IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2016-05-12

DGFT Committee Minutes

Document text

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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. 03/82/2016 of 2016-17, 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 12.05.2016 under the Chairmanship of Dr. S.K. Bansal, Jt. 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. Shri M.V. Singh, FTDO, DGFT The committee went through the minutes of earlier meeting No. 02/82 held 26.04.2016 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 : 3/82-ALC4/2016 MEETING DATE : 12.05.2016 1

Case No.:173/14/82-

ALC4/2015 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status: deferred HQ File :01/82/050/01309/AM16/ RLA File :03/95/040/00881/AM10/ Lic.No/Date:0310726567 04.03.2013 Defer Date:07.07.2016 Decision : Deferred. 2

Case No.:16/1/82-

ALC1/2016 Party Name:AUCTUS PHARMA LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01790/AM16/ RLA File :09/24/040/00564/AM13/ Lic.No/Date:0910055281 05.03.2013 Defer Date:08.06.2016 Decision : The Committee decided to defer the case for want of comments of DoP. 3

Case No.:113/14/82-

ALC4/2013 Party Name:PARAMOUNT AROMACHEM PVT.LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Deferred HQ File :01/82/050/00698/AM14/ RLA File :05/24/040/00488/AM13/ Lic.No/Date:0510350269 26.03.2013 Defer Date: 14.06.2016

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Case No.:62/2/83-

ALC1/2014 Party Name:STERICON PHARMA PVT.LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status: Approved HQ File :01/83/050/00019/AM15/ RLA File :07/24/040/00279/AM14/ Lic.No/Date:0710099790 20.11.2013 Defer Date: Decision : The Committee decided to ratify norms for the export product on net to net basis without wastage under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. At the time of closure, net content in export may be calculated by the RA. 5

Case No.:29/1/82-

ALC1/2016 Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:
Approved HQ File :01/82/050/01803/AM16/ RLA File :07/24/040/00397/AM14/ Lic.No/Date:0710103004 19.03.2014 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceutical forwarded vide O.M.No.35011/434/2015-PI(Norms) dated 13.10.2015 uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per decision of NC. 6

Case No.:52/6/82-

ALC4/2014 Party Name:UPL LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 7

Case No.:88/6/82-

ALC4/2014 Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 8

Case No.:61/4/82-

ALC4/2014 Party Name:V & V PHARMA INDUSTRIES Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 9

Case No.:69/4/82-

ALC4/2014 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/00317/AM15/ RLA File :09/24/040/00175/AM15/ Lic.No/Date:0910060550 27.06.2014 Defer Date:08.06.2016 10

Case No.:73/9/82-

ALC4/2014 Party Name:D. R. COATS INK & RESINS PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 11 Case No.:79/9/82- Party Meet No/Date:3/82- Status:Deferred

3 ALC4/2014 Name:METROPOLITAN EXIMCHEM LTD. ALC4/2016 12.05.2016 HQ File :01/82/050/00876/AM15/ RLA File :03/95/040/00337/AM15/ Lic.No/Date:0310787073 18.07.2014 Defer Date:08.06.2016 12

Case No.:396/5/82-

ALC4/2015 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 13

Case No.:63/8/82-

ALC4/2014 Party Name:ADCOCK INGRAM LTD, Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 14

Case No.:32/9/82-

ALC4/2014 Party Name:CHEMCON SPECIALITY CHEMICALS P LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 15

Case No.:8/6/82-

ALC4/2014 Party Name:V & V PHARMA INDUSTRIES Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 16

Case No.:58/9/82-

ALC4/2014 Party Name:G AMPHRAY LABORATORIES, Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/00855/AM15/ RLA File :03/94/040/00171/AM15/ Lic.No/Date:0310787536 01.08.2014 Defer Date:08.06.2016 17

Case No.:49/9/82-

ALC4/2014 Party Name:SANMAR SPECIALITY CHEMICALS LIMITED, Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/00846/AM15/ RLA File :04/24/040/00106/AM15/ Lic.No/Date:0410159125 01.08.2014 Defer Date:08.06.2016 Decision :Deferred. 18

Case No.:31/9/82-

ALC4/2014 Party Name:AMBERNATH ORGANICS PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred.

4 19

Case No.:2/14/82-

ALC4/2015 Party Name:SHREE SHIVSHANKAR DRUGS & PHARMACEUTICALS P. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred 20

Case No.:48/5/82-

ALC4/2015 Party Name:VISION DRUGS PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : It was observed that the quantities of import applied by the applicant appear to be disproportionately high. It is a necessary requirement that correct quantities be declared in the application. Whatever quantity has been applied for in the application, the firm should be in a position to justify. Accordingly, firm is to submit its version on immediate basis. 21

Case No.:215/13/82-

ALC4/2014 Party Name:GOLD STAR CHEMICALS PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 22

Case No.:377/5/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 23

Case No.:224/13/82-

ALC4/2014 Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 24

Case No.:225/13/82-

ALC4/2014 Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 25

Case No.:262/13/82-

ALC4/2014 Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 26 Case No.:223/13/82- Party Name:KRISHNA Meet No/Date:3/82- Status:Deferred

5 ALC4/2014 ANTIOXIDANTS PVT. LTD. ALC4/2016 12.05.2016 HQ File :01/82/050/01226/AM15/ RLA File :03/94/040/00508/AM15/ Lic.No/Date:0310788647 02.09.2014 Defer Date:08.06.2016 27

Case No.:3/7/82-

ALC4/2014 Party Name:S V CHEM INTERMEDIATES P LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 28

Case No.:400/5/82-

ALC4/2015 Party Name:YASH RASAYAN & CHEMICALS Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/00540/AM16/ RLA File :34/24/040/00120/AM15/ Lic.No/Date:3410040554 15.09.2014 Defer Date:08.06.2016 Decision :Deferred. 29

Case No.:12/15/82-

ALC4/2014 Party Name:JINDAL DRUGS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 30

Case No.:15/13/82-

ALC4/2014 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 31

Case No.:19/1/82-

ALC4/2015 Party Name:GEM AROMATICS PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 32

Case No.:372/5/82-

ALC4/2015 Party Name:DR J PHARMACHEM (INDIA)(PROP.ADITYA PRAMOD JOGDEO) Meet No/Date:3/82- ALC4/2016 12.05.2016 Status: Deferred HQ File :01/82/050/00512/AM16/ RLA File :31/83/040/00154/AM15/ Lic.No/Date:3110064948 08.10.2014 Defer Date: 07.07.2016 33

Case No.:29/13/82-

ALC4/2014 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016

6 34

Case No.:124/13/82-

ALC4/2014 Party Name:PANACEA BIOTEC LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :The Committee based on the recommendation of DBT forwarded vide letter No.BT/IL/05/316/2010 dated 29.2.2016, uploaded at the end of these minutes decided to call for information from the firm and deferred the case. 35

Case No.:198/5/82-

ALC4/2015 Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 36

Case No.:126/8/82-

ALC4/2015 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 37

Case No.:43/18/82-

ALC4/2014 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 38

Case No.:362/5/82-

ALC4/2015 Party Name:KLJ PLASTICIZERS LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/00502/AM16/ RLA File :05/23/040/00377/AM15/ Lic.No/Date:0510392211 28.11.2014 Defer Date:08.06.2016 Decision :Deferred. 39

Case No.:145/5/82-

ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 40

Case No.:127/5/82-

ALC4/2015 Party Name:EMAMI LIMITED, Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 41

Case No.:133/5/82-

ALC4/2015 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status: Deferred

7 HQ File :01/82/050/00273/AM16/ RLA File :03/94/040/00883/AM15/ Lic.No/Date:0310792178 19.12.2014 Defer Date:08.06.2016 Decision : Deferred for want of comment from DoP. 42

Case No.:136/5/82-

ALC4/2015 Party Name:AVIGNON EXIM PVT.LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/00276/AM16/ RLA File :03/94/040/00843/AM15/ Lic.No/Date:0310792314 23.12.2014 Defer Date:08.06.2016 Decision :Deferred. 43

Case No.:221/5/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 44

Case No.:114/5/82-

ALC4/2015 Party Name:NATIONAL TUBE INDUSTRIES, Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 45

Case No.:218/5/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 46

Case No.:99/18/82-

ALC4/2014 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 47

Case No.:111/18/82-

ALC4/2014 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 48

Case No.:28/7/82-

ALC4/2015 Party Name:PARAMOUNT AROMACHEM PVT.LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status: Deferred HQ File :01/82/050/00633/AM16/ RLA File :05/24/040/00428/AM15/ Lic.No/Date:0510392678 05.01.2015 Defer Date: 08.06.2016 49 Case No.:45/5/82- ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:3/82- ALC4/2016 Status:Deferred

8 12.05.2016 HQ File :01/82/050/00185/AM16/ RLA File :09/24/040/00558/AM15/ Lic.No/Date:0910061483 05.01.2015 Defer Date:08.06.2016 Decision :The committee decided to defer the case for want of comments from DoP. 50

Case No.:102/5/82-

ALC4/2015 Party Name:ALTA LABORATORIES LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : The committee decided to defer the case for want of comments from DoP. 51

Case No.:74/5/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 52

Case No.:149/5/82-

ALC4/2015 Party Name:ALCHEMIE LABORATORIES Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : The committee decided to defer the case for want of comments from DoP. 53

Case No.:121/5/82-

ALC4/2015 Party Name:UNIJULES LIFE SCIENCES LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/00261/AM16/ RLA File :03/95/040/00835/AM15/ Lic.No/Date:0310792685 08.01.2015 Defer Date:08.06.2016 Decision : The committee decided to defer the case for want of comments from DoP. 54

Case No.:219/5/82-

ALC4/2015 Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/00359/AM16/ RLA File :09/24/040/00549/AM15/ Lic.No/Date:0910061517 09.01.2015 Defer Date:08.06.2016 Decision :Deferred. 55

Case No.:239/5/82-

ALC4/2015 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/00379/AM16/ RLA File :09/24/040/00555/AM15/ Lic.No/Date:0910061520 09.01.2015 Defer Date:08.06.2016 Decision : It was observed that the quantities of import mentioned by the applicant are disproportionately high and appear to be totally unjustified. An applicant is expected to submit correct quantities of import. Accordingly, firm is to submit its version/within 15 days to DGFT. 56

Case No.:141/5/82-

ALC4/2015 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/00281/AM16/ RLA File :03/94/040/00746/AM15/ Lic.No/Date:0310792870 13.01.2015 Defer Date:08.06.2016

9 Decision :The Committee decided to send a copy of application to DoP and deferred the case. 57

Case No.:119/5/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/00259/AM16/ RLA File :03/95/040/00843/AM15/ Lic.No/Date:0310792869 13.01.2015 Defer Date:08.06.2016 Decision : The committee decided to defer the case for want of comments from DoP. 58

Case No.:243/5/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/00383/AM16/ RLA File :09/24/040/00589/AM15/ Lic.No/Date:0910061530 14.01.2015 Defer Date:08.06.2016 Decision : The committee decided to defer the case for want of comments from DoP. 59

Case No.:88/5/82-

ALC4/2015 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : The committee decided to defer the case for want of comments from AYUSH. 60

Case No.:138/8/82-

ALC4/2015 Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : The committee decided to defer the case for want of comments from DoP. 61

Case No.:275/5/82-

ALC4/2015 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 62

Case No.:284/5/82-

ALC4/2015 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/00424/AM16/ RLA File :03/94/040/01053/AM15/ Lic.No/Date:0310793620 05.02.2015 Defer Date:08.06.2016 Decision : The committee decided to defer the case for want of comments from DoP. 63

Case No.:285/5/82-

ALC4/2015 Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/00425/AM16/ RLA File :03/94/040/01092/AM15/ Lic.No/Date:0310793985 19.02.2015 Defer Date: Decision :Deferred. 64

Case No.:279/5/82-

ALC4/2015 Party Name:CROWN CHEMICALS PVT.LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred

10 HQ File :01/82/050/00419/AM16/ RLA File :03/94/040/01088/AM15/ Lic.No/Date:0310793983 19.02.2015 Defer Date:08.06.2016 Decision :Deferred. 65

Case No.:288/5/82-

ALC4/2015 Party Name:CROWN CHEMICALS PVT.LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 66

Case No.:335/5/82-

ALC4/2015 Party Name:PRIVI ORGANICS LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 67

Case No.:334/5/82-

ALC4/2015 Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 68

Case No.:309/5/82-

ALC4/2015 Party Name:SHREE VALLABH CHEMICAL Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 69

Case No.:273/5/82-

ALC4/2015 Party Name:BHARAT SERUMS & VACCINES LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :The Committee based on the recommendation of DBT letter No.BT/IL/05/417/2015-PID dated 22.7.2015, uploaded at the end of these minutes decided to call for information from the firm and deferred the case. 70

Case No.:452/5/82-

ALC4/2015 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 71

Case No.:295/5/82-

ALC4/2015 Party Name:PROLIFE INDUSTRIES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred.

11 72

Case No.:303/5/82-

ALC4/2015 Party Name:ASSOCIATED DYESTUFF PVT. LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 73

Case No.:300/5/82-

ALC4/2015 Party Name:ADVANCE PETROCHEMICALS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 74

Case No.:447/5/82-

ALC4/2015 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 75

Case No.:45/4/82-

ALC4/2015 Party Name:TIDE INDUSTRIES Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 76

Case No.:291/5/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 77

Case No.:183/5/82-

ALC4/2015 Party Name:SPAK ORGOCHEM (INDIA) PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/00323/AM16/ RLA File :03/95/040/00964/AM15/ Lic.No/Date:0310794811 23.03.2015 Defer Date:08.06.2016 78

Case No.:29/5/82-

ALC4/2015 Party Name:ASSOCIATED DYESTUFF PVT. LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 79

Case No.:16/5/82-

ALC4/2015 Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/00156/AM16/ RLA File :09/24/040/00736/AM15/ Lic.No/Date:0910061856 31.03.2015 Defer Date:08.06.2016

12 80

Case No.:28/5/82-

ALC4/2015 Party Name:RUCHI SOYA INDUSTRIES LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 Status: approved HQ File :01/82/050/00168/AM16/ RLA File :56/24/040/00064/AM15/ Lic.No/Date:5610004573 31.03.2015 Defer Date: Decision :Approved in NC 02/AM17 dated 26.4.2016. 81

Case No.:26/5/82-

ALC4/2015 Party Name:CONTINENTAL CHEMICALS Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 82

Case No.:411/5/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/00551/AM16/ RLA File :03/95/040/01033/AM15/ Lic.No/Date:0310795186 08.04.2015 Defer Date:08.06.2016 Decision :Information received and sent to DoP on 17.5.2016 and deferred the case. 83

Case No.:81/4/82-

ALC4/2015 Party Name:SATYADEVA PHARMACEUTICALS /P/ LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status: Approved. HQ File :01/82/050/00120/AM16/ RLA File :09/24/040/00728/AM15/ Lic.No/Date:0910061883 15.04.2015 Defer Date:
Decision : Already approved in Meeting No. 20/AM16 dated 09.03.2016 at Sl.No.119. 84

Case No.:5/5/82-

ALC4/2015 Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/00145/AM16/ RLA File :08/24/040/00003/AM16/ Lic.No/Date:0810135051 17.04.2015 Defer Date:08.06.2016 85

Case No.:35/5/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 86

Case No.:132/7/82-

ALC4/2015 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 87

Case No.:153/7/82-

ALC4/2015 Party Name:DR. ACHARYA LABORATORIES PVT. LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File RLA File Lic.No/Date:0310795534 Defer

13 :01/82/050/00758/AM16/ :03/94/040/00039/AM16/ 24.04.2015 Date:08.06.2016 88

Case No.:29/7/82-

ALC4/2015 Party Name:NUTRA SPECIALITIES PVT. LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/00634/AM16/ RLA File :04/24/040/00003/AM16/ Lic.No/Date:0410160438 24.04.2015 Defer Date:08.06.2016 Decision :Deferred. 89

Case No.:40/8/82-

ALC4/2015 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 90

Case No.:174/5/82-

ALC4/2015 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 91

Case No.:176/5/82-

ALC4/2015 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 92

Case No.:177/5/82-

ALC4/2015 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 93

Case No.:111/7/82-

ALC4/2015 Party Name:ZIM LABORATORIES LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/00716/AM16/ RLA File :03/95/040/00058/AM16/ Lic.No/Date:0310795699 05.05.2015 Defer Date:08.06.2016 Decision :Information has already been called in NC Meeting No.02 dated 26.04.2016 94

Case No.:75/8/82-

ALC4/2015 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : Information has already been called in NC Meeting No.02 dated 26.04.2016 95

Case No.:65/8/82-

ALC4/2015 Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status: Deferred

14 HQ File :01/82/050/00861/AM16/ RLA File :09/24/040/00052/AM16/ Lic.No/Date:0910061973 06.05.2015 Defer Date: 08.06.2016 Decision : Department of Pharmaceuticals have furnished their recommendation vide O.M. no. 35011/671/2015-PI (norms) dated 03.05.2016 has also pointed out to ensure the availability of valid drug manufacturing licence (DML) for commercial production. Keeping this in view, the committee decided to call for copy valid Drug Manufacturing license from the firm. 96

Case No.:7/5/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : The import items stated as Meropenem and sodium carbonate (Sterile Bulk). The export is Meropenem Injection. Therefore, it is necessary to understand the composition of the sterile bulk so as to ascertain the content of Meropenem in the same. Wastage shall be finalised accordingly. Firm may clarify whether the export item also contains sodium carbonate.

97

Case No.:38/8/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/00834/AM16/ RLA File :09/24/040/00060/AM16/ Lic.No/Date:0910061998 08.05.2015 Defer Date:08.06.2016 98

Case No.:200/5/82-

ALC4/2015 Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/00340/AM16/ RLA File :04/24/040/00038/AM16/ Lic.No/Date:0410160569 21.05.2015 Defer Date:08.06.2016 99

Case No.:97/8/82-

ALC4/2015 Party Name:ASCENT FINECHEM PVT. LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 100

Case No.:45/8/82-

ALC4/2015 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 101

Case No.:86/8/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/00882/AM16/ RLA File :09/24/040/00131/AM16/ Lic.No/Date:0910062091 29.05.2015 Defer Date:08.06.2016 Decision :Deferred. 102

Case No.:187/7/82-

ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred

15 HQ File :01/82/050/00792/AM16/ RLA File :08/24/040/00057/AM16/ Lic.No/Date:0810135435 05.06.2015 Defer Date:08.06.2016 Decision :Deferred. 103

Case No.:121/8/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 104

Case No.:128/16/82-

ALC4/2015 Party Name:FLAGSHIP BIOTECH INTERNATIONAL PVT. LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status: Approved
HQ File :01/82/050/01448/AM16/ RLA File :03/94/040/00217/AM16/ Lic.No/Date:0310796903 26.06.2015 Defer Date: Decision :The Committee decided to ratify norms as per SION A-412 or as applied by the firm whichever is less under Para 4.07 of HBP.Vol1. RA may call DML before issue. 105

Case No.:89/7/82-

ALC4/2015 Party Name:HALDIA PETROCHEMICALS LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 106

Case No.:5/6/82-

ALC4/2015 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/00601/AM16/ RLA File :34/24/040/00091/AM16/ Lic.No/Date:3410041336 01.07.2015 Defer Date:08.06.2016 Decision :Deferred. 107

Case No.:97/14/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 108

Case No.:109/14/82-

ALC4/2015 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : The Committee decided to defer the case for want of comments of DoP 109

Case No.:7/18/82-

ALC4/2015 Party Name:SHODHANA LABORATORIES LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01472/AM16/ RLA File :09/24/040/00198/AM16/ Lic.No/Date:0910062275 02.07.2015 Defer Date:08.06.2016

16 110

Case No.:28/1/82-

ALC1/2016 Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approve
HQ File :01/82/050/01802/AM16/ RLA File :07/24/040/00092/AM16/ Lic.No/Date:0710108460 03.07.2015 Defer Date: Pharmaceutical forwarded vide O.M.No.35011/434/2015-PI(Norms) dated 13.10.2015 uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per decision of NC. 111

Case No.:104/14/82-

ALC4/2015 Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status: Approved HQ File :01/82/050/01240/AM16/ RLA File :09/24/040/00701/AM15/ Lic.No/Date:0910062324 09.07.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/745/2015-PI(Norms) dated April 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. The Committee also decided to consider above recommendation for revision of SION A-2027. 112

Case No.:54/8/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/00850/AM16/ RLA File :05/23/040/00150/AM16/ Lic.No/Date:0510394862 09.07.2015 Defer Date:08.06.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals forwarded vide O.M.No.35011/662/2015-PI(Norms) dated 21.03.2016, uploaded at the end of these minutes decided to call for information from the firm and deferred the case. 113

Case No.:50/8/82-

ALC4/2015 Party Name:PUSILIN BIOTECHNOLOGY PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred for want of comments of DBT. 114

Case No.:51/14/82-

ALC4/2015 Party Name:SRIAM LABS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01187/AM16/ RLA File :09/24/040/00197/AM16/ Lic.No/Date:0910062326 13.07.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/745/2015-PI(Norms) dated April 2016, uploaded 115

Case No.:54/14/82-

ALC4/2015 Party Name:BIOLOGICAL E LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : Deferred 116 Case No.:59/14/82- Party Name:BIOLOGICAL Meet No/Date:3/82- Status:Deferred

17 ALC4/2015 E LTD ALC4/2016 12.05.2016 HQ File :01/82/050/01195/AM16/ RLA File :09/24/040/00525/AM15/ Lic.No/Date:0910062331 15.07.2015 Defer Date:08.06.2016 Decision : Deferred 117

Case No.:41/14/82-

ALC4/2015 Party Name:DEEPAK NITRITE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 118

Case No.:49/8/82-

ALC4/2015 Party Name:M.L.A. INDUSTRIES Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 119

Case No.:120/8/82-

ALC4/2015 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 120

Case No.:49/14/82-

ALC4/2015 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 121

Case No.:39/14/82-

ALC4/2015 Party Name:JAGSONPAL PHARMACEUTICALS LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 122

Case No.:42/14/82-

ALC4/2015 Party Name:MEDICAMEN ORGANICS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01178/AM16/ RLA File :05/24/040/00193/AM16/ Lic.No/Date:0510395021 21.07.2015 Defer Date: Decision: The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/771/2015-PI(Norms) dated 11.04.2016, 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. It was observed that against content of 84.86kg + 7.996kg, i.e. 92.85kg in export, the firm has applied for import of 199.64kg. Such wastage is impossible. Firm should make a submission within 15 days to NC-III in DGFT as to why it should not be presumed that they have tried to misuse the scheme. 123 Case No.:112/14/82- Party Name:SUVEN LIFE Meet No/Date:3/82- Status:Approved

18 ALC4/2015 SCIENCES LIMITED ALC4/2016 12.05.2016 HQ File :01/82/050/01248/AM16/ RLA File :09/24/040/00221/AM16/ Lic.No/Date:0910062348 21.07.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/750/2015-PI(Norms) dated 04.05.2016, uploaded 124

Case No.:21/16/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred for want of comments from DoP. 125

Case No.:22/16/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01342/AM16/ RLA File :09/24/040/00224/AM16/ Lic.No/Date:0910062360 22.07.2015 Defer Date:08.06.2016 Decision : Deferred for want of comments from DoP. 126

Case No.:50/14/82-

ALC4/2015 Party Name:SRIAM LABS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01186/AM16/ RLA File :09/24/040/00226/AM16/ Lic.No/Date:0910062363 23.07.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/757/2015-PI(Norms) dated 02.05.2016, uploaded 127

Case No.:149/14/82-

ALC4/2015 Party Name:VISION DRUGS PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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: 12.05.2016 Decision : The Committee decided call for information as per Appendix 33 and past production consumption data vis-a-vis actual consumption of imported inputs duly certified by Central Excise Authorities. It was also observed that the quantities of import mentioned by the applicant appear to be disproportionately high. Accordingly, firm is to submit its version on immediate basis. 128

Case No.:79/8/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/00875/AM16/ RLA File :05/24/040/00110/AM16/ Lic.No/Date:0510395084 24.07.2015 Defer Date:08.06.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals forwarded vide O.M.No.35011/781/2015-PI(Norms) dated 26.04.2016, uploaded at the end of these minutes decided to call for information from the firm and deferred the case. 129

Case No.:1/10/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred

19 LIMITED HQ File :01/82/050/00957/AM16/ RLA File :09/24/040/00211/AM16/ Lic.No/Date:0910062393 28.07.2015 Defer Date:08.06.2016 Decision :Deferred. 130

Case No.:170/14/82-

ALC4/2015 Party Name:PI INDUSTRIES LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01306/AM16/ RLA File :13/24/040/00015/AM16/ Lic.No/Date:1310047932 29.07.2015 Defer Date:08.06.2016 Decision :Deferred. 131

Case No.:131/14/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01267/AM16/ RLA File :09/24/040/00212/AM16/ Lic.No/Date:0910062413 30.07.2015 Defer Date:08.06.2016 Decision :Deferred. 132

Case No.:60/14/82-

ALC4/2015 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : Committee decided to defer the case for want of comments of DOP. 133

Case No.:84/1/82-

ALC1/2016 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : Committee decided to defer the case for want of comments of DOP. 134

Case No.:169/14/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 135

Case No.:17/8/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 136

Case No.:168/14/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred.

20 137

Case No.:13/18/82-

ALC4/2015 Party Name:FINE ORGANIC INDUSTRIES PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved
HQ File :01/82/050/01478/AM16/ RLA File :03/94/040/00334/AM16/ Lic.No/Date:0310797973 05.08.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/129/2011-Ch-II dated 4.3.2016 , 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. 138

Case No.:14/14/82-

ALC4/2015 Party Name:ZIM LABORATORIES LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01150/AM16/ RLA File :03/95/040/00356/AM16/ Lic.No/Date:0310798008 07.08.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of
D/o Pharmaceutical forwarded vide O.M.No.35011/766/2015-PI(Norms) dated 26.04.2016, uploaded 139

Case No.:18/14/82-

ALC4/2015 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 140

Case No.:115/16/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01435/AM16/ RLA File :03/95/040/00164/AM16/ Lic.No/Date:0310798051 10.08.2015 Defer Date:08.06.2016 141

Case No.:23/8/82-

ALC4/2015 Party Name:ALPHAMED FORMULATIONS P LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : The Committee based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/690/2015-PI(Norms) dated 21.03.2016 , uploaded at the end of these minutes decided to call for information from the firm and deferred the case. 142

Case No.:155/14/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : The Committee based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/781/2015-PI(Norms) dated 26.04.2016 , uploaded at the end of these minutes 143

Case No.:160/14/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status: Approved

21 HQ File :01/82/050/01296/AM16/ RLA File :09/24/040/00286/AM16/ Lic.No/Date:0910062483 12.08.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/750/2015-PI(Norms) dated 03.05.2016 , of HBP Vol.1. RA concerned may take necessary action as per decision of NC. The quantity of palladium (ii) Catalyst applied for was .52kg/kg, and allowed is .152kg/kg. Firm will explain to NC-III in DGFT as to why the quantity applied for was so high. 144

Case No.:11/18/82-

ALC4/2015 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 145

Case No.:133/14/82-

ALC4/2015 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01269/AM16/ RLA File :09/24/040/00298/AM16/ Lic.No/Date:0910062500 14.08.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/780/2015-PI(Norms) dated 11.04.2016 , of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 146

Case No.:34/14/82-

ALC4/2015 Party Name:TRANSPEK INDUSTRY LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 147

Case No.:96/14/82-

ALC4/2015 Party Name:MAITHRI LABORATORIES (P) LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status: approved HQ File :01/82/050/01232/AM16/ RLA File :09/24/040/00293/AM16/ Lic.No/Date:0910062511 18.08.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/743/2013-PI(Norms) dated April.2016 , uploaded 148

Case No.:99/14/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 149

Case No.:56/13/82-

ALC4/2015 Party Name:PANACEA BIOTEC LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : The Committee based on the recommendation of DBT forwarded vide letter

22 No.BT/IL/05/316/2010 dated 29.2.2016, uploaded at the end of these minutes decided to call for information from the firm and deferred the case. 150

Case No.:154/14/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 151

Case No.:68/14/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 152

Case No.:30/14/82-

ALC4/2015 Party Name:BHARAT PARENTERALS LTD, Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01166/AM16/ RLA File :34/24/040/00143/AM16/ Lic.No/Date:3410041467 20.08.2015 Defer Date:08.06.2016 153

Case No.:6/14/82-

ALC4/2015 Party Name:PREGNA INTERNATIONAL LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status: Approved HQ File :01/82/050/01142/AM16/ RLA File :03/95/040/00364/AM16/ Lic.No/Date:0310798287 20.08.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O.No.46011/22/2008-PC-II dated 5.4.2016, 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. 154

Case No.:66/14/82-

ALC4/2015 Party Name:SRIAM LABS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01202/AM16/ RLA File :09/24/040/00290/AM16/ Lic.No/Date:0910062526 21.08.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/57/2015-PI(Norms) dated 02.05.2016 , uploaded 155

Case No.:23/14/82-

ALC4/2015 Party Name:RUSAN PHARMA LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01159/AM16/ RLA File :03/95/040/00400/AM16/ Lic.No/Date:0310798441 25.08.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/744/2015-PI(Norms) dated 03.05.2016, uploaded 156 Case No.:3/14/82- Party Name:SHIRDI Meet No/Date:3/82- Status:Deferred

23 ALC4/2015 CHEMICALS PVT. LTD. ALC4/2016 12.05.2016 HQ File :01/82/050/01139/AM16/ RLA File :03/95/040/00401/AM16/ Lic.No/Date:0310798433 25.08.2015 Defer Date:
Decision :Deferred. 157

Case No.:54/13/82-

ALC4/2015 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred HQ File :01/82/050/01017/AM16/ RLA File :03/94/040/00089/AM16/ Lic.No/Date:0310798493 26.08.2015 Defer Date:08.06.2016 Decision : Deferred for want of comment from DoP. 158

Case No.:24/14/82-

ALC4/2015 Party Name:SHUBHAM SPECIALTY PRODUCTS Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 159

Case No.:35/14/82-

ALC4/2015 Party Name:VENUS REMEDIES LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01171/AM16/ RLA File :22/24/040/00032/AM16/ Lic.No/Date:2210015295 27.08.2015 Defer Date:08.06.2016 160

Case No.:82/14/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 161

Case No.:89/14/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 162

Case No.:94/14/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 163

Case No.:116/16/82-

ALC4/2015 Party Name:PANERA BIOTEC PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : Deferred for want of comments from DBT.

24 164

Case No.:93/14/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :The Committee decided to defer the case for want of comment of DoP. 165

Case No.:5/18/82-

ALC4/2015 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01470/AM16/ RLA File :52/24/040/00039/AM16/ Lic.No/Date:5210041625 04.09.2015 Defer Date:08.06.2016 Decision :Deferred. 166

Case No.:141/14/82-

ALC4/2015 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:3/82- ALC4/2016 12.05.2016 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:07.04.2016 Decision :Deferred. 167

Case No.:125/16/82-

ALC4/2015 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status: Approved HQ File :01/82/050/01445/AM16/ RLA File :03/94/040/00171/AM16/ Lic.No/Date:0310798674 04.09.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/819/2016-PI(Norms) dated 05.05.2016 , of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 168

Case No.:52/14/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : : The Committee based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/742/2015-PI(Norms) dated 29.4.2016 , uploaded at the end of these minutes 169

Case No.:10/20/82-

ALC4/2015 Party Name:U SQUARE LIFESCIENCE PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01593/AM16/ RLA File :08/24/040/00153/AM16/ Lic.No/Date:0810135975 04.09.2015 Defer Date:08.06.2016 170

Case No.:119/16/82-

ALC4/2015 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01439/AM16/ RLA File :03/94/040/00402/AM16/ Lic.No/Date:0310798725 08.09.2015 Defer Date:08.06.2016

25 171

Case No.:56/14/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 172

Case No.:124/16/82-

ALC4/2015 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01444/AM16/ RLA File :03/94/040/00399/AM16/ Lic.No/Date:0310798771 09.09.2015 Defer Date:08.06.2016 Decision :Deferred. 173

Case No.:46/14/82-

ALC4/2015 Party Name:MALWA OXYGEN & INDUSTRIAL GASES PVT.LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred 174

Case No.:53/14/82-

ALC4/2015 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : It was observed that the quantities of import mentioned by the applicant are disproportionately high and appears to be totally unjustified. An applicant is expected to submit correct quantities of import and if artificially inflated quantities are applied for, it tantamount to a misdeclaration. For example, the quantity of first item of import applied for by the unit is 12.36 kg per kg of export in the application and the quantity recommended by the technical authority is 3.5kg/kg of export. Such wide variation is a cause of concern as it raises the possibility of misdeclaration on the part of the applicant. Accordingly, firm is to submit its version urgently to the NC-3. It was observed that the quantity of inputs such as solvent has been applied much more than may be required. In appendix 11-A, all the item are shown as raw material. Past data is not furnished. Recoverable, is shown as nil in the application. Applications are required to be filed with due case and the applicant would need to reply to the above observation.

175

Case No.:157/14/82-

ALC4/2015 Party Name:AETHER INDUSTRIES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 176

Case No.:122/16/82-

ALC4/2015 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status: Approved HQ File :01/82/050/01442/AM16/ RLA File :03/94/040/00462/AM16/ Lic.No/Date:0310798808 10.09.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/819/2015-PI(Norms) dated 05.05.2016, uploaded

26 177

Case No.:78/14/82-

ALC4/2015 Party Name:AMI LIFESCIENCES P LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01214/AM16/ RLA File :34/24/040/00148/AM16/ Lic.No/Date:3410041505 11.09.2015 Defer Date:08.06.2016 178

Case No.:4/16/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01324/AM16/ RLA File :09/24/040/00297/AM16/ Lic.No/Date:0910062594 11.09.2015 Defer Date:08.06.2016 179

Case No.:9/16/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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: 08.06.2016 180

Case No.:56/16/82-

ALC4/2015 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 181

Case No.:59/16/82-

ALC4/2015 Party Name:INDOCO REMEDIES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01379/AM16/ RLA File :03/94/040/00474/AM16/ Lic.No/Date:0310798877 14.09.2015 Defer Date:08.06.2016 Decision :Deferred. 182

Case No.:8/14/82-

ALC4/2015 Party Name:PRIVI ORGANICS LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 183

Case No.:110/14/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01246/AM16/ RLA File :09/24/040/00305/AM16/ Lic.No/Date:0910062601 14.09.2015 Defer Date:08.06.2016 Decision :Deferred. 184

Case No.:134/14/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred

27 HQ File :01/82/050/01270/AM16/ RLA File :09/24/040/00273/AM16/ Lic.No/Date:0910062602 14.09.2015 Defer Date:08.06.2016 Decision :Deferred. 185

Case No.:7/14/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 186

Case No.:74/14/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 187

Case No.:15/14/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 188

Case No.:9/14/82-

ALC4/2015 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 189

Case No.:98/14/82-

ALC4/2015 Party Name:SRINI PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01234/AM16/ RLA File :09/24/040/00333/AM16/ Lic.No/Date:0910062625 16.09.2015 Defer Date:08.06.2016 Decision :Deferred. 190

Case No.:124/14/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 191

Case No.:35/16/82-

ALC4/2015 Party Name:D. R. COATS INK & RESINS PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01355/AM16/ RLA File :03/94/040/00415/AM16/ Lic.No/Date:0310798977 21.09.2015 Defer Date:08.06.2016 Decision :Deferred. 192 Case No.:34/16/82- ALC4/2015 Party Name:KOPRAN RESEARCH Meet No/Date:3/82- ALC4/2016 Status:Deferred

28 LABORATORIES LTD. 12.05.2016 HQ File :01/82/050/01354/AM16/ RLA File :03/94/040/00472/AM16/ Lic.No/Date:0310798979 21.09.2015 Defer Date:08.06.2016 Decision : The Committee based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/756/2015-PI(Norms) dated 05.05..2016 , uploaded at the end of these minutes 193

Case No.:71/14/82-

ALC4/2015 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01207/AM16/ RLA File :09/24/040/00376/AM16/ Lic.No/Date:0910062633 21.09.2015 Defer Date:08.06.2016 Decision :. It was observed that the quantities of import mentioned by the applicant are disproportionately high and appears to be totally unjustified. An applicant is expected to submit correct quantities of import. Accordingly, firm is to submit its version within 15 days to NC-III in DGFT. 194

Case No.:64/21/82-

ALC4/2015 Party Name:CADILA HEALTHCARE LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 195

Case No.:64/14/82-

ALC4/2015 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : The Committee based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/749/2015-PI(Norms) dated 03.05..2016 , uploaded at the end of these minutes 196

Case No.:117/14/82-

ALC4/2015 Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 197

Case No.:118/14/82-

ALC4/2015 Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01254/AM16/ RLA File :04/24/040/00139/AM16/ Lic.No/Date:0410161045 22.09.2015 Defer Date:08.06.2016 198

Case No.:103/14/82-

ALC4/2015 Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : Department of Pharmaceuticals have furnished their recommendation vide O.M. no. 35011/671/2015-PI (norms) dated 03.05.2016 uploaded at the end of these minutes. DoP has also pointed out to ensure the availability of valid drug manufacturing licence (DML) for commercial production. Keeping this in view, the committee decided to call for copy valid Drug

29 Manufacturing license from the firm. The recommendation of Deptt. Of Pharmaceutical allows the item No.1 as .9983gm per unit; whereas content may be 1gm per unit, and applied quantity is 1.097gm per unit. During discussions it was understood that the quantity is worked out on the basis of the documentation submitted by the applicant. Applicant may inform NC-III whether .9983gm per unit will suffice. 199

Case No.:25/20/82-

ALC4/2015 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 200

Case No.:106/14/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : The Committee based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/750/2015-PI(Norms) dated 03.05.2016 , uploaded at the end of these minutes 201

Case No.:91/14/82-

ALC4/2015 Party Name:CURETECH SKINCARE Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 202

Case No.:5/20/82-

ALC4/2015 Party Name:DORF- KETAL CHEMICALS INDIA PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01588/AM16/ RLA File :03/94/040/00471/AM16/ Lic.No/Date:0310799047 24.09.2015 Defer Date:08.06.2016 Decision :Deferred. 203

Case No.:86/14/82-

ALC4/2015 Party Name:BELLAPREMIER HAPPY HYGIENECARE PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 204

Case No.:65/14/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status :Approved
HQ File :01/82/050/01201/AM16/ RLA File :09/24/040/00291/AM16/ Lic.No/Date:0910062665 28.09.2015 Defer Date: Decision : The import item “Methanol” has been applied for by the applicant, whereas the technical authority has informed that the said item is not required in the process. This is a serious issue as it indicates that an attempt may have been made to import an item which was not actually required. Accordingly, firm is to submit its version/within 15 days to NC-III in DGFT. Meanwhile, the Committee based on the recommendation of D/o Pharmaceutical forwarded vide O.M.No.35011/758/2015-PI(Norms) dated 20.04.2016 decided ratify norms under Para 4.07 of HBP or as applied by the firm whichever is less.

30 205

Case No.:8/16/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 206

Case No.:68/16/82-

ALC4/2015 Party Name:ZIM LABORATORIES LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01388/AM16/ RLA File :03/95/040/00454/AM16/ Lic.No/Date:0310799077 28.09.2015 Defer Date:08.06.2016 207

Case No.:79/14/82-

ALC4/2015 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : Deferred for want of comments from AYUSH. 208

Case No.:6/10/82-

ALC4/2015 Party Name:ARCHIMEDIS LABORATORIES PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/00962/AM16/ RLA File :09/24/040/00321/AM16/ Lic.No/Date:0910062670 30.09.2015 Defer Date:08.06.2016 209

Case No.:69/16/82-

ALC4/2015 Party Name:PIDILITE INDUSTRIES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 210

Case No.:33/16/82-

ALC4/2015 Party Name:BLISS INDASI LIFESCIENCES PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01353/AM16/ RLA File :03/94/040/00483/AM16/ Lic.No/Date:0310799128 01.10.2015 Defer Date:08.06.2016 211

Case No.:55/16/82-

ALC4/2015 Party Name:DORF- KETAL CHEMICALS INDIA PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01375/AM16/ RLA File :03/94/040/00525/AM16/ Lic.No/Date:0310799188 05.10.2015 Defer Date:08.06.2016 Decision :Deferred. 212

Case No.:43/16/82-

ALC4/2015 Party Name:INDOFIL INDUSTRIES LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016

31 Decision :Deferred. 213

Case No.:10/16/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01330/AM16/ RLA File :09/24/040/00266/AM16/ Lic.No/Date:0910062673 05.10.2015 Defer Date:08.06.2016 214

Case No.:67/16/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 215

Case No.:6/16/82-

ALC4/2015 Party Name:HETERO DRUGS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status: Approved HQ File :01/82/050/01326/AM16/ RLA File :09/24/040/00404/AM16/ Lic.No/Date:0910062686 07.10.2015 Defer Date: Decision: The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/823/2015-PI (Norms) dated April 2015, uploaded 216

Case No.:45/16/82-

ALC4/2015 Party Name:INDOCO REMEDIES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 StatusApproved
HQ File :01/82/050/01365/AM16/ RLA File :03/94/040/00529/AM16/ Lic.No/Date:0310799266 07.10.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/775/2015-PI(Norms) dated 02.05.2016, uploaded 217

Case No.:25/16/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01345/AM16/ RLA File :09/24/040/00347/AM16/ Lic.No/Date:0910062681 07.10.2015 Defer Date:08.06.2016 218

Case No.:139/14/82-

ALC4/2015 Party Name:MAMTA POLYCOATS Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 219

Case No.:126/16/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016

32 Decision :Deferred. 220

Case No.:61/16/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 221

Case No.:62/16/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 222

Case No.:17/16/82-

ALC4/2015 Party Name:VISION DRUGS PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : It was observed that the quantities of import mentioned by the applicant appear to be disproportionately high. Accordingly, firm is to submit its version to NC-III in DGFT on immediate basis. 223

Case No.:23/16/82-

ALC4/2015 Party Name:SHREEGEN PHARMA LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01343/AM16/ RLA File :09/24/040/00359/AM16/ Lic.No/Date:0910062695 09.10.2015 Defer Date:08.06.2016 224

Case No.:164/14/82-

ALC4/2015 Party Name:AASHA BIOCHEM Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : The Committee decided to call for DML for export product and deferred the case. 225

Case No.:38/16/82-

ALC4/2015 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01358/AM16/ RLA File :03/94/040/00536/AM16/ Lic.No/Date:0310799342 12.10.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/819/2015-PI(Norms) dated 5.5.2016, 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. 226

Case No.:140/14/82-

ALC4/2015 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred.

33 227

Case No.:144/14/82-

ALC4/2015 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01280/AM16/ RLA File :52/24/040/00049/AM16/ Lic.No/Date:5210041658 14.10.2015 Defer Date:08.06.2016 Decision :Deferred. 228

Case No.:58/16/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01378/AM16/ RLA File :03/94/040/00497/AM16/ Lic.No/Date:0310799433 14.10.2015 Defer Date:08.06.2016 229

Case No.:132/14/82-

ALC4/2015 Party Name:RIDDHI PHARMA Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 230

Case No.:60/16/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01380/AM16/ RLA File :03/94/040/00486/AM16/ Lic.No/Date:0310799460 15.10.2015 Defer Date:08.06.2016 231

Case No.:92/16/82-

ALC4/2015 Party Name:TRANSPEK INDUSTRY LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 232

Case No.:158/14/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01294/AM16/ RLA File :05/23/040/00305/AM16/ Lic.No/Date:0510395945 16.10.2015 Defer Date:08.06.2016 233

Case No.:26/16/82-

ALC4/2015 Party Name:NEULAND LABORATORIES LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01346/AM16/ RLA File :09/24/040/00370/AM16/ Lic.No/Date:0910062746 20.10.2015 Defer Date:08.06.2016 234

Case No.:11/16/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01331/AM16/ RLA File :09/24/040/00425/AM16/ Lic.No/Date:0910062758 20.10.2015 Defer Date:08.06.2016

34 235

Case No.:156/14/82-

ALC4/2015 Party Name:SOFTGEL HEALTH CARE PVT. LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01292/AM16/ RLA File :04/24/040/00158/AM16/ Lic.No/Date:0410161133 20.10.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/782/2015-PI(Norms) dated 11.04.2016, uploaded 236

Case No.:27/16/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01347/AM16/ RLA File :09/24/040/00420/AM16/ Lic.No/Date:0910062753 20.10.2015 Defer Date:08.06.2016 237

Case No.:72/16/82-

ALC4/2015 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01392/AM16/ RLA File :03/95/040/00102/AM16/ Lic.No/Date:0310799579 21.10.2015 Defer Date:08.06.2016 Decision :Deferred. 238

Case No.:73/16/82-

ALC4/2015 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:07.04.2016 Decision :Deferred. 239

Case No.:29/16/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 240

Case No.:30/16/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 241

Case No.:129/16/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred.

35 242

Case No.:161/14/82-

ALC4/2015 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 243

Case No.:78/16/82-

ALC4/2015 Party Name:MOHINI ORGANICS PVT. LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 244

Case No.:53/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01636/AM16/ RLA File :03/95/040/00529/AM16/ Lic.No/Date:0310799675 26.10.2015 Defer Date:08.06.2016 Decision :Deferred. 245

Case No.:93/16/82-

ALC4/2015 Party Name:JAINEX SPECIALITY CHEMICAL Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 246

Case No.:31/16/82-

ALC4/2015 Party Name:MSN LABORATORIES PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 247

Case No.:74/16/82-

ALC4/2015 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 248

Case No.:75/16/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 249

Case No.:9/20/82-

ALC4/2015 Party Name:U SQUARE LIFESCIENCE PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01592/AM16/ RLA File :08/24/040/00237/AM16/ Lic.No/Date:0810136380 28.10.2015 Defer Date:08.06.2016

36 250

Case No.:47/16/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 251

Case No.:136/14/82-

ALC4/2015 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : The Committee based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/764/2015-PI(Norms) dated 5.5.2016, uploaded at the end of these minutes 252

Case No.:48/16/82-

ALC4/2015 Party Name:O C SPECIALITIES PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01368/AM16/ RLA File :03/95/040/00549/AM16/ Lic.No/Date:0310799873 30.10.2015 Defer Date:08.06.2016 Decision :Deferred. 253

Case No.:87/16/82-

ALC4/2015 Party Name:SCOTT-EDIL PHARMACIA LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01407/AM16/ RLA File :22/24/040/00020/AM16/ Lic.No/Date:2210015341 30.10.2015 Defer Date:08.06.2016 254

Case No.:159/14/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals forwarded vide O.M.No.35011/781/2015-PI(Norms) dated 26.04.2016, uploaded at the end of these minutes decided to call for information from the firm and deferred the case. 255

Case No.:118/16/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals forwarded vide O.M.No.35011/781/2015-PI(Norms) dated 26.04.2016, uploaded at the end of these minutes decided to call for information from the firm and deferred the case. 256

Case No.:84/16/82-

ALC4/2015 Party Name:VENUS REMEDIES LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016

37 Decision : The item of export is stated as Cefepine for injection and the item of import Cefepine Hcl/L-Arginine strile USP. Against export of 129.6kg, import of 250kg has been sought. The wastage applied for is very high and it is doubtful that any method of manufacturing can require such huge wastage. If this is so, it is a matter of concern that the firm should attempt to make import to which it is not entitled. Accordingly, firm may clarify the same within 15 days. 257

Case No.:67/21/82-

ALC4/2015 Party Name:CADILA HEALTHCARE LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01772/AM16/ RLA File :08/24/040/00258/AM16/ Lic.No/Date:0810136406 02.11.2015 Defer Date:08.06.2016 258

Case No.:112/16/82-

ALC4/2015 Party Name:BELCO PHARMA Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 259

Case No.:107/16/82-

ALC4/2015 Party Name:HELLO PAINTS (P) LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 260

Case No.:19/16/82-

ALC4/2015 Party Name:MEDICLONE BIO-TECH PRIVATE LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 261

Case No.:90/16/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 262

Case No.:88/16/82-

ALC4/2015 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01408/AM16/ RLA File :34/24/040/00202/AM16/ Lic.No/Date:3410041663 05.11.2015 Defer Date:08.06.2016 Decision :Deferred. 263

Case No.:49/16/82-

ALC4/2015 Party Name:UNIMAX LABORATORIES PVT.LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01369/AM16/ RLA File :03/95/040/00500/AM16/ Lic.No/Date:0310800048 05.11.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/836/2015-PI(Norms) dated 28.4.2016, uploaded

38 264

Case No.:52/16/82-

ALC4/2015 Party Name:UNIMAX LABORATORIES PVT.LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01372/AM16/ RLA File :03/95/040/00555/AM16/ Lic.No/Date:0310800046 05.11.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/836/2015-PI(Norms) dated 28.4.2016 , uploaded 265

Case No.:37/16/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01357/AM16/ RLA File :03/94/040/00561/AM16/ Lic.No/Date:0310800114 06.11.2015 Defer Date:08.06.2016 266

Case No.:53/16/82-

ALC4/2015 Party Name:LAXMI ORGANIC INDUSTRIES LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 267

Case No.:89/16/82-

ALC4/2015 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 268

Case No.:2/16/82-

ALC4/2015 Party Name:SANO MEDICAL KITS PVT. LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 269

Case No.:34/1/82-

ALC1/2016 Party Name:GLAND PHARMA LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 270

Case No.:18/16/82-

ALC4/2015 Party Name:CAPLIN POINT LABORATORIES LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01338/AM16/ RLA File :04/24/040/00172/AM16/ Lic.No/Date:0410161300 12.11.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/786/2015-PI(Norms) dated 11.4.2016, uploaded

39 Vol.1. RA concerned may take necessary action as per decision of NC 271

Case No.:110/16/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01430/AM16/ RLA File :05/23/040/00329/AM16/ Lic.No/Date:0510396325 13.11.2015 Defer Date:08.06.2016 Decision :The Committee also decided to call for COA of item of import from the firm. 272

Case No.:106/16/82-

ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01426/AM16/ RLA File :05/24/040/00384/AM16/ Lic.No/Date:0510396340 16.11.2015 Defer Date:08.06.2016 273

Case No.:114/16/82-

ALC4/2015 Party Name:SHIVA BIOCHEM INDUSTRIES Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 274

Case No.:52/20/82-

ALC4/2015 Party Name:RELIANCE INDUSTRIES LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01635/AM16/ RLA File :03/95/040/00551/AM16/ Lic.No/Date:0310800331 19.11.2015 Defer Date:08.06.2016 Decision :Deferred. 275

Case No.:104/16/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01424/AM16/ RLA File :05/23/040/00339/AM16/ Lic.No/Date:0510396384 20.11.2015 Defer Date:08.06.2016 276

Case No.:4/20/82-

ALC4/2015 Party Name:AIMS IMPEX PVT. LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 277

Case No.:31/1/82-

ALC1/2016 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 278 Case No.:2/20/82- ALC4/2015 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:3/82- ALC4/2016 Status:Deferred

40 12.05.2016 HQ File :01/82/050/01585/AM16/ RLA File :05/24/040/00400/AM16/ Lic.No/Date:0510396400 23.11.2015 Defer Date:08.06.2016 Decision :Deferred. 279

Case No.:79/16/82-

ALC4/2015 Party Name:VENUS REMEDIES LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01399/AM16/ RLA File :22/24/040/00074/AM16/ Lic.No/Date:2210015349 23.11.2015 Defer Date:08.06.2016 280

Case No.:81/16/82-

ALC4/2015 Party Name:VENUS REMEDIES LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01401/AM16/ RLA File :22/24/040/00075/AM16/ Lic.No/Date:2210015348 23.11.2015 Defer Date:08.06.2016 281

Case No.:105/16/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01425/AM16/ RLA File :05/23/040/00356/AM16/ Lic.No/Date:0510396410 24.11.2015 Defer Date:08.06.2016 282

Case No.:33/1/82-

ALC1/2016 Party Name:INCHEM LABORATORIES PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 283

Case No.:32/16/82-

ALC4/2015 Party Name:INTERMED, Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 284

Case No.:2/1/82-

ALC1/2016 Party Name:UNIJULES LIFE SCIENCES LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 285

Case No.:23/1/82-

ALC1/2016 Party Name:UNILINK PHARMA PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01797/AM16/ RLA File :04/24/040/00170/AM16/ Lic.No/Date:0410161342 26.11.2015 Defer Date:08.06.2016 286 Case No.:57/20/82- Party Name:WANBURY Meet No/Date:3/82- Status:Deferred

41 ALC4/2015 LIMITED(FORMERLY PEARL ORGANICS LTD) ALC4/2016 12.05.2016 HQ File :01/82/050/01640/AM16/ RLA File :03/95/040/00628/AM16/ Lic.No/Date:0310800470 30.11.2015 Defer Date:08.06.2016 287

Case No.:58/20/82-

ALC4/2015 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 288

Case No.:3/1/82-

ALC1/2016 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 289

Case No.:5/1/82-

ALC1/2016 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 290

Case No.:90/20/82-

ALC4/2015 Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01673/AM16/ RLA File :03/95/040/00629/AM16/ Lic.No/Date:0310800552 01.12.2015 Defer Date:08.06.2016 291

Case No.:33/20/82-

ALC4/2015 Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 292

Case No.:88/20/82-

ALC4/2015 Party Name:LUPIN LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status: Approved HQ File :01/82/050/01671/AM16/ RLA File :03/95/040/00452/AM16/ Lic.No/Date:0310800578 02.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/716/2015-PI(Norms) dated April 2016 , uploaded Vol.1. RA concerned may take necessary action as per decision of NC 293

Case No.:54/20/82-

ALC4/2015 Party Name:MELOG SPECIALITY CHEMICALS PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File RLA File Lic.No/Date:0310800619 Defer

42 :01/82/050/01637/AM16/ :03/95/040/00631/AM16/ 03.12.2015 Date:08.06.2016 Decision :Deferred. 294

Case No.:112/20/82-

ALC4/2015 Party Name:SUPREET CHEMICALS PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 295

Case No.:89/20/82-

ALC4/2015 Party Name:MANGALAM DRUGS & ORGANICS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01672/AM16/ RLA File :03/95/040/00524/AM16/ Lic.No/Date:0310800661 04.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/864/2015-PI(Norms) dated 27th April 2016 , of HBP Vol.1. RA concerned may take necessary action as per decision of NC 296

Case No.:86/20/82-

ALC4/2015 Party Name:REANNON PHARMACEUTICALS Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01669/AM16/ RLA File :03/95/040/00494/AM16/ Lic.No/Date:0310800662 04.12.2015 Defer Date:08.06.2016 297

Case No.:62/20/82-

ALC4/2015 Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:
Approved HQ File :01/82/050/01645/AM16/ RLA File :03/95/040/00522/AM16/ Lic.No/Date:0310800711 07.12.2015 Defer Date: Decision :The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/92/2011-Ch-II dated 8.2.2016 uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per decision of NC. 298

Case No.:87/20/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 299

Case No.:35/20/82-

ALC4/2015 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01618/AM16/ RLA File :03/94/040/00480/AM16/ Lic.No/Date:0310800769 08.12.2015 Defer Date:08.06.2016 Decision :Deferred. 300

Case No.:127/16/82-

ALC4/2015 Party Name:BLUELINE FOODS (INDIA) PVT.LTD, Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File RLA File Lic.No/Date:0710109146 Defer

43 :01/82/050/01447/AM16/ :07/24/040/00267/AM16/ 08.12.2015 Date:08.06.2016 Decision :The Committee based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/656/2015-PI(Norms) dated 27.4.2016, uploaded at the end of these minutes 301

Case No.:34/20/82-

ALC4/2015 Party Name:JESONS INDUSTRIES LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Case Rejected HQ File :01/82/050/01617/AM16/ RLA File :03/94/040/00682/AM16/ Lic.No/Date:0310800771 08.12.2015 Defer Date: Decision :Firm vide letter dated 14.3.2016 has informed that said advance authorisation has been surrendered to the O/o Addl. DGFT, Mumbai on 09.03.2016 because sales order has been cancelled and firm has not imported any raw material against this authorisation. Therefore adhoc norms not required. The Committee accordingly decided to close the case. Said letter has been uploaded at the end of these minutes. 302

Case No.:85/20/82-

ALC4/2015 Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01668/AM16/ RLA File :03/95/040/00201/AM16/ Lic.No/Date:0310800751 08.12.2015 Defer Date:08.06.2016 Decision :Deferred. 303

Case No.:109/20/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01692/AM16/ RLA File :09/24/040/00505/AM16/ Lic.No/Date:0910062944 08.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/750/2015-PI(Norms) dated 04.05.2016, uploaded 304

Case No.:36/20/82-

ALC4/2015 Party Name:BAYER VAPI PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 305

Case No.:61/20/82-

ALC4/2015 Party Name:PRASOL CHEMICALS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01644/AM16/ RLA File :03/95/040/00683/AM16/ Lic.No/Date:0310800825 09.12.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/107/2011-Ch-II dated 12.01.2016, 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. 306

Case No.:67/20/82-

ALC4/2015 Party Name:MANGALAM ORGANICS LIMITED (FORMERLY DUJODWALA Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File RLA File Lic.No/Date:0310800865 Defer

44 :01/82/050/01650/AM16/ :03/95/040/00054/AM16/ 10.12.2015 Date:08.06.2016 307

Case No.:108/20/82-

ALC4/2015 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01691/AM16/ RLA File :09/24/040/00506/AM16/ Lic.No/Date:0910062961 10.12.2015 Defer Date:08.06.2016 Decision : It was observed that the quantities of import mentioned by the applicant are disproportionately high and appears to be totally unjustified. An applicant is expected to submit correct quantities of import. Accordingly, firm is to submit its version within 15 days to DGFT. 308

Case No.:59/20/82-

ALC4/2015 Party Name:PRASOL CHEMICALS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status: Approved HQ File :01/82/050/01642/AM16/ RLA File :03/95/040/00593/AM16/ Lic.No/Date:0310800879 10.12.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/107/2011-Ch-II dated 12.01.2016, 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. 309

Case No.:68/20/82-

ALC4/2015 Party Name:PRASOL CHEMICALS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status: Approved HQ File :01/82/050/01651/AM16/ RLA File :03/95/040/00684/AM16/ Lic.No/Date:0310800864 10.12.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/107/2011-Ch-II dated 12.01.2016, 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. 310

Case No.:110/20/82-

ALC4/2015 Party Name:PROCESS AGROCHEM INDUSTRIES PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : 311

Case No.:70/20/82-

ALC4/2015 Party Name:SUNSHIELD CHEMICALS LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01653/AM16/ RLA File :03/95/040/00598/AM16/ Lic.No/Date:0310800862 10.12.2015 Defer Date:08.06.2016 Decision :Deferred. 312

Case No.:39/20/82-

ALC4/2015 Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:3/82- ALC4/2016 12.05.2016 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: 07.07.2016 313

Case No.:41/20/82-

ALC4/2015 Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:3/82- ALC4/2016 12.05.2016 Status: Deferred

45 HQ File :01/82/050/01624/AM16/ RLA File :03/94/040/00648/AM16/ Lic.No/Date:0310800905 11.12.2015 Defer Date: 07.07.2016 314

Case No.:9/1/82-

ALC1/2016 Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 315

Case No.:66/20/82-

ALC4/2015 Party Name:PRIVI ORGANICS LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 316

Case No.:45/20/82-

ALC4/2015 Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 317

Case No.:63/20/82-

ALC4/2015 Party Name:MANGALAM DRUGS & ORGANICS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01646/AM16/ RLA File :03/95/040/00673/AM16/ Lic.No/Date:0310800977 14.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/864/2015-PI(Norms) dated 27th April 2016 , of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 318

Case No.:24/20/82-

ALC4/2015 Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 319

Case No.:69/20/82-

ALC4/2015 Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status: Approved
HQ File :01/82/050/01652/AM16/ RLA File :03/95/040/00661/AM16/ Lic.No/Date:0310800980 14.12.2015 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/92/2011-Ch-II dated 17.6.2015 uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per decision of NC. 320

Case No.:4/1/82-

ALC1/2016 Party Name:NAVIN FLUORINE INTERNATIONAL Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred

46 LIMITED HQ File :01/82/050/01778/AM16/ RLA File :03/95/040/00660/AM16/ Lic.No/Date:0310800993 14.12.2015 Defer Date:08.06.2016 Decision :Deferred. 321

Case No.:64/20/82-

ALC4/2015 Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved
HQ File :01/82/050/01647/AM16/ RLA File :03/95/040/00702/AM16/ Lic.No/Date:0310801034 15.12.2015 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/92/2011-Ch-II dated 20.10.2015 uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per decision of NC. 322

Case No.:65/20/82-

ALC4/2015 Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved
HQ File :01/82/050/01648/AM16/ RLA File :03/95/040/00703/AM16/ Lic.No/Date:0310801051 15.12.2015 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/92/2011-Ch-II dated 8.2.2016 uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per decision of NC. 323

Case No.:49/20/82-

ALC4/2015 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 324

Case No.:10/1/82-

ALC1/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 325

Case No.:44/20/82-

ALC4/2015 Party Name:CELOGEN PHARMA PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01627/AM16/ RLA File :03/94/040/00720/AM16/ Lic.No/Date:0310801132 16.12.2015 Defer Date:08.06.2016 326

Case No.:74/20/82-

ALC4/2015 Party Name:CIPLA LIMITED. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01657/AM16/ RLA File :03/94/040/00684/AM16/ Lic.No/Date:0310801092 16.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/862/2015-PI(Norms) dated 10.05.2016, uploaded

47 327

Case No.:75/20/82-

ALC4/2015 Party Name:CIPLA LIMITED. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01658/AM16/ RLA File :03/94/040/00695/AM16/ Lic.No/Date:0310801091 16.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/862/2015-PI(Norms) dated 10.05.2016, uploaded 328

Case No.:46/20/82-

ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 329

Case No.:120/20/82-

ALC4/2015 Party Name:MAITHRI LABORATORIES (P) LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01703/AM16/ RLA File :09/24/040/00524/AM16/ Lic.No/Date:0910062974 16.12.2015 Defer Date:08.06.2016 330

Case No.:23/20/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 331

Case No.:8/20/82-

ALC4/2015 Party Name:SHREE BANKEY BEHARI LAL BOARD MILLS Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01591/AM16/ RLA File :05/24/040/00427/AM16/ Lic.No/Date:0510396637 16.12.2015 Defer Date:08.06.2016 Decision :Deferred. 332

Case No.:135/16/82-

ALC4/2015 Party Name:METROCHEM API PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status: Approved
HQ File :01/82/050/01455/AM16/ RLA File :09/24/040/00534/AM16/ Lic.No/Date:0910062981 17.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/557/2015-(PI-Norms) dated 12.04.2016 , 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.

333

Case No.:136/16/82-

ALC4/2015 Party Name:METROCHEM API PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:
Approved
HQ File :01/82/050/01456/AM16/ RLA File :09/24/040/00533/AM16/ Lic.No/Date:0910062980 17.12.2015 Defer Date:

48 Pharmaceuticals forwarded vide O.M. No.35011/557/2015-(PI-Norms) dated 12.04.2016 , 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.

334

Case No.:8/1/82-

ALC1/2016 Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 335

Case No.:73/20/82-

ALC4/2015 Party Name:CIPLA LIMITED. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01656/AM16/ RLA File :03/94/040/00697/AM16/ Lic.No/Date:0310801217 18.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/861/2015-PI(Norms) dated 10.05.2016, uploaded 336

Case No.:83/1/82-

ALC1/2016 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 337

Case No.:14/20/82-

ALC4/2015 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 338

Case No.:30/1/82-

ALC1/2016 Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01804/AM16/ RLA File :07/24/040/00198/AM16/ Lic.No/Date:0710109193 22.12.2015 Defer Date: Pharmaceutical forwarded vide O.M.No.35011/434/2015-PI(Norms) dated 13.10.2015 uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per decision of NC. 339

Case No.:15/20/82-

ALC4/2015 Party Name:CELOGEN PHARMA PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01598/AM16/ RLA File :03/94/040/00721/AM16/ Lic.No/Date:0310801298 22.12.2015 Defer Date:08.06.2016 340 Case No.:19/20/82- ALC4/2015 Party Name:LAXMI ORGANIC INDUSTRIES Meet No/Date:3/82- ALC4/2016 Status:Deferred

49 LTD., 12.05.2016 HQ File :01/82/050/01602/AM16/ RLA File :03/95/040/00009/AM16/ Lic.No/Date:0310801275 22.12.2015 Defer Date:08.06.2016 Decision :Deferred. 341

Case No.:20/20/82-

ALC4/2015 Party Name:LAXMI ORGANIC INDUSTRIES LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 342

Case No.:111/20/82-

ALC4/2015 Party Name:PARENTRAL DRUGS INDIA LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01694/AM16/ RLA File :56/24/040/00045/AM16/ Lic.No/Date:5610004780 22.12.2015 Defer Date:08.06.2016 343

Case No.:48/20/82-

ALC4/2015 Party Name:ALCHEMIE LABORATORIES Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 344

Case No.:17/20/82-

ALC4/2015 Party Name:CIPLA LIMITED. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01600/AM16/ RLA File :03/94/040/00767/AM16/ Lic.No/Date:0310801358 28.12.2015 Defer Date: 345

Case No.:18/20/82-

ALC4/2015 Party Name:CIPLA LIMITED. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01601/AM16/ RLA File :03/94/040/00781/AM16/ Lic.No/Date:0310801341 28.12.2015 Defer Date: 346

Case No.:71/20/82-

ALC4/2015 Party Name:CIPLA LIMITED. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01654/AM16/ RLA File :03/94/040/00698/AM16/ Lic.No/Date:0310801355 28.12.2015 Defer Date:08.06.2016

50 347

Case No.:72/20/82-

ALC4/2015 Party Name:CIPLA LIMITED. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01655/AM16/ RLA File :03/94/040/00768/AM16/ Lic.No/Date:0310801340 28.12.2015 Defer Date: 348

Case No.:16/20/82-

ALC4/2015 Party Name:FINE ORGANIC INDUSTRIES PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01599/AM16/ RLA File :03/94/040/00780/AM16/ Lic.No/Date:0310801349 28.12.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/129/2011-Ch-II dated 4.3.2016 , 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. 349

Case No.:131/16/82-

ALC4/2015 Party Name:HETERO LABS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01451/AM16/ RLA File :09/24/040/00578/AM16/ Lic.No/Date:0910063038 28.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/823/2015-PI(Norms) dated April 2016, uploaded 350

Case No.:86/19/82-

ALC4/2015 Party Name:RUBY FRAGRANCE PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved
HQ File :01/82/050/01567/AM16/ RLA File :35/24/040/00048/AM16/ Lic.No/Date:3510044853 29.12.2015 Defer Date: Decision :Approved in NC 02/AM 17 dated 26.04.2016 351

Case No.:102/20/82-

ALC4/2015 Party Name:STERMONE CHEMICALS PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01685/AM16/ RLA File :34/24/040/00243/AM16/ Lic.No/Date:3410041764 29.12.2015 Defer Date:08.06.2016 352

Case No.:80/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 353

Case No.:81/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016

51 Decision :Deferred. 354

Case No.:22/20/82-

ALC4/2015 Party Name:S M B CORPORATION OF INDIA Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 355

Case No.:84/20/82-

ALC4/2015 Party Name:SIRMAXO CHEMICALS PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 356

Case No.:116/20/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01699/AM16/ RLA File :05/24/040/00463/AM16/ Lic.No/Date:0510397108 30.12.2015 Defer Date:08.06.2016 357

Case No.:47/20/82-

ALC4/2015 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 358

Case No.:92/20/82-

ALC4/2015 Party Name:CIPLA LIMITED. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01675/AM16/ RLA File :03/94/040/00696/AM16/ Lic.No/Date:0310801442 31.12.2015 Defer Date: 359

Case No.:98/20/82-

ALC4/2015 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01681/AM16/ RLA File :05/23/040/00338/AM16/ Lic.No/Date:0510397164 31.12.2015 Defer Date:08.06.2016 360

Case No.:99/20/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 361 Case No.:101/20/82- Party Name:SONGWON Meet No/Date:3/82- Status:Deferred

52 ALC4/2015 SPECIALTY CHEMICALS INDIA PVT. LTD. ALC4/2016 12.05.2016 HQ File :01/82/050/01684/AM16/ RLA File :34/24/040/00226/AM16/ Lic.No/Date:3410041775 31.12.2015 Defer Date:08.06.2016 Decision :Deferred. 362

Case No.:119/20/82-

ALC4/2015 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 363

Case No.:77/20/82-

ALC4/2015 Party Name:CIPLA LIMITED. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved
HQ File :01/82/050/01660/AM16/ RLA File :03/94/040/00788/AM16/ Lic.No/Date:0310801491 01.01.2016 Defer Date: 364

Case No.:91/20/82-

ALC4/2015 Party Name:CIPLA LIMITED. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01674/AM16/ RLA File :03/94/040/00789/AM16/ Lic.No/Date:0310801492 01.01.2016 Defer Date: 365

Case No.:118/20/82-

ALC4/2015 Party Name:AMI LIFESCIENCES P LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01701/AM16/ RLA File :34/24/040/00256/AM16/ Lic.No/Date:3410041779 04.01.2016 Defer Date:08.06.2016 366

Case No.:104/20/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 367

Case No.:82/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 368 Case No.:83/20/82- Party Name:YASHO Meet No/Date:3/82- Status:Deferred

53 ALC4/2015 INDUSTRIES PVT.LTD. ALC4/2016 12.05.2016 HQ File :01/82/050/01666/AM16/ RLA File :03/95/040/00749/AM16/ Lic.No/Date:0310801521 04.01.2016 Defer Date:08.06.2016 Decision :Deferred. 369

Case No.:105/20/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 370

Case No.:78/20/82-

ALC4/2015 Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 371

Case No.:26/20/82-

ALC4/2015 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 372

Case No.:7/1/82-

ALC1/2016 Party Name:PRIVI ORGANICS LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 373

Case No.:76/20/82-

ALC4/2015 Party Name:AIMS IMPEX PVT. LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :deferred. 374

Case No.:103/20/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 375

Case No.:6/1/82-

ALC1/2016 Party Name:MEDISPRAY LABORATORIES PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016

54 376

Case No.:32/1/82-

ALC1/2016 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01806/AM16/ RLA File :05/24/040/00431/AM16/ Lic.No/Date:0510397230 07.01.2016 Defer Date:08.06.2016 Decision :deferred. 377

Case No.:95/20/82-

ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 378

Case No.:79/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 379

Case No.:21/20/82-

ALC4/2015 Party Name:SHREE LIFE SCIENCES PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 380

Case No.:19/1/82-

ALC1/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01793/AM16/ RLA File :04/24/040/00214/AM16/ Lic.No/Date:0410161494 11.01.2016 Defer Date:08.06.2016 381

Case No.:60/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 382

Case No.:61/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 383

Case No.:48/1/82-

ALC1/2016 Party Name:INDO AMINES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred

55 HQ File :01/82/050/01822/AM16/ RLA File :03/94/040/00785/AM16/ Lic.No/Date:0310801728 12.01.2016 Defer Date:08.06.2016 Decision :Deferred. 384

Case No.:82/1/82-

ALC1/2016 Party Name:PRIVI ORGANICS LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 385

Case No.:62/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 386

Case No.:66/1/82-

ALC1/2016 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 387

Case No.:64/1/82-

ALC1/2016 Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01838/AM16/ RLA File :03/94/040/00840/AM16/ Lic.No/Date:0310801857 18.01.2016 Defer Date:08.06.2016 Decision :Deferred. 388

Case No.:22/1/82-

ALC1/2016 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01796/AM16/ RLA File :04/24/040/00220/AM16/ Lic.No/Date:0410161521 18.01.2016 Defer Date:08.06.2016 389

Case No.:79/1/82-

ALC1/2016 Party Name:PRIVI ORGANICS LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 390

Case No.:80/1/82-

ALC1/2016 Party Name:SUNSHIELD CHEMICALS LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01854/AM16/ RLA File :03/95/040/00771/AM16/ Lic.No/Date:0310801856 18.01.2016 Defer Date:08.06.2016 Decision :Deferred.

56 391

Case No.:63/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 392

Case No.:65/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 393

Case No.:59/1/82-

ALC1/2016 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 394

Case No.:114/20/82-

ALC4/2015 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 395

Case No.:77/1/82-

ALC1/2016 Party Name:MEDISPRAY LABORATORIES PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 396

Case No.:36/1/82-

ALC1/2016 Party Name:SI GROUP INDIA LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01810/AM16/ RLA File :03/95/040/00779/AM16/ Lic.No/Date:0310801890 19.01.2016 Defer Date:08.06.2016 Decision :Deferred. 397

Case No.:113/20/82-

ALC4/2015 Party Name:STERMONE CHEMICALS PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01696/AM16/ RLA File :34/24/040/00177/AM16/ Lic.No/Date:3410041821 19.01.2016 Defer Date:08.06.2016 Decision :Deferred. 398

Case No.:76/1/82-

ALC1/2016 Party Name:TITAN LABORATORIES PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File RLA File Lic.No/Date:0310801892 Defer

57 :01/82/050/01850/AM16/ :03/95/040/00790/AM16/ 19.01.2016 Date:08.06.2016 399

Case No.:50/1/82-

ALC1/2016 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01824/AM16/ RLA File :03/94/040/00861/AM16/ Lic.No/Date:0310801928 20.01.2016 Defer Date:08.06.2016 Decision :Deferred. 400

Case No.:68/1/82-

ALC1/2016 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 401

Case No.:106/20/82-

ALC4/2015 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 402

Case No.:38/1/82-

ALC1/2016 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 403

Case No.:115/20/82-

ALC4/2015 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01698/AM16/ RLA File :34/24/040/00268/AM16/ Lic.No/Date:3410041823 21.01.2016 Defer Date:08.06.2016 404

Case No.:49/1/82-

ALC1/2016 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : Deferred . 405

Case No.:47/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : Deferred . 406 Case No.:67/1/82- ALC1/2016 Party Name:INDOCO REMEDIES LIMITED Meet No/Date:3/82- ALC4/2016 Status:Deferred

58 12.05.2016 HQ File :01/82/050/01841/AM16/ RLA File :03/94/040/00880/AM16/ Lic.No/Date:0310802014 22.01.2016 Defer Date:08.06.2016 407

Case No.:24/1/82-

ALC1/2016 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01798/AM16/ RLA File :04/24/040/00210/AM16/ Lic.No/Date:0410161548 22.01.2016 Defer Date:08.06.2016 408

Case No.:97/20/82-

ALC4/2015 Party Name:SHREE BANKEY BEHARI LAL AROMATICS Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 409

Case No.:96/20/82-

ALC4/2015 Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 410

Case No.:51/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : Deferred . 411

Case No.:52/1/82-

ALC1/2016 Party Name:INDO AMINES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 412

Case No.:53/1/82-

ALC1/2016 Party Name:DR. ACHARYA LABORATORIES PVT. LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01827/AM16/ RLA File :03/94/040/00881/AM16/ Lic.No/Date:0310802057 27.01.2016 Defer Date:08.06.2016 413

Case No.:27/1/82-

ALC1/2016 Party Name:BODAL CHEMICALS LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016

59 414

Case No.:44/1/82-

ALC1/2016 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 415

Case No.:40/1/82-

ALC1/2016 Party Name:MAGNOLIA LIMITED. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 416

Case No.:35/1/82-

ALC1/2016 Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 417

Case No.:37/1/82-

ALC1/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 418

Case No.:43/1/82-

ALC1/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 419

Case No.:11/1/82-

ALC1/2016 Party Name:GANGWAL CHEMICALS (P) LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status: Approved HQ File :01/82/050/01785/AM16/ RLA File :03/94/040/00919/AM16/ Lic.No/Date:0310802255 05.02.2016 Defer Date:
Decision :The Committee decided to ratify norms on net to net basis without wastage under

Para 4.07 of HBP. RA concerned may take further necessary action as per decision of NC. At the

time of closure, net content in export may be calculated by the RA. 420

Case No.:58/1/82-

ALC1/2016 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 421 Case No.:42/1/82- ALC1/2016 Party Name:CELOGEN PHARMA PVT.LTD. Meet No/Date:3/82- ALC4/2016 Status:Deferred

60 12.05.2016 HQ File :01/82/050/01816/AM16/ RLA File :03/94/040/00929/AM16/ Lic.No/Date:0310802331 08.02.2016 Defer Date:08.06.2016 422

Case No.:69/1/82-

ALC1/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 423

Case No.:74/1/82-

ALC1/2016 Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision : 424

Case No.:39/1/82-

ALC1/2016 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 425

Case No.:75/1/82-

ALC1/2016 Party Name:BLISS GVS PHARMA LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01849/AM16/ RLA File :03/94/040/00948/AM16/ Lic.No/Date:0310802382 09.02.2016 Defer Date:08.06.2016 426

Case No.:71/1/82-

ALC1/2016 Party Name:HALCYON LABS PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01845/AM16/ RLA File :03/94/040/00916/AM16/ Lic.No/Date:0310802390 09.02.2016 Defer Date:08.06.2016 427

Case No.:72/1/82-

ALC1/2016 Party Name:HALCYON LABS PVT. LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01846/AM16/ RLA File :03/94/040/00915/AM16/ Lic.No/Date:0310802387 09.02.2016 Defer Date:08.06.2016 428

Case No.:45/1/82-

ALC1/2016 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 429 Case No.:70/1/82- Party Name:ENCUBE Meet No/Date:3/82- Status:Deferred

61 ALC1/2016 ETHICALS PVT LTD ALC4/2016 12.05.2016 HQ File :01/82/050/01844/AM16/ RLA File :03/94/040/00935/AM16/ Lic.No/Date:0310802452 10.02.2016 Defer Date:08.06.2016 430

Case No.:41/1/82-

ALC1/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 431

Case No.:78/1/82-

ALC1/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 432

Case No.:55/1/82-

ALC1/2016 Party Name:UNIMAX LABORATORIES PVT.LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/01829/AM16/ RLA File :03/95/040/00846/AM16/ Lic.No/Date:0310802440 10.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/836/2015-PI(Norms) dated 28.04.2015 , of HBP Vol.1. RA concerned may take necessary action as per decision of NC 433

Case No.:73/1/82-

ALC1/2016 Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 434

Case No.:26/1/82-

ALC1/2016 Party Name:UMA ENTERPRISE Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 Decision :Deferred. 435

Case No.:56/1/82-

ALC1/2016 Party Name:ZIM LABORATORIES LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 436

Case No.:17/1/82-

ALC1/2016 Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File RLA File Lic.No/Date:0410161613 Defer

62 :01/82/050/01791/AM16/ :04/24/040/00229/AM16/ 17.02.2016 Date:08.06.2016 Decision :Deferred. 437

Case No.:57/1/82-

ALC1/2016 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 438

Case No.:1/20/82-

ALC4/2015 Party Name:DIVIS LABORATORIES LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01584/AM16/ RLA File :09/24/040/00689/AM16/ Lic.No/Date:0910063311 22.02.2016 Defer Date:08.06.2016 439

Case No.:1/1/82-

ALC4/2016 Party Name:GRANULES INDIA LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:approved HQ File :01/82/050/01860/AM16/ RLA File :09/24/040/00687/AM16/ Lic.No/Date:0910063325 24.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/746/2015-PI(Norms) dated 07.03.2016 , of HBP Vol.1. RA concerned may take necessary action as per decision of NC 440

Case No.:18/1/82-

ALC1/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01792/AM16/ RLA File :04/24/040/00248/AM16/ Lic.No/Date:0410161671 01.03.2016 Defer Date:08.06.2016 441

Case No.:20/1/82-

ALC1/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01794/AM16/ RLA File :04/24/040/00247/AM16/ Lic.No/Date:0410161672 01.03.2016 Defer Date:08.06.2016 442

Case No.:21/1/82-

ALC1/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01795/AM16/ RLA File :04/24/040/00246/AM16/ Lic.No/Date:0410161670 01.03.2016 Defer Date:08.06.2016 443

Case No.:19/2/82-

ALC4/2016 Party Name:WANBURY LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/00019/AM17/ RLA File :03/95/040/00912/AM16/ Lic.No/Date:0310803062 04.03.2016 Defer Date: Decision : Approved in Meeting No.02/AM17 dated 26.4.2016

63 444

Case No.:21/2/82-

ALC4/2016 Party Name:WANBURY LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:approved
HQ File :01/82/050/00021/AM17/ RLA File :03/95/040/00917/AM16/ Lic.No/Date:0310803064 04.03.2016 Defer Date: Decision : Approved in Meeting No.02/AM17 dated 26.4.2016 445

Case No.:39/2/82-

ALC4/2016 Party Name:WANBURY LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/00039/AM17/ RLA File :03/95/040/00915/AM16/ Lic.No/Date:0310803069 04.03.2016 Defer Date: Decision : Approved in Meeting No.02/AM17 dated 26.4.2016 446

Case No.:40/2/82-

ALC4/2016 Party Name:WANBURY LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 Status: Approved HQ File :01/82/050/00040/AM17/ RLA File :03/95/040/00908/AM16/ Lic.No/Date:0310803066 04.03.2016 Defer Date: Decision : Approved in Meeting No.02/AM17 dated 26.4.2016 447

Case No.:13/1/82-

ALC1/2016 Party Name:ONEIRO CHEMICALS LTD Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Deferred
HQ File :01/82/050/01787/AM16/ RLA File :34/24/040/00286/AM16/ Lic.No/Date:3410041972 14.03.2016 Defer Date:08.06.2016 Decision :Deferred. 448

Case No.:15/1/82-

ALC1/2016 Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 449

Case No.:14/1/82-

ALC1/2016 Party Name:DIVIS LABORATORIES LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 450

Case No.:85/1/82-

ALC1/2016 Party Name:DIVIS LABORATORIES LTD., Meet No/Date:3/82- ALC4/2016 12.05.2016 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:08.06.2016 451 CaseNo.:26/5/82- ALC4/2014 Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, Meet No/Date:3/82- ALC4/2016 12.05.2016 Status:Approved HQ File :01/82/050/00343/AM15/ RLA File :07/24/040/00469/AM14/ Lic.No/Date:0710103055 20.03.2014 Defer Date:

64 Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceutical forwarded vide O.M.No.35011/434/2015-PI(Norms) dated 13.10.2015 uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per decision of NC. Manual Agenda of NC Meeting No. 3/82/2017 Scheduled to be held on 12.05.2016

Case No. B- 01

M.No.3/AM-17 Date 12.05.2016 M/s. IPCA Laboratories Ltd File No. 01/82/050/00354/AM14 RLA No 03/94/040/00101/AM14 Adv.Auth. No. 0310734943 dated 20.05.2013 Decision: The Committee considered this case for revision of norms under para 4.07 of HBP as per agenda. The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.14/82 dated 22.12.2014, 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 take necessary action as per decision of NC

Case No. B- 02

M.No.3/AM-17 Date 12.05.2016 M/s. Mangalam Drugs & Organics Ltd File No. 01/82/050/00476/AM16 RLA No 03/95/040/00998/AM15 Adv.Auth. No. 0310794278 dated 02.03.2015 Decision: The Committee considered this case for revision of norms under para 4.07 of HBP as per agenda The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/864/2015-PI(Norms) dated 27th April 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

Case No. B- 03

M.No.3/AM-17 Date 12.05.2016 M/s. Mangalam Drugs & Organics Ltd File No. 01/82/050/00249/AM16 RLA No 03/95/040/00828/AM15 Adv.Auth. No. 0310793022 dated 16.01.2015 Decision: The Committee considered this case for revision of norms under para 4.07 of HBP as per agenda The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/864/2015-PI(Norms) dated 27th April 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

Case No. B- 04

M.No.3/AM-17 Date 12.05.2016 M/s. Herbochem File No. 01/82/050/01366/AM15 RLA No 09/24/040/00572/AM15 Adv.Auth. No. 0910061552 dated 21.01.2015 Decision: The Committee considered this case for revision of norms under para 4.07 of HBP as per agenda. The Committee decided to call for COA of imported roots for relevant consignment and other

65 relevant data/documents as may be available with the applicant and deferred the case.

Case No. B- 05

M.No.3/AM-17 Date 12.05.2016 M/s. IPCA Laboratories Ltd File No. 01/82/050/01221/AM12 RLA No 03/94/040/00712/AM12 Adv.Auth. No. 0310665724 dated 17.11.2011 Decision: The Committee considered this case for amendment in description of export product from Methyl Testosterone to Testosterone under para 4.07 of HBP as per agenda. Firm may explain whether the export product Methyl testosterone and Testosterone both are chemically different or same. The Committee decided to defer the case.

Case No. B- 06

M.No.3/AM-17 Date 12.05.2016 M/s. AVA Chemicals Pvt Ltd File No. 01/82/050/01017/AM14 RLA No 03/94/040/00786/AM14 Adv.Auth. No. 0310763107 dated 23.12.2013 Decision: The Committee considered this case for correction in the quantity of import item Ethylene Diamine Tetra acetic acid.......0.0730kg to Ethylene Diamine Tetra acetic acid..........0.730kg for export of 1kg as per agenda. The Committee noted that % of EDTA in composition of export is not mentioned. The committee accordingly, decided to call for the above and defer the case.

Case No. B- 07

M.No.3/AM-17 Date 12.05.2016 M/s. Bliss GVS Pharma Ltd File No. 01/82/050/00475/AM14 RLA No 03/94/040/00240/AM14 Adv.Auth. No. 0310737875 dated 17.06.2013 Decision: The Committee considered this case for addition export product No.2 in the ratified norms as per agenda. The Committee decided to add the export product No. 2 to read as “Indomethacin 100mg Suppository Net content of import item used – Indomethacin BP-98.035kgs”. RA concerned may take further necessary action as per decision of NC.


.-
h'. No.350 I 1 1434/2015-Pi (l{orms) Govemment r:f Inclia Ministry of Chemical & Fertilizers Department of Pharmaceuticals Udyog Bhawan, New Delhi, the |$ October, 2015

Subject: - Fixarion of norms uncter rf;ffiffirffi.

of Proceclures (vol.l) 2009-14 case of M/s Mangalam Drugs & Organics Ltd. 'l'ire unciersignec{ is clirectecl to refur to DGFT U.O.No. 011821501476/AM-l6lDeS-3/528 dated tlre 08/A71fi vicle which application from Mls. Mangalam Drugs & Organics Ltd was sent to this Department fbr fixation of norms under para: 4.7 for the export of Tenofovir Disoproxil Fumarate. Tlris department has examined the matter and the following norms are tirrnislred under para 4.7 of Hand Book of Procednres (Vol.l) 2009'14' h:rport Itetn Qty. Recummendsd lcg/kg. (R)-9-(2-Phosphonyl Methoxy Propyl) Adenine 0,769 9/^h 5 llor s38,lt/ &lq^a' ['v"t (Barnali Khastfir) Uncler Secretary to the Covenunent of India Phone:23071 162 Directorate General of Foreign Trade, Depa$ment of Commerce. (Shri M.V. Singh, FTDO), Udyog Bhawan, New Delhi !.*c, ― ‐

https://maii.gcv.idiwc-siatrcilayoLtlshell.htmi?iang-gn.isg3.O.1.2.O i5121$A7 Applicatior of i″s PanacOa 8:otec Lid,彗G FT Ref: 01′82/050′ 01517ノノヽM‐ 16ノDES― ll:ノ652 dated 16.02.2016 Date: 02/29/1604:34 PM ´ Fromi "N tln Kumar」all DBT"く r、link.iain@nic in> Mahendra∨ ik,m sngLFiIQΩ ≦ ■c3二 d91@pに lo2__ _____―

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ヽ F. No 35011164712015-Pl (Norms) Government of lndia ns ,So'V Subject: - DGFTRルリ ) udyog Bhawan,New Delhi, Datedi 28 April,2016 0ffice Memorandum 01/82/50/92/AM-15/DES-3/980 dated the 30/9/15 01/82/50/190/ARll-15/DES… 3/981 dated the 7′ 8/15, 01/82/50/997/AM… 13/1DES-3′ 983 dated the 30/9/15 01ノ82/50/43/AM-12/DES-3/984 dated the 30/9/15 01/82/50/162′ANl-14/DES… 3/985 dated the 30/9/15 01/82′50/995/AM-13/DES… 3/986 dated the 30/9/15 01/82′50′847/AM… 13/1DES-3/987 dated the 30/9/15 01/82/50/241/AM-14/DES-3/988 dated the 30/9/15. 01/82/50/44/AM‐ 12/DES-3/989 dated the 30/9/15 01/82′50/306/AM-13/1DES-3/990 dated the 30/9/15 びイに♂仏〕多 ル上ゲ“ い 3) 4) 5) 6) 7) 8) -9) 10) The undersigned is directed to refer to DGFT references given above vide whtch submissions made by M/s Mylan Labs Ltd. was sent to this Department for fixation of norms for different export products. This department has examined the matter and it is stated that these cases pertains to the period 2o1o-11 to 2013-14 and in all these cases, the firm was advised to furnish complete technical details as per appendix-33 ard the past production-consumption certificate duly certified by Central ixcise Authorities. The firm failed to give these details in the past and Norms-Committee decicled to reject these cases for non-submission of details. The firm, in the present submission also, have not given the requisite technical details as per Appendix-33 and have not furnished past production vis-d-vis actual consumption of imported inputs duly certified by Central Excise Authorities' In view of above, no furiher action can be taken at our end and Norms-Committee may take a finalview. 2. This issues with the approval of competent authority' (Ralkumar) Under Secretary to the Government oflndia PH:-23071162 Directorate(3eneral of Foreign Trade, Department of Commerce, (ShH M V Singh,FTDO), Udyo9 Bhawan,New Delhi

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γ ′ F. No.350'1 1166212015-Pl (Norms) Government of lndia Udyog Bhawan, New Delhi, Dated: 21 March, 2016 Office Memorandum

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

14 Case of M/s Jodas ExPoim Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/850/AM- 16/DES-3/889 dated tre 3/9i15 vide which application from M/s Jodas Expoim Pvt Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of cefoperezone & sulabactum for injection 1gm. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- DGFT is advised to call copy of the DML from the firm alongwith coA of the imported item from the foreign supPlier. 2. This issues with the approval of competent authority. (Ralkumar) Under Secretary to the Government ofindia PH: 23071162 Directorate Cenera1 0f Foreign Trade, Depanment Of COmmerCe, (Sh面M V Singh,FTDO), Udyog Bhawan,New Delhi

\ 泌f F. No.350 1 1 17 451201 5-Pl (Norms) Government of lndia Dated: April, 2016 Office Memorandum Subject. - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2OO9-14 Case of M/s Covalent Labs Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182150112401AM- 16/DES-3/1369 dated the 21112115 vide which application from M/s Covalent Labs Pvt. Ltd. was sent to this Department for fixation of norms under para. 4.7 for the export of Cefotaxime Sodium. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- W:- DGFT is advised to call all industry production-consumption data duly certified by Central Excise Authorites through pharmexcil to revise the SION A-2027 for above export product 2. (Raikumar) Under Secretary to the(3overnment oflndia PH:… 23071162 S.No. lmpoft ltem Norms Recommended for 1ko Export 7 amino cephalosporonic acid 0 ACA) 0.741kq 2 MAEM 1.025kq 3 Acetone 1.426kq 4 Methanol 1.924kq 5 Activated carbon 0.030kq

ハ ヘ ヽ F No.35C1 1.t7571201r-Pl (Norms) Government of lndta Udyog Bhawan,New Delhi, Dated: 2,May 2016 Office Memorandum Subject. - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s Sriam Labs PvL Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011187/AM- 16/DES-3/1272 dated the 16112t15 vide which application from M/s Sriam Labs Pvt. Ltd. was sent to this Department for fixation of norms under para'. 4.7 for the export of {i.s 4R)-4-[(?-arnino-6-chloro-5-farmamido-4'pyrimidinyl) aminoJ-2-cyclopentene- 1-r;lcrhanol infC;. Ti,,o Cupartment has examine,J iite nt;ttl; and tne iollowing rlo,rlls are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14"- S No lmport ltem Norms Recornmended for 1kq Export

azaOiiv clol2 .2 .1 I h e pt- 5 - e n - 3 - o n e (V i nqgleglg-D 1.41kg 2 Sodium borohydride 0.226kg 3 N―(2-amino-4,6-dichloro-5-pyttmidinyl)formamide (FADCP) 0 764kg 4 D(―)tartattc acid 5 L(十)tartaric acid Under Secretary to the(3overnment oflndia PH:-23071162 Directorate(3eneral of Foreign Trade, Depanment Of Commerce, (Shtt M・V.Singh,FTDO), 場 / (Rajnrrrnur) /

l'7

ヘ F r.lo j5011177112015-Pl (Norms) Governntent of lndta Dated: 11 APril,2016 Office Memorandum

subject: - Fixation of norms under para 4.7 of Hand Book of procedures (Vol.l) 2009-14

Case of M/s Medicamen Organics Ltd' TheundersignedisdirectedtorefertoDGFTU.o'No.o1l82l50l117B|AM- 16/DES-3/1332 oaieo the l}llzlls vide which application from M/s Medicamen organics Ltd. was sent to this Department for fixation of norms under para: 4'7 for the .-,.i_.c:: .,.i i:r.rr{-.irs sirlfatc 30cmg - Fc!ic Acid Tablet. This dqparimeot has examined i.he matic; and tile luiiuwii,!:t3i'l-rri ate fUrrrisileC'indel"p?rn 4'" 9; l-16;{ Bil'ir ''r' Procedures (Vol. l) 2009-1 4"- 2. (Rafkumar) Under Secretary to the ucvetilment ot lndta PH'.- 23071162 Directorate General of Foreign Trade' Norms Recommended for 1 No.Tablet lmport ltem Export Product fantet Ferrous SLrlfate 300mq + Folic Actd_1 Tablet Fenous Sulfate +Folic Acid 0 4m

σ多〕 T3名 F Nlc 3501 1t76612015-Pl (Norms) Government ot lndia Dated: 26 APril, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol'l) 2009-14

Case of M/s Zim Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011150/AM- 16/DES-3/1284 daled the 16112t15 vide which application from M/s Zim Labs Ltd' was sent to this Department for fixation of norms under para. 4.7 for the export of Azithrarnycin for oral suspension 200mgl5ml. This department has examined the matter and the foliowing iioin'ls 3r€ i,irnrsheci rinder para 4.7 of t.land Bock cf Procedures (Vol.l) 2009-1 4.- lmport ltem Norms Recommended for 1kq Export S.No. 1 Azithromvcin USP ´ヽ\ 0.078kg 2. Under Secretary to the(3overnment oflndia PH:-23071162 Dlrectorate General of Foreign Trade, Departmur rl of Commerce, 子 可 ハ

F No.3501 1/6901201s-Pl (Norms) Government of lndia "4-.--' 1 V-\t1/' Dated: 21 March,2016 Office Memorandum

subject: - Fixation of norms under para 4.7 of Hand Book of procedures (vol.l) 2o0g-

'14 Case of M/s Alphamed Formulations pvt. Ltd. The undersigned is directed to refer to DGFT U.o.No. oltg2tsot}lglAM- 16iDES-3/1005 dated the 27t1ot1s vide which application from M/s Alphamed Formulations Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Guronsan c Effervescent rablets. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- DGfr is advised to call copy of master-Batch formula from the firm duly certified by Q.C. lncharge. 2. (Rajkumar) Under Secretary to the Government of lndia PH.- 23071162 (Shri M V. Singh, FTDO),

\q?- Dated: 26 APril, 2016 Office Memorandum

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

14 Case of M/s Sun Pharmaceutical lndustries Ltd. The undersigned is directed to refer to DGFT U.O.No. 01lB2l50l1295lAM' 16|DES-311237 dated the 15112t15 vide which application from M/s Sun Pharmaceutical lndustries Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of clarithromycin carbomer Granules 43.75o/ol44o/o. This department has examined the matter and the following norms are furnished under

para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:-

DGFT is advised to call following details from the firm viz:-

  1. Copy of valid DML for above export product.
  2. Copy of Master-Batch formula duly certified by Q.C. incharge'

(Rajkumar) PH- 23071162 (Shri M V. Singh, FTDO), F. No 3501 1178112O15-Pl (Norms) Government of lndia ´

F. No.350 11t750t201s-Pl (Norms) I Government of lndia Dated: 3, May 2016 Office Memorandum 14 Case of M/s Suven Life Sciences Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501129614M- 16/DES-3/1236 dated the 15112115 vide which application from M/s Suven Life Sciences Ltd. was sent to this Department for fixation of norms under para: 4.7 for lhe export of (7R,7aS)-7-ethyl-3,3-dimethyl tetrahydro pyrrolo[1 ,2-C]oxazol-5(1H)-one. This department has examined the matter and the following norms are furnished under

para 4.7 of Hand Book of Procedures (Vol.l) 2009-14.-

(Rajkumar) PH- 23071162 ― I J S.No. lmport ltem Norms Recommended for 1kq Export Allyl methyl carbonate 1.828kq 2 Tetrahvdrofuran 5。716kg 3 Pa‖ adium (||)acetate 0.1 52kq

ニ ケ F No 35011/780/2015-PI(Norms) Government oflndia Ministry of Chemical&Fertilizers Department of Pharrnaceuticals Dated. 11 APril, 2016 Office Memorandum Subject. - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s RA Chem Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011269/AM- 16/DES-3/Q3a dat6d the 15112t15 vide which application from M/s RA Chem pharma Ltd. was sent to this Department for fixation of norms under para. 4.7 for the export of Mel everine Spheroids 17%. This department has examined the matter and the follc.,vrng norms are fuinislred under para 4.7 of Hand Book of Proceclilres 1Vol.l) 2009- 14.- 2 (Ralkumar) Under Secretary to the(3overnment oflndia PH:-23071162 Directorate Genera1 0f Foreign Trade, (Sh面M∨Singh,FTDO), S No. 1 lmport ltem 1kq Export Mebeverine Hcl 0.1717kg ジ

氏 |

a,/ J tL,T r No.35011 17431?-01 s-Pl (Norms) Government of lndia Dated: April,2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14

Case of M/s Maithri Labs Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182150112321A.M- 16/DES-3/1359 dated the 21112115 vide which application from M/s Maithri Labs Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the expofi of Gemifloxacin Mesylate. This Cepartment has examined the matter and thc follcwing nclrns are furnished under para 4.7 of Hand Bouk oi Procedures ('/oi.i) 2AC9-14:- Under Secretarv to the Governmenl ef India PH:- 2307116'2 2 S.No. lmport ltem 1kq Export Glvcine ethvl ester Hcl 0.967kq 2 DiBOC(Di tert―butvl dicarbonate) 2 408kq 3 Methoxvl amine Hcl 0.404kq 4 2, 6-d ich loro-S-fluo ron icoti non itrile 0.B34kq 5 Cvclopropyl amine 0.261ks

4o /` F. No.3501 1 /67 1 t2015-pl (Norms) Government of lndia Shastri Bhawan,New Delhi, Dated:May 3,2016 0ffice Memorandum Sub:― Fixation of norrns against application of M/s virchOw BiOtech Pvt Ltd,Hyderabad, for Today COntraceptive Sponge. The undersigned is directed lo refe「tO DGFtt U.〇.No. 01/82/050/00861/Aル1- 16/DES-3/905 dated 08/09/2015 on the above mention subiect.The matter has been 以ammed and制o面ng n∝ 7sttettmも hed against hもap酬∽百OR S.No. (1) Description of inputs __(4 Quantity worked out per unit (3) NOnOXynO1 9 0.9983 gm 2 SOrbic Acid 000610m 3 PrePol HDい/-2002 2.40300m 4. Sodium metabisulfite Granular 0.0015 gm 5. tqdlum hydroxide NF 0.0015 gm 6. Benzoic acid USP 0.00310m 7. Cttric acid USP 0()141 gm 8. Tape Removal 0.2457 yards 9. Anchoring Scrim 0.0864 yards 10. Mould Cups Bottom 0.0039 Nos. Mould Cups Top 0.0039 Nos. 12. Pouch― Tpp Web 0.0233 vards 13. Pouch- Bottom Web 0.0233 yards 14 丁DI lndicators 0.0769 per thousand units 2. lt may be pointed out that the applicant has submitted a copy of Test License on Form 29 form State Drug Controller for manufacture of Drugs for Purpose of examination, Test or Analysis. This license was valid till March 2015 only. Accordingly, the DGFT may like ensure avaitability of varid Drug license for commercial production of the export product. 3) This issues with the approval of Director (Policy). Phone: 23071162 Uspi3-Pharma@nic.in (Shtt M∨Singh,FTDO), Udyog Bhawan,New Delhi. i- ".j : | ,.1 :: 多 ル 〆

ヘ No.46011/22/2008‐ PC.II Government ofindia Ministry ofChemicals&Fertilizers Dcpartillent ofChemicals&Pctrochemicals Room No.223,A Wing, Shastri Bhawan,New Delhi‐ 110001 Dated thc 5th April,2016 OFFICE MBMORANDUM Sub: Application from M/s. Pregna International Ltd. for the import of raw material a[ainst the export of Intra Uterine Contraceptive - Copper T 380 A for issue of advance licence (DGITT Ref. No. 01/821050/01l4?,lM-finEs-lll/tz40 dated 10.12.2015) - reg The undersigned is directe,l to ref'er to DGFT U.O. No. 0l/82/050/01142/M-16/DES- lll/1240 dated 10.12.2015 forrvarcled an application tbr issue of advance licence from M/s' pregna International Ltd. fbr thc import oi'r"t" material against the export of lntra, Utgtne Coritraceptive - Copper T 380 A foi issue of advance licence (Licence No' NOT CIVEN)' The application has'been examined in Department of Chernicals and Petrochemicals and the follorving llorms are recommendecl lbr the reference licence application:- This has approval of the competent authority' Joint industrial AdvisCr Tel:011‐23071442 TclethX:011‐ 23071187 Emall:onlshanllaのnt.in Shri Mahender Vikaram Singh, Foreign Trade Development Oftlcer' Direciorate General of froreign Trade. Department of Com merce, Ministry of Commerce and lndustrY, tJclyog Bharvan, New Delhi Fax: 2306 2225 123061613 Name{f Export ltem(s) | QtV lNos. rntra uGtine c""t""."ptill N; CopperT3S0A i Name of import ltem(s) Qty. in kg Coppet wire rvith (99.99% purit"v) 0.000204 Cranules ( rnoulding grade) 0.0012 Pouches (plastics) Net+10% Copper Tubc(99,99%puri塑 o.000169 Polvnroovlene Granules 0,0015543 eom'poa- -of I-PPP resin & barium sulphate 0.000415 PVC 0.000658 HDPE Granuics(Or lly10n rcsin) medical grttC o.000177

-q F Nn 3501 17571201$-Pl /trlo;;Ps) Government of lndia Dated: 2, MaY 2016 Office Memorandum

subject: - Fixation of norms under para 4.7 of Hand Book of procedures (Vol.l) 2009-14

Case of M/s Sriam Labs Pvt' Ltd' The undersigned is directed to refer to DGFT U'O'No' 01182150fi20214M- 16/DES_3/ 127g dared the 16t12r15 vide which application from M/s Sriam Labs Pvt. Ltd. was sent to this Olp"rtrunt for fixation of norms under para: 4 7 fo.r the export of g5so6vir Sulfate. Ti'ris ctepa'tment has examineC the nnatter and the following norms are furnislre<l unCer p^r^ o.:i t f Hapd Book of Procedures (Vot'ri 2009-14'- 2 Thisissueswiththeapprovalofcompetentauthority. PH:- 23071 iC2 lmport ltem 1 042k9 N{2-am lno-4,6-d ich loropyrimid i ne-5- rmamide(FADC 1.39k9 ¬_methanol E)(― rtarate salt Triethylorthoformate

F. No.350 1 1 17441201 s-Pl (Norms) Government of lndia 判 Dated: 3, May 2016 Office Memorandum 14 Case of M/s Rusan Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182150/1159/AM- 16/DES-3/1298 dated the 16112115 vide which application from M/s Rusan Pharma Naltrexone Hcl USP/EP/BP. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14.- 2 (Ralkumar) Under Secretary to the(3overnment oflndia PH:-23071162 / J S No. Export ltem lmport ltem Norms Recommended for 1kq Export 1 Naltrexone Hcl USP/EP/BP Noroxymorphone 1.19kg 2 Naltrexone Base ―do― 1 40kq 3 Nalmefene Hcl ―do― 1.075kq 4 Naloxone Hcl BP/USP/EP ―do― 1 23kg

\ts F. No.3501 117421201s-Pl (Norms) Government of lndia Dated: 29, April 2016 Office Memorandum Sublect: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case of M/s Optimus Drugs Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01lB2l50l1235lAM- 16tDES-3t1241 dated the 15112115 vide which application from M/s Optimus Drugs Pvt. Ltd. was sent to this Department for fixation of norms under para: 4 7 for the export of sofosbuvir. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol l) 2009-14:- DGFT is advised to call following details from th firm viz:- '1 . Complete technical details as per appendix-33 for backward integration of propan intermediate. 2. Copy of technical.literature in support of yield envisged above. 3. Past production vis-d-vis actual consumption of imported inputs duly certified by central excise authorities. 2. (Rajkumar) PH- 23071162

F. No.350 1 1 181912015-Pl (Norms) Government of lndia Dated: 5, May 2016 Office Memorandum 14 Case of M/s Kopran Research Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501144514M- 16/DES-3/1504 dated the 12t1t16 vide which application from M/s Kopran Research Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for lhe export of Sterile Ceftriaxone Sodium. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14- 2 (Rajkumar) PH.- 23071162 J S.No. lmport ltem Norms Recommended for 1kq Export 1 Ceftriaxone sodium non-sterile 1 04kq 2 Acetone 1.72kg 3 Packing material Relevant, As per packinq policy

F No 35011/756/2015-PI(Norms) Government oflndia This issues with the approval of competent authority 弊 Dated: 5, MaY 2016 Office Memorandum

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

14 Case of M/s KoPran Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011199/AM- 16/DES-3/1326 dated the 18112t15 vide which application from M/s Kopran Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Pregabalin. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- DGFT is advised to call following detail from the firm viz:-

  1. Norms applied by the firm do not match with the CA certified data on production-consumption justification for above may be furnished '
  2. bomplete technical details as per appendix-33 is not given by the firm same may be furn ished. S. pait production vis-d-vis actual consumption of all imported inputs duly certified by Central Excise Authorities may be furnished. (Ralkumar) PH:-23071162 Directorate General of Fore19n Trade, Depanment Of Commerce, (Shn M∨Singh,FTDO),

F. No.3501 1/7491201s-Pl (Norms) Government of lndia 2. Depanment of CommerCe, (Shn M V Singh,FTDO), レ Dated: 3, MaY 2016 Office Memorandum

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

14 Case of M/s RA ChemPharma Ltd. The undersigned is directed to refer to DGFT U.O.No 01182150112001AM- 16/DES-3/1306 dated the 16112115 vide which application from M/s RA Chempharma Benserazide Hcl. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol l) 2009-14:- DGFT may once again be advised to call from the firm past production vis-a-vis actual consumption of imforted inputs duly certified by Central Excise Authorities. (Ralkumar) Under Secretary to the Government of:ndia PH■23071162

F No.35011/750/2015-PI(Norms) Government oflndia Dated: 3, MaY 2016 Office Memorandum 14 Case of M/s Suven Life Sciences Ltd. The undersigned is directed to refer to DGFT U.O.No. 01lB2l5Ol1242lAM- 16/DES-3/1238 dated the 15t12t15 vide which application from M/s Suven Life Sciences Ltd. was sent to this Department for fixation of norms under para'.4.7 for the export of 3-fluoro-2-(methyl-propoxycarbonyl-amino)-benzoic acid. This department has examined the matter and the following norms are furnished under

para 4.7 of Hand Book of Procedures (Vol.l) 2009-14.-

DGFT is advised to call following detail from the firm viz:-

  1. Complete technical details as per appendix-33 showing mol. M. of input & output items, %yield on molar basis step and complete description of output products of each steP.
  2. Copy of technical literature in support of yields envisaged.
  3. pasi production vis-d-vis actual consumption of imported inputs duly certified by Central Excise Authorities.

(Ralkumar) PH:-23071162 Directorate(3eneral of Foreign ttrade, (Shri M V・Singh,FTDO),

F.No.35011/758/2015¨ PI(Norms) Government oflndia MiniStry of Chemical&Fertilizers Dated: 29, APril 2016 Office Memorandum 14 Case of M/s Salicylates & Chemicals Pvt. Ltd' The undersigned is directed to refer to DGFT U.O.No. 0118215011201/AM- 16/DES-3/121g daied the 15t12t15 vide which application from Mis salicylates & Chemicals Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Chlorophenesin BP. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol'l) 2009-14.- 2 (Ralkumar) PH:… 23071162 Directorate(3eneral of Foreign Trade, Depattment of Commerce, (ShH M∨・Singh,FTDO), udyog Bhawan,New Delhi S.No 1 lmport ltem Norms Recommended for 1kq Export Ethvl acetate 0 033kg 2 Toluene 0.778kg 3 Para chlorophenol Sodium hydroxide 0.83kg 0 30kg 4 5   一 6 Metfanol Not required in the q:ven process Epichlorohydrin 0.83kg

.L F fJo.35O1 1 182.312015-Pl (Norms) Gc'u'ern' ::e; :i of lndia Dated: APril' 2016 Office Memorandum

subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol'l) 2009-14

Case of M/s Hetero Drugs Ltd' The undersigned is directed to refer to DGFT U'O'No' 01t8215011326/AM- 16/DES-3/1so+ oatid the 1sl1l16 vide which application from M/s Hetero Drugs Ltd' wassenttothisDepartmentforfixationofnormsunderpara.4.Tfortheexportof 2,3,4,5-Bis-O-(1- ""-t'ir,lltftylidene)-B-D-fructopyranose' This d.epartment has era,,linec r.,i.r i,,..tier arid the tottowing norra'are furnished under J,tt'a +' ; qr l":;''r" Book of Procedures (Vol'l) 2009-14"- 2 PH.- 23071162 Directorate General of Foreign Trade' UOyog Bhawan, New Delhi t torms Recommended for D(-)Fructose Toluene ● ′ Acetone

・/

(   主 F. No 350 11t775t201s-Pl (Norms) 2 I A Government of lndia .- Dated: 2, MaY 2016 Office Memorandum 14 Case of M/s lndoco Remedies Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182150/1365/AM- 16/DES-3/1506 dated the 12t1t16 vide which application from M/s lndoco Remedies Azelastine Hydrochloride Ophthalmic Solution 0.05%, 6ml Bottle. This department has examined the matter and the following norms are furnished under paru 4'7 of Hand Book of Procedures (Vol.l) 2009-14:- (Rajkumar) PH- 23071162 S.No. lmport ltem Norms Recommended Azelastine Hcl 3.15mg/6ml Bottle 2 Eye Drop Bottle Relevant, As Per packinq policY 3   一 4 Eye Drop Cap Relevant, As Per packinq policy Eye Drop lnsert Relevant, As Per packing policY y 2

グ F. No.3501 118191201s-Pl (Norms) Government of lndia Dated: 5, MaY 2016 Office Memorandum

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

14 Case of M/s Kopran Research Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82150/1358/AM- 16/DES-3/1586 dated the 1511116 vide which application from M/s Kopran Research Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Meropenem for injection (Meropenem Buffered sterile). This department has examined the matter "nd tn" following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- 2 (Raikuma0 PH.- 23071162 J S.No. 1 lmPort ltem Non-Sterile) Norms Recommended for 1 ko Export 0.987k9

θち 承 ヽ F. No.3501 1178212015-Pl (Norms) Government of lndia Dei'rartr nent of Pltarrilaceiiticals Office Memorandum SuttedltyttT:畷 :よ明 :1111亀鶴 f Hand BoOk Of Procedures Ⅳ dり2009-14 vt.Ltd. The undersigned is directed to refer tO DGFT U O No 01/82/50ノ 1292′AM― 鼎P開:鷲笙鷺淑:1北Ъ皐 :〔鳳 :ボ i歯麗::β::階脚品署 Y:la::ν l月「 :1曹届「 ::r龍繁 l器漏 :占悧 :∫湧 lS店誓電 i『 has eXattned he materand he ttO面ng Book Of ProcedureS(∨011)2009-14:― T 一― ― ― で=― 2 Dated: 11 APril, 2016 Under Secretary tO the Government oflndia PH:-23071162 Direclorate Certl二1 0f Foreign Trade, Depattment of COmmerce, (Shri M・V・Singh,FTDO), S卜lo l Expori lten'i i t no. capsule 408.Omg 1 ∨性amin E 400 1U capsules(tOCOSOft― 400) ___ DL alpha tocoPheryl acetate 10200m9 2 Vitamin E 1000 lU capsules (viboost) ―do― lmpo威ltem I Nor,s Recommended fol

´

ヘ tr Nn.35C 14,!78112Q4.q-Pl (Norms) Government of lndia 2.Thisissueswiththeapprovalofcompetentauthority. Dated. 26 APril, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (vol'l) 2009-14

CaseofM/sSunPharmaceuticallndustriesLtd. The undersigned is directed to refer to DGFT U'O'No' 0118215011295/AM- 16iDES_3/ 1237 dated the 1st12t15 vide which apprication from M/s sun pharmaceutical lndustries Ltd. was sent to this Department for fixation of norms under para: 4'7 for the eyr.irt of clarithromycln carbomer Granules 43.75o/ol44Yo' This department has exai;,inecl 1re matter ar,,-l tiie foiiowing rrorms are furnished under para 4'7 at rianc Book of Procedures (Vol.l) 2009-14"- DGFT is advised to call following details from the firm viz:-

  1. Copy of valid DML for above export nro!.uct9
  2. Cobv of Master_Batch formula duly certified by Q.C. incharge. Under Secretary to the Government oflndla PH:-23071162 Directorate(bじllela1 0f「0「eign‐ l‐rade, Department of COmmerce, 剛y計駆ス I返P晶‖ |“■ 肝

I F. No.3501 117641201s-Pl (Norms) Government of lndia Dated: 5, MaY 2016 Office Memorandum

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

'14 Case of M/s Fresenious Kabi Oncology Ltd. The undersigned is directed to refer to DGFT U.O.No. 01lB2l50l1272lAM- 16/DES-3/1318 dateO the 16112t15 vide which application from M/s Fresenious Kabi oncology Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export 5f Docetaxel lnjection concentrate 160mg/8m1, 120mg/6m1, 80mg/4ml and 20mg/1m1. This department has examined the matter and the following norms are furniJhed under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- DGFT is advised to call following details from the firm viz:-

  1. Copy of the relevant DML for each export item'
  2. Copil of Master_Batch formula for each export product duly certified by Q.c. incharge.
  3. Consumption coefficient of raw material for 1kg API'
  4. Wastage claimed on API for each formulated product to be exported

(Rajkumar) PH- 23071162 Directorate General of Foreign Trade'

ヽ 1 ζ,311 ' tr l!: a501 1178112015-Pl (Norms) GovertrrTtert of lndia Dated: 26 APril, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14

Case of M/s Sun Pharmaceutical lndustries Ltd' The undersigned is directed to refer to DGFT U.O.No. 0118215011438/AM- 16/DES-3/M07 dal6d the 1111116 vide which application from M/s Sun Pharmaceutical lndustries Ltd. was sent to this Department for fixation of norms under para: 4.7 for the e;-cort of Cta;";thrornycin Carbomer Granules 27.5t28oL- This department has eXantii,cd ii:e maiter and iire follOwin$ flOIriiS ai'e;i!'r''shed rrirOer ila;e t"l ::;i Hancl Book of Procedures (Vol.l) 2009-14:- DGFT is advised to call following details from the firm viz:-

  1. Copy of valid DML for above export product' 2i Co'pi of Master-Batch formula duly certified by Q.C. incharge'

PH- 23071162 D,rectoraie General of Fcr-clgn Trade,

′ 03 /8L ::?4: t3T3+8 r. Government of India Ministry of Chemicals and Fertilizers Departmeni ot Cnemlcafl ano Petrochemicals

subject:- Advance Authorization application from Mls' Fine organic lndia Pvt' Ltd' for the

importofrawmaterialagainsttheexportofMonoglyceride(GMS). (Adva n ce Auth o rizat i o n N o " 3J-0797€89d ated 7J2914+2 Ref:u.o.uo@1rygESJIl1J36dated?s#M the rmport of raw material agarnst the export of M/s. Fine Organic lndia Pvt Ltd for MonoglYceride(GMS)' ttem of E て111T¬ tem oflmpO The apptication has been examined based on the and the Department recommends the foltowing norms application. required information furnished by the firm io, tn* present Advance Authorization Ⅲ… 鰻M鋤 ` 棉 :赫 雨 品まettne , 0.900k9 HPS o 180k9 |____ __‐ 1-_12,I重型■___一一一 ThiS iSSues With the apprOVal of COmpetent authOrity. Addl.¶キ :L£亀令 :lχ倉七 | Tel・NO.011-23381430 orcAPC U O 14010′ 129′2011‐CHい|l dated… …403.2016

` F No 35011/836′ 2015-PI(Norrns) Government of lndia DePartment of Pharmaceuticals UdYog Bhawan, New Delhi, Dated: 28 APril, 2016 Office Memorandum

Subject - Fixation of norms under para 4.7 of Hand Book of procedures (Vol.l) 2009-14

Case of M/s Unimax Labs PvL Ltd' The undersigned is directed to refer to DGFT U'O'No' 0118215011369/AM- 16/DES-311473 dated the 12t1t1a ,io" which application from M/s Unimax Labs Pvt' Ltd. was sent to this Department for fixation of norms under para: 4 7 lor the export of Dexamethasone Sodium Phosphate' This department has examined the matter and the following norms are furrrisf,"u u,G' para 4'7 of Hand Book of P'ocedut"eu {'roi'l) 2009-14:- 2. (RaJkumar) Under Secretary tO the Government oflndia PH:… 23071162 Directorate Genera1 0f 10reign Trade, Department of COmmerce, 器y諒譜l脩出H Norms R3cOmmended fOrlkq Ex lmport ltem Dexamethasone

F. No.350 1 1 18361201 5-Pl (Nornns) Government of lndia Dated: 28 April,2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14

Case of M/s Unimax Labs Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182150113721AM. 16/DES-3/1466 dated the 1211116 vide which application from M/s Unimax Labs Pvt. Betamethasone Dipronionate BP93/IJSP-23. This denartmerrt has exrminec tnc matier and the following norms are furnished uncier para 4.7 of Hand Book oi Procedures (Vol.l) 2009-1 4:- S.No. lmport ltem Norms Recommended for 1kq Export Betamethasone 0.868kq 2 PH:-23071162

イ θ ″ ⌒′フ 叉シ 卜 No 35011/786/201 fi´ PI(Norms) Government oflndia Udyog Bhawan,New Delhi, Dated:1l Ap画|,2016 Office Memorandum

Subject: - Fixation of norms under para 4^7 of Hand Book of Procedures (Vol.l) 2009-14

Case of M/s Caplin Point Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011328/AM- 16/DES-3/1415 dated the 1111116 vide which application from M/s Caplin Point Labs Ltd was sent tc this Department for fixation of norms under para. 4.7 for the export of Linccm;,'cin lnjection 600ing/2m1,2nil vial. This department has examinei the matrer and the following norms are furnished under para 4.7 o'f Hand Book of Procedures (Vol.l) 2009-14.- 2 PH:-23071162 フ` ノ 醐ο ' S.No. lmport ltem Norms Recommended 1 Lincomvcin Hcl 614.754 BOU/1 rllil1lon vial

ヘ F. No.350 11 !7 iC.t2015-Pl (Norrns) Government of lndia Dated: April, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14

Case of M/s Lupin Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011671/AM- 16/DES-3/1827 dated the 1513116 vide which application from M/s Lupin Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Rifampicin BP/USP- This departFiritt has e:ramir:ed the rretter and th= follovuing no:rn: ^re iu;'nishei uniier pata 4.7 ol Hand Book of Procedures (Vol.l) 20u9-i4.- n llL- (Rajkumar) Under Secretary to the Governmei:r1ir,ri;1 2 S.No. lmport ltem 1kq Export Sodium Rra s 0.96kqA/kq 2 Chloroform 0.661ks 3 Acetic acid 0.1 6ks 4 Piperazine anhvdrous 0.12kq 5 Methvlene chloride 0.933kq 6 lsopropvl alcohol 0.51kq 7 Dimethvl formamide 0.75kq 8 Tertiarv butvl amine 0.1 9 Acetone 0.57ks 10 I -amino-4-methvl piperazine 0 16kq b.d ^

じ ‐ A びい ?11η l乱)幹 Date:14th ⅣIarch,2016. To, iroreigri'i'i ade L)eveio p'uicui Oii-r';=r, Section DES - V[ . Office of the Director General of Foreign Trade, Ildyog Bhawan, New Delhi. Sub: Ratification of Advance Authorization No. 0310800771121C3100 Dated 08.12.2015, R. A. File No.03/94l040/00682/AM16. Dear Sii', We ha.re obtained Advance Authorization No. 03 i 0s00771120t,00 Datcd 08.12'2015 from Additionai DGFT, Mumbai. We have sriiTender this advance authorization to Adciitionai DGFT Mumbai (a copy of ack-nov,,lcdge receipt and lctter enciosed for r'eacly ref'erence)'oecause sales orcier has been cancelled. Alsc note we have not import env raw material against this authorization' ICii,lly i-iote that w'e have noi r'e'-i'-:irc lixation of a'ihoc norms against this autirur'iza'ri'.:rr. I riurlr\lltL1 I \rur Encl : as above 94.t(-BJ." q tY / 16 -k witiltan 6-cot'-^ CJ^ Jesons lndustries Ltd. Manufacturer of: Synthetic Adhesives, Vinyl Acetate & Acrylic Emulsions 904,Peninsuta Tower l,Ganpatrao Kadam Marg,Lower Paret(W),Mumbai 400 013.india 節鳴 弘 904,Pe雨nsda"werl,Ganparao KaCam Ma嘔 ,LOWer r引ぃwり,Mu‖ υ… VV Vり¨ …

ⅧH1999PL“ 2コ93弔 へ、、送 Tet:(91)(22)66 51 52 53 0 Fax:(91)(22)66 51 52 52 0 emait:info@jesons.net ● CIN No:U24291 1層Jesons Fl www.jesons.net

● | ⌒

63 _ F No 35011/656ノ2015-PI(Norms) Government ofindia Dated.27 April, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14

Case of M/s Blueline Foods (lndia) Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501144714M- 16/DES-3/1404 dated the 711116vide which application from M/s Blueline Foods (lndia) Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of squalene oil 8o%. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- This is another application for squalene oil where both the import and export are B0%. We may inform DGFT as under:-

  1. Both the Export and lmport product are B0% purity.
  2. No Drug Manufacturing Licence is given by the firm to show that export product is a pharmaceutical item. Norms Committee may take a final decision.

PH:-23071162 Directorate General of Foreign ttrade, Depanment Of CommerCe, (Shn M V Singh,FTDO), Udyog Bhawan,New De hi `″ ヽ (Raijku mar)

07 町F ヘ F. No.35011t864t201s-Pl (Norms) 3lT ^ Government of lndia r 「 :″θ 2し,Bの3 Dated: 27 APrll,2016 Office Memorandum 14 Case of M/s Mangalam Drugs & Organics Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182150/1646/AM- 16/DES-3/1762 dat6d the 2t3t16 vide which application from M/s Mangalam Drugs & Organics Ltd. was sent to this Department for fixation of norms under para: 4.7 for lhe ex[ort of Artemether. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14'.- 2 (Ralkumar) Under Secretary to the(3overnment oflndla PH:-23071162 Directorate(3eneral of Foreign Trade, Department of COmmerce, (Sh面MV・Singh,FTDO), Norms Recommended for 1kq Expott S.No. 1 lmport ltem Artemisinin 1.235kg 2 S,ndirrm Rorohvdride 0.188kg 0 50kg 3 Tttmethvl Ortho Acetate ― ~ヽ 、 /ρ

⌒ Government of lndia Ministry of Chemicals and Fertilizers Department of Chemicals and Petrochemicals SubieCt:Advance AuthoHzation application from M/s Navin Fluo百 ne lntemational Pvt.Ltd.,for the import of raw material againstthe export of 2-Fluoro 6 Trifluoro lⅥ ethyl Py「idlne. (Advance Authottzalon No O単解簑Иtt dated¨ M/s. Navin Fluorine lnternational Pvt. Ltd. have submitted present application for the import of raw material against the export of 2- Fluoro 6 Trifluoro Methyl Pyridine. The application has been examined and the Department recommends the following norms for the present Advance Authorization application.

  1. ltem of Export Qty. Item of lmport Qty 2- Fluoro 6 Trifluoro Methyl Pyridine l kg 2 Chloro 6 Trichloro Methyl Pyridine 2.00 kg This issue with the approval of competent authority. 体K Addl.Industrial Advlser Tel.No.011-23381430 ¨ | Deptt.of C&PCUO No. 14010/92/2011‐CH‐ |l dated 8 02.2016. Ret U.〇.No.01/82軍yttЭttM43DES― Ⅲ/3

03/ノθ /γ7~/フ Sル略′3夕′ζ∂写ζげ Government of lndia Ministry of Chemicals and Fertilizers Department of Chemicals and Petrochemicals Subject Advance Authorizatron application from fvl/s. Prasol Chemicals Ltd. for the import of raw material against the export of 3.3,5 TRIMETHYL CYCLOHEXANONE. (Advance AuthonzatOn No g勁0797677蝉2707.201 (Adv a n ce A u t h o ri za t i o gXdn u oz 0 ry$da ate a 24).y. zd1 4) (Advance Author多滞6n No 0319″ 9886 dat"032013) じO No釧朋 ∞ "A耐 留DES― lⅣ9
釧5 M/s. Prasol Chemicals Ltd. have submitted present application for the import of raw material against the export of 3,3,5 TRIMETHYL CYCLOHEXANONE. The application has been examined and the Departmenl recommends the following norms for the present Advance Authorization application. This issue with the approval of competent authority. (AK.AGARWAL) Adイ1.lndt'9・lal AdviSer 7 el :lo Otl‐ ∠。3814oし Shtt Mahendra Vikram.FTDO,(DES― lll)0/o DGFT,Udvoo Bhawan New Delhi-11. Deptt of C&PC U O No 14010/107/2011-CH‐ |l dated 12 01 2016 J 4 ・

  1. ltem of Export Qty Item of lmport Qty 3,3,5 TRIMEttHYL CYCLOHEXANONE l kg 1 lSOPHORON 1 30 kg

ハ Governrnent of lndts Ministry of Chemicals and Fertilizers Departmeni of Chemicals and Petrochemicals 覇‖徹蝋驀懇 :塁鱗鰐:`ポ I段鷹1露翔∬・ 濯Л盤 Ref: UヽO No_01′ 82/050/1289/AM15/DES― lllノ1094 dated 13_1,2015 Mノs NaVin Flourine international PVt_Ltd have subrnitted present applications for the irnport of raw materlai againstthe export Of Z-1.1,1,4,4.4-Hezafluo「 0-2‐ butane(HF0 1336 mzz) 行mギ:種:獅謀 :退鵠驚穐ξ概織晨乱胤犠爾:匙∬罵 ::::駅li:胤1:: こつ 「 ::'ハー 1■■ _ Item of lmPort Qty ltem of ExpOJ 凱 l kg 「 輛1■轟or。_2.2,2輌颯 uo「o ethane FHCFC 123ヽ _ 5 30 kg Z‐ 1.1、1:■,4,4-Hexanuoro― 2‐ butene (HF0 1336 mzz) アヽ■lЪI品帆hブformamtte 14.30 kg This iSSues、″ith the app「OVal of cornpetent authOrity (AK.AGバ象WAL) Addl lnduStrial AdviSer Tel No 011-23381430 Deptt `?62∝ 5

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ハ 働多 Government of lndia Minisiry of Chemicais .r,rrj Fertilizers Department of Chemicals and petrochemicals SublectiAdvance Authorization app:ication frorn M/s Navin Fluo「 ine international Pvt Ltd_fOr the import ofraw mate"al againstthe export Of MEttA AMINO BENZO TRI Rei U.O No 01ノ82ノ050/485ノAM16/DES-1‖ ′466 dated 7 7 2015 M/s Navin Floo「ine internatiOnal P宙 Ltd have subnlilted present applications for the import of raw mateHal againstthe export oF META AMIN0 8ENZO TRI The application have been examrned based on the addition informatron furnish by the ftrm The Department recommends the follovring norms for the present Advance Authonzalron application {Advance Autho百zaton No 0310793856_IFttd,1?妥≧291,)_ ■91た__: i107 KG : 1 ~ ~~ : : 多 ご _ltem Of壺り。載¨______Qt■~二l,電pI「P,二 ^ _ MEttA AMIN0 8=NZ∩ :k3 1 8ENZO TRI FLtJORIDE(BTF) T RIFLUORIDE(MABTF): (Advance Autねorization No 0310791994 dated.1512.2015) 。濃エーII:f指1霞寝票辮農15蔦よ :HYDROFLUORIC ACID i l :40.0/c i , ― ― ‘ 壼 一 一 一 (Advance Autho「ization (Advance Authorizaton i 年9,91三 ^p。 威 I META CHLORO I BENZOTRI FLUORIDE I(MC3TF) This issじes with the approval of cornpetent authority ′ ‐ ・ ‘ 一 一 ‘ 」 ~lf捻取G~1 ^二 | 一″ 一千‰ 一 : No_0310793707 dated 9.2.2015 No_031 0793707 dated_922015) 二Qty 二撻里Fi塾腱L___…………………… :l k9 :BENZO TRIFLUORIDE(BTF) 犠 、ァ (A.KAGARWAL) Addl^lndustrial Adviser Tel.No,011‐ 23381430 shn Mahender Vikram Singh,FTDO,(DES‐ |||)0/o DGFT,Udvoo 8hawan,New Delhi-11. Deptt,of C&PC U.O No.14010/92/2011‐CH―|l dated 20.10.2015

ハ ′

θ Government of lndia Ministry of Chemicals and Fertilizers Oepartmeni of Chemicals and Petrochemicals

subject: Advance Authorization apprication from M/s. Navin Fruorine rnternational Pvt' Ltd', for

the import of raw material against the export of Fluoro Benzene' (Advance Authorization No' 0310793706 dated 09'02'2015) Ref:U.o.No.01/8215ot484tAM-16/DES-lll/388dated07.07.2015 M/s.NavinFluorinelnternationalPvt.Ltd.havesubmittedpresentapplicationforthe import of raw material against the export of Fluoro Benzene' Theapplicationhasbeenexaminedbasedontheadditionalinformationfurnishedbythe firm. rt is indicted by the firm that they are importing Fruoro Benzne in sma' packing of 200 kgs drums and exporting the same "tt", "oopting tne -procedure of distiration and firtration in lso Tanks. The wastage appriert s 2o/o. Department i'ecommends the fo*owing norms for the pr"..nt Advance Authorization application' This issue with the approval of competent authority' lA.K.AGλ RWAL) Addl.industrial AdViSer Tel.No.011‐ 23381430 1.Fluoro Benzene Fluoro Benzene cuo.No. ←022ma

^ F. No.3 50 | | 18621201 5-PI (Norms) Government of India Department of Pharmaceuticals "/ Udyog Bhawan,New Delhi, Dated: 10 MaY, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l)

2009-14 Case of M/s CiPla Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011657lA}.l- 16/DES-3 11763 dated the 213116 vide which application from M/s. Cipla Ltd was sent to this Department for fixation of nonns under para 4.7 fot the export of Abacavir and Lamivudine Tablets. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 - おr Ex f Tablets Re nded Abac Sulfate ′ 'も Aヽ rrirement of AP S Or 0 S.No. Export item Requirement of API for lNo' Tablet Abacavir Sulfate Lan-rivudine 1 Abacavir sulfate & Lamivudine dispersible Tablet 60/30mg Abacavir Sulfate 8L Lamivudine Tablets for Oral Suspension 60/30mg Abamune- L-Baby Tablets 61.2mg 30.6mg つ ´ Abacavir sulfate 600mg +Lamivudine 300mg Tablets 612mg 306mg う D Abacavir Sulttlte 300mg Tablet 306.Omg Nil 4 Abacavir Sulfate dispersible tablet 60rng for Oral Sutp.ntiqn- 61.2nng Nil lmport item (FApCP) Norrns Recommended br lkg I壷円P目監 S.No. 1.042kg 1 3.00kg つ ´

つ D Cyclopropyl Amir-re 0.19kg 4 CAA Hcl 0.675kg 5 Isopropyl Alcohol 1.50kg 6 Triethyl Ortho forrnate 1.375kg 7 methanol 3.00kg Norms Recommended for Lamivudine. S.No. Import item Norins Recolnmended R)r lkR― 1 ( 1' R,2' S,5'R)-menthyl-5 S-(cytosine- 1 " -yl)- 1,3 -oxathiolane-2 R-carboxylate/CME compound 2.19kg つ 乙 Sodium Borohydride 0.48kg ivudi 2. This issues with the approval of competent authority. (Ra Kumar) Under Secretary to the Govemment oflndia PH:-23071162

ヽ3 ^1 -"Y*

tfu '1?T F. No.350 I 1 18621201 5-PI (Norms) Government of India Ministry of Chemical& Fertilizers Dated: l0 MaY,20l6 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s Cipla Ltd.

The undersigned is directed to refer to DGFT U.O.No. 0118215011658/AM-15/DES-3/1764 dated the2l3l16 vide which application from M/s. Cipla Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Tenofovir Disoproxil Fumarate 300mg Tablets etc. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14- [A] Requirement of API's for ExDort of Tablets. S. No. Exoprt ltent Requirement of API for lNo. Tablet Tenofovir Disoproxil Fumarate Emtricitabine Efavirenz Lanllvudine l Tenofbvir Disoproxil Fttntarate 300mg tablet 306mg NIL NIL NIL 0 ん Ienofovir Disoproxil Futttarate 300mg + Emtricitabine 200 mg,tablet 306mg 204m9 NIL NIL Cipla Lamivudine-Lamivudine 300mg+ Ienofbvir Disoproxil Futnarate 300 mg, Iablet 306mg NIL NIL 306mg 4. Efavirenz 600 nrg + Emtricitabine 200mg

  • Tenofovir Disoproxil Fumarate 300 mg, tablet 306mg 204m9 6l2mg NIL Efavirenz 600mg+ Tenofbvir Disoproxi I Fumarate 300 mg+ Emtricitabine 200 mg, tablet 306mg 204m9 612mg NIL

Ienofovir Disoproxil Fttmarate 300 mg + Lanrivudine 300 mg + Efhvirenz 600 mg Iablet 306mg NIL 6l2mg 306me IBl Norms Recommended for Tenofovir Disoproxil Fumarate S. No. Inrport ltern Nonns Recommended for lkg ffi'rt l )-[2-(Phosphonyl Methoxy) Propyl] Adenine (PMPA) 0.769kg つ ‘ Shlorornethyl Isopropyl Carbonate 1.3527k9 J. N-Methyl- 2-Pyrrol idone 1.4878kg 4 Fumaric Acid 0.260kg

Methvlene Dichloride Isopropyl Acetate S No. lmport ltem Norms Reconlmendcd for lkg E調質頭 1 '2R,5R)-5-(4-am ino-5-fl uoro-2-oxo-2H-Pyrimidin- I -yl)-[ 1,3] :xathiolane-2-carboxylic acid, 2S-isopropyl-5R-Methyl-l R- ;yclohexyl ester (FCME Cornpound) 2.50kg う ん Sodiurn Borohydride 0.51k3 Dipotassium Hydrogen PhosPhate 2.075kg ICl Norms Recommended for Emtricitabine. This issues with the approval of cornpetent authority. Directorate General of Foreign Tracie, Depar-tment of Commerce, (Rai Kumar) Under Secretary to the(3overnment ofindia PH.23071162 lDl Norms Recommended for Lirrtrivudine. S.No lmport ltem Norms Recommended for lkg hc l 11'R,2'S,5'R)― Menthyl‐ 5S―(CytOSine-1"¨ YL)-1,3-Oxathiolane― 2R‐ Carboxylatc/CME Conlpound 2 19kg つ 4 Sodiurn Borohydride 0.48kg Dipotassium Hydrogen PhosPhate 1.9849kg 4 Salicylic Acid 0 832kg 5 Irietlrvlarnine 0 575kg 6. Ethyl Acetate I .795lig IEI Norms Recommended for Eね宙renz. S No lmport ltent \lorms Recommended for lkg E@ 1 (S)-S-Ct.,toro-alpha-(Cyc lopropylethyny l)-2-Amino-alpha- lTrifl ugromethyl)Benzene rnethanol 0.987kg う ん n-Heptane 3 653kg

⌒ 夕 して 「 "ン F. No.350 1 1 18361201 5-Pl (Norms) Government of lndia Dated: 28 APril, 2016 Office Memorandum

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

14 Case of M/s Unimax Labs Pvt. Ltd' The undersigned is directed to refer to DGFT U.O.No. 01182150113721AM- 16/DES-3/1466 dated the 12t1t16 vide which application from M/s Unimax Labs Pvt' Betamethasone oipropionate BP93/USP-23. This department has. examined the matter and the following norms are furnished under para 41 of Hand Book of Procedures (Vol. l) 2009-1 4:- 2. Thisissueswiththeapprovalofcompetentauthority. (Rajkumar) PH'.- 23071162 (Shri M.V. Singh, FTDO)' Betamethasone ヽ

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F. No.350 1 1 1557 1201 s-Pl (Norms) Government of lndia Dated: 12 Aprtl,2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14

Case of M/s Metrochem API Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011455/AM- 16/DES-3/1g03 dated the 1st3t16 vide which application from M/s Metrochem API Pvt. Omeprazole. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2O09-14:- 2. PH.- 23071162 S.No. lmport ltem 1kq Expoft 3,5 Lutidine 1.12k9 2 Methvlene chloride 5.95k9 3 Methanol 3.90k9 4 Toluene 4.49kg 5 Actic acid 1.53k9 6 Acetone 1.80k9 7 Ammonium PersulPhate 1.71k9

ダ タ フ g マ ィ ハ F. l.!o.350 4, i !5i7 !2015-f l llJorms) Government of lndia Udyog Bhawan,New Delhi, Dated:12 Ap百1,2016 0ffice Memorandum SubieCt:― Fi×ation of norms under para 4.7 of Hand Book of Procedures(∨ol l)2009-14 Case of M′ s Metrochem API Pvt.Ltd. The undersigned is directed to refer to DGFT U O.No.01/82/50/1456/AN4- 16/DES-3/1804 dated the 15/3/16 vide which application from N1/s卜 Лetrochem API Pvt Ltd was sent to this Department for fixation of norrns under para:4.7 for the export of Omopra=ole pelhts 8.5% T輛s lel)artnnerltt has eva1lo'Oed the rrlatter nn´ thO fol:ザYヽ■,0 「iOli∩S arC fじ「:lisllec uildel pala 4.7 of Hand Book ofF)「 cceduleじ (iv'ol・り2しじじ-14:― 2. l 蕊→ PH:-23071162 S No Import ltem 1kq Export 3,5 Lutidine 0.0961 5kg 2 MethVlene chloride 0 5108kg 3 Methanol 0 3348kg 4 Toluene 0.3846kg 5 Actic acid 0 1300kg 6 Acetone 0 1545kg 7 Ammonium persulphate 0 14535kg 8 Hvdroxy propyl methyl cellusose (HPN/q-Eq 0.04456kg ノ

へ ヘ

⌒ ⌒ F No 35011/861/2015¨ PI(Norms) Government oflndia Department of PharrYlaCeuticals Dated: 10 MaY, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009'14

Case of M/s CiPla Ltd. The undersigned is directed to refer to DGFT U.O'No. 0118215011656/AM- 16/DES-3/1810 dated the 1513116 vide which application from M/s Cipla Ltd' was sent to this Department for fixation of norms under para: 4.7 for the export of Entecavir Monohydrate. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol'l) 2009-14:' 2. Thisissueswiththeapprovalofcompetentauthority. (Ralkumar) PH:-23071162 lmport item rt S.No. 1 90kg DibenzyloXy Guanlne(2-anヽino-1,9-d:hydro― 9(lS,3R,4S)-4-(benZy10Xy)-3¨ (benZyloXymethyl)-2- rnolh、′ lon∩nvclonenivlヽ-6H¨ourin…6-one J

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F No 35011/861ノ2015-PI(No「ms) Government oflndia Department of Pharmaceulcals Dated: 10 MaY,2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol'l) 2009-14

Case of M/s CiPla Ltd. The undersigned is directed to refer to DGFT U'ONo 01/82150/1600/AM- 16/DES-3/1751 dated the 2t3t16 vide which application from Mis cipla Ltd was. sent to tnisOepartr"ntforfixationofnormsunderpara:4'TfortheexportofVetpro- ooY",f Obg. pack and ,"tpto-zo"U",toogm pack' This department has examined the matter and the following 'norms are t-urnisfreO under para 4 7 of Hand Book of Procedures (Vol.l) 2009-1 4:- 2 (Ralkumar) Under Secretary tO the CoVernment oflndia PHl-23071162 Depanment of COmmerce, 器y計譜|口馳h

F No 35011/861ノ2015-PI(Norms) Government oflndia Dated: 10 MaY,2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (vol.l) 2009-14

Case of M/s CiPla Ltd' TheundersignedisdirectedtorefertoDGFTU.o.No.0ll92l'0ll6ollAM- 161DES-311752 dat6d tfre 2t3116 uide which application from Mis Cipla Ltd was sent to tr,i. o"partr"nt for fixation of norms under paia: 4.7 for the export of Fluorometholone o.r"z" wrv ophthalmic Suspension (Eye/Ear Drops), Sml Pack Size. This department has examined the matter and the following norms are furnished under para 4 7 of Hand Book of Procedures (Vol.l) 2009-14:- う 4 This issues with the approval of competent authority (Ralkumar) PH:-23071162 Department of COmmerce, 剛:y計鼎:RI判ヽh / Fluorometholone USP ⌒ ⌒ Norms Recommend璽__ S No に 1

⌒ ^ ′ ノ イ .l 端 ) ア 1 F. No. 350 1 1 1861 1201 s-Pl (Norms) Government of lndia Dated: 10 MaY, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14

Case of M/s CiPla Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011654/AM- 16/DES-3/1802 datJd the 15t3t16 vide which application from M/s Cipla Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Nevirapine Hemihydrate. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14"- (Ralkumar) PH:-23071162 (Shtt M・V・Singh,FTDO), udyog Bhawan,New Delhi 2. 1.375kg 3-(2-chloro-3-pyrid i ne carbonyl)-am i no-2-chloro-4- Calcium oxide Sodiurn hydride S.No. 1. lmport item 2. Cvclopropylamine 0 57kg 3 Diqlvme 2 16kg 4 0.2857kg 5 0.44kg 6 Ethvl acetate 1.70kg

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ヘ F. No.3 50 I 1 18621201 5-PI (Norms) Government of India Udyog Bhawan,New Delhi, Dated: 10 MaY, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l)

2009-14 Case of M/s CiPla Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011655/AM- l61DES-3 ll762 dated the 213116 vide which application from M/s. Cipla Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Exemestane. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (vol.l) 2009-14:- So No. 1. 2. Irnport Item Norms Recommended fbr lkg of Export Androstenedione 2.38kg Dichloro Dicyano Benzoquinone (DDQ) 1.70kg 2. (Ra Kumar) Under Secretary to the Govenllnent oflndia PH:-23071162 」

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^ ri> f "rtn'rT ei N;:tf r- No.3501 1t823t2015-Pl (Norms) ,-/ Gorrernrnent of lnCia UdYog B:,i:'" HHl ???t TheundersignedisdirectedtorefertoDGFTU.o.No.oltSzt1jll45llAM- .16/DES_3/. 807 d#;'il" is[)ro rii" r,i.r, apprication from M/s Hetero Labs Ltd' was serrt tcr tlris Departrunt for fixation oino." under para: 4'7 for the exporl of 4-amino- N_(2R,3S)(3-amino-'i-r.'VJrov-a-pr',"nvr-butyl)-N-isobutylbbtrzene sulfrnamii-' Tiris depaftment has exarnined the q+:fliil".l"]';-ins norms are furnished under Office Memorandum

subject: - Fixation of norms under para 4'7 of Hand Book of Procedures (Vol'l) 2009-14

--.-) Case of M/s Hetero Labs Ltd' 古」こ17聯 LttJ百 ふ島員d PЮ ceduЮ S Ⅳd⇒20094牛 Mrms Recommended for lk Under Secretary tO the(3oVernment oflndia PHl-23071162 2. DirectOrate Genera1 0f Fore19n Trade, W∬鰭朧il J lmpttrt ltem o91k9 amino)-1 '2-ePoxY- 4-phenvl butane isobutyl aqlne Methanol 雷 ヨ ョ ロ ロ ー ロ alcohol

ロ ′ R日::` グ / 5' / イ ) F. No.350 1 1 1861 12015-Pl (Norms) Government of lndia Dated: 10 MaY, 2016 Office Memorandum

subject: - Fixation of norms under para 4.7 of Hand Book of procedures (vol.l) 2009-14

Case of M/s CiPla Ltd. TheundersignedisdirectedtorefertoDGFTU.o.No.0lls2l,0ll6T5lAM- 16/DES-3/ 1757 dated the 213t16 vide which application from M/s cipla Ltd' was sent to this Department for fixation of norms under p"ir, 4-7 for the export of Nevimune 200m9 Tablets/Nevirapine 200mg Tablets and Nevirapine oral suspension 50mg/5ml Nevimune. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol'l) 2009-14:- No‐ ― ゞ \fI. (s- '-1j*'-lr. V<-u( -Jwil

2.Thisissueswiththeapprovalofcompetentauthority. (Raikumar) under secretary to the Governmerisillt; asfii M.V. Singh, FTDO)' Udyog Bhawan, New Delhi Norms Recommended S.No. ZU.Omgt20Omg Tablet And 1020.0m9i 100nq|EPIIIq lkq膿評痒 ‐k感貿月午ルく 1.375k9 @bonyl)-amino-2-ch loro-4- methvl pyridine/(NVP(l l)compound) CvcloproPYlamine Di 0.2857k Calcium oxide Sodium hydride Ethvl acetate

lヽ Dated: 10 MaY,2016 Office Memorandum

subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (vol.l) 2009-14

Case of M/s CiPla Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1660/AM- 16/DES-3/1 809 dateA tne 15t3t16 vide which application from M/s Cipla Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Budesonide lnhalation Suspension 0.25mg/0.50mg/1.Omg per 2ml pack. This department has examined the matter and the f5llowing norms are furnished under para 4 -7 of Hand Book of Procedures (Vol.l) 2009-14:- 2 (Ralkumar) under Secretary to the Government oflndia PH1 23071162 Depa■ment of COmmerce, (shn M v singh,FttDO), f.lornrs Recommended for'1 no. Pack Budesonide USP Net+5°/O N/Vastage (As Per Packinq Poli Net+50/o VVastage (As Per Net+5% llVastage (As Per Packing Pure‖ PE 1840H Granules ン ′ F No 35011/861ノ2015-P!(Norms) Government oflndia Mlnistry of Chemical&Fertilizers S No lmport item 0 25mq/2ml 0 50mg/2ml 1 0nnq/2rni 1 0 2625mg 0 525mg 1 05mq う 4

ヽ 9いし F. No.3501 1/86 1 12015-Pl (Norms) Government of lndia Depariment of Pharmaceuticals a{1 Dated: 10 MaY,2016 Office Memorandum

subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14

Case of M/s CiPla Ltd. TheundersignedisdirectedtorefertoDGFTU.o.No.0llB2lS0ll6T4lAM- .16/DES-3/1755 OateO tre 2/3/16 vide which application from M/s Cipla Ltd. was sentto ttli. o"p"rtr"nt for fixation of norms under'para: 4.7 for the export of Budesonide int "i"tion suspension 0.25mg/0.50mg/1.0mg per 2ml pack. This department has e*umin"O the matter and the f[llowing -norms aie furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- 2 (Raikuma0 PH.- 23071162 (Shri M.V. Singh, FTDO)' Norrns Recommended for 1 no. Pack 1..|gt+5% Wastage (As Per 1',ls{+5% Wastage (As Per Packinq Po Net+5% Wastage (As Per Packing Pure‖ PE 1840H Granules

F. No.350 11 17 461201 5-Pl (Norms) Government of lndia Dated: 7 March, 2016 Office Memorandum 14 Case of M/s Granules lndia Ltd. The undersigned is directed to refer to DGFT U.O.No.0'1 18215011250/AM- 16/DES-3/1365 daied the 21t12t15 vide which application from M/s Granules lndia 1-(2,4-daluoro phenyli-2-(1H-1 ,2,4-triazole-1-yl) ethanone (Ethanone Derivate). This department has examined the matter and the following norms are furnished under

para 4.7 of Hand Book of Procedures (Vol.l) 2009-14'.-

(Rajkumar) PH- 23071162 」 S.No. lmport ltem Norms Recommended for 1kq Export 1,3-difluoro benzene 0.60ks 2 4-am ino- 1,2,4-triazole 0.47ks 3 Methylene chloride 1.41ks

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