Minutes of 294th Meeting of Registration Board | 1
MINUTES OF 294th MEETING OF REGISTRATION BOARD
HELD ON 9th April, 2020. *=*=*=*=*
Item No. Detail of Item Pages
I. Confirmation of Minutes of 293rd meeting of Registration Board 04
II. Division of Pharmaceutical Evaluation & Registration.
Pharmaceutical Evaluation Cell (PEC) .... ...... ...... .........
Registration-I .......... ............. ............. ............. ......... …
Import & Vet-I-II ……………………………………....
Post Registration-I.……………………………………..
5 – 408
5-347
348-349
350-352
353-355
III. Division of Biological Evaluation & Research 356 – 359
IV. Division of Quality Assurance & Laboratory Testing 360 – 369
Drug Regulatory Authority of Pakistan
T.F. Complex, Mauve Area, G-9/4
Islamabad.
Minutes of 294th Meeting of Registration Board | 2
294th meeting of Registration Board was held on 9th April, 2020 in the Committee Room,
Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The meeting was chaired by
Dr.Obaidullah, Director, Pharmaceutical Evaluation & Registration Division, DRAP. The meeting
started with recitation of the Holy Verses.
The Chairman apprised that like rest of the world, Pakistan is also facing various challenges
due to Pandemic COVID-19. Government of Pakistan is striving to provide the best possible relief
to the public in general and COVID-19 patients in particular. In this regard, functional and
operational DRAP has been stressed from the highest level under this existing situation of Force
Majoure. DRAP has decided to convene various meetings viz. Central Licensing Board,
Registration Board, Clinical Study Committee, Enlistment Committee, Coordination with
provincial governments and stakeholders on priority through video link to address matter of public
health importance. Accordingly, instant meeting of Registration Board has been convened.
Following members attended the meeting.
1. Maj.Gen. (R) Dr. Tahir Mukhtar Sayed,
Inspector General (Hospitals), Fauji Foundation, Rawalpindi
Member
2. Dr. Qurban Ali, Ex-Director General,
National Veterinary Laboratories, Islamabad
Member
3. Dr. Muhammad Khalid Jawed, Director,
Drugs Testing Laboratory,Peshawar Government of Khyber Pakhtunkhwa
Member
4. Mr. Muhammad Aslam, Deputy Draftsman-II,
Representative of Ministry of Law & Justice, Islamabad
Member
5. Mr. Ghulam Mujtaba, Deputy Director (Patent)
Representative of IPO, Islamabad.
Member
6. Dr. Noor-us-Saba, Director,
Biological Evaluation & Research Division, DRAP
Member
7. Mr. Abdullah,
Additional Director (PE&R), DRAP.
Member/
Secretary
Following members attended the meeting via video link.
8. Dr. Rafeeq Alam Khan, Meritorious Professor,
Faculty of Pharmacy, Ziauddin University, Karachi.
Member
9. Lt.Gen.(R) Prof.Dr. Karamat Ahmed Karamat (HI-M, SI-M)
Former Surgeon General Pakistan
Member
10. Mr. Iftikhar A.Choudhary,
Hospital Pharmacist, Lahore
Member
11. Dr. Amanullah Khan, Director,
Drugs Testing Laboratory, Quetta. Government of Balochistan
Member
Minutes of 294th Meeting of Registration Board | 3
12. Syed Adnan Rizvi, Director,
Drugs Testing Laboratory, Karachi. Government of Sindh
Member
13. Mr. Muzammil Waheed, Director,
Drugs Testing Laboratory, Faisalabad, Government of Punjab
Member
14. Dr. Hafsa Karam Ellahi, Additional Director,
Representative of QA< Division, DRAP
Member
Mr. Asif Jalil, Incharge PEC with respective Assistant Directors presented the agenda of
PE&R Division. Director, BE&R assisted by respective Assistant Directors presented the agenda
of BE&R Division. Mr. Kashif Khan and Shahid Nawaz Assistant Director presented the agenda
of QA & LT Division.
Mr. Hamid Raza, Mr.Tipu Sultan Akram (PPMA), Mr. Nadeem Alamgir (Pharma Bureau)
and Mr. Khalid Saeed (PCDA) attended the meeting as observers on behalf of their respective
associations.
Minutes of 294th Meeting of Registration Board | 4
Item No. I: Confirmation of Minutes of 293rd Meeting of Registration Board.
293rd meeting of Registration Board was held on 6th – 8th 2020. Initially partial draft
minutes were circulated among the members on 9th January, 2020 & 3rd February, 2020. All
members agreed and approved the said minutes. Two members commented on the minutes as
under:
Comments of Syed Adnan Rizvi
Dear Sir,
Futher permission of furhter 30 months for contract manufacturing of M/s. Novartis Pharma is the
sheer violation of rule 20 A (1) (c) of the Drugs (LRA) Rules 1976. Previously permission was
granted on special case to the Novartis Pharma which has been expired, according to law no
permission could be granted. Therefore no question of consideration of fresh application and
dealing as fresh application.
There is a need of amendment in Rule 20 A (1)(c) of the Drugs(LRA) Rules 1976 otherwise this
application for further extension could not be proceeded. It is worth mentioning that none of all 39
products are life saving drugs and there are several me too products are available in the market
manufacturing by national pharmaceuticals companies.
I disagree with the approval of contract manufacturing, as it is a sheer violation of Drugs (LRA)
Rules 1976.
Regards
Syed Adnan Rizvi
Member RB/ Director
Drug Testing Laboratory Sindh
Karachi
Comments of Iftikhar Ahmed
Asslamo allikum.
Thanks for sending partial draft minutes of above meeting.
For Novartis case, my opinion is that they should be given further chance to have contract
manufacturing for the requested period with the condition that they are bound to inform the board
about the progress on the manufacturing facility.
Agreed on the decision of all other cases as you have suggested.
Iftikhar ch
It is pertinent to mention that Syed Adnan Rizvi was not present in the meeting, the day on
which Novartis case was discussed. Further, all present approved the partial draft minutes so fair
minutes were approved by the Chairman Registration Board and circulated to all concerned for
implementation.
After that complete draft minutes of the meeting of Registration Board were circulated
among the members of the Board on 11th February, 2020 for perusal/approval and comments (if
any) within five days.
None of the members disagreed the complete draft minutes. Accordingly, fair minutes were
approved by the Chairman Registration Board and circulated to all concerned for implementation.
Decision: Registration Board confirmed minutes of 293rd meeting
Minutes of 294th Meeting of Registration Board | 5
Item No. II Division of Pharmaceutical Evaluation & Registration
Pharmaceutical Evaluation Cell (PEC)
Item No. 1: Priority approval / registration of drugs during the COVID-19 Pandemic
Agenda of Evaluator PEC-I (Mr. Farooq Aslam)
Agenda of Evaluator PEC-II (Mr. Ammar Ashraf Awan)
Agenda of Evaluator PEC-III (Mr. Muhammad Haseeb Tariq)
Agenda of Evaluator PEC-IV (Ms. Farzana Raja)
Agenda of Evaluator PEC-V (Ms. Iqra Aftab)
Agenda of Evaluator PEC-VI (Mr. Umar Latif)
Agenda of Evaluator PEC-VIII (Ms. Haleema Sharif)
Agenda of Evaluator PEC-IX (Mr. Hanifullah)
Agenda of Evaluator PEC-XI (Mr. Farhadullah)
Agenda of Evaluator PEC-XIV (Mr. Muhammad Ahsan Hafiz)
Minutes of 294th Meeting of Registration Board | 6
Item No. II Division of Pharmaceutical Evaluation & Registration.
Item No. I: Priority approval / registration of drugs during the COVID-19 Pandemic.
Background:
The world is currently facing one of the biggest public health outbreak of coronavirus disease
2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-
CoV-2). The outbreak was first identified in Wuhan, Hubei, China, in December 2019. The World
Health Organization (WHO) declared the outbreak to be a Public Health Emergency of
International Concern on 30th January 2020 and recognized it as a pandemic on 11th March
2020. More than 723,500 cases of COVID-19 have been reported in over 190 countries and
territories, resulting in approximately 34,000 deaths till date.
Many clinical trials are under way for treatment / prevention of COVID-19 which uses different
type of pharmaceutical / biological drugs. Many drugs have been allowed for investigational use
in hospitals under medical care for the COVID-19 patients.
The authorities from all over the world have considered the use of several drugs under their
respective national emergency management plans. Clinical Management Guidelines for COVID-
19 Infections issued by Ministry of National Health Services, Regulation & Coordination
(available at http://covid.gov.pk/guideline) also recommends the use of these drugs in the
management of mild to moderate and severe cases of COVID-19 patients. Further, USFDA has
also given Emergency Use Authorization for chloroquine and hydroxychloroquine tablets for
COVID-19 patients (available at: https://www.fda.gov/media/136534/download). Further Centers
for disease control and prevention (CDC) USA also issued Information for Clinicians on
Therapeutic Options for Patients with COVID-19(available at:
https://www.cdc.gov/coronavirus/2019-ncov/hcp/therapeutic-options.html).Similarly Italian
Medicines Agency (AIFA) considers it essential to provide clinical elements useful to guide the
prescription and to define, for each drug used, a relationship between benefits and risks for the
individual patient. Off-label use is only permitted under the national emergency management plan
for treatment of COVID-19 by using Lopinavir / ritonavir (available at:
https://www.aifa.gov.it/emergenza-covid-19).
Keeping in view the above information, Drug Regulatory Authority of Pakistan (DRAP),
exercising its powers under Rule 26of Drugs (LRA) Rules amended via SRO 713(1)/2018 dated
8th June, 2018, has made following decision in its meeting dated 3rd April, 2020.
1. Allowed to submit registration application on form 5, form 5A, form 5D or form 5E instead
of form 5F for following formulations as approved by the reference regulatory authorities;
a. Chloroquine Phosphate
b. Hydroxychloroquine Sulfate
c. Lopinavir/Ritonavir
d. Oseltamivir
e. Ascorbic Acid
2. The applicant can submit their application till 2nd May 2020.
3. These applications will be considered out of queue.
Minutes of 294th Meeting of Registration Board | 7
4. The validity of registration period for above mentioned drugs registered during this time
will be one year only.
5. The registration holder will submit data of product development of 3 and 6 months within
one year. The data will be considered by Registration Board for extension of validity period
of registration for further period.
6. Applicant shall submit affidavit for compliance of point 4 and 5 above.
Discussion:
Registration Board deliberated upon the current situation of Covid-19 pandemic and realized the
extraordinary circumstances where in no treatment therapy has yet been approved by any of the
reference regulatory authorities while several drugs have been recommended by various agencies
for investigational use in hospitals under medical care for the management of Covid-19 patients.
Registration Board was also apprised regarding the various regulatory waivers which have been
granted by reference regulatory authorities at national level to make these investigational drugs
readily available. Considering the situation of public health emergency where in getting the
potentially life-saving investigational medicines to the patients is of paramount importance,
Registration Board deliberated upon various regulatory flexibilities offered in the above cited
decision of Drug Regulatory Authority of Pakistan and considering the dire need of ensuring
timely availability of possible treatment options for Covid-19 patients the Board decided as under:
Decision:
a. The registration applications of following formulations, as approved by Reference
Regulatory Authorities, will be considered out of queue on priority basis:
Chloroquine Phosphate
Hydroxychloroquine Sulfate
Lopinavir/Ritonavir
Oseltamivir
Ascorbic Acid
b. As present, registration applications are without product development and stability
data, thus registration shall be valid for 01 year only and the registration holder shall
perform product development including stability studies for 6 months as per
intervals and data requirements decided by Registration Board in 293rd meeting and
shall submit to PE&R Division within one year time for consideration by
Registration Board for extension of validity period of registration for further period.
The same shall be applicable for the 5D applications of above formulations.
c. Registration Board also clarified that no therapeutic claim regarding treatment of
COVID-19 shall be made for above formulations until unless approved by any
Reference Regulatory Authority and the same is approved by Registration Board as
well. Presently above formulations shall only be used as part of the clinical trials or
its management of COVID-19 under strict supervision of relevant medical experts.
d. Registration Board further directed to issue an advisory wherein self-medication
and other related matters related to COVID-19 shall be addressed.
Minutes of 294th Meeting of Registration Board | 8
With reference to the decision of Drug Regulatory Authority of Pakistan, following
applications were received and evaluated by PEC and now presented before the Board.
Registration Board considered these applications in light of its above cited decision:
1. Hydroxychloroquine sulfate Tablet 200mg:
Composition: Each Film Coated Tablet contains:
Hydroxychloroquine sulfate……200mg
Reference Regulatory Authority status: PLAQUENIL 200mg film coated tablet by M/s Concordia, USFDA Approved.
Generic status: HCQ 200 Tablets by M/s Getz Pharma, Reg. No. 45471
Specifications: USP Specification Sr.
No.
Name of applicant Brand Name composition Diary no. /
Date / fee /
form
Pack
Size /
Price
Remarks/GMP status
1. M/s Ferozsons
Laboratories Ltd. P.O
Ferozsons,Amangarh,
Nowshera-Khyber
Pakhtunkhwa
Quinovid
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5221
224/03/2020
Rs. 20,000/-
Form 5
30’s,
price
Rs.
11.50/-
per
tablet
Panel inspection dated
25-01-2019 concluded
that panel recommends
the grant of GMP
certificate.
2. M/s Genix pharma
Private Limited,
Karachi.
Oxyquine
tablet 200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5231
24/03/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 10/04/2019,
acceptable level of
compliance GMP
guidelines.
3. M/s Standpharm
Pakistan (Pvt) Ltd.
Lahore.
Acron
Tablet
200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5230
24/03/2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP inspection
was conducted on 19-
10-2017 and the report
concludes a satisfactory
level of GMP
compliance.
4. M/s Aries
Pharmaceuticals 1-W,
Industrial Estate
Hayatabad Peshawar.
H-quin
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy. No. 5771
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 10/3/17, panel
recommended for grant
of GMP certificate.
5. M/s Briel
Pharmaceuticals (Pvt)
Ltd. 538-C, Sundar
Industrial Estate
Lahore.
Hydroquin
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy. No. 5771
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 24/05/2019, firm
was found to be
operated at satisfactory
level of GMP
compliance.
6. M/s Seraph
Pharmaceuticals,
Plot# 210, Industrial
Triangle, Kahuta
Road, Islamabad.
S-Chlor
Tablet
200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5283
25/03/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP certificate issued
on the basis of
inspection conducted
on 11/07/2019.
7. M/s Caliph
Phrmaceuticals (pvt)
Ltd. Plot No. 17,
special industrial zone
(EPZ), Risalpur,
KPK.
HC-CAL
Tablet
200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5850
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 06/11/2018, the
panel recommended
renewal of DML.
Minutes of 294th Meeting of Registration Board | 9
8. M/s Quaper pvt. Ltd.
26-A Samll industrial
estate Lahore road
Sargodha.
Hy-Quine
tablet 200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5882
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 28/01/2019, the
panel recommends the
renewal of DML.
9. M/s Focus & Rules
Pharmaceuticasl (pvt)
Ltd. 44-industrial
triangle Kahuta Road,
Islamabad.
FoQuin
tablet 200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5294
26/03/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP certificate issued
on 18/03/2019.
10. M/s Aulton
Phamraceutical, plot #
84/1, Block A, Phase
V, Industrial Estate
Hattar.
Aultaquil
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy. No. 5942
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm was last
inspected on
13.02.2018, the firm
was operating at good
level of compliance
with cGMP guidelines
11. M/s Glitz Pharma,
plot No. 265,
industrial triangle
Kahuta Road
Islamabad.
Quinglit
tablet 200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5298
26/03/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report,
16th Jan, 2019, the panel
recommended issuance
of GMP certificate.
12. M/s Bio-Mark
Pharmaceuticals, plot
No. 527-sundar
industrial estate,
Lahore.
Bio-HCQ
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5320
27/03/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm was GMP
compliant on the day of
inspection dated
13/02/2020
13. M/s Genetics
Pharmacetuicasl (Pvt)
Ltd, 539-A, Sundar
Industrial Estate,
Raiwind, Lahore.
Coviquine-H
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5367
30/03/2020
Rs. 20,000/-
As per
SRO
Last inspection report
dated 29/03/2019, firm
was operation at
satisfactory level of
GMP compliance.
14. M/s Scotmann
Pharmaceuticasl, 5-D,
I-10/3, Industrial
Area, Islamabad.
Hystat tablet
200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5256
30/03/2020
Rs. 20,000/-
Form 5
As per
SRO
Last Inspection report
dated 17-18/11/2018,
panel recommended
regularization of
revised layout & grant
of renewal of license.
15. M/s Navegal
Laboratoriesd, 41/1-
A2, Phase-I,
Industrial Estate
Hattar.
Navequin-H
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5409
31/03/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 11/03/2017, GMP
was satisfactory.
16. M/s Polyfine
Chempharma, 51
Industrial Estate,
Hayatabad Peshawar.
Malaquine-
H 200mg
Tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 541
31/03/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 24/02/2019, firm
is consider4ed to be
operating at satisfactory
level of GMP
compliance.
17. M/s Scilife Pharma
(pricate) Limited,
Plot#FD-57/58-A2,
Korangi Creek
Industrial Park,
(KCIP) Karachi.
Hydroxychl
oroquine
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5407
31/03/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 24/4/19,
Acceptable level of
good compliance with
GMP guidelines.
Minutes of 294th Meeting of Registration Board | 10
18. M/s Honig
Pharmaceuticals
Laboratories, 14km
Adyala Road,
Rawalpindi.
MCQ
200mg
Tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5412
31/03/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP certificate issued
on 15th
April, 2019.
19. M/s Cher Wel
Pharmacetuicals, Plot
No.20 Phase 4, Hattar
Industrial Estate,
Hattar KPK.
Quinoline
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5421
01/04/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP certificate issued
on 26th March, 2019 on
the basis of inspection
conducted on
04/02/2019.
20. M/s Pharmix
Laboratories (pvt)
Ltd. 21km Ferozpur
Road Lahore.
Cydro
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5423
01/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 13/09/2019, The
panel recommended
renewal of DML.
21. M/s Dyson Research
Laboratories Pvt Ltd.
28 km Ferozepur
Road Lahore
Dyquin
Tablets
200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200 mg
Dy.No 41779
07-12-2018
Rs.20,000/-
Form 5
As per
SRO
11-01-2019 satisfactory
level of GMP
compliance, hence
panel recommended
issuance of GMP
certificate to the firm.
Some advises were also
given in the report to the
firm for further up
gradations.
22. M/s Wnsfeild
Pharmaceuticals,
Plot#122, Phase V,
Block A, Industrial
Estate Hattar.
Hydroqin
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No 39683
03-12-2018
Rs.20,000/-
Form 5
As per
SRO
Last GMP inspection
conducted on
18/01/2018 wherein
renewal of DML was
recommended.
23. M/s Pharm Evo Pvt
Ltd, A-29, North
West Industrial Zone,
Light Industrial Zone,
Port Qasim, Karachi
Evoquin
plus 200mg
tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No 5589
06-04-2020
Rs.20,000/-
Form 5
As per
SRO
Panel inspection dated
07-02-02019
recommended issuance
of GMP certificate.
24. M/s Vision
Pharmaceuticals, Plot
No.22-23, Industrial
Triangle, Kahuta
Road, Islamabad
Visoquin-H
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No 5561
06-04-2020
Rs.20,000/-
Form 5
As per
SRO
Last inspection dated
11-02-2019 concluded
GMP compliance
25. M/s Paramount
Pharma, Plot No.36,
Indus. Triangle
Kahuta Road,
Islamabd.
Paraquin
tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate..….200mg
Dy. No 5573
06-04-2020
Rs.20,000/-
Form 5
As per
SRO
Last inspection dated
08-02-19 concluded
keeping in view the
observations noticed
during inspection as
narrated above, the
panel is of opinion that
firm may be allowed to
start manufacturing in
the light of GMP
guidelines
26. M/s Invictus
Pharmaceuticals, Plot
No.21,26, NS2,
RCCI, Rawat,
Islamabad
I-Quin
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate..….200mg
Dy. No 5571
06-04-2020
Rs.20,000/-
Form 5
As per
SRO
Issuance of DML on
08-01-2019
Minutes of 294th Meeting of Registration Board | 11
27. M/s Davis
Pharmaceutical Labs
121 Industrial
Triangle Area, Kahuta
Road, Islamabad.
Coronaquine
tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate ..…. 200mg
Dy. No 5553
06-04-2020
Rs.20,000/-
Form 5
As per
SRO
GMP certificate issued
on basis of inspection
conducted on 01-10-
2019
28. M/s Global
Pharmaceuticals, Plot
No 204-205, Kahuta
Triangle, Industrial
Area, Islamabad.
Quinex
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate ..…. 200mg
Dy. No 5557
06-04-2020
Rs.20,000/-
Form 5
As per
SRO
GMP certificate issued
on basis of inspection
conducted on 01-10-
2019
29. M/s Sapient Pharma,
123-S Industrial Area
, Kot Lakhpat, Lahore
Sadroxi
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate ..…. 200mg
Dy. No 5784
07-04-2020
Rs.20,000/-
Form 5
As per
SRO
Panel inspection dated
19-9-2019 & 18-11-
2019 recommended
renewal of DML.
30. M/s Cunningham
Pharmaceuticals (Pvt)
Ltd. Plot#81 Sundar
Industrial Estate
Raiwind Road,
Lahore
H-Curine
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5545
Dated
06/04/2020
Rs. 20,000/-
As per
SRO
Firm has maintained
conformance to GMP
compliance as per
inspection report dated
01/04/2019.
31. M/s Metro
Pharmaceuticals
Plot#14, St.No. SS-2,
National Industrial
Zone, Rawat,
Islamabad.
M-Quin
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy. No. 5581
Dated
06/04/2020
Rs. 20,000/-
As per
SRO
The panel
recommended renewal
of DML, inspection
date 17/05/2019
32. M/s Wimits Pharma
(Pvt) Ltd. Plot#129,
Sundar Industrial
Estate (PIE) Raiwind
Road Lahore.
COV-HCQ
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5542
Dated
06/04/2020
Rs. 20,000/-
As per
SRO
GMP Certificate issued
on 10-12-2018.
33. M/s Aims
Pharmaceuticals,
Plot#291 Industrial
Triangle Kahuta
Road, Islamabad.
Hydro-Q
tablet 200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5531
Dated
06/04/2020
Rs. 20,000/-
As per
SRO
Panel recommended
renewal of DML, dated
31/05/2018.
34. M/s MartinDow Ltd,
Plot#37, Sector 19,
Korangi Industrial
Area Karachi.
Clordow-H
tablet 200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5533
06/04/2020
Rs. 20,000/-
As per
SRO
Firm was operating at
good level of
compliance with GMP
as per inspection report
dated 06/12/2018.
35. M/s Don valley
Pharmaceuticasl (Pvt)
Ltd. 31-KM Main
Ferozpur Road
Lahore.
DV-Quine
tablet 200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5516
02/04/2020
Rs. 20,000/-
As per
SRO
Good compliance of
GMP, inspection date
13/02/2020.
36. M/s Zafa
Pharmaceuticals
Laboratories (Pvt)
Ltd., L1/B Block-22
federal B Industrial
area, Karachi.
Hydroquin
tablet 200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No.5529
Dated
06/04/2020
Rs. 20,000/-
As per
SRO
GMP certificate issued
on 05/09/2019.
Minutes of 294th Meeting of Registration Board | 12
37. M/s The Searle
company Limited, F-
319 SITE Karachi,
Pakistan
Qoroze-H
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No.55278
06/04/2020
Rs. 20,000/-
As per
SRO
GMP certificate issued
on 22/07/2019.
38. M/s Tabros Pharma
(Pvt) Ltd, L-20/B,
Sector-22 Federal B
Industrial Area,
Karachi.
Coronaz
200mg
Tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No.55280
Dated
06/04/2020
Rs. 20,000/-
As per
SRO
Last inspection report
dated 28/8/19, current
GMP compliance level
is rated as good.
39. M/s Crystolite
Pharmaceuticals,
Plot#1&2, St.#S-2,
National Industrial
Zone, Rawat,
Islamabad.
Quenil
200mg
tablets
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No.
11228 dated
07/03/2019
Rs. 20,000/-
Form 5
As per
SRO
DML renewed vide
letter No.F.1-54/2009-
Lic (Vol-I) dated 6th
March 2019.
40. M/s Bio-Labs (Pvt)
Ltd., Plot No. 145
Industrial Triangle
Kahuta Road,
Islamabad.
Hydro-Q
200 tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5440
dated
01/04/2019
Rs. 20,000/-
Form 5
As per
SRO
GMP certificate issued
on 21/05/2019.
41. M/s Linear Pharma,
Plot No. 18, Street #S-
4, National Industrial
Zone (RCCI) Rawat
Islamabad.
Malaram
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5439
dated
01/04/2019
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 30/01/2019,
satisfactory level of
GMP compliance.
42. M/s MartinDow
Marker Ltd. (formerly
Meck (Pvt) Ltd) 7,
Jail Road, Quetta.
Covoquin-H
tablets
200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5779
Dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm’s GMP
compliance level is
rated as good as pe the
inspection report dated
12/07/2019.
43. M/s Neutro Pharma
(Pvt) Ltd. 9.5 KM,
Sheikhupura Road,
Lahore.
Neudrox
Tablets
200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.#13978
07/03/2019
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 18/7/17, fair
levelof GMP
compliance.
44. M/s Medisynth
Pharmaceuticals (Pvt)
Ltd. Plot#55 St.S-5,
NIZ, Rawat.
Marquin
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No.5788
07/04/2019
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
01/03/2019,
satisfactory level of
GMP.
45. M/s Medpharm
Research Lab, 28 km,
Ferozpur Road,
Lahore.
MED-HC
tablet 200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 6181
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
DML issued on
26/02/2018.
46. M/s Masfa Industries
17km, Sheikhupura
Road, Lahore.
MSQ 200mg
tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 6173
08/04/2020
Rs. 20,000/-
(20,000×2)
One challan
of Rs.
40,000/- is
attached in
Masfaquine
tablet.
Form 5
As per
SRO
Last inspection report
dated 29/03/2019, good
level of GMP
compliance.
Minutes of 294th Meeting of Registration Board | 13
47. M/s Hygeia
Pharmaceuticals,
Industrial Triangles
Kahuta Road
Islamabad.
Hysul
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5864
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
21/09/2017,
satisfactory level of
GMP compliance.
48. M/s Aurik
Pharmaceuticals,
Plot#6&7, St#S-9
National Industrial
Zone, Rawat
Islamabad.
Coronil-H
200mg
Tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5795
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 05/09/2018, the
firm was complying
with GMP standards.
49. M/s CKD
Pharmaceuticals
Pakistan (Pvt),
Karachi.
Daraquine-
OX Tablet
200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 6165
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 11/10/2019, good
compliance
50. M/s Hiranis
Pharmaceuticals (Pvt)
Ltd. Plot#E-145 to E-
149, North Western
Industrial Zone, PQ,
Karachi.
Coviquine
Tablet
200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5770
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 29/01/2019, the
firm is overall GMP
compliant.
51. M/s Rasco Pharma,
5.5 KM Raiwind
Road, Lahore.
Hydrovid
tablet 200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5802
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 04/2/19, panel
recommended renewal
of DML.
52. M/s Next
Pharmaceutical
Products (Pvt) Ltd.,
Plot No.44 A-B,
Sundar Industrial
Estate, Lahore.
Chloronext
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 6154
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP certificate issued
on 08/07/2019.
53. M/s Qintar
Pharmaceutical, 14-
A, Small Industrial
Estate, Lahore Road,
Sargodha.
H-Queen
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5849
07-04-2020
Rs. 20,000/-
Form 5
As per
SRO
GMP inspection dated
24-5-2019 which
concludes as:
Firm has improved a lot
of observations and
showed Good intention
to improve further.
54. M/s Biogen Pharma,
8-KM, Rawat Chak
Beli Road,
Rawat, Rawalpindi.
Q-gen
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy. No. 5873
dated 07-04-
2020 Rs.
20,000/-
Form 5
As per
SRO
GMP inspection dated
18-08-2017 which
concludes as:
Keeping in view the
above facts, overall
GMP compliance found
GOOD as of today
management has been
advised to continue the
process of up gradation
and submit compliance
report on observations
made within two weeks
positively especially
sterile area.
Minutes of 294th Meeting of Registration Board | 14
55. M/s Munawar
Pharma. Pvt Ltd, 31-
Km, Multan Road,
Lahore.
Hydroxyqui
n tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5890
07-04-2020
Rs. 20,000/-
Form 5
As per
SRO
GMP certificate issued
based on the inspection
dated 7-11-2017
56. M/s EG
Pharmaceuticals,
Industrial Triangle
Kahuta Road,
Islamabad.
Oxychloro
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5924
07-04-2020
Rs. 20,000/-
Form 5
As per
SRO
Renewal of DML
recommended in the
inspection dated 13-02-
2019
57. M/s Pharmasol (Pvt)
Ltd. Plot No. 549,
Sundar Industrial
Estate, Raiwind Road,
Lahore.
Quinovid-H
tablet 200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 6137
08-04-2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection dated
08-07-2019 & 25-07-
2019 concluding
satisfactory level GMP
compliance.
58. M/s. Athan
Pharmaceuticals,
Plot#84/1, Block B,
Phase V, Industrial
Estate, Hattar.
Athquin
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy. No. 5955
07-04-2020
Rs. 20,000/-
Form 5
As per
SRO
New DML issued on 5-
03-2019.
59. M/s Albro Pharma
Private Limited.
340-S Industrial state,
Kot Lakhpat, Lahore,
Pakistan.
Quinbro
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy. No. 6230
08-04-2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP dated 30-05-
2019 concluding that
firm is complying most
of the GMP guidelines.
60. M/s Sami
Pharmaceuticals, S-
95, SITE, Karachi.
Quinco
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy. No. 6168
08-04-2020
Rs. 20,000/-
Form 5
As per
SRO
GMP certificate issued
on 14-6-2018.
61. M/s MKB
Pharmaceutical Pvt.
Ltd. 66-Hayatabad
Industrial Estate,
Jamrud Road,
Peshawar.
Covigon
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy. No. 6166
08-04-2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP inspection
conducted on 01-2-
2018 & report
concludes that overall
the firm was working at
satisfactory level of
GMP compliance."
62. M/s Horizon Health
Care Pvt Ltd, Plot
No.35-A, Small
Industrial Estate,
Taxila, Rawalpindi.
Hydrozon
200mg tablet
Each film coated
tablet contains:
Hydroxychloroquine
sulfate ……. 200mg
Dy. No. 6174
08-04-2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP inspection
was conducted on 25-
06-2018 and the report
concludes that company
has shown good
response and rectified
problems & has shown
good compliance as per
schedule B-II.
63. M/s Fresh
Pharmaceuticals,
Plot# 07, Street S-6
National Industrial
Zone Rawat,
Islamabad
Cronofate
Tablet
200MG
Each film coated
tablet contains:
Hydroxychloroquine
sulfate…….200mg
Dy.No. 5905
dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP inspection report
dated 02-10-2019 is
complying satisfactory
level of cGMP as of
today.
64. M/s Valor
Pharmaceuticals,
124/A, Triangle
Industrial Estate,
QUIT
TABLET
200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5889
dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP inspection report
dated 20-04-2018
recommended renewal
of DML.
Minutes of 294th Meeting of Registration Board | 15
Kahuta Road,
Islamabad.
65. M/s Winlet
Pharmaceuticals, 30-
km, Lahore Sargodha
Road, Lahore.
WIN-CQ
TABLET
200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 6126
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm is granted
New DML based on
inspection dated 05-12-
2017.
66. M/s. Sayyed
Pharmaceutical
Industries (Pvt) Ltd.,
Plot#67/2, Phase 3,
Industrial Estate,
Hattar
CRONOSY
D TABLET
200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5796
dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Inspection conducted
on 04-09-2019, firm
operates at satisfactory
level of GMP
guidelines.
67. M/s HIMARK
Laboratories (Pvt.)
Ltd., Plot#37-A,
Sundar Industrial
Estate, Lahore
QUINMAR
K TABLET
200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No. 5780
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
New License
68. M/s Hamaz
Pharmaceuticals
(Pvt.) Ltd. 13-Km,
Bosan Road,
Lutfabad, Multan
HYDRO-Q
TABLET
200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No.5911
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Firm is granted GMP
certificate based on
inspection conducted
on 28-09-2019.
69. M/s Kaizen
Pharmaceuticals
(Pvt) Ltd., E-127-
129, North Western
Industrial Zone, Bin
Qasim, Karachi
Hydroquin
TABLET
200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No.5868
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Firm is granted GMP
certificate based on
inspection conducted
on 28-8-2019.
70. M/s Linta Pharma
(Pvt) Ltd. Plot # 03,
St#S-5, Rawat
Industrial Estate,
Islamabad
LCQ
TABLET
200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy.No.5869
dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP inspection was
conducted on 12-06-18
and the report
concludes the firm to be
GMP complaint.
71. M/s Gray’s
Pharmaceutical,
Plot#2,St.#N-3,
National Industrial
Zone, Rawat
HIQUIN
TABLET
200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy. No. 5866
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Inspection conducted
on 23-05-2019 overall
GMP compliance
graded as Good.
72. M/s Moringa
Pharmaceuticals, 35-
A Sundar Industrial
Estate, Lahore
HCQ Tablet
200mg
Each film coated
tablet contains:
Hydroxychloroquine
sulfate….200mg
Dy. No. 6277
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm is granted
GMP certificate based
on inspection
conducted on 30-5-
2019.
73. M/S Pulse
Pharmaceuticlas (Pvt)
Ltd. Raiwind Road
Lahore.
Qunodrox
200mg
Tablet
Each Film Coated
Tablet contains:
Hydroxychloroquine
sulfate……200mg
Dy.No. 5226
24/03/2020
Rs. 20,000/-
Form 5
As per
SRO
Certificate of cGMP is
issued to the firm based
on evaluation conducted
on 10th May, 2017
74. M/s Searle IV
Solutions (Pvt) Ltd.
1.5km, Manga Raiwind
Road, Lahore
Macdoquine
200mg
Tablet
Each Film Coated
Tablet contains:
Hydroxychloroquine
sulfate……200mg
Dy.No. 6135
24/03/2020
Rs. 20,000/-
Form 5
As per
SRO
27-02-2018. GMP
Certificate issued on 15-
03-2018.
Minutes of 294th Meeting of Registration Board | 16
75. M/s Olive
Laboratories, 52-56
National Industrial
Zone, Rawat,
Rawalpindi
Hydroquine
200mg
Tablet
Each Film Coated
Tablet contains:
Hydroxychloroquine
sulfate……200mg
Dy.No. 6133
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Inspection report dated
05-03-2019 confirms
firm is operating in
compliance with GMP
76. M/s NabiQasim
Industries (Pvt) Ltd.
17/24, Korangi
Industrial Area,
Karachi.
Miniquin-H
Tablets
200mg
Each Film Coated
Tablet contains:
Hydroxychloroquine
sulfate……200mg
Dy.No. 6140
dated
24/03/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 02/08/2018
concludes that GMP
compliance as good.
77. M/s Saibins
Pharmaceuticals,
Plot#316, Industrial
Triangle, Kahuta Road,
Islamabad
H Quine
Tablets
Each Film Coated
Tablet contains:
Hydroxychloroquine
sulfate……200mg
Dy.No. 6142
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP certificat4e issued
on 17/01/2019 on the
basis of inspection
conducted on
24/12/2018.
78. M/S Indus Pharma
(Pvt) Ltd., Plot No. 26,
27,63, 64, 65, 66 & 67,
Sector-27, Korangi
Industrial Area,
Karachi.
Doquine-S
200mg
Tablet
Each Film Coated
Tablet contains:
Hydroxychloroquine
sulfate……200mg
Dy.No. 6146
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection was
conducted on 16-8-2017
& report concludes that
firm was considered to be
operating at an
acceptable level of GMP
compliance.
79. M/s Prays
Pharmaceuticals,
Plot#10, St.#SS-4,
National Industrial
Zone (RCCI) Rawat,
Islamabad
Prayquine
200mg
Tablet
Each Film Coated
Tablet contains:
Hydroxychloroquine
sulfate……200mg
Dy.No. 5858
dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Overall Evaluation of the
Inspection Report is
rated as Good.
80. M/s Wenovo
Pharmaceuticals
Plot#31& 32 Punjab
Small Industrial Estate
Taxila Pakistan
Hydroqin
200mg
Tablet
Each Film Coated
Tablet contains:
Hydroxychloroquine
sulfate……200mg
Dy.No. 6291
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP inspection
conducted on 30-9-2018
& 29-10-2018 and report
concludes that Firm is
compliant to current
GMP
81. M/s Reliance Pharma
Plot No. 8, Street No.
S-8 Rawat Islamabad.
Reliquine
200mg
tablet
Each Film Coated
Tablet contains:
Hydroxychloroquine
sulfate……200mg
Dy.No. 6265
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 09/01/2020, the
basic elements of GMP
compliance are in place.
82. M/s Saaf
Pharmaceuticals, Plot
No. 15, Special
Industrial Zone,
Risalpur, KPK
Hydquin
Tablet
200mg
Each Film Coated
Tablet contains:
Hydroxychloroquine
sulfate……200mg
Dy.No. 6270
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Inspection report dated
20-2-2019, the panel
recommended the
resumption of
production.
83. M/s Islam
Pharmaceuticals, 7km,
Pasrur Road, Sialkot
Clorox
Tablet
200mg
Each Film Coated
Tablet contains:
Hydroxychloroquine
sulfate …… 200mg
Dy.No. 6225
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
New License (letter
issuance date: 29th
August 2018)
84. M/s Medera
Pharmaceuticals Pvt
Ltd, Plot #2, Street #4,
National Industrial
Zone, Rawat,
islamabad
Medoxiquin
e 200mg
Tablet
Each Film Coated
Tablet contains:
Hydroxychloroquine
sulfate……200mg
Dy.No. 6229
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP inspection
conducted on 07-11-
2018 and report
concludes that overall
GMP compliance is
found Good of today.
Minutes of 294th Meeting of Registration Board | 17
85. M/s Amros
Pharmaceuticals, A-96,
S.I.T.E. Super
Highway, Karachi.
Amroxy Q
200mg
Tablet
Each Film Coated
Tablet contains:
Hydroxychloroquine
sulfate……200mg
Dy.No. 6247
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 18/07/2018
confirms current
compliance level as
Good.
86. M/s Allmed Pvt Ltd.
Plot No. 590, Sundar
Industrial Estate,
Lahore, Pakistan
Oxyquin
tablet
200mg
Each film coated tablet
contains:
Hydroxychloroquine
sulfate ……. 200mg
Dy.No.6235
08-04-2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP inspection
conducted on 01-01-
2020 and report
concludes GMP
compliance.
87. M/s Welwrd
Pharmaceuticals, Plot
#03, Block A, PhaseI-
II, Industrial Estate,
Hattar
QLORON
200mg
tablet
Each film coated tablet
contains:
Hydroxychloroquine
sulfate……200mg
Dy.No. 6281
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Inspection conducted
on 12-11-2018 the firm
is operating at
satisfactory level of
GMP.
88. M/s Winbrains
Research Labs, Plot#
69/1, Block B, Phase I-
II, Industrial Estate,
Hattar
Hydrowin
200mg
Tablet
Each film coated tablet
contains:
Hydroxychloroquine
sulfate…….200mg
Dy.No. 6279
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm is granted
GMP certificate based
on inspection
conducted on 20-05-
2019.
89. M/s Benson
Pharmaceuticals,
Plot# 3, Main Road,
National Industrial
Zone, Rawat
Hydroxychl
oroquine
200mg
Tablet
Each film coated tablet
contains:
Hydroxychloroquine
sulfate…….200mg
Dy.No. 6271
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Inspection conducted
on 08-11-2019,
satisfactory level of
GMP compliance.
90. M/s MTI Medical
(Pvt) Ltd, 586-587,
Sundar Industrial
Estate, Lahore
Hydroquine
200mg
Tablet
Each film coated tablet
contains:
Hydroxychloroquine
sulfate…….200mg
Dy.No. 6261
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Firm is granted GMP
certificate based on
inspection conducted
on 25-9-2019.
91. M/s Mass Pharma
(Pvt) Ltd., 17Km,
Ferozpur Road,
Lahore
H-Masquine
Tablet
200mg
Each film coated tablet
contains:
Hydroxychloroquine
sulfate…….200mg
Dy.No. 6259
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Inspection report
conducted on 04-09-
2018, firm has good
compliance of GMP.
92. M/s Friends pharma,
(pvt) ltd, 31-km
ferozepur road lahore.
Malaquine
tablet
200mg
Each Film Coated
Tablet contains:
Hydroxychloroquine
sulfate …… 200mg
Dy.No. 6386
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 08/03/2019, panel
recommended renewal
of DML.
93. M/s Uni-Tiech
Pharmaceuticals (Pvt)
Ltd. Plot#4/116,
Sector 21 Korangi
Industrial Area,
Karachi.
Hydroxychl
oroquine
200mg
tablet
Each Film Coated
Tablet contains:
Hydroxychloroquine
sulfate …… 200mg
Dy.No. 6464
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 08/10/2019
Satisfactory level of
GMP
94. M/s Fynk
Pharmaceuticals (Pvt)
Ltd. 19-km, GT Road
Kalashah Kaku,
Lahore.
Hydroquine
200mg
tablet
Each Film Coated
Tablet contains:
Hydroxychloroquine
sulfate …… 200mg
Dy.No. 6787
15/02/2019
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 21/11/2017, fair
level of GMP
compliance.
Decision: Registration Board approved registration of above applications from Serial No. 1 to 94.
Conditions regarding validity of registration and data requirement will be same as decided by the
Board in its general decision recorded above.
Minutes of 294th Meeting of Registration Board | 18
2. Chloroquine Phosphate 250mg Tablet:
Composition: Each Film Coated Tablet contains:
Chloroquine phosphate……..250mg
Reference Regulatory Authority status: Chloroquine phosphate (250mg & 500mg) film coated tablet by M/s Hima Pharma, USFDA
Approved.
While the product approved in MHRA is uncoated.
Generic status: 1. RESOCHIN 250MG TAB by M/s Bayer Karachi, Reg. No. 25
Specifications: USP Specification
Sr.
No.
Name of applicant Brand Name Composition Diary no. /
Date / fee /
Form
Pack
Size /
Price
Remarks/GMP status
95. M/s Ferozsons
Laboratories Ltd.
P.O Ferozsons,
Amangarh,
Nowshera-KPK
Chlroquine
Phosphate
250mg tablet
Each film coated tablet
contains:
Chloroquine
phosphate……..250mg
Dy.No. 5222
dated
24/03/2020
Rs. 20,000/-
Form 5
As per
SRO
Panel inspection dated
25-01-2019 concluded
that the panel
recommends grant of
GMP certificate.
96. M/s Metro
Pharmaceuticals,
Plot#14, St.#SS-2,
National Industrial
Zone, Rawat,
Islamabad.
M-Cloquin
tablet 250mg
Each film coated tablet
contains:
Chloroquine
phosphate……..250mg
Dy.No.5853
Dated
07/04/2020
Rs. 20,000/-
As per
SRO
The panel
recommended
renewal of DML,
inspection date
17/05/2019
97. M/s Genix pharma
Private Limited.
Geclo tablet
250mg
Each film coated tablet
contains:
Chloroquine
phosphate……..250mg
Dy.No. 5232
24/03/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 10/4/19,
acceptable level of
compliance GMP
guidelines.
98. M/s Briel
Pharmaceuticals
(Pvt) Ltd. 538-C,
Sundar Industrial
Estate Lahore.
B-quine
250mg tablet
Each film coated tablet
contains:
Chloroquine
phosphate……..250mg
Dy.No. 5929
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 24/05/2019, the
firm was found to be
operated at
satisfactory level of
GMP compliance.
99. M/s Glitz Pharma,
Plot# 265, Industrial
Triangle Kahuta
Road, Islamaad.
Chloroglit
tablet 250mg
Each film coated tablet
contains:
Chloroquine
phosphate……..250mg
Dy.No. 5297
26/03/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report,
16th Jan, 2019, the
panel recommended
issuance of GMP
certificate.
100. M/s Focus & Rules
Pharmaceuticasl (Pt)
Ltd. 44-Industrial
Triangle Kahuta
Road, Islamabad.
M-Quit
Tablet 250mg
Each film coated tablet
contains:
Chloroquine
phosphate……..250mg
Dy.No. 5293
26/03/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP certificate
issued on 18/03/2019.
101. M/s Bio-Mark
Pharmaceuticals,
Plot No. 527-Sundar
Industrial Estate,
Lahore.
Clokit 250mg
tablet
Each film coated tablet
contains:
Chloroquine
phosphate……..250mg
Dy.No. 5323
27/03/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm was GMP
compliant on the day
of inspection dated
13/02/2020
Minutes of 294th Meeting of Registration Board | 19
102. M/s Crystolite
Pharmaceuticals,
Plot#1&2, St.#S-2,
National Industrial
Zone, Rawat,
Islamabad.
Quinfex
250mg tablet
Each tablet contains:
Chloroquine
phosphate……..250mg
Dy.No. 5319
dated
27/03/2020
Rs. 20,000/-
Form 5
As per
SRO
DML renewed vide
letter No.F.1-54/09-
Lic (Vol-I) dated 6th
march 2019.
103. M/s Quaper (Pvt.)
Ltd. 26-A Samll
Industrial Estate
Lahore Road,
Sargodha.
Chloroquine
250mg tablet
Each tablet contains:
Chloroquine
phosphate……..250mg
Dy.No. 5884
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 28/1/19, panel
recommends renewal
of DML.
104. M/s Scotmann
Pharmaceuticasl, 5-
D, I-10/3, Industrial
Area, Islamabad.
Costat DS
Tablet 250mg
Each film coated tablet
contains:
Chloroquine
phosphate……..250mg
Dy.No. 5257
dated
30/03/2020
Rs. 20,000/-
Form 5
As per
SRO
Last Inspection report
dated 17-18/11/18,
panel recommended
regularization of
revised layout & grant
of renewal of license.
105. M/s Genetics
Pharmacetuicasl
(Pvt) Ltd, 539-A,
Sundar Industrial
Estate, Raiwind,
Lahore.
Coviquine
250mg tablet
Each film coated tablet
contains:
Chloroquine
phosphate……..250mg
Dy.No. 5365
dated
30/03/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 29/03/2019,
firm was operation at
satisfactory level of
GMP compliance.
106. M/s Genome
Pharmaceuticals Pvt.
Lt., Plot # 16/I-phase
IV, Industrial Estate
Hattar KPK,.
Genoquine
250mg tablet
Each film coated tablet
contains:
Chloroquine
phosphate……..250mg
Dy.No. 5420
01/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 03/05/2019.
Firm was operating
under good level
GMP.
107. M/s Nabiqasim
Industries (Pvt) Ltd.
17/24, Korangi
Industrial Area,
Karachi.
Miniquine
Tablet 250mg
Each film coated tablet
contains:
Chloroquine
phosphate……..250mg
Dy.No.5411
31/03/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP certificate
issued on 30th August,
2019.
108. M/s PharmEvo (Pvt)
Ltd, A-29, North
West Industrial Zone,
Light Industrial
Zone, Port Qasim,
Karachi.
Evoquin
250mg tablet
Each film coated tablet
contains:
Chloroquine phosphate ...
250mg
Dy. No.
5588 dated
06/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Panel inspection dated
07-02-02019
recommended
issuance of GMP
certificate
109. M/s Vision
Pharmaceuticals,
Plot#22-23,
Industrial Triangle,
Kahuta Road,
Islamabad
Visoquine
250mg tablet
Each film coated tablet
contains:
Chloroquine phosphate
….. 250mg
Dy. No.
5559 dated
06/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection dated
11-02-2019 concluded
good level of GMP
compliance.
110. M/s Invictus
Pharmaceuticals,
Plot No.21,26, NS2,
RCCI, Rawat,
Islamabad
Malaquin-P
250mg tablet
Each film coated tablet
contains:
Chloroquine phosphate
……..250mg
Dy.No. 5570
06/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Issuance of DML on
08-01-2019
111. M/s Global
Pharmaceuticals,
Plot No 204-205,
Kahuta Triangle,
C-Quin
250mg tablet
Each film coated tablet
contains:
Chloroquine phosphate
……..250mg
Dy.No. 5556
dated
06/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection dated
11 & 24-10-2018
recommended
issuance of GMP
certificate
Minutes of 294th Meeting of Registration Board | 20
Industrial Area,
Islamabad.
112. M/s Global
Pharmaceuticals,
Plot No 204-205,
Kahuta Triangle,
Industrial Area,
Islamabad.
C-Quin
250mg tablet
Each film coated tablet
contains:
Chloroquine phosphate
……..250mg
Dy.No. 5556
dated
06/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection dated
11 & 24-10-2018
recommended
issuance of GMP
certificate
113. M/s the Searle
company limited, F-
319 SITE Karachi,
Pakistan
Qoroza
250mg tablet
Each film coated tablet
contains:
chloroquine
phosphate……..250mg
Dy.No. 5577
Dated
06/04/2020
Rs. 20,000/-
As per
SRO
GMP certificate
issued on 22/07/2019.
114. M/s Zafa
Pharmaceuticals
Laboratories (Pvt)
Ltd., L1/B Block-22
Federal B Industrial
Area, Karachi.
Zafquin table
250mg
Each film coated tablet
contains:
chloroquine
phosphate……..250mg
Dy.No. 5530
Dated
06/04/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP certificate
issued on 05/09/2019.
115. M/s Cunningham
Pharmaceuticals
(Pvt) Ltd. Plot # 81
Sundar Industrial
Estate Raiwing Road,
Lahore.
Curine
250mg tablet
Each film coated tablet
contains:
chloroquine
phosphate……..250mg
Dy.No. 5544
06/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm has
maintained
conformance to GMP
compliance as per
inspection report
dated 01/04/2019.
116. M/s Wimits
Pharmaceuticals
(Pvt) Ltd. Plot#129,
Sundar Industrial
Estate (PIE) Raiwind
Road, Lahore.
Covlor-P
250mg tablet
Each film coated tablet
contains:
chloroquine
phosphate……..250mg
Dy.No. 5541
Dated
06/04/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP Certificate
issued on 10-12-2018.
117. M/s Aims
Pharmaceuticals,
Plot#291, Industrial
Triangle Kahuta
Road, Islamabad.
H0chlor
tablet 250mg
Each film coated tablet
contains:
chloroquine
phosphate……..250mg
Dy.No. 5532
Dated
06/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Panel recommended
renewal of DML,
dated 31/05/2018.
118. M/s MartinDow
Limited, Plot no. 37,
sector 19, Korangi
Industrial Area
Karachi.
Clordow
Tablet 250mg
Each film coated tablet
contains:
chloroquine
phosphate……..250mg
Dy.No. 5534
Dated
06/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm was
operating at good
level of compliance
with GMP as per
inspection report
dated 06/12/2018.
119. M/s Reko Pharmacal
Pvt. Limited, 13km,
Multan road Lahore.
Requine
tablet 250mg
Each film coated tablet
contains:
chloroquine
phosphate……..250mg
Dy.No. 5528
Dated
06/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The panel
recommended
renewal of DML
except Liquid
injectable section on
the basis of inspection
dated 02/05/2017.
120. M/s MartinDow
Marker Ltd.
(formerly Meck (pvt)
ltd) 7, jail road
Quetta.
Covoquin
tablet 250mg
Each film coated tablet
contains:
chloroquine
phosphate……..250mg
Dy.No. 5777
Dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm’s GMP
compliance level is
rated as good as per
the inspection report
dated 12/07/2019.
Minutes of 294th Meeting of Registration Board | 21
121. M/s Medpharm
research Lab, 28 km
ferozpur road
Lahore.
Medochin
tablet 250mg
Each Film Coated Tablet
contains:
Chloroquine
phosphate……..250mg
Dy.No.6180
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
DML issued on
26/02/2018.
122. M/s Masfa Industries
17km, Sheikhupura
Road, Lahore.
Masfaquine
250mg tablet
Each Film Coated Tablet
contains:
Chloroquine
phosphate……..250mg
Dy.No.6172
08/04/2020
Rs. 20,000/-
(20,000×2)
Form 5
As per
SRO
Last inspection report
dated 29/03/2019,
good level of GMP
compliance
123. M/s Standpharm
Pakistan (pvt) Ltd.
Lahore.
Coren Tablet
250mg
Each Film Coated Tablet
contains:
Chloroquine
phosphate……..250mg
Dy.No. 6197
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP inspection
was conducted on 19-
10-2017 & the report
concludes a
satisfactory level of
GMP compliance.
124. M/s Hygeia
Pharmaceuticals
Industrial Triangles
Kahuta Road
Islamabad.
H-Quin
250mg tablet
Each Film Coated Tablet
contains:
Chloroquine
phosphate……..250mg
Dy.No. 5863
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
21/09/2017,
satisfactory level of
GMP compliance.
125. M/s Aurik
Pharmaceuticals,
Plot # 6&7, St #S-9
National Industrial
Zone, Rawat
Islamabad.
Coronil
250mg tablet
Each Film Coated Tablet
contains:
Chloroquine
phosphate……..250mg
Dy.No. 5794
dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 05/9/18, the firm
was complying with
GMP standards.
126. M/s Fresh
Pharmaceutical, Plot
No. 07, Street No. S-
6, National Industrial
Zone, RCCI, Rawat,
Rawalpindi.
Chloro
250mg tablet
Each film coated tablet
contains:
Chloroquine
phosphate……..250mg
Dy. No.
5908 dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection dated
02-10-2019
complying
satisfactory level
cGMP.
127. M/s Pharmasol (Pvt)
Ltd. Plot#549,
Sundar Industrial
Estate, Raiwind
Road, Lahore.
Quinovid
250mg tablet
Each film coated tablet
contains:
Chloroquine
phosphate……..250mg
Dy.No. 6130
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection dated
08-07-2019 & 25-07-
2019 concluding
satisfactory level
GMP compliance.
128. M/s Albro Pharma
Private Limited.
340-S Industrial
state, Kot Lakhpat,
Lahore.
Malabro
250mg tablet
Each film coated tablet
contains:
Chloroquine
phosphate……..250mg
Dy. No.
6234 dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP dated 30-
05-2019 concluding
that firm is complying
most of the GMP
guidelines
129. M/s Sami
Pharmaceuticals, S-
95, SITE, Karachi.
Samochin
250mg tablet
Each film coated tablet
contains:
Chloroquine phosphate
…….. 250mg
Dy.No.6167
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP certificate
issued on 14-06-2018.
130. M/s Macter
International
Limited, F-216,
S.I.T.E, Karachi
Macvid
250mg tablet
Each film coated tablet
contains:
Chloroquine phosphate
…….. 250mg
Dy.No. 6128
dated
07/04/2020
Rs. 20,000/-
Form 5
30’s,
price
Rs.
11.50/-
per
tablet
Inspection conducted
on 23-01-2019
concludes the firm is
considered to be
operating at good
level of GMP.
Minutes of 294th Meeting of Registration Board | 22
131. M/s Winlet
Pharmaceuticals, 30-
km, Lahore Sargodha
Road, Lahore
Winquin
250mg Tablet
Each film coated tablet
contains:
Chloroquine phosphate
…….. 250mg
Dy.No. 6128
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm is granted
New DML based on
inspection dated 05-
12-2017.
132. M/s. Sayyed
Pharmaceutical
Industries (Pvt) Ltd.,
Plot#67/2, Phase-3,
Industrial Estate,
Hattar
Chlorsyd
250mg tablet
Each film coated tablet
contains:
Chloroquine phosphate
…….. 250mg
Dy.No. 5797
dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Inspection conducted
on 04-09-2019 the
firm operates at
satisfactory level of
GMP guidelines.
133. M/s HIMARK
Laboratories (Pvt.)
Ltd., Plot#37-A,
Sundar Industrial
Estate, Lahore
Marquin-CP
250mg tablet
Each film coated tablet
contains:
Chloroquine phosphate
…….. 250mg
Dy.No.5782
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
New License
134. M/s Linta
Pharmaceutical (Pvt)
Ltd. Plot # 03, St# S-
5, Rawat Industrial
Estate, Islamabad
Lintque
250mg tablet
Each film coated tablet
contains:
Chloroquine phosphate
…….. 250mg
Dy.No.5870
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP inspection was
conducted on 12-06-
18 and the report
concludes the firm to
be GMP complaint.
135. M/s Gray’s
Pharmaceutical, Plot
# 2, Street No N-3,
national industrial
Zone, Rawat
Grayquin
250mg tablet
Each film coated tablet
contains:
Chloroquine phosphate
…….. 250mg
Dy.No.5865
dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Inspection conducted
on 23-05-2019 overall
GMP compliance
graded as Good.
136. M/s Pulse
Pharmaceutical (Pvt)
Ltd. Raiwind Road
Lahore.
Queenchlor
250mg Tablet
Each tablet contains:
Chloroquine
phosphate…..250mg
Dy.No. 6125
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Certificate of cGMP is
issued to the firm
based on evaluation
conducted on 10th
May, 2017
137. M/s Searle IV
Solutions (Pvt) Ltd.
1.5km, Manga
Raiwind Road,
Lahore
Macquine
250mg Tablet
Each tablet contains:
Chloroquine
phosphate…..250mg
Dy.No. 6134
24/03/2020
Rs. 20,000/-
Form 5
As per
SRO
27-02-2018. GMP
Certificate issued on
15-03-2018.
138. M/s Saibins
Pharmaceuticals,
Plot#316, Industrial
Triangle, Kahuta
Road, Islamabad
Quine Tablets Each tablet contains:
Chloroquine
phosphate…..250mg
Dy.No. 6143
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP certificate
issued on 17/1/2019
on the basis of
inspection conducted
on 24/12/2018.
139. M/S Indus Pharma
(Pvt) Ltd, Plot No.
26, 27,63, 64, 65, 66
& 67, Sector-27,
Korangi Industrial
Area, Karachi.
Indoquine-P
250mg Tablet
Each tablet contains:
Chloroquine
phosphate…..250mg
Dy.No. 6145
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection was
conducted on 16-8-17
& report concludes
that firm was
considered to be
operating at an
acceptable level of
GMP compliance
140. M/s Wnsfeild
Pharmaceuticals,
Plot No. 122, Phase
V,
Block A, Industrial
Estate Hatter, KPK
Chlorwin
250mg Tablet
Each tablet contains:
Chloroquine
phosphate…..250mg
Dy.No. 6285
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Panel inspection dated
18-01-2018
unanimously
recommends renewal
of DML No. 000610
by way of formulation
Minutes of 294th Meeting of Registration Board | 23
141. M/s Wenovo
Pharmaceuticals
Plot#31 & 32, Punjab
Small Industrial
Estate Taxila
Pakistan
Kalqin
250mg Tablet
Each tablet contains:
Chloroquine
phosphate…..250mg
Dy.No. 6289
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP inspection
conducted on 30-09-
2018 & 29-10-2018
and report concludes
that Firm is compliant
to current GMP
142. M/s Saaf
Pharmaceuticals,
Plot#15, Special
Industrial Zone,
Risalpur, KPK
F-Quin
250mg Tablet
Each Film Coated Tablet
contains:
Chloroquine
phosphate……..250mg
Dy.No. 6266
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Inspection report
dated 20-2-2019, the
panel recommended
the resumption of
production.
143. M/s Medera
Pharmaceuticals Pvt
Ltd, Plot#2, St.#4,
National Industrial
Zone, Rawat,
Islamabad
Queen 250mg
Tablet
Each Film Coated Tablet
contains:
Chloroquine
phosphate……..250mg
Dy.No. 6227
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP inspection
conducted on 07-11-
2018 & report
concludes that overall
GMP compliance is
found Good of today.
144. M/s Amros
Pharmaceuticals, A-
96, S.I.T.E. Super
Highway, Karachi.
Amro Quine
250mg Tablet
Each Film Coated Tablet
contains:
Chloroquine
phosphate……..250mg
Dy.No. 6249
dated
08/04/2020
Rs. 20,000/-
Form 5
Last inspection report
dated 18/7/18
confirms the current
compliance level as
Good.
145. M/s Allmed Pvt Ltd.
Plot No. 590, Sundar
Industrial Estate,
Lahore, Pakistan
Chlorogen
Tablet 250mg
Each film coated tablet
contains:
Chloroquine phosphate
…….. 250mg
Dy. No. 6236
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP inspection
conducted on 01-01-
2020 and report
concludes GMP
compliance.
146. M/s MTI Medical
(Pvt) Ltd, 586-587,
Sundar Industrial
Estate, Lahore
Qonine
250mg
Tablet
Each tablet contains:
Chloroquine
phosphate…….250mg
Form 5
Dy.No. 6262
08/04/2020
Rs. 20,000/-,
Form 5
As per
SRO
The firm is granted
GMP certificate based
on inspection
conducted on 25-9-
2019.
147. M/s Mass Pharma
(Pvt) Ltd., 17Km,
Ferozpur Road,
Lahore
MASOQUI
NE Tablet
250mg
Each tablet contains:
Chloroquine
phosphate……..250mg
Form 5
Dy.No. 6258
08/04/2020
Rs. 20,000/-,
Form 5
As per
SRO
Inspection report
conducted on 04-9-
2018, the firm has
good compliance of
GMP.
Decision: Registration Board approved registration of above applications from Serial No. 95 to
147. Conditions regarding validity of registration and data requirement will be same as decided
by the Board in its general decision recorded above.
Minutes of 294th Meeting of Registration Board | 24
3. Chloroquine Phosphate 500mg Tablet: Composition:
Each Film Coated Tablet contains:
Chloroquine phosphate……..500mg
Reference Regulatory Authority status:
Chloroquine phosphate (250mg & 500mg) film coated tablet by M/s Hima Pharma, USFDA
Approved.
While the product approved in MHRA is uncoated.
Generic status: not registered
Specifications: USP Specification
Sr.
No.
Name of applicant Brand
Name
Composition Diary no. /
Date / fee /
Form
Pack
Size /
Price
Remarks/GMP
status
148. M/s Genix pharma
Private Limited.
Geclo tablet
500mg
Each film coated tablet
contains:
Chloroquine
phosphate…….500mg
Dy.No.5233
24/03/2020
Rs. 20,000/-
Rs. 30,000/-
07/04/2020
Form 5D
As per
SRO
Last inspection report
dated 10/04/2019,
acceptable level of
compliance GMP
guidelines.
149. M/s Scotmann
Pharmaceuticasl, 5-D,
I-10/3, Industrial
Area, Islamabad.
Costat DS
Tablet
500mg
Each film coated tablet
contains:
Chloroquine
phosphate…..500mg
Dy.No. 5258
dated
30/03/2020
Rs. 50,000/-
Form 5D
As per
SRO
Last Inspection report
dated 17-18/11/2018,
panel recommended
regularization of
revised layout and
grant of renewal of
license.
150. M/s Genetics
Pharmacetuicasl pvt
limited, 539-A,
Sundar Industrial
Estate, Raiwind,
Lahore.
Coviquine
500mg
tablet
Each film coated tablet
contains:
Chloroquine
phosphate…….500mg
Dy.No. 5364
dated
30/03/2020
Rs. 20,000/-
Rs. 30,000/-
17/04/2020
Form 5D
As per
SRO
Last inspection report
dated 29/03/2019,
firm was operation at
satisfactory level of
GMP compliance
151. M/s MartinDow
Marker Ltd. (formerly
Meck (Pvt) Ltd) 7, jail
road Quetta.
Covoquin
tablet
500mg
Each film coated tablet
contains:
Chloroquine
phosphate……..500mg
Dy.No. 5778
Dated
07/04/2020
Rs. 50,000/-
Form 5D
As per
SRO
The firm’s GMP
compliance level is
rated as good as per
the inspection report
dated 12/07/2019.
Decision: Registration Board approved registration of above applications from S No. 148 to 151.
Conditions regarding validity of registration and data requirement will be same as decided by
Board in its general decision
Minutes of 294th Meeting of Registration Board | 25
4. Chloroquine Phosphate Syrup: Composition: Each 5ml contains:
Chloroquine Phosphate eq. to Chloroquine …… 50mg
Reference Regulatory Authority status:
Malarivon Syrup 50mg /5ml approved by MHRA of UK
Generic status: Malaquin syrup of M/s Rakaposhi Pharmaceutical Ltd., Peshawar having registration no. 034687
Specifications: USP Specification
Sr.
No.
Name of applicant Brand Name composition Diary no. /
Date / fee /
Form
Pack
Size /
Price
Remarks/GMP status
152. M/s Metro
Pharmaceuticals Plot#
14, St.No. SS-2,
National Industrial
Zone, Rawat,
Islamabad.
M-Cloquin
syrup
50mg/5ml
Each 5ml contains:
Chloroquine phosphate
eq. Chloroquine..50mg
Dy. No. 5852
Dated
07/04/2020
Rs. 20,000/-
As per
SRO
The panel
recommended renewal
of DML, inspection
date 17/05/2019
153. M/s Global
Pharmaceuticals, Plot
No 204-205, Kahuta
Triangle, Industrial
Area, Islamabad.
C-Quin
50mg/5ml
Syrup
Each 5ml contains:
Chloroquine phosphate
eq. Chloroquine …...
50mg
Dy. No. 5554
06-04-2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection dated
11 & 24-10-2018
recommended issuance
of GMP certificate
154. M/s Glitz Pharma, plot
No. 265, industrial
triangle Kahuta Road
Islamabad.
Chloroglit
syrup
50mg/5ml
Each 5ml contains:
Chloroquine phosphate
eq. Chloroquine ......
50mg
Dy. No. 5296
06-04-2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report,
16th jan, 2019, the
panel recommended
issuance of GMP
certificate.
155. M/s Focus & Rules
Pharmaceuticasl (pvt)
Ltd. 44-industrial
triangle kahuta road,
Islamabad.
M-Quit
syrup
50mg/5ml
Each 5ml contains:
Chloroquine phosphate
eq. Chloroquine ......
50mg
Dy. No. 5292
06-04-2020
Rs. 20,000/-
Form 5
As per
SRO
GMP certificate issued
on 18/03/2019.
156. M/s Care
Pharmaceuticals, 8 Km,
Thokar Raiwind Road,
Lahore
Carequin
Oral
Suspension
50mg/5ml
Each 5ml contains:
Chloroquine phosphate
eq. Chloroquine …...
50mg
Dy. No. 5801
07-04-2020
Rs. 20,000/-
Form 5
As per
SRO
The firm was granted
GMP certificate based
on inspection
conducted on 13-03-
2019.
157. M/s HIMARK
Laboratories Pvt. Ltd.,
Plot # 37-A, Sundar
Industrial Estate,
Lahore
Marquin- CP
50mg/5ml
Each 5ml contains:
Chloroquine phosphate
eq. Chloroquine …...
50mg
Dy. No. 5781
07-04-2020
Rs. 20,000/-
Form 5
As per
SRO
New license
158. Saaaf Pharmaceuticals,
plot No. 15, Special
Industrial Zone,
Risalpur, KPK
F-Quin
Syrup
50mg/5ml
Each 5ml contains:
Chloroquine Phosphate
eq. to Chloroquine
…… 50mg
Dy.No. 6267
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Inspection report dated
20-2-2019, the panel
recommended the
resumption of
production.
159. M/s Amros
Pharmaceuticals, A-96,
S.I.T.E. Super
Highway, Karachi.
Amro Quine
Syrup
50mg/5ml
Each 5ml contains:
Chloroquine Phosphate
eq. to Chloroquine
…… 50mg
Dy.No. 6248
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 18/07/2018
confirms current
compliance level as
Good.
Minutes of 294th Meeting of Registration Board | 26
160. M/s Allmed Pvt Ltd.
Plot No. 590, Sundar
Industrial Estate,
Lahore, Pakistan
Chlorogen
Syrup
50mg/5ml
Syrup
Each 5ml contains:
Chloroquine
phosphate eq.
Chloroquine….50mg
Dy. No. 6237
06-04-2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP inspection
conducted on 01-1-
2020 & report
concludes GMP
compliance.
Decision: Registration Board approved registration of above applications from Serial No. 142 to
160. Conditions regarding validity of registration and data requirement will be same as decided by
the Board in its general decision recorded above.
5. Lopinavir/Ritonavir (200mg/50mg) Tablet:
Composition: Each film Coated Tablet contains:
Lopinavir……..200mg
Ritonavir……..50mg
Reference Regulatory Authority status:
Kaletra (200mg/50mg & 100mg/25mg) Film coated tablet by M/s Abbvie, USFDA Approved.
Generic Status: 1. Lopinavir/Ritonavir Tablets 200mg/50mg by M/S Scitech Health (Private)
Limited, Reg. No. 62250
Specifications: USP Specification
Sr.
No.
Name of applicant Brand Name composition Diary no. /
Date / fee /
Form
Pack
Size /
Price
Remarks
161. M/s Martin Dow
Limited, Plot No.37,
Sector 19, Korangi
Industrial Area
Karachi.
Ritolop tablet
200mg/50mg
Each film coated tablet
contains:
Lopinavir…200mg
Ritonavir…50mg
Dy. No. 5861
Dated
07/04/2020
Rs. 20,000/-
As per
SRO
The firm was operating
at good level of
compliance with GMP
as per inspection report
dated 06/12/2018.
162. M/s Aulton
Phamraceutical, plot
# 84/1, Block A,
Phase V, Industrial
Estate Hattar.
Kalaulta
200mg/50mg
tablets
Each film coated tablet
contains:
Lopinavir…200mg
Ritonavir…50mg
Dy. No. 5945
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm was last
inspected on
13.02.2018, the firm
was operating at good
level of compliance
with cGMP guidelines
163. M/s Seraph
Pharmaceuticals,
Plot#210, Industrial
Triangle, Kahuta
Road, Islamabad.
NT-Cor tablet
200mg/50mg
Each film coated tablet
contains:
Lopinavir…200mg
Ritonavir…50mg
Dy.No. 5282
dated
25/03/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP certificate issued
on the basis of
inspection conducted
on 11/07/2019
164. M/s Genix pharma
Private Limited.
Loprit Tablet
200mg/50mg
Each film coated tablet
contains:
Lopinavir……200mg
Ritonavir……50mg
Dy.No. 5524
03/04 /2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 10/4/19,
acceptable level of
compliance GMP
guidelines.
165. M/s Bio-Mark
Pharmaceuticals, Plot
No.527-Sundar
Industrial Estate,
Lahore.
Ritopin tablet
200mg/50mg
Each film coated tablet
contains:
Lopinavir……200mg
Ritonavir……50mg
Dy.No. 5324
27/03/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm was GMP
compliant on the day of
inspection dated
13/02/2020.
166. M/s Genome
Pharmaceuticals Pvt.
Lt., Plot # 16/I-phase
IV, Industrial Estate
Hattar KpK,.
Lopirit
200mg/50mg
tablet
Each film coated tablet
contains:
Lopinavir……200mg
Ritonavir……50mg
Dy.No. 5419
dated
01/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 03/05/2019. Firm
was operating under
good level GMP.
Minutes of 294th Meeting of Registration Board | 27
167. M/s Crystolite
Pharmaceuticals,
Plot#1&2, St.S-2,
National Industrial
Zone, Rawat,
Islamabad.
Loretra
Tablet
200mg/50mg
Each film coated tablet
contains:
Lopinavir……200mg
Ritonavir……50mg
Dy.No. 5414
dated
27/03/2020
Rs. 20,000/-
Form 5
As per
SRO
DML renewed vide
letter No.F.1-54/2009-
Lic (Vol-I) dated 6th
March 2019.
168. M/s Sapient Pharma,
123-S Industrial Area
, Kot Lakhpat, Lahore
Pinrit Tablet
200mg/50mg
Each film coated tablet
contains:
Lopinavir……200mg
Ritonavir……50mg
Dy. No. 5787
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Panel inspection dated
19-9-2019 & 18-11-
2019 recommended
renewal of DML.
169. M/s Wimits
Pharmaceuticals(Pvt)
Ltd. Plot No. 129,
Sundar Industrial
Estate (PIE) Raiwind
Road Lahore.
Lorit
200mg/50mg
tablet
Each film coated tablet
contains:
Lopinavir……200mg
Ritonavir……50mg
Dy. No. 5539
Dated
06/04/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP Certificate issued
on 10-12-2018.
170. M/s MartinDow
Marker Ltd.
(formerly Meck (Pvt)
ltd) 7, Jail Road
Quetta.
Covolor
Tablet
200mg/50mg
Each film coated tablet
contains:
Lopinavir……200mg
Ritonavir……50mg
Dy. No. 5776
Dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm’s GMP
compliance level is
rated as good as per
inspection report dated
12/07/2019.
171. M/s Quaper pvt. Ltd.
26-A Samll industrial
estate Lahore road
Sargodha.
Qlatra tablet
200mg/50mg
Each film coated tablet
contains:
Lopinavir……200mg
Ritonavir……50mg
Dy.No. 5888
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 28/1/2019, the
panel recommends the
renewal of DML.
172. M/s the Searle
Company Limited, F-
319, S.I.T.E.,
Karachi.
Ritohi tablet
200mg/50mg
Each film Coated Tablet
contains:
Lopinavir……..200mg
Ritonavir……..50mg
Dy. No. 5800
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP certificate issued
on 22/07/2019.
173. M/s Next
Pharmaceutical
Products (Pvt) Ltd.,
Plot No. 44 A-B,
Sundar Industrial
Estate, Lahore.
Loritanext
200mg/50mg
tablet
Each film Coated Tablet
contains:
Lopinavir……..200mg
Ritonavir……..50mg
Dy.No. 6156
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP certificate issued
on 08/07/2019.
174. M/s Glitz Pharma,
Plot No 265,
Industrial Triangle,
Kahuta Road,
Islamabad.
Loprit tablet Each film coated tablet
contains:
Lopinavir……200mg
Ritonavir……50mg
Dy.No. 5879
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Issuance of GMP
certificate dated 16-01-
2019
175. M/s Tabros Pharma
(Pvt.) Ltd Plot No.L-
20/B, Karachi
Industrial Area,
Sector-22, Federal B
Area, Karachi.
Rotana tablet
200/50
Each film coated tablet
contains:
Lopinavir……200mg
Ritonavir……50mg
Dy. No. 5893
dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP inspection
conducted on 07/02/18
& report
concludes on the basis
of current inspection it
was observed that firm
rectified all
observations noted
during last GMP
Inspection.
176. M/s EG
Pharmaceutical,
Industrial Triangle
KR, Islamabad.
Loritivar
tablet 200/50
Each film coated tablet
contains:
Lopinavir……200mg
Ritonavir……50mg
Dy. No. 5926
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Renewal of DML
recommended in the
inspection dated 13-02-
2019.
Minutes of 294th Meeting of Registration Board | 28
177. M/s. Athan
Pharmaceuticals
Plot#84/1, Block B,
Phase V industrial
Estate, Hattar
Kalath tablet
200/50
Each film coated tablet
contains:
Lopinavir……200mg
Ritonavir……50mg
Dy. No. 5951
dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
New DML issued on 5-
03-2019.
178. M/s Albro Pharma
Private Limited.
340-S Industrial state,
Kot Lakhpat, Lahore,
Pakistan
Albetra tablet
200/50
Each film coated tablet
contains:
Lopinavir……200mg
Ritonavir……50mg
Dy.No.6232
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP dated 30-
05-2019 concluding
that firm is complying
most of the GMP
guidelines
179. M/s Linear Pharma,
Plot No. 18, S. No. S-
4, National Industrial
Zone, RCCI, Rawat,
Islamabad.
Lipivir tablet
200/50
Each film coated tablet
contains:
Lopinavir …… 200mg
Ritonavir …… 50mg
Dy.No.6183
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP dated 30-01-
2019 concluding that
firm is operating at
satisfactory level of
compliance with GMP
standards
180. M/s Pharmix Lab. 21-
Km Ferozepur Road,
Lahore.
Lipivir tablet
200/50
Each film coated tablet
contains:
Lopinavir …… 200mg
Ritonavir …… 50mg
Dy.No.6221
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 13/09/2019,
panel recommended
renewal of DML.
181. M/s Shrooq
Pharmaceuticals Pvt.
Ltd, 21-Km,
Ferozepur Road, Near
Masjid Ibrahim,
Lahore.
Lipivir tablet
200/50
Each film coated tablet
contains:
Lopinavir …… 200mg
Ritonavir …… 50mg
Dy.No.6196
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 07-06-2017 &
30-08-2017
recommended renewal
of DML.
182. M/s Horizon Health
Care Pvt Ltd, Plot 35
A, Small Industrial
Estate, Taxila.
Lopira tablet
200/50
Each film coated tablet
contains:
Lopinavir …… 200mg
Ritonavir …… 50mg
Dy.No.6176
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP inspection
was conducted on 25-
06-2018 and the report
concludes that
company has shown
good response and
rectified the problems
and has shown good
compliance as per
schedule B-II.
183. M/s Macter
International Limited,
F-216, S.I.T.E,
Karachi.
Macletra
tablet
200mg/50mg
Each film coated tablet
contains:
Lopinavir……200mg
Ritonavir……50mg
Dy.No.5904
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Inspection conducted
on 23-01-2019
concludes the firm is
considered to be
operating at good level
of GMP.
184. M/s Fresh
Pharmaceuticals,
Plot#07, Street S-6
National Industrial
Zone Rawat,
Islamabad
Lopirivirt
tablet
200mg/50mg
Each film coated tablet
contains:
Lopinavir……200mg
Ritonavir……50mg
Dy.No.5906
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP inspection report
dated 02-10-2019 is
complying satisfactory
level of cGMP as of
today.
185. M/s Hamaz
Pharmaceuticals
(Pvt.) Ltd. 13-Km,
Bosan Road,
Lutfabad, Multan
NOVAPIR
tablet
200mg/50mg
Each film coated tablet
contains:
Lopinavir……200mg
Ritonavir……50mg
Dy.No.5918
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm is granted
GMP certificate based
on inspection
conducted on 28-09-
2019.
Minutes of 294th Meeting of Registration Board | 29
186. M/s CCL
Pharmaceuticals
(Pvt.) Ltd., 62-
Industrial Estate, Kot
Lakhpat, Lahore
Corovir
tablet
200mg/50mg
Each film coated tablet
contains:
Lopinavir……200mg
Ritonavir……50mg
Dy.No.
5938 dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm was granted
GMP certificate based
on inspection dated 24-
04-2018.
187. M/s PharmEvo (Pvt).
Limited Plot # A-29,
North Western
Industrial Zone Port
Qasim Karachi
EVOKAL
Tablet
200mg/50mg
Each film coated tablet
contains:
Lopinavir……200mg
Ritonavir……50mg
Dy.No. 5871
dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP inspection dated
23-02-2018 the firm
was operating at an
acceptable level of
compliance with GMP
standards.
188. M/s Wnsfeild
Pharmaceuticals, Plot
No. 122, Phase V,
Block A, Industrial
Estate Hatter, KPK
Letnova
200/50mg
Tablet
Each film Coated
Tablet contains:
Lopinavir……..200mg
Ritonavir……..50mg
Dy.No. 6286
dated
08/04/2020
Rs. 50,000/-
Form 5
As per
SRO
Panel inspection dated
18-1-2018
unanimously
recommends the
renewal of DML no.
000610 by way of
formulation.
189. M/s Wenovo
Pharmaceuticals
Plot # 31& 32 Punjab
Small Industrial
Estate Taxila
Pakistan
Lopirit
200/50mg
Tablet
Each film Coated Tablet
contains:
Lopinavir……..200mg
Ritonavir……..50mg
Dy.No. 6294
dated
08/04/2020
Rs. 50,000/-
Form 5
As per
SRO
Last GMP inspection
conducted on 30-09-
2018 & 29-10-2018
and report concludes
that Firm is compliant
to current GMP
190. M/s Polyfine
Chempharma.
51-Industrial Estate,
Hayatabad,
Peshawar, Pakistan
Petala
200/50mg
Tablet
Each film Coated Tablet
contains:
Lopinavir……..200mg
Ritonavir……..50mg
Dy.No. 6297
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP inspection
conducted on 07-02-
2018 & report
concludes that Based
on the area inspected
the people met &
document reviewed &
considering findings of
inspection firm was
considered to be
operated at acceptable
level of compliance
with GMP guideline.
191. M/s Sami
Pharmaceuticals, S-
95, SITE, Karachi.
Opna tablet
200/50
Each film coated tablet
contains:
Lopinavir …… 200mg
Ritonavir …… 50mg
Dy. No. 6253
08/04/2020
Rs. 20,000/-,
Rs. 30,000/-
Form 5D
As per
SRO
GMP certificate issued
on 14-6-2018.
192. M/s Allmed Pvt Ltd.
Plot No. 590, Sundar
Industrial Estate,
Lahore.
Lorita tablet
200/50
Each film coated tablet
contains:
Lopinavir …… 200mg
Ritonavir …… 50mg
Dy. No. 6241
08/04/2020
Rs. 50,000/-
Form 5D
As per
SRO
Last GMP inspection
conducted on 1-1-20 &
report concludes GMP
compliance.
193. M/s Welwrd
Pharmaceuticals, Plot
#03, Block A, PhaseI-
II,Industrial Estate,
Hattar
RITLOP
200/50 mg
tablet
Each film coated tablet
contains:
Lopinavir……200mg
Ritonavir……50mg
Dy.No. 6282
dated
08/04/2020
Rs. 50,000/-
Form 5
As per
SRO
Inspection conducted
on 12-11-2018 the firm
is operating at
satisfactory level of
GMP.
194. M/s MTI Medical
(Pvt) Ltd, 586-587,
Sundar Industrial
Estate, Lahore
Lopivir
200/50 mg
tablet
Each film coated tablet
contains:
Lopinavir……200mg
Ritonavir……50mg
Dy.No. 6260
08/04/2020
Rs. 50,000/-
Form 5D
As per
SRO
Firm is granted GMP
certificate based on
inspection conducted
on 25-9-2019.
Minutes of 294th Meeting of Registration Board | 30
195. M/s English
Pharmaceutical
Industries, Link
Kattar Bund Road
Thokar Niaz Baig
Multan Road, Lahore
Loretra
200mg/50m
g tablet
Each film Coated Tablet
contains:
Lopinavir…..200mg
Ritonavir……..50mg
Dy.No. 6477
dated
09/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
date 17& 18/01/2019,
fair compliance
196. M/s Briel
Pharmaceuticals (Pvt)
Ltd. 538-C, Sundar
Industrial Estate
Lahore.
Bellet
200mg/50m
g tablet
Each film Coated Tablet
contains:
Lopinavir…..200mg
Ritonavir……..50mg
Dy. No. 5931
dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 24/5/19, the firm
was found to be
operated at satisfactory
level of GMP
compliance.
Decision: Registration Board approved registration of above applications from Serial No. 161 to 195.
Conditions regarding validity of registration and data requirement will be same as decided by the Board in
its general decision recorded above.
Minutes of 294th Meeting of Registration Board | 31
Import:
197. Name and address of Applicant M/s AGP LimitedB-23, S.I.T.E., Karachi-75700, Pakistan.
Detail of Drug Sale License Address: AGP Limited, B-23-C, S.I.T.E, Karachi.
Validity: 21 September, 2021
Status: Valid
Name and address of manufacturer M/s Mylan Laboratories Limited, F-4 & F-12, MIDC, Malegaon,
TAL, Sinnar, Nashik 422113 Maharashtra State, India.
Name and address of marketing
authorization holder
M/s Mylan Laboratories Limited, F-4 & F-12, MIDC, Malegaon,
TAL, Sinnar, Nashik 422113 Maharashtra State, India.
Name of exporting country India
Type of Form Form 5-F
Diary No. & Date of R& I Dy. No. 5527 Dated 06-10-2018
Fee including differential fee Rs. 100,000/- Dated 05-10-2018
Brand Name+Dosage Form+Strength Lopinavir/Ritonavir Tablets 200mg/50mg
Composition Each film coated tablet contains:
Lopinavir……200mg
Ritonavir……50mg
Finished Product Specification USP
Pharmacological Group Anti viral
Shelf life 24 months
Demanded Price As per SRO
Pack size HDPE bottle of 120tablets
Me too Lopinavir/Ritonavir Tablets 200mg/50mg By M/S Scitech Health
(Private) LIMITED, Rweg No. 62250
Detail of certificates attached Copy of CoPP:
Certificate No:
COPP/CERT/NKD/74692/2018/11/24108/125666
Certifying Authority: Food & Drug Administration M.S
Valid upto: 12th June, 2021
Free sale in exporting country: Yes
Applicant of certificate:
GMP: Facilities and operation conform to WHO GMP as per
COPP
Applicant of certificate: M/s Mylan Laboratories Limited, F-4
& F-12, MIDC, Malegaon, TAL., Sinnar, Nashik 422113
Maharashtra State, India.
1. The manufacturer complies with the principles and guidelines
of GMP as per the certificate of GMP (EudraGMDP).
Remarks of the Evaluator:
Decision: Registration Board approved registration of above application as per Policy of inspections
of manufacturer abroad. As application was made on Form 5-F along with the product development
and stability studies data hence validity of registration shall be 5 years. Firm shall provide legalized
version of CoPP in 3 months time.
Minutes of 294th Meeting of Registration Board | 32
6. Lopinavir/Ritonavir Oral Solution: Composition: Each ml contains:
Lopinavir……..80mg
Ritonavir……..20mg
Reference Regulatory Authority status:
Kaletra Oral Solution 80mg/20mg by M/s Abbvie, USFDA Approved.
Me too: Kaletra Oral Solution 80mg/20mg By M/S Abbott, Reg. No. 28427
Specifications: USP Specification Sr.
No.
Name of applicant Brand Name composition Diary no. /
Date / fee /
Form
Pack
Size /
Price
Remarks/GMP status
198. M/s Bio-Mark
Pharmaceuticals,
plot No. 527-sundar
industrial estate,
Lahore.
Ritopin Oral
Solution
80mg/20mg
Each ml contains:
Lopinavir……..80mg
Ritonavir……..20mg
Dy. No. 5325
dated
27/03/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm was GMP
compliant on the day of
inspection dated
13/02/2020
199. M/s Sapient
Pharma, 123-S
Industrial Area, Kot
Lakhpat, Lahore.
Pinrit Oral
Solution
80mg/20mg
Each ml contains:
Lopinavir……..80mg
Ritonavir……..20mg
Dy. No. 5786
dated
27/03/2020
Rs. 20,000/-
Form 5
As per
SRO
Panel inspection dated
19-9-2019 & 18-11-2019
recommended renewal of
DML.
200. M/s Pharmix Lab.
21-Km Ferozepur
Road, Lahore.
Lopnit Oral
Solution
80mg/20mg
Each ml contains:
Lopinavir……..80mg
Ritonavir……..20mg
Dy. No. 6220
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 13/09/2019,
The panel recommended
renewal of DML.
201. M/s Shrooq
Pharmaceuticals Pvt
Ltd, 21-Km,
Ferozepur Ropad,
Near Masjid
Ibrahim, Lahore.
Lipton Oral
Solution
80mg/20mg
Each ml contains:
Lopinavir……..80mg
Ritonavir……..20mg
Dy. No. 6195
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 07-06-2017 and 30-
08-2017 recommended
renewal of DML.
202. M/s Macter
International
Limited, F-216,
S.I.T.E, Karachi.
MACLETR
A 80mg
+20mg/ml
oral solution
Each ml contains:
Lopinavir……..80mg
Ritonavir……..20mg
Dy.No. 5901
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Inspection conducted on
23-01-2019 concludes
the firm is considered to
be operating at good level
of GMP.
203. M/s Hamaz
Pharmaceuticals
(Pvt.) Ltd. 13-Km,
Bosan Road,
Lutfabad, Multan
NOVAPIR
80mg/20mg
oral Solution
Each ml contains:
Lopinavir……..80mg
Ritonavir……..20mg
Dy.No. 5916
dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm is granted GMP
certificate based on
inspection conducted on
28-09-2019.
204. M/s Sami
Pharmaceuticals, S-
95, SITE, Karachi.
Opna Oral
Solution
80mg/20mg
Each ml contains:
Lopinavir…..80mg
Ritonavir…..20mg
Dy. No. 6252
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP certificate issued
on 14-06-2018.
205. M/s Ipram
International
Pharmaceuticals
Plot#26, Street#
S.S-3 National
Industrial Zone,
(RCCI) Rawat,
Islamabad.
Ipraviz
powder for
oral
suspension
80mg/20mg
Each ml contains:
Lopinavir…..80mg
Ritonavir…..20mg
Dy.No. 6392
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Certificate of cGMP is
issued to the firm based
on inspection conducted
on 20th December, 2018.
Minutes of 294th Meeting of Registration Board | 33
206. M/s English
Pharmaceutical
Industries Link
Kattar Bund Road
Thokar Niaz Baig
Multan Road
Lahore.
Loretra
80mg/20mg
syrup
Each ml contains:
Lopinavir…..80mg
Ritonavir…..20mg
Dy.No. 6476
dated
09/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
date 17-18/01/2019, fair
compliance
Decision: Registration Board approved registration of above applications from Serial No. 197 to 205.
Conditions regarding validity of registration and data requirement will be same as decided by Board in its
general decision.
7. Lopinavir/Ritonavir (100mg/25mg) Tablet:
Composition:
Each film Coated Tablet contains:
Lopinavir……..100mg
Ritonavir……..25mg
Reference Regulatory Authority status:
Kaletra (100mg/25mg) Film coated tablet by M/s Abbvie, USFDA Approved.
Generic status: Not registered
Specifications: USP Specification
Sr.
No.
Name of
applicant
Brand Name composition Diary no. /
Date / fee /
Form
Pack
Size /
Price
Remarks/GMP status
207. M/s Horizon
Health Care Pvt
Ltd, Plot 35 A,
Small Industrial
Estate, Taxila.
Lopira film
coated tablet
100/25mg
Each film Coated
Tablet contains:
Lopinavir……..100mg
Ritonavir……..25mg
Dy. No.
6175 dated
08/04/2020
Rs. 20,000/-
+ 30,000/-
Form 5D
As per
SRO
Last GMP inspection was
conducted on 25-06-
2018 and the report
concludes that company
has shown good response
and rectified problems
and has shown good
compliance as per
schedule B-II.
208. M/s Allmed (pvt)
Ltd. Plot no. 590,
sundar Industrial
Estate Lahore.
Orita
100+25mg
tablet
Each film Coated
Tablet contains:
Lopinavir……..100mg
Ritonavir……..25mg
Dy.No. 6175
08/04/2020
Rs. 50,000/-
Form 5D
As per
SRO
Last inspection report
dated 01/01/2020, GMP
compliant.
Decision: Registration Board approved registration of above applications from Serial No. 206 to
207. Conditions regarding validity of registration and data requirement will be same as decided
by Board in its general decision.
Minutes of 294th Meeting of Registration Board | 34
8. Oseltamivir Phosphate capsule 75mg: Composition: Each capsule conatins: Oseltamivir as phosphate…….75mg Reference Regulatory Authority status: Tamiflu 75mg capsule (oseltamivir as phosphate) by M/s Roche, USFDA Approved. Generic status status: Tamiflu 75mg capsule by M/s Roche. Specifications: USP Specification
Sr.
No.
Name of applicant Brand
Name
composition Diary no. /
Date / fee /
Form
Pack
Size /
Price
Remarks
209. M/s MartinDow Limited, Plot no. 37, sector 19, Korangi Industrial Area Karachi.
Dowflu Capsules
75mg
Each capsule contains: Oseltamivir as phosphate ….. 75mg
Dy.No.5859 Dated 07/04/2020 Rs. 20,000/-
As per SRO
The firm was operating at good level of compliance with GMP as per inspection report dated 06/12/2018.
210. M/s Aulton Phamraceutical, plot # 84/1, Block A, Phase V, Industrial Estate Hattar.
Aultaflu 75mg
Capsule
Each capsule contains: Oseltamivir as phosphate ….. 75mg
Dy.No.5948 dated 07/04/2020 Rs. 20,000/- Form 5
As per SRO
The firm was last inspected on 13.02.2018, the firm was operat\ing at good level of compliance with cGMP guidelines
211. M/s Sapient Pharma, 123-S Industrial Area, Kot Lakhpat, Lahore contract manufacturing by M/s Bio-Mark Pharmaceuticals, Plot#527-sundar industrial estate, Lahore
Salmivir 75mg
capsule
Each capsule contains: Oseltamivir as phosphate ….. 75mg
Dy.No.5785 dated 27/03/2020 Rs. 20,000/- Form 5
As per SRO
The firm was GMP compliant on the day of inspection dated 13/02/2020
212. M/s Briel Pharmaceuticals (Pvt) Ltd. 538-C, Sundar Industrial Estate, Lahore.
Ostavir 75mg
capsule
Each capsule contains: Oseltamivir as phosphate ….. 75mg
Dy.No.5930 dated 07/04/2020 Rs. 20,000/- Form 5
As per SRO
Last inspection report 24/05/2019, firm was found to be operated at satisfactory level of GMP compliance.
213. M/s Seraph Pharmaceuticals, Plot#210, Industrial Triangle, Kahuta Road, Islamabad.
Osmivir capsule 75mg
Each capsule contains: Oseltamivir as phosphate ….. 75mg
Dy.No.5574 06/04/2020 Rs. 20,000/- Form 5
As per SRO
GMP certificate issued on the basis of inspection conducted on 11/07/2019.
214. M/s Wimits Pharmaceuticals (pvt) Ltd. Plot No. 129, sundar Industrial Estate (PIE) Raiwind Road, Lahore.
Osmir 75mg capsule
Each capsule contains: Oseltamivir as phosphate ….. 75mg
Dy. No. 5538 Dated 06/04/2020 Rs. 20,000/- Form 5
As per SRO
GMP Certificate issued on 10-12-2018.
215. M/s Bio-Mark Pharmaceuticals, plot No. 527-sundar industrial estate, Lahore.
Boselta 75mg
capsule
Each capsule contains: Oseltamivir as phosphate ….. 75mg
Dy.No. 5322 dated 27/03/2020 Rs. 20,000/- Form 5
As per SRO
Firm was GMP compliant on inspection day dated 13/02/2020. Method of manufacturing is not as per innovator’s product.
Minutes of 294th Meeting of Registration Board | 35
216. M/s Crystolite Pharma, Plot#1&2, St.S-2, National Industrial Zone, Rawat, Islamabad
Flulite 75mg Capsule
Each capsule contains: Oseltamivir as phosphate ….. 75mg
Dy.No. 5568 dated 06/04/2020 Rs. 20,000/- Form 5
As per SRO
DML renewed vide letter No.F.1-54/2009-Lic (Vol-I) dated 6th March 2019.
217. M/s Invictus Pharmaceuticals Plot No.21, 26, Street No. NS-2, National Industrial Zone (RCCI) Rawat Rawalpindi.
Oseflu 75mg capsule
Each capsule contains: Oseltamivir as phosphate ….. 75mg
Dy.No.10104 04/03/2019 Rs. 20,000/- Form 5
As per SRO
Last inspection report 13.11.18 & 17/12/2018, the panel recommends the grant of DML for tablet (general) & Capsule (General) section.
218. M/s MartinDow Marker Ltd. (formerly Meck (pvt) ltd) 7, jail road Quetta.
Covoflu Capsule 75mg
Each capsule contains: Oseltamivir as phosphate ….. 75mg
Dy. No. 5774 07/04/2020 Rs. 20,000/- Form 5
As per SRO
The firm’s GMP compliance level is rated as good as per inspection report dated 12/07/2019.
219. M/s Neutro Pharma (Pvt) Ltd. 9.5 KM, Sheikhupura Road, Lahore.
Selvir 75mg capsules
Each capsule conatins: Oseltamivir as phosphate…….75mg
Dy.No.11337 05/03/2019 Rs. 20,000/- Form 5
As per SRO
Last inspection report dated 18/07/2017, fair level of GMP compliance.
220. M/s The Searle Company Ltd,F-319,SITE., Karachi.
Seflu 75mg capsule
Each capsule conatins: Oseltamivir as phosphate…….75mg
Dy. No. 5798 07/04/2020 Rs. 20,000/- Form 5
As per SRO
GMP certificate issued on 22/07/2019.
221. M/s Life Pharmaceutical Company, 24-III, Industrial Estate, Multan.
Miviron Capsule 75mg
Each capsule conatins: Oseltamivir as phosphate…….75mg
Dy. No. 6171 Dated 08/04/2020 Rs. 20,000/- Form 5
As per SRO
Last inspection report dated 15/01/2018, satisfactory level of GMP compliance.
222. M/s Medpharm research Lab, 28 km ferozpur road Lahore.
Medflu 75mg
Capsule
Each capsule conatins: Oseltamivir as phosphate…….75mg
Dy. No. 6182 08/04/2020 Rs. 20,000/- Form 5
As per SRO
DML issued on 26/02/2018.
223. M/s Aurik Pharmaceuticals, Plot#6&7,St #S-9 national industrial zone, Rawat Islamabad.
Selta-75mg Capsule
Each capsule conatins: Oseltamivir as phosphate…….75mg
Dy.No. 5793 dated 07/04/2020 Rs. 20,000/- Form 5
As per SRO
Last inspection report dated 05/09/2018, the firm was complying with GMP standards.
224. M/s Next Pharmaceutical Products (Pvt) Ltd.,Plot#44 A-B, Sundar Industrial Estate, Lahore.
Oseltanext 75mg
capsule
Each capsule conatins: Oseltamivir as phosphate…….75mg
Dy.No. 6159 dated 08/04/2020 Rs. 20,000/- Form 5
As per SRO
GMP certificate issued on 08/07/2019.
225. M/s Tabros Pharma (Pvt.) Ltd Plot No.L-20/B, Karachi Industrial Area, Sector-22, Federal B Area, Karachi.
Flunor 75mg capsule
Each capsule: Oseltamivir as phosphate ….. 75mg
Dy. No. 5892 07-04-2020 Rs. 20,000/- Form 5
As per SRO
Last GMP inspection conducted on 07/02/18 & report concludes on the basis of current inspection it was observed that the firm rectified all observations noted during last GMP Inspection
Minutes of 294th Meeting of Registration Board | 36
226. M/s Navegal Laboratories 41/1-A2, Phase-1, Industrial Estate Hattar
Oslu 75mg Capsule
Each capsule: Oseltamivir as phosphate ….. 75mg
Dy.No.39117 28-11-2018 Rs. 20,000/- Form 5
As per SRO
The firm was inspected on 31.12.16, wherein renewal of DML was recommended.
227. M/s. Athan Pharmaceuticals Plot No 84/1, block B, Phase V industrial Estate, Hattar
Athflu 75mg Capsule
Each capsule: Oseltamivir as phosphate ….. 75mg
Dy. No. 5954 07-04-2020 Rs. 20,000/- Form 5
As per SRO
New DML issued on 5-03-2019
228. M/s Albro Pharma
(Pvt) Ltd.
340-S Industrial state,
Kot Lakhpat, Lahore,
Sytavir
75mg
Capsule
Each capsule:
Oseltamivir as
phosphate ….. 75mg
Dy. No. 6231
08-04-2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP dated 30-05-
2019 concluding that
firm is complying most
of GMP guidelines.
229. M/s. Shaigan Pharma,
14 Km Adyala Road,
Rawalpindi.
Tamivir
75mg
Capsule
Each capsule:
Oseltamivir as
phosphate ….. 75mg
Dy. No. 6189
08-04-2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP 30-5-19
concluding that firm is
complying 25-9-19
Panel recommended
renewal of DML most
of GMP Guidelines.
230. M/s. Linear Pharma,
Plot#18, St.#S-4,
National Industrial
Zone, RCCI, Rawat,
Islamabad.
Oslivir
75mg
Capsule
Each capsule:
Oseltamivir as
phosphate ….. 75mg
Dy. No. 6187
08-04-2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP dated 30-01-
2019 concluding that
firm is operating at
satisfactory level of
compliance with GMP
standards
231. M/s Sami
Pharmaceuticals, S-
95, SITE, Karachi.
Flunar 75mg
Capsule
Each capsule:
Oseltamivir as
phosphate ….. 75mg
Dy. No. 6169
08-04-2020
Rs. 20,000/-
Form 5
As per
SRO
GMP certificate issued
on 14-06-2018.
232. M/s Pharmix Lab. 21-
Km Ferozepur Road,
Lahore.
Ostam 75mg
Capsule
Each capsule:
Oseltamivir as
phosphate ….. 75mg
Dy. No. 6219
08-04-2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP dated 30-01-
2019 concluding that
firm is operating at
satisfactory level of
compliance with GMP
standards
233. M/s Shrooq
Pharmaceuticals Pvt
Ltd, 21-Km,
Ferozepur Ropad,
Near Masjid Ibrahim,
Lahore.
Onnil 75mg
Capsule
Each capsule:
Oseltamivir as
phosphate ….. 75mg
Dy. No. 6194
08-04-2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 07-06-2017 & 30-
08-2017 recommended
renewal of DML.
234. M/s Macter
International Limited,
F-216, S.I.T.E,
Karachi.
Macflu
75mg
capsule
Each capsule
Contains:
Oseltamivir as
phosphate ….. 75mg
Form 5
Dy. No. 5900
07/04/2020
Rs.20,000/-
As per
SRO
Inspection conducted on
23-1-2019 concludes
that firm is considered to
be operating at good
level of GMP.
235. M/s. GLITZ Pharma,
Plot No. 265,
Industrial Triangle
Kahuta Road,
Islamabad
Glitflu 75mg
capsule
Each capsule
Contains:
Oseltamivir as
phosphate ….. 75mg
Form 5
Dy. No. 5877
07/04/2020
Rs.20,000/-
As per
SRO
Panel inspection
conducted on 16-01-
2019 recommended
issuance of GMP
certificate.
Minutes of 294th Meeting of Registration Board | 37
236. M/s Winlet
Pharmaceuticals. 30-
km, Lahore Sargodha
Road, Lahore
WINFLU
75mg
capsule
Each capsule
Contains:
Oseltamivir as
phosphate ….. 75mg
Form 5
Dy. No. 6129
07/04/2020
Rs.20,000/-
As per
SRO
The firm is granted New
DML based on
inspection dated 05-12-
2017.
237. M/s Hamaz
Pharmaceuticals
(Pvt.) Ltd. 13-Km,
Bosan Road,
Lutfabad, Multan
OSELTA
75mg
Capsule
Each capsule
Contains:
Oseltamivir as
phosphate ….. 75mg
Form 5
Dy. No. 5923
dated
07/04/2020
Rs.20,000/-
As per
SRO
The firm is granted GMP
certificate based on
inspection conducted on
28-09-2019.
238. M/s CCL
Pharmaceuticals
(Pvt.) Ltd., 62-
Industrial Estate, Kot
Lakhpat, Lahore
Temevir
75mg
Capsule
Each capsule
Contains:
Oseltamivir as
phosphate ….. 75mg
Form 5
Dy. No. 5941
dated
07/04/2020
Rs.20,000/-
As per
SRO
The firm was granted
GMP certificate based on
inspection dated 24-04-
2018.
239. M/s Moringa
Pharmaceuticals, 35-
A Sundar Industrial
Estate, Lahore
OMEVIR
Capsule
75mg
Each capsule
Contains:
Oseltamivir as
phosphate ….. 75mg
Dy. No. 6278
dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm is granted GMP
certificate based on
inspection conducted on
30-05-2019.
240. Pulse Pharmaceuticlas
(Pvt) Ltd. Raiwind
Road Lahore.
Pulsevir
75mg
Capsule
Each capsule
conatins:
Oseltamivir as
phosphate…….75mg
Dy.No. 6124
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Certificate of cGMP is
issued to the firm based
on evaluation
conducted on 10th May,
2017
241. M/s Genome
Pharmaceuticals Pvt
Ltd. Plot # 16/I-Phase
IV, Industrial Estate,
Hattar.
Flugen
75mg
Capsule
Each capsule
conatins:
Oseltamivir as
phosphate…….75mg
Dy.No. 6148
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The inspection report
dated 12.5.18
concluded that overall
firm was operating
under good level of
cGMP
242. M/s Searle IV Solutions
Pvt Ltd. 1.5 km, Manga
Raiwind Road, Lahore
Macmivir
75mg
Capsule
Each capsule
conatins:
Oseltamivir as
phosphate…….75mg
Dy.No. 6136
24/03/2020
Rs. 20,000/-
Form 5
As per
SRO
27-02-2018. GMP
Certificate issued on 15-
03-2018.
243. M/s NabiQasim
Industries (PVT)
Limited. 17/24,
Korangi Industrial
Area, Karachi.
Onzir
Capsule
75mg
Each capsule
conatins:
Oseltamivir as
phosphate…….75mg
Dy.No. 6139
24/03/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 02/8/18 concludes
the GMP compliance as
good.
244. M/S Indus Pharma (Pvt)
Ltd., Plot No. 26, 27,63,
64, 65,66&67, Sector-
27, Korangi Industrial
Area. Karachi.
Iveltar
75mg
Capsule
Each capsule
conatins:
Oseltamivir as
phosphate…….75mg
Dy.No. 6147
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection on 16-8-
2017 & report
concludes that firm was
considered to be
operating at an
acceptable level of
GMP compliance
245. M/s Wnsfeild
Pharmaceuticals, Plot
No. 122, Phase V,
Block A, Industrial
Estate Hatter, KPK
Osimavir
75mg
Capsule
Each capsule
conatins:
Oseltamivir as
phosphate…….75mg
Dy.No. 6288
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Panel inspection dated
18-01-2018
unanimously
recommends renewal of
DML no. 000610 by
way of formulation.
246. M/s Wenovo
Pharmaceuticals
Ozwir
75mg
Capsule
Each capsule
conatins:
Dy.No. 6293
dated
As per
SRO
Last GMP inspection on
30-09-2018 & 29-10-
2018 and report
Minutes of 294th Meeting of Registration Board | 38
Plot # 31& 32 Punjab
Small Industrial Estate
Taxila Pakistan
Oseltamivir as
phosphate…….75mg
08/04/2020
Rs. 20,000/-
Form 5
concludes that Firm is
compliant to current
GMP
247. M/s Polyfine
Chempharma.
51-Industrial Estate,
Hayatabad, Peshawar,
Pakistan
Ozelta
75mg
Capsule
Each capsule
conatins:
Oseltamivir as
phosphate…….75mg
Dy.No. 6300
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP inspection on
7-2-18 & report
concludes that Based on
the area inspected the
people met, document
reviewed and
considering the findings
of inspection firm was
considered to be
operated at acceptable
level of compliance
with GMP guideline
248. M/s Pearl
Pharmaceuticals.
Plot No. 204, Street
No.1, I-10/3, Islamabad
Coniflu
75mg
Capsule
Each capsule
conatins:
Oseltamivir as
phosphate…….75mg
Dy.No. 6301
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
23-7-2018, Firm was
found in satisfactory
compliance with GMP
guidelines.
249. M/s Allmed Pvt Ltd. Plot No. 590, Sundar Industrial Estate, Lahore, Pakistan
Ostavir
75mg
capsule
Each capsule:
Oseltamivir as
phosphate ….. 75mg
Dy. No. 6239
08-04-2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP inspection
conducted on 01-1-20 &
report concludes GMP
compliance.
250. M/s MTI Medical (Pvt) Ltd, 586-587, Sundar Industrial Estate, Lahore
Osetavir
75mg
capsule
Each capsule
Contains:
Oseltamivir as
phosphate ….. 75mg
Form 5
Dy. No. 6263
08/04/2020
Rs.20,000/-
As per
SRO
The firm is granted
GMP certificate based
on inspection
conducted on 25-9-19.
251. M/s Himark Pharma (Pvt) Ltd. Plot#37-A, Sundar Industrial Estate, Lahore
Osemark
75mg
Capsules
Each capsule
Contains:
Oseltamivir as
phosphate ….. 75mg
Form 5
Dy. No. 6274
08/04/2020
Rs.20,000/-
As per
SRO
New license
252. M/s Ipram International Pharma Plot#26, St.#S.S-3 National Industrial Zone, (RCCI) Rawat, Islamabad.
Covi-flu
75mg
capsule
Each capsule
conatins:
Oseltamivir as
phosphate….75mg
Dy.No. 6394
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Certificate of cGMP is
issued to the firm
based on inspection
conducted on 20th
december, 2018.
253. M/s English Pharmaceutical Industries, Link Kattar Bund Road Thokar Niaz Baig Multan Road Lahore.
Osevir
75mg
capsule
Each capsule
conatins:
Oseltamivir as
phosphate…….75mg
Dy.No. 6475
dated
09/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
date 17-18/01/2019,
fair compliance
Decision: Registration Board approved registration of above applications from Serial No. 208 to 253.
Conditions regarding validity of registration and data requirement will be same as decided by Board in
its general decision.
Minutes of 294th Meeting of Registration Board | 39
9. Oseltamivir Phosphate dry suspension : Composition:
Each ml of reconstituted suspension contains:
Oseltamivir as phosphate……..12mg
Reference Regulatory Authority status:
Tamiflu 12mg/ml for Suspension (oseltamivir as phosphate) by M/s Roche, Italy AIFA Approved.
Generic status:
Ozenta 12mg Dry Suspensin by M/s Hilton, reg. No. 42219
Specifications: Innovator’s Sr.
No.
Name of applicant Brand Name Composition Diary no. /
Date / fee /
Form
Pack
Size /
Price
Remarks/GMP status
254. M/s Goodman Laboratories (Pvt) Ltd, Plot#5 St.#S-5, National Industrial Zone Rawat.
Tamivir dry suspension
Each ml of reconstituted suspension contains: Oseltamivir as phosphate…..12mg
Dy. No.13489 07/04/2020 Rs. 20,000/- Form 5
As per SRO
GMP certificate issued on the basis of inspection conducted on 08/08/2018.
Decision: Registration Board approved registration of above application while conditions regarding validity of registration and data requirement will be same as decided by Board in its general decision.
10. Ascorbic acid chewable tablet 500mg:
Composition:
Each chewable tablet contains:
Ascorbic acid……..500mg
Reference Regulatory Authority status: Ascorbic acid chewable tablet 500mg
Generic status: Cecon 500mg tablet by M/s Abbott.
Specifications: USP
Sr.
No.
Name of applicant Brand Name Composition Diary no. /
Date / fee /
Form
Pack
Size /
Price
Remarks/GMP status
255. M/s Metro
Pharmaceuticals Plot #
14, Street No. SS-2,
National Industrial
Zone, Rawat,
Islamabad.
Meta-C tablet
500mg
Each chewable tablet
contains:
Ascorbic
acid…500mg
Dy. No.
5854
Dated
07/04/2020
Rs. 20,000/-
As per
SRO
The panel recommended
renewal of DML,
inspection date
17/05/2019
256. M/s Aulton
Phamraceutical, plot #
84/1, Block A, Phase
V, Industrial Estate
Hattar.
Ascort 500mg
tablet
Each chewable tablet
contains:
Ascorbic acid …….
500mg
Dy. No.
5943
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm was last
inspected on 13.02.2018,
the firm was operating at
good level of compliance
with cGMP guidelines
257. M/s Aries
Pharmaceuticals 1-W,
Industrial Estate
Hayatabad Peshawar.
C 500 tablet Each chewable tablet
contains:
Ascorbic acid …….
500mg
Dy.No.5772
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 10/03/2017, panel
recommended for grant
of GMP certificate.
258. M/s Briel
Pharmaceuticals (pvt)
Ltd. 538-C, Sundar
Industrial Estate
Lahore.
B-Quine
500mg
chewable
tablet
Each chewable tablet
contains:
Ascorbic acid …….
500mg
Dy.#5932
dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 24/05/2019, firm
was found to be operated
at satisfactory level of
GMP compliance.
259. M/s Martin Dow
Limited, Plot no. 37,
sector 19, Korangi
Dow-C tablet
500mg
Each chewable tablet
contains:
Dy.No.5860
07/04/2020
Rs. 20,000/-
As per
SRO
The firm was operating
at good level of
compliance with GMP as
Minutes of 294th Meeting of Registration Board | 40
Industrial Area
Karachi.
Ascorbic acid …….
500mg
per inspection report
dated 06/12/2018.
260. M/s Wimits
Pharmaceuticals (pvt)
Ltd. Plot#129, sundar
Industrial Estate (PIE)
Raiwind road Lahore.
Vita-C 500mg
tablet
Each chewable tablet
contains:
Ascorbic acid …….
500mg
Dy.No.5773
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP Certificate issued
on 10-12-2018.
261. M/s Genix pharma
Private Limited.
Karachi
Carb-C
tablets 500mg
Each chewable tablet
contains:
Ascorbic acid …….
500mg
Dy.No.
5768
7/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 10/4/19,
acceptable level of
compliance GMP
guidelines.
262. M/s Sapient Pharma,
123-S Industrial Area,
Kot Lakhpat, Lahore.
Sapsi tablet
500mg
Each chewable tablet
contains:
Ascorbic acid …….
500mg
Dy. No.
5783
27/03/2020
Rs. 20,000/-
Form 5
As per
SRO
Panel inspection dated
19-9-2019 & 18-11-
2019 recommended
renewal of DML.
263. M/s Caliph
Phrmaceuticals (Pvt)
Ltd. Plot#17, special
industrial zone (EPZ),
Risalpur, KPK.
Cecal
Chewable
tablet
Each chewable tablet
contains:
Ascorbic acid …….
500mg
Dy.No.
5851 dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 06/11/2018, the
panel recommended
renewal of DML.
264. M/s Bio-Mark
Pharmaceuticals, plot
No. 527-sundar
industrial estate,
Lahore.
Bio-scorb
tablet 500mg
Each chewable tablet
contains:
Ascorbic
acid……500mg
Dy.No.
5321 dated
27/03/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm was GMP
compliant on the day of
inspection dated
13/02/2020. Method of
manufacturing is not as
per innovator’s product.
265. M/s Crystolite
Pharmaceuticals,
Plot# 1&2, Street
No.S-2, National
Industrial Zone,
Rawat, Islamabad.
Ascon-C
500mg tablet
Each chewable tablet
contains:
Ascorbic
acid……500mg
Dy.No.
5569 dated
06/04/2020
Rs. 20,000/-
Form 5
As per
SRO
DML renewed vide letter
No.F.1-54/2009-Lic
(Vol-I) dated 6th march
2019.
266. M/s Seraph
Pharmaceuticals,
Plot#210, Industrial
Triangle, Kahuta
Road, Islamabad.
C-lime
chewable
tablet 500mg
Each chewable tablet
contains:
Ascorbic
acid……500mg
Dy.No.
5575 dated
06/04/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP certificate issued
on the basis of inspection
conducted on
11/07/2019.
267. M/s MartinDow
Marker Ltd. (formerly
Meck (Pvt) Ltd) 7, jail
road Quetta.
Cevion
chewable
tablet 500mg
Each chewable tablet
contains:
Ascorbic
acid……500mg
Dy. No.
5775
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm’s GMP
compliance level is rated
as good as pe the
inspection report dated
12/07/2019.
268. M/s Medisynth
Pharmaceuticals (Pvt)
Ltd. Plot#55 Street S-
5, NIZ, Rawat.
Calsynth
500mg tablets
Each chewable tablet
contains:
Ascorbic
acid……..500mg
Dy.No.
5789
07/04/2019
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
01/03/2019, satisfactory
level of GMP.
269. M/s The Searle
Company Limited, F-
319 SITE., Karachi.
Sorby 500mg
tablet
Each chewable tablet
contains:
Ascorbic
acid……..500mg
Dy.No.5799
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP certificate issued
on 22/07/2019.
Minutes of 294th Meeting of Registration Board | 41
270. M/s Medpharm
research Lab, 28 km
ferozpur road Lahore.
Med C-500
Chewable
tablet
Each chewable tablet
contains:
Ascorbic
acid……..500mg
Dy.No.6179
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
DML issued on
26/02/2018
271. M/s Cunningham
Pharmaceuticals (Pvt)
Ltd. Plot#81 Sundar
Industrial Estate
Raiwing Road,Lahore
C-Rise
500mg
Chewable
tablet
Each chewable tablet
contains:
Ascorbic
acid……..500mg
Dy.No.6198
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm has maintained
conformance to GMP
compliance as per
inspection report dated
01/04/2019.
272. M/s Hygeia
Pharmaceuticals
industrial triangles
kahuta road
Islamabad.
C-Quic
500mg Tablet
Each chewable tablet
contains:
Ascorbic
acid……..500mg
Dy.No.5862
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
21/09/2017, satisfactory
level of GMP
compliance.
273. M/s Davis
Pharmaceutical
Laboratories,Plot#121
Industrial Triangle
Area, Kahuta Road
Islamabad.
Daily C 500
tablet
Each chewable tablet
contains:
Ascorbic
acid……..500mg
Dy.No.6170
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
01/10/2019, Renewal of
DML.
274. M/s Werrick
Pharmaceuticals, 216-
217, I-10/3, Industrial
Area, Islamabad.
Werrick’s
vitamin C
500mg
chewable
tablet
Each chewable tablet
contains:
Ascorbic
acid……..500mg
Dy.No.
6161
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 09/11/2018, panel
recommended grant of
GMP certificate.
275. M/s Next
Pharmaceutical
Products (Pvt)Ltd
Plot#44 A-B, Sundar
Industrial Estate,
Lahore.
C-Mext
500mg tablet
Each chewable tablet
contains:
Ascorbic
acid……..500mg
Dy.No.
6152
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
GMP certificate issued
on 08/07/2019.
276. M/s Genetics Pharma
(Pvt) Ltd, 539-A,
Sundar Industrial
Estate, Raiwind,
Lahore.
Cascor
500mg
chewable
tablet
Each chewable tablet
contains:
Ascorbic
acid……..500mg
Dy.No.
6302
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 29/03/2019, firm
was operation at
satisfactory level of
GMP compliance.
277. M/s Tabros Pharma
(Pvt.) Ltd Plot No.L-
20/B, Karachi
Industrial Area,
Sector-22, Federal B
Area, Karachi.
Sensit-C
500mg
Chewable
tablet
Each chewable tablet
contains:
Ascorbic acid …….
500mg
Dy. No.
5894 dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP inspection
conducted on
07/2/18and report
concludes on the basis of
current inspection it was
observed that the firm
rectified all observations
noted during last GMP
Inspection.
Minutes of 294th Meeting of Registration Board | 42
278. M/s Fresh
Pharmaceutical, Plot
No. 07, Street No. S-6,
National Industrial
Zone, RCCI, Rawat,
Rawalpindi.
Ascor 500mg
Chewable
tablet
Each chewable tablet
contains:
Ascorbic
acid…500mg
Dy.No.5910
dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection dated
02-10-2019 complying
satisfactory level
cGMP
279. M/s Glitz Pharma, Plot
No 265, Industrial
Triangle, Kahuta
Road, Islamabad.
Vita-C 500mg
Chewable
tablet
Each chewable tablet
contains:
Ascorbic
acid…500mg
Dy.No.5881
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Issuance of GMP
certificate dated 16-01-
2019
280. M/s EG
Pharmaceuticals,
Industrial Triangle
Kahuta road,
Islamabad.
Cec Cec
500mg
Chewable
tablet
Each chewable tablet
contains:
Ascorbic
acid…500mg
Dy.No.5927
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Renewal of DML
recommended in the
inspection dated 13-02-
2019
281. M/s. Athan
Pharmaceuticals
Plot#84/1, Block B,
Phase-V industrial
Estate, Hattar.
Athanart
500mg tablet
Each chewable tablet
contains:
Ascorbic
acid…500mg
Dy.No.5949
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
New DML issued on 5-
03-2019
282. M/s. Shaigan Pharma,
14 Km Adyala Road,
Rawalpindi.
Ascomin
Chewable
tablets 500mg
Each chewable tablet
contains:
Ascorbic acid …….
500mg
Dy.No.6791
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
25-9-2019 Panel
recommended the
renewal of DML
283. M/s. Wilson’s
Pharmaceuticals, 387-
388, I-9, Sector,
Industrial Area,
Islamabad.
Wilson’s
Vitamin-C
Chewable
tablets 500mg
Each chewable tablet
contains:
Ascorbic acid …….
500mg
Dy.No.6212
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
24-01-2018 Good level
of CGMP Compliance
284. M/s. Pharmix Lab. 21-
Km Ferozepur Road,
Lahore.
Cemax
Chewable
tablets 500mg
Each chewable tablet
contains:
Ascorbic acid …….
500mg
Dy.No.6218
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 13/09/2019. The
panel recommended
renewal of DML.
285. M/s Albro Pharma
Private Limited.
340-S Industrial state,
Kot Lakhpat, Lahore,
Pakistan.
Ascobro
tablets 500mg
Each chewable tablet
contains:
Ascorbic acid …….
500mg
Dy.No.6233
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP dated 30-05-
2019 concluding that firm
is complying most of the
GMP guidelines.
286. M/s CCL
Pharmaceuticals
(Pvt.) Ltd., 62-
Industrial Estate, Kot
Lakhpat, Lahore
C-VIT Tablet
500mg
Each chewable tablet
contains:
Ascorbic acid …….
500mg
Dy. No.
5934 dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm was granted
GMP certificate based on
inspection dated 24-04-
2018.
287. M/s Winlet
Pharmaceuticals. 30-
km, Lahore Sargodha
Road, Lahore
SCORBLET
Tablet 500mg
Each chewable tablet
contains:
Ascorbic acid …….
500mg
Dy. No.
6127 dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm is granted New
Drug Manufacturing
License
based on inspection
Dated 05-12-2017.
288. M/s Hiranis
Pharmaceuticals (Pvt)
Ltd. Plot# E-145 to E-
149, North Western
Industrial Zone, Port
Qasim, Karachi
Hawk-C
Tablet 500mg
Each chewable tablet
contains:
Ascorbic acid …….
500mg
Dy. No.
5769 dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm is granted New
Drug Manufacturing
License
based on inspection
Dated 05-12-2017.
Minutes of 294th Meeting of Registration Board | 43
289. M/s Hamaz
Pharmaceuticals
(Pvt.) Ltd. 13-Km,
Bosan Road,
Lutfabad, Multan
Vita-C
Chewable
500mg Tablet
Each chewable tablet
contains:
Ascorbic acid …….
500mg
Dy. No.
5913 dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm is granted GMP
certificate based on
inspection conducted on
28-09-2019.
290. M/s SNB Pharma
(Pvt) Ltd. 142,
Industrial Estate,
Hayatabad, Peshawar
SN-C500mg
Tablet
Each chewable tablet
contains:
Ascorbic acid …….
500mg
Dy. No.
6222 dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm is granted GMP
certificate based on
inspection conducted on
10-10-2019.
291. M/s Gray’s
Pharmaceutical, Plot #
2, Street No N-3,
national industrial
Zone, Rawat
C-Gain
500mg Tablet
Each chewable tablet
contains:
Ascorbic acid …….
500mg
Dy. No.
5867 dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Inspection conducted on
23-05-2019 overall GMP
compliance graded as
Good.
292. M/s Moringa
Pharmaceuticals, 35-
A Sundar Industrial
Estate, Lahore
C-MOR
500mg
Tablet
Each chewable tablet
contains:
Ascorbic acid …….
500mg
Dy. No.
6276 dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The firm is granted GMP
certificate based on
inspection conducted on
30-05-2019.
293. M/s Searle IV Solutions
Pvt Ltd. 1.5 km, Manga
Raiwind Road, Lahore
Macorbic
500mg
chewable
Tablet
Each chewable tablet
contains:
Ascorbic
acid……..500mg
Dy.No. 6138
24/03/2020
Rs. 20,000/-
Form 5
As per
SRO
27-02-2018. GMP
Certificate issued on 15-
03-2018.
294. M/s Genome
Pharmaceuticals Pvt
Ltd.
Plot # 16/I-Phase IV,
Industrial Estate,
Hattar, KPK
Ascarb-C
chewable
500mg
Tablet
Each chewable tablet
contains:
Ascorbic
acid……..500mg
Dy.No. 6149
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
The inspection report
dated 12.05.2018
concluded that overall the
firm was operating under
good level of cGMP.
295. M/s Olive Laboratories,
52-56 National
Industrial Zone, Rawat,
Rawalpindi
C-Live
500mg
Tablet
Each chewable tablet
contains:
Ascorbic
acid……..500mg
Dy.No. 6132
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Inspection report dated
05-03-2019 confirms the
firm is operating in
compliance with GMP.
296. M/s Invictus
Pharmaceuticals.
Plot No. 21,26, Street
No.NS-2, National
Industrial Zone, Rawat,
Rawalpindi
Vit-C 500mg
Chewable
Tablet
Each chewable tablet
contains:
Ascorbic
acid……..500mg
Dy.No. 5855
dated
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
13-11-2018, The panel
recommended the grant of
DML
297. M/s Wnsfeild
Pharmaceuticals, Plot
No. 122, Phase V,
Block A, Industrial
Estate Hatter, KPK
VIT-C
500mg
Tablet
Each chewable tablet
contains:
Ascorbic
acid……..500mg
Dy.No. 6284
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Panel inspection dated
18-01-2018 unanimously
recommends renewal of
DML no. 000610 by way
of formulation.
298. M/s Wenovo
Pharmaceuticals
Plot # 31& 32 Punjab
Small Industrial Estate
Taxila Pakistan
Azbic
500mg
Tablet
Each chewable tablet
contains:
Ascorbic
acid……..500mg
Dy.No. 6290
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP inspection
conducted on 30-09-2018
& 29-10-2018
and report concludes that
Firm is compliant to
current GMP
Minutes of 294th Meeting of Registration Board | 44
299. M/s Polyfine
Chempharma.
51-Industrial Estate,
Hayatabad, Peshawar,
Pakistan
Ascon
Chewable
Tablet
500mg
Each chewable tablet
contains:
Ascorbic
acid……..500mg
Dy.No. 6295
dated
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last GMP inspection
conducted on 07-02-
2018 and report
concludes that Based on
the area inspected the
people met
and document reviewed
and considering the
findings of
inspection firm was
considered to be
operated at acceptable
level of compliance with
GMP guideline
300. M/s Islam
Pharmaceuticals,7 km,
Pasrur Road, Sialkot
Life-C
500mg
Chewable
Tablet
Each chewable tablet
contains:
Ascorbic
acid……..500mg
Dy.No.6226
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
New License (letter
issuance date: 29th
August 2018)
301. M/s Amros
Pharmaceuticals, A-
96, S.I.T.E. Super
Highway, Karachi.
AMRO-C
Chewable
Tablet
500mg
Each chewable tablet
contains:
Ascorbic
acid……..500mg
Dy.No.6250
08/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 18/07/2018
confirms thecurrent
compliance level as
Good.
302. M/s Quaper pvt. Ltd.
26-A Samll industrial
estate Lahore road
Sargodha.
Vitamin C
500mg tablet
Each chewable tablet
contains:
Ascorbic
acid……..500mg
Dy.No.5885
07/04/2020
Rs. 20,000/-
Form 5
As per
SRO
Last inspection report
dated 28/01/2019, the
panel recommends the
renewal of DML.
303. M/s Allmed Pvt Ltd.
Plot No. 590, Sundar
Industrial Estate,
Lahore, Pakistan
Acogen
tablet 500mg
Each chewable tablet
contains:
Ascorbic acid….
500mg
Dy.No. 6244
dated
08/04/2020
Rs. 20,000/-
Form 5
As
per
SRO
Last GMP inspection
conducted on 01-01-2020
and report concludes
GMP compliance.
304. M/s Welwrd
Pharmaceuticals, Plot
#03, Block A, PhaseI-
II, Industrial Estate,
Hattar
AZBIK
Tablet
500mg
Each chewable tablet
contains:
Ascorbic acid …….
500mg
Dy.No. 6283
dated
08/04/2020
Rs. 20,000/-
Form 5
As
per
SRO
Inspection conducted on
12-11-2018 the firm is
operating at satisfactory
level of GMP.
305. M/s Welwink
Pharmaceuticals, G.T.
Road, Industrial
Estate, Gujranwala
Cantt
ASCO-C
Tablet
500mg
Each chewable tablet
contains:
Ascorbic acid …….
500mg
Dy.No. 6280
08/04/2020
Rs. 20,000/-
Form 5
As
per
SRO
Inspection conducted on
20-12-2017 the firm is
operating at satisfactory
level of GMP.
306. M/s MTI Medical
(Pvt) Ltd, 586-587,
Sundar Industrial
Estate, Lahore
BOOST
Tablet
500mg
Each chewable tablet
contains:
Ascorbic acid …….
500mg
Dy.No. 6264
08/04/2020
Rs. 20,000/-
Form 5
As
per
SRO
The firm is granted GMP
certificate based on
inspection conducted on
25-09-2019.
307. M/s Himark
Pharmaceuticals (Pvt)
Ltd. Plot # 37-A,
Sundar Industrial
Estate, Lahore
Mark C
Tablet
500mg
Each chewable tablet
contains:
Ascorbic acid …….
500mg
Form 5
Dy. No. 6275
dated
08/04/2020
Rs.20,000/-
As
per
SRO
New license
308. M/s Fiends pharma,
(pvt) ltd, 31-km
ferozepur road lahore.
Vitafen
tablet 500mg
Each chewable tablet
contains:
Ascorbic
acid……..500mg
Dy.No. 6388
08/04/2020
Rs. 20,000/-
Form 5
As
per
SRO
Last inspection report
dated 08/03/2019,panel
recommended renewal of
DML.
Minutes of 294th Meeting of Registration Board | 45
Decision: Registration Board approved registration of above applications from Serial No. 255 to
308. Conditions regarding validity of registration and data requirement will be same as decided
by Board in its general decision.
Item No. 2: Agenda of Evaluator PEC-I
Vet New Section
M/s Medi-Excel Pharmaceutical, Plot No. 282, Industrial Triangle, Kahuta Road, Islamabad was granted
additional sections vide letter no. F.1-2/2001-Lic (Vol-I) dated 29/09/2019. The firm has applied for
following products against relevant sections as under.
Liquid Antibiotic Injectable Section-1 (VET)
Number of products: 05
Number of molecules: 03
1. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road, Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength Extragent CT Injection
Composition "Each 100ml Injection contains:
Tylosin Tartrate …….….10gm
Gentamicin Sulphate....…05gm
Colistin Sulphate………..20 MIU"
Diary No. Date of R& I & fee Dy. No 32404 dated 31-01-2020 Rs. 20,000/- 18-12-2019
Pharmacological Group Antibacterial
Type of Form Form-5
Finished product Specifications Innovator’s Specification
Pack size & Demanded Price 100ml/ Decontrolled
Me-too status (with strength & dosage
form)
Combigent Injection of M/s Selmore Pharmaceuticals Pvt Ltd,
(Reg.# 088086)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved.
2. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road, Humak, Islamabad 45700"
Brand Name +Dosage Form+Strength Genta XL 5 Injection
Composition Each ml Injection contains:
Gentamicin Sulphate....…50mg"
Diary No. Date of R& I & fee Dy. No 32405 dated 31-01-2020 Rs. 20,000/- 18-12-2019
Pharmacological Group Antibacterial/Antibiotic
Type of Form Form-5
Finished product Specifications USP
Pack size & Demanded Price 100ml/ Decontrolled
Me-too status (with strength and dosage
form)
Gentasel-5 Injection of M/s Selmore Pharmaceuticals Pvt Ltd,
(Reg.# 046516)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved.
3. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength Genta XL 10 Injection
Composition Each 100ml Injection contains:
Gentamicin Sulphate (eq.to Gentamicin base 10gm)..…15.9gm
Diary No. Date of R& I & fee Dy. No 32406 dated 31-01-2020 Rs. 20,000/- 18-12-2019
Pharmacological Group Antibacterial
Minutes of 294th Meeting of Registration Board | 46
Type of Form Form-5
Finished product Specifications USP
Pack size & Demanded Price 100ml/ decontroled
Me-too status (with strength and dosage
form)
Gentasel-10 Injection of M/s Selmore Pharmaceuticals Pvt Ltd,
(Reg.# 034594)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved.
4. Name and address of manufacturer /
Applicant
M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road Humak, Islamabad 45700.
Brand Name +Dosage Form+ Strength Genta XL Forte Injection
Composition Each ml Injection contains:
Gentamicin Sulphate…….110 mg"
Diary No. Date of R& I & fee Dy. No 32407 dated 31-01-2020 Rs. 20,000/- 18-12-2019
Pharmacological Group Antibacterial/Antibiotic
Type of Form Form-5
Finished product Specifications USP
Pack size & Demanded Price 100ml/ Decontrolled
Me-too status (with strength and dosage
form)
Hi-Gent Injection of M/s Selmore Pharma (Reg.# 046517)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved.
5. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282
Industrial Triangle, Kahuta Road Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength T-Gent XL Injection
Composition Each ml Injection contains:
Tylosin Tartrate …….100 mg
Gentamicin………….50mg
Diary No. Date of R& I & fee Dy. No 32409 dated 31-01-2020 Rs. 20,000/- 18-12-2019
Pharmacological Group Antibacterial
Type of Form Form-5
Finished product Specifications Mfg specs
Pack size & Demanded Price 100ml / Decontrolled
Me-too status (with strength and dosage
form)
Tygent Injection of M/s Selmore Pharmaceuticals Pvt Ltd,
(Reg.# 049636)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
Liquid Antibiotic Injectable Section-2 (VET)
Number of products: 08
Number of molecules: 05
6. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road Humak, Islamabad 45700"
Brand Name +Dosage Form + Strength Coliexcel Forte Injection
Composition Each ml Injection contains:
Colistin Sulphate…….500,000 IU
Diary No. Date of R& I & fee Dy. No 32410 dated 31-01-2020 Rs. 20,000/- 18-12-2019
Pharmacological Group Antibacterial
Type of Form Form-5
Finished product Specifications Mfg specs
Minutes of 294th Meeting of Registration Board | 47
Pack size & Demanded Price 100ml/ Decontrolled
Me-too status Coliforte Injection of M/s Selmore Pharma (Reg.# 071086)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
7. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength Coliexcel Injection
Composition Each 100ml Injection contains:
Colistin Sulphate…….20M IU
Diary No. Date of R& I & fee Dy. No 32411 dated 31-01-2020 Rs. 20,000/- 18-12-2019
Pharmacological Group Antibacterial/Antibiotic
Type of Form Form-5
Finished product Specifications Mfg specs
Pack size & Demanded Price 100ml / Decontrolled
Me-too status (with strength and dosage
form)
Colisel Injection of M/s Selmore Pharmaceuticals Pvt Ltd,
(Reg.# 043535)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
8. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength Marbo XL 10 Injection
Composition Each ml contains:
Marbofloxacin…….100mg
Diary No. Date of R& I & fee Dy. No 32408 dated 31-01-2020 Rs. 20,000/- 18-12-2019
Pharmacological Group Antibacterial
Type of Form Form-5
Finished product Specifications Mfg specs
Pack size & Demanded Price 100ml / Decontrolled
Me-too status (with strength and dosage
form)
Marboflox Injection of M/s Selmore Pharmaceuticals Pvt Ltd,
(Reg.# 088088)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
9. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength Oxy XL 5 Injection
Composition Each ml contains:
Oxytetracycline…….50mg
Diary No. Date of R& I & fee Dy. No 32412 dated 31-01-2020 Rs. 20,000/- 18-12-2019
Pharmacological Group Antibacterial/Antibiotic
Type of Form Form-5
Finished product Specifications USP
Pack size & Demanded Price 50ml/ Decontrolled
Me-too status (with strength and dosage
form)
B.G Oxy-50 Injection of M/s Biogen Pharma, (Reg.# 072698)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved.
Minutes of 294th Meeting of Registration Board | 48
10. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength Oxy XL LA Injection
Composition Each 100ml contains:
Oxytetracycline…….20gm
Diary No. Date of R& I & fee Dy. No 32413 dated 31-01-2020 Rs. 20,000/- 18-12-2019
Pharmacological Group Antibacterial
Type of Form Form-5
Finished product Specifications USP
Pack size & Demanded Price 100ml / Decontrolled
Me-too status (with strength and dosage
form)
Oxy-La Injection of M/s Selmore Pharmaceuticals Pvt Ltd,
(Reg.# 035014)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved.
11. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength Oxy XL PVP Injection
Composition Each ml contains:
Oxytetracycline HCl…….100mg
Diary No. Date of R& I & fee Dy. No 32414 dated 31-01-2020 Rs. 20,000/- 18-12-2019
Pharmacological Group Antibacterial/ Antibiotic
Type of Form Form-5
Finished product Specifications Mfg specs
Pack size & Demanded Price 100ml / Decontrolled
Me-too status (with strength and dosage
form)
B.G Oxy-100 Injection of M/s Biogen Pharma (Reg.# 075615)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
12. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength Tetrafen LA Injection
Composition Each ml Injection contains:
Oxytetracycline…….200mg
Ketoprofen…………30mg
Diary No. Date of R& I & fee Dy. No 32415 dated 31-01-2020 Rs. 20,000/- 18-12-2019
Pharmacological Group Antibacterial/NSAID
Type of Form Form-5
Finished product Specifications Mfg specs
Pack size & Demanded Price 100ml / Decontrolled
Me-too status (with strength and dosage
form)
Oxyfen La Injection of M/s Selmore Pharmaceuticals Pvt Ltd,
(Reg.# 071091)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Registration Board referred the case to expert working group on veterinary drugs for
review of formulation.
13. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength Tylo XL 20 Injection
Minutes of 294th Meeting of Registration Board | 49
Composition Each ml Injection contains:
Tylosin Tartrate…….200mg
Diary No. Date of R& I & fee Dy. No 32416 dated 31-01-2020 Rs. 20,000/- 18-12-2019
Pharmacological Group Antibacterial/Antibiotic
Type of Form Form-5
Finished product Specifications Mfg specs
Pack size & Demanded Price 100ml / Decontrolled
Me-too status (with strength and dosage
form)
Tylosel Injection of M/s Selmore Pharmaceuticals Pvt Ltd,
(Reg.# 043534)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
General Injectable Section (Vet)
Number of products: 01
Number of molecules: 01
14. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength Atrowin Injection 1mg
Composition Each ml contains:
Atropine Sulphate…….1mg
Diary No. Date of R& I & fee Dy. No 32417 dated 31-01-2020 Rs. 20,000/- 18-12-2019
Pharmacological Group Antimuscarinic
Type of Form Form-5
Finished product Specifications USP
Pack size & Demanded Price 50ml/ Decontrolled
Me-too status (with strength and dosage
form)
Atrovet Injection of M/s Selmore Pharmaceuticals Pvt Ltd,
(Reg.# 034577)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved.
Penicillin Powder Injectable Section (Vet)
Number of products: 04
Number of molecules: 03
15. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength Penstop 2.5 GM Injection
Composition Each Dry Powder Vial contains:
Benzyl Penicillin………….500,000 IU
Procaine Penicillin………..1,500,000 IU
Streptomycin Sulphate……2.5gm
Diary No. Date of R& I & fee Dy. No 32418 dated 31-01-2020 Rs. 20,000/- 18-12-2019
Pharmacological Group Antibacterial/Antibiotic
Type of Form Form-5
Finished product Specifications Mfg specs
Pack size & Demanded Price 1’s, Decontrolled
Me-too status (with strength and dosage
form)
Biopen 2.5 GM Injection of M/s Selmore Pharmaceuticals Pvt
Ltd, (Reg.# 081717)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
Minutes of 294th Meeting of Registration Board | 50
16. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength Penstop 5 GM Injection
Composition Each Dry Powder Vial contains:
Benzyl Penicillin…….500,000 IU
Procaine Penicillin…….1,500,000 IU
Streptomycin Sulphate……5gm
Diary No. Date of R& I & fee Dy. No 32419 dated 31-01-2020 Rs. 20,000/- 18-12-2019
Pharmacological Group Antibacterial/Antibiotic
Type of Form Form-5
Finished product Specifications Mfg specs
Pack size & Demanded Price 1’s Decontrolled
Me-too status (with strength and dosage
form)
Biopen 5 GM Injection of M/s Selmore Pharmaceuticals Pvt Ltd,
(Reg.# 081718)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
17. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength Penstop Forte Injection
Composition Each Dry Powder Vial contains:
Penicillin G Procaine……………..3,000,000 IU
Penicillin G Sodium……………….1,000,000 IU
Dihydrostreptomycin Sulphate……5 gm
Diary No. Date of R& I & fee Dy. No 32420 dated 31-01-2020 Rs. 20,000/- 18-12-2019
Pharmacological Group Antibacterial/Antibiotic
Type of Form Form-5
Finished product Specifications Mfg specs
Pack size & Demanded Price 1’s / Decontrolled
Me-too status (with strength and dosage
form)
PG-Vet Injection of M/s Selmore Pharmaceuticals Pvt Ltd,
(Reg.# 080957)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
18. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength Penstop 40 Dry Powder Injection
Composition Each Dry Powder Vial contains:
Benzyl Penicillin…..….1,000,000 IU
Procaine Penicillin…….3,000,000 IU
Diary No. Date of R& I & fee Dy. No 32421 dated 31-01-2020 Rs. 20,000/- 18-12-2019
Pharmacological Group Antibacterial/Antibiotic
Type of Form Form-5
Finished product Specifications Mfg specs
Pack size & Demanded Price 1’s / Decontrolled
Me-too status (with strength and dosage
form)
Penisel-40 Dry Powder Injection of M/s Selmore
Pharmaceuticals Pvt Ltd, (Reg.# 080956)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
Minutes of 294th Meeting of Registration Board | 51
Penicillin Liquid Injectable Section (Vet)
Number of Products: 05
Number of Molecules: 05
19. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength Clamoxel Injection 140mg/35mg
Composition Each ml contains:
Amoxicillin as Trihydrate…….140mg
Clavulanic Acid……………….35mg
Diary No. Date of R& I & fee Dy. No 32422 dated 31-01-2020 Rs. 20,000/- 18-12-2019
Pharmacological Group Antibacterial/Antibiotic
Type of Form Form-5
Finished product Specifications Mfg specs
Pack size & Demanded Price 100ml / Decontrolled
Me-too status (with strength and dosage
form)
Clavet Injection of M/s Selmore Pharmaceuticals Pvt Ltd, (Reg.#
046519)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
20. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength Moxigent XL Injection 50mg/25mg
Composition Each ml contains:
Amoxicillin Trihydrate eq. to Amoxicillin…….50mg
Gentamicin Sulphate eq. to Gentamicin……….25mg
Diary No. Date of R& I & fee Dy. No 32423 dated 31-01-2020 Rs. 20,000/- 18-12-2019
Pharmacological Group Antibacterial/Antibiotic
Type of Form Form-5
Finished product Specifications Innovator’s Specification
Pack size & Demanded Price 100ml / Decontrolled
Me-too status (with strength and dosage
form)
Amoxygent Injection of M/s Selmore Pharmaceuticals Pvt Ltd,
(Reg.# 080953)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
21. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength Moxivet LA Injection
Composition "Each ml contains:
Amoxicillin as Trihydrate …….150 mg"
Diary No. Date of R& I & fee Dy. No 32424 dated 31-01-2020 Rs. 20,000/- 18-12-2019
Pharmacological Group Antibacterial/Antibiotic
Type of Form Form-5
Finished product Specifications Mfg specs
Pack size & Demanded Price 100ml / Decontrolled
Me-too status (with strength and dosage
form)
Novamox LA Injection of M/s Selmore Pharmaceuticals Pvt Ltd,
(Reg.# 043135)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
Minutes of 294th Meeting of Registration Board | 52
22. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength Moxstil Injection
Composition Each ml contains:
Amoxicillin as Trihydrate…….100mg
Colistin Sulphate…………..….250,000 IU
Diary No. Date of R& I & fee Dy. No 32425 dated 31-01-2020 Rs. 20,000/- 18-12-2019
Pharmacological Group Antibacterial/Antibiotic
Type of Form Form-5
Finished product Specifications Mfg specs
Pack size & Demanded Price 100ml / Decontrolled
Me-too status (with strength and dosage
form)
Colimoxin Injection of M/s Selmore Pharmaceuticals Pvt Ltd,
(Reg.# 034576)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
23. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength Panidex Liquid Injection
Composition Each ml contains:
Benzyl Penicillin Procaine….…………125,000IU
Benzathine Penicillin G………………..125,000IU
Dihydrostreptomycin Sulphate…………0.25 gm
Dexamethasone Sodium Phosphate…….0.20 mg
Dexamethasone-21-Isonicotinate……….0.20 mg
Diary No. Date of R& I & fee Dy. No 32426 dated 31-01-2020 Rs. 20,000/- 18-12-2019
Pharmacological Group Antibacterial/Steroid
Type of Form Form-5
Finished product Specifications Mfg specs
Pack size & Demanded Price 50ml/ Decontrolled
Me-too status (with strength and dosage
form)
BDEX Liquid Injection of M/s Selmore Pharmaceuticals Pvt Ltd,
(Reg.# 080952)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator The firm has been granted with New Steroid Injectable Section
(Vet) as well.
Decision: Registration Board referred the case to expert working group on veterinary drugs for
review of formulation.
Penicillin Oral Powder Section (Vet)
Number of products: 07
Number of molecules: 04
24. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength Medi PSZ Oral Powder
Composition Each kg contains:
Procaine Penicillin………...12 gm
Streptomycin Sulphate…….36 gm
Zinc Bacitracin 10%............52 gm
Diary No. Date of R& I & fee Dy. No 32427 dated 31-01-2020 Rs. 20,000/- 18-12-2019
Pharmacological Group Antibacterial/
Type of Form Form-5
Finished product Specifications Mfg specs
Pack size & Demanded Price 1kg, 5kg / Decontrolled
Minutes of 294th Meeting of Registration Board | 53
Me-too status (with strength and dosage
form)
Probac Oral Powder of M/s Selmore Pharmaceuticals Pvt Ltd,
(Reg.# 088099)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
25. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength Pro PSZ Powder
Composition Each kg contains:
Procain Penicillin………….12 gm
Streptomycin Sulphate…….36 gm
Colistin Sulphate……….….60 MIU
Zinc Bacitracin 10%.............52 gm
Diary No. Date of R& I & fee Dy. No 32428 dated 31-01-2020 Rs. 20,000/- 18-12-2019
Pharmacological Group Antibacterial
Type of Form Form-5
Finished product Specifications Mfg specs
Pack size & Demanded Price 500gm, 1000gm, 2.5kg, 5kg/ Decontrolled
Me-too status (with strength and dosage
form)
Zeptocol Powder of M/s Selmore Pharmaceuticals Pvt Ltd,
(Reg.# 080962)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
26. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road, Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength Clamo XL Forte Oral Powder
Composition Each 100gm Powder contains:
Amoxicillin as Amoxicillin Trihydrate……..…16 gm
Clavulanic Acid as Potassium Clavulanate…….4gm
Bromhexine Hydrochloride…………………….0.5gm
Diary No. Date of R& I & fee Dy. No 226 dated 04-02-2020 Rs. 20,000/- 30-12-2019
Pharmacological Group Antibacterial / Expectorant
Type of Form Form-5
Finished product Specifications Mfg specs
Pack size & Demanded Price 100gm, 250gm, 500gm, 1000gm & 5Kg / Decontrolled
Me-too status (with strength and dosage
form)
Clavicillin Plus Oral Powder of M/s Vetz Pharmaceuticals Pvt
Ltd, (Reg.# 085486)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
27. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road, Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength Moxi Kol 10 Powder Oral
Composition Each gm Powder contains:
Amoxicillin………….100 mg
Colistin Sulphate…….500,000 IU
Diary No. Date of R& I & fee Dy. No 227 dated 04-02-2020 Rs. 20,000/- 30-12-2019
Pharmacological Group Antibacterial
Type of Form Form-5
Finished product Specifications Mfg specs
Pack size & Demanded Price 100gm, 250gm, 500gm, 1000gm / Decontrolled
Minutes of 294th Meeting of Registration Board | 54
Me-too status (with strength and dosage
form)
Colimoxin Powder of M/s Selmore Pharmaceuticals Pvt Ltd,
(Reg.# 034583)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
28. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road, Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength Moxi Kol 15 Water Soluble Powder Oral
Composition Each 100gm Powder contains:
Amoxycillin Trihydrate equivalent to amoxycillin…….15gm
Colistin Sulphate…….50MIU
Diary No. Date of R& I & fee Dy. No 228 dated 04-02-2020 Rs. 20,000/- 30-12-2019
Pharmacological Group Antibacterial
Type of Form Form-5
Finished product Specifications Mfg specs
Pack size & Demanded Price 100gm, 250gm, 500gm, 1000gm / Decontrolled
Me-too status (with strength and dosage
form)
Vety Moxil C Water Soluble Powder of M/s Leads
Pharmaceuticals Pvt Ltd, (Reg.# 019933)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
29. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road, Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength Moxi Kol 20 Oral Dry Powder
Composition Each 100gm Powder contains:
Amoxicillin Trihydrate…….20gm
Colistin Sulphate…….80 MIU
Diary No. Date of R& I & fee Dy. No 229 dated 04-02-2020 Rs. 20,000/- 30-12-2019
Pharmacological Group Antibacterial
Type of Form Form-5
Finished product Specifications Mfg specs
Pack size & Demanded Price 100gm, 250gm, 500gm, 1000gm / Decontrolled
Me-too status (with strength and dosage
form)
Colimoxin Forte Oral Dry Powder of M/s Selmore
Pharmaceuticals Pvt Ltd, (Reg.# 080961)
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
30. Name and address of manufacturer /
Applicant
"M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282 Industrial
Triangle, Kahuta Road, Humak, Islamabad 45700"
Brand Name +Dosage Form+ Strength Moxi Kol Forte Oral Water Soluble Powder
Composition Each 100gm Powder contains:
Amoxicillin Trihydrate…….50gm
Colistin Sulphate…………..50 MIU
Diary No. Date of R& I & fee Dy. No 230 dated 04-02-2020 Rs. 20,000/- 30-12-2019
Pharmacological Group Antibacterial
Type of Form Form-5
Finished product Specifications Mfg specs
Pack size & Demanded Price 100gm, 250gm, 500gm, 1000gm / Decontrolled
Me-too status (with strength and dosage
form)
ATC-Forte Oral Water Soluble Powder of M/s Sanna
Laboratories, (Reg.# 081695)
Minutes of 294th Meeting of Registration Board | 55
GMP status GMP certificate issued on the basis of inspection conducted on
08/10/2019.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
M/s Evergreen Pharmaceuticals, Lahore was granted New Liquid Injection (General) Section (Veterinary
vide letter NO.F.1-31/2010-Lic (Vol I) dated 13/02/2020. The firm has applied the following products
against the approved section.
Liquid Injection (General) Section (Veterinary)
Number of products: 11
Number of Molecules: 10
31. Name and address of manufacturer /
Applicant
M/s Evergreen Pharmaceuticals, 69-70/B, Main Glaxo Town,
Industrial Area,20th Km Ferozpur Road, Lahore
Brand Name +Dosage Form+Strength Flomax 300mg Injection
Composition Each ml Contains:
Florfenicol……………..………..300MG
Diary No. Date of R& I & fee Dy. No.32321 Dated 30-1-2020, RS 20,000/-
Pharmacological Group Anti-Biotics
Type of Form Form-5
Finished product Specifications Manufacturer's Specifications
Pack size & Demanded Price 50ml / Decontrolled
Me-too status (with strength and
dosage form)
Rivaflor 300 Injection by M/s Mylab Pharma, Reg . no. 78205
GMP status New Section
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
32. Name and address of manufacturer /
Applicant
M/s Evergreen Pharmaceuticals, 69-70/B, Main Glaxo Town,
Industrial Area,20th Km Ferozpur Road, Lahore
Brand Name +Dosage Form+Strength Enrocol-20 Injection
Composition Each ml contains:-
Enrofloxacin ………………. 200mg
Diary No. Date of R& I & fee Dy. No. 32320 Dated 30-1-2020, RS 20,000/-
Pharmacological Group Anti-Biotic
Type of Form Form-5
Finished product Specifications Manufacturer's Specifications
Pack size & Demanded Price 100ml / Decontrolled
Me-too status (with strength and
dosage form)
Enflox-20 injection by M/s SJG Fazal Elahi, Reg. No. 048153
GMP status New section
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
33. Name and address of manufacturer /
Applicant
M/s Evergreen Pharmaceuticals, 69-70/B, Main Glaxo Town,
Industrial Area,20th Km Ferozpur Road, Lahore
Brand Name+Dosage Form+ Strength Enrocol-10 Injection
Composition Each ml contains:-
Enrofloxacin ………………. 100mg
Diary No. Date of R& I & fee Dy. No. 21635 Dated 23/10/2019, RS 20,000/-
Pharmacological Group Anti-Biotic
Type of Form Form-5
Finished product Specifications Manufacturer's Specifications
Pack size & Demanded Price 100ml / Decontrolled
Me-too status Enrosal Injection by M/s Zakfas Pharma, Reg. No. 046658
GMP status New Section
Minutes of 294th Meeting of Registration Board | 56
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
34. Name and address of manufacturer /
Applicant
M/s Evergreen Pharmaceuticals, 69-70/B, Main Glaxo Town,
Industrial Area,20th Km Ferozpur Road, Lahore
Brand Name+Dosage Form+ Strength Evermec 10mg Injection
Composition Each ml contains:-
Ivermectin………..10mg
Diary No. Date of R& I & fee Dy. No. 21638 Dated 23/10/2019, RS 20,000/-
Pharmacological Group Anthelminitic
Type of Form Form-5
Finished product Specifications USP
Pack size & Demanded Price 50ml / Decontrolled
Me-too status (with strength and
dosage form)
Alfamec 1% Injection by M/s Alina Pharma, Reg. No. 048180
GMP status New Section
Remarks of the Evaluator
Decision: Approved.
35. Name and address of manufacturer /
Applicant
M/s Evergreen Pharmaceuticals, 69-70/B, Main Glaxo Town,
Industrial Area,20th Km Ferozpur Road, Lahore
Brand Name+Dosage Form+ Strength V-12 250mcg Injection
Composition Each ml contains:-
Cyanacobalamin……….. 250mcg
Diary No. Date of R& I & fee Dy. No. 21642 Dated 23/10/2019, RS 20,000/-
Pharmacological Group Vitamin
Type of Form Form-5
Finished product Specifications Manufacturer's Specifications
Pack size & Demanded Price 100ml / Decontrolled
Me-too status (with strength and
dosage form)
Cynosel Injection by M/s Selmore Pharma, Reg. No. 94483
GMP status New Section
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
36. Name and address of manufacturer /
Applicant
M/s Evergreen Pharmaceuticals, 69-70/B, Main Glaxo Town,
Industrial Area,20th Km Ferozpur Road, Lahore
Brand Name+Dosage Form+ Strength Oxytec Injection 300mg/20mg
Composition Each ml contains:-
Oxytetracycline as dihydrate………... 300mg
Flunixin meglumine…………..…...... 20Mmg
Diary No. Date of R& I & fee Dy. No. 21640 Dated 23/10/2019, RS 20,000/-
Pharmacological Group Anti-biotic, Anti inflammatory
Type of Form Form-5
Finished product Specifications Manufacturer's Specifications
Pack size & Demanded Price 50ml / Decontrolled
Me-too status (with strength and
dosage form)
Floxy Injection by M/s Alina Combine Pharma,, Reg. No.
048288
GMP status New Section
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
37. Name and address of manufacturer /
Applicant
M/s Evergreen Pharmaceuticals, 69-70/B, Main Glaxo Town,
Industrial Area,20th Km Ferozpur Road, Lahore
Brand Name +Dosage Form+Strength Meloxi-G Injection 10mg
Composition Each ml contains:-
Meloxicam………10mg
Diary No. Date of R& I & fee Dy. No. 21641 Dated 23/10/2019, RS 20,000/-
Minutes of 294th Meeting of Registration Board | 57
Pharmacological Group Anti inflammatory
Type of Form Form-5
Finished product Specifications Manufacturer's Specifications
Pack size & Demanded Price 100ml / Decontrolled
Me-too status (with strength and
dosage form)
Loxicon Injection by M/s Vecton Pharma, Reg. No. 057187
GMP status New Section
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
38. Name and address of manufacturer /
Applicant
M/s Evergreen Pharmaceuticals, 69-70/B, Main Glaxo Town,
Industrial Area,20th Km Ferozpur Road, Lahore
Brand Name +Dosage Form+Strength E-SULPHA Injection 333mg
Composition Each ml contains:-
Sulphadimidine sodium……..333mg
Diary No. Date of R& I & fee Dy. No. 21639 Dated 23/10/2019, RS 20,000/-
Pharmacological Group Anti-biotic
Type of Form Form-5
Finished product Specifications Manufacturer's Specifications
Pack size & Demanded Price 100ml / Decontrolled
Me-too status (with strength and
dosage form)
Could not be confirmed
GMP status New Section
Remarks of the Evaluator
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic
/ me-too status) alongwith registration number, brand name and name of firm.
39. Name and address of manufacturer /
Applicant
M/s Evergreen Pharmaceuticals, 69-70/B, Main Glaxo Town,
Industrial Area,20th Km Ferozpur Road, Lahore
Brand Name +Dosage Form+Strength OXY-G Injection 50mg
Composition Each ml contains:-
Oxytetracycline .….…..50mg
Diary No. Date of R& I & fee Dy. No. 21634 Dated 23/10/2019, RS 20,000/-
Pharmacological Group Anti-biotic
Type of Form Form-5
Finished product Specifications USP
Pack size & Demanded Price 100ml / Decontrolled
Me-too status (with strength and
dosage form)
Emivet-5 Injection by M/s Zakfas Pharma, Reg.No. 046543
GMP status New Section
Remarks of the Evaluator
Decision: Approved.
40. Name and address of manufacturer /
Applicant
M/s Evergreen Pharmaceuticals, 69-70/B, Main Glaxo Town,
Industrial Area,20th Km Ferozpur Road, Lahore
Brand Name+Dosage Form+Strength E-GENTA Injection 100mg
Composition Each ml contains:-
Gentamicin Sulphate …….100mg
Diary No. Date of R& I & fee Dy. No. 21636 Dated 23/10/2019, RS 20,000/-
Pharmacological Group Anti-biotic
Type of Form Form-5
Finished product Specifications USP
Pack size & Demanded Price 100ml / Decontrolled
Me-too status Genta-10% Injection by M/s Symans Pharma, R.No. 046547
GMP status New Section
Remarks of the Evaluator
Decision: Approved.
Minutes of 294th Meeting of Registration Board | 58
41. Name and address of manufacturer /
Applicant
M/s Evergreen Pharmaceuticals, 69-70/B, Main Glaxo Town,
Industrial Area,20th Km Ferozpur Road, Lahore
Brand Name+Dosage Form+ Strength TYLO-G Injection 50mg/100mg
Composition Each ml contains:-
Gentamicin (as sulphate)……………....50mg
Tylosin (as tartrate)………………..…..100mg
Diary No. Date of R& I & fee Dy. No. 21634 Dated 23/10/2019, RS 20,000/-
Pharmacological Group Anti-biotic
Type of Form Form-5
Finished product Specifications Manufacturer's Specifications
Pack size & Demanded Price 100ml / Decontrolled
Me-too status (with strength and
dosage form)
Genta-Tylosin Injection by M/s International Chempharma,
Reg. No. 31514
GMP status New Section
Remarks of the Evaluator
Decision: Approved.
M/s Vetz Pharmaceutical (Pvt) Ltd, Plot No. Q-1, S.I.T.E Kotri Sindh was granted Aerosol Spray
(Veterinary) Section vide letter No. F.2-8/2011-Lic dated 5th November, 2019. The firm has
applied following products against the approved section.
Aerosol Spray (veterinary) Section\
Number of products: 06
Number of molecules: 06
42.
Name and address of Manufacturer /
Applicant
M/s Vetz Pharmaceutical (Pvt) Ltd Plot # Q-1, S.I.T.E, Kotri,
Sindh
Brand Name +DosageForm+Strength Oxygent Aerosol Spray
Composition Each ml contains:
Oxytetracycline HCl……..40 mg
Gentian Violet..…..………4 mg
Permetrin ………………. 10 mg
Citronella oil …………… 20 mg
Diary No. Date of R & I & fee Dy No. 24326 dated 19/11/2019 Rs. 20,000
Pharmacological Group Antibacterial
Types of Form Form-5
Finished Product Specification Vetz Specs
Pack Size & Demanded Price 100 ml, 125 ml, 150 ml, 200 ml, 250 ml, 300 ml / Decontrolled
Me-too status Tetragent Plus By M/s Star Labs, Reg No. 63623
GMP status 26 & 27-7-2019
Conclusion: Based on the above observation their current GMP
compliance level is rated as good.
Remarks of Evaluator
Decision: Approved with innovator’s specification.
43. Name and address of Manufacturer /
Applicant
M/s Vetz Pharmaceutical (Pvt) Ltd Plot # Q-1, S.I.T.E, Kotri,
Sindh
Brand Name +DosageForm+Strength Teravetz Aerosol Spray
Composition Each gm contains:
Oxytetracycline HCl…..40 mg
Gentian Violet..…..……4 mg
Diary No. Date of R & I & fee Dy No. 24328 dated 19/11/2019 Rs. 20,000
Pharmacological Group Antibacterial
Types of Form Form-5
Finished Product Specification Vetz Specs
Pack Size & Demanded Price 100 ml, 125 ml, 150 ml, 200 ml, 250 ml, 300 ml
Decontrolled
Minutes of 294th Meeting of Registration Board | 59
Me-too status Could not be verified
GMP status 26 & 27-7-2019. Conclusion: Based on the above observation their
current GMP compliance level is rated as good.
Remarks of Evaluator Me too status vcould not be verified.
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic /
me-too status) alongwith registration number, brand name and name of firm.
44. Name and address of Manufacturer /
Applicant
M/s Vetz Pharmaceutical (Pvt) Ltd Plot # Q-1, S.I.T.E, Kotri,
Sindh
Brand Name +DosageForm+Strength Vetasone Aerosol Spray
Composition() Each ml contains:
Oxytetracycline HCl…..5mg
Hdrocortisone..…..……1.6mg
Diary No. Date of R & I & fee Dy No. 24331 dated 19/11/2019; Rs. 20,000
Pharmacological Group Antibacterial, corticosteroid
Types of Form Form-5
Finished Product Specification Vetz Specs
Pack Size & Demanded Price 100 ml, 125 ml, 150 ml, 200 ml, 250 ml, 300 ml
Decontrolled
Me-too status Cortisel Spray By M/s Selmore, Reg. No. 071079
GMP status 26 & 27-7-2019
Conclusion: Based on the above observation their current GMP
compliance level is rated as good.
Remarks of Evaluator
Decision: Approved with innovator’s specification.
45. Name and address of Manufacturer /
Applicant
M/s Vetz Pharmaceutical (Pvt) Ltd., Plot#Q-1, S.I.T.E, Kotri,
Sindh
Brand Name +DosageForm+Strength Teravetz 2.5 % Aerosol Spray
Composition Each ml contains:
Oxytetracycline …..…..25 mg
Gentian Violet..…..……5 mg
Diary No. Date of R & I & fee Dy No. 24327 dated 19/11/2019 Rs. 20,000
Pharmacological Group Antibacterial
Types of Form Form-5
Finished Product Specification Vetz Specs
Pack Size & Demanded Price 100 ml, 125 ml, 150 ml, 200 ml, 250 ml, 300 ml
Decontrolled
Me-too status Teragen 2.5% Aerosol Spray of M/s Star Labs, R.No.043300
GMP status 26 & 27-7-2019. Conclusion: Based on the above observation their
current GMP compliance level is rated as good.
Remarks of Evaluator
Decision: Approved with innovator’s specification.
46. Name and address of Manufacturer /
Applicant
M/s Vetz Pharmaceutical (Pvt) Ltd Plot # Q-1, S.I.T.E, Kotri,
Sindh
Brand Name +DosageForm+Strength Clorvetz Aerosol Spray
Composition() Each 200 ml contains:
Chloramphenicol…..…..3.25 gm
Nitrofurazone ………….0.15 gm
Gentian Violet..…..……0.15 gm
Diary No. Date of R & I & fee Dy No. 24329 dated 19/11/2019 ; Rs. 20,000
Pharmacological Group Antibacterial / antiseptic
Types of Form Form-5
Finished Product Specification Vetz Specs
Pack Size & Demanded Price 100 ml, 125 ml, 150 ml, 200 ml, 250 ml, 300 ml
Decontrolled
Minutes of 294th Meeting of Registration Board | 60
Me-too status Clonigent Spray By M/s Star Labs, Reg. No. 023419
GMP status 26 & 27-7-2019. Conclusion: Based on the above observation their
current GMP compliance level is rated as good.
Remarks of Evaluator
Decision: Registration Board referred the case to expert working group on veterinary drugs for
review of formulation.
47. Name and address of Manufacturer /
Applicant
M/s Vetz Pharmaceutical (Pvt) Ltd Plot # Q-1, S.I.T.E, Kotri,
Sindh
Brand Name +DosageForm+Strength Oxyvetz Aerosol Spray
Composition() Each 300 ml contains:
Oxytetracycline HCl ………………1500 mg
Diary No. Date of R & I & fee Dy No. 24330 dated 19/11/2019 Rs. 20,000
Pharmacological Group Diuretic
Types of Form Form-5
Finished Product Specification Vetz Specs
Pack Size & Demanded Price 100 ml, 125 ml, 150 ml, 200 ml, 250 ml, 300 ml
Decontrolled
Me-too status Oxycort spray By M/s Star Labs, Reg. No. 014143
GMP status 26 & 27-7-2019
Conclusion : Based on the above observation their current GMP
compliance level is rated as good.
Remarks of Evaluator
Decision: Approved with innovator’s specification.
Item No. 3: Agenda of Evaluator PEC-II
Case no. 01 Registration applications for local manufacturing of (Human) drugs
a. New cases
b. Deferred cases
Case no. 02 Registration applications of newly granted DML or New section (Human)
a. New DML
b. New/Additional section(s)
Central Licensing Board in its 270th meeting held on 23rd MAY, 2019 has considered and approved the
following 4 additional section of firm M/s Arreta Pharmaceuticals Pvt. Ltd. Plot No. 13, Street N-5, RCCI,
Industrial Estate, Rawalpindi. Accordingly the Secretary CLB has issued letter for grant of additional section
dated 27th June, 2019.
In 291st meeting below mentioned products have been considered on priority against new sections as detailed
below:
Sr. No Section Previously considered applications
Molecules Products
01 Sterile Dry powder for
Injection(Cephalosporin)
4 11
02 Dry powder for suspension
(Cephalosporin)
3 3
03 Capsule Section Cephalosporin 1 1
Now the remaining applications of the firm have been retrieved, which were applied in the same date and are
presented below for priority consideration, against the available balance for priority consideration.
Sterile Dry Powder for Injection (Cephalosporin)
2 Molecules/ 09 Products
48. Name and address of manufacturer /
Applicant
M/s Arreta Pharmaceuticals Pvt Ltd. Plot No. 13, Street N-5,
RCCI, Industrial Estate, Rawalpindi
Brand Name +Dosage Form + Strength C-Tri 1g IV Injection
Composition "Each Vial Contains:
Ceftriaxone Sodium Eq. to Ceftriaxone…1000mg"
Minutes of 294th Meeting of Registration Board | 61
Diary No. Date of R& I & fee Dy.No.13383 dated 07-03-2019 Rs20,000/- (07-3-2019)
Pharmacological Group Antibiotic
Type of Form Form 5
Finished Product Specification USP
Pack Size & Demanded Price As per SRO
Approval Status of Product in
Reference Regulatory Authorities
Approved by USFDA
Me-too Status Rezone 1gm Injection IV by M/s Well Care
Pharmaceuticals, Islamabad. (Reg.#031980)
GMP Status Central Licensing Board in its 270th meeting held on 23rd
MAY, 2019 has approved additional section
Remarks of the Evaluator. The molecule has already been considered for Sterile Dry
Powder for Injection (Cephalosporin) in 291st meeting
Decision: Approved.
49. Name and address of manufacturer /
Applicant
M/s Arreta Pharmaceuticals Pvt Ltd. Plot No. 13, Street N-5,
RCCI, Industrial Estate, Rawalpindi
Brand Name+Dosage Form+Strength Alzone 500mg/500mg Injection
Composition "Each Vial Contains:
Cefoperazone as Sodium …… 500mg
Sulbactam as Sodium ….… 500mg"
Diary No. Date of R& I & fee Dy. No 13392 dated 07-03-2019 Rs20,000/- (07-03-2019)
Pharmacological Group Antibiotic
Type of Form Form-5
Finished Product Specification JP
Pack Size & Demanded Price As per SRO
Approval Status of Product in
Reference Regulatory Authorities
Approved by PMDA-Japan
Me-too Status 2Sum Injection 1g of M/s Sami
Pharmaceuticals(R.#047002)
GMP Status Central Licensing Board in its 270th meeting held on 23rd
MAY, 2019 has approved additional section
Remarks of the Evaluator. The molecule has already been considered for Sterile Dry
Powder for Injection (Cephalosporin) in 291st meeting
Decision: Approved.
50. Name and address of manufacturer /
Applicant
M/s Arreta Pharmaceuticals Pvt Ltd. Plot No. 13, Street N-5,
RCCI, Industrial Estate, Rawalpindi
Brand Name+Dosage Form+Strength Arretaz 1g Injection
Composition "Each Vial Contains:
Ceftazidime Pentahydrate with L-Arginine eq. to
Ceftazidime ….…1gm"
Diary No. Date of R& I & fee Dy. No 13406 dated 07-03-2019 Rs20,000/- (07-03-2019)
Pharmacological Group Antibacterial
Type of Form Form-5
Finished Product Specification USP
Pack Size & Demanded Price As per SRO
Approval Status of Product in
Reference Regulatory Authorities
Approved by MHRA of UK
Me-too Status Cefcom by Barrett Hodgson Pharmaceuticals
GMP Status Central Licensing Board in its 270th meeting held on 23rd
May, 2019 has approved additional section
Remarks of the Evaluator. The molecule has already been considered for Sterile Dry
Powder for Injection (Cephalosporin) in 291st meeting
Decision: Approved.
Minutes of 294th Meeting of Registration Board | 62
51. Name and address of manufacturer /
Applicant
M/s Arreta Pharmaceuticals Pvt Ltd. Plot No. 13, Street N-5,
RCCI, Industrial Estate, Rawalpindi
Brand Name +Dosage Form+Strength Arretaz 250mg Injection
Composition "Each Vial Contains:
Ceftazidime Pentahydrate With L-Arginine eq. to
Ceftazidime…250mg"
Diary No. Date of R& I & fee Dy. No 13404 dated 07-03-2019 Rs20,000/- (07-03-2019)
Pharmacological Group Antibacterial
Type of Form Form-5
Finished Product Specification USP
Pack Size & Demanded Price As per SRO
Approval Status of Product in
Reference Regulatory Authorities
Approved by MHRA of UK
Me-too Status Ceplo Injection 250mg IM/IV of M/s Cirin Parma (Pvt.) Ltd,
(Reg.# 024415)
GMP Status Central Licensing Board in its 270th meeting held on 23rd
May, 2019 has approved additional section
Remarks of the Evaluator. The molecule has already been considered for Sterile Dry
Powder for Injection (Cephalosporin) in 291st meeting
Decision: Approved.
52. Name and address of manufacturer /
Applicant
M/s Arreta Pharmaceuticals Pvt Ltd. Plot No. 13, Street N-5,
RCCI, Industrial Estate, Rawalpindi
Brand Name +Dosage Form+Strength Bestax 250mg Injection
Composition "Each Vial Contains:
Cefotaxime as Sodium…250mg"
Diary No. Date of R& I & fee Dy. No 13408 dated 07-03-2019 Rs20,000/- (07-03-2019)
Pharmacological Group Antibacterial
Type of Form Form-5
Finished Product Specification USP
Pack Size & Demanded Price As per SRO
Approval Status of Product in
Reference Regulatory Authorities
Claforan 250mg Injection by Sanofi Aventis
(Netherland Approved)
Me-too Status Palfotax 250mg Injection M/s Palpex Pharmaceuticals (Pvt)
Ltd, Karachi
GMP Status Central Licensing Board in its 270th meeting held on 23rd
May, 2019 has approved additional section
Remarks of the Evaluator.
Decision: Approved.
53. Name and address of manufacturer /
Applicant
M/s Arreta Pharmaceuticals Pvt Ltd. Plot No. 13, Street N-5,
RCCI, Industrial Estate, Rawalpindi
Brand Name +Dosage Form+Strength Bestax 1g Injection
Composition "Each Vial Contains:
Cefotaxime as Sodium…1gm"
Diary No. Date of R& I & fee Dy. No 13410 dated 07-03-2019 Rs20,000/- (07-03-2019)
Pharmacological Group Antibacterial
Type of Form Form-5
Finished Product Specification USP
Pack Size & Demanded Price As per SRO
Approval Status of Product in
Reference Regulatory Authorities
Approved by USFDA
Me-too Status Getex Dry powder Injection 1gm by M/s Amarant
from Medicaid, Karachi (Reg#080279)
GMP Status Central Licensing Board in its 270th meeting held on 23rd
May, 2019 has approved additional section
Minutes of 294th Meeting of Registration Board | 63
Remarks of the Evaluator.
Decision: Approved.
54. Name and address of manufacturer /
Applicant
M/s Arreta Pharmaceuticals Pvt Ltd. Plot No. 13, Street N-5,
RCCI, Industrial Estate, Rawalpindi
Brand Name +Dosage Form+Strength Arrepim 500mg Injection
Composition "Each Vial Contains:
Cefepime as HCl With L-Arginine Eq. to Cefepime..500mg
Diary No. Date of R& I & fee Dy. No 13386 dated 07-03-2019 Rs20,000/- (07-03-2019)
Pharmacological Group Antibacterial
Type of Form Form-5
Finished Product Specification USP
Pack Size & Demanded Price As per SRO
Approval Status of Product in
Reference Regulatory Authorities
Approved by USFDA
Me-too Status Feldopim 500mg Injection of M/s Wnsfeild (Reg.#046970)
GMP Status Central Licensing Board in its 270th meeting held on 23rd
May, 2019 has approved additional section
Remarks of the Evaluator.
Decision: Approved.
55. Name and address of manufacturer /
Applicant
M/s Arreta Pharmaceuticals Pvt Ltd. Plot No. 13, Street N-5,
RCCI, Industrial Estate, Rawalpindi
Brand Name +Dosage Form+Strength Arrepim 1g Injection
Composition "Each Vial Contains:
Cefepime as HCl With L-Arginine Eq. to Cefepime…1gm"
Diary No. Date of R& I & fee Dy. No 13380 dated 07-03-2019 Rs20,000/- (07-03-2019)
Pharmacological Group Antibacterial
Type of Form Form-5
Finished Product Specification USP
Pack Size & Demanded Price As per SRO
Approval Status of Product in Reference
Regulatory Authorities
Approved by USFDA
Me-too Status Nuxipim 1g Injection of Bosch
GMP Status Central Licensing Board in its 270th meeting held on 23rd
May, 2019 has approved additional section
Remarks of the Evaluator.
Decision: Approved.
56. Name and address of manufacturer /
Applicant
M/s Arreta Pharmaceuticals Pvt Ltd. Plot No. 13, Street N-5,
RCCI, Industrial Estate, Rawalpindi
Brand Name +Dosage Form+Strength Bestax 500mg Injection
Composition "Each Vial Contains:
Cefotaxime as Sodium…500mg"
Diary No. Date of R& I & fee Dy. No 13409 dated 07-03-2019 Rs20,000/- (07-03-2019)
Pharmacological Group Antibacterial
Type of Form Form-5
Finished Product Specification USP
Pack Size & Demanded Price As per SRO
Approval Status of Product in
Reference Regulatory Authorities
Approved by MHRA of UK
Me-too Status Getex Dry Powder Injection 500mg of M/s Amarant from
Medicaid Karachi (Reg.# 080278)
GMP Status Central Licensing Board in its 270th meeting held on 23rd
May, 2019 has approved additional section
Remarks of the Evaluator.
Decision: Approved.
Minutes of 294th Meeting of Registration Board | 64
Dry powder for suspension (Cephalosporin)
5 molecules/10 products
57. Name and address of manufacturer /
Applicant
M/s Arreta Pharmaceuticals Pvt Ltd. Plot No. 13, Street N-5,
RCCI, Industrial Estate, Rawalpindi
Brand Name +Dosage Form+Strength Arrenir 250mg/5ml Dry Suspension
Composition "Each 5ml After Reconstitution Contains:
Cefdinir…………………………..250mg"
Diary No. Date of R& I & fee Dy. No 13402 dated 07-03-2019 Rs20,000/- (07-03-2019)
Pharmacological Group Antibacterial
Type of Form Form-5
Finished Product Specification USP
Pack Size & Demanded Price As per SRO
Approval Status of Product in Reference
Regulatory Authorities
Approved by USFDA
Me-too Status Zefnir 250mg Dry Powder Suspension of M/s Genome
Pharmaceuticals (Pvt,) Ltd, Hattar. (Reg.# 075526)
GMP Status Central Licensing Board in its 270th meeting held on 23rd
May, 2019 has approved additional section
Remarks of the Evaluator.
Decision: Approved.
58. Name and address of manufacturer /
Applicant
M/s Arreta Pharmaceuticals Pvt Ltd. Plot No. 13, Street N-5,
RCCI, Industrial Estate, Rawalpindi
Brand Name +Dosage Form+Strength Arrenir 125mg/5ml Suspension
Composition "Each 5ml After Reconstitution Contains:
Cefdinir…125mg"
Diary No. Date of R& I & fee Dy. No 13401 dated 07-03-2019 Rs20,000/- (07-03-2019)
Pharmacological Group Antibacterial
Type of Form Form-5
Finished Product Specification USP
Pack Size & Demanded Price As per SRO
Approval Status of Product in Reference
Regulatory Authorities
Approved by USFDA
Me-too Status Zefnir 250mg Dry Powder Suspension of M/s Genome
Pharmaceuticals (Pvt,) Ltd, Hattar. (Reg.# 075525)
GMP Status Central Licensing Board in its 270th meeting held on 23rd
May, 2019 has approved additional section
Remarks of the Evaluator.
Decision: Approved.
59. Name and address of manufacturer /
Applicant
M/s Arreta Pharmaceuticals Pvt Ltd. Plot No. 13, Street N-5,
RCCI, Industrial Estate, Rawalpindi
Brand Name +Dosage Form+Strength Aphrine 250mg/5ml Dry Suspension
Composition "Each 5ml After Reconstitution Contains:
Cephradine Monohydrate Eq. to Cephradine…250mg"
Diary No. Date of R& I & fee Dy. No 13388 dated 07-03-2019 Rs20,000/- (07-03-2019)
Pharmacological Group Antibacterial
Type of Form Form-5
Finished Product Specification USP
Pack Size & Demanded Price As per SRO
Approval Status of Product in Reference
Regulatory Authorities
Approved by MHRA of UK
Me-too Status Licef Dry Powder suspension 250mg/5ml by M/s Wisdom
Pharmaceuticals (Reg#078531)
Minutes of 294th Meeting of Registration Board | 65
GMP Status Central Licensing Board in its 270th meeting held on 23rd
May, 2019 has approved additional section
Remarks of the Evaluator.
Decision: Approved.
60. Name and address of manufacturer /
Applicant
M/s Arreta Pharmaceuticals Pvt Ltd. Plot No. 13, Street N-5,
RCCI, Industrial Estate, Rawalpindi
Brand Name +Dosage Form+Strength Aphrine 125mg/5ml Dry Suspension
Composition "Each 5ml After Reconstitution Contains:
Cephradine Monohydrate Eq. to Cephradine…125mg"
Diary No. Date of R& I & fee Dy. No 13387 dated 07-03-2019 Rs20,000/- (07-03-2019)
Pharmacological Group Antibacterial
Type of Form Form-5
Finished Product Specification USP
Pack Size & Demanded Price As per SRO
Approval Status of Product in Reference
Regulatory Authorities
Approved by MHRA of UK
Me-too Status Licef Dry Powder suspension 125mg/5ml by M/s Wisdom
Pharmaceuticals (Reg#078532)
GMP Status Central Licensing Board in its 270th meeting held on 23rd
May, 2019 has approved additional section
Remarks of the Evaluator.
Decision: Approved.
61. Name and address of manufacturer /
Applicant
M/s Arreta Pharmaceuticals Pvt Ltd. Plot No. 13, Street N-5,
RCCI, Industrial Estate, Rawalpindi
Brand Name +Dosage Form+Strength Arrelexin 125mg/5ml Dry Suspension
Composition "Each 5ml After Reconstitution Contains:
Cephalexin as Monohydrate…125mg"
Diary No. Date of R& I & fee Dy. No 13399 dated 07-03-2019 Rs20,000/- (07-03-2019)
Pharmacological Group Antibacterial
Type of Form Form-5
Finished Product Specification USP
Pack Size & Demanded Price As per SRO
Approval Status of Product in Reference
Regulatory Authorities
Approved by USFDA
Me-too Status Xesafin Suspension 125mg/5ml by MM/s Himont Pharma
(Pvt.) Ltd. 17 Km Ferozpur Road, Lahore. (Reg#076889)
GMP Status Central Licensing Board in its 270th meeting held on 23rd
May, 2019 has approved additional section
Remarks of the Evaluator.
Decision: Approved.
62. Name and address of manufacturer /
Applicant
M/s Arreta Pharmaceuticals Pvt Ltd. Plot No. 13, Street N-5,
RCCI, Industrial Estate, Rawalpindi
Brand Name +Dosage Form+Strength Arrelexin 250mg/5ml Suspension
Composition "Each 5ml After Reconstitution Contains:
Cephalexin as Monohydrate…250mg"
Diary No. Date of R& I & fee Dy. No 13399 dated 07-03-2019 Rs20,000/- (07-03-2019)
Pharmacological Group Antibacterial
Type of Form Form-5
Finished Product Specification USP
Pack Size & Demanded Price As per SRO
Approval Status of Product in Reference
Regulatory Authorities
Approved by USFDA
Me-too Status Xesafin Suspension 250mg/5ml by MM/s Himont Pharma
(Pvt.) Ltd. 17 Km Ferozpur Road, Lahore. (Reg#076880)
Minutes of 294th Meeting of Registration Board | 66
GMP Status Central Licensing Board in its 270th meeting held on 23rd
May, 2019 has approved additional section
Remarks of the Evaluator.
Decision: Approved.
63. Name and address of manufacturer /
Applicant
M/s Arreta Pharmaceuticals Pvt Ltd. Plot No. 13, Street N-5,
RCCI, Industrial Estate, Rawalpindi
Brand Name +Dosage Form+Strength Arofixime 100mg/5ml Dry Suspension
Composition "Each 5ml After Reconstitution Contains:
Cefixime Trihydrate Eq. to Cefixime…100mg"
Diary No. Date of R& I & fee Dy. No 13389 dated 07-03-2019 Rs20,000/- (07-03-2019)
Pharmacological Group Antibacterial
Type of Form Form-5
Finished Product Specification USP
Pack Size & Demanded Price As per SRO
Approval Status of Product in Reference
Regulatory Authorities
Approved by AEMPS of Spain
Me-too Status Fasxime 100mg Suspension of M/s Fassgen (R.# 053526)
GMP Status Central Licensing Board in its 270th meeting held on 23rd
May, 2019 has approved additional section
Remarks of the Evaluator.
Decision: Approved.
64. Name and address of manufacturer /
Applicant
M/s Arreta Pharmaceuticals Pvt Ltd. Plot No. 13, Street N-5,
RCCI, Industrial Estate, Rawalpindi
Brand Name +Dosage Form+Strength Arofixime 200mg/5ml Dry Suspension
Composition "Each 5ml After Reconstitution Contains:
Cefixime Trihydrate Eq. to Cefixime…200mg”
Diary No. Date of R& I & fee Dy. No 13390 dated 07-03-2019 Rs20,000/- 07-03-2019
(yellow slip)
Pharmacological Group Antibacterial
Type of Form Form-5 (Duplicate)
Finished Product Specification USP
Pack Size & Demanded Price As per SRO
Approval Status of Product in Reference
Regulatory Authorities
Approved by USFDA
Me-too Status Fasxime 200mg Suspension of M/s Fassgen (Reg#053527)
GMP Status Central Licensing Board in its 270th meeting held on 23rd
May, 2019 has approved additional section
Remarks of the Evaluator.
Decision: Approved. Board further decided that verification of fee challan shall be done as per
decision of 285th meeting of Registration Board.
65. Name and address of manufacturer /
Applicant
M/s Arreta Pharmaceuticals Pvt Ltd. Plot No. 13, Street N-5,
RCCI, Industrial Estate, Rawalpindi
Brand Name +Dosage Form+Strength Afurox 250mg/5ml Dry Suspension
Composition "Each 5ml After Reconstitution Contains:
Cefuroxime as Axetil…250mg"
Diary No. Date of R& I & fee Dy. No 13395 dated 07-03-2019 Rs20,000/- (07-03-2019)
Pharmacological Group Antibacterial
Type of Form Form-5
Finished Product Specification USP
Pack Size & Demanded Price As per SRO
Approval Status of Product in Reference
Regulatory Authorities
Approved by AEMPS of Spain
Me-too Status Cefuroscot Oral Suspension of M/s Scotmann (R.#029911)
Minutes of 294th Meeting of Registration Board | 67
GMP Status Central Licensing Board in its 270th meeting held on 23rd
May, 2019 has approved additional section
Remarks of the Evaluator.
Decision: Approved.
66. Name and address of manufacturer /
Applicant
M/s Arreta Pharmaceuticals Pvt Ltd. Plot No. 13, Street N-5,
RCCI, Industrial Estate, Rawalpindi
Brand Name +Dosage Form+Strength Arrenir 125mg/5ml Dry Suspension
Composition "Each 5ml After Reconstitution Contains:
Cefdinir…125mg"
Diary No. Date of R& I & fee Dy. No 13401 dated 07-03-2019 Rs20,000/- (07-03-2019)
Pharmacological Group Antibacterial
Type of Form Form-5
Finished Product Specification USP
Pack Size & Demanded Price As per SRO
Approval Status of Product in Reference
Regulatory Authorities
Approved by USFDA
Me-too Status Zefnir 125 mg Dry Powder Suspension of M/s Genome
Pharmaceuticals (Pvt,) Ltd, Hattar. (Reg.# 075525)
GMP Status Central Licensing Board in its 270th meeting held on 23rd
May, 2019 has approved additional section
Remarks of the Evaluator.
Decision: Approved.
Capsule Section Cephalosporin
4 molecules/5 products
67. Name and address of manufacturer /
Applicant
M/s Arreta Pharmaceuticals Pvt Ltd. Plot No. 13, Street N-5,
RCCI, Industrial Estate, Rawalpindi
Brand Name +Dosage Form+Strength Arrelexin 500mg Capsule
Composition "Each Capsule Contains:
Cephalexin as Monohydrate…500mg"
Diary No. Date of R& I & fee Dy. No 13398 dated 07-03-2019 Rs20,000/- (07-03-2019)
Pharmacological Group Antibacterial
Type of Form Form-5
Finished Product Specification USP
Pack Size & Demanded Price As per SRO
Approval Status of Product in Reference
Regulatory Authorities
Approved by USFDA
Me-too Status Halphix 500 mg Capsules of M/s Genome Pharmaceuticals
(Pvt,) Ltd, Hattar. (Reg.# 074521)
GMP Status Central Licensing Board in its 270th meeting held on 23rd
May, 2019 has approved additional section
Remarks of the Evaluator.
Decision: Approved.
68. Name and address of manufacturer /
Applicant
M/s Arreta Pharmaceuticals Pvt Ltd. Plot No. 13, Street N-5,
RCCI, Industrial Estate, Rawalpindi
Brand Name +Dosage Form+Strength Arrelexin 250mg Capsule
Composition "Each Capsule Contains:
Cephalexin as Monohydrate…250mg"
Diary No. Date of R& I & fee Dy. No 13397 dated 07-03-2019 Rs20,000/- (07-03-2019)
Pharmacological Group Antibacterial
Type of Form Form-5
Finished Product Specification USP
Pack Size & Demanded Price As per SRO
Approval Status of Product in Reference
Regulatory Authorities
Approved by USFDA
Minutes of 294th Meeting of Registration Board | 68
Me-too Status Halphix 250 mg Capsules of M/s Genome Pharmaceuticals
(Pvt,) Ltd, Hattar. (Reg.# 074520)
GMP Status Central Licensing Board in its 270th meeting held on 23rd
May, 2019 has approved additional section
Remarks of the Evaluator.
Decision: Approved.
69. Name and address of manufacturer /
Applicant
M/s Arreta Pharmaceuticals Pvt Ltd. Plot No. 13, Street N-5,
RCCI, Industrial Estate, Rawalpindi
Brand Name +Dosage Form+Strength Aphrine 250mg Capsule
Composition "Each Capsule Contains:
Cephradine Monohydrate Eq. to Cephradine…250mg"
Diary No. Date of R& I & fee Dy. No 13385 dated 07-03-2019 Rs20,000/- (07-03-2019)
Pharmacological Group Antibacterial
Type of Form Form-5
Finished Product Specification USP
Pack Size & Demanded Price As per SRO
Approval Status of Product in Reference
Regulatory Authorities
Cefradine 250mg Capsules by M/s Athlone Pharmaceuticals
Limited (MHRA Approved)
Me-too Status Zasinol 250mg capsule byM/s Martin Dow (Reg#080643)
GMP Status Central Licensing Board in its 270th meeting held on 23rd
May, 2019 has approved additional section
Remarks of the Evaluator.
Decision: Approved.
70. Name and address of manufacturer /
Applicant
M/s Arreta Pharmaceuticals Pvt Ltd. Plot No. 13, Street N-5,
RCCI, Industrial Estate, Rawalpindi
Brand Name +Dosage Form+Strength Arrenir 300mg Capsule
Composition "Each Capsule Contains:
Cefdinir…300mg"
Diary No. Date of R& I & fee Dy.No 13403 dated 07-03-2019 Rs20,000/- (07-03-2019)
Pharmacological Group Antibacterial
Type of Form Form-5
Finished Product Specification USP
Pack Size & Demanded Price As per SRO
Approval Status of Product in Reference
Regulatory Authorities
USFDA approved
Me-too Status Salus 300mg Capsule by M/s The Schazoo Pharmaceuticals
Laboratories (Pvt) Ltd (Reg#069407)
GMP Status Central Licensing Board in its 270th meeting held on 23rd
May, 2019 has approved additional section
Remarks of the Evaluator.
Decision: Approved.
71. Name and address of manufacturer /
Applicant
M/s Arreta Pharmaceuticals Pvt Ltd. Plot No. 13, Street N-5,
RCCI, Industrial Estate, Rawalpindi
Brand Name +Dosage Form+Strength Aphrine 500mg Capsule
Composition "Each Capsule Contains:
Cephradine Monohydrate Eq. to Cephradine…500mg"
Diary No. Date of R& I & fee Dy. No 13379 dated 07-03-2019 Rs20,000/- (07-03-2019)
Pharmacological Group Antibacterial
Type of Form Form-5
Finished Product Specification USP
Pack Size & Demanded Price As per SRO
Approval Status of Product in Reference
Regulatory Authorities
MHRA Approved
Minutes of 294th Meeting of Registration Board | 69
Me-too Status Biocef Capsules 500mg by M/s International Brands
(Registration No.013508)
GMP Status Central Licensing Board in its 270th meeting held on 23rd
May, 2019 has approved additional section
Remarks of the Evaluator.
Decision: Approved.
Central Licensing Board in its 273rd meeting held on 15th January, 2020 has considered and approved the
following additional section of firm M/s Scilife Pharma (Pvt) Ltd, Plot No. FD-57/58-A-2, Korangi Creek,
Industrial Park (KCIP) Karachi. Accordingly the Secretary CLB has issued letter for grant of additional section
dated 12th February, 2020.
Dry Powder Inhaler (General)
The panel inspection report on Investigation of Authenticity / Genuineness of data submitted for registration of
B-Form Rotacaps 400mcg + 12mcg (Budesonide + Formoterol fumarate dehydate) by M/s. Scilife Pharma
(Pvt). Ltd., Karachi considered by Registration Board in its 291st meeting has already confirmed the following:
Precautionary measures adopted by the firm to control of cross contamination of the steroidal
preparation with the general products during the manufacturing of applied formulations
Availability of specialized mixing facility to ensure the required particle size of formulation blend
including multi-directional-mixer having 3D mixing capability to ensure the homogeneous mixing of
APIs.
Availability of necessary apparatus for the performance of uniformity of deliver dose and aerodynamic
particle size including dose Uniformity sampling apparatus and MSLI(Multistage Liquid Impinger) for
aerodynamic particle size distribution.
Now, the firm has requested for the priority consideration following applications
Dry Powder Inhaler (General)
1 Molecules/ 09 Products
72. Name and address of manufacturer /
Applicant
"M/s Scilife Pharma Pvt Ltd. Plot # FD-57/58-A2, Korangi
Creek Industrial Park, Karachi"
Brand Name +Dosage Form+Strength Captair 150mcg Capsule
Composition "Each Capsule Contains:
Indacaterol Maleate eq to Indacaterol…150mcg"
Diary No. Date of R& I & fee Dy. No 10739 dated 05-03-2019 Rs.20,000/- (04-03-2019)
Pharmacological Group Selective beta-2-adrenoreceptor agonists
Type of Form Form 5
Finished Product Specification Manufacturer’s specifications
Pack Size & Demanded Price As per SRO
Approval Status of Product in Reference
Regulatory Authorities
Onbrez Breezhaler 150 microgram inhalation powder, hard
capsules approved by HPRA of Ireland.
Me-too Status Onbrez Breezhaler 150 microgram inhalation powder, hard
capsules by M/s Novartis Pharma, Islamabad.
(Reg.#069586)
GMP Status 10-07-2018./ GMP compliance level is rated as GOOD
Remarks of the Evaluator.
Decision: Approved with innovator’s specification.
73. Name and address of manufacturer /
Applicant
"M/s Scilife Pharma Pvt Ltd. Plot # FD-57/58-A2, Korangi
Creek Industrial Park, Karachi"
Brand Name +Dosage Form+Strength Captair 300mcg Capsule
Composition "Each Capsule Contains:
Indacaterol Maleate eq to Indacaterol…300mcg"
Diary No. Date of R& I & fee Dy. No 10740 dated 05-03-2019 Rs.20,000/- (04-03-2019)
Pharmacological Group Selective beta-2-adrenoreceptor agonists
Type of Form Form 5
Finished Product Specification Manufacturer’s specifications
Pack Size & Demanded Price As per SRO
Minutes of 294th Meeting of Registration Board | 70
Approval Status of Product in
Reference Regulatory Authorities
Onbrez Breezhaler 300 microgram inhalation powder, hard
capsules approved by HPRA of Ireland.
Me-too Status Onbrez Breezhaler 300 microgram inhalation powder, hard
capsules by M/s Novartis Pharma (Reg.#069587`)
GMP Status 10-07-2018./ GMP compliance level is rated as GOOD
Remarks of the Evaluator.
Decision: Approved with innovator’s specification.
74. Name and address of manufacturer /
Applicant
"M/s Scilife Pharma Pvt Ltd. Plot # FD-57/58-A2, Korangi
Creek Industrial Park, Karachi"
Brand Name +Dosage Form+Strength Indigo 110/50mcg Capsule
Composition "Each capsule contains
Indacaterol as maleate……110mcg
Glycopyrronium as bromide……50mcg"
Diary No. Date of R& I & fee Dy. No 10740 dated 05-03-2019 Rs.20,000/- (04-03-2019)
Pharmacological Group Drugs for obstructive airway diseases, adrenergics in
combination with anticholinergics
Type of Form Form 5
Finished Product Specification Manufacturer’s specifications
Pack Size & Demanded Price As per SRO
Approval Status of Product in
Reference Regulatory Authorities
Ultibro Breezhaler inhalation powder hard capsules approved by
EMA
Me-too Status Ultibro Breezhaler inhalation powder hard capsules by M/s
Novartis Pharma (Pakistan) Limited. (Reg.#088393)
GMP Status 10-07-2018./ GMP compliance level is rated as GOOD
Remarks of the Evaluator.
Decision: Registration Board deliberated that since the referred me-too product “Ultibro Breezhaler
by M/s Novartis Pharma (Pakistan) Limited. (Imported) Reg. No. 088393” was first approved in
254th meeting of Registration Board, and the Board in its 240th meeting has already decided that
stability studies data will be required for new formulation and its subsequent generic, hence Board
deferred the case for submission of stability study data as per the guidelines provided in 278th and
293rd meeting of Registration Board as it’s a subsequent generic.
75. Name and address of manufacturer /
Applicant
"M/s Scilife Pharma Pvt Ltd. Plot # FD-57/58-A2, Korangi
Creek Industrial Park, Karachi"
Brand Name +Dosage Form+Strength Salme-F DPI 500/50mcg Capsule
Composition Each Capsule Contains:
Fluticasone Propionate…..500mcg
Salmeterol as Xinafoate……50mcg
Diary No. Date of R& I & fee Dy. No 23598 dated 08-12-2017 Rs.20,000/- (08-12-2017)
Pharmacological Group β-2 agonists/long-acting corticosteroids
Type of Form Form-5
Finished Product Specification USP
Pack Size & Demanded Price As per Drug pricing policy
Approval Status of Product in
Reference Regulatory Authorities
Seretide Accuhaler 50 microgram/500microgram /dose
inhalation powder, pre-dispensed. Approved by MHRA.
Me-too status Oxytide-F50/500DPI capsule of M/s Werrick (R.#095348).
GMP status 10-07-2018./ GMP compliance level is rated as GOOD
Remarks of the Evaluator2 The firm has submitted details of label claim & product
specifications as recommended by Registration board in its 290th
meeting regarding the Manufacturing Requirements for
Rotacaps (Dry powder Inhaler)
Decision: Approved.
76. Name and address of manufacturer /
Applicant
"M/s Scilife Pharma Pvt Ltd. Plot # FD-57/58-A2, Korangi
Creek Industrial Park, Karachi"
Brand Name +Dosage Form+Strength Salme-F DPI 250/50mcg Capsule
Minutes of 294th Meeting of Registration Board | 71
Composition Each Capsule Contains:
Fluticasone Propionate…..250mcg
Salmeterol as Xinafoate……50mcg
Diary No. Date of R& I & fee Dy. No 23596 dated 08-12-2017 Rs. 20,000/- (08-12-2017)
Pharmacological Group β-2 agonists/long-acting corticosteroids
Type of Form Form-5
Finished Product Specification Manufacturer specifications
Pack Size & Demanded Price As per Drug pricing policy
Approval Status of Product in
Reference Regulatory Authorities
Seretide Accuhaler 50 microgram /250 microgram /dose
inhalation powder, pre-dispensed. Approved by MHRA.
Me-too status Seretide Diskus 50/250mcg Powder For Inhalation of M/s
Glaxosmithkline Pakistan Limited, Karachi. (Reg. #074727).
GMP status 10-07-2018./ GMP compliance level is rated as GOOD
Remarks of the Evaluator2 The firm has submitted details of label claim & product
specifications as recommended by Registration board in its 290th
meeting regarding the Manufacturing Requirements for Rotacaps
(Dry powder Inhaler)
Decision: Approved with innovator’s specification.
77. Name and address of manufacturer /
Applicant
"M/s Scilife Pharma Pvt Ltd. Plot # FD-57/58-A2, Korangi
Creek Industrial Park, Karachi"
Brand Name +Dosage Form+Strength Salme-F DPI 100/50mcg Capsule
Composition Each Capsule Contains:
Fluticasone Propionate…..100mcg
Salmeterol as Xinafoate……50mcg
Diary No. Date of R& I & fee Dy. No 23597 dated 08-12-2017 Rs. 20,000 (08-12-2017)
Pharmacological Group β-2 agonists/long-acting corticosteroids
Type of Form Form-5
Finished product Specification Manufacturer specifications
Pack size & Demanded Price As per Drug pricing policy
Approval status of product in
Reference Regulatory Authorities.
Seretide Accuhaler 50 microgram /100 microgram /dose
inhalation powder, pre-dispensed. Approved by MHRA.
Me-too status Seretide Diskus 50/100mcg Powder For Inhalation of M/s
Glaxosmithkline Pakistan Limited, Karachi. (Reg. #074726).
GMP status 10-07-2018./ GMP compliance level is rated as GOOD
Remarks of the Evaluator2 The firm has submitted details of label claim & product
specifications as recommended by Registration board in its 290th
meeting regarding the Manufacturing Requirements for
Rotacaps (Dry powder Inhaler)
Decision: Approved with innovator’s specification.
78. Name and address of manufacturer /
Applicant
"M/s Scilife Pharma Pvt Ltd. Plot # FD-57/58-A2, Korangi Creek
Industrial Park, Karachi"
Brand Name+Dosage Form+ Strength B-Form Rotacaps 400mcg+12mcg
Composition Each Capsule Contains:
Each capsule contains:-
Budesonide…..400mcg
Formoterol fumarate dihydrate……. 12 mcg
Diary No. Date of R& I & fee Dy. No 07-04-2017 Rs. 20,000/-
Pharmacological Group Glucocorticosteroid/Selective β2 adrenoceptor agonist
Type of Form Form-5
Finished product Specification Manufacturer specifications
Pack size & Demanded Price As per Drug pricing policy
Approval status of product in
Reference Regulatory Authorities.
Symbicort Turbuhaler approved by Health Canada
Me-too status Venticort Rotacaps by M/s Macter Pharma (Reg. #089365).
Minutes of 294th Meeting of Registration Board | 72
GMP status 10-07-2018./ GMP compliance level is rated as GOOD.
Remarks of the Evaluator2 The case was presented in 291st meeting along with details
of stability studies data & report of on-site panel inspection
report which is reproduced as under:
STABILITY STUDY DATA
Drug B-Form Rotacaps 400mcg+12mcg
Name of Manufacturer M/s Scilife Pharma (Pvt.) Ltd., Karachi.
Manufacturer of APIs M/s Vamsi labs Ltd., Maharashtra, India
API Lot No. Formoterol fumarate dihydrate: FF-0030317
Budesonide: BDS-0100517
Description of Pack
(Container closure system) Alu –Alu blister with unit carton
Stability Storage Condition Real time : 30°C ± 2°C / 75% ± 5%RH
Accelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real time: 6 months Accelerated: 6 months
Frequency Accelerated: 0,3,6 month Real Time: 0,3,6 month
Batch No. 210B17 211B17 212B17
Batch Size 26000 rotacaps 26000 rotacaps 26000 rotacaps
Manufacturing Date 28-12-2017 28-12-2017 28-12-2017
Date of Initiation 19-01-2018 19-01-2018 19-01-2018
No. of Batches 03
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr.# Documents To Be Provided Status
1. COAS of API Yes.
2. Approval of API by regulatory authority of country of
origin or GMP certificate of API manufacturer issued by
regulatory authority of country of origin.
Copy of GMP certificate (certificate# NEW-
WHO-GMP/CERT/PD/75003/2018/1/25587)
issued by Food and Drug Administration
Maharashtra to M/s Vamsi labs Ltd.,
Maharashtra, India valid till 02-11-2021
3. Protocols followed for conduction of stability study and
details of tests. Yes
4. Data of 03 batches will be supported by attested
respective documents like chromatograms, laboratory
reports, data sheets etc.
Yes
5. Documents confirming import of API etc. Copy of Form 6 & commercial invoice has been
submitted attested by Assistant Director (I & E)
DRAP, Karachi
6. All provided documents will be attested (name, sign and
stamp) for ensuring authenticity of data / documents. Yes
7. Commitment to continue real time stability study till
assigned shelf life of the product. Yes
8. Commitment to follow Drug Specification Rules, 1978. Yes
REMARKS OF EVALUATOR
Minutes of 294th Meeting of Registration Board | 73
Sr.# Observation Firm’s Response
i.
Evidence of approval of applied
formulation in similar dosage form as
applied, by reference regulatory
authorities/agencies, which were adopted
by the Registration Board in its 275th
meeting.
Firm has referred to product “Venticort” with similar
composition of Macter International Karachi, approved
by Registration Board in its 275th meeting.
Moreover firm has referred that applied dosage form is
a cost effective approach as compared to reference
product.
ii.
Label claim for delivered dose shall be
submitted, based upon the performance
tests identified by USP in its general
chapter <601>.
Firm has submitted results for “Uniformity of delivered
dose” by Dose Uniformity Sampling Apparatus at 9th
month long term stability time point.
On the basis of above performance test firm has
submitted following label claim:
“Each delivered dose (the dose that leaves the
mouthpiece) contains:
“Budesonide ……. 320mcg
Formoterol fumarate dehydrate….. 9mcg”
iii.
Following performance quality &
specific tests as identified by USP in its
general chapter <5> & <601> have not
been performed during stability studies:
Aerodynamic size distribution.
Microbial Enumeration test
Test for specified microorganisms
Foreign particulate matter.
Uniformity of delivered dose
Firm has submitted results for following tests at 9th
month long term stability time point:
Aerodynamic size distribution.
Microbial Enumeration test
Test for specified microorganisms
Foreign particulate matter.
Uniformity of delivered dose
Report on Investigation of Authenticity / Genuineness of data submitted for registration of B-Form
Rotacaps 400mcg + 12mcg (Budesonide + Formoterol fumarate dehydate) by M/s. Scilife Pharma (Pvt).
Ltd., Karachi.
Reference No: F.3-11/2017-PEC (Pt) dated 30th July, 2019.
Investigation Date and Time: 31st July, 2019 (Morning).
Investigation Site: Factory premises of M/s. Scilife Pharma (Pvt). Ltd., Korangi Creek, Industrial State,
Karachi.
Background:
Chairman Registration Board considered the applications of M/s. Scilife Pharma (Pvt). Ltd., Korangi Creeck,
Industrial State, Karachi for registration of B-Form Rotacaps 400mcg + 12mcg (Budesonide + Formoterol
fumarate dehydrate) and constituted a three-member panel to investigate the authenticity / genuineness of
data (import of raw material and stability data). Panel was advised to conduct inspection of the firm and to
submit report for further consideration.
Composition of Panel:
1. Director, Drug Testing Laboratory, Government of Sindh, Karachi.
2. Dr. Saif ur Rehman Khattak, Director, CDL, DRAP, Karachi.
3. Mr. Asfandyar Ajab Khan, Assistant Director, CDL, DRAP, Karachi.
Scope of investigation:
Investigation of the authenticity / genuineness of data (import of raw material and stability data),
manufacturing of stability batches and stability studies on these batches.
Tools for Investigation:
The investigation was conducted by using a structured questionnaire of DRAP. For objective evidence
physical inspection of the facilities for manufacturing and quality control, material used and retained,
personnel involved, ongoing studies, printed data and integrity and security of data in respective databases
were also audited. The details of investigation may be summarized as under:
B-FORM ROTACAPS 400MCG + 12MCG
Minutes of 294th Meeting of Registration Board | 74
Sr.# Question Observation by panel
1. Do you have documents confirming the
import of API?
The firm has imported:
50g Budesonide API (Batch no: BSD-0100517) and
10g Formoterol Fumarate dihydrate API (Batch No. FF no:
0030317) from Vamsi Labs Ltd. India. Proper approval taken
from DRAP dated 30.11.2017,
and respectively
2. What was the rationale behind selecting
the particular manufacturer of API?
There is proper vendor evaluation form being implemented by
the firm. The parameters included in this form are, DMF status,
GMP certificate, Stability data, provision of reference standard
of API and impurities standards etc. The firm has evaluated on
this criteria and has been selected accordingly.
3. Do you have documents confirming the
import of reference standard and
impurity standards?
The firm has imported Budesonide + Formeterol Fumerate
dihydrate working standard from the API manufacturer Vamsi
Labs Ltd., India). Moreover the firm has imported reference
standards and impurity standards from Eur. Ph. for both APIs.
4. Do you have certificate of Analysis of
the API, reference standards and
impurity standards?
The firm has certificates of analysis of both the API, reference
standard and impurities standards.
5. Do you have any approval of API or
GMP certificate of API manufacturer
issued by regulatory authority of country
of origin?
Firm has valid GMP certificate of Budesonide API and
Formoterol Fumarate dihydrate API issued by regulatory
authority of their respective country of origin from Joint
Commissioner (HQ) & controlling Authority, FDA
administration, M.S. Bandra (E), Mumbai, Maharashtra state,
India.
6. Do you use API manufacturer method of
testing?
The Firm used Eur. Ph compendial method for API which is the
same as that of manufacturer`s
7. Do you have stability studies reports on
API?
The firm has stability studies report on APIs (Budesonide +
formeterol fumerate dihydrate) conducted by API
manufacturers.
8. If whether the stability testing has been
performed as per SIM method &
degradation products have been
quantified?
The manufacturer of both APIs has performed the stability
studies on APIs as per SIM method and the degradation
products have been quantified.
9. Do you have method for quantifying the
impurities in the API?
The firm has method for quantifying the impurities by Eur. Ph
in the APIs
10. Do you have some remaining quantities
of the API, its reference standard and
impurities standards?
The firm has remaining quantities of APIs, reference standards
and impurities standards.
11. Have you used pharmaceutical grade
excipients?
The firm has used pharmaceutical grade excipient Lactose
monohydrate (respitose).
12. Do you have documents confirming the
import of the used excipients?
The firm has relevant documents confirming the import of the
used excipient. Proper approval taken from DRAP on invoice
9003327957 dated 07.11.2017.
13. Do you have test reports and other
records on the excipients used?
The firm has test reports and other records on the excipients
used.
14. Do you have written and authorized
protocols for the development of the
product?
The firm has written and authorized protocol for the
development of the product (Budesonide + formeterol fumerate
dihydrate) 400+12 rotacaps.
Minutes of 294th Meeting of Registration Board | 75
15. Have you performed Drug-excipients
compatibility studies?
The firm has not performed Drug-excipients compatibility
studies as their formulation is similar to that of the reference
product formulation.
16. Have you performed comparative
studies?
The firm has conducted comparative studies with leading
generic product of M/S. Incepta Pharma, Bangladesh (Budimat
inhaler). Both the products have comparative profiles. The firm
will also conduct studies with innovator product before
commercial manufacturing.
17. Do you have product development
(R&D) section
The firm has well equipped exclusive product development
(R&D) section.
18. Do you have necessary equipment’s
available in product development section
for development of the product?
The firm has necessary equipment’s for production of
(Budesonide + formeterol fumerate dihydrate) 400+12 rotacaps
in product development section.
19. Are the equipments in product
development section qualified?
The equipment in product development section are qualified.
20. Do you have proper maintenance /
calibration / re-qualification program for
the equipment used in PD section?
The firm has proper maintenance / calibration / re-qualification
program for the equipment used in PD section.
21. Do you have qualified staff in product
development section with proper
knowledge and training in product
development?
The firm has a team of 3 pharmacists and 4 chemist, 1
biotechnologist with a machine operator in product
development section with suitable knowledge and training in
product development.
22. Have you manufactured three stability
batches for the stability studies of the
product as required?
The firm has manufactured three stability batches as
follows;
1) 210B17, 2) 211B17 and 212B17
23. Do you have any criteria for fixing the
batch size of stability batches?
The criteria for fixing the batch size of stability batches, as
informed by the firm, was based on the quantity required for
stability study (i.e. number of capsules per testing frequency and
number of testing frequencies / intervals) and minimum
working Capacity of the equipment.
24. Do you have complete record of
production of stability batches?
Firm has complete record of production of stability batches.
25. Do you have protocols for stability
testing of stability batches?
The firm has detailed protocol for stability testing of stability
batches.
26. Do you have developed and validated the
method for testing of stability batches?
The firm has developed and validated method for testing of
stability batches of finish product i.e. B Form DS (Budesonide
+ formeterol fumerate dihydrate) 400/12 rotacaps. The method
is stability indicating.
27. Do you have method transfer studies in
case when the method of testing being
used by your firm is given by any other
lab?
Transfer studies not applicable.
28. Do you have documents confirming the
qualification of equipments / instruments
being used in the test and analysis of API
and the finished drug?
The firm has proper documents confirming the qualification of
equipment / instruments being used in the test and analysis of
APIs and the finished product.
29. Do your method of analysis stability
indicating?
Firm’s method of analysis was stability indicating and the
record of testing of stability batches available.
30. Do your HPLC software is 21CFR
compliant?
The HPLC software is 21CFR Compliant as per record of the
firm. Audit trail was active on all HPLC systems used
Minutes of 294th Meeting of Registration Board | 76
throughout stability study. Individual user log in and IDs were
available.
31. Can you show Audit Trail reports on
product testing?
Audit trail reports were available and randomly checked.
32. Do you have some remaining quantities
of degradation products and stability
batches?
The firm has only remaining quantities of stability batches kept
on real-time stability testing.
33. Do you have stability batches kept on
stability testing?
The firm has completed the accelerated stability testing on the
three stability batches however the real time stability testing is
in progress on all the three stability batches. First three
validation batches to be kept on stability.
34. Do you have valid calibration status for
the equipment’s used in production and
analysis?
The Firm has valid calibration status for the equipment used in
production and analysis of the product.
35. Do proper and continuous monitoring
and control are available for stability
chamber?
Continuous power supply and monitoring are available for
stability chambers.
Sr.# Question Observation by panel
36. Observations of PEC?
a) Precautionary measures adopted to
control of cross contamination of the
steroidal preparation with the general
products during the manufacturing of
applied formulations
The firm has taken several steps to control the cross-
contamination for steroidal preparation as below,
i) Installed, Qualified and Maintained dedicated Sampling /
Dispensing booth in the separate area for the handling of
steroidal raw materials to avoid the cross contamination as
Starting point of manufacturing.
ii) Dedicated multi-directional mixer for mixing of steroidal
formulations available
iii) Dedicated change parts available for the encapsulation of
(Budesonide + Formoterol fumarate dihydrate) 400/12mcg
that will ensure and minimize the risk cross contamination
during filling process
iv) Dedicated change parts along with auto feeder is installed
and available for the blistering of (Budesonide + Formoterol
fumarate dihydrate) 400/12mcg that will further ensure the
control of cross contamination during blistering and primary
packaging process.
v) In addition to that, firm executed the PRE/POST cleaning
validation studies on approved protocol for steroidal
formulations based on worst-case scenario to make sure the
prevention of cross contamination.
vi) Isolation gowning has been provided for this product.
b) Availability of specialized mixing
facility to ensure the required particle
size of formulation blend
The firm has executed and maintained the following steps for the
obtaining required particle size of formulation blend as given
below,
i) The firm used both the APIs Budesonide and Formoterol
fumarate dihydrate having controlled and special particle size
required for inhaler preparation as less than 5µm.
ii) The firm has also used inhaler grade excipients Lactose i.e.
Respitose having required particle size.
iii) Design and developed the Two stage mixing mechanism on
multi-directional-mixer having 3D mixing capability to
ensure the homogeneous mixing of APIs in blended
Minutes of 294th Meeting of Registration Board | 77
formations having desired particle size. The same has been
qualified through approved qualification protocol.
iv) In addition to that the final blend of each batch will be tested
on 10 point sampling method and checked on HPLC to make
sure the equal and homogeneous distribution of both the APIs
in formulation blend before start next step.
c) Availability of necessary apparatus
for the performance of uniformity of
deliver dose and aerodynamic particle
size
The firm has necessary apparatus for the performance of
uniformity of deliver dose which is Dose Uniformity sampling
apparatus and aerodynamic particle size distribution which is
MSLI (Multistage Liquid Impinger) available and qualified to test
the product.
d) Detailed of the drug delivery device
(Inhaler) intended to be marketed
along with the applied formulation.
i) We are importing the DPI Device (SciAir) from TAIAN
DALU MEDICAL INSTRUMENT CO., LTD. CHINA
under import license ELI-00187 for importing the inhaler
device issue by Secretary Medical device board dated 19-10-
2018 having 5 years expiry.
ii) The device (DL-D02) bear the mark, showing
Compliance of the designated product with the Directive
93/42/EEC has been assessed and certified by the Notified
Body TÜV Rheinland LGA Products GmbH following the
procedure relating to the EC Declaration of Conformity set
out in Annex V of Directive 93/42/EEC.
iii) The SciAir device main structure and performance are as
following:
a. Protection cap: Contain and protect the inner parts and avoid
pollution.
b. Mouthpiece: For helping users to inhale the powder
medication effectively.
c. Capsule cavity: Contain capsule.
d. Push button: For users to puncture the capsule to inhale the
powder.
e. Back piece: For seal the device bottom and supporting
function.
iv) SciAir DPI device enlistment with MD board having
enlistment no. MDIE-0000028, dated
v) 12/07/2019
vi) How to use: patient information leaflet attached for review.
e) Results for uniformity of delivered
dose by dose uniformity sampling
apparatus performed at 9th month of
long term stability time point
Results for uniformity of delivered dose by dose uniformity
sampling apparatus performed at 9th month of long term stability
time point has been checked and verified. Results are satisfactory.
f) Results for the following tests
performed at the 9th month of long term
stability time point
i) Aerodynamic size distribution
ii) Micro enumeration test
iii) Test for specified microorganisms
iv) Foreign particulate matter
Results for the following tests performed at the 9th month of long
term stability time point has been checked and verified.
i) Aerodynamic size distribution
ii) Micro enumeration test
iii) Test for specified microorganism
iv) Foreign particulate matter
Results are satisfactory.
Conclusion and Recommendations:
1. On the basis of risk-based approach the genuineness / authenticity of stability data submitted by the firm
for registration of B-Form Rotacaps 400mcg + 12mcg (Budesonide/Formoterol Fumarate dehydrate) is
verifiable to satisfactory level.
Minutes of 294th Meeting of Registration Board | 78
2. The firm has provided a number of measures and arrangements to minimize the risk of cross-
contamination including specialized dedicated dispensing booth, 3D mixer, dedicated change parts on
capsules filling machine, pre and post operation cleaning validation, work station exposure studies and
special gowning in addition to effective HVAC system. All the above mentioned measures / arrangements
technically reduce the chances of cross-contamination to satisfactory level. The arrangements, controls
and studies being made by the firm for manufacturing B-Form Rotacaps 400mcg / 12mcg of desired
quality can be rated satisfactory. Any special arrangement or decision related to manufacturing of DPIs
may kindly be rechecked by the board for uniform and effective compliance.
3. Registration of the product (B-Form Rotacaps 400mcg / 12mcg) is recommended in the name of the
manufacturer.
Decision of 291st meeting: Registration Board deferred the case for the requirement of separate section of “Dry
powder Inhaler Capsules” as decided by Board in its 290th meeting.
Evaluation by PEC:
Now the Central Licensing Board in its 273rd meeting held on 15th January, 2020 has considered and approved
the additional section of “Dry Powder Inhaler (General)” in the name of M/s Scilife Pharma (Pvt.) Ltd, Plot No.
FD-57/58-A-2, Korangi Creek, Industrial Park (KCIP) Karachi.
Decision of 294th meeting: Registration Board decided to approve registration of B-Form
Rotacaps 400mcg+12mcgwith Innovator’s specifications by M/s Scilife Pharma (Pvt.) Ltd Plot
FD-57/58-A2 Korangi Creek Industrial Park Karachi. Manufacturer will place first three
production batches of the product on long term stability studies throughout proposed shelf life
and on accelerated studies for six months.
Case No. 07 Registration applications of drugs for which stability study data is submitted
a. Deferred cases
79. Name and address of manufacturer /
Applicant
M/s CCL Pharmaceuticals Pvt. Ltd, 62 Industrial Estate, Kot
Lakhpat, Lahore.
Brand Name+Dosage Form+ Strength Censipar tablet 60mg
Composition "Each film coated tablet Contains:
Cinacalcet as hydrochloride…..…60mg"
Diary No. Date of R& I & fee Dy.No.16788 (03-10-2017); Rs. 50,000/- (03-10-2017)
Pharmacological Group Calcimimetic
Type of Form Form-5D
Finished product Specifications Manufacturer’s speci fications
Pack size & Demanded Price As per PRC
Approval status of product in
Reference Regulatory Authorities
Approved by USFDA
Me-too status (with strength and
dosage form)
GMP status
Remarks of the EvaluatorII
Now the firm has submitted stability data detailed as under:
STABILITY STUDY DATA
Drug Censipar tablet 60mg
Name of Manufacturer M/s CCL Pharmaceuticals Pvt. Ltd, 62 Industrial Estate, Kot Lakhpat, Lahore.
Manufacturer of API Cinacalcet hydrochloride: M/s Ind-Swift Laboratories Ltd., Punjab, India
API Lot No. 1233040001
Description of Pack
(Container closure system) Alu-Alu foil in unit carton
Stability Storage Condition Real time : 30°C ± 2°C / 65% ± 5%RH
Minutes of 294th Meeting of Registration Board | 79
Accelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real time: 6 months Accelerated: 6 months
Frequency Real Time: 0,3,6 months Accelerated: 0,3,6 months
Batch No. CNB-T2-18 CNB-T3-18 CNB-T4-18
Batch Size 2000 tablets 2000 tablets 2000 tablets
Manufacturing Date 09-2018 09-2018 09-2018
Date of Initiation 23-10-2018 23-10-2018 23-10-2018
No. of Batches 03
Date of Submission 03-06-2019 (Dy. No. 7864)
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Documents To Be Provided Status
COA of API Yes
Approval of API by regulatory authority of country
of origin or GMP certificate of API manufacturer
issued by regulatory authority of country of origin.
Copy of GMP Certificate for M/s Ind-Swift Laboratories
Ltd., Punjab, India issued by Food & Drug
Administration, Punjab, India has been submitted, valid
upto 11-2019.
Protocols followed for conduction of stability
study and details of tests. Yes
Data of 03 batches will be supported by attested
respective documents like chromatograms,
laboratory reports, data sheets etc.
Yes
Documents confirming import of API etc. Copy of invoice for Cinacalcet hydrochloride, attested by
Assistant Director (I & E) DRAP, Lahore dated 13-04-
2018 has been submitted.
All provided documents will be attested (name,
sign and stamp) for ensuring authenticity of data /
documents.
Yes
Commitment to continue real time stability study
till assigned shelf life of the product. Yes
Commitment to follow Drug Specification Rules,
1978. Yes
REMARKS OF EVALUATOR
The frequency of testing for accelerated stability studies is not as per recommendations of 278th meeting
of Registration Board i.e., 0, 1,2,3,4 & 6 month.
You have not performed uniformity of dosage unit by content uniformity, as recommended by USP
General Chapter <905> throughout stability studies. Justification shall be submitted in this regard.
Justification for value of Q=70% in the dissolution test shall be submitted since USP chapter <1092>
(The Dissolution Procedure; Development and Validation) recommends Q values in the range of 75% - 80% for
immediate release dosage forms.
In response to above observations, firm has submitted as under:
Regret to inform you that accelerated stability studies at 0,3 & 6 months were performed as per ICH
guidelines. We commit that we will perform accelerated stability studies at 0,1,2,3,4 & 6 months as per DRAP
guidelines from 1st August 2019 to onward for new products.
We commit to incorporate content uniformity of dosage unit by assay method in our product test method
and will analyse real time stability batches for content uniformity. You may verify the same during on-site
inspection.
Minutes of 294th Meeting of Registration Board | 80
As identified by your good office, we hereby agree to revise the limit of Q=-75% for Cinalcalcet in the
dissolution test.
80. Name and address of manufacturer /
Applicant
M/s CCL Pharmaceuticals Pvt. Ltd, 62 Industrial Estate, Kot
Lakhpat, Lahore.
Brand Name+Dosage Form+ Strength Censipar tablet 30mg
Composition "Each film coated tablet Contains:
Cinacalcet as hydrochloride…..…30mg"
Diary No. Date of R& I & fee Dy.No.16786 (03-10-2017); Rs. 50,000/- (03-10-2017)
Pharmacological Group Calcimimetic
Type of Form Form-5D
Finished product Specifications Manufacturer’s specifications
Pack size & Demanded Price As per PRC
Approval status of product in
Reference Regulatory Authorities
Approved by USFDA
Me-too status (with strength and
dosage form)
GMP status
Remarks of the EvaluatorII
Now the firm has submitted stability data detailed as under:
STABILITY STUDY DATA
Drug Censipar tablet 30mg
Name of Manufacturer M/s CCL Pharmaceuticals Pvt. Ltd, 62 Industrial Estate, Kot Lakhpat, Lahore.
Manufacturer of API Cinacalcet hydrochloride: M/s Ind-Swift Laboratories Ltd., Punjab, India
API Lot No. 1233040001
Description of Pack
(Container closure system) Alu-Alu foil in unit carton
Stability Storage Condition Real time : 30°C ± 2°C / 65% ± 5%RH
Accelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real time: 6 months Accelerated: 6 months
Frequency Real Time: 0,3,6 months Accelerated: 0,3,6 months
Batch No. CNA-T2-18 CNA-T3-18 CNA-T4-18
Batch Size 2000 tablets 2000 tablets 2000 tablets
Manufacturing Date 09-2018 09-2018 09-2018
Date of Initiation 23-10-2018 23-10-2018 23-10-2018
No. of Batches 03
Date of Submission 03-06-2019 (Dy. No. 7864)
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Documents To Be Provided Status
COA of API Yes
Approval of API by regulatory authority of country
of origin or GMP certificate of API manufacturer
issued by regulatory authority of country of origin.
Copy of GMP Certificate for M/s Ind-Swift Laboratories
Ltd., Punjab, India issued by Food & Drug Administration,
Punjab, India has been submitted, valid upto 11-2019.
Protocols followed for conduction of stability
study and details of tests. Yes
Data of 03 batches will be supported by attested
respective documents like chromatograms, Yes
Minutes of 294th Meeting of Registration Board | 81
laboratory reports, data sheets etc.
Documents confirming import of API etc. Copy of invoice for Cinacalcet hydrochloride, attested by
Assistant Director (I & E) DRAP, Lahore dated 13-04-2018
has been submitted.
All provided documents will be attested (name,
sign and stamp) for ensuring authenticity of data /
documents.
Yes
Commitment to continue real time stability study
till assigned shelf life of the product. Yes
Commitment to follow Drug Specification Rules,
1978. Yes
REMARKS OF EVALUATOR
The frequency of testing for accelerated stability studies is not as per recommendations of 278th meeting
of Registration Board i.e., 0, 1,2,3,4 & 6 month.
You have not performed uniformity of dosage unit by content uniformity, as recommended by USP
General Chapter <905> throughout stability studies. Justification shall be submitted in this regard.
Justification for value of Q=70% in the dissolution test shall be submitted since USP chapter <1092>
(The Dissolution Procedure; Development and Validation) recommends Q values in the range of 75% - 80% for
immediate release dosage forms.
In response to above observations, firm has submitted as under:
Regret to inform you that accelerated stability studies at 0,3 & 6 months were performed as per ICH
guidelines. We commit that we will perform accelerated stability studies at 0,1,2,3,4 & 6 months as per DRAP
guidelines from 1st August 2019 to onward for new products.
We commit to incorporate content uniformity of dosage unit by assay method in our product test method
and will analyse real time stability batches for content uniformity. You may verify the same during on-site
inspection.
As identified by your good office, we hereby agree to revise the limit of Q=-75% for Cinalcalcet in the
dissolution test.
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Censipar tablet
30mg & 60mg by M/s CCL Pharmaceuticals Pvt. Ltd, 62 Industrial Estate, Kot Lakhpat, Lahore.
Reference No: No.F.13-11/2017-PEC (Pt) dated 19-08-2019..
Investigation Date and Time: 12-11-2019.
Investigation Site: Factory premises of M/s CCL Pharmaceuticals (Pvt.) Ltd., 62 Industrial Estate,
KotLakhpat, Lahore
Composition of Panel:
1. Mr. Shaheen Iqbal Director, DTL, Lahore.
2. Ms. Aisha Irfan Area FID, DRAP, Lahore.
3. Ms. Maham Misbah Assistant Director, DRAP, Lahore.
Focus of Inspection:
Inspection was focused on a thorough evaluation of data for stability studies of following products namely:
Sr. No. Name / Composition of Drugs
01 Censipar Tablet 30mg
Each film coated tablet contains:
Cinacalcet (as HCl)………………………30mg
02 Censipar Tablet 60mg
Each film coated tablet contains:
Cinacalcet (as HCl)………………………60mg
Minutes of 294th Meeting of Registration Board | 82
Detail of investigation:
Q.# Questions Observation by panel
1. Do you have documents confirming the import of
Cinacalcet HCl including approval from DRAP?
The firm had imported Cinacalcet HCl raw material
vide invoice no. 9100016098 dated 21/02/2019 from
M/s.Ind-Swift Laboratories, India and got DRAP
approval vide letter No. 5114/2018 DRAP dated 13-
04-2018.
2. What was the rationale behind selecting the
particular manufacturer of API?
The firm informed that they selected M/s. Ind-Swift
Laboratories, India based on their vendor evaluation
mechanism.
3. Do you have documents confirming the import of
reference standard and impurity standards?
The firm’s representative informed that they had
imported Cinacalcet HCl working standard and
impurities standards from API supplier. However,
firm did not have import NOC for the same.
4. Do you have certificate of Analysis of the API,
reference standards and impurity standards?
The firm had certificates of analysis for API, working
standard and impurities standards for impurity A, B,
I, J, K and L.
5. Do you have GMP certificate of API
manufacturer issued by regulatory authority of
country of origin?
The firm had provided valid GMP Certificate of
M/s.Ind Swift Laboratories, India issued by Food &
Drugs Administration, Punjab, India, valid till 27-11-
2019.
6. Do you use API manufacturer method of testing
for testing API?
The firm used API manufacturer’s method of testing.
However, firm had not tested the related substances
in the API.
7. Do you have stability studies reports on API? The firm had stability studies reports on APIs of raw
material manufacturers.
8. If yes, whether the stability testing has been
performed as per SIM method and degradation
products have been quantified?
No.
9. Do you have method for quantifying the
impurities in the API?
The firm had testing method to quantify the
impurities as provided by raw material manufacturer.
10. Do you have some remaining quantities of the
API, its reference standard and impurities
standards?
The firm had some remaining quantities of the
working standard and impurities standards.
11. Have you used pharmaceutical grade excipients? The firm had used pharmaceutical grade excipients
including Starch 1500, Avicel pH 102, Kollidon K-
30, Kollidon CL, Aerosil-200Magnesium stearate,
Opadry AMB Green.
12. Do you have documents confirming the import of
the used excipients?
The firm had necessary documents confirming the
import of the used excipients.
13. Do you have test reports and other records on the
excipients used?
The firm had Certificates of Analysis of the
excipients used.
14. Do you have written and authorized protocols for
the development of Cinacalcet HCl Tablets?
The firm had written and authorized protocols for the
development of CensiparTablet 30mg and Censipar
Tablet 60mg.
15. Have you performed Drug-excipient
compatibility studies?
The firm had performed drug-excipients
compatibility studies under stress conditions of 60oC
± 2oC / 75% ± 5% RH.
16. Have you performed comparative dissolution
studies?
The firm had performed comparative dissolution
studies for Censipar Tablet 60mg with Mimpara
Tablet 60mg, manufactured by M/s. Amgen,
Minutes of 294th Meeting of Registration Board | 83
USAusing eight basket dissolution apparatus (708-
DS by Agilent.
17. Do you have product development (R&D)
section
The firm had product development (R&D) section.
18. Do you have necessary equipment available in
product development section for development of
Cinacalcet HCl Tablets?
Product development section had necessary
equipment to develop CensiparTablets.
19. Is the equipment in product development section
qualified?
The available equipment in product development
section was qualified.
20. Do you have proper maintenance / calibration /
re-qualification program for the equipment used
in PD section?
The firm had proper maintenance / calibration / re-
qualification program for the equipment used in
product development section.
21. Do you have qualified staff in product
development section with proper knowledge and
training in product development?
Yes.
22. Have you manufactured three stability batches
for the stability studies of Cinacalcet HCl Tablets
as required?
The firm had manufactured three stability batches for
the stability studies of CensiparTablets (30mg and
60mg) with batch numbers i.e. CNA-T2-18, CNA-
T3-18, CNA-T4-18 for 30mg strength and CNB-T2-
18, CNB-T3-18,CNB-T4-18 for 60mg strength.
The accelerated studies were done in Climatic test
chamber (Model: HPP-749; Making Memmert,
Germany) and long-term studies were done in
Climatic test chamber (Model: HPP-750, Making
Memmert, Germany).
23. Do you have any criteria for fixing the batch size
of stability batches?
The firm had followed in-house SOP for fixing the
batch size of stability batches in the light of DRAP
guidelines.
24. Do you have complete record of production of
stability batches?
The firm had record of production of stability
batches.
25. Do you have protocols for stability testing of
stability batches?
The firm had protocols for stability testing of stability
batches.
26. Do you have developed and validated the method
for testing of stability batches?
The firm had developed method of Censipar Tablet
30mg (RD-PTM-08 A)& CensiparTablet 60mg (RD-
PTM-09 A) and validated the test method (CCL-
AMVR-213)for testing ofstability batches.
27. Do you have method transfer studies in case
when the method of testing being used by your
firm is given by any other lab?
Not Applicable.
28. Do you have documents confirming the
qualification of equipment / instruments being
used in the test and analysis of Cinacalcet HCl
API and the finished drug?
The firm had proper documents confirming the
qualification of equipment / instruments being used in
the test and analysis of CinacalcetHCl API and the
finished drug.
29. Do your method of analysis stability indicating? The firm had conducted stress testing of finished
product.
30. Do your HPLC software 21CFR Compliant? API testing, FPP testing and compatibility testing
had been conducted on HPLCs(Agilent 1260
&Infinity II, USA) which were not 21 CFR compliant.
However, the firm had procured 21 CFR part 11
compliant HPLC.
Minutes of 294th Meeting of Registration Board | 84
31. Can you show Audit trail reports on Cinacalcet
HCl testing?
The audit trail was not enabled. However, log of
data was available in the HPLCs. The data was also
checked through hard copies of chromatograms.
32. Do you have some remaining quantities of
degradation products and stability batches?
The firm had remaining quantities of stability batches
kept on stability testing.
33. Do you have stability batches kept on stability
testing?
The firm had stability batches kept on stability
testing.
34. Do you have valid calibration status for the
equipment used in CinacalcetHCl tablets
production and analysis?
The firm had valid calibration status for the
equipment used in Censipar Tablets production and
analysis.
35. Do proper and continuous monitoring and control
are available for stability chamber?
Adequate monitoring and control was available for
stability chamber. The firm was advised to improve
the alarm system.
36. Do related manufacturing area, equipment,
personnel and utilities be rated as GMP
compliant?
Requisite facilities were satisfactory and GMP
compliant (DRAP ref. no. 118/2019-DRAP (AD-
789112-762) dated 13-05-2019).
Clarification:
(i) The firm had performed content uniformity of dosage unit on stability batches and incorporated the test
for content uniformity in Product Test Method.
(ii) The firm had revised the value of Q=75% in Product Test Method and Stability Studies Protocol.
REMARKS:
Based on the area inspected, the technical personnel met and the documents reviewed, and considering the
findings of inspection, it seems that M/s. CCL Pharmaceuticals (Pvt.) Ltd., at 62 Industrial Estate, Kot Lakhpat,
Lahore, Pakistan have conducted stability studies of the following products:
Sr. No. Name / Composition of Drugs
01 Censipar Tablet 30mg
Each film coated tablet contains:
Cinacalcet (as HCl)………………………30mg
02 Censipar Tablet 60mg
Each film coated tablet contains:
Cinacalcet (as HCl)………………………60mg
Remarks of Evaluator:
The panel has reported following with respect to documents confirming the import of Cinacalcet HCl including
approval from DRAP:
“The firm had imported Cinacalcet HCl raw material vide invoice no. 9100016098 dated 21/02/2019 from M/s
Ind-Swift Laboratories, India and got DRAP approval vide letter No. 5114/2018 DRAP dated 13-04-2018.”
While the invoice submitted in PEC has same invoice number but is dated 21-02-2018. Also the quantity
mentioned in submitted invoice is 225gm while the required quantity for production of three batches (2000 tablets
each) of Cinacalcet 30mg & 60mg tablets is approximately 590gms.
Proceedings: The Registration Board was apprised that the panel has identified the above cited variation in the
date of commercial invoice as drafting error, moreover firm has presented another invoice (Invoice# 9100017019
dated 03-03-2018) for the import of 575gm of Cinacalcet HCl, while this invoice was not attested by DRAP office.
Decision of 293rd meeting: Registration Board deferred the applications of Censipar 30mgtablet & Censipar
60mg tablet for seeking clarification from the applicant regarding the import of 575gm of Cinacalcet vide Invoice#
9100017019 dated 03-03-2018, without prior approval of DRAP office.
Reply of firm:
“Initially CCL planned to develop Censipar tablet 30mg (Cinacalcet HCl) only and accordingly imported 225gm
vide invoice no. 9100016098 dated 21-02-2018 and the same was released by Assistant Director I7E, DRAP,
Lahore vide letter no. 5114/2018 DRAP dated 13-04-2018.
Later on our Marketing department also requested for Censipar tablet 60mg (Cinaclacet HCl) so we arranged
further said material i.e., 575gm vide invoice no. 9100017019 dated 03-03-2018 through Fed EX and missed the
approval of Assistant Director I&E, DRAP, Lahore.
Minutes of 294th Meeting of Registration Board | 85
We apologise for partial compliance of DRAP instructions & commit to comply with true letter & spirit in future.”
Upon inquiring about online verification of the FedEx shipment, the firm responded as under:
“We have contacted requested to FedEx to verify attached Fed Ex airway bill dated 10-03-2018 & fed Ex informed
that said shipment cant be tracked after 90days.”
Decision: Registration Board decided to approve registration of Censipar (Cinacalcet as HCl)
Tablet 30mg and Censipar (Cinacalcet as HCl) Tablet 60mg with Innovator’s specifications by
M/s CCL Pharmaceuticals (Pvt.) Ltd., at 62 Industrial Estate, Kot Lakhpat, Lahore.
Manufacturer will place first three production batches of both products on long term stability
studies throughout proposed shelf life and on accelerated studies for six months.
Sr.
No.
Name & Address of
Manufacturer /
Applicant
Brand Name
(Proprietary Name + Dosage Form
+ Strength), Composition,
Pharmacological Group,
Finished Product Specification
Type of Form,
Initial Diary &
Date, Fee (including
differential fee),
Demanded Price /
Pack size
International Availability /
Local Availability
GMP Inspection Report
Date & Remarks
81. M/s Scilife Pharma
(Pvt.) Ltd
Plot FD-57/58-A2
Korangi Creek
Industrial Park
Karachi
Eflozin-M 12.5/500 mg Tablet
"Each Film Coated Tablet
Contains:
Empagliflozin .…12.5mg
Metformin HCl …… 500mg"
(Anti-diabetic)
(Mfg. Specs)
Form 5-D
Dy. No 37404
12-11-2018
Rs.50,000/-
12-11-2018
Rs.50,000/-
As per PRC
Approved by USFDA
82. M/s Scilife Pharma
(Pvt.) Ltd
Plot FD-57/58-A2
Korangi Creek
Industrial Park
Karachi
Eflozin-M 12.5/1000 mg Tablet
"Each Film Coated Tablet
Contains:
Empagliflozin .…12.5mg
Metformin HCl …… 1000mg"
(Anti-diabetic)
(Mfg. Specs)
Form 5-D
Dy. No 37406
dated 12-11-2018
Rs.50,000/- Dated
12-11-2018
Rs.50,000/-
As per PRC
Approved by USFDA
REQUEST OF EXEMPTION ROM ON SITE INSPECTION
The firm has requested for Exemption from On-site Investigation of their submitted stability data and provided
the following documents in conjunction with the checklist approved by the Registration Board in its 278th Meeting:
Administrative Portion
1. Reference of last onsite panel
inspection for instant dosage form
conducted during last two years.
Registration Board approved Eflozin 10 & 25mg tablets in its 292nd
Meeting.
Date of Inspection: 27th September, 2019 (Morning).
The HPLC software is 21CFR Compliant as per record of firm.
Audit trail reports were available and randomly checked.
2. Documents for the procurement of
API with approval from DRAP (in
case of import).
Empagliflozin
i. Copy of Form 6 (License to Import drug) issued by Licensing
Authority (Karachi) dated 11-06-2018, for the import of
Empagliflozin from the M/s Zhejiang Hongyuan
Pharmaceutical Co., Ltd, Chem & API’s Industrial Zone,
Linhai, Zhejiang province, China has been submitted.
ii. Copy of Commercial Invoice
Invoice no. 30180190
Attested by Assistant Director (I&E) DRAP (Karachi) dated 11-06-
2018.
Batch No 20180401.
Quantity: 1 Kg
Metformin HCl
Minutes of 294th Meeting of Registration Board | 86
Copy of Form 6 (License to Import drug) issued by Licensing
Authority (Karachi) dated 23-12-2016, for the import of
Metformin HCl from the M/s Aarti Drugs Ltd. (Unit-II) Plot No.
211-213 Road No.2 Char Rasta GIDC Sarigma India. has been
submitted.
Copy of Commercial Invoice
Invoice no. 30180190
Attested by Assistant Director (I & E) DRAP (Karachi) dated 11-06-
2018.
Batch No 20180401.
Quantity: 1 Kg
3. Documents for the procurement of
reference standard and impurity
standards.
Empagliflozin
Copy of GMP certificate issued by Taizhuo Drug Administration to the
M/s Zhejiang Hongyuan Pharmaceutical Co., Ltd, Chem & API’s
Industrial Zone, Linhai, Zhejiang province, China valid upto 21-09-
2022.
Metformin HCl
Copy of GMP certificate issued by Food & Drugs Control
Administration to the M/s Aarti Drugs Ltd. (Unit-II) Plot No. 211-213
Road No.2 Char Rasta GIDC Sarigma India valid upto 09-01-2020.
4. Approval of API/ DML/GMP
certificate of API manufacturer
issued by regulatory authority of
country of origin.
Empagliflozin
The firm has provided copy of GMP certificate
(Certificate#ZJ20180032) issued by China Food & Drug
Administration for M/s Zhejiang Hongyuan Pharmaceutical Co., Ltd.
Valid Up to 14-03-2023.
Metformin HCl
Copy of GMP certificate issued by Food & Drugs Control
Administration to the M/s Aarti Drugs Ltd. (Unit-II) Plot#211-213
Road No.2 Char Rasta GIDC Sarigma India valid upto 09-01-2020.
5. Mechanism for Vendor pre-
qualification
The firm has submitted Memorandum Of Vendor Approval for both
APIs.
6. Certificate of analysis of the API,
reference standards and impurity
standards
Empagliflozin
API Batch. #
Empagliflozin 20180401
Empagliflozin WS 20180501WS
Empagliflozin WS 20180702WS
Impurity A IMPA20190107
Impurity C IMPC20190110
Metformin HCl
API Batch. #
Metformin HCl MEF/16111159
Metformin HCl Primary
reference standard
USP Lot No. R069H0
7. Documents for the procurement of
excipients used in product
development?
The firm has submitted commercial invoices & COAs of excipients
used in formulation from relevant manufacturers.
8. List of qualified staff involved in
product development with relevant
experience.
The firm has submitted copy of List of qualified staff along with their
training record involved in Research & Development.
Minutes of 294th Meeting of Registration Board | 87
Production Data
9. Authorized Protocols/SOP for the
development & stability testing of
trial batches.
The firm has submitted SOP of Product development and protocol for
stability studies specific to the product.
10. Complete batch manufacturing
record of three stability batches.
The firm has submitted copy of Batch Manufacturing Record and batch
packaging record of the following 03 Batches.
Eflozin-M 12.5/1000mg Tablet
Batch#: Batch size Mfg. date
135B18 500 tablets 07-2018
148B18 500 tablets 08-2018
149B18 500 tablets 08-2018
Eflozin-M 12.5/500mg Tablet
134B18 1000 tablets 07-2018
146B18 1000 tablets 08-2018
147B18 1000 tablets 08-2018
11. Record of remaining quantities of
stability batches. Description B.No:
135B18
B.No: 148B18
B.No: 149B18
Theoretical Batch
Size
500
tablets
500
tablets
500
tablets
Total produced 450 459 423
Kept On
30°C/RH75%
280 280 280
Kept On
40°C/RH75%
112 112 112
Remaining On
30° C/RH75%
154 154 154
Remaining On
40° C/RH75%
- - -
Total used for CDP 36 -
Remaining quantities
in R&D
28 N/A N/A
QA / QC DATA
12. Record of Digital data logger for
temperature and humidity
monitoring of stability chambers
(real time and accelerated)
Tabular record of Digital data logger for temperature and humidity
monitoring of stability chambers has been submitted.
13. Method used for analysis of API
along with COA.
Firm has provided copies of Method of analysis and COAs for both
APIs
14. Method used for analysis of FPP &
complete record of testing of
stability batches (i.e.
chromatograms, lab reports, raw
data sheets etc.)
The firm has submitted copy of Finished Product specification &
Test method.
Firm has submitted complete record of testing of stability batches
(i.e. chromatograms, lab reports, raw data sheets etc.)
15. Reports of stability studies of API
from manufacturer. Empagliflozin
The firm has submitted copies of reports of 06 Months Accelerated and
12 Months Real Time Stability Study Data of 03 Batches of API as per
Zone-IVA conditions
Metformin HCl
The firm has submitted copies of reports of 06 Months Accelerated and
60 Months Real Time Stability Study (30oC+2 oC, 65+5%) Data of 03
Batches of API.
Minutes of 294th Meeting of Registration Board | 88
16. Analysis reports for excipients
used.
The firm has submitted copies of its own Analytical reports for all
excipients used in product development.
17. Drug-excipients compatibility
studies.
Firm has not performed drug excipient compatibility studies as they
claim their qualitative composition is same as that of the innovator.
18. Record of comparative dissolution
data.
Firm has submitted protocol for comparative dissolution at pH 1.2, pH
4.5 and pH 6.8. The details of reference product & Sample product are
as follows: Feature Reference product Product of M/s
Scilife
Brand name Synjardy
12.5+1000mg tablet
Eflozin-M2.5/1000mg
tablet
Batch No. 744630 148B18
Exp. Date 06-2020
Feature Reference product of
Hilton pharma
Product of M/s
Scilife
Brand name Xenglumet
12.5/50012.5+500mg tablet
Eflozin-M2.5/500mg
tablet
Batch No. 131255 146B18
Exp. date 07-2021
F2 factor calculation is within acceptable range.
19. Compliance Record of HPLC
software 21CFR & audit trail
reports on product testing.
Firm has submitted audit trail reports for complete stability studies
analysis of three batches.
Remarks of Evaluator:
Significant change in the Assay results of various batches have been reported in the submitted data of
accelerated stability studies, detailed as under: Product Batch# API Assay value at
Initial time point
Significant change value
Eflozin-M
12.5/1000mg tablet
148B18 Empagliflozin 98.13% 106.05% (at 6th month
time point)
Eflozin-M
12.5/1000mg tablet
149B18 Metformin HCl 101.95% 96.775 (at 6th month
time point)
Justification shall be submitted for above reported significant changes for the grant of 2 years shelf life.
Firm’s response for Empagliflozin:
1. Batch number "149B18" showing the 5.18% difference in assay value which is slightly higher (0.18%)
from the initial time point while the rest of the batches "135B18" and "148B18" showing the satisfactory
insignificant change values 1.78% and 0.94% respectively.
2. Average results of each individual batch up to 6 month stability 99.65%, 98.43% and 100.16% which are
well within the limit having all values between 90% and 110% as a shelf life limit.
3. We have manufactured all the batches at 100% potency no results obtained at lower side less than 95%
which is satisfactory.
4. The consideration of the slightly lower results in one of the batch at 6 month at this stage while the results
are within limit between 90% - 110%
5. The results obtained at every time point of every batch well within shelf limit of 90% - 110% so consider
satisfactory and the only one result of one batch at single time point slightly lower so that could be considered
insignificant in general if we look the picture in broader way.
6. The 9 months at real time condition also completed and found satisfactory results which are 149B18=
96.94%, 135B18=96.66% and 97.90% for Metformin HCl well within the limit.
7. On the basis of above discussion and statistical evaluation the results need to be considered satisfactory
and reveals that the product will remains safe, effective and quality medicine and stable till 2 years shelf life.
Firm’s response for Metformin HCl:
Minutes of 294th Meeting of Registration Board | 89
1. Batch number "149B18" showing the 5.18% difference in assay value which is slightly higher (0.18%) from
the initial time point while the rest of the batches "135B18" and "148B18" showing the satisfactory insignificant
change values 1.78% and 0.94% respectively.
2. Average results of each individual batch up to 6 month stability 99.65%, 98.43% and 100.16% which are well
within the limit having all values between 90% and 110% as a shelf life limit.
3. We have manufactured all the batches at 100% potency no results obtained at lower side less than 95% which
is satisfactory.
4. The consideration of the slightly lower results in one of the batch at 6 month at this stage while the results are
within limit between 90% - 110%
5. The results obtained at every time point of every batch well within shelf limit of 90% - 110% so consider
satisfactory and the only one result of one batch at single time point slightly lower so that could be considered
insignificant in general if we look the picture in broader way.
6. The 9 months at real time condition also completed and found satisfactory results which are 149B18= 96.94%,
135B18=96.66% and 97.90% for Metformin HCl well within the limit.
7. The obtained results shows that the batch to batch and within batch variation which is acceptable because within
the limit 90-110% rather significant change however it will be further controlled and improved in future on full
scale validation.
8. On the basis of above discussion and statistical evaluation the results need to be considered satisfactory and
reveals that the product will remains safe, effective and quality medicine and stable till 2 years shelf life.
Decision of 293rd meeting: Registration Board deferred for further deliberation in light of above points.
Remarks of evaluator: Now the firm has submitted long term stability studies data of three batches each for both
Eflozin-M 12.5/1000mg tablet & Eflozin-M 12.5/500 mg Tablet till 12 month time point, wherein the results for
both Assay & Dissolution test are within the limits.
Decision: Registration Board decided to approve registration of Eflozin-M 12.5/500mg tablet &
Eflozin-M 12.5/1000 mg Tablet with Innovator’s specifications by M/s Scilife Pharma (Pvt.) Ltd
Plot FD-57/58-A2 Korangi Creek Industrial Park Karachi. Manufacturer will place first three
production batches of both products on long term stability studies throughout proposed shelf life
and on accelerated studies for six months.
b. Exemption from onsite verification of stability data 83. Name and address of manufacturer /
Applicant
M/s Getz Pharma Pvt. Ltd., Karachi
Brand Name +Dosage Form + Strength Glardin-M Tablets 5mg + 850mg
Composition Each film coated tablet contains:-
Empagliflozin …….5mg
Metformin HCl ….. 850mg
Diary No. Date of R& I & fee Dy. No 380 dated 18-03-2016, Rs.50,000/-
Pharmacological Group Anti-diabetic
Type of Form Form 5D
Finis`hed product Specifications Manufacturer specifications
Pack size & Demanded Price As per PRC
Approval status of product in
Reference Regulatory Authorities
Approved by EMA
Me-too status (with strength and
dosage form)
GMP status
Remarks of the EvaluatorII
84. Name and address of manufacturer /
Applicant
M/s Getz Pharma Pvt. Ltd., Karachi
Brand Name +Dosage Form + Strength Glardin-M Tablets 5mg + 1000mg
Composition Each film coated tablet contains:-
Empagliflozin …. 5mg
Metformin HCl ….. 1000mg
Minutes of 294th Meeting of Registration Board | 90
Diary No. Date of R& I & fee Dy. No 378 dated 18-03-2016, Rs.50,000/-
Pharmacological Group Anti-diabetic
Type of Form Form 5D
Finis`hed product Specifications Manufacturer specifications
Pack size & Demanded Price As per PRC
Approval status of product in
Reference Regulatory Authorities.
Approved by EMA
Me-too status (with strength and
dosage form)
GMP status
Remarks of the EvaluatorII
Now the firm has requested for Exemption from On-site Investigation of their submitted stability data of Glardin-
M tablet range tablets and provided the following documents in conjunction with the checklist approved by the
Registration Board in its 278th Meeting:
Administrative Portion
1. Reference of last onsite panel
inspection for instant dosage form
conducted during last two years.
Firm has referred to onsite inspection report of their product “Arcox
(Etoricoxib) 90mg & 120mg”, which was conducted on 17th
September, 2018 and was presented in 286th meeting of Registration
Board held on 14-16th November, 2018.
Registration Board decided to approve registration of “Arcox
(Etoricoxib) 90mg & 120mg” by M/s Getz Pharma.
Following two observations were reported in the report:
i. The HPLC software is 21 CFR compliant as per record available
with the firm.
ii. Audit trail on the testing reports is available.
iii. Adequate monitoring and control are available for stability
chamber.
2. Documents for the procurement of
API with approval from DRAP (in
case of import).
Commercial invoice for Metformin Hydrochloride as per following
details Batch No. Invoice No. Quantity
Imported.
Date of approval by
DRAP
MT18731217
MT18741217
MT18751217
EXP/92001
511/1-7-18
500Kg 16-01-2018
Commercial invoice for Empagliflozin as per following details Batch
No.
Invoice#. Quantity
Imported.
Date of approval by
DRAP
20171108 CAVIR-
20171001AP
4Kg 23-11-2017
3. Documents for the procurement of
reference standard and impurity
standards.
Empagliflozin:
Firm has submitted copy of commercial invoices from M/s Jiangsu
Yongan Pharmaceutical Co., ltd. China for the following reference
standards:
Reference Std. Batch# Quantity
Empagliflozin 20170303 10mg
Empagliflozin Impurity A EPG-ZA-160404 10mg
Empagliflozin Impurity B EPG-ZB-160408 10mg
Metformin HCl:
Firm has submitted copy of commercial invoices from M/s Lab
Sciences for the import of Metformin HCl 200mg USP reference
standard Cat# 1396309.
Minutes of 294th Meeting of Registration Board | 91
4. Approval of API/ DML/GMP
certificate of API manufacturer
issued by regulatory authority of
country of origin.
Empagliflozin:
The firm has provided copy of GMP certificate (Certificate#
JSHAHAQ2017005) issued by Huaian Market Supervision
Administration in the name of M/s Jiangsu Yongan Pharmaceutical
Co., Ltd. China Valid Up to 31-12-2020.
Metformin HCl: Copy of GMP certificate issued by DCA Andhra
Pradesh, India, issued for M/s Wanbury ltd., West Godavari District,
Andhra Pradesh, India issued on 06-02-2019.
5. Mechanism for Vendor pre-
qualification
The firm has submitted copy of Vendor Audit Questionnaire filled for
both Empagliflozin & Metformin HCl.
6. Certificate of analysis of the API,
reference standards and impurity
standards.
The firm has submitted certificate of analysis for API
& reference standards for both APIs.
7. Documents for the procurement of
excipients used in product
development?
The firm has submitted copy of Purchase Order/Invoices for the
procurement of excipients used in product development
8. List of qualified staff involved in
product development with relevant
experience.
The firm has submitted copy of List of qualified staff involved in
product development & scientific Development and Analytical
services comprising of 19 technical members.
Production Data
9. Authorized Protocols/SOP for the
development & stability testing of
trial batches.
The firm has submitted authorized copy of Product Development
Protocol & Stability protocols for applied products.
10. Complete batch manufacturing
record of three stability batches.
The firm has submitted copy of Batch Manufacturing Record and
Batch Packaging Record of three stability batches for the stability
studies of Empagliflozin + Metformin HCl tablet range such as. Empagliflozin/Metformin HCl (5mg + 1000mg Tablet)
Batch No. Date of Mfg. Batch Size
446DS01 09-2018 1500 Tablets
446DS02 09-2018 1500 Tablets
446DS03 09-2018 1500 Tablets
Empagliflozin/Metformin HCl (5mg + 850mg Tablet)
Batch No. Date of Mfg. Batch Size
11. Record of remaining quantities of
stability batches.
The firm has submitted reconciliation sheet mentioning details of the
remaining quantities of tablets kept at accelerated and real time
stability studies.
QA / QC DATA
12. Record of Digital data logger for
temperature and humidity
monitoring of stability chambers
(real time and accelerated)
The firm has submitted photocopies of digital printouts of graphical
charts for Real Time and Accelerated Conditions for complete stability
studies of applied formulations.
13. Method used for analysis of API
along with COA.
The firm has submitted copy of raw material specifications, raw
material testing procedures and report for Empagliflozin & Metformin
hydrochloride.
14. Method used for analysis of FPP &
complete record of testing of
stability batches (i.e.
chromatograms, lab reports, raw
data sheets etc.)
The firm has submitted copy of Specification/Testing Method of
Finished Product for Glardin-M 5/1000 & 5/850 tablets along with
Stability Study Report of stability batches & chromatograms, lab
reports, raw data sheets etc. for both strengths of applied formulation.
15. Reports of stability studies of API
from manufacturer.
The firm has submitted stability studies reports on Empagliflozin and
Metformin HCl.
Minutes of 294th Meeting of Registration Board | 92
16. Analysis reports for excipients
used.
The firm has submitted photocopies of its own Analytical reports for
all excipients used in product development of Emazin-M tablet range.
17. Drug-excipients compatibility
studies. The firm has stated that they have similar qualitative formulation
as that of the innovator product.
18. Record of comparative dissolution
data. Firm has submitted results for comparative dissolution results in
against the reference product “Synjardy tablet 12.5/850mg for
both the applied strength.
Dissolution results were above 85% in 15 minutes for both
reference and sample product.
19. Compliance Record of HPLC
software 21CFR & audit trail
reports on product testing.
Firm has submitted method audit trail reports of stability
studies of applied formulations.
Remarks of Evaluator:
This is to bring to your kind attention that our Empagliflozin + Metformin HCl tablets 5+850, 5+1000
& 12.5+850 are dose proportional in accordance with EMA guidelines on the investigation of Bioequivalence.
In view of the said guidelines we have benchmarked Synjardy tablets 12.5mg + 850mg as reference product for
all the strengths.
Discussion: Registration Board deliberated on the response of the firm and reiterated that the applicability of
biowaiver for an individual strength of a formulation applies in those conditions where bioequivalence have been
studied on the highest and lower strengths and is also not applicable for CDP. The Board further deliberated that
as the performance of Comparative Dissolution Profile (CDP) is optional for applications on Form 5D but is
mandatory for Form 5F.
Decision: Registration Board decided to approve registration of Glardin-M Tablets 5mg + 850mg
& Glardin-M Tablets 5mg + 1000mg by M/s Getz Pharma Pvt. Ltd., Karachi with Innovator’s
specifications. Manufacturer will place first three production batches of both products on long
term stability studies throughout proposed shelf life and on accelerated studies for six months.
Sr.
No.
Name &
Address of
Manufacturer /
Applicant
Brand Name
(Proprietary Name + Dosage
Form + Strength),
Composition,
Pharmacological Group,
Finished Product Specification
Type of Form,
Initial Diary &
Date, Fee
(including
differential fee),
Demanded Price /
Pack size
International
Availability / Local
Availability
GMP Inspection
Report Date &
Remarks
Previous
DRB
Decision /
Remarks
(if any)
85. Genix Pharma
(Pvt.) Ltd.
Karachi
Vortex Tablets 5mg
Each film coated tablet
contains: -
Vortioxetine
Hydrobromide………5mg
(Innovator’s Specifications)
Form 5D
18-04-2017,
Fee: 50,000/-
As per SRO
Approved by USFDA
Firm is operating
at acceptable
level of GMP
compliance as per
inspection dated
10-04-2019
-
STABILITY STUDY DATA
Drug Vortex 5mg tablets
Name of Manufacturer Genix Pharma (Pvt.) Ltd.
Manufacturer of API M/s Jiangsu Yongan Pharmaceutical Co., Ltd. No. 18,237 provincial
highway, Jiangsu Huaian Economic development Zone, China
API Lot No. 3804-201803001
Description of Pack
(Container closure system) Alu-Alu Blister Pack
Stability Storage Condition Accelerated: 40°C ± 2°C / 75% ± 5%RH
Minutes of 294th Meeting of Registration Board | 93
Real Time: 30°C ± 2°C / 65% ± 5%RH
Time Period Accelerated: 06 months
Real Time: 12 months
Frequency Accelerated: 0, 1, 2,3,4 & 6 (Months)
Real Time: 3,6, 9 , 12 (Months)
Batch No. 18SB-118-01 18SB-119-02 18SB-120-03
Batch Size 1500 Tablets 1500 Tablets 1500 Tablets
Manufacturing Date 07-2018 07-2018 07-2018
Date of Initiation 07-2020 07-2020 07-2020
No. of Batches 03
DOCUMENTS / DATA PROVIDED BY THE APPLICANT INITIALLY
Documents to Be Provided Status
COA of API Yes
Approval of API by regulatory authority of country
of origin or GMP certificate of API manufacturer
issued by regulatory authority of country of origin.
Yes
Protocols followed for conduction of stability study
and details of tests. Yes
Data of 03 batches will be supported by attested
respective documents like chromatograms,
laboratory reports, data sheets etc.
Yes
Documents confirming import of API etc.
Copy of Form 6 (License to Import drug for clinical
trial examination, test or analysis) issued by
Assistant Director (I & E) DRAP (Karachi) dated
16-03-2018, for the import of Vortioxetine
hydrobromide (300g) from the M/s Suzhou Zhiyu
Biotechnology Co, Ltd., Manufactured by
M/sJiangsu Yongan Pharmaceutical Co. Ltd.,
China has been submitted.
Copy of Commercial Invoice (invoice no.
ZY18031601G/W) dated attested by Assistant
Director (I & E) DRAP (Karachi) dated 09-04-
2018 has been submitted.
All provided documents will be attested (name, sign
and stamp) for ensuring authenticity of data /
documents.
Yes
Commitment to continue real time stability study till
assigned shelf life of the product. Yes
Commitment to follow Drug Specification Rules,
1978. Yes
REMARKS OF EVALUATOR
(AD PEC-I)
The firm has provided 06 Months Accelerated and 12 Months Real Time Stability Data for 03 Lab Scale
Batches.
REQUEST OF EXEMPTION FROM ON SITE INSPECTION
Now the firm has requested for Exemption from On-site Investigation of their submitted stability data vide
Letter no. RA/224/19, dated 12-12-2019 and provided the following documents in conjunction with the
checklist approved by the Registration Board in its 278th Meeting:
Minutes of 294th Meeting of Registration Board | 94
Administrative Portion
1.
Reference of last onsite panel
inspection for instant dosage
form conducted during last two
years.
Firm has referred to onsite inspection report of their product “WYMLY
Tablets 25mg (Tenofovir Alafenamide)”, which was conducted on 06-
02-2018, and was presented in 281st meeting of Registration Board held
on 11-13th April, 2018.
Registration Board decided to approve registration of WYMLY Tablets
25mg (Tenofovir Alafenamide)”, by M/s. Genix Pharma (Pvt.) Ltd.,
Karachi. Manufacturer will place first three production batches on long
term stability studies throughout proposed shelf life and on accelerated
studies for 26 weeks.
Following two observations were reported in the report:
i. The HPLC software is 21CFR complaint and having certificates of
compliance by USFDA.
ii. Audit trail on the testing reports of WYMLY Tablets 25mg (Tenofovir
Alafenamide) is available.
iii. Adequate monitoring and control are available for stability chamber.
Chamber are controlled and monitored through software having alarm
system for alerts as well.
2.
Documents for the procurement
of API with approval from
DRAP (in case of import).
Copy of Commercial Invoice (invoice no. ZY18031601G/W) dated
attested by Assistant Director (I & E) DRAP (Karachi) dated 09-04-2018
has been submitted for the batch number 3804-201803001.
3.
Documents for the procurement
of reference standard and
impurity standards.
The firm has submitted copy of letters from
M/s Neon chemicals, in the name of M/s Genix Pharma (Pvt.) Ltd,
Karachi,
Particulars Batch no Qty
Vortioxetine hydrobromide 3804-201802001 (W/S) 3 gm
4.
Approval of API/ DML/GMP
certificate of API manufacturer
issued by regulatory authority of
country of origin.
Copy of GMP certificate (Certificate# JS 20160548) issued by Jiangsu
FDA in the name of M/s Jiangsu Yongan Pharmaceutical Co., Ltd, valid
upto 03-03-2021 has been submitted.
5.
Mechanism for Vendor pre-
qualification
The firm has submitted copy of “SOP for Selection of manufacturer for
API/Excipient and Procurement Procedure”,
SOP No: QA/SOP/SY/037 with effective date 07-10-2016.
Version no: 01
Copy of “Vendor’s Audit form” filled for M/s Jiangsu Yongan
Pharmaceutical Co. Ltd Co., Ltd, China.
6.
Certificate of analysis of the
API, reference standards and
impurity standards
Copy of COAs of Vortioxetine hydrobromide, working standards issued
by M/s Jiangsu Yongan Pharmaceutical Co. Ltd .is submitted. Detail is
as under
Particulars Batch no Quantity
Vortioxetine
hydrobromide
3804-201803001 300gm
Vortioxetine
hydrobromide
3804-201802001
(W/S)
3 gm
7.
Documents for the procurement
of excipients used in product
development?
The firm has submitted copy of Purchase Order/Invoices for the
procurement of excipients used in product development
8.
List of qualified staff involved
in product development with
relevant experience.
The firm has submitted copy of List of qualified staff involved in product
development & regulatory affairs comprising of 4 members.
Minutes of 294th Meeting of Registration Board | 95
Production Data
9.
Authorized Protocols/SOP for
the development & stability
testing of trial batches.
The firm has submitted copy of Development Protocol for Lab scale
batch manufacturing of Vortex Tablets 5mg, 10mg, 15mg and 20mg. The
SOP mentions the details of master formulation & manufacturing method
for both Vortex Tablets 10mg,15mg and 20mg. Copies of stability
protocols have also been submitted for Vortex Tablets 5mg
10.
Complete batch manufacturing
record of three stability batches.
The firm has submitted copy of Batch Manufacturing Record and Batch
Packaging Record of the following 03 Batches:
BATCH NO BATCH SIZE MFG DATE
18SB-118-01 1500 Tablets 07-2018
18SB-119-02 1500 Tablets 07-2018
18SB-120-03 1500 Tablets 07-2018
11.
Record of remaining quantities
of stability batches.
The firm has attached Record of remaining quantities of stability batches.
QA / QC DATA
12.
Record of Digital data logger
for temperature and humidity
monitoring of stability
chambers (real time and
accelerated)
The firm has submitted photocopies of digital record for Real Time and
Accelerated Conditions starting from 01-06-2018 to 31-08-2019.
13.
Method used for analysis of API
along with COA.
The firm has submitted copy of raw material specifications, raw material
testing procedures and report for Vortioxetine Hydrobromide (batch #
3804-201803001) along with COAs for Vortioxetine hydrobromide from
M/s Jiangsu Yongan Pharmaceutical Co. Ltd., China
14.
Method used for analysis of FPP
& complete record of testing of
stability batches (i.e.
chromatograms, lab reports, raw
data sheets etc.)
The firm has submitted copy of Finished Product Testing Procedure (QC-
FPNS-142 issued on 18-07-2018) for Vortex 5mg Tablet along with
Stability Study Report of stability batches.
15.
Reports of stability studies of
API from manufacturer.
The firm has submitted copy of 06 Months Accelerated and 12 Months
Real Time Stability Study (30oC+2 oC, 65+5%) Data of 03 Batches of
Vortioxetine from M/s Jiangsu Yongan PharmaceuticalCo. Ltd., China
16.
Analysis reports for excipients
used.
The firm has submitted photocopies of its own Analytical reports for all
excipients used in product development of Vortex tablets.
17.
Drug-excipients compatibility
studies.
The firm has not performed Drug-excipients compatibility studies and
stated that the qualitative composition of their product (Vortex Tablet) is
similar to that of innovator’s product i.e. Trintellix
Tablets and also stability studies have not shown any incompatibility or
significant degradation.
18.
Record of comparative
dissolution data.
Firm has submitted F2 factor protocol (QC/PRO/CD/30) & dated 11-
11-2019. feature Reference product Product of M/S Genix
Pharma
Brand name Trintellix tablet 5mg Vortex Tablets 5mg
Comparative dissolution studies have been performed in following
mediums:
i. pH 0.1N HCl buffer
Minutes of 294th Meeting of Registration Board | 96
ii. pH 4.5 Acetate buffer
iii. pH 6.8 Phosphate buffer
19.
Compliance Record of HPLC
software 21CFR & audit trail
reports on product testing.
Firm has submitted audit trail reports of stability studies of applied
formulation
Decision: Registration Board decided to approve registration of Vortex Tablets 5mg with
Innovator’s specifications by M/s Genix Pharma (Pvt.) Ltd. Karachi. Manufacturer will place
first three production batches on long term stability studies throughout proposed shelf life and
on accelerated studies for six months.
Sr.
No.
Name &
Address of
Manufacturer /
Applicant
Brand Name
(Proprietary Name + Dosage
Form + Strength), Composition,
Pharmacological Group,
Finished Product Specification
Type of Form,
Initial Diary &
Date, Fee
(including
differential fee),
Demanded Price
/ Pack size
International
Availability / Local
Availability
GMP Inspection
Report Date &
Remarks
Previous
DRB
Decision /
Remarks
(if any)
86. Genix
Pharma (Pvt.)
Ltd.
Karachi
Vortex Tablets 10mg
Each film coated tablet
contains: -
Vortioxetine
Hydrobromide………10mg
(Innovator’s Specifications)
Form 5D
26-12-2014,
Fee: 50,000/-
As per SRO
Approved by
USFDA. Firm is
operating at
acceptable level
of GMP
compliance as per
inspection dated
10-04-2019
-
STABILITY STUDY DATA
Drug Vortex 10mg tablets
Name of Manufacturer Genix Pharma (Pvt.) Ltd.
Manufacturer of API Jiangsu Yongan Pharmaceutical
API Lot No. 3804-201803001
Description of Pack
(Container closure system) Alu-Alu Blister Pack
Stability Storage Condition Accelerated: 40°C ± 2°C / 75% ± 5%RH
Real Time: 30°C ± 2°C / 65% ± 5%RH
Time Period Accelerated: 06 months Real Time: 12 months
Frequency Accelerated: 0, 1, 2,3,4 & 6 (Months)
Real Time: 3,6, 9 , 12 (Months)
Batch No. 18SB-121-01 18SB-122-02 18SB-123-03
Batch Size 1500 Tablets 1500 Tablets 1500 Tablets
Manufacturing Date 07-2018 07-2018 07-2018
Date of Initiation 07-2020 07-2020 07-2020
No. of Batches 03
Date of Submission 08-11-2019
DOCUMENTS / DATA PROVIDED BY THE APPLICANT INITIALLY
Documents to Be Provided Status
COA of API Yes
Minutes of 294th Meeting of Registration Board | 97
Approval of API by regulatory authority of country
of origin or GMP certificate of API manufacturer
issued by regulatory authority of country of origin.
Yes
Protocols followed for conduction of stability study
and details of tests. Yes
Data of 03 batches will be supported by attested
respective documents like chromatograms,
laboratory reports, data sheets etc.
Yes
Documents confirming import of API etc.
Copy of Form 6 (License to Import drug for
clinical trial examination, test or analysis) issued
by Assistant Director (I & E) DRAP (Karachi)
dated 16-05-2018, for the import of Vortioxetine
hydrobromide (300g) from the M/s Suzhou Zhiyu
Biotechnology Co, Ltd., Manufactured by
M/sJiangsu Yongan Pharmaceutical Co. Ltd.,
China has been submitted.
Copy of Commercial Invoice (invoice no.
ZY18031601G/W) dated attested by Assistant
Director (I & E) DRAP (Karachi) dated 16-03-
2018 has been submitted.
All provided documents will be attested (name, sign
and stamp) for ensuring authenticity of data /
documents.
Yes
Commitment to continue real time stability study till
assigned shelf life of the product. Yes
Commitment to follow Drug Specification Rules,
1978. Yes
REMARKS OF EVALUATOR (AD PEC-I)
The firm has provided 06 Months Accelerated and 12 Months Real Time Stability Data for 03 Lab Scale
Batches.
REQUEST OF EXEMPTION FROM ON SITE INSPECTION
Now the firm has requested for Exemption from On-site Investigation of their submitted stability data vide
Letter no. RA/202/19, dated 11-11-2019 and provided the following documents in conjunction with the
checklist approved by the Registration Board in its 278th Meeting:
Administrative Portion
1.
Reference of last onsite panel
inspection for instant dosage
form conducted during last two
years.
Firm has referred to onsite inspection report of their product “WYMLY
Tablets 25mg (Tenofovir Alafenamide)”, which was conducted on 06-
02-2018, and was presented in 281st meeting of Registration Board held
on 11-13th April, 2018.
Registration Board decided to approve registration of WYMLY Tablets
25mg (Tenofovir Alafenamide)”, by M/s. Genix Pharma (Pvt.) Ltd.,
Karachi. Manufacturer will place first three production batches on long
term stability studies throughout proposed shelf life and on accelerated
studies for 26 weeks.
Following two observations were reported in the report:
i. The HPLC software is 21CFR complaint and having certificates of
compliance by USFDA.
ii. Audit trail on the testing reports of WYMLY Tablets 25mg (Tenofovir
Alafenamide) is available.
Minutes of 294th Meeting of Registration Board | 98
iii. Adequate monitoring and control are available for stability chamber.
Chamber are controlled and monitored through software having alarm
system for alerts as well.
2.
Documents for the procurement
of API with approval from
DRAP (in case of import).
Copy of Commercial Invoice (invoice no. ZY18031601G/W) dated
attested by Assistant Director (I & E) DRAP (Karachi) dated 16-03-2018
has been submitted.
3.
Documents for the procurement
of reference standard and
impurity standards.
The firm has submitted copy of letters from M/s Neon chemicals in the
name of M/s Genix Pharma (Pvt.) Ltd, Karachi,
Particulars Batch no Quantity
Vortioxetine
hydrobromide
3804-201802001
(W/S)
3 gm
4.
Approval of API/ DML/GMP
certificate of API manufacturer
issued by regulatory authority of
country of origin.
Copy of GMP certificate (Certificate# JS 20160548) issued by Jiangsu
FDA in the name of M/s Jiangsu Yongan Pharmaceutical Co., Ltd, valid
upto 03-03-2021 has been submitted.
5.
Mechanism for Vendor pre-
qualification
The firm has submitted copy of “SOP for Selection of manufacturer for
API/Excipient and Procurement Procedure”,
SOP No: QA/SOP/SY/037 with effective date 07-10-2016.
Version no: 01
Copy of “Vendor’s Audit form” filled for M/s Jiangsu Yongan
Pharmaceutical Co. Ltd Co., Ltd, China.
6.
Certificate of analysis of the
API, reference standards and
impurity standards
Copy of COAs of Vortioxetine hydrobromide, working standards and
impurity standards issued by M/s Jiangsu Yongan Pharmaceutical Co.
Ltd .is submitted. Detail is as under
Particulars Batch no Quantity
Vortioxetine
hydrobromide
3804-201803001 300gm
Vortioxetine
hydrobromide
3804-201802001
(W/S)
3 gm
7.
Documents for the procurement
of excipients used in product
development?
The firm has submitted copy of Purchase Order/Invoices for the
procurement of excipients used in product development
8.
List of qualified staff involved
in product development with
relevant experience.
The firm has submitted copy of List of qualified staff involved in product
development & regulatory affairs comprising of 4 members.
Production Data
9.
Authorized Protocols/SOP for
the development & stability
testing of trial batches.
The firm has submitted copy of Development Protocol for Lab scale
batch manufacturing of Vortex Tablets 5mg, 10mg, 15mg and 20mg. The
SOP mentions the details of master formulation & manufacturing method
for both Vortex Tablets 5mg, 10mg, 15mg and 20mg. Copies of stability
protocols have also been submitted for Vortex Tablets 10mg.
10.
Complete batch manufacturing
record of three stability batches.
The firm has submitted copy of Batch Manufacturing Record and Batch
Packaging Record of the following 03 Batches:
BATCH NO BATCH SIZE MFG DATE
18SB-121-01 1500 Tablets 07-2018
18SB-122-02 1500 Tablets 07-2018
18SB-123-03 1500 Tablets 07-2018
Minutes of 294th Meeting of Registration Board | 99
11.
Record of remaining quantities
of stability batches.
The firm has attached Record of remaining quantities of stability batches
QA / QC DATA
12.
Record of Digital data logger
for temperature and humidity
monitoring of stability
chambers (real time &
accelerated)
The firm has submitted photocopies of digital printouts of graphical chart
for Real Time and Accelerated Conditions starting from 01-06-2018 to
31-08-2019.
13.
Method used for analysis of API
along with COA.
The firm has submitted copy of raw material specifications, raw material
testing procedures and report for Vortioxetine Hydrobromide
(batch#3804-201803001) along-with COAs for Vortioxetine
hydrobromide from M/s Jiangsu Yongan Pharmaceutical Co. Ltd., China
14.
Method used for analysis of FPP
& complete record of testing of
stability batches (i.e.
chromatograms, lab reports, raw
data sheets etc.)
The firm has submitted copy of Finished Product Testing Procedure (QC-
FPNS-143 issued on 18-07-2018) for Vortex 10mg Tablet along with
Stability Study Report of stability batches.
15.
Reports of stability studies of
API from manufacturer.
The firm has submitted copy of 06 Months Accelerated and 36 Months
Real Time Stability Study (30oC+2 oC, 65+5%) Data of 03 Batches of
Vortioxetine from M/s Jiangsu Yongan PharmaceuticalCo. Ltd., China
16.
Analysis reports for excipients
used.
The firm has submitted photocopies of its own Analytical reports for all
excipients used in product development of Vortex tablets.
17.
Drug-excipients compatibility
studies.
The firm has not performed Drug-excipients compatibility studies and
stated that the qualitative composition of their product (Vortex Tablet) is
similar to that of innovator’s product i.e. Trintellix tablet and also
stability studies have not shown any incompatibility or significant
degradation.
18.
Record of comparative
dissolution data.
Firm has submitted F2 factor protocol (QC/PRO/CD/29) & dated 18-09-
2019. The detail is as follows: feature Reference product Product of M/s Genix
Pharma
Brand name Trintellix tablet 10mg Vortex Tablets 10mg
Comparative dissolution studies have been performed in following
mediums:
i. pH 0.1N HCl buffer
ii. pH 4.5 Acetate buffer
iii. pH 6.8 Phosphate buffer
19.
Compliance Record of HPLC
software 21CFR & audit trail
reports on product testing.
Firm has submitted audit trail reports of stability studies of applied
formulation
Decision: Registration Board decided to approve registration of Vortex Tablets 10mg with
Innovator’s specifications by M/s Genix Pharma (Pvt.) Ltd. Karachi. Manufacturer will place
first three production batches on long term stability studies throughout proposed shelf life and
on accelerated studies for six months.
Minutes of 294th Meeting of Registration Board | 100
Sr.
No.
Name & Address
of Manufacturer /
Applicant
Brand Name
(Proprietary Name + Dosage
Form + Strength), Composition,
Pharmacological Group,
Finished Product Specification
Type of Form,
Initial Diary &
Date, Fee
(including
differential fee),
Demanded Price
/ Pack size
International
Availability / Local
Availability
GMP Inspection
Report Date &
Remarks
Previous
DRB
Decision /
Remarks
(if any)
87. Genix Pharma
(Pvt.) Ltd.
Karachi
Vortex Tablets 15mg
Each film coated tablet
contains:
Vortioxetine
Hydrobromide………15mg
(Innovator’s Specifications)
Form 5D
18-04-2017,
Fee: 50,000/-
As per SRO
Approved by
USFDA
Firm is operating
at acceptable
level of GMP
compliance as
per inspection
dated 10-4-2019
-
STABILITY STUDY DATA
Drug Vortex 15mg tablets
Name of Manufacturer Genix Pharma (Pvt.) Ltd.
Manufacturer of API Jiangsu Yongan Pharmaceutical
API Lot No. 3804-201803001
Description of Pack
(Container closure system) Alu-Alu Blister Pack
Stability Storage Condition Accelerated: 40°C ± 2°C / 75% ± 5%RH
Real Time: 30°C ± 2°C / 65% ± 5%RH
Time Period Accelerated: 06 months Real Time: 12 months
Frequency Accelerated: 0, 1, 2,3,4 & 6 (Months)
Real Time: 3,6, 9 , 12 (Months)
Batch No. 18SB-124-01 18SB-125-02 18SB-126-03
Batch Size 1500 Tablets 1500 Tablets 1500 Tablets
Manufacturing Date 07-2018 07-2018 07-2018
Date of Initiation 07-2020 07-2020 07-2020
No. of Batches 03
Date of Submission 12-12-2019
DOCUMENTS / DATA PROVIDED BY THE APPLICANT INITIALLY
Documents to Be Provided Status
COA of API Yes
Approval of API by regulatory authority of country
of origin or GMP certificate of API manufacturer
issued by regulatory authority of country of origin.
Yes
Protocols followed for conduction of stability study
and details of tests. Yes
Data of 03 batches will be supported by attested
respective documents like chromatograms,
laboratory reports, data sheets etc.
Yes
Documents confirming import of API etc.
Copy of Form 6 (License to Import drug for clinical
trial examination, test or analysis) issued by
Assistant Director (I & E) DRAP (Karachi) dated
16-05-2018, for the import of Vortioxetine
Minutes of 294th Meeting of Registration Board | 101
hydrobromide (300g) from the M/s Suzhou Zhiyu
Biotechnology Co, Ltd., Manufactured by
M/sJiangsu Yongan Pharmaceutical Co. Ltd.,
China has been submitted.
Copy of Commercial Invoice (invoice no.
ZY18031601G/W) dated attested by Assistant
Director (I & E) DRAP (Karachi) dated 09-04-
2018 has been submitted.
All provided documents will be attested (name, sign
and stamp) for ensuring authenticity of data /
documents.
Yes
Commitment to continue real time stability study till
assigned shelf life of the product. Yes
Commitment to follow Drug Specification Rules,
1978.
Yes
REMARKS OF EVALUATOR
(AD PEC-I)
The firm has provided 06 Months Accelerated and 12 Months Real Time Stability Data for 03 Lab Scale
Batches.
REQUEST OF EXEMPTION FROM ON SITE INSPECTION
Now the firm has requested for Exemption from On-site Investigation of their submitted stability data vide
Letter no. RA/224/19, dated 12-12-2019 and provided the following documents in conjunction with the
checklist approved by the Registration Board in its 278th Meeting:
Administrative Portion
1.
Reference of last onsite panel
inspection for instant dosage
form conducted during last two
years.
Firm has referred to onsite inspection report of their product “WYMLY
Tablets 25mg (Tenofovir Alafenamide)”, which was conducted on 06-
02-2018, and was presented in 281st meeting of Registration Board held
on 11-13th April, 2018.
Registration Board decided to approve registration of WYMLY Tablets
25mg (Tenofovir Alafenamide)”, by M/s. Genix Pharma (Pvt.) Ltd.,
Karachi. Manufacturer will place first three production batches on long
term stability studies throughout proposed shelf life and on accelerated
studies for 26 weeks.
Following two observations were reported in the report:
i. The HPLC software is 21CFR complaint and having certificates of
compliance by USFDA.
ii. Audit trail on the testing reports of WYMLY Tablets 25mg (Tenofovir
Alafenamide) is available.
iii. Adequate monitoring and control are available for stability chamber.
Chamber are controlled and monitored through software having alarm
system for alerts as well.
2.
Documents for the procurement
of API with approval from
DRAP (in case of import).
Copy of Commercial Invoice (invoice no. ZY18031601G/W) dated
attested by Assistant Director (I & E) DRAP (Karachi) dated 09-04-2018
has been submitted.
3.
Documents for the procurement
of reference standard and
impurity standards.
The firm has submitted copy of letters from M/s Neon chemicals
indenters of Pharmaceuticals Raw materials and chemicals., China, in
the name of M/s Genix Pharma (Pvt.) Ltd, Karachi,
Minutes of 294th Meeting of Registration Board | 102
Particulars Batch no Quantity
Vortioxetine
hydrobromide
3804-201802001
(W/S)
3 gm
4.
Approval of API/ DML/GMP
certificate of API manufacturer
issued by regulatory authority of
country of origin.
Approved source as per decision of 275th meeting of Registration Board
5.
Mechanism for Vendor pre-
qualification
The firm has submitted copy of “SOP for Selection of manufacturer for
API/Excipient and Procurement Procedure”,
SOP No: QA/SOP/SY/037 with effective date 07-10-2016.
Version no: 01
Copy of “Vendor’s Audit form” filled for M/sJiangsu Yongan
Pharmaceutical Co. Ltd Co., Ltd, China.
6.
Certificate of analysis of the
API, reference standards and
impurity standards
Copy of COAs of Vortioxetine hydrobromide, working standards and
impurity standards issued by M/s Jiangsu Yongan Pharmaceutical Co.
Ltd .is submitted. Detail is as under
Particulars Batch no Quantity
Vortioxetine
hydrobromide
3804-201803001 300gm
Vortioxetine
hydrobromide
3804-201802001
(W/S)
3 gm
7.
Documents for the procurement
of excipients used in product
development?
The firm has submitted copy of Purchase Order/Invoices for the
procurement of excipients used in product development
8.
List of qualified staff involved
in product development with
relevant experience.
The firm has submitted copy of List of qualified staff involved in product
development & regulatory affairs comprising of 4 members.
Production Data
9.
Authorized Protocols/SOP for
the development & stability
testing of trial batches.
The firm has submitted copy of Development Protocol for Lab scale
batch manufacturing of Vortex Tablets 5mg, 10mg, 15mg and 20mg. The
SOP mentions the details of master formulation & manufacturing method
for Vortex Tablets 10mg, 15mg and 20mg Copies of stability protocols
have also been submitted for Vortex Tablets 15mg.
The master formulation and manufacturing method mentioned in
development protocol is same as that of reference product.
10.
Complete batch manufacturing
record of three stability
batches.
The firm has submitted copy of Batch Manufacturing Record and Batch
Packaging Record of the following 03 Batches:
BATCH NO BATCH SIZE MFG DATE
18SB-124-01 1500 Tablets 07-2018
18SB-125-02 1500 Tablets 07-2018
18SB-126-03 1500 Tablets 07-2018
11.
Record of remaining quantities
of stability batches.
The firm has attached Record of remaining quantities of stability batches
QA / QC DATA
12.
Record of Digital data logger
for temperature and humidity
monitoring of stability
The firm has submitted copies of digital printouts of graphical chart for
Real Time and Accelerated Conditions starting from 01-06-2018 to 31-
08-2019.
Minutes of 294th Meeting of Registration Board | 103
chambers (real time and
accelerated)
13.
Method used for analysis of API
along with COA.
The firm has submitted ocopy of raw material specifications, raw
material testing procedures and report for Vortioxetine Hydrobromide
(batch # 3804-201803001) along with COAs for Vortioxetine
hydrobromide from M/s Jiangsu Yongan PharmaceuticalCo. Ltd., China
14.
Method used for analysis of FPP
& complete record of testing of
stability batches (i.e.
chromatograms, lab reports, raw
data sheets etc.)
The firm has submitted copy of Finished Product Testing Procedure (QC-
FPNS-144 issued on 18-07-2018) for Vortex 15mg Tablet along with
Stability Study Report of stability batches.
15.
Reports of stability studies of
API from manufacturer.
The firm has submitted copy of 06 Months Accelerated and 12 Months
Real Time Stability Study (30oC+2 oC, 65+5%) Data of 03 Batches of
Vortioxetine from M/s Jiangsu Yongan PharmaceuticalCo. Ltd., China
16.
Analysis reports for excipients
used.
The firm has submitted copies of its own Analytical reports for all
excipients used in product development of Vortex tablets.
17.
Drug-excipients compatibility
studies.
The firm has not performed Drug-excipients compatibility studies and
stated that the qualitative composition of their product (Vortex Tablet) is
similar to that of innovator’s product i.e. Trintellix
Tabletsand also stability studies have not shown any incompatibility or
significant degradation.
18.
Record of comparative
dissolution data.
Firm has submitted F2 factor protocol (QC/PRO/CD/31) & dated 23-
10-2019.
feature Reference
product
Product of M/S
Genix Pharma
Brand name Trintellix
tablet 15mg
Vortex Tablets
15mg
Comparative dissolution studies have been performed in following
mediums:
i. pH 0.1N HCl buffer
ii. pH 4.5 Acetate buffer
iii. pH 6.8 Phosphate buffer
19.
Compliance Record of HPLC
software 21CFR & audit trail
reports on product testing.
Firm has submitted audit trail reports of stability studies of applied
formulation
Decision: Registration Board decided to approve registration of Vortex Tablets 15mg with
Innovator’s specifications by M/s Genix Pharma (Pvt.) Ltd. Karachi. Manufacturer will place
first three production batches on long term stability studies throughout proposed shelf life and
on accelerated studies for six months.
Sr.
No.
Name & Address
of Manufacturer /
Applicant
Brand Name
(Proprietary Name + Dosage Form
+ Strength), Composition,
Pharmacological Group,
Finished Product Specification
Type of Form,
Initial Diary &
Date, Fee
(including
differential fee),
Demanded Price /
Pack size
International
Availability / Local
Availability
GMP Inspection
Report Date &
Remarks
Previous DRB
Decision /
Remarks
(if any)
88. Genix Pharma
(Pvt.) Ltd.
Vortex Tablets 20mg
Form 5D
26-12-2014,
Approved by
USFDA
-
Minutes of 294th Meeting of Registration Board | 104
Karachi
Each film coated tablet
contains:-
Vortioxetine
Hydrobromide………20mg
(Innovator’s Specifications)
Fee: 50,000/-
As per SRO
Firm is operating
at acceptable
level of GMP
compliance as
per inspection
dated 10-4-2019
STABILITY STUDY DATA
Drug Vortex 20mg tablets
Name of Manufacturer Genix Pharma (Pvt.) Ltd.
Manufacturer of API Jiangsu Yongan Pharmaceutical
API Lot No. 3804-201803001
Description of Pack
(Container closure system) Alu-Alu Blister Pack
Stability Storage Condition Accelerated: 40°C ± 2°C / 75% ± 5%RH
Real Time: 30°C ± 2°C / 65% ± 5%RH
Time Period Accelerated: 06 months Real Time: 12 months
Frequency Accelerated: 0, 1, 2,3,4 & 6 (Months) Real Time: 3,6, 9 , 12 (Months)
Batch No. 18SB-127-01 18SB-128-02 18SB-129-03
Batch Size 1500 Tablets 1500 Tablets 1500 Tablets
Manufacturing Date 07-2018 07-2018 07-2018
Date of Initiation 07-2020 07-2020 07-2020
No. of Batches 03
Date of Submission 08-11-2019
DOCUMENTS / DATA PROVIDED BY THE APPLICANT INITIALLY
Documents to Be Provided Status
COA of API Yes
Approval of API by regulatory authority of country
of origin or GMP certificate of API manufacturer
issued by regulatory authority of country of origin.
Yes
Protocols followed for conduction of stability study
and details of tests. Yes
Data of 03 batches will be supported by attested
respective documents like chromatograms,
laboratory reports, data sheets etc.
Yes
Documents confirming import of API etc.
Copy of Form 6 (License to Import drug for clinical
trial examination, test or analysis) issued by
Assistant Director (I & E) DRAP (Karachi) dated
16-05-2018, for the import of Vortioxetine
hydrobromide (300g) from the M/s Suzhou Zhiyu
Biotechnology Co, Ltd., Manufactured by
M/sJiangsu Yongan Pharmaceutical Co. Ltd., China
has been submitted. Copy of Commercial Invoice
(invoice no. ZY18031601G/W) dated attested by
Assistant Director (I & E) DRAP (Karachi) dated
16-03-2018 has been submitted.
All provided documents will be attested (name, sign
and stamp) for ensuring authenticity of data /
documents.
Yes
Minutes of 294th Meeting of Registration Board | 105
Commitment to continue real time stability study till
assigned shelf life of the product. Yes
Commitment to follow Drug Specification Rules,
1978. Yes
REMARKS OF EVALUATOR (AD PEC-I)
The firm has provided 06 Months Accelerated and 12 Months Real Time Stability Data for 03 Lab Scale
Batches.
REQUEST OF EXEMPTION FROM ON SITE INSPECTION
Now the firm has requested for Exemption from On-site Investigation of their submitted stability data vide
Letter no. RA/204/19, dated 11-11-2019 and provided the following documents in conjunction with the
checklist approved by the Registration Board in its 278th Meeting:
Administrative Portion
1.
Reference of last onsite panel
inspection for instant dosage
form conducted during last two
years.
Firm has referred to onsite inspection report of their product “WYMLY
Tablets 25mg (Tenofovir Alafenamide)”, which was conducted on 06-
02-2018, and was presented in 281st meeting of Registration Board held
on 11-13th April, 2018.
Registration Board decided to approve registration of WYMLY Tablets
25mg (Tenofovir Alafenamide)”, by M/s. Genix Pharma (Pvt.) Ltd.,
Karachi. Manufacturer will place first three production batches on long
term stability studies throughout proposed shelf life and on accelerated
studies for 26 weeks.
Following two observations were reported in the report:
i. The HPLC software is 21CFR complaint and having certificates of
compliance by USFDA.
ii. Audit trail on the testing reports of WYMLY Tablets 25mg (Tenofovir
Alafenamide) is available.
iii. Adequate monitoring and control are available for stability chamber.
Chamber are controlled and monitored through software having alarm
system for alerts as well.
2.
Documents for the procurement
of API with approval from
DRAP (in case of import).
Copy of Commercial Invoice (invoice no. ZY18031601G/W) dated
attested by Assistant Director (I & E) DRAP (Karachi) dated 16-03-2018
has been submitted.
3.
Documents for the procurement
of reference standard and
impurity standards.
The firm has submitted copy of letters from M/s Neon Chemicals
indentors of Pharmaceutical Raw material and chemicals, in the name of
M/s Genix Pharma (Pvt.) Ltd, Karachi,
Particulars Batch no Quantity
Vortioxetine
hydrobromide
3804-201802001
(W/S)
3gm
4.
Approval of API/ DML/GMP
certificate of API manufacturer
issued by regulatory authority of
country of origin.
Copy of GMP certificate (Certificate# JS 20160548) issued by Jiangsu
FDA in the name of M/s Jiangsu Yongan Pharmaceutical Co., Ltd, valid
upto 03-03-2021 has been submitted.
5.
Mechanism for Vendor pre-
qualification
The firm has submitted copy of “SOP for Selection of manufacturer for
API/Excipient and Procurement Procedure”,
SOP No: QA/SOP/SY/037 with effective date 07-10-2016.
Version no: 01
Copy of “Vendor’s Audit form” filled for M/sJiangsu Yongan
Pharmaceutical Co. Ltd Co., Ltd, China.
Minutes of 294th Meeting of Registration Board | 106
6.
Certificate of analysis of the
API, reference standards and
impurity standards
Copy of COAs of Vortioxetine hydrobromide, working standards and
impurity standards issued by M/s Jiangsu Yongan Pharmaceutical Co.
Ltd .is submitted. Detail is as under
Particulars Batch no Quantity
Vortioxetine
hydrobromide
3804-201803001 300 gm
Vortioxetine
hydrobromide
3804-201802001
(W/S)
3gm
7.
Documents for the procurement
of excipients used in product
development?
The firm has submitted copy of Purchase Order/Invoices for the
procurement of excipients used in product development
8.
List of qualified staff involved
in product development with
relevant experience.
The firm has submitted copy of List of qualified staff involved in product
development & regulatory affairs comprising of 4 members.
Production Data
9.
Authorized Protocols/SOP for
the development & stability
testing of trial batches.
The firm has submitted copy of Development Protocol for Lab scale
batch manufacturing of Vortex Tablets 5mg, 10mg, 15mg and 20mg. The
SOP mentions the details of master formulation & manufacturing method
for both Vortex Tablets 5mg, 10mg, 15mg and 20mg. Copies of stability
protocols have also been submitted for Vortex Tablets 20mg.
10.
Complete batch manufacturing
record of three stability batches.
The firm has submitted copy of Batch Manufacturing Record and Batch
Packaging Record of the following 03 Batches:
BATCH NO BATCH SIZE MFG DATE
18SB-127-01 1500 Tablets 07-2018
18SB-128-02 1500 Tablets 07-2018
18SB-129-03 1500 Tablets 07-2018
As per submitted record all the activities of manufacturing i.e.
dispensing, granulation, drying, compression & coating has been
performed in PD lab.
11.
Record of remaining quantities
of stability batches.
The firm has attached Record of remaining quantities of stability batches
QA / QC DATA
12.
Record of Digital data logger for
temperature and humidity
monitoring of stability chambers
(real time & accelerated)
The firm has submitted photocopies of digital printouts of graphical chart
for Real Time and Accelerated Conditions starting from 01-06-2018 to
03-04-2019.
13.
Method used for analysis of API
along with COA.
The firm has submitted copy of raw material specifications, raw material
testing procedures and report for Vortioxetine Hydrobromide (batch #
3804-201803001) along with COAs for Vortioxetine hydrobromide from
M/s Jiangsu Yongan Pharmaceutical Co. Ltd., China
14.
Method used for analysis of FPP
& complete record of testing of
stability batches (i.e.
chromatograms, lab reports, raw
data sheets etc.)
The firm has submitted copy of Finished Product Testing Procedure (QC-
FPNS-145 issued on 18-07-2018) for Vortex 20mg Tablet along with
Stability Study Report of stability batches.
15.
Reports of stability studies of
API from manufacturer.
The firm has submitted copy of 06 Months Accelerated and 36 Months
Real Time Stability Study (30oC+2 oC, 65+5%) Data of 03 Batches of
Vortioxetine from M/s Jiangsu Yongan PharmaceuticalCo. Ltd., China
Minutes of 294th Meeting of Registration Board | 107
16.
Analysis reports for excipients
used.
The firm has submitted photocopies of its own Analytical reports for all
excipients used in product development of Vortex tablets.
17.
Drug-excipients compatibility
studies.
The firm has not performed Drug-excipients compatibility studies and
stated that the qualitative composition of their product (Vortex Tablet) is
similar to that of innovator’s product i.e. Trintellix tablet and also
stability studies have not shown any incompatibility or significant
degradation.
18.
Record of comparative
dissolution data.
Firm has submitted F2 factor protocol (QC/PRO/CD/30) & dated 25-
09-2019. The detail is as follows: feature Reference product Product of M/S Genix
Pharma
Brand name Trintellix tablet 20mg Vortex Tablets 20mg
Comparative dissolution studies have been performed in following
mediums:
i. pH 0.1N HCl buffer
ii. pH 4.5 Acetate buffer
iii. pH 6.8 Phosphate buffer
19.
Compliance Record of HPLC
software 21CFR & audit trail
reports on product testing.
Firm has submitted audit trail reports of stability studies of applied
formulation
Decision: Registration Board decided to approve registration of Vortex Tablets 20mg with
Innovator’s specifications by M/s Genix Pharma (Pvt.) Ltd. Karachi. Manufacturer will place
first three production batches on long term stability studies throughout proposed shelf life and
on accelerated studies for six months.
Item No. 4: Agenda of Evaluator PEC-III
Case No. 01 Registration applications of CTD cases
a. New cases
89. Name, address of Applicant / Marketing
Authorization Holder
M/s Bio-Labs (Pvt) Ltd. Plot No. 145, Industrial Triangle
Kahuta Road Islamabad.
Name, address of Manufacturing site. M/s Bio-Labs (Pvt) Ltd. Plot No. 145, Industrial Triangle
Kahuta Road Islamabad.
Status of the applicant ☒ Manufacturer
☐ Importer
☐ Is involved in none of the above (contract giver)
Status of application ☐ New Drug Product (NDP)
☒ Generic Drug Product (GDP)
Intended use of pharmaceutical product ☒ Domestic sale
☐ Export sale
☐ Domestic and Export sales
Dy. No. and date of submission Dy. No. 8159: 12-06-2019
Details of fee submitted PKR 20,000/-: 11-06-2019
The proposed proprietary name / brand
name BioChlor Gel 7.1%
Strength / concentration of drug of Active
Pharmaceutical ingredient (API) per unit
Each gram gel contains
Chlorhexidine gluconate………7.1%w/w
Minutes of 294th Meeting of Registration Board | 108
Pharmaceutical form of applied drug Almost light yellow color viscous gel
Pharmacotherapeutic Group of (API) Antiseptics and disinfectants, biguanides and amidines
Reference to Finished product
specifications
BP
Proposed Pack size 20gm gel
Proposed unit price As per SRO
The status in reference regulatory
authorities
Umbipro 7.1% w/w Gel by GSK EMA No.
EMEA/H/W/003799/001
For generic drugs (me-too status) Cordin gel by Global Pharma (Reg# 096587)
Name and address of API manufacturer. Unilab chemical and pharmaceuticals Pvt Ltd. W-32, MIDC
Phase-II Dombivli East MH 421 204 India.
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-PD template.
Module-III Drug Substance: Firm has submitted complete data of drug substance from the
API manufacturer.
Stability Studies of Drug Substance
(Conditions & duration of Stability
studies)
Firm has submitted stability study data sheets of API as per
zone IV-A for 36 months.
Module-III Drug Product: Firm has submitted all the drug product data required for
module 3
Pharmaceutical Equivalence and
Comparative Dissolution Profile
Firm has submitted pharmaceutical equivalence data in
comparison with the innovator product Umbipro 7.1% w/w Gel.
Analytical method validation/verification
of product
Firm has submitted analytical method validation data.
STABILITY STUDY DATA
Manufacturer of API Unilab chemical and pharmaceuticals Pvt Ltd. W-32, MIDC Phase-II Dombivli
East MH 421 204 India.
API Lot No. F/151/18
Description of Pack
(Container closure system) 20 gram tube
Stability Storage Condition Real time : 30°C ± 2°C / 65% ± 5%RH
Accelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real time: 6 months Accelerated: 6 months
Frequency Accelerated: 0, 1, 2, 3, 4, 6 (Months) Real Time: 0, 3, 6 (Months)
Batch No. CXG-001 CXG-002 CXG-003
Batch Size 80 tubes 80 tubes 80 tubes
Manufacturing Date 10-2018 10-2018 10-2018
Date of Initiation 05-10-2018 06-10-2018 06-10-2018
No. of Batches 03
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Documents To Be Provided Status
COA of API Yes
Approval of API by regulatory authority of
country of origin or GMP certificate of API
manufacturer issued by regulatory authority of
Firm has submitted copy of GMP certificate issued by FDA
Mahrashtra dated 28-12-2017 valid till December 2020.
Minutes of 294th Meeting of Registration Board | 109
country of origin.
Protocols followed for conduction of stability
study and details of tests. Yes
Data of 03 batches will be supported by attested
respective documents like chromatograms,
laboratory reports, data sheets etc.
Yes
Documents confirming import of API etc. Firm has submitted copy of invoice cleared by DRAP
Islamabad office dated 04-09-2018 specifying import of 2kg
chlorhexidine gluconate 20% solution
All provided documents will be attested (name,
sign and stamp) for ensuring authenticity of data
/ documents.
Yes
Commitment to continue real time stability study
till assigned shelf life of the product. Yes
Commitment to follow Drug Specification
Rules, 1978. Yes
REMARKS OF EVALUATOR
Firm has provided evidence of Cream (General) section.
How the homogeneity in the gel texture is ensured without the use of high-pressure homogenizer.
The use of guar gum having pH 5.5 to 7.5 (acidic pH) can potentially cause degradation of chlorhexidine.
How the firm will control this process of degradation.
Report on investigation of authenticity / genuineness of data submitted for registration of BioChlor Gel
7.1% by M/s Bio-labs (Pvt) Ltd. Plot No. 145, Industrial Triangle Kahuta Road, Islamabad.
Reference No: No. F.1-2/2020-PEC dated 18th February, 2020.
Investigation Date & Time: 11th March, 2020
Investigation Site: Factory premises of M/s Bio-labs (Pvt) Ltd. Plot No. 145, Industrial Triangle Kahuta Road,
Islamabad.
Background: Chairman Registration Board has constituted the panel of M/s Bio-labs (Pvt) Ltd. Plot No. 145, Industrial
Triangle Kahuta Road, Islamabad for BioChlor Gel 7.1% for on-site investigation to confirm the authenticity /
genuineness of stability data and associated documents, import of API, quality, specification, test analysis and
facilities etc for further consideration by the Registration Board.
Composition of Panel:
1. Dr. Qurban Ali, Member Registration Board
2. Mst. Tehreem Sara, Deputy Director (RRR) PE&R Division DRAP, Islamabad
3. Mr. Muhammad Haseeb Tariq, Assistant Director PEC, PE&R Division DRAP, Islamabad.
Scope of Investigation:
Investigation of the authenticity / genuineness of the data, manufacturing of stability batches and stability studies
on these batches.
Tool for investigation:
The investigation was conducted by using a structured questionnaire of DRAP. For objective evidence physical
inspection of the facilities for manufacturing and quality control, material used and retained, personnel involved,
ongoing studies, printed data and integrity and security of data in respective databases were also audited. The
details of investigation may be summarized as under:
Minutes of 294th Meeting of Registration Board | 110
Detail of investigation for BioChlor Gel 7.1%
Sr.
No.
Description Observation by panel
1. Do you have documents confirming the
import of API including approval from
DRAP?
Firm has all necessary documents including invoice /AD
clearance dated 04-09-2018 confirming import of 2 kg
Chlorhexidine gluconate 20% solution from M/s Unilab
Chemicals & Pharma Pvt. Ltd. India.
2. Do you have any rationale behind selecting
the particular manufacturer
Firm has a developed SOP for vendor qualification
including Vendor Evaluation Form and they have
selected this vendor based on its GMP certificate, DMF
as well as stability study data.
3. Do you have documents confirming the
Import of Reference standard and Impurities
standards?
Working standard of Chlorhexidine gluconate was
provided by the supplier and the firm has imported
reference standard and impurity standard from USP.
4. Do you have certificate of analysis of API
reference standard & impurities standards?
Firm has certificate of analysis of API, working standard
as well as impurity standards.
5. Do you have any approval of API or GMP
certificate of manufacturer issued by
regulatory authority of country of origin?
Firm has copy of GMP certificate of M/s Unilab
Chemicals & Pharma Pvt. Ltd. India issued by Food and
Drug Administration Mahrashtra state dated 28-12-2017.
6. Do you use API manufacturer method of
Testing for testing of API?
The firm has used BP method of testing for carrying out
tests of API.
7. Do you have stability Studies Report on
API?
The firm has real time and accelerated stability study data
sheets provided by the API manufacturer. The real time
stability study data as per zone IV-A till 36 months was
provided by the API manufacturer.
8. If Yes, whether the stability testing has been
performed as per SIM method and
degradation products have been quantified?
The stability studies have been performed as per SIM
method and the API manufacturers have quantified the
degradation products.
9. Do you have method for quantifying the
impurities in the API?
The firm has used BP method for quantifying the
impurities in the API.
10. Do you have some remaining quantities of
the API, Its reference standard and
impurities standard?
Firm has some remaining quantity of API and working
standards.
11. Have you used pharmaceutical grade
excipients?
Firm has used pharmaceutical grade excipients in the
manufacturing of stability batches.
12. Do you have documents confirming the
import of the used excipients?
Firm has necessary documents confirming import /
purchase of used excipients.
13. Do you have test reports and other records
on the excipients?
The firm has test reports and certificate of analysis for all
excipients used in the manufacturing of stability batches.
14. Do you have written and authorized
protocols for development drug product?
The firm has written and authorized protocols for the
development of BioChlor Gel 7.1%.
15. Have you performed Drug-Excipient
compatibility studies?
Firm has demonstrated that their formulation is
qualitatively similar to the innovator product (Umbipro
Gel by GSK), therefore they have not performed drug-
excipient compatibility studies.
16. Have you performed comparative
dissolution studies?
Not applicable since this product is Gel. However, the
firm has performed pharmaceutical equivalence studies
with the innovator product as per requirement of CTD.
Minutes of 294th Meeting of Registration Board | 111
17. Do you have Product Development / R&D
Section?
Firm has seprate area / room for product development
with small scale equipment.
18. Do you have necessary equipment’s
available in product development section
for development drug product?
Firm has necessary equipment available in product
development section for development of trial batches.
19. Are the equipment’s in product
development qualified?
The equipment present in product development area were
qualified.
20. Do you have proper maintenance /
calibration / re-qualification program for the
equipment used in PD?
The firm has proper maintenance and calibration for the
equipment used in product development section.
21. Do you have qualified staff in product
development section with proper knowledge
& training in product development?
Firm has trained & qualified staff in product development
section with proper knowledge and training in product
development and testing.
22. Have you manufactured three stability
batches for the stability studies of drug
product?
Three stability batches have been manufactured for the
stability studies of BioChlor Gel 7.1% with batch
numbers CXG-001, CXG-002 and CXG-003.
23. Do you have any criteria for fixing the batch
size of stability of batches?
The firm has informed that their criteria for fixing batch
size is based on number of tests required, testing
frequencies and number of units used in each test.
24. Do you have complete record of production
of stability batches?
The firm has complete batch manufacturing record of all
the batches of BioChlor Gel 7.1%
25. Do you have protocols for stability testing
of stability batches?
Firm has written protocols for stability testing of the
stability batches.
26. Do you have developed and validated the
method for testing of stability batches?
The firm has developed and validated HPLC method for
testing of the stability batches.
27. Do you have method transfer studies in case
when the method of testing being used by
your firm is by any other lab?
NA
28. Do you have documents confirming the
qualification of equipment / instruments
being used in the test and analysis of the
product’s API and drug product?
Firm has complete record of qualification of equipment /
instruments used in the test and analysis of API and
BioChlor Gel 7.1%.
29. Do your method of analysis Stability
indicating?
The firm has used BP method for testing of the finished
product; however the firm was advised to quantify the
degradation products for commercial batches.
30. Is your HPLC software 21CFR compliant? The firm has a dedicated HPLC (Schimadzu LC-20
Gradient) for testing of new drug products placed on
stability studies. The HPLC software for that particular
HPLC is 21 CFR compliant with audit trail option
activated. However the firm has only 1 login account in
the software which is used by various analysts on the
same system. The firm was advised to get separate
account for each analyst.
31. Can you show audit trail reports on drug
product testing?
Audit trail reports for testing of BioChlor Gel 7.1% were
available.
32. Do you have some remaining quantities of
degradation products and stability batches?
The firm has remaining quantities of stability batches
which are kept in stability chamber for ongoing real time
stability study.
33. Do you have batches kept on stability
testing?
The firm has kept the remaining quantities of all batches in
stability chamber for on-going real time stability study.
Minutes of 294th Meeting of Registration Board | 112
34. Do you have valid calibration status for the
equipment’s used in drug product’s
production and analysis?
The firm has valid calibration status of all equipment used
in production and analysis of BioChlor Gel 7.1%.
35. Do Proper and Continuous monitoring and
control are available for stability chamber?
The firm has stability chambers for carrying out accelerated
and real time stability studies provided with uninterrupted
power supply and USB data loggers, which are set for
recording temperature and humidity after every hour.
36. Do related manufacturing area, equipment,
personnel and utilities be rated as GMP
compliant?
Firm has dedicated area for product development. Related
manufacturing area, equipment, personnel and utilities
were cGMP compliant to satisfactory level.
However, firm has got approval of only Cream (General)
section from Licensing Division, DRAP. The firm has
steam jacketed mixer (400kg) which can operate from 20
to 3000 rpm. The firm is using the same manufacturing /
filling line for cream, ointment as well as gel.
37. How the homogeneity in the gel texture is
ensured without the use of high-pressure
homogenizer
The firm has steam jacketed mixer (400kg) installed in
Cream (General) Section area which can operate from 20
to 3000 rpm. The firm intends to use the same production /
filling line for cream, ointment as well as gel products. The
firm has following documents / studies to justify the
manufacturing and filling of gel in the same section.
Performance qualification protocols and reports for steam
jacketed mixer (400kg) installed in cream (general) section.
The report specifies less than 3% deviation in rpm when
used as high speed homogenizer (3000rpm).
Prospective/concurrent validation report of 3 batches of
their already registered product “Proxicam Gel 25 gm”
wherein the reports suggest acceptable results for assay,
physical appearance and weight variation.
38. The use of guar gum having pH 5.5 to 7.5
(acidic pH) can potentially cause
degradation of chlorhexidine. How the firm
will control this process of degradation.
The firm has used guar gum as a gelling agent in their
formulation. The same ingredient is also used by the
innovator product “Umbipro Gel”. Sodium acetate
trihydrate is used to maintain the pH of gel within the
range of 5.0 to 7.0. The innovator product has also used
the same ingredient to control the pH. The control of pH
has been demonstrated through the results till 12 months
stability studies. The firm also demonstrated the pH of the
gel in front of panel. The results of the pH tested in front
of the panel was 6.6 which is within the acceptable range
of BP monograph.
Conclusion:
On the basis of risk-based approach the genuineness / authenticity of stability data submitted by the firm
for registration of BioChlor Gel 7.1% is verifiable to satisfactory level.
Related manufacturing area, equipment, personnel & Utilities are rated as GMP Compliant to
satisfactory level. However, the firm do not have approval of Gel section from Licensing Division, DRAP. The
firm has demonstrated that the manufacturing / filling line available in Cream (General) section is capable of
working as high speed homogenizer for the manufacturing and filling of applied product.
Decision: Registration Board decided to approve registration of BioChlor Gel 7.1% by M/s Bio-
labs (Pvt) Ltd. Plot No. 145, Industrial Triangle Kahuta Road, Islamabad. Manufacturer will
place first three production batches on long term stability studies throughout proposed shelf life
and on accelerated studies for six months. Manufacturer will also perform process validation
studies on first three commercial batches as per the commitment submitted along with
registration application.
Minutes of 294th Meeting of Registration Board | 113
90. Name, address of Applicant / Marketing
Authorization Holder
M/s Highnoon Laboratories Ltd., 17.5KM.,Multan Road,
Lahore
Name, address of Manufacturing site. M/s Highnoon Laboratories Ltd, 17.5KM, Multan Road,
Lahore
Status of the applicant ☒ Manufacturer
☐ Importer
☐ Is involved in none of the above (contract giver)
GMP status of the firm Firm has submitted copy of GMP certificate issued on the basis
of inspection conducted dated 08-11-2018.
Evidence of approval of manufacturing
facility
Firm has submitted copy of GMP certificate dated 15-11-2018
specifying Tablet General non antibiotic section
Status of application ☐ New Drug Product (NDP)
☒ Generic Drug Product (GDP)
Intended use of pharmaceutical product ☐ Domestic sale
☐ Export sale
☒ Domestic and Export sales
Dy. No. and date of submission Dy. No. 21124: 18-10-2019
Details of fee submitted PKR 20,000/-: 18-10-2019
The proposed proprietary name / brand
name
Biforge 5mg/80mg Tablet
Strength / concentration of drug of Active
Pharmaceutical ingredient (API) per unit
Each film coated tablet contains:
Amlodipine………….5mg
Valsartan……………80mg
Pharmaceutical form of applied drug Blue round biconvex film coated tablet with bisect line on one
side
Pharmacotherapeutic Group of (API) Anti hypertensive
Reference to Finished product
specifications
USP
Proposed Pack size 14’s, 28’s
Proposed unit price As per SRO
The status in reference regulatory
authorities
Exforge 5mg/80mg film coated tablets (USFDA Approved)
For generic drugs (me-too status) Exforge tablets by Novartis
Name and address of API manufacturer. Amlodpine: Cadila Pharmaceuticals Limited. 294, GIDC,
Industrial Estate Ankleshwar 393 002, Gujrat India.
Valsartan: Zheijiang Tianyu Pharmaceuticals
No.15 Donghai 5th Avenue, Zhejiang.
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-PD template.
Module-III Drug Substance: Firm has submitted drug substance data for both API separately
as per the CTD module 3.2.S.
Stability Studies of Drug Substance
(Conditions & duration of Stability
studies)
Amlodipine: Firm has submitted stability study data of 3
batches of API at accelerated and real time conditions. The real
time stability data is conducted as per zone IV-A conditions.
Valsartan: Firm has submitted stability study data of 3 batches
of API at accelerated and real time conditions. The real time
stability data is conducted as per zone IV-A conditions.
Minutes of 294th Meeting of Registration Board | 114
Module-III Drug Product: Firm has submitted data of drug product as per the requirements
of Module 3.2.P
Pharmaceutical Equivalence and
Comparative Dissolution Profile
Firm has submitted detailed process and results for formulation
development, the firm has developed 4 trials of the applied
formulation and based on the results trial 4 was finally selected.
Firm has performed pharmaceutical equivalence studies and
comparative dissolution studies with the reference product and
the selection of final trial batch was based on the results of these
trials. The results of pharmaceutical equivalence and CDP were
satisfactory justifying the formulation development.
Analytical method validation/verification
of product
Firm has submitted reports of verification studies of analytical
method, since this finished product specifications are available
in USP.
STABILITY STUDY DATA
Manufacturer of API Amlodpine: Cadila Pharmaceuticals Limited. 294, GIDC, Industrial Estate
Ankleshwar 393 002, Gujrat India.
Valsartan: Zheijiang Tianyu Pharmaceuticals No.15 Donghai 5th Avenue,
Zhejiang.
API Lot No. Amlodpine: 17ADM1060
Valsartan: 10230-161205
Description of Pack
(Container closure system) Alu-Alu Blister
Stability Storage Condition Real time : 30°C ± 2°C / 65% ± 5%RH
Accelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real time: 6 months Accelerated: 6 months
Frequency Accelerated: 0, 3, 6 (Months) Real Time: 0, 3, 6, 9, 12, 18 (Months)
Batch No. RD-18056 RD-18057 RD-18058
Batch Size 10,000 tablet 10,000 tablet 10,000 tablet
Manufacturing Date 02-2018 02-2018 02-2018
Date of Initiation 03-2018 03-2018 03-2018
No. of Batches 03
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
# Documents To Be Provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of
country of origin or GMP certificate of API
manufacturer issued by regulatory authority
of country of origin.
Amlodipine: Firm has submitted copy of European CEP
certificate for the same manufacturing site.
Valsartan: The firm has submitted copy of GMP Certificate
(Certificate#ZJ20160065) for M/s Zhejiang Tianyu
pharmaceutical Co. Ltd., China issued by China Food and
Drug Administration, China. It is valid till 05-12-2021.
3. Protocols followed for conduction of stability
study and details of tests. Yes
4. Data of 03 batches will be supported by
attested respective documents like
chromatograms, laboratory reports, data
sheets etc.
Yes
5. Documents confirming import of API etc. Amlodipine: Firm has submitted copy of invoice specifying
Minutes of 294th Meeting of Registration Board | 115
import of 100Kg amlodipine. The invoice is signed by AD
DRAP Lahore, dated 23-05-2017
Valsartan: Firm has submitted copy of invoice specifying
import of 500Kg Valsartan. The invoice is signed by AD
DRAP Lahore, dated 21-06-2017
6. All provided documents will be attested
(name, sign and stamp) for ensuring
authenticity of data / documents.
Yes
7. Commitment to continue real time stability
study till assigned shelf life of the product. Yes
8. Commitment to follow Drug Specification
Rules, 1978. Yes
REMARKS OF EVALUATOR
Decision: Registration Board decided to approve registration of Biforge 5mg/80mg Tablet by
M/s Highnoon Laboratories Limited 17.5 KM. Multan Road, Lahore. Manufacturer will place
first three production batches on long term stability studies throughout proposed shelf life and
on accelerated studies for six months. Manufacturer will also perform process validation studies
on first three commercial batches as per the commitment submitted along with registration
application.
Minutes of 294th Meeting of Registration Board | 116
Case No. 02 Registration applications of drugs for which stability study data is submitted
a. New cases
Sr.
No.
Name & Address of
Manufacturer /
Applicant
Brand Name
(Proprietary Name + Dosage
Form + Strength), Composition,
Pharmacological Group,
Finished Product Specification
Type of Form,
Initial Diary & Date,
Fee (including
differential fee),
Demanded Price /
Pack size
International Availability / Local
Availability
GMP Inspection Report Date &
Remarks
91. M/s Genix Pharma
(Pvt) Ltd., 44, 45-B,
Korangi Creek
Road, Karachi
Movcol Paediatric Sachet
Each sachet contains:
Macrogol 3350……6.563g
Sodium chloride….0.1754g
Sodium bicarbonate
…………0.0893g
Potassium chloride..0.0233g
Form 5-D
Dy No. 26683
29-12-2017
PKR 50,000/-
(28-12-2017)
MOVICOL-Half 6.9g sachet,
powder for oral solution (MHRA
Approved)
Last GMP inspection conducted
on 16-02-2018
Specifies satisfactory level of
cGMP compliance.
Remarks of Evaluator:
The firm has initially applied for the formulation, which have different strength of potassium chloride, later
dated 30-8-2019 the firm has submitted revised form 5D along with 50,000/- fee and correct composition as
per reference product.
Now the firm has submitted stability study data along with required documents as per checklist approved in
251st meeting of Registration Board. Detailsof submitted data are as under:
(Dy.# 16898 dated 05-9-2019)
STABILITY STUDY DATA
Drug Movcol Paediatric Sachet
Name of Manufacturer M/s Genix Pharma (Pvt) Ltd., 44,45-B, Korangi Creek Road, Karachi
Manufacturer of API Polyethylene glycol 3350: Avesta Pharma (Pvt) Ltd. Mahrashtra State India
Sodium chloride: Dominion Salt Limited, New Zealand
Sodium bicarbonate: Hangzhou Zhongbao Corp Ltd Hanghzou China.
Potassium chloride: K+S KALI GmbH, Germany
API Lot No. Polyethylene glycol 3350: AP0918048
Sodium chloride: 24042018
Sodium bicarbonate: 20180822
Potassium chloride: 2015056
Description of Pack
(Container closure system) Printed aluminium foil
Stability Storage Condition Real time : 30°C ± 2°C / 65% ± 5%RH
Accelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real time: 6 months Accelerated: 6 months
Frequency Accelerated: 0, 1, 2, 3, 4, 6 (Months) Real Time: 0, 3, 6 (Months)
Batch No. 18SB-185-01 18SB-186-02 18SB-187-03
Batch Size 1500 Sachet 1500 Sachet 1500 Sachet
Manufacturing Date 10-2018 10-2018 10-2018
Date of Initiation 29-10-2018 29-10-2018 29-10-2018
No. of Batches 03
Date of Submission Dy.# 16898 dated 05-9-2019
Minutes of 294th Meeting of Registration Board | 117
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
# Documents To Be Provided Status
a) COA of API Yes
b) Approval of API by regulatory authority
of country of origin or GMP certificate of
API manufacturer issued by regulatory
authority of country of origin.
Polyethylene Glycol: Firm has submitted copy of GMP certificate
of Avesta Pharma (Pvt) Ltd issued by FDA Mahrashtra dated 09-
05-2019.
Sodium chloride: Firm has submitted copy of GMP certificate of
Dominion Salt Limited, New Zealand issued by Medsafe,
NewZealand Medicine and Medical Device Safety Authority
which is valid till 09-02-2020.
Sodium bicarbonate:
Potassium chloride: Firm has submitted copy of GMP certificate
of K+S KALI GmbH, Germany issued by Regierungsprasidium
Darmstadt Pharmazie Luisenplatz 2 Darmstadt Deutschland dated
12 April 2018.
c) Protocols followed for conduction of
stability study and details of tests. Yes
d) Data of 03 batches will be supported by
attested respective documents like
chromatograms, laboratory reports, data
sheets etc.
Yes
e) Documents confirming import of API etc. Polyethylene Glycol: Firm has submitted copy of commercial
invoice specifying import of 9275 Kg Polyethylene Glycol 3350
USP from Avesta Pharma Pvt. Ltd. India. The invoice was cleared
by DRAP Karachi office on 24-9-2018.
Sodium chloride: Firm has submitted copy of invoice of Mak
Kemikal dated 06-09-2018 specifying purchase of 400Kg sodium
chloride. The invoice does not specify the details regarding
manufacturer, batch number and expiry / re test date of API.
Sodium bicarbonate: Firm has submitted copy of invoice of U.T
corporation dated 08-10-2018 specifying purchase of 500Kg
potassium chloride. The invoice does not specify the details
regarding manufacturer, batch number and expiry / re test date of
API.
Potassium chloride: Firm has submitted copy of invoice of U.T
corporation dated 05-09-2018 specifying purchase of 49.4Kg
potassium chloride. The invoice does not specify the details
regarding manufacturer, batch number and expiry / re test date of
API.
f) All provided documents will be attested
(name, sign and stamp) for ensuring
authenticity of data / documents.
Yes
g) Commitment to continue real time
stability study till assigned shelf life of the
product.
Yes
h) Commitment to follow Drug Specification
Rules, 1978. Yes
REMARKS OF EVALUATOR
Shortcomings communicated Response by the firm
Minutes of 294th Meeting of Registration Board | 118
Submit clear copy of Assistant Director (I & E) DRAP
attested commercial invoice for import of polyethylene
glycol 3350, since the submitted invoice is not properly
readable.
Firm has submitted clear invoice.
Submit evidence of procurement of all drug substances
from licensed pharmaceutical manufacturer’s having
valid GMP certificates, since the submitted evidence of
proof do not specify the manufacturer as well as details
pertaining to the specific batch like batch number and
expiry / re-test date.
Firm has submitted that the material was locally
purchased and was analysed according to
pharmacopoeia. CoA are attached.
Submit valid and clear copies of GMP certificate of drug
substance manufacturer’s from which the drug
substance was procured.
Firm has submitted GMP certificate of
manufacturers of all APIs.
Justify the identification test of Macrogol 3350 through
assay by UV in the finished product specification, since
the drug substance manufacturer specifies IR testing for
identification of macrogol 3350.
The standard absorbance corresponds to sample
preparation at 440nm as performed in assay.
In Raw material testing PEG is identified by FTIR,
while in finished product there is mixture of multiple
APIs and excipients so we selected UV method by
absorbance at wavelength of standard and sample
preparation.
Justify the identification of sodium bicarbonate and
sodium chloride through assay which are being tested
using titration method.
Both titration points are different. In sodium
bicarbonate faint pink colour is the end point which
is titrated by 0.1N HCl.
Sodium chloride is titrated by 0.1N silver nitrate and
develop pink color precipitate in the form of silver
chloride at end point.
Justify the development of raw material testing methods
in January 2019 while the stability studies were initiated
in October 2018.
The submitted testing method is version 3. This
testing method is revised due to format change in Jan
2019 as mentioned in revision history but the method
is same.
Justify why the moisture content is not determined in the
drug product.
Our manufacturing process is dry mixing. No wet
granulation procedure is adapted and no material is
hygroscopic that’s why it is not applicable for
moisture content.
Justify why the dissolution test is not performed on the
drug product.
The electrolytes and PEG 3350 is highly water
soluble that’s why dissolution test is skipped.
ICH guidelines Stability testing of new drug substances
and products Q1A(R2), recommends “Stability testing
of the drug product after constitution or dilution, if
applicable, should be conducted to provide information
for the labeling on the preparation, storage condition,
and in-use period of the constituted or diluted product.
This testing should be performed on the constituted or
diluted product through the proposed in-use period on
primary batches as part of the formal stability studies at
initial and final time points.” Justify why the in-use
stability testing is not performed and what are the
recommendations for reconstitution of the sachet and
what are the recommended storage conditions and
maximum time till which the reconstituted solution can
be used.
As it is directed in the label it should be freshly
prepared and used that’s why it is not applicable.
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Movcol
Paediatric Sachet (Macrogol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride) by M/s
Genix Pharma Pvt. Limited, Karachi.
Minutes of 294th Meeting of Registration Board | 119
Reference No: F.1-2/2020-PEC dated 1st January, 2020.
Investigation Date and Time: 7th February, 2020. (Forenoon)
Investigation Site: Factory premises of Genix Pharma Pvt. Ltd. Karachi.
Background:
Chairman Registration Board considered the applications of M/s. Genix Pharma (Pvt.) Ltd., Karachi for
registration of Movcol Paediatric Sachet (Macrogol 3350, Sodium Chloride, Sodium Bicarbonate, and Potassium
Chloride) and constituted a three member panel to investigate the authenticity / genuineness of data (import of raw
material and stability data). Panel was advised to conduct inspection of the firm and to submit report for further
consideration. The panel was also advised to verify:
“Procurement of APIs before manufacturing of stability batches”
Composition of Panel:
1. Dr. Rafeeq Alam Khan, Meritorious Professor and Dean Faculty of Pharmacy, Ziauddin University,
Karachi.
2. Dr. Kirshan, Assistant Director, DRAP, Karachi.
3. Dr. Affan Ali Qureshi, Assistant Director, CDL, DRAP, Karachi.
Scope of investigation:
Investigation of the authenticity / genuineness of data (import of raw material and stability data),
manufacturing of stability batches and stability studies on these batches.
Tools for Investigation:
The investigation was conducted by using a structured questionnaire of DRAP. For objective evidence
physical inspection of the facilities for manufacturing and quality control, material used and retained, personnel
involved, ongoing studies, printed data and integrity and security of data in respective databases were also audited.
The details of investigation may be summarized as under:
Details of Investigation:
S.No Description Observation by panel
1
Do you have documents confirming
the import of API including
approval from DRAP?
The firm has imported Macrogol 3350 from M/s Avesta Pharma
and obtained proper approval from DRAP, Karachi, whereas
other ingredients like Sodium Chloride, Sodium Bicarbonate,
and Potassium Chloride are procured through local vendors.
2
Do you have any rationale behind
selecting the particular
manufacturer
There is proper vendor evaluation process being implemented by
the firm and the rationale behind vendor selection is controlled
through:
Postal Audit checklist
GMP approval by competent authority
3
Do you have documents confirming
the Import of Reference standard
and Impurities standards?
The firm has all the documents confirming the procurement of
APIs, reference standard and impurity standards.
4
Do you have certificate of analysis
of the API reference standard and
impurities standards?
The firm has Certificate of Analysis for APIs and working
standards.
5
Do you have any approval of API or
GMP certificate of manufacturer
issued by regulatory authority of
country of origin?
The firm has provided copy of GMP certificates for all the active
ingredients.
6
Do you use API manufacturer
method of Testing for testing of
API?
The firm has used USP method of testing for Macrogol 3350,
where European Pharmacopoeia method of testing for Sodium
Chloride, Sodium Bicarbonate and Potassium Chloride.
7
Do you have stability Studies
Report on API?
The firm has stability studies report of API Macrogol 3350,
Sodium Chloride, Sodium Bicarbonate, Potassium Chloride
conducted by API manufacturer.
Minutes of 294th Meeting of Registration Board | 120
8
If Yes, whether the stability testing
has been performed as per SIM
method and degradation products
have been quantified?
The manufacturer of API has performed the stability studies of
API as per Pharmacopoeial methods.
9 Do you have method for quantifying
the impurities in the API?
The firm has methods for quantifying the impurities in Macrogol
3350.
10
Do you have some remaining
quantities of the API, Its reference
standard and impurities standard?
The firm has remaining quantity API Macrogol 3350, Sodium
Chloride, Sodium Bicarbonate, Potassium Chloride their
reference standards and impurity standards.
11 Have you used pharmaceutical
grade excipients?
The firm has used pharmaceutical grade excipient i.e. Lime
flavour.
12 Do you have documents confirming
the import of the used excipients
The firm has documents confirming the procurement of the used
excipient.
13 Do you have test reports and other
records on the excipients?
The firm has test reports and other records on the excipient.
14
Do you have written and authorized
protocols for the development of
Movcol Paediatric Sachet?
The firm has written and authorized protocol for the
development of Movcol Paediatric Sachet.
15 Have you performed Drug-
Excipient compatibility studies?
Since firm has used same excipients as used by the innovator.
Therefore, compatibility studies were not performed.
16 Have you performed comparative
studies?
Firm has performed comparative studies with innovator Movicol
Junior.
17 Do you have Product Development /
R&D Section?
The firm has product development (R&D) Section with the
facility of manufacturing only whereas analysis part was
performed in routine Analytical Laboratory.
18
Do you have necessary equipment’s
available in product development
section for development of Movcol
Paediatric Sachet?
The firm has necessary equipment available in product
development section for development of tablets and inhalers
whereas the product in question is developed in routine
production area.
19 Are the equipment’s in product
development qualified?
The available equipment in Product Development are qualified.
20
Do you have proper maintenance
/calibration/re-qualification program
for the equipment used in PD?
There is proper maintenance / calibration program for the
equipment used in PD.
21
Do you have qualified staff in
product development section with
proper knowledge and training in
product development?
The firm has a team of 13 scientists including one PhD, one
MPhil, Chemists and Pharmacists for product development and
analytical method development and analysis of stability batches.
22
Have you manufactured three
stability batches for the stability
studies of Movcol Paediatric Sachet
as required?
The firm has manufactured three stability batches of each 1500
sachets.
Movcol Paediatric Sachet
Batch No Date of Mfg. Expiry Date
18SB-185-01 22-10-2018 22-10-2020
18SB-186-02 22-10-2018 22-10-2020
18SB-187-03 24-10-2018 24-10-2020
23
Do you have any criteria for fixing
the batch size of stability of batches?
The firm has SOP for fixing the batch size of stability batches
which include capacity of the R&D equipment and number of
sachets required per testing frequency and total testing
frequencies.
Minutes of 294th Meeting of Registration Board | 121
24 Do you have complete record of
production of stability batches?
The firm has complete record for the stability batches of Movcol
Paediatric Sachet.
25 Do you have protocols for stability
testing of stability batches.
The firm has protocols for testing of stability batches.
26
Do you have developed and
validated the method for testing of
stability batches
The firm has developed and validated method of testing of finish
product Movcol Paediatric Sachet, based on pharmacopoeial
method of testing of API.
27
Do you have method transfer studies
in case when the method of testing
being used by your firm is by any
other lab.
Method transfer studies is not applicable as the firm developed
and validated their own method.
28
Do you have documents confirming
the qualification of equipment /
instruments being used in the test
and analysis of the product’s API
and product Movcol Paediatric
Sachet?
The firm has proper documents confirming the qualification of
equipment / instruments being used in the test and analysis of the
Movcol Paediatric Sachet.
29 Do your method of analysis Stability
indicating?
The firm’s Method of analysis is Stability indicating.
30 Do your HPLC software 21CFR
compliant?
The HPLC software is 21CFR compliant.
31 Can you show audit trail reports on
Movcol Paediatric Sachet testing?
The firm has audit trail Reports on testing of macrogol 3350,
whereas other ingredients are analysed by titration method which
was confirmed by log books and analyst register.
32
Do you have some remaining
quantities of degradation products
and stability batches?
The firm has some remaining quantities of stability batches only.
33 Do you have batches kept on
stability testing?
The firm has three stability batches kept on stability for Real
time stability testing. Accelerated stability studies have been
completed.
34
Do you have valid calibration status
for the equipment’s used in Movcol
Paediatric Sachet production and
analysis?
The firm has valid calibration status for the equipment used in
Movcol Paediatric Sachet production and analysis.
35
Do Proper and Continuous
monitoring and control are available
for stability chamber?
Adequate monitoring and control are available for stability
chamber. Chambers are controlled and monitored through
software 21CFR compliance.
36
Do related manufacturing area,
equipment, personnel and utilities
be rated as GMP compliant?
Related manufacturing area, equipment, personnel and utilities
can be rated as GMP compliant.
37.
Any other query raised by PE&R
Division:
Procurement of API before
manufacturing of stability batches
The firm has procured all the APIs before manufacturing of
stability batches.
Conclusions:
1. On the basis of risk-based approach the genuineness / authenticity of stability data submitted by the firm
for registration of Movcol Paediatric Sachet (Macrogol 3350, Sodium Chloride, Sodium Bicarbonate,
and Potassium Chloride) is verifiable to satisfactory level.
2. The related manufacturing area, equipments, personnel and utilities are GMP compliant and are suited
for the manufacturing of Movcol Paediatric Sachet.
Decision: Registration Board decided to approve registration of Movcol Paediatric Sachet with
innovator’s specification by M/s Genix Pharma (Pvt) Ltd., 44, 45-B, Korangi Creek Road, Karachi.
Minutes of 294th Meeting of Registration Board | 122
Manufacturer will place first three production batches on long term stability studies throughout
proposed shelf life and on accelerated studies for six months.
Sr.
No.
Name & Address of
Manufacturer /
Applicant
Brand Name
(Proprietary Name + Dosage
Form + Strength),
Composition,
Pharmacological Group,
Finished Product Specification
Type of Form,
Initial Diary & Date,
Fee (including
differential fee),
Demanded Price /
Pack size
International Availability / Local
Availability
GMP Inspection Report Date &
Remarks
92. Ameer & Adnan
Pharmaceuticals
(Pvt) Ltd. Plot No.
47, Sundar
Industrial Estate,
Raiwind Road
Lahore.
Omdexo 30mg Capsule
Each capsule contains:
Dexlansoprazole (as dual
delayed release
pellets)….30mg
PPI
Form 5
Dy No. 8689
27-02-2019
PKR 20,000/-
(26-02-2019)
Dexilant Capsule (USFDA
Approved)
Last GMP inspection was
conducted on 29-11-2018 and the
report concludes satisfactory
level of GMP compliance.
Evaluation by PEC:
Firm has submitted accelerated and real time stability data of 6 months as per the requirement of
Registration Board.
STABILITY STUDY DATA
Drug Omdexo 30mg Capsule
Name of Manufacturer Ameer & Adnan Pharmaceuticals (Pvt) Ltd. Plot No. 47, Sundar Industrial
Estate, Raiwind Road Lahore.
Manufacturer of API Vision Pharmaceuticals, Islamabad
API Lot No. DLP420
Description of Pack
(Container closure system)
Alu-Alu foil blister sealed with aluminium foil. The blister are introduced into
unit carton.
Stability Storage Condition Real time : 30°C ± 2°C / 65% ± 5%RH
Accelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real time: 6 months Accelerated: 6 months
Frequency Accelerated: 0, 1, 3, 6 (Months) Real Time: 0, 3, 6 (Months)
Batch No. CZ-001 CZ-002 CZ-003
Batch Size 1900 capsule 1900 capsule 1900 capsule
Manufacturing Date 20-02-2019 20-02-2019 20-02-2019
Date of Initiation 22-02-2019 23-02-2019 25-02-2019
No. of Batches 03
Date of Submission Dy.# 16453 dated 02-09-2019
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
# Documents To Be Provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country
of origin or GMP certificate of API manufacturer
issued by regulatory authority of country of origin.
The firm was inspected on 11.02.2019, wherein the
panel recommended the grant of GMP certificate.
3. Protocols followed for conduction of stability study
and details of tests. Yes
4. Data of 03 batches will be supported by attested
respective documents like chromatograms,
laboratory reports, data sheets etc.
Yes
Minutes of 294th Meeting of Registration Board | 123
5. Documents confirming import of API etc. Firm has submitted copy of commercial invoice dated
11-02-2019 specifying purchase of 2 Kg of pellets.
6. All provided documents will be attested (name, sign
and stamp) for ensuring authenticity of data /
documents.
Yes
7. Commitment to continue real time stability study till
assigned shelf life of the product. Yes
8. Commitment to follow Drug Specification Rules,
1978. Yes
REMARKS OF EVALUATOR
Panel may be requested to verify the following
Testing of pellets at pH 1.2, 5.5 and 6.75/7 to confirm dual delayed release profile as per the decision of 276th
meeting of Registration Board.
Dissolution testing at buffer stage at pH 7.0 with 5mM SLS as per the FDA dissolution database.
Sr.
No.
Name & Address of
Manufacturer /
Applicant
Brand Name
(Proprietary Name + Dosage
Form + Strength),
Composition,
Pharmacological Group,
Finished Product Specification
Type of Form,
Initial Diary & Date,
Fee (including
differential fee),
Demanded Price /
Pack size
International Availability / Local
Availability
GMP Inspection Report Date &
Remarks
93. Ameer & Adnan
Pharmaceuticals
(Pvt) Ltd. Plot No.
47, Sundar
Industrial Estate,
Raiwind Road
Lahore.
Omdexo 60mg Capsule
Each capsule contains:
Dexlansoprazole (as dual
delayed release
pellets)….60mg
PPI
Form 5
Dy No. 8688
27-02-2019
PKR 20,000/-
(26-02-2019)
Dexilant Capsule (USFDA
Approved)
Last GMP inspection was
conducted on 29-11-2018 and the
report concludes satisfactory
level of GMP compliance.
Evaluation by PEC:
Firm has submitted accelerated and real time stability data of 6 months as per the requirement of
Registration Board.
STABILITY STUDY DATA
Drug Omdexo 60mg Capsule
Name of Manufacturer Ameer & Adnan Pharmaceuticals (Pvt) Ltd. Plot No. 47, Sundar Industrial
Estate, Raiwind Road Lahore.
Manufacturer of API Vision Pharmaceuticals, Islamabad
API Lot No. DLP420
Description of Pack
(Container closure system)
Alu-Alu foil blister sealed with aluminium foil. The blister are introduced into
unit carton.
Stability Storage Condition Real time : 30°C ± 2°C / 65% ± 5%RH
Accelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real time: 6 months
Accelerated: 6 months
Frequency Accelerated: 0, 1, 3, 6 (Months)
Real Time: 0, 3, 6 (Months)
Batch No. CZ-001 CZ-002 CZ-003
Batch Size 961 capsule 961 capsule 1900 capsule
Manufacturing Date 21-02-2019 21-02-2019 21-02-2019
Date of Initiation 26-02-2019 27-02-2019 27-02-2019
Minutes of 294th Meeting of Registration Board | 124
No. of Batches 03
Date of Submission Dy.# 16454 dated 02-09-2019
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
# Documents To Be Provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country
of origin or GMP certificate of API manufacturer
issued by regulatory authority of country of origin.
The firm was inspected on 11.02.2019, wherein the
panel recommended the grant of GMP certificate.
3. Protocols followed for conduction of stability study
and details of tests. Yes
4. Data of 03 batches will be supported by attested
respective documents like chromatograms, laboratory
reports, data sheets etc.
Yes
5. Documents confirming import of API etc. Firm has submitted copy of commercial invoice dated
11-02-2019 specifying purchase of 2 Kg of pellets.
6. All provided documents will be attested (name, sign
and stamp) for ensuring authenticity of data /
documents.
Yes
7. Commitment to continue real time stability study till
assigned shelf life of the product. Yes
8. Commitment to follow Drug Specification Rules,
1978. Yes
REMARKS OF EVALUATOR
Panel may be requested to verify the following
Testing of pellets at pH 1.2, 5.5 and 6.75/7 to confirm dual delayed release profile as per the decision of 276th
meeting of Registration Board.
Dissolution testing at buffer stage at pH 7.0 with 5mM SLS as per the FDA dissolution database.
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Omdexo 30mg
and 60mg capsules by M/s Ameer & Adnan, 47-Sunder industrial Estate, Lahore. The panel inspection of Ameer & Adnan, 47-Sunder industrial Estate, Lahore for verification of authenticity of
stability data of Omdexo 30mg and 60mg capsules was conducted on 07-11-2019 and 23-01-2020.
The panel comprised of
a) Shaheen Iqbal, Director, Drug Testing Laboratory, Lahore
b) Ufaq Tanveer Federal Inspector of Drugs, DRAP, Lahore
c) Anam Saeed Assistant Director, DRAP, Lahore.
S.
No.
Question Observation by Panel
1 Do you have documents confirming the import of
API including approval from DRAP?
The firm purchased API from M/s. Vision
Pharmaceuticals (Pvt) Ltd,
2 What was the rationale behind selecting the
particular manufacturer of API?
The rationale behind selecting the particular
manufacturer was its GMP compliant status and good
well in the market.
3 Do you have documents confirming the import
of reference standard and impurity standards?
Working standards and impurities standards were given
to the firm by M/s. Vision Pharmaceuticals (Pvt) Ltd,
4 No you have certificate of Analysis of the API,
reference standards and impurity standards
Yes
5 Do you have GMP certificate of API
manufacturer issued by regulatory authority of
country of origin?
Yes
Minutes of 294th Meeting of Registration Board | 125
6 Do you use API manufacturer method of testing
for testing API?
No. The firm developed its own method for testing of
API.
7 Do you have stability studies report of API? Yes. M/s. Vision Pharmaceuticals (Pvt) Ltd, Provided
stability studies on two batches of API.
8 If yes, whether the stability testing has been
performed as per SIM method and degradation
products have been quantified?
No.
9 Do you have method for quantifying the
impurities in the API?
Yes-HPLC was used for this purpose. In house method
was used.
10 Do you have some remaining quantities of the
API, its reference standard and impurities
standards?
No API was left Some quantity of working standard and
impurities standards were left.
11 Have you used pharmaceutical grade
excipients?
N/A
12 Do you have documents confirming the import
of the used excipients?
N/A
13 Do you have test reports and other records on
the excipients used?
N/A
14 Do you have written and authorized protocols
for the development of applied product?
SOP for product development was provided but product
development protocol was not developed.
15 Have you performed Drug-excipients
compatibility studies?
N/A
16 Have you performed comparative dissolution
studies?
Yes. However, the firm purchased reference product
from M/s. Sami Pharmaceuticals (Delanzo) not from the
innovator. The innovator comparative dissolution profile
was incomplete. Testing at buffer PH 5.5 was missing
for accelerated study stability batches. It was advised to
do dissolution at PH 5.5 for the remaining quantities of
stability hatches.
17 Do you have product development (R&D)
section
Yes.
18 Do you have necessary equipments available in
product development section for development
of applied product?
No. Firm utilized production area of capsules section for
manufacturing their product.
19 Are the equipments in product development
section qualified?
Yes
20 Do you have proper maintenance / calibration /
re-qualification program for the equipment used
in PD section?
Yes
21 Do you have qualified staff in product
development section with proper knowledge
and training in product development?
Yes.
List attached.
22 Have you manufactured three stability batches
for the stability studies of applied product as
required.
Yes.
Omdexo 30mg Omdexo 60mg
CZ-001 1900 CZ-001 961
CZ-002 1900 CZ-002 961
CZ-003 1900 CZ-003 961
23 Do you have any criteria for fixing the batch size
of stability batches?
As per stability protocol.
24 Do you have complete record of production of
stability batches?
Yes
25 Do you have protocols for stability testing of
stability batches?
Yes
Minutes of 294th Meeting of Registration Board | 126
26 Do you have developed and validated the
method for testing of stability batches.
Firm had developed its own method but the method was
not stability indicating.
27 Do you have method transfer studies in case
when the method of testing being used by your
firm is given by any other lab?
N/A
28 Do you have documents confirming the
qualification of equipments / instruments being
used in the test and analysis of API and the
finished drugs?
Yes.
29 Is your method of analysis stability indicating? No.
Is your HPLC software is 21CFR compliant? No.
30 (Details of Model, software, description/version
(i.e. software validation report for 21 CFR Part
11 compliance including audit trail, password
protection, date & time lock and user
authorizations shall also be reported).
No.
31 Can you show Audit Trail reports on stability
studies testing?
No.
32 Do you have some remaining quantities of
degradation products and stability batches?
Yes.
Stability batches are still in stability chamber.
33 Do you have stability batches kept on stability
testing?
Yes.
For long term stability.
34 Do you have valid calibration status for the
equipments used in production and analysis?
Yes.
35 Do proper and continuous monitoring and
control are available for stability chamber?
(Number and utilized/available capacity of
stability chambers shall also be reported).
Yes.
36 Do related manufacturing area, equipment,
personnel and utilities berated as GMP
compliant?
Yes.
Conclusion:
The panel inspection of Ameer & Adnan, 47-Sunder industrial Estate, Lahore for verification of
authenticity of stability data of Omdexo 30mg and 60mg capsules was conducted on 07-11-2019 and 23-01-2020
and the details are as given above. The panel also verified the following.
i) Testing of pellets at pH 1.2,5.5 and 6.75/7 to confirm dual delayed release profile as per the decision
of 276th meeting of Registration Board.
ii) Dissolution testing at buffer stage at pH 7.0 with 5mM SLS as per the FDA dissolution database.
However it seems from the data that the firm did not perform accelerated salability studies testing at PH 5.5. Also
the firm developed its own method for testing of raw material and stability batches. The detailed report is being
submitted to the competent authority for further consideration.
Discussion: Registration Board deliberated on the analytical method adopted by the firm and reiterated that the
firm can either adopt the API manufacturer’s method of testing (since it is a validated method) or develop and
validate analytical method based on ICH guidelines. The Board further deliberated that in any case the analytical
method should be properly validated.
Decision: Registration Board decided to defer the case of Omdexo 30mg and 60mg capsules for
submission of data of validation of analytical method since the firm has not used API
manufacturer’s method of testing.
Minutes of 294th Meeting of Registration Board | 127
b. Exemption from onsite verification of stability data
New Cases
Sr.
No.
Name & Address of
Manufacturer /
Applicant
Brand Name
(Proprietary Name +
Dosage Form + Strength),
Composition,
Pharmacological Group,
Finished Product
Specification
Type of Form,
Initial Diary & Date,
Fee (including
differential fee),
Demanded Price /
Pack size
International Availability /
Local Availability
GMP Inspection Report Date
94. Getz Pharma (Pvt) Ltd.
29-30/27, Korangi
Industrial Area,
Karachi.
Vonoget 10mg Tablet
Each film coated tablet
contains:
Vonoprazan as
fumarate…..10mg
Potassium-Competitive
Acid Blocker
Form 5D
03-08-2018
PKR 50,000/-
03-08-2018
Takecab Tablets
(PMDA Japan Approved)
01-07-2019: acceptable level of
compliance of GMP
requirements.
STABILITY STUDY DATA
Drug Vonoget 10mg Tablet
Name of Manufacturer M/s Getz Pharma (Pvt) Ltd. 29-30/27, Korangi Industrial Area, Karachi.
Manufacturer of API Jiangsu Yongan Pharmaceutical Co. Ltd. No. 18, 237 Provincial Highway, Jiangsu
Hua’ian Economic Development Zone, China.
API Lot No. 20180812
Description of Pack
(Container closure system)
Red coloured, oblong shaped, biconvex film coated tablet plain on both sides packed
in Alu-PVC blister, further packed in secondary carton.
Stability Storage Condition Accelerated: 40°C ± 2°C/75%±5% RH
Real Time: 30°C ± 2°C/65%±5% RH
Time Period Accelerated: 6 (months) Real Time: 6 (months)
Frequency Accelerated: 0, 1, 2, 3, 4, 6 (Months) Real Time : 0, 3, 6 (Months)
Batch No. 454DS01 454DS02 454DS03
Batch Size 5000 Tablets 5000 Tablets 5000 Tablets
Manufacturing Date 12 – 2018 12 – 2018 12 – 2018
Date of Initiation 01-01-2019 07-01-2019 08-01-2019
No. of Batches 03
Date of Submission 21125 (18-10-2019)
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr.# Documents To Be Provided Status
1. COA of API. Yes
2. Approval of API by regulatory authority of
country of origin or GMP certificate of API
manufacturer issued by regulatory authority of
country of origin.
Firm has submitted copy of GMP certificate No.
JS20160548 issued by China Food and Drug
Administration which is valid till 03-03-2021.
3. Protocols followed for conduction of stability
study and details of tests.
Yes
4. Data of 03 batches will be supported by attested
respective documents like chromatograms,
laboratory reports, data sheets etc.
Yes
Minutes of 294th Meeting of Registration Board | 128
5. Documents confirming import of API etc. Firm has submitted copy of commercial invoice dated 05-
09-2018 specifying import of 2.5Kg Vonoprazan
Fumarate attested by AD DRAP, Karachi.
6. All provided documents will be attested (name,
sign and stamp) for ensuring authenticity of data
/ documents.
Yes
7. Commitment to continue real time stability study
till assigned shelf life of the product.
Yes
8. Commitment to follow Drug Specification Rules,
1978.
Yes
REQUEST OF EXEMPTION FROM ON SITE INSPECTION
The firm has requested for Exemption from On-site Investigation of their submitted stability data and provided the
following documents in conjunction with the checklist approved by the Registration Board in its 278th Meeting:
Administrative Portion
1. Reference of last onsite panel
inspection for instant dosage form
conducted during last two years.
Firm has referred to their last onsite inspection conducted for
product Arcox Tablet 90mg and 120mg on 17th September, 2018.
The said inspection report was discussed in 286th meeting of
Registration Board held on 14-16th November 2018 and the case was
approved. The inspection report confirms following points:
The HPLC software is 21CFR Compliant as per record available
with the firm.
Audit trail on the testing reports is available.
Adequate monitoring and control are available for stability chamber.
Chambers are controlled and monitored through software having
alarm system for alerts as well.
Related manufacturing area, equipment, personnel and utilities are
GMP compliant.
2. Documents for the procurement of
API with approval from DRAP (in
case of import).
Firm has submitted copy of commercial invoice dated 05-09-2018
specifying import of 2.5Kg Vonoprazan Fumarate attested by AD
DRAP, Karachi.
3. Documents for the procurement of
reference standard and impurity
standards.
The firm has submitted an undertaking specifying that we have
procured reference standard of vonoprazan Fumarate Batch No.
20171128 and impurity standards as free of cost sample from the API
manufacturer. We have used Relative Retention Time for location and
calculation of related substance as provided by API manufacturer.
Firm has also submitted copy of invoice for reference standard (0.5g)
and Impurities i.e. Z-1-5mg, Z-3-5mg, Z-7-15mg and Z-8-5mg.
4. Approval of API/ DML/GMP
certificate of API manufacturer issued
by regulatory authority of country of
origin.
Firm has submitted copy of GMP certificate No. JS20160548 issued
by China Food and Drug Administration which is valid till 03-03-
2021.
5. Mechanism for Vendor pre-
qualification
Firm has submitted copy of vendor certification checklist filled and
signed by technical persons of the firm in April 2018, before the
import of API.
6. Certificate of analysis of the API,
reference standards and impurity
standards.
Firm has submitted analytical report and copy of COA of API and
reference and impurity standard.
7. Documents for the procurement of
excipients used in product
development?
The firm has submitted documents for procurement of excipients used
in the formulation of applied product.
Minutes of 294th Meeting of Registration Board | 129
8. List of qualified staff involved in
product development with relevant
experience.
The firm has submitted List of qualified staff involved in R&D
department.
Production Data
9. Authorized Protocols/SOP for the
development & stability testing of
trial batches.
The firm has submitted copy of protocols for stability study of primary
batches of vonoprazan tablets.
10. Complete batch manufacturing record
of three stability batches.
The firm has submitted copy of Batch Manufacturing Records of all
the three Batches.
11. Record of remaining quantities of
stability batches.
Firm has provided following remaining quantities for each batch:
454DS01: 14 Packs
454DS02: 14 Packs
454DS03: 14 Packs
QA / QC DATA
12. Record of Digital data logger for
temperature and humidity monitoring
of stability chambers (real time and
accelerated)
Firm has submitted copies of data logger record for stability chambers
with real time and accelerated stability testing
Method used for analysis of API
along with COA.
The firm has submitted copy of Raw Material Specifications, Raw
Material Testing Procedures along with COA.
13. Method used for analysis of FPP &
complete record of testing of stability
batches (i.e. chromatograms, lab
reports, raw data sheets etc.)
The firm has submitted copy of Finished Product Testing Procedure
and specification.
14. Reports of stability studies of API
from manufacturer.
The firm have submitted stability study data of 3 batches as per
conditions of zone IV-A.
15. Analysis reports for excipients used. Firm has submitted analysis reports for all excipients used in applied
product development
16. Drug-excipients compatibility
studies.
Firm has submitted that they have used same excipients in their
formulation as used by the innovator “Takecab” Tablets. The only
difference is in film coating material. Therefore drug-excipient
compatibility studies are not required.
17. Record of comparative dissolution
data.
Firm has submitted comparative dissolution profile data at 1.2 pH
HCl, 4.5 pH acetate buffer and 6.8 pH phosphate buffer. The
dissolution is reported to be more than 85% in 15 minutes in all
dissolution medium.
18. Compliance Record of HPLC
software 21CFR & audit trail reports
on product testing.
Audit trail on testing reports for the applied product has been
submitted by the firm.
Remarks of the evaluator:
Shortcoming communicated
Justify the adaptation of dissolution parameters including type of apparatus, speed (rpm), dissolution medium,
volume and time keeping in view the solubility and pKa of the drug substance, pH – pKa solubility profile and
recommendations from general chapters of official pharmacopoeia.
Response by the firm:
Vonoprazan is a highly soluble drug substance based on ICH Q6A, which states that the drug substance should
be considered highly soluble if it meets following two conditions:
1. The dissolution profile of all strengths of the dosage form should be rapid i.e. Dissolution >80 % in 15
minutes at pH 1.2, 4.0 & 6.8.
Minutes of 294th Meeting of Registration Board | 130
2. The highest drug product’s strength is soluble in 250mL or less of aqueous media over the pH range of 1.2
to 6.8 at 37°C ± 1°C. In other words, the highest strength divided by 250 should be less than or equal to the
lowest solubility observed over the entire pH range of 1.2 - 6.8 i.e. dose/solubility volume < 250 mL from
pH 1.2 to 6.8.
As per ICH Q6A, for dosage forms having drug substances falls in above conditions will be considered as highly
soluble drugs and do not require development of discriminatory dissolution method / parameters. Generally, a
single time point with one medium is acceptable.
Getz Pharma Product ‘Vonoget Tablets’ as well as the Innovator Product ‘Takecab Tablets’ releases more than
85% in all three mediums within 15minutes at 50 RPM. Also, the dose solubility of Vonoprazan is very high
throughout the physiological pH range (1.2 to 6.8). The lowest solubility of Vonoprazan is found to be in pH
6.8 i.e. is about 4.7 mg/ml which is greater than the highest strength divided by 250 (20mg/250=0.08mg/ml).
Based on above literature and studies, we selected dissolution medium having pH 6.8 as a worst-case scenario,
since the solubility of Vonoprazan in pH 6.8 is less as compared to solubility in pH 1.2 (about 16.5mg/ml) & pH
4.5 (8.1mg/ml).
In light of above discussion and high solubility of drug substance, discriminatory dissolution parameters is not
required for Vonoprazan Tablets 10mg and 20mg. Therefore, generalized lowest 50 RMP with 900ml medium
(most common volume as per USP <1092>) was selected for release and stability studies of the drug product.
As per USP general chapter <1092>, “Dissolution Procedure: Development and Validation”, Immediate release
dosage form should release within 30 to 60 minutes. Therefore, we selected the lowest time point i.e. 30 minutes
for dissolution.
Decision: Registration Board decided to approve registration of Vonoget 10mg Tablet with
innovator’s specification by M/s Getz Pharma (Pvt) Ltd. 29-30/27, Korangi Industrial Area,
Karachi. Manufacturer will place first three production batches on long term stability studies
throughout proposed shelf life and on accelerated studies for six months.
Sr.
No.
Name & Address of
Manufacturer /
Applicant
Brand Name
(Proprietary Name +
Dosage Form + Strength),
Composition,
Pharmacological Group,
Finished Product
Specification
Type of Form,
Initial Diary & Date,
Fee (including
differential fee),
Demanded Price /
Pack size
International Availability /
Local Availability
GMP Inspection Report Date
95. Getz Pharma (Pvt) Ltd.
29-30/27, Korangi
Industrial Area,
Karachi.
Vonoget 20mg Tablet
Each film coated tablet
contains:
Vonoprazan as
fumarate…..20mg
Potassium-Competitive
Acid Blocker
Form 5D
03-08-2018
PKR 50,000/-
03-08-2018
Takecab Tablets
(PMDA Japan Approved)
01-07-2019: acceptable level of
compliance of GMP
requirements.
STABILITY STUDY DATA
Drug Vonoget 20mg Tablet
Name of Manufacturer M/s Getz Pharma (Pvt) Ltd. 29-30/27, Korangi Industrial Area, Karachi.
Manufacturer of API Jiangsu Yongan Pharmaceutical Co. Ltd. No. 18, 237 Provincial Highway, Jiangsu
Hua’ian Economic Development Zone, China.
API Lot No. 20180812
Description of Pack
(Container closure system)
Red coloured, oblong shaped, biconvex film coated tablet plain on both sides packed
in Alu-PVC blister, further packed in secondary carton.
Stability Storage Condition Accelerated: 40°C ± 2°C/75%±5% RH
Real Time: 30°C ± 2°C/65%±5% RH
Time Period Accelerated: 6 (months) Real Time: 6 (months)
Frequency Accelerated: 0, 1, 2, 3, 4, 6 (Months) Real Time : 0, 3, 6 (Months)
Minutes of 294th Meeting of Registration Board | 131
Batch No. 455DS01 455DS02 455DS03
Batch Size 2500 Tablets 2500 Tablets 2500 Tablets
Manufacturing Date 12 – 2018 12 – 2018 12 – 2018
Date of Initiation 01-01-2019 07-01-2019 08-01-2019
No. of Batches 03
Date of Submission 21126 (18-10-2019)
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr.# Documents To Be Provided Status
1. COA of API. Yes
2. Approval of API by regulatory authority of
country of origin or GMP certificate of API
manufacturer issued by regulatory authority of
country of origin.
Firm has submitted copy of GMP certificate No.
JS20160548 issued by China Food and Drug
Administration which is valid till 03-03-2021.
3. Protocols followed for conduction of stability
study and details of tests.
Yes
4. Data of 03 batches will be supported by attested
respective documents like chromatograms,
laboratory reports, data sheets etc.
Yes
5. Documents confirming import of API etc. Firm has submitted copy of commercial invoice dated 05-
09-2018 specifying import of 2.5Kg Vonoprazan
Fumarate attested by AD DRAP, Karachi.
6. All provided documents will be attested (name,
sign and stamp) for ensuring authenticity of data
/ documents.
Yes
7. Commitment to continue real time stability study
till assigned shelf life of the product.
Yes
8. Commitment to follow Drug Specification Rules,
1978.
Yes
REQUEST OF EXEMPTION FROM ON SITE INSPECTION
The firm has requested for Exemption from On-site Investigation of their submitted stability data and provided the
following documents in conjunction with the checklist approved by the Registration Board in its 278th Meeting:
Administrative Portion
1. Reference of last onsite panel
inspection for instant dosage form
conducted during last two years.
Firm has referred to their last onsite inspection conducted for product
Arcox Tablet 90mg and 120mg on 17th September, 2018. The said
inspection report was discussed in 286th meeting of Registration
Board held on 14-16th November 2018 and the case was approved.
The inspection report confirms following points:
The HPLC software is 21CFR Compliant as per record available
with the firm.
Audit trail on the testing reports is available.
Adequate monitoring and control are available for stability chamber.
Chambers are controlled and monitored through software having
alarm system for alerts as well.
Related manufacturing area, equipment, personnel and utilities are
GMP compliant.
Minutes of 294th Meeting of Registration Board | 132
2. Documents for the procurement of
API with approval from DRAP (in
case of import).
Firm has submitted copy of commercial invoice dated 05-09-2018
specifying import of 2.5Kg Vonoprazan Fumarate attested by AD
DRAP, Karachi.
3. Documents for the procurement of
reference standard and impurity
standards.
The firm has submitted an undertaking specifying that we have
procured reference standard of vonoprazan Fumarate Batch No.
20171128 and impurity standards as free of cost sample from the API
manufacturer. We have used Relative Retention Time for location and
calculation of related substance as provided by API manufacturer.
Firm has also submitted copy of invoice for reference standard (0.5g)
and Impurities i.e. Z-1-5mg, Z-3-5mg, Z-7-15mg and Z-8-5mg.
4. Approval of API/ DML/GMP
certificate of API manufacturer
issued by regulatory authority of
country of origin.
Firm has submitted copy of GMP certificate No. JS20160548 issued
by China Food and Drug Administration which is valid till 03-03-2021.
5. Mechanism for Vendor pre-
qualification
Firm has submitted copy of vendor certification checklist filled and
signed by technical persons of the firm in April 2018, before the import
of API.
6. Certificate of analysis of the API,
reference standards and impurity
standards
Firm has submitted analytical report and copy of COA of API and
reference and impurity standard.
7. Documents for the procurement of
excipients used in product
development?
The firm has submitted documents for procurement of excipients used
in the formulation of applied product.
8. List of qualified staff involved in
product development with relevant
experience.
The firm has submitted List of qualified staff involved in R&D
department.
Production Data
9. Authorized Protocols/SOP for the
development & stability testing of
trial batches.
The firm has submitted copy of protocols for stability study of primary
batches of vonoprazan tablets.
10. Complete batch manufacturing
record of three stability batches.
The firm has submitted copy of Batch Manufacturing Records of all
the three Batches.
11. Record of remaining quantities of
stability batches.
Firm has provided following remaining quantities for each batch:
455DS01: 10 Packs
455DS02: 11 Packs
455DS03: 10 Packs
QA / QC DATA
12. Record of Digital data logger for
temperature and humidity
monitoring of stability chambers
(real time and accelerated)
Firm has submitted copies of data logger record for stability chambers
with real time and accelerated stability testing
Method used for analysis of API
along with COA.
The firm has submitted copy of Raw Material Specifications, Raw
Material Testing Procedures along with COA.
13. Method used for analysis of FPP &
complete record of testing of stability
batches (i.e. chromatograms, lab
reports, raw data sheets etc.)
The firm has submitted copy of Finished Product Testing Procedure
and specification.
14. Reports of stability studies of API
from manufacturer.
The firm have submitted stability study data of 3 batches as per
conditions of zone IV-A.
15. Analysis reports for excipients used. Firm has submitted analysis reports for all excipients used in applied
product development
Minutes of 294th Meeting of Registration Board | 133
16. Drug-excipients compatibility
studies.
Firm has submitted that they have used same excipients in their
formulation as used by the innovator “Takecab” Tablets. The only
difference is in film coating material. Therefore drug-excipient
compatibility studies are not required.
17. Record of comparative dissolution
data.
Firm has submitted comparative dissolution profile data at 1.2 pH HCl,
4.5 pH acetate buffer and 6.8 pH phosphate buffer. The dissolution is
reported to be more than 85% in 15 minutes in all dissolution medium.
18. Compliance Record of HPLC
software 21CFR & audit trail reports
on product testing.
Audit trail on testing reports for the applied product has been submitted
by the firm.
Remarks of the evaluator:
Shortcoming communicated
Justify the adaptation of dissolution parameters including type of apparatus, speed (rpm), dissolution medium,
volume and time keeping in view the solubility and pKa of the drug substance, pH – pKa solubility profile and
recommendations from general chapters of official pharmacopoeia.
Response by the firm:
Vonoprazan is a highly soluble drug substance based on ICH Q6A, which states that the drug substance should
be considered highly soluble if it meets following two conditions:
1. The dissolution profile of all strengths of the dosage form should be rapid i.e. Dissolution >80 % in 15
minutes at pH 1.2, 4.0 & 6.8.
2. The highest drug product’s strength is soluble in 250mL or less of aqueous media over the pH range of
1.2 to 6.8 at 37°C ± 1°C. In other words, the highest strength divided by 250 should be less than or
equal to the lowest solubility observed over the entire pH range of 1.2 - 6.8 i.e. dose/solubility volume
< 250 mL from pH 1.2 to 6.8.
As per ICH Q6A, for dosage forms having drug substances falls in above conditions will be considered as highly
soluble drugs and do not require development of discriminatory dissolution method / parameters. Generally, a
single time point with one medium is acceptable.
Getz Pharma Product ‘Vonoget Tablets’ as well as the Innovator Product ‘Takecab Tablets’ releases more than
85% in all three mediums within 15minutes at 50 RPM. Also, the dose solubility of Vonoprazan is very high
throughout the physiological pH range (1.2 to 6.8). The lowest solubility of Vonoprazan is found to be in pH
6.8 i.e. is about 4.7 mg/ml which is greater than the highest strength divided by 250 (20mg/250=0.08mg/ml).
Based on above literature and studies, we selected dissolution medium having pH 6.8 as a worst-case scenario,
since the solubility of Vonoprazan in pH 6.8 is less as compared to solubility in pH 1.2 (about 16.5mg/ml) &
pH 4.5 (8.1mg/ml).
In light of above discussion and high solubility of drug substance, discriminatory dissolution parameters is not
required for Vonoprazan Tablets 10mg and 20mg. Therefore, generalized lowest 50 RMP with 900ml medium
(most common volume as per USP <1092>) was selected for release and stability studies of the drug product.
As per USP general chapter <1092>, “Dissolution Procedure: Development and Validation”, Immediate release
dosage form should release within 30 to 60 minutes. Therefore, we selected the lowest time point i.e. 30 minutes
for dissolution.
Decision: Registration Board decided to approve registration of Vonoget 20mg Tablet with
innovator’s specification by M/s Getz Pharma (Pvt) Ltd. 29-30/27, Korangi Industrial Area,
Karachi. Manufacturer will place first three production batches on long term stability studies
throughout proposed shelf life and on accelerated studies for six months.
Minutes of 294th Meeting of Registration Board | 134
Sr.
No.
Name & Address of
Manufacturer /
Applicant
Brand Name
(Proprietary Name + Dosage
Form + Strength), Composition,
Pharmacological Group,
Finished Product Specification
Type of Form,
Initial Diary & Date,
Fee (including
differential fee),
Demanded Price /
Pack size
International Availability
GMP Inspection Report
Date & Remarks
96. M/s Hilton Pharma
(Pvt) Ltd., Plot 13 &
14, Sector 15, Korangi
Industrial Area,
Karachi
Dapa-Met XR 2.5/1000mg
tablets
Each film coated bilayer tablet
contains:
Dapagliflozin (as propanediol
monohydrate) …… 2.5 mg
Metformin hydrochloride
(Extended release)…. 1000mg
(Antidiabetic)
Form 5-D
Diary No. 103
27-01-2016.
Rs.50,000/- dated
27-01-2016
Approved by USFDA
Last GMP inspection was
conducted on 19-07-2017
& report concludes
satisfactory level of GMP
compliance
97. M/s Hilton Pharma
(Pvt) Ltd., Plot 13 &
14, Sector 15, Korangi
Industrial Area,
Karachi
Dapa-Met XR 5/500mg tablets
Each film coated bilayer tablet
contains:
Dapagliflozin (as propanediol
monohydrate) …… 5 mg
Metformin hydrochloride
(Extended release)…. 500mg
(Antidiabetic)
Form 5-D
Dy. No. 102
27-01-2016.
Rs.50,000/-
27-01-2016
98. M/s Hilton Pharma
(Pvt) Ltd., Plot 13 &
14, Sector 15, Korangi
Industrial Area,
Karachi
Dapa-Met XR 10/500mg tablets
Each film coated bilayer tablet
contains:
Dapagliflozin (as propanediol
monohydrate) …… 10 mg
Metformin hydrochloride
(Extended release)…. 500mg
(Antidiabetic)
Form 5-D
Dy. No. 104
27-01-2016.
Rs.50,000/-
27-01-2016
Remarks of Evaluator:
The firm has submitted stability study data along with required documents as per checklist approved in 251st
meeting of Registration Board. Detailsof submitted data are as under:
(Dy.# 24048 dated 15-11-2019)
STABILITY STUDY DATA
Manufacturer of API Dapagliflozin: Jiangsu Yongan Pharmaceutical Co. Ltd., China.
Metformin hydrochloride: Abhilash Chemicals & Pharmaceuticals (Pvt.)
Ltd., India.
API Lot No. Dapagliflozin: 201806001
Metformin: MET/01/18061066
Description of Pack
(Container closure system)
Alu-Alu blister foil with unit carton
Stability Storage Condition Accelerated: 40°C ± 2°C / 75% ± 5%RH
Real Time: 30°C ± 2°C / 65% ± 5%RH
Time Period Accelerated: 6 Months
Real Time: 6 Months
Frequency Real Time: 0,3 & 6 (months)
Accelerated: 0,3 & 6 (months)
DAPA-MET XR 2.5/1000MG TABLET
Minutes of 294th Meeting of Registration Board | 135
Batch No. DMX-309106-19 DMX-309206-20 DMX-309306-21
Batch Size 1500 Tablets 1500 Tablets 1500 Tablets
Manufacturing Date 03-2019 03-2019 03-2019
Date of Initiation 08-04-2019 08-04-2019 08-04-2019
DAPA-MET XR 5/500MG TABLET
Batch No. DMX-286109-6 DMX-286009-5 DMX-285909-4
Batch Size 1500 Tablets 1500 Tablets 1500 Tablets
Manufacturing Date 09-2018 09-2018 09-2018
Date of Initiation 26-10-2018 26-10-2018 26-10-2018
DAPA-MET XR 10/500MG TABLET
Batch No. DMX-290011-18 DMX-289911-17 DMX-289811-16
Batch Size 1500 Tablets 1500 Tablets 1500 Tablets
Manufacturing Date 11-2018 11-2018 11-2018
Date of Initiation 15-12-2018 15-12-2018 15-12-2018
No. of Batches 03
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Documents To Be Provided Status
COA of API Yes
Approval of API by regulatory authority of country of
origin or GMP certificate of API manufacturer issued
by regulatory authority of country of origin.
Dapagliflozin: Firm has submitted copy of GMP
certificate (No. JS20160548) of M/s Jiangsu Yongan
Pharmaceutical Co. Ltd, issued by CFDA China. The
certificate is valid till 3-3-2021.
Metformin: Firm has submitted copy of GMP certificate
(No. WC-0345) of M/s Abhilash Chemicals issued by
Central Drugs Standard Control Organization,
Government of India. The certificate is valid till 27-09-
2021.
Protocols followed for conduction of stability study and
details of tests. Yes
Data of 03 batches will be supported by attested
respective documents like chromatograms, laboratory
reports, data sheets etc.
Yes
Documents confirming import of API etc. Dapagliflozin: Firm has submitted copy of commercial
invoice dated 16-7-2018 specifying import of 75 Kg
dapagliflozin propanediol monohydrate. The invoice has
been signed by AD DRAP Karachi.
Metformin: Firm has submitted copy of commercial
invoice dated 27-6-2018 specifying import of 5000 Kg
metformin HCl. The invoice is signed by AD DRAP
Karachi.
All provided documents will be attested (name, sign
and stamp) for ensuring authenticity of data /
documents.
Yes
Commitment to continue real time stability study till
assigned shelf life of the product. Yes
Minutes of 294th Meeting of Registration Board | 136
Commitment to follow Drug Specification Rules, 1978. Yes
DATA FOR EXEMPTION FROM ONSITE INVESTIGATION OF SUBMITTED STABILITY DATA
ADMINISTRATIVE PORTION
1. Reference of last onsite panel
inspection for instant dosage
form conducted during last two
years.
Firm has referred to last onsite inspection of their product HILVEL Tablets
(Sofosbuvir / Velpatasvir) which was considered and approved by
Registration Board in its 277th Meeting with following details:
Date of Inspection: 14-12-2017.
The HPLC is 21CFR Compliant.
Audit trail on the testing reports were available.
2. Documents for the procurement
of API with approval from
DRAP (in case of import).
Dapagliflozin: Firm has submitted copy of commercial invoice dated 16-7-
2018 specifying import of 75 Kg dapagliflozin propanediol monohydrate.
The invoice has been signed by AD DRAP Karachi.
Metformin: Firm has submitted copy of commercial invoice dated 27-6-
2018 specifying import of 5000 Kg metformin HCl. The invoice is signed
by AD DRAP Karachi.
3. Documents for the procurement
of reference standard and
impurity standards.
Firm has submitted copy of invoice of purchase of working reference
standard and impurity.
4. Approval of API/ DML/GMP
certificate of API manufacturer
issued by regulatory authority
of country of origin.
Dapagliflozin: Firm has submitted copy of GMP certificate (No.
JS20160548) of M/s Jiangsu Yongan Pharmaceutical Co. Ltd, issued by
CFDA China. The certificate is valid till 3-3-2021.
Metformin: Firm has submitted copy of GMP certificate (No. WC-0345)
of M/s Abhilash Chemicals issued by Central Drugs Standard Control
Organization, Government of India. The certificate is valid till 27-09-2021.
5. Mechanism for Vendor pre-
qualification
Firm has submitted copy of vendor’s audit form and SOPs for selection of
vendor.
6. Certificate of analysis of the
API, reference standards and
impurity standards
Firm has submitted COA of API, and reference standard.
7. Documents for the procurement
of excipients used in product
development?
Firm has submitted documents for procurement of excipients.
8. List of qualified staff involved
in product development with
relevant experience.
Firm has provided list of technical staff of product development section.
PRODUCTION DATA
9. Authorized Protocols/SOP for
the development & stability
testing of trial batches.
Firm has submitted authorized general protocols/SOPs for the development
& testing of trial batches.
10. Complete batch manufacturing
record of three stability batches.
Firm has provided Batch Manufacturing Record for all the three batches
11. Record of remaining quantities
of stability batches.
Firm has provided following remaining quantities for each batch:
DAPA-MET XR 2.5/1000MG TABLET
DMX-309106-19: 140 Tablets
DMX-309206-20: 140 Tablets
DMX-309306-21: 140 Tablets
DAPA-MET XR 5/500MG TABLET
DMX-285909-4: 84 Tablets
DMX-286009-5: 84 Tablets
DMX-286109-6: 84 Tablets
Minutes of 294th Meeting of Registration Board | 137
DAPA-MET XR 10/500MG TABLET
DMX-289811-16: 112 Tablets
DMX-289911-17: 112 Tablets
DMX-290011-18: 112 Tablets
QA/QC DATA
12. Record of Digital data logger
for temperature and humidity
monitoring of stability
chambers (real time and
accelerated)
Firm has submitted record of Digital data logger for temperature and
humidity monitoring of stability chambers.
13. Method used for analysis of API
along with COA.
Firm has submitted COA and method of analysis of API.
14. Method used for analysis of
FPP & complete record of
testing of stability batches (i.e.
chromatograms, lab reports,
raw data sheets etc.)
Firm has submitted method of analysis of FPP and complete record of
testing of stability batches along with chromatograms
15. Reports of stability studies of
API from manufacturer.
Firm has submitted both accelerated (40°C ± 2°C & 75±5%RH) stability
studies & long term (30°C ± 2°C & 65±5%RH) stability studies reports of
three batches of both API’s.
16. Analysis reports for excipients
used.
Firm has submitted analysis reports for all excipients used.
17. Drug-excipients compatibility
studies.
Firm has submitted that their formulation is as per reference product so they
do not require drug excipient compatibility studies.
18. Record of comparative
dissolution data. Firm has submitted data of comparative dissolution profile at pH 1.2
buffer, 4.5 buffer, 6.8.phosphate buffer and calculated difference of %
release with innovator product and also calculated f2 factor. The value of
f2 factor in all dissolution medium for all the strengths fall in acceptable
range.
19. Compliance Record of HPLC
software 21CFR & audit trail
reports on product testing.
Firm has submitted audit trail reports for HPLC analysis for all the three
batches.
Evaluation by PEC:
Decision: Registration Board decided to approve registration of Dapa-Met XR 2.5/1000mg tablets,
Dapa-Met XR 5/500mg tablets and Dapa-Met XR 10/500mg tablets with innovator’s specification
by M/s Hilton Pharma (Pvt) Ltd., Plot 13 & 14, Sector 15, Korangi Industrial Area, Karachi.
Manufacturer will place first three production batches on long term stability studies throughout
proposed shelf life and on accelerated studies for six months.
Sr.
No.
Name & Address of
Manufacturer /
Applicant
Brand Name
(Proprietary Name + Dosage
Form + Strength), Composition,
Pharmacological Group,
Finished Product Specification
Type of Form,
Initial Diary & Date,
Fee (including
differential fee),
Demanded Price /
Pack size
International Availability
GMP Inspection Report
Date & Remarks
99. M/s Hilton Pharma
(Pvt) Ltd., Plot 13 &
14, Sector 15, Korangi
Industrial Area,
Karachi
Empa-Met XR 5/1000mg tablet
Each film coated tablet contains:
Empagliflozin …….. 5 mg
Metformin hydrochloride
(Extended release)…..1000mg
(Antidiabetic)
Form 5-D
Diary No. 2740
24-02-2017
PKR.50,000/-
23-02-2017
Approved by USFDA
Last GMP inspection was
conducted on 19-7-2017
and the report concludes
satisfactory level of GMP
compliance
Minutes of 294th Meeting of Registration Board | 138
100. M/s Hilton Pharma
(Pvt) Ltd., Plot 13 &
14, Sector 15, Korangi
Industrial Area,
Karachi
Empa-Met XR 10/1000mg tablet
Each film coated tablet contains:
Empagliflozin …….. 10 mg
Metformin hydrochloride
(Extended release)….1000 mg
(Antidiabetic)
Form 5-D
Diary No. 2741
24-02-2017
PKR.50,000/-
23-02-2017
101. M/s Hilton Pharma
(Pvt) Ltd., Plot 13 &
14, Sector 15, Korangi
Industrial Area,
Karachi
Empa-Met XR 12.5/1000mg
tablet
Each film coated tablet contains:
Empagliflozin …….. 12.5 mg
Metformin hydrochloride
(Extended release)….1000 mg
(Antidiabetic)
Form 5-D
Diary No. 2738
24-02-2017
PKR.50,000/-
23-02-2017
102. M/s Hilton Pharma
(Pvt) Ltd., Plot 13 &
14, Sector 15, Korangi
Industrial Area,
Karachi
Empa-Met XR 25/1000mg tablet
Each film coated tablet contains:
Empagliflozin …….. 25 mg
Metformin hydrochloride
(Extended release)….1000 mg
(Antidiabetic)
Form 5-D
Diary No. 2739
24-02-2017
PKR.50,000/-
23-02-2017
Remarks of Evaluator:
Firm has initially submitted application with brand name Empa-Met XR, later on the firm has
submitted stability studies with brand name Xenglu-Met XR Tablets.
The firm has submitted stability study data along with required documents as per checklist approved in
251st meeting of Registration Board. Detailsof submitted data are as under:
(Dy.# 26176 dated 05-12-2019)
STABILITY STUDY DATA
Manufacturer of API Empagliflozin: Jiangsu Yongan Pharmaceutical Co., Ltd. No. 18, Provincial
Highway 237, Huaian Economic Development Zone, Jiangsu
Metformin hydrochloride: Abhilash Chemicals & Pharmaceuticals (Pvt.)
Ltd., India.
API Lot No. Empagliflozin: 4500-201902001
Metformin: MET/01/18122315
Description of Pack
(Container closure system)
Alu-Alu blister foil with unit carton
Stability Storage Condition Accelerated: 40°C ± 2°C / 75% ± 5%RH
Real Time: 30°C ± 2°C / 65% ± 5%RH
Time Period Accelerated: 6 Months Real Time: 6 Months
Frequency Real Time: 0,3 & 6 (months)
Accelerated: 0,3 & 6 (months)
XENGLUMET XR 5/1000MG TABLET
Batch No. EMP-404109-6 EMP-404209-7 EMP-404309-8
Batch Size 1500 Tablets 1500 Tablets 1500 Tablets
Manufacturing Date 04-2019 04-2019 04-2019
Date of Initiation 24-05-2019 24-05-2019 24-05-2019
XENGLUMET XR 10/1000MG TABLET
Batch No. EMP-404609-2 EMP-404709-3 EMP-404809-4
Batch Size 1500 Tablets 1500 Tablets 1500 Tablets
Minutes of 294th Meeting of Registration Board | 139
Manufacturing Date 04-2019 04-2019 04-2019
Date of Initiation 24-05-2019 24-05-2019 24-05-2019
XENGLUMET XR 12.5/1000MG TABLET
Batch No. EMP-404909-1 EMP-405009-2 EMP-405109-3
Batch Size 1500 Tablets 1500 Tablets 1500 Tablets
Manufacturing Date 04-2019 04-2019 04-2019
Date of Initiation 24-05-2019 24-05-2019 24-05-2019
XENGLUMET XR 25/1000MG TABLET
Batch No. EMP-405209-1 EMP-405309-2 EMP-405409-3
Batch Size 1500 Tablets 1500 Tablets 1500 Tablets
Manufacturing Date 04-2019 04-2019 04-2019
Date of Initiation 24-05-2019 24-05-2019 24-05-2019
No. of Batches 03
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Documents To Be Provided Status
COA of API Yes
Approval of API by regulatory authority of country of
origin or GMP certificate of API manufacturer issued
by regulatory authority of country of origin.
Empagliflozin: Firm has submitted copy of GMP
certificate (No. JS20160548) of M/s Jiangsu Yongan
Pharmaceutical Co. Ltd, issued by CFDA China. The
certificate is valid till 3-3-2021.
Metformin: Firm has submitted copy of GMP certificate
(No. WC-0345) of M/s Abhilash Chemicals issued by
Central Drugs Standard Control Organization,
Government of India. The certificate is valid till 27-09-
2021.
Protocols followed for conduction of stability study and
details of tests. Yes
Data of 03 batches will be supported by attested
respective documents like chromatograms, laboratory
reports, data sheets etc.
Yes
Documents confirming import of API etc. Empagliflozin: Firm has submitted copy of commercial
invoice dated 01-03-2019 specifying import of 60 Kg
Empagliflozin. The invoice has been signed by AD DRAP
Karachi.
Metformin: Firm has submitted copy of commercial
invoice dated 28-12-2018 specifying import of 200 x 50kg
metformin HCl. The invoice is signed by AD DRAP
Karachi.
All provided documents will be attested (name, sign
and stamp) for ensuring authenticity of data /
documents.
Yes
Commitment to continue real time stability study till
assigned shelf life of the product. Yes
Commitment to follow Drug Specification Rules, 1978. Yes
DATA FOR EXEMPTION FROM ONSITE INVESTIGATION OF SUBMITTED STABILITY DATA
Minutes of 294th Meeting of Registration Board | 140
ADMINISTRATIVE PORTION
1. Reference of last onsite panel
inspection for instant dosage
form conducted during last two
years.
Firm has referred to last onsite inspection of their product HILVEL Tablets
(Sofosbuvir / Velpatasvir) which was considered and approved by
Registration Board in its 277th Meeting with following details:
Date of Inspection: 14-12-2017.
The HPLC is 21CFR Compliant.
Audit trail on the testing reports were available.
2. Documents for the procurement
of API with approval from
DRAP (in case of import).
Empagliflozin: Firm has submitted copy of commercial invoice dated 01-
03-2019 specifying import of 60 Kg Empagliflozin. The invoice has been
signed by AD DRAP Karachi.
Metformin: Firm has submitted copy of commercial invoice dated 28-12-
2018 specifying import of 200x50kg metformin HCl. The invoice is signed
by AD DRAP Karachi.
3. Documents for the procurement
of reference standard and
impurity standards.
Firm has submitted copy of invoice of purchase of working reference
standard and impurity.
4. Approval of API/ DML/GMP
certificate of API manufacturer
issued by regulatory authority
of country of origin.
Empagliflozin: Firm has submitted copy of GMP certificate (No.
JS20160548) of M/s Jiangsu Yongan Pharmaceutical Co. Ltd, issued by
CFDA China. The certificate is valid till 3-3-2021.
Metformin: Firm has submitted copy of GMP certificate (No. WC-0345)
of M/s Abhilash Chemicals issued by Central Drugs Standard Control
Organization, Government of India. The certificate is valid till 27-9-2021.
5. Mechanism for Vendor pre-
qualification
Firm has submitted copy of vendor’s audit form and SOPs for selection of
vendor.
6. Certificate of analysis of the
API, reference standards and
impurity standards
Firm has submitted COA of API, and reference standard.
7. Documents for the procurement
of excipients used in product
development?
Firm has submitted documents for procurement of excipients.
8. List of qualified staff involved
in product development with
relevant experience.
Firm has provided list of technical staff of product development section.
PRODUCTION DATA
9. Authorized Protocols/SOP for
the development & stability
testing of trial batches.
Firm has submitted authorized general protocols/SOPs for the development
& testing of trial batches.
10. Complete batch manufacturing
record of three stability batches.
Firm has provided Batch Manufacturing Record for all the batches
11. Record of remaining quantities
of stability batches.
Firm has provided following remaining quantities for each batch:
XENGLUMET XR 5/1000MG TABLET
EMP-404109-6: 133 Tablets
EMP-404209-7: 133 Tablets
EMP-404309-8: 133 Tablets
XENGLUMET XR 10/1000MG TABLET
EMP-404609-2: 130 Tablets
EMP-404709-3: 130 Tablets
EMP-404809-4: 130 Tablets
XENGLUMET XR 12.5/1000MG TABLET
EMP-404909-1: 154 Tablets
Minutes of 294th Meeting of Registration Board | 141
EMP-405009-2: 154 Tablets
EMP-405109-3: 154 Tablets
XENGLUMET XR 25/1000MG TABLET
EMP-405209-1: 156 Tablets
EMP-405309-2: 156 Tablets
EMP-405409-3: 156 Tablets
QA/QC DATA
12. Record of Digital data logger
for temperature and humidity
monitoring of stability
chambers (real time and
accelerated)
Firm has submitted record of Digital data logger for temperature and
humidity monitoring of stability chambers.
13. Method used for analysis of API
along with COA.
Firm has submitted COA and method of analysis of API.
14. Method used for analysis of
FPP & complete record of
testing of stability batches (i.e.
chromatograms, lab reports,
raw data sheets etc.)
Firm has submitted method of analysis of FPP and complete record of
testing of stability batches along with chromatograms
15. Reports of stability studies of
API from manufacturer.
Firm has submitted both accelerated (40°C ± 2°C & 75±5%RH) stability
studies & long term (30°C ± 2°C & 65±5%RH) stability studies reports of
three batches of both API’s.
16. Analysis reports for excipients
used.
Firm has submitted analysis reports for all excipients used.
17. Drug-excipients compatibility
studies.
Firm has submitted that their formulation is as per reference product so they
do not require drug excipient compatibility studies.
18. Record of comparative
dissolution data.
Firm has submitted data of comparative dissolution profile at pH 1.2 buffer,
4.5 buffer, 6.8.phosphate buffer and calculated difference of % release with
innovator product and also calculated f2 factor. The value of f2 factor in all
dissolution medium for all the strengths fall in acceptable range.
19. Compliance Record of HPLC
software 21CFR & audit trail
reports on product testing.
Firm has submitted audit trail reports for HPLC analysis for all the three
batches.
Evaluation by PEC:
Firm has developed the formulation as per the innovator product having extended release inner core of
metformin hydrochloride and outer coating containing immediate release empagliflozin.
Decision: Registration Board decided to approve registration of Empa-Met XR 5/1000mg tablet,
Empa-Met XR 10/1000mg tablet, Empa-Met XR 12.5/1000mg tablet and Empa-Met XR 25/1000mg
tablet with innovator’s specification by M/s Hilton Pharma (Pvt) Ltd., Plot 13 & 14, Sector 15,
Korangi Industrial Area, Karachi. Manufacturer will place first three production batches on long
term stability studies throughout proposed shelf life and on accelerated studies for six months.
Sr.
No.
Name & Address of
Manufacturer /
Applicant
Brand Name
(Proprietary Name +
Dosage Form + Strength),
Composition,
Pharmacological Group,
Finished Product
Specification
Type of Form,
Initial Diary & Date,
Fee (including
differential fee),
Demanded Price / Pack
size
International Availability /
Local Availability
GMP Inspection Report Date &
Remarks
103. The Searle company
Limited F-319 S.I.T.E
Karachi.
Trelaglip 50mg Tablet
Each film coated tablet
contains:
Form 5D
01-02-2017
PKR 50,000/-
Zafatek Tablets (PMDA Japan
Approved)
Last inspection report dated 30-
Minutes of 294th Meeting of Registration Board | 142
Trelagliptin (as
succinate)….50mg
Antidiabetic
(01-02-2017)
DUPLICATE
01-2019 confirms that firm is
operating at a Good level of
GMP compliance.
104. The Searle company
Limited F-319 S.I.T.E
Karachi.
Trelaglip 100mg Tablet
Each film coated tablet
contains:
Trelagliptin (as
succinate)….100mg
Antidiabetic
Form 5D
01-02-2017
PKR 50,000/-
(01-02-2017)
DUPLICATE
Zafatek Tablets (PMDA Japan
Approved)
Last inspection report dated 30-
01-2019 confirms that firm is
operating at a Good level of
GMP compliance.
Evaluation by PEC:
Firm has submitted accelerated and real time stability data of 6 months as per the requirement of
Registration Board.
STABILITY STUDY DATA
Manufacturer of API Ruyuan HEC Pharm Co. Ltd. Xiaba Development zone, Ruyuan County,
Shaoguan city, Guandong province China.
API Lot No. TGLT-201712001
Description of Pack
(Container closure system)
Pale yellowish red color, oval shaped biconvex film coated tablets packed in
Alu-Alu blister (2x10’s) in a carton
Stability Storage Condition Real time : 30°C ± 2°C / 75% ± 5%RH
Accelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real time: 6 months
Accelerated: 6 months
Frequency Accelerated: 0, 3, 6 (Months)
Real Time: 0, 3, 6 (Months)
Trelaglip 50mg Tablet
Batch No. 18PD-116 18PD-128 18PD-130
Batch Size 2500 Tablets 2500 Tablets 2500 Tablets
Manufacturing Date 05-2018 05-2018 05-2018
Date of Initiation 06-2018 03-12-2018 03-12-2018
Trelaglip 100mg Tablet
Batch No. 18PD-174 18PD-180 18PD-181
Batch Size 2500 Tablets 2500 Tablets 2500 Tablets
Manufacturing Date 08-2018 08-2018 08-2018
Date of Initiation 06-2018 03-12-2018 03-12-2018
No. of Batches 03
Date of Submission 19-08-2019
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
# Documents To Be Provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country
of origin or GMP certificate of API manufacturer
issued by regulatory authority of country of origin.
Copy of GMP Certificate for M/s Ruyuan HEC Pharm
Co., Ltd, China issued by Shaoguan Food and Drug
Administration, China is submitted. It is valid till 18-12-
2019.
3. Protocols followed for conduction of stability study
and details of tests. No
Minutes of 294th Meeting of Registration Board | 143
4. Data of 03 batches will be supported by attested
respective documents like chromatograms,
laboratory reports, data sheets etc.
No
5. Documents confirming import of API etc. Firm has submitted copy of Assistant Director (I & E)
DRAP attested invoice confirming import of 1Kg
trelagliptin succinate dated 30-01-2018.
6. All provided documents will be attested (name,
sign and stamp) for ensuring authenticity of data /
documents.
Yes
7. Commitment to continue real time stability study
till assigned shelf life of the product. Yes
8. Commitment to follow Drug Specification Rules,
1978. Yes
REMARKS OF EVALUATOR
Shortcoming Response by the firm
GMP certificate of the API manufacturer issued by
provincial or federal regulatory authority since the
submitted GMP certificate is issued by Shaoguan
Food and Drug Administration which is a district
regulatory authority.
Copy of GMP Certificate for M/s Ruyuan HEC Pharm Co.,
Ltd, China issued by Shaoguan Food and Drug
Administration, China is submitted. It is valid till 12-4-
2021.
Scientific justification for selection of dissolution
specifications i.e. type of apparatus, volume, speed
(rpm), dissolution medium and dissolution time.
Due to un availability of monograph for trelagliptin and
there is no reference for dissolution available at US FDA.
We, selected the dissolution specification of Sitagliptin
from FDA dissolution data base for trelagliptin because
both molecules are of same therapeutic class having same
BCS classification and have similar mechanism of action.
Justify the variation in dissolution results of
individual tablets i.e. 90.11% to 116.71% at first
time point for batch 18PD-116
We have checked dissolution results of the said batch and
the average values are within specified limits.
DATA FOR EXEMPTION FROM ONSITE INVESTIGATION OF SUBMITTED STABILITY DATA
Firm has submitted data for exemption from onsite investigation of submitted stability data as per the guidelines of
293rd meeting of Registration Board.
1. Reference of previous approval of applications
with stability study data of the firm
Firm has referred to last onsite inspection of their product
Tapendol Tablets 50mg, 75mg and 100mg (Tapentadol)
which was considered and approved by Registration
Board in its 289th Meeting with following details:
Date of Inspection: 11-03-2019
2. Certificate of Analysis of API from both API
Manufacturer and Finished Product manufacturer.
Firm has submitted CoA of API from API manufacturer.
Firm has also submitted copy of CoA of the API
generated by FPP manufacturer.
3. Method used for analysis of API from both API
Manufacturer and Finished Product
manufacturer
Firm has submitted method of analysis of API from both
API manufacturer as well as FPP manufacturer.
4. Stability study data of API from API manufacturer Firm has submitted stability study data of 3 batches of
API as per the conditions of zone IV-A.
5. Approval of API/ DML/GMP certificate of API
manufacturer issued by concerned regulatory
authority of country of origin.
Copy of GMP Certificate for M/s Ruyuan HEC Pharm
Co., Ltd, China issued by Shaoguan Food and Drug
Administration, China is submitted. It is valid till 12-4-
2021.
Minutes of 294th Meeting of Registration Board | 144
6. Documents for the procurement of API with
approval from DRAP (in case of import).
Firm has submitted copy of Assistant Director (I & E)
DRAP attested invoice confirming import of 1Kg
trelagliptin succinate dated 30-01-2018.
7. Protocols followed for conduction of stability
study
Firm has submitted protocols for conduction of stability
studies.
8. Method used for analysis of FPP Firm has submitted drug product testing method.
9. Drug-excipients compatibility studies (where
applicable)
Firm has submitted that their formulation is as per
reference product so they do not require drug excipient
compatibility studies.
10. Complete batch manufacturing record of three
stability batches.
Firm has submitted batch manufacturing record of three
batches of both strengths.
11. Record of comparative dissolution data (where
applicable)
Firm has submitted results of CDP of both strengths with
the innovator product. The results of CDP were within
acceptable limits.
12. Data of 03 batches will be supported by attested
respective documents like chromatograms,
Raw data sheets, COA, summary data sheets etc.
Yes submitted by the firm
13. Compliance Record of HPLC software 21CFR &
audit trail reports on product testing.
Firm has submitted record of HPLC including audit trail
reports for testing on the applied product
14. Record of Digital data logger for temperature and
humidity monitoring of stability chambers
(real time and accelerated)
Firm has submitted record of Digital data logger for
temperature and humidity monitoring of stability
chambers.
REMARKS OF EVALUATOR
Scientific justification for selection of dissolution specifications i.e. type of apparatus, volume, speed (rpm),
dissolution medium and dissolution time was provided by the firm in which they have responded that “Due to un
availability of monograph for trelagliptin and there is no reference for dissolution available at US FDA. We, selected
the dissolution specification of Sitagliptin from FDA dissolution data base for trelagliptin because both molecules
are of same therapeutic class having same BCS classification and have similar mechanism of action”
Decision: Deferred for scientific justification of using dissolution specifications of Sitagliptin tablets
for performing dissolution test of trelagliptin tablets.
Deferred cases
Sr.
No.
Name & Address of
Manufacturer /
Applicant
Brand Name
(Proprietary Name +
Dosage Form + Strength),
Composition,
Pharmacological Group,
Finished Product
Specification
Type of Form,
Initial Diary & Date,
Fee (including
differential fee),
Demanded Price /
Pack size
International Availability / Local
Availability
GMP Inspection Report Date
105. Werrick
Pharmaceuticals,
Plot # 216-217, I-
10/3, Industrial Area
Islamabad.
Xetine 10mg Tablet
Each film coated tablet
contains:
Vortioxetine as
hydrobromide…..10mg
Antidepressant
Form 5
Dy No. 41745
07-12-2018
PKR 20,000/-
07-12-2018
TRINTELLIX Tablets
(USFDA Approved)
GMP compliant dated
07/12/17―Good compliance to
GMP
STABILITY STUDY DATA
Drug Xetine 10mg Tablet
Name of Manufacturer M/s Werrick Pharmaceuticals, Plot # 216-217, I-10/3, Industrial Area Islamabad.
Manufacturer of API Lianyungang Jari Pharmaceutical Co. Ltd. # 18, Zhenhua Road, Lianyunguang,
Jiangsu Province China.
Minutes of 294th Meeting of Registration Board | 145
API Lot No. 20180203
Description of Pack
(Container closure system)
Blistered in Alu-PVC packed in card box unit carton of 14’s tablets
Stability Storage Condition Accelerated: 40°C ± 2°C/75%±5% RH
Real Time: 30°C ± 2°C/65%±5% RH
Time Period Accelerated: 6 (months)
Real Time: 6 (months)
Frequency Accelerated: 0, 3 ,6 (Months)
Real Time : 0, 3 ,6 ,9, 12, 18 (Months)
Batch No. T#01 T#02 T#03
Batch Size 1500 Tablets 1500 Tablets 1500 Tablets
Manufacturing Date 08 – 2018 08 – 2018 08 – 2018
Date of Initiation 12-09-2018 12-09-2018 17-10-2018
No. of Batches 03
Date of Submission 15744 (26-08-2019)
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr.# Documents To Be Provided Status
COA of API. Yes
1. Approval of API by regulatory authority of
country of origin or GMP certificate of API
manufacturer issued by regulatory authority of
country of origin.
Firm has submitted copy of GMP certificate No.
JS20140353 issued by China Food and Drug Administration
which is valid till 19-11-2019.
2. Protocols followed for conduction of stability
study and details of tests.
Yes
3. Data of 03 batches will be supported by attested
respective documents like chromatograms,
laboratory reports, data sheets etc.
Yes
4. Documents confirming import of API etc. Firm has submitted copy of commercial invoice dated 15-5-
2018 specifying import of 0.5Kg vortioxetine hydrobromide
attested by AD DRAP, Islamabad.
5. All provided documents will be attested (name,
sign and stamp) for ensuring authenticity of
data / documents.
Yes
6. Commitment to continue real time stability
study till assigned shelf life of the product.
Yes
7. Commitment to follow Drug Specification
Rules, 1978.
Yes
REQUEST OF EXEMPTION FROM ON SITE INSPECTION
The firm has requested for Exemption from On-site Investigation of their submitted stability data and provided the
following documents in conjunction with the checklist approved by the Registration Board in its 278th Meeting:
Administrative Portion
1. Reference of last onsite panel inspection for
instant dosage form conducted during last
two years.
Registration Board approved Cell-Tab (Sofosbuvir 400mg)
Tablets in its 276th Meeting.
Dates of Inspection:
o Initial (M-256):
10th December 2015 (Afternoon).
Minutes of 294th Meeting of Registration Board | 146
o Subsequent (M-269):
19th April, 2017 (Forenoon).
o Last Inspection (M-276):
20th November, 2017.
Following points related to HPLC Software and Audit Trail
were reported
Software of HPLC present in the firm is 21CFR compliant
and audit trail on the testing reports was available and
confirmed. Panel reviewed chromatograms for testing of API
and trial batches at 0, 3 and 6 months for real time and
accelerated stability testing.
2. Documents for the procurement of API with
approval from DRAP (in case of import).
Firm has submitted copy of commercial invoice dated 15-5-
2018 specifying import of 0.5Kg vortioxetine hydrobromide
attested by AD DRAP, Islamabad.
3. Documents for the procurement of reference
standard and impurity standards.
The firm has submitted letter that the reference standard were
provided along with API and therefore separate invoice is not
available.
4. Approval of API/ DML/GMP certificate of
API manufacturer issued by regulatory
authority of country of origin.
Firm has submitted copy of GMP certificate No. JS20140353
issued by China Food and Drug Administration which is valid
till 19-11-2019.
5. Mechanism for Vendor pre-qualification Firm has submitted work instructions for evaluation of
suppliers and vendors
6. Certificate of analysis of the API, reference
standards and impurity standards
Firm has submitted copy of COA of API and reference and
impurity standard.
7. Documents for the procurement of excipients
used in product development?
The firm has submitted documents for procurement of
excipients used in the formulation of applied product.
8. List of qualified staff involved in product
development with relevant experience.
The firm has submitted List of qualified staff involved in R&D
department.
Production Data
9. Authorized Protocols/SOP for the
development & stability testing of trial
batches.
The firm has submitted copy of product development protocols.
10. Complete batch manufacturing record of
three stability batches.
The firm has submitted copy of Batch Manufacturing Records
of all the three Batches.
11. Record of remaining quantities of stability
batches.
Firm has provided following remaining quantities for each
batch:
T#01: 69 Packs
T#02: 71 Packs
T#03: 72 Packs
QA / QC DATA
12. Record of Digital data logger for temperature
and humidity monitoring of stability
chambers (real time and accelerated)
Firm has submitted copies of data logger record for stability
chambers with real time and accelerated stability testing
13. Method used for analysis of API along with
COA.
The firm has submitted copy of Raw Material Specifications,
Raw Material Testing Procedures along with COA.
14. Method used for analysis of FPP & complete
record of testing of stability batches (i.e.
chromatograms, lab reports, raw data sheets
etc.)
The firm has submitted copy of Finished Product Testing
Procedure and specification.
15. Reports of stability studies of API from
manufacturer.
The firm has submitted stability study data of 3 batches of API
as per the conditions of Zone IV-A.
Minutes of 294th Meeting of Registration Board | 147
16. Analysis reports for excipients used. Firm has submitted analysis reports for all excipients used in
applied product development
17. Drug-excipients compatibility studies. Firm has submitted that stability studies are indicative of
chemical and physical compatibility with the drug product.
These studies clearly demonstrate that the excipients used for
manufacture of the dosage form are compatible with the API.
18. Record of comparative dissolution data. Firm has submitted data sheets of comparative dissolution
profile with the innovator brand in which both the reference and
test product show more than 85% release in 15 minutes at pH
1.2 and 4.5pH buffer.
19. Compliance Record of HPLC software
21CFR & audit trail reports on product
testing.
Audit trail on testing reports for the applied product has been
submitted by the firm.
Remarks of the evaluator:
Shortcomings communicated Response by the firm
Justify the acceptance criteria of dissolution test
NLT 85% after 45 minutes since USFDA
chemistry review for the innovator product
“Trintellix Tablet” specifies that the acceptance
criteria for dissolution test is NLT (Q+5) in 30
minutes.
USFDA reference (updated on 28-5-2015) for the
acceptance criteria of dissolution test NLT Q+5 after 45
minutes is attached.
Firm has referred to the recommended sampling times
mentioned in FDA dissolution methods database in which
time point 10, 15, 20, 30 and 45 minutes is mentioned. As
per the stance of the firm since the last time point is 45
minutes that’s why they have adopted the same as
dissolution acceptance criteria.
As per the Dissolution Methods Database Frequently
Asked Questions, The "Recommended Sampling Times"
field specifies the times recommended for taking
dissolution samples for a particular drug product to
generate a dissolution profile.
Justify why similarity factor f2 is not calculated at
phosphate buffer pH 6.8 since more than 85% drug
is not released at 15 minutes time point.
Firm has now submitted f2 values which are more than 50.
Justify the difference in release behaviour of
proportionately equal strengths of the innovator
product in acetate buffer pH 4.5 and phosphate
buffer pH 6.8. The average release of 10mg
strength at acetate buffer pH 4.5 at 15 minutes time
interval is 91.9%, while the same for 20mg strength
is 76%. Similarly the release of 20mg tablet is
significantly lower at phosphate buffer pH 6.8 as
compared to 10mg strength as per the details
provided in the table below.
The difference in release behaviour of proportionately
equal strengths depends on the solubility of vortioxetine
(API) in different pH. The solubility decreases with
increase in pH of medium. Due to decrease in solubility
and saturation of drug in the medium, the %age release of
10mg tablet is higher than the 20mg tablets i.e. increasing
the drug concentration in low soluble medium will
decrease the %age of dissolved drug.
Further justify how the drug release at a later time
point i.e. 30 min or the 45 min can be less than the
drug release at earlier time point i.e. 15 min. For
example the drug release of 10mg tablet in acetate
buffer pH 4.5 at 15 min time point is 92.97% and
the drug release at 30min time point in the same
medium is 85.01%.
The drug release in question of innovator product and is on
as is basis, hence we cannot comment on the release
behaviour of innovator product. However the release
behaviour of our applied product “Xetine Tablets” does not
show such behaviour.
The exact results of comparative dissolution profile are
attached in Table 3 below. As per the results both Brintellix
as well as Xetine Tablets have the same issue as
highlighted in bold or italic in Table 3. The dissolution
testing as well as CDP is performed through UV method.
Any document for validation of the UV method is not
submitted, documents for validation of HPLC method for
Minutes of 294th Meeting of Registration Board | 148
assay has been submitted along with testing method of
finished product.
Table 1
Sr. No Acetate buffer pH 4.5
10mg Tablet 20mg Tablet
15 min 30 min 45 min 15 min 30 min 45 min
1 94.34 92.46 91.69 76.38 73.51 82.14
2 86.81 92.46 91.43 75.42 77.66 85.33
3 92.97 85.01 86.81 74.47 82.14 85.97
4 94.26 87.84 93.49 75.10 86.29 85.65
5 91.69 88.86 90.66 76.70 75.42 83.73
6 88.35 91.43 92.46 77.98 76.06 82.46
Avg 91.90 89.68 91.09 76.00 78.51 84.21
Table 2
Sr. No Phosphate buffer pH 6.8
10mg Tablet 20mg Tablet
15 min 30 min 45 min 15 min 30 min 45 min
1 68.06 68.87 77.79 27.42 27.07 45.92
2 64.28 73.73 83.46 25.70 32.21 45.24
3 67.25 72.92 76.98 33.24 34.61 50.72
4 66.98 72.65 82.11 32.21 30.16 40.44
5 63.74 79.41 78.06 27.42 38.38 41.13
6 69.95 82.92 74.00 31.53 29.82 45.58
Avg 66.71 75.08 78.73 29.58 32.04 44.58
Table 3
Sr. No 0.1N HCl
15 min (%) 30 min (%) 45 min(%)
Brintellix Xetine Brintellix Xetine Brintellix Xetine
1 98.67 96.73 99.15 96.73 99.40 96.98
2 98.91 96.25 98.67 96.01 99.15 97.46
3 98.19 95.77 99.64 96.49 98.43 96.01
4 98.91 95.53 98.67 97.46 99.64 98.19
5 97.94 96.25 99.40 96.73 98.67 96.73
6 99.64 97.22 98.43 96.25 99.15 97.46
Avg 98.71 96.29 98.99 96.61 99.07 97.14
Sr. No Acetate buffer pH 4.5
15 min (%) 30 min (%) 45 min(%)
Brintellix Xetine Brintellix Xetine Brintellix Xetine
1 97.34 89.63 92.46 88.86 91.69 88.35
2 86.81 87.07 92.46 87.84 91.43 89.38
3 92.97 85.01 85.01 89.38 86.81 88.09
4 94.26 87.07 87.84 87.58 93.49 89.12
5 91.69 89.38 88.86 88.61 90.66 88.86
6 88.35 88.61 91.43 89.38 92.46 88.61
Avg 91.90 87.80 89.68 88.61 91.09 88.74
Sr. No Phosphate buffer pH 6.8
15 min (%) 30 min (%) 45 min(%)
Brintellix Xetine Brintellix Xetine Brintellix Xetine
1 68.06 65.09 68.87 74.27 77.79 75.63
2 64.28 64.28 73.73 73.46 83.46 76.71
3 67.25 65.36 72.92 72.65 76.98 77.25
4 66.98 63.20 72.65 73.73 82.11 76.44
Minutes of 294th Meeting of Registration Board | 149
5 63.74 64.28 79.41 73.19 78.06 75.36
6 69.95 64.55 82.92 74.0 74.0 76.98
Avg 66.71 64.46 75.08 73.55 78.73 76.40
Decision of 293rd meeting of Registration Board:
Registration Board decided to consider the case after onsite inspection for verification of authenticity of submitted
data for comparative dissolution profile due to reason recorded above.
Sr.
No.
Name & Address of
Manufacturer /
Applicant
Brand Name
(Proprietary Name +
Dosage Form + Strength),
Composition,
Pharmacological Group,
Finished Product
Specification
Type of Form,
Initial Diary & Date,
Fee (including
differential fee),
Demanded Price / Pack
size
International Availability /
Local Availability
GMP Inspection Report Date
106. Werrick
Pharmaceuticals,
Plot # 216-217, I-
10/3, Industrial Area
Islamabad.
Xetine 20mg Tablet
Each film coated tablet
contains:
Vortioxetine as
hydrobromide…..20mg
Antidepressant
Form 5
Dy No. 41746
07-12-2018
PKR 20,000/-
07-12-2018
TRINTELLIX Tablets
(USFDA Approved)
GMP compliant dated
07/12/17―Good compliance
to GMP
STABILITY STUDY DATA
Drug Xetine 20mg Tablet
Name of Manufacturer M/s Werrick Pharmaceuticals, Plot # 216-217, I-10/3, Industrial Area Islamabad.
Manufacturer of API Lianyungang Jari Pharmaceutical Co. Ltd. # 18, Zhenhua Road, Lianyunguang,
Jiangsu Province China.
API Lot No. 20180203
Description of Pack
(Container closure system)
Blistered in Alu-PVC packed in card box unit carton of 14’s tablets
Stability Storage Condition Accelerated: 40°C ± 2°C/75%±5% RH
Real Time: 30°C ± 2°C/65%±5% RH
Time Period Accelerated: 6 (months)
Real Time: 6 (months)
Frequency Accelerated: 0, 3 ,6 (Months)
Real Time : 0, 3 ,6 ,9, 12, 18 (Months)
Batch No. T#01 T#02 T#03
Batch Size 1500 Tablets 1500 Tablets 1500 Tablets
Manufacturing Date 08 – 2018 09 – 2018 09 – 2018
Date of Initiation 28-09-2018 28-09-2018 28-9-2018
No. of Batches 03
Date of Submission 15743 (26-08-2019)
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr.# Documents To Be Provided Status
COA of API. Yes
1. Approval of API by regulatory authority of
country of origin or GMP certificate of API
manufacturer issued by regulatory authority of
country of origin.
Firm has submitted copy of GMP certificate No.
JS20140353 issued by China Food and Drug
Administration which is valid till 19-11-2019.
Minutes of 294th Meeting of Registration Board | 150
2. Protocols followed for conduction of stability
study and details of tests.
Yes
3. Data of 03 batches will be supported by
attested respective documents like
chromatograms, laboratory reports, data sheets
etc.
Yes
4. Documents confirming import of API etc. Firm has submitted copy of commercial invoice dated 15-
5-2018 specifying import of 0.5Kg vortioxetine
hydrobromide attested by AD DRAP, Islamabad.
5. All provided documents will be attested (name,
sign and stamp) for ensuring authenticity of
data / documents.
Yes
6. Commitment to continue real time stability
study till assigned shelf life of the product.
Yes
7. Commitment to follow Drug Specification
Rules, 1978.
Yes
REQUEST OF EXEMPTION FROM ON SITE INSPECTION
The firm has requested for Exemption from On-site Investigation of their submitted stability data and provided
the following documents in conjunction with the checklist approved by the Registration Board in its 278th
Meeting:
Administrative Portion
1. Reference of last onsite panel inspection for
instant dosage form conducted during last
two years.
Registration Board approved Cell-Tab (Sofosbuvir
400mg) Tablets in its 276th Meeting.
Dates of Inspection:
o Initial (M-256):
10th December 2015 (Afternoon).
o Subsequent (M-269):
19th April, 2017 (Forenoon).
o Last Inspection (M-276):
20th November, 2017.
Following points related to HPLC Software and Audit Trail
were reported
Software of HPLC present in the firm is 21CFR compliant
and audit trail on the testing reports was available and
confirmed. Panel reviewed chromatograms for testing of
API and trial batches at 0, 3 and 6 months for real time and
accelerated stability testing.
2. Documents for the procurement of API with
approval from DRAP (in case of import).
Firm has submitted copy of commercial invoice dated 15-5-
2018 specifying import of 0.5Kg vortioxetine hydrobromide
attested by AD DRAP, Islamabad.
3. Documents for the procurement of reference
standard and impurity standards.
The firm has submitted letter that the reference standard were
provided along with API and therefore separate invoice is not
available.
4. Approval of API/ DML/GMP certificate of
API manufacturer issued by regulatory
authority of country of origin.
Firm has submitted copy of GMP certificate No. JS20140353
issued by China Food and Drug Administration which is valid
till 19-11-2019.
5. Mechanism for Vendor pre-qualification Firm has submitted work instructions for evaluation of
suppliers and vendors
6. Certificate of analysis of the API, reference
standards and impurity standards
Firm has submitted copy of COA of API and reference and
impurity standard.
Minutes of 294th Meeting of Registration Board | 151
7. Documents for the procurement of excipients
used in product development?
The firm has submitted documents for procurement of
excipients used in the formulation of applied product.
8. List of qualified staff involved in product
development with relevant experience.
The firm has submitted List of qualified staff involved in
R&D department.
Production Data
9. Authorized Protocols/SOP for the
development & stability testing of trial
batches.
The firm has submitted copy of product development
protocols.
10. Complete batch manufacturing record of
three stability batches.
The firm has submitted copy of Batch Manufacturing
Records of all the three Batches.
11. Record of remaining quantities of stability
batches.
Firm has provided following remaining quantities for each
batch:
T#01: 69 Packs
T#02: 71 Packs
T#03: 72 Packs
QA / QC DATA
12. Record of Digital data logger for temperature
and humidity monitoring of stability
chambers (real time and accelerated)
Firm has submitted copies of data logger record for stability
chambers with real time and accelerated stability testing
Method used for analysis of API along with
COA.
The firm has submitted copy of Raw Material Specifications,
Raw Material Testing Procedures along with COA.
13. Method used for analysis of FPP & complete
record of testing of stability batches (i.e.
chromatograms, lab reports, raw data sheets
etc.)
The firm has submitted copy of Finished Product Testing
Procedure and specification.
14. Reports of stability studies of API from
manufacturer.
The firm has submitted stability study data of 3 batches of
API as per the conditions of Zone IV-A.
15. Analysis reports for excipients used. Firm has submitted analysis reports for all excipients used in
applied product development
16. Drug-excipients compatibility studies. Firm has submitted that stability studies are indicative of
chemical and physical compatibility with the drug product.
These studies clearly demonstrate that the excipients used for
the manufacture of the dosage form are compatible with the
API.
17. Record of comparative dissolution data. Firm has submitted data sheets of comparative dissolution
profile with the innovator brand
18. Compliance Record of HPLC software
21CFR & audit trail reports on product
testing.
Audit trail on testing reports for the applied product has been
submitted by the firm.
Remarks of the evaluator:
Shortcomings communicated Response by the firm
Justify the acceptance criteria of dissolution test
NLT 85% after 45 minutes since USFDA
chemistry review for the innovator product
“Trintellix Tablet” specifies that the acceptance
criteria for dissolution test is NLT (Q+5) in 30
minutes.
USFDA reference (updated on 28-5-2015) for the
acceptance criteria of dissolution test NLT Q+5 after 45
minutes is attached.
Firm has referred to the recommended sampling times
mentioned in FDA dissolution methods database in which
time point 10, 15, 20, 30 and 45 minutes is mentioned. As
per the stance of the firm since the last time point is 45
minutes that’s why they have adopted the same as
dissolution acceptance criteria.
Minutes of 294th Meeting of Registration Board | 152
As per the Dissolution Methods Database Frequently
Asked Questions, The "Recommended Sampling Times"
field specifies the times recommended for taking
dissolution samples for a particular drug product to
generate a dissolution profile.
Justify why similarity factor f2 is not calculated at
phosphate buffer pH 6.8 since more than 85% drug
is not released at 15 minutes time point.
Firm has now submitted f2 values which are more than 50.
Justify the difference in release behaviour of
proportionately equal strengths of the innovator
product in acetate buffer pH 4.5 and phosphate
buffer pH 6.8. The average release of 10mg
strength at acetate buffer pH 4.5 at 15 minutes time
interval is 91.9%, while the same for 20mg
strength is 76%. Similarly the release of 20mg
tablet is significantly lower at phosphate buffer pH
6.8 as compared to 10mg strength as per the details
provided in the table below.
The difference in release behaviour of proportionately
equal strengths depends on the solubility of vortioxetine
(API) in different pH. The solubility decreases with
increase in pH of medium. Due to decrease in solubility
and saturation of drug in the medium, the %age release of
10mg tablet is higher than the 20mg tablets i.e. increasing
the drug concentration in low soluble medium will
decrease the %age of dissolved drug.
Further justify how the drug release at a later time
point i.e. 30 min or the 45 min can be less than the
drug release at earlier time point i.e. 15 min. For
example the drug release of 10mg tablet at acetate
buffer pH 4.5 at 15 min time point is 92.97% and
the drug release at 30min time point at the same
medium is 85.01%.
The drug release in question of innovator product and is
on as is basis, hence we cannot comment on the release
behaviour of innovator product. However the release
behaviour of our applied product “Xetine Tablets” does
not show such behaviour.
The exact results of comparative dissolution profile are
attached in Table 3 below. As per the results both
Brintellix as well as Xetine Tablets have the same issue as
highlighted in bold or italic in Table 3. The dissolution
testing as well as CDP is performed through UV method.
Any document for validation of the UV method is not
submitted, documents for validation of HPLC method for
assay has been submitted along with testing method of
finished product.
Table 1
Sr. No Acetate buffer pH 4.5
10mg Tablet 20mg Tablet
15 min 30 min 45 min 15 min 30 min 45 min
1 94.34 92.46 91.69 76.38 73.51 82.14
2 86.81 92.46 91.43 75.42 77.66 85.33
3 92.97 85.01 86.81 74.47 82.14 85.97
4 94.26 87.84 93.49 75.10 86.29 85.65
5 91.69 88.86 90.66 76.70 75.42 83.73
6 88.35 91.43 92.46 77.98 76.06 82.46
Avg 91.90 89.68 91.09 76.00 78.51 84.21
Table 2
Sr. No Phosphate buffer pH 6.8
10mg Tablet 20mg Tablet
15 min 30 min 45 min 15 min 30 min 45 min
1 68.06 68.87 77.79 27.42 27.07 45.92
2 64.28 73.73 83.46 25.70 32.21 45.24
3 67.25 72.92 76.98 33.24 34.61 50.72
4 66.98 72.65 82.11 32.21 30.16 40.44
5 63.74 79.41 78.06 27.42 38.38 41.13
6 69.95 82.92 74.00 31.53 29.82 45.58
Avg 66.71 75.08 78.73 29.58 32.04 44.58
Minutes of 294th Meeting of Registration Board | 153
Table 3
Sr. No 0.1N HCl
15 min (%) 30 min (%) 45 min(%)
Brintellix Xetine Brintellix Xetine Brintellix Xetine
1 97.24 96.01 96.32 96.32 101.24 98.16
2 105.55 95.09 99.40 97.24 100.32 96.63
3 103.70 95.70 102.16 96.63 100.63 95.70
4 94.47 96.32 102.47 99.09 103.40 97.86
5 96.32 97.86 104.01 99.40 102.78 100.01
6 95.39 98.16 97.86 95.09 103.40 99.70
Avg 98.77 96.52 100.38 97.29 101.96 98.01
Sr. No Acetate buffer pH 4.5
15 min (%) 30 min (%) 45 min(%)
Brintellix Xetine Brintellix Xetine Brintellix Xetine
1 76.38 75.74 73.51 74.47 82.14 79.90
2 75.42 72.55 77.66 76.38 85.33 81.18
3 74.47 70.63 82.14 77.02 85.97 82.78
4 75.10 74.47 86.29 77.34 85.65 84.37
5 76.70 73.83 75.42 80.86 83.73 83.73
6 77.98 77.66 76.06 76.06 82.46 82.14
Avg 76.00 74.14 78.51 77.02 84.21 82.35
Sr. No Phosphate buffer pH 6.8
15 min (%) 30 min (%) 45 min(%)
Brintellix Xetine Brintellix Xetine Brintellix Xetine
1 27.42 33.24 27.07 31.82 45.92 43.53
2 25.70 25.70 32.21 28.79 45.24 42.15
3 33.24 24.67 34.61 26.73 50.72 45.92
4 32.21 27.07 30.16 29.13 40.44 38.04
5 27.42 26.04 38.38 30.50 41.13 39.09
6 31.53 26.73 29.82 25.36 45.58 36.67
Avg 29.58 27.24 32.04 28.63 44.58 40.89
Decision of 293rd meeting of Registration Board:
Registration Board decided to consider the case after onsite inspection for verification of authenticity of submitted
data for comparative dissolution profile due to reason recorded above
Report on investigation of authenticity / genuineness of CDP data submitted for registration of Xetine
Tablets 10 & 20mg by M/s Werrick Pharmaceuticals, Plot # 216-217, I-10/3, Industrial Area Islamabad.
Reference No: No. F.1-2/2020-PEC dated 18th February, 2020.
Investigation Date & Time: 3rd March, 2020
Investigation Site: Factory premises of Werrick Pharmaceuticals, Plot # 216-217, I-10/3, Industrial
Area Islamabad.
Background: Registration Board in its 293rd meeting considered the case of Xetine (Vortioxetine) Tablet 10mg & 20mg
of M/s Werrick Pharmaceuticals, Plot # 216-217, I-10/3, Industrial Area Islamabad. Registration Board decided
to consider the case after onsite inspection for verification of authenticity of submitted data for comparative
dissolution profile due to the reasons mentioned in the minutes. Chairman Registration Board has constituted the
following panel for the purpose.
Composition of Panel:
1. Mr. Muhammad Haseeb Tariq, Assistant Director PEC, PE&R Division DRAP, Islamabad.
2. Mr. Hanif Ullah, Assistant Director PEC, PE&R Division DRAP, Islamabad.
Scope of Investigation:
Minutes of 294th Meeting of Registration Board | 154
Investigation of the authenticity / genuineness of submitted data for comparative dissolution profile due to the
reasons mentioned in the minutes.
The observations made by Registration Board for Xetine 10mg & 20mg Tablet were
Justify the difference in release behaviour of proportionately equal strengths of the innovator product in
acetate buffer pH 4.5 and phosphate buffer pH 6.8. The average release of 10mg strength at acetate buffer
pH 4.5 at 15 minutes time interval is 91.9%, while the same for 20mg strength is 76%. Similarly the
release of 20mg tablet is significantly lower at phosphate buffer pH 6.8 as compared to 10mg strength as
per the details provided in the table-1 &2 below.
Table 1
Sr. No Acetate buffer pH 4.5
10mg Tablet 20mg Tablet
15 min 30 min 45 min 15 min 30 min 45 min
1 94.34 92.46 91.69 76.38 73.51 82.14
2 86.81 92.46 91.43 75.42 77.66 85.33
3 92.97 85.01 86.81 74.47 82.14 85.97
4 94.26 87.84 93.49 75.10 86.29 85.65
5 91.69 88.86 90.66 76.70 75.42 83.73
6 88.35 91.43 92.46 77.98 76.06 82.46
Avg 91.90 89.68 91.09 76.00 78.51 84.21
Table 2
Sr. No Phosphate buffer pH 6.8
10mg Tablet 20mg Tablet
15 min 30 min 45 min 15 min 30 min 45 min
1 68.06 68.87 77.79 27.42 27.07 45.92
2 64.28 73.73 83.46 25.70 32.21 45.24
3 67.25 72.92 76.98 33.24 34.61 50.72
4 66.98 72.65 82.11 32.21 30.16 40.44
5 63.74 79.41 78.06 27.42 38.38 41.13
6 69.95 82.92 74.00 31.53 29.82 45.58
Avg 66.71 75.08 78.73 29.58 32.04 44.58
Further justify how the drug release at a later time point i.e. 30 min or the 45 min can be less than the
drug release at earlier time point i.e. 15 min. For example the drug release of 10mg tablet at acetate buffer
pH 4.5 at 15 min time point is 92.97% and the drug release at 30min time point at the same medium is
85.01%. (Table 3)
Table 3
Sr. No 0.1N HCl
15 min (%) 30 min (%) 45 min(%)
Brintellix Xetine Brintellix Xetine Brintellix Xetine
1 98.67 96.73 99.15 96.73 99.40 96.98
2 98.91 96.25 98.67 96.01 99.15 97.46
3 98.19 95.77 99.64 96.49 98.43 96.01
4 98.91 95.53 98.67 97.46 99.64 98.19
5 97.94 96.25 99.40 96.73 98.67 96.73
6 99.64 97.22 98.43 96.25 99.15 97.46
Avg 98.71 96.29 98.99 96.61 99.07 97.14
Sr. No Acetate buffer pH 4.5
15 min (%) 30 min (%) 45 min(%)
Brintellix Xetine Brintellix Xetine Brintellix Xetine
1 97.34 89.63 92.46 88.86 91.69 88.35
2 86.81 87.07 92.46 87.84 91.43 89.38
3 92.97 85.01 85.01 89.38 86.81 88.09
4 94.26 87.07 87.84 87.58 93.49 89.12
Minutes of 294th Meeting of Registration Board | 155
5 91.69 89.38 88.86 88.61 90.66 88.86
6 88.35 88.61 91.43 89.38 92.46 88.61
Avg 91.90 87.80 89.68 88.61 91.09 88.74
Sr. No Phosphate buffer pH 6.8
15 min (%) 30 min (%) 45 min(%)
Brintellix Xetine Brintellix Xetine Brintellix Xetine
1 68.06 65.09 68.87 74.27 77.79 75.63
2 64.28 64.28 73.73 73.46 83.46 76.71
3 67.25 65.36 72.92 72.65 76.98 77.25
4 66.98 63.20 72.65 73.73 82.11 76.44
5 63.74 64.28 79.41 73.19 78.06 75.36
6 69.95 64.55 82.92 74.0 74.0 76.98
Avg 66.71 64.46 75.08 73.55 78.73 76.40
Detail of investigation for Xetine Tablets 10mg & 20mg:
Based on the records available with the firm and after detailed discussion with the qualified person and the analyst
who performed comparative dissolution profile testing, the panel observed the following important points:
1. Authenticity of the performance of comparative dissolution profile was confirmed through log book of
the dissolution apparatus, availability of the innovator pack against which the testing was performed.
However, relevant entries in UV spectrophotometer log book were not found. The firm informed that
during product development and stability studies, they usually maintain a single log book for dissolution
apparatus. However the panel advised the firm to maintain separate log book for UV along with
dissolution apparatus. The firm agreed to the advice of panel and shown firm commitment to maintain
separate log book for UV apparatus.
2. The deviation observed in trends of comparative dissolution profile was also noted by the firm during
stability studies and reported the exact results.
3. Previously, the firm performed comparative dissolution profile using UV analytical method. After the
observations raised by the Registration Board, the firm validated their UV analytical method on 19
February, 2020. In addition, the firm also developed HPLC method and performed comparative
dissolution profile using HPLC method, which did not show those deviations as observed with UV
spectrophotometric method.
The above observations of the panel are forwarded for consideration by the Registration Board.
Decision: Registration Board decided to approve registration of Xetine Tablets 10mg and Xetine
Tablets 20mg with innovator’s specification. Manufacturer shall place first three production
batches on long term stability studies throughout proposed shelf life and on accelerated studies
for six months. The Board further decided that the firm shall use HPLC method for dissolution
testing of their production batches.
Minutes of 294th Meeting of Registration Board | 156
Item No. 5: Agenda of Evaluator PEC-IV.
Case no. 01 Registration applications of drugs for which stability study data is submitted
Sr.
No.
Name & Address
of Manufacturer
/ Applicant
Brand Name
(Proprietary Name + Dosage Form +
Strength), Composition,
Pharmacological Group,
Finished Product Specification
Type of Form,
Initial Diary & Date, Fee
(including differential
fee),
Demanded Price / Pack
size
International
Availability / Local
Availability
GMP Inspection Report
Date & Remarks
107. Neutro pharma
(Pvt.) Ltd. 9.5
km Sheikhupura
Road
Lahore
Nupreced Injection
Each 2ml contains:-
Dexmedetomidine
Hydrochloride…………….200mcg
(Sedative)
e alpha2-adrenergic agonist
Manufacturer specifications
Form 5-D
Dy.No.17-05-13
Fee Rs.60,000/-+
Rs.90,000 (28-05-13)
2ml
Rs.5500/-per
ampoule
Precedex of USFDA
approved
REMARKS OF EVALUATOR
Previous Decision (M-239):
Deferred for confirmation of availability of formulation in FDA, EMA,Australia and Japan (M-239)
Previous Decision (M-241): The request of firm was deferred for opinion of following experts.
Head. Department of ICU, MH, Rawalpindi.
Head. Department of Anesthesia, PIMS, Islamabad.
Brig. Dr.Muhammad Aslam khan
Previous Decision (M-249): The firm has the submitted that the third expert nominated by the Board is Head of
Department of ICU,Rawalpindi , is also Brig. Dr. Muhammad Aslam Khan who has already provided expert
opinion and both the experts has commented as under:-
Name of expert. Comments
Prof. M. Iqbal Memon
1. Said drug is already in practice worldwide and few centers in
Pakistan.
2. On page 14 there is typographical mistake showing that said
firm not checked before submission on serial No. 1. It is not
Lidocaine but Dexmedatomidine HCl as active ingredient.
Calculation from gram to microgram may be revisited
according to their statement of manufacturing step (25L to 206
litres).
3. Said firm has not mentioned about the country of import for
raw material and how quality of that material will be
maintained during transport to Pakistan.
4. Are they going to check the efficacy drug in animal lab?
Brig. Dr.Muhammad
Aslam khan
Dexmedetomidine is a highly selective, centrally acting alpha-
2-agonist with anxiolytic, sedative, and some analgesic effects. It has
no deleterious effects on respiratory drive. According to the approved
product information from the United States Food and Drug
Administration (FDA), dexmedetomidine is indicated for initial
sedation of mechanically ventilated patients for up to 24 hours.
Its indications include sedation of initially-intubated and
medicinally-ventilated patients during treatment in an intensive care
setting. Procedural sedation prior to and/ or during awake fiber optic
intubation; sedation prior to and/ or during surgical or other
procedures of nonintubated patients.
Dexmedetomidine may be less likely to cause delirium, than
sedative agents in the ICU. It will be a useful addition in the
Minutes of 294th Meeting of Registration Board | 157
armamentarium of the intensivist unit and anesthetists.
In view of the above I recommend this drug for registration at
an affordable price
Registration Board discussed and agreed to above expert opinions.
However, the Board advised firm to submit laboratory scale scientifically rational stability
data for above registration application. (M-249)
STABILITY STUDY DATA
Drug Nupreced Injection
Name of Manufacturer Neutro pharma (Pvt.) Ltd. 9.5 km Sheikhupura Road
Lahore
Manufacturer of API Cisen pharmaceuticals Co Ltd, China
API Lot No. 170802
Description of Pack
(Container closure system)
USP Type I glass Ampoule
Stability Storage Condition Real time : 30°C ± 2°C / 75% ± 5% RH
Accelerated: 40°C ± 2°C / 75% ± 5% RH
Time Period Real time: 6 months Accelerated: 6 months
Frequency Accelerated: 0, 1, 2 , 3, 4 ,6 (month) Real Time: 0,3 ,6, 9 (month)
Batch No. 001 002 003
Batch Size 2 Liter 2 Liter 2 Liter
Manufacturing Date 02-2018 03-2018 03-2018
Date of Initiation 23-02- 2018 02-03- 2018 02-03- 2018
No. of Batches 3
Date of Submission 20-03-2019 (Dy. No. 1312)
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr. Documents To Be Provided Status
1. COA of API Copy of COA by Cisen pharmaceuticals Co Ltd,
China is submitted.
2. Approval of API by regulatory authority of country of
origin or GMP certificate of API manufacturer issued by
regulatory authority of country of origin.
Copy of GMP Certificate No. SD20130130 by
China Food and Drug Adminstration valid till 04-
11-2018
3. Protocols followed for conduction of stability study and
details of tests.
Yes
4. Data of 03 batches will be supported by attested
respective documents like chromatograms, laboratory
reports, data sheets etc.
Yes
5. Documents confirming import of API etc.
6. All provided documents will be attested (name, sign and
stamp) for ensuring authenticity of data / documents.
Yes
7. Commitment to continue real time stability study till
assigned shelf life of the product.
Yes
8. Commitment to follow Drug Specification Rules, 1978. Yes
REMARKS OF EVALUATOR
Minutes of 294th Meeting of Registration Board | 158
S.NO Shortcomings Reply Evaluation
1) Valid GMP of API source is still not
submitted.
We have already submitted GMP
certificate. This certificate is valid
when we have submitted
application, now the said company
is merge in another company so we
are unable to submit new GMP
certificate because they refused to
give us also refused to give any
merging letter
Issue date 05-11-2013
Valid date 04-11-2018
Cisen pharmaceuticals
Co Ltd, China
2) You have claimed that you have
imported API via FedEx and did not
get Assistant Director (I & E) DRAP
attestation of imported API, while
Reference standard has been imported
& Assistant Director (I & E) DRAP
attested invoice has been submitted.
Justify and clarify.
We have import API through
FedEx in Nov. 2017 while
reference standard received in
December 2018 and get its
approval which unfortunately
attached, we have used working
standard prepared by analysis
through non aqua titration method
given by API manufacturer, which
is attached for as a reference.
On Website that tracking
No, can not be found.
3) As per submitted Assistant Director (I
& E) DRAP attested Commercial
invoices, the reference standard have
been imported in December 2018,
while the submitted record shows the
manufacturing of trial batches in
February & march , 2018. Justification
shall be submitted in this regard.
4) In previous stability sheets Batch No#
004 , Batch No# 005, Batch No# 006
mentioned and in reply in stability
sheets Batch No# 001, Batch No# 002
and Batch No# 003 mentioned. Please
clarify.
The Actual batches were 001, 002,
and 003 but by mistake batch no
04, 05 and o6 were written in the
previous data so, we have rectified
that in the submitted data.
In raw data sheets
batches were 001, 002,
and 003 while previously
certificate of analysis
mentioned batch no 004,
005 and 006.
Decision: Deferred for submission of submission of valid GMP certificate of API manufacturer issued by
regulatory authority of country of origin.
Sr.
No.
Name & Address of
Manufacturer /
Applicant
Brand Name
(Proprietary Name +
Dosage Form + Strength),
Composition,
Pharmacological Group,
Finished Product
Specification
Type of Form,
Initial Diary &
Date, Fee
(including
differential fee),
Demanded Price
/ Pack size
International Availability
/ Local Availability
GMP Inspection Report
Date & Remarks
108. M/s. Vision
Pharmaceuticals , Plot #
22-23, Industrial
Triangle, Kahuta road,
Islamabad
K-Fast 50mg Sachet
Each Sachet contains:-
Diclofenac Potassium
………..50mg
NSAID
Manufacturer’s specification
Dy.No.2695;
21-01-2019;
Rs.50,000/-
21-01-2019
30’s
As per SRO
CAMBIA
(USFDA) approved
Last inspection conducted
on 26-01-2018 and report
concludes that firm was
operating at Good level of
GMP compliance.
STABILITY STUDY DATA
Drug K-Fast 50mg Sachet
Name of Manufacturer M/s. Vision Pharmaceuticals , Plot # 22-23, Industrial Triangle, Kahuta
road, Islamabad
Minutes of 294th Meeting of Registration Board | 159
Manufacturer of API Huixian Dongpu Chemicals co Ltd , China
API Lot No. 20170520
Description of Pack
(Container closure system)
Paper coated aluminium sachet
Stability Storage Condition Real time : 30°C ± 2°C / 65% ± 5% RH
Accelerated: 40°C ± 2°C / 75% ± 5% RH
Time Period Real time: 6 months
Accelerated: 6 months
Frequency Accelerated: 0, 3,6 (month)
Real Time: 0,1,2 3,4,5,6 (month)
Batch No. NPD801(T-01) NPD801(T-02) NPD801(T-03)
Batch Size 1000 Sachet 1000 Sachet 1000 Sachet
Manufacturing Date 16-05-2018 17-05-2018 21-05-2018
Date of Initiation 23-05- 2018 24-05- 2018 25-05- 2018
No. of Batches 3
Date of Submission 21-01-2019 (Dy. No. 2695)
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr. Documents To Be Provided Status
1. COA of API Copy of COA Shanghai Pharma group Changzhou kony
Pharmaceuticals co., Ltd is submitted
2. Approval of API by regulatory authority of
country of origin or GMP certificate of API
manufacturer issued by regulatory authority of
country of origin.
Copy of GMP Certificate No.HN20160178 issued by
Cfda is attached but could not verified from CFDA
database
3. Protocols followed for conduction of stability
study and details of tests.
Yes
4. Data of 03 batches will be supported by
attested respective documents like
chromatograms, laboratory reports, data
sheets etc.
Yes
5. Documents confirming import of API etc. Copy of Assistant Director (I & E) DRAP (Karachi)
attested dated: 21-06-2018 Commercial Invoice No
WIS180048 Dated:05-06-2018 is submitted.
6. All provided documents will be attested
(name, sign and stamp) for ensuring
authenticity of data / documents.
Yes
7. Commitment to continue real time stability
study till assigned shelf life of the product.
Yes
8. Commitment to follow Drug Specification
Rules, 1978.
Yes
REMARKS OF EVALUATOR
Certificate No on GMP certificate in China FDA database is for another manufacturer
GMP certificate of API manufacturer issued by regulatory authority of country of origin could not be
confirmed from China FDA database.
Minutes of 294th Meeting of Registration Board | 160
Initially firm submitted stability data containing API Diclofenac Potassium from Huixian Dongpu Chemicals co
Ltd , China. GMP of Huixian Dongpu Chemicals co Ltd, China can not be verified from CFDA database.
Thereafter, the firm submitted new stability data with API source i.e Henan Dongtai Pharma co Ltd , China.
NEW STABILITY DATA SUBMITTED BY THE FIRM
Drug K-Fast 50mg Sachet
Name of Manufacturer M/s. Vision Pharmaceuticals , Plot # 22-23, Industrial Triangle, Kahuta road,
Islamabad
Manufacturer of API Henan Dongtai Pharma co Ltd , China
API Lot No. 303161222-6
Description of Pack
(Container closure system) Paper coated aluminium sachet
Stability Storage Condition Real time : 30°C ± 2°C / 65% ± 5% RH
Accelerated: 40°C ± 2°C / 75% ± 5% RH
Time Period Real time: 6 months Accelerated: 6 months
Frequency Accelerated: 0, 3,6 (month) Real Time: 0,1,2 3,4,5,6 (month)
Batch No. NPD801 A (T-01) NPD801 A (T-02) NPD801 A (T-03)
Batch Size 1000 Sachet 1000 Sachet 1000 Sachet
Manufacturing Date 10-08-2018 11-08-2018 14-08-2018
Date of Initiation 27-08- 2018 27-08- 2018 27-08- 2018
No. of Batches 3
Date of Submission 20-03-2019 (Dy. No. 1288)
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr. Documents To Be Provided Status
1. COA of API Copy of COA Henan Dongtai Pharma co Ltd ,
China is submitted
2. Approval of API by regulatory authority of country of
origin or GMP certificate of API manufacturer issued
by regulatory authority of country of origin.
Copy of GMP Certificate No.HA20170001 issued
by CFDA is attached. Valid till 22-01-2022
3. Protocols followed for conduction of stability study
and details of tests.
Yes
4. Data of 03 batches will be supported by attested
respective documents like chromatograms, laboratory
reports, data sheets etc.
Yes
5. Documents confirming import of API etc. Copy of Assistant Director (I & E) DRAP
(islamabad) attested dated: 09-01-2017 Commercial
Invoice No DT1612132Y Dated: 11-01-2017 is
submitted.
6. All provided documents will be attested (name, sign
and stamp) for ensuring authenticity of data /
documents.
Yes
7. Commitment to continue real time stability study till
assigned shelf life of the product.
Yes
8. Commitment to follow Drug Specification Rules,
1978.
Yes
Minutes of 294th Meeting of Registration Board | 161
REMARKS OF EVALUATOR
The panel may be requested to verify and report about following point in addition to authenticity of
stability data and associated documents,
Whether stability studies from both API sources performed. Initially firm submitted stability data containing
API Diclofenac Potassium from Huixian Dongpu Chemicals co Ltd , China. GMP of Huixian Dongpu Chemicals
co Ltd , China can not be verified from CFDA database. Thereafter, the firm submitted new stability data with
API source i.e Henan Dongtai Pharma co Ltd , China .
Report on Inspection for verification of Authenticity/Genuineness of data submitted by M/s. Vision
Pharmaceuticals (Pvt.) Ltd., Plot No. 22-23, Industrial Estate Triangle, Kahuta Road, Model Town,
Islamabad for registration of K-fast 50mg (Diclofenac potassium) sachet
Inspection Date and Time: 17, 18 and 19 December, 2019
Inspection Site: M/s. Vision Pharmaceuticals (Pvt.) Ltd., Plot No. 22-23 Industrial Estate Triangle, Kahuta
Road, Model Town, Islamabad.
Background:
M/s. Vision Pharmaceuticals (Pvt.) Ltd., Plot No. 22-23, Industrial Estate Triangle, Kahuta Road, Model Town,
Islamabad applied for registration of K-fast 50mg (Diclofenac potassium) sachet with following composition:
K-fast sachet 50mg
Each sachet contains:-
Diclofenac potassium…………50mg
Chairman Registration Board constituted a three member panel for on-site investigation to confirm the
genuineness/authenticity of submitted stability data and associated documents, import of API, quality,
specification, test analysis, facilities etc. Panel was requested to conduct inspection of the firm to verify the data
submitted by the firm and to submit a report on approved format for further consideration of case by the
Registration Board. The Chairman Registration Board further advised the panel to verify and report about
following point:
Initially, the firm has submitted stability studies data containing API Diclofenac potassium imported from Huixian
Dongpu Chemicals Co. Ltd, China. GMP of Huixian Dongpu Chemicals Co. Ltd, China cannot be verified from
the official database of SFDA. Thereafter, the firm submitted new stability data with new API source Henan
Dongtai Pharma Co. Ltd., China.
The Panel was requested to confirm whether the firm has conducted stability studies with each API from
two different sources. It was clarified during audit that the firm conducted stability studies with API
imported from M/s Henan Dongtai Pharm Co. Ltd., East Changhong Tangyin Henan, China only. The
firm did not continue the studies with API imported from source M/s Huixian Dongpu Chemicals Co. Ltd,
China and submitted the destruction record (Report no. 1725/NCR dated 22 March, 2019) of stability
batches manufactured from this earlier source.
Composition of Panel:
1. Dr. Qurban Ali, (Member Registration Board).
2. Mr. Babar Khan, Area FID, DRAP, Islamabad.
3. Mr. Hanifullah, Assistant Director (PEC) DRAP, Islambad.
Scope of Inspection:
On-site investigation to confirm the genuineness/authenticity of submitted stability data and associated documents
like import of API, quality specification and test analysis facilities etc.
Tools for Inspection:
The Inspection was conducted by using a structured questionnaire approved by DRAP. For objective evidence
physical inspection of the facilities for manufacturing and quality control, material used and retained, personnel
involved, ongoing studies, printed data integrity and security of data in respective databases were also audited.
The detail of inspection is summarized as under:
(Some of the observations have been highlighted as bold with bullet point against the respective question).
Minutes of 294th Meeting of Registration Board | 162
Q.
No.
Question Observation by panel
1. Do you have documents
confirming the import of
API including approval
from DRAP?
DICLOFENAC POTASSIUM
Invoice Number: DT1612132Y
Assistant Director (I & E) DRAP attestation date: 09.02.17
Exporter: M/s Henan Dongtai Pharm CO LTD, EAST CHANGHONG
TANGYIN HENAN, CHINA
Manufacturer: as above
Batch No. 303161222-6
Mfg. Date: 22-12-2016
Exp. Date: 21-12-2020
Quantity: 300Kg
2. What was the rationale
behind selecting the
particular manufacturer of
API?
The firms provide the rational that
1. Since Diclofenac Potassium is already being used at VISION
PHARMACEUTICALS PVT. LTD. in the product Diclofenac Potassium
32% pellets since quite long, therefore, based on the track record of HENAN
DONGTAI PHARM CO. LTD. the API source is validated and use of same
source is preferred rather than going for an unknown source.
2. The documents of source, HENAN DONGTAI PHARM CO. LTD.,
are more authentic.
The firm has submitted a document comparing the parameters
between two sources namely M/s Henan Dongtai Pharm Co. Ltd. China and
M/s Huxian Doungpu Chemicals Co. Ltd. China. The document shows the
concluding remarks that M/s Henan Dongtai Pharm Co. Ltd. China will be
the preferred source with date of 28th August, 2018. While the firm mentioned
the manufacturing date of 10th August 2018, 11th August 2018 and 14th August
2018 in the stability studies for the batch # NPD801 (T-01), NPD801 (T-02)
and NPD801 (T-03) respectively. This means that the source was qualified
after the API has been used in the manufacturing of Finished product batches.
3. Do you have documents
confirming the import of
Diclofenac potassium
reference standard and
impurity standards?
The firm imported following reference standard and impurity standard:
Diclofenac potassium primary reference standard from the USP (Lot
No. R034L0)
o Order placing date: 08 June, 2018
o Shipment date:11.06.2018
o Commercial Invoice no. 31068571(Dated 11 June, 2018)
o AD attestation date 11.07.2018
Firm has also imported impurity (Diclofenac related compound A
USP RS) for identification/quantification of specified impurities from
Pharmaffiliates:
o Invoice no. EXP/2019-20/121 dated 21.06.2019
o Lot no. PA/ACE/01109
o AD attestation date 11.07.2018
4. Do you have certificate of
Analysis of the API,
reference standards and
impurity standards?
The firm has submitted COAs of API, reference standards and impurity
standards as per details below:
Diclofenac potassium API from Henan Dongtai Pharm CO.LTD
(for Batch No.303161222-6)
Diclofenac potassium primary reference standard USP (Lot No.
R034L0)
Diclofenac potassium Impurity A RS USP from Pharmaffiliates (Lot
no. PA/ACE/01109).
5. Do you have GMP
certificate of API
manufacturer issued by
The firm has submitted copy of GMP certificate No:HA20170001 in the name
of Manufacturer that is “M/s Henan Dongtai Pharm Co. Ltd, East Changhong
Road, Tangyin County, Anyang City, China” for API Diclofenac Potassium
USP issued by HeNan Province Food and Drug Administration.
Minutes of 294th Meeting of Registration Board | 163
regulatory authority of
country of origin?
Issuing date: 23-01-2017
Valid till: 22-01-2022
The name of city “Anyang” is mentioned on GMP while it is not
mentioned on COA.
6. Do you use API
manufacturer method of
testing for testing API?
The firm stated that they have used pharmacopoeial (USP) method for testing
of API as per statement of API source.
7. Do you have stability
studies reports on API?
Firm has submitted data of long term stability studies of three batches 131118-
5 (Mfg: 18th Nov, 2013), 131118-6 (Mfg: 18th Nov, 2013) & 131119-5 (Mfg:
18th Nov, 2013) conducted by the API manufacturer M/s Henan Dongtai
Pharm Co Ltd, East Changhong Tangyin Henan, China, under conditions of
Zone-IV A that is 30 Co + 2 Co & 65 % RH + 5 % (for real time studies) up
to 48 months and 40 Co + 2 Co & 75 % RH + 5 % (for accelerated studies) up
to 6 months for API namely Diclofenac potassium. The data submitted by the
API manufacturer lies within the limits for the Assay & related impurities.
Parameter like pH, viscosity etc. have not been tested by API
manufacture in its studies for stability.
Typo-mistake in limit of impurity A has been noticed that is “NMT
0.15 %” has been mentioned instead of “NMT 0.1 %” in stability studies of
batch no. 131119-6 in real time studies.
8. If yes, whether the stability
testing has been performed
as per SIM method and
degradation products have
been quantified?
Since the manufacturer has conducted the stability studies using USP
compendia in which they have quantified the impurities as per
pharmacopoeia, which gives sense that the studies have been conducted as per
SIM method.
9. Do you have method for
quantifying the impurities
in the API?
Yes, they have used USP method for quantifying the impurities in the API.
10. Do you have some
remaining quantities of the
API, its reference standard
and impurities standards?
Yes, they have remaining quantities of the API, reference standard and
impurities standards as per details given in the following table which have
been verified by the panel during the visit:
Raw Material Lot No. Place of
Consumption
Quantity
Diclofenac
Potassium
303161222-6 NPD801(T-01) 50 gram
NPD801(T-02) 50 gram
NPD801(T-03) 50 gram
Total Quantity 300kg
Quantity
Consumed
150grams
Remaining
Quantity
299.85kg (Rest used in commercial
manufacturing)
Item Type Lot No. Total Quantity Remaining
Quantity
Diclofenac
Potassium
Reference
Standard
R034LO 200mg 125mg
Item Type Lot No. Total Quantity Remaining
Quantity
Diclofenac
Potassium
Related
Compound A
PA/ACE/01109 25mg 10mg
Minutes of 294th Meeting of Registration Board | 164
11. Have you used
pharmaceutical grade
excipients?
The firm has used following excipients of pharmaceutical grade except flavors
Anise and Mint:
S. No. Excipients Pharma grade
1 Sucralose BP
2 Mannitol BP/USP/EP
3 Aspartame BP
4 Potassium Hydrogen
Carbonate
BP
5 Anise Flavour Manufacturer’s Specification
6 Mint Flavour Manufacturer’s Specification
The firm has used flavors Anise and Mint which were of
manufacturer’s specifications.
12. Do you have documents
confirming the import of
the used excipients?
The firm has imported only one excipient MANNITOL for the applied
formulation through exporter M/s HANGZHOU STARSHINE
PHARMACEUTICAL CO LTD (Room B2, 10F, Tianyuan Building, No.508
Wensan Road, Hangzhou, China) from the manufacturer M/s SHANDONG
TIANLI PHARMACEUTICAL CO LTD (South of Anshun Street and West
of Xingyuanxi Road, Gucheng subdistrict office, Shouguang, Shandong,
China) with Batch No. 301802314, manufacturing date:15th Feb, 2018 Expiry
Date: 14th Feb, 2020.
The firm acquired following other raw material excipients from local suppliers
as per details below:
The firm procured the excipient from local supplies. The firm has
developed an SOP for vendor qualification but above listed suppliers are not
included in the approved list of vendor suppliers.
S.No. Excipient Supplier Batch No.
1. Sucralose Global
Laboratories
A17071614
2. Aspartame National
Trading
W 16121510
3. Potassium
Hydrogen
Carbonate
Carbonate
Musaji
Adam &
Sons
PO201PD1
4. Anise Hamza
Traders
24151
5.. Mint Hamza
Traders
24152
13. Do you have test reports
and other records on the
excipients used?
The firm has performed tests on the excipients as per details below:
S. No. Excipients Report No. Release Date
1 Sucralose 0916/RM/17 15.12.2017
2 Mannitol 0414/RM/18 30.05.2018
3 Aspartame 0264/RM/17 10.04.2017
4 Potassium Hydrogen
Carbonate
0417/RM/18 31.05.2018
5 Anise Flavour 0409/RM/18 29.05.2018
6 Mint Flavour 0410/RM/18 29.05.2018
The firm did not acquire COAs of above excipient before purchase or
during vendor qualifications. However, the firm provided COA of all
excipients during audit.
The QC report for Sucralose have no signature of QA Manager for
release of excipient.
Some tests done by source like tests for microorganism for Sucralose
(artificial sweetner) but not performed by firm.
Minutes of 294th Meeting of Registration Board | 165
14. Do you have written and
authorized protocols for the
development of K-FAST
50mg Sachet (Diclofenac
Potassium)?
The firm has written and authorized protocols No.RD/PD/001 for the
development of K-FAST 50mg Sachet (Diclofenac Potassium) in accordance
with ICH Q-8 Pharmaceutical Development guidelines.
15. Have you performed Drug-
excipients compatibility
studies?
The firm has not performed Drug-Excipients compatibility studies. They have
submitted the reason/logic for this that as their formulation (API &
Excipients) is similar/comparable to that of Voltfast sachet of Novartis
Pharma, Switzerland approved by Swissmedics. The quantities of sweetening
agents that is Sucralose and Aspartame were within safe limits as per USFDA
inactive ingredient database.
The firm referred the product approved by the Swiss Medic which
contains Aspartame and saccharine sodium. Hence, the firm should perform
compatibility studies.
16. Have you performed
comparative dissolution
studies?
The comparative dissolution studies have not been performed by the firm.
However, the firm has performed comparative assay, LOD and pH studies in
comparison with Voltfast to which firm is referring as reference product. This
so-called reference product seemed approved by UAE drug agency as it
contains UAE: NDC 4924-6116-01-03 & NAFDAC Reg. No. 04-9014.
Though it is mentioned on box that it is manufactured by M/s Miphar S.p.A.,
Milan, Italy for M/s Novartis Pharma AG, Basle, Switzerland.
It was advised to the firm to perform comparative dissolution profile
according to WHO guidelines in at least 3 different media of pH 1.2, 4.5 &
6.8 (to simulate the in vivo absorption site) in comparison with the reference
product approved by reference drug agency.
The firm has been using sucralose and aspartame in the formulation
while the product to which they are referring as reference product namely
Voltfast contains aspartame and saccharine sodium.
17. Do you have product
development (R&D)
section
The firm possesses a Research & Development (R&D) section for product
development studies.
18. Do you have necessary
equipment available in
product development
section for development of
K-fast?
Yes, the firm has following necessary equipment in R & D section though for
the development of K-fast sachet. Following is the list of equipments. Sr.
No.
Equipment Name Equipment
ID
Qualification
Date
1 Multi Functional
Pharmaceutical R&D
Machinery
VP/RD/001 20 July 2016
2 Bag Forming Filling
Sealing Machine
DXDK80CH 04 Feb 2016
19. Are the equipments in
product development
section qualified?
The following equipments used in production and analysis of trial batches are
qualified. S.
No.
Equipment Name Equipment
ID
Qualification
Date
1 Multi Functional
Pharmaceutical R&D
Machinery
VP/RD/001 20 July 2016
2 Bag Forming Filling
Sealing Machine
DXDK80CH 04 Feb 2016
20. Do you have proper
maintenance/calibration/re-
qualification program for
The firm has maintenance/calibration program for the equipment used in R &
D as per following details.
Minutes of 294th Meeting of Registration Board | 166
the equipment used in PD
section?
S. No. Equipment Name Equipment ID Last Maintenance
Date
1 Multi Functional
Pharmaceutical R&D
Machinery
VP/RD/001 October 2019
2 Bag Forming Filling
Sealing Machine
DXDK80CH October 2019
21. Do you have qualified staff
in product development
section with proper
knowledge and training in
product development?
The firm has provided the details of their technical personnel involved in the
development of K-fast Sachet.
The above technical persons were involved in the development of
product and however persons at S.No.1, 2, 4, 6 & 7 have now left the firm.
Dr. Zia ud Din, Chief Operating Officer/TD (Technical Director) also
meet the panel on last day of inspection to detail about the formulation
development.
S.No. Name Designation Qualification Experience
1 Dr. Zia Ud
Din
Chief
Operating
Officer/ TD
(Technical
Director)
B Pham
(Pak), PGD
(UK), MS
(UK)
27 Years
2 Aatikah
Younis
Manager
R&D
Pharm-D 9 Years
3 Humera
Iqbal
Manager QC M.Sc
Chemistry
21 Years
4 Saima
Yasmeen
Assistant
Manager QC
Pharm-D 9 Years
5 Altaf
Usmani
Deputy
Manager QA
M.Sc
Chemistry
13 Years
6 Muhammad
Mudassar
Ali
Assistant
Manager
R&D
Pharm-D 5 Years
7 Laila Tul
Qadar
R&D Officer Pharm-D 3 Years
22. Have you manufactured
three stability batches for
the stability studies of K-
FAST Sachet as required?
The firm has manufactured following three stability batches for the stability
studies of K-fast Sachet:
S. No. Stability Batches Batch Sizes
1. NPD801(T-01) 3kg
2. NPD801(T-02) 3kg
3. NPD801(T-03) 3kg
23. Do you have any criteria for
fixing the batch size of
stability batches?
The firm has set the criteria for fixing the batch size of stability batches based
on the quantity sufficient for testing during the studies both for accelerated
and real time studies to cover all testing time points.
Trial
No.
Batch
Size
Theoretical
Quantity
Actual
Packs
Yield
Packs
for
Real
Time
Packs for
Accelerated
Total
Packs
Required
Trial
No 1
3 Kg 1000
Sachets
30
Packs
8
Packs
7 Packs 15 Packs
Trial
No 2
3 Kg 1000
Sachets
30
Packs
8
Packs
7 Packs 15 Packs
Trial
No 3
3 Kg 1000
Sachets
30
Packs
8
Packs
7 Packs 15 Packs
24. Do you have complete
record of production of
stability batches?
The firm has complete record of production of stability batches. The firm has
shown the BMR of all three batches showing the complete history of
manufacturing and testing of batches step by step:
NPD801 (T-01) 3 Kg
NPD801 (T-02) 3 Kg
NPD801 (T-03) 3 Kg
Minutes of 294th Meeting of Registration Board | 167
25. Do you have protocols for
stability testing of stability
batches?
The firm has controlled protocol no. SOR 03544 for testing the stability
batches of applied formulation at 30 Co + 2 Co & 65 % RH + 5 % for real time
studies and at 40 Co + 2 Co & 75 % RH + 5 % for accelerated studies with
them.
26. Do you have developed and
validated the method for
testing of stability batches?
The firm has used pharmacopoeia (USP) method of Diclofenc potassium
tablets for testing of Diclofenac potassium sachet and validate this method
through their method validation protocol No: MVP/032/2018 for batch No:
NPD801. The firm has also submitted a report No: MVR/032/2018 for batch
No: NPD801 T01 verifying the validation studies of the analytical method
covering following parameters of validation as defined in compendia:
i.Specificity
ii.Precision
iii.Repeatability
iv.Accuracy and recovery
v.Ruggedness
vi.Robustness
vii.Linearity and range
27. Do you have method
transfer studies in case
when the method of testing
being used by your firm is
given by any other lab?
The firm has not conducted method transfer studies. The firm submitted that
since they have developed the method from pharmacopoeia (Pharmacopoeial
method of tablets) in their own laboratory and they have validated it so there
is no need to do such studies.
28. Do you have documents
confirming qualification of
equipment/ instruments
being used in the test and
analysis of APIs and
finished drugs.
The firm showed documents like Report No.2477 dated 16.05.2019 by
Kamstec International authorized by Waters (the firm showed the evidence
from the website for this authorization), confirming the qualification of HPLC
(Waters e 2695) being used in the test and analysis of APIs and the finished
drug.
29. Do your method of analysis
stability indicating?
The firm has performed SIM studies on the product and covering aspects like
Photolytic degradation, peroxide degradation, thermal degradation, acid
degradation, and base degradation studies for 72 hours.
The number of theoretical plates and tailing factor are missing in the
chromatograms.
30. Do your HPLC software is
21CFR compliant?
Complete product development as well as stability studies have been
performed on 21CFR complaint HPLC (Waters e 2695) with software version
Empower 3 Software database version 7.40.00.00 Waters 2002-2017.
31. Can you show Audit Trail
reports on K-fast sachet?
Yes, the firm has showed the audit trail record. Moreover, record and
chromatograms are attached with stability record. It has a limited/controlled
access as well.
32. Do you have some
remaining quantities of
degradation products and
stability batches?
The firm has remaining quantities of stability batches as per following details:
NPD801 (T-01) 6 packs
NPD801 (T-02) 6 Packs
NPD801 (T-03) 6 Packs
33. Do you have stability
batches kept on stability
testing?
The firm has completed the accelerated stability testing on the three stability
batches of K-fast Sachet. Also the firm has completed the real time stability
testing up to 12 months on all three batches with satisfactory results.
34. Do you have valid
calibration status for the
equipments used in
production in analysis?
The firm has valid calibration status for the equipment used in K-fast Sachet
production and analysis as detailed in following table. S.
No.
Equipment Name Equipment ID Last
calibration
date
Last calibration
date
Minutes of 294th Meeting of Registration Board | 168
1 Multi Functional
Pharmaceutical R&D
Machinery
VP/RD/001 October 2019 October 2019
2 Bag Forming Filling
Sealing Machine
DXDK80CH October 2019 October 2019
35. Do proper and continuous
monitoring and control are
available for stability
chamber?
Continuous power supply and monitoring with back up of 1 kv generator is
available for stability chamber to address the problem of load shedding and
for continuous/uninterrupted power supply. Portable digital data loggers are
available for continuous monitoring of temperature and humidity conditions
of stability chamber. The firm submitted date-wise data of temperature and
humidity conditions of stability chambers used for accelerated and real time
studies for every next hour.
36. Do related manufacturing
area, equipment, personnel
and utilities be rated as
GMP compliant?
The related manufacturing area, equipment, personnel and utilities are rated
as GMP compliant.
The firm was advised to increase the capacity of the R&D in terms of facilities,
technical staff and training thereof.
Conclusions & Recommendations:
1. It was clarified during audit that the firm conducted stability studies with API imported from M/s Henan
Dongtai Pharm Co. Ltd., East Changhong Tangyin Henan, China only. The firm did not continue the studies with
API imported from source M/s Huixian Dongpu Chemicals Co. Ltd, China and submitted the destruction record
(Report no. 1725/NCR dated 22 March, 2019) of stability batches manufactured from this earlier source.
2. On the basis of risk based approach, the genuineness/authenticity of stability data submitted by the firm
for registration of K-Fast Sachet is verifiable to an acceptable/satisfactory level. However, during audit it was
revealed that the firm is not clear regarding reference product compare to which they would have to establish the
formulation and perform pharmaceutical development studies. Earlier, they referred the brand “Cambia” of
Assertio as their reference product whose formulation was found as different (e.g., mannitol has been used with
specific particle size) from the applied one by the panel. It is hence, recommended that the assessment related to
formulation and manufacturing technology may be carried out again by PEC so as to ascertain/ensure the
similarity/comparability of same in the light of approval by reference agency(ies) before grant of registration by
the Registration Board.
3. The related manufacturing area, equipment, personnel and utilities are GMP compliant and suitable for
the manufacturing of K-fast 50mg (Diclofenac potassium) sachet therefore, the panel recommends the registration
of K-fast 50mg (Diclofenac potassium) sachet in the name of the manufacturer.
Evaluation by PEC:
Firm submitted an undertaking that their reference product was Voltfast Sachet 50mg of Swissmedic.
The assessment related to formulation and manufacturing technology may be carried out again by PEC
and it is revealed that firm follow manufacturing process of Voltfast of Swissmedic
Firm submitted dissolution and compare it with Voltfast Sachet 50mg of Swissmedic. Valaue of Q is
greater than 90% in 5 minutes.
Excipients are different from Voltfast Sachet 50mg but they did not perform compatibility studies.
Decision: Registration Board after thorough deliberation decided to defer the case for re
evaluation of the firm’s applied formulation and the USFDA as well as Swissmedic approved
reference product by Pharmaceutical Evaluation Cell.
Item No. 6: Agenda of Evaluator PEC-V CLB in its 273rd meeting held on 15th Jan, 2020 considered the case of M/s D-Haans Pharmaceuticals.Plot No.
9/A, Industrial Estate, Bhimber Pakistan and approved the grant of DML by way of formulation with following
sections.
New Approved Sections
S. No Section No. of products No. of molecules
1. Oral Powder Section-I (Vet) 32 10
2. Oral Powder Section-II (Vet) 20 10
Minutes of 294th Meeting of Registration Board | 169
Oral Powder Section-I (Vet)
10 Molecules 10 Products
109. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Hascoli-50% W/S Powder
Composition "Each 100g Contains:
Colistin Sulphate…50g"
Diary No. Date of R&I &fee Dy.No 1879 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 053941; CN-Mont Oral Powder
M/s Westmont Pharmaceuticals Industry Rawalpindi"
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Referred to expert working group for rationalization of colistin formulations.
110. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Hascoli-400 W/S Powder
Composition "Each 100g Contains:
Colistin Sulphate…400 MIU"
Diary No. Date of R&I &fee Dy.No 1876 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 049783
Coliser Water Soluble Powder M/s Attabak Pharma
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Referred to expert working group for rationalization of colistin formulations.
111. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Hascoli-500 W/S Powder
Composition "Each 100g Contains:
Colistin Sulphate…500 MIU"
Diary No. Date of R&I &fee Dy.No 1877 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 049784; Colibak Forte WSP Water Soluble Powder
M/s Attabak Pharma Islamabad
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Minutes of 294th Meeting of Registration Board | 170
Remarks of the Evaluator
Decision: Referred to expert working group for rationalization of colistin formulations.
112. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Hascoli-600 W/S Powder
Composition "Each g Contains:
Colistin Sulphate…600,000IU"
Diary No. Date of R&I &fee Dy.No 1878 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification Imhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 089855; Neflorex 60 Water Soluble Powder
M/s. Breeze Pharma (Pvt) Ltd., Kahuta Road, Islamabad.
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Referred to expert working group for rationalization of colistin formulations.
113. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Hansredin 1% Powder
Composition "Each 1000g Contains:
Amantadine HCl…10g"
Diary No. Date of R&I &fee Form-5 Dy.No 1882 (19-02-2020) Rs.20,000/- (17-02-2020)
Pharmacological Group Antiviral
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 075697; Amantabak Powder
"M/s Attabak Pharmaceuticals, Industrial Area, Islamabad."
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
114. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Hansredin 10% Powder
Composition "Each 100g Contains:
Amantadine HCl…10g"
Diary No. Date of R&I &fee Form-5 Dy.No 1881 (19-02-2020) Rs.20,000/- (17-02-2020)
Pharmacological Group Antiviral
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 088040 ; "Metadine powder
"M/S. Farm Aid Group, Hattar Industrial Estate, Haripur"
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Minutes of 294th Meeting of Registration Board | 171
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
115. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Hansredin 98% Powder
Composition "Each 100g Contains:
Amantadine HCl…98g"
Diary No. Date of R&I &fee Form-5 Dy.No 1880 (19-02-2020) Rs.20,000/- (17-02-2020)
Pharmacological Group Antiviral
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 093841; Amadine-98 Oral Powder
"M/S. Aptly Pharmaceuticals, Faisalabad."
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
116. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Hansydox-80% Powder
Composition "Each g Contains:
Doxycycline HCl…800mg"
Diary No. Date of R&I &fee Dy.No 1884 (19-02-2020) Rs.20,000/- (17-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 082504; "Doxyral 80% Water Soluble Powder For Oral Route
"M/s. Orient Animal Health (Pvt.) Limited, Karachi-75100"
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator The drug already approved by DRAP (generic / me-too status)
provided by you mention “Doxycycline hyclate…...923.32mg
(eq. To 800mg doxycycline)” whereas, you have applied for
“Doxycycline HCl…800mg".
Decision: Deferred for revision of formulation as per the DRAP approved generic product along
with submission of requisite fee.
117. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Hansydox-50% Powder
Composition "Each g Contains:
Doxycycline HCl…500mg"
Diary No. Date of R&I &fee Dy.No 1883 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 096840; Doxson Oral W/S Powder "M/s. D-Maarson
Pharmaceuticals, National Industrial Zone,Rawat, Islamabad."
Minutes of 294th Meeting of Registration Board | 172
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
118. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Neo-Hans 60% W/S Powder
Composition "Each 100g Contains:
Neomycin Sulphate…60g"
Diary No. Date of R&I &fee Dy.No 1887 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 069625; Neocin-S Water Soluble Powder M/s Alina Combine
Pharmaceuticals (Pvt) Ltd., Karachi.
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
119. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Neo-Hans 70% W/S Powder
Composition "Each 100g Contains:
Neomycin Sulphate…70g"
Diary No. Date of R&I &fee Dy.No 1886 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 075694; Neomycin 70% Powder
"M/s Attabak Pharmaceuticals, Industrial Area, Islamabad."
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
120. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Neo-Hans 72% W/S Powder
Composition "Each 100g Contains:
Neomycin Sulphate…72g"
Diary No. Date of R&I &fee Dy.No 1885 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 078297; N-72 Water Soluble Powder "M/s. Nawal
Pharmaceuticals, Rawalpindi"
Minutes of 294th Meeting of Registration Board | 173
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Deferred for scientific rational for neomycin 72% water soluble powder, since neomycin
70% water soluble powder is already approved.
121. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Linc-Hans 1.1% Powder
Composition "Each 100g Contains:
Lincomycin HCl…1.1g"
Diary No. Date of R&I &fee Dy.No 1889 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 031403; Lincofeed Oral Powder
M/s Mediexcel Pharmaceuticals, Islamabad.
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator The drug already approved by DRAP (generic / me-too status)
provided by you mentions “Lincomycin HCl monohydrate
1.1g.whereas, you have applied for Lincomycin HCl …1.1g.
Decision: Approved with innovator’s specification and with following label claim.
Each 100g Contains:
Lincomycin HCl monohydrate……1.1g
122. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Linc-Hans 11% Powder
Composition "Each 100g Contains:
Lincomycin HCl…11g"
Diary No. Date of R&I &fee Dy.No 1888 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 078267; Dm-Premix
"M/S. D-Maarson Pharmaceuticals, Rawat, Islamabad."
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
123. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Linc-Hans 4.4% Powder
Composition "Each 100g Contains:
Lincomycin HCl…4.4g"
Diary No. Date of R&I &fee Dy.No 1890 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Antibacterial
Minutes of 294th Meeting of Registration Board | 174
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 049667
Lincos-P Powder M/s A & K Pharmaceutical, Faisalabad.
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
124. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Linc-Hans 44% Powder
Composition "Each 100g Contains:
Lincomycin HCl…44g"
Diary No. Date of R&I &fee Dy.No 1891 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 080157; Licogrow-44 Oral Powder
"M/s. Ras Pharmaceuticals (Pvt) Ltd., Multan."
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
125. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Hanster-30% W/S Powder
Composition "Each 100g Contains:
Amprolium HCl…30g"
Diary No. Date of R&I &fee Dy.No 1892 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Anticoccidial
Type of Form Form 5
Finished product Specification USP
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 063816; Amprobak-30 Water Soluble Powder.
M/s Attabak Pharmaceuticals Islamabad
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved.
126. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Hanster-50% W/S Powder
Composition "Each 100g Contains:
Amprolium HCl…50g"
Diary No. Date of R&I &fee Dy.No 1884 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Anticoccidial
Minutes of 294th Meeting of Registration Board | 175
Type of Form Form 5
Finished product Specification USP
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 072631; Ampro Powder
"M/s Nawal Pharmaceuticals, Rawalpindi."
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator The drug already approved by DRAP (generic / me-too status)
provided by you mentions “Amprolium as HCl”, whereas, you
have applied for “Amprolium HCl”.
Decision: Approved.
127. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Hanster-60% W/S Powder
Composition "Each 100g Contains:
Amprolium HCl…60g"
Diary No. Date of R&I &fee Dy.No 1895 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Anticoccidial
Type of Form Form 5
Finished product Specification USP
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 046673; Amprox 60% Water Soluble Powder
M/s Alina Combine Pharmaceuticals (Pvt) Ltd. Karachi.
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved.
128. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Hanster-90% W/S Powder
Composition "Each 100g Contains:
Amprolium HCl…90g"
Diary No. Date of R&I &fee Dy.No 1893 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Anticoccidial
Type of Form Form 5
Finished product Specification USP
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 053917; Amcox Powder
M/s Attabak Pharmaceuticals Islamabad.
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved.
129. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Hanster-100% W/S Powder
Composition "Each 100g Contains:
Minutes of 294th Meeting of Registration Board | 176
Amprolium HCl…98g"
Diary No. Date of R&I &fee Dy.No 1896 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Anticoccidial
Type of Form Form 5
Finished product Specification USP
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 088630; "Ampro-Forte Oral Powder
"M/s. Breeze Pharma (Pvt) Ltd., Kahuta Road, Islamabad."
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved.
130. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Respi-Hans 10% Powder
Composition "Each Kg Contains:
Oxytetracycline HCl…100g"
Diary No. Date of R&I &fee Dy.No 1900 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification BP
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 049713; Polyqueen Gold Water Soluble Powder.
M/s Attabak Pharmaceuticals, Islamabad.
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved.
131. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Respi-Hans 20% Powder
Composition "Each Kg Contains:
Oxytetracycline HCl…200g"
Diary No. Date of R&I &fee Dy.No 1898 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification BP
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 029637; FA-TM-200 Powder
M/s Farm Aid Group Pakistan, Hattar, Haripur, N.W.F.P.
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved.
132. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Respi-Hans 50% Powder
Composition "Each Kg Contains:
Minutes of 294th Meeting of Registration Board | 177
Oxytetracycline HCl…500g"
Diary No. Date of R&I &fee Dy.No 1899 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification BP
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 063643; Nobitet 50% Powder
M/s Noble Pharma, Industrial Area, Mirpur Azad Kashmir.
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved.
133. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Respi-Hans 95% Powder
Composition "Each Kg Contains:
Oxytetracycline HCl…950g"
Diary No. Date of R&I &fee Dy.No 1897 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification BP
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 034526; Oxy-950 Powder
M/s Attabak Pharmaceutical Industries, Islamabad.
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved.
134. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Neo-Cin W/S Powder
Composition "Each 100g Contains:
Florfenicol…15g
Neomycin Sulphate…15g"
Diary No. Date of R&I &fee Dy.No 1901 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 087961; "Neo Flor Water Soluble Powder
M/s. Farm Aid Group, Hattar Industrial Estate, Haripur."
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
135. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength FLO-OTC W/S Powder
Minutes of 294th Meeting of Registration Board | 178
Composition "Each 100g Contains:
Oxytetracycline HCl…15g
Florfenicol…15g"
Diary No. Date of R&I &fee Dy.No 1902 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 080726; Oxy-Floro Water Soluble Powder
"M/s. Intervac (Pvt) Ltd., Sheikhupura."
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
136. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength FLO-OTC 30 W/S Powder
Composition "Each 100g Contains:
Oxytetracycline Hcl…30%
Florfenicol…30%"
Diary No. Date of R&I &fee Dy.No 1903 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 063747; Ampronil-50 Oral Powder
M/s Westmont Pharmaceutical Industry, Rawalpindi
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
137. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Tylohans-D20 Powder
Composition "Each 100g Contains:
Doxycycline HCl…20g
Tylosin Tartrate…10g"
Diary No. Date of R&I &fee Dy.No 1906 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 072630; Doxytyl Oral Powder.
"Each 100gm Contains:-
Tylosin ……………..10gm.
Doxycycline ………. 20gm.
M/s Nawal Pharmaceuticals, Rawalpindi."
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Minutes of 294th Meeting of Registration Board | 179
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator The drug already approved by DRAP (generic / me-too status)
provided by you mentions “Each 100g contains:-
Tylosin……..10g, Doxycycline. 20g whereas, you have
applied for Doxycycline HCl…20g, Tylosin Tartrate…10g".
Decision: Deferred for revision of formulation as per the DRAP approved generic product along
with submission of requisite fee.
138. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Tylohans-D25 Powder
Composition "Each 100g Contains:
Doxycycline HCl…25g
Tylosin Tartrate…20g"
Diary No. Date of R&I &fee Dy.No 1907 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 031434; Tylo-Cycline 450 Powder
M/s Farm Aid Group Pakistan, Hattar.
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
139. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Tylohans-D40 Powder
Composition "Each 100g Contains:
Doxycycline HCl…40mg
Tylosin Tartrate…20g"
Diary No. Date of R&I &fee Dy.No 1905 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator Me to couold not be confirmed.
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic
/ me-too status) alongwith registration number, brand name and name of firm.
140. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Tylohans-D60 Powder
Composition "Each 100g Contains:
Doxycycline HCl…40g
Tylosin Tartrate…20g"
Diary No. Date of R&I &fee Dy.No 1905 dated 19-02-2020 Rs.20,000/- (17-02-2020)
Pharmacological Group Antibacterial
Minutes of 294th Meeting of Registration Board | 180
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 069628, Dot Powder
M/s Attabak Pharmaceutical, Islamabad."
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
Oral Powder Section-II (Vet)
10 Molecules 10 Products
141. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength CRD HAANS-42 W/S Powder
Composition "Each 100g Contains:
Doxycyline Hcl…40g
Tylosin Tartrate…20g
Colistin Sulphate…6g
Bromhexine Hcl…2g"
Diary No. Date of R&I &fee Dy.No 2053 dated 20-02-2020 Rs.20,000/- (20-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 062127; NOBI TDC 680 Oral Powder.
"Each 1000gm Contains: -
Tylosin Tartarte…..200gm.
Doxycycline Hcl….400gm.
Colistine Sulphate…60gm.
Bromhexine……….20gm.
"M/S Noble Pharma, Mirpur Azad Kashmir."
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Deferred for revision of formulation as per the DRAP approved generic product along
with submission of requisite fee.
142. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength CRD HAANS-66 W/S Powder
Composition "Each 100g Contains:
Doxycyline Hcl…20g
Tylosin Tartrate…10g
Colistin Sulphate…3g
Bromhexine Hcl…10g"
Diary No. Date of R&I &fee Dy.No 2056 dated 20-02-2020 Rs.20,000/- (20-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 044951; Biosin Td Powder.
"Each 100gm Contains:-
Minutes of 294th Meeting of Registration Board | 181
Tylosin Tartrate……… 10gm.
Doxycycline…………. 20gm.
Bromhexine………….. 10gm.
Colistin Sulphate ……. 3gm.
M/s Leads Pharma (Pvt) Ltd., Islamabad.
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator The drug already approved by DRAP (generic / me-too status)
provided by you mentions: “Doxycycline……20g
,Bromhexine…10g” whereas, you have applied for
“Doxycyline HCl…20g,Bromhexine HCl…10g"
Decision: Deferred for revision of formulation as per the DRAP approved generic product along
with submission of requisite fee.
143. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength CRD HAANS-70 W/S Powder
Composition "Each 100g Contains:
Doxycyline Hcl…40g
Tylosin Tartrate…20g
Colistin Sulphate…10g
Bromhexine Hcl…2g"
Diary No. Date of R&I &fee Dy.No 2054 dated 20-02-2020 Rs.20,000/- (20-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 058962; Brocotyd Powder
"Each 100gm Contains: -
Doxycycline Hyclate…Bp…40gm
Tylosin Tartrate…Bp….20gm
Colistin Sulphate….Bp…10gm
Bromhexine Hcl….Bp…2gm
M/s Univet Pharmaceutical Rawalpindi
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator The drug already approved by DRAP (generic / me-too status)
provided by you mentions “Doxycycline Hyclate…40g”
whereas, you have applied for “Doxycyline Hcl…40g”.
Decision: Deferred for revision of formulation as per the DRAP approved generic product along
with submission of requisite fee.
144. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength CRD HAANS-100 W/S Powder
Composition "Each 1000g Contains:
Doxycyline Hcl…400g
Tylosin Tartrate…200g
Colistin Sulphate…500 MIU
Bromhexine Hcl…10g"
Diary No. Date of R&I &fee Dy.No 2052 dated 20-02-2020 Rs.20,000/- (20-02-2020)
Pharmacological Group Antibacterial / Expectorant
Type of Form Form 5
Minutes of 294th Meeting of Registration Board | 182
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 074096; Dox-40 Water Soluble Powder
"M/s. Nawal Pharmaceuticals, Rawalpindi."
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
145. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength CRD HAANS-300 W/S Powder
Composition "Each 1000g Contains:
Doxycyline Hcl…200g
Tylosin Tartrate…100g
Colistin Sulphate…500 MIU
Bromhexine Hcl…5g"
Diary No. Date of R&I &fee Dy.No 2055 dated 20-02-2020 Rs.20,000/- (20-02-2020)
Pharmacological Group Antibacterial / Expectorant
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 049712; CRD-RAZE Water Soluble Powder.
"Each 1000gm Contains:-
Tylosine Tartrate (Bp) 100gm.
Doxycycline Hydrochloride (Bp) 200gm.
Colistin Sulphate (Bp) 500 Miu.
Bromohexine Hcl (Bp) 5gm.
M/S Attabak Pharmaceuticals, Islamabad
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
146. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength CRD Haans-450 W/S Powder
Composition "Each 1000g Contains:
Doxycyline Hcl…130g
Tylosin Tartrate…170g
Colistin Sulphate…30g
Bromhexine Hcl…5g"
Diary No. Date of R&I &fee Dy.No 2057 dated 20-02-2020 Rs.20,000/- (20-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 071036; Tylodox+BC Powder of M/s Intervac (Pvt) Ltd.
"Each Kg Water Soluble Powder Contains:-
Tylosin Tartrate……..170gm
Doxycycline HCl……130gm
Bromhexine…………..5gm
Colistin Sulphate…….30gm
Minutes of 294th Meeting of Registration Board | 183
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator The drug already approved by DRAP (generic / me-too status)
provided by you mentions “Bromhexine” whereas, you have
applied for “Bromhexine Hcl”.
Decision: Deferred for revision of formulation as per the DRAP approved generic product along
with submission of requisite fee.
147. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Sulpamed-30 W/S Powder
Composition "Each 100g Contains:
Oxytetracycline Hcl…25g
Colistin Sulphate…30 MIU
Neomycin Sulphate…25g"
Diary No. Date of R&I &fee Dy.No 2059 dated 20-02-2020 Rs.20,000/- (20-02-2020)
Pharmacological Group Antibiotic
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 071068; Oxycol Forte Powder.
"Each 1000gm Contains:-
Oxytetracycline Hcl 250gm.
Neomycin Sulphate 250gm.
Colistin Sulphate 300miu.
"M/s Attabak Pharmaceutical, Islamabad."
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
148. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Sulpamed-50 W/S Powder
Composition "Each 100g Contains:
Oxytetracycline Hcl…20g
Colistin Sulphate…24 MIU
Neomycin Sulphate…20g"
Diary No. Date of R&I &fee Dy.No 2058 dated 20-02-2020 Rs.20,000/- (20-02-2020)
Pharmacological Group Antibiotic
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 074074; Clorytin Water Soluble Powder
"Each 100g Contains:-
Oxytetracycline Hcl…20g
Neomycin Sulphate ….20g
Colistin Sulphate….24MIU
"M/s. D-Maarson Pharmaceuticals, Rawat, Islamabad."
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Minutes of 294th Meeting of Registration Board | 184
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
149. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Sulpamed-60 W/S Powder
Composition "Each 100g Contains:
Oxytetracycline Hcl…20g
Colistin Sulphate…20g
Neomycin Sulphate…20g"
Diary No. Date of R&I &fee Dy.No 2060 dated 20-02-2020 Rs.20,000/- (20-02-2020)
Pharmacological Group Antibiotic
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 075659; NCO-60
"Each Gm Contains:-
Oxytetracycline Hcl……………...20% W/V
Colistin Sulphate………………...20% W/V
Neomycin……………………….20% W/V
"M/S. Breeze Pharma (Pvt.) Ltd., Kahuta Road, Islamabad."
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator The drug already approved by DRAP (generic / me-too status)
provided by you mentions “Neomycin” whereas, you have
applied for “Neomycin Sulphate".
Decision: Deferred for revision of formulation as per the DRAP approved generic product along
with submission of requisite fee.
150. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Sulpamed-325 W/S Powder
Composition "Each 100g Contains:
Oxytetracycline Hcl…30g
Colistin Sulphate…50MIU
Neomycin Sulphate…25g"
Diary No. Date of R&I &fee Dy.No 2061 dated 20-02-2020 Rs.20,000/- (20-02-2020)
Pharmacological Group Antibiotic
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 073952; Oxyneoriq-C Water Soluble Powder
"Each 1000gm contains:-
Oxytetracycline HCL…300gm
Neomycin Sulphate…..250gm
Colistin Sulphate……500 MIU
"M/s Baariq Pharmaceuticals, Lahore."
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
Minutes of 294th Meeting of Registration Board | 185
151. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Hansflor-F W/S Powder
Composition "Each g Contains:
Oxytetracycline Hcl…300mg
Florfenicol…100mg
Neomycin Sulphate…150mg"
Diary No. Date of R&I &fee Dy.No 2064 dated 20-02-2020 Rs.20,000/- (20-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 097977
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator Ne too coulod not be confirmed.
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic
/ me-too status) alongwith registration number, brand name and name of firm.
152. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Hansflor W/S Powder
Composition "Each 100g Contains:
Oxytetracycline Hcl…300mg
Florfenicol…100mg
Neomycin Sulphate…150mg"
Diary No. Date of R&I &fee Dy.No 2065 dated 20-02-2020 Rs.20,000/- (20-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 097869
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator Ne too coulod not be confirmed.
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic
/ me-too status) alongwith registration number, brand name and name of firm.
153. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Beracin-H W/S Powder
Composition "Each 100g Contains:
Fosfomycin Calcium…….20g
Tylosin Tartrate………….10g
Fructose………………….18g
Sodium Phosphate……….15g
Magnesium Phosphate…...10g
Sodium Chloride qty sufficient to make…100g"
Diary No. Date of R&I &fee Dy.No 2067 dated 20-02-2020 Rs.20,000/- (20-02-2020)
Pharmacological Group Antibacterial, Electrolyte Replenisher
Type of Form Form 5
Minutes of 294th Meeting of Registration Board | 186
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 075626; Fofact Powder
"Each 100gm Contains: -
Calcium Fosfomycin.20gm
Tylosin Tartrate……..5gm
Fructose 1,6 Diphosphate………...18gm
Sodium Phosphate…15gm
Magnesium Phosphate…………..10gm
Sodium Chloride Gs-To………………….100gm
"M/s. Univet Pharmaceuticals, Rawalpindi."
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator The cover letter and composition mentions Tylosin
Tartrate……..5g whereas, Form 5 mentions Tylosin
Tartrate……..10g. Clarification is required with respect to
applied strength.
Decision: Deferred for clarification of applied composition, since different composition is
mentioned on covering letter and form 5.
154. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Beracin W/S Powder
Composition "Each 100g Contains:
Fosfomycin Calcium…….20g
Tylosin Tartrate………….10g
Fructose…………………18g
Sodium Phosphate……….15g
Magnesium Phosphate…..10g"
Diary No. Date of R&I &fee Dy.No 2068 dated 20-02-2020 Rs.20,000/- (20-02-2020)
Pharmacological Group Antibacterial, Electrolyte Replenisher
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 078240; Fosfotyl Powder
"Each 100gm Contains:-
Fosfomycin Calcium ……20gm
Tylosin Tartrate…………10gm
Fructose………………….18gm
Sodium Phosphate ……...15gm
Magnesium Sulphate ..…10 Gm
"M/s. Leads Pharma (Pvt) Ltd., Islamabad."
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator The drug already approved by DRAP (generic / me-too status)
provided by you mentions “Magnesium Sulphate” whereas
applied formulation is Magnesium Phosphate".
Decision: Deferred for revision of formulation as per the DRAP approved generic product along
with submission of requisite fee.
155. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Bem-Cool W/S Powder
Minutes of 294th Meeting of Registration Board | 187
Composition "Each 100g Contains:
Vitamin C……………20g
Aspirin……………….6.7g"
Diary No. Date of R&I &fee Dy.No 2066 dated 20-02-2020 Rs.20,000/- (20-02-2020)
Pharmacological Group Anti-oxidant, Analgesic, Antipyretic
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 049778; Bursa Gold Water Soluble Powder
"Each 100g Contains:-
Acetyl Salicyclic Acid….6.7gm
Vitamin C…………..….20gm
M/s Attabak Pharma, Islamabad
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Registration Board referred the case to expert working group on veterinary drugs for
review of formulation.
156. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Bimbo-H W/S Powder
Composition "Each 100g Powder Contains:
Potassium Citrate…18g
Sodium Citrate…12g
Vitamin B1…0.03g
Vitamin B2…0.015g
Nicotinamide…0.32g
Menadione Bisulfate…0.115g
Vitamin C…1.10g"
Diary No. Date of R&I &fee Dy.No 2069 dated 20-02-2020 Rs.20,000/- (20-02-2020)
Pharmacological Group Vitamin,Mineral
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 046581; Anti Gumbo Powder
"Each 100gm Contains:-
Potassium Citrate ….. 18gm.
Sodium Citrate …….. 12gm.
Vitamin B1…………. 0.03gm.
Vitamin B2…………. 0.015gm.
Nictinamide ……….. 0.32gm.
Menadione Bisulfite…0.115gm.
Vitamin C………….. 1.10gm.
(Vitamin Preparation).
M/s Leads Pharma (Pvt) Ltd., Islamabad
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
157. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Minutes of 294th Meeting of Registration Board | 188
Brand Name +Dosage Form + Strength Bimrol-C W/S Powder
Composition "Each 100g Contains:
Vitamin C…20g
Paracetamol…2g
Potassium Chloride…4g
Calcium Carbonate…4.5g
Magnesium Sulphate…3.5g"
Diary No. Date of R&I &fee Dy.No 2071 dated 20-02-2020 Rs.20,000/- (20-02-2020)
Pharmacological Group Antioxidant, Analgesic, Antipyretic
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 078239; Spin-C Powder
"Each 100gm Contains:-
Paracetamol………….2gm
Vitamin C (Ascorbic Acid)…………….20gm
Calcium Carbonate……..4.5gm
Magnesium Sulphate…...3.5gm
Potassium Chloride……….4gm
"M/s. Leads Pharma (Pvt) Ltd., Islamabad."
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
158. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Broncho-EZ W/S Powder
Composition "Each g Contains:
Doxycycline Hcl…200mg
Tylosin tartrate…100mg
Colistin Sulphate…0.5MIU
Bromhexine Hcl…5mg
Streptomycin Sulphate…20mg"
Diary No. Date of R&I &fee Dy.No 2062 dated 20-02-2020 Rs.20,000/- (20-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 078296; Riz Wan-S Water Soluble Powder
"Each g Contains:-
Doxycycline Hcl………200mg
Tylosin Tartrate………..100mg
Colistin Sulphate……...0.5MIU
Bromhexine Hcl …………5mg
Steptomycin Sulphate……20mg
"M/s. Nawal Pharmaceuticals, Rawalpindi"
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Registration Board referred the case to expert working group on veterinary drugs for
review of formulation.
Minutes of 294th Meeting of Registration Board | 189
159. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Broc-Haans W/S Powder
Composition "Each 1000g Contains:
Doxycycline Hcl…………200g
Tylosin tartrate……………100g
Colistin Sulphate…………450MIU
Bromhexine Hcl………….5g
Streptomycin Sulphate……36g"
Diary No. Date of R&I &fee Dy.No 2063 dated 20-02-2020 Rs.20,000/- (20-02-2020)
Pharmacological Group Antibacterial
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 071069; Pulmodox-S Powder.
"Each 1000gm Contains:-
Tylosine Tartarate 100gm.
Doxycycline Hydrochloride 200gm.
Colistin Sulphate…450MIU.
Bromohexine Hvdrocloride…5gm.
Streptomycin Sulphate…….36gm.
"M/s Attabak Pharmaceutical, Islamabad."
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Registration Board referred the case to expert working group on veterinary drugs for
review of formulation.
160. Name and address of
Manufacturer / Applicant
"M/s D-Haans Pharmaceuticals.
Plot No. 9/A, Industrial Estate, Bhimber"
Brand Name +Dosage Form + Strength Fura-Hans W/S Powder
Composition "Each 1000g Contains:
Furosemide…20g
Manganese Sulphate…1g
Potassium Chloride…4g
Calcium Carbonate…45g
Magnesium Sulphate…35g
Sodium Chloride…35g"
Diary No. Date of R&I &fee Dy.No 2070 dated 20-02-2020 Rs.20,000/- (20-02-2020)
Pharmacological Group Diuretic, Electrolyte Supplement.
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 100g, 250g, 500g,1Kg,5Kg,10kg
Me-too status 078265; F-Maars Water Soluble Powder
"Each 1000g Contains:-
Furosemide………………...20g
Potassium Chloride…………4g
Calcium Carbonate………...45g
Manganese Sulphate ………..1g
Sodium Chloride………..…35g
Magnesium Sulphate………35g
"M/S. D-Maarson Pharmaceuticals, Rawat, Islamabad."
GMP status CLB in its 273rd meeting held on 15th Jan, 2020 considered the
case of M/s D-Haans Pharmaceuticals.Plot No. 9/A, Industrial
Minutes of 294th Meeting of Registration Board | 190
Estate, Bhimber Pakistan and approved the grant of DML by
way of formulation with following four sections.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
Item No. 7: Agenda of Evaluator PEC-VI
Case no. 02 Registration applications of newly granted DML or New section (Human)
a. New DML
CLB in its 270th meeting held on 23rd may, 2019 has considered & approved the grant of DML of M/s
Healthcare Pharnaceuticals by the way of formulation with following 8 sections:
1. Tablet section (general)
2. Capsule section (general)
3. Sachet section (general)
4. Dry suspension section (general)
5. Cream and ointment (general) section
6. Oral liquid syrup/suspension(general) section
7. External application
8. Liquid repacking section.
Now the applicant has applied for following molecules/products against each section:
Extension in implementation timelines of SRO 713(I)/2018
The Authority in its 72nd meeting discussed regarding the “Extension in implementation timelines of SRO
713(I)/2018 and decided as follows:-
1. Allowed those companies, for which panel for inspection has been constituted before 07-03-2019, to
submit registration applications on Form 5 instead of Form 5F for initial 10 molecules per section only.
2. The exemption will remain valid till 31-12-2019.
3. No further exemption will be granted in any case.
4. Inspectors / panel members are advised to formally report every visit. Concerned Division was advised to
specify a timelines for conducting/ concluding panel inspection.
a) Details of issuance of DML are as follow: Name of Firm Date of issuance of
panel inspection letter
Date of issuance
of DML
Date of Submission
of applications
M/s Healthcare Pharmaceuticals
Multan
31st January 2019 28th June 2019 November &
December 2019
M/s KBR Pharmaceuticals, Hattar 8th March 2018 28th June 2019 November 2019
The submission of following applications on foirm-5 are in line with the decision of Authority
Capsule (general): 10Molecules; 20Products;
161. Name and address of manufacturer /
Applicant
M/S Health Care Pharmaceuticals 40-Km,Lahore Road Multan
Brand Name +Dosage Form + Strength Dolin 100mg Capsule
Composition Each Capsule contains:
Doxycycline Hyclate eq.to
Doxycycline……..100mg
Diary No. Date of R& I & fee Dy.No. 24696 ;(22-11-2019);Rs.20,000/-( 19-11-2019)
Pharmacological Group Antibiotic (Tetracyclines)
Type of Form Form-5
Finished product Specification BP
Pack size & Demanded Price 10x10’s; As fixed by MoH
Approval status of product in
Reference Regulatory Authorities.
MHRA Approved
Me-too status Dok-C-M Capsule 100mg of M/s Mediate Pharmaceuticals
GMP status New DML 000905 28/06/2019
Evaluation by PEC
Decision: Approved.
Minutes of 294th Meeting of Registration Board | 191
162. Name and address of manufacturer /
Applicant
M/S Health Care Pharmaceuticals 40-Km, Lahore Road Multan
Brand Name +Dosage Form + Strength DENSO 60 mg Capsule
Composition Each Capsule contains:
Dual Delayed Release dexlansoprazole pellets eq to
Dexlansoprazole ….………..60mg
Diary No. Date of R& I & fee Dy.No. 24694 ;(22-11-2019);Rs.20,000/-(19-11-2019)
Pharmacological Group Proton Pump inhibitor
Type of Form Form -5
Finished product Specification (Manufacturers specifications)
Pack size & Demanded Price As per SRO
Approval status of product in
Reference Regulatory Authorities.
Dexilant Delayed Release Capsule 30mg of USFDA approved
Me-too status Lansodex Capsule 30mg of M/S Getz Pharma
GMP status New DML 000905 28/06/2019
Evaluation by PEC Stability studies and other relevant documents are not provided.
Decision: Registration Board deferred the case for submission of stability study data as per the
guidelines provided in 278th and 293rd meeting of Registration Board.
163. Name and address of manufacturer /
Applicant
DENSO 30mg Capsule
Brand Name +Dosage Form + Strength Each Capsule contains:
Dual Delayed Release dexlansoprazole pellets eq to
Dexlansoprazole ….………..30mg
Composition Dy.No. 24693; (22-11-2019); Rs.20,000/
Diary No. Date of R& I & fee Proton Pump inhibitor
Pharmacological Group Form -5
Type of Form (Manufacturers specifications)
Finished product Specification As per SRO
Pack size & Demanded Price Dexilant Delayed Release Capsule 30mg of USFDA approved
Approval status of product in
Reference Regulatory Authorities.
Lansodex Capsule 30mg of M/S Getz Pharma
Me-too status New DML 000905 28/06/2019
GMP status DENSO 30mg Capsule
Evaluation by PEC Stability studies and other relevant documents are not provided.
Decision: Registration Board deferred the case for submission of stability study data as per the
guidelines provided in 278th and 293rd meeting of Registration Board.
164. Name and address of manufacturer /
Applicant
M/S Health Care Pharmaceuticals 40-Km,Lahore Road Multan
Brand Name +Dosage Form + Strength LOXETIN 20mg Capsule
Composition Each capsule contains: - Enteric coated pellets of Duloxetine HCl
eq. to Duloxetine…………..20mg
Diary No. Date of R& I & fee Dy.No.26390 ;( 09-12-2019);Rs.20,000
Pharmacological Group Antipsychotic
Type of Form Form -5
Finished product Specification USP
Pack size & Demanded Price As per SRO
Approval status of product in
Reference Regulatory Authorities.
Duloxetine 30 mg gastro-resistant capsules By Tillomed
Laboratories Ltd. (PL: 11311/0554) MHRA Approved.
Me-too status SYMPTA Capsules Polyfine Chempharma (Pvt,) Ltd. Peshawar
GMP status New License (DML 000905) (Inspection Date: 28/06/2019)
Evaluation by PEC Pellets details are not provided.
Decision: Deferred for source of pellets, along with stability studies data, GMP certificate of
supplier and differential fee in case of import of pellets.
Minutes of 294th Meeting of Registration Board | 192
165. Name and address of manufacturer /
Applicant
M/S Health Care Pharmaceuticals 40-Km,Lahore Road Multan
Brand Name +Dosage Form + Strength LOXETIN 30mg Capsule
Composition Each capsule contains: - Enteric coated pellets of Duloxetine HCl
eq. to Duloxetine…….….…………..30mg
Diary No. Date of R& I & fee Dy.No. 26391 ;( 09-12-2019);Rs.20,000/-
Pharmacological Group Antipsychotic
Type of Form Form -5
Finished product Specification USP
Pack size & Demanded Price As per SRO
Approval status of product in
Reference Regulatory Authorities.
Duloxetine 30 mg gastro-resistant capsules By Tillomed
Laboratories Ltd. (PL: 11311/0554) MHRA Approved.
Me-too status SYMPTA Capsules Polyfine Chempharma (Pvt,) Ltd. Peshawar
(Reg.# 078462)
GMP status New License (DML 000905) (Inspection Date: 28/06/2019)
Evaluation by PEC Pellets details are not provided.
Decision: Deferred for source of pellets, along with stability studies data, GMP certificate of
supplier and differential fee in case of import of pellets.
166. Name and address of manufacturer /
Applicant
M/S Health Care Pharmaceuticals 40-Km,Lahore Road Multan
Brand Name +Dosage Form + Strength LEXO 60mg Capsule
Composition Each Capsule contains:
Fexofenadine HCl……....60mg
Diary No. Date of R& I & fee Dy.No. 26392 ;( 09-12-2019);Rs.20,000/-
Pharmacological Group Antihistamine
Type of Form Form -5
Finished product Specification USP
Pack size & Demanded Price 10‘s and 20‘s; As per PRC
Approval status of product in
Reference Regulatory Authorities.
Could not be confirmed
Me-too status Exo Capsule English Pharmaceuticals
GMP status New License (DML 000905) (Inspection Date: 28/06/2019)
Evaluation by PEC Reference product could not be confirmed
Decision: Deferred for evidence of approval of applied formulation in reference regulatory
authorities / agencies which were adopted by the Registration Board in its 275th meeting.
167. Name and address of manufacturer /
Applicant
M/S Health Care Pharmaceuticals 40-Km,Lahore Road Multan
Brand Name +Dosage Form + Strength LEXO 120mg Capsule
Composition Each Capsule contains:
Fexofenadine HCl……....120mg
Diary No. Date of R& I & fee Dy.No.26400 ;( 09-12-2019);Rs.20,000/-
Pharmacological Group Antihistamine
Type of Form Form -5
Finished product Specification USP
Pack size & Demanded Price 10‘s and 20‘s; As per PRC
Approval status of product in
Reference Regulatory Authorities.
Could not be confirmed
Me-too status Exo Capsule English Pharmaceuticals
GMP status New License (DML 000905) (Inspection Date: 28/06/2019)
Evaluation by PEC Reference product could not be confirmed
Decision: Deferred for evidence of approval of applied formulation in reference regulatory
authorities / agencies which were adopted by the Registration Board in its 275th meeting.
Minutes of 294th Meeting of Registration Board | 193
168. Name and address of manufacturer /
Applicant
M/S Health Care Pharmaceuticals 40-Km,Lahore Road Multan
Brand Name +Dosage Form + Strength LEXO 180mg Capsule
Composition Each Capsule contains:
Fexofenadine HCl……....180mg
Diary No. Date of R& I & fee Dy.No. 26402 ;( 09-12-2019);Rs.20,000/-
Pharmacological Group Antihistamine
Type of Form Form -5
Finished product Specification USP
Pack size & Demanded Price 10‘s and 20‘s; As per PRC
Approval status of product in
Reference Regulatory Authorities.
Could not be confirmed
Me-too status Exo Capsule English Pharmaceuticals
GMP status New License (DML 000905) (Inspection Date: 28/06/2019)
Evaluation by PEC Reference product could not be confirmed
Decision: Deferred for evidence of approval of applied formulation in reference regulatory
authorities / agencies which were adopted by the Registration Board in its 275th meeting.
169. Name and address of manufacturer /
Applicant
M/S Health Care Pharmaceuticals 40-Km,Lahore Road Multan
Brand Name +Dosage Form + Strength CLOFEN 50mg CAPSULES
Composition Each Capsule Contains:
SR pellets of diclofenac sodium ……….50mg
Source of Pellets: Vision pharmaceuticals
Diary No. Date of R& I & fee Dy.No. 23167 ;07 -11-2019; Rs.20,000
Pharmacological Group Antiinflammatory and antirheumatic products, non-steroids
(Acetic acid derivatives and related substances)
Type of Form Form 5
Finished product Specification Mfg
Pack size & Demanded Price 2 x 10‘s: As per SRO
Approval status of product in
Reference Regulatory Authorities.
DIFENE Ireland Approved.
Me-too status 071688; Hegen-50 Capsules, Healers Pharma, Peshawar.
GMP status New License (DML 000905) (Inspection Date: 28/06/2019)
Evaluation by PEC
Decision: Approved with BP specification.
170. Name and address of manufacturer /
Applicant
M/S Health Care Pharmaceuticals 40-Km,Lahore Road Multan
Brand Name +Dosage Form + Strength CLOFEN SR 100mg CAPSULES
Composition Each Capsule Contains:
SR pellets of diclofenac sodium ……….100mg
Source of Pellets: Vision pharmaceuticals
Diary No. Date of R& I & fee Dy.No.23168 ;07 -11-2019; Rs.20,000
Pharmacological Group Antiinflammatory and antirheumatic products, non-steroids
(Acetic acid derivatives and related substances)
Type of Form Form 5
Finished product Specification Mfg
Pack size & Demanded Price 2 x 10‘s: As per SRO
Approval status of product in
Reference Regulatory Authorities.
Rhumalgan XL100 mg Modified-Release Capsules MHRA
Approved
Me-too status Phlogen capsule 100mg by Brookes
GMP status New License (DML 000905) (Inspection Date: 28/06/2019)
Evaluation by PEC
Decision: Approved with BP specification.
Minutes of 294th Meeting of Registration Board | 194
171. Name and address of manufacturer /
Applicant
M/S Health Care Pharmaceuticals 40-Km,Lahore Road Multan
Brand Name +Dosage Form + Strength Amadole 100mg Capsule
Composition Each Capsule Contains:
Tramadol HCl…100mg
Diary No. Date of R& I & fee Dy.No.23153 ;07 -11-2019; Rs.20,000
Pharmacological Group Opioid Analgesi
Type of Form Form 5
Finished product Specification BP
Pack size & Demanded Price As per SRO
Approval status of product in
Reference Regulatory Authorities.
Tramadol 50mg capsule by Milpharm Ltd, approved by MHRA
of UK.
Me-too status Tramal capsule 100mg by Impex Plus Karachi
GMP status New License (DML 000905) (Inspection Date: 28/06/2019)
Evaluation by PEC
Decision: Approved.
172. Name and address of manufacturer /
Applicant
M/S Health Care Pharmaceuticals 40-Km,Lahore Road Multan
Brand Name +Dosage Form + Strength Opezole 20mg Capsule
Composition Each capsule contains:
Enteric coated pallets of Omeprazole eq. to Omeprazole ….20mg
Diary No. Date of R& I & fee Dy.No23150 ;07 -11-2019; Rs.20,000
Pharmacological Group Proton Pump Inhibitor
Type of Form Form 5
Finished product Specification USP
Pack size & Demanded Price 10‘s, 14‘s & 100‘s/As per DPC
Approval status of product in
Reference Regulatory Authorities.
OMEPRAZOLE 20 mg GASTRO-RESISTANT CAPSULES of
M/s DEXCEL-PHARMA LIMITED UK
Me-too status Alomep 20mg Capsule of M/s Alson
GMP status New License (DML 000905) (Inspection Date: 28/06/2019)
Evaluation by PEC Pellets detail are not provided
Decision: Deferred for source of pellets, along with stability studies data, GMP certificate of
supplier and differential fee in case of import of pellets.
173. Name and address of manufacturer /
Applicant
M/S Health Care Pharmaceuticals 40-Km,Lahore Road Multan
Brand Name +Dosage Form + Strength Opezole 40mg Capsule
Composition Each capsule contains: Enteric coated pallets of Omeprazole eq.
to Omeprazole ….40mg
Diary No. Date of R& I & fee Dy.No. 23151;07-11-2019; Rs.20,000
Pharmacological Group Proton Pump Inhibitor
Type of Form Form 5
Finished product Specification USP
Pack size & Demanded Price 10‘s, 14‘s & 100‘s/As per DPC
Approval status of product in
Reference Regulatory Authorities.
OMEPRAZOLE 40 mg GASTRO-RESISTANT CAPSULES of
M/s DEXCEL-PHARMA LIMITED UK
Me-too status Alomep 40mg Capsule of M/s Alson
GMP status New License (DML 000905) (Inspection Date: 28/06/2019)
Evaluation by PEC Pellets detail are not provided
Decision: Deferred for source of pellets, along with stability studies data, GMP certificate of
supplier and differential fee in case of import of pellets.
174. Name and address of manufacturer /
Applicant
M/S Health Care Pharmaceuticals 40-Km,Lahore Road Multan
Brand Name +Dosage Form + Strength Amadole 50mg Capsule
Minutes of 294th Meeting of Registration Board | 195
Composition Each Capsule Contains:
Tramadol HCl…50mg
Diary No. Date of R& I & fee Dy.No.23152 ;07 -11-2019; Rs.20,000
Pharmacological Group Opioid Analgesi
Type of Form Form 5
Finished product Specification BP
Pack size & Demanded Price As per SRO
Approval status of product in
Reference Regulatory Authorities.
Adolonta 50 mg hard capsules by Grünenthal Pharma, SA
(Spain Approved)
Me-too status Tramal capsule 50mg by Impex Plus Karachi (Reg#010170)
GMP status New License (DML 000905) (Inspection Date: 28/06/2019)
Evaluation by PEC
Decision: Approved.
175. Name and address of manufacturer /
Applicant
M/S Health Care Pharmaceuticals 40-Km,Lahore Road Multan
Brand Name +Dosage Form + Strength Flunaz 150mg Capsule
Composition Each Capsule Contains:
Fluconazole…150mg
Diary No. Date of R& I & fee Dy.No.23145 ;07 -11-2019; Rs.20,000
Pharmacological Group Antimycotics for systemic use
Type of Form Form 5
Finished product Specification BP
Pack size & Demanded Price 1‘s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Fluconazole 150mg capsule by Bristol Laboratories MHRA
Approved
Me-too status Fungon Capsules 150mg by Dyson Research Lab.(R.#055353)
GMP status New License (DML 000905) (Inspection Date: 28/06/2019)
Evaluation by PEC
Decision: Approved.
176. Name and address of manufacturer /
Applicant
M/S Health Care Pharmaceuticals 40-Km,Lahore Road Multan
Brand Name +Dosage Form + Strength Esopra 40mg Capsule
Composition Each capsule enteric-coated pellets contains:
Esomeprazole as Magnesium Dihydrate…….40m
Diary No. Date of R& I & fee Dy.No.23144 ;07 -11-2019; Rs.20,000
Pharmacological Group Proton Pump Inhibitor
Type of Form Form 5
Finished product Specification USP
Pack size & Demanded Price 14‘s & Rs. 323/- per 14 capsules
Approval status of product in
Reference Regulatory Authorities.
MHRA Approved
Me-too status Ulcicare 40mg capsules of M/s Jawa Pharma (Reg. # 050300)
GMP status New License (DML 000905) (Inspection Date: 28/06/2019)
Evaluation by PEC Pellets details are not provided
Decision: Deferred for source of pellets, along with stability studies data, GMP certificate of
supplier and differential fee in case of import of pellets.
177. Name and address of manufacturer /
Applicant
M/S Health Care Pharmaceuticals 40-Km,Lahore Road Multan
Brand Name +Dosage Form + Strength Esopra 20mg Capsule
Composition Each capsule enteric- coated pellets contains: Esomeprazole as
Magnesium Dihydrate…….20mg
Diary No. Date of R& I & fee Dy.No. 23143 ;07 -11-2019; Rs.20,000
Pharmacological Group Proton Pump Inhibitor
Type of Form Form 5
Minutes of 294th Meeting of Registration Board | 196
Finished product Specification USP
Pack size & Demanded Price 14‘s & Rs. 170/- per 14 capsules
Approval status of product in
Reference Regulatory Authorities.
MHRA Approved
Me-too status Esante 20mg capsules of M/s Macter International (Reg. #
050576)
GMP status New License (DML 000905) (Inspection Date: 28/06/2019)
Evaluation by PEC Pellets details are not provided
Decision: Deferred for source of pellets, along with stability studies data, GMP certificate of
supplier and differential fee in case of import of pellets.
178. Name and address of manufacturer /
Applicant
M/S Health Care Pharmaceuticals 40-Km,Lahore Road Multan
Brand Name +Dosage Form + Strength Azithrocare 250mg Capsule
Composition Each Capsule Contains:
Azithromycin As Dihydrate………………..250mg
Diary No. Date of R& I & fee Dy.No.23137 ;07 -11-2019; Rs.20,000
Pharmacological Group Macrolide
Type of Form Form 5
Finished product Specification USP
Pack size & Demanded Price 10‘S, 20‘S & 30‘S; As Per Prc
Approval status of product in
Reference Regulatory Authorities.
TGA Approved
Me-too status Arcin 250 Mg Capsule Linear Pharma
GMP status New License (DML 000905) (Inspection Date: 28/06/2019)
Evaluation by PEC
Decision: Approved.
179. Name and address of manufacturer /
Applicant
M/S Health Care Pharmaceuticals 40-Km,Lahore Road Multan
Brand Name +Dosage Form + Strength Dolin 50mg Capsule
Composition Doxycycline Hyclate eq. to Doxycycline……..50mg
Diary No. Date of R& I & fee Dy.No. 24695 ;(22-11-2019);Rs.20,000/
Pharmacological Group Antibiotic (Tetracyclines)
Type of Form Form-5
Finished product Specification BP
Pack size & Demanded Price 10x10’s; As fixed by MoH
Approval status of product in
Reference Regulatory Authorities.
USFDA Approved
Me-too status Dok-C-M Capsule 50mg of M/s Mediate Pharmaceuticals
GMP status New DML 000905 28/06/2019
Evaluation by PEC
Decision: Approved.
180. Name and address of manufacturer /
Applicant
M/S Health Care Pharmaceuticals 40-Km,Lahore Road Multan
Brand Name +Dosage Form + Strength LOXETIN 60mg Capsule
Composition Each capsule contains: -
Enteric coated pellets of Duloxetine HCl eq. to
Duloxetine…….….…………..60mg
Diary No. Date of R& I & fee Dy.No.26392 ;( 09-12-2019);Rs.20,000/-
Pharmacological Group Antipsychotic
Type of Form Form -5
Minutes of 294th Meeting of Registration Board | 197
Finished product Specification USP
Pack size & Demanded Price As per SRO
Approval status of product in
Reference Regulatory Authorities.
Duloxetine 60 mg gastro-resistant capsules By Tillomed
Laboratories Ltd. (PL: 11311/0554) MHRA Approved.
Me-too status SYMPTA Capsules Polyfine Chempharma (Pvt,) Ltd. Peshawar
GMP status New License (DML 000905) (Inspection Date: 28/06/2019)
Evaluation by PEC Pellets details are not provided.
Decision: Deferred for source of pellets, along with stability studies data, GMP certificate of
supplier and differential fee in case of import of pellets.
M/s. KBR Pharmaceuticals, Plot # 123 - B, Phase V, Industrial Estate, Hattar.
Following registration dossiers have been received vide letter No. dated 07/03/ 2019 stating that the firm
has been granted approval of new DML by way of formulation by Central Licensing Board in its 269th
meeting for following eight (8)sections
1. Capsule Section (General)
2. Dry powder Suspension Section (General)
3. Cream/Ointment/Gel Section
4. Sachet Section (General)
5. Liquid Injection Section (General)
6. Capsule Section (Cephalosporin)
7. Dry Powder Suspension Section (Cephalosporin)
8. Dry powder injection (Cephalosporin)
Capsule Section (General) 24 products/ 10 molecules
181. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Ribek Capsule 20 mg
Diary No. Date of R& I & fee Diary No: 23181 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each capsule contains:
Omeprazole (as enteric coated pellets)…..20mg
Source: Vision Pharmaceuticals
Pharmacological Group Proton pump Inhibitor
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 7, 10,14 & 100’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Prilosec 20 mg Capsule by M/s Dr. Reddy’s Laboratories UK
Me-too status Ompiget 20 mg Capsule by M/s Novae Pharmaceuticals
Anzo 20 mg Capsule by Searle Pakistan
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
182. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Ribek Capsule 40 mg
Diary No. Date of R& I & fee Diary No:23182 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each capsule contains:
Omeprazole (as enteric coated pellets)…..40mg
Source: Vision Pharmaceuticals
Pharmacological Group Proton pump Inhibitor
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 7, 10,14 & 100’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Prilosec 40 mg Capsule by M/s Dr. Reddy’s Laboratories UK
Minutes of 294th Meeting of Registration Board | 198
Me-too status Ompiget 40 mg Capsule by M/s Novae Pharmaceuticals
Anzo 40 mg Capsule by Searle Pakistan
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
183. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Ribek S Capsule 20 mg /1100 mg
Diary No. Date of R& I & fee Diary No: 23183 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition "Each capsule contains:
Omeprazole…20 mg
Sodium bicarbonate…1100 mg"
Pharmacological Group Proton pump Inhibitor / Ant Acid
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 7, 10,14, 20 & 30’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
ZEGERID Capsule /Approved in US-FDA
Me-too status MEP – B CAPSULE by Genix Pharma
Omega Capsule by Ferozsons laboratories limited.
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
184. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Ribek Plus Capsule 40 mg/ 1100 mg
Diary No. Date of R& I & fee Diary No: 23180 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition "Each capsule contains:
Omeprazole…40 mg
Sodium bicarbonate…1100 mg"
Pharmacological Group Proton pump Inhibitor / Ant Acid
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 7, 10,14, 20 & 30’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
ZEGERID Capsule /Approved in US-FDA
Me-too status MEP – B CAPSULE by Genix Pharma
Omega Capsule by Ferozsons laboratories limited.
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
185. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Rexim Capsule 20 mg
Diary No. Date of R& I & fee Diary No: 23172 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each capsule contains:
Esomeprazole (as enteric coated pellets)…..20mg
Source: Vision Pharmaceuticals
Pharmacological Group Proton pump Inhibitor
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 7, 10,14 & 100’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Nexium 20mg Capsule by AstraZeneca Pharmaceuticals
US
Minutes of 294th Meeting of Registration Board | 199
Me-too status Essonave 20 mg Capsule by M/s Novae Pharmaceuticals
Esso 20 mg Capsule by Shaigan Pharmaceuticals
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
186. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Rexim Capsule 40 mg
Diary No. Date of R& I & fee Diary No: 23173 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each capsule contains:
Esomeprazole (as enteric coated pellets)…..40mg
Source: Vision Pharmaceuticals
Pharmacological Group Proton pump Inhibitor
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 7, 10,14 & 100’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Nexium 40mg Capsule by AstraZeneca Pharmaceuticals
US
Me-too status Essonave 40 mg Capsule by M/s Novae Pharmaceuticals
Esso 40 mg Capsule by Shaigan Pharmaceuticals
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
187. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Racobac Capsule 250 mg
Diary No. Date of R& I & fee Diary No: 23174 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each capsule contains:
Azithromycin as Dihydrate……250mg
Pharmacological Group Macrolide Antibiotic
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 6‘s,10‘s; As per SRO
Approval status of product in
Reference Regulatory Authorities.
MHRA Approved
Me-too status Navozith 250 mg Capsule by M/s Novae Pharmaceuticals
Azomax 250 mg Capsule by Sandoz Pakistan
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
188. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Riflucan Capsule 50 mg
Diary No. Date of R& I & fee Diary No: 23179 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each capsule contains:
Fluconazole…..50mg
Pharmacological Group Anti Fungal
Type of Form Form-5
Finished Product Specification BP
Pack size & Demanded Price 1, 4, 5, 7 & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
MHRA Approved
Me-too status Fluderm 50 mg Capsule by M/s Nabi Qasim Industries
Fugix 50 mg Capsule by Helix Pharma
Minutes of 294th Meeting of Registration Board | 200
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
189. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Riflucan Capsule 150 mg
Diary No. Date of R& I & fee Diary No: 23178 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each capsule contains:
Fluconazole…..150mg
Pharmacological Group Anti Fungal
Type of Form Form-5
Finished Product Specification BP Specs
Pack size & Demanded Price 1, 4, 5, 7 & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
MHRA Approved
Me-too status Axicon 150 mg Capsule by M/s Axis Pharma
Candia 150 mg Capsule by Fynk Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
190. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Riflucan Capsule 200 mg
Diary No. Date of R& I & fee Diary No: 23177 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each capsule contains:
Fluconazole…..200mg
Pharmacological Group Anti Fungal
Type of Form Form-5
Finished Product Specification BP
Pack size & Demanded Price 1, 4, 5, 7 & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
MHRA Approved
Me-too status Mycol 200 mg Capsule by M/s Nex Pharma
Fcozole 200 mg Capsule by MediCraft Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
191. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Reldene Capsule 20 mg
Diary No. Date of R& I & fee Diary No: 23195 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each capsule contains:
Piroxicam…..20 mg
Pharmacological Group NSAID
Type of Form Form-5
Finished Product Specification Mfg Specs
Pack size & Demanded Price 10,20 & 30’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Feldene 20 mg Capsules by Pfizer (USFDA approved)
Me-too status Axicam 20 mg Capsule by M/s Mas Pharmaceuticals
Biocam 20 mg Capsule by Biorax Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator. Complete salt name is not written
Minutes of 294th Meeting of Registration Board | 201
Decision: Deferred for revision of formulation including salt form as per reference product along
with submission of requisite fee.
192. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Rhlogin Capsule 50 mg
Diary No. Date of R& I & fee Diary No: 23175 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each capsule contains:
Diclofenac Sodium (as SR pellets)…..50mg
Source: Vision Pharmaceuticals
Pharmacological Group NSAID
Type of Form Form-5
Finished Product Specification Mfg
Pack size & Demanded Price 10, 20 & 30’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
DIFENE Ireland Approved.
Me-too status Amfac 50mg Capsules by M/S Ambrosia Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved with BP specifications.
193. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Rhlogin Capsule 75 mg
Diary No. Date of R& I & fee Diary No: 23176 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each capsule contains:
Diclofenac Sodium (as SR pellets)…..75mg
Source: Vision Pharmaceuticals
Pharmacological Group NSAID
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 10, 20 & 30’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
MHRA Approved
Me-too status Fenal 75mg Capsules by M/S Alson Pharma
Zwitter 75 mg Capsules by Willshire Labs
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved with BP specifications.
194. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Rhlogin Capsule 100 mg
Diary No. Date of R& I & fee Diary No: 23193 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each capsule contains:
Diclofenac Sodium (as SR pellets)…..100 mg
Source: Vision Pharmaceuticals
Pharmacological Group NSAID
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 10, 20 & 30’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Rhumalgan XL100 mg Modified-Release Capsules MHRA
Approved
Me-too status Anifen 100 mg Capsules by M/S Medera Pharma
Dycnom 100 mg Capsules by M/S Genome Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Minutes of 294th Meeting of Registration Board | 202
Decision: Approved with BP specifications.
195. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Ransamin Capsule 250 mg
Diary No. Date of R& I & fee Diary No: 23194 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each capsule contains:
Tranexamic Acid…..250 mg
Pharmacological Group Antifibrinolytics
Type of Form Form-5
Finished Product Specification JP
Pack size & Demanded Price 10, 20, 30 & 100’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
TOWA 250 mg Capsules by M/S Towa Pharmaceuticals Japan
Me-too status BRINO 250 mg Capsules by M/S Sami Pharma
BTROL 250 mg Capsule by M/S Bosch Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
196. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Ransamin Capsule 500 mg
Diary No. Date of R& I & fee Diary No: 23192 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each capsule contains:
Tranexamic Acid…..500 mg
Pharmacological Group Antifibrinolytics
Type of Form Form-5
Finished Product Specification JP
Pack size & Demanded Price 10, 20, 30 & 100’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Tranex 500mg Capsule (AIFA Italy Approved)
Me-too status BRINO 500 mg Capsules by M/S Sami Pharma
BTROL 500 mg Capsule by M/S Bosch Pharma
GMP status
Remarks of the Evaluator. Reference product could not be confirmed
Decision: Approved.
197. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Rylica Capsule 50 mg
Diary No. Date of R& I & fee Diary No: 23184 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each capsule contains:
Pregabalin…….50mg
Pharmacological Group Anticonvulsants
Type of Form Form-5
Finished Product Specification MfgSpecs
Pack size & Demanded Price 7, 14 & 28’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Alzain 50 mg Capsules, Hard. MHRA approved
Me-too status Hilin 50 mg Capsule by Highnoon Pharma
Zeegap 50 mg Capsule by Hilton Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved with innovator’s specification.
Minutes of 294th Meeting of Registration Board | 203
198. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Rylica Capsule 75 mg
Diary No. Date of R& I & fee Diary No: 23185 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each capsule contains:
Pregabalin…….75mg
Pharmacological Group Anticonvulsants
Type of Form Form-5
Finished Product Specification MfgSpecs
Pack size & Demanded Price 7, 14 & 28’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Alzain 75 mg Capsules, Hard. MHRA approved
Me-too status Hilin 75 mg Capsule by Highnoon Pharma
Zeegap 75 mg Capsule by Hilton Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved with innovator’s specification.
199. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Rylica Capsule 100 mg
Diary No. Date of R& I & fee Diary No: 23191, 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each capsule contains:
Pregabalin…….100mg
Pharmacological Group Anticonvulsants
Type of Form Form-5
Finished Product Specification Mfg
Pack size & Demanded Price 7, 14 & 28’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Alzain 100 mg Capsules, Hard. MHRA approved
Me-too status Hilin 100 mg Capsule by Highnoon Pharma
Zeegap 100 mg Capsule by Hilton Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved with innovator’s specification.
200. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Rylica Capsule 150 mg
Diary No. Date of R& I & fee Diary No: 23190 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each capsule contains:
Pregabalin…….150mg
Pharmacological Group Anticonvulsants
Type of Form Form-5
Finished Product Specification Mfg
Pack size & Demanded Price 7, 14 & 28’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Alzain 150 mg Capsules, Hard. MHRA approved
Me-too status Hilin 150 mg Capsule by Highnoon Pharma
Zeegap 150 mg Capsule by Hilton Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved with innovator’s specification.
Minutes of 294th Meeting of Registration Board | 204
201. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Rylica Capsule 200 mg
Diary No. Date of R& I & fee Diary No: 23189 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each capsule contains:
Pregabalin…….200mg
Pharmacological Group Anticonvulsants
Type of Form Form-5
Finished Product Specification Mfg
Pack size & Demanded Price 7, 14 & 28’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Lyrica 200 mg Capsules by Pfizer
Me-too status XAAR 200 mg Capsule by Wilshire Labs
Sigab 200 mg Capsule by Atco Labs
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved with innovator’s specification.
202. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Rylica Capsule 300 mg
Diary No. Date of R& I & fee Diary No: 23188 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each capsule contains:
Pregabalin…….300mg
Pharmacological Group Anticonvulsants
Type of Form Form-5
Finished Product Specification Mfg
Pack size & Demanded Price 7, 14 & 28’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Lyrica 300 mg Capsules by Pfizer
Me-too status Hilin 300 mg Capsule by Highnoon Pharma
Zeegap 300 mg Capsule by Hilton Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved with innovator’s specification.
203. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Relbax Capsule 100 mg
Diary No. Date of R& I & fee Diary No: 23187 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each capsule contains:
Celecoxib .............….100mg
Pharmacological Group NSAID
Type of Form Form-5
Finished Product Specification Mfg Specs
Pack size & Demanded Price 10, 20 & 30’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Celebrex 100mg capsule of M/s Pfizer Limited (MHRA
Approved)
Me-too status Celexx 100mg Capsules by M/S GETZ Pharma.
Celetab 100mg Capsules by M/S INDUS Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved with innovator’s specification.
204. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Relbax Capsule 200 mg
Minutes of 294th Meeting of Registration Board | 205
Diary No. Date of R& I & fee Diary No: 23186 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each capsule contains:
Celecoxib .............….200mg
Pharmacological Group NSAID
Type of Form Form-5
Finished Product Specification Mfg Specs
Pack size & Demanded Price 10, 20 & 30’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Celebrex 100mg capsule of M/s Pfizer Ltd (MHRA Approved)
Me-too status Celexx 200mg Capsules by M/S GETZ Pharma.
Celetab 200mg Capsules by M/S INDUS Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved with innovator’s specification.
Liquid Injection Section (General) 11 products/ 10 molecules
205. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Roltval N Injection (IM/IV) 75mg + 20mg/2 mL
Diary No. Date of R& I & fee Diary No: 23199 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each 2 mL Ampoule Contains:
Diclofenac sodium…….…75mg
Lidocaine HCl…….20mg
Pharmacological Group NSAID & Local Anesthesia
Type of Form Form-5
Finished Product Specification Manufacturer’s specs
Pack size & Demanded Price 2 mL x 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Could not be confirmed
Me-too status Diclotal 2 mL Injection by M/s Berlex labs, Multan
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator. Reference product could not be confirmed
Decision: Deferred for evidence of approval of applied formulation in reference regulatory
authorities / agencies which were adopted by the Registration Board in its 275th meeting.
206. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Roltval Injection (IM/IV) 75mg/3 mL
Diary No. Date of R& I & fee Diary No: 23171 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each 3 mL Ampoule Contains:
Diclofenac sodium…….…75mg
Pharmacological Group NSAID
Type of Form Form-5
Finished Product Specification Manufacturer’s specs
Pack size & Demanded Price 3 mL x 5’s, 10’s & 100’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Could not be confirmed
Me-too status Defnac 3 mL Injection by M/s Searle
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator. Reference product could not be confirmed
Decision: Deferred for evidence of approval of applied formulation in reference regulatory
authorities / agencies which were adopted by the Registration Board in its 275th meeting.
207. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Rindrop Injection (IM/IV) 5mg / mL
Minutes of 294th Meeting of Registration Board | 206
Diary No. Date of R& I & fee Diary No: 23202 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each mL Ampoule Contains:
Vitamin D3 ………. 5 mg
Pharmacological Group Vitamin D Analogue
Type of Form Form-5
Finished Product Specification Mfg
Pack size & Demanded Price 1 mL x 1’s & 5’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Vitamin D3 Bon Injection (ANSM France Approved)
Me-too status D . Drop 5 mg/mL Injection by M/s Ipram Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved with innovator’s specification.
208. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Rethycobal Injection (IM/IV) 500 mcg / mL
Diary No. Date of R& I & fee Diary No: 23203 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each mL Ampoule Contains:
Mecobalamin ………. 500 mcg
Pharmacological Group Vitamin B 12 Analogue
Type of Form Form-5
Finished Product Specification Mfg
Pack size & Demanded Price 1 mL x 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Mecobalamin Injection 500 mcg (PMDA Japan Approved)
Me-too status Cobolmin 500 mcg/mL Injection by M/s Macter Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved with innovator’s specification.
209. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Revofer Injection (IV) 100 mg / 5mL
Diary No. Date of R& I & fee Diary No: 23204 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each 5mL Ampoule Contains:
Iron Sucrose ………. 100 mg
Pharmacological Group Haematenic
Type of Form Form-5
Finished Product Specification USP specs
Pack size & Demanded Price 5 mL x 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Venofer 100 mg / 5ml Injection By Vifor Pharma
Me-too status Irofit 100 mg/5 mL Injection by M/s Zafa Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator. Equivalency factor is not written
Decision: Deferred for revision of label claim as per reference product along with submission of
requisite fee.
210. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Re - Spa Injection (IM/IV) 40 mg / 2mL
Diary No. Date of R& I & fee Diary No:23205 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each 2mL Ampoule Contains:
Drotaverine hydrochloride ………. 40 mg
Pharmacological Group Antispasmodic
Minutes of 294th Meeting of Registration Board | 207
Type of Form Form-5
Finished Product Specification Manufacturer’s specs
Pack size & Demanded Price 2 mL x 1’s, 5’s & 25’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
reference for drotaverine 40mg/2ml injection in three
European countries
Me-too status Spink In 40 mg/2 mL Injection by M/s GT Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved with innovator’s specification.
211. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Ramal Injection (IM/IV) 100 mg / 2mL
Diary No. Date of R& I & fee Diary No: 23206 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each 2mL Ampoule Contains:
Tramadol hydrochloride ………. 100 mg
Pharmacological Group Opioid Analgesic
Type of Form Form-5
Finished Product Specification Mfg
Pack size & Demanded Price 2 mL x 1’s, 5’s, 10’s, 20’s & 50’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Zydol 100 mg / 2 ml Injection (MHRA Approved)
Me-too status Tramed 100 mg/2 mL Injection by M/s Cirin Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved with innovator’s specification.
212. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Rvil Injection (IM/IV) 25 mg / 2mL
Diary No. Date of R& I & fee Diary No: 23207 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each 2mL Ampoule Contains:
Pheniramine Maleate ………. 25 mg
Pharmacological Group Antihistamine
Type of Form Form-5
Finished Product Specification USP specs
Pack size & Demanded Price 2 mL x 10’s, 50’s & 100’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Could not be confirmed
Me-too status Zafvil 25 mg/2 mL Injection by M/s Zafa Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator. Reference product could not be confirmed
Decision: Deferred for evidence of approval of applied formulation in reference regulatory
authorities / agencies which were adopted by the Registration Board in its 275th meeting.
213. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Water For Injection (WFI) (IM/IV)
Diary No. Date of R& I & fee Diary No:23196 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each mL Ampoule Contains:
Water for Injection ………. 100 %
Pharmacological Group Diluent
Type of Form Form-5
Finished Product Specification USP specs
Pack size & Demanded Price 2 mL & 5mL x 1’s, 5’s, 10’s, 50’s & 100’s / As per SRO
Minutes of 294th Meeting of Registration Board | 208
Approval status of product in
Reference Regulatory Authorities.
Water for Injection (MHRA Approved)
Me-too status Water for Injection by M/s Pulse Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved. Firm will select one volume either 2ml or 5ml and Chairman Registration
Board is authorized to issue Registration letter accordingly.
214. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Ryloxaine Injection (IM) 20 mg / 2mL
Diary No. Date of R& I & fee Diary No: 23198 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each mL Ampoule Contains:
Lignocaine hydrochloride ………. 10 mg
Pharmacological Group Local Anaesthetic
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 2 mL x 5’s, 10’s, 50’s & 100’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Lidocaine 1 % Injection (MHRA approved)
Me-too status MHRA Approved
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
215. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Ryloxaine Injection (IM) 40 mg / 2mL
Diary No. Date of R& I & fee Diary No: 23197 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each mL Ampoule Contains:
Lignocaine hydrochloride ………. 20 mg
Pharmacological Group Local Anaesthetic
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 2 mL x 5’s, 10’s, 50’s & 100’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Lidocaine 2 % Injection (MHRA approved)
Me-too status Locaine 40 mg/2 mL Injection by M/s Saydon Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
Dry Powder Injection Section (Cephalosporin)
29 products/ 07 molecules
216. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Korephin Injection (I.M.) 250 mg
Diary No. Date of R& I & fee Diary No: 23216, 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each vial Contains:
Ceftriaxone sodium eq. to Ceftriaxone……250mg
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
USFDA Approved
Minutes of 294th Meeting of Registration Board | 209
Me-too status Oxidil 250 mg Injection by M/s Sami Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
217. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Korephin Injection (I.M.) 500 mg
Diary No. Date of R& I & fee Diary No:23215 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each vial Contains:
Ceftriaxone sodium eq. to Ceftriaxone……500mg
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
USFDA Approved
Me-too status Oxidil 500 mg Injection by M/s Sami Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
218. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Korephin Injection (I.M.) 1 g
Diary No. Date of R& I & fee Diary No: 23213 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each vial Contains:
Ceftriaxone sodium eq. to Ceftriaxone……1g
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
MHRA Approved
Me-too status Oxidil 1 g Injection by M/s Sami Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
219. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Korephin Injection (I.M.) 2 g
Diary No. Date of R& I & fee Diary No: 23212 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each vial Contains:
Ceftriaxone sodium eq. to Ceftriaxone……2 g
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Could not be confiremd
Me-too status Oxidil 2 g Injection by M/s Sami Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator. Reference product could not be confirmed
Decision: Deferred for evidence of approval of applied formulation in reference regulatory
authorities / agencies which were adopted by the Registration Board in its 275th meeting.
Minutes of 294th Meeting of Registration Board | 210
220. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Korephin Injection (I.V.) 250 mg
Diary No. Date of R& I & fee Diary No: 23208 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each vial Contains:
Ceftriaxone sodium eq. to Ceftriaxone……250 mg
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
USFDA Approved
Me-too status Oxidil 250 mg Injection by M/s Sami Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
221. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Korephin Injection (I.V.) 500 mg
Diary No. Date of R& I & fee Diary No: 23209, 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each vial Contains:
Ceftriaxone sodium eq. to Ceftriaxone……500 mg
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
USFDA Approved
Me-too status Oxidil 500 mg Injection by M/s Sami Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
222. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Korephin Injection (I.V.) 1 g
Diary No. Date of R& I & fee Diary No: 23201, 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each vial Contains:
Ceftriaxone sodium eq. to Ceftriaxone……1 g
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
USFDA Approved
Me-too status Oxidil 1 g Injection by M/s Sami Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
223. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Korephin Injection (I.V.) 2 g
Diary No. Date of R& I & fee Diary No: 23200 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Minutes of 294th Meeting of Registration Board | 211
Composition Each vial Contains:
Ceftriaxone sodium eq. to Ceftriaxone……2 g
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
MHRA Approved
Me-too status Oxidil 2 g Injection by M/s Sami Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
224. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Spaforan Injection (IM/IV) 250 mg
Diary No. Date of R& I & fee Diary No: 23211 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each vial Contains:
Cefotaxime Sodium eq to Cefotaxime………250mg
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
MHRA Approved
Me-too status Rifodime 250 mg Injection by M/s Medimarkers Labs
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
225. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Spaforan Injection (IM/IV) 500 mg
Diary No. Date of R& I & fee Diary No: 23217 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each vial Contains:
Cefotaxime Sodium eq to Cefotaxime………500mg
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
MHRA Approved
Me-too status Rifodime 500 mg Injection by M/s Medimarkers Labs
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
226. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Spaforan Injection (IM/IV) 1 g
Diary No. Date of R& I & fee Diary No: 23218 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each vial Contains:
Cefotaxime Sodium eq to Cefotaxime………1 g
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification USP Specs
Minutes of 294th Meeting of Registration Board | 212
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
MHRA Approved
Me-too status Rifodime 1g Injection by M/s Medimarkers Labs
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
227. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Spaforan Injection (IM/IV) 2 g
Diary No. Date of R& I & fee Diary No: 23219 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each vial Contains:
Cefotaxime Sodium eq to Cefotaxime………2 g
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
MHRA Approved
Me-too status Rifodime 2g Injection by M/s Medimarkers Labs
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
228. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Roftum Injection (IM/IV) 250 mg
Diary No. Date of R& I & fee Diary No: 23220, 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each vial Contains:
Ceftazidime pentahydrate eq to Ceftazidime buffered with
Sodium Carbonate………250mg
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Fortum 250 mg Dry Powder Injection M/s GlaxoSmithKline UK
(MHRA Approved)
Me-too status Biomed 250 mg Injection by M/s MediCraft Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
229. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Roftum Injection (IM/IV) 500 mg
Diary No. Date of R& I & fee Diary No: 23221 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each vial Contains:
Ceftazidime pentahydrate eq to Ceftazidime buffered with
Sodium Carbonate ………500mg
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Zorvolex 500 mg Injection by Iroko Pharmaceuticals
(MHRA Approved)
Minutes of 294th Meeting of Registration Board | 213
Me-too status Biomed 500 mg Injection by M/s MediCraft Pharma
GMP status New License (DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
230. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Roftum Injection (IM/IV) 1 g
Diary No. Date of R& I & fee Diary No: 23222 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each vial Contains:
Ceftazidime pentahydrate eq to Ceftazidime buffered with
Sodium Carbonate ………1 g
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Zorvolex 1g Injection by Iroko Pharmaceuticals
(MHRA Approved)
Me-too status Biomed 1 g Injection by M/s MediCraft Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
231. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Raxifime Injection (IM/IV) 500 mg
Diary No. Date of R& I & fee Diary No: 23214 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each vial Contains:
Cefipime as HCl (with L-Arginine)………..500mg
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
USFDA Approved
Me-too status Cepime 500 mg Injection by M/s Shaigan Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
232. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Raxifime Injection (IM/IV) 1 g
Diary No. Date of R& I & fee Diary No: 23224 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each vial Contains:
Cefipime as HCl (with L-Arginine)………..1 g
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
USFDA Approved
Me-too status Cepime 1 g Injection by M/s Shaigan Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Minutes of 294th Meeting of Registration Board | 214
Remarks of the Evaluator.
Decision: Approved.
233. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Ramnex Forte Injection (IM/IV) 1 g
Diary No. Date of R& I & fee Diary No: 23223 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each vial Contains:
Cefoperazone Sodium eq. to Cefoperazone …… 500mg
Sulbactum Sodium eq. to Sulbactum ………...…500mg
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification JP Specs
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
SULPERAZONE INJECTION by Pfizer Inc.
(PMDA Approved)
Me-too status Cebac 1 g Injection by M/s Bosch Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
234. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Ramnex Forte Injection (IM/IV) 2 g
Diary No. Date of R& I & fee Diary No: 23210 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each vial Contains:
Cefoperazone Sodium eq. to Cefoperazone …… 1000mg
Sulbactum Sodium eq. to Sulbactum ………...…1000mg
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification JP Specs
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Approved in 03 European countries, i.e., Czech Republic,
Poland and Slovakia
Me-too status Cebac 2 g Injection by M/s Bosch Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
235. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength SepStar Injection (IM/IV) 500 mg
Diary No. Date of R& I & fee Diary No: 24717 , 22-11-2019 , Rs: 20,000/- , 22-11-2019
Composition Each vial Contains:
Cefepime Hydrochloride eq to Cefepime………500mg
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Cefipime hydrochloride 500mg Injection
M/s Hospira, Inc. (USFDA approved)
Me-too status USPIME 500 mg Injection by M/S USAWAPharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
Minutes of 294th Meeting of Registration Board | 215
236. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength SepStar Injection (IM/IV) 1000 mg
Diary No. Date of R& I & fee Diary No: 24718, 22-11-2019 , Rs: 20,000/- , 22-11-2019
Composition Each vial Contains:
Cefepime Hydrochloride eq to Cefepime………1000mg
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Cefipime hydrochloride 500mg Injection
M/s Hospira, Inc. (USFDA approved)
Me-too status USPIME 1000 mg Injection by M/S USAWAPharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
237. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Refron Injection (IV) 500 mg
Diary No. Date of R& I & fee Diary No: 24709 , 22-11-2019 , Rs: 20,000/- , 22-11-2019
Composition Each vial Contains:
Cefpirome Sulphate eq. to Cefpirome ………500mg
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification Manufacturer’s Specs
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Cefrom Injection, ANSM (France) Approved
Me-too status Cefrom 500mg Injection by Sanofi Aventis
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved with innovator’s specification.
238. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Refron Injection (IV) 1000 mg
Diary No. Date of R& I & fee Diary No: 24710 , 22-11-2019 , Rs: 20,000/- , 22-11-2019
Composition Each vial Contains:
Cefpirome Sulphate eq. to Cefpirome ………1000mg
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification Manufacturer’s Specs
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Cefrom Injection, ANSM (France) Approved
Me-too status Cefrom 1000mg Injection by Sanofi Aventis
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved with innovator’s specification.
239. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Rizacef Injection (IM/IV) 125 mg
Diary No. Date of R& I & fee Diary No: 24711, 22-11-2019 , Rs: 20,000/- , 22-11-2019
Minutes of 294th Meeting of Registration Board | 216
Composition Each vial Contains:
Cefuroxime sodium eq. to Cefuroxime……. 125 mg
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
Cefuroxime by M/s Flynn Pharma Ltd, (MHRA Approved)
Me-too status CEFUSAVE 125mg Injection by M/S MEDISAVE Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
240. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Rizacef Injection (IM/IV) 250 mg
Diary No. Date of R& I & fee Diary No: 24712 , 22-11-2019 , Rs: 20,000/- , 22-11-2019
Composition Each vial Contains:
Cefuroxime sodium eq. to Cefuroxime……. 250 mg
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
ZINNAT 250 mg INJECTION by GSK UK, (MHRA
Approved)
Me-too status CEFUR 250 mg Injection by M/S Maxitech Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
241. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Rizacef Injection (IM/IV) 500 mg
Diary No. Date of R& I & fee Diary No: 24713 , 22-11-2019 , Rs: 20,000/- , 22-11-2019
Composition Each vial Contains:
Cefuroxime sodium eq. to Cefuroxime……. 500 mg
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
ZINNAT 500 mg INJECTION by GSK UK, (MHRA
Approved)
Me-too status CEFUR 500 mg Injection by M/S Maxitech Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
242. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Rizacef Injection (IM/IV) 750 mg
Diary No. Date of R& I & fee Diary No: 24714 , 22-11-2019 , Rs: 20,000/- , 22-11-2019
Composition Each vial Contains:
Cefuroxime sodium eq. to Cefuroxime……. 750 mg
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification USP
Minutes of 294th Meeting of Registration Board | 217
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
ZINNAT 750 mg INJECTION by GSK UK, (MHRA
Approved)
Me-too status EVOROX750mg Injection by M/S Pharm EVO
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
243. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Rizacef Injection (IM/IV) 1000 mg
Diary No. Date of R& I & fee Diary No: 24715, 22-11-2019 , Rs: 20,000/- , 22-11-2019
Composition Each vial Contains:
Cefuroxime sodium eq. to Cefuroxime……. 1000 mg
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
ZINNAT 1000mg INJECTION by GSK UK,(MHRA
Approved)
Me-too status EVOROX 1000 mg Injection by M/S Pharm EVO
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
244. Name and address of manufacturer /
Applicant
M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Rizacef Injection (IM/IV) 1.5 g
Diary No. Date of R& I & fee Diary No: 24716 , 22-11-2019 , Rs: 20,000/- , 22-11-2019
Composition Each vial Contains:
Cefuroxime sodium eq. to Cefuroxime……. 1.5 g
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 1’s, 5’s & 10’s / As per SRO
Approval status of product in
Reference Regulatory Authorities.
ZINNAT 1.5 g INJECTION by GSK UK,(MHRA Approved)
Me-too status KEFROX1.5g Injection by M/S CCL Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Remarks of the Evaluator.
Decision: Approved.
Case No. 07 Registration applications of drugs for which stability study data is submitted
c. Verification of stability study data 245. Name and address of manufacturer /
Applicant
M/s Sami Pharmaceuticals (Pvt.) Ltd. F-95, Off. Hub River
Road, S.I.T.E., Karachi
Brand Name +Dosage Form + Strength Lagita Double Action Suspension
500mg+213mg+325mg
Diary No. Date of R& I & fee Dyn:15674, 07-03-2019, Rs.50,000/- (04-03-2019)
Composition Each 10ml suspension contains:
Sodium Alginate…. 500mg
Sodium Bicarbonate…213 mg
Calcium Carbonate…325mg
Pharmacological Group Antacid
Type of Form Form-5 D
Minutes of 294th Meeting of Registration Board | 218
Finished Product Specification BP
Pack size & Demanded Price As per Drug Pricing policy, amber glass bottle 120ml, USP type
III
Approval status of product in Reference
Regulatory Authorities.
Gaviscon Double Action aniseed
MHRA Approved
Me-too status N/A
GMP status
Remarks of the Evaluator.
STABILITY STUDY DATA SUBMITTED INITIALLY
Drug Lagita Chewable Tablet
250mg+133.5mg+80mg
Name of Manufacturer M/s Sami Pharmaceuticals (Pvt.) Ltd. F-95, Off. Hub River Road, S.I.T.E., Karachi
Manufacturer of API Sodium Alginate
Qingdao Bright Moon
Seaweed Group Co. Ltd
Add:67, Haibin 1st Road,
Jiaonan , Qingdao, China
Sodium Bicarbonate
TATA Chemicals Europe
Limited Winnington
Lane, Northwich,
Cheshire, UK
Calcium Carbonate
Sudeep Pharma Pvt. Ltd.
Gujarat
API Lot No. H051707037 3195SB00950 18C/CP/080
Description of Pack
(Container closure system)
Alu PVC blister
Stability Storage Condition Real Time: 30°C ± 2°C / 65% ± 5%RH
Accelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real Time: 6 months Accelerated: 6 months
Frequency Real Time: 0,3,6,9,12,18,24,36 (months) Accelerated:0,1,2,3,4,6 (months)
Batch No. Lab-01 Lab-02 Lab-03
Batch Size 2500 tablets 2500 tablets 2500 tablets
Manufacturing Date July-2018
Date of Initiation July-2018
No. of Batches 3
Date of Submission Dyn:15674, 07-03-2019,
DOCUMENTS / DATA PROVIDED BY THE APPLICANT INITIALLY
Sr.
No.
Documents To Be Provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of
country of origin or GMP certificate of API
manufacturer issued by regulatory
authority of country of origin.
Yes Yes
3. Protocols followed for conduction of
stability study and details of tests. Yes
4. Data of 03 batches will be supported by
attested respective documents like
chromatograms, laboratory reports, data
sheets etc.
Yes
Minutes of 294th Meeting of Registration Board | 219
5. Documents confirming import of API etc. Sodium Alginate
Copy of Commercial Invoice (invoice no. BMM17132)
attested by Assistant Director (I & E) DRAP (Karachi)
dated 19-09-2017.
Quantity: 5000 Kg.
Sodium Bicarbonate
Copy of Commercial Invoice (invoice no. 8100088448)
attested by Assistant Director (I & E) DRAP (Karachi)
dated 1-06-2018.
Quantity: 5.250Kg.
Calcium Carbonate
Copy of Commercial Invoice (invoice no. SPP/EX021/18-
19) attested by Assistant Director (I & E) DRAP (Karachi)
dated 2-05-2018.
Quantity: 12Kg.
6. All provided documents will be attested
(name, sign and stamp) for ensuring
authenticity of data / documents.
Yes
7. Commitment to continue real time stability
study till assigned shelf life of the product. Yes
8. Commitment to follow Drug Specification
Rules, 1978.
Yes
REMARKS OF EVALUATOR2
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Lagita Double
Action Suspension 500mg + 213mg + 325mg (Sodium Alginate + Sodium bicarbonate + Calcium Carbonate)
Suspension by M/s. Sami Pharmaceutical (Pvt.) Ltd., F-95, S.I.T.E, Karachi.
Reference No: F.13-11/2017-PEC (pt) dated 26th December, 2019.
Investigation Date and Time: 30th January, 2020 (Morning).
Investigation Site: Factory premises of M/S. Sami Pharmaceutical (Pvt.) Ltd., F-95, S.I.T.E, Karachi.
Background:
Registration Board meeting considered the applications of M/s. Sami Pharmaceutical (Pvt.) Ltd., F-95, S.I.T.E,
Karachi for registration of Lagita Double Action Suspension 500mg + 213mg + 325mg (Sodium Alginate +
Sodium bicarbonate + Calcium Carbonate) Suspension. Registration Board considered scientifically rational
laboratory scale data submitted by the firm as pre-requisite of registration being new formulation and constituted
a three member panel to investigate the authenticity / genuineness of data (import of raw material and stability
data). Panel was advised to conduct inspection of the firm as per decision of Registration Board and to submit
report for further consideration.
Composition of Panel:
1. Dr. Rafeeq Alam Khan, Meritorious Professor, Department of Pharmacology, University of Karachi,
Karachi, Member Registration Board, Islamabad.
2. Dr. Saif-ur-Rehman Khattak, Director / FGA, CDL, DRAP, Karachi.
3. Mr. Kirshan Das, Assistant Director, DRAP Office, Karachi.
Scope of investigation:
Investigation of the authenticity / genuineness of data (import of raw material and stability data), manufacturing
of stability batches and stability studies on these batches.
Tools for Investigation:
The investigation was conducted by using a structured questionnaire of DRAP. For objective evidence physical
inspection of the facilities for manufacturing and quality control, material used and retained, personnel involved,
ongoing studies, printed data and integrity and security of data in respective databases were also audited. The
details of investigation may be summarized as under:
Minutes of 294th Meeting of Registration Board | 220
Detail of Investigation:
Sr.# Questions Remarks
1. Do you have documents confirming the
import API including approval from DRAP?
The firm has imported Sodium Alginate from M/s. Qingdao
bright moon seaweed – China (B.no. HO51707037) Qty.
received 5000 Kg as per invoice no. BMM17152, Sodium
Bicarbonate M/s TATA Chemicals – UK
(B.no.0000042802) Qty. received 25 Kg, Calcium
carbonate M/s Sudeep Pharma – India (B.No.18C/CP/080)
Qty. received 12kg as per invoice no. SPPL/EX021/18-19
and all material are cleared by ADC.
All these APIs are used in our already registered product,
hence the trial batches of Lagita double action suspension
manufactured from commercial import.
2. What was the rationale behind selecting the
particular manufacturer of API?
Sodium Alginate is already approved source using in other
registered products, having GMP, Vendor Evaluation form
and DMF.
Sodium Bicarbonate: Source is GMP qualified and having
DMF & Vendor Evaluation form.
Calcium Carbonate: Source is GMP qualified and having
DMF & Vendor Evaluation form.
3. Do you have documents confirming the
import of API reference standard and
impurity standards?
The firm has necessary documents related to import of the
sodium alginate and sodium bicarbonate reference
standards. No known impurity related to both APIs has been
reported in any pharmacopeia and relevant DMF.
4. Do you have certificate of Analysis of the
API, reference standards and impurity
standards?
The firm has CoAs of APIs and reference standards of the
APIs.
5. Do you have GMP certificate of APIs
manufacturer issued by regulatory authority
of country of origin?
The firm has the GMP certificate of Sodium Alginate from
M/s. Qingdao bright moon seaweed – China, Sodium
Bicarbonate from M/s TATA Chemicals – UK & Calcium
carbonate from M/s Sudeep Pharma – India.
6. Do you use APIs manufacturer method of
testing for testing APIs?
All APIs have been tested as per pharmacopeia (BP).
7. Do you have stability studies reports on API? The firm has the Stability study reports of APIs.
8. If yes, whether the stability testing has been
performed as per SIM method and
degradation products have been quantified?
Since there is no apparent degradation of the API’s, hence
no quantification of the degradation products can be made.
The stability indicating method in this case is not valid.
9. Do you have method for quantifying the
impurities in the API?
Since there is no apparent degradation of the API’s, hence
no quantification of the degradation products can be made.
The stability indicating method in this case is not valid.
10. Do you have some remaining quantities of
the API, its reference standard and impurities
standards?
The firm has some quantities in hand for working standards
of sodium alginate and sodium bicarbonate. Impurity
standards are invalid.
11. Have you used pharmaceutical grade
excipients?
The firm has used pharmaceutical grade excipients
including methyl paraben, propyl paraben, carbomer 974P,
sodium saccharine, peppermint flavor and sodium
hydroxide.
12. Do you have documents confirming the
import of the used excipients?
The firm has documents confirming the import of
excipients used.
13. Do you have test reports and other records on
the excipients used?
The firm has complete test reports and other records of the
excipients.
14. Do you have written and authorized
protocols for the development of Lagita
double action Suspension?
The firm has written and authorized protocol for the
development of product based on QbD approach.
Minutes of 294th Meeting of Registration Board | 221
15. Have you performed Drug-excipients
compatibility studies?
The firm has performed drug-excipients compatibility
studies as part of the QbD approach.
16. Have you performed comparative studies? The firm has performed comparative studies with Gaviscon
Double Action Suspension of M/s Reckitt Benkiser, UK for
this this dosage form.
17. Do you have product development (R&D)
section
The firm has dedicated section for the product development
(R&D).
18. Do you have necessary equipment available
in product development section for
development of Lagita double action
Suspension?
The firm has necessary equipment and instruments for the
development of products in our development section.
19. Are the equipments in product development
section qualified?
All equipments in product development section are
qualified.
20. Do you have proper maintenance /
calibration / re-qualification program for the
equipment used in PD section?
The firm has proper maintenance / calibration / re-
qualification program for the equipment used in Product
Development section.
21. Do you have qualified staff in product
development section with proper knowledge
and training in product development?
The firm has trained & qualified staff in product
development section with proper knowledge and training in
product development.
22. Have you manufactured three stability
batches for the stability studies of Lagita
double action Suspension as required?
The firm have manufactured three stability batches for
stability studies of Lagita double action Suspension with
batch numbers Lab-01, Lab-02 and Lab-03.
The batch sizes of all three batches are 26 liters each.
23. Do you have any criteria for fixing the batch
size of stability batches?
Batch size of stability batches are fixed according to the
sample requirements as per testing and frequencies during
stabilities studies.
24. Do you have complete record of production
of stability batches?
The firm has complete record of production of stability
batches.
25. Do you have protocols for stability testing of
stability batches?
The firm has protocols for stability testing of stability
batches.
26. Do you have developed and validated the
method for testing of stability batches?
The firm has developed and performed analytical method
validation studies for the testing of Lagita double action
Suspension.
27. Do you have method transfer studies in case
when the method of testing being used by
your firm is given by any other lab?
The firm has used the in-house developed and validated
method.
28. Do you have documents confirming the
qualification of equipments / instruments
being used in the test and analysis of API and
the finished drug?
The firm has proper documents confirming the qualification
of equipment / instruments being used in the test and
analysis of API and the finished drug.
29. Do your method of analysis stability
indicating?
Not applicable
30. Do your HPLC software 21CFR Compliant? The HPLC software is 21CFR Compliant.
31. Can you show Audit trail reports? Audit trail report are available and reviewed.
32. Do you have some remaining quantities of
degradation products and stability batches?
The firm has remaining quantities of stability batches.
33. Do you have stability batches kept on
stability testing?
The firm has kept all the 3 batches on real time stability
program. 18 months studies are complete and results are
satisfactory.
34. Do you have valid calibration status for the
equipments used in Lagita double action
Suspension production and analysis?
The firm has valid calibration status for the equipment used
in Lagita double action Suspension.
Minutes of 294th Meeting of Registration Board | 222
35. Do proper and continuous monitoring and
control are available for stability chamber?
Adequate monitoring and control are available for stability
chambers.
Data Loggers are attached with stability chambers.
36. Do related manufacturing area, equipment,
personnel and utilities be rated as GMP
compliant?
All manufacturing area, equipment, personnel and utilities
are GMP compliant.
Conclusions:
1. On the basis of risk-based approach the genuineness / authenticity of stability data submitted by the firm
for registration of Lagita Double Action Suspension 500mg + 213mg + 325mg (Sodium Alginate + Sodium
bicarbonate + Calcium Carbonate) Suspension is verifiable to satisfactory level.
2. The related manufacturing area, equipment, personnel and utilities are GMP compliant and well suited
for the manufacturing of Lagita Double Action Suspension 500mg + 213mg + 325mg (Sodium Alginate + Sodium
bicarbonate + Calcium Carbonate) Suspension.
Recommendations:
The firm may kindly be granted necessary registration of Lagita Double Action Suspension 500mg + 213mg +
325mg (Sodium Alginate + Sodium bicarbonate + Calcium Carbonate) Suspension.
Decision: Registration Board decided to approve registration of Lagita Double Action Suspension
by M/s Sami Pharmaceutical (Pvt.) Ltd., F-95, S.I.T.E, Karachi. Manufacturer will place first
three production batches on long term stability studies throughout proposed shelf life and on
accelerated studies for six months.
246. Name, address of Applicant / Marketing
Authorization Holder
M/s CCL Pharmaceuticals Pvt Ltd. 65-Industrial Estate,
Kot Lakhpat, Lahore-54770, Pakistan.
Name, address of Manufacturing site. M/s CCL Pharmaceuticals Pvt Ltd. 62-Industrial Estate,
Kot Lakhpat, Lahore-54770, Pakistan.
Status of the applicant Manufacturer Importer
Is involved in none of the above (contract giver)
Dy No. and date of submission Dy No. 13406, : 5-12-2018
Details of fee submitted PKR 20,000/-: 3-12-2018
The proposed proprietary name/brand name Dexlan DR Capsule 60mg
Strength / concentration of drug of Active
Pharmaceutical ingredient (API) per unit
Each capsule contains:
Dexlansoprazole (as Delayed release pellets)…….60mg
Dosage form of applied drug Capsule
Route of administration Oral
Pharmacotherapeutic Group of (API) Antacids/ Antiflatulents/Antipeptic ulcerant
Pharmacopoeial reference Firm has submitted:- “Innovators Specifications”
Proposed Pack size 10’s, 14’s, 20’s, 28’s and 30’s
Proposed unit price As per Innovator’s Price
The status in reference regulatory authorities USFDA Approved
For generic drugs (me-too status)
Valid drug manufacturing license/Drug Sale
License
Copy of Drug manufacturing License by way of
formulation issued on 21-7-2015 is submitted.
Evidence of approval of manufacturing
facility / approved section from licensing
authority
Copy of grant of Additional section (Capsule General
section Revised) from CLB is submitted
Type of Application New Drug Product (NDP)
Generic Drug Product (GDP)
Minutes of 294th Meeting of Registration Board | 223
Intended use of pharmaceutical product Domestic sale
Export sale
Domestic and Export sales
For imported products, please specify one of
following:
Finished Pharmaceutical Product Import
Bulk Import and local repacking (Specify status of
bulk)
Bulk Import local repacking for Export purpose only
Contract Manufacturing as per Rule 20-A of
Drugs (Licensing, Registering and
Advertising) Rules, 1976
Domestic Manufacturing
List of registered products NA
Manufacturer’s site master file and
credentials (for importers)
Yes
Identification of signature of authorized persons, Incharge
Production, Quality Control & Quality Assurance of manufacturer.
Yes
Proposed label (outer (secondary) & inner (primary)) & colour
scheme in accordance with Drug (Labelling & Packing) Rules,
1986 along with specimens
Yes
Description of Batch numbering system Yes
Training evidence of technical staff with respect of manufacturing
of applied drug (mandatory in case of specially designed
pharmaceutical product / Novel Dosage Form).
Not Applicable
Summary of Product Characteristics (SmPC) including
Prescribing Information (PI) along with Patient information
Leaflet (PIL) of the Finished Pharmaceuticals Product (FPP).
Yes
Commitments Firm has submitted
undertaking/commitments on it’s
letter head
Protocols along with the commitment to follow Good Laboratory
Practices (GLP) by the Manufacturer.
Yes
Protocols to implement Good Pharmacovigilance Practice by the
Pharmacovigilance department/section of the Manufacturer /
Company.
Yes
Information on Prior-related Applications N/A
Electronic Review Package N/A
QIS (Quality Information Summary) Yes
Drug Substance related Document including following:
a. Name and address of API manufacturer. M/s Vision Pharmaceuticals Pvt Ltd.
Plot No. 22, Industrial Triangle Kahuta road,
Islamabad
b. Approval of manufacturing facility of API by
regulatory body of country and validity.
Copy of Drug manufacturing License by way
of Semi-basic issued on 2-12-2014 is
submitted.
c. Vendor qualification / audit is Document based
Site inspection based
d. Reason for above point (c) Already approved vendor for other API’s
MODULE 2: OVERVIEWS & SUMMARIES
Minutes of 294th Meeting of Registration Board | 224
Drug Substance Firm has submitted overall summary of drug substance including general
information, specification, and characterization, control of the API,
reference standard, container closure system and stability.
Drug Product Firm has submitted summary of drug product including description and
composition of drug product, pharmaceutical development, manufacture,
control of excipients, manufacturing process development, container
closure system, microbiological attributes and compatibility, controls of
drug product, reference standards or materials and stability studies.
MODULE 3: QULITY / CMC
3.2.S: Drug substance
Firm has submitted details of drug substance and pellets including the stability studies data.
3.2.P: Drug Product
Description and composition of
drug product
Firm has submitted description and composition of drug product
Pharmaceutical development Firm has provided details of drug substance, excipients, formulation
development, overages, physicochemical and biological properties,
manufacturing process development, container closure system,
microbiological attributes and compatibility.
Manufacture Firm has submitted detail of manufacturer, batch formula,
description of manufacturing process and process controls, controls
of critical steps and intermediates, process validation and or
evaluation.
Control of excipients N/A
Control of drug product Firm has submitted details of specification, analytical procedures,
validation of analytical procedures, batch analysis, and
characterization of impurities and justification of specification.
Reference standard or materials Firm has submitted certificate of analysis of reference standards and
impurity standards
Container closure system HDPE bottle with dessicant
Stability Firm has provided complete stability study data of 3 batches as per
Zone IV-A
Comparative dissolution profile
MODULE 4: NON-CLINICAL / SAFETY
Pharmacology Firm has submitted that being a generic product non-clinical data is
not Applicable
Pharmacokinetics Firm has submitted that being a generic product non-clinical data is
not Applicable
Toxicology Firm has submitted that being a generic product non-clinical data is
not Applicable
MODULE 5: CLINICAL / EFFICACY
Firm has submitted that being a generic product clinical data is not Applicable while in-vitro dissolution
tests complementary to bioequivalence studies.
STABILITY STUDY DATA
Manufacturer of API M/s Vision Pharmaceuticals Pvt Ltd.
Plot No. 22, Industrial Triangle Kahuta road, Islamabad
Firm is obtaining API pellets from the above Manufacturer.
API Lot No. Batch NO. DLP287
Minutes of 294th Meeting of Registration Board | 225
Description of Pack
(Container closure system)
Alu-Alu blister pack
Stability Storage Condition Real time : 30°C ± 2°C / 75% ± 5%RH
Accelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real time: 6 months
Accelerated: 6 months
Frequency Accelerated: 0, 3,6 (Months)
Real Time: 0, 3,6(Months)
Batch No. DXB T1/18 DXB T2/18 DXB T3/18
Batch Size 1500 capsules 1500 capsules 1500 capsules
Manufacturing Date July-2018 July-2018 July-2018
Date of Initiation July-2018 July-2018 July-2018
No. of Batches 03
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Documents To Be Provided Status
COA of API Yes
Approval of API by regulatory authority of country of origin
or GMP certificate of API manufacturer issued by regulatory
authority of country of origin.
cGMP certificate is valid until 25-1-
2019.
Protocols followed for conduction of stability study and
details of tests.
Yes
Data of 03 batches will be supported by attested respective
documents like chromatograms, laboratory reports, data
sheets etc.
Yes
Documents confirming import of API etc. Yes
All provided documents will be attested (name, sign and
stamp) for ensuring authenticity of data / documents.
Yes
REMARKS OF EVALUATOR
Dexlan DR Capsule 60mg
S.# Shortcoming/Letter communicated to firm Firm Reply/Evaluation of firm’s reply
1. 1. Ref to your response (Annexure-IV). Process
validation data is not provided. Summary of validation
studies including the proposed protocol that will be
used for the validation of three commercial batches is
not provided.
2. Ref to your response (Annexure-X). The submitted
justification for specification is not considered
satisfactory. All specifications are developed as per In-
house standards and the same is mentioned in
justification. Kindly justify the specification with the
scientific rationale.
3. Ref to your response (Annexure-XV). Your response
is considered not satisfactory. You have to perform
comparative dissolution profile of your drug product
against the innovators product in three dissolution
mediums i.e. pH1.2, 4.5 and 6.8 as per dissolution
parameters defined in FDA dissolution database.
Firm has submitted, “Process validation
will be performed of 3 stability batches and
it shall be submitted to drap. However,
Process validation protocol is submitted.”
Firm has only provided the use of the test
parameter and not the justification.
Firm has performed CDP only on pH 7.0
Minutes of 294th Meeting of Registration Board | 226
Results of dissolution should be presented after
calculation of similarity factor f2.
247. Name, address of Applicant / Marketing
Authorization Holder
M/s CCL Pharmaceuticals Pvt Ltd. 65-Industrial
Estate, Kot Lakhpat, Lahore-54770, Pakistan.
Name, address of Manufacturing site. M/s CCL Pharmaceuticals Pvt Ltd. 62-Industrial
Estate, Kot Lakhpat, Lahore-54770, Pakistan.
Status of the applicant Manufacturer Importer
Is involved in none of the above (contract giver)
Dy No. and date of submission Dy No. 13405, : 5-12-2018
Details of fee submitted PKR 20,000/-: 3-12-2018
The proposed proprietary name / brand name Dexlan DR Capsule 30mg
Strength / concentration of drug of Active
Pharmaceutical ingredient (API) per unit
Each capsule contains:
Dexlansoprazole (as Delayed release
pellets)…….30mg
Dosage form of applied drug Capsule
Route of administration Oral
Pharmacotherapeutic Group of (API) Antacids/ Antiflatulents/Antipeptic ulcerant
Pharmacopoeial reference Firm has submitted:- “Innovators Specifications”
Proposed Pack size 10’s, 14’s, 20’s, 28’s and 30’s
Proposed unit price As per Innovator’s Price
The status in reference regulatory authorities USFDA Approved
For generic drugs (me-too status)
Valid drug manufacturing license/Drug Sale
License
Copy of Drug manufacturing License by way of
formulation issued on 21-7-2015 is submitted.
Evidence of approval of manufacturing facility
/ approved section from licensing authority
Copy of grant of Additional section (Capsule General
section Revised) from CLB is submitted
Type of Application New Drug Product (NDP)
Generic Drug Product (GDP)
Intended use of pharmaceutical product Domestic sale
Export sale
Domestic and Export sales
For imported products, please specify one of
following:
Finished Pharmaceutical Product Import
Bulk Import and local repacking (Specify status of
bulk)
Bulk Import local repacking for Export purpose only
Contract Manufacturing as per Rule 20-A of
Drugs (Licensing, Registering and
Advertising) Rules, 1976
Domestic Manufacturing
List of registered products NA
Manufacturer’s site master file and credentials
(for importers)
Yes
Identification of signature of authorized persons, Incharge
Production, Quality Control & Quality Assurance of manufacturer.
Yes
Minutes of 294th Meeting of Registration Board | 227
Proposed label (outer (secondary) & inner (primary)) & colour
scheme in accordance with Drug (Labelling & Packing) Rules, 1986
along with specimens
Yes
Description of Batch numbering system Yes
Training evidence of technical staff with respect of manufacturing of
applied drug (mandatory in case of specially designed pharmaceutical
product / Novel Dosage Form).
Not Applicable
Summary of Product Characteristics (SmPC) including Prescribing
Information (PI) along with Patient information Leaflet (PIL) of the
Finished Pharmaceuticals Product (FPP).
Yes
Commitments Firm has submitted
undertaking/commitments on
it’s letter head
Protocols along with the commitment to follow Good Laboratory
Practices (GLP) by the Manufacturer.
Yes
Protocols to implement Good Pharmacovigilance Practice by the
Pharmacovigilance department/section of Manufacturer / Company.
Yes
Information on Prior-related Applications N/A
Electronic Review Package N/A
QIS (Quality Information Summary) Yes
Drug Substance related Document including following:
a. Name and address of API manufacturer. M/s Vision Pharmaceuticals Pvt Ltd. Plot No.
22, Industrial Triangle Kahuta road, Islamabad
b. Approval of manufacturing facility of API by
regulatory body of country and validity.
Copy of Drug manufacturing License by way of
Semi-basic issued on 2-12-2014 is submitted.
c. Vendor qualification / audit is Document based
Site inspection based
d. Reason for above point (c) Already approved vendor for other API’s
MODULE 2: OVERVIEWS & SUMMARIES
Drug Substance Firm has submitted overall summary of drug substance including
general information, specification, and characterization, control of
the API, reference standard, container closure system and stability.
Drug Product Firm has submitted summary of drug product including description
and composition of drug product, pharmaceutical development,
manufacture, control of excipients, manufacturing process
development, container closure system, microbiological attributes
and compatibility, controls of drug product, reference standards or
materials and stability studies.
MODULE 3: QULITY / CMC
3.2.S: Drug substance
Firm has submitted details of drug substance and pellets including the stability studies data.
3.2.P: Drug Product
Description and composition of
drug product
Firm has submitted description and composition of drug product
Pharmaceutical development Firm has provided details of drug substance, excipients,
formulation development, overages, physicochemical and
biological properties, manufacturing process development,
Minutes of 294th Meeting of Registration Board | 228
container closure system, microbiological attributes and
compatibility.
Manufacture Firm has submitted detail of manufacturer, batch formula,
description of manufacturing process and process controls,
controls of critical steps and intermediates, process validation and
or evaluation.
Control of excipients N/A
Control of drug product Firm has submitted details of specification, analytical procedures,
validation of analytical procedures, batch analysis, and
characterization of impurities and justification of specification.
Reference standard or materials Firm has submitted certificate of analysis of reference standards
and impurity standards
Container closure system HDPE bottle with dessicant
Stability Firm has provided completed stability study data of 3 batches as
per Zone IV-A
Comparative dissolution profile
MODULE 4: NON-CLINICAL / SAFETY
Pharmacology Firm has submitted that being a generic product non-clinical data
is not Applicable
Pharmacokinetics Firm has submitted that being a generic product non-clinical data
is not Applicable
Toxicology Firm has submitted that being a generic product non-clinical data
is not Applicable
MODULE 5: CLINICAL / EFFICACY
Firm has submitted that being a generic product clinical data is not Applicable while in-vitro dissolution
tests complementary to bioequivalence studies.
STABILITY STUDY DATA
Manufacturer of API M/s Vision Pharmaceuticals Pvt Ltd.
Plot No. 22, Industrial Triangle Kahuta road, Islamabad
Firm is obtaining API pellets from the above Manufacturer.
API Lot No. Batch NO. DLP287
Description of Pack
(Container closure system)
Alu-Alu blister pack
Stability Storage Condition Real time : 30°C ± 2°C / 75% ± 5%RH
Accelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real time: 6 months
Accelerated: 6 months
Frequency Accelerated: 0, 3,6 (Months)
Real Time: 0, 3,6(Months)
Batch No. DXB T1/18 DXB T2/18 DXB T3/18
Batch Size 1500 capsules 1500
capsules
1500 capsules
Manufacturing Date July-2018 July-2018 July-2018
Date of Initiation July-2018 July-2018 July-2018
No. of Batches 03
Minutes of 294th Meeting of Registration Board | 229
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Documents To Be Provided Status
COA of API Yes
Approval of API by regulatory authority of country of origin
or GMP certificate of API manufacturer issued by regulatory
authority of country of origin.
cGMP certificate is valid until 25-1-
2019.
Protocols followed for conduction of stability study and details
of tests.
Yes
Data of 03 batches will be supported by attested respective
documents like chromatograms, laboratory reports, data sheets
etc.
Yes
Documents confirming import of API etc. Yes
All provided documents will be attested (name, sign and
stamp) for ensuring authenticity of data / documents.
Yes
REMARKS OF EVALUATOR
Dexlan DR Capsule 30mg
S.No Shortcoming/Letter communicated to firm Firm Reply / Evaluation of the firm’s
reply
2. 4. Ref to your response (Annexure-IV). Process validation
data is not provided. Summary of validation studies
including the proposed protocol that will be used for the
validation of three commercial batches is not provided.
5. Ref to your response (Annexure-X). The submitted
justification for specification is not considered satisfactory.
All specifications are developed as per In-house standards
and the same is mentioned in justification. Kindly justify
the specification with the scientific rationale.
6. Ref to your response (Annexure-XV). Your response is
considered not satisfactory. You have to perform
comparative dissolution profile of your drug product
against the innovators product in three dissolution
mediums i.e. pH1.2, 4.5 and 6.8 as per dissolution
parameters defined in FDA dissolution database. Results
of dissolution should be presented after calculation of
similarity factor f2.
Firm has submitted, “Process validation
will be performed of 3 stability batches
and it shall be submitted to drap.
However, Process validation protocol is
submitted.”
Firm has only provided the use of the test
parameter and not the justification.
Firm has performed CDP only on pH 7.0
Inspection Report
PART-I:
1.1 General Information.
Name of Manufacturer M/s CCL Pharmaceuticals (Pvt.) Ltd.
Physical Address 62 Industrial Estate, Kot Lakhpat, Lahore.
Drug Manufacturing License
No. and validity
000052 by way of formulation
Valid till 20-07-2020.
Contact Address Mr. Irfan Sohail
Senior Manager Regulatory Affairs 0308-8884984
Date of Inspection. 26-08-2019
Purpose of Inspection Verification of authenticity of stability data for purpose of registration of
drugs with reference to DRAP’s letter No. F.13-11/2017-PEC (Pt) dated
30-07-2019.
Name of Inspector 01. Mr. Shaheen Iqbal, Director, DTL, Lahore.
02. Ms. Aisha Irfan, Area FID, DRAP, Lahore.
Minutes of 294th Meeting of Registration Board | 230
03. Mr. Hafiz Ahsan, Assistant Director, PEC (DRAP) Islamabad.
Name of firm Representatives Dr. Rizwan Mahmood, Director Quality Operations
Mr. Kamran Atif, Director Regulatory Affairs
Mr. Irfan Sohail, Senior Manager Regulatory Affairs
Mr. Shahid Anwar, General Manager R&D
Mr. Muhammad Fiaz, Quality Control Manager
Mr. Farhan Qureshi, Quality Assurance Manager
General Information about unit:
The firm is located in the industrial area at 62 Industrial Estate, Kot Lakhpat, Lahore, Pakistan. The firm was
established in 1965 initially and shifted to the existing site in 1984. The firm has production facility, supply chain,
engineering, quality control, quality assurance, research & development, regulatory and administrative
departments. The production operations at firm involve manufacturing, packaging and distribution of finished
pharmaceutical products. The firm is manufacturing generic products.
1.2 Focus of Inspection:
The inspection was focused on a thorough evaluation of data for stability studies of following products namely:
Sr. No. Name / Composition of Drugs
01 Dexlan DR Capsule 30mg
Each capsule contains:
Dexlansoprazole (as Delayed release pellets)………….30mg
02 Dexlan DR Capsule 60mg
Each capsule contains:
Dexlansoprazole (as Delayed release pellets)………….60mg
Panel also visited the R&D Laboratory and Quality Control Laboratory of the firm. The data was evaluated
according to the checklist provided as given below:
Details of investigation:
i) Dexlan DR Capsule 30mg and Dexlan DR Capsule 60mg
Q.# Questions Observation by panel
1. Do you have documents confirming the
import of Dexlansoprazole delayed
release pellets APIs including approval
from DRAP?
The firm has procured 2kg Dexlansoprazole DDR 22.5%
pellets from M/s. Vision Pharmaceuticals, Islamabad (Batch
No. DLP287 and Invoice No. is 501646). API
Dexlansoprazole was procured from M/s Integrin Life
Sciences, Telangana, India by Vision Pharma.
2. What was the rationale behind selecting
the particular manufacturer of API?
Firm informed that they selected M/s Vision
Pharmaceuticals, Islamabad based on their Vendor
Qualification SOP.
3. Do you have documents confirming the
import of reference standard and impurity
standards?
Firm purchased Dexlansoprazole working standard from
M/s Vision Pharmaceuticals, Islamabad, invoice no. 501646
dated 03.05.2018, and Dexlansoprazole sulphone and
sulphide impurities from M/s Vision Pharmaceuticals,
Islamabad, through Ref no. PO#IMP-0419 dated
01.04.2019 manufactured by M/s Integrin Life Sciences,
Telangana, India
4. Do you have certificate of Analysis of the
API, reference standards and impurity
standards?
The firm had certificate of analysis for Dexlansoprazole
DDR Pellets, working standards and impurities standards
manufactured by M/s Integrin Life Sciences, Telangana,
India.
5. Do you have GMP certificate of API
manufacturer issued by regulatory
authority of country of origin?
Firm had provided valid GMP Certificate of M/s Vision
Pharmaceuticals, Islamabad issued by Additional Director
(QA & LT-I), DRAP, Islamabad dated 25th Feb, 2019.
Minutes of 294th Meeting of Registration Board | 231
6. Do you use API manufacturer method of
testing for testing API?
The firm used pellets manufacturer’s method of testing
which was validated.
7. Do you have stability studies reports on
API?
The firm had stability studies reports on DDR pellets from
Vision Pharma conducted at Zone IV-A conditions.
8. If yes, whether the stability testing has
been performed as per SIM method and
degradation products have been
quantified?
The stability testing had been performed as per SIM
method.
9. Do you have method for quantifying the
impurities in the API?
Firm had testing method to quantify the impurities as per
raw material manufacturers.
10. Do you have some remaining quantities of
the API, its reference standard and
impurities standards?
The firm had some remaining quantities of the DDR pellets
(Quantity = 187.25g) whereas working standard and
impurities are NIL.
11. Have you used pharmaceutical grade
excipients?
Since the product is filling of already prepared pellets in
Hard gelatin capsule and capsule shells used (size # 2 for
60mg & size # 4 for 30mg) were of pharmaceutical grade as
per the COA and related documents.
12. Do you have documents confirming the
import of the used excipients?
The firm has purchased Hard gelatin capsule shell from
local source i.e., M/s Gelcap, Karachi.
13. Do you have test reports and other records
on the excipients used?
The firm has test reports and other records on the excipient
used.
14. Do you have written and authorized
protocols for the development of
Dexlansoprazole Capsule?
The firm had written and authorized protocols for the
development of Dexlansoprazole Capsules. However, firm
was advised to improve the product development protocol.
15. Have you performed Drug-excipient
compatibility studies?
Not applicable.
16. Have you performed comparative
dissolution studies?
The firm has performed comparative dissolution studies
with reference product DEXILANT 30mg and 60mg
capsules manufactured by M/s. Takeda, USA. The
dissolution profiles of the firm capsules are comparable to
that of the reference product.
17. Do you have product development (R&D)
section
The firm had product development (R&D) section.
18. Do you have necessary equipment
available in product development section
for development of Dexlansoprazole
Capsule?
The firm had used commercial production area for filling of
pellets in capsules using automatic capsule filling machine.
19. Are the equipment in product
development section qualified?
The equipments used in product development were
qualified.
20. Do you have proper maintenance /
calibration / re-qualification program for
the equipment used in PD section?
The firm had proper maintenance / calibration / re-
qualification program for the equipment used in product
development section.
21. Do you have qualified staff in product
development section with proper
knowledge and training in product
development?
The firm had 06 Pharmacists and 02 Chemists in product
development section with suitable knowledge and training
in product development.
22. Have you manufactured three stability
batches for the stability studies of
Dexlansoprazole Capsule as required?
The firm had manufactured three stability batches for the
stability studies of Dexlansoprazole Capsules (30mg and
60mg) with batch numbers i.e. DXA-T1-18, DXA-T2-18
and DXA-T3-18 for 30mg strength and DXB-T1-18, DXB-
T2-18 and DXB-T3-18 for 60mg strength. The batch size
for these batches are 1,500 capsules each.
Minutes of 294th Meeting of Registration Board | 232
23. Do you have any criteria for fixing the
batch size of stability batches?
The firm had criteria for fixing the batch size of stability
batches as per their internal document CQP-004-H in the
light of DRAP letter No. F.3-2/2014-I&E dated 08-12-2015.
24. Do you have complete record of
production of stability batches?
The firm had record of production of stability batches for
which firm has provided Trial Forms.
25. Do you have protocols for stability testing
of stability batches?
The firm had detailed protocols for stability testing of
stability batches.
26. Do you have developed and validated the
method for testing of stability batches?
The firm had developed and validated method of testing for
finished product based on method of testing of API
manufacturer. Validation of assay method was completed in
September, 2018 while first analysis of trial batches was
performed in July, 2018. Dissolution method validation was
not performed.
27. Do you have method transfer studies in
case when the method of testing being
used by your firm is given by any other
lab?
NA
28. Do you have documents confirming the
qualification of equipment / instruments
being used in the test and analysis of
Dexlansoprazole Capsule API and the
finished drug?
The firm had proper documents confirming the qualification
of equipment / instruments being used in the test and
analysis of API and the finished drug.
29. Do your method of analysis stability
indicating?
The firm had used spike method to demonstrate that their
method is stability indicating.
30. Do your HPLC software 21CFR
Compliant?
HPLC used in the stability studies of current products was
gradient and not 21CFR 11 compliant. However, now the
firm has procured HPLC software 21CFR Compliant.
31. Can you show Audit trail reports on
Dexlansoprazole Capsule testing?
The audit trail was not active on the testing reports and log
of data was available in the HPLCs. The data was also
confirmed through record, chromatograms and logbooks.
32. Do you have some remaining quantities of
degradation products and stability
batches?
The firm had remaining quantities (108 capsules of each
batch) of stability batches.
33. Do you have stability batches kept on
stability testing?
The firm had stability batches kept on stability testing.
34. Do you have valid calibration status for
the equipment used in Dexlansoprazole
Capsule production and analysis?
The firm had valid calibration status for the equipment used
in Dexlansoprazole Capsule production and analysis.
35. Do proper and continuous monitoring &
control are available for stability
chamber?
Adequate monitoring and control was available for stability
chamber. The firm has provided uninterrupted power supply
by UPS and generator.
36. Do related manufacturing area,
equipment, personnel and utilities be rated
as GMP compliant?
Requisite facilities were satisfactory and GMP compliant.
CLARIFICATION:
(i) The firm has developed Process Validation Protocols and has committed to perform Process Validation
on commercial batch.
(ii) The firm has performed comparative dissolution profile at three mediums i.e. 0.1N HCl pH 1.2, Acetate
buffer pH 4.5 & Phosphate buffer pH 6.8.
RECOMMENDATIONS:
Based on the area inspected, the technical personnel met and the documents reviewed, and considering the
findings of inspection, the panel is of the opinion that the data provided by the firm M/s. CCL Pharmaceuticals
Minutes of 294th Meeting of Registration Board | 233
(Pvt.) Ltd., 62 Industrial Estate, Kot Lakhpat, Lahore, Pakistan regarding stability studies of following products
was satisfactory and the stability studies were conducted by the firm.
Decision of 291st : Deferred for following:
Clarification/justification for not submitting details of drug substance as mentioned in 3.2.S of Module 3 of
CTD.
Justification is required for not performing process validation as mentioned in 3.2.P.3.5 of Module 3 of CTD.
Evaluation by PEC:
The firm has submitted DMF of dexlansoprazole API from the supplier i.e. M/s Everest Organics Ltd, India
The firm has stated that Process Validation of dexlansoprazole pellets has been performed by our source i.e
M/s Vision Pharmaceuticals, Islamabad which is duly DRAP approved. CCL only filled said pellets leading to
blistering and packaging of trial baches. In addition, CCL commit to perform process validation at commercial
batches.
Decision: Registration Board decided to approve registration of Dexlan DR Capsule 30mg &
Dexlan DR Capsule 60mg with Innovator’s specifications by M/s CCL Pharmaceuticals (Pvt.)
Ltd., 62 Industrial Estate, Kot Lakhpat, Lahore. Manufacturer will place first three production
batches on long term stability studies throughout proposed shelf life and on accelerated studies
for six months. Manufacturer will also perform process validation studies on first three
commercial batches as per the commitment submitted along with registration application.
Sr.
No.
Name & Address of
Manufacturer /
Applicant
Brand Name
(Proprietary Name +
Dosage Form +
Strength), Composition,
Pharmacological Group,
Finished Product
Specification
Type of Form,
Initial Diary &
Date, Fee
(including
differential fee),
Demanded Price
/ Pack size
International
Availability / Local
Availability
GMP Inspection
Report Date &
Remarks
Previous DRB
Decision /
Remarks
(if any)
248. M/s Hiranis
Pharmaceuticals
Pvt Ltd. Plot No.E-
145 to E-149, Port
Qasim, Karachi
Etoxib 120mg tablets
Each film coated tablet
contains:
Etoricoxib……120mg
COX-2 Inhibitor
Dy. 42315
Form-5-D
7’s- Rs.585
10’s-Rs.835
20’s-Rs.1670
11-12-2018
Rs.50,000
11-12-2018
MHRA Approved
7-9-2017 Overall
GMP compliance is
found at
satisfactory level.
Manufacturer’s
Specifications.
STABILITY STUDY DATA
Drug Etoxib 120mg tablets
Name of Manufacturer M/s Hiranis Pharmaceuticals Pvt Ltd. Plot No.E-145 to E-149, Port Qasim,
Karachi
Manufacturer of API M/s Glenmark, Maharashtra, India
API Lot No. Batch No. 84170430
Description of Pack
(Container closure system)
Alu/Alu packing
Stability Storage Condition Accelerated: 40°C ± 2°C & 75±5%RH
Real Time: 30°C ± 2°C & 65±5%RH
Time Period Accelerated: 6Months Real Time: 6Months
Frequency Accelerated: Initial,1,3,6(Months) Real Time: Initial, 1,3,6 (Month)
Batch No. TF-020418 TF-030418 TF-040418
Batch Size 2500 Tablets 2500 Tablets 2500 Tablets
Manufacturing Date 04-2018 04-2018 04-2018
Date of Initiation 04-2018 04-2018 04-2018
Minutes of 294th Meeting of Registration Board | 234
No. of Batches 03
Date of Submission Dairy 42315, 11-12-2018
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr. Documents To Be Provided Status
1. COA of API COA from M/s Glenmark, Maharashtra, India is
attached.
2. Approval of API by regulatory authority of country
of origin or GMP certificate of API manufacturer
issued by regulatory authority of country of origin.
GMP certificate issued from Food and Drug
Administration Bandra-Kurla Complex, Mumbai,
Maharashtara, India that is valid upto 24-5-2021
3. Protocols followed for conduction of stability study
and details of tests.
Yes
4. Data of 03 batches will be supported by attested
respective documents like chromatograms,
laboratory reports, data sheets etc.
Yes
5. Documents confirming import of API etc. Yes
6. All provided documents will be attested (name, sign
and stamp) for ensuring authenticity of data /
documents.
Yes
7. Commitment to continue real time stability study till
assigned shelf life of the product.
Yes
8. Commitment to follow Drug Specification Rules,
1978.
Yes
REMARKS OF EVALUATOR(VI)
The panel is requested to evaluate the addition of 5% overage in the finish product stability batches.
Sr. No.
Name & Address of
Manufacturer /
Applicant
Brand Name
(Proprietary Name +
Dosage Form + Strength),
Composition,
Pharmacological Group,
Finished Product
Specification
Type of Form,
Initial Diary &
Date, Fee
(including
differential fee),
Demanded
Price / Pack size
International
Availability / Local
Availability
GMP Inspection
Report Date &
Remarks
Previous DRB
Decision /
Remarks
(if any)
249. M/s Hiranis
Pharmaceuticals
Pvt Ltd. Plot
No.E-145 to E-
149, Port Qasim,
Karachi
Etoxib 90mg tablets
Each film coated tablet
contains:
Etoricoxib……90mg
COX-2 Inhibitor
Dy. 42314
Form-5-D
10’s- Rs.630
14’s-Rs.870
20’s-Rs.1260
11-12-2018
Rs.50,000
11-12-2018
MHRA Approved
7-9-2017 Overall
GMP compliance
is found at
satisfactory level.
Manufacturer’s
Specifications.
STABILITY STUDY DATA
Drug Etoxib 90mg tablets
Name of Manufacturer M/s Hiranis Pharmaceuticals Pvt Ltd. Plot No.E-145 to E-149, Port Qasim,
Karachi
Manufacturer of API M/s Glenmark, Maharashtra, India
API Lot No. Batch No. 84170430
Description of Pack Alu/Alu packing
Minutes of 294th Meeting of Registration Board | 235
(Container closure system)
Stability Storage Condition Accelerated: 40°C ± 2°C & 75±5%RH
Real Time: 30°C ± 2°C & 65±5%RH
Time Period Accelerated: 6Months
Real Time: 6Months
Frequency Accelerated: Initial,1,3,6(Months)
Real Time: Initial, 1,3,6 (Month)
Batch No. TF-050418 TF-060418 TF-070418
Batch Size 2500 Tablets 2500 Tablets 2500 Tablets
Manufacturing Date 04-2018 04-2018 04-2018
Date of Initiation 04-2018 04-2018 04-2018
No. of Batches 03
Date of Submission Dairy 42314, 11-12-2018
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr. Documents To Be Provided Status
1. COA of API COA from M/s Glenmark, Maharashtra, India is
attached.
2. Approval of API by regulatory authority of country
of origin or GMP certificate of API manufacturer
issued by regulatory authority of country of origin.
GMP certificate issued from Food and Drug
Administration Bandra-Kurla Complex, Mumbai,
Maharashtara, India that is valid upto 24-5-2021
3. Protocols followed for conduction of stability study
and details of tests.
Yes
4. Data of 03 batches will be supported by attested
respective documents like chromatograms,
laboratory reports, data sheets etc.
Yes
5. Documents confirming import of API etc. Yes
6. All provided documents will be attested (name, sign
and stamp) for ensuring authenticity of data /
documents.
Yes
7. Commitment to continue real time stability study till
assigned shelf life of the product.
Yes
8. Commitment to follow Drug Specification Rules,
1978.
Yes
REMARKS OF EVALUATOR(VI)
The panel is requested to evaluate the addition of 5% overage in the finish product stability batches.
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Etoxib 90mg
and 120mg (Etoricoxib) Tablets by M/s Hiranis Pharmaceuticals Pvt. Ltd., Plot # E-145 to E-149, Port
Qasim, Karachi.
Reference No: F.13-11/2017-PEC (Vol.I) dated 25th April, 2019.
Investigation Date and Time: 29th October, 2019 (Morning).
Investigation Site: Factory premises of M/s. Hiranis Pharmaceuticals Pvt. Ltd., Plot # E-145 to E-149, Port
Qasim, Karachi.
Background:
Chairman Registration Board considered the applications of M/s. Hiranis Pharmaceuticals Pvt. Ltd., Plot # E-145
to E-149, Port Qasim, Karachi for registration of Etoxib 90mg and 120mg (Etoricoxib) Tablets and constituted a
Minutes of 294th Meeting of Registration Board | 236
three member panel to investigate the authenticity/genuineness of data (import of raw material and stability data).
Panel was advised to conduct inspection of the firm and to submit report for further consideration.
Composition of Panel:
1. Dr. Ghulam Sarwar, Dean, Faculty of Pharmacy, Jinnah University for Women, Karachi. (Member
Registration Board) Islamabad.
2. Dr. Saif ur Rehman Khattak, Director, CDL, DRAP, Karachi.
3. Mr. Kirshan Das, Assistant Director, DRAP Office, Karachi.
Scope of investigation:
Investigation of the authenticity / genuineness of data (import of raw material and stability data), manufacturing
of stability batches and stability studies on these batches.
Tools for Investigation:
The investigation was conducted by using a structured questionnaire of DRAP. For objective evidence physical
inspection of the facilities for manufacturing and quality control, material used and retained, personnel involved,
ongoing studies, printed data and integrity and security of data in respective databases were also audited. The
details of investigation may be summarized as under:
ETOXIB 90mg & 120mg TABLETS
Q.# Question Observation by panel
1. Do you have documents confirming the
import of Etoricoxib API including
approval from DRAP?
The firm has used Etoricoxib API for manufacturing of
stability batches of Etoxib 90mg & 120mg tablets from
50kg commercial consignment imported form M/s
Glenmark Pharmaceuticals Ltd, India and has approval
from DRAP for import vide License No.0111/17-DRAP
(K) dated 11.01.2017.
2. What was the rationale behind
selecting the particular manufacturer of
API?
There is proper vendor evaluation process being
implemented by the firm including Postal Audit checklist,
API stability reports and availability of valid GMP approval
by competent authority.
Etoricoxib is the approved API of the firm and regularly
procuring it for the manufacture of their registered and
marketed product ‘Etoxib Tablets 60mg’.
3. Do you have documents confirming the
import of Etoricoxib reference standard
and impurity standards?
Firm has imported Etoricoxib reference standard from M/s
Glenmark Pharmaceuticals Ltd, India vide invoice No.
F200E002064 dated 28.09.2017 and invoice No.
F20000002385 dated 23.02-2018 from M/s Glenmark
Pharmaceuticals Ltd, India. The firm has also imported
reference standard of the API from M/s. Sigma Aldrich,
USA. As per API manufacturer DMF there is no non
impurity.
4. Do you have certificate of Analysis of
the API, reference standards and
impurity standards?
The firm has certificates of analysis for API and reference
standard of the API.
5. Do you have GMP certificate of API
manufacturer issued by regulatory
authority of country of origin?
Firm has provided copy of valid GMP certificate of M/s
Glenmark Pharmaceuticals Ltd, India valid till 10-02-2020.
6. Do you use API manufacturer method
of testing for testing API?
The firm has used API manufacturer’s method of testing.
7. Do you have stability studies reports on
API?
The firm has stability studies reports on API.
Minutes of 294th Meeting of Registration Board | 237
8. If yes, whether the stability testing has
been performed as per SIM method and
degradation products have been
quantified?
The stability testing has been performed as per SIM method
however; no specific degradation product has been
mentioned / monitor in the stability reports.
9. Do you have method for quantifying
the impurities in the API?
The firm has performed area normalization method for
quantifying the impurities (any unknown impurities).
10. Do you have some remaining quantities
of the API, its reference standard and
impurities standards?
The firm has some remaining quantities of the API and
Working standard of the API.
11. Have you used pharmaceutical grade
excipients?
The firm have used pharmaceutical grade excipients which
include Microcrystalline Cellulose (Avicel PH-102),
Dibasic Calcium Hydrogen Phosphate Anhydrous,
Croscarmellose Sodium, Colloidansilicon dioxide (Aerosil
200), Purified Talk and Magnesium Stearate. Film coating
materials include Sheff Coat PVA + White 5Y00089 for
Etoxib 120mg tablets and Sheff Coat PVA + White
5Y00089 + Lake Brilliant Blue FCF (C.1.No.42090-1) for
Etoxib 90mg Tablets.
12. Do you have documents confirming the
import of the used excipients?
The firm has necessary documents confirming the import of
the used excipients.
13. Do you have test reports and other
records on the excipients used?
The firm has test reports and other records on the excipients
used.
14. Do you have written and authorized
protocols for the development of
Etoricoxib tablets?
The firm has written and authorized protocols for the
development of Etoricoxib Tablets 90mg & 120mg.
15. Have you performed Drug-excipient
compatibility studies?
Since firm has used same excipients as used by the
innovator. Therefore, compatibility studies have not been
performed.
16. Have you performed comparative
dissolution studies?
The firm has performed Comparative Studies with
Arcoxia Tablets 90mg Batch no. M022039
Arcoxia Tablets 120mg Batch no. M045935
Manufactured by M/s Merck Sharp & Dohme Limited,
Hertford Road, Hoddesdon, Hertfordshire EN 11 98U, UK.
The firm’s products (Etoricoxib Tablets 90mg & 120mg)
show comparable dissolution profile with innovator product
Arcoxia Tablets 90mg & 120mg.
17. Do you have product development
(R&D) section?
The firm has dedicated product development (R&D) section
with requisite manufacturing equipments whereas testing
facilities are performed in the QC laboratory for routine
testing.
18. Do you have necessary equipment
available in product development
section for development of Etoricoxib
tablets?
The firm has necessary equipment available in product
development section for development of Etoricoxib Tablets
90mg & 120mg.
19. Are the equipment in product
development section qualified?
The available equipment in product development section
are qualified.
20. Do you have proper maintenance /
calibration / re-qualification program
for the equipment used in PD section?
The firm has proper maintenance / calibration with re-
qualification program for the equipment used in PD section.
21. Do you have qualified staff in product
development section with proper
The firm has qualified staff in product development section
with proper knowledge and training in product
development. 02 Pharmacists working in R&D Section.
Minutes of 294th Meeting of Registration Board | 238
knowledge and training in product
development?
22. Have you manufactured three stability
batches for the stability studies of
Etoricoxib tablets as required?
The firm has manufactured three stability batches of
Etoricoxib Tablets 90mg & 120mg. Packed in Alu-Alu
blisters:
Etoricoxib Tablets 90mg
Batch No. Date of Mfg. Batch Size
TF050418 April 2018 2500 Tablets
TF060418 April 2018 2500 Tablets
TF070418 April 2018 2500 Tablets
Etoricoxib Tablets 120mg
Batch No. Date of Mfg. Batch Size
TF020418 April 2018 2500 Tablets
TF030418 April 2018 2500 Tablets
TF040418 April 2018 2500 Tablets
23. Do you have any criteria for fixing the
batch size of stability batches?
The criteria for fixing the batch size of stability batches is
the capacity of their R&D equipment where probable
simulation of manufacturing procedure of production
batches is expected as well as quantity of tablets required
per testing frequencies.
24. Do you have complete record of
production of stability batches?
The firm has complete record of production of stability
batches. All the Log Books are properly maintained.
25. Do you have protocols for stability
testing of stability batches?
The firm has detailed protocols for stability testing of
stability batches having protocol number:
Etoricoxib Tablets 90mg
Batch No. Protocol No.
TF050418 QCS-0504-18
TF060418 QCS-0604-18
TF070418 QCS-0704-18
Etoricoxib Tablets 120mg
Batch No. Protocol No.
TF020418 QCS-0204-18
TF030418 QCS-0304-18
TF040418 QCS-0404-18
26. Do you have developed and validated
the method for testing of stability
batches?
The firm has developed and validated the method for testing
of stability batches based on the API manufacturer method
for testing the API supported by forced degradation study.
27. Do you have method transfer studies in
case when the method of testing being
used by your firm is given by any other
lab?
The firm has developed and validated method of testing for
finished product and complete Method Validation Report is
available.
28. Do you have documents confirming the
qualification of equipments /
instruments being used in the test and
analysis of Etoricoxib API and the
finished drug?
The firm has proper documents confirming the qualification
of equipment / instruments being used in the test and
analysis of Etoricoxib API and the finished drug.
29. Do your method of analysis stability
indicating?
The firm has performed forced degradation (FD) study on
their product Etoricoxib Tablets 90mg & 120mg for the
conformance of its stability indicating nature.
30. Do your HPLC software 21CFR
Compliant?
The HPLC software is 21CFR Compliant as per record
available with the firm.
Minutes of 294th Meeting of Registration Board | 239
31. Can you show Audit trail reports on
Etoricoxib testing?
Audit trail on the testing reports is available.
32. Do you have some remaining quantities
of degradation products and stability
batches?
The firm has remaining quantities of stability batches only.
33. Do you have stability batches kept on
stability testing?
The firm has three stability batches kept on real time
stability testing.
34. Do you have valid calibration status for
the equipments used in Etoricoxib
tablets production and analysis?
The firm has valid calibration status for the equipment used
in production and analysis of Etoricoxib Tablets 90mg &
120mg.
35. Do proper and continuous monitoring
and control are available for stability
chamber?
Adequate monitoring and control are available for stability
chamber. Chambers are controlled and monitored through
software having alarm system for alerts as well.
36. Do related manufacturing area,
equipment, personnel and utilities be
rated as GMP compliant?
Related manufacturing area, equipment, personnel and
utilities are GMP compliant.
37. Any Comments?
Evaluation of the addition of 5%
overage in the finish product stability
batches.
The firm presented the following justification before the
inspection panel which has already been submitted to
Islamabad vide letter No. Nil dated 07-02-2019.
The same statement has been refreshed in letter No. Nil
dated 30-10-2019 (copy enclosed) which states as under:
In master formulation of above product 5% overage had
been added. This addition was not due to any specific reason
and we commit that in commercial batch formulation 5%
overage will not be included. Furthermore, it is stated that
Etoxib tablet (Etoricoxib) 60mg is our registered product
having Reg. No. 073741 and we are not using any overage
in this product. The same was also verified by the panel
member at the time of inspection.
Conclusions:
1. On the basis of risk-based approach the genuineness / authenticity of stability data submitted by the firm
for registration of Etoxib (Etoricoxib) 90mg & 120mg Tablets is verifiable to satisfactory level.
2. The related manufacturing area, equipment, personnel and utilities are GMP compliant and well suited
for the manufacturing of Etoxib 90mg & 120mg Tablets.
Recommendations:
1. The firm may kindly be granted necessary registration of Etoxib 90mg & 120mg tablets.
Decision of 293rd meeting of Registration Board:
Registration Board decided to defer the case of Etoxib 90mg & Etoxib 120mg tablets and directed the firm to
submit dissolution testing data with specifications of “NLT Q within 15 minutes” at initial and one month time
point at both accelerated and real time stability conditions for 2 batches.
Response by the firm and Evaluation of PEC:
In accordance to directives of Registration Board meeting minutes, the firm has conducted dissolution test in 15
minutes of stability batches after 22 months at real time storage condition and 01 month at accelerated stability
condition. The dissolution results at both real time as well as accelerated conditions fall within acceptable range
as per the revised dissolution specifications of the firm i.e. NLT 75%(Q) in 15 minutes.
Decision: Registration Board decided to approve registration of Etoxib 90mg tablets & Etoxib
120mg tablets with Innovator’s specifications by M/s Hiranis Pharmaceuticals Pvt. Ltd., Plot # E-
145 to E-149, Port Qasim, Karachi. Manufacturer will place first three production batches on long
term stability studies throughout proposed shelf life and on accelerated studies for six months.
Minutes of 294th Meeting of Registration Board | 240
Sr.
No.
Name & Address of
Manufacturer /
Applicant
Brand Name
(Proprietary Name + Dosage
Form + Strength), Composition,
Pharmacological Group,
Finished Product Specification
Type of Form,
Initial Diary &
Date, Fee (including
differential fee),
Demanded Price /
Pack size
International Availability /
Local Availability
GMP Inspection Report Date &
Remarks
250. M/s The Searle
Company Limited,
F-319, S.I.T.E.,
Karachi
Sacusar Tablets 97/103mg
Each Film Coated Tablet
Contains:
Sacubitril ….…97mg
Valsartan …… 103mg
Anti-hypertensive
In-house specifications
Form 5D
Dy. No 14655
dated
7-03-2019
Rs. 50,000/- dated
06-03-2019,
As per SRO
Approved by USFDA
The firm was inspected on
27.06.2018, wherein the GMP
of the firm was rated good.
STABILITY STUDY DATA
Drug Sacusar 97/103mg Tablets
Name of Manufacturer M/s The Searle Company Limited, F-319, S.I.T.E., Karachi
Manufacturer of API M/s Zhuhai Rundu Pharmaceuticals Co. Ltd, Guangdong,519041,
China
API Lot No. 57318060103
Description of Pack
(Container closure system)
Alu Alu Blisters 2x 10’s in unit carton
Stability Storage Condition Accelerated: 40°C ± 2°C & 75±5%RH
Real Time: 30°C ± 2°C & 75±5%RH
Time Period Accelerated: 06 Months Real Time: 06 Months
Frequency Accelerated: 0,3,6 (Months) Real Time: 0,3,6 (Month)
Batch No. 19PD-066 19PD-071 19PD-072
Batch Size 2500 Tablets 2500 Tablets 2500 Tablets
Manufacturing Date Mar-2019 Mar-2019 Mar-2019
Date of Initiation Mar-2019 Mar-2019 Mar-2019
No. of Batches 03
Date of Submission
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr.# Documents To Be Provided Status
1. COA of API COA of both API’s manufacturer (Lot NO:
57318060103) and Finished product manufacturer has
been provided.
2. Approval of API by regulatory authority of
country of origin or GMP certificate of API
manufacturer issued by regulatory authority of
country of origin.
GMP certificate for API manufacturing issued from
Zhuhai Food and Drug Administration and is valid till
21/12/2021
3. Protocols followed for conduction of stability
study and details of tests.
Yes
4. Data of 03 batches will be supported by attested
respective documents like chromatograms,
laboratory reports, data sheets etc.
Yes
Minutes of 294th Meeting of Registration Board | 241
5. Documents confirming import of API etc. The firm has submitted copy of commercial invoice for
the purchase of API’s (4.5Kg) attested by ADC, DRAP
Karachi dated 07-08-2018.
6. All provided documents will be attested (name,
sign and stamp) for ensuring authenticity of data
/ documents.
Yes
7. Commitment to continue real time stability study
till assigned shelf life of the product.
Yes
8. Commitment to follow Drug Specification
Rules, 1978.
Yes
EXEMPTION DATA SUBMITTED AS PER 293RD MEETING OF REGISTRATION BOARD
Check List Firm’ Response
1. Reference of previous approval of
applications with stability study data of
the firm
Firm has referred to last onsite inspection report of their product
“Ticor 60mg & 90mg Tablets”, which was presented in 293rd
meeting of Registration board. Registration Board decided to
approve registration of above stated drug product of M/s The
Searle company Ltd., Karachi.
Date of inspection: 11th March-2019
According to inspection report, following points were
confirmed.
The HPLC software of the firm is 21 CRF compliant.
The firm has installed software for adequate monitoring and
control of temperature / humidity of the chamber.
2. Certificate of Analysis of API from both
API Manufacturer and Finished Product
manufacturer.
COA of both API’s manufacturer (Lot NO:- 57318060103 ) and
Finished product manufacturer has been provided.
3. Method used for analysis of API from
both API Manufacturer and Finished
Product
manufacturer
The firm has submitted Raw Material Specifications, Raw
Material Testing Procedures along with COAs
4. Stability study data of API from API
manufacturer
M/s Zhuhai Rundu Pharmaceuticals has performed accelerated
stability studies for 6 months at 40’C and 75% for 3 batches and
real time stability studies for 12 months at 30’C/75% for 3
batches.
5. Approval of API/ DML/GMP certificate
of API manufacturer issued by
concerned regulatory authority of
country of origin.
GMP certificate for API manufacturing issued from Zhuhai
Food and Drug Administration and is valid till 21/12/2021
6. Documents for the procurement of API
with approval from DRAP (in case of
import).
The firm has submitted copy of commercial invoice for the
purchase of API’s (4.5Kg) attested by ADC, DRAP Karachi
dated 07-08-2018.
7. Protocols followed for conduction of
stability study
The firm has submitted protocol for the conduction of stability
studies.
8. Method used for analysis of FPP The firm has submitted copy of Finished Product Testing
Procedure along with Stability Study Reports.
9. Drug-excipients compatibility studies
(where applicable)
Firm has stated that our excipients are in-line with the
innovator’s, therefore we did not perform the studies
10. Complete batch manufacturing record of
three stability batches.
The firm has submitted complete batch manufacturing record of
the three batches.
Minutes of 294th Meeting of Registration Board | 242
11. Record of comparative dissolution data
(where applicable)
The firm has performed comparative dissolution studies in three
media including pH 1.2, pH 4.5 and pH 6.8 buffers with
Entresto Tablets. The firm‘s product results are comparable to
that of the comparator product.
12. Data of 03 batches will be supported by
attested respective documents like
chromatograms, Raw data sheets, COA,
summary data sheets etc.
Data of 03 batches will be supported by attested respective
documents like chromatograms, Raw data sheets, COA,
summary data sheets was submitted
13. Compliance Record of HPLC software
21CFR & audit trail reports on product
testing.
Audit trail on testing reports of Sacubitril/Valsartan from has
been submitted by the firm.
14. Record of Digital data logger for
temperature and humidity monitoring of
stability chambers(real time and
accelerated)
Record of Digital data logger for temperature and humidity
monitoring of stability chambers (real time and accelerated) has
been submitted
Remarks of the Evaluator:
The firm has performed dissolution as per the USFDA dissolution acceptance criteria i.e.
Apparatus Speed Volume Medium Detection Acceptance
Criteria
USP-II 50 rpm 900ml Phosphate
Buffer, pH 6.8
HPLC/UV
Wavelength=255nm
Q= __% at
25minutes
Decision: Registration Board decided to approve registration of Sacusar Tablets 97/103mg with
Innovator’s specifications by M/s The Searle Company Limited, F-319, S.I.T.E., Karachi.
Manufacturer will place first three production batches on long term stability studies throughout
proposed shelf life and on accelerated studies for six months.
Sr. No.
Name & Address
of Manufacturer /
Applicant
Brand Name
(Proprietary Name + Dosage
Form + Strength), Composition,
Pharmacological Group,
Finished Product Specification
Type of Form,
Initial Diary & Date,
Fee (including
differential fee),
Demanded Price / Pack
size
International
Availability / Local
Availability
GMP Inspection
Report Date &
Remarks
251. M/s The Searle
Company Limited,
F-319, S.I.T.E.,
Karachi
Sacusar Tablets 24/26mg
Each Film Coated Tablet
Contains:
Sacubitril ….…24mg
Valsartan …… 26mg
Anti-hypertensive
In-house specifications
Form 5D
Dy. No 14656 dated
7-03-2019
Rs. 50,000/- dated
06-03-2019,
As per SRO
Approved by USFDA
The firm was
inspected on
27.06.2018, wherein
the GMP of firm was
rated good.
STABILITY STUDY DATA
Drug Sacusar 24/26mg Tablets
Name of Manufacturer M/s The Searle Company Limited, F-319, S.I.T.E., Karachi
Manufacturer of API M/s Zhuhai Rundu Pharmaceuticals Co. Ltd, Guangdong,519041, China
API Lot No. 57318060103
Description of Pack
(Container closure system)
Alu Alu Blisters 2x 10’s in unit carton
Stability Storage Condition Accelerated: 40°C ± 2°C & 75±5%RH
Real Time: 30°C ± 2°C & 75±5%RH
Time Period Accelerated: 06 Months Real Time: 06 Months
Frequency Accelerated: 0,3,6 (Months) Real Time: 0,3,6 (Month)
Minutes of 294th Meeting of Registration Board | 243
Batch No. 18PD-281 18PD-287 18PD-288
Batch Size 2000 Tablets 2000 Tablets 2000 Tablets
Manufacturing Date Nov-2018 Dec-2018 Dec-2018
Date of Initiation Dec-2018 Jan-2019 Jan-2019
No. of Batches 03
Date of Submission
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr.# Documents To Be Provided Status
1. COA of API COA of both API’s manufacturer (Lot NO:-
57318060103 ) and Finished product manufacturer has
been provided.
2. Approval of API by regulatory authority of
country of origin or GMP certificate of API
manufacturer issued by regulatory authority of
country of origin.
GMP certificate for API manufacturing issued from
Zhuhai Food and Drug Administration and is valid till
21/12/2021
3. Protocols followed for conduction of stability
study and details of tests.
Yes
4. Data of 03 batches will be supported by attested
respective documents like chromatograms,
laboratory reports, data sheets etc.
Yes
5. Documents confirming import of API etc. The firm has submitted copy of commercial invoice for
the purchase of API’s (4.5Kg) attested by ADC, DRAP
Karachi dated 07-08-2018.
6. All provided documents will be attested (name,
sign and stamp) for ensuring authenticity of
data / documents.
Yes
7. Commitment to continue real time stability
study till assigned shelf life of the product.
Yes
8. Commitment to follow Drug Specification
Rules, 1978.
Yes
EXEMPTION DATA SUBMITTED AS PER 293RD MEETING OF REGISTRATION BOARD
Check List Firm’ Response
1. Reference of previous approval of
applications with stability study data of the
firm
Firm has referred to last onsite inspection report of their
product “Ticor 60mg & 90mg Tablets”, which was presented
in 293rd meeting of Registration board. Registration Board
decided to approve registration of above stated drug product
of M/s The Searle company Ltd., Karachi.
Date of inspection: 11th March-2019
According to inspection report, following points were
confirmed.
The HPLC software of the firm is 21 CRF compliant.
The firm has installed software for adequate monitoring and
control of temperature / humidity of the chamber.
2. Certificate of Analysis of API from both
API Manufacturer and Finished Product
manufacturer.
COA of both API’s manufacturer (Lot NO:- 57318060103 )
and Finished product manufacturer has been provided.
Minutes of 294th Meeting of Registration Board | 244
3. Method used for analysis of API from both
API Manufacturer & Finished Product
manufacturer
The firm has submitted Raw Material Specifications, Raw
Material Testing Procedures along with COAs
4. Stability study data of API from API
manufacturer
M/s Zhuhai Rundu Pharmaceuticals has performed
accelerated stability studies for 6 months at 40’C and 75%
for 3 batches and real time stability studies for 12 months at
30’C/75% for 3 batches.
5. Approval of API/ DML/GMP certificate of
API manufacturer issued by concerned
regulatory authority of country of origin.
GMP certificate for API manufacturing issued from Zhuhai
Food and Drug Administration and is valid till 21/12/2021
6. Documents for the procurement of API with
approval from DRAP (in case of import).
The firm has submitted copy of commercial invoice for the
purchase of API’s (4.5Kg) attested by ADC, DRAP Karachi
dated 07-08-2018.
7. Protocols followed for conduction of
stability study
The firm has submitted protocol for the conduction of
stability studies.
8. Method used for analysis of FPP The firm has submitted copy of Finished Product Testing
Procedure along with Stability Study Reports.
9. Drug-excipients compatibility studies
(where applicable)
Firm has stated that our excipients are in-line with the
innovator’s, therefore we did not perform the studies
10. Complete batch manufacturing record of
three stability batches.
The firm has submitted complete batch manufacturing record
of the three batches.
11. Record of comparative dissolution data
(where applicable)
The firm has performed comparative dissolution studies in
three media including pH 1.2, pH 4.5 and pH 6.8 buffers with
Entresto Tablets. The firm‘s product results are comparable
to that of the comparator product.
12. Data of 03 batches will be supported by
attested respective documents like
chromatograms, Raw data sheets, COA,
summary data sheets etc.
Data of 03 batches will be supported by attested respective
documents like chromatograms,
Raw data sheets, COA, summary data sheets was submitted
13. Compliance Record of HPLC software
21CFR & audit trail reports on product
testing.
Audit trail on testing reports of Sacubitril/Valsartan from has
been submitted by the firm.
14. Record of Digital data logger for
temperature and humidity monitoring of
stability chambers (real time/accelerated)
Record of Digital data logger for temperature and humidity
monitoring of stability chambers (real time and accelerated)
has been submitted
Remarks of the Evaluator:
The firm has performed dissolution as per the USFDA dissolution acceptance criteria i.e.
Apparatus Speed Volume Medium Detection Acceptance
Criteria
USP-II 50 rpm 900ml Phosphate
Buffer, pH 6.8
HPLC/UV
Wavelength=255nm
Q= __% at
25minutes
Decision: Registration Board decided to approve registration of Sacusar Tablets 24/26mg with
Innovator’s specifications by M/s The Searle Company Limited, F-319, S.I.T.E., Karachi.
Manufacturer will place first three production batches on long term stability studies throughout
proposed shelf life and on accelerated studies for six months.
Minutes of 294th Meeting of Registration Board | 245
Sr. No.
Name & Address of
Manufacturer /
Applicant
Brand Name
(Proprietary Name + Dosage
Form + Strength),
Composition,
Pharmacological Group,
Finished Product Specification
Type of Form,
Initial Diary & Date,
Fee (including
differential fee),
Demanded Price /
Pack size
International Availability
/ Local Availability
GMP Inspection Report
Date & Remarks
252. M/s The Searle
Company Limited,
F-319, S.I.T.E.,
Karachi
Sacusar Tablets 49/51mg
Each film coated tablet
Contains:
Sacubitril ….…49mg
Valsartan …… 51mg
Anti-hypertensive
In-house specifications
Form 5D
Dy. No 14657 dated
7-03-2019
Rs. 50,000/- dated
06-03-2019,
As per SRO
Approved by USFDA
The firm was inspected
on 27.06.2018, wherein
the GMP of the firm was
rated good.
STABILITY STUDY DATA
Drug Sacusar 49/51mg Tablets
Name of Manufacturer M/s The Searle Company Limited, F-319, S.I.T.E., Karachi
Manufacturer of API M/s Zhuhai Rundu Pharmaceuticals Co. Ltd, Guangdong,519041, China
API Lot No. 57318060103
Description of Pack
(Container closure system)
Alu Alu Blisters 2x 10’s in unit carton
Stability Storage Condition Accelerated: 40°C ± 2°C & 75±5%RH
Real Time: 30°C ± 2°C & 75±5%RH
Time Period Accelerated: 06 Months
Real Time: 06 Months
Frequency Accelerated: 0,3,6 (Months)
Real Time: 0,3,6 (Month)
Batch No. 19PD-011 19PD-056 19PD-246
Batch Size 2500 Tablets 2500 Tablets 2500 Tablets
Manufacturing Date Jan-2019 Feb-2019 Feb2019
Date of Initiation Feb-2019 Mar-2019 Mar-2019
No. of Batches 03
Date of Submission
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr.# Documents To Be Provided Status
1. COA of API COA of both API’s manufacturer (Lot NO:-
57318060103 ) and Finished product manufacturer has
been provided.
2. Approval of API by regulatory authority of
country of origin or GMP certificate of API
manufacturer issued by regulatory authority of
country of origin.
GMP certificate for API manufacturing issued from
Zhuhai Food and Drug Administration and is valid till
21/12/2021
3. Protocols followed for conduction of stability
study and details of tests.
Yes
4. Data of 03 batches will be supported by attested
respective documents like chromatograms,
laboratory reports, data sheets etc.
Yes
Minutes of 294th Meeting of Registration Board | 246
5. Documents confirming import of API etc. The firm has submitted copy of commercial invoice for
the purchase of API’s (4.5Kg) attested by ADC, DRAP
Karachi dated 07-08-2018.
6. All provided documents will be attested (name,
sign and stamp) for ensuring authenticity of data
/ documents.
Yes
7. Commitment to continue real time stability study
till assigned shelf life of the product.
Yes
8. Commitment to follow Drug Specification Rules,
1978.
Yes
EXEMPTION DATA SUBMITTED AS PER 293RD MEETING OF REGISTRATION BOARD
Check List Firm’ Response
1. Reference of previous approval of
applications with stability study data of
the firm
Firm has referred to last onsite inspection report of their product
“Ticor 60mg & 90mg Tablets”, which was presented in 293rd
meeting of Registration board. Registration Board decided to
approve registration of above stated drug product of M/s The
Searle company Ltd., Karachi.
Date of inspection: 11th March-2019
According to inspection report, following points were
confirmed.
The HPLC software of the firm is 21 CRF compliant.
The firm has installed software for adequate monitoring and
control of temperature / humidity of the chamber.
2. Certificate of Analysis of API from both
API Manufacturer & Finished Product
manufacturer.
COA of both API’s manufacturer (Lot NO: 57318060103) and
Finished product manufacturer has been provided.
3. Method used for analysis of API from
both API Manufacturer and Finished
Product
manufacturer
The firm has submitted Raw Material Specifications, Raw
Material Testing Procedures along with COAs
4. Stability study data of API from API
manufacturer
M/s Zhuhai Rundu Pharmaceuticals has performed accelerated
stability studies for 6 months at 40’C and 75% for 3 batches and
real time stability studies for 12 months at 30’C/75% for 3
batches.
5. Approval of API/ DML/GMP certificate
of API manufacturer issued by
concerned regulatory authority of
country of origin.
GMP certificate for API manufacturing issued from Zhuhai
Food and Drug Administration and is valid till 21/12/2021
6. Documents for the procurement of API
with approval from DRAP (in case of
import).
The firm has submitted copy of commercial invoice for the
purchase of API’s (4.5Kg) attested by ADC, DRAP Karachi
dated 07-08-2018.
7. Protocols followed for conduction of
stability study
The firm has submitted protocol for the conduction of stability
studies.
8. Method used for analysis of FPP The firm has submitted copy of Finished Product Testing
Procedure along with Stability Study Reports.
9. Drug-excipients compatibility studies
(where applicable)
Firm has stated that our excipients are in-line with the
innovator’s, therefore we did not perform the studies
10. Complete batch manufacturing record
of three stability batches.
The firm has submitted complete batch manufacturing record of
the three batches.
Minutes of 294th Meeting of Registration Board | 247
11. Record of comparative dissolution data
(where applicable)
The firm has performed comparative dissolution studies in three
media including pH 1.2, pH 4.5 and pH 6.8 buffers with
Entresto Tablets. The firm‘s product results are comparable to
that of the comparator product.
12. Data of 03 batches will be supported by
attested respective documents like
chromatograms, Raw data sheets, COA,
summary data sheets etc.
Data of 03 batches will be supported by attested respective
documents like chromatograms,
Raw data sheets, COA, summary data sheets was submitted
13. Compliance Record of HPLC software
21CFR & audit trail reports on product
testing.
Audit trail on testing reports of Sacubitril/Valsartan from has
been submitted by the firm.
14. Record of Digital data logger for
temperature and humidity monitoring of
stability chambers (real time and
accelerated)
Record of Digital data logger for temperature and humidity
monitoring of stability chambers (real time and accelerated) has
been submitted
Remarks of the Evaluator:
The firm has performed dissolution as per the USFDA dissolution acceptance criteria i.e.
Apparatus Speed Volume Medium Detection Acceptance
Criteria
USP-II 50 rpm 900ml Phosphate
Buffer, pH 6.8
HPLC/UV
Wavelength=255nm
Q= __% at
25minutes
Decision: Decision: Registration Board decided to approve registration of Sacusar Tablets
49/51mg with Innovator’s specifications by M/s The Searle Company Limited, F-319, S.I.T.E.,
Karachi. Manufacturer will place first three production batches on long term stability studies
throughout proposed shelf life and on accelerated studies for six months.
Minutes of 294th Meeting of Registration Board | 248
Item No. 8: Agenda of Evaluator PEC-VIII
Case No. 01 Registration applications of newly granted DML or New section (Veterinary)
a. New DML /section On recommendation of panel of experts CLB in its 271st meeting held on 12th September, 2019 has considered
& approved following six additional section of M/s. Grand Pharma:
1. Bolus section (general)(veterinary)
2. Oral Powder section (general)(veterinary)
3. Oral Liquid section (general)(veterinary)
4. Oral Powder section (penicillin)(veterinary)
5. Dry Powder Injection section Vials (penicillin)(veterinary)
6. Liquid Injection section Vials (penicillin)(veterinary)
Now the firm has applied for the following:
Sr.# Section No. Of Molecules No. Of Products
1 Oral Liquid section
(general)(veterinary)
10 10
2 Oral Powder section
(general)(veterinary)
7 7
Oral Liquid section (general)(veterinary): Molecules/Products considered: 07M/07P.
253. Name and address of manufacturer /
Applicant
M/s. Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5,
National Industrial Zone, Rawat, Rawalpindi
Brand Name+Dosage Form+Strength G-Flor Plus Oral Liquid
Composition "Each 100ml Contains:
Florfenicol…23gm
Colistin Sulphate…50 MIU"
Diary No. Date of R&I & Fee Dy.No 21148 dated 18-10-2019 Rs. 20,000
Pharmacological Group Antibiotic
Type of Form Form-5
Finished product Specification Manufacturer's Specification
Pack size & Demanded Price 500ml, 1liter, 2.5liter, 5liter; Decontrolled
Me-too status Maxiflor Plus Oral Liquid of BIOGEN Pharma (Reg# 075617).
Each 1000ml Contains:-
Florfenicol…………23gm
Colistin Sulphate...50 MIU
GMP status Oral Liquid section (general)(veterinary)Letter Issuance Date:
26th September, 2019. On recommendation of panel of experts
CLB in its 271st meeting held on 12th September, 2019 has
considered & approved following six additional section of M/s.
Grand Pharma:
1. Bolus section (general)(veterinary)
2. Oral Powder section (general)(veterinary)
3. Oral Liquid section (general)(veterinary)
4. Oral Powder section (penicillin)(veterinary)
5. Dry Powder Injection section Vials (penicillin)(veterinary)
6. Liquid Injection section Vials (penicillin)(veterinary)
Remarks of the Evaluator Evidence of applied formulation/drug already approved by
DRAP (generic / me-too status) alongwith registration number,
brand name & name of firm as provided evidence is of another
strength.
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic
/ me-too status) alongwith registration number, brand name and name of firm.
Minutes of 294th Meeting of Registration Board | 249
254. Name and address of manufacturer /
Applicant
M/s. Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5,
National Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Nor-Ct Oral Liquid
Composition "Each 100ml Contains:
Tylosin Tartrate…5gm
Norfloxacin…10gm
Colistin Sulphate…250 MIU"
Diary No. Date of R&I & Fee Dy.No 21149 dated 18-10-2019 Rs. 20,000
Pharmacological Group Antibiotic
Type of Form Form-5
Finished product Specification Manufacturer's Specification
Pack size & Demanded Price 500ml, 1liter, 2.5liter, 5liter; Decontrolled
Me-too status Norcotyl Oral Solution of BIOGEN Pharma (Reg# 071021)
Each 100ml contain:-
Norfloxacin…………10%
Colistin sulphate…250 MIU
Tylosin tartrate……..5%
GMP status Same as recorded for above application.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
255. Name and address of manufacturer /
Applicant
M/s. Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5,
National Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Brom Aid Oral Liquid
Composition "Each 1000ml Contains:
BromhexineHcl…50gm"
Diary No. Date of R&I & Fee Dy.No. 21151 dated 18-10-2019 Rs. 20,000
Pharmacological Group Expectorant / Mucolytic Agent
Type of Form Form-5
Finished product Specification Manufacturer's Specification
Pack size & Demanded Price 500ml, 1liter, 2.5liter, 5liter; Decontrolled
Me-too status Brombar-5 Oral Solution of BAARIQ Pharma (R# 073947)
Each ml contains:-
Bromhexine HCL….50mg
GMP status Same as recorded for above application.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
256. Name and address of manufacturer /
Applicant
M/s. Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5,
National Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Grand Tylcobrox Oral Liquid
Composition "Each ml Contains:
Tylosin Tartrate…200mg
Doxycycline Hcl…250mg
Colistin Sulphate…0.5 MIU
BromhexineHcl…12mg"
Diary No. Date of R&I & Fee Dy.No 21153 dated 18-10-2019 Rs. 20,000
Pharmacological Group Antibiotic / Expectorant
Type of Form Form-5
Finished product Specification Manufacturer's Specification
Pack size & Demanded Price 500ml, 1liter, 2.5liter, 5liter; Decontrolled
Me-too status Tylotar Fort Liquid of Evergreen Pharma (Reg# 078288).
EACH 1000ML CONTAINS:-
TYLOSIN TARTRATE BP…….200GM
DOXYCYCLINE HCL……….250GM
COLISTIN SULPHATE BP…500MIU
Minutes of 294th Meeting of Registration Board | 250
BROMHEXINE HCL BP…….12GM
GMP status Same as recorded for above application.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
257. Name and address of manufacturer /
Applicant
M/s. Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5,
National Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Grand Ivermec Drench Oral Liquid
Composition "Each ml Contains:
Ivermectin…1%"
Diary No. Date of R&I & Fee Dy.No 21154 dated 18-10-2019 Rs. 20,000
Pharmacological Group Antibiotic
Type of Form Form-5
Finished product Specification Manufacturer's Specification
Pack size & Demanded Price 500ml, 1liter, 2.5liter, 5liter; Decontrolled
Me-too status Ivosol Drench of BIOGEN PHARMA (Reg# 069608)
GMP status Same as recorded for above application.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
258. Name and address of manufacturer /
Applicant
M/s. Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5,
National Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Grand Td-400 Oral Liquid
Composition "Each 100ml Contains:
Tylosin Tartrate…20gm
Doxycycline Hcl…20gm"
Diary No. Date of R&I & Fee Dy.No. 21155 dated 18-10-2019 Rs. 20,000
Pharmacological Group Antibiotic
Type of Form Form-5
Finished product Specification Manufacturer's Specification
Pack size & Demanded Price 500ml, 1liter, 2.5liter, 5liter; Decontrolled
Me-too status Maxcin-400 Liquid of BIOGEN PHARMA (Reg# 058967)
GMP status Same as recorded for above application.
Remarks of the Evaluator
Decision: Approved with innovator’s specification.
259. Name and address of manufacturer /
Applicant
M/s. Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5,
National Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Enro-Hexin Oral Liquid Suspension
Composition "Each 100ml Contains:
Enrofloxacin…10gm
BromhexineHcl…1gm
Colistin Sulphate…55 MIU"
Diary No. Date of R&I & Fee Dy.No 21156 dated 18-10-2019 Rs. 20,000
Pharmacological Group Antibiotic / Expectorant
Type of Form Form-5
Finished product Specification Manufacturer's Specification
Pack size & Demanded Price 100ml, 500ml, 1liter; Decontrolled
Me-too status En-C-Raft Oral Liquid Of NAWAL PHARMA (Reg#
078251) (not verifiable)
GMP status Same as recorded for above application.
Remarks of the Evaluator Evidence of applied formulation/drug already approved by
DRAP (generic / me-too status) alongwith registration
number, brand name and name of firm as provided evidence
is of another strength, as provided Me Too is not verifiable.
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic /
me-too status) alongwith registration number, brand name and name of firm.
Minutes of 294th Meeting of Registration Board | 251
Oral Powder section (general)(veterinary): Molecules/Products considered: 05M/05P.
260. Name and address of manufacturer /
Applicant
Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National
Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Tylvotart Soluble Granules/Oral Dry Powder
Composition Each gm contains:
Acetyl IsovalerylTylosin Tartrate………...850 mg
Diary No. Date of R&I & Fee Dy. No. 21146 dated 18-10-2019 Rs. 20,000
Pharmacological Group Antibiotic
Type of Form Form-5
Finished product Specification Manufacturer's specification
Pack size & Demanded Price 25gm, 50gm, 100gm 500gm, 1kg, 2.5kg, 5kg; Decontrolled
Me-too status Aivlosin Soluble Granules1gm of Hilton Pharma
GMP status Oral Powder section (general)(veterinary) Letter Issuance
Date: 26th September, 2019.
Remarks of the Evaluator Submitted me-too status is of 1 gm strength.
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic /
me-too status) alongwith registration number, brand name and name of firm.
261. Name and address of manufacturer /
Applicant
Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National
Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Floron Oral Powder
Composition Each gram contains:
Neomycin Sulphate ….….....150 mg
Florfenicol……………………100 mg
Oxytetracycline hydrochloride….…300 mg
Diary No. Date of R&I & Fee Dy. No. 21143 dated 18-10-2019 Rs. 20,000
Pharmacological Group Aminoglycoside/Antibiotic
Type of Form Form-5
Finished product Specification Manufacturer's specification
Pack size & Demanded Price 0.5kg, 1kg, 2.5kg, 5kg; Decontrolled
Approval status of product in Reference
Regulatory Authority
N/A
Me-too status E.Col Oral Powder of Evergreen Pharma Registrtion No.
081733 (not verifiable)
GMP status Same as recorded for above application.
Remarks of the Evaluator Evidence of applied formulation/drug already approved by
DRAP (generic / me-too status) alongwith registration
number, brand name and name of firm, as the provided
evidence is not verifiable.
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic /
me-too status) alongwith registration number, brand name and name of firm.
262. Name and address of manufacturer /
Applicant
Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National
Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Grand TD Plus Oral Powder
Composition Each 100 gram contains:
Tylosin Tartrate……………….20 gm
Doxycycline Hyclate……………40 gm
Colistin Sulphate……………….10 gm
Bromhexin HCl………..………....2 gm
Diary No. Date of R&I & Fee Dy. No. 21141 dated 18-10-2019 Rs. 20,000
Pharmacological Group Antibiotic/ Expectorant
Type of Form Form-5
Finished product Specification Manufacturer's specification
Pack size & Demanded Price 0.5kg, 1kg, 2.5kg, 5kg; Decontrolled
Minutes of 294th Meeting of Registration Board | 252
Approval status of product in Reference
Regulatory Authority
N/A
Me-too status Tydoxin-60 Powder of Aptly Reg. 093862 (not veriofiable)
GMP status Same as recorded for above application.
Remarks of the Evaluator Evidence of applied formulation/drug already approved by
DRAP (generic/me-too status) alongwith registration
number, brand name and name of firm, as the provided
evidence is not verifiable.
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic / me-too status) alongwith registration number, brand name and name of firm.
263. Name and address of manufacturer / Applicant
Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Doxy-Hy 50 Oral Powder Composition Each kg contains:
Doxycycline Hyclate (BP)……..………500 gm
Diary No. Date of R&I & Fee Dy. No. 21140 dated 18-10-2019 Rs. 20,000 Pharmacological Group Antibiotic Type of Form Form-5
Finished product Specification Manufacturer's specification Pack size & Demanded Price 0.5kg, 1kg, 2.5kg, 5kg; Decontrolled Approval status of product in Reference Regulatory Authority
N/A
Me-too status Doxyvetz Oral Powder of M/s Vetz Pharma Reg. No.088059 (not verifiable)
GMP status Same as recorded for above application. Remarks of the Evaluator Evidence of applied formulation/drug already approved by
DRAP (generic / me-too status) alongwith registration number, brand name and name of firm, as the provided evidence is not verifiable.
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic / me-too status) alongwith registration number, brand name and name of firm.
264. Name and address of manufacturer / Applicant
Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Neocin 72% Oral Powder
Composition Each gram contains: Neomycin (as Sulphate) (BP)……….720 mg
Diary No. Date of R&I & Fee Dy. No. 21144 dated 18-10-2019 Rs. 20,000 Pharmacological Group Antibiotic
Type of Form Form-5 Finished product Specification Manufacturer's specification Pack size & Demanded Price 0.5kg, 1kg, 2.5kg, 5kg; Decontrolled
Approval status of product in Reference Regulatory Authority
N/A
Me-too status Neovetz 72% Of Vetz Pharma Reg. 079295 GMP status Same as recorded for above application.
Remarks of the Evaluator
Decision: Deferred for scientific rational for neomycin 72% water soluble powder, since neomycin 70% water soluble powder is already approved.
Case No. 02 Registration applications of drugs for which stability study data is submitted
a. Verification of stability study data 265. Name and address of manufacturer /
Applicant
M/s Zafa Pharmaceutical Laboratories, L-1/B, Block 22,
Federal “B” Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Sofosbuvir Tablet 400mg
Composition Each film coated tablet contains:
Sofosbuvir…. 400mg
Minutes of 294th Meeting of Registration Board | 253
Diary No. Date of R& I & fee R&I date: 27-08-2018
Fee 20,000/- (20-08-2018) Duplicate dossier
Pharmacological Group Anti-viral
Type of Form Form-5
Finished product Specifications Manufacturer’s specifications
Pack size & Demanded Price 28’s(HDPE bottle): As per PRC
Approval status of product in
Reference Regulatory Authorities
Approved in US-FDA
Me-too status (with strength and
dosage form)
N/A
STABILITY STUDY DATA
Drug Sofosbuvir Tablet 400mg
Name of Manufacturer M/s Zafa Pharmaceutical Laboratories, L-1/B, Block 22, Federal “B”
Industrial Area, Karachi.
Manufacturer of API Optimus Drugs PVT Limited,
Factory, Sy No. 239 & 240 Dothigudam(V) Pochampally(M), Nalgonda
Dist., Telangana, India
API Lot No. Batch No.OP-GLD/10/15/037
Description of Pack
(Container closure system) 28’s; HDPE Bottle
Stability Storage Condition Real Time: 30oC ± 2oC / 65% ± 5%RH
Accelerated:40oC ±2oC / 75% ± 5%RH
Time Period Real time: 6 months Accelerated: 6 months
Frequency Real Time: 0,4,8,12,24 Months Accelerated: 0,4,8,12,24 Months
Batch No. Tr-01 Tr-02 Tr-03
Batch Size 212 tablets 212 tablets 212 tablets
Manufacturing Date August, 2017 August, 2017 August, 2017
Date of Initiation 22th August, 2017 22th August, 2017 22th August, 2017
No. of Batches 03
Date of Submission 28-06-18
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr.# Documents To Be Provided Status
1. COA of API Firm has submitted copy of COA stating following
information on it:
Product:Sofosbuvir
Batch No.OP-GLD/10/15/037
Manufacturer:Optimus Drugs PVT Limited,
2. Approval of API by regulatory authority of
country of origin or GMP certificate of API
manufacturer issued by regulatory authority of
country of origin.
Applicant has submitted GMP certificate having
following information on it:
Certificate No.L.Dis.No.20121/A3/2018
Issued to:Optimus Drugs PVT Limited,
Issued on: 21-05-2018
Validity: One Year From The Date Of Issue
3. Protocols followed for conduction of stability
study and details of tests.
Yes
4. Data of 03 batches will be supported by attested
respective documents like chromatograms,
Yes
Minutes of 294th Meeting of Registration Board | 254
laboratory reports, data sheets etc.
5. Documents confirming import of API etc. Firm has submitted copy of commercial invoice stating
following information on it:
Invoice No. 412/EXP
Batch No of API. OP-GLD/10/15/037
Attested by Assistant Director (I & E) DRAP
Karachi On : 03-02-2016
6. All provided documents will be attested (name,
sign and stamp) for ensuring authenticity of data /
documents.
Yes
7. Commitment to continue real time stability study
till assigned shelf life of the product.
Yes
8. Commitment to follow Drug Specification Rules,
1978.
Yes
Evaluation by PEC:
SOFOSBUVIR TABLET 400MG, M/S ZAFA PHARMACEUTICALS LABORATORIES.
Following panel of inspectors visited M/s Zafa Pharmaceuticals Laboratories for verification of
authenticity of submitted stability study data for registration of Sofosbuvir 400mg Tablet.
1. Syed Adnan Rizvi Director, DTL, Karachi.
2. Dr. Najam-us-Saquib Additional Director DRAP, Karachi.
3. Kirshan, Assistant Director, DRAP, Karachi.
Q.No. Question Observation by panel
1.
Do you have documents confirming the
import of API including approval from
DRAP?
The firm has imported Sofosbuvir from Optimus Drug
Pvt. Ltd. Hyderabad INDIA, Supplier IRIS Karachi.
Invoice No.412/EXP dated 15-11-2015. Batch # OP-
GLD/10/15/037. The total quantityofAPI purchased
was1.00 kg.The approval from DRAP is available.
(Annex-A)
2.
What was the rationale behind selecting the
particular manufacturer of API?
Rationale behind selecting the particular manufacturer of
API, as it is GMP compliant and vendor evaluation has
been done. (Annex-B).
3.
Do you have documents confirming the
import of reference standard and impurity
standards?
The reference standard & impurity standard were
imported through Optimus Drug Pvt. Ltd. Hyderabad
INDIA. In House Reference standard, Batch # OP-
SFS/RS1402, quantity100mg.Impurity standard, Batch #
OP-GLD/St-I/Rp-Isomer/A0453/055, with quantity
10.0mg. (Annex-C)
4.
Do you have certificate of Analysis of the
API, reference standards and impurity
standards?
The firm has COAs for API, reference standards and
impurity.
5.
Do you have GMP certificate of API
manufacturer issued by regulatory authority
of country of origin?
The firm has GMP Certificate of API manufacturer
issued by Drug Control Administration Govt. of
Telangana INDIA.L.DisNo. 2021/A3/2018 Dated 21-
05-2018.
6. Do you use API manufacturer method of
testing for testing API?
The Firm has used manufacturer’s method of testing for
the testing of API.
7. Do you have stability studies reports on API? The firm has manufacturers Stability studies report of
API.
Minutes of 294th Meeting of Registration Board | 255
8.
If yes, whether the stability testing has been
performed as per SIM method and
degradation products have been quantified?
Stability testing as per SIM method and degradation
products has been quantified by the API manufacturer.
9. Do you have method for quantifying the
impurities in the API.
The firm has used HPLC method for chromatographic
impurities that was used for assay purpose.
10.
Do you have some remaining quantities of
the API, its reference standard and impurities
standards?
The firm has some quantities of API (As reference),
reference standard.
11. Have you used pharmaceutical grade
excipients?
The firm has used Pharmaceutical grade excipients
12. Do you have documents confirming the
import of the used excipients?
The firm has necessary documents confirming the
import of the used excipients.
13. Do you have test reports and other records on
the excipients used?
The firm has test reports and other records of the
excipient used.
14. Do you have written and authorized protocols
for the development of applied product?
The firm has written protocol for the development of
Sofosbuvir Tablets 400 mg.(Annex-D)
15.
Have you performed Drug-excipient
compatibility studies?
The firm has not performed drug excipient
compatibility studies because the composition of their
tablets/product is similar to that of the innovator’s
product (Sovaldi Tablets)
16.
Have you performed comparative dissolution
studies?
The firm has performed comparative dissolution studies
and their product show comparable dissolution profile
and same were reviewed at time of inspection.
17. Do you have product development (R&D)
section.
The firm has separate new product development (R&D)
section.
18.
Do you have necessary equipments available
in product development section for
development of applied product?
The firm has used Quality Control Lab instruments for
the development of Sofosbuvir Tablets 400 mg. The
firm has all necessary equipment in QC and Product
development section.
19. Are the equipment in product development
section qualified?
All the equipment used in the development of product
is qualified.
20.
Do you have proper maintenance / calibration
/ requalification program for the equipment
used in PD section?
The firm has proper maintenance and calibration for the
equipment used in quality Control for the development
of the product.
21.
Do you have qualified staff in product
development section with proper knowledge
and training in product development?
The firm has qualified staff for the development of the
product with proper knowledge and training in product
development. (Annex-E)
22.
Have you manufactured three stability
batches for the stability studies of applied
products required?
The firm has manufactured three stability batches, of
Sofosbuvir Tablets 400 mg, TR01, TR02, TR03.
23.
Do you have any criteria for fixing the batch
size of stability batches?
The criteria for fixing the batch size of stability of
batches are the number of tablets as per requirement of
testing.
24.
Do you have complete record of production
of stability batches?
The firm has complete record of production of stability
batches. All the log books are properly maintained and
reviewed at the time of inspection.
25. Do you have protocols for stability testing of
stability batches?
The firm has protocols for testing of the stability
batches.
26. Do you have developed and validated the
method for testing of stability batches?
Yes, the firm has used manufacturer’s method of
testing, the method is validated.
27.
Do you have method transfer studies in case
when the method of testing being used by
your firm is given by any other lab?
Not applicable
Minutes of 294th Meeting of Registration Board | 256
Conclusion:
M/s Zafa Pharmaceutical Laboratories was inspected as per directions contained in DRAP letter No. 13-11/2017-
PEC (Pt) dated 30th July, 2019. During inspection, the panel inspected/reviewed the relevant record, data and
premises in detail with specific focus on the observations/points made in above referred letter. Following are the
current observations:
1. Criterion/reference for selection of Q Value 70%: - The said molecules was not included in any
official monograph, therefore, the firm previously performed the dissolution test as per general requirement for
dissolution testing and there was no any specific criteria for the selection of Q value 70%. Now, the firm have
performed dissolution test for their product according to US-FDA recommended dissolution method and found
it satisfactory at the time of inspection.
2. Valid GMP Certificate of API Manufacturer is hereby attached for reference.
3. On the basis of risk-based approach the genuineness/ authenticity of stability data submitted by the firm
for registration of Sofosbuvir Tablets 400mg is verifiable to satisfactory level.
4. The related manufacturing area, equipment, personnel and utilities observed in line as per GMP
requirements and well suited for manufacturing of the said product.
Recommendations:
Based on the people met, documents reviewed and observations made during inspection including corrective
action taken by the firm, the panel unanimously recommends that the firm may kindly be granted necessary
registration of Sofosbuvir Tablets 400mg.
28.
Do you have documents confirming the
qualification of equipments / instruments
being used in the test and analysis of API and
the finished drug?
Yes, the firm has proper documents confirming the
qualification of equipment and instruments being used
in the test and analysis of API and the finished product.
29. Do your method of analysis stability
indicating?
Yes the method of analysis is stability indicating.
30. Do your HPLC software is 21CFR
compliant?
HPLC software is 21CFR compliant.
31. Can you show Audit Trail reports on Stability
study testing?
The firm showed the Audit trail report on API and
finished product testing.
32. Do you have some remaining quantities of
degradation products and stability batches?
The firm has remaining quantities of stability batches.
33. Do you have commitment batches kept on
stability testing?
The firm has three commitment batches kept on stability
testing for real time stability studies.
34.
Do you have valid calibration status for the
equipment used in Production and analysis?
Yes, the firm has valid calibration status for the
equipment used in the production and analysis of
Sofosbuvir Tablets 400 mg.
35. Do proper and continuous monitoring and
control are available for stability chambers.
Continuous power supply and monitoring and control
are available for the stability chambers.
36.
Do related manufacturing area, equipment,
personal and utilities be used as GMP
compliance
The relevant manufacturing facilities are GMP
complaint.
Decision: Registration Board decided to defer the case for following submissions:
Submit dissolution testing data with specifications of “NLT Q within 15 minutes” at initial and
one month time point at both accelerated and real time stability conditions for 2 batches.
Valid GMP certificate of the API manufacturer.
266. Name and address of manufacturer /
Applicant
M/s Biolabs, Kahuta Road, Islamabad.
Brand Name +Dosage Form + Strength Dexerid Capsule 30mg
Composition Each capsule contains:
Dexlansoprazole…30mg
Diary No. Date of R& I & fee Form-5 Dy.No 7194 (26-02-2018) Rs.20,000/- (26-02-2018)
Pharmacological Group PPI
Type of Form Form 5D
Minutes of 294th Meeting of Registration Board | 257
Finished product Specifications Manufacturer’s specifications
Pack size & Demanded Price As per SRO
Approval status of product in
Reference Regulatory Authorities
Approved in US-FDA
Me-too status (with strength and
dosage form)
Razodex Capsule by M/s Getz Pharma
STABILITY STUDY DATA
Drug Dexerid Capsule 30mg
Name of Manufacturer M/s Biolabs, Kahuta Road, Islamabad.
Manufacturer of API M/s Murli Krishna Pharma, D-98, MIDC., Rajangaon, ShirurTaluka, Pune Dist.
Maharashtra, India
API Lot No. Dexlansoperazole pellets 23.0% w/w. (Batch. # MKPPLR-DLF-18018)
Description of Pack
(Container closure system) Alu-Alu blister
Stability Storage Condition Real Time: 30oC ± 2oC / 65% ± 5%RH
Accelerated:40oC ±2oC / 75% ± 5%RH
Time Period Real Time: 06 Months Accelerated:06Months
Frequency Real Time: 0,3,6 Months(on going) Accelerated: 0,1,2,3,4,6 Months
Batch No. DEX-001 DEX-002 DEX-003
Batch Size 1500 Capsule Capsule Capsule
Manufacturing Date 08-2018 08-2018 08-2018
Date of Initiation - - -
No. of Batches 03
Date of Submission Dy No.3395, 12/04/2019
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr.# Documents To Be Provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country
of origin or GMP certificate of API manufacturer
issued by regulatory authority of country of origin.
The applicant has submitted the following
documents:
Copy Of GMP Certificate:
Certificate No: NEW-WHO-
GMP/CERT/PD/80503/2019/11/27529.
Issued to: M/s Murli Krishna Pharma.
D-98, MIDC.Rajangaon, ShirurTaluka, Pune Dist.
Maharashtra, India.
Issued on: 05-09-2018
Issued by: Food &Drug Administration,Bandra-
Kurla Complex, Maharastra, India.
Validity: 03-04-2022
3. Protocols followed for conduction of stability study
and details of tests.
Yes
4. Data of 03 batches will be supported by attested
respective documents like chromatograms,
laboratory reports, data sheets etc.
Yes
5. Documents confirming import of API etc. Applicant has submitted Copy Of Commercial
Invoice having following information on it:
Dexlansoperazole pellets 23.0% w/w
Minutes of 294th Meeting of Registration Board | 258
Quantity: 2000gm
Dexlansoperazole Working Standard
Quantity: 200mg
Signed by AD (I&E) Islamabad on 06-08-18.
6. All provided documents will be attested (name, sign
and stamp) for ensuring authenticity of data /
documents.
Yes
7. Commitment to continue real time stability study till
assigned shelf life of the product.
Yes
8. Commitment to follow Drug Specification Rules,
1978.
Yes
Evaluation by PEC:
267. Name and address of manufacturer
/ Applicant
M/s Biolabs, Kahuta Road, Islamabad.
Brand Name +Dosage Form + Strength Dexerid Capsule 60mg
Composition Each capsule contains:
Dexlansoprazole…60mg
Diary No. Date of R& I & fee Form-5 Dy.No 7195 (26-02-2018) Rs.20,000/- (26-02-2018)
Pharmacological Group PPI
Type of Form Form 5D
Finished product Specifications Manufacturer’s specifications
Pack size & Demanded Price As per SRO
Approval status of product in
Reference Regulatory Authorities
Approved in US-FDA
Me-too status (with strength and
dosage form)
Razodex Capsule by M/s Getz Pharma
STABILITY STUDY DATA
Drug Dexerid Capsule 60mg
Name of Manufacturer M/s Biolabs, Kahuta Road, Islamabad.
Manufacturer of API M/s Murli Krishna Pharma, D-98, MIDC., Rajangaon, ShirurTaluka, Pune Dist.
Maharashtra, India
API Lot No. Dexlansoperazole DDR pellets 17.0% w/w. (Batch. # DLT/SF/0010117)
Description of Pack
(Container closure system) Alu-Alu blister
Stability Storage Condition Real Time: 30oC ± 2oC / 65% ± 5%RH
Accelerated:40oC ±2oC / 75% ± 5%RH
Time Period Real Time: 09 Months
Accelerated:06Months
Frequency Real Time: 0,3,6 Months(on going)
Accelerated: 0,1,2,3,4,6 Months
Batch No. DEX-004 DEX-005 DEX-006
Batch Size 1500 Capsule 1500 Capsule 1500 Capsule
Manufacturing Date 08-2018 08-2018 08-2018
Date of Initiation - - -
No. of Batches 03
Date of Submission Dy No.3396, 12/04/2019
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Minutes of 294th Meeting of Registration Board | 259
Sr.# Documents To Be Provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country
of origin or GMP certificate of API manufacturer
issued by regulatory authority of country of origin.
The applicant has submitted the following
documents:
Copy Of GMP Certificate:
Certificate No: NEW-WHO-
GMP/CERT/PD/80503/2019/11/27529.
Issued to: M/s Murli Krishna Pharma.
D-98, MIDC. Rajangaon, ShirurTaluka, Pune Dist.
Maharashtra, India.
Issued on: 05-09-2018
Issued by: Food &Drug Administration,Bandra-
Kurla Complex, Maharastra, India.
Validity: 03-04-2022
3. Protocols followed for conduction of stability study
and details of tests.
Yes
4. Data of 03 batches will be supported by attested
respective documents like chromatograms,
laboratory reports, data sheets etc.
Yes
5. Documents confirming import of API etc. Applicant has submitted Copy Of Commercial
Invoice having following information on it:
Dexlansoperazole pellets 23.0% w/w
Quantity: 2000gm
Dexlansoperazole Working Standard
Quantity: 200mg
Signed by AD (I&E) Islamabad on 06-08-18.
6. All provided documents will be attested (name, sign
and stamp) for ensuring authenticity of data /
documents.
Yes
7. Commitment to continue real time stability study till
assigned shelf life of the product.
Yes
8. Commitment to follow Drug Specification Rules,
1978.
Yes
Evaluation by PEC:
Report on investigation of authenticity / genuineness of data submitted for registration of Dexerid
(Dexlansoprazole) 30mg & 60mg Capsule by M/s Bio-labs (Pvt) Ltd. Plot No. 145, Industrial Triangle
Kahuta Road, Islamabad.
Reference No: No. F.1-2/2020-PEC dated 18th February, 2020.
Investigation Date & Time: 11th March, 2020
Investigation Site: Factory premises of Bio-labs (Pvt) Ltd. Plot No. 145, Industrial Triangle Kahuta Road,
Islamabad.
Background: Chairman Registration Board has constituted the panel of M/s Bio-labs (Pvt) Ltd. Plot No. 145, Industrial Triangle
Kahuta Road, Islamabad for Dexerid (Dexlansoprazole) 30mg & 60mg Capsule for on-site investigation to
confirm the authenticity / genuineness of stability data and associated documents, import of API, quality,
specification, test analysis and facilities etc for further consideration by the Registration Board.
Composition of Panel:
1. Dr. Qurban Ali, Member Registration Board
2. Mst. Tehreem Sara, Deputy Director (RRR) PE&R Division DRAP, Islamabad
3. Mr. Muhammad Haseeb Tariq, Assistant Director PEC, PE&R Division DRAP, Islamabad.
Minutes of 294th Meeting of Registration Board | 260
Scope of Investigation:
Investigation of the authenticity / genuineness of the data, manufacturing of stability batches and stability studies
on these batches.
Tool for investigation:
The investigation was conducted by using a structured questionnaire of DRAP. For objective evidence physical
inspection of the facilities for manufacturing and quality control, material used and retained, personnel involved,
ongoing studies, printed data and integrity and security of data in respective databases were also audited. The
details of investigation is summarized as under:
Detail of investigation for Dexerid (Dexlansoprazole) 30mg & 60mg Capsule
Sr.
No.
Description Observation by panel
1. Do you have documents confirming the
import of API including approval from
DRAP?
Firm presented necessary documents including invoice
/AD clearance dated 06-08-2018 confirming import of
2 kg Dexlansoprazole pellets 23% w/w from M/s Murli
Krishna Pvt. Ltd. India. The date of invoice shown was
26-06-2018 since the firm received the pellets before
ADC clearance. After receiving the pellets, through
FedEx, the firm got AD clearance and then
manufactured three batches in August 2018.
2. Do you have any rationale behind selecting
the particular manufacturer
Firm has developed SOP for vendor qualification
including Vendor Evaluation Form and have selected
the subject vendor based on its GMP certificate, DMF
as well as stability study data.
3. Do you have documents confirming the
Import of Reference standard and Impurities
standards?
Working standard of Dexlansoprazole was provided by
the supplier. Working standard was supplied along with
API through the same invoice from M/s Murli Krishna
Pharma Pvt Ltd. India.
4. Do you have certificate of analysis of the API
reference standard and impurities standards?
Firm has certificate of analysis of API and of working
standard.
5. Do you have any approval of API or GMP
certificate of manufacturer issued by
regulatory authority of country of origin?
Firm has copy of GMP certificate from M/s Murli
Krishna Pharma Pvt Ltd. India issued by Food and
Drug Administration Mahrashtra State dated 05-9-
2018.
6. Do you use API manufacturer method of
Testing for testing of API?
The firm used API manufacturer method of testing for
carrying out tests of API.
7. Do you have stability Studies Report on API? The firm has real time and accelerated stability study
data sheets provided by the API manufacturer.
8. If Yes, whether the stability testing has been
performed as per SIM method and
degradation products have been quantified?
The stability studies have been performed as per SIM
method and the API manufacturer has quantified the
degradation products.
9. Do you have method for quantifying the
impurities in the API?
The firm has API manufacturer’s method for
quantifying the impurities in the API.
10. Do you have some remaining quantities of the
API, Its reference standard and impurities
standard?
The Firm was found having some remaining quantity
of API and working standards.
11. Have you used pharmaceutical grade
excipients?
This formulation only involves filling of pellets in
capsule shells.
12. Do you have documents confirming the
import of the used excipients?
Firm has locally purchased the hard gelatine capsule
shells.
Minutes of 294th Meeting of Registration Board | 261
13. Do you have test reports and other records on
the excipients?
The firm has test reports and certificate of analysis for
the hard gelatine capsule shell used in the
manufacturing of stability batches.
14. Do you have written and authorized protocols
for the development drug product?
The firm has written and authorized protocols for the
development of Dexerid (Dexlansoprazole) 30mg &
60mg Capsule.
15. Have you performed Drug-Excipient
compatibility studies?
Not applicable since this formulation only involves
filling of pellets in hard gelatine capsule shells.
16. Have you performed comparative dissolution
studies?
The Firm performed comparative dissolution studies
with the innovator product i.e. Dexilant capsule
manufactured by Takeda Pharma. The details of
comparative dissolution testing is as follows:
Detail Test product Reference product
Brand Dexerid 30mg
Capsule
Dexilant 30mg capsule
Batch# DEX-001 1538575
Detail Test product Reference product
Brand Dexerid 60mg
Capsule
Dexilant 60mg capsule
Batch# DEX-004 1538589
17. Do you have Product Development / R&D
Section?
Firm has dedicated area for product development.
18. Do you have necessary equipment’s available
in product development section for
development drug product?
Firm has necessary equipment available for product
development manufacture of trial batches.
19. Are the equipment’s in product development
qualified?
The equipment present in product development area
were qualified.
20. Do you have proper maintenance / calibration
/ re-qualification program for the equipment
used in PD?
The firm is preacticing maintenance and calibration for
the equipment used in product development section.
21. Do you have qualified staff in product
development section with proper knowledge
and training in product development?
Firm has trained & qualified staff in product
development section with relevant knowledge and
training in product development and testing.
22. Have you manufactured three stability
batches for the stability studies of drug
product?
Three stability batches have been manufactured for the
stability studies of Dexerid 30mg Capsule with batch
numbers DEX-001, DEX-002 and DEX-003 and
Dexerid 60mg Capsule with batch numbers DEX-004,
DEX-005 and DEX-006.
23. Do you have any criteria for fixing the batch
size of stability of batches?
The firm has informed that their criteria for fixing batch
size is based on number of tests required, testing
frequencies and number of units used in each test.
24. Do you have complete record of production of
stability batches?
The firm has complete batch manufacturing record of
all the batches of Dexerid 30mg Capsule and Dexerid
60mg Capsule.
25. Do you have protocols for stability testing of
stability batches?
Firm showed written protocols for stability testing of
the stability batches.
26. Do you have developed and validated the
method for testing of stability batches?
The firm has developed and validated method for
testing of the stability batches.
Minutes of 294th Meeting of Registration Board | 262
27. Do you have method transfer studies in case
when the method of testing being used by
your firm is by any other lab?
NA
28. Do you have documents confirming the
qualification of equipment / instruments
being used in the test and analysis of the
product’s API and drug product?
Firm has complete record of qualification of equipment
/ instruments used in the test and analysis of API and
Dexerid (Dexlansoprazole) 30mg & 60mg Capsule.
29. Do your method of analysis Stability
indicating?
The firm has quantified the degradation products after
12 months of stability testing.
30. Is your HPLC software 21CFR compliant? The firm has a dedicated HPLC (Schimadzu LC-20
Gradient) for testing of new drug products placed on
stability studies. The HPLC software for that particular
HPLC is 21 CFR compliant with audit trail option
activated. However the firm has only 1 login account in
the software which is used by various analysts on the
same system. The firm was advised to get separate
account for each analyst.
31. Can you show audit trail reports on drug
product testing?
Audit trail reports for testing of Dexerid
(Dexlansoprazole) 30mg & 60mg Capsule were
available.
32. Do you have some remaining quantities of
degradation products and stability batches?
The firm has remaining quantities of stability batches
which are kept in stability chamber for ongoing real
time stability study.
33. Do you have batches kept on stability testing? The firm has kept the remaining quantities of all
batches in stability chamber for on-going real time
stability study.
34. Do you have valid calibration status for the
equipment’s used in drug product’s
production and analysis?
The firm has valid calibration status of all equipment
used in production and analysis of Dexerid
(Dexlansoprazole) 30mg & 60mg Capsule.
35. Do Proper and Continuous monitoring and
control are available for stability chamber?
The firm has stability chambers for carrying out
accelerated and real time stability studies provided with
uninterrupted power supply and USB data loggers,
which are set for recording temperature and humidity
after every hour.
36. Do related manufacturing area, equipment,
personnel and utilities be rated as GMP
compliant?
Firm has dedicated area for product development.
Related manufacturing area, equipment, personnel and
utilities were cGMP compliant to satisfactory level.
37. Dissolution testing of pellets at pH 5.5 and pH
6.75/7 for confirmation of dual delayed
release formulation.
The firm found performed dissolution testing of pellets
at pH 5.5 and pH 6.75/7.0 to confirm the dual delayed
release formulation.
38. Date of initiation of stability studies for all the
three trial batches of applied formulation.
The date of initiation of all the batches of Dexerid
(Dexlansoprazole) 30mg & 60mg Capsule was
provided in the table below:
Product Batch No. Date of
initiation
Dexerid 30mg
Capsule
DEX-001 05-09-2018
DEX-002 05-09-2018
DEX-003 05-09-2018
Dexerid 60mg
Capsule
DEX-004 05-09-2018
DEX-005 05-09-2018
DEX-006 05-09-2018
Minutes of 294th Meeting of Registration Board | 263
Conclusion:
On the basis of risk-based approach the genuineness / authenticity of stability data submitted by the firm
for registration of Dexerid (Dexlansoprazole) 30mg & 60mg Capsule is verifiable to satisfactory level.
Related manufacturing area, equipment, personnel & utilities could be rated as GMP Compliant to
satisfactory level.
Decision: Registration Board decided to approve registration of Dexerid 30mg Capsule & Dexerid
60mg Capsule with Innovator’s specifications by M/s Bio-labs (Pvt) Ltd. Plot No. 145, Industrial
Triangle Kahuta Road, Islamabad. Manufacturer will place first three production batches on long
term stability studies throughout proposed shelf life and on accelerated studies for six months.
Item No. 9: Agenda of Evaluator PEC-IX Case no. 02 Registration applications of newly granted DML or New section (Human)
b. New/Additional section(s)
M/s Medizan Laboratories (Pvt.) Ltd. CLB in its 273rd meeting has granted the following New Section. The letter was issued on 18th February 2020.
The details of products applied for section is provided below:
It is pertinent to mention that the Licensing Division has issued the letter in the name of M/s Medizan
Pharmaceuticals inbstead of M/s Medizan Laboratories (Pvt.) Ltd. The firm has applied for the necessary
correction.
Section No. of molecules applied No. of products applied
Tablets Section Psychotropic 10 18
Tablet (Psychotropic) section: Molecules-10/ Products-18
268. Name and address of manufacturer
/Applicant
M/s Medizan Laboratories (Pvt) Ltd Plot no. 313, Industrial
Triangle Kahuta Road Islamabad, Pakistan.
Brand Name +Dosage Form + Strength ANXOL TABLETS 2mg
Composition Each tablet contains:
Diazepam…….2mg
Diary No. Date of R & I & fee Dy.No. 16013: 07-03-2019 Rs. 20,000/- Dated 07-03-2019
Pharmacological Group Benzodiazepine derivatives
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 30’s; as per SRO
Approval status of product in Reference
Regulatory Authorities.
Diazepam 2mg Tablets. MHRA approved
Me-too status Diazepam 2 mg Tablets. Reg. No. 79395
GMP Status New section
Remarks of the Evaluator ----
Decision: Approved.
269. Name and address of manufacturer
/Applicant
M/s Medizan Laboratories (Pvt) Ltd Plot no. 313, Industrial
Triangle Kahuta Road Islamabad, Pakistan.
Brand Name +Dosage Form + Strength ANXOL TABLETS 5mg
Composition Each tablet contains:
Diazepam…….5mg
Diary No. Date of R & I & fee Dy.No. 16012: 07-03-2019 Rs. 20,000/- Dated 07-03-2019
Pharmacological Group Benzodiazepine derivatives
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 30’s; as per SRO
Approval status of product in
Reference Regulatory Authorities.
Diazepam 5mg Tablets. MHRA approved
Me-too status VALIUM 5mg. Reg No. 003066
GMP status New section
Minutes of 294th Meeting of Registration Board | 264
Remarks of the Evaluator
Decision: Approved.
270. Name and address of manufacturer
/Applicant
M/s Medizan Laboratories (Pvt) Ltd Plot no. 313, Industrial
Triangle Kahuta Road Islamabad, Pakistan.
Brand Name +Dosage Form + Strength ANXOL TABLETS 10mg
Composition Each tablet contains:
Diazepam…….10mg
Diary No. Date of R & I & fee Dy.No. 16012: 07-03-2019 Rs. 20,000/- Dated 07-03-2019
Pharmacological Group Benzodiazepine derivatives
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 30’s; as per SRO
Approval status of product in Reference
Regulatory Authorities.
Diazepam 10mg Tablets. MHRA approved
Me-too status VALIUM 10mg. Reg No. 003480
GMP Status New section
Remarks of the Evaluator
Decision: Approved.
271. Name and address of manufacturer
/Applicant
M/s Medizan Laboratories (Pvt) Ltd Plot no. 313, Industrial
Triangle Kahuta Road Islamabad, Pakistan.
Brand Name +Dosage Form + Strength NIGHTUS TABLETS 0.25mg
Composition Each tablet contains:
Bromazepam…….0.25mg
Diary No. Date of R & I & fee Dy.No. 16014: 07-03-2019 Rs. 20,000/- Dated 07-03-2019
Pharmacological Group Benzodiazepine derivatives
Type of Form Form-5
Finished Product Specification The firm has innovator’s specifications
Pack size & Demanded Price 30’s, as per SRO
Approval status of product in
Reference Regulatory Authorities.
Could not be confirmed
Me-too status Could not be confirmed
GMP status New section
Remarks of the Evaluator
Decision: Deferred for the following:
Evidence of approval of applied formulation in reference regulatory authorities/agencies which
were adopted by the Registration Board in its 275th meeting.
Evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
alongwith registration number, brand name and name of firm.
272. Name and address of manufacturer
/Applicant
M/s Medizan Laboratories (Pvt) Ltd Plot no. 313, Industrial
Triangle Kahuta Road Islamabad, Pakistan.
Brand Name +Dosage Form + Strength NIGHTUS TABLETS 1.5mg
Composition Each tablet contains:
Bromazepam…….1.5mg
Diary No. Date of R & I & fee Dy.No. 16015: 07-03-2019 Rs. 20,000/- Dated 07-03-2019
Pharmacological Group Benzodiazepine derivatives
Type of Form Form-5
Finished Product Specification The firm has innovator’s specifications
Pack size & Demanded Price 30’s, as per SRO
Approval status of product in Reference
Regulatory Authorities.
BROMAZEPAM ARROW 1.5 mg tablet. ANSM approved
Me-too status Yazd 1.5mg Tablet. Reg No.071219
GMP Status New section
Remarks of the Evaluator
Decision: Approved.
Minutes of 294th Meeting of Registration Board | 265
273. Name and address of manufacturer
/Applicant
M/s Medizan Laboratories (Pvt) Ltd Plot no. 313, Industrial
Triangle Kahuta Road Islamabad, Pakistan.
Brand Name +Dosage Form + Strength NIGHTUS TABLETS 3mg
Composition Each tablet contains:
Bromazepam…….3mg
Diary No. Date of R & I & fee Dy.No. 16016: 07-03-2019 Rs. 20,000/- Dated 07-03-2019
Pharmacological Group Benzodiazepine derivatives
Type of Form Form-5
Finished Product Specification The firm has innovator’s specifications
Pack size & Demanded Price 30’s, Price as per SRO
Approval status of product in
Reference Regulatory Authorities.
Lexotan (3mg, 6mg) Tablets, uncoated. TGA Australia
Approved.
Me-too status Laxomac Tablet 3mg. Reg No. 83866
GMP status New section
Remarks of the Evaluator
Decision: Approved.
274. Name and address of manufacturer
/Applicant
M/s Medizan Laboratories (Pvt) Ltd Plot no. 313, Industrial
Triangle Kahuta Road Islamabad, Pakistan.
Brand Name +Dosage Form + Strength ALPAREX 0.25mg TABLETS
Composition Each Tablet Contains:
Alprazolam……..…. 0.25mg
Diary No. Date of R & I & fee Dy.No. 16017: 07-03-2019 Rs. 20,000/- Dated 07-03-2019
Pharmacological Group Benzodiazepine derivative
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 30’s, as per SRO
Approval status of product in Reference
Regulatory Authorities.
Xanax 250 microgram Tablets, uncoated. MHRA approved
Me-too status Medilap 0.25mg Tablet. Reg. NO. 80861
GMP Status New section
Remarks of the Evaluator
Decision: Approved.
275. Name and address of manufacturer
/Applicant
M/s Medizan Laboratories (Pvt) Ltd Plot no. 313, Industrial
Triangle Kahuta Road Islamabad, Pakistan.
Brand Name+Dosage Form + Strength ALPAREX 0.5mg TABLETS
Composition Each Tablet Contains:
Alprazolam……. 0.5mg
Diary No. Date of R & I & fee Dy.No. 16018: 07-03-2019 Rs. 20,000/- Dated 07-03-2019
Pharmacological Group Benzodiazepine derivative
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 30’s, as per SRO
Approval status of product in
Reference Regulatory Authorities.
Xanax 500 microgram Tablets, uncoated. MHRA approved
Me-too status Nirlam 0.5 mg Tablets. 79327
GMP status New section
Remarks of the Evaluator
Decision: Approved.
276. Name and address of manufacturer
/Applicant
M/s Medizan Laboratories (Pvt) Ltd Plot no. 313, Industrial
Triangle Kahuta Road Islamabad, Pakistan.
Brand Name +Dosage Form + Strength ALPAREX 1mg TABLETS
Composition Each Tablet Contains:
Alprazolam……. 1mg
Diary No. Date of R & I & fee Dy.No. 16019: 07-03-2019 Rs. 20,000/- dated 07-03-2019
Minutes of 294th Meeting of Registration Board | 266
Pharmacological Group Benzodiazepine derivative
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 30’s, as per SRO
Approval status of product in Reference
Regulatory Authorities.
Xanax (0.25mg, 0.5mg, 1mg, 2mg) uncoated Tablets.
USFDA approved
Me-too status Arnax Tablet 1mg. Reg. No. 78918
GMP Status New section
Remarks of the Evaluator
Decision: Approved.
277. Name and address of manufacturer
/Applicant
M/s Medizan Laboratories (Pvt) Ltd Plot no. 313, Industrial
Triangle Kahuta Road Islamabad, Pakistan.
Brand Name +Dosage Form + Strength CLEEP 0.5mg TABLETS
Composition Each tablet contains:
Clonazepam…………….0.5mg
Diary No. Date of R & I & fee Dy.No. 16020: 07-03-2019 Rs. 20,000/- dated 07-03-2019
Pharmacological Group Benzodiazepine derivative
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 30’s, Price as per SRO
Approval status of product in
Reference Regulatory Authorities.
Clonazepam Auden 500mcg Tablets. MHRA approved
Me-too status Clonazerain Tablet 0.5mg. Reg. No. 83865
GMP status New section
Remarks of the Evaluator
Decision: Approved.
278. Name and address of manufacturer
/Applicant
M/s Medizan Laboratories (Pvt) Ltd Plot no. 313, Industrial
Triangle Kahuta Road Islamabad, Pakistan.
Brand Name +Dosage Form + Strength CLEEP 2mg TABLETS
Composition Each tablet contains:
Clonazepam…………….2mg
Diary No. Date of R & I & fee Dy.No. 16277: 07-03-2019 Rs. 20,000/- dated 07-03-2019
Pharmacological Group Benzodiazepine derivative
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 30’s, as per SRO
Approval status of product in Reference
Regulatory Authorities.
Clonazepam Auden 500mcg Tablets. MHRA approved
Me-too status Clonazep 2 mg Tablets. Reg. No. 78589
GMP Status New section
Remarks of the Evaluator
Decision: Approved.
279. Name and address of manufacturer
/Applicant
M/s Medizan Laboratories (Pvt) Ltd Plot no. 313, Industrial
Triangle Kahuta Road Islamabad, Pakistan.
Brand Name +Dosage Form + Strength FENOBARB 30mg TABLETS
Composition Each tablet contains:
Phenobarbital……… 30mg
Diary No. Date of R & I & fee Dy.No. 16278: 07-03-2019 Rs. 20,000/- dated 07-03-2019
Pharmacological Group Barbiturates and derivatives
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 100’s, Price as per SRO
Approval status of product in
Reference Regulatory Authorities.
Phenobarbital Tablets 30mg. MHRA approved
Minutes of 294th Meeting of Registration Board | 267
Me-too status Fenotal 30 mg Tablets. Reg. No. 79323
GMP status New section
Remarks of the Evaluator
Decision: Approved.
280. Name and address of manufacturer
/Applicant
M/s Medizan Laboratories (Pvt) Ltd Plot no. 313, Industrial
Triangle Kahuta Road Islamabad, Pakistan.
Brand Name +Dosage Form + Strength LOPEZ 1mg TABLETS
Composition Each tablet contains:-
Lorazepam…….…….1mg
Diary No. Date of R & I & fee Dy.No. 16279: 07-03-2019 Rs. 20,000/- dated 07-03-2019
Pharmacological Group Benzodiazepine derivative
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 100’s, as per SRO
Approval status of product in Reference
Regulatory Authorities.
LORAZIUM/Lorazepam Tablets (0.5mg, 1mg, 2.5mg),
uncoated. MHRA approved
Me-too status Lorazepam 1 mg Tablets. Reg. No. 79396
GMP Status New section
Remarks of the Evaluator
Decision: Approved.
281. Name and address of manufacturer
/Applicant
M/s Medizan Laboratories (Pvt) Ltd Plot no. 313, Industrial
Triangle Kahuta Road Islamabad, Pakistan.
Brand Name +Dosage Form + Strength LOPEZ 2mg TABLETS
Composition Each tablet contains:-
Lorazepam…….…….2mg
Diary No. Date of R & I & fee Dy.No. 16280: 07-03-2019 Rs. 20,000/- dated 07-03-2019
Pharmacological Group Benzodiazepine derivative
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 100’s, as per SRO
Approval status of product in
Reference Regulatory Authorities.
Ativan® C-IV (lorazepam) (0.5mg, 1mg, 2mg) Tablets,
uncoated. USFDA approved
Me-too status Lorazepam 2 mg Tablets. Reg. No. 79397
GMP status New section
Remarks of the Evaluator
Decision: Approved.
282. Name and address of manufacturer
/Applicant
M/s Medizan Laboratories (Pvt) Ltd Plot no. 313, Industrial
Triangle Kahuta Road Islamabad, Pakistan.
Brand Name +Dosage Form + Strength ZLEEP 10mg TABLETS
Composition Each Film Coated Tablet Contains:
Zolpidem Tartrate…….10mg
Diary No. Date of R & I & fee Dy.No. 16283: 07-03-2019 Rs. 20,000/- dated 07-03-2019
Pharmacological Group Benzodiazepine related drugs
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 100’s, as per SRO
Approval status of product in Reference
Regulatory Authorities.
Zolpidem Tartrate (5mg, 10 mg) Tablets, film-coated.
MHRA Approved.
Me-too status Ensomie Tablet 10mg, film-caoted. Reg. No. 85026
GMP Status New section
Remarks of the Evaluator
Decision: Approved.
Minutes of 294th Meeting of Registration Board | 268
283. Name and address of manufacturer
/Applicant
M/s Medizan Laboratories (Pvt) Ltd Plot no. 313, Industrial
Triangle Kahuta Road Islamabad, Pakistan.
Brand Name +Dosage Form + Strength PARACORD TABLETS
Composition Each tablet contains:-
Paracetamol…..500mg
Codeine phosphate hemihydrate…..15mg
Diary No. Date of R & I & fee Dy.No. 16281: 07-03-2019 Rs. 20,000/- dated 07-03-2019
Pharmacological Group Analgesics
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 30’s, Price as per SRO
Approval status of product in
Reference Regulatory Authorities.
Co-codamol (8mg/500 mg, 15mg/500 mg, 30mg/500 mg)
Tablets. MHRA Approved
Me-too status CODOGESIC 15mg/500 mg tablet. Reg. No.: 028956
GMP status New section
Remarks of the Evaluator The reference product contains Codeine phosphate
hemihydrate ….15mg without equivalency.
Correction is required.
Decision: Deferred for revision of label claim as per reference product along with submission of
requisite fee.
284. Name and address of manufacturer
/Applicant
M/s Medizan Laboratories (Pvt) Ltd Plot no. 313, Industrial
Triangle Kahuta Road Islamabad, Pakistan.
Brand Name +Dosage Form + Strength RITAZAN 10mg TABLETS
Composition Each tablet contains:-
Methylphenidate hydrochloride ……...10mg
Diary No. Date of R & I & fee Dy.No. 16284: 07-03-2019 Rs. 20,000/- dated 07-03-2019
Pharmacological Group Centrally acting sympathomimetics
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 30’s, as per SRO
Approval status of product in Reference
Regulatory Authorities.
Ritalin Tablet (5mg, 10mg, 20mg). USFDA approved
Me-too status Phenida Tablets 10mg. Reg. No. 34745
GMP Status New section
Remarks of the Evaluator
Decision: Approved.
285. Name and address of manufacturer
/Applicant
M/s Medizan Laboratories (Pvt) Ltd Plot no. 313, Industrial
Triangle Kahuta Road Islamabad, Pakistan.
Brand Name +Dosage Form + Strength RALIF MAX TABLETS
Composition Each Tablet Contains:
Ibuprofen ……..………..…200mg
Pseudoephidrine HCl ……..…….30mg
Diary No. Date of R & I & fee Dy.No. 16282: 07-03-2019 Rs. 20,000/- dated 07-03-2019
Pharmacological Group Analgesic
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 100’s, Price as per SRO
Approval status of product in
Reference Regulatory Authorities.
Boots Cold & Flu Relief with Ibuprofen film coated tablet
200mg/30mg. MHRA approved
Me-too status Rovinac Tablets. Reg No. 64206
GMP status New section
Remarks of the Evaluator
Decision: Deferred for consideration of the application on its turn, since the applied formulation is
not psychotropic.
Minutes of 294th Meeting of Registration Board | 269
Case no. 04 Registration applications of newly granted DML or New section (Veterinary)
a. New DML /section The CLB in its 271st meeting granted new DML to the firm. The letter was issued on 26.09.2019. The firm
has applied for the products mentioned against each section
Section Number of molecules Number of products
Oral Powders 10 11
Oral Liquids 10 10
Oral Powder Section
286. Name and address of manufacturer /
Applicant
Fizi Pharmaceutical & Chemical Laboratories,
8-Km Sikka Street Bhubatian, Raiwind Road Lahore
Brand Name +Dosage Form + Strength Amandin Water Soluble Powder
Composition Each 1000g Powder Contains
Amantadine HCl …….100g
Diary No. Date of R& I & fee Dy. No. 27676: 19-12-2019 PKR 20,000/-: 19-12-2019
Pharmacological Group Adamantane derivatives
Type of Form Form-5
Finished Product Specification Innovator’s specification
Pack size & Demanded Price 100 g, 250 g, 500 g, 1000 g, 2500 g 5000 g 10000 g and
25000 g ; Decontrolled
Me-too status VIZON WATER SOLUBLE POWDER. Reg. No. 96788
GP status New DML
Remarks of the Evaluator.
Decision: Approved with pack size upto 10000g (10kg).
287. Name and address of manufacturer /
Applicant
Fizi Pharmaceutical & Chemical Laboratories,
8-Km Sikka Street Bhubatian, Raiwind Road Lahore
Brand Name +Dosage Form + Strength Doxybect-50 Water Soluble Powder
Composition Each 1000g powder Contains
Doxycycline HCl ……………...500g
Diary No. Date of R& I & fee Dy.No. 27674: 19.12.2019 PKR 20,000/-: 19.12.2019
Pharmacological Group Tetracyclines
Type of Form Form-5
Finished Product Specification Innovator’s specification
Pack size & Demanded Price 100 g, 250 g, 500 g, 1000 g, 2500 g 5000 g 10000 g and
25000 g ; Decontrolled
Me-too status Doxy-Mix 50 Powder. Reg. No. 059166
GP status New DML
Remarks of the Evaluator.
Decision: Approved with pack size upto 10000g (10kg).
288. Name and address of manufacturer /
Applicant
Fizi Pharmaceutical & Chemical Laboratories,
8-Km Sikka Street Bhubatian, Raiwind Road Lahore
Brand Name +Dosage Form + Strength Floxycol Water Soluble Powder
Composition Each g Contains:
Florfenicol…….150 mg
Oxytetracycline HCl…..150 mg
Diary No. Date of R& I & fee Dy.No. 27671: 19.12.2019 PKR 20,000/-: 19.12.2019
Pharmacological Group Antibiotics
Type of Form Form-5
Finished Product Specification Innovator’s specification
Pack size & Demanded Price 100 g, 250 g, 500 g, 1000 g, 2500 g 5000 g 10000 g &
25000g ; Decontrolled
Me-too status Floxybar-30 Water Soluble Powder. Reg. No. 072601
GP status New DML
Remarks of the Evaluator.
Decision: Approved with pack size upto 10000g (10kg).
Minutes of 294th Meeting of Registration Board | 270
289. Name and address of manufacturer /
Applicant
Fizi Pharmaceutical & Chemical Laboratories,
8-Km Sikka Street Bhubatian, Raiwind Road Lahore
Brand Name +Dosage Form + Strength Floxynor Oral Powder
Composition Each g Contain
Neomycin Sulphate…..150 mg.
Florfenicol…….100 mg
Oxytetracycline HCl…..300 mg
Diary No. Date of R& I & fee Dy.No. 27670: 19.12.2019 PKR 20,000/-: 19.12.2019
Pharmacological Group Antibiotics
Type of Form Form-5
Finished Product Specification Innovator’s specification
Pack size & Demanded Price 100 g, 250 g, 500 g, 1000 g, 2500 g 5000 g 10000 g and
25000 g ; Decontrolled
Me-too status Neoxflor Oral Powder. Reg. No. 088638
GP status New DML
Remarks of the Evaluator.
Decision: Approved with pack size upto 10000g (10kg).
290. Name and address of manufacturer /
Applicant
Fizi Pharmaceutical & Chemical Laboratories,
8-Km Sikka Street Bhubatian, Raiwind Road Lahore
Brand Name +Dosage Form + Strength Furamin Water Soluble Powder
Composition Each 1000g Contains
Furosemide…….20g
Potassium chloride……..4g
Calcium carbonate…..45g
Magnesium sulphate…….1g
Diary No. Date of R& I & fee Dy.No. 27679: 19.12.2019 PKR 20,000/-: 19.12.2019
Pharmacological Group Diuretic and electrolytes
Type of Form Form-5
Finished Product Specification Innovator’s specification
Pack size & Demanded Price 100 g, 250 g, 500 g, 1000 g, 2500 g 5000 g 10000 g and
25000 g ; Decontrolled
Me-too status Furosebar Water Soluble Powder. Reg. No. 075783
GP status New DML
Remarks of the Evaluator.
Decision: Approved with pack size upto 10000g (10kg).
291. Name and address of manufacturer /
Applicant
Fizi Pharmaceutical & Chemical Laboratories,
8-Km Sikka Street Bhubatian, Raiwind Road Lahore
Brand Name +Dosage Form + Strength Colinco Water Soluble Powder
Composition Each g Contains
Lincomycin HCl ……….100 mg.
Colistin Sulphate ….800,000 I.U.
Diary No. Date of R& I & fee Dy.No. 27673: 19.12.2019 PKR 20,000/-: 19.12.2019
Pharmacological Group ( Antibiotic/Antibacterial )
Type of Form Form-5
Finished Product Specification Innovator’s specification
Pack size & Demanded Price 100 g, 250 g, 500 g, 1000 g, 2500 g 5000 g 10000 g and
25000 g ; Decontrolled
Me-too status Nobi-Lincol Powder. Reg. No. 079116
GP status New DML
Remarks of the Evaluator.
Decision: Approved with pack size upto 10000g (10kg).
292. Name and address of manufacturer /
Applicant
Fizi Pharmaceutical & Chemical Laboratories,
8-Km Sikka Street Bhubatian, Raiwind Road Lahore
Brand Name +Dosage Form + Strength Multimeth WSP
Minutes of 294th Meeting of Registration Board | 271
Composition Each 100 g Powder contains;
Methenamine........... 95g
Vitamin B1............0.80g
Vitamin B2............0.92g
Vitamin K3............0.2g
Diary No. Date of R& I & fee Dy.No. 27678: 19.12.2019 PKR 20,000/-: 19.12.2019
Pharmacological Group Multivitamins and antibiotics
Type of Form Form-5
Finished Product Specification Innovator’s specification
Pack size & Demanded Price 100 g, 250 g, 500 g, 1000 g, 2500 g 5000 g 10000 g and
25000 g ; Decontrolled
Me-too status Diuriq WSP. Reg. No. 080735
GP status New DML
Remarks of the Evaluator.
Decision: Approved with pack size upto 10000g (10kg).
293. Name and address of manufacturer /
Applicant
Fizi Pharmaceutical & Chemical Laboratories,
8-Km Sikka Street Bhubatian, Raiwind Road Lahore
Brand Name +Dosage Form + Strength NEOXYCOL POWDER
Composition Each 1000 g Contains:
Neomycin sulphate ...........250g.
Colistin sulphate........... 300 M.I.U.
Oxytetracycline HCl...........250g.
Diary No. Date of R& I & fee Dy.No. 27677: 19.12.2019 PKR 20,000/-: 19.12.2019
Pharmacological Group Antibiotics
Type of Form Form-5
Finished Product Specification Innovator’s specification
Pack size & Demanded Price 100 g, 250 g, 500 g, 1000 g, 2500 g 5000 g 10000 g and
25000 g ; Decontrolled
Me-too status ONC Forte Powder. Reg. No. 078217
GP status New DML
Remarks of the Evaluator.
Decision: Approved with pack size upto 10000g (10kg).
294. Name and address of manufacturer /
Applicant
Fizi Pharmaceutical & Chemical Laboratories,
8-Km Sikka Street Bhubatian, Raiwind Road Lahore
Brand Name +Dosage Form + Strength Sulphazine Oral Powder
Composition Each 100g Powder Contains
Sulfachlorpyridazine ….….30g
Diary No. Date of R& I & fee Dy.No : 19.12.2019 PKR 20,000/-: 19.12.2019
Pharmacological Group Antibiotics
Type of Form Form-5
Finished Product Specification Innovator’s specification
Pack size & Demanded Price 100 g, 250 g, 500 g, 1000 g, 2500 g 5000 g 10000 g and
25000 g ; Decontrolled
Me-too status Coxiriq Oral Powder. Reg. No. 079814
GP status New DML
Remarks of the Evaluator.
Decision: Approved with pack size upto 10000g (10kg).
295. Name and address of manufacturer /
Applicant
Fizi Pharmaceutical & Chemical Laboratories,
8-Km Sikka Street Bhubatian, Raiwind Road Lahore
Brand Name +Dosage Form + Strength Tycobrox Water Soluble Powder
Composition Each 1000 g Contains
Tylosin Tartrate..........100 g
Doxycycline HCl...........200 g
Colistin sulphate...........500M.I.U.
Minutes of 294th Meeting of Registration Board | 272
Bromhexine HCl ...........5g
Diary No. Date of R& I & fee Dy.No. 27672: 19.12.2019 PKR 20,000/-: 19.12.2019
Pharmacological Group Antibiotic and expectorant
Type of Form Form-5
Finished Product Specification Innovator’s specification
Pack size & Demanded Price 100 g, 250 g, 500 g, 1000 g, 2500 g 5000 g 10000 g and
25000 g ; Decontrolled
Me-too status Tycobar-D Water Soluble Powder. Reg. No. 071099
GP status New DML
Remarks of the Evaluator.
Decision: Approved with pack size upto 10000g (10kg).
296. Name and address of manufacturer /
Applicant
Fizi Pharmaceutical & Chemical Laboratories,
8-Km Sikka Street Bhubatian, Raiwind Road Lahore
Brand Name +Dosage Form + Strength Tycodox Water Soluble Powder
Composition Each 1000 g Contains
Tylosin Tartrate...........100 g
Doxycycline HCl........... 200 g
Colistin sulphate...........450M.I.U.
Bromhexine HCl...........4g
Diary No. Date of R& I & fee Dy.No. 27675: 19.12.2019 PKR 20,000/-: 19.12.2019
Pharmacological Group Antibiotic and expectorant
Type of Form Form-5
Finished Product Specification Innovator’s specification
Pack size & Demanded Price 100 g, 250 g, 500 g, 1000 g, 2500 g 5000 g 10000 g and
25000 g ; Decontrolled
Me-too status Doxyline Water Soluble Powder. Reg. No. 075776
GP status New DML
Remarks of the Evaluator.
Decision: Approved with pack size upto 10000g (10kg).
Oral Liquid Section
297. Name and address of manufacturer /
Applicant
Fizi Pharmaceutical & Chemical Laboratories,
8-Km Sikka Street Bhubatian, Raiwind Road Lahore
Brand Name +Dosage Form + Strength Bromfiz Oral Liquid
Composition Each ml contains:
Bromhexine HCl……50 mg
Diary No. Date of R& I & fee Dy.No. 27664: 19.12.2019 PKR 20,000/-: 19.12.2019
Pharmacological Group Expectorants
Type of Form Form-5
Finished Product Specification Innovator’s specification
Pack size & Demanded Price 100 ml, 250 ml, 450 ml, 500, ml, 1000 ml and 5000 ml;
Decontrolled
Me-too status Brombar-5 Oral Liquid. Reg. No. 073947
GP status New DML
Remarks of the Evaluator.
Decision: Approved.
298. Name and address of manufacturer /
Applicant
Fizi Pharmaceutical & Chemical Laboratories,
8-Km Sikka Street Bhubatian, Raiwind Road Lahore
Brand Name +Dosage Form + Strength Bromfiz Plus Oral Liquid
Composition Each ml contains:
Menthol …………..40 mg
Bromhexine HCl….20 mg
Diary No. Date of R& I & fee Dy.No. 27663: 19.12.2019 PKR 20,000/-: 19.12.2019
Pharmacological Group Expectorants
Type of Form Form-5
Minutes of 294th Meeting of Registration Board | 273
Finished Product Specification Innovator’s specification
Pack size & Demanded Price 100 ml, 250 ml, 450 ml, 500, ml, 1000 ml and 5000 ml;
Decontrolled
Me-too status BROMO PLUS LIQUID. Reg. No. 073917
GP status New DML
Remarks of the Evaluator.
Decision: Approved.
299. Name and address of manufacturer /
Applicant
Fizi Pharmaceutical & Chemical Laboratories,
8-Km Sikka Street Bhubatian, Raiwind Road Lahore
Brand Name +Dosage Form + Strength Enrobrostin Oral Solution
Composition Each 100ml contains:
Enrofloxacin………. 10.0g
Colistin Sulphate …..50MIU
Bromhexine HCl….…5.0g
Diary No. Date of R& I & fee Dy.No. 27667: 19.12.2019 PKR 20,000/-: 19.12.2019
Pharmacological Group Antibiotics and expectorant
Type of Form Form-5
Finished Product Specification Innovator’s specification
Pack size & Demanded Price 100 ml, 250 ml, 450 ml, 500, ml, 1000 ml and 5000 ml;
Decontrolled
Me-too status Inter Flox liquid. Reg. No. 078241
GP status New DML
Remarks of the Evaluator.
Decision: Approved.
300. Name and address of manufacturer /
Applicant
Fizi Pharmaceutical & Chemical Laboratories,
8-Km Sikka Street Bhubatian, Raiwind Road Lahore
Brand Name +Dosage Form + Strength Enrophen Oral Liquid
Composition Each 100ml contains
Enrofloxacin……… 10.0g
Aminophylline…. …..4.0g
Guaiphenesin………10.0g
Diary No. Date of R& I & fee Dy.No. 27661: 19.12.2019 PKR 20,000/-: 19.12.2019
Pharmacological Group Antibiotics, bronchodilator and expectorant
Type of Form Form-5
Finished Product Specification Innovator’s specification
Pack size & Demanded Price 100 ml, 250 ml, 450 ml, 500, ml, 1000 ml and 5000 ml;
Decontrolled
Me-too status Enrophylin Oral Liquid. Reg. No. 080730
GP status New DML
Remarks of the Evaluator.
Decision: Approved.
301. Name and address of manufacturer /
Applicant
Fizi Pharmaceutical & Chemical Laboratories,
8-Km Sikka Street Bhubatian, Raiwind Road Lahore
Brand Name +Dosage Form + Strength Floricol Oral Solution
Composition Each 1000 ml contains:
Florfenicol...........200g
Diary No. Date of R& I & fee Dy.No. 27665: 19.12.2019 PKR 20,000/-: 19.12.2019
Pharmacological Group Antibiotics
Type of Form Form-5
Finished Product Specification Innovator’s specification
Pack size & Demanded Price 100 ml, 250 ml, 450 ml, 500, ml, 1000 ml and 5000 ml;
Decontrolled
Me-too status FLUROTIN Liquid. Reg. No. 075751
Minutes of 294th Meeting of Registration Board | 274
GP status New DML
Remarks of the Evaluator.
Decision: Approved.
302. Name and address of manufacturer /
Applicant
Fizi Pharmaceutical & Chemical Laboratories,
8-Km Sikka Street Bhubatian, Raiwind Road Lahore
Brand Name +Dosage Form + Strength Floricol Plus Oral Solution
Composition Each 100ml contains:
Florfenicol ...........23g
Colistin sulphate........... 50MIU
Diary No. Date of R& I & fee Dy.No. 27668: 19.12.2019 PKR 20,000/-: 19.12.2019
Pharmacological Group Antibiotics
Type of Form Form-5
Finished Product Specification Innovator’s specification
Pack size & Demanded Price 100 ml, 250 ml, 450 ml, 500, ml, 1000 ml and 5000 ml;
Decontrolled
Me-too status Fenicol-23 oral solution. Reg. No. 080731
GP status New DML
Remarks of the Evaluator.
Decision: Approved.
303. Name and address of manufacturer /
Applicant
Fizi Pharmaceutical & Chemical Laboratories,
8-Km Sikka Street Bhubatian, Raiwind Road Lahore
Brand Name +Dosage Form + Strength Floxacin Oral Liquid
Composition Each 1000 ml contains:
Enrofloxacin……100g
Diary No. Date of R& I & fee Dy.No.27660: 19.12.2019 PKR 20,000/-: 19.12.2019
Pharmacological Group Antibiotics
Type of Form Form-5
Finished Product Specification Innovator’s specification
Pack size & Demanded Price 100 ml, 250 ml, 450 ml, 500, ml, 1000 ml and 5000 ml;
Decontrolled
Me-too status Enroriq-10 Oral Liquid. Reg. No. 079813
GP status New DML
Remarks of the Evaluator.
Decision: Approved.
304. Name and address of manufacturer /
Applicant
Fizi Pharmaceutical & Chemical Laboratories,
8-Km Sikka Street Bhubatian, Raiwind Road Lahore
Brand Name +Dosage Form + Strength Hepafiz Oral Liquid
Composition Each ml contains:
L-Carnitine....................50mg
Betaine..........................20mg
Inositol .........................7mg
Choline cholride...........100mg
Sorbitol...............................200mg
Magnesium sulphate...........10mg
Diary No. Date of R& I & fee Dy.No. 27662: 19.12.2019 PKR 20,000/-: 19.12.2019
Pharmacological Group Liver therapy
Type of Form Form-5
Finished Product Specification Innovator’s specification
Pack size & Demanded Price 100 ml, 250 ml, 450 ml, 500, ml, 1000 ml and 5000 ml;
Decontrolled
Me-too status Hepabar Oral Liquid. Reg. No. 080733
GP status New DML
Remarks of the Evaluator.
Decision: Approved.
Minutes of 294th Meeting of Registration Board | 275
305. Name and address of manufacturer /
Applicant
Fizi Pharmaceutical & Chemical Laboratories,
8-Km Sikka Street Bhubatian, Raiwind Road Lahore
Brand Name +Dosage Form + Strength Micosil Oral Liquid
Composition Each ml contains:
Tilmicosin Phosphate ……..250mg
Diary No. Date of R& I & fee Dy.No. 27659: 19.12.2019 PKR 20,000/-: 19.12.2019
Pharmacological Group Antibiotics
Type of Form Form-5
Finished Product Specification Innovator’s specification
Pack size & Demanded Price 100 ml, 250 ml, 450 ml, 500, ml, 1000 ml and 5000 ml;
Decontrolled
Me-too status Tilmofas oral liquid. Reg. No. 046644
GP status New DML
Remarks of the Evaluator.
Decision: Approved.
306. Name and address of manufacturer /
Applicant
Fizi Pharmaceutical & Chemical Laboratories,
8-Km Sikka Street Bhubatian, Raiwind Road Lahore
Brand Name +Dosage Form + Strength Sulphatrim-T Oral Solution
Composition Each ml contains:
Tylosin tartrate….55mg
Sulphadiazine ….175mg
Trimethoprim …..35mg
Diary No. Date of R& I & fee Dy.No. 27666: 19.12.2019 PKR 20,000/-: 19.12.2019
Pharmacological Group Antibiotics
Type of Form Form-5
Finished Product Specification Innovator’s specification
Pack size & Demanded Price 100 ml, 250 ml, 450 ml, 500, ml, 1000 ml and 5000 ml;
Decontrolled
Me-too status Respibar-250 Oral Solution. Reg No. 071095
GP status New DML
Remarks of the Evaluator.
Decision: Approved.
CLB in its 271st meeting held on 12th September 2019 has considered and approved the grant of the
following additional section.
Liquid Injection Section Vials (Penicillin Veterinary) (10 molecules/19 products)
307. Name and address of manufacturer /
Applicant
Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National
Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Moxillin LA Injection
Composition Each ml contains:
Amoxicillin as Trihydrate……...150 mg
Diary No. Date of R&I & Fee Dy. No. 21188: 18-10-2019, Rs. 20,000/-: 18-10.2019
Pharmacological Group Antibiotic
Type of Form Form-5
Finished product Specification BP
Pack size & Demanded Price 50ml; Decontrolled
Me-too status V-MOX L.A 15% INJECTION (50ml). Reg. 084965
GMP status New Section Veterinary Liquid Injection Penicillin
Remarks of the Evaluator
Decision: Approved.
308. Name and address of manufacturer /
Applicant
Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National
Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Moxillin LA Injection
Composition Each ml contains:
Amoxicillin Trihydrate……...150 mg
Minutes of 294th Meeting of Registration Board | 276
Diary No. Date of R&I & Fee Dy. No. 21187: 18-10-2019, Rs. 20,000/-: 18-10.2019
Pharmacological Group Antibiotic
Type of Form Form-5
Finished product Specification BP
Pack size & Demanded Price 100ml; Decontrolled
Me-too status Amoxibar LA Injection (100ml). Reg. 087147
GMP status New Section Veterinary Liquid Injection Penicillin
Remarks of the Evaluator
Decision: Approved.
309. Name and address of manufacturer /
Applicant
Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National
Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Moxillin Plus LA Injection
Composition Each ml contains:
Amoxicillin as Trihydrate……...200 mg
Diary No. Date of R&I & Fee Dy. No. 21191: 18-10-2019, Rs. 20,000/-: 18-10.2019
Pharmacological Group Antibiotic
Type of Form Form-5
Finished product Specification BP
Pack size & Demanded Price 50ml; Decontrolled
Me-too status Zamox LA 20% Injection (10ml, 30ml, 50ml, 100ml).
Ristration No. 048154
GMP status New Section Veterinary Liquid Injection Penicillin
Remarks of the Evaluator
Decision: Approved.
310. Name and address of manufacturer /
Applicant
Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National
Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Moxillin Plus LA Injection
Composition Each ml contains:
Amoxicillin as Trihydrate……...200 mg
Diary No. Date of R&I & Fee Dy. No. 21189: 18-10-2019, Rs. 20,000/-: 18-10.2019
Pharmacological Group Antibiotic
Type of Form Form-5
Finished product Specification BP
Pack size & Demanded Price 100ml; Decontrolled
Me-too status Zamox LA 20% Injection
(10ml/30ml/50ml/100ml).R.#048154
GMP status New Section Veterinary Liquid Injection Penicillin
Remarks of the Evaluator
Decision: Approved.
311. Name and address of manufacturer /
Applicant
Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National
Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Mox-C Injection
Composition Each ml contains:
Amoxicillin as Trihydrate.……..…...100 mg
Colistin Sulphate…………………...250,000 IU
Diary No. Date of R&I & Fee Dy. No. 21190: 18-10-2019, Rs. 20,000/-, 18-10-2019
Pharmacological Group Antibiotic
Type of Form Form-5
Finished product Specification Manufacturer's specification
Pack size & Demanded Price 50ml; Decontrolled
Me-too status Colimoxbar Injection (100ml). No. 087151
Minutes of 294th Meeting of Registration Board | 277
AMCOCIN INJECTION (50ml). Reg. NO. 82797
(amoxicillin as Trihydrate).
GMP status New Section Veterinary Liquid Injection Penicillin
Remarks of the Evaluator
Decision: Approved with innovator’s specifications.
312. Name and address of manufacturer /
Applicant
Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National
Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Mox-C Injection
Composition Each ml contains:
Amoxicillin as Trihydrate..……..…...100 mg
Colistin Sulphate……...…………...250,000 IU
Diary No. Date of R&I & Fee Dy. No. 21191: 18-10-2019, Rs. 20,000/-, 18-10-2019
Pharmacological Group Antibiotic
Type of Form Form-5
Finished product Specification Manufacturer's specification
Pack size & Demanded Price 100ml; Decontrolled
Me-too status Colimoxbar Injection (100ml). Reg. 087151
GMP status New Section Veterinary Liquid Injection Penicillin
Remarks of the Evaluator
Decision: Approved with innovator’s specifications.
313. Name and address of manufacturer /
Applicant
Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National
Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Mox-C Plus LA Injection
Composition Each ml contains:
Amoxicillin as Trihydrate……..…...120 mg
Colistin Sulphate……………….…300,000 IU
Diary No. Date of R&I & Fee Dy. No. 21192: 18-10-2019, Rs. 20,000/-, 18-10-2019
Pharmacological Group Antibiotic
Type of Form Form-5
Finished product Specification Manufacturer's specification
Pack size & Demanded Price 50ml; Decontrolled
Me-too status COLICILLIN L.A INJECTION (50ml). Reg. No. 87153
GMP status New Section Veterinary Liquid Injection Penicillin
Remarks of the Evaluator
Decision: Approved with innovator’s specifications.
314. Name and address of manufacturer /
Applicant
Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National
Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Mox-C Plus LA Injection
Composition Each ml contains:
Amoxicillin as Trihydrate……..…...120 mg
Colistin Sulphate…………….……300,000 IU
Diary No. Date of R&I & Fee Dy. No. 21193: 18-10-2019, Rs. 20,000/-: 18-10.2019
Pharmacological Group Antibiotic
Type of Form Form-5
Finished product Specification Manufacturer's specification
Pack size & Demanded Price 100ml; Decontrolled
Me-too status Colicillin-LA Injection Baariq Pharma Reg. 087153
GMP status New Section Veterinary Liquid Injection Penicillin
Remarks of the Evaluator
Decision: Approved with innovator’s specifications.
315. Name and address of manufacturer /
Applicant
Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National
Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Moxigen Injection
Composition Each ml contains:
Minutes of 294th Meeting of Registration Board | 278
Amoxicillin Trihydrate eq. to Amoxicillin……….50mg
Gentamycin Sulphate eq. to Gentamycin…………25mg
Diary No. Date of R&I & Fee Dy. No. 21194: 18-10-2019, Rs. 20,000/-: 18-10.2019
Pharmacological Group Antibiotic
Type of Form Form-5
Finished product Specification Manufacturer's specification
Pack size & Demanded Price 50ml; Decontrolled
Me-too status G MOX 50ML INJECTION. Reg. 085493
GMP status New Section Veterinary Liquid Injection Penicillin
Remarks of the Evaluator
Decision: Approved with innovator’s specifications.
316. Name and address of manufacturer /
Applicant
Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National
Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Moxigen Injection
Composition Each ml contains:
Amoxicillin Trihydrate eq. to Amoxicillin…………….50
mg
Gentamycin Sulphate eq. to Gentamycin……….....25 mg
Diary No. Date of R&I & Fee Dy. No. 21195: 18-10-2019, Rs. 20,000/-: 18-10.2019
Pharmacological Group Antibiotic
Type of Form Form-5
Finished product Specification Manufacturer's specification
Pack size & Demanded Price 100ml; Decontrolled
Me-too status G Mox Injection (100ml). Reg. 085724
GMP status New Section Veterinary Liquid Injection Penicillin
Remarks of the Evaluator
Decision: Approved with innovator’s specifications.
317. Name and address of manufacturer /
Applicant
Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National
Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Moxiclav Injection
Composition Each ml contains:
Amoxicillin as Trihydrate………………………..140mg
Clavulanic Acid as Potassium Clavulanate………35mg
Diary No. Date of R&I & Fee Dy. No. 21196: 18-10-2019, Rs. 20,000/-: 18-10.2019
Pharmacological Group Antibiotic
Type of Form Form-5
Finished product Specification Manufacturer's specification
Pack size & Demanded Price 50ml; Decontrolled
Me-too status Clavet Injection (50ml, 100ml). Reg. 046519 (does not
depict Potassium Clavulanate salt).
GMP status New Section Veterinary Liquid Injection Penicillin
Remarks of the Evaluator Available in BP as amoxicillin and potassium clavulanate
injection.
Decision: Approved with BP specifications.
318. Name and address of manufacturer /
Applicant
Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National
Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Moxiclav Injection
Composition Each ml contains:
Amoxicillin as Trihydrate.………………………..140 mg
Clavulanic Acid as Potassium Clavulanate……….35mg
Diary No. Date of R&I & Fee Dy. No. 21197: 18-10-2019, Rs. 20,000/-: 18-10.2019
Pharmacological Group Antibiotic
Type of Form Form-5
Finished product Specification Manufacturer's specification
Minutes of 294th Meeting of Registration Board | 279
Pack size & Demanded Price 100ml; Decontrolled
Me-too status Clavet Injection (50ml, 100ml). Reg. 046519 (does not
depict Potassium Clavulanate salt).
GMP status New Section Veterinary Liquid Injection Penicillin
Remarks of the Evaluator Available in BP as amoxicillin and potassium
clavulanate injection.
Decision: Approved with BP specifications.
319. Name and address of manufacturer /
Applicant
Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National
Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Ampicot LA Injection
Composition Each ml contains:
Ampicillin as Trihydrate.…………….12.5 g
Cloxacillin Base…………..................12.5 g
Diary No. Date of R&I & Fee Dy. No. 21198: 18-10-2019, Rs. 20,000/-: 18-10.2019
Pharmacological Group Antibiotic
Type of Form Form-5
Finished product Specification Manufacturer's specification
Pack size & Demanded Price 50ml; Decontrolled
Me-too status Ampicox Injection (50ml, 100ml). Reg. 035061
GMP status New Section Veterinary Liquid Injection Penicillin
Remarks of the Evaluator
Decision: Approved with innovator’s specifications.
320. Name and address of manufacturer /
Applicant
Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National
Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Ampicot LA Injection
Composition Each ml contains:
Ampicillin as Trihydrate..…………….12.5 gm
Cloxacillin Base…………...........12.5 gm
Diary No. Date of R&I & Fee Dy. No. 21191: 18-10-2019, Rs. 20,000/-: 18-10.2019
Pharmacological Group Antibiotic
Type of Form Form-5
Finished product Specification Manufacturer's specification
Pack size & Demanded Price 100ml; Decontrolled
Me-too status Ampicox Injection (50ml, 100ml). Reg. 035061
GMP status New Section Veterinary Liquid Injection Penicillin
Remarks of the Evaluator
Decision: Approved with innovator’s specifications.
321. Name and address of manufacturer /
Applicant
Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National
Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Procapen GP Injection
Composition Each ml contains:
Penicillin G procaine ………………..300 mg
Diary No. Date of R&I & Fee Dy. No. 21200: 18-10-2019, Rs. 20,000/-: 18-10.2019
Pharmacological Group Antibiotic
Type of Form Form-5
Finished product Specification Manufacturer's specification
Pack size & Demanded Price 50ml; Decontrolled
Me-too status Nawapen-30 (10ml, 50ml, 100ml). Reg. 053996 (procaine
penicillin)
GMP status New Section Veterinary Liquid Injection Penicillin
Remarks of the Evaluator Finished product is available as Procaine penicillin G
injectable suspension in BP. The firm revised procaine
penicillin to Penicillin G procaine without submission of fee.
Decision: Deferred for submission of fee for revision of salt form.
Minutes of 294th Meeting of Registration Board | 280
322. Name and address of manufacturer /
Applicant
Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National
Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Streptocaine Injection
Composition Each ml contains:
Penicillin G procaine………………..200 mg
Dihydrostreptomycin Sulphate………...160 mg
Diary No. Date of R&I & Fee Dy. No. 21201: 18-10-2019, Rs. 20,000/-: 18-10.2019
Pharmacological Group Antibiotic
Type of Form Form-5
Finished product Specification Manufacturer's specification
Pack size & Demanded Price 50ml; Decontrolled
Me-too status Neo Strep-Pen Injection (10ml, 50ml, 100ml). Reg. 053997
(Penicillin procaine, streptomycin Sulphate)
GMP status New Section Veterinary Liquid Injection Penicillin
Remarks of the Evaluator Finished product is available as Procaine penicillin G,
dihydrostreptomycin Sulphate injectable suspension in BP.
The firm revised procaine penicillin to Penicillin G procaine
without submission of fee.
Decision: Deferred for submission of fee for revision of salt form.
323. Name and address of manufacturer /
Applicant
Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National
Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Streptocaine Injection
Composition Each ml contains:
Penicillin G procaine………………..200 mg
dihydrostreptomycin Sulphate………...160 mg
Diary No. Date of R&I & Fee Dy. No. 21202: 18-10-2019, Rs. 20,000/-: 18-10.2019
Pharmacological Group Antibiotic
Type of Form Form-5
Finished product Specification Manufacturer's specification
Pack size & Demanded Price 100ml; Decontrolled
Me-too status Neo Strep-Pen Injection (10ml, 50ml, 100ml). Reg. 053997
(Penicillin procaine, streptomycin Sulphate)
GMP status New Section Veterinary Liquid Injection Penicillin
Remarks of the Evaluator Finished product is available as Procaine penicillin G,
dihydrostreptomycin Sulphate injectable suspension in BP.
The firm revised procaine penicillin to Penicillin G procaine
without and streptomycin Sulphate to Dihydrostreptomycin
Sulphate without submission of fee.
Decision: Deferred for submission of fee for revision of salt form.
324. Name and address of manufacturer /
Applicant
Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National
Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Di-Pen Injection
Composition Each ml contains:
Procaine Penicillin G…………………200,000 IU
Dihydrostreptomycin Sulphate…………..200 mg
Diary No. Date of R&I & Fee Dy. No. 21203: 18-10-2019, Rs. 20,000/-: 18-10.2019
Pharmacological Group Antibiotic
Type of Form Form-5
Finished product Specification Manufacturer's specification
Pack size & Demanded Price 50ml; Decontrolled
Me-too status Streptomet (50ml). Reg. 080954
GMP status New Section Veterinary Liquid Injection Penicillin
Minutes of 294th Meeting of Registration Board | 281
Remarks of the Evaluator Finished product is available as Procaine penicillin G,
dihydrostreptomycin Sulphate injectable suspension in BP.
Decision: Approved with BP specifications.
325. Name and address of manufacturer /
Applicant
Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National
Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Tri-Pen LA Injection
Composition Each ml contains:
Benzathine Pencillin G.…..………….100,000 IU
Procaine Penicillin G………………..150,000 IU
Dihydrostreptomycin sulphate…………..200 mg
Diary No. Date of R&I & Fee Dy. No. 21204: 18-10-2019, Rs. 20,000/-: 18-10.2019
Pharmacological Group Antibiotic
Type of Form Form-5
Finished product Specification Manufacturer's specification
Pack size & Demanded Price 50ml; Decontrolled
Me-too status BPS-LA Injection (50ml). Reg. 080951
GMP status New Section Veterinary Liquid Injection Penicillin
Remarks of the Evaluator Revise “Dihydrostreptomycin sulphate” to
“Dihydrostreptomycin as sulphate” in the label claim only and
adjust the weight of Dihydrostreptomycin sulphate in Master
formula as per salt factor.
Decision: Deferred for revision of formulation including the salt form as per the DRAP approved
generic product along with submission of revised master formulation and requisite fee.
Item No. 10: Agenda of Evaluator PEC-XI
M/s D.Hanns Pharma (Pvt) Ltd., Plot No. 9/A, Industrial Estate, Bhimber, AJK.
The Central Licensing Board in its 273rd meeting held on 15th January, 2020 has considered and approved the
grant of Drug Manufacturing License to M/s D.Hanns Pharma (Pvt) Ltd., Plot No. 9/A, Industrial Estate, Bhimber,
AJK. by way of Formulation vide approval letter No. F. 1-18/2018-Lic dated 11th February 2020 with following
(04) sections.
S No. Section No. of products No. of Molecules
1. Oral Liquid Section-I (Vet) 28 10
2. Oral Liquid Section-II (Vet) 21 10
3. Oral Powder Section-I (Vet) N/A N/A
4. Oral Powder Section-II (Vet) N/A N/A
Following applications have been submitted for registration by the firm.
Oral Liquid Section-I (10molecules / 28products)
326. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber, AJK.
Brand Name, Dosage Form, Strength FEN HANS 23 % ORAL LIQUID
Composition Each 100ml contains:-
Florfenicol ………………… 23g
Colistin Sulphate…………50MIU
Diary No., Date of R & I & Fee Dy.No 1511 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Antibiotic
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml,150ml, 250ml,500ml,1Litre, 2.5Litre; Decontrolled
Me-Too Status Fentin-23 by M/s Nawal Pharmaceuticals (Reg#078257)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Minutes of 294th Meeting of Registration Board | 282
Remarks of Evaluator XI The firm has claimed manufacturer’s specifications and the
product is not present in available pharmacopoeia (USP,BP,IP,JP)
Decision: Approved with innovator’s specification.
327. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber, AJK.
Brand Name, Dosage Form, Strength FEN HANS 25 % ORAL LIQUID
Composition Each 100ml contains:-
Florfenicol ………………… 25g
Colistin Sulphate…………50MIU
Diary No., Date of R & I & Fee Dy.No 1512 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Antibiotic
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml,150ml, 250ml,500ml,1Litre,2.5Litre Decontrolled
Me-Too Status Flocol Liquid by M/s D-Maarson Pharmaceuticals (Reg#074082)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator XI The firm has claimed manufacturer’s specifications & the product
is not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Deferred for scientific rational for formulation containing 25g/100ml florfenicol, since
formulation containing 23g/100ml florfenicol is already approved.
328. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength FEN HANS 11% ORAL LIQUID
Composition Each 100ml contains:-
Florfenicol ………………… 11g
Colistin Sulphate…………50MIU
Diary No., Date of R & I & Fee Dy.No 1513 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Antibiotic
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml,150ml, 250ml, 500ml, 1Litre, 2.5Litre Decontrolled
Me-Too Status Flo Raft Oral Liquid by M/s Nawal Pharmaceuticals
(Reg#078252)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator XI The firm has claimed manufacturer’s specifications & the product
is not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Deferred for scientific rational for formulation containing 11g/100ml florfenicol, since
formulation containing 10g/100ml florfenicol is already approved.
329. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength FEN HANS 10 % ORAL LIQUID
Composition Each 100ml contains:-
Florfenicol ………………… 10g
Colistin Sulphate…………50MIU
Diary No., Date of R & I & Fee Dy.No 1514 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Antibiotic
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml,150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Floro C Oral Liquid by M/s D-Maarson Pharmaceuticals
(Reg#074079)
Minutes of 294th Meeting of Registration Board | 283
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator XI The firm has claimed manufacturer’s specifications & product is
not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
330. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength FLOHANS-23% ORAL LIQUID
Composition Each 100ml contains:-
Florfenicol ………………… 23g
Diary No., Date of R & I & Fee Dy.No 1515 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Antibiotic
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml,150ml, 250ml,500ml,1Litre, 2.5Litre; Decontrolled
Me-Too Status Floral Plus Oral Liquid by M/s Nawal Pharmaceuticals
(Reg#074090)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator XI The firm has claimed manufacturer’s specifications & product is
not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
331. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength FLOHANS-25 % ORAL LIQUID
Composition Each 100ml contains:-
Florfenicol ………………… 25g
Diary No., Date of R & I & Fee Dy.No 1516 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Antibiotic
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml,150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Wal-Fen 25% Oral Liquid by M/s Nawal Pharmaceuticals
(Reg#099438)…could not be confirmed
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator XI Evidence of applied formulation/drug already approved by DRAP
(generic/me-too status) alongwith registration number, brand
name and name of firm could not be confirmed
The firm has claimed manufacturer’s specifications & product is
not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Deferred for following:
Scientific rational for formulation containing 25g/100ml florfenicol, since formulation
containing 23g/100ml florfenicol is already approved.
Evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
alongwith registration number, brand name and name of firm.
332. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength FLOHANS-20% ORAL LIQUID
Composition Each 100ml contains:-
Florfenicol ………………… 20g
Diary No., Date of R & I & Fee Dy.No 1517 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Antibiotic
Type Of Form Form 5
Minutes of 294th Meeting of Registration Board | 284
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Florfen-20% Oral Liquid by M/s Nawal Pharma (Reg#074091)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator XI The firm has claimed manufacturer’s specifications & product is
not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
333. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength FLOHANS-10% ORAL LIQUID
Composition Each 100ml contains:-
Florfenicol ………………… 10g
Diary No., Date of R & I & Fee Dy.No 1518 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Antibiotic
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml,150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Fencol-10% Oral Liquid by M/s Nawal Pharma (Reg#075741)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed manufacturer’s specifications & product is
not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
334. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength TIMBER ORAL LIQUID
Composition Each ml contains:-
Tilmicosin Phosphate…………… 250mg
Diary No., Date of R & I & Fee Dy.No 1519 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Antibiotic
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml,150ml, 250ml,500ml,1Litre, 2.5Litre Decontrolled
Me-Too Status Tico-Maars Oral Liquid by M/s D-Maarson Pharmaceuticals
(Reg#096841)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed manufacturer’s specifications & product is
not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
335. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength TIMBER-PL ORAL LIQUID
Composition Each ml contains:-
Tilmicosin…………… 250mg
Diary No., Date of R & I & Fee Dy.No 1520 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Antibiotic
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml,150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Tilconoor 2.5% Oral Liquid by M/s Kohinoor Industries
(Reg#081312)
Minutes of 294th Meeting of Registration Board | 285
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has already applied the same product, in same strength
and same dosage form with salt form.
The firm has claimed manufacturer’s specifications & product is
not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Deferred for clarification since the same product in same strength and dosage form (with
salt form) is also applied.
336. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A,Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength GUXANIN-AG ORAL LIQUID
Composition Each 100ml contains:-
Enrofloxacin …… ……… 10g
Guaifenesin………………10g
Aminophylline………….. ..4g
Diary No., Date of R & I & Fee Dy.No 1521 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Antibiotic, Bronchodilator, Expectorant
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml,150ml, 250ml,500ml,1Litre, 2.5Litre Decontrolled
Me-Too Status EG Enro Plus Liquid by M/s Elegance Pharma (Reg#074099)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed manufacturer’s specifications & product is
not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
337. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength GUNAXIN-AE ORAL LIQUID
Composition Each 100ml contains:-
Enrofloxacin …… ……… 10g
Guaifenesin………………..4g
Aminophylline………….. ..10g
Diary No., Date of R & I & Fee Dy.No 1522 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Antibiotic, Bronchodilator, Expectorant
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml,150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Ensol-AG Oral Liquid By M/s Biogen Pharma (Reg#049720)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed manufacturer’s specifications & product is
not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
338. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength SUNRO-E10 ORAL LIQUID
Composition Each 100ml contains:-
Enrofloxacin …… ……… 10g
Colistin Sulphate…………50MIU
Diary No., Date of R & I & Fee Dy.No 1523 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Antibiotic
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Minutes of 294th Meeting of Registration Board | 286
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Amtin-C Oral Liquid by M/s D-Maarson Pharma (Reg#074080)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed manufacturer’s specifications & product is
not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
339. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength SUNRO-E20 ORAL LIQUID
Composition Each 100ml contains:-
Enrofloxacin …… ……… 20g
Colistin Sulphate…………50MIU
Diary No., Date of R & I & Fee Dy.No 1524 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Antibiotic
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Maxen Liquid by M/s D-Maarson Pharmaceuticals (Reg#075749)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed manufacturer’s specifications & product is
not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
340. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength SUNRO-E25 ORAL LIQUID
Composition Each 100ml contains:-
Enrofloxacin …… ……… 25g
Colistin Sulphate…………50MIU
Diary No., Date of R & I & Fee Dy.No 1525 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Antibiotic
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Vetaflox-C 25% Oral Liquid by M/s Vetz Pharmaceuticals
(Reg#079276)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed manufacturer’s specifications & product is
not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
341. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength SUNRO-E ORAL LIQUID
Composition Each 100ml contains:-
Enrofloxacin …… ……… 20g
Colistin Sulphate…………3%
Diary No., Date of R & I & Fee Dy.No 1526 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Antibiotic
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 450ml, 500ml, 1Litre, 2.5Litre;
Decontrolled
Minutes of 294th Meeting of Registration Board | 287
Me-Too Status Enrosir-20 Oral Liquid (Enrofloxacin 20%,
Colistin Sulphate 3%) by M/s Attabak Pharma (Reg#071060)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed manufacturer’s specifications & product is
not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
342. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength HEXBRO-10 ORAL LIQUID
Composition Each ml contains:-
Bromhexine HCl…… ……… 10mg
Diary No., Date of R & I & Fee Dy.No 1527 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Mucolytics
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml,150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Wal-Bro-100 Liquid by M/s Nawal Pharmaceuticals
(Reg#097863)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed manufacturer’s specifications & product is
not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
343. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength HEXBRO-50 ORAL LIQUID
Composition Each ml contains:-
Bromhexine HCl…………… 50mg
Diary No., Date of R & I & Fee Dy.No 1528 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Mucolytics
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Wal-Bro-50 Liquid by M/s Nawal Pharmaceuticals
(Reg#097862)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed manufacturer’s specifications & product is
not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
344. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength AMI-HANS ORAL LIQUID
Composition Each 100ml contains:-
Doxycycline HCl ………………… 20g
Tylosin tartrate ……………….…. 10g
Guaifenesin ….…………………. 20g
Aminophylline ………………… 8g
Diary No., Date of R & I & Fee Dy.No 1529 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Antibiotic, Expectorant, Bronchodilator
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre; Decontrolled
Minutes of 294th Meeting of Registration Board | 288
Me-Too Status Tyco-G Oral Liquid by M/s Attabak Pharmaceuticals
(Reg#075704)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has not revised the label claim as per approved Mee-Too
product alongwith submission of applicable fee. The strength of
molecules of the applied product is different as compared to
approved Mee-Too product.
The firm has claimed manufacturer’s specifications & product is
not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Deferred for revision of formulation as per DRAP approved me-too / generic product
along with submission of requisite fee.
345. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength BIMRO-10 ORAL LIQUID
Composition Each 100ml contains:-
Enrofloxacin …… ……… 10g
Diary No., Date of R & I & Fee Dy.No 1530 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Antibiotic
Type Of Form Form 5
Finished product Specification USP
Pack Size and Demanded Price 100ml, 150ml, 250ml, 450ml, 500ml, 1Litre, 2.5Litre;
Decontrolled
Me-Too Status Enrowal-10 Oral Liquid by M/s Nawal Pharma (Reg#072626)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed for manufacturer’s specifications but the
product is present in USP as oral suspension
Decision: Approved with USP specification.
346. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength BIMRO-20 ORAL LIQUID
Composition Each 100ml contains:-
Enrofloxacin …………… 20g
Diary No., Date of R & I & Fee Dy.No 1531 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Antibiotic
Type Of Form Form 5
Finished product Specification USP
Pack Size and Demanded Price 100ml, 150ml, 250ml, 450ml, 500ml, 1Litre, 2.5Litre;
Decontrolled
Me-Too Status Enrowal-20 Oral Liquid by M/s Nawal Pharmaceuticals
(Reg#072627)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed for manufacturer’s specifications but the
product is present in USP as oral suspension
Decision: Approved with USP specification.
347. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength BIMRO-25 ORAL LIQUID
Composition Each 100ml contains:-
Enrofloxacin …………… 25g
Diary No., Date of R & I & Fee Dy.No 1532 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Antibiotic
Minutes of 294th Meeting of Registration Board | 289
Type Of Form Form 5
Finished product Specification USP
Pack Size and Demanded Price 100ml, 150ml, 250ml, 450ml, 500ml, 1Litre, 2.5Litre;
Decontrolled
Me-Too Status Enro-Gold Liquid by M/s Medicure Laboratories (Reg#058961)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed for manufacturer’s specifications but the
product is present in USP as oral suspension
Decision: Approved with USP specification.
348. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength MENTOVET-54 ORAL LIQUID
Composition Each ml contains:-
Bromhexine HCl…… ……… 50mg
Menthol………………………..40mg
Diary No., Date of R & I & Fee Dy.No 1533 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Mucolytics, Expectorant
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Hexthol Liquid by M/s Nawal Pharmaceuticals (Reg#097984)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed manufacturer’s specifications & product is
not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
349. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength MENTOVET-24 ORAL LIQUID
Composition Each ml contains:-
Bromhexine HCl…………… 20mg
Menthol……………………..40mg
Diary No., Date of R & I & Fee Dy.No 1534 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Mucolytics, Expectorant
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Bromo-Plus Liquid by Elegance Pharmaceuticals (Reg#073917)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed manufacturer’s specifications & product is
not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
350. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength MENTOVET-12 ORAL LIQUID
Composition Each ml contains:-
Bromhexine HCl…………… 10mg
Menthol……………..……….20mg
Diary No., Date of R & I & Fee Dy.No 1535 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Mucolytic, Expectorant
Type Of Form Form 5
Minutes of 294th Meeting of Registration Board | 290
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Bromotin Liquid by M/s Elegance Pharmaceuticals
(Reg#073999)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed manufacturer’s specifications & product is
not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
351. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength BRO DOX-CT ORAL LIQUID
Composition Each1000 ml contains:-
Doxycycline HCl ………………… 200g
Tylosin tartrate ……………….…. 100g
Colistin Sulphate…………………. 500MIU
Bromhexine HCl….…………………10g
Diary No., Date of R & I & Fee Dy.No 1536 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Antibiotic, Mucolytic
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre; Decontrolled
Me-Too Status CRD Liquid by M/s D-Maarson Pharmaceuticals (Reg#072678)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed manufacturer’s specifications & product is
not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
352. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength BRO DOX-C ORAL LIQUID
Composition Each 1000ml contains:-
Doxycycline HCl ………………… 200g
Tylosin tartrate ……………….…. 200g
Colistin Sulphate…………………. 500MIU
Bromhexine HCl….……………….. 5g
Diary No., Date of R & I & Fee Dy.No 1537 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Antibiotic, Mucolytic
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre; Decontrolled
Me-Too Status CRD Mars Liquid by M/s D-Maarson Pharmaceuticals
(Reg#072677)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed manufacturer’s specifications & product is
not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
353. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength BRO DOX-5 ORAL LIQUID
Composition Each 1000ml contains:-
Doxycycline HCl ………………… 200g
Tylosin tartrate ……………….…. 100g
Minutes of 294th Meeting of Registration Board | 291
Colistin Sulphate…………………. 500MIU
Bromhexine HCl….………………. 5g
Diary No., Date of R & I & Fee Dy.No 1538 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Antibiotic, Mucolytic
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre; Decontrolled
Me-Too Status CRD-COL Oral Liquid by M/s Attabak Pharma (Reg#058879)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed manufacturer’s specifications & product is
not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
Oral Liquid Section-II (10 molecules/21 products)
354. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength COBAZASOL DS ORAL SUSPENSION
Composition Each 100ml contains:-
Oxyclozanide ………………… 6%
Levamisole HCl ……………… 3%
Cobalt Chloride………………. 0.15%
Sodium selenite ………………. 0.07%
Diary No., Date of R & I & Fee Dy.No 2031 dated 19/02/2020; Rs. 20,000 19/02/2020
Pharmacological Group Anthelmintic, Minerals
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator Evidence of applied formulation already approved by DRAP
(generic/me-too status) alongwith registration number, brand name
and name of firm not available
The firm has claimed manufacturer’s specifications & the product
is not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic /
me-too status) alongwith registration number, brand name and name of firm.
355. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength COBAZASOL-PL ORAL SUSPENSION
Composition Each 100ml contains:-
Oxyclozanide ………………… 3g
Levamisole HCl ……………… 1.5g
Cobalt Chloride…………… 0.075g
Sodium selenite …………… 0.035g
Diary No., Date of R & I & Fee Dy.No 2032 dated 19/02/2020; Rs. 20,000 19/02/2020
Pharmacological Group Anthelmintic, Minerals
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Nilzole Liquid by M/s Attabak Pharmaceuticals (Reg#034545)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Minutes of 294th Meeting of Registration Board | 292
Remarks of Evaluator The firm has claimed manufacturer’s specifications and product is
not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
356. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength LEVA BALT ORAL SUSPENSION
Composition Each 100ml contains:-
Triclabendazole ………………… 5g
Levamisole HCl ……………… 3.75g
Cobalt sulphate ………………. 0.075g
Sodium selenite ………………. 0.035g
Diary No., Date of R & I & Fee Dy.No 2033 dated 19/02/2020; Rs. 20,000 19/02/2020
Pharmacological Group Anthelmintic, Minerals
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Tenex plus 8.75 Drench by M/s Breeze Pharma (Reg#059107)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator Mee-Too of applied product shows the base form of Levamisole
while the applied formulation contains the hydrochloride salt of
Levamisole. Moreover Mee-Too of applied product shows the
chloride salt of cobalt while the applied formulation contains the
sulphate salt of cobalt. Clarify or revise the salt form of Levamisole
and cobalt in the label claim and master formulation along with
submission of applicable fee.
The firm has claimed manufacturer’s specifications & the product
is not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Deferred for revision of formulation as per DRAP approved me-too / generic product along
with submission of requisite fee.
357. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength LEVA BALT-PLUS ORAL SUSPENSION
Composition Each ml contains:-
Triclabendazole …………… 50mg
Levamisole as HCl ……………37.5mg
Cobalt sulphate ……………. 1.67mg
Sodium selenite ……………. 0.35mg
Diary No., Date of R & I & Fee Dy.No 2034 dated 19/02/2020; Rs. 20,000 19/02/2020
Pharmacological Group Anthelmintic, Minerals
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Triclobak plus suspension by M/s Attabak Pharmaceuticals
(Reg#062168)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has submitted revised form 5 correcting the salt of
Levamisole in label claim as per Mee-Too product along with
submission of Rs. 5000/- on deposit slip No. 1927781 date
06.04.2020.
The firm has claimed manufacturer’s specifications & product is
not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
Minutes of 294th Meeting of Registration Board | 293
358. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength LEVA BALT-AD ORAL SUSPENSION
Composition Each ml contains:-
Triclabendazole ………….. 50mg
Levamisole HCl ………..… 37.5mg
Cobalt sulphate …………… 0.075g
Sodium selenite …………… 0.035g
Diary No., Date of R & I & Fee Dy.No 2035 dated 19/02/2020; Rs. 20,000 19/02/2020
Pharmacological Group Anthelmintic, Minerals
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Cobzolewal Oral Suspension by M/s Nawal Pharmaceuticals
(Reg#097904)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed manufacturer’s specifications & the product
is not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
359. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength HANSENID ORAL SUSPENSION
Composition Each 100ml contains:-
Oxfendazole……….2.265gm
Diary No., Date of R & I & Fee Dy.No 2036 dated 19/02/2020; Rs. 20,000 19/02/2020
Pharmacological Group Anthelmintic
Type Of Form Form 5
Finished product Specification USP
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Oxafen Oral Suspension by M/s Farm Aid Group Pak
(Reg#041250)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed BP specifications (product not available) but
the product is in available US pharmacopoeia.
Decision: Approved with USP specification.
360. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength HANSENID–PL ORAL SUSPENSION
Composition Each ml contains:-
Oxfendazole…………...25mg
Diary No., Date of R & I & Fee Dy.No 2037 dated 19/02/2020; Rs. 20,000 19/02/2020
Pharmacological Group Anthelmintic
Type Of Form Form 5
Finished product Specification USP
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Arox Drench by M/s Leads Pharma (Reg#046670)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Minutes of 294th Meeting of Registration Board | 294
Remarks of Evaluator The firm has submitted revised form 5 correcting the strength in
label claim as per Mee-Too product along with submission of Rs.
5000/- on deposit slip No. 1927782 date 06.04.2020
The firm has claimed BP specifications (product not available) but
the product is in available US pharmacopoeia.
Decision: Deferred for submission of fee Rs 15,000/- for revision of formulation.
361. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength HAN-FAXS ORAL SUSPENSION
Composition Each 100ml contains:-
Triclabendazole……….. 12g
Albendazole…………… 10g
Ivermectin…………….. 0.2g
Diary No., Date of R & I & Fee Dy.No 2038 dated 19/02/2020; Rs. 20,000 19/02/2020
Pharmacological Group Anthelmintic
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Thunder Drench by M/s Star Laboratories (Reg#058941)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed manufacturer’s specifications & the product
is not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
362. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength TRILOXAL ORAL SUSPENSION
Composition Each 100ml contains:-
Triclabendazole……….8.5g
Oxfendazole………...…2.265g
Diary No., Date of R & I & Fee Dy.No 2039 dated 19/02/2020; Rs. 20,000 19/02/2020
Pharmacological Group Anthelmintic
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Vorcid Suspension by Breeze Pharma (Reg#063563)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has submitted revised form 5 correcting the strength of
oxfendazole in label claim as per Mee-Too product along with
submission of Rs. 20,000/- on deposit slip No. 1927783 date
06.04.2020
The firm has claimed manufacturer’s specifications & the product
is not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
363. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength AUG-MILK ORAL SUSPENSION
Composition Each ml contains:-
Oxyclozanide………….62.5mg
Oxfendazole……………22.65mg.
Cobalt Sulphate……….1.67mg
Selenium as Sodium Selenate………..0.5mg
Diary No., Date of R & I & Fee Dy.No 2040 dated 19/02/2020; Rs. 20,000 19/02/2020
Minutes of 294th Meeting of Registration Board | 295
Pharmacological Group Anthelmintic
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status O-2 Forte Suspension by M/s D-Maarson Pharma (Reg#078264)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed manufacturer’s specifications & the product
is not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
364. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength HANZOLE 2.5% ORAL SUSPENSION
Composition Each 100ml contains:-
Albendazole……………2.5g.
Diary No., Date of R & I & Fee Dy.No 2041 dated 19/02/2020; Rs. 20,000 19/02/2020
Pharmacological Group Anthelmintic
Type Of Form Form 5
Finished product Specification USP
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Albabak-2.5 Oral Suspension by M/s Attabak Pharmaceuticals
(Reg#034538)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed for manufacturer’s specifications but the
product is present in USP as oral suspension
Decision: Approved with USP specification.
365. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength HANZOLE 5% ORAL SUSPENSION
Composition Each 100ml contains:-
Albendazole……………5g.
Diary No., Date of R & I & Fee Dy.No 2021 dated 19/02/2020; Rs. 20,000 19/02/2020
Pharmacological Group Anthelmintic
Type Of Form Form 5
Finished product Specification USP
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Albanil Suspension by M/s Farm Aid Group Pak (Reg#035199)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed for manufacturer’s specifications but the
product is present in USP as oral suspension
Decision: Approved with USP specification.
366. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength HANZOLE 10% ORAL SUSPENSION
Composition Each 100ml contains:-
Albendazole……………10g.
Diary No., Date of R & I & Fee Dy.No 2022 dated 19/02/2020; Rs. 20,000 19/02/2020
Pharmacological Group Anthelmintic
Type Of Form Form 5
Finished product Specification USP
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Minutes of 294th Meeting of Registration Board | 296
Me-Too Status Bendol 10 Suspension by M/s Breeze Pharma (Reg#059153)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed for manufacturer’s specifications but the
product is present in USP as oral suspension
Decision: Approved with USP specification.
367. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength HANZOLE 12.5% ORAL SUSPENSION
Composition Each 100ml contains:-
Albendazole……………12.5g
Diary No., Date of R & I & Fee Dy.No 2023 dated 19/02/2020; Rs. 20,000 19/02/2020
Pharmacological Group Anthelmintic
Type Of Form Form 5
Finished product Specification USP
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Albadec Super Oral Suspension by M/s Decent Pharma (R#079838)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed for manufacturer’s specifications but the
product is present in USP as oral suspension
Decision: Deferred for scientific rational for formulation containing 12.5g/100ml albendazole, since
formulation containing 10g/100ml albendazole is already approved.
368. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength HANZOLE-11.25% ORAL SUSPENSION
Composition Each 100ml contains:-
Albendazole……………11.25g.
Diary No., Date of R & I & Fee Dy.No 2024 dated 19/02/2020; Rs. 20,000 19/02/2020
Pharmacological Group Anthelmintic
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Albensure Drench by M/s Biogen Pharma (Reg#069609)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed for manufacturer’s specifications but the
product is present in USP as oral suspension
Decision: Deferred for scientific rational for formulation containing 11.25g/100ml albendazole, since
formulation containing 10g/100ml albendazole is already approved.
369. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength ALBAHANS ORAL SUSPENSION.
Composition Each 100ml contains:-
Albendazole……………2.5g
Cobalt Sulphate……….0.075g
Sodium Selenite………..0.035g
Diary No., Date of R & I & Fee Dy.No 2025 dated 19/02/2020; Rs. 20,000 19/02/2020
Pharmacological Group Anthelmintic
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Minutes of 294th Meeting of Registration Board | 297
Me-Too Status Nobialba Suspension by M/s Noble Pharma (Reg#62124)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed manufacturer’s specifications & the product
is not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
370. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength ALBAHANS-10% ORAL SUSPENSION
Composition Each 100ml contains:-
Albendazole……………10g
Cobalt Sulphate……….0.075g
Sodium Selenite………..0.035g
Diary No., Date of R & I & Fee Dy.No 2026 dated 19/02/2020; Rs. 20,000 19/02/2020
Pharmacological Group Anthelmintic
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator Evidence of applied formulation already approved by DRAP
(generic/me-too status) alongwith registration number, brand name
and name of firm not available
The firm has claimed manufacturer’s specifications & the product
is not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic /
me-too status) alongwith registration number, brand name and name of firm.
371. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength ALBAHANS-12.5% ORAL SUSPENSION
Composition Each 100ml contains:-
Albendazole……………12.5g
Cobalt Sulphate……….0.075g
Sodium Selenite………..0.035g
Diary No., Date of R & I & Fee Dy.No 2027 dated 19/02/2020; Rs. 20,000 19/02/2020
Pharmacological Group Anthelmintic
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator Evidence of applied formulation already approved by DRAP
(generic/me-too status) alongwith registration number, brand name
and name of firm is not available
The firm has claimed manufacturer’s specifications & the product
is not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic /
me-too status) alongwith registration number, brand name and name of firm.
372. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength ALBAHANS-7.5% ORAL SUSPENSION
Composition Each 100ml contains:-
Minutes of 294th Meeting of Registration Board | 298
Albendazole……………7.5%
Cobalt Sulphate……….0.075%
Sodium Selenite………..0.035%
Diary No., Date of R & I & Fee Dy.No 2028 dated 19/02/2020; Rs. 20,000 19/02/2020
Pharmacological Group Anthelmintic
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status Albamont Oral Suspension by Westmont Pharma (Reg#048194)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator The firm has claimed manufacturer’s specifications & the product
is not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Approved with innovator’s specification.
373. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength HISO-VIT LIQUID
Composition Each ml contains:-
Sulphadiazine………………. 35.50 gm
Sulphadimidine…………... 28.40 gm
Neomycin Sulphate……….. 1.80 gm
Hysocine Methylbromide…. 0.04 gm
Pectin……………………….. 7.10 gm
Kaoline…………………….. 103.30 gm
Vitamin B1………………… 0.15 gm
Vitamin B2…………………. 0.22 gm
Diary No., Date of R & I & Fee Dy.No 2029 dated 19/02/2020; Rs. 20,000 19/02/2020
Pharmacological Group Antibiotics, Anti-diarrheal, Vitamins
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator Evidence of applied formulation already approved by DRAP
(generic/me-too status) alongwith registration number, brand name
and name of firm is not available
The firm has claimed manufacturer’s specifications & the product
is not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic /
me-too status) alongwith registration number, brand name and name of firm.
374. Name and address of Manufacturer
/ Applicant
D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial Estate,
Bhimber. AJK.
Brand Name, Dosage Form, Strength PEFROX-BH ORAL LIQUID
Composition Each Litre contains:-
Pefloxacin methanesulfonate equ. to
Pefloxacin…………... 100 gm
Diary No., Date of R & I & Fee Dy.No 2030 dated 19/02/2020; Rs. 20,000 19/02/2020
Pharmacological Group Fluoroquinolones
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 150ml, 250ml, 450ml, 500ml, 1Litre, 2.5Litre; Decontrolled
Me-Too Status
Minutes of 294th Meeting of Registration Board | 299
Item No. 11: Agenda of Evaluator PEC-XIV
Case no. 01 Registration applications of drugs for which stability study data is submitted
a. Verification of stability study data
Sr.
No.
Name & Address of
Manufacturer /
Applicant
Brand Name
(Proprietary Name + Dosage
Form + Strength), Composition,
Pharmacological Group,
Finished Product Specification
Type of Form,
Initial Diary &
Date, Fee
(including
differential fee),
Demanded Price /
Pack size
International Availability /
Local Availability
GMP Inspection Report
Date & Remarks
375. M/s Ferozsons
Laboratories Ltd., P.O
Ferozsons, Amangarh,
Nowshera-Khyber
Pakhtunkhwa
EMPAGEN Tablet 10mg
Each film coated tablet contains:
Empagliflozin…..10mg
Sodium Glucose Co-Transporter
2 Inhibitor
In-house specifications
Form 5
Dy.No.10160
dated
04-03-2019
Rs. 20,000/-
dated
27-02-2019
As per DRAP
Policy
Jardiance 10mg Tablet by
Boehinger Ingelheim,
(USFDA approved)
Emazin 10mg Tablet of
Atco
Panel inspection dated 25-
01-2019 concluded that the
panel recommends the grant
of GMP certificate.
STABILITY STUDY DATA
Drug EMPAGEN TABLET 10mg
Name of Manufacturer M/s Ferozsons Laboratories Ltd., P.O Ferozsons, Amangarh, Nowshera-Khyber
Pakhtunkhwa
Manufacturer of API M/s Fuxin Long Rui Pharmaceutical Co., Ltd , China
API Lot No. E-20180425-D01-E06-01
Description of Pack
(Container closure system) Alu-Alu Blister Foil
Stability Storage Condition Real time : 30°C ± 2°C / 65% ± 5% RH
Accelerated: 40°C ± 2°C/ 75% ± 5% RH
Time Period Real time: 6 months Accelerated: 6 months
Frequency Accelerated : 0 , 3, 6 (months) Real Time: 0 , 3, 6 (Months)
Batch No. EGTab-001 EGTab-002 EGTab-003
Batch Size 1500 Tablets 1500 Tablets 1500 Tablets
Manufacturing Date 07-2018 07-2018 07-2018
Date of Initiation 24-09-2018 24-09-2018 04-09-2018
No. of Batches 03
Date of Submission 3802 (17/04/2019)
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
GMP Status New DML (No. 000912) issued on 11-02-2020 on the basis of
inspection conducted on 12-12-2019.
Remarks of Evaluator Evidence of applied formulation already approved by DRAP
(generic/me-too status) alongwith registration number, brand name
and name of firm is no available
The firm has claimed manufacturer’s specifications & the product
is not present in available pharmacopoeia (USP, BP, IP, JP)
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic /
me-too status) alongwith registration number, brand name and name of firm.
Minutes of 294th Meeting of Registration Board | 300
Sr.# Documents To Be Provided Status
1. COA of API Copy of COA (Batch # E-20180425-D01-E06-
01) from M/s M/s Fuxin Long Rui
Pharmaceutical Co., Ltd China is submitted.
2. Approval of API by regulatory authority of country of
origin or GMP certificate of API manufacturer issued by
regulatory authority of country of origin.
The firm has submitted copy of GMP certificate
of Fuxin Long Rui Pharmaceutical Co., Ltd
China issued by Fuxin Food and Drug
Administration. The certificate is valid till 19-
09-2019.
3. Protocols followed for conduction of stability study and
details of tests. Yes
4. Data of 03 batches will be supported by attested respective
documents like chromatograms, laboratory reports, data
sheets etc. Yes
5. Documents confirming import of API etc. The firm has submitted copy of Form-6 for the
purchase of Empagliflozin (650 g) attested by
Assistant Director (I & E) DRAP, Peshawar
dated 13-01-2018. The submitted copy of
commercial invoice is not attested.
6. All provided documents will be attested (name, sign and
stamp) for ensuring authenticity of data / documents. Yes
7. Commitment to continue real time stability study till
assigned shelf life of the product. Yes
8. Commitment to follow Drug Specification Rules, 1978. Yes
REMARKS OF EVALUATOR
The firm has submitted 6 months accelerated and 6 months real time stability data of three batches.
Sr.
No.
Name & Address of
Manufacturer /
Applicant
Brand Name
(Proprietary Name + Dosage
Form + Strength), Composition,
Pharmacological Group,
Finished Product Specification
Type of Form,
Initial Diary &
Date, Fee
(including
differential fee),
Demanded Price /
Pack size
International Availability /
Local Availability
GMP Inspection Report
Date & Remarks
376. M/s Ferozsons
Laboratories Ltd., P.O
Ferozsons, Amangarh,
Nowshera-Khyber
Pakhtunkhwa
EMPAGEN TABLET 25mg
Each film coated tablet contains:
Empagliflozin……..25mg
Sodium Glucose Co-Transporter
2 Inhibitor
In-house specifications
Form 5
Dy.No. 10161
dated
04-03-2019
Rs.20,000/- dated
27-02-2019
As per DRAP
Policy
Jardiance 25mg Tablet by
Boehinger Ingelheim,
(USFDA approved) Emazin 25mg Tablet of
Atco Labs.Ltd.
Panel inspection dated 25-
01-2019 concluded that the
panel recommends the grant
of GMP certificate.
STABILITY STUDY DATA
Drug EMPAGEN TABLET 25mg
Name of Manufacturer M/s Ferozsons Laboratories Ltd., P.O Ferozsons, Amangarh, Nowshera-Khyber
Pakhtunkhwa
Manufacturer of API M/s Fuxin Long Rui Pharmaceutical Co., Ltd , China
API Lot No. E-20180425-D01-E06-01
Description of Pack Alu-Alu Blister Foil
Minutes of 294th Meeting of Registration Board | 301
(Container closure system)
Stability Storage Condition Real time : 30°C ± 2°C / 65% ± 5% RH
Accelerated: 40°C ± 2°C/ 75% ± 5% RH
Time Period Real time: 6 months Accelerated: 6 months
Frequency Accelerated : 0 , 3, 6 (months) Real Time: 0 , 3, 6 (Months)
Batch No. EGTab-004 EGTab-005 EGTab-006
Batch Size 1500 Tablets 1500 Tablets 1500 Tablets
Manufacturing Date 07-2018 07-2018 07-2018
Date of Initiation 06-09-2018 06-09-2018 06-09-2018
No. of Batches 03
Date of Submission 3803 (17/04/2019)
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr.# Documents To Be Provided Status
1. COA of API Copy of COA (Batch # E-20180425-D01-E06-
01) from M/s M/s Fuxin Long Rui
Pharmaceutical Co., Ltd China is submitted.
2. Approval of API by regulatory authority of country of
origin or GMP certificate of API manufacturer issued by
regulatory authority of country of origin.
The firm has submitted copy of GMP certificate
of Fuxin Long Rui Pharmaceutical Co., Ltd
China issued by Fuxin Food and Drug
Administration. The certificate is valid till 19-
09-2019.
3. Protocols followed for conduction of stability study and
details of tests. Yes
4. Data of 03 batches will be supported by attested respective
documents like chromatograms, laboratory reports, data
sheets etc. Yes
5. Documents confirming import of API etc. The firm has submitted copy of Form-6 for the
purchase of Empagliflozin (650 g) attested by
Assistant Director (I & E) DRAP, Peshawar
dated 13-01-2018. The submitted copy of
commercial invoice is not attested.
6. All provided documents will be attested (name, sign and
stamp) for ensuring authenticity of data / documents. Yes
7. Commitment to continue real time stability study till
assigned shelf life of the product. Yes
8. Commitment to follow Drug Specification Rules, 1978. Yes
REMARKS OF EVALUATOR
The firm has submitted 6 months accelerated and 6 months real time stability data of three batches.
Minutes of 294th Meeting of Registration Board | 302
Verification of Authenticity of Stability Data submitted for Registration of Empagen 10mg and 25mg
Tablet (Empagliflozin) by M/s Ferozesons Laboratories Ltd, Nowshera
Inspection date: 25th October, 2019
Inspection site: Factory Premises of M/s Ferozsons Laboratories Nowshera.
The constituted Panel for the verification of authenticity of stability data was comprised of the following members,
1. Dr. Jamshed Ali Khan, Member Central Licensing Board.
2. Director DTL, Peshawar.
3. Syed Adnan Ali Shah, Assistant Director PE & R, Islamabad.
The constituted panel conducted detailed inspection of M/s Ferozsons Laboratories Ltd, Nowshera, Khyber
Pakhtunkhwa as per following details:
S.# Questions Observation by panel
1. Do you have documents confirming the import
of API including approval from DRAP?
Firm has documents confirming the import of 650gm of
Emagliflozin vide license No. 00335/2018-DRAP
(P)/1390 dated 13-04-2018 from manufacturer M/s.
Fuxin Long Rui Pharmaceutical Co., Ltd China.
2. What was the rationale behind selecting the
particular manufacturer of API?
The firm has informed that they have selected the said
manufacturer being GMP compliant and has provided
stability data of the said API.
3. Do you have documents confirming the import
of reference standard and impurity standards?
Firm has documents confirming the import of reference
standard (quantity: 0.05gm) and impurity standard
(quantity: 0.05gm) having invoice No.HN180508-C1.
4. Do you have certificate of Analysis of the API,
reference standards and impurity standards?
Firm has certificate of analysis of API (Batch No.E-
20180425-D01-E06-01), working standard
(Batch.No.E6DZ201801) and reference standards
(Batch.No.E5DZ201801).
5.
Do you have GMP certificate of API
manufacturer issued by regulatory authority of
country of origin?
Firm has copy of GMP certificate of API manufacturer
issued by regulatory authority of country of origin
(China).
6. Do you use API manufacturer method of testing
for testing API?
The firm has used manufacturer method of testing for
testing of API.
7. Do you have stability studies reports on API? The firm has real time and accelerated stability study
data sheets provided by the API manufacturer.
8. If yes, whether the stability testing has been
performed as per SIM method and degradation
products have been quantified?
The stability studies have been performed as per SIM
method.
9. Do you have method for quantifying the
impurities in the API?
Firm has used manufacturer’s method for quantifying
impurities in the API.
10. Do you have some remaining quantities of API,
its reference standard and impurities standards?
The firm has record of remaining quantities of impurity
standard and finished packs.
11. Have you used pharmaceutical grade excipients? All excipients used in the formulation were of
pharmaceutical grade.
12. Do you have documents confirming the import of
the used excipients?
The firm has documents confirming the purchase of
excipients used in the formulation from local supplier
and the one imported. COAs were available.
13. Do you have test reports and other records on the
excipients used?
The firm has complete testing records for the excipients
used in the formulation.
14. Do you have written and authorized protocols for
the development of applied product?
The firm has written and authorized protocols for the
development of applied product.
Minutes of 294th Meeting of Registration Board | 303
15. Have you performed Drug-excipients
compatibility studies?
The firm claimed that their formulation is in accordance
with innovator formulation so did not perform Drug-
excipients compatibility studies.
16. Have you performed comparative dissolution
studies? The firm has performed comparative dissolution studies.
17. Do you have product development (R&D)
section
The firm has dedicated product development (R&D)
section.
18.
Do you have necessary equipments available in
product development section for development
of applied product?
The firm has necessary equipment in product
development section except packaging facility as the
packaging (blistering and packing of the stability batches
have been carried out in commercial production area).
19. Are the equipments in product development
section qualified?
The equipment used in the product development section
was qualified.
20.
Do you have proper maintenance / calibration /
re-qualification program for the equipment used
in PD section?
The firm has proper maintenance and calibration for the
equipment used in product development.
21. Do you have qualified staff in product
development section with proper knowledge
and training in product development?
Firm has qualified staff with proper knowledge and
training in product development.
22.
Have you manufactured three stability batches
for the stability studies of applied product as
required?
The firm has manufactured three stability batches for the
stability studies for both strength 10mg and 25mg tablets
as per following batch details:
1) Empari tablets 10mg batch No.
a) EGTab-001
b) EGTab-002
c) EGTab-003
2) Empari tablets 25mg batch No.
a) EGTab-004
b) EGTab-005
c) EGTab-006
23. Do you have any criteria for fixing the batch
size of stability batches?
Firm has informed that a criterion for fixing batch size
was based on their minimum requirements for stability
samples used in stability studies.
24. Do you have complete record of production of
stability batches?
The firm has complete batch manufacturing record of all
the stability batches.
25. Do you have protocols for stability testing of
stability batches?
Firm has protocols for stability testing of the stability
batches.
26. Do you have developed and validated the
method for testing of stability batches?
The firm has developed and validated the method for the
testing of stability batches.
27. Do you have method transfer studies in case
when the method of testing being used by your
firm is given by any other lab?
Not Applicable
28. Do you have documents confirming the
qualification of equipments / instruments being
used in the test and analysis of API and the
finished drug?
Firm has all relevant documents confirming the
qualification of equipments/instruments used in the test
and analysis of API and the finished drug.
29. Is your method of analysis stability indicating? The method of analysis used for analysis of stability
batches was stability indicating.
30. Is your HPLC software is 21CFR compliant? The HPLC software is 21CFR compliant.
31. Can you show Audit Trail reports on stability
studies testing?
Firm has demonstrated audit trail reports of testing.
Minutes of 294th Meeting of Registration Board | 304
Furthermore, regarding the additional points identified as per DRAP letter No. F.13-11/2017-PEC(Pt) date 19th
august 2019, the details are as under:
1. Firm has performed and already submitted report of content uniformity testing (as per USP general
chapter <905>. The same is verified by the inspection panel on date of inspection.
2. Firm informed that the gap between date of manufacturing and date of initiation of stability data is due to
Eid holidays. Furthermore, the firm ensured that the batches were kept under control conditions during
that time.
Conclusion:
On risk-based approach the genuineness / authenticity of stability data submitted by the firm for registration of
Empagen 10mg and 25mg Tablet (Empagliflozin) is verifiable to satisfactory level.
Previous Decision: Registration Board decided to defer the cases, (Empagen 10mg and 25mg Tablets) and
directed the firm to submit dissolution testing data with specifications of “NLT Q within 15 minutes” at initial
and one month time point at both accelerated and real time stability conditions for 2 batches
(M-293).
Evaluation by PEC: The firm has submitted following:
01) Stability study data of initial and one month testing, 02) Raw data sheets, 03) Dissolution testing
chromatograms of following 2 batches of each strength.
a) Empagen 10mg Tablet (Empagliflozin) Batch # EGTab-001
b) Empagen 10mg Tablet (Empagliflozin) Batch # EGTab-002
c) Empagen 25mg Tablet (Empagliflozin) Batch # EGTab-004
d) Empagen 25mg Tablet (Empagliflozin) Batch # EGTab-005
32. Do you have some remaining quantities of
degradation products and stability batches?
The firm has some remaining quantities of stability
batches.
33. Do you have stability batches kept on stability
testing?
The firm has remaining quantities of stability batches
kept on stability testing.
34. Do you have valid calibration status for the
equipments used in production and analysis?
The firm has valid calibration status of the equipment
used in production and analysis.
35. Do proper and continuous monitoring and
control are available for stability chamber?
The firm has stability chambers for carrying out
accelerated and real time stability studies provided with
uninterrupted power supply and data loggers.
36.
Do related manufacturing area, equipment,
personnel & utilities be rated as GMP
compliant?
Related manufacturing area, equipment, personnel and
utilities in R&D section are as per GMP compliance.
Decision: Registration Board decided to approve registration of Empagen 10mg Tablet &
Empagen 25mg Tablet with Innovator’s specifications by M/s Ferozsons Laboratories Nowshera.
Manufacturer will place first three production batches on long term stability studies throughout
proposed shelf life and on accelerated studies for six months.
d. Exemption from onsite verification of stability data
Sr.
No.
Name &
Address of
Manufacturer /
Applicant
Brand Name
(Proprietary Name +
Dosage Form + Strength),
Composition,
Pharmacological Group,
Finished Product
Specification
Type of Form,
Initial Diary & Date,
Fee (including
differential fee),
Demanded Price /
Pack size
International
Availability / Local
Availability
GMP Inspection Report
Date & Remarks
Previous DRB
Decision /
Remarks
(if any)
377. M/s The Searle
Company
Limited, F-319,
S.I.T.E.,
Karachi
OMARIN 12.5mg Tablet
Each Film coated tablet
contains:
Omarigliptin…12.5mg
Anti-diabetic
In-house specifications
Form 5D
Dy. No.Duplicate
dated
27-03-2017
Rs. 50,000/- dated
27-03-2017,
As per SRO
Marizeb Tablet by
MSD
(PMDA Japan
Approved)
The firm was inspected
on 27.06.2018, wherein
the GMP of firm was
rated good.
Minutes of 294th Meeting of Registration Board | 305
STABILITY STUDY DATA
Drug OMARIN 12.5mg Tablet
Name of Manufacturer M/s The Searle Company Limited, F-319, S.I.T.E., Karachi
Manufacturer of API M/s RUYUAN HEC PHARM Co., LTD, Xiaba Development Zone, Ruyuan County,
Shaoguan City, Guangdong Province, PR, China
API Lot No. OMLT-RD201803002
Description of Pack
(Container closure system)
Alu Alu Blisters in unit carton
Stability Storage Condition Accelerated: 40°C ± 2°C & 75±5%RH
Real Time: 30°C ± 2°C & 65±5%RH
Time Period Accelerated: 06 Months
Real Time: 06 Months
Frequency Accelerated: 0,3,6 (Months)
Real Time: 0,3,6 (Month)
Batch No. 18PD-301 18PD-308 18PD-309
Batch Size 2500 Tablets 2500 Tablets 2500 Tablets
Manufacturing Date Dec-2018 Dec-2018 Dec-2018
Date of Initiation Jan-2019 Jan-2019 Jan-2019
No. of Batches 03
Date of Submission 04-11-2019 (Dy. No.22627)
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr.# Documents To Be Provided Status
1. COA of API Copy of COA of API (batch # OMLT-RD201803002)
from M/s RUYUAN HEC PHARM Co., LTD, China
has been submitted.
2. Approval of API by regulatory authority of country
of origin or GMP certificate of API manufacturer
issued by regulatory authority of country of origin.
The firm has submitted copy of GMP certificate issued
by Shaoguan Food and Drug Administration. It is valid
till 04-12-2021.
3. Protocols followed for conduction of stability study
and details of tests.
Yes
4. Data of 03 batches will be supported by attested
respective documents like chromatograms,
laboratory reports, data sheets etc.
Yes
5. Documents confirming import of API etc. The firm has submitted copy of commercial invoice for
the purchase of Omarigliptin (0.4Kg) attested by
Assistant Director (I & E) DRAP Karachi dated 01-08-
2018.
6. All provided documents will be attested (name, sign
& stamp) for ensuring authenticity of
data/documents.
Yes
7. Commitment to continue real time stability study till
assigned shelf life of the product.
Yes
8. Commitment to follow Drug Specification Rules,
1978.
Yes
PREVIOUS REMARKS OF EVALUATOR1
Minutes of 294th Meeting of Registration Board | 306
REQUEST OF EXEMPTION FROM ON SITE INSPECTION
The firm has requested for Exemption from On-site Investigation of their submitted stability data and provided the
following documents in conjunction with the checklist approved by the Registration Board in its 278th Meeting:
Date of submission: 04-11-2019 (Dy. No.22627)
Administrative Portion
1. Reference of last onsite panel
inspection for instant dosage form
conducted during last two years.
Firm has referred to last onsite inspection report of their product
“Ticor 60mg & 90mg Tablets”, which was presented in 293rd meeting
of Registration board. Registration Board decided to approve
registration of above stated drug product of M/s The Searle company
Ltd., Karachi.
Date of inspection: 11th March-2019
According to inspection report, following points were confirmed.
The HPLC software of the firm is 21 CRF compliant.
The firm has installed software for adequate monitoring and
control of temperature / humidity of the chamber.
2. Documents for the procurement of API
with approval from DRAP (in case of
import).
The firm has submitted copy of commercial invoice for the purchase
of Omarigliptin (0.4Kg) attested by ADC, DRAP Karachi dated 01-
08-2018.
3. Documents for the procurement of
reference standard and impurity
standards.
Evidence of procurement of reference standards is required.
4. Approval of API/ DML/GMP
certificate of API manufacturer issued
by regulatory authority of country of
origin.
The firm has submitted copy of GMP certificate issued by Shaoguan
Food and Drug Administration. It is valid till 04-12-2021.
5. Mechanism for Vendor pre-
qualification
The firm has submitted SOP for Evaluation of Vendors.
6. Certificate of analysis of the API,
reference standards and impurity
standards
Copy of COA of API (batch # OMLT-RD201803002) from M/s
RUYUAN HEC PHARM Co., LTD, China has been submitted.
Copy of COA of working standard (batch # OMLT-
RD0180101A) from API supplier has been submitted.
7. Documents for the procurement of
excipients used in product
development?
The firm has submitted documents for the procurement of excipients
used in product development
8. List of qualified staff involved in
product development with relevant
experience.
The firm has submitted List of qualified staff involved in R&D
department.
Production Data
9. Authorized Protocols/SOP for the
development & stability testing of trial
batches.
The firm has submitted copy of “Protocols/SOP for the Development
of trial batches”.
10. Complete batch manufacturing record
of three stability batches.
The firm has submitted copy of Manufacturing protocols of
following 03 Batches:
Batch No. Batch Size Mfg. Date
18PD-301 2500 Tablets Dec-2018
18PD-308 2500 Tablets Dec-2018
18PD-309 2500 Tablets Dec-2018
11. Record of remaining quantities of
stability batches.
Minutes of 294th Meeting of Registration Board | 307
Trial No Batch Size Tablets used for
stability testing
Remaining
Quantities of
tablets
18PD-301 2500 Tabs 795 Tab 30 Blisters
18PD-308 2500 Tabs 795 Tab 30 Blisters
18PD-309 2500 Tabs 795 Tab 30 Blisters
QA / QC DATA
12. Record of Digital data logger for
temperature and humidity monitoring
of stability chambers (real time and
accelerated)
Firm has submitted photocopies of data logger record for chambers
used in Real Time & Accelerated stability studies of applied product.
13. Method used for analysis of API along
with COA.
The firm has submitted copy of Raw Material Specifications, Raw
Material Testing Procedures along with COAs for Omarigliptin.
14. Method used for analysis of FPP &
complete record of testing of stability
batches (i.e. chromatograms, lab
reports, raw data sheets etc.)
The firm has submitted copy of Finished Product Testing Procedure
for “Omarin 25mg Tablet” along with Stability Study Reports.
15. Reports of stability studies of API
from manufacturer.
The firm has submitted 6 months accelerated and 24 months real time
stability study data of three batches conducted as per Zone IV-A.
16. Analysis reports for excipients used. The firm has submitted analytical reports of excipients used.
17. Drug-excipients compatibility studies. The firm has submitted that they have used same formulation as that
of innovator.
18. Record of comparative dissolution
data.
The firm has not performed comparative dissolution studies of test
formulation with reference formulation. Only dissolution studies of
test formulation in three recommended mediums at pH 1.2, pH 4.5,
pH 6.8 were performed.
19. Compliance Record of HPLC software
21CFR & audit trail reports on product
testing.
The firm has submitted audit trail reports of applied product.
The firm has submitted 6 months accelerated and 6 months real time stability studies data of 3 batches.
Observations Response of the applicant
Evidence of procurement of reference standards is
required.
The firm has submitted that we received reference
standard from API supplier through DHL.
Comparative dissolution studies do not contain
dissolution studies of reference product in three
mediums.
The firm has submitted that innovator pack was not
available therefore we only performed dissolution
studies of test formulation in three recommended
mediums i.e. 0.1 N HCl pH 1.2, buffer pH 4.5 and
phosphate buffer pH 6.8.
Decision: Registration Board decided to approve registration of OMARIN 12.5mg Tablet with
Innovator’s specifications by M/s The Searle Company Limited, F-319, S.I.T.E., Karachi.
Manufacturer will place first three production batches on long term stability studies throughout
proposed shelf life and on accelerated studies for six months.
Sr.
No.
Name &
Address of
Manufacturer /
Applicant
Brand Name
(Proprietary Name +
Dosage Form +
Strength), Composition,
Pharmacological Group,
Finished Product
Specification
Type of Form,
Initial Diary & Date,
Fee (including
differential fee),
Demanded Price /
Pack size
International
Availability / Local
Availability
GMP Inspection Report
Date & Remarks
Previous DRB
Decision /
Remarks
(if any)
378. M/s The Searle
Company
OMARIN 25mg Tablet
Form 5D Marizeb Tablet by
MSD
Minutes of 294th Meeting of Registration Board | 308
Limited, F-319,
S.I.T.E.,
Karachi
Each Film coated tablet
contains:
Omarigliptin…25mg
Anti-diabetic
In-house specifications
Dy. No.Duplicate
dated
27-03-2017
Rs. 50,000/- dated
27-03-2017,
As per SRO
(PMDA Japan
Approved)
Firm has submitted
copy of GMP
inspection report
conducted on 13-02-18.
STABILITY STUDY DATA
Drug OMARIN 25mg Tablet
Name of Manufacturer M/s The Searle Company Limited, F-319, S.I.T.E., Karachi
Manufacturer of API M/s RUYUAN HEC PHARM Co., LTD, Xiaba Development Zone, Ruyuan County,
Shaoguan City, Guangdong Province, PR, China
API Lot No. OMLT-RD201803002
Description of Pack
(Container closure system)
Alu Alu Blisters in unit carton
Stability Storage Condition Accelerated: 40°C ± 2°C & 75±5%RH
Real Time: 30°C ± 2°C & 65±5%RH
Time Period Accelerated: 06 Months
Real Time: 06 Months
Frequency Accelerated: 0,3,6 (Months)
Real Time: 0,3,6 (Month)
Batch No. 19PD-035 19PD-040 19PD-041
Batch Size 2000 Tablets 2000 Tablets 2000 Tablets
Manufacturing Date Jan-2018 Feb-2019 Feb-2019
Date of Initiation Feb-2019 Feb-2019 Feb-2019
No. of Batches 03
Date of Submission 04-11-2019 (Dy. No.22627)
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr.# Documents To Be Provided Status
1. COA of API Copy of COA of API (batch # OMLT-RD201803002)
from M/s RUYUAN HEC PHARM Co., LTD, China
has been submitted.
2. Approval of API by regulatory authority of country
of origin or GMP certificate of API manufacturer
issued by regulatory authority of country of origin.
The firm has submitted copy of GMP certificate issued
by Shaoguan Food and Drug Administration. It is valid
till 04-12-2021.
3. Protocols followed for conduction of stability study
and details of tests.
Yes
4. Data of 03 batches will be supported by attested
respective documents like chromatograms,
laboratory reports, data sheets etc.
Yes
5. Documents confirming import of API etc. The firm has submitted copy of commercial invoice for
the purchase of Omarigliptin (0.4Kg) attested by ADC,
DRAP Karachi dated 01-08-2018.
6. All provided documents will be attested (name, sign
and stamp) for ensuring authenticity of data /
documents.
Yes
Minutes of 294th Meeting of Registration Board | 309
7. Commitment to continue real time stability study till
assigned shelf life of the product.
Yes
8. Commitment to follow Drug Specification Rules,
1978.
Yes
PREVIOUS REMARKS OF EVALUATOR1
REQUEST OF EXEMPTION FROM ON SITE INSPECTION
The firm has requested for Exemption from On-site Investigation of their submitted stability data and provided the
following documents in conjunction with the checklist approved by the Registration Board in its 278th Meeting:
Date of submission: 04-11-2019 (Dy. No.22627)
Administrative Portion
1. Reference of last onsite panel
inspection for instant dosage form
conducted during last two years.
Firm has referred to last onsite inspection report of their product
“Ticor 60mg & 90mg Tablets”, which was presented in 293rd meeting
of Registration board. Registration Board decided to approve
registration of above stated drug product of M/s The Searle company
Ltd., Karachi.
Date of inspection: 11th March-2019
According to inspection report, following points were confirmed.
The HPLC software of the firm is 21 CRF compliant.
The firm has installed software for adequate monitoring and
control of temperature / humidity of the chamber.
2. Documents for the procurement of API
with approval from DRAP (in case of
import).
The firm has submitted copy of commercial invoice for the purchase
of Omarigliptin (0.4Kg) attested by ADC, DRAP Karachi dated 01-
08-2018.
3. Documents for the procurement of
reference standard and impurity
standards.
Evidence of procurement of reference standards is required.
4. Approval of API/ DML/GMP
certificate of API manufacturer issued
by regulatory authority of country of
origin.
The firm has submitted copy of GMP certificate issued by Shaoguan
Food and Drug Administration. It is valid till 04-12-2021.
5. Mechanism for Vendor pre-
qualification
The firm has submitted SOP for Evaluation of Vendors.
6. Certificate of analysis of the API,
reference standards and impurity
standards
Copy of COA of API (batch # OMLT-RD201803002) from M/s
RUYUAN HEC PHARM Co., LTD, China has been submitted.
Copy of COA of working standard (batch # DWS20170801) from
API supplier has been submitted.
7. Documents for the procurement of
excipients used in product
development?
The firm has submitted documents for the procurement of excipients
used in product development
8. List of qualified staff involved in
product development with relevant
experience.
The firm has submitted List of qualified staff involved in R&D
department.
Production Data
9. Authorized Protocols/SOP for the
development & stability testing of trial
batches.
The firm has submitted copy of “Protocols/SOP for the Development
of trial batches”.
10. Complete batch manufacturing record
of three stability batches.
The firm has submitted copy of Manufacturing protocols of
following 03 Batches:
Batch No. Batch Size Mfg. Date
Minutes of 294th Meeting of Registration Board | 310
19PD-035 2000 Tablets Jan-2019
19PD-040 2000 Tablets Feb-2019
19PD-041 2000 Tablets Feb-2019
11. Record of remaining quantities of
stability batches.
Trial No Batch Size Tablets used
for stability
testing
Remaining
Quantities of
tablets
19PD-035 2000 Tab 795 Tab 30 Blisters
19PD-040 2000 Tab 795 Tab 30 Blisters
19PD-041 2000 Tab 795 Tab 30 Blisters
QA / QC DATA
12. Record of Digital data logger for
temperature and humidity monitoring
of stability chambers (real time and
accelerated)
Firm has submitted photocopies of data logger record for chambers
used in Real Time & Accelerated stability studies of applied product.
13. Method used for analysis of API along
with COA.
The firm has submitted copy of Raw Material Specifications, Raw
Material Testing Procedures along with COAs for Omarigliptin.
14. Method used for analysis of FPP &
complete record of testing of stability
batches (i.e. chromatograms, lab
reports, raw data sheets etc.)
The firm has submitted copy of Finished Product Testing Procedure
for “Omarin 25mg Tablet” along with Stability Study Reports.
15. Reports of stability studies of API
from manufacturer.
The firm has submitted 6 months accelerated and 24 months real time
stability study data of three batches conducted as per Zone IV-A.
16. Analysis reports for excipients used. The firm has submitted analytical reports of excipients used.
17. Drug-excipients compatibility studies. The firm has submitted that they have used same formulation as that
of innovator.
18. Record of comparative dissolution
data.
The firm has not performed comparative dissolution studies of test
formulation with reference formulation. Only dissolution studies of
test formulation in three recommended mediums at pH 1.2, pH 4.5,
pH 6.8 were performed.
19. Compliance Record of HPLC software
21CFR & audit trail reports on product
testing.
The firm has submitted audit trail reports of applied product.
The firm has submitted 6 months accelerated and 6 months real time stability studies data of 3 batches.
Observations Response of the applicant
Evidence of procurement of reference standards is
required.
The firm has submitted that we received reference
standard from API supplier through DHL.
Comparative dissolution studies do not contain
dissolution studies of reference product in three
mediums.
The firm has submitted that innovator pack was not
available therefore we only performed dissolution
studies of test formulation in three recommended
mediums i.e. 0.1 N HCl pH 1.2, buffer pH 4.5 and
phosphate buffer pH 6.8.
Decision: Registration Board decided to approve registration of OMARIN 25mg Tablet with
Innovator’s specifications by M/s The Searle Company Limited, F-319, S.I.T.E., Karachi.
Manufacturer will place first three production batches on long term stability studies throughout
proposed shelf life and on accelerated studies for six months.
Minutes of 294th Meeting of Registration Board | 311
Sr.
No.
Name & Address of
Manufacturer /
Applicant
Brand Name
(Proprietary Name +
Dosage Form +
Strength), Composition,
Pharmacological Group,
Finished Product
Specification
Type of Form,
Initial Diary &
Date, Fee
(including
differential fee),
Demanded Price /
Pack size
International
Availability /
Local Availability
GMP Inspection
Report Date &
Remarks
Previous DRB
Decision / Remarks
(if any)
379. M/s Pharmatec
Pakistan (Pvt.)
Limited, D-86/A,
S.I.T.E., Karachi
DAPAZIN 10mg Tablet
Each Film coated tablet
contains:
Dapagliflozin
propanediol
monohydrate eq. to
dapagliflozin….10mg
Selective sodium
glucose co-transporter
subtype-2 (SGLT2)
Inhibitor
In-house specifications
Form 5
Dy. No.37918
dated
16-11-2018
Rs. 20,000/-
dated
26-11-2018,
7’s, 14’s, 28’s,
30’s & 100’s; As
per SRO
Farxiga tablet
10mg (USFDA
approved)
Firm has
submitted copy of
GMP inspection
report
conducted on 30-
04-18 concluding
Good GMP
compliance.
STABILITY STUDY DATA
Drug DAPAZIN 10MG TABLET
Name of Manufacturer M/s Pharmatec Pakistan (Pvt.) Limited, D-86/A, S.I.T.E., Karachi
Manufacturer of API M/s Shanghai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd
Address: Daixi Street, Luoyang Town, Wujin District, Changzhou, Jiangsu, China.
API Lot No. DGF20180501
Description of Pack
(Container closure system)
Alu Alu Blister
Stability Storage Condition Accelerated: 40°C ± 2°C & 75±5%RH
Real Time: 30°C ± 2°C & 65±5%RH
Time Period Accelerated: 06 Months
Real Time: 06 Months
Frequency Accelerated: 0,3,6 (Months)
Real Time: 0,3,6 (Month)
Batch No. 18PD084DAPT04 18PD075DAPT02 18PD082DAPT03
Batch Size 2500 Tablets 2500 Tablets 1800 Tablets
Manufacturing Date Aug-2018 July-2018 Aug-2018
Date of Initiation 14-09-2018 27-08-2018 01-09-2018
No. of Batches 03
Date of Submission 25-01-2019 (Dy. No. 3453)
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr.# Documents To Be Provided Status
1. COA of API Copy of COA of API (batch # DGF20180501) from
M/s Shanghai Pharma Group Changzhou Kony
Pharmaceutical Co., Ltd, China has been submitted.
2. Approval of API by regulatory authority of country
of origin or GMP certificate of API manufacturer
issued by regulatory authority of country of origin.
The firm has submitted copy of GMP certificate
declaring that M/s Shanghai Pharma Group
Changzhou Kony Pharmaceutical Co., Ltd, China is
Minutes of 294th Meeting of Registration Board | 312
following Good Manufacturing Practices. The
certificate is issued by Jiangsu Food and Drug
Administration. It is valid till 01-12-2018.
3. Protocols followed for conduction of stability study
and details of tests.
Yes
4. Data of 03 batches will be supported by attested
respective documents like chromatograms,
laboratory reports, data sheets etc.
Yes
5. Documents confirming import of API etc. The firm has submitted copy of commercial invoice for
the purchase of Dapagliflozin (1.5Kg) attested by
ADC, DRAP Karachi dated 21-06-2018.
6. All provided documents will be attested (name, sign
and stamp) for ensuring authenticity of data /
documents.
Yes
7. Commitment to continue real time stability study till
assigned shelf life of the product.
Yes
8. Commitment to follow Drug Specification Rules,
1978.
Yes
PREVIOUS REMARKS OF EVALUATOR1
REQUEST OF EXEMPTION FROM ON SITE INSPECTION
The firm has requested for Exemption from On-site Investigation of their submitted stability data and provided the
following documents in conjunction with the checklist approved by the Registration Board in its 278th Meeting:
Date of submission: 14-10-2019 (Dy. No. 20505)
Administrative Portion
1. Reference of last onsite panel
inspection for instant dosage form
conducted during last two years.
Firm has referred to onsite inspection report of their product “Apixa
2.5mg & 5mg Tablets”, which was presented in 289th meeting of
Registration board. Registration Board decided to approve
registration of above stated drug product of M/s Pharmatec Pakistan
(pvt) Ltd, Islamabad
Date of inspection: 30th April-2019
According to inspection report, following points were confirmed.
The HPLC software of the firm is 21 CRF compliant.
The firm has installed software for adequate monitoring and
control of temperature / humidity of the chamber.
2. Documents for the procurement of API
with approval from DRAP (in case of
import).
The firm has submitted copy of commercial invoice for the purchase
of Dapagliflozin propanediol monohydrate (1.5Kg) attested by ADC,
DRAP Karachi dated 21-06-2018.
3. Documents for the procurement of
reference standard & impurity
standards.
Copy of invoice for the purchase of Dapagliflozin propanediol
monohydrate WS from API supplier is submitted.
4. Approval of API/ DML/GMP
certificate of API manufacturer issued
by regulatory authority of country of
origin.
The firm has submitted copy of GMP certificate declaring that M/s
Shanghai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd,
China is following Good Manufacturing Practices. The certificate is
issued by Jiangsu Food and Drug Administration. It is valid till 01-
12-2018.
5. Mechanism for Vendor pre-
qualification
The firm has submitted SOP for Evaluation of Vendors.
Minutes of 294th Meeting of Registration Board | 313
6. Certificate of analysis of the API,
reference standards and impurity
standards
Copy of COA of API (batch # DGF20180501) from M/s
Shanghai Pharma Group Changzhou Kony Pharmaceutical Co.,
Ltd, China has been submitted.
Copy of COA of working standard (batch # DWS20170801) from
API supplier has been submitted.
7. Documents for the procurement of
excipients used in product
development?
The firm has submitted documents for the procurement of excipients
used in product development
8. List of qualified staff involved in
product development with relevant
experience.
The firm has submitted List of qualified staff involved in R&D
department.
Production Data
9. Authorized Protocols/SOP for the
development & stability testing of trial
batches.
The firm has submitted copy of “Protocols/SOP for the Development
of trial batches”.
10. Complete batch manufacturing record
of three stability batches.
The firm has submitted copy of Manufacturing protocols of
following 03 Batches: Batch No. Batch Size Mfg. Date
18PD075DAPT02 1800 Tablets July-2018
18PD082DAPT03 2500 Tablets Aug-2018
18PD084DAPT04 2500 Tablets Aug-2018
11. Record of remaining quantities of
stability batches.
Trial No Batch Size Tablets used for
stability testing
Remaining
Quantities of
tablets
18PD075D
APT02 1800 Tab 795 Tab 46 Blisters
18PD082D
APT03 2500 Tab 795 Tab 60 Blisters
18PD084D
APT04 2500 Tab 795 Tab 40 Blisters
QA / QC DATA
12. Record of Digital data logger for
temperature and humidity monitoring
of stability chambers (real time and
accelerated)
Firm has submitted photocopies of data logger record for chambers
used in Real Time & Accelerated stability studies of applied product.
13. Method used for analysis of API along
with COA.
The firm has submitted copy of Raw Material Specifications, Raw
Material Testing Procedures along with COAs for Dapagliflozin
Propanediol monohydrate.
14. Method used for analysis of FPP &
complete record of testing of stability
batches (i.e. chromatograms, lab
reports, raw data sheets etc.)
The firm has submitted copy of Finished Product Testing Procedure
for “Dapagliflozin 10mg tablet” along with Stability Study Reports.
15. Reports of stability studies of API
from manufacturer.
The firm has submitted 6 months accelerated and 24 months real time
stability study data of three batches. However, storage conditions for
real time stability studies mentioned are 25oC ± 2 oC/ 65% ± 5%.
16. Analysis reports for excipients used. The firm has submitted analytical reports of excipients used.
17. Drug-excipients compatibility studies. No physical and chemical incompatibilities were found on the basis
of various literatures.
18. Record of comparative dissolution
data.
The firm has performed comparative dissolution for “Forxiga 10mg
Tablet (batch#AAS6462) of AstraZeneca” & Dapagliflozin 10mg
Minutes of 294th Meeting of Registration Board | 314
Tablet” in three recommended mediums at pH 1.2, pH 4.5, pH 6.8.
Dissolution profiles of both products were considered similar.
If the reference and test products show more than 85% dissolution
within 15 min, the profile is considered similar, no calculation of f2
factor is required.
19. Compliance Record of HPLC software
21CFR & audit trail reports on product
testing.
The firm has submitted audit trail reports of applied product.
The firm has submitted 6 months accelerated and 6 months real time stability studies data of 3 batches.
Observations Response of the applicant
Though GMP certificate of API manufacturer was
valid at the time of Assistant Director (I & E) DRAP
clearance, however, it is expired now. Therefore, you
may submit updated copy of GMP certificate of API
manufacturer.
Submitted.
Justify the dissolution acceptance criteria of value of
Q = 80% in 30 min while the innovator product
(Farxiga) has specified the dissolution specifications
of NLT 85% in 15 min.
We have followed FDA dissolution method.
Dissolution time 30 min is mentioned in FDA method.
Complete batch manufacturing record of three
stability batches is required to be submitted.
Submitted.
Drug excipient compatibility studies are required if
formulation is not as per innovator.
The firm has submitted Drug-excipient compatibility
studies assessed by HPLC binary mixtures.
Decision: Registration Board decided to defer the case of DAPAZIN 10mg Tablet and directed the
firm to submit dissolution testing data with specifications of “NLT Q within 15 minutes” at initial
and one month time point at both accelerated and real time stability conditions for 2 batches.
Deferred cases: 380. Name and address of manufacturer /
Applicant
M/s Wilson’s pharmaceuticals, 387-388, Industrial Area,
Islamabad.
Brand Name +Dosage Form + Strength Sofvasc Trio Tablets 40/5/12.5mg
Composition Each film coated tablet contains:
Olmesartan Medoxomil……..40mg
Amlodipine as besylate…..…5mg
Hydrochlorothiazide ..............12.5mg
Diary No. Date of R& I & fee Dy No.338 (11-12-2010/) Rs. 60,000 17-05-2013/
Pharmacological Group Antihypertensive agent, Diuretic
Type of Form Form-5D
Finished product Specification Manufacturer’s Specifications
Pack size & Demanded Price 10’s, 20’s, 30’s ; Rs. 502 per tablet
Approval status of product in Reference
Regulatory Authorities.
Approved in US-FDA
(Tribenzor tablets of Daiichi Sankyo, Germany)
Me-too status
GMP status GMP Inspection conducted on 24-01-2018 with conclusive
remarks that firm is operating at satisfactory level of GMP
compliance.
STABILITY STUDY DATA
Drug Sofvasc Trio Tablets 40/5/12.5mg
Name of Manufacturer M/s Wilson’s pharmaceuticals, 387-388, Industrial Area, Islamabad.
Manufacturer of API M/s Glenmark Pharmaceuticals Ltd ,Maharashtra, India(Olmesartan Medoxomil)
M/s Hetero Drugs Ltd (UNIT-IV) , Telangana, India(Amlodipine Besylate)
M/s Suzhou Lixin Pharmaceuticals Co.Ltd ,China(Hydrochlorothiazide)
Minutes of 294th Meeting of Registration Board | 315
API Lot No. Lot #:83170554 (Olmesartan Medoxomil)
Lot #:AM0331216 (Amlodipine Besylate)
Lot #:C01-20170102 (Hydrochlorothiazide)
Description of Pack
(Container closure system)
Alu /Alu Blister Pack in Unit carton
Stability Storage Condition Accelerated:40°C ± 2°C/75%±5% RH
Real Time: 30°C ± 2°C/65%±5% RH
Time Period Accelerated: 6 (Months)
Real Time: 6 (Months)
Frequency Accelerated: 0,1,2,3,4,6 (Months)
Real Time: 0,3,6,9,12,18,24 (Months)
Batch No. Trial #01 Trial #02 Trial #03
Batch Size 1500 tablets 1500 tablets 1500 tablets
Manufacturing Date 02-2018 02-2018 02-2018
Date of Initiation 22-02-2018 22-02-2018 22-02-2018
No. of Batches 03
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr.
No.
Documents To Be Provided Status
1. COA of API. Copy of COA (batch #83170554) from M/s
Glenmark Pharmaceuticals Ltd, Maharashtra, India
(Olmesartan Medoxomil)
Copy of COA (batch # AM0331216) from M/s
Hetero Drugs Ltd(UNIT-IV), Telangana, India
(Amlodipine Besylate)
Copy of COA (batch # C01-20170102) from M/s
Suzhou Lixin Pharmaceuticals Co.Ltd, China
(Hydrochlorothiazide)
2. Approval of API by regulatory authority of country
of origin or GMP certificate of API manufacturer
issued by regulatory authority of country of origin.
Copy of GMP certificate (certificate No. 1708289)
issued by Food & Drugs Administration, India. It is
valid until 18-8-2019(Olmesartan Medoxomil)
Copy of GMP certificate (certificate No.1438/E
(G)/TS/2018) issued by Drugs Control
Administration, Telagana, India. It is valid until 04-
04-2019 (Amlodipine Besylate)
Copy of GMP certificate (certificate
No.JS20140325) issued by Food & Drug
Administration, China. It is valid until 25-8-
2019(Hydrochlorothiazide)
3. Protocols followed for conduction of stability study
and details of tests.
Yes
4. Data of 03 batches will be supported by attested
respective documents like chromatograms,
laboratory reports, data sheets etc.
Yes
5. Documents confirming import of API etc. Firm has submitted copy of commercial invoice dated
18-09-2017(Olmesartan Medoxomil) attested by
ADC, DRAP, Islamabad
Minutes of 294th Meeting of Registration Board | 316
Firm has submitted copy of commercial invoice dated
19-12-2016(Amlodipine Besylate) attested by ADC,
DRAP, Islamabad
Firm has submitted copy of commercial invoice dated
09-03-2017(Hydrochlorothiazide) attested by ADC,
DRAP, Islamabad
6. All provided documents will be attested (name, sign
and stamp) for ensuring authenticity of data /
documents.
Yes
7. Commitment to continue real time stability study
till assigned shelf life of the product.
Yes
8. Commitment to follow Drug Specification Rules,
1978.
Yes
REMARKS OF EVALUATOR
● The firm has submitted 6months Accelerated and Real Time Stability Data for 03 Batches.
REQUEST OF EXEMPTION FROM ON SITE INSPECTION
The firm has requested for Exemption from On-site Investigation of their submitted stability data and provided the
following documents in conjunction with the checklist approved by the Registration Board in its 278th Meeting:
Administrative Portion
1. Reference of last onsite panel inspection
for instant dosage form conducted
during last two years.
Firm has referred to onsite inspection reports of their product
“Saferon tablets (Sofosbuvir 400 mg)”, which was presented in 278th
meeting of Registration Board held on 29-31st Jan, 2018
Observations: Software of HPLC present in the firm is 21 CFR
compliant and audit trail on the testing reports was available and
confirmed. Panel reviewed chromatograms for testing of API and
trial batches at 0, 3 and 6 months for real time and accelerated
stability testing.
Decision: Registration Board decided to approve registration of
“Saferon (Sofosbuvir 400mg)” by M/s Wilson Pharmaceuticals,
Islamabad. Manufacturer will place first three production batches on
long term stability studies
2. Documents for the procurement of API
with approval from DRAP (in case of
import).
Copy of commercial invoice dated 18-09-2017 declaring 10Kgs
quantity of API (Olmesartan Medoxomil has been submitted which
is attested by ADC, DRAP, Islamabad.
Copy of commercial invoice dated 19-12-2016 declaring 300kgs
quantity of API (Amlodipine Besylate) has been submitted which is
attested by ADC, DRAP, Islamabad dated 29-12-2016.
Copy of commercial invoice dated 09-03-2017 declaring 300Kgs
quantity of API (Hydrochlorothiazide) has been submitted which is
attested by ADC, DRAP, Islamabad dated 29-3-2017.
3. Documents for the procurement of
reference standard and impurity
standards.
The firm has submitted copies of invoices for working standard &
impurity Standards regarding Amlodipine besylate, Olmesartan
Medoxomil and Hydrochlorothiazide.
4. Approval of API/ DML/GMP certificate
of API manufacturer issued by
regulatory authority of country of
origin.
The firm has submitted copy of GMP certificate declaring following
information:
Certificate No.1708289
Issued to: M/s Glenmark pharmaceuticals Ltd Plot
No3109,GIDC.Industrial estate, Ankleshwar
Issued by: Food & Drug Administration, Gandhagar Gujarat state
India.
Validity: Valid Till 18-08-2019.
Minutes of 294th Meeting of Registration Board | 317
The firm has submitted copy of GMP certificate declaring following
information:
Certificate No.1438/E(G)/TS/2018
Issued to: M/s Hetero Drugs limited Unit IV Sy.No.599,Temple
Road Bonthapally Village ,Gummadidala Mandal,Sangareddy
District,Telangana State,India
Issued by: Food & Drug Administration, Gandhagar Gujarat state
India.
Validity: Valid Till 04-04-2019.
The firm has submitted copy of GMP certificate declaring following
information:
Certificate No.JS20140325
Issued to: M/s Suzhou Lixin Pharmaceuticals Co,Ltd
No.21 Tangxi Road,Suzhou New District,Suzhou
Issued by:Food & Drug Administration,China
Validity: Valid Till 25-08-2019.
5. Mechanism for Vendor pre-
qualification
The firm has submitted SOP for Evaluation of Vendors.
6. Certificate of analysis of the API,
reference standards and impurity
standards
Applicant has submitted following COAs:
Copy of COA olmesartan Medoxomil (batch #83170554)
from M/s Glenmark Pharmaceuticals Ltd ,Maharashtra, India
Copy of COA of Amlodipine besylate (batch # AM0331216)
from M/s Hetero Drugs Ltd(UNIT-IV) ,Telangana, India
Copy of COA of Hydrochlorothiazide (batch # C01-
20170102) from M/s Suzhou Lixin Pharmaceuticals Co.Ltd,
China
Copy of COA of reference standard has been submitted
Copy of COA impurity Standards Olmesartan olefinic,
Olmesartan related compound A, Olmesartan impurity A,
Olmesartan N-Alkyl impurity has been submitted.
Copy of COA impurity Standards Hydrochorothiazide
impurity A&B has been submitted.
Copy of COA impurity Standards of Amlodipine impurity A,
Amlodipine impurity D, Amlodipine impurity E, Amlodipine
impurity F has been submitted.
7. Documents for the procurement of
excipients used in product
development?
The firm has submitted copy of purchase order/Commercial
invoices/COAs of all the excipients used in the formulation of
applied product.
8. List of qualified staff involved in
product development with relevant
experience.
The firm has submitted List of qualified staff involved in R&D
department.
Production Data
9. Authorized Protocols/SOP for the
development & stability testing of trial
batches.
The firm has submitted copy of “Protocols/SOP for the Development
of Sofvasc Trio Tablets 40/10/12.5mg”.
10. Complete batch manufacturing record
of three stability batches.
The firm has submitted copy of Batch Manufacturing Records of
following 03 Batches:
Batch No. Batch Size Mfg. Date
Trial # 01 1500 tablets 02-2018
Trial # 02 1500 tablets 02-2018
Trial # 03 1500 tablets 02-2018
Minutes of 294th Meeting of Registration Board | 318
11. Record of remaining quantities of
stability batches.
The firm has submitted reconciliation sheet mentioning following
details:
Trial No Sofvasc Trio Tablets 40/5/12.5mg
Remaining Quantity
Accelerated Long Term
Trial # 01 110 tablets 216 tablets
Trial # 02 110 tablets 234 tablets
Trial # 03 110tablets 234 tablets
QA / QC DATA
12. Record of Digital data logger for
temperature and humidity monitoring of
stability chambers (real time and
accelerated).
Firm has submitted photocopies of data logger record for chambers
used in Real Time & Accelerated stability studies of applied product
from 01-02-2018to 31-08-2018.
13. Method used for analysis of API along
with COA.
The firm has submitted photocopies of following:
Raw Material Test/Analysis Procedures & Raw Material
Specifications of Amlodipine Besylate , Hydrochlorothiazide and
Olmesartan Medoxomil (In-house+USP) & COAs for Olmesartan
Medoxomil/Amlodipine Besylate/
Hydrochorothiazide (Supplier/Manufacturer).
14. Method used for analysis of FPP &
complete record of testing of stability
batches (i.e. chromatograms, lab
reports, raw data sheets etc.)
The firm has submitted photocopies of following:
FPP Test/Analysis Method & FPP Specifications (In-house) for
Sofvasc Trio 40/10/12.5mg tablet along-with analytical record for
complete stability studies.
15 Reports of stability studies of API from
manufacturer.
The firm has submitted copy of 06 Months Accelerated and 60
Months Real Time Stability Study Data of 03 Batches of
Olmesartan Medoxomil M/s Glenmark Pharmaceuticals Ltd
,Maharashtra, India ,
Amlodipine besylate 06 Months Accelerated and 36 Months Real
Time Stability Study Data and
Hydrochorothiazide 06month accelerated and 48 Months Real
Time Stability Study M/s Suzhou Lixin Pharmaceuticals Co. Ltd
,China, as per Zone-IV a conditions.
16 Analysis reports for excipients used. The firm has submitted copy of Analytical reports of excipients used.
17 Drug-excipients compatibility studies. Firm has declared that Drug-excipient compatibility studies are
applicable since they have used similar qualitative formulation as
that of innovator’s product.
18 Record of comparative dissolution data. The firm has performed comparative dissolution studies in three
media including in 0.1NHCl, Acetate Buffer pH 4.5 and phosphate
Buffer pH 6.8 with Tribenzor Tablets 40/10/12.5mg manufactured
by M/s. Daiichi Sankyo, Germany Lot No: 0004213.
The firm‘s product results are comparable to that of the comparator
product.
19 Compliance Record of HPLC software
21CFR & audit trail reports on product
testing.
Audit trail on testing reports of applied formulation from 22-02-2018
to 22-08-2018 was submitted by the firm.
Remarks:
Valid GMP certificates of all three API manufacturers shall be submitted.
Protocol for stability testing has not been submitted.
As per submitted batch manufacturing record, all the three trial batches have been compressed using single
punch machine.
Minutes of 294th Meeting of Registration Board | 319
You have not performed uniformity of dosage unit by content uniformity for in all the strengths, as
recommended by USP General Chapter <905> throughout stability studies. Justification shall be submitted in this
regard.
Firm has performed CDP using 6 tablets each of the reference and applied product. Moreover f2 factor
calculation has not been performed, although submitted results are comparable.
Reference product literature declares the dissolution time as 30 minutes whereas firm has applied limit of
45 minutes for dissolution test.
Previous Decision: Registration Board deferred the case for justification of limits for Dissolution test in terms of
time, since reference product literature declare the dissolution time as 30 minutes whereas firm has applied limit of
45 minutes for dissolution test (M-292).
Evaluation by PEC:
The firm has submitted that it is committed to perform dissolution test of our applied formulation as per innovator’s
specification at next time points of stability data. Similarly we will perform dissolution test as per innovator on our
commercial batches.
Discussion: Registration Board deliberated on the dissolution specifications and acceptance criteria submitted by
the firm and keeping in view its decision of 293rd meeting decided to accept the dissolution specifications since it
falls under the definition of immediate release drug product.
Decision: Registration Board decided as follows:
Accept the stability study data as the dissolution specifications falls within the definition of
immediate release drug product and approved registration of Sofvasc Trio Tablets 40/5/12.5mg with
Innovator’s specifications by M/s Wilson’s Pharmaceuticals, I-9, Industrial Area Islamabad,
wherein manufacturer will adopt the dissolution specifications i.e. NLT Q at 30 minutes for
commercial production batches.
Furthermore, manufacturer will place first three production batches on long term stability
studies throughout proposed shelf life and on accelerated studies for six months.
Sr.
No
.
Name & Address
of Manufacturer /
Applicant
Brand Name
(Proprietary Name +
Dosage Form +
Strength), Composition,
Pharmacological
Group,
Finished Product
Specification
Type of Form,
Initial Diary &
Date, Fee
(including
differential fee),
Demanded Price /
Pack size
International Availability
/ Local Availability
GMP Inspection Report
Date & Remarks
Remarks
381. M/s Wilson’s
Pharmaceuticals,
I-9, Industrial
Area Islamabad.
Sofvasc Trio Tablet
40/10/12.5
Each Tablet contains:
Olmesartan medoxomil
…………….40mg
Amlodipine besylate
…………. 10mg
Hydrochlorothiazide
………… 12.5mg.
Anti-Hypertensive
agent, Diuretic
Form-5-D
10’s, 20’s&30’s
Rs.542/- Tablet
11-12-
2010/3365.
17-05-2013/3125
Rs. 60,000/-
Tribenzor
USFDA Approved
24-01-2018 Conclusion:
“Overall the firm was
found to be operating at a
very good level of CGMP
Compliance at the time of
inspection.”
Drug Sofvasc Trio Tablet 40/10/12.5
Name of Manufacturer M/s Wilson’s Pharmaceuticals,I-9, Industrial Area Islamabad.
Manufacturer of API Olmesartan medoxomil: M/s Glenmark Pharmaceuticals Ltd. India.
Amlodipine besilate: M/s Hetero Drugs Limited (Unit-IV), India.
Hydrochlorothiazide: M/s Suzhou Lixin Pharmaceutical Co.Ltd, China.
API Lot No. Olmesartan medoxomil: 83170554
Amlodipine besilate: AM0321216, AM0331216
Hydrochlorothiazide: C01-20170102
Minutes of 294th Meeting of Registration Board | 320
Description of Pack
(Container closure system) Alu-Alu strip
Stability Storage Condition Real Time: 30oC ± 2oC / 65% ± 5%RH
Accelerated:40oC ±2oC / 75% ± 5%RH
Time Period Real Time: 06 Months Accelerated: 06 Months
Frequency Real Time: 0,3,6 (Months) Accelerated: 0,1,2,3,4,6 (Months)
Batch No. Trial # 01 Trial # 02 Trial # 03
Batch Size 1500 tablets 1500 tablets 1500 tablets
Manufacturing Date 02-2018 02-2018 02-2018
Date of Initiation 02-2018 02-2018 02-2018
No. of Batches 03
Date of Submission 28-01-2019 (Dy. No. 3665)
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr.# Documents To Be Provided Status
COA of API Yes
Approval of API by regulatory authority of
country of origin or GMP certificate of API
manufacturer issued by regulatory authority of
country of origin.
M/s Glenmark Pharmaceuticals Ltd. India: copy of GMP
Certificate No. 1708289 issued by Food & Drugs Control
Administration (Gujarat) India, valid up to 18-08-2019 is
submitted.
M/s Hetero Drugs Limited (Unit-IV), India:
copy of GMP Certificate No.
1438/E(G)/TS/2018 issued by Drugs Control
Administration (Telangana) India, valid up to 04- 04-
2019 is submitted.
M/s Suzhou Lixin Pharmaceutical Co. Ltd, China: copy
of GMP Certificate No. JS20140325 issued by Jiangsu
Food and Drug Administration China, valid up to 25-08-
2019 is submitted.
Protocols followed for conduction of stability
study and details of tests.
No
Data of 03 batches will be supported by attested
respective documents like chromatograms,
laboratory reports, data sheets etc.
Yes
Documents confirming import of API etc. Yes
All provided documents will be attested (name,
sign and stamp) for ensuring authenticity of data /
documents.
Yes
Commitment to continue real time stability study
till assigned shelf life of the product.
Yes
Commitment to follow Drug Specification Rules,
1978.
Yes
REMARKS OF EVALUATOR
The firm has provided 6 months Accelerated and 6 months Real Time Stability Study Data for 03 Batches.
Dissolution parameters as submitted with Stability Study Data are as per USFDA recommended dissolution
method.
REQUEST OF EXEMPTION ROM ON SITE INSPECTION
Minutes of 294th Meeting of Registration Board | 321
Administrative Portion
1. Reference of last onsite panel inspection
for instant dosage form conducted
during last two years.
Firm has referred to onsite inspection reports of their product
“Saferon Tablets (Each film coated tablet contains:
Sofosbovir…..400mg) approved in 278th Meeting of Registration
Board.
1. Firm presented test results of trial batches conducted at various
time intervals (0, 3, 6 for both real time and accelerated stability
testing) and real time testing at 9, 12, 18 and 24 months, which
showed that trial batches were of standard quality during
aforementioned test intervals. Moreover, both chambers have
been provided with digital data loggers with record of test period
since January, 2016.
2. Software of HPLC present in the firm is 21CFR compliant and
audit trail on the testing reports was available and confirmed.
Panel reviewed chromatograms for testing of API and trial
batches at 0, 3 and 6 months for real time and accelerated
stability testing.
2. Documents for the procurement of API
with approval from DRAP (in case of
import).
HYDROCHLORTHIAZIDE
Details of Assistant Director (I & E) DRAP attested
commercial Invoice Invoice No. SZLX2017019A
Quantity imported: 300 Kg
Assistant Director (I & E) DRAP Attestation Date: 29-03-2017
Manufacturer: Suzhou Lixin Pharmaceutical Co. Ltd., No 21, Tangxi
Road, Suzhou, New District, China
Batch No.: C01-20170102
DOM: 19-12-2016
AMLODIPINE BESYLATE
Details of Assistant Director (I & E) DRAP attested
commercial Invoice Invoice No. 1000023678
Quantity imported: 300 Kg
Assistant Director (I & E) DRAP Attestation Date: 29-12-2016
Manufacturer: Hetero Drugs Limited,7-2-A2, Hetero Corporate,
Industrial Estate, Sanath Nagar, Hyderabad, Telangana, India
Batch No.: AM0321216, AM0331216
DOM: 12-2016,
OLMESARTAN MEDOXOMIL
Details of Assistant Director (I & E) DRAP attested
commercial Invoice Invoice No. 2007601342
Quantity imported: 10 Kg
Assistant Director (I & E) DRAP Attestation Date: 16-10-2017
Manufacturer: M/s Glenmark Pharmaceuticals Ltd., Plot No. A-80,
MIDC, Kurkumbh, Taluka-Daund, District- Pune, India.
Batch No.: 83170554
DOM: 03-09-2017,
3. Documents for the procurement of
reference standard and impurity
standards.
HYDROCHLORTHIAZIDE
Working Standard
1g from 3J Diagnostic, TRC Canada
Impurities
Impurity A (Suzhou Lixin Pharmaceutical Co. Ltd)
Impurity B (Suzhou Lixin Pharmaceutical Co. Ltd)
Chlorthiazide
Benzothiadiazine Related Compound A
Minutes of 294th Meeting of Registration Board | 322
AMLODIPINE BESYLATE WORKING STANDARD
Working Standard
25g from 3J Diagnostic, , TRC Canada
OLMESARTAN MEDOXOMIL WORKING STANDARD
Working Standard
1g from 3J Diagnostic, , TRC Canada
Olmesartan Impurity A (Synpure Labs)
Olmesartan Olefenic Impurity (Synpure Labs)
Olmesartan Related Compound A(Synpure Labs)
Omlesartan Alkyl Impurity(Synpure Labs)
4. Approval of API/ DML/GMP certificate
of API manufacturer issued by
regulatory authority of country of
origin.
HYDROCHLORTHIAZIDE:
M/s Suzhou Lixin Pharmaceutical Co. Ltd, China: copy of GMP
Certificate No. JS20140325 issued by Jiangsu Food and Drug
Administration China, valid up to 25-08-2019 is submitted.
AMLODIPINE BESYLATE:
M/s Hetero Drugs Limited (Unit-IV), India: copy of GMP Certificate
No. 6208/E (G)/TS/2017 issued by Drugs Control Administration
(Telangana) India, valid up to 21-04-2018 is submitted.
OLMESARTAN MEDOXOMIL:
M/s Glenmark Pharmaceuticals Ltd. India: copy of GMP Certificate
No. 1708289 issued by Food & Drugs Control Administration
(Gujarat) India, valid up to 18-08-2019 is submitted.
5. Mechanism for Vendor pre-
qualification The firm has submitted SOP for Mechanism for Vendor pre-
qualification.
6. Certificate of analysis of the API,
reference standards and impurity
standards
Copy of COAs of all three APIs, have been submitted. Detail is
as under API name Batch No. DOM
Olmesartan medoxomil 83170554
99.6%
09-2017
Olmesartan medoxomil
Standard
TRC Canada
27-SSR-73-1
98%
Olmesartan Olefinic Impurity
Synpure Labs
Olmesartan Related Compund A
Synpure Labs
Olmesartan Impurity A
Olmesartan N-Alkyl Impurity
Amlodipine besilate AM0331216
99.37% Anhy.
12-2016
Amlodipine Working
standard
5-SCC-113-1
98%
Hydrochlorthiazide C01-20170102
101.2%
12-2016
Hydrochlorthiazide
Working Standard
2-SCC-58-1
98%
Impurity A Lixin
Impurity B Lixin0
Amlodipine Working standard Storage Condition Freezer.
7. Documents for the procurement of
excipients used in product
development?
The firm has submitted copy of Purchase Order/Invoices for the
procurement of excipients used in product development
Minutes of 294th Meeting of Registration Board | 323
8. List of qualified staff involved in
product development with relevant
experience.
The firm has submitted copy of List of qualified staff involved in
product development comprising of 16 members.
Production Data
9. Authorized Protocols/SOP for the
development & stability testing of trial
batches.
The firm has submitted copy of “Authorized protocols/SOP for
Development.
10. Complete batch manufacturing record
of three stability batches.
The firm has submitted copy of Batch Manufacturing Record and
Batch Packaging Record of the following 03 Batches: Batch No. Batch Size Mfg. Date
Trial No.01 1500 Tablets 02-2018
Trial No.02 1500 Tablets 02-2018
Trial No.03 1500 Tablets 02-2018
11. Record of remaining quantities of
stability batches.
Batch No. Remaining tablets
Accelerated
Remaining tablets
Real time
Trial No.01 110 216
Trial No.02 110 234
Trial No.03 110 234
QA / QC DATA
12. Record of Digital data logger for
temperature and humidity monitoring
of stability chambers (real time and
accelerated)
The firm has submitted photocopies of printouts of data logger charts
for Real Time and Accelerated Conditions starting from 02-2018 to
08-2018.
13. Method used for analysis of API along
with COA.
COA of supplier along with COA of manufacturer of finished
product.
14. Method used for analysis of FPP &
complete record of testing of stability
batches (i.e. chromatograms, lab
reports, raw data sheets etc.)
The firm has submitted following documents:
copy of Product Specifications & Method of analysis
Stability Protocols.
Analytical method validation report.
Record of testing of stability batches.
15. Reports of stability studies of API from
manufacturer.
Olmesartan medoxomil
Accelerated: 6 month
Long term : 36 month.
Amlodipine Besilate
Accelerated: 6 month
Long term : 36 month.
Hydrochlorthiazide
Accelerated: 6 month
Long term : 36 month.
16. Analysis reports for excipients used. The firm has submitted photocopies of its own Analytical reports for
all excipients used in product development of Sofvasc Trio Tablets.
Excipient Batch No. Supplier
Red Color 40
Lake
2016118 M.S. Corporation
Avicel pH 200 175012012 Blanver
Magnesium
Stearate
MS-T-17015 S Kank Healthcare, India
Titanium Dioxide 170216 Al-Burque
Manufacturer: Jiangsu
Hongyuan
Minutes of 294th Meeting of Registration Board | 324
Pharmacoat 606 7078281 CBC Co. Ltd
Manufacturer
Shin Etsu Chemical
Croscarmellose
Sodium
D205160059 Irfan Traders
Manufacturer
Accent Microcell, India
Starch C7111618 Rafhan Maize
17. Drug-excipients compatibility studies. The firm has not performed Drug-excipients compatibility
studies and has referred to monographs of Hand-book of
Pharmaceutical Excipients in this regard.
Moreover, they have claimed that Ingredients of Sofvasc Trio
and Tribenzor are same. However, the coating material is not similar.
Tribenzor Sofvasc Trio Tablet
Silicified MCC MCC
Pregelatinized Starch Starch
Croscarmellose Sodium Croscarmellose Sodium
Magnesium Stearate Magnesium Stearate
PVA HPMC
PEG 3350 -
Titanium Dioxide Titanium Dioxide
Talc -
Iron Oxide Red Iron Oxide Red
18. Record of comparative dissolution data. Firm has submitted comparative Dissolution studies report. The
details of reference product & Sample product are as follows: Feature Reference
product
Product of M/s
Wilson
Brand
name
Tribenzor
40/10/12.5mg Sofvasc Trio
Tablet
Batch No. 0004213 Trail 01
Comparative dissolution studies have been performed in
following mediums:
i. pH 1.2 HCl buffer
ii. Acetate buffer pH 4.5
iii. Phosphate Buffer pH 6.8
19. Compliance Record of HPLC software
21CFR & audit trail reports on product
testing.
Firm has submitted audit trail reports of stability studies of
applied formulation
Deficiencies/ Short-comings Firms Response
Submit raw data sheets of all time points. Provide
concentrations of standard and sample solution used in
assay and dissolution, as it is not clear from the
provided method.
Impurities analysis not performed for finished
product. Clarify and justify.
Potency adjustment has not been done for
API’s as evident in BMR. Clarify and justify.
Firm has submitted raw data sheets mentioning
potency of API instead of standard in the calculations
having purity 100%.
Firm has submitted that stability studies of finished
product percentage of all three APIs are found to be
within limits i.e. no degradation in results observed
uptil now nd committed if any variations in result
observed we will perform degradation studies and will
submit data.
Firm has submitted potency adjustment is not required
as assay is 100% as per BMR.
Minutes of 294th Meeting of Registration Board | 325
The firms dissolution Specs are NLT 85% is dissolved in 45 minutes whereas, innovators specs mentions 30
minutes.
Previous Decision: Registration Board deferred the case for justification of limits for Dissolution test in terms of
time, since reference product literature declare the dissolution time as 30 minutes whereas firm has applied limit
of 45 minutes for dissolution test (M-292).
Evaluation by PEC:
The firm has submitted that it is committed to perform dissolution test of our applied formulation as per innovator’s
specification at next time points of stability data. Similarly we will perform dissolution test as per innovator on our
commercial batches.
Discussion: Registration Board deliberated on the dissolution specifications and acceptance criteria submitted by
the firm and keeping in view its decision of 293rd meeting decided to accept the dissolution specifications since it
falls under the definition of immediate release drug product.
Decision: Registration Board decided as follows:
Accept the stability study data as the dissolution specifications falls within the definition of
immediate release drug product and approved registration of Sofvasc Trio Tablets 40/10/12.5mg
with Innovator’s specifications by M/s Wilson’s Pharmaceuticals, I-9, Industrial Area Islamabad,
wherein manufacturer will adopt the dissolution specifications i.e. NLT Q at 30 minutes for
commercial production batches.
Furthermore, manufacturer will place first three production batches on long term stability
studies throughout proposed shelf life and on accelerated studies for six months.
Sr.
No.
Name & Address
of Manufacturer /
Applicant
Brand Name
(Proprietary Name +
Dosage Form + Strength),
Composition,
Pharmacological Group,
Finished Product
Specification
Type of Form,
Initial Diary & Date,
Fee (including
differential fee),
Demanded Price / Pack
size
International Availability / Local
Availability
GMP Inspection Report Date &
Remarks
382. M/s Pharmatec
Pakistan (Pvt.)
Limited, D-86/A,
S.I.T.E., Karachi.
Tigrelor 90mg tablet
Each film-coated tablet
contains:
Ticagrelor...90mg
(Platelet Aggregation
Inhibitor)
Innovators’ Specifications
Form- 5
Dy.No.931
Dated: 22-12-2014
Rs.50,000/-
(17-12-2014)
2 x 10’s ; as per SRO
Brilinta 90 mg film-coated tablets
of M/s AstraZeneca UK Limited
(MHRA Approved) / Not
applicable
Last GMP inspection was
conducted on 12-12-2017 and
GMP certificate was issued on 15-
12-2017.
STABILITY STUDY DATA
Drug Tigrelor 90mg tablet
Name of Manufacturer M/s Pharmatec Pakistan (Pvt.) Limited, D-86/A, S.I.T.E., Karachi.
Manufacturer of API M/s Nantong Chanyoo Pharmatech Co., Ltd. China
API Lot No. RD-TG-201709061
Description of Pack
(Container closure system)
Alu- Alu Blister
Stability Storage Condition Real time : 30°C ± 2°C / 65% ± 5% RH
Accelerated: 40°C ± 2°C / 75% ± 5% RH
Time Period Real time: 06 months
Accelerated: 06 months
Frequency Accelerated: 0, 3, 6 (month)
Real Time: 0, 3, 6, 9, 12 (months)
Minutes of 294th Meeting of Registration Board | 326
Batch No. 17PD064TICT05 17PD081TICT06 17PD089TICT07
Batch Size 2500 tablets 2500 tablets 2500 tablets
Manufacturing Date Nov-2017 Dec-2017 Dec-2017
Date of Initiation 29-01-2018 29-01-2018 30-01-2018
No. of Batches 04
Date of Submission 16-08-2018 (27937)
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr.# Documents To Be Provided Status
1. CoA of API Firm has submitted copy of COA of Ticagrelor (Batch
# RD-TG-201709061) from M/s Nantong Chanyoo
Pharmatech Co., Ltd., China.
2. Approval of API by regulatory authority of country
of origin or GMP certificate of API manufacturer
issued by regulatory authority of country of origin.
Copy of GMP certificate (certificate No.2017006)
issued by Nantong Food & Drug Administration,
China. It is valid until 07/09/2020.
3. Protocols followed for conduction of stability study
and details of tests.
Yes
4. Data of 03 batches will be supported by attested
respective documents like chromatograms,
laboratory reports, data sheets etc.
Yes
5. Documents confirming import of API etc. The firm has submitted commercial invoice for the
import of Ticagrelor (5kg) from M/s. Nantong
Chanyoo Pharmatech Co., Ltd, China attested by
Assistant Director (I & E) DRAP, Karach dated 27-10-
2017.
6. All provided documents will be attested (name, sign
and stamp) for ensuring authenticity of data /
documents.
Yes
7. Commitment to continue real time stability study till
assigned shelf life of the product.
Yes
8. Commitment to follow Drug Specification Rules,
1978.
Yes
REMARKS OF EVALUATOR
Firm has submitted 6 months accelerated and 12 months real time stability study data of four batches.
REQUEST OF EXEMPTION FROM ON SITE INSPECTION
The firm has requested for Exemption from On-site Investigation of their submitted stability data and provided the
following documents in conjunction with the checklist approved by the Registration Board in its 278th Meeting:
Date of submission: 02-07-2019 vide diary no. 10339
Administrative Portion
1. Reference of last onsite panel
inspection for instant dosage form
conducted during last two years.
Firm has referred to onsite inspection report of their product “Apixa
2.5mg and 5mg (Apixaban) Tablets”, which was presented in 289th
meeting of Registration board. Registration Board decided to
approve registration of above stated drug product of M/s. Pharmatec
Pakistan (Private) Ltd, Karachi.
Date of inspection: 30-04-2019
According to inspection report, following points were confirmed.
The firm has 21CFR compliant HPLC software.
The firm has audit trail reports available.
Minutes of 294th Meeting of Registration Board | 327
2. Documents for the procurement of API
with approval from DRAP (in case of
import).
The firm has submitted commercial invoice for the import of
Ticagrelor (5kg) from M/s. Nantong Chanyoo Pharmatech Co., Ltd,
China attested by Assistant Director (I & E) DRAP, Karach dated
27-10-2017.
3. Documents for the procurement of
reference standard and impurity
standards.
The firm has submitted COAs of following working standards &
impurity Standards :
Ticagrelor working standard (B # WS201603001)
Ticagrelor working standard (B # WTG01-170401)
Impurity standards
TG16 WRS (B# WTG05-170401)
De-Ethoxyl of TG WRS (B# WTG06-170401)
4. Approval of API/DML/GMP certificate
of API manufacturer issued by
regulatory authority of country of
origin.
Copy of GMP certificate (certificate No.2017006) issued by
Nantong Food & Drug Administration, China. It is valid until
07/09/2020.
5. Mechanism for Vendor pre-
qualification
The firm has submitted SOP for evaluation of vendors.
6. Certificate of analysis of the API,
reference standards and impurity
standards
Firm has submitted copy of COA of Ticagrelor (Batch # RD-TG-
201709061) from M/s Nantong Chanyoo Pharmatech Co., Ltd.,
China.
7. Documents for the procurement of
excipients used in product
development?
The firm has submitted copy of Commercial invoices/COAs of the
excipients used in the formulation of applied product
8. List of qualified staff involved in
product development with relevant
experience.
The firm has submitted List of qualified staff involved in product
development department.
Production Data
9. Authorized Protocols/SOP for the
development & stability testing of trial
batches.
The firm has submitted copy of “Protocols/SOP for the Development
of Ticagrelor 90mg Tablet”.
10. Complete batch manufacturing record
of three stability batches.
The firm has submitted copy of Batch Manufacturing Records of
following 03 Batches:
Batch No. Batch Size Mfg. Date
17PD064TICT05 2500 Tablets 29-01-2018
17PD064TICT06 2500 Tablets 29-01-2018
17PD064TICT07 2500 Tablets 30-01-2018
11. Record of remaining quantities of
stability batches.
Trial No Total no. of
Tablets
For stability
testing
Tablets
used for
testing
Remaining
Quantities
of tablets
17PD064TICT05 2500 Tablets 1800
Tablets
700 tablets
17PD064TICT06 2500 Tablets 2330
Tablets
170 tablets
17PD064TICT07 2500 Tablets 2330
Tablets
170 tablets
QA / QC DATA
12. Record of Digital data logger for
temperature and humidity monitoring
of stability chambers (real time and
accelerated)
Firm has submitted photocopies of data logger record for chambers
used in Real Time & Accelerated stability studies of applied product
from 29-11-2017 to
Minutes of 294th Meeting of Registration Board | 328
13. Method used for analysis of API along
with COA.
The firm has submitted copy of Raw Material Specifications, Raw
Material Testing Procedures along with COA for Ticagrelor.
14. Method used for analysis of FPP &
complete record of testing of stability
batches (i.e. chromatograms, lab
reports, raw data sheets etc.)
The firm has submitted copy of Finished Product Testing Procedure
for “Ticagrelor 90mg Tablet” along with Stability Study Reports.
15. Reports of stability studies of API from
manufacturer.
The firm has submitted copy of 06 months Accelerated and 24
months Long term Stability Study Data of 03 Batches from M/s
Nantong Chanyoo Pharmatech Co., Ltd. China. The storage
conditions for real time stability data are 25±2oC/60±5%RH.
16. Analysis reports for excipients used. The firm has submitted copy of Analytical reports of excipients used.
17. Drug-excipients compatibility studies. The compatibility of Ticagrelor 900mg (API) and 40mg Sodium
lauryl sulphate (Excipient) was studied by HPLC analytic techniques
after storage of mixture under accelerated conditions. HPLC analysis
of these mixtures has not shown any significant physical and
chemical instability. Hence the study concludes that Ticagrelor and
sodium lauryl sulphate are compatible.
18. Record of comparative dissolution data. The firm has performed comparative dissolution profile at pH 1.2,
pH 4.5, pH 6.8 between Ticagrelor 90mg tablet and Brilinta 90mg
tablet. The results suggest similarity factor (f2) > 50 and difference
factor (f1) < 15 in all three media.
19. Compliance Record of HPLC software
21CFR & audit trail reports on product
testing.
The firm has submitted audit trail reports of “Ticagrelor 90mg
Tablet” from.
Sr.# Observations communicated Response by the applicant
1. Digital data logger record does not cover the
duration of stability study data. Clarification is
required.
Digital logger sheets which cover the duration stability
study data.
2. Justification is required for preparation of four
batches for the purpose of carrying out stability
studies.
The first batch exhibiting the batch number
17PD048TICT04, is the pre-formulation batch, the very
initial batch developed at every step of formulation
development, this supports in making decision. These
steps include process feasibility studies, formulation
optimization and manufacturing process.
3. Audit trail reports of only one date are submitted.
It is important to submit the audit trail reports at
all time points of stability studies as well as
comparative dissolution study.
Audit trail on the testing time point is submitted.
4. Polymorphic form of Ticagrelor API is required
to be submitted.
The firm has submitted that polymorphic form-II was
used and further stated that same form of molecule is
discussed in the patent of Astra Zeneca. The form-II of
Ticagrelor is confirmed by the melting points & X-ray
Diffraction.
Storage conditions under which stability studies were conducted are at 25oC±2oC/60%±5% RH.
Previous Decision: Deferred for submission of scientific justification for conducting API stability studies at storage
conditions of 25oC±2oC/60%±5% RH.
Response of the applicant: The firm has submitted that internationally API stability studies are conducted at
25oC±2 oC/60%±5%RH because majority of API manufacturer supplies their product to international market. When
we receive APIs, we keep them in controlled temperature i.e., 25oC. When we manufacture our finished product
with these APIs, we use to conduct stability studies of our products according to our stability Zone i.e., Zone IVA.
Minutes of 294th Meeting of Registration Board | 329
Previous Decision: Registration Board deferred the case for submission of valid GMP certificate of M/s Nantong
Chanyoo, Jiangsu province, China, issued by relevant Provincial or state Regulatory authority since the Nantong
Food and Drug Administration is not the relevant provincial regulatory authority (M-293).
Response of the firm: Firm has submitted copy of “License for Drug production” issued by the Jiangsu Food and
Drug Administration in the name of M/s Nantong Chanyoo Pharmatech Co., Ltd., China with License number “S.
20160512” and valid upto 31-12-2020.
The above cited certificate has been verified from the following web link of National Medical Product
Administration of China:
http://app1.sfda.gov.cn/datasearchcnda/face3/base.jsp?tableId=34&tableName=TABLE34&title=%D2%A9%C6
%B7%C9%FA%B2%FA%C6%F3%D2%B5&bcId=152911762991938722993241728138
Decision: Deferred for following submissions:
Submission of real term stability studies data of the product for atleast 1 year along with
degradation studies in the finished pharmaceutical product as per the decision of 290th meeting of
Registration Board since the firm has used API whose stability testing has not been done as per the
conditions of Zone IV-A.
Scientific justification for performance of drug excipient compatibility studies with only 1
excipient (i.e. Sodium lauryl sulphate).
Status whether form-II of Ticagrelor is confirmed by the melting points & X-ray Diffraction
by M/s Pharmatec or API manufacturer
Minutes of 294th Meeting of Registration Board | 330
CTD Applications (Deferred cases):
383. MODULE 1: ADMINISTRATIVE
Section Sub-
Section
Heading
1.1 Covering Letter and Fee Deposit Slip Submitted
Dy.No. 1528, dated 22-03-2019,
50,000/- dated 04-02-2019
1.2 Table of Contents (From Module 1 to Module 5) Submitted
1.3 Applicant Information Submitted
1.3.1 Name, address and contact details of Applicant / Marketing Authorization Holder:
M/s Martin Dow Limited., Plot 37, Sector 19, Korangi Industrial Area, Karachi
1.3.2 Name, address and contact details of Manufacturing site.
M/s Nabiqasim Industries Pvt. Ltd., 17/24, Korangi industrial Area, Karachi
1.3.3 Specify whether the Applicant is:
a. Manufacturer
b. Importer
c. Is involved in none of the above (contract giver)
1.3.4 Valid Drug Manufacturing License (DML) of manufacturer / Applicant or Drug Sale
License, whichever is applicable.
Copy of DML of manufacturing site is submitted.
Submitted
1.3.5 Evidence of approval of manufacturing facility / Approved Section from Licensing
Authority
Submitted
1.3.6 List of already approved registered drugs in this section
NA.
1.3.7 Identification of Signature(s) of authorized persons, Incharge Production, Quality Control
and Incharge Quality Assurance
NA
1.3.8 Manufacturer’s Site Master File and Credential (for importer)
Not applicable
1.4 Type of Application Submitted
1.4.1 Application is for the registration of:
New Drug Product (NDP)
Generic Drug Product (GDP)
1.4.1 Pharmaceutical product is intended for:
Domestic sale
Export sale
Domestic and Export sales
1.4.2 For imported products, please specify one of following:
Finished Pharmaceutical Product Import
Bulk Import and local repacking (specify status of bulk)
Bulk Import Local Repacking for Export purpose only
1.4.3 Contract Manufacturing as per Rule 20-A of Drugs (Licensing, Registering and
Advertising) Rules, 1976.
Domestic Manufacturing
Export Purpose Only
1.5 Detailed Information of Drug, Dosage From & Labelling Claims Submitted
1.5.1 Generic name with chemical name & synonyms of the applied drug.
1.5.2 Strength / concentration of drug of Active Pharmaceutical ingredient (API) per unit
Each vial contains:
Esomeprazole as sodium…………40mg
1.5.3 The proposed proprietary name / brand name under which the drug is intended to be sold
with trade mark certification / clearance.
Esomax IV 40mg Injection
Minutes of 294th Meeting of Registration Board | 331
1.5.4 Proposed Pack size and Proposed unit price of drug e.g., per tablet / capsule. Maximum
Retail Price (MRP) per pack shall also be mentioned.
1 vial; As per PRC
1.5.5 Pharmacotherapeutic Group of Active Pharmaceutical Ingredient (API)
Proton pump inhibitor (WHO ATC code= A02BC05)
1.5.6 Pharmacopoeial reference / Status of applied formulation
In-house
1.5.7 Route of administration
Intravenous (IV)
1.5.8 For Generic Drug Product, reference of other similar approved medicines with information
pertaining to Manufacturer name, brand name, strength, composition, registration number
& dosage form, Pack size and Price.
Acireg of Barret hodgson Pakistan
1.5.9 The registration status of applied drug in same molecule and salt, strength, dosage form,
container closure system, indications and route of administration etc. in other countries.
The status in reference regulatory authorities is mandatory to mention.
Nexium IV Injection (MHRA Approved)
1.5.10 Dosage form of applied drug
Esomax IV Injection 40mg/ml
Sterile , freeze –dried white colored powder in 5ml vial contains:
Esomeprazole sodium eq. to Esomeprazole……………40mg
1.5.11 Proposed label (outer (secondary) & inner (primary)) & color scheme in accordance with
Drug (Labelling & Packing) Rules, 1986 along with specimens
Attached
1.5.12 Description of Batch numbering system
Not submitted
1.5.13 Training evidence of technical staff with respect of manufacturing of applied drug
(mandatory in case of specially designed pharmaceutical product / Novel Dosage Form).
Not submitted
1.5.14 Summary of Product Characteristics (SmPC) including Prescribing Information (PI) along
with Patient information Leaflet (PIL) of the Finished Pharmaceuticals Product (FPP).
Submitted
1.5.15 Commitment / Undertaking that after registration of applied drug, the Pharmacovigilance
department of the applicant / manufacture is liable to impose similar restrictions, addition
of any clinical information (like in Indications, Contra-indications, Side effects,
Precautions, Dosage & Adverse Drug Reactions etc. in Summary of Product
Characteristics (SmPC), Labelling & Promotional material) or withdraw the drug from
market in Pakistan within fourteen days after knowing that such information (which was
not available or approved by the DRAP at the time of registration) / actions taken (for
safety reasons) by any reference / stringent drug regulatory agency / authority & also
inform the DRAP (Drug Regulatory Authority of Pakistan) for further action in this regard.
Submitted
1.5.16 Commitment / Undertaking that the applicant shall recall the defective Finished
Pharmaceutical Products (FPP) and notify the compliance to the authority along with detail
of actions taken by him as soon as possible but not more than ten days. The level of recall
shall also be defined.
Submitted
1.5.17 Commitment / Undertaking that in case of any false claim / concealing of information, the
DRAP has the right to reject the application at any time, before and even after approval or
registration of the product in case if proved so.
Submitted
1.5.18 Commitment / Undertaking that the firm shall follow the official pharmacopoeia
specifications for product / substance as published in the latest edition & shall update its
specification as per latest editions of the same. In case, the specifications of product /
Minutes of 294th Meeting of Registration Board | 332
substance not present in any official pharmacopoeia the firm shall establish the
specifications. In both cases, the validation of specifications shall be done by the applicant.
Submitted
1.5.19 Commitment / Undertaking that in case of any post approval change, the applicant shall
ensure that the product with both approvals shall not be available in the market at the same
time. And the product with new approvals shall be marketed only after consumption /
withdrawal of stock with previous approvals. The company shall be liable to inform the
same regarding marketing status of product to the DRAP after getting such post-
registration approvals.
Not submitted
1.5.20 Other commitment e.g., regarding stability studies etc.
Submitted
1.5.21 Protocols along with the commitment to follow Good Laboratory Practices (GLP) by the
Manufacturer.
Not submitted
1.5.22 Protocols to implement Good Pharmacovigilance Practice by the Pharmacovigilance
department/section of the Manufacturer / Company.
Not submitted
1.6 Miscellaneous Information Not submitted
1.6.1 Information on Prior-related Applications
1.6.2 Appendix
1.6.3 Electronic Review Package
1.6.4 QIS (Quality Information Summary)
1.6.5 Drug Substance related Document including following:
a. Name and address of API manufacturer.
b. Approval of manufacturing facility of API by regulatory body of country and
validity.
c. Vendor qualification / audit is
Document based
Site inspection based
d. Reason for point c.
The firm has submitted copy of contract manufacturing agreement dated 12th March, 2019
between M/s Martin Dow Limited, Karachi and Nabiqasim Industries Pvt. Ltd., Karachi.
Minutes of 294th Meeting of Registration Board | 333
MODULE 2: CTD SUMMARIES
2.1 Overall CTD Table of Content Submitted
2.2 CTD Introduction Submitted
2.3 Quality Overall Summary (QOS)* Submitted
(Detailed information regarding QOS may be found at the following link) https://extranet.who.int/prequal/sites/default/files/documents/82%20Module%202.3%20QOS_March2017
.docx
1.3 QUALITY OVERALL SUMMARY (QOS)
2.3 2.3.S Drug substance (API)
2.3.S.1 General information Submitted
2.3.S.2 Manufacture Submitted
2.3.S.3 Characterization Submitted
2.3.S.4 Control of drug substance Submitted
2.3.S.5 Reference standards Submitted
2.3.S.6 Container closure system Submitted
2.3.S.7 Stability Submitted
Comments
2.3.P Drug product
2.3.P.1 Description and composition of the drug product Submitted
2.3.P.2 Pharmaceutical development Submitted
2.3.P.2.1 Components of the drug product
2.3.P.2.1.1 Drug substance (API) Submitted
2.3.P.2.1.2 Excipients Submitted
2.3.P.2.2 Finished Pharmaceutical Product Submitted
2.3.P.2.3 Manufacturing process development Submitted
2.3.P.2.4 Container closure system Submitted
2.3.P.3 Manufacture Submitted
2.3.P.4 Control of excipients Submitted
2.3.P.5 Control of drug product Submitted
2.3.P.6 Reference standards and materials Submitted
2.3.P.7 Container closure system Submitted
2.3.P.8 Stability Submittted
Comments
2.4
Non-Clinical Overview Not applicable
2.5 Clinical Overview Not applicable
2.6 Non-Clinical Written and Tabulated Summaries (Normally not required for generics) Not applicable
2.7 Clinical summary Not applicable
Minutes of 294th Meeting of Registration Board | 334
MODULE 3: QUALITY
3.1 Table of Contents of Module 3 Submitted
3.2 Body of Data Submitted
3.2.S DRUG SUBSTANCE (API)
3.2.S.1
GENERAL INFORMATION (May not refer to DMF)
3.2.S.1.1 Nomenclature Submitted
3.2.S.1.2 Structure Submitted
3.2.S.1.3 General properties Submitted
Comments
3.2.S.2 MANUFACTURER
3.2.S.2.1 Manufacturer(s) Submitted
3.2.S.2.2 Description of Manufacturing Process and Process Controls Submitted
3.2.S.2.3 Control of Materials Not submitted
3.2.S.2.5 Process Validation and/or Evaluation Not submitted
The firm has not submitted information of control of materials and Process validation or evaluation
as specified in 3.2.S.2.3 and 3.2.S.2.5. The firm has claimed that this information is confidential hence
it will be covered in closed part of DMF.
3.2.S.3
CHARACTERIZATION
3.2.S.3.1 Elucidation of Structure and other Characteristics Submitted
3.2.S.3.2 Impurities Submitted
Comments
3.2.S.4
CONTROL OF DRUG SUBSTANCE (API)
3.2.S.4.1
Specification Submitted
Comments
3.2.S.4.2
Analytical procedures Submitted
Comments
3.2.S.4.3
Validation of analytical procedures Submitted
(API that meets Pharmacopeia standards MUST provide verification of procedures)
1. Spectra and chromatograms for reference standards and test samples
(ref. std. can be located in 3.2.S.5)
Comments
3.2.S.4.4
Batch analysis
1. Certificate of analysis (COA) specifications and test results from drug
substance (API) manufacturer(s)
2. Drug product manufacturer’s certificate of analysis with API lot numbers
Comments
3.2.S.4.5 Justification of specifications Submitted
Comments
3.2.S.5
REFERENCE STANDARDS OR MATERIALS (Do NOT refer to DMF) Submitted
Comments
3.2.S.6
CONTAINER CLOSURE SYSTEMS Submitted
Storage temperature of the API is between 2°C and 8°C.
3.2.S.7 STABILITY
Minutes of 294th Meeting of Registration Board | 335
3.2.S.7.1 Stability Summary and Conclusions Submitted
3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment Submitted
3.2.S.7.3 Stability Data Submitted
Stability study completed up to 6 months at accelerated condition Viz. 25oC±2oC/ 60% ±5% RH and
study completed up to 60 months at long term condition Viz.5oC±3oC.
3.2.P DRUG PRODUCT
3.2.P.1
DESCRIPTION AND COMPOSITION OF THE DRUG PRODUCT Submitted
1. Unit composition with indication of the function of the inactive ingredient(s)
2. Formulation
Comments
3.2.P.2
PHARMACEUTICAL DEVELOPMENT
3.2.P.2.1 Components of the Drug Product
3.2.P.2.1.1 Drug Substance Submitted
3.2.P.2.1.2 Excipients Submitted
3.2.P.2.2 Drug Product
3.2.P.2.2.1 Formulation Development Submitted
Pharmaceutical Equivalence through Comparative Dissolution Profile
Submitted
3.2.P.2.2.2 Overages Not applicable
3.2.P.2.2.3 Physicochemical and Biological Properties Submitted
3.2.P.2.3 Manufacturing Process Development Submitted
3.2.P.2.4 Container Closure System Submitted
3.2.P.2.5 Microbiological Attributes Submitted
3.2.P.2.6 Compatibility Submitted
The firm has submitted following:
Stability of this product under various conditions has been monitored since compatibility study
was not performed. Results from stability studies proved that active ingredients and packaging
material are well suited, and do not exert any adverse impact on finished pharmaceutical product
performance.
3.2.P.3 MANUFACTURE
3.2.P.3.1 Manufacturer(s) Submitted
1. Name and full address(es) of the facility(ies)
2. Contact name, phone and fax numbers, email address
Comments
3.2.P.3.2 Batch formula Submitted
Largest intended commercial batch size
Comments
3.2.P.3.3 Description of manufacturing process and process controls Submitted
1. Description of the manufacturing process and facility
2. Master production batch record(s) for largest intended production runs (no
more than 10x pilot batch) with equipment specified
3. Master packaging records for intended marketing container(s)
Comments
3.2.P.3.4 Controls of critical steps and intermediates Submitted
Comments
3.2.P.3.5 Process validation and/or evaluation Submitted
3.2.P.4 CONTROL OF EXCIPIENTS
Minutes of 294th Meeting of Registration Board | 336
3.2.P.4.1 Specifications Submitted
1. Testing specifications (including identification and characterization)
2. Supplier’s COA (specifications and test results)
Comments
3.2.P.4.2 Analytical procedures Submitted
Comments
3.2.P.4.3 Validation of analytical procedures Submitted
Comments
3.2.P.4.4 Justification of specifications (as applicable) Submitted
3.2.P.4.5 Excipients of Human or Animal Origin Not applicable
3.2.P.4.6 Novel Excipients Not applicable
Comments
3.2.P.5 CONTROLS OF DRUG PRODUCT
3.2.P.5.1
Specification(s) Submitted
Comments
3.2.P.5.2
Analytical procedures Submitted
Comments
3.2.P.5.3
Validation of analytical procedures Not submitted
(if using Pharmacopoeial procedure, must provide verification of Pharmacopoeial
procedure)
You have not submitted validation of analytical procedures under control of drug
product. It is very important to submit the data as specified in 3.2.P.5.3 especially where
in-house method is developed.
3.2.P.5.4
Batch analysis Submitted
Certificates of Analysis for finished dosage form
Comments
3.2.P.5.5
Characterization of impurities Submitted
All potential degradation products should be listed in a tabular format
Comments
3.2.P.5.6
Justification of specifications Submitted
All potential degradation products should be listed in a tabular format
Comments
3.2.P.6 Reference Standards or Materials Not submitted
Comments
3.2.P.7 CONTAINER CLOSURE SYSTEM Submitted
1. Summary of container closure system
2. Component specifications and test data
3. Packaging configuration(s) and size(s)
4. Container/Closure Testing (recommended additional testing for all
plastic)
a. Solid orals: water permeation, light transmission
b. Liquids: leachables, extractables, light transmission
i. Injectables with rubber stoppers: extractables
Information in various sections from 3.2.P.5.3 to 3.2.P.5.6 as well as 3.2.P.6 of module
III is not submitted. Relevant information is required to be submitted.
Minutes of 294th Meeting of Registration Board | 337
3.2.P.8 STABILITY
3.2.P.8.1 Stability summary and conclusion (Finished Dosage Form) Submitted
Stability protocol submitted
Expiration dating period for marketed packaging
Expiration dating period for bulk packaging (if applicable)
Comments
3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment Submitted
Comments
3.2.P.8.3 Stability Submitted
The firm has submitted stability sheets for 6 months at accelerated conditions and 24
months at real time conditions for three batches of their already marketed product Es-
Loprot 40mg IV Injection. However, the firm has not submitted raw data sheets and
chromatograms.
Sr.
No.
Observations communicated Response of the applicant
1. Identification of Signature(s) of authorized persons,
Incharge Production, Quality Control and Incharge
Quality Assurance is not submitted.
Submitted
2. Quantitative composition of applied formulation
contains Mannitol as mentioned in 2.3.P.1 and
3.3.P.1. However, reference product in MHRA does
not mention such excipient. Justification /
Clarification is required and also the compatibility
studies of API with this excipient is required.
The firm has submitted revised formulation which
does not contain mannitol. Accordingly firm has
submitted BMR and formulation for
Esomeprazole 40mg injection. However, firm has
just submitted template for BMR which does not
contain actual formulation development.
3. You have not submitted validation of analytical
procedures under control of drug product. It is very
important to submit the data as specified in 3.2.P.5.3
especially where in-house method is developed.
Not submitted
4. Information in various sections from 3.2.P.5.3 to
3.2.P.5.6 as well as 3.2.P.6 of module III is not
submitted. Relevant information is required to be
submitted.
The firm has submitted Batch Analyses,
Characterization of impurities and justification of
finished product specifications.
5. You have not submitted supporting documents like
raw data sheets and chromatograms against
submitted stability summary sheets of applied
formulation.
The firm has not submitted chromatograms of
initial time point of applied formulation. The firm
has submitted the data of already marketed
product Es-Loprot 40mg IV Injection of M/s
NabiQasim Industries Pvt. Ltd. karachi.
6. Commitments as specified in sections 1.5.15,
1.5.16, 1.5.17, 1.5.19 and protocols as specified in
sections 1.5.21, 1.5.22 of module I are required to
be submitted.
Submitted
Previous Decision: Registration Board deferred the case for following observations: (M-292)
Scientific justification for the relevance of previously submitted data in section 3.2.P against
recently revised master formulation.
Submission of validation of analytical procedures as specified in 3.2.P.5.3 of module III of CTD.
Submission of chromatograms and raw data sheets of three batches of stability study data of initial
time and details of reference standards and materials as specified in 3.2.P.6.
Evaluation by PEC:
As per information from NabiQasim (contract manufacturer), they have developed the formulation of
Esomeprazole 40mg Injection as per innovator without mannitol and conducted its 06 months stability
studies. Based on satisfactory stability data, BMR of actual product is developed.
01 set of Blank BMR of Esomeprazole 40mg Injection is submitted.
Minutes of 294th Meeting of Registration Board | 338
03 sets of filled BMR of developmental batches of Esomeprazole 40mg Injection with their stability
data, raw data sheets and chromatograms are submitted.
For validation of analytical procedures as specified in 3.2.P.5.3, the firm has submitted following
documents:
Method validation protocol
Method validation report
For reference standard, firm has submitted following justification:
“For the analysis of Esomeprazole in lyophilized injection, Reference standard of omeprazole is used as they are
isomer of each other and contain same formula. This practice was adopted from United states Pharmacopoea, as
they are also using Omeprazole as a reference standard for the analysis of Esomeprazole Magnesium delayed
release capsules.”
Verification of Authenticity of formulation of Esomax (Esomeprazole) 40mg IV Injection by M/s. Martin
Dow Limited, K.I.A. Karachi.
Reference No: F.1-2/2020-PEC dated 02nd January, 2020.
Investigation Date and Time: 6th January, 2020. (Afternoon)
Investigation Site: Factory premises of M/s. Nabi Qasim Industries Pvt. Ltd. Karachi.
Background:
The Pharmaceutical Evaluation and Registration Division considered the application of M/s Martin Dow Limited
for registration of Esomax (Esomeprazole) 40mg IV Injection manufactured by M/s Nabi Qasim Industries on
contract manufacturing basis. The Chairman Registration Board constituted a two member panel for investigation
of the query mentioned in the scope of investigation:
Composition of Panel:
1. Ms. Hira Bhutto, Assistant Director, CDL, DRAP, Karachi
2. Dr. Affan Ali Qureshi, Assistant Director, CDL, DRAP, Karachi.
Scope of investigation:
On Site Investigation/verification of the following point:
1. Verification of formulation for use of mannitol as the firm initially submitted the formulation containing
mannitol and upon query for justification they replied that their formulation do not contain mannitol and
their formulation is as per innovator’s product.
Details of Investigation:
1. The panel visited the firm, reviewed the batch records including dispensing, production records, log books,
the available software (ERP), audit trail for the ERP on the system and found that mannitol was never
dispensed for the manufacturing of any batch of the said product:
2. As per record available with the firm the formulation of product is as under:
a. Esomeprazole Sodium (Pyrogen Free) 42.5mg/vial
b. Di Sodium EDETATE (Injectable Grade) 1mg/vial
c. Sodium Hydroxide (Injectable Grade) 0.7mg/vial
d. Water for injection q.s. 2.1ml
Conclusion & Recommendation:
1. On the basis of the site visit, documents reviewed and personnel inquired the panel reached on conclusion
that the firm has not used mannitol in their formulation and their formulation is as per innovator product.
Therefore, in opinion of the panel the firm may kindly be granted registration of the product with current
formulation if there is no more query.
Decision: Registration Board decided to approve registration of Esomax IV 40mg Injection with
Innovator’s specifications by M/s Martin Dow Limited., Plot 37, Sector 19, Korangi Industrial Area,
Karachi.
Minutes of 294th Meeting of Registration Board | 339
384. ESVIN INJECTION 40mg
Section Sub-
Section
Heading
1.1 Covering Letter and Fee Deposit Slip Submitted
Dy.No.7859 , dated 31-05-2019, Rs.50,000/- dated 29-05-2019
1.2 Table of Contents (From Module 1 to Module 5) Submitted
1.3 Applicant Information Submitted
1.3.1 Name, address and contact details of Applicant / Marketing Authorization Holder:
M/s. Martin Dow Marker Limited, 7- Jail Road, Quetta.
1.3.2 Name, address and contact details of Manufacturing site.
M/s Nabiqasim Industries Pvt. Ltd., 17/24, Korangi industrial Area, Karachi
1.3.3 Specify whether the Applicant is:
d. Manufacturer
e. Importer
f. Is involved in none of the above (contract giver)
1.3.4 Valid Drug Manufacturing License (DML) of manufacturer / Applicant or Drug Sale
License, whichever is applicable.
Copy of DML of manufacturing site is submitted.
1.3.5 Evidence of approval of manufacturing facility / Approved Section from Licensing Authority
Submitted
1.3.6 List of already approved registered drugs in this section
Not submitted
1.3.7 Identification of Signature(s) of authorized persons, Incharge Production, Quality Control
and Incharge Quality Assurance
Not submitted
1.3.8 Manufacturer’s Site Master File and Credential (for importer)
Not applicable
1.4 Type of Application Submitted
1.4.1 Application is for the registration of:
New Drug Product (NDP)
Generic Drug Product (GDP)
1.4.1 Pharmaceutical product is intended for:
Domestic sale
Export sale
Domestic and Export sales
1.4.2 For imported products, please specify one of following:
Finished Pharmaceutical Product Import
Bulk Import and local repacking (specify status of bulk)
Bulk Import Local Repacking for Export purpose only
1.4.3 Contract Manufacturing as per Rule 20-A of Drugs (Licensing, Registering and Advertising)
Rules, 1976.
Domestic Manufacturing
Export Purpose Only
1.5 Detailed Information of Drug, Dosage From & Labelling Claims Submitted
1.5.1 Generic name with chemical name & synonyms of the applied drug.
1.5.2 Strength / concentration of drug of Active Pharmaceutical ingredient (API) per unit
Each vial contains:
Esomeprazole as sodium…………40mg
1.5.3 The proposed proprietary name / brand name under which the drug is intended to be sold
with trade mark certification / clearance.
ESVIN INJECTION 40mg
1.5.4 Proposed Pack size and Proposed unit price of drug e.g., per tablet / capsule. Maximum Retail
Price (MRP) per pack shall also be mentioned.
1 vial; As per PRC
Minutes of 294th Meeting of Registration Board | 340
1.5.5 Pharmacotherapeutic Group of Active Pharmaceutical Ingredient (API)
Proton pump inhibitor (WHO ATC code= A02BC05)
1.5.6 Pharmacopoeial reference / Status of applied formulation
In-house
1.5.7 Route of administration
Intravenous (IV)
1.5.8 For Generic Drug Product, reference of other similar approved medicines with information
pertaining to Manufacturer name, brand name, strength, composition, registration number &
dosage form, Pack size and Price.
Acireg of Barret hodgson Pakistan
1.5.9 The registration status of applied drug in same molecule and salt, strength, dosage form,
container closure system, indications and route of administration etc. in other countries. The
status in reference regulatory authorities is mandatory to mention.
Nexium IV Injection (MHRA Approved)
1.5.10 Dosage form of applied drug
ESVIN Injection 40mg
Sterile , freeze –dried white colored powder in 5ml vial contains:
Esomeprazole sodium eq. to Esomeprazole……………40mg
1.5.11 Proposed label (outer (secondary) & inner (primary)) & color scheme in accordance with
Drug (Labelling & Packing) Rules, 1986 along with specimens
Attached
1.5.12 Description of Batch numbering system
Not provided
1.5.13 Training evidence of technical staff with respect of manufacturing of applied drug
(mandatory in case of specially designed pharmaceutical product / Novel Dosage Form).
Not provided
1.5.14 Summary of Product Characteristics (SmPC) including Prescribing Information (PI) along
with Patient information Leaflet (PIL) of the Finished Pharmaceuticals Product (FPP).
Attached
1.5.15 Commitment / Undertaking that after registration of applied drug, the Pharmacovigilance
department of the applicant / manufacture is liable to impose similar restrictions, addition of
any clinical information (like in Indications, Contra-indications, Side effects, Precautions,
Dosage & Adverse Drug Reactions etc. in Summary of Product Characteristics (SmPC),
Labelling & Promotional material) or withdraw the drug from market in Pakistan within
fourteen days after knowing that such information (which was not available or approved by
the DRAP at the time of registration) / actions taken (for safety reasons) by any reference /
stringent drug regulatory agency / authority & also inform the DRAP (Drug Regulatory
Authority of Pakistan) for further action in this regard.
Submitted
1.5.16 Commitment / Undertaking that the applicant shall recall the defective Finished
Pharmaceutical Products (FPP) and notify the compliance to the authority along with detail
of actions taken by him as soon as possible but not more than ten days. The level of recall
shall also be defined.
Submitted
1.5.17 Commitment / Undertaking that in case of any false claim / concealing of information, the
DRAP has the right to reject the application at any time, before and even after approval or
registration of the product in case if proved so.
Submitted
1.5.18 Commitment / Undertaking that the firm shall follow the official pharmacopoeia
specifications for product / substance as published in the latest edition & shall update its
specification as per latest editions of the same. In case, the specifications of product /
substance not present in any official pharmacopoeia the firm shall establish the
specifications. In both cases, the validation of specifications shall be done by the applicant.
Submitted
Minutes of 294th Meeting of Registration Board | 341
1.5.19 Commitment / Undertaking that in case of any post approval change, the applicant shall
ensure that the product with both approvals shall not be available in the market at the same
time. And the product with new approvals shall be marketed only after consumption /
withdrawal of stock with previous approvals. The company shall be liable to inform the same
regarding marketing status of product to the DRAP after getting such post-registration
approvals.
Submitted
1.5.20 Other commitment e.g., regarding stability studies etc.
Submitted
1.5.21 Protocols along with the commitment to follow Good Laboratory Practices (GLP) by the
Manufacturer.
Not applicable
1.5.22 Protocols to implement Good Pharmacovigilance Practice by the Pharmacovigilance
department/section of the Manufacturer / Company.
Not submitted
1.6 Miscellaneous Information Not submitted
1.6.1 Information on Prior-related Applications
1.6.2 Appendix
1.6.3 Electronic Review Package
1.6.4 QIS (Quality Information Summary)
1.6.5 Drug Substance related Document including following:
e. Name and address of API manufacturer.
f. Approval of manufacturing facility of API by regulatory body of country and
validity.
g. Vendor qualification / audit is
Document based
Site inspection based
h. Reason for point c.
The firm has submitted copy of contract manufacturing agreement dated 12th March, 2019
between M/s Martin Dow Limited, Karachi and Nabiqasim Industries Pvt. Ltd., Karachi.
Minutes of 294th Meeting of Registration Board | 342
MODULE 2: CTD SUMMARIES
2.1 Overall CTD Table of Content Submitted
2.2 CTD Introduction Submitted
2.3 Quality Overall Summary (QOS)* Submitted
(Detailed information regarding QOS may be found at the following link) https://extranet.who.int/prequal/sites/default/files/documents/82%20Module%202.3%20QOS_March2017
.docx
1.4 QUALITY OVERALL SUMMARY (QOS)
2.3 2.3.S Drug substance (API)
2.3.S.1 General information Submitted
2.3.S.2 Manufacture Submitted
2.3.S.3 Characterization Submitted
2.3.S.4 Control of drug substance Submitted
2.3.S.5 Reference standards Submitted
2.3.S.6 Container closure system Submitted
2.3.S.7 Stability Submitted
Comments
2.3.P Drug product
2.3.P.1 Description and composition of the drug product Submitted
2.3.P.2 Pharmaceutical development Submitted
2.3.P.2.1 Components of the drug product
2.3.P.2.1.1 Drug substance (API) Submitted
2.3.P.2.1.2 Excipients Submitted
2.3.P.2.2 Finished Pharmaceutical Product Submitted
2.3.P.2.3 Manufacturing process development Submitted
2.3.P.2.4 Container closure system Submitted
2.3.P.3 Manufacture Submitted
2.3.P.4 Control of excipients Submitted
2.3.P.5 Control of drug product Submitted
2.3.P.6 Reference standards and materials Submitted
2.3.P.7 Container closure system Submitted
2.3.P.8 Stability Submittted
Comments
2.4
Non-Clinical Overview Not applicable
2.5 Clinical Overview Not applicable
2.6 Non-Clinical Written and Tabulated Summaries (Normally not required for generics) Not applicable
2.7 Clinical summary Not applicable
Minutes of 294th Meeting of Registration Board | 343
MODULE 3: QUALITY
3.1 Table of Contents of Module 3 Submitted
3.2 Body of Data Submitted
3.2.S DRUG SUBSTANCE (API)
3.2.S.1
GENERAL INFORMATION (May not refer to DMF)
3.2.S.1.1 Nomenclature Submitted
3.2.S.1.2 Structure Submitted
3.2.S.1.3 General properties Submitted
Comments
3.2.S.2 MANUFACTURER
3.2.S.2.1 Manufacturer(s) Submitted
3.2.S.2.2 Description of Manufacturing Process and Process Controls Submitted
3.2.S.2.3 Control of Materials Not submitted
3.2.S.2.5 Process Validation and/or Evaluation Not submitted
The firm has not submitted information of control of materials and Process validation or
evaluation as specified in 3.2.S.2.3 and 3.2.S.2.5. The firm has claimed that this information is
confidential hence it will be covered in closed part of DMF.
3.2.S.3
CHARACTERIZATION
3.2.S.3.1 Elucidation of Structure and other Characteristics Submitted
3.2.S.3.2 Impurities Submitted
Comments
3.2.S.4
CONTROL OF DRUG SUBSTANCE (API)
3.2.S.4.1
Specification Submitted
Comments
3.2.S.4.2
Analytical procedures Submitted
Comments
3.2.S.4.3
Validation of analytical procedures Submitted
(API that meets Pharmacopeia standards MUST provide verification of
procedures)
2. Spectra and chromatograms for reference standards and test samples
(ref. std. can be located in 3.2.S.5)
Comments
3.2.S.4.4
Batch analysis
3. Certificate of analysis (COA) specifications and test results from drug
substance (API) manufacturer(s)
4. Drug product manufacturer’s certificate of analysis with API lot numbers
Comments
3.2.S.4.5 Justification of specifications Submitted
Comments
3.2.S.5
REFERENCE STANDARDS OR MATERIALS (Do NOT refer to DMF) Submitted
Comments
3.2.S.6
CONTAINER CLOSURE SYSTEMS Submitted
Storage temperature of the API is between 2°C and 8°C.
3.2.S.7 STABILITY
Minutes of 294th Meeting of Registration Board | 344
3.2.S.7.1 Stability Summary and Conclusions Submitted
3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment Submitted
3.2.S.7.3 Stability Data Submitted
Stability study completed up to 6 months at accelerated condition Viz. 25oC±2oC/ 60% ±5% RH
and study completed up to 60 months at long term condition Viz.5oC±3oC.
3.2.P DRUG PRODUCT
3.2.P.1
DESCRIPTION AND COMPOSITION OF THE DRUG PRODUCT Submitted
3. Unit composition with indication of the function of the inactive ingredient(s)
4. Formulation
Comments
3.2.P.2
PHARMACEUTICAL DEVELOPMENT
3.2.P.2.1 Components of the Drug Product
3.2.P.2.1.1 Drug Substance Submitted
3.2.P.2.1.2 Excipients Submitted
3.2.P.2.2 Drug Product
3.2.P.2.2.1 Formulation Development Submitted
Pharmaceutical Equivalence through Comparative Dissolution Profile
Submitted
3.2.P.2.2.2 Overages Not applicable
3.2.P.2.2.3 Physicochemical and Biological Properties Submitted
3.2.P.2.3 Manufacturing Process Development Submitted
3.2.P.2.4 Container Closure System Submitted
3.2.P.2.5 Microbiological Attributes Submitted
3.2.P.2.6 Compatibility Submitted
The firm has submitted following:
Stability of this product under various conditions has been monitored since compatibility study
was not performed. Results from stability studies proved that active ingredients and packaging
material are well suited, and do not exert any adverse impact on finished pharmaceutical
product performance.
3.2.P.3 MANUFACTURE
3.2.P.3.1 Manufacturer(s) Submitted
3. Name and full address(es) of the facility(ies)
4. Contact name, phone and fax numbers, email address
Comments
3.2.P.3.2 Batch formula Submitted
Largest intended commercial batch size
Comments
3.2.P.3.3 Description of manufacturing process and process controls Submitted
4. Description of the manufacturing process and facility
5. Master production batch record(s) for largest intended production runs
(no more than 10x pilot batch) with equipment specified
6. Master packaging records for intended marketing container(s)
Comments
3.2.P.3.4 Controls of critical steps and intermediates Submitted
Comments
3.2.P.3.5 Process validation and/or evaluation Submitted
3.2.P.4 CONTROL OF EXCIPIENTS
Minutes of 294th Meeting of Registration Board | 345
3.2.P.4.1 Specifications Submitted
3. Testing specifications (including identification and characterization)
4. Supplier’s COA (specifications and test results)
Comments
3.2.P.4.2 Analytical procedures Submitted
Comments
3.2.P.4.3 Validation of analytical procedures Submitted
Comments
3.2.P.4.4 Justification of specifications (as applicable) Submitted
3.2.P.4.5 Excipients of Human or Animal Origin Not applicable
3.2.P.4.6 Novel Excipients Not applicable
Comments
3.2.P.5 CONTROLS OF DRUG PRODUCT
3.2.P.5.1
Specification(s) Submitted
Comments
3.2.P.5.2
Analytical procedures Submitted
Comments
3.2.P.5.3
Validation of analytical procedures Not submitted
(if using Pharmacopoeial procedure, must provide verification of Pharmacopoeial
procedure)
You have not submitted validation of analytical procedures under control of drug
product. It is very important to submit the data as specified in 3.2.P.5.3 especially
where in-house method is developed.
3.2.P.5.4
Batch analysis Submitted
Certificates of Analysis for finished dosage form
Comments
3.2.P.5.5
Characterization of impurities Submitted
All potential degradation products should be listed in a tabular format
Comments
3.2.P.5.6
Justification of specifications Submitted
All potential degradation products should be listed in a tabular format
Comments
3.2.P.6 Reference Standards or Materials Not submitted
Comments
3.2.P.7 CONTAINER CLOSURE SYSTEM Submitted
5. Summary of container closure system
6. Component specifications and test data
7. Packaging configuration(s) and size(s)
8. Container/Closure Testing (recommended additional testing for all
plastic)
a. Solid orals: water permeation, light transmission
b. Liquids: leachables, extractables, light transmission
i. Injectables with rubber stoppers: extractables
Information in various sections from 3.2.P.5.3 to 3.2.P.5.6 as well as 3.2.P.6 of
module III is not submitted. Relevant information is required to be submitted.
Minutes of 294th Meeting of Registration Board | 346
3.2.P.8 STABILITY
3.2.P.8.1 Stability summary and conclusion (Finished Dosage Form) Submitted
Stability protocol submitted
Expiration dating period for marketed packaging
Expiration dating period for bulk packaging (if applicable)
Comments
3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment Submitted
Comments
3.2.P.8.3 Stability Submitted
The firm has submitted stability sheets for 6 months at accelerated conditions and 24
months at real time conditions for three batches of their already marketed product Es-
Loprot 40mg IV Injection. However, the firm has not submitted raw data sheets and
chromatograms.
Sr.
No.
Observations communicated Response of the applicant
1.
Identification of Signature(s) of authorized
persons, Incharge Production, Quality Control
and Incharge Quality Assurance is not submitted.
Submitted
2.
Quantitative composition of applied formulation
contains Mannitol as mentioned in 2.3.P.1 and
3.3.P.1. However, reference product in MHRA
does not mention such excipient. Justification /
Clarification is required and also the compatibility
studies of API with this excipient is required.
The firm has submitted revised formulation which
does not contain mannitol. Accordingly firm has
submitted BMR and formulation for
Esomeprazole 40mg injection. However, firm has
just submitted template for BMR which does not
contain actual formulation development.
3.
You have not submitted validation of analytical
procedures under control of drug product. It is
very important to submit the data as specified in
3.2.P.5.3 especially where in-house method is
developed.
Not submitted
4.
Information in various sections from 3.2.P.5.3 to
3.2.P.5.6 as well as 3.2.P.6 of module III is not
submitted. Relevant information is required to be
submitted.
The firm has submitted Batch Analyses,
Characterization of impurities and justification of
finished product specifications.
5.
You have not submitted supporting documents
like raw data sheets and chromatograms against
submitted stability summary sheets of applied
formulation.
The firm has not submitted chromatograms of
initial time point of applied formulation. The firm
has submitted the data of already marketed
product Es-Loprot 40mg IV Injection of M/s
NabiQasim Industries Pvt. Ltd. karachi.
6.
Commitments as specified in sections 1.5.15,
1.5.16, 1.5.17, 1.5.19 and protocols as specified in
sections 1.5.21, 1.5.22 of module I are required to
be submitted.
Submitted
Previous Decision: Registration Board deferred the case for following observations: (M-292)
Scientific justification for the relevance of previously submitted data in section 3.2.P against recently revised
master formulation.
Submission of validation of analytical procedures as specified in 3.2.P.5.3 of module III of CTD.
Submission of chromatograms and raw data sheets of three batches of stability study data of initial time and
details of reference standards and materials as specified in 3.2.P.6.
Minutes of 294th Meeting of Registration Board | 347
Evaluation by PEC:
As per information from NabiQasim (contract manufacturer), they have developed the formulation of
Esomeprazole 40mg Injection as per innovator without mannitol and conducted its 06 months stability
studies. Based on satisfactory stability data, BMR of actual product is developed.
03 sets of BMRs of developmental batches of Esomeprazole 40mg Injection with their stability data, raw
data sheets and chromatograms are submitted.
For validation of analytical procedures as specified in 3.2.P.5.3, the firm has submitted following
documents:
Method validation protocol
Method validation report
For reference standard, firm has submitted following justification:
“For the analysis of Esomeprazole in lyophilized injection, Reference standard of omeprazole is used as they
are isomer of each other and contain same formula. This practice was adopted from United states
Pharmacopoea, as they are also using Omeprazole as a reference standard for the analysis of Esomeprazole
Magnesium delayed release capsules.”
Decision: Registration Board after considering the panel inspection report of M/s Nabiqasim
Industries Pvt. Ltd., 17/24, Korangi industrial Area, Karachi for Esomax (Esomeprazole) 40mg
IV Injection applied by M/s Martin Dow Limited., Plot 37, Sector 19, Korangi Industrial Area,
Karachi, decided to approve registration of ESVIN INJECTION 40mg with Innovator’s
specifications by M/s Martin Dow Marker Limited, 7- Jail Road, Quetta.
Minutes of 294th Meeting of Registration Board | 348
Registration-I Section
Case No.01: Clarification Regarding Former Approval/Permission Letters Issued by the
then Ministry of Health
Director General Health Services, Punjab has requested to clarify whether a firm/
manufacturer can quote the product in larger packs to Provincial Governments against tenders. In
this regard, a copy of following letter No. F.3-4/94-Reg-II (M-109) dated 01-11-1994 issued by
the then Ministry of Health stating “Supply of Larger Packs to Provincial Governments against
Tenders” has also been provided:
As the above referred letter dates back to almost 25 years. However, the case has
been placed before the Board for deliberation regarding rationality/requirement of such
permission in current situation. Furthermore, guidance is also requested regarding authenticity of
all such former approvals/permissions which require confirmation from old record.
Decision: Registration Board deferred the case for further deliberation.
Minutes of 294th Meeting of Registration Board | 349
Case No.02: Cancellation of Registration of Liquid Infusions of M/s YAS Chemicals, Swabi
Having Volumes /Packing Other Than 100ml Glass Bottle.
Registration Board in 292nd meeting (held on 1st -2nd October, 2019) noted that the
panel inspection of M/s Yusaf Ali Shah Chemical Industries, Plot No.191, Street L-10 Gadoon
Amazai, Swabi was conducted on 20-12-2018 which transpired that the manufacturing facility
has capability of producing 100ml infusion in glass bottles/vials only. Therefore, Registration
Board decided to issue show cause notice for cancellation of registrations of Liquid Infusions
having volumes other than 100ml glass bottle.
In view of the above decision the firm has been issued show cause notice (dated
26-02-2020) with respect to their following products to comply with the decision of Registration
Board and submit a compliance report within 15 days. However, till to date no response has been
received.
Sr.No. Reg. No. Brand Name & Composition Pack Size
1. 016449 Steri-Sol Dextrose 5% + Sodium Chloride 0.9% Injection
Contains:-
Dextrose Monohydrate……………….5%
Sodium Chloride …………………….0.9%
500ml
1000ml
2. 016450 Steri-Sol Ringers Solution
Each 500ml contains:
Sodium Chloride …………………….4.3gm
Potassium Chloride …………….……0.15gm
Calcium Chloride ……………………0.24gm
500ml
3. 016451 Steri-Sol Dextrose 5% Injection
Contains:-
Dextrose Monohydrate ……………….5.5gm
500ml
1000ml
4. 016452 Steri-Sol Sodium Chloride 0.9% Injection
Each 100ml contains:
Sodium Chloride………………………0.9gm
1000ml
5. 016454 Steri-Sol Hartmanns Solution
Each 500ml contains:
Sodium Chloride…………..………....3gm
Potassium Chloride……………….…0.2gm
Calcium Chloride…………………...0.135gm
Sodium Lactate………………..…....2.65gm
500ml
6. 016455 Steri-Sol Dextrose 5% + Sodium Chloride 0.45% Injection
Each 100ml contains:-
Dextrose Monohydrate……………….5.5gm
Sodium Chloride………………….….0.45gm
500ml
7. 016456 Steri-Sol Darrows Solution
Each 100ml contains:-
Sodium Chloride……………..……..0.4gm
Potassium Chloride…………..……..0.26gm
Sodium Lactate……………….…….0.59gm
500ml
8. 016453 Steri-Sol Metronidazole 0.5% Injection
Each 100ml contains:
Metronidazole……………………....0.5gm
Sodium Chloride…………………....0.85gm
100ml
PVC Bag.
Decision: Registration Board advised to issue reminder to M/s Yusaf Ali Shah Chemical
Industries, Swabi in the subject case.
Minutes of 294th Meeting of Registration Board | 350
Import & Vet. I-II Section
Case No.01: Inspection Exemption of manufacturing facility on the basis of EudraGMDP
Registration Board in 275th meeting approved 21 reference regulatory authorities
(RRAs). Further, inspection abroad is exempted for both the product and facility of said RRAs.
The subject policy is already approved by the DRAP and policy Board. The RRAs inspection
exemption are as under:
Facility (dosage form manufacturing facility or whole production facility") approved by
regulatory authorities of US FDA, EU EMA, PMDA Japan, Australia TGA, Health
Canada, Switzerland or any of regulatory authority of former erstwhile Western Europe
(United Kingdom, Germany, France, Switzerland, Netherlands, Austria, Belgium,
Denmark, Finland, Sweden, Italy, Ireland, Luxemburg, Norway, Scotland and Spain) or
minimum three stringent regulatory bodies of former erstwhile Eastern Europe may be
exempted from inspection of manufacturing facility, irrespective of the fact that the
manufacturing unit is not located in these countries.
The product pre-qualified by the World Health Organization will also be exempted from
inspection of manufacturing units abroad.
A number of firms apply for inspection exemption of manufacturing facility abroad from EU EMA
as stated above on the basis of EudraGMP. The EudraGMDP database is the Community database
on manufacturing, import and wholesale-distribution authorisations, and good manufacturing-
practice (GMP) and good-distribution-practice (GDP) certificates.The EudraGMDP database is
maintained and operated by the EMA. Access to the general public is granted in order to enhance
availability of information related to the EMA mandate. The content of the database is provided
by the National Competent Authorities (NCA) of the European Economic Area (EEA).
EMA Agency role:
EMA coordinates inspections for human and veterinary medicines authorised under
the centralised procedure or in the context of a referral, on request from the Agency's Committee
for Medicinal Products for Human Use (CHMP) or Committee for Medicinal Products for
Veterinary Use (CVMP).
EMA does not conduct inspections itself but requests that the inspection be carried out by national
authorities in the EU Member States.
Inspections:
Authorities in the EU regularly inspect sites of companies within and outside the EU involved in
developing, manufacturing and distributing medicines intended for the EU market, to verify their
compliance with the relevant standards.
These inspections ensure the reliability and integrity of the data that support the authorisation of
medicines and their quality, safety and effectiveness once on the market.
An inspection may either be 'for cause', when it is triggered by a finding of possible non-
compliance with relevant standards, or 'routine', when inspections are carried out as part of
surveillance programme.
Inspections are conducted for authorised medicines and medicines that are currently being
evaluated for authorisation.
Minutes of 294th Meeting of Registration Board | 351
EudraGMDP database provides GMP status of reference and non-reference countries. Keeping in
view above the guidance is required from Registration Board for inspection exemption of
manufacturer abroad on EurdaGMP certificate base.
Decision: Registration Board considered decision of Policy Board regarding exemption
of inspection of manufacturer abroad wherein EU EMA has been granted
exemption from inspection. Accordingly, the Board deliberated that as
EudraGMDP database is maintained and operated by the EMA thus the
Board decided to exempt inspection of manufacturer if its GMP status is
available on EurdaGMP data base irrespective of the fact that the
manufacturing unit is not located in Reference Regulatory Authorities
/countries.
Case No.02: Request of M/s Glaxo Smith Kline Pakistan Limited, Karachi For Change of
local release site of Their Registed Product.
M/s Glaxo Smith Kline Pakistan Limited, Karachichange of manufacturing site of their following
already registered products approved in 292nd as per details given below: -
S.
No
Reg.
No.
Name & Composition
(as per approval)
Existing approved Site
Manufacturing Site
(as per approval)
New approved site / Manufacturer
/ MAH (as per COPP)
1. 027381 Seretide Evohaler 25/50mcg.
Each actuation contains:
Salmeterol Xinafoate 36.3ug
Fluticasone Propionate 50ug
M/s Glaxo
SmithKline Australia
Pty Limited,
Australia.
Manufacturer
Glaxo Wellcome Production Zone
Industrielle No.2, 23 rue Lavoisier
27000 Evreux-France.
Marketing Authorization Holder:
Laboratoire GlaxoSmithKline 23 rue
Francois Jacob 92500 Rueil-
Malmaison-France.
2. 027382 Seretide Evohaler 25/125mcg.
Each actuation contains:
Salmeterol Xinafoate 36.3ug
Fluticasone Propionate 125ug
-do- -do-
3. 027383 Seretide Evohaler 25/250mcg.
Each actuation contains:
Salmeterol Xinafoate 36.3ug
Fluticasone Propionate 250ug
-do- -do-
The firm has submitted the following supporting documents: -
a) Fee of Rs.300,000/- for above three products.
b) Application on Form-5A and Form-5F.
c) Copy of initial registration letter & Post Registration renewal trail.
d) Original & legalized COPP.
e) Site master file for new manufacturing site.
f) Undertakings that provided information are correct.
Decision of 292nd meeting of Registration Board:
Registration Board approved the above changes in respect of registered products Seretide Evohaler
25/50mcg (Reg.No. 027381), Seretide Evohaler 25/125mcg (Reg.No. 027382) and Seretide
Minutes of 294th Meeting of Registration Board | 352
Evohaler 25/250mcg (Reg.No. 027383) subject to policy for imported finished drug registration.
Other terms and conditions remain the same.
During processing of post registration variation letter it was observed that Drug Sales License of
applicant is not valid. Now, applicant submitted Rs.15,000/- fee and apply for change of applicant
site along with copy of old and new Drug Sales License.
Approved DSL name & address Applied DSL name & address
GlaxosmithKline Pakistan 35-Dockyyard
Road, west wharf Karachi
Valid till 18-Aug-2017
GlaxosmithKline Pakistan Limited F-268
S.I.T.E Karachi
Valid till 19-Feb-2022
Decision: Keeping in view the valid Drug Sale License, Registration Board approved the
change in address of importer of above products from GlaxosmithKline
Pakistan 35-Dockyyard Road, west wharf Karachi to GlaxosmithKline
Pakistan Limited F-268 S.I.T.E Karachi. Approval letter shall be issued after
storage facility verification of new site.
Minutes of 294th Meeting of Registration Board | 353
Post Registration-I Section
Case No.01: Registration of Drug(s) of M/s Swiss Pharmaceuticals (Pvt) Ltd, A/159,
S.I.T.E Super Highway, Karachi for Export Purpose Only.
Firm has applied for registration of drug(s) only for export purpose as per following details:
Requirements As Per SOP Submitted Documents
Application on Form-5/ Form 5-D with required fee as per
relevant SRO.
Form5D submitted
Copy of DML (Renewal status) along with approval of
relevant sections verified by licensing Division or
inspection report for renewal of DML before 2005.
Copy of DML provided
Approval of relevant section verified from DML
renewal inspection report dated 30.12.2014.
GMP Status. Copy of Inspection report/GMP certificate. GMP status verified from GMP inspection report
dated 18.10.2018
Undertakings that the applied product is exclusively for
export purpose and the proposed names/ label/ colour do
not resemble with already registered brands in importing
country.
Provided
Detail of the products is given below:
Sr.# Name of Drug(s) with composition Generic/RRA Status Diary No. date & Remarks.
I II III IV
1. Oragel adult 16+ Gel
Each 100gm contains:
Choline Salicylate …….8.7% w/w
Cetalkonium Chloride …..0.01% w/w
Lidocaine………………...0.2 %w/w
Me too status/ RRA
status not available
Purchase order from
Kenya
Dy. No1413/ 2020-PE&R-
(EFD) 06-04-2020.
Rs.50000/- dated 18-03-2020
Decision: Regitration Board deferred for further deliberation.
Case No. 02: Registration of Drug(s) of M/s Sigma Pharma International (Pvt) Ltd plot
No.E-50, NWIZ Port Qasim, Karachi for Export Purpose Only.
Firm has applied for registration of drug(s) only for export purpose as per following details:
Requirements As Per SOP Submitted Documents
Application on Form-5/ Form 5-D with required fee as per
relevant SRO.
Form5D submitted
Copy of DML (Renewal status) along with approval of
relevant sections verified by Licensing Division or
inspection report for renewal of DML before 2005.
Copy of DML provided
Approval of relevant section verified from CLB
letter No. F.6-6/14-Lic(M-237) dated 17-10-2014
GMP Status. Copy of Inspection report/GMP certificate. GMP status verified from GMP inspection dated
18.09.2018
Undertakings that the applied product is exclusively for
export purpose and the proposed names/ label/ colour do
not resemble with already registered brands in importing
country.
Provided
Minutes of 294th Meeting of Registration Board | 354
Detail of the product is given below:
Sr.# Name of Drug(s) with composition Generic/RRA Status Diary No. date & Remarks.
I II III IV
1. Preminbay Capsule
Each capsule contains:
Pregabalin….75mg
Methylcobalamine…500mcg
Me too status/ RRA status
not available
Purchase order from
cambodia
Dy.No.1383 /19-EFD (PE&R)
dated 09-02-2020
Rs.50000/- dated 02-03-2020
Decision: Registration Board approved above mentioned product of Sigma Pharma
International (Pvt) Ltd plot No.E-50, NWIZ Port Qasim, Karachi for export
registration. Since applied formulation is neither registered for local use nor
approved by any RRA (as adopted by Registration Board in 275th meeting)
hence manufacturer and importing country shall be responsible for safety,
efficacy and quality of drug product.
Case No. 03: Registration of Drug(s) of M/s English Pharmaceuticals Industries Link
Kattar Band Road, Thokar Niaz Baig, Multan Road, Lahore for Export
Purpose Only.
Firm has applied for registration of drug(s) only for export purpose as per following details:
Requirements As Per SOP Submitted Documents
Application on Form-5/ Form 5-D with required fee as per
relevant SRO.
Form5D submitted
Copy of DML (Renewal status) along with approval of
relevant sections verified by Licensing Division or
inspection report for renewal of DML before 2005.
Copy of DML provided
Approval of relevant section verified from CLB
letter No. F.1-11/92-Lic(Vol-III) dated 09-03-2015
GMP Status. Copy of Inspection report/GMP certificate. GMP status verified from GMP certificate based on
inspection dated 17th and 18th January 2019
Undertakings that the applied product is exclusively for
export purpose and the proposed names/ label/ colour do not
resemble with already registered brands in importing
country.
Provided
Detail of the product is given below:
Sr.# Name of Drug(s) with composition Generic/RRA
Status
Diary No. date & Remarks.
I II III IV
1. Essentiallite-H Injection
Each 5ml ampoule contains:
Phosphatidylcholine……….250mg
Benzyl Alcohol ……………45mg
Deoxycholic Acid…………126.5mg
Riboflavin(vitamin B2)……0.5mg
Sodium chloride……………12mg
Sodium Hydroxide………...13.40mg
Me too status/
RRA status
not available
Purchase
order for
Uzbekistan
Dy.No.1414 /19-EFD (PE&R) dated 07-04-2020
Rs.20,000/- dated 01-01-2020
Rs.30,000/- dated 11-02-2020
Clinical use: Use for acute and chronic hepatitis
, cirrhosis, necrosis of liver cells, fatty
degeneration of liver.
2. Essentiallite Forte Capsule
Each capsule contain;
Phosphatidylcholine…..300mg
VitaminB1(Thiamine Mononitrate)
…………………..6mg
Me too status/
RRA status
not available
Dy.No.1415 /19-EFD (PE&R) dated 07-04-2020
Rs.20,000/- dated 01-01-2020
Rs.30,000/- dated 11-02-2020
Clinical use: use to relieve symptoms of liver
damage
Minutes of 294th Meeting of Registration Board | 355
Vitamin B2(Riboflavin)…….….6mg
Vitamin B3(Nicotinamide)…….6mg
Vitamin B6 (pyridoxine HCl)….6mg
Vitamin B12 (cynocoblamine)…60mcg
Vitamin E (Tocopheral Acetate)...6mg
Purchase
order for
Uzbekistan
Decision: Registration Board approved above mentioned product of M/s English
Pharmaceuticals Industries Link Kattar Band Road, Thokar Niaz Baig,
Multan Road, Lahore for export registration. Since applied formulation is
neither registered for local use nor approved by any RRA (as adopted by
Registration Board in 275th meeting) hence manufacturer and importing
country shall be responsible for safety, efficacy and quality of drug product.
Case No. 04: Registration of Drug(s) of M/s Ophth Pharma (Pvt) Ltd. Plot No. 241, Sector
24, Korangi Industrial Area, Karachi for Export Purpose Only.
Firm has applied for registration of drug(s) only for export purpose as per following details:
Requirements As Per SOP Submitted Documents
Application on Form-5/ Form 5-D with required fee as per
relevant SRO.
Form5D submitted
Copy of DML (Renewal status) along with approval of
relevant sections verified by Licensing Division or
inspection report for renewal of DML before 2005.
Copy of DML provided
Approval of relevant section verified from Panel
inspection for renewal of DML dated 04-08-2016.
GMP Status. Copy of Inspection report/GMP certificate. GMP status verified from GMP Inspection dated 27-
09-2019
Undertakings that the applied product is exclusively for
export purpose and the proposed names/ label/ colour do
not resemble with already registered brands in importing
country.
Provided
Detail of the product is given below:
Sr.# Name of Drug(s) with composition Generic/RRA Status Diary No. date & Remarks.
I II III IV
1. Ophth Atropine 0.01% Eye Drops
Each ml contains:
Atropine Sulphate…0.1mg
Me too status/ RRA status
not available
Purchase order for
Afghanistan
Dy.No.1416 /19-EFD (PE&R)
dated 07-4-2020
Rs.20,000/- dated 20-11-2019
Rs.30,000/- dated 08-01-2020
Decision: Registration Board approved above mentioned product of M/s Ophth
Pharma (Pvt) Ltd. Plot No. 241, Sector 24, Korangi Industrial Area, Karachi
for export registration. Since applied formulation is neither registered for
local use nor approved by any RRA (as adopted by Registration Board in
275th meeting) hence manufacturer and importing country shall be
responsible for safety, efficacy and quality of drug product
Minutes of 294th Meeting of Registration Board | 356
Item No. III Division of Biological Evaluation & Research
Sr. No. Details of application No. of Cases
A Miscellaneous cases 01
Total 01
Sr. No. Assistant Director Designated No. No. of Cases
a. Mr. M. Zubair Masood AD-III 01
A: Miscellaneous Cases
Case No.01: Exemption from the Drugs Labelling & Packaging Rules, 1986 for Actemra
(Tocilizumab) 200mg Vial (Reg No. 083135) at the time of import applied by
M/s Roche Pakistan Limited, Karachi.
M/s Roche Pakistan Limited, Karachi applied for the exemption from the Drugs Labelling &
Packaging Rules, 1986 at the time of import for their already registered product Actemra 200mg
(Reg. No. 083135). The firm submitted that we all are informed that there is no targeted drug for
COVID-19 and it is only being treated symptomatically and supportively. The “Clinical
Management Guidelines for Covid-19 Infections” (issued by NHSRC, Govt. of Pakistan) has
mentioned one of their registered products, Actemra (tocilizumab), as an important drugs for
COVID-19 management, which has exponentially increased its demand and they have been
receiving the requests for the said drug from miscellaneous medical institutions and hospitals (pf
which some notable are SIUT, AKUH and DOW) for the urgent supply of it.
Since, the said product is imported from their principal F. Hoffmann-La Roche Ltd., Basel,
Switzerland and due to high demand of this product from all over the world, it will take us at least
six months to import the shipment on local (Pakistan make-up) label, which includes Urdu text,
local MRP and local registration number. The shipment will be received in parts.
The firm has submitted the following documents:
a. Fee challan of Rs. 5000/-
b. Copy of clinical management guidelines for COVID-19 infections issued by MNHSR&C
which indicates the following:
“These medications have considerable adverse effects, have limited available and unclear
efficacy. Consultation with an Infectious Disease Specialist is mandatory prior to
prescribing.”
c. Prints of emails from Agha Khan University and SIUT indicating demand of Actemra for
COVID-19.
d. Copies of invoices of Agha Khan Hospital, Indus Hospital and SIUT for Actemra.
Minutes of 294th Meeting of Registration Board | 357
In this context, it is submitted that the aforementioned product has already been registered
on 28-04-2017 as per following details:
Reg.No. Name of Manufacturer Brand Name & Composition Pack Size
083135 M/s Utsunomiya Plant of
Chugai Pharma Manufacturing
Co., Ltd., 16-3, Kiyohara
Kogyodanchi, Utsunomiya-
city, Tochigi, Japan
Actemra 200mg
(Concentrate for Solution for
Infusion)
Each vial(4ml) contains:
Tocilizumab (Genetical
Recombination)…….80 mg
1’s Vial
Prescribing information available on official website of FDA indicates following indications for
above product (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125276s114lbl.pdf):
i. Rheumatoid Arthritis (RA)
ii. Giant Cell Arteritis (GCA)
iii. Polyarticular Juvenile Idiopathic Arthritis (PJIA)
iv. Systemic Juvenile Idiopathic Arthritis (SJIA)
v. Cytokine Release Syndrome (CRS)
Moreover, the online available news show that Roche has announced that the US Food and Drug
Administration (FDA) has formally approved its phase 3 trial of Actemra in severely ill COVID-
19 patients, who have been hospitalised with pneumonia. The trial – named COVACTA – will
recruit around 330 patients around the world, with an expected start date sometime in early April.
The primary and secondary endpoints will include assessing clinical status, mortality, mechanical
ventilation and intensive care unit variables in the patient population. Despite a number of clinical
trials evaluating Actemra already ongoing across the world, Genentech has maintained that the
COVACTA study is pivotal because there are still no well-controlled studies and limited published
evidence on the safety or efficacy of the drug in COVID-19.
(https://www.pmlive.com/pharma_news/fda_approves_roches_actemra_covid-19_trial_1329887)
The firm has requested to grant them exemption from the Drugs Labelling & Packaging Rules,
1986 for Actemra (Tocilizumab) 200mg Vial (Reg No. 083135) at the time of import.
Decision: Registration Board deliberated the case in light of prevailing COVID-19
emergency situation and considered Clinical Management Guidelines for
COVID-19 Infections issued by M/o NHSR&C, requirements of Actemra
200mg by leading medical institutions of the country (AKUH, SIUT, Indus,
HMC, DOW etc) for management of their COVID-19 patients and Rule 3 of
Drugs (Labeling & Packing) Rules, 1986 and decided as under:
a. Acceded to request of the firm for import of registered Actemra 200mg, Reg.
No. 083135 in Standard Export Packs.
b. The firm shall make necessary arrangement for local printing of MRP and
Registration Number at least on secondary packing before sale of drug, at any
licensed premises having. Firm shall be responsible for providing requisite
cold chain facility during local printing process under supervision of relevant
experts of manufacturing and Quality Assurance. Complete batch processing
record shall be maintained for aforementioned process.
c. Actemra 200mg, Reg. No. 083135 shall be supplied only to medical institutions
for use under strict medical supervision of relevant experts / Registered
Minutes of 294th Meeting of Registration Board | 358
Medical Practitioner and shall not be sold either to retail pharmacies or whole
sale market.
d. Complete import, sale / supply and printing record shall be maintained and
will be provided if required by DRAP.
e. This permission shall be valid for three (03) months only. During this period,
M/s Roche shall make efforts for future import of finished product as per
requirements of Drugs (Labeling & Packing) Rules, 1986.
Case No.02: Change in address of Importer and renewal of already registered drugs
applied by M/s Marush Pvt. Ltd., Lahore approved in 292nd meeting of
Registration Board.
Requests of M/s Marush Pvt. Ltd., Lahore for change in address of importer and grant of
renewal of registered drugs were considered in 292nd meeting of Registration Board wherein the
Board decided as follows:
“Registration Board granted the renewal of above products as per following details subject
to submit an undertaking on notarized stamp paper that the valid authorization of below
mentioned products in their name is true & correct, nothing has been concealed and that
if at any stage any discrepancy / misinformation is detected / observed the firm/ company
will be held responsible as per relevant laws:……..”
AND
“Keeping in view the valid Drug Sale License; Registration Board approved the change of
address of importer from M/s Marush Pvt. Ltd., Khoti No. 123-K First Floor, Model Town
Lahore to M/s Marush Pvt. Ltd., 117-A, Ahmad Block, New Garden Town Lahore for above
products subject to cold storage facility verification of their godown.”
During processing the cases for issuance of letters, the comments of QA< Division were
sought regarding the pending inquiries against the firm and following response was received:
“It is submitted that the Central Licensing Board in its 262nd meeting has granted the permission
for registration of 03 FIRs against following accused persons, 1. M/s Marush International Pvt.
Ltd., Karachi 2. Muzamil Husain Shah 3. Muhammad Usman Ali Shah to Area FID, Karachi.
That the FID Karachi vide letter No. SAA.F. 1-1/2019-FID-V(K) dated 03rd December,
2019 informed that he visited the office of FIA and met with the investigation offiocer Mr. Abdul
Jabbar Mendhro to seek the current status, the inspector verbally informed that the accused
persons have already been penalized for issuing forged/ fake documents and the same accused
persons cannot be penalized with similar allegations due to “double jeopardy”. As per letter of
area FID, no written communication has been made by inspector FIA, Karachi which is required
to be verified after seeking legal opinion in this regard.
Furthermore, the Central Licensing Board in its 263rd meeting has granted permi8ssionms
for registration of 03 FIRs against following accused persons, 1. Syed Muzamil Husain Shah 2.
Syed Usman Ali Shah 3. Muhammad Ziauddin 4. Ansar Mehmood to Area FID, Karachi.
That Assistant Director/ Ex-area FID, Lahore vide letter 9595/2019-DRAP(AD-PEC)
dated 12-07-2019 informed that FIR No. 158/2018 has been registered in FIA, Lahore against the
Minutes of 294th Meeting of Registration Board | 359
following accused persons, 1. Syed Muzamil Husain Shah 2. Syed Usman Ali Shah 3. Muhammad
Ziauddin.”
After the above comments from QA< Division, it was decided to take the opinion of Legal
Affairs Division whether the approval letters should be issued or not. In response, the legal Affairs
Division submitted the following:
“It is submitted that there are many inquiries pending against the firm as mentioned by QA<
Division. Furthermore, for the purpose of issue of summons/ warrants or process by the court or
Investigation agency, the already provided address will be used. Therefore, the Division is opined
that the concerned Division may not process the case for change in address of importer while the
division may process the case of renewal in accordance with the law.”
In this context, it is submitted that while processing the case for issuance of renewal
certificates on old DSL address it was observed that the old DSL is no more valid. Meanwhile, the
firm informed that the case no. 158/2018 registered by FID Lahore against M/s Marush Pvt. Ltd.
Lahore has been closed and same information has already been forwarded to Additional Director,
DRAP Lahore. The firm requested to issue them the pending registration letters along with renewal
certificates and approval of change in address of importer.
The case was then referred to QA< Division for the verification of above claim of the
firm and Director QA< advised that as the case of M/s Marush Pvt. Ltd., is long pending with
various aspects requiring clarifications. It would be appropriate if the whole case with all
comprehensive detail be put up before Registration Board for further disposal/ necessary action.
Decision: Deputy Director, Legal Affairs Division apprised the Board that as the address
of importer has already been changed on DSL therefore, approval letters may
be issued on new address and the concerned inquiry agencies may be informed
regarding said change. Keeping in view the said opinion, Registration Board
advised DBER to issue pending registrations and renewal certificates along
with approval of change in address of importer to the firm on new address as
already approved in previous Registration Board meetings. Registration
Board further advised to inform the concerned inquiry agencies regarding the
change in address of the firm for their future communications.
Minutes of 294th Meeting of Registration Board | 360
Item No. IV Division of Quality Assurance & Laboratory Testing
Case No. 01: DRAP REVIEWING DRUGS CONTAINING RANITIDINE
FOLLOWING FDA / EMA ALERTS ON DETECTION OF
PROBABLE CARCINOGENIC IMPURITY.
In a letter received on 16-09-2019 with subject “NOTIFICATION OF GLOBAL REVIEW
INTO RANITIDINE FORMULATIONS BY GLAXOSMITHKLINE (GSK) AND
ASSOCIATED”, Dr. Gohar Nayab Khan, Director (Regulatory Affairs) GSK Pakistan Limited,
35-Dockyard Road, West Wharf, Karachi-74000, Pakistan informed as under;
“On 29 August, 2019, we were notified by Swissmedic’s Official Medicines
Control Laboratory (Swissmedic OMCL) about the initiation of a review procedure
following the low-level detection of N-nitrosodimethyamine (NDMA) impurity in
one batch of Zantac injection solution 50mg product/5ml, batch 669A. The value of
NDMA found was in the 0.3ppm range relative to the active substance.
The product is manufactured and packaged at GSK’s site in Pharma, Italy,
using API produced by the supplier, Dr. Reddy’s Laboratories Ltd., India (DRL).
We have provided the information requested by Swiss medic and suspended
the distribution of Zantac injection solution 50mg product/5ml batches in
Switzerland as a precautionary action, based on their instructions and pending our
own investigations.
On 12 September 2019, GSK was also notified by Health Sciences
Authority (HSA), the Singapore regulatory authority, that it had tested all locally
available ranitidine products for the presence of nitrosomine compounds and
found most of the Zantac products contained NDMA. Consequently,
HSAinstructed GSK to suspend the whole supply of the above products and conduct
a Class 2 retail level recall of the Zantac products.
Based on the instructions received from the HSA and as a precautionary
action, GSK has made a decision to suspend the release and supply of all Zantac
products to the Singapore market and to implement the Class 2 retail level recall
of the Zantac products which will be initiated on 16 September, 2019.
GSK is continuing with investigations into the potential source of the
NDMA. These investigations include continued engagement with the API suppliers.
GSK have engaged with external laboratories to conduct tests on API and
finished product batches of Zantac IV. Test results are expected by the end of
September 2019. The testing is being extended to include batches of tablets and
potentially other dose forms if required.
Based on information received to date and correspondence with the
regulatory authorities, GSK has made the decision to suspend the release and
supply for all dose forms of Zantac products to all markets, including Pakistan,
as a precautionary action pending the outcome of the ongoing tests and
investigations.
GSK is committed to supplying high-quality products to patients and we are
actively working with the regulatory authorities to address their concerns.
Minutes of 294th Meeting of Registration Board | 361
In Pakistan, Zantac products (Tablets 150mg & 300mg & Injection 50mg/5mL)
are locally manufactured and not imported/supplied from overseas sites.”
03. Following are the international scenarios on the subject matter:
Source Brief contents
THE
HINDU-
BusinessLine
Some countries in the European Union are recalling ranitidine containing an
active ingredient made by India-based manufacturer, Saraca Laboratories Ltd,
said Germany’s Federal Institute for Drugs and Medical Devices in a statement
HBW insight Ranitidine Recalls Begin In Europe As Regulators Take Action:
“[…] Germany, Switzerland and Austria are the first European countries to
initiate recalls of ranitidine-based drugs after tests showed that certain products
contained N-nitrosodimethylamine, a probable human carcinogen.[…]
THE
HINDU-
BusinessLine
Europe, Canada start recall of Zantac drug versions after carcinogen scare:
FDA –
MedWatch
Safety alert
The FDA safety information and Adverse Event Reporting Program alert on
Zantac (Ranitidine) Safety information – NDMA Found in Samples of Some
Ranitidine Medicines.
EMA communication vide no. EMA/503622/2019 dated 13.09.2019 bearing title
“EMA to review ranitidine medicines following detection of NDMA”
In response to the mentioned scenario, a nationwide recall alert was issued vide letter F. No. 13-
1733/2019-QC dated 23-09-2019 with the approval of Chief Executive Officer, DRAP. In greater
public interest and in order to protect patients from probable risk associated with detection of low
levels of NDMA in Ranitidine containing products as per alert of FDA & EMA, the manufacturers
of Ranitidine containing products were advised that following regulatory actions shall be initiated
on immediate basis;
i. Suspension of production for all dosage forms of ranitidine containing drugs till further
orders;
ii. Stoppage of release/distribution of all dosage forms of ranitidine containing drugs till
further orders; and
iii. Stoppage of sale/supply/utilization of all dosage forms of ranitidine containing drugs till
further orders.
That Mr. Nawaz Ahmed, Secretary General/Executive Director of PPMA vide letter No.
PPMA/CEO/DRAP/2019/110 dated 26th September 2019 regarding the matter of Ranitidine
HCL and the Detection of NDMA-A Carcinogenic Impurity addressed the CEO, DRAP Islamabad
wherein informed & reproduced as under:-
“With reference to the subject cited above news circulated by the US Media
the initiation of the probe by the USFDA on Ranitidine HCL containing medication
and the subsequent Letter No.12208/2019-DRAP (L-VII), dated September 2019
from the office of Ms. Aisha Irfan FID DRAP Lahore titled recalled alert under the
direction of the Directorate of Quality Assurance and Lab Testing letter No.01-
20/2019-FID-I (K) dated 23rd September 2019 from the office of Dr. Najam Us-
Saquib FID DRAP Karachi Letter Dy.No.40/2019-FID-III dated 23rd September
2019 from the office of Hasan Afzal FID III DRAP Islamabad and letter No.F.13-
173/2019-QC from the office of Arslan Tariq AD QC- I DRAP Islamabad kindly
note that we would like to bring to your knowledge that PPMA has discussed the
matter amongst its member firms and after studying the global information
Minutes of 294th Meeting of Registration Board | 362
available and a through concrete discussion the PPMA members have unanimously
arrived to the conclusion that it is too early for the Drug Regulatory of Pakistan
(DRAP) to issue a Recall Alert.
2. Before stating our point of view we would like to inform your office that
Ranitidine HCL containing medication is commonly used in treatment of peptic
ulcer disease gastroesophageal reflux disease, and Zollinger-Ellison syndrome.
Ranitidine HCL is part of not only the NEML 2018 issued by DRAP but is also
included in the WHO Model List of Essential Medicine 2019.
3. The Ground for the conclusion stated in Para 1 lies in the facts that though
the USFDA has initiated a probe on the Ranitidine HCL containing medication it
has not directed the Manufactures for a recall and neither have the health officials
of the USFDA directed the patients to stop medication. The only Recall reported
was voluntary Recall.
It may also be noted that the UAE Ministry of Health & Prevention via Circular
No. (2) 2019 dated 23rd September 2019 has clearly mentioned that the said
Circular is not a Recall Circular and the Existing Stocks of Ranitidine products
currently available in the Pharmacies or at Retails stores may continue to be sold.
4. Furthermore, it may also be mentioned that NDMA is found in portable water
meat and certain foods consumed by us in minute quantities.
For the same it is concluded that consuming large quantities of Ranitidine HCL
containing medication may lead to the higher risks of Carcinogenic effect not at
the prescribed doses and dosages.
5. The summary of the Toxicology assessment ICH M7 aligned limits of NDMA in
Drug products, is mentioned below in Tabular Form.
According to the below information 1 out of 100,000 theoretical risk of cancer is
present if 0.0959mcg/day or 95.9ng/day NDMA is consumed for a period of 70
years. This is a worst case scenario.
The class of medication that Ranitidine HCL belongs to is not prescribed as part of
a long duration of therapy.
Number of
doses
1 7 31 84 365 2190 3285 3650 7300 25550
Duration 1 day 7 days 1
Month
12
week
1
year
6
years
9
years
10
years
20
years
70
years
NDMA
Daily intake
mcg/day
2450.24 350.035 79.04 29.17 6.713 1.12 0.746 0.671 0.336 0.0959
Table 1 :- ICH M7 aligned less that lifetime limits of NDMA for drug products
associated with a theoretical 1 in 100,000 excess lifetime risk of cancer.
6. For the same we request that the Drug Regulatory Authority of Pakistan
(DRAP) taking a decision on technical grounds and in light of the actions taken by
the USFDA and other Global Regulatory Authorities may take the following steps.
i. Withdraw the Recall Alert.
ii. Directions may be given to the manufacturers of Ranitidine HCL containing
medication to immediately initiate the testing of the Ranitidine HCL API
irrespective of the source of the API and also initiate the testing of all the
Minutes of 294th Meeting of Registration Board | 363
batches of the Finished product marketed which are within the labeled shelf
life of the product and currently manufactured and planned for marketing
and confirm that the results are within the USFDA stated acceptable limits
of 0.0959mcg/day or 95.9ng/day of NDMA.
The batches with values within the acceptable limit may be un seized and
permitted to be distributed sold freely and the batches that are out of
specifications may not only be reported of Drug Regulatory Authority of Pakistan
DRAP but the batches may also be voluntarily recalled.”
That in their update issued on 04-12-2019, Food and Drug Administration, USA (US FDA)
stated as under; (https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-
announcements-ndma-zantac-ranitidine)
“Update [12/4/2019] Over the past several weeks, FDA has communicated about
the detection of an impurity known as N-nitrosodimethylamine (NDMA) in common
heartburn medications (ranitidine, commonly known as Zantac, and nizatidine)
available over the counter or by prescription. We have launched an investigation
to understand the cause of this impurity in these drugs and to provide information
for patients and consumers who take them. As part of this investigation, we have
asked manufacturers to conduct their own laboratory testing to examine levels of
NDMA in ranitidine and nizatidine and to send us samples to be tested by our
scientists.
Today, we are announcing that we have asked manufacturers of ranitidine and
nizatidine products to expand their testing for NDMA to include all lots of the
medication before making them available to consumers. If testing shows NDMA
above the acceptable daily intake limit (96 nanograms per day or 0.32 parts per
million for ranitidine), the manufacturer must inform the agency and should not
release the lot for consumer use [………].
Proceeding and Decision of the 293rd meeting of Registration Board.
The board deliberated about the identification of NDMA a carcinogenic impurity in Ranitidine
containing products which poses threat to the consumers if found above the prescribed limits.
Keeping in view risk the Board decided as under:
i. That every manufacturer holding registration of ranitidine containing products are
under obligation of law to provide testing facilities of this impurity for every
consignment (API and finished) imported and brought into Pakistan. The consignments
(API and finished) should be accompanied with the certificates of analysis by the
manufacturers. Meanwhile the manufacturers/importers may temporarily avail testing
facilities of the any public sector institutions till the establishment of their own facility
for testing of ranitidine API and finished Pharmaceutical Products. However sampling
will be done by the area AD, DRAP and meanwhile the consignment (API and
finished) will be released with the restriction that it could only be used if it has qualified
requisite tests from the public institutions/testing laboratories and the certificate has
been endorsed by the DRAP.
ii. The Board further decided to allow resumption of production of ranitidine containing
products, with direction that manufacturers/registration holders of ranitidine
Minutes of 294th Meeting of Registration Board | 364
containing products shall expand their testing for NDMA to include all lots of the
medication before making them available to consumers.
iii. If testing shows NDMA above the acceptable daily intake limit (96 nanograms per day
or 0.32 parts per million for ranitidine) both for API and finished products, the
manufacturer must inform the DRAP and should not release the lot of ranitidine API
for production and finished Pharmaceutical Products for consumer use. Board
constituted following panel for destruction of such batches of ranitidine containing
products:
i. The Additional Director.
ii. Area Federal Inspector of Drugs.
iii. Assistant Director I&E.
Any two of the above with the permission of Additional Director.
iii. The above mentioned panel will make coordination with the respective
manufacturer for the destruction of stocks and will prepare destruction
certificates for the consideration of the Drug Registration board. It shall be
ensured that destruction /incineration is conducted in the presence of panels
and incineration certificates from the environment protection agency are also
accompanied with the panel report.
iv. Board further directed to bring details of seized and/or order not to dispose of stocks
of ranitidine API as well as finished products by FIDs through Pakistan to decide its
fate.
Meanwhile, USFDA issued a press release dated 1st April, 2020 and requests removal of all
ranitidine products (Zantac) from the market, the contents are reproduced as under:
“FDA Requests Removal of All Ranitidine Products (Zantac) from the Market
FDA Advises Consumers, Patients and Health Care Professionals After New
FDA Studies Show Risk to Public Health
The U.S. Food and Drug Administration today announced it is requesting
manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine
drugs from the market immediately. This is the latest step in an
ongoing investigation of a contaminant known as N-Nitrosodimethylamine
(NDMA) in ranitidine medications (commonly known by the brand name Zantac).
The agency has determined that the impurity in some ranitidine products increases
over time and when stored at higher than room temperatures and may result in
consumer exposure to unacceptable levels of this impurity. As a result of this
immediate market withdrawal request, ranitidine products will not be available
for new or existing prescriptions or OTC use in the U.S.
“The FDA is committed to ensuring that the medicines Americans take are safe
and effective. We make every effort to investigate potential health risks and
provide our recommendations to the public based on the best available science.
We didn’t observe unacceptable levels of NDMA in many of the samples that we
tested. However, since we don’t know how or for how long the product might
have been stored, we decided that it should not be available to consumers and
patients unless its quality can be assured,” said Janet Woodcock, M.D., director
of the FDA’s Center for Drug Evaluation and Research. “The FDA will
Minutes of 294th Meeting of Registration Board | 365
continue our efforts to ensure impurities in other drugs do not exceed acceptable
limits so that patients can continue taking medicines without concern.”
NDMA is a probable human carcinogen (a substance that could cause cancer). In
the summer of 2019, the FDA became aware of independent laboratory testing
that found NDMA in ranitidine. Low levels of NDMA are commonly ingested in
the diet, for example NDMA is present in foods and in water. These low levels
would not be expected to lead to an increase in the risk of cancer. However,
sustained higher levels of exposure may increase the risk of cancer in humans. The
FDA conducted thorough laboratory tests and found NDMA in ranitidine at low
levels. At the time, the agency did not have enough scientific evidence to
recommend whether individuals should continue or stop taking ranitidine
medicines, and continued its investigation and warned the public in September
2019 of the potential risks and to consider alternative OTC and prescription
treatments.
New FDA testing and evaluation prompted by information from third-party
laboratories confirmed that NDMA levels increase in ranitidine even under
normal storage conditions, and NDMA has been found to increase significantly in
samples stored at higher temperatures, including temperatures the product may
be exposed to during distribution and handling by consumers. The testing also
showed that the older a ranitidine product is, or the longer the length of time since
it was manufactured, the greater the level of NDMA. These conditions may raise
the level of NDMA in the ranitidine product above the acceptable daily intake
limit.
With today’s announcement, the FDA is sending letters to all manufacturers of
ranitidine requesting they withdraw their products from the market. The FDA is
also advising consumers taking OTC ranitidine to stop taking any tablets or liquid
they currently have, dispose of them properly and not buy more; for those who
wish to continue treating their condition, they should consider using other
approved OTC products. Patients taking prescription ranitidine should speak with
their health care professional about other treatment options before stopping the
medicine, as there are multiple drugs approved for the same or similar uses as
ranitidine that do not carry the same risks from NDMA. To date, the FDA’s testing
has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole
(Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).
In light of the current COVID-19 pandemic, the FDA recommends patients and
consumers not take their medicines to a drug take-back location but follow the
specific disposal instructions in the medication guide or package insert or follow
the agency’s recommended steps, which include ways to safely dispose of these
medications at home.
Minutes of 294th Meeting of Registration Board | 366
The FDA continues its ongoing review, surveillance, compliance and
pharmaceutical quality efforts across every product area, and will continue to
work with drug manufacturers to ensure safe, effective and high-quality drugs for
the American public.
The FDA encourages health care professionals and patients to report adverse
reactions or quality problems with any human drugs to the agency’s MedWatch
Adverse Event Reporting program:
Complete and submit the report online
at www.fda.gov/medwatch/report.htm; or
Download and complete the form, then submit it via fax at 1-800-FDA-
0178.
The FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and security of
human and veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the safety and security
of our nation’s food supply, cosmetics, dietary supplements, products that give off
electronic radiation, and for regulating tobacco products.”
Proceeding and decision of 294th meeting:
The Board deliberated the matter considering the facts of the case and decided as under:
i. Registrations of all Ranitidine containing products shall remain suspended.
Meanwhile status of ranitidine containing products will be reviewed in Reference
Regulatory Authorities and a comprehensive case shall be submitted before
Registration Board for its consideration. However during suspension period, the
manufacturers/importers shall submit the prescribed product renewal fee as and
when applicable to them.
ii. Manufacturer/importer of ranitidine containing product(s) shall
withdraw/remove all stocks from the market immediately.
iii. Cases pertaining to any seizures / not to dispose of / withheld shall be placed
before Registration Board if required.
Case No.02: REQUEST OF M/s NOVARTIS PHARMA (PAKISTAN) LTD, FOR
EXEMPTION OF NDMA TESTING IN VALSARTAN DUE TO
UNAVAILABILITY OF THE PRODUCTS IN THE MARKET.
The firm has requested that it has received the following consignments of valsartan. The firm
informed that the assistant director I & E has restricted the utilization till testing from the lab as
per decision of 291st meeting of DRB. The firm added that in the current scenario there is a chance
that the local testing may not be possible or delayed, which will delay the access of medicine to
the patients. Firm has provided CoA confirming testing of NDMA and NDEA in valsartan APIs
with assurance that valsartan of same batches has been used in manufacturing of following finished
products. The firm has requested to issue directions to lift the utilization restriction of the following
batches of Valsartan containing products;
Sr.
No.
MAT.
Code
Description of Item Batch
No. QTY(PC) SAP PO. Invoice No.
Received at
warehouse on
Minutes of 294th Meeting of Registration Board | 367
1.
709626 Exforge FCT
160/10mg Alu 2x14
PK
BPA63 10,000 4701504472
200153273 18-03-2020
2. 709648 Exforge FCT 80/5mg
Alu 2x14 PK BPD05 26,000 4701504474
3. 708615 Co-Diovan 80/12.5mg
FCT 2x14 PK TCY62 15,208 4701504470
2001529227
4.
725698 Co-Diovan FCT
160/12.5mg Alu
(2x14) PK
TAJ39 959
4701504482
725698 Co-Diovan FCT
160/12.5mg Alu
(2x14) PK
TAX31 987
725698 Co-Diovan FCT
160/12.5mg Alu
(2x14) PK
TCJ88 568
725698 Co-Diovan FCT
160/12.5mg Alu
(2x14) PK
TCX86 35,170
5. 709637 Exforge FCT 160/5mg
Alu 2x14 PK BNY90 11,918 4701504473
2001529218 18-03-2020
6.
717700 Exforge HCT FCT
160/25/10 mg Alu 2x7
PK
BPA14 14,000 4701504476
7. 725693 Diovan FCT 80mg Alu
(2x14) PK BPC18 34,000 4701504480
8. 725695 Diovan FCT 160mg
Alu (2x14) PK BPC89 40,000 4701504481
9. 709626 Co-Diovan 160/25mg
ALU 2x14 PK TDE03 8984 4701504483 2001531245 19-03-2020
M/s Novartis Phrma Karachi further requested to exempt requirement of local testing if APIs and
finished goods imported from SRA approved sites and CoAs stating clearly levels of impurities
NDMA within limits.
Background of the case:-
Valsartan is an orally active antihypertensive drug developed in the 1990s and is a selective
angiotensin II receptor blocker (ARB)
1. It relaxes the blood vessels and thus reduces blood pressure; it is also used for treating patients
with congestive heart failure and post myocardial infarction.
2. There are eight other ARBs that patients may be switched to if they discontinue their valsartan therapy
(1.Valsartan, 2.Telmisartan, 3. Losartan 4.Irbesartan 5.Irbesartan, 6.Azilsartan, 7.Olmesartan and
8.Olmesartan).
N-nitrosodimethylamine (NDMA) AS SAFETY ISSUE IN VALSERTAN
1. On 5 July 2018 the European Medicines Agency (EMA) reviewed medicines containing
valsartan following detection of an impurity, N-nitrosodimethylamine (NDMA), a probable
human carcinogen, in medicines from Zhejiang Huahai Pharmaceutical Co Ltd, Linhai, China.
Since the batches manufactured from this valsartan-active substance have been administered to
Minutes of 294th Meeting of Registration Board | 368
many patients, the EMA’s review focused on investigating the levels of NDMA in the products
and the potential impact on patients who have been taking them. The agency further issued
advisory notices on their website for patients not to stop taking their medicine.
2. The US Environmental Protection Agency found an association between NDMA and liver
toxicity, which could lead to liver cancer: NDMA exposure may be associated with bladder,
renal, pancreatic, intestinal, colon, and stomach cancers.
3. Immediately following the EMA’s review, 24 countries recalled approximately 2300 batches
of valsartan products (Germany, Norway, Finland, Sweden, Hungary, The Netherlands, Austria,
Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece,
Canada, Bosnia and Herzegovina, Bahrain, and Malta.
4. Hong Kong recalled 5 products of 2 companies and Canada recalled drug products of 5
companies.
5. The Drug Regulatory Authority of Pakistan on 12 July recalled valsartan-containing drugs
of nine manufacturers becoming the first developing country to announce separately the recall as
a precautionary measure to protect patient health.
6. The US Food and Drug Administration (FDA) on 13 July announced the voluntary recall of
five valsartan-containing products.
ACTION TAKEN BY DRAP:
The Drug Regulatory Authority of Pakistan on 12 July recalled valsartan-containing
drugs of nine manufacturers becoming the first developing country to announce separately the
recall as a precautionary measure to protect patient health. Accordingly the case was placed before
291st meeting of DRB held on 02-04 September 2019. Wherein, the board decided as under;
“Decision of the 291st meeting of Registration Board. Registration Board deliberated about
the identification of NDMA & EDMA as impurities which are carcinogenic and limits has been
prescribed by US FDA and EMA. Above the limits API as well as products poses threat to the
consumers. Keeping in view risk the Board decided as under:
i. Product registration holders shall ensure that the API as well as products containing
valsartan are within the prescribed limits impurities i.e. NDMA & EDMA. Every manufacturer
holding registration of valsartan containing products are under obligation of law to provide testing
facilities of these impurities for every consignment imported and brought into Pakistan. The
consignments should be accompanied with the certificates of analysis by the API manufacturers.
Meanwhile the manufacturers/importers may temporarily avail testing facilities of the any public
sector institutions till the establishment of their own facility. However, sampling will be done by
the area AD, DRAP and meanwhile the consignment will be released with the restriction that it
could only be used if it has qualified requisite tests from the public institutions/testing laboratories
and the certificate has been endorsed by the DRAP.
ii. Board constituted standard panels comprising of following for destruction of seized
stocks of valsartan API as well as finished products containing NDMA manufactured from the raw
material of M/s Zheijhiang Huahai pharmaceuticals, China/any other manufacturer contaminated
batches as the API has been withdrawn and banned internationally. a) Area Additional Director.
b) Area Federal Inspector of Drugs. c) Assistant Director I&E. Any two of the above with the
permission of Additional Director.
iii. The above mentioned panels will make coordination with the respective manufacturer
for the destruction of stocks and will prepare destruction certificates for the consideration of the
Minutes of 294th Meeting of Registration Board | 369
Registration Board. It shall be ensured that destruction /incineration is conducted in the presence
of panels and incineration certificates from the environment protection agency is also accompanied
with the panel report”
Due to the safety issue NDMA and NDEA testing in valsartan is internationally made
mandatory because of its carcinogenic activity has been established. DRAP in its 291st meeting
of DRB held on 02-04 September 2019 made the NDMA and EDMA test compulsory for every
consignment of valsartan before utilization. The request of the firm for exemption of local N-
nitrosodimethylamine (NDMA) testing of valsartan is placed before the board in view of the
decision taken in 291st meeting of Registration Board.
Proceeding of 294th Meeting:
The Board deliberated on the matter in detail. At the time when Registration Board decided to
make NDMA and NDEA testing compulsory for every consignment of valsartan before utilization,
there was no arrangement of worldwide testing of said impurities before in their country of origin.
The Board further deliberated that as M/s Novartis Pharma Pakistan has provided CoA of API
confirming testing of NDMA and NDEA and results are within acceptable limits. The Board also
considered M/s Novartis statement apprehending delay of the access of medicine to the patients
due to current scenario due to non or delayed local testing.
Representative of PPMA also informed that after emergence of NDMA and NDEA impurities
issues, now other API manufacturers have also started testing NDMA and NDEA in APIs.
Decision: After thorough deliberations and discussion by the Board and considering
documents submitted by M/s Novartis Pharma Pakistan, the Board decided as
under;
i. The imported finished products of above products containing Valsartan of
M/s Novartis (Pakistan) Limited shall be allowed for utilization.
ii. A comprehensive proposal will be presented in forthcoming meeting
regarding future strategy for testing of NDMA and NDEA in valsartan
containing products and API.
The meeting ended with vote of thanks to and from the Chair.