DGFT Committee Minutes

1 Government of India Ministry of Commerce and Industry Directorate General of Foreign Trade Maulana Azad Road, New Delhi 110011 Norms Committee-III

Para 4.7 Decision

Meeting No. 19/82/2016 of 2016-17 dated 08.03.2017 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, held on 08.03.2017 under the Chairmanship of Shri J.V. Patil, Addl. DGFT in Room No.04, Udyog Bhawan, New Delhi. Following members were present:- Shri Nirmal Kumar, Dy. Director General of Foreign Trade Shri V.K. Tyagi, Consultant, D/o Pharmaceuticals. The committee went through the minutes of earlier meeting No. 18/82 dated 15.02.2017 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 Committee does not approve SCOMET items and all applicants are understood to have furnished a declaration to RA tht the items of import/export are not SCOMET items. MEETING NUMBER : 19/82-ALC4/2016 MEETING DATE : 08.03.2017 1

Case No.:60/17/82-ALC4/2016 Party Name:MYLAN

LABORATORIES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01021/AM17/ RLA File :09/24/040/00021/AM14/ Lic.No/Date:0910055945 07.05.2013 Defer Date: 12.04.2017 Decision :Deferred for want of comments from DoP. 2

Case No.:5/17/82-ALC4/2016

Party Name:SNF [INDIA] PVT. LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00966/AM17/ RLA File :26/24/040/00012/AM14/ Lic.No/Date:2610012456 27.02.2014 Defer Date: 12.04.2017 Decision :Deferred. 3

Case No.:61/4/82-ALC4/2014

Party Name:V & V PHARMA INDUSTRIES Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred

2 HQ File :01/82/050/00309/AM15/ RLA File :03/95/040/00190/AM15/ Lic.No/Date:0310785305 13.06.2014 Defer Date: 12.04.2017 Decision :Deferred. 4

Case No.:73/9/82-ALC4/2014

Party Name:D. R. COATS INK & RESINS PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00870/AM15/ RLA File :03/94/040/00755/AM14/ Lic.No/Date:0310786181 30.06.2014 Defer Date: 12.04.2017 Decision :Deferred. 5

Case No.:396/5/82-ALC4/2015 Party Name:ESTEEM

INDUSTRIES PVT. LTD, Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00536/AM16/ RLA File :17/24/040/00047/AM15/ Lic.No/Date:1710005887 24.07.2014 Defer Date: 12.04.2017 Decision :Deferred. 6

Case No.:32/9/82-ALC4/2014

Party Name:CHEMCON SPECIALITY CHEMICALS P LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00829/AM15/ RLA File :34/24/040/00102/AM15/ Lic.No/Date:3410040406 28.07.2014 Defer Date: 12.04.2017 Decision :Deferred. 7

Case No.:8/6/82-ALC4/2014

Party Name:V & V PHARMA INDUSTRIES Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00410/AM15/ RLA File :03/95/040/00331/AM15/ Lic.No/Date:0310787382 28.07.2014 Defer Date: 12.04.2017 Decision :Deferred. 8

Case No.:31/9/82-ALC4/2014

Party Name:AMBERNATH ORGANICS PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00828/AM15/ RLA File :03/94/040/00074/AM15/ Lic.No/Date:0310787610 04.08.2014 Defer Date: 12.04.2017 Decision :Deferred. 9

Case No.:44/13/82-ALC4/2014 Party Name:SRIAM LABS

PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01047/AM15/ RLA File :09/24/040/00237/AM15/ Lic.No/Date:0910060843 12.08.2014 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.07/82 dated 24.07.2015, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per decision of NC.

3 10

Case No.:224/13/82-

ALC4/2014 Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01227/AM15/ RLA File :03/94/040/00391/AM15/ Lic.No/Date:0310788515 28.08.2014 Defer Date: 12.04.2017 Decision :Deferred. 11

Case No.:225/13/82-

ALC4/2014 Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01228/AM15/ RLA File :03/94/040/00397/AM15/ Lic.No/Date:0310788514 28.08.2014 Defer Date: 12.04.2017 Decision :Deferred. 12

Case No.:223/13/82-

ALC4/2014 Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01226/AM15/ RLA File :03/94/040/00508/AM15/ Lic.No/Date:0310788647 02.09.2014 Defer Date: 12.04.2017 Decision :Deferred. 13

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

& CHEMICALS Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00540/AM16/ RLA File :34/24/040/00120/AM15/ Lic.No/Date:3410040554 15.09.2014 Defer Date: 12.04.2017 Decision :Deferred. 14

Case No.:29/13/82-ALC4/2014 Party Name:JUBILANT LIFE

SCIENCES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01032/AM15/ RLA File :05/23/040/00268/AM15/ Lic.No/Date:0510391490 08.10.2014 Defer Date: 12.04.2017 Decision :Deferred. 15

Case No.:124/13/82-

ALC4/2014 Party Name:PANACEA BIOTEC LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01127/AM15/ RLA File :05/24/040/00319/AM15/ Lic.No/Date:0510391623 17.10.2014 Defer Date: 12.04.2017 Decision : Deferred for want of comments from DBT. 16

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

PHARMACEUTICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00338/AM16/ RLA File :04/24/040/00205/AM15/ Lic.No/Date:0410159704 11.11.2014 Defer Date: 12.04.2017

4 Decision : Deferred for want of comments from DoP. 17

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

CROPSCIENCE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00922/AM16/ RLA File :03/94/040/00710/AM15/ Lic.No/Date:0310791177 18.11.2014 Defer Date: 12.04.2017 Decision :Deferred. 18

Case No.:385/5/82-ALC4/2015 Party Name:AMI ORGANICS

PVT LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00525/AM16/ RLA File :52/24/040/00044/AM15/ Lic.No/Date:5210041339 05.12.2014 Defer Date: Decision : Decision: The Committee considered this case for fixation of norms as per agenda. The Committee based on the earlier recommendation of Department of C&PC forwarded vide U.O.No.14010/2/2014-Ch-II dated 21.10.2015, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per decision of NC. 19

Case No.:221/5/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00361/AM16/ RLA File :09/24/040/00537/AM15/ Lic.No/Date:0910061442 23.12.2014 Defer Date: 12.04.2017 Decision :Deferred. 20

Case No.:114/5/82-ALC4/2015 Party Name:NATIONAL TUBE

INDUSTRIES, Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00254/AM16/ RLA File :03/95/040/00756/AM15/ Lic.No/Date:0310792363 24.12.2014 Defer Date: 12.04.2017 Decision :Deferred. 21

Case No.:218/5/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00358/AM16/ RLA File :09/24/040/00552/AM15/ Lic.No/Date:0910061462 29.12.2014 Defer Date: 12.04.2017 Decision :Deferred. 22

Case No.:45/5/82-ALC4/2015

Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00185/AM16/ RLA File :09/24/040/00558/AM15/ Lic.No/Date:0910061483 05.01.2015 Defer Date: 12.04.2017

5 Decision : The Committee decided to call for information from the firm based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.no.35011/1/2016-PI(Norms) dated 1.06.2016 , uploaded at the end of these minutes and deferred the case. 23

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

LABORATORIES Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00289/AM16/ RLA File :03/94/040/00813/AM15/ Lic.No/Date:0310792673 08.01.2015 Defer Date: 12.04.2017 24

Case No.:219/5/82-ALC4/2015 Party Name:BHAGIRADHA

CHEMICALS & INDUSTRIES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00359/AM16/ RLA File :09/24/040/00549/AM15/ Lic.No/Date:0910061517 09.01.2015 Defer Date: 12.04.2017 Decision :Deferred. 25

Case No.:112/5/82-ALC4/2015 Party Name:UNIMAX

CHEMICALS PVT LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00252/AM16/ RLA File :03/95/040/00812/AM15/ Lic.No/Date:0310793039 19.01.2015 Defer Date: 12.04.2017 26

Case No.:88/5/82-ALC4/2015

Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00228/AM16/ RLA File :05/23/040/00486/AM15/ Lic.No/Date:0510392949 21.01.2015 Defer Date: 12.04.2017 Decision :Deferred for want of comments from DBT. 27

Case No.:138/8/82-ALC4/2015 Party Name:HEMMO

PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00934/AM16/ RLA File :03/94/040/01099/AM14/ Lic.No/Date:0310793426 30.01.2015 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.18/82 dated 02.08.2011, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 28

Case No.:275/5/82-ALC4/2015 Party Name:BAYER

CROPSCIENCE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00415/AM16/ RLA File :03/94/040/00930/AM15/ Lic.No/Date:0310793539 03.02.2015 Defer Date: 12.04.2017 Decision :Deferred.

6 29

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

VALLABH CHEMICAL Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00449/AM16/ RLA File :08/24/040/00417/AM15/ Lic.No/Date:0810134670 25.02.2015 Defer Date: 12.04.2017 Decision :Deferred. 30

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

LABORATORIES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01022/AM17/ RLA File :09/24/040/00607/AM15/ Lic.No/Date:0910061652 26.02.2015 Defer Date: 12.04.2017 31

Case No.:273/5/82-ALC4/2015 Party Name:BHARAT

SERUMS & VACCINES LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00413/AM16/ RLA File :03/94/040/01055/AM15/ Lic.No/Date:0310794262 27.02.2015 Defer Date: 12.04.2017 32

Case No.:303/5/82-ALC4/2015 Party Name:ASSOCIATED

DYESTUFF PVT. LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00443/AM16/ RLA File :08/24/040/00422/AM15/ Lic.No/Date:0810134739 05.03.2015 Defer Date: 12.04.2017 Decision :Deferred. 33

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

PETROCHEMICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00440/AM16/ RLA File :08/24/040/00448/AM15/ Lic.No/Date:0810134768 11.03.2015 Defer Date: 12.04.2017 Decision :Deferred. 34

Case No.:447/5/82-ALC4/2015 Party Name:AARTI

INDUSTRIES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00587/AM16/ RLA File :03/94/040/01131/AM15/ Lic.No/Date:0310794543 12.03.2015 Defer Date: 12.04.2017 35

Case No.:29/5/82-ALC4/2015

Party Name:ASSOCIATED DYESTUFF PVT. LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00169/AM16/ RLA File :08/24/040/00483/AM15/ Lic.No/Date:0810134917 25.03.2015 Defer Date: 12.04.2017

7 Decision :Deferred. 36

Case No.:26/5/82-ALC4/2015

Party Name:CONTINENTAL CHEMICALS Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00166/AM16/ RLA File :08/24/040/00470/AM15/ Lic.No/Date:0810134992 07.04.2015 Defer Date: 12.04.2017 Decision :Deferred. 37

Case No.:132/7/82-ALC4/2015 Party Name:GLOBE

TROTTERS PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00737/AM16/ RLA File :03/94/040/00024/AM16/ Lic.No/Date:0310795429 20.04.2015 Defer Date: 12.04.2017 Decision : Information called for from the firm in NC meeting No.07/82 dated 07.07.2016 is awaited. The Committee accordingly deferred the case. 38

Case No.:40/8/82-ALC4/2015

Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00836/AM16/ RLA File :09/24/040/00042/AM16/ Lic.No/Date:0910061937 27.04.2015 Defer Date: 12.04.2017 Decision :Deferred. 39

Case No.:75/8/82-ALC4/2015

Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00871/AM16/ RLA File :09/24/040/00051/AM16/ Lic.No/Date:0910061986 06.05.2015 Defer Date: 12.04.2017 Decision :Deferred. 40

Case No.:97/8/82-ALC4/2015

Party Name:ASCENT FINECHEM PVT. LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00893/AM16/ RLA File :08/24/040/00051/AM16/ Lic.No/Date:0810135338 22.05.2015 Defer Date: 12.04.2017 Decision :Deferred. 41

Case No.:86/8/82-ALC4/2015

Party Name:VIVIMED LABS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00882/AM16/ RLA File :09/24/040/00131/AM16/ Lic.No/Date:0910062091 29.05.2015 Defer Date: 12.04.2017 Decision :Deferred. 42 Case No.:187/7/82-ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:19/82- ALC4/2016 Status: Deferred

8 08.03.2017 HQ File :01/82/050/00792/AM16/ RLA File :08/24/040/00057/AM16/ Lic.No/Date:0810135435 05.06.2015 Defer Date: 12.04.2017 Decision :Deferred. 43

Case No.:24/13/82-ALC4/2016 Party Name:ARENE LIFE

SCIENCES LIMITED. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00652/AM17/ RLA File :09/24/040/00034/AM16/ Lic.No/Date:0910062155 10.06.2015 Defer Date: 12.04.2017 44

Case No.:89/7/82-ALC4/2015

Party Name:HALDIA PETROCHEMICALS LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00694/AM16/ RLA File :02/24/040/00045/AM16/ Lic.No/Date:0210205925 26.06.2015 Defer Date: 12.04.2017 Decision :Deferred. 45

Case No.:97/14/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01233/AM16/ RLA File :09/24/040/00186/AM16/ Lic.No/Date:0910062271 01.07.2015 Defer Date: 12.04.2017 Decision :Deferred. 46

Case No.:108/17/82-

ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01069/AM17/ RLA File :07/24/040/00112/AM16/ Lic.No/Date:0710108483 08.07.2015 Defer Date: 12.04.2017 Decision :Deferred. 47

Case No.:50/8/82-ALC4/2015

Party Name:PUSILIN BIOTECHNOLOGY PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00846/AM16/ RLA File :06/24/040/00014/AM16/ Lic.No/Date:0610038189 09.07.2015 Defer Date: 12.04.2017 48

Case No.:54/14/82-ALC4/2015 Party Name:BIOLOGICAL E

LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01190/AM16/ RLA File :09/24/040/00524/AM15/ Lic.No/Date:0910062332 15.07.2015 Defer Date: 12.04.2017

9 49

Case No.:59/14/82-ALC4/2015 Party Name:BIOLOGICAL E

LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01195/AM16/ RLA File :09/24/040/00525/AM15/ Lic.No/Date:0910062331 15.07.2015 Defer Date: 12.04.2017 50

Case No.:49/8/82-ALC4/2015

Party Name:M.L.A. INDUSTRIES Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00845/AM16/ RLA File :06/24/040/00015/AM16/ Lic.No/Date:0610038193 16.07.2015 Defer Date: 12.04.2017 Decision :Deferred. 51

Case No.:49/14/82-ALC4/2015 Party Name:SYNTHO

CHIRALS PVT. LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01185/AM16/ RLA File :09/24/040/00205/AM16/ Lic.No/Date:0910062344 17.07.2015 Defer Date: 12.04.2017 Decision :Deferred. 52

Case No.:1/10/82-ALC4/2015

Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00957/AM16/ RLA File :09/24/040/00211/AM16/ Lic.No/Date:0910062393 28.07.2015 Defer Date: 12.04.2017 Decision :Deferred. 53

Case No.:131/14/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01267/AM16/ RLA File :09/24/040/00212/AM16/ Lic.No/Date:0910062413 30.07.2015 Defer Date: 12.04.2017 Decision :Deferred. 54

Case No.:60/14/82-ALC4/2015 Party Name:PORUS

LABORATORIES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01196/AM16/ RLA File :09/24/040/00256/AM16/ Lic.No/Date:0910062418 31.07.2015 Defer Date: 12.04.2017 Decision :Deferred. 55

Case No.:84/1/82-ALC1/2016

Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01858/AM16/ RLA File :08/91/040/00210/AM16/ Lic.No/Date:0810135770 03.08.2015 Defer Date: Decision : The Committee based on the suggestions of representative of D/o

10 Pharmaceuticals in the meeting decided to ratify norms as per SION A-205 or as applied by the firm whichever is less under Para 4.07 of HBP. RA concerned may take further necessary action as per decision of NC. 56

Case No.:169/14/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01305/AM16/ RLA File :31/83/040/00018/AM16/ Lic.No/Date:3110065573 03.08.2015 Defer Date: 12.04.2017 Decision :Deferred. 57

Case No.:17/8/82-ALC4/2015

Party Name:VIVIMED LABS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00813/AM16/ RLA File :09/24/040/00251/AM16/ Lic.No/Date:0910062426 03.08.2015 Defer Date: 12.04.2017 Decision :Deferred. 58

Case No.:168/14/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01304/AM16/ RLA File :31/83/040/00024/AM16/ Lic.No/Date:3110065579 04.08.2015 Defer Date: 12.04.2017 Decision :Deferred. 59

Case No.:18/14/82-ALC4/2015 Party Name:METROPOLITAN

EXIMCHEM PRIVATE LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01154/AM16/ RLA File :03/95/040/00317/AM16/ Lic.No/Date:0310798039 10.08.2015 Defer Date: 12.04.2017 Decision :Deferred. 60

Case No.:155/14/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01291/AM16/ RLA File :05/24/040/00237/AM16/ Lic.No/Date:0510395271 11.08.2015 Defer Date: 12.04.2017 Decision : Information was called from the firm in NC meeting No.17 dated 24.1.2017 is awaited. The Committee accordingly deferred the case. 61

Case No.:11/18/82-ALC4/2015 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01476/AM16/ RLA File :03/95/040/00327/AM16/ Lic.No/Date:0310798117 13.08.2015 Defer Date: 12.04.2017 Decision :Deferred.

11 62

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

INDUSTRY LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01170/AM16/ RLA File :34/24/040/00144/AM16/ Lic.No/Date:3410041464 17.08.2015 Defer Date: 12.04.2017 Decision :Deferred. 63

Case No.:56/13/82-ALC4/2015 Party Name:PANACEA

BIOTEC LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01019/AM16/ RLA File :05/24/040/00183/AM16/ Lic.No/Date:0510395354 18.08.2015 Defer Date: 12.04.2017 64

Case No.:154/14/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01290/AM16/ RLA File :05/24/040/00381/AM15/ Lic.No/Date:0510395357 19.08.2015 Defer Date: NC in its meeting No.15/82 dated 12.07.2011, uploaded at the end of these minutes or as 65

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

CHEMICALS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01204/AM16/ RLA File :09/24/040/00368/AM15/ Lic.No/Date:0910062518 19.08.2015 Defer Date: 12.04.2017 Decision :Deferred. 66

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

SPECIALTY PRODUCTS Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01160/AM16/ RLA File :03/95/040/00348/AM16/ Lic.No/Date:0310798516 27.08.2015 Defer Date: 12.04.2017 Decision :Deferred. 67

Case No.:82/14/82-ALC4/2015 Party Name:PAYAL

PETROCHEM PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01218/AM16/ RLA File :05/24/040/00233/AM16/ Lic.No/Date:0510395480 31.08.2015 Defer Date: NC in its meeting No.08/82 dated 16.09.2015, uploaded at the end of these minutes or as

12 68

Case No.:89/14/82-ALC4/2015 Party Name:PAYAL

PETROCHEM PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01225/AM16/ RLA File :05/24/040/00224/AM16/ Lic.No/Date:0510395479 31.08.2015 Defer Date: NC in its meeting No.08/82 dated 16.09.2015, uploaded at the end of these minutes or as 69

Case No.:94/14/82-ALC4/2015 Party Name:PAYAL

PETROCHEM PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01230/AM16/ RLA File :05/24/040/00202/AM16/ Lic.No/Date:0510395481 31.08.2015 Defer Date: NC in its meeting No.15/82 dated 12.07.2011, uploaded at the end of these minutes or as 70

Case No.:116/16/82-

ALC4/2015 Party Name:PANERA BIOTEC PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01436/AM16/ RLA File :05/24/040/00181/AM16/ Lic.No/Date:0510395496 01.09.2015 Defer Date: 12.04.2017 71

Case No.:93/14/82-ALC4/2015 Party Name:SUN

PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01229/AM16/ RLA File :05/24/040/00244/AM16/ Lic.No/Date:0510395493 01.09.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded earlier vide O.M.No.35011/141/2016PI(Norms) dated July 2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 72

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

INDUSTRIES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00298/AM17/ RLA File :03/94/040/00424/AM16/ Lic.No/Date:0310798671 04.09.2015 Defer Date: 12.04.2017 73

Case No.:56/14/82-ALC4/2015 Party Name:SALICYLATES &

CHEMICALS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File RLA File Lic.No/Date:0910062560 Defer Date:

13 :01/82/050/01192/AM16/ :09/24/040/00134/AM16/ 08.09.2015 NC in its meeting No.24/82 dated 15.11.2012, uploaded at the end of these minutes or as 74

Case No.:46/14/82-ALC4/2015 Party Name:MALWA

OXYGEN & INDUSTRIAL GASES PVT.LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01182/AM16/ RLA File :56/24/040/00005/AM16/ Lic.No/Date:5610004674 09.09.2015 Defer Date: 12.04.2017 Decision :Deferred. 75

Case No.:157/14/82-

ALC4/2015 Party Name:AETHER INDUSTRIES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01293/AM16/ RLA File :52/24/040/00042/AM16/ Lic.No/Date:5210041630 10.09.2015 Defer Date: 12.04.2017 Decision :Deferred. 76

Case No.:8/14/82-ALC4/2015

Party Name:PRIVI ORGANICS LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01144/AM16/ RLA File :03/95/040/00343/AM16/ Lic.No/Date:0310798846 14.09.2015 Defer Date: NC in its meeting No.21/82 dated 23.08.2011, uploaded at the end of these minutes or as 77

Case No.:110/14/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01246/AM16/ RLA File :09/24/040/00305/AM16/ Lic.No/Date:0910062601 14.09.2015 Defer Date: NC in its meeting No.24/82 dated 15.11.2012, uploaded at the end of these minutes or as 78

Case No.:134/14/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01270/AM16/ RLA File :09/24/040/00273/AM16/ Lic.No/Date:0910062602 14.09.2015 Defer Date: NC in its meeting No.26/82 dated 13.12.2012, uploaded at the end of these minutes or as

14 79

Case No.:74/14/82-ALC4/2015 Party Name:BEST VALUE

CHEM PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01210/AM16/ RLA File :34/24/040/00120/AM16/ Lic.No/Date:3410041510 15.09.2015 Defer Date: NC in its meeting No.47/82 dated 21.02.2012, uploaded at the end of these minutes or as 80

Case No.:9/14/82-ALC4/2015

Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01145/AM16/ RLA File :03/95/040/00434/AM16/ Lic.No/Date:0310798944 16.09.2015 Defer Date: 12.04.2017 Decision :Deferred. 81

Case No.:124/14/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01260/AM16/ RLA File :09/24/040/00355/AM16/ Lic.No/Date:0910062622 16.09.2015 Defer Date: NC in its meeting No.04/AM13 dated 16.05.2013, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per decision of NC. 82

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

& RESINS PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01355/AM16/ RLA File :03/94/040/00415/AM16/ Lic.No/Date:0310798977 21.09.2015 Defer Date: 12.04.2017 Decision :Deferred. 83

Case No.:64/21/82-ALC4/2015 Party Name:CADILA

HEALTHCARE LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01769/AM16/ RLA File :08/24/040/00137/AM16/ Lic.No/Date:0810136085 22.09.2015 Defer Date: 12.04.2017 84

Case No.:117/14/82-

ALC4/2015 Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01253/AM16/ RLA File :04/24/040/00140/AM16/ Lic.No/Date:0410161044 22.09.2015 Defer Date: 12.04.2017 Decision : Information received from the firm and sent to DoP for comments. The

15 Committee accordingly deferred the case. 85

Case No.:106/14/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01242/AM16/ RLA File :09/24/040/00373/AM16/ Lic.No/Date:0910062649 23.09.2015 Defer Date: 12.04.2017 86

Case No.:91/14/82-ALC4/2015 Party Name:CURETECH

SKINCARE Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01227/AM16/ RLA File :22/21/040/00029/AM16/ Lic.No/Date:2210015316 24.09.2015 Defer Date: 12.04.2017 87

Case No.:86/14/82-ALC4/2015 Party Name:BELLAPREMIER

HAPPY HYGIENECARE PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01222/AM16/ RLA File :35/24/040/00005/AM16/ Lic.No/Date:3510044794 25.09.2015 Defer Date: 12.04.2017 88

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

PHARMACEUTICALS PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01215/AM16/ RLA File :05/23/040/00274/AM16/ Lic.No/Date:0510395773 30.09.2015 Defer Date: 12.04.2017 89

Case No.:69/16/82-ALC4/2015 Party Name:PIDILITE

INDUSTRIES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01389/AM16/ RLA File :03/95/040/00350/AM15/ Lic.No/Date:0310799113 30.09.2015 Defer Date: 12.04.2017 Decision :Deferred. 90

Case No.:43/16/82-ALC4/2015 Party Name:INDOFIL

INDUSTRIES LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01363/AM16/ RLA File :03/94/040/00423/AM16/ Lic.No/Date:0310799184 05.10.2015 Defer Date: NC in its meeting No.25/82 dated 29.11.2012, uploaded at the end of these minutes or as

16 91

Case No.:139/14/82-

ALC4/2015 Party Name:MAMTA POLYCOATS Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01275/AM16/ RLA File :34/24/040/00178/AM16/ Lic.No/Date:3410041581 08.10.2015 Defer Date: 12.04.2017 Decision :Deferred. 92

Case No.:62/16/82-ALC4/2015 Party Name:SURVIVAL

TECHNOLOGIES PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01382/AM16/ RLA File :03/95/040/00491/AM16/ Lic.No/Date:0310799292 08.10.2015 Defer Date: 12.04.2017 Decision :Deferred. 93

Case No.:164/14/82-

ALC4/2015 Party Name:AASHA BIOCHEM Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01300/AM16/ RLA File :10/24/040/00049/AM16/ Lic.No/Date:1010059293 12.10.2015 Defer Date: 12.04.2017 94

Case No.:140/14/82-

ALC4/2015 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01276/AM16/ RLA File :34/24/040/00175/AM16/ Lic.No/Date:3410041586 12.10.2015 Defer Date: NC in its meeting No.03/82 dated 02.05.2013, uploaded at the end of these minutes or as 95

Case No.:132/14/82-

ALC4/2015 Party Name:RIDDHI PHARMA Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01268/AM16/ RLA File :34/24/040/00180/AM16/ Lic.No/Date:3410041592 14.10.2015 Defer Date: NC in its meeting No.49/82 dated 06.03.2012, uploaded at the end of these minutes or as 96

Case No.:116/13/82-

ALC4/2016 Party Name:SOFTGEL HEALTH CARE PVT. LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00744/AM17/ RLA File :04/24/040/00143/AM16/ Lic.No/Date:0410161132 20.10.2015 Defer Date: 12.04.2017

17 97

Case No.:72/16/82-ALC4/2015 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01392/AM16/ RLA File :03/95/040/00102/AM16/ Lic.No/Date:0310799579 21.10.2015 Defer Date: 12.04.2017 Decision :Deferred. 98

Case No.:73/16/82-ALC4/2015 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01393/AM16/ RLA File :03/95/040/00087/AM16/ Lic.No/Date:0310799578 21.10.2015 Defer Date: 12.04.2017 Decision :Deferred. 99

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

CHEMICALS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01349/AM16/ RLA File :09/24/040/00379/AM16/ Lic.No/Date:0910062768 23.10.2015 Defer Date: 12.04.2017 Decision :Deferred. 100

Case No.:30/16/82-ALC4/2015 Party Name:SALICYLATES &

CHEMICALS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01350/AM16/ RLA File :09/24/040/00383/AM16/ Lic.No/Date:0910062767 23.10.2015 Defer Date: NC in its meeting No.11/82 dated 26.11.2014, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary 101

Case No.:129/16/82-

ALC4/2015 Party Name:SURVIVAL Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01449/AM16/ RLA File :03/95/040/00505/AM16/ Lic.No/Date:0310799628 23.10.2015 Defer Date: 12.04.2017 Decision :Deferred. 102

Case No.:161/14/82-

ALC4/2015 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01297/AM16/ RLA File :03/94/040/01226/AM15/ Lic.No/Date:0310799680 26.10.2015 Defer Date: 12.04.2017 Decision :Deferred. 103

Case No.:78/16/82-ALC4/2015 Party Name:MOHINI

ORGANICS PVT. LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved

18 HQ File :01/82/050/01398/AM16/ RLA File :03/95/040/00777/AM15/ Lic.No/Date:0310799666 26.10.2015 Defer Date: NC in its meeting No.49/82 dated 06.03.2012, uploaded at the end of these minutes or 104

Case No.:31/16/82-ALC4/2015 Party Name:MSN

LABORATORIES PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01351/AM16/ RLA File :09/24/040/00423/AM16/ Lic.No/Date:0910062790 28.10.2015 Defer Date: 12.04.2017 Decision : The Committee noted that information has been called for from the firm in NC meeting No.05/82 dated 08.06.2016 is awaited. The Committee decided to await the reply and deferred the case. 105

Case No.:74/16/82-ALC4/2015 Party Name:PERFECT

VITAMINS PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01394/AM16/ RLA File :03/95/040/00518/AM16/ Lic.No/Date:0310799705 28.10.2015 Defer Date: 12.04.2017 Decision :Deferred. 106

Case No.:75/16/82-ALC4/2015 Party Name:SURVIVAL

Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01395/AM16/ RLA File :03/95/040/00525/AM16/ Lic.No/Date:0310799704 28.10.2015 Defer Date: 12.04.2017 Decision :Deferred. 107

Case No.:47/16/82-ALC4/2015 Party Name:SURVIVAL

Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01367/AM16/ RLA File :03/95/040/00526/AM16/ Lic.No/Date:0310799853 29.10.2015 Defer Date: 12.04.2017 Decision :Deferred. 108

Case No.:48/16/82-ALC4/2015 Party Name:O C

SPECIALITIES PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01368/AM16/ RLA File :03/95/040/00549/AM16/ Lic.No/Date:0310799873 30.10.2015 Defer Date: 12.04.2017 Decision :Deferred. 109

Case No.:159/14/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File RLA File Lic.No/Date:0510396075 Defer Date:

19 :01/82/050/01295/AM16/ :05/24/040/00343/AM16/ 30.10.2015 12.04.2017 Decision : The Committee noted that information has been called for from the firm in NC meeting No.17/82 dated 24.01.2017 is awaited. The Committee decided to await the reply and deferred the case. 110

Case No.:118/16/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01438/AM16/ RLA File :05/24/040/00345/AM16/ Lic.No/Date:0510396076 30.10.2015 Defer Date: 12.04.2017 Decision : The Committee noted that information has been called for from the firm in NC meeting No.17/82 dated 24.01.2017 is awaited. The Committee decided to await the reply and deferred the case. 111

Case No.:107/16/82-

ALC4/2015 Party Name:HELLO PAINTS (P) LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01427/AM16/ RLA File :05/23/040/00326/AM16/ Lic.No/Date:0510396204 03.11.2015 Defer Date: NC in its meeting No.14/82 dated 24.10.2013, uploaded at the end of these minutes or 112

Case No.:88/16/82-ALC4/2015 Party Name:SHIVA

PHARMACHEM LTD, Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01408/AM16/ RLA File :34/24/040/00202/AM16/ Lic.No/Date:3410041663 05.11.2015 Defer Date: NC in its meeting No.07/82 dated 27.06.2013, uploaded at the end of these minutes or 113

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

ORGANIC INDUSTRIES LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01373/AM16/ RLA File :03/95/040/00540/AM16/ Lic.No/Date:0310800090 06.11.2015 Defer Date: 12.04.2017 Decision :Deferred. 114

Case No.:89/16/82-ALC4/2015 Party Name:GULBRANDSEN

CHEMICALS PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01409/AM16/ RLA File :34/24/040/00203/AM16/ Lic.No/Date:3410041666 09.11.2015 Defer Date: 12.04.2017 Decision :Deferred.

20 115

Case No.:114/17/82-

ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01075/AM17/ RLA File :07/24/040/00255/AM16/ Lic.No/Date:0710109043 13.11.2015 Defer Date: NC in its meeting No.03/82 dated 08.05.2014, uploaded at the end of these minutes or 116

Case No.:114/16/82-

ALC4/2015 Party Name:SHIVA BIOCHEM INDUSTRIES Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01434/AM16/ RLA File :50/24/040/00017/AM16/ Lic.No/Date:5010002240 16.11.2015 Defer Date: 12.04.2017 Decision :Deferred. 117

Case No.:4/20/82-ALC4/2015

Party Name:AIMS IMPEX PVT. LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01587/AM16/ RLA File :03/94/040/00656/AM16/ Lic.No/Date:0310800363 23.11.2015 Defer Date: 12.04.2017 Decision :Deferred. 118

Case No.:31/1/82-ALC1/2016

Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01805/AM16/ RLA File :05/24/040/00347/AM16/ Lic.No/Date:0510396399 23.11.2015 Defer Date: 12.04.2017 Decision :Deferred. 119

Case No.:2/20/82-ALC4/2015

Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01585/AM16/ RLA File :05/24/040/00400/AM16/ Lic.No/Date:0510396400 23.11.2015 Defer Date: NC in its meeting No.23/82 dated 01.11.2012, uploaded at the end of these minutes or 120

Case No.:33/1/82-ALC1/2016

Party Name:INCHEM LABORATORIES PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01807/AM16/ RLA File :09/24/040/00486/AM16/ Lic.No/Date:0910062902 26.11.2015 Defer Date: NC in its meeting No.48/82 dated 28.02.2012 as per detail given below or as applied by the firm whichever is less.

21 Export product Qty. Import item Qty. Amisulpride 1kg. 4-Amino-5-(Ethylsulfonyl)-2- Methoxybenzoic Acid 0.892kg [(2RS(-1-Ethylpyrrolidine-2-YL]- Methanamine 0.528kg RA concerned may take further necessary action as per decision of NC. 121

Case No.:32/16/82-ALC4/2015 Party Name:INTERMED,

Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01352/AM16/ RLA File :04/24/040/00177/AM16/ Lic.No/Date:0410161343 26.11.2015 Defer Date: 12.04.2017 122

Case No.:2/1/82-ALC1/2016

Party Name:UNIJULES LIFE SCIENCES LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01776/AM16/ RLA File :03/95/040/00632/AM16/ Lic.No/Date:0310800416 26.11.2015 Defer Date: 12.04.2017 123

Case No.:58/20/82-ALC4/2015 Party Name:NEOGEN

CHEMICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01641/AM16/ RLA File :03/95/040/00182/AM15/ Lic.No/Date:0310800550 01.12.2015 Defer Date: 12.04.2017 Decision :Deferred. 124

Case No.:3/1/82-ALC1/2016

Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01777/AM16/ RLA File :03/95/040/00529/AM15/ Lic.No/Date:0310800547 01.12.2015 Defer Date: 12.04.2017 Decision : Deferred. 125

Case No.:5/1/82-ALC1/2016

Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01779/AM16/ RLA File :03/95/040/00239/AM15/ Lic.No/Date:0310800551 01.12.2015 Defer Date: 12.04.2017 126

Case No.:54/20/82-ALC4/2015 Party Name:MELOG

SPECIALITY CHEMICALS PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File RLA File Lic.No/Date:0310800619 Defer Date:

22 :01/82/050/01637/AM16/ :03/95/040/00631/AM16/ 03.12.2015 NC in its meeting No.06/82 dated 13.06.2013, uploaded at the end of these minutes or 127

Case No.:112/20/82-

ALC4/2015 Party Name:SUPREET CHEMICALS PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01695/AM16/ RLA File :03/95/040/00646/AM16/ Lic.No/Date:0310800620 03.12.2015 Defer Date: 12.04.2017 128

Case No.:127/16/82-

ALC4/2015 Party Name:BLUELINE FOODS (INDIA) PVT.LTD, Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01447/AM16/ RLA File :07/24/040/00267/AM16/ Lic.No/Date:0710109146 08.12.2015 Defer Date: 12.04.2017 129

Case No.:36/20/82-ALC4/2015 Party Name:BAYER VAPI

PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01619/AM16/ RLA File :03/94/040/00651/AM16/ Lic.No/Date:0310800833 09.12.2015 Defer Date: 12.04.2017 130

Case No.:110/20/82-

ALC4/2015 Party Name:PROCESS AGROCHEM INDUSTRIES PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01693/AM16/ RLA File :56/24/040/00040/AM16/ Lic.No/Date:5610004767 10.12.2015 Defer Date: 12.04.2017 131

Case No.:66/20/82-ALC4/2015 Party Name:PRIVI ORGANICS

LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01649/AM16/ RLA File :03/95/040/00633/AM16/ Lic.No/Date:0310800935 11.12.2015 Defer Date: NC in its meeting No.21/82 dated 23.08.2011, uploaded at the end of these minutes or 132

Case No.:45/20/82-ALC4/2015 Party Name:KRISHNA

ANTIOXIDANTS PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File RLA File Lic.No/Date:0310800992 Defer Date:

23 :01/82/050/01628/AM16/ :03/94/040/00736/AM16/ 14.12.2015 12.04.2017 133

Case No.:24/20/82-ALC4/2015 Party Name:NAVIN

FLUORINE INTERNATIONAL LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01607/AM16/ RLA File :03/95/040/00088/AM16/ Lic.No/Date:0310800991 14.12.2015 Defer Date: 12.04.2017 134

Case No.:46/20/82-ALC4/2015 Party Name:JINDAL DRUGS

PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01629/AM16/ RLA File :03/94/040/00692/AM16/ Lic.No/Date:0310801111 16.12.2015 Defer Date: NC in its meeting No.29/82 dated 18.10.2011, uploaded at the end of these minutes or 135

Case No.:8/20/82-ALC4/2015

Party Name:SHREE BANKEY BEHARI LAL BOARD MILLS Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01591/AM16/ RLA File :05/24/040/00427/AM16/ Lic.No/Date:0510396637 16.12.2015 Defer Date: NC in its meeting No.01/82 dated 03.04.2012, uploaded at the end of these minutes or 136

Case No.:83/1/82-ALC1/2016

Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01857/AM16/ RLA File :03/94/040/00752/AM16/ Lic.No/Date:0310801211 18.12.2015 Defer Date: NC in its meeting No.24/82 dated 15.11.2012, uploaded at the end of these minutes or 137

Case No.:14/20/82-ALC4/2015 Party Name:KOPRAN

RESEARCH LABORATORIES LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01597/AM16/ RLA File :03/94/040/00728/AM16/ Lic.No/Date:0310801252 21.12.2015 Defer Date: 12.04.2017 Decision : Information was called for from the firm in NC meeting No.17 dated 24.1.2017 is awaited. The Committee accordingly decided to defer the case.

24 138

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

ORGANIC INDUSTRIES LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01602/AM16/ RLA File :03/95/040/00009/AM16/ Lic.No/Date:0310801275 22.12.2015 Defer Date: 12.04.2017 139

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

ORGANIC INDUSTRIES LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01603/AM16/ RLA File :03/95/040/00267/AM16/ Lic.No/Date:0310801273 22.12.2015 Defer Date: 12.04.2017 140

Case No.:48/20/82-ALC4/2015 Party Name:ALCHEMIE

LABORATORIES Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01631/AM16/ RLA File :03/94/040/00683/AM16/ Lic.No/Date:0310801362 28.12.2015 Defer Date: 12.04.2017 Decision :Deferred for want of comments from DoP. 141

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

PLASTICIZERS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01630/AM16/ RLA File :03/94/040/00792/AM16/ Lic.No/Date:0310801428 31.12.2015 Defer Date: 12.04.2017 142

Case No.:98/20/82-ALC4/2015 Party Name:FRESENIUS

KABI ONCOLOGY LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01681/AM16/ RLA File :05/23/040/00338/AM16/ Lic.No/Date:0510397164 31.12.2015 Defer Date: 12.04.2017 Decision : Information has been received and sent to DoP on 07.03.2017 for comments. 143

Case No.:99/20/82-ALC4/2015 Party Name:JUBILANT LIFE

SCIENCES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01682/AM16/ RLA File :05/23/040/00389/AM16/ Lic.No/Date:0510397158 31.12.2015 Defer Date: NC in its meeting No.01/82 dated 03.04.2012, uploaded at the end of these minutes or 144

Case No.:101/20/82-

ALC4/2015 Party Name:SONGWON SPECIALTY CHEMICALS INDIA PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred

25 HQ File :01/82/050/01684/AM16/ RLA File :34/24/040/00226/AM16/ Lic.No/Date:3410041775 31.12.2015 Defer Date: 12.04.2017 Decision :Deferred. 145

Case No.:119/20/82-

ALC4/2015 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01702/AM16/ RLA File :09/24/040/00582/AM16/ Lic.No/Date:0910063066 31.12.2015 Defer Date: 12.04.2017 Decision :Deferred. 146

Case No.:104/20/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01687/AM16/ RLA File :34/24/040/00253/AM16/ Lic.No/Date:3410041778 04.01.2016 Defer Date: 12.04.2017 Decision :Deferred. 147

Case No.:105/20/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01688/AM16/ RLA File :34/24/040/00252/AM16/ Lic.No/Date:3410041782 05.01.2016 Defer Date: 12.04.2017 Decision :Deferred. 148

Case No.:26/20/82-ALC4/2015 Party Name:AMINES &

Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01609/AM16/ RLA File :03/94/040/00802/AM16/ Lic.No/Date:0310801601 06.01.2016 Defer Date: 12.04.2017 149

Case No.:7/1/82-ALC1/2016

Party Name:PRIVI ORGANICS LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01781/AM16/ RLA File :03/95/040/00688/AM16/ Lic.No/Date:0310801600 06.01.2016 Defer Date: 12.04.2017 150

Case No.:76/20/82-ALC4/2015 Party Name:AIMS IMPEX

PVT. LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01659/AM16/ RLA File :03/94/040/00790/AM16/ Lic.No/Date:0310801644 07.01.2016 Defer Date: 12.04.2017 151 Case No.:103/20/82- Party Name:JUBILANT LIFE Meet No/Date:19/82- Status:

26 ALC4/2015 SCIENCES LIMITED ALC4/2016 08.03.2017 Approved HQ File :01/82/050/01686/AM16/ RLA File :05/23/040/00404/AM16/ Lic.No/Date:0510397232 07.01.2016 Defer Date: NC in its meeting No.01/82 dated 03.04.2012, uploaded at the end of these minutes or 152

Case No.:6/1/82-ALC1/2016

Party Name:MEDISPRAY LABORATORIES PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01780/AM16/ RLA File :03/95/040/00676/AM16/ Lic.No/Date:0310801634 07.01.2016 Defer Date: 12.04.2017 Decision :Deferred for want of comments from DoP. 153

Case No.:32/1/82-ALC1/2016

Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01806/AM16/ RLA File :05/24/040/00431/AM16/ Lic.No/Date:0510397230 07.01.2016 Defer Date NC in its meeting No.08/82 dated 16.09.2015, uploaded at the end of these minutes or 154

Case No.:95/20/82-ALC4/2015 Party Name:SENTISS

PHARMA PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01678/AM16/ RLA File :05/24/040/00499/AM16/ Lic.No/Date:0510397256 08.01.2016 Defer Date: 12.04.2017 Decision : Information called for from the firm in NC meeting No.07/AM17 dated 07.07.2016 is awaited. The committee accordingly deferred the case. 155

Case No.:21/20/82-ALC4/2015 Party Name:SHREE LIFE

SCIENCES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01604/AM16/ RLA File :03/95/040/00762/AM16/ Lic.No/Date:0310801691 11.01.2016 Defer Date: 12.04.2017 156

Case No.:48/1/82-ALC1/2016

Party Name:INDO AMINES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01822/AM16/ RLA File :03/94/040/00785/AM16/ Lic.No/Date:0310801728 12.01.2016 Defer Date: 12.04.2017

27 157

Case No.:82/1/82-ALC1/2016

Party Name:PRIVI ORGANICS LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01856/AM16/ RLA File :03/95/040/00690/AM16/ Lic.No/Date:0310801719 12.01.2016 Defer Date: 12.04.2017 158

Case No.:66/1/82-ALC1/2016

Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01840/AM16/ RLA File :03/94/040/00831/AM16/ Lic.No/Date:0310801850 18.01.2016 Defer Date: 12.04.2017 Decision :Deferred. 159

Case No.:79/1/82-ALC1/2016

Party Name:PRIVI ORGANICS LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01853/AM16/ RLA File :03/95/040/00689/AM16/ Lic.No/Date:0310801831 18.01.2016 Defer Date: 12.04.2017 160

Case No.:59/1/82-ALC1/2016

Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01833/AM16/ RLA File :03/94/040/00589/AM16/ Lic.No/Date:0310801896 19.01.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/453/2014-PI(Norms) dated February. 2015, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 161

Case No.:114/20/82-

ALC4/2015 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01697/AM16/ RLA File :34/24/040/00263/AM16/ Lic.No/Date:3410041814 19.01.2016 Defer Date: 12.04.2017 162

Case No.:50/1/82-ALC1/2016

Party Name:AMINES & Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01824/AM16/ RLA File :03/94/040/00861/AM16/ Lic.No/Date:0310801928 20.01.2016 Defer Date: 12.04.2017 163

Case No.:68/1/82-ALC1/2016

Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred

28 HQ File :01/82/050/01842/AM16/ RLA File :03/94/040/00834/AM16/ Lic.No/Date:0310801927 20.01.2016 Defer Date: 12.04.2017 164

Case No.:106/20/82-

ALC4/2015 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01689/AM16/ RLA File :05/24/040/00515/AM16/ Lic.No/Date:0510397367 20.01.2016 Defer Date: 12.04.2017 Decision : Information called from the firm in NC meeting No.05/82 dated 08.06.2016 is awaited. The Committee accordingly deferred the case. 165

Case No.:38/1/82-ALC1/2016

Party Name:SURVIVAL Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01812/AM16/ RLA File :03/95/040/00798/AM16/ Lic.No/Date:0310801923 20.01.2016 Defer Date: 12.04.2017 166

Case No.:49/1/82-ALC1/2016

Party Name:AMINES & Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01823/AM16/ RLA File :03/94/040/00869/AM16/ Lic.No/Date:0310801950 21.01.2016 Defer Date: 12.04.2017 167

Case No.:72/7/82-ALC4/2016

Party Name:OGENE SYSTEMS INDIA LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00246/AM17/ RLA File :09/24/040/00620/AM16/ Lic.No/Date:0910063151 22.01.2016 Defer Date: 12.04.2017 168

Case No.:88/7/82-ALC4/2016

Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00262/AM17/ RLA File :09/24/040/00304/AM16/ Lic.No/Date:0910063190 29.01.2016 Defer Date: NC in its meeting No.03/82 dated 02.05.2013, uploaded at the end of these minutes or 169

Case No.:27/1/82-ALC1/2016

Party Name:BODAL CHEMICALS LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01801/AM16/ RLA File :08/24/040/00325/AM16/ Lic.No/Date:0810137105 01.02.2016 Defer Date: 12.04.2017

29 170

Case No.:40/1/82-ALC1/2016

Party Name:MAGNOLIA LIMITED. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01814/AM16/ RLA File :03/95/040/01074/AM15/ Lic.No/Date:0310802175 02.02.2016 Defer Date: 12.04.2017 171

Case No.:3/5/82-ALC4/2016

Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00162/AM17/ RLA File :05/24/040/00537/AM16/ Lic.No/Date:0510397479 03.02.2016 Defer Date: NC in its meeting No.12/82 dated 18.11.2015, uploaded at the end of these minutes or 172

Case No.:37/1/82-ALC1/2016

Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01811/AM16/ RLA File :03/95/040/00639/AM16/ Lic.No/Date:0310802231 04.02.2016 Defer Date: 12.04.2017 173

Case No.:43/1/82-ALC1/2016

Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01817/AM16/ RLA File :03/94/040/00882/AM16/ Lic.No/Date:0310802261 05.02.2016 Defer Date: 12.04.2017 174

Case No.:58/1/82-ALC1/2016

Party Name:SURVIVAL Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01832/AM16/ RLA File :03/95/040/00819/AM16/ Lic.No/Date:0310802266 05.02.2016 Defer Date: 12.04.2017 175

Case No.:69/1/82-ALC1/2016

Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01843/AM16/ RLA File :03/94/040/00922/AM16/ Lic.No/Date:0310802291 08.02.2016 Defer Date: 12.04.2017 Decision :Deferred for want of comments from DoP.

30 176

Case No.:74/1/82-ALC1/2016

Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01848/AM16/ RLA File :03/94/040/00810/AM16/ Lic.No/Date:0310802333 08.02.2016 Defer Date: 12.04.2017 177

Case No.:39/1/82-ALC1/2016

Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01813/AM16/ RLA File :03/95/040/00847/AM16/ Lic.No/Date:0310802292 08.02.2016 Defer Date: 12.04.2017 178

Case No.:45/1/82-ALC1/2016

Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01819/AM16/ RLA File :03/94/040/00859/AM16/ Lic.No/Date:0310802380 09.02.2016 Defer Date: 12.04.2017 179

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

Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00253/AM17/ RLA File :09/24/040/00586/AM16/ Lic.No/Date:0910063240 10.02.2016 Defer Date: 12.04.2017 Decision : Information called for from the firm in NC meeting No.09/82 dated 10.08.2016 is awaited. The committee accordingly deferred the case. 180

Case No.:41/1/82-ALC1/2016

Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01815/AM16/ RLA File :03/95/040/00826/AM16/ Lic.No/Date:0310802395 10.02.2016 Defer Date: 12.04.2017 181

Case No.:78/1/82-ALC1/2016

Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01852/AM16/ RLA File :03/95/040/00752/AM16/ Lic.No/Date:0310802451 10.02.2016 Defer Date: 12.04.2017 182

Case No.:26/1/82-ALC1/2016

Party Name:UMA ENTERPRISE Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01800/AM16/ RLA File :08/24/040/00396/AM16/ Lic.No/Date:0810137202 15.02.2016 Defer Date: 12.04.2017

31 183

Case No.:56/1/82-ALC1/2016

Party Name:ZIM LABORATORIES LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01830/AM16/ RLA File :03/95/040/00887/AM16/ Lic.No/Date:0310802649 16.02.2016 Defer Date: 12.04.2017 Decision : Information called for from the firm in NC meeting No.13/82 dated 16.11.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 184

Case No.:17/1/82-ALC1/2016

Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01791/AM16/ RLA File :04/24/040/00229/AM16/ Lic.No/Date:0410161613 17.02.2016 Defer Date: 12.04.2017 185

Case No.:78/7/82-ALC4/2016

Party Name:VIVIMED LABS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00252/AM17/ RLA File :09/24/040/00592/AM16/ Lic.No/Date:0910063303 22.02.2016 Defer Date: NC in its meeting No.19/82 dated 02.01.2014, uploaded at the end of these minutes or 186

Case No.:12/7/82-ALC4/2016

Party Name:MEDICLONE BIO-TECH PRIVATE LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00186/AM17/ RLA File :04/24/040/00250/AM16/ Lic.No/Date:0410161677 01.03.2016 Defer Date: Decision : The Committee decided to ratify norms based on SION A-205 or as applied by the firm whichever is less. RA concerned may take further necessary action as per decision of NC. 187

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

Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00256/AM17/ RLA File :09/24/040/00721/AM16/ Lic.No/Date:0910063357 03.03.2016 Defer Date: 12.04.2017 188

Case No.:59/7/82-ALC4/2016

Party Name:RUCHI SOYA INDUSTRIES LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00233/AM17/ RLA File :56/24/040/00054/AM16/ Lic.No/Date:5610004864 11.03.2016 Defer Date: 12.04.2017

32 189

Case No.:24/2/82-ALC4/2016

Party Name:SCOPE CHEMICALS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00024/AM17/ RLA File :03/95/040/00955/AM16/ Lic.No/Date:0310803229 11.03.2016 Defer Date: 12.04.2017 190

Case No.:100/7/82-ALC4/2016 Party Name:CATAPHARMA

CHEMICALS PVT. LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00274/AM17/ RLA File :31/83/040/00174/AM16/ Lic.No/Date:3110066051 14.03.2016 Defer Date: 12.04.2017 Decision : The Committee decided to advise the firm to appear before NC for Personal Hearing for detail discussion on purity required by the firm. 191

Case No.:15/1/82-ALC1/2016

Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01789/AM16/ RLA File :09/24/040/00713/AM16/ Lic.No/Date:0910063416 15.03.2016 Defer Date: 12.04.2017 Decision : Deferred for want of comments from DoP 192

Case No.:107/7/82-ALC4/2016 Party Name:ASTRAL

STERITECH PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00281/AM17/ RLA File :34/24/040/00345/AM16/ Lic.No/Date:3410041995 21.03.2016 Defer Date: Decision : The Committee decided to ratify norms based on SION A-3672 or as applied decision of NC. 193

Case No.:109/7/82-ALC4/2016 Party Name:BEST VALUE

CHEM PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00283/AM17/ RLA File :34/24/040/00336/AM16/ Lic.No/Date:3410041989 21.03.2016 Defer Date: 12.04.2017 Decision : Deferred 194

Case No.:39/7/82-ALC4/2016

Party Name:POSY PHARMACHEM PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00213/AM17/ RLA File :08/24/040/00426/AM16/ Lic.No/Date:0810137551 30.03.2016 Defer Date: NC in its meeting No.10/82 dated 05.06.2012, uploaded at the end of these minutes or

33 195

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

LABORATORIES LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00312/AM17/ RLA File :03/94/040/01112/AM16/ Lic.No/Date:0310803707 01.04.2016 Defer Date: 12.04.2017 Decision : Deferred for want of comments from DoP 196

Case No.:81/11/82-ALC4/2016 Party Name:J.B. CHEMICALS

& PHARMACEUTICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00615/AM17/ RLA File :03/94/040/01096/AM16/ Lic.No/Date:0310803709 01.04.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/858/2015- PI(Norms) dated 08.09.2016, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 197

Case No.:104/7/82-ALC4/2016 Party Name:JUBILANT

GENERICS LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00278/AM17/ RLA File :05/23/040/00556/AM16/ Lic.No/Date:0510398125 01.04.2016 Defer Date: Decision : The Committee decided to ratify norms based on SION A-412 or as applied decision of NC. 198

Case No.:24/7/82-ALC4/2016

Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00198/AM17/ RLA File :31/83/040/00186/AM16/ Lic.No/Date:3110066111 05.04.2016 Defer Date: 12.04.2017 Decision :Deferred. 199

Case No.:38/7/82-ALC4/2016

Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00212/AM17/ RLA File :05/23/040/00571/AM16/ Lic.No/Date:0510398134 05.04.2016 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/767/2015- PI(Norms) dated June 2016 and 35011/789/2015-PI-Norms dated 18.07.2016, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 200 Case No.:123/7/82-ALC4/2016 Party Name:AARTI Meet No/Date:19/82- Status:

34 INDUSTRIES LIMITED ALC4/2016 08.03.2017 Deferred HQ File :01/82/050/00297/AM17/ RLA File :03/94/040/01038/AM16/ Lic.No/Date:0310803819 06.04.2016 Defer Date: 12.04.2017 Decision : Deferred for want of comments from DoP 201

Case No.:52/7/82-ALC4/2016

Party Name:FINE CURE PHARMACEUTICALS LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00226/AM17/ RLA File :08/24/040/00460/AM16/ Lic.No/Date:0810137652 11.04.2016 Defer Date: 12.04.2017 Decision : The representative of D/o Pharmaceuticals stated in the meeting to call for Master Batch Formula from the firm. The Committee accordingly decided to call for MBF from the firm and deferred the case. 202

Case No.:45/7/82-ALC4/2016

Party Name:ASTRAL STERITECH PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00219/AM17/ RLA File :34/24/040/00009/AM17/ Lic.No/Date:3410042064 13.04.2016 Defer Date: 12.04.2017 203

Case No.:50/7/82-ALC4/2016

Party Name:BODAL CHEMICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00224/AM17/ RLA File :08/24/040/00005/AM17/ Lic.No/Date:0810137692 18.04.2016 Defer Date: 12.04.2017 Decision :Deferred. 204

Case No.:15/7/82-ALC4/2016

Party Name:SUPREET CHEMICALS PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00189/AM17/ RLA File :52/24/040/00006/AM17/ Lic.No/Date:5210041869 25.04.2016 Defer Date: 12.04.2017 Decision :Deferred. 205

Case No.:148/7/82-ALC4/2016 Party Name:HEMA DYE

CHEM PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00322/AM17/ RLA File :03/94/040/00055/AM17/ Lic.No/Date:0310804211 26.04.2016 Defer Date: 12.04.2017 Decision :Deferred. 206

Case No.:2/17/82-ALC4/2016

Party Name:LUPIN LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00963/AM17/ RLA File :03/95/040/00002/AM17/ Lic.No/Date:0310804193 26.04.2016 Defer Date:

35 Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/08/2011-PI(Norms) dated 28.22.2011, as per the details given below or as applied by the firm whichever is less. Export Product Sterile Ceftriaxone sodium 250mg/500mg/1gm/2gm/10gm injection: S. No. Import Item Qty. kg/kg.

1. 7 AMINO CEPHALOSPORANIC ACID 0.668
2. METHYLENE CHLORIDE 2.00
3. 7 AMINO CEPHALOSPORANIC ACID 0.668
4. 2,5,DIHYDRO-6-HYDROXY-3-MERCAPTO-2-METHYL-5-OXO-1,2,4-TRIAZENE 0.360
5. ACETONITRILE 2.60
6. ACETONE 11.50
7. ACTIVATED CARBON 0.100
8. TETRA HYDROFURAN 1.23
9. TRIETHYL AMINE 0.514
10. ISOPROPYL ALCOHOL 0.400 RA concerned may take further necessary action as per the decision of NC 207

Case No.:32/7/82-ALC4/2016

Party Name:HELLO PAINTS (P) LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00206/AM17/ RLA File :05/23/040/00036/AM17/ Lic.No/Date:0510398321 27.04.2016 Defer Date: NC in its meeting No.35/82 dated 29.11.2011, uploaded at the end of these minutes or 208

Case No.:146/7/82-ALC4/2016 Party Name:BDR

PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00320/AM17/ RLA File :03/94/040/00012/AM17/ Lic.No/Date:0310804283 29.04.2016 Defer Date: 12.04.2017 209

Case No.:142/7/82-ALC4/2016 Party Name:KOPRAN

RESEARCH LABORATORIES LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00316/AM17/ RLA File :03/94/040/01101/AM16/ Lic.No/Date:0310804342 02.05.2016 Defer Date: 12.04.2017

36 210

Case No.:49/7/82-ALC4/2016

Party Name:PANACEA BIOTEC LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00223/AM17/ RLA File :05/24/040/00009/AM17/ Lic.No/Date:0510398392 05.05.2016 Defer Date: 12.04.2017 211

Case No.:8/7/82-ALC4/2016

Party Name:STRIDES SHASUN LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00182/AM17/ RLA File :04/24/040/00009/AM17/ Lic.No/Date:0410161871 05.05.2016 Defer Date: 12.04.2017 212

Case No.:9/7/82-ALC4/2016

Party Name:STRIDES SHASUN LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00183/AM17/ RLA File :04/24/040/00010/AM17/ Lic.No/Date:0410161872 05.05.2016 Defer Date: 12.04.2017 213

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

Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00337/AM17/ RLA File :03/94/040/00090/AM17/ Lic.No/Date:0310804480 09.05.2016 Defer Date: 12.04.2017 Decision :Deferred. 214

Case No.:17/7/82-ALC4/2016

Party Name:CONTINENTAL CHEMICALS Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00191/AM17/ RLA File :08/24/040/00045/AM17/ Lic.No/Date:0810137878 09.05.2016 Defer Date: NC in its meeting No.14/82 dated 24.10.2013, uploaded at the end of these minutes or 215

Case No.:18/7/82-ALC4/2016

Party Name:CONTINENTAL CHEMICALS Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00192/AM17/ RLA File :08/24/040/00044/AM17/ Lic.No/Date:0810137877 09.05.2016 Defer Date: 12.04.2017 Decision :Deferred.

37 216

Case No.:51/7/82-ALC4/2016

Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00225/AM17/ RLA File :05/23/040/00539/AM16/ Lic.No/Date:0510398432 09.05.2016 Defer Date: 12.04.2017 Decision :Deferred. 217

Case No.:159/7/82-ALC4/2016 Party Name:BLUE CIRCLE

ORGANICS PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00333/AM17/ RLA File :03/94/040/00061/AM17/ Lic.No/Date:0310804534 10.05.2016 Defer Date: 12.04.2017 Decision :Deferred. 218

Case No.:160/7/82-ALC4/2016 Party Name:BLUE CIRCLE

ORGANICS PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00334/AM17/ RLA File :03/94/040/00036/AM17/ Lic.No/Date:0310804533 10.05.2016 Defer Date: 12.04.2017 Decision :Deferred. 219

Case No.:76/7/82-ALC4/2016

Party Name:FRESENIUS Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00250/AM17/ RLA File :05/23/040/00031/AM17/ Lic.No/Date:0510398443 10.05.2016 Defer Date: 12.04.2017 220

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

INDUSTRIES LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00311/AM17/ RLA File :03/95/040/00763/AM16/ Lic.No/Date:0310804513 10.05.2016 Defer Date: 12.04.2017 Decision :Deferred. 221

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

Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00331/AM17/ RLA File :03/94/040/00122/AM17/ Lic.No/Date:0310804628 12.05.2016 Defer Date: 12.04.2017 222

Case No.:86/11/82-ALC4/2016 Party Name:ALMELO

PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00620/AM17/ RLA File :09/24/040/00056/AM17/ Lic.No/Date:0910063626 17.05.2016 Defer Date: 12.04.2017

38 223

Case No.:85/11/82-ALC4/2016 Party Name:COVALENT

LABORATORIES PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00619/AM17/ RLA File :09/24/040/00028/AM17/ Lic.No/Date:0910063644 17.05.2016 Defer Date: 12.04.2017 224

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

CALCIUM PRIVATE LIMITED, Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01032/AM17/ RLA File :07/24/040/00385/AM16/ Lic.No/Date:0710109823 17.05.2016 Defer Date: 12.04.2017 Decision :Deferred. 225

Case No.:82/11/82-ALC4/2016 Party Name:SENTISS

PHARMA PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00616/AM17/ RLA File :05/24/040/00624/AM16/ Lic.No/Date:0510398507 17.05.2016 Defer Date: 12.04.2017 226

Case No.:83/11/82-ALC4/2016 Party Name:BIOLOGICAL E

LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00617/AM17/ RLA File :09/24/040/00307/AM15/ Lic.No/Date:0910063658 19.05.2016 Defer Date: 12.04.2017 227

Case No.:132/7/82-ALC4/2016 Party Name:SURVIVAL

Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00306/AM17/ RLA File :03/95/040/00118/AM17/ Lic.No/Date:0310804885 20.05.2016 Defer Date: 12.04.2017 Decision :Deferred. 228

Case No.:139/7/82-ALC4/2016 Party Name:GANGWAL

CHEMICALS (P) LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00313/AM17/ RLA File :03/94/040/00149/AM17/ Lic.No/Date:0310804914 23.05.2016 Defer Date: 12.04.2017 Decision :Deferred. 229

Case No.:140/7/82-ALC4/2016 Party Name:GANGWAL

CHEMICALS (P) LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00314/AM17/ RLA File :03/94/040/00148/AM17/ Lic.No/Date:0310804913 23.05.2016 Defer Date: 12.04.2017

39 Decision :Deferred. 230

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

CROPSCIENCE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00327/AM17/ RLA File :03/94/040/00115/AM17/ Lic.No/Date:0310804948 24.05.2016 Defer Date: 12.04.2017 Decision :Deferred. 231

Case No.:134/7/82-ALC4/2016 Party Name:ORBIT LIFE

SCIENCE PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00308/AM17/ RLA File :03/95/040/00069/AM17/ Lic.No/Date:0310804944 24.05.2016 Defer Date: 12.04.2017 232

Case No.:43/10/82-ALC4/2016 Party Name:O C

SPECIALITIES PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00389/AM17/ RLA File :03/95/040/00169/AM17/ Lic.No/Date:0310805124 01.06.2016 Defer Date: 12.04.2017 Decision :Deferred. 233

Case No.:2/11/82-ALC4/2016

Party Name:MANALI PETROCHEMICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00536/AM17/ RLA File :04/24/040/00270/AM16/ Lic.No/Date:0410162005 02.06.2016 Defer Date: 12.04.2017 Decision :Deferred. 234

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

Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00535/AM17/ RLA File :05/23/040/00110/AM17/ Lic.No/Date:0510398726 03.06.2016 Defer Date: Decision : The Committee decided to ratify norms based on SION A-205 or as applied decision of NC. 235

Case No.:8/11/82-ALC4/2016

Party Name:SOFTGEL HEALTH CARE PVT. LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00542/AM17/ RLA File :04/24/040/00042/AM17/ Lic.No/Date:0410162009 03.06.2016 Defer Date: 12.04.2017 236 Case No.:61/11/82-ALC4/2016 Party Name:KEKULE Meet No/Date:19/82- Status:

40 PHARMA LTD ALC4/2016 08.03.2017 Deferred HQ File :01/82/050/00595/AM17/ RLA File :09/24/040/00017/AM17/ Lic.No/Date:0910063781 09.06.2016 Defer Date: 12.04.2017 237

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

CHEMICAL INDUSTRIES LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00657/AM17/ RLA File :34/24/040/00068/AM17/ Lic.No/Date:3410042260 10.06.2016 Defer Date: 12.04.2017 Decision :Deferred. 238

Case No.:62/11/82-ALC4/2016 Party Name:SALICYLATES &

CHEMICALS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00596/AM17/ RLA File :09/24/040/00077/AM17/ Lic.No/Date:0910063788 10.06.2016 Defer Date: 12.04.2017 Decision :Deferred. 239

Case No.:64/11/82-ALC4/2016 Party Name:SALICYLATES &

CHEMICALS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00598/AM17/ RLA File :09/24/040/00076/AM17/ Lic.No/Date:0910063789 10.06.2016 Defer Date: 12.04.2017 Decision :Deferred. 240

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

ENTERPRISE Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00717/AM17/ RLA File :08/24/040/00099/AM17/ Lic.No/Date:0810138154 10.06.2016 Defer Date: 12.04.2017 Decision :Deferred. 241

Case No.:1/7/82-ALC4/2016

Party Name:NEULAND LABORATORIES LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00175/AM17/ RLA File :09/24/040/00139/AM17/ Lic.No/Date:0910063809 21.06.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/500/2013-PI(Norms) dated 21.10.2013, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 242

Case No.:5/11/82-ALC4/2016

Party Name:ASCENT FINECHEM PVT. LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File RLA File Lic.No/Date:0810138218 Defer Date:

41 :01/82/050/00539/AM17/ :08/24/040/00104/AM17/ 28.06.2016 12.04.2017 243

Case No.:16/11/82-ALC4/2016 Party Name:PERFECT

VITAMINS PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00550/AM17/ RLA File :03/95/040/00255/AM17/ Lic.No/Date:0310805798 29.06.2016 Defer Date: 12.04.2017 Decision :Deferred. 244

Case No.:198/17/82-

ALC4/2016 Party Name:NASENSE LABS PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01159/AM17/ RLA File :09/24/040/00172/AM17/ Lic.No/Date:0910063874 30.06.2016 Defer Date: 12.04.2017 245

Case No.:184/17/82-

ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01145/AM17/ RLA File :09/24/040/00143/AM17/ Lic.No/Date:0910063875 30.06.2016 Defer Date: 12.04.2017 246

Case No.:7/11/82-ALC4/2016

Party Name:PANERA BIOTEC PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00541/AM17/ RLA File :05/24/040/00136/AM17/ Lic.No/Date:0510398951 30.06.2016 Defer Date: 12.04.2017 247

Case No.:185/17/82-

ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01146/AM17/ RLA File :09/24/040/00147/AM17/ Lic.No/Date:0910063885 04.07.2016 Defer Date: 12.04.2017 248

Case No.:14/11/82-ALC4/2016 Party Name:PALADIN

PAINTS AND CHEMICALS PVT. LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00548/AM17/ RLA File :03/95/040/00277/AM17/ Lic.No/Date:0310805923 04.07.2016 Defer Date: 12.04.2017 Decision :Deferred. 249 Case No.:50/11/82-ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:19/82- ALC4/2016 Status: Deferred

42 08.03.2017 HQ File :01/82/050/00584/AM17/ RLA File :03/94/040/00275/AM17/ Lic.No/Date:0310805959 05.07.2016 Defer Date: 12.04.2017 250

Case No.:53/11/82-ALC4/2016 Party Name:ENCUBE

ETHICALS PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00587/AM17/ RLA File :03/94/040/00273/AM17/ Lic.No/Date:0310805958 05.07.2016 Defer Date: 12.04.2017 251

Case No.:48/11/82-ALC4/2016 Party Name:J.B. CHEMICALS

& PHARMACEUTICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00582/AM17/ RLA File :03/94/040/00255/AM17/ Lic.No/Date:0310805960 05.07.2016 Defer Date: 12.04.2017 252

Case No.:3/13/82-ALC4/2016

Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00631/AM17/ RLA File :05/24/040/00143/AM17/ Lic.No/Date:0510399022 06.07.2016 Defer Date: 12.04.2017 253

Case No.:39/13/82-ALC4/2016 Party Name:VIRDEV

INTERMEDIATES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00667/AM17/ RLA File :52/24/040/00022/AM17/ Lic.No/Date:5210041951 08.07.2016 Defer Date: 12.04.2017 254

Case No.:1/13/82-ALC4/2016

Party Name:FRESENIUS Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00629/AM17/ RLA File :05/23/040/00168/AM17/ Lic.No/Date:0510399049 11.07.2016 Defer Date: 12.04.2017 255

Case No.:13/11/82-ALC4/2016 Party Name:S M CHEMICAL

VAPI PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00547/AM17/ RLA File :03/95/040/00225/AM17/ Lic.No/Date:0310806063 11.07.2016 Defer Date: 12.04.2017 Decision :Deferred.

43 256

Case No.:42/11/82-ALC4/2016 Party Name:AARTI

INDUSTRIES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00576/AM17/ RLA File :03/94/040/00198/AM17/ Lic.No/Date:0310806121 12.07.2016 Defer Date: 12.04.2017 257

Case No.:43/11/82-ALC4/2016 Party Name:AARTI

INDUSTRIES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00577/AM17/ RLA File :03/94/040/00105/AM17/ Lic.No/Date:0310806120 12.07.2016 Defer Date: 12.04.2017 258

Case No.:40/11/82-ALC4/2016 Party Name:ETERNIS FINE

CHEMICALS LIMITED, Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00574/AM17/ RLA File :03/94/040/00237/AM17/ Lic.No/Date:0310806115 12.07.2016 Defer Date: 12.04.2017 259

Case No.:52/11/82-ALC4/2016 Party Name:J.B. CHEMICALS

& PHARMACEUTICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00586/AM17/ RLA File :03/94/040/00288/AM17/ Lic.No/Date:0310806113 12.07.2016 Defer Date: 12.04.2017 260

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

& PHARMACEUTICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00660/AM17/ RLA File :03/94/040/00291/AM17/ Lic.No/Date:0310806165 12.07.2016 Defer Date: 12.04.2017 261

Case No.:89/11/82-ALC4/2016 Party Name:MALWA

OXYGEN & INDUSTRIAL GASES PVT.LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00623/AM17/ RLA File :56/24/040/00015/AM17/ Lic.No/Date:5610004949 12.07.2016 Defer Date: 12.04.2017 Decision :Deferred. 262

Case No.:57/11/82-ALC4/2016 Party Name:ZIM

LABORATORIES LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00591/AM17/ RLA File :03/95/040/00296/AM17/ Lic.No/Date:0310806194 13.07.2016 Defer Date: 12.04.2017

44 263

Case No.:68/11/82-ALC4/2016 Party Name:CADILA

HEALTHCARE LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00602/AM17/ RLA File :08/24/040/00116/AM17/ Lic.No/Date:0810138288 14.07.2016 Defer Date: 12.04.2017 264

Case No.:10/11/82-ALC4/2016 Party Name:MATRIX FINE

SCIENCES PVT.LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00544/AM17/ RLA File :03/95/040/00304/AM17/ Lic.No/Date:0310806238 14.07.2016 Defer Date: 12.04.2017 265

Case No.:56/11/82-ALC4/2016 Party Name:NEOGEN

CHEMICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00590/AM17/ RLA File :03/95/040/00746/AM16/ Lic.No/Date:0310806245 14.07.2016 Defer Date: 12.04.2017 Decision :Deferred. 266

Case No.:54/11/82-ALC4/2016 Party Name:SWISS

PARENTERALS PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00588/AM17/ RLA File :08/24/040/00138/AM17/ Lic.No/Date:0810138287 14.07.2016 Defer Date: Decision : The Committee decided to ratify norms based on SION A-205 or as applied decision of NC. 267

Case No.:72/11/82-ALC4/2016 Party Name:CADILA

HEALTHCARE LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00606/AM17/ RLA File :08/24/040/00145/AM17/ Lic.No/Date:0810138301 15.07.2016 Defer Date: 12.04.2017 268

Case No.:67/11/82-ALC4/2016 Party Name:FRESENIUS

Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00601/AM17/ RLA File :05/23/040/00065/AM17/ Lic.No/Date:0510399129 19.07.2016 Defer Date: 12.04.2017 269

Case No.:66/11/82-ALC4/2016 Party Name:JUBILANT LIFE

SCIENCES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred

45 HQ File :01/82/050/00600/AM17/ RLA File :05/23/040/00147/AM17/ Lic.No/Date:0510399130 19.07.2016 Defer Date: 12.04.2017 Decision :Deferred. 270

Case No.:21/11/82-ALC4/2016 Party Name:NEOGEN

CHEMICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00555/AM17/ RLA File :03/95/040/00206/AM17/ Lic.No/Date:0310806373 19.07.2016 Defer Date: 12.04.2017 Decision :Deferred. 271

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

SPECIALTIES LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00552/AM17/ RLA File :03/95/040/00262/AM17/ Lic.No/Date:0310806401 19.07.2016 Defer Date: 12.04.2017 272

Case No.:35/11/82-ALC4/2016 Party Name:AARTI

INDUSTRIES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00569/AM17/ RLA File :03/94/040/00283/AM17/ Lic.No/Date:0310806427 20.07.2016 Defer Date: 12.04.2017 Decision :Deferred for want of comments from DoP. 273

Case No.:74/11/82-ALC4/2016 Party Name:KLJ

Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00608/AM17/ RLA File :05/23/040/00195/AM17/ Lic.No/Date:0510399160 20.07.2016 Defer Date: 12.04.2017 Decision :Deferred. 274

Case No.:19/11/82-ALC4/2016 Party Name:REANNON

PHARMACEUTICALS Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00553/AM17/ RLA File :03/95/040/00326/AM17/ Lic.No/Date:0310806484 21.07.2016 Defer Date: 12.04.2017 275

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

PHARMACEUTICALS Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00711/AM17/ RLA File :03/95/040/00327/AM17/ Lic.No/Date:0310806482 21.07.2016 Defer Date: 12.04.2017 276 Case No.:25/11/82-ALC4/2016 Party Name:STERLING Meet No/Date:19/82- Status:

46 AUXILIARIES PVT LTD ALC4/2016 08.03.2017 Deferred HQ File :01/82/050/00559/AM17/ RLA File :03/95/040/00180/AM17/ Lic.No/Date:0310806477 21.07.2016 Defer Date: 12.04.2017 Decision :Deferred. 277

Case No.:26/11/82-ALC4/2016 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00560/AM17/ RLA File :03/95/040/00116/AM17/ Lic.No/Date:0310806480 21.07.2016 Defer Date: 12.04.2017 Decision :Deferred. 278

Case No.:27/11/82-ALC4/2016 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00561/AM17/ RLA File :03/95/040/00143/AM17/ Lic.No/Date:0310806474 21.07.2016 Defer Date: 12.04.2017 Decision :Deferred. 279

Case No.:20/13/82-ALC4/2016 Party Name:FRESENIUS

Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00648/AM17/ RLA File :05/23/040/00211/AM17/ Lic.No/Date:0510399202 22.07.2016 Defer Date: 12.04.2017 280

Case No.:20/11/82-ALC4/2016 Party Name:NEOGEN

CHEMICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00554/AM17/ RLA File :03/95/040/00498/AM16/ Lic.No/Date:0310806509 22.07.2016 Defer Date: 12.04.2017 Decision :Deferred. 281

Case No.:31/11/82-ALC4/2016 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00565/AM17/ RLA File :03/95/040/00168/AM17/ Lic.No/Date:0310806532 22.07.2016 Defer Date: 12.04.2017 282

Case No.:7/13/82-ALC4/2016

Party Name:STYRAX PHARMA PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00635/AM17/ RLA File :26/24/040/00013/AM17/ Lic.No/Date:2610012765 22.07.2016 Defer Date: 12.04.2017 Decision :Deferred.

47 283

Case No.:70/11/82-ALC4/2016 Party Name:ARCHI EXIM

PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00604/AM17/ RLA File :08/24/040/00150/AM17/ Lic.No/Date:0810138353 25.07.2016 Defer Date: 12.04.2017 Decision : 284

Case No.:71/11/82-ALC4/2016 Party Name:ARCHI EXIM

PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00605/AM17/ RLA File :08/24/040/00151/AM17/ Lic.No/Date:0810138354 25.07.2016 Defer Date: 12.04.2017 285

Case No.:144/13/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00772/AM17/ RLA File :08/24/040/00154/AM17/ Lic.No/Date:0810138352 25.07.2016 Defer Date: 12.04.2017 286

Case No.:32/11/82-ALC4/2016 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00566/AM17/ RLA File :03/95/040/00290/AM17/ Lic.No/Date:0310806544 25.07.2016 Defer Date: 12.04.2017 Decision :Deferred. 287

Case No.:55/11/82-ALC4/2016 Party Name:SWISS

PARENTERALS PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00589/AM17/ RLA File :08/24/040/00156/AM17/ Lic.No/Date:0810138362 25.07.2016 Defer Date: 12.04.2017 288

Case No.:22/11/82-ALC4/2016 Party Name:ENCUBE

ETHICALS PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00556/AM17/ RLA File :03/94/040/00262/AM17/ Lic.No/Date:0310806600 26.07.2016 Defer Date: 12.04.2017 289

Case No.:77/11/82-ALC4/2016 Party Name:ASIATIC DRUGS

&PHARMACEUTICALS PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00611/AM17/ RLA File :05/23/040/00124/AM17/ Lic.No/Date:0510399240 27.07.2016 Defer Date: 12.04.2017

48 290

Case No.:78/11/82-ALC4/2016 Party Name:ASIATIC DRUGS

&PHARMACEUTICALS PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00612/AM17/ RLA File :05/23/040/00123/AM17/ Lic.No/Date:0510399239 27.07.2016 Defer Date: 12.04.2017 291

Case No.:79/11/82-ALC4/2016 Party Name:ASIATIC DRUGS

&PHARMACEUTICALS PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00613/AM17/ RLA File :05/23/040/00119/AM17/ Lic.No/Date:0510399242 27.07.2016 Defer Date: 12.04.2017 292

Case No.:80/11/82-ALC4/2016 Party Name:ASIATIC DRUGS

&PHARMACEUTICALS PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00614/AM17/ RLA File :05/23/040/00125/AM17/ Lic.No/Date:0510399241 27.07.2016 Defer Date: 12.04.2017 293

Case No.:67/13/82-ALC4/2016 Party Name:BDR

PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00695/AM17/ RLA File :03/94/040/00335/AM17/ Lic.No/Date:0310806658 27.07.2016 Defer Date: 12.04.2017 294

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

PETROCHEM PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00712/AM17/ RLA File :05/24/040/00170/AM17/ Lic.No/Date:0510399250 27.07.2016 Defer Date: 12.04.2017 Decision :Deferred. 295

Case No.:64/13/82-ALC4/2016 Party Name:AARTI

INDUSTRIES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00692/AM17/ RLA File :03/94/040/00177/AM17/ Lic.No/Date:0310806697 28.07.2016 Defer Date: 12.04.2017 296

Case No.:71/13/82-ALC4/2016 Party Name:CIRON DRUGS &

PHARMACEUTICALS P. LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved

49 HQ File :01/82/050/00699/AM17/ RLA File :03/94/040/00312/AM17/ Lic.No/Date:0310806768 01.08.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/648/2015-PI(Norms) dated November 2014, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 297

Case No.:112/17/82-

ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01073/AM17/ RLA File :07/24/040/00153/AM17/ Lic.No/Date:0710110200 04.08.2016 Defer Date: 12.04.2017 Decision :Deferred. 298

Case No.:73/13/82-ALC4/2016 Party Name:ELPPE

CHEMICALS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00701/AM17/ RLA File :03/94/040/00354/AM17/ Lic.No/Date:0310806872 05.08.2016 Defer Date: 12.04.2017 Decision :Deferred. 299

Case No.:72/13/82-ALC4/2016 Party Name:INVENTIA

HEALTHCARE PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00700/AM17/ RLA File :03/94/040/00356/AM17/ Lic.No/Date:0310806927 08.08.2016 Defer Date: Decision : The Committee decided to ratify norms based on SION A-412 or as applied decision of NC. 300

Case No.:49/13/82-ALC4/2016 Party Name:ALTA

LABORATORIES LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00677/AM17/ RLA File :03/94/040/01052/AM16/ Lic.No/Date:0310806947 09.08.2016 Defer Date: NC in its meeting No.42/82 dated 18.01.2011, uploaded at the end of these minutes or as as per the decision of NC. 301

Case No.:50/13/82-ALC4/2016 Party Name:DELTA

FINOCHEM PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00678/AM17/ RLA File :03/94/040/00286/AM17/ Lic.No/Date:0310806966 09.08.2016 Defer Date: 12.04.2017

50 302

Case No.:10/13/82-ALC4/2016 Party Name:FRESENIUS

Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00638/AM17/ RLA File :05/23/040/00229/AM17/ Lic.No/Date:0510399392 09.08.2016 Defer Date: 12.04.2017 303

Case No.:100/17/82-

ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01061/AM17/ RLA File :07/24/040/00154/AM17/ Lic.No/Date:0710110231 09.08.2016 Defer Date: 12.04.2017 Decision :Deferred. 304

Case No.:113/17/82-

ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01074/AM17/ RLA File :07/24/040/00155/AM17/ Lic.No/Date:0710110232 09.08.2016 Defer Date: 12.04.2017 Decision :Deferred. 305

Case No.:48/13/82-ALC4/2016 Party Name:HUBERGROUP

INDIA PRIVATE LIMITED. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00676/AM17/ RLA File :03/94/040/00386/AM17/ Lic.No/Date:0310806969 09.08.2016 Defer Date: 12.04.2017 Decision :Deferred. 306

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

ALATHUR) PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00654/AM17/ RLA File :04/24/040/00065/AM17/ Lic.No/Date:0410162171 09.08.2016 Defer Date: 12.04.2017 Decision :Deferred. 307

Case No.:1/15/82-ALC4/2016

Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00815/AM17/ RLA File :05/23/040/00226/AM17/ Lic.No/Date:0510399403 10.08.2016 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/298/2015- PI(Norms) dated Oct. 2015, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 308 Case No.:41/13/82-ALC4/2016 Party Name:VIRDEV INTERMEDIATES PVT LTD Meet No/Date:19/82- ALC4/2016 Status: Approved

51 08.03.2017 HQ File :01/82/050/00669/AM17/ RLA File :52/24/040/00031/AM17/ Lic.No/Date:5210041993 10.08.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/825/2015-PI(Norms) dated 01.06.2016, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 309

Case No.:17/13/82-ALC4/2016 Party Name:HELLO PAINTS

(P) LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00645/AM17/ RLA File :05/23/040/00220/AM17/ Lic.No/Date:0510399449 11.08.2016 Defer Date: 12.04.2017 Decision :Deferred. 310

Case No.:76/13/82-ALC4/2016 Party Name:JINDAL DRUGS

PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00704/AM17/ RLA File :03/94/040/00391/AM17/ Lic.No/Date:0310807030 11.08.2016 Defer Date: 12.04.2017 Decision :Deferred. 311

Case No.:18/13/82-ALC4/2016 Party Name:JUBILANT LIFE

SCIENCES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00646/AM17/ RLA File :05/23/040/00230/AM17/ Lic.No/Date:0510399442 11.08.2016 Defer Date: 12.04.2017 Decision :Deferred. 312

Case No.:61/13/82-ALC4/2016 Party Name:S M B

CORPORATION OF INDIA Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00689/AM17/ RLA File :03/95/040/00388/AM17/ Lic.No/Date:0310807070 11.08.2016 Defer Date: 12.04.2017 313

Case No.:78/13/82-ALC4/2016 Party Name:AARTI

INDUSTRIES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00706/AM17/ RLA File :03/94/040/00371/AM17/ Lic.No/Date:0310807104 12.08.2016 Defer Date: 12.04.2017 314

Case No.:12/13/82-ALC4/2016 Party Name:CADILA

HEALTHCARE LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00640/AM17/ RLA File :08/24/040/00196/AM17/ Lic.No/Date:0810138482 12.08.2016 Defer Date: 12.04.2017

52 315

Case No.:15/13/82-ALC4/2016 Party Name:TORRENT

PHARMACEUTICALS LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00643/AM17/ RLA File :08/24/040/00184/AM17/ Lic.No/Date:0810138477 12.08.2016 Defer Date: Decision : The Committee decided to ratify norms based on SION A-412 or as applied decision of NC. 316

Case No.:53/13/82-ALC4/2016 Party Name:CORAL

LABORATORIES LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00681/AM17/ RLA File :03/94/040/00421/AM17/ Lic.No/Date:0310807134 16.08.2016 Defer Date: Decision : The Committee decided to ratify norms based on SION A-3647, 3648 or as 317

Case No.:190/17/82-

ALC4/2016 Party Name:GLAND PHARMA LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01151/AM17/ RLA File :09/24/040/00223/AM17/ Lic.No/Date:0910064041 16.08.2016 Defer Date: 12.04.2017 318

Case No.:14/13/82-ALC4/2016 Party Name:GOPINATH

CHEM-TECH LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00642/AM17/ RLA File :08/24/040/00181/AM17/ Lic.No/Date:0810138489 16.08.2016 Defer Date: 12.04.2017 Decision :Deferred. 319

Case No.:16/13/82-ALC4/2016 Party Name:GOPINATH

CHEM-TECH LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00644/AM17/ RLA File :08/24/040/00191/AM17/ Lic.No/Date:0810138490 16.08.2016 Defer Date: 12.04.2017 Decision :Deferred. 320

Case No.:11/13/82-ALC4/2016 Party Name:CADILA

HEALTHCARE LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00639/AM17/ RLA File :08/24/040/00190/AM17/ Lic.No/Date:0810138500 17.08.2016 Defer Date: 12.04.2017

53 321

Case No.:52/13/82-ALC4/2016 Party Name:KAIRAV

CHEMOFARBE INDUSTRIES LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00680/AM17/ RLA File :03/94/040/00160/AM17/ Lic.No/Date:0310807167 17.08.2016 Defer Date: 12.04.2017 Decision :Deferred. 322

Case No.:40/13/82-ALC4/2016 Party Name:AETHER

INDUSTRIES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00668/AM17/ RLA File :52/24/040/00036/AM17/ Lic.No/Date:5210042006 19.08.2016 Defer Date: 12.04.2017 Decision :Deferred. 323

Case No.:19/13/82-ALC4/2016 Party Name:FRESENIUS

Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00647/AM17/ RLA File :05/23/040/00234/AM17/ Lic.No/Date:0510399492 19.08.2016 Defer Date: 12.04.2017 324

Case No.:142/13/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00770/AM17/ RLA File :05/24/040/00226/AM17/ Lic.No/Date:0510399509 19.08.2016 Defer Date: 12.04.2017 325

Case No.:150/13/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00778/AM17/ RLA File :05/24/040/00201/AM17/ Lic.No/Date:0510399507 19.08.2016 Defer Date: 12.04.2017 Decision : The Committee decided to call for information from the firm based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/781/2015- PI(Norms) dated 26.04.2016, uploaded at the end of these minutes and deferred the case. 326

Case No.:152/13/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00780/AM17/ RLA File :05/24/040/00200/AM17/ Lic.No/Date:0510399505 19.08.2016 Defer Date: 12.04.2017 Decision : The Committee decided to call for information from the firm based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/781/2015- PI(Norms) dated 26.04.2016, uploaded at the end of these minutes and deferred the case. 327 Case No.:7/17/82-ALC4/2016 Party Name:AMINES & Meet No/Date:19/82- Status:

54 ALC4/2016 08.03.2017 Deferred HQ File :01/82/050/00968/AM17/ RLA File :03/94/040/00437/AM17/ Lic.No/Date:0310807244 22.08.2016 Defer Date: 12.04.2017 Decision :Deferred. 328

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

& PHARMACEUTICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00697/AM17/ RLA File :03/94/040/00339/AM17/ Lic.No/Date:0310807289 22.08.2016 Defer Date: 12.04.2017 329

Case No.:112/13/82-

ALC4/2016 Party Name:AIMS IMPEX PVT. LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00740/AM17/ RLA File :03/94/040/00436/AM17/ Lic.No/Date:0310807309 23.08.2016 Defer Date: 12.04.2017 330

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

& PHARMACEUTICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00696/AM17/ RLA File :03/94/040/00453/AM17/ Lic.No/Date:0310807316 23.08.2016 Defer Date: 12.04.2017 331

Case No.:156/13/82-

ALC4/2016 Party Name:MAHIMA LIFE SCIENCES PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00784/AM17/ RLA File :05/24/040/00214/AM17/ Lic.No/Date:0510399536 23.08.2016 Defer Date: 12.04.2017 332

Case No.:157/13/82-

ALC4/2016 Party Name:MAHIMA LIFE SCIENCES PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00785/AM17/ RLA File :05/24/040/00215/AM17/ Lic.No/Date:0510399537 23.08.2016 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/119/2016- PI(Norms) dated July 2016, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 333

Case No.:141/13/82-

ALC4/2016 Party Name:RHYDBURG PHARMACEUTICALS LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred

55 HQ File :01/82/050/00769/AM17/ RLA File :05/24/040/00239/AM17/ Lic.No/Date:0510399535 23.08.2016 Defer Date: 12.04.2017 334

Case No.:75/13/82-ALC4/2016 Party Name:ANUH PHARMA

LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00703/AM17/ RLA File :03/94/040/00456/AM17/ Lic.No/Date:0310807339 24.08.2016 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/210/2014- PI(Norms) dated Oct. 2014, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 335

Case No.:212/17/82-

ALC4/2016 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01173/AM17/ RLA File :09/24/040/00268/AM17/ Lic.No/Date:0910064076 25.08.2016 Defer Date recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/139/2016- PI(Norms) dated August 2016, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 336

Case No.:94/13/82-ALC4/2016 Party Name:BODAL

CHEMICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00722/AM17/ RLA File :08/24/040/00137/AM17/ Lic.No/Date:0810138556 29.08.2016 Defer Date: 12.04.2017 Decision :Deferred. 337

Case No.:161/13/82-

ALC4/2016 Party Name:FRESENIUS Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00789/AM17/ RLA File :05/23/040/00251/AM17/ Lic.No/Date:0510399568 29.08.2016 Defer Date: 12.04.2017 338

Case No.:123/13/82-

ALC4/2016 Party Name:D. R. COATS INK & RESINS PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00751/AM17/ RLA File :03/94/040/00265/AM17/ Lic.No/Date:0310807443 30.08.2016 Defer Date: 12.04.2017 Decision :Deferred.

56 339

Case No.:81/13/82-ALC4/2016 Party Name:PANACEA

BIOTEC LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00709/AM17/ RLA File :05/24/040/00258/AM17/ Lic.No/Date:0510399580 30.08.2016 Defer Date: 12.04.2017 340

Case No.:132/13/82-

ALC4/2016 Party Name:ZIM LABORATORIES LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00760/AM17/ RLA File :03/95/040/00448/AM17/ Lic.No/Date:0310807505 31.08.2016 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/766/2015- PI(Norms) dated 26.04.2016, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 341

Case No.:124/13/82-

ALC4/2016 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00752/AM17/ RLA File :03/94/040/00464/AM17/ Lic.No/Date:0310807534 01.09.2016 Defer Date: 12.04.2017 Decision :Deferred. 342

Case No.:121/13/82-

ALC4/2016 Party Name:GOPALDAS VISRAM & CO.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00749/AM17/ RLA File :03/94/040/00469/AM17/ Lic.No/Date:0310807553 01.09.2016 Defer Date: 12.04.2017 Decision : The Committee decided to call for information from the firm based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/478/2013- PI(Norms) dated August 2014, uploaded at the end of these minutes and deferred the case. 343

Case No.:163/13/82-

ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00791/AM17/ RLA File :09/24/040/00285/AM17/ Lic.No/Date:0910064084 01.09.2016 Defer Date: 12.04.2017 344

Case No.:164/13/82-

ALC4/2016 LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00792/AM17/ RLA File :09/24/040/00311/AM17/ Lic.No/Date:0910064091 01.09.2016 Defer Date: 12.04.2017

57 345

Case No.:168/13/82-

ALC4/2016 LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00796/AM17/ RLA File :09/24/040/00301/AM17/ Lic.No/Date:0910064085 01.09.2016 Defer Date: 12.04.2017 346

Case No.:170/13/82-

ALC4/2016 LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00798/AM17/ RLA File :09/24/040/00284/AM17/ Lic.No/Date:0910064083 01.09.2016 Defer Date: 12.04.2017 347

Case No.:196/17/82-

ALC4/2016 Party Name:ORCH LABORATORIES INDIA PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01157/AM17/ RLA File :09/24/040/00292/AM17/ Lic.No/Date:0910064089 01.09.2016 Defer Date: 12.04.2017 348

Case No.:95/13/82-ALC4/2016 Party Name:ACULIFE

HEALTHCARE PRIVATE LIMITED, Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00723/AM17/ RLA File :08/24/040/00161/AM17/ Lic.No/Date:0810138597 02.09.2016 Defer Date: 12.04.2017 349

Case No.:143/13/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00771/AM17/ RLA File :08/24/040/00124/AM17/ Lic.No/Date:0810138603 02.09.2016 Defer Date: 12.04.2017 350

Case No.:146/13/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00774/AM17/ RLA File :22/24/040/00046/AM17/ Lic.No/Date:2210015557 02.09.2016 Defer Date: 12.04.2017 351

Case No.:122/13/82-

ALC4/2016 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00750/AM17/ RLA File :03/94/040/00374/AM17/ Lic.No/Date:0310807578 02.09.2016 Defer Date: 12.04.2017

58 Decision :Deferred. 352

Case No.:145/13/82-

ALC4/2016 Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00773/AM17/ RLA File :22/24/040/00049/AM17/ Lic.No/Date:2210015554 02.09.2016 Defer Date: Decision : The Committee decided to ratify norms based on SION A-3672 or as applied decision of NC. 353

Case No.:109/13/82-

ALC4/2016 Party Name:AURA PHARMACEUTICALS PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00737/AM17/ RLA File :03/94/040/00484/AM17/ Lic.No/Date:0310807613 06.09.2016 Defer Date: 12.04.2017 354

Case No.:131/13/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00759/AM17/ RLA File :03/95/040/00248/AM17/ Lic.No/Date:0310807651 07.09.2016 Defer Date: decision taken by NC in it meeting No.36/82 dated 07.12.2010, uploaded at the end of 355

Case No.:135/13/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00763/AM17/ RLA File :03/95/040/00247/AM17/ Lic.No/Date:0310807650 07.09.2016 Defer Date: decision taken by NC in it meeting No.36/82 dated 07.12.2010, uploaded at the end of 356

Case No.:136/13/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00764/AM17/ RLA File :03/95/040/00311/AM17/ Lic.No/Date:0310807649 07.09.2016 Defer Date: decision taken by NC in it meeting No.21/82 dated 04.10.2012, uploaded at the end of

59 357

Case No.:202/17/82-

ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01163/AM17/ RLA File :09/24/040/00286/AM17/ Lic.No/Date:0910064118 08.09.2016 Defer Date: 12.04.2017 358

Case No.:197/17/82-

ALC4/2016 Party Name:EYTAN LABS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01158/AM17/ RLA File :09/24/040/00252/AM17/ Lic.No/Date:0910064110 08.09.2016 Defer Date: 12.04.2017 359

Case No.:167/13/82-

ALC4/2016 LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00795/AM17/ RLA File :09/24/040/00300/AM17/ Lic.No/Date:0910064112 08.09.2016 Defer Date: 12.04.2017 360

Case No.:169/13/82-

ALC4/2016 LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00797/AM17/ RLA File :09/24/040/00302/AM17/ Lic.No/Date:0910064113 08.09.2016 Defer Date: 12.04.2017 361

Case No.:209/17/82-

ALC4/2016 Party Name:INTERNATIONAL HEALTHCARE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01170/AM17/ RLA File :09/24/040/00246/AM17/ Lic.No/Date:0910064103 08.09.2016 Defer Date: 12.04.2017 362

Case No.:108/13/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00736/AM17/ RLA File :03/94/040/00506/AM17/ Lic.No/Date:0310807686 08.09.2016 Defer Date: 12.04.2017 363

Case No.:207/17/82-

ALC4/2016 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01168/AM17/ RLA File :09/24/040/00310/AM17/ Lic.No/Date:0910064117 08.09.2016 Defer Date: 12.04.2017

60 364

Case No.:137/13/82-

ALC4/2016 Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00765/AM17/ RLA File :03/95/040/00437/AM17/ Lic.No/Date:0310807709 08.09.2016 Defer Date: 12.04.2017 Decision :Deferred. 365

Case No.:186/17/82-

ALC4/2016 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01147/AM17/ RLA File :09/24/040/00231/AM17/ Lic.No/Date:0910064100 08.09.2016 Defer Date: 12.04.2017 Decision :Deferred. 366

Case No.:199/17/82-

ALC4/2016 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01160/AM17/ RLA File :09/24/040/00075/AM17/ Lic.No/Date:0910064099 08.09.2016 Defer Date: 12.04.2017 Decision :Deferred. 367

Case No.:159/13/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00787/AM17/ RLA File :05/24/040/00264/AM17/ Lic.No/Date:0510399649 08.09.2016 Defer Date: 12.04.2017 368

Case No.:208/17/82-

ALC4/2016 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01169/AM17/ RLA File :09/24/040/00256/AM17/ Lic.No/Date:0910064101 08.09.2016 Defer Date: 12.04.2017 369

Case No.:162/13/82-

ALC4/2016 Party Name:HETERO DRUGS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00790/AM17/ RLA File :09/24/040/00309/AM17/ Lic.No/Date:0910064122 09.09.2016 Defer Date: 12.04.2017 370

Case No.:166/13/82-

ALC4/2016 LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00794/AM17/ RLA File :09/24/040/00314/AM17/ Lic.No/Date:0910064123 09.09.2016 Defer Date: 12.04.2017

61 371

Case No.:165/13/82-

ALC4/2016 Party Name:HONOUR LAB LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00793/AM17/ RLA File :09/24/040/00321/AM17/ Lic.No/Date:0910064126 09.09.2016 Defer Date: 12.04.2017 372

Case No.:206/17/82-

ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01167/AM17/ RLA File :09/24/040/00277/AM17/ Lic.No/Date:0910064133 12.09.2016 Defer Date: 12.04.2017 373

Case No.:93/13/82-ALC4/2016 Party Name:MAHIMA LIFE

SCIENCES PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00721/AM17/ RLA File :05/24/040/00217/AM17/ Lic.No/Date:0510399726 15.09.2016 Defer Date: 12.04.2017 374

Case No.:105/13/82-

ALC4/2016 Party Name:AARTI DRUGS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00733/AM17/ RLA File :03/94/040/00487/AM17/ Lic.No/Date:0310807836 16.09.2016 Defer Date: 12.04.2017 375

Case No.:107/13/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00735/AM17/ RLA File :03/94/040/00540/AM17/ Lic.No/Date:0310807829 16.09.2016 Defer Date: 12.04.2017 376

Case No.:46/13/82-ALC4/2016 Party Name:GOPINATH

CHEM-TECH LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00674/AM17/ RLA File :08/24/040/00215/AM17/ Lic.No/Date:0810138683 16.09.2016 Defer Date: 12.04.2017 Decision :Deferred. 377

Case No.:211/17/82-

ALC4/2016 Party Name:DIVIS PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred

62 HQ File :01/82/050/01172/AM17/ RLA File :09/24/040/00270/AM17/ Lic.No/Date:0910064148 19.09.2016 Defer Date: 12.04.2017 378

Case No.:103/13/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00731/AM17/ RLA File :03/94/040/00516/AM17/ Lic.No/Date:0310807914 20.09.2016 Defer Date: 12.04.2017 379

Case No.:43/13/82-ALC4/2016 Party Name:AUROBINDO

PHARMA LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00671/AM17/ RLA File :09/24/040/00303/AM17/ Lic.No/Date:0910064168 21.09.2016 Defer Date: 12.04.2017 380

Case No.:119/13/82-

ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00747/AM17/ RLA File :07/24/040/00207/AM17/ Lic.No/Date:0710110442 21.09.2016 Defer Date: 12.04.2017 Decision :Deferred. 381

Case No.:45/13/82-ALC4/2016 Party Name:BIO TECH

OPHTHALMICS PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00673/AM17/ RLA File :08/24/040/00216/AM17/ Lic.No/Date:0810138715 22.09.2016 Defer Date: 12.04.2017 382

Case No.:91/13/82-ALC4/2016 Party Name:CADILA

HEALTHCARE LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00719/AM17/ RLA File :08/24/040/00242/AM17/ Lic.No/Date:0810138723 22.09.2016 Defer Date: 12.04.2017 383

Case No.:100/13/82-

ALC4/2016 Party Name:K V AROCHEM PVT. LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00728/AM17/ RLA File :03/94/040/00525/AM17/ Lic.No/Date:0310807975 22.09.2016 Defer Date: 12.04.2017 Decision :Deferred. 384 Case No.:192/17/82- Party Name:SATYA Meet No/Date:19/82- Status:

63 ALC4/2016 DEEPTHA PHARMACEUTICALS LTD ALC4/2016 08.03.2017 Deferred HQ File :01/82/050/01153/AM17/ RLA File :09/24/040/00332/AM17/ Lic.No/Date:0910064172 22.09.2016 Defer Date: 12.04.2017 385

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

SPECIALTY MATERIALS (INDIA) PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00710/AM17/ RLA File :52/24/040/00040/AM17/ Lic.No/Date:5210042029 22.09.2016 Defer Date: 12.04.2017 386

Case No.:4/17/82-ALC4/2016

Party Name:MANGALAM DRUGS & ORGANICS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00965/AM17/ RLA File :03/95/040/00322/AM17/ Lic.No/Date:0310808020 23.09.2016 Defer Date: 12.04.2017 387

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

& PHARMACEUTICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01017/AM17/ RLA File :03/94/040/00582/AM17/ Lic.No/Date:0310808049 26.09.2016 Defer Date: 12.04.2017 388

Case No.:102/17/82-

ALC4/2016 Party Name:PAB ORGANICS PVT.LTD, Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01063/AM17/ RLA File :34/24/040/00180/AM17/ Lic.No/Date:3410042558 26.09.2016 Defer Date: 12.04.2017 Decision :Deferred. 389

Case No.:193/17/82-

ALC4/2016 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01154/AM17/ RLA File :09/24/040/00345/AM17/ Lic.No/Date:0910064185 26.09.2016 Defer Date: 12.04.2017 Decision :Deferred. 390

Case No.:195/17/82-

ALC4/2016 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01156/AM17/ RLA File :09/24/040/00344/AM17/ Lic.No/Date:0910064184 26.09.2016 Defer Date: 12.04.2017 Decision :Deferred.

64 391

Case No.:55/17/82-ALC4/2016 Party Name:AMINES &

Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01016/AM17/ RLA File :03/94/040/00570/AM17/ Lic.No/Date:0310808091 27.09.2016 Defer Date: 12.04.2017 Decision :Deferred. 392

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

ORGANICS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00974/AM17/ RLA File :03/94/040/00585/AM17/ Lic.No/Date:0310808096 27.09.2016 Defer Date: 12.04.2017 Decision :Deferred. 393

Case No.:113/13/82-

ALC4/2016 LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00741/AM17/ RLA File :09/24/040/00342/AM17/ Lic.No/Date:0910064191 27.09.2016 Defer Date: 12.04.2017 394

Case No.:114/13/82-

ALC4/2016 LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00742/AM17/ RLA File :09/24/040/00341/AM17/ Lic.No/Date:0910064192 27.09.2016 Defer Date: 12.04.2017 395

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

PVT. LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01015/AM17/ RLA File :03/94/040/00524/AM17/ Lic.No/Date:0310808098 27.09.2016 Defer Date: 12.04.2017 Decision :Deferred. 396

Case No.:139/13/82-

ALC4/2016 Party Name:VISWAAT CHEMICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00767/AM17/ RLA File :03/95/040/00302/AM17/ Lic.No/Date:0310808110 27.09.2016 Defer Date: 12.04.2017 Decision :Deferred. 397

Case No.:58/17/82-ALC4/2016 Party Name:HUBERGROUP

INDIA PRIVATE LIMITED. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01019/AM17/ RLA File :03/94/040/00583/AM17/ Lic.No/Date:0310808142 28.09.2016 Defer Date:

65 decision taken by NC in it meeting No.20/82 dated 20.09.2012, uploaded at the end of 398

Case No.:99/13/82-ALC4/2016 Party Name:ATUL LIMITED,

Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00727/AM17/ RLA File :08/24/040/00214/AM17/ Lic.No/Date:0810138766 29.09.2016 Defer Date: 12.04.2017 Decision :Deferred. 399

Case No.:194/17/82-

ALC4/2016 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01155/AM17/ RLA File :09/24/040/00339/AM17/ Lic.No/Date:0910064206 29.09.2016 Defer Date: 12.04.2017 400

Case No.:12/17/82-ALC4/2016 Party Name:ALIVIRA

ANIMAL HEALTH LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00973/AM17/ RLA File :03/94/040/00557/AM17/ Lic.No/Date:0310808216 30.09.2016 Defer Date: 12.04.2017 401

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

PVT LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00718/AM17/ RLA File :52/24/040/00042/AM17/ Lic.No/Date:5210042032 30.09.2016 Defer Date: 12.04.2017 Decision :Deferred. 402

Case No.:125/13/82-

ALC4/2016 Party Name:SURVIVAL Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00753/AM17/ RLA File :03/95/040/00490/AM17/ Lic.No/Date:0310808208 30.09.2016 Defer Date: 12.04.2017 Decision :Deferred. 403

Case No.:126/13/82-

ALC4/2016 Party Name:SURVIVAL Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00754/AM17/ RLA File :03/95/040/00410/AM17/ Lic.No/Date:0310808209 30.09.2016 Defer Date: 12.04.2017 Decision :Deferred.

66 404

Case No.:63/17/82-ALC4/2016 Party Name:AARTI

INDUSTRIES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01024/AM17/ RLA File :03/94/040/00559/AM17/ Lic.No/Date:0310808233 03.10.2016 Defer Date: 12.04.2017 405

Case No.:182/17/82-

ALC4/2016 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01143/AM17/ RLA File :09/24/040/00305/AM17/ Lic.No/Date:0910064230 05.10.2016 Defer Date: 12.04.2017 406

Case No.:204/17/82-

ALC4/2016 Party Name:NAGARJUNA AGRICHEM LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01165/AM17/ RLA File :09/24/040/00313/AM17/ Lic.No/Date:0910064232 05.10.2016 Defer Date: 12.04.2017 Decision :Deferred. 407

Case No.:29/17/82-ALC4/2016 Party Name:PALADIN

PAINTS AND CHEMICALS PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00990/AM17/ RLA File :03/95/040/00514/AM17/ Lic.No/Date:0310808276 05.10.2016 Defer Date: 12.04.2017 Decision :Deferred. 408

Case No.:200/17/82-

ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01161/AM17/ RLA File :09/24/040/00312/AM17/ Lic.No/Date:0910064252 06.10.2016 Defer Date: 12.04.2017 409

Case No.:11/17/82-ALC4/2016 Party Name:CIPLA LIMITED.

Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00972/AM17/ RLA File :03/94/040/00617/AM17/ Lic.No/Date:0310808312 06.10.2016 Defer Date: 12.04.2017 410

Case No.:75/17/82-ALC4/2016 Party Name:MAHAVIR

SYNTHESIS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01036/AM17/ RLA File :52/24/040/00043/AM17/ Lic.No/Date:5210042038 06.10.2016 Defer Date: 12.04.2017 Decision :Deferred.

67 411

Case No.:205/17/82-

ALC4/2016 Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01166/AM17/ RLA File :09/24/040/00375/AM17/ Lic.No/Date:0910064235 06.10.2016 Defer Date: 12.04.2017 412

Case No.:30/17/82-ALC4/2016 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00991/AM17/ RLA File :03/95/040/00532/AM17/ Lic.No/Date:0310808294 06.10.2016 Defer Date: decision taken by NC in it meeting No.05/82 dated 04.05.2010, uploaded at the end of 413

Case No.:10/17/82-ALC4/2016 Party Name:FDC LTD

Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00971/AM17/ RLA File :03/94/040/00614/AM17/ Lic.No/Date:0310808345 07.10.2016 Defer Date: 12.04.2017 414

Case No.:33/17/82-ALC4/2016 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00994/AM17/ RLA File :03/95/040/00546/AM17/ Lic.No/Date:0310808376 13.10.2016 Defer Date: 12.04.2017 Decision :Deferred. 415

Case No.:69/17/82-ALC4/2016 Party Name:PORUS

LABORATORIES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01030/AM17/ RLA File :09/24/040/00374/AM17/ Lic.No/Date:0910064265 14.10.2016 Defer Date: 12.04.2017 Decision :Deferred. 416

Case No.:201/17/82-

ALC4/2016 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01162/AM17/ RLA File :09/24/040/00354/AM17/ Lic.No/Date:0910064264 14.10.2016 Defer Date: 12.04.2017 Decision :Deferred. 417 Case No.:49/17/82-ALC4/2016 Party Name:CIPLA LIMITED. Meet No/Date:19/82- ALC4/2016 Status: Deferred

68 08.03.2017 HQ File :01/82/050/01010/AM17/ RLA File :03/94/040/00622/AM17/ Lic.No/Date:0310808433 17.10.2016 Defer Date: 12.04.2017 418

Case No.:9/17/82-ALC4/2016

Party Name:CLARIANT INDIA LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00970/AM17/ RLA File :03/94/040/00629/AM17/ Lic.No/Date:0310808422 17.10.2016 Defer Date: 12.04.2017 419

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

LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01000/AM17/ RLA File :03/95/040/00324/AM17/ Lic.No/Date:0310808410 17.10.2016 Defer Date: 12.04.2017 Decision :Deferred. 420

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

PHARMACEUTICALS Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00992/AM17/ RLA File :03/95/040/00540/AM17/ Lic.No/Date:0310808412 17.10.2016 Defer Date: 12.04.2017 421

Case No.:25/17/82-ALC4/2016 Party Name:CLARIANT

INDIA LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00986/AM17/ RLA File :03/94/040/00648/AM17/ Lic.No/Date:0310808508 18.10.2016 Defer Date: 12.04.2017 422

Case No.:64/17/82-ALC4/2016 Party Name:RELIANCE

INDUSTRIES LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01025/AM17/ RLA File :03/95/040/00457/AM17/ Lic.No/Date:0310808513 18.10.2016 Defer Date: decision taken by NC in it meeting No.14/82 dated 31.07.2012, uploaded at the end of 423

Case No.:32/17/82-ALC4/2016 Party Name:UNIMAX

LABORATORIES PVT.LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00993/AM17/ RLA File :03/95/040/00551/AM17/ Lic.No/Date:0310808488 18.10.2016 Defer Date: 12.04.2017

69 424

Case No.:50/17/82-ALC4/2016 Party Name:AIMS IMPEX

PVT. LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01011/AM17/ RLA File :03/94/040/00639/AM17/ Lic.No/Date:0310808566 20.10.2016 Defer Date: 12.04.2017 425

Case No.:214/17/82-

ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01175/AM17/ RLA File :31/83/040/00071/AM17/ Lic.No/Date:3110066376 20.10.2016 Defer Date: 12.04.2017 Decision :Deferred. 426

Case No.:47/17/82-ALC4/2016 Party Name:GLENMARK

PHARMACEUTICALS LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01008/AM17/ RLA File :03/94/040/00661/AM17/ Lic.No/Date:0310808581 20.10.2016 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/30/2014- PI(Norms) dated Oct. 2014, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 427

Case No.:34/17/82-ALC4/2016 Party Name:VHB

MEDISCIENCES LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00995/AM17/ RLA File :03/95/040/00462/AM17/ Lic.No/Date:0310808576 20.10.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION A-3676. RA concerned may take further necessary action as per the decision of NC. 428

Case No.:57/17/82-ALC4/2016 Party Name:G AMPHRAY

LABORATORIES, Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01018/AM17/ RLA File :03/94/040/00526/AM17/ Lic.No/Date:0310808624 21.10.2016 Defer Date: 12.04.2017 429

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

INTERNATIONAL Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01037/AM17/ RLA File :52/24/040/00046/AM17/ Lic.No/Date:5210042057 25.10.2016 Defer Date: 12.04.2017

70 Decision :Deferred. 430

Case No.:94/17/82-ALC4/2016 Party Name:SHIVA

PHARMACHEM LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01055/AM17/ RLA File :34/24/040/00204/AM17/ Lic.No/Date:3410042618 25.10.2016 Defer Date: 12.04.2017 Decision :Deferred. 431

Case No.:24/17/82-ALC4/2016 Party Name:SUNSHIELD

CHEMICALS LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00985/AM17/ RLA File :03/95/040/00582/AM17/ Lic.No/Date:0310808689 25.10.2016 Defer Date: 12.04.2017 Decision :Deferred. 432

Case No.:35/17/82-ALC4/2016 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00996/AM17/ RLA File :03/95/040/00594/AM17/ Lic.No/Date:0310808711 25.10.2016 Defer Date: decision taken by NC in it meeting No.22/82 dated 20.02.2014, uploaded at the end of 433

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

LIFESCIENCE PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00976/AM17/ RLA File :03/94/040/00672/AM17/ Lic.No/Date:0310808773 26.10.2016 Defer Date: 12.04.2017 434

Case No.:20/17/82-ALC4/2016 Party Name:BLUE CIRCLE

ORGANICS PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00981/AM17/ RLA File :03/94/040/00606/AM17/ Lic.No/Date:0310808832 27.10.2016 Defer Date: 12.04.2017 Decision :Deferred. 435

Case No.:21/17/82-ALC4/2016 Party Name:BLUE CIRCLE

ORGANICS PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00982/AM17/ RLA File :03/94/040/00548/AM17/ Lic.No/Date:0310808830 27.10.2016 Defer Date: 12.04.2017 Decision :Deferred.

71 436

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

BIOTECH LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01056/AM17/ RLA File :08/24/040/00268/AM17/ Lic.No/Date:0810138997 28.10.2016 Defer Date: 12.04.2017 437

Case No.:52/17/82-ALC4/2016 Party Name:GLENMARK

PHARMACEUTICALS LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01013/AM17/ RLA File :03/94/040/00658/AM17/ Lic.No/Date:0310808927 02.11.2016 Defer Date: 12.04.2017 438

Case No.:40/17/82-ALC4/2016 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01001/AM17/ RLA File :03/95/040/00616/AM17/ Lic.No/Date:0310808975 04.11.2016 Defer Date: decision taken by NC in it meeting No.22/82 dated 20.02.2014, uploaded at the end of 439

Case No.:59/17/82-ALC4/2016 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: approved HQ File :01/82/050/01020/AM17/ RLA File :03/95/040/00617/AM17/ Lic.No/Date:0310808973 04.11.2016 Defer Date: decision taken by NC in it meeting No.22/82 dated 20.02.2014, uploaded at the end of 440

Case No.:27/17/82-ALC4/2016 Party Name:SHREE LIFE

SCIENCES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/00988/AM17/ RLA File :03/95/040/00621/AM17/ Lic.No/Date:0310809008 07.11.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION A-206 for above 10ml. RA concerned may take further necessary action as per the decision of NC. 441

Case No.:14/17/82-ALC4/2016 Party Name:GLENMARK

PHARMACEUTICALS LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00975/AM17/ RLA File :03/94/040/00717/AM17/ Lic.No/Date:0310809031 08.11.2016 Defer Date: 12.04.2017

72 442

Case No.:18/17/82-ALC4/2016 Party Name:J.B. CHEMICALS

& PHARMACEUTICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00979/AM17/ RLA File :03/94/040/00718/AM17/ Lic.No/Date:0310809038 08.11.2016 Defer Date: 12.04.2017 443

Case No.:43/17/82-ALC4/2016 Party Name:J.B. CHEMICALS

& PHARMACEUTICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01004/AM17/ RLA File :03/94/040/00703/AM17/ Lic.No/Date:0310809039 08.11.2016 Defer Date: 12.04.2017 444

Case No.:22/17/82-ALC4/2016 Party Name:J.B. CHEMICALS

& PHARMACEUTICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00983/AM17/ RLA File :03/94/040/00726/AM17/ Lic.No/Date:0310809070 09.11.2016 Defer Date: 12.04.2017 445

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

PHARMACHEM LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01049/AM17/ RLA File :34/24/040/00220/AM17/ Lic.No/Date:3410042652 09.11.2016 Defer Date: 12.04.2017 Decision :Deferred. 446

Case No.:26/17/82-ALC4/2016 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00987/AM17/ RLA File :03/95/040/00348/AM17/ Lic.No/Date:0310809069 09.11.2016 Defer Date: 12.04.2017 Decision :Deferred. 447

Case No.:37/17/82-ALC4/2016 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00998/AM17/ RLA File :03/95/040/00344/AM17/ Lic.No/Date:0310809065 09.11.2016 Defer Date: 12.04.2017 Decision :Deferred. 448

Case No.:38/17/82-ALC4/2016 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: approved HQ File :01/82/050/00999/AM17/ RLA File :03/95/040/00630/AM17/ Lic.No/Date:0310809075 09.11.2016 Defer Date:

73 decision taken by NC in it meeting No.22/82 dated 20.02.2014, uploaded at the end of 449

Case No.:17/17/82-ALC4/2016 Party Name:J.B. CHEMICALS

& PHARMACEUTICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00978/AM17/ RLA File :03/94/040/00730/AM17/ Lic.No/Date:0310809095 10.11.2016 Defer Date: 12.04.2017 450

Case No.:45/17/82-ALC4/2016 Party Name:KRISHNA

ANTIOXIDANTS PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01006/AM17/ RLA File :03/94/040/00704/AM17/ Lic.No/Date:0310809094 10.11.2016 Defer Date: 12.04.2017 Decision :Deferred. 451

Case No.:2/15/82-ALC4/2016

Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00816/AM17/ RLA File :03/95/040/00449/AM17/ Lic.No/Date:0310809088 10.11.2016 Defer Date: 12.04.2017 Decision :Deferred. 452

Case No.:41/17/82-ALC4/2016 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01002/AM17/ RLA File :03/95/040/00515/AM17/ Lic.No/Date:0310809091 10.11.2016 Defer Date: 12.04.2017 Decision :Deferred. 453

Case No.:103/17/82-

ALC4/2016 Party Name:FRESENIUS Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01064/AM17/ RLA File :05/23/040/00370/AM17/ Lic.No/Date:0510400406 11.11.2016 Defer Date: 12.04.2017 454

Case No.:19/17/82-ALC4/2016 Party Name:HIKAL LIMITED

Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00980/AM17/ RLA File :03/94/040/00687/AM17/ Lic.No/Date:0310809149 11.11.2016 Defer Date: 12.04.2017 Decision :Deferred.

74 455

Case No.:101/17/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01062/AM17/ RLA File :05/23/040/00372/AM17/ Lic.No/Date:0510400404 11.11.2016 Defer Date: 12.04.2017 Decision :Deferred. 456

Case No.:130/17/82-

ALC4/2016 Party Name:BAYER VAPI PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01091/AM17/ RLA File :03/94/040/00735/AM17/ Lic.No/Date:0310809204 22.11.2016 Defer Date: 12.04.2017 Decision :Deferred. 457

Case No.:138/17/82-

ALC4/2016 Party Name:MAPLE CROSS REMEDIES PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01099/AM17/ RLA File :03/95/040/00624/AM17/ Lic.No/Date:0310809210 22.11.2016 Defer Date: 12.04.2017 Decision :Deferred. 458

Case No.:66/17/82-ALC4/2016 Party Name:MEGHMANI

INDUSTRIES LTD, Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01027/AM17/ RLA File :08/24/040/00293/AM17/ Lic.No/Date:0810139050 22.11.2016 Defer Date: 12.04.2017 Decision :Deferred. 459

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

CHEMICALS Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01052/AM17/ RLA File :34/24/040/00224/AM17/ Lic.No/Date:3410042673 22.11.2016 Defer Date: 12.04.2017 Decision :Deferred. 460

Case No.:124/17/82-

ALC4/2016 Party Name:SURVIVAL Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01085/AM17/ RLA File :03/95/040/00639/AM17/ Lic.No/Date:0310809216 22.11.2016 Defer Date: 12.04.2017 Decision :Deferred. 461

Case No.:120/17/82-

ALC4/2016 Party Name:ZIM LABORATORIES LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01081/AM17/ RLA File :03/95/040/00602/AM17/ Lic.No/Date:0310809205 22.11.2016 Defer Date: 12.04.2017

75 462

Case No.:141/17/82-

ALC4/2016 Party Name:MELOG SPECIALITY CHEMICALS PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01102/AM17/ RLA File :03/95/040/00610/AM17/ Lic.No/Date:0310809264 23.11.2016 Defer Date: 12.04.2017 Decision :Deferred. 463

Case No.:98/17/82-ALC4/2016 Party Name:NECTAR

LIFESCIENCES LIMITED, Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01059/AM17/ RLA File :22/24/040/00071/AM17/ Lic.No/Date:2210015595 23.11.2016 Defer Date: 12.04.2017 464

Case No.:99/17/82-ALC4/2016 Party Name:SAURAV

CHEMICALS LTD, Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01060/AM17/ RLA File :22/24/040/00073/AM17/ Lic.No/Date:2210015598 23.11.2016 Defer Date: 12.04.2017 465

Case No.:1/17/82-ALC4/2016

Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/00962/AM17/ RLA File :03/95/040/00640/AM17/ Lic.No/Date:0310809268 23.11.2016 Defer Date: 12.04.2017 Decision :Deferred. 466

Case No.:87/17/82-ALC4/2016 Party Name:ASIATIC DRUGS

&PHARMACEUTICALS PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01048/AM17/ RLA File :05/23/040/00365/AM17/ Lic.No/Date:0510400453 24.11.2016 Defer Date: 12.04.2017 467

Case No.:86/17/82-ALC4/2016 Party Name:ALCHEM

INTERNATIONAL PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01047/AM17/ RLA File :05/23/040/00358/AM17/ Lic.No/Date:0510400474 25.11.2016 Defer Date: 12.04.2017 468

Case No.:155/17/82-

ALC4/2016 Party Name:CIPLA LIMITED. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01116/AM17/ RLA File :03/94/040/00757/AM17/ Lic.No/Date:0310809323 25.11.2016 Defer Date: 12.04.2017

76 469

Case No.:162/17/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01123/AM17/ RLA File :03/94/040/00678/AM17/ Lic.No/Date:0310809339 28.11.2016 Defer Date: NC in its meeting No.08/82 dated 24.05.2011, uploaded at the end of these minutes or 470

Case No.:168/17/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01129/AM17/ RLA File :03/94/040/00707/AM17/ Lic.No/Date:0310809340 28.11.2016 Defer Date: NC in its meeting No.25/82 dated 29.11.2012, uploaded at the end of these minutes or 471

Case No.:169/17/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01130/AM17/ RLA File :03/94/040/00709/AM17/ Lic.No/Date:0310809344 28.11.2016 Defer Date: NC in its meeting No.03/82 dated 08.05.2014, uploaded at the end of these minutes or 472

Case No.:170/17/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01131/AM17/ RLA File :03/94/040/00708/AM17/ Lic.No/Date:0310809341 28.11.2016 Defer Date: NC in its meeting No.13/82 dated 19.12.2014, uploaded at the end of these minutes or 473

Case No.:171/17/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01132/AM17/ RLA File :03/94/040/00732/AM17/ Lic.No/Date:0310809343 28.11.2016 Defer Date: NC in its meeting No.01/82 dated 10.04.2014, uploaded at the end of these minutes or

77 474

Case No.:172/17/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01133/AM17/ RLA File :03/94/040/00710/AM17/ Lic.No/Date:0310809345 28.11.2016 Defer Date: NC in its meeting No.13/82 dated 19.12.2014, uploaded at the end of these minutes or 475

Case No.:179/17/82-

ALC4/2016 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01140/AM17/ RLA File :03/94/040/00744/AM17/ Lic.No/Date:0310809373 28.11.2016 Defer Date: 12.04.2017 Decision :Deferred. 476

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

PHARMACEUTICALS LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01050/AM17/ RLA File :08/24/040/00319/AM17/ Lic.No/Date:0810139094 28.11.2016 Defer Date: 12.04.2017 477

Case No.:129/17/82-

ALC4/2016 Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01090/AM17/ RLA File :03/94/040/00675/AM17/ Lic.No/Date:0310809367 28.11.2016 Defer Date: 12.04.2017 Decision :Deferred. 478

Case No.:180/17/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01141/AM17/ RLA File :03/94/040/00689/AM17/ Lic.No/Date:0310809370 28.11.2016 Defer Date: 12.04.2017 479

Case No.:84/17/82-ALC4/2016 Party Name:MOREPEN

LABORATORIES LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01045/AM17/ RLA File :05/24/040/00415/AM17/ Lic.No/Date:0510400507 28.11.2016 Defer Date: 12.04.2017

78 480

Case No.:163/17/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01124/AM17/ RLA File :03/94/040/00734/AM17/ Lic.No/Date:0310809399 29.11.2016 Defer Date: 12.04.2017 Decision :Deferred. 481

Case No.:164/17/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01125/AM17/ RLA File :03/94/040/00733/AM17/ Lic.No/Date:0310809398 29.11.2016 Defer Date: 12.04.2017 Decision :Deferred. 482

Case No.:165/17/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01126/AM17/ RLA File :03/94/040/00731/AM17/ Lic.No/Date:0310809396 29.11.2016 Defer Date: 12.04.2017 Decision :Deferred. 483

Case No.:106/17/82-

ALC4/2016 Party Name:PI INDUSTRIES LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01067/AM17/ RLA File :13/24/040/00033/AM17/ Lic.No/Date:1310048462 29.11.2016 Defer Date: 12.04.2017 Decision :Deferred. 484

Case No.:118/17/82-

ALC4/2016 Party Name:SUPREET CHEMICALS PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01079/AM17/ RLA File :52/24/040/00050/AM17/ Lic.No/Date:5210042073 29.11.2016 Defer Date: 12.04.2017 Decision :Deferred. 485

Case No.:139/17/82-

ALC4/2016 Party Name:ZIM LABORATORIES LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01100/AM17/ RLA File :03/95/040/00684/AM17/ Lic.No/Date:0310809406 29.11.2016 Defer Date: 12.04.2017 486

Case No.:151/17/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01112/AM17/ RLA File :03/95/040/00676/AM17/ Lic.No/Date:0310809433 30.11.2016 Defer Date: 12.04.2017 Decision :Deferred.

79 487

Case No.:85/17/82-ALC4/2016 Party Name:SENTISS

PHARMA PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01046/AM17/ RLA File :05/24/040/00416/AM17/ Lic.No/Date:0510400570 01.12.2016 Defer Date: 12.04.2017 488

Case No.:116/17/82-

ALC4/2016 Party Name:AETHER INDUSTRIES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01077/AM17/ RLA File :52/24/040/00053/AM17/ Lic.No/Date:5210042078 02.12.2016 Defer Date: 12.04.2017 Decision :Deferred. 489

Case No.:133/17/82-

ALC4/2016 Party Name:AMINES & Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01094/AM17/ RLA File :03/94/040/00771/AM17/ Lic.No/Date:0310809551 02.12.2016 Defer Date: 12.04.2017 490

Case No.:132/17/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01093/AM17/ RLA File :03/94/040/00775/AM17/ Lic.No/Date:0310809552 02.12.2016 Defer Date: 12.04.2017 491

Case No.:97/17/82-ALC4/2016 Party Name:CADILA

HEALTHCARE LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01058/AM17/ RLA File :08/24/040/00324/AM17/ Lic.No/Date:0810139218 05.12.2016 Defer Date: 12.04.2017 492

Case No.:181/17/82-

ALC4/2016 Party Name:CENTAUR PHARMACEUTICALS PVT. LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01142/AM17/ RLA File :03/94/040/00537/AM17/ Lic.No/Date:0310809606 05.12.2016 Defer Date: 12.04.2017 493

Case No.:131/17/82-

ALC4/2016 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01092/AM17/ RLA File :03/94/040/00794/AM17/ Lic.No/Date:0310809604 05.12.2016 Defer Date: 12.04.2017

80 Decision :Deferred. 494

Case No.:128/17/82-

ALC4/2016 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01089/AM17/ RLA File :03/94/040/00801/AM17/ Lic.No/Date:0310809609 05.12.2016 Defer Date: 12.04.2017 495

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

CHEM-TECH LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01043/AM17/ RLA File :08/24/040/00318/AM17/ Lic.No/Date:0810139204 05.12.2016 Defer Date: 12.04.2017 496

Case No.:96/17/82-ALC4/2016 Party Name:CADILA

HEALTHCARE LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01057/AM17/ RLA File :08/24/040/00326/AM17/ Lic.No/Date:0810139221 06.12.2016 Defer Date: 12.04.2017 497

Case No.:78/17/82-ALC4/2016 Party Name:INDIA GLYCOLS

LTD., Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01039/AM17/ RLA File :05/23/040/00412/AM17/ Lic.No/Date:0510400608 06.12.2016 Defer Date: 12.04.2017 498

Case No.:135/17/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01096/AM17/ RLA File :03/95/040/00697/AM17/ Lic.No/Date:0310809629 06.12.2016 Defer Date: 12.04.2017 Decision :Deferred. 499

Case No.:167/17/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01128/AM17/ RLA File :03/95/040/00696/AM17/ Lic.No/Date:0310809628 06.12.2016 Defer Date: NC in its meeting No.22/82 dated 20.02.2014, uploaded at the end of these minutes or

81 500

Case No.:79/17/82-ALC4/2016 Party Name:ABEERS

PHARMACEUTICALS PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01040/AM17/ RLA File :05/23/040/00426/AM17/ Lic.No/Date:0510400659 07.12.2016 Defer Date: 12.04.2017 501

Case No.:80/17/82-ALC4/2016 Party Name:ABEERS

PHARMACEUTICALS PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01041/AM17/ RLA File :05/23/040/00424/AM17/ Lic.No/Date:0510400658 07.12.2016 Defer Date: 12.04.2017 502

Case No.:83/17/82-ALC4/2016 Party Name:INDO PHYTO

CHEMICALS PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01044/AM17/ RLA File :05/23/040/00361/AM17/ Lic.No/Date:0510400646 07.12.2016 Defer Date: 12.04.2017 503

Case No.:174/17/82-

ALC4/2016 Party Name:INDOCO REMEDIES LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01135/AM17/ RLA File :03/94/040/00769/AM17/ Lic.No/Date:0310809668 07.12.2016 Defer Date: Decision: The Committee based on the earlier recommendation of Department of Pharmaceutical forwarded vide O.M.No.35011/353/2015-PI(Norms) dated 17.11.2015, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per decision of NC. 504

Case No.:126/17/82-

ALC4/2016 Party Name:AMINES & Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01087/AM17/ RLA File :03/94/040/00803/AM17/ Lic.No/Date:0310809672 08.12.2016 Defer Date: 12.04.2017 Decision :Deferred. 505

Case No.:127/17/82-

ALC4/2016 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01088/AM17/ RLA File :03/94/040/00800/AM17/ Lic.No/Date:0310809684 08.12.2016 Defer Date: 12.04.2017 Decision :Deferred. 506 Case No.:81/17/82-ALC4/2016 Party Name:BIO TECH OPHTHALMICS PVT LTD Meet No/Date:19/82- ALC4/2016 Status: Deferred

82 08.03.2017 HQ File :01/82/050/01042/AM17/ RLA File :08/24/040/00360/AM17/ Lic.No/Date:0810139254 09.12.2016 Defer Date: 12.04.2017 507

Case No.:187/17/82-

ALC4/2016 Party Name:SRINI PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01148/AM17/ RLA File :09/24/040/00483/AM17/ Lic.No/Date:0910064463 09.12.2016 Defer Date: 12.04.2017 508

Case No.:148/17/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01109/AM17/ RLA File :03/95/040/00703/AM17/ Lic.No/Date:0310809708 09.12.2016 Defer Date: 12.04.2017 509

Case No.:158/17/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01119/AM17/ RLA File :03/95/040/00690/AM17/ Lic.No/Date:0310809727 09.12.2016 Defer Date: 12.04.2017 Decision :Deferred. 510

Case No.:159/17/82-

ALC4/2016 Party Name:UNIMAX LABORATORIES PVT.LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01120/AM17/ RLA File :03/95/040/00669/AM17/ Lic.No/Date:0310809709 09.12.2016 Defer Date: 12.04.2017 511

Case No.:107/17/82-

ALC4/2016 Party Name:AMANTA HEALTHCARE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01068/AM17/ RLA File :08/24/040/00361/AM17/ Lic.No/Date:0810139255 13.12.2016 Defer Date: 12.04.2017 512

Case No.:178/17/82-

ALC4/2016 Party Name:AMINES & Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01139/AM17/ RLA File :03/94/040/00804/AM17/ Lic.No/Date:0310809744 13.12.2016 Defer Date: 12.04.2017 Decision :Deferred.

83 513

Case No.:146/17/82-

ALC4/2016 Party Name:CIPLA LIMITED. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01107/AM17/ RLA File :03/94/040/00835/AM17/ Lic.No/Date:0310809781 13.12.2016 Defer Date: 12.04.2017 514

Case No.:173/17/82-

ALC4/2016 Party Name:HARMONY LIFESCIENCE PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01134/AM17/ RLA File :03/94/040/00815/AM17/ Lic.No/Date:0310809753 13.12.2016 Defer Date: 12.04.2017 515

Case No.:142/17/82-

ALC4/2016 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01103/AM17/ RLA File :03/94/040/00818/AM17/ Lic.No/Date:0310809757 13.12.2016 Defer Date: 12.04.2017 Decision :Deferred. 516

Case No.:143/17/82-

ALC4/2016 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01104/AM17/ RLA File :03/94/040/00819/AM17/ Lic.No/Date:0310809758 13.12.2016 Defer Date: 12.04.2017 Decision :Deferred. 517

Case No.:160/17/82-

ALC4/2016 Party Name:SIRMAXO CHEMICALS PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01121/AM17/ RLA File :03/95/040/00492/AM17/ Lic.No/Date:0310809770 13.12.2016 Defer Date: 12.04.2017 518

Case No.:156/17/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01117/AM17/ RLA File :03/95/040/00718/AM17/ Lic.No/Date:0310809765 13.12.2016 Defer Date: NC in its meeting No.07/82 dated 18.05.2010, uploaded at the end of these minutes or 519

Case No.:157/17/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved

84 HQ File :01/82/050/01118/AM17/ RLA File :03/95/040/00719/AM17/ Lic.No/Date:0310809768 13.12.2016 Defer Date: NC in its meeting No.07/82 dated 18.05.2010, uploaded at the end of these minutes or 520

Case No.:153/17/82-

ALC4/2016 Party Name:PALADIN PAINTS AND CHEMICALS PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01114/AM17/ RLA File :03/95/040/00699/AM17/ Lic.No/Date:0310809824 14.12.2016 Defer Date: 12.04.2017 521

Case No.:147/17/82-

ALC4/2016 Party Name:S M CHEMICAL VAPI PRIVATE LIMITED Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01108/AM17/ RLA File :03/95/040/00659/AM17/ Lic.No/Date:0310809834 14.12.2016 Defer Date: 12.04.2017 Decision :Deferred. 522

Case No.:213/17/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01174/AM17/ RLA File :08/24/040/00321/AM17/ Lic.No/Date:0810139295 15.12.2016 Defer Date: 12.04.2017 Decision :Deferred for want of comments from DoP. 523

Case No.:177/17/82-

ALC4/2016 Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01138/AM17/ RLA File :03/94/040/00845/AM17/ Lic.No/Date:0310809853 15.12.2016 Defer Date: 12.04.2017 524

Case No.:176/17/82-

ALC4/2016 Party Name:GITANJALI CHEMICALS PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01137/AM17/ RLA File :03/94/040/00741/AM17/ Lic.No/Date:0310809851 15.12.2016 Defer Date: 12.04.2017 525

Case No.:149/17/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01110/AM17/ RLA File :03/95/040/00721/AM17/ Lic.No/Date:0310809874 15.12.2016 Defer Date: 12.04.2017

85 526

Case No.:150/17/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01111/AM17/ RLA File :03/95/040/00722/AM17/ Lic.No/Date:0310809877 15.12.2016 Defer Date: 12.04.2017 527

Case No.:152/17/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Deferred HQ File :01/82/050/01113/AM17/ RLA File :03/95/040/00724/AM17/ Lic.No/Date:0310809913 15.12.2016 Defer Date: 12.04.2017 Decision :Deferred. 528

Case No.:154/17/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:19/82- ALC4/2016 08.03.2017 Status: Approved HQ File :01/82/050/01115/AM17/ RLA File :03/95/040/00748/AM17/ Lic.No/Date:0310810059 22.12.2016 Defer Date: NC in its meeting No.18/82 dated 19.12.2013, uploaded at the end of these minutes or Manual Agenda of NC Meeting No. 19/82/2016 Scheduled to be held on 08.03.2017

Case No. B- 01

M.No.19/AM-17 Date 08.03.2017 M/s. Salvi Chemical Industries Ltd File No. 01/82/171/0403/AM 17 RLA No.03/95/040/0209/AM 11 Adv.Auth. No. 0310581659 dated. 01.07.2010 Decision: The Committee considered this case for ratification of ad-hoc norms under Para 4.07 of HBP as per agenda. The Committee based on the earlier decision taken by NC in its meeting No. 22/AM12 dated 30.08.2011 Case No.B-244, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per decision of NC.

Case No. B- 02

M.No.19/AM-17 Date 08.03.2017 M/s. Shasun Pharmaceuticals Ltd File No. 01/82/050/00387/AM 14 RLA No.04/24/040/00065/AM 14 Adv.Auth. No. 041047559 dated. 27.06.2013 Decision: The Committee reconsidered this case for fixation of adhoc norms as per agenda. The Committee decided to defer this case for comments from D/o Pharmaceuticals.

86

Case No. B- 03

M.No.19/AM-17 Date 08.03.2017 M/s. Shasun Pharmaceuticals Ltd File No. 01/82/050/01124/AM 14 RLA No.04/24/040/01183/AM 14 Adv.Auth. No. 0410152258 dated. 27.11.2013 Decision: The Committee reconsidered this case for fixation of adhoc norms as per agenda. The Committee decided to defer this case for comments from D/o Pharmaceuticals.

Case No. B- 04

M.No.19/AM-17 Date 08.03.2017 M/s. Shasun Pharmaceuticals Ltd File No. 01/82/050/01089/AM 15 RLA No.04/24/040/00172/AM 15 Adv.Auth. No. 041015940 dated. 08.10.2014 Decision: The Committee reconsidered this case for fixation of adhoc norms as per agenda. The Committee decided to defer this case for comments from D/o Pharmaceuticals.

Case No. B- 05

M.No.19/AM-17 Date 08.03.2017 M/s. Macleods Pharmaceuticals Ltd File No. 01/82/050/00445/AM 15 RLA No.03/95/040/01010/AM 14 RLA No.03/95/040/01021/AM14 Adv.Auth. No. 0310774159 dated 12.03.2014 Adv.Auth. No. 0310775289 dated 21.03.2014 Decision: The Committee reconsidered this case for correction of ad-hoc norms as per agenda. The Committee decided to correct the norms based on the earlier decision taken by NC in its meeting No.23/82 dated 06.03.2013, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per decision of NC.

Case No. B- 06

M.No.19/AM-17 Date 08.03.2017 M/s. Ami Organics Pvt Ltd File No. 01/82/050/00868/AM 14 File No. 01/82/050/01110/AM 14 File No. 01/82/050/00576/AM 15 RLA No.52/24/040/00024/AM 14 RLA No.52/24/040/00037/AM 14 RLA No.52/24/040/00010/AM 15 Adv.Auth. No. 5210040263 dated. 10.10.2013 Adv.Auth. No. 5210040485 dated. 10.12.2013 Adv.Auth. No. 5210041062 dated. 23.05.2014 Decision: The Committee considered this case for revision of norms as per agenda. The Committee based on the earlier recommendation of Department of C&PC forwarded vide U.O.No.14010/2/2014-Ch-II dated 21.10.2015, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per decision of NC.

Case No. B- 07

M.No.19/AM-17 Date 08.03.2017 M/s. Alcon Bio Sciences Pvt Ltd File No. 01/82/050/00925/AM 11 RLA No.03/94/040/00472/AM 11 Adv.Auth. No. 0310595543 dated. 06.10.2010 Decision: Decision: The Committee considered this case for ratification of norms as per agenda. The Committee based on the earlier recommendation of Department of Pharmaceuticals forwarded vide O.M.No.35011/234/2013-PI(Norms) dated 24.06.2013, uploaded at the end of necessary action as per decision of NC.

87

Case No. B- 08

M.No.19/AM-17 Date 08.03.2017 M/s. Bayer Cropsciences Ltd File No. 01/82/050/00460/AM 15 RLA No.03/94/040/00797/AM 14 Adv.Auth. No. 0310772503 dated. 28.02.2014 Decision: The Committee considered this case for fixation of adhoc norms as per agenda. The Committee decided to defer this case for comments from Technical Authority.

Case No. B- 09

M.No.19/AM-17 Date 08.03.2017 M/s. The Andhra Sugars Ltd File No. 01/82/171/00037/AM17 Decision: The request of M/s The Andhra Sugars Ltd. dated 04.05.2016 and representation of the firm forwarded by Federation of Indian Export Organisations (FIEO) vide letter dated 27.01.2017 have been considered for modification the description of export product mentioned in SION A-39 from “Acetyl Salicylic Acid” to “Acetyl Salicylic Acid (Aspirin)” as per agenda. The Committee also considered recommendation of Department of Pharmaceuticals forwarded vide O.M.No.35011/322/2016-PI(Norms) dated 17.01.2017. The Committee based on the above recommendation of D/o Pharmaceuticals decided to modify the description of export product mentioned in SION A-39, to read as “Acetyl Salicylic Acid (Aspirin) without any other changes.

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Page 1 of 1 -.- -.- ..---.--.--- -.- ....- .--- ----.---- -.- "'-- ...- .- -·-_···--···1 Central excise Authorities. ·~=::·:i4!~'-arry-.-N-a-.;--;-:s~A; LABS=;,~cc;Nte.7;2~.=s~~-;;cmi jPRVAlE lIMlTI.D L4.LC4l2015 IAPprovcr! j I : 124.072015 I ~.~ fHQ file

• R.LA File IILiC.NO/DBtC:0910060939lOde! Date: ~.-,) 1:0 1182105010 I075/AM 151 :091.W040/00287/AMISi IUl9 ..2014 ~ __ .~ Decision : The committee decided to ratifv the norms based on the recommendation of I V I Department of Phar aceuucsls vide letter No.35011/97/201S-PI (Norms) dt. AUGust 20] asI 1210 t"r details given below or as applied bV the firm whichever is less:- r 10/ I i E)(portpro'!.uct Qtv.~~·· /OC
  (lS,4R)-4-Amino-2- lkg ,1 Vincclactwn I CYCIOpentcnc-I-Mclhanu.l /2 Sodiul!1..Borohvdridc. -t--:-:~- I, ..:,!,anrate (Cap-2). -'I D (-) -tartaric Acid.~ L-'R~aytdk~~.u:h~r:t:~a~::~~n:.~. . ... . ..... . ....J . - --.-------------- ....-- --..-,-.. -~"-"---'--'-r---"---- I Cusc l'/o.:4SI15182· Pal ry I"a,,,e:GLA D j re~t No/T)ate:7182· ;Stulus:C:!sc ! LC~/2014 ,PlIARMA LIMITED ;ALC4/2015 jncfcrred I t 124.07.20/5 i 1 211 HQ Fik !RLAf~------Lic.N"fl)aie:09J0060::::9::-:57::-r.:L>c-:f.:-ef-~- :0Ii82.1.50/0J332IAMf5/ I:09124i040J00305./AMI5i . 12.09.2014 . l)a.I.~:JO'O. 9.1015 1 / I ro~d;To-n-:-It'~;;~-d~c-id-ed;o-(l-lc-fc-rtt;~-ca-· --e-fo-r-w~-nt-of-' c-o-~'-t,-s -o-f-f)io-C&j~-c---'--' LJ.!::u.rmaceutical). __ _ ~ _ . .. _... .. .._._ -rm ,,-;-".;4/RJ82.,'iC4/20I4-lp;iY-NamdfONOUR-L.AIJ rM.-;N;;ii5;~:7/8-2-'--r.'I;IU:"CIl'C ,LlMIT!'D !/\LC4,'2015 Deferred !24.07.2015 I 212 HQ File

---

RLA Fih:---------fl.~:-:-;;fDale:091006U963iDcfer ----I .0Ii82~50/006681 Ml t.:~. __O<)i24/040j0031.8M ~_.J~-=0920 I~. £..:JO.O::':?OISI I ! [Decision : It was decided to defer the case for want of comments of DIu C&PC kPham,~ccuticaI) I

--' [ CU'" No,:61111i12~;\LC4l2014 1PWY"N';mcHONOUR LAB iM;;i'N~/l)"te:7/S2. ~;;-;;(:;;;;--; I LIMITED ~l\lC.4/2015 !DcfCnCd i ,24,07.2015 i ! 213 mr'i1; - IRLA File' .rl~jc.Nom[(!:091(i06'09M!~i~r----'1 ' 1:01I&2/050j00670!AM 15/ 1:09l24/040/00314!AMI51 12.C9.20 14 tDale:JO.09.20 15 I r"-'-"-'-'- --- -.-.-.--.--- .---.------- ..~--.--- -...-- I iOedsion :Hwas decided to defer the case for want of cornmcnu of D/o C&PC i<Pha~.n~cet~~cal). . . .. . _ __.... ... J r-'c~scNII.:8111182'AJ-,C4iwl·4-·lrpa.tY-;I~;"HCjoUR' LAB-r~.fcei-i;;"l)a~:··-- --ISt3tu5:cc---;.: I i I.lMlTED IALC-1i20!5 Oderr'~d I I I <24.07.2015 I 1214:IIQ File fRtA File ------'Lic~NofDm:0910060,J66 fD~fi:r I I 1~1./~::-.~50JO0672~::~I:~. i:09i24104()jOO) i5//\ II.! I5:.. 11209.21]14 _ !D~lc:30.O':'.~.:' 1 IUccision :It wa decided 0 defer the case for want of l:()l~~~::.tS {)'!.~~oC&PC .....__ 1 file:1IIC :/Users/Lenovol AppDataiLocallMicrosoft/Wi ndows/IN etCache/LowIIE/XHE ... 14-03-2017

Ic)-- l .••.. ---~--~-. --,,,,,,- ~! Government of India Ministry of Chemicals and Fertilizers Department of Chemicals and Petrochemicals Subject Advance Authorization application from Mis. AMI organics Pvt. Ltd .. for the import of raw material against the export of 3,4-HYDROXY 5-NITRO BENZALDEHYDE- 99% MIN. (Advance Authorization No. 521004339 dated 5.12.2015) Ref UO. No. 01/82J050/525/AM16/DES-'"/600 dated 14.7.2015 MIs. AMI organics Pvt. Ltd. have submitted present application for the import of raw material against the export of 3,4-HYDROXY 5-NITRO BENZALDEHYDE-99% MIN. The application has been examined and the Department recommends the following norms for the present Advance Authorization application. I 1. Item of Export ! ·Qty. litem of Import I ; I 13'~HYDRONZAL~:g11 kg ~ -V-A-NTL-Li-N-g9~5-%--- I E-99% MIN. ,:i i 2. DIMETHYL FORMAMIDE- I 99.5% ----.------. .--'-- --_ .-_ -._. I Q~ I i 1088, KG1 I 3.170 KG I

1. __ ----' This issues with the approval of competent authority. l'J..uj~ fb.."i ...> ~~) (A.K. AGARWAL) Addl. Industrial Adviser Tel. No. 011-2338 1430 Shr! Mahender Vikram Singh .FTDO ,(DES-III) % DGFT, Udyog Bhawan,New Delhi -11, Deptt. ofC&PC U.O. No. 14010/2/2014-CH-II dated 21.10.2015

F. No.35011/1/2016-PI (Norms) Government of India Ministry of Chemical & Fertilizers Department of Pharmaceuticals Udyog Bhawan, New Delhi, Dated: 1 June, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14

Case of Mis Suven Life Sciences Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/5010185/AM- 16/DES-3/1653 dated the 18/2/16 vide which application from Mis Suven Life Sciences Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of (1-Phenylmethyl)-1 H-lndeno[2, 1-b]Pyridine-6-Carbonitrile. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- DGFT is advised to call following details from the firm viz:-

1. The import item is catalyst only for which no recovery or regeneration is shown. The firm may be advised to elaborate the recovery of imported catalyst with technical justification.

This issues with the approval of competent authority. (Rajkumar) Under Secretary to the Government of India PH:- 23071162 Directorate General of Foreign Trade, Department of Commerce, (Shri MV. Singh, FTDO), Udyog Bhawan, New Delhi

11

2:}- HQ File 01/82/0S0/00S67/AM 10: RLA File 03/94/040/01121/AM091 Meet Nof[)ate ; 8/c!· ALC4/2011 02 08~U1: Lic No/Date 031 05~4602 17062009 Status C.~aSe I\pproved Case No i128/82-AIC4/2009 Party Name:HEMMO PHARMACEUTICALS PHIVATE LIMITED Decision Committee considered case as per agenda and in light of production and consurnptior, data certified by Central Excise Authority and in consultation with technical authority present .n meeting, decided to ratify norms for regularization purpose under para 4.7 of HBP as per details below or as applied by firm whichever is lower- Eport p.r~d_u~t EXe?~ Desmopressin 1 kg 3 ._ ... .. ----. ---.- ._-

• ---·--1-- --. -.- Qty SI.No _ Jr:nport items .. . Q!Y.~~~w~j I . _.

Boc-Gly-OH 2.205 kg I I-- -- -.- . -- --- ...- 2. Boc-D-Arg (Hcl)-OH 3.333 kg ---------. -- .- 4.255 kq- .._.--- .. 3. Fmoc-Pro-OH ---.-

• .- .. - .-._--

Fmoc-Cys(Trt)-OH 6.737 kg ------ .. --- - --- ----.- 5. Fmoc-Asn-OH 5.531 kg .----. 6.460 kg . 6. Fmoc-Gln-OH -.-- 7. Fmoc-Phe-OH 4.042 kq 8. Fmoc-Tyr(tSu}-OH 5.886 kQ 9. MPa(Trt) 3.758 kQ 10. Hydroxybenxotriazole (HOST) 49.078 kQ 11. DiisopropY\carbodiimide (01PCDn 18.581 Liter 12. Diethy1 Ether Dried 2284.000 Liter 13. Piperidine 77.040 Liter 14. Trifluoroacetic Acid (TFA) 82.650 Liter 15. .- Ethanqithiol (EDT}

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1.350 liter --.- .----- .---- 16. Diisopropylethylamine (DIEA) 12.765 Liter 17. Thioaniso\e 2_670 Liter 18. Diaion 10.638 ko 19. Dowex 2.791 ko 20. Merrifield Resin 4.113kq 21. Cesium Carbonate 2.180 kq .. 22. Kromasil 1.070 kg 23. Acetonitrile 4758.865 Liter 24. Ethyl Alcohol (Un-denatured) 840.000 Liter ---- c

Case NO.:5/7/82-ALC4/2011

Party Name:PAYAL Meet NolDate: 15/82- iStatus:Case IPOLYPLAST PVTLTD, ALC4/2011 !Approved 12.07.2011 , I i ["'" M •• _ .•.... H····M ••••••• ·_ •••• H ••• ,HQ File RLA File .Lic.NoIDate051 0289321 :01/82/050100171 lAM 121 ,:05/24/040100026/AM 121 02.05.2011 rD~~·isio~-:-Co·mmittee~onsidered c-ase asperaqenda and in light of written·comme~-is fo;;V~l;:de-d·bY Department of C&PC vide their U.O NO.14010/33/2011/Ch.1I dated 14062011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower- Export product Export Qty SINo. Import items Qty. allowed Di-Iso Butyl Phthalate 1kg. 1. Phthalic Anhydride 0.560 kg 2. Iso Butanol 0.560 kg IRA concerned may take further necessary action as per above decision of NC. ......

Case No.:250/5/82-

,ALC4/2015 ~ Party Name:PAYAL PETROCHEM PRIVATE LIMITED 'RLA File :05/24/040100528/AM151

.Meet NolDate:8/82- .Status.Case i ALC4/2015 'Approved I 16.09.2015 i .--

·····-·,··········-·· __··········--·1 Lic. NolDate:051 03933391Defer Date: I 24.02.2015 , f"H'b Fii'e" .,~..~....~. ;:0 1/82/0501003901 AM 161 Decision : The committee decided to ratify the norms based on the recommendation of' '315 Department of 46011/79/2014-PC-1I dt. 26.8.2015 as per details given below or as applied by the I lfirrn whichever is less- Export product Oty. Import items Oty.kg I Di-Octyl Teraphthalate 1kg 1 1 Pure Tere Phthalic Acid 0.400 (DOTP) 2 I 2-Ethyl Hexanol 0.613 I :RA may take further action accordingly.

lease NO.:5/7/82-ALC4/2011 'Party Name:PAYAL POLYPLAST PVT. LTO., I 'Meet NolDate: 15/82- ALC4/2011 :12.07.2011 [Status:Case- iApproved I :HQ File 1:01/82/050100171 lAM 121 i 1-- Lie.NolDate:051 0289321 I 02052011 RLA File i:05/24/040100026/AM 121 r~- --.----.--

..._.n__

. .n .n.... n ".'.n . .. n.. , ... n. .__ . . . Decision : Committee considered case as per agenda and in light of written comments forwarded by : iOepartment of C&PC vide their UO NO.14010/33/2011/Ch.11 dated 14062011 and in consultation 64 with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower- i :1 Export product Export Oty. SI.No. Import items Oty. allowed !I Oi-Iso Butyl Phthalate 1kg. 1. Phthalic An~dride 0.560 kg 2. Iso Butanol 0.560 kg iRA concerned may take further necessary action as per above decision of NC.

F. NO.35011/141 12016-PI (Norms) Government of India IeJjJ Dated: July, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14

Case of Mis Sun Pharmaceuticals Industries Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/209/AM-17/DES- 3/217 dated the 6/7/16 vide which application from Mis Sun Pharmaceuticals Industries Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Atorvastatin Calcium I Atorvastatin Calcium Trihydrate (Bulk Drug/Pharmacopeal Grade) , Atorvastatin Calcium I Atorvastatin Calcium Trlhydrate Tablets tOmg, 20mg, 80mg. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- h.iJ . S.No. Import item Norms Recommended for 1kg Export .?~rvy 1 ASC-3, (4R-Cis )-1, 1-dimethyl ethyl-6-cyanomethyl- 0.708kg 2,2-dimethyl-1,3-dioxane-4-acetate 2 Activated carbon Q._04Aa 3 DKT-3, 4-fluoro-a-(2-methyl-1-oxopropyl)-¥-oxo-N-~- 0.994kg diphenyl benzene butanamide 4 Cyclohexane 0.228~ 5 Isopropyl alcohol 0.564kg 6 Methanol 2.738kg -J 7 Methyl- T-butyl ether 1.321kg 8 N-Heptane 0.806kg 9 Tetra hydrofu ran 1.068kit 10 Toluene 1 417kg

(Rajkumar) PH:- 23071162 (Shri MV. Singh, FTDO), Udyog Bhawan, New Delhi.

HQ File :01/82/050100822/AM 131 RLA File :09/24/0401002261 AM 13/ Meet No/Date:24/82-- lstatus:Case I A LC4/20 12 iApproved I 15.11.2012 Lic.Nol-Date:-09-100-53-4-41-IDefer Date: 06.08.2012 -Case No.: 18/24/82-ALC4/2012 [Party Name:SALICYLATES & CHEMICALS PRIVATE ,LIMITED w.

w_._ -_. '---

----------l Decision: In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/1 07/2008-Ch. II dated 20.11.2009, it was decided 218to ratify norms under

Para 4.7 of HBP vI as per details

given below or as applied by thel firm, whichever is less: RA may take appropriate action as per the decision of Norms Committee. I _I Export Product Export Qty. SI.No. Import items Qty. I allowed kg/kg Brosalidox L 1 kg 1 Propylene Glycol (Liquid) 0.895 2. 5-Bromo-5-Nitro-1,3-Dioxane 0.100

IHO Fil~ I:0 1/82/050100579/AM 101 .RLA File ':03/95/040100307/AM 101 Meet NolDate21/82-- ·--·TSt·at~~:ca~~I ALC4/2011 jApproved 23.08.2011 . LicNolDate0310534431-r 20.08.2009

Case NO.:9/29/82-ALC4/2009

Party Name:PRIVI ORGANICS LTO Decision: Committee considered case as per agenda and in light of earlier decision taken in 34/82 meeting held on 17.11.2009 and meeting held on 16.11.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- 1 I I Export product Exp. SLNo. Import items oty. allowed I Otv. I Amber Fleur (2,3,8,8- 1 Kg. 1. Myrcene 80% 1.00 kg I Tetramethyl 1,2,3,4,5,6,7,8- 2. Methyl Ethyl Ketone 0.600 kg I Octohydro-2-Napthalenyl I 3. Toluene 0.02 kg Methyl Ketone 4. Phosphoric Acid 0.150 kg I I ,RA concerned may take further necessary action as per above decision of NC.

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_ _ _ ---1

Case No.:38/24/82-ALC4/2012 Party Name:SALlCYLATES & Meet No/Date:24/82- CHEMICALS PRIVATE A LC4/2012 ,LIMITED 15.11.2012 .... .- --~----1 Lie. o/Date:0910053440 iDefer Date: ,06.08.2012 [Status.Case I .Approved 'HQ-Fi;

':0 I182/0501008421 AM 131 RLA File .:09/2410401002281 AM 131 Decision: In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/l07/2008-Ch. II dated 1.7.2009, it was decided to 219 ratify norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, whichever is less' Export Product Export Oty. St.No. Import items Oty. allowed , kg/kg Allantoin (Powder) 1 kg 1. Glyoxylic Acid 50% (Liquid) 1.28 of Norms Committee . . -

..

[Case No.:23/26/82-ALC4/2012 Party Name:SALICYLATES& ! CHEMICALS PRIVATELIMITED ~

• -r------; Meet NO/Date:26/82- ALC4/2012 13.12.2012 IStatus:Case IApproved

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iHQ File ::01/82/050/00931/ AM 13/ RLA File !:09/24/040/00315/ AM 13/ ~-- --------.------i ILic.No/Date:0910053978 .IDefer Date: 105.10.2012 l ~ IDecision : In the light of written comments rec;i~ed fro~ D;P~tment -o-f-C-h-e-m-ic-al-s-an-d-1 Ipetrochemicals vide their U.O No. 14010/34/2011-Ch. II dated 10.12.2012, it was decided to ratify 3021norms under

Para 4.7 of HBP v1 as per details

given below or as applied by the firm, whichever is Iless: I Export product Exp. Qty. SI.No. Import items Qty. allowed Brosa lidox L 1 kg 1. Propylene Glycol 5-B romo- 5-N itro-1,3-Dioxa ne 0.900 kg ,~----------+--------~----~-----------------------------r-----------.....; 2. 0.100 kg IRA may take appropriate action as per the decision of Norms Committee. ----_.

I

Case No.:9/41182::--~-

Party Nam~~BEST ! ALC4/2011 VALUE CHEM PVT. LTD.

~-~--,----- .Meet No/Date:47/82~ IStatus:Case ALC4/20 I I Approved 21.02.2012 -_. - - .-

-- .. r---- ----.-.- .. ,HQ File RLA File Lic. 0/Date:341 0032044 !Defer Date: :01/82/0501010101AM121 :34/24/040100154/AM121 25.10.2011 iI

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-..- 'Decision: The Committee considered the case as per agenda and in the light of written i icomments received from Department of Chemicals and Petrochemicals vide their U.O . 'No. cn 14011122/2012-S0 (Ch.II) dated 6.2.2012 and in consultation with the ! 121 ,technical authorities present in the meeting decided to ratify norms norms under Para , ;4.7 of HBP v I as per details given below or as applied by the firm, whichever is earlier: ;~-------~---~-----,----------------------,---------. Export Product Export S.No Import Items Quantity Quantity allowed i Verdyl Isobutyrate I kg I Dicylopentadiene :1 2 Iso~b~l_lt~YI_·ic~A_c_id __ ~ __ ~ __ -L_0_.4_9_3_k~g~ __ ~ JRA may take appropriate of Norms Committee. 0.705 kg

Case No. B 38

Mis. Vivimed Labs Limited Meeting no. 4/AM 13 dated 16.5.2013. F. No. 01/82/50/00284/AM 13/DES III R.A File No. 09/24/40/6461 AM 12 Advance Licence No. 0910051917 dated 28.3.2012 Decision: In the light of written comments received from Department of Chemicals and Petrochemicals vide their UO No. 140101138/2011-Ch. II dated 27.11.2012, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Sl.No. Import items Qty. allowed Qty. Piroctone Olamine 1 kg 1 3,3-Di Methyl Acrylic Acid 1.125 kg or Vipirox 2. Isononanoyl Chloride or 3, l.544 kg 5,5-Trimethyl Haxanyl Chloride -, Hydroxylamine Hydro 1.224 kg -'. Chloride 4. Methanol 2.155 kg 5. Di ChI oro Methane (MDC) 0.700 kg 6. Ethylene Oi Chloride (EDC) l.750 kg 7. Toluene 0.350 kg 8. Hydro Quinone 0.112 kg action as per the decision of Norms Committee.

-- ,~.~.-.¥-~-.~ ..- .. ,,- _ ......... ... ~.... -' [Case No.:82/24/82-ALC4/2012 I Party Name:INDOFIL INDUSTRIES LTD. Meet No/Date:25/82- ALC4/20 12 29.11.2012

IStatus:Case .Approved HQFT~ - -- --~

• RLA-Fil~~

.Lic.No/Dcrte:031-0il 0996 [Defer Date: :01l82/050100886/AM131 :03/94/040!00547!AMI3! 28.09.2012 i -.---- _. - -

..- .- ... . .-. __.- ..-.-..-.-- .

Decision: In the light of earlier decision taken in meeting no. 3/82 dated 17.4.2012, it was 191 [decided to ratify norms under Para 4.7 of HBP v I as per details given below or as applied by nhe firm whichever is less: Export Product Export S.No Import Product Quantity Quantity N Cyano Acetyl Ethyl 0.867 kg Urea 98% Min. allowed I Cymoxanil Technical I kg I~----------------~--------~--~~----~--------~--~------------~ 'RA may take appropriate of Norms Committee. --------'

'Case NO.:7/24/82-ALC4/2012 Party Name:SHIVA PHARMACHEM LTD. Meet No/Date:3/82- ALC4/20 13 ;Status:Case .Approved 02.05.2013 .HQ File ,:01/82/05010081I1AMI31 I Lic.No/Date:34I 0035379 :i)~f~r·D;-t~·:··1 31.10.2012 RLA File :34/24/040100 168/AM 131 ••••• y •• ,_ ••• _ •••• " •• _ •••••••••• y ••• -. -".,._ ••. _ •• ,_ •• ,-' '_ •• '-

Decision: In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.o o. 140 10/65/2007-ch. II dated 7.5.2013, it was decided 'to ratify norms under

Para 4.7 of HBP v I as per details

given below or as applied by the firm, whichever is less: 149 i Export product Exp. SI.No. Import items Qty. allowed i Qty. i I ! Iso Nonanoyl 1kg l. Iso Nonanoic Acid 0.942 kg I ! Chloride (Appearance: clear colourless II i ; (Appearance: liquid) I I Clear Colourless Liquid) i ! ;RA may take appropriate of Norms Committee.

y qs !HQ File :0 I182/05010 1322/ AM 121 RLA File :3412410401002281 AM 121 Meet No/Date:49/82- A LC4/20 I I 06.03.2012 ------ Lic.No/Date:34I 0033125 Defer Date: 06.02.2012 'Status.Case Approved

Case No.: 13/49/82-

ALC4/2011 'Party Name:RIDDHI PHARMA Decision: Committee considered case as per agenda and in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010176/201 O-Ch.ll dated 27.9.2010 and in consultation with technical authority present in meeting, decided to ratify norms ,227 'under Para 4.7 of Handbook of Procedures as per details below or as applied for by firm whichever is I llower.- Export Product Export S.No. Name of Item of import Quantity allowed Qty. 1,3 Dichloro Acetone 1 kg 1. 1,3 Dichloro-2-Propanol 1.069 kg 2. Sodium Dichromate 1.70 kg Ii I' . . RA may take appropriate action as per the decision ofNOI ms Committee .

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Case No.: 19/9/82-ALC4/20

14 Party Name:SALICYLATES & Meet No/Date: 11/82- CHEMICALS PRIVATE ALC4120 14 LIMITED 26.11.2014 :Status: Approved HQ File :0 1/82/0501008161 AM 151 RLA File :09/241040100 142/AM 151 Lie. No/Date:091 0060792 'Defer Date: 04.08.2014 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals I ~~ [vide their U.O No. 14010/34/2013/Ch II dated 27.11.2014, it was decided to ratify norms under

Para 4.7:

.).)4 'of HBP v1 as per details given below or as applied by the firm, whichever is less: . , Export Product Export S.No Import Product Quantity ! Quantity Allowed ; HOMOSALATE (3.3.5-Trilllelh)I 1 kg 1. ISOPHORONE 0.572 kg I Cyclohexyl Salicylate) i 2. SALICYLIC ACID 0.572 kg iI action as per the decision of Norms Committee

HQ File :0 I 182/05010 1314/AM 121 Party Name:SPAV ORGOCHE DIA) PVT. LTD. RLA e :03/95/0401008621 AM 121 Meet No/Date:49/82- ALC4/2011 06.03.2012 'Status.Case Approved

Case No.:S/49/82-

ALC4/2011 Lic.No/Date:031 0683338 Defer Date: 24.02.2012 .~.. _. Decision: Committee considered case as per agenda and in light of earlier decision taken in meeting no. 53/82 dated 29.6.2009 and in consultation with technical authority present in meeting, decided 244 to ratify norms on repeat basis under

para 4.7 of HBP as per details

below or as applied by firm i whichever is lower:- , Export product Exp. SI.No. Import items Qty. ; ! Qty. allowed Sorbitan Mono I Kg. I. Sorbitol 70% Solution 0.4 70 kg Stearate 2. Stearic Acid 0.634 kg j. RA concerned may take further necessary action as per above decision of Nt".

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Case No.:SO/14/82-

ALC4/2013 Party Name:SHREE BANKEY Meet No/Date: 14/82- BEHARI LAL BOARD ALC4/2013 MILLS 24.10.2013 'Status: Apporved HQ File :0 1/82/0501006351 AM 141 RLA File :05/24/0401001951 AM 141

•• Lic.No/Date:0510364317 !Defer Date: 03.09.2013 Decision: In the light of written comments received from Department of Chemicals and. Petrochemicals vide their U.O No. 14010/28/2012-Ch II dated 28.10.2013, it was decided to ratify norms under

Para 4.7 of HBP vl as per details given

below or as applied by the firm, 315 whichever is less: Export product Exp. Qty. SI.No. Import items Qty. allowed MENTHOL 1 kg 1. META - CRESOLABOVE 98.5% PURE 1.50 kg 2. ISO PROPYLALCOHOL 1.80 kg , , A may take appropriate action as per the decision of Norms Committee.

Case No.: 1/7/82-A LC4/20

I3 Party Name:SHIVA Meet No/Oate:7/82- Status:Case PHARMACHEM LTO, ALC4/20 13 Approved ! 27 .06.2013 I HQ Fil~' RLA File Lic.No/Oate:3410037111·iD~fD~t·-1 ;:01/82/0501001301 AM 141 :34/24/040100048/AM 141 13.06.2013 . ! I iD~cisi~n-:-I~ the light of written com~ent~ r~ceived from Department of Che~i~;Ts- and I iPetro~hemicals vide their u.o No. 14010/89/201 0IC1:. II ?ated 24.6.2011, it w~s decided I 140 to ratify norms under

Para 4.7 ofHBP

vI as per details given below or as applied by the! firm, whichever is less: Export product Export SI. o. Import items Qty. allowed Qty. I Isooctyl 1 kg l. 2-Ethylhexanolilsooctyl 0.972 kg Chloride Alcohol I of Norms Committee.

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Case No. :36/3/82-A LC~/20 14

Pan) allle:GLOBAL CALCIUM PRIVATE LIMITED, RLA File 07/24/040/00337/ AM 14/ Defer Date: Meet No/DateJ/82- ALC4/20 14 08.05.2014 Lic.No/Date:071 0 I 0 1210 09.01.2014 Status.Case Approved HQ File 01/82/050/00040/ AM I5/ Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/56/2011-Ch. II dated 23.05.2012, it was decided to ratify norms under

Para 4.7 of HBP v1 as per details

given below or as applied by the firm, whichever is less: 230 Export product Export S.No. Import items Quantity Quantity Allowed CALCIUM LACTATE 1 kg 1 CALCIUM GLUCONATE

• Oral 0.686 kg GLUCONATE Grade 2 CALCIUM CARBONATE 0.310 kg 3 0.560 kg I' I.ACTIC ACID I' FERROUSGLUCONATE 1 kg 1 LACTIC ACID 1.028 kg MAGNESIUM LACTATE 1 kg 1 LACTIC ACID 1.19 kg ZINC LACTATE 1 kg 1 LACTIC ACID 0.990 kg MAGNESIUM LACTATE 1 kg 1 0.390 kg GLUCO ATE LACTIC ACID action as per the decision of Norms Committee.

111- Meet No/Date:23/82- ALC4/2012 o I. I 1.2012 Lic.No/Date:OSI0332132 21.08.2012 . '...- .•..-..---.-~ [Status.Case 'Approved ! ~ ..---..-,.~. -- .--. ,- 'Case No.: 114/18/82-ALC4120 12 Party Name:PCL OIL & SOLVENTS LTD., ;HQ File ::0 I1821OS01006091 AM 131 RLA File :05/24/0401001861 AM 131 IDefer Date: ,.---- ....- - .-

.•. [Decision : In the light of written comments received from Petrochemical Division of [Department of Chemicals and Petrochemicals vide their OM No. 460 11/119/20 12-PCII 18S'dtdI8102012't d ided t tif d P 47 fHBP detail i a e , I was eCI e o ra I y norms un er ara 0 v as per e ar s .given below or as applied by the firm, whichever is less: !i ! Export product Exp. SI.No. Import items Qty. allowed Qty. PVC Plasticizer 1 kg 1. Phthalic Anhydride 0.400 kg 2. 2 Ethylhexanol (Octaonol) 0.700 kg IRA may take appropriate action as per the decision of Norms Committee.

Case No.:4/8/82-ALC412011

Party Name:AUROBIN PHARMA LIMITED

• TStatus:Case ,Approved Meet No/Date:48/82- ALC4/2011 28.02.2012 Lic.No/Date:0910046587 02.05.20 II HQ File :01182/0501002041 AM 121 RLA Fil :09/2110401006061 AM II I ~-------- 'Decision: Committee considered case as per agenda and in light of written comments forwarded .by Department of Pharmaceuticals vide their OM NO. 35011/361/2011-PI(Norms) dated 27.2.2012 .and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 .of HBP as per details below or as applied by firm whichever is lower:- 27 Export product Export SI.No. Import items Qty. allowed Ii Qty. (kg/kg) I: Amisulpride 1 kg 1 4-AMINO-5- L...> (ETHYLSULFONYL)-2- I! METHOXYBENZOIC ACID 0.892 / [(2RS)-1- ETHYLPYRROLIDIN E-2- YL]-METHANAMINE 0.528 3 METHYLENE CHLORIDE 6.49 I 4 1 TRIETHYLAMINE 0.417 , 5 ETHYL : , CHLOROFORMATE 0.411 I' 6 ACETONE 2.684 I' 7 I, ACTIVATED CARBON 0.076 'RA may take appropriate of Norms Committee. ..- _. "¥¥' ,-

)~ --!"'.' .. .Case NO.:S2/31/82- 'ALC4/2012 HQ File :0 I182/05010 1092/ AM 13/ Party Name:MELOG SPECIALITY CHEMICALS PVT. LTD. RLA File :03/95/0401007081 AM 131 Meet No/Date:6/82- ALC4/20 13 13.06.2013 Status: Deffered i and Re-indexed I , ' I r: -----, Lic.No/Date:031 0719783 [Defer ! 08.01.2013 Date:13.06.2013 ~ Decision : : In the light of written comments received from Department of Chemicals and 151 !Petrochemicals vide their U.O No. 140 I0/22/2012-Ch. II dated 21.03.2013, it was decided to ratify norms lunder Para 4.7 of HBP v I a per details given below or as applied by the firm, whichever is less: , II Item of Export Quantity S,No Itern of Import Quantity allowed II NUA (4-PIPERJDfNOL I kg I LA-7RD (1- 0.700 kg II 2,2,6,6- TETRA M ETH Y L- PIPERIDINYLEXY 4- , I (UNDECYLOXY) HYDROXY 2,2,6,6 I i TETRA METHYL ! I 2. LAUROX (LAUROYL 1.589 kg ! : PEROXIDE) I 3. 0-40 (SOL VENT) 1.459 kg i I I 4. METHANOL 0.213 kg ! ~RA may take appropriate action as per the decision of Nor illS Committee.

11 Ilj rCas~"N():9i29/82-ALC4/2009 'Party Nam~: PRIVI ORGANICS LTO Meet NolDate:21/82- ALC4/2011 23.08.2011 [Status: Case iApproved I HO File 1:01182/050100579/AM 101 RLA File ,:03/95/040100307 lAM 101 Lic. NolDate:6-310S"344-31- :---.---

20.08.2009 'Decision: Committee considered case as per agenda and in light of earlier decision taken in 34/82 rrneetinq held on 17.11.2009 and meeting held on 16.11.2010 and in consultation with technical l authority present in meeting, decided to ratify norms under

para 4.7 of HBP as per details

below or as applied by firm whichever is lower:- 1 I I Export product Exp. SI.No. Import items Oty. allowed I Oty I Amber Fleur (2,3,8,8- 1 Kg. 1. Myrcene 80% 1.00 kg Tetramethyl 1,2,3,4,5,6,7,8- 2. Methyl Ethyl Ketone 0.600 kg I Octohydro-2-Napthalenyl 3. Toluene 0.02 kg , Methyl Ketone 4. Phosphoric Acid 0.150 kg , i IRA concerned may take further necessary action as per above decision of NC.

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Case No.: 10/26/82-

;ALC4/2011 'Party Name:JINDAL DRUGS .Meet No/Date:29/82- LIMITED ALC4/2011 18.10.2011 •................................ [Status: Case 'Approved I Benzene, 1-Methoxy-4-(1-Propenyl)- (E) 1.03 kg rHO File iRLA File iLic.No/Date:0310642433 r ....._- ,:01/82/050100693/AM121 !:03/94/040100254/AM121 ,15.07.2011 ! r·M ••••••••• _ •••• __ ••••

•••

.---.

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•

.' .- •••••

•••• --- ••••

•• --. Decision : Committee considered case as per agenda and in light of written comments forwarded by JDepartment of C&PC vide their UO. NO.14010/106/2011-Ch.11 dated 04.10.2011 and in consultation 146!with technical authority present in meeting, decided to ratify norms as per details below or as applied by the firm whichever is lower- Export product Exp.Oty. SINo. Anethole (Pure) 1 Kg. 1. Import items Oty. allowed RA concerned may take further necessary action as per above decision of NC.

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lCase No.:S9/1/82- iALC4/2012 , ; Party Name:SHREE Meet No/Date: 1/82- BANKEY BEHARl LAL ALC4/2012 BOARD MILLS 03.04.2012 Status:Case Approved .-

-,-,~,~ -- .-.-- HQ File RLA File Lic.No/Date:051 0314314 Defer Date: .;0 1/82/05010150 II AM 121 :05/2410401003391 AM 121 12.01.2012

-, •• -.-~

.Decision : In the light of earlier decision taken in meeting no. 35/82 dated 29.11.20 II, it I il41 'was decided to ratify norms under Para 4.7 ofHBP vI as per details below or as applied by' . .the firm whichever is less: , II Export product Exp. Qty. SI.No. Import items Qty. : allowed I' i Thymol (Purity 98.5% Min.) I Kg. I. Meta Cresol 0.785 kg I: :RA concerned may take further necessary action as per above decision of C.

10 Meet NolDate'24/82':- --;Status:Case I ALC4/20 12 Approved I 15 11.2012 . ~I~

RLA File Llc.No/O;te:031 06970 12 :Defer Date: I :0I182/0501003261 AM 131 :03/9410401000271 AM 131 31.05.2012 !Decision: In the light of written C~ll~ll~l;t-s I~ceived from Department of-Chemicals and 'Petrochemicals vide their U.O No. 14010/106/2011-Ch. II dated 26.10.2012, it was decided 186 to ratify norms under

Para 4.7 of HBP v I as per details

given below or as applied by the firm, whichever is less: I 'Case No.:S9/11/82-ALC4/2012 Party Name:J1NOAL DRUGS LlMITEO , Export Product Export Qty. SI.No. Import items Qty. allowed i kg/kg ; Pure Cineole 1 kg 1. Eucalyptol Oil 105 I I ,RA may take appropriate of Norms Committee. ._ ..

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It?- ItA.'> 1'$") I !Case No.:10/4S/82- :ALC4/2011 Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT

Meet No/Date: 1/82- ALC4/2012 03.04.2012 [Approved n_n'n. "~.,. __ •• ..~~~.. "m_,nA. ,_~ _ n , _ _ ~, ~ ~ • iHQ File RLA File Lic.No/Date:051 0312171 Defer Date: j:01/82/050101187/AM121 :05/23/040100354/AM121 22.12.2011 iDecision : In the light of written comments received from Department of Chemicals and 'Petrochemicals vide their U.O No. 14010/38/2011-Ch. II dated 26.3.2012, it was decided to Iratify norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, 1281whichever is less: i i Export product Exp. SI.No. Import items Qty. , Qty. allowed 2-Chloropyridine 1 kg I. Alumino Silicate 0.019 kg Catalyst 2. Ethyl Alcohol 2.325 kg (Denatured) ') Methanol 1.410 kg -'. II 4. Caustic Soda 1.400 kg ;,RA may take appi opnate of Norms Committee.

Case NO.:250/5/82-

,ALC4/2015 Party NamePAYAL PETROCHEM PRIVATE LIMITED RLA File :05/24/040/00528/AM15/ Meet No/Date:8/82- ALC4/2015 16092015 Lic NoIDate051 0393339 IDefer Date: 24.02.2015 .•. HO File r01/82/050/00390/AM16/ iDecision : The committee decided to ratify the norms based on the recommendation of :315 iDepartment of 46011 /79/2014-PC-11 dt. 26.8.2015 as per details given below or as applied by the: i 'firm which . I ' ever IS ess:- EXJlort product Oty. Import items Otv.kq Di-Octyl Teraphthalate 1kg 1 I Pure Tere Phthalic Acid 0.400 (DOTP) 2 I 2-Ethyl Hexanol 0.613 IRA may take further action accordingly.

F. No.350111453/2014-PI (Norms) Government of India Udyog Bhawan, New Delhi, the February, 2015 Office Memorandum Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (VoLl) 2009-14 Case of Mis. Globe Trotters Pvt Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182/50/389/AM15/DES-3/343 dated the 18/07114 vide which an application from Mis. Globe Trotters Pvt Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Ampicillin Sodium Sterile+Sulbactam Sodium Sterile (2:1) (Sterile,Crystalline and Apyrogenic). This department has examined the matter and the following comments are furnished under para 4.7 of Hand Book of Procedures (VoLl) 2009-14:- S. No. Import Item Qty. Recommended kg/kg. 1. Sulbactam Sodium Sterile USP Bulk 0.34 kg/kg 2. Ampicillin Triyhydrate IP 0.68 " " Acetonitrile 0.959 " oJ. 4. Diethylamine 0.1667 " 2. This issues with the approval of Director (PI). (Barnali Khastgir) Phone- 23071162 (Shri M.V. Singh, FTDO),

._ _ _ _ __ __ _ ~hh~' ·., __ .• .• A ~ ._ • _ Case No.: \O//82-ALC4120\3 'Party Name:SALlCYLATES & Meet No/Date:3/82- ,CHEMICALS PRlVATE ALC4/20 I3 LIMITED 02.05.20 I3 iStatus:Case IApproved HQ File :01182/0501014681 AM 131 RLA File :0912410401005251 AM 131 Lic.No/Date:0910054981 0802.2013 Decision : In the light of written comments received from Department of Chemicals and IPetrochemicals vide their U.O No. 1401 0/34/20111Ch. II dated 9.5.2013, it was decided lto ratify norms under

Para 4.7 of HBP vi as per details

given below or as applied by the [firm, whichever is less: I Export product Exp. SI.No. Import items Qty. allowed Qty. Methyl Hydroxy 1 kg 1 Para hydroxyl Benzoic Acid 0.989 kg Benzoate 2. Methanol 0.500 kg BP/Methyl Paraben Propyl Hydroxy 1 kg 1. Para Hydroxy Benzoic Acid 0.835 kg Benzoate Propanol 0.472 kg I 2. BP/Propyl II Paraben IRA may take appropriate of Norms Committee.

r

-ICase -No~160/5/82- Party NamePCL OIL iALC4/2015 SOLVENTS LTD., I & Meet - No/Date: 12/82--~Status:Case 1 ALC4/2015 jApproved 18.11.2015 . HO File RLA File Lic.No/Date:0510393132 Defer Date: ;:01/82/050100300/AM161 :05/24/040100389/AM151 11.02.2015 I Decision : Committee considered case as per agenda and decided to ratify norms under para I 1213 '4.7 of HBP as per earlier decision taken by NC in its meeting No.3/82 dated 8.5.2014 or as! !applied by the firm whichever is less. ! I 1 I i Export product Exp. SI.No. Import items Oty. Oty. allowed PVC Plasticizer 1 kg 1. Phthalic Anhydride OAOO kQ 2. 2 Ethylhexanol (Octaonol) 0.700 kg action as per the decision of Norms Committee. .. _. J

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Case No.:49/17/82-ALC4/2013

Party Name:VIVIMED LAB Meet No/Date: 19/82- .L1MITED ALC4/2013 '02.01.2014 Status:Case Approved ..~ .. HQ File :0 1/82/05010091 II AM 141 RLA File :09/2410401002841 AM 14/ ... Lic.No/Date:0910057647 IDefer Date: 20.09.2013 Decision: In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/138/2011-Ch II dated 02.01.2014, it was decided to ratify norms under

Para 4.7 of HBP vi

as per details given below or as applied by the firm, i whichever is less: 1 1144 Export product Exp. SI.No. Import items Qty. allowed Qty. DANTUFF-Z 1 kg 1. 2 CHLORO PYRIDINE 0.502 kg SUSPENSION OR i ZINC PYRITHIO E 2. TU GSTIC ACID 0.029 kg SUSPENSION OR i ZEE SUSPENSION 3. HYDROGE PEROXIDE (H202) 0.150 kg ! , ORZPTO , 4. HEXANE 0.900 kg , i 5. ZINC SULPHATE 0.358 kg ! ! 6. CAUSTIC SODA FLAKES (NAOH) 0.02 kg ! action as per the decision of Norms Committee.

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-~- I Lic.No/Date:0810102781 'Defer Date: i. '25.08.2011 I Decision: Committee considered caseas per agenda and in light of written comments forwardedbY·OePtt-1 of C&PC vide their U.O.No. 14010/4/2012- CH.II dated 05.06.2012 and in consultation with technical I 56 authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as i I' db fi hi h I I

Case NO.:46/31/82-

ALC4/2011 .Party Name: POSY Meet No/Date 10/82- 'PHARMACHEM PVT. LTD. ALC4/2012 05.06.2012 Status:Case Approved File :0 1182/0501008721 AM 121

IRLA File i:08/24/040100084/AM 121 appue )y rrrn w IC ever IS ower:- Export product Exp. SI.No. Import items Qty. Qty. allowed CITRIC ACID 1 kg 1. Citric Acid Anhydrous 1.01kg ANHYDROUS USP/KOSHER RA concerned may take further necessary action as per above decision of NC. i i I j ................ !

F. NO.35011/858/2015-PI (Norms) Government of India Shastri Bhawan, New Delhi, Dated: September 8,2016 Office Memorandum Sub: - Fixation of norms under para 4.7- Application of Mis J.B. Chemicals & Pharmaceuticals Ltd. The undersigned is directed to refer to DGFT U.O. No. 01/82/50/01612/AM-16/DES-3 11753 dated the 02.03.2016 vide which an application from Mis J.B. Chemicals & Pharmaceuticals Ltd was sent to this Department for fixation of norms against export of (1) Difflam Sugar Free Lozenges Flavours Raspberry/Eucalyptus & Menthol/Honey & Lemon/Orange/Double Mint. (2) Difflam AAA Sugar Free Lozenges Flavours/Eucalyptus & Menthol/Honey & Lemon/Black CurrantiBerry. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14: - Product to be Exported Raw materials to be Imported s. Description Quantity s. Description Quantity No No. for 100 lozenges 1. Difflam Sugar Free Lozenges 100 1. Benzydamine 0.306 Flavours Raspberry/Eucalyptus & lozenge Hydrochloride Menthol/Honey & Lemon/Orange/Double Mint (each 2. Cetylpyridinium 0.1356 lozenge contain Benzydamine Chloride Hydrochloride 3.00 mg, Cetylpyridinium Chloride 1.33 mg and 3. Isomalt ST-M 259.186 Isomalt ST-M 2591.86 mg). 2. Difflam AAA Sugar Free Lozenges 100 1. Benzydamine 0.306 Flavours/Eucalyptus & lozenge Hydrochloride Menthol/Honey & Lemon/Black CurrantiBerry(each lozenge contain Benzydamine Hydrochloride 3.00 mg 2. Isomalt ST-M 259.186 and Isomalt ST-M 2591.86 mg). 2. (Raj Kumar) Phone: 23071162 uspi3-pharma@nic.in (Shri M V Singh, FTDO), Udyog Bhawan, New Delhi.

F. NO.35011/774/2015-PI (Norms) Government of India Shastri Bhawan, New Delhi, Dated: July 5, 2016 Office Memorandum Sub: - Fixation of norms - Application of MIs J.B. Chemical & Pharmaceuticals Ltd. The undersigned is directed to refer to DGFT U.O. No. 01/82/050101085/AM- 16/DES-3 11364 dated 21/12/2015 forwarding an application of MIs J.B. Chemical & Pharmaceuticals Ltd. for fixation of norms against export of 3 compositions of Difflam Brand Sugar Free lozenges. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.I) 2009-14:- Product to be Exported Raw materials to be imported s. Description Quantity S.NO Description Quantity in No. gm for 100 lozenges 1. Difflam AAA Sugar Free Lozenges in 100 Benzydamine 0.306 Raspberry! Eucalyptus and Menthol! lozenges 1. hydrochloride Honey & Lemon! Orange!Double Mint 2. Cetylpyridiniu 0.1356 Flavours. Each lozenge contains m Benzydamine Hydrochloride 3.00 mg, Chloride Cetylpyridinium Chloride 1.33 mg and Isomalt ST-M 214.164 Isomalt ST-M 2141.64 mg 3. 2. Difflam AAA Sugar Free Lozenges 100 1. Benzydamine 0.306 Flavours! Eucalyptus & Menthol! lozenges hydrochloride Honey & Lemon! Blackcurrantl Berry. 2. Each lozenge contains Benzydamine Isomalt ST-M 214.164 Hydrochloride 3.00 mg and Isomalt ST- M 2141.64 mg 3. Difflam Sugar Free Lozenges Mint 100 1. Benzydamine 0.306 Fresh Flavours. Each lozenge contains lozenges hydrochloride Benzydamine Hydrochloride 3.00 mg 2. and Isomalt ST-M 2141.64 mg Isomalt ST-M 214.164 2. This issues with the approval of Director (Pharma Industry). (Raj Kumar) Phone: 23071162/Uspi3-Pharma@nic.in Directorate General of Fereign Trade,

F. NO.35011/858/2015-PI (Norms) Government of India Shastri Bhawan, New Delhi, Dated: September 8,2016 Office Memorandum Sub: - Fixation of norms under para 4.7- Application of Mis J.B. Chemicals & Pharmaceuticals Ltd. The undersigned is directed to refer to DGFT U.O. No. 01/82/50101562/AM-16/DES-3 11700 dated the 19.02.2016 vide which an application from MIs J.B. Chemicals & Pharmaceuticals Ltd was sent to this Department for fixation of norms against export of various lozenges under brand name 5eptolete containing Cetylpyridinium Chloride as API and Isomalt 5T -M as excipient. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14: - Product to be Exported Raw materials to be Imported S.No Description Quantity Description Quantity for 100 lozenges 1. 5eptolete Lozenges, 100 Cetylpyridinium 0.102gm 5eptolete Extra Lozenges, lozenge Chloride 5eptolete. Ultra Lozenges, 5eptolete Omni Lozenges, 5eptolete Total Lozenges, 5eptolete Duo Lozenges and 5eptabene Lozenges (each Isomalt ST-M 258.055 gm lozenge contain 1 mg Cetylpyridinium chloride & 2580.550 mg Isomalt ST-M) 2. (Raj Kumar) Phone: 23071162 Uspi3-Pharma@nic.in (Shri M V Singh, FTDO), Udyog Bhawan, New Delhi.

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F. NO.35011/767/2015-PI (Norms) Government of India 19- Udyog Shawan, New Delhi, Dated: June, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Sook of Procedures (Vol.l) 2009-14 Case

of MIs Venus Remedies Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1054/AM-16/DES- 3/1555 dated the 14/1/16 vide which application from M/s Venus Remedies Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Cefoperazone & Sulbactam for injection 1.0gm. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S.No. Export item Import item Norms for 1No. Vial 1 Cefoperazone & Cefoperazone Sodium 0.541gm Sulbactam for injection Sterile 1.0gm 2 Cefoperazone & Cefoperazone Sodium 1.082gm Sulbactam for injection Sterile 2.0gm 2. (Rajkumar) PH:- 23071162

F. NO.35011/789/2015-PI (Norms) Government of India Shastri Bhawan, New Delhi, Dated: July 18, 2016 Office Memorandum Sub: - Fixation of norms - Application of Mis Jodas Expoim Pvt. Ltd., New Delhi. The undersigned is directed to refer to DGFT U.O. No. 01/82/050101294/AM-16/DES- 311491 dated 12/01/2016 forwarding an application of Mis Jodas Expoim Pvt. Ltd. for fixation of norms against export of Temozolomide Capsules in 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg strengths and (ii) Carboplatin Injections in 50 mg/5ml vial, 100 mg/10 ml vial, 150 mg/15 ml vial, 450 mg/45 ml vial and 600 mg/60 ml vial. This department has examined the matter and the following norms are furnished: - (A) Export Product Temozolomide Capsules:

Strength 5 mg 20 mg 100 mg 140 mg 180 mg 250 mg Quantity of Temozolomide 5.100 20.400 102.000 142.800 183.600 255.000 for 1000 Capsules gm gm gm gm gm gm (B) Export Product Carboplatin Injections Strength 50 mgl 5 ml 100mg/10 150 mgl 15 450 mgl 45 600 mgl 60 vial ml vial ml vial ml vial ml vial Quantity of 5.50 gm 11.00 gm 15.75 gm 47.25 gm 63.00 gm Carboplatin for 100 vials for Injection 2. This issues with the approval of Director (Pharma Industry). (Raj Kumar) Phone: 23071162/Uspi3-Pharma@nic.in (Shri M V Singh, FTDO), Udyog Bhawan, New Delhi.

b F. NO.3S011108/2011-PI (Norms) Government of India Udyog Bhawan, New Delhi, the 28th November, 201 I. Office Memorandum Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case of Mis LUPIN LTD. The undersigned is directed to refer to DGFT u.o.No. 01l821S01140SIAM111DES-31l323 dated the 07/01111 vide which an application from Mis LUPIN LTD was sent to this Department for fixation of norms under para: 4.7 for the export of STERILE CEFTRIAXONESODIUM 250 MG/500 MG/1GM/2GM/l0 MG INJECTION. This department has examined the matter and the following comments are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- Qty. Recommended kg/kg. S. No. Import Item

1. ETHYL ACETATE 2.181 @v V
2. METHYLENE CHLORIDE 2.00
3. SODIUM HYDROSULPHITE 0.0049 QDV' 7 AMINO CEPHALOSPORANIC ACID 0.668 2,5,DIHYDRO-6-HYDROXY-3-MERCAPTO-2-METHYL-5-0XO- 0)\VS· l,2,4-TRIAZENE 0.360
4. BORON TRIFLUORIDE GAS 0.611 CV
5. ACETONITRILE 2.60 ~ )~. ACETONE 11.50 ~. ACTIVATED CARBON -W 0.100 Q V~ TETRA HYDROFURAN 1.23
6. FORMIC ACID 3.158
7. HEXAMETHYL DISILAZANE 0.540 --
8. TRIETHYL AMINE - (i) 0.514
9. PHOSPHOROUS PENTACHLORIDE 0.474

r>. 15. ISOPROPYL ALCOHOL

@ 0.400 I" 16. THIOUREA 0.180 ETHYLENE DIAMI NE TETRA ACETIC ACID DISODIUM 17. SALT{E.D.T.A DI SODIUM) 0.040 18. SODIUM BICARBONATE 0.511 19. TRIM ETHYL CHLOROSILANE 0.079 20. SODIUM 2-ETHYL HEXANOATE 0.684 4-BROMO-2-METHOXYIMINO-3-0XO BUTYRIC ACID (BROMO 21. ACID) 0.485 Conditons: - (1) issue of Non-Infringement may be examined by DFGT in line with the policy. (2) Norms for Injections may be considered as per SION A-205 and A-206 respectively. This issues with the approval of Deputy Director General. (N.N.Ahuja) Section Officer PI-NORMS (Shri Shyam Lal, FTDO), Udyog Bhawan, New Delhi.

'Case No.:27/35/82- ALC4/2011 Party NameSHREE BANKEY BEHARI LAL BOARD MILLS RLA File •05/24/040100224/AM 121 Meet NolDate.35/82- ALC4/2011 29.11.2011 Lie.No/Date.051 0304814 10.10.2011 Status:Case I' Approved 'HQ File .01/82/0501009541 AM 121 rD~c'isi~n: Committee considered case as per agenda and in light of written comments forwarded 'by' iDepartment of C&PC vide their U.O. No. 14010/88/2004-Ch. III dated 27.10.2008 and in consultation 148 iwith technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per .details below or as applied by firm whichever is lower- Export product Exp. Qty SINo. Import items Qty. allowed Thymol (Purity 98.5% Min.) 1 Kg. 1. Meta Cresol 0.785 kg RA concerned may take further necessary action as per above decision of NC. I Ij

iParty Name:CONTINENT AL .Meet No/Date: 14/82- Status:Approved CHEMICALS ALC4/2013 24.10.2013 HQ File !:O 118210501007431 AM 141 ·RLA File 1:08/24/0401000831 AM 141 Lic.No/Date:081 0 121749 .Defer ,06.06.2013 Date:21 I 1.2013 iDecision : In the light of written comments received from Department of Chemicals and 'Petrochemicals vide their U.O No. 14010/15/2012-Ch II dated 17.06.2013, it was decided to .ratifv norms under

Para 4.7 of HBP vi

as per details given below or as applied by the firm, whichever is less: 145 I . Export product Exp. SLNo. Import items Otv. allowed ! ! Qty. I 4,4 DIAMINO 1. 0.611 kg I Acetanilide II SULPHANILIDE (DASA) II 2. Para Nitro Aniline 0.605 kg 3. Caustic Soda Flakes 0.482 kg , 4. Soda Ash 0.370 kg Ii ; iA may take appropriate action as per the decision of Norms Committee.

F. No.350 111500/20 13-PI (Norms) Government of India Udyog Bhawan, New Delhi, the 21st October, 2013 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (VoLl) 2009-14 Case of Mis

Neuland Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182/501681 AM14/DES-31190 dated the 17/05113 vide which representation from Mis. Neuland Labs Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Levofloxacin Hemihydrate. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (VoLl) 2009-14:- S. No. Import Item Qty. Recommended kg/kg. (-)9,10-difluoro-2,3-dihydro-3-methyl-7 -oxo-7H- pyrido[ 1,2,3-de-l ,4-benzoxazine-6-carboxylic acid] 1. (Levofloxacin Q-acid) 0.8571 2. Pyridine 1.06 3. Methanol l.06 4. Methylene chloride 1.70 5. Isopropyl Alcohol 0.85 6. N Methyl Piperazine 0.432 2. This issues with the approval of Director (Cost). (Raj Kumar) PI-Norms (Shri R.C. Meena, Dy. DGFT), Udyog Bhawan, New Delhi.

F. NO.3S0111648/2013-PI (Norms) Government of India Ministry of Chemical & Fertilizers Department of Pharmaceuticals New Delhi, the Udyog Bhawan, November, 2014 Office Memorandum Subject:

• Fixation of norms under para 4.7 of Hand Book of Procedures (VoU) 2009-14 Case of Mis Ciron Drugs & Pharma Pvt Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/821S0/447/AM- 14/DES-31S78 dated the 30109113 vide which application from Mis. Ciron Drugs & Pharma Pvt Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Can-C Eye Drops. This department has examined the matter and the following norms are furnished under

para 4.7 of Hand

Book of Procedures (VoU) 2009-14:- S.No. Import Item Qty. Recommended. 1.N-Acetyl-Carnosine 0.OS1gmlSml vial This issues with the approval of Director (Cost). (Barnali Khastgir) Under Secretary to the Government of India Directorate General of Foreign Trade, Department of Commerce, Udyog Bhawan, New Delhi

I '-Ilcase NO.:8/34/82-_A_LC4/2_0_1_0IParty Na~e:RASULA-- rMeet NO/Date~421s2~- IPHARMACEUTICALS& FINE ALC4/2010 CHEMICALS 18.01.2011 I IHQ File ,RLA File Lic.No/Date:0910044229 :01/82/050/01014/ AM 11/ ':09/24/040/00293/ AM11/ 11.11.2010 Decision .-Committee considered c~se as per agenda ~nd in light of written comments for~arded byl Status:Case IApproved I iDepartment of C&PC vide their U.O. No.14010/87/2003/Ch.11I dated 20.09.2005 and in consultation with technical authority present in meeting, decided to ratify norms under

para 4.7 of HBP as per details

Ibelow or as applied by firm whichever is lower:- I Export product Export SI.No. Import items Qty. I Qty. allowed I Propyl Paraben 1 Kg. 1. Parahydroxy Benzoic Acid 0.714 kg I Sodium 2. N-propanol 0.310 kg . . IRA concerned may take further necessary action as per above decision of NC.

F. NO.350111298/2015-PI (Norms) Government of India Udyog Bhawan, New Delhi, the October, 2015 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of

Mis Jodas Expoim Pvt Ltd. The undersigned is directed to refer to DGFT U.O.No. 01l82/5011378/AM-16/DES-3114 dated the 01105115 vide which application from Mis. Jodas Expoim Pvt Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Vancomycin HclSOOmg vial and Igrrn vial. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (VoU) 2009-14:- S. No. Import Item Qty. Recommended. 1.0764 gml1gm vial 1. Vancomycin Hcl (Non Sterile) And 0.5382 gm/500mg vial (Raj Kumar) Phone:23071162

F. No.35011/825/2015-PI (Norms) Government of India Dated: 1 June, 2016 Office Memorandum

Subject: - Fixation of norms un

para 4.7 of Hand Book of Procedures (Vol./) 2009-14

Case of MIs A . Ife~s Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/~0092/AM- 17/DES-3/94 dated the 11/5/16 vide which application from MIs Ami u.teSciences Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Diacerein. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S.No. Import item Norms Recommended for 1kg Export 1 Aloe emodin 95% 1.05kg 2. (Rajkumar) PH:- 23071162

F. No.35011/781/2015-PI (Norms) Government of India Dated: 26 April, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14

Case of MIs Sun Pharmaceutical Industries Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1295/AM- 16/DES-3/1237 dated the 15/12/15 vide which application from Mis Sun Pharmaceutical Industries Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Clarithromycin Carbomer Granules 43.75%/44%. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14:- DGFT is advised to call following details from the firm viz:-

1. Copy of valid DML for above export product.

Copy of Master-Batch formula duly certified by Q.C. incharge. 2. (Rajkumar) PH:- 23071162

F. NO.35011/781/2015-PI (Norms) Government of India Dated: 26 April, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (VoLl) 2009-14

Case of MIs Sun Pharmaceutical Industries Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1438/AM- 16/DES-3/1407 dated the 11/1116 vide which application from MIs Sun Pharmaceutical Industries Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Clarithromycin Carbomer Granules 27.5/28%. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- DGFT is advised to call following details from the firm viz:-

1. Copy of valid DML for above export product.

Copy of Master-Batch formula duly certified by a.c. incharge. 2. (Rajkumar) PH:- 23071162 (Shri MV. Singh, FTDO),

F. No.35011/119/2016-PI (Norms) Government of India Dated: July, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14

Case of MIs AnutYPha~d. The undersigned is directed to refer to DGFT U.O.No. 01/82/50191IAM-17/DES- 31128 dated the 23/5116 vide which application from Mis Anuh Ph~·Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Beta Sodium Phosphate(Betamethasone sodium phosphate). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S.No. Import item Norms Recommended for 1kg Export 1 Betamethasone 0.78kg 2. (Rajkumar) PH:- 23071162 (Shri MV. Singh, FTDO),

F. NO.3S0111210/2014-PI (Norms) Government of India Udyog Bhawan, New Delhi, the October, 2014 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of

Mis Anuh Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. Ol/82IS011090/AM-l4/DES- 311404 dated the 31103114 vide which application from Mis. Anuh Pharma Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Erythromycin 11, 12 Carbo~te. This department has examined the matter and the following norms are furnished ••..... under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S. No. Import Item Qty. Recommended kg/kg. 1. Erythromycin Thiocyanate 1.22kg A/kg This issues with the approval of Director (Cost). (Barnali Khastgir)

F. NO.35011/139/2016-PI (Norms) Government of India Dated: August, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14

Case of MIs Suven Life Sciences Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/260/AM-17/DES- 31206 dated the 4/7/16 vide which application from Mis Suven Life Sciences Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of 2-Chloro Thioxanthone (CTX). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S.No. Import item Norms Recommended for 1kg Export 1 4-chloro thiophenol 1.00kg 2 2-chloro benzonitrile 0.94kg 3 Dimethyl sulfoxide 1.54kg 4 Poly phosphoric acid 3.517kg 2. (Rajkumar) PH:- 23071162 (Shri MV. Singh, FTDO), Udyog Bhawan, New Delhi.

F. NO.35011/766/2015-PI (Norms) Government of India Dated: 26 April,2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (VoLl) 2009-14

Case of MIs Zim Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1388/AM- 16/DES-3/1537 dated the 14/1/16 vide which application from MIs Zim Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Nieardipine Hel SR Pellets 50mg. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (VoLl) 2009- 14:- S.No. Import Item Norms Recommended for 1kg Export 1 Nicardipine HcI 0.2196kg SR Pellets 2. (Rajkumar) PH:- 23071162 (Shri MV. Singh, FTDO),

F. No.350111478/2013-PI (Norms) Government of India Department of Pharmaceuticals Udyog Bhawan, New Delhi, the August, 2014 Office Memorandum Subject:- Fixation of norms under para 4.7 of Hand Book of Procedures (VoLl) 2009-14 Case of Mis Gopaldas Visram & Co. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01l82/50/501AM- 141DES-3/9 dated the 22/04114 vide which application from Mis. Gopaldas Visram & Co. Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Funbact A Cream. This department has examined the matter and it is noted that the reply received from the firm does not related to the present case under referacne, Import item-Betamethasone Dipropinate USP. This issues with the approval of Director (Cost). (Raj Kumar) Under Secretary to the Government of India PI-Norms Directorate General of Foreign Trade, Department of Commerce,

Ii,e NO.,26/28/82-ALC4/2010 Iparty Name:NEW ALLIANCE -r I Meet NO/Date:36/82- IStatus:Case IDYE-CHEM PVT. LTD., ALC4/2010 IAPproved I 07.12.2010 I HQFile IRLA File lic.No/Date:0310594864 I :01/82/050/00908/AM11/ :03/95/040/00526/AM11/ 01.10.2010 I IDecision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/83/2010/Ch.1I dated 29.11.2010 and in consultation with 89 technical authority present in meeting, decided to ratify norms under

para 4.7 of HBP as per details

below or as applied by firm whichever is lower:- I Export product Exp. SI.No. Import items Qty. allowed Qty. Zinc Diammonium EDTA- 1 kg 1. Ethylene Diamine Tetra Acetic Acid 0.422 kg I liquid Zinc content 9%( (EOTA) +1) I IRA concerned may take further necessary action as per above decision of NC.

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ilcase NO.:28/28/82---·--!PartYN;':;;-e:NEW ALLIANCE-[Meet No/Oate:36/82- [status:case I i :ALC4/2010 ;OYE-CHEMPVT. LTD., iALC4/2010 'l'Approved ! I 'I I l I I i : !07.12.2010! I !HQ File -------------fRlA File ["lk.No/Oate:0310594869 ;-1----I I 1:01/82/050/00910/ AMll/ !:03/95/040/00527 / AMll/ 101.10.2010 ; 'I' !Oecision : Committee considered case as per agenda and in light of written comments forwarded by / I'oepartment of C&PC vide their u.o. No.14010/83/2010/Ch.l1 dated 29.11.2010 and in consultation ,I V' with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per: 91 [details below or as applied by firm whichever is lower:- I I Export product Exp. Si.No. Import items Qty. Qty. allowed Copper Oiammonium 1 kg 1. Ethylene Oiamine Tetra Acetic Acid 0.436 kg EOTA-Liquid (EOTA) Copper content 9% (+1) , IRA concerned may take further necessary action as per above decision of NC. -----------~

-Ie,,, No.,44/J4/82- ALe4120I0 r;;;;-rty N;m,A v A MICALS M", No/D.,,,, 1182- , I,PYT.LTD., ~ :ALC4/2012 .(' 104.10.2012 IHQ File / ~ IRLA File ,Lic.No/Date:0310570074 IDefer Date: 1:01/82/050/0.e<06/.~~ II :03/94/040100043/AMIII ,19.04.2010 fn-;cision -: In the light of ~ritte;-~omments received from Department of Chemicals and 'p h . I 'd hei UON 14010/157/2011 Ch II d d 1012012 . decid d Status:Case Approved I etroc erruca S VI e t err o.

ate .. , It was eCI e to ratify norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, Iwhichever is less: I Export Product Export S.No Import Product Quantity Quantity Allowed I EDTA Ferric Sodium (Fe I kg I. Ethylene Diamine 0.730 kg I content 13%±0.5%) Tetra Acetic Acid (EDTA) . . IRA may take appropriate of Norms Committee .

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~ [Case No.:8/14/82-ALC4!2012

/ ..~ Party Name:MICRO NKS LTD. Meet No/Oate:20/82- ALC4/2012 / 'Status.Case 'Approved 20.09.2012 :HQ File :01/82/050/00385/A -1131 RLA File :03/95/04 1001361 AM 131 Lic.No/Oate:0310695836 -:O~ier Oate-:-i 23.05.2012 ~Dec~i~~: In the light of written comments received from Petrochel:;'ic;IOfvi;ion of: 'Department of Chemicals and Petrochemicals vide their OM No. 46011/20(A)/2010-PCll: idated 30.8.2012, it was decided to ratify norms under Para 4.7 of HBP v I as per details given: .below or as applied by the firm, whichever is less: 231 : Export product Exp. Oty. SI. No. Import items Oty. allowed Polyester Acrylate 1 kg 1. Tetra Chlorophthalic Anhydride 0.1250 kg (60% Resin content in tri I: , methylol propane triacrylate) 2. Adipic acid 0.0440 kg 3. Iso phthalic acid o 1880 kg 4. Pentaeryth ritol 0.0330 kg 5. Neo pentyl glycol 0.1800 kg 6. Propylene glycol 0.0530 kg ; 7. Phthalic anhydride 0.0460 kg i 8. Tri methylol propane triacrylate 0.4020 kg ; RA may take appro riate action as er the decision of orms Committee. p p

hosphoric Acid 1.00 kg ,--r- -

AM10/ I .- ---

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,Meet No/Date:5/S2- I ALC4/2010 IStatus:Case 104.05.2010 IAPproved ILi~.N~/Date:0310564712 -r-- 115.03.2010 I I Icase No.:31 S/S2-ALC4/2010 INDUSTRIES PVT.LT 1 I r- - ---- -,.---- ,--

HQFile IRLA File :01/S2/050/00065/ AM 11/ 1:03/95/040/00S20/ I Decision : Committee considered case as per agend Department of C&PC vide their U.O. No.14010/120 1 139 with technical authority present in meeting, deci details below or as applied by firm whichever is lowe I I Export product Exp. SI.No. I I I Qty. I Butylated Hydroxy 1 Kg. 1. H Anisole 2. T 3. P 4. H I RA concerned may take further necessary action as p

--

/ Party Name:YASHO D. a and in light of written comments forwarded by /2007/Ch.1II dated 07.07 .200S and in consultation ded to ratify norms under

para 4.7 of HBP as per

r:- 1.247 kg mport items Qty. allowed ydroquinone 0.S39 kg ertiary Butanol exane 1.00 kg er above decision of NC.

r--rr----- .- I ICase No.:7/9/82-ALC412012 I --. rMeet No/Date: 14/82- IALC4/2012 131.07.2012 IRLA File _. -:Uc.No-/D-a-te-:0-3-10694105 ,:03/95/040/000 13/AM 13/ 110.05.2012 r----

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IDefer Date: IParty N;-m~RELlANCE

INDUSTRIES LTD. Status:Case Approved I HQ File :0 I/82/050/00252/ AM 13/ Decision: In the light of written comments received from Department of Chemicals and Petrochemicals vide their OM No. 46011/36/2012-PC II dated 23.7.2012, it was decided to 1180 ratify norms under Para 4.7 ofHBP vI as per details given below or as applied by the firm, , whichever is less: 1 II~----~------------~-~--~----------~~----~ Export product Exp. SI.No. Import items Qty. I Qt . allowed Methyl Tertiary Butyl Ether I MT I. Na htha 0.908 MT I (MTBE) 1-2-.--+-M--'e~th-an-o-I-----+-0.-34-5-M-T--l IRA may take appropriate action as per the decision of Norms Committee.

F. NO.35011130/2014-PI (Norms) Government of India New Delhi, the Udyog Bhawan, October, 2014 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s

Glenmark Generics Ltd. The undersigned is directed to refer to DGFT U.O.No. 01l82/50/769/AM-14/DES-3/926 dated the 22111/13 vide which application from M/s. Glenmark Generics Ltd was sent to this Department for fixation of norms under para: 4.7 for the export ofPerindoprii Erbumins. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- Qty. Recommended kg/kg. S. No. Import Item .-.. 1. 2(S)-Indoline-2-Carboxylic Acid 0 0.947 2. Methanol , -{})~ 1.43 3. Toluene

U 3.22 ~ 4. Methylene Chloride/Methylene Dichloride/MDC -~' 15.19 5. L-Norvaline «: 1.423 6. Acetonitrile W 3.57 ,~ 7. Sodium Pyruvate t21 1.42 This issues with the a roval of Direcwr Cost . pp ( ) (Barnali Khastgir)

I r~S~~;O:/i/15/82- ---Ii~du~~~~~~L TD:--- r~472ote:22/82- II!t:~~~~se I i I 120_02_2014 I 1:~~~50/00774/AM:----:~;~~~iO/00;3~-~:~-14/ :~~~i-~-~-~-t3-te-:0--3-10-752058IDefer Date: I rDeci-~ion: In-th-e light of written com~ents -~ecei~ed f;:;m -Department of Chemicals and I I Petrochemicals vide their U.O No. 14010/95/2011/Ch II dated 26.02.2014, it was decided to ratify norms under

Para 4.7 of HBP vi

as per details given below or as applied by the firm, 1951whichever is less: I II~------------~-----'----~---------------,----------, i Export Product Export S.No Import Product Quantity Allowed 1~~~~~ ~_Q~u_a_nt_it~y-+ -r ~ ~ I ISOEUGENOL 1 kg 1. CLOVELEAFOIL 1.51 kg ~2-. --~R~U~T~H~EN~I~U~M~(~III~)~2,74--------+-0-.0-0-1~k~g-------1 PENTANEDIONATE( RUTHENIUM ACETYLACETONA TE)

lease No.:24/4/82-ALC4/2011 'Party Name AVA i CHEMICALS PVT.LTD, .Meet No/Date:8/82- ALC4/2011 '24.05.2011 .. . [Status.Case IApproved ! HQ File ::01 182/050100075/AM 121 IRLA File L03/94/040100736/AM 111 Lic.No/Date:0310606822 I 16.12.2010 (".•..~".•~.'''•.'' ..'' ' •.•••.n. •.•.•.•"••n•.""~........ . .....n. .n,. .•••...,.,, •.• ... __ _ , •.,, .•• .••""~"" ••. Decision : Committee considered case as per agenda and in light of written comments forwarded by [Oepartrnent of C&PC vide their U.O. No.14010/110/2007/Ch.11 dated 14.06.2010 and in consultation 47 iwith technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per Idetails below or as applied by firm whichever is lower:- !.-----------------------,-----~--,-~--,-------------------,-----------~ i Export Product Export Oty. SI. No. Import items Oty. allowed i~----------------------+-------~1-----1------------------1_----------~ EDTA Tetra Ammonium- Liquid 1 KG. 1. Ethylene Diamine Tetra 0.341 kg Assay min. 40% Acetic Acid (EDTA) I IRA concerned may take further necessary action as per above decision of NG.

,- iCase No.:S9/24/82-ALC4/2012 'Party Name:AVA CHEMICALS Meet No/Date:25/82- PVTL TO" ALC4/20 12 29,11.2012 rSt;tu~~CaseI 'Approved HQ File RLA File Lie, 'o/Date:OJ I0709879 Defer Date: :OIl82105010086J/AMIJI :OJ/94/040100447/AMIJI 21.09,2012 , j' 'Decision: In the light of written comments received from Department o{Ch~'I~iZ~I~--a~d 176 iPetrochemicals vide their U.O No. 140101157/2011-Ch. II dated 9.4.2012, it was decided to [ratify norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, jwhichever is less: I Export Product Export S.No Import Product Quantity I Quantity allowed I Disodium I kg I. Ethylene Diamine Tetra 0.690 kg Magnesium EDTA Acetic Acid (EDTA) , I (Magnesium content I 6%+1-0,5) IRA may take appropriate of Norms Committee. -.- ...- -, ~-

I . Meet o/Date:3/82- ALC4/2014 08.05.2014 Status.Case Approved

Case No.:1)1)/3/82-ALC4/2014

Party NarneAv A CHEMICALS PVT.L TD. HQ File 01/82/050/00 I031AM I 51 RLA File 03/94/0401009521 AM 141 Lic.NolDate0310769004 Defer Date: 04.02.2014 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/157/2011-Ch. II dated 29.05.2014, it was decided to .ratlfv norms under

Para 4.7 of HBP vl as per details

given below or as applied by the firm, :3I 5 whichever is less: Export product Export S.No. Import items Quantity I' Quantity Allowed DISODJUM MANGANESE EDTA I kg I Ethylene Diamine Tetra 0.690 kg I: (Manganese Content 12.5% - - 0.5) Acetic Acid I' action as per the decision of Norms Committee.

HQ File 01/82/05010 1216/AM 151 RLA File 03/94/040100436/AM 151 Meet No/Date: 13/82- ALC4/2014 19.12.2014 Lie. o/Dale031 0788106 Defer Dale: 19.08.2014 Status.Approved

Case NO.:213/13/82-

ALC4/2014 Party Name.A VA CHEMICALS PVTLTD. Decision: In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/157/2011/Ch II dated 25.10.2014, it was decided to r.itify norms under Para 4.7 31 of HBPv1 as per details given below or as applied by the firm, whichever is less: Export Product Export S.No Import Product Quantity Quantity Allowed DISODIUM ZINC EDTA 1 kg 1. ETHYLENE DIAMINE 0.690 kg Content 15% (+1- 0.5%) TETRA ACETIC ACID RA may take appropnate action as per the decision of Norms Committee.

Case No.:S6/23/82-

ALC4/2013 Party Name:AYA CHEMICALS PYT.L TO .. IIQ File 01/82/050/0 I 103/AM 14/ RLA File 03/94/040/00822/ AM 14/ Meet No/Date: 1/82- ALC4/2014 10042014 Lie. io/Date:0310765132 Defer Date: 08.01.2014 Status:Case Approved Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/157/2011-Ch II dated 22.04.2013, it was decided to 2221ratify norms under

Para 4.7 of HBP v l

as per details given below or as applied by the firm, i iwhichever is less: Export product Exp. Qty. SI.No. Import items Qty. allowed lkg 1 Ethylene Dianune Tetra 0.750 kg EDTA Tetra Sodium Aceuc ACid action as per the decision of Norms Committee.

Case No.:212113/82- ALC4/2014 Party ame:A VA CHEMICALS PVT.L TO .. Meet No/Date: 13/82- ALC4/2014 19.12.2014 Status:Approved Ir""-' .---. ;HQ File :01182/0501012 ISIAM I51 ~. .- RLA File 03/94/040100437/AM I51 •.. Lie. No/Date:03 10788 I 08 Defer Date 19.08.2014 Decision: In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/157/2011/Ch II dated 9.12.2013, it was decided to ratify norms under

Para 4.7 of

30 HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export S.No Import Product Quantity Quantity Allowed COPPER EDT A . Cu Content 1 kg 1. ETHYLENE DIAMINE 0.719 kg I 14%(+1-1) TETRA ACETIC ACID I: !RA may take appropriate action as per the decision of Norms Committee.

ICase No.: 15120/82- rmO:YASHO Meet NolDate:22/82- Status:Case ALC4/2013 TRlES PYT.L TO. ALC4/2013 Approved 20.02.2014 I HQ File IRLA File Lic.No/Date:0310755428 Defer Date: :01/82/05010100 I/AM 14/ :03/95/0401006021 AM 141 25.10.2013 Decision: In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011/Ch II dated 12.06.2013, it was decided to ratify norms under

Para 4.7 of HBP vi

as per details given below or as applied by the firm, 202 whichever is less: Export Product Export S.No Import Product Quantity Allowed Quantity BUTYLA TED HYDROXY 1 kg 1. HYDROQUINONE 1.247 kg ANISOLE (BHA) 2. TERTIARY BUTANOL 0.839 kg 3. PHOSPHORIC ACID 1.00 kg 4. HEXANE 1.00 kg

\ftni~u'~ or(·ht:lni~.:~t!8.: F~riili/"-~r:,, !k'partl1ll'(l[ o l Ph.innuc •...uticul-. ~!lJl~""'. knwr:lnduP,J xuhicct:

• lix.uior: ul' n.mu-. uud •...r 1'~1r;1~. 7 ,d' Hand !i(),);'" II!' l'rocc.lurc-, (',)1.1, 2iIW)-I.+ Ca:-;L' l'i' \1 ~ illJUl'll RL':lll'JjL'~Ltd. I he und •...r·,jgnc',! i,.ditc •...lI:d Ll.'refer i1.1 [X; I' r ['.().,,,. II is:: 50203:
  \ f -I oD [·:s-.~:~-u d;llcd lhe -'().'()(i .,:' \ ilk \ IIich appl ic.u i •.in (rum \ L:-.. IndllL'l
  Rented i•... :, l.id 'o ;1:-.sent It J [ft is Dcpartm ent tor fixuriou o l norms under para: -J.. 7 It)!' th....l'\pun tit' Lntun oprust Ophthalmic Solution. This department has c.~1l11inL'J the matter and the.: I~dll)\'illg norms arc furnished under pura -L7 lll' Hand Blhlk of Procedures (VII!.I) 20(jt)-I-L- . SL 'l~'mon -(;;'~mllliity I It1PllL~- dC:5C;:iptilll-i -- ..-.- .-. -~l)rnlS R~if1mlt:;;J~'lj ..-., L-'--' .~~criE[ion- L--. .. _ . i l.aranoprcst .._!. l.J.lZ~~!!bt .___ l)_~~) ~~g 2:5.0!1 \ ia! . I. !()pbthalmic') l:ye drop hottk! I.OIJlllmbcrsfureachvial , Solution. ()J)())~il or ; t Packinu material i 125 micrograms per r- .'. l';-~'eJrn~) ~ap; (p-;-ckingi i 2.5 rnl ~ nut.:riai t_.__ .__. . i j

Eye drop . insert i J..eacking material) L- ~ ~ _

• .. -. I.OJ numbers lor each vial .-...,.,..-~--.-. ! i.o: nurnhers t;reac~-~~l 1 _±' (~ Under Secretary to the Government of Indill Phone:2307116:! / .- Directorate General of Foreign Trade. Department of Commerce. (Shri M.V. Singh, f-rDO). Udyog Bhawan.New Delhi

I Case No.,14/46/82-ALC4/2009

Frty Name,YASHO Meet NO/Date:7/82- Status:Case ALC4/2010 NDUSTRIES PVT.LTD. 18.05.2010 Approved

I HQFile IRLA File Lic.No/Date:0310550397 I :01/82/050/00990/ AM10/ 1:03/95/040/00578/ AM10/ 11.12.2009

Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/46/2009/Ch.1I dated 17.05.2010 and in consultation with 84 technical authority present in meeting, decided to ratify norms under

para 4.7 of HBP as per details

below or as applied by firm whichever is lower:- Export product EXp. SI.No. Import items Qty. allowed Qty. Ascorbyl Palmitate 1 Kg. 1. Ascorbic Acid 0.500 kg 2. Palmitic Acid 0.727 kg RA concerned may take further necessary action as per above decision of NC.

I

Case No.mIlS/82-ALC412013

Party Name:Y ASHO Meet No/Date: \8/82- Status:Case INDUSTRIES PYT.L TD. ALC4/2013 Approved \9.12.2013 I

--/Lic.No/Date:0310749089 HQ File RLA File Defer Date: :01/82/0501007841 AM 141 :03/9510401004781 AM 141 11.09.2013 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011-Ch II dated 26.12.2013, it was decided to ratify norms under

Para 4.7 of HBP vi

as per details given below or as applied by the firm, whichever is less: 244 Export product Exp. SI.No. Import items Qty. allowed Qty. OCTYLATED 1 kg 1. DIPHENYLAMINE 0.405 kg DIPHENYLAMINE ( 2. DI-ISOBUTYLENE 0.620 kg OCD FLAKES 1 POWDER) 3. The role of Activated Clay ACTIY ATED CLAY not known and so not recommended RA may take appropriate action as per the decision of Norms Committee.

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1~-- g-o/ ._-- I MIS Salvi Chemical Industries Ltd Case No.8-244 Norms Committee Meeting No.22/AM 12 I F.No.01/82/162/00026/AM 1OIDES-III Meeting Oate30082011 I RA F.No.03/95/040/01366/AM-06 Adv lie.No 0310368651 dated 2402.2006 I Committee considered case as per agenda and in light of production and consumption data certified by Central Excise Authority and in consultation with technical authority present in meeting, decided to ratify norms for regularization purpose as per details below or as applied by the firm whichever is lower:- Export product Exp. SI.No. I Import items Oty allowed Oty. Ferrous Fumarate BP -l' Kg 1 Fumaric Acid (Technical 0.876 kg T- Grade) Ferrous Sulphate 247 kg 3. I Soda Ash 0.065 kg 1--- 1. I Fumaric Acid (Technical 0.885 kg ,lierrous Fumarate USP 1 kg Grade) 2. Ferrous Sulphate 2.52 kg kg 3. Soda Ash 0.015 kg RA concerned may take further necessary action as per above decision of NG.

.Case No.: 146/14/82- ;ALC4120I3 Party Name:MACLEODS .Meet No/Date:23/82- PHARMACEUTICALS LTD.ALC4120 13 .Sta tus: Case .Approved 06.03.2014 rHQFil~'--'-'-------'--------iLA-File-'------ .----- ---- :Li~j~-;JD-~t'~:0310-7-47495---'D~f~I~-D;t~:--- :OI/82/05010073I1AM 141 ':03/95/040100429IAM 14/ .29.08.2013 .Decision : In the light of written comments received from Department of Pharmaceuticals vide; -their OM No. 350111777/2013-Pl(Norms) dated 04.03.2014, it was decided to ratify norms under ipara 4.7 of HBP v I as per details given below or as applied by the firm, whichever is less: . ,83 ' Export product Exp. SI. No. Import items Qty. allowed Qty. kg/kg LEVOFLOXACIN 500MG Kg 1. (S) -9, IO-DIFLUORO-3- 492.8 mg/ TABLETS METHYL-7-0XO- 500 mg 2JDIHYDRO-7-H- Tablets PYRlDO( J ,2J-DE)-I,4- BENZOXAZINE-6-
CARBOXYLIC ACID ETHYL ESTER 'A may takeappropriate.action as per.thedecision.of.Norms Committee. __ _ __. , ...--....~-.---------.--------.-.....-----.•...-.---- --" ..----.-----_ ..---.- ..-- --." -------- •..-- - ---- ..•- ..__ ."- - ..-....------.-.- ------; --------------~-.--_.--

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Government of India Ministry of Chemicals and Fertilizers Department of Chemicals and Petrochemicals Subject: Advance Authorization application from MIs. AMI organics Pvt. Ltd.. for the import of raw material against the export of 3,4-HYDROXY 5-NITRO BENZALDEHYDE- 99% MIN. (Advance Authorization No. 521004339 dated 5.12.2015) Ref UO. No. 01/82/050/525/AM16/DES-1I1/600 dated 14.7.2015 MIs. AMI organics Pvt. Ltd. have submitted present application for the import of raw material against the export of 3,4-HYDROXY 5-NITRO BENZALDEHYDE-99% MIN. The application has been examined and the Department recommends the following norms for the present Advance Authorization application r

Item of Exp'ort--r'aty:-Titem of 1m-port-_. I Qty , . 3,4-HYDRONZAL~~g[1kgtVANiLLiN99~ . tS88 KGJ E-99% MIN i-DIMETHYL FORMAMIDE---"--: 3.170 KG I i 99.5% i _ __ _ __ "__ "" _ .. 1 ~\ (AK. AGARWAL) Add!. Industrial Adviser Tel. No. 011-2338 1430 Shri Mahender Vikram Singh ,FTDO ,(DES-III) 010 DGFT, Udyog Bhawan,New Delhi -11. Deptt. of C&PC UO. No. 14010/2/2014-CH-1I dated 21 .10.2015

Udyog Bha wan, Ne~v Delhi, the ]4£11 June, ]013 r F. No.350 }}1]341]0 13-PI (Norms) Government of india Ministry of Chemical & Fertilizers Depal1ment of Pharmaceuticals ... ~ ~ect: - Fixati on of norms IInder para 4.7 aI' Hand Boak of Proced ures (VaU) 2 009-14 Case 0f Mis. A Icon B iosciences Pvr Ltd. . The undersigned is directed to refer to DGFT UONo 21S0110B81AM f 3/DES-311220 dated the 26/02113 vide which an application Mis. Alcon 8iosciences Pvt Ltd was sem to this Depal1mem for fixation of under para: 4.7 for the e"pon of Phenytoin SOdiumlBase ThIS em has examined the matter and the following norms are tllrnished under ·4.7 of Hand Book of Procedures (VoU) 2009-14:_ -----------. Qty. Recommended kg/kg. ilTJPOll Item enzil, 99.5% 095 .. Th is issues wi1.0 the approv aI of 0 irector (Cosi) -.. ----- .. _ ..__ .-. __ .---._-

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• ._-.- -. •• (Ra) Kumar) Under Secretary, to the Government ofIndia PI-Norms ctorate General of Foreign Trade, '-- artment of Commerce, s. Lalita Maini, FTDO), Udyog Bhawan, New Delhi. ".- - -- ---- _.....

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j F. NO.35011/322/2016-PI (Norms) Government of India Ministry of Chemicals & Fertilizers Department of Pharmaceuticals . Shastri Bhawan, New Delhi, Dated the January 17, 2017 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of MIs The Andhra Sugars Ltd. The undersigned is directed to refer to DGFT U.O. 1'Jo. 01iS2/171/00037/AM- 17/0ES-II1/552 dated the 07/09/2016 vide which application from Mis. The Andhra Sugars Ltd., was sent to this Department for amendment/revision in description of export product for SION A-39 for export of Acetyl Salicylic Acid. The appiicant has requested to include common name Aspirin against the export product which is a synonym of Acetyl Salicylic Acid. This description is already included vide SION A-77 for Tablets based upon this Drug where the common name Aspirin is qualified by writing Acetyl Salicylic Acid Tablets in the bracket. 2) In view of the foregoing, this Department would like to advise DGFT to consider revision in the description under SION A-39to read as Acetyl Salicylic Acid (Aspirin) in place of Acetyl Salicylic Acid. 3) This issues with the approval of competent authority. ~l~J)~ (Barnali Khastgir) Under Secretary to the Government of India . Phone: 23323292 Email: barn.khast@nic.in Directorate General of Foreign Trade, Department of Commerce, (Shri Nirmal Kumar, Dy DGFT), Udyog Bhawan, New Delhi Email: nirmal.kumar65@nic.in -..-