IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2017-02-09

DGFT Committee Minutes

Document text

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

Para 4.7 Decision

Meeting No. 17/82/2016 of 2016-17 dated 24.01.2017 to consider the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products and falling under Chapter 29 and 30, scheduled to be held on 24.01.2017 but actually held on 09.02.2017 under the Chairmanship of Shri J.V. Patil, Addl. DGFT in Room No.04, Udyog Bhawan, New Delhi. Following members were present:- Shri Nirmal Kumar, Dy. Director General of Foreign Trade Shri V.K. Tyagi, Consultant, D/o Pharmaceuticals. The committee went through the minutes of earlier meeting No. 16/82 dated 28.12.2016 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 : 17/82-ALC4/2016 MEETING DATE : 24.01.2017 1

Case No.:104/17/82-

ALC4/2016 Party Name:BALAJI AMINES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01065/AM17/ RLA File :31/83/040/00184/AM13/ Lic.No/Date:3110057358 07.03.2013 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.40/82 dated 03.01.2012 , 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. 2

Case No.:60/17/82-

ALC4/2016 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01021/AM17/ RLA File :09/24/040/00021/AM14/ Lic.No/Date:0910055945 07.05.2013 Defer Date:08.03.2017 Decision :Deferred for comments from DoP.

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Case No.:17/4/82-ALC4/2014

Party Name:NAPROD LIFE SCIENCES PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00265/AM15/ RLA File :03/95/040/00563/AM14/ Lic.No/Date:0310754049 17.10.2013 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/680/2015-PI(Norms) dated 29.03.2016, 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. 4

Case No.:18/23/82-ALC4/2013 Party Name:NAPROD LIFE

SCIENCES PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01065/AM14/ RLA File :03/95/040/00712/AM14/ Lic.No/Date:0310760768 05.12.2013 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/680/2015-PI(Norms) dated 29.03.2016, uploaded 5

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

Party Name:SNF [INDIA] PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00966/AM17/ RLA File :26/24/040/00012/AM14/ Lic.No/Date:2610012456 27.02.2014 Defer Date:08.03.2017 Decision :Deferred. 6

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

Party Name:UPL LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00454/AM15/ RLA File :03/95/040/01043/AM14/ Lic.No/Date:0310776594 01.04.2014 Defer Date: taken by NC in its meeting No.4/82 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 7

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

Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00490/AM15/ RLA File :03/95/040/00033/AM15/ Lic.No/Date:0310782129 20.05.2014 Defer Date: taken by NC in its meeting No.4/82 dated 16.05.2013, uploaded at the end of these minutes or as 8 Case No.:61/4/82-ALC4/2014 Party Name:V & V PHARMA INDUSTRIES Meet No/Date:17/82- ALC4/2016 Status: Deferred

3 24.01.2017 HQ File :01/82/050/00309/AM15/ RLA File :03/95/040/00190/AM15/ Lic.No/Date:0310785305 13.06.2014 Defer Date:08.03.2017 Decision : Deferred. 9

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

Party Name:D. R. COATS INK & RESINS PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00870/AM15/ RLA File :03/94/040/00755/AM14/ Lic.No/Date:0310786181 30.06.2014 Defer Date:08.03.2017 10

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

Party Name:METROPOLITAN EXIMCHEM LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00876/AM15/ RLA File :03/95/040/00337/AM15/ Lic.No/Date:0310787073 18.07.2014 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.5/82 dated 30.05.2013 for same export product , 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. 11

Case No.:396/5/82-

ALC4/2015 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00536/AM16/ RLA File :17/24/040/00047/AM15/ Lic.No/Date:1710005887 24.07.2014 Defer Date:08.03.2017 12

Case No.:32/9/82-ALC4/2014 Party Name:CHEMCON

SPECIALITY CHEMICALS P LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00829/AM15/ RLA File :34/24/040/00102/AM15/ Lic.No/Date:3410040406 28.07.2014 Defer Date:08.03.2017 13

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

Party Name:V & V PHARMA INDUSTRIES Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00410/AM15/ RLA File :03/95/040/00331/AM15/ Lic.No/Date:0310787382 28.07.2014 Defer Date:08.03.2017 14

Case No.:31/9/82-ALC4/2014 Party Name:AMBERNATH

ORGANICS PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00828/AM15/ RLA File :03/94/040/00074/AM15/ Lic.No/Date:0310787610 04.08.2014 Defer Date:08.03.2017

4 15

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

Party Name:SHREE SHIVSHANKAR DRUGS & PHARMACEUTICALS P. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01138/AM16/ RLA File :03/95/040/00425/AM15/ Lic.No/Date:0310788055 14.08.2014 Defer Date: taken by NC in its meeting No.20/82 dated 16.08.2011, uploaded at the end of these minutes or as 16

Case No.:215/13/82-

ALC4/2014 Party Name:GOLD STAR CHEMICALS PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01218/AM15/ RLA File :03/94/040/00358/AM15/ Lic.No/Date:0310788338 25.08.2014 Defer Date: taken by NC in its meeting No.14/82 dated 05.07.2011, uploaded at the end of these minutes or as 17

Case No.:224/13/82-

ALC4/2014 Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01227/AM15/ RLA File :03/94/040/00391/AM15/ Lic.No/Date:0310788515 28.08.2014 Defer Date:08.03.2017 18

Case No.:225/13/82-

ALC4/2014 Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01228/AM15/ RLA File :03/94/040/00397/AM15/ Lic.No/Date:0310788514 28.08.2014 Defer Date:08.03.2017 19

Case No.:262/13/82-

ALC4/2014 Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01265/AM15/ RLA File :03/94/040/00971/AM14/ Lic.No/Date:0310788560 01.09.2014 Defer Date: taken by NC in its meeting No.24/82 dated 27.03.2014, uploaded at the end of these minutes or as 20 Case No.:223/13/82- ALC4/2014 Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:17/82- ALC4/2016 Status: Deferred

5 24.01.2017 HQ File :01/82/050/01226/AM15/ RLA File :03/94/040/00508/AM15/ Lic.No/Date:0310788647 02.09.2014 Defer Date:08.03.2017 21

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

Party Name:S V CHEM INTERMEDIATES P LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00647/AM15/ RLA File :04/24/040/00139/AM15/ Lic.No/Date:0410159328 02.09.2014 Defer Date: taken by NC in its meeting No.09/82 dated 20.10.2014, uploaded at the end of these minutes or as 22

Case No.:400/5/82-

ALC4/2015 Party Name:YASH RASAYAN & CHEMICALS Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00540/AM16/ RLA File :34/24/040/00120/AM15/ Lic.No/Date:3410040554 15.09.2014 Defer Date:08.03.2017 23

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

LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01299/AM15/ RLA File :03/94/040/00460/AM15/ Lic.No/Date:0310789265 16.09.2014 Defer Date: taken by NC in its meeting No.29/82 dated 18.10.2011, uploaded at the end of these minutes or as 24

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

Party Name:GEM AROMATICS PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01545/AM15/ RLA File :03/94/040/00594/AM15/ Lic.No/Date:0310789922 01.10.2014 Defer Date: taken by NC in its meeting No.1/82 dated 10.04.2014, uploaded at the end of these minutes or as 25

Case No.:29/13/82-

ALC4/2014 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01032/AM15/ RLA File :05/23/040/00268/AM15/ Lic.No/Date:0510391490 08.10.2014 Defer Date:08.03.2017

6 26

Case No.:124/13/82-

ALC4/2014 Party Name:PANACEA BIOTEC LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01127/AM15/ RLA File :05/24/040/00319/AM15/ Lic.No/Date:0510391623 17.10.2014 Defer Date:08.03.2017 27

Case No.:198/5/82-

ALC4/2015 Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00338/AM16/ RLA File :04/24/040/00205/AM15/ Lic.No/Date:0410159704 11.11.2014 Defer Date:08.03.2017 28

Case No.:25/18/82-ALC4/2014 Party Name:S.M. CHEMICALS Meet No/Date:17/82-

ALC4/2016 24.01.2017 Status: approved HQ File :01/82/050/01391/AM15/ RLA File :03/95/040/00580/AM15/ Lic.No/Date:0310791081 14.11.2014 Defer Date: taken by NC in its meeting No.16/82 dated 21.11.2013, uploaded at the end of these minutes or as 29

Case No.:126/8/82-

ALC4/2015 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00922/AM16/ RLA File :03/94/040/00710/AM15/ Lic.No/Date:0310791177 18.11.2014 Defer Date:08.03.2017 30

Case No.:70/17/82-ALC4/2016 Party Name:ASTRIX

LABORATORIES LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01031/AM17/ RLA File :09/24/040/00423/AM15/ Lic.No/Date:0910061278 20.11.2014 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/181/2015-PI(Norms) dated Sept. 2015 for same export product , 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. 31

Case No.:145/5/82-ALC4/2015 Party Name:JINDAL DRUGS

PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00285/AM16/ RLA File :03/94/040/00877/AM15/ Lic.No/Date:0310792112 17.12.2014 Defer Date: taken by NC in its meeting No.24/82 dated 15.11.2012, uploaded at the end of these minutes or as

7 32

Case No.:127/5/82-ALC4/2015 Party Name:EMAMI LIMITED, Meet No/Date:17/82-

ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00267/AM16/ RLA File :02/24/040/00183/AM15/ Lic.No/Date:0210205355 18.12.2014 Defer Date: taken by NC in its meeting No.08/82 dated 24.05.2011, uploaded at the end of these minutes or as 33

Case No.:221/5/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00361/AM16/ RLA File :09/24/040/00537/AM15/ Lic.No/Date:0910061442 23.12.2014 Defer Date:08.03.2017 34

Case No.:114/5/82-

ALC4/2015 Party Name:NATIONAL TUBE INDUSTRIES, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00254/AM16/ RLA File :03/95/040/00756/AM15/ Lic.No/Date:0310792363 24.12.2014 Defer Date:08.03.2017 35

Case No.:218/5/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00358/AM16/ RLA File :09/24/040/00552/AM15/ Lic.No/Date:0910061462 29.12.2014 Defer Date:08.03.2017 36

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

SCIENCES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00185/AM16/ RLA File :09/24/040/00558/AM15/ Lic.No/Date:0910061483 05.01.2015 Defer Date:08.03.2017 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/01/2016-PI(Norms) dated 01.06.2016 from the firm and deferred the case. 37

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

LABORATORIES LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00242/AM16/ RLA File :03/94/040/00836/AM15/ Lic.No/Date:0310792635 07.01.2015 Defer Date: taken by NC in its meeting No.10/82 dated 05.06.2012, uploaded at the end of these minutes or as

8 38

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

Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00214/AM16/ RLA File :03/95/040/00833/AM15/ Lic.No/Date:0310792647 07.01.2015 Defer Date: taken by NC in its meeting No.46/82 dated 14.02.2012, uploaded at the end of these minutes or as 39

Case No.:149/5/82-

ALC4/2015 Party Name:ALCHEMIE LABORATORIES Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00289/AM16/ RLA File :03/94/040/00813/AM15/ Lic.No/Date:0310792673 08.01.2015 Defer Date:08.03.2017 40

Case No.:62/5/82-ALC4/2015

Party Name:INDO AMINES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00202/AM16/ RLA File :03/94/040/00928/AM15/ Lic.No/Date:0310792678 08.01.2015 Defer Date: its meeting No.17/82 dated 05.12.2013 for same export product , 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 41

Case No.:219/5/82-

ALC4/2015 Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00359/AM16/ RLA File :09/24/040/00549/AM15/ Lic.No/Date:0910061517 09.01.2015 Defer Date:08.03.2017 Decision :Deferred. 42

Case No.:112/5/82-

ALC4/2015 Party Name:UNIMAX CHEMICALS PVT LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00252/AM16/ RLA File :03/95/040/00812/AM15/ Lic.No/Date:0310793039 19.01.2015 Defer Date:08.03.2017 Decision : The Committee noted that an investigation in the matter is under process. The Committee accordingly, decided to defer the case. 43

Case No.:88/5/82-ALC4/2015 Party Name:ABEERS

PHARMACEUTICALS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File RLA File Lic.No/Date:0510392949 Defer

9 :01/82/050/00228/AM16/ :05/23/040/00486/AM15/ 21.01.2015 Date:08.03.2017 44

Case No.:138/8/82-

ALC4/2015 Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 45

Case No.:275/5/82-

ALC4/2015 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00415/AM16/ RLA File :03/94/040/00930/AM15/ Lic.No/Date:0310793539 03.02.2015 Defer Date:08.03.2017 46

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

CHEMICALS PVT.LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: approved HQ File :01/82/050/00419/AM16/ RLA File :03/94/040/01088/AM15/ Lic.No/Date:0310793983 19.02.2015 Defer Date: taken by NC in its meeting No.49/82 dated 06.03.2012, uploaded at the end of these minutes or as 47

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

CHEMICALS PVT.LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00428/AM16/ RLA File :03/94/040/01089/AM15/ Lic.No/Date:0310793982 19.02.2015 Defer Date: taken by NC in its meeting No.49/82 dated 06.03.2012, uploaded at the end of these minutes or as 48

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

LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00475/AM16/ RLA File :03/95/040/00978/AM15/ Lic.No/Date:0310794038 20.02.2015 Defer Date: taken by NC in its meeting No.21/82 dated 23.08.2011, uploaded at the end of these minutes or as 49 Case No.:334/5/82-ALC4/2015 Party Name:UPL LTD.(FORMERLY UNITED Meet No/Date:17/82- ALC4/2016 Status: Approved

10 PHOSPHORUS LTD.) 24.01.2017 HQ File :01/82/050/00474/AM16/ RLA File :03/95/040/00862/AM15/ Lic.No/Date:0310794100 24.02.2015 Defer Date: taken by NC in its meeting No.23/82 dated 01.11.2012, uploaded at the end of these minutes or as 50

Case No.:309/5/82-

ALC4/2015 Party Name:SHREE VALLABH CHEMICAL Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00449/AM16/ RLA File :08/24/040/00417/AM15/ Lic.No/Date:0810134670 25.02.2015 Defer Date:08.03.2017 51

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

Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00114/AM16/ RLA File :09/24/040/00564/AM15/ Lic.No/Date:0910061653 26.02.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/266/2015-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. 52

Case No.:61/17/82-

ALC4/2016 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01022/AM17/ RLA File :09/24/040/00607/AM15/ Lic.No/Date:0910061652 26.02.2015 Defer Date:08.03.2017 53

Case No.:273/5/82-

ALC4/2015 Party Name:BHARAT SERUMS & VACCINES LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00413/AM16/ RLA File :03/94/040/01055/AM15/ Lic.No/Date:0310794262 27.02.2015 Defer Date:08.03.2017 Decision :Deferred for DBT. 54

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

ORGANICS PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00592/AM16/ RLA File :03/94/040/01091/AM15/ Lic.No/Date:0310794261 27.02.2015 Defer Date: taken by NC in its meeting No.11/82 dated 14.06.2011, uploaded at the end of these minutes or as

11 55

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

INDUSTRIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00435/AM16/ RLA File :08/24/040/00395/AM15/ Lic.No/Date:0810134703 03.03.2015 Defer Date: taken by NC in its meeting No.03/82 dated 19.04.2011, uploaded at the end of these minutes or as 56

Case No.:303/5/82-

ALC4/2015 Party Name:ASSOCIATED DYESTUFF PVT. LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00443/AM16/ RLA File :08/24/040/00422/AM15/ Lic.No/Date:0810134739 05.03.2015 Defer Date:08.03.2017 57

Case No.:300/5/82-

ALC4/2015 Party Name:ADVANCE PETROCHEMICALS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00440/AM16/ RLA File :08/24/040/00448/AM15/ Lic.No/Date:0810134768 11.03.2015 Defer Date:08.03.2017 58

Case No.:447/5/82-

ALC4/2015 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00587/AM16/ RLA File :03/94/040/01131/AM15/ Lic.No/Date:0310794543 12.03.2015 Defer Date:08.03.2017 59

Case No.:40/7/82-ALC4/2015

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00645/AM16/ RLA File :07/24/040/00351/AM15/ Lic.No/Date:0710107812 13.03.2015 Defer Date: taken by NC in its meeting No.08/82 dated 25.09.2014, uploaded at the end of these minutes or as 60

Case No.:291/5/82-ALC4/2015 Party Name:JUBILANT LIFE

SCIENCES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00431/AM16/ RLA File :05/23/040/00544/AM15/ Lic.No/Date:0510393616 18.03.2015 Defer Date: taken by NC in its meeting No.07/82 dated 27.06.2013, uploaded at the end of these minutes or as

12 61

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

ORGOCHEM (INDIA) PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00323/AM16/ RLA File :03/95/040/00964/AM15/ Lic.No/Date:0310794811 23.03.2015 Defer Date: taken by NC in its meeting No.49/82 dated 06.03.2012, uploaded at the end of these minutes or as 62

Case No.:29/5/82-ALC4/2015 Party Name:ASSOCIATED

DYESTUFF PVT. LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00169/AM16/ RLA File :08/24/040/00483/AM15/ Lic.No/Date:0810134917 25.03.2015 Defer Date:08.03.2017 63

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

Party Name:BIOLOGICAL E LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00121/AM16/ RLA File :09/24/040/00663/AM15/ Lic.No/Date:0910061841 31.03.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/74/2015-PI(Norms) dated Sept. 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. 64

Case No.:26/5/82-ALC4/2015 Party Name:CONTINENTAL

CHEMICALS Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00166/AM16/ RLA File :08/24/040/00470/AM15/ Lic.No/Date:0810134992 07.04.2015 Defer Date:08.03.2017 65

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

Party Name:VIVIMED LABS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00175/AM16/ RLA File :09/24/040/00739/AM15/ Lic.No/Date:0910061891 17.04.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/576/2014-PI(Norms) dated April 2015, uploaded 66

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

TROTTERS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred

13 HQ File :01/82/050/00737/AM16/ RLA File :03/94/040/00024/AM16/ Lic.No/Date:0310795429 20.04.2015 Defer Date: 08.03.2017 Decision : Information called for from the firm in NC meeting No.07/82 dated 07.07.2016 is awaited. The Committee accordingly deferred the case. 67

Case No.:40/8/82-ALC4/2015 Party Name:SYNTHO

CHIRALS PVT. LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00836/AM16/ RLA File :09/24/040/00042/AM16/ Lic.No/Date:0910061937 27.04.2015 Defer Date:08.03.2017 Decision :Deferred. 68

Case No.:75/8/82-ALC4/2015 Party Name:PORUS

LABORATORIES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00871/AM16/ RLA File :09/24/040/00051/AM16/ Lic.No/Date:0910061986 06.05.2015 Defer Date:08.03.2017 Decision :Deferred. 69

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

Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Rejected HQ File :01/82/050/00861/AM16/ RLA File :09/24/040/00052/AM16/ Lic.No/Date:0910061973 06.05.2015 Defer Date: Decision : The Committee noted that Information was called for from the firm in NC meeting No.03 dated 12.05.2016 but same has not been received. In absence of the above case cannot be decided. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC. 70

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

Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Rejected HQ File :01/82/050/00147/AM16/ RLA File :05/23/040/00037/AM16/ Lic.No/Date:0510394177 08.05.2015 Defer Date: Decision : The Committee noted that Information was called for from the firm in NC meeting No.03 dated 12.05.2016 but same has not been received. In absence of the above information norms cannot be decided. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC. 71

Case No.:97/8/82-ALC4/2015 Party Name:ASCENT

FINECHEM PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00893/AM16/ RLA File :08/24/040/00051/AM16/ Lic.No/Date:0810135338 22.05.2015 Defer Date:08.03.2017 Decision :Deferred. 72 Case No.:109/17/82- ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE Meet No/Date:17/82- ALC4/2016 Status: Approved

14 LIMITED, 24.01.2017 HQ File :01/82/050/01070/AM17/ RLA File :07/24/040/00038/AM16/ Lic.No/Date:0710108249 22.05.2015 Defer Date: taken by NC in its meeting No.10/82 dated 05.06.2012, uploaded at the end of these minutes or as 73

Case No.:110/17/82-

ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01071/AM17/ RLA File :07/24/040/00039/AM16/ Lic.No/Date:0710108252 22.05.2015 Defer Date: taken by NC in its meeting No.08/82 dated 25.09.2014, uploaded at the end of these minutes or as 74

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

Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Rejected HQ File :01/82/050/00841/AM16/ RLA File :05/24/040/00073/AM16/ Lic.No/Date:0510394342 25.05.2015 Defer Date: Decision : The Committee noted that Information was called for from the firm in NC meeting No.20 dated 09.03.2016 but same has not been received. In absence of the above case cannot be decided. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC. 75

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

LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00882/AM16/ RLA File :09/24/040/00131/AM16/ Lic.No/Date:0910062091 29.05.2015 Defer Date:08.03.2017 Decision :Deferred. 76

Case No.:187/7/82-

ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 77

Case No.:24/13/82-

ALC4/2016 Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00652/AM17/ RLA File :09/24/040/00034/AM16/ Lic.No/Date:0910062155 10.06.2015 Defer Date:08.03.2017 Decision :Deferred.

15 78

Case No.:121/8/82-ALC4/2015 Party Name:NEW ALLIANCE

DYE-CHEM PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00917/AM16/ RLA File :03/95/040/00190/AM16/ Lic.No/Date:0310796766 23.06.2015 Defer Date: taken by NC in its meeting No.46/82 dated 14.02.2012, uploaded at the end of these minutes or as 79

Case No.:89/7/82-ALC4/2015 Party Name:HALDIA

PETROCHEMICALS LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00694/AM16/ RLA File :02/24/040/00045/AM16/ Lic.No/Date:0210205925 26.06.2015 Defer Date:08.03.2017 Decision :Deferred. 80

Case No.:97/14/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01233/AM16/ RLA File :09/24/040/00186/AM16/ Lic.No/Date:0910062271 01.07.2015 Defer Date:08.03.2017 Decision :Deferred. 81

Case No.:65/17/82-ALC4/2016 Party Name:INDO PHYTO

CHEMICALS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01026/AM17/ RLA File :05/23/040/00007/AM16/ Lic.No/Date:0510394777 02.07.2015 Defer Date: its meeting No.07/82 dated 24.07.2015 for same export product , uploaded at the end of these 82

Case No.:108/17/82-

ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01069/AM17/ RLA File :07/24/040/00112/AM16/ Lic.No/Date:0710108483 08.07.2015 Defer Date: taken by NC in its meeting No.08/82 dated 25.9.2014, uploaded at the end of these minutes or as 83

Case No.:111/17/82-

ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01072/AM17/ RLA File :07/24/040/00111/AM16/ Lic.No/Date:0710108489 08.07.2015 Defer Date:

16 taken by NC in its meeting No.23/82 dated 01.11.2012, uploaded at the end of these minutes or as 84

Case No.:50/8/82-ALC4/2015 Party Name:PUSILIN

BIOTECHNOLOGY PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00846/AM16/ RLA File :06/24/040/00014/AM16/ Lic.No/Date:0610038189 09.07.2015 Defer Date:08.03.2017 Decision :Deferred for comments from DBT. 85

Case No.:54/14/82-

ALC4/2015 Party Name:BIOLOGICAL E LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01190/AM16/ RLA File :09/24/040/00524/AM15/ Lic.No/Date:0910062332 15.07.2015 Defer Date:08.03.2017 Decision :Deferred for comments from DBT. 86

Case No.:59/14/82-

ALC4/2015 Party Name:BIOLOGICAL E LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01195/AM16/ RLA File :09/24/040/00525/AM15/ Lic.No/Date:0910062331 15.07.2015 Defer Date:08.03.2017 Decision :Deferred for comments from DBT. 87

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

INDUSTRIES Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00845/AM16/ RLA File :06/24/040/00015/AM16/ Lic.No/Date:0610038193 16.07.2015 Defer Date:08.03.2017 Decision :Deferred. 88

Case No.:49/14/82-

ALC4/2015 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01185/AM16/ RLA File :09/24/040/00205/AM16/ Lic.No/Date:0910062344 17.07.2015 Defer Date:08.03.2017 Decision :Deferred. 89

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

PHARMACEUTICALS LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Rejected HQ File :01/82/050/01175/AM16/ RLA File :05/23/040/00165/AM16/ Lic.No/Date:0510395004 20.07.2015 Defer Date: Decision : The Committee noted that Information was called for from the firm in NC meeting No.03 dated 12.05.2016 but same has not been received. In absence of the above case cannot be decided. The Committee accordingly decided to reject the case. RA

17 concerned may take further necessary action as per decision of NC. 90

Case No.:38/14/82-ALC4/2015 Party Name:SUN

PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01174/AM16/ RLA File :05/24/040/00115/AM16/ Lic.No/Date:0510395018 21.07.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/781/2015-PI(Norms) dated October 2015, 91

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

PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Rejected HQ File :01/82/050/01341/AM16/ RLA File :09/24/040/00223/AM16/ Lic.No/Date:0910062361 22.07.2015 Defer Date: Decision : The Committee noted that Information was called for from the firm in NC meeting No.05 dated 08.06.2016 but same has not been received. In absence of the above case cannot be decided. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC. 92

Case No.:50/14/82-ALC4/2015 Party Name:SRIAM LABS

PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01186/AM16/ RLA File :09/24/040/00226/AM16/ Lic.No/Date:0910062363 23.07.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/757/2015-PI(Norms) dated 02.05.2016, uploaded 93

Case No.:1/10/82-ALC4/2015 Party Name:SALICYLATES

& CHEMICALS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00957/AM16/ RLA File :09/24/040/00211/AM16/ Lic.No/Date:0910062393 28.07.2015 Defer Date:08.03.2017 Decision :Deferred. 94

Case No.:131/14/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01267/AM16/ RLA File :09/24/040/00212/AM16/ Lic.No/Date:0910062413 30.07.2015 Defer Date:08.03.2017 Decision :Deferred. 95

Case No.:60/14/82-

ALC4/2015 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred

18 HQ File :01/82/050/01196/AM16/ RLA File :09/24/040/00256/AM16/ Lic.No/Date:0910062418 31.07.2015 Defer Date:08.03.2017 Decision :Deferred. 96

Case No.:84/1/82-ALC1/2016 Party Name:CADILA

PHARMACEUTICALS LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 97

Case No.:169/14/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01305/AM16/ RLA File :31/83/040/00018/AM16/ Lic.No/Date:3110065573 03.08.2015 Defer Date:08.03.2017 Decision :Deferred. 98

Case No.:17/8/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00813/AM16/ RLA File :09/24/040/00251/AM16/ Lic.No/Date:0910062426 03.08.2015 Defer Date:08.03.2017 99

Case No.:168/14/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01304/AM16/ RLA File :31/83/040/00024/AM16/ Lic.No/Date:3110065579 04.08.2015 Defer Date:08.03.2017 100

Case No.:18/14/82-

ALC4/2015 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01154/AM16/ RLA File :03/95/040/00317/AM16/ Lic.No/Date:0310798039 10.08.2015 Defer Date:08.03.2017 101

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

Party Name:ALPHAMED FORMULATIONS P LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Rejected HQ File :01/82/050/00819/AM16/ RLA File :09/24/040/00091/AM16/ Lic.No/Date:0910062478 11.08.2015 Defer Date: Decision : The Committee noted that information was called for from the firm in NC meeting No.03 dated 12.05.2016 but such information has not been received so far. In absence of the above norms cannot be decided. The Committee decided to reject the

19 102

Case No.:155/14/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01291/AM16/ RLA File :05/24/040/00237/AM16/ Lic.No/Date:0510395271 11.08.2015 Defer Date:08.03.2017 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/781/2015-PI(Norms) dated 26.04.2016, uploaded at the end of these minutes and deferred the case. 103

Case No.:11/18/82-

ALC4/2015 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01476/AM16/ RLA File :03/95/040/00327/AM16/ Lic.No/Date:0310798117 13.08.2015 Defer Date:08.03.2017 Decision :Deferred. 104

Case No.:34/14/82-

ALC4/2015 Party Name:TRANSPEK INDUSTRY LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01170/AM16/ RLA File :34/24/040/00144/AM16/ Lic.No/Date:3410041464 17.08.2015 Defer Date:08.03.2017 Decision :Deferred. 105

Case No.:99/14/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status:Rejected HQ File :01/82/050/01235/AM16/ RLA File :09/24/040/00231/AM16/ Lic.No/Date:0910062516 18.08.2015 Defer Date: meeting No.03 dated 12.05.2016 but such information has not been received so far. In 106

Case No.:56/13/82-

ALC4/2015 Party Name:PANACEA BIOTEC LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01019/AM16/ RLA File :05/24/040/00183/AM16/ Lic.No/Date:0510395354 18.08.2015 Defer Date:08.03.2017 Decision :Deferred for comments from DBT. 107

Case No.:154/14/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred.

20 108

Case No.:68/14/82-

ALC4/2015 & CHEMICALS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01204/AM16/ RLA File :09/24/040/00368/AM15/ Lic.No/Date:0910062518 19.08.2015 Defer Date:08.03.2017 Decision :Deferred. 109

Case No.:24/14/82-

ALC4/2015 Party Name:SHUBHAM SPECIALTY PRODUCTS Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01160/AM16/ RLA File :03/95/040/00348/AM16/ Lic.No/Date:0310798516 27.08.2015 Defer Date:08.03.2017 Decision :Deferred. 110

Case No.:82/14/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 111

Case No.:89/14/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 112

Case No.:94/14/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 113

Case No.:116/16/82-

ALC4/2015 Party Name:PANERA BIOTEC PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01436/AM16/ RLA File :05/24/040/00181/AM16/ Lic.No/Date:0510395496 01.09.2015 Defer Date:08.03.2017 Decision :Deferred for comments from DBT. 114

Case No.:93/14/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017

21 Decision :Deferred. 115

Case No.:124/7/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00298/AM17/ RLA File :03/94/040/00424/AM16/ Lic.No/Date:0310798671 04.09.2015 Defer Date:08.03.2017 Decision :Deferred. 116

Case No.:52/14/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status:Rejected HQ File :01/82/050/01188/AM16/ RLA File :09/24/040/00323/AM16/ Lic.No/Date:0910062554 04.09.2015 Defer Date: meeting No.03 dated 12.05.2016 but such information has not been received so far. In 117

Case No.:56/14/82-

ALC4/2015 & CHEMICALS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 118

Case No.:46/14/82-

ALC4/2015 Party Name:MALWA OXYGEN & INDUSTRIAL GASES PVT.LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01182/AM16/ RLA File :56/24/040/00005/AM16/ Lic.No/Date:5610004674 09.09.2015 Defer Date:08.03.2017 Decision :Deferred. 119

Case No.:157/14/82-

ALC4/2015 Party Name:AETHER INDUSTRIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01293/AM16/ RLA File :52/24/040/00042/AM16/ Lic.No/Date:5210041630 10.09.2015 Defer Date:08.03.2017 Decision :Deferred. 120

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

Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Rejected HQ File :01/82/050/01329/AM16/ RLA File :09/24/040/00328/AM16/ Lic.No/Date:0910062593 11.09.2015 Defer Date: meeting No.05 dated 08.06.2016 but such information has not been received so far. In

22 121

Case No.:8/14/82-ALC4/2015 Party Name:PRIVI

ORGANICS LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 122

Case No.:110/14/82-

ALC4/2015 & CHEMICALS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 123

Case No.:134/14/82-

ALC4/2015 & CHEMICALS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 124

Case No.:74/14/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 125

Case No.:15/14/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status:Approved HQ File :01/82/050/01151/AM16/ RLA File :03/95/040/00360/AM16/ Lic.No/Date:0310798909 15.09.2015 Defer Date: taken by NC in its meeting No.39/82 dated 27.12.2011, uploaded at the end of these minutes or 126

Case No.:9/14/82-ALC4/2015 Party Name:PERFECT

VITAMINS PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01145/AM16/ RLA File :03/95/040/00434/AM16/ Lic.No/Date:0310798944 16.09.2015 Defer Date:08.03.2017 Decision :Deferred.

23 127

Case No.:124/14/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 128

Case No.:35/16/82-

ALC4/2015 Party Name:D. R. COATS INK & RESINS PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01355/AM16/ RLA File :03/94/040/00415/AM16/ Lic.No/Date:0310798977 21.09.2015 Defer Date:08.03.2017 Decision :Deferred. 129

Case No.:34/16/82-

ALC4/2015 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status:Rejected HQ File :01/82/050/01354/AM16/ RLA File :03/94/040/00472/AM16/ Lic.No/Date:0310798979 21.09.2015 Defer Date: meeting No.03 dated 12.05.2016 but such information has not been received so far. In 130

Case No.:64/21/82-

ALC4/2015 Party Name:CADILA HEALTHCARE LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01769/AM16/ RLA File :08/24/040/00137/AM16/ Lic.No/Date:0810136085 22.09.2015 Defer Date:08.03.2017 Decision :Deferred. 131

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

PHARMA LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Rejected HQ File :01/82/050/01200/AM16/ RLA File :09/24/040/00375/AM16/ Lic.No/Date:0910062644 22.09.2015 Defer Date: meeting No.20 dated 09.03.2016 but such information has not been received so far. In 132

Case No.:117/14/82-

ALC4/2015 Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01253/AM16/ RLA File :04/24/040/00140/AM16/ Lic.No/Date:0410161044 22.09.2015 Defer Date:08.03.2017 Decision :Information received from the firm and sent to DoP for comments. The Committee accordingly deferred the case.

24 133

Case No.:103/14/82-

ALC4/2015 Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Rejected HQ File :01/82/050/01239/AM16/ RLA File :09/24/040/00362/AM16/ Lic.No/Date:0910062635 22.09.2015 Defer Date: meeting No.03 dated 12.05.2016 but such information has not been received so far. In 134

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

PHARMACEUTICALS PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Rejected HQ File :01/82/050/01608/AM16/ RLA File :13/24/040/00027/AM16/ Lic.No/Date:1310047981 23.09.2015 Defer Date: meeting No.11 dated 07.08.2016 but such information has not been received so far. In 135

Case No.:106/14/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01242/AM16/ RLA File :09/24/040/00373/AM16/ Lic.No/Date:0910062649 23.09.2015 Defer Date:08.03.2017 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. 136

Case No.:91/14/82-

ALC4/2015 Party Name:CURETECH SKINCARE Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01227/AM16/ RLA File :22/21/040/00029/AM16/ Lic.No/Date:2210015316 24.09.2015 Defer Date:08.03.2017 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. 137

Case No.:86/14/82-

ALC4/2015 Party Name:BELLAPREMIER HAPPY HYGIENECARE PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01222/AM16/ RLA File :35/24/040/00005/AM16/ Lic.No/Date:3510044794 25.09.2015 Defer Date:08.03.2017 Decision : The Committee noted that information has been called for from the firm in NC meeting No.09/82 dated 10.08.2016 is awaited. The Committee decided to await the reply and deferred the case.

25 138

Case No.:79/14/82-

ALC4/2015 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01215/AM16/ RLA File :05/23/040/00274/AM16/ Lic.No/Date:0510395773 30.09.2015 Defer Date:08.03.2017 Decision :Deferred. 139

Case No.:69/16/82-

ALC4/2015 Party Name:PIDILITE INDUSTRIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01389/AM16/ RLA File :03/95/040/00350/AM15/ Lic.No/Date:0310799113 30.09.2015 Defer Date:08.03.2017 Decision :Deferred. 140

Case No.:43/16/82-

ALC4/2015 Party Name:INDOFIL INDUSTRIES LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 141

Case No.:139/14/82-

ALC4/2015 Party Name:MAMTA POLYCOATS Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01275/AM16/ RLA File :34/24/040/00178/AM16/ Lic.No/Date:3410041581 08.10.2015 Defer Date:08.03.2017 Decision :Deferred. 142

Case No.:126/16/82-

ALC4/2015 DYE-CHEM PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01446/AM16/ RLA File :03/95/040/00445/AM16/ Lic.No/Date:0310799287 08.10.2015 Defer Date: taken by NC in its meeting No.46/82 dated 14.02.2012, uploaded at the end of these minutes or 143

Case No.:62/16/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01382/AM16/ RLA File :03/95/040/00491/AM16/ Lic.No/Date:0310799292 08.10.2015 Defer Date:08.03.2017 Decision :Deferred. 144 Case No.:164/14/82- ALC4/2015 Party Name:AASHA BIOCHEM Meet No/Date:17/82- ALC4/2016 Status: Deferred

26 24.01.2017 HQ File :01/82/050/01300/AM16/ RLA File :10/24/040/00049/AM16/ Lic.No/Date:1010059293 12.10.2015 Defer Date:08.03.2017 Decision : The Committee noted that information has been called for from the firm in NC meeting No.05/82 dated 08.06.2016 is awaited. The Committee decided to await the reply and deferred the case. 145

Case No.:140/14/82-

ALC4/2015 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 146

Case No.:132/14/82-

ALC4/2015 Party Name:RIDDHI PHARMA Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 147

Case No.:116/13/82-

ALC4/2016 Party Name:SOFTGEL HEALTH CARE PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00744/AM17/ RLA File :04/24/040/00143/AM16/ Lic.No/Date:0410161132 20.10.2015 Defer Date:08.03.2017 Decision :Deferred. 148

Case No.:72/16/82-

ALC4/2015 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01392/AM16/ RLA File :03/95/040/00102/AM16/ Lic.No/Date:0310799579 21.10.2015 Defer Date:08.03.2017 Decision :Deferred. 149

Case No.:73/16/82-

ALC4/2015 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01393/AM16/ RLA File :03/95/040/00087/AM16/ Lic.No/Date:0310799578 21.10.2015 Defer Date:08.03.2017 Decision :Deferred. 150

Case No.:29/16/82-

ALC4/2015 & CHEMICALS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01349/AM16/ RLA File :09/24/040/00379/AM16/ Lic.No/Date:0910062768 23.10.2015 Defer Date:08.03.2017

27 Decision :Deferred. 151

Case No.:30/16/82-

ALC4/2015 & CHEMICALS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 152

Case No.:129/16/82-

ALC4/2015 Party Name:SURVIVAL Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01449/AM16/ RLA File :03/95/040/00505/AM16/ Lic.No/Date:0310799628 23.10.2015 Defer Date:08.03.2017 Decision :Deferred. 153

Case No.:161/14/82-

ALC4/2015 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01297/AM16/ RLA File :03/94/040/01226/AM15/ Lic.No/Date:0310799680 26.10.2015 Defer Date:08.03.2017 Decision :Deferred. 154

Case No.:78/16/82-

ALC4/2015 Party Name:MOHINI ORGANICS PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 155

Case No.:31/16/82-

ALC4/2015 Party Name:MSN LABORATORIES PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01351/AM16/ RLA File :09/24/040/00423/AM16/ Lic.No/Date:0910062790 28.10.2015 Defer Date:08.03.2017 Decision : The Committee noted that information has been called for from the firm in NC meeting No.05/82 dated 08.06.2016 is awaited. The Committee decided to await the reply and deferred the case. 156

Case No.:74/16/82-

ALC4/2015 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01394/AM16/ RLA File :03/95/040/00518/AM16/ Lic.No/Date:0310799705 28.10.2015 Defer Date:08.03.2017 Decision :Deferred. 157 Case No.:75/16/82- Party Name:SURVIVAL Meet No/Date:17/82- Status:

28 ALC4/2015 TECHNOLOGIES PVT.LTD. ALC4/2016 24.01.2017 Deferred HQ File :01/82/050/01395/AM16/ RLA File :03/95/040/00525/AM16/ Lic.No/Date:0310799704 28.10.2015 Defer Date:08.03.2017 Decision :Deferred. 158

Case No.:47/16/82-

ALC4/2015 Party Name:SURVIVAL Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01367/AM16/ RLA File :03/95/040/00526/AM16/ Lic.No/Date:0310799853 29.10.2015 Defer Date:08.03.2017 Decision :Deferred. 159

Case No.:136/14/82-

ALC4/2015 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Rejected HQ File :01/82/050/01272/AM16/ RLA File :05/23/040/00293/AM16/ Lic.No/Date:0510396078 30.10.2015 Defer Date: meeting No.03/82 dated 12.05.2016 but same has not furnished by firm. In absence of the above information norms cannot be decided. The Committee decided to reject the 160

Case No.:48/16/82-

ALC4/2015 Party Name:O C SPECIALITIES PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01368/AM16/ RLA File :03/95/040/00549/AM16/ Lic.No/Date:0310799873 30.10.2015 Defer Date:08.03.2017 Decision :Deferred. 161

Case No.:159/14/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01295/AM16/ RLA File :05/24/040/00343/AM16/ Lic.No/Date:0510396075 30.10.2015 Defer Date:08.03.2017 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/781/2015-PI(Norms) dated 26.04.2016, uploaded at the end of these minutes and deferred the case. 162

Case No.:118/16/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01438/AM16/ RLA File :05/24/040/00345/AM16/ Lic.No/Date:0510396076 30.10.2015 Defer Date:08.03.2017 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/781/2015-PI(Norms) dated 26.04.2016, uploaded at the end of these minutes and deferred the case.

29 163

Case No.:72/17/82-ALC4/2016 Party Name:GLOBAL

CALCIUM PRIVATE LIMITED, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: approved HQ File :01/82/050/01033/AM17/ RLA File :07/24/040/00253/AM16/ Lic.No/Date:0710108986 02.11.2015 Defer Date: taken by NC in its meeting No.08/82 dated 25.09.2014, uploaded at the end of these minutes or 164

Case No.:112/16/82-

ALC4/2015 Party Name:BELCO PHARMA Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01432/AM16/ RLA File :05/23/040/00273/AM16/ Lic.No/Date:0510396205 03.11.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/798/2015-PI(Norms) dated June 2016, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per decision of NC. 165

Case No.:107/16/82-

ALC4/2015 Party Name:HELLO PAINTS (P) LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 166

Case No.:88/16/82-

ALC4/2015 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 167

Case No.:53/16/82-

ALC4/2015 Party Name:LAXMI ORGANIC INDUSTRIES LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01373/AM16/ RLA File :03/95/040/00540/AM16/ Lic.No/Date:0310800090 06.11.2015 Defer Date:08.03.2017 Decision :Deferred. 168

Case No.:89/16/82-

ALC4/2015 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01409/AM16/ RLA File :34/24/040/00203/AM16/ Lic.No/Date:3410041666 09.11.2015 Defer Date:08.03.2017 Decision :Deferred. 169 Case No.:73/17/82-ALC4/2016 Party Name:GLOBAL Meet No/Date:17/82- Status:

30 CALCIUM PRIVATE LIMITED, ALC4/2016 24.01.2017 Approved HQ File :01/82/050/01034/AM17/ RLA File :07/24/040/00265/AM16/ Lic.No/Date:0710109042 13.11.2015 Defer Date: taken by NC in its meeting No.08/82 dated 25.09.2014, uploaded at the end of these minutes or 170

Case No.:114/17/82-

ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01075/AM17/ RLA File :07/24/040/00255/AM16/ Lic.No/Date:0710109043 13.11.2015 Defer Date: Decision :Deferred. 171

Case No.:114/16/82-

ALC4/2015 Party Name:SHIVA BIOCHEM INDUSTRIES Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01434/AM16/ RLA File :50/24/040/00017/AM16/ Lic.No/Date:5010002240 16.11.2015 Defer Date:08.03.2017 Decision :Deferred. 172

Case No.:4/20/82-ALC4/2015 Party Name:AIMS IMPEX

PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01587/AM16/ RLA File :03/94/040/00656/AM16/ Lic.No/Date:0310800363 23.11.2015 Defer Date:08.03.2017 Decision :Deferred. 173

Case No.:31/1/82-ALC1/2016 Party Name:PAYAL

PETROCHEM PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01805/AM16/ RLA File :05/24/040/00347/AM16/ Lic.No/Date:0510396399 23.11.2015 Defer Date:08.03.2017 Decision :Deferred. 174

Case No.:2/20/82-ALC4/2015 Party Name:PCL OIL &

SOLVENTS LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 175

Case No.:33/1/82-ALC1/2016 Party Name:INCHEM

LABORATORIES PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File RLA File Lic.No/Date:0910062902 Defer

31 :01/82/050/01807/AM16/ :09/24/040/00486/AM16/ 26.11.2015 Date:08.03.2017 Decision :The Committee noted that information called for from the firm in NC meeting No.07 dated 07.07.2016 is awaited. The Committee accordingly deferred the case. 176

Case No.:32/16/82-

ALC4/2015 Party Name:INTERMED, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01352/AM16/ RLA File :04/24/040/00177/AM16/ Lic.No/Date:0410161343 26.11.2015 Defer Date:08.03.2017 Decision :Deferred. 177

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

Party Name:UNIJULES LIFE SCIENCES LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01776/AM16/ RLA File :03/95/040/00632/AM16/ Lic.No/Date:0310800416 26.11.2015 Defer Date:08.03.2017 Decision :Deferred. 178

Case No.:58/20/82-

ALC4/2015 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01641/AM16/ RLA File :03/95/040/00182/AM15/ Lic.No/Date:0310800550 01.12.2015 Defer Date:08.03.2017 Decision :Deferred. 179

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

Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01777/AM16/ RLA File :03/95/040/00529/AM15/ Lic.No/Date:0310800547 01.12.2015 Defer Date:08.03.2017 Decision :Deferred. 180

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

Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01779/AM16/ RLA File :03/95/040/00239/AM15/ Lic.No/Date:0310800551 01.12.2015 Defer Date:08.03.2017 Decision :Deferred. 181

Case No.:54/20/82-

ALC4/2015 Party Name:MELOG SPECIALITY CHEMICALS PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 182 Case No.:112/20/82- Party Name:SUPREET Meet No/Date:17/82- Status:

32 ALC4/2015 CHEMICALS PVT.LTD. ALC4/2016 24.01.2017 Deferred HQ File :01/82/050/01695/AM16/ RLA File :03/95/040/00646/AM16/ Lic.No/Date:0310800620 03.12.2015 Defer Date:08.03.2017 Decision :Deferred. 183

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

DYE-CHEM PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01670/AM16/ RLA File :03/95/040/00605/AM16/ Lic.No/Date:0310800715 07.12.2015 Defer Date: 184

Case No.:35/20/82-ALC4/2015 Party Name:BENZO CHEM

INDUSTRIES PRIVATE LIMITED, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01618/AM16/ RLA File :03/94/040/00480/AM16/ Lic.No/Date:0310800769 08.12.2015 Defer Date: Decision : The Committee decided to ratify norms based on the earlier recommendation of D/o C&PC forwarded vide U.O.No.14010/29/2011-Ch-II dated 20.10.2015, 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. 185

Case No.:127/16/82-

ALC4/2015 Party Name:BLUELINE FOODS (INDIA) PVT.LTD, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01447/AM16/ RLA File :07/24/040/00267/AM16/ Lic.No/Date:0710109146 08.12.2015 Defer Date:08.03.2017 Decision :Deferred. 186

Case No.:36/20/82-

ALC4/2015 Party Name:BAYER VAPI PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01619/AM16/ RLA File :03/94/040/00651/AM16/ Lic.No/Date:0310800833 09.12.2015 Defer Date:08.03.2017 Decision :Deferred. 187

Case No.:110/20/82-

ALC4/2015 Party Name:PROCESS AGROCHEM INDUSTRIES PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01693/AM16/ RLA File :56/24/040/00040/AM16/ Lic.No/Date:5610004767 10.12.2015 Defer Date:08.03.2017 Decision :Deferred. 188 Case No.:66/20/82- ALC4/2015 Party Name:PRIVI ORGANICS LTD Meet No/Date:17/82- ALC4/2016 Status: Deferred

33 24.01.2017 HQ File :01/82/050/01649/AM16/ RLA File :03/95/040/00633/AM16/ Lic.No/Date:0310800935 11.12.2015 Defer Date:08.03.2017 Decision :Deferred. 189

Case No.:45/20/82-

ALC4/2015 Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 190

Case No.:24/20/82-

ALC4/2015 Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01607/AM16/ RLA File :03/95/040/00088/AM16/ Lic.No/Date:0310800991 14.12.2015 Defer Date:08.03.2017 Decision :Deferred 191

Case No.:46/20/82-

ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 192

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

DYE-CHEM PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01606/AM16/ RLA File :03/95/040/00697/AM16/ Lic.No/Date:0310801116 16.12.2015 Defer Date: taken by NC in its meeting No.39/82 dated 27.12.2011, uploaded at the end of these minutes or 193

Case No.:8/20/82-ALC4/2015 Party Name:SHREE

BANKEY BEHARI LAL BOARD MILLS Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 194

Case No.:83/1/82-ALC1/2016 Party Name:JINDAL DRUGS

PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File RLA File Lic.No/Date:0310801211 Defer

34 :01/82/050/01857/AM16/ :03/94/040/00752/AM16/ 18.12.2015 Date:08.03.2017 Decision :Deferred. 195

Case No.:14/20/82-

ALC4/2015 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01597/AM16/ RLA File :03/94/040/00728/AM16/ Lic.No/Date:0310801252 21.12.2015 Defer Date:08.03.2017 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/866/2015-PI(Norms) dated 18.05.2016, uploaded at the end of these minutes and deferred the case. 196

Case No.:19/20/82-

ALC4/2015 Party Name:LAXMI ORGANIC INDUSTRIES LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01602/AM16/ RLA File :03/95/040/00009/AM16/ Lic.No/Date:0310801275 22.12.2015 Defer Date:08.03.2017 Decision :Deferred. 197

Case No.:20/20/82-

ALC4/2015 Party Name:LAXMI ORGANIC INDUSTRIES LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01603/AM16/ RLA File :03/95/040/00267/AM16/ Lic.No/Date:0310801273 22.12.2015 Defer Date:08.03.2017 Decision :Deferred. 198

Case No.:48/20/82-

ALC4/2015 Party Name:ALCHEMIE LABORATORIES Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01631/AM16/ RLA File :03/94/040/00683/AM16/ Lic.No/Date:0310801362 28.12.2015 Defer Date:08.03.2017 Decision :Deferred. 199

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

CORPORATION OF INDIA Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01605/AM16/ RLA File :03/95/040/00738/AM16/ Lic.No/Date:0310801409 30.12.2015 Defer Date: taken by NC in its meeting No.17/82 dated 05.12.2013, uploaded at the end of these minutes or 200

Case No.:47/20/82-

ALC4/2015 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01630/AM16/ RLA File :03/94/040/00792/AM16/ Lic.No/Date:0310801428 31.12.2015 Defer Date:08.03.2017

35 Decision :Deferred. 201

Case No.:98/20/82-

ALC4/2015 KABI ONCOLOGY LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01681/AM16/ RLA File :05/23/040/00338/AM16/ Lic.No/Date:0510397164 31.12.2015 Defer Date:08.03.2017 Decision :Deferred. 202

Case No.:99/20/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 203

Case No.:101/20/82-

ALC4/2015 Party Name:SONGWON SPECIALTY CHEMICALS INDIA PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01684/AM16/ RLA File :34/24/040/00226/AM16/ Lic.No/Date:3410041775 31.12.2015 Defer Date:08.03.2017 Decision :Deferred. 204

Case No.:119/20/82-

ALC4/2015 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01702/AM16/ RLA File :09/24/040/00582/AM16/ Lic.No/Date:0910063066 31.12.2015 Defer Date:08.03.2017 Decision :Deferred. 205

Case No.:104/20/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01687/AM16/ RLA File :34/24/040/00253/AM16/ Lic.No/Date:3410041778 04.01.2016 Defer Date:08.03.2017 Decision :Deferred. 206

Case No.:105/20/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01688/AM16/ RLA File :34/24/040/00252/AM16/ Lic.No/Date:3410041782 05.01.2016 Defer Date:08.03.2017 Decision :Deferred. 207

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

LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved

36 HQ File :01/82/050/01661/AM16/ RLA File :03/95/040/00652/AM16/ Lic.No/Date:0310801554 05.01.2016 Defer Date: taken by NC in its meeting No.4/82 dated 16.05.2013, uploaded at the end of these minutes or as 208

Case No.:26/20/82-

ALC4/2015 Party Name:AMINES & Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01609/AM16/ RLA File :03/94/040/00802/AM16/ Lic.No/Date:0310801601 06.01.2016 Defer Date:08.03.2017 Decision :Deferred. 209

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

Party Name:PRIVI ORGANICS LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01781/AM16/ RLA File :03/95/040/00688/AM16/ Lic.No/Date:0310801600 06.01.2016 Defer Date:08.03.2017 Decision :Deferred. 210

Case No.:76/20/82-

ALC4/2015 Party Name:AIMS IMPEX PVT. LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01659/AM16/ RLA File :03/94/040/00790/AM16/ Lic.No/Date:0310801644 07.01.2016 Defer Date:08.03.2017 Decision :Deferred. 211

Case No.:103/20/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 212

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

Party Name:MEDISPRAY LABORATORIES PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01780/AM16/ RLA File :03/95/040/00676/AM16/ Lic.No/Date:0310801634 07.01.2016 Defer Date:08.03.2017 Decision : Information called for from the firm in NC meeting No.11/AM17 dated 07.09.2016 is awaited. The committee accordingly deferred the case. 213

Case No.:32/1/82-ALC1/2016 Party Name:PAYAL

PETROCHEM PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017

37 Decision :Deferred. 214

Case No.:95/20/82-

ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01678/AM16/ RLA File :05/24/040/00499/AM16/ Lic.No/Date:0510397256 08.01.2016 Defer Date:08.03.2017 Decision : Information called for from the firm in NC meeting No.07/AM17 dated 07.07.2016 is awaited. The committee accordingly deferred the case. 215

Case No.:21/20/82-

ALC4/2015 Party Name:SHREE LIFE SCIENCES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01604/AM16/ RLA File :03/95/040/00762/AM16/ Lic.No/Date:0310801691 11.01.2016 Defer Date:08.03.2017 Decision :Deferred. 216

Case No.:48/1/82-ALC1/2016 Party Name:INDO AMINES

LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01822/AM16/ RLA File :03/94/040/00785/AM16/ Lic.No/Date:0310801728 12.01.2016 Defer Date:08.03.2017 217

Case No.:82/1/82-ALC1/2016 Party Name:PRIVI

ORGANICS LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01856/AM16/ RLA File :03/95/040/00690/AM16/ Lic.No/Date:0310801719 12.01.2016 Defer Date:08.03.2017 218

Case No.:66/1/82-ALC1/2016 Party Name:BTL EXPORTS

PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01840/AM16/ RLA File :03/94/040/00831/AM16/ Lic.No/Date:0310801850 18.01.2016 Defer Date:08.03.2017 219

Case No.:79/1/82-ALC1/2016 Party Name:PRIVI

ORGANICS LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01853/AM16/ RLA File :03/95/040/00689/AM16/ Lic.No/Date:0310801831 18.01.2016 Defer Date:08.03.2017 Decision :Deferred. 220

Case No.:59/1/82-ALC1/2016 Party Name:GLOBE

TROTTERS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred

38 HQ File :01/82/050/01833/AM16/ RLA File :03/94/040/00589/AM16/ Lic.No/Date:0310801896 19.01.2016 Defer Date:08.03.2017 Decision :Deferred. 221

Case No.:114/20/82-

ALC4/2015 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01697/AM16/ RLA File :34/24/040/00263/AM16/ Lic.No/Date:3410041814 19.01.2016 Defer Date:08.03.2017 Decision :Deferred 222

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

Party Name:MEDISPRAY LABORATORIES PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01851/AM16/ RLA File :03/95/040/00657/AM16/ Lic.No/Date:0310801888 19.01.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/442/2011-PI(Norms) dated 22.02.2012, uploaded 223

Case No.:50/1/82-ALC1/2016 Party Name:AMINES &

Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01824/AM16/ RLA File :03/94/040/00861/AM16/ Lic.No/Date:0310801928 20.01.2016 Defer Date:08.03.2017 224

Case No.:68/1/82-ALC1/2016 Party Name:BTL EXPORTS

PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 225

Case No.:106/20/82-

ALC4/2015 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01689/AM16/ RLA File :05/24/040/00515/AM16/ Lic.No/Date:0510397367 20.01.2016 Defer Date:08.03.2017 Decision : Information called from the firm in NC meeting No.05/82 dated 08.06.2016 is awaited. The Committee accordingly deferred the case. 226

Case No.:38/1/82-ALC1/2016 Party Name:SURVIVAL

Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01812/AM16/ RLA File :03/95/040/00798/AM16/ Lic.No/Date:0310801923 20.01.2016 Defer Date:08.03.2017

39 227

Case No.:49/1/82-ALC1/2016 Party Name:AMINES &

Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01823/AM16/ RLA File :03/94/040/00869/AM16/ Lic.No/Date:0310801950 21.01.2016 Defer Date:08.03.2017 228

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

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01798/AM16/ RLA File :04/24/040/00210/AM16/ Lic.No/Date:0410161548 22.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/872/2016-PI(Norms) dated 24.05.2016, uploaded 229

Case No.:72/7/82-ALC4/2016 Party Name:OGENE

SYSTEMS INDIA LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00246/AM17/ RLA File :09/24/040/00620/AM16/ Lic.No/Date:0910063151 22.01.2016 Defer Date:08.03.2017 230

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

CHEMICAL INDUSTRIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01679/AM16/ RLA File :02/24/040/00178/AM16/ Lic.No/Date:0210206458 22.01.2016 Defer Date: taken by NC in its meeting No.39/82 dated 28.12.2010, uploaded at the end of these minutes or 231

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

Party Name:INDO AMINES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01826/AM16/ RLA File :03/94/040/00888/AM16/ Lic.No/Date:0310802024 25.01.2016 Defer Date: taken by NC in its meeting No.4/82 dated 24.04.2012, uploaded at the end of these minutes or as 232 Case No.:88/7/82-ALC4/2016 Party Name:SALICYLATES & CHEMICALS PRIVATE Meet No/Date:17/82- ALC4/2016 Status: Deferred

40 LIMITED 24.01.2017 HQ File :01/82/050/00262/AM17/ RLA File :09/24/040/00304/AM16/ Lic.No/Date:0910063190 29.01.2016 Defer Date:08.03.2017 233

Case No.:27/1/82-ALC1/2016 Party Name:BODAL

CHEMICALS LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01801/AM16/ RLA File :08/24/040/00325/AM16/ Lic.No/Date:0810137105 01.02.2016 Defer Date:08.03.2017 234

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

Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01818/AM16/ RLA File :03/94/040/00886/AM16/ Lic.No/Date:0310802172 02.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/84/2014-PI(Norms) dated Oct.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP 235

Case No.:40/1/82-ALC1/2016 Party Name:MAGNOLIA

LIMITED. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01814/AM16/ RLA File :03/95/040/01074/AM15/ Lic.No/Date:0310802175 02.02.2016 Defer Date:08.03.2017 236

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

Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 237

Case No.:37/1/82-ALC1/2016 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01811/AM16/ RLA File :03/95/040/00639/AM16/ Lic.No/Date:0310802231 04.02.2016 Defer Date:08.03.2017 238

Case No.:43/1/82-ALC1/2016 Party Name:AARTI

INDUSTRIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01817/AM16/ RLA File :03/94/040/00882/AM16/ Lic.No/Date:0310802261 05.02.2016 Defer Date:08.03.2017

41 239

Case No.:58/1/82-ALC1/2016 Party Name:SURVIVAL

Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01832/AM16/ RLA File :03/95/040/00819/AM16/ Lic.No/Date:0310802266 05.02.2016 Defer Date:08.03.2017 240

Case No.:69/1/82-ALC1/2016 Party Name:ENCUBE

ETHICALS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01843/AM16/ RLA File :03/94/040/00922/AM16/ Lic.No/Date:0310802291 08.02.2016 Defer Date:08.03.2017 241

Case No.:74/1/82-ALC1/2016 Party Name:HUBERGROUP

INDIA PRIVATE LIMITED. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01848/AM16/ RLA File :03/94/040/00810/AM16/ Lic.No/Date:0310802333 08.02.2016 Defer Date:08.03.2017 242

Case No.:39/1/82-ALC1/2016 Party Name:PERFECT

VITAMINS PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01813/AM16/ RLA File :03/95/040/00847/AM16/ Lic.No/Date:0310802292 08.02.2016 Defer Date:08.03.2017 243

Case No.:45/1/82-ALC1/2016 Party Name:KAIRAV

CHEMOFARBE INDUSTRIES LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01819/AM16/ RLA File :03/94/040/00859/AM16/ Lic.No/Date:0310802380 09.02.2016 Defer Date:08.03.2017 244

Case No.:79/7/82-ALC4/2016 Party Name:OPTIMUS

DRUGS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00253/AM17/ RLA File :09/24/040/00586/AM16/ Lic.No/Date:0910063240 10.02.2016 Defer Date:08.03.2017 Decision : : Information called for from the firm in NC meeting No.09/82 dated 10.08.2016 is awaited. The committee accordingly deferred the case. 245

Case No.:41/1/82-ALC1/2016 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred

42 HQ File :01/82/050/01815/AM16/ RLA File :03/95/040/00826/AM16/ Lic.No/Date:0310802395 10.02.2016 Defer Date:08.03.2017 Decision :Deferred. 246

Case No.:78/1/82-ALC1/2016 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01852/AM16/ RLA File :03/95/040/00752/AM16/ Lic.No/Date:0310802451 10.02.2016 Defer Date:08.03.2017 247

Case No.:26/1/82-ALC1/2016 Party Name:UMA

ENTERPRISE Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01800/AM16/ RLA File :08/24/040/00396/AM16/ Lic.No/Date:0810137202 15.02.2016 Defer Date:08.03.2017 248

Case No.:56/1/82-ALC1/2016 Party Name:ZIM

LABORATORIES LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01830/AM16/ RLA File :03/95/040/00887/AM16/ Lic.No/Date:0310802649 16.02.2016 Defer Date:08.03.2017 Decision : Information called for from the firm in NC meeting No.13/82 dated 16.11.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 249

Case No.:17/1/82-ALC1/2016 Party Name:ARJUN

CHEMICALS PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01791/AM16/ RLA File :04/24/040/00229/AM16/ Lic.No/Date:0410161613 17.02.2016 Defer Date:08.03.2017 Decision :Deferred. 250

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

Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01831/AM16/ RLA File :03/95/040/00895/AM16/ Lic.No/Date:0310802676 17.02.2016 Defer Date: its meeting No.10/82 dated 22.08.2013 for same export product , uploaded at the end of these 251

Case No.:78/7/82-ALC4/2016 Party Name:VIVIMED LABS

LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017

43 Decision :Deferred. 252

Case No.:32/4/82-ALC4/2016

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00095/AM17/ RLA File :03/94/040/00961/AM16/ Lic.No/Date:0310802807 23.02.2016 Defer Date: taken by NC in its meeting No.4/82 dated 26.04.2011, uploaded at the end of these minutes or as 253

Case No.:115/17/82-

ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01076/AM17/ RLA File :07/24/040/00386/AM16/ Lic.No/Date:0710109429 23.02.2016 Defer Date: taken by NC in its meeting No.40/82 dated 04.01.2011, uploaded at the end of these minutes or 254

Case No.:12/7/82-ALC4/2016 Party Name:MEDICLONE

BIO-TECH PRIVATE LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred for DBT. 255

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

DRUGS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00256/AM17/ RLA File :09/24/040/00721/AM16/ Lic.No/Date:0910063357 03.03.2016 Defer Date:08.03.2017 Decision :Deferred. 256

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

INDUSTRIES LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00233/AM17/ RLA File :56/24/040/00054/AM16/ Lic.No/Date:5610004864 11.03.2016 Defer Date:08.03.2017 Decision :Deferred. 257

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

CHEMICALS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00024/AM17/ RLA File :03/95/040/00955/AM16/ Lic.No/Date:0310803229 11.03.2016 Defer Date:08.03.2017

44 Decision :Deferred. 258

Case No.:100/7/82-

ALC4/2016 Party Name:CATAPHARMA CHEMICALS PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00274/AM17/ RLA File :31/83/040/00174/AM16/ Lic.No/Date:3110066051 14.03.2016 Defer Date:08.03.2017 Decision :Deferred. 259

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

Party Name:SUNSHIELD CHEMICALS LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00145/AM17/ RLA File :03/95/040/00967/AM16/ Lic.No/Date:0310803283 14.03.2016 Defer Date: Decision : Approved in meeting No.10/82 dated 23.08.2016. 260

Case No.:15/1/82-ALC1/2016 Party Name:COVALENT

LABORATORIES PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01789/AM16/ RLA File :09/24/040/00713/AM16/ Lic.No/Date:0910063416 15.03.2016 Defer Date:08.03.2017 Decision :Deferred. 261

Case No.:107/7/82-

ALC4/2016 Party Name:ASTRAL STERITECH PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 262

Case No.:109/7/82-

ALC4/2016 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00283/AM17/ RLA File :34/24/040/00336/AM16/ Lic.No/Date:3410041989 21.03.2016 Defer Date:08.03.2017 Decision :Deferred. 263

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

PHARMACHEM LTD, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00285/AM17/ RLA File :34/24/040/00346/AM16/ Lic.No/Date:3410041992 21.03.2016 Defer Date: taken by NC in its meeting No.25/82 dated 29.11.2012, uploaded at the end of these minutes or 264 Case No.:48/4/82-ALC4/2016 Party Name:AVA Meet No/Date:17/82- Status:

45 CHEMICALS PVT.LTD., ALC4/2016 24.01.2017 Approved HQ File :01/82/050/00111/AM17/ RLA File :03/94/040/01067/AM16/ Lic.No/Date:0310803525 23.03.2016 Defer Date: taken by NC in its meeting No.26/82 dated 13.12.2012, uploaded at the end of these minutes or 265

Case No.:39/7/82-ALC4/2016 Party Name:POSY

PHARMACHEM PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/609/2014-PI(Norms) dated April 2015, uploaded at the end of these minutes and deferred the case. 266

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

Party Name:VENUS REMEDIES LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00232/AM17/ RLA File :22/24/040/00133/AM16/ Lic.No/Date:2210015463 31.03.2016 Defer Date: Decision : The Committee decided to ratify norms based on SION A-3667 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. 267

Case No.:138/7/82-

ALC4/2016 Party Name:ALTA LABORATORIES LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00312/AM17/ RLA File :03/94/040/01112/AM16/ Lic.No/Date:0310803707 01.04.2016 Defer Date:08.03.2017 Decision :Deferred. 268

Case No.:81/11/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 269

Case No.:104/7/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred.

46 270

Case No.:24/7/82-ALC4/2016 Party Name:DEEPAK

NOVOCHEM TECHNOLOGIES LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00198/AM17/ RLA File :31/83/040/00186/AM16/ Lic.No/Date:3110066111 05.04.2016 Defer Date:08.03.2017 Decision :Deferred. 271

Case No.:38/7/82-ALC4/2016 Party Name:JODAS EXPOIM

PVT.LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 272

Case No.:123/7/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 273

Case No.:42/7/82-ALC4/2016 Party Name:ALEMBIC

PHARMACEUTICALS LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision : The Committee decided to call for information as per recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/417/2014-PI (Norms) dated 22.01.2015, uploaded as the end of these minutes and deferred the case. 274

Case No.:52/7/82-ALC4/2016 Party Name:FINE CURE

PHARMACEUTICALS LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00226/AM17/ RLA File :08/24/040/00460/AM16/ Lic.No/Date:0810137652 11.04.2016 Defer Date:08.03.2017 Decision :Deferred. 275

Case No.:45/7/82-ALC4/2016 Party Name:ASTRAL

STERITECH PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00219/AM17/ RLA File :34/24/040/00009/AM17/ Lic.No/Date:3410042064 13.04.2016 Defer Date:08.03.2017 Decision :Deferred. 276

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

PLASTICIZERS LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File RLA File Lic.No/Date:0510398217 Defer Date:

47 :01/82/050/00621/AM17/ :05/23/040/00554/AM16/ 13.04.2016 taken by NC in its meeting No.03/82 dated 20.04.2010, uploaded at the end of these minutes or 277

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

CHEMICALS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00224/AM17/ RLA File :08/24/040/00005/AM17/ Lic.No/Date:0810137692 18.04.2016 Defer Date:08.03.2017 Decision :Deferred. 278

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

Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: approved HQ File :01/82/050/00207/AM17/ RLA File :05/23/040/00018/AM17/ Lic.No/Date:0510398279 22.04.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/665/2012-PI(Norms) dated 06.02.2013, uploaded 279

Case No.:15/7/82-ALC4/2016 Party Name:SUPREET

CHEMICALS PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00189/AM17/ RLA File :52/24/040/00006/AM17/ Lic.No/Date:5210041869 25.04.2016 Defer Date:08.03.2017 Decision :Deferred. 280

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

CHEMICALS PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00318/AM17/ RLA File :03/94/040/01042/AM16/ Lic.No/Date:0310804172 26.04.2016 Defer Date: taken by NC in its meeting No.14/82 dated 05.07.2011, uploaded at the end of these minutes or 281

Case No.:148/7/82-

ALC4/2016 Party Name:HEMA DYE CHEM PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00322/AM17/ RLA File :03/94/040/00055/AM17/ Lic.No/Date:0310804211 26.04.2016 Defer Date:08.03.2017 Decision :Deferred. 282 Case No.:2/17/82-ALC4/2016 Party Name:LUPIN LIMITED Meet No/Date:17/82- ALC4/2016 Status: Deferred

48 24.01.2017 HQ File :01/82/050/00963/AM17/ RLA File :03/95/040/00002/AM17/ Lic.No/Date:0310804193 26.04.2016 Defer Date: 08.03.2017 Decision :Deferred. 283

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

EXIMCHEM PRIVATE LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00301/AM17/ RLA File :03/95/040/00048/AM17/ Lic.No/Date:0310804183 26.04.2016 Defer Date: its meeting No.08/82 dated 11.07.2013 for same export product , uploaded at the end of these 284

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

EXIMCHEM PRIVATE LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00302/AM17/ RLA File :03/95/040/00049/AM17/ Lic.No/Date:0310804184 26.04.2016 Defer Date: its meeting No.33/82 dated 21.03.2013 for same export product , uploaded at the end of these 285

Case No.:32/7/82-ALC4/2016 Party Name:HELLO PAINTS

(P) LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 286

Case No.:146/7/82-

ALC4/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00320/AM17/ RLA File :03/94/040/00012/AM17/ Lic.No/Date:0310804283 29.04.2016 Defer Date:08.03.2017 Decision :Deferred. 287

Case No.:142/7/82-

ALC4/2016 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00316/AM17/ RLA File :03/94/040/01101/AM16/ Lic.No/Date:0310804342 02.05.2016 Defer Date:08.03.2017 Decision : Information called for from the in NC meeting No.11/82 dated 07.09.2016 is awaited. The Committee accordingly deferred the case.

49 288

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

DYE-CHEM PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00303/AM17/ RLA File :03/95/040/00004/AM17/ Lic.No/Date:0310804339 02.05.2016 Defer Date: 289

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

Party Name:ALKALOIDS CORPORATION Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: approved HQ File :01/82/050/00249/AM17/ RLA File :02/24/040/00016/AM17/ Lic.No/Date:0210206661 04.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/437/2015-PI(Norms) dated August 2016, 290

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

Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00540/AM17/ RLA File :09/24/040/00052/AM17/ Lic.No/Date:0910063584 05.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/138/2016-PI(Norms) dated August 2016, 291

Case No.:49/7/82-ALC4/2016 Party Name:PANACEA

BIOTEC LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00223/AM17/ RLA File :05/24/040/00009/AM17/ Lic.No/Date:0510398392 05.05.2016 Defer Date:08.03.2017 Decision :Deferred for DBT. 292

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

Party Name:STRIDES SHASUN LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00182/AM17/ RLA File :04/24/040/00009/AM17/ Lic.No/Date:0410161871 05.05.2016 Defer Date:08.03.2017 Decision : Information called for from the in NC meeting No.11/82 dated 07.09.2016 is awaited. The Committee accordingly deferred the case. 293

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

Party Name:STRIDES SHASUN LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00183/AM17/ RLA File :04/24/040/00010/AM17/ Lic.No/Date:0410161872 05.05.2016 Defer Date:08.03.2017

50 Decision : Information called for from the in NC meeting No.11/82 dated 07.09.2016 is awaited. The Committee accordingly deferred the case. 294

Case No.:163/7/82-

ALC4/2016 Party Name:AMINES & Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00337/AM17/ RLA File :03/94/040/00090/AM17/ Lic.No/Date:0310804480 09.05.2016 Defer Date:08.03.2017 Decision :Deferred. 295

Case No.:17/7/82-ALC4/2016 Party Name:CONTINENTAL

CHEMICALS Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 Decision :Deferred. 296

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

CHEMICALS Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00192/AM17/ RLA File :08/24/040/00044/AM17/ Lic.No/Date:0810137877 09.05.2016 Defer Date:08.03.2017 Decision :Deferred. 297

Case No.:51/7/82-ALC4/2016 Party Name:JUBILANT LIFE

SCIENCES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00225/AM17/ RLA File :05/23/040/00539/AM16/ Lic.No/Date:0510398432 09.05.2016 Defer Date:08.03.2017 Decision :Deferred. 298

Case No.:159/7/82-

ALC4/2016 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00333/AM17/ RLA File :03/94/040/00061/AM17/ Lic.No/Date:0310804534 10.05.2016 Defer Date:08.03.2017 Decision :Deferred. 299

Case No.:160/7/82-

ALC4/2016 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00334/AM17/ RLA File :03/94/040/00036/AM17/ Lic.No/Date:0310804533 10.05.2016 Defer Date:08.03.2017 Decision :Deferred. 300 Case No.:76/7/82-ALC4/2016 Party Name:FRESENIUS KABI ONCOLOGY Meet No/Date:17/82- ALC4/2016 Status: Deferred

51 LIMITED 24.01.2017 HQ File :01/82/050/00250/AM17/ RLA File :05/23/040/00031/AM17/ Lic.No/Date:0510398443 10.05.2016 Defer Date:08.03.2017 Decision : Information called for from the in NC meeting No.09/82 dated 10.08.2016 is awaited. The Committee accordingly deferred the case. 301

Case No.:137/7/82-

ALC4/2016 Party Name:RELIANCE INDUSTRIES LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00311/AM17/ RLA File :03/95/040/00763/AM16/ Lic.No/Date:0310804513 10.05.2016 Defer Date:08.03.2017 Decision :Deferred. 302

Case No.:157/7/82-

ALC4/2016 Party Name:APEX PHARMA, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00331/AM17/ RLA File :03/94/040/00122/AM17/ Lic.No/Date:0310804628 12.05.2016 Defer Date:08.03.2017 303

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

Party Name:KLJ Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00248/AM17/ RLA File :05/23/040/00050/AM17/ Lic.No/Date:0510398481 12.05.2016 Defer Date: taken by NC in its meeting No.20/82 dated 16.08.2011, uploaded at the end of these minutes or 304

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

DYE-CHEM PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00305/AM17/ RLA File :03/95/040/00016/AM17/ Lic.No/Date:0310804666 13.05.2016 Defer Date: taken by NC in its meeting No.39/82 dated 27.12.2011, uploaded at the end of these minutes or 305

Case No.:86/11/82-

ALC4/2016 Party Name:ALMELO PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00620/AM17/ RLA File :09/24/040/00056/AM17/ Lic.No/Date:0910063626 17.05.2016 Defer Date:08.03.2017 306 Case No.:85/11/82- Party Name:COVALENT Meet No/Date:17/82- Status:

52 ALC4/2016 LABORATORIES PRIVATE LIMITED ALC4/2016 24.01.2017 Deferred HQ File :01/82/050/00619/AM17/ RLA File :09/24/040/00028/AM17/ Lic.No/Date:0910063644 17.05.2016 Defer Date:08.03.2017 307

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

CALCIUM PRIVATE LIMITED, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01032/AM17/ RLA File :07/24/040/00385/AM16/ Lic.No/Date:0710109823 17.05.2016 Defer Date: 08.03.2017 308

Case No.:82/11/82-

ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00616/AM17/ RLA File :05/24/040/00624/AM16/ Lic.No/Date:0510398507 17.05.2016 Defer Date:08.03.2017 309

Case No.:83/11/82-

ALC4/2016 Party Name:BIOLOGICAL E LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00617/AM17/ RLA File :09/24/040/00307/AM15/ Lic.No/Date:0910063658 19.05.2016 Defer Date:08.03.2017 Decision : Deferred for DBT. 310

Case No.:132/7/82-

ALC4/2016 Party Name:SURVIVAL Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00306/AM17/ RLA File :03/95/040/00118/AM17/ Lic.No/Date:0310804885 20.05.2016 Defer Date:08.03.2017 311

Case No.:139/7/82-

ALC4/2016 Party Name:GANGWAL CHEMICALS (P) LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00313/AM17/ RLA File :03/94/040/00149/AM17/ Lic.No/Date:0310804914 23.05.2016 Defer Date:08.03.2017 312

Case No.:140/7/82-

ALC4/2016 Party Name:GANGWAL CHEMICALS (P) LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00314/AM17/ RLA File :03/94/040/00148/AM17/ Lic.No/Date:0310804913 23.05.2016 Defer Date:08.03.2017

53 313

Case No.:153/7/82-

ALC4/2016 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00327/AM17/ RLA File :03/94/040/00115/AM17/ Lic.No/Date:0310804948 24.05.2016 Defer Date:08.03.2017 314

Case No.:134/7/82-

ALC4/2016 Party Name:ORBIT LIFE SCIENCE PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00308/AM17/ RLA File :03/95/040/00069/AM17/ Lic.No/Date:0310804944 24.05.2016 Defer Date:08.03.2017 Decision : The Committee decided to call for information as per recommendation of D/o Pharmaceutical vide O.M.No.35011/145/2016-PI(norms) dated July 2016, uploaded at the end of these minutes and deferred the case. 315

Case No.:6/17/82-ALC4/2016

Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00967/AM17/ RLA File :05/24/040/00064/AM17/ Lic.No/Date:0510398690 31.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/62/2015-PI(Norms) dated Oct. 2015, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP 316

Case No.:43/10/82-

ALC4/2016 Party Name:O C SPECIALITIES PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00389/AM17/ RLA File :03/95/040/00169/AM17/ Lic.No/Date:0310805124 01.06.2016 Defer Date:08.03.2017 317

Case No.:2/11/82-ALC4/2016 Party Name:MANALI

PETROCHEMICALS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00536/AM17/ RLA File :04/24/040/00270/AM16/ Lic.No/Date:0410162005 02.06.2016 Defer Date:08.03.2017 318

Case No.:1/11/82-ALC4/2016 Party Name:JODAS EXPOIM

PVT.LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017

54 319

Case No.:8/11/82-ALC4/2016 Party Name:SOFTGEL

HEALTH CARE PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00542/AM17/ RLA File :04/24/040/00042/AM17/ Lic.No/Date:0410162009 03.06.2016 Defer Date:08.03.2017 320

Case No.:61/11/82-

ALC4/2016 Party Name:KEKULE PHARMA LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 321

Case No.:29/13/82-

ALC4/2016 Party Name:KUTCH CHEMICAL INDUSTRIES LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00657/AM17/ RLA File :34/24/040/00068/AM17/ Lic.No/Date:3410042260 10.06.2016 Defer Date:08.03.2017 322

Case No.:62/11/82-

ALC4/2016 & CHEMICALS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00596/AM17/ RLA File :09/24/040/00077/AM17/ Lic.No/Date:0910063788 10.06.2016 Defer Date:08.03.2017 323

Case No.:64/11/82-

ALC4/2016 & CHEMICALS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00598/AM17/ RLA File :09/24/040/00076/AM17/ Lic.No/Date:0910063789 10.06.2016 Defer Date:08.03.2017 324

Case No.:89/13/82-

ALC4/2016 Party Name:UMA ENTERPRISE Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00717/AM17/ RLA File :08/24/040/00099/AM17/ Lic.No/Date:0810138154 10.06.2016 Defer Date:08.03.2017 325

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

Party Name:NEULAND LABORATORIES LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017

55 326

Case No.:5/11/82-ALC4/2016 Party Name:ASCENT

FINECHEM PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 327

Case No.:16/11/82-

ALC4/2016 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00550/AM17/ RLA File :03/95/040/00255/AM17/ Lic.No/Date:0310805798 29.06.2016 Defer Date:08.03.2017 328

Case No.:198/17/82-

ALC4/2016 Party Name:NASENSE LABS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01159/AM17/ RLA File :09/24/040/00172/AM17/ Lic.No/Date:0910063874 30.06.2016 Defer Date: 08.03.2017 329

Case No.:184/17/82-

ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01145/AM17/ RLA File :09/24/040/00143/AM17/ Lic.No/Date:0910063875 30.06.2016 Defer Date: 08.03.2017 330

Case No.:7/11/82-ALC4/2016 Party Name:PANERA

BIOTEC PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00541/AM17/ RLA File :05/24/040/00136/AM17/ Lic.No/Date:0510398951 30.06.2016 Defer Date:08.03.2017 Decision :Deferred from comments from DBT. 331

Case No.:185/17/82-

ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01146/AM17/ RLA File :09/24/040/00147/AM17/ Lic.No/Date:0910063885 04.07.2016 Defer Date: 08.03.2017 332

Case No.:14/11/82-

ALC4/2016 Party Name:PALADIN PAINTS AND CHEMICALS PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00548/AM17/ RLA File :03/95/040/00277/AM17/ Lic.No/Date:0310805923 04.07.2016 Defer Date:08.03.2017

56 333

Case No.:50/11/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00584/AM17/ RLA File :03/94/040/00275/AM17/ Lic.No/Date:0310805959 05.07.2016 Defer Date:08.03.2017 334

Case No.:53/11/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00587/AM17/ RLA File :03/94/040/00273/AM17/ Lic.No/Date:0310805958 05.07.2016 Defer Date:08.03.2017 335

Case No.:48/11/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00582/AM17/ RLA File :03/94/040/00255/AM17/ Lic.No/Date:0310805960 05.07.2016 Defer Date:08.03.2017 336

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

PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00631/AM17/ RLA File :05/24/040/00143/AM17/ Lic.No/Date:0510399022 06.07.2016 Defer Date:08.03.2017 337

Case No.:39/13/82-

ALC4/2016 Party Name:VIRDEV INTERMEDIATES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00667/AM17/ RLA File :52/24/040/00022/AM17/ Lic.No/Date:5210041951 08.07.2016 Defer Date:08.03.2017 338

Case No.:1/13/82-ALC4/2016 Party Name:FRESENIUS

KABI ONCOLOGY LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00629/AM17/ RLA File :05/23/040/00168/AM17/ Lic.No/Date:0510399049 11.07.2016 Defer Date:08.03.2017 339

Case No.:13/11/82-

ALC4/2016 Party Name:S M CHEMICAL VAPI PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred

57 HQ File :01/82/050/00547/AM17/ RLA File :03/95/040/00225/AM17/ Lic.No/Date:0310806063 11.07.2016 Defer Date:08.03.2017 taken by NC in its meeting No.16/82 dated 21.11.2013, uploaded at the end of these minutes or 340

Case No.:42/11/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00576/AM17/ RLA File :03/94/040/00198/AM17/ Lic.No/Date:0310806121 12.07.2016 Defer Date:08.03.2017 341

Case No.:43/11/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00577/AM17/ RLA File :03/94/040/00105/AM17/ Lic.No/Date:0310806120 12.07.2016 Defer Date:08.03.2017 342

Case No.:46/11/82-ALC4/2016 Party Name:ENCUBE

ETHICALS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00580/AM17/ RLA File :03/94/040/00276/AM17/ Lic.No/Date:0310806157 12.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/783/2015-PI(Norms) dated 22.08.2016, uploaded 343

Case No.:47/11/82-ALC4/2016 Party Name:ENCUBE

ETHICALS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00581/AM17/ RLA File :03/94/040/00274/AM17/ Lic.No/Date:0310806156 12.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/783/2015-PI(Norms) dated 22.08.2016, uploaded 344

Case No.:40/11/82-

ALC4/2016 Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00574/AM17/ RLA File :03/94/040/00237/AM17/ Lic.No/Date:0310806115 12.07.2016 Defer Date:08.03.2017 345 Case No.:52/11/82- Party Name:J.B. Meet No/Date:17/82- Status:

58 ALC4/2016 CHEMICALS & PHARMACEUTICALS LIMITED ALC4/2016 24.01.2017 Deferred HQ File :01/82/050/00586/AM17/ RLA File :03/94/040/00288/AM17/ Lic.No/Date:0310806113 12.07.2016 Defer Date:08.03.2017 346

Case No.:32/13/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00660/AM17/ RLA File :03/94/040/00291/AM17/ Lic.No/Date:0310806165 12.07.2016 Defer Date:08.03.2017 347

Case No.:89/11/82-

ALC4/2016 Party Name:MALWA OXYGEN & INDUSTRIAL GASES PVT.LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00623/AM17/ RLA File :56/24/040/00015/AM17/ Lic.No/Date:5610004949 12.07.2016 Defer Date:08.03.2017 348

Case No.:57/11/82-

ALC4/2016 Party Name:ZIM LABORATORIES LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00591/AM17/ RLA File :03/95/040/00296/AM17/ Lic.No/Date:0310806194 13.07.2016 Defer Date:08.03.2017 349

Case No.:68/11/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00602/AM17/ RLA File :08/24/040/00116/AM17/ Lic.No/Date:0810138288 14.07.2016 Defer Date:08.03.2017 350

Case No.:73/11/82-ALC4/2016 Party Name:DHANUKA

LABORATORIES LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00607/AM17/ RLA File :05/23/040/00192/AM17/ Lic.No/Date:0510399089 14.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/426/2015-PI(Norms) dated Oct. 2015, uploaded 351

Case No.:2/13/82-ALC4/2016

Party Name:JUBILANT GENERICS LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved

59 HQ File :01/82/050/00630/AM17/ RLA File :05/23/040/00194/AM17/ Lic.No/Date:0510399087 14.07.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION A-412 or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 352

Case No.:10/11/82-

ALC4/2016 Party Name:MATRIX FINE SCIENCES PVT.LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00544/AM17/ RLA File :03/95/040/00304/AM17/ Lic.No/Date:0310806238 14.07.2016 Defer Date:08.03.2017 353

Case No.:56/11/82-

ALC4/2016 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00590/AM17/ RLA File :03/95/040/00746/AM16/ Lic.No/Date:0310806245 14.07.2016 Defer Date:08.03.2017 354

Case No.:54/11/82-

ALC4/2016 Party Name:SWISS PARENTERALS PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 355

Case No.:72/11/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00606/AM17/ RLA File :08/24/040/00145/AM17/ Lic.No/Date:0810138301 15.07.2016 Defer Date:08.03.2017 356

Case No.:38/11/82-ALC4/2016 Party Name:GLOBE

TROTTERS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00572/AM17/ RLA File :03/94/040/00224/AM17/ Lic.No/Date:0310806304 15.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/521/2015-PI(Norms) dated 18.01.2016, uploaded 357

Case No.:37/11/82-ALC4/2016 Party Name:GLOBE

TROTTERS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File RLA File Lic.No/Date:0310806338 Defer Date:

60 :01/82/050/00571/AM17/ :03/94/040/00220/AM17/ 18.07.2016 Decision : The Committee decided to ratify norms based on SION A-3667 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. 358

Case No.:23/11/82-ALC4/2016 Party Name:ENCUBE

ETHICALS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: approved HQ File :01/82/050/00557/AM17/ RLA File :03/94/040/00301/AM17/ Lic.No/Date:0310806378 19.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/138/2011-PI(Norms) dated 04.01.2012, uploaded 359

Case No.:67/11/82-

ALC4/2016 KABI ONCOLOGY LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00601/AM17/ RLA File :05/23/040/00065/AM17/ Lic.No/Date:0510399129 19.07.2016 Defer Date:08.03.2017 360

Case No.:66/11/82-

ALC4/2016 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 361

Case No.:21/11/82-

ALC4/2016 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00555/AM17/ RLA File :03/95/040/00206/AM17/ Lic.No/Date:0310806373 19.07.2016 Defer Date:08.03.2017 362

Case No.:18/11/82-

ALC4/2016 Party Name:RESONANCE SPECIALTIES LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00552/AM17/ RLA File :03/95/040/00262/AM17/ Lic.No/Date:0310806401 19.07.2016 Defer Date:08.03.2017 363

Case No.:35/11/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00569/AM17/ RLA File :03/94/040/00283/AM17/ Lic.No/Date:0310806427 20.07.2016 Defer Date:08.03.2017

61 364

Case No.:74/11/82-

ALC4/2016 Party Name:KLJ Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00608/AM17/ RLA File :05/23/040/00195/AM17/ Lic.No/Date:0510399160 20.07.2016 Defer Date:08.03.2017 365

Case No.:19/11/82-

ALC4/2016 Party Name:REANNON PHARMACEUTICALS Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00553/AM17/ RLA File :03/95/040/00326/AM17/ Lic.No/Date:0310806484 21.07.2016 Defer Date:08.03.2017 366

Case No.:83/13/82-

ALC4/2016 Party Name:REANNON PHARMACEUTICALS Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00711/AM17/ RLA File :03/95/040/00327/AM17/ Lic.No/Date:0310806482 21.07.2016 Defer Date:08.03.2017 367

Case No.:25/11/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 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:08.03.2017 368

Case No.:26/11/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00560/AM17/ RLA File :03/95/040/00116/AM17/ Lic.No/Date:0310806480 21.07.2016 Defer Date:08.03.2017 369

Case No.:27/11/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00561/AM17/ RLA File :03/95/040/00143/AM17/ Lic.No/Date:0310806474 21.07.2016 Defer Date:08.03.2017 370

Case No.:20/13/82-

ALC4/2016 KABI ONCOLOGY LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred

62 HQ File :01/82/050/00648/AM17/ RLA File :05/23/040/00211/AM17/ Lic.No/Date:0510399202 22.07.2016 Defer Date:08.03.2017 371

Case No.:20/11/82-

ALC4/2016 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00554/AM17/ RLA File :03/95/040/00498/AM16/ Lic.No/Date:0310806509 22.07.2016 Defer Date:08.03.2017 372

Case No.:31/11/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00565/AM17/ RLA File :03/95/040/00168/AM17/ Lic.No/Date:0310806532 22.07.2016 Defer Date:08.03.2017 373

Case No.:7/13/82-ALC4/2016 Party Name:STYRAX

PHARMA PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00635/AM17/ RLA File :26/24/040/00013/AM17/ Lic.No/Date:2610012765 22.07.2016 Defer Date:08.03.2017 374

Case No.:70/11/82-

ALC4/2016 Party Name:ARCHI EXIM PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00604/AM17/ RLA File :08/24/040/00150/AM17/ Lic.No/Date:0810138353 25.07.2016 Defer Date:08.03.2017 375

Case No.:71/11/82-

ALC4/2016 Party Name:ARCHI EXIM PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00605/AM17/ RLA File :08/24/040/00151/AM17/ Lic.No/Date:0810138354 25.07.2016 Defer Date:08.03.2017 376

Case No.:144/13/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00772/AM17/ RLA File :08/24/040/00154/AM17/ Lic.No/Date:0810138352 25.07.2016 Defer Date:08.03.2017 377 Case No.:32/11/82- Party Name:STERLING Meet No/Date:17/82- Status:

63 ALC4/2016 AUXILIARIES PVT LTD ALC4/2016 24.01.2017 Deferred HQ File :01/82/050/00566/AM17/ RLA File :03/95/040/00290/AM17/ Lic.No/Date:0310806544 25.07.2016 Defer Date:08.03.2017 378

Case No.:55/11/82-

ALC4/2016 Party Name:SWISS PARENTERALS PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00589/AM17/ RLA File :08/24/040/00156/AM17/ Lic.No/Date:0810138362 25.07.2016 Defer Date:08.03.2017 379

Case No.:22/11/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00556/AM17/ RLA File :03/94/040/00262/AM17/ Lic.No/Date:0310806600 26.07.2016 Defer Date:08.03.2017 380

Case No.:65/13/82-ALC4/2016 Party Name:INDOCO

REMEDIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00693/AM17/ RLA File :03/94/040/00334/AM17/ Lic.No/Date:0310806610 26.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/522/2015-PI(Norms) dated 19.01.2016 for same 381

Case No.:77/11/82-

ALC4/2016 Party Name:ASIATIC DRUGS &PHARMACEUTICALS PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00611/AM17/ RLA File :05/23/040/00124/AM17/ Lic.No/Date:0510399240 27.07.2016 Defer Date:08.03.2017 382

Case No.:78/11/82-

ALC4/2016 Party Name:ASIATIC DRUGS &PHARMACEUTICALS PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00612/AM17/ RLA File :05/23/040/00123/AM17/ Lic.No/Date:0510399239 27.07.2016 Defer Date:08.03.2017 383

Case No.:79/11/82-

ALC4/2016 Party Name:ASIATIC DRUGS &PHARMACEUTICALS Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred

64 PVT. LTD. HQ File :01/82/050/00613/AM17/ RLA File :05/23/040/00119/AM17/ Lic.No/Date:0510399242 27.07.2016 Defer Date:08.03.2017 384

Case No.:80/11/82-

ALC4/2016 Party Name:ASIATIC DRUGS &PHARMACEUTICALS PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00614/AM17/ RLA File :05/23/040/00125/AM17/ Lic.No/Date:0510399241 27.07.2016 Defer Date:08.03.2017 385

Case No.:67/13/82-

ALC4/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00695/AM17/ RLA File :03/94/040/00335/AM17/ Lic.No/Date:0310806658 27.07.2016 Defer Date:08.03.2017 386

Case No.:84/13/82-

ALC4/2016 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00712/AM17/ RLA File :05/24/040/00170/AM17/ Lic.No/Date:0510399250 27.07.2016 Defer Date:08.03.2017 387

Case No.:64/13/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00692/AM17/ RLA File :03/94/040/00177/AM17/ Lic.No/Date:0310806697 28.07.2016 Defer Date:08.03.2017 388

Case No.:71/13/82-

ALC4/2016 Party Name:CIRON DRUGS & PHARMACEUTICALS P. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00699/AM17/ RLA File :03/94/040/00312/AM17/ Lic.No/Date:0310806768 01.08.2016 Defer Date:08.03.2017 389

Case No.:70/13/82-ALC4/2016 Party Name:INDOCO

REMEDIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00698/AM17/ RLA File :03/94/040/00344/AM17/ Lic.No/Date:0310806741 01.08.2016 Defer Date:

65 Pharmaceuticals forwarded vide O.M.No.35011/353/2015-PI(Norms) dated 11.11.2015 for same 390

Case No.:63/13/82-ALC4/2016 Party Name:KOPRAN

RESEARCH LABORATORIES LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00691/AM17/ RLA File :03/94/040/00280/AM17/ Lic.No/Date:0310806745 01.08.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/648/2013-PI(Norms) dated November 2014 for same export product , 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. 391

Case No.:35/13/82-ALC4/2016 Party Name:VENUS

REMEDIES LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00663/AM17/ RLA File :22/24/040/00036/AM17/ Lic.No/Date:2210015529 02.08.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/339/2014-PI(Norms) dated November 2014 for same export product , 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. 392

Case No.:34/13/82-ALC4/2016 Party Name:AMOL

PHARMACEUTICALS PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00662/AM17/ RLA File :13/24/040/00017/AM17/ Lic.No/Date:1310048326 03.08.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/47/2016-PI(Norms) dated 08.09.2016 for same 393

Case No.:112/17/82-

ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01073/AM17/ RLA File :07/24/040/00153/AM17/ Lic.No/Date:0710110200 04.08.2016 Defer Date: 08.03.2017 394

Case No.:73/13/82-

ALC4/2016 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00701/AM17/ RLA File :03/94/040/00354/AM17/ Lic.No/Date:0310806872 05.08.2016 Defer Date:08.03.2017

66 395

Case No.:74/17/82-ALC4/2016 Party Name:GLOBAL

CALCIUM PRIVATE LIMITED, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01035/AM17/ RLA File :07/24/040/00156/AM17/ Lic.No/Date:0710110223 05.08.2016 Defer Date: taken by NC in its meeting No.02/AM13 dated 10.04.2012, 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. 396

Case No.:74/13/82-ALC4/2016 Party Name:ALIVIRA

ANIMAL HEALTH LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00702/AM17/ RLA File :03/94/040/00367/AM17/ Lic.No/Date:0310806928 08.08.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/706/2015-PI(Norms) dated June 2016 for same 397

Case No.:72/13/82-

ALC4/2016 Party Name:INVENTIA HEALTHCARE PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00700/AM17/ RLA File :03/94/040/00356/AM17/ Lic.No/Date:0310806927 08.08.2016 Defer Date:08.03.2017 398

Case No.:59/13/82-ALC4/2016 Party Name:UPL

LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00687/AM17/ RLA File :03/95/040/00998/AM16/ Lic.No/Date:0310806923 08.08.2016 Defer Date: taken by NC in its meeting No.4/82 dated 16.05.2013, uploaded at the end of these minutes or as 399

Case No.:49/13/82-

ALC4/2016 Party Name:ALTA LABORATORIES LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00677/AM17/ RLA File :03/94/040/01052/AM16/ Lic.No/Date:0310806947 09.08.2016 Defer Date:08.03.2017 400

Case No.:50/13/82-

ALC4/2016 Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00678/AM17/ RLA File :03/94/040/00286/AM17/ Lic.No/Date:0310806966 09.08.2016 Defer Date:08.03.2017

67 401

Case No.:10/13/82-

ALC4/2016 KABI ONCOLOGY LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00638/AM17/ RLA File :05/23/040/00229/AM17/ Lic.No/Date:0510399392 09.08.2016 Defer Date:08.03.2017 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/764/2015-PI(Norms) dated 05.05.2016 uploaded at the end of these minutes and deferred the case. 402

Case No.:100/17/82-

ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01061/AM17/ RLA File :07/24/040/00154/AM17/ Lic.No/Date:0710110231 09.08.2016 Defer Date: 08.03.2017 403

Case No.:113/17/82-

ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01074/AM17/ RLA File :07/24/040/00155/AM17/ Lic.No/Date:0710110232 09.08.2016 Defer Date: 08.03.2017 404

Case No.:48/13/82-

ALC4/2016 Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00676/AM17/ RLA File :03/94/040/00386/AM17/ Lic.No/Date:0310806969 09.08.2016 Defer Date:08.03.2017 405

Case No.:26/13/82-

ALC4/2016 Party Name:VIVIMED LABS ( ALATHUR) PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00654/AM17/ RLA File :04/24/040/00065/AM17/ Lic.No/Date:0410162171 09.08.2016 Defer Date:08.03.2017 406

Case No.:8/13/82-ALC4/2016

Party Name:AKTINOS HEALTHCARE PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00636/AM17/ RLA File :09/24/040/00232/AM17/ Lic.No/Date:0910064019 10.08.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/42/2016-PI(Norms) dated August 2016 for same

68 407

Case No.:1/15/82-ALC4/2016 Party Name:JODAS EXPOIM

PVT.LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00815/AM17/ RLA File :05/23/040/00226/AM17/ Lic.No/Date:0510399403 10.08.2016 Defer Date:08.03.2017 408

Case No.:41/13/82-

ALC4/2016 Party Name:VIRDEV INTERMEDIATES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00669/AM17/ RLA File :52/24/040/00031/AM17/ Lic.No/Date:5210041993 10.08.2016 Defer Date:08.03.2017 409

Case No.:17/13/82-

ALC4/2016 Party Name:HELLO PAINTS (P) LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00645/AM17/ RLA File :05/23/040/00220/AM17/ Lic.No/Date:0510399449 11.08.2016 Defer Date:08.03.2017 410

Case No.:76/13/82-

ALC4/2016 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00704/AM17/ RLA File :03/94/040/00391/AM17/ Lic.No/Date:0310807030 11.08.2016 Defer Date:08.03.2017 411

Case No.:18/13/82-

ALC4/2016 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00646/AM17/ RLA File :05/23/040/00230/AM17/ Lic.No/Date:0510399442 11.08.2016 Defer Date:08.03.2017 412

Case No.:61/13/82-

ALC4/2016 Party Name:S M B CORPORATION OF INDIA Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00689/AM17/ RLA File :03/95/040/00388/AM17/ Lic.No/Date:0310807070 11.08.2016 Defer Date:08.03.2017 413

Case No.:78/13/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00706/AM17/ RLA File :03/94/040/00371/AM17/ Lic.No/Date:0310807104 12.08.2016 Defer Date:08.03.2017

69 414

Case No.:12/13/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00640/AM17/ RLA File :08/24/040/00196/AM17/ Lic.No/Date:0810138482 12.08.2016 Defer Date:08.03.2017 415

Case No.:15/13/82-

ALC4/2016 Party Name:TORRENT PHARMACEUTICALS LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00643/AM17/ RLA File :08/24/040/00184/AM17/ Lic.No/Date:0810138477 12.08.2016 Defer Date:08.03.2017 416

Case No.:53/13/82-

ALC4/2016 Party Name:CORAL LABORATORIES LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00681/AM17/ RLA File :03/94/040/00421/AM17/ Lic.No/Date:0310807134 16.08.2016 Defer Date:08.03.2017 417

Case No.:190/17/82-

ALC4/2016 Party Name:GLAND PHARMA LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01151/AM17/ RLA File :09/24/040/00223/AM17/ Lic.No/Date:0910064041 16.08.2016 Defer Date: 08.03.2017 418

Case No.:14/13/82-

ALC4/2016 Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00642/AM17/ RLA File :08/24/040/00181/AM17/ Lic.No/Date:0810138489 16.08.2016 Defer Date:08.03.2017 419

Case No.:16/13/82-

ALC4/2016 Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00644/AM17/ RLA File :08/24/040/00191/AM17/ Lic.No/Date:0810138490 16.08.2016 Defer Date:08.03.2017 420

Case No.:11/13/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred

70 HQ File :01/82/050/00639/AM17/ RLA File :08/24/040/00190/AM17/ Lic.No/Date:0810138500 17.08.2016 Defer Date:08.03.2017 421

Case No.:33/13/82-ALC4/2016 Party Name:IND-SWIFT

LABORATORIES LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00661/AM17/ RLA File :22/24/040/00044/AM17/ Lic.No/Date:2210015545 17.08.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/176/2016-PI(Norms) dated August 2016 for same export product , 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. 422

Case No.:52/13/82-

ALC4/2016 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00680/AM17/ RLA File :03/94/040/00160/AM17/ Lic.No/Date:0310807167 17.08.2016 Defer Date:08.03.2017 423

Case No.:40/13/82-

ALC4/2016 Party Name:AETHER INDUSTRIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00668/AM17/ RLA File :52/24/040/00036/AM17/ Lic.No/Date:5210042006 19.08.2016 Defer Date:08.03.2017 424

Case No.:19/13/82-

ALC4/2016 KABI ONCOLOGY LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00647/AM17/ RLA File :05/23/040/00234/AM17/ Lic.No/Date:0510399492 19.08.2016 Defer Date:08.03.2017 425

Case No.:142/13/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00770/AM17/ RLA File :05/24/040/00226/AM17/ Lic.No/Date:0510399509 19.08.2016 Defer Date:08.03.2017 426

Case No.:150/13/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00778/AM17/ RLA File :05/24/040/00201/AM17/ Lic.No/Date:0510399507 19.08.2016 Defer Date:08.03.2017

71 427

Case No.:152/13/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00780/AM17/ RLA File :05/24/040/00200/AM17/ Lic.No/Date:0510399505 19.08.2016 Defer Date:08.03.2017 Decision :Deferred. 428

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

Party Name:AMINES & Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00968/AM17/ RLA File :03/94/040/00437/AM17/ Lic.No/Date:0310807244 22.08.2016 Defer Date: 08.03.2017 Decision :Deferred. 429

Case No.:69/13/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00697/AM17/ RLA File :03/94/040/00339/AM17/ Lic.No/Date:0310807289 22.08.2016 Defer Date:08.03.2017 430

Case No.:158/13/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00786/AM17/ RLA File :05/23/040/00242/AM17/ Lic.No/Date:0510399523 22.08.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION A-412. RA concerned may take further necessary action as per decision of NC. 431

Case No.:112/13/82-

ALC4/2016 Party Name:AIMS IMPEX PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00740/AM17/ RLA File :03/94/040/00436/AM17/ Lic.No/Date:0310807309 23.08.2016 Defer Date:08.03.2017 432

Case No.:68/13/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00696/AM17/ RLA File :03/94/040/00453/AM17/ Lic.No/Date:0310807316 23.08.2016 Defer Date:08.03.2017 Decision : The representative of D/o Pharmaceuticals stated in the meeting that item of export and import pertain to D/o AYUSH. The Committee accordingly decided to forwarded copy of application to D/o AYUSH and deferred the case.

72 433

Case No.:156/13/82-

ALC4/2016 Party Name:MAHIMA LIFE SCIENCES PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00784/AM17/ RLA File :05/24/040/00214/AM17/ Lic.No/Date:0510399536 23.08.2016 Defer Date:08.03.2017 434

Case No.:157/13/82-

ALC4/2016 Party Name:MAHIMA LIFE SCIENCES PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00785/AM17/ RLA File :05/24/040/00215/AM17/ Lic.No/Date:0510399537 23.08.2016 Defer Date:08.03.2017 435

Case No.:141/13/82-

ALC4/2016 Party Name:RHYDBURG PHARMACEUTICALS LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00769/AM17/ RLA File :05/24/040/00239/AM17/ Lic.No/Date:0510399535 23.08.2016 Defer Date:08.03.2017 436

Case No.:75/13/82-

ALC4/2016 Party Name:ANUH PHARMA LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00703/AM17/ RLA File :03/94/040/00456/AM17/ Lic.No/Date:0310807339 24.08.2016 Defer Date:08.03.2017 437

Case No.:77/17/82-ALC4/2016 Party Name:TATVA

CHINTAN PHARMA CHEM PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01038/AM17/ RLA File :34/24/040/00152/AM17/ Lic.No/Date:3410042464 24.08.2016 Defer Date: taken by NC in its meeting No.26/82 dated 27.09.2011, uploaded at the end of these minutes or 438

Case No.:212/17/82-

ALC4/2016 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01173/AM17/ RLA File :09/24/040/00268/AM17/ Lic.No/Date:0910064076 25.08.2016 Defer Date: 08.03.2017 439 Case No.:94/13/82- ALC4/2016 Party Name:BODAL CHEMICALS LIMITED Meet No/Date:17/82- ALC4/2016 Status: Deferred

73 24.01.2017 HQ File :01/82/050/00722/AM17/ RLA File :08/24/040/00137/AM17/ Lic.No/Date:0810138556 29.08.2016 Defer Date:08.03.2017 440

Case No.:161/13/82-

ALC4/2016 KABI ONCOLOGY LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00789/AM17/ RLA File :05/23/040/00251/AM17/ Lic.No/Date:0510399568 29.08.2016 Defer Date:08.03.2017 441

Case No.:123/13/82-

ALC4/2016 Party Name:D. R. COATS INK & RESINS PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00751/AM17/ RLA File :03/94/040/00265/AM17/ Lic.No/Date:0310807443 30.08.2016 Defer Date:08.03.2017 442

Case No.:81/13/82-

ALC4/2016 Party Name:PANACEA BIOTEC LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00709/AM17/ RLA File :05/24/040/00258/AM17/ Lic.No/Date:0510399580 30.08.2016 Defer Date:08.03.2017 Decision :Deferred for comments from DBT. 443

Case No.:133/13/82-

ALC4/2016 DYE-CHEM PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00761/AM17/ RLA File :03/95/040/00239/AM17/ Lic.No/Date:0310807508 31.08.2016 Defer Date: taken by NC in its meeting No.39/82 dated 27.12.2011, uploaded at the end of these minutes or 444

Case No.:134/13/82-

ALC4/2016 DYE-CHEM PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00762/AM17/ RLA File :03/95/040/00249/AM17/ Lic.No/Date:0310807509 31.08.2016 Defer Date: 445

Case No.:132/13/82-

ALC4/2016 Party Name:ZIM LABORATORIES LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred

74 HQ File :01/82/050/00760/AM17/ RLA File :03/95/040/00448/AM17/ Lic.No/Date:0310807505 31.08.2016 Defer Date:08.03.2017 446

Case No.:124/13/82-

ALC4/2016 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00752/AM17/ RLA File :03/94/040/00464/AM17/ Lic.No/Date:0310807534 01.09.2016 Defer Date:08.03.2017 447

Case No.:121/13/82-

ALC4/2016 Party Name:GOPALDAS VISRAM & CO.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00749/AM17/ RLA File :03/94/040/00469/AM17/ Lic.No/Date:0310807553 01.09.2016 Defer Date:08.03.2017 448

Case No.:163/13/82-

ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00791/AM17/ RLA File :09/24/040/00285/AM17/ Lic.No/Date:0910064084 01.09.2016 Defer Date:08.03.2017 449

Case No.:164/13/82-

ALC4/2016 LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00792/AM17/ RLA File :09/24/040/00311/AM17/ Lic.No/Date:0910064091 01.09.2016 Defer Date:08.03.2017 450

Case No.:168/13/82-

ALC4/2016 LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00796/AM17/ RLA File :09/24/040/00301/AM17/ Lic.No/Date:0910064085 01.09.2016 Defer Date:08.03.2017 451

Case No.:170/13/82-

ALC4/2016 LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00798/AM17/ RLA File :09/24/040/00284/AM17/ Lic.No/Date:0910064083 01.09.2016 Defer Date:08.03.2017 452 Case No.:196/17/82- Party Name:ORCH Meet No/Date:17/82- Status:

75 ALC4/2016 LABORATORIES INDIA PVT LTD ALC4/2016 24.01.2017 Deferred HQ File :01/82/050/01157/AM17/ RLA File :09/24/040/00292/AM17/ Lic.No/Date:0910064089 01.09.2016 Defer Date: 08.03.2017 453

Case No.:95/13/82-

ALC4/2016 Party Name:ACULIFE HEALTHCARE PRIVATE LIMITED, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00723/AM17/ RLA File :08/24/040/00161/AM17/ Lic.No/Date:0810138597 02.09.2016 Defer Date:08.03.2017 454

Case No.:143/13/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00771/AM17/ RLA File :08/24/040/00124/AM17/ Lic.No/Date:0810138603 02.09.2016 Defer Date:08.03.2017 455

Case No.:146/13/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00774/AM17/ RLA File :22/24/040/00046/AM17/ Lic.No/Date:2210015557 02.09.2016 Defer Date:08.03.2017 456

Case No.:122/13/82-

ALC4/2016 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00750/AM17/ RLA File :03/94/040/00374/AM17/ Lic.No/Date:0310807578 02.09.2016 Defer Date:08.03.2017 457

Case No.:145/13/82-

ALC4/2016 Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00773/AM17/ RLA File :22/24/040/00049/AM17/ Lic.No/Date:2210015554 02.09.2016 Defer Date:08.03.2017 458

Case No.:109/13/82-

ALC4/2016 Party Name:AURA PHARMACEUTICALS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00737/AM17/ RLA File :03/94/040/00484/AM17/ Lic.No/Date:0310807613 06.09.2016 Defer Date:08.03.2017

76 459

Case No.:131/13/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00759/AM17/ RLA File :03/95/040/00248/AM17/ Lic.No/Date:0310807651 07.09.2016 Defer Date:08.03.2017 460

Case No.:135/13/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00763/AM17/ RLA File :03/95/040/00247/AM17/ Lic.No/Date:0310807650 07.09.2016 Defer Date:08.03.2017 461

Case No.:136/13/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00764/AM17/ RLA File :03/95/040/00311/AM17/ Lic.No/Date:0310807649 07.09.2016 Defer Date:08.03.2017 462

Case No.:202/17/82-

ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01163/AM17/ RLA File :09/24/040/00286/AM17/ Lic.No/Date:0910064118 08.09.2016 Defer Date: 08.03.2017 463

Case No.:197/17/82-

ALC4/2016 Party Name:EYTAN LABS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01158/AM17/ RLA File :09/24/040/00252/AM17/ Lic.No/Date:0910064110 08.09.2016 Defer Date: 08.03.2017 464

Case No.:210/17/82-

ALC4/2016 Party Name:GRANULES INDIA LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01171/AM17/ RLA File :09/24/040/00283/AM17/ Lic.No/Date:0910064111 08.09.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/262/2015-PI(Norms) dated Oct. 2015 for same 465 Case No.:167/13/82- ALC4/2016 LIMITED Meet No/Date:17/82- ALC4/2016 Status: Deferred

77 24.01.2017 HQ File :01/82/050/00795/AM17/ RLA File :09/24/040/00300/AM17/ Lic.No/Date:0910064112 08.09.2016 Defer Date:08.03.2017 466

Case No.:169/13/82-

ALC4/2016 LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00797/AM17/ RLA File :09/24/040/00302/AM17/ Lic.No/Date:0910064113 08.09.2016 Defer Date:08.03.2017 467

Case No.:209/17/82-

ALC4/2016 Party Name:INTERNATIONAL HEALTHCARE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01170/AM17/ RLA File :09/24/040/00246/AM17/ Lic.No/Date:0910064103 08.09.2016 Defer Date: 08.03.2017 468

Case No.:108/13/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00736/AM17/ RLA File :03/94/040/00506/AM17/ Lic.No/Date:0310807686 08.09.2016 Defer Date:08.03.2017 469

Case No.:207/17/82-

ALC4/2016 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01168/AM17/ RLA File :09/24/040/00310/AM17/ Lic.No/Date:0910064117 08.09.2016 Defer Date: 08.03.2017 470

Case No.:137/13/82-

ALC4/2016 Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00765/AM17/ RLA File :03/95/040/00437/AM17/ Lic.No/Date:0310807709 08.09.2016 Defer Date:08.03.2017 471

Case No.:186/17/82-

ALC4/2016 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01147/AM17/ RLA File :09/24/040/00231/AM17/ Lic.No/Date:0910064100 08.09.2016 Defer Date: 08.03.2017

78 472

Case No.:199/17/82-

ALC4/2016 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01160/AM17/ RLA File :09/24/040/00075/AM17/ Lic.No/Date:0910064099 08.09.2016 Defer Date: 08.03.2017 473

Case No.:159/13/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00787/AM17/ RLA File :05/24/040/00264/AM17/ Lic.No/Date:0510399649 08.09.2016 Defer Date:08.03.2017 474

Case No.:208/17/82-

ALC4/2016 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01169/AM17/ RLA File :09/24/040/00256/AM17/ Lic.No/Date:0910064101 08.09.2016 Defer Date: 08.03.2017 475

Case No.:98/13/82-ALC4/2016 Party Name:CADILA

PHARMACEUTICALS LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00726/AM17/ RLA File :08/24/040/00235/AM17/ Lic.No/Date:0810138637 09.09.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION A-412. RA concerned may take further necessary action as per decision of NC. 476

Case No.:162/13/82-

ALC4/2016 Party Name:HETERO DRUGS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00790/AM17/ RLA File :09/24/040/00309/AM17/ Lic.No/Date:0910064122 09.09.2016 Defer Date:08.03.2017 477

Case No.:166/13/82-

ALC4/2016 LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00794/AM17/ RLA File :09/24/040/00314/AM17/ Lic.No/Date:0910064123 09.09.2016 Defer Date:08.03.2017 478

Case No.:165/13/82-

ALC4/2016 Party Name:HONOUR LAB LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File RLA File Lic.No/Date:0910064126 Defer

79 :01/82/050/00793/AM17/ :09/24/040/00321/AM17/ 09.09.2016 Date:08.03.2017 479

Case No.:206/17/82-

ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01167/AM17/ RLA File :09/24/040/00277/AM17/ Lic.No/Date:0910064133 12.09.2016 Defer Date: 08.03.2017 480

Case No.:93/13/82-

ALC4/2016 Party Name:MAHIMA LIFE SCIENCES PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00721/AM17/ RLA File :05/24/040/00217/AM17/ Lic.No/Date:0510399726 15.09.2016 Defer Date:08.03.2017 481

Case No.:105/13/82-

ALC4/2016 Party Name:AARTI DRUGS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00733/AM17/ RLA File :03/94/040/00487/AM17/ Lic.No/Date:0310807836 16.09.2016 Defer Date:08.03.2017 482

Case No.:107/13/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00735/AM17/ RLA File :03/94/040/00540/AM17/ Lic.No/Date:0310807829 16.09.2016 Defer Date:08.03.2017 483

Case No.:46/13/82-

ALC4/2016 Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00674/AM17/ RLA File :08/24/040/00215/AM17/ Lic.No/Date:0810138683 16.09.2016 Defer Date:08.03.2017 484

Case No.:153/13/82-

ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00781/AM17/ RLA File :05/23/040/00265/AM17/ Lic.No/Date:0510399737 16.09.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION A-3649 published earlier. RA concerned may take further necessary action as per decision of NC. 485 Case No.:155/13/82- Party Name:JODAS EXPOIM Meet No/Date:17/82- Status:

80 ALC4/2016 PVT.LTD., ALC4/2016 24.01.2017 Approved HQ File :01/82/050/00783/AM17/ RLA File :05/23/040/00264/AM17/ Lic.No/Date:0510399736 16.09.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION A-3649 published earlier. RA concerned may take further necessary action as per decision of NC. 486

Case No.:129/13/82-

ALC4/2016 DYE-CHEM PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00757/AM17/ RLA File :03/95/040/00313/AM17/ Lic.No/Date:0310807812 16.09.2016 Defer Date: 487

Case No.:211/17/82-

ALC4/2016 Party Name:DIVIS PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01172/AM17/ RLA File :09/24/040/00270/AM17/ Lic.No/Date:0910064148 19.09.2016 Defer Date: 08.03.2017 488

Case No.:103/13/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00731/AM17/ RLA File :03/94/040/00516/AM17/ Lic.No/Date:0310807914 20.09.2016 Defer Date:08.03.2017 489

Case No.:43/13/82-

ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00671/AM17/ RLA File :09/24/040/00303/AM17/ Lic.No/Date:0910064168 21.09.2016 Defer Date:08.03.2017 490

Case No.:119/13/82-

ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00747/AM17/ RLA File :07/24/040/00207/AM17/ Lic.No/Date:0710110442 21.09.2016 Defer Date:08.03.2017 491 Case No.:45/13/82- ALC4/2016 Party Name:BIO TECH OPHTHALMICS PVT LTD Meet No/Date:17/82- ALC4/2016 Status: Deferred

81 24.01.2017 HQ File :01/82/050/00673/AM17/ RLA File :08/24/040/00216/AM17/ Lic.No/Date:0810138715 22.09.2016 Defer Date:08.03.2017 492

Case No.:91/13/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00719/AM17/ RLA File :08/24/040/00242/AM17/ Lic.No/Date:0810138723 22.09.2016 Defer Date:08.03.2017 493

Case No.:92/13/82-ALC4/2016 Party Name:CADILA

HEALTHCARE LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00720/AM17/ RLA File :08/24/040/00243/AM17/ Lic.No/Date:0810138725 22.09.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION A-412 published earlier. RA concerned may take further necessary action as per decision of NC. 494

Case No.:100/13/82-

ALC4/2016 Party Name:K V AROCHEM PVT. LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00728/AM17/ RLA File :03/94/040/00525/AM17/ Lic.No/Date:0310807975 22.09.2016 Defer Date:08.03.2017 495

Case No.:192/17/82-

ALC4/2016 Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01153/AM17/ RLA File :09/24/040/00332/AM17/ Lic.No/Date:0910064172 22.09.2016 Defer Date: 08.03.2017 496

Case No.:82/13/82-

ALC4/2016 Party Name:VERTELLUS SPECIALTY MATERIALS (INDIA) PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00710/AM17/ RLA File :52/24/040/00040/AM17/ Lic.No/Date:5210042029 22.09.2016 Defer Date:08.03.2017 497

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

Party Name:MANGALAM DRUGS & ORGANICS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00965/AM17/ RLA File :03/95/040/00322/AM17/ Lic.No/Date:0310808020 23.09.2016 Defer Date: 08.03.2017

82 498

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

& PHARMACEUTICALS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01017/AM17/ RLA File :03/94/040/00582/AM17/ Lic.No/Date:0310808049 26.09.2016 Defer Date: 08.03.2017 499

Case No.:102/17/82-

ALC4/2016 Party Name:PAB ORGANICS PVT.LTD, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01063/AM17/ RLA File :34/24/040/00180/AM17/ Lic.No/Date:3410042558 26.09.2016 Defer Date: 08.03.2017 500

Case No.:193/17/82-

ALC4/2016 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01154/AM17/ RLA File :09/24/040/00345/AM17/ Lic.No/Date:0910064185 26.09.2016 Defer Date: 08.03.2017 501

Case No.:195/17/82-

ALC4/2016 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01156/AM17/ RLA File :09/24/040/00344/AM17/ Lic.No/Date:0910064184 26.09.2016 Defer Date: 08.03.2017 502

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

Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01016/AM17/ RLA File :03/94/040/00570/AM17/ Lic.No/Date:0310808091 27.09.2016 Defer Date: 08.03.2017 503

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

ORGANICS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00974/AM17/ RLA File :03/94/040/00585/AM17/ Lic.No/Date:0310808096 27.09.2016 Defer Date: 08.03.2017 504

Case No.:113/13/82-

ALC4/2016 LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00741/AM17/ RLA File :09/24/040/00342/AM17/ Lic.No/Date:0910064191 27.09.2016 Defer Date:08.03.2017

83 505

Case No.:114/13/82-

ALC4/2016 LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00742/AM17/ RLA File :09/24/040/00341/AM17/ Lic.No/Date:0910064192 27.09.2016 Defer Date:08.03.2017 506

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

PVT. LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01015/AM17/ RLA File :03/94/040/00524/AM17/ Lic.No/Date:0310808098 27.09.2016 Defer Date: 08.03.2017 507

Case No.:139/13/82-

ALC4/2016 Party Name:VISWAAT CHEMICALS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00767/AM17/ RLA File :03/95/040/00302/AM17/ Lic.No/Date:0310808110 27.09.2016 Defer Date:08.03.2017 508

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

INDIA PRIVATE LIMITED. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01019/AM17/ RLA File :03/94/040/00583/AM17/ Lic.No/Date:0310808142 28.09.2016 Defer Date: 08.03.2017 509

Case No.:99/13/82-

ALC4/2016 Party Name:ATUL LIMITED, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00727/AM17/ RLA File :08/24/040/00214/AM17/ Lic.No/Date:0810138766 29.09.2016 Defer Date:08.03.2017 510

Case No.:51/17/82-ALC4/2016 Party Name:INDOCO

REMEDIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01012/AM17/ RLA File :03/94/040/00594/AM17/ Lic.No/Date:0310808170 29.09.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/522/2015-PI(Norms) dated 19.01.2016 for same 511 Case No.:53/17/82-ALC4/2016 Party Name:INDOCO Meet No/Date:17/82- Status:

84 REMEDIES LIMITED ALC4/2016 24.01.2017 Approved HQ File :01/82/050/01014/AM17/ RLA File :03/94/040/00595/AM17/ Lic.No/Date:0310808171 29.09.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/29/2016-PI(Norms) dated 19.12.2016 for same 512

Case No.:191/17/82-

ALC4/2016 Party Name:SHREEGEN PHARMA LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01152/AM17/ RLA File :09/24/040/00333/AM17/ Lic.No/Date:0910064204 29.09.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/182/2016-PI(Norms) dated August 2016 for same export product , 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. 513

Case No.:68/17/82-ALC4/2016 Party Name:SUVEN LIFE

SCIENCES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01029/AM17/ RLA File :09/24/040/00351/AM17/ Lic.No/Date:0910064205 29.09.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/761/2013-PI(Norms) dated 04.03.2014, uploaded Vol.1. RA concerned may take necessary action as per decision of NC 514

Case No.:194/17/82-

ALC4/2016 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01155/AM17/ RLA File :09/24/040/00339/AM17/ Lic.No/Date:0910064206 29.09.2016 Defer Date: 08.03.2017 515

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

ANIMAL HEALTH LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00973/AM17/ RLA File :03/94/040/00557/AM17/ Lic.No/Date:0310808216 30.09.2016 Defer Date: 08.03.2017 516

Case No.:90/13/82-

ALC4/2016 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00718/AM17/ RLA File :52/24/040/00042/AM17/ Lic.No/Date:5210042032 30.09.2016 Defer Date:08.03.2017

85 517

Case No.:188/17/82-

ALC4/2016 Party Name:GLAND PHARMA LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01149/AM17/ RLA File :09/24/040/00357/AM17/ Lic.No/Date:0910064221 30.09.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/53/2014-PI(Norms) dated Oct. 2014 for same 518

Case No.:125/13/82-

ALC4/2016 Party Name:SURVIVAL Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00753/AM17/ RLA File :03/95/040/00490/AM17/ Lic.No/Date:0310808208 30.09.2016 Defer Date:08.03.2017 519

Case No.:126/13/82-

ALC4/2016 Party Name:SURVIVAL Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00754/AM17/ RLA File :03/95/040/00410/AM17/ Lic.No/Date:0310808209 30.09.2016 Defer Date:08.03.2017 520

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

INDUSTRIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01024/AM17/ RLA File :03/94/040/00559/AM17/ Lic.No/Date:0310808233 03.10.2016 Defer Date: 08.03.2017 521

Case No.:16/17/82-ALC4/2016 Party Name:BENZO CHEM

INDUSTRIES PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00977/AM17/ RLA File :03/94/040/00588/AM17/ Lic.No/Date:0310808240 03.10.2016 Defer Date: Decision : The Committee decided to ratify norms 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. 522

Case No.:182/17/82-

ALC4/2016 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01143/AM17/ RLA File :09/24/040/00305/AM17/ Lic.No/Date:0910064230 05.10.2016 Defer Date: 08.03.2017

86 523

Case No.:183/17/82-

ALC4/2016 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01144/AM17/ RLA File :09/24/040/00323/AM17/ Lic.No/Date:0910064231 05.10.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/532/2012-PI(Norms) dated 26.12.2012 for same 524

Case No.:204/17/82-

ALC4/2016 Party Name:NAGARJUNA AGRICHEM LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01165/AM17/ RLA File :09/24/040/00313/AM17/ Lic.No/Date:0910064232 05.10.2016 Defer Date: 08.03.2017 525

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

PAINTS AND CHEMICALS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00990/AM17/ RLA File :03/95/040/00514/AM17/ Lic.No/Date:0310808276 05.10.2016 Defer Date: 08.03.2017 526

Case No.:200/17/82-

ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01161/AM17/ RLA File :09/24/040/00312/AM17/ Lic.No/Date:0910064252 06.10.2016 Defer Date: 08.03.2017 527

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

Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00972/AM17/ RLA File :03/94/040/00617/AM17/ Lic.No/Date:0310808312 06.10.2016 Defer Date: 08.03.2017 528

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

SYNTHESIS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01036/AM17/ RLA File :52/24/040/00043/AM17/ Lic.No/Date:5210042038 06.10.2016 Defer Date: 08.03.2017 529 Case No.:189/17/82- Party Name:MYLAN Meet No/Date:17/82- Status:

87 ALC4/2016 LABORATORIES LIMITED ALC4/2016 24.01.2017 Approved HQ File :01/82/050/01150/AM17/ RLA File :09/24/040/00324/AM17/ Lic.No/Date:0910064244 06.10.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/379/2012-PI(Norms) dated Oct. 2012 for same 530

Case No.:205/17/82-

ALC4/2016 Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01166/AM17/ RLA File :09/24/040/00375/AM17/ Lic.No/Date:0910064235 06.10.2016 Defer Date: 08.03.2017 531

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

INDUSTRIES PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00991/AM17/ RLA File :03/95/040/00532/AM17/ Lic.No/Date:0310808294 06.10.2016 Defer Date: 08.03.2017 532

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

Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00971/AM17/ RLA File :03/94/040/00614/AM17/ Lic.No/Date:0310808345 07.10.2016 Defer Date: 08.03.2017 533

Case No.:203/17/82-

ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01164/AM17/ RLA File :09/24/040/00330/AM17/ Lic.No/Date:0910064257 10.10.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION A-412. RA concerned may take further necessary action as per decision of NC. 534

Case No.:46/17/82-ALC4/2016 Party Name:BENZO CHEM

INDUSTRIES PRIVATE LIMITED, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01007/AM17/ RLA File :03/94/040/00615/AM17/ Lic.No/Date:0310808360 10.10.2016 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.18/82 dated 30.08.2012, 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.

88 535

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

INDUSTRIES PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00994/AM17/ RLA File :03/95/040/00546/AM17/ Lic.No/Date:0310808376 13.10.2016 Defer Date: 08.03.2017 536

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

LABORATORIES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01030/AM17/ RLA File :09/24/040/00374/AM17/ Lic.No/Date:0910064265 14.10.2016 Defer Date: 08.03.2017 537

Case No.:201/17/82-

ALC4/2016 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01162/AM17/ RLA File :09/24/040/00354/AM17/ Lic.No/Date:0910064264 14.10.2016 Defer Date: 08.03.2017 538

Case No.:49/17/82-ALC4/2016 Party Name:CIPLA LIMITED.

Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01010/AM17/ RLA File :03/94/040/00622/AM17/ Lic.No/Date:0310808433 17.10.2016 Defer Date: 08.03.2017 539

Case No.:8/17/82-ALC4/2016

Party Name:CLARIANT INDIA LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00969/AM17/ RLA File :03/94/040/00628/AM17/ Lic.No/Date:0310808421 17.10.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/138/2011-Ch-II dated 14.09.2015 for same export product , 540

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

Party Name:CLARIANT INDIA LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00970/AM17/ RLA File :03/94/040/00629/AM17/ Lic.No/Date:0310808422 17.10.2016 Defer Date: 08.03.2017 541

Case No.:44/17/82-ALC4/2016 Party Name:ENALTEC LABS

PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved

89 HQ File :01/82/050/01005/AM17/ RLA File :03/94/040/00635/AM17/ Lic.No/Date:0310808434 17.10.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/487/2012-PI(Norms) dated 14 November 2012, 542

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

LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01000/AM17/ RLA File :03/95/040/00324/AM17/ Lic.No/Date:0310808410 17.10.2016 Defer Date: 08.03.2017 543

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

PHARMACEUTICALS Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00992/AM17/ RLA File :03/95/040/00540/AM17/ Lic.No/Date:0310808412 17.10.2016 Defer Date: 08.03.2017 544

Case No.:86/13/82-ALC4/2016 Party Name:SUN

PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00714/AM17/ RLA File :05/24/040/00320/AM17/ Lic.No/Date:0510400111 17.10.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/781/2015-PI(Norms) dated October 2015 for same export product , 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. 545

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

INDIA LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00986/AM17/ RLA File :03/94/040/00648/AM17/ Lic.No/Date:0310808508 18.10.2016 Defer Date: 08.03.2017 546

Case No.:42/17/82-ALC4/2016 Party Name:CLARIANT

INDIA LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01003/AM17/ RLA File :03/94/040/00647/AM17/ Lic.No/Date:0310808506 18.10.2016 Defer Date: its meeting No.09/82 dated 25.07.2013 for same export product , uploaded at the end of these

90 547

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

INDUSTRIES LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01025/AM17/ RLA File :03/95/040/00457/AM17/ Lic.No/Date:0310808513 18.10.2016 Defer Date: 08.03.2017 548

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

LABORATORIES PVT.LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00993/AM17/ RLA File :03/95/040/00551/AM17/ Lic.No/Date:0310808488 18.10.2016 Defer Date: 08.03.2017 549

Case No.:48/17/82-ALC4/2016 Party Name:ENALTEC LABS

PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01009/AM17/ RLA File :03/94/040/00633/AM17/ Lic.No/Date:0310808536 19.10.2016 Defer Date: its meeting No.14/82 dated 24.10.2013 for same export product , uploaded at the end of these 550

Case No.:28/17/82-ALC4/2016 Party Name:SUNSHIELD

CHEMICALS LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00989/AM17/ RLA File :03/95/040/00573/AM17/ Lic.No/Date:0310808548 19.10.2016 Defer Date: its meeting No.21/82 dated 23.08.2011 for same export product , uploaded at the end of these 551

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

PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01011/AM17/ RLA File :03/94/040/00639/AM17/ Lic.No/Date:0310808566 20.10.2016 Defer Date: 08.03.2017 552

Case No.:214/17/82-

ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01175/AM17/ RLA File :31/83/040/00071/AM17/ Lic.No/Date:3110066376 20.10.2016 Defer Date: 08.03.2017 553 Case No.:47/17/82-ALC4/2016 Party Name:GLENMARK Meet No/Date:17/82- Status:

91 PHARMACEUTICALS LTD., ALC4/2016 24.01.2017 Deferred HQ File :01/82/050/01008/AM17/ RLA File :03/94/040/00661/AM17/ Lic.No/Date:0310808581 20.10.2016 Defer Date: 08.03.2017 554

Case No.:36/17/82-ALC4/2016 Party Name:SUNSHIELD

CHEMICALS LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00997/AM17/ RLA File :03/95/040/00580/AM17/ Lic.No/Date:0310808584 20.10.2016 Defer Date: its meeting No.08/82 dated 25.09.2014 for same export product , uploaded at the end of these 555

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

MEDISCIENCES LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00995/AM17/ RLA File :03/95/040/00462/AM17/ Lic.No/Date:0310808576 20.10.2016 Defer Date: 08.03.2017 556

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

LABORATORIES, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01018/AM17/ RLA File :03/94/040/00526/AM17/ Lic.No/Date:0310808624 21.10.2016 Defer Date: 08.03.2017 557

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

INTERNATIONAL Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01037/AM17/ RLA File :52/24/040/00046/AM17/ Lic.No/Date:5210042057 25.10.2016 Defer Date: 08.03.2017 558

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

PHARMACHEM LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01055/AM17/ RLA File :34/24/040/00204/AM17/ Lic.No/Date:3410042618 25.10.2016 Defer Date: 08.03.2017 559

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

CHEMICALS LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File RLA File Lic.No/Date:0310808689 Defer Date:

92 :01/82/050/00985/AM17/ :03/95/040/00582/AM17/ 25.10.2016 08.03.2017 560

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

INDUSTRIES PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00996/AM17/ RLA File :03/95/040/00594/AM17/ Lic.No/Date:0310808711 25.10.2016 Defer Date: 08.03.2017 561

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

LIFESCIENCE PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00976/AM17/ RLA File :03/94/040/00672/AM17/ Lic.No/Date:0310808773 26.10.2016 Defer Date: 08.03.2017 562

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

ORGANICS PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00981/AM17/ RLA File :03/94/040/00606/AM17/ Lic.No/Date:0310808832 27.10.2016 Defer Date: 08.03.2017 563

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

ORGANICS PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00982/AM17/ RLA File :03/94/040/00548/AM17/ Lic.No/Date:0310808830 27.10.2016 Defer Date: 08.03.2017 564

Case No.:23/17/82-ALC4/2016 Party Name:HARMONY

LIFESCIENCE PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00984/AM17/ RLA File :03/94/040/00673/AM17/ Lic.No/Date:0310808804 27.10.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/509/2012-PI(Norms) dated 14.11.2012 for same 565

Case No.:93/17/82-ALC4/2016 Party Name:ALEMBIC

PHARMACEUTICALS LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01054/AM17/ RLA File :34/24/040/00195/AM17/ Lic.No/Date:3410042633 28.10.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/582/2015-PI(Norms) dated 10.03.2016 for same

93 566

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

BIOTECH LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01056/AM17/ RLA File :08/24/040/00268/AM17/ Lic.No/Date:0810138997 28.10.2016 Defer Date: 08.03.2017 567

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

PHARMACEUTICALS LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01013/AM17/ RLA File :03/94/040/00658/AM17/ Lic.No/Date:0310808927 02.11.2016 Defer Date: 08.03.2017 568

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

INDUSTRIES PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01001/AM17/ RLA File :03/95/040/00616/AM17/ Lic.No/Date:0310808975 04.11.2016 Defer Date: 08.03.2017 569

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

INDUSTRIES PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01020/AM17/ RLA File :03/95/040/00617/AM17/ Lic.No/Date:0310808973 04.11.2016 Defer Date: 08.03.2017 570

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

SCIENCES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00988/AM17/ RLA File :03/95/040/00621/AM17/ Lic.No/Date:0310809008 07.11.2016 Defer Date: 08.03.2017 571

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

PHARMACEUTICALS LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00975/AM17/ RLA File :03/94/040/00717/AM17/ Lic.No/Date:0310809031 08.11.2016 Defer Date: 08.03.2017 572

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

& PHARMACEUTICALS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred

94 HQ File :01/82/050/00979/AM17/ RLA File :03/94/040/00718/AM17/ Lic.No/Date:0310809038 08.11.2016 Defer Date: 08.03.2017 573

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

& PHARMACEUTICALS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01004/AM17/ RLA File :03/94/040/00703/AM17/ Lic.No/Date:0310809039 08.11.2016 Defer Date: 08.03.2017 574

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

& PHARMACEUTICALS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00983/AM17/ RLA File :03/94/040/00726/AM17/ Lic.No/Date:0310809070 09.11.2016 Defer Date: 08.03.2017 575

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

PHARMACHEM LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01049/AM17/ RLA File :34/24/040/00220/AM17/ Lic.No/Date:3410042652 09.11.2016 Defer Date: 08.03.2017 576

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

AUXILIARIES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00987/AM17/ RLA File :03/95/040/00348/AM17/ Lic.No/Date:0310809069 09.11.2016 Defer Date: 08.03.2017 577

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

AUXILIARIES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00998/AM17/ RLA File :03/95/040/00344/AM17/ Lic.No/Date:0310809065 09.11.2016 Defer Date: 08.03.2017 578

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

INDUSTRIES PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00999/AM17/ RLA File :03/95/040/00630/AM17/ Lic.No/Date:0310809075 09.11.2016 Defer Date: 08.03.2017 579 Case No.:17/17/82-ALC4/2016 Party Name:J.B. CHEMICALS Meet No/Date:17/82- Status:

95 & PHARMACEUTICALS LIMITED ALC4/2016 24.01.2017 Deferred HQ File :01/82/050/00978/AM17/ RLA File :03/94/040/00730/AM17/ Lic.No/Date:0310809095 10.11.2016 Defer Date: 08.03.2017 580

Case No.:45/17/82-ALC4/2016 Party Name:KRISHNA

ANTIOXIDANTS PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01006/AM17/ RLA File :03/94/040/00704/AM17/ Lic.No/Date:0310809094 10.11.2016 Defer Date: 08.03.2017 581

Case No.:2/15/82-ALC4/2016 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00816/AM17/ RLA File :03/95/040/00449/AM17/ Lic.No/Date:0310809088 10.11.2016 Defer Date:08.03.2017 582

Case No.:41/17/82-ALC4/2016 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01002/AM17/ RLA File :03/95/040/00515/AM17/ Lic.No/Date:0310809091 10.11.2016 Defer Date: 08.03.2017 583

Case No.:103/17/82-

ALC4/2016 KABI ONCOLOGY LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01064/AM17/ RLA File :05/23/040/00370/AM17/ Lic.No/Date:0510400406 11.11.2016 Defer Date: 08.03.2017 584

Case No.:19/17/82-ALC4/2016 Party Name:HIKAL LIMITED

Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00980/AM17/ RLA File :03/94/040/00687/AM17/ Lic.No/Date:0310809149 11.11.2016 Defer Date: 08.03.2017 585

Case No.:101/17/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01062/AM17/ RLA File :05/23/040/00372/AM17/ Lic.No/Date:0510400404 11.11.2016 Defer Date: 08.03.2017

96 586

Case No.:62/17/82-ALC4/2016 Party Name:BALAJI AMINES

LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01023/AM17/ RLA File :31/83/040/00107/AM17/ Lic.No/Date:3110066399 21.11.2016 Defer Date: Decision : The Committee decided to ratify norms based on the earlier recommendation of D/o C&PC forwarded vide U.O.No.14010/122/2011-Ch-II dated 11.02.2016, 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. 587

Case No.:130/17/82-

ALC4/2016 Party Name:BAYER VAPI PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01091/AM17/ RLA File :03/94/040/00735/AM17/ Lic.No/Date:0310809204 22.11.2016 Defer Date: 08.03.2017 58 8

Case No.:92/17/82-

ALC4/2016 Party Name:JAINEX SPECIALITY CHEMIC AL Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01053/AM1 7/ RLA File :34/24/040/00215/AM17/ Lic.No/Date:3410042669 22.11.2016 Defer Date: Decision : The Committee decided to ratify norms based on the earlier recommendation of D/o C&PC forwarded vide U.O.No.14010/16/2014-Ch-II dated 13.06.2014, 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. 589

Case No.:138/17/82-

ALC4/2016 Party Name:MAPLE CROSS REMEDIES PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01099/AM17/ RLA File :03/95/040/00624/AM17/ Lic.No/Date:0310809210 22.11.2016 Defer Date: 08.03.2017 590

Case No.:140/17/82-

ALC4/2016 Party Name:MEDISPRAY LABORATORIES PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01101/AM17/ RLA File :03/95/040/00613/AM17/ Lic.No/Date:0310809212 22.11.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/442/2011-PI(Norms) dated 22.2.2012 for same 591

Case No.:66/17/82-ALC4/2016 Party Name:MEGHMANI

INDUSTRIES LTD, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File RLA File Lic.No/Date:0810139050 Defer Date:

97 :01/82/050/01027/AM17/ :08/24/040/00293/AM17/ 22.11.2016 08.03.2017 592

Case No.:122/17/82-

ALC4/2016 DYE-CHEM PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01083/AM17/ RLA File :03/95/040/00539/AM17/ Lic.No/Date:0310809226 22.11.2016 Defer Date: 593

Case No.:125/17/82-

ALC4/2016 DYE-CHEM PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01086/AM17/ RLA File :03/95/040/00527/AM17/ Lic.No/Date:0310809225 22.11.2016 Defer Date: taken by NC in its meeting No.39/82 dated 27.12.2011, uploaded at the end of these minutes or 594

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

CHEMICALS Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01052/AM17/ RLA File :34/24/040/00224/AM17/ Lic.No/Date:3410042673 22.11.2016 Defer Date: 08.03.2017: 595

Case No.:124/17/82-

ALC4/2016 Party Name:SURVIVAL Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01085/AM17/ RLA File :03/95/040/00639/AM17/ Lic.No/Date:0310809216 22.11.2016 Defer Date: 08.03.2017 596

Case No.:121/17/82-

ALC4/2016 Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01082/AM17/ RLA File :03/95/040/00622/AM17/ Lic.No/Date:0310809222 22.11.2016 Defer Date: taken by NC in its meeting No.23/82 dated 01.11.2012, uploaded at the end of these minutes or 597 Case No.:120/17/82- ALC4/2016 Party Name:ZIM LABORATORIES LTD. Meet No/Date:17/82- ALC4/2016 Status: Deferred

98 24.01.2017 HQ File :01/82/050/01081/AM17/ RLA File :03/95/040/00602/AM17/ Lic.No/Date:0310809205 22.11.2016 Defer Date: 08.03.2017 598

Case No.:141/17/82-

ALC4/2016 Party Name:MELOG SPECIALITY CHEMICALS PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01102/AM17/ RLA File :03/95/040/00610/AM17/ Lic.No/Date:0310809264 23.11.2016 Defer Date: 08.03.2017 599

Case No.:98/17/82-ALC4/2016 Party Name:NECTAR

LIFESCIENCES LIMITED, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01059/AM17/ RLA File :22/24/040/00071/AM17/ Lic.No/Date:2210015595 23.11.2016 Defer Date: 08.03.2017 600

Case No.:123/17/82-

ALC4/2016 DYE-CHEM PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01084/AM17/ RLA File :03/95/040/00521/AM17/ Lic.No/Date:0310809262 23.11.2016 Defer Date: 601

Case No.:99/17/82-ALC4/2016 Party Name:SAURAV

CHEMICALS LTD, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01060/AM17/ RLA File :22/24/040/00073/AM17/ Lic.No/Date:2210015598 23.11.2016 Defer Date: 08.03.2017 602

Case No.:1/17/82-ALC4/2016

Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/00962/AM17/ RLA File :03/95/040/00640/AM17/ Lic.No/Date:0310809268 23.11.2016 Defer Date: 08.03.2017 603

Case No.:87/17/82-ALC4/2016 Party Name:ASIATIC DRUGS

&PHARMACEUTICALS PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01048/AM17/ RLA File :05/23/040/00365/AM17/ Lic.No/Date:0510400453 24.11.2016 Defer Date: 08.03.2017

99 604

Case No.:86/17/82-ALC4/2016 Party Name:ALCHEM

INTERNATIONAL PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01047/AM17/ RLA File :05/23/040/00358/AM17/ Lic.No/Date:0510400474 25.11.2016 Defer Date: 08.03.2017 605

Case No.:155/17/82-

ALC4/2016 Party Name:CIPLA LIMITED. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01116/AM17/ RLA File :03/94/040/00757/AM17/ Lic.No/Date:0310809323 25.11.2016 Defer Date: 08.03.2017 606

Case No.:161/17/82-

ALC4/2016 Party Name:ENALTEC LABS PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01122/AM17/ RLA File :03/94/040/00755/AM17/ Lic.No/Date:0310809329 25.11.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/487/2012-PI(Norms) dated 14 November 2012, 607

Case No.:162/17/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01123/AM17/ RLA File :03/94/040/00678/AM17/ Lic.No/Date:0310809339 28.11.2016 Defer Date: 08.03.2017 608

Case No.:168/17/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01129/AM17/ RLA File :03/94/040/00707/AM17/ Lic.No/Date:0310809340 28.11.2016 Defer Date: 08.03.2017 609

Case No.:169/17/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01130/AM17/ RLA File :03/94/040/00709/AM17/ Lic.No/Date:0310809344 28.11.2016 Defer Date: 08.03.2017 610 Case No.:170/17/82- Party Name:AVA Meet No/Date:17/82- Status:

100 ALC4/2016 CHEMICALS PVT.LTD., ALC4/2016 24.01.2017 Deferred HQ File :01/82/050/01131/AM17/ RLA File :03/94/040/00708/AM17/ Lic.No/Date:0310809341 28.11.2016 Defer Date: 08.03.2017 611

Case No.:171/17/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01132/AM17/ RLA File :03/94/040/00732/AM17/ Lic.No/Date:0310809343 28.11.2016 Defer Date: 08.03.2017 612

Case No.:172/17/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01133/AM17/ RLA File :03/94/040/00710/AM17/ Lic.No/Date:0310809345 28.11.2016 Defer Date: 08.03.2017 613

Case No.:179/17/82-

ALC4/2016 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01140/AM17/ RLA File :03/94/040/00744/AM17/ Lic.No/Date:0310809373 28.11.2016 Defer Date: 08.03.2017 614

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

PHARMACEUTICALS LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01050/AM17/ RLA File :08/24/040/00319/AM17/ Lic.No/Date:0810139094 28.11.2016 Defer Date: 08.03.2017 615

Case No.:129/17/82-

ALC4/2016 Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01090/AM17/ RLA File :03/94/040/00675/AM17/ Lic.No/Date:0310809367 28.11.2016 Defer Date: 08.03.2017 616

Case No.:180/17/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01141/AM17/ RLA File :03/94/040/00689/AM17/ Lic.No/Date:0310809370 28.11.2016 Defer Date: 08.03.2017

101 617

Case No.:84/17/82-ALC4/2016 Party Name:MOREPEN

LABORATORIES LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01045/AM17/ RLA File :05/24/040/00415/AM17/ Lic.No/Date:0510400507 28.11.2016 Defer Date: 08.03.2017 618

Case No.:105/17/82-

ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01066/AM17/ RLA File :05/24/040/00414/AM17/ Lic.No/Date:0510400506 28.11.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/201/2016-PI(Norms) dated August 2016, 619

Case No.:137/17/82-

ALC4/2016 Party Name:ROYAL PHARMA Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01098/AM17/ RLA File :03/95/040/00633/AM17/ Lic.No/Date:0310809361 28.11.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/140/2016-PI(Norms) dated August 2016 for same export product , 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. 620

Case No.:163/17/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01124/AM17/ RLA File :03/94/040/00734/AM17/ Lic.No/Date:0310809399 29.11.2016 Defer Date: 08.03.2017 621

Case No.:164/17/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01125/AM17/ RLA File :03/94/040/00733/AM17/ Lic.No/Date:0310809398 29.11.2016 Defer Date: 08.03.2017 622

Case No.:165/17/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01126/AM17/ RLA File :03/94/040/00731/AM17/ Lic.No/Date:0310809396 29.11.2016 Defer Date: 08.03.2017

102 623

Case No.:106/17/82-

ALC4/2016 Party Name:PI INDUSTRIES LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01067/AM17/ RLA File :13/24/040/00033/AM17/ Lic.No/Date:1310048462 29.11.2016 Defer Date: 08.03.2017 624

Case No.:118/17/82-

ALC4/2016 Party Name:SUPREET CHEMICALS PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01079/AM17/ RLA File :52/24/040/00050/AM17/ Lic.No/Date:5210042073 29.11.2016 Defer Date: 08.03.2017 625

Case No.:139/17/82-

ALC4/2016 Party Name:ZIM LABORATORIES LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01100/AM17/ RLA File :03/95/040/00684/AM17/ Lic.No/Date:0310809406 29.11.2016 Defer Date: 08.03.2017 626

Case No.:151/17/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01112/AM17/ RLA File :03/95/040/00676/AM17/ Lic.No/Date:0310809433 30.11.2016 Defer Date: 08.03.2017 627

Case No.:67/17/82-ALC4/2016 Party Name:BALAJI AMINES

LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01028/AM17/ RLA File :31/83/040/00111/AM17/ Lic.No/Date:3110066418 01.12.2016 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.21/82 dated 06.02.2014, 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. 628

Case No.:85/17/82-ALC4/2016 Party Name:SENTISS

PHARMA PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01046/AM17/ RLA File :05/24/040/00416/AM17/ Lic.No/Date:0510400570 01.12.2016 Defer Date: 08.03.2017 629 Case No.:116/17/82- ALC4/2016 Party Name:AETHER INDUSTRIES LIMITED Meet No/Date:17/82- ALC4/2016 Status: Deferred

103 24.01.2017 HQ File :01/82/050/01077/AM17/ RLA File :52/24/040/00053/AM17/ Lic.No/Date:5210042078 02.12.2016 Defer Date: 08.03.2017 630

Case No.:133/17/82-

ALC4/2016 Party Name:AMINES & Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01094/AM17/ RLA File :03/94/040/00771/AM17/ Lic.No/Date:0310809551 02.12.2016 Defer Date: 08.03.2017 631

Case No.:117/17/82-

ALC4/2016 Party Name:ATUL BIOSCIENCE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01078/AM17/ RLA File :52/24/040/00051/AM17/ Lic.No/Date:5210042080 02.12.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/468/2014-PI(Norms) dated February 2015 for same export product , 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. 632

Case No.:132/17/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01093/AM17/ RLA File :03/94/040/00775/AM17/ Lic.No/Date:0310809552 02.12.2016 Defer Date: 08.03.2017 633

Case No.:97/17/82-ALC4/2016 Party Name:CADILA

HEALTHCARE LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01058/AM17/ RLA File :08/24/040/00324/AM17/ Lic.No/Date:0810139218 05.12.2016 Defer Date: 08.03.2017 634

Case No.:90/17/82-ALC4/2016 Party Name:CADILA

PHARMACEUTICALS LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01051/AM17/ RLA File :08/24/040/00327/AM17/ Lic.No/Date:0810139203 05.12.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION A-412. RA concerned may take further necessary action as per decision of NC. 635

Case No.:181/17/82-

ALC4/2016 Party Name:CENTAUR PHARMACEUTICALS PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred

104 HQ File :01/82/050/01142/AM17/ RLA File :03/94/040/00537/AM17/ Lic.No/Date:0310809606 05.12.2016 Defer Date: 08.03.2017 Decision : 636

Case No.:131/17/82-

ALC4/2016 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01092/AM17/ RLA File :03/94/040/00794/AM17/ Lic.No/Date:0310809604 05.12.2016 Defer Date: 08.03.2017 637

Case No.:128/17/82-

ALC4/2016 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01089/AM17/ RLA File :03/94/040/00801/AM17/ Lic.No/Date:0310809609 05.12.2016 Defer Date: 08.03.2017 638

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

CHEM-TECH LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01043/AM17/ RLA File :08/24/040/00318/AM17/ Lic.No/Date:0810139204 05.12.2016 Defer Date: 08.03.2017 639

Case No.:96/17/82-ALC4/2016 Party Name:CADILA

HEALTHCARE LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01057/AM17/ RLA File :08/24/040/00326/AM17/ Lic.No/Date:0810139221 06.12.2016 Defer Date: 08.03.2017 640

Case No.:78/17/82-ALC4/2016 Party Name:INDIA GLYCOLS

LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01039/AM17/ RLA File :05/23/040/00412/AM17/ Lic.No/Date:0510400608 06.12.2016 Defer Date: 08.03.2017 641

Case No.:135/17/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01096/AM17/ RLA File :03/95/040/00697/AM17/ Lic.No/Date:0310809629 06.12.2016 Defer Date: 08.03.2017 642 Case No.:167/17/82- Party Name:YASHO Meet No/Date:17/82- Status:

105 ALC4/2016 INDUSTRIES PVT.LTD. ALC4/2016 24.01.2017 Deferred HQ File :01/82/050/01128/AM17/ RLA File :03/95/040/00696/AM17/ Lic.No/Date:0310809628 06.12.2016 Defer Date: 08.03.2017 643

Case No.:79/17/82-ALC4/2016 Party Name:ABEERS

PHARMACEUTICALS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01040/AM17/ RLA File :05/23/040/00426/AM17/ Lic.No/Date:0510400659 07.12.2016 Defer Date: 08.03.2017 Decision : 644

Case No.:80/17/82-ALC4/2016 Party Name:ABEERS

PHARMACEUTICALS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01041/AM17/ RLA File :05/23/040/00424/AM17/ Lic.No/Date:0510400658 07.12.2016 Defer Date: 08.03.2017 645

Case No.:83/17/82-ALC4/2016 Party Name:INDO PHYTO

CHEMICALS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01044/AM17/ RLA File :05/23/040/00361/AM17/ Lic.No/Date:0510400646 07.12.2016 Defer Date: 08.03.2017 646

Case No.:174/17/82-

ALC4/2016 Party Name:INDOCO REMEDIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01135/AM17/ RLA File :03/94/040/00769/AM17/ Lic.No/Date:0310809668 07.12.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/353/2015-PI(Norms) dated 11.11.2015 for same 647

Case No.:175/17/82-

ALC4/2016 Party Name:INDOCO REMEDIES LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01136/AM17/ RLA File :03/94/040/00770/AM17/ Lic.No/Date:0310809669 07.12.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/522/2015-PI(Norms) dated 19.01.2016 for same 648 Case No.:126/17/82- ALC4/2016 Party Name:AMINES & Meet No/Date:17/82- ALC4/2016 Status: Deferred

106 24.01.2017 HQ File :01/82/050/01087/AM17/ RLA File :03/94/040/00803/AM17/ Lic.No/Date:0310809672 08.12.2016 Defer Date: 08.03.2017 649

Case No.:127/17/82-

ALC4/2016 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01088/AM17/ RLA File :03/94/040/00800/AM17/ Lic.No/Date:0310809684 08.12.2016 Defer Date: 08.03.2017 650

Case No.:81/17/82-ALC4/2016 Party Name:BIO TECH

OPHTHALMICS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01042/AM17/ RLA File :08/24/040/00360/AM17/ Lic.No/Date:0810139254 09.12.2016 Defer Date: 08.03.2017 651

Case No.:166/17/82-

ALC4/2016 DYE-CHEM PVT. LTD., Meet No/Date:17/82- ALC4/2016 24.01.2017 Status Approved HQ File :01/82/050/01127/AM17/ RLA File :03/95/040/00625/AM17/ Lic.No/Date:0310809714 09.12.2016 Defer Date: 652

Case No.:187/17/82-

ALC4/2016 Party Name:SRINI PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01148/AM17/ RLA File :09/24/040/00483/AM17/ Lic.No/Date:0910064463 09.12.2016 Defer Date: 08.03.2017 653

Case No.:148/17/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01109/AM17/ RLA File :03/95/040/00703/AM17/ Lic.No/Date:0310809708 09.12.2016 Defer Date: 08.03.2017 654

Case No.:158/17/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01119/AM17/ RLA File :03/95/040/00690/AM17/ Lic.No/Date:0310809727 09.12.2016 Defer Date: 08.03.2017

107 655

Case No.:159/17/82-

ALC4/2016 Party Name:UNIMAX LABORATORIES PVT.LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01120/AM17/ RLA File :03/95/040/00669/AM17/ Lic.No/Date:0310809709 09.12.2016 Defer Date: 08.03.2017 656

Case No.:134/17/82-

ALC4/2016 Party Name:UPL LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: approved HQ File :01/82/050/01095/AM17/ RLA File :03/95/040/00505/AM17/ Lic.No/Date:0310809711 09.12.2016 Defer Date: taken by NC in its meeting No.4/82 dated 16.05.2013, uploaded at the end of these minutes or as 657

Case No.:136/17/82-

ALC4/2016 Party Name:UPL LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01097/AM17/ RLA File :03/95/040/00417/AM17/ Lic.No/Date:0310809721 09.12.2016 Defer Date: taken by NC in its meeting No.23/82 dated 01.11.2012, uploaded at the end of these minutes or 658

Case No.:107/17/82-

ALC4/2016 Party Name:AMANTA HEALTHCARE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01068/AM17/ RLA File :08/24/040/00361/AM17/ Lic.No/Date:0810139255 13.12.2016 Defer Date: 08.03.2017 659

Case No.:178/17/82-

ALC4/2016 Party Name:AMINES & Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01139/AM17/ RLA File :03/94/040/00804/AM17/ Lic.No/Date:0310809744 13.12.2016 Defer Date: 08.03.2017 660

Case No.:146/17/82-

ALC4/2016 Party Name:CIPLA LIMITED. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01107/AM17/ RLA File :03/94/040/00835/AM17/ Lic.No/Date:0310809781 13.12.2016 Defer Date: 08.03.2017

108 661

Case No.:144/17/82-

ALC4/2016 Party Name:ENALTEC LABS PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01105/AM17/ RLA File :03/94/040/00824/AM17/ Lic.No/Date:0310809771 13.12.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/487/2012-PI(Norms) dated 14 November 2012, 662

Case No.:145/17/82-

ALC4/2016 Party Name:FERMENTA BIOTECH LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/01106/AM17/ RLA File :03/94/040/00817/AM17/ Lic.No/Date:0310809743 13.12.2016 Defer Date: Decision : The Committee decided to ratify norms based on the earlier recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/577/2015-PI(Norms) dated December 2015, 663

Case No.:173/17/82-

ALC4/2016 Party Name:HARMONY LIFESCIENCE PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01134/AM17/ RLA File :03/94/040/00815/AM17/ Lic.No/Date:0310809753 13.12.2016 Defer Date: 08.03.2017 664

Case No.:142/17/82-

ALC4/2016 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01103/AM17/ RLA File :03/94/040/00818/AM17/ Lic.No/Date:0310809757 13.12.2016 Defer Date: 08.03.2017 665

Case No.:143/17/82-

ALC4/2016 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01104/AM17/ RLA File :03/94/040/00819/AM17/ Lic.No/Date:0310809758 13.12.2016 Defer Date: 08.03.2017 666

Case No.:160/17/82-

ALC4/2016 Party Name:SIRMAXO CHEMICALS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01121/AM17/ RLA File :03/95/040/00492/AM17/ Lic.No/Date:0310809770 13.12.2016 Defer Date: 08.03.2017

109 667

Case No.:156/17/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01117/AM17/ RLA File :03/95/040/00718/AM17/ Lic.No/Date:0310809765 13.12.2016 Defer Date: 08.03.2017 668

Case No.:157/17/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01118/AM17/ RLA File :03/95/040/00719/AM17/ Lic.No/Date:0310809768 13.12.2016 Defer Date: 08.03.2017 669

Case No.:153/17/82-

ALC4/2016 Party Name:PALADIN PAINTS AND CHEMICALS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01114/AM17/ RLA File :03/95/040/00699/AM17/ Lic.No/Date:0310809824 14.12.2016 Defer Date: 08.03.2017 670

Case No.:147/17/82-

ALC4/2016 Party Name:S M CHEMICAL VAPI PRIVATE LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01108/AM17/ RLA File :03/95/040/00659/AM17/ Lic.No/Date:0310809834 14.12.2016 Defer Date: 08.03.2017 671

Case No.:213/17/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01174/AM17/ RLA File :08/24/040/00321/AM17/ Lic.No/Date:0810139295 15.12.2016 Defer Date: 08.03.2017 672

Case No.:177/17/82-

ALC4/2016 Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01138/AM17/ RLA File :03/94/040/00845/AM17/ Lic.No/Date:0310809853 15.12.2016 Defer Date: 08.03.2017 673

Case No.:119/17/82-

ALC4/2016 Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved

110 HQ File :01/82/050/01080/AM17/ RLA File :31/83/040/00118/AM17/ Lic.No/Date:3110066465 15.12.2016 Defer Date: Decision : The Committee decided to ratify norms based on the earlier recommendation forwarded vide U.O.No.14010/3/2012-Ch-II dated 16.02.2016, 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 674

Case No.:176/17/82-

ALC4/2016 Party Name:GITANJALI CHEMICALS PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01137/AM17/ RLA File :03/94/040/00741/AM17/ Lic.No/Date:0310809851 15.12.2016 Defer Date: 08.03.2017 675

Case No.:149/17/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01110/AM17/ RLA File :03/95/040/00721/AM17/ Lic.No/Date:0310809874 15.12.2016 Defer Date: 08.03.2017 676

Case No.:150/17/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01111/AM17/ RLA File :03/95/040/00722/AM17/ Lic.No/Date:0310809877 15.12.2016 Defer Date: 08.03.2017 677

Case No.:152/17/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File :01/82/050/01113/AM17/ RLA File :03/95/040/00724/AM17/ Lic.No/Date:0310809913 15.12.2016 Defer Date: 08.03.2017 678

Case No.:3/17/82-ALC4/2016

Party Name:HONOUR LAB LIMITED Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Approved HQ File :01/82/050/00964/AM17/ RLA File :09/24/040/00521/AM17/ Lic.No/Date:0910064504 22.12.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/582/2014-PI(Norms) dated May 2015 for same 679

Case No.:154/17/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:17/82- ALC4/2016 24.01.2017 Status: Deferred HQ File RLA File Lic.No/Date:0310810059 Defer Date:

111 :01/82/050/01115/AM17/ :03/95/040/00748/AM17/ 22.12.2016 08.03.2017 Decision :Deferred.

⌒ lmport ltem 1,4 Butanediol 0.512 kg Ethyl Alcohol (95% Minimum) 180 RA may takc neceSSary actlon as pcr the decision ofNorms COmnnittec. ● | l Export Product 賄 ｏ ‐ ｖ ． S.No Qty. aHo、ved/kg N― Ethyl-2- D■′rr^1:パハnρ l kg 1 0 882 kg ・ ′・・ つ ４ Ammonia AnhYdrous 0.176 kg 3. 4. trthvlamine Catalvst 0.001 kg

_* elt F. No.350 1 1 16801201 5-Pl (Norms) Government of lndia Ministry of Chemical & Fertilizers Department of Pharmaceuticals Udyog Bhawan, New Delhi, Dated: 29 March ,2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14

Case of M/s Naprod Life Sciences Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182150i1065/AM- 14IDES-3/897 dated the 719115 vide which application from M/s Naprod Life Sciences Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Hydrocortisone Sodium Succinate. 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 Hvdrocortisone 0.88kq 2 This issues with the approval of competent authority. (Rajkumar) Under Secretary to the Government of lndia PH.- 23071162 Directorate General of Foreign Trade, Department of Commerce, (Shri M.V. Singh, FTDO), Udyog Bhawan, New Delhi

,31/82 dated 21.2.2013,it J 協 ⌒ 50 lcase No.:62ノ4/82‐ ALC4/2013 Party Name:UNITED PHOSPHORUS LTD. :01/82/050/00103/AM14/ sion:In the light of decided to ratlfy noロ |△月k.7+hO■rtn、■ 7hin} earlier decision ta ms under Para 4.7 rever is less: en ln meetlng nO' Jll6z (Ialsu Lr'L'LvLr' LL rf HBP vl as per details given below or as Import Product Quantity A1loヽved Export Product Export OuantitY S,No Phenol 0.666 kg Phenyl Chloroformate l kg 1 2. 而 bne DたЫoH色 0.292 kg RA mりtttc approp五江ea“ on aspcr ic dcddon ofNoms CommmcQ

^ へ ′θ ICase No.:43/28/82-ALC4/2012 Parw Nallle:METROPOLITAN EXIMCHEM LTD Mcct No/Date:5/82- :ALC42013 130052013 :Lic No/Date:0310713820 1DeferDate: :Decision::11l thc ligll1 0f written collllnCnts receivcd fl・om Dcpartmcnt ofChemicals andl ,Pctrochenlicals vide their l」.O No. 14010/60/2010-Ch.II dated 26_08.2012,it was decided ‐ rclrocnenllcais vlcle thelr∪.o No.14010/60/2010-Ch.II dated 26_08.2012,it was decidedi ltO ratitt nOrllls under Para 4.7 of HBP vl as per details g市 en be10w Or as applicd by the: |■rnl、whichever is iess: ‐ RA nlay take appropriate actiOn as per the decision ofNornls Colnl■littce。 ,HQ File :01/82/050ノ01010/AM13/ IRLA File 103/95/040/00561/AM13/ Export Quantity MR-3 (2′ 4′ 6-丁RI[(2′ 4- DIHYDROXY 3-MEttHYL) pHFNVL]1,3′ 5-丁RIAZINE 2 - Methyl Resorcinol Cyanuric Chloride Export Product S.No Import Product Quantity allowed l kg 1.140 kg 2. 0 479 kg う Ｄ Sulfolane 1 800 kg

[行 IS No:4/20/82‐ ALC4/2011 IRLA File lLic No/Date:0310645547 103/95/040/00338/AM12/ 101 082011 Decision : Committee considered case as per agenda and in light of written comments fonruarded by Department of C&PC vide their U.O. No.140'10/9/2003-Ch.lll dated 28.05.2007 and in consultation technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per below or as applied by firm whichever is lower:- RA concerned may take further necessary action as per above decision of NC.

. Committee considered case as per agenda and in light of earlier decision taken in 40/82 held on 04.01.2011 and in consultation with technical authorities present in meeting, to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is Export product Exp. Qty. SI No lmport items Qty. allowed Dehydro Thio-Para Toluidine Sulfonic Acid l Kg Para Toluidine 1 852 kg concerned may take further necessary action as per above decision of NC. ‐ ICase No!46/10/82- IParty NameiGOLD STAR IMeet No/Datei1 4/82- iStatusiCase | :ALC4/2011 1CHEMICALS PVT LTD IALC4/2011 :Approved l l l 105 07 2011 1 1鴨脱:j:::鳳話j l胤温j::: L`雨″ biよё Jb6036百01 94/AM12/ i26052011 1

|ン 一´lq`

Case No.:148/10/82- Pa“y Name:ANTHEA IMeet No/Date:24/82‐ Status:Case

へLC4/2013 1AROMATICS PVT LTD, :ALC4/2013 1Approved 127032014 1 HQ File lRLA File lLic No/Date:0310730232 1Defer Date: 101/82/050/00331/AM14/ 103/94/040/00996/AM13/ 103042013 1 Decision:ln the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No.14010/35/2012-Ch‖ dated 14.03.2014′ it was decided to ratify norms under Para 4.7 of HBP vl as per detalis given below or as apphed by the firm′ whicheveris less: Export product ExpOrt Qtv SI No lmport item Qty. allowed BOISAMBER MIN.PURITY 990/0 l Kg CYCLODODECANOL ⅣIIN.PURITY 95% 0 950 kg 2 DIETHOXYⅣIETHANE MIN.PURITY 99% 1 0 kg RA concerned may take further necessary action as per above decision of NC.

1電トロー ｀τ 2′ | | :Casc No.:25/4/82‐ ‐AL(:4/2014 :HQ nite ,nLe pile ilic.No/Date:0410151914 Defer Date: :01182/050/00273/AMl5/ 104/241040100176lAMl4l l4ll.20l3 INTERMEDIATES P LTD :ALC4/2014 20102014 Decision : ln the light of written comments received from Department of ChemicrtrcnJ | IPetrOchemicals vide their∪ .O No. 14010/41/2012-Ch ll dated 19 08 2014′ it was decided tol 1143 raJfy norms under Para 4.7 of HBP vl as per details given below or as applied by the nrm′ | l whicheveris less: 瞭‖勝 AN MEⅢ…¬鰍g「 INI%矛N F雌里_JI RA may take appropnate actlon as perthe dec`ion of Norms Commに tee, | Export product Exp. Qty. SI No lmport items Qty. allowed D‐TRYPTOPHAN METHYL ESTER HCL PURITY‐ 99°/0 1 D―TRYPTOPHAN PURITY‐ 99% 0 944 kg

⌒ : Committee considered case as per agenda and in light of written comments forwarded by of C&PC vide their U O No 14010/106/2011-Ch ll dated 04 10 201l and in consultation technical authority present in meeting, decided to ratify norms as per details below or as applied the firm whichever is lower:-

Case No:10/26/82-

ALC4/2011 No/Datei031 0642433 15072011 Export product I Exo. Qtv. SI No lmport items Qtv a!!owed Anethole (Pure) l Kg Benzene, 1-Methoxy-4-(1-Propenyl)- (E) 1.03 kg

|ト フЧ I Case No.:2/1/82- Party NamclGEM IMcct No/Datc:1/82‐ IStatus:Case l lALC4/2014 1AROMATICS PVT LTD :ALC4/2014 1Approved i 10012014 1 1 lt'('42('1■ | | : IHQ Filc lRLA Filc :Lic No/Datc:03107614951Dcfcr Datc: | : 101/82/050/00002/AM 15/ :03/94/040/00771/Aヽ 414/ 111 122013 1 1 1 1Decislon:ln the light of wntten cOmments received from Department of Chemicals andi l PetrOChemicaヒvide their u O No 14010/65/2010-Ch‖ dated 21 04 2014′ t was decided to: 18■raufy nOrms under Para 4.7 of HBP vl as per details g市 en below or as applied by the nrm′ : | lwhichever is less: 10012014 : IHQ Filc lRLA Filc : IHQ Filc iRLA Filc :Lic No/Datc:03107614951Dcfcr Datc: : 101/82/050/00002/AM 15/ :03/94/040/00771/Aヽ 414/ 111 122013 1 | IDecislon:ln the light of wntten cOmments received from Department of Chemicals andi l lPetrOchemicals vide their U O No 14010/65/2010-Ch il dated 21 04 2014′ it was decided to: 18■raufy nOrms under Para 4.7 of HBP vl as per details g市 en below or as applied by the nrm′ : | lwhichever is less: | | | : RA may take appropnate actlon as perthe decision of Norms Commttee l | : I ExpOrt product l Exp.Qty l SI No llmporttems l Qty allowed l Export product Exp, Qty. SI No lmport items Qty. allowed EUGENOL CLOVE LEAF OIL (EUGENOL CONTENT 77ツA十/-49るヽ 1 31 kg

毎Ъ′ ノ Ｆ Ｉ =癬 Йれが~埒魁 |二l準桜 「 面:警癬 IHQ File lRLA File Lic.No/Date:0310736969 :Defer Date: :01/82/050/00723/AM14/ 1:03/94/040/00178/AM14/ 106062013 1 1)ecision : ln the nght of written comments received from Department of Chemicals and Petrochemicals vide their U.O No.14010/100/2012-Ch ll dated 12.11.2013′ lt was decided to lratify nOrms under Para 4.7 of HBP vl as per detalls g市 en below or as applied by the irm′ vvhichever is less: Export Product Export Quantity S.No lmport Product Quantity Allowed DIPHENYL ISODECYL PHOSPHITE l kg PHENOL 0 558 kg 2. ISODECYL ALCOHOL 0.419 kg 3 YELLOW PHOSPHORUS 0.09 kg may take appropriate action as per the decision of Norms Committee.

F. No.350 I I I l8l /201 5-PI (irtrorms) Government of India Ministry of Chemicals & Fertilizers Udyog Bhawan,New Delhi, Datedthe September,20l5 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 200g-l4Case of

M/s Astrix Labs Ltd. The undersigned is directed to refer to DGFT U.o.No. 01182/s0/100g/AM-15/DES-3/1303 dated the 05/03/15 vide which application from M/s. Astrix Labs Ltd was sent to this o.purt..nt for fixation of norms under para: 4.7 for the export of Emtricitahine. This department has examined the matter and the following nonns are furnished under para 4.7 or Hana Book of Procedures (Vol.1) 2009 -1 4:- Under Secretary to the o.9rffi:'rffiil?1? Phone:23071162 (Shd M.V. Singh, FTDO), 才 Qty. Recommended kg/kg. R,5 S)-5 -(4-Amino-5 -Fluoro-2-Oxo-2H-pyrimidin_ I -yl)-[1,3]-Oxathiolane-2-Carboxylic Acid, 2S- l-5R-Methyl- I R-Cyclohexyl Ester (FCE) ium Borohydride ium Hydrogen Phosphate ethylene Chloride Not an lnputin the prOcess.

^ |:)…… 多｀ 1

Case No.:59/lll82-ALC4/20I2,Party Name:JINDAL DRUGS

RA may take appropriate action as per the decision of Norms Committee. Mcct No/Date:24/82‐ ALC4/2012 15 11.2012 Lic No/Datc:0310697012 31052012 Decision : In the light of written comments received fiorn Department of Chemicals and Petrochemicals vide their U.O No. 1401011061201 l-Ch. II dated 26.10.2012, it was decided ratify norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less: .l Status:Case I iApproved , Export Product Export Qty. SI No lmport items ｄ 叫 ａ ‐ ‐ 。 ｗ ｅ ｋ ｇ ／ ｋ ｇ Pure Cineole l kg Eucalyptol Oil 105

^ )ト 多″ ICase No:8/44/82-ALC4/2009 ,Party Name:EMAMI LIMI丁 ED,,Meet No/Datei8/82- IStatusiCase ‐ALC4/2011 :Approved ` , 124052011 : IHQ File lRLA File lLic No/Datei021 01 36503 1 101/82/050/00893/AM10/ 102/24/040/00173/AM10/ 14012010 1 Dedsion i Commtttee considered case as per agenda and in loht Of Wntten cOmments fowarded by lDC(MSME)vide their U O No 23(4)/2011-Chem dated 26 05 201l and in consuhalon wnh technical lauthority present in meeting, decided to ratify norms under para 4 7 of HBP as per deta‖ s below or as ,applied by firm whicheveris loweri― Export Product Export Qtv. SI No lmport items Qtv. allowed Himani(Fast Relief) Pain Relief Ointment (HFRO) l KG Liqht!lquid Paraffin Wax 0 117 kq 2 Micro Crystalline Wax Melting Point 75-80 C 0120k9 3 Paraffin Wax (Hard Paraffin) 0 110 kg 4 Ozokirte Wax 0 090 kq 5 Methvl Salysilate Winter Green Oil 0 200 kq 6 Polypropylene Gran ules (l njection Moulding Grade) or PP Caps ９ 阿 ｃ ｋ ｉ ｎ ‐ ｉ ｃ ｖ Ａ ｓ ｐ ａ ｏ 。 RA concerned may take further necessary action as per above decision of NC. 18

ヘ 11)…… ′

Case No.:36′ 46′82‐ALC4′2011

HQ File i01/82/050/01252/AM12/ Patty Name:ALttA LABORATORIES LttD et No/Date:10/82- C4/2012 062012 艦脇:1誌濡 ~~1よ 濡雷面ド師 : | 152 Decision: Commlttee considered case as ler agenda and in light of w‖ tten comments forwarded by Deptt of C&PC vlde thel「 U O No 14010/37/2012-Ch‖ dated 25 05 2012 and in consultation with the technical authonties present in the meeting decided to ratify norms under para 4 7 of HBP as per details below or as applied by firm whicheveris lower― Export product 恥 叫 S:No lmport items Qty. allowed Propyl Paraben l kg 1 Para Hydroxy Benzolc Acid 0 850 kg 2 N-Propanol 0 500 kg RA concerned may take further necessary action as per above decision of NC

場 F. No.3501 1/1/20 16-Pl (Norms) Government of lndia Dated: 1 June,2016 Office Memorandum Case of M/s Suven Life Sciences Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/0 i 85/AM- '16/DES-3/1653 dated the 18/2/16 vide which application from t\ills Suven Life Sciences Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of (l-Phenylmethyl)-lH-lndeno[2,1-b]Pyridine-6-Carbonitrile. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- DGFT is advised to callfollowing details from the firm viz:-

  1. The import item is catalyst only for which no recovery or regeneration is shown. The firm may be advised to elaborate the recovery of imported catalyst with technical justification.

(Ralkumar) Unde「Secretary to the Government Oflndia PH 23071162 (Shri lvl.V. Singh, FTDO),

⌒ 11)―― 屯ζ l鷺rlZ:] Чg′ 59 CaseNo.:72l46/82-ALC4l2Oll rParty Name:NEW ALLIANCE MeetNoiDate:46182- ALC4/20H 114022012 11:ハヽIA/n01 IRLA Flle Li( :03/95/040/00830/AⅣl12/ 109 Decision : Committee considered case as per agenda and in light written comments received from of Chemicals and Petrochenlicals vide their U O No 14010/83/2010/Ch il dated .11.2010 and in consultation with technicalauthority present in meeting, decided to ratify norms

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. IDYE―CHEM PVT LTD, Lic No/Date:0310675523 012012 :01/82/050/01288/AM12/ Exoort oroduct Exp. Qtv. SI No lmport items Qtv. allowed Disodium LDIA ∠inc (∠n Content 15%(+/-0.5%) l kg Ethylene Diamine Tetra Acetic Acid (EDTA) 0 690 kg

^ 42_ 1~い 薫薫=違 菊面]/2013~Pa13/而孫まlNDO‐AM｀ES~lMeざ馬7面ifiラ思うI~冨稿高 : : : LIMITED :ALC42013 1Approved i 105 12.20:3 1 : IHQ百お~
■LA Fhざ ~ il「 、ス,記法.ムヽlAうル(葛■ふIIKII: 105 12.20:3 1 : 由ご｀ルDa庭:bj16ライ43勇 :De花F5屁ぎ : ::マl HC 101/82/050/00629/AM14/ :ur/6 //u)u/0u621)/AMr4r :03/94/040/00322/AMr4r 07.0g.2013 ' D..i.ion , r" the right of written .orr"rt, ,.ecerueJ rr., o"prrt*"ri ;i il;i;;ri-."J I ^--- , 'Petrochemicals vide their U.o No. 14010/81/2010-ch il dated 21,.11,.2013, it was decided to 94 ratify norms under Para 4-7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Qty. SI No lmport items Qtv. allowed 1-Methyl Cyclohexene l KG Ortho Cresol 1 25 kg RA conce「ned may take further necessary actiOn as per abOve decisiOn Of NC

⌒ |:)…… ■1研~ No.:58/49/82- ALC4/2011 Pany Name:CROWN ICHEMICALS PVT.LTD, IMcet No/Datc:49/82- ALC4/2011 106.03.2012 し8:湿あ五百6bio68碑諾DeferE滋ざ 106.02.2012 1 RLA Filc :03/94/040/00968/AM12/ RA may take appropriate action as per the decision of Norms Committee. :01/82/050/O1367/A》ッ112/ : Committee considered case as per agenda and in light of written comments received from of Chelllicals and Petrochenlicals vidc their U.C)No 14010/175/2012 Ch. II dated .2.2012 and in consultation with technical authority present in meeting decided to ratify norms para4.7 of HBP as per details below or as applied by firm whichever is lower:- Catechol (Minimum Purity 99o ) IHQ Filc Export Product Export Otv. Sl.No. Import items Qty. allowed Piperonal Min. Purity 98% l kg 1 0.862 kg ０ ４ Dichloromethane rMin.Puritv 990/0) 0.703 kg Dimethvlsulfo対de(Min.Pu面ty 99%) 4 Hcxamine(Min Puritv 960/0) 1.000 kg Toluene rMin.Puritv 97° /0) 0.430 kg 6. IsooroovI AIcohol rMin,Puritv 990/0) 0.220 kg

い Ｖ ヘ Status:Case Approved : IHQ F‖ e lRLA File lLic No/Date:0310534431 1:01/82/050/00579/ノヽM10/ ::03/95/040/00307/AM10/ 120082009 犯 ｎ ｉ ｃ ａ ‐ ｗ 。 ｒ ｉ ｎ ３ ｔ ｅ ｃ ｈ ｂ ｅ ‐ 。

Case No:9/29/82-ALC4/2009 1Party NameiPRIVI

10RGANICS LTD ALC4/2011 cision . Committee considered case as per agenda and in light of earlier decision taken in 34/ eting held on 17.11.2009 and meeting held on 16.11.2010 and in consultation with techni, :horiiy present in meeting, decided to ratify norms under para 4.7 of HBP as per details below applied by firm whichever is lower:- Export product Exp Qtv SI No lmport items Qty. allowed Amber Fleur (2,3,8,8- Tetramethyl 1,2,3,4,5,6,7,8- Octohyd ro-2-Naptha lenyl Methyl Ketone l Kg Myrcene 80% 1 00 kg 2 Methyl巨thyl Ketone 0 600 kg 3 Toluene 0 02 kq 4 Phosphoric Acid 0150k9

⌒

  • --, c"," N'; olis;82-Al i'i' rtiiii ;g$lf-Utlg." ALC4/2012 1.112012 IR-e *uy ture appropriate actton 99TTⅢ '7 MggIヽЪ′ Dttc:23/82‐ 11∋…" Lぼぢ 9`′F7 Approved lmpoはlems %ito-w PnosPhorous ilrri DecYl ohol(TH Decyl

ケ F. No.350I I126612015-PI (Norms) Government of India Udyog Bhawan,New Delhi, Dated thc OctOber,2015 Office Memorandum

Subject: - Fixation of norms under paru 4.7 of Hand Book of Procedures (Vol.l) 2OOg-14 Case of

M/s Mylan Labs Ltd. The undersigned is directed to refer to DGFT U.o.No. ollg2lsolll4lAM-|6:DES-3/56 dated the 12106115 vide which application from M/s. Mylan Labs Ltd was sent to this Department for fixation of norms under para:4.7 for the export of Montelukast Sodium. This department has examined the matter and the following norns are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009 -l 4- S.No. Import Item 1 2-(2-3(S)-(3 -(2-(7 -Chloro-2-quinolinyl)-ethenyl)phenyl)-3 - hydroxypropyl)phenyl-2-propanol 1.24 2. 2-[ l -(Mercaptomethyl)cyclopropyl]acetic acid 0.40 3. L(十)Tartaric acid 0.643 4. N, N-Di isopropyl ethylamine 0.30 ξ υ Acetonitrile 4.56 6. lsopropyl ether 0.114 7. -methyl-2-pyrrol idone Not shown in RXN ０ ０ n-Heptane つ ４ 9. Ioluene 3.19 10. Hexane 8.65 Dichloromethane 6.14 つ ４ Acetone 1.37 13. \4ethanol 2.50 (Barnali Khastgir) Under Secretary to the Government of India Phone:23071162 Directorate Gcneral of Forcign Trade, Dcpartmcnt of COnllncrce, (Shri NII.Vo Singh,FTDO), Udyog Bhawan,Ncw Delhi

⌒ 60 i銭 腸 F/54/82-「 w、 DYE― 嘱 :鮮 日 憫2平 腑 ∞ HQ File lRLA FIle Lic No/Datei311 00471 88: i01/82/050/01748/AMl1/ 131/24/040/00263/AMl1/ 103032011 1 1Decision: Committee considered case as per agenda and in light of written comments fon〃arded by Department of C&PC vide their U O No 14010/55/2004 Ch‖ dated 08 02 2010 and in consultation ‐with technical authority present in meeting, decided to revise norms under para 4 7 of HBP as per detalls below or as applied by lrm whicheveris lowe「― Export oroduct Exo. Qtv. SI No lmport items Qty. allowed Sodium Saccharin (Dental Grade) l kg 1 lnsoluble Saccharin 0 789 kg

^ | 147

Case No i27/47/82-

ALC4/2010 IParty Name:RR」 DYES& IMeet No/Date:3/82- lStatusiCase lNTERMEDIATES LttD IALC4/2011 lApproved . 119042011 1 HQ File ‐RLA File Lic No/Datei0810095587 1 :01/82/050/01617/AMl1/ 1:08/24/040/00307/AMl1/ 19012011 1 Decision:Committee considered case as per agenda and in light of written comments fon″ arded by Department of C&PC vide their U O No 14010/60/2008-Ch‖ l dated 08 11 2010 and in consultation with technical authorities present in meeting, decided to ratify norms under para 4 7 of HBP as per detalls below or as applied by firm whicheveris loweri‐ Export product Exp. Qty. SI No lmport items Qtv allowed Dehydro Thio-Para Toluidine Sulfonic Acid l Kg Para Toluidine 1 852 kg

′ト 一59 1常ぶ濡鳥9酔: 1監:漱Tttたメ :LIMITED、 125092014 RLA File :Lic No/Date:0710103554 1Dcfcr :07/24/040/00473/AM14/ 110042014 'Datcl12 11 2014 ICase No.:157/6/82- :ALC4/2014 :HQ Fllc :01/82/050/00559/Aヽ415/ IDecislon:in the light of wrtten comments received from Department of Chemicals and Petrochemicals vide their U.O No 14010/56/2011‐ Ch.‖ dated 09 10.2014,t was decided to lratify norms under Para 47 of HBP vl as per detaiL g■ en below or as applied by the lrm′ whicheveris iess: Export product Exp Qtv. SI No. lmport items Qty. allowed Calcium Citrate l kg 1 Citrlc Acid 0 816 kg 2 Calcium Carbonate 0 708 kg Magnesium Citrate l kg 1 Citnc Acid 1 001 kg Magnesium Carbonate 0 730 kg Potassium Citrate l kg Citnc Acid 0.859 kg Zinc Citrate l kg Citric Acid 0 880 kg RA may take appropriate action as per the decision of Norms Committee.

|::トー Meet No/Date:7/82- IHQ File lRLA File lLic.No/Datei05 10347436 :O1/82/050/01431/AM13/ 1:05/23/040/004681AM 13/ 126.02.2013 i;i;; t In the light of written comments received from Department of Chemicals and ochemicals vide their U.O No. l4}l)l38l20l l-Ch II dated 15.4.2013, it was decided ratify norms under Para 4.7 of HBP vl as per details given below or as applied by the whichever is less: RA -uy take appropriate action as per the decision of Norms Committee. Party Name:JUBILANT LIFE SCIENCES LIMITED ALC4/2013 27.062013 Import items Alumino Silicate Catalyst 4-(Dimethyl Amino)― Pyridine Denatured Ethyl Alcohol Dimethyl Formamide 11 つ ‘ | Export product ■ 帥 Ｑ ｔ ｙ ． Sl.No. Qty. allowed l kg 0.0436 kg 2. 5.34 kg 3. Methanol 3.22 kg 4. Thionyl Chloride 4.14 kg 5. 1.00 kg 6. Toluene 2.00 kg

|つ´ ` |

Case No.:5/49/82- ,Pany Name:SPAK :Mcct No/Date:49/82-

ALC4/2011 :ORGOCHEM(INDIA)PVT.:ALC4/20H :LTD. 06.032012 HQ F‖c lRLA File :Lic.No/Date:0310683338 :01/82/050/01314/AM12/ ::03/95/040/00862/AM12/ 124.02.2012 ｅ ａ ． ｄ “ ｏ ｖ ｅ Ｓ ｔ ａ ｔ ｕ 柳 Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting no.53/82 dated29.6.2009 and in consultation with technical authority present in meeting, decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Exp Otv Sl.No. Import items Qty. allowed Sorbitan Mono Stearate l Kg. 1 Sorbito1 700/O Solution 0.470 kg う ４ Stearic Acid 0.634 kg RA concemed may take further necessary action as per above decision of NC.

\1 F. No.3501 Il74t20ts-PI (Norms) 6 Government of India Udyog Bhawan,New Delhi, Datedthe September,20l5 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of

M/s Biological E. Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501935/AM-15/DES-3/1107 dated the l9l0ll15 vide which application from M/s. Biological E. Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Noscapine. 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 Product Noscapine (BP/USP/JP)----------------- I kg Import Recommended Noscapine Crude Content 98.5% .05kg/kg Crude: Purity 98.5% (Barnali Khastgir) Phone:23071162 lu, \12

才 Subi F. No.350 l 1 157 612014-PI (Norms) Government of India ' Udyog Bhawan, New Delhi, the April,20l5 Office Memorandum Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s. Vivimed Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011128,531 ,1125lAM121DES-3/784 dated the 29110114 vide which an application from M/s. Vivimed Labs Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Triclosan Oral Grade. This department has examined the matter,in line with the Central Excise Certificate furnished by the frim certifoing import of only 4 Inputs and the following comments are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- 2. DGFT is also advised to revise the SION 4-2517 for Export of Triclosan Oral Grade of specified specifications as under:- 6. This issues with the approval of Director (PI). (Barnali Khastgir) Phone- 23071162 ,4 Dichloro Phenol ,5-Dichloro Nitro Benzene um Hydroxide Ethylene Mixed- Xylene Hydroxide /Caustic Soda S. No. Import Item 1 2,4 Dichloro Phenol 1.80 kg/kg 2. Perchloro Ethylene 3.00" Sodium Nitritc 0.63 " 4. Isopropyl Alcohol or Hexane 3.00"

身 じ F. No.3501 1/61 7 12015-Pl (Norms) Government of lndia Dated: 21 March, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2OO9-14

Case of M/s Globe Trotters Pvt. Ltd. The undersigned is directed to referto DGFT U.O.No. 01lB2tSOl737tAM-16/DES- 3/81 1 dated the 2018/15 vide which application from M/s Globe Trotters pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Rifampicin syrup/suspension. This department has examined the matter and the following norms are furnished under para 4.7 ot Hand Book of Procedures (Vol.l) 2009-14:- DGFT is advised to call following details from the firm viz:- 1 . Size fo the bottles to be exported/volume of syrup. 2. Copy of master-batch formula duly certified by e.C. incharge. 2. (Rajkumar) PH:- 23071162

:01/82/050ノ01186/AM12/ ICase No.:9′ 45′82‐ALC4′ 2011 Party Name:GLOBAL CALCIUM Calcium D Pantotheonate- Powder |,トーー 一1レ No/Date11 0/82- )No/Datei071 0084836 122011 RLA File i07/24/040/00373/AM12/ Decision : bommittee consioeied Cise ii per agenda and in light of written comments torwiioeo bt Depii of c&pc vide their U.o.No. 14010t56t2011-Ch.lt dated 29.05.2012 and in consultation with the technical present in the meeting decided to ratify norms under para 4.7 of HBP as per details below or as by firm whichever is lower:- Qty. allowed ssary action as per above decision of NC Export product 恥 Ｑ ｔ ｙ SI No lmport items l kg Calcium D Pantotheonate- Granular 1 025 kg

虐 一 予 ,ト ´ヽ F ・ Fで、 vide their U O No.14010/56/2011-Ch ‖dated 19 07.2014′ it was decided to: ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, ichever is less: ・ 　 ０ Ｓ ‐ Ｎ Export product Exp Qtv. lmport items Qty. Allowed MAGIIESIUM OROTATE OROTIC ACID 1 104 kg CALCIUM OROTATE OROTIC ACID 1059 3 POTASSILIM OROTATE OROTIC ACID 4 ZINC OROTATE OROTIC ACID FERROUS OROTATE OROTIC ACID 0 976 kg | :Case No.:25/5/82-ALC4/2014 Party Namc:GLOBAL CALCIUM PRIVATE :ALC4/2014 LIMITED 25 09 2014 IRA may take appropriate action as perthe decision of Norms Committee

ハ ⌒ 8ト 24.07.20t 5 : : ' . . '". . .: llQ File RLA File :Lic.No/DitJ,oiLo:siT% ffiffi"t* *, ::01/82/050100039/AM l6l i:0523/04000262tAMtst r s.o9l0 ia ' ' :-'' i ....-......-.. , ' :

Case No.:9/3/82-ALC4/2015 Party Nallle:INDO PHYTO Mcet No/Datc:7/82- statlls:Casc:

CHEMICALS PVTl_TD AL′ C4/2015 Appl・oved l HQ Filc : 24072015 Decision:丁he committee decided tO ratify the norms based on the recOmmendation of Department of Pharmaceuticals vide letter No.35011/ 333/2014-pt (Norms) dt. 1-4th August 2015 as per details g市en below Or as applied by the irm whicheverislessl― l11lo,t product Oty Inrport iterns Qty kg/kg 1 9-Norandrostenedione 99oZlntermediate σ ０ ‐ ´ ヽ 1 SITOLACTONE 140 ９ 一 CHLOROKET,(2、(3- Chlo■oprOpyl)-2,5,5- Trilllcthyl-1,3-Dioxane 130 TETRAHYDROFURAN 350 RA may take further action accordingly. 221 ， ト

17 .-'- '4, 5\ ,/ F. No.350l l162/2015-PI (Norms) Government of India Udyog Bhawan,New Delhi, Dated 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 Sun

Pharma Industries Ltd. The undersigned is directed to refer to DGFT U.O.No. 0ll82l50l1167lAM-l5|DES-3/1108 dated the l9l01/15 vide which application from M/s. Sun Pharma Industries Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Azelastine Hydrochloride Nasal Solution (Nasal Spray). This department has examined the matter and the following norrns are furnished under para4.7 of Hand Book of Procedures (Vol.l) 2009-14:- Export Item No.l Azelastine Hcl Nasal Solution (Nasal Spray) 0.1% (l37mcg per spray) 200 MD-----------1No' S. No. Imports Proposed Qty. Recommended. l Azelastine Hcl 28.77mg/vial つ ４ l0ml white opaque round HDPE 18mm screwed neckMedisize bottle 3 5095 Relevant, As per packing policy り ， l Smm screw-on white pump and actuator with white cap Export Item No.2 Azelastine Hcl Ophthalmic Solution 0.05% W/V 6ml bottle S. No. Imports Proposed Qty. Recommended. l Azelastine Hcl 3.l5mg/bottle 2. lOmlNatural HDPE Rispharm Sterile Dropper Relevant, As per packing policy ● フ 13mm White Opaque HDPE Pilfer-proof Rispharm Sterile Cap for Dropper (Barnali Khastgir) Phone:23071162

F. No.350 11 1757 1201 s-Pl (Norms) Government of lndia Dated: 2, May 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case

of M/s Sriam Labs Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011186/AM-16/DES- 311299 dated the 16112115 vide which application from M/s Sriam Labs Pvt. Ltd. was sentto this Department for fixation of norms under para: 4.7 for the export of Diethyl (3,5-dimethoxy benzyl) phosphonate (ADDP-2). 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 ltem Norms Recommended for 1kg Export 1 3,5-dihydroxy benzoic acid 0.667k9 2 Potassium carbonate 1.194k9 3 Sodium borohydride 0.423k9 4 Triethyl phosphite 0.932k9 2. (Rajkumar) PH.- 23071162 孝

la-, F. No.35011t7811201s-Pl (Norms) 4,4/ Government of lndia \u Dated: 26 April, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case

of M/s Sun Pharmaceutical lndustries Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011295/AM-16/DES- 311237 dated the 15/1 2115 vide which application from M/s Sun Pharmaceutical lndustries Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Clarithromycin Carbomer Granules 43.75%144%. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14:- DGFT is advised to call following details from the firm viz:-

  1. Copy of valid DML for above export product.
  2. Copy of Master-Batch formula duly certified by Q.C. incharge.

(Rajkumar) PH- 23071162

′撼 “ qレアタ 593/ Meet No/Date:39/82- Status:Case ALC4/20H 27.12.2011 Lic.No/Date:0310657928 104.10.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Chemicals & Petrochemicals vide their U.O No. 14010t8312010/Ch.ll daled26.12'2011 in consultation with technical authority present ln meeting, decided to ratify norms under para 4 7 HBP as per details below or as applied by firm whichever is lower:- concerned may take further necessary action as per above decision of NC Approved 99 1/82/050/00948/AM12/

Government of lndia 'lb' Dated: 26 April,2016 Office lvlemorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol l) 2009-14 Case

of M/s Sun Pharmaceutical lndustries Ltd. The undersigned is directed to refer to DGFT U.O No. 01/82/50/1291/AM- 16/DES- 3/1232 dated the 15/.12l15 vide which application from M/s sun Pharmaceutical lndustries Ltd. was sent to this Department for fixation of norms under pa.a: 4.7 for the export of Clarithromycin Carbomer Granules 43.75o/o144%.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 frrm viz:-

  1. Copy of valid DML for above export product
  2. Copy of MasterBatch formula duly certified by Q.C. incharge'

(Ralkumar) Under Secretary to the Government oflndia PH: 23071162 D recto「ate Ceneral of Foreign Trade, (Shtt M V Singh,FTDO). Udyog Bhawan,New Delhi ハ

?., F. No.35011r8'l/201s-Pl (Norms) 1/
Government of lndia lu Department of Pharmaceulicals Dated: 26 April,2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case

of M/s Sun Pharmaceutical lndustries Ltd. The undersigned is directed to refer to DGFT U.O.No. 01i82/50/1438/AM-16/DES- 3h407 daled the 11/'ll16 vide which application from M/s Sun Pharmaceutical lndustries Ltd. was sent to this Department for fixation of norms under pa?. 4.7 for the export of Clarithromycin Carbomer Granules 27.5/28%. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- DGFT is advised to call following details from the firm viz:-

  1. Copy of valid DML for above expo( product.
  2. Copy of Master-Batch formula duly certified by Q.C. incharge.

(Rajkumar) PHi 23071162 (Shri M.V. Sinsh, FTDO),

け 一 昨 Export product Exp Qtv Sl.No. lmport items Qty. allowed Calcium Citrate 1 Cltlc Acid 0 816 kg Calcium Carbonate 0 708 kg Magnesium Citrate 1 Cirlc Acid 1 001 kg Magnesium Carbonate 0.730 kg Potassium Citrate Citric Acid 0 859 kg Zinc Citrate Citnc Acid 0.880 kg m.y t.k. .pp-priate action as per the decision of Norms Committee: : |をlζき N8::i:ウ/6/82‐ IP:ly｀五品Ъ :こLbЁAL IMCCtNo/Date:8/82- Status: : | ILC42014 1綜踏ッ PⅢVATE I錯尉鰍Υ 'pproVed ‐ | 1鵠星憶 ::1:::;1↓lζ 聯ち jlij:lili" |しこ赫 51bttittbbi46:感 : 、M14/ :10 04 2014 Date:121120141 1 :Decision:ln the light of wntten cOmments received from Department of Chemicals andi l PetrOchemicals vide their U.O No 14010/56/2011-Ch.‖ dated 09 10.2014,■ was decided tol 1182 rhemicals vide their U.O No' r4olol5bl/.vLl'-Ln. ll oareo uv'ru'zur4, rL wd5 norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, ever is less:

lG7 F. No.350 11 17981201 s-Pl (Norms) Government of lndia Deparlment of Pharmaceuticals Dated: June,2016 Office Memorandum Case of M/s Belco Pharma' The undersigned is directed to refer to DGFT U.O.No. 01182150114371AM- 16/DES-3/1426 dated the 1111t16 vide which application from M/s Belco Pharma. was sent to this Department for fixation of norms under para: 4.7 'for the export of Hydrocortisone Gream BP 1o/o wlw, Sgm and 1Sgm tube and hydrocortisone ointment Bp 1%w/w, Sgm and 1Sgm tube. This department has examined the matter and the following normJ are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- (Rajkumar) PH.23071162 ネ 2. (Shri M.V. Singh, FTDO)' UOyog Bhawan, New Delhi

  1. For Export of Hvdrocortisone cream/ ointment 1%, sqm
  2. For Export of Hvdrocortisone Cream/Ointment 1%' 1Sqm Tube

′子 ′び7 :Approved IHQ File lRLA File li01/82/050/00543/AM15/ 1:07/24/040/00474/AM14/ :Lic.No/Date:0710104601: ●0,20И : 26 8 :Decision:ln the light of wtttten comments received from Department of Chemicals and iPetrOChemicals vide their U.O No.14010/56/2011-Ch.‖ dated 28.05.2012′ it was decided to l『 llli』j[周:|::ler Para 4,7 of HBP Vl as per deta‖ S giVen be10W Or aS applied by the firnl′ | SI. No. Export product Exp. Qty_ lmport items Qty AIlowed 1 MAGNESIUM LACTATE GLUCONATE l kg GLUCONATE DELTA LACTONE 0.755 KG COBALT GLUCONATE l kg 1.036 KG ZINC GLUCONATE l kg 0.945 KG MAGNESIUM GLUCONATE l kg 0.945 KG POTASSIUM GLUCONATE l kg 0.930 KG FERROUS GLUCONATE l kg 0.887 KG MANGANESE GLUCONATE l kg 0.945 KG CALCIUM MANGNESIUM LACTATE CLUCONATE l kg 0.831 KG RA may take appropriate action as perthe decision of Norms Committee. : / Namc:GLOBAL PRIVATE

や ン （ 　 　 ▲ 一 ） Govemment of lndia Ministry of Chemicals and Fertilizers Department of Chemicals and Petrochemicals Sublect: Advance AuthOnzaoon app‖ calon from M′s Benzo Chem industnes Pvt Ltd fOrthe 圏野 lg晰]:」TaettST震‖雪瀧器欧漁8,卵ぷ総躍辮 C‖°Ю 翻器酬燎雲肝遭淵窯 =態 留′ :」:品→ ‰詰雅::『m」叩臓7.c柵電き i引思躙朧智誦:な警踏:‖亀用 :°¶謬 (N,N DIMETHYLAMINO)-2‐ PHENYL‐ 1‐BUTANOL■は The app‖cation has been examined and the Department recommends the fo‖ o哺ng norms forthe present Advance AuthOnzation application This issues with the approval of comp€tent autho ty. ぃに儡 ヽr Addl lndustdal Adviser Tel No 011-23381430 Deptt oF C&PCUO No 031079,1375 dated 25 11 2014 ltem of ExPort Qty. item of!mport Qty 3‐ ChiOroBenzy! Chio「ideノ Meta Chloro Benzyi ChiOnde l kg 1 . Meta Chloro Toluene 0 982 kg 2 A20 BiS:Sobutyro Nitnle 0 01l kg rnce Authorization No. 03'1071 1619 dnl ed / ltem of Export Qty. Item of lmpo( Qty 2‐(N,N DIMETHYLAMiNO)‐ 2‐ PHENYL‐ 1‐BUTANOL l kg l PROP10PHENONE 2.10 kg 2 METHANOL 2 88 kg 3 SODIUM CYANIDE 0 768 KG 4 CAuSTIC soDA FLAKES 1 00 KG 5 DIMETHYL SULPHATE 1 019 KG 6 FORMALDEHYDE 0 660 KG 7 SYNHYDRIDE/VITR:Dl 2 412 KG 14010ノ29ノ2011‐ CH‐l:dated

F. No.3501 1 /86 61201 s-Pl (Norms) Government of lndia Dated: 1B MaY,2016 Office Memorandum

subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (vol.l) 2009-14

Case of M/s Kopran Research Labs Ltd. TheundersignedisdirectedtorefertoDGFTU.o.No.ollS2l5oll59TlAM- 16/DES-3/1743 dated the 2t3l16vide which application from M/s Kopran Research Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Doripenem sterile. This department has examined the matter and the foliowing norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14:- . DGFT is advised to call following details from the firm viz:-

  1. Complete technical detail as per appendix-33 showing chemical reactions, % yield on molar basis etc.
  2. Copy of technical literature in support of yields envisaged'
  3. pasi production vis-d-vis actual consumption of imported inputs duly certified by Central Excise Authorities.

This issues with the approval of competent authority' (Ralkumar) Under Secretary to the Government oflndia PH:-23071162 Depanment Of COmmerce, (Sh"M∨Singh,FTDO), Udy09 Bhawan,New Delhi

堵 諄炒財赫~1糖 8 lmν
円 Decision:ln the nght Of w百tten comments received from Petrochemical D市ision of Department of Chemicals and Petrochemicals vide their U.O No.46011/20/2013-PC‐ ll dated ll.10.2013′ k was declded to raJfy n9rms under Para 4.7 of HBP vl as per detalls g市 en below or as app!ied by the nrm′ whichever is :ess: Export product Exp. Qty・ Sl.No. Import items Qty. allowed INTRAUTERINE CONTRACEPTIVE DEVICE COPPER T380Ag l kg 1 COPPER WIRE(PURITY OF COPPER+SILVER 99 99%) 0.00038 kg RA may take appropriate action as per the decision of Norms Committee. 」

F. No.3501 ,442r2011-pr (Norms) 6-' Government of India Udyog Bhawan, New Delhi,the22nd February, 2012. Office Memorandum Sub: Fixation of norms under para4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case of M/s CIPLA LTD. The undersigned is directed to refer to DGFT u.o.No. 011821501692lAM121DES-3/1200 dated the 22l9ll1 vide which an application from M/s CIPLA LTD was sent to this Department for fixation of norms under paru: 4.7 for the export of 19 EXPORT ITEM AS BELOW. This department has examined the matter and the following comments are furnished under pata 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- (1)Exportltem No。1. I valve and 19ml alu Aerodini 100 mcQ inhaler(200md)With 58 mcl aeroso nllnlurn can Imnorts Proposel For expo■ofl No.Inhder 1 Salbutamol 0.02gms 2. 58 mcl Aerosol Valves As per packing policy 3. 19 ml Aluminium Can 4. 0.48 mm OD Actuators with Dust CoversiCaps 5. 1,1,1,2 -tetrafl uoroethane (HFA 1 3 4A Propellant) l8.20gms Export Item No.2. Salbutamol 100mcg can. inhaler (200md) with 50 mcl aerosol valve and 19ml aluminium Export Item No.3. Beclometasona diproPionate 19ml aluminium can. 50mcg inhaler (200md) with 63 mcl aerosol valve and Imports Proposel For cxport of l No.Inhalcr 1 Beclometasona diproPionate 0.0lgms (2) (3) Imports Proposel For cxport ofl No.Inhalcr 1 Salbutamol 0.020gms 2. 50 mcl Aerosol Valves As per pack ng policy 3. 19 ml Aluminium Can 4. 0.48 mm OD Actuators with Dust Covers/Caps 5. l,l,l,2 -tetrafl uoroethane (HFA 1 3 4 A Prope I lant) 14.40gms

ヽ （ (4) 2. 63 mcl Aerosol Valves 3. 19 ml Alurniniurn Can 4. 5. 1,1,1,2-tctrafluoroethane(HFA134A Propellant) 17.74gms 6. Ethanol 0.456gms Export Item No.4. Beclometasona dipropionate 100mcg inhaler (200md) with 63 mcl aerosol valve and 19ml aluminium can. Imports Proposel For cxport ofl No.Inhaler 1 Beclometasona dipropionate 0.02gms 2. 3. 19 ml Alullninium Can 4. 5. l,l,l,2 -tetrafl uoro ethane (HFA 1 3 4 A Propel I ant) 17.288gms 6. Ethanol 0.912gms (5) Export Item No.5. geclometasora dip.opionate 200mcg inhaler (200md) with 63 mcl aerosol valve and 19ml aluminium can. Imports Proposel For cxpo■ofl No.Inhder 1 0.04gms 2. 3. 19 ml Aluminium Can 4. 5. !,1,1,2 -tetrafl uoro ethane (HFA 1 3 4,A. Propellant) 16.37gms 6. Ethanol 1.824gms (6) Export Item No.6. Beclometaronu dip.opionate 250mcg inhaler (200md) with 63 mcl aerosol valve and lgml aluminium can. Imports Proposel For exoort of I No. lnhaler 1 0.05gms 2. ０ つ 19 ml Aluminium Can 4. 5。 1,1,1,2-tetrafluorocthane(HFA134A Propellant) 15.90gms 6. Ethanol 2.28gms

(8) (7) Export Item No.7. Budespray 200mcg HFA inhaler (200md) with 58 mcl aerosol valve and 19ml aluminium can. Imports Proposel For export of I No. Inhaler 1 Budesonide 0.04gms 2. 3. 19 ml Alulniniulln Can 4. 5. 1,I,1,2 -tetrafl uoro ethane (HFA 1 3 4 A Prope I I ant) 18.2gms Export Item No.8. Budespray 100mcg HFA inhaler (200md) with 58 mcl aerosol valve and 19ml aluminium can. Imports Proposel I Budesonide 0.02gms 2. 3. 19 ml Alurniniulln Can As per packing pol Cy 4. As per packing pol Cy 5. 7,1,1,2 -tetrafl uoroethane (HFA 1 3 4,A. Propellant) 18.2gms (9)Exportltem No.9. mcl aerosol valve and 14ml aluminium can. Salmeterol inhaler 25mcq. (120md) with 63 mcl aerosol valve and I4ml alumtnrum Imports Proposel For export of 1 No. Inhaler I Salmeterol 0.003gms 2. 3. 14 ml Aluminium Can 4. 5. 1,7,1,2-tetrafl uoroethane (HFA 1 3 44. Propellant) 12.50gms 6. Ethanol 0.256gms (10) Export Item No.10. Fluticort plus -25mcg HFA inhaler (120md) with 63 mcl aerosol valve and 14ml aluminium can. Imports Proposel 1 Salmeterol 0.003gms 2. Fluticasone Propionate 0.015gms 3.

14 ml Aluminium Can 5. 6. l,l,l,2 -tetrafl uoroethane (HFA 1 3 4,A Propellant) 12.5gms 7. Ethanol 0.256gms (11) Export Item No.ll. Fluticort plus-25Omcg HFA inhaler (120md) with 63 mcl aerosol valve and 14ml aluminium can. Imports Proposel 1 Salmeterol 0.003gms 2. Fluticasone Propionate 0.03gms 3. 4. 14 ml Alulrninium Can 5. 6. 1,1,1,2 -tetrafl uoro ethane (HFA 1 3 4 A Prope I lant) 12.5gms 7. Ethanol 0.256gms (12) Export Item No.12. Fluticort plus-50mcg HFA inhaler (120md) with 63 mcl aerosol valve and l4ml aluminium can. Imports Proposel Salmeterol 0.003gms 2. Fluticasone Propionate 0.006gms 3. 4. 14 ml Aluminium Can 5. 6. 1,7,1,2 -tetrafl uoro ethane (HFA 1 3 4.A. Propell ant) 12.5gms 7. Ethanol 0.256gms (13) Exnort Item No.13. Berlomethasone dipropionate 50mcg and salbutamol 100mcg hnhaler (200md) with 50 mcl aerosol valve and 19ml aluminium can. Imports Proposel For export ofl No.Inhaler 1 0.01gms つ ４ Salbutamol 0.02gms Ｏ Ｊ 50 mcl Aerosol Valves 4. 19 ml Aluminium Can 5. 6. 1,1,1,2 -tetrafl uoroethane (HFA 1 3 44. Propel I ant) 14.04gms 7. Ethanol 0.36gms

‐ （ (14) Export Item No.14. Fluticasone propionate 50mcg inhaler (120md) with 63 mcl aerosol valve and 14ml aluminium can. Imports Proposel 1 Fluticasone propionate 0.006gms 2. 3. 14 ml Aluminiurn Can 4. 5. 1,1,1,2 -tetrafl uoroethane (HFA 1 3 4A. Propellant) l2.5gms 6. Ethanol 0.256gms (15) Export Item No.15. Fluticasone propionate 125mcg inhaler (120md) with 63 mcl aerosol valve and 14ml aluminium can. Imports Proposel For expo■ofl No.Inhder 1 Fluticasone propionate 0.015gms 2. 3. 14 ml Aluminium Can 4. 5. 1,1,1,2 -tetrafl uoroethane (HFA 1 3 4 A Propel I ant) 12.5gms 6. Ethanol 0.256gms (16) Export Item No.16. Fluticasone propionate 250mcg inhaler (l20md) with 63 mcl aerosol valve and l4ml aluminium can. Imports Proposel For expo■ofl No.Inhaler 1 Fluticasone propionate 0.03gms 2.

。 （ 3. 14 ml Aluminium Can 4. 5. l,l,l,2 -tetrafl uoro ethane (HFA 1 3 4,A. Propel I ant) 12.5gms 6. Ethanol 0.256gms (17) Export Item No.17. Formoterol fumarate inhaler lZmcg (l20md) with 40 mcl aerosol valve and 10ml aluminium can. Imports Proposel 1 Formoterol fumarate 0.0014gms 2. 40 mcl Aerosol Valves Ｏ Ｊ 10 ml Aluminium Can 4. 5. l,l,l,2 -tetrafl uoro ethane (HFA I 3 4,A' Prope I lant) 7.84gms 6. Ethanol 0.16gms (18) Export ltem No.18. Formoterol fumarate and budesonide inhaler 100/6mcg (120md) with 58 mcl aerosol valve and 19ml aluminium can. Imports Proposel 1 Formoterol fumarate 0.0007gms う ん Budesonide 0.012 3. 4. 19 ml Aluminium Can As per packing pol Cy 5. As per packing po Cy 6. l,l,l,2-tetrafl uoro ethane (HFA 1 3 4 A Prope llant) 12.2gms (19) Export ltem No.19. Formoterol fumarate and budesonide inhaler 200l6mcg (120md) with 58 mcl aerosol valve and 19ml aluminium can. Imports Proposel For cxpo■ofl No.Inhder 1 Formoterol fumarate 0.0007 2. Budesonide 0.024gms 3. 4. 19 ml Aluminium Can 5. 6. l,l,l,2 -tetrafl uoro ethane (HFA 1 3 4 A Propellant) 72.Zgms 7. Ethanol NIL 3. Above recommendations are subject to the condition that:-

⌒ (a) Import of GFA 134A Propellant and its quantity is subject to NOC from MOEF. (b) Requirement of HFA 134A Proopellant is inclusive of allowances for permissible loss in weight on storge and priming losses. (c) The firm will maintain separate record on HFA 134,4' Propellant import & consumption. This issues with the approval of Deputy Director General. NoN.Ah可a) Section Offlcer PI‐NORMS 4. (Lalita Maini (Mrs), FTDO), Udyog Bhawan, New Delhi.

物 F. No.350 1 1 18721201 5-Pl (Norms) Government of lndia Dated: 24May,2016 Office Memorandum Case of M/s Malladi Drugs & Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501148714M- 16/DES-3/'1694 dated the 1912116 vide which application from M/s Malladi Drugs & Pharma Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of 4-methyl-5-phenyl-2-oxazolidinone(Racemic Oxazolidinone). 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:- (Rajkumar) PH:- 23071162 2. S.No. lmport item Norms Recommended for 1kg of export Propiophenone 2.44kg 2 Diethvl carbonate 1.00k9 3 Toluene 7.89ks 4 lsopropvl alcohol 1.91ks 5 Heptane 2.71kg 6 Acetone 0.47kg 7 Caustic soda flakes 0.48kg

Case No.:75/39/82‐

IALC4/2010 194 1/ ,Party Name:ARKEMA ;PEROXIDES INDIA PRI L|MITED ,/ leet No/Date:39/82‐ ALC4/2010 AMl1/ 04.10.20 FttVmmα αttA日剛ID I盤 蔑尻胤停 試 “ り鍵‐ 器 器 e l
レ&122010 1 Illメ::)。50/01156/AMl1/ 1:甘」 )∫li040/00580/ 一

「 ―― Decision present applied I ,RA concerned may take further necessary action as per above decision of NC.

Case No.:81/39/82‐

ALC4/2010 iStatus:Case lApproved larcq/zoro I 28.12.2010 LiMITED IRLA F‖ e Lic.No/Date:0210148843‐ HQ File HLI l'llg KLA rlle LrL!r!v, I :oLlS2lOsOlOLL62IAMLLI,:o2l24lo4o10012uAM11l oa.ro'zoro Decision : Committee considered case as per agenda and in light of written comments of Dept. of ‐ IC&PC COnveved vide U.0。 No。 14010/98/2010/Ch.‖ dated 03.01.201l and in conSultation with 95 techniCal authottty present in meeting′ decided to ratify norms under Para 4.7 of Handbook of′ IProcedures as per deta‖ s below or as app‖ ed for by firm whiCheverislower:‐ Export product Export Qty. SoNo. Name of ltem of imPort Quantity allowed Sodium Butyrate l Kg. n-Butyric Acid 0.842 RA concerned may take necessary action as per above NC. HQ File RLA File :01/82/050/01156/AMl1/ 1:03/94/040/00580/AMl1/ 覇批iW革薦皿骨 lT淵/ /'::J性Fl:]:2:03105950i31 1∫T‖∬ ir誕|'m鴨諾7喫 Export product Exp. Qtv。/ メ(No. lmport items Qt"Wed Lumartem Tablets/Co- Falcinum/Artmether and Lumefantrine Tablgt ./ [Artemether = /,/2O mg/tabletl ,/ Artemether fequired per tatir4/-zo.4 mc) after 2%fiaslaee ″;)ノ jゝ:て5・ Artemissin tt.s kel ke of Artemether 2. 認鶏耐e/ 0.188 kg/kg Of Artemether 3. [umefantrf^r{e 122.4 mg 4. ／ し 脚雌 Pentapharm ACLAR PA 200ノ2 254/51 PVCノACLAR As per packing policY |

Case No.:82/39/82‐

ALC4/2010 蔦 Decision : Committee decided to case for 25.01.201l fol Status:Case 'Deferred IDate:25.01.2011 Pharmaceuticals. Partv Name:DSM ANTl‐ nents of Department of 7781わさfer ~~~ Party Name:WEST BENGAL CHEMiCAL:NDUSTRIES No.:32/39/82‐ NoノDate:39/82‐

「 易 ALC4/2012 24.04.2012 concerned may take further necessary action as per above decisio,n of NC' Party Name:IhlDO AMINES LIMITED as applied by the firm, whichever is less:

⌒ l1 25q F. No.350 1 I 18412014-PI (Norms) Government of India Udyog Bhawan, New Delhi, the October, 2014 Office Memorandum

Subject: - Fixation of norms under para4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of

M/s Elppe Chemicals Pvt Ltd. The undersigned is directed to refer to DGFT U.O.No. 0ll82l50l979lAM-L4|DES-3/1094 dated the 0ll01ll4 vide which application from M/s. Elppe Chemicals P\4 Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Phenyl Thio Proline. This department has examined the matter and the following norns are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S. No. Import Item 1 Irans-4-hydroxy-L-prol ine 1.574 2. Isobutyl acetate 4.56 3. Methane sulfonyl chloride 1.68 4. Ihio phenol 0.839 This issues with the approval of Director (Cost). (Barnali Khastgir)

250 一 ‐ ‐ ， ‥ iCase No.:145/10/82- :ALC4/2013 Patty Nallle:METROPOLITAN EXIMCHEM LTD Mcet No/Datei1 0/82- ALC4/2013 22082013 :HQ File ::O1/82/050/00328/AM14/ :RLA File lLic.No/Date:0310733925 :Defer Date: ::03/95/040/00076/AM14/ 10.05.2013 1 つ 一 Decision : In the light of rvritten comrnents received fi'om Depaftrnent of Clremicals and Petrochemicals videtheirU.ONo. l4OlOl6Ol2O12-Ch. IIdated2l .3.2O13,itwasdecidedtoratifynornrsunderPara4.Tof HBPvlasperdetailsgivenbeloworasappliedbytlrefirnr,rvhiclreverisless: Item of Export Quantity S,No Itenr of Import QLrantity allowed DADAS (4,4-Diamino Diphenylamine Sulfate l kg 1 4.4-Diamino Diphenylanrine 2 Sulfonic Acid 1 260 kg つ ´ Activated Carbon 0 150 kg RA nray take appropriate action as per the decision of Nornts Contnriftee.

『釧… 82‐ALC鉤 Party NameiBENZO CHEM INDUSTR!ES PRI∨ATE ILIM!丁ED, Meet No/Date:4/82‐ Status:Case lALC4/201l Approved 126042011 鵬星λ 5餅∞∞ 6ハⅢν l胤鵬餅∞ "5ハⅢγ 繭可 20 ― 　 　 　 　 ・ cn : Committee considered case as per agenda and in light of written comments forwarded by lment of C&PC vide their 14010110612004/Ch.ll dated 28.07.2008 and in consultation with or as applied by firm whichever is lower:- Export product Exoort Qtv. SI No lmport item Qty. allowed Para Chloro Meta Cresol l Kg 1 Meta Cresol 1.232 kg 2. Sulphuryl Chloride 1 660 kg

ル ブ

:66/21/82‐ ALC4ノ2012
|
Party Name:SHIVA
PHARMACHEM LTD,
IMeet No/Date:25/82‐
‐ALC4/2012
129.11.2012
Status:Case
Approved
IDefer Date:
|
|
:01/82/050/00696lANll3l \:34/241040100139/AMl3/ 27.oB.Zotz 
i
Decision : In the light of written comments received from Department of Chemicals and
Petrochemicals vide their U.O No. 1401011641201l-Ch. II dated l7.11.2012, it was decided
to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the
firm" whichever is less:
Export Product
Export Qty.
SI No
lmport items
Qtv.
allowed
lso
Butyryl
Chloride/Butyryl Chloride
Appearance: Clear
colourless liquid
l kg
1
lso Butyric Acid
Appearance:- Clear colourless
liquid
0 870 kg
may tat<e ippropriate action as per the decision of Norms Committee.

我
⌒
:01/82/050/00790/AM 13/
239
## Case No.:87/22/82‐ ALC4/2012
Party Name:AVA CHE MiCALS
:03/94/040/00308/AM13/
|        :      |
)n : ln the light of written comments received from Department of Chemicals and
ηemica:s vide their U.O No.14010/157/2011-Ch.‖
dated 17.11.2012′ ヒwas decided to ratify
under Para 4.7 of HBP vl as per deta‖
s given below or as app‖ ed by the firm′ whichever is
Export product
Exp.Qtv,
SI.No.
lmport items
Qty. allowed
EDttA    Ferric
Ammonlum‐
Liquid
l kg
1.
Ethylene Diamine Tetra Acetic Acid
(EDttA)
0.412 kg
may take appropriate action as per the decision of Norms Committee.
No/Date:26/82-

t7
F. No.350 1 | I 609 l20l 4-Pl (Norms)
Govemment of India
7bs
Udyog Bhawan,
New Delhi, the 
April, 2015
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l)
2009-14 Case of M/s Posy Pharmachem Pvt Ltd.
The undersigned is directed to refer to DGFT U.O.No. 0ll92l50l853lAi|.l-
15/DES-3/839 dated the 26111114 vide which application from M/s. posy
Pharmachem Pvt Ltd was sent to this Department for fixation of norms under para:
4.7 for the export of Citric Acid Anhydrous USP/KOSHER. This department has
examined the matter and it is requested that DGFT may call following technical
details from the firm viz:-
(a) COA ofExport product.
(b)COA of Import item from Foreign Supplier.
2. 
This issues with the approval of Director (PI).
(Bamali Khastgir)
Phone:23071162
Depar"tment of Commerce,

旱
ラ
F. No.3 50 1 ll 417 1201 4-Pl (Norms)
Govemment of India
Shastri Bhawan,
New Delhi, the 22"d January 201 5
Office Memorandum
Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-
14 Case of IWS Alembic Pharmaceuticals Ltd.
The undersigned is directed to refer to DGFT u.o.No.
011821501351lAM15/DES-31442 dated the 3017114 vide which an application from
M/s Alembic Pharmaceuticals Ltd was forwarded to this Department for fixation of
input- output norms under para: 4.7 against export of Tablet formulation
containing Irbesartan and Hydrochlorothiazide in various strengths. This department
has examined the matter and following information may be called for from the
applicant to enable this Department process the request:-
(a) Copy of Master-Batch Formula for each strengths of export product duly
certified by their Q.C. In charge, showing net content of APIs and each of the
excipients.
2. 
This issues with the approval of Director (Pharma Industry)
(Raj Kumar)
Phone:-2307'l 162

## Case No.:6ノ24/82‐ALC4/2009
多
RLA F‖ e
:05/24/040/00242/AM10/
LicoNo/Date:0510248395
26.08.2009
IALC4/2010
20.04.2010
Party Name:KLJ PLASTiCiZERS
LTD′
:01/82/050/00503/AM10ノ
cision : Comnlittee considered case as per agenda and in!ight of wr:tt
partment of C&PC{PoC.Division)vide their ooM.No。
46011/97/1009‐ P(
nsuLauon wtth technical authoHty presentin meeung′
dedded to ratifv
per deta‖ s below oras app‖ ed by firm whicheverislower:‐
en comments forwarded by
:.il dated 20.04.2010 and in
norms under para 4.7 of HBP
Export product
Export Qtv.
S:。No.
!mport items
Qtv. allowed
Kanato1 8080
l Kg.
Tere Phtha‖ c Acid
0。447 kg
2.
z-Ethvl Hexanol
0。752 kg
3.
HM‐HDPE Granu!es
No/Date:3/82‐
|
|

⌒
F. No.3 50 l 1 1 665 120l,2-PI (Norms)
Government of India
Office Memorandum
ヽW田L耐鵬脚
## subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (vol.l) 2oog-14 case of M/s. Dhanuka
Labs Ltd.
The undersigned is directed to refer to DGFT U.o.No. otlB2/50/6s5lAMl3/DES-3/g4l dated the 0g/10/12
vide which an application from M/s. Dhanuka Labs Ltd was sent to this Department for fixation of norms under
para:4.7 for the export of Cefditoren Pivoxil. This department has examined the matter and the following comments
are fumished under para 4.7 of Hand Book of procedures (vor.r) 2oog-14:-
S No
Import Item
Qty. Recommended kg/tg.
l
3CLE
friphenyl Phosphine
1626
■
一
４
一
■
3odium lodidc
1612
MTHA
1 722
Propan -I -ol(n-Propanol)
６
　
一
■
3hiorofOrlll
Methanol
８
　
一
９
Potassium Metabisulphite
Phenol
1984
lrifluoro Acetic Acid
075
Acetone
2250
ⅥAEM
1 166
Ｂ
　
一
Ｌ
lriethylamine
Sodium-2-Ethyl Hexanoate
240
\-N-Dimethyl Formamide
に
　
一
‐
７
letrabutyl Ammonium Bromide
0064
)ichloro Methane
253
3hloromethyl Pivalate
0548
{ctivated Carbon
0200
2. 
This issues with the approval of Director (Cost).
(Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi.
(N.N.Ahtta)
Section Offlccr
PI―Norlns

ケ
一
甥
１
　
２
⌒
ICase No.:87/24/82-ALC4/2012,Paltt Nanle:METROPOLITAN IMeet No/Date:8/82‐    istatus:casel
l                  EXIMCHEM LTD.       ALC4/2013         :Approved l
l―――‐―、一一―― ――― ― ― _ ___ i     ‐―                  .11.07.2013            :          :
' Decision : In the light of written comments receivecl f.oliDepa,t;i;;ii-;f Ch;i;ii;;i;;A
Petrochemicals vide their U.O no. 14010/6012010-Ch. il clateci 10.7.2013, it was decicled:
75 tO ratif3/nOrms undcr Para 4.7 of HBP vl as pcr details g市
en be10w Or as apphed by the
:RLA File               Lic No/Date:0310710207 :Dcfer Date: :
|:03/95/040/00466/AM13/   124.092012        1      1
:HQ File              lRLA File             'Lic No/Date:0310710207 :Dcfer Date:
|:01/82/050/00891/AM13/   103/95/040/00466/AM13/   124.092012      1
whichever is less:
Item of Exporl
Export Qty
S.No
Item of Import
Oty A1lowed
4(2-Cliloroethyl
Sulfonyl)-
Butyrychloride
lkg
1
Gamrna
Butyrolactone
0.684kg
2
2 Mercapto
Ethanol
0.755kg
RA rnay take appropriate action as per tt . a..irim orNrl* cCI,.lritt.e.

ハ
―
―
)η
_
えSヽ 、
2_´_
IHQ Filc                  RLA Filc                 ,Lic_No/Datc:0310721594  :Dcfer Datc:
:01/82/050/01303/AIN11 3/       :03/95/040/00698/ノヘヽ113/       21 01_2013              1
Decision : In the light of earlier decision taken irr nreetinq no.23182
as per details given
dated 6.89.?011. it was
belorv or as applied by
Rハ、lllay take appropriate action as per thc dccision ofNol・
lllS COllllllittCC.
Export product
Exp
Qty.
Si No
Import items
Qty. allowed
5-Amino 6 methyl
Benzimidazolone
l kg
1
3,4-Diamino Toluene (Melene)
1 200 kg
2
Hydrazine Hydrate (as 80%
basis)
1 022 kg

F No 35011/437/2015-Pl(Norms)
Government oflndia
Ministry of Chemical&Fertilizers
Department of Pharmaceuucals
Dated: August,2016
Office Memorandum
Case of M/s Alchem lnternational (P) Ltd.
The undersigned is directed to refer to DGFT U.O.No. 0118215015391AM-16/DES-
3/610 dated the 1517115 vide which application from M/s Alchem lnternational (P) Ltd.
was sent to this Department for fixation of norms under para'. 4.7 for the export of
Digoxin. 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
Digitalis Lanata Leaves
266 64kg/kg Digoxin
export
2. 
(Rakumar)
Under Secretary to the Government oflndia
PH:-23071162
Depanment Of Commerce,
(Sh面M V Singh,FTDO),
Udyog Bhawan,New Delhi
場

F. No.3501 1113812016-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 Optimus Drugs (P) Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01lBZtSOt266tAM-17/DES-
3t228 dated the 6/7/16 vide which application rrom turs optimus Drugs (p) Ltd. was sent
to this Department for fixation of norms under para: 4.7 for lhe export of sofosbuvir.
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 1kg Export
2-deoxy -2-lluoro-2-methyl uridine
0.90ks
2
N-t(S)-(2,3,4, 5,6-pentafluoro phenoxy) phenoxy
phosphinyll-L-Alanine 1-methylethyl ester
1.92ks
2. 
(Rajkumar)
PH:- 23071162
Udyog Bhawan, New Delhi.
ム
尤

場
89
Party Name:KLJ
PLASTICIZERS LTD,
necessary
per
## Case No:29/16/82-
ALC4/2011
鵬
肌
5餅∞お7ハⅢν 
日乳厨駐餅00428ハⅢν 
卜ξ慨
17晰
舵%刊lT~~~:
ion : Committee considered case as per agenda and in light of written comments forwarded by
rtment of C&PC vide their U.O. No.140101212010-Ch.ll dated 04.06.2010 and in consultation with
ical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details
/ or as applied by firm whichever is lower:-
Export product
Exp. Qtv.
SI No
lmport items
Qty. allowed
Kanato1 400(Di― iso/N― Butyl
Phthalate)
l kg
1
Phtha!ic Anhydride
0 560 kq
2
lso/Normal Butanol
0 560 kg
No/Date:20/82‐
/2011

F. No.350 1 1 I 1451201 6-Pl (Norms)
Government of lndia
考
Dated: July,2016
Office Memorandum
Case of M/s Orbit Life Sciences (P) Ltd.
The undersigned is directed to refer to DGFT U.O.No. 011821501308/AM-17/DES-
31218 dated the 6ft116 vide which application from M/s Orbit Life Sciences (P) Ltd. was
sent to this Department for fixation of norms under para: 4.7 for the export of lmipenem
(Sterile / Technical / N-Formimidoyl / Thienamycin 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:-
DGFT is advised to call following details/clarification from the firm viz:-
1) Whether the export item is sterile or technical grade.
2) lf sterile, please give details of conversion from tech. grade to sterile alongwith
yield etc.
3) The DML furnished by the firm is only for exporUmanufacture imipenem (Non-
Sterile). How the firm will be manufacturing/exporting Sterile product.
4) The import items at appendix-11A do not tally with ANF-4A.The correct and
revised list of import items may be furnished as many inputs have been shown
indigenous in appendix-1 1A
2. 
(Raikumar)
Under Secretary to the Government oflndia
PH:-23071162
Udyog Bhawan, New Delhi.
レ

F. No.350l tt62t2ot5-Pl (Norms ) 
>
Government of India 
-.qri
'/
Department of Pharmaceutical s
Udyog Bhawan,New Delhi,
Dated 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 Sun
Pharma Industries Ltd.
The undersigned is directed to refer to DGFT U.O.No. 0l18215011167lAM-151DES-3/1108 dated
the l9l01/15 vide which application from M/s. Sun Pharma Industries Ltd was sent to this Department for
fixation of norms under para: 4.7 for the export of Azelastine Hydrochloride Nasal Solution (Nasal
Spray). This department has examined the matter and the following norrns are furnished under para 4.7 of
Hand Book of Procedures (Vol.l) 2009-14:-
Export Item No.l
Azelastine Hcl Nasal solution (Nasal Spray) 0.1% (137mcg per spray) 200 MD-----------1No.
S. No.
Imports Proposed
Qty. Recommended.
1
Azelastine Hcl
28.77mg/vial
2.
l0ml white opaque round HDPE 18mm screwed
neckMedisize bottle 35095
Relevant, As per packing policy
●
Ｊ
l8mm screw-on white pump and actuator with white cap
Exnort Item No.2
Azelastine Hcl Ophthalmic Solution 0.05% WA/ 6mlbottle
(Barnali Khastgir)
Phone:23071162
S. No.
Imports Proposed
Qty. Recommended.
l
Azelastine Hcl
3.1 5mg/bottle
2.
l0ml Natural HDPE Rispharm Sterile Dropper
Relevant, As per packing policy
3.
l3mm White Opaque HDPE Pilfer-proof Rispharm
Sterile Cap for Dropper

γ
携
鴨Cジ
F. No.3501 1 178312015-Pl (Norms)
Government of lndia
Shasttt Bhawan,New Delhi,
Dated the August 22,2016
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:
Application from M/s Encube Ethicals Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O. No. 011821050/01378/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.
Ｎ
Ｓ
　
Ｏ
Name of
Export
Product
Ｎ
Ｓ
）
０
lnputs recommended
100 tubes
of14 gm
100 tubes of
42 gm
100 tubes
of28 gm
1
Miconazol
e2%
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 om
3.
Mineral O‖
42 qm
126 gm
84 om
4.
Oleoyl PolyoxylglVcerides
42 gm
126 gm
84 gm
5.
Butylated hvdroxva nisole
0.0728 gm
0.2184 gm
0.1456 gm
6.
Miconazole
28.56 gm
85.68 grTT
57.12 gm
7.
Empty Laminated Printed
tubes of correspondlng
sizes
As per Packing Policy
S. N
O
Name of
Export
Product
Ｎ
Ｓ
　
ｏ
lnputs recommended
100 tubes of 45
gm with 1
applicator
100 tubes of 45
gm with 7
applicators
2
Miconazole
2o/o Creams
Benzoic Acid
0。900 om
0.900 gm
2
Pegoxyl 7-stearate
900 gm
900 om
3.
Mineral()il
135 gm
135 gm
4.
Oleovl Polvoxvlqlvcerides
135 gm
135 gm
5.
Butylated hydroxyanisole
0.234 gm
0.234 gm
6.
Miconazole
91.80 om
91.80 om
7.
tubes of corresponding sizes
8.
1 or 7 applicators as per
product specification
100 packs of
one applicator
each
100 packs of
Seven applicator
each
＼

-2‐
S.No
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 gm
280 om
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 gm
8.
Sodium 
Phosphate
Monobasic
2.24 gm
4.4gm
9.
tubes of corresponding sizes
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(ls
or 7s packs)
(100 pack
of1
applicator
each)
(100 pack of 7
applicators
each)
2
Cetostearyl Alcohol
450 gm
450 gm
3.
9ctyllqdecanol
607.50 gm
607.50 gm
4.
Cetyl Esters
135.000m
135.00 gm
5.
Sorbitan Monostearate
90.00 gm
90.00 gm
6.
Polysorbate 60
67.50 gm
67.50_qm
7.
Clotrimazole
45.00 gm
45.00 gm
8.
Benzyl Aにoha
45.00 gm
45.00 gm
9.
Sodium Phosphate MonobasiC
7.200m
7.20 gm
10.
tubes of corresponding sizes
S.No
Name of
Export
Product
S.No
lnputs recommended
100 tubes of
14 gm
100 tubes
of28 gm
5
Triple
An面biouc
Ointrnent
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 corresponding sizes
As per Packing Poticy

-3-
S.No
Name
Of
Export Product
S.No
lnputs recommended
100 tubes of 14 gm
6
Triple 
MS
Antibiotic
Ointment
White Petrolatum
Quantity not indicated
in the Batch formula
2.
Polymyxin B Sulfate (non-
sterile)
28.56 MU
3.
Bacitracin Zinc
18.05 gm
4.
Neomycin Sulfate (micronized)
9.996 gm
5.
tubes of corresponding sizes
S.No
Name 
of
Export Product
S,No
lnputs recommended
100 tubes
of28 gm
100 tubes
of14 gm
7.
Triple Antibiotic
Ointment
WlPRAM
White Petrolatum
277.6032
gm
138.8016
gm
2.
Pramoxine HCL
28.56 gm
14.28 gm
3.
Bacitracin Zinc
18,05 gm
9,025 om
4.
Polymyxin B Sulfate (non―
sterile)
14.28 MU
7.14 MU
5.
Neomycin S ulfate (micronized)
571.2gm
285.6om
6.
lqbes of corresponding sizes
S.No
Name of
Export
Product
S.No
!nputs
recommended
100 tubes
of56 gm
100 tubes
of14 gm
100 Tubes
of28 gm
|
8
Triple
Anubiouc
Ointment EF
Cocoa Butter Ultra
Natural
2.5 gm
63 gm
126 gm
2.
White Petrolbtum
Quantity not indicated in the Batch
formula
3.
Super 
Refined
Cottonseed
238 gm
59.5gm
119 gm
4.
Super Refined Olive-
LQ
14 gm
3.5 gm
7gm
5.
Vitamin E Acetate
126 gm
31.5gm
63 gm
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 gm
7.22
14.44 gm
9.
Empty Laminated
Printed tubes ' of
corresponding sizes

-4-
S.No
Name 
of
Export Product
S.No
lnputs recommended
100 tubes
of14 gm
100 Tubes
of28 gm
19,
Double
Anlbiotic
W/PRAM
Cream
Emulsifying wax
168 gm
336 gm
2.
Mineral()il
112 gm
224 gm
3.
White Petrolatum
56 gm
112 gm
4.
Poloxamer 188
0.0182 gm
0.0364 gm
5.
Propylene Glycol
280m
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
S.No
Name of Export
Product
S.No
lnputs recommended
100 Tubes of
28 gm
10
Allergy WlZinc
Cream
Cetyl Alcohol
448
2
Pglysorbate 60
84
3.
Sorbitan Monostearate
196
4.
PrOpylene_clycol
140
5
IMethyl Paraben
7
6.
Diphenhydramine Hydrochloride
57.12
7.
Zinc Acetate
2.856
8
Empty Laminated
gs:zes
As per Packing
Policy
０
Ｎ
　
¨
Ｓ
Name of Export
Product
S.No
lnputs recommended
100 Tubes
of14 gm
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.
tubes of corresponding sizes

-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.
!!es of corresponding sizes
Name of
Export
Product
lnputs recommended
100 Tubes
of28 gm
100 Tubes
of56 gm
Hydrocortisone
l%    
○丁C
Cream
The requirement oi
various inputs not
tally with 
Batch
Formula and DML
available in 
the
application.
Sorbitan Monostearate
Anhydrous Citric Acid
Empty Laminated printed
lLrLes of corresponding sizes
Name of
Export
Product
lnputs recommended
100 Tubes of 28 gm
Hydrocortisone
l%   oTc
Ointment
White Petrolatum
Mineral oil
Empty Laminated printed
!g!qs of corresponding sizes
As per Packing
S,No
S,No
13
Glyceryl Stearate
2
White wax
3.
コ
I Alcohol
4.
lsopropyl Myristate
5.
Celyl Alcohol
6.
7.
Polysorbate 60
8.
Propyl Paraben
9
10.
Sodium citrate
Methyl Paraben
12.
SOrbic Acid
13.
PolyOxy1 40 Stearate
14.
9d
15.
HydrOcOrtisone _
16.

-6-
S.No
Name of Export
Product
S.No
lnputs recommended
100 Tubes
of28 gm
100 Tubes
of56 gm
HydrocorUsone/
Aloe 1o/o Cream
Anhydrous Citric Acid
0.98 gm
1.96 gm
2
Sodium citrate
1.68 gh
3.36 gm
3.
Methyl Paraben
5.60m
11.2gm
4.
Sorbic Acid
1.4 s,
2.8gm
5
Polyoxyl 40 Stearate
14 gm
28 gm
6.
Propylene Glycol
98 gm
196 gm
7.
Glyceryl Stearate
56 gm
112 gm
8.
White wax
84 gm
168 gm
9.
StearylAlcohol
28 gm
56 gm
10.
lsopropyl Myristate
224 gm
448 gm
petyI Alcohol
84 gm
168 gm
12.
Sorbitan Monostearate
84 gm
168 gm
13.
PolysOrbate 60
84 gm
168 gm
14
Propyl Paraben
2.8gm
5.6gm
15.
Hydrocortisone
0.02856 gm
0.05712 om
Aloe Concentrate
2.8gm
5.6gm
17.
tubes of corresponding
sizes
S.No
Name
Of
Export Product
5,No
lnputs recommended
100 Tubes of28 gm
16
Hydrocortisone
Plus 12 Cream
mus citHc Acid
0.980
2.
Sodium citrate
1.680
3.
M21hyl Paraben
5.600
4.
SOrbic Acid
1.400
5.
…
14.000
6.
Propylene Glycol
~98.000
7.
Glycettn
7.000
8.
Slyqeryl Stearate
56.000
9.
VVhite vvax
84.000
10.
QlqarylAlcohol
28.000
lsopropyl Myristate
224.000
12.
Sorbitan Monostearate
84.000
13.
Polysorbate 60
84.000
14.
Propyl Paraben
2.800
15.
A/1ineral()il
7.000
16.
White Petrolatum
7.000
17.
Cetosteryl Alcohol
7.000
18
lsopropyl Palmitate
2.800
19.
Vitamin A&D3
7.000
20.
Aloe Concentrate
2.800
21.
Hydrocortisone
28.560
22.
_Cety!Alcohol
841000
23.
Empty Laminated printed tubE
of corre ponding sizes
As per Packing policy
15
16

-7‐
●
０
Ｓ
Ｎ
Name of Export Product
S.No
Inputs recommended
100 Tubes of
56 gm
17
Hydrocortisone 0.5% Cream
Mgthyl Paraben
0.112 gm
2.
Sorbic Acid
0.056 gm
3.
Polyoxy1 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 Myristate
4.48 gm
8
Qetyl Alcohol
1.68 gm
9.
Sorbitan Monostearate
1.68 gm
10.
Polysorbate 60
1.68 gm
en
0.056 gm
12.
Propylene Glycol
1.12 gm
13.
壁drOCOrtisone
0.28 gm
14.
Ulgs of corresponding sizes
As per Packing
Policy
3
This issues with the approval of Director (pharma lndustry).
Phone: -23071162
Email: - uspi3-pharma@nic.in

IT
4t)
FF. No.3 50 1 1 I 426 12015-PI (Norms)
Government of India
f'l
Udyog Bhawan,
New Delhi, the October, 2015
Office Memorandum
## Subject: - Fixation 9f lorms under para 4.7 of H*a gook of Procedures (Vol.l) Z00g-14 Case of IWs
Dhanuka Labs Ltd.
- 
The undersigned is directed to refer to DGFT u.o.No. 0tll2l50l220+45olAM-I6/DES-3/155
dated the 08107115 vide which application from M/s. Dhanuka Labs Ltd was sent to this Department for
fixation of norms under para:4.7 for the export of cefixime USP/Bp/Ip/Bp/Jp. This department has
examined the matter and the following norns are furnished under para 4.7 of Hand Book of procedures
(Vol.l) 2009-14-
S. No.
Import Item
1
7-Phenylacetamideo-3 -Chloromethrl-
Cephalosporanic Acid Para Methoxy Benzyl Ester
(GCLE)
1.50
つ
４
Iriphenyl Phosphine
0.82
3.
へCCtOne
0.81
4.
N,N Dimethyl Formamide
2.74
5.
Dichloromethane (Methylene Chloride)
3.40
6.
rnemylamme
0.2717
7.
Phenol
0.3808
8.
Methanol
4.21
9.
ACtlVated Carbon
0.050
10.
MICA Estcr
0.82
Tetra Hydrofuran
1.64
(Barnali Khastgir)
Phone:23071162

F. No.3501 1 /52 1 1201 5-Pl (Norms)
Government of lndia
Department of *Pharmaceuticals
Shastri Bhawan, New Delhi,
Dated the January 18,2016
Office Memorandum
## subject: - Fixation of norms under para 4.7 of Hand Book of procedures about request
of M/s lndoco Remedies Limited.
The undersigned is directed to refer to DGFT U.o.No. 01/82lo5o/00768/AM-
16lDEs-31717 dated the 0410811s vide which application from M/s. lndoco Remedies
Limited was sent to this Department for fixation of norms under paru: 4.7 for the export of
ciprofloxacin tablets in 250 mg, s00 mg & 750 mg strengths. 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:-
Description of lmport
Item
Quantity Recommended (per tablet)
Per250 mg
rabrer
Per 500′ηg
rabrer
Per 750 mg
ねbrer
Ciprofloxacin
Hydrochloride
277 5 mg
555 mg
832.5 mg
2
M´ ′
This issues with the a
反
        (212)14/'′
of competent authority.
p,,bl' aa)'a""' td Y orv'
面
々
ｐ
﹈
ハ
(Ral Kumar)
Under Secretary to the Government Oflndia
Phone:-23071162
Directorate Cenera1 0f Foreign Trade,
Depattment of Commerce,
(Shn M V Singh,FTDO),
Udyog Bhawan,New Delhi

|フ
暫
F. No.350l lll38l20ll-PI (Norms)
Government of India
Udyog Bhawan,
New Delhi,the 4th January9 2012
0fflce Memorandum
Sub: Fixation ofnollllS under para 4.7 ofHand B00k OfProcedures(Vol.1)2009-  14 Case ofⅣ1/sENCUBE
ETHICALS LTD.
The undersigned is directed to refer tO IDGFT u.o.No.01/82/50/126/ANI112/DES-3/146 dated the
06/05/1l vidc which an applicatiOn from NI1/s ENCUBE ETHICALS LTD was sentto this Department
for flxation Of norlns under para:4.7 for the export of RELAXIT IⅦICROENEMA 5 1ⅦL.This
departrnent has examincd thc mattcr and the fo110wing cOmments arc fumished undcr para 4.7 of Hand
Book of Proccdures(VOl.1)2009-14:¨
S.No.
lmport ltem
Qty. Recommended.
1. 丁RI―SODIUM CITRATE DIHYDRATE
450 mg per 5 ml pack
2 50DIUM LAURYL SULPHAttE
75 mg per 5 ml pack
3 MICROENEMA ttUBES EMPIY
AS PER PACKING POL!CY
2. 
This issues with the approval of Deputy Director General.
o.N.Ahtta)
Scction Offlcer
PI―NttRMS
(Lalita Maini (Mrs), FTDO), Udyog Bhawan, New Delhi.

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r'7
4-970
F. No.3 50 ll 16481201 3-PI (Norms)
Government of India
Udyog Bhawan,
November,20t4
New Delhi, the
Office Memorandum
Case of IWs Ciron Drugs & Pharma Pvt Ltd.
The undersigned is directed to refer to DGFT U.O.No. 0ll82l50l447lAM-l4IDES-
3157g dated the gOlOg/13 vide which application from M/s. Ciron Drugs & Pharma Pvt
Ltd was sent to this Department for fixation of norms under parai 4.7 for the export of
Can-C Eye Drops. ThiJ department has examined the matter and the following norms are
furnishedunder para 4.7 of Hand Book of Procedures (Vol .l) 2009-14-
S.No.
Import Item
Qty. Recommended.
1 N-Acetyl-Carnosine
0.051gm/5ml vial
Thir irr*s with the approval of Director (Cost)'
(Barnali Khastgir)

l?
F. No.350 tU33gt2O14-pI (Norms) 9q t
Govemment of India
Udyog Bhawan,
New Delhi, the November,2014
Office Memorandum
Case of IWs Venus Remedies Ltd.
The undersigned is directed to refer to DGFT U.O.No. 011821501183/AM-15/DES-
31251dated the 13/05 l14 vide which application from M/s. Venus Remedies Ltd was sent
to this Department for fixation of norms under para: 4.7 for the export of Aztreonam for
Injection. This department has examined the matter and the following norrns are
furnished under para 4.7 of Hand Book of Procedures (Vol .l) 2009-14-
S.No.
Import Item
Qty. Recommended.
Aztreonam for Injection USP (containing 780
mg of L-Argenine per gm of Aztreonam)
1.869 gml20 ml vial
This issues with the approval of Director (Cost).
(Barnali Khastgir)

⌒

D-
3q'-
F. No.3501 1/47 12016-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 Amol Pharmaceuticals (P) Ltd.
The undersigned is directed to refer to DGFT U.O. Nos. 011821050101741/AM-16/DES-
3/1903 dated the 30.03.2016 vide which application from M/s Amol Pharmaceuticals (P) Ltd.
was sent to this Department for fixation of norms under para. 4.7 for the export oI AZO
Urinary Tract Defense. This department has examined the matter and the following norms
are furnished under para 4.7 ol Hand Book of Procedures (Vol.l) 2009-14: -
2
This issues with the approval of competent authority
(Ral Kumar)
Under Secretary to the Government oflndia
Phone:-23071162
Ema‖ :uspi3‐pharma@nにin
Directorate Cenera1 0f Foreign Trade,
(Sh"M V Singh,FTDO),
Udyog Bhawan,New Deihi
S
No.
Export ltem
Quanlty
lmport ltem
Quanuty a:iowed
for 1000 tablets
AZO Urinary Tract Defense
(each tablet containing 162 mg
Methenamine)
1 000 tablets
Methenamine
163.6gm

|
八
髪
## Case No.B20
M/s.Global Calcium
Norms Committee Meeting No.2/AMl3
F.No 01/82/50/00630/AM 12/DES HI
Meeting Date: I 0.04.2012
RA File No.07/24/40/00140/AM 12
Adv.Lic.No.0710080871 dated 25.07.2011
Decision: lt was decided to revise norms earlier fixed on the basis of production and
consumption data, duly certified by Central Excise Authority, under Para4.7 of HBP vl as per
details given below or as applied by the firm, whichever is less:
per the decision of Norms Committee'
Export Product
Export
Quantity
Import items
Quantity allowed
Calcium Levulinate
lkg
Levulinic Acid
1.156 kg

境   ヽ
F No 35011/706ノ2015-PI(Norms)
Government oflndia
Ministry of Chemical&Fertilizers
Department of Pharmaceutlcals
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 Alivira Animal Health Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01182150197814M-16/DES-3/1 119
dated the 26111115 vide which application from M/s Alivira Animal Health Ltd. was sent to this
Department for fixation of norms under para: 4.7 for the export of Clozasole 3400 and
Clozasole 900 (Tetramisole Hcl & Oxyclozanide Bolus). 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
Tetramisole Hcl
2000mg/Clozasole 3400 Bolus
And
450mg/clozasole 900 Bolus
夕
、ァニ
わ
た
ぃ、劇
t e HS "9r q {+tlq.iv F-G-d,{k-G
υ労よ胤
蹴筆荘,l .. (!c<"n .t 4o. 'nrl "ttn ,
2
(Ralkumar)
Under Secretary to the Government oflndia
PH:-23071162
Depanment Of Commerce,
(Shn M V Singh,FTDO),
Udyog Bhawan,New Delhi

r-?-
Lzol
F. No.3501 1 /76 41201 s-Pl (Norms)
Government of lndia
Dated: 5, May 2016
Office Memorandum
## subject: - Fixation of norms under para 4.7 of Hand Book of procedures (Vol.l) 2009-14 case
of M/s Fresenious Kabi Oncology Ltd.
The undersigned is directed to refer to DGFT U.o.No. o1tB2lsot1272tAM-16/DES-
3/1318 dated the '16112115 vide which application from M/s Fresenious Kabi Oncology Ltd. was
sent to this Department for fixation of norms under para: 4.7 for the export of bocetaxel
lnjection concentrate 160m9/8m1, 120mg/6m1, 80mg/4ml and 20mg/1m1. This department
has examined the matter and the following norms are furnished under para 4.7 of Hand Book
of Procedures (Vol.l) 2009-14:-
DGFT is advised to call following details from the firm viz:-
1. Copy of the relevant DML for each export item.
2. copy of MasterBatch formula for each export product duly certified by e.c. incharge.
3. Consumption coefficient of raw material for 1kg Apl.
4. Wastage claimed on API for each formulated product to be exported.
2. 
(Rajkumar)
PH.23071162

♯
F. No.350 I 1 i42 1201 6-Pt (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 Satyadeva pharmaceuticals (p) Ltd.
. _- The undersigned is directed to refer to DGFT U.o.No. o1tB2tsor1764tAM-16/DES_
3/1881 dated the2213116 vide which application from M/s Satyaoeva pharmaceulicats 1p) Ltd.
was sent to this Department for fixation of norms under para: 4.7 Ior the export ot i+n_cis;_t,l _
dimethylethyl-5-(2-aminoethyr)-2,2-dimethyr-1,3-dioxane-,4-acetate. ri.rii uefartment nas
examined the matter and the following normi are furnished under para l.i iifi^na Book of
Procedures (Vol. l) 2009-1 4:-
S.No.
lmport item
Norms Recommended for
1kg Export
1
(4R-Cis)-1, 1 -dimetnytetnyt-O+yanonretny-2_
dimethyl-1, 3-d ioxane-4-acetate
1.01k9
2
Under secretary to the o"r"r.r$ijji,Ti,?
PH- 23071162
Udyog Bhawan, New Delhi.

rI
F. No.350 11t176t2016-Pl (Norms) a{
Government of lndia
Dated: August, 2016
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2OOg-14 Case
of M/s lnd. Swift Labs Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01tBZtSOt1g4 & 269/AM-17/DES-
31240 &252 dated the 8t7t16 vide which application trorn tr4ls lnd. Swift Labs Ltd. was sent to
this Department for fixation of norms under para: 4.7 for the export of Clarithromycin Granules
27 -5o/o (Suspension Grade). This department has examined the matter and the following
norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2OOg-14:-
S.No.
lmport item
Norms Recommended For 1kg
Export
/1
Eryth romycin thiocya nate
0.706kgA/kg
2
Triethylamine
0.236kg
3
Methanol
2.266kg
4
Methylene chloride
1.166kg
5
2-methoxy propene
0.1 98kg
6
Dimethyl sulfoxide
1.32kg
7
Hydroxylamine Hcl
0.382kg
8
lsopropyl alcohol
3.401kg
／
０
ノ
Carbopol
0.20kg
ヽ」
'/
HPMC Phthalate
0.54kg
2.
ο岬濁写uい℃ぶ靭:
(Shri M.V. Singh, FTDO), Udyog Bhawan, New Delhi.
4ハ沸証
f″
|卜05 ツ

No i41/26/82-
1
Name:TATVA
No/Date:26/82-
PHARMA CHEM
1
Approved
10｀FIも~~~… ……~~~―‐―RLA Fib~~~~~~~ ――
Lじ:ヽ6′ bЪtei0416031416. ‐   |
101/82/050/00724/AM12/     134/24/040/00o86/AM12/     lo5 09 2011
Ded●on i cOmmttee∞ngdeた
t電:、.馬1:潟::118rll:螢∬:∫嶋
lぷTtti『71Ж冒薔
|:I
Department of c&Pc vide their t
ヽ
A′ i'hl●ハhniハら:^:``卜^´ :`:^^__^_^_■:_    |
tech雨酬
釧騎雨∝
「
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酬h冊
:::llis悧「:b dψ  mmSm“
rpara 47 σ HBPぉ阿
‖s below or as app‖ ed by firm wl
IRA concerned may take further necessary actiOn as per above decisiOn Of NC

|}
勉
F. No.350 I I 12621201 5-PI (l'lorms)
Government of India
Ministry of Clremical & Fertilizers
New Delhi,the
I..Jdyog Bhawan.
October" 2015
J町∝
“
げ∝Ⅳ
“
りη"J4眈
e
鋤…屏搬ι鶴l胤:出∫節
a47J}
dttd ttlサ蹴FT::S髯冊琳蹴:FWttPttI:選T脇鷲M16齢SFFi
欄彙拙習H鷺‖押ξ」こ鳥」
Ⅷ嚇瑞驚
I』螂L路
(Barnali Khastgir)
Phone:23071 162
Qty. Recommended kgikg.
Import ltem
t ncelactum (+)ZAzab icyclo [2'2' I ] hept-5 -en-3 -
)(On 100%basiS)
-(24m tno.4,6-Dichloropyrim idine-5-yl)
(-)-Tartaric Acid
ium Borohydride
riethyl Ortho Formate
lopropyl Amine

ヘ
' 
\ -l-- t6'
-W
'#_ 5tt 
?
F. No.3501 1 t2912016-Pl -Norms
Government of lndia
DePartment of Pharmaceuticals
Shastri Bhawan, New Delhi
New Delhi, the December 19,2016
Office Memorandum
## subject: - Fixation of norms under para 4.7 of Hand Book of procedures (Vol.l) 2009-14 case
of M/s tndoco Remedies Ltd'
The undersigned is directed to refer to DGFT U.O. No' 01lB2tO5OtO1841lAM-16/DES-
3/16 dated fie o+.dq.2016 vide which apprication from- M/s rndoco Remedies Ltd. was sent to
this Department for fixation of norms ,*j", para: 4.7 for the export of Bimatoprnst 0'3 mg i
ml Eye Drops, solution 3 mt Bottle. This department has examined the matter and the
folowing norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14: -
Export ltem
QuantitY
・
　
０
Ｓ
Ｎ
lmport ltem
Quantity allowed
for 100 bottles
Bimatoprost 0.3 mg I
ml Eye Drops, Solution
3 ml Bottle (each ml
contains: BimatoProst
0.3 mg)
1 00 bottles
Bimatoprost
94.5 mg
2.
Eye Drop Bottle
As per packing
Policy
3.
Eye Drop CaPs
4.
Eye Drop lnsert
2) This issues with the approval of competent authority'
fgYJ,'r-A-fu
(Barnali Khastgir)
Phone: 23323292
Email: barn.khast@nic.in
(Shri Nirmal KumAr, DY DGFT),
Email: nirmal.kumar65@nic. in

け
一
％
F. No.3501 1/1 8212016-Pl (Norms)
Government of lndia
Dated: August,2016
Office Memorandum
Case of M/s IPCA Labs Ltd.
The undersigned is directed to refer to DGFT U.O.No. 0118215013291AM-17/DES-
3/261 dated lhe8l7116 vide which application from M/s IPCA Labs Ltd. was sentto this
Department for fixation of norms under para: 4.7 for lhe export of Allopurinol. 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
// /          lmpon tem
_4、
Norms Recommended
For 1kg Export
噸
3-aminb pyrazole carboxamide hemisulphate
1 538kg
2
Formam ide
1 50kg
2. 
(Ralkumar)
Under Secretary to the Government oflndia
PH■23071162
Directorate General of Foreign ttrade,
Depa■ment of Commerce,
(shn M v singh,FTDO),
Udyog Bhawan,New Delhi

51多
F. No.350I I176112013-PI (Norms)
Government of India
Department of Pharmaceutical s
Udyog Bhawan,
New Delhi, the 04th March, 2014
Office Memorandum
## Subject: - Fixation of norms under para4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of
M/s Suven Life Sciences Ltd.
The undersigned is directed to refer to DGFT U.O.No. 0ll82l50l890lAM-|41DES-311074
dated the 3lll2ll3 vide which application from M/s. Suven Life Sciences Ltd was sent to this
Department for fixation of norms under para: 4.7 for the export of Benzhydryl Thioacetamide.
This department has examined the matter and the following norns are furnished under para 4.7
of Hand Book of Procedures (Vol.l) 2009-14:-
S.No.
Import Item
1
Hydro Bromic Acid
1.20
2.
Thio Urea
0.45
3.
Benzhydrol
0。99
4.
2-Chloro Acetamide
0.50
This issues with the approval of Director (Cost).
(Rtt Kumar)
Undcr Secrctary to the Govemment oflndia
PI―Nolllls
(Shd R.C. Meena, Dy. DGFT),
Udyog Bhawan, New Delhi.

Ｈ
一
彎
F. No.350l ll53l20l4-Pl (Norms)
Govemment of India
Udyog Bhawan,
New Delhi, the October, 2014
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (vol.l) 2oog-14 case of M/s Gland pharma
Ltd.
The undersigned is directed to refer to DGFT U.o.No. ot/B2l5o/gt2lAM-14/DES-3ltot2 dated the
09/12/13 vide which application from M/s. Gland Pharma Ltd was sent to this Department for fixation of norms
under para: 4.7 for the export of Adenosine Injection USP Prefilled Syringe 3mg/ml, 4ml in a pFS.
- 
The present application is for Export of Amiodarone Pre-filled Syringes in USFDA plant and the export is
to USA' In the past in NC meeting No.40/l I dto4loll2oll in the light 6f re=port of sub-committee dt 3ll0g/2010
the norms-committee allowed 28%o wastage on Barrel Syringes (dlass), Needle Shield (Rubber) and plunger
stoppers (Rubber) and 8Yo wastage on Plunger Rods(Plasticj Consumables were allowed on Net to Net basis. In the
present case, lthe f,rrm has applied the same wastage on components. The case was considered in norms-committee
in the past, and the firm was advised to furnish Froduction -consumption Data duly certified by central Excise
Authorities alongwith Batch Log sheet.
The firm has given the details and the comparision of norms may be seen as under:-
SI.No.
Import Item
(l)
Norlns
Applied
(2)
As per Central
Excise Certificate
(3)
Batch
Logsheet
(4)
Lowest of(2)
to(4)
l
Adenosine
0.0132
gm/vial
N.A.
NIL
00132
gm/vial
2
ia..ql Syringes (Glass)
1.28 Nos.
1.1095
NIL
1.1095 Nos.
1.2942 Nos.
1.03 Nos
NIL
1.03 Nos.
4
Plunttr stOppers(Rubber)
1 28 Nos.
1.1481
NIL
1.1481 Nos.
_Plμnger Rods(Plastic)
1 08 Nos
1.03 Nos.
NIL
1.03 Nos.
6
Filters (Plastic)
Consumable, on Net to Net Uasis
7
…
LS・C)
Reference Standards
present case may be considered specific to
Under Secremvゎme G虚:器:I瞥:需は
In accordance with the earrier dicisions of Norms-committee,
USFDA project and Export to USA only.
This issues with the approval of Director (Cost).
DirectOrate Genera1 0f Foreign Trade,
Department OfcOmmerce,
(Shri M.V.Singh,FTDO),
Udyog Bhawan,New Delhi

x7
5z-=
F. No.350 l 1 1 53212012-PI (Norms)
Government of India
Udyog Bhawan,
New Delhi, the 26th December, 2012.
Office Memorandum
Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case of M/s
Mylan Labs Ltd.
The undersigned is directed to refer to DGFT U.O.No. 011821501230/AMl3/DES-3/331 dated the
28105112 vide which an application from lzl/s Mylan Labs Ltd was sent to this Department for fixation of
norms under para: 4.7 for the export of Montelukast Sodium. This department has examined the matter
and the following comments are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 -
S. No.
Import Item
1
2-(2-(3 -(S)-(3 -(2-(7-Chloro-2-quinol inyl)-
ethenyl)phenyl)-3 -hydroxypropyl)phenyl )-2-propanol
1.424
2.
1 -(Mercaptomethyl)cyclopropane acetic acid
0.60
L(+) Tartaric acid
0.643
4 N,N-Di isopropyl ethylamine
0.30
5 Ioluene
4.97
6 Acetonitrile
7.09
7
sopropyl ether
1.00
8 Methylene chloride
9.s6
9 Acetone
2.13
10 Methanol
3.90
N-methyl 2-pyrrolidone
Not shown in reaction scheme.
2. 
This issues with the approval of Director (Cost).
(N.N.Ahuja)
Section Officer
PI-Norms
(Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi.

け
⌒
隼武¬
No/Datei1 0/82-
2
No/Datei031 067373
122011
Decision : Decision : Committee considered case as per agenda and in light of written comments
Jed by Deptt of C&PC vide their U O No 14010/29/2011-Ch‖
dated 25 05 2012 decided to ratify
under para 4 7 of HBP as per detalis below or as app!:ed by firm whicheveris iower:‐
RA concerned may take further necessary action@
２
８
６
“
９
３
１
．
¨
１
０
＾
０
Ｎ
厖
NameiBENZO CHEM
DUSTRIES PR!VA丁巨
:01/82/050/01255/AM12/
:03/94/040/00856/AM12/
IHQ File
RLA File
144
Export product
恥
Ｑ
ｔ
ｙ
SI No
lmport items
Qty. allowed
2,5-Dimethyl PhenyI Acetyl
Chio面de
l kg
Para Xylene
1 485 kg
2
Paraformaldehyde
1 032 kg
3
Sodium Cyanide
0 570 kg
4
Caustic Soda Flakes
0 500 kg
5
Thionyl Chloride
0 980 kg

l7
5L1
F. No.350 l 1 1379 12012-PI Qrlorms)
Government of India
Udyog Bhawan,
New Delhi, the 
th October, 2012.
Office Memorandum
Sub: Fixation of norms under para4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case
of M/s Mylan Labs Ltd.
The undersigned is directed to refer to DGFT U.O.No. 0ll82l50l1478lAM|2|DES-3/49
dated the 09104112 vide which an application from M/s Mylan Labs Ltd was sent to this
Department for fixation of norms under para: 4.7 for the export of Atovaquone. This department
has examined the matter and the following comments are furnished under para4.7 of Hand Book
of Procedures (Vol.l) 2009-14-
S. No.
Import Item
1 4-(4-Chlorophenyl) Cylohexyl Carboxylic Acid
2.00
2. 2-Chloro- 1,4-Naphthoquinone
1.62
3 Sulpholane
1.00
4. Toluene
2.40
5. Acetonitrile
6.8s
6. Dichloromethane
l.60
7. Methanol
1.68
2. 
This issues with the approval of Director (Cost).
(N.N.Ahuja)
Section Officer
PI-Norms
(Mrs. Lalita Maini, FTDO),
Udyog Bhawan, New Delhi.

r+-
:01/82/050/00559/ANl13/
Decision : In the light of written comments received l'rorn Department of Chemicals and
petrochemicals vide their U.O No. l401Ol2gl2}l l-Ch. II dated 25.5.2012, it was decided to
ratify norms under Para 4.7 of HBP vl as per details given below or as applied by the firm'
r^rhichever is less:
Export product
Exp.
Qtv
SI No
lmport items
Qty. allowed
Para Chloro PhenYl
Acetic Acid
l kg
Para Chloro BenzYl
Cyanide
1.021 kg
2
Toluene
0.230 kg
3.
Caustic Soda Flakes
0.360 kg
the decision of Norms Committee'
t7
-/<>Y
|
:
182

_マ
ヘ
g/´ぜ
`.『f
Government cFlndia
Min:sI「/cf Cher,cals and Fe晨
:||三ers
Depa嵐menioF Chemicals and Pet「ochemicals
Subject Ad*.'ance Authorizaiicn aoplicaiion ri'om l.rts l#c 
Labs Ltd., for lh= inrport
maierial a-o"inst the export of 9-oxo-EH-Thioxanih rn{z- carboxylic acid eihyl esier
Ref: u.o. No. 01tlasat1rcty*do4-u r/1e iated 11.6.2015
l;l/s Vivimed Labs Ltd.,have sr-rbmitted present aoplicaiidis for the irnport of rar"r' material
against the e:<port of 9-oxo-gH-Thioxanthene-2- carbo;<ylic acid ethyl ester
The application have been examined and the Departrnent reccmmends the iollovring
norrns for the present Advance Authorizaiion applicaiions.
リア
of ra'*v
ltem Of exoort
Qty.
Itenr of impcrt
1町
町
に驚露榔甜ξ
『
l kg.
1. Thioselicylic Acid
2. 4-bromo Uenioic aciO
1.723 kg
3. 丁hionyi ch10ride
4.700 kg
4. l-olu:na
1.970 kg
tD.じarbOn
0_060 kg
This issues r,,rith the approrralof compeient authority.
九
d‡  
ゞ
Tel.No,oll‐ 23381430
Vikra
|
Deptt- of C&PC u.o.
14∝γ138/2011-      i
/
Delhi一

F. No.3501 I I 487 12012-PI (Norms)
Government of India
ん
π′ノタ
Udyog Bhawan,
l4th November,2012.
New Delhi,the
Office Memorandum
Sub: Fixation of norms under para4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case
of M/s Morepen Labs Ltd.
The undersigned is directed to refer to DGFT U.O.No. Oll82l50ll70lAM13/DES-3/208
dated the 26104112 vide which an application from Mis Morepen Labs Ltd was sent to this
Department for fixation of norms under para: 4.7 for the export of Atorvastatin calcium' This
department has examined the matter and the following comments are furnished under para4'7 of
Hand Book of Procedures (Vol.l) 2009-14:-
2. 
This issues with the approval of Director (Cost)'
N.N.Ahuia)
Section Offlcer
PI―Nolllls
iMrs. t alita Maini, FTDO), Udyog Bhawan, New Delhi'
Fluoro-(Alpha)-(2 -Methyl-2 - Oxopropyl)-
ma-oxo-N-(Beta)-Diphenyl Benzene
4R―Cis)‐ 1,1-Dimethylethyl-6-Cyanomethyl-2,2-
imethyl- 1,3 -Dioxane-4-Acetate
iisopropyl ether
Import Item

^
112
:Decision : In the light Of、vritten colnnlents received fl・oln Departinent of Cheinicals and
PctrOchenlicals vidc their U.O No. 14010/102/2012-Ch.II datcd 20.5.2013,it was dccidcd
to ratify norms under Para 4.7 of HBP vl as per dctails g市
en below Or as applied by the
flrnl,、vhichever is less:
Export product
Exp.
Qty.
SI.No.
Import items
Qty. allowed
DTBHBA or3,5-
DTBHBA
l kg
1
2,6 Di Tcl・t ButyI Phenol
3.280 kg
2.
P-Fornialdehyde
0.716 kg
う
Ｄ
Hexane
1.841 kR
RA uray take aporooriate action as lrer the decisiorr of itlorrrrs Corrrnri
appropnate
he decision of irtronns Committee.
Party7 Nanle:VIVIMED LABS
LIMITED
125.072013
IHQ File      ‐
101/82/050/01124/AM12/
RLA F‖ e
:09/24/040/00276/AM12/      10809.2011              1
iCase No.:89/42/82-ALC4/2011

^
∫g0
.Meet No/Datei21/82-
:ALC4/2011
123082011
:Lic No/Date:0310642729
118072011
iStatusiCase
:Approved
I 
| _. 
I er 
rsvvu(y 
rsr rE
::, 
RA concerned may take further necessary action as per above decision of NC.
Export pr9duct
Exp. Qtv.
SI No
lmport items
Qty allowed
Uctylated Diphenylamine
(OCD Flakes/Powder)
l Kg.
DiphenylAmine
0.405 kg
2
Di―lsobutylene
0 680 kq
:  J
一
―
―
…
…
―
―
―
一
一
一
凛
:
:

ζ 々
:Party Nallle:SuNSHiFLD   IMect No/Date:8/82-   lStatus:     :
iCHEMiCALS LTD       :ALC4ノ2014        :Appl‐ 0、.ed   i
25092014            
‐             |
ICase No.:104/6/82-
‐ALC4/2014
‐HQ Filc              RLA Filc             lLic No/Datc:031()781246 Dcた
r Datc:   :
|:01/82/050/00506/AM15/   :03ノ95/040/00!15/AM 15ノ   109052014
1  1Decision:in the light Of wntten cOmments rece市
ed from Department of ChemicaL andi
l  Petrochemicals vide their u.o No.14010/107/2010-Ch 
‖dated lo 10.2014′
■was decided tol
:  iratify norms under Para 4.7 of HBP vl as per detalL given below or as applied by the irm′
|
233:WhiCheveris!ess:
Export product
Exp
Qtv
SI No
lmport items
Qty. allowed
Suncon 100 (Octylated
Butylated Diphenylamine)
l kg
Di-lso butl,lene
0 503 kg
Diphenl,lnnllps
0 553 kg
:RA may take appropnate acuOn as perthe decision of Norms Commtttee.           :

身
F. No.350l l/50912012-PI (Norms)
Government of India
Minishy of Chemical& Fertilizers
Office Memorandum.
Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-
Remedies Ltd.
Udyog Bhawan,
New Dclhi,the 14th November,2012.
l4 Case of M/s Unimark
The undersigned is directed to refer to DGFT U.O.No. 01l82l50ll5l9l{Ml2lDEs-31269 dated the
O2lo5ll2 vide which an application from M/s Unimark Remedies Ltd was sent to this Department for fixation of
norms under para: 4.7 for the export of Montelukast Sodium. This department has examined the matter and the
following comments are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14-
S.No.
Import Item
1
MNT― VI― {2-(2-(3(S)-3-(2-(7-Chloro-2‐
QuinnOlinyl)Ethenyl)―
3-Hydroxypropyl)Phenyl)-2-Propanol
1.438
2 Diisopropylethylam ine
0.557
3 Methane Sulfonyl Chloride
0.474
4 Iolune
4.466
A.cetonitrile
1.545
6
MCA―VI(side chain)1-(MerCaptomethyl)‐ CyC10propanc
Acetic Acid
0.600
7 Sodium Methoxide
0.670
８
　
一
９
Activated Carbon
0.100
Ethyl Acetate
10.811
Ю
一
‐
１
一
‐
２
Hexane
7.145
Methanol
2.528
Di Methyl Formamide
0.891
N-Heptane
1.262
2. 
This issues with the approval of Director (Cost)'
(N.N.Ahtta)
Section Offlcer
Pl―Noll:ls
Directorate Gcneral of Foreign Trade,
躙
駐薔獄
『∬め,udyog BhaWaL New Ddh.

均
F. No.3501 1 /58212015-Pl (Norms)
Government of lndia
Shastri Bhawan, New Delhi,
Dated: March 10, 20'16
Office Memorandum
Sub: - Fixation of norms under para 4.7- Application of M/s Alembic Pharmaceuticals
Ltd
The undersigned is directed to refer to DGFT U.O. No. 01l82l5Ol00702lAM-
16/DES-3 /841 dated the 31/08/2015 vide which an application from M/s. Alembic
Pharmaceuticals Ltd was sent to this Department for fixation of norms against export of
Benzathine Benzyl Penicillin 2.4 Mega lnjections in 20 ml vials. 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 Director (Pharma lndustry)'
(Raj Kumar)
Phone:23071162
UsPi3-Pharma@nic.in
Directorate General of Fore19n Trade,
(shn M v singh,FttDO),
udyog Bhawan,New Delhi
Name of Export Products
Q uantity
Raw Material to
be imported
Quantity recommended.
Benzathine Penicillin 2.4
Mega lnjections in 20 ml
vials(each vial contains
24,00,000 units 
of
Benzathine Benzyl Penicillin
1 00 vials
Benzathine
Benzyl Penicillin
sterile
0.252 BOU
Asl" f- 9ign1

_    
怖辱れ
な
covernment Oilridi3
醗ぶ富
:津』1棚F∬選朧
,麒s
subiect Advsnca Aulhoria*on anpticetion fran Mit. Ealaii Amiaes Pvt' Ltd' for trE import of |av
materiai againc fie exporl of N'Ethyl*-Pyrrolilme'
{Advaffie Authorrzalaln No 31 1006557? dated' 04 08 2015}
ReI rJ.O No 01/82/050'01301'AM-16'DES-llll1352' dated 18'12'2015
M,5.Ba}airAmineePvt'Ltd.hasilbrniuedpfgssntapplicationl'iorltreirn@tolrawmabdal
againrt lhe Bxporl of N-Ethyt-?'Pyriohdone'
TheappllcetianhasbEenexsminsdandlheDepartfilefltr€commendsthe'olk'\,,irgnormsforthe
prese nl Advance Authorizalircn applicaiion
This i$guB$ f,,ltt'? iha aFprova! of competent aulhotiiy'
σ
AIIL稔蕊脱測職|
Tel N0 011-23381430
１
．
２

Government of India
Deptt. of Chemicals & petrochemicals
Shastri Bhawan, New Delhi
sub: Application from M/s Jainex speciarty chemicat. for fixation of
input/output norms.
M/s Jainex specialty chemicat have submitted present apptication
fixation of Input/output norms for the import of raw material for the
anufacture and export of Calcium Butyrate
Their application has been examined. The party has furnished
ils of manufacturing process. This Department recommends the
ng norms for the present licence application:
(」ASBIR SINGH)
Consultant
:
DGFT′ Udvoq B
1)
一Saレ
lhi
of C&Pc u,o. No.14010/16/2014-Ch.II
dated 13.6.2014
Butyric Acid
0.788kg
677
日橿雪
,11°
f ExpOrt
Qty.
Item of Import
Qty.
l kg

斗
ψ
F. No.3501 I I 44212011 -PI (Norms)
Government of India
Udyog Bhawan,
New Delhi,the22nd February, 2012.
Office Memorandum
14 Case
Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-
of M/s CIPLA LTD.
The undersigned is directed to refer to DGFT u.o.No. 011821501692lAML21DES-3/I200
dated the 22/9111 vide which an application from M/s CIPLA LTD was sent to this Department
for fixation of norms under para: 4.7 for the export of 19 EXPORT ITEM AS BELOW. This
department has examined the matter and the following comments are furnished under para4.7 of
Hand Book of Procedures (Vol.l) 2009-14:-
(l) Export Item No.l.
(2)
Export Item No.l.
Aerodini 100 mcg inhaler (200md) with 58 mcl aerosol valve and l9ml alumlru
Imports Proposel
1
Salbutamol
0.02gms
2.
3.
19 ml Aluminium Can
4.
0.48 mm OD Actuators with Dust CoversiCaps
5.
1,1,1,2 -tetrafl uoroethane (HFA I 3 4 A Propel I ant)
l8.20gms
and 19rnl al
can.
Imports Proposel
For export ofl No.Inhalcr
1
Salbutamol
0.02Ogms
2.
50 mcl Aerosol Valves
り
Ｄ
19 ml Alunliniurn Can
4.
0.48 mm OD Actuators with Dust CoversiCaps
5.
1, l, 1,2-tetrafluoroethane (HFA1 34A Propellant)
14.40gms
(3) Export Item No.3.
Beclometasona diproPionate
19ml aluminium can.
50mcg inhaler (200md) with 63 mcl aerosol valve and
Imports Proposel
For ex,o■ofl No.Inhaler
1
0.01gms
Export Item No.2.
Salbutumol 100mcg inhaler (200md) with 50 mcl aerosol valve and 19ml aluminium

ハ
(5)
2.
3.
19 ml Aluminium Can
4.
5.
l,l,l,2 -tetrafl uoro ethane (HFA 1 3 4,A' Propel lant)
17.749ms
6.
Ethanol
0.456gms
(4) Export ltem No.4.
Beclometasona dipropionate 100mcg inhaler (200md) with 63 mcl aerosol valve and
19ml aluminium can.
Imports Proposel
For export ofl No.Inhaler
1
0.02gms
つ
ん
3.
19 ml Aluminium Can
4.
く
υ
l,l,l,2 -tetrafl uoro ethane (HFA 1 3 4 A Propel lant)
17.288gms
6.
Ethanol
0.912gms
Export ltem No.5.
Beclometasona dipropionate 200mcg inhaler (200md) with 63 mcl aerosol valve and
19ml aluminium can.
Imports Proposel
For cxpo■ofl No.Inhdcr
1
0.04gms
2.
3.
19 ml Aluminium Can
4.
5.
l,l,l,2 -tetrafl uoro ethane (HFA 1 3 4 A Propel I ant)
16.37gms
6.
Ethanol
1.824gms
(6) Export Item No.6.
geclo*etasora dip.opionate 250mcg inhaler (200md) with 63 mcl aerosol valve and
19ml aluminium can.
Imports Proposel
For expo■ofl No.Inhdcr
1
0.05gms
2.
3.
19 ml Aluminium Can
4.
5.
l,l,l,2 -tetrafl uoro ethane (HFA I 3 4,A. P ropel lant)
15.90gms
6.
Ethanol
2.28gms

(8)
(7) Exnort Item No.7.
Budespray 200mcg HFA inhaler (200md) with 58 mcl aerosol valve and 19ml
aluminium can.
Imports Proposel
1
Budesonide
0.04gms
2.
3.
19 ml Aluminium Can
4.
5.
l,l,l,2 -tetrafl uoro ethane (HFA 1 3 44. Propellant)
18.2gms
Export Item No.8.
Budespray lOOmcg HFA inhaler (200md) with 58 mcl aerosol valve and 19ml
aluminium can.
Imports Proposel
1
Budesonide
0.02gms
2.
3.
19 ml Aluminium Can
4.
5,
1,1,1,2 -tetrafl uoro ethane (HFA 1 3 4 A Prope I lant)
18.2gms
Export Item No.9.
meterol i
valve and l4ml alummrum
Imports Proposel
1
Salmeterol
0.003gms
2.
3.
14 ml Aluminium Can
4.
5.
l,l,l,2 -tetrafl uoro ethane (HFA I 3 4 A Propel lant)
l2.5Ogms
6.
Ethanol
0.256gms
Salmeterol inhaler 25mce(120md) with 63 mcl aerosol valve and l4ml aluminium can.
(10) Export Item No.l0.
Fluticort plus -25mcg HFA inhaler (120md) with 63 mcl aerosol valve and 14ml
aluminium can.
Imnorts Proposel
1
Salmeterol
0.003gms
つ
４
Fluticasone Propionate
0.015gms
3.
(9)

4.
14 ml Aluminium Can
5。
6.
l,l,l,2 -tetrafl uoroethane (HFA 1 3 4,{ Propel lant)
12.5gms
7.
Ethanol
0.256gms
(11) Export Item No.11.
Fluticort plus-250mcg HFA inhaler (l20md) with 63 mcl aerosol valve and 14ml
aluminium can.
Imports Proposel
1
Salmeterol
0.003gms
つ
４
Fluticasone Propionate
0.03gms
3.
4.
14 ml Aluminium Can
5.
6.
l,l,l,2 -tetrafl uoroethane (HFA 1 3 4,{ Prope I lant)
12.5gms
7.
Ethanol
0.256gms
(12) Export Item No.12.
Fluticort plus-50mcg HFA inhaler (120md) with 63 mcl aerosol valve and l4ml
aluminium can.
Imports Proposel
1
Salmeterol
0.003gms
2.
Fluticasone Propionate
0.006gms
3.
4.
14 ml Aluminium Can
5。
6.
1,1,7,2 -tetrafl uoroethane (HFA 1 3 44. Propel I ant)
l2.5gms
7.
Ethanol
0.256gms
(13) Export Item No.13.
Beclomethasone dipropionate 50mcg and salbutamol 100mcg hnhaler (200md) with 50
mcl aerosol valve and 19ml aluminium can.
Imports Proposel
1
0.0lgms
つ
４
Salbutamol
0.02gms
3.
50 mcl Aerosol Valves
As per packing pol Cy
4.
19 ml Aluminium Can
As per packing pol Cy
5.
6.
1,1,1,2 -tetrafl uoroethane (HFA I 3 44. Propel I ant)
14.04gms
7.
Ethanol
0.36gms
⌒

・
（
(14) Export Item No.14.
Fluticasone propionate 50mcg inhaler (120md) with 63 mcl aerosol valve and l4ml
aluminium can.
Imports Proposel
1
Fluticasone propionate
0.006gms
2.
As per pack ng pol Cy
3.
14 ml Aluminium Can
As per pack ng pol Cy
4.
As per pack ng pol Cy
5.
l,l,l,2 -tetrafl uoroethane (HFA 1 3 4 A Propellant)
12.5gms
6.
Ethanol
0.256gms
(15) Export Item No.15.
Fluticasone propionate 125mcg inhaler (l20md) with 63 mcl aerosol valve and 14ml
aluminium can.
Imports Proposel
1
Fluticasone propionate
0.015gms
2.
3.
14 ml Aluminium Can
4.
ξ
υ
l,l,l,2-tetrafl uoroethane (HFA I 3 4A Propellant)
l2.5gms
6.
Ethanol
0.256gms
(1.6) Export Item No.l6.
Fluticasone propionate 250mcg inhaler (l20md) with 63 mcl aerosol valve and 14ml
aluminium can.
Imports Proposel
1
Fluticasone propionate
0.03gms
2.

tl
ヽ
　
　
（
3.
14 ml Aluminium Can
4.
5.
I,l,l,2-tetrafl uoroethane (HFA I 3 4A Propellant)
l2.5gms
6.
Ethanol
0.256gms
(17) Export Item No.17.
Formoterol fumarate inhaler l2mcg (120md) with 40 mcl aerosol valve and l0ml
aluminium can.
Imports Proposel
For export of l No.Inhalcr
1
Formoterol fumarate
0.0014gms
2.
40 mcl Aerosol Valves
3.
10 ml Aluminium Can
4.
5.
l,l,l,2 -tetrafl uoroethane (HFA 1 3 4A Propellant)
7.84gms
6.
Ethanol
0.16gms
(18) Export Item No.18.
Formoterol fumarate and budesonide inhaler 100/6mcg (l20md) with 58 mcl aerosol
valve and 19ml aluminium can.
Imnorts Proposel
1
Formoterol fumarate
0.0007gms
2.
Budesonide
0.012
3.
4.
19 ml Aluminium Can
As per packing po Cy
5.
As per packing pol Cy
6.
l,l,I,2-tetrafl uoroethane (HFA I 3 4A Propellant)
12.2gms
(19) Export ltem No.19.
Formoterol fumarate and budesonide inhaler 200l6mcg (120md) with 58 mcl aerosol
valve and l9ml aluminium can.
Imports Proposel
I
Formoterol fumarate
0.0007
2.
Budesonide
0.024gms
3.
4.
19 ml Aluminium Can
5.
6.
l,I,l,2-tetr afluoroethane (HFA I 3 4,A. Propellant)
12.2gms
7.
Ethanol
NIL
3. 
Above recommendations are subject to the condition that:-

',a
(a) Import of GFA 134A Propellant and its quantity is subject to NOC from MOEF.
(b) Requirement of HFA 134,A. Proopellant is inclusive of allowances for permissible
loss in weight on storge and priming losses.
(c) The firm will maintain separate record on HFA 134,{ Propellant import &
consumption.
4. 
This issues with the approval of Deputy Director General.
(N.N.Ahuja)
Section Officer
PI-NORMS
(Lalita Maini (Mrs), FTDO), Udyog Bhawan, New Delhi.

btg
F. No.350 1 1 1201 1201 6-Pl (Norms)
Government of lndia
Dated: August, 2016
Office Memorandum
Case of M/s Morepen Labs Ltd.
The undersigned is directed to refer to DGFT U.O.No. 0118215012211AM-17/DES-
31302 dated the 13ft116 vide which application from M/s Morepen Labs Ltd. was sent to
this Department for fixation of norms under para: 4.7 for the export of Atorvastatin
Calcium. 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. 
(Rajkumar)
PH:- 23071162
Udyog Bhawan, New Delhi.
S.No.
lmport item
Norms Recommended for
1kq Export
(4 R-cis)- 1, 1 -d i methyl ethyl-6-cya n ometh yl-2,2-
d imethyl-1, 3-d ioxane-4-acetate
0.708k9
2
4-fluoro-alpha-[2-methyl- 1 -oxop ropyl]-gamma-
oxo-N-beta-diphenyl benzene butanamide
0.994k9
3
Methanol
4.285kq
4
Methyl tert-butyl ether
1.145kq
5
Tetrahydrofuran
0.542kq
6
Methylene chloride
1.414kq
7
Diisopropyl ether
0.754kq

6n
F. No.3501 1/14012016-Pt (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 Royal pharma.
--- TheundersignedisdirectedtorefertoDGFTU.o.No.olt12lsot3lotAM-17/DES-
31229 dated lhe 617116 vide which application from wVs Royal pharma. was sent to this
Department for fixation of norms under para: 4.7 for the export of Bicalutamide sulfide.
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.
1
lmport item
Norms Recommended
for 1kg Export
N-[4-cyano-3-(trifluoromethyl) phenyt]
methacrylamide
0.709k9
つ
４
4-fluorothiophenol
0.32kg
2. 
Under secretary to the o"""r.r!T?t',Ti'l
PH:- 23071162
Udyog Bhawan, New Delhi.

ル
62「キ″
1  1むiζきヽも
:1'0アiう/82-ALё 4わbiJ
l   l
Patt Name:BALAJI AMINES
LIMITED
Mcet No/Date:21/82-
ALC4/2013
06022014
Lic.No/Date:3110060791
22102013
ion : ln the light of written comments received from Department of Chemicals and
:hemicals vide their U.O No. 1.4O1O1122/2011-Ch ll dated 13.02.20L4, it was decided to
norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm,
ever is less:
Export product
Exp.
Qty.
SI.No.
lmport items
Qty. allowed
GAMMA BUTYROLACTONE
l kg
1.
1、4 BUTANEDIOL
1.16 kg
2
GBL CATALYST
0.001 kg
may take appropriate action as per the decision of Norms Committee.

(tS t
F. No.350l 11468/2014-PI (Norms)
Govemment of India
Udyog Bhawan,
New Delhi, the February, 2015
Office Memorandum
Sub: Fixation of norms under para4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of
M/s. Atul Biosciences Ltd.
The undersigned is 
directed to refer to DGFT U.o.No.
011821501574,575,573/AM15/DES -31519,513,514 dated the 02109114 vide which an application
from M/s. Atul Biosciences Ltd was sent to this Department for fixation of norms undei para: 4.7
for the export of N-Benzyloxycarbonyl-L-Valin e (CBZ-L-VALINE). This department has
examined the matter and the following comments are fumished under para 4.7 of Hand Book of
Procedures (Vol.l) 2009 -l 4:-
S.No.
Import Item
1
L―Valine
0.510
2.
Heptane
0.44
This issues with the approval of Director (pl).
(Bamali Khastgir)
Under Secretary to the GoverIIment Oflndia
Phone-23071162
DircctOrate Gencra1 0fForeign Trade,
Department Of COmmerce,
(Shri M.V.Singh,FTDO),
Udyog Bhawan,New Delhi
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F.No.35011/577ノ2015‐PI(NOrlns)
GoVeF■ment Oflndia
Ministn'OfCherlliCal&Fertilizcrs
Departlnent OfPha口llaCcuticalS
New Delhi,the
Udyog Bhau'an-
December. 201 5
ヽu●cに―RXabn Of norlns under p     Of PF∝
eduFs α dl)2009■
4 Casc
Or MおFel,llentaBiotechtttd・
The undersigned is directed to referto DGFT U.0.No.01′
82メ50r775/AM‐ 16ノDES-3/836
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^11_ ^、.^_:_△■,h→m,ftpr and the following nollllS are
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ed me m農“
r ttd血個
bwhg nomS tte
nlHlished under para 4.7 ofHand B∞k Ofprocedures(VOl・1)2009‐ 141‐
(Raj Kumar)
Phone:23071 162
Sヽo
l.
ImPort Item
Cholesterol
qt1. R""oqry9nd9a|e/k$.
4.14
4
\{eth-v"l Formate
Petoleum Ether
6.25
0.362
1)irectOrale General ofFoFeign Trade,
D■artlnCIIt of,ommeⅢe,|
rSh轟M.V.Si五典,FTDO),
Uttog Bhaw彎,ド
'WP,lhti l 
′
This issues with the approval of competent authoriry'

F
Government of lndia
Ministry of Chenicals and Fertilizers
Department of Chemicals and Petrochemicals
びっ
SubieCt Advance Authottzation applicalon from M/s Clean Science and Technology Pvt.Ltd.
forthe import of raw matettal againstthe export of GUAIACOL 99%PURITY.
(Advance Authorization No.3110065713 dated 20.10.2015)
Ref:  U.O.No.01/82/050/1417/AM16/DES―
l‖/1552 dated 14.1.2016
A/1/s. Clean Science and Technology Pvt Ltd. have subnlitted present applicatiOns fOr
the import ofraw matettal againstthe export of GUAIACOL 99%PURITY.
The app‖ cation have been exanlined based on the addition inforrnation furnish by the
firrn. 丁he Department recornrnends the fo‖owihg norrns for the present Advanco Authorization
application.
Item of Export
Qtv.
Item of lmport
Qty
GUAIACOL 99%PURI丁Y
l kg.
1.PHENOXY METHANE/ANISOLE
(PURITY 93%MAXIMUM)
1.287 kg
2 HYDROGEN PEROXIDE(60%)
0.687 kg
3.ACETONE
0.270 kg
This issue with the approval of competent authority.
Addl.lndustrial Adviser
Tel.No.011-23381430
Deptt.of C&PC U.〇.No.14010/3/2012-CH― ||(Vol.-1)dated 16.2.2016
(AK.AGAR1/VAL)

_b
LW
F. No.350 I 1 15821201 4-Pl fillorms)
Governntent of India
Ministry of Chernicals & Fertilizers
Department of Pharmaceut icals
Udyog Bhawan.New Delhi.
Dated the 
MaY, 2015
Ofhge MerTrqr3ndu.m
## Subject: - Fixation of norms under para4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case
of M/s Honour Labs Ltd.
The undersigned is directed to refer to DGFT U.O.No. Oll82l50l67llAM-15/DES-3/860
dated the Z4lllll4 vide which application from M/s. Honour Labs Ltd was sent to this
Department for fixation of norms under para: 4.7 for the export of (2R'5S)-5-(4-amino-5-
fluoro-2-oxo-2H-pyrimidin-l-yl)-[1,3]oxathiolane-2-carboxylic 
acid-(1R,2S,5R)-methyl
ester. This department has examinia tn. matter and the following norms are furnished under
## para 4.7 of Hand Book of Procedures (Vol.l) 2009- l4:-
2. 
This issues with the approval of Director (PI).
(Barnali Khastgir)
Phone:23071 162
S. No.
Imporl ltem
1
5-Fluoro Cytosine
0.50
2.
Hexamethyl Disilazane
0.53
3.
lνlethane Sulfonic Acid
0.007

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