IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2015-11-27

DGFT Committee Minutes

Document text

Office of Directorate General of Foreign Trade
New Delhi -0

Para 4.7 Decision

Meeting No. 13/82/2015 of 2015-16, to consider the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products
and falling under Chapter 29 and 30, was scheduled for 27.11.2015 but actually held on 04.12.2015 under the Chairmanship of Dr. S.K. Bansal, Jt. DGFT in Room No.11, Udyog Bhawan, New Delhi.

Following members were present:-

Shri Nirmal Kumar, Dy.DGFT Shri A.K. Aggarwal, Addl. Indl. Advisor, DC&PC Shri D.N. Mathur, Consultant, Department of Pharmaceutical
Shri Mahendra Vikram Singh, Foreign Trade Development Officer

The committee went through the minutes of earlier NC –III meeting No. 12/82 was scheduled for 18.11.2015 but actually held on 23.11.2015 and approved the same.

Note:

In certain cases the decision of the Norms Committee refers to the Recommendations/ Observations / Deficiencies received from the concerned Technical authority in the same case or a different case of another firm with the same product. A scanned copy of such document is placed at the end of the Minutes. In some cases, the scanned copy uploaded may be unsigned. In both these instances, the scanned copy uploaded is to be accepted. The U.O.No. / O.M. No. of the scanned copy is reflected in the minutes.

MEETING NUMBER
: 13/82-ALC4/2015 MEETING DATE : 27.11.2015

1

Case No.:36/19/82-

ALC4/2014
Party Name:ALKALI METALS LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01524/AM15/
RLA File :09/24/040/00503/AM12/
Lic.No/Date:0910052125 12.04.2012 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DC&PC(Chemical).

2

Case No.:38/19/82-

ALC4/2014
Party Name:PORUS LABORATORIES PVT LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01526/AM15/
RLA File :09/24/040/00050/AM13/
Lic.No/Date:0910052706 21.05.2012 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DC&PC(Chemical).

3

Case No.:18/19/82-

ALC4/2014
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01506/AM15/
RLA File :09/24/040/00085/AM13/
Lic.No/Date:0910052887 05.06.2012 Defer Date: 30.12.2015

Decision : Reply receved from the firm and sent to DOP. It was decided to defer the case for want of comment of DOP.

4

Case No.:33/20/82-

ALC4/2013
Party Name:CADILA HEALTHCARE LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01019/AM14/
RLA File :08/24/040/00097/AM13/
Lic.No/Date:0810112515 14.06.2012 Defer Date: 30.12.2015 Decision : The Committee decided to defer the case for want of comments of DoP.

5

Case No.:4/4/82-

ALC4/2013
Party Name:SABERO ORGANICS GUJARAT LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00045/AM14/
RLA File :03/95/040/00880/AM13/
Lic.No/Date:0310724136 14.02.2013 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DC&PC(Chemical).

6

Case No.:46/13/82-

ALC4/2015
Party Name:DEEPAK NITRITE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01009/AM16/
RLA File :34/24/040/00241/AM13/
Lic.No/Date:3410036142 15.02.2013 Defer Date: Decision : The Committee decided to defer the case for want of comments of DCPC.

7

Case No.:79/1/82-

ALC4/2013
Party Name:STERICAT GUTSTRINGS PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01437/AM13/
RLA File :05/24/040/00420/AM13/
Lic.No/Date:0510346353 18.02.2013 Defer Date: 30.12.2015 Decision:The Committee decided to defer the case for want of comments of DCPC (Petrochemical).

8

Case No.:71/13/82-

ALC4/2015
Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01034/AM16/
RLA File :07/24/040/00494/AM13/
Lic.No/Date:0710093995 01.03.2013 Defer Date: Decision : The Committee decided to ratify norms for the export product based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/434/2015-FPI)Norms) dated 13.10.2015 , uploaded along with 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.

9

Case No.:20/7/82-

ALC4/2014
Party Name:DR REDDYS Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Rejected HQ File :01/82/050/00664/AM15/
RLA File :09/24/040/00041/AM14/
Lic.No/Date:0910056000 15.05.2013 Defer Date: Decision : The Committee noted that information has been called for from the firm by NC in its

meeting No.4/82 dated 12.6.2015 but reply has not been received so far. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC.

10

Case No.:173/5/82-

ALC4/2015
Party Name:FORACE POLYMERS (P) LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00313/AM16/
RLA File :05/23/040/00069/AM14/
Lic.No/Date:0510356983 13.06.2013 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DC&PC(chemical).

11

Case No.:35/26/83-

ALC1/2013
Party Name:PIRAMAL ENTERPRISES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/83/050/00358/AM14/
RLA File :03/95/040/00934/AM13/
Lic.No/Date:0310742480 23.07.2013 Defer Date: recommendation of DCPC forwarded vide U.O.No.14010/70/2015-CH-II dated 02.12.2015 , uploaded along with 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.

12

Case No.:1/10/82-

ALC4/2013
Party Name:MICRO LABS LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00184/AM14/
RLA File :07/24/040/00111/AM14/
Lic.No/Date:0710097180 30.07.2013 Defer Date:
recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/303/2015-FPI)Norms) dated November 2015 , uploaded along with 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.

13

Case No.:31/4/82-

ALC4/2014
Party Name:UNIVERSAL BIOFUELS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00279/AM15/
RLA File :09/24/040/00155/AM14/
Lic.No/Date:0910056959 31.07.2013 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DC&PC(Chemical).

14

Case No.:9/30/83-

ALC1/2013
Party Name:STERICON PHARMA PVT.LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/83/050/00471/AM14/
RLA File :07/24/040/00152/AM14/
Lic.No/Date:0710097668 22.08.2013 Defer Date:30.12.2015

15

Case No.:17/4/82-

ALC4/2015
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File RLA File Lic.No/Date:0510364363 Defer

:01/82/050/00056/AM16/
:05/23/040/00211/AM14/
04.09.2013 Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DC&PC(Chemical).

16

Case No.:36/19/82-

ALC4/2013
Party Name:SOHAM ORGANICS PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Rejected HQ File :01/82/050/00981/AM14/
RLA File :31/83/040/00124/AM14/
Lic.No/Date:3110060943 29.10.2013 Defer Date:
meeting No.7/82 dated 24.7.2015 but reply has not been received so far. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC.

17

Case No.:45/13/82-

ALC4/2015
Party Name:ATUL LIMITED, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01008/AM16/
RLA File :08/24/040/00335/AM14/
Lic.No/Date:0810126312 07.11.2013 Defer Date: recommendation of DCPC forwarded vide U.O.No.14010/16/2015-CH-II dated 10.11.2015 ,

18

Case No.:140/23/82-

ALC4/2013
Party Name:UNITED PHOSPHORUS LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01187/AM14/
RLA File :03/95/040/00495/AM14/
Lic.No/Date:0310758627 21.11.2013 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DC&PC(Chemicals)

19

Case No.:70/13/82-

ALC4/2015
Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01033/AM16/
RLA File :07/24/040/00327/AM14/
Lic.No/Date:0710100905 30.12.2013 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/434/2015-FPI)Norms) dated 13.10.2015 , uploaded along with these minutes or as applied by the firm whichever is less

20

Case No.:192/3/82-

ALC4/2014
Party Name:VIVIMED LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00196/AM15/
RLA File :09/24/040/00513/AM14/
Lic.No/Date:0910058896 10.01.2014 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DC&PC(Chemicals).

21 Case No.:48/13/82- ALC4/2015
Party Name:BELCHEM INDS. INDIA PVT. LTD. Meet No/Date:13/82- ALC4/2015 Status:Case Deferred

27.11.2015 HQ File :01/82/050/01011/AM16/
RLA File :03/94/040/00860/AM14/
Lic.No/Date:0310766718 17.01.2014 Defer Date:30.12.2015 DC&PC(Chemicals).

22

Case No.:208/3/82-

ALC4/2014
Party Name:OGENE SYSTEMS INDIA PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00212/AM15/
RLA File :09/24/040/00515/AM14/
Lic.No/Date:0910059017 22.01.2014 Defer Date:30.12.2015 Decision : The Committee based on the written comments forwarded by the D/o C&PC, vide U.O.No.14010/97/2012-Ch-II dated 11.08.2015, uploaded along with these minutes decided to call for information from the firm and deferred the case.

23

Case No.:12/21/82-

ALC4/2013
Party Name:KUDOS CHEMIE LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Rejected HQ File :01/82/050/01042/AM14/
RLA File :22/21/040/00096/AM14/
Lic.No/Date:2210014544 23.01.2014 Defer Date: meeting No.3/82 dated 20.05.2015. Inspite repeated reminders reply has not been received so far. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC.

24

Case No.:187/3/82-

ALC4/2014
Party Name:ALCHEM INTERNATIONAL LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Rejected HQ File :01/82/050/00191/AM15/
RLA File :05/23/040/00413/AM14/
Lic.No/Date:0510376990 24.01.2014 Defer Date: meeting No.16/82 dated 23.01.2015. Inspite repeated reminders reply has not been received so far. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC.

25

Case No.:108/3/82-

ALC4/2014
Party Name:CROPNOSYS (INDIA) PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00112/AM15/
RLA File :03/94/040/00908/AM14/
Lic.No/Date:0310767733 24.01.2014 Defer Date:30.12.2015

26

Case No.:44/4/82-

ALC4/2014
Party Name:CATAPHARMA CHEMICALS PVT. LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00292/AM15/
RLA File :31/83/040/00199/AM14/
Lic.No/Date:3110062387 30.01.2014 Defer Date: Decision : The import and export product is similar with the difference that export product

mentions ‘Pharma grade’ which does not justifies wastage more than 2%. Accordingly, the Committee decided to ratify norms with 2% wastage under Para 4.7 of HBP. RA concerned may take further necessary action as per decision of NC.

27

Case No.:177/3/82-

ALC4/2014
Party Name:INDO AMINES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00181/AM15/
RLA File :03/94/040/00958/AM14/
Lic.No/Date:0310768616 30.01.2014 Defer Date:30.12.2015 Decision : The Committee based on the written comments forwarded by the D/o C&PC, U.O.no.14010/81/2010-Ch-II dated 23.7.2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

28

Case No.:165/3/82-

ALC4/2014
Party Name:MANGALAM ORGANICS LIMITED. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00169/AM15/
RLA File :03/94/040/00448/AM14/
Lic.No/Date:0310768928 03.02.2014 Defer Date: recommendation of D/o C&PC forwarded vide U.O.No.14010/14/2015-Ch-II dated21.10.2015,

29

Case No.:45/19/82-

ALC4/2014
Party Name:MYLAN Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01533/AM15/
RLA File :09/24/040/00600/AM14/
Lic.No/Date:0910059428 26.02.2014 Defer Date: 14.01.2015
Decision: The Committee decided to defer the case for want of comments of DOP.

30

Case No.:58/6/82-

ALC4/2014
Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00460/AM15/
RLA File :03/94/040/00797/AM14/
Lic.No/Date:0310772503 28.02.2014 Defer Date:30.12.2015

31

Case No.:106/3/82-

ALC4/2014
Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00110/AM15/
RLA File :03/95/040/00960/AM14/
Lic.No/Date:0310772411 28.02.2014 Defer Date:30.12.2015

32

Case No.:46/6/82-

ALC4/2014
Party Name:NAPROD LIFE SCIENCES PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Rejected

HQ File :01/82/050/00448/AM15/
RLA File :03/95/040/00986/AM14/
Lic.No/Date:0310772962 04.03.2014 Defer Date:
meeting No.19/82 dated 18.03.2015 followed by reminders dated 20.05.2015 and 24.7.2015 reply has not been received so far. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC.

33

Case No.:34/6/82-

ALC4/2014
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00436/AM15/
RLA File :03/94/040/00973/AM14/
Lic.No/Date:0310773112 05.03.2014 Defer Date:30.12.2015

34

Case No.:58/4/82-

ALC4/2014
Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00306/AM15/
RLA File :22/24/040/00100/AM14/
Lic.No/Date:2210014694 14.03.2014 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DoP.

35

Case No.:57/3/82-

ALC4/2014
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00061/AM15/
RLA File :05/23/040/00506/AM14/
Lic.No/Date:0510382053 18.03.2014 Defer Date:30.12.2015

36

Case No.:51/5/82-

ALC4/2014
Party Name:JINDAL DRUGS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00368/AM15/
RLA File :03/94/040/01098/AM14/
Lic.No/Date:0310776087 27.03.2014 Defer Date:30.12.2015 Decision : The Committee based on the written comments forwarded by the D/o C&PC, U.O.no.14010/106/2011-Ch-II dated 02.12.2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

37

Case No.:127/6/82-

ALC4/2014
Party Name:CATAPHARMA CHEMICALS PVT. LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00529/AM15/
RLA File :31/83/040/00232/AM14/
Lic.No/Date:3110063312 28.03.2014 Defer Date: Decision : The import and export product is similar with the difference that export product mentions ‘Pharma grade’ which does not justifies wastage more than 2%. Accordingly, the Committee decided to ratify norms with 2% wastage under Para 4.7 of HBP. RA concerned may take further necessary action as per decision of NC.

38

Case No.:51/6/82-

ALC4/2014
Party Name:PERFECT INDUSTRIES PRIVATE LIMITED. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred

HQ File :01/82/050/00453/AM15/
RLA File :03/95/040/01054/AM14/
Lic.No/Date:0310776759 02.04.2014 Defer Date:30.12.2015 DC&PC(Chemicals).

39

Case No.:50/6/82-

ALC4/2014
Party Name:V & V PHARMA INDUSTRIES Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00452/AM15/
RLA File :03/95/040/01061/AM14/
Lic.No/Date:0310776760 02.04.2014 Defer Date:30.12.2015 DC&PC(Chemicals).

40

Case No.:92/8/82-

ALC4/2015
Party Name:YASHASHVI RASAYAN PVT.LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00888/AM16/
RLA File :52/24/040/00055/AM14/
Lic.No/Date:5210040903 02.04.2014 Defer Date: Decision : Already approved in 10/82/AM-16 dated 15.10.2015. Therefore, it was decided to withdraw the case.

41

Case No.:22/10/82-

ALC4/2014
Party Name:OGENE SYSTEMS INDIA PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Rejected HQ File :01/82/050/00936/AM15/
RLA File :09/24/040/00669/AM14/
Lic.No/Date:0910059697 03.04.2014 Defer Date: meeting No.7/82 dated 24.7.2015. Inspite repeated reminders reply has not been received so far. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC.

42

Case No.:20/6/82-

ALC4/2014
Party Name:ADISHANK CHEMICALS PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00422/AM15/
RLA File :03/94/040/01140/AM14/
Lic.No/Date:0310777786 09.04.2014 Defer Date:30.12.2015 DC&PC(Chemicals).

43

Case No.:1/2/82-

ALC4/2014
Party Name:CADILA HEALTHCARE LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00003/AM15/
RLA File :08/24/040/00008/AM15/
Lic.No/Date:0810130534 11.04.2014 Defer Date:30.12.2015

44

Case No.:32/5/82-

ALC4/2014
Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File RLA File Lic.No/Date:3110063481 Defer

:01/82/050/00349/AM15/
:31/83/040/00008/AM15/
11.04.2014 Date:30.12.2015 Decision : The Committee noted that information called for is awaited. Accordingly, it was decided to await the reply and deferred the case.

45

Case No.:34/5/82-

ALC4/2014
Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Rejected HQ File :01/82/050/00351/AM15/
RLA File :34/24/040/00003/AM15/
Lic.No/Date:3410039800 15.04.2014 Defer Date:
meeting No.4/82 dated 12.6.2015. Inspite repeated reminders reply has not been received so far. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC.

46

Case No.:48/10/82-

ALC4/2014
Party Name:MYLAN Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Rejected HQ File :01/82/050/00962/AM15/
RLA File :09/24/040/00650/AM14/
Lic.No/Date:0910059803 22.04.2014 Defer Date: meeting No.2/82 dated 29.04.2015. Inspite repeated reminders reply has not been received so far. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC.

47

Case No.:49/13/82-

ALC4/2015
Party Name:BELCHEM INDS. INDIA PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01012/AM16/
RLA File :03/94/040/01118/AM14/
Lic.No/Date:0310779215 23.04.2014 Defer Date:30.12.2015

48

Case No.:183/6/82-

ALC4/2014
Party Name:TIDE INDUSTRIES Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00585/AM15/
RLA File :34/24/040/00005/AM15/
Lic.No/Date:3410039854 23.04.2014 Defer Date:30.12.2015 Decision : The Committee based on the written comments forwarded by the D/o C&PC,
U.O.no.14010/40/2011-Ch-II dated 28.7.2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

49

Case No.:53/5/82-

ALC4/2014
Party Name:UNIMAX CHEMICALS PVT LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00370/AM15/
RLA File :03/95/040/00015/AM15/
Lic.No/Date:0310779156 23.04.2014 Defer Date: Decision : Already approved in meeting no.12/82/AM-16 dated 18.11.2015. Accordingly, it was decided to withdraw the case.

50 Case No.:6/5/82- ALC4/2014
Party Name:UNITED BIOTECH PVT.LTD. Meet No/Date:13/82- ALC4/2015 Status:Case Rejected

27.11.2015 HQ File :01/82/050/00323/AM15/
RLA File :05/24/040/00034/AM15/
Lic.No/Date:0510384810 24.04.2014 Defer Date:
meeting No.4/82 dated 12.6.2015. Inspite repeated reminders reply has not been received so far. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC.

51

Case No.:64/5/82-

ALC4/2014
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00381/AM15/
RLA File :03/95/040/00026/AM15/
Lic.No/Date:0310779504 25.04.2014 Defer Date: recommendation of D/o C&PC, forwarded vide U.O.no.14010/62/2010-Ch-II dated 02.12.2015 ,

52

Case No.:41/10/82-

ALC4/2014
Party Name:VIVIMED LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Rejected HQ File :01/82/050/00955/AM15/
RLA File :09/24/040/00028/AM15/
Lic.No/Date:0910059852 25.04.2014 Defer Date:
meeting No.2/82 dated 29.4.2015 followed by reminders dated 12.6.2015, 24.7.2015 and 30.09.2015 reply has not been received so far. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC.

53

Case No.:46/10/82-

ALC4/2014
Party Name:VIVIMED LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Rejected HQ File :01/82/050/00960/AM15/
RLA File :09/24/040/00029/AM15/
Lic.No/Date:0910059853 25.04.2014 Defer Date:
meeting No.2/82 dated 29.4.2015 followed by reminders dated 12.6.2015, 24.7.2015 and 30.09.2015 reply has not been received so far. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC.

54

Case No.:51/10/82-

ALC4/2014
Party Name:VIVIMED LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00965/AM15/
RLA File :09/24/040/00039/AM15/
Lic.No/Date:0910059887 28.04.2014 Defer Date:30.12.2015 DC&PC(Chemicals).

55 Case No.:61/10/82- ALC4/2014
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:13/82- ALC4/2015 Status:Case Deferred

27.11.2015 HQ File :01/82/050/00975/AM15/
RLA File :03/95/040/00913/AM14/
Lic.No/Date:0310779831 29.04.2014 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DC&PC(Chemicals/

56

Case No.:237/6/82-

ALC4/2014
Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00639/AM15/
RLA File :17/24/040/00002/AM15/
Lic.No/Date:1710005803 05.05.2014 Defer Date: 30.12.2015 DC&PC(Petrochemicals)

57

Case No.:39/5/82-

ALC4/2014
Party Name:INTAS PHARMACEUTICALS LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00356/AM15/
RLA File :08/24/040/00048/AM15/
Lic.No/Date:0810131081 05.05.2014 Defer Date: Decision : The Committee decided to defer the case for want of comments of DOP.

58

Case No.:54/5/82-

ALC4/2014
Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00371/AM15/
RLA File :03/95/040/00077/AM15/
Lic.No/Date:0310780621 05.05.2014 Defer Date:14.01.2015 Decision : The Committee decided to defer the case for want of comments of DCPC.

59

Case No.:383/5/82-

ALC4/2015
Party Name:DR REDDYS Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00523/AM16/
RLA File :09/24/040/00019/AM15/
Lic.No/Date:0910060081 13.05.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/473/2015-PI(Norms) dated 24.11.2015 uploaded along with these minutes or as applied by the firm whichever is less

60

Case No.:44/10/82-

ALC4/2014
Party Name:MYLAN Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Rejected HQ File :01/82/050/00958/AM15/
RLA File :09/24/040/00053/AM15/
Lic.No/Date:0910060088 13.05.2014 Defer Date:
meeting No.4/82 dated 12.6.2015 followed by reminder dated 24.7.2015 reply has not been received so far. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC.

61

Case No.:59/10/82-

ALC4/2014
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Rejected

HQ File :01/82/050/00973/AM15/
RLA File :09/24/040/00045/AM15/
Lic.No/Date:0910060084 13.05.2014 Defer Date:
meeting No.2/82 dated 29.4.2015 followed by reminder dated 12.06.2015 but reply has not been received so far. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC.

62

Case No.:44/13/82-

ALC4/2015
Party Name:ATUL BIOSCIENCE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01007/AM16/
RLA File :52/24/040/00004/AM15/
Lic.No/Date:5210041063 23.05.2014 Defer Date:30.12.2015

63

Case No.:13/2/82-

ALC4/2015
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00028/AM16/
RLA File :05/23/040/00080/AM15/
Lic.No/Date:0510387607 28.05.2014 Defer Date:30.12.2015

64

Case No.:38/8/82-

ALC4/2014
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00702/AM15/
RLA File :09/24/040/00108/AM15/
Lic.No/Date:0910060258 28.05.2014 Defer Date:30.12.2015

65

Case No.:51/8/82-

ALC4/2014
Party Name:PVS LABORATORIES LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Rejected HQ File :01/82/050/00715/AM15/
RLA File :09/24/040/00022/AM15/
Lic.No/Date:0910060267 28.05.2014 Defer Date:
meeting No.4/82 dated 12.06.2015. Inspite repeated reminders reply has not been received so far. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC.

66

Case No.:165/6/82-

ALC4/2014
Party Name:HALDIA PETROCHEMICALS LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00567/AM15/
RLA File :02/24/040/00037/AM15/
Lic.No/Date:0210203844 05.06.2014 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DCPC (Chemical).

67

Case No.:106/8/82-

ALC4/2014
Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00770/AM15/
RLA File :03/94/040/00131/AM15/
Lic.No/Date:0310785223 12.06.2014 Defer Date:30.12.2015

Decision : The Committee decided to defer the case for want of comments of DCPC (Chemical).

68

Case No.:60/10/82-

ALC4/2014
Party Name:BIO-TECH OPHTHALMICS PVT. LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00974/AM15/
RLA File :08/24/040/00116/AM15/
Lic.No/Date:0810132332 13.06.2014 Defer Date:30.12.2015 Decision : The Committee noted that information called for from the firm is awaited. The Committee accordingly decided await the reply and deferred the case.

69

Case No.:364/5/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00504/AM16/
RLA File :09/24/040/00124/AM15/
Lic.No/Date:0910060469 17.06.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/276/2015-PI(Norms) dated Sept. 2015 uploaded along with these minutes or as applied by the firm whichever is less

70

Case No.:77/8/82-

ALC4/2014
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00741/AM15/
RLA File :03/94/040/00196/AM15/
Lic.No/Date:0310785501 17.06.2014 Defer Date:30.12.2015

71

Case No.:20/8/82-

ALC4/2014
Party Name:SRINI PHARMACEUTICALS LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00684/AM15/
RLA File :09/24/040/00139/AM15/
Lic.No/Date:0910060467 17.06.2014 Defer Date:30.12.2015

72

Case No.:19/8/82-

ALC4/2014
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case deferred HQ File :01/82/050/00683/AM15/
RLA File :09/24/040/00153/AM15/
Lic.No/Date:0910060486 18.06.2014 Defer Date30.12.2013 Decision : The Committee noted that information has been called for from firm is awaited. The Committee deferred the case.

73

Case No.:52/8/82-

ALC4/2014
Party Name:LAKE CHEMICALS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00716/AM15/
RLA File :07/24/040/00096/AM15/
Lic.No/Date:0710105418 26.06.2014 Defer Date:30.12.2015

74

Case No.:63/10/82-

ALC4/2014
Party Name:SAVVY CARE & COSMETICS PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Rejected
HQ File :01/82/050/00977/AM15/
RLA File :03/95/040/00254/AM15/
Lic.No/Date:0310786114 27.06.2014 Defer Date:
meeting No.4/82 dated 12.6.2015. Inspite repeated reminders reply has not been received so far. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC

75

Case No.:199/6/82-

ALC4/2014
Party Name:H.J.AROCHEM PVT. LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Rejected HQ File :01/82/050/00601/AM15/
RLA File :08/24/040/00569/AM14/
Lic.No/Date:0810132520 30.06.2014 Defer Date: meeting No.7/82 dated 24.07.2015. Inspite repeated reminders reply has not been received so far. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC

76

Case No.:202/6/82-

ALC4/2014
Party Name:FORACE POLYMERS (P) LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00604/AM15/
RLA File :05/23/040/00139/AM15/
Lic.No/Date:0510389232 01.07.2014 Defer Date:30.12.2015

77

Case No.:83/8/82-

ALC4/2014
Party Name:MANGALAM ORGANICS LIMITED (FORMERLY DUJODWALA Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00747/AM15/
RLA File :03/95/040/00109/AM15/
Lic.No/Date:0310786418 04.07.2014 Defer Date: recommendation of D/o C&PC forwarded vide U.O.No.14010/14/2015-Ch-II dated21.10.2015,

78

Case No.:62/10/82-

ALC4/2014
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case
Deferred HQ File :01/82/050/00976/AM15/
RLA File :03/95/040/00271/AM15/
Lic.No/Date:0310786523 08.07.2014 Defer Date30.12.2015:

79

Case No.:44/15/82-

ALC4/2014
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01331/AM15/
RLA File :09/24/040/00192/AM15/
Lic.No/Date:0910060635 09.07.2014 Defer Date:30.12.2015

80

Case No.:26/9/82-

ALC4/2014
Party Name:ALMELO PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00823/AM15/
RLA File :09/24/040/00188/AM15/
Lic.No/Date:0910060660 11.07.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/604/2015-PI(Norms) dated October, 2015 uploaded along with these minutes or as applied by the firm whichever is NC.

81

Case No.:375/5/82-

ALC4/2015
Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00515/AM16/
RLA File :22/24/040/00023/AM15/
Lic.No/Date:2210015018 12.07.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/284/2015-PI(Norms) dated October 2015 uploaded along with these minutes or as applied by the firm whichever is less

82

Case No.:365/5/82-

ALC4/2015
Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00505/AM16/
RLA File :22/24/040/00028/AM15/
Lic.No/Date:2210015020 15.07.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/283/2015-PI(Norms) dated October 2015 uploaded along with these minutes or as applied by the firm whichever is less

83

Case No.:200/6/82-

ALC4/2014
Party Name:PANACEA BIOTEC LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00602/AM15/
RLA File :05/24/040/00168/AM15/
Lic.No/Date:0510389734 16.07.2014 Defer Date: recommendation of DBT forwarded vide O.M. No.BT/IL/05/316/2010-PID dated 29.10.2015,

84

Case No.:72/10/82-

ALC4/2014
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00986/AM15/
RLA File :07/24/040/00112/AM15/
Lic.No/Date:0710105884 18.07.2014 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DCPC(Chemicals)

85

Case No.:25/15/82-

ALC4/2014
Party Name:SHIVAM OILS & PROTEINS INDUSTRY, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred

HQ File :01/82/050/01312/AM15/
RLA File :56/24/040/00019/AM15/
Lic.No/Date:5610004338 22.07.2014 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DCPC(Chemicals)

86

Case No.:71/8/82-

ALC4/2014
Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Rejected HQ File :01/82/050/00735/AM15/
RLA File :34/24/040/00099/AM15/
Lic.No/Date:3410040394 23.07.2014 Defer Date:
meeting No.18/82 dated 18,2.2015 followed by reminders dated 29.4.2015, 12.6.2015 and 24.7.2015 reply has not been received so far. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC.

87

Case No.:66/8/82-

ALC4/2014
Party Name:RECKITT BENCKISER HEALTHCARE INDIA LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Rejected HQ File :01/82/050/00730/AM15/
RLA File :05/24/040/00205/AM15/
Lic.No/Date:0510390158 06.08.2014 Defer Date:
meeting No.18/82 dated 18,2.2015 followed by reminders dated 29.4.2015 and 12.6.2015 reply has not been received so far. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC.

88

Case No.:42/13/82-

ALC4/2014
Party Name:INCHEM LABORATORIES PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01045/AM15/
RLA File :09/24/040/00242/AM15/
Lic.No/Date:0910060833 07.08.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/105/2015-PI(Norms) dated October 2015 uploaded along with these minutes or as applied by the firm whichever is less

89

Case No.:53/9/82-

ALC4/2014
Party Name:ONEIRO CHEMICALS LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00850/AM15/
RLA File :34/24/040/00111/AM15/
Lic.No/Date:3410040436 11.08.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/282/2015-PI(Norms) dated October 2015 uploaded along with these minutes or as applied by the firm whichever is less

90

Case No.:8/9/82-

ALC4/2014
Party Name:RANBAXY LABORATORIES LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00805/AM15/
RLA File :05/24/040/00202/AM15/
Lic.No/Date:0510390250 11.08.2014 Defer Date:

recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/252/2015-PI(Norms) dated October 2015 uploaded along with these minutes or as applied by the firm whichever is less

91

Case No.:93/9/82-

ALC4/2014
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00890/AM15/
RLA File :03/95/040/00412/AM15/
Lic.No/Date:0310787910 11.08.2014 Defer Date: recommendation of D/o C&PC forwarded vide U.O.No.14010/95/2011-Ch-II dated 20th October 2015 uploaded along with 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.

92

Case No.:21/9/82-

ALC4/2014
Party Name:PI INDUSTRIES LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00818/AM15/
RLA File :13/24/040/00020/AM15/
Lic.No/Date:1310047575 12.08.2014 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DC&PC(Chemicals

93

Case No.:211/13/82-

ALC4/2014
Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01214/AM15/
RLA File :03/94/040/00423/AM15/
Lic.No/Date:0310788032 14.08.2014 Defer Date: recommendation of D/o C&PC, forwarded vide U.O.No.14010/67/2011-CH-II dated 30.9.2015,

94

Case No.:60/13/82-

ALC4/2014
Party Name:VERDANT LIFE SCIENCES PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01063/AM15/
RLA File :09/24/040/00238/AM15/
Lic.No/Date:0910060869 20.08.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/176/2015-PI(Norms) dated October 2015 uploaded along with these minutes or as applied by the firm whichever is less

95

Case No.:229/13/82-

ALC4/2014
Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01232/AM15/
RLA File :03/94/040/00465/AM15/
Lic.No/Date:0310788333 25.08.2014 Defer Date: recommendation of D/o C&PC forwarded vide U.O.No.14010/67/2011-Ch-II dated 30.09.2015

96

Case No.:17/15/82-

ALC4/2014
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01304/AM15/
RLA File :03/95/040/00428/AM15/
Lic.No/Date:0310788314 25.08.2014 Defer Date: recommendation of D/o C&PC, forwarded vide U.O.no.14010/62/2010-Ch-II dated 02.12.2015 ,

97

Case No.:37/7/82-

ALC4/2015
Party Name:DR J PHARMACHEM (INDIA)(PROP.ADITYA PRAMOD JOGDEO) Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00642/AM16/
RLA File :31/83/040/00125/AM15/
Lic.No/Date:3110064792 28.08.2014 Defer Date:30.12.2015 Decision : The Committee decided noted that information called for from the firm is awaited. The Committee accordingly deferred the case.

98

Case No.:254/13/82-

ALC4/2014
Party Name:SEQUENT SCIENTIFIC LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01257/AM15/
RLA File :03/95/040/00459/AM15/
Lic.No/Date:0310788513 28.08.2014 Defer Date:30.12.2015 Committee accordingly deferred the case.

99

Case No.:217/13/82-

ALC4/2014
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01220/AM15/
RLA File :03/94/040/00494/AM15/
Lic.No/Date:0310788620 02.09.2014 Defer Date:30.12.2015 Committee accordingly deferred the case.

100

Case No.:401/5/82-

ALC4/2015
Party Name:ONEIRO CHEMICALS LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00541/AM16/
RLA File :34/24/040/00141/AM15/
Lic.No/Date:3410040510 04.09.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/282/2015-PI(Norms) dated October 2015 uploaded along with these minutes or as applied by the firm whichever is NC.

101

Case No.:22/13/82-

ALC4/2014
Party Name:MANGALAM ORGANICS LIMITED (FORMERLY DUJODWALA Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File RLA File Lic.No/Date:0310788810 Defer

:01/82/050/01025/AM15/ :03/95/040/00379/AM15/ 05.09.2014 Date:30.12.2015

102

Case No.:196/13/82-

ALC4/2014
Party Name:KOPRAN LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Rejected HQ File :01/82/050/01199/AM15/
RLA File :03/94/040/00545/AM15/
Lic.No/Date:0310788934 09.09.2014 Defer Date: meeting No.7/82 dated 24.7.2015 followed by reminder dated 30.09.2015 reply has not been received so far. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC.

103

Case No.:201/13/82-

ALC4/2014
Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01204/AM15/
RLA File :03/94/040/00499/AM15/
Lic.No/Date:0310788928 09.09.2014 Defer Date: recommendation of D/o C&PC forwarded vide U.O.No.14010/100/2012-Ch-II dated 10.11.2015

104

Case No.:27/13/82-

ALC4/2014
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01030/AM15/
RLA File :03/95/040/00494/AM15/
Lic.No/Date:0310788943 09.09.2014 Defer Date: recommendation of D/o C&PC forwarded vide U.O.No.14010/64/2013-Ch-II dated 15.04.2015

105

Case No.:23/13/82-

ALC4/2014
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01026/AM15/
RLA File :03/95/040/00496/AM15/
Lic.No/Date:0310788911 09.09.2014 Defer Date: recommendation of D/o C&PC forwarded vide U.O.No.14010/95/2011-Ch-II dated 20.10.2015

106

Case No.:250/13/82-

ALC4/2014
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status: Case Approved HQ File :01/82/050/01253/AM15/
RLA File :03/95/040/00490/AM15/
Lic.No/Date:0310788892 09.09.2014 Defer Date: recommendation of D/o C&PC forwarded vide U.O.No.14010/95/2011-Ch-II dated 30.04.2015

107

Case No.:71/13/82-

ALC4/2014
Party Name:INCHEM LABORATORIES PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01074/AM15/
RLA File :09/24/040/00313/AM15/
Lic.No/Date:0910060931 10.09.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/105/2015-PI(Norms) dated October 2015 uploaded along with these minutes or as applied by the firm whichever is NC.

108

Case No.:53/13/82-

ALC4/2014
Party Name:MYLAN Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Rejected HQ File :01/82/050/01056/AM15/
RLA File :09/24/040/00240/AM15/
Lic.No/Date:0910060930 10.09.2014 Defer Date: meeting No.7/82 dated 24.7.2015 followed by reminder dated 30.09.2015 reply has not been received so far. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC.

109

Case No.:197/13/82-

ALC4/2014
Party Name:KOPRAN LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Rejected HQ File :01/82/050/01200/AM15/
RLA File :03/94/040/00547/AM15/
Lic.No/Date:0310789054 11.09.2014 Defer Date: meeting No.7/82 dated 24.7.2015 followed by reminder dated 30.09.2015 reply has not been received so far. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC.

110

Case No.:4/8/82-

ALC4/2014
Party Name:HONOUR LAB LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00668/AM15/
RLA File :09/24/040/00318/AM15/
Lic.No/Date:0910060963 12.09.2014 Defer Date:
30.12.2015 Decision : Requisite information has been received and send to DoP on 10.12.2015. The Committee decided to defer the case for want of comments from DoP.

111

Case No.:6/8/82-

ALC4/2014
Party Name:HONOUR LAB LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00670/AM15/
RLA File :09/24/040/00314/AM15/
Lic.No/Date:0910060964 12.09.2014 Defer Date: 30.12.2015 Decision : Requisite information has been received and send to DoP on 10.12.2015. The Committee decided to defer the case for want of comments from DoP.

112 Case No.:8/8/82- Party Name:HONOUR LAB Meet No/Date:13/82- Status :

ALC4/2014
LIMITED ALC4/2015 27.11.2015 Case deferred HQ File :01/82/050/00672/AM15/
RLA File :09/24/040/00315/AM15/
Lic.No/Date:0910060966 12.09.2014 Defer Date: 30.12.2015 Decision : Requisite information has been received and send to DoP on 10.12.2015. The Committee decided to defer the case for want of comments from DoP.

113

Case No.:28/13/82-

ALC4/2014
Party Name:TITAN LABORATORIES PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01031/AM15/
RLA File :03/95/040/00398/AM15/
Lic.No/Date:0310789099 12.09.2014 Defer Date:30.12.2015 Committee accordingly deferred the case.

114

Case No.:398/5/82-

ALC4/2015
Party Name:YASH RASAYAN & CHEMICALS Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Approved HQ File :01/82/050/00538/AM16/
RLA File :34/24/040/00122/AM15/
Lic.No/Date:3410040555 15.09.2014 Defer Date:
recommendation of D/o C&PC forwarded vide U.O.No.14010/42/2015-Ch-II dated 07.10.2015

115

Case No.:188/13/82-

ALC4/2014
Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01191/AM15/
RLA File :03/94/040/00102/AM15/
Lic.No/Date:0310789322 17.09.2014 Defer Date:30.12.2015 Committee accordingly deferred the case.

116

Case No.:57/13/82-

ALC4/2014
Party Name:HELLO PAINTS (P) LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01060/AM15/
RLA File :05/23/040/00277/AM15/
Lic.No/Date:0510391246 19.09.2014 Defer Date:30.12.2015 Decision : The Committee deferred the case for want of comments of DCPC(Chemicals).

117

Case No.:125/8/82-

ALC4/2014
Party Name:HETERO DRUGS LIMITED, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00789/AM15/
RLA File :09/24/040/00345/AM15/
Lic.No/Date:0910061000 19.09.2014 Defer Date:30.12.2015 Committee accordingly deferred the case.

118 Case No.:9/15/82- ALC4/2014
Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:13/82- ALC4/2015 Status:Case Deferred

27.11.2015 HQ File :01/82/050/01296/AM15/
RLA File :09/24/040/00327/AM15/
Lic.No/Date:0910061001 19.09.2014 Defer Date:30.12.2015 Decision : The Committee deferred the case for want of comments of DBT.

119

Case No.:60/15/82-

ALC4/2014
Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01347/AM15/
RLA File :31/83/040/00136/AM15/
Lic.No/Date:3110064915 22.09.2014 Defer Date:30.12.2015 Decision : The Committee based on the written comments forwarded by the D/o C&PC, U.O.No.14010/2/2012-Ch-II dated 21.07.2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

120

Case No.:128/8/82-

ALC4/2014
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00792/AM15/
RLA File :09/24/040/00341/AM15/
Lic.No/Date:0910061003 22.09.2014 Defer Date:30.12.2015 Committee accordingly deferred the case

121

Case No.:129/8/82-

ALC4/2014
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00793/AM15/
RLA File :09/24/040/00338/AM15/
Lic.No/Date:0910061004 22.09.2014 Defer Date:30.12.2015 Committee accordingly deferred the case

122

Case No.:17/13/82-

ALC4/2014
Party Name:GRASIM INDUSTRIES LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01020/AM15/
RLA File :34/24/040/00155/AM15/
Lic.No/Date:3410040570 23.09.2014 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of C&PC (Chemicals).

123

Case No.:376/5/82-

ALC4/2015
Party Name:R.K.INDUSTRIES, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00516/AM16/
RLA File :08/24/040/00231/AM15/
Lic.No/Date:0810133412 23.09.2014 Defer Date: DC&PC(Chemicals)

124

Case No.:115/13/82-

ALC4/2014
Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred

HQ File :01/82/050/01118/AM15/
RLA File :02/24/040/00097/AM15/
Lic.No/Date:0210205008 23.09.2014 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DCPC (Chemicals).

125

Case No.:74/13/82-

ALC4/2014
Party Name:CONSTECH ENTERPRISES PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01077/AM15/
RLA File :05/23/040/00282/AM15/
Lic.No/Date:0510391308 24.09.2014 Defer Date:30.12.2015 DC&PC(Chemicals)

126

Case No.:9/2/82-

ALC4/2015
Party Name:JUBILANT GENERICS LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00024/AM16/
RLA File :05/23/040/00261/AM15/
Lic.No/Date:0510391358 26.09.2014 Defer Date:30.12.2015

127

Case No.:21/13/82-

ALC4/2014
Party Name:JUBILANT GENERICS LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01024/AM15/
RLA File :05/23/040/00260/AM15/
Lic.No/Date:0510391357 26.09.2014 Defer Date:30.12.2015

128

Case No.:19/13/82-

ALC4/2014
Party Name:SANO MEDICAL KITS PVT. LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01022/AM15/
RLA File :04/24/040/00171/AM15/
Lic.No/Date:0410159504 29.09.2014 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DBT/DoP.

129

Case No.:177/13/82-

ALC4/2014
Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01180/AM15/
RLA File :03/94/040/00586/AM15/
Lic.No/Date:0310789849 30.09.2014 Defer Date:30.12.2015 DC&PC(Chemicals)

130

Case No.:15/13/82-

ALC4/2014
Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01018/AM15/
RLA File :34/24/040/00161/AM15/
Lic.No/Date:3410040594 30.09.2014 Defer Date:30.12.2015 DC&PC(Chemicals)

131

Case No.:29/18/82-

ALC4/2014
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01395/AM15/
RLA File :03/94/040/00596/AM15/
Lic.No/Date:0310789917 01.10.2014 Defer Date: recommendation of D/o C&PC U.O.No.14010/47/2014-Ch-II dated 10.11.2015, uploaded along with 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.

132

Case No.:19/1/82-

ALC4/2015
Party Name:GEM AROMATICS PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01545/AM15/
RLA File :03/94/040/00594/AM15/
Lic.No/Date:0310789922 01.10.2014 Defer Date:30.12.2015 DC&PC(Chemicals)

133

Case No.:77/13/82-

ALC4/2014
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01080/AM15/
RLA File :04/24/040/00164/AM15/
Lic.No/Date:0410159520 01.10.2014 Defer Date:30.12.2015

134

Case No.:160/13/82-

ALC4/2014
Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01163/AM15/
RLA File :03/94/040/00544/AM15/
Lic.No/Date:0310789976 07.10.2014 Defer Date:30.12.2015 DC&PC(Chemicals).

135

Case No.:176/13/82-

ALC4/2014
Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01179/AM15/
RLA File :03/94/040/00361/AM15/
Lic.No/Date:0310789985 07.10.2014 Defer Date:30.12.2015

136

Case No.:5/9/82-

ALC4/2014
Party Name:HETERO DRUGS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00802/AM15/
RLA File :09/24/040/00362/AM15/
Lic.No/Date:0910061060 07.10.2014 Defer Date:30.12.2015

137 Case No.:179/13/82- ALC4/2014
Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:13/82- ALC4/2015 Status:Case Approved

27.11.2015 HQ File :01/82/050/01182/AM15/
RLA File :03/94/040/00622/AM15/
Lic.No/Date:0310790000 08.10.2014 Defer Date: recommendation of D/o C&PC forwarded vide U.O.No.14010/67/2011-Ch-II dated 30.09.2015

138

Case No.:35/13/82-

ALC4/2014
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01038/AM15/
RLA File :05/23/040/00218/AM15/
Lic.No/Date:0510391491 08.10.2014 Defer Date:30.12.2015 DC&PC(Chemicals)

139

Case No.:76/13/82-

ALC4/2014
Party Name:CAPLIN POINT LABORATORIES LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01079/AM15/
RLA File :04/24/040/00163/AM15/
Lic.No/Date:0410159566 13.10.2014 Defer Date:30.12.2015 Decision : The Committee based on the written comments forwarded by the D/o C&PC, D/o Pharmaceuticals vide O.M.35011/624/2014-PI(Norms) dated 07.04.2015 , uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

140

Case No.:140/13/82-

ALC4/2014
Party Name:MICRO LABS LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01143/AM15/
RLA File :07/24/040/00228/AM15/
Lic.No/Date:0710106816 13.10.2014 Defer Date: Decision : Withdrawn. Case approved in NC 11/AM16.

141

Case No.:124/5/82-

ALC4/2015
Party Name:DORF-KETAL CHEMICALS INDIA PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00264/AM16/
RLA File :03/94/040/00684/AM15/
Lic.No/Date:0310790248 14.10.2014 Defer Date: recommendation of D/o C&PC, forwarded vide U.O.No.14010/176/2011-ch-II dated 20.10.2015,

142

Case No.:184/13/82-

ALC4/2014
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01187/AM15/
RLA File :03/94/040/00675/AM15/
Lic.No/Date:0310790237 14.10.2014 Defer Date:30.12.2015 Decision :The Committee noted that information called for from the firm is awaited. The

Committee decided to await the reply and deferred the case.

143

Case No.:272/13/82-

ALC4/2014
Party Name:SAIBABA SURFACTANTS (P) LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01275/AM15/
RLA File :08/24/040/00249/AM15/
Lic.No/Date:0810133587 14.10.2014 Defer Date: recommendation of D/o C&PC, forwarded vide U.O.No.14010/56/2013-Ch-II dated 30.11.2015,

144

Case No.:114/9/82-

ALC4/2014
Party Name:HONOUR LAB LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00911/AM15/
RLA File :09/24/040/00386/AM15/
Lic.No/Date:0910061094 15.10.2014 Defer Date:30.12.2015 Decision : Requisite information has been received and send to DoP. The Committee decided to defer the case for want of comments from DoP.

145

Case No.:42/15/82-

ALC4/2014
Party Name:PVS AGRO VET Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01329/AM15/
RLA File :09/24/040/00246/AM15/
Lic.No/Date:0910061105 16.10.2014 Defer Date:30.12.2015 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. No.35011/368/2015-PI(Norms) dated 27.11.2015 , uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

146

Case No.:154/13/82-

ALC4/2014
Party Name:GEM AROMATICS PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01157/AM15/
RLA File :03/94/040/00680/AM15/
Lic.No/Date:0310790351 17.10.2014 Defer Date:30.12.2015 DC&PC(Chemicals)

147

Case No.:124/13/82-

ALC4/2014
Party Name:PANACEA BIOTEC LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01127/AM15/
RLA File :05/24/040/00319/AM15/
Lic.No/Date:0510391623 17.10.2014 Defer Date: 14.01.2016 Decision : The Committee decided to defer the case for want of comments of DBT.

148

Case No.:384/5/82-

ALC4/2015
Party Name:SATYADEVA PHARMACEUTICALS /P/ LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved

HQ File :01/82/050/00524/AM16/
RLA File :09/24/040/00382/AM15/
Lic.No/Date:0910061123 20.10.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No. 35011/242/2015-PI(Norms) dated Sept. 2015, uploaded along with these minutes or as applied by the firm whichever is less

149

Case No.:125/5/82-

ALC4/2015
Party Name:DORF-KETAL CHEMICALS INDIA PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00265/AM16/
RLA File :03/94/040/00605/AM15/
Lic.No/Date:0310790441 21.10.2014 Defer Date: recommendation of D/o C&PC, forwarded vide U.O.No.14010/176/2011-Ch-II dated 20.10.2015,

150

Case No.:78/10/82-

ALC4/2014
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00992/AM15/
RLA File :09/24/040/00393/AM15/
Lic.No/Date:0910061130 22.10.2014 Defer Date:30.12.2015 Decision :Information called for from the firm is awaited. The Committee decided to await the reply and deferred the case.

151

Case No.:80/10/82-

ALC4/2014
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00994/AM15/
RLA File :09/24/040/00394/AM15/
Lic.No/Date:0910061132 22.10.2014 Defer Date:30.12.2015 Decision : Information called for from the firm is awaited. The Committee decided to await the

152

Case No.:81/10/82-

ALC4/2014
Party Name:HONOUR LAB LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00995/AM15/
RLA File :09/24/040/00407/AM15/
Lic.No/Date:0910061133 22.10.2014 Defer Date:30.12.2015 Decision : The Committee noted that information has been called for from the is awaited.. The Committee deferred the case.

153

Case No.:172/13/82-

ALC4/2014
Party Name:PRASOL CHEMICALS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01175/AM15/
RLA File :03/95/040/00362/AM15/
Lic.No/Date:0310790480 22.10.2014 Defer Date:30.12.2015 Decision : Information called for from the firm is awaited. The Committee decided to await the

154

Case No.:170/13/82-

ALC4/2014
Party Name:SAVLA CHEMICALS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01173/AM15/
RLA File :03/95/040/00619/AM15/
Lic.No/Date:0310790490 22.10.2014 Defer Date: recommendation of D/o C&PC, forwarded vide U.O.No.14010/71/2014-CH-II date 10.11.2015,

155

Case No.:110/13/82-

ALC4/2014
Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01113/AM15/
RLA File :34/24/040/00188/AM15/
Lic.No/Date:3410040635 22.10.2014 Defer Date:30.12.2015 DC&PC(Chemicals)

156

Case No.:83/10/82-

ALC4/2014
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00997/AM15/
RLA File :09/24/040/00402/AM15/
Lic.No/Date:0910061139 27.10.2014 Defer Date:30.12.2015

157

Case No.:87/13/82-

ALC4/2014
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01090/AM15/
RLA File :04/24/040/00196/AM15/
Lic.No/Date:0410159624 27.10.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/06/2015-PI(Norms) dated October 2015 , uploaded along with these minutes or as applied by the firm whichever is NC.

158

Case No.:276/13/82-

ALC4/2014
Party Name:INTAS PHARMACEUTICALS LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01279/AM15/
RLA File :08/24/040/00288/AM15/
Lic.No/Date:0810133688 28.10.2014 Defer Date: 14.01.2016

159

Case No.:387/5/82-

ALC4/2015
Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved

HQ File :01/82/050/00527/AM16/
RLA File :09/24/040/00412/AM15/
Lic.No/Date:0910061152 29.10.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No. No.35011/420/2015- PI(Norms) dated October 2015, uploaded along with 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.

160

Case No.:86/10/82-

ALC4/2014
Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01000/AM15/
RLA File :34/24/040/00194/AM15/
Lic.No/Date:3410040644 30.10.2014 Defer Date:30.12.2015 DC&PC(Chemicals).

161

Case No.:104/13/82-

ALC4/2014
Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01107/AM15/
RLA File :13/24/040/00029/AM15/
Lic.No/Date:1310047687 05.11.2014 Defer Date:30.12.2015

162

Case No.:266/13/82-

ALC4/2014
Party Name:ATUL LIMITED, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01269/AM15/
RLA File :08/24/040/00289/AM15/
Lic.No/Date:0810133735 05.11.2014 Defer Date:30.12.2015 DC&PC(Chemicals)

163

Case No.:268/13/82-

ALC4/2014
Party Name:ATUL LIMITED, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01271/AM15/
RLA File :08/24/040/00283/AM15/
Lic.No/Date:0810133734 05.11.2014 Defer Date:30.12.2015 DC&PC(Chemicals)

164

Case No.:39/7/82-

ALC4/2015
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00644/AM16/
RLA File :09/24/040/00371/AM15/
Lic.No/Date:0910061181 05.11.2014 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DoP

165

Case No.:107/13/82-

ALC4/2014
Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred

HQ File :01/82/050/01110/AM15/
RLA File :34/24/040/00196/AM15/
Lic.No/Date:3410040655 05.11.2014 Defer Date:30.12.2015 DC&PC(Chemicals)

166

Case No.:1/13/82-

ALC4/2014
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01004/AM15/
RLA File :09/24/040/00417/AM15/
Lic.No/Date:0910061188 07.11.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No. No.35011/406/2015- PI(Norms) dated 5th October 2015, uploaded along with 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.

167

Case No.:23/15/82-

ALC4/2014
Party Name:VENUS REMEDIES LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01310/AM15/
RLA File :22/24/040/00065/AM15/
Lic.No/Date:2210015115 07.11.2014 Defer Date:30.12.2015

168

Case No.:265/13/82-

ALC4/2014
Party Name:H.J.AROCHEM PVT. LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Rejected HQ File :01/82/050/01268/AM15/
RLA File :08/24/040/00265/AM15/
Lic.No/Date:0810133768 10.11.2014 Defer Date: meeting No.7/82 dated 24.7.2015. Inspite repeated reminders reply has not been received so far. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC.

169

Case No.:358/5/82-

ALC4/2015
Party Name:SHEETAL CHEMICALS PVT LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00498/AM16/
RLA File :09/24/040/00422/AM15/
Lic.No/Date:0910061196 10.11.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No. No.35011/286/2015- PI(Norms) dated October 2015, uploaded along with 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.

170

Case No.:114/13/82-

ALC4/2014
Party Name:VIRDEV INTERMEDIATES PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File RLA File Lic.No/Date:5210041292 Defer

:01/82/050/01117/AM15/ :52/24/040/00042/AM15/ 10.11.2014 Date:30.12.2015 Decision :Information called for from the firm is awaited. The Committee deferred the case.

171

Case No.:111/13/82-

ALC4/2014
Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01114/AM15/
RLA File :05/23/040/00352/AM15/
Lic.No/Date:0510391927 11.11.2014 Defer Date:30.12.2015 Decision : Information called for from the firm is awaited. The Committee deferred the case.

172

Case No.:19/15/82-

ALC4/2014
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01306/AM15/
RLA File :04/24/040/00206/AM15/
Lic.No/Date:0410159706 11.11.2014 Defer Date:30.12.2015

173

Case No.:20/15/82-

ALC4/2014
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01307/AM15/
RLA File :04/24/040/00207/AM15/
Lic.No/Date:0410159705 11.11.2014 Defer Date:30.12.2015

174

Case No.:61/18/82-

ALC4/2014
Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01427/AM15/
RLA File :34/24/040/00198/AM15/
Lic.No/Date:3410040676 11.11.2014 Defer Date:30.12.2015 (Chemicals)

175

Case No.:100/4/82-

ALC4/2015
Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00139/AM16/
RLA File :17/24/040/00125/AM15/
Lic.No/Date:1710005978 12.11.2014 Defer Date:30.12.2015 (Chemicals)

176

Case No.:120/13/82-

ALC4/2014
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01123/AM15/
RLA File :05/23/040/00325/AM15/
Lic.No/Date:0510391947 12.11.2014 Defer Date:30.12.2015 (Chemicals)

177

Case No.:98/18/82-

ALC4/2014
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01464/AM15/
RLA File :07/24/040/00272/AM15/
Lic.No/Date:0710106948 12.11.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No. No.35011/296/2015- PI(Norms) dated October 2015, uploaded along with 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.

178

Case No.:77/18/82-

ALC4/2014
Party Name:LAKELAND CHEMICALS (INDIA) LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01443/AM15/
RLA File :03/95/040/00629/AM14/
Lic.No/Date:0310790966 12.11.2014 Defer Date:30.12.2015 (Chemicals)

179

Case No.:65/18/82-

ALC4/2014
Party Name:DEEPAK NITRITE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01431/AM15/
RLA File :34/24/040/00199/AM15/
Lic.No/Date:3410040677 13.11.2014 Defer Date:30.12.2015 Decision : The Committee based on the written comments forwarded by the D/o C&PC, U.O.No.14010/36/2012-Ch-II dated 10.03.2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

180

Case No.:72/18/82-

ALC4/2014
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01438/AM15/
RLA File :03/94/040/00773/AM15/
Lic.No/Date:0310791044 13.11.2014 Defer Date:30.12.2015 Decision :Information called for from the firm is awaited. The committee accordingly deferred the case.

181

Case No.:42/18/82-

ALC4/2014
Party Name:LAKELAND CHEMICALS (INDIA) LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01408/AM15/
RLA File :03/95/040/00628/AM14/
Lic.No/Date:0310791049 13.11.2014 Defer Date:30.12.2015

182

Case No.:65/15/82-

ALC4/2014
Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File RLA File Lic.No/Date:0510392011 Defer

:01/82/050/01352/AM15/ :05/23/040/00360/AM15/ 14.11.2014 Date:30.12.2015 Decision : Information called for from the firm is awaited. The committee accordingly deferred the case.

183

Case No.:119/13/82-

ALC4/2014
Party Name:JUBILANT GENERICS LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01122/AM15/
RLA File :05/23/040/00304/AM15/
Lic.No/Date:0510392008 14.11.2014 Defer Date:30.12.2015 Decision : Information called for from the firm is awaited. The committee accordingly deferred the case.

184

Case No.:366/5/82-

ALC4/2015
Party Name:MYLAN Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00506/AM16/
RLA File :09/24/040/00424/AM15/
Lic.No/Date:0910061281 20.11.2014 Defer Date: Decision :withdrawn. Already approved in NC 10/AM16.

185

Case No.:52/15/82-

ALC4/2014
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01339/AM15/
RLA File :09/24/040/00408/AM15/
Lic.No/Date:0910061280 20.11.2014 Defer Date:30.12.2015 Decision : Information called for from the firm is awaited. The committee accordingly deferred the case.

186

Case No.:34/18/82-

ALC4/2014
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01400/AM15/
RLA File :03/94/040/00803/AM15/
Lic.No/Date:0310791303 21.11.2014 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DOP..

187

Case No.:16/18/82-

ALC4/2014
Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case
Deferred HQ File :01/82/050/01382/AM15/
RLA File :03/94/040/00789/AM15/
Lic.No/Date:0310791300 21.11.2014 Defer Date30.12.2015: DC&PC(Chemicals)

188

Case No.:371/5/82-

ALC4/2015
Party Name:MYLAN Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00511/AM16/
RLA File :09/24/040/00463/AM15/
Lic.No/Date:0910061295 24.11.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No. No.35011/423/2015-

PI(Norms) dated October 2015, uploaded along with 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.

189

Case No.:74/18/82-

ALC4/2014
Party Name:ADESHWAR MEDITEX PVT. LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01440/AM15/
RLA File :03/94/040/00814/AM15/
Lic.No/Date:0310791373 25.11.2014 Defer Date:30.12.2015 DC&PC(Chemicals).

190

Case No.:18/18/82-

ALC4/2014
Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01384/AM15/
RLA File :03/94/040/00792/AM15/
Lic.No/Date:0310791374 25.11.2014 Defer Date:30.12.2015 DC&PC(Chemicals)

191

Case No.:357/5/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00497/AM16/
RLA File :09/24/040/00435/AM15/
Lic.No/Date:0910061305 25.11.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No. No.35011/276/2015- PI(Norms) dated September 2015, uploaded along with 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.

192

Case No.:53/18/82-

ALC4/2014
Party Name:CATAPHARMA CHEMICALS PVT. LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01419/AM15/
RLA File :31/83/040/00057/AM15/
Lic.No/Date:3110065095 25.11.2014 Defer Date: Decision : The import and export product is similar with the difference that export product mentions ‘Pharma grade’ which does not justifies wastage more than 2%. Accordingly, the Committee decided to ratify norms with 2% wastage under Para 4.7 of HBP. RA concerned may take further necessary action as per decision of NC.

193

Case No.:367/5/82-

ALC4/2015
Party Name:MYLAN Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00507/AM16/
RLA File :09/24/040/00476/AM15/
Lic.No/Date:0910061308 25.11.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/421/2015-PI(Norms) dated October 2015 , uploaded along with these minutes or as applied by the firm whichever is

NC.

194

Case No.:15/2/82-

ALC4/2015
Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00030/AM16/
RLA File :03/95/040/00639/AM15/
Lic.No/Date:0310791416 25.11.2014 Defer Date:30.12.2015 DC&PC(Chemicals)

195

Case No.:99/13/82-

ALC4/2014
Party Name:HETERO DRUGS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01102/AM15/
RLA File :09/24/040/00472/AM15/
Lic.No/Date:0910061318 26.11.2014 Defer Date:
Decision : Withdrawn-Already approved in NC 09/AM16.

196

Case No.:43/18/82-

ALC4/2014
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01409/AM15/
RLA File :03/95/040/00701/AM15/
Lic.No/Date:0310791419 26.11.2014 Defer Date:30.12.2015 DC&PC(Chemicals).

197

Case No.:10/2/82-

ALC4/2015
Party Name:JUBILANT GENERICS LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00025/AM16/
RLA File :05/23/040/00211/AM15/
Lic.No/Date:0510392167 27.11.2014 Defer Date:30.12.2015

198

Case No.:11/2/82-

ALC4/2015
Party Name:JUBILANT GENERICS LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00026/AM16/
RLA File :05/23/040/00370/AM15/
Lic.No/Date:0510392171 27.11.2014 Defer Date:30.12.2015 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.No.35011/294/2015-PI(Norms) dated October 2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

199

Case No.:114/18/82-

ALC4/2014
Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01480/AM15/
RLA File :22/24/040/00073/AM15/
Lic.No/Date:2210015135 28.11.2014 Defer Date:30.12.2015 Decision : : Information called for from the firm is awaited. The committee accordingly deferred the case.

200

Case No.:26/18/82-

ALC4/2014
Party Name:SADHANA NITRO CHEM LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Deffered HQ File :01/82/050/01392/AM15/
RLA File :03/95/040/00714/AM15/
Lic.No/Date:0310791516 28.11.2014 Defer Date:30.12.2015 Decision : The Committee based on the written comments forwarded by the D/o C&PC, U.O.No.14010/7/2015-Ch-II dated 23.4.2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

201

Case No.:92/18/82-

ALC4/2014
Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01458/AM15/
RLA File :34/24/040/00224/AM15/
Lic.No/Date:3410040732 28.11.2014 Defer Date:30.12.2015 DC&PC(Chemicals)

202

Case No.:360/5/82-

ALC4/2015
Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00500/AM16/
RLA File :05/23/040/00386/AM15/
Lic.No/Date:0510392229 01.12.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/224/2015-PI(Norms) dated Sept. 2015 , uploaded along with these minutes or as applied by the firm whichever is less

203

Case No.:361/5/82-

ALC4/2015
Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00501/AM16/
RLA File :05/23/040/00380/AM15/
Lic.No/Date:0510392228 01.12.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/224/2015-PI(Norms) dated Sept. 2015 , uploaded along with these minutes or as applied by the firm whichever is less

204

Case No.:36/7/82-

ALC4/2015
Party Name:HEPTACHEM & PHARMA (INDIA) PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00641/AM16/
RLA File :09/24/040/00406/AM15/
Lic.No/Date:0910061331 02.12.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/463/2015-PI(Norms) dated November 2015 , uploaded along with these minutes or as applied by the firm whichever is

NC.

205

Case No.:50/5/82-

ALC4/2015
Party Name:RAJ PIONEER LABORATORIES INDIA PRIVATE LIMITED, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00190/AM16/
RLA File :56/24/040/00040/AM15/
Lic.No/Date:5610004489 03.12.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/414/2015-PI(Norms) dated Oct. 2015 , uploaded along with these minutes or as applied by the firm whichever is less

206

Case No.:87/18/82-

ALC4/2014
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01453/AM15/
RLA File :03/95/040/00755/AM15/
Lic.No/Date:0310791744 05.12.2014 Defer Date: recommendation of D/o C&PC forwarded vide U.O.No.14010/64/2013-Ch-II dated 10.03.2015 ,

207

Case No.:265/5/82-

ALC4/2015
Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00405/AM16/
RLA File :09/24/040/00479/AM15/
Lic.No/Date:0910061351 05.12.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/490/2015-PI(Norms) dated 18th November 2015 , uploaded along with 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.

208

Case No.:280/13/82-

ALC4/2014
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01283/AM15/
RLA File :09/24/040/00498/AM15/
Lic.No/Date:0910061364 09.12.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/247/2015-PI(Norms) dated Sept. 2015 , uploaded along with these minutes or as applied by the firm whichever is less

209

Case No.:82/18/82-

ALC4/2014
Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File RLA File Lic.No/Date:0510392368 Defer

:01/82/050/01448/AM15/ :05/23/040/00413/AM15/ 10.12.2014 Date:30.12.2015 Committee accordingly decided to defer the case.

210

Case No.:101/4/82-

ALC4/2015
Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00140/AM16/
RLA File :17/24/040/00144/AM15/
Lic.No/Date:1710005998 10.12.2014 Defer Date:30.12.2015 DC&PC(Chemicals)

211

Case No.:97/18/82-

ALC4/2014
Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01463/AM15/
RLA File :30/24/040/00041/AM15/
Lic.No/Date:3010103261 11.12.2014 Defer Date:30.12.2015 DC&PC(Chemicals)

212

Case No.:246/5/82-

ALC4/2015
Party Name:RAKSHIT DRUGS PVT LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00386/AM16/
RLA File :09/24/040/00426/AM15/
Lic.No/Date:0910061387 15.12.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/281/2015-PI(Norms) dated October 2015 , uploaded along with these minutes or as applied by the firm whichever is NC.

213

Case No.:119/18/82-

ALC4/2014
Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01485/AM15/
RLA File :05/24/040/00419/AM15/
Lic.No/Date:0510392414 15.12.2014 Defer Date:30.12.2015 Decision : The Committee based on the written comments forwarded by the D/o C&PC, U.O.no.14010/58/2010-Ch-II dated 17.11.2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

214

Case No.:118/18/82-

ALC4/2014
Party Name:H.J.AROCHEM PVT. LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01484/AM15/
RLA File :08/24/040/00341/AM15/
Lic.No/Date:0810134067 16.12.2014 Defer Date:30.12.2015 Committee accordingly decided to defer the case.

215 Case No.:106/18/82- Party Name:PANACEA Meet No/Date:13/82- Status:Case

ALC4/2014
BIOTEC LTD., ALC4/2015 27.11.2015 Approved HQ File :01/82/050/01472/AM15/
RLA File :05/24/040/00424/AM15/
Lic.No/Date:0510392443 16.12.2014 Defer Date:
recommendation of DBT forwarded vide O.M. No.BT/IL/05/316/2010-PID dated 29.10.2015,

216

Case No.:97/5/82-

ALC4/2015
Party Name:INDOFIL INDUSTRIES LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00237/AM16/
RLA File :03/94/040/00896/AM15/
Lic.No/Date:0310792172 19.12.2014 Defer Date: recommendation of D/o C&PC, forwarded vide U.O.No.15022/17/2012-Ch-II dated 5.10.2015 ,

217

Case No.:262/5/82-

ALC4/2015
Party Name:VARAHI PHARMA PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00402/AM16/
RLA File :09/24/040/00481/AM15/
Lic.No/Date:0910061416 22.12.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/280/2015-PI(Norms) dated October 2015, uploaded along with these minutes or as applied by the firm whichever is NC.

218

Case No.:216/5/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00356/AM16/
RLA File :09/24/040/00538/AM15/
Lic.No/Date:0910061424 22.12.2014 Defer Date: recommendation of D/o C&PC, forwarded vide U.O.no.14010/138/2011-Ch-II dated14.09.2015,

219

Case No.:108/5/82-

ALC4/2015
Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00248/AM16/
RLA File :03/94/040/00908/AM15/
Lic.No/Date:0310792384 26.12.2014 Defer Date: recommendation of D/o C&PC forwarded vide U.O.No.14010/67/2011-Ch-II dated 30.09.2015

220

Case No.:91/18/82-

ALC4/2014
Party Name:ALCHEM INTERNATIONAL LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01457/AM15/
RLA File :05/23/040/00449/AM15/
Lic.No/Date:0510392602 29.12.2014 Defer Date:30.12.2015 Committee accordingly decided to defer the case.

221

Case No.:84/18/82-

ALC4/2014
Party Name:HESTER BIOSCIENCES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01450/AM15/
RLA File :08/24/040/00362/AM15/
Lic.No/Date:0810134170 30.12.2014 Defer Date:30.12.2015 Committee accordingly decided to defer the case.

222

Case No.:222/5/82-

ALC4/2015
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00362/AM16/
RLA File :09/24/040/00553/AM15/
Lic.No/Date:0910061469 31.12.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/253/2015-PI(Norms) dated Sept. 2015, uploaded along with these minutes or as applied by the firm whichever is less

223

Case No.:3/1/82-

ALC4/2015
Party Name:JAGSONPAL PHARMACEUTICALS LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00003/AM16/
RLA File :05/23/040/00450/AM15/
Lic.No/Date:0510392649 01.01.2015 Defer Date:30.12.2015 Committee accordingly decided to defer the case.

224

Case No.:84/5/82-

ALC4/2015
Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case approved HQ File :01/82/050/00224/AM16/
RLA File :34/24/040/00259/AM15/
Lic.No/Date:3410040852 01.01.2015 Defer Date:
recommendation of D/o C&PC forwarded vide U.O.no.14010/164/2011-Ch-II dated 05.10.2015,

225

Case No.:68/5/82-

ALC4/2015
Party Name:POLYDRUG LABORATORIES PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved

HQ File :01/82/050/00208/AM16/
RLA File :03/95/040/00810/AM15/
Lic.No/Date:0310792570 02.01.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/415/2015-PI(Norms) dated Oct. 2015, uploaded along with these minutes or as applied by the firm whichever is less

226

Case No.:28/7/82-

ALC4/2015
Party Name:PARAMOUNT AROMACHEM PVT.LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00633/AM16/
RLA File :05/24/040/00428/AM15/
Lic.No/Date:0510392678 05.01.2015 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DCPC.

227

Case No.:107/5/82-

ALC4/2015
Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00247/AM16/
RLA File :03/94/040/00933/AM15/
Lic.No/Date:0310792634 07.01.2015 Defer Date: recommendation of D/o C&PC forwarded vide U.O.No.14010/67/2011-Ch-II dated 30.09.2015

228

Case No.:29/15/82-

ALC4/2014
Party Name:HONOUR LAB LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01316/AM15/
RLA File :09/24/040/00543/AM15/
Lic.No/Date:0910061501 07.01.2015 Defer Date:30.12.2015 Committee accordingly decided to defer the case.

229

Case No.:96/18/82-

ALC4/2014
Party Name:NUTRA SPECIALITIES PVT. LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01462/AM15/
RLA File :04/24/040/00248/AM15/
Lic.No/Date:0410159986 07.01.2015 Defer Date:30.12.2015 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. No.35011/268/2015-PI(Norms) dated Oct. 2015 , uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

230

Case No.:122/5/82-

ALC4/2015
Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status: Deferred HQ File :01/82/050/00262/AM16/
RLA File :03/95/040/00682/AM15/
Lic.No/Date:0310792689 08.01.2015 Defer Date: 14.01.2015 Decision : The Committee decided to defer the case for want of comments of DCPC.

231

Case No.:220/5/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00360/AM16/
RLA File :09/24/040/00560/AM15/
Lic.No/Date:0910061516 09.01.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/276/2015-PI(Norms) dated Sept. 2015 , uploaded along with these minutes or as applied by the firm whichever is less

232

Case No.:80/5/82-

ALC4/2015
Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00220/AM16/
RLA File :05/23/040/00465/AM15/
Lic.No/Date:0510392782 09.01.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/426/2015-PI(Norms) dated Oct. 2015 , uploaded along with these minutes or as applied by the firm whichever is less

233

Case No.:92/7/82-

ALC4/2015
Party Name:RIDDHI PHARMA Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00697/AM16/
RLA File :34/24/040/00266/AM15/
Lic.No/Date:3410040864 12.01.2015 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DoP.

234

Case No.:24/7/82-

ALC4/2015
Party Name:YASHASHVI RASAYAN PVT.LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00629/AM16/
RLA File :52/24/040/00056/AM15/
Lic.No/Date:5210041389 12.01.2015 Defer Date: recommendation of D/o C&PC forwarded vide U.O.No.14010/36/2010-Ch-II dated 10.11.2015 ,

235

Case No.:60/5/82-

ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00200/AM16/
RLA File :03/94/040/00963/AM15/
Lic.No/Date:0310793006 16.01.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/300/2015-PI(Norms) dated 16.11.2015 , uploaded along with these minutes or as applied by the firm whichever is less

236

Case No.:78/5/82-

ALC4/2015
Party Name:LAXMI ORGANIC INDUSTRIES LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status: Approved HQ File :01/82/050/00218/AM16/
RLA File :03/95/040/00814/AM15/
Lic.No/Date:0310793011 16.01.2015 Defer Date:15.10.2015 Decision : This case has already been approved by NC in its meeting No.10/AM16

237

Case No.:242/5/82-

ALC4/2015
Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00382/AM16/
RLA File :09/24/040/00577/AM15/
Lic.No/Date:0910061545 19.01.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No. 35011/175/2015-PI-(Norms) dated Sept. 2015, uploaded along with these minutes or as applied by the firm whichever is less

238

Case No.:249/5/82-

ALC4/2015
Party Name:PERKIN LABORATORIES Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00389/AM16/
RLA File :09/24/040/00588/AM15/
Lic.No/Date:0910061539 19.01.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No. 35011/477/2015-PI-(Norms) dated Nov. 2015, uploaded along with these minutes or as applied by the firm whichever is less

239

Case No.:110/5/82-

ALC4/2015
Party Name:UNIMAX CHEMICALS PVT LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Rejected HQ File :01/82/050/00250/AM16/
RLA File :03/95/040/00811/AM15/
Lic.No/Date:0310793038 19.01.2015 Defer Date: Decision : : In view of the facts brought to the notice by DoP, the case was rejected, copy of DoP O.M. No. 35011/315/2014-PI (norms) dated 30.09.2015 uploaded alongwith these minutes.

240

Case No.:112/5/82-

ALC4/2015
Party Name:UNIMAX CHEMICALS PVT LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status: Case Rejected HQ File :01/82/050/00252/AM16/
RLA File :03/95/040/00812/AM15/
Lic.No/Date:0310793039 19.01.2015 Defer Date: Decision : : In view of the facts brought to the notice by DoP, the case was rejected, copy of DoP O.M. No. 35011/315/2014-PI (norms) dated 30.09.2015 uploaded alongwith these minutes.

241

Case No.:132/5/82-

ALC4/2015
Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00272/AM16/
RLA File :03/94/040/00947/AM15/
Lic.No/Date:0310793170 21.01.2015 Defer Date:

recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/175(i)/2015-PI(Norms) dated Oct.2015 , uploaded along with these minutes or as applied by the firm whichever is less

242

Case No.:11/16/82-

ALC4/2014
Party Name:DR REDDYS LABORATORIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01363/AM15/
RLA File :09/24/040/00580/AM15/
Lic.No/Date:0910061549 21.01.2015 Defer Date:30.12.2015

243

Case No.:56/5/82-

ALC4/2015
Party Name:IPCA Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00196/AM16/
RLA File :03/94/040/00973/AM15/
Lic.No/Date:0310793182 21.01.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/244/2015-PI(Norms) dated Setp.2015 , uploaded along with these minutes or as applied by the firm whichever is less

244

Case No.:10/16/82-

ALC4/2014
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01362/AM15/
RLA File :09/24/040/00529/AM15/
Lic.No/Date:0910061548 21.01.2015 Defer Date:30.11.2015 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. 35011/309/2015-PI(Norms) dated Oct. 2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

245

Case No.:12/16/82-

ALC4/2014
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01364/AM15/
RLA File :09/24/040/00592/AM15/
Lic.No/Date:0910061552 21.01.2015 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DoP.

246

Case No.:165/5/82-

ALC4/2015
Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00305/AM16/
RLA File :22/24/040/00091/AM15/
Lic.No/Date:2210015173 23.01.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/407/2015-PI(Norms)

247 Case No.:77/5/82- Party Name:THINQ Meet No/Date:13/82- Status:Case

ALC4/2015
PHARMA-CRO LIMITED ALC4/2015 27.11.2015 Approved HQ File :01/82/050/00217/AM16/
RLA File :03/95/040/00857/AM15/
Lic.No/Date:0310793256 23.01.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/441/2015-PI(Norms)

248

Case No.:14/1/82-

ALC4/2015
Party Name:ANUH PHARMA LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00014/AM16/
RLA File :03/94/040/00985/AM15/
Lic.No/Date:0310793308 27.01.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/481/2015-PI(Norms) dated 24.11.2015 , uploaded along with these minutes or as applied by the firm whichever is NC.

249

Case No.:107/7/82-

ALC4/2015
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00712/AM16/
RLA File :03/94/040/00992/AM15/
Lic.No/Date:0310793305 27.01.2015 Defer Date: recommendation of D/o C&PC U.O.No.14010/47/2014-Ch-II dated 10.11.2015, uploaded along with 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.

250

Case No.:31/7/82-

ALC4/2015
Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00636/AM16/
RLA File :05/24/040/00498/AM15/
Lic.No/Date:0510392987 27.01.2015 Defer Date:30.12.2015 Decision : The Committee based on the written comments forwarded by the D/o C&PC, vide O.M. 14010/58/2010-Ch-II dated 14.08.2015 , uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

251

Case No.:32/7/82-

ALC4/2015
Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00637/AM16/
RLA File :05/24/040/00499/AM15/
Lic.No/Date:0510392988 27.01.2015 Defer Date:30.12.2015 Decision : The Committee based on the written comments forwarded by the D/o C&PC, vide O.M. 14010/58/2010-Ch-II dated 17.11.2015 , uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

252

Case No.:25/7/82-

ALC4/2015
Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File RLA File Lic.No/Date:3110065235 Defer

:01/82/050/00630/AM16/ :31/83/040/00144/AM15/ 28.01.2015 Date:30.12.2015 Decision : The Committee based on the written comments forwarded by the D/o C&PC, vide O.M. 14010/39/2011-Ch-II dated 29.09.2015 , uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

253

Case No.:230/5/82-

ALC4/2015
Party Name:R.K.INDUSTRIES, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred
HQ File :01/82/050/00370/AM16/
RLA File :08/24/040/00394/AM15/
Lic.No/Date:0810134414 28.01.2015 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DCPC.

254

Case No.:168/5/82-

ALC4/2015
Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00308/AM16/
RLA File :34/24/040/00277/AM15/
Lic.No/Date:3410040906 29.01.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/73/2015-PI(Norms) dated Sept.2015 , uploaded along with these minutes or as applied by the firm whichever is less

255

Case No.:274/5/82-

ALC4/2015
Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00414/AM16/
RLA File :03/94/040/01017/AM15/
Lic.No/Date:0310793439 30.01.2015 Defer Date: Decision : approved in meeting No.10/AM16

256

Case No.:233/5/82-

ALC4/2015
Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00373/AM16/
RLA File :05/24/040/00525/AM15/
Lic.No/Date:0510393079 04.02.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/451/2015-PI(Norms) dated Nov.2015 , uploaded along with these minutes or as applied by the firm whichever is less

257

Case No.:346/5/82-

ALC4/2015
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00486/AM16/
RLA File :03/95/040/00947/AM15/
Lic.No/Date:0310793722 09.02.2015 Defer Date: recommendation of D/o C&PC forwarded vide U.O.No.14010/95/2011-Ch-II dated 11.09.2015 ,

258

Case No.:190/5/82-

ALC4/2015
Party Name:HONOUR LAB LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00330/AM16/
RLA File :09/24/040/00629/AM15/
Lic.No/Date:0910061597 10.02.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/462/2015-PI(Norms)

259

Case No.:12/18/82-

ALC4/2014
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01378/AM15/
RLA File :09/24/040/00604/AM15/
Lic.No/Date:0910061602 10.02.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/298/2015-PI(Norms) dated 27.10.2015 , uploaded along with these minutes or as applied by the firm whichever is less

260

Case No.:286/5/82-

ALC4/2015
Party Name:GALAXY SURFACTANTS LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00426/AM16/
RLA File :03/94/040/01054/AM15/
Lic.No/Date:0310793796 11.02.2015 Defer Date: recommendation of D/o C&PC forwarded vide U.O.No.14010/148/2011-Ch-II dated 30.09.2015 ,

261

Case No.:348/5/82-

ALC4/2015
Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00488/AM16/
RLA File :03/95/040/00895/AM15/
Lic.No/Date:0310793791 11.02.2015 Defer Date: 14.01.2016

262

Case No.:91/7/82-

ALC4/2015
Party Name:SHREE GANESH REMEDIES PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00696/AM16/
RLA File :34/24/040/00295/AM15/
Lic.No/Date:3410040965 16.02.2015 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DCPC.

263 Case No.:42/5/82- Party Name:SUVEN LIFE Meet No/Date:13/82- Status:Case

ALC4/2015
SCIENCES LIMITED ALC4/2015 27.11.2015 Approved HQ File :01/82/050/00182/AM16/
RLA File :09/24/040/00633/AM15/
Lic.No/Date:0910061619 16.02.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/278/2015-PI(Norms)

264

Case No.:52/19/82-

ALC4/2014
Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01540/AM15/
RLA File :05/24/040/00273/AM15/
Lic.No/Date:0510393248 17.02.2015 Defer Date:30.12.2015 Decision : The decided to defer the case for want of comments of DCPC.

265

Case No.:38/7/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00643/AM16/
RLA File :09/24/040/00640/AM15/
Lic.No/Date:0910061628 18.02.2015 Defer Date:30.12.2015

266

Case No.:317/5/82-

ALC4/2015
Party Name:AMI LIFESCIENCES P LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00457/AM16/
RLA File :34/24/040/00305/AM15/
Lic.No/Date:3410040974 20.02.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/431/2015-PI(Norms) dated Oct. 2015 , uploaded along with these minutes or as applied by the firm whichever is less

267

Case No.:38/5/82-

ALC4/2015
Party Name:MYLAN Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00178/AM16/
RLA File :09/24/040/00591/AM15/
Lic.No/Date:0910061638 20.02.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/279/2015-PI(Norms)

268

Case No.:31/5/82-

ALC4/2015
Party Name:SRIAM LABS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00171/AM16/
RLA File :09/24/040/00630/AM15/
Lic.No/Date:0910061641 23.02.2015 Defer Date:

recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/277/2015-PI(Norms)

269

Case No.:35/7/82-

ALC4/2015
Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00640/AM16/
RLA File :08/24/040/00425/AM15/
Lic.No/Date:0810134658 24.02.2015 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DoP.

270

Case No.:1/1/82-

ALC4/2015
Party Name:PARAMOUNT AROMACHEM PVT.LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00001/AM16/
RLA File :05/24/040/00563/AM15/
Lic.No/Date:0510393385 26.02.2015 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DCPC.

271

Case No.:297/5/82-

ALC4/2015
Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00437/AM16/
RLA File :05/23/040/00510/AM15/
Lic.No/Date:0510393404 27.02.2015 Defer Date: recommendation of D/o C&PC forwarded vide U.O.No.14010/7/2011-Ch-II dated 15.09.2015 ,

272

Case No.:341/5/82-

ALC4/2015
Party Name:MANGALAM DRUGS & ORGANICS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00481/AM16/
RLA File :03/95/040/01002/AM15/
Lic.No/Date:0310794281 02.03.2015 Defer Date: 14.01.2016

273

Case No.:39/5/82-

ALC4/2015
Party Name:GRANULES INDIA LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00179/AM16/
RLA File :09/24/040/00650/AM15/
Lic.No/Date:0910061669 05.03.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/262/2015-PI(Norms)

274

Case No.:444/5/82-

ALC4/2015
Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case
HQ File :01/82/050/00584/AM16/
RLA File :03/94/040/01132/AM15/
Lic.No/Date:0310794412 09.03.2015 Defer Date:30.12.2015 Committee accordingly decided to defer the case.

275

Case No.:299/5/82-

ALC4/2015
Party Name:G.G.CHEMICALS & PHARMACEUTICALS PVT.LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00439/AM16/
RLA File :22/24/040/00106/AM15/
Lic.No/Date:2210015206 09.03.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/226/2015-PI(Norms) dated Sept.2015 , uploaded along with these minutes or as applied by the firm whichever is less

276

Case No.:423/5/82-

ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00563/AM16/
RLA File :03/94/040/01116/AM15/
Lic.No/Date:0310794418 09.03.2015 Defer Date: Decision : Approved in Meeting No.10/AM16

277

Case No.:445/5/82-

ALC4/2015
Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00585/AM16/
RLA File :03/94/040/01143/AM15/
Lic.No/Date:0310794485 10.03.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/410/2015-PI(Norms) dated Sept.2015 , uploaded along with these minutes or as applied by the firm whichever is less

278

Case No.:13/5/82-

ALC4/2015
Party Name:MYLAN Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00153/AM16/
RLA File :09/24/040/00343/AM15/
Lic.No/Date:0910061674 10.03.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/272/2015-PI(Norms)

279

Case No.:305/5/82-

ALC4/2015
Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved

HQ File :01/82/050/00445/AM16/
RLA File :05/23/040/00555/AM15/
Lic.No/Date:0510393548 12.03.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/224/2015-PI(Norms) dated Sept.2015 , uploaded along with these minutes or as applied by the firm whichever is less

280

Case No.:51/19/82-

ALC4/2014
Party Name:HONOUR LAB LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01539/AM15/
RLA File :09/24/040/00693/AM15/
Lic.No/Date:0910061695 12.03.2015 Defer Date:30.12.2015 Decision : : Requisite information has been received and send to DoP. The Committee decided to defer the case for want of comments from DoP.

281

Case No.:106/7/82-

ALC4/2015
Party Name:ALCHEMIE LABORATORIES Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00711/AM16/
RLA File :03/94/040/00812/AM15/
Lic.No/Date:0310794612 16.03.2015 Defer Date:30.12.2015

282

Case No.:421/5/82-

ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status: Approved HQ File :01/82/050/00561/AM16/
RLA File :03/94/040/01151/AM15/
Lic.No/Date:0310794615 16.03.2015 Defer Date
recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/351/2015-PI(Norms)

283

Case No.:9/5/82-

ALC4/2015
Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00149/AM16/
RLA File :09/24/040/00671/AM15/
Lic.No/Date:0910061707 16.03.2015 Defer
Decision : Approved in NC 10/AM16

284

Case No.:16/1/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01542/AM15/
RLA File :09/24/040/00703/AM15/
Lic.No/Date:0910061716 17.03.2015 Defer Date:30.12.2015 Decision : Information called for from the firm is awaited. The Committee decided to defer the case.

285 Case No.:289/5/82- ALC4/2015
Party Name:HPL ADDITIVES Meet No/Date:13/82- ALC4/2015 Status:Case Approved

LIMITED(FORMERLY KNOWN HIGH POLYMER 27.11.2015 HQ File :01/82/050/00429/AM16/
RLA File :05/23/040/00560/AM15/
Lic.No/Date:0510393593 17.03.2015 Defer Date: Decision :withdrawn: This case has already been approved in NC 10/AM16.

286

Case No.:44/5/82-

ALC4/2015
Party Name:SRIAM LABS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00184/AM16/
RLA File :09/24/040/00666/AM15/
Lic.No/Date:0910061718 17.03.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/270/2015-PI(Norms)

287

Case No.:103/7/82-

ALC4/2015
Party Name:VADIVARHE SPECIALITY CHEMICALS LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00708/AM16/
RLA File :03/95/040/01041/AM15/
Lic.No/Date:0310794641 17.03.2015 Defer Date:30.12.2015

288

Case No.:311/5/82-

ALC4/2015
Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00451/AM16/
RLA File :05/24/040/00597/AM15/
Lic.No/Date:0510393646 19.03.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/451/2015-PI(Norms)

289

Case No.:408/5/82-

ALC4/2015
Party Name:SHIRDI CHEMICALS PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00548/AM16/
RLA File :03/95/040/01059/AM15/
Lic.No/Date:0310794798 23.03.2015 Defer Date: Decision : Approved in NC 10/Am16

290

Case No.:310/5/82-

ALC4/2015
Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00450/AM16/
RLA File :05/23/040/00562/AM15/
Lic.No/Date:0510393721 24.03.2015 Defer Date: Decision : Approved in NC 10/Am16

291 Case No.:29/1/82- Party Name:HONOUR Meet No/Date:13/82- Status:Case

ALC4/2015
LAB LIMITED ALC4/2015 27.11.2015 Deferred HQ File :01/82/050/01555/AM15/
RLA File :09/24/040/00722/AM15/
Lic.No/Date:0910061789 30.03.2015 Defer Date:30.12.2015 Decision : Information called for from the firm is awaited. The Committee accordingly deferred the case.

292

Case No.:51/4/82-

ALC4/2015
Party Name:PANACEA BIOTEC LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00090/AM16/
RLA File :05/24/040/00607/AM15/
Lic.No/Date:0510393789 30.03.2015 Defer Date: recommendation of DBT forwarded vide O.M. No.BT/IL/05/316/2010-PID dated 29.10.2015,

293

Case No.:9/1/82-

ALC4/2015
Party Name:VIVIMED LABS ( ALATHUR) PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00009/AM16/
RLA File :04/24/040/00292/AM15/
Lic.No/Date:0410160364 30.03.2015 Defer Date:30.12.2015 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.35011/366/2015-PI(Noms) dated 23.11.2015 , uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

294

Case No.:104/7/82-

ALC4/2015
Party Name:ANUH PHARMA LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00709/AM16/
RLA File :03/94/040/01192/AM15/
Lic.No/Date:0310795054 31.03.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/545/2015-(Norms) dated March 2015, uploaded along with these minutes or as applied by the firm whichever is less

295

Case No.:19/5/82-

ALC4/2015
Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00159/AM16/
RLA File :08/24/040/00485/AM15/
Lic.No/Date:0810134977 31.03.2015 Defer Date: Decision :Already approved in NC 10/AM16

296

Case No.:24/5/82-

ALC4/2015
Party Name:SATYADEVA PHARMACEUTICALS /P/ LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status: Approved HQ File :01/82/050/00164/AM16/
RLA File :09/24/040/00729/AM15/
Lic.No/Date:0910061845 31.03.2015 Defer Date:
recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/409/2015-(Norms)

dated Sept. 2015, uploaded along with these minutes or as applied by the firm whichever is less

297

Case No.:40/5/82-

ALC4/2015
Party Name:VASUDHA PHARMA CHEM LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00180/AM16/
RLA File :09/24/040/00691/AM15/
Lic.No/Date:0910061852 31.03.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/255/2015-(Norms) dated Sept. 2015, uploaded along with these minutes or as applied by the firm whichever is less

298

Case No.:12/5/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00152/AM16/
RLA File :09/24/040/00627/AM15/
Lic.No/Date:0910061822 31.03.2015 Defer Date: recommendation of D/o C&PC, forwarded vide U.O.no.14010/138/2011-Ch-II dated14.09.2015,

299

Case No.:424/5/82-

ALC4/2015
Party Name:UNICHEM Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00564/AM16/
RLA File :03/95/040/01083/AM15/
Lic.No/Date:0310795220 09.04.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/336/2015-(Norms) dated 18.11. 2015, uploaded along with these minutes or as applied by the firm whichever is less

300

Case No.:97/4/82-

ALC4/2015
Party Name:ADCOCK INGRAM LTD, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00136/AM16/
RLA File :07/24/040/00484/AM15/
Lic.No/Date:0710108024 15.04.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/302/2015-(Norms) dated 27.10.2015, uploaded along with these minutes or as applied by the firm whichever is less

301

Case No.:124/8/82-

ALC4/2015
Party Name:GUJARAT ORGANICS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00920/AM16/
RLA File :03/94/040/00664/AM15/
Lic.No/Date:0310795311 15.04.2015 Defer Date: recommendation of D/o C&PC forwarded vide U.O.no.14010/11/2013-CH-II dated 30th Sept.

2015, uploaded along with 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.

302

Case No.:12/7/82-

ALC4/2015
Party Name:SHILPA MEDICARE LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00617/AM16/
RLA File :07/24/040/00002/AM16/
Lic.No/Date:0710108028 15.04.2015 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DoP

303

Case No.:144/7/82-

ALC4/2015
Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00749/AM16/
RLA File :03/94/040/01200/AM15/
Lic.No/Date:0310795391 17.04.2015 Defer Date: 30.12.2015 DC&PC(Chemicals)

304

Case No.:152/7/82-

ALC4/2015
Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00757/AM16/
RLA File :03/94/040/01210/AM15/
Lic.No/Date:0310795394 17.04.2015 Defer Date: recommendation of D/o C&PC forwarded vide U.O.No.14010/57/2012-Ch-II dated 10.11. 2015,

305

Case No.:6/5/82-

ALC4/2015
Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00146/AM16/
RLA File :08/24/040/00004/AM16/
Lic.No/Date:0810135050 17.04.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/273/2015-(Norms) dated Sept. 2015, uploaded along with these minutes or as applied by the firm whichever is less

306

Case No.:10/5/82-

ALC4/2015
Party Name:PI INDUSTRIES LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00150/AM16/
RLA File :13/24/040/00056/AM15/
Lic.No/Date:1310047840 17.04.2015 Defer Date: Decision: Already approved in NC 10/AM-16.

307

Case No.:64/8/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00860/AM16/
RLA File :09/24/040/00006/AM16/
Lic.No/Date:0910061905 21.04.2015 Defer Date:

recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/165/2015-PI(Norms) Dated Oct. 2015 , uploaded along with these minutes or as applied by the firm whichever is less

308

Case No.:147/7/82-

ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00752/AM16/
RLA File :03/94/040/00036/AM16/
Lic.No/Date:0310795446 21.04.2015 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DoP

309

Case No.:164/13/82-

ALC4/2015
Party Name:NUTRA SPECIALITIES PVT. LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01127/AM16/
RLA File :04/24/040/00004/AM16/
Lic.No/Date:0410160435 23.04.2015 Defer Date:30.12.2015

310

Case No.:29/7/82-

ALC4/2015
Party Name:NUTRA SPECIALITIES PVT. LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00634/AM16/
RLA File :04/24/040/00003/AM16/
Lic.No/Date:0410160438 24.04.2015 Defer Date:30.11.2015

311

Case No.:173/7/82-

ALC4/2015
Party Name:UNIMAX LABORATORIES PVT.LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00778/AM16/
RLA File :03/95/040/00031/AM16/
Lic.No/Date:0310795525 24.04.2015 Defer Date:30.12.2015

312

Case No.:155/7/82-

ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00760/AM16/
RLA File :03/94/040/00035/AM16/
Lic.No/Date:0310795581 28.04.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/290/2015-PI(Norms) dated November 2015 , uploaded along with these minutes or as applied by the firm whichever is NC.

313

Case No.:174/7/82-

ALC4/2015
Party Name:S M B CORPORATION OF INDIA Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00779/AM16/
RLA File :03/95/040/00039/AM16/
Lic.No/Date:0310795601 28.04.2015 Defer Date:30.12.2015

Committee accordingly decided await the reply and deferred the case.

314

Case No.:34/8/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00830/AM16/
RLA File :09/24/040/00014/AM16/
Lic.No/Date:0910061946 29.04.2015 Defer Date: recommendation of D/o C&PC, forwarded vide U.O.no.14010/138/2011-Ch-II dated14.09.2015,

315

Case No.:151/7/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00756/AM16/
RLA File :03/94/040/01216/AM15/
Lic.No/Date:0310795663 30.04.2015 Defer Date:30.12.2015 Committee accordingly decided await the reply and deferred the case.

316

Case No.:21/5/82-

ALC4/2015
Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00161/AM16/
RLA File :05/23/040/00003/AM16/
Lic.No/Date:0510394100 05.05.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/403/2015-PI(Norms) dated Sept.2015 , uploaded along with these minutes or as applied by the firm whichever is less

317

Case No.:8/13/82-

ALC4/2015
Party Name:DORF- KETAL CHEMICALS INDIA PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00971/AM16/
RLA File :03/94/040/00044/AM16/
Lic.No/Date:0310795702 05.05.2015 Defer Date:30.12.2015 DC&PC(Chemicals)

318

Case No.:47/13/82-

ALC4/2015
Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01010/AM16/
RLA File :03/94/040/00016/AM16/
Lic.No/Date:0310795703 05.05.2015 Defer Date:30.12.2015 DC&PC(Chemicals)

319 Case No.:50/7/82- ALC4/2015
Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:13/82- ALC4/2015 Status:Case Deferred

27.11.2015 HQ File :01/82/050/00655/AM16/
RLA File :09/24/040/00041/AM16/
Lic.No/Date:0910061976 06.05.2015 Defer Date:30.12.2015

320

Case No.:4/7/82-

ALC4/2015
Party Name:POSY PHARMACHEM PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00609/AM16/
RLA File :08/24/040/00006/AM16/
Lic.No/Date:0810135194 06.05.2015 Defer Date:30.12.2015

321

Case No.:11/7/82-

ALC4/2015
Party Name:CADILA HEALTHCARE LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00616/AM16/
RLA File :08/24/040/00016/AM16/
Lic.No/Date:0810135204 07.05.2015 Defer Date:30.12.2015

322

Case No.:23/7/82-

ALC4/2015
Party Name:CADILA HEALTHCARE LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00628/AM16/
RLA File :08/24/040/00028/AM16/
Lic.No/Date:0810135220 07.05.2015 Defer Date:30.12.2015

323

Case No.:3/3/82-

ALC4/2015
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00033/AM16/
RLA File :09/24/040/00077/AM16/
Lic.No/Date:0910061994 07.05.2015 Defer Date:30.12.2015

324

Case No.:108/7/82-

ALC4/2015
Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00713/AM16/
RLA File :03/95/040/00003/AM16/
Lic.No/Date:0310795745 07.05.2015 Defer Date:30.12.2015 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. No.35011/337/2015-PI(Norms) dated Nov. 2015 , uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

325

Case No.:191/7/82-

ALC4/2015
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00796/AM16/
RLA File :03/95/040/00065/AM16/
Lic.No/Date:0310795759 07.05.2015 Defer Date: recommendation of D/o C&PC, forwarded vide U.O.no.14010/62/2010-Ch-II dated 02.12.2015 ,

326

Case No.:7/7/82-

ALC4/2015
Party Name:SWISS PARENTERALS PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00612/AM16/
RLA File :08/24/040/00017/AM16/
Lic.No/Date:0810135225 08.05.2015 Defer Date:30.12.2015

327

Case No.:8/7/82-

ALC4/2015
Party Name:SWISS PARENTERALS PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00613/AM16/
RLA File :08/24/040/00018/AM16/
Lic.No/Date:0810135226 08.05.2015 Defer Date:30.12.2015

328

Case No.:117/7/82-

ALC4/2015
Party Name:ZIM LABORATORIES LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00722/AM16/
RLA File :03/95/040/00079/AM16/
Lic.No/Date:0310795788 08.05.2015 Defer Date:30.12.2015

329

Case No.:30/7/82-

ALC4/2015
Party Name:KLJ PLASTICIZERS LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00635/AM16/
RLA File :05/23/040/00033/AM16/
Lic.No/Date:0510394185 11.05.2015 Defer Date: recommendation of D/o C&PC, forwarded vide U.O.No.14010/36/2011-CH-II dated 19.10.2015 ,

330

Case No.:15/7/82-

ALC4/2015
Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00620/AM16/
RLA File :52/24/040/00007/AM16/
Lic.No/Date:5210041517 11.05.2015 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of DCPC

331

Case No.:139/7/82-

ALC4/2015
Party Name:LUPIN LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00744/AM16/
RLA File :03/95/040/00068/AM16/
Lic.No/Date:0310795837 12.05.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/589/2015-PI(Norms) dated 17.11.2015 , uploaded along with these minutes or as applied by the firm whichever is less

332

Case No.:140/7/82-

ALC4/2015
Party Name:LUPIN LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Approved HQ File :01/82/050/00745/AM16/
RLA File :03/95/040/00067/AM16/
Lic.No/Date:0310795839 12.05.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/589/2015-PI(Norms) dated 17.11.2015 , uploaded along with these minutes or as applied by the firm whichever is less

333

Case No.:49/7/82-

ALC4/2015
Party Name:BRUNDAVAN LABORATORIES PRIVATE LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00654/AM16/
RLA File :09/24/040/00059/AM16/
Lic.No/Date:0910062011 13.05.2015 Defer Date:30.12.2015

334

Case No.:31/8/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00827/AM16/
RLA File :09/24/040/00083/AM16/
Lic.No/Date:0910062012 13.05.2015 Defer Date: recommendation of D/o C&PC, forwarded vide U.O.No.14010/138/2011-Ch-II dated 14.09.2015,

335

Case No.:7/13/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00970/AM16/
RLA File :09/24/040/00046/AM16/
Lic.No/Date:0910062017 14.05.2015 Defer Date:30.12.2015

336

Case No.:5/3/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00035/AM16/
RLA File :09/24/040/00081/AM16/
Lic.No/Date:0910062019 14.05.2015 Defer Date:30.12.2015

337

Case No.:129/7/82-

ALC4/2015
Party Name:NATIONAL TUBE INDUSTRIES, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00734/AM16/
RLA File :03/95/040/00073/AM16/
Lic.No/Date:0310795930 14.05.2015 Defer Date:30.12.2015

338

Case No.:6/7/82-

ALC4/2015
Party Name:SIMPEX PHARMA PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00611/AM16/
RLA File :05/24/040/00564/AM15/
Lic.No/Date:0510394266 15.05.2015 Defer Date:30.12.2015

339

Case No.:164/7/82-

ALC4/2015
Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00769/AM16/
RLA File :03/94/040/00026/AM16/
Lic.No/Date:0310795971 18.05.2015 Defer Date:27.11.2015 Decision : Information called for from the firm is awaited. The case was deferred.

340

Case No.:126/7/82-

ALC4/2015
Party Name:SANDOZ PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00731/AM16/
RLA File :03/95/040/00071/AM16/
Lic.No/Date:0310795986 18.05.2015 Defer Date:30.12.2015

341

Case No.:109/7/82-

ALC4/2015
Party Name:ZIM LABORATORIES LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00714/AM16/
RLA File :03/95/040/00103/AM16/
Lic.No/Date:0310795994 18.05.2015 Defer Date:30.12.2015

34 2

Case No.:46/8/82-

ALC4/2015
Party Name:SMILAX LABORATORIES LIMI TED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status: Case Approve d HQ File :01/82/050/00842/AM 16/
RLA File :09/24/040/00027/AM16/
Lic.No/Date:09100620 40 19.05.2015 Defer Date: Decision :Already approved in NC meeting No.10/AM16

343

Case No.:133/7/82-

ALC4/2015
Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00738/AM16/
RLA File :03/94/040/00085/AM16/
Lic.No/Date:0310796048 20.05.2015 Defer Date:30.12.2015

344

Case No.:41/7/82-

ALC4/2015
Party Name:KORES (INDIA) LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00646/AM16/
RLA File :31/83/040/00196/AM15/
Lic.No/Date:3110065441 20.05.2015 Defer Date:30.12.2015

345

Case No.:102/7/82-

ALC4/2015
Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00707/AM16/
RLA File :30/24/040/00006/AM16/
Lic.No/Date:3010103498 21.05.2015 Defer Date:30.12.2015

346

Case No.:66/8/82-

ALC4/2015
Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00862/AM16/
RLA File :09/24/040/00084/AM16/
Lic.No/Date:0910062054 21.05.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/490/2015-PI(Norms) dated Nov.2015, uploaded along with these minutes or as applied by the firm whichever is less

347

Case No.:51/7/82-

ALC4/2015
Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00656/AM16/
RLA File :09/24/040/00096/AM16/
Lic.No/Date:0910062060 22.05.2015 Defer Date:30.12.2015 Committee accordingly decided await the reply and deferred the case.

348

Case No.:55/13/82-

ALC4/2015
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01018/AM16/
RLA File :07/24/040/00036/AM16/
Lic.No/Date:0710108251 22.05.2015 Defer Date:30.12.2015

349

Case No.:167/7/82-

ALC4/2015
Party Name:IPCA LABORATORIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00772/AM16/
RLA File :03/94/040/00041/AM16/
Lic.No/Date:0310796129 22.05.2015 Defer Date:30.12.2015

350

Case No.:3/4/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00042/AM16/
RLA File :09/24/040/00104/AM16/
Lic.No/Date:0910062064 25.05.2015 Defer Date:30.12.2015 Committee accordingly decided await the reply and deferred the case.

351 Case No.:13/7/82- Party Name:MOREPEN Meet No/Date:13/82- Status:Case

ALC4/2015
LABORATORIES LTD., ALC4/2015 27.11.2015 Deferred HQ File :01/82/050/00618/AM16/
RLA File :05/24/040/00074/AM16/
Lic.No/Date:0510394343 25.05.2015 Defer Date:30.12.2015

352

Case No.:170/7/82-

ALC4/2015
Party Name:FERMENTA BIOTECH LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00775/AM16/
RLA File :03/94/040/00009/AM16/
Lic.No/Date:0310796191 26.05.2015 Defer Date:30.12.2015 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.No.35011/478/2015-PI(Norms) dated Nov. 2015. , uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

353

Case No.:176/7/82-

ALC4/2015
Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00781/AM16/
RLA File :03/94/040/00124/AM16/
Lic.No/Date:0310796194 26.05.2015 Defer Date:30.12.2015

354

Case No.:166/7/82-

ALC4/2015
Party Name:IPCA LABORATORIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00771/AM16/
RLA File :03/94/040/00063/AM16/
Lic.No/Date:0310796196 26.05.2015 Defer Date:30.12.2015

355

Case No.:162/7/82-

ALC4/2015
Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00767/AM16/
RLA File :03/94/040/00107/AM16/
Lic.No/Date:0310796189 26.05.2015 Defer Date: recommendation of D/o C&PC, forwarded vide U.O.no.14010/100/2012-CH-II dated 10.11.2015 ,

356

Case No.:124/7/82-

ALC4/2015
Party Name:PRIVI ORGANICS LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00729/AM16/
RLA File :03/95/040/00114/AM16/
Lic.No/Date:0310796233 27.05.2015 Defer Date:30.12.2015

357 Case No.:100/7/82- ALC4/2015
Party Name:SHREE GANESH REMEDIES Meet No/Date:13/82- ALC4/2015 Status:Case Deferred

PVT.LTD. 27.11.2015 HQ File :01/82/050/00705/AM16/
RLA File :34/24/040/00024/AM16/
Lic.No/Date:3410041261 28.05.2015 Defer Date:30.12.2015

358

Case No.:184/7/82-

ALC4/2015
Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00789/AM16/
RLA File :22/24/040/00009/AM16/
Lic.No/Date:2210015246 28.05.2015 Defer Date:30.12.2015

359

Case No.:188/7/82-

ALC4/2015
Party Name:ATUL LIMITED, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00793/AM16/
RLA File :08/24/040/00034/AM16/
Lic.No/Date:0810135421 02.06.2015 Defer Date:30.12.2015

360

Case No.:14/7/82-

ALC4/2015
Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00619/AM16/
RLA File :05/23/040/00075/AM16/
Lic.No/Date:0510394413 02.06.2015 Defer Date:30.12.2015

361

Case No.:5/7/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00610/AM16/
RLA File :05/24/040/00090/AM16/
Lic.No/Date:0510394416 02.06.2015 Defer Date:30.12.2015

362

Case No.:142/7/82-

ALC4/2015
Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00747/AM16/
RLA File :03/94/040/00159/AM16/
Lic.No/Date:0310796401 03.06.2015 Defer Date:30.12.2015

363

Case No.:134/7/82-

ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00739/AM16/
RLA File :03/94/040/00154/AM16/
Lic.No/Date:0310796399 03.06.2015 Defer Date:30.12.2015

364

Case No.:110/7/82-

ALC4/2015
Party Name:RISHABH METALS & CHEMICALS PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred

HQ File :01/82/050/00715/AM16/
RLA File :03/95/040/00051/AM16/
Lic.No/Date:0310796383 03.06.2015 Defer Date:30.12.2015 Decision : The Committee decided to defer the case for want of comments of cpc (Petrochemicals).

365

Case No.:16/7/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00621/AM16/
RLA File :05/24/040/00084/AM16/
Lic.No/Date:0510394419 03.06.2015 Defer Date:30.12.2015

366

Case No.:17/7/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00622/AM16/
RLA File :05/24/040/00078/AM16/
Lic.No/Date:0510394418 03.06.2015 Defer Date:30.12.2015

367

Case No.:105/7/82-

ALC4/2015
Party Name:SAVLA CHEMICALS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00710/AM16/
RLA File :03/95/040/00159/AM16/
Lic.No/Date:0310796432 04.06.2015 Defer Date: recommendation of D/o C&PC, forwarded vide U.O.No.14010/71/2014-Ch-II dated 10.11.2015 ,

368

Case No.:187/7/82-

ALC4/2015
Party Name:ATUL LIMITED, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00792/AM16/
RLA File :08/24/040/00057/AM16/
Lic.No/Date:0810135435 05.06.2015 Defer Date:30.12.2015

369

Case No.:62/7/82-

ALC4/2015
Party Name:EYTAN LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00667/AM16/
RLA File :09/24/040/00598/AM15/
Lic.No/Date:0910062137 05.06.2015 Defer Date:30.12.2015

370

Case No.:135/7/82-

ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00740/AM16/
RLA File :03/94/040/00153/AM16/
Lic.No/Date:0310796471 05.06.2015 Defer Date:

recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/555/2014-PI(Norms) dated 26.2.2015 uploaded along with these minutes or as applied by the firm whichever is less

371

Case No.:67/7/82-

ALC4/2015
Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00672/AM16/
RLA File :09/24/040/00105/AM16/
Lic.No/Date:0910062138 05.06.2015 Defer Date:30.12.2015

372

Case No.:13/9/82-

ALC4/2015
Party Name:SHILPA MEDICARE LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00949/AM16/
RLA File :07/24/040/00081/AM16/
Lic.No/Date:0710108327 05.06.2015 Defer Date:30.12.2015

373

Case No.:121/7/82-

ALC4/2015
Party Name:UNIMARK REMEDIES LIMITED., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00726/AM16/
RLA File :03/95/040/00715/AM15/
Lic.No/Date:0310796458 05.06.2015 Defer Date:30.12.2015

374

Case No.:123/7/82-

ALC4/2015
Party Name:UNIMARK REMEDIES LIMITED., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00728/AM16/
RLA File :03/95/040/00582/AM15/
Lic.No/Date:0310796457 05.06.2015 Defer Date:30.12.2015

375

Case No.:97/7/82-

ALC4/2015
Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00702/AM16/
RLA File :34/24/040/00062/AM16/
Lic.No/Date:3410041281 09.06.2015 Defer Date:30.12.2015

376

Case No.:136/7/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00741/AM16/
RLA File :03/94/040/00032/AM16/
Lic.No/Date:0310796511 09.06.2015 Defer Date:30.12.2015 Decision: Information called for from the firm is awaited. The Committee decided to await the

377 Case No.:85/7/82- Party Name:SHREEGEN Meet No/Date:13/82- Status:Case

ALC4/2015
PHARMA LTD ALC4/2015 27.11.2015 Deferred HQ File :01/82/050/00690/AM16/
RLA File :09/24/040/00130/AM16/
Lic.No/Date:0910062145 09.06.2015 Defer Date:30.12.2015

378

Case No.:60/7/82-

ALC4/2015
Party Name:GRANULES INDIA LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00665/AM16/
RLA File :09/24/040/00126/AM16/
Lic.No/Date:0910062150 10.06.2015 Defer Date:30.12.2015

379

Case No.:61/7/82-

ALC4/2015
Party Name:GRANULES INDIA LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00666/AM16/
RLA File :09/24/040/00141/AM16/
Lic.No/Date:0910062149 10.06.2015 Defer Date:30.12.2015

380

Case No.:137/7/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00742/AM16/
RLA File :03/94/040/00074/AM16/
Lic.No/Date:0310796546 10.06.2015 Defer Date:30.12.2015 Decision : Information called for from the firm is awaited. The Committee decided to await the

381

Case No.:18/13/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00981/AM16/
RLA File :03/94/040/00084/AM16/
Lic.No/Date:0310796548 10.06.2015 Defer Date:30.12.2015 Decision : Information called for from the firm is awaited. The Committee decided to await the

382

Case No.:21/13/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00984/AM16/
RLA File :03/94/040/00078/AM16/
Lic.No/Date:0310796547 10.06.2015 Defer Date:30.12.2015 Decision : Information called for from the firm is awaited. The Committee decided to await the

383

Case No.:182/7/82-

ALC4/2015
Party Name:SAURAV CHEMICALS LTD, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File RLA File Lic.No/Date:2210015251 Defer Date:

:01/82/050/00787/AM16/
:22/24/040/00006/AM16/
10.06.2015 Decision : In the light of earlier decision taken by NC in its meeting No.2/82 dated 29.04. 2015, and in consultation with technical authority present in meeting, decided to revise norms under

para 4.7 of HBP as per details given below or as applied by firm whichever is lower:-

Export product Export Qty. Sl.No. Import items Qty. allowed
LEVOFLOXACIN HEMIHYDRATE 1kg. 1. LEVOFLOXACIN Q ACID

0.8571 kg/kg

RA concerned may take further necessary action as per above decision of Norms committee.

384

Case No.:14/9/82-

ALC4/2015
Party Name:SHILPA MEDICARE LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00950/AM16/
RLA File :07/24/040/00078/AM16/
Lic.No/Date:0710108349 10.06.2015 Defer Date:30.12.2015

385

Case No.:65/7/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00670/AM16/
RLA File :09/24/040/00164/AM16/
Lic.No/Date:0910062163 10.06.2015 Defer Date:30.12.2015 Decision : Committee noted that information called for from the firm is awaited. Accordingly, the Committee decided to await the reply and deferred the case.

386

Case No.:66/7/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00671/AM16/
RLA File :09/24/040/00162/AM16/
Lic.No/Date:0910062162 10.06.2015 Defer Date:30.12.2015

387

Case No.:19/13/82-

ALC4/2015
Party Name:AMRUTA INDUSTRIES Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00982/AM16/
RLA File :03/94/040/00156/AM16/
Lic.No/Date:0310796569 11.06.2015 Defer Date:30.12.2015

388

Case No.:20/13/82-

ALC4/2015
Party Name:JAYANT AGRO ORGANICS LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00983/AM16/
RLA File :03/94/040/00169/AM16/
Lic.No/Date:0310796563 11.06.2015 Defer Date:30.12.2015

389 Case No.:159/7/82- Party Name:VIJAY Meet No/Date:13/82- Status:Case

ALC4/2015
PERFUMES PVT.LTD. ALC4/2015 27.11.2015 Deferred HQ File :01/82/050/00764/AM16/
RLA File :03/95/040/00985/AM15/
Lic.No/Date:0310796576 11.06.2015 Defer Date:30.12.2015

390

Case No.:87/7/82-

ALC4/2015
Party Name:VISION DRUGS PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00692/AM16/
RLA File :09/24/040/00102/AM16/
Lic.No/Date:0910062168 11.06.2015 Defer Date:30.12.2015 Decision : The Committee based on the written comments forwarded by the D/o C&PC, D/o Pharmaceuticals vide O.M. No.35011/487/2015-PI(Norms) dated Nov.2015 , uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

391

Case No.:42/13/82-

ALC4/2015
Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01005/AM16/
RLA File :03/94/040/00177/AM16/
Lic.No/Date:0310796604 15.06.2015 Defer Date:30.12.2015 Decision : The Committee decided sent the copy of application to DOP.

392

Case No.:160/13/82-

ALC4/2015
Party Name:ENALTEC LABS PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01123/AM16/
RLA File :03/94/040/00200/AM16/
Lic.No/Date:0310796630 15.06.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/227/2015-PI(Norms) dated Sept. 2015 , uploaded along with these minutes or as applied by the firm whichever is less

393

Case No.:171/7/82-

ALC4/2015
Party Name:MAKSON INDUSTRIES PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00776/AM16/
RLA File :03/95/040/01080/AM15/
Lic.No/Date:0310796624 15.06.2015 Defer Date: recommendation of D/o C&PC, forwarded vide O.M. No.23(2)/2014-Chem.304 (MSME) dated 5.11.2015 , uploaded along with 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.

394

Case No.:172/7/82-

ALC4/2015
Party Name:MAKSON INDUSTRIES PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00777/AM16/
RLA File :03/95/040/01079/AM15/
Lic.No/Date:0310796623 15.06.2015 Defer Date:

recommendation of D/o C&PC, forwarded vide O.M. No.23(2)/2014-Chem.304 (MSME) dated 5.11.2015 , uploaded along with 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.

395

Case No.:84/13/82-

ALC4/2015
Party Name:TIDE INDUSTRIES Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01047/AM16/
RLA File :34/24/040/00066/AM16/
Lic.No/Date:3410041297 15.06.2015 Defer Date:30.12.2015

396

Case No.:41/13/82-

ALC4/2015
Party Name:DANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01004/AM16/
RLA File :03/94/040/00111/AM16/
Lic.No/Date:0310796667 16.06.2015 Defer Date:30.12.2015

397

Case No.:185/5/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00325/AM16/
RLA File :09/24/040/00161/AM16/
Lic.No/Date:0910062185 16.06.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. 35011/534/2015-PI(Norms) dated 24.11.2015 , uploaded along with 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.

398

Case No.:54/7/82-

ALC4/2015
Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00659/AM16/
RLA File :05/23/040/00065/AM16/
Lic.No/Date:0510394575 16.06.2015 Defer Date: recommendation of D/o C&PC, forwarded vide U.O.No.14010/7/2011-Ch-II dated 29.5.2015, HBP Vol.1. RA concerned may take necessary action as per decision of NC

399

Case No.:55/7/82-

ALC4/2015
Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00660/AM16/
RLA File :05/23/040/00030/AM16/
Lic.No/Date:0510394579 16.06.2015 Defer Date: recommendation of D/o C&PC, forwarded vide U.O.No.14010/7/2011-Ch-II dated 17.11.2015,

HBP Vol.1. RA concerned may take necessary action as per decision of NC

400

Case No.:186/5/82-

ALC4/2015
Party Name:DR REDDYS Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00326/AM16/
RLA File :09/24/040/00150/AM16/
Lic.No/Date:0910062206 17.06.2015 Defer Date: Decision :Already approved in NCM 12/AM16

401

Case No.:52/7/82-

ALC4/2015
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00657/AM16/
RLA File :05/23/040/00107/AM16/
Lic.No/Date:0510394590 17.06.2015 Defer Date:30.12.2015

402

Case No.:86/7/82-

ALC4/2015
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00691/AM16/
RLA File :09/24/040/00160/AM16/
Lic.No/Date:0910062204 17.06.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/329/2015-PI(Norms) dated Nov. 2015, uploaded along with 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

403

Case No.:190/7/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00795/AM16/
RLA File :05/24/040/00105/AM16/
Lic.No/Date:0510394617 17.06.2015 Defer Date:30.12.2015

404

Case No.:37/13/82-

ALC4/2015
Party Name:ATLAS FINE CHEMICALS PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01000/AM16/
RLA File :03/94/040/00148/AM16/
Lic.No/Date:0310796714 18.06.2015 Defer Date:30.12.2015

405

Case No.:43/13/82-

ALC4/2015
Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01006/AM16/
RLA File :03/94/040/00178/AM16/
Lic.No/Date:0310796712 18.06.2015 Defer Date:30.12.2015

406

Case No.:454/5/82-

ALC4/2015
Party Name:CADILA HEALTHCARE LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00594/AM16/
RLA File :08/24/040/00081/AM16/
Lic.No/Date:0810135519 22.06.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/358/2014-PI (Norms) dated January 2015, uploaded along with these minutes or as applied by the firm whichever is NC.

407

Case No.:455/5/82-

ALC4/2015
Party Name:CADILA HEALTHCARE LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00595/AM16/
RLA File :08/24/040/00082/AM16/
Lic.No/Date:0810135520 22.06.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/570/2013-PI (Norms) dated 24.12.2013, uploaded along with these minutes or as applied by the firm whichever is less

408

Case No.:15/9/82-

ALC4/2015
Party Name:KDAC CHEM PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00951/AM16/
RLA File :34/24/040/00069/AM16/
Lic.No/Date:3410041310 22.06.2015 Defer Date:30.12.2015 DC&PC(Chemicals)

409

Case No.:183/7/82-

ALC4/2015
Party Name:SAURAV CHEMICALS LTD, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00788/AM16/
RLA File :22/24/040/00010/AM16/
Lic.No/Date:2210015259 22.06.2015 Defer Date:30.12.2015

410

Case No.:2/6/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case
deferred HQ File :01/82/050/00598/AM16/
RLA File :09/24/040/00165/AM16/
Lic.No/Date:0910062242 23.06.2015 Defer Date30.12.2015:

411

Case No.:25/13/82-

ALC4/2015
Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00988/AM16/
RLA File :03/94/040/00196/AM16/
Lic.No/Date:0310796758 23.06.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/500/2014-PI(Norms)

dated March 2015 , uploaded along with these minutes or as applied by the firm whichever is NC.

412

Case No.:26/13/82-

ALC4/2015
Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00989/AM16/
RLA File :03/94/040/00164/AM16/
Lic.No/Date:0310796757 23.06.2015 Defer Date:30.12.2015

413

Case No.:27/13/82-

ALC4/2015
Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00990/AM16/
RLA File :03/94/040/00197/AM16/
Lic.No/Date:0310796759 23.06.2015 Defer Date:30.12.2015

414

Case No.:28/13/82-

ALC4/2015
Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00991/AM16/
RLA File :03/94/040/00162/AM16/
Lic.No/Date:0310796761 23.06.2015 Defer Date:30.12.2015

415

Case No.:29/13/82-

ALC4/2015
Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00992/AM16/
RLA File :03/94/040/00161/AM16/
Lic.No/Date:0310796756 23.06.2015 Defer Date:30.12.2015

416

Case No.:30/13/82-

ALC4/2015
Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00993/AM16/
RLA File :03/94/040/00128/AM16/
Lic.No/Date:0310796760 23.06.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/500/2014-PI(Norms) dated March 2015 , uploaded along with these minutes or as applied by the firm whichever is NC.

417

Case No.:31/13/82-

ALC4/2015
Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00994/AM16/
RLA File :03/94/040/00198/AM16/
Lic.No/Date:0310796762 23.06.2015 Defer Date:30.12.2015

418

Case No.:83/13/82-

ALC4/2015
Party Name:RIDDHI PHARMA Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01046/AM16/
RLA File :34/24/040/00087/AM16/
Lic.No/Date:3410041313 23.06.2015 Defer Date:30.12.2015

419

Case No.:15/13/82-

ALC4/2015
Party Name:ALIVIRA ANIMAL HEALTH LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00978/AM16/
RLA File :03/94/040/00219/AM16/
Lic.No/Date:0310796797 24.06.2015 Defer Date:30.12.2015

420

Case No.:45/7/82-

ALC4/2015
Party Name:EYTAN LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00650/AM16/
RLA File :09/24/040/00135/AM16/
Lic.No/Date:0910062250 24.06.2015 Defer Date:30.12.2015

421

Case No.:16/13/82-

ALC4/2015
Party Name:IPCA LABORATORIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00979/AM16/
RLA File :03/94/040/00224/AM16/
Lic.No/Date:0310796798 24.06.2015 Defer Date:30.12.2015

422

Case No.:100/8/82-

ALC4/2015
Party Name:REANNON PHARMACEUTICALS Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00896/AM16/
RLA File :03/95/040/00134/AM16/
Lic.No/Date:0310796838 24.06.2015 Defer Date: Decision : approved in NC M 10/AM16

423

Case No.:64/7/82-

ALC4/2015
Party Name:TRIMAX BIO SCIENCES PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00669/AM16/
RLA File :09/24/040/00133/AM16/
Lic.No/Date:0910062246 24.06.2015 Defer Date:30.12.2015

424

Case No.:48/7/82-

ALC4/2015
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00653/AM16/
RLA File :09/24/040/00118/AM16/
Lic.No/Date:0910062253 25.06.2015 Defer Date:30.12.2015

425 Case No.:27/7/82- Party Name:PANACEA Meet No/Date:13/82- Status:Case

ALC4/2015
BIOTEC LTD., ALC4/2015 27.11.2015 Approved HQ File :01/82/050/00632/AM16/
RLA File :05/24/040/00146/AM16/
Lic.No/Date:0510394710 25.06.2015 Defer Date: recommendation of DBT forwarded vide O.M. No.BT/IL/05/316/2010-PID dated 29.10.2015,

426

Case No.:72/7/82-

ALC4/2015
Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00677/AM16/
RLA File :05/24/040/00104/AM16/
Lic.No/Date:0510394704 25.06.2015 Defer Date:30.12.2015

427

Case No.:76/7/82-

ALC4/2015
Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00681/AM16/
RLA File :05/24/040/00103/AM16/
Lic.No/Date:0510394703 25.06.2015 Defer Date:30.12.2015

428

Case No.:75/7/82-

ALC4/2015
Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00680/AM16/
RLA File :05/24/040/00122/AM16/
Lic.No/Date:0510394696 25.06.2015 Defer Date:30.12.2015

429

Case No.:78/7/82-

ALC4/2015
Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00683/AM16/
RLA File :02/24/040/00028/AM16/
Lic.No/Date:0210205920 25.06.2015 Defer Date:30.12.2015

430

Case No.:89/7/82-

ALC4/2015
Party Name:HALDIA PETROCHEMICALS LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00694/AM16/
RLA File :02/24/040/00045/AM16/
Lic.No/Date:0210205925 26.06.2015 Defer Date:30.12.2015 Decision : Information called for from the firm is awaited. The Committee decided to await the

431

Case No.:77/7/82-

ALC4/2015
Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00682/AM16/
RLA File :05/24/040/00130/AM16/
Lic.No/Date:0510394732 26.06.2015 Defer Date:30.12.2015

432

Case No.:26/7/82-

ALC4/2015
Party Name:SOFTGEL HEALTH CARE PVT. LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00631/AM16/
RLA File :04/24/040/00072/AM16/
Lic.No/Date:0410160709 26.06.2015 Defer Date:30.12.2015

433

Case No.:181/7/82-

ALC4/2015
Party Name:CLARION DRUGS LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00786/AM16/
RLA File :50/24/040/00002/AM16/
Lic.No/Date:5010002211 29.06.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/463/2015-PI(Norms)

434

Case No.:38/13/82-

ALC4/2015
Party Name:FDC LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01001/AM16/
RLA File :03/94/040/00103/AM16/
Lic.No/Date:0310796936 29.06.2015 Defer Date:
recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/149/2015-PI(Norms) dated Sept.2015 , uploaded along with these minutes or as applied by the firm whichever is less

435

Case No.:57/7/82-

ALC4/2015
Party Name:KLJ PLASTICIZERS LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00662/AM16/
RLA File :05/23/040/00112/AM16/
Lic.No/Date:0510394740 29.06.2015 Defer Date: recommendation of D/o C&PC, forwarded vide U.O.No.14010/36/2011-Ch-II dated 19.10.2015 ,

436

Case No.:58/7/82-

ALC4/2015
Party Name:KLJ PLASTICIZERS LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00663/AM16/
RLA File :05/23/040/00111/AM16/
Lic.No/Date:0510394739 29.06.2015 Defer Date: recommendation of D/o C&PC, forwarded vide U.O.No.14010/36/2011-Ch-II dated 19.10.2015 ,

437

Case No.:3/6/82-ALC4/2015 Party Name:AUROBINDO

PHARMA LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00599/AM16/
RLA File :09/24/040/00179/AM16/
Lic.No/Date:0910062259 30.06.2015 Defer Date: 14.01.2016

438

Case No.:17/13/82-

ALC4/2015
Party Name:FDC LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00980/AM16/
RLA File :03/94/040/00220/AM16/
Lic.No/Date:0310796950 30.06.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/238/2013-PI(Norms) dated 24.6.2013 , uploaded along with these minutes or as applied by the firm whichever is less

439

Case No.:33/13/82-

ALC4/2015
Party Name:FDC LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00996/AM16/
RLA File :03/94/040/00222/AM16/
Lic.No/Date:0310796951 30.06.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/352/2015-PI(Norms)

440

Case No.:34/13/82-

ALC4/2015
Party Name:FDC LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00997/AM16/
RLA File :03/94/040/00002/AM16/
Lic.No/Date:0310796945 30.06.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/352/2015-PI(Norms)

441

Case No.:35/13/82-

ALC4/2015
Party Name:FDC LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00998/AM16/
RLA File :03/94/040/00001/AM16/
Lic.No/Date:0310796946 30.06.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/149/2015-PI(Norms) dated 11.09.2015 , uploaded along with these minutes or as applied by the firm whichever is less

442

Case No.:36/13/82-

ALC4/2015
Party Name:FDC LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File RLA File Lic.No/Date:0310796944 Defer Date:

:01/82/050/00999/AM16/
:03/94/040/00101/AM16/
30.06.2015 recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/352/2015-PI(Norms) dated Nov..2015 , uploaded along with these minutes or as applied by the firm whichever is less

443

Case No.:44/7/82-

ALC4/2015
Party Name:LEE PHARMA LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00649/AM16/
RLA File :09/24/040/00201/AM16/
Lic.No/Date:0910062263 30.06.2015 Defer Date:30.12.2015

444

Case No.:42/7/82-

ALC4/2015
Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00647/AM16/
RLA File :31/83/040/00030/AM16/
Lic.No/Date:3110065521 01.07.2015 Defer Date:30.12.2015 DC&PC(Chemicals).

445

Case No.:10/13/82-

ALC4/2015
Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00973/AM16/
RLA File :03/94/040/00229/AM16/
Lic.No/Date:0310797018 02.07.2015 Defer Date:30.12.2015 DC&PC(Chemicals).

446

Case No.:11/13/82-

ALC4/2015
Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00974/AM16/
RLA File :03/94/040/00228/AM16/
Lic.No/Date:0310797020 02.07.2015 Defer Date:30.12.2015 DC&PC(Chemicals).

447

Case No.:39/13/82-

ALC4/2015
Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01002/AM16/
RLA File :03/94/040/00260/AM16/
Lic.No/Date:0310797052 03.07.2015 Defer Date: 14.01.2016

448

Case No.:40/13/82-

ALC4/2015
Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01003/AM16/
RLA File :03/94/040/00259/AM16/
Lic.No/Date:0310797051 03.07.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/67/2015-PI(Norms) dated 16.09.2015 , uploaded along with these minutes or as applied by the firm whichever is less

449

Case No.:24/13/82-

ALC4/2015
Party Name:DANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00987/AM16/
RLA File :03/94/040/00226/AM16/
Lic.No/Date:0310797092 07.07.2015 Defer Date:30.12.2015 DC&PC(Chemicals).

450

Case No.:32/13/82-

ALC4/2015
Party Name:FDC LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00995/AM16/
RLA File :03/94/040/00263/AM16/
Lic.No/Date:0310797090 07.07.2015 Defer Date:30.12.2015

451

Case No.:53/13/82-

ALC4/2015
Party Name:FINE ORGANIC INDUSTRIES PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01016/AM16/
RLA File :03/94/040/00225/AM16/
Lic.No/Date:0310797089 07.07.2015 Defer Date:30.12.2015 DC&PC(Chemicals).

452

Case No.:81/13/82-

ALC4/2015
Party Name:PAB ORGANICS PVT.LTD, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01044/AM16/
RLA File :34/24/040/00083/AM16/
Lic.No/Date:3410041361 07.07.2015 Defer Date: DC&PC(Chemicals).

453

Case No.:82/13/82-

ALC4/2015
Party Name:PAB ORGANICS PVT.LTD, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01045/AM16/
RLA File :34/24/040/00084/AM16/
Lic.No/Date:3410041360 07.07.2015 Defer Date:30.12.2015 DC&PC(Chemicals).

454

Case No.:104/8/82-

ALC4/2015
Party Name:POLYDRUG LABORATORIES PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00900/AM16/
RLA File :03/95/040/00219/AM16/
Lic.No/Date:0310797101 07.07.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/415/2015-PI(Norms)

455

Case No.:2/7/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00607/AM16/
RLA File :09/24/040/00213/AM16/
Lic.No/Date:0910062316 08.07.2015 Defer Date:30.12.2015

456

Case No.:103/8/82-

ALC4/2015
Party Name:SUNSHIELD CHEMICALS LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00899/AM16/
RLA File :03/95/040/00266/AM16/
Lic.No/Date:0310797135 09.07.2015 Defer Date:30.12.2015 DC&PC(Chemicals).

457

Case No.:9/13/82-

ALC4/2015
Party Name:DORF- KETAL CHEMICALS INDIA PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00972/AM16/
RLA File :03/94/040/00176/AM16/
Lic.No/Date:0310797178 13.07.2015 Defer Date:30.12.2015 DC&PC(Chemicals).

458

Case No.:12/13/82-

ALC4/2015
Party Name:ALKYL AMINES CHEMICALS LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00975/AM16/
RLA File :03/94/040/00003/AM16/
Lic.No/Date:0310797246 15.07.2015 Defer Date:30.12.2015 DC&PC(Chemicals).

459

Case No.:13/13/82-

ALC4/2015
Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00976/AM16/
RLA File :03/94/040/00232/AM16/
Lic.No/Date:0310797262 15.07.2015 Defer Date: Decision : The Committee decided to defer the case for want of comments of DC&PC (Chemicals).

460 Case No.:14/13/82- ALC4/2015
Party Name:DORF- KETAL CHEMICALS Meet No/Date:13/82- ALC4/2015 Status:Case Deferred

INDIA PVT.LTD. 27.11.2015 HQ File :01/82/050/00977/AM16/
RLA File :03/94/040/00221/AM16/
Lic.No/Date:0310797252 15.07.2015 Defer Date:30.12.2015 DC&PC(Chemicals).

461

Case No.:23/13/82-

ALC4/2015
Party Name:K V AROCHEM PVT. LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00986/AM16/
RLA File :03/94/040/00284/AM16/
Lic.No/Date:0310797268 15.07.2015 Defer Date:30.12.2015 DC&PC(Chemicals).

462

Case No.:22/13/82-

ALC4/2015
Party Name:BLISS INDASI LIFESCIENCES PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00985/AM16/
RLA File :03/94/040/00282/AM16/
Lic.No/Date:0310797355 17.07.2015 Defer Date:30.12.2015 Decision : The Committee decided to send a copy of application to DoP.

463

Case No.:73/13/82-

ALC4/2015
Party Name:KLJ PLASTICIZERS LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01036/AM16/
RLA File :05/23/040/00157/AM16/
Lic.No/Date:0510394996 20.07.2015 Defer Date: recommendation of D/o C&PC, forwarded vide U.O.No.14010/36/2011-CH-II dated 19.10.2015 ,

464

Case No.:105/13/82-

ALC4/2015
Party Name:ALTA LABORATORIES LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01068/AM16/
RLA File :03/94/040/00174/AM16/
Lic.No/Date:0310797472 21.07.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/228/2013-PI(Norms) dated 3.7.2013, uploaded along with these minutes or as applied by the firm whichever is less

465

Case No.:185/7/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00790/AM16/
RLA File :09/24/040/00219/AM16/
Lic.No/Date:0910062355 21.07.2015 Defer Date:30.12.2015

466

Case No.:169/13/82-

ALC4/2015
Party Name:VASUDHA PHARMA CHEM LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved

HQ File :01/82/050/01132/AM16/
RLA File :09/24/040/00177/AM16/
Lic.No/Date:0910062350 21.07.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/798/2013-PI(Norms) dated Sept. 2014, uploaded along with these minutes or as applied by the firm whichever is less

467

Case No.:93/13/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01056/AM16/
RLA File :03/94/040/00303/AM16/
Lic.No/Date:0310797532 22.07.2015 Defer Date:30.12.2015

468

Case No.:94/13/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01057/AM16/
RLA File :03/94/040/00297/AM16/
Lic.No/Date:0310797529 22.07.2015 Defer Date:30.12.2015

469

Case No.:131/13/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01094/AM16/
RLA File :03/94/040/00302/AM16/
Lic.No/Date:0310797531 22.07.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/504/2015-PI(Norms) dated 18.10.2015 , uploaded along with these minutes or as applied by the firm whichever is less

470

Case No.:80/8/82-

ALC4/2015
Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00876/AM16/
RLA File :05/24/040/00192/AM16/
Lic.No/Date:0510395055 23.07.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/141/2015-PI(Norms) dated Oct. 2015 , uploaded along with these minutes or as applied by the firm whichever is less

471

Case No.:119/8/82-

ALC4/2015
Party Name:SI GROUP INDIA LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00915/AM16/
RLA File :03/95/040/00322/AM16/
Lic.No/Date:0310797595 23.07.2015 Defer Date:30.12.2015

472

Case No.:98/13/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred

HQ File :01/82/050/01061/AM16/
RLA File :03/94/040/00313/AM16/
Lic.No/Date:0310797651 24.07.2015 Defer Date:30.12.2015

473

Case No.:99/13/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01062/AM16/
RLA File :03/94/040/00312/AM16/
Lic.No/Date:0310797650 24.07.2015 Defer Date:30.12.2015

474

Case No.:103/13/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01066/AM16/
RLA File :03/94/040/00307/AM16/
Lic.No/Date:0310797639 24.07.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/505/2012-PI(Norms) dated 18.10.2015 , uploaded along with these minutes or as applied by the firm whichever is less

475

Case No.:132/13/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01095/AM16/
RLA File :03/94/040/00298/AM16/
Lic.No/Date:0310797652 24.07.2015 Defer Date:30.12.2015

476

Case No.:133/13/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01096/AM16/
RLA File :03/94/040/00306/AM16/
Lic.No/Date:0310797633 24.07.2015 Defer Date:30.12.2015

477

Case No.:134/13/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01097/AM16/
RLA File :03/94/040/00308/AM16/
Lic.No/Date:0310797640 24.07.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/504/2015-PI(Norms)

478

Case No.:115/13/82-

ALC4/2015
Party Name:FERMENTA BIOTECH LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01078/AM16/
RLA File :03/94/040/00038/AM16/
Lic.No/Date:0310797627 24.07.2015 Defer Date:30.12.2015

479

Case No.:97/13/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01060/AM16/
RLA File :03/94/040/00327/AM16/
Lic.No/Date:0310797799 29.07.2015 Defer Date:30.12.2015

480

Case No.:100/13/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01063/AM16/
RLA File :03/94/040/00328/AM16/
Lic.No/Date:0310797802 29.07.2015 Defer Date:30.12.2015

481

Case No.:101/13/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01064/AM16/
RLA File :03/94/040/00333/AM16/
Lic.No/Date:0310797805 29.07.2015 Defer Date:30.12.2015

482

Case No.:117/13/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01080/AM16/
RLA File :03/94/040/00323/AM16/
Lic.No/Date:0310797801 29.07.2015 Defer Date:30.12.2015

483

Case No.:118/13/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01081/AM16/
RLA File :03/94/040/00332/AM16/
Lic.No/Date:0310797803 29.07.2015 Defer Date:30.12.2015

484

Case No.:119/13/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01082/AM16/
RLA File :03/94/040/00309/AM16/
Lic.No/Date:0310797783 29.07.2015 Defer Date:30.12.2015

485

Case No.:69/13/82-

ALC4/2015
Party Name:PI INDUSTRIES LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01032/AM16/
RLA File :13/24/040/00016/AM16/
Lic.No/Date:1310047933 29.07.2015 Defer Date:30.12.2015

486

Case No.:37/8/82-

ALC4/2015
Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00833/AM16/
RLA File :05/23/040/00183/AM16/
Lic.No/Date:0510395134 30.07.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/224/2015-PI(Norms) dated Sept. 2015 , uploaded along with these minutes or as applied by the firm whichever is less

487

Case No.:92/13/82-

ALC4/2015
Party Name:INFINITY LABORATORIES PVT.LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01055/AM16/
RLA File :22/24/040/00027/AM16/
Lic.No/Date:2210015273 31.07.2015 Defer Date:30.12.2015

488

Case No.:116/13/82-

ALC4/2015
Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01079/AM16/
RLA File :03/94/040/00215/AM16/
Lic.No/Date:0310797864 31.07.2015 Defer Date:30.12.2015

489

Case No.:114/13/82-

ALC4/2015
Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01077/AM16/
RLA File :03/94/040/00258/AM16/
Lic.No/Date:0310797898 03.08.2015 Defer Date:30.12.2015

490

Case No.:113/13/82-

ALC4/2015
Party Name:K V AROCHEM PVT. LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01076/AM16/
RLA File :03/94/040/00335/AM16/
Lic.No/Date:0310797897 03.08.2015 Defer Date:30.12.2015

491

Case No.:104/13/82-

ALC4/2015
Party Name:ALTA LABORATORIES LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01067/AM16/
RLA File :03/94/040/00288/AM16/
Lic.No/Date:0310797922 04.08.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/228/2013-PI(Norms) dated 3.7.2013, uploaded along with these minutes or as applied by the firm whichever is less

492

Case No.:112/13/82-

ALC4/2015
Party Name:K V AROCHEM PVT. LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred

HQ File :01/82/050/01075/AM16/
RLA File :03/94/040/00345/AM16/
Lic.No/Date:0310797937 04.08.2015 Defer Date:30.12.2015

493

Case No.:75/13/82-

ALC4/2015
Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01038/AM16/
RLA File :05/24/040/00215/AM16/
Lic.No/Date:0510395160 04.08.2015 Defer Date:30.12.2015

494

Case No.:78/13/82-

ALC4/2015
Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01041/AM16/
RLA File :05/24/040/00219/AM16/
Lic.No/Date:0510395169 04.08.2015 Defer Date:30.12.2015

495

Case No.:51/13/82-

ALC4/2015
Party Name:ALCHYMARS ICM SM PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01014/AM16/
RLA File :04/24/040/00075/AM16/
Lic.No/Date:0410160875 05.08.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/649/2015-PI(Norms) dated May.2015 , uploaded along with these minutes or as applied by the firm whichever is less

496

Case No.:109/13/82-

ALC4/2015
Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01072/AM16/
RLA File :03/94/040/00170/AM16/
Lic.No/Date:0310797954 05.08.2015 Defer Date:30.12.2015

497

Case No.:50/13/82-

ALC4/2015
Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01013/AM16/
RLA File :04/24/040/00095/AM16/
Lic.No/Date:0410160884 06.08.2015 Defer Date:30.12.2015

498

Case No.:108/13/82-

ALC4/2015
Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01071/AM16/
RLA File :03/94/040/00150/AM16/
Lic.No/Date:0310798022 07.08.2015 Defer Date:30.12.2015

499 Case No.:166/13/82- Party Meet No/Date:13/82- Status:Case

ALC4/2015
Name:PARAMOUNT AROMACHEM PVT.LTD., ALC4/2015 27.11.2015 Deferred HQ File :01/82/050/01129/AM16/
RLA File :05/24/040/00235/AM16/
Lic.No/Date:0510395245 07.08.2015 Defer Date:30.12.2015

500

Case No.:68/13/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01031/AM16/
RLA File :05/24/040/00230/AM16/
Lic.No/Date:0510395244 07.08.2015 Defer Date:30.12.2015

501

Case No.:107/13/82-

ALC4/2015
Party Name:DANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01070/AM16/
RLA File :03/94/040/00299/AM16/
Lic.No/Date:0310798050 10.08.2015 Defer Date:30.12.2015

502

Case No.:80/13/82-

ALC4/2015
Party Name:ARIHANTANAM LIFECARE PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01043/AM16/
RLA File :52/24/040/00030/AM16/
Lic.No/Date:5210041602 12.08.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/496/2013-PI(Norms) dated 21.11.2015 , uploaded along with these minutes or as applied by the firm whichever is less

503

Case No.:6/13/82-

ALC4/2015
Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00969/AM16/
RLA File :31/83/040/00066/AM16/
Lic.No/Date:3110065596 12.08.2015 Defer Date:30.12.2015

504

Case No.:110/13/82-

ALC4/2015
Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01073/AM16/
RLA File :03/94/040/00350/AM16/
Lic.No/Date:0310798096 12.08.2015 Defer Date:30.12.2015

505

Case No.:106/13/82-

ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01069/AM16/
RLA File :03/94/040/00379/AM16/
Lic.No/Date:0310798101 12.08.2015 Defer Date:30.12.2015

506

Case No.:111/13/82-

ALC4/2015
Party Name:HEMA DYE CHEM PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01074/AM16/
RLA File :03/94/040/00305/AM16/
Lic.No/Date:0310798134 13.08.2015 Defer Date:30.12.2015

507

Case No.:102/13/82-

ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01065/AM16/
RLA File :03/94/040/00384/AM16/
Lic.No/Date:0310798136 13.08.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/290/2015-PI(Norms) dated November 2015 , uploaded along with these minutes or as applied by the firm whichever is NC.

508

Case No.:91/13/82-

ALC4/2015
Party Name:VENUS REMEDIES LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01054/AM16/
RLA File :22/24/040/00016/AM16/
Lic.No/Date:2210015282 13.08.2015 Defer Date:30.12.2015

509

Case No.:79/13/82-

ALC4/2015
Party Name:AMI ORGANICS PVT LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01042/AM16/
RLA File :52/24/040/00034/AM16/
Lic.No/Date:5210041610 14.08.2015 Defer Date:30.12.2015

510

Case No.:58/13/82-

ALC4/2015
Party Name:G.G.CHEMICALS & PHARMACEUTICALS PVT.LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01021/AM16/
RLA File :22/24/040/00031/AM16/
Lic.No/Date:2210015283 14.08.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/226/2015-PI(Norms) dated September 2015 , uploaded along with 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.

511

Case No.:57/13/82-

ALC4/2015
Party Name:VENUS REMEDIES LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01020/AM16/
RLA File :22/24/040/00013/AM16/
Lic.No/Date:2210015284 14.08.2015 Defer Date:30.12.2015

512

Case No.:52/13/82-

ALC4/2015
Party Name:ARGO BIOCHEM PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01015/AM16/
RLA File :03/94/040/00300/AM16/
Lic.No/Date:0310798204 17.08.2015 Defer Date:30.12.2015

513

Case No.:127/13/82-

ALC4/2015
Party Name:ASTEC LIFESCIENCES LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01090/AM16/
RLA File :03/94/040/00878/AM15/
Lic.No/Date:0310798205 17.08.2015 Defer Date:30.12.2015

514

Case No.:60/13/82-

ALC4/2015
Party Name:HELLO PAINTS (P) LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01023/AM16/
RLA File :05/23/040/00204/AM16/
Lic.No/Date:0510395351 18.08.2015 Defer Date:30.12.2015

515

Case No.:90/13/82-

ALC4/2015
Party Name:INDO PHYTO CHEMICALS PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01053/AM16/
RLA File :05/23/040/00195/AM16/
Lic.No/Date:0510395344 18.08.2015 Defer Date:30.12.2015

516

Case No.:56/13/82-

ALC4/2015
Party Name:PANACEA BIOTEC LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01019/AM16/
RLA File :05/24/040/00183/AM16/
Lic.No/Date:0510395354 18.08.2015 Defer Date: 14.01.2016 Decision : The Committee decided to defer the case for want of comments of DBT.

517

Case No.:65/13/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01028/AM16/
RLA File :05/24/040/00149/AM16/
Lic.No/Date:0510395338 18.08.2015 Defer Date:30.12.2015

518

Case No.:66/13/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01029/AM16/
RLA File :05/24/040/00118/AM16/
Lic.No/Date:0510395337 18.08.2015 Defer Date:30.12.2015

519

Case No.:67/13/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01030/AM16/
RLA File :05/24/040/00172/AM16/
Lic.No/Date:0510395339 18.08.2015 Defer Date:30.12.2015

520

Case No.:89/13/82-

ALC4/2015
Party Name:INDO PHYTOCHEM PHARMACEUTICALS Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01052/AM16/
RLA File :05/23/040/00211/AM16/
Lic.No/Date:0510395366 19.08.2015 Defer Date:30.12.2015

521

Case No.:59/13/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Added HQ File :01/82/050/01022/AM16/
RLA File :05/24/040/00605/AM15/
Lic.No/Date:0510395358 19.08.2015 Defer Date:

522

Case No.:63/13/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01026/AM16/
RLA File :05/24/040/00606/AM15/
Lic.No/Date:0510395359 19.08.2015 Defer Date:30.12.2015

523

Case No.:64/13/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01027/AM16/
RLA File :05/24/040/00618/AM15/
Lic.No/Date:0510395374 19.08.2015 Defer Date:30.12.2015

524

Case No.:87/13/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01050/AM16/
RLA File :05/24/040/00612/AM15/
Lic.No/Date:0510395362 19.08.2015 Defer Date:30.12.2015

525

Case No.:88/13/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01051/AM16/
RLA File :05/24/040/00025/AM16/
Lic.No/Date:0510395364 19.08.2015 Defer Date:30.12.2015

526

Case No.:126/13/82-

ALC4/2015
Party Name:ASTEC LIFESCIENCES LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01089/AM16/
RLA File :03/94/040/00879/AM15/
Lic.No/Date:0310798319 20.08.2015 Defer Date:30.12.2015

527

Case No.:61/13/82-

ALC4/2015
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01024/AM16/
RLA File :05/23/040/00218/AM16/
Lic.No/Date:0510395388 20.08.2015 Defer Date:30.12.2015

528

Case No.:62/13/82-

ALC4/2015
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01025/AM16/
RLA File :05/23/040/00212/AM16/
Lic.No/Date:0510395383 20.08.2015 Defer Date:30.12.2015

529

Case No.:72/13/82-

ALC4/2015
Party Name:AMI ORGANICS PVT LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01035/AM16/
RLA File :52/24/040/00036/AM16/
Lic.No/Date:5210041615 21.08.2015 Defer Date:30.12.2015

530

Case No.:161/13/82-

ALC4/2015
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01124/AM16/
RLA File :03/95/040/00274/AM16/
Lic.No/Date:0310798374 21.08.2015 Defer Date:30.12.2015

531

Case No.:125/13/82-

ALC4/2015
Party Name:FDC LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01088/AM16/
RLA File :03/94/040/00364/AM16/
Lic.No/Date:0310798396 24.08.2015 Defer Date:30.12.2015

532

Case No.:130/13/82-

ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01093/AM16/
RLA File :03/94/040/00413/AM16/
Lic.No/Date:0310798392 24.08.2015 Defer Date:30.12.2015

533

Case No.:85/13/82-

ALC4/2015
Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01048/AM16/
RLA File :05/23/040/00198/AM16/
Lic.No/Date:0510395430 25.08.2015 Defer Date:30.12.2015

534

Case No.:86/13/82-

ALC4/2015
Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01049/AM16/
RLA File :05/23/040/00200/AM16/
Lic.No/Date:0510395431 25.08.2015 Defer Date:30.12.2015

535

Case No.:54/13/82-

ALC4/2015
Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01017/AM16/
RLA File :03/94/040/00089/AM16/
Lic.No/Date:0310798493 26.08.2015 Defer Date:30.12.2015

536

Case No.:129/13/82-

ALC4/2015
Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01092/AM16/
RLA File :03/94/040/00336/AM16/
Lic.No/Date:0310798491 26.08.2015 Defer Date:30.12.2015

537

Case No.:77/13/82-

ALC4/2015
Party Name:ARKRAY HEALTHCARE PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01040/AM16/
RLA File :52/24/040/00038/AM16/
Lic.No/Date:5210041620 27.08.2015 Defer Date:30.12.2015

538

Case No.:121/13/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01084/AM16/
RLA File :03/94/040/00406/AM16/
Lic.No/Date:0310798528 27.08.2015 Defer Date:30.12.2015 Decision :Information for the export product has already been called for from the firm and same has not been received so far. The Committee decided to await the reply and deferred the case.

539

Case No.:122/13/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01085/AM16/
RLA File :03/94/040/00408/AM16/
Lic.No/Date:0310798530 27.08.2015 Defer Date:30.12.2015

Decision : Information for the export product has already been called for from the firm and same has not been received so far. The Committee decided to await the reply and deferred the case.

540

Case No.:76/13/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01039/AM16/
RLA File :05/24/040/00253/AM16/
Lic.No/Date:0510395455 27.08.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/412/2014-PI(Norms) dated 21.01.2015, uploaded along with these minutes or as applied by the firm whichever is less

541

Case No.:74/13/82-

ALC4/2015
Party Name:KLJ PLASTICIZERS LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01037/AM16/
RLA File :05/23/040/00201/AM16/
Lic.No/Date:0510395469 28.08.2015 Defer Date:30.12.2015

542

Case No.:128/13/82-

ALC4/2015
Party Name:ALKYL AMINES CHEMICALS LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01091/AM16/
RLA File :03/94/040/01129/AM15/
Lic.No/Date:0310798586 31.08.2015 Defer Date:30.12.2015

543

Case No.:123/13/82-

ALC4/2015
Party Name:GUJARAT ORGANICS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01086/AM16/
RLA File :03/94/040/00247/AM16/
Lic.No/Date:0310798598 01.09.2015 Defer Date:30.12.2015

544

Case No.:124/13/82-

ALC4/2015
Party Name:GUJARAT ORGANICS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01087/AM16/
RLA File :03/94/040/00246/AM16/
Lic.No/Date:0310798597 01.09.2015 Defer Date:30.12.2015

545

Case No.:120/13/82-

ALC4/2015
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01083/AM16/
RLA File :03/94/040/00279/AM16/
Lic.No/Date:0310798629 03.09.2015 Defer Date:30.12.2015

546 Case No.:95/13/82- Party Name:CLEAN Meet No/Date:13/82- Status:Case

ALC4/2015
SCIENCE AND TECHNOLOGY PVT.LTD. ALC4/2015 27.11.2015 Approved HQ File :01/82/050/01058/AM16/
RLA File :31/83/040/00079/AM16/
Lic.No/Date:3110065625 08.09.2015 Defer Date:
Decision : The Committee decided to ratify norms for the export product based on the recommendation of D/o C&PC, forwarded vide U.O.No.14010/3/2012-Ch-II dated 22.6.2015, uploaded along with 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.

547

Case No.:96/13/82-

ALC4/2015
Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01059/AM16/
RLA File :31/83/040/00080/AM16/
Lic.No/Date:3110065626 08.09.2015 Defer Date:30.12.2015

548

Case No.:7/9/82-

ALC4/2015
Party Name:DR REDDYS LABORATORIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00943/AM16/
RLA File :09/24/040/00312/AM16/
Lic.No/Date:0910062574 08.09.2015 Defer Date:30.12.2015

549

Case No.:3/9/82-

ALC4/2015
Party Name:HETERO DRUGS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00939/AM16/
RLA File :09/24/040/00341/AM16/
Lic.No/Date:0910062565 08.09.2015 Defer Date:30.12.2015

550

Case No.:4/9/82-

ALC4/2015
Party Name:HETERO DRUGS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00940/AM16/
RLA File :09/24/040/00338/AM16/
Lic.No/Date:0910062566 08.09.2015 Defer Date:30.12.2015

551

Case No.:5/9/82-

ALC4/2015
Party Name:HETERO DRUGS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00941/AM16/
RLA File :09/24/040/00337/AM16/
Lic.No/Date:0910062567 08.09.2015 Defer Date:30.12.2015

552 Case No.:2/9/82- ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 Status:Case Deferred

27.11.2015 HQ File :01/82/050/00938/AM16/
RLA File :09/24/040/00344/AM16/
Lic.No/Date:0910062564 08.09.2015 Defer Date:30.12.2015

553

Case No.:172/13/82-

ALC4/2015
Party Name:LAKE CHEMICALS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01135/AM16/
RLA File :07/24/040/00201/AM16/
Lic.No/Date:0710108696 08.09.2015 Defer Date: 14.01.2016 Decision : The Committee decided to defer the case for want of comments of DoP.

554

Case No.:8/9/82-

ALC4/2015
Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00944/AM16/
RLA File :34/24/040/00155/AM16/
Lic.No/Date:3410041496 09.09.2015 Defer Date:30.12.2015

555

Case No.:10/9/82-

ALC4/2015
Party Name:ALKYL AMINES CHEMICALS LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00946/AM16/
RLA File :03/94/040/00355/AM16/
Lic.No/Date:0310798806 10.09.2015 Defer Date:30.12.2015

556

Case No.:170/13/82-

ALC4/2015
Party Name:VINDHYA ORGANICS PVT LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01133/AM16/
RLA File :09/24/040/00358/AM16/
Lic.No/Date:0910062596 11.09.2015 Defer Date:30.12.2015

557

Case No.:12/9/82-

ALC4/2015
Party Name:ALKYL AMINES CHEMICALS LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00948/AM16/
RLA File :03/94/040/00372/AM16/
Lic.No/Date:0310798878 14.09.2015 Defer Date:30.12.2015

558

Case No.:16/9/82-

ALC4/2015
Party Name:ALKYL AMINES CHEMICALS LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00952/AM16/
RLA File :03/94/040/00265/AM16/
Lic.No/Date:0310798923 16.09.2015 Defer Date:30.12.2015

559 Case No.:18/9/82- ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 Status:Case Deferred

27.11.2015 HQ File :01/82/050/00954/AM16/
RLA File :09/24/040/00368/AM16/
Lic.No/Date:0910062629 16.09.2015 Defer Date:30.12.2015

560

Case No.:19/9/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00955/AM16/
RLA File :09/24/040/00369/AM16/
Lic.No/Date:0910062630 16.09.2015 Defer Date:30.12.2015

561

Case No.:17/9/82-

ALC4/2015
Party Name:HONOUR LAB LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00953/AM16/
RLA File :09/24/040/00371/AM16/
Lic.No/Date:0910062628 16.09.2015 Defer Date:30.12.2015

562

Case No.:173/13/82-

ALC4/2015
Party Name:LAKE CHEMICALS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01136/AM16/
RLA File :07/24/040/00200/AM16/
Lic.No/Date:0710108760 22.09.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/249/2015-PI(Norms) dated Sept.2015 , uploaded along with these minutes or as applied by the firm whichever is less

563

Case No.:20/9/82-

ALC4/2015
Party Name:SUPREET CHEMICALS PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00956/AM16/
RLA File :03/95/040/00424/AM16/
Lic.No/Date:0310798995 22.09.2015 Defer Date:30.12.2015

564

Case No.:4/13/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00967/AM16/
RLA File :09/24/040/00391/AM16/
Lic.No/Date:0910062720 13.10.2015 Defer Date:30.12.2015

565

Case No.:5/13/82-

ALC4/2015
Party Name:DIVIS LABORATORIES LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/00968/AM16/
RLA File :09/24/040/00403/AM16/
Lic.No/Date:0910062721 13.10.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/634/2015-PI(Norms)

dated May.2015 , uploaded along with these minutes or as applied by the firm whichever is less

566

Case No.:3/13/82-

ALC4/2015
Party Name:HETERO DRUGS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00966/AM16/
RLA File :09/24/040/00432/AM16/
Lic.No/Date:0910062716 13.10.2015 Defer Date:30.12.2015

567

Case No.:1/13/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00964/AM16/
RLA File :09/24/040/00435/AM16/
Lic.No/Date:0910062713 13.10.2015 Defer Date:30.12.2015

568

Case No.:2/13/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/00965/AM16/
RLA File :09/24/040/00436/AM16/
Lic.No/Date:0910062714 13.10.2015 Defer Date:30.12.2015

569

Case No.:135/13/82-

ALC4/2015
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01098/AM16/
RLA File :09/24/040/00408/AM16/
Lic.No/Date:0910062740 14.10.2015 Defer Date:30.12.2015

570

Case No.:136/13/82-

ALC4/2015
Party Name:ATUL LIMITED, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01099/AM16/
RLA File :08/24/040/00207/AM16/
Lic.No/Date:0810136320 16.10.2015 Defer Date:30.12.2015

571

Case No.:138/13/82-

ALC4/2015
Party Name:ARCHIMEDIS LABORATORIES PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01101/AM16/
RLA File :09/24/040/00320/AM16/
Lic.No/Date:0910062756 20.10.2015 Defer Date:30.12.2015

572

Case No.:137/13/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File RLA File Lic.No/Date:0910062755 Defer

:01/82/050/01100/AM16/ :09/24/040/00450/AM16/ 20.10.2015 Date:30.12.2015

573

Case No.:139/13/82-

ALC4/2015
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01102/AM16/
RLA File :03/95/040/00456/AM16/
Lic.No/Date:0310799558 20.10.2015 Defer Date:30.12.2015

574

Case No.:140/13/82-

ALC4/2015
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01103/AM16/
RLA File :03/95/040/00503/AM16/
Lic.No/Date:0310799583 21.10.2015 Defer Date:30.12.2015

575

Case No.:168/13/82-

ALC4/2015
Party Name:SYNERGENE ACTIVE INGREDIENTS PVT LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01131/AM16/
RLA File :09/24/040/00426/AM16/
Lic.No/Date:0910062765 21.10.2015 Defer Date:30.12.2015

576

Case No.:141/13/82-

ALC4/2015
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01104/AM16/
RLA File :03/95/040/00504/AM16/
Lic.No/Date:0310799629 23.10.2015 Defer Date:30.12.2015

577

Case No.:142/13/82-

ALC4/2015
Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01105/AM16/
RLA File :09/24/040/00443/AM16/
Lic.No/Date:0910062774 27.10.2015 Defer Date:30.12.2015

578

Case No.:144/13/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status: Deferred
HQ File :01/82/050/01107/AM16/
RLA File :09/24/040/00387/AM16/
Lic.No/Date:0910062780 28.10.2015 Defer Date:30.12.2015

579

Case No.:145/13/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File RLA File Lic.No/Date:0910062781 Defer

:01/82/050/01108/AM16/ :09/24/040/00396/AM16/ 28.10.2015 Date:30.12.2015

580

Case No.:146/13/82-

ALC4/2015
Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01109/AM16/
RLA File :09/24/040/00413/AM16/
Lic.No/Date:0910062785 28.10.2015 Defer Date:30.12.2015

581

Case No.:143/13/82-

ALC4/2015
Party Name:HETERO DRUGS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01106/AM16/
RLA File :09/24/040/00457/AM16/
Lic.No/Date:0910062776 28.10.2015 Defer Date:30.12.2015

582

Case No.:147/13/82-

ALC4/2015
Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01110/AM16/
RLA File :08/24/040/00241/AM16/
Lic.No/Date:0810136382 29.10.2015 Defer Date:30.12.2015

583

Case No.:148/13/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01111/AM16/
RLA File :09/24/040/00465/AM16/
Lic.No/Date:0910062798 29.10.2015 Defer Date:30.12.2015

584

Case No.:149/13/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01112/AM16/
RLA File :09/24/040/00466/AM16/
Lic.No/Date:0910062799 29.10.2015 Defer Date:30.12.2015

585

Case No.:150/13/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01113/AM16/
RLA File :09/24/040/00467/AM16/
Lic.No/Date:0910062800 29.10.2015 Defer Date:30.12.2015

586

Case No.:152/13/82-

ALC4/2015
Party Name:ARCHIMEDIS LABORATORIES PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File RLA File Lic.No/Date:0910062806 Defer

:01/82/050/01115/AM16/ :09/24/040/00319/AM16/ 30.10.2015 Date:30.12.2015

587

Case No.:151/13/82-

ALC4/2015
Party Name:DIVIS LABORATORIES LTD., Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Approved HQ File :01/82/050/01114/AM16/
RLA File :09/24/040/00439/AM16/
Lic.No/Date:0910062803 30.10.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/133/2015-PI(Norms) dated 11.09.2015 , uploaded along with these minutes or as applied by the firm whichever is less

588

Case No.:153/13/82-

ALC4/2015
Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01116/AM16/
RLA File :34/24/040/00199/AM16/
Lic.No/Date:3410041644 02.11.2015 Defer Date:30.12.2015

589

Case No.:154/13/82-

ALC4/2015
Party Name:DR REDDYS LABORATORIES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01117/AM16/
RLA File :09/24/040/00460/AM16/
Lic.No/Date:0910062821 03.11.2015 Defer Date:30.12.2015

590

Case No.:155/13/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01118/AM16/
RLA File :09/24/040/00475/AM16/
Lic.No/Date:0910062827 03.11.2015 Defer Date:30.12.2015

591

Case No.:156/13/82-

ALC4/2015
Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01119/AM16/
RLA File :09/24/040/00464/AM16/
Lic.No/Date:0910062832 03.11.2015 Defer Date:30.12.2015

592

Case No.:159/13/82-

ALC4/2015
Party Name:CHEMCON SPECIALITY CHEMICALS P LTD Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01122/AM16/
RLA File :34/24/040/00205/AM16/
Lic.No/Date:3410041650 04.11.2015 Defer Date:30.12.2015

593 Case No.:157/13/82- ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 Status:Case Deferred

27.11.2015 HQ File :01/82/050/01120/AM16/
RLA File :09/24/040/00476/AM16/
Lic.No/Date:0910062833 04.11.2015 Defer Date:30.12.2015

594

Case No.:158/13/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01121/AM16/
RLA File :09/24/040/00477/AM16/
Lic.No/Date:0910062834 04.11.2015 Defer Date:30.12.2015

595

Case No.:163/13/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01126/AM16/
RLA File :09/24/040/00479/AM16/
Lic.No/Date:0910062838 06.11.2015 Defer Date:30.12.2015

596

Case No.:162/13/82-

ALC4/2015
Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01125/AM16/
RLA File :09/24/040/00427/AM16/
Lic.No/Date:0910062836 06.11.2015 Defer Date:30.12.2015

597

Case No.:165/13/82-

ALC4/2015
Party Name:ATUL LIMITED, Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01128/AM16/
RLA File :52/24/040/00050/AM16/
Lic.No/Date:5210041688 12.11.2015 Defer Date:30.12.2015

598

Case No.:167/13/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01130/AM16/
RLA File :09/24/040/00493/AM16/
Lic.No/Date:0910062862 19.11.2015 Defer Date:30.12.2015

599

Case No.:171/13/82-

ALC4/2015
Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:13/82- ALC4/2015 27.11.2015 Status:Case Deferred HQ File :01/82/050/01134/AM16/
RLA File :09/24/040/00497/AM16/
Lic.No/Date:0910062889 24.11.2015 Defer Date:30.12.2015

Manual Agenda of NC Meeting No. 13/82/2015 Scheduled to be held on 27.11.2015

Case No. B- 01

M.No.13/16 Date 27.11.2015

M/s. Encube Ethicals Pvt Ltd. File No. 01/82/050/00380/AM-13 RLA No.09/94/040/0053/AM-13 Adv.Auth. No. 0310692961 dated 5.2.2012 Decision: The Committee considered the case for revision of Norms under Para 4.07 of HBP as per agenda. The Committee decided to defer the case for want of comments of MSME.

Case No. B- 02

M.No.13/16 Date 27.11.2015

The Indian Drug manufacturer Association Ahmedabad File No.01/82/162/151/AM16 Decision: The Committee considered the case for revision of SION A-412, A-207, A0205, A-206 as per agenda. A reference has been forwarded to DoP on 2.12.2015. Comments of DoP is awaited.

Case No. B- 03

M.No.13/16 Date 27.11.2015

The Pharmaceuticals Exports Promotion Council of India File No.01/82/162/151/AM16 Decision: The Committee considered the case for fixation of 45 new SION for various Pharmaceuticals formulations as per agenda.

The Committee in light of recommendation forwarded by D/o Pharmaceuticals vide O.M.No.35011/75/2015- PI(Norms) dated 03.12.2015 & 11.12.2015 decided to publish new SION for 33 export products of various Pharmaceuticls formulations as per detais given below:-

Sl. No. Export Item Import Item Description Qty. Description
Quantity proposed by Pharmexcil Quantity worked out by DoP (upto) (1) (2) (3) (4) (5) (6) 1 Alendronate Sodium Tablets 70 mg (Each Tablet contains Alendronate Sodium equivalent to 70 mg Alendronic acid) 1000 Tablet s Alendronate Sodium Trihydrate 111.741 gm 93.152 gm 2 AmikacinSulphate Injection 500 mg/2ml (Each 2 ml vial contains AmikacinSulphate equivalent to Amikacin 500 mg} 1000 vials AmikacinSulpha te 1011.87gm 715.81 gm 3 Amoxicillin and Potassium Clavunate 1000 mg tablets (Each tablet contains Amoxicillin Trihydrate equivalent to Amoxicillin 875 mg and Potassium Clavulanate equivalent to Clavulanic acid 125 mg)

1000 Tablet s 1) Amoxicillin Trihydrate 1170.654 gm 1024.238
gm 2) Diluted Clavulanate Potassium (1:1) 303.773 gm 303.773 gm 4 Amoxicillin & Clavulanicacid suspension 228.5 mg/5 ml in 100 ml bottles. 1000 bottles 1 Amoxicillin Trihydrate 4900gm 4200gm

(Each 5 ml contains Amoxicillin
Trihydrate equivalent to Amoxicillin 200 mg and Potassium Clavulanate
equivalent to Clavulanic acid 28.5 mg} 2. Diluted Clavulanate Potassium (1:1) 1414.193 gm 1414.193 gm 5 Ampicillin and Sulbactam 750 mg for injection (each vial contains Ampicillin Sodium equivalent to Ampicillin 500 mg and Sulbactam Sodium equivalent to Salbactam 250 mg} 1000 vials 1) Ampicillin Sodium
61.573 gm 583.77 gm 2) Sulbactam Sodium 334.94 gm 302.22 gm 6 Ampicillin injection 500 mg (each vial contains Ampicillin Sodium equivalent to Ampicillin 500 mg) 1000 vials Ampicillin Sodium
615.74 gm 584.63 gm 7 Atorvastatin Tablets 10 mg(each tablet contains Atorvastatin Calcium Trihydrate equivalent to 10 mg Atorvastatin) 1000 Tablet s Atorvastatin CalcliumTrihydr ate 11.75 gm 11.059 gm 8 Benzylpenicillin Injection 5 Lac units (300 mg)

{each vial contains Benzylpencillin Sodium equivalent to Benzylpencillin 300 mg} 1000 vials Benzylpenicillin Sodium 35.857 gm 35.171 gm 9 Cefadroxil (250 mg) and Potassium Clavulanate (62.5 mg) Dispersible Tablets {each tablet contains cefadroxil monohydrate equivalent to 250 mg Cefadroxil on Anhydrous basis and Clavulanate potassium equivalent to Clavulanic acid 62.5 mg} 1000 Tablet s 1) Cefadroxil monohydrate
269.576 gm 267.622 gm 2) Potassium Clavulanate

160.742 gm 75.943 gm 10. Cefixime for oral suspension 30 ml bottle (each 5 ml contains Cefiximetrihydrate equivalent to Cefixime 50 mg on anhydrous basis} 1000 bottles CefiximeTrihydr ate 357.000 gm 352.508 gm 11 Cefixime Tablets 200 mg (each tablet contains Cefiximetridhydrte equivalent to Cefixime 200 mg on anhydrous basis) 1000 Tab CefiximeTrihydr ate 260.488 gm 228.294 gm 12 CefpodoximeProxetil Tablets 200 mg (each tablet contains CefpodoximeProxetil equivalent to Cefpodoxime 200 mg) 1000 tablets CefpodoximePr oxetil 359.78 gm 266.10 gm 13 Ceftriaxone and Sulbactam for injection. 1.5 g (each vial containing Ceftriaxone Sodium equivalent to Ceftriaxone 1 gm and Salbactam Sodium equivalent to Salbactam 0.50 gm) 1000 vials 1) Ceftrixone Sodium sterile
1623.6 gm As per SION A- 407 2) Sulbactam Sodium sterile 669.88 gm 604.44 gm 14 Cefuroxime Axetil Tablets 500 mg
(each tablet contains Cefuroxime Axetil equivalent to Cefuroxime 500 mg) 1000 Tab Cefuroxime Axetil 767.356 gm 614.878 gm 15 Cefuroxime for injection 750 mg (Each vial contains Cefuroxime Sodium equivalent to Cefuroxime 750 mg) 1000 vials Cefuroxime Sodium
936.5 gm 867.74 gm 16 Cefuroxime for oral suspension 125 mg/ 5 ml in 60 ml bottles {each 5 ml containing Cefuroxime Axetil equivalent to Cefuroxime 125 mg) 1000 bottles Cefuroxime Axetil 1968 gm 1899 gm 17 Citicoline Injection 250 mg /ml (each vial contains Citicoline Sodium equivalent to Citicoline 250 mg) 1000 vials Citicoline Sodium
295.89 gm 287.39 gm 18 Citicoline Capsules 500 mg (each capsule contains citicoline sodium 1000 capsul Citicoline sodium
548.740 gm 532.950 gm

equivalent to Citicoline 500 mg) es 19 Clopidogrel Tab 75 mg ( each tablet contains ClopidogrelBisulphate equivalent to Clopidogrel 75 mg) 1000 Tablet s Clopidogrelbisul phate 101.499 gm 99.814 gm 20 Phenoxy methyl Penicillin potassium for oral suspension 250 mg/ 5 ml in 100 ml bottles (each 5 ml contains Phenoxy methyl penicillin potassium equivalent to phenoxy methyl penicillin 250 mg) 1000 bottles Phenoxy methyl penicillin potassium
5864 gm 5820 gm 21 Erythromycin Stearate for oral suspension 250 mg/5ml in 100 ml bottles {each 5 ml contains Etrythromycin Stearate equivalent to Erythromycin 250 mg) 1000 bottles Erythromycin Stearate 8586.9 gm 7284 gm 22 Levofloxacin Tablets 500 mg (each
tablet contains Levofloxacin hemihydrate equivalent to levofloxacin 500 mg on anhydrous basis ) 1000 Tab Levolfoxacin Hemihydrate
536.173 gm 522.750 gm 23 Meropenem for injection 1 gm ( each vial contains MeropenemTrihydrate equivalent to Meropenem Anhydrous 1 gm) 1000 vials MeropenemTrih ydrate 1716 gm 1255 gm 24 Methyl Prednisolone sodium succinate for injection 500 mg {each vial containing Methyl Prednisolone Sodium Succinate equivalent to Methyl Prednisolone 500 mg} 1000 vials Methyl Prednisolone Sodium Succinate
1532.3 gm 729.30 gm 25 Metronidazole oral suspension 200 mg/5 ml, in 100 ml bottles(each 5 ml suspension contains Metronidazole Benzoate equivalent to 200 mg Metronidazole) 1000 bottles Metronidazole Benzoate
6851 gm 6753 gm 26 Pefloxacin Tablet 400 mg (each tablet contains Pefloxacinmesylate equivalent to Pefloxacin 400 mg) 1000 Tab PefloxacinMesyl ate 623.077 gm 569.731 gm 27 Phenoxymethy Penicillin Potassium tablets 500 mg. {each tablet contains Phenoxymethyl Penicillin Potassium equivalent to Phenoxymethyl Penicillin 500 mg) 1000 Tab Phenoxymethyl Penicillin Potassium 571.843
gm 565.453 gm 28 Piperacillin and Tazobactam

for injection 2.25 gm (each vial contains Piperacillin Sodium equivalent to Piperacillin 2 gms + Tazobactam Sodium equivalent to Tazobactam 0.25 gm) 1000 vials

  1. Piperacillin Sodium
    2292.4 gm 2292.4 gm
  2. Tazobactam Sodium 295.08 gm 295.0 gm 29 Primaquine Phosphate Tablets 2.5 mg (each tablet contains
    PrimaquinePhophate equivalent to Primaquine 2.5 mg) 1000 Tablet s Primaquine Phosphate
    13.566 gm 4.477 gm 30 Rosuvastatin 10 mg Tablets (each tablet contains Rosuvastatin Calcium equivalent to Rosuvastatin 10 mg) 1000 Tablet s Rosuvastatin Calcium
    10.720 gm 10.625 gm 31 Spectinomycin injection 2 gm/vial (each vial containinsSpectinomycin Hydrochloride equivalent to Spectinomycin 2 gm) 1000 vials Spectinomycin Hydrochloride
    5049 gm 3278.00 gm 32 Vancomycin Injection 500 mg (each vial contains Vancomycin Hydrochloride
    1000 vials Vancomycin Hydrochloride 591.05 gm 566.50 gm

equivalent to Vancomycin 500 mg, vial size less than 10ml} 33 Amoxicillin & Potassium Clavulanate
for injection 1.2 g (each vial contains Amoxicillin Sodium equivalent to Amoxicillin 1000 mg and Potassium Clavulanate equivalent to Clavulanic Acid 200 mg} 1000 vials Sterile mixture of Amoxicillin trihydrate& Potassium Clavulanate (5:1) 1427.91 gm 1320 gm


執ギ 90°・\ふ Subject: Ret F.No.14010ノ95/2011-CH― || Government ofindia Ministry Of chemicals and Fertilizers Department of chemicals and Petrochemicals Advance Authorization application from Mノs. Yasho lndustries Pvt. Ltd. for the irnport Of raw materials against the expOrt Of ttetrabenzyl thluram disulfide (TBZTD) (Advance Authorization No. 5210041283 dated 29.10.2014) U.O No.01/82/050/1253/AM15/DES¨ ||1/1341 dated 5.03.2015 M/s.Yasho lndustttes(P)Ltd has submnted present applicalons fOrthe impOrt of raw materials against the expOrt Of Tetrabenzyl thiuram disulfide(TBZTD) The app‖ cation has been exanlined a:Ic」 ll‖:epartment recornrnends the fo‖ owing norrns fOrthe present Advance′ へuthorization apl This issues with the approval of competent authority. (A.K.AGARVVAL) Addl.lndustrial Adviser Tel.No.011-23381430 るヽくヽ

  1. ltem of Export Tetrabenzyl thiuram disulfide 1.DIBENZYLAMINE Deptt.of c&PC U.o.No.14010/95/2011-CH― |l dated 30.4.2015

八 F No.'l4o1o/36i2o1o-cH-1 tf\t" Government of lndia Ministry of Chemicals and Fertilizers Department of Chemicals and petrochemicals 3.゛。 ・い` Subject: Rei 脚∬翼憚購壇韮鷺模善 Rよ脊酬 UO No 01ノ82/050/538/AM16/DES― l‖ノ190 dated 29 06 2015 M/s YASH MSA'AN & .HEMTCALS pw. LTD. has submitted present apprications for the import of raw_fiateriars against the export of METH'L 2- METHOX' 5- SULFAMOYL BENZOATE (MSMB) The application has been examined and the Department recommends the fo[owing norms for the present Advance Authorization application. &CHEMiCALS Of METHYL 2- METHYL 2- METHOxY 5‐ SULFAMOYL BENZOATE (MSMB) l METHYL SALICYLATE This issue with the approval of competent authority. Add恰」 ::↑:1月:I:き| TeL No 011_23381430 Deptt. of C&PC U O No 14010/42/2015-CH■l漏 7102015

′   ・ ´ F . No. 14010t312012-CH-il Government of lndia Ministry of Chemicals and Fertilizers Department of Chemicals and petrochemicals To, M/s. Clean Science and Technology pvt. Shubham, Navin Nagar Road, Dangamner, Ahmednagar, Maharashtra- 422605 Ltd.

Subject: Advance Authorization

Guaiacol g9o/o Purity. Sir, application the import of raw-materials against the export of Shastri Bhavan, New Delhi-l 1OOO1 Dated: 3.l"r,July , 2015 I am directed to refer to your Advance Authorization application received through office of DGFT on the subject mentioned above. rn tris conneaion, you are requested to submit the following information within .15 days of the issue of this lettlr. 1 Detaired manufacturino process, materiar barance with baranced chemicar reactions indicating arr the reactariis ana piooucis ;rJU-;;dr"ts with corresponding morecurar Formulae, structural formutae, moteiutar weighi "nJil;:, low diagram. -?,-s]:grryi:" percentage vierd with r".p"ii o] "rit-li tne reactants and products and the :?;ffili;'J|IT*:i"",icrosins therewith authentic pirnteJ tecr"rnicai tit",.tr,." il iripo-rt or yiero :3;i1';""1 bvproducts foimed during the process and recovery of sorvents in terms of quantitv 4 Details of production of export product under reference and corresponding consumption of raw materiar in the vear 2013-14 a.nd 2014-1s durv ;;;;fied ov cn ina,, oE trir'eili. rr tn" 3:"rtfii!"il5X:,,?":"ffi:X"il"BXl" the past, tt'" J"tiir'i,"i commencement or production may 5 Any other relevant information yours faithfully, xlds(*{ ,-Pffitr,,- (4.K. AGARWAL) Addl. lndustrial Adviser Tet. No. 0.11- 2338i430 copv to: shri Mahender Vikram singh, FTD., (DES-3) in reference to DGFT/U.No.- O 1 tB2tOsOt2OSt AM_1 6/DES_| il/ 230, dated 30.06.201 5.

F. No.3501 1/6241201 4-Pl (Norms) Government of lndia Ministry of Chemical & Fertilizers Department of Pharmaceuticals Shastri Bhawan, New Delhi. Dated: April 07,2015 Office Memorandum

subject: - Fixation of norms under para 4.7 of Hand Book of procedures (Vol.l) 2009-

'14 Case of M/s Caplin Point Labs Ltd. The undersigned is directed to refer to DGFT U.O. No. 011821501001079/AM15/DES-3/929 dated the 01.1.2015 vide which an apptication from M/s. caplin Point Labs Ltd was sent to this Department for fixation of norms under para: 4.7 lor lhe export of Heparin Sodium lnjection 5000 lU/ml in 5 ml vials. This department has examined the matter and it is requested that DGFT may call following document from the applicant:- certificate of Analysis (coA) of Heparin sodium to be imported alongwith the method of arriving at the quantity of Heparin sodium in mg applied against export of Heparin Sodium rnjection 5000 lU/ml in 5 ml vials. 2. This issues with the approval of Director (pharma lndustry). (Barnail Khastgir) Under Secretary to the Government of lndia phone: 23385765 Directorate General of Forergn Trade, Department of Commerce, (Shri MVSingh,FTDO), Udyog Bhawan, New Delhi.

Ir. No.3 50 1 I 124212015-PI (Norms) (iovernment of India Ministrl, ol' Cherrricals & Fertilizers Departrlent o1' Pharmaceuticals Udyog Bhiiwarr.New Delhi. Dated the Septenrber. 2015 Ofllce Memorandurn-r Sr"rb.iect: - Ii-ixation olnorrns under partr4.7 of Hand Book o['Procedures (Vol.l) 2009-14 C]ase of M/s Satyacleva Pharma Pvt t,td. 'l'lre undersigned is directed to relcr Lo DCF-f U.O.No. 01l82l50l164lAM-16/l)115-3/l l2 dated the 16106115 vide w'hich application from M/s. Satyadeva Pharrna Pvt Ltcl vras se-r.rt to this l)eparltrrent for frxation of norn.rs under para: 4.7 fbr the export ol' N-((N-Methyl-N-((2- Isopropvl-4-Thiazolyl) Methyl)Amino) Carbonyl) L-Valine, Lithium Salt (MTV-nt) 't'his departtrlent has examinecl the nratter ancl the following nonls arc firltisftec1 ulc]cr 1tara,1.7 91' Iland Book of Procedures (Vol.l) 2009-14:- (Barnali Khastgir) Under Secretary to the Governntent of India Phone:23071 I 62 Directorate General of Iroreign T'racle. Departntent of Contmerce. (Shri M.V. Singh. FTDO). Udyog llhawan. New Delhi S. No. Inrport Itcnt Qty. Rccornnre'nclccl k g/kg. | sobutramide 0666 つ 一 Tetrahydrolirran 1.486 う 、 ツ Methylene Chloricle l.272 4 Lithium Hydroxide Monohydrate 0.tt5 5. sopropyl Alcohol 0.49 6. \4eth1,l Tertian, []Lrty'l [ither 1.131 7. foluene 1.t4 8. Valine 0.60

IЧ Ъ Government of lndia Ministry of Chemicals and Fertilizers Department of Chemicals and Petrochemicals Subject: Advance AuthonzalOn applica籠on from M′s SAIBABA SURFACTANTS(P) litttllilililllliilil:|:ll!:]i]:||li::::HYLENE GLYCO Ll Ref: U.O. No. 01183150/12751AM1s/DESllU1075 dated 13.1.2015 M/s SAIBABA SURFACTANTS (P). Ltd. have submitted present application for the import of raw material against the export of POLY ETHYLENE GLYCOL The application have been examined and the Department recommends the following norms for the present Advance Authorization application. This issues with the approval of competent authority. lA K AGARWAL) Addl !ndustrial Adviser Tel No 011‐23381430 shn Mahender∨lkram Sinqh,FTDO(DES―lll1 0/o DGFT.Udvoo Bhawan.New Delhi-11 Deptt.of C&PC U O No 14010/56/2013-CHJl date"。112015 1 . ltem of Export Qty Item of lmport Qty POLY ETHYLENE GLYCOL‐4000 l kg l ETHYLENE OXIDE 0 735 Kg 2.DlETHYLENE GLYCOL 0 265Kg. 2 にem of ExpOrt Qty Item of lmport Qty POLY I ETHYLENE GLYCOL‐6000 l kg l ETHYLENE OXIDE _____珈 0 982 Kg. 2 DIETHYLENE GLYCOL 0 018Kq 3. ltem of Export Qtv Item of lmport Qty POLY ETHYLENE CLYCOL‐8000 l kg l ETHYLENE OXIDE 0 986Kg 2 DIETHYLENE GLYCOL 0 014Kg. 4. ltem of Export Qtv Item of lmport Qty CASTOR OIL ETHOXYLATE l kg l ETHYLENE OXIDE 0.660 Kg 2 CASTOR OIL 0.340 Kg 5 1tem of Export Qty Item of lmport Qty FAπY ALCOHOL ETHOXYLATE 25 l kg l FAttY ALCOHOL 0 180 KO. 2 ETHYLENE OXIDE 0 820Kg 葉尋り ・ 、t めン致rl憲《nf

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