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Minutes for 278th

Meeting of Registration Board (29-31st January, 2018), DRAP | 1

Minutes for 278th

Meeting of Registration Board

held on 29-31st January, 2018.

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Item No. Detail of Item Page No.

Item No.I Confirmation of Minutes of 277th

meeting of Registration Board 04

Item No.II Pharmaceutical Evaluation & Registration Division

Pharmaceutical Evaluation Cell (PEC)

RRR Section …. …. …. …. …. …. …

Registration-I …. …. …. …. …. …. ...

Registration-II …. …. …… ….. ……

Registration-III …. …… ….. ….. …..

Registration-IV …. ….. ….. …… …..

Registration-V …. …. ….. ….. ….. …

(05 – 629)

05–452

453–538

539–563

564–591

592–600

601–614

615–629

Item No.III Biological Evaluation & Research Division 630 – 671

Item No.IV Quality Assurance & Lab Tesing Division 672 – 680

Item No.V Additional Agenda

A. Pharmaceutical Evaluation & Registration Division ….. . …

B. Biological Evaluation & Research Division …. …. …. . ….

681 – 763

764 – 774

Drug Regulatory Authority of Pakistan

T.F. Complex, Mauve Area, G 9/4

Islamabad.

Minutes for 278th


278th

meeting of Registration Board was held on 29-31st

January, 2018 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 meeting was attended by the following:

1. Dr. Rafeeq Alam Khan, Meritorious Professor, Department of Pharmacology,

University of Karachi

Member

2. Maj.Gen.Dr.Tahir Mukhtar Sayed Commandant AFIRM, Head of Department of Medicine,

AMC, Rawalpindi

Member

3. Dr. Ghulam Sarwar, Dean, Faculty of Pharmacy, Jinnah University for Women,

Karachi

Member

4. Dr.Qurban Ali, Ex-Director General, National Veterinary Laboratory, Islamabad.

Member

5. Dr.Aslam Shah, Senior Manager, Pharmacy & Purchase, Indus Hospital, Karachi

Member

6. Muhammad Aslam Assistant Draftsman-II, Ministry of Law & Justice

Member

7. Dr. Amanullah Khan Director, Drugs Testing Laboratory, Quetta

Government of Balochistan

Member

8. Mr. Abid Hayat Director Drugs Testing Laboratory, Peshawar

Government of Khyber Pakhtunkhwa.

Member

9. Dr. Shafiq ur Rahman Director, Drugs Testing Laboratory, Lahore

Government of Punjab.

Member

10. Syed Muzaffar Ali Jafri Director, Drugs Testing Laboratory, Karachi

Government of Sindh.

Member

11. Dr. Shaikh Akhter Hussain, Director, Medical Device / QA&LT Divisions, DRAP

Member

12. Dr. Noor-us-Saba, Director, Biological Drugs Divisions, DRAP

Member

13. Mr. Abdullah, Additional Director (PE&R) Secretary

Dr. Shafiq ur Rahman, Director DTL, Government of the Punjab attended last two days

of the meeting. Maj.Gen. Tahir Mukhtar Syed and Mr. Abid Hayat, Director DTL KPK didn’t

attend the meeting on 31st January, 2018.

Minutes for 278th


Dr. Shaikh Akhtar Hussain, Director Medical Device/QA&LT Divisions attended the

meeting on 31st January, 2018 only. Dr. M. Fakhrudding Amar, Additional Director (QC)

attended the meeting on 29-30th

January, 2018 as representative of QA&LT Division, DRAP.

Mr. Zaheer-ud-Din M. Babar (Deputy Director R.I/R.IV), Tehreem Sara (Deputy

Director, RRR), Mr.Babar Khan (Deputy Director (R.III) / Incharge-PEC), Mr. Muhammad

Amin (Deputy Director, R.II) assisted in presenting the agenda of PE&R Division. M. Akhtar

Abbas Khan (Deputy Director), M. Muneeb Cheema, M.Zubair Masood and Mr. Khurram

Khalid (Assistant Directors) presented agenda of Biological Drugs Division. Mst. Sadaf Ahmad

and Mst. Gulnaz Yaqoob (Assistant Directors, QC) presented agenda of Quality Control,

Division.

Mr. Shamim Ahmed and Mr. Arshad Mehmood (PPMA), Mr. Nadeem Alamgir (Pharma

Bureau) and Mr. Atam Parkash (PCDA) attended the meeting as observers.

Minutes for 278th


Item No. I: Confirmation of minutes of 277th

meeting of Registration Board.

277th

meeting of Registration Board was held on 27-29th

December, 2017. The draft

minutes were circulated among the members of meeting on 23.01.2017 with the request to forward

their comments (if any). No comments were received and thus draft minutes were approved by

Chairman, Registration Board.

Decision: Registration Board confirmed the minutes of 277th

meeting.

Minutes for 278th


Pharmaceutical Evaluation Cell

S.No. Details

Case No. 01 Review of Formulations

Case No. 02 Registration applications for local manufacturing of (Human) drugs

a) Registration applications submitted with differential fee

b) Registration applications submitted with full fee

i. New cases

ii. Deferred cases

Case No. 03 Registration applications of newly granted DML or New section (Human)

a. New DML

b. New/Additional section(s)

c. Deferred cases

Case No. 04 Registration applications for local manufacturing of (veterinary) drugs

a. Routine Applications

b. Deferred Cases

Case No. 05 Registration applications of newly granted DML or New section

(Veterinary)

a. New DML /section

Case No. 06

Registration applications of categories to be considered on priority

a. Applications for registration of drugs or Local Manufacturing

b. Export Facilitation

c. Finished Import

Case No. 07

Registration applications of import cases

a. Import routine cases (Human)

b. Import routine cases (Veterinary)

c. Import Deferred cases

i. Human

ii. Veterinary

Case No. 08 Registration applications of drugs for which stability study data is

required to be verified

a. New cases

b. Deferred cases

c. Verification of stability study data

d. Exemption from onsite verification of stability data

Case No. 09 Miscellaneous Cases

Total Cases: 848

Minutes for 278th


Sr. No Name of Evaluator Title

1. Mr. Muhammad Tahir Waqas Evaluator PEC-I

2. Mr. Ammar Ashraf Awan Evaluator PEC-II

3. Mr. Muhammad Haseeb Tariq Evaluator PEC-III

4. Mst.Farzana Raja Evaluator PEC-IV

5. Mst. Iqra Aftab Evaluator PEC-V

6. Mr. Muhammad Umar Latif Evaluator PEC-VI

7. Mst. Sidra Khalid Evaluator PEC-VII

8. Mst. Haleema Sharif Evaluator PEC-VIII

9. Mr. Farooq Aslam Evaluator PEC-X

10. Mst. Najia Saleem Evaluator PEC-XI

11. Syed Ajwad Bukhari Evaluator PEC-XII

12. Mst. Mehwish Javed Khan Evaluator PEC-XIII

13. Mr. Muhammad Ahsan Hafiz Evaluator PEC-XIV

Minutes for 278th


Case No. 01: Review of Formulation

Evaluator PEC-III

1. Fosfomycin 250mg/5ml oral suspension

The formulation is available in Spain and registered by Spanish Agency of Medicines and

Health Products Spain in the same strength and dosage form. The details of product registration

are as follows

Brand Name: FOSFOCINA Suspension 250mg/5ml

Market Authorization number: 50880

Pharmaceutical form: Oral suspension

Composition: Each 5ml suspension contains fosfomycin (as calcium) ……….. 250 mg

Marketing Authorization holder: LABORATORIOS ERN, S.A. Barcelona, España

Link for reference: https://www.aemps.gob.es/cima/publico/detalle.html (Accessed on 19-12-2017).

The case was discussed in 277th

meeting of Registration Board and was deferred for clarification

of salt form of fosfomycin. Now, the salt form has been verified from the patient information

leafelet of Fosfocina suspension and the correct salt form is Forfomycin (as Calcium). Now the

case is submitted before the Board for consideration.

Sr.

No.

Name and

Address of

Manufacturer /

Applicant.

1. Brand Name 2.

Dosage Form 3.

Composition 4.

Pharmacological

Group.

1. Type Form.

2. Type of

Application.

3. Demanded

Price/Pack Size.

4. Initial Date &

Diary.

5. Date on which

fee becomes

complete

according to type

of application /

Form.

GMP Inspection

report

Decision of

previous meeting

Evaluation

by PEC

1. M/s Sigma Pharma

International

Pvt.

Ltd E-50,

N.W.I.Z., Port

Qasim

Karachi

Fosil 250mg/5ml

Dry Suspnsion

Each 5ml contains:-

Fosfomycin (as

Fosfomycin

Calcium) ....250mg

(Anti Bacterial

Agent )

Form 5

17-11-2014

(219)

Rs. 20,000/-

As Per SRO/

Pack 60ml

15-09-2017:

Acceptable

level of

cGMP

compliance

Deferred for

confirmation of

formulation

approval in

reference

Stringent

Regulatory

Agencies

(M-246)

Decision: Approved with Innovator’s specifications

2. M/s Mega Pharmaceuti

cals,

Limited

Lahore

MEGAFOS

Suspension

250mg/5ml

Each 5ml contains:

Fosfomycin

…….250mg

Antibiotic

Form-5

Dy.No: 10547

dated:12.11.10

Rs.8000/-

dated:12.11.10

Rs.12,000/-

dated 05-08-13

Deferred for

confirmation of

availability in

reference

SRA’s.

2. Final notice

for

rectification of

GMP

report

within 1

year is not

confirmed

https://www.aemps.gob.es/cima/publico/detalle.html

Minutes for 278th


As per SRO/

Pack of 60ml

shortcomings/

observations.

(M-247)

Decision: Deferred for submission of latest GMP inspection report conducted within a period of

last 1 year by DRAP

3. M/s Vision Pharmaceutic

als, Plot #

22-23,

Industrial

Triangle

Kahuta Road,

Islamabad.

FOSF Suspension

Each 5ml Contains:-

Fosfomycin

(as calcium)

……250 mg

Antibiotic

Form 5

Dy No.2047

dated 19-03-15

Rs. 20,000/-

As Per SRO/

Pack of 60ml

22-2-2017:

GMP granted

Deferred for

confirmation of

formulation in

reference drug

agencies.

(M-249)


4. M/s Caliph Pharmaceutic

als (Pvt.) Ltd,

Plot # 17,

Special

Industrial

Zone,

Risalpur,

KPK.

Fosfo Dry

Suspnesion

Each 5 ml (after

reconstitution)

contains

Fosfomycin

calcium eq to

fosfomycin...250mg

Broad Spectrum

antibiotic

Form 5

Rs. 20,000/-

Dy. No.905

dated

13-04-2012

Pack of

60 ml /

Rs.97.62

07-03-2017

declaring

satisfactory

level of GMP

compliance

Deferred for

confirmation of

approval status

by reference

regulatory

authorities

(M-254)


5. M/s GT pharma (pvt)

ltd. plot # 713

b sundar

industerial

estate

raiwind road

Lahore.

MYFOSIN Dry

Powder

Suspension

Each 5ml

reconstituted

suspension Contains

Fosfomycin

……..250mg

(Antibiotic)

Form 5

Rs. 20,000/-

Dy. No. 2692

11.12.2015

Pack size of

1 x 60ml as

per

price fixed by

Government

08-08-2017

and report

concludes

GMP

compliance

status

Deferred for

confirmation

of approval

status by

reference

regulatory

authorities.

(M-256)

Decision: Deferred for clarification of salt form of API in comparison to refrence product.

6. Aries Pharmaceutic

als 1-W,

Industrial

Estate

Hayatabad

Peshawar,

Pakistan

ZEFCIN 250mg

oral suspension

Each reconstituted 5

mL contains

Fosfomycin calcium

monohydrate eq. to

fosfomycin

……250mg

(Antibiotic)

Form 5

Dy No. 576

14-10-2016

PKR 20,000/-

Dated 13-10-

2016

10-03-17;

Panel

recommended

grant of

additional

section

Deferred for

evidence of

approval by

reference

regulatory

authorities as

reference

submitted /

provided is from

Spain, which is

not a reference

regulatory

authority(M-268)

Decision: Deferred for following:

Clarification of salt form of API in comparison to refrence product.

Deferred for submission of latest GMP inspection report conducted within a period of last 1 year by DRAP.

Minutes for 278th


7. M/s Astellas Pharmaceuti

cal (Pvt) Ltd.

Industrial

Estate,

Hayatabad,

Peshawar

Mifose Dry

suspension 250mg

/5ml

Each 5ml

suspension contains

Fosfomycin

Calcium Eq to

Fosfomycin..250mg

Broad Spectrum

Antibiotic

Form-5

Diary No:6275,

14/06/2017,

Rs: 20,000/-

60 ml/ As Per

SRO

13-02-2017

very good

level of

compliance

with GMP.

Deferred for

evidence of

approval of

applied

formulation by

reference

regulatory

authorities.

(M-272)


8. M/s Mission Pharmaceuti

cals (Pvt)

Ltd., Plot

No. A-94,

SITE Super

Highway

Karachi

Misfos 250mg/5ml

Oral dry suspension

Each 5ml contains

Fosfomycin as

calcium…250mg

(Antibiotic /

antibacterial)

Form 5

Dy No. 718:

28-10-2015

PKR 20,000/-:

28-10-2015

60ml: Rs. 90/-

21-12-2016:

GMP

compliant

status.

Deferred for

evidence of

approval in

reference

regulatory

authorities

(M-273)

Decision: Deferred for submission of latest GMP inspection report conducted within a period of

last 1 year by DRAP

Case No. 02: Registration applications for local manufacturing of (Human) drugs

a) Registration applications submitted with differential fee Evaluator PEC-III

Sr.# Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name +

Dosage Form +

Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of Form

Initial date,

diary

Fee including

differential fee

Demanded Price /

Pack size

Remarks on the

formulation (if any)

including

International status

in stringent drug

regulatory agencies /

authorities

Me-too status

GMP status as

depicted in latest

inspection report

(with date) by the

Evaluator

Remarks of the

Evaluator.

9. M/s Medizan Laboratories

(Pvt) Ltd, Plot

No. 313,

Industrial

Triangle,

Kahuta Road,

Islamabad

DELORT 5mg

Tablets

Each film coated

tablet contains:-

Desloratadine

……….. 5mg

(Anti Histamine)

Form 5

Dy. No.458

15-12-2010

Rs.8000/-

(15-12-2010)

+

Rs.12,000/-

(17-11-2014)

1x10’s

As Per SRO

CLARINEX by

Merck

(USFDA approved)

Alenor by Macter

Last inspection

report dated

10.4.2017 confirms

satisfactory

compliance to GMP.

Firm has claimed

in house

specifications

and the product

monograph is

not present in

any official

pharmacopoeia


Minutes for 278th


10. M/s Zamko Pharmaceutical

s 641-A Sunder

Industrial

estate, Lahore

Toll

manufactured

by English

Pharma,

Lahore

ZAMPIME 500mg

Injection

Each vial contains:-

Cefepime as

hydrochloride..500mg

Cephalosporin

Form-5

17-05-2013

Dy No. 3130

Rs. 20,000/-

(16-05-2013)

+

Rs. 30,000/-

(17-05-2013)

1’s

Rs.300.00/Per vial

Maxipime Injection

by Hospira

(USFDA)

Maxipime inj by

Bristol Mayer

Squibb

The applicant firm

do not hold a valid

DML

The applicant firm do not hold

a valid DML

Decision: Registration Board rejected the application since the firm does not hold valid DML

11. M/s Zamko Pharmaceutical

s 641-A Sunder

Industrial

estate, Lahore

Toll

manufactured

by English

Pharma,

Lahore

ZAMTAX 500mg

Injection

Each vial contains:-

Cefotaxime sodium

eq.to Cefotaxime

….…..500mg

Cephalosporin

Form-5

17-05-2013

Dy No. 3125

Rs. 20,000/-

(16-05-2013)

+

Rs. 30,000/-

(17-05-2013)

1’s vial

Rs.140/1’s

Claforan Injection

By

US Pharm Holding

(USFDA)

Claforan inj by

Sanofi Aventis

The applicant firm

do not hold a valid

DML

The applicant firm do not hold

a valid DML

Decision: Registration Board rejected the application since the firm does not hold valid DML

12. Genome Pharmaceutical

s (Pvt) Ltd.,

Plot # 16/I-

Phase-IV,

Industrial

Estate Hattar

NALID 80mg Tablets

Each tablet contains:-

Nadolol…………….8

0mg

(Nonselective beta-

adrenergic receptor

blocking agent)

Form 5

(DUPLICATE

DOSSIER)

PKR 8,000/-

(17-05-2011)

+

PKR 12,000/-

(26-11-2014)

10’s

As per SRO

Corgard 80mg tablet

by Aventis

(MHRA Approved)

Norgar tablets by

Pulse Pharma

Panel Inspection on

14-01-2017, No

observations as

informed by QA.

Firm has claimed in house

specifications

and the product

monograph is

not present in

any official

pharmacopoeia


Evaluator PEC-VI 13. M/s Treat

Pharmaceut

icals, Bannu

Locain Injection

20mg/10ml

Each 10ml ampoule

contains:

Lidocaine as HCl

(anhydrous)…..20mg

(Local anaesthetic)

Form 5

Dy. No.16

09-6-2011

Rs.8,000/-

(9-6-2011)

+ Rs.12,000

29-7-2013

(Duplicate)

50’s (10ml)

As per SRO

Could not be

confirmed

Could not be

confirmed

Last inspection report

5-10-2017 the panel

recommended grant

of renewal and

additional section

Firm has liquid injection (general)

section.

Fee challan photocopy is

attached.

International availability in RRA

and me too status

could not be

confirmed.

Minutes for 278th


14. Decision: Deferred for following:

Evidence of approval of applied formulation in reference regulatory authorities/agencies which were declared/approved by the Registration Board.

Evidence of applied formulation/drug already approved by DRAP (generic / me-too status) alongwith registration number, brand name and name of firm.

15. M/s Treat Pharmaceut

icals, Bannu

Treatagen Injection

20mg/2ml

Each 2ml ampoule

contains:

Gentamycin (as

sulphate)……20mg

(Antibiotic)

USP

Form 5

Dy. No.16

9-6-2011

Rs.8,000/-

(9-6-2011)

+

Rs.12,000

29-7-2013

(Duplicate)

50’s (10ml)

As per SRO

USFDA Approved

10mg/ml

Genticillin Paediatric

Injection 20mg/2ml

Reg # 20563


5-10-2017 the panel

recommended grant

of renewal and

additional section

Fee challan

photocopy is attached.

16. Decision: Approved. Reference will be sent to Budget & Accounts Division for verification of challan and Board authorized its Chairman for the issuance of registration letter.

17. M/s Treat Pharmaceut

icals, Bannu

Amikat Injection

500mg/2ml

Each 2ml ampoule

contains:

Amikacin (as sulfate)

…..…..500mg

(Aminoglycoside)

USP

Form 5

Dy. No.177

9-06-2011

Rs. 12,000/-

(29-7-2013)

+

Rs.8,000/-

(9-6-2011)

50’s (10ml)

As per SRO

Amikacin 250 mg/ml

Injection by M/s

Hospira UK Ltd,

MHRA approved

Amikin Injection by

M/s GSK


5-10-2017 the panel

recommended grant

of renewal and

additional section

Firm has changed the

strength from 50mg/

ml to 500mg/ 2ml and

deposited Fee of

Rs.20,000/- on

19.01.2018

18. Decision: Approved. Reference will be sent to Budget & Accounts Division for verification of challan and Board authorized its Chairman for the issuance of registration letter.

Minutes for 278th


b) Registration Applications Submitted with Full Fee.

I. New cases Evaluator PEC-II

19. Name and address of manufacturer / Applicant

Max Pharmaceuticals, Islamabad

Brand Name +Dosage Form + Strength Maxtelium 10mg tablets

Composition Each tablet contains:

Domeperidone……….10mg

Diary No. Date of R& I & fee Dy. No.3051; 12-07-2016; Rs.20,000/- (12-07-2016)

Pharmacological Group Antibiotic

Type of Form Form 5

Finished product Specification Manufacturers specification

Pack size & Demanded Price 1x 10’s, 3 x 10’s & 5 x 10’s; As per SRO

Approval status of product in Reference

Regulatory Authorities.

Motilium10mg tablet of M/s Janssen-Cilag Pty Ltd

approved by TGA of Australia

Me-too status Epodom 10mg Tablets by M/s Atlantic Pharmaceutical

(Pvt) Ltd, (Reg#062326)

GMP status Not provided

Remarks of the Evaluator.

Decision: Deferred for submission of latest GMP inspection report conducted within a

period of last 1 year by DRAP


M/s Theramed Pharmaceutical, 45-Km, Multan Road,

Lahore.

Brand Name +Dosage Form + Strength Essam 20mg tablet

Composition Each film coated tablet contains:

Escitalopram (as oxalate) …… 20mg


Pharmacological Group Antidepressant

Type of Form Form-5

Finished product Specification USP

Pack size & Demanded Price 10’s, 14’s, 28’s; As awarded by DRAP

Approval status of product in

Reference Regulatory Authorities.

Approved by MHRA of UK

Me-too status Zavesca tablet 20mg of Getz Pharma. (Reg.#045281)

GMP status Panel inspection report dated 10-10-2017 for Renewal

of DML and grant of additional sections.

Remarks of the Evaluator. Firm has submitted one page reports of accelerated stability studies without relevant documents i.e.

chromatograms, lab reports, raw data sheets etc.

Upon communication of above observation firm has submitted stability study analytical sheet which shows

that stability studies have been performed on in-house

specifications/method whereas USP monograph is

available for applied formulation.

Only raw data sheets have been submitted, while UV spectrums or HPLC chromatograms should be

submitted to confirm the performance of stability

studies.

Now the firm has submitted that “the accelerated

stability data analytical sheets submitted for applied

Minutes for 278th


formulation are not being justified, so we are giving

undertaking/commitments, and we will submit all the

required data to DRAP before the marketing of said

product.”

Decision: Approved



Lahore.

Brand Name +Dosage Form + Strength Theravirin 50mg/5ml Syrup

Composition Each 5ml contains:

Ribavirin …… 50mg


Pharmacological Group Antiviral

Type of Form Form-5


Pack size & Demanded Price 60ml,90ml,120ml; As awarded by DRAP



Rebetol 40mg/ml approved by USFDA

Me-too status Virex Syrup of M/s Wilson’s Pharmaceuticals.

(Reg.#029584)



Remarks of the Evaluator. Evidence of approval of applied formulation in reference regulatory authorities/agencies which were

declared/approved by the Registration Board as

submitted reference is of different composition than

applied.

Firm has submitted one page reports of accelerated stability studies without relevant documents i.e.


Upon communication of above observation only raw data sheets have been submitted, while UV spectrums

or HPLC chromatograms should be submitted to

confirm the performance of stability studies.

Now the firm has submitted that “the accelerated stability data analytical sheets submitted for applied




product.”

Decision: Deferred for evidence of approval of applied formulation in reference regulatory

authorities/agencies which were declared/approved by the Registration Board.



Lahore.

Brand Name +Dosage Form + Strength Neskay 4mg tablet

Composition Each chewable tablet contains:

Montelukast (as sodium) …… 4mg


Pharmacological Group Leukotriene inhibitor

Type of Form Form-5


Pack size & Demanded Price 10’s, 14’s,20’s & 30’s; As awarded by DRAP

Minutes for 278th




Approved by USFDA

Me-too status Exma Tablet 4mg of M/s Asian Continental Karachi.

(Reg.#081007)



Remarks of the Evaluator. Firm has submitted one page reports of accelerated stability studies without relevant documents i.e.


Upon communication of above observation firm has submitted stability study analytical sheet which

shows that stability studies have been performed on

in-house specifications/method whereas USP

monograph is available for applied formulation.



studies.






product.”

Decision: Approved.



Lahore.

Brand Name +Dosage Form + Strength Worx 40mg tablet

Composition Each enteric coated tablet contains:

Pantoprazole “as sodium sesquihydrate”…… 40mg


Pharmacological Group Proton pump inhibitor

Type of Form Form-5





Approved by MHRA

Me-too status Cantrofast Tablets of M/s Candid Pharmaceuticals

(Reg.#082031)



Remarks of the Evaluator. You have submitted one page reports of accelerated stability studies without relevant documents i.e.


Upon communication of above observation firm has submitted stability study analytical sheet which

shows that stability studies have been performed on

in-house specifications/method whereas USP

monograph is available for applied formulation.



Minutes for 278th


studies.



undertaking/commitments, and we will submit all

the required data to DRAP before the marketing of

said product.”

Decision: Approved



Lahore.

Brand Name +Dosage Form + Strength Seef 50mg tablet


Levosulpride …… 50mg


Pharmacological Group Antipsycotic

Type of Form Form-5

Finished product Specification Manufacturer’s specifications.




Levidomed 50mg tablets of M/s Medochemie Ltd.

approved by AIFA of Italy.

Me-too status Sulvoric 50mg of M/s High-Q, Karachi (Reg.#070485)



Remarks of the Evaluator. No USP or BP monograph is available for applied formulation.

Firm has submitted one page reports of accelerated stability studies without relevant documents i.e.


Upon communication of above observation only raw data sheets have been submitted, while UV spectrums

or HPLC chromatograms should be submitted to

confirm the performance of stability studies.





product.

Decision: Approved with innovator’s specification



Lahore.

Brand Name +Dosage Form + Strength Seef 25mg tablet


Levosulpride …… 25mg

Diary No. Date of R& I & fee Dy. No.1634 30-11-2016; Rs.20,000/- (30-11-2016)

Pharmacological Group Antipsycotic

Type of Form Form-5





Levidomed 25mg tablets of M/s Medochemie Ltd.

approved by AIFA of Italy.

Me-too status Sulvoric 25mg of M/s High-Q, Karachi (Reg.#070484).

Minutes for 278th





You have submitted one page reports of accelerated stability studies without relevant documents i.e.


Upon communication of above observation only raw data sheets have been submitted, while UV

spectrums or HPLC chromatograms should be


studies.





said product.”




Lahore.

Brand Name +Dosage Form + Strength Spar 20mg tablet


Piroxicam β-Cyclodextrin …… 20mg

Diary No. Date of R& I & fee Dy. No.1635 30-11-2016; Rs.20,000/- (30-11-2016)

Pharmacological Group NSAID

Type of Form Form-5





Approved by ANSM of France

Me-too status Ripax 20 mg by M/s Hilton



Remarks of the Evaluator. No USP or BP monograph is available for applied formulation

You have submitted one page reports of accelerated stability studies without relevant documents i.e.


Upon communication of above observation only raw data sheets have been submitted, while UV

spectrums or HPLC chromatograms should be


studies.





said product.”

Decision: Approved with innovator’s specification.

Minutes for 278th




Lahore.

Brand Name +Dosage Form + Strength Essam 10mg tablet


Escitalopram (as oxalate) …… 10mg



Type of Form Form-5


Pack size & Demanded Price 10’s, 14’s, 28’s; As awarded by DRAP



Approved by MHRA of UK

Me-too status Zavesca tablet 10mg of Getz Pharma. (Reg.#045279)



Remarks of the Evaluator. You have submitted one page reports of accelerated stability studies without relevant documents i.e.


Upon communication of above observation firm has submitted stability study analytical sheet which shows

that stability studies have been performed on in-house

specifications/method whereas USP monograph is

available for applied formulation.



studies.






product.”

Decision: Approved.


M/s Jinnah Pharmaceuticals (Pvt.) Ltd, 13-Km Lahore

Road, Multan

Brand Name +Dosage Form + Strength Lowcost 4mg sachet

Composition Each sachet contains:

Montelukast (as sodium) …… 4mg


Pharmacological Group Leukotriene antagonist

Type of Form Form-5


Pack size & Demanded Price 1 x 14’s; Rs. 182/-



Approved by USFDA

Me-too status Aerotel Sachet of M/s Highnoon Laboratories.

(Reg.#044768)

GMP status Last inspection dated 01-06-2016

Remarks of the Evaluator. Latest GMP inspection report conducted within a period

of last 1 year by DRAP.

Minutes for 278th


Decision: Registration Board referred the case to QA & LT Division to conduct GMP

inspection of Firm on priority. The Board also directed the firm to change the brand name.


M/s Jinnah Pharmaceuticals (Pvt.) Ltd, 13-Km Lahore

Road, Multan

Brand Name +Dosage Form + Strength Pediawin sachet

Composition Each sachet contains:

Sodium chloride …… 2.6gm

Sodium citrate ……. 2.90gm

Potassium chloride ….. 1.50gm

Glucose anhydrous …… 13.5 gm


Pharmacological Group ORS

Type of Form Form-5

Finished product Specification International Pharmacopoeia

Pack size & Demanded Price 1 x 20 ’s: Rs. 300/-



WHO recommended Low osmolar ORS formulation

Me-too status Oragil Sachet of M/s Glitz Pharmaceuticals

(Reg.#038628)

GMP status Last inspection dated 01-06-2016

Remarks of the Evaluator. Latest GMP inspection report conducted within a period

of last 1 year by DRAP.

Decision: Registration Board referred the case to QA & LT Division to conduct GMP

inspection of Firm on priority.

Evaluator PEC-VII


M/s Nawan Lab 136 sector 15, Korangi industrial area,

Karachi

Brand Name +Dosage Form + Strength Ceftrix 1gm Injection IM

Composition Each vial contains:

Ceftriaxone (as ceftriaxone sodium)…..….1 gm

Diary No. Date of R& I & fee Dy.No. 162, 03-2-2017, Rs.20,000/-

Pharmacological Group Cephalosporin Antibiotic

Type of Form Form-5

Finished Product Specification USP

Pack size & Demanded Price 1’s / As Per SRO



Ceftriaxone of sandoz (USFDA)

Me-too status 3-zone of Zeb

GMP status Last GMP Inspection conducted on 26-9-2017 with

conclusive remarks of satisfactory.

Remarks of Evaluator

Decision: Approved



Karachi

Brand Name +Dosage Form+ Strength Ceftrix 250 Injection IM


Ceftriaxone (as ceftriaxone sodium)…..….250 mg

Diary No. Date of R& I & fee Dy.No. 42, 12-1-2017, Rs.20,000/=

Minutes for 278th



Type of Form Form-5





Ceftriazone of sandoz (USFDA)



conclusive remarks of follow up.


Decision: Approved



Karachi

Brand Name +Dosage Form + Strength Ceftrix 500 Injection IM


Ceftriaxone (as ceftriaxone sodium)…..….500 mg

Diary No. Date of R& I & fee Dy.No. 1065, 12-1-2017, Rs.20,000/=


Type of Form Form-5





Ceftriazone of sandoz (USFDA)



conclusive remarks of follow up.


Decision: Approved


M/s Semos Pharmaceuticals, Plot # 11, sector 12-A,

Industrial area, North Karachi

Brand Name +Dosage Form + Strength Oxiten 20mg Tablet

Diary No. Date of R& I & fee Dy. NO.1078, 10-01-2017, Rs: 20,000/-

Composition Each film coated tablet Contains:

Paroxetine as HCl …..…20mg

Pharmacological Group Antidepressant (SSRI)

Type of Form Form 5


Pack size & Demanded Price 10’s 14’s, 20’s, 50’s &100’s / As per PRC



PAXIL by Apotex (US FDA)

Me-too status Peroxa of organic Pharma

GMP status Last inspection conducted on 17-10-2017“with good GMP

compliance.”


Decision: Approved

Minutes for 278th



M/S Reign Pharmaceuticals, Karachi contract

manufacturing by M/s Semos Pharmaceuticals, Plot # 11,

sector 12-A, Industrial area, North Karachi

Brand Name +Dosage Form + Strength REXONE 500MG IV INJECTION


Composition Each vial Contains:

Ceftriaxone sodium eq.to Ceftriaxone ……….500mg.

Pharmacological Group 3RD

Generation Cephalosporin

Type of Form Form 5


Pack size & Demanded Price 1’s (270/- As per PRC)



Ceftriaxone By Lupin pharma (USFDA)

Me-too status 3-Zone by Zeb pharma


compliance.”

Remarks of the Evaluator. • Reign Pharmaceuticals has 9 section,

Firm are already contract manufacturing for:

1. Medisure = 3 products

Decision: Approved



manufacturing M/s Semos Pharmaceuticals, Plot # 11,


Brand Name +Dosage Form + Strength REXONE 1000 MG IV INJECTION



Ceftriaxone sodium eq.to Ceftriaxone…….1000mg.

Pharmacological Group 3rd

Generation Cephalosporin

Type of Form Form 5


Pack size & Demanded Price 1’s (As per PRC)



Ceftriaxone By Lupin pharma (USFDA)

Me-too status 3-Zone by Zeb pharma


compliance.”




Decision: Approved





Brand Name +Dosage Form + Strength REFTOX 500mg IV Injection



Cefotaxime (as sodium) eq.to Cefotaxime……….500mg.

Pharmacological Group Cephalosporine Antibiotic (intravenous Use)

Minutes for 278th


Type of Form Form 5





Claforan Injection by M/s US Pharm Holdings, (USFDA)

Me-too status Baxim Injection 500mg by M/s Nabiqasim


compliance.”




Decision: Approved





Brand Name +Dosage Form + Strength REFTOX 250MG IV INJECTION



Cefotaxime (as sodium) USP eq.to

Cefotaxime……….250mg.

Pharmacological Group Cephalosporin Antibiotic (intravenous Use)

Type of Form Form 5





Cefotaxime of HOSPIRA ( Health Canada )

Me-too status Baxim Injection 250mg by M/s Nabiqasim


compliance.”




Decision: Approved





Brand Name +Dosage Form + Strength RAYFIX DS 200mg/5ml Dry suspension


Composition Each 5ml reconstituted Suspension Contains:

Cefixime trihydrate eq. to

Cefixime ….200mg.

Pharmacological Group Cephalosporin

Type of Form Form 5


Pack size & Demanded Price 30ml, 60ml / As per PRC



Suprax of Lupin (USFDA)

Me-too status Cefiget of Getz

Minutes for 278th



compliance.”

Remarks of the Evaluator. Reign Pharmaceuticals has 9 section,



Decision: Approved





Brand Name +Dosage Form + Strength RAYFIX DS 100mg/5ml


Composition Each 5ml reconstituted Suspension Contains:

Cefixime trihydrate eq. to Cefixime ….100mg.

Pharmacological Group Antibacterial for Systemic use, belonging to class of

cephalosporin

Type of Form Form 5


Pack size & Demanded Price 30ml, 60ml (30ml 150/-) As per PRC



SUPRAX 100mg/5ml dry powder suspension by M/s

LUPIN LTD (USFDA)

Me-too status Cefamax 100mg/5ml dry suspension by M/s Pulse Pharma


compliance.”




Decision: Approved





Brand Name +Dosage Form + Strength RAYFIX 400mg Capsule


Composition Each Capsule Contains:

Cefixime trihydrate eq. to Cefixime ….400mg.

Pharmacological Group Antibacterial for Systemic use, belonging to class of

cephalosporin

Type of Form Form 5

Finished Product Specification JP

Pack size & Demanded Price 5’s As per PRC



SUPRAX Capsule 400mg by M/s LUPIN LTD (USFDA)

Me-too status Cefiget 400mg Capsules by M/s Getz Pharma


compliance.”




Decision: Approved

Minutes for 278th






Brand Name +Dosage Form + Strength REFTOX 1000mg IV INJECTION



Cefotaxime (as sodium) eq.to Cefotaxime……….1000mg.

Pharmacological Group Cephalosporin Antibiotic (intravenous Use)

Type of Form Form 5


Pack size & Demanded Price 1’s (235/- As per PRC)



Claforan Injection by M/s US Pharm Holdings, USFDA

Me-too status Baxim Injection 1gm IV by M/s Nabiqasim


compliance.”




Decision: Approved




Brand Name +Dosage Form + Strength SEBROL Forte 650mg/50mg Tablet

Diary No. Date of R& I & fee Dy. NO 997, 13-02-2017, Rs: 20,000/-

Composition Each Tablet Contains:

Paracetamol (BP)………650mg.

Orphenadrine Citrate(BP)…….50mg.

Pharmacological Group Analgesic/ Muscle relaxants

Type of Form Form 5

Finished Product Specification Innovator

Pack size & Demanded Price 10’s , 20’s, 50’s, 100’s As per SRO



NA

Me-too status Nuberol forte of M/s Searle Pakistan


compliance.”

Remarks of the Evaluator. Evidence of approval of applied formulation in reference

regulatory authorities/agencies missing

Decision: Deferred for evidence of approval of applied formulation in reference regulatory

authorities/agencies which were declared/approved by the Registration Board




Brand Name +Dosage Form + Strength SEBROL 450mg/35mg Tablet


Composition Each Tablet Contains:

Paracetamol ………450mg.

Orphenadrine Citrate …….35mg.

Pharmacological Group Analgesic/ Muscle relaxants

Minutes for 278th


Type of Form Form 5

Finished Product Specification Innovators

Pack size & Demanded Price 10’s , 20’s, 50’s, 100’s /As per PRC



NORGESIC Tablets -TGA Australia

Me-too status NUBEROL Searle Pakistan


compliance.”


Decision: Approved with innovator’s specifications




Brand Name +Dosage Form + Strength RANCE 500mg Tablet


Composition Each extended release tablet contains:

Ranolazine ……500mg.

Pharmacological Group Antianginal drugs

Type of Form Form 5

Finished Product Specification Manufacturer

Pack size & Demanded Price 7’s 10’s, 14’s, 20’s, 50’s As per PRC



RANEXA by GILEAD (USFDA)

Me-too status Rangizin XR 1000mg by M/s Macter Intr. Karachi

(Reg#076770)


compliance.”

Remarks of the Evaluator. USP/BP monograph of this formulation is not available.

Decision: Approved with innovator’s specifications




Brand Name +Dosage Form + Strength RANCE 1000mg Tablet

Diary No. Date of R& I & fee Dy. NO. 995, 13-02-2017, Rs: 20,000/-

Composition Each extended release tablet contains:

Ranolazine ……1000mg.

Pharmacological Group Antianginal drugs

Type of Form Form 5


Pack size & Demanded Price 7’s 10’s, 14’s, 20’s, 50’s As per PRC



RANEXA by GILEAD (USFDA)

Me-too status Rangizin XR 1000mg by M/s Macter Intr. Karachi

(Reg#076770)


compliance.”

Remarks of the Evaluator. USP/BP monograph of this formulation is not available.


Minutes for 278th





Brand Name +Dosage Form + Strength Mzapine 30mg Tablet


Composition Each Film coated tablet Contains:

Mirtazapine …..…30mg

Pharmacological Group Antidepressants (Central alpha 2 antagonist)

Type of Form Form 5


Pack size & Demanded Price 10’s 14’s,20’s, 50’s,100’s, 500’s, 1000’s (As per PRC)



Mirtazapine 30 mg Film-Coated Tablets (MHRA)

Me-too status Ramargon Lisko Pakistan


compliance.”


Decision: Approved




Brand Name +Dosage Form + Strength Mzapine 15 mg Tablet


Composition Each Film coated tablet Contains:

Mirtazapine …..…15 mg

Pharmacological Group Antidepressants (Central alpha 2 antagonist)

Type of Form Form 5


Pack size & Demanded Price 10’s 14’s,20’s, 50’s,100’s, 500’s, 1000’s (As per PRC)



Mirtazapine 15 mg Film-Coated Tablets (MHRA)

Me-too status Ramargon Lisko Pakistan


compliance.”


Decision: Approved




Brand Name +Dosage Form + Strength DRONE 100mg Tablet


Composition Each Film coated tablet contained:

Trazodone HCl……..100mg


Type of Form Form 5


Pack size & Demanded Price 10’s 14’s, 20’s, 30’s, 50’s, & 100’s (As per PRC)

Minutes for 278th




Trazodone Hydrochloride of Apotex (USFDA)

Me-too status Trozolam Lisko Pakistan


compliance.”


Decision: Approved with change of brand name.




Brand Name +Dosage Form + Strength DRONE 50 mg Tablet


Composition Each Film coated tablet contained:

Trazodone HCl……..50 mg


Type of Form Form 5


Pack size & Demanded Price 10’s 14’s, 20’s, 30’s, 50’s, & 100’s (As per PRC)



Trazodone Hydrochloride of Apotex (USFDA)

Me-too status Trozolam Lisko Pakistan


compliance.”


Decision: Approved with change of brand name.




Brand Name +Dosage Form + Strength C-PINE 100mg Tablet

Diary No. Date of R& I & fee Dy. NO.1077 , 10-01-2017, Rs: 20,000/-


Clozapine ….100mg.

Pharmacological Group Atypical antipsychotic

Type of Form Form-5


Pack size & Demanded Price 10’s, 14’s, 20’s,30’s, 50’s, & 100’ AS per PRC



CLOZAPINE of Ivex (US FDA)

Me-too status Zydex Of Genome


compliance.”


Decision: Approved with USP specifications




Brand Name +Dosage Form + Strength C-PINE 25 mg Tablet

Diary No. Date of R& I & fee Dy. NO.1076 , 10-01-2017, Rs: 20,000/-

Minutes for 278th



Clozapine ….25 mg.

Pharmacological Group Atypical antipsychotic

Type of Form Form-5


Pack size & Demanded Price 10’s, 14’s, 20’s,30’s, 50’s, & 100’ AS per PRC



CLOZAPINE of Ivex (US FDA)

Me-too status Zydex Of Genome


compliance.”


Decision: Approved with USP specifications


M/s Noa Hemis Pharmaceutical., Plot # 154, sector 23,

Korangi, kharachi

Brand Name +Dosage Form + Strength Ildren Cream 10 mg

Composition Each gram of Ildren Cream Contain:

Luliconazole …….10mg


Rs. 30,000/- 29-12-2017 (Duplicate)

Pharmacological Group Antifungal

Type of Form Form-5 D (revised from form 5)


Pack size & Demanded Price 60 g /As per Policy



Luzu (1%) of Medicis (USFDA)

Me-too status NA

GMP status Last GMP Inspection of Noa Hemis Pharmaceuticals.

Conducted on 14-6-17 with conclusive remarks of both

derive and ability to demonstrate appropriate corrective

actions.

Remarks of the Evaluator. No USP or BP monograph is available for applied

formulation.

Complete stability data

Decision: Deferred for submission of stability data as per format decided in instant meeting.


M/s Noa Hemis Plot #154, Sector 23, Korangi

industrial area Karachi.

Brand Name +Dosage Form + Strength Prego 75mg Tablet

Diary No. Date of R& I & fee Dy.184, 23-02-2015, Rs.20,000/-

Rs. 30,000/- 29-12-2017 (Duplicate)

Composition Each Film coated tablet contains:

Tapentadol (as HCl)……75 mg

Pharmacological Group Centrally acting analgesic


Finished Product Specification Manufacture

Minutes for 278th


Pack size & Demanded Price 1x10’s; 2x 10’s / As per PRC



Nucynta by Depomed (USFDA)

Me-too status NA

GMP status Last GMP Inspection of Noa Hemis

Pharmaceuticals. Conducted on 14-6-17 with

conclusive remarks of both derive and ability to

demonstrate appropriate corrective actions.



Decision: Deferred for submission of stability data as per format decided in instant

meeting.




Brand Name +Dosage Form + Strength Prego 50 mg Tablet

Diary No. Date of R& I & fee Dy. 179, 23-02-2015, Rs.20,000/-

Rs. 30,000/- 29-12-2017 (Duplicate)


Tapentadol (as HCL)……50 mg

Pharmacological Group Centrally acting analgesic



Pack size & Demanded Price 1x10’s, 2x 10’s / As per PRC



Nucynta by Depomed (USFDA)

Me-too status NA







Decision: Deferred for submission of stability data as per decision of Registration

Board.




Brand Name +Dosage Form + Strength Salifum 500mcg Tablet

Diary No. Date of R& I & fee Dy.No.181, 23-02-2015, Rs.20,000/-

Rs. 30,000/- 29-12-2017 (Duplicate)


Roflumilast…………..500 mcg

Pharmacological Group Selective phosphodiesterase 4 (PDE4) inhibitors


Minutes for 278th



Pack size & Demanded Price Form-5 (Rs.20,000/-)

10’s; 14’s; 28’s / As per PRC



Daliresp By Astrazeneca Pharms (USFDA)

Me-too status NA







Decision: Deferred for submission of stability data as per decision of Registration

Board.


M/s ATCO Laboratories Limited, B-18 SITE Karachi.

Brand Name +Dosage Form + Strength Isocort-D 0.1/1% w/w Cream

Composition Each gm contains:-

Diflucortolone valerate………… 1 mg

Isoconazole Nitrate ……………..10 mg


Pharmacological Group Anti fungal & anti inflammatory

Type of Form Form-5


Pack size & Demanded Price 5g, 10 g, 15 g, 20 g / As per SRO



Travocort cream of M/s Bayer Austria approved by

AGES of Austria

Me-too status Difzole Cream of M/s Vega Pharmaceuticals

GMP status Panel inspection conducted on 28-2-2017 and report

concludes that firm is operating at the good GMP

compliance.

Remarks of Evaluator No USP or BP monograph is available for applied

formulation.



M/s ATCO Laboratories Limited, B-18 SITE Karachi.

Brand Name +Dosage Form + Strength Isocort 1% w/w Cream

Composition Each gm contains:-

Isoconazole Nitrate ……………..10 mg


Pharmacological Group Antifungal

Type of Form Form-5


Pack size & Demanded Price 5g, 10 g, 15 g, 20 g / As per SRO



Travogen Crème of Austria

Me-too status Isocon of Valor Pharmaceuticals

Minutes for 278th


GMP status Panel inspection conducted on 28-2-2017 and report

concludes that firm is operating at the good GMP

compliance.


formulation.



M/s Hilton Pharma, Plot 13, 14, sector 15, Korangi

industrial area. Karachi

Brand Name +Dosage Form + Strength Valsan 320 mg Tablet

Composition Each Film coated tablet contains:-

Valsartan....320mg


Pharmacological Group Angiotensin-II receptor antagonist)

Type of Form Form-5


Pack size & Demanded Price 14’s; 28’s / As per SRO



Diovan by Novartis Pharmaceuticals (USFDA)

Me-too status Diovan by Novartis Pharma. Karachi

GMP status Last GMP Inspection dated 19-7-2017 with conclusive

remarks of satisfactory cGMP compliance.


Decision: Approved


M/s Hilton Pharma, Plot 13, 14, sector 15, Korangi

industrial area. Karachi

Brand Name +Dosage Form + Strength Valsan 40 mg Tablet

Composition Each film coated tablet contains:-

Valsartan....40 mg


Pharmacological Group Angiotensin-II receptor antagonist

Type of Form Form-5


Pack size & Demanded Price 14’s; 28’s/ As per SRO



Valsartan by OHM Labs Inc (USFDA)

Me-too status Valtec of Tabros Pharma


remarks of satisfactory cGMP compliance.


Decision: Approved


M/s Mafins Pharma A-5 S.I.T.E Super Highway, Karachi

Brand Name +Dosage Form + Strength Mexomin 15mg Tablet


Meloxicam ……….15mg



Type of Form Form-5

Minutes for 278th



Pack size & Demanded Price As per SRO



Mobic tablets by Boehringer

(USFDA Approved)

Me-too status Megit of Glitz Pharma


remarks of good cGMP compliance.


Decision: Approved



Brand Name +Dosage Form + Strength Esbafin 20mg Tablet


Ebastine…20mg


Pharmacological Group Anti-histamine

Type of Form Form-5





Kastine tablet approved by Netherland

Me-too status Atmos of Scotmann Pharmaceuticals




Decision: Approved



Brand Name +Dosage Form + Strength Dicmaf 75mg Tablet

Composition Each film coated sustained release tablet contains:

Diclofenac Sodium….75 mg



Type of Form Form-5





Dicloflex 75 mg SR of Dexcel Pharma UKMHRA

Me-too status ARDI [Diclofenac (Na):75mg] of English pharma




Decision: Approved

Minutes for 278th




Brand Name +Dosage Form + Strength Esbafin 10mg Tablet


Ebastine…….10mg


Pharmacological Group Anti-histamine

Type of Form Form-5





Kestine 10mg Film coated tablet by M/s Almirall

Pharmaceuticals,

(ANSM France Approved)

Me-too status Ebofor 10mg Tablet by M/s Genome Pharmaceutical




Decision: Approved



Brand Name +Dosage Form + Strength Drown 40mg Tablet

Composition Each uncoated tablet contains:

Drotaverine HCl……40 mg


Pharmacological Group Serotonin receptor antagonists/Antispasmodic

Type of Form Form-5





Approved by 3 EMA member states i.e. Poland,

Hungary, Latvia

Me-too status Draza 40mg Tablet By Opal Karachi




formulation.

Decision: Approved with innovator’s specification and change of brand name



Brand Name +Dosage Form + Strength Drown 80mg Tablet


Drotaverine HCl……80mg


Pharmacological Group Serotonin receptor antagonists/Antispasmodic

Type of Form Form-5

Minutes for 278th






Approved by 3 EMA member states i.e.Lithuania,

Hungary, Latvia.

Me-too status NO-SPA FORTE of Sanofi




formulation.

Decision: Approved with innovator’s specification and change of brand name



Brand Name +Dosage Form + Strength Flofin 400mg Tablet

Composition Each Film coating tablet contains:-

Metronidazole……400mg


Pharmacological Group Antiprotozoal and anti-bacterial

Type of Form Form-5





Flagyl tablets 400 mg (MHRA)

Me-too status Flagyl 400mg Tab. By Sanofi




Decision: Approved



Brand Name +Dosage Form + Strength M-Nol 100mg Tablet


Atenolol………..100 mg


Pharmacological Group Antihypertensive/Beta Blocker

Type of Form Form-5





Atenolol 100mg Film-Coated Tablets (MHRA)

Me-too status Adonax of Evron (Pvt) Ltd.




Decision: Approved

Minutes for 278th




Brand Name +Dosage Form + Strength Mexomin 7.5 mg Tablet


Meloxicam ……….7.5 mg



Type of Form Form-5





Mobic tablets by Boehringer

(USFDA Approved)

Me-too status Megit of Glitz Pharma




Decision: Approved



Brand Name +Dosage Form + Strength Gulofin 4mg Tablet


Glimepiride…..... 4mg


Pharmacological Group Sulphonyl urea

Type of Form Form-5





Amaryl (Sanofi Aventis US)

(FDA)

Me-too status Campride 4mg Tablet by Mendoza Reg. 067230




Decision: Approved





Glimepiride.... 3mg


Pharmacological Group Sulphonylurea

Type of Form Form-5





Amaryl of Sanofi Aventis (MHRA)

Minutes for 278th


Me-too status Amaryl of Sanofi Aventis




Decision: Approved





Glimepiride....1mg


Pharmacological Group Sulphonyl urea

Type of Form Form-5





Amaryl (Sanofi Aventis US) (FDA)

Me-too status Amaryl of Sanofi Aventis




Decision: Approved



Brand Name +Dosage Form + Strength Fluxafin 20mg Capsule

Composition Each Capsule contains:

Fluoxetine as hydrochloride…20mg


Pharmacological Group Antidepressant ( SSRI)

Type of Form Form-5





Prozac 20mg capsule by M/S Eli Lilly And Co, USFDA

approved

Me-too status Depex 20mg capsule by

minutes for 278th meeting of registration board of 278th m… · fakhrudding amar, additional...

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