|ltd.,dgftcom.nic.in/exim/2000/committee/meet_adv4_0318.pdf · 2017-11-02 · pharmaceuticals...

Government of India

Ministry of Commerce and IndustryDirectorate General of Foreign Trade

Maulana Azad Road, New Delhi 110011

Norms Committee-Ill

Para 4.7 Decision

Meeting No. 03/82/2017 of 2017-18 dated 17.05.2017 considered the cases/issues underDuty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining toChemical and Allied products falling under Chapter 29 and 30, scheduled to be held on17.05.2017 but actually held on 25.09.2017 under the Chairmanship of Shri J.V. Patil, Add).DGFT in Room No.04, Udyog Bhawan, New Delhi.

Following members were present:-

Shri Nirmal Kumar, Dy. Director General of Foreign TradeShri Arun Kumar, Consultant, Department of Pharmaceuticals.

Note:

In certain cases the decision of the Norms Committee refers to the Recommendations/

Observations / Deficiencies received from the concerned Technical authority in the samecase or a different case of another firm with the same product A scanned copy of suchdocument is placed at the end of the Minutes. In some cases, the scanned copy uploadedmay be unsigned. In both these instances, the scanned copy uploaded is to be accepted.The Committee does not approve SCOMET items and all applicants are understood.

MEETING NUMBER : 3/82-ALC4/2017 MEETING DATE : 17.05.2017

1

Case No.:60/I7/82-ALC4/2016 Party Name:MYLANLABORATORIES LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:0I/82/O50/01021/AM17/

RLA File

:09/24/040/00021/AM14/

Lic.No/Date:0910055945

07.05.2013

Defer Date:

08.11.2017

Decision : Deferred.

2

Case No.:40/l/82-ALC4/2017 Party Name:ONEIROCHEMICALS LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01394/AM17/

RLA File

:34/24/040/00066/AM 14/


03.07.2013

Defer Date:

08.11.2017

Decision: Deferred.

3

Case No.:5/17/82-ALC4/2016 iParty Name:SNF [INDIA] PVT.|ltd., Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File:01/82/050/00966/AM17/

RLA File:26/24/040/00012/AM14/


27.02.2014

Defer Date:

08.11.2017

Decision: Deferred.V

Case No.:6/5/82-ALC4/2014 Party NameiUNITED'BIOTECH PVT.LTD.

Meet No/Date:3/82-i

ALC4/2017

17.05.2017

Status:

Approved

4

HQ File:01/82/050/00323/AM15/

RLA File;05/24/040/00034/AM15/


24.04.2014

Defer Date:

Decision : The Committee decided to ratify norms on based on the recommendation of D/oPharmaceuticals O.M.No.35011/420/2014-Pl(Norms) dated June 2016 or as applied by the firmwhichever is less under para 4.07 of HBP Vol.1.RA concerned may take necessary action as perdecision of NO.

5

Case No.:61/4/82-ALC4/2014 Party NameiV & V PHARMAINDUSTRIES

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00309/AM15/

RLA File

:03/95/040/00190/AM15/


13.06.2014

Defer Date:

08.11.2017


6

Case No.:73/9/82-ALC4/2014 Party Name:D. R. COATS INK& RESINS PVT. LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00870/AM15/

RLA File

:03/94/040/00755/AM14/


30.06.2014

Defer Date:

08.11.2017

Decision: Deferred.

7

Case No.:396/5/82-ALC4/2015 Party Name:ESTEEMINDUSTRIES PVT. LTD,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00536/AM16/

RLA File

:17/24/040/00047/AM15/

Lic.No/Date.T710005887

24.07.2014

Defer Date:

08.11.2017


8

Case No.:8/6/82-ALC4/2014 Party Name:V &, V PHARMAINDUSTRIES

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File;01/82/050/00410/AM15/

RLA File

:03/95/040/00331/AM15/


28.07.2014

Defer Date:

08.11.2017

Decision: Deferred.

9

Case No.:55/13/82-

ALC4/2014

Party Name:HETERODRUGS LIMITED,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status: Approved

HQ File:01/82/050/0l058/AM15/

RLA File!:09/24/040/00269/AM15/

Lic.No/Date:0910060864'

20.08.2014Defer Date

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/36/2015-PI(Norms) dated June 2015, uploaded at the end ofthese minutes or as applied by the firm whichever Is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NO.

10

Case No.:31/9/82-ALC4/2014 Party Name:AMBERNATHORGANICS PVT. LTD.

Meet No/Date;3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File:01/82/050/00828/AM15/

RLA File

:03/94/040/00074/AM15/

Lic.No/Date;0310787610

04.08.2014

Defer Date:

08.11.2017

Decision: Deferred.

11

Case No.:2I4/13/82-

ALC4/2014

Party Name:BLlSS GVSPHARMA LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01217/AM15/

RLA File

:03/94/040/00386/AM15/


12.08.2014

Defer Date:

08.11.2017

Decision : Deferred for comment of DoP.

12

Case No.:226/13/82-

ALC4/20I4

Party NameiBLlSS GVSPHARMA LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

HQ File:01/82/050/01229/AM15/

RLA File

:03/94/040/00481/AM15/


25.08.2014

Defer Date:

Decision : The Committee decided to ratify norms on based on the recommendation of D/oPharmaceuticals O.I\/l.No.35011/30/2016-PI(Norms) dated October 2014 or as applied by the firmwhichever is less under para 4.07 of HBP Vol.1.RA concerned may take necessary action as perdecision of NC.

13

Case No.:224/13/82-

ALC4/2014

Party Name:DELTAFINOCHEM PVT.LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01227/AM15/

RLA File

:03/94/040/00391/AM15/


28.08.2014

Defer Date:

08.11.2017

Decision: Deferred.

14

Case No.:223/I3/82-

ALC4/2014

Party Name:KRISHNAANTIOXIDANTS PVT. LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01226/AM15/

RLA File

:03/94/040/00508/AM15/


02.09.2014

Defer Date:

08.11.2017


15

Case No.:400/5/82-ALC4/2015 Party Name:YASH RASAYAN& CHEMICALS

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00540/AM16/

RLA File

:34/24/040/00120/AM15/


15.09.2014

Defer Date:

08.11.2017


16

Case No.:29/13/82-ALC4/2014 Party NameJUBILANT LIFESCIENCES LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File,:01/82/050/01032/AM15/

RLA Filel

:05/23/040/00268/AM15/


08.10.2014

Defer Date:

08.11.2017

Decision : Deferred for comment of DoP.

17

Case No.: 124/13/82-

ALC4/2014

Party NameiPANACEA]BIOTEC LTD.,

Meet No/Date:3/82-i

ALC4/2017

17.05.2017

Status:

Approved '

HQ File:01/82/050/01127/AM15/

RLA File

;05/24/040/003I9/AM15/


17.10.2014

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of DBT O.M.No.BT/IL/05/316/2010-PID dated 05.06.2017, uploaded at the end of these minutes or as appliedby the firm whichever is less under para 4.07 of HBP Vol.1.RA concerned may take necessaryaction as per decision of NO.

18

Case No.:79/I/82-ALC4/2017 Party Name:R L FINE CHEM Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

HQ File;01/82/050/01433/AM17/

RLA Filei

:07/24/040/00269/AM15/


10.11.2014

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/498/2013-Pl(Norms) dated 21.11.2013, uploaded at the end ofthese minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RA'concerned may take necessary action as per decision of NC.

19

Case No.:198/5/82-ALC4/2015 Party Name:SHASUNPHARMACEUTICALS

LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00338/AMI6/

RLA Filei

;04/24/040/00205/AM15/


11.11.2014

Defer Date:,

08.11.2017

Decision: Deferred.

20

Case No.:126/8/82-ALC4/2015 Party Name:BAYERCROPSCIENCE LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00922/AM16/

RLA File;

:03/94/040/00710/AM15/

Lic.No/Date:031079117718.11.2014

Defer Date:

08.11.2017

Decision: Deferred.

21

Case No.:221/5/82-ALC4/2015 Party Name:VlVlMED LABSLIMITED

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File

:01/82/050/00361/AM16/

RLA File,

:09/24/040/00537/AM15/


23.12.2014

Defer Date:

08.11.2017

4

Decision: Deferred.

22'

Case No.:n4/5/82-ALC4/2015 Party Name:NATIONAL TUBEINDUSTRIES,

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Approved

HQ File:01/82/050/00254/AM16/

RLA File

:03/95/040/00756/AMI5/


24.12.2014

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation ofMSMEO.M.No. TU2017-GG and F-DC MSME{ChemicaI Division) dated May 2017, uploaded atthe end of these minutes or as applied by the firm whichever is less under para 4.07 of HBPVol.1.RA concerned may take necessary action as per decision of NO.

23

Case No.:2I8/S/82-ALC4/2015 Party Name:VIVIMED LABSLIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00358/AM16/

RLA File

:09/24/040/00552/AMI5/


29.12.2014

Defer Date:

08.11.2017

Decision: Deferred.

24

Case No.:80/l/82-ALC4/2017 Party NatneiR L FINE CHEM Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

HQ File:01/82/050/01434/AM17/

RLA File

:07/24/040/00331/AMI5/


31.12.2014

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/544/2014-PI(Norms) dated March 2015, uploaded at the end ofthese minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NC

25

Case No.:45/5/82-ALC4/2015 Party Name:SUVEN LIFESCIENCES LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00]85/AM16/

RLA File

:09/24/040/00558/AM15/


05.01.2015

Defer Date:

08.11.2017

Decision : The Committee decided tO' call for information from the firm based on the

recommendation of D/o Pharmaceuticals O.M.No. 35011/1/2016-PI(Norms) dated 01.06.2016,uploaded at the end of these minutes and deferred the case.

26'

Case No.:149/5/82-ALC4/2015 Party NameiALCHEMIELABORATORIES

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00289/AM16/

RLA File

:03/94/040/00813/AM15/


08.01.2015

Defer Date:

08.11.2017


27

Case No.:219/5/82-ALC4/2015 Party NameiBHAGIRADHACHEMICALS & INDUSTRIES

LIMITED

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File RLA File Lic.No/Date:0910061517 Defer Date:

:01/82/050/00359/AM16/ :09/24/040/00549/AM15/ 09.01.2015 08.11.2017


28

Case No.:88/5/82-ALC4/2015 . Party NameiABEERSPHARMACEUTICALS PVT

LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00228/AM16/

RLA File

:05/23/040/00486/AM15/


21.01.2015

Defer Date:

08.11.2017

Decision: Deferred.

29

Case No.:275/5/82-ALC4/2015'Party NameiBAYER'CROPSCIENCE LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00415/AM16/

RLA File

:03/94/040/00930/AM15/


03.02.2015

Defer Date:

08.11.2017


30

Case No.:309/5/82-ALC4/2015 Party Name:SHREEVALLABH CHEMICAL

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00449/AM16/

RLA File

:08/24/040/00417/AM15/ 1Lic.No/Date:0810134670

25.02.2015

Defer Date:'

08.11.2017


31

Case No.:61/17/82-ALC4/2016 Party Name:MYLAN'LABORATORIES LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01022/AM17/

RLA File'

:09/24/040/00607/AM15/


26.02.2015

Defer Date:

08.11.2017


32

Case No.:273/5/82-ALC4/2015 Party Name:BHARATSERUMS & VACCINES LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00413/AM16/

RLA File

:03/94/040/01055/AM15/


27.02.2015

Defer Date:

08.11.2017

Decision: Deferred.

33

Case No.:303/5/82-ALC4/2015 Party Name:ASSOCIATEDDYESTUFF PVT. LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/82/050/00443/AM16/

RLA File

:08/24/040/00422/AM15/


05.03.2015

Defer Date:

08.11.2017

Decision: Deferred.

34Case No.:300/5/82-ALC4/2015 Party Name:ADVANCE

PETROCHEMICALS

Meet No/Date:3/82-

ALC4/2017

Status:

Deferred

LIMITED 17.05.2017

HQ File:01/82/050/0D440/AM16/

RLA File

:08/24/040/00448/AM15/


11.03.2015

Defer Date:

08.11.2017


35

Case No.:447/5/82-ALC4/2015 Party NameiAARTIINDUSTRIES LIMITED

Meet No/Date:3/82-i

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:ai/82/05D/00587/AMI6/

RLA File

:03/94/040/0113l/AMI5/

Lic.No/Date:0310794543 '

12.03.2015

Defer Date:

08.11.2017

Decision: Deferred.

36

Case No.:29/5/82-ALC4/2015 Party Name:ASSOClATEDDYESTUFF PVT. LTD

Meet No/Date;3/82-'

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/OOI69/AM16/

RLA File

:08/24/040/00483/AM15/


25.03.2015

Defer Date:

08.11.2017


37

Case No.:40/8/82-ALC4/2015 Party NameiSYNTHOCHIRALS PVT. LTD

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File:01/82/05G/00836/AM16/

RLA File

:09/24/040/00042/AMI6/

Lic.No/Date:09I0061937

27.04.2015

Defer Date:

08.11.2017

Decision: Deferred.

38,

Case No.:75/8/82-ALC4/2015 Party Name:PORUSLABORATORIES PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Rejected.

HQ File:01/82/050/0087 I/AM 16/

RLA File

:09/24/040/00051/AM16/


06.05.2015

Defer Date:

Decision : The Committee based on the recommendation of D/o Pharmaceuticals O.M.No.

35011/2/2016-PI(Norms) dated 14.12.2016, upioaded at the end of these minutes, noted thatproduct to be exported and its raw material to be imported are the same drug-intermediates forMontelukast and no manufacturing activity appears to be involved. The Committee accordinglydecided to reject the case. RA concerned may take further necessary action as per decision ofNC.

39

Case No.:97/8/82-ALC4/20I5 Party , Nanie:ASCENTFINECHEM PVT. LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00893/AM16/

RLA File

;08/24/040/00051/AM16/


22.05.2015

Defer Date:

08.11.2017

Decision: Deferred.

40

Case No.:86/8/82-ALC4/2015 Party Name:VIVIMED LABSLIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00882/AM16/

RLA File

:09/24/04_0/00131/AM16/Lic.No/Date:091006209129.05.2015

Defer Date:

08.11.2017

Decision : Deferred for comments from AYUSH.

41

Case No.:187/7/82-ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:3/82-'

ALC4/2017

17.05.2017

Status:

Deferred

HQ File;01/82/050/00792/AM16/

RLA File

:08/24/040/00057/AM16/

Lic.No/Dale:0810135435

05.06.2015

Defer Date:

08.11.2017

Decision: Deferred.

42

Case No.:24/I3/82-ALC4/2016 Party Name:ARENE LIFESCIENCES LIMITED.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File':01/82/050/00652/AM17/

RLA File

:09/24/040/00034/AM16/Lic.No/Date:0910062155

10.06.2015

Defer Date:

08.11.2017

Decision: Deferred.

Case

No.: 110/8/82-

ALC4/2015

Party

Name:MAC CHEM PRODUCTS (INDIA)PRIVATE LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved |

43

HQ File,:01/82/050/00906/

AM 16/

RLA File :03/95/040/00205/AM16/ Lic.No/Date:0310796822

24.06.2015

Defer Date:

Decision : The Committee decided to ratify norms on based on the recommendation of D/oPharmaceuticals O.M.No.35011/74/2016-Pl (Norms) dated June 2016 or as applied by the firm'whichever is less under para 4.07 of HBP Vol.1.RA concerned may take necessary action as perdecision of NO.

44


Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status;

Deferred

HQ File

:01/82/050/01233/AM16/

RLA File'

:09/24/040/00186/AMI6/Lic.No/Date:0910062271

01.07.2015

Defer Date:

08.11.2017

Decision : The Committee decided to refer the case to AYUSH.

45

Case No.:108/17/82-

ALC4/2016

Party Name:GLOBALiCALCIUM PRIVATE

LIMITED,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/82/050/01069/AM17/

RLA File

:07/24/040/00112/AM16/


08.07.2015

Defer Date:

08.11.2017


46

Case No.:50/8/82-ALC4/2015 Party Name:PUSILINBIOTECHNOLOGY PVT.LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/82/050/00846/AM16/RLA File

:06/24/040/00014/AM16/Lic.No/Date:061003818909.07.2015

Defer Date:

08.11.2017


47

Case No.:54/14/82-ALC4/2015 Party Name:B10L0GlCAL ELTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/0119D/AM16/

RLA File

:09/24/040/0D524/AM15/


15.07.2015

Defer Date:

08.11.2017

Decision: Deferred.

48

Case No.:59/14/82-ALC4/2015 Party Name:B10L0GICAL ELTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01195/AM16/

RLA File

:09/24/040/0D525/AM15/


15.07.2015

Defer Date:

08.11.2017

Decision: Deferred.

49

Case No.:49/8/82-ALC4/2015 Party Name:M.L.A.INDUSTRIES

Meet No/Date:3/82-'

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00845/AM16/

RLA File

:06/24/040/00015/AM16/


16.07.2015

Defer Date:

08.11.2017

Decision: Deferred.

50

Case No.:49/14/82-ALC4/2015 Party Name:SYNTHOCHIRALS PVT. LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01185/AM16/

RLA File

:09/24/040/00205/AM16/


17.07.2015

Defer Date:

08.11.2017

Decision: Deferred.

51

Case No.:l/10/82-ALC4/2015 Party Name:SALlCYLATES &CHEMICALS PRIVATE

LIMITED

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File:01/82/05O/0a957/AM16/

RLA File

:09/24/040/OD211/AM16/


28.07.2015

Defer Date:

08.11.2017

Decision: Deferred.

52

Case No.: 131/14/82-

ALC4/2015

Party NameiSALlCYLATES &CHEMICALS PRIVATE

LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01267/AM16/

RLA File

:09/24/040/00212/AM16/


30.07.2015

Defer Date:

08.11.2017

Decision: Deferred.

53

Case No.:60/14/82-ALC4/2ai5 Party Name:PORUSLABORATORIES PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

,

HQ File:01/82/050/01196/AM16/

RLA File

:09/24/040/00256/AM16/


31.07.2015

Defer Date:

08.11.2017

Decision: Deferred.

54

Case No.:169/14/82-

ALC4/2015

Party NameiDEEPAKNOVOCHEM

TECHNOLOGIES LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01305/AMI6/

RLA Filei

:31/83/040/00018/AM16/


03.08.2015

Defer Date:

08.11.2017


55


Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/82/050/00813/AMI6/

RLA File,

:09/24/040/00251/AM16/


03.08.2015

Defer Date:

08.11.2017


56

Case No.:168/14/82-

ALC4/2015

Party Name:DEEPAK,NOVOCHEM

TECHNOLOGIES LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01304/AM16/

RLA File

:3I/83/040/00024/AM16/


04.08.2015

Defer Date:

08.11.2017


57

Case No.:18/I4/82-ALC4/2015 Party NameiMETROPOLITANEXIMCHEM PRIVATE LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01154/AM16/

RLA File

:03/95/040/00317/AMI6/

Lic.No/Date:031079803910.08.2015

Defer Date:

08.11.2017

Decision: Deferred.

Case No.:155/14/82-

ALC4/20I5

Party Name:SUNPHARMACEUTICAL

INDUSTRIES LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

58HQ File'

:01/82/050/0I291/AM16/

RLA File.

:05/24/040/00237/AM16/

Lic.No/0ate:O51039527111.08.2015

Defer Date:

08.11.2017

Decision : The Committee decided to call for information from the firm based on therecommendation of D/o Pharmaceuticals O.M.No. 35011/781/2015-PI(Norms) dated 26.04.2016,uploaded at the end of these minutes and deferred the case

59'

Case No.:ll/18/82-ALC4/2015 Party NamerSTERLINGAUXILIARIES PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:0I/82/050/01476/AM16/

RLA File

:03/95/040/00327/AM16/Lic.No/Date:031079811713.08.2015

Defer Date:

08.11.2017

Decision: Deferred.

10

60

Case No.:34/14/82-ALC4/2015 Party Name:TRANSPEKINDUSTRY LIMITED

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File:01/82/050/01170/AM16/

RLA File

:34/24/040/00144/AM16/

Lic.No/Date:34I004I464

17.08.2015

Defer Date:

08.11.2017

Decision: Deferred.

61

Case No.:56/13/82-ALC4/2015 • Party NamerPANACEABIOTEC LTD.,

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Approved

HQ File:01/82/050/01019/AM16/

RLA File

:05/24/040/00183/AM16/


18.08.2015

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of DBT O.M.NO.BT/IU05/316/2010-PID dated 05.06.2017, uploaded at the end of these minutes or as appliedby the firm whichever is less under para 4.07 of HBP Vol.1.RA concerned may take necessaryaction as per decision of NO.

62

Case No.;68/14/82-ALC4/2015 Party Name:SALICYLATES &CHEMICALS PRIVATE

LIMITED

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File:01/82/050/01204/AM16/

RLA File

:09/24/040/00368/AM15/


19.08.2015

Defer Date:

08.11.2017

Decision: Deferred.

63

Case No.:24/14/82-ALC4/2015 Party Name:SHUBHAMSPECIALTY PRODUCTS

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File:01/82/050/01160/AM16/

RLA File

:03/95/040/00348/AM16/


27.08.2015

Defer Date:

08.11.2017

Decision: Deferred.

64

Case No.:116/16/82-

ALC4/2015

Party Name:PANERA BIOTECPVT.LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File;0I/82/a50/01436/AM16/

RLA File

:O5/24/O4O/O0I81/AM16/


01.09.2015

Defer Date:

08.11.2017

Decision: Deferred.

65

Case No.:124/7/82-ALC4/2016 Party Name:AARTIINDUSTRIES LIMITED

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File:01/82/050/00298/AM17/

RLA File,

:03/94/040/00424/AMI6/


04.09.2015

Defer Date:

08.11.2017


66

Case No.:46/I4/82-ALC4/2015 Party Name:MALWAOXYGEN & INDUSTRIAL

GASES PVT.LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

11

HQ File

:01/82/050/01182/AM16/

RLA File

;56/24/040/00005/AM16/Lic.No/Date:56I0004674

09.09.2015

Defer Date:

08.11.2017

Decision: Deferred.

Case No.:72/l/82-ALC4/20I7 Party Name;R L FINE CHEM Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Approved

67

HQ File

:01/82/050/01426/AM17/

RLA File.

:07/24/040/00186/AM16/Lic.No/Date:07I010870809.09.2015

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/498/2013-PI(Norms) dated 21.11.2013. uploaded at the end ofthese minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NO.

68

Case . No.: 157/14/82-

ALC4/2015

Party Name:AETHER'INDUSTRIES LIMITED

Meet No/Date:3/82-|ALC4/20I7

17.05.2017

Status:

Deferred

HQ File

:01/82/050/01293/AMI6/

RLA File,

:52/24/040/00042/AMI6/Lic.No/Date:521004I63010.09.2015

Defer Date:

08.11.2017


69,

Case No.:35/16/82-ALC4/2015 Party Name:D. R. COATS INK& RESINS PVT. LTD.

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File':01/82/050/01355/AM16/

RLA File

:03/94/040/00415/AMI6/Lic.No/Date:031079897721.09.2015

Defer Date:

08.11.2017


Case No.:I17/14/82-

ALC4/2015

Party NameiSHASUN-PHARMACEUTICALS

LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

70HQ File

:01/82/050/01253/AM16/RLA File

:04/24/040/00I40/AM16/Lic.No/Date:0410161044

22.09.2015

Defer Date:

08.11.2017

Decision : The Committee decided to call for information from the firm based on therecommendation of D/o Pharmaceuticals O.M.No. 35011/776/2015-PI(Norms) dated June 2016,uploaded at the end of these minutes and deferred the case.

71,

Case No.:79/14/82-ALC4/2015 Party Name:ABEERSPHARMACEUTICALS PVTLTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File-

:01/82/050/01215/AM16/

RLA File

:05/23/040/00274/AM 16/Lic.No/Date:051039577330.09.2015

Defer Date:

08.11.2017

Decision: Deferred.

72'

Case Na.:69/16/82-ALC4/2015,Party Name:PIDILITE,INDUSTRIES LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File':01/82/050/01389/AMI6/

RLA File

:03/95/040/00350/AM15/Lic.No/Date:03I0799U330.09.2015

Defer Date:

08.11.2017

12

Decision: Deferred.

73)

Case No.: 139/14/82-

ALC4/2015

Party Name:MAMTAPOLYCOATS

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01275/AM16/

RLA File

:34/24/040/00178/AM16/


08.10.2015

Defer Date:

08.11.2017


74

Case No.:62/16/82-ALC4/2015 Party Name:SURVIVALTECHNOLOGIES PVT.LTD.

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File:01/82/050/01382/AM16/

RLA File

:03/95/040/00491/AM16/


08.10.2015

Defer Date:

08.11.2017

Decision: Deferred.

75

Case No.:164/14/82-

ALC4/2015

Party Name:AASHABIOCHEM

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01300/AM16/

RLA File

:10/24/040/00049/AM16/

Lic.No/Date:I010059293

12.10.2015

Defer Date:

08.11.2017

Decision: Deferred.

76

Case No.: 116/13/82-

ALC4/2016

Party Name:SOFTGELHEALTH CARE PVT. LTD.,

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File;01/82/050/00744/AM17/

RLA File

:04/24/040/00143/AM16/


20.10.2015

Defer Date:

08.11.2017


77

Case No.:72/16/82-ALC4/2015 Party Name:STERLING,AUXILIARIES PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File;01/82/050/01392/AM16/

RLA File

:03/95/040/00102/AM16/


21.10.2015

Defer Date:

08.11.2017

Decision: Deferred.

78

Case No.:73/16/82-ALC4/2015 Party Name:STERLINGAUXILIARIES PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01393/AM16/

RLA File

:03/95/040/00087/AM16/


21.10.2015

Defer Date:

08.11.2017

Decision: Deferred.

79

Case No.:29/16/82-ALC4/2015 Party Name:SALICYLATES &CHEMICALS PRIVATE

LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

13

,

HQ File:0I/82/050/01349/AM16/

RLA File'

:09/24/040/00379/AM16/


23.10.2015

Defer Date:

08.11.2017

Decision: Deferred.

o00

Case No.: 129/16/82-

ALC4/2015

Party Name: SURVIVALTECHNOLOGIES PVT.LTD. ,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File;01/82/050/01449/AM16/

RLA File*

:03/95/040/00505/AM16/


23.10.2015

Defer Date:

08.11.2017

Decision: Deferred.

81

Case No.:161/14/82-

ALC4/2015

Party NameiKAIRAVCHEMOFARBE INDUSTRIES;

LTD.

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File:01/82/050/01297/AM16/

RLA File

:03/94/040/01226/AM15/


26.10.2015

Defer Date:

08.11.2017


Case No.:31/I6/82-ALC4/2015 Party Name:MSNlLABORATORIES PRIVATE

LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

82HQ Filei:01/82/050/01351/AM16/

RLA Filei

:09/24/040/00423/AM16/


28.10.2015

Defer Date:

08.11.2017 t

Decision : The Committee decided to caii for information from the firm based on the,recommendation of D/o Pharmaceuticais O.M.No. 35011/837/2015-PI(Norms) dated 18.05.2016,uploaded at the end of these minutes and deferred the case.

83

Case No.:74/16/82-ALC4/2015 Party Name:PERFECTVITAMINS PVT.LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01394/AM16/

RLA

:03/95/040/00518/AM16/

File Lic.No/Date:0310799705

28.10.2015

Defer Date:

08.11.2017

Decision: Deferred.

84,

Case No.:75/16/82-ALC4/2015 Party Name:SURVIVAL|TECHNOLOGIES PVT.LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01395/AM16/

RLA

:03/95/040/00525/AM16/

File Lic.No/Date:0310799704

28.10.2015

Defer Date:

08.11.2017

Decision: Deferred.

85

Case No.:48/16/82-ALC4/2015 Party Name:0SPECIALITIES PVT.LTD.

C Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File!:01/82/050/01368/AM16/

RLA

:03/95/040/00549/AM16/

File' Lic.No/Date:031079987330.10.2015

Defer Date:

08.11.2017


14

86,

Case No.:159/14/82-

ALC4/2015

Party Name: SUNPHARMACEUTICAL

INDUSTRIES LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/82/050/01295/AM16/

RLA File

:05/24/040/00343/AM16/


30.10.2015

Defer Date:

08.11.2017

Decision : The Committee decided to call for Information from the firm based on therecommendation of D/o Pharmaceuticals O.M.No. 35011/781/2015-PI(Norms) dated 26.04.2016,uploaded at the end of these minutes and deferred the case.

87

Case No.:n8/16/82-

ALC4/2015


INDUSTRIES LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/82/050/01438/AM16/

RLA File.

:05/24/040/00345/AM16/


30.10.2015

Defer Date:

08.11.2017

Decision : The Committee decided to call for Information from the firm based on the

recommendation of D/o Pharmaceuticals O.M.No. 35011/781/2015-Pi{Norms) dated 26.04 2016,uploaded at the end of these minutes and deferred the case.

88

Case No.:53/16/82-ALC4/2015 Party Name:LAXMI ORGANICINDUSTRIES LTD.,

Meet No/Date:3/82-'

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/0I373/AM16/

RLA File

:03/95/040/00540/AM16/


06.11.2015

Defer Date:

08.11.2017

Decision: Deferred.

89

Case No.:89/16/82-ALC4/2015 Party Name:GULBRANDSENCHEMICALS PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

;01/82/050/0I409/AM16/

RLA File

:34/24/040/00203/AM16/

Lic.No/Date:3410D41666

09.11.2015

Defer Date:

08.11.2017

Decision: Deferred.

90

Case No.: 114/16/82-

ALC4/2015

Party Name:SHIVA BIOCHEM

INDUSTRIES

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/82/050/01434/AM16/

RLA File

:50/24/040/000I7/AM16/


16.11.2015

Defer Date:

08.11.2017


91

Case No.:4/20/82-ALC4/2015 Party Name:AIMS IMPEXPVT. LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01587/AM16/

RLA File

:03/94/040/00656/AM16/


23.11.2015

Defer Date:

08.11.2017


Case No.:31/l/82-ALCl/2016 Party Name:PAYAL Meet No/Date:3/82- Status:

92 PETROCHEM PRIVATE ALC4/2017 Deferred

LIMITED 17.05.2017

15

I■IQ File I01/82/050/0I805/AM16/ :

ILA File I05/24/040/00347/AM16/ :

.ic.No/Date:0510396399 I>3.11.2015 (

Defer Date:18.11.2017

]decision: Deferred.

Case No.:32/16/82-ALC4/2015 1̂ arty NametlNTERMED, Meet No/Date:3/82-\LC4/201717.05.2017

Status:Deferred

93 HQ File01/82/050/01352/AM16/

RLA File04/24/040/00177/AM16/

Lic.No/Date;041016I34326.11.2015

Defer Date:D8.11.2017

Decision: Deferred.

Case No.:2/l/82-ALCI/2016 ?arty NamerUNIJULES LIFESCIENCES LTD. ^

Meet No/Date:3/82-ALC4/201717.05.2017

Status:Deferred

94HQ File;:0I/82/050/01776/AM16/

RLA File;03/95/040/00632/AMI6/ !

Lic.No/Date:031080041626.11.2015

Defer Date:,08.11.2017

Decision : The Committee decided to call for information from the firm based on therecommendation of D/o Pharmaceuticals O.M.No. 35011/98/2016-PI(Norms) dated June16.02.2017, uploaded at the end of these minutes and deferred the case.

Case No.:58/20/82-ALC4/2015 ■ Party NameiNEOGENiCHEMICALS LIMITED

1

Meet No/Date:3/82-ALC4/201717.05.2017

Status:Deferred

HQ File^:0I/82/050/01641/AM16/

RLA File:03/95/040/00182/AM15/

Lic.No/Date:031080055001.12.2015


Decision: Deferred.

Case No.:3/l/82-ALCl/2016 Party Name:NEOGEN>CHEMICALS LIMITED

Meet No/Date:3/82-ALC4/201717.05.2017

Status:Deferred

96 HQ File:01/82/050/01777/AM16/

RLA File:03/95/040/00529/AM15/

Lic.No/Date:031080054701.12.2015



Case No.:5/l/82-ALCl/2016 Party Name:NEOGENCHEMICALS LIMITED

Meet No/Date:3/82-ALC4/201717.05.2017

Status:Deferred

97 HQ File:01/82/050/01779/AM16/

RLA File:03/95/040/00239/AM15/

Lic.No/Date:031080055101.12.2015



Case No.:I27/I6/82-ALC4/2015

Party Name:BLUELINEFOODS (INDIA) PVT.LTD,

Meet No/Date:3/82-ALC4/201717.05.2017

Status:Deferred

98 ■ HQ File:01/82/050/01447/AM16/

RLA File:07/24/040/00267/AM16/

Lic.No/Date:071010914608.12.2015


Decision: Deferred.

16

99'

Case No.;36/20/82-ALC4/201S Party Name:BAYER VAPIPVT.LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/016I9/AM16/

RLA File

:03/94/040/00651/AM16/


09.12.2015

Defer Date:

08.11.2017

'Decision : Deferred.

100'

Case No.:110/20/82-

ALC4/20I5

Party NametPROCESSAGROCHEM INDUSTRIES

PVT. LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01693/AM16/

RLA File,

:56/24/040/Oa040/AM16/


10.12.2015

Defer Date:

08.11.2017

Decision: Deferred.

101

Case No.:45/20/82-ALC4/2015 Party Name:KRlSHNAANTIOXIDANTS PVT. LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01628/AMI6/

RLA File

:03/94/040/00736/AM16/


14.12.2015

Defer Date:

08.11.2017

Decision: Deferred.

102

Case No.:14/20/82-ALC4/2015 Party Naine:KOPRANRESEARCH

LABORATORIES LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:0I/82/050/01597/AM16/

RLA File,

:03/94/040/00728/AM16/


21.12.2015

Defer Date:

08.11.2017

Decision : The Committee decided to call for information from the firm based on the

recommendation of D/o Pharmaceuticals O.M.No.35011/866/2015-PI(Norms) dated18.05.2016 uploaded at the end of these minutes and deferred the case.

103

Case No.:19/20/82-ALC4/2015 Party Name:LAXMIORGANIC INDUSTRIES

LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01602/AM16/

RLA File

:03/95/040/00009/AM16/


22.12.2015

Defer Date:

08.11.2017

Decision: Deferred.

104

Case No.:20/20/82-ALC4/2015 Party Name:LAXMlORGANIC INDUSTRIES

LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01603/AM16/

RLA File

:03/95/040/00267/AM16/


22.12.2015

Defer Date:

08.11.2017


105

Case No.:47/20/82-ALC4/2015 Party Name:AMINES &PLASTICIZERS LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved


17

:01/82/050/01630/AM16/ :03/94/040/00792/AM16/ 31.12.2015

Decision : The Committee decided to ratify norms based on repeat basis as per earlier decisiontaken by NO in its meeting No.18/82 dated19.12.2013, uploaded at the end of these minutes oras applied by the firm whichever is less under para 4.07 of HBP V0I.I.RA concerned may takenecessary action as per decision of NO.

Case No.:98/20/82-ALC4/2015 Party NameiFRESENIUSKABI ONCOLOGY LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

106

HQ File.:01/82/050/01681/AM16/

RLA Filei:05/23/040/00338/AM16/

Lic.No/Date:0510397164 '

31.12.2015

Defer Date:

08.11.2017

Decision : The Committee decided to call for information from the firm based on the

recommendation of D/o Pharmaceuticals O.M.No. 35011/68/2016-Pl(Norms) dated June 2016,uploaded at the end of these minutes and deferred the case.

107

Case No.:101/20/82-

ALC4/2015

Party Name:SONGWON'SPECIALTY CHEMICALS

INDIA PVT. LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01684/AM16/

RLA File

:34/24/040/00226/AM 16/


31.12.2015

Defer Date:

08.11.2017

Decision: Deferred.

108

Case No.:I19/20/82-

ALC4/2015

Party Name;SYNTHOCHIRALS PVT. LTD

Meet No/Datei3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01702/AM16/

RLA File

:09/24/040/00582/AM16/


31.12.2015

Defer Date:

08.11.2017

Decision: Deferred.

109

Case No.:104/20/82-

ALC4/2015

Party NameiBEST VALUECHEM PVT. LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01687/AM16/

RLA File

:34/24/040/00253/AM16/


04.01.2016

Defer Date:

08.11.2017

Decision: Deferred.

110

Case No.:105/20/82-

ALC4/2015

Party Name:BEST VALUECHEM PVT. LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01688/AM16/

RLA File

:34/24/040/00252/AM16/


05.01.2016

Defer Date:

08.11.2017

Decision: Deferred.

111


Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred


18

:01/82/050/01609/AM16/ |:03/94/040/00802/AM16/ 06.01.2016 08.11.2017

Decision: Deferred.

112

Case No.:7/l/82-ALCl/2016 Party Name:PRIVl ORGANICSLTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/0178I/AM16/

RLA File

:03/95/040/00688/AM16/


06.01.2016

Defer Date:

08.11.2017

Decision: Deferred.

113

Case No.:76/20/82-ALC4/2015 Party NameiAIMS IMPEXPVT. LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01659/AM16/

RLA File

:03/94/040/00790/AM16/


07.01.2016

Defer Date:

08.11.2017


114

Case No.:48/l/82-ALCl/2016 Party Name:INDO AMINESLIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01822/AM16/

RLA File

:03/94/040/00785/AM16/


12.01.2016

Defer Date:

08.11.2017

Decision: Deferred.

115

Case No.:82/l/82-ALCl/2016 Party Name:PRIVI ORGANICSLTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01856/AM16/

RLA File

:03/95/040/0069Q/AM16/


12.01.2016

Defer Date:

08.11.2017

Decision: Deferred.

116

Case No.:66/l/82-ALCl/2016 Party Name:BTL EXPORTSPVT. LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File;01/82/050/01840/AM16/

RLA File

:03/94/040/00831/AM16/


18.01.2016

Defer Date:

08.11.2017

Decision: Deferred.

117

Case No.:79/I/82-ALCI/2016 Party Name:PRIVI ORGANICSLTD

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File:01/82/050/01853/AM16/

RLA File

:03/95/040/0a689/AM16/


18.01.2016

Defer Date:

08.11.2017

Decision: Deferred.

118Case No.;lI4/20/82-

ALC4/20I5

Party Name:GULBRANDSENCHEMICALS PVT LTD

Meet No/Date:3/82-

ALC4/2017

Status:

Deferred

19

17.05.2017

HQ File:01/82/050/01697/AM16/

RLA File;:34/24/040/00263/AM16/


19.01.2016

Defer Date:

08.11.2017


119

Case No.:50/l/82-ALCl/2016 Party Name:AMINES &PLASTICIZERS LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File,:01/82/050/01824/AM16/

RLA File.

:03/94/040/0D861/AM16/


20.01.2016

Defer Date:

08.11.2017


120

Case No.:68/l/82-ALCl/2016

1

Party Name:BTL EXPORTS'PVT. LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01842/AM16/

RLA File

:03/94/040/00834/AM16/


20.01.2016

Defer Date:

08.11.2017

Decision: Deferred.

121

Case No.:106/20/82-

ALC4/2015

Party Name;MOREPENiLABORATORIES LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01689/AM16/

RLA File

:05/24/040/00515/AM16/


20.01.2016

Defer Date:

08.11.2017 '

Decision : The Committee decided to call for Information from the firm based on the'recommendation of D/o Pharmaceuticals O.M.No. 35011/4/2016-PI(Norms) dated 1.6.2016,uploaded at the end of these minutes and deferred the case.

122,

Case No.:38/l/82-ALCl/2016 Party Name:SURVIVALTECHNOLOGIES PVT.LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File,:01/82/050/01812/AM16/

RLA File:

;03/95/040/00798/AM16/


20.01.2016

Defer Date:

08.11.2017

Decision: Deferred.

123

Case No.:49/l/82-ALCl/2016 Party Name:AMINES &PLASTICIZERS LIMITED

Meet . No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01823/AM16/

RLA File.

:03/94/040/00869/AM16/


21.01.2016

Defer Date:

08.11.2017

Decision: Deferred.

124

Case No.;72/7/82-ALC4/2016 Party Name:OGENESYSTEMS INDIA LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00246/AM17/

RLA File'

:09/24/040/00620/AM16/


22.01.2016

Defer Date:

08.11.2017

20

Decision: Deferred.

125

Case No.:27/l/82-ALCl/2016 Party Name:BODALCHEMICALS LTD

Meet No/Date:3/82-'ALC4/2017

17.05.2017

Status:

Deferred

HQ File;01/82/050/01801/AM16/

RLA File

:08/24/040/00325/AM16/


01.02.2016

Defer Date:

08.11.2017


126

Case No.:40/l/82-ALCl/2016 Party NameiMAGNOLIALIMITED.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/ai814/AM16/

RLA File

:03/95/040/01074/AMI5/


02.02.2016

Defer Date:

08.11.2017

Decision: Deferred.

127

Case No.:37/I/82-ALCl/2016 Party Name:STERLINGAUXILIARIES PVTLTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:0I/82/050/0]811/AM16/

RLA File,:03/95/040/00639/AM16/


04.02.2016

Defer Date:

08.11.2017

Decision: Deferred.

128

Case No.:43/l/82-ALCl/2016 Party Name:AARTIINDUSTRIES LIMITED

Meet No/Date:3/82-'

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01817/AM16/

RLA File

:03/94/040/00882/AM16/


05.02.2016

Defer Date:

08.11.2017

Decision: Deferred.

129

Case No.:69/l/82-ALCl/2016 Party Name:ENCUBEETHICALS PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01843/AM16/

RLA File

:03/94/040/00922/AM16/


08.02.2016

Defer Date:

08.11.2017

Decision: Deferred.

130

Case No.:39/l/82-ALCl/2016 Party NameiPERFECTVITAMINS PVT.LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01813/AM16/

RLA File

:03/95/040/a0847/AM16/


08.02.2016

Defer Date:

08.11.2017

Decision: Deferred.

131

Case No.:45/I/82-ALCl/2016 Party Name:KAlRAVCHEMOFARBE INDUSTRIES

LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

21

HQ File]:01/82/050/018I9/AM16/

RLA File

:03/94/040/00859/AM16/


09.02.2016

Defer Date:

08.11.2017


Case No.:79/7/82-ALC4/2016

1

Party Name:OPTIMUS

DRUGS PRIVATE LIMITED :

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

132HQ Filei:01/82/050/00253/AM17/

RLA File'

:09/24/040/00586/AM16/


10.02.2016

Defer Date:

08.11.2017 .

Decision : The Committee decided to call for information based on the recommendation of D/oPharmaceuticals O.M.No. 35011/138/2016-PI(Norms) dated August 2016, uploaded at the end ofthese minutes and deferred the case.

133

Case No.:41/l/82-ALCl/2016 Party Name:STERLING|AUXILIARIES PVT LTD

Meet No/Date:3/82-|

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01815/AM16/ '

RLA Filei

:03/95/040/00826/AM16/


10.02.2016

Defer Date:

08.11.2017

Decision: Deferred.

134

Case No.:78/l/82-ALCI/2016 Party NameiSTERLING'AUXILIARIES PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File-:01/82/050/01852/AM16/ 1

RLA Filel

:03/95/040/00752/AM16/ 1Lic.No/Date:0310802451

10.02.2016

Defer Date:|08.11.2017

Decision: Deferred.

135

Case No.:26/l/82-ALCl/20I6 Party Name:UMAENTERPRISE

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01800/AM16/

RLA File

:08/24/040/00396/AM16/


15.02.2016

Defer Date:

08.11.2017


Case No.:56/l/82-ALCl/2016 Party Name:ZIMiLABORATORIES LTD.

1

Meet No/Date:3/82-'

ALC4/2017

17.05.2017

Status:

Deferred

136,HQ File

:01/82/050/01830/AM16/

RLA File

:03/95/040/00887/AM16/


16.02.2016

Defer Date:

08.11.2017

Decision : The Committee decided to call for information based on the recommendation of D/oPharmaceuticals O.M.No. 35011/28/2016-PI(Norms) dated August 2016, uploaded at the end ofthese minutes and deferred the case.

137

Case No.:17/l/82-ALCl/2016 Party Name:ARJUNCHEMICALS PVT. LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File'

;01/82/050/0l791/AM16/

RLA File;

:04/24/040/00229/AM16/ 1Lic.No/Date:0410161613

17.02.2016

Defer Date:

08.11.2017

22

Decision: Deferred.

138

Case No.:82/7/82-ALC4/2016 Party Name:OPTIMUSDRUGS PRIVATE LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00256/AM17/

RLA File

:09/24/040/00721/AM16/


03.03.2016

Defer Date:

08.11.2017

Decision: Deferred.

139

Case No.:59/7/82-ALC4/2016 Party Name:RUCHI SOYAINDUSTRIES LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/a0233/AM17/

RLA File

:56/24/040/00054/AM16/


11.03.2016

Defer Date:

08.11.2017

Decision: Deferred.

140

Case No.:24/2/82-ALC4/2016 Party Name:SCOPECHEMICALS PRIVATE

LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00024/AM17/

RLA File

:03/95/040/00955/AM16/


11.03.2016

Defer Date:

08.11.2017

Decision: Deferred.

141

Case No.:15/l/82-ALCl/2016 Party Name:COVALENTLABORATORIES PRIVATE,

LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

HQ File:01/82/050/01789/AM16/

RLA File

:09/24/040/00713/AM16/


15.03.2016

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/241/2016-PI(Norms) dated 19.09.2017, uploaded at the end ofthese minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NO.

142

Case No.:109/7/82-ALC4/2016 Party Nanie:BEST VALUECHEM PVT. LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00283/AM17/

RLA File

:34/24/040/00336/AM16/


21.03.2016

Defer Date:

08.11.2017

Decision: Deferred.

143

Case No.:138/7/82-ALC4/2016 Party Name:ALTALABORATORIES LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00312/AMI7/

RLA File

:03/94/040/01112/AM16/


01.04.2016

Defer Date:

08.11.2017

Decision: Deferred.

|l44 Case No.:24/7/82-ALC4/2016 Party Name: DEEPAK Meet No/Date:3/82- Status:

23

NOVOCHEM

TECHNOLOGIES LTDALC4/20I7

17.05.2017

Deferred

HQ File

:01/82/050/00198/AM17/

RLA File

:31/83/040/00186/AM16/Lic.No/Date:311006611105.04.2016

Defer Date:

08.11.2017


.

145

Case No.:123/7/82-ALC4/2016 Party Name:AARTIINDUSTRIES LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/82/050/00297/AM17/

RLA File

:03/94/040/01038/AM16/Lic.No/Date;031080381906.04.2016

Defer Date:

08.11.2017 •

Decision: Deferred.

146

Case No.:45/7/82-ALC4/2016 Party Name:ASTRALSTERITECH PVT. LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File'

:01/82/050/00219/AM17/ 'RLA File'

:34/24/040/00009/AM17/Lic.No/Date:3410042064

13.04.2016 !Defer Date:

08.11.2017

Decision: Deferred.

147

Case No.:50/7/82-ALC4/2016 Party Name:BODALCHEMICALS LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:0]/82/050/00224/AM17/RLA Filei

:08/24/040/00005/AM17/Lic.No/Date:0810137692 '18.04.2016

Defer Date:

08.11.2017


148

CaseNo.:15/7/82-ALC4/2016 > Party Narae:SUPREETCHEMICALS PVT.LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/82/050/00189/AM17/RLA File

:52/24/040/00006/AM17/Lic.No/Date:521004186925.04.2016

Defer Date:

08.11.2017

Decision: Deferred.

149'

Case No.:148/7/82-ALC4/2016 Party Name:HEMA DYE'CHEM PVT. LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/82/050/00322/AM17/RLA File

:03/94/040/00055/AM17/Lic.No/Date:031080421126.04.2016

Defer Date:

08.11.2017

Decision: Deferred.

Case No.:49/7/82-ALC4/2016 Party NamerPANACEABIOTEC LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

150 HQ File.

01/82/q50/00223/AM17/RLA File

05/24/040/00009/AM17/Lic.No/Date:051039839205.05.2016

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of DBT O.M.^o.BT/IL/05/316/2010-PID dated 05.06.2017, uploaded at the end of these minutes or as applied

24

by the firm whichever is less under para 4.07 of HBP Vol.1.RA concerned may take necessaryaction as per decision of NC.

151

Case No.:8/7/82-ALC4/2016 Party Name: STRIDESSHASUN LIMITED

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File:01/82/050/00182/AM17/

RLA File

:04/24/040/00009/AM17/


05.05.2016

Defer Date:

08.11.2017

Decision : The Committee decided to call for information based on the recommendation of D/o

Pharmaceuticals O.M.No. 35011/154/2016-PI(Norms) dated Sept 2016, uploaded at the end ofthese minutesand deferred the case.

152

Case No.:9/7/82-ALC4/2016 Party Name:STRlDESSHASUN LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00183/AM17/

RLA File

:04/24/040/00010/AM17/


05.05.2016

Defer Date:

08.11.2017

Decision :The Committee decided to call for information based on the recommendation of D/o

Pharmaceuticals O.M.No. 35011/154/2016-PI(Norms) dated Sept. 2016, uploaded at the end ofthese minutes and deferred the case.

153

Case No.:163/7/82-ALC4/2016 Party Name:AMINES &'PLASTICIZERS LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File;01/82/050/00337/AM17/

RLA File

:03/94/040/00090/AM17/


09.05.2016

Defer Date:

08.11.2017


154

Case No.:18/7/82-ALC4/2016 Party Name:CONTlNENTALCHEMICALS

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File:01/82/050/00192/AM17/

RLA File

:08/24/040/00044/AM17/


09.05.2016

Defer Date:

08.11.2017


'155

Case No.:51/7/82-ALC4/2016 Party NameiJUBILANT LIFESCIENCES LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00225/AM17/

RLA File

:05/23/040/00539/AM16/


09.05.2016

Defer Date:

08.11.2017

Decision: Deferred.

156

Case No.:159/7/82-ALC4/2016 Party Name:BLUE CIRCLEORGANICS PVT. LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00333/AM17/

RLA File

:03/94/040/00061/AM17/


10.05.2016

Defer Date:

08.11.2017

25

Decision: Deferred.

157'

Case No.:160/7/82-ALC4/2016 Party Name:BLUE CIRCLEORGANICS PVT. LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ Filci:01/82/050/00334/AM17/

RLA File,

:03/94/040/00036/AM17/


10.05.2016

Defer Date:

08.11.2017

Decision: Deferred.

Case No.:76/7/82-ALC4/2016 Party NameiFRESENIUS'KABI ONCOLOGY LIMITED i

Meet No/Date:3/82-,

ALC4/2017

17.05.2017

Status:

Deferred

158HQ File:01/82/050/00250/AM17/

RLA File.

:05/23/040/00031/AM17/


10.05.2016

Defer Date:

08.11.2017

Decision : The Committee decided to call for Information based on the recommendation of D/o'

Pharmaceuticals O.M.No. 35011/200/2016-PI(Norms) dated August 2016, uploaded at the end ofthese minutes and deferred the case.

159

Case No.:137/7/82-ALC4/2016 Party Name:RELIANCE'INDUSTRIES LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00311/AM17/

RLA File

:03/95/040/00763/AM16/


10.05.2016

Defer Date:

08.11.2017

Decision: Deferred.

160

Case No.:157/7/82-ALC4/2016 Party Name:APEX PHARMA, Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File.:01/82/050/00331/AM17/

RLA File]

:03/94/040/00122/AM17/


12.05.2016

Defer Date:'

08.11.2017

Decision: Deferred.

161

Case No.:86/ll/82-ALC4/2016 Party Name:ALMELO'PRIVATE LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00620/AM17/

RLA File

:09/24/040/00056/AM17/


17.05.2016

Defer Date:

08.11.2017


Case No.:85/ll/82-ALC4/2016,Party Name:COVALENTLABORATORIES PRIVATE

LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

162

HQ File

:01/82/050/0a619/AM17/

RLA File

;09/24/040/00028/AM17/


17.05.2016

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/o'Pharmaceuticals O.M.No. 35011/241/2016-PI(Norms) dated 19.09.2017, uploaded at the end ofthese minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NC.

26

163'

Case No.:71/17/82-ALC4/2016 Party Name:GLOBALCALCIUM PRIVATE

LIMITED,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01032/AM17/

RLA File

:07/24/040/00385/AM16/


17.05.2016

Defer Date:

08.11.2017


164

Case No.:82/ll/82-ALC4/2016 Party Name:SENTlSSPHARMA PVT.LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

HQ File:01/82/050/00616/AM17/

RLA File,

:05/24/040/00624/AMI6/


17.05.2016

Defer Date:


165

Case No.:83/ll/82-ALC4/2016 Party NameiBIOLOGICAL ELTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00617/AM17/

RLA File

:09/24/040/00307/AM15/


19.05.2016

Defer Date:

08.11.2017


166

Case No.:139/7/82-ALC4/2016 Party Name:GANGWALCHEMICALS (P) LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00313/AM17/

RLA File

:03/94/040/00149/AM17/


23.05.2016

Defer Date:

08.11.2017

Decision: Deferred.

167

Case No,:140/7/82-ALC4/2016 Party Name:GANGWALCHEMICALS (P) LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00314/AM17/

RLA File

:03/94/040/00148/AM17/


23.05.2016

Defer Date:

08.11.2017

Decision: Deferred.

168

Case No.:153/7/82-ALC4/2016 Party Name:BAYERCROPSCIENCE LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00327/AM17/

RLA File

:03/94/040/00115/AM17/


24.05.2016

Defer Date:

08.11.2017


|l69|CaseNo.:134/7/82-ALC4/2016 |Party Name:ORBIT LIFE Meet No/Date:3/82- Status:

27

SCIENCE PVT. LTD. ALC4/20I7

17.05.2017

Deferred

HQ File:01/82/050/00308/AM17/

RLA File

:03/95/040/00069/AM17/


24.05.2016

Defer Date:

08.11.2017

Decision : The Committee decided to call for information based on the recommendation of D/o

Pharmaceuticals O.M.No. 35011/145/2016-PI(Norms) dated July, 2016, uploaded at the end ofthese minutes and deferred the case.

170

Case No.:43/10/82-ALC4/2016'

1

Party NameiO CSPECIALITIES PVT.LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File,:01/82/050/00389/AM17/

RLA File

:03/95/040/00I69/AMI7/


01.06.2016

Defer Date:'

08.11.2017

Decision: Deferred.

171

Case No.:2/ll/82-ALC4/2016 Party NameiMANALPPETROCHEMICALS

LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00536/AM17/

RLA File

:04/24/040/00270/AM 16/


02.06.2016

Defer Date:

08.11.2017

Decision: Deferred.

Case No.:8/U/82-ALC4/2016 Party Name:SOFTGEL'HEALTH CARE PVT. LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved ,

172

HQ File:01/82/050/00542/AM17/

RLA File

:04/24/040/00042/AM 17/


03.06.2016

Defer Date:

•

Decision : The Committee decided to ratify norms based on the recommendation of D/o'Pharmaceuticals O.M.No. 35011/382/2016-PI(Norms) dated 12.09.2017, uploaded at the end ofthese minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RA,concerned may take necessary action as per decision of NC.

173

Case No.:61/11/82-ALC4/2016'1

Party NameiKEKULE:PHARMA LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File':01/82/050/00595/AM17/

RLA File'

:09/24/040/00017/AM17/

Uc.No/Date:091006378I

09.06.2016

Defer Date:

08.11.2017

Decision: Deferred.

, 174

Case No.:29/13/82-ALC4/2016 Party Name:KUTCH'CHEMICAL INDUSTRIES

LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00657/AM17/

RLA File

:34/24/040/00068/AM17/


10.06.2016

Defer Date:

08.11.2017

Decision: Deferred.

175

Case No.:62/ll/82-ALC4/20I6 Party Name:SALICYLATES &CHEMICALS PRIVATE

LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

28

HQ File:01/82/050/00596/AM17/

RLA File

:09/24/040/00077/AM17/


10.06.2016

Defer Date:

08.II.20I7

Decision: Deferred.

176

Case No.:64/ll/82-ALC4/2016 Party NameiSALICYLATES &

CHEMICALS PRIVATE

LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/82/050/a0598/AMI7/

RLA File

:09/24/040/00076/AM17/


10.06.2016

Defer Date:

08.11.2017


177

Case No.:89/13/82-ALC4/2016 Party Name:UMAENTERPRISE

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00717/AMI7/

RLA File

;08/24/040/00099/AM17/


10.06.2016

Defer Date:

08.11.2017


178

Case No.:5/ll/82-ALC4/2016 Party Name:ASCENTFINECHEM PVT. LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00539/AM17/

RLA File

:08/24/040/OOI04/AM17/


28.06.2016

Defer Date:

08.11.2017


179

Case No.:16/ll/82-ALC4/2016 Party Name:PERFECTVITAMINS PVT.LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/aD550/AM17/

RLA File

:03/95/040/00255/AMI7/


29.06.2016

Defer Date:

08.11.2017

Decision: Deferred.

180

Case No.:198/17/82-

ALC4/2016

Party Name:NASENSE LABSPVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01159/AMI7/

RLA File

:09/24/040/00172/AMI7/


30.06.2016

Defer Date:

08.11.2017

Decision: Deferred.

181

Case No.:7/ll/82-ALC4/2016 Party Name:PANERA BIOTECPVT.LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/82/050/0D541/AM17/

RLA File

:05/24/040/00136/AM17/


30.06.2016

Defer Date:

08.11.2017

Decision: Deferred.

|182 |Case No.:185/17/82- |Party NameiAUROBINDO Meet No/Date:3/82- Status:

29

ALC4/20I6 PHARMA LIMITED ALC4/2017

17.05.2017

Deferred

HQ File]:01/82/050/01146/AM17/

RLA File,:09/24/040/00147/AM17/


04.07.2016

Defer Date:

08.11.2017

Decision: Deferred.

Case No.:14/ll/82-ALC4/2016 Party Name:PALADIN'PAINTS AND CHEMICALS ■PVT. LTD.,

Meet No/Date;3/82-ALC4/20I7

17.05.2017

Status:

Deferred

183 HQ File:01/82/050/00548/AM17/

RLA File:03/95/040/00277/AM17/


04.07.2016

Defer Date:;08.11.2017 ■

Decision: Deferred.

<:ase No.:48/n/82-ALC4/2ai6' I'i

I

'arty Name:J.B. CHEMICALSI Ifc PHARMACEUTICALS i

JMITED

vieet No/Date:3/82- S\LC4/2017 I

7.05.2017

>tatu$:

)eferred

1

184

-IQ File 101/82/050/00582/AM17/

ILA Filei 103/94/040/00255/AM17/ (

.ic.No/Date:0310805960 I

35.07.2016 (

Defer Date;'

38.11.2017

Decision : The Committee decided to call for information from the firm based on therecommendation of D/o Pharmaceuticals forwarded O.M.No.35011/344/2016-PI(Norms)dated 3.4.2017 uploaded at the end of these minutes and deferred the case.

Case No.:3/13/82-ALC4/2016 Party Name:SUN'PHARMACEUTICAL

INDUSTRIES LTD.,

VIeet No/Date:3/82-ALC4/2017

17.05.2017

Status:

Deferred

185 HQ File!:01/82/050/00631/AM17/ I

RLA File];05/24/040/00143/AM17/


06.07.2016 :

Defer Date:'

08.11.2017

Decision: Deferred.

Case No.:13/ll/82-ALC4/2016 Party Name:S M CHEMICAL]VAPl PRIVATE LIMITED

Meet No/Date:3/82-ALC4/2017

17.05.2017

Status:

Deferred

186 HQ File:01/82/050/00547/AM17/

RLA File!:03/95/040/00225/AM17/


11.07.2016

Defer Date:

08.11.2017

Decision: Deferred.

Case No.:42/ll/82-ALC4/2D16 Party Name:AARTIINDUSTRIES LIMITED


17.05.2017

Status:

Deferred

187 HQ File:01/82/050/00576/AM17/

RLA File:03/94/040/00198/AM17/


12.07.2016

Defer Date:

08.11.2017

Decision: Deferred.

-

188

Case No.:52/ll/82-ALC4/2016 Party Name:J.B. CHEMICALS& PHARMACEUTICALS

LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

HQ File:01/82/050/00586/AM17/

RLA File:03/94/040/00288/AM17/

Lic.No/Date:03l0806I13

12.07.2016

Defer Date:

30


189'

Case No.:32/13/82-ALC4/2016 Party Name:J.B. CHEMICALS& PHARMACEUTICALS

LIMITED

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Approved

HQ File:01/82/050/0D660/AM17/

RLA File

:03/94/040/00291/AMI7/


12.07.2016

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/379/2016-PI(Norms) dated 14.09.2017, uploaded at the end ofthese minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NC.

190

Case No.:89/ll/82-ALC4/2016 Party Name:MALWAOXYGEN & INDUSTRIAL

GASES PVT.LTD.,

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File:01/82/050/00623/AMI7/

RLA File

:56/24/040/000I5/AM17/


12.07.2016

Defer Date:

08.II.20I7

Decision: Deferred.

191

Case No.:10/ll/82-ALC4/2016 Party Name:MATRlX FINE

SCIENCES PVT.LTD.,Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File:01/82/050/00544/AM17/

RLA File

:03/95/040/00304/AM17/


14.07.2016

Defer Date:

08.11.2017

Decision: Deferred.

192'

Case No.:56/n/82-ALC4/2016 Party Name:NEOGENCHEMICALS LIMITED

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File:01/82/050/0D590/AM17/

RLA File

:03/95/040/00746/AMI6/


14.07.2016

Defer Date:

08.II.20I7

Decision: Deferred.

193

Case No.:67/ll/82-ALC4/2016 Party Name:FRESENIUS.

KABI ONCOLOGY LIMITED

Meet No/Date:3/82-i

ALC4/2017

17.05.2017

Status:

Approved

HQ File:01/82/050/00601/AM17/

RLA File

:05/23/040/00065/AMI7/


19.07.2016

Defer Date:


194

Case No.:66/ll/82-ALC4/2016 Party Name:JUBILANT LIFE

SCIENCES LIMITED

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

31

HQ File;01/82/050/00600/AM17/

RLA File,:05/23/040/00147/AM17/

Lic.No/Date:0510399I30 '

19.07.2016

Defer Date:

08.11.2017


195

Case No.:21/ll/82-ALC4/2016 Party Name:NEOGENCHEMICALS LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File;:01/82/050/00555/AM17/

RLA File

:03/95/040/00206/AM17/

Lic.No/Date:0310806373 i

19.07.2016

Defer Date:;

08.11.2017 '

Decision: Deferred.

196

Case No.: 18/11/82-ALC4/2016 Party Name:RESONANCESPECIALTIES LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/OD552/AM17/

RLA Filei

:03/95/040/00262/AMI7/


19.07.2016

Defer Date:

08.11.2017

Decision: Deferred.

197

Case No.:35/ll/82-ALC4/2016 Party NameiAARTI'INDUSTRIES LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00569/AM17/

RLA File

:03/94/040/00283/AM17/


20.07.2016

Defer Date:

08.11.2017

Decision: Deferred.

198

Case No.:74/ll/82-ALC4/2016 Party Name:KLJ'PLASTICIZERS LIMITED

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File:01/82/050/00608/AM17/

RLA Filei

:05/23/040/00195/AM17/


20.07.2016

Defer Date:

08.11.2017

Decision: Deferred.

Case No.:19/ll/82-ALC4/2016 Party NaraeiREANNONPHARMACEUTICALS

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

\99-

HQ File:01/82/050/00553/AM17/

RLA Filei

:03/95/040/00326/AM17/


21.07.2016

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/315/2016-PI(Norms) dated 5.09.2017, uploaded at the end of,these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NO.

200

Case No.:83/13/82-ALC4/2016 Party NameiREANNONPHARMACEUTICALS

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00711/AMI7/

RLA File

:03/95/040/00327/AM17/ ;Lic.No/Date:0310806482

21.07.2016

Defer Date:.

08.11.2017

Decision: Deferred.

32

201

Case No.:25/ll/82-ALC4/2016 Party NameiSTERLlNGAUXILIARIES PVT LTD

Meet No/Datei3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File;01/82/050/00559/AMI7/

RLA File

:03/95/040/00180/AM17/

Lic.No/Datei0310806477

21.07.2016

Defer Date:

08.11.2017

Decision: Deferred.

202


Meet No/Date:3/82-i

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00560/AM17/

RLA File

103/95/040/00116/AM17/


21.07.2016

Defer Date:

08.11.2017


203


Meet No/Date:3/82-'

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00561/AM17/

RLA File

:03/95/040/00143/AM17/


21.07.2016

Defer Date:

08.11.2017

Decision: Deferred.

204

Case No.:20/13/82-ALC4/2016 Party NameiFRESENIUSKABI ONCOLOGY LIMITED

Meet No/Datei3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00648/AM17/

RLA File

105/23/040/00211/AM17/


22.07.2016

Defer Date:

08.11.2017


205

Case No.:20/ll/82-ALC4/2016 Party NameiNEOGENCHEMICALS LIMITED

Meet No/Datei3/82-'

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00554/AM17/

RLA File

I03/95/040/00498/AM16/


22.07.2016

Defer Date:

08.11.2017

Decision: Deferred.

206

Case No.:3I/ll/82-ALC4/2016 Party NameiSTERLlNG,AUXILIARIES PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00565/AM17/

RLA File

103/95/040/00168/AM17/


22.07.2016

Defer Date:

08.11.2017


207

Case No.:7/13/82-ALC4/2016 Party NameiSTYRAXPHARMA PRIVATE

LIMITED

Meet No/Datei3/82-

ALC4/2017

17.05.2017

Status:

Approved

HQ File:01/82/050/00635/AM17/

RLA File

I26/24/040/00013/AM17/


22.07.2016

Defer Date:

33

Decision : The Committee decided to ratify norms based on the recommendation of D/o,Pharmaceuticals O.M.No. 35011/357/2016-PI{Norms) dated 31.08.2017, uploaded at the end ofthese minutes or as applied by the firm whichever Is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NO.

208

Case No.:70/11/82-ALC4/2016,Party NameiARCHI EXIM,PVT. LTD.

Meet No/Date:3/82-i

ALC4/2017

17.05.2017

Status:

Deferred

HQ File^:01/82/050/00604/AM17/

RLA File

:08/24/040/00150/AMI7/


25.07.2016

Defer Date:

08.11.2017

Decision: Deferred.

209

Case No.:71/l 1/82-ALC4/2016,Party Name:ARCHI EXIMlPVT. LTD.

Meet No/Date:3/82-'

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00605/AM17/

RLA File

:08/24/040/00151/AM17/


25.07.2016

Defer Date:

08.11.2017


Case No.:144/13/82-

ALC4/2016

Party Name:CADILAHEALTHCARE LTD

Meet No/Date:3/82-i

ALC4/2017

17.05.2017

Status:

Approved

210

HQ File::01/82/050/00772/AMI7/

RLA File

:08/24/040/00154/AM17/


25.07.2016

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/374/2016-PI(Norms) dated 08.09.2017, uploaded at the end ofthese minutes or as applied by the firm whichever Is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NC.

211

Case No.:32/ll/82-ALC4/2016 ■

1

Party NameiSTERLING.AUXILIARIES PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00566/AM17/

RLA File'

:03/95/040/00290/AM17/


25.07.2016

Defer Date:

08.11.2017


212

Case No.:55/ll/82-ALC4/2016^ Party Name:SWISSPARENTERALS PVT.LTD.

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ Filci:0I/82/050/00589/AMI7/

RLA File:

:08/24/040/00156/AM17/


25.07.2016

Defer Date:

08.11.2017


213'

Case No.:22/ll/82-ALC4/2016 Party NameiENCUBEETHICALS PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status;

Approved

HQ File;

:01/82/050/00556/AM17/

RLA File

:03/94/040/00262/AM17/Lic.No/Date:0310806600 '

26.07.2016Defer Date: ,

34


214

Case No.:77/ll/82-ALC4/2016 Party NameiASIATIC DRUGS&PHARMACEUT1CALS PVT.

LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:OI/82/050/00611/AM17/

RLA File

:05/23/040/00124/AM17/


27.07.2016

Defer Date:

08.11.2017


215

Case No.:78/ll/82-ALC4/2016 Party Name:ASIATIC DRUGS.fePHARMACEUTICALS PVT.

LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File':01/82/050/00612/AM17/

RLA File

:05/23/040/00123/AM17/


27.07.2016

Defer Date:

08.11.2017

Decision: Deferred.

216

Case No.:79/ll/82-ALC4/2016 Party Name:ASlATIC DRUGS&PHARMACEUTICALS PVT.

LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00613/AM17/

RLA File

:05/23/040/00119/AM17/


27.07.2016

Defer Date:

08.11.2017


217

Case No.:80/ll/82-ALC4/2016 Party Name:ASIATIC DRUGS&PHARMACEUTICALS PVT.

LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File;01/82/050/00614/AM17/

RLA File

;05/23/040/00125/AM17/


27.07.2016

Defer Date:

08.11.2017

Decision: Deferred.

218

Case No.:67/I3/82-ALC4/2016 Party Name:BDRPHARMACEUTICALS

INTERNATIONAL PVT. LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

HQ File:01/82/050/00695/AM17/

RLA File

:03/94/040/00335/AM17/


27.07.2016

Defer Date:


219

Case No.:84/13/82-ALC4/2016 Party Name:PAYALPETROCHEM PRIVATE

LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00712/AM17/

RLA File

;05/24/040/00I70/AM17/


27.07.2016

Defer Date:

08.11.2017

35


220

Case No.:64/13/82-ALC4/20I6,Party Name:AARTlINDUSTRIES LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File.:01/82/050/00692/AM17/

RLA File

;03/94/040/00177/AM17/


28.07.2016

Defer Date:

08.11.2017

Decision: Deferred.

221

Case No.:112/17/82-

ALC4/20I6

Party Name:GLOBALCALCIUM PRIVATE'

LIMITED,

Meet No/Date:3/82-'

ALC4/2017

17.05.2017

Status:

Deferred

HQ File.:01/82/050/01073/AMI7/

RLA File

:07/24/04O/00I53/AMI7/


04.08.2016

Defer Date:

08.11.2017


222

Case No,:50/13/82-ALC4/2016 Party Name:DELTA,FINOCHEM PVT.LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/82/050/00678/AM17/

RLA File'

:03/94/040/00286/AM17/


09.08.2016

Defer Date:

08.11.2017


223

Case No.:10/13/82-ALC4/2016 Party Name:FRESENIUS'KABI ONCOLOGY LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00638/AM17/

RLA File,

:05/23/040/00229/AM17/


09.08.2016

Defer Date:

08.11.2017

Decision: Deferred.

Case No.:26/13/82-ALC4/2016 Party Name:VIVIMED LABS (,ALATHUR) PRIVATELIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

224

HQ File

:01/82/050/00654/AM17/

RLA File'

:04/24/040/00065/AM17/


09.08.2016

Defer Date:


225

Case No.:17/13/82-ALC4/2016 Party Name:HELLO PAINTS;(P) LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:OI/82/050/00645/AM17/

RLA File

:05/23/040/00220/AMI7/

Lic.No/Date:051039944911.08.2016

Defer Date:

08.11.2017

Decision: Deferred.

|226 lease No.:76/I3/82-ALC4/2016 Party Name:JINDAL DRUGS'Meet No/Date:3/82- Status:

36

PRIVATE LIMITED ALC4/2017

17.05.2017

Deferred

HQ File

;0I/82/050/0D704/AM17/

RLA File

:03/94/040/00391/AM17/


11.08.2016

Defer Date:

08.11.2017

Decision: Deferred.

227

Case No.:18/13/82-ALC4/20I6 Party NameiJUBILANT LIFESCIENCES LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/82/050/00646/AM17/

RLA File

:05/23/040/00230/AM17/


11.08.2016

Defer Date:

08.11.2017

Decision: Deferred.

228

Case No.:61/13/82-ALC4/20I6 Party Name:S M BCORPORATION OF INDIA

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File':0I/82/050/00689/AM17/

RLA File'

:03/95/040/00388/AM17/


11.08.2016

Defer Date:

08.11.2017

Decision: Deferred.

229

Case No.:78/13/82-ALC4/2016 Party NameiAARTLINDUSTRIES LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00706/AM17/

RLA File

:03/94/040/00371/AM17/


12.08.2016

Defer Date:

08.11.2017


230

Case No.:190/17/82-

ALC4/2016

Party Name:GLANDPHARMA LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File;01/82/050/01151/AMI7/

RLA File

:09/24/040/00223/AMI7/


16.08.2016

Defer Date:

08.11.2017


231

Case No.:ll/13/82-ALC4/2016 Party Name:CADILAHEALTHCARE LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

HQ File:01/82/050/00639/AM17/

RLA File

:08/24/040/00190/AM17/


17.08.2016

Defer Date:


232

Case No.:40/13/82-ALC4/20I6 Party Name:AETHERINDUSTRIES LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred


37

;01/82/050/00668/AM17/ :52/24/040/00036/AM17/ 19.08.2016 08.11.2017


i:aseNo.:I9/13/82-ALC4/2016 I1

ârty Name:FRESENIUSCABI ONCOLOGY LIMITED i

Vleet No/Date:3/82- i

\LC4/2017 , 117.05.2017

Status:

deferred

WQ File ]01/82/050/00647/AM17/

Â File05/23/040/00234/AM17/

îc.No/Date:0510399492

19.08.2016

Defer Date:

38.11.2017

[)ecision : Deferred.

Case No.:150/13/82-'

ALC4/2016

Party Name:SUNiPHARMACEUTICAL

INDUSTRIES LTD.,

Vieet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

234 HQ File:01/82/050/00778/AM17/

RLA File:05/24/040/00201/AMI7/


19.08.2016

Defer Date:,

08.11.2017


.

Case No.:152/13/82-

ALC4/2016


INDUSTRIES LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

235

HQ File:01/82/050/00780/AM17/

RLA File':05/24/040/00200/AM17/

Lic.No/Date:0510399505 ■

19.08.2016

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/420/2016-Pi(Norms) dated 11.09.2017, uploaded at the end ofthese minutes or as applied by the firm whichever is iess under para 4.07 of HBP Vol.1.RAconcemed may take necessary action as per decision of NO.

.

Case No.:7/17/82-ALC4/2016 Party Name:AMINES &■PLASTICIZERS LIMITED

Meet No/Date:3/82-iALC4/201717.05.2017

Status:Approved

236

HQ File:01/82/050/00968/AM17/

RLA File:03/94/040/00437/AM17/

Lic.No/Date:031080724422.08.2016

Defer Date:

Decision : The Committee decided to ratify norms based on repeat basis as per earlier decisiontaken by NC in its meeting No.11/82 dated 26.11.2014, upioaded at the end of these minutes oras appiied by the firm whichever is less under para 4.07 of HBP Vol.l.RA concerned may takenecessary action as per decision of NC.

Case No.:69/13/82-ALC4/2016 Party Name:J.B. CHEMICALS& PHARMACEUTICALSLIMITED

Meet No/Date:3/82-ALC4/201717.05.2017

Status:Approved

237

HQ File:01/82/050/00697/AM17/

RLA File:03/94/040/00339/AM17/

Lic.No/Date;031080728922.08.2016

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticais O.M.No. 35011/394/2016-PI(Norms) dated 08.09.2017, upioaded at the end ofthese minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.l.RAconcemed may take necessary action as per decision of NC. _

238Case No.:68/13/82-ALC4/2016 Party Name:J.B. CHEMICALS

& PHARMACEUTICALSMeet No/Date:3/82-ALC4/2017

Status:Approved

38

LIMITED 17.05.2017

HQ File:OI/82/050/00696/AM17/

RLA File

:03/94/040/00453/AMI7/


23.08.2016

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/395/2016-PI(Norms) dated 07.09.2017, uploaded at the end ofthese minutes or as applied by the firm whichever Is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NO.

239

Case No.: 156/13/82-

ALC4/2016

Party NameiMAHIMA LIFESCIENCES PVT.LTD.

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File:01/82/050/00784/AM17/

RLA File

:05/24/040/00214/AM17/


23.08.2016

Defer Date:

08.11.2017

Decision: Deferred.

240

Case No.:141/13/82-

ALC4/2016

Party Name:RHYDBURGPHARMACEUTICALS LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

HQ File:01/82/050/00769/AM17/

RLA File

:05/24/040/00239/AM17/


23.08.2016

Defer Date:


241,

Case No,:94/13/82-ALC4/2016 Party NametBODALCHEMICALS LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00722/AM17/

RLA File

:08/24/040/00I37/AM17/


29.08.2016

Defer Date:

08.11.2017

Decision: Deferred.

242

Case No.: 123/13/82-

ALC4/2016

Party Name:D. R. COATS INK& RESINS PVT. LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00751/AM17/

RLA File

:03/94/040/00265/AM17/


30.08.2016

Defer Date:

08.11.2017

Decision: Deferred.

Case Ng.:81/13/82-ALC4/2016 Party Name:PANACEABIOTEC LTD.,

Meet No/Date;3/82-

ALC4/2017

17.05.2017

Status:

Approved

243

HQ File;Ql/82/050/00709/AM17/

RLA File

:05/24/040/00258/AM17/


30.08.2016

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of DBT O.M.No.BT/IL/05/316/2010-PID dated 05.06.2017, uploaded at the end of these minutes or as appliedby the firm whichever is less under para 4.07 of HBP Vol.1.RA concerned may take necessaryaction as per decision of NC.

39

244

Case No.: 124/13/82-

ALC4/2016

Party Name:ELPPE;CHEMICALS PRIVATE,

LIMITED

Meet No/Date:3/82-'

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00752/AM17/

RLA Filet

:03/94/040/00464/AM17/


01.09.2016

Defer Date:

08.11.2017

Decision: Deferred.

245

Case No.:163/13/82-

ALC4/2016

Party Name;HETERO LABSLIMITED

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File':01/82/050/00791/AM17/

RLA File

:09/24/040/00285/AM17/


01.09.2016

Defer Date:

08.11.2017

Decision: Deferred.

246

Case No.:164/13/82-t

ALC4/2016

Party Name:HETERO LABSjLIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File':01/82/050/00792/AM17/

RLA File

:09/24/040/003II/AM17/


01.09.2016

Defer Date:

08.11.2017

Decision: Deferred.

247

Case No.: 168/13/82-1

ALC4/2016

Party NamerHETERO LABS'LIMITED

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File;01/82/050/00796/AM17/

RLA File

:09/24/040/0030I/AM17/


01.09.2016

Defer Date:

08.11.2017


248

Case No.: 170/13/82-

ALC4/2016

Party NamerHETERO LABSLIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00798/AM17/ '

RLA File,:09/24/040/00284/AM17/

Lic.No/Date:0910064083 '

01.09.2016

Defer Date:,

08.11.2017

Decision: Deferred.

249

Case No.:196/17/82-

ALC4/2D16

Party NamerORCHLABORATORIES INDIA PVT

LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01157/AMI7/

RLA File

:09/24/040/00292/AM17/


01.09.2016

Defer Date:

08.11.2017

Decision: Deferred.

'250

Case No.:95/13/82-ALC4/2016 Party NameiACULIFEHEALTHCARE PRIVATE

LIMITED,

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Approved

HQ File:01/82/050/00723/AM17/

RLA File

:08/24/040/00161/AM17/


02.09.2016

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/o

40

Pharmaceuticals forwarded vide O.M. No. 35011/409/2016-PI(Norms) dated Sept. 2014,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Vol.1 .RA concerned may take necessary action as per decision of NC.

251

Case No.:122/13/82-

ALC4/2016

Party NameiKAIRAVCHEMOFARBE INDUSTRIES

LTD.

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File':01/82/050/00750/AMI7/

RLA File

:03/94/040/00374/AM17/


02.09.2016

Defer Date:

08.11.2017

Decision: Deferred.

252

Case No.: 109/13/82-

ALC4/2016

Party Name:AURAPHARMACEUTICALS PVT.

LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00737/AMI7/

RLA File

:03/94/040/00484/AM17/


06.09.2016

Defer Date:

08.11.2017

Decision: Deferred.

253

Case No.: 197/17/82-

ALC4/2016

Party Name:EYTAN LABSLIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/0n58/AM17/

RLA File

:09/24/040/00252/AM17/


08.09.2016

Defer Date:

08.11.2017


254

Case No.:I67/13/82-

ALC4/2016

Party Name:HETERO LABSLIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00795/AM17/

RLA File

:09/24/040/00300/AM17/


08.09.2016

Defer Date:

08.11.2017

Decision: Deferred.

255

Case No.:169/13/82-

ALC4/2016

Party NameiHETERO LABSLIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00797/AM17/

RLA File'

:09/24/040/00302/AM17/


08.09.2016

Defer Date:

08.11.2017

Decision: Deferred.

256

Case No.:209/17/82-

ALC4/2016

PartyName:INTERNATIONAL

HEALTHCARE LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/0I170/AM17/

RLA File

:09/24/040/00246/AM17/


08.09.2016

Defer Date:

08.11.2017

Decision: Deferred.

257Case No.:108/13/82-

ALC4/2016

Party NamerJ.B. CHEMICALS& PHARMACEUTICALS

Meet No/Date:3/82-

ALC4/2017

Status:

Approved

41

LIMITED 17.05.2017

HQ File!:01/82/050/00736/AM17/ i

RLA File!:03/94/040/00506/AM17/ ;


08.09.2016

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/318/2016-PI(Norms) dated 04.09.2017,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Vol.1.RA concerned may take necessary action as per decision of NO.

258

Case No.:207/17/82-

ALC4/2016

Party Name:MYLAN'LABORATORIES LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01168/AM17/

RLA File

:09/24/040/00310/AM17/


08.09.2016

Defer Date:

08.11.2017

Decision; Deferred.

259

Case No.:137/13/82-i

ALC4/2016

Party Name:NAVINFLUORINE

INTERNATIONAL LIMITED '

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/0D765/AM17/

RLA File'

;03/95/040/00437/AM17/


08.09.2016

Defer Date:'

08.11.2017

Decision: Deferred.

260

Case No.:186/17/82-

ALC4/2016

Party Name:SALICYLATES &,CHEMICALS PRIVATEi

LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File':01/82/050/01147/AM17/ !

RLA Filei

:09/24/040/00231/AM17/


08.09.2016

Defer Date:

08.11.2017

Decision: Deferred.

261

Case No.:199/17/82-

ALC4/2016

Party Name:SALICYLATES &,CHEMICALS PRIVATE^

LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File,:01/82/050/01160/AM17/

RLA File,:09/24/040/0a075/AM17/


08.09.2016

Defer Date:

08.11.2017


262

Case No.:159/13/82-;

ALC4/2016

Party Name:SUN|PHARMACEUTICAL

INDUSTRIES LTD.,

Meet No/Date:3/82-'

ALC4/2017

17.05.2017

Status:

Deferred

HQ File,:01/82/050/00787/AM17/

RLA File

:05/24/040/00264/AM17/


08.09.2016

Defer Date:'

08.11.2017

Decision: Deferred.

263

Case No.:208/17/82-

ALC4/2ai6

Party Name:SUVEN LIFE,SCIENCES LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File,:01/82/050/01169/AM17/

RLA File

:09/24/040/00256/AM17/

Lic.No/Date:0910064101 '

08.09.2016

Defer Date:

08.11.2017

42

Decision: Deferred.

264

Case No.: 166/13/82-

ALC4/2016


Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File;01/82/050/00794/AM17/

RLA File

:09/24/040/00314/AM17/


09.09.2016

Defer Date:

08.II.20I7

Decision: Deferred.

265

Case No.: 165/13/82-

ALC4/2016

Party Name:HONOUR LABLIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00793/AM17/

RLA File

:09/24/040/0032I/AM17/


09.09.2016

Defer Date:

08.11.2017

Decision: Deferred.

266

Case No.:206/17/82-

ALC4/2016

Party Name:AUROBINDOPHARMA LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01167/AM17/

RLA File

:09/24/040/00277/AMI7/


12.09.2016

Defer Date:

08.11.2017

Decision: Deferred.

267

Case No.: 105/13/82-

ALC4/2016

Party NameiAARTI DRUGSLIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00733/AM17/

RLA File

:03/94/040/00487/AMI7/

Lic.No/Date:0310807836 '

16.09.2016

Defer Date:

08.11.2017

Decision: Deferred.

268

Case No.:46/13/82-ALC4/2016 Party NameiGOPINATHCHEM-TECH LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00674/AM17/

RLA File

:08/24/040/00215/AMI7/


16.09.2016

Defer Date:

08.11.2017

Decision: Deferred.

269

Case No.:103/13/82-

ALC4/2016

Party NameiJ.B. CHEMICALS& PHARMACEUTICALS

LIMITED

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File:01/82/050/a0731/AM17/

RLA File

:03/94/040/005I6/AM17/


20.09.2016

Defer Date:

08.11.2017

Decision: Deferred.

270

Case No.:119/13/82-

ALC4/2016

Party Name:GLOBALCALCIUM PRIVATE

LIMITED,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

43

HQ File:01/82/05q/00747/AM17/

RLA File'

:07/24/040/00207/AM17/ ;Lic.No/Date:0710110442

21.09.2016

Defer Date:

08.11.2017 '

Decision: Deferred.

271

Case No.:45/13/82-ALC4/2016 Party Name:BIO TECHOPHTHALMICS PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

HQ File:01/82/050/00673/AM17/

RLA Filei:08/24/040/00216/AM17/


22.09.2016

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/353/2016-Pi{Norms) dated 06.09.2017,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Vol.1.RA concerned may take necessary action as per decision of NO.

272

Case No.:91/13/82-ALC4/2016 Party NameiCADILA,HEALTHCARE LTD i

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00719/AMI7/

RLA File,

:08/24/040/00242/AM17/


22.09.2016

Defer Date:'

08.11.2017

Decision: Deferred.

273

Case No.:100/13/82-

ALC4/2016

Party NameiK V AROCHEM'PVT. LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00728/AM17/

RLA Filel

:03/94/040/00525/AM17/


22.09.2016

Defer Date:

08.11.2017


274

Case No.:I92/17/82-

ALC4/2016

Party NameiSATYADEEPTHA

PHARMACEUTICALS LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01153/AM17/

RLA File

:09/24/040/00332/AM17/


22.09.2016

Defer Date:,08.11.2017 '

Decision: Deferred.

275

Case No.:82/13/82-ALC4/2016.Party Name:VERTELLUSSPECIALTY MATERIALS!

(INDIA) PVT.LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:0I/82/050/00710/AM17/

RLA File^

:52/24/040/00040/AM17/


22.09.2016

Defer Date:

08.11.2017

Decision: Deferred.

276

Case No.;56/17/82-ALC4/2016;Party Name:J.B. CHEMICALS!& PHARMACEUTICALS!

LIMITED

Meet No/Date:3/82-i

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01017/AM17/

RLA File

:03/94/040/00582/AM17/


26.09.2016

Defer Date:

08.11.2017

Decision: Deferred.

44

2ir

Case No.:102/17/82-

ALC4/2016

Party Name:PAB ORGANICSPVT.LTD,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01063/AM17/

RLA File

:34/24/040/00180/AM17/


26.09.2016

Defer Date:

08.11.2017

Decision: Deferred.

278

Case No.: 193/17/82-'

ALC4/2016

Party NameiPORUSLABORATORIES PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/DI154/AM17/

RLA File

:09/24/040/00345/AMI7/


26.09.2016

Defer Date:

08.11.2017

Decision: Deferred.

279

Case No.:195/17/82-

ALC4/2016

Party Name:PORUSLABORATORIES PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01156/AM17/

RLA File

:09/24/040/00344/AM17/


26.09.2016

Defer Date:

08.11.2017

Decision: Deferred.

280


Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01016/AM17/

RLA File

:03/94/040/00570/AM17/


27.09.2016

Defer Date:

08.11.2017


281

Case No.:13/17/82-ALC4/2016 Party Name:GUJARATORGANICS LIMITED

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File:01/82/050/00974/AM17/

RLA File

:03/94/040/00585/AM17/


27.09.2016

Defer Date:.

08.11.2017

Decision: Deferred.

282

Case No.:113/13/82-

ALC4/2016


Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File:01/82/050/00741/AM17/

RLA File

:09/24/040/0a342/AM17/


27.09.2016

Defer Date:

08.11.2017


283

Case No.: 114/13/82-

ALC4/2016

Party NamerHETERO LABSLIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00742/AM17/

RLA File

:09/24/040/00341/AM17/


27.09.2016

Defer Date:

08.11.2017

45

Decision: Deferred.

ooN(

Case No.:54/17/82-ALC4/2016 Party Name:K V AROCHEMPVT. LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File.:0I/82/050/01015/AM17/

RLA File

:03/94/040/00524/AM17/

Lic.No/Date:0310808098 .

27.09.2016

Defer Date:

08.11.2017

Decision: Deferred.

285

Case No.:139/13/82-

ALC4/2016

Party Name:VISWAATCHEMICALS LIMITED

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File::01/82/050/00767/AM17/

RLA File

:03/95/040/00302/AMI7/

Lic.No/Date:0310808110 ,

27.09.2016.

Defer Date:

08.11.2017 '

Decision: Deferred.

286

Case No.:194/17/82-

ALC4/2016

Party Name:SUVEN LIFE,SCIENCES LIMITED

Meet No/Date: 3/82-.

ALC4/2017

17.05.2017

Status:

Deferred

HQ File':01/82/050/01155/AM17/

RLA File

:09/24/040/00339/AM17/


29.09.2016

Defer Date:,

08.11.2017

Decision: Deferred.

287

Case No.:12/17/82-ALC4/2016 Party NamerALIVIRAANIMAL HEALTH LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00973/AM17/

RLA File,

:03/94/a40/00557/AM17/


30.09.2016

Defer Date:'

08.11.2017

Decision: Deferred.

288

Case No.:90/13/82-ALC4/2016 Party Name:AMI ORGANICSPVT LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File':01/82/050/00718/AM17/

RLA File;

:52/24/040/00042/AM17/ i

Lic.No/Date:5210042032 ;30.09.2016

Defer Date:

08.11.2017


289

Case No.:125/13/82-

ALC4/2016

Party Name:SURVIVALTECHNOLOGIES PVT.LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File.:ai/82/050/00753/AM17/

RLA File'

:03/95/040/00490/AM17/ :Lic.No/Date:0310808208 :

30.09.2016



290

Case No.:126/13/82-,

ALC4/20I6

Party Name:SURVIVAL,TECHNOLOGIES PVT.LTD. |

Meet No/Date:3/82-,

ALC4/2017 ;17.05.2017

Status:

Deferred

46

HQ File:01/82/050/00754/AM17/

RLA File

:03/95/040/00410/AM17/


30.09.2016

Defer Date:

08.11.2017

Decision: Deferred.

291

Case No.:129/l/82-ALC4/2017 Party Name:GRANULESINDIA LIMITED

Meet No/Date:3/82-'ALC4/2017

17.05.2017

Status:

Approved

HQ File,:01/82/050/01483/AM17/

RLA File

:09/24/040/00365/AM17/

Lic.No/Date;0910064234 ;

05.10.2016

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/270/2016-PI(Norms) dated Oct. 2016, uploadedat the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBPVoi.l.RA concerned may take necessary action as per decision of NO.

292

Case No.:182/17/82-

ALC4/2016

Party Name:MYLANLABORATORIES LIMITED

Meet No/Date:3/82-,

ALC4/2017

17.05.2017

Status:

Deferred

HQ File':01/82/050/01143/AM17/

RLA File

:09/24/040/00305/AM17/


05.10.2016

Defer Date:

08.11.2017

Decision: Deferred.

293

Case No.:204/17/82-

ALC4/2016

Party Name:NAGARJUNAAGRICHEM LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01165/AM17/

RLA File

:09/24/040/00313/AM17/


05.10.2016

Defer Date:

08.11.2017

Decision: Deferred.

294

Case No.:29/17/82-ALC4/2016 Party Name:PALADINPAINTS AND CHEMICALS

PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00990/AM17/

RLA File

:03/95/040/00514/AM17/


05.10.2016

Defer Date:

08.11.2017


295

Case No.:200/17/82-

ALC4/2016

Party Name:AUROBINDO'PHARMA LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01161/AM17/

RLA File

:09/24/040/00312/AM17/


06.10.2016

Defer Date:

08.11.2017


296

Case No.:ll/17/82-ALC4/2016 Party Name:CIPLA LIMITED. Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00972/AMI7/

RLA File

:03/94/040/00617/AM17/


06.10.2016

Defer Date:

08.11.2017

Decision: Deferred.

47

297

Case No.:75/17/82-ALC4/2016 Party NameiMAHAVIRSYNTHESIS PRIVATE

LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/^2/050/01036/AM17/RLA File

:52/24/040/00043/AM17/Lic.No/Date:521004203806.10.2016

Defer Date:

08.11.2017


Case No.:205/17/82-

ALC4/2016

Party Name:SATYADEEPTHA

PHARMACEUTICALS LTD

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Approved

298

HQ File

:01/82/050/01166/AM17/RLA File

:09/24/040/00375/AM17/Lic.No/Date:091006423506.10.2016

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/o,Pharmaceuticals forwarded vide O.M. No. 35011/135/2016-PI(Norms) dated July 2016, uploaded^at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBPVol.1 .RA concerned may take necessary action as per decision of NO.

299

Case No.:33/17/82-ALC4/2ai6'Party NameiYASHOiINDUSTRIES PVT.LTD.

Meet No/Date:3/82-,

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/82/050/Oa994/AM17/

RLA File

:03/95/040/00546/AM17/Lic.No/Date:031080837613.10.2016

Defer Date:

08.11.2017

Decision: Deferred.

300

Case No.:69/17/82-ALC4/2016 Party Nanie:PORUSLABORATORIES PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/82/050/01030/AMI7/RLA File

:09/24/040/00374/AM17/Lic.No/Date:091006426514.10.2016

Defer Date:

08.11.2017


301

Case No.:201/17/82-

ALC4/2016

Party Name:PORUS|LABORATORIES PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File'

:01/82/050/01162/AM17/RLA File'

:09/24/040/00354/AM17/Lic.No/Date;0910064264 '14.10.2016

Defer Date:

08.11.2017

Decision: Deferred.

302

Case No.:49/17/82-ALC4/2016,Party Name:CIPLA LIMITED. Meet No/Date:3/82-i

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/OI010/AM17/

RLA File

03/94/040/00622/AM17/Lic.No/Date:031080843317.10.2016

Defer Date:

08.11.2017

Decision: Deferred.

.

303Case No.:9/17/82-ALC4/20I6 Party Name:CLARIANT

INDIA LIMITEDMeet No/Date:3/82-

ALC4/2017

Status:

Deferred

48

17.05.2017

HQ File:01/82/050/00970/AM17/

RLA File

:03/94/040/00629/AM17/


17.10.2016

Defer Date:

08.11.2017

Decision: Deferred.

304

Case No.:39/17/82-ALC4/2016 Party Name:PRIVI ORGANICSLTD

Meet No/Date:3/82-;

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01000/AM17/

RLA File

:03/95/040/00324/AM17/

Lic.No/Date:0310808410 ,

17.10.2016

Defer Date:

08.11.2017

Decision: Deferred.

305

Case No.:31/17/82-ALC4/2016 Party Name:REANNONPHARMACEUTICALS

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00992/AM17/

RLA File

:03/95/040/00540/AM17/


17.10.2016

Defer Date:

08.11.2017


306

Case No.:25/I7/82-ALC4/2016 Party Name:CLARIANTINDIA LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00986/AM17/

RLA File

:03/94/040/00648/AM17/


18.10.2016

Defer Date:

08.11.2017

Decision: Deferred.

307

Case No.:214/17/82-

ALC4/2016

Party NameiDEEPAKNOVOCHBM

TECHNOLOGIES LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01175/AM17/

RLA File

:31/83/040/00071/AM17/


20.10.2016

Defer Date:

08.11.2017

Decision: Deferred.

308

Case No.:76/17/82-ALC4/2016 Party Name:GOLD STARINTERNATIONAL

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01037/AM17/

RLA File

:52/24/040/00046/AMI7/


25.10.2016

Defer Date:

08.11.2017


309

Case No.:94/17/82-ALC4/20I6 Party Name:SHlVAPHARMACHEM LTD

Meet No/Date:3/82-

ALC4/20i7

17.05.2017

Status:

Deferred

HQ File;01/82/050/01055/AM17/

RLA File

:34/24/040/00204/AM17/


25.10.2016

Defer Date:

08.11.2017

Decision: Deferred.

49

310

Case No.:15/17/82-ALC4/2016 Party Name:HARMONYLIFESCIENCE PRIVATELIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/82/050/00976/AM17/RLA File

;03/94/040/00672/AM17/Lic.No/Date:0310808773

26.10.2016

Defer Date:

08.11.2017

Decision: Deferred.

311

Case No.:20/I7/82-ALC4/2016 Party Name:BLUE CIRCLEORGANICS PVT. LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/82/050/00981/AM17/RLA File

:03/94/040/00606/AM17/Lic.No/Date:0310808832

27.10.2016

Defer Date:

08.11.2017


312

Case No.;21/17/82-ALC4/2016 Party NameiBLUE CIRCLEORGANICS PVT. LTD.

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File

;01/82/050/aD982/AM17/RLA File

:03/94/040/00548/AMI7/Lic.No/Date:031080883027.10.2016

Defer Date:

08.11.2017


313

Case No.:95/17/82-ALC4/2016'Party Name:CONCORD'BIOTECH LTD

Meet No/Date:3/82-'

ALC4/2017

17.05.2017

Status;

Deferred

HQ File

:01/82/050/01056/AM17/RLA File

:08/24/040/00268/AM17/Lic.No/Date:081013899728.10.2016

Defer Date:

08.11.2017


Case No.:18/17/82-ALC4/2016 Party Name;J.B. CHEMICALS^& PHARMACEUTICALS.LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

314

HQ File:01/82/050/00979/AM17/

RLA File.

:03/94/040/00718/AM17/Lic.No/Date:0310809038

08.11.2016Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/343/2016-Pl(Norms) dated 24.08.2017,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Vol.1.RA concerned may take necessary action as per decision of NO.

•

Case No.:43/17/82-ALC4/2016i Party NamerJ.B. CHEMICALS'& PHARMACEUTICALS'

LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

'315

HQ File

01/82/050/01004/AM17/RLA File

03/94/040/00703/AM17/Lic.No/Date:031080903908.11,2016

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/343/2016-PI(Norms) dated 24.08.2017.uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07'Df HBP Vol.l.RA concerned may take necessary action as per decision of NC.

|316 |Case No.:22/17/82-ALC4/20I6 Party Name:J.B. CHEMICALS Vleet No/Date:3/82- iStatus:

50

& PHARMACEUTICALS

LIMITED

ALC4/2017

17.05.2017

Approved

HQ File:01/82/050/a0983/AM17/

RLA File

:03/94/040/00726/AM17/


09.11.2016

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals fonwarded vide O.M. No. 35011/343/2016-Pi(Norms) dated 24.08.2017,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP VoI.I.RA concerned may take necessary action as per decision of NO.

317

Case No.:88/17/82-ALC4/2016 Party Name:SHIVAPHARMACHEM LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01049/AM17/

RLA File

:34/24/040/00220/AM17/


09.11.2016

Defer Date:

08.11.2017

Decision: Deferred.

318

Case No.:26/17/82-ALC4/2016 Party Name:STERLlNGAUXILIARIES PVT LTD

Meet No/Date;3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00987/AM17/

RLA File

:03/95/040/00348/AM17/


09.11.2016

Defer Date:'

08.11.2017


319

Case No.:37/17/82-ALC4/2016 Party NameiSTERLlNGAUXILIARIES PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00998/AM17/

RLA File

:03/95/040/00344/AM17/


09.11.2016

Defer Date:

08.11.2017


320

Case No.:l7/I7/82-ALC4/2016 Party NameT.B. CHEMICALS& PHARMACEUTICALS

LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

HQ File:01/82/050/00978/AM17/

RLA File

:03/94/040/00730/AM17/


10.11.2016

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/343/2016-PI(Norms) dated 24.08.2017,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Voi.lRA concerned may take necessary action as per decision of NC.

321

Case No.:45/17/82-ALC4/2016 Party NameiKRISHNAANTIOXIDANTS PVT. LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01006/AM17/

RLA File

:03/94/040/00704/AM 17/


10.11.2016

Defer Date:

08.11.2017

Decision: Deferred.

322Case No.:2/I5/82-ALC4/20I6 Party Name:STERLING

AUXILIARIES PVT LTD

Meet No/Date:3/82-

ALC4/2017

Status:

Deferred

51

17.05.2017

HQ File01/82/050/00816/AM17/

RLA File03/95/040/00449/AMI7/

Lic.No/Date:0310809088 '10.11.2016

Defer Date:

38.11.2017

Decision: Deferred.

Case No.:41/17/82-ALC4/2016, ^arty Name:STERLING'AUXILIARIES PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

323 HQ File,:01/82/050/01002/AM17/

RLA File':03/95/040/00515/AM17/

Lic.No/Date:0310809091 ,10.11.2016

Defer Date:

08.11.2017

Decision: Deferred.

Case No.:103/17/82-;ALC4/2016

Party Nanie:FRESENIUSiKABI ONCOLOGY LIMITED

Meet No/Date:3/82-.

ALC4/2017

17.05.2017

Status:

Deferred

324 HQ File:01/82/050/01064/AM17/

RLA File':05/23/040/00370/AM17/


11.11.2016

Defer Date:

08.11.2017 '


CaseNo.:92/l/82-ALC4/2017 , Party Name:HARMONYlLIFESCIENCE PRIVATEjLIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

S2t> HQ File,:01/82/050/01446/AM17/

RLA File:03/94/040/00701/AM17/


11.11.2016

Defer Date:

08.11.2017


Case No.:19/17/82-ALC4/2016!Party Name:HIKAL LIMITED Meet No/Date:3/82-'

ALC4/20I7

17.05.2017

Status:

Deferred

326 HQ File:01/82/050/00980/AM17/

RLA File;03/94/040/00687/AM17/

Lic.No/Date:0310809149 '

11.11.2016

Defer Date:

08.11.2017


Case No.:101/17/82-

ALC4/2016

Party Name:JUBILANTGENEEUCS LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

327 HQ File:01/82/050/01062/AM17/

RLA File:05/23/040/00372/AMI7/


11.11.2016

Defer Date:

08.11.2017 ■

Decision: Deferred.

'328

Case No.:130/17/82-

ALC4/2016

Party Name:BAYER VAPIPVT.LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01091/AM17/

RLA File

:03/94/040/00735/AMI7/


22.11.2016

Defer Date:'

08.11.2017


52

329

Case No.:138/17/82-

ALC4/2016

Party Name:MAPLE CROSSREMEDIES PRIVATE

LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File;01/82/050/0I099/AM17/

RLA File,

:03/95/040/00624/AM17/


22.11.2016

Defer Date:

08.11.2017

Decision: Deferred.

330

Case No.:66/17/82-ALC4/2016 Party Name:MEGHMANIINDUSTRIES LTD,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01Q27/AM17/

RLA File

:08/24/040/00293/AM17/


22.11.2016

Defer Date:

08.11.2017

Decision: Deferred.

331

Case No.: 118/1/82-ALC4/2017 Party Name:RELIANCEINDUSTRIES LTD.

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File:01/82/050/01472/AM17/

RLA File

:03/95/040/00542/AM17/


22.11.2016

Defer Date:

08.11.2017

Decision: Deferred.

332

Case No.:91/17/82-ALC4/2016 Party Name:RONAKCHEMICALS

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01052/AM17/

RLA File

:34/24/040/0D224/AM17/


22.11.2016

Defer Date:

08.11.2017

Decision: Deferred.

333

Case No.:124/17/82-

ALC4/2016

Party Name:SURVIVALTECHNOLOGIES PVT.LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01085/AM17/

RLA File

:03/95/040/0a639/AM17/


22.11.2016

Defer Date:

08.11.2017


334

Case No.: 120/17/82-

ALC4/2016

Party Name:ZIMLABORATORIES LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01081/AM17/

RLA File

:03/95/040/006a2/AM17/


22.11.2016

Defer Date:

08.11.2017


335

Case No.:141/17/82-

ALC4/2016

Party Name:MELOGSPECIALITY CHEMICALS

PVT. LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01102/AM17/

RLA File

:03/95/040/00610/AM17/


23.11.2016

Defer Date:

08.11.2017


53

Case No.:98/17/82-ALC4/2016;'

'arty Name:NECTARLIFESCIENCES LIMITED, ,

^eet No/Date;3/82-

ALC4/2017 '17.05.2017

Status:

Deferred

336 HQ File01/82/050/D1059/AM17/

RLA File22/24/040/0007I/AM17/


23.11.2016

Defer Date:

08.11.2017


337

Case No.:99/17/82-ALC4/2016 Party Name:SAURAV'CHEMICALS LTD,

Meet No/Date:3/82-i

ALC4/2017

17.05.2017

Status:

Deferred

HQ File;01/82/050/01060/AM17/

RLA File

:22/24/O40/0a073/AM17/


23.11.2016

Defer Date:

08.11.2017

Decision: Deferred.

,338

Case No.:l/17/82-ALC4/2016 Party Naine:YASHOINDUSTRIES PVT.LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/00962/AM17/

RLA File'

:03/95/040/00640/AM17/


23.11.2016

Defer Date:

08.11.2017

Decision: Deferred.

■339

Case No.:87/17/82-ALC4/2016 Party Name:ASIATIC DRUGSi&PHARMACEUTICALS PVT.LTD.

Meet No/Date:3/82-ALC4/201717.05.2017

Status:Deferred

HQ File:01/82/050/01048/AM17/

RLA File:05/23/040/00365/AM17/

Lic.No/Date:051040045324.11.2016


Decision: Deferred.

340

Case No.:86/17/82-ALC4/2016. Party Naine:ALCHEMINTERNATIONAL PVT. LTD.

Meet No/Date:3/82-iALC4/201717.05.2017

Status:Deferred

HQ File:01/82/050/01047/AM17/

RLA File:05/23/040/a0358/AM17/

Lic.No/Date:051040047425.11.2016


Decision: Deferred.

341

Case No.:155/17/82-ALC4/2016

Party NameiCIPLA LIMITED. Meet No/Date:3/82-ALC4/201717.05.2017

Status:Deferred

HQ File:01/82/050/01116/AM17/

RLA File:03/94/040/00757/AM17/

Lic.No/Date:031080932325.11.2016


Decision: Deferred.

342

Case No.:179/17/82-ALC4/2016

Party Name:BLUE CIRCLEORGANICS PVT. LTD.

Meet No/Date:3/82-ALC4/201717.05.2017

Status:Deferred

HQ File:01/82/050/01140/AM17/

RLA File:03/94/040/00744/AM17/

Lic.No/Date:031080937328.11.2016


54

Decision: Deferred.

343

Case No.:89/17/82-ALC4/2016 Party Name:CADILAi

PHARMACEUTICALS LTD.

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Approved

HQ File:01/82/050/01050/AM17/

RLA File

;08/24/040/00319/AM17/


28.11.2016

Defer Date:

Decision :The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/132/2017-PI(Norms) dated 13.04.2017,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Voi.1 .RA concerned may take necessary action as per decision of NO.

344

Case No.: 129/17/82-

ALC4/2016

Party Name:DELTAFINOCHEM PVT.LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ Filei;01/82/050/01090/AM17/

RLA File

:03/94/040/00675/AM17/


28.11.2016

Defer Date:

08.11.2017

Decision: Deferred.

345

Case No.:180/17/82-

ALC4/2016

Party Name:ENCUBEETHICALS PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/0114I/AM17/

RLA File

:03/94/040/00689/AM17/


28.11.2016

Defer Date:

08.11.2017

Decision: Deferred.

346

Case No.:84/17/82-ALC4/2016 Party NameiMOREPENLABORATORIES LTD.,

Meet No/Date:3/82-,ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/82/050/01045/AM17/

RLA File

:05/24/040/00415/AM17/


28.11.2016

Defer Date:

08.11.2017


347

Case No.:163/17/82-

ALC4/2016

Party Name:AVA

CHEMICALS PVT.LTD.,Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/OI124/AM17/

RLA File

:03/94/040/00734/AM17/


29.11.2016

Defer Date:

08.11.2017

Decision: Deferred.

348

Case No.:164/17/82-

ALC4/2016

Party NameiAVA

CHEMICALS PVT.LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01125/AM17/

RLA File

:03/94/040/00733/AM17/


29.11.2016

Defer Date:

08.11.2017


|349 Case No.:165/17/82- Party Name:AVA Meet No/Date:3/82- Status:

55

1 \LC4/2016 CHEMICALS PVT.LTD., ALC4/2017

17.05.2017

)eferred

HQ File,.01/82/050/01126/AM17/

RLA File,03/94/040/00731/AM17/


29.11.2016

Defer Date:,

08.11.2017

necision: Deferred.

350!

Case No.:118/17/82-ALC4/20I6

Party NameiSUPREET'CHEMICALS PVT.LTD.


17.05.2017

Status:

Deferred

HQ File:01/82/050/01079/AM17/

RLA File';52/24/040/00050/AM17/

Lic.No/Date:5210042073 '

29.11.2016

Defer Date:

08.11.2017


351

Case No.:139/17/82-ALC4/2016

Party Name:ZIMLABORATORIES LTD.


17.05.2017

Status:

Approved

HQ File:01/82/050/01100/AM17/

RLA File:03/95/040/00684/AM17/

Lic.No/Date:031080940629.11.2016

Defer Date:

Ph™u«cals vTde" 0.m: Na' 35011/404/2012.P,(Norms, dated 12.097017uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.0of HBP Vol.1.RA concerned may take necessary action as per decision of NO.

1

::ase No.:151/I7/82-;I\LC4/2016 '

^arty Natne:STERLING!\UXIL1AR1ES PVT LTD ■ i

Vieet No/Date;3/82- i\LC4/2017 1

17.05.2017

Status:

Deferred

352 HQ File01/82/050/01112/AM17/

RLA File03/95/040/00676/AM17/


30.11.2016

Defer Date:

08.11.2017

Decision: Deferred.

Case No.:85/I7/82-ALC4/20I6,Party Name:SENTISSPHARMA PVT.LTD.


17.05.2017

Status:

Approved ,

353

HQ File:01/82/050/01046/AM17/

RLA File-.05/24/040/00416/AM17/ |

Lic.No/Date:051040057001.12.2016

Defer Date;

Decision : The Committee decided to ratify norms based on the recommendation ot u/oPharmaceuticais forwarded vide O.M. No. 35011/41/2016-Pi(Norms dated18.11.2016 uploadedat the end of these minutes or as applied by the firm whichever is tess under para 4.07 of HBPVol 1 RA concerned may take necessary action as per decision of NO.

Case No.: 116/17/82-ALC4/2016

Party Name:AETHERINDUSTRIES LIMITED


17.05.2017

Status:

Deferred

'354 HQ File:01/82/050/01077/AM17/ .

RLA File:52/24/040/00053/AM17/


02.12.2016

Defer Date:

08.11.2017

Decision ; Deferred. -

[355 Case No.:133/17/82-ALC4/2016

Party Naine:AMlNES &PLASTICIZERS LIMITED


Status:

, Approved

56

17.05.2017

HQ File:01/82/050/01094/AM17/

RLA File

:03/94/040/00771/AM17/


02.12.2016

Defer Date;

Decision : The Committee decided to ratify norms based on repeat basis as per earlier decisiontaken by NO In its meeting No.19/82 dated02.01.2014, uploaded at the end of these minutes oras applied by the firm whichever is less under para 4.07 of HBP Vol.1.RA concerned may takenecessary action as per decision of NO.

Case No.:132/17/82-

ALC4/2016

Party Name;J.B. CHEMICALS& PHARMACEUTICALS

LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

356

HQ File:01/82/050/01093/AM17/

RLA File

:03/94/040/00775/AM17/


02.12.2016

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/516/2015-PI(Norms) dated30.08.2016,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Vol.1 .RA concerned may take necessary action as per decision of NC.

357

Case No.:128/l/82-ALC4/2017 Party NamerSTRIDES.SHASUN LIMITED

Meet No/Date:3/82-'

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01482/AM17/

RLA File

104/24/040/00145/AM17/


02.12.2016

Defer Date:

08.11.2017

Decision: Deferred.

358

Case No.:97/17/82-ALC4/2016 Party Name:CADlLAHEALTHCARE LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

HQ File:01/82/050/01058/AMI7/

RLA File

:08/24/040/00324/AM 17/


05.12.2016

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/570/2013-PI(Norms) dated 24.12.2013,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Vol.1.RA concerned may take necessary action as per decision of NC.

359

Case Nq.:181/17/82-

ALC4/2016

Party Nanie:CENTAURPHARMACEUTICALS PVT.

LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

HQ File:01/82/050/01I42/AM17/

RLA File

:03/94/040/00537/AM17/

Lic.No/Date:03i 0809606

05.12.2016

Defer Date:

Decision ; The Committee decided to ratify norms on pro-rata basis based on therecommendation of D/o Pharmaceuticals O.M. No. 35011/347/2016-PI(Norms) dated 03.04.2017,uploaded at the end of these minutes or as applied by the firm whichever Is less under para 4.07of HBP Vol.1.RA concerned may take necessary action as per decision of NC.

360

Case No.:131/17/82-

ALC4/2016

Party NameiELPPECHEMICALS PRIVATE

LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01092/AM17/

RLA File

:03/94/040/00794/AM 17/


05.12.2016

Defer Date:

08.11.2017

57

Decision: Deferred.

Case No.: 128/17/82-

ALC4/2016

*arty Name:GLENMARKPHARMACEUTICALS LTD., ;

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

361 HQ File'01/82/050/01089/AM17/

RLA Filej03/94/040/00801/AM17/

Lic.No/Date:0310809609 ,05.12.2016

Defer Date:

08.11.2017 '

Decision: Deferred.

Case No.:82/17/82-ALC4/2016, Party NameiGOPINATH,CHEM-TECH LTD.,

Meet No/Date:3/82-'

ALC4/2017

17.05.2017

Status:

Deferred

362 HQ File,:OI/82/050/01043/AM17/

RLA File

:08/24/040/00318/AM17/


05.12.2016

Defer Date;,

08.11.2017

Decision: Deferred.

Case No.:31/l/82-ALC4/2017 Party Name:RONAK|CHEMICALS

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

363 HQ File:01/82/050/01385/AM17/

RLA File:34/24/040/00225/AM17/


05.12.2016

Defer Date:

08.11.2017

Decision: Deferred.

364

Case No.:96/17/82-ALC4/2016 Party Name:CADILAHEALTHCARE LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01057/AM17/

RLA Filei:08/24/040/00326/AM17/ _ '


06.12.2016

Defer Date:

08.11.2017

Decision: Deferred.

;365

Case No.:78/17/82-ALC4/2016;1

Party Name;INDIA GLYCOLS,LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred '

HQ File:01/82/050/01039/AM17/

RLA File

:05/23/040/00412/AM17/


06.12.2016

Defer Date:

08.11.2017

Decision: Deferred.

366

Case No.:135/17/82-

ALC4/2016

Party Name:YASHOINDUSTRIES PVT.LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status: '

Deferred

HQ File:01/82/050/01096/AM17/

RLA File

:03/95/040/00697/AM17/


06.12.2016

Defer Date:,

08.11.2017


!367

Case No.:79/17/82-ALC4/2016 Party Name:ABEERSPHARMACEUTICALS PVT

LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

58

HQ File01/82/050/01040/AM17/

RLA File

05/23/040/00426/AM17/


07.12.2016

Defer Date:

08.11.2017


368

Case No.:80/17/82-ALC4/2016 Party NameiABEERSPHARMACEUTICALS PVT'

LTD

VIeet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File:01/82/050/01041/AM17/

RLA File

:05/23/040/00424/AM17/

Lic.No/Date:051040065 8 '

07.12.2016

Defer Date:,

08.11.2017


369

Case No.:83/17/82-ALC4/2016 Party NameilNDO PHYTOCHEMICALS PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01044/AM17/

RLA File

:05/23/040/00361/AM17/


07.12.2016

Defer Date:

08.11.2017


370

Case No.:126/17/82-

ALC4/2016

Party Name:AMINES &PLASTICIZERS LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01087/AM17/

RLA File

:03/94/040/00803/AM17/


08.12.2016

Defer Date:

08.11.2017

Decision: Deferred.

371

Case No.:127/I7/82-

ALC4/2016

Party Name:KAIRAVCHEMOFARBE INDUSTRIES

LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01088/AM17/

RLA File

:03/94/040/00800/AM17/


08.12.2016

Defer Date:

08.11.2017

Decision: Deferred.

372

Case No.:81/17/82-ALC4/2016 Party NameiBIO TECHOPHTHALMICS PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01042/AM17/

RLA File

:08/24/040/00360/AM17/


09.12.2016

Defer Date:

08.11.2017

Decision: Deferred.

373

Case No.:36/l/82-ALC4/2017 Party NameiENVEE DRUGSPVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

HQ File:01/82/050/01390/AM17/

RLA File

:34/24/040/00232/AM17/


09.12.2016

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/123/2012-PI(Norms) dated July 2016, uploadedat the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBPVol.1 .RA concerned may take necessary action as per decision of NO.

59

Case No.:37/l/82-ALC4/2017 Party Name:ENVEE DRUGSPVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

374

HQ File:01/82/050/01391/AM17/

RLA File

:34/24/040/00239/AM17/


09.12.2016

Defer Date:

1

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.WI. No. 35011/123/2D12-Pi(Norms) dated July 2016, uploadedat the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBPVoI.I.RA concerned may take necessary action as per decision of NO.

375

Case No.:29/l/82-ALC4/2017 Party Name:GULBRANDSENCHEMICALS PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File'

;01/82/050/01383/AM17/

RLA File'

:34/24/040/0Q247/AM17/


09.12.2016

Defer Date:

08.11.2017

' Decision : Deferred.

376

Case No.:187/17/82-

ALC4/2016

Party Name:SRINIPHARMACEUTICALS

PRIVATE LIMITED

Meet No/Date:3/82-i

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/82/050/01148/AM17/

RLA File'

:09/24/040/00483/AM17/Lic.No/Date:09I0064463

09.12.2016

Defer Date:

08.11.2017

' Decision : Deferred.

377

Case No.:148/17/82-

ALC4/2016

Party NameiSTERLING,AUXILIARIES PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/82/050/01109/AM17/RLA File

:03/95/040/00703/AM17/Lic.No/Date:0310809708

09.12.2016

Defer Date:

08.11.2017

Decision: Deferred.

.

378

Case No.:158/17/82-

ALC4/2016

Party Name:STERLING,AUXILIARIES PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017 ■

Status:

Deferred

HQ File

:01/82/050/01119/AM17/RLA File

:03/95/040/00690/AM17/Lic.No/Date:031080972709.12.2016

Defer Date:

08.11.2017

Decision: Deferred.

Case No.:159/17/82-

ALC4/2016

Party Name;UNIMAXLABORATORIES PVT.LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

379

HQ File'

:01/82/050/01120/AM]7/RLA File'

:03/95/040/00669/AM17/Lic.No/Date:0310809709


Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/119/2012-PI(Norms) dated July 2016. uploaded'at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBPVoI.I.RA concerned may take necessary action as per decision of NC.

60

380

Case No.: 107/17/82-

ALC4/2016

Party Name:AMANTAHEALTHCARE LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01068/AM17/

RLA File

:08/24/040/00361/AM17/


13.12.2016

Defer Date:

08.11.2017


381

Case No.: 178/17/82-

ALC4/2016

Party Name:AMINES &PLASTICIZBRS LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01139/AM17/

RLA File

:03/94/040/00804/AM17/


13.12.2016

Defer Date:

08.11.2017

Decision: Deferred.

382

Case No.:146/17/82-

ALC4/2016

Party Name:CIPLA LIMITED. Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01107/AM17/

RLA File

:03/94/040/00835/AM17/


13.12.2016

Defer Date:

08.11.2017

Decision: Deferred.

383

Case No.:173/17/82-

ALC4/2016

Party Name:HARMONYLIFESCIENCE PRIVATE

LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01I34/AM17/

RLA File

:03/94/040/00815/AM17/


13.12.2016

Defer Date:

08.11.2017


384

Case No.:19/I/82-ALC4/2017 Party Name:IND-SWIFTLABORATORIES LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01373/AM17/

RLA File

:22/24/040/00081/AM17/

Lic.No/Date:2210015609 '

13.12.2016

Defer Date:

08.11.2017

Decision: Deferred.

385

Case No.: 142/17/82-

ALC4/2016

Party Name:JINDAL DRUGSPRIVATE LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01103/AM17/

RLA File

:03/94/040/00818/AM17/


13.12.2016

Defer Date:

08.11.2017

Decision: Deferred.

386

Case No.: 143/17/82-

ALC4/2016

Party Name:JINDAL DRUGSPRIVATE LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01104/AM17/

RLA File

:03/94/040/00819/AM17/


13.12.2016

Defer Date:

08.11.2017


61

Case No.:160/17/82-

\LC4/2016

*arty Name:SIRMAXOjCHEMICALS PVT LTD

Meet No/Date:3/82-:

\LC4/2017

17.05.2017

Status:

)eferred •

387 HQ File01/82/050/01121/AM17/

RLA File

03/95/040/00492/AM17/


13.12.2016

Defer Date:

08.I1.2O17

Decision: Deferred.

CaseNo.:35/l/82-ALC4/2017 , i^arty Name:ALEMBIC'PHARMACEUTICALS LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

388 HQ File..01/82/050/01389/AM17/

RLA File:34/24/040/00248/AM17/


14.12.2016

Defer Date:

08.11.2017

Decision: Deferred.

Case No.:153/17/82-,

ALC4/2016

Party Name:PALADINPAINTS AND CHEMICALS

PVT LTD

Meet Nb/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

389 HQ File'-.01/82/050/01114/AM17/

RLA File'

:03/95/040/00699/AM17/


14.12.2016

Defer Date:

08.11.2017

Decision: Deferred.

)

Case No.: 147/17/82-

ALC4/2016

Party Name:S M CHEMICALVAPI PRIVATE LIMITED

Meet No/Date:3/82-i

ALC4/2017

17.05.2017

Status:

Deferred

390 HQ File:01/82/050/01108/AM17/

RLA File'

:03/95/040/00659/AMI7/


14.12.2016

Defer Date:

08.11.2017

Decision: Deferred.

391

Case No.:213/17/82-

ALC4/2016

Party NameiCADILA'HEALTHCARE LTD

Meet No/Date:3/82-i

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:0I/82/050/01174/AM17/

RLA File

:08/24/040/00321/AM17/


15.12.2016

Defer Date:

08.11.2017

Decision: Deferred.

'392

Case No.:177/17/82-

ALC4/2016

Party Name:CAMPHOR &ALLIED PRODUCTS

LIMITED,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:0I/82/050/01138/AMI7/

RLA File

:03/94/040/00845/AMI7/


15.12.2016

Defer Date:

08.11.2017

Decision: Deferred.

393

Case No.:176/17/82-

ALC4/2016 ■

Party NameiGITANJALICHEMICALS PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01137/AM17/

RLA File

:03/94/040/00741/AM17/


15.12.2016

Defer Date:

08.11.2017

62

Decision: Deferred.

394

Case No.: 149/17/82-

ALC4/2016

Party NameiSTERLINGAUXILIARIES PVT LTD

Meet No/Datei3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/0 111 0/AM17/

RLA File

:03/95/040/00721/AM17/


15.12.2016

Defer Datei

08.11.2017

Decision: Deferred.

395

Case No.: 150/17/82-

ALC4/2016


Meet No/Datei3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01111/AM17/

RLA File

:03/95/040/00722/AMI7/


15.12.2016

Defer Datei

08.11.2017

Decision: Deferred.

396

Case No.:152/17/82-

ALC4/2ai6


Meet No/Datei3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01113/AM17/

RLA File

:03/95/040/00724/AM17/


15.12.2016

Defer Datei

08.II.20I7

Decision: Deferred.

397

Case No.:18/l/82-ALC4/2017 Party NameiFRESENIUSKABI ONCOLOGY LIMITED

Meet No/Datei3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01372/AM17/

RLA File

I05/23/040/00446/AM17/


16.12.2016

Defer Datei

08.11.2017

Decision: Deferred.

398

Case No.:48/l/82-ALC4/2017 Party NameiBENZO CHEMINDUSTRIES PRIVATE

LIMITED

Meet No/Datei3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01402/AM17/

RLA File

I03/94/040/00723/AM17/


19.12.2016

Defer Datei

08.11.2017

Decision: Deferred.

399

Case No.:49/l/82-ALC4/2D17 Party NameiBENZO CHEMINDUSTRIES PRIVATE

LIMITED

Meet No/Datei3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File:01/82/050/01403/AM17/

RLA File

I03/94/040/00725/AM17/


19.12.2016

Defer Datei

08.11.2017

Decision: Deferred.

400

Case No.:30/l/82-ALC4/2017 Party NameiSRIAM LABSPRIVATE LIMITED

Meet No/Datei3/82-

ALC4/2017

17.05.2017

Status:

Deferred

63

HQ File

:01/82/05q/01384/AM17/RLA File

:09/24/040/00508/AM17/Lic.No/Date:091006448820.12.2016

Defer Date:i

08.11.2017 '

Decision: Deferred.

1

,401

Case No.:46/l/82-ALC4/2017 Party NameiKRISHNAANTIOXIDANTS PVT. LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/82/050/01400/AMI7/RLA File

:03/94/040/00774/AM17/Lic.No/Date:03I081003621.12.2016

Defer Date:

08.11.2017


402

Case No.:124/l/82-ALC4/2017 Party Name:TORINORGANICS PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/82/050/01478/AMI7/RLA File

:35/24/040/00070/AM16/Lic.No/Date:3510045080

21.12.2016

Defer Date:

08.11.2017

• Decision: Deferred.

Case No.:123/I/82-ALC4/2017 Party Name:HETERO DRUGSLIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

,403HQ File

:0I/82/050/01477/AM17/RLA File

:09/24/040/00519/AM17/Lic.No/Date:091006450822.12.2016

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/130/2017-PI(Norms) dated 12.04.2017,,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Vol.1.RA concerned may take necessary action as per decision of NO.

404

Case No.:50/l/82-ALC4/2017 Party Nanie:CLARIANT'INDIA LIMITED

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File

:01/82/050/01404/AM17/RLA File'

;03/94/040/00881/AM17/Lic.No/Date:031081009923.12.2016

Defer Date:

08.11.2017

Decision: Deferred.

.

405

Case No.:125/l/82-ALC4/2017 Party Name:TORIN'ORGANICS PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/82/050/01479/AMI7/ilLA File

35/24/040/00045/AM17/Lic.No/Date:3 510045085


08.11.2017 '

Decision: Deferred.

—

dflK r

Case No.:61/I/82-ALC4/2017 Party Name:ADlSHANKCHEMICALS PVT.LTD.

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File01/82/050/01415/AM17/

File!03/94/040/00680/AM17/ :

Lic.No/Date:0310810150 ■

28.12.2016 (Defer Date:'

18.11.2017 '

Decision: Deferred.

64

4071

i

Case No.:94/l/82-ALC4/2017 Party Name:BIO TECHOPHTHALMICS PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

HQ File:01/82/050/01448/AM17/

RLA File

:08/24/040/00399/AM17/


28.12.2016

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/353/2016-PI(Norms) dated Sept. 2017,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Voi.l.RA concerned may take necessary action as per decision of NO.

408

Case No.:4/l/82-ALC4/2017 Party Name:RASULAPHARMACEUTICALS &

FINE CHEMICALS

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File;01/82/050/01358/AM17/

RLA File

:09/24/040/00509/AM17/


28.12.2016

Defer Date:

08.11.2017


409

Case No.:60/I/82-ALC4/2017 Party Name:AGIOPHARMACEUTICALS LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01414/AM17/

RLA File

:03/94/040/00836/AM17/


29.12.2016

Defer Date:

08.11.2017

Decision: Deferred.

410

Case No.:6/l/82-ALC4/2017 Party Name:INFlNITYLABORATORIES PVT.LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01360/AM17/

RLA File

:22/24/040/00083/AM17/


29.12.2016

Defer Date:

08.11.2017

Decision: Deferred.

'411

Case No.:58/l/82-ALC4/2017 Party Name:GlTANJALICHEMICALS PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01412/AM17/

RLA File

:03/94/040/00855/AM17/


03.01.2017

Defer Date:

08.11.2017


412

Case No.:32/l/82-ALC4/2017 Party Name:ALEMBICPHARMACEUTICALS LTD

Meet No/Date:3/82-,

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01386/AM17/

RLA File

:34/24/040/00268/AM17/


04.01.2017

Defer Date:

08.11.2017

Decision: Deferred.

413Case No.:59/l/82-ALC4/2017 Party Name:HEMA DYE

CHEM PVT. LTD.

Meet No/Date:3/82-

ALC4/2017

Status:

Deferred

65

17.05.2017

HQ File:01/82/050/01413/AM17/

RLA File

:03/94/040/00851/AM17/


04.01.2017

Defer Date:

08.11.2017

Decision: Deferred.

414

Case No.:22/l/82-ALC4/2017 Party Name:ASCENT'FINECHEM PVT. LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File,:01/82/050/01376/AM17/

RLA File,

;08/24/040/00388/AMI7/

Lic.No/Date:0810139477 ■

05.01.2017

Defer Date:,

08.11.2017 ,

Decision: Deferred.

Case No.:62/I/82-ALC4/2017 Party Name:CTXLIFESCIENCES PVT LTD,

1

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

415

HQ File:01/82/050/014I6/AMI7/

RLA Filei:03/94/040/00854/AM17/ '

Lic.No/Date:0310810349 !05.01.2017

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/o|Pharmaceuticals forwarded vide O.M. No. 35011/206/2014-PI(Norms) dated Oct. 2014 uploadedlat the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP'Vol.1.RA concerned may take necessary action as per decision of NO.

416

Case No.:53/l/82-ALC4/2017 Party Name:CIPLA LIMITED. Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01407/AM17/

RLA File;:03/94/040/00915/AM17/


06.01.2017

Defer Date:'

08.11.2017

i Decision : Deferred.

Case No.:26/l/82-ALC4/2017 Party Name:HETERO DRUGSLIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

:4i7'

HQ Filei:01/82/050/0I380/AM17/

RLA File'

:09/24/040/00533/AM17/


06.01.2017

Defer Date:

Decision :The Committee decided to ratify norms based on the recommendation of D/o'Pharmaceuticals fonvarded vide O.Wl. No. 35011/494/2012-PI(Norms) dated 17.10.2012,'uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Vol.l.RA concemed may take necessary action as per decision of NC.

418

Case No.:56/l/82-ALC4/2017 Party Name:GLENMARKPHARMACEUTICALS LTD.,

Meet No/Date:3/82-,

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:0I/82/050/01410/AMI7/

RLA File

:03/94/040/00822/AM17/


09.01.2017

Defer Date:

08.11.2017

Decision: Deferred.

419

Case No.:55/l/82-ALC4/2017 Party Name:AARTI DRUGSLIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

66

HQ File:01/82/050/01409/AM17/

RLA File'

:03/94/040/00900/AM17/


11.01.2017

Defer Date:

08.11.2017

Decision: Deferred.

420

Case No.:54/l/82-ALC4/2017 Party Name:AARTIINDUSTRIES LIMITED

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File:0I/82/050/01408/AM17/

RLA File

:03/94/040/00805/AM17/

Lic.No/Date:03I0810483 '

12.01.2017

Defer Date:

08.11.2017

Decision: Deferred.

421

Case No.:27/l/82-ALC4/2017 Party NameiCADILA'HEALTHCARE LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01381/AM17/

RLA File

:08/24/040/00323/AM17/


12.01.2017

Defer Date:

08.11.2017

Decision: Deferred.

422

Case No.:63/l/82-ALC4/2017 Party NameiFINE ORGANICINDUSTRIES PVT. LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01417/AM17/

RLA File

:03/94/040/0G919/AM17/


12.01.2017

Defer Date:

08.11.2017

Decision: Deferred.

423

Case No.:28/l/82-ALC4/2017 Party Name:CADlLAHEALTHCARE LTD

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File:01/82/050/01382/AM17/

RLA File

:08/24/04D/00430/AM17/


13.01.2017

Defer Date:

08.11.2017

Decision: Deferred.

424

Case No.:52/l/82-ALC4/2017 Party NameiCIPLA LIMITED. Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01406/AM17/

RLA File

;03/94/D40/00942/AM17/


13.01.2017

Defer Date:

08.11.2017


425

Case No.:64/l/82-ALC4/2017 Party Name:KAIRAVCHEMOFARBE INDUSTRIES

LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01418/AM17/

RLA File

:03/94/040/00918/AM17/


13.01.2017

Defer Date:

08.11.2017

Decision: Deferred.

426 |Case No.:25/l/82-ALC4/2017 Party Nanie:AUROBINDO Meet No/Date:3/82- Status:

67

PHARMA LIMITED ALC4/20I7

17.05.2017

Deferred

HQ Filel:01/82/050/01379/AM17/

RLA File!

:09/24/040/00550/AM17/


16.01.2017

Defer Date:

08.11.2017

Decision: Deferred.

427

Case No.:n5/l/82-ALC4/2017'Party Name:BIO TECH|OPHTHALMICS PVT LTD !

(

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status;

Deferred

HQ File:01/82/050/01469/AMI7/

RLA Filei

:08/24/040/00381/AM17/


16.01.2017

Defer Date:'

08.11.2017

Decision: Deferred.

428

Case No.:21/l/82-ALC4/2017 , Party Name:PCL OIL &|SOLVENTS LTD.,

Meet No/Date:3/82-[ALC4/20I7

17.05.2017

Status:

Deferred

HQ File,:01/82/050/01375/AM17/

RLA Filei

:05/24/040/00506/AM17/

Lic.No/Date:05I0401302 ■

16.01.2017

Defer Date:

08.11.2017

Decision: Deferred.

429

Case No,:34/I/82-ALC4/2017 Party NameiREINEiLIFESCIENCE

Meet No/Date;3/82-'

ALC4/2017 '17.05.2017

Status: ,

Deferred

HQ File:01/82/050/01388/AM17/

RLA File:

:34/24/040/00276/AM17/

Lic.No/Date:3410042838 '

16.01.2017

Defer Date:i

08.11.2017

Decision: Deferred.

Case No.:7/l/82-ALC4/2017 Party NameiSUN,PHARMACEUTICAL

INDUSTRIES LTD., ,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

430.

HQ File!

:01/82/050/01361/AM17/ _ ;RLA Filei

:05/24/040/00475/AM17/ !Lic.No/Date:0510401297 '

16.01.2017

Defer Date: i

Decision : The Committee decided to ratify norms based on the recommendation of D/oiPharmaceuticais forwarded vide O.M. No. 35011/96/2012-PI(Norms) dated July 2012, uploaded,at the end of these minutes and import item at Si.No.1, 3 to 14 aiiowed on^ prorate basis or as'applied by the firm whichever is iess under para 4.07 of HBP VoI.I.RA concerned may takenecessary action as per decision of NO.

431,

Case No.:33/l/82-ALC4/2017 Party Name:SUPERINDUSTRIAL LINING PVT'

LTD

Meet No/Date:3/82-'

ALC4/2017

17.05.2017

Status:

Deferred '

HQ File:01/82/050/01387/AMi7/

RLA File,:34/24/040/00288/AMI7/ ■


16.01.2017

Defer Date:'

08.11.2017

Decision: Deferred._ j

432

Case No.:69/l/82-ALC4/2017 Party Name:KOPRAN'RESEARCH

LABORATORIES LTD.

Meet No/Date:3/82-i

ALC4/2017

17.05.2017

Status:

Approved

68

HQ File

:01/82/050/01423/AM17/

RLA File.

:03/94/040/00949/AM17/


17.01.2017

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/296/2012-PI(Norms) dated Sept. 2012,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Vol.1.RA concerned may take necessary action as per decision of NO.

4331

Case No.:24/I/82-ALC4/2017 Party Name:SUNPHARMACEUTICAL

INDUSTRIES LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/OI378/AM17/

RLA File

:05/24/040/00508/AMI7/


17.01.2017

Defer Date:

08.11.2017

Decision: Deferred.

434

Case No.:67/l/82-ALC4/2017 Party Name:BDRPHARMACEUTICALS

INTERNATIONAL PVT. LTD.

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Approved

HQ File;01/82/050/0142I/AM17/

RLA File

:03/94/040/00950/AM17/


19.01.2017

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/168/2016-PI(Norms) dated27th March 2017,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Vol.1 .RA concerned may take necessary action as per decision of NC.

435

Case No.:68/l/82-ALC4/2017 Party Name:GOPALDASVISRAM & CO.LTD.

Meet No/Date:3/82-i

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01422/AM17/

RLA File

:03/94/040/00966/AM17/


19.01.2017

Defer Date:

08.11.2017

Decision: Deferred.

436

Case No.:38/l/82-ALC4/2017 , Party Name:BELCHEM INDS.INDIA PVT. LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File;0I/82/050/01392/AM17/

RLA File

:03/94/040/00699/AM17/


23.01.2017

Defer Date:

08.11.2017

Decision: Deferred.

437

Case No.:I14/l/82-ALC4/2017 Party Name:BIO TECHOPHTHALMICS PVT LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01468/AM17/

RLA File

:08/24/040/00379/AM17/


25.01.2017

Defer Date:

08,11.2017

Decision: Deferred.

438

Case No.:3/l/82-ALC4/2017 Party Name:DHANUKALABORATORIES LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred


69

: :01/82/050/01357/AM17/ :05/23/040/00507/AM17/ 25.01.2017 08.11.2017

.Decision : Deferred.

i4391

Case No.:65/l/82-ALC4/2017 Party Name:K V AROCHEMPVT. LTD

.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File;01/82/050/01419/AM17/

RLA File

:03/94/040/00976/AM17/Lic.No/Date:0310810753

25.01.2017

Defer Date:

08.11.2017

, ,Decision: Deferred.

.

^40

Case No.:2/l/82-ALC4/2017 Party Name:ALKAL01DSCORPORATION

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:

:0I/82/050/01356/AM17/

RLA File

:02/24/040/00216/AM17/Lic.No/Date:0210207287

27.01.2017

Defer Date:

08.11.2017


Case No.:39/l/82-ALC4/2017 Party NameiNECTARLIFESCIENCES LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

441.

HQ File

:0I/82/050/01393/AMI7/RLA File,

:22/24/040/00097/AMI7/Lic.No/Date:221001563827.01.2017

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/o!Pharmaceuticals forwarded vide O.M. No. 35011/13/2Q14-PI(Norms) dated Sept 2014, uploadediat the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBPVol.1 .RA concerned may take necessary action as per decision of NO.

442

Case No.;113/l/82-ALC4/2017i Party Name:CORONAiREMEDIES PRIVATE

LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File!

:01/82/050/01467/AM17/RLA File!:08/24/040/00387/AM17/


30.01.2017


Decision: Deferred.

443

CaseNo.:13/l/82-ALC4/2017 j Party Name:MEDICAMEN!BIOTECH LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/82/050/01367/AMI7/RLA File,

:05/24/040/00543/AMI7/ 'Lic.No/Date:051040142131.01.2017

Defer Date:

08.11.2017


_

444

CaseNo.:95/l/82-ALC4/2017 'Party Name:CADILAiPHARMACEUTICALS LTD.

VIeet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File,0I/82/050/01449/AM17/

■ILA File08/24/040/00449/AM17/

Lic.No/Date:0810139633 '01.02.2017



70

445

Case No.:105/l/82-ALC4/2017 Party NameiCADILAHEALTHCARE LTD

Meet No/Datei3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01459/AM17/

RLA File

;08/24/040/00451/AM17/


02.02.2017

Defer Datei

08.11.2017

Decision: Deferred.

446

Case No.:108/l/82-ALC4/2017 Party NameiCADILAHEALTHCARE LTD

Meet No/Datei3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File;01/82/050/01462/AM17/

RLA File,

:08/24/040/00450/AM17/

Lic.No/Datei08I0139643

02.02.2017

Defer Datei

08.11.2017

Decision: Deferred.

447,

Case No.:16/l/82-ALC4/2017 Party NameiJUBILANT LIFESCIENCES LIMITED

Meet No/Datei3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File

:Dl/82/050/01370/AM17/

RLA File

:05/23/040/00431/AM17/


02.02.2017

Defer Date:

08.11.2017

Decision: Deferred.

448

Case No.:14/l/82-ALC4/2017 Party NameiPAYALPOLYPLAST PRIVATE

LIMITED

Meet No/Date:3/82-'

ALC4/2017

17.05.2017

Status:

Deferred

HQ File;01/82/050/01368/AM17/

RLA File

;05/24/040/00468/AM17/


02.02.2017

Defer Date:

08.11.2017


449

Case No.:15/l/82-ALC4/2017 Party NameiPAYALPOLYPLAST PRIVATE

LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01369/AM17/

RLA File

I05/24/040/0D493/AM17/


02.02.2017

Defer Date:

08.11.2017

Decision: Deferred.

450

Case No.:8/l/82-ALC4/2017 Party NameiHPL ADDITIVESL1MITED(F0RMERLYKNOWN HIGH POLYMER

Meet No/Datei3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:01/82/050/01362/AM17/

RLA File

I05/23/040/00458/AMI7/


03.02.2017

Defer Date:

08.11.2017


4511

Case No.:10/l/82-ALC4/2017 Party NameiJODAS EXPOIMPVT.LTD.,

Meet No/Datei3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File

:0I/82/050/0I364/AM17/

RLA File

I05/23/040/0D521/AM17/


03.02.2017

Defer Date:

08.11.2017

Decision: Deferred.

71

Case No.:9/l/82-ALC4/2017 Party Name:KLJ ORGANICLTD

VIeet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

At>2 HQ File!:01/82/050/01363/AM17/

RLA File

:05/23/040/00520/AMI7/


03.02.2017

Defer Date:

08.II.20I7

Decision: Deferred.

453

Case No.: 12/1/82-ALC4/2017 Party Name:PAYALPOLYPLAST private!LIMITED S

Meet No/Date:3/82-

ALC4/2017-

17.05.2017 !

Status:

Deferred

HQ Filei:01/82/050/01366/AM17/

RLA File,;05/24/040/00504/AM17/

Lic.No/Date:0510401484 '03.02.2017

Defer Date:,

08.11.2017 ■


454

Case No.:117/l/82-ALC4/2017!Party Name:CADILA,HEALTHCARE LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01471/AM17/

RLA File

:08/24/040/00452/AM17/


06.02.2017

Defer Date:

08.11.2017


455

Case No.:116/l/82-ALC4/2017 Party Name:CADILAiHEALTHCARE LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01470/AM17/

RLA File

:08/24/040/00453/AM 17/


07.02.2017

Defer Date:

08.11.2017


456,

Case No.:41/l/82-ALC4/2017 Party NameiGODAVARIDRUGS LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File':01/82/050/01395/AM17/

RLA File>

:09/24/040/00607/AM17/


07.02.2017

Defer Date:

08.11.2017

Decision: Deferred.

457

Case No.:98/l/82-ALC4/2017 Party Name:lND-SWIFTLABORATORIES LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01452/AM17/

RLA File

:22/24/040/00I01/AM17/


07.02.2017

Defer Date:

08.11.2017

Decision: Deferred.

^458

Case No.:112/l/82-ALC4/2017 Party NameiDR. REDDYSLABORATORIES LIMITED

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Approved

HQ File;01/82/050/0I466/AM17/

RLA File

:09/24/040/00573/AM17/


08.02.2017

Defer Date:

72

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/293/2014-PI(Norms) dated November 2014,uploaded at the end of these minutes or as applied by the firm whichever Is less under para 4.07of HBP Vol.1 .RA concerned may take necessary action as per decision of NO.

459

Case No.:n/l/82-ALC4/2017 Party Name:SUN'PHARMACEUTICAL

INDUSTRIES LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01365/AM17/

RLA File^

:05/24/040/00557/AM17/


08.02.2017

Defer Date:

08.11.2017


460

Case No.:96/l/82-ALC4/2017 , Party Name:AMI ORGANICS^PVT LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:0I/82/050/0I450/AM17/

RLA File

:52/24/040/00075/AM]7/


10.02.2017

Defer Date:

08.11.2017


461

Case No.:97/l/82-ALC4/2017 Party Name:AMI ORGANICSPVT LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01451/AM17/

RLA File':52/24/040/00076/AM17/

Lic.No/Date:5210042176 '

10.02.2017

Defer Date:

08.11.2017

Decision: Deferred.

462

Case No.:17/l/82-ALC4/2017 Party Name:MOREPENLABORATORIES LTD.,

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Approved

HQ File:01/82/050/01371/AM17/

RLA File

:05/24/040/00576/AM17/


13.02.2017

Defer Date:

Decision ; The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/378/2016-PI{Norms) dated 8th Sept. 2017,'uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07,of HBP Vol. 1. RA concerned may take necessary action as per decision of NC.

463

Case No.:110/l/82-ALC4/2017 Party Name:JUBILANT LIFESCIENCES LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01464/AMI7/

RLA File

:05/23/040/00499/AM17/


14.02.2017

Defer Date:

08.11.2017


464

Case No.:120/l/82-ALC4/2017 Party Name:DEEPAKNOVOCHEM

TECHNOLOGIES LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01474/AMI7/

RLA File

:31/83/040/00136/AM17/


15.02.2017

Defer Date:

08.11.2017 ^

73


Case No.:l 11/1/82-ALC4/2017; Party Name:JUBILANTjGENERICS LTD

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

4bb HQ File01/82/050/01465/AM17/

RLA File'.05/23/040/00530/AM17/


15.02.2017

Defer Date:

08.11.2017

Decision: Deferred.

466

Case No.:107/l/82-ALC4/2017,Party Name:SCOTT EDIL'ADVANCE RESEARCH LAB,

AND EDU LTD

Meet No/Date:3/82-^

ALC4/2017

17.05.2017

Status:

Deferred

HQ File;:01/82/050/01461/AM17/ ,

RLA File

:22/24/040/00105/AM17/

Lic.No/Date:2210015655 ,15.02.2017

Defer Date:,

08.11.2017 '


467:

Case No.: 106/1/82-ALC4/2017'Party Name:PARAMOUNT'AROMACHEM PVT.LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ Filej;01/82/050/01460/AM17/ 1

RLA File:

:05/24/040/00581/AM17/

Lic.No/Date:051040I672 ;

16.02.2017

Defer Date:;

08.11.2017 ,


468

Case No.;109/l/82-ALC4/2017 Party NameiHELLO PAINTS(P) LTD

i

Meet No/Date:3/82-

ALC4/2017

17.05.2017 I

Status:

Deferred

HQ File:01/82/050/01463/AM17/

RLA File:;05/23/040/00559/AM17/

Lic.No/Date:0510401721 ■

20.02.2017

Defer Date:'

08.11.2017

1 Decision: Deferred.

Case No.:119/l/82-ALC4/2017 Party NameilNTASPHARMACEUTICALS LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved .

469

HQ File:01/82/050/01473/AM17/

RLA File

;08/24/040/00471/AM17/


22.02.2017

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/o'Pharmaceuticals forwarded vide O.M. No. 35011/814/2014-PI(Norms) dated August 2014,'uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Vol.1.RA concerned may take necessary action as per decision of NO.

Case No.:100/l/82-ALC4/2017 Party NameiMAHIMA LIFESCIENCES PVT.LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

470HQ File:01/82/050/01454/AM17/

RLA File

:05/24/040/00587/AM17/


23.02.2017

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/222/2016-PI(Norms) dated Sept. 2017,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07'

74

of HBP Vol.1.RA concerned may take necessary action as per decision of NC.

Case No.:101/I/82-ALC4/2017 Party NameiMAHIMA LIFESCIENCES PVT.LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

471

HQ File

:01/82/050/01455/AMI7/

RLA File

:05/24/040/00586/AM17/

Lic.No/Date:051040178023.02.2017

Defer Date:

08.11.2017

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/729/2015-PI(Norms) dated 27.4.2016, uploadedat the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBPVoI.I.RA concerned may take necessary action as per decision of NC.

Case No.:102/l/82-ALC4/2017 Party Name:SENTISSPHARMA PVT.LTD.

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Approved

472'

HQ File

:01/82/050/01456/AM17/

RLA File

:05/24/040/00600/AM17/


23.02.2017

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/281/2016-PI(Norms) dated 15.09.2017, uploaded at the end ofthese minutes or as applied by the firm whichever is less under para 4.07 of HBP VoI.I.RAconcerned may take necessary action as per decision of NC.

473

Case No.:103/l/82-ALC4/20I7 Party Name:SWATIMENTHOL & ALLIED

CHEMICALS LTD.,

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Deferred

HQ File

:01/82/050/01457/AMI7/

RLA File

:29/24/040/00009/AMI7/


23.02.2017

Defer Date:

08.11.2017


474

Case No.:104/l/82-ALC4/2017 Party Name:SWATlMENTHOL & ALLIED

CHEMICALS LTD.,

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01458/AM17/

RLA File

:29/24/040/00008/AM17/Lic.No/Date:2910025280

23.02.2017

Defer Date:

08.11.2017


475

Case No.:122/l/82-ALC4/2017 Party Name:ARIHANTSIDDHAR LABORATORIES

PVT.LTD

Meet No/Date;3/82-

ALC4/2017

17.05.2017

Status:

Deferred

HQ File:01/82/050/01476/AM17/

RLA File

:31/83/040/00162/AM17/


28.02.2017

Defer Date:

08.11.2017

Decision: Deferred.

476

Case No.:99/l/82-ALC4/2017 Party Name:MAHIMA LIFESCIENCES PVT.LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

HQ File

■.01/82/050/01453/AM17/RLA File:05/24/040/00592/AM17/

Lic.No/Date:051040179428.02.2017

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/o

75

Pharmaceuticals forwarded vide O.M. No. 35011/28/2013-Pl(Norms) dated April 2015 uploaded!at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBPVol.1.RA concerned may take necessary action as per decision of NC. ^

Case No.:121/l/82-ALC4/2017,Party NameiCLEAN SCIENCE,AND TECHNOLOGY'PVT.LTD. ;

Meet No/Date:3/82-iALC4/2017

17.05.2017

Status:

Deferred

4/7 HQ Filel:01/82/050/01475/AM17/

RLA File!:31/83/040/00168/AM17/


02.03.2017

Defer Date:'

08.11.2017 ,

Decision: Deferred.

<:ase No.:23/l/82-ALC4/2ai7 , 1̂ arty Name:V.D.H. 1DRGANICS PVT. LTD ;

V4eet No/Date:3/82- 1\LCM2m

17.05.2017

Status:

)eferred

478 ■HQ File'01/82/050/01377/AM17/

RLA Filei05/24/040/00531/AM17/


33.03.2017

Defer Date:

38.11.2017

Decision : Deferred. . .

Case No.:l/l/82-ALC4/2ai7 , Party Name:JUBILANT LIFE,SCIENCES LIMITED


17.05.2017

Status:

Deferred ,

479 HQ File:01/82/050/01355/AM17/

RLA File.:05/23/040/00553/AM17/


09.03.2017

Defer Date:'

08.11.2017

Decision: Deferred.

.

Case No.:l/3/82-ALC4/2017 Party Name;DIVISLABORATORIES LTD


17.05.2017

Status:

Approved

480

HQ File:01/82/050/00002/AMI8/

RLA File:09/24/040/00014/AM18/


21.04.2017

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/209/2016-PI(Norms) dated Sept. 2016.uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

-

Case No.:3/3/82-ALC4/2ai7 Party Name:CADILAHEALTHCARE LTD

Meet No/Date:3/82-

ALC4/20I7

17.05.2017

Status:

Approved

481

HQ File:01/82/050/00004/AM18/

RLA File:08/24/040/00007/AM18/


24.04.2017

Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/o,Pharmaceuticals forwarded vide O.M. No. 35011/289/2016-PI(Norms) dated September 2017,,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07'of HBP Vol.1.RA concerned may take necessary action as per decision of NC

482

Case No.:2/3/82-ALC4/2017 Party Name:SRIAM LABSPRIVATE LIMITED

Meet No/Date:3/82-

ALC4/2017

17.05.2017

Status:

Approved

HQ File,RLA File Lic.No/Date:0910064939 Defer Date:

76

:01/82/050/00003/AM18/ :09/24/040/00697/AM17/ '24.04.2017 ^

Decision : The Committee decided to ratify norms based on the recommendation of D/oiPharmaceuticals forwarded vide O.M. No. 35011/97/2015-PI(Norms) dated August 2015,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Vol.1.RA concerned may take necessary action as per decision of NO

Case No.:4/3/82-ALC4/2017 Party Name:SRIAM LABSiPRIVATE LIMITED

Meet No/Date:3/82-|ALC4/2017

17.05.2017 ^ :

Status:

Approved '

1

4831

HQ File:01/82/050/00005/AM18/

RLA File

;09/24/040/00698/AM17/

Lic.No/Date:0910064941 ,24.04.2017

Defer Date:

1

1

1

Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M. No. 35011/757/2015-PI(Norms) dated 2nd May 2016, uploaded at the endof these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NC.

1 Case No.:6/3/82-ALC4/2017 Party NameiHETERO LABSlLIMITED

Meet No/Date:3/82-'

ALC4/2017

17.05.2017

Status:

Approved

484

HQ File:01/82/050/00007/AM18/

RLA File

:09/24/040/00053/AMI8/


01.05.2017

Defer Date:

•

Decision : The Committee decided to ratify norms based on the recommendation of D/o>Pharmaceuticals O.M. No. 35011/226/2014-Pl(Norms) dated Oct. 2014, uploaded at the end of,these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NC

485!

Case No.:5/3/82-ALC4/2017 Party Name:PCL OIL &SOLVENTS LTD.

Meet " No/Date:3/82-'

ALC4/2017

17.05.2017 i

Status:

Deferred

HQ File,:01/82/050/00006/AM18/

RLA File

;05/24/040/00043/AMI8/


01.05.2017 ,Defer

Date:08.11.2017

1

Decision: Deferred.

486

Case No.:225/I3/82-

ALC4/2014

Party Narae:DELTA.FINOCHEM PVT.LTD.

Meet No/Date:3/82-

ALC4/2017

17.05.2017J

Status:

Deferred

HQ File:01/82/050/01228/AM15/

RLA File

:03/94/040/00397/AM15/


28.08.2014

Defer Date:

08.11.2017

Decision: Deferred.

487

Case No.:7/3/82-ALC4/20I7 Party Name:KAIRAVCHEMOFARBE

INDUSTRIES LTD.

Meet No/Date:3/82-'

ALC4/2017

17.05.2017

Status:

Deferred

HQ File,:01/82/050/00008/AM18/

RLA Filei:03/94/040/00075/AM18/


05.05.2017

Defer ;Date:08.11.2017!

'Decision: Deferred.

77

Manual Agenda of NC Meeting No. 03/82/2017Scheduled to be held on 25.09.2017

Case No. B- 01M.No.OS/AWl-lB

Date 25.09.2017

M/s. RA Chem Pharma LtdFile No. 01/82/050/00857/AM 16

RLA NO.09/24/040/00045/AM 16Adv.Auth. No. 0910062053 dated. 21.05.2015Adv.Auth. No. 0910061970 dated. 01.05.2015

Decision; The Committee considered this case for revision of norms as per agenda. IheCommittee decided to revised norms based on the recommendation of D/o PharmaceuticalsO.M.No.35011/682/2015-PI(Norms) dated 22.3.2016, uploaded at the end of these minutes or asapplied by the firm whichever is iess. RA concerned may take further necessary action as per thedecision of NC.

Case No. B- 02

M.NO.03/AM-18

Date 25.09.2017

M/s. RA Chem Pharma Ltd

File No. 01/82/050/00363/AM 16

RLA NO.09/24/040/00559/AM 15

Adv.Auth. No. 0910061477 dated. 02.01.2015

Decision: The Committee considered this case for correction in description of import item as peragenda. The Committee decided correct the description of import item to read as "3-Amlno-4-Methyl-2-thiophene Carboxylic Acid Methyl Ester" without any other change. RA concernedmay take further necessary action as per the decision of NC.

Case No. B- 03

M.NO.03/AM-18

Date 25.09.2017

M/s. Organica Aromatics Pvt LtdFiie No. 01/82/050/01105/AM 12

RLA NO.07/24/040/00314/AM 12

Adv.Auth. No. 0710084171 dated. 23.11.2011

Decision: The Committee considered this case for ratification of norms as per agenda. TheCommittee decided to ratify norms on repeat basis as per the eariier decision of NC meetingNo.15/82 dated 07.07.2009, uploaded at the end of these minutes or as appiied by the firmwhichever is less. RA concerned may take further necessary action as per the decision of NC.

Case No. B- 04

M.NO.03/AM-18

Date 25.09.2017

M/s. KLJ Plasticizers Ltd

File No. 01/82/050/00280/AM 15

RLA NO.05/23/040/00536/AM 14

Adv.Auth. No. 0510383274 dated. 01.04.2014

Decision: The Committee considered this case for revision of norms as per agenda. TheCommittee decided to send copy of application to DIPP (Chemical) for comments and deferredthe case.

Case No. B- 05 M/s. RA Ghem Pharma

78

M.NO.03/AM-18

Date 25.09.2017

File No. 01/82/050/00651/AM 15

Adv.Auth. No. 0910055973 dated. 09.05.2013

Adv.Auth. No. 0910057516 dated. 10.09.2013

Adv.Auth. No. 0910059417 dated. 25.02.2014

Decision: The Committee considered this case for revision of norms as per agenda. TheCommittee decided to send a copy of application to D/o Pharmaceuticals for comments anddeferred the case.

Case No. B- 06

M.No.03/A!\/l-18

Dale 25.09.2017

M/s. Tide Industries

File No. 01/82/050/00531/AMIS

RLA F.No 34/24/040/00138/AIV115Adv.Aulh. No. 3410040551 dated 15.09.2014

Decision: The Committee considered this case for ratification of norms as per agenda. TheCommittee decided to ratify norms on repeat basis based on the recommendation of D/o C&PCU.O.No.14010/40/2011-Ch-ll dated 04.03.2016, uploaded at the end of these minutes or asapplied by the firm whichever is less. RA concerned may take further necessary action as per thedecision of NC.

Case No. B- 07

M.No.03/Al\/l-18

Date 25.09.2017

M/s. Tide industries

File No. 01/82/050/00458/AM 16

RLA No.34/24/040/00310/AM15

Adv.Auth. No. 3410040978 dated. 23.02.2015

Decision: The Committee considered this case for ratification of norms as per agenda. TheCommittee decided to ratify norms on repeat basis based on the recommendation of D/o C&PCU.O.No.14010/40/2011-Ch-ll dated 04.03.2016, uploaded at the end of these minutes or asapplied by the firm whichever is less. RA concerned may take further necessary action as per thedecision of NC.

Case No. B- 08

M.NO.03/AM-18

Date 25.09.2017

M/s. H.J. Arochem (P) LtdFile No. 01/82/050/01484/AM 15

RLA No.08/24/040/00341/AM15

Adv.Auth. No. 0810134067 dated. 16.12.2014

Decision: The Committee considered this case for ratification of norms as per agenda. TheCommittee decided to send a copy of application to DIPP ((Chemical) for comments and deferredthe case.

Case No. B- 09

M.NO.03/AM-18

Date 25.09.2017

M/s KLJ Piasticlzers Ltd

File No. 01/82/050/00772/AM 11

RLA No.05/23/040/00078/ AM11

Adv.Auth. No. 0510267557 dated. 06.07.2010

Decision: The Committee considered this case for amendment in description of import item as peragenda. The Committee decided to send a copy of application to C&PC for comments anddeferred the case.

79

Case No. B-10

M.NO.03/AM-18

Date 25.09.2017

Mis Aurobindo Pharma Ltd

File No. 01/82/050/01164/AM 17

RLA No.09/24/040/00330/AM17

Adv.Auth. No. 0910064257 dated. 10.10.2016

Decision: The Committee considered this case for revision of norms as per agenda. TheCommittee decided to revise the norm based on the recommendation of D/o PharmaceuticalO.M.No.35011/173/2016-Pl(Norms) dated 26.09.2016. upioaded at the end of these minutes oras applied by the firm whichever is less. RA concerned may take further necessary action as perthe decision of NC.

Case No. B-11

M.NO.03/AM-18

Date 25.09.2017

M/s Fresenius Kabi Oncology LtdFile No. 01/82/050/00788/AM 17

RLA No.05/23/040/00252/ AMI 7

Adv.Auth. No. 0510399569 dated. 29.08.2016

Decision: The Committee considered this case for revision of norms as per agenda. TheCommittee decided to send a copy of application to D/o Pharmaceuticals for comments anddeferred the case.

Case No. B-12

M.NO.03/AM-18

Date 25.09.2017

M/s Aarti industries Ltd

Fiie No. 01/82/050/00411/AM 16

RLA No.03/94/040/00882/AM15

Adv.Auth. No. 0310792412 dated. 29.12.2014

Decision: The Committee considered this case for ratification of norms as per agenda. TheCommittee decided to send a copy of application to DlPP(Chemical) for comments and deferredthe case.

Case No. B-13

M.NO.03/AM-18

Date 25.09.2017

M/s Enaltec Labs Pvt Ltd

Fiie No. 01/82/050/01820/AM 16

RLA No.03/94/040/00906/AM16

Adv.Auth. No. 0310802288 dated. 08.02.2016

Decision: The Committee considered this case for correction in description of import items as peragenda. The Committee decided to amend the description of import items as mentioned inadvance authorisation. RA concerned may take further necessary action as per decision of NC.

Case No. B-14

M.NO.03/AM-18

Date 25.09.2017

M/s Maghmani LLPFiie No. 01/82/171/00353/AM 17

Decision: The Committee considered this case for revision of SION A-343 and A-3488 published

80

for 'Paracetamole' as per agenda.

The Committee recommended to revise SION A-343 and A-3488 as per recommendation of D/oPharmaceuticals O.I\/I.No.35011/351/2016-PI(Norms) dated 07.04.2017 as per details givenbelow:-

SION No. Qty. OfParacetamole

Description of Raw Materials Existingqty.

Revised

qty.

A-343 1kg 1. Phenol 1.1kg 1.1kg

2. Sodium Nitrite G.95kg 0.95kg

3. Acetic Anhydride 0.95kg 0.75kg

A-3488 1kg 1. Para Amino Phenol 0.91kg 0.80kg

2. Acetic Anhydride 0.85kg 0.75kg

The above modification/revision of SIONs would be effect from date of issue of Public Notice.

Case No. B-15

M.NO.03/AM-18

Date 25.09.2017

M/s. H.J. Arochem (P) LtdFile No. 01/82/050/01268/AM 15

RLA No.08/24/040/00265/ AM15

Adv.Auth. No. 0810133768 dated. 10.11.2014

Decision: The Committee considered this case for ratification of norms as per agenda. TheCommittee decided to send a copy of application to DlPP(Chemical) for comments and deferredthe case.

Case No. B-16

M.NO.03/AM-18

Date 25.09.2017

M/s. Jubilant Life Sciences Ltd

File No. 01/82/050/00431/AM 17

RLA No.05/23/040/00172/AM17

Adv.Auth. No. 0510398972 dated. 04.07.2016

Decision: The Committee considered this case for correction In export product of norms as peragenda. It is decided to refer the case to DIPP (Chemical) of their comments and deferred thecase.

Case No. B-17

M.NO.03/AM-18

Date 25.09.2017

M/s. Jubilant Life Sciences Ltd

File No. 01/82/050/00431/AM 16

RLA No.05/23/040/00544/AM15

Adv.Auth. No. 0510393616 dated. 18.03.2015

Decision: The Committee considered this case for correction in the export products as per agendaand decided to refer the case to DlPP(Chemical) and deferred the case.

Case No. B-18

M.NO.03/AM-18

Date 25.09.2017

M/s. Jubilant Generics Ltd

File No. 01/82/050/00885/AM 17

RLA No.05/23/040/00299/AM17

Adv.Auth. No. 0510400077 dated. 07.10.2016

Decision: The Committee considered this case for correction in the norms as per agenda. TheCommittee decided to correction/amend the description of export product to read as"Tables/Capsules" as per the request. RA concerned may take further necessary action as perthe decision of NC.

81

Case No. B-19

M.NO.03/AIVI-18

Date 25.09.2017


File No. 01/82/050/00421/AM 17

RLA No.05/23/040/00076/ AM17

Adv.Auth. No. 0510398582 dated. 24.05.2016

Decision: The Committee considered this case for correction in the norms as per agenda. TheCommittee decided to send copy of application to DoP and deferred the case.

Case No. B- 20

M.NO.03/AM-18

Date 25.09.2017


File No. 01/82/050/00890/AM 17RLA NO.05/23/040/00298/AM17

Adv.Auth. No. 0510400076 dated. 07.10.2016

Decision: The Committee considered this case for correction in the norms as per agenda. TheCommittee decided to send copy of application to DoP and deferred the case.

Case No. B- 21

M.NO.03/AM-18

Date 25.09.2017


File No. 01/82/050/00891/AM 17RLA NO.05/23/040/00323/AM17Adv.Auth. No. 0510400088 dated. 13.10.2016

Decision. 1 he Committee considered this case for amendment in the norms as per agenda. TheCommittee decided to maintain status quo.

82

F. No.35011/420/2014-Pi (Norms)Government of India

Ministry of Chemical & FertilizersDepartment of Pharmaceuticals

Office Memorandum

2c

Udyog Bhawan, New Delhi,Dated: June, 2016

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/sUnited Biotech Pvt. Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/323/AM-15/DES-3/454 datedthe 30/7/14 vide which application from M/s United Biotech Pvt. Ltd. was sent to this Department forfixation of norms under para: 4.7 for the. export of Ticarcillin and Clavulanic Acid Injection in3.2gm and 1.6gm strengths. This department has examined the matter and the following norms arefurnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-

S.No. Import item Norms Recommended

1 Ticarcillin Disodium and Pot Clavulanate (15:1) 1.68gm/1.60gm vialAnd

3.36gm/3.20gm vial

2. This issues with the approval of competent authority.

(Rajkumar)Under Secretary to the Government of India

PH:-23071162

Directorate General of Foreign Trade.Department of Commerce,(Shri M.V. Singh, FTDO).Udyog Bhawan, New Delhi

F. No.35011/36/2015-PI (Norms)Government of India

Ministry of Chemicals & FertilizersDepartment of Pharmaceuticals

Udyog Bhavvan,New Delhi,Dated the June, 2015

Office MemorandumSubject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14Case ofM/sHetero Labs Ltd. ^

3/962 dit'ed 01/82/50/1058/AM-15/DES-0/962 dated the 06/01/15 vide which application from M/s. Hetero Labs Ltd was sent to this

SSdrL Th ""''i'"' ""der.para: 4.7 for the export of LevofloxacinHemihydrate. This department has examined the matter and the following norms arefurnished under nnra 4 7 nf T-Ttin^ a /tt.i ,s ® die

S.No. Import Item Qty. Recommended kg/kg.

1.

Ethyl(S)-9,10-Difluoro-3-Methyl-7-Oxo-2,3-

Dihydro-7H"Pyrido(l,2,3-DE)-I,4-Benzoxazine-6-Carboxylate

0.8571

2. This issues with the approval of Director (PI).

Directorate General of Foreign Trade,Department of Commerce,(Slui M.V. Singh, FTDO),Udyog Bhawan, New Delhi

(Barnali Kliastgir)Under Secretary to the Government of India

Phone:23071162

F. NO.35011/30/2016-PI -Norms

Government of India


\A7-

11^

Shastri Bhawan,Ne\Ar Delhi, the October 31, 2016

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.1) 2009-14 Case of M/sBliss GVS Pharma Ltd.

The undersigned is directed to refer to DGFT U.O. No. 01/82/050/01849/AM-16/DES-3/37dated the 05/04/2016 vide which application from M/s Bliss GVS Pharma Ltd. was sent to thisDepartment for fixation of norms under para: 4.7 for the export of various Suppositories. Thisdepartment has examined the matter and the following norms are furnished urider para 4.7 of HandBook of Procedures (Vol.1) 2009-14: -

8. No Export Item Qty S.

No.Import Item Quantity allowed

for 1000

Suppositories

1. Recticin-100

Suppositories (eachcontaining Indomethacin100 mg)

1000

Nos.

1. Indomethacin 102 gm

2. lndometacina-100 mgSuppositories (eachcontaining Indomethacin100 mg)

1000

Nos.


3. GMETH Suppositories(each containingIndomethacin 100 mg)

1000

Nos.


4. Indogen-S Suppositories(each containingIndomethacin 100 mg)

1000

Nos.


2) This issues with the approval of competent authority.

(Raj Kumar)Under Secretary to the Government of India

Phone: -23071162

Email: [email protected]

Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi-110011

GOVERNMENT OF INDIAMINISTRY OF SCIENCE & TECHNOLOGYDEPARTMENT OF BIOTECHNOLOGY

M «IRH

Wttifll 3>l sfn

^^-2, 7m Tito ̂ 3ito

^ i^-110003

Block-2,7th Floor, C.G.O. ComplexLodhI Road, New DelhM10003

BT/IL/05/316/2010-PID Date: 05.06.2017

OFFICE MEMORANDUM

Subject: Applications of M/s. Panacea Biotec Ltd., New Delhi, for fixation of I/O Norms forthe export of '62/0-DTwP-HepB-Hib-Pentavalent Vaccine (Easyfive TT)'

The undersigned is directed to refer to the Directorate General of Foreign Tradecommunications vide 1) HQ File Number 01/82/050/01127/AM15/-Dated:05 12 2014* 2) HOFile Number 01/82/050/01019/AM16/-Dated:28.10.2015; 3) HQ File Number01/82/050/00223/AM17/-Dated:28.06.2016 and 4) HQ File Number 01/82/050/00709/AM17/-Dated:29.09.2016 forwarding applications of M/s. Panacea Biotec Ltd., New Delhi, for fixationof I/O Norms for the export of different quantities of '62/0-DTwP-HepB-Hib-PentavalentVaccine (Easyfive TT) (single dose vial of 0.5 ml presentation)' requiring three import inputsnamely i) purified Diptheria Toxoid concentrate antigen bulk, ii) purified Tetanus Toxoidconcentrate antigen bulk and iii) Inactivated whole cell pertussis Bulk. As per the informationfurnished by the applicant, the I/O norms for the above four cases/applications are fixedherewith.

For export of 1 million vials (single dose vial of 0.5 ml presentation) of 'DTwP-HepB-Hib-Pentavalent Vaccine (Easyfive TT)', norm for the imported items are;

1. Purified Diptheria Toxoid concentrate antigen bulk (@ -2050 Lf/ml) = 13.64 Ltr

2. Purified Tetanus Toxoid concentrate antigen bulk (@ -1900 Lf/ml) = 5.23 Ltr3. Inactivated whole cell pertussis bulk (@ -192 OU/ml) = 86.46 Ltr

This issues with the approval of Secretary. Department of Biotechnology.

0^

(Amit Parikh)Scientist 'D'

To,Shri Nirmal Kumar

Deputy DGFTRoom No. 303, Directorate General of Foreign TradeMinistry of Commerce & IndustryUdyog Bhawan, New Delhi-01

Website: http://wvvw.dbtlndia.nlc.in http://www.btlsnet.gov.ln^jWTelephone : 24363012, 243G2329 "^Fax : 011-24362884

(25^ c 4^



Udyog Bhawan,New Delhi, the 21 November, 2013

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1)2009-14 Case of M/s R L Fine Chem Ltd.

The undersigned is directed to refer to DGFT U.O.No.0I/82/50/1370/AM13/DES-3/197 dated the 17/05/13 vide which applicationfrom M/s. R L Fine Chem Ltd was sent to this Department for fixation of normsunder para: 4.7 for the export of Clomipramine Hcl. This department hasexamined the matter and the following norms are furnished under para 4.7 ofHand Book of Procedures (Vol.1) 2009-14:-

S.No. Import Item Qty. Recommended kg/kg..

1. Bormo 3 Chloro Propane 0.85

2. 3 Chloro Iminodibenzyl 0.91

This issues with the approval of Director (Cost).


PI-Norms

Directorate General of Foreign Trade,Department of Commerce,(Shri R.C. Meena, Dy. DGFT),Udyog Bhawan, New Delhi.

XL- /2017-GC and F-DCMSMEO/o THE DEVELOPMENT COMMISSIONER (MSME)

(CHEMICAL DIVISION)7th floor, A Wing, Nirman Bhawan,

■ ̂ New DelhiDate: May, 2017

OFFICE MEMORANDDM

Subiect: Ratification of the norms in respect of advance authorization No0310792363 dated 24.01.20t4, un^er Para 4.7 of HBP obtained by WI/sNational Tube Industries, Wlumbai.

Director General of ForeignlTrade (DGFT) may refer to Its O.M /I.D Note

No. 01/82/050/254/AM16/DES.III/500 ' dated 24.08.2016 fonwardlng AdvanceAuthorization application No. 0310792363 dated 24.01.2014 of M/s National TubeIndustries, Mumbal requesting ratlflcatlori of the norms for the Export of- Slllcone oil 1.0and 2.0 cst. The application was examined and certain clarifications were sought fromM/s National Tube Industries. The application was re-examined In light of theclarifications provided. ^

the quantities of reactants have b^n worked out and may be recommended as

i Export

Product

Exp. Qty.

(Kg)

Import Inputs

(Reactants)

Quantity

Sought (Kg)

Quantity

allowed (Kg)

(I). Silicone Oil1.0 cst

(II) Silicone Oil2.0 cst

9350

4500

Silicone Oil of

0.65 cst 11

11082 9750

BRB CM ̂0 5181.5 5181.5 1t

1j11

rv^aii iivm ^

sought 2629.75 Kg Sulfonated slloxane as catalyst. It Is however observed thattechnically catalyst Is a substance, used | alter the rate of a chemical reaction but Itremain unchanged chemically at th4 fd of the reaction. Also technical literatureIs available which states that Sulfonatkl slloxane used as catalyst In polymerizationof slllcone oil can be reactivated by washing the catalyst with a low molecularweight slloxane medium. It Is lnforme|by M/s National Tube Industries that they areneither reactivating catalyst nor they have any technology and equipments for re-

J"

activation ■ There is no technical literature a«iiable to ascertain or verify the soughtquantity of catalyst. In view of this, norms ccmmittee may decide on the quantity ofSulfonated siloxane to be allowed.

^ This Issues with the approval of comoetent authority.

( H.S Bisht)-;"Director (Chemical)

Shri Nirmal Kumar,Dy. DirectorO/o Director General of Foreign Trade.DES-III Section. Room No. 414M/o Commerce and Industry,Udyog Bhawan,New Delhi

Q UF. No.35011/544/2014-PI (Norms)GoveiTiment of India


Udyog Bhawan,New Delhi, the March, 2015

Office MemorandumSub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol 1)

2009-14 Case of M/s. RL Fine Chem.

The undersigned is directed to refer to DGFT U.O.No.01/82/50/714/AMI5/D"ES-3/721 dated the 21/10/14 vide which an applicationfrom M/s. R L Fine Chem was sent to this Department for fixation of normsunder para: 4.7 for the export of Methane Sulfonate of 10,ll,Dihydro-NNBetatrimethyl 5H Benzo (BP) Azepine-5 Propanamine. This department hasexamined the matter and the following comments are flimished under para 4.7of Hand Book of Procedures (Vol.1) 2009-14:-


1. 1 Bromo 3 Chloro 2 Methyl Propane 0.72

2. Iminodibenzyl 0.74


(Barnali Khastgir)Under Secretary to the Government of India

Phone-23071162Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi

2^

F. NO.35011/1/2016-PI (Norms)Government of India


-3-o

7?

Udyog Bhawan, New Delhi,Dated: 1 June, 2016

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Voi.i) 2009-14 Case of Ws Suven Life Sciences Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/0185/>^M-16/DES-3/1653 dated the lS/2/16 vide which application from M/s Suven LifeSciences Ltd. was sent to this Department for fixation of norms under para: 4.7 forthe export of (1-PhenyImethyl)-1H-lndeno[2,1-b]Pyrldine-6-Carbonitrile. Thisdepartment has examined the matter*

iFGG

DGFT is advised to call following details from .the firm viz:-

1. The import item is catalyst only for which no recovery or regeneration isshown. The firm may be advised to elaborate the recovery of importedcatalyst with technical justification.



PH:-23071162

Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi



Shastri Bhawan, New Delhi.Dated the December 14. 2016

Office Memorandum

Subject: - Application of M/s Porus Laboratories Pvt. Ltd., Hyderabad., for normsagainst export of SIVIKT:{S)-1.{{{1-{3-[2(EH7-Chloro2 quinollnyl)ethenyl)Phenyl1}}-3-[2-(1-hydroxy-1-methyl ethyl) Phenyl]-1-propanol.

The undersigned is directed to refer to DGFT U.O.No. 01/82/050/01755/AM-16/DES-3/1879 dated the 22/03/2016 and recent CM No. 01/82/162/29/AM16/DES-111/105 dated 19/09/2016, seeking comments of the DoP on the response of thecompany. It may be recalled that the DoP conveyed Its views vide this office letter ofeven number dated 1^' June 2016 informing that the product to be exported and itsraw material to be imported are same drug-intermediates for Montelukast and^omanufacturing activity appears to be involved: ^

2) Vide their letter dated 26'^ August 2016, M/s Porus Laboratories Pvt. Ltd.. haveprovided some information without indicating the actual percentage purity of thecrude input to be imported or that of the product to be exported. As such, as alreadyinformed the product to be exported is same as the input to be imported and nomanufact^ring_activitv is to be undertaken. The Norms Committee may like to take aview in the matter as deemed fit.

3) This issues with the approval of competent authority


Phone: 23323292

Email: [email protected] General of Foreign Trade.Department of Commerce.(Shri Nirmal Kumar. Dy DGFT).Udyog Bhawan. New Delhi


F. NO.35011/74/2016-P1 (Norms)Government of India



Office Memorandum

Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.1) 2009-14 Case of M/siVIac Chem Products (india) Pvt. Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1639/AM-16/DES-3/1811dated the 15/3/16 vide which application from M/s Mac Chem Products (india) Pvt. Ltd. was sent tothis Department for fixation of norms under paraj 4.7 for the export of Hydrocortisone SodiumSucclnate Bulk Sterile Lyophilized USP 37. This department has examined the matter and thefollowing norms are furnished under para 4.7 of Fland Book of Procedures (Vol.!) 2009-14:-

S.No. Import item Norms Recommended for

1kg Export

1 Flydrocortisone IP/EP/USP 0.88kg



PH:- 23071162

Directorate General of Foreign Trade.Department of Commerce.(Shri M.V. Singh, FTDO).Udyog Bhawan. New Delhi



Udyog Bhawan, New Delhi,Dated; 26 April, 2016

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.!) 2009-14 Case of M/s Sun Pharmaceutical Industries Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1295/AM-16/DES-3/1237 dated the 15/12/15 vide which application from M/s SunPharmaceutical Industries Ltd. was sent to this Department for fixation of normsunder para: 4.7 for the export of Clarlthromycin Carbomer Granules 43.75%/44%.This department has examined the matter and-

undsLpaEa^533fctisn4Seelu3tErQGfiGlures4VoU)-2009^^

DGFT is advised to call following details from the firm viz:-

1) Copy of valid DML for above export product.2) Copy of Master-Batch formula duly certified by Q.C. incharge.

2. This- issues with the approval of competent authority.


PH:-23071162

Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan. New Delhi

GOVERNMENT OF INDIA

MINISTRY OF SCIENCE & TECHNOLOGY

DEPARTMENT OF BIOTECHNOLOGY

BT/IL/05/316/2010-PID

M<2Kil ̂ 3TIT

vn^ft

6qii«h-2, 7^ ^ "^0

1^^^-110003

Block-2, 7th Floor, C.G.O. ComplexLodhi Road, New.Deihi-110003

^ z-JJ-Date: 05.06.2017

OFFICE MEMORANHIIAA

Subject: Applications of M/s. Panacea Biotec Ltd New Delhi for fiY;^Hnn nf i/n m *the export of ■62/0-DTwP-HepB-Hib-Pentavalent VaccL

The undersigned is directed to refer to the Directorate General of Foreign Tradecommunications vide 1) HQ File Number 01/82/050/01127/AM15/-Dated-05 12 2014* 2) HQFile Number 01/82/050/01019/AM16/-Dated;28.10.2015- 3) HO >ile NiTmherDated-'zP 01/82/050/00709/AM17/-nf i /n M J fowarding applications of M/s. Panacea Biotec Ltd., New Delhi, for fixationof I/O Norms for the export of different quantities of '62/0-DTwP-HepB-Hib-PentavalentVaccine (Easyfive TT) (single dose vial of 0.5 ml presentation)' requiring three import inputsnamely i) punfied Dipthena Toxoid concentrate antigen bulk, i1) purified Tetanus ToxoidfurnNh d B 'T'" Bulk As per the informarionSth ' ''' '' cases/applications are fixedHih PentX.1»ni V ^ Vials (single dose vial of 0.5 ml presentation) of 'DTwP-HepB-Hib-Pentavalent Vaccine (Easyfive TT)', norm for the imported items are;

1. Purified Diptheria Toxoid concentrate antigen bulk (@ -2050 Lf/ml) = 13.64 Ltr2. Purified Tetanus Toxoid concentrate antigen bulk (@ -1900 Lf/ml) = 5 23 Ltr3. Inactivated whole cell pertussis bulk (@ -192 OU/ml) = 86 46 Ltr

This issues with the approval of Secretary, Department of Biotechnology.

Q>h


To,Shri Nfrmal KumarDeputyDGFTRoom No. 303, Directorate General of Foreign TradeMinistry of Commerce & IndustryUdyog Bhawan, New Delhi-01

Website : http://www.dbtindia,nic.in http://www.btlsnet.gov.ln^:Wrelephone : 24363012, 243G2329 ̂ ^Fax : 011-24362884

1-c?

no




Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of iVI/s Shasun Pharmaceuticals Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1253/AM-16/DES-3/1472 dated the 12/1/16 vide which application from M/s ShasunPharmaceuticals Ltd. was sent to this Department for fixation of norms under para:4.7 for the export of Gabapentin Tablets USP 800mg. This department has

Rnnk nf PrnnpHi itpq [\/n\ I) 9nnn -| mtSlicJ ui idei pdia 4 7 uf HaDGFT is advised to call copy of Master-Batch formula from the firm.



PH:-23071162


F. No.35011/837/2015-Pl (Norms)Government of India


Udyog Bhawan, New Delhi,Dated: 18 May, 2016

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s MSN Labs Pvt. Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1357/AM-16/DES-3/1507 dated the 12/1/16 vide which application from M/s MSN Labs Pvt.Ltd. was sent to this Department for fixation of norms under para: 4.7 for the exportof Epierenone. This department has examined the matter.afld-tbeToHevvfng-fiofms

'-ufldor para 4.7-Qf44and-Eook of ProGedwe&-(VeU)-2e99-44^


1. Copy of technical literature in support of the yields claimed by the firm atvarious stages.

2. Past production vis-a-vis actual consumption of imported input duly certifiedby Central Excise Authorities.



PH:-23071162

Directorate General of Foreign Trade,.Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi

9?



Udyog Bhawan, New Delhi,Dated: 26 April, 2016

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s Sun Pharmaceutical Industries Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1295/AM-16/DES-3/1237 dated the 15/12/15 vide which application from M/s SunPharmaceutical Industries Ltd. was sent to this Department for fixation of normsunder para: 4.7 for the export of Clarithromycin Carbomer Granules 43.75%/44%.This department has examined the matter and'tho following nofffls--ai:e-fum4sbed


1) Copy of valid DML for aboye export product.2) Copy of Master-Batch formula duly certified by Q.C. incharge.



PH:-23071162





Office Memorandum

Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.1) 2009-14 Case of WI/s Sun Pharmaceutical Industries Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1438/AI\/l-16/DES-3/1407 dated the 11/1/16 vide which application from M/s SunPharmaceutical Industries Ltd. was sent to this Department for fixation of normsunder para: 4.7 for the export of Clarithromycin Carbomer Granules 27.5/28%.This department has examined the matter, gnd the fo!k>wlng-4:tom^s--afe-4umishedunder para 4.7 QLHaiid-BQol^^f-Pfe6e4ures (Vnl l) 2009-14:-


1) Copy of valid DML for above export product.2) Copy of Master-Batch formula duly certified by Q.C. incharge.



PH:-23071162

Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO).Udyog Bhawan, New Delhi

Cji)



Shastri Bhawan, New Delhi.Dated; February 16, 2017

Office Memorandum

Sub: - Fixation of norms under para 4.7- Application of M/s Jodae-gxpeim (P) Ltd, forexport of Novatrizoate 76% (Diatrizoate Meglumine and DiatrizoateSodium Injection 600 mg i/ml and 760 mg/I ml)..

The undersigned is directed to refer to DGFT U.O. No. 01/82/050/00068/AM-17/DES-3/120 dated 23/05/2016 and subsequent letter from M/s Jodas Expoim Pvt.Ltd., for fixation of norms against export of Novatrizoate 76% (DiatrizoateWieglumine and Diatrizoate Sodium Injection 600 mg l/ml and 760 mg/I ml).This department has examined the matter and following observation are made.

2. The application is incomplete and adequate details including DML, needed forworking out requirement of raw materials are not available.

3) In view of the above, the DGFT may direct the applicant to provide:(i) Application form prescribed for norms under para 4.7 of Handbook of Procedures.(ii) A copy of valid Drug Manufacturing License for the export products.(iii) The quantity of each type of vials to be exported.(iv) Method of calculation used to arrive at the quantity of Diatrizoic Acid for export ofeach vial of injections with different strengths.


Phone:23323292

Email: barn.khast(S)nic.inDirectorate General of Foreign Trade,Department of Commerce,(Shri Nirmal Kumar, Dy DGFT),Udyog Bhawan, New Delhi


[o 0

2^



Udyog Bhawan, New Delhi.Dated: 18 May, 2016

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.I) 2009-14 Case of IVI/s Kopran Research Labs Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1597/AM-16/DES-3/1743 dated the 2/3/16 vide which application from M/s Kopran ResearchLabs Ltd. was sent to this Department for fixation of norms under para: 4.7 for theexport of Doripenem Sterile. This department has examined the matter and thefollowingjiiKiiis-afeTtmrshHdTmdef-^afa-4;?-oTHand-Bool^L^eedur-e^^ I)


1. Complete technical detail as per appendix-33 showing chemical reactions, %yield on molar basis etc.

2. Copy of technical literature in support of yields envisaged.3. Past production vis-a-vis actual consumption of imported inputs duly certified

by Central Excise Authorities.

This issues with the approval of competent authority.

(Rajkumar)- Under Secretary to the Government of India

PH:-23071162


(?(

1 0^

Case No.:37/15/82-

ALC4/20I3

HQ File

:01/82/050/00799/AMI4/

Party Name;AMINES &

PLASTICIZERS LIMITEDMeet No/Date: 18/82-

ALC4/2013

I9.I2.20I3

Lic.No/Date:03107495I613.09.2013

Status:Case

Approved

Defer Date:RLA File

- :03/94/040/00510/AM14/Decision :ln the light of written comments received from Department of Chemicais and.Petrochemicals vide their U.O No. 14010/61/2011-Ch 11 dated 02.12.2013, it was decided to

249 ratify norms under Para 4.7 of HBP vl as per details given below or as applied by the firm,whichever is less:

Export product Exp.

Qty.

SI.No. Import items Qty. allowed

N-

FormylMORPHOLINEIkg 1.

MORPHOLINE0.810 kg

KA may take appropriate action as per the decisloh of Norms Committee.

[0



rfr

106


Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of WI/s Fresenius Kabi Oncology Ltd.

The undersigned is directed to refer to DGFT U.Q.No. 01/82/50/1681/AM-16/DES-3/1829 dated the 15/3/16 vide which application from M/s Fresenius KabiOncology Ltd. was sent to this Department for fixation of norms under para: 4.7 forthe export of Innotecan Hcl injections 500mg, SOOmg, lOOmg, 40mg. Thisdepartment has examined the matter and the following norms are furnished underpara 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-


1) Complete technical details as per appendix-33 for the manufacture ofirinotecan Hcl 3H2O (API) showing moi.\Art., % yield on molar basis for eachstep.

2) Consumption-coefficient of R.M. for 1kg API.3) % wastage claimed on API in the manufacture of injections of different

strength/vial size.


(Rajkumar)Under Secretary to the Government Of India

PH:-23071162


2^O



Udyog Bhawan, New Delhi,Dated; 1 June, 2016

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14 Case of WI/s Morepen Labs Ltd.

■!? 01/82/50/1689/AM-lb/UbS-3/1815 dated the 15/3/16 vide which application from M/s Moreoen LabsL d^was sent to this Department for fixation of norms under para 4 7 for threxportdepartment has examined the matternorms are furn^sbed-ufldeH3ara-4JZ^f Hand Ropt^ef Proceduicc (Voi-|)-2009-44^


1. Description of import item SXS01 does not match with its chemicalconfiguration shown in step-1 reaction. Correct import description or itsstructure used in chemical reaction may be given alongwith revisedchemistry.2. Past production vis-a-vis actual consumption of all import inpurts dulycertified by central excise authorities may be furnished.



PH:-23071162




o-

Udyog Bhawan. New Delhi,Dated: August. 2016

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14 Case of M/s Optimus Drugs (P) Ltd.

°GFT U.O.No. 01/82/50/253/AM-

, L dated the 4/7/16 vide which application from M/s Optimus Drugs (P)Ltd. was sent to this Department for fixation of norms under para: 4 7 for the exportof Srmeprevir. This department has examined the matter

a/:eJumished-tmderpaFa-4:7j2fJiand-Boo)v0FfT-eGedmBs-{VGy)-2OO9-44^


1) Description of import item does not match with the description given in theprocess detail /chemistry.The correct description of import item may be given.

2) Past production vis-a-vis actual consumption of import inputs duly Certifiedby Central Excise Authorities may be furnished.



PH:-23071162

Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO).Udyog Bhawan, New Delhi.



Udyog Bhawan, New Delhi,Dated: August. 2016

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol I) 2009-14 Case of Mis Zim Labs Ltd. '

^-Q-No- 01/82/50/183G/AM-16/DES-3/20 dated the 4/4/16 vide which application from M/s Zim Labs Ltd wassent to this Department for fixation of norms under para: 4.7 for the export of

'^®P3'^^ent has examined

Ploceduffis4Vey)-20e9-t4:- ef^ara . eok of


Both the Export description as well as net content of prednisolone BP in each of thetwo export products do not match with the DML furnished by the firm.Technical justification alongwith revised details may be furnished by the firm.



PH:-23071162

Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO).Udyog Bhawan, New Delhi.

j oC



Shaslri Bhawan, New Delhi,Dated: September 2017

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures fVoI I) 2015 -90Case of M/s. Covalent Laboratories Pvt. Ltd.

3/361 dltedSTSfSbtr'VV'^®'' 0I/82/50/1789/AM-I6/DES-Ammo 3-VinyI-3-Cephem-4-CarbozyIic Acid fV-AVCA^ Thic + i

o7pTo::zt

S. No. Import ItemNorms Recommended for 1kg

Export

I.

7-PhenyIacetamideo-3-ChloroniethylCephalosporonic Acid Para Methoxybenzyl Ester(GCLE)

2.672kg2. Acetone

2.1375kgj>. Methylene Chloride

10.26kg4. Methanol

7.87kg5. Activated Carbon

0.1kg

2.) This issues with the approval of competent aiJthority.

,P(Parveen Kumar)Under Secretaiy to the Government of India

E-mail: parveen. [email protected]:-23352298

Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi),Udyog Bhawan, New Delhi.

E-mail: [email protected]

Ph: 23061562, Extn.269



Udyog Bhawan. New Delhi,Dated; September. 2016

Office MemoranHiim

Subject: - Fixation of norms under para-4.7 of Hand Book of.Procedures (Vol.!) 2009-14 Case of IW/s Strides Shasun Ltd.

.on.A undersigned is directed to refer to DGFT U O No 01/82/50/1fi2 R,whiSrfplicatr^^^^^^^fnr 'his Department for fixation of norms under para- 4 7

DGFT IS advised to call copy of master-batch formula from the firm dulyauthenticated by their Q.C. incharge.



PFl:-23071162

Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi.

or



Udyog Bhawan, New Delhi, )Dated: August, 2016

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of WI/s Fresenius Kabi Oncology Ltd.

■ 17/DES^W8TS"fh 01/82/50/250/AM-application from M/s Fresenius KabiOncology Ltd_was sent to this Department for fixation of norms under para- 4 7 for

This department has examined the

DGFT is advised to call following information/detail from the firm viz:-

1) Copy of Master-Batch formula duly certified by Q.C. Incharge.2) Consumption-coefficient of raw material for paclitaxel API3) Wastage claimed on API for the above export.



PH:-23071162

Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh,.FTDO),Udyog Bhawan, New Delhi.

F.NO.35011/241/2016-PI (Norms)Government of IndiaMinistry of Chemical & Fertilizers

Department of Pharmaceuticals

Office IVremoranriiim

Shastri Bhawan, New Delhi,Dated; September l^Jt, 2017

Caseof M/s.™ien'^^^^^^ of Procedures (VoM) 2015-20

3/361 dated the 17/08/2^16 0I/82/50/1789/AM-16/DES-Ltd. was sent to this Department f^ifxa L oTn^" Laboratories Pvt.Am.no-3.VinyI-3-Cephem-4-CarbozSirrcid (7 rVCAf 4.7 for the export of 7-

S. No.Import Item

7^hM^d^^ii;^,ideo-3-ChIoro"S;S^Cephalosporonic Acid Para Methoxybenzyl Ester,GCLE)

Norms Recommended for 1 kgExport

2.672kg2. Acetone

2.1375kgMethylene Chloride

4. Methanol

5. Activated Carbon

10.26kg

7.87kg

0.1kg

2.) This issues with the approval of competent authority.

(Parveen'i&mar)Under Secretary to the Government of India

E-mail; parveen. [email protected]:-23352298

Directorate General" of Foreign Trade,Depaitment of Commerce,(Shri S.K. Panigrahi),Udyog Bhawan, New Delhi.

E-mail: [email protected]: 23061562, Extn.269

u o

1^^F. NO.35011/281/2016-PI (Norms)Government of India


Janpath Bhawan, New Delhi.Dated; September 15. 2017

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2015-20 Case of M/s Sentiss Pharma Pvt. Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/365 &616/AM-17/DES-3/427 & 509 dated the 19/08/2016 & 31/08/2016 vide whichapplication from M/s Sentiss Pharma Pvt. Ltd. was sent to this Department forhxation of norms under para: 4.7 for the export of Oftahist (Olopatadine EyeSolution 0.1% vial, of 5ml). This department has examined the matter and the

oniTon. Psra 4.7 of Hand Book of Procedures (Vol.i)

S.No. Import Item Norms Recommended1 Olopatadine FIcI 5.65mg for one eye/ear

drop of 5ml


(Parveen Kumar)Under Secretary to the Government of India

Phone:23352298

_ Email: [email protected] General of Foreign Trade.Department of Commerce,(Shri S.K. Panigrahi. Economic Officer. DES-lllPhone No: 23061562. (269),Udyog Bhawan, New Delhi


\u



Udyog Bhawan, New Delhi,Dated: July, 2016

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s Orbit Life Sciences (P) Ltd.

The undersigned is directed to refer to DGFT U.O.No. O'l/82/50/308/AM-17/DES-3/218 dated the 6/7/16 vide which application from M/s Orbit Life Sciences(P) Ltd. was sent to this Department for fixation of norms under para: 4.7 for theexport of imipenem (Sterile I Technical / N-FormimidoyI I Thienamycin Hci). Thisdepartment has examined the matter and the following norms are furnished underpara 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-

DGFT is advised to call following details/clarification from the firm viz:-

1) Whether the export item is sterile or technical grade.2) If sterile, please give details of conversion from tech. grade to sterile

alongwith yield etc.3) The DML furnished by the firm is only for export/manufacture imipenem (Non-

Sterile). How the firm will be manufacturing/exporting Sterile product.4) The import items at appendix-11A do not tally with ANF-4A.The correct and

revised list of import items may be furnished as many inputs have beenshown indigenous in appendix-11A



PH:- 23071162


II 7^


Ministry of Chemical & Fertilizers


Room No. 302, 3'^ Floor,Janpath Bhawan New Delhi,Dated: September 12, 2017

Office MemorandumSubject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-

14 Case of IW/s Softgel Healthcare (P) Ltd.

The undersignedus directed to refer to DGFT U.O. No. 01/82/050/00542/AM-17/DES-lli/566 dated the 07/10/2016 vide which application from M/s SoftgelHealthcare (P) Ltd. was sent to this Department for fixation of norms for the export ofSoft Gelatin Capsules Fish Oil 1000 mg (Omega-3 Capsules 1000 mg) Thisdepartment has examined the matter and the following norms are furnished againstthe export item:

Product to be Exported Raw materials to be importedDescription Quantity Description Quantity in gm

Soft Gelatin Capsules AspacardioQ10 - 30 mg (each capsules containco-enzyme Q10-30 mg).

1000 Nos. Ubidecarenone (Co-enzyme Q10)

30.60 gm

Soft Gelatin Capsules AspacardioMix Omega 3 + Q10-100 mg (eachcapsule contain co-enzyme QIC 100mg besides omeqa

1000 Nos. Ubidecarenone (Co-enzyme Q10)

102 gms



Phone; 23352298

Email: [email protected] General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi, Economic Officer, DES-IIIPhone No: 23061562, (269),Udyog Bhawan, New Delhi


V3'



Shastri Bhawan.New Delhi,Dated the April 3, 2017

Office Memorandum

Subject: - Application from M/s J.B. Chemicals & Pharmaceuticals Ltd. for norms ofAmylmetacresol Antiseptic Throat Lozenges Sugar Free Blackcurrantand Other Flavor and Amylmetacresol Antiseptic Throat LozengesLemon/Cherry and Other Flavor.

The undersigned is directed to refer to DGFT U.O.No. 01/82/050/00582/AM-17/DES-3/520 dated the 05/09/2016 vide which application from M/s. J.B. Chemicals& Pharmaceuticals Ltd was sent to this Department for fixation of norms under para:4.7 for the export of Amylmetacresol Antiseptic Throat Lozenges Sugar FreeBlackcurrant and Other Flavor and Amylmetacresol Antiseptic Throat LozengesLemon/Cherry and Other Flavor. Besides API the applicant also intends to importexcipients for which Master Batch Formula duly certified by the Quality Control In-Charge of the company is needed and the same is not provided with application.

2) In view of the above, the applicant may be advised to provide copy of Master BatchFormula duly certified by the Quality Control In-Charge of the company so that therequirement of excipients may be worked out.

Barnali Khastgir)Under Secretary to the Government of India

Phone: 23323292


Directorate General of Foreign Trade,Department of Commerce,

-(Shri Nirmal Kumar, Dy DGFT),Udyog Bhawan, New Delhi




0

Shastri Bhawan.New Delhi,Dated the August 24. 2017

Office Memorandum

Subject: - Application from M/s J.B. Chemicals & Pharmaceuticals Ltd. for norms ofOxybutynin Chloride Extended Release Tablets 10 mg .

The undersigned is directed to/efer to DGFT U.O.No. 01/82/050/00586/AM-17/DES-3/536 dated the 05/09/2016 vide which application from M/s. J.B. Chemicals& Pharmaceuticals Ltd was sent to this Department for fixation of norms under para'4.7 for the export of Oxybutynin Chloride Extended Release Tablets 10 mg. Theapplication of the unit has been examined and following quantities are recommendedfor one tablet of lOmg Oxybutynin chloride Extended Release.

S. No. import Item Qty. Recommended1. Oxybutynin chloride USP 10.02mq/tablet2. Sentry Polyox WSR N80 FP NF 80.77mq/tablet3. Sentry Polyox WSR 303 NF 41.10mq/tablet

2. This issue is with the approval of Competent Authority.


Phone: 23352298


Directorate General of Foreign Trade,Department of Commerce,(Shri Panigrahi, Dy DGFT),Room No. 414, Udyog Bhawan, New Delhi

A, VIt y

159F. N0.35OII/379/2OI6-PI (Norms)

Government of India


Room No. 302, 3'^'^ Floor.Janpath Bhawan New Delhi,Dated; September^, 2017

Office Memorandum ' v

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14Case of Wl/s J.B. Chemicals & Pharmaceuticals Ltd.

The undersigned is directed to refer to DGFT U.O. No. 01/82/050/0G660/AM-17/DES-11I/552 dated the 03/10/2016 vide which application from M/s J.B. Chemicals &Pharmaceuticals Ltd. was sent to this Department for fixation of norms for the export ofvarious medicated throat lozenges containing Benzocaine as one of the API. Thisdepartment has examined the matter and the following norms are furnished against theexport item:

Product to be Exported Raw materials to be imported

Description Quantity Description Quantity in gm

Benzocaine and Cetylpyridinium ChlorideAnesthetic Throat Lozenges Flavours

Black Current, Honey Lemon & OtherFlavours (Each lozenge containsBenzocaine 12 mg)

1000

lozenges

Benzocaine 12.240 gm

Benzocaine and Cetylpyridinium ChlorideAnesthetic Throat Lozenges Flavours lime

and lemon and Other Flavours (Each

lozenge contains Benzocaine 10 mg)

1000

lozenges

Benzocaine 10.20 gm

Benzocaine, Cetylpyridinium Chloride andDextromethorphan HydrobromideAnesthetic Throat Lozenges (Each lozenge

contains Benzocaine 1.25 mg)

1000

lozenges

Benzocaine 1.275 gm



Phone: 23352298


Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi, Economic Officer, DES-lllPhone No: 23061562, (269), Udyog Bhawan, New DelhiEmail: sl<[email protected]

F. NO.35011/348/2016-PI -Norms

Government of India


Office Memorandum

Shastri Bhawan,New Delhi, April 3, 2017

Subject: - Application from M/s Cadila Healthcare Ltd. for norms of FludarabinePhosphate Injection 50 mg/2ml.

The undersigned is directed to refer to DGFT U.O. No. 01/82/050/00601/AM-17/DES-3/551 dated the 06/09/2016 vide . which application from M/s CadilaHealthcare Ltd. was sent to this Department for fixation of norms under para: 4.7 forthe export of Fludarabine Phosphate Injection 50 mg/2ml. This department hasexamined the matter and the following norms are furnished:

Name of ExportProduct

Quantity 8.

No

Inputs recommended Quantity for 100vials

Fludarabine

Phosphate injection 50mg/2mi (each mlcontains Fludarabine

Phosphate 25 mg)

100 vials 1. Fludarabine Phosphate 5.500 gm

2. Glass Vial M Clear 20-mm

T-1, 6 ml CA7844 Glassvial 6 ml capacity

As per packingPolicy

3. Rubber Stoppers GreyBromobutyle


Directorate General of Foreign Trade,Department of Corhmerce,(Shri Nirmal Kumar. Dy DGFT),Udyog Bhawan, New Delhi


Barnali Khastgir)Under Secretary to the Government of India

Phone: 23323292


//?

F. No. 35011/315/2016-PI (Norms)Government of India


Shastri Bhawan. New Delhi,Dated; September 5, 2017

Office Memorandum

Sub. - Fixation of norms under para 4.7 of Hand Book of Procedrues (Vol.1) 2009-14, Case of M/s Reanon Pharmaceuticals.

The undersigned is directed to refer to DGFT U.O. No. 01/82/50/553/AM-17/DES-3/510 dated the 31/08/2016 vide which application from M/s ReanonPharmaceuticals. Was sent to this department for fixation of norms under para: 4.7for the export of Renongin injection. This department has examined the matter thefollowing norms are furnished under para 4.7 of Hand Book of Procedures (Vol 1)2009-14:- . ^ ^

S. No. Import Product Norms Recommended1 Potassium Aspartate 474.6mg per vial of 10ml of Renongin

Iniection

2. This issue is with the approval of competent authority.


Phone: 23.352298Email: [email protected]

Directorate General of Foreign Trade,(Shri S.K. Panigrahi, Dy DGFT),Room No.414, Udyog Bhawan,New Delhi-110001



(bZG3

-2^

Shastri Bhawan, New Delhi,Dated: august 31, 2017

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14 Case of M/s Styrax Pharma Pvt Ltd.

The undersigned is directed to refer to DGFT U.O.Nor 01/82/50/635/AM-17/DES-3/556 dated the 26/09/2016 vide which application from M/s. Styrax PharmaPvt Ltd. was sent to this Department for fixation of norms under para: 4.7 for theexport of 2,4DiFluoro-Alpha-(1-H1,2,4 Triazole 1-1y!) Acetophenone (D.F.T.A).This department has examined the matter and .the following norms are furnishedunder para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-

S. No. Import Item Qty. Recommended kg/kg.

1. 1,3 Di Fluorobenzene' 0.60

2. 4 Amino Triazole 0.47

3. Methlene Di Chloride 1.41

4. Acetonitrile 1.65



Phone: 011-23352298

Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panlgrahi),Udyog Bhawan, New DelhiPh: 011-23061562, Extn.269

1/7

o

F.NO.35011/374/2016-P1 (Norms)Government of India


Office Memorandum

Shastrl Bhawan, New Delhi,Dated; Septembers, 2017

Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol I) 2009-14Application of M/s Cadila Healthcare Ltd.

The undersigned is directed to refer to DGFT U.O. No. 01/82/50/639/AM-17/DES-3/549 dated, the 03/10/2016 vide which an application from M/s CadilaHealthcare Ltd. was forwarded to this Department for fixation of norms for theexport of Clopidogrei Besylate. This department has examined the matter and thefollowing norms are recommended against this application:-

S.No. Import Product Norms Recommended1 4,5,6,7-Tetrahydrothieno[3,2-C] Pyridine

Hcl0.626kg

2 L(-) Camphor Sulphonic Acid 0.6I3kgj Dichloromethane 1.348kg4 Acetone 4.932kg

5 Methanol 1.435kg



E-mail: parveen.19(§gov.inPh:-23352298


E-mail: sl<.panigrahi(@nic.in

Ph: 23061562, Extn.269




Room No. 302, 3^^ Floor,Janpath Bhawan New Delhi,Dated: September 6, 2017

Office Memorandum

\

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of Wl/s Encube Ethicals Pvt. Ltd.

The undersigned is directed to refer to DGFT U.O. No. 01/82/050/0055"6/AM-17/DES-III/528 dated the 05/09/2016 vide which application from M/s EncubeEthicals Pvt. Ltd. was sent to this Department for fixation of norms for the export ofNystatin & Triamclnolone Acetonide Cream In 15 gm, 30gm and 60 gm tubes.This department has examined the matter and the following norms are furnishedagainst the export item:

S.No Raw Materials Quantity allowed for 1000 tubes

15 gm tube 30 qm tube 60 gm tube1. Nystatin 1.53 BOU 3.06 BOU 6.12 BOU2. Thamcinolone Acetonide 15.30 gm 30.60 gm 61.20 gm3. Dried Aluminum Hydroxide

Gel/Powder

37.534 gm 75.068 gm 150.136 gm

4. Mono & Diglycerides NF 1949.220 gm 3898.44 gm 7796.88 qm5. Polyethylene Giycol 400

Monostearate-IH

224.910 gm 449.82 gm 899.64 gm

6. Simethicone emulsion 14.994 gm 29.988 gm 59.976 gm7. Petrolatum Jelly Yellow/White

bearing Brand/Tradename SuperWhite Protopet (R)

2249.100 gm 4498.2 gm 8996.4 gm

8. Polyoxyl 20 cetostearyl ether NF 999.847 gm 1999.694 gm 3999.388 gm9. Noncrystallizing Sorbitol Solution

NF

999.847 gm 1999.694 gm 3999.388 gm

10. Polysorbate 60 NF 299.880 gm 599.76 gm 1199.52 gm11. Nystatin and Thamcinolone one

Acetonide Cream

As per packing policy



Phone: 23352298


Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi, Economic Officer, DES-HIPhone No: 23061562, (269), Udyog Bhawan, New Delhi

a-



Shastri Bhawan, New Delhi,Dated: September 5, 2017

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1)2009-14 Case of M/s BDR Pharmaceuticals Pvt. Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/695/AM-17/DES-3/594 dated the 31/10/2016 vide which application from M/s BDRPharmaceuticals Pvt. Ltd. was sent to this Department for fixation of normsunder para: 4.7 for the export of Aprepltant Capsules 125mg/80mg. Thisdepartment has examined the matter and the following norms are furnishedunder para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-

Export Product Qty. Import Items Qty. in Kg.Pack of one capsule 125mg+ Two capsules of SOmgAprepitant

One pack Aprepitant 290.7mg



B-mail: [email protected]:-23352298



Ph: 23061562, Extn.269


Ministry of Chemicai & FertilizersDepartment of Pharmaceuticals

Shastri Bhawan, New Delhi,Dated; September 1, 2017

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of WI/s Vivimed Labs (Alathur) Pvt. Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/654/AM-17/DES-3/554 dated the 26/09/2016 vide which application from M/s Vivimed Labs(Alathur) Pvt. Ltd. Ltd. was sent to this Department for fixation of norms under para:4.7 for the export of Losartan Pottasium Tablets DSP 25mg, 50mg, 100mg. Thisdepartment has examined the matter and the following norms are furnished underpara 4.7 of Hand Book of Procedures (Vol.l) 2009-14:-

S.No. Import item Norms Recommended for 1

Tablet

25mgTablet

50mgTablet

100mgTablet

1 Losartan Pottasium USP 25.5mg 51mg 102mg

2 Mannitol (Pearitol 160C) 101.9mg 203.8mg 407.6mg

3 Microcrystalline Cellulose (Avicel PH 102) 40.5mg 81.0mg 162mg

4 Crosscarmellose Sodium (Ac Di Sol) 7.19mg 14.38mg 28.76mg

5 Povidone K 29/32 3.61mg 7.22mg 14.44mg

6 Magnesium Sterate (Mallickrondt 2257) 1.8mg 3.6mg 7.2mg

7 Opadry white (03H28419) 3.6mg 7.2mg 14.4mg



E-mail: [email protected]:-23352298

Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi),Udyog Bhawan. New Delhi.E-mail: [email protected]

Ph: 23061562, Extn.269

0.3^

F.N0.35OII/374/2OI6-PI (Norms)Government of India


Office Memorandum

Shastri Bhawan, New Delhi,Dated: Septembers, 2017

Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14,Application of M/s Cadila Healthcare Ltd.

The undersigned is directed to refer to DGFT U.O. No. 01/82/50/639/AM-17/DES-3/549 dated the 03/10/2016 vide which an application from M/s CadilaHealthcare Ltd. was forwarded to this Department for fixation of norms for theexport of Clopidogrei Besylate. This department has examined the matter and-thefollowing norms are recommended against this application:-

S.No. Import Product Norms Recommended

I 4,5,6,7-Tetrahydrothieno[3,2-C] PyridineHcl

0.626kg

2 L(-) Camphor Sulphonic Acid 0.613kg3 Dichloromethane 1.348kg4 Acetone 4.932kg5 Methanol 1.435kg


(Parveen Kumar)Under Secretaiy to the Government of India

E-mail: parveen. 19(@gov.inPh:-23352298


E-mai 1: sk.panigrahi(§nic.in

Ph: 23061562, Extn.269

F. No.350n/420/2016-PI (Norms)Government of India


CP

"V

Shastri Bhawan, New DelhiDated: the September 11. 2017

Office Memorandum

Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-20 Caseof M/s Sun Pharmaceuticals Industries Ltd.

The undersigned is directed to refer to DOFT U.O_.No. 01/82/50/780/AM-17/DES-3/634 dated the 30/04/2016 vide which an application from M/s Sun PharmaceuticalsIndustries Ltd. was sent to this Department for fixation of norms under para: 4.7 for theexport of Clarithromycin Carbomer Granules 27.5% / 27.75% / 28%. This departmenthas examined the matter and the following comments are furnished under para 4.7 of HandBook of Procedures (Vol.l) 2015-20:-


1.Carbopol 974P' 0.20

2.

Claritliromycin OR Its raw materials as per

SIGN A-2263 on pro-rata basis. 0.2777



E-mail: parveen. [email protected]:23352298



Ph: 23061562. Extn.269

;0 /82/050/00877/AM15/ :03/95/040/00292/AM15/ 110.07.2014

vision : In the light of earlier decision taken in meeting no. 8/82 dated 25.09.2014, itdecided to ratify norms under Para 4.7 of HBP vl as per details given below or as

)Iied by the firm, whichever is less;

)rt product

temether

Exp.Qty.

1Kg

SI.No.

1.

import items

Artemlsinin

Qty, allowed

may take appropriate action as per the decision of Norms Committee1.235 kg

0 se No.:26/9/82-ALC4/2014

296 fFile0 /82/050/00823/AM15/

Parly Name:ALMELO PVTLTD

RLA File

:09/24/040/00188/AM15/

Meet No/Date: 11/82-ALC4/20I4

26.11.2014


11.07.2014

$tatiis:I>efreredand Re-lndezed

Defer

Date:22.12J014

ision:: It was decided to defer the case for 22.12.2014 for comments ofDepartmentPharmaceuticals

i No.:65/9/82-ALC4/2^4

I File

1/82/050/00862/AMI5/

Party Name: AMINES &plasticizers limited

RLA

Fi!e:03/94/040/00298/AM15/

297

Meet No/Date: 11/82-

ALC4/2014

26.11.2014

Lic.No/Date:031078681314.07.2014

Status:

Approved

Defer Date:

cision : in the light of written comments received from Department of Chemicals and Petrochemicalsvi le their U.O No. 14Q10/61/2013/Ch II dated 11.11.2014, it was decided to ratify norms under Para 4.7HBP vl as per details given below or as applied by the firm, whichever Is less:

Export Product

l-PIPERIDINOETHANOL "

Export

Quantity

licg

S.NO

2.

Import Product

PIPERIDINE

R , may take appropriate action as per the decision of Norms Corhmittee

Quantity

Allowed

0.694 kg

2S6

C ise No.:88/9/82-ALC4/2014

298 fiQFile

1/82/050/00885/AM15/

Party NamerMAC CHEMPRODUCTS (INDIA)PRIVATE LIMITED

RLA File

:03/95/040/0{)302/AM15/


ALC4/2014

26.11.2014

Lic.NQ/Date:0310786782

14.07.2014

Statiis:Deflered

and fo-lndexed

Defer

Date:22.12.2014

ecision : It was decided to defer the case for 22.12.2014 for comments ofDepartmentPharmaceuticals.

29S

(Qase No.: 108/9/82-4/2014

!Q Filell/82/050/00905/AM15/

Party Name:NECTARLIFESCIENCES LIMITED,

RLA File

:22/24/040/00083/AM14/


ALC4/2014

26.11.2014

Ljc.No/Date:22I0015019

15.07.2014

StatusiDeffered

and Re-Indexed

Defer

Date:22.1220]4

^ecision: It was decided to defer the case for 22.12.2014 for comments ofDepartment'Phaimaceuticals.

udyog

1 2--^




Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!)2009-14 Case of M/s J.B. Chemicals & Pharmaceuticals Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/697/AM-17/DES-3/587 dated the 31/10/2016 vide which application from M/s. J.B.Chemicals & Pharmaceuticals Ltd was sent to this Department for fixation ofnorms under para: 4.7 for the export of IVY Syrup 100ml bottle. Thisdepartment has examined the matter and the following nonns are furnishedunder para 4.7 of Hand Book of Procedures (Vol.1) 2015-20:-

S.No. Import Item Qty.I IVY Leaf Powder Extract 0.714gms per 100ml

bottle


(Parveen Kumar)Under Secretaiy to the Government of India

E-mail: [email protected]:-23352298



Ph: 23061562, Extn.269

-2r§3-

F. 'No.35011/395/2016-PI (Norms)Government of India

Ministry of Chemicai & Fertiiizers


Room No, 302, 3'" Floor,Janpath Bhawan New Delhi,

Dated; September/, 2017

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s J.B. Chemicals & Pharmaceuticals Ltd.

The undersigned is directed to refer to DGFT U.O. No. 01/82/050/00696/AM-

17/DES-III/586 dated the 31/10/2016 vide which application from M/s J.B. Chemicals& Pharmaceuticals Ltd. was sent to this Department for fixation of norms for the

export of Medicated lozenges containing Cetylpyridinium Chloride,Benzydamine Hydrochloride and Phoicodine as APIs. This department hasexamined the matter and the following norms are furnished against the export item:


Description Quantity Description Quantity ingm

Cetylpyridinium Chloride, BenzydamineHydrochloride and Phoicodine lozengesSugar free, Black currant and otherflavours (each lozenge contain 5.50 mgPhoicodine, Benzydamine Hydrochloride 1.50mg and Cetylpyridinium Chloride 1.33 mg)

1000

lozengesPhoicodine 5.61 gm

Benzydamine 1.53 gm

CetylpyridiniumChloride

1.3566 gm

Isomalt ST-M 2466 gm

Phoicodine and Cetylpyridinium Chloride,lozenges sugar free orange/lemon andother flavours (each lozenge contain 5.50mg Phoicodine, and Cetylpyridinium Chloride1.33 mg)

1000

lozengesPhoicodine 5.61 gm

CetylpyridiniumChloride

1.3566 gm

Isomalt ST-M 2466 gm



Phone: 23352298


Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi, Economic Officer, DES-IIIPhone No: 23061562, (269),Udyog Bhawan, New Delhi


"Vuo

F. NO.35011/416/2016-PI (Norms)

Government of India



Room No, 302, 3'" Floor,Janpath Bhawan New Delhi,

Dated: September 15, 2017

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!)' 2009-14 Case of M/s Rhydburg Pharmaceuticals Ltd.

The undersigned Is directed to refer to DGFT U.O. No. 01/82/050/0G769/AM-

17/DES-III/613 dated the 23/11/2016 vide which application from M/s RhydburgPharmaceuticals Ltd. was sent to this Department for fixation of norms for the export

of Sitagliptin 100 mg tablets. This department has examined the matter and it is

submitted that the application Is grossly incomplete in even a copy of DML is notprovided and the application is not as per prescribed format.

2. In any case considering the standard export product being composed of

Sitagliptin Phosphate Monohydrate (Molecular weight 523.32) equivalent to 100 mg

Sitagliptin (Molecular weight 407.31), in line with SIGN A-412 following norms are

provisionally recommended subject to the RLA verifying the availability of a

valid DML for the export product.

Product to be Exported Raw materials to be Imported

Description Quantity Description Quantity

Sitagliptin 100 mg tablets (each tabletcontains Sitagliptin PhosphateMonohydrate equivalent to 100 mgSitagliptin)

1000

tablets

Sitagliptin PhosphateMonohydrate

131.051 gm



Phone: 23352298


Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi, Economic Officer, DES-IIIPhone No: 23061562. (269).

Udyog Bhawan, New Delhi

GOVERNMENT OF INDIA

MINISTRY OF SCIENCE & TECHNOLOGYDEPARTMENT OF BIOTECHNOLOGY

«nTfl

^ 3117

^TR>-2, 7^ •'StO ̂

cTrat '^f IqcmVnooosBlock-2, 7th Floor, C.G.O. ComplexLodhI Road, New Delhi-110003

BT/IL/05/316/2010-PIDDate: 05.06.2017

OFFICE memorandum

fhoil''*' for of '/O Norms forthe export of 62/0-DTwP-HepB-Hib-PentavaIent Vaccine (Easyfive TT)*

The undersigned is directed to refer to the Directorate General of Foreign Tradecommunications vide 1} HQ File Number 01/82/050/01127/AM15/-Dated:05 12 2014' 2) HOFile Number 01/82/050/01019/AM16/-Dated:28.10.2015: 3) HQ File Number

Number 01/82/050/00709/AM17/-

f f/n M ^ forwarding applications of M/s. Panacea Biotec Ltd., New Delhi, for fixationof I/O Norms for the export of different quantities of '62/0-DTwP-HepB-Hib-PentavalentVaccine (Easyfive TT) (single dose vial of 0.5 ml presentation)' requiring three import inputsnamely 1} punfied Dipthena Toxoid concentrate antigen bulk, ii) purified Tetanus Toxoidconcentrate antigen bulk and iii) Inactivated whole cell pertussis Bulk. As per the informationfurnished by the applicant, the I/O norms for the above four cases/applications are fixedherewith.

For export of 1 million vials (single dose vial of 0.5 ml presentation) of 'DTwP-HepB-Hib-Pentavalent Vaccine (Easyfive TT)', norm for the imported items are;

1. Purified Diptheria Toxoid concentrate antigen bulk (@ -2050 Lf/ml) = 13.64 Ltr2. Purified Tetanus Toxoid concentrate antigen bulk (@ -1900 Lf/ml) = 5.23 Ltr3. Inactivated whole cell pertussis bulk (@ -192 OU/ml) = 86.46 Ltr

This issues with the approval of Secretary, Department of Biotechnology.

O0^


To,Shri Nirmal Kumar

Deputy^lDGFTRoom No. 303, Directorate General of Foreign TradeMinistry of Commerce & IndustryUdyog Bhawan, New Delhi-01

s

Website: http://wvvw.dbtindla.nlc.ln http://www.btisnet.gov.jn^:WrBlephone : 24363012, 243G2329 "^Fax : 011-24362884

ISO

1^'



Room No. 302, 3^^ Floor,Janpath Bhawan New Delhi,


Office Memorandum

Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.!) 2009-14Case of Wl/s Aculife Healthcare Pvt. Ltd.

The undersigned is directed to refer to DGFT U.O. No. 01/82/050/00723/AM-17/DES-III/620 dated the 23/11/2016 vide which application from M/s AculifeHealthcare Pvt. Ltd. was sent to this Department for fixation of norms for the export ofIntravenous Fat Emulsion 10% w/v in 500 ml bottles. This department has examinedthe matter and the following norms are furnished against the export item in line withSIGN A-206 for injections above 10 ml and comparing with past consumption trend forproduction of Intravenous Fat Emulsion 10% w/v.



Intravenous Fat Emulsion 10%w/v in 500 ml bottles (each 100ml contains Soybean Oil-10 gm,Egg Lecithin-1.20 gm andGlycerol~2.25 gm)

100

bottles

1. Egg Lecithin 610 gm

2. Glycerol 1150 gm

3. Soyabean Oil 5100 gm

4. Glass Bottlel USP II 500 Ml As perpackingpolicy

5. 32 mm Ruber Stopper GreyBrb



Phone:23352298

Email: parveen. [email protected]

Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi, Economic Officer, DES-IPhone No: 23061562, (269),Udyog Bhawan, New Delhi

)V




Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14Case of Wl/s J.B. Chemicals & Pharmaceuticals Ltd.

The undersigned is directed to refer to DGFT U.O. No. 01/82/050/00395/AM-17/DES-1II/339 dated the 17/08/2016 vide which application from M/s J.B. Chemicals &Pharmaceuticals Ltd. was sent to this Department for fixation of norms for the export ofHexylresorcinol Sore Throat Relief Dual Action Lozenges Blackcurrant/Honey &Lemon/Black Cherry and other flavours. This department has examined the matterand the following norms are furnished against the export item:

Name of Export Product Quantity Inputs recommended Quantity for100 lozenqes

Hexylresorcinol Sore Throat ReliefDual Action LozengesBlackcurrant/Honey & Lemon/BlackCherry and other flavours (eachlozenge contains 4-Hexylresorcinol 2.4 mg)

100

lozenges

4-Hexylresorcinol(Hexylresorcinol)

0.2448 gm



Phone: 23352298


Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi, Economic Officer, DES-IPhone No: 23061562, (269),Udyog Bhawan, New Delhi


n-2-

F. NO.35011/353/2016-PI (Norms)

Government of India



Room No. 302, 3^^ Floor,Janp'ath Bhawan New Delhi,

Dated: September 6. 2017

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.l) 2009-14Case of WI/s Biotech Opthalmics Pvt. Ltd.

The undersigned is directed to refer to DGFT U.O. No. 01/82/050/00673/AM-

17/DES-III/580 dated the 31/10/2016 vide which application from Wl/s BiotechOpthalmics Pvt. Ltd. was sent to this Department for fixation of norms for the export of

Gloderm SOL, 1ml Pre-Filled Syringes (PFS) containing Sodium Hyaluronate 3%.

This department has examined the matter and the following norms are furnished against

the export item:


Description Quantity S.No Description Quantity pervial

Gloderm 30 L 3 % in 1

ml PFS vials (eachvial contain 30 mgcross linked Sodium

Flyaluronate)

100 vial 1. Cross Linked Sodium

Flyaluronate3.30 gm

2. Barrels /101 Nos. M3. Plunger Stopper 101 Nos.

4. Flypodermic Needle h 101 Nos.

5. Tyvek Lid v 101 Nos. 16. Blister ^ ^,101 Nos. /


(Parveen Kumar)Under Secretary to the Government-of India

Phone:23352298

Email: parveen.19(aiqov.in

Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi, Economic Officer, DES-lilPhone No: 23061562, (269), Udyog Bhawan, New Delhi 1 ^Email: [email protected] I ^

13^

pi\F.NO.35011/270/2016-P1 (Norms)

Government of India


Udyog Bhawan, New Delhi,Dated: October, 2016

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14Case of M/s Granules India Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/452 & 594/AM-17/DES-3/497 & 549 dated the 24/8/2016 & 6/9/2016 vide which application from M/sGranules India Ltd. was sent to this Department for fixation of norms under para: 4.7 forthe export of Ledipasvir Acetone Solvate. This department has examined the matterand the following norms are furnished under para 4.7 of Hand Book of Procedures(Vol.1) 2009-14:-


for Ikq Export

1 (6S)-6-[5-[7-[2-(1R.3S,4S)-2-Azabicyc!o [2.2.1] hept-■3-y!-1H-benzimidazoI-6-yl]-9,9-difluoro-9H-f[uoren-2-yl]-1H-imidazol-2-yl]-5-azaspiro [2.4] heptane Hcl(1:4)

0.965kg

2 N-Methoxy carbonyl-L-valine 0.70kg



PH:-23071162

Directorate General of Foreign Trade,Department of Commerce,(Shh M.V. Singh, FTDO),Udyog Bhawan, New Delhi.



Udyog Bhawan, New Delhi,Dated; July, 2016

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14Case of M/s Satya Deeptha Pharmaceuticals Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/245/AM-17/DES-3/196 dated the 4/7/16 vide which application from M/s Satya Deeptha PharmaceuticalsLtd. was sent to this Department for fixation of norms under para: 4.7 for the export of(1S,4R)-4-[(2-amino-6-chloro-5-formamido-4-pyrlmidlnyl) amino]-2-cyclo pentene-1-methanol. This department has examined the matter and the following norms arefurnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-


for 1kg Export

1 N-(2-amino-4.6-dichloro-5-Dvrimidinvl) formamide 0.764kg

2 (+)-2-azabicyclo [2.2.1] hept-5-en-3-oneWincelactam)

1.298kg

3 D(-) tartaric acid 0.78kq

4 Sodium borohydride 0.226kp

5 Isopropyl alcohol 4.18kq.

6 Methanol 4.75kg

7 L(+) tartaric acid 0.519kg



PH:-23071162

Directorate General of Foreign Trade.Department of Commerce,(Shh M.V. Singh, FTDO), Udyog Bhawan, New Delhi.



Shastri Bhawan.New Delhi,Dated the August 24, 2017

Office Memorandum

Subject: - Application from M/s J.B. Chemicals & Pharmaceuticals Ltd. for norms ofOxybutynin Chloride Extended Release Tablets 10 mg .

The undersigned is directed to refer to DGFT U.O.No. 01/82/050/00586/AM-17/DES-3/536 dated the 05/09/2016 vide which application from M/s. J.B. Chemicals &Pharmaceuticals Ltd was sent to this Department for fixation of norms under para: 4.7 forthe export of Oxybutynin Chloride Extended Release Tablets 10 mg. The applicationof the unit has been examined and following quantities are recommended for one tabletof lOmg Oxybutynin chloride Extended Release.

S. No. Import Item Qty. Recommended

1. Oxybutynin chloride USP 10.02mg/tablet

2. Sfintry Pnlyox WSR N80 FP NF 80.77mg/tablet

3. Sentry Poiyox WSR 303 NF 41.10mg/tablet

2. This issue is with the approval of Competent Authority.

(Parveen Kumar)

Under Secretary to the Government of IndiaPhone:23352298


Directorate General of Foreign Trade,Department of Commerce,(Shri Panigrahi, Dy DGFT),Room No. 414, Udyog Bhawan, New Delhi



Shastri Bhawan, New Delhi,Dated: April 13. 2017

Office Memorandum

Sub: - Fixation of norms under para 4.7- Application of M/s Cadila Pharmaceuticals Ltd.,for export of Clindamycin Capsules 150 mg.

The undersigned is directed to refer to DGFT U.O. No. 01/82/050/1050/AM-17/DES-3/1046 dated 02/03/2017 and subsequent letter from M/s Jubilant GenericsLtd.. for fixation of norms against export of Clindamycin Capsules 150 mg. Theapplicant has requested for import of relevant bulk drug i.e. Clindamycin Hydrochlorideonly as approved in the DML.

2. The SIGN for tablets are published vide S. No. A-412 and the application may beprocessed accordingly.

3. This issues with the approval of competent authority


Phone: 23323292


Directorate General of Foreign Trade,Department of Commerce,(Shrl Nirmal Kumar, Dy DGFT),Udyog Bhawan, New DelhiEmail: [email protected]



Room No. 302, 3^^ Floor,Janpath Bhawan Ne\w Delhi,Dated: September 12, 2017

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14Case of M/s Zim Labs Ltd.

The undersigned is directed to refer to DGFT U.O. No. 01/82/050/00760/AM-17/DES-III/630 dated the 23/11/2016 vide which application from M/s Zim Labs Ltd. wassent to this Department for fixation of norms for the export of NicardipineHydrochloride SR Pellets 50 mg. This department has examined the matter and thefollowing norms are furnished against the export item:



Nicardipine Hydrochloride SRPellets 50 mg (230 mg SR Pelletscontain 50 mg NicardipineHydrochloride)

1 kg NicardipineHydrochloride

0.2196 kg



Phone: 23352298


Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi, Economic Officer, DES-IPhone No:-23061562, (269),Udyog Bhawan, New DelhiEmail: [email protected]

11^

'2,53'



Janpath Bhawan, New Delhi,Dated: November 18, 2016

Office Memorandum

Sub: - Fixation of norms under para 4.7-Application of M/s Sentiss Pharma (P) Ltd.

The undersigned is directed to refer to DGFT U.O. No. 01/82/050/01717/AM-16/DES-3/1883 dated 22/03/2016 and subsequent letter from M/s Sentiss Pharma (P) Ltd. for fixation ofnorms against export of Inokain Eye Drops. This department has examined the matter and


8.

No

Description Quantity Description Quantity for100 vials

1. Inokain Eye Drops 5 ml vial(each ml contains BenoxinateHydrochloride 4 ma)

100 vials Benoxinate

Fiydrochloride2.1 gm

2 This issues with the approval of Director (Pharma Industry).(Barnali Khastgir)

Under Secretary to the Government of IndiaPhone: 23323292


Directorate General of Foreign Trade,Department of Commerce,(Shri Nirmai Kumar, Dy DGFT),Udyog Bhawan, New DelhiEmail: [email protected]



Shastri Bhawan.New Delhi,Dated the August 30, 2016

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures about request of M/s J.B. Chemicals Pharma Ltd.

The undersigned is directed to refer to various representations submitted by M/s J. B.Chemicals Pharma Ltd. to the DGFT and copies endorsed to the DoP, requesting foramendment in the description of export product and inputs-to be imported against export of (i)Bupivacaine Hydrochloride 0.5% in Dextrose Injection in 4 ml Ampoules and (II)Buplvacalne with Adrenaline Injection In 20 ml Ampoules.

2) A glance through the representation arid calculations undertaken in the Department, there isa need felt for amendment in the description of export products as well as the correspondingraw materials recommended to be imported. Considering different level of wastage permissiblefor injections up to 10 ml vials and above 10 ml vials, the norms conveyed earlier may bereplaced as follows: -

S. No Export Product ImportProduct

QuantityRecommended

1. Bupivacaine Hydrochloride 0.5%in Dextrose Injection in 4 mlAmpoules (each ml contains 5 mgBupivacaine Hydrochloride)

BupivacaineHydrochloride

22 mg per vial of 4 ml

2. Bupivacaine with AdrenalineInjection in 20 ml Ampoules(each ml contains 5 . mgBupivacaine Hydrochloride and0.0091 mg of AdrenalineBitartarate)

1) BupivacaineHydrochloride

105 mg per vial of 20 ml

2) AdrenalineBitartarate

0.1911 mg per vial of 20mi



Phone: -23071162



Case No.: 15/19/82-

ALC4/2013

Party NameiAMINES &PLASTICIZERS LIMITED


ALC4/2013

02.01.2014

Status:Case

Approved

HQ File

:0I/82/050/00960/AM14/

RLA File

:03/94/040/00661/AM14/


1

06.11.2013

Defer Date:

23

0

Decision : In the light of written comments received from- Department of Chemicalsand Petrochemicals vide their UO No. 14010/61/2011-Ch II dated 02.01.2014, it wasdecided to ratify norms under Para 4.7 of HBP vl as per details given below or asapplied by the firm, whichever is less:

\

Export product Exp.Qty.

Sl.No. Import items Qty. allowed |

N-METHYL

MORPHOLrNE fNMM)I kg 2.

Morpholine 1.001kg j

RA may take appropriate action as per the decision of Norms Committee.

1^1


Ministry of Chemical & FertilizersDepartment of Phannaceuticals

New Delhi, the 24^'* December, 2013

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/sCadila Healthcare Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/281/AM-14/DES-3/383 dated ̂ e08/08/13 vide which application from M/s. Cadila Healthcare Ltd was sent to this Department for fixationof norms under para: 4.7 for the export of Potassium Citrate Extended Release Tablets. Thisdepartment has examined the matter and the following norms are furnished under para 4.7 of Hand Bookof Procedures (Vol.1) 2009-14;-

Udyog Bhawan,

For Export of 1 Million No.Tablets.

S.No. Import Item 5m Eq 10.0m Eq 15.0m Eq

1. Potassium Citrate USP 550.8 kg 1101.60 kg 1652.40 kg

2. Carnauba Wax (EZ-COAT CWM) NF 137.85 275.70 290.0

3 to 7. Bottles and Caps Relevant, as per packing policy.


(Raj Kumar)

Under Secretary to the Government of IndiaPI-Norms

Directorate General of Foreign Trade,Department of Commerce,(Shri R.C. Meena, Dy. DGFT), Udyog Bhawan, New Delhi.



*****

Shastri Bhawan.New Delhi.Dated the April 3, 2017

Office Memorandum

Subject: - Application from M/s Cadila Healthcare Ltd. for norms of Pyridostigmine BromideTablets 60 mg.

The undersigned is directed to refer to DGFT U.O.No. 01/82/050/00602/AM-17/DES-3/541 dated the 06/09/2016 vide which application from M/s. Cadila Healthcare Ltd. was sent tothis Department for fixation of norms under para: 4.7 for the export of Pyridpstigmine BromideTablets 60 mg. This department has examined the matter and the following norms are furnished:


Description Quantity S.

No.

Description Quantity for1000 tablets

PyridostigmineBromide Tablets

60 mg (eachtablet containsPyridostigmineBromide 60 mg)

1000

tablets

1. Pyridostigmine Bromide 61.200

2. Hvdroxy Propyl Cellulose 4:880-9m.

3. Lacfose Anhydrous 297.37Q-gm--

4. Bottle 75CC White HDPE -As-pei;-paekmgPolicy^

5. 33 mtb -400 PP CRC CAP (White HS 123Liner)\\

6. Desicc'^nt Canister 2 g7. Packin^sert (Pyridostigmine Bromide

Tablets) \


Barnali Khastgir)



Directorate General of Foreign Trade,Department of Commerce,

• (Shri Nirmal Kumar, Dy DGFT),Udyog Bhawan, New DelhiEmail: [email protected]



Udyog Bhawan. New Delhi,Dated: July, 2016

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case ofWl/s Anuh Pharma Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/116/AM-17/DES-3/99dated the 23/5/16 vide which application from M/s Anuh Pharma Ltd. was sent to thisDepartment for fixation of norms under para: 4.7 for the export of Dexamethasone SodiumPhosphate. This department has examined the matter and the following norms are furnishedunder para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-

S.No. Import item Norms Recommended for

Ika ExDort

1 Dexamethasone 0.78kg


(Rajkumar)

Under Secretary to the Government of IndiaPH:- 23071162

Directorate General of Foreign Trade.Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi



Udyog Bhawan. New Delhi,Dated: July, 2016

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case ofWl/s Envee Drugs Pvt. Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/88/AM-17/DES-3/130dated the 23/5/16 vide which application from M/s Enyee Drugs Pvt. Ltd. was sent to thisDepartment for fixation of norms under para: 4.7 for the export of Clobetasole propionateBP/USP. This department has examined the matter and the following norms are furnished underpara 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-

S.No. Import item Norms Recommended forIka ExDort

1 Betamethasone I.OOkq


(Rajkumar)

Under Secretary to the Government of IndiaPH:-23071162

Directorate General of Foreign Trade,Department of Commerce.(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi



Mo

Shastri Bhawan, New Delhi,Dated: April 12 2017

Office Memorandum .

Sub: - Representation against norms allowed in respect of an Application from M/s^^&^yt^__L^l>^Ltd., forexport of Atovaquone

The undersigned is directed to refer to DGFT U. 0. No. 01/82/050/379/AM16/DES-3/1020 dated23.02.2017 forwarding a representation against norms allowed against export of Atovaquone Bulkdrug. The applicant has requested to increase the quantity of various inputs based upon a certificateissued by the Superintendent of Custom & Central Excise, Kazipally Range, Secunderabad.

2) It may be recalled that norms as given below were permitted based on DoP's comments. The normsas per CE Certificate are indicated in last column of the following table:

V-

8. No. Import Item

Qty. Recommendedkg/kg.

Quantities as per CE

Certificate

^1.

4~(4-ChlorophenyI) Cylohexyl CarboxylicAcid 2.00 1 3.577

• 2. 2-Chloro-1,4-Naphthoquinone 1.62 3.605

Setphotane M:00

T0lueRe=f' ^^:4e -mTess-

5. Acetonitrile --6:65 -4§:663

DictiloTOIgthane^

7. MethanDt==^ ' -76:686-

3) It is also to be pointed out that the certificate has been issued based upon a Chartered EngineerCertified Data and at the request of the company. It is also stated that norms equivalent to thoseallowed to M/s Mylan Laboratories Ltd. have also been adopted while processing other applications fromdifferent Pharma companies for the same export product.

4) In view of the foregoing, there is no ground for higher norms based upon the CE certified figures thathas been merely issued based upon data provided by a Chartered Engineer and as per request of thecompany without any objective assessment of manufacturing process or accounting for valid recoveriesof solvents etc.

5) This issues with the approval of competent authority

(Barnali Khastgir)Under Secretary to the Government of IndiaPhone: 23323292/Email: [email protected]

Directorate General of Foreign Trade,Department of Commerce,(Shri Nirmal Kumar, Dy DGFT),Udyog Bhawan, New Delhi/Email: [email protected]



j

Room No. 302, 3^^ Floor,Janpath Bhawan New Delhi,Dated: September 6, 2017

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case ofWI/s Biotech Opthalmics Pvt. Ltd.

The undersigned is directed to refer to DGFT U.O. No. 01/82/050/00673/AM-17/DES-111/580 dated the 31/10/2016 vide which application from M/s. Biotech Opthalmics Pvt. Ltd. wassent to this Department for fixation of norms for the export of Gloderm SOL, 1ml Pre-FllledSyringes (PFS) containing Sodium Hyaluronate 3%. This department has examined thematter and the following norms are furnished against the export item:


Description Quantity S.No Description Quantity pervial

Gloderm 30 L 3 % in 1

ml PFS vials (eachvial contain 30 mgcross linked SodiumHyaluronate)

100 vial 1. Cross Linked Sodium

Hyaluronate

3.30 gm

2. Barrels 101 Nos.

3. Plunger Stopper 101 Nos.

4. Hypodermic Needle 101 Nos.

5. Tyvek Lid 101 Nos.

6. Blister 101 Nos.



Phone: 23352298


Directorate General of Foreign Trade.Department of Commerce,(Shri S.K. Panigrahi, Economic Officer, DES-lllPhone No: 23061562, (269), Udyog Bhawan, New DelhiEmail: [email protected]



lyw'?

New Delhi, the

Udyog Bhawan,October, 2014

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/sCTX Life Sciences Pvt Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1195/AM-14/DES-3/ dated the26/03/14 vide which application from M/s. CTX Life Sciences' Pvt Ltd was sent to this Department forfixation of norms under para: 4.7 for the export of Irbesartan. This department has examined the matterand the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-

I

S.N^ Import Item Qty. Recommended kg/kg.

2-cyano-4-bromomethyl biphenyl 1.02

Petassium-earbenate- 2:09

2-n-butyl-l,3-diazospiro[4,4] non-4-ene HCL 0.88

4^TrrethyTammeTfGL 0 89

—Sedium-azide- 0 49

—Sodium_nitnt^ 0.48

—■EtltyPaeet-ate 2.86

—Ax ti vate d-carben—^ 0.1^0


(Bamali Khastgir)Under Secretary to the Government of India

Directorate General of ForeignTrade,Department of Commerce,(Shi'i M.V. Singh, FTDO),Udyog Bhawan, New Delhi

Sub:

F. No.35011/494/2012-PI (Norms)Govermiient of India


Udyog Bhawan,New Delhi, the 1?"'October, 2012.

Office Memorandum

Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-Hetero Labs Ltd.

14 Case of M/s

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/197/AM13/DES-3/325 dated the28/05/12 vide which an application from M/s Hetero Labs Ltd was sent to this Department for fixation ofnorms under para; 4.7 for the export of Lisinopril. This department has examined the matter and thefollowing comments are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-


1.

N2-[(lS)-Ethoxy carbonyl-3-phenyl-propyl]-N6-Trifluoroacetyl-L-Lysine 1.92

2.L-Proline0.927

3.N,N-Carbonyldiimidazole 0.400

4.Methanol2.82

5.Methylene Chloride 9.59

6.Isopropyl alcohol 2.77

2. This issues with the approval of Director (Cost).

(N.N.Ahuja)Section Officer

PI-Nonns

Directorate General of Foreign Trade,Department of Commerce,(Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi.

I 'll

kaVF. NO.35011/96/2012-PI (Norms)

Government of India


Udyog Bhawan,New Delhi, the July, 2012.

Office Memorandum

Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-Ranbaxy Labs Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1091/AM12/DES-3/1615 datedthe 16/01/12 vide which an application from M/s Ranbaxy Labs Ltd was sent to this Department foifixation of norms under para: 4.7 for the export of Clarithromycin Carbomer Granules 27.5% /department has examined the matter and the following comments are ftirmshed under para 4.7 of HandBook of Procedures (Vol.1) 2009-14;-

14 Case of M/s


1.Carbopol 974P 0.20

2.

Clarithromycin OR Its raw materials as per SIGNA-2263 on pro-rata basis. 0.2777

2. ' This issues with the approval of Economic Advisor.


PI-Norms

Directorate General of Foreign Trade,Department of Commerce,(Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi. / 3

/

,•9^

/

i) f <5

- /i.f- ■' ——-

Sub:



New Delhi, the

Office Memorandum

Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-Kopran Ltd.

Udyog Bhawan,September, 2012.

14 Case of M/s

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1181/AM12/DES-3/1755 datedthe 13/02/12 vide which an application from M/s Kopran Ltd was sent to this Department for fixation ofnorms under para: 4.7 for the export of Pregabalin. This department has examined the matter and thefollowing comments are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-


1.(±) 3-(Carbamoyl Methyl)-5-Methylhexanoic Acid 2.94

2.Chloroform 4.75 Ltr/kg

3.R(+)-Methyl Benzyl Amine 0.114 kg/kg

4.Iso Propyl Alcohol 0.96 Ltr/kg



PI-Norms

Directorate General of Foreign Trade,Department of Commerce,(Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi.



Office Memorandum

Shastri Bhawan, New Delhi.Dated: March 27, 2017

Sub: - Fixation of norms under para 4.7- Application of M/s BDR Pharmaceuticals International (P)Ltd.

The undersigned is directed to refer to DGFT U.O. No. 01/82/50/00320/AM-17/DES-3/264dated the 08/07/2016 vide which an application from M/s BDR Pharmaceuticals International (P) Ltd.was sent to this Department for fixation of norms against export of Tamoxifen Tablets BP 10 mg &20 mg. The application has been examined and following norms are recommended


S. No. Description Quantity Description Quantity for1000 Tablets

1. Tamoxifen Tablets BP 10 mg (eachuncoated Tablet contains: TamoxifenCitrate equivalent to Tamoxifen 10 mgj_

1000 tablets Tamoxifen Citrate 15.473 gm

Tamoxifen Tablets BP 20 mg (eachuncoated Tablet contains: TamoxifenCitrate equivalent to Tamoxifen 20 mg)

1000 tablets Tamoxifen Citrate 30.946 gm

2) The above norms are being conveyed subject to verification of availability of valid DrugManufacturing License for both compositions of the export product by the RLA. This isprovided in view of the fact that copy of DML available with the application do not have the list ofapproved medicines.

3) Considering the fact that, the referred compositions of Tamoxifen are standard formulations, basedon the molecular weight co-relation for Tamoxifen base and its citrate salt and allowing admissiblewastage as per SIGN A-412, above quantities of Tamoxifen Citrate, against respective applicationsrecommended as Norm for 1000 tablets of 10 mg & 20 mg against this application, may also beconsidered for publication as SIGN for the above two export products.

4) This issues with the approval of competent authority.Barnali Khastgir)



Directorate General of Foreign Trade,Department of Commerce,(Shri Nirmal Kumar, Dy DGFT).Udyog Bhawan, New DelhiEmail: [email protected]



New Delhi, the

Udyog Bhawan.September, 2014

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14 Case of M/s Nectar Life Sciences Ltd.

The undersigned is directed to refer to DGFT U.O.No. 0I/82/50/408/AM-14/DES-3/950 dated the 26/11/13 vide whichapplication from M/s. Nectar Life Sciences Ltd was sent to this Department for fixation of norms under para: 4.7 for the export ofCefixime Trihydrate. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Bookof Procedures (Vol.1) 2009-14:-


U' 1. GCLE 1.507

2. Sodium bromide 0.3628

J. Tri Phenyl Phosphine 0.820

v--4. DMF 1.869

5. Methylene Chloride 1.546 .

6. Formaldehyde 1.118

7. Methanol 5.117

8. Phenol 0.3808

U- 9. Butyl Acetate 0.302

V-10. Eno Carbon 0.100

11. Acetone 0.793

0.0182

" 13. MICA Ester 0.820

U4,—Aeetie-Aeid— 0.030

15. Triethylamine (TEA) 0.2717

Eth)4-Acetate ■ 0.376



(Barnaii Khastgir)

Under Secretary to the Government of IndiaPl-Norms



New Delhi, theUdyog Bhawan.November, 2014

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s Dr.Reddy's Labs Ltd.

The undersigned is directed to refer to DOFT U.O.No. 01/82/50/213/AM-15/DES-j/78 dated the08/05/14 vide which application from M/s. Dr. Reddy's Labs Ltd was sent to this Department for fixation ofnorms under para: 4.7 for the export of Capecitabine. This department has examined the matter and thefollowing norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-

S.Tlo. Import Item Qty. Recommended kg/kg.

1. 2,3-Di-0-acetyl-5-deoxy-5-fluorocytidine 1.19

2. N-Pentyl Chloro Formate 0.813

Methylene Chloride 4.20



Directorate General of Foreign Trade,Department of Commerce,(Shi-i M.V. Singh, FTDO),Udyog Bhawan, New Delhi

F.NO.35011/378/2016-PI (Norms)Government of India


Office Memorandum

Shastri Bhawan, New Delhi,


Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.I) 2009-14,Application of M/s Morepen Laboratories Ltd.

■ The undersigned is directed to refer to DGFT U.O. No. 01/82/50/632/AM-17/DES-3/548 datedthe 03/10/2016 vide which an application from M/s Morepen Laboratories Ltd. was forwarded to thisDepartment for fixation of norms for the export of Atorvastatin Calcium. This department hasexamined the matter and the following norms are recommended against this application:-

S.No. Import Product Nonns Recommended

1 (4R-Cis)-l,l-Dimethylethyl-6-Cyanomethyl-2,2-Dimethy 1-1,3 -Dioxane-4-Acetate

0.708kg

2 4-Fluoro-alpha-[2-methyI-l-osopropyl]-gamma-oxo-N-beta-diphenyl benzenebutanamide

1.15kg

3 Methanol 6.42kg

4 Methyl Tert-Butyl Ether (M20F) 2.78kg

5 Tetrahydrofliran 0.80kg

6 Methylene Chloride 4.48kg

7 Diisopropyl ether 3.90kg


(Parveen Kumar)

Under Secretary to the Government of IndiaE-mail: parveen.19(ggov.in

Ph;-23352298

Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi),Udyog Bhawan, New Delhi.E-mail: [email protected]'

Ph: 23061562, Extn.269

r




Office Memorandum

Subject; - Fixatiory^f norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14 Case of WI/sAnuh PKamfa Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/709/AM-16/DES-3/781 datedthe 10/8/15 vide which application from M/s Anuh Pharma Ltd. was sent to this Department forfixation of * norms under para: 4.7 for the export ofBetamethasone Valerate BP/USP/EP/IP. This department has examined the matter and thefollowing norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-

S.No.^ Import Item Norms Recommended

for 1kq Export

C1^ Betamethasone BP/USP/EP/IP 0.915kg

2— ^FBfflethyFGfth o - Va 1 o rato -Gr^ekg-


(Rajkumar)





Udyog Bhawan.New Delhi, the August, 2014

Office Memorandum

Subject:- Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14 Case of M/s Intas Pharma Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/825/AM-14/DES-3/982 dated the 26/11/13 vide whichapplication from M/s. Intas Pharma Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of LithiumCarbonate FC Tablets 250mg and 400mg . This department has examined the matter and the following norms are furnished underpara 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-

S.No. Import Item

For Export of 1000 Tablets

250 mg tablets 400 mg tablets

1. Lithium Carbonate PH. EUR./USP 0.255 kg 0.408 kg

2. Hypromellose 0.0107 0.0172

J. Magnesium Stearate 0.005 0.008

4. Maize Starcdh 0.0683 0.1092

5. Sodium Starch Glycolate 0.010 0.016

6. Ethanol 0.2791 0.4505

7. Lactose Monohydrate 0.130 0.208

8. Povidone 0.020 0.032

9. 5Ply Plain Shipper Relevant, As per packing policy.

10. HOPE Bottle

11. PP CR Closure


Directorate General of Foreign Trade,Department of Commerce,(Sliri M.V. Singh, FTDO),Udyog Bhawan, New Delhi

(Raj Kumar)

Under Secretary to the Government of IndiaPI-Norms

F. N0.35OII/222/2OI6-PI (Norms)Government of India


Shastri Bhawan, New Delhi.Dated: September 11, 2017

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2015-20 Case of M/s XJt^kfiaxLaboratories Pvt. Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/386/AM-17/DES-3/440 dated the19/08/2016 vide which application from M/s Unimax Laboratories Pvt. Ltd. was sent to this Department forfixation of norms under para: 4.7 for the export of Betamethasone Dipropionate BP 2009/BetamethasoneDipropionate. This department has examined the matter and the following norms are fiirnished under para 4.7of Hand Book of Procedures (Vol.1) 2015-20:-


for 1kg Export

1 Betamethasone 0.868kg


(Parveen Kumar)

Under Secretary to the Government of IndiaE-mail: parveen. [email protected]

Ph: 23352298

Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi),Udyog Bhawan, New Delhi.E-mail: [email protected]

Ph: 23061562. Extn.269

15^



Udyog Bhawan,New Delhi, the April, 2015

Office Memorandum

Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case olM/s. VhaHbabsTtdT

The undersigned is directed to refer to DGFT U.O.No. 0I/82/50/670/AM13/DBS-3/831dated the 22/01/15 vide which an application from M/s. Vital Labs Ltd was sent to thisDepartment for fixation of nonns under para: 4.7 for the export of Methyl Cobalamin J.P(Mecobalamin). This department has examined the matter and the following comments arefurnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-


1. Vitamin B 12 (Cyanocobalamin) 0.95


(Barnali Khastgii")Under Secretary to the Government of India

Phone-23071162


/T9

F.NO.35011/209/2016-PI (Norms)Government of India


Udyog Bhav\/an, New Delhi,Dated: September, 2016

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.!) 2009-14 Case of WI/sDivi's Labs Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/505/AM-17/DES-3/336 datedthe 17/8/2016 vide which application from M/s Divi's Labs Ltd. was sent to this Department for fixationof norms under para: 4.7 for the export of Naproxen. This department has examined the matter andthe following norms are furnished under pa>a 4.7 of Hand Book of Procedures (Vol.!) 2009-14:-

S.No. Import item Norms Recommendedfor 1kg Export ■

1 DL-Naoroxen 1.17kg

2 N-Octyl-D-Glucamine 0.0882kg

3 Methanol 2.02kg

4 . Acetic acid 0.54kg

5 Toluene 0.84kg


(Rajkumar)



fCo


Ministry of Ghemicai & FertilizersDepartment of Pharmaceuticals

^ !

Janpath Bhawan, New Delhi,Dated: September 15, 2017

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2015-20 Case of WI/sCadila Healthcare Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/356/AM-17/DES-3/333 datedthe 17/08/2016 vide which application from M/s Cadila Healthcare Ltd. was sent to this Departmentfor fixation of norms under para: 4.7 for the export of Acebutolol Zydus 200mg, 400mg Tablets;This department has examined the matter and the following norms are furnished under para 4.7 OfHand Book of Procedures (Vol.1) 2015-20:-

S.No. Import Item Norms Recommended

200mg 400mg

1 Acebutolol Hcl PH EUR 204mg per tablet 408mg per tablet


Directorate General of Foreign Trade.Department of Commerce.(Shri S.K. Panigrahi, Economic Officer. DES-IPhone No: 23061562, (269).Udyog Bhawan. New DelhiEmail: [email protected]

(Parveen Kumar-

Under Secretary to the Government of IndiaPhone: 2335229S


1^;



0^\y\

Udyog Bhawan,New Delhi.Dated the August, 2015

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s SnamLabs Pvt Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1047/AM-15/DES-3/1069 dated the13/01/15 vide which application from M/s. Sriam Labs Pvt Ltd was sent to this Department for fixation o.norms under para: 4.7 for the export of (lS,4R)-4-Amino-2-Cyelopentene-l-MethanoI Tartrate (Cap-2). Thisdepailment has examined the matter and the following norms are furnished under para 4.7 of Hand Book oiProcedures (Vol.1) 2009-14:-


1. Vincelactum 1.337

2. Sodium Borohydride 0.214

J. D (-)-tartaric Acid 0.90

Bamali Khastgir)

Under Secretary to the Government of IndiaPhone:23071162


0 >



Udyog Bhawan, New Delhi,Dated: 2. May 2016

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.1) 2009-14 Case of M/s Sriam Labs Pvt.Ltd.

The undersigned Is directed to refer to DGFT U.O.No. 01/82/50/1186/AM-16/DES-3/1299 dated the 16/12/15vide which application from M/s Sriam Labs Pvt.Ltd. was sent to this Department for fixation of norms under para: 4.7 for the exportofOiethyl (3,5-dimethoxy benzyl) phosphonate (ADDP-2).This department hasexamined the matter and the following norms are furnished under para 4.7 of FlandBook of Procedures (Vol.1) 2009-14:-

S.No. Import Item Norms Recommended

for 1kg Export1 3,5-dihvdroxv benzole acid 0.667kg■2 -T^otaSsiufn carbonate VF94kg3 Sodium borohydride 0.423kg4 Triethyl phosphite 0.932kg

2. This Issues with the approval of competent authority.


PH:- 23071162


\^j>



Udyog Bhawan,New Delhi, the October, 2014

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Caseof M/s Hetero Labs Ltd.

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1233/AM-14/DES-3/39dated the 25/04/14 vide which application from M/s. Hetero Labs Ltd was sent to thisDepartment for fixation of norms under para: 4.7 for the export of Losartan Potassium. Thisdepartment has examined the matter and the following norms are furnished under para 4.7 ofHand Book of Procedures (Vol.l) 2009-14:-


1. 2-butyl-4-chloro-5-formyl imidazole 0.50

2. 4-bromo methyl-2-cyano biphenyl 0.866

3. Sodium borohydride 0.048

4. Toluene 1.45

5. Methanol 0.85

6. n-methyl pyrrolidone 0.769




V /

-V

/» ^• A

a>i'.

®fcii50|il35g9^-PI (Norms)Government of India


o I

Udyog Bhawan, New Delhi,Dated: 22 March, 2016

Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.I) 2009--14jCase^of-IV1/s_RA Chem Pharma Ltd. _

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/839/AM-16/DES-3/923 dated the 8/9/15 vide which application from M/s RA Cham Pharma Ltd.was sent to this Department for fixation of norms under f5ara: 4.7 for the export ofEntacapone. This department has examined the matter and the following norms arefurnished under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14:-

S.No. Import Item Norms Recommendedfor 1kq Export

1 Vanillin 2.306kg

2 Pyridine 1.02kq

3 Diethyl Amine 1.437kq

4 Toluene 1.35kq

5 Methanol 0.62kg

6 Ethyl Acetate 2.56kgn nCUn

I 7 I Ethyl Cyano Actate

X

>' s

0


(Rajkumar)

Under Secretary to the Government of IndiaPH:- 23071162


o m • X^ ••• I

: {. ••

i

Case No.:17/27/82-ALC4/2008 Party Name:ORGANICAAROMATICS PVT LTD


ALC4/2009

07.07.2009

Status:

Approved.

HQ File:01/82/050/01034/AM09/

RLA File

:07/24/040/00280/AM09/


19.09.2008

36

Decision : Committee considered case as per agenda and in light of written comments ofDept. of C & PC conveyed vide U.O. No. 14010/132/2004-Ch.Iir dated 19.3.2009decided to ratify norms under Para 4.7 of Handbook of Procedures as per details below oras applied for by firm whichever is lower

Export Product ExportQuantity

S.No. Import Item Quantity allowed

AlphaDamascone

1.00 Kg. 1 Citral 1.583 Kg.

Beta

Damascone

1.00 Kg. 1 Citral 1.583 Kg.

. RA concerned may take further necessary action as per above decision of NC.

GC

7.*

Government of IndiaMinistry of Chemicals and Fertilizers

Department of Chemicals and Petrochemicals %

Subject: 3PP"':ati°'Vfrom M/s. Tide Indusfries for the import of rawmatenal against the export of Rose Oxide etc.

- \u-v

norms Department recommends the followingnorms for the present Advance Authorization application.

*1. Item of Export QtvAldehyde C12 Laurie 1 kg

ucm sji inifJUl I

1. C-12 Fatty Alcohol(Lauryi Alcohol)Qty1.725 kg ■r7>

1. Item of ExportLauryl Nitrile

Qty.1 kg

item of Import1. Laurie Acid 1.22 kg

i yi cj/

I {'■

1. Item of ExportL- Rose Oxide

1. item of ExportRose Oxide

Qty.1 kg

Item of Import1. L Citronellol

Qty. Item of Importt kg 1. Citrai (Citral Synthetic)


Qty3.269 kg

Qty4.17 kg

♦••-A

(A.K. AGARWAL)Addl. Industrial Adviser

Tel. No. 011-23381430

Shrl Mahender Vikr-am Sinqh.FTDO fPES-lin O/n nnPT. Udvpg Rhnwan Npw n.inr _11Deptt. of C&PC U.O. No. 14010/40/2011-CH-ll dated 04.03.2016

'g- ItnF. No,35011/173/2016-PI-Norms -5^;;

Governmeni 01' IndiaMinistry of Chenilcal &. FertilizersDepartment of Pharmaceuticals

Shastri Rliav/an,• New Delhi, the- September 26. 2016

/ Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14 Caseof Nils Aurobindo Pharma Ltd.

The utRiersigned is ciitected to refer to DGFT U.O. No. 01/82/50/1576/AM-16/DES-3/244 dated tlie 03/07/2010 vide whicti application from M/s Aurobindo Pharnia Lid. was sentto this Department for fixation of norms under para: 4.7 for the export of PGnicillin Vpotassium 600 ing Tablets and 250 mg Tablets. This department has examiped'the matterand the foilovv'ing norms arc furnished under para 4.7 of Hand Book of Procedures (Vol.!)2009-14: -

No Import Item - Norms Recommended

I ; _ ! ^500 mg • t 250,iTig iI 1. ; Phenoxymei'hyl Penicillin Pot"assiun-i 5'05.5nTg75M^^i . I ^Jassium)__ Tablet " i Tablet \

2) This issues wiij-i the approvul of compeleht authority.

Direciornte General of Foreign Trade,.Depcirlmenl oi Conimerce.

(Shri IvLV. Singh, FTDO),IJdyog Bhawan. New Delhi- ) ID011

(Ftaj Kumar)Under Secretary to ti'ie Government of India

Phone:-23071162


F.NO.35011/351/2016-PI-Norms ^ ̂Government of inciid

^'"'®'7°fGhemicaUFer%ers ' 'Departmenjpf Pharmaceuiica^^

■ • Shastri Bhawan

^ ̂ r-- ■ - - ■ -ip ÔN.fpr

2) It may also ̂ be mentioned filat^^Barac^tamdi ^ - ^ \ " ' - . ^TOsseS:ThS5„,y„-j,j-g

KfSH?i ""«■ ™W'SNWMslSssS30m§s^ Quariiity

A-3488 f~u^— 1' JllPÂmino Phenol—

0.95 kq0.95 ko 0.91 kq,.(?l^tiÂnhyd7idi I^SST^ !

3) The applicani has claimed thai as anain.:f fhoreflected in the SION A-3488, the company fs achiS'""'! nSrSS ~Anhydride ©oIt 'S^'ytd ̂ af^TTrr"' "requirement works out to 0.80 kg of PAP and n yr . purification, theParacetamol. It is also worth pointing out that Ih/r Anhydride for each kg ofreported by some otherPharmaceuticals Ltd., in connection wilh their inwri? Jamisonhave been even lower lhan 0.75 kg/kg. appiications for Acetic Anhydride

.2/-

\ \

F No.3j011/351/2016-P|-Nomis ^ ̂- Government of (ndid

Mmistiy of Chemical S FeililizersDepartmenf ofPhirmaceutic# , • ,

■ . . . ...... -i Bhawan7,2017

2) It Wa^ also 'Pe menticinea tiial F ■ ' ■ -

Iff

A-3488 pTj^1 (2) smirniRMln

— -pMSjicA^^ S ^

■ --

re fcL?;S"sS ««? f' " o, PAP a„e ^p,»,„s p, Aoe„c A„p 2 ■r.rr,.r;,7 t" "••"consumption ,n the PAP route. . benchmarlr of raw mateiS

reported by so,me other n.a,u,facture,s i, Ir 2 o 1 """'f AnhydridePha,-mac.eut,cals Ltd. , in connection with tiebm no L '''' '^'rnsonhave been even lower than 0.75 kg/kg. ®® ^l^piications for Acetic Anhydride

.21-

17 o

-2-

5) In view of the foregoing, DGFT may consider amendment in the SIGN A-3488 as explainedabove. Simultaneously, the ghj"ntijy"6f A jn.SIGN A:343 niay also ,be revisedto 0.7.5 kg/kg in place of 0.95;kg/kg: thi's is,being recomiriended in view of the fact that AceticAnhydride is used in last stage of both of the processes for conversion of Para Amino Phenbltp^paxecetamoj. The revised .SipN.tpXepjdcl® ahd A-3488 Would be affollofe

SuahfityTyf:Paf^ T ■ Pflllgjp ̂3IW^Mag^ '7 T ',Quahiijy'pef'kg''.-TiilsiEyi.v.r-J2);;^t|iymil;^ .-e'.

i:7--Ar3488 , v ■M<g Y' ^[l);'|^m|^mihdWehbl '' ."' ' .T- :o.i80]eg=:;:_' -

.. .;j ;p.- V-,; ' - v i,;.': ■(2)i j^tiÂmhydnde -"T ' .,.■7 ' ■ ■ . 'DlTS^kg^ T.7 V -

6) bCFT may also consider .fo ufidertake-d rey^^ SlONs for conventional drugs andallied products; Jhis rfiay /be contempidfeJppîe^

, auye.iiCîiiefits,; jn :pi;oauctipn of corresppiding c to be..exported as .alsothe/ihcremehtaFefficiericies exj^ctedio ap^ an exercise is relevantin .p|ti^'to'\;cheGk iypidibfe -.royeh.u^^quahdtief of corTesppfînd to the disadvantage of localrhanu'factufers'of releyantihpuis. ■ \ '! • •

7) This issues v/ith the approval of competent authority

»! "il ,

Directorate General of Foreign Trade,De'"'2rtmen[ of Goiîmerce(Shri Nirmal Kumar, Dy DGFT),Uo'vog Bhawan. Now DelhiFI'Tiai 1! nirmal.kLtn"]arS5{'"7;i"iio.i11

("Barnalt Khastgir)Under Secretary to the Government of India

Phone; :23323292Email:[email protected]

)ii

|ltd.,dgftcom.nic.in/exim/2000/committee/meet_adv4_0318.pdf · 2017-11-02 · pharmaceuticals...

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