DGFT Committee Minutes

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. 13/82/2016 of 2016-17 dated 16.11.2016 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 16.11.2016 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. 12/82 scheduled to be held on 28.09.2016 but actually held on 26.10.2016 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 that the items of import/export are not SCOMET items. MEETING NUMBER : 13/82-ALC4/2016 MEETING DATE : 16.11.2016 1

Case No.:67/23/83-ALC1/2012 Party Name:STERICON

PHARMA PVT.LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/83/050/00467/AM13/ RLA File :07/24/040/00154/AM13/ Lic.No/Date:0710089457 04.07.2012 Defer Date: 15.12.2016 Decision :The Committee decided to call for copy of DML from the firm. The Committee accordingly decided to await the reply and deferred the case. 2

Case No.:2/39/83-ALC1/2012

Party Name:LAKE CHEMICALS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/83/050/00737/AM13/ RLA File :07/24/040/00379/AM13/ Lic.No/Date:0710092591 19.12.2012 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/812/2015-PI(Norms) dated June 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. 3

Case No.:121/14/82-

ALC4/2013 Party Name:WANBURY LIMITED(FORMERLY Meet No/Date:13/82- ALC4/2016 Status: Approved

PEARL ORGANICS LTD) 16.11.2016 HQ File :01/82/050/00706/AM14/ RLA File :03/95/040/00505/AM13/ Lic.No/Date:0310745576 16.08.2013 Defer Date: Decision : Approved in Meeting No.12 Case No. B-05. 4

Case No.:24/15/82-ALC4/2013 Party Name:CAMPHOR &

ALLIED PRODUCTS LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00786/AM14/ RLA File :03/94/040/00361/AM14/ Lic.No/Date:0310747725 30.08.2013 Defer Date: 15.12.2016 Decision :Deferred. 5

Case No.:44/13/82-ALC4/2016 Party Name:BEST VALUE

CHEM PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00672/AM17/ RLA File :34/24/040/00143/AM14/ Lic.No/Date:3410037962 17.09.2013 Defer Date: 15.12.2016 Decision : Deferred. 6

Case No.:143/23/82-

ALC4/2013 Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01190/AM14/ RLA File :03/94/040/00776/AM14/ Lic.No/Date:0310761498 11.12.2013 Defer Date: 15.12.2016 7

Case No.:30/7/82-ALC4/2016

Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00204/AM17/ RLA File :22/24/040/00069/AM14/ Lic.No/Date:2210014463 20.12.2013 Defer Date: 15.12.2016 8

Case No.:105/3/82-ALC4/2014 Party Name:THINQ PHARMA-

CRO LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00109/AM15/ RLA File :03/95/040/00842/AM14/ Lic.No/Date:0310771596 24.02.2014 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/441/2015-PI(Norms) dated October 2015, 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. 9

Case No.:52/6/82-ALC4/2014

Party Name:UPL LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File RLA File Lic.No/Date:0310776594 Defer Date:

:01/82/050/00454/AM15/ :03/95/040/01043/AM14/ 01.04.2014 15.12.2016 10

Case No.:34/5/82-ALC4/2014

Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00351/AM15/ RLA File :34/24/040/00003/AM15/ Lic.No/Date:3410039800 15.04.2014 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/566/2014-PI(Norms) dated 05.09.2016, uploaded 11

Case No.:88/6/82-ALC4/2014

Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00490/AM15/ RLA File :03/95/040/00033/AM15/ Lic.No/Date:0310782129 20.05.2014 Defer Date: 15.12.2016 Decision :Deferred. 12

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

Party Name:V & V PHARMA INDUSTRIES Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00309/AM15/ RLA File :03/95/040/00190/AM15/ Lic.No/Date:0310785305 13.06.2014 Defer Date: 15.12.2016 Decision :Deferred. 13

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

Party Name:D. R. COATS INK & RESINS PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 14

Case No.:79/9/82-ALC4/2014

Party Name:METROPOLITAN EXIMCHEM LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00876/AM15/ RLA File :03/95/040/00337/AM15/ Lic.No/Date:0310787073 18.07.2014 Defer Date: 15.12.2016 Decision :Deferred. 15

Case No.:71/8/82-ALC4/2014

Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00735/AM15/ RLA File :34/24/040/00099/AM15/ Lic.No/Date:3410040394 23.07.2014 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/566/2014-PI(Norms) dated 05.09.2016, uploaded

16

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

INDUSTRIES PVT. LTD, Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 17

Case No.:63/8/82-ALC4/2014

Party Name:ADCOCK INGRAM LTD, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00727/AM15/ RLA File :07/24/040/00148/AM15/ Lic.No/Date:0710106181 25.07.2014 Defer Date: 15.12.2016 Decision :Technical information called for from the firm is awaited. The committee decided to await the reply and deferred the case. 18

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

Party Name:CHEMCON SPECIALITY CHEMICALS P LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 19

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

Party Name:V & V PHARMA INDUSTRIES Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 20

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

Party Name:AMBERNATH ORGANICS PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 21

Case No.:21/9/82-ALC4/2014

Party Name:PI INDUSTRIES LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00818/AM15/ RLA File :13/24/040/00020/AM15/ Lic.No/Date:1310047575 12.08.2014 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O. No.15022/6/2010-Ch-II dated 10.08.2016 , 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.

22

Case No.:2/14/82-ALC4/2015

Party Name:SHREE SHIVSHANKAR DRUGS & PHARMACEUTICALS P. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01138/AM16/ RLA File :03/95/040/00425/AM15/ Lic.No/Date:0310788055 14.08.2014 Defer Date: 15.12.2016 Decision :Deferred. 23

Case No.:48/5/82-ALC4/2015

Party Name:VISION DRUGS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00188/AM16/ RLA File :09/24/040/00260/AM15/ Lic.No/Date:0910060860 18.08.2014 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/759/2015-PI(Norms) dated April 2016, uploaded 24

Case No.:215/13/82-

ALC4/2014 Party Name:GOLD STAR CHEMICALS PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01218/AM15/ RLA File :03/94/040/00358/AM15/ Lic.No/Date:0310788338 25.08.2014 Defer Date: 15.12.2016 Decision :Deferred. 25

Case No.:115/13/82-

ALC4/2016 Party Name:MANGALAM DRUGS & ORGANICS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00743/AM17/ RLA File :03/95/040/00419/AM15/ Lic.No/Date:0310788371 26.08.2014 Defer Date: 15.12.2016 Decision :Deferred. 26

Case No.:377/5/82-ALC4/2015 Party Name:ENCUBE

ETHICALS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00517/AM16/ RLA File :03/94/040/00493/AM15/ Lic.No/Date:0310788472 27.08.2014 Defer Date: 15.12.2016 Decision :Information called for from the firm in NC meeting No.05/82 dated 08.06.2016 is awaited. 27

Case No.:224/13/82-

ALC4/2014 Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred.

28

Case No.:225/13/82-

ALC4/2014 Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 29

Case No.:262/13/82-

ALC4/2014 Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01265/AM15/ RLA File :03/94/040/00971/AM14/ Lic.No/Date:0310788560 01.09.2014 Defer Date: 15.12.2016 30

Case No.:223/13/82-

ALC4/2014 Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 31

Case No.:3/7/82-ALC4/2014

Party Name:S V CHEM INTERMEDIATES P LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00647/AM15/ RLA File :04/24/040/00139/AM15/ Lic.No/Date:0410159328 02.09.2014 Defer Date: 15.12.2016 32

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

& CHEMICALS Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 33

Case No.:12/15/82-ALC4/2014 Party Name:JINDAL DRUGS

LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01299/AM15/ RLA File :03/94/040/00460/AM15/ Lic.No/Date:0310789265 16.09.2014 Defer Date: 15.12.2016 34

Case No.:15/13/82-ALC4/2014 Party Name:TATVA

CHINTAN PHARMA CHEM PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01018/AM15/ RLA File :34/24/040/00161/AM15/ Lic.No/Date:3410040594 30.09.2014 Defer Date: 15.12.2016

35

Case No.:19/1/82-ALC4/2015

Party Name:GEM AROMATICS PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01545/AM15/ RLA File :03/94/040/00594/AM15/ Lic.No/Date:0310789922 01.10.2014 Defer Date: 15.12.2016 36

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

SCIENCES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 37

Case No.:124/13/82-

ALC4/2014 Party Name:PANACEA BIOTEC LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision : The Committee noted that information called for from the firm by NC in its meeting No.03/82 dated 12.05.2016 is awaited. The Committee accordingly decided to await the reply from the firm and deferred the case. 38

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

PHARMACEUTICALS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision : The Committee noted that information has been called for from the firm in NC meeting No.07/82 dated 07.07.2016 is awaited. The Committee decided to await the reply and deferred the case. 39

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

CROPSCIENCE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 40

Case No.:43/18/82-ALC4/2014 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01409/AM15/ RLA File :03/95/040/00701/AM15/ Lic.No/Date:0310791419 26.11.2014 Defer Date: 15.12.2016 Decision :Deferred. 41 Case No.:145/5/82-ALC4/2015 Party Name:JINDAL DRUGS Meet No/Date:13/82- Status:

PRIVATE LIMITED ALC4/2016 16.11.2016 Deferred HQ File :01/82/050/00285/AM16/ RLA File :03/94/040/00877/AM15/ Lic.No/Date:0310792112 17.12.2014 Defer Date: 15.12.2016 Decision :Deferred. 42

Case No.:127/5/82-ALC4/2015 Party Name:EMAMI LIMITED, Meet No/Date:13/82-

ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00267/AM16/ RLA File :02/24/040/00183/AM15/ Lic.No/Date:0210205355 18.12.2014 Defer Date: 15.12.2016 43

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

LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 44

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

INDUSTRIES, Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision : Deferred for comments from MSME. 45

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

LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 46

Case No.:99/18/82-ALC4/2014 Party Name:GLOBAL

CALCIUM PRIVATE LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01465/AM15/ RLA File :07/24/040/00302/AM15/ Lic.No/Date:0710107307 30.12.2014 Defer Date: 15.12.2016 47

Case No.:111/18/82-

ALC4/2014 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01477/AM15/ RLA File :07/24/040/00307/AM15/ Lic.No/Date:0710107306 30.12.2014 Defer Date: 15.12.2016

48

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

Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision : Deferred for want of comments from DoP. 49

Case No.:102/5/82-ALC4/2015 Party Name:ALTA

LABORATORIES LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00242/AM16/ RLA File :03/94/040/00836/AM15/ Lic.No/Date:0310792635 07.01.2015 Defer Date: 15.12.2016 50

Case No.:74/5/82-ALC4/2015

Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00214/AM16/ RLA File :03/95/040/00833/AM15/ Lic.No/Date:0310792647 07.01.2015 Defer Date: 15.12.2016 Decision :Deferred. 51

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

LABORATORIES Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 52

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

CHEMICALS & INDUSTRIES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 53

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

CHEMICALS PVT LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision : The Committee noted that an investigation in the matter is under process. The Committee accordingly, decided to defer the case. 54

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

Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File RLA File Lic.No/Date:0510392949 Defer Date:

:01/82/050/00228/AM16/ :05/23/040/00486/AM15/ 21.01.2015 15.12.2016 Decision : Deferred for want of comments from AYUSH 55

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

PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00934/AM16/ RLA File :03/94/040/01099/AM14/ Lic.No/Date:0310793426 30.01.2015 Defer Date: 15.12.2016 Decision : Information received and sent to DoP for comments. 56

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

CROPSCIENCE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 57

Case No.:133/7/82-ALC4/2016 Party Name:SIRMAXO

CHEMICALS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00307/AM17/ RLA File :03/95/040/00911/AM15/ Lic.No/Date:0310793837 12.02.2015 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.03/82 dated 08.05.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 58

Case No.:285/5/82-ALC4/2015 Party Name:CAMPHOR &

ALLIED PRODUCTS LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00425/AM16/ RLA File :03/94/040/01092/AM15/ Lic.No/Date:0310793985 19.02.2015 Defer Date: 15.12.2016 Decision :Deferred. 59

Case No.:279/5/82-ALC4/2015 Party Name:CROWN

CHEMICALS PVT.LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00419/AM16/ RLA File :03/94/040/01088/AM15/ Lic.No/Date:0310793983 19.02.2015 Defer Date: 15.12.2016 Decision :Deferred. 60

Case No.:288/5/82-ALC4/2015 Party Name:CROWN

CHEMICALS PVT.LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00428/AM16/ RLA File :03/94/040/01089/AM15/ Lic.No/Date:0310793982 19.02.2015 Defer Date: 15.12.2016 Decision :Deferred.

61

Case No.:335/5/82-ALC4/2015 Party Name:PRIVI ORGANICS

LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00475/AM16/ RLA File :03/95/040/00978/AM15/ Lic.No/Date:0310794038 20.02.2015 Defer Date: 15.12.2016 Decision :Deferred. 62

Case No.:334/5/82-ALC4/2015 Party Name:UPL

LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00474/AM16/ RLA File :03/95/040/00862/AM15/ Lic.No/Date:0310794100 24.02.2015 Defer Date: 15.12.2016 Decision :Deferred. 63

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

VALLABH CHEMICAL Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 64

Case No.:75/4/82-ALC4/2015

Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00114/AM16/ RLA File :09/24/040/00564/AM15/ Lic.No/Date:0910061653 26.02.2015 Defer Date: 15.12.2016 65

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

SERUMS & VACCINES LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision : Deferred for want of comments from DBT 66

Case No.:452/5/82-ALC4/2015 Party Name:BLUE CIRCLE

ORGANICS PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00592/AM16/ RLA File :03/94/040/01091/AM15/ Lic.No/Date:0310794261 27.02.2015 Defer Date: 15.12.2016 Decision :Deferred 67

Case No.:295/5/82-ALC4/2015 Party Name:PROLIFE

INDUSTRIES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00435/AM16/ RLA File :08/24/040/00395/AM15/ Lic.No/Date:0810134703 03.03.2015 Defer Date: 15.12.2016 Decision :Deferred.

68

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

DYESTUFF PVT. LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 69

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

PETROCHEMICALS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 70

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

INDUSTRIES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 71

Case No.:45/4/82-ALC4/2015

Party Name:TIDE INDUSTRIES Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00084/AM16/ RLA File :34/24/040/00325/AM15/ Lic.No/Date:3410041050 16.03.2015 Defer Date: C&PU.O.No.14010/40/2011-Ch-II dated 04.03.2016, 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.:291/5/82-ALC4/2015 Party Name:JUBILANT LIFE

SCIENCES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00431/AM16/ RLA File :05/23/040/00544/AM15/ Lic.No/Date:0510393616 18.03.2015 Defer Date: 15.12.2016 Decision :Deferred. 73

Case No.:183/5/82-ALC4/2015 Party Name:SPAK

ORGOCHEM (INDIA) PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00323/AM16/ RLA File :03/95/040/00964/AM15/ Lic.No/Date:0310794811 23.03.2015 Defer Date: 15.12.2016 Decision :Deferred. 74 Case No.:29/5/82-ALC4/2015 Party Name:ASSOCIATED DYESTUFF PVT. LTD Meet No/Date:13/82- ALC4/2016 Status: Deferred

16.11.2016 HQ File :01/82/050/00169/AM16/ RLA File :08/24/040/00483/AM15/ Lic.No/Date:0810134917 25.03.2015 Defer Date: 15.12.2016 Decision :Deferred. 75

Case No.:29/1/82-ALC4/2015

Party Name:HONOUR LAB LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/01555/AM15/ RLA File :09/24/040/00722/AM15/ Lic.No/Date:0910061789 30.03.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/692/2015-PI(Norms) dated 26.02.2016, uploaded 76

Case No.:82/4/82-

ALC4/2015 Party Name:BIOLOGICAL E LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00121/AM16/ RLA File :09/24/040/00663/AM15/ Lic.No/Date:0910061841 31.03.2015 Defer Date: 15.12.201616.11.2016 77

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

Party Name:CONTINENTAL CHEMICALS Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 78

Case No.:35/5/82-ALC4/2015

Party Name:VIVIMED LABS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00175/AM16/ RLA File :09/24/040/00739/AM15/ Lic.No/Date:0910061891 17.04.2015 Defer Date: 15.12.2016 Decision :Deferred. 79

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

TROTTERS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 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. 80

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

Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File RLA File Lic.No/Date:0910061937 Defer Date:

:01/82/050/00836/AM16/ :09/24/040/00042/AM16/ 27.04.2015 15.12.2016 Decision :Deferred. 81

Case No.:68/4/82-ALC4/2015

Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00107/AM16/ RLA File :34/24/040/00003/AM16/ Lic.No/Date:3410041183 28.04.2015 Defer Date: 15.12.2016 Decision :Deferred. 82

Case No.:174/5/82-ALC4/2015 Party Name:GLOBAL

CALCIUM PRIVATE LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00314/AM16/ RLA File :07/24/040/00393/AM15/ Lic.No/Date:0710108142 01.05.2015 Defer Date: 15.12.2016 Decision :Deferred. 83

Case No.:176/5/82-ALC4/2015 Party Name:GLOBAL

CALCIUM PRIVATE LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00316/AM16/ RLA File :07/24/040/00389/AM15/ Lic.No/Date:0710108141 01.05.2015 Defer Date: 15.12.2016 Decision :Deferred. 84

Case No.:177/5/82-ALC4/2015 Party Name:GLOBAL

CALCIUM PRIVATE LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00317/AM16/ RLA File :07/24/040/00390/AM15/ Lic.No/Date:0710108143 01.05.2015 Defer Date: 15.12.2016 85

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

Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 86

Case No.:65/8/82-ALC4/2015

Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00861/AM16/ RLA File :09/24/040/00052/AM16/ Lic.No/Date:0910061973 06.05.2015 Defer Date: 15.12.2016 Decision : The Committee noted that Information has been called for from the firm in NC meeting No.03 dated 12.05.2016 is awaited. The Committee accordingly deferred the case.

87

Case No.:7/5/82-ALC4/2015

Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00147/AM16/ RLA File :05/23/040/00037/AM16/ Lic.No/Date:0510394177 08.05.2015 Defer Date: 15.12.2016 Decision : The Committee noted that Information has been called for from the firm in NC meeting No.03 dated 12.05.2016 is awaited. The Committee accordingly deferred the case. 88

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

Party Name:ASCENT FINECHEM PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 89

Case No.:45/8/82-ALC4/2015

Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00841/AM16/ RLA File :05/24/040/00073/AM16/ Lic.No/Date:0510394342 25.05.2015 Defer Date: 15.12.2016 Decision : The Committee noted that Information has been called for from the firm in NC meeting No.20 dated 09.03.2016 is awaited. The Committee accordingly deferred the case. 90

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

Party Name:VIVIMED LABS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 91

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

Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00792/AM16/ RLA File :08/24/040/00057/AM16/ Lic.No/Date:0810135435 05.06.2015 Defer Date: 15.12.2016 Decision :Deferred. 92

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

SCIENCES LIMITED. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00652/AM17/ RLA File :09/24/040/00034/AM16/ Lic.No/Date:0910062155 10.06.2015 Defer Date: 15.12.2016 Decision :Deferred for want of comments from DoP. 93 Case No.:121/8/82-ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:13/82- ALC4/2016 Status: Deferred

16.11.2016 HQ File :01/82/050/00917/AM16/ RLA File :03/95/040/00190/AM16/ Lic.No/Date:0310796766 23.06.2015 Defer Date: 15.12.2016 Decision :Deferred. 94

Case No.:41/7/82-ALC4/2016

Party Name:DEEPAK NITRITE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00215/AM17/ RLA File :34/24/040/00082/AM16/ Lic.No/Date:3410041319 24.06.2015 Defer Date: Decision : The Committee decided to ratify norms based on earlier decision taken by NC in its meeting No.28/82 dated 10.01.2013, 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. 95

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

Party Name:HALDIA PETROCHEMICALS LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 96

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

LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 97

Case No.:109/14/82-

ALC4/2015 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/01245/AM16/ RLA File :09/24/040/00195/AM16/ Lic.No/Date:0910062283 02.07.2015 Defer Date: its meeting No.24/82 dated 27.03.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 98

Case No.:54/8/82-ALC4/2015

Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00850/AM16/ RLA File :05/23/040/00150/AM16/ Lic.No/Date:0510394862 09.07.2015 Defer Date: 15.12.2016 Decision : The Committee noted that Information has been called for from the firm in NC meeting No.03 dated 12.05.2016 is awaited. The Committee accordingly deferred the case.

99

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

Party Name:PUSILIN BIOTECHNOLOGY PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred for want of comments from DBT. 100

Case No.:27/13/82-ALC4/2016 Party Name:SANMAR

SPECIALITY CHEMICALS LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00655/AM17/ RLA File :04/24/040/00066/AM16/ Lic.No/Date:0410160801 14.07.2015 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.10/82 dated 05.06.2012 , 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. 101

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

LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 meeting No.03 dated 12.05.2016 is awaited. The Committee decided to await the reply and deferred the case. 102

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

LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 meeting No.03 dated 12.05.2016 is awaited. The Committee decided to await the reply and deferred the case. 103

Case No.:41/14/82-ALC4/2015 Party Name:DEEPAK

NITRITE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/01177/AM16/ RLA File :34/24/040/00031/AM16/ Lic.No/Date:3410041376 15.07.2015 Defer Date: Decision : The Committee decided to ratify norms based on earlier decision taken by NC in its meeting No.28/82 dated 10.01.2013, 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. 104

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

Party Name:M.L.A. INDUSTRIES Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 105

Case No.:120/8/82-ALC4/2015 Party Name:PERFECT

VITAMINS PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00916/AM16/ RLA File :03/95/040/00304/AM16/ Lic.No/Date:0310797293 16.07.2015 Defer Date: 15.12.2016 Decision :Deferred. 106

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

CHIRALS PVT. LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 107

Case No.:39/14/82-ALC4/2015 Party Name:JAGSONPAL

PHARMACEUTICALS LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01175/AM16/ RLA File :05/23/040/00165/AM16/ Lic.No/Date:0510395004 20.07.2015 Defer Date: 15.12.2016 meeting No.03 dated 12.05.2016 is awaited. The Committee decided to await the reply and deferred the case. 108

Case No.:21/16/82-ALC4/2015 Party Name:OPTIMUS

DRUGS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01341/AM16/ RLA File :09/24/040/00223/AM16/ Lic.No/Date:0910062361 22.07.2015 Defer Date: 15.12.2016 meeting No.05 dated 08.06.2016 is awaited. The Committee decided to await the reply and deferred the case. 109

Case No.:149/14/82-

ALC4/2015 Party Name:VISION DRUGS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/01285/AM16/ RLA File :09/24/040/00230/AM16/ Lic.No/Date:0910062365 23.07.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/759/2015-PI(Norms) dated April 2016, uploaded 110 Case No.:1/10/82-ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE Meet No/Date:13/82- ALC4/2016 Status: Deferred

LIMITED 16.11.2016 HQ File :01/82/050/00957/AM16/ RLA File :09/24/040/00211/AM16/ Lic.No/Date:0910062393 28.07.2015 Defer Date: 15.12.2016 Decision :Deferred. 111

Case No.:131/14/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 112

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

LABORATORIES PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 113

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

Party Name:CADILA Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01858/AM16/ RLA File :08/91/040/00210/AM16/ Lic.No/Date:0810135770 03.08.2015 Defer Date: 15.12.2016 114

Case No.:169/14/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 115

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

Party Name:VIVIMED LABS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 116

Case No.:168/14/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred.

117

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

EXIMCHEM PRIVATE LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 118

Case No.:115/16/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01435/AM16/ RLA File :03/95/040/00164/AM16/ Lic.No/Date:0310798051 10.08.2015 Defer Date: 15.12.2016 Decision : Technical information has been received and sent to DoP for comments. 119

Case No.:23/8/82-ALC4/2015

Party Name:ALPHAMED FORMULATIONS P LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00819/AM16/ RLA File :09/24/040/00091/AM16/ Lic.No/Date:0910062478 11.08.2015 Defer Date: 15.12.2016 meeting No.03 dated 12.05.2016 is awaited. The Committee decided to await the reply and deferred the case. 120

Case No.:155/14/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 meeting No.03 dated 12.05.2016 is awaited. The Committee decided to await the reply and deferred the case. 121

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

AUXILIARIES PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 122

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

INDUSTRY LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 123 Case No.:99/14/82-ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 Status: Deferred

16.11.2016 HQ File :01/82/050/01235/AM16/ RLA File :09/24/040/00231/AM16/ Lic.No/Date:0910062516 18.08.2015 Defer Date: 15.12.2016 meeting No20/82 dated 09.03.2016 is awaited. The Committee decided to await the 124

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

BIOTEC LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 meeting No03/82 dated 12.05.2016 is awaited. The Committee decided to await the 125

Case No.:154/14/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01290/AM16/ RLA File :05/24/040/00381/AM15/ Lic.No/Date:0510395357 19.08.2015 Defer Date: 15.12.2016 Decision :Deferred. 126

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

CHEMICALS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 127

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

SPECIALTY PRODUCTS Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 128

Case No.:117/13/82-

ALC4/2016 Party Name:SOFTGEL HEALTH CARE PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00745/AM17/ RLA File :04/24/040/00092/AM16/ Lic.No/Date:0410160962 28.08.2015 Defer Date: 15.12.2016 129

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

PETROCHEM PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred

HQ File :01/82/050/01218/AM16/ RLA File :05/24/040/00233/AM16/ Lic.No/Date:0510395480 31.08.2015 Defer Date: 15.12.2016 Decision :Deferred. 130

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

PETROCHEM PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01225/AM16/ RLA File :05/24/040/00224/AM16/ Lic.No/Date:0510395479 31.08.2015 Defer Date: 15.12.2016 Decision :Deferred. 131

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

PETROCHEM PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01230/AM16/ RLA File :05/24/040/00202/AM16/ Lic.No/Date:0510395481 31.08.2015 Defer Date: 15.12.2016 Decision :Deferred. 132

Case No.:116/16/82-

ALC4/2015 Party Name:PANERA BIOTEC PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred for want of comments from DBT. 133

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

PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01229/AM16/ RLA File :05/24/040/00244/AM16/ Lic.No/Date:0510395493 01.09.2015 Defer Date: 15.12.2016 meeting No05/82 dated 08.06.2016 is awaited. The Committee decided to await the 134

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

INDUSTRIES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 meeting No.03/82 dated 12.05.2016 is awaited. The Committee decided to await the 135

Case No.:59/11/82-ALC4/2016 Party Name:AMI ORGANICS

PVT LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00593/AM17/ RLA File :52/24/040/00040/AM16/ Lic.No/Date:5210041626 04.09.2015 Defer Date: 15.12.2016

Decision :Deferred. 136

Case No.:141/14/82-

ALC4/2015 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01277/AM16/ RLA File :17/24/040/00050/AM16/ Lic.No/Date:1710006170 04.09.2015 Defer Date: 15.12.2016 Decision :Deferred. 137

Case No.:52/14/82-ALC4/2015 Party Name:OPTIMUS

DRUGS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01188/AM16/ RLA File :09/24/040/00323/AM16/ Lic.No/Date:0910062554 04.09.2015 Defer Date: 15.12.2016 meeting No.03/82 dated 12.05.2016 is awaited. The Committee decided to await the 138

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

CHEMICALS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01192/AM16/ RLA File :09/24/040/00134/AM16/ Lic.No/Date:0910062560 08.09.2015 Defer Date: 15.12.2016 Decision :Deferred. 139

Case No.:124/16/82-

ALC4/2015 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01444/AM16/ RLA File :03/94/040/00399/AM16/ Lic.No/Date:0310798771 09.09.2015 Defer Date: 15.12.2016 Decision :Deferred. 140

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

OXYGEN & INDUSTRIAL GASES PVT.LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 141

Case No.:53/14/82-ALC4/2015 Party Name:RA CHEM

PHARMA LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01189/AM16/ RLA File :09/24/040/00315/AM16/ Lic.No/Date:0910062581 09.09.2015 Defer Date: 15.12.2016 142 Case No.:157/14/82- Party Name:AETHER Meet No/Date:13/82- Status:

ALC4/2015 INDUSTRIES LIM ITED ALC4/2016 16.11.2016 Deferred HQ File :01/82/050/01293/AM16/ RLA File :52/24/040/00042/AM16/ Lic.No/Date:5210041630 10.09.2015 Defer Date: 15.12.2016 Decision :Deferred. 143

Case No.:9/16/82-ALC4/2015

Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01329/AM16/ RLA File :09/24/040/00328/AM16/ Lic.No/Date:0910062593 11.09.2015 Defer Date: 15.12.2016 meeting No05/82 dated 08.06.2016 is awaited. The Committee decided to await the 144

Case No.:56/16/82-ALC4/2015 Party Name:BENZO CHEM

INDUSTRIES PRIVATE LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01376/AM16/ RLA File :03/94/040/00435/AM16/ Lic.No/Date:0310798876 14.09.2015 Defer Date: 15.12.2016 Decision :Deferred. 145

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

Party Name:PRIVI ORGANICS LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01144/AM16/ RLA File :03/95/040/00343/AM16/ Lic.No/Date:0310798846 14.09.2015 Defer Date: 15.12.2016 Decision :Deferred. 146

Case No.:110/14/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01246/AM16/ RLA File :09/24/040/00305/AM16/ Lic.No/Date:0910062601 14.09.2015 Defer Date: 15.12.2016 Decision :Deferred. 147

Case No.:134/14/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01270/AM16/ RLA File :09/24/040/00273/AM16/ Lic.No/Date:0910062602 14.09.2015 Defer Date: 15.12.2016 Decision :Deferred. 148

Case No.:7/14/82-ALC4/2015

Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01143/AM16/ RLA File :03/95/040/00426/AM16/ Lic.No/Date:0310798872 14.09.2015 Defer Date: 15.12.2016

Decision :Technical information has been received and sent to DoP for comments. 149

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

CHEM PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01210/AM16/ RLA File :34/24/040/00120/AM16/ Lic.No/Date:3410041510 15.09.2015 Defer Date: 15.12.2016 Decision :Deferred. 150

Case No.:15/14/82-ALC4/2015 Party Name:NEW ALLIANCE

DYE-CHEM PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01151/AM16/ RLA File :03/95/040/00360/AM16/ Lic.No/Date:0310798909 15.09.2015 Defer Date: 15.12.2016 Decision :Deferred. 151

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

Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 152

Case No.:124/14/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01260/AM16/ RLA File :09/24/040/00355/AM16/ Lic.No/Date:0910062622 16.09.2015 Defer Date: 15.12.2016 Decision :Deferred. 153

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

& RESINS PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 154

Case No.:34/16/82-ALC4/2015 Party Name:KOPRAN

RESEARCH LABORATORIES LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01354/AM16/ RLA File :03/94/040/00472/AM16/ Lic.No/Date:0310798979 21.09.2015 Defer Date: 15.12.2016 meeting No03/82 dated 12.05.2016 is awaited. The Committee decided to await the 155 Case No.:64/21/82-ALC4/2015 Party Name:CADILA Meet No/Date:13/82- Status:

HEALTHCARE LTD., ALC4/2016 16.11.2016 Deferred HQ File :01/82/050/01769/AM16/ RLA File :08/24/040/00137/AM16/ Lic.No/Date:0810136085 22.09.2015 Defer Date: 15.12.2016 Decision :deferred. 156

Case No.:64/14/82-ALC4/2015 Party Name:RA CHEM

PHARMA LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01200/AM16/ RLA File :09/24/040/00375/AM16/ Lic.No/Date:0910062644 22.09.2015 Defer Date: 15.12.2016 meeting No.20/82 dated 09.03.2016 is awaited. The Committee decided to await the 157

Case No.:117/14/82-

ALC4/2015 Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 meeting No.07/82 dated 07.07.2016 is awaited. The Committee decided to await the 158

Case No.:103/14/82-

ALC4/2015 Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01239/AM16/ RLA File :09/24/040/00362/AM16/ Lic.No/Date:0910062635 22.09.2015 Defer Date: 15.12.2016 meeting No.03/82 dated 12.05.2016 is awaited. The Committee decided to await the 159

Case No.:25/20/82-ALC4/2015 Party Name:AMOL

PHARMACEUTICALS PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01608/AM16/ RLA File :13/24/040/00027/AM16/ Lic.No/Date:1310047981 23.09.2015 Defer Date: 15.12.2016 meeting No.11/82 dated 07.08.2016 is awaited. The Committee decided to await the 160

Case No.:106/14/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016

meeting No.07/82 dated 07.07.2016 is awaited. The Committee decided to await the 161

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

SKINCARE Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 meeting No.07/82 dated 07.07.2016 is awaited. The Committee decided to await the 162

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

HAPPY HYGIENECARE PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 meeting No.09/82 dated 10.08.2016 is awaited. The Committee decided to await the 163

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

PHARMACEUTICALS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred for want of comments from DBT. 164

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

INDUSTRIES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 165

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

INDUSTRIES LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01363/AM16/ RLA File :03/94/040/00423/AM16/ Lic.No/Date:0310799184 05.10.2015 Defer Date: 15.12.2016 Decision :Deferred. 166

Case No.:67/16/82-ALC4/2015 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01387/AM16/ RLA File :03/95/040/00485/AM16/ Lic.No/Date:0310799241 06.10.2015 Defer Date: 15.12.2016

Decision :Deferred. 167

Case No.:139/14/82-

ALC4/2015 Party Name:MAMTA POLYCOATS Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 168

Case No.:126/16/82-

ALC4/2015 DYE-CHEM PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01446/AM16/ RLA File :03/95/040/00445/AM16/ Lic.No/Date:0310799287 08.10.2015 Defer Date: 15.12.2016 Decision :Deferred. 169

Case No.:61/16/82-ALC4/2015 Party Name:SHALINA

LABORATORIES PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01381/AM16/ RLA File :03/95/040/00483/AM16/ Lic.No/Date:0310799284 08.10.2015 Defer Date: 15.12.2016 Decision :Technical information has been received and sent to DoP for comments. 170

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

TECHNOLOGIES PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 171

Case No.:17/16/82-ALC4/2015 Party Name:VISION DRUGS

PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/01337/AM16/ RLA File :09/24/040/00402/AM16/ Lic.No/Date:0910062693 08.10.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/759/2015-PI(Norms) dated April 2016, uploaded 172

Case No.:164/14/82-

ALC4/2015 Party Name:AASHA BIOCHEM Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 meeting No.05/82 dated 08.06.2016 is awaited. The Committee decided to await the

173

Case No.:140/14/82-

ALC4/2015 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01276/AM16/ RLA File :34/24/040/00175/AM16/ Lic.No/Date:3410041586 12.10.2015 Defer Date: 15.12.2016 Decision :Deferred. 174

Case No.:132/14/82-

ALC4/2015 Party Name:RIDDHI PHARMA Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01268/AM16/ RLA File :34/24/040/00180/AM16/ Lic.No/Date:3410041592 14.10.2015 Defer Date: 15.12.2016 Decision :Deferred. 175

Case No.:92/16/82-ALC4/2015 Party Name:TRANSPEK

INDUSTRY LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/01412/AM16/ RLA File :34/24/040/00185/AM16/ Lic.No/Date:3410041600 15.10.2015 Defer Date: its meeting No.49/82 dated 06.03.2012, 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. 176

Case No.:116/13/82-

ALC4/2016 Party Name:SOFTGEL HEALTH CARE PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00744/AM17/ RLA File :04/24/040/00143/AM16/ Lic.No/Date:0410161132 20.10.2015 Defer Date: 15.12.2016 177

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

AUXILIARIES PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 178

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

AUXILIARIES PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 179 Case No.:29/16/82-ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE Meet No/Date:13/82- ALC4/2016 Status: Deferred

LIMITED 16.11.2016 HQ File :01/82/050/01349/AM16/ RLA File :09/24/040/00379/AM16/ Lic.No/Date:0910062768 23.10.2015 Defer Date: 15.12.2016 Decision :Deferred. 180

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

CHEMICALS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01350/AM16/ RLA File :09/24/040/00383/AM16/ Lic.No/Date:0910062767 23.10.2015 Defer Date: 15.12.2016 Decision :Deferred. 181

Case No.:129/16/82-

ALC4/2015 Party Name:SURVIVAL Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 182

Case No.:161/14/82-

ALC4/2015 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 183

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

ORGANICS PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01398/AM16/ RLA File :03/95/040/00777/AM15/ Lic.No/Date:0310799666 26.10.2015 Defer Date: 15.12.2016 Decision :Deferred. 184

Case No.:53/20/82-ALC4/2015 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01636/AM16/ RLA File :03/95/040/00529/AM16/ Lic.No/Date:0310799675 26.10.2015 Defer Date: 15.12.2016 Decision :Deferred. 18 5

Case No.:93/16/82-

ALC4/2015 Party Name:JAINEX SPECIALITY CHEMICA L Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01413/AM16 / RLA File :34/24/040/00196/AM16/ Lic.No/Date:341004162 6 28.10.2015 Defer Date: 15.12.201 6 Decision :Deferred.

186

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

LABORATORIES PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 meeting No.05/82 dated 08.06.2016 is awaited. The Committee decided to await the 187

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

VITAMINS PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 188

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

Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 189

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

Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 190

Case No.:136/14/82-

ALC4/2015 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01272/AM16/ RLA File :05/23/040/00293/AM16/ Lic.No/Date:0510396078 30.10.2015 Defer Date: 15.12.2016 meeting No.03/82 dated 12.05.2016 is awaited. The Committee decided to await the 191

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

SPECIALITIES PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 192 Case No.:159/14/82- Party Name:SUN Meet No/Date:13/82- Status:

ALC4/2015 PHARMACEUTICAL INDUSTRIES LTD., ALC4/2016 16.11.2016 Deferred HQ File :01/82/050/01295/AM16/ RLA File :05/24/040/00343/AM16/ Lic.No/Date:0510396075 30.10.2015 Defer Date: 15.12.2016 meeting No.03 dated 12.05.2016 is awaited. The Committee decided to await the reply and deferred the case. 193

Case No.:118/16/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 meeting No.03 dated 12.05.2016 is awaited. 194

Case No.:84/16/82-ALC4/2015 Party Name:VENUS

REMEDIES LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01404/AM16/ RLA File :22/24/040/00055/AM16/ Lic.No/Date:2210015339 30.10.2015 Defer Date: 15.12.2016 meeting No.03 dated 12.05.2016 is awaited. 195

Case No.:112/16/82-

ALC4/2015 Party Name:BELCO PHARMA Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01432/AM16/ RLA File :05/23/040/00273/AM16/ Lic.No/Date:0510396205 03.11.2015 Defer Date: 15.12.2016 196

Case No.:107/16/82-

ALC4/2015 Party Name:HELLO PAINTS (P) LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01427/AM16/ RLA File :05/23/040/00326/AM16/ Lic.No/Date:0510396204 03.11.2015 Defer Date: 15.12.2016 Decision :Deferred. 197

Case No.:19/16/82-ALC4/2015 Party Name:MEDICLONE

BIO-TECH PRIVATE LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/01339/AM16/ RLA File :04/24/040/00181/AM16/ Lic.No/Date:0410161279 04.11.2015 Defer Date: Decision :The Committee noted that this case has already been approved in meeting No.07/72 dated07.07.2016 at Sl.No.226. The Committee decided to withdraw the case. 198 Case No.:90/16/82-ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:13/82- ALC4/2016 Status: Deferred

16.11.2016 HQ File :01/82/050/01410/AM16/ RLA File :34/24/040/00207/AM16/ Lic.No/Date:3410041662 05.11.2015 Defer Date: 15.12.2016 Decision :Deferred. 199

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

PHARMACHEM LTD, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01408/AM16/ RLA File :34/24/040/00202/AM16/ Lic.No/Date:3410041663 05.11.2015 Defer Date: 15.12.2016 Decision :Deferred. 200

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

ORGANIC INDUSTRIES LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 201

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

CHEMICALS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 202

Case No.:2/16/82-ALC4/2015

Party Name:SANO MEDICAL KITS PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01322/AM16/ RLA File :04/24/040/00175/AM16/ Lic.No/Date:0410161296 09.11.2015 Defer Date: 15.12.2016 Decision :The Committee decided to call for copy of DML and photograph of export and import items from the firm. The Committee accordingly decided to await the reply and deferred the case. 203

Case No.:34/1/82-ALC1/2016

Party Name:GLAND PHARMA LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01808/AM16/ RLA File :09/24/040/00469/AM16/ Lic.No/Date:0910062848 10.11.2015 Defer Date: 15.12.2016 Decision : The Committee decided to call for copy of DML from the firm and deferred the case. 204

Case No.:114/16/82-

ALC4/2015 Party Name:SHIVA BIOCHEM INDUSTRIES Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016

Decision :Deferred. 205

Case No.:104/16/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01424/AM16/ RLA File :05/23/040/00339/AM16/ Lic.No/Date:0510396384 20.11.2015 Defer Date: 15.12.2016 Decision : The Committee noted that information called for from the firm in NC meeting No.18/82 dated 10.02.2016 is awaited. The Committee accordingly deferred the case. 206

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

Party Name:AIMS IMPEX PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 207

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

Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 208

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

Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01585/AM16/ RLA File :05/24/040/00400/AM16/ Lic.No/Date:0510396400 23.11.2015 Defer Date: 15.12.2016 Decision :Deferred. 209

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

Party Name:INCHEM LABORATORIES PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01807/AM16/ RLA File :09/24/040/00486/AM16/ Lic.No/Date:0910062902 26.11.2015 Defer Date: 15.12.2016 Decision : The Committee noted that information called for from the firm in NC meeting No.07/82 dated 07.07.2016 is awaited. The Committee accordingly deferred the case. 210

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

Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision : The Committee noted that information called for from the firm in NC meeting No.05/82 dated 08.06.2016 is awaited. The Committee accordingly deferred the case. 211 Case No.:2/1/82-ALC1/2016 Party Name:UNIJULES LIFE SCIENCES LTD. Meet No/Date:13/82- ALC4/2016 Status: Deferred

16.11.2016 HQ File :01/82/050/01776/AM16/ RLA File :03/95/040/00632/AM16/ Lic.No/Date:0310800416 26.11.2015 Defer Date: 15.12.2016 212

Case No.:23/1/82-ALC1/2016

Party Name:UNILINK PHARMA PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01797/AM16/ RLA File :04/24/040/00170/AM16/ Lic.No/Date:0410161342 26.11.2015 Defer Date: 15.12.2016 213

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

CHEMICALS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 214

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

Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 215

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

Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 216

Case No.:33/20/82-ALC4/2015 Party Name:HUBERGROUP

INDIA PRIVATE LIMITED. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/01616/AM16/ RLA File :03/94/040/00532/AM16/ Lic.No/Date:0310800597 02.12.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC U.O.No.14010/24/2013-Ch-II dated 19.10.2015, 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. 217

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

SPECIALITY CHEMICALS PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01637/AM16/ RLA File :03/95/040/00631/AM16/ Lic.No/Date:0310800619 03.12.2015 Defer Date: 15.12.2016

Decision :Deferred. 218

Case No.:112/20/82-

ALC4/2015 Party Name:SUPREET CHEMICALS PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 219

Case No.:87/20/82-ALC4/2015 Party Name:NEW ALLIANCE

DYE-CHEM PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01670/AM16/ RLA File :03/95/040/00605/AM16/ Lic.No/Date:0310800715 07.12.2015 Defer Date: 15.12.2016 Decision :Deferred. 220

Case No.:127/16/82-

ALC4/2015 Party Name:BLUELINE FOODS (INDIA) PVT.LTD, Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision : Information called for from the firm in NC meeting No.03/AM17 dated 12.05.2016 is awaited. The committee accordingly deferred the case. 221

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

PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 222

Case No.:67/20/82-ALC4/2015 Party Name:MANGALAM

ORGANICS LIMITED (FORMERLY DUJODWALA Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01650/AM16/ RLA File :03/95/040/00054/AM16/ Lic.No/Date:0310800865 10.12.2015 Defer Date: 15.12.2016 Decision :Deferred. 223

Case No.:110/20/82-

ALC4/2015 Party Name:PROCESS AGROCHEM INDUSTRIES PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 224

Case No.:39/20/82-ALC4/2015 Party Name:CAMPHOR &

ALLIED PRODUCTS LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred

HQ File :01/82/050/01622/AM16/ RLA File :03/94/040/00088/AM16/ Lic.No/Date:0310800889 11.12.2015 Defer Date: 15.12.2016 Decision :Deferred. 225

Case No.:41/20/82-ALC4/2015 Party Name:CAMPHOR &

ALLIED PRODUCTS LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01624/AM16/ RLA File :03/94/040/00648/AM16/ Lic.No/Date:0310800905 11.12.2015 Defer Date: 15.12.2016 Decision :Deferred. 226

Case No.:9/1/82-ALC1/2016

Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01783/AM16/ RLA File :03/94/040/00490/AM16/ Lic.No/Date:0310800912 11.12.2015 Defer Date: 15.12.2016 Decision :Deferred. 227

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

LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01649/AM16/ RLA File :03/95/040/00633/AM16/ Lic.No/Date:0310800935 11.12.2015 Defer Date: 15.12.2016 Decision :Deferred. 228

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

ANTIOXIDANTS PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01628/AM16/ RLA File :03/94/040/00736/AM16/ Lic.No/Date:0310800992 14.12.2015 Defer Date: 15.12.2016 Decision :Deferred. 229

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

FLUORINE INTERNATIONAL LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :deferred. 230

Case No.:49/20/82-ALC4/2015 Party Name:BENZO CHEM

INDUSTRIES PRIVATE LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01632/AM16/ RLA File :03/94/040/00714/AM16/ Lic.No/Date:0310801093 16.12.2015 Defer Date: 15.12.2016 Decision :Deferred. 231 Case No.:10/1/82-ALC1/2016 Party Name:BENZO CHEM Meet No/Date:13/82- Status:

INDUSTRIES PRIVATE LIMITED, ALC4/2016 16.11.2016 Deferred HQ File :01/82/050/01784/AM16/ RLA File :03/94/040/00630/AM16/ Lic.No/Date:0310801130 16.12.2015 Defer Date: 15.12.2016 Decision :Deferred. 232

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

PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01629/AM16/ RLA File :03/94/040/00692/AM16/ Lic.No/Date:0310801111 16.12.2015 Defer Date: 15.12.2016 Decision :Deferred. 233

Case No.:23/20/82-ALC4/2015 Party Name:NEW ALLIANCE

DYE-CHEM PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01606/AM16/ RLA File :03/95/040/00697/AM16/ Lic.No/Date:0310801116 16.12.2015 Defer Date: 15.12.2016 Decision :Deferred. 234

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

Party Name:SHREE BANKEY BEHARI LAL BOARD MILLS Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01591/AM16/ RLA File :05/24/040/00427/AM16/ Lic.No/Date:0510396637 16.12.2015 Defer Date: 15.12.2016 Decision :Deferred. 235

Case No.:8/1/82-ALC1/2016

Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01782/AM16/ RLA File :03/94/040/00754/AM16/ Lic.No/Date:0310801214 18.12.2015 Defer Date: 15.12.2016 Decision :Deferred. 236

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

Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01857/AM16/ RLA File :03/94/040/00752/AM16/ Lic.No/Date:0310801211 18.12.2015 Defer Date: 15.12.2016 Decision :Deferred. 237

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

RESEARCH LABORATORIES LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision : Information called for from the firm in NC meeting No.05/AM17 dated 08.06.2016

238

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

ORGANIC INDUSTRIES LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 239

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

ORGANIC INDUSTRIES LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 240

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

LABORATORIES Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision : Information called for from the firm in NC meeting No.07/AM17 dated 07.07.2016 241

Case No.:80/13/82-ALC4/2016 Party Name:PORUS

LABORATORIES PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00708/AM17/ RLA File :09/24/040/00509/AM16/ Lic.No/Date:0910063036 28.12.2015 Defer Date: 15.12.2016 Decision :Deferred. 242

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

Party Name:CADILA Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00181/AM17/ RLA File :08/24/040/00333/AM16/ Lic.No/Date:0810136798 29.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/193/2016-PI(Norms) dated 30.09.2016, uploaded 243

Case No.:80/20/82-ALC4/2015 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01663/AM16/ RLA File :03/95/040/00736/AM16/ Lic.No/Date:0310801389 29.12.2015 Defer Date: 15.12.2016 Decision :Deferred.

244

Case No.:81/20/82-ALC4/2015 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01664/AM16/ RLA File :03/95/040/00735/AM16/ Lic.No/Date:0310801388 29.12.2015 Defer Date: 15.12.2016 Decision :Deferred. 245

Case No.:22/20/82-ALC4/2015 Party Name:S M B

CORPORATION OF INDIA Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01605/AM16/ RLA File :03/95/040/00738/AM16/ Lic.No/Date:0310801409 30.12.2015 Defer Date: 15.12.2016 Decision :Deferred. 246

Case No.:84/20/82-ALC4/2015 Party Name:SIRMAXO

CHEMICALS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/01667/AM16/ RLA File :03/95/040/00730/AM16/ Lic.No/Date:0310801411 30.12.2015 Defer Date: its meeting No.20/82 dated 29.08.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 247

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

PLASTICIZERS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 248

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

Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision : Information called for from the firm in NC meeting No.07/AM17 dated 07.07.2016 249

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

SCIENCES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01682/AM16/ RLA File :05/23/040/00389/AM16/ Lic.No/Date:0510397158 31.12.2015 Defer Date: 15.12.2016 Decision :Deferred. 250 Case No.:101/20/82- ALC4/2015 Party Name:SONGWON SPECIALTY CHEMICALS Meet No/Date:13/82- ALC4/2016 Status: Deferred

INDIA PVT. LTD. 16.11.2016 HQ File :01/82/050/01684/AM16/ RLA File :34/24/040/00226/AM16/ Lic.No/Date:3410041775 31.12.2015 Defer Date: 15.12.2016 Decision :Deferred. 251

Case No.:119/20/82-

ALC4/2015 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 252

Case No.:104/20/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 253

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

INDUSTRIES PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01665/AM16/ RLA File :03/95/040/00750/AM16/ Lic.No/Date:0310801522 04.01.2016 Defer Date: 15.12.2016 Decision :Deferred. 254

Case No.:83/20/82-ALC4/2015 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01666/AM16/ RLA File :03/95/040/00749/AM16/ Lic.No/Date:0310801521 04.01.2016 Defer Date: 15.12.2016 Decision :Deferred. 255

Case No.:105/20/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 256

Case No.:78/20/82-ALC4/2015 Party Name:UPL

LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01661/AM16/ RLA File :03/95/040/00652/AM16/ Lic.No/Date:0310801554 05.01.2016 Defer Date: 15.12.2016 Decision :Deferred.

257

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

Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 258

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

Party Name:PRIVI ORGANICS LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 259

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

PVT. LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 260

Case No.:103/20/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01686/AM16/ RLA File :05/23/040/00404/AM16/ Lic.No/Date:0510397232 07.01.2016 Defer Date: 15.12.2016 Decision :Deferred. 261

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

Party Name:MEDISPRAY LABORATORIES PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision : Information called for from the firm in NC meeting No.11/AM17 dated 07.09.2016 262

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

Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01806/AM16/ RLA File :05/24/040/00431/AM16/ Lic.No/Date:0510397230 07.01.2016 Defer Date: 15.12.2016 Decision :Deferred. 263

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

PHARMA PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016

Decision : Information called for from the firm in NC meeting No.07/AM17 dated 07.07.2016 264

Case No.:79/20/82-ALC4/2015 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01662/AM16/ RLA File :03/95/040/00765/AM16/ Lic.No/Date:0310801655 08.01.2016 Defer Date: 15.12.2016 Decision :Deferred. 265

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

SCIENCES PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 266

Case No.:60/1/82-ALC1/2016

Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/01834/AM16/ RLA File :03/94/040/00828/AM16/ Lic.No/Date:0310801732 12.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/25/2016-PI(Norms) dated 08.09.2016, uploaded 267

Case No.:61/1/82-ALC1/2016

Party Name:BDR PHARMACEUTICALS Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/01835/AM16/ RLA File :03/94/040/00820/AM16/ Lic.No/Date:0310801731 12.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/24/2016-PI(Norms) dated 08.09.2016, uploaded 268

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

Party Name:INDO AMINES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred 269

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

Party Name:PRIVI ORGANICS LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016

Decision :Deferred. 270

Case No.:62/1/82-ALC1/2016

Party Name:BDR PHARMACEUTICALS Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01836/AM16/ RLA File :03/94/040/00833/AM16/ Lic.No/Date:0310801811 15.01.2016 Defer Date: 15.12.2016 Decision :Deferred. 271

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

Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 272

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

Party Name:PRIVI ORGANICS LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 273

Case No.:63/1/82-ALC1/2016

Party Name:BDR PHARMACEUTICALS Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/01837/AM16/ RLA File :03/94/040/00846/AM16/ Lic.No/Date:0310801882 19.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/26/2016-PI(Norms) dated 08.09.2016, uploaded 274

Case No.:65/1/82-ALC1/2016

Party Name:BDR PHARMACEUTICALS Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/01839/AM16/ RLA File :03/94/040/00857/AM16/ Lic.No/Date:0310801883 19.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/25/2016-PI(Norms) dated 08.09.2016, uploaded 275

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

Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01833/AM16/ RLA File :03/94/040/00589/AM16/ Lic.No/Date:0310801896 19.01.2016 Defer Date: 15.12.2016

Decision : Information called for from the firm in NC meeting No.05/AM17 dated 08.06.2016 276

Case No.:114/20/82-

ALC4/2015 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 277

Case No.:77/1/82-ALC1/2016

Party Name:MEDISPRAY LABORATORIES PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01851/AM16/ RLA File :03/95/040/00657/AM16/ Lic.No/Date:0310801888 19.01.2016 Defer Date: 15.12.2016 278

Case No.:76/1/82-ALC1/2016

Party Name:TITAN LABORATORIES PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/01850/AM16/ RLA File :03/95/040/00790/AM16/ Lic.No/Date:0310801892 19.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/27/2016-PI(Norms) dated 08.09.2016, uploaded 279

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

Party Name:AMINES & Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 280

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

Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01842/AM16/ RLA File :03/94/040/00834/AM16/ Lic.No/Date:0310801927 20.01.2016 Defer Date: 15.12.2016 Decision :Deferred. 281

Case No.:106/20/82-

ALC4/2015 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision : Information called for from the firm in NC meeting No.05/AM17 dated 08.06.2016

282

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

Party Name:SURVIVAL Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 283

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

Party Name:AMINES & Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 284

Case No.:47/1/82-ALC1/2016

Party Name:BDR PHARMACEUTICALS Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/01821/AM16/ RLA File :03/94/040/00864/AM16/ Lic.No/Date:0310801994 22.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/31/2016-PI(Norms) dated 03.11.2016, uploaded 285

Case No.:67/1/82-ALC1/2016

Party Name:INDOCO REMEDIES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01841/AM16/ RLA File :03/94/040/00880/AM16/ Lic.No/Date:0310802014 22.01.2016 Defer Date: 15.12.2016 286

Case No.:24/1/82-ALC1/2016

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01798/AM16/ RLA File :04/24/040/00210/AM16/ Lic.No/Date:0410161548 22.01.2016 Defer Date: 15.12.2016 Decision : Information called for from the firm in NC meeting No.07/AM17 dated 07.07.2016 287

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

Party Name:OGENE SYSTEMS INDIA LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred.

288

Case No.:97/20/82-ALC4/2015 Party Name:SHREE BANKEY

BEHARI LAL AROMATICS Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01680/AM16/ RLA File :05/24/040/00522/AM16/ Lic.No/Date:0510397405 22.01.2016 Defer Date: 15.12.2016 Decision :Deferred. 289

Case No.:96/20/82-ALC4/2015 Party Name:WEST BENGAL

CHEMICAL INDUSTRIES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01679/AM16/ RLA File :02/24/040/00178/AM16/ Lic.No/Date:0210206458 22.01.2016 Defer Date: 15.12.2016 Decision :Deferred. 290

Case No.:51/1/82-ALC1/2016

Party Name:BDR PHARMACEUTICALS Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/01825/AM16/ RLA File :03/94/040/00877/AM16/ Lic.No/Date:0310802029 25.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/32/2016-PI(Norms) dated 09.11.2016, uploaded 291

Case No.:52/1/82-ALC1/2016

Party Name:INDO AMINES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01826/AM16/ RLA File :03/94/040/00888/AM16/ Lic.No/Date:0310802024 25.01.2016 Defer Date: 15.12.2016 Decision :Deferred. 292

Case No.:89/7/82-ALC4/2016

Party Name:GLAND PHARMA LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00263/AM17/ RLA File :09/24/040/00623/AM16/ Lic.No/Date:0910063196 29.01.2016 Defer Date: 15.12.2016 293

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

Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00262/AM17/ RLA File :09/24/040/00304/AM16/ Lic.No/Date:0910063190 29.01.2016 Defer Date: 15.12.2016 Decision :Deferred. 294

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

Party Name:BODAL CHEMICALS LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 295

Case No.:44/1/82-ALC1/2016

Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01818/AM16/ RLA File :03/94/040/00886/AM16/ Lic.No/Date:0310802172 02.02.2016 Defer Date: 15.12.2016 Decision :Deferred. 296

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

Party Name:MAGNOLIA LIMITED. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 297

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

Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00162/AM17/ RLA File :05/24/040/00537/AM16/ Lic.No/Date:0510397479 03.02.2016 Defer Date: 15.12.2016 Decision :Deferred. 298

Case No.:35/1/82-ALC1/2016

Party Name:EMCURE Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01809/AM16/ RLA File :31/82/040/00270/AM16/ Lic.No/Date:3110065907 04.02.2016 Defer Date: 15.12.2016 Decision :Deferred for want of comments from DoP. 299

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

Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 300

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

Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 301 Case No.:58/1/82-ALC1/2016 Party Name:SURVIVAL Meet No/Date:13/82- Status:

ALC4/2016 16.11.2016 Deferred HQ File :01/82/050/01832/AM16/ RLA File :03/95/040/00819/AM16/ Lic.No/Date:0310802266 05.02.2016 Defer Date: 15.12.2016 Decision :Deferred. 302

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

Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 303

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

Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/01848/AM16/ RLA File :03/94/040/00810/AM16/ Lic.No/Date:0310802333 08.02.2016 Defer Date: its meeting No.20/82 dated 16.01.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 304

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

Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 305

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

Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision : 306

Case No.:70/1/82-ALC1/2016

Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/01844/AM16/ RLA File :03/94/040/00935/AM16/ Lic.No/Date:0310802452 10.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/783/2015-PI(Norms) dated 22.08.2016, uploaded 307 Case No.:79/7/82-ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 Status: Deferred

16.11.2016 HQ File :01/82/050/00253/AM17/ RLA File :09/24/040/00586/AM16/ Lic.No/Date:0910063240 10.02.2016 Defer Date: 15.12.2016 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. 308

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

Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 309

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

Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 310

Case No.:77/7/82-ALC4/2016

Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00251/AM17/ RLA File :09/24/040/00664/AM16/ Lic.No/Date:0910063251 11.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/205/2016-PI(Norms) dated 17.10.2016, uploaded 311

Case No.:73/1/82-ALC1/2016

Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/01847/AM16/ RLA File :03/94/040/00953/AM16/ Lic.No/Date:0310802552 12.02.2016 Defer Date: its meeting No.09/82 dated 31.05.2011, 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. 312

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

Party Name:UMA ENTERPRISE Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 313 Case No.:56/1/82-ALC1/2016 Party Name:ZIM Meet No/Date:13/82- Status:

LABORATORIES LTD. ALC4/2016 16.11.2016 Deferred HQ File :01/82/050/01830/AM16/ RLA File :03/95/040/00887/AM16/ Lic.No/Date:0310802649 16.02.2016 Defer Date: 15.12.2016 Decision : The Committee decided based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/194/2016-PI(Norms) dated 13.10.2016, uploaded at the end of these minutes decided to call for information from the firm. 314

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

Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 315

Case No.:57/1/82-ALC1/2016

Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/01831/AM16/ RLA File :03/95/040/00895/AM16/ Lic.No/Date:0310802676 17.02.2016 Defer Date: 15.12.2016 Decision :Deferred. 316

Case No.:56/1/83-ALC1/2016

Party Name:ORCH LABORATORIES INDIA PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/83/050/00905/AM16/ RLA File :09/24/040/00692/AM16/ Lic.No/Date:0910063297 19.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/269/2016-PI(Norms) dated 08.09.2016, uploaded 317

Case No.:87/7/82-ALC4/2016

Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00261/AM17/ RLA File :09/24/040/00696/AM16/ Lic.No/Date:0910063310 22.02.2016 Defer Date: 15.12.2016 Decision :Deferred. 318

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

Party Name:VIVIMED LABS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00252/AM17/ RLA File :09/24/040/00592/AM16/ Lic.No/Date:0910063303 22.02.2016 Defer Date: 15.12.2016 Decision :Deferred. 319

Case No.:116/7/82-ALC4/2016 Party Name:THEON

PHARMACEUTICALS LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred

HQ File :01/82/050/00290/AM17/ RLA File :22/24/040/00111/AM16/ Lic.No/Date:2210015421 26.02.2016 Defer Date: 15.12.2016 Decision :Deferred. 320

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

Party Name:MEDICLONE BIO-TECH PRIVATE LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00186/AM17/ RLA File :04/24/040/00250/AM16/ Lic.No/Date:0410161677 01.03.2016 Defer Date: 15.12.2016 321

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

Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision : The Committee noted that information called for from the firm by NC in its meeting No.09/82 dated 10.08.2016 is awaited. The Committee accordingly decided to await the reply from the firm and deferred the case. 322

Case No.:119/7/82-ALC4/2016 Party Name:THEON

Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00293/AM17/ RLA File :22/24/040/00121/AM16/ Lic.No/Date:2210015426 04.03.2016 Defer Date: 15.12.2016 323

Case No.:118/7/82-ALC4/2016 Party Name:CHIROS

PHARMA Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00292/AM17/ RLA File :22/24/040/00114/AM16/ Lic.No/Date:2210015440 09.03.2016 Defer Date: 15.12.2016 324

Case No.:120/7/82-ALC4/2016 Party Name:CHIROS

PHARMA Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00294/AM17/ RLA File :22/24/040/00113/AM16/ Lic.No/Date:2210015441 09.03.2016 Defer Date: 15.12.2016 325

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

Party Name:RUCHI SOYA INDUSTRIES LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred.

326

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

Party Name:SCOPE CHEMICALS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 327

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

CHEMICALS PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 328

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

Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 329

Case No.:14/1/82-ALC1/2016

Party Name:DIVIS LABORATORIES LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/01788/AM16/ RLA File :09/24/040/00716/AM16/ Lic.No/Date:0910063414 15.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/174/2016-PI(Norms) dated 08.09.2016, uploaded 330

Case No.:110/7/82-ALC4/2016 Party Name:TIDE

INDUSTRIES Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00284/AM17/ RLA File :34/24/040/00338/AM16/ Lic.No/Date:3410041981 16.03.2016 Defer Date: C&PU.O.No.14010/40/2011-Ch-II dated 04.03.2016, 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. 331

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

STERITECH PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00281/AM17/ RLA File :34/24/040/00345/AM16/ Lic.No/Date:3410041995 21.03.2016 Defer Date: 15.12.2016

332

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

CHEM PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 333

Case No.:111/7/82-ALC4/2016 Party Name:SHIVA

PHARMACHEM LTD, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00285/AM17/ RLA File :34/24/040/00346/AM16/ Lic.No/Date:3410041992 21.03.2016 Defer Date: 15.12.2016 Decision :Deferred. 334

Case No.:122/7/82-ALC4/2016 Party Name:BENZO CHEM

INDUSTRIES PRIVATE LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00296/AM17/ RLA File :03/94/040/01019/AM16/ Lic.No/Date:0310803499 22.03.2016 Defer Date: 15.12.2016 Decision :Deferred. 335

Case No.:48/4/82-ALC4/2016

Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00111/AM17/ RLA File :03/94/040/01067/AM16/ Lic.No/Date:0310803525 23.03.2016 Defer Date: 15.12.2016 Decision :Deferred. 336

Case No.:57/7/82-ALC4/2016

Party Name:CHIROS PHARMA Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00231/AM17/ RLA File :22/24/040/00125/AM16/ Lic.No/Date:2210015455 23.03.2016 Defer Date: 15.12.2016 337

Case No.:61/7/82-ALC4/2016

Party Name:CHIROS PHARMA Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00235/AM17/ RLA File :22/24/040/00127/AM16/ Lic.No/Date:2210015457 23.03.2016 Defer Date: 15.12.2016 338

Case No.:62/7/82-ALC4/2016

Party Name:CHIROS PHARMA Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00236/AM17/ RLA File :22/24/040/00128/AM16/ Lic.No/Date:2210015456 23.03.2016 Defer Date: 15.12.2016

339

Case No.:85/1/82-ALC1/2016

Party Name:DIVIS LABORATORIES LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/01859/AM16/ RLA File :09/24/040/00730/AM16/ Lic.No/Date:0910063440 23.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/209/2016-PI(Norms) dated 08.09.2016, uploaded 340

Case No.:60/11/82-ALC4/2016 Party Name:GRANULES

INDIA LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00594/AM17/ RLA File :09/24/040/00759/AM16/ Lic.No/Date:0910063450 29.03.2016 Defer Date: 15.12.2016 341

Case No.:5/7/82-ALC4/2016

Party Name:CADILA Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00179/AM17/ RLA File :08/24/040/00466/AM16/ Lic.No/Date:0810137553 30.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/190/2016-PI(Norms) dated 30.09.2016, uploaded 342

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

Party Name:POSY PHARMACHEM PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00213/AM17/ RLA File :08/24/040/00426/AM16/ Lic.No/Date:0810137551 30.03.2016 Defer Date: 15.12.2016 343

Case No.:58/7/82-ALC4/2016

Party Name:VENUS REMEDIES LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00232/AM17/ RLA File :22/24/040/00133/AM16/ Lic.No/Date:2210015463 31.03.2016 Defer Date: 15.12.2016 344

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

LABORATORIES LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016

345

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

& PHARMACEUTICALS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00615/AM17/ RLA File :03/94/040/01096/AM16/ Lic.No/Date:0310803709 01.04.2016 Defer Date: 15.12.2016 346

Case No.:103/7/82-ALC4/2016 Party Name:JUBILANT

GENERICS LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File:01/82/050/00 277/ AM17/ RLA File :05/23/040/00555/AM16/ Lic.No/Date:0510398126 01.04.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/191/2016-PI(Norms) dated 30.09.2016, uploaded 347

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

GENERICS LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00278/AM17/ RLA File :05/23/040/00556/AM16/ Lic.No/Date:0510398125 01.04.2016 Defer Date: 15.12.2016 Decision :Deferred. 348

Case No.:121/7/82-ALC4/2016 Party Name:VARUN

MEDIMPEX INC. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00295/AM17/ RLA File :05/24/040/00632/AM16/ Lic.No/Date:0510398119 01.04.2016 Defer Date: 15.12.2016 Decision :Deferred. 349

Case No.:4/7/82-ALC4/2016

Party Name:CADILA Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00178/AM17/ RLA File :08/24/040/00001/AM17/ Lic.No/Date:0810137612 05.04.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/195/2016-PI(Norms) dated 13.10.2016, uploaded 350

Case No.:6/7/82-ALC4/2016

Party Name:CADILA Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00180/AM17/ RLA File :08/24/040/00470/AM16/ Lic.No/Date:0810137611 05.04.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/164/2016-PI(Norms) dated 13.10.2016, uploaded

351

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

Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 352

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

Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00212/AM17/ RLA File :05/23/040/00571/AM16/ Lic.No/Date:0510398134 05.04.2016 Defer Date: 15.12.2016 353

Case No.:105/7/82-ALC4/2016 Party Name:JODAS EXPOIM

PVT.LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00279/AM17/ RLA File :05/23/040/00573/AM16/ Lic.No/Date:0510398133 05.04.2016 Defer Date: 15.12.2016 354

Case No.:106/7/82-ALC4/2016 Party Name:JODAS EXPOIM

PVT.LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00280/AM17/ RLA File :05/23/040/00570/AM16/ Lic.No/Date:0510398132 05.04.2016 Defer Date: 15.12.2016 355

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

INDUSTRIES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00297/AM17/ RLA File :03/94/040/01038/AM16/ Lic.No/Date:0310803819 06.04.2016 Defer Date: 15.12.2016 356

Case No.:42/7/82-

ALC4/2016 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00216/AM17/ RLA File :34/24/040/00325/AM16/ Lic.No/Date:3410042036 07.04.2016 Defer Date: 15.12.2016 357

Case No.:43/7/82-ALC4/2016

Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred

HQ File :01/82/050/00217/AM17/ RLA File :34/24/040/00355/AM16/ Lic.No/Date:3410042037 07.04.2016 Defer Date: 15.12.2016 358

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

Party Name:FINE CURE Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 359

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

Party Name:ASTRAL STERITECH PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 360

Case No.:87/11/82-ALC4/2016 Party Name:KLJ

PLASTICIZERS LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00621/AM17/ RLA File :05/23/040/00554/AM16/ Lic.No/Date:0510398217 13.04.2016 Defer Date: 15.12.2016 Decision :Deferred. 361

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

Party Name:BODAL CHEMICALS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 362

Case No.:33/7/82-ALC4/2016

Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00207/AM17/ RLA File :05/23/040/00018/AM17/ Lic.No/Date:0510398279 22.04.2016 Defer Date: 15.12.2016 363

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

Party Name:SUPREET CHEMICALS PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 364 Case No.:125/7/82-ALC4/2016 Party Name:YASHO Meet No/Date:13/82- Status:

INDUSTRIES PVT.LTD. ALC4/2016 16.11.2016 Deferred HQ File :01/82/050/00299/AM17/ RLA File :03/95/040/00061/AM17/ Lic.No/Date:0310804144 25.04.2016 Defer Date: 15.12.2016 Decision :Deferred. 365

Case No.:126/7/82-ALC4/2016 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00300/AM17/ RLA File :03/95/040/00064/AM17/ Lic.No/Date:0310804154 25.04.2016 Defer Date: 15.12.2016 Decision :Deferred. 366

Case No.:145/7/82-ALC4/2016 Party Name:ENCUBE

ETHICALS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00319/AM17/ RLA File :03/94/040/00072/AM17/ Lic.No/Date:0310804202 26.04.2016 Defer Date: 15.12.2016 367

Case No.:144/7/82-ALC4/2016 Party Name:GOLD STAR

CHEMICALS PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00318/AM17/ RLA File :03/94/040/01042/AM16/ Lic.No/Date:0310804172 26.04.2016 Defer Date: 15.12.2016 Decision :Deferred. 368

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

CHEM PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 369

Case No.:127/7/82-ALC4/2016 Party Name:METROPOLITAN

EXIMCHEM PRIVATE LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00301/AM17/ RLA File :03/95/040/00048/AM17/ Lic.No/Date:0310804183 26.04.2016 Defer Date: 15.12.2016 Decision :Deferred. 370

Case No.:128/7/82-ALC4/2016 Party Name:METROPOLITAN

EXIMCHEM PRIVATE LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00302/AM17/ RLA File :03/95/040/00049/AM17/ Lic.No/Date:0310804184 26.04.2016 Defer Date: 15.12.2016 Decision :Deferred.

371

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

Party Name:HELLO PAINTS (P) LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00206/AM17/ RLA File :05/23/040/00036/AM17/ Lic.No/Date:0510398321 27.04.2016 Defer Date: 15.12.2016 Decision :Deferred. 372

Case No.:130/7/82-ALC4/2016 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00304/AM17/ RLA File :03/95/040/00068/AM17/ Lic.No/Date:0310804238 27.04.2016 Defer Date: 15.12.2016 Decision :Deferred. 373

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

PHARMACEUTICALS Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 374

Case No.:147/7/82-ALC4/2016 Party Name:BENZO CHEM

INDUSTRIES PRIVATE LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00321/AM17/ RLA File :03/94/040/00063/AM17/ Lic.No/Date:0310804284 29.04.2016 Defer Date: 15.12.2016 Decision :Deferred. 375

Case No.:143/7/82-ALC4/2016 Party Name:GLENMARK

Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00317/AM17/ RLA File :03/94/040/00064/AM17/ Lic.No/Date:0310804295 29.04.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/188/2016-PI(Norms) dated 18.10.2016, uploaded 376

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

RESEARCH LABORATORIES LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision : The Committee noted that information called for from the firm by NC in its meeting No.11/82 dated

07.09.2016 is awaited. The Committee accordingly decided to await the reply from the firm and deferred the case.

377

Case No.:129/7/82-ALC4/2016 Party Name:NEW ALLIANCE

DYE-CHEM PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00303/AM17/ RLA File :03/95/040/00004/AM17/ Lic.No/Date:0310804339 02.05.2016 Defer Date: 15.12.2016 Decision :Deferred. 378

Case No.:14/7/82-ALC4/2016

Party Name:CADILA HEALTHCARE LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00188/AM17/ RLA File :08/24/040/00035/AM17/ Lic.No/Date:0810137832 03.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/166/2016-PI(Norms) dated 26.09.2016, uploaded 379

Case No.:75/7/82-ALC4/2016

Party Name:ALKALOIDS CORPORATION Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00249/AM17/ RLA File :02/24/040/00016/AM17/ Lic.No/Date:0210206661 04.05.2016 Defer Date: 15.12.2016 Decision :Deferred. 380

Case No.:21/7/82-ALC4/2016

Party Name:CADILA HEALTHCARE LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00195/AM17/ RLA File :08/24/040/00049/AM17/ Lic.No/Date:0810137835 04.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/189/2016-PI(Norms) dated 30.09.2016, uploaded 381

Case No.:6/11/82-ALC4/2016

Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00540/AM17/ RLA File :09/24/040/00052/AM17/ Lic.No/Date:0910063584 05.05.2016 Defer Date: 15.12.2016 382

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

Party Name:PANACEA BIOTEC LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 383 Case No.:8/7/82-ALC4/2016 Party Name:STRIDES Meet No/Date:13/82- Status:

SHASUN LIMITED ALC4/2016 16.11.2016 Deferred HQ File :01/82/050/00182/AM17/ RLA File :04/24/040/00009/AM17/ Lic.No/Date:0410161871 05.05.2016 Defer Date: 15.12.2016 Decision : The Committee noted that information called for from the firm by NC in its meeting No.11/82 dated 07.09.2016 is awaited. The Committee accordingly decided to await the reply from the firm and deferred the case. 384

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

Party Name:STRIDES SHASUN LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision : The Committee noted that information called for from the firm by NC in its meeting No.11/82 dated 07.09.2016 is awaited. The Committee accordingly decided to await the reply from the firm and deferred the case. 385

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

Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 386

Case No.:141/7/82-ALC4/2016 Party Name:BENZO CHEM

INDUSTRIES PRIVATE LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00315/AM17/ RLA File :03/94/040/00041/AM17/ Lic.No/Date:0310804465 09.05.2016 Defer Date: 15.12.2016 Decision :Deferred. 387

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

Party Name:CONTINENTAL CHEMICALS Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00191/AM17/ RLA File :08/24/040/00045/AM17/ Lic.No/Date:0810137878 09.05.2016 Defer Date: 15.12.2016 Decision :Deferred. 388

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

Party Name:CONTINENTAL CHEMICALS Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 389

Case No.:161/7/82-ALC4/2016 Party Name:GITANJALI

CHEMICALS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred

HQ File :01/82/050/00335/AM17/ RLA File :03/94/040/00026/AM17/ Lic.No/Date:0310804504 09.05.2016 Defer Date: 15.12.2016 Decision :Deferred. 390

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

Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 391

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

ORGANICS PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 392

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

ORGANICS PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 393

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

Party Name:FRESENIUS Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 394

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

INDUSTRIES LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 395

Case No.:84/11/82-ALC4/2016 Party Name:NEULAND

LABORATORIES LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00618/AM17/ RLA File :09/24/040/00039/AM17/ Lic.No/Date:0910063615 11.05.2016 Defer Date: 15.12.2016 396 Case No.:157/7/82-ALC4/2016 Party Name:APEX PHARMA, Meet No/Date:13/82- Status:

ALC4/2016 16.11.2016 Deferred HQ File :01/82/050/00331/AM17/ RLA File :03/94/040/00122/AM17/ Lic.No/Date:0310804628 12.05.2016 Defer Date: 15.12.2016 397

Case No.:74/7/82-ALC4/2016

Party Name:KLJ Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00248/AM17/ RLA File :05/23/040/00050/AM17/ Lic.No/Date:0510398481 12.05.2016 Defer Date: 15.12.2016 Decision :Deferred. 398

Case No.:158/7/82-ALC4/2016 Party Name:KUBO

COMBUSTION EFFICIENCY CHEMICALS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00332/AM17/ RLA File :03/94/040/01064/AM16/ Lic.No/Date:0310804642 12.05.2016 Defer Date: 15.12.2016 Decision :Deferred. 399

Case No.:131/7/82-ALC4/2016 Party Name:NEW ALLIANCE

DYE-CHEM PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00305/AM17/ RLA File :03/95/040/00016/AM17/ Lic.No/Date:0310804666 13.05.2016 Defer Date: 15.12.2016 Decision :Deferred. 400

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

PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 401

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

LABORATORIES PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 402

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

PHARMA PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016

403

Case No.:54/7/82-ALC4/2016

Party Name:FRESENIUS Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00228/AM17/ RLA File :05/23/040/00064/AM17/ Lic.No/Date:0510398544 18.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/171/2016-PI(Norms) dated 30.09.2016, uploaded 404

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

LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 405

Case No.:53/7/82-ALC4/2016

Party Name:CADILA Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00227/AM17/ RLA File :08/24/040/00069/AM17/ Lic.No/Date:0810137950 19.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/194/2016-PI(Norms) dated 13.10.2016, uploaded 406

Case No.:1/5/82-ALC4/2016

Party Name:RA CHEM PHARMA LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00160/AM17/ RLA File :09/24/040/00083/AM17/ Lic.No/Date:0910063660 20.05.2016 Defer Date: its meeting No.2/82 dated 24.04.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 407

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

Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 408

Case No.:156/7/82-ALC4/2016 Party Name:AMINES &

Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00330/AM17/ RLA File :03/94/040/00147/AM17/ Lic.No/Date:0310804903 23.05.2016 Defer Date: 15.12.2016

Decision :Defered. 409

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

CHEMICALS (P) LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 410

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

CHEMICALS (P) LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 411

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

CROPSCIENCE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 412

Case No.:152/7/82-ALC4/2016 Party Name:BENZO CHEM

INDUSTRIES PRIVATE LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00326/AM17/ RLA File :03/94/040/00152/AM17/ Lic.No/Date:0310804950 24.05.2016 Defer Date: 15.12.2016 Decision :Deferred. 413

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

SCIENCE PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 414

Case No.:88/11/82-ALC4/2016 Party Name:ESTEEM

INDUSTRIES PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00622/AM17/ RLA File :17/24/040/00027/AM17/ Lic.No/Date:1710006342 26.05.2016 Defer Date: 15.12.2016 Decision :Deferred. 415

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

Party Name:MANALI PETROCHEMICALS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 416

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

Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00535/AM17/ RLA File :05/23/040/00110/AM17/ Lic.No/Date:0510398726 03.06.2016 Defer Date: 15.12.2016 417

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

Party Name:SOFTGEL HEALTH CARE PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 418

Case No.:61/11/82-ALC4/2016 Party Name:KEKULE

PHARMA LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00595/AM17/ RLA File :09/24/040/00017/AM17/ Lic.No/Date:0910063781 09.06.2016 Defer Date: 15.12.2016 419

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

CHEMICAL INDUSTRIES LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00657/AM17/ RLA File :34/24/040/00068/AM17/ Lic.No/Date:3410042260 10.06.2016 Defer Date: 15.12.2016 Decision :Deferred. 420

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

CHEMICALS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 421

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

CHEMICALS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 422 Case No.:89/13/82-ALC4/2016 Party Name:UMA Meet No/Date:13/82- Status:Case

ENTERPRISE ALC4/2016 16.11.2016 Deferred HQ File :01/82/050/00717/AM17/ RLA File :08/24/040/00099/AM17/ Lic.No/Date:0810138154 10.06.2016 Defer Date: 15.12.2016 Decision :Deferred. 423

Case No.:6/13/82-ALC4/2016

Party Name:MELZER CHEMICALS PVT. LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00634/AM17/ RLA File :31/83/040/00023/AM17/ Lic.No/Date:3110066173 13.06.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat based on the earlier decision taken by NC in its meeting No.04/82 dated 16.05.2013, 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. 424

Case No.:3/11/82-ALC4/2016

Party Name:DANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00537/AM17/ RLA File :03/94/040/00151/AM17/ Lic.No/Date:0310805608 20.06.2016 Defer Date: 15.12.2016 Decision :Deferred. 425

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

Party Name:NEULAND LABORATORIES LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00175/AM17/ RLA File :09/24/040/00139/AM17/ Lic.No/Date:0910063809 21.06.2016 Defer Date: 15.12.2016 426

Case No.:30/13/82-ALC4/2016 Party Name:ESTEEM

INDUSTRIES PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00658/AM17/ RLA File :17/24/040/00050/AM17/ Lic.No/Date:1710006371 24.06.2016 Defer Date: 15.12.2016 Decision :Deferred. 427

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

Party Name:ASCENT FINECHEM PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00539/AM17/ RLA File :08/24/040/00104/AM17/ Lic.No/Date:0810138218 28.06.2016 Defer Date: 15.12.2016 Decision :Deferred. 428

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

VITAMINS PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 429

Case No.:44/11/82-ALC4/2016 Party Name:GLENMARK

Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00578/AM17/ RLA File :03/94/040/00243/AM17/ Lic.No/Date:0310805848 30.06.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/188/2016-PI(Norms) dated 18.10.2016, uploaded 430

Case No.:49/11/82-ALC4/2016 Party Name:GLENMARK

Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00583/AM17/ RLA File :03/94/040/00253/AM17/ Lic.No/Date:0310805837 30.06.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/188/2016-PI(Norms) dated 18.10.2016, uploaded 431

Case No.:45/11/82-ALC4/2016 Party Name:KUBO

COMBUSTION EFFICIENCY CHEMICALS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00579/AM17/ RLA File :03/94/040/00249/AM17/ Lic.No/Date:0310805832 30.06.2016 Defer Date: 15.12.2016 Decision :Deferred. 432

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

Party Name:PANERA BIOTEC PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision : Deferred for want of comments from DBT. 433

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

PAINTS AND CHEMICALS PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 434

Case No.:50/11/82-ALC4/2016 Party Name:ENCUBE

ETHICALS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File RLA File Lic.No/Date:0310805959 Defer Date:

:01/82/050/00584/AM17/ :03/94/040/00275/AM17/ 05.07.2016 15.12.2016 435

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

ETHICALS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 436

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

& PHARMACEUTICALS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 437

Case No.:15/11/82-ALC4/2016 Party Name:N S CHEMICALS

Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00549/AM17/ RLA File :03/95/040/00119/AM17/ Lic.No/Date:0310805965 05.07.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.01/82 dated 10.04.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 438

Case No.:38/13/82-ALC4/2016 Party Name:SAURAV

CHEMICALS LTD, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00666/AM17/ RLA File :22/24/040/00031/AM17/ Lic.No/Date:2210015515 05.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/216/2016-PI(Norms) dated 21.10.2016, uploaded 439

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

Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00631/AM17/ RLA File :05/24/040/00143/AM17/ Lic.No/Date:0510399022 06.07.2016 Defer Date: 15.12.2016 440

Case No.:36/13/82-ALC4/2016 Party Name:DSM SINOCHEM

PHARMACEUTICALS INDIA PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:2210015519 Defer Date:

:01/82/050/00664/AM17/ :22/24/040/00030/AM17/ 08.07.2016 15.12.2016 441

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

INTERMEDIATES PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00667/AM17/ RLA File :52/24/040/00022/AM17/ Lic.No/Date:5210041951 08.07.2016 Defer Date: 15.12.2016 Decision :Deferred. 442

Case No.:12/11/82-ALC4/2016 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00546/AM17/ RLA File :03/95/040/00285/AM17/ Lic.No/Date:0310806007 08.07.2016 Defer Date: 15.12.2016 443

Case No.:28/13/82-ALC4/2016 Party Name:CAMPHOR &

ALLIED PRODUCTS LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00656/AM17/ RLA File :03/94/040/00997/AM16/ Lic.No/Date:0310806094 11.07.2016 Defer Date: 15.12.2016 Decision :Deferred. 444

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

Party Name:FRESENIUS Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00629/AM17/ RLA File :05/23/040/00168/AM17/ Lic.No/Date:0510399049 11.07.2016 Defer Date: 15.12.2016 445

Case No.:37/13/82-ALC4/2016 Party Name:NECTAR

LIFESCIENCES LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00665/AM17/ RLA File :22/24/040/00029/AM17/ Lic.No/Date:2210015520 11.07.2016 Defer Date: 15.12.2016 446

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

VAPI PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 447 Case No.:42/11/82-ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:13/82- ALC4/2016 Status: Deferred

16.11.2016 HQ File :01/82/050/00576/AM17/ RLA File :03/94/040/00198/AM17/ Lic.No/Date:0310806121 12.07.2016 Defer Date: 15.12.2016 Decision :Deferred. 448

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

INDUSTRIES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 449

Case No.:39/11/82-ALC4/2016 Party Name:CAMPHOR &

ALLIED PRODUCTS LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00573/AM17/ RLA File :03/94/040/00966/AM16/ Lic.No/Date:0310806146 12.07.2016 Defer Date: 15.12.2016 Decision :Deferred. 450

Case No.:9/11/82-ALC4/2016

Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00543/AM17/ RLA File :03/94/040/00277/AM17/ Lic.No/Date:0310806159 12.07.2016 Defer Date: 15.12.2016 451

Case No.:24/11/82-ALC4/2016 Party Name:ENCUBE

ETHICALS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00558/AM17/ RLA File :03/94/040/00272/AM17/ Lic.No/Date:0310806154 12.07.2016 Defer Date: 15.12.2016 452

Case No.:46/11/82-ALC4/2016 Party Name:ENCUBE

ETHICALS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00580/AM17/ RLA File :03/94/040/00276/AM17/ Lic.No/Date:0310806157 12.07.2016 Defer Date: 15.12.2016 453

Case No.:47/11/82-ALC4/2016 Party Name:ENCUBE

ETHICALS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00581/AM17/ RLA File :03/94/040/00274/AM17/ Lic.No/Date:0310806156 12.07.2016 Defer Date: 15.12.2016

454

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

CHEMICALS LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 455

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

& PHARMACEUTICALS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 456

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

& PHARMACEUTICALS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00660/AM17/ RLA File :03/94/040/00291/AM17/ Lic.No/Date:0310806165 12.07.2016 Defer Date: 15.12.2016 457

Case No.:41/11/82-ALC4/2016 Party Name:KOPRAN

RESEARCH LABORATORIES LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00575/AM17/ RLA File :03/94/040/01110/AM16/ Lic.No/Date:0310806126 12.07.2016 Defer Date: 15.12.2016 458

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

OXYGEN & INDUSTRIAL GASES PVT.LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 459

Case No.:4/11/82-ALC4/2016

Party Name:ATUL LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00538/AM17/ RLA File :08/24/040/00113/AM17/ Lic.No/Date:0810138282 13.07.2016 Defer Date: 15.12.2016 Decision :Deferred. 460

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

LABORATORIES LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016

461

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

HEALTHCARE LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 462

Case No.:73/11/82-ALC4/2016 Party Name:DHANUKA

LABORATORIES LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00607/AM17/ RLA File :05/23/040/00192/AM17/ Lic.No/Date:0510399089 14.07.2016 Defer Date: 15.12.2016 463

Case No.:2/13/82-ALC4/2016

Party Name:JUBILANT GENERICS LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00630/AM17/ RLA File :05/23/040/00194/AM17/ Lic.No/Date:0510399087 14.07.2016 Defer Date: 15.12.2016 Decision :Deferred. 464

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

SCIENCES PVT.LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 465

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

CHEMICALS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 466

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

PARENTERALS PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00588/AM17/ RLA File :08/24/040/00138/AM17/ Lic.No/Date:0810138287 14.07.2016 Defer Date: 15.12.2016 467

Case No.:69/11/82-ALC4/2016 Party Name:CADILA

HEALTHCARE LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00603/AM17/ RLA File :08/24/040/00146/AM17/ Lic.No/Date:0810138302 15.07.2016 Defer Date: 15.12.2016

468

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

HEALTHCARE LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 469

Case No.:38/11/82-ALC4/2016 Party Name:GLOBE

TROTTERS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00572/AM17/ RLA File :03/94/040/00224/AM17/ Lic.No/Date:0310806304 15.07.2016 Defer Date: 15.12.2016 470

Case No.:4/13/82-ALC4/2016

Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00632/AM17/ RLA File :05/24/040/00165/AM17/ Lic.No/Date:0510399093 15.07.2016 Defer Date: 15.12.2016 471

Case No.:5/13/82-ALC4/2016

Party Name:SHREE BANKEY BEHARI LAL AROMATICS Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00633/AM17/ RLA File :05/24/040/00157/AM17/ Lic.No/Date:0510399096 15.07.2016 Defer Date: 15.12.2016 Decision :Deferred. 472

Case No.:34/11/82-ALC4/2016 Party Name:CAMPHOR &

ALLIED PRODUCTS LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00568/AM17/ RLA File :03/94/040/00114/AM17/ Lic.No/Date:0310806356 18.07.2016 Defer Date: 15.12.2016 Decision :Deferred. 473

Case No.:37/11/82-ALC4/2016 Party Name:GLOBE

TROTTERS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00571/AM17/ RLA File :03/94/040/00220/AM17/ Lic.No/Date:0310806338 18.07.2016 Defer Date: 15.12.2016 474

Case No.:36/11/82-ALC4/2016 Party Name:KOPRAN

RESEARCH LABORATORIES LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred

HQ File :01/82/050/00570/AM17/ RLA File :03/94/040/00226/AM17/ Lic.No/Date:0310806366 18.07.2016 Defer Date: 15.12.2016 475

Case No.:23/11/82-ALC4/2016 Party Name:ENCUBE

ETHICALS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00557/AM17/ RLA File :03/94/040/00301/AM17/ Lic.No/Date:0310806378 19.07.2016 Defer Date: 15.12.2016 476

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

Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 477

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

SCIENCES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00600/AM17/ RLA File :05/23/040/00147/AM17/ Lic.No/Date:0510399130 19.07.2016 Defer Date: 15.12.2016 478

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

CHEMICALS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 479

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

SPECIALTIES LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 480

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

INDUSTRIES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 481 Case No.:74/11/82-ALC4/2016 Party Name:KLJ Meet No/Date:13/82- Status:

ALC4/2016 16.11.2016 Deferred HQ File :01/82/050/00608/AM17/ RLA File :05/23/040/00195/AM17/ Lic.No/Date:0510399160 20.07.2016 Defer Date: 15.12.2016 Decision :Deferred. 482

Case No.:118/13/82-

ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00746/AM17/ RLA File :07/24/040/00129/AM17/ Lic.No/Date:0710110138 21.07.2016 Defer Date: 15.12.2016 Decision :Deferred. 483

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

PHARMACEUTICALS Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 484

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

PHARMACEUTICALS Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00711/AM17/ RLA File :03/95/040/00327/AM17/ Lic.No/Date:0310806482 21.07.2016 Defer Date: 15.12.2016 485

Case No.:25/11/82-ALC4/2016 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Deferred HQ File :01/82/050/00559/AM17/ RLA File :03/95/040/00180/AM17/ Lic.No/Date:0310806477 21.07.2016 Defer Date: 15.12.2016 Decision :Deferred. 486

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

AUXILIARIES PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 487

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

AUXILIARIES PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred.

488

Case No.:65/11/82-ALC4/2016 Party Name:DIVIS

LABORATORIES LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00599/AM17/ RLA File :09/24/040/00222/AM17/ Lic.No/Date:0910063975 22.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/174/2016-PI(Norms) dated 08.09.2016, uploaded 489

Case No.:33/11/82-ALC4/2016 Party Name:ENALTEC LABS

PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00567/AM17/ RLA File :03/94/040/00327/AM17/ Lic.No/Date:0310806514 22.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/71/2016-PI(Norms) dated 26.09.2016, uploaded 490

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

Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00648/AM17/ RLA File :05/23/040/00211/AM17/ Lic.No/Date:0510399202 22.07.2016 Defer Date: 15.12.2016 491

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

CHEMICALS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 492

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

AUXILIARIES PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 493

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

Party Name:STYRAX PHARMA PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00635/AM17/ RLA File :26/24/040/00013/AM17/ Lic.No/Date:2610012765 22.07.2016 Defer Date: 15.12.2016

494

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

PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 495

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

PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 496

Case No.:144/13/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00772/AM17/ RLA File :08/24/040/00154/AM17/ Lic.No/Date:0810138352 25.07.2016 Defer Date: 15.12.2016 497

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

AUXILIARIES PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 Decision :Deferred. 498

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

PARENTERALS PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 499

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

ETHICALS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 500

Case No.:65/13/82-ALC4/2016 Party Name:INDOCO

REMEDIES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00693/AM17/ RLA File :03/94/040/00334/AM17/ Lic.No/Date:0310806610 26.07.2016 Defer Date: 15.12.2016

501

Case No.:62/13/82-ALC4/2016 Party Name:IPCA

LABORATORIES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00690/AM17/ RLA File :03/94/040/00333/AM17/ Lic.No/Date:0310806623 26.07.2016 Defer Date: 15.12.2016 502

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

&PHARMACEUTICALS PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 503

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

&PHARMACEUTICALS PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 504

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

&PHARMACEUTICALS PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 505

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

&PHARMACEUTICALS PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 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: 15.12.2016 506

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

PHARMACEUTICALS Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00695/AM17/ RLA File :03/94/040/00335/AM17/ Lic.No/Date:0310806658 27.07.2016 Defer Date: 15.12.2016 507

Case No.:66/13/82-ALC4/2016 Party Name:BENZO CHEM

INDUSTRIES PRIVATE LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00694/AM17/ RLA File :03/94/040/00332/AM17/ Lic.No/Date:0310806661 27.07.2016 Defer Date: 15.12.2016

Decision :Deferre. 508

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

PETROCHEM PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00712/AM17/ RLA File :05/24/040/00170/AM17/ Lic.No/Date:0510399250 27.07.2016 Defer Date: 15.12.2016 Decision :Deferred. 509

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

INDUSTRIES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00692/AM17/ RLA File :03/94/040/00177/AM17/ Lic.No/Date:0310806697 28.07.2016 Defer Date: 15.12.2016 Decision :Deferred. 510

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

PHARMACEUTICALS P. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00699/AM17/ RLA File :03/94/040/00312/AM17/ Lic.No/Date:0310806768 01.08.2016 Defer Date: 15.12.2016 511

Case No.:70/13/82-ALC4/2016 Party Name:INDOCO

REMEDIES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00698/AM17/ RLA File :03/94/040/00344/AM17/ Lic.No/Date:0310806741 01.08.2016 Defer Date: 15.12.2016 512

Case No.:63/13/82-ALC4/2016 Party Name:KOPRAN

RESEARCH LABORATORIES LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00691/AM17/ RLA File :03/94/040/00280/AM17/ Lic.No/Date:0310806745 01.08.2016 Defer Date: 15.12.2016 513

Case No.:57/13/82-ALC4/2016 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00685/AM17/ RLA File :03/95/040/00367/AM17/ Lic.No/Date:0310806759 01.08.2016 Defer Date: 15.12.2016 Decision :Deferred. 514

Case No.:85/13/82-ALC4/2016 Party Name:VADIVARHE

SPECIALITY CHEMICALS LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved

HQ File :01/82/050/00713/AM17/ RLA File :03/95/040/00320/AM17/ Lic.No/Date:0310806778 02.08.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/717/2015-PI(Norms) dated 24.10.2016, uploaded 515

Case No.:35/13/82-ALC4/2016 Party Name:VENUS

REMEDIES LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00663/AM17/ RLA File :22/24/040/00036/AM17/ Lic.No/Date:2210015529 02.08.2016 Defer Date: 15.12.2016 516

Case No.:34/13/82-ALC4/2016 Party Name:AMOL

PHARMACEUTICALS PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00662/AM17/ RLA File :13/24/040/00017/AM17/ Lic.No/Date:1310048326 03.08.2016 Defer Date: 15.12.2016 517

Case No.:9/13/82-ALC4/2016

Party Name:CADILA HEALTHCARE LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00637/AM17/ RLA File :08/24/040/00175/AM17/ Lic.No/Date:0810138443 05.08.2016 Defer Date: 15.12.2016 518

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

CHEMICALS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00701/AM17/ RLA File :03/94/040/00354/AM17/ Lic.No/Date:0310806872 05.08.2016 Defer Date: 15.12.2016 519

Case No.:77/13/82-ALC4/2016 Party Name:ENALTEC LABS

PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00705/AM17/ RLA File :03/94/040/00361/AM17/ Lic.No/Date:0310806885 05.08.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.08/82 dated 11.07.2013, 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. 520

Case No.:74/13/82-ALC4/2016 Party Name:ALIVIRA

ANIMAL HEALTH LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred

HQ File :01/82/050/00702/AM17/ RLA File :03/94/040/00367/AM17/ Lic.No/Date:0310806928 08.08.2016 Defer Date: 15.12.2016 Decision :Deferred for want of comments from DBT. 521

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

HEALTHCARE PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00700/AM17/ RLA File :03/94/040/00356/AM17/ Lic.No/Date:0310806927 08.08.2016 Defer Date: 15.12.2016 522

Case No.:59/13/82-ALC4/2016 Party Name:UPL

LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00687/AM17/ RLA File :03/95/040/00998/AM16/ Lic.No/Date:0310806923 08.08.2016 Defer Date: 15.12.2016 Decision :Deferred. 523

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

LABORATORIES LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00677/AM17/ RLA File :03/94/040/01052/AM16/ Lic.No/Date:0310806947 09.08.2016 Defer Date: 15.12.2016 524

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

FINOCHEM PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00678/AM17/ RLA File :03/94/040/00286/AM17/ Lic.No/Date:0310806966 09.08.2016 Defer Date: 15.12.2016 525

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

Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00638/AM17/ RLA File :05/23/040/00229/AM17/ Lic.No/Date:0510399392 09.08.2016 Defer Date: 15.12.2016 526

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

INDIA PRIVATE LIMITED. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00676/AM17/ RLA File :03/94/040/00386/AM17/ Lic.No/Date:0310806969 09.08.2016 Defer Date: its meeting No.20/82 dated 16.01.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

527

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

ALATHUR) PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00654/AM17/ RLA File :04/24/040/00065/AM17/ Lic.No/Date:0410162171 09.08.2016 Defer Date: 15.12.2016 Decision :Deferred. 528

Case No.:8/13/82-ALC4/2016

Party Name:AKTINOS HEALTHCARE PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00636/AM17/ RLA File :09/24/040/00232/AM17/ Lic.No/Date:0910064019 10.08.2016 Defer Date: 15.12.2016 529

Case No.:54/13/82-ALC4/2016 Party Name:CAMPHOR &

ALLIED PRODUCTS LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00682/AM17/ RLA File :03/94/040/00405/AM17/ Lic.No/Date:0310807006 10.08.2016 Defer Date: 15.12.2016 Decision :Deferred. 530

Case No.:58/13/82-ALC4/2016 Party Name:SUNSHIELD

CHEMICALS LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00686/AM17/ RLA File :03/95/040/00370/AM17/ Lic.No/Date:0310807000 10.08.2016 Defer Date: 15.12.2016 Decision :Deferred. 531

Case No.:41/13/82-ALC4/2016 Party Name:VIRDEV

INTERMEDIATES PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00669/AM17/ RLA File :52/24/040/00031/AM17/ Lic.No/Date:5210041993 10.08.2016 Defer Date: 15.12.2016 Decision :Deferred. 532

Case No.:47/13/82-ALC4/2016 Party Name:GLENMARK

Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00675/AM17/ RLA File :03/94/040/00414/AM17/ Lic.No/Date:0310807048 11.08.2016 Defer Date: 15.12.2016 533

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

(P) LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00645/AM17/ RLA File :05/23/040/00220/AM17/ Lic.No/Date:0510399449 11.08.2016 Defer Date: 15.12.2016

Decision :Deferred. 534

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

PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00704/AM17/ RLA File :03/94/040/00391/AM17/ Lic.No/Date:0310807030 11.08.2016 Defer Date: 15.12.2016 Decision :Deferred. 535

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

SCIENCES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00646/AM17/ RLA File :05/23/040/00230/AM17/ Lic.No/Date:0510399442 11.08.2016 Defer Date: 15.12.2016 Decision :Deferred. 536

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

CORPORATION OF INDIA Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00689/AM17/ RLA File :03/95/040/00388/AM17/ Lic.No/Date:0310807070 11.08.2016 Defer Date: 15.12.2016 Decision :Deferred. 537

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

INDUSTRIES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00706/AM17/ RLA File :03/94/040/00371/AM17/ Lic.No/Date:0310807104 12.08.2016 Defer Date: 15.12.2016 Decision :Deferred. 538

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

HEALTHCARE LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00640/AM17/ RLA File :08/24/040/00196/AM17/ Lic.No/Date:0810138482 12.08.2016 Defer Date: 15.12.2016 539

Case No.:154/13/82-

ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00782/AM17/ RLA File :05/24/040/00231/AM17/ Lic.No/Date:0510399455 12.08.2016 Defer Date: 15.12.2016 540

Case No.:31/13/82-ALC4/2016 Party Name:PI INDUSTRIES

LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved

HQ File :01/82/050/00659/AM17/ RLA File :13/24/040/00019/AM17/ Lic.No/Date:1310048337 12.08.2016 Defer Date: its meeting No.14/82 dated 24.10.2013, 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. 541

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

Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00643/AM17/ RLA File :08/24/040/00184/AM17/ Lic.No/Date:0810138477 12.08.2016 Defer Date: 15.12.2016 542

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

LABORATORIES LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00681/AM17/ RLA File :03/94/040/00421/AM17/ Lic.No/Date:0310807134 16.08.2016 Defer Date: 15.12.2016 543

Case No.:25/13/82-ALC4/2016 Party Name:DIVIS

LABORATORIES LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00653/AM17/ RLA File :09/24/040/00254/AM17/ Lic.No/Date:0910064042 16.08.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/209/2016-PI(Norms) dated 24.10.2016, uploaded 544

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

CHEM-TECH LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00642/AM17/ RLA File :08/24/040/00181/AM17/ Lic.No/Date:0810138489 16.08.2016 Defer Date: 15.12.2016 Decision :Deferred. 545

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

CHEM-TECH LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00644/AM17/ RLA File :08/24/040/00191/AM17/ Lic.No/Date:0810138490 16.08.2016 Defer Date: 15.12.2016 Decision :Deferred. 546

Case No.:140/13/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:0510399463 Defer Date:

:01/82/050/00768/AM17/ :05/24/040/00181/AM17/ 16.08.2016 15.12.2016 547

Case No.:51/13/82-ALC4/2016 Party Name:BENZO CHEM

INDUSTRIES PRIVATE LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00679/AM17/ RLA File :03/94/040/00359/AM17/ Lic.No/Date:0310807160 17.08.2016 Defer Date: 15.12.2016 Decision :Deferred. 548

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

HEALTHCARE LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00639/AM17/ RLA File :08/24/040/00190/AM17/ Lic.No/Date:0810138500 17.08.2016 Defer Date: 15.12.2016 549

Case No.:33/13/82-ALC4/2016 Party Name:IND-SWIFT

LABORATORIES LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00661/AM17/ RLA File :22/24/040/00044/AM17/ Lic.No/Date:2210015545 17.08.2016 Defer Date: 15.12.2016 550

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

CHEMOFARBE INDUSTRIES LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00680/AM17/ RLA File :03/94/040/00160/AM17/ Lic.No/Date:0310807167 17.08.2016 Defer Date: 15.12.2016 Decision :Deferred. 551

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

INDUSTRIES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00668/AM17/ RLA File :52/24/040/00036/AM17/ Lic.No/Date:5210042006 19.08.2016 Defer Date: 15.12.2016 Decision :Deferred. 552

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

Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00647/AM17/ RLA File :05/23/040/00234/AM17/ Lic.No/Date:0510399492 19.08.2016 Defer Date: 15.12.2016 553 Case No.:142/13/82- ALC4/2016 Party Name:SUN PHARMACEUTICAL Meet No/Date:13/82- ALC4/2016 Status:Case Deferred

INDUSTRIES LTD., 16.11.2016 HQ File :01/82/050/00770/AM17/ RLA File :05/24/040/00226/AM17/ Lic.No/Date:0510399509 19.08.2016 Defer Date: 15.12.2016 554

Case No.:150/13/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00778/AM17/ RLA File :05/24/040/00201/AM17/ Lic.No/Date:0510399507 19.08.2016 Defer Date: 15.12.2016 555

Case No.:151/13/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00779/AM17/ RLA File :05/24/040/00227/AM17/ Lic.No/Date:0510399510 19.08.2016 Defer Date: 15.12.2016 556

Case No.:152/13/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00780/AM17/ RLA File :05/24/040/00200/AM17/ Lic.No/Date:0510399505 19.08.2016 Defer Date: 15.12.2016 557

Case No.:56/13/82-ALC4/2016 Party Name:IPCA

LABORATORIES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00684/AM17/ RLA File :03/94/040/00444/AM17/ Lic.No/Date:0310807298 22.08.2016 Defer Date: 15.12.2016 558

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

& PHARMACEUTICALS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00697/AM17/ RLA File :03/94/040/00339/AM17/ Lic.No/Date:0310807289 22.08.2016 Defer Date: 15.12.2016 559

Case No.:158/13/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00786/AM17/ RLA File :05/23/040/00242/AM17/ Lic.No/Date:0510399523 22.08.2016 Defer Date: 15.12.2016

560

Case No.:112/13/82-

ALC4/2016 Party Name:AIMS IMPEX PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00740/AM17/ RLA File :03/94/040/00436/AM17/ Lic.No/Date:0310807309 23.08.2016 Defer Date: 15.12.2016 561

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

& PHARMACEUTICALS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00696/AM17/ RLA File :03/94/040/00453/AM17/ Lic.No/Date:0310807316 23.08.2016 Defer Date: 15.12.2016 562

Case No.:156/13/82-

ALC4/2016 Party Name:MAHIMA LIFE SCIENCES PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00784/AM17/ RLA File :05/24/040/00214/AM17/ Lic.No/Date:0510399536 23.08.2016 Defer Date: 15.12.2016 563

Case No.:157/13/82-

ALC4/2016 Party Name:MAHIMA LIFE SCIENCES PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00785/AM17/ RLA File :05/24/040/00215/AM17/ Lic.No/Date:0510399537 23.08.2016 Defer Date: 15.12.2016 564

Case No.:141/13/82-

ALC4/2016 Party Name:RHYDBURG Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00769/AM17/ RLA File :05/24/040/00239/AM17/ Lic.No/Date:0510399535 23.08.2016 Defer Date: 15.12.2016 565

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

LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00703/AM17/ RLA File :03/94/040/00456/AM17/ Lic.No/Date:0310807339 24.08.2016 Defer Date: 15.12.2016 566

Case No.:55/13/82-ALC4/2016 Party Name:CORAL

LABORATORIES LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00683/AM17/ RLA File :03/94/040/00441/AM17/ Lic.No/Date:0310807355 24.08.2016 Defer Date: 15.12.2016

567

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

LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Approved HQ File :01/82/050/00641/AM17/ RLA File :09/24/040/00278/AM17/ Lic.No/Date:0910064066 24.08.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/211/2016-PI(Norms) dated 24.10.2016, uploaded 568

Case No.:60/13/82-ALC4/2016 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00688/AM17/ RLA File :03/95/040/00434/AM17/ Lic.No/Date:0310807413 26.08.2016 Defer Date: 15.12.2016 Decision :Deferred. 569

Case No.:21/13/82-ALC4/2016 Party Name:BALAJI AMINES

LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00649/AM17/ RLA File :31/83/040/00045/AM17/ Lic.No/Date:3110066311 29.08.2016 Defer Date: 15.12.2016 Decision :Deferred. 570

Case No.:22/13/82-ALC4/2016 Party Name:BALAJI AMINES

LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00650/AM17/ RLA File :31/83/040/00044/AM17/ Lic.No/Date:3110066310 29.08.2016 Defer Date: 15.12.2016 Decision :Deferred. 571

Case No.:23/13/82-ALC4/2016 Party Name:BALAJI AMINES

LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00651/AM17/ RLA File :31/83/040/00042/AM17/ Lic.No/Date:3110066309 29.08.2016 Defer Date: 15.12.2016 Decision :Deferred. 572

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

CHEMICALS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00722/AM17/ RLA File :08/24/040/00137/AM17/ Lic.No/Date:0810138556 29.08.2016 Defer Date: 15.12.2016 Decision :Deferred. 573 Case No.:160/13/82- ALC4/2016 Party Name:FRESENIUS Meet No/Date:13/82- ALC4/2016 Status:Case Deferred

16.11.2016 HQ File :01/82/050/00788/AM17/ RLA File :05/23/040/00252/AM17/ Lic.No/Date:0510399569 29.08.2016 Defer Date: 15.12.2016 574

Case No.:161/13/82-

ALC4/2016 Party Name:FRESENIUS Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00789/AM17/ RLA File :05/23/040/00251/AM17/ Lic.No/Date:0510399568 29.08.2016 Defer Date: 15.12.2016 575

Case No.:123/13/82-

ALC4/2016 Party Name:D. R. COATS INK & RESINS PVT. LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00751/AM17/ RLA File :03/94/040/00265/AM17/ Lic.No/Date:0310807443 30.08.2016 Defer Date: 15.12.2016 Decision :Deferred. 576

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

BIOTEC LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00709/AM17/ RLA File :05/24/040/00258/AM17/ Lic.No/Date:0510399580 30.08.2016 Defer Date: 15.12.2016 Decision : Deferred for want of comments from DBT. 577

Case No.:133/13/82-

ALC4/2016 DYE-CHEM PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00761/AM17/ RLA File :03/95/040/00239/AM17/ Lic.No/Date:0310807508 31.08.2016 Defer Date: 15.12.2016 Decision :Deferred. 578

Case No.:134/13/82-

ALC4/2016 DYE-CHEM PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00762/AM17/ RLA File :03/95/040/00249/AM17/ Lic.No/Date:0310807509 31.08.2016 Defer Date: 15.12.2016 Decision :Deferred. 579

Case No.:132/13/82-

ALC4/2016 Party Name:ZIM LABORATORIES LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00760/AM17/ RLA File :03/95/040/00448/AM17/ Lic.No/Date:0310807505 31.08.2016 Defer Date: 15.12.2016

580

Case No.:110/13/82-

ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00738/AM17/ RLA File :03/94/040/00415/AM17/ Lic.No/Date:0310807546 01.09.2016 Defer Date: 15.12.2016 Decision :Deferred. 581

Case No.:111/13/82-

ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00739/AM17/ RLA File :03/94/040/00473/AM17/ Lic.No/Date:0310807547 01.09.2016 Defer Date: 15.12.2016 Decision :Deferred. 582

Case No.:120/13/82-

ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00748/AM17/ RLA File :03/94/040/00390/AM17/ Lic.No/Date:0310807543 01.09.2016 Defer Date: 15.12.2016 Decision :Deferred. 583

Case No.:124/13/82-

ALC4/2016 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00752/AM17/ RLA File :03/94/040/00464/AM17/ Lic.No/Date:0310807534 01.09.2016 Defer Date: 15.12.2016 Decision :Deferred. 584

Case No.:121/13/82-

ALC4/2016 Party Name:GOPALDAS VISRAM & CO.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00749/AM17/ RLA File :03/94/040/00469/AM17/ Lic.No/Date:0310807553 01.09.2016 Defer Date: 15.12.2016 Decision :Deferred. 585

Case No.:163/13/82-

ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00791/AM17/ RLA File :09/24/040/00285/AM17/ Lic.No/Date:0910064084 01.09.2016 Defer Date: 15.12.2016 586

Case No.:164/13/82-

ALC4/2016 LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00792/AM17/ RLA File :09/24/040/00311/AM17/ Lic.No/Date:0910064091 01.09.2016 Defer Date: 15.12.2016

587

Case No.:168/13/82-

ALC4/2016 LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00796/AM17/ RLA File :09/24/040/00301/AM17/ Lic.No/Date:0910064085 01.09.2016 Defer Date: 15.12.2016 588

Case No.:170/13/82-

ALC4/2016 LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00798/AM17/ RLA File :09/24/040/00284/AM17/ Lic.No/Date:0910064083 01.09.2016 Defer Date: 15.12.2016 589

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

HEALTHCARE PRIVATE LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00723/AM17/ RLA File :08/24/040/00161/AM17/ Lic.No/Date:0810138597 02.09.2016 Defer Date: 15.12.2016 590

Case No.:143/13/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00771/AM17/ RLA File :08/24/040/00124/AM17/ Lic.No/Date:0810138603 02.09.2016 Defer Date: 15.12.2016 591

Case No.:146/13/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00774/AM17/ RLA File :22/24/040/00046/AM17/ Lic.No/Date:2210015557 02.09.2016 Defer Date: 15.12.2016 592

Case No.:147/13/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00775/AM17/ RLA File :22/24/040/00047/AM17/ Lic.No/Date:2210015556 02.09.2016 Defer Date: 15.12.2016 593

Case No.:122/13/82-

ALC4/2016 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00750/AM17/ RLA File :03/94/040/00374/AM17/ Lic.No/Date:0310807578 02.09.2016 Defer Date: 15.12.2016

Decision :Deferred. 594

Case No.:145/13/82-

ALC4/2016 Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00773/AM17/ RLA File :22/24/040/00049/AM17/ Lic.No/Date:2210015554 02.09.2016 Defer Date: 15.12.2016 595

Case No.:109/13/82-

ALC4/2016 Party Name:AURA PHARMACEUTICALS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00737/AM17/ RLA File :03/94/040/00484/AM17/ Lic.No/Date:0310807613 06.09.2016 Defer Date: 15.12.2016 596

Case No.:79/13/82-ALC4/2016 Party Name:BALAJI AMINES

LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00707/AM17/ RLA File :31/83/040/00070/AM17/ Lic.No/Date:3110066330 07.09.2016 Defer Date: 15.12.2016 Decision :Deferred. 597

Case No.:131/13/82-

ALC4/2016 DYE-CHEM PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00759/AM17/ RLA File :03/95/040/00248/AM17/ Lic.No/Date:0310807651 07.09.2016 Defer Date: 15.12.2016 Decision :Deferred. 598

Case No.:135/13/82-

ALC4/2016 DYE-CHEM PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00763/AM17/ RLA File :03/95/040/00247/AM17/ Lic.No/Date:0310807650 07.09.2016 Defer Date: 15.12.2016 Decision :Deferred. 599

Case No.:136/13/82-

ALC4/2016 DYE-CHEM PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00764/AM17/ RLA File :03/95/040/00311/AM17/ Lic.No/Date:0310807649 07.09.2016 Defer Date: 15.12.2016 Decision :Deferred. 600

Case No.:130/13/82-

ALC4/2016 Party Name:UNIMAX LABORATORIES PVT.LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred

HQ File :01/82/050/00758/AM17/ RLA File :03/95/040/00438/AM17/ Lic.No/Date:0310807648 07.09.2016 Defer Date: 15.12.2016 601

Case No.:138/13/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00766/AM17/ RLA File :03/95/040/00467/AM17/ Lic.No/Date:0310807656 07.09.2016 Defer Date: 15.12.2016 Decision :Deferred. 602

Case No.:167/13/82-

ALC4/2016 LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00795/AM17/ RLA File :09/24/040/00300/AM17/ Lic.No/Date:0910064112 08.09.2016 Defer Date: 15.12.2016 603

Case No.:169/13/82-

ALC4/2016 LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00797/AM17/ RLA File :09/24/040/00302/AM17/ Lic.No/Date:0910064113 08.09.2016 Defer Date: 15.12.2016 604

Case No.:108/13/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00736/AM17/ RLA File :03/94/040/00506/AM17/ Lic.No/Date:0310807686 08.09.2016 Defer Date: 15.12.2016 605

Case No.:137/13/82-

ALC4/2016 Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00765/AM17/ RLA File :03/95/040/00437/AM17/ Lic.No/Date:0310807709 08.09.2016 Defer Date: 15.12.2016 Decision :Deferred. 606

Case No.:159/13/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00787/AM17/ RLA File :05/24/040/00264/AM17/ Lic.No/Date:0510399649 08.09.2016 Defer Date: 15.12.2016 607 Case No.:98/13/82-ALC4/2016 Party Name:CADILA Meet No/Date:13/82- Status:Case

ALC4/2016 16.11.2016 Deferred HQ File :01/82/050/00726/AM17/ RLA File :08/24/040/00235/AM17/ Lic.No/Date:0810138637 09.09.2016 Defer Date: 15.12.2016 608

Case No.:162/13/82-

ALC4/2016 Party Name:HETERO DRUGS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00790/AM17/ RLA File :09/24/040/00309/AM17/ Lic.No/Date:0910064122 09.09.2016 Defer Date: 15.12.2016 609

Case No.:166/13/82-

ALC4/2016 LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00794/AM17/ RLA File :09/24/040/00314/AM17/ Lic.No/Date:0910064123 09.09.2016 Defer Date: 15.12.2016 610

Case No.:165/13/82-

ALC4/2016 Party Name:HONOUR LAB LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00793/AM17/ RLA File :09/24/040/00321/AM17/ Lic.No/Date:0910064126 09.09.2016 Defer Date: 15.12.2016 611

Case No.:106/13/82-

ALC4/2016 Party Name:GLENMARK Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00734/AM17/ RLA File :03/94/040/00538/AM17/ Lic.No/Date:0310807771 14.09.2016 Defer Date: 15.12.2016 612

Case No.:128/13/82-

ALC4/2016 Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00756/AM17/ RLA File :03/95/040/00162/AM17/ Lic.No/Date:0310807777 14.09.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.33/82 dated 21.03.2013, 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. 613

Case No.:148/13/82-

ALC4/2016 Party Name:THEON Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred

HQ File :01/82/050/00776/AM17/ RLA File :22/24/040/00055/AM17/ Lic.No/Date:2210015561 14.09.2016 Defer Date: 15.12.2016 614

Case No.:104/13/82-

ALC4/2016 Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00732/AM17/ RLA File :03/94/040/00468/AM17/ Lic.No/Date:0310807804 15.09.2016 Defer Date: 15.12.2016 Decision :Deferred. 615

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

SCIENCES PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00721/AM17/ RLA File :05/24/040/00217/AM17/ Lic.No/Date:0510399726 15.09.2016 Defer Date: 15.12.2016 616

Case No.:105/13/82-

ALC4/2016 Party Name:AARTI DRUGS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00733/AM17/ RLA File :03/94/040/00487/AM17/ Lic.No/Date:0310807836 16.09.2016 Defer Date: 15.12.2016 617

Case No.:102/13/82-

ALC4/2016 Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00730/AM17/ RLA File :03/94/040/00544/AM17/ Lic.No/Date:0310807851 16.09.2016 Defer Date: 15.12.2016 Decision :Deferred. 618

Case No.:107/13/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00735/AM17/ RLA File :03/94/040/00540/AM17/ Lic.No/Date:0310807829 16.09.2016 Defer Date: 15.12.2016 619

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

CHEM-TECH LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00674/AM17/ RLA File :08/24/040/00215/AM17/ Lic.No/Date:0810138683 16.09.2016 Defer Date: 15.12.2016 Decision :Deferred. 620 Case No.:153/13/82- Party Name:JODAS EXPOIM Meet No/Date:13/82- Status:Case

ALC4/2016 PVT.LTD., ALC4/2016 16.11.2016 Deferred HQ File :01/82/050/00781/AM17/ RLA File :05/23/040/00265/AM17/ Lic.No/Date:0510399737 16.09.2016 Defer Date: 15.12.2016 621

Case No.:155/13/82-

ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00783/AM17/ RLA File :05/23/040/00264/AM17/ Lic.No/Date:0510399736 16.09.2016 Defer Date: 15.12.2016 622

Case No.:129/13/82-

ALC4/2016 DYE-CHEM PVT. LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00757/AM17/ RLA File :03/95/040/00313/AM17/ Lic.No/Date:0310807812 16.09.2016 Defer Date: 15.12.2016 Decision :Deferred. 623

Case No.:42/13/82-ALC4/2016 Party Name:ALEMBIC

PHARMACEUTICALS LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00670/AM17/ RLA File :34/24/040/00174/AM17/ Lic.No/Date:3410042536 20.09.2016 Defer Date: 15.12.2016 624

Case No.:103/13/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00731/AM17/ RLA File :03/94/040/00516/AM17/ Lic.No/Date:0310807914 20.09.2016 Defer Date: 15.12.2016 625

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

PHARMA LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00671/AM17/ RLA File :09/24/040/00303/AM17/ Lic.No/Date:0910064168 21.09.2016 Defer Date: 15.12.2016 626

Case No.:101/13/82-

ALC4/2016 Party Name:GALAXY SURFACTANTS LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00729/AM17/ RLA File :03/94/040/00552/AM17/ Lic.No/Date:0310807954 21.09.2016 Defer Date: 15.12.2016 Decision :Deferred.

627

Case No.:119/13/82-

ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00747/AM17/ RLA File :07/24/040/00207/AM17/ Lic.No/Date:0710110442 21.09.2016 Defer Date: 15.12.2016 Decision :Deferred. 628

Case No.:149/13/82-

ALC4/2016 Party Name:THEON Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00777/AM17/ RLA File :22/24/040/00058/AM17/ Lic.No/Date:2210015566 21.09.2016 Defer Date: 15.12.2016 629

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

OPHTHALMICS PVT LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00673/AM17/ RLA File :08/24/040/00216/AM17/ Lic.No/Date:0810138715 22.09.2016 Defer Date: 15.12.2016 Decision : Deferred for want of comments from DBT. 630

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

HEALTHCARE LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00719/AM17/ RLA File :08/24/040/00242/AM17/ Lic.No/Date:0810138723 22.09.2016 Defer Date: 15.12.2016 631

Case No.:92/13/82-ALC4/2016 Party Name:CADILA

HEALTHCARE LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00720/AM17/ RLA File :08/24/040/00243/AM17/ Lic.No/Date:0810138725 22.09.2016 Defer Date: 15.12.2016 632

Case No.:100/13/82-

ALC4/2016 Party Name:K V AROCHEM PVT. LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00728/AM17/ RLA File :03/94/040/00525/AM17/ Lic.No/Date:0310807975 22.09.2016 Defer Date: 15.12.2016 Decision :Deferred. 633

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

SPECIALTY MATERIALS (INDIA) PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00710/AM17/ RLA File :52/24/040/00040/AM17/ Lic.No/Date:5210042029 22.09.2016 Defer Date: 15.12.2016

Decision :Deferred. 634

Case No.:97/13/82-ALC4/2016 Party Name:PI INDUSTRIES

LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status: Approved HQ File :01/82/050/00725/AM17/ RLA File :13/24/040/00026/AM17/ Lic.No/Date:1310048388 23.09.2016 Defer Date: its meeting No.13/82 dated 03.10.2013, 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. 635

Case No.:127/13/82-

ALC4/2016 Party Name:SUPRIYA LIFESCIENCE LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00755/AM17/ RLA File :03/95/040/00504/AM17/ Lic.No/Date:0310808030 23.09.2016 Defer Date: 15.12.2016 636

Case No.:113/13/82-

ALC4/2016 LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00741/AM17/ RLA File :09/24/040/00342/AM17/ Lic.No/Date:0910064191 27.09.2016 Defer Date: 15.12.2016 637

Case No.:114/13/82-

ALC4/2016 LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00742/AM17/ RLA File :09/24/040/00341/AM17/ Lic.No/Date:0910064192 27.09.2016 Defer Date: 15.12.2016 638

Case No.:139/13/82-

ALC4/2016 Party Name:VISWAAT CHEMICALS LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00767/AM17/ RLA File :03/95/040/00302/AM17/ Lic.No/Date:0310808110 27.09.2016 Defer Date: 15.12.2016 Decision :Deferred. 639

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

Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00727/AM17/ RLA File :08/24/040/00214/AM17/ Lic.No/Date:0810138766 29.09.2016 Defer Date: 15.12.2016 Decision :Deferred. 640 Case No.:90/13/82-ALC4/2016 Party Name:AMI ORGANICS Meet No/Date:13/82- Status:Case

PVT LTD. ALC4/2016 16.11.2016 Deferred HQ File :01/82/050/00718/AM17/ RLA File :52/24/040/00042/AM17/ Lic.No/Date:5210042032 30.09.2016 Defer Date: 15.12.2016 Decision :Deferred. 641

Case No.:125/13/82-

ALC4/2016 Party Name:SURVIVAL Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00753/AM17/ RLA File :03/95/040/00490/AM17/ Lic.No/Date:0310808208 30.09.2016 Defer Date: 15.12.2016 Decision :Deferred. 642

Case No.:126/13/82-

ALC4/2016 Party Name:SURVIVAL Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00754/AM17/ RLA File :03/95/040/00410/AM17/ Lic.No/Date:0310808209 30.09.2016 Defer Date: 15.12.2016 Decision :Deferred. 643

Case No.:96/13/82-ALC4/2016 Party Name:CLEAN SCIENCE

AND TECHNOLOGY PVT.LTD. Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00724/AM17/ RLA File :31/83/040/00090/AM17/ Lic.No/Date:3110066356 07.10.2016 Defer Date: 15.12.2016 Decision :Deferred. 644

Case No.:86/13/82-ALC4/2016 Party Name:SUN

PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00714/AM17/ RLA File :05/24/040/00320/AM17/ Lic.No/Date:0510400111 17.10.2016 Defer Date: 15.12.2016 645

Case No.:88/13/82-ALC4/2016 Party Name:ALEMBIC

PHARMACEUTICALS LTD Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00716/AM17/ RLA File :34/24/040/00194/AM17/ Lic.No/Date:3410042597 19.10.2016 Defer Date: 15.12.2016 646

Case No.:87/13/82-

ALC4/2016 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:13/82- ALC4/2016 16.11.2016 Status:Case Deferred HQ File :01/82/050/00715/AM17/ RLA File :09/24/040/00238/AM17/ Lic.No/Date:0910064273 19.10.2016 Defer Date: 15.12.2016

Cases considered out of agenda

Case No. B- 01

M.No.13/AM-17 Date 16.11.2016 M/s Pregna International Ltd. F.No.01/82/50/1142/AM16 RLA File No.03/95/040/00364/AM16 Adv.Auth.No.03107982874 dated 20.08.2015 Decision: The Committee considered this case for correction/amendment in the description of import item from “Granules (Moulding Grade)” to “HDPE Granules (Moulding Grade)” as per agenda. The Committee decided to amend the description of import item to read as “HDPE Granules (Moulding Grade)”. RA concerned may take further necessary action as per the decision of NC.

Case No. B- 02

M.No.13/AM-17 Date 16.11.2016 M/s. Alembic Pharmaceuticals Ltd. F.No.01/82/50/0001/AM17 Adv.Auth.No.3410041911 dated 19.2.2016 Decision: The Committee considered this case for revision of norms as per agenda. The Committee decided to ratify norms as per the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/497/2015-PI(Norms) dated 23.12.2015, 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.

---

l3 ^.) F. No.3501 1/81212015-Pl (Norms) Government of lndia Ministry of Chemical & Fertilizers Department of Pharmaceuticals Udyog Bhawan, New Delhi, Dated: June,2016 Office Memorandum

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

14 Case of M/s Lake Chemicals (P) Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182150143214M- 15/DES-3/1628 dated the 1612116vide which application from M/s Lake Chemicals (P) Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Lorazepam. 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:- This issues with the approval of competent authority. (Rajkumar) Under Secretary to the Government of lndia PH:23071'162 Directorate General of Foreign Trade, Department of Commerce, (Shri M.V. Singh, FTDO), Udyog Bhawan, New Delhi S.No. lmport item Norms Recommended for 1kq Export 1 2-amino-2, 5-dichloro-benzophenone 1.60kq

,5 o$ F. No.350 l 1 1441 12015-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 M/s Thinq Pharma CRO Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182/501217lAM-|61DES-3/369 dated the 03107115 vide which application from M/s. Thinq Pharma CRO Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Ractopamine Hcl BP/USP/EP. This department has examined the matter and the following norrns are furnished under para4.7 of Hand Book of Procedures (Vol.l) 2009-14:- (Raj Kumar) Under Secretary to the Government of India Phone:23071162 S. No. Import ltem Qty. Recommended kg/kg. l Amino Acetonitrile Hcl l.l9

⊂タキ |( F. No.3501 1156612014-Pl (Norms) Government of lndia Ministry of Chemicals & Fertilizers DePartment of Pharmaceuticals Shastri Bhawan,New Delhi, Dated the SePtember 5, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures about request

of M/s Alembic Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/050/00735/AM- 15/DES-3/744 dated lhe 21107t2014 and additional information received on 12th May 2016, about an application from M/s. Alembic Pharma Ltd. was sent to this Department for fixation of norm!"unJ", p.rr, 4.7 for the export of rrbesart6p + Hydrochlorothiazide tablets. This departmeni has examined the matter and the following norms are furnished for the 3 strengths of lrbesartan + Hydrochlorothiazide tablets: - 2. This issues with the approval of competent authority' (Ral Kumar) Under Secretary tO the(351:‖」 re,::;1腎:3 Directorate Genera1 0f Foreign Trade, 爾∬騨肌 i rtan + HYdrochloride tablets: Each tablet conlqln Name of Export Product 300 mg lrbesartan + 25 mg Hydrochlorothi azide 300 rng lrbesartan+ 12.5 mg Hydrochlo「othia zide 150 rng lrbesartan+ 12.5 mg Hydrochloro thiazide Description of the raw material 153.00 gm lrbesartan + Hydroch!Or Othiazide tab:etS 211.80 gm 211.80 gm Lactose MonohYdrate (Granulac 200) 18.00 gm 12.75 gm 12.75 gm

一 協 イ 一 券 一 一 一 F ,(1:"'｀ Govemment of lndia Ministry of Chemicals and Fertilizers Deparlment of Chenricals and petrochemicals

Subject: Advance Authorization application from M/s. P.l lndustries Ltd. Ltd. for the import of

raw material against the export of Ethyl 4-Chloro-2 Ftuoro- 5[ ((isopropyl) (methyl)] aminol sulfonyllAmino) carbonylJ phenylcarbamate (pCM). (Advance Authorization No. 131ao47sr| dated 12.og.zo14) DGFT File No 9lt12ti1t}IglB/AM-IS dared 22.11.2A1s Mis. P.l lndustries Ltd. have submitted present application for the import of raw material againsl the export of Ethyl 4-Chloro-2 Fluoro- 5[ {(isopropyt) (methyt)J amino] sulfonyllAmino) carbonytJ phenylcarbamate (pCM). The application have been examined and the Department recommends the following norms for the present Advance Authorization application. (A.K.ACARWAL) Addi.lndustrial Adviser Tel.No.011‐23381430 mmJKumaLD■ DGF「.OES硼)0/o DG日,Udvoo BhawaRNew Delhi― 性 Deptt.of C&P‐ CU.〇.No.150226ノ2010‐CH‐lldated 10.08.2016

1. ltem of Export Qtv Item of lmport Qty Ethyl 4-Chloro-2 Fluoro- Et {(isopropyl} (methyl) aminol sulfonyliAmino) carbonyll phenylcarbamate (PCM). l kg. 1.2-ChloFon4‐ Fluoro Toluene 0.933K9
2. Methyl lso PropylAmine 0.328 Kg. 3.Noblyst(R)P80861%(Pt/C Catalyst(+1%PT+2%VノC:64% H20))or CatalySt(+0.8%PT― 0.3%MoCP〕 0.005 Kg. 4.Methanol 1.797 Ko.
3. Toluene 0_595 Kg. 6.Ethvi Chlo「oformate 0.389 Kc. 7.Sulfuryi Chloride 0.679 Kg.
4. n-Hexane 1.097 Ko.

ハ 13 57 IHQ Filc lRLA Filc :01ノ82/1150/01055/AM14/ 1:03/95/040/00725/AM 14/ Mcct No/Datc:3/82‐ ‐ALC4/2014 108052014 ILic No/Date:0310761482 111 122013 Povidone lodine 10° /。Solution {Avallab!e lodine NLT l%w/v) L.O2 kgper kg contained in the RA concerned may take further necessary action as per above decision of NC. Export product ０ い ｏ ｔ ｖ Si No. lmport items Quantity Allowed l kg Povidone lodine

´ 凛オデル Sublecti Goveramont oflndia Ministry of Chemicals and Fertllzers Department oF Chemicals arld PetrOchemicats Advance Auhorizatlon applicatioソfrom Ws.Tlde industries For the import of raw mate薔31 againstthe export of Rose Oxlde etc The applicaiionrhas been examined and the Deparlment recommonds the following norms for the present Advance Authorization application. 。 　 　 　 　 い ヽ ヽ 0/ This iSsu“ With the approval of competent 3utho‖ ● . ぃに勝 に ● ハ

「 lTT饉 題I■‐ l二1_1.1_三二二==ニニ ===ニ ユ ー 13 7g 「 一 多 一 ″ S′ ,21Cr・ , ″ 一 多 F. No.3501 1 169212015-Pl (Norms) Governnrent of lndia Dated: 26 F ebruarY, 2016 Office Memorandum

Subject: - Fixation of nornrs urrder para 4.7 of Hand Book of Procedures (Vol'l) 2009-

14 Case of M/s Honour Lab Ltd. The undersignecl is directecl to refer to DGFT U.O.No. O1lB2l50l953lAM- 16/DES-3/1021 dated tlre 28/',10/15 vicle which application from M/s Honour Lab Lttj' was sent to this Departnrent for fixation of norms under para' 4'7 for the export of 4- chloro-2-trifluoro acetyl aniline hycJrochloride hydrate. Tlris departnrent I'ras examined the mattercno tt'.lu following norms are furnished under para 4'7 of Hancl Book of Procedures (Vol.l) 2009-14'.- lmport ltert U『 ~1 hloroan‖ ine 9≦X12事9___ 2. This issues with tlre approval of competent authority Under Secretary to the Governmerrt of lndia PH'- 23071162 ,Directorate General of Foreign Trade' tsritiM V Singh, FTDO), Udvog Bhawan, New Delhi 一――一―p≦盪1ヒ9__ ____1:100ドg ■Butyl Chlttф Lithium metal 01681く 4 5 f9「 1卜9_三卜P9rt 0 626kg chloride tnfluoro acetate 245К 9_ゾ

319 で1:こ雨」ib恩′ib/8'LALむ4'2012‐ IP:A'｀lmeibЁ ЁIAK NIttRIiE IMeet No/Date:28/82‐ IALC4/2012 ‐LIMITED : ' 「面デЮ ""η ttrDに 1 1 19聖 "_… … 臨 νⅧ lo.ol.2013 :01/82/050/01005/AM13/ :34/24/040/00064/AM13/ firm, whichevg{qless: RIFi:書デi:ittiiFi'3高石 Iξ弓正 i喪式市葛麗可扇覇 F有石 「て戻粟 T'戻 F「「F¬更Orms Comrrlittee. i:itt i五6 1lLA1 6rearlier decision taken in meeting no.44/82 dated 31.L2012,it was to ratify norms under Para 4.7 of HBP Vl as per details g市 en be10W Or aS applied by Approved

ハ τ |:|||:|::|:::|:||:|:lli:ii】 iZi71i:,1:~~~― ― ¨ ― ― ― ‐ liilliI:ilillli:illi:; 「 | HQ File :01/82/050/00570/AM14/ Decision :ln the light of written comments received from Department of Pharmaceuticals vide ir OM No. 3501 1169212013-PI(Norms) dated 01.04.2014, it was decided to ratifo norms under pata 4.7 of HBP v I as per details given below or as applied by the firm, whichever is less: RA may take appropriate action as per the decision of Norms Committee. CHEM ITED RLA File :09/24/040/00136/AM14/ Export product Exp. Qtv. S:.No. lmport items Qty.al10wed Kg/kg EPINASTINE HCL Kg 1. 6-Aminomethyl-6, I l- Dihydro-5H-Dibenz {b,e}Azepine(E) 2Butendioate 2.00 2. ヽ/1cthylcnc Dichloridc 3.37 3. Toluene 2.50 4. Iso Propyl Alcohol 2.435 94

'LIMITED, IRLA File :04/24/040ノ00236/AM12/ 1多 一 |クひ ILic NoノDate:0410131109 130112011 Decision : Committee considered case as per agenda and in light of written comments fonruarded by Deptt of C&PCvidetheirU.O.No. 140101712010-Ch.ll dated05.06.2012 decidedtoratify normsunderpara4.T HBP as per details below or as applied by firm whichever is lower:- 1 124 kg 0 416 kg RA concerned may take further necessary action as per above decision of NC Meet NoノDate:10/82‐ 4-(2-Aminoethyl)-2- methoxyphenol. Vanillin Sodium Cyanide :01/82ノ050/01183′AM12/ 2 叩

;/f- ., \t f No.eSO 11t75gt2015-Pl (Norms) Government of lndia O"Prri,"nt of Pharmaceuticals Udyog Bhawan, New Delhi' Dated: APril' 2016 Office Memorandum subiect: _ Fixation of norms under para 4.7 of Hand Book of Procedures (Vol'l) 2009-14 Case of Mts Vision Drugs Pvt' Ltd' The undσ」 gnedも´ J"摯91.■.γ‰猟黒∬In‖ぶ‰/P確省蹴::1社 , u,,, J1?, ;rs ?:i: ::,1 " i .i [,T ! il t.ii * tsllmi;:,y t ) i: : i'. 3']';" [. [J'I::t:ffi tix.:',Hiillilii;t,1':-,:sffi ffi i']:;rji;l&L!??J,?""J*J l:;[t"::l]J:,1[:,',wlH[:i:lilht'*1'-"]T[*ni,li:il?,1[e{o'wns ffi: X,";?JH:i['i"ily]'' l': iT :i fiTil"'i "1-o?''o'1 0 ""' (Vo r r ) 2o0e - 1 4 - -..---; Nornns-Rtcoffiended for lkg E 2 Methanol Chloroform This issues with the approval of competent authority' PH'- 23071162 Directorate General of Foreign Trade' Department of Commerce' rSfrri frl.V- Singh, FTDO)' iilil Bhawan, New Delhi S----oOum Cyanide Pa-raformaldeh

ハ タ 鮮~翻 寧~町 源蔦 :y~~際需湾駕雷勇410033044呼 agenda and in H8ht of written comments recdved from Department of Chemicals and Petrochemicals vide their U.O No. 1401018912004/Ch.lI dated .6.2007 and in consultation with representative of Department of Pharmaceuticals present in decided to ratifu norrns under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- RA may take appropriate action as per the decision of Norms Committee. Alumunium Chloride 2,4,6 Trimethyl Benzoyl Chloride

111‐ ■■ア ⌒ ヘ.´ヽ 上Je品of 悸 現 織逸 V需蕊薫 lrT「―‐ ―一 IC ACID o瓢濡ヨTAこ花 「

PHTHAttσ
,Of C&Pe U:0¬ 雨ご14010′ 24/2013‐CHJl daわd
iQ′10.2015
鼈ル
0:01o
ol■ic~燕罰百~~‐~
0,14σ KG
PENTAERYTHRi〒ろ正T
0.490 KG
Dф翼‖器
驚
櫂[継
謝織
i∞に
## subject: Advance Authoriza*on apprication from M/s. Mi*o rnk
marerrar asainst r," irp.,Ioi pbrvesririitnirii!?[,i,y;,1fi]lll,,[IJ*i,"*
(Advance Aurhorization No. 03107929gg dated 16.1.2015)
Ref: u'o' No' 01t82to5at251/AM16/DES-l,l4s3 dated 07,07.20.r5
. M/s Micro lnks pvt. Ltd Ltd. havo subrnittcrt nraca^r ^^^
materiai itain.iir,i'iip,rt or poLie'srintffi$iifi.,-o"Jlffg$fi;lf,T.:Lthe imporr or raw
norms rlifr:Hx::ilinhEffil"?;il:1.:p;il*ll]*"rarrmenr recommends the roilowins
This issueS with the approval of cOInpetent authorlty.
、_´ .ノ

“
（

|ろ
ZИ ン
F.No.3501 1 /1 93/201 6-Pl (Norms)
Government of lndia
Dated: 30 S"{, 
,2016
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14
Case of M/s Cadila Pharmaceuticals Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01l82l50l191lAM-17/DES-
3/293 dated lhe 111712016 vide which application from M/s Cadila Pharmaceuticals Ltd.
was sent to this Department for fixation of norms under paz:4.7 for the export of
Azithromycin 250mg Capsules. 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
lmport item
Norms Recommended
1
Azithromycin Dihydrate
267 256mg/250mg
Capsules
2
Under Secretary to the Government oflndia
PH■23071162
Depattment of Commerce,
(shn M v singh,FTDO),
Udyog Bhawan,New Delhi

⌒
身
ICase No.:3/19/82‐ ALC4/2013 P征けNamciSIRMAX0
1                     CHEMICALS PVT LTD
IHQ Filc              RLA File
:01/82/050ノ00948/AM14/       :03/95/040/00625/AM14/
IMeet No/Date:6/82‐     Status:
IALC4/2014         ‐Approved
29082014
ecision : Committee considered the case as per agenda and in the light of earlier decision tal
meeting no.3/82 dated 08.05.2014, it was decided to ratifi/ norms under Para4.7 of HBP vl
r details given below or as applied by the firm, whichever is less:
Export product
ExpOrt
Qtv.
SI.No.
lmport items
Quanuty Allowed
Povidone lodineTopical Solution
USP 10%
(Available lodine bILT l%wん)
Povidone Iodine
L.02 kg per kg
content in the
export
concerned may take further necessary action as per above decision of NC. 」

te
ZJb6
F. No.3501 1 12512016-Pl (Norms)
Government of lndia
New Delhi,
Office Memorandum
Shastri Bhawan,
the September 8, 2016
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case
of M/s BDR Pharmaceuticals lnternational P. Ltd.
The undersigned is directed to refer to DGFT U.O. Nos. 011821050/01834/AM-16/DES-
3102 dated the 04.04.2016 vide which application from M/s BDR Pharmaceuticals
lnternational P. Ltd. was sent to this Department for fixation of norms under para:4.7 for the
export of Alpha Glycerylphosphorylcholine + Piracetam Tablets 250 mg + 800 mg. 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: -
2
This issues with the approval of competent authority
Phone: -23071162
Email : uspi3-pharma@nic. in
S No.
Export ltem
Quantity
●
０
Ｓ
Ｎ
Import ltem
Quantity
allowed
for 1000
tablets
Alpha
Glycerylphosphorylcholine +
Piracetam Tablets (each
tablet containing 250 mg Alpha
Glycerylphosphorylcholine and
800 mg Piracetam)
1 000 tablets
Alpha
Glycerylphosph
orylcholine
255 gm
2.
Piracetam BP
816 gm

1務
影}
F. No.3501 1/2412016-Pl (Norms)
Government of lndia
Shastri Bhawan,
New Delhi, the September 8, 2016
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case
of M/s BDR Pharmaceuticals lnternational P. Ltd.
The undersigned is directed to refer to DGFT U.O. Nos. 01/82i050/01835/AM-16/DES-
3/01 dated the 04.04.2016 vide which application from M/s BDR Pharmaceuticals
lnternational P. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the
export of Lenalidomide Capsules 25 mg in packs of 21 capsules. 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: -
Export ltem
Quantity
lmport ltem
Quantity allowed
for 100 packs of
21 capsules each
Lenalidomide Capsules 25 mg
in packs of 21 capsules (each
capsule contain 250 mg
Lenalidomide)
100 packs Of 21
capsules each
Lenalidomide
53.55 gm
2
This issues with the approval of competent authority
(RJi Kumar)
Phone: -23071 '162
Email: usPi3-Pharma@nic.in
Depanment Of COmmerCe,
(Shn M V Singh,FTDO),
udyOg Bhawan,New Delhi

β
一
2-'13
F. No.3501 1/2612016-Pl (Norms)
Government of lndia
Shastri Bhawan,
New Delhi, the September 8, 2016
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case
of M/s BDR Pharmaceuticals lnternational P. Ltd.
The undersigned is directed to refer to DGFT U.O. Nos. 01/82/050/01837/AM-16/DES-
3/07 dated the 04.04.2016 vide which application from Mis BDR Pharmaceuticals
lnternational P. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the
export of Abiraterone Acetate Tablets 250 mg in packs of 120 tablets. 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: -
Export ltem
Quantity
lmport ltem
Quantity allowed
for 100 packs of
120 tablets each
Abiraterone Acetate Tablets
250 mg in packs of 120 tablets
(each tablet contains 250 mg
Abiraterone)
100  packs  of
1 20 tablets each
Abiraterone
Acetate
3060 gm
. 
This issues with the approval of competent authority
(Raj Kumar)
Phone: -23071 162
Email: uspi3-pharma@nic.in
DireCtorate General of Foreign Trade,
Depanment Of Commerce,
(Sh‖ M V Singh,FTDO),
Udyog Bhawan,New Delhi

エ
2η %
F. No.3501 112512016-Pl (Norms)
Government of lndia
Shastri Bhawan,
New Delhi, the September B, 2016
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-'t4 Case
of M/s BDR Pharmaceuticals lnternational P. Ltd.
The undersigned is directed to refer to DGFT U.O. Nos. 01/821050/01839/AM-16/DES-
3/06 dated the 04.04.2016 vide which application from M/s BDR Pharmaceuticals
lnternational P. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the
export of Alpha Glycerylphosphoryl Choline lnjection 1000 mg. 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: -
Export ltem
Quantity
lmport ltem
Quan'ty a::owed
for 100 inieCtiOns
Alpha 
Glycerylphosphoryl
Choline lnjection 1000 mg (each
injection contain 250 mg per ml
Alpha Glycerylphosphoryl Choline
in 4 ml vials )
100
lnjections
L―Alpha
GlycerophosphOryl
Choline
110 gm
This issues with the approval of competent authority
(Raj KumaO
Phone: -23071 162
Email : uspi3-pharma@nic.in

F.No.35011′27ノ2016-PI―Norrns
Government oflndia
W:星朧黒讐弔階捕£
:11雷ξ
Shastri Bhawan,
New Delhi, the SePtember 9, 2016
Office Memorandum
## subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol'l) 2009-14 case
of M/s Titan Labs (P) Ltd'
TheundersignedisdirectedtorefertoDGFTU.o.No.ol/82/050/01850/AM-16/DES-
3t22 daredthe 0a.02. 2o16vide whicti "ppri."tion 
from.M/s Titan Labs (P) Ltd' was sent to this
Department for fixation of norms uni"i p.* 4r ror-the export of orlistat Pellets 50% w/w'
This department has examined the ,rti", and the foilowing norms are furnished under para
q.i ot HanO Book of Procedures (Vol'l) 2OO9-14"-
2) This issues with the approval of competent authority'
Phone: -23071162
Email: usPi3-Pharma@nic'in
Directorate(3enera1 0f Foreign Trade,
Depanment of COmmerCe,
器y獣酬l留甜hm“ 1
Orlistat Pellets
Sartac lComPound of Maize
Starch and Lactose
PolffiiylFYrolidone K-30
|:`争
稼
lmport!tem

F‖ e No.E… 35011′ 31′2016‐ Pi―Norrlls
13
―23Ч
F. No.3501 1 131 12016-Pl (Norms)
Government of lndia
Janpath Bhawan, New Delhi,
Dated: November 03, 2016
Office Memorandum
Sub. - Fixation of norms under para 4.7- Application of M/s BDR Pharmaceuticals lnternational Pvt. Ltd.
The undersigned is directed to referto DGFT U.O. No. 011821050101821/AM-16/DES-3/24 dated
O5tO4t2O16 and subsequent letter from M/s BDR Pharmaceuticals lnternational Pvt. Ltd for fixation of
norms against export of Ademetionine for lnjection 400 mg (Lyophilized) (Pack of 5 vials). This
department has examined the matter and following norms are recommended against this application.
Product to be Exported
Raw materials to be lmported
S,No
Description
Qυanffry
Descriρ lわρ
Qυ ar71″ y′br f ρack of5
ソbls
Ademetionine for
lnjection 400 mg
(Lyophilized) (each vial
contains Ademetionine 1,
4-butanedisulfonate)
l Pack of
5 vials
Ademetionine 1, 4-
butanedisulfonate
4.860 gm
2. 
This issues with the approval of Director (Pharma lndustry).
(Barnali Khastgir)
Phone: 23323292
Email. barn.khast@nic.in
(Shri M V Singh, FTDO),Udyog Bhawan, New Delhi.
Signature
alid
LI
:57:461S丁

File No,35011′32′2016‐ Pl‐ Norrlls
F. No.3501 1 13212016-Pl (Norms)
Government of lndia
Shastri
Dated:
Office Memorandum
鏡
Bhawan,New Delhi,
09h November 2016
Sub: - Fixation of norms under para 4.7- Application of M/s BDR Pharmaceuticals
lnternational Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O No. 011821050101825/AM-
16/DES-3/18 dated 0410412016 and subsequent letter from M/s BDR Pharmaceuticals
lnternational Pvt. Ltd for fixation of norms against export of Colistimethate Sodium for
lnjection BP 2 Million lnternational Units per vial (192.52 mg/vial). This department
has examined the matter and following norms are recommended against this
application.
Product to be Exported
Raw materials to be lmponed
S.Ⅳo
Description
Quantity
Description
Quantity for 100
vials
Colistimethate Sodium
for lniectiOn
(COntaining 2 MIU per
vial)
1 00 vials
Colistimethate
Sodium for
lnjection
17.6gm
つ
乙
This issues with the approval of Director (Pharma lndustry).
(Barnali Khastgir)
Phone: 23323292
Directorate General of Foreign ttrade】
(shn M v singh,FTDO),
udyog Bhawan,New Delhi
Signature
alid
|
Di91ta‖ y signed
KHASttα R
:38:21 1ST

β
一
“
iCase No.:4/20/82‐ ALC4/2013
1器島児
50Ю0990ハMW
ParりName:MICRO INKS
卜つ。
RLA
File
|:03/95/040/00556/AM14/
IMcet No/Date:20/82‐
IALC4/2013
116.01.2014
|
|
1
|
♭
51
1
|
|
|
|
Lic.No/Date:0310755766 
‐Defer Date:
28.102013
Decision : In the light of earlier decision taken inmeeting no. 33182 dated 21.03.2013, it
was decided to ratify norrns under Para 4.7 of HBP v1 as per details given below or as
applied by the firm, whichever is less:
Export product
恥
Ｑ
ｔ
ｖ
．
SI.No.
lmport items
Qtv
allowed
Adhesion 
Promoter
containing 62 + 1o/o Tetra
lsopropyl Titanate and 27 +
'1% Butanol
l MT
Butanol
0.2786 MT
2.
Tetra lsopropyl Titanate
0 6302 MT
3.
lsopropanol
0.1100 MT
may take appropriate action as per the decision of Norms Committee.

,rlsp \lazlro/*utr
F. No.3501 1 178312015-Pl (Norms)
Government of lndia
|ス
3o6
ヘ
Office Memorandum
Sutted,.日文a“n d norms undtt para 47研
Hand Book d PЮ
ッ
weS Ⅳd⇒2009-44
:AIliicatЪ
n l・Om M/s Encube Ethicals Pvt.Ltd.     
ゾ/
The undersigned is directed to refer to DGFT U.O. No. 01t\2tOSOlO1378/AM-16/DES-
31502 dated 1210112016 vide which an application from M/s Encube Ethicals pvt. Ltd was sent
to this Department for fixation of norms for the export of 31 type of packs of ointments/creams.
2) The matter has been examined and all these 31 export products have been categorized in
17 groups of ointments under different brands/generic formulations. The norms for each of the
categories for different pack sizes have been worked out based upon DML, Batch Formula and
SION published for this type of formulations. The quantities of different inputs for 100 tubes of
different pack sizes of specific composition of formulations as given below may be considered
as input output norms for the export products covered under this application.
Shasttt Bhawan,New Delhi,
Dated the August 22,2016
S.N
O
Name of
Export
Product
S.N
O
lnputs recommended
100 tubes
of14 gm
100 tubes of
42 gm
100 tubes
of28 gm
1
Miconazol
e20
Creams in
different
pack sizes
Benzoic Acid
0.28 gm
0.84 gm
0.56 gm
2.
Pegoxyl 7-stearate
280 gm
820 gm
560 gm
3.
Mineral O‖
42 om
126 gm
84 gm
4.
Oleoyl Polyoxylg lycerides
42 gm
126 gm
84 gm
5.
Butylated hvd roxva nisole
0.0728 gm
0.2184 gm
0.1456 qm
6.
Miconazole
28.56 gm
85.68 gm
57.12 gm
7.
Empty Laminated Printed
tubes of corresponding
sizes
As per Packing Policy
S. N
0
Name of
Export
Product
Ｎ
Ｓ
　
ｏ
lnputs recommended
100 tubes of 45
gm with 1
applicator
100 tubes of45
gm with 7
applicators
2
Miconazole
つ0ノ ρ
.・^^_^
4/0ヽ′!じdH:わ
Benzoic Acid
0.900 gm
0.900 gm
〔
∠
Fesoxyi 7-siearaie
900 gm
900 gm
3.
Mineral O‖
135 gm
135 gm
4.
Oleoyl Polyoxylg lycerides
135 gm
135 gm
5.
Butvlated hvd roxvan isole
0.234 gm
0.234 gm
6.
Miconazole
91.80 gm
91.80 gm
7.
tubes of corresponding sizes
As per Packing Policy
8.
1 or 7 applicators as per
product specification
100 packs of
one applicator
each
100 packs of
Seven applicator
each
―

-2‐
ヘ
Name of
Export
Product
S,No
lnputs recommended
100 tubes of
14 gm
100 tubes of 28
gm
3
Clotrimazole
1% creams
Cetostearyl Alcohol
140 om
280 gm
2.
Octyldodecanol
189 gm
378 gm
3.
Cetyl Esters
33 gm
66 gm
4.
Sorbitan Monostearate
28 gm
56 gm
5.
Polysorbate 60
21 gm
42 gm
6.
Clotrimazole
14.28 gm
28.56 gm
7.
BenzylAlcohol
14 gm
28 om
8.
Sodium 
Phosphate
Monobasic
2.24 gm
4.4 gm
9.
As per Packing Policy
S.No
Name 
of
Export
Product
S.No
lnputs recommended
100 tubes
of45 gm
with l
applicator
100 tubes of
45 gm with 7
applicators
4
Clotrimazole
1% creams
Plastic (LDPE) Applicators (1s
or 7s packs)
(100 pack
of1
applicator
each)
(100 pack of 7
applicators
each)
2.
Cetostearyl Alcohol
450 gm
450 gm
3.
Octyldodecanol
607.50 gm
607.50 gm
4.
Cetyl Esters
135,00 om
135.00 gm
5.
Sorbitan Monostearate
90.00 gm
90.00 gm
6.
Polysorbate 60
67.50 gm
67.50 gm
7.
Clotrimazole
45.00 gm
45.00 gm
8
Benzyl Alcohol
45.00 om
45.00 gm
9
Sodium Phosphate Monobasic
7.20 gm
7.200m
10.
As per Packing Policy
S.No
Name 
of
F:rnrrrf
Product
S.No
lnputs recommended
100 tubes of
:49『ロ
100 tubes
of28 0m
5.
Triple
Antibiotic
Ointment
White Petrolatum
Quantity not indicated in
the Batch formula
2.
Polymyxin B Sulfate (non-sterile)
7.14 MU
14.28 MU
3.
Bacitracin Zinc
7.22 gm
14.14 gm
4.
Neomycin Sulfate
4.998
9.996 gm
5.
tubes of correspondinq sizes
As per Packing Policy
S.No

ヘ
‐
3‐
lnputs recommended
100 tubes of 14 gm
Triple 
MS
Antibiotic
Ointment
White Petrolatum
Quantity not inOiCateO
in the Batch formula
Polymyxin @
Bacitracin Zinc
rueomycinS@
Empty Laminafed Pttnted
As per Pa
S.No
Name 
of
Export Product
S.No
rnputs recommended
100 tubes
of28 gm
100 tubes
of14 gm
17
Triple AntibiOtic
Ointment
1/V/PRAM
vvn:te retrOlatum
277.6032
gm
138.8016
gm
2.
Pramoxine HCL
28.56 gm
14.28 gm
3.
Bacitracin Zinc
18.05 gm
9.025 gm
4.
∬
14.28 MU
7.14 MU
5.
Neomycin Sulfate lmicronrzeO)
571.2 grn
285.60m
6.
Empty Laminated printed
As per Packing policy
S.No
Name of
Export
Product
S.No
inputs
reconlmended
100 tubes
of56 gm
100 tubes
of14 gm
100丁ubes
of28 gm
8
丁riple
AntibiOtic
Ointment EF
Cocoa Butter Ultra
Natural
2.5 gm
63 gm
126 gm
2.
White Petrolatum
Quantitynoffi
formula
3.
Super 
Refined
Cottonseed
238 gm
59.5gm
119 gm
4.
Super Renned olive_
LQ
14 gm
3.5 gm
7gm
63 om
5_
\/itamin F Anafota
. r 
, rvvtqtu
126 gIII
…
6.
Polymyxin B Sulfate
(non-sterile)
14.44 MU
3.61 MU
7.22 MU
7.
Neomycin Sulfate
(non-micronized)
19.992 gm
4.998 gm
gm
9.996 gm
8
Bacitracin Zinc
28.88 qm
7.22
14.44 gm
9
Empty  Lど赫
Printed   tubes   Of
corresponding s:zes
As per Packing policy

‐4-
一
（
S.No
Name
Of
Export Product
S.No
lnputs recommended
100 tubes
of14 gm
100 Tubes
of28 gm
9
Double
Antibiotic
W/PRAM
Cream
Emulsifying wax
168 gm
336 gm
2.
Mineral O‖
112 gm
224 gm
3.
White Petrolatum
56 gm
112 gm
4.
Poloxamer 188
0.0182 gm
0.0364 gm
5.
Propylene Glycol
28 gm
56 gm
6.
Methyl Paraben
3.5gm
7.00 gm
7.
Polymyxin B Sulfate (non-
sterile)
14.28 gm
28.56 gm
8.
Neomycin Sulfate (micronized)
4.998 gm
9.996 gm
9.
Pramoxine HCL Micronised
28.56 gm
14.28 gm
10.
Empty Laminated Printed tubes
of corresponding sizes
As per Packing Policy
S.No
Name of Export
Product
S.No
lnputs recommended
100 Tubes of
28 gm
10
Allergy WlZinc
Cream
Cetyl Alcohol
448
2.
84
3.
Sorbitan Monostearate
196
４
，
‐
pylene_GlycOI
140
5.
Methyl Paraben
7
6.
Diphenhydramine Hyd roch loride
57.12
7.
Zinc Acetate
2.856
8
Empty Laminated Printed tubes of
corresponding sizes
As per Packing
Policy
S.No
Name of Export
Product
S.No
lnputs recommended
100 Tubes
of 14 qm
100 Tubes
of28 gm
Double Antibiotic
Ointment
White Petrolatum
Quantities could not be
worked out as neither
the DML nor Batch
Formula provided in the
application.
2.
Polymyxin B Sulfate (non-
Sterile)
3.
Bacitracin Zinc
4.
Empty Larninated Printed

-5-
S.No Name of
Export
Product
S.No
lnputs recommended
100 Tubes of
14 gm
100 Tubes
of28 gm
12
Bacitracin Zinc
Ointment
White Petrolatum
Quantity not indicated
in the Batch formula
2
Bacitracin Zinc
9.025
18.05
3.
As per Packing Policy
S,No Name 
of
Export
Product
S.No
lnputs recommended
100 Tubes
of 28 gm
100 Tubes
of56 gm
13
Hydrocortisone
l%    OTC
Cream
I Glyceryl Stearate
I
I White wax
I Stearyl Alcohol
Itso[io@
lcetyP
lsoabffi
@
@
Anhydrous Citric Acid
Sodium ciirate
@
Sorbic ncio 
-
@
Propylene Glycol
Hvdrocortisone
The requirement of
various inputs not
tally with 
Batch
Formula and DML
available in 
the
application.
2.
3.
4.
5.
6.
7.
8.
9.
10.
12.
13.
14.
15.
16.
S.No Name of
Export
Product
S.No
lnputs recommended
100 Tubes of 28 gm
14
Hydrocortisone
l%   OTC
Ointment
Whne Petrolatum
2,716
2.
Mineral()il
0_0■6
3.
Hydrocortisone
28.56
4.
As per Packing
Policy
⌒

-6-
・
・
（
S.No
Name of Export
Product
S,No
lnputs recommended
100 Tubes
of28 gm
100 Tubes
of56 gm
15
Hydrocortisone/
Aloe 1o/o Cream
1
AnhydrOus Citttc Acid
0。98 gm
1.96 gm
2.
Sodium citrate
1.68 gm
3.36 gm
3.
lVlethyl Paraben
5.6gm
11.2gm
4.
SOrbic Acid
1.4gm
2.80m
5.
learate
14 gm
28 gm
6.
Propylen`≧GlycOI
98 gm
196 gm
7.
_Glyceryl Stearate
56 gm
112 gm
8.
White wax
84 gm
168 gm
9.
Stearyl Alcohol
28 gm
56 gm
10.
lsopropyl Myttstate
224 gm
448 gm
CetylAlcohol
84 gm
168 gm
12.
Sorbitan Monostearate
84 gm
168 gm
13.
-9te 60
84 gm
168 gm
14
Propyl Paraben
2.8gm
5.6gm
15.
Hydrocortisone
0.02856 gm
0.05712 gm
16
Aloe Concentrate
2.8 gm
5.6gm
17.
Empty LaminatedTrinted -
tubes of corresponding
sizes
As per Pacf-ngFoltcy
S.No
Name
Of
Export Product
S,No
lnputs recommended
100Tし,bes of28 gm
16
|:譜1兜竃lT
Anhydrous Citric Acid
0,980
2.
Sodium citrate
1.680
3.
Methyl Paraben
5.600
4
Sorbic Acid
1.400
5.
Polyoxy1 40
14.000
6.
|
98.000
7.
91y9eln
7.000
8.
plycerゾstearate
56.000
9.
White wax
84.000
10.
Stearyl Alcohol
28.000
lsop「opyl Myristate
224.000
12.
Sorbitan Monostearate
84.000
13.
Polysorbate 60
84.000
J
Propyl Paraben
2.800
15
Mineral()il
7.000
16
White Petrolatum
7.000
17
Cetosteryl Alcohol
7.00o
18.
IS鯉聖型Pttmlate
2.800
19.
Vitamin A&D3
7.000
20.
Aloe Concentrate
2.800
21.
Hydrocortisone
28.560
22.
Cetyl AlcohOI
84.000
23.
Empty Laminated printed tubes
of corresponding sizes
As per Packing policy

-7‐
⌒
●
　
０
Ｓ
Ｎ
Name of Export Product
S.No
lnputs recommended
100 Tubes of
56 gm
17
Hydrocortisone 0.5% Cream
Methyl Paraben
0.112 gm
2.
Sorbic Acid
0.056 gm
3.
Polyoxyl 40 Stearate
0.28 gm
4.
Glyceryl Stearate
1.12 gm
5.
White wax
1.68 gm
6
Stearyl Alcohol
0.56 gm
7.
lsopropyl A/1yristate_
4.48 gm
8.
Cetyl Alcohol
1.68 om
9.
Sorbitan Monostearate
1.68 gm
10.
Polysorbate 60
1.68 gm
Etopyl Paraben
0.056 om
12.
Propylene Glycol
1.12 gm
13.
Hydrocortisone
0.28 gm
14
As per Packing
Policy
3. 
This issues with the approval of Director (pharma lndustry).
Phone: -23071162
Email: - uspi3-pharma@nic.in

lζ
一
^、
ア
|∂
F No 3501 1120512016-Pl (Norms)
Government of lndia
udyog Bhawan,New Delhi,
Dated:|=rOCtOber,2016
Office Memorandum
Subject. - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of
M/s Aurobindo Pharma Ltd.
The undersigned is directed to refer to DGFT U.O.No. 011821501251/AM-17/DES-3/285
dated the 111712016 vide which application from M/s Aurobindo Pharma Ltd. was sent to this
Department for fixation of norms under para. 4.7 for the export of Amoxicillin and Clavulanate
Pot. 1000m9 Tablet. 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'.-
lmport item
Norms Recommended
for 1No. Tablet
Methvl acetoacetate
Methanol
mlne
Me
chloride
lso
alcohol
N,N―di
acednide
chloride
Clavulanate Potassium + Avicel / Pot. Clavulanate diluted
with mi
lline cellulose (1:1)(in active base
Under Secretary to the(3overnment oflndia
PH:-23071162
(Shri MV Singh,FTDO),
Udyog Bhawan, New Delhi.
roxvl phenvl qlvcine base
58177m
36545m
29928m
43120m
10140m
129.67m9A

降
一
引
IMeet NoノDate:9′82-
lALC4ノ2011
i31052011
## Case No.:13ノ52ノ82-
ALC4/2010
:Lic NoノDate10310621220
15032011
Eision : Committee considered c
rpartment of C&PC, Petrochen
.06.2010 and in consultation witl
der para 4.7 of HBP as Per detail
ase as per agenda and in light of written comments foruarded by
nicals Division vide their O.M. No.460111201201}-PC-ll dated
r technical authority present in meeting, decided to ratify norms
s below or as applied by firm whichever is lower:-
Export product
Exp. Qty.
SI No
lmport items
Qtv a‖ OWed
Epoxy Acrylate (80% Resin
content in GTPA (GlYceryl
Propoxy
Triacrylate/Propoxylated
Glyceryl Triacrylate)
l kg
Acrylic Acid
0.2217 kg
2
Eooxv Resins
0 5827 kg
3
Mono Ethyl Hydro Quinone
0.0061 kg
4
BDMA (Benzyl Dimethyl
Amine)        ____
0.0040 kg
5
Glyceryl PropoxY TriacrYlate
Propoxylated GlYceryl
Triacrvlate)
0 1920 kg
concerned may take further necessary action as per above decision of NC.
fon″arded by
:03/95/040ノ00970/AMllノ
~日稿輛雨膀~
|
:01/82ノ050/01782/ノヽMl1/

髪
F No.3501 1 12812016-Pl (Norms)
Government of lndia
Dated: August,2016
Office Memorandum
subject. - Fixation of norms under para 4.7 of Hand Book of procedures (vol.l) 2009-14
Case of M/s Zim Labs Ltd.
The undersigned is directed to refer to DGFT U o.No. 01t\2tsol1g3olAM-16/DES-
3/20 dated the 4t4116 vide which application trom tVVs zim Labs Ltd. was sent to thrs
Department for fixatron of norms under para: 4.7 for the export of prednisolone
orodispersible DC Granules Smg. 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:_
Both the Export description as well as net content of prednisolone Bp in each of the two
export products do not match with the DML furnished by the firm.
Technica luStrication a10ngwtth rev sed details may be fumished by the lrm
2 
Under Secretary to the Govern#ilji,ffi?
PH: 23071162
(Shri M.V Singh, FTDO),

/S
■″
・
F. No.3501 1 126912016-Pl (Norms)
Government of lndia
τlι
Dated: 6 SeOtember, 20'16
Office Memorandum
## Subject: - Fixation of norms under para4.7 of Hand Book of Procedures (Vol l) 2009-14 Case of
M/s Orch Labs lndia Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O.No. 011821501905/AM-16/DES-3i445
dated lhe231812016 vide which application from M/s Orch Labs lndia Pvt. Ltd. was sent to this
Department for fixation of norms under para.4.7 for the export of (2R,5R)-5-hydroxy-[1,3]-
oxathiolane-2-carboxylic acid-2S-isopropyl-5R-methyl-1R-cyclohexyl ester. 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:-
(Ralkumar)
Under Secretary to the Government oflndla
PH:-23071162
(Shri MV Singh,FTDO),
Udyog Bhawan, New Dethi.
S No
lmport item
Norms Recommended
for 1kq Export
0 70kq
2
mclohexane
1 067kΩ
3
2, 5-dihydroxy- 1,4-dithiane
0 283kg
4
Tri9¨
0 015kg
5
Toluene
0 60kq
6
n-Hexane
0 79kq
2

ヘ
ニ
多召
F. No.350 1 1 I 17 412016-Pl (Norms)
Government of lndia
Dated: f September, 2016
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of procedures
(Vol.l) 2009-'14 Case of M/s Divi,s Labs Ltd.
The undersigned is directed to refer to DGFT U.o.No.
0118215011788/AM-16/DES-3/548 dated the 6/9/2016 vide which application
from M/s Divi's Labs Ltd. was sent to this Department for fixation of norms
under para: 4.7 for the export of Levetiracetam. This department has
examined the matter and the following norms are furnished under para 4.7 of
Hand Book of Procedures (Vol.l) 2O0g-14:-
2. 
(Rajldumar)
Under Secretary to the Government oflndia
PH:-23071162
Directorate(3eneral of Foreign Trade,
Depattment of Commerce,
(Shri M.∨.Singh,FTDO),
Udyog Bhawan,New Delhi.
S No
lmport item
Norms Recommended
for 1kg Export
1
ldin… 1-プ)
1.84kg
2
D-(+)-alpha phenyl ethylamine
0.35kg
3
Triethylamine
1 17kg
4
Ethyl chloro formate
1 06kg
5
Toluene
1.33kg
6
Methylene chloride
4 1lkg
7
|
1 1lkg
8
Acetone
1.05kg

GoveFnmOnt oflndia
Minisuy of chetnicals and Fertilizers
Department oF Chemicals arld Petrochetllloats
%
SubreCヒ
・
　
　
　
　
卜
ヽ
・
ヽ
Advance Authorizatiori applicatiorufrorn lvUs. Tlde lndustries for the import of raw
material against the export of Rose OXde etc.
The applicationrhas been examined and the Depa(ment recommonds the following
norms for lhe present Advane Authorization applicaiion.
Tht issues M4h the approval of competent euthonty.
ょ、
κ場
し
1.itern Of.日輝"n ~~~~「
011:
ttem of,lmoort
Qtv
Aldehyde cl‐ 2 LauHc
1‐ kg
1.C‐12Ta餞,AIc●ho【L3uryl AlcohoD
1.725:k9

′多
^
gv
F. No.3501 1 120912016-Pl (Norms)
Government of lndia
∪dyog Bhawan,New Delhi,
Dated: , September,2016
0ffice Memorandum
## Subject:― Fixation of norms tlnder para 4.7 of Hand Book of Procedures(∨
ol l)2009-14 Case
of M′s Divi's Labs Ltd.
The undersigned is directed to refer to DGFT U.○.No.01/82/50/1859/AA/1-16メDES―
3/412 dated the 18/8/2016 vide which application from A/1/s Divi's Labs Ltd.was sent to this
Department for fixation of norrns under parai 4.7 forthe export of Dextromethorphan Base.
This department has exarllined the rnatter and the fo‖ owing norrrns are furnished under para
4 7 of Hand Book of Procedures(∨
ol。|)2009-14:―
item
Norms Recommended for 1
octabase
horus
oxide
Toluene
Methanol
0824k
Acetone
0420k
2
(Ralkumar)
Under Secretary to the Government oflndia
PHi-23071162
(Shri M V. Singh, FTDO),
Udyog Bhawan, New Delhi.
1.
1.

工
如
多
F. No.3501 1119012016-Pl -Norms
Government of lndia
New Delhi. the
Office Memorand um
Shastri Bhawan,
3o S-j , 2016
## Subject: - Fixation of norms under para 4.7 ol Hand Book of Procedures (Vol.l) 2009-14
Case of M/s Cadila Pharmaceuticals Ltd.
The undersigned is directed to refer to DGFT U.O. No. 01/821050/00179/AM-
17|DES-31287 dated the 1110712016 vide which application from M/s Cadila
Pharmaceuticals Ltd. was sent to this Department for fixation of norms under para. 4.7
for the export of lsoniazid 100 mg Tablet. 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: -
Item
Norms Recommended
102.0 mg/ '100 mg Tablet
2) This issues with the approval of competent authority.
(Raj Kumar)
Phone. -23071162
Email: uspi3-pharma@ n ic in
Department of Commerce
(Shri M.V. Singh, FTDO).
Udyog Bhawan, New Delhr-110011
「
コ
∃

■
,3
効ご
F No 35011/191/2016-PI(Norms)
Government oflndia
Ministry Of Chemical&Fertilizers
Department Of Pharmaceuticals
Datedi 3ο ヽく¬
Fノ  '2016
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of procedures (Vol.l) 2009-i4
Case of M/s Jubilant Generics Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01lB2lSOt277tAM-17|DES-
3/289 dated the 111712016 vide which application from M/s Jubitant Generics Ltd. was
sent to this Department for fixation of norms under para: 4.7 for the export of
Escitalopram Smg, 10m9, 20mg Tablets. 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:-
2
Under Secretary to the Government ofindia
PH:-23071162
(shn M∨singh,FTDO),
Udyog Bhawan,New Delhi
S No
lmport item
Norms Recommended
1
Escitalopram Oxalate
6 515mg/5mg Tablets
Or
13 03mg/1omg Tablets
Or
26 06mg/20mg Tablets

′
ヘ
孫
F. No 3501 1119512016-Pl -Norms
Government of lndia
Shastl Bhawan,
1多0び、/2016
Office Memorandum
## Subject: - Fixation of norms under para 4 7 of Hand Book of Procedures (Vol.l) 2009-14
Case of M/s Cadila Pharmaceuticals Ltd.
The undersigned is directed to refer to DGFT U.O. No. 01/821050/00178/AM-
17lDES-3/2BB dated the 11t07t2016 vide which application from M/s Cadila
Pharmaceuticals Ltd. was sent to this Department for fixation of norms under para 4 7
for the export of Baclofen 10 mg and 25 mg Tablet. This department has examined
the mattei and the following noir. ur" furnished under para 4.7 of Hand Book of
Procedures (Vol.l) 2009-14 -
lmport ltem
Norms Recommended
Baclofen
10.2 mg I
mg Tablet
2550m
Tablet
New Delhi,the
‐
０
＆
２
５
2)This issues with the approval of competent authority.
(Ra1 Kumar)
Phone: -23071162
Email: usPi3-Pha rma@n ic in
Depanment Of COmmerce
(Shl M∨Singh,FTDO),
Udyog Bhawan,New Delh l10011
剛
「
―
―
「
―
LJ

β
一
ｐ
F No 35011/164ノ2016-PI(Norms)
Government of!ndia
Ministry Of Chemical&Fertilizers
Department of Pharmaceulcals
Udyog Bhawan,New Delhi,
Dated:IЪ OctOber,2016
0ffice Memorandum
Sublect:― Fixation of norms under para 4 7 of Hand Book of Procedures(∨ol l)2009-14
-― Case of M′ s Cadi!a Pharmaceuticals Ltd.
The undersigned is directed to referto DGFT∪
O No 01/82/50ノ180/AM-17/DES―
3/265 dated the 8/7/2016 vide which applicatiOn from Mノ
s Cadila Pharmaceuticals Ltd
was sent to this Department for fixation of norms under para: 4 7 for the export of
Acic:ovir 200mg&400mg Tablets.This department has examined the matter and the
fo‖ owing norms are furnished under para 4 7 of Hand Book of Procedures(∨
ol l)2009-
14■
S No
lmport item
Norms Recommended
1
Acic ovir BP
204 0mg/200mg Tablet
And
408 0mq/400mq Tablet
う
４
∪nder Secretary to the Government ofindia
PH■23071162
Directorate Ceneral of Foreign Trade,
Depanment Of Commerce,
(shn M∨singh,FTDO),
Udyog Bhawan,New Delhi

lЪ
一
多■ζ%Ч%
F No.3501 1I18812016-Pl (Norms)
Government of lndia
Dated: 1$ October,2016
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14
--Case of M/s Glenmark Pharmaceuticals Ltd.
The undersigned is directed to refer to DGFT U.O.No. 011821501317 & 578/AM-
17lDES-3/262 & 535 dated lhe 81712016 & 5t9t2016 vide which application from M/s
Glenmark Pharmaceuticals Ltd. was sent to this Department for fixation of norms under
para'. 4.7 for the export of Gabapentin 600mg, 800mg Tablets. 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.-
This issues with the approval of compete
Under Secretary to the Covernment oflndia
PH:-23071162
Udyog Bhawan, New Dellti.
S No
１
一
２
lmport item
Norms Recommended for
Export of 1No. Tablet
600m9 Tablet
800mg Tablet
Gabapentin
612 0mg
816 0mg
Poloxamer 407
75.Omg
100 0mg
3
Copovidone
60 0mg
80 0mg
4
53mm securx (R) ribbed side text top,
white plastic (plastic closure)
Relevant, As per packing PolicY
5
38mm securx (R) ribbed side text top,
white plastic (plastic closure)
2

⌒
ハ
F No.350 11 116612016-Pl -Norms
Government of lndia
IЪ
プ
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case
of M/s Cadila Healthcare Ltd'
The undersigned is directed to refer to DGFT U.o. No. 01/82l050i00188/AM-17/DES-
31255 dated the 08/07/2016 vide which application from M/s Cadila Healthcare Ltd was sent
to this Department for fixation of norms under para. 4.7 for the exporl of Perphenazine
Tablets 2*g, 4 ,g, 8 mg and 16 mg. This department has examined the matter and the
folowing norms arelurnishLd under pala 4.7 of Hand Book of Procedures (Vol'l) 2009-14' -
lmport ltem
Perphenazine USP
1632
Cellulose(COmpiecel M101D十)
面百      bTこπPharmatose 200 M)
3100
Malze Starch(Corn Starch)
1920
Hyd roxyproPYl Cellu lose
Microcrystal百ne celluloSe(COmprecel
M1012D+
Magnesium Stearate
2) This issues with the approval of competent authority.
New Delhi,the
Under SecretarY to the
Email:
Shastri Bhawan,
September 26,2016
Government of lndia
Phone: -23071162
uspi3-pharma@nic.in
Directorate General of Forelgn Trade,
Depanment Of COmmerce〕
踏:y諒鼻:RI判｀hM 10“ 1
Norms Recommended for 1 No.
Tablet(Qtv.in
25740
12870
S.No
2 mg
4 mg
8 mg
16 rng
204
4.08
816
32.175
6435
２
　
一
３
3875
7750
155.0
４
．
一
ａ
240
480
960
240
480
960
1920
1875
375
750
1500
6
0400
0800
1.60
320
7

二
響
F. No.350 1 1 I 19gl201 6-Pl -Norms
Government of lndia
Shastri Bhawan,
New Delhi, the 3o S"-p , 2016
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14
Case of M/s Cadila Healthcare Ltd.
The undersigned is directed to refer to DGFT U.O. No. 011821050/0019s/AM-
17lDES-3/281 dated the 1110712016 vide which application from M/s Cadila Healthcare
Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of
Gabapentin 600 mg Tablets and 800 mg Tablets. 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 -
SI.No
L
2-
a
CaOapentin tlS
Manntol USP
CopovOoneNf
4
Pov!done USP
5
Hydroxypropyl
6
Magnesium St
7 to 16
Packing Ma
一
ｍ
P
一
■
て
port ltem
For Export of 1 No. Tabl
600 mg
800 mg
612.0 mg
816.0
75.375 mg
100.50
54.00 mg
72.00
K-30)
26.25 mg
35.00 rrl
ellulose (Low Substitute)
41.25 mg
55.00 rrl
rate
12.24 mg
16.32 rn
ls in Finished Forrn
Relevant, As per packing
Policv
ea
teria-
2) This issues with the approval of competent authority
(Raj Kumar)
Phone: -23071162
Email: uspi3-pharma@nic. in
Udyog Bhawan, New Delhi-110011

l3
u02
t=. No.350 1 1 I 17 1 12016-Pl -Norms
Government of lndia
Shastri Bhawan,
New Delhi, the 3o S.f / 2016
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14
Case of M/s Fresenius Kabi Oncology Ltd.
The undersigned is directed to refer to DGFT U O. No. 01lB2l050l0022BlAM-
17IDES-3/276 dated the 08/07t2016 vide which application from M/s Fresenius Kabi
Oncology Ltd. was sent to this Department for fixation of norms under para. 4.7 for the
export of Cytarabine lnjections 2gm and 1gm. This department has examined the
matter and the following norms are furnished under paz 4.7 of Hand Book of
Procedures (Vol.l) 2009-14 -
S. No
lmp
Cytarabine.Ph E
2
Glass∨ials
3
Rubber
ort ltem
For Export of 1 No.
2 gml 20
tir′ USP′ IP
2.10 gm
Stoppers
Relevant, As per Packing PolicY
2) This issues with the approval of competent authority.
Phone: -23071162
Email: usPi3-Pharma@nic. in
(Shri M.V Singh, FTDO),
Udyog Bhawan, New Delhi-110011
1 gm/ 10 ml
1 10 gm

多
匂夕S
F No 35011119412016-Pl -Norms
Government of lndia
New Delhilthe
Shastri Bhawanl
lЪ ο辟。′2016
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol'l) 2009-14
Case of M/s Cadila Pharmaceuticals Ltd'
The undersigned is directed to refer to DGFT U.O. No. 011821050100227lAM-
.17lDEll-3/295 dated the 13107t2016 vide which application from M/s Cadila
pharmaceuticals Ltd. was sent to this Department for fixation of norms under para'. 4'7
for the export of clarithromycin 250 mg and 500 mg Tablets. This department has
examined the matter and the following iorms are furnished under para 4-7 of Hand
Book of Procedures (Vol.l) 2009-14'. -
Eur
「
‐
一
2) This issues with the approval of competent authority'
Under Secretary to the Government of India
Phone: -23071162
Email: usPi3-Pharma@nic' in
Department of Commerce
Udyog Bhawan, New Delhi-1 1001'1
lmport ltem
Clar性hromycin Ph

‘
υ
「W¨ 面[麒
『
…脚続
I          P4.04.2014
Decision : Committee considered case as per agenda and in consultation with technical
iauthOrity prcscnt in mccting,decidcd to ratify nolllls undcr Para 4.7 of HBP vl as pcr
lSION A-2611,as per details givcn below or as applied by thc f11111,whichevcr is less:
,RA concerned may take further necessary action as per above decision of NC.
Export Product
Export
Qty.
SI.
No.
Import Items
Qtv.
allowed
2-Amino methyl-7-chloro-
2,3-Dihydro-5-(2-
Fluorophenyl) -1 H-1,4-
B enzo diazepine D imaleate
lKg.
1
2-Amino-5-chloro-2-
Fluoro Benzophenone
0.932 Kg.
2.
Chloro acetaldehvde
Dimethyl acetal
0.696 Kg.
3.
Manganese Dioxide
0.852 Kg.
4.
Dimethyl Sulfoxide
0.405 Kg.
5.
Acetone
0.405 Kg.
К
ｆ
Status:Case
Approved

lζ _
L4ヴ多
ハ
ILic No/Date:3110056651
一
　
ａ一
Ｄ
一
た
一
Ｄ
:31/83/040/00168/AM13/
102012013
Partv Name:MELZER
CHEMICALS PVT LTD
No.:74/33/82-A LC4/2012
. IHQ Filc
.  :01/82/050/01221/ANl13/
ALC4/2013
16052013
) ratrty norms under Para 4.7 of HtsP vl as per detarls glven below or as
rm. whichever is less:
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. allowed
Benzalkonium
Chloride 80%
l kg
l
Lauryl Dimethyl Amine
0.513 kg
may take appropriate action as per the decision of Norms Committee.
」
|

‘
一
牧
F.No.3501 1 I 18812016-Pl (Norms)
Government of lndia
Dated: \$ OctoOer,2016
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14
--Case of M/s Glenmark Pharmaceuticals Ltd.
The undersigned is directed to refer to DGFT U.O.No. 011821501583/AM-17/DES-
3t521 dated lhe 5lgl2}'16 vide which application from M/s Glenmark Pharmaceuticals
Ltd. was sent to this Deparlment for fixation of norms under para: 4.7 for the export of
Pravastatin Sodium 10mg, 20mg, 40mg, 80mg Tablets. 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.-
m
Norms Recommended for Export of 1No.
Tablet
1Omg
20mg
40mg
80mg
n
10 2mq
20.4m9
40.8mq
81 60mq
ito1 25 C
104 005mq
104.005m9
207.92mg
416.02mq
ribbed
e plastic
iaceuticats
irbbed
e plastic
Relevant, As per Packing PolicY
PH'.- 23071162
Department of Commerce.
(Shri MV Singh,FTDO),
Udyog Bhawan, New Delhi.
Pravastatin sodiur
Mannito1 25(Pearl
S.No
2
3
4
5

⌒
ll 多
僣
|  ICase No.:135/23/82-    Party Namc:NS       Mcct No/Datc:1/82‐    Status:Casei
l  ‐ALC4/2013          CHEMICALS        
‐ALC4/2014        Approved l
`                            .                        110042014            1           '
|  ‐HQ File            lRLA Filc           Lic.No/Datc:03107531071Dcfcr Datc:|
|    :01/82/050/01182/AM14/   :03/95/040/00535/AM14/   1010.2013                        1
1  1Decision:ln the light of wntten cOmments received from Department of ChemicaL andl
I    Petrochemica:s vide their u.O No. 14010/4/2010-Ch ‖ dated 25.03.2014′  it was decided to
lH8『|=轟‖:!:rerPa餞
47 of HBP vl as per de面
にgven bdOw Or as ap口たd by me■rm′
|
I  RA may take appropnate ac●
on as perthe deciJon of Norms Commttee.
ion : ln the light of written comments received from Department of Chemicals a
:hemicals vide their U.O No. l4OtO/4120L0-Ch ll dated 25.03.20L4, it was decided
norms under Para 4.7 of HBP v1 as per details given below or as applied by the fit
ever is less:
Export product
賄
い
Sl.No.
Import items
Qty. allowed
Sodium Sacchann
(USP)
l kg
1
Sodium Saccharin
1.02 kg
RA may take appropriate action as per the decision of Norms Committee.

,~―
F. No.350 1 1 121612016-Pl (Norms)
Government of lndia
Dated:6p \ October, 2016
Office Memorandum
## Subject - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14
Case of M/s Saurav Chemicals Ltd.
The undersigned is directed to refer to DGFT U.O.No. 011821501666/AM-17/DES-
3/563 dated the 711012016 vide which application from M/s Saurav Chemicals 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 (Vol.l) 2009-
14.-
―
―
暮
働
S,No.
lmport item
Norms Recommended
for 1kg Exporl
4
Levofloxacin Q-acid
0.8571kg
2
Dimethvl sulfoxide
0.2193kg
3
Methanol
0.88kg
Under Secretary to the Government oflndia
PH:-23071162
\
Udyog Bhawan, New Delhi.
一
´
・
１
，
‐
〓
・
ｒ
2.

ιヌ
一
ハ
切gЪ
F.No.35011/174/2016-PI(Norms)
Government oflndia
Ministry of Chemical&Fertilizers
∪dyog Bhawan,New Delhi,
Dated:g September,2016
0ffice Memorandum
SubieCt: ― Fixation of norrlls under para 4 7 of Hand Book of Procedures
(∨01.|)2009… 14 Case of M′ s Divi's Labs Ltd.
The  undersigned  is  directed  to  refer  to  DGFT  UO.No.
01/82/50/599/AM-17/DES-3/542 dated the 6/9/2016 vide whlch applicatiOn
from A/1/s Divi's Labs Ltd was sent to this Department for fixation of norms
under para: 4.7 for the export of Valacyuc!ovir Hcl.This department has
exarnined the rnatter and the fo‖ owing norrns are furnished under para 4.7 of
Hand Book of Procedures(∨ol.|)2009-14:―
2. 
PH.- 23071162
Udyog Bhawan, New Delhi.
S.No
lmport item
Norms Recommended
Acyclovir
0 758kq
2
N,N― dicyclohexyl carbod‖ nlide
1.061kq
3
Forrrl!c acld-94%
0.15kq
4
Dimethyl formamide
1.60kq
5
Acetone
5.90kq
6
Z― L―∨aline
1 1824kg
7
Palladium metal
0.50grn/kg

（
（
t9
'r#
F No.3501 1 17 112016-Pl (Norms)
Government of lndia
Dated'..!(> September, 20 1 6
Office Memorandum
Subject. - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14
Case of M/s Enaltec Labs (P) Ltd.
The undersigned is directed to refer to DGFT U.O.No. 011821501567lAM-17/DES-
31523 dated the 51912016 vide which application from M/s Enaltec Labs (P) Ltd. was
sent to this Department for fixation of norms under para: 4.7 for the export of
Dronedarone Hcl . 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.
lmport item
Norms Recommended
for 1kq Export
1
N-butvl-N-(3-chloropropyl) butan- I -amine
0.74kg
2
(2-butyl-5-n itrobe nzofu ran-3-yl) (4-hyd roxy phenyl)
methanone
1.14k9
PH'.- 23071162
Udyog Bhawan, New Delhi.
2

身
F.No.3501 1 17 17 12015-Pl (Norms)
Government of lndia
Depaftment of Pharmaceuticals
Udyog Bhawan, New Del,hi,
Daled.f\ October, 2016
Office Memorandum
Subject. - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14
Case of M/s Vadivarhe Speciality Chemicals Ltd.
The undersigned is directed to refer to DGFT U.O.No. 011821501713/AM-'17/DES-
31564 dated the 711012016 vide which application from M/s Vadivarhe Speciality
Chemicals Ltd. was sent to this Department for fixation of norms under para: 4.7 for lhe
export of 2-Amino-4-Hydroxy Acetophenone Hcl. 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-
2
Under Secretary to the Government oflndia
PH:-23071162
S.No.
lmport item
Norms Recommended
for 1kq Export
1
Amino acetonitrile Hcl
0.628kq
2
Nitromethane
1.416kg
3
Phenol
0 70kq
4
lsopropyl alcohol
1.00kq

⌒
尾
一
瑚
画
1常″盤
『
鵬島澪
50Ю∝
47/A田″
~~臨
脇蕊ゝ
mン
~
1239
Decision : In the light of written comments received from Department of
Pharmaceuticals vide their OM No. 3501llll9l20l3-Pl(Norms) dated 25.4.2013, it was
decided to ratiff nonns under Para 4.7 of HBP vl as per details given below or as applied
by the firm, whichever is less:
Export product
恥
Ｏ
ｔ
ｖ
．
SI.No.
Import items
Qty. allowed
Montelukast
Sodium
l kg
1
2 - (2 -3 S -3,2,7 -Chlor o -2 -
Quinolinyl)-Ethynylphenyl)-
3 -Hydroxy Propyl)-Ph enyl-2-
Propanol
1.424 kg
2
1 -(Mercapto Methyl)- 1 -
Cyclopropane Acetic Acid
0.52 kg
RA may take appropriate action as per the decision of Norms Committee.

ハ
IZ
5%
|
125
## Case No.:4/20/82‐ ALC4/2013 Party Name:MICRO INKS   IMeet No/Date:20/82-   Status:Case
lLTD                IALC4/2013         1Approved
‐16.01.2014            1
HQ File              lRLA File             Lic.No/Date:0310755766 1Defer Date:
:01/82/050/00990/AM14/      :03/95/040/00556/AM14/      128.10.2013             
‐
Decision:In thc light of earlier decision takcn irlmecting no.33/82 datcd 21.03.2013,it
was decided to ratltt nollllS undCr Para 4.7 of HBP vl as per details glven below or as
applicd by the f11111,whiChCvcr is lcss:
Export product
Exp
Qtv
SI.No.
lmport items
Qtv.
allowed
Adhesion 
Promoter
containing 62 + 1o/o Tetra
lsopropyl Titanate and 27 +
1% Butanol
l MT
Butanol
0.2786 MT
2
Tetra lsopropyl Titanate
0 6302 MT
3.
lsopropanol
0.1100 MT
may take appropriate action as per the decision of Norms Committee.

1多
5Ч ο
「
FMF~ぽ
赫
赫
yttFぽ
FF
I翻脇扁議i扁~麗
脇蕊屁鳳島~|    
四而~
Decision : Committee considered case as per agenda and in light of earlier decision taken in
meeting no.24182 dated 15.11.2012 and in consultation with technical authority present in
meeting, decided to ratifo norms under para 4.7 of HBP as per details below or as applied by
firm whichever is Iower:-
Export Product
Export
Qty.
SI.No.
lmport items
Qty.
a‖owed
kg/kg
M!PD KETAL(lE)-1-(2′
5′ 5-
丁rimethyl-1,3-Dioxane-2-
yリー
PrOpane-1′ 2-D:one-1-
(0-methyl ox:me)
l kg
1
Acetyl Acetone
0.578
2.
Methyl Tertiary Butyl Ether
(MttBE HP 99.9 PCT)
0.583
3.
Di Methyl Formamide
0.300
4.
Neo Pentvl Glycol(NPG)
0.503
5.
Potassium Carbonate Granule
0.950
6.
Sodium N忙百te
0.412
7.
Toluene
0.273
8じ/=
Methanol
0.258
RA may take appropriate action as per the decision of Norms committee.
339
per
■
■
４
事
事
週

夕
5吻多
Office Memorandum
subiect: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol'l) 2009-14
Case of M/s Divi's Labs Ltd'
TheundersignedisdirectedtorefertoDGFTU.o.No.oltB2lS,ot653/AM-17/DES-
3/5s6 dated th" ,iii/201-6 vide *r'ii lppr,.rt,on tlopivr)'"o'ui;r.t'.':^ttd was sent to
this Department toi n*tion of no,rJ'rffJ;';;i;' 4 ? f;;il" "-p"" 
of Atovaquone' This
d e pa rtme nt las "-?T'1"^1i::^I il,*lilS i[i1lil#; 
noi,'' "'" 
ru rn ished u nd e r p a ra
,T:「胤臨謡ド牌dした
SⅣd⇒2009-44-
I lvlelrtat tut 
n
Thisissueswiththeapprovalofcompetentauthority.y
(RaJkumarl
Under Secretary tO the(3oVe:11::::;IT:3
」
」
一
一
´
一
一
2.
Directorate General of Foreign Trade'
DePartment of Commerce'
rs{,i rtn.v. singh, FTDO)'
Uir"n enrw'i, New Delhi
つ_ch10ro-1,41
ヽ

移
一
（
　
亀
ヽ
」
∫レ
F. No.350'1 1 121 1 12016-pt (Norms)
Government of lndia
Department of pharmaceuticals
Dated:Q !October,2016
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2OOg-14
Case of M/s Hetero Labs Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01t}2li)l641;AM-17/DES-
31542 dated the 3i1012016 vide which application from M/s Hetero Labs Ltd. was sent to
this Department for fixation of norms under para. 4.7 for the export of 3-Amino-2-
Chloro-4-Methyl Pyridine. This department has examined the matter and the following
norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2O0g-14.-
2.
S.No.
lmport item
Norms Recommended
for 1kg Export
malononitrile
0.93kg
2
Phosphorous oxy£ hloride
1.32kg
3
Ethylene dichloride
2.92kq
4
Acetone
2.70kq
5
Methanol
1.42kq
\
(Rajkumar)
Under Secretary to the(3overnment oflndia
PH:-23071162
p・
 |

移
一
″
「
   
而
~1蘊
聴
酬
需
秤
距
F雨
丁
甲
蘇
‐
1    -―
 
―
              
―
― ‐ ― 一―
―一――一
― ―
―
―
一
爾‰蕊
204/AMW~~臨璃蕊蕊丁丁1冨鼎α“Ю
ttZ
Decision : In the light of written comments received from Department of Chemicals and
Petrochemicals vide their U.o No. 1401\lg2l2olllch. II datedi3.l2.20l, it was decided to
ify n0111ls under Para 4.7 of HBP vl as per details given below Or as applied by the f11111,
lichever is iess:
Export Product
Export
Quantitv
S.No
Import Product
Quantity
Allowed
Meta Chloro Benzo Tri
Fluoride (MCBTF)
l kg
1
Benzo Tri Fluoride
(BTF)
0.899 kg
I(A may take appropriate ac1 10n
appropriate
as per the decision of Norms Committee.

⌒
ド
一
鍋
IRLA File
113/24/040/00011/AM14/
ICase No.:1/13/82-
:01/82/050/00477/AM14/
ecision : ln the ligh
le their U.O No. 1501
HBP v1 as per details
t of written comments received from Department of Chemicals and Petrochemicals
L0/2L/20L2-Ch. lt dated 05.0g.2013, it was decided to ratify norms under para 4.7
given below or as applied by the firm, whichever is less:
Export product
ｐ
ｙ
Ｅ
Ｘ
Ｑ
SIoNo.
lmport items
Qty. allowed
2-CYANIMIN0 1′ 3
丁HIAZOLIDIN(CI丁)
l kg
1
Cysteamine Hydrochlori de 95%
Min
1.122 kg
2.
Dirnethyl N―Cyanodithioimino
Carbonate(CCI丁M)
1.384 kg
3.
Toluene
0.108
RA may take appropriate action as per the decision of Norms Corritt".

==い
´´
⌒
  
後
ヽタ
貯
´
〆
F No 3501 1t49t t7lt5-pt (Norms)
Government of lndia
It/linistry of Chemical & Fertilizers
Shastri Bhawan, New Delhr,
Dated December 23. Z01S
e f rise* [&, rrcGtd_u_!:)
sublect' - Fixation of norms under para 47 of Hand Book of procedures (Vol.l) 2aog-14
Case of M/s Alembic pharma Ltd.
The undersigned is drrected to refer to DGFT U.o. No. 01ll2l50t537lAM-16/DES-
3/588 dated the 1410711 5 vide whrch applicatron from M/s Alembic pharma Ltd was sent to
this Department for fixation of norms under para 47 for the export of lrbesartan Tablets
in 75 Mg, 150 Mg &-300 Mg strengths. This department has exarnined the matter and the
following norms are furnished under para 4.7 of Hand Book of procedures (Vol l) 2oog-14..-
~~査
亙■ё逮五i通h墾画 ~~ ~¬
For l No Tablet
75mq 1 16omq 1 300高q
０
　
一
Ｎ
Ｓ
一
lmport ltem
||「besartan
Lactose Monohydrate (Granulac-200)
153m9
306m9
12475m9124950m9
1400m91 2800mg
225mg 1 450mg
2
3
0おもしち品aるも
e s66も品いこ戯sめ
765m9
62 375 mg
7 00 rn9
1 125m9
| "..-*-.. | .-..-.....
: 4 rfulagnesiuni
L_. _._1 ,
IMagnesitlm Stearate
Department of Conrmerce,
(Shri MVSingh,FTDO),
Udyog Bhawan. New Delhi
This issues with the approvat of competent ar.rthority 
I)
V
Under Secretary to the """"rrJffi
Phone. 23011162
つ
４