IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2016-09-07

DGFT Committee Minutes

Reliability

IN FORCE

In force — no superseding record on file.

Issuer: DGFT
Type: Committee Minutes
Committee / bench: Norms Committee — Pharmaceuticals (NC-III)
Date: 2016-09-07
Topic: Advance Authorisation
Official copy: Download source PDF ↗

Referenced in this document

Tariff

Chapter 29 Organic chemicals

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Chapter 30 Pharmaceutical products

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Policy

Para 4.7
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Amended 6× , last 2010-07-22.

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Para 4.07 ×20
FTP HBP

FTP 4.07 · Advance Authorisation for Annual Requirement and Eligibility Condition

- (i) Advance Authorisation for Annual Requirement shall only be issued for items notified in Standard Input Output Norms (SION). And it shall not be available in case of adhoc norms under paragraph 4.03 (b) (ii) of FTP. - (ii) Advance Authorisation for Annual Requirement shall also not be available in respect of SION where any item of input appears in Appendix 4-J. - (iii) Exporters having past export performance (in at least preceding two financial yea…

as published in CHAPTER 04 - DUTY EXEMPTION REMISSION SCHEMES

HBP 4.07 · Self-Declared Authorisations where SION does not exist

(i) Regional Authority may also issue Advance Authorisation where there is no SION/valid Ad hoc Norms for an export product or where SION / Ad hoc norms have been notified / published but exporter intends to use additional inputs in the manufacturing process, based on self-declaration by applicant. Wastage so claimed shall be subject to wastage norms as decided by Norms Committee. The applicant shall submit an undertaking to abide by decision of Norms Comm…

as published in CHAPTER 04 - DUTY EXEMPTION REMISSION SCHEMES

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Amended 3× , last 2023-07-17.

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Para 4.7.1 ×2

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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. 11/82/2016 of 2016-17 dated 07.09.2016 to consider the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products and falling under Chapter 29 and 30, held on 07.09.2016 under the Chairmanship of Shri J.V. Patil, Addl. DGFT in Room No.04, Udyog Bhawan, New Delhi. Following members were present:- Shri Nirmal Kumar, Dy. Director General of Foreign Trade Shri D.N.Mathur, Consultant, D/o Pharmaceuticals. The committee went through the minutes of earlier meeting No. 10/82 held 23.08.2016 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 : 11/82-ALC4/2016 MEETING DATE : 07.09.2016 1

Case No.:67/23/83-

ALC1/2012 Party Name:STERICON PHARMA PVT.LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Deferred HQ File :01/83/050/00467/AM13/ RLA File :07/24/040/00154/AM13/ Lic.No/Date:0710089457 04.07.2012 Defer Date: 16.11.2016 Decision :Deferred for want of comments from DoP. 2

Case No.:30/7/82-ALC4/2016 Party Name:NECTAR

LIFESCIENCES LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Deferred HQ File :01/82/050/00204/AM17/ RLA File :22/24/040/00069/AM14/ Lic.No/Date:2210014463 20.12.2013 Defer Date: 16.11.2016 Decision : The Committee noted that information called for from the firm by NC in its meeting No.07/82 dated 07.07.2016 is awaited. The Committee accordingly decided to await the reply from the firm and deferred the case. 3

Case No.:52/6/82-

ALC4/2014 Party Name:UPL LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00454/AM15/ RLA File :03/95/040/01043/AM14/ Lic.No/Date:0310776594 01.04.2014 Defer Date: 16.11.2016

2 Decision :Deferred. 4

Case No.:88/6/82-

ALC4/2014 Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00490/AM15/ RLA File :03/95/040/00033/AM15/ Lic.No/Date:0310782129 20.05.2014 Defer Date: 16.11.2016 Decision : Deferred. 5

Case No.:61/4/82-

ALC4/2014 Party Name:V & V PHARMA INDUSTRIES Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00309/AM15/ RLA File :03/95/040/00190/AM15/ Lic.No/Date:0310785305 13.06.2014 Defer Date: 16.11.2016 6

Case No.:73/9/82-

ALC4/2014 Party Name:D. R. COATS INK & RESINS PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00870/AM15/ RLA File :03/94/040/00755/AM14/ Lic.No/Date:0310786181 30.06.2014 Defer Date: 16.11.2016 7

Case No.:79/9/82-

ALC4/2014 Party Name:METROPOLITAN EXIMCHEM LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00876/AM15/ RLA File :03/95/040/00337/AM15/ Lic.No/Date:0310787073 18.07.2014 Defer Date: 16.11.2016 8

Case No.:41/8/82-ALC4/2014 Party Name:R L FINE CHEM Meet No/Date:11/82-

ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/00705/AM15/ RLA File :07/24/040/00130/AM15/ Lic.No/Date:0710105883 18.07.2014 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/326/2013-PI(Norms) dated 26.09.2013, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 9

Case No.:396/5/82-

ALC4/2015 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00536/AM16/ RLA File :17/24/040/00047/AM15/ Lic.No/Date:1710005887 24.07.2014 Defer Date: 16.11.2016 10

Case No.:63/8/82-

ALC4/2014 Party Name:ADCOCK INGRAM LTD, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00727/AM15/ RLA File :07/24/040/00148/AM15/ Lic.No/Date:0710106181 25.07.2014 Defer Date: 16.11.2016

3 Decision : The committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/107/2016-PI(Norms) dated August 2016, uploaded at the end of these minutes and deferred the case. 11

Case No.:32/9/82-

ALC4/2014 Party Name:CHEMCON SPECIALITY CHEMICALS P LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00829/AM15/ RLA File :34/24/040/00102/AM15/ Lic.No/Date:3410040406 28.07.2014 Defer Date: 16.11.2016 Decision : The Committee noted that information called for from the firm by NC in its meeting No.19/82 dated
18.03.2015 is awaited. The Committee accordingly decided to await the reply from the firm and deferred the case. 12

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

INDUSTRIES Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Deferred HQ File :01/82/050/00410/AM15/ RLA File :03/95/040/00331/AM15/ Lic.No/Date:0310787382 28.07.2014 Defer Date: 16.11.2016 Decision :Deferred. 13

Case No.:49/9/82-ALC4/2014 Party Name:SANMAR

SPECIALITY CHEMICALS LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/00846/AM15/ RLA File :04/24/040/00106/AM15/ Lic.No/Date:0410159125 01.08.2014 Defer Date: Decision : The Committee decided to ratify norms on repeat 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. 14

Case No.:31/9/82-

ALC4/2014 Party Name:AMBERNATH ORGANICS PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00828/AM15/ RLA File :03/94/040/00074/AM15/ Lic.No/Date:0310787610 04.08.2014 Defer Date: 16.11.2016 Decision :Deferred. 15

Case No.:2/14/82-

ALC4/2015 Party Name:SHREE SHIVSHANKAR DRUGS & PHARMACEUTICALS P. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01138/AM16/ RLA File :03/95/040/00425/AM15/ Lic.No/Date:0310788055 14.08.2014 Defer Date: 16.11.2016 Decision :Deferred for want of comment from DoP. 16

Case No.:48/5/82-

ALC4/2015 Party Name:VISION DRUGS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00188/AM16/ RLA File :09/24/040/00260/AM15/ Lic.No/Date:0910060860 18.08.2014 Defer Date: 16.11.2016 Decision : The Committee noted that information called for from the firm by NC in its meeting No.03/82 dated 12.05.2016 is awaited. The Committee accordingly decided to await the reply from

4 the firm and deferred the case. 17

Case No.:215/13/82-

ALC4/2014 Party Name:GOLD STAR CHEMICALS PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01218/AM15/ RLA File :03/94/040/00358/AM15/ Lic.No/Date:0310788338 25.08.2014 Defer Date: 16.11.2016 18

Case No.:377/5/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Deferred HQ File :01/82/050/00517/AM16/ RLA File :03/94/040/00493/AM15/ Lic.No/Date:0310788472 27.08.2014 Defer Date: 16.11.2016 Decision : Deferred for want of comments from DoP. 19

Case No.:224/13/82-

ALC4/2014 Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01227/AM15/ RLA File :03/94/040/00391/AM15/ Lic.No/Date:0310788515 28.08.2014 Defer Date: 16.11.2016 Decision :Deferred. 20

Case No.:225/13/82-

ALC4/2014 Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01228/AM15/ RLA File :03/94/040/00397/AM15/ Lic.No/Date:0310788514 28.08.2014 Defer Date: 16.11.2016 Decision :Deferred. 21

Case No.:262/13/82-

ALC4/2014 Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01265/AM15/ RLA File :03/94/040/00971/AM14/ Lic.No/Date:0310788560 01.09.2014 Defer Date: 16.11.2016 Decision :Deferred. 22

Case No.:223/13/82-

ALC4/2014 Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01226/AM15/ RLA File :03/94/040/00508/AM15/ Lic.No/Date:0310788647 02.09.2014 Defer Date: 16.11.2016 Decision :Deferred. 23

Case No.:3/7/82-ALC4/2014 Party Name:S V CHEM

INTERMEDIATES P LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00647/AM15/ RLA File :04/24/040/00139/AM15/ Lic.No/Date:0410159328 02.09.2014 Defer Date: 16.11.2016 Decision :Deferred. 24 Case No.:400/5/82- Party Name:YASH Meet No/Date:11/82- Status:Deferred

5 ALC4/2015 RASAYAN & CHEMICALS ALC4/2016 07.09.2016 HQ File :01/82/050/00540/AM16/ RLA File :34/24/040/00120/AM15/ Lic.No/Date:3410040554 15.09.2014 Defer Date: 16.11.2016 Decision :Deferred. 25

Case No.:12/15/82-

ALC4/2014 Party Name:JINDAL DRUGS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01299/AM15/ RLA File :03/94/040/00460/AM15/ Lic.No/Date:0310789265 16.09.2014 Defer Date: 16.11.2016 Decision :Deferred. 26

Case No.:15/13/82-

ALC4/2014 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01018/AM15/ RLA File :34/24/040/00161/AM15/ Lic.No/Date:3410040594 30.09.2014 Defer Date: 16.11.2016 Decision :Deferred. 27

Case No.:19/1/82-

ALC4/2015 Party Name:GEM AROMATICS PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01545/AM15/ RLA File :03/94/040/00594/AM15/ Lic.No/Date:0310789922 01.10.2014 Defer Date: 16.11.2016 Decision :Deferred. 28

Case No.:29/13/82-

ALC4/2014 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01032/AM15/ RLA File :05/23/040/00268/AM15/ Lic.No/Date:0510391490 08.10.2014 Defer Date: 16.11.2016 Decision :Deferred. 29

Case No.:124/13/82-

ALC4/2014 Party Name:PANACEA BIOTEC LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01127/AM15/ RLA File :05/24/040/00319/AM15/ Lic.No/Date:0510391623 17.10.2014 Defer Date: 16.11.2016 Decision : The Committee noted that information called for from the firm by NC in its meeting No.03/82 dated 12.05.2016 is awaited. The Committee accordingly decided to await the reply from the firm and deferred the case. 30

Case No.:198/5/82-

ALC4/2015 Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00338/AM16/ RLA File :04/24/040/00205/AM15/ Lic.No/Date:0410159704 11.11.2014 Defer Date: 16.11.2016 Decision : The Committee noted that information has been called for from the firm in NC meeting No.07/82 dated 07.07.2016 is awaited. The Committee decided to await the reply and deferred the case.

6 31

Case No.:126/8/82-

ALC4/2015 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00922/AM16/ RLA File :03/94/040/00710/AM15/ Lic.No/Date:0310791177 18.11.2014 Defer Date: 16.11.2016 Decision :Deferred. 32

Case No.:43/18/82-

ALC4/2014 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01409/AM15/ RLA File :03/95/040/00701/AM15/ Lic.No/Date:0310791419 26.11.2014 Defer Date: 16.11.2016 Decision :Deferred. 33

Case No.:145/5/82-

ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00285/AM16/ RLA File :03/94/040/00877/AM15/ Lic.No/Date:0310792112 17.12.2014 Defer Date: 16.11.2016 Decision :Deferred. 34

Case No.:127/5/82-

ALC4/2015 Party Name:EMAMI LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00267/AM16/ RLA File :02/24/040/00183/AM15/ Lic.No/Date:0210205355 18.12.2014 Defer Date: 16.11.2016 Decision :Deferred for want of comments from MSME. 35

Case No.:136/5/82-

ALC4/2015 Party Name:AVIGNON EXIM PVT.LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/00276/AM16/ RLA File :03/94/040/00843/AM15/ Lic.No/Date:0310792314 23.12.2014 Defer Date:
Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.34/82 dated 23.11.2010, 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. 36

Case No.:221/5/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00361/AM16/ RLA File :09/24/040/00537/AM15/ Lic.No/Date:0910061442 23.12.2014 Defer Date: 16.11.2016 Decision :Deferred 37

Case No.:114/5/82-

ALC4/2015 Party Name:NATIONAL TUBE INDUSTRIES, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Deferred HQ File :01/82/050/00254/AM16/ RLA File :03/95/040/00756/AM15/ Lic.No/Date:0310792363 24.12.2014 Defer Date: 16.11.2016 Decision :Copy of application has been sent to MSME for comments. The Committee decided await the reply and deferred the case.

7 38

Case No.:218/5/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00358/AM16/ RLA File :09/24/040/00552/AM15/ Lic.No/Date:0910061462 29.12.2014 Defer Date: 16.11.2016 Decision :Deferred. 39

Case No.:99/18/82-

ALC4/2014 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01465/AM15/ RLA File :07/24/040/00302/AM15/ Lic.No/Date:0710107307 30.12.2014 Defer Date: 16.11.2016 40

Case No.:111/18/82-

ALC4/2014 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01477/AM15/ RLA File :07/24/040/00307/AM15/ Lic.No/Date:0710107306 30.12.2014 Defer Date: 16.11.2016 41

Case No.:45/5/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00185/AM16/ RLA File :09/24/040/00558/AM15/ Lic.No/Date:0910061483 05.01.2015 Defer Date: 16.11.2016 42

Case No.:102/5/82-

ALC4/2015 Party Name:ALTA LABORATORIES LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00242/AM16/ RLA File :03/94/040/00836/AM15/ Lic.No/Date:0310792635 07.01.2015 Defer Date: 16.11.2016 43

Case No.:74/5/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00214/AM16/ RLA File :03/95/040/00833/AM15/ Lic.No/Date:0310792647 07.01.2015 Defer Date: 16.11.2016 44

Case No.:149/5/82-

ALC4/2015 Party Name:ALCHEMIE LABORATORIES Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00289/AM16/ RLA File :03/94/040/00813/AM15/ Lic.No/Date:0310792673 08.01.2015 Defer Date: 16.11.2016 45 Case No.:219/5/82- ALC4/2015 Party Name:BHAGIRADHA CHEMICALS & Meet No/Date:11/82- ALC4/2016 Status:Deferred

8 INDUSTRIES LIMITED 07.09.2016 HQ File :01/82/050/00359/AM16/ RLA File :09/24/040/00549/AM15/ Lic.No/Date:0910061517 09.01.2015 Defer Date: 16.11.2016 Decision :Deferred. 46

Case No.:112/5/82-

ALC4/2015 Party Name:UNIMAX CHEMICALS PVT LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00252/AM16/ RLA File :03/95/040/00812/AM15/ Lic.No/Date:0310793039 19.01.2015 Defer Date: 16.11.2016 Decision : The Committee noted that an investigation in the matter is under process. The Committee accordingly, decided to defer the case. 47

Case No.:88/5/82-

ALC4/2015 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00228/AM16/ RLA File :05/23/040/00486/AM15/ Lic.No/Date:0510392949 21.01.2015 Defer Date: 16.11.2016 Decision : Deferred for want of comments from AYUSH 48

Case No.:138/8/82-

ALC4/2015 Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00934/AM16/ RLA File :03/94/040/01099/AM14/ Lic.No/Date:0310793426 30.01.2015 Defer Date: 16.11.2016 Decision : Information called for from the firm in NC meeting No.18/82 dated 10.02.2016 is awaited. The committee decided to await the reply and deferred the case. 49

Case No.:275/5/82-

ALC4/2015 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00415/AM16/ RLA File :03/94/040/00930/AM15/ Lic.No/Date:0310793539 03.02.2015 Defer Date: 16.11.2016 Decision :Deferred. 50

Case No.:133/7/82-

ALC4/2016 Party Name:SIRMAXO CHEMICALS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00307/AM17/ RLA File :03/95/040/00911/AM15/ Lic.No/Date:0310793837 12.02.2015 Defer Date: 16.11.2016 Decision : Information 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. 51

Case No.:285/5/82-

ALC4/2015 Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00425/AM16/ RLA File :03/94/040/01092/AM15/ Lic.No/Date:0310793985 19.02.2015 Defer Date: 16.11.2016 Decision :Deferred. 52 Case No.:279/5/82- ALC4/2015 Party Name:CROWN CHEMICALS PVT.LTD., Meet No/Date:11/82- ALC4/2016 Status:Deferred

9 07.09.2016 HQ File :01/82/050/00419/AM16/ RLA File :03/94/040/01088/AM15/ Lic.No/Date:0310793983 19.02.2015 Defer Date: 16.11.2016 Decision :Deferred. 53

Case No.:288/5/82-

ALC4/2015 Party Name:CROWN CHEMICALS PVT.LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00428/AM16/ RLA File :03/94/040/01089/AM15/ Lic.No/Date:0310793982 19.02.2015 Defer Date: 16.11.2016 54

Case No.:335/5/82-

ALC4/2015 Party Name:PRIVI ORGANICS LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00475/AM16/ RLA File :03/95/040/00978/AM15/ Lic.No/Date:0310794038 20.02.2015 Defer Date: 16.11.2016 55

Case No.:334/5/82-

ALC4/2015 Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00474/AM16/ RLA File :03/95/040/00862/AM15/ Lic.No/Date:0310794100 24.02.2015 Defer Date: 16.11.2016 56

Case No.:309/5/82-

ALC4/2015 Party Name:SHREE VALLABH CHEMICAL Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00449/AM16/ RLA File :08/24/040/00417/AM15/ Lic.No/Date:0810134670 25.02.2015 Defer Date: 16.11.2016 57

Case No.:273/5/82-

ALC4/2015 Party Name:BHARAT SERUMS & VACCINES LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00413/AM16/ RLA File :03/94/040/01055/AM15/ Lic.No/Date:0310794262 27.02.2015 Defer Date: 16.11.2016 Decision : Deferred for want of comments from DBT. 58

Case No.:452/5/82-

ALC4/2015 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00592/AM16/ RLA File :03/94/040/01091/AM15/ Lic.No/Date:0310794261 27.02.2015 Defer Date: 16.11.2016 59

Case No.:295/5/82-

ALC4/2015 Party Name:PROLIFE INDUSTRIES LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00435/AM16/ RLA File :08/24/040/00395/AM15/ Lic.No/Date:0810134703 03.03.2015 Defer Date: 16.11.2016

10 60

Case No.:303/5/82-

ALC4/2015 Party Name:ASSOCIATED DYESTUFF PVT. LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00443/AM16/ RLA File :08/24/040/00422/AM15/ Lic.No/Date:0810134739 05.03.2015 Defer Date: 16.11.2016 61

Case No.:402/5/82-

ALC4/2015 Party Name:POLYDRUG LABORATORIES PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/00542/AM16/ RLA File :03/95/040/01024/AM15/ Lic.No/Date:0310794467 10.03.2015 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/418/2015- 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. 62

Case No.:300/5/82-

ALC4/2015 Party Name:ADVANCE PETROCHEMICALS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00440/AM16/ RLA File :08/24/040/00448/AM15/ Lic.No/Date:0810134768 11.03.2015 Defer Date: 16.11.2016 Decision :Deferred. 63

Case No.:447/5/82-

ALC4/2015 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00587/AM16/ RLA File :03/94/040/01131/AM15/ Lic.No/Date:0310794543 12.03.2015 Defer Date: 16.11.2016 Decision :Copy of application has been sent to DoP for comments. 64

Case No.:45/4/82-

ALC4/2015 Party Name:TIDE INDUSTRIES Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00084/AM16/ RLA File :34/24/040/00325/AM15/ Lic.No/Date:3410041050 16.03.2015 Defer Date: 16.11.2016 Decision :Deferred. 65

Case No.:291/5/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00431/AM16/ RLA File :05/23/040/00544/AM15/ Lic.No/Date:0510393616 18.03.2015 Defer Date: 16.11.2016 Decision :Deferred. 66

Case No.:183/5/82-

ALC4/2015 Party Name:SPAK ORGOCHEM (INDIA) PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File RLA File Lic.No/Date:0310794811 Defer Date:

11 :01/82/050/00323/AM16/ :03/95/040/00964/AM15/ 23.03.2015 16.11.2016 Decision :Deferred. 67

Case No.:29/5/82-

ALC4/2015 Party Name:ASSOCIATED DYESTUFF PVT. LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 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: 16.11.2016 Decision :Deferred. 68

Case No.:26/5/82-

ALC4/2015 Party Name:CONTINENTAL CHEMICALS Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00166/AM16/ RLA File :08/24/040/00470/AM15/ Lic.No/Date:0810134992 07.04.2015 Defer Date: 16.11.2016 Decision :Deferred. 69

Case No.:35/5/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00175/AM16/ RLA File :09/24/040/00739/AM15/ Lic.No/Date:0910061891 17.04.2015 Defer Date: 16.11.2016 Decision : Copy of application has been sent to DoP. 70

Case No.:132/7/82-

ALC4/2015 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00737/AM16/ RLA File :03/94/040/00024/AM16/ Lic.No/Date:0310795429 20.04.2015 Defer Date: 16.11.2016 Decision : Information called for from the firm in NC meeting No.07/82 dated 07.07.2016 is awaited. The Committee accordingly deferred the case. 71

Case No.:40/8/82-

ALC4/2015 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 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: 16.11.2016 Decision :Deferred. 72

Case No.:174/5/82-

ALC4/2015 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00314/AM16/ RLA File :07/24/040/00393/AM15/ Lic.No/Date:0710108142 01.05.2015 Defer Date: 16.11.2016 Decision :Deferred. 73

Case No.:176/5/82-

ALC4/2015 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00316/AM16/ RLA File :07/24/040/00389/AM15/ Lic.No/Date:0710108141 01.05.2015 Defer Date: 16.11.2016 Decision :Deferred.

12 74

Case No.:177/5/82-

ALC4/2015 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00317/AM16/ RLA File :07/24/040/00390/AM15/ Lic.No/Date:0710108143 01.05.2015 Defer Date: 16.11.2016 Decision :Deferred. 75

Case No.:75/8/82-

ALC4/2015 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00871/AM16/ RLA File :09/24/040/00051/AM16/ Lic.No/Date:0910061986 06.05.2015 Defer Date: 16.11.2016 Decision : The Committee noted that Information has been called for from the firm in NC meeting No.20 dated 09.03.2016 is awaited. The Committee accordingly deferred the case. 76

Case No.:65/8/82-

ALC4/2015 Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00861/AM16/ RLA File :09/24/040/00052/AM16/ Lic.No/Date:0910061973 06.05.2015 Defer Date: 16.11.2016 Decision : The Committee noted that Information has been called for from the firm in NC meeting No.03 dated 12.05.2016 is awaited. The Committee accordingly deferred the case. 77

Case No.:7/5/82-ALC4/2015 Party Name:JODAS EXPOIM

PVT.LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00147/AM16/ RLA File :05/23/040/00037/AM16/ Lic.No/Date:0510394177 08.05.2015 Defer Date: 16.11.2016 Decision : The Committee noted that Information has been called for from the firm in NC meeting No.03 dated 12.05.2016 is awaited. The Committee accordingly deferred the case. 78

Case No.:97/8/82-

ALC4/2015 Party Name:ASCENT FINECHEM PVT. LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00893/AM16/ RLA File :08/24/040/00051/AM16/ Lic.No/Date:0810135338 22.05.2015 Defer Date: 16.11.2016 Decision :Deferred. 79

Case No.:45/8/82-

ALC4/2015 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00841/AM16/ RLA File :05/24/040/00073/AM16/ Lic.No/Date:0510394342 25.05.2015 Defer Date: 16.11.2016 Decision : The Committee noted that Information has been called for from the firm in NC meeting No.20 dated 09.03.2016 is awaited. The Committee accordingly deferred the case. 80 Case No.:86/8/82- Party Name:VIVIMED LABS Meet No/Date:11/82- Status:Deferred

13 ALC4/2015 LIMITED ALC4/2016 07.09.2016 HQ File :01/82/050/00882/AM16/ RLA File :09/24/040/00131/AM16/ Lic.No/Date:0910062091 29.05.2015 Defer Date: 16.11.2016 Decision :Deferred. 81

Case No.:187/7/82-

ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00792/AM16/ RLA File :08/24/040/00057/AM16/ Lic.No/Date:0810135435 05.06.2015 Defer Date: 16.11.2016 Decision :Deferred. 82

Case No.:121/8/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00917/AM16/ RLA File :03/95/040/00190/AM16/ Lic.No/Date:0310796766 23.06.2015 Defer Date: 16.11.2016 Decision :Deferred. 83

Case No.:41/7/82-

ALC4/2016 Party Name:DEEPAK NITRITE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00215/AM17/ RLA File :34/24/040/00082/AM16/ Lic.No/Date:3410041319 24.06.2015 Defer Date: 16.11.2016 Decision :Deferred. 84

Case No.:89/7/82-

ALC4/2015 Party Name:HALDIA PETROCHEMICALS LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00694/AM16/ RLA File :02/24/040/00045/AM16/ Lic.No/Date:0210205925 26.06.2015 Defer Date: 16.11.2016 Decision :Deferred. 85

Case No.:97/14/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01233/AM16/ RLA File :09/24/040/00186/AM16/ Lic.No/Date:0910062271 01.07.2015 Defer Date: 16.11.2016 Decision :Deferred. 86

Case No.:109/14/82-

ALC4/2015 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01245/AM16/ RLA File :09/24/040/00195/AM16/ Lic.No/Date:0910062283 02.07.2015 Defer Date: 16.11.2016 Decision :Deferred. 87

Case No.:54/8/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File RLA File Lic.No/Date:0510394862 Defer Date:

14 :01/82/050/00850/AM16/ :05/23/040/00150/AM16/ 09.07.2015 16.11.2016 Decision : The Committee noted that Information has been called for from the firm in NC meeting No.03 dated 12.05.2016 is awaited. The Committee accordingly deferred the case. 88

Case No.:50/8/82-

ALC4/2015 Party Name:PUSILIN BIOTECHNOLOGY PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00846/AM16/ RLA File :06/24/040/00014/AM16/ Lic.No/Date:0610038189 09.07.2015 Defer Date: 16.11.2016 Decision :Deferred. 89

Case No.:54/14/82-

ALC4/2015 Party Name:BIOLOGICAL E LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01190/AM16/ RLA File :09/24/040/00524/AM15/ Lic.No/Date:0910062332 15.07.2015 Defer Date: 16.11.2016 meeting No.03 dated 12.05.2016 is awaited. The Committee decided to await the reply 90

Case No.:59/14/82-

ALC4/2015 Party Name:BIOLOGICAL E LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01195/AM16/ RLA File :09/24/040/00525/AM15/ Lic.No/Date:0910062331 15.07.2015 Defer Date: 16.11.2016 meeting No.03 dated 12.05.2016 is awaited. The Committee decided to await the reply 91

Case No.:41/14/82-

ALC4/2015 Party Name:DEEPAK NITRITE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01177/AM16/ RLA File :34/24/040/00031/AM16/ Lic.No/Date:3410041376 15.07.2015 Defer Date: 16.11.2016 Decision :Deferred. 92

Case No.:49/8/82-

ALC4/2015 Party Name:M.L.A. INDUSTRIES Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00845/AM16/ RLA File :06/24/040/00015/AM16/ Lic.No/Date:0610038193 16.07.2015 Defer Date: 16.11.2016 Decision :Deferred. 93

Case No.:120/8/82-

ALC4/2015 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00916/AM16/ RLA File :03/95/040/00304/AM16/ Lic.No/Date:0310797293 16.07.2015 Defer Date: 16.11.2016 Decision :Deferred.

15 94

Case No.:49/14/82-

ALC4/2015 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01185/AM16/ RLA File :09/24/040/00205/AM16/ Lic.No/Date:0910062344 17.07.2015 Defer Date: 16.11.2016 Decision :Deferred. 95

Case No.:39/14/82-

ALC4/2015 Party Name:JAGSONPAL PHARMACEUTICALS LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01175/AM16/ RLA File :05/23/040/00165/AM16/ Lic.No/Date:0510395004 20.07.2015 Defer Date: 16.11.2016 meeting No.07 dated 07.07.2016 is awaited. The Committee decided to await the reply 96

Case No.:21/16/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01341/AM16/ RLA File :09/24/040/00223/AM16/ Lic.No/Date:0910062361 22.07.2015 Defer Date: 16.11.2016 meeting No.05 dated 08.06.2016 is awaited. The Committee decided to await the reply 97

Case No.:149/14/82-

ALC4/2015 Party Name:VISION DRUGS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01285/AM16/ RLA File :09/24/040/00230/AM16/ Lic.No/Date:0910062365 23.07.2015 Defer Date: 16.11.2016 meeting No.03 dated 12.05.2016 is awaited. The Committee decided to await the reply 98

Case No.:1/10/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 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: 16.11.2016 Decision :Deferred. 99

Case No.:170/14/82-

ALC4/2015 Party Name:PI INDUSTRIES LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/01306/AM16/ RLA File :13/24/040/00015/AM16/ Lic.No/Date:1310047932 29.07.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O.No.15022/6/2010-Ch-II dated 10.08.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.
RA concerned may take necessary action as per decision of NC. 100 Case No.:131/14/82- Party Name:SALICYLATES Meet No/Date:11/82- Status:Deferred

16 ALC4/2015 & CHEMICALS PRIVATE LIMITED ALC4/2016 07.09.2016 HQ File :01/82/050/01267/AM16/ RLA File :09/24/040/00212/AM16/ Lic.No/Date:0910062413 30.07.2015 Defer Date: 16.11.2016 Decision :Deferred. 101

Case No.:60/14/82-

ALC4/2015 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01196/AM16/ RLA File :09/24/040/00256/AM16/ Lic.No/Date:0910062418 31.07.2015 Defer Date: 16.11.2016 Decision :Deferred. 102

Case No.:84/1/82-

ALC1/2016 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01858/AM16/ RLA File :08/91/040/00210/AM16/ Lic.No/Date:0810135770 03.08.2015 Defer Date: 16.11.2016 103

Case No.:169/14/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01305/AM16/ RLA File :31/83/040/00018/AM16/ Lic.No/Date:3110065573 03.08.2015 Defer Date: 16.11.2016 Decision :Deferred. 104

Case No.:17/8/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00813/AM16/ RLA File :09/24/040/00251/AM16/ Lic.No/Date:0910062426 03.08.2015 Defer Date: 16.11.2016 Decision :Deferred. 105

Case No.:168/14/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01304/AM16/ RLA File :31/83/040/00024/AM16/ Lic.No/Date:3110065579 04.08.2015 Defer Date: 16.11.2016 Decision :Deferred. 106

Case No.:18/14/82-

ALC4/2015 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01154/AM16/ RLA File :03/95/040/00317/AM16/ Lic.No/Date:0310798039 10.08.2015 Defer Date: 16.11.2016 Decision :Deferred. 107

Case No.:115/16/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred

17 HQ File :01/82/050/01435/AM16/ RLA File :03/95/040/00164/AM16/ Lic.No/Date:0310798051 10.08.2015 Defer Date: 16.11.2016 meeting No.07 dated 07.07.2016 is awaited. The Committee decided to await the reply 108

Case No.:23/8/82-

ALC4/2015 Party Name:ALPHAMED FORMULATIONS P LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00819/AM16/ RLA File :09/24/040/00091/AM16/ Lic.No/Date:0910062478 11.08.2015 Defer Date: 16.11.2016 109

Case No.:155/14/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01291/AM16/ RLA File :05/24/040/00237/AM16/ Lic.No/Date:0510395271 11.08.2015 Defer Date: 16.11.2016 110

Case No.:11/18/82-

ALC4/2015 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01476/AM16/ RLA File :03/95/040/00327/AM16/ Lic.No/Date:0310798117 13.08.2015 Defer Date: 16.11.2016 Decision :Deferred. 111

Case No.:34/14/82-

ALC4/2015 Party Name:TRANSPEK INDUSTRY LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01170/AM16/ RLA File :34/24/040/00144/AM16/ Lic.No/Date:3410041464 17.08.2015 Defer Date: 16.11.2016 112

Case No.:99/14/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01235/AM16/ RLA File :09/24/040/00231/AM16/ Lic.No/Date:0910062516 18.08.2015 Defer Date: 16.11.2016 meeting No20/82 dated 09.03.2016 is awaited. The Committee decided to await the reply 113

Case No.:56/13/82-

ALC4/2015 Party Name:PANACEA BIOTEC LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01019/AM16/ RLA File :05/24/040/00183/AM16/ Lic.No/Date:0510395354 18.08.2015 Defer Date: 16.11.2016

18 114

Case No.:154/14/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01290/AM16/ RLA File :05/24/040/00381/AM15/ Lic.No/Date:0510395357 19.08.2015 Defer Date: 16.11.2016 Decision :Deferred. 115

Case No.:68/14/82-

ALC4/2015 & CHEMICALS PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01204/AM16/ RLA File :09/24/040/00368/AM15/ Lic.No/Date:0910062518 19.08.2015 Defer Date: 16.11.2016 Decision :Deferred. 116

Case No.:24/14/82-

ALC4/2015 Party Name:SHUBHAM SPECIALTY PRODUCTS Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01160/AM16/ RLA File :03/95/040/00348/AM16/ Lic.No/Date:0310798516 27.08.2015 Defer Date: 16.11.2016 Decision :Deferred. 117

Case No.:82/14/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01218/AM16/ RLA File :05/24/040/00233/AM16/ Lic.No/Date:0510395480 31.08.2015 Defer Date: 16.11.2016 Decision :Deferred. 118

Case No.:89/14/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01225/AM16/ RLA File :05/24/040/00224/AM16/ Lic.No/Date:0510395479 31.08.2015 Defer Date: 16.11.2016 Decision :Deferred. 119

Case No.:94/14/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01230/AM16/ RLA File :05/24/040/00202/AM16/ Lic.No/Date:0510395481 31.08.2015 Defer Date: 16.11.2016 Decision :Deferred. 120

Case No.:116/16/82-

ALC4/2015 Party Name:PANERA BIOTEC PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01436/AM16/ RLA File :05/24/040/00181/AM16/ Lic.No/Date:0510395496 01.09.2015 Defer Date: 16.11.2016 Decision : Deferred for want of comments from DBT.

19 121

Case No.:93/14/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01229/AM16/ RLA File :05/24/040/00244/AM16/ Lic.No/Date:0510395493 01.09.2015 Defer Date: 16.11.2016 meeting No.05 dated 08.06.2016 is awaited. The Committee decided to await the reply 122

Case No.:124/7/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00298/AM17/ RLA File :03/94/040/00424/AM16/ Lic.No/Date:0310798671 04.09.2015 Defer Date: 16.11.2016 123

Case No.:59/11/82-

ALC4/2016 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00593/AM17/ RLA File :52/24/040/00040/AM16/ Lic.No/Date:5210041626 04.09.2015 Defer Date: Decision :Deferred. 124

Case No.:141/14/82-

ALC4/2015 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01277/AM16/ RLA File :17/24/040/00050/AM16/ Lic.No/Date:1710006170 04.09.2015 Defer Date: 16.11.2016 Decision :Deferred. 125

Case No.:52/14/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01188/AM16/ RLA File :09/24/040/00323/AM16/ Lic.No/Date:0910062554 04.09.2015 Defer Date: 16.11.2016 126

Case No.:56/14/82-

ALC4/2015 & CHEMICALS PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01192/AM16/ RLA File :09/24/040/00134/AM16/ Lic.No/Date:0910062560 08.09.2015 Defer Date: 16.11.2016 Decision :Deferred. 127

Case No.:124/16/82-

ALC4/2015 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred

20 HQ File :01/82/050/01444/AM16/ RLA File :03/94/040/00399/AM16/ Lic.No/Date:0310798771 09.09.2015 Defer Date: 16.11.2016 Decision :Deferred. 128

Case No.:46/14/82-

ALC4/2015 Party Name:MALWA OXYGEN & INDUSTRIAL GASES PVT.LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01182/AM16/ RLA File :56/24/040/00005/AM16/ Lic.No/Date:5610004674 09.09.2015 Defer Date: 16.11.2016 Decision :Deferred. 129

Case No.:53/14/82-

ALC4/2015 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01189/AM16/ RLA File :09/24/040/00315/AM16/ Lic.No/Date:0910062581 09.09.2015 Defer Date: 16.11.2016 130

Case No.:157/14/82-

ALC4/2015 Party Name:AETHER INDUSTRIES LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 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: 16.11.2016 Decision :Deferred. 131

Case No.:9/16/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01329/AM16/ RLA File :09/24/040/00328/AM16/ Lic.No/Date:0910062593 11.09.2015 Defer Date: 16.11.2016 meeting No.05 dated 08.06.2016 is awaited. The Committee decided to await the reply 132

Case No.:56/16/82-

ALC4/2015 INDUSTRIES PRIVATE LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01376/AM16/ RLA File :03/94/040/00435/AM16/ Lic.No/Date:0310798876 14.09.2015 Defer Date: 16.11.2016 Decision :Deferred. 133

Case No.:8/14/82-

ALC4/2015 Party Name:PRIVI ORGANICS LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01144/AM16/ RLA File :03/95/040/00343/AM16/ Lic.No/Date:0310798846 14.09.2015 Defer Date: 16.11.2016 Decision :Deferred. 134 Case No.:110/14/82- ALC4/2015 & CHEMICALS PRIVATE Meet No/Date:11/82- ALC4/2016 Status:Deferred

21 LIMITED 07.09.2016 HQ File :01/82/050/01246/AM16/ RLA File :09/24/040/00305/AM16/ Lic.No/Date:0910062601 14.09.2015 Defer Date: 16.11.2016 Decision :Deferred. 135

Case No.:134/14/82-

ALC4/2015 & CHEMICALS PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01270/AM16/ RLA File :09/24/040/00273/AM16/ Lic.No/Date:0910062602 14.09.2015 Defer Date: 16.11.2016 Decision :Deferred. 136

Case No.:7/14/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01143/AM16/ RLA File :03/95/040/00426/AM16/ Lic.No/Date:0310798872 14.09.2015 Defer Date: 16.11.2016 Decision : The Committee noted that information called for from the firm in NC meeting No.07/82 dated 07.07.2016 is awaited. The Committee decided to await the reply and deferred the case. 137

Case No.:74/14/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01210/AM16/ RLA File :34/24/040/00120/AM16/ Lic.No/Date:3410041510 15.09.2015 Defer Date: 16.11.2016 Decision :Deferred. 138

Case No.:15/14/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01151/AM16/ RLA File :03/95/040/00360/AM16/ Lic.No/Date:0310798909 15.09.2015 Defer Date: 16.11.2016 Decision :Deferred. 139

Case No.:9/14/82-

ALC4/2015 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01145/AM16/ RLA File :03/95/040/00434/AM16/ Lic.No/Date:0310798944 16.09.2015 Defer Date: 16.11.2016 Decision :Deferred. 140

Case No.:124/14/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01260/AM16/ RLA File :09/24/040/00355/AM16/ Lic.No/Date:0910062622 16.09.2015 Defer Date: 16.11.2016 Decision :Deferred. 141

Case No.:35/16/82-

ALC4/2015 Party Name:D. R. COATS INK & RESINS PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred

22 HQ File :01/82/050/01355/AM16/ RLA File :03/94/040/00415/AM16/ Lic.No/Date:0310798977 21.09.2015 Defer Date: 16.11.2016 Decision :Deferred. 142

Case No.:34/16/82-

ALC4/2015 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01354/AM16/ RLA File :03/94/040/00472/AM16/ Lic.No/Date:0310798979 21.09.2015 Defer Date: 16.11.2016 meeting No.03/82 dated 12.05.2016 is awaited. The Committee decided to await the reply and deferred the case. 143

Case No.:64/21/82-

ALC4/2015 Party Name:CADILA HEALTHCARE LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 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: 16.11.2016 144

Case No.:64/14/82-

ALC4/2015 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01200/AM16/ RLA File :09/24/040/00375/AM16/ Lic.No/Date:0910062644 22.09.2015 Defer Date: 16.11.2016 meeting No.20/82 dated 09.03.2016 is awaited. The Committee decided to await the reply and deferred the case. 145

Case No.:117/14/82-

ALC4/2015 Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01253/AM16/ RLA File :04/24/040/00140/AM16/ Lic.No/Date:0410161044 22.09.2015 Defer Date: 16.11.2016 meeting No.07/82 dated 07.07.2016 is awaited. The Committee decided to await the reply and deferred the case. 146

Case No.:103/14/82-

ALC4/2015 Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01239/AM16/ RLA File :09/24/040/00362/AM16/ Lic.No/Date:0910062635 22.09.2015 Defer Date: 16.11.2016 meeting No.03/82 dated 12.05.2016 is awaited. The Committee decided to await the reply and deferred the case. 147

Case No.:25/20/82-

ALC4/2015 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Deferred HQ File :01/82/050/01608/AM16/ RLA File :13/24/040/00027/AM16/ Lic.No/Date:1310047981 23.09.2015 Defer Date: 16.11.2016

23 Decision : The Committee decided to call for copy of DML based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/843/2015-PI(Norms) dated 06.09.2016 , uploaded at the end of these and deferred the case. 148

Case No.:106/14/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01242/AM16/ RLA File :09/24/040/00373/AM16/ Lic.No/Date:0910062649 23.09.2015 Defer Date: 16.11.2016 meeting No.07/82 dated 07.07.2016 is awaited. The Committee decided to await the reply and deferred the case. 149

Case No.:91/14/82-

ALC4/2015 Party Name:CURETECH SKINCARE Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01227/AM16/ RLA File :22/21/040/00029/AM16/ Lic.No/Date:2210015316 24.09.2015 Defer Date: 16.11.2016 meeting No.07/82 dated 07.07.2016 is awaited. The Committee decided to await the reply and deferred the case. 150

Case No.:86/14/82-

ALC4/2015 Party Name:BELLAPREMIER HAPPY HYGIENECARE PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01222/AM16/ RLA File :35/24/040/00005/AM16/ Lic.No/Date:3510044794 25.09.2015 Defer Date: 16.11.2016 meeting No.09/82 dated 10.08.2016 is awaited. The Committee decided to await the reply and deferred the case. 151

Case No.:8/16/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01328/AM16/ RLA File :09/24/040/00294/AM16/ Lic.No/Date:0910062666 28.09.2015 Defer Date: 16.11.2016 Decision :Deferred. 152

Case No.:79/14/82-

ALC4/2015 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01215/AM16/ RLA File :05/23/040/00274/AM16/ Lic.No/Date:0510395773 30.09.2015 Defer Date: 16.11.2016 Decision :Deferred for want of comments from DBT. 153

Case No.:69/16/82-

ALC4/2015 Party Name:PIDILITE INDUSTRIES LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01389/AM16/ RLA File :03/95/040/00350/AM15/ Lic.No/Date:0310799113 30.09.2015 Defer Date: 16.11.2016 Decision :Deferred.

24 154

Case No.:43/16/82-

ALC4/2015 Party Name:INDOFIL INDUSTRIES LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01363/AM16/ RLA File :03/94/040/00423/AM16/ Lic.No/Date:0310799184 05.10.2015 Defer Date: 16.11.2016 Decision :Deferred. 155

Case No.:67/16/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01387/AM16/ RLA File :03/95/040/00485/AM16/ Lic.No/Date:0310799241 06.10.2015 Defer Date: 16.11.2016 Decision :Deferred. 156

Case No.:139/14/82-

ALC4/2015 Party Name:MAMTA POLYCOATS Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01275/AM16/ RLA File :34/24/040/00178/AM16/ Lic.No/Date:3410041581 08.10.2015 Defer Date: 16.11.2016 Decision :Deferred. 157

Case No.:126/16/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01446/AM16/ RLA File :03/95/040/00445/AM16/ Lic.No/Date:0310799287 08.10.2015 Defer Date: 16.11.2016 Decision :Deferred. 158

Case No.:61/16/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01381/AM16/ RLA File :03/95/040/00483/AM16/ Lic.No/Date:0310799284 08.10.2015 Defer Date: 16.11.2016 Decision :Deferred. 159

Case No.:62/16/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01382/AM16/ RLA File :03/95/040/00491/AM16/ Lic.No/Date:0310799292 08.10.2015 Defer Date: 16.11.2016 Decision :Deferred. 160

Case No.:17/16/82-

ALC4/2015 Party Name:VISION DRUGS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01337/AM16/ RLA File :09/24/040/00402/AM16/ Lic.No/Date:0910062693 08.10.2015 Defer Date: 16.11.2016

25 161

Case No.:164/14/82-

ALC4/2015 Party Name:AASHA BIOCHEM Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01300/AM16/ RLA File :10/24/040/00049/AM16/ Lic.No/Date:1010059293 12.10.2015 Defer Date: 16.11.2016 meeting No.05 dated 08.06.2016 is awaited. The Committee decided to await the reply 162

Case No.:140/14/82-

ALC4/2015 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01276/AM16/ RLA File :34/24/040/00175/AM16/ Lic.No/Date:3410041586 12.10.2015 Defer Date: 16.11.2016 Decision :Deferred. 163

Case No.:58/16/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/01378/AM16/ RLA File :03/94/040/00497/AM16/ Lic.No/Date:0310799433 14.10.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/783/2015-PI(Norms) dated 22nd August 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. 164

Case No.:132/14/82-

ALC4/2015 Party Name:RIDDHI PHARMA Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01268/AM16/ RLA File :34/24/040/00180/AM16/ Lic.No/Date:3410041592 14.10.2015 Defer Date: 16.11.2016 Decision :Deferred. 165

Case No.:60/16/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/01380/AM16/ RLA File :03/94/040/00486/AM16/ Lic.No/Date:0310799460 15.10.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/783/2015-PI(Norms) dated 14.07.2016, 166

Case No.:92/16/82-

ALC4/2015 Party Name:TRANSPEK INDUSTRY LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01412/AM16/ RLA File :34/24/040/00185/AM16/ Lic.No/Date:3410041600 15.10.2015 Defer Date: 16.11.2016 Decision :Deferred. 167 Case No.:72/16/82- Party Name:STERLING Meet No/Date:11/82- Status:Deferred

26 ALC4/2015 AUXILIARIES PVT LTD ALC4/2016 07.09.2016 HQ File :01/82/050/01392/AM16/ RLA File :03/95/040/00102/AM16/ Lic.No/Date:0310799579 21.10.2015 Defer Date: 16.11.2016 Decision :Deferred. 168

Case No.:73/16/82-

ALC4/2015 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01393/AM16/ RLA File :03/95/040/00087/AM16/ Lic.No/Date:0310799578 21.10.2015 Defer Date: 16.11.2016 Decision :Deferred. 169

Case No.:29/16/82-

ALC4/2015 & CHEMICALS PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 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: 16.11.2016 Decision :Deferred. 170

Case No.:30/16/82-

ALC4/2015 & CHEMICALS PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01350/AM16/ RLA File :09/24/040/00383/AM16/ Lic.No/Date:0910062767 23.10.2015 Defer Date: 16.11.2016 Decision :Deferred. 171

Case No.:129/16/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01449/AM16/ RLA File :03/95/040/00505/AM16/ Lic.No/Date:0310799628 23.10.2015 Defer Date: 16.11.2016 Decision :Deferred. 172

Case No.:161/14/82-

ALC4/2015 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01297/AM16/ RLA File :03/94/040/01226/AM15/ Lic.No/Date:0310799680 26.10.2015 Defer Date: 16.11.2016 Decision :Deferred. 173

Case No.:78/16/82-

ALC4/2015 Party Name:MOHINI ORGANICS PVT. LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01398/AM16/ RLA File :03/95/040/00777/AM15/ Lic.No/Date:0310799666 26.10.2015 Defer Date: 16.11.2016 Decision :Deferred. 174

Case No.:53/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File RLA File Lic.No/Date:0310799675 Defer Date:

27 :01/82/050/01636/AM16/ :03/95/040/00529/AM16/ 26.10.2015 16.11.2016 Decision :Deferred. 175

Case No.:93/16/82-

ALC4/2015 Party Name:JAINEX SPECIALITY CHEMICAL Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01413/AM16/ RLA File :34/24/040/00196/AM16/ Lic.No/Date:3410041626 28.10.2015 Defer Date: 16.11.2016 Decision :Deferred. 176

Case No.:31/16/82-

ALC4/2015 Party Name:MSN LABORATORIES PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01351/AM16/ RLA File :09/24/040/00423/AM16/ Lic.No/Date:0910062790 28.10.2015 Defer Date: 16.11.2016 Decision :Deferred. 177

Case No.:74/16/82-

ALC4/2015 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01394/AM16/ RLA File :03/95/040/00518/AM16/ Lic.No/Date:0310799705 28.10.2015 Defer Date: 16.11.2016 Decision :Deferred. 178

Case No.:75/16/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01395/AM16/ RLA File :03/95/040/00525/AM16/ Lic.No/Date:0310799704 28.10.2015 Defer Date: 16.11.2016 Decision :Deferred. 179

Case No.:47/16/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01367/AM16/ RLA File :03/95/040/00526/AM16/ Lic.No/Date:0310799853 29.10.2015 Defer Date: 16.11.2016 Decision :Deferred. 180

Case No.:136/14/82-

ALC4/2015 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01272/AM16/ RLA File :05/23/040/00293/AM16/ Lic.No/Date:0510396078 30.10.2015 Defer Date: 16.11.2016 meeting No.03 dated 08.06.2016 is awaited. The Committee decided to await the reply 181

Case No.:159/14/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 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: 16.11.2016

28 meeting No.03 dated 08.06.2016 is awaited. The Committee decided to await the reply 182

Case No.:118/16/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01438/AM16/ RLA File :05/24/040/00345/AM16/ Lic.No/Date:0510396076 30.10.2015 Defer Date: 16.11.2016 meeting No.03 dated 08.06.2016 is awaited. The Committee decided to await the reply 183

Case No.:84/16/82-

ALC4/2015 Party Name:VENUS REMEDIES LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01404/AM16/ RLA File :22/24/040/00055/AM16/ Lic.No/Date:2210015339 30.10.2015 Defer Date: 16.11.2016 meeting No.03 dated 08.06.2016 is awaited. The Committee decided to await the reply 184

Case No.:112/16/82-

ALC4/2015 Party Name:BELCO PHARMA Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01432/AM16/ RLA File :05/23/040/00273/AM16/ Lic.No/Date:0510396205 03.11.2015 Defer Date: 16.11.2016 185

Case No.:107/16/82-

ALC4/2015 Party Name:HELLO PAINTS (P) LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01427/AM16/ RLA File :05/23/040/00326/AM16/ Lic.No/Date:0510396204 03.11.2015 Defer Date: 16.11.2016 Decision :Deferred. 186

Case No.:19/16/82-

ALC4/2015 Party Name:MEDICLONE BIO-TECH PRIVATE LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01339/AM16/ RLA File :04/24/040/00181/AM16/ Lic.No/Date:0410161279 04.11.2015 Defer Date: 16.11.2016 187

Case No.:90/16/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01410/AM16/ RLA File :34/24/040/00207/AM16/ Lic.No/Date:3410041662 05.11.2015 Defer Date: 16.11.2016 Decision :Deferred. 188 Case No.:88/16/82- ALC4/2015 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:11/82- ALC4/2016 Status:Deferred

29 07.09.2016 HQ File :01/82/050/01408/AM16/ RLA File :34/24/040/00202/AM16/ Lic.No/Date:3410041663 05.11.2015 Defer Date: 16.11.2016 Decision :Deferred. 189

Case No.:37/16/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/01357/AM16/ RLA File :03/94/040/00561/AM16/ Lic.No/Date:0310800114 06.11.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/783/2015-PI(Norms) dated 14.07.2016, 190

Case No.:53/16/82-

ALC4/2015 Party Name:LAXMI ORGANIC INDUSTRIES LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01373/AM16/ RLA File :03/95/040/00540/AM16/ Lic.No/Date:0310800090 06.11.2015 Defer Date: 16.11.2016 Decision :Deferred. 191

Case No.:89/16/82-

ALC4/2015 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01409/AM16/ RLA File :34/24/040/00203/AM16/ Lic.No/Date:3410041666 09.11.2015 Defer Date: 16.11.2016 Decision :Deferred. 192

Case No.:2/16/82-

ALC4/2015 Party Name:SANO MEDICAL KITS PVT. LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01322/AM16/ RLA File :04/24/040/00175/AM16/ Lic.No/Date:0410161296 09.11.2015 Defer Date: 16.11.2016 Decision : The Committee noted that information called for from the firm in NC meeting No.18/82 dated 10.02.2016 is awaited. The Committee accordingly deferred the case. 193

Case No.:34/1/82-

ALC1/2016 Party Name:GLAND PHARMA LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01808/AM16/ RLA File :09/24/040/00469/AM16/ Lic.No/Date:0910062848 10.11.2015 Defer Date: 16.11.2016 194

Case No.:114/16/82-

ALC4/2015 Party Name:SHIVA BIOCHEM INDUSTRIES Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01434/AM16/ RLA File :50/24/040/00017/AM16/ Lic.No/Date:5010002240 16.11.2015 Defer Date: 16.11.2016 Decision :Deferred. 195 Case No.:104/16/82- Party Name:JUBILANT Meet No/Date:11/82- Status:Deferred

30 ALC4/2015 LIFE SCIENCES LIMITED ALC4/2016 07.09.2016 HQ File :01/82/050/01424/AM16/ RLA File :05/23/040/00339/AM16/ Lic.No/Date:0510396384 20.11.2015 Defer Date: 16.11.2016 Decision : The Committee noted that information called for from the firm in NC meeting No.18/82 dated 10.02.2016 is awaited. The Committee accordingly deferred the case. 196

Case No.:4/20/82-

ALC4/2015 Party Name:AIMS IMPEX PVT. LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01587/AM16/ RLA File :03/94/040/00656/AM16/ Lic.No/Date:0310800363 23.11.2015 Defer Date: 16.11.2016 Decision :Deferred. 197

Case No.:31/1/82-

ALC1/2016 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01805/AM16/ RLA File :05/24/040/00347/AM16/ Lic.No/Date:0510396399 23.11.2015 Defer Date: 16.11.2016 Decision :Deferred. 198

Case No.:2/20/82-

ALC4/2015 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01585/AM16/ RLA File :05/24/040/00400/AM16/ Lic.No/Date:0510396400 23.11.2015 Defer Date: 16.11.2016 Decision :Deferred. 199

Case No.:33/1/82-

ALC1/2016 Party Name:INCHEM LABORATORIES PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01807/AM16/ RLA File :09/24/040/00486/AM16/ Lic.No/Date:0910062902 26.11.2015 Defer Date: 16.11.2016 Decision :Deferred. 200

Case No.:32/16/82-

ALC4/2015 Party Name:INTERMED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01352/AM16/ RLA File :04/24/040/00177/AM16/ Lic.No/Date:0410161343 26.11.2015 Defer Date: 16.11.2016 Decision : The Committee noted that information called for from the firm in NC meeting No.05/82 dated 08.06.2016 is awaited. The Committee accordingly deferred the case. 201

Case No.:2/1/82-ALC1/2016 Party Name:UNIJULES LIFE

SCIENCES LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 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: 16.11.2016 202 Case No.:23/1/82- ALC1/2016 Party Name:UNILINK PHARMA PVT LTD Meet No/Date:11/82- ALC4/2016 Status:Deferred

31 07.09.2016 HQ File :01/82/050/01797/AM16/ RLA File :04/24/040/00170/AM16/ Lic.No/Date:0410161342 26.11.2015 Defer Date: 16.11.2016 203

Case No.:58/20/82-

ALC4/2015 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01641/AM16/ RLA File :03/95/040/00182/AM15/ Lic.No/Date:0310800550 01.12.2015 Defer Date: 16.11.2016 Decision :Deferred. 204

Case No.:3/1/82-ALC1/2016 Party Name:NEOGEN

CHEMICALS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01777/AM16/ RLA File :03/95/040/00529/AM15/ Lic.No/Date:0310800547 01.12.2015 Defer Date: 16.11.2016 Decision :Deferred. 205

Case No.:5/1/82-ALC1/2016 Party Name:NEOGEN

CHEMICALS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01779/AM16/ RLA File :03/95/040/00239/AM15/ Lic.No/Date:0310800551 01.12.2015 Defer Date: 16.11.2016 Decision :Deferred/ 206

Case No.:33/20/82-

ALC4/2015 Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01616/AM16/ RLA File :03/94/040/00532/AM16/ Lic.No/Date:0310800597 02.12.2015 Defer Date: 16.11.2016 Decision :Deferred. 207

Case No.:54/20/82-

ALC4/2015 Party Name:MELOG SPECIALITY CHEMICALS PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01637/AM16/ RLA File :03/95/040/00631/AM16/ Lic.No/Date:0310800619 03.12.2015 Defer Date: 16.11.2016 Decision :Deferred. 208

Case No.:112/20/82-

ALC4/2015 Party Name:SUPREET CHEMICALS PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01695/AM16/ RLA File :03/95/040/00646/AM16/ Lic.No/Date:0310800620 03.12.2015 Defer Date: 16.11.2016 Decision :Deferred. 209

Case No.:87/20/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01670/AM16/ RLA File :03/95/040/00605/AM16/ Lic.No/Date:0310800715 07.12.2015 Defer Date: 16.11.2016

32 Decision :Deferred. 210

Case No.:127/16/82-

ALC4/2015 Party Name:BLUELINE FOODS (INDIA) PVT.LTD, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01447/AM16/ RLA File :07/24/040/00267/AM16/ Lic.No/Date:0710109146 08.12.2015 Defer Date: 16.11.2016 Decision : : Information called for from the firm in NC meeting No.03/AM17 dated 12.05.2016 is awaited. The committee accordingly deferred the case. 211

Case No.:36/20/82-

ALC4/2015 Party Name:BAYER VAPI PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01619/AM16/ RLA File :03/94/040/00651/AM16/ Lic.No/Date:0310800833 09.12.2015 Defer Date: 16.11.2016 Decision :Deferred. 212

Case No.:67/20/82-

ALC4/2015 Party Name:MANGALAM ORGANICS LIMITED (FORMERLY DUJODWALA Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01650/AM16/ RLA File :03/95/040/00054/AM16/ Lic.No/Date:0310800865 10.12.2015 Defer Date: 16.11.2016 Decision :Deferred. 213

Case No.:110/20/82-

ALC4/2015 Party Name:PROCESS AGROCHEM INDUSTRIES PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01693/AM16/ RLA File :56/24/040/00040/AM16/ Lic.No/Date:5610004767 10.12.2015 Defer Date: 16.11.2016 Decision :Deferred. 214

Case No.:39/20/82-

ALC4/2015 Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01622/AM16/ RLA File :03/94/040/00088/AM16/ Lic.No/Date:0310800889 11.12.2015 Defer Date: 16.11.2016 Decision :Deferred. 215

Case No.:41/20/82-

ALC4/2015 Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01624/AM16/ RLA File :03/94/040/00648/AM16/ Lic.No/Date:0310800905 11.12.2015 Defer Date: 16.11.2016 Decision :Deferred. 216

Case No.:9/1/82-ALC1/2016 Party Name:CAMPHOR &

ALLIED PRODUCTS LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01783/AM16/ RLA File :03/94/040/00490/AM16/ Lic.No/Date:0310800912 11.12.2015 Defer Date: 16.11.2016 Decision :Deferred.

33 217

Case No.:66/20/82-

ALC4/2015 Party Name:PRIVI ORGANICS LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01649/AM16/ RLA File :03/95/040/00633/AM16/ Lic.No/Date:0310800935 11.12.2015 Defer Date: 16.11.2016 Decision :Deferred. 218

Case No.:45/20/82-

ALC4/2015 Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01628/AM16/ RLA File :03/94/040/00736/AM16/ Lic.No/Date:0310800992 14.12.2015 Defer Date: 16.11.2016 Decision :Deferred. 219

Case No.:24/20/82-

ALC4/2015 Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01607/AM16/ RLA File :03/95/040/00088/AM16/ Lic.No/Date:0310800991 14.12.2015 Defer Date: 16.11.2016 Decision :Deferred. 220

Case No.:49/20/82-

ALC4/2015 INDUSTRIES PRIVATE LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01632/AM16/ RLA File :03/94/040/00714/AM16/ Lic.No/Date:0310801093 16.12.2015 Defer Date: 16.11.2016 Decision :Deferred. 221

Case No.:10/1/82-

ALC1/2016 INDUSTRIES PRIVATE LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01784/AM16/ RLA File :03/94/040/00630/AM16/ Lic.No/Date:0310801130 16.12.2015 Defer Date: 16.11.2016 Decision :Deferred. 222

Case No.:46/20/82-

ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01629/AM16/ RLA File :03/94/040/00692/AM16/ Lic.No/Date:0310801111 16.12.2015 Defer Date: 16.11.2016 Decision :Deferred. 223

Case No.:23/20/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01606/AM16/ RLA File :03/95/040/00697/AM16/ Lic.No/Date:0310801116 16.12.2015 Defer Date: 16.11.2016 Decision :Deferred. 224 Case No.:8/20/82- Party Name:SHREE Meet No/Date:11/82- Status:Deferred

34 ALC4/2015 BANKEY BEHARI LAL BOARD MILLS ALC4/2016 07.09.2016 HQ File :01/82/050/01591/AM16/ RLA File :05/24/040/00427/AM16/ Lic.No/Date:0510396637 16.12.2015 Defer Date: 16.11.2016 225

Case No.:8/1/82-ALC1/2016 Party Name:CAMPHOR &

ALLIED PRODUCTS LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01782/AM16/ RLA File :03/94/040/00754/AM16/ Lic.No/Date:0310801214 18.12.2015 Defer Date: 16.11.2016 226

Case No.:83/1/82-

ALC1/2016 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01857/AM16/ RLA File :03/94/040/00752/AM16/ Lic.No/Date:0310801211 18.12.2015 Defer Date: 16.11.2016 Decision : The Committee based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/37/2016-PI(Norms) dated 08.09.2016 decided to call for copy of DML for each of the 18 export products. 227

Case No.:14/20/82-

ALC4/2015 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01597/AM16/ RLA File :03/94/040/00728/AM16/ Lic.No/Date:0310801252 21.12.2015 Defer Date: 16.11.2016 Decision : Information called for from the firm in NC meeting No.05/AM17 dated 08.06.2016 is awaited. The committee accordingly deferred the case. 228

Case No.:19/20/82-

ALC4/2015 Party Name:LAXMI ORGANIC INDUSTRIES LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01602/AM16/ RLA File :03/95/040/00009/AM16/ Lic.No/Date:0310801275 22.12.2015 Defer Date: 16.11.2016 229

Case No.:20/20/82-

ALC4/2015 Party Name:LAXMI ORGANIC INDUSTRIES LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01603/AM16/ RLA File :03/95/040/00267/AM16/ Lic.No/Date:0310801273 22.12.2015 Defer Date: 16.11.2016 230

Case No.:48/20/82-

ALC4/2015 Party Name:ALCHEMIE LABORATORIES Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01631/AM16/ RLA File :03/94/040/00683/AM16/ Lic.No/Date:0310801362 28.12.2015 Defer Date: 16.11.2016 231 Case No.:7/7/82-ALC4/2016 Party Name:CADILA Meet No/Date:11/82- Status:Deferred

35 PHARMACEUTICALS LTD. ALC4/2016 07.09.2016 HQ File :01/82/050/00181/AM17/ RLA File :08/24/040/00333/AM16/ Lic.No/Date:0810136798 29.12.2015 Defer Date: 16.11.2016 232

Case No.:80/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01663/AM16/ RLA File :03/95/040/00736/AM16/ Lic.No/Date:0310801389 29.12.2015 Defer Date: 16.11.2016 233

Case No.:81/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01664/AM16/ RLA File :03/95/040/00735/AM16/ Lic.No/Date:0310801388 29.12.2015 Defer Date: 16.11.2016 234

Case No.:22/20/82-

ALC4/2015 Party Name:S M B CORPORATION OF INDIA Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01605/AM16/ RLA File :03/95/040/00738/AM16/ Lic.No/Date:0310801409 30.12.2015 Defer Date: 16.11.2016 235

Case No.:84/20/82-

ALC4/2015 Party Name:SIRMAXO CHEMICALS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01667/AM16/ RLA File :03/95/040/00730/AM16/ Lic.No/Date:0310801411 30.12.2015 Defer Date: 16.11.2016 Decision : The Committee as per recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/154/2016-PI(Norms) dated 05.09.2016, uploaded at the end of these minutes, decided to call for following information the firm and deferred the case:-

Complete description of export product showing % of content of povidone Iodine and available iodine in the export product.
Unit of export product is showing in numbers. The same be given in kgs and Litres.
Detailed working on the requirement of import input. 236

Case No.:47/20/82-

ALC4/2015 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01630/AM16/ RLA File :03/94/040/00792/AM16/ Lic.No/Date:0310801428 31.12.2015 Defer Date: 16.11.2016 237

Case No.:98/20/82-

ALC4/2015 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File RLA File Lic.No/Date:0510397164 Defer Date:

36 :01/82/050/01681/AM16/ :05/23/040/00338/AM16/ 31.12.2015 16.11.2016 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. 238

Case No.:99/20/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01682/AM16/ RLA File :05/23/040/00389/AM16/ Lic.No/Date:0510397158 31.12.2015 Defer Date: 16.11.2016 239

Case No.:101/20/82-

ALC4/2015 Party Name:SONGWON SPECIALTY CHEMICALS INDIA PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 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: 16.11.2016 240

Case No.:119/20/82-

ALC4/2015 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01702/AM16/ RLA File :09/24/040/00582/AM16/ Lic.No/Date:0910063066 31.12.2015 Defer Date: 16.11.2016 241

Case No.:104/20/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01687/AM16/ RLA File :34/24/040/00253/AM16/ Lic.No/Date:3410041778 04.01.2016 Defer Date: 16.11.2016 242

Case No.:82/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01665/AM16/ RLA File :03/95/040/00750/AM16/ Lic.No/Date:0310801522 04.01.2016 Defer Date: 16.11.2016 243

Case No.:83/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01666/AM16/ RLA File :03/95/040/00749/AM16/ Lic.No/Date:0310801521 04.01.2016 Defer Date: 16.11.2016 244

Case No.:105/20/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01688/AM16/ RLA File :34/24/040/00252/AM16/ Lic.No/Date:3410041782 05.01.2016 Defer Date: 16.11.2016

37 245

Case No.:78/20/82-

ALC4/2015 Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01661/AM16/ RLA File :03/95/040/00652/AM16/ Lic.No/Date:0310801554 05.01.2016 Defer Date: 16.11.2016 246

Case No.:26/20/82-

ALC4/2015 Party Name:AMINES & Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01609/AM16/ RLA File :03/94/040/00802/AM16/ Lic.No/Date:0310801601 06.01.2016 Defer Date: 16.11.2016 247

Case No.:7/1/82-ALC1/2016 Party Name:PRIVI

ORGANICS LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01781/AM16/ RLA File :03/95/040/00688/AM16/ Lic.No/Date:0310801600 06.01.2016 Defer Date: 16.11.2016 248

Case No.:76/20/82-

ALC4/2015 Party Name:AIMS IMPEX PVT. LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01659/AM16/ RLA File :03/94/040/00790/AM16/ Lic.No/Date:0310801644 07.01.2016 Defer Date: 16.11.2016 249

Case No.:103/20/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01686/AM16/ RLA File :05/23/040/00404/AM16/ Lic.No/Date:0510397232 07.01.2016 Defer Date: 16.11.2016 250

Case No.:6/1/82-ALC1/2016 Party Name:MEDISPRAY

LABORATORIES PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01780/AM16/ RLA File :03/95/040/00676/AM16/ Lic.No/Date:0310801634 07.01.2016 Defer Date: 16.11.2016 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/46/2016-PI(Norms) dated 08.09.2016 as per details given below:-

Whether the use of propellant P-227 (Hepta fluoro Propane) in inhalers is approved by MOEF, if so, copy of NOC from MOEF may be furnished. 251

Case No.:32/1/82-

ALC1/2016 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File RLA File Lic.No/Date:0510397230 Defer Date:

38 :01/82/050/01806/AM16/ :05/24/040/00431/AM16/ 07.01.2016 16.11.2016 252

Case No.:95/20/82-

ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01678/AM16/ RLA File :05/24/040/00499/AM16/ Lic.No/Date:0510397256 08.01.2016 Defer Date: 16.11.2016 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. 253

Case No.:79/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01662/AM16/ RLA File :03/95/040/00765/AM16/ Lic.No/Date:0310801655 08.01.2016 Defer Date: 16.11.2016 254

Case No.:21/20/82-

ALC4/2015 Party Name:SHREE LIFE SCIENCES PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01604/AM16/ RLA File :03/95/040/00762/AM16/ Lic.No/Date:0310801691 11.01.2016 Defer Date: 16.11.2016 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. 255

Case No.:19/1/82-ALC1/2016 Party Name:STRIDES

SHASUN LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/01793/AM16/ RLA File :04/24/040/00214/AM16/ Lic.No/Date:0410161494 11.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/33/2016-PI(Norms) dated August 2016, 256

Case No.:60/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01834/AM16/ RLA File :03/94/040/00828/AM16/ Lic.No/Date:0310801732 12.01.2016 Defer Date: 16.11.2016 Decision :Deferred. 257

Case No.:61/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01835/AM16/ RLA File :03/94/040/00820/AM16/ Lic.No/Date:0310801731 12.01.2016 Defer Date: 16.11.2016

39 258

Case No.:48/1/82-

ALC1/2016 Party Name:INDO AMINES LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01822/AM16/ RLA File :03/94/040/00785/AM16/ Lic.No/Date:0310801728 12.01.2016 Defer Date: 16.11.2016 259

Case No.:82/1/82-

ALC1/2016 Party Name:PRIVI ORGANICS LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01856/AM16/ RLA File :03/95/040/00690/AM16/ Lic.No/Date:0310801719 12.01.2016 Defer Date: 16.11.2016 260

Case No.:62/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01836/AM16/ RLA File :03/94/040/00833/AM16/ Lic.No/Date:0310801811 15.01.2016 Defer Date: 16.11.2016 261

Case No.:66/1/82-

ALC1/2016 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01840/AM16/ RLA File :03/94/040/00831/AM16/ Lic.No/Date:0310801850 18.01.2016 Defer Date: 16.11.2016 262

Case No.:64/1/82-ALC1/2016 Party Name:ETERNIS FINE

CHEMICALS LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/01838/AM16/ RLA File :03/94/040/00840/AM16/ Lic.No/Date:0310801857 18.01.2016 Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/ C&PC forwarded vide U.O.No.14010/57/2012-Ch-II dated 21.12.2015, 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. 263

Case No.:79/1/82-

ALC1/2016 Party Name:PRIVI ORGANICS LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01853/AM16/ RLA File :03/95/040/00689/AM16/ Lic.No/Date:0310801831 18.01.2016 Defer Date: 16.11.2016 264

Case No.:80/1/82-ALC1/2016 Party Name:SUNSHIELD

CHEMICALS LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/01854/AM16/ RLA File :03/95/040/00771/AM16/ Lic.No/Date:0310801856 18.01.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the

40 recommendation of D/o C&PC forwarded vide U.O.No.14010/107/2010-Ch-II dated 22.5.2016, 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. 265

Case No.:63/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01837/AM16/ RLA File :03/94/040/00846/AM16/ Lic.No/Date:0310801882 19.01.2016 Defer Date: 16.11.2016 266

Case No.:65/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01839/AM16/ RLA File :03/94/040/00857/AM16/ Lic.No/Date:0310801883 19.01.2016 Defer Date: 16.11.2016 267

Case No.:59/1/82-

ALC1/2016 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01833/AM16/ RLA File :03/94/040/00589/AM16/ Lic.No/Date:0310801896 19.01.2016 Defer Date: 16.11.2016 Decision : Information has been called for from the firm in NC meeting No.05 dated 08.06.2016 is awaited. The Committee accordingly deferred the case. 268

Case No.:114/20/82-

ALC4/2015 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01697/AM16/ RLA File :34/24/040/00263/AM16/ Lic.No/Date:3410041814 19.01.2016 Defer Date: 16.11.2016 269

Case No.:77/1/82-

ALC1/2016 Party Name:MEDISPRAY LABORATORIES PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01851/AM16/ RLA File :03/95/040/00657/AM16/ Lic.No/Date:0310801888 19.01.2016 Defer Date: 16.11.2016 270

Case No.:76/1/82-

ALC1/2016 Party Name:TITAN LABORATORIES PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01850/AM16/ RLA File :03/95/040/00790/AM16/ Lic.No/Date:0310801892 19.01.2016 Defer Date: 16.11.2016 271 Case No.:50/1/82- ALC1/2016 Party Name:AMINES & Meet No/Date:11/82- ALC4/2016 Status:Deferred

41 07.09.2016 HQ File :01/82/050/01824/AM16/ RLA File :03/94/040/00861/AM16/ Lic.No/Date:0310801928 20.01.2016 Defer Date: 16.11.2016 Decision :Deferred. 272

Case No.:68/1/82-

ALC1/2016 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01842/AM16/ RLA File :03/94/040/00834/AM16/ Lic.No/Date:0310801927 20.01.2016 Defer Date: 16.11.2016 273

Case No.:106/20/82-

ALC4/2015 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01689/AM16/ RLA File :05/24/040/00515/AM16/ Lic.No/Date:0510397367 20.01.2016 Defer Date: 16.11.2016 Decision : Information has been called for from the firm in NC meeting No.05 dated 08.06.2016 is awaited. The Committee accordingly deferred the case. 274

Case No.:38/1/82-

ALC1/2016 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01812/AM16/ RLA File :03/95/040/00798/AM16/ Lic.No/Date:0310801923 20.01.2016 Defer Date: 16.11.2016 Decision :Deferred. 275

Case No.:49/1/82-

ALC1/2016 Party Name:AMINES & Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01823/AM16/ RLA File :03/94/040/00869/AM16/ Lic.No/Date:0310801950 21.01.2016 Defer Date: 16.11.2016 Decision :Deferred. 276

Case No.:47/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01821/AM16/ RLA File :03/94/040/00864/AM16/ Lic.No/Date:0310801994 22.01.2016 Defer Date: 16.11.2016 277

Case No.:67/1/82-

ALC1/2016 Party Name:INDOCO REMEDIES LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01841/AM16/ RLA File :03/94/040/00880/AM16/ Lic.No/Date:0310802014 22.01.2016 Defer Date: 16.11.2016 278

Case No.:24/1/82-

ALC1/2016 Party Name:MALLADI DRUGS & PHARMACEUTICALS Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred

42 LIMITED HQ File :01/82/050/01798/AM16/ RLA File :04/24/040/00210/AM16/ Lic.No/Date:0410161548 22.01.2016 Defer Date: 16.11.2016 Decision : Information has been called for from the firm in NC meeting No.07 dated 07.07.2016 is awaited. The Committee accordingly deferred the case. 279

Case No.:72/7/82-

ALC4/2016 Party Name:OGENE SYSTEMS INDIA LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00246/AM17/ RLA File :09/24/040/00620/AM16/ Lic.No/Date:0910063151 22.01.2016 Defer Date: 16.11.2016 Decision :Deferred. 280

Case No.:97/20/82-

ALC4/2015 Party Name:SHREE BANKEY BEHARI LAL AROMATICS Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01680/AM16/ RLA File :05/24/040/00522/AM16/ Lic.No/Date:0510397405 22.01.2016 Defer Date: 16.11.2016 Decision :Deferred. 281

Case No.:96/20/82-

ALC4/2015 Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01679/AM16/ RLA File :02/24/040/00178/AM16/ Lic.No/Date:0210206458 22.01.2016 Defer Date: 16.11.2016 282

Case No.:51/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01825/AM16/ RLA File :03/94/040/00877/AM16/ Lic.No/Date:0310802029 25.01.2016 Defer Date: 16.11.2016 283

Case No.:52/1/82-

ALC1/2016 Party Name:INDO AMINES LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01826/AM16/ RLA File :03/94/040/00888/AM16/ Lic.No/Date:0310802024 25.01.2016 Defer Date: 16.11.2016 Decision :Deferred. 284

Case No.:89/7/82-

ALC4/2016 Party Name:GLAND PHARMA LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00263/AM17/ RLA File :09/24/040/00623/AM16/ Lic.No/Date:0910063196 29.01.2016 Defer Date: 16.11.2016 285

Case No.:88/7/82-

ALC4/2016 & CHEMICALS PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred

43 HQ File :01/82/050/00262/AM17/ RLA File :09/24/040/00304/AM16/ Lic.No/Date:0910063190 29.01.2016 Defer Date: 16.11.2016 286

Case No.:27/1/82-

ALC1/2016 Party Name:BODAL CHEMICALS LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01801/AM16/ RLA File :08/24/040/00325/AM16/ Lic.No/Date:0810137105 01.02.2016 Defer Date: 16.11.2016 287

Case No.:44/1/82-

ALC1/2016 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01818/AM16/ RLA File :03/94/040/00886/AM16/ Lic.No/Date:0310802172 02.02.2016 Defer Date: 16.11.2016 288

Case No.:40/1/82-

ALC1/2016 Party Name:MAGNOLIA LIMITED. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01814/AM16/ RLA File :03/95/040/01074/AM15/ Lic.No/Date:0310802175 02.02.2016 Defer Date: 16.11.2016 Decision : Deferred . 289

Case No.:3/5/82-ALC4/2016 Party Name:PCL OIL &

SOLVENTS LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00162/AM17/ RLA File :05/24/040/00537/AM16/ Lic.No/Date:0510397479 03.02.2016 Defer Date: 16.11.2016 Decision : Deferred . 290

Case No.:35/1/82-

ALC1/2016 Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01809/AM16/ RLA File :31/82/040/00270/AM16/ Lic.No/Date:3110065907 04.02.2016 Defer Date: 16.11.2016 291

Case No.:37/1/82-

ALC1/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01811/AM16/ RLA File :03/95/040/00639/AM16/ Lic.No/Date:0310802231 04.02.2016 Defer Date: 16.11.2016 Decision :Deferred. 292

Case No.:43/1/82-

ALC1/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01817/AM16/ RLA File :03/94/040/00882/AM16/ Lic.No/Date:0310802261 05.02.2016 Defer Date: 16.11.2016 Decision :Deferred.

44 293

Case No.:58/1/82-

ALC1/2016 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 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: 16.11.2016 Decision :Deferred. 294

Case No.:69/1/82-

ALC1/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01843/AM16/ RLA File :03/94/040/00922/AM16/ Lic.No/Date:0310802291 08.02.2016 Defer Date: 16.11.2016 Decision :Deferred. 295

Case No.:74/1/82-

ALC1/2016 Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:11/82- ALC4/2016 07.09.2016 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: 16.11.2016 Decision :Deferred. 296

Case No.:39/1/82-

ALC1/2016 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01813/AM16/ RLA File :03/95/040/00847/AM16/ Lic.No/Date:0310802292 08.02.2016 Defer Date: 16.11.2016 Decision :Deferred. 297

Case No.:45/1/82-

ALC1/2016 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01819/AM16/ RLA File :03/94/040/00859/AM16/ Lic.No/Date:0310802380 09.02.2016 Defer Date: 16.11.2016 Decision :Deferred. 298

Case No.:114/7/82-

ALC4/2016 Party Name:VENUS REMEDIES LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/00288/AM17/ RLA File :22/24/040/00101/AM16/ Lic.No/Date:2210015410 09.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/149/2016-PI(Norms) dated August 2016, 299

Case No.:70/1/82-ALC1/2016 Party Name:ENCUBE

ETHICALS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Deferred HQ File :01/82/050/01844/AM16/ RLA File :03/94/040/00935/AM16/ Lic.No/Date:0310802452 10.02.2016 Defer Date: 16.11.2016

45 300

Case No.:79/7/82-

ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 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: 16.11.2016 Decision : Information has been called for from the firm in NC meeting No.09 /82dated 10.08.2016 is awaited. The Committee accordingly deferred the case. 301

Case No.:41/1/82-

ALC1/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01815/AM16/ RLA File :03/95/040/00826/AM16/ Lic.No/Date:0310802395 10.02.2016 Defer Date: 16.11.2016 Decision :Deferred. 302

Case No.:78/1/82-

ALC1/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01852/AM16/ RLA File :03/95/040/00752/AM16/ Lic.No/Date:0310802451 10.02.2016 Defer Date: 16.11.2016 Decision :Deferred. 303

Case No.:77/7/82-

ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00251/AM17/ RLA File :09/24/040/00664/AM16/ Lic.No/Date:0910063251 11.02.2016 Defer Date: 16.11.2016 Decision : The Committee based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/237/2016-PI(Norms) dated 08.09.2016 decided to call for following information from the firm:-

% wastage on API applied for the manufacture of 1000mg Tablet.
Detailed calculation for requirement of (Potassium Clavulanate+ Avicel) in active base vis-a-vis the composition given in the DML. 304

Case No.:80/7/82-ALC4/2016 Party Name:AUROBINDO

PHARMA LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/00254/AM17/ RLA File :09/24/040/00646/AM16/ Lic.No/Date:0910063250 11.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/205/2016-PI(Norms) dated 08.09.2016, 305

Case No.:2/7/82-ALC4/2016 Party Name:COVALENT

LABORATORIES PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/00176/AM17/ RLA File :09/24/040/00647/AM16/ Lic.No/Date:0910063256 12.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/202/2016-PI(Norms) dated 22.08.2016,

46 306

Case No.:73/1/82-

ALC1/2016 Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01847/AM16/ RLA File :03/94/040/00953/AM16/ Lic.No/Date:0310802552 12.02.2016 Defer Date: 16.11.2016 Decision : Deferred
307

Case No.:26/1/82-

ALC1/2016 Party Name:UMA ENTERPRISE Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01800/AM16/ RLA File :08/24/040/00396/AM16/ Lic.No/Date:0810137202 15.02.2016 Defer Date: 16.11.2016 Decision :Deferred. 308

Case No.:84/7/82-ALC4/2016 Party Name:AUROBINDO

PHARMA LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/00258/AM17/ RLA File :09/24/040/00663/AM16/ Lic.No/Date:0910063276 16.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/205/2016-PI(Norms) dated 08.09.2016, 309

Case No.:56/1/82-

ALC1/2016 Party Name:ZIM LABORATORIES LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 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: 16.11.2016 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/28/2016–PI(Norms) dated August 2016, uploaded at the end of these minutes and deferred the case. 310

Case No.:17/1/82-

ALC1/2016 Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01791/AM16/ RLA File :04/24/040/00229/AM16/ Lic.No/Date:0410161613 17.02.2016 Defer Date: 16.11.2016 Decision :Deferred. 311

Case No.:57/1/82-

ALC1/2016 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01831/AM16/ RLA File :03/95/040/00895/AM16/ Lic.No/Date:0310802676 17.02.2016 Defer Date: 16.11.2016 Decision :Deferred. 312 Case No.:56/1/83- Party Name:ORCH Meet No/Date:11/82- Status:Deferred

47 ALC1/2016 LABORATORIES INDIA PVT LTD ALC4/2016 07.09.2016 HQ File :01/83/050/00905/AM16/ RLA File :09/24/040/00692/AM16/ Lic.No/Date:0910063297 19.02.2016 Defer Date: 16.11.2016 313

Case No.:87/7/82-

ALC4/2016 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00261/AM17/ RLA File :09/24/040/00696/AM16/ Lic.No/Date:0910063310 22.02.2016 Defer Date: 16.11.2016 Decision :Deferred. 314

Case No.:78/7/82-

ALC4/2016 Party Name:VIVIMED LABS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00252/AM17/ RLA File :09/24/040/00592/AM16/ Lic.No/Date:0910063303 22.02.2016 Defer Date: 16.11.2016 Decision :Deferred. 315

Case No.:116/7/82-

ALC4/2016 Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00290/AM17/ RLA File :22/24/040/00111/AM16/ Lic.No/Date:2210015421 26.02.2016 Defer Date: 16.11.2016 316

Case No.:12/7/82-

ALC4/2016 Party Name:MEDICLONE BIO-TECH PRIVATE LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00186/AM17/ RLA File :04/24/040/00250/AM16/ Lic.No/Date:0410161677 01.03.2016 Defer Date: 16.11.2016 Decision : Deferred for want of comments from DBT.. 317

Case No.:18/1/82-ALC1/2016 Party Name:STRIDES

SHASUN LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/01792/AM16/ RLA File :04/24/040/00248/AM16/ Lic.No/Date:0410161671 01.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/34/2016-PI(Norms) dated 29.08.2016, 318

Case No.:20/1/82-ALC1/2016 Party Name:STRIDES

SHASUN LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/01794/AM16/ RLA File :04/24/040/00247/AM16/ Lic.No/Date:0410161672 01.03.2016 Defer Date: 16.11.2016 Pharmaceuticals forwarded vide O.M. No.35011/35/2016-PI(Norms) dated 29.08.2016,

48 319

Case No.:21/1/82-ALC1/2016 Party Name:STRIDES

SHASUN LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/01795/AM16/ RLA File :04/24/040/00246/AM16/ Lic.No/Date:0410161670 01.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/23/2016-PI(Norms) dated August 2016, 320

Case No.:67/7/82-

ALC4/2016 Party Name:BIOLOGICAL E LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Deferred HQ File :01/82/050/00241/AM17/ RLA File :09/24/040/00714/AM16/ Lic.No/Date:0910063353 03.03.2016 Defer Date:29.11.2016
Decision : The Committee decided to call for following information from the firm:-

CoA of the import item from foreign supplier.
Past production vis-a-vis actual consumption of imported input duly certified by Central Excise Authorities. The Committee accordingly deferred the case. 321

Case No.:82/7/82-

ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00256/AM17/ RLA File :09/24/040/00721/AM16/ Lic.No/Date:0910063357 03.03.2016 Defer Date: 16.11.2016 Decision : Information has been called for from the firm in NC meeting No.09 dated 10.08.2016 is awaited. The Committee accordingly deferred the case. 322

Case No.:119/7/82-

ALC4/2016 Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00293/AM17/ RLA File :22/24/040/00121/AM16/ Lic.No/Date:2210015426 04.03.2016 Defer Date: 16.11.2016 323

Case No.:118/7/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00292/AM17/ RLA File :22/24/040/00114/AM16/ Lic.No/Date:2210015440 09.03.2016 Defer Date: 16.11.2016 324

Case No.:120/7/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00294/AM17/ RLA File :22/24/040/00113/AM16/ Lic.No/Date:2210015441 09.03.2016 Defer Date: 16.11.2016

49 325

Case No.:59/7/82-

ALC4/2016 Party Name:RUCHI SOYA INDUSTRIES LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00233/AM17/ RLA File :56/24/040/00054/AM16/ Lic.No/Date:5610004864 11.03.2016 Defer Date: 16.11.2016 Decision :Deferred. 326

Case No.:24/2/82-

ALC4/2016 Party Name:SCOPE CHEMICALS PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00024/AM17/ RLA File :03/95/040/00955/AM16/ Lic.No/Date:0310803229 11.03.2016 Defer Date: 16.11.2016 Decision :Deferred. 327

Case No.:100/7/82-

ALC4/2016 Party Name:CATAPHARMA CHEMICALS PVT. LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00274/AM17/ RLA File :31/83/040/00174/AM16/ Lic.No/Date:3110066051 14.03.2016 Defer Date: 16.11.2016 Decision :Deferred. 328

Case No.:15/1/82-

ALC1/2016 Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01789/AM16/ RLA File :09/24/040/00713/AM16/ Lic.No/Date:0910063416 15.03.2016 Defer Date: 16.11.2016 329

Case No.:14/1/82-

ALC1/2016 Party Name:DIVIS LABORATORIES LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01788/AM16/ RLA File :09/24/040/00716/AM16/ Lic.No/Date:0910063414 15.03.2016 Defer Date: 16.11.2016 330

Case No.:110/7/82-

ALC4/2016 Party Name:TIDE INDUSTRIES Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00284/AM17/ RLA File :34/24/040/00338/AM16/ Lic.No/Date:3410041981 16.03.2016 Defer Date: 16.11.2016 Decision :Deferred. 331

Case No.:107/7/82-

ALC4/2016 Party Name:ASTRAL STERITECH PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00281/AM17/ RLA File :34/24/040/00345/AM16/ Lic.No/Date:3410041995 21.03.2016 Defer Date: 16.11.2016 Decision :Deferred. 332

Case No.:109/7/82-

ALC4/2016 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred

50 HQ File :01/82/050/00283/AM17/ RLA File :34/24/040/00336/AM16/ Lic.No/Date:3410041989 21.03.2016 Defer Date: 16.11.2016 Decision :Deferred. 333

Case No.:111/7/82-

ALC4/2016 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00285/AM17/ RLA File :34/24/040/00346/AM16/ Lic.No/Date:3410041992 21.03.2016 Defer Date: 16.11.2016 Decision :Deferred. 334

Case No.:122/7/82-

ALC4/2016 INDUSTRIES PRIVATE LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00296/AM17/ RLA File :03/94/040/01019/AM16/ Lic.No/Date:0310803499 22.03.2016 Defer Date: 16.11.2016 Decision :Deferred. 335

Case No.:48/4/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00111/AM17/ RLA File :03/94/040/01067/AM16/ Lic.No/Date:0310803525 23.03.2016 Defer Date: 16.11.2016 Decision :Deferred. 336

Case No.:57/7/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00231/AM17/ RLA File :22/24/040/00125/AM16/ Lic.No/Date:2210015455 23.03.2016 Defer Date: 16.11.2016 337

Case No.:61/7/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00235/AM17/ RLA File :22/24/040/00127/AM16/ Lic.No/Date:2210015457 23.03.2016 Defer Date: 16.11.2016 338

Case No.:62/7/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00236/AM17/ RLA File :22/24/040/00128/AM16/ Lic.No/Date:2210015456 23.03.2016 Defer Date: 16.11.2016 339

Case No.:85/1/82-

ALC1/2016 Party Name:DIVIS LABORATORIES LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/01859/AM16/ RLA File :09/24/040/00730/AM16/ Lic.No/Date:0910063440 23.03.2016 Defer Date: 16.11.2016

51 340

Case No.:3/7/82-ALC4/2016 Party Name:DHANUKA

LABORATORIES LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/00177/AM17/ RLA File :05/23/040/00551/AM16/ Lic.No/Date:0510398033 28.03.2016 Defer Date: Decision The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/206/2016-PI(Norms) dated 08.09.2016, 341

Case No.:60/11/82-

ALC4/2016 Party Name:GRANULES INDIA LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00594/AM17/ RLA File :09/24/040/00759/AM16/ Lic.No/Date:0910063450 29.03.2016 Defer Date: 16.11.2016 342

Case No.:63/11/82-

ALC4/2016 Party Name:GRANULES INDIA LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved
HQ File :01/82/050/00597/AM17/ RLA File :09/24/040/00748/AM16/ Lic.No/Date:0910063449 29.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/270/2016-PI(Norms) dated 21.10.2016, 343

Case No.:5/7/82-ALC4/2016 Party Name:CADILA

PHARMACEUTICALS LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00179/AM17/ RLA File :08/24/040/00466/AM16/ Lic.No/Date:0810137553 30.03.2016 Defer Date: 16.11.2016 344

Case No.:39/7/82-

ALC4/2016 Party Name:POSY PHARMACHEM PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00213/AM17/ RLA File :08/24/040/00426/AM16/ Lic.No/Date:0810137551 30.03.2016 Defer Date: 16.11.2016 345

Case No.:58/7/82-

ALC4/2016 Party Name:VENUS REMEDIES LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00232/AM17/ RLA File :22/24/040/00133/AM16/ Lic.No/Date:2210015463 31.03.2016 Defer Date: 16.11.2016 346

Case No.:138/7/82-

ALC4/2016 Party Name:ALTA LABORATORIES LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred

52 HQ File :01/82/050/00312/AM17/ RLA File :03/94/040/01112/AM16/ Lic.No/Date:0310803707 01.04.2016 Defer Date: 16.11.2016 Decision :Deferred. 347

Case No.:81/11/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00615/AM17/ RLA File :03/94/040/01096/AM16/ Lic.No/Date:0310803709 01.04.2016 Defer Date: 348

Case No.:103/7/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00277/AM17/ RLA File :05/23/040/00555/AM16/ Lic.No/Date:0510398126 01.04.2016 Defer Date: 16.11.2016 Decision :Deferred. 349

Case No.:104/7/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00278/AM17/ RLA File :05/23/040/00556/AM16/ Lic.No/Date:0510398125 01.04.2016 Defer Date: 16.11.2016 Decision :Deferred. 350

Case No.:121/7/82-

ALC4/2016 Party Name:VARUN MEDIMPEX INC. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00295/AM17/ RLA File :05/24/040/00632/AM16/ Lic.No/Date:0510398119 01.04.2016 Defer Date: 16.11.2016 351

Case No.:4/7/82-ALC4/2016 Party Name:CADILA

PHARMACEUTICALS LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00178/AM17/ RLA File :08/24/040/00001/AM17/ Lic.No/Date:0810137612 05.04.2016 Defer Date: 16.11.2016 352

Case No.:6/7/82-ALC4/2016 Party Name:CADILA

PHARMACEUTICALS LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00180/AM17/ RLA File :08/24/040/00470/AM16/ Lic.No/Date:0810137611 05.04.2016 Defer Date: 16.11.2016 353

Case No.:24/7/82-

ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00198/AM17/ RLA File :31/83/040/00186/AM16/ Lic.No/Date:3110066111 05.04.2016 Defer Date: 16.11.2016

53 Decision :Deferred. 354

Case No.:38/7/82-

ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00212/AM17/ RLA File :05/23/040/00571/AM16/ Lic.No/Date:0510398134 05.04.2016 Defer Date: 16.11.2016 Decision :Deferred. 355

Case No.:105/7/82-

ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00279/AM17/ RLA File :05/23/040/00573/AM16/ Lic.No/Date:0510398133 05.04.2016 Defer Date: 16.11.2016 356

Case No.:106/7/82-

ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00280/AM17/ RLA File :05/23/040/00570/AM16/ Lic.No/Date:0510398132 05.04.2016 Defer Date: 16.11.2016 357

Case No.:123/7/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00297/AM17/ RLA File :03/94/040/01038/AM16/ Lic.No/Date:0310803819 06.04.2016 Defer Date: 16.11.2016 358

Case No.:42/7/82-

ALC4/2016 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00216/AM17/ RLA File :34/24/040/00325/AM16/ Lic.No/Date:3410042036 07.04.2016 Defer Date: 16.11.2016 359

Case No.:43/7/82-

ALC4/2016 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00217/AM17/ RLA File :34/24/040/00355/AM16/ Lic.No/Date:3410042037 07.04.2016 Defer Date: 16.11.2016 360

Case No.:150/7/82-

ALC4/2016 Party Name:CLARIANT INDIA LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/00324/AM17/ RLA File :03/94/040/00003/AM17/ Lic.No/Date:0310803875 11.04.2016 Defer Date:
Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.12/82 dated 10.12.2014, 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

54 take necessary action as per decision of NC. 361

Case No.:151/7/82-

ALC4/2016 Party Name:CLARIANT INDIA LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/00325/AM17/ RLA File :03/94/040/00002/AM17/ Lic.No/Date:0310803873 11.04.2016 Defer Date:
Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.04/82 dated 16.05.2013, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 362

Case No.:52/7/82-

ALC4/2016 Party Name:FINE CURE PHARMACEUTICALS LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00226/AM17/ RLA File :08/24/040/00460/AM16/ Lic.No/Date:0810137652 11.04.2016 Defer Date: 16.11.2016 363

Case No.:45/7/82-

ALC4/2016 Party Name:ASTRAL STERITECH PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00219/AM17/ RLA File :34/24/040/00009/AM17/ Lic.No/Date:3410042064 13.04.2016 Defer Date: 16.11.2016 364

Case No.:87/11/82-

ALC4/2016 Party Name:KLJ PLASTICIZERS LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00621/AM17/ RLA File :05/23/040/00554/AM16/ Lic.No/Date:0510398217 13.04.2016 Defer Date: 16.11.2016 Decision :Deferred. 365

Case No.:50/7/82-

ALC4/2016 Party Name:BODAL CHEMICALS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00224/AM17/ RLA File :08/24/040/00005/AM17/ Lic.No/Date:0810137692 18.04.2016 Defer Date: 16.11.2016 Decision :Deferred. 366

Case No.:10/7/82-ALC4/2016 Party Name:STRIDES

SHASUN LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/00184/AM17/ RLA File :04/24/040/00002/AM17/ Lic.No/Date:0410161814 18.04.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/155/2016-PI(Norms) dated 05.09.2016, 367 Case No.:11/7/82-ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:11/82- ALC4/2016 Status: Approved

55 07.09.2016 HQ File :01/82/050/00185/AM17/ RLA File :04/24/040/00003/AM17/ Lic.No/Date:0410161815 18.04.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/155/2016-PI(Norms) dated 05.09.2016, 368

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

SHASUN LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/00187/AM17/ RLA File :04/24/040/00004/AM17/ Lic.No/Date:0410161816 18.04.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/155/2016-PI(Norms) dated 05.09.2016, 369

Case No.:98/7/82-ALC4/2016 Party Name:CADILA

HEALTHCARE LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/00272/AM17/ RLA File :08/24/040/00015/AM17/ Lic.No/Date:0810137712 21.04.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/170/2016-PI(Norms) dated 30.09.2016, 370

Case No.:33/7/82-

ALC4/2016 Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00207/AM17/ RLA File :05/23/040/00018/AM17/ Lic.No/Date:0510398279 22.04.2016 Defer Date: 16.11.2016 Decision: The Committee decided to call for complete technical information as per Appendix-33 based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/206/2016-PI(Norms) dated 08.09.2016, 371

Case No.:29/7/82-ALC4/2016 Party Name:MOREPEN

LABORATORIES LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/00203/AM17/ RLA File :05/24/040/00028/AM17/ Lic.No/Date:0510398295 25.04.2016 Defer Date: Decision : The Committee decided ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/201/2016-PI(Norms) dated August 2016, 372

Case No.:15/7/82-

ALC4/2016 Party Name:SUPREET CHEMICALS PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00189/AM17/ RLA File :52/24/040/00006/AM17/ Lic.No/Date:5210041869 25.04.2016 Defer Date: 16.11.2016

56 373

Case No.:99/7/82-ALC4/2016 Party Name:SUPREET

CHEMICALS PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/00273/AM17/ RLA File :52/24/040/00007/AM17/ Lic.No/Date:5210041868 25.04.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.08/82 dated 11.07.2013, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.
374

Case No.:125/7/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00299/AM17/ RLA File :03/95/040/00061/AM17/ Lic.No/Date:0310804144 25.04.2016 Defer Date: 16.11.2016 Decision :Deferred. 375

Case No.:126/7/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00300/AM17/ RLA File :03/95/040/00064/AM17/ Lic.No/Date:0310804154 25.04.2016 Defer Date: 16.11.2016 Decision :Deferred. 376

Case No.:145/7/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00319/AM17/ RLA File :03/94/040/00072/AM17/ Lic.No/Date:0310804202 26.04.2016 Defer Date: 16.11.2016 377

Case No.:144/7/82-

ALC4/2016 Party Name:GOLD STAR CHEMICALS PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00318/AM17/ RLA File :03/94/040/01042/AM16/ Lic.No/Date:0310804172 26.04.2016 Defer Date: 16.11.2016 Decision :Deferred. 378

Case No.:148/7/82-

ALC4/2016 Party Name:HEMA DYE CHEM PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00322/AM17/ RLA File :03/94/040/00055/AM17/ Lic.No/Date:0310804211 26.04.2016 Defer Date: 16.11.2016 Decision :Deferred. 379

Case No.:127/7/82-

ALC4/2016 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File RLA File Lic.No/Date:0310804183 Defer Date:

57 :01/82/050/00301/AM17/ :03/95/040/00048/AM17/ 26.04.2016 16.11.2016 Decision :Deferred. 380

Case No.:128/7/82-

ALC4/2016 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00302/AM17/ RLA File :03/95/040/00049/AM17/ Lic.No/Date:0310804184 26.04.2016 Defer Date: 16.11.2016 Decision :Deferred. 381

Case No.:32/7/82-

ALC4/2016 Party Name:HELLO PAINTS (P) LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00206/AM17/ RLA File :05/23/040/00036/AM17/ Lic.No/Date:0510398321 27.04.2016 Defer Date: 16.11.2016 382

Case No.:130/7/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00304/AM17/ RLA File :03/95/040/00068/AM17/ Lic.No/Date:0310804238 27.04.2016 Defer Date: 16.11.2016 383

Case No.:146/7/82-

ALC4/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00320/AM17/ RLA File :03/94/040/00012/AM17/ Lic.No/Date:0310804283 29.04.2016 Defer Date: 16.11.2016 384

Case No.:147/7/82-

ALC4/2016 INDUSTRIES PRIVATE LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00321/AM17/ RLA File :03/94/040/00063/AM17/ Lic.No/Date:0310804284 29.04.2016 Defer Date: 16.11.2016 385

Case No.:143/7/82-

ALC4/2016 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00317/AM17/ RLA File :03/94/040/00064/AM17/ Lic.No/Date:0310804295 29.04.2016 Defer Date: 16.11.2016 386

Case No.:142/7/82-

ALC4/2016 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00316/AM17/ RLA File :03/94/040/01101/AM16/ Lic.No/Date:0310804342 02.05.2016 Defer Date: 16.11.2016

58 Decision : The Committee based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/185/2016-PI(Norms) dated 08.09.2016 decided to call for following information from the firm:-

Complete technical details as per appendix-33 showing mol. Weight and % yield on molar basis for each step of manufacturing process.
Past production vis-a-vis actual consumption of imported inputs duly certified by Central Excise Authorities. 387

Case No.:129/7/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00303/AM17/ RLA File :03/95/040/00004/AM17/ Lic.No/Date:0310804339 02.05.2016 Defer Date: 16.11.2016 Decision :Deferred. 388

Case No.:14/7/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00188/AM17/ RLA File :08/24/040/00035/AM17/ Lic.No/Date:0810137832 03.05.2016 Defer Date: 16.11.2016 389

Case No.:75/7/82-

ALC4/2016 Party Name:ALKALOIDS CORPORATION Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00249/AM17/ RLA File :02/24/040/00016/AM17/ Lic.No/Date:0210206661 04.05.2016 Defer Date: 16.11.2016 390

Case No.:21/7/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00195/AM17/ RLA File :08/24/040/00049/AM17/ Lic.No/Date:0810137835 04.05.2016 Defer Date: 16.11.2016 391

Case No.:6/11/82-

ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00540/AM17/ RLA File :09/24/040/00052/AM17/ Lic.No/Date:0910063584 05.05.2016 Defer Date: 16.11.2016 392

Case No.:49/7/82-

ALC4/2016 Party Name:PANACEA BIOTEC LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00223/AM17/ RLA File :05/24/040/00009/AM17/ Lic.No/Date:0510398392 05.05.2016 Defer Date: 16.11.2016 Decision : Deferred for want of comments from DBT. 393 Case No.:8/7/82-ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:11/82- ALC4/2016 Status:Deferred

59 07.09.2016 HQ File :01/82/050/00182/AM17/ RLA File :04/24/040/00009/AM17/ Lic.No/Date:0410161871 05.05.2016 Defer Date: 16.11.2016 Decision : The Committee as per recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/154/2016-PI(Norms) dated 05.09.2016, decided to call for copy of Master Batch Formula duly authenticated by their Q.C. incharge from the firm and deferred the case. 394

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

SHASUN LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00183/AM17/ RLA File :04/24/040/00010/AM17/ Lic.No/Date:0410161872 05.05.2016 Defer Date: 16.11.2016 Decision : The Committee as per recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/154/2016-PI(Norms) dated 05.09.2016, decided to call for copy of Master Batch Formula duly authenticated by their Q.C. incharge from the firm and deferred the case. 395

Case No.:163/7/82-

ALC4/2016 Party Name:AMINES & Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00337/AM17/ RLA File :03/94/040/00090/AM17/ Lic.No/Date:0310804480 09.05.2016 Defer Date: 16.11.2016 Decision :Deferred. 396

Case No.:141/7/82-

ALC4/2016 INDUSTRIES PRIVATE LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00315/AM17/ RLA File :03/94/040/00041/AM17/ Lic.No/Date:0310804465 09.05.2016 Defer Date: 16.11.2016 397

Case No.:17/7/82-

ALC4/2016 Party Name:CONTINENTAL CHEMICALS Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00191/AM17/ RLA File :08/24/040/00045/AM17/ Lic.No/Date:0810137878 09.05.2016 Defer Date: 16.11.2016 398

Case No.:18/7/82-

ALC4/2016 Party Name:CONTINENTAL CHEMICALS Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00192/AM17/ RLA File :08/24/040/00044/AM17/ Lic.No/Date:0810137877 09.05.2016 Defer Date: 16.11.2016 399

Case No.:161/7/82-

ALC4/2016 Party Name:GITANJALI CHEMICALS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00335/AM17/ RLA File :03/94/040/00026/AM17/ Lic.No/Date:0310804504 09.05.2016 Defer Date: 16.11.2016

60 400

Case No.:51/7/82-

ALC4/2016 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00225/AM17/ RLA File :05/23/040/00539/AM16/ Lic.No/Date:0510398432 09.05.2016 Defer Date: 16.11.2016 401

Case No.:159/7/82-

ALC4/2016 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00333/AM17/ RLA File :03/94/040/00061/AM17/ Lic.No/Date:0310804534 10.05.2016 Defer Date: 16.11.2016 402

Case No.:160/7/82-

ALC4/2016 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00334/AM17/ RLA File :03/94/040/00036/AM17/ Lic.No/Date:0310804533 10.05.2016 Defer Date: 16.11.2016 403

Case No.:76/7/82-

ALC4/2016 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00250/AM17/ RLA File :05/23/040/00031/AM17/ Lic.No/Date:0510398443 10.05.2016 Defer Date: 16.11.2016 404

Case No.:137/7/82-

ALC4/2016 Party Name:RELIANCE INDUSTRIES LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00311/AM17/ RLA File :03/95/040/00763/AM16/ Lic.No/Date:0310804513 10.05.2016 Defer Date: 16.11.2016 Decision :Deferred. 405

Case No.:84/11/82-

ALC4/2016 Party Name:NEULAND LABORATORIES LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00618/AM17/ RLA File :09/24/040/00039/AM17/ Lic.No/Date:0910063615 11.05.2016 Defer Date: 16.11.2016 406

Case No.:157/7/82-

ALC4/2016 Party Name:APEX PHARMA, Meet No/Date:11/82- ALC4/2016 07.09.2016 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: 16.11.2016 407 Case No.:74/7/82- ALC4/2016 Party Name:KLJ Meet No/Date:11/82- ALC4/2016 Status:Deferred

61 07.09.2016 HQ File :01/82/050/00248/AM17/ RLA File :05/23/040/00050/AM17/ Lic.No/Date:0510398481 12.05.2016 Defer Date: 16.11.2016 408

Case No.:158/7/82-

ALC4/2016 Party Name:KUBO COMBUSTION EFFICIENCY CHEMICALS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00332/AM17/ RLA File :03/94/040/01064/AM16/ Lic.No/Date:0310804642 12.05.2016 Defer Date: 16.11.2016 409

Case No.:131/7/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00305/AM17/ RLA File :03/95/040/00016/AM17/ Lic.No/Date:0310804666 13.05.2016 Defer Date: 16.11.2016 410

Case No.:86/11/82-

ALC4/2016 Party Name:ALMELO PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Deferred HQ File :01/82/050/00620/AM17/ RLA File :09/24/040/00056/AM17/ Lic.No/Date:0910063626 17.05.2016 Defer Date: 16.11.2016 411

Case No.:85/11/82-

ALC4/2016 Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Deferred. HQ File :01/82/050/00619/AM17/ RLA File :09/24/040/00028/AM17/ Lic.No/Date:0910063644 17.05.2016 Defer Date: 16.11.2016 412

Case No.:82/11/82-

ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred. HQ File :01/82/050/00616/AM17/ RLA File :05/24/040/00624/AM16/ Lic.No/Date:0510398507 17.05.2016 Defer Date: 16.11.2016 413

Case No.:54/7/82-

ALC4/2016 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00228/AM17/ RLA File :05/23/040/00064/AM17/ Lic.No/Date:0510398544 18.05.2016 Defer Date: 16.11.2016 414

Case No.:55/7/82-ALC4/2016 Party Name:FRESENIUS

KABI ONCOLOGY LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File RLA File Lic.No/Date:0510398543 Defer Date:

62 :01/82/050/00229/AM17/ :05/23/040/00063/AM17/ 18.05.2016 Pharmaceuticals forwarded vide O.M. No.35011/161/2016-PI(Norms) dated 5th September 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. 415

Case No.:83/11/82-

ALC4/2016 Party Name:BIOLOGICAL E LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Deferred HQ File :01/82/050/00617/AM17/ RLA File :09/24/040/00307/AM15/ Lic.No/Date:0910063658 19.05.2016 Defer Date: 16.11.2016 Decision : Deferred for want of comments from DBT. 416

Case No.:53/7/82-

ALC4/2016 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00227/AM17/ RLA File :08/24/040/00069/AM17/ Lic.No/Date:0810137950 19.05.2016 Defer Date: 16.11.2016 417

Case No.:2/5/82-ALC4/2016 Party Name:ACEBRIGHT

(INDIA) PHARMA PVT LTD, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Deferred HQ File :01/82/050/00161/AM17/ RLA File :07/24/040/00036/AM17/ Lic.No/Date:0710109851 20.05.2016 Defer Date: 16.11.2016 Decision : Deferred 418

Case No.:1/5/82-ALC4/2016 Party Name:RA CHEM

PHARMA LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00160/AM17/ RLA File :09/24/040/00083/AM17/ Lic.No/Date:0910063660 20.05.2016 Defer Date: 16.11.2016 419

Case No.:132/7/82-

ALC4/2016 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00306/AM17/ RLA File :03/95/040/00118/AM17/ Lic.No/Date:0310804885 20.05.2016 Defer Date: 16.11.2016 Decision :Deferred. 420

Case No.:156/7/82-

ALC4/2016 Party Name:AMINES & Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00330/AM17/ RLA File :03/94/040/00147/AM17/ Lic.No/Date:0310804903 23.05.2016 Defer Date: 16.11.2016 421

Case No.:139/7/82-

ALC4/2016 Party Name:GANGWAL CHEMICALS (P) LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred

63 HQ File :01/82/050/00313/AM17/ RLA File :03/94/040/00149/AM17/ Lic.No/Date:0310804914 23.05.2016 Defer Date: 16.11.2016 Decision :Deferred. 422

Case No.:140/7/82-

ALC4/2016 Party Name:GANGWAL CHEMICALS (P) LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00314/AM17/ RLA File :03/94/040/00148/AM17/ Lic.No/Date:0310804913 23.05.2016 Defer Date: 16.11.2016 Decision :Deferred. 423

Case No.:153/7/82-

ALC4/2016 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00327/AM17/ RLA File :03/94/040/00115/AM17/ Lic.No/Date:0310804948 24.05.2016 Defer Date: 16.11.2016 Decision :Deferred. 424

Case No.:152/7/82-

ALC4/2016 INDUSTRIES PRIVATE LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00326/AM17/ RLA File :03/94/040/00152/AM17/ Lic.No/Date:0310804950 24.05.2016 Defer Date: 16.11.2016 425

Case No.:134/7/82-

ALC4/2016 Party Name:ORBIT LIFE SCIENCE PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00308/AM17/ RLA File :03/95/040/00069/AM17/ Lic.No/Date:0310804944 24.05.2016 Defer Date: 16.11.2016 426

Case No.:88/11/82-

ALC4/2016 Party Name:ESTEEM INDUSTRIES PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00622/AM17/ RLA File :17/24/040/00027/AM17/ Lic.No/Date:1710006342 26.05.2016 Defer Date: 16.11.2016 427

Case No.:3/6/82-ALC4/2016 Party Name:INTAS

PHARMACEUTICALS LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Rejected HQ File :01/82/050/00165/AM17/ RLA File :08/24/040/00086/AM17/ Lic.No/Date:0810138080 02.06.2016 Defer Date:
Decision : The Committee noted that firm vide letter dated 30.07.2016 has informed that the subject authorisation has been issued under para 4.7.1 of HBP and no need to fix the norms. The Committee accordingly decided to close the case. 428

Case No.:4/6/82-ALC4/2016 Party Name:INTAS

PHARMACEUTICALS LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Rejected HQ File RLA File Lic.No/Date:0810138086 Defer Date:

64 :01/82/050/00166/AM17/ :08/24/040/00089/AM17/ 02.06.2016 Decision : The Committee noted that firm vide letter dated30.07.2016 has informed that the subject authorisation has been issued under para 4.7.1 of HBP and no need to fix the norms. The Committee accordingly decided to close the case. 429

Case No.:2/11/82-

ALC4/2016 Party Name:MANALI PETROCHEMICALS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00536/AM17/ RLA File :04/24/040/00270/AM16/ Lic.No/Date:0410162005 02.06.2016 Defer Date: 16.11.2016 430

Case No.:1/11/82-

ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00535/AM17/ RLA File :05/23/040/00110/AM17/ Lic.No/Date:0510398726 03.06.2016 Defer Date: 16.11.2016 431

Case No.:8/11/82-

ALC4/2016 Party Name:SOFTGEL HEALTH CARE PVT. LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00542/AM17/ RLA File :04/24/040/00042/AM17/ Lic.No/Date:0410162009 03.06.2016 Defer Date: 16.11.2016 432

Case No.:61/11/82-

ALC4/2016 Party Name:KEKULE PHARMA LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00595/AM17/ RLA File :09/24/040/00017/AM17/ Lic.No/Date:0910063781 09.06.2016 Defer Date: 16.11.2016 433

Case No.:62/11/82-

ALC4/2016 & CHEMICALS PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00596/AM17/ RLA File :09/24/040/00077/AM17/ Lic.No/Date:0910063788 10.06.2016 Defer Date: 16.11.2016 Decision :Deferred. 434

Case No.:64/11/82-

ALC4/2016 & CHEMICALS PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00598/AM17/ RLA File :09/24/040/00076/AM17/ Lic.No/Date:0910063789 10.06.2016 Defer Date: 16.11.2016 Decision : Deferred 435

Case No.:3/11/82-

ALC4/2016 Party Name:DANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00537/AM17/ RLA File :03/94/040/00151/AM17/ Lic.No/Date:0310805608 20.06.2016 Defer Date: 16.11.2016

65 Decision : Deferred 436

Case No.:1/7/82-ALC4/2016 Party Name:NEULAND

LABORATORIES LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Deferred HQ File :01/82/050/00175/AM17/ RLA File :09/24/040/00139/AM17/ Lic.No/Date:0910063809 21.06.2016 Defer Date: 16.11.2016 437

Case No.:5/11/82-

ALC4/2016 Party Name:ASCENT FINECHEM PVT. LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00539/AM17/ RLA File :08/24/040/00104/AM17/ Lic.No/Date:0810138218 28.06.2016 Defer Date: 16.11.2016 Decision : Deferred 438

Case No.:16/11/82-

ALC4/2016 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00550/AM17/ RLA File :03/95/040/00255/AM17/ Lic.No/Date:0310805798 29.06.2016 Defer Date: 16.11.2016 Decision : Deferred 439

Case No.:44/11/82-

ALC4/2016 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00578/AM17/ RLA File :03/94/040/00243/AM17/ Lic.No/Date:0310805848 30.06.2016 Defer Date: 16.11.2016 440

Case No.:49/11/82-

ALC4/2016 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00583/AM17/ RLA File :03/94/040/00253/AM17/ Lic.No/Date:0310805837 30.06.2016 Defer Date: 16.11.2016 441

Case No.:51/11/82-

ALC4/2016 Party Name:IPCA LABORATORIES LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/00585/AM17/ RLA File :03/94/040/00244/AM17/ Lic.No/Date:0310805835 30.06.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/182/2016- PI(Norms) dated August 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. 442

Case No.:45/11/82-

ALC4/2016 Party Name:KUBO COMBUSTION EFFICIENCY CHEMICALS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred

66 HQ File :01/82/050/00579/AM17/ RLA File :03/94/040/00249/AM17/ Lic.No/Date:0310805832 30.06.2016 Defer Date: 16.11.2016 Decision : Deferred . 443

Case No.:7/11/82-

ALC4/2016 Party Name:PANERA BIOTEC PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00541/AM17/ RLA File :05/24/040/00136/AM17/ Lic.No/Date:0510398951 30.06.2016 Defer Date: 16.11.2016 Decision : Deferred for want of comments from DBT. 444

Case No.:14/11/82-

ALC4/2016 Party Name:PALADIN PAINTS AND CHEMICALS PVT. LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00548/AM17/ RLA File :03/95/040/00277/AM17/ Lic.No/Date:0310805923 04.07.2016 Defer Date: 16.11.2016 445

Case No.:50/11/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00584/AM17/ RLA File :03/94/040/00275/AM17/ Lic.No/Date:0310805959 05.07.2016 Defer Date: 16.11.2016 446

Case No.:53/11/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00587/AM17/ RLA File :03/94/040/00273/AM17/ Lic.No/Date:0310805958 05.07.2016 Defer Date: 16.11.2016 447

Case No.:48/11/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00582/AM17/ RLA File :03/94/040/00255/AM17/ Lic.No/Date:0310805960 05.07.2016 Defer Date: 16.11.2016 448

Case No.:15/11/82-

ALC4/2016 Party Name:N S CHEMICALS Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00549/AM17/ RLA File :03/95/040/00119/AM17/ Lic.No/Date:0310805965 05.07.2016 Defer Date: 16.11.2016 Decision :Deferred. 449

Case No.:12/11/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00546/AM17/ RLA File :03/95/040/00285/AM17/ Lic.No/Date:0310806007 08.07.2016 Defer Date: 16.11.2016

67 Decision :Deferred. 450

Case No.:13/11/82-

ALC4/2016 Party Name:S M CHEMICAL VAPI PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00547/AM17/ RLA File :03/95/040/00225/AM17/ Lic.No/Date:0310806063 11.07.2016 Defer Date: 16.11.2016 Decision :Deferred. 451

Case No.:42/11/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00576/AM17/ RLA File :03/94/040/00198/AM17/ Lic.No/Date:0310806121 12.07.2016 Defer Date: 16.11.2016 452

Case No.:43/11/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00577/AM17/ RLA File :03/94/040/00105/AM17/ Lic.No/Date:0310806120 12.07.2016 Defer Date: 16.11.2016 453

Case No.:39/11/82-

ALC4/2016 Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00573/AM17/ RLA File :03/94/040/00966/AM16/ Lic.No/Date:0310806146 12.07.2016 Defer Date: 16.11.2016 454

Case No.:9/11/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00543/AM17/ RLA File :03/94/040/00277/AM17/ Lic.No/Date:0310806159 12.07.2016 Defer Date: 16.11.2016 455

Case No.:24/11/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00558/AM17/ RLA File :03/94/040/00272/AM17/ Lic.No/Date:0310806154 12.07.2016 Defer Date: 16.11.2016 456

Case No.:46/11/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00580/AM17/ RLA File :03/94/040/00276/AM17/ Lic.No/Date:0310806157 12.07.2016 Defer Date: 16.11.2016 457 Case No.:47/11/82- Party Name:ENCUBE Meet No/Date:11/82- Status:Case

68 ALC4/2016 ETHICALS PVT LTD ALC4/2016 07.09.2016 Deferred HQ File :01/82/050/00581/AM17/ RLA File :03/94/040/00274/AM17/ Lic.No/Date:0310806156 12.07.2016 Defer Date: 16.11.2016 458

Case No.:40/11/82-

ALC4/2016 Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00574/AM17/ RLA File :03/94/040/00237/AM17/ Lic.No/Date:0310806115 12.07.2016 Defer Date: 16.11.2016 Decision :Deferred. 459

Case No.:52/11/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00586/AM17/ RLA File :03/94/040/00288/AM17/ Lic.No/Date:0310806113 12.07.2016 Defer Date: 16.11.2016 460

Case No.:41/11/82-

ALC4/2016 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00575/AM17/ RLA File :03/94/040/01110/AM16/ Lic.No/Date:0310806126 12.07.2016 Defer Date: 16.11.2016 461

Case No.:89/11/82-

ALC4/2016 Party Name:MALWA OXYGEN & INDUSTRIAL GASES PVT.LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00623/AM17/ RLA File :56/24/040/00015/AM17/ Lic.No/Date:5610004949 12.07.2016 Defer Date: 16.11.2016 Decision :Deferred. 462

Case No.:4/11/82-

ALC4/2016 Party Name:ATUL LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00538/AM17/ RLA File :08/24/040/00113/AM17/ Lic.No/Date:0810138282 13.07.2016 Defer Date: 16.11.2016 Decision :Deferred. 463

Case No.:58/11/82-

ALC4/2016 Party Name:U SQUARE LIFESCIENCE PRIVATE LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/00592/AM17/ RLA File :08/24/040/00126/AM17/ Lic.No/Date:0810138278 13.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/151/2016-PI(Norms) dated August 2016,

69 464

Case No.:57/11/82-

ALC4/2016 Party Name:ZIM LABORATORIES LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00591/AM17/ RLA File :03/95/040/00296/AM17/ Lic.No/Date:0310806194 13.07.2016 Defer Date: 16.11.2016 Decision : Deferred for want of comments from DoP.
465

Case No.:68/11/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00602/AM17/ RLA File :08/24/040/00116/AM17/ Lic.No/Date:0810138288 14.07.2016 Defer Date: 16.11.2016 466

Case No.:73/11/82-

ALC4/2016 Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00607/AM17/ RLA File :05/23/040/00192/AM17/ Lic.No/Date:0510399089 14.07.2016 Defer Date: 16.11.2016 467

Case No.:10/11/82-

ALC4/2016 Party Name:MATRIX FINE SCIENCES PVT.LTD., Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00544/AM17/ RLA File :03/95/040/00304/AM17/ Lic.No/Date:0310806238 14.07.2016 Defer Date: 16.11.2016 468

Case No.:56/11/82-

ALC4/2016 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00590/AM17/ RLA File :03/95/040/00746/AM16/ Lic.No/Date:0310806245 14.07.2016 Defer Date: 16.11.2016 Decision :Deferred. 469

Case No.:75/11/82-

ALC4/2016 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/00609/AM17/ RLA File :03/95/040/00614/AM16/ Lic.No/Date:0310806246 14.07.2016 Defer Date: decision taken by NC in its meeting No.06/82 dated 29.08.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. 470

Case No.:54/11/82-

ALC4/2016 Party Name:SWISS PARENTERALS PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00588/AM17/ RLA File :08/24/040/00138/AM17/ Lic.No/Date:0810138287 14.07.2016 Defer Date: 16.11.2016

70 471

Case No.:69/11/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00603/AM17/ RLA File :08/24/040/00146/AM17/ Lic.No/Date:0810138302 15.07.2016 Defer Date: 16.11.2016 472

Case No.:72/11/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00606/AM17/ RLA File :08/24/040/00145/AM17/ Lic.No/Date:0810138301 15.07.2016 Defer Date: 16.11.2016 473

Case No.:38/11/82-

ALC4/2016 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00572/AM17/ RLA File :03/94/040/00224/AM17/ Lic.No/Date:0310806304 15.07.2016 Defer Date: 16.11.2016 474

Case No.:34/11/82-

ALC4/2016 Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00568/AM17/ RLA File :03/94/040/00114/AM17/ Lic.No/Date:0310806356 18.07.2016 Defer Date: 16.11.2016 Decision :Deferred. 475

Case No.:37/11/82-

ALC4/2016 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00571/AM17/ RLA File :03/94/040/00220/AM17/ Lic.No/Date:0310806338 18.07.2016 Defer Date: 16.11.2016 476

Case No.:36/11/82-

ALC4/2016 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00570/AM17/ RLA File :03/94/040/00226/AM17/ Lic.No/Date:0310806366 18.07.2016 Defer Date: 16.11.2016 477

Case No.:23/11/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00557/AM17/ RLA File :03/94/040/00301/AM17/ Lic.No/Date:0310806378 19.07.2016 Defer Date: 16.11.2016 478

Case No.:67/11/82-

ALC4/2016 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred

71 HQ File :01/82/050/00601/AM17/ RLA File :05/23/040/00065/AM17/ Lic.No/Date:0510399129 19.07.2016 Defer Date: 16.11.2016 479

Case No.:66/11/82-

ALC4/2016 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00600/AM17/ RLA File :05/23/040/00147/AM17/ Lic.No/Date:0510399130 19.07.2016 Defer Date: 16.11.2016 Decision :Deferred. 480

Case No.:11/11/82-

ALC4/2016 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/00545/AM17/ RLA File :03/95/040/00608/AM16/ Lic.No/Date:0310806372 19.07.2016 Defer Date: decision taken by NC in its meeting No.33/82 dated 21.03.2013, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. 481

Case No.:17/11/82-

ALC4/2016 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/00551/AM17/ RLA File :03/95/040/00578/AM16/ Lic.No/Date:0310806374 19.07.2016 Defer Date: decision taken by NC in its meeting No.20/82 dated 20.09.2012, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.
482

Case No.:21/11/82-

ALC4/2016 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00555/AM17/ RLA File :03/95/040/00206/AM17/ Lic.No/Date:0310806373 19.07.2016 Defer Date: 16.11.2016 Decision :Deferred. 483

Case No.:28/11/82-

ALC4/2016 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/00562/AM17/ RLA File :03/95/040/00729/AM15/ Lic.No/Date:0310806387 19.07.2016 Defer Date:
decision taken by NC in its meeting No.21/82 dated dated 29.08.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. 484

Case No.:18/11/82-

ALC4/2016 Party Name:RESONANCE SPECIALTIES LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred

72 HQ File :01/82/050/00552/AM17/ RLA File :03/95/040/00262/AM17/ Lic.No/Date:0310806401 19.07.2016 Defer Date: 16.11.2016 Decision :Deferred. 485

Case No.:35/11/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00569/AM17/ RLA File :03/94/040/00283/AM17/ Lic.No/Date:0310806427 20.07.2016 Defer Date: 16.11.2016 Decision :Deferred. 486

Case No.:74/11/82-

ALC4/2016 Party Name:KLJ Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00608/AM17/ RLA File :05/23/040/00195/AM17/ Lic.No/Date:0510399160 20.07.2016 Defer Date: 16.11.2016 Decision :Deferred. 487

Case No.:29/11/82-

ALC4/2016 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/00563/AM17/ RLA File :03/95/040/00584/AM16/ Lic.No/Date:0310806430 21.07.2016 Defer Date: decision taken by NC in its meeting No.20/82 dated 20.09.2012, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. 488

Case No.:19/11/82-

ALC4/2016 Party Name:REANNON PHARMACEUTICALS Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00553/AM17/ RLA File :03/95/040/00326/AM17/ Lic.No/Date:0310806484 21.07.2016 Defer Date: 16.11.2016 489

Case No.:25/11/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00559/AM17/ RLA File :03/95/040/00180/AM17/ Lic.No/Date:0310806477 21.07.2016 Defer Date: 16.11.2016 Decision : Deferred 490

Case No.:26/11/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00560/AM17/ RLA File :03/95/040/00116/AM17/ Lic.No/Date:0310806480 21.07.2016 Defer Date: 16.11.2016 Decision : Deferred 491

Case No.:27/11/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred

73 HQ File :01/82/050/00561/AM17/ RLA File :03/95/040/00143/AM17/ Lic.No/Date:0310806474 21.07.2016 Defer Date: 16.11.2016 Decision : Deferred 492

Case No.:65/11/82-

ALC4/2016 Party Name:DIVIS LABORATORIES LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00599/AM17/ RLA File :09/24/040/00222/AM17/ Lic.No/Date:0910063975 22.07.2016 Defer Date: 16.11.2016 493

Case No.:33/11/82-

ALC4/2016 Party Name:ENALTEC LABS PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00567/AM17/ RLA File :03/94/040/00327/AM17/ Lic.No/Date:0310806514 22.07.2016 Defer Date: 16.11.2016 494

Case No.:20/11/82-

ALC4/2016 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00554/AM17/ RLA File :03/95/040/00498/AM16/ Lic.No/Date:0310806509 22.07.2016 Defer Date: 16.11.2016 Decision :Deferred. 495

Case No.:30/11/82-

ALC4/2016 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:
Approved HQ File :01/82/050/00564/AM17/ RLA File :03/95/040/00703/AM15/ Lic.No/Date:0310806510 22.07.2016 Defer Date: decision taken by NC in its meeting No.33/82 dated 21.03.2013, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.
496

Case No.:31/11/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00565/AM17/ RLA File :03/95/040/00168/AM17/ Lic.No/Date:0310806532 22.07.2016 Defer Date: 16.11.2016 497

Case No.:70/11/82-

ALC4/2016 Party Name:ARCHI EXIM PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00604/AM17/ RLA File :08/24/040/00150/AM17/ Lic.No/Date:0810138353 25.07.2016 Defer Date: 16.11.2016 498

Case No.:71/11/82-

ALC4/2016 Party Name:ARCHI EXIM PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred

74 HQ File :01/82/050/00605/AM17/ RLA File :08/24/040/00151/AM17/ Lic.No/Date:0810138354 25.07.2016 Defer Date: 16.11.2016 499

Case No.:76/11/82-

ALC4/2016 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:11/82- ALC4/2016 07.09.2016 Status: Approved HQ File :01/82/050/00610/AM17/ RLA File :03/95/040/00702/AM15/ Lic.No/Date:0310806549 25.07.2016 Defer Date: decision taken by NC in its meeting No.06/82 dated 29.08.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.
500

Case No.:32/11/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00566/AM17/ RLA File :03/95/040/00290/AM17/ Lic.No/Date:0310806544 25.07.2016 Defer Date: 16.11.2016 501

Case No.:55/11/82-

ALC4/2016 Party Name:SWISS PARENTERALS PVT.LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00589/AM17/ RLA File :08/24/040/00156/AM17/ Lic.No/Date:0810138362 25.07.2016 Defer Date: 16.11.2016 502

Case No.:22/11/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00556/AM17/ RLA File :03/94/040/00262/AM17/ Lic.No/Date:0310806600 26.07.2016 Defer Date: 16.11.2016 503

Case No.:77/11/82-

ALC4/2016 Party Name:ASIATIC DRUGS &PHARMACEUTICALS PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00611/AM17/ RLA File :05/23/040/00124/AM17/ Lic.No/Date:0510399240 27.07.2016 Defer Date: 16.11.2016 504

Case No.:78/11/82-

ALC4/2016 Party Name:ASIATIC DRUGS &PHARMACEUTICALS PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00612/AM17/ RLA File :05/23/040/00123/AM17/ Lic.No/Date:0510399239 27.07.2016 Defer Date: 16.11.2016 505 Case No.:79/11/82- Party Name:ASIATIC Meet No/Date:11/82- Status:Case

75 ALC4/2016 DRUGS &PHARMACEUTICALS PVT. LTD. ALC4/2016 07.09.2016 Deferred HQ File :01/82/050/00613/AM17/ RLA File :05/23/040/00119/AM17/ Lic.No/Date:0510399242 27.07.2016 Defer Date: 16.11.2016 506

Case No.:80/11/82-

ALC4/2016 Party Name:ASIATIC DRUGS &PHARMACEUTICALS PVT. LTD. Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00614/AM17/ RLA File :05/23/040/00125/AM17/ Lic.No/Date:0510399241 27.07.2016 Defer Date: 16.11.2016 507

Case No.:90/11/82-

ALC4/2016 Party Name:MICRO LABS LTD Meet No/Date:11/82- ALC4/2016 07.09.2016 Status:Case Deferred HQ File :01/82/050/00624/AM17/ RLA File :07/24/040/00167/AM17/ Lic.No/Date:0710110277 19.08.2016 Defer Date: 16.11.2016

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