DGFT Committee Minutes

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

Para 4.7 Decision

Meeting No. 15/82/2016 of 2016-17 dated 15.12.2016 to consider the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products and falling under Chapter 29 and 30, scheduled to be held on 15.12.2016 but actually held on 29.12.2016 under the Chairmanship of Shri J.V. Patil, Addl. DGFT in Room No.04, Udyog Bhawan, New Delhi. Following members were present:- Shri Nirmal Kumar, Dy. Director General of Foreign Trade Shri V.K. Tyagi, Consultant, D/o Pharmaceuticals. The committee went through the minutes of earlier meeting No. 14/82 dated 29.11.2016 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 : 15/82-ALC4/2016 MEETING DATE : 15.12.2016 1

Case No.:67/23/83-

ALC1/2012 Party Name:STERICON PHARMA PVT.LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/83/050/00467/AM13/ RLA File :07/24/040/00154/AM13/ Lic.No/Date:0710089457 04.07.2012 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/267/2013-PI(Norms) dated 24.06.2013, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 2

Case No.:3/15/82-

ALC4/2016 Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved

2 HQ File :01/82/050/00817/AM17/ RLA File :05/23/040/00119/AM14/ Lic.No/Date:0510358717 04.07.2013 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision of NC in its meeting No.06/82 dated 10.05.2011, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 3

Case No.:24/15/82-

ALC4/2013 Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00786/AM14/ RLA File :03/94/040/00361/AM14/ Lic.No/Date:0310747725 30.08.2013 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.03/82 dated 08.05.2014, uploaded at the end of these minutes or as applied by the firm decision of NC. 4

Case No.:44/13/82-

ALC4/2016 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00672/AM17/ RLA File :34/24/040/00143/AM14/ Lic.No/Date:3410037962 17.09.2013 Defer Date: meeting No.10/82 dated 12.11.2014, uploaded at the end of these minutes or as applied by the firm decision of NC. 5

Case No.:143/23/82-

ALC4/2013 ALLIED PRODUCTS LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01190/AM14/ RLA File :03/94/040/00776/AM14/ Lic.No/Date:0310761498 11.12.2013 Defer Date: meeting No.03/82 dated 08.05.2014, uploaded at the end of these minutes or as applied by the firm decision of NC. 6

Case No.:30/7/82-

ALC4/2016 Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00204/AM17/ RLA File :22/24/040/00069/AM14/ Lic.No/Date:2210014463 20.12.2013 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/128/2016-PI(Norms) dated 15.12.2016, uploaded 7

Case No.:37/6/82-

ALC4/2014 Party Name:IPCA LABORATORIES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00439/AM15/ RLA File :03/94/040/01109/AM14/ Lic.No/Date:0310775194 20.03.2014 Defer Date:

3 meeting No.14/82 dated 22.12.2014, uploaded at the end of these minutes or as applied by the firm decision of NC. 8

Case No.:52/6/82-

ALC4/2014 Party Name:UPL LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 9

Case No.:25/1/82-

ALC1/2016 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01799/AM16/ RLA File :09/24/040/00001/AM15/ Lic.No/Date:0910059732 08.04.2014 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.23/82 dated 06.03.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 10

Case No.:88/6/82-

ALC4/2014 Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 11

Case No.:61/4/82-

ALC4/2014 Party Name:V & V PHARMA INDUSTRIES Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 12

Case No.:73/9/82-

ALC4/2014 Party Name:D. R. COATS INK & RESINS PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 13

Case No.:79/9/82-

ALC4/2014 Party Name:METROPOLITAN EXIMCHEM LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00876/AM15/ RLA File :03/95/040/00337/AM15/ Lic.No/Date:0310787073 18.07.2014 Defer Date: 24.01.2017 Decision :Deferred. 14 Case No.:396/5/82- Party Name:ESTEEM Meet No/Date:15/82- Status:Deferred

4 ALC4/2015 INDUSTRIES PVT. LTD, ALC4/2016 15.12.2016 HQ File :01/82/050/00536/AM16/ RLA File :17/24/040/00047/AM15/ Lic.No/Date:1710005887 24.07.2014 Defer Date: 24.01.2017 Decision :Deferred. 15

Case No.:63/8/82-

ALC4/2014 Party Name:ADCOCK INGRAM LTD, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00727/AM15/ RLA File :07/24/040/00148/AM15/ Lic.No/Date:0710106181 25.07.2014 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/459/2012-PI(Norms) dated 31.10.2012, uploaded 16

Case No.:32/9/82-

ALC4/2014 Party Name:CHEMCON SPECIALITY CHEMICALS P LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 17

Case No.:8/6/82-

ALC4/2014 Party Name:V & V PHARMA INDUSTRIES Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 18

Case No.:31/9/82-

ALC4/2014 Party Name:AMBERNATH ORGANICS PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 19

Case No.:27/9/82-

ALC4/2014 Party Name:GRANULES INDIA LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00824/AM15/ RLA File :09/24/040/00217/AM15/ Lic.No/Date:0910060816 06.08.2014 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/591/2014-PI(Norms) dated 16.03.2015, uploaded 20

Case No.:2/14/82-

ALC4/2015 Party Name:SHREE SHIVSHANKAR DRUGS & PHARMACEUTICALS P. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred

5 HQ File :01/82/050/01138/AM16/ RLA File :03/95/040/00425/AM15/ Lic.No/Date:0310788055 14.08.2014 Defer Date: 24.01.2017 Decision :Deferred for want of comments from DoP. 21

Case No.:215/13/82-

ALC4/2014 Party Name:GOLD STAR CHEMICALS PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 22

Case No.:115/13/82-

ALC4/2016 Party Name:MANGALAM DRUGS & ORGANICS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00743/AM17/ RLA File :03/95/040/00419/AM15/ Lic.No/Date:0310788371 26.08.2014 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/864/2015-PI(Norms) dated 27.04.2016, uploaded 23

Case No.:377/5/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision : Information called for from the firm in NC meeting No.05/82 dated 08.06.2016 is awaited. 24

Case No.:224/13/82-

ALC4/2014 Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 25

Case No.:225/13/82-

ALC4/2014 Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 26

Case No.:262/13/82-

ALC4/2014 Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred.

6 27

Case No.:223/13/82-

ALC4/2014 Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/01226/AM15/ RLA File :03/94/040/00508/AM15/ Lic.No/Date:0310788647 02.09.2014 Defer Date: 24.01.2017 Decision :Deferred. 28

Case No.:3/7/82-

ALC4/2014 Party Name:S V CHEM INTERMEDIATES P LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 29

Case No.:400/5/82-

ALC4/2015 Party Name:YASH RASAYAN & CHEMICALS Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 30

Case No.:12/15/82-

ALC4/2014 Party Name:JINDAL DRUGS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 31

Case No.:15/13/82-

ALC4/2014 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01018/AM15/ RLA File :34/24/040/00161/AM15/ Lic.No/Date:3410040594 30.09.2014 Defer Date: Decision :The Committee decided to ratify norms based on earlier decision taken by NC in its meeting No.26/82 dated 27.09.2011, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per decision of NC. 32

Case No.:19/1/82-

ALC4/2015 Party Name:GEM AROMATICS PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 33

Case No.:29/13/82-

ALC4/2014 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred.

7 34

Case No.:124/13/82-

ALC4/2014 Party Name:PANACEA BIOTEC LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision : The Committee noted that information called for from the firm by NC in its meeting No.03/82 dated 12.05.2016 is awaited. The Committee accordingly decided to await the reply from the firm and deferred the case. 35

Case No.:198/5/82-

ALC4/2015 Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision : The Committee noted that information has been called for from the firm in NC meeting No.07/82 dated 07.07.2016 is awaited. The Committee decided to await the reply and deferred the case. 36

Case No.:25/18/82-

ALC4/2014 Party Name:S.M. CHEMICALS Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/01391/AM15/ RLA File :03/95/040/00580/AM15/ Lic.No/Date:0310791081 14.11.2014 Defer Date: 24.01.2017 Decision :Deferred. 37

Case No.:126/8/82-

ALC4/2015 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 38

Case No.:43/18/82-

ALC4/2014 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01409/AM15/ RLA File :03/95/040/00701/AM15/ Lic.No/Date:0310791419 26.11.2014 Defer Date: meeting No.18/82 dated 19.12.2013, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 39

Case No.:145/5/82-

ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 40 Case No.:127/5/82- ALC4/2015 Party Name:EMAMI LIMITED, Meet No/Date:15/82- ALC4/2016 Status:Deferred

8 15.12.2016 HQ File :01/82/050/00267/AM16/ RLA File :02/24/040/00183/AM15/ Lic.No/Date:0210205355 18.12.2014 Defer Date: 24.01.2017 Decision :Deferred. 41

Case No.:221/5/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 42

Case No.:114/5/82-

ALC4/2015 Party Name:NATIONAL TUBE INDUSTRIES, Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred for comments from MSME. 43

Case No.:218/5/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 44

Case No.:99/18/82-

ALC4/2014 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Approved HQ File :01/82/050/01465/AM15/ RLA File :07/24/040/00302/AM15/ Lic.No/Date:0710107307 30.12.2014 Defer Date: meeting No.03/82 dated 08.05.2014, uploaded at the end of these minutes or as applied by the firm decision of NC. 45

Case No.:111/18/82-

ALC4/2014 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01477/AM15/ RLA File :07/24/040/00307/AM15/ Lic.No/Date:0710107306 30.12.2014 Defer Date: meeting No.08/82 dated 25.09.2014, 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. 46

Case No.:45/5/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00185/AM16/ RLA File :09/24/040/00558/AM15/ Lic.No/Date:0910061483 05.01.2015 Defer Date: 24.01.2017

9 Decision :Deferred. 47

Case No.:102/5/82-

ALC4/2015 Party Name:ALTA LABORATORIES LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 48

Case No.:74/5/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 49

Case No.:149/5/82-

ALC4/2015 Party Name:ALCHEMIE LABORATORIES Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 50

Case No.:219/5/82-

ALC4/2015 Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 51

Case No.:112/5/82-

ALC4/2015 Party Name:UNIMAX CHEMICALS PVT LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00252/AM16/ RLA File :03/95/040/00812/AM15/ Lic.No/Date:0310793039 19.01.2015 Defer Date: 24.01.2017 Decision : The Committee noted that an investigation in the matter is under process. The Committee accordingly, decided to defer the case. 52

Case No.:88/5/82-

ALC4/2015 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision : Deferred for want of comments from AYUSH 53

Case No.:138/8/82-

ALC4/2015 Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File RLA File Lic.No/Date:0310793426 Defer Date:

10 :01/82/050/00934/AM16/ :03/94/040/01099/AM14/ 30.01.2015 24.01.2017 Decision : Information received and sent to DoP for comments. 54

Case No.:275/5/82-

ALC4/2015 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 55

Case No.:285/5/82-

ALC4/2015 ALLIED PRODUCTS LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 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: meeting No.04/82 dated 16.05.2013, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 56

Case No.:279/5/82-

ALC4/2015 Party Name:CROWN CHEMICALS PVT.LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00419/AM16/ RLA File :03/94/040/01088/AM15/ Lic.No/Date:0310793983 19.02.2015 Defer Date: 24.01.2017 Decision :Deferred. 57

Case No.:288/5/82-

ALC4/2015 Party Name:CROWN CHEMICALS PVT.LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision : Deferred. 58

Case No.:335/5/82-

ALC4/2015 Party Name:PRIVI ORGANICS LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 59

Case No.:334/5/82-

ALC4/2015 Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 60 Case No.:309/5/82- ALC4/2015 Party Name:SHREE VALLABH CHEMICAL Meet No/Date:15/82- ALC4/2016 Status:Deferred

11 15.12.2016 HQ File :01/82/050/00449/AM16/ RLA File :08/24/040/00417/AM15/ Lic.No/Date:0810134670 25.02.2015 Defer Date: 24.01.2017 61

Case No.:75/4/82-

ALC4/2015 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00114/AM16/ RLA File :09/24/040/00564/AM15/ Lic.No/Date:0910061653 26.02.2015 Defer Date: 24.01.2017 62

Case No.:273/5/82-

ALC4/2015 Party Name:BHARAT SERUMS & VACCINES LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred for comments from DBT. 63

Case No.:452/5/82-

ALC4/2015 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 64

Case No.:295/5/82-

ALC4/2015 Party Name:PROLIFE INDUSTRIES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 65

Case No.:303/5/82-

ALC4/2015 Party Name:ASSOCIATED DYESTUFF PVT. LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 66

Case No.:300/5/82-

ALC4/2015 Party Name:ADVANCE PETROCHEMICALS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 67

Case No.:447/5/82-

ALC4/2015 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred

12 HQ File :01/82/050/00587/AM16/ RLA File :03/94/040/01131/AM15/ Lic.No/Date:0310794543 12.03.2015 Defer Date: 24.01.2017 Decision : 68

Case No.:291/5/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 69

Case No.:183/5/82-

ALC4/2015 Party Name:SPAK ORGOCHEM (INDIA) PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 70

Case No.:29/5/82-

ALC4/2015 Party Name:ASSOCIATED DYESTUFF PVT. LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 71

Case No.:82/4/82-

ALC4/2015 Party Name:BIOLOGICAL E LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00121/AM16/ RLA File :09/24/040/00663/AM15/ Lic.No/Date:0910061841 31.03.2015 Defer Date: 24.01.2017 72

Case No.:26/5/82-

ALC4/2015 Party Name:CONTINENTAL CHEMICALS Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 73

Case No.:35/5/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 74

Case No.:132/7/82-

ALC4/2015 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File RLA File Lic.No/Date:0310795429 Defer Date:

13 :01/82/050/00737/AM16/ :03/94/040/00024/AM16/ 20.04.2015 24.01.2017 Decision : Information called for from the firm in NC meeting No.07/82 dated 07.07.2016 is awaited. The Committee accordingly deferred the case. 75

Case No.:40/8/82-

ALC4/2015 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 76

Case No.:68/4/82-

ALC4/2015 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00107/AM16/ RLA File :34/24/040/00003/AM16/ Lic.No/Date:3410041183 28.04.2015 Defer Date: meeting No.14/82 dated 24.10.2013, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 77

Case No.:174/5/82-

ALC4/2015 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00314/AM16/ RLA File :07/24/040/00393/AM15/ Lic.No/Date:0710108142 01.05.2015 Defer Date: meeting No.08/82 dated 25.09.2014, 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. 78

Case No.:176/5/82-

ALC4/2015 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Approved HQ File :01/82/050/00316/AM16/ RLA File :07/24/040/00389/AM15/ Lic.No/Date:0710108141 01.05.2015 Defer Date: meeting No.23/82 dated 01.11.2012, uploaded at the end of these minutes or as applied by the firm decision of NC. 79

Case No.:177/5/82-

ALC4/2015 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Approved HQ File :01/82/050/00317/AM16/ RLA File :07/24/040/00390/AM15/ Lic.No/Date:0710108143 01.05.2015 Defer Date: meeting No.08/82 dated 25.09.2014, uploaded at the end of these minutes or as applied by the firm decision of NC. 80 Case No.:75/8/82- Party Name:PORUS Meet No/Date:15/82- Status:Deferred

14 ALC4/2015 LABORATORIES PVT LTD ALC4/2016 15.12.2016 HQ File :01/82/050/00871/AM16/ RLA File :09/24/040/00051/AM16/ Lic.No/Date:0910061986 06.05.2015 Defer Date: 24.01.2017 Decision :Deferred. 81

Case No.:65/8/82-

ALC4/2015 Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00861/AM16/ RLA File :09/24/040/00052/AM16/ Lic.No/Date:0910061973 06.05.2015 Defer Date: 24.01.2017 Decision : The Committee noted that Information has been called for from the firm in NC meeting No.03 dated 12.05.2016 is awaited. The Committee accordingly deferred the case. 82

Case No.:7/5/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision : The Committee noted that Information has been called for from the firm in NC meeting No.03 dated 12.05.2016 is awaited. The Committee accordingly deferred the case. 83

Case No.:97/8/82-

ALC4/2015 Party Name:ASCENT FINECHEM PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 84

Case No.:45/8/82-

ALC4/2015 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision : The Committee noted that Information has been called for from the firm in NC meeting No.20 dated 09.03.2016 is awaited. The Committee accordingly deferred the case. 85

Case No.:86/8/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 86

Case No.:187/7/82-

ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 87

Case No.:24/13/82-

ALC4/2016 Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00652/AM17/ RLA File :09/24/040/00034/AM16/ Lic.No/Date:0910062155 10.06.2015 Defer Date: 24.01.2017 88

Case No.:121/8/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 89

Case No.:89/7/82-

ALC4/2015 Party Name:HALDIA PETROCHEMICALS LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 90

Case No.:97/14/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 91

Case No.:54/8/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00850/AM16/ RLA File :05/23/040/00150/AM16/ Lic.No/Date:0510394862 09.07.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/662/2015-PI(Norms) dated 18.05.2016, uploaded 92

Case No.:50/8/82-

ALC4/2015 Party Name:PUSILIN BIOTECHNOLOGY PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision : Deferred for want of comments from DBT. 93 Case No.:54/14/82- ALC4/2015 Party Name:BIOLOGICAL E Meet No/Date:15/82- ALC4/2016 Status:Deferred

16 LTD 15.12.2016 HQ File :01/82/050/01190/AM16/ RLA File :09/24/040/00524/AM15/ Lic.No/Date:0910062332 15.07.2015 Defer Date: 24.01.2017 meeting No.03 dated 12.05.2016 is awaited. The Committee decided to await the reply and deferred the case. 94

Case No.:59/14/82-

ALC4/2015 Party Name:BIOLOGICAL E LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/01195/AM16/ RLA File :09/24/040/00525/AM15/ Lic.No/Date:0910062331 15.07.2015 Defer Date: 24.01.2017 meeting No.03 dated 12.05.2016 is awaited. The Committee decided to await the reply and deferred the case. 95

Case No.:49/8/82-

ALC4/2015 Party Name:M.L.A. INDUSTRIES Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 96

Case No.:120/8/82-

ALC4/2015 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00916/AM16/ RLA File :03/95/040/00304/AM16/ Lic.No/Date:0310797293 16.07.2015 Defer Date: meeting No.02/82 dated 18.04.2013, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 97

Case No.:49/14/82-

ALC4/2015 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 98

Case No.:39/14/82-

ALC4/2015 Party Name:JAGSONPAL PHARMACEUTICALS LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 meeting No.03 dated 12.05.2016 is awaited. The Committee decided to await the reply and deferred the case. 99 Case No.:38/14/82- Party Name:SUN Meet No/Date:15/82- Status:Deferred

17 ALC4/2015 PHARMACEUTICAL INDUSTRIES LTD., ALC4/2016 15.12.2016 HQ File :01/82/050/01174/AM16/ RLA File :05/24/040/00115/AM16/ Lic.No/Date:0510395018 21.07.2015 Defer Date: 24.01.2017 Decision :Deferred. 100

Case No.:21/16/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 meeting No.05 dated 08.06.2016 is awaited. The Committee decided to await the reply and deferred the case. 101

Case No.:1/10/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00957/AM16/ RLA File :09/24/040/00211/AM16/ Lic.No/Date:0910062393 28.07.2015 Defer Date: 24.01.2017 Decision :Deferred. 102

Case No.:131/14/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 103

Case No.:60/14/82-

ALC4/2015 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 104

Case No.:84/1/82-

ALC1/2016 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 105

Case No.:169/14/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017

18 Decision :Deferred. 106

Case No.:17/8/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 107

Case No.:168/14/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 108

Case No.:18/14/82-

ALC4/2015 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 109

Case No.:115/16/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01435/AM16/ RLA File :03/95/040/00164/AM16/ Lic.No/Date:0310798051 10.08.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/779/2015-PI(Norms) dated 16.12.2016, uploaded 110

Case No.:23/8/82-

ALC4/2015 Party Name:ALPHAMED FORMULATIONS P LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 meeting No.03 dated 12.05.2016 is awaited. The Committee decided to await the reply and deferred the case. 111

Case No.:155/14/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 meeting No.03 dated 12.05.2016 is awaited. The Committee decided to await the reply and deferred the case.

19 112

Case No.:11/18/82-

ALC4/2015 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 113

Case No.:34/14/82-

ALC4/2015 Party Name:TRANSPEK INDUSTRY LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 114

Case No.:99/14/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 meeting No20/82 dated 09.03.2016 is awaited. The Committee decided to await the reply and deferred the case. 115

Case No.:56/13/82-

ALC4/2015 Party Name:PANACEA BIOTEC LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 meeting No03/82 dated 12.05.2016 is awaited. The Committee decided to await the 116

Case No.:154/14/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 117

Case No.:68/14/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 118 Case No.:24/14/82- ALC4/2015 Party Name:SHUBHAM SPECIALTY Meet No/Date:15/82- ALC4/2016 Status:Deferred

20 PRODUCTS 15.12.2016 HQ File :01/82/050/01160/AM16/ RLA File :03/95/040/00348/AM16/ Lic.No/Date:0310798516 27.08.2015 Defer Date: 24.01.2017 Decision :Deferred. 119

Case No.:117/13/82-

ALC4/2016 Party Name:SOFTGEL HEALTH CARE PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00745/AM17/ RLA File :04/24/040/00092/AM16/ Lic.No/Date:0410160962 28.08.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/131/2014-PI(Norms) dated 20.01.2015, uploaded 120

Case No.:82/14/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 121

Case No.:89/14/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 122

Case No.:94/14/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 123

Case No.:116/16/82-

ALC4/2015 Party Name:PANERA BIOTEC PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred for want of comments from DBT. 124

Case No.:93/14/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision : Deferred for want of comments from DoP.

21 125

Case No.:124/7/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00298/AM17/ RLA File :03/94/040/00424/AM16/ Lic.No/Date:0310798671 04.09.2015 Defer Date: 24.01.2017 126

Case No.:59/11/82-

ALC4/2016 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00593/AM17/ RLA File :52/24/040/00040/AM16/ Lic.No/Date:5210041626 04.09.2015 Defer Date: 24.01.2017 Decision :Deferred. 127

Case No.:141/14/82-

ALC4/2015 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01277/AM16/ RLA File :17/24/040/00050/AM16/ Lic.No/Date:1710006170 04.09.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide 14010/78/2012-Ch-II dated 09.03.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 128

Case No.:52/14/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 meeting No.03/82 dated 12.05.2016 is awaited. The Committee decided to await the 129

Case No.:56/14/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 130

Case No.:124/16/82-

ALC4/2015 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01444/AM16/ RLA File :03/94/040/00399/AM16/ Lic.No/Date:0310798771 09.09.2015 Defer Date Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.11/82 dated 19.06.2012, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

22 131

Case No.:46/14/82-

ALC4/2015 Party Name:MALWA OXYGEN & INDUSTRIAL GASES PVT.LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 132

Case No.:53/14/82-

ALC4/2015 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01189/AM16/ RLA File :09/24/040/00315/AM16/ Lic.No/Date:0910062581 09.09.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/811/2015-PI(Norms) dated 07.06.2016, uploaded 133

Case No.:157/14/82-

ALC4/2015 Party Name:AETHER INDUSTRIES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 134

Case No.:9/16/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 meeting No05/82 dated 08.06.2016 is awaited. The Committee decided to await the 135

Case No.:56/16/82-

ALC4/2015 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01376/AM16/ RLA File :03/94/040/00435/AM16/ Lic.No/Date:0310798876 14.09.2015 Defer Date: its meeting No.11/82 dated 19.06.2012, uploaded at the end of these minutes or as applied by 136

Case No.:8/14/82-

ALC4/2015 Party Name:PRIVI ORGANICS LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred.

23 137

Case No.:110/14/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 138

Case No.:134/14/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/01270/AM16/ RLA File :09/24/040/00273/AM16/ Lic.No/Date:0910062602 14.09.2015 Defer Date: 24.01.2017 Decision :Deferred. 139

Case No.:7/14/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: approved HQ File :01/82/050/01143/AM16/ RLA File :03/95/040/00426/AM16/ Lic.No/Date:0310798872 14.09.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/779/2015-PI(Norms) dated 16.12.2016, uploaded 140

Case No.:74/14/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 141

Case No.:15/14/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 142

Case No.:9/14/82-

ALC4/2015 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 143

Case No.:124/14/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File RLA File Lic.No/Date:0910062622 Defer Date:

24 :01/82/050/01260/AM16/ :09/24/040/00355/AM16/ 16.09.2015 24.01.2017 Decision :Deferred. 144

Case No.:35/16/82-

ALC4/2015 Party Name:D. R. COATS INK & RESINS PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 145

Case No.:34/16/82-

ALC4/2015 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/01354/AM16/ RLA File :03/94/040/00472/AM16/ Lic.No/Date:0310798979 21.09.2015 Defer Date: 24.01.2017 meeting No03/82 dated 12.05.2016 is awaited. The Committee decided to await the 146

Case No.:64/21/82-

ALC4/2015 Party Name:CADILA HEALTHCARE LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 147

Case No.:64/14/82-

ALC4/2015 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 meeting No.20/82 dated 09.03.2016 is awaited. The Committee decided to await the 148

Case No.:117/14/82-

ALC4/2015 Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 meeting No.20/82 dated 09.03.2016 is awaited. The Committee decided to await the 149

Case No.:103/14/82-

ALC4/2015 Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017

25 meeting No.03/82 dated 12.05.2016 is awaited. The Committee decided to await the 150

Case No.:25/20/82-

ALC4/2015 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 meeting No.11/82 dated 07.08.2016 is awaited. The Committee decided to await the 151

Case No.:106/14/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 meeting No.07/82 dated 07.07.2016 is awaited. The Committee decided to await the 152

Case No.:91/14/82-

ALC4/2015 Party Name:CURETECH SKINCARE Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 meeting No.07/82 dated 07.07.2016 is awaited. The Committee decided to await the 153

Case No.:86/14/82-

ALC4/2015 Party Name:BELLAPREMIER HAPPY HYGIENECARE PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 meeting No.09/82 dated 10.08.2016 is awaited. The Committee decided to await the 154

Case No.:79/14/82-

ALC4/2015 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 155

Case No.:69/16/82-

ALC4/2015 Party Name:PIDILITE INDUSTRIES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred

26 HQ File :01/82/050/01389/AM16/ RLA File :03/95/040/00350/AM15/ Lic.No/Date:0310799113 30.09.2015 Defer Date: 24.01.2017 Decision :Deferred. 156

Case No.:43/16/82-

ALC4/2015 Party Name:INDOFIL INDUSTRIES LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 157

Case No.:67/16/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01387/AM16/ RLA File :03/95/040/00485/AM16/ Lic.No/Date:0310799241 06.10.2015 Defer Date: Decision : The Committee decided to ratify norms based on the earlier recommendation of D/o CPC forwarded vide U.O.No.14010/95/2011-Ch-II dated 11.09.2015, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 158

Case No.:139/14/82-

ALC4/2015 Party Name:MAMTA POLYCOATS Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 159

Case No.:126/16/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 160

Case No.:61/16/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01381/AM16/ RLA File :03/95/040/00483/AM16/ Lic.No/Date:0310799284 08.10.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/779/2015-PI(Norms) dated 16.12.2016, uploaded 161

Case No.:62/16/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred.

27 162

Case No.:164/14/82-

ALC4/2015 Party Name:AASHA BIOCHEM Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 meeting No.05/82 dated 08.06.2016 is awaited. The Committee decided to await the 163

Case No.:140/14/82-

ALC4/2015 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 164

Case No.:132/14/82-

ALC4/2015 Party Name:RIDDHI PHARMA Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 165

Case No.:116/13/82-

ALC4/2016 Party Name:SOFTGEL HEALTH CARE PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00744/AM17/ RLA File :04/24/040/00143/AM16/ Lic.No/Date:0410161132 20.10.2015 Defer Date: 24.01.2017 166

Case No.:72/16/82-

ALC4/2015 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 167

Case No.:73/16/82-

ALC4/2015 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 168

Case No.:29/16/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File RLA File Lic.No/Date:0910062768 Defer Date:

28 :01/82/050/01349/AM16/ :09/24/040/00379/AM16/ 23.10.2015 24.01.2017 Decision :Deferred. 169

Case No.:30/16/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 170

Case No.:129/16/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 171

Case No.:161/14/82-

ALC4/2015 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 172

Case No.:78/16/82-

ALC4/2015 Party Name:MOHINI ORGANICS PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 173

Case No.:53/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01636/AM16/ RLA File :03/95/040/00529/AM16/ Lic.No/Date:0310799675 26.10.2015 Defer Date: Decision : The Committee decided to ratify norms based on earlier decision taken by NC in its meeting No.12/82 dated 03.07.2012, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 17 4

Case No.:93/16/82-

ALC4/2015 Party Name:JAINEX SPECIALITY CHEMI CAL Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approve d HQ File :01/82/050/01413/AM 16/ RLA File :34/24/040/00196/AM16/ Lic.No/Date:3410041626 28.10.2015 Defer Date: Decision : The Committee decided to ratify norms based on earlier decision taken by NC in its meeting No.06/82 dated 08.05.2012, uploaded at the end of these minutes or as applied by the firm

29 decision of NC. 175

Case No.:31/16/82-

ALC4/2015 Party Name:MSN LABORATORIES PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 meeting No.05/82 dated 08.06.2016 is awaited. The Committee decided to await the 176

Case No.:74/16/82-

ALC4/2015 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 177

Case No.:75/16/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 178

Case No.:47/16/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 179

Case No.:136/14/82-

ALC4/2015 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 meeting No.03/82 dated 12.05.2016 is awaited. The Committee decided to await the 180

Case No.:48/16/82-

ALC4/2015 Party Name:O C SPECIALITIES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 181 Case No.:159/14/82- ALC4/2015 Party Name:SUN PHARMACEUTICAL Meet No/Date:15/82- ALC4/2016 Status:Deferred

30 INDUSTRIES LTD., 15.12.2016 HQ File :01/82/050/01295/AM16/ RLA File :05/24/040/00343/AM16/ Lic.No/Date:0510396075 30.10.2015 Defer Date: 24.01.2017 meeting No.03/82 dated 12.05.2016 is awaited. The Committee decided to await the 182

Case No.:118/16/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 meeting No.03/82 dated 12.05.2016 is awaited. The Committee decided to await the 183

Case No.:84/16/82-

ALC4/2015 Party Name:VENUS REMEDIES LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01404/AM16/ RLA File :22/24/040/00055/AM16/ Lic.No/Date:2210015339 30.10.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/784/2015-PI(Norms) dated 29.04.2016, uploaded 184

Case No.:112/16/82-

ALC4/2015 Party Name:BELCO PHARMA Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 185

Case No.:107/16/82-

ALC4/2015 Party Name:HELLO PAINTS (P) LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 186

Case No.:90/16/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01410/AM16/ RLA File :34/24/040/00207/AM16/ Lic.No/Date:3410041662 05.11.2015 Defer Date: Decision :The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.26/82 dated 27.09.2011, uploaded at the end of these minutes or as applied by the 187 Case No.:88/16/82- Party Name:SHIVA Meet No/Date:15/82- Status:Deferred

31 ALC4/2015 PHARMACHEM LTD, ALC4/2016 15.12.2016 HQ File :01/82/050/01408/AM16/ RLA File :34/24/040/00202/AM16/ Lic.No/Date:3410041663 05.11.2015 Defer Date: 24.01.2017 Decision :Deferred. 188

Case No.:53/16/82-

ALC4/2015 Party Name:LAXMI ORGANIC INDUSTRIES LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 189

Case No.:89/16/82-

ALC4/2015 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 190

Case No.:34/1/82-

ALC1/2016 Party Name:GLAND PHARMA LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Approved HQ File :01/82/050/01808/AM16/ RLA File :09/24/040/00469/AM16/ Lic.No/Date:0910062848 10.11.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/38/2016-PI(Norms) dated 21.11.2016, uploaded 191

Case No.:114/16/82-

ALC4/2015 Party Name:SHIVA BIOCHEM INDUSTRIES Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred 192

Case No.:104/16/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 193

Case No.:4/20/82-

ALC4/2015 Party Name:AIMS IMPEX PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred.

32 194

Case No.:31/1/82-

ALC1/2016 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 195

Case No.:2/20/82-

ALC4/2015 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/01585/AM16/ RLA File :05/24/040/00400/AM16/ Lic.No/Date:0510396400 23.11.2015 Defer Date: 24.01.2017 Decision :Deferred. 196

Case No.:33/1/82-

ALC1/2016 Party Name:INCHEM LABORATORIES PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 197

Case No.:32/16/82-

ALC4/2015 Party Name:INTERMED, Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 198

Case No.:2/1/82-

ALC1/2016 Party Name:UNIJULES LIFE SCIENCES LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 199

Case No.:23/1/82-

ALC1/2016 Party Name:UNILINK PHARMA PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01797/AM16/ RLA File :04/24/040/00170/AM16/ Lic.No/Date:0410161342 26.11.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/36/2016-PI(Norms) dated 18.11.2016, uploaded 200

Case No.:58/20/82-

ALC4/2015 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Copy of application has been sent to MSME for comments.

33 201

Case No.:3/1/82-

ALC1/2016 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision : Copy of application has been sent to MSME for comments. 202

Case No.:5/1/82-

ALC1/2016 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision : Copy of application has been sent to MSME for comments. 203

Case No.:54/20/82-

ALC4/2015 Party Name:MELOG SPECIALITY CHEMICALS PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/01637/AM16/ RLA File :03/95/040/00631/AM16/ Lic.No/Date:0310800619 03.12.2015 Defer Date: 24.01.2017 Decision :Deferred. 204

Case No.:112/20/82-

ALC4/2015 Party Name:SUPREET CHEMICALS PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 205

Case No.:87/20/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision : Copy of application has been sent to MSME for comments. 206

Case No.:127/16/82-

ALC4/2015 Party Name:BLUELINE FOODS (INDIA) PVT.LTD, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/01447/AM16/ RLA File :07/24/040/00267/AM16/ Lic.No/Date:0710109146 08.12.2015 Defer Date: 24.01.2017 Decision :Deferred. 207

Case No.:36/20/82-

ALC4/2015 Party Name:BAYER VAPI PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred.

34 208

Case No.:67/20/82-

ALC4/2015 Party Name:MANGALAM ORGANICS LIMITED (FORMERLY DUJODWALA Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01650/AM16/ RLA File :03/95/040/00054/AM16/ Lic.No/Date:0310800865 10.12.2015 Defer Date: its meeting No.33/82 dated 15.11.2011, uploaded at the end of these minutes or as applied by 209

Case No.:110/20/82-

ALC4/2015 Party Name:PROCESS AGROCHEM INDUSTRIES PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision : Copy of application has been sent to MSME for comments. 210

Case No.:39/20/82-

ALC4/2015 ALLIED PRODUCTS LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01622/AM16/ RLA File :03/94/040/00088/AM16/ Lic.No/Date:0310800889 11.12.2015 Defer Date: its meeting No.04/82 dated 16.05.2013, uploaded at the end of these minutes or as applied by the 211

Case No.:41/20/82-

ALC4/2015 ALLIED PRODUCTS LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01624/AM16/ RLA File :03/94/040/00648/AM16/ Lic.No/Date:0310800905 11.12.2015 Defer Date: its meeting No.04/82 dated 16.05.2013, uploaded at the end of these minutes or as applied by the 212

Case No.:9/1/82-

ALC1/2016 ALLIED PRODUCTS LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01783/AM16/ RLA File :03/94/040/00490/AM16/ Lic.No/Date:0310800912 11.12.2015 Defer Date: its meeting No.03/82 dated 08.05.2014, uploaded at the end of these minutes or as applied by the 213

Case No.:66/20/82-

ALC4/2015 Party Name:PRIVI ORGANICS LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File RLA File Lic.No/Date:0310800935 Defer Date:

35 :01/82/050/01649/AM16/ :03/95/040/00633/AM16/ 11.12.2015 24.01.2017 Decision :Deferred. 214

Case No.:45/20/82-

ALC4/2015 Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 215

Case No.:24/20/82-

ALC4/2015 Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 216

Case No.:49/20/82-

ALC4/2015 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01632/AM16/ RLA File :03/94/040/00714/AM16/ Lic.No/Date:0310801093 16.12.2015 Defer Date: its meeting No.18/82 dated 30.08.2012, uploaded at the end of these minutes or as applied by 217

Case No.:10/1/82-

ALC1/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01784/AM16/ RLA File :03/94/040/00630/AM16/ Lic.No/Date:0310801130 16.12.2015 Defer Date: its meeting No.18/82 dated 19.12.2013, uploaded at the end of these minutes or as applied by 218

Case No.:46/20/82-

ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 219

Case No.:23/20/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision : Copy of application has been sent to MSME for comments.

36 220

Case No.:8/20/82-

ALC4/2015 Party Name:SHREE BANKEY BEHARI LAL BOARD MILLS Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 221

Case No.:8/1/82-

ALC1/2016 ALLIED PRODUCTS LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01782/AM16/ RLA File :03/94/040/00754/AM16/ Lic.No/Date:0310801214 18.12.2015 Defer Date: its meeting No.03/82 dated 08.05.2014, uploaded at the end of these minutes or as applied by the 222

Case No.:83/1/82-

ALC1/2016 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 223

Case No.:14/20/82-

ALC4/2015 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 224

Case No.:19/20/82-

ALC4/2015 Party Name:LAXMI ORGANIC INDUSTRIES LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/01602/AM16/ RLA File :03/95/040/00009/AM16/ Lic.No/Date:0310801275 22.12.2015 Defer Date: 24.01.2017 Decision :Deferred. 225

Case No.:20/20/82-

ALC4/2015 Party Name:LAXMI ORGANIC INDUSTRIES LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 226

Case No.:48/20/82-

ALC4/2015 Party Name:ALCHEMIE LABORATORIES Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017

37 Decision :Deferred. 227

Case No.:80/13/82-

ALC4/2016 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00708/AM17/ RLA File :09/24/040/00509/AM16/ Lic.No/Date:0910063036 28.12.2015 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.08/82 dated 25.09.2014, 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. 228

Case No.:80/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01663/AM16/ RLA File :03/95/040/00736/AM16/ Lic.No/Date:0310801389 29.12.2015 Defer Date: Decision : The Committee decided to ratify norms based on earlier decision taken by NC in its meeting No.22/82 dated 20.02.2014, uploaded at the end of these minutes or as applied by the 229

Case No.:81/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01664/AM16/ RLA File :03/95/040/00735/AM16/ Lic.No/Date:0310801388 29.12.2015 Defer Date: Decision : The Committee decided to ratify norms based on earlier decision taken by NC in its meeting No.22/82 dated 20.02.2014, uploaded at the end of these minutes or as applied by the 230

Case No.:22/20/82-

ALC4/2015 Party Name:S M B CORPORATION OF INDIA Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 231

Case No.:47/20/82-

ALC4/2015 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 232

Case No.:98/20/82-

ALC4/2015 KABI ONCOLOGY LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision : Information called for from the firm in NC meeting No.07/AM17 dated 07.07.2016 is

38 awaited. The committee accordingly deferred the case. 233

Case No.:99/20/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 234

Case No.:101/20/82-

ALC4/2015 Party Name:SONGWON SPECIALTY CHEMICALS INDIA PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/01684/AM16/ RLA File :34/24/040/00226/AM16/ Lic.No/Date:3410041775 31.12.2015 Defer Date: 24.01.2017 Decision :Deferred. 235

Case No.:119/20/82-

ALC4/2015 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :copy of application has been sent to MSME for comments 236

Case No.:104/20/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 237

Case No.:82/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Approved HQ File :01/82/050/01665/AM16/ RLA File :03/95/040/00750/AM16/ Lic.No/Date:0310801522 04.01.2016 Defer Date: Decision : The Committee decided to ratify norms based on earlier decision taken by NC in its meeting No.22/82 dated 20.02.2014, uploaded at the end of these minutes or as applied by the 238

Case No.:83/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01666/AM16/ RLA File :03/95/040/00749/AM16/ Lic.No/Date:0310801521 04.01.2016 Defer Date: Decision : The Committee decided to ratify norms based on earlier decision taken by NC in its meeting No.22/82 dated 20.02.2014, uploaded at the end of these minutes or as applied by the

39 239

Case No.:105/20/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 240

Case No.:78/20/82-

ALC4/2015 Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 241

Case No.:26/20/82-

ALC4/2015 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 242

Case No.:7/1/82-

ALC1/2016 Party Name:PRIVI ORGANICS LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 243

Case No.:76/20/82-

ALC4/2015 Party Name:AIMS IMPEX PVT. LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 244

Case No.:103/20/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 245

Case No.:6/1/82-

ALC1/2016 Party Name:MEDISPRAY LABORATORIES PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision : Information called for from the firm in NC meeting No.11/AM17 dated 07.09.2016 is awaited. The committee accordingly deferred the case.

40 246

Case No.:32/1/82-

ALC1/2016 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 247

Case No.:95/20/82-

ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision : Information called for from the firm in NC meeting No.07/AM17 dated 07.07.2016 is awaited. The committee accordingly deferred the case. 248

Case No.:79/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01662/AM16/ RLA File :03/95/040/00765/AM16/ Lic.No/Date:0310801655 08.01.2016 Defer Date: Decision : The Committee decided to ratify norms based on earlier decision taken by NC in its meeting No.01/82 dated 04.04.2013, uploaded at the end of these minutes or as applied by the 249

Case No.:21/20/82-

ALC4/2015 Party Name:SHREE LIFE SCIENCES PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 250

Case No.:48/1/82-

ALC1/2016 Party Name:INDO AMINES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/01822/AM16/ RLA File :03/94/040/00785/AM16/ Lic.No/Date:0310801728 12.01.2016 Defer Date: 24.01.2017 Decision :Deferred. 251

Case No.:82/1/82-

ALC1/2016 Party Name:PRIVI ORGANICS LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 252

Case No.:62/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved

41 HQ File :01/82/050/01836/AM16/ RLA File :03/94/040/00833/AM16/ Lic.No/Date:0310801811 15.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/83/2016-PI(Norms) dated 21.12.2016, uploaded 253

Case No.:66/1/82-

ALC1/2016 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred for want of comments from DoP. 254

Case No.:79/1/82-

ALC1/2016 Party Name:PRIVI ORGANICS LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 255

Case No.:59/1/82-

ALC1/2016 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 256

Case No.:114/20/82-

ALC4/2015 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01697/AM16/ RLA File :34/24/040/00263/AM16/ Lic.No/Date:3410041814 19.01.2016 Defer Date: its meeting No.15/82 dated 31.10.2013, uploaded at the end of these minutes or as applied by the 257

Case No.:77/1/82-

ALC1/2016 Party Name:MEDISPRAY LABORATORIES PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 258

Case No.:50/1/82-

ALC1/2016 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017

42 Decision :Deferred. 259

Case No.:68/1/82-

ALC1/2016 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 260

Case No.:106/20/82-

ALC4/2015 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 261

Case No.:38/1/82-

ALC1/2016 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 262

Case No.:49/1/82-

ALC1/2016 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 263

Case No.:24/1/82-

ALC1/2016 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 264

Case No.:72/7/82-

ALC4/2016 Party Name:OGENE SYSTEMS INDIA LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00246/AM17/ RLA File :09/24/040/00620/AM16/ Lic.No/Date:0910063151 22.01.2016 Defer Date: 24.01.2017 265

Case No.:97/20/82-

ALC4/2015 Party Name:SHREE BANKEY BEHARI LAL AROMATICS Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01680/AM16/ RLA File :05/24/040/00522/AM16/ Lic.No/Date:0510397405 22.01.2016 Defer Date:

43 Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/28/2012-CH-II dated 30.09.2015, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 266

Case No.:96/20/82-

ALC4/2015 Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 267

Case No.:52/1/82-

ALC1/2016 Party Name:INDO AMINES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 268

Case No.:89/7/82-

ALC4/2016 Party Name:GLAND PHARMA LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00263/AM17/ RLA File :09/24/040/00623/AM16/ Lic.No/Date:0910063196 29.01.2016 Defer Date: Decision : The Committee decided to ratify norms based on the earlier recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/347/AM14-PI(Norms) dated 10.03.2015 uploaded 269

Case No.:88/7/82-

ALC4/2016 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00262/AM17/ RLA File :09/24/040/00304/AM16/ Lic.No/Date:0910063190 29.01.2016 Defer Date: 24.01.2017 270

Case No.:27/1/82-

ALC1/2016 Party Name:BODAL CHEMICALS LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 271

Case No.:44/1/82-

ALC1/2016 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017

44 272

Case No.:40/1/82-

ALC1/2016 Party Name:MAGNOLIA LIMITED. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 273

Case No.:3/5/82-

ALC4/2016 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00162/AM17/ RLA File :05/24/040/00537/AM16/ Lic.No/Date:0510397479 03.02.2016 Defer Date: 24.01.2017 274

Case No.:35/1/82-

ALC1/2016 Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/01809/AM16/ RLA File :31/82/040/00270/AM16/ Lic.No/Date:3110065907 04.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/40/2016-PI(Norms) dated 21.11.2016, uploaded 275

Case No.:37/1/82-

ALC1/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 276

Case No.:43/1/82-

ALC1/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 277

Case No.:58/1/82-

ALC1/2016 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 278

Case No.:69/1/82-

ALC1/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred for want of comments from DOP.

45 279

Case No.:39/1/82-

ALC1/2016 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 280

Case No.:45/1/82-

ALC1/2016 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 281

Case No.:79/7/82-

ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00253/AM17/ RLA File :09/24/040/00586/AM16/ Lic.No/Date:0910063240 10.02.2016 Defer Date: 24.01.2017 Decision : Information called for from the firm in NC meeting No.09/82 dated 10.08.2016 is awaited. The committee accordingly deferred the case. 282

Case No.:41/1/82-

ALC1/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 283

Case No.:78/1/82-

ALC1/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 284

Case No.:26/1/82-

ALC1/2016 Party Name:UMA ENTERPRISE Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 285

Case No.:56/1/82-

ALC1/2016 Party Name:ZIM LABORATORIES LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Information called for from the firm in NC meeting No.13/82 dated 16.11.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case.

46 286

Case No.:17/1/82-

ALC1/2016 Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/01791/AM16/ RLA File :04/24/040/00229/AM16/ Lic.No/Date:0410161613 17.02.2016 Defer Date: 24.01.2017 Decision :Deferred. 287

Case No.:57/1/82-

ALC1/2016 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 Decision :Deferred. 288

Case No.:87/7/82-

ALC4/2016 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: approved HQ File :01/82/050/00261/AM17/ RLA File :09/24/040/00696/AM16/ Lic.No/Date:0910063310 22.02.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.08/82 dated 25.09.2014, 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. 289

Case No.:78/7/82-

ALC4/2016 Party Name:VIVIMED LABS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00252/AM17/ RLA File :09/24/040/00592/AM16/ Lic.No/Date:0910063303 22.02.2016 Defer Date: 24.01.2017 Decision :Deferred. 290

Case No.:116/7/82-

ALC4/2016 Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00290/AM17/ RLA File :22/24/040/00111/AM16/ Lic.No/Date:2210015421 26.02.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION A-3647 published earlier vide P.No.64/2015-2020 dated 17.03.2015. RA concerned may calculate quantity on pro-rata basis as per decision of NC. 291

Case No.:12/7/82-

ALC4/2016 Party Name:MEDICLONE BIO-TECH PRIVATE LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00186/AM17/ RLA File :04/24/040/00250/AM16/ Lic.No/Date:0410161677 01.03.2016 Defer Date: 24.01.2017 Decision :Deferred for want of comments from DBT. 292 Case No.:82/7/82- Party Name:OPTIMUS Meet No/Date:15/82- Status:Deferred

47 ALC4/2016 DRUGS PRIVATE LIMITED ALC4/2016 15.12.2016 HQ File :01/82/050/00256/AM17/ RLA File :09/24/040/00721/AM16/ Lic.No/Date:0910063357 03.03.2016 Defer Date: 24.01.2017 293

Case No.:119/7/82-

ALC4/2016 Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00293/AM17/ RLA File :22/24/040/00121/AM16/ Lic.No/Date:2210015426 04.03.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION A-3647 published earlier vide P.No.64/2015-2020 dated 17.03.2015. RA concerned may calculate quantity on pro-rata basis 294

Case No.:118/7/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00292/AM17/ RLA File :22/24/040/00114/AM16/ Lic.No/Date:2210015440 09.03.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION A-3647 published earlier vide P.No.64/2015-2020 dated 17.03.2015. RA concerned may calculate quantity on pro-rata basis as per decision of NC. 295

Case No.:120/7/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00294/AM17/ RLA File :22/24/040/00113/AM16/ Lic.No/Date:2210015441 09.03.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION A-3647 published earlier vide P.No.64/2015-2020 dated 17.03.2015. RA concerned may calculate quantity on pro-rata basis 296

Case No.:59/7/82-

ALC4/2016 Party Name:RUCHI SOYA INDUSTRIES LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00233/AM17/ RLA File :56/24/040/00054/AM16/ Lic.No/Date:5610004864 11.03.2016 Defer Date: 24.01.2017 Decision :Deferred. 297

Case No.:24/2/82-

ALC4/2016 Party Name:SCOPE CHEMICALS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00024/AM17/ RLA File :03/95/040/00955/AM16/ Lic.No/Date:0310803229 11.03.2016 Defer Date: 24.01.2017 Decision :Deferred. 298

Case No.:100/7/82-

ALC4/2016 Party Name:CATAPHARMA CHEMICALS PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred

48 HQ File :01/82/050/00274/AM17/ RLA File :31/83/040/00174/AM16/ Lic.No/Date:3110066051 14.03.2016 Defer Date: 24.01.2017 299

Case No.:15/1/82-

ALC1/2016 Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 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: 24.01.2017 300

Case No.:107/7/82-

ALC4/2016 Party Name:ASTRAL STERITECH PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00281/AM17/ RLA File :34/24/040/00345/AM16/ Lic.No/Date:3410041995 21.03.2016 Defer Date: 24.01.2017 301

Case No.:109/7/82-

ALC4/2016 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00283/AM17/ RLA File :34/24/040/00336/AM16/ Lic.No/Date:3410041989 21.03.2016 Defer Date: 24.01.2017 Decision :Deferred. 302

Case No.:111/7/82-

ALC4/2016 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00285/AM17/ RLA File :34/24/040/00346/AM16/ Lic.No/Date:3410041992 21.03.2016 Defer Date: 24.01.2017 Decision :Deferred. 303

Case No.:122/7/82-

ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00296/AM17/ RLA File :03/94/040/01019/AM16/ Lic.No/Date:0310803499 22.03.2016 Defer Date: its meeting No.1/82 dated 10.04.2014, uploaded at the end of these minutes or as applied by the 304

Case No.:48/4/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00111/AM17/ RLA File :03/94/040/01067/AM16/ Lic.No/Date:0310803525 23.03.2016 Defer Date: 24.01.2017 Decision :Deferred. 305 Case No.:57/7/82- ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:15/82- ALC4/2016 Status: Approved

49 15.12.2016 HQ File :01/82/050/00231/AM17/ RLA File :22/24/040/00125/AM16/ Lic.No/Date:2210015455 23.03.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION A-3647 published earlier vide P.No.64/2015-2020 dated 17.03.2015. RA concerned may calculate quantity on pro-rata basis 306

Case No.:61/7/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00235/AM17/ RLA File :22/24/040/00127/AM16/ Lic.No/Date:2210015457 23.03.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION A-3647 published earlier vide P.No.64/2015-2020 dated 17.03.2015. RA concerned may calculate quantity on pro-rata basis 307

Case No.:62/7/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00236/AM17/ RLA File :22/24/040/00128/AM16/ Lic.No/Date:2210015456 23.03.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION A-3647 published earlier vide P.No.64/2015-2020 dated 17.03.2015. RA concerned may calculate quantity on pro-rata basis 308

Case No.:60/11/82-

ALC4/2016 Party Name:GRANULES INDIA LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00594/AM17/ RLA File :09/24/040/00759/AM16/ Lic.No/Date:0910063450 29.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/270/2016-PI(Norms) dated October, 2016 uploaded at the end of these minutes, or as applied by the firm whichever is less under Para 4.07 of HBP. RA concerned may take further necessary action as per decision of NC. 309

Case No.:39/7/82-

ALC4/2016 Party Name:POSY PHARMACHEM PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00213/AM17/ RLA File :08/24/040/00426/AM16/ Lic.No/Date:0810137551 30.03.2016 Defer Date: 24.01.2017 310

Case No.:58/7/82-

ALC4/2016 Party Name:VENUS REMEDIES LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00232/AM17/ RLA File :22/24/040/00133/AM16/ Lic.No/Date:2210015463 31.03.2016 Defer Date: 24.01.2017 311

Case No.:138/7/82-

ALC4/2016 Party Name:ALTA LABORATORIES LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred

50 HQ File :01/82/050/00312/AM17/ RLA File :03/94/040/01112/AM16/ Lic.No/Date:0310803707 01.04.2016 Defer Date: 24.01.2017 312

Case No.:81/11/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00615/AM17/ RLA File :03/94/040/01096/AM16/ Lic.No/Date:0310803709 01.04.2016 Defer Date: 24.01.2017 313

Case No.:104/7/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00278/AM17/ RLA File :05/23/040/00556/AM16/ Lic.No/Date:0510398125 01.04.2016 Defer Date: 24.01.2017 Decision :Deferred. 314

Case No.:121/7/82-

ALC4/2016 Party Name:VARUN MEDIMPEX INC. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00295/AM17/ RLA File :05/24/040/00632/AM16/ Lic.No/Date:0510398119 01.04.2016 Defer Date: Decision : The Committee decided to ratify norms based on the decision taken by NC in its meeting No.09/82 dated 20.10.2014 uploaded at the end of these minutes, or as applied by the firm whichever is less under Para 4.07 of HBP. RA concerned may take further necessary action 315

Case No.:24/7/82-

ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00198/AM17/ RLA File :31/83/040/00186/AM16/ Lic.No/Date:3110066111 05.04.2016 Defer Date: 24.01.2017 Decision :Deferred. 316

Case No.:38/7/82-

ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00212/AM17/ RLA File :05/23/040/00571/AM16/ Lic.No/Date:0510398134 05.04.2016 Defer Date: 24.01.2017 317

Case No.:105/7/82-

ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00279/AM17/ RLA File :05/23/040/00573/AM16/ Lic.No/Date:0510398133 05.04.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/789/2015-PI(Norms) dated 18.07.2016 uploaded at the end of these minutes, or as applied by the firm whichever is less under Para 4.07 of HBP.

51 RA concerned may take further necessary action as per decision of NC. 318

Case No.:106/7/82-

ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00280/AM17/ RLA File :05/23/040/00570/AM16/ Lic.No/Date:0510398132 05.04.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION published for injection. RA concerned may take further necessary action as per decision of NC. 319

Case No.:123/7/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00297/AM17/ RLA File :03/94/040/01038/AM16/ Lic.No/Date:0310803819 06.04.2016 Defer Date: 24.01.2017 320

Case No.:42/7/82-

ALC4/2016 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00216/AM17/ RLA File :34/24/040/00325/AM16/ Lic.No/Date:3410042036 07.04.2016 Defer Date: 24.01.2017 Decision : 321

Case No.:43/7/82-

ALC4/2016 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00217/AM17/ RLA File :34/24/040/00355/AM16/ Lic.No/Date:3410042037 07.04.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/167/2016-PI(Norms) dated 28.11.2016, uploaded 322

Case No.:52/7/82-

ALC4/2016 Party Name:FINE CURE PHARMACEUTICALS LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00226/AM17/ RLA File :08/24/040/00460/AM16/ Lic.No/Date:0810137652 11.04.2016 Defer Date: 24.01.2017 323

Case No.:45/7/82-

ALC4/2016 Party Name:ASTRAL STERITECH PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00219/AM17/ RLA File :34/24/040/00009/AM17/ Lic.No/Date:3410042064 13.04.2016 Defer Date: 24.01.2017 324

Case No.:87/11/82-

ALC4/2016 Party Name:KLJ PLASTICIZERS LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred

52 HQ File :01/82/050/00621/AM17/ RLA File :05/23/040/00554/AM16/ Lic.No/Date:0510398217 13.04.2016 Defer Date: 24.01.2017 Decision :Deferred. 325

Case No.:50/7/82-

ALC4/2016 Party Name:BODAL CHEMICALS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00224/AM17/ RLA File :08/24/040/00005/AM17/ Lic.No/Date:0810137692 18.04.2016 Defer Date: 24.01.2017 Decision :Deferred. 326

Case No.:33/7/82-

ALC4/2016 Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00207/AM17/ RLA File :05/23/040/00018/AM17/ Lic.No/Date:0510398279 22.04.2016 Defer Date: 24.01.2017 327

Case No.:15/7/82-

ALC4/2016 Party Name:SUPREET CHEMICALS PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00189/AM17/ RLA File :52/24/040/00006/AM17/ Lic.No/Date:5210041869 25.04.2016 Defer Date: 24.01.2017 Decision :Deferred. 328

Case No.:125/7/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00299/AM17/ RLA File :03/95/040/00061/AM17/ Lic.No/Date:0310804144 25.04.2016 Defer Date: its meeting No.6/82 dated 13.06.2013, uploaded at the end of these minutes or as applied by the 329

Case No.:126/7/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00300/AM17/ RLA File :03/95/040/00064/AM17/ Lic.No/Date:0310804154 25.04.2016 Defer Date: its meeting No.10/82 dated 22.08.2013, uploaded at the end of these minutes or as applied by the 330

Case No.:145/7/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00319/AM17/ RLA File :03/94/040/00072/AM17/ Lic.No/Date:0310804202 26.04.2016 Defer Date:

53 Pharmaceuticals forwarded vide O.M.No.35011/783/2015-PI(Norms) dated 22.08.2016 uploaded RA concerned may take further necessary action as per decision of NC. 331

Case No.:144/7/82-

ALC4/2016 Party Name:GOLD STAR CHEMICALS PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00318/AM17/ RLA File :03/94/040/01042/AM16/ Lic.No/Date:0310804172 26.04.2016 Defer Date: 24.01.2017 Decision :Deferred. 332

Case No.:148/7/82-

ALC4/2016 Party Name:HEMA DYE CHEM PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00322/AM17/ RLA File :03/94/040/00055/AM17/ Lic.No/Date:0310804211 26.04.2016 Defer Date: 24.01.2017 Decision :Deferred. 333

Case No.:127/7/82-

ALC4/2016 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00301/AM17/ RLA File :03/95/040/00048/AM17/ Lic.No/Date:0310804183 26.04.2016 Defer Date: 24.01.2017 Decision :Deferred. 334

Case No.:128/7/82-

ALC4/2016 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00302/AM17/ RLA File :03/95/040/00049/AM17/ Lic.No/Date:0310804184 26.04.2016 Defer Date: 24.01.2017 Decision :Deferred. 335

Case No.:32/7/82-

ALC4/2016 Party Name:HELLO PAINTS (P) LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00206/AM17/ RLA File :05/23/040/00036/AM17/ Lic.No/Date:0510398321 27.04.2016 Defer Date: 24.01.2017 Decision :Deferred. 336

Case No.:130/7/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00304/AM17/ RLA File :03/95/040/00068/AM17/ Lic.No/Date:0310804238 27.04.2016 Defer Date: its meeting No.6/82 dated 13.06.2013, uploaded at the end of these minutes or as applied by the

54 337

Case No.:146/7/82-

ALC4/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00320/AM17/ RLA File :03/94/040/00012/AM17/ Lic.No/Date:0310804283 29.04.2016 Defer Date: 24.01.2017 338

Case No.:147/7/82-

ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00321/AM17/ RLA File :03/94/040/00063/AM17/ Lic.No/Date:0310804284 29.04.2016 Defer Date: its meeting No.10/82 dated 05.06.2012, uploaded at the end of these minutes or as applied by 339

Case No.:142/7/82-

ALC4/2016 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00316/AM17/ RLA File :03/94/040/01101/AM16/ Lic.No/Date:0310804342 02.05.2016 Defer Date: 24.01.2017 340

Case No.:129/7/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00303/AM17/ RLA File :03/95/040/00004/AM17/ Lic.No/Date:0310804339 02.05.2016 Defer Date: 24.01.2017 Decision :Copy of application has been sent to MSME for comments. 341

Case No.:75/7/82-

ALC4/2016 Party Name:ALKALOIDS CORPORATION Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00249/AM17/ RLA File :02/24/040/00016/AM17/ Lic.No/Date:0210206661 04.05.2016 Defer Date: 24.01.2017 342

Case No.:6/11/82-

ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00540/AM17/ RLA File :09/24/040/00052/AM17/ Lic.No/Date:0910063584 05.05.2016 Defer Date: 24.01.2017 Decision :deferred for want of comments from DoP. 343

Case No.:49/7/82-

ALC4/2016 Party Name:PANACEA BIOTEC LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00223/AM17/ RLA File :05/24/040/00009/AM17/ Lic.No/Date:0510398392 05.05.2016 Defer Date: 24.01.2017

55 Decision :Deferred for want of comments from DBT. 344

Case No.:8/7/82-

ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00182/AM17/ RLA File :04/24/040/00009/AM17/ Lic.No/Date:0410161871 05.05.2016 Defer Date: 24.01.2017 Decision : The Committee noted that information called for from the firm by NC in its meeting No.11/82 dated 07.09.2016 is awaited. The Committee accordingly decided to await the reply from the firm and deferred the case. 345

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

SHASUN LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00183/AM17/ RLA File :04/24/040/00010/AM17/ Lic.No/Date:0410161872 05.05.2016 Defer Date: 24.01.2017 Decision : The Committee noted that information called for from the firm by NC in its meeting No.11/82 dated 07.09.2016 is awaited. The Committee accordingly decided to await the reply from the firm and deferred the case. 346

Case No.:163/7/82-

ALC4/2016 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00337/AM17/ RLA File :03/94/040/00090/AM17/ Lic.No/Date:0310804480 09.05.2016 Defer Date: 24.01.2017 Decision :Deferred. 347

Case No.:141/7/82-

ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00315/AM17/ RLA File :03/94/040/00041/AM17/ Lic.No/Date:0310804465 09.05.2016 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.18/82 dated 30.08.2012, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 348

Case No.:17/7/82-

ALC4/2016 Party Name:CONTINENTAL CHEMICALS Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00191/AM17/ RLA File :08/24/040/00045/AM17/ Lic.No/Date:0810137878 09.05.2016 Defer Date: 24.01.2017 Decision :Deferred. 349

Case No.:18/7/82-

ALC4/2016 Party Name:CONTINENTAL CHEMICALS Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00192/AM17/ RLA File :08/24/040/00044/AM17/ Lic.No/Date:0810137877 09.05.2016 Defer Date: 24.01.2017 Decision :Deferred. 350

Case No.:161/7/82-

ALC4/2016 Party Name:GITANJALI CHEMICALS PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: HQ File RLA File Lic.No/Date:0310804504 Defer Date:

56 :01/82/050/00335/AM17/ :03/94/040/00026/AM17/ 09.05.2016 Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.14/82 dated 24.10.2013, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 351

Case No.:51/7/82-

ALC4/2016 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00225/AM17/ RLA File :05/23/040/00539/AM16/ Lic.No/Date:0510398432 09.05.2016 Defer Date: 24.01.2017 Decision :Deferred. 352

Case No.:159/7/82-

ALC4/2016 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00333/AM17/ RLA File :03/94/040/00061/AM17/ Lic.
No/Date:0310804534 10.05.2016 Defer Date: 24.01.2017 Decision :Deferred. 353

Case No.:160/7/82-

ALC4/2016 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00334/AM17/ RLA File :03/94/040/00036/AM17/ Lic.No/Date:0310804533 10.05.2016 Defer Date: 24.01.2017 Decision :Deferred. 354

Case No.:76/7/82-

ALC4/2016 KABI ONCOLOGY LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00250/AM17/ RLA File :05/23/040/00031/AM17/ Lic.No/Date:0510398443 10.05.2016 Defer Date: 24.01.2017 Decision :Deferred. 355

Case No.:137/7/82-

ALC4/2016 Party Name:RELIANCE INDUSTRIES LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00311/AM17/ RLA File :03/95/040/00763/AM16/ Lic.No/Date:0310804513 10.05.2016 Defer Date: 24.01.2017 Decision :Deferred. 356

Case No.:84/11/82-

ALC4/2016 Party Name:NEULAND LABORATORIES LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: approved HQ File :01/82/050/00618/AM17/ RLA File :09/24/040/00039/AM17/ Lic.No/Date:0910063615 11.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/272/2013-PI(Norms) dated 24.06.2013 uploaded

57 357

Case No.:157/7/82-

ALC4/2016 Party Name:APEX PHARMA, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00331/AM17/ RLA File :03/94/040/00122/AM17/ Lic.No/Date:0310804628 12.05.2016 Defer Date: 24.01.2017 Decision :Deferred. 358

Case No.:74/7/82-

ALC4/2016 Party Name:KLJ PLASTICIZERS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00248/AM17/ RLA File :05/23/040/00050/AM17/ Lic.No/Date:0510398481 12.05.2016 Defer Date: 24.01.2017 Decision :Deferred. 359

Case No.:158/7/82-

ALC4/2016 Party Name:KUBO COMBUSTION EFFICIENCY CHEMICALS PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00332/AM17/ RLA File :03/94/040/01064/AM16/ Lic.No/Date:0310804642 12.05.2016 Defer Date: its meeting No.01/82 dated 04.04.2013, uploaded at the end of these minutes or as applied by the 360

Case No.:131/7/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00305/AM17/ RLA File :03/95/040/00016/AM17/ Lic.No/Date:0310804666 13.05.2016 Defer Date: 24.01.2017 Decision :Deferred. 361

Case No.:86/11/82-

ALC4/2016 Party Name:ALMELO PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00620/AM17/ RLA File :09/24/040/00056/AM17/ Lic.No/Date:0910063626 17.05.2016 Defer Date: 24.01.2017 362

Case No.:85/11/82-

ALC4/2016 Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00619/AM17/ RLA File :09/24/040/00028/AM17/ Lic.No/Date:0910063644 17.05.2016 Defer Date: 24.01.2017 363

Case No.:82/11/82-

ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00616/AM17/ RLA File :05/24/040/00624/AM16/ Lic.No/Date:0510398507 17.05.2016 Defer Date: 24.01.2017

58 364

Case No.:83/11/82-

ALC4/2016 Party Name:BIOLOGICAL E LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00617/AM17/ RLA File :09/24/040/00307/AM15/ Lic.No/Date:0910063658 19.05.2016 Defer Date: 24.01.2017 365

Case No.:132/7/82-

ALC4/2016 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00306/AM17/ RLA File :03/95/040/00118/AM17/ Lic.No/Date:0310804885 20.05.2016 Defer Date: 24.01.2017 Decision :Deferred. 366

Case No.:139/7/82-

ALC4/2016 Party Name:GANGWAL CHEMICALS (P) LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00313/AM17/ RLA File :03/94/040/00149/AM17/ Lic.No/Date:0310804914 23.05.2016 Defer Date: 24.01.2017 Decision :Deferred. 367

Case No.:140/7/82-

ALC4/2016 Party Name:GANGWAL CHEMICALS (P) LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00314/AM17/ RLA File :03/94/040/00148/AM17/ Lic.No/Date:0310804913 23.05.2016 Defer Date: 24.01.2017 Decision :Deferred. 368

Case No.:153/7/82-

ALC4/2016 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00327/AM17/ RLA File :03/94/040/00115/AM17/ Lic.No/Date:0310804948 24.05.2016 Defer Date: 24.01.2017 Decision :Deferred. 369

Case No.:152/7/82-

ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00326/AM17/ RLA File :03/94/040/00152/AM17/ Lic.No/Date:0310804950 24.05.2016 Defer Date: its meeting No.22/82 dated 20.02.2014, uploaded at the end of these minutes or as applied by 370

Case No.:134/7/82-

ALC4/2016 Party Name:ORBIT LIFE SCIENCE PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File RLA File Lic.No/Date:0310804944 Defer Date:

59 :01/82/050/00308/AM17/ :03/95/040/00069/AM17/ 24.05.2016 24.01.2017 371

Case No.:88/11/82-

ALC4/2016 Party Name:ESTEEM INDUSTRIES PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00622/AM17/ RLA File :17/24/040/00027/AM17/ Lic.No/Date:1710006342 26.05.2016 Defer Date: Decision The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.33/82 dated 21.03.2013, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 372

Case No.:43/10/82-

ALC4/2016 Party Name:O C SPECIALITIES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00389/AM17/ RLA File :03/95/040/00169/AM17/ Lic.No/Date:0310805124 01.06.2016 Defer Date: 24.01.2017 Decision :Deferred. 373

Case No.:2/11/82-

ALC4/2016 Party Name:MANALI PETROCHEMICALS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00536/AM17/ RLA File :04/24/040/00270/AM16/ Lic.No/Date:0410162005 02.06.2016 Defer Date: 24.01.2017 Decision :Deferred. 374

Case No.:1/11/82-

ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00535/AM17/ RLA File :05/23/040/00110/AM17/ Lic.No/Date:0510398726 03.06.2016 Defer Date: 24.01.2017 375

Case No.:8/11/82-

ALC4/2016 Party Name:SOFTGEL HEALTH CARE PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00542/AM17/ RLA File :04/24/040/00042/AM17/ Lic.No/Date:0410162009 03.06.2016 Defer Date: 24.01.2017 376

Case No.:61/11/82-

ALC4/2016 Party Name:KEKULE PHARMA LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00595/AM17/ RLA File :09/24/040/00017/AM17/ Lic.No/Date:0910063781 09.06.2016 Defer Date: 24.01.2017 377

Case No.:29/13/82-

ALC4/2016 Party Name:KUTCH CHEMICAL INDUSTRIES LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred

60 HQ File :01/82/050/00657/AM17/ RLA File :34/24/040/00068/AM17/ Lic.No/Date:3410042260 10.06.2016 Defer Date: 24.01.2017 378

Case No.:62/11/82-

ALC4/2016 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00596/AM17/ RLA File :09/24/040/00077/AM17/ Lic.No/Date:0910063788 10.06.2016 Defer Date: 24.01.2017 Decision :Deferred. 379

Case No.:64/11/82-

ALC4/2016 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00598/AM17/ RLA File :09/24/040/00076/AM17/ Lic.No/Date:0910063789 10.06.2016 Defer Date: 24.01.2017 Decision :Deferred. 380

Case No.:89/13/82-

ALC4/2016 Party Name:UMA ENTERPRISE Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00717/AM17/ RLA File :08/24/040/00099/AM17/ Lic.No/Date:0810138154 10.06.2016 Defer Date: 24.01.2017 Decision :Deferred. 381

Case No.:3/11/82-

ALC4/2016 Party Name:DANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00537/AM17/ RLA File :03/94/040/00151/AM17/ Lic.No/Date:0310805608 20.06.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/635/2015-PI(Norms) dated December 2015 382

Case No.:1/7/82-

ALC4/2016 Party Name:NEULAND LABORATORIES LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00175/AM17/ RLA File :09/24/040/00139/AM17/ Lic.No/Date:0910063809 21.06.2016 Defer Date: 24.01.2017 383

Case No.:30/13/82-

ALC4/2016 Party Name:ESTEEM INDUSTRIES PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00658/AM17/ RLA File :17/24/040/00050/AM17/ Lic.No/Date:1710006371 24.06.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision

61 taken by NC in its meeting No.04/82 dated 16.05.2013, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 384

Case No.:5/11/82-

ALC4/2016 Party Name:ASCENT FINECHEM PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00539/AM17/ RLA File :08/24/040/00104/AM17/ Lic.No/Date:0810138218 28.06.2016 Defer Date: 24.01.2017 Decision :Deferred. 385

Case No.:16/11/82-

ALC4/2016 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00550/AM17/ RLA File :03/95/040/00255/AM17/ Lic.No/Date:0310805798 29.06.2016 Defer Date: 24.01.2017 Decision :Deferred. 386

Case No.:45/11/82-

ALC4/2016 Party Name:KUBO COMBUSTION EFFICIENCY CHEMICALS PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00579/AM17/ RLA File :03/94/040/00249/AM17/ Lic.No/Date:0310805832 30.06.2016 Defer Date: its meeting No.01/82 dated 04.04.2013, uploaded at the end of these minutes or as applied by the 387

Case No.:7/11/82-

ALC4/2016 Party Name:PANERA BIOTEC PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00541/AM17/ RLA File :05/24/040/00136/AM17/ Lic.No/Date:0510398951 30.06.2016 Defer Date: 24.01.2017 Decision : Deferred for want of comments from DBT. 388

Case No.:14/11/82-

ALC4/2016 Party Name:PALADIN PAINTS AND CHEMICALS PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00548/AM17/ RLA File :03/95/040/00277/AM17/ Lic.No/Date:0310805923 04.07.2016 Defer Date: 24.01.2017 Decision :Deferred. 389

Case No.:50/11/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00584/AM17/ RLA File :03/94/040/00275/AM17/ Lic.No/Date:0310805959 05.07.2016 Defer Date: 24.01.2017

62 390

Case No.:53/11/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00587/AM17/ RLA File :03/94/040/00273/AM17/ Lic.No/Date:0310805958 05.07.2016 Defer Date: 24.01.2017 391

Case No.:48/11/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00582/AM17/ RLA File :03/94/040/00255/AM17/ Lic.No/Date:0310805960 05.07.2016 Defer Date: 24.01.2017 392

Case No.:3/13/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00631/AM17/ RLA File :05/24/040/00143/AM17/ Lic.No/Date:0510399022 06.07.2016 Defer Date: 24.01.2017 393

Case No.:36/13/82-

ALC4/2016 Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00664/AM17/ RLA File :22/24/040/00030/AM17/ Lic.No/Date:2210015519 08.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/75/2016-PI(Norms) dated July 2016 uploaded at the end of these minutes, or as applied by the firm whichever is less under Para 4.07 of HBP. RA concerned may take further necessary action as per decision of NC. 394

Case No.:39/13/82-

ALC4/2016 Party Name:VIRDEV INTERMEDIATES PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00667/AM17/ RLA File :52/24/040/00022/AM17/ Lic.No/Date:5210041951 08.07.2016 Defer Date: 24.01.2017 Decision :Deferred. 395

Case No.:12/11/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: approved HQ File :01/82/050/00546/AM17/ RLA File :03/95/040/00285/AM17/ Lic.No/Date:0310806007 08.07.2016 Defer Date: its meeting No.6/82 dated 13.06.2013, uploaded at the end of these minutes or as applied by the 396 Case No.:28/13/82- Party Name:CAMPHOR & Meet No/Date:15/82- Status:

63 ALC4/2016 ALLIED PRODUCTS LIMITED, ALC4/2016 15.12.2016 Approved HQ File :01/82/050/00656/AM17/ RLA File :03/94/040/00997/AM16/ Lic.No/Date:0310806094 11.07.2016 Defer Date: its meeting No.16/82 dated 21.11.2013, uploaded at the end of these minutes or as applied by the 397

Case No.:1/13/82-

ALC4/2016 KABI ONCOLOGY LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00629/AM17/ RLA File :05/23/040/00168/AM17/ Lic.No/Date:0510399049 11.07.2016 Defer Date: 24.01.2017 Decision :Deferred for want of comments from DoP. 398

Case No.:37/13/82-

ALC4/2016 Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00665/AM17/ RLA File :22/24/040/00029/AM17/ Lic.No/Date:2210015520 11.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/597/2012-PI(Norms) dated 06.02.2013 uploaded 399

Case No.:13/11/82-

ALC4/2016 Party Name:S M CHEMICAL VAPI PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00547/AM17/ RLA File :03/95/040/00225/AM17/ Lic.No/Date:0310806063 11.07.2016 Defer Date: 24.01.2017 Decision :Deferred. 400

Case No.:42/11/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00576/AM17/ RLA File :03/94/040/00198/AM17/ Lic.No/Date:0310806121 12.07.2016 Defer Date: 24.01.2017 401

Case No.:43/11/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00577/AM17/ RLA File :03/94/040/00105/AM17/ Lic.No/Date:0310806120 12.07.2016 Defer Date: 24.01.2017 402

Case No.:39/11/82-

ALC4/2016 ALLIED PRODUCTS LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File RLA File Lic.No/Date:0310806146 Defer Date:

64 :01/82/050/00573/AM17/ :03/94/040/00966/AM16/ 12.07.2016 its meeting No.16/82 dated 21.11.2013, uploaded at the end of these minutes or as applied by the 403

Case No.:9/11/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00543/AM17/ RLA File :03/94/040/00277/AM17/ Lic.No/Date:0310806159 12.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/783/2015-PI(Norms) dated 22.08.2016 uploaded 404

Case No.:24/11/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00558/AM17/ RLA File :03/94/040/00272/AM17/ Lic.No/Date:0310806154 12.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/783/2015-PI(Norms) dated 22.08.2016 uploaded 405

Case No.:46/11/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00580/AM17/ RLA File :03/94/040/00276/AM17/ Lic.No/Date:0310806157 12.07.2016 Defer Date: 24.01.2017 406

Case No.:47/11/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00581/AM17/ RLA File :03/94/040/00274/AM17/ Lic.No/Date:0310806156 12.07.2016 Defer Date: 24.01.2017 407

Case No.:40/11/82-

ALC4/2016 Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00574/AM17/ RLA File :03/94/040/00237/AM17/ Lic.No/Date:0310806115 12.07.2016 Defer Date: 24.01.2017 Decision :Deferred. 408

Case No.:52/11/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File RLA File Lic.No/Date:0310806113 Defer Date:

65 :01/82/050/00586/AM17/ :03/94/040/00288/AM17/ 12.07.2016 24.01.2017 409

Case No.:32/13/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00660/AM17/ RLA File :03/94/040/00291/AM17/ Lic.No/Date:0310806165 12.07.2016 Defer Date: 24.01.2017 410

Case No.:41/11/82-

ALC4/2016 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00575/AM17/ RLA File :03/94/040/01110/AM16/ Lic.No/Date:0310806126 12.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/819/2015-PI(Norms) dated 05.05.2016 uploaded 411

Case No.:89/11/82-

ALC4/2016 Party Name:MALWA OXYGEN & INDUSTRIAL GASES PVT.LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00623/AM17/ RLA File :56/24/040/00015/AM17/ Lic.No/Date:5610004949 12.07.2016 Defer Date: 24.01.2017 Decision :Deferred. 412

Case No.:4/11/82-

ALC4/2016 Party Name:ATUL LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00538/AM17/ RLA File :08/24/040/00113/AM17/ Lic.No/Date:0810138282 13.07.2016 Defer Date: 24.01.2017 Decision :Deferred. 413

Case No.:57/11/82-

ALC4/2016 Party Name:ZIM LABORATORIES LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00591/AM17/ RLA File :03/95/040/00296/AM17/ Lic.No/Date:0310806194 13.07.2016 Defer Date: 24.01.2017 414

Case No.:68/11/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00602/AM17/ RLA File :08/24/040/00116/AM17/ Lic.No/Date:0810138288 14.07.2016 Defer Date: 24.01.2017 415 Case No.:73/11/82- Party Name:DHANUKA Meet No/Date:15/82- Status:Deferred

66 ALC4/2016 LABORATORIES LTD. ALC4/2016 15.12.2016 HQ File :01/82/050/00607/AM17/ RLA File :05/23/040/00192/AM17/ Lic.No/Date:0510399089 14.07.2016 Defer Date: 24.01.2017 416

Case No.:2/13/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00630/AM17/ RLA File :05/23/040/00194/AM17/ Lic.No/Date:0510399087 14.07.2016 Defer Date: 24.01.2017 Decision :Deferred. 417

Case No.:10/11/82-

ALC4/2016 Party Name:MATRIX FINE SCIENCES PVT.LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00544/AM17/ RLA File :03/95/040/00304/AM17/ Lic.No/Date:0310806238 14.07.2016 Defer Date: 24.01.2017 418

Case No.:56/11/82-

ALC4/2016 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00590/AM17/ RLA File :03/95/040/00746/AM16/ Lic.No/Date:0310806245 14.07.2016 Defer Date: 24.01.2017 Decision :Copy of application has been sent to MSME for comments. 419

Case No.:54/11/82-

ALC4/2016 Party Name:SWISS PARENTERALS PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00588/AM17/ RLA File :08/24/040/00138/AM17/ Lic.No/Date:0810138287 14.07.2016 Defer Date: 24.01.2017 420

Case No.:69/11/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: approved HQ File :01/82/050/00603/AM17/ RLA File :08/24/040/00146/AM17/ Lic.No/Date:0810138302 15.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/300/2013-PI(Norms) dated 24.06.2013 uploaded 421

Case No.:72/11/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00606/AM17/ RLA File :08/24/040/00145/AM17/ Lic.No/Date:0810138301 15.07.2016 Defer Date: 24.01.2017

67 422

Case No.:38/11/82-

ALC4/2016 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00572/AM17/ RLA File :03/94/040/00224/AM17/ Lic.No/Date:0310806304 15.07.2016 Defer Date: 24.01.2017 423

Case No.:4/13/82-

ALC4/2016 Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00632/AM17/ RLA File :05/24/040/00165/AM17/ Lic.No/Date:0510399093 15.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/201/2016-PI(Norms) dated August 2016 424

Case No.:5/13/82-

ALC4/2016 Party Name:SHREE BANKEY BEHARI LAL AROMATICS Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: approved HQ File :01/82/050/00633/AM17/ RLA File :05/24/040/00157/AM17/ Lic.No/Date:0510399096 15.07.2016 Defer Date: its meeting No.11/82 dated 26.11.2014 uploaded at the end of these minutes, or as applied by the firm whichever is less under Para 4.07 of HBP. RA concerned may take further necessary action 425

Case No.:34/11/82-

ALC4/2016 ALLIED PRODUCTS LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00568/AM17/ RLA File :03/94/040/00114/AM17/ Lic.No/Date:0310806356 18.07.2016 Defer Date: its meeting No.17/82 dated 05.12.2013 uploaded at the end of these minutes, or as applied by the firm whichever is less under Para 4.07 of HBP. RA concerned may take further necessary action 426

Case No.:37/11/82-

ALC4/2016 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00571/AM17/ RLA File :03/94/040/00220/AM17/ Lic.No/Date:0310806338 18.07.2016 Defer Date: 24.01.2017 427

Case No.:36/11/82-

ALC4/2016 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00570/AM17/ RLA File :03/94/040/00226/AM17/ Lic.No/Date:0310806366 18.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/819/2015-PI(Norms) dated 05.05.2016 uploaded

68 428

Case No.:23/11/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00557/AM17/ RLA File :03/94/040/00301/AM17/ Lic.No/Date:0310806378 19.07.2016 Defer Date: 24.01.2017 429

Case No.:67/11/82-

ALC4/2016 KABI ONCOLOGY LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00601/AM17/ RLA File :05/23/040/00065/AM17/ Lic.No/Date:0510399129 19.07.2016 Defer Date: 24.01.2017 430

Case No.:66/11/82-

ALC4/2016 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00600/AM17/ RLA File :05/23/040/00147/AM17/ Lic.No/Date:0510399130 19.07.2016 Defer Date: 24.01.2017 Decision :Deferred. 431

Case No.:21/11/82-

ALC4/2016 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00555/AM17/ RLA File :03/95/040/00206/AM17/ Lic.No/Date:0310806373 19.07.2016 Defer Date: 24.01.2017 Decision :copy of application has been sent to MSME fro comments. 432

Case No.:18/11/82-

ALC4/2016 Party Name:RESONANCE SPECIALTIES LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00552/AM17/ RLA File :03/95/040/00262/AM17/ Lic.No/Date:0310806401 19.07.2016 Defer Date: 24.01.2017 Decision :Deferred. 433

Case No.:35/11/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00569/AM17/ RLA File :03/94/040/00283/AM17/ Lic.No/Date:0310806427 20.07.2016 Defer Date: 24.01.2017 434

Case No.:74/11/82-

ALC4/2016 Party Name:KLJ PLASTICIZERS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00608/AM17/ RLA File :05/23/040/00195/AM17/ Lic.No/Date:0510399160 20.07.2016 Defer Date: 24.01.2017

69 Decision :Deferred. 435

Case No.:118/13/82-

ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00746/AM17/ RLA File :07/24/040/00129/AM17/ Lic.No/Date:0710110138 21.07.2016 Defer Date: its meeting No.46/82 dated 09.02.2010, uploaded at the end of these minutes or as applied by the 436

Case No.:19/11/82-

ALC4/2016 Party Name:REANNON PHARMACEUTICALS Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00553/AM17/ RLA File :03/95/040/00326/AM17/ Lic.No/Date:0310806484 21.07.2016 Defer Date: 24.01.2017 437

Case No.:83/13/82-

ALC4/2016 Party Name:REANNON PHARMACEUTICALS Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00711/AM17/ RLA File :03/95/040/00327/AM17/ Lic.No/Date:0310806482 21.07.2016 Defer Date: 24.01.2017 438

Case No.:25/11/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00559/AM17/ RLA File :03/95/040/00180/AM17/ Lic.No/Date:0310806477 21.07.2016 Defer Date: 24.01.2017 Decision :Deferred. 439

Case No.:26/11/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00560/AM17/ RLA File :03/95/040/00116/AM17/ Lic.No/Date:0310806480 21.07.2016 Defer Date: 24.01.2017 Decision :Deferred. 440

Case No.:27/11/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00561/AM17/ RLA File :03/95/040/00143/AM17/ Lic.No/Date:0310806474 21.07.2016 Defer Date: 24.01.2017 Decision :Deferred. 441

Case No.:20/13/82-

ALC4/2016 KABI ONCOLOGY LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File RLA File Lic.No/Date:0510399202 Defer Date:

70 :01/82/050/00648/AM17/ :05/23/040/00211/AM17/ 22.07.2016 24.01.2017 442

Case No.:20/11/82-

ALC4/2016 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00554/AM17/ RLA File :03/95/040/00498/AM16/ Lic.No/Date:0310806509 22.07.2016 Defer Date: 24.01.2017 Decision :Deferred. 443

Case No.:31/11/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00565/AM17/ RLA File :03/95/040/00168/AM17/ Lic.No/Date:0310806532 22.07.2016 Defer Date: 24.01.2017 Decision :Deferred. 444

Case No.:7/13/82-

ALC4/2016 Party Name:STYRAX PHARMA PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00635/AM17/ RLA File :26/24/040/00013/AM17/ Lic.No/Date:2610012765 22.07.2016 Defer Date: 24.01.2017 445

Case No.:70/11/82-

ALC4/2016 Party Name:ARCHI EXIM PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00604/AM17/ RLA File :08/24/040/00150/AM17/ Lic.No/Date:0810138353 25.07.2016 Defer Date: 24.01.2017 Decision :Deferred. 446

Case No.:71/11/82-

ALC4/2016 Party Name:ARCHI EXIM PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00605/AM17/ RLA File :08/24/040/00151/AM17/ Lic.No/Date:0810138354 25.07.2016 Defer Date: 24.01.2017 Decision : 447

Case No.:144/13/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00772/AM17/ RLA File :08/24/040/00154/AM17/ Lic.No/Date:0810138352 25.07.2016 Defer Date: 24.01.2017 448

Case No.:32/11/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00566/AM17/ RLA File :03/95/040/00290/AM17/ Lic.No/Date:0310806544 25.07.2016 Defer Date: 24.01.2017

71 Decision :Deferred. 449

Case No.:55/11/82-

ALC4/2016 Party Name:SWISS PARENTERALS PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00589/AM17/ RLA File :08/24/040/00156/AM17/ Lic.No/Date:0810138362 25.07.2016 Defer Date: 24.01.2017 450

Case No.:22/11/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00556/AM17/ RLA File :03/94/040/00262/AM17/ Lic.No/Date:0310806600 26.07.2016 Defer Date: 24.01.2017 451

Case No.:65/13/82-

ALC4/2016 Party Name:INDOCO REMEDIES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00693/AM17/ RLA File :03/94/040/00334/AM17/ Lic.No/Date:0310806610 26.07.2016 Defer Date: 24.01.2017 452

Case No.:62/13/82-

ALC4/2016 Party Name:IPCA LABORATORIES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00690/AM17/ RLA File :03/94/040/00333/AM17/ Lic.No/Date:0310806623 26.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/632/2015-PI(Norms) dated December 2015 453

Case No.:77/11/82-

ALC4/2016 Party Name:ASIATIC DRUGS &PHARMACEUTICALS PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Deferred HQ File :01/82/050/00611/AM17/ RLA File :05/23/040/00124/AM17/ Lic.No/Date:0510399240 27.07.2016 Defer Date: 24.01.2017 454

Case No.:78/11/82-

ALC4/2016 Party Name:ASIATIC DRUGS &PHARMACEUTICALS PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Deferred HQ File :01/82/050/00612/AM17/ RLA File :05/23/040/00123/AM17/ Lic.No/Date:0510399239 27.07.2016 Defer Date: 24.01.2017 455 Case No.:79/11/82- ALC4/2016 Party Name:ASIATIC DRUGS Meet No/Date:15/82- ALC4/2016 Status:Deferred

72 &PHARMACEUTICALS PVT. LTD. 15.12.2016 HQ File :01/82/050/00613/AM17/ RLA File :05/23/040/00119/AM17/ Lic.No/Date:0510399242 27.07.2016 Defer Date: 24.01.2017 456

Case No.:80/11/82-

ALC4/2016 Party Name:ASIATIC DRUGS &PHARMACEUTICALS PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00614/AM17/ RLA File :05/23/040/00125/AM17/ Lic.No/Date:0510399241 27.07.2016 Defer Date: 24.01.2017 457

Case No.:67/13/82-

ALC4/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00695/AM17/ RLA File :03/94/040/00335/AM17/ Lic.No/Date:0310806658 27.07.2016 Defer Date: 24.01.2017 458

Case No.:66/13/82-

ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00694/AM17/ RLA File :03/94/040/00332/AM17/ Lic.No/Date:0310806661 27.07.2016 Defer Date: its meeting No.22/82 dated 20.02.2014, uploaded at the end of these minutes or as applied by 459

Case No.:84/13/82-

ALC4/2016 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00712/AM17/ RLA File :05/24/040/00170/AM17/ Lic.No/Date:0510399250 27.07.2016 Defer Date: 24.01.2017 Decision :Deferred. 460

Case No.:64/13/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00692/AM17/ RLA File :03/94/040/00177/AM17/ Lic.No/Date:0310806697 28.07.2016 Defer Date: 24.01.2017 461

Case No.:71/13/82-

ALC4/2016 Party Name:CIRON DRUGS & PHARMACEUTICALS P. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File RLA File Lic.No/Date:0310806768 Defer Date:

73 :01/82/050/00699/AM17/ :03/94/040/00312/AM17/ 01.08.2016 24.01.2017 462

Case No.:70/13/82-

ALC4/2016 Party Name:INDOCO REMEDIES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00698/AM17/ RLA File :03/94/040/00344/AM17/ Lic.No/Date:0310806741 01.08.2016 Defer Date: 24.01.2017 463

Case No.:63/13/82-

ALC4/2016 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00691/AM17/ RLA File :03/94/040/00280/AM17/ Lic.No/Date:0310806745 01.08.2016 Defer Date: 24.01.2017 464

Case No.:57/13/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00685/AM17/ RLA File :03/95/040/00367/AM17/ Lic.No/Date:0310806759 01.08.2016 Defer Date: its meeting No.05/82 dated 04.05.2010, uploaded at the end of these minutes or as applied by the 465

Case No.:35/13/82-

ALC4/2016 Party Name:VENUS REMEDIES LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00663/AM17/ RLA File :22/24/040/00036/AM17/ Lic.No/Date:2210015529 02.08.2016 Defer Date: 24.01.2017 466

Case No.:34/13/82-

ALC4/2016 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00662/AM17/ RLA File :13/24/040/00017/AM17/ Lic.No/Date:1310048326 03.08.2016 Defer Date: 24.01.2017 467

Case No.:9/13/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00637/AM17/ RLA File :08/24/040/00175/AM17/ Lic.No/Date:0810138443 05.08.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/539/2013-PI(Norms) dated 26.09.2013 uploaded

74 468

Case No.:73/13/82-

ALC4/2016 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00701/AM17/ RLA File :03/94/040/00354/AM17/ Lic.No/Date:0310806872 05.08.2016 Defer Date: 24.01.2017 Decision : : Deferred for want of comments from DoP. 469

Case No.:74/13/82-

ALC4/2016 Party Name:ALIVIRA ANIMAL HEALTH LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00702/AM17/ RLA File :03/94/040/00367/AM17/ Lic.No/Date:0310806928 08.08.2016 Defer Date: 24.01.2017 Decision : : Deferred for want of comments from DBT. 470

Case No.:72/13/82-

ALC4/2016 Party Name:INVENTIA HEALTHCARE PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00700/AM17/ RLA File :03/94/040/00356/AM17/ Lic.No/Date:0310806927 08.08.2016 Defer Date: 24.01.2017 Decision : : Deferred for want of comments from DoP. 471

Case No.:59/13/82-

ALC4/2016 Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00687/AM17/ RLA File :03/95/040/00998/AM16/ Lic.No/Date:0310806923 08.08.2016 Defer Date: 24.01.2017 Decision :Deferred. 472

Case No.:49/13/82-

ALC4/2016 Party Name:ALTA LABORATORIES LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00677/AM17/ RLA File :03/94/040/01052/AM16/ Lic.No/Date:0310806947 09.08.2016 Defer Date: 24.01.2017 Decision : : Deferred for want of comments from DoP. 473

Case No.:50/13/82-

ALC4/2016 Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00678/AM17/ RLA File :03/94/040/00286/AM17/ Lic.No/Date:0310806966 09.08.2016 Defer Date: 24.01.2017 Decision :Deferred. 474

Case No.:10/13/82-

ALC4/2016 KABI ONCOLOGY LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00638/AM17/ RLA File :05/23/040/00229/AM17/ Lic.No/Date:0510399392 09.08.2016 Defer Date: 24.01.2017 Decision : : Deferred for want of comments from DoP.

75 475

Case No.:26/13/82-

ALC4/2016 Party Name:VIVIMED LABS ( ALATHUR) PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00654/AM17/ RLA File :04/24/040/00065/AM17/ Lic.No/Date:0410162171 09.08.2016 Defer Date: 24.01.2017 Decision :Deferred. 476

Case No.:8/13/82-

ALC4/2016 Party Name:AKTINOS HEALTHCARE PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00636/AM17/ RLA File :09/24/040/00232/AM17/ Lic.No/Date:0910064019 10.08.2016 Defer Date: 24.01.2017 477

Case No.:54/13/82-

ALC4/2016 ALLIED PRODUCTS LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00682/AM17/ RLA File :03/94/040/00405/AM17/ Lic.No/Date:0310807006 10.08.2016 Defer Date: its meeting No.19/82 dated 02.01.2014 uploaded at the end of these minutes, or as applied by the firm whichever is less under Para 4.07 of HBP. RA concerned may take further necessary action 478

Case No.:1/15/82-

ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00815/AM17/ RLA File :05/23/040/00226/AM17/ Lic.No/Date:0510399403 10.08.2016 Defer Date:24.01.2017 479

Case No.:58/13/82-

ALC4/2016 Party Name:SUNSHIELD CHEMICALS LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00686/AM17/ RLA File :03/95/040/00370/AM17/ Lic.No/Date:0310807000 10.08.2016 Defer Date: its meeting No.23/82 dated 01.11.2012, uploaded at the end of these minutes or as applied by the 480

Case No.:41/13/82-

ALC4/2016 Party Name:VIRDEV INTERMEDIATES PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00669/AM17/ RLA File :52/24/040/00031/AM17/ Lic.No/Date:5210041993 10.08.2016 Defer Date: 24.01.2017 481

Case No.:47/13/82-

ALC4/2016 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved

76 HQ File :01/82/050/00675/AM17/ RLA File :03/94/040/00414/AM17/ Lic.No/Date:0310807048 11.08.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/739/2015-PI(Norms) dated 23.02.2016 uploaded 482

Case No.:17/13/82-

ALC4/2016 Party Name:HELLO PAINTS (P) LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00645/AM17/ RLA File :05/23/040/00220/AM17/ Lic.No/Date:0510399449 11.08.2016 Defer Date: 24.01.2017 Decision : Deferred . 483

Case No.:76/13/82-

ALC4/2016 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00704/AM17/ RLA File :03/94/040/00391/AM17/ Lic.No/Date:0310807030 11.08.2016 Defer Date: 24.01.2017 Decision :Deferred 484

Case No.:18/13/82-

ALC4/2016 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00646/AM17/ RLA File :05/23/040/00230/AM17/ Lic.No/Date:0510399442 11.08.2016 Defer Date: 24.01.2017 Decision :Deferred. 485

Case No.:61/13/82-

ALC4/2016 Party Name:S M B CORPORATION OF INDIA Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00689/AM17/ RLA File :03/95/040/00388/AM17/ Lic.No/Date:0310807070 11.08.2016 Defer Date: 24.01.2017 Decision :Deferred. 486

Case No.:78/13/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00706/AM17/ RLA File :03/94/040/00371/AM17/ Lic.No/Date:0310807104 12.08.2016 Defer Date: 24.01.2017 Decision :Deferred. 487

Case No.:12/13/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00640/AM17/ RLA File :08/24/040/00196/AM17/ Lic.No/Date:0810138482 12.08.2016 Defer Date: 24.01.2017 488 Case No.:154/13/82- ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:15/82- ALC4/2016 Status: Approved

77 15.12.2016 HQ File :01/82/050/00782/AM17/ RLA File :05/24/040/00231/AM17/ Lic.No/Date:0510399455 12.08.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/201/2016-PI(Norms) dated August 2016 489

Case No.:15/13/82-

ALC4/2016 Party Name:TORRENT PHARMACEUTICALS LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00643/AM17/ RLA File :08/24/040/00184/AM17/ Lic.No/Date:0810138477 12.08.2016 Defer Date: 24.01.2017 490

Case No.:53/13/82-

ALC4/2016 Party Name:CORAL LABORATORIES LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00681/AM17/ RLA File :03/94/040/00421/AM17/ Lic.No/Date:0310807134 16.08.2016 Defer Date: 24.01.2017 491

Case No.:14/13/82-

ALC4/2016 Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00642/AM17/ RLA File :08/24/040/00181/AM17/ Lic.No/Date:0810138489 16.08.2016 Defer Date: 24.01.2017 Decision :Deferred. 492

Case No.:16/13/82-

ALC4/2016 Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00644/AM17/ RLA File :08/24/040/00191/AM17/ Lic.No/Date:0810138490 16.08.2016 Defer Date: 24.01.2017 Decision :Deferred. 493

Case No.:140/13/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00768/AM17/ RLA File :05/24/040/00181/AM17/ Lic.No/Date:0510399463 16.08.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/810/2015-PI(Norms) dated 07.06.2016 uploaded 494

Case No.:51/13/82-

ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00679/AM17/ RLA File :03/94/040/00359/AM17/ Lic.No/Date:0310807160 17.08.2016 Defer Date:

78 its meeting No.1/82 dated 10.04.2014, uploaded at the end of these minutes or as applied by the 495

Case No.:11/13/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00639/AM17/ RLA File :08/24/040/00190/AM17/ Lic.No/Date:0810138500 17.08.2016 Defer Date: 24.01.2017 496

Case No.:33/13/82-

ALC4/2016 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00661/AM17/ RLA File :22/24/040/00044/AM17/ Lic.No/Date:2210015545 17.08.2016 Defer Date: 24.01.2017 497

Case No.:52/13/82-

ALC4/2016 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00680/AM17/ RLA File :03/94/040/00160/AM17/ Lic.No/Date:0310807167 17.08.2016 Defer Date: 24.01.2017 Decision :Deferred. 498

Case No.:40/13/82-

ALC4/2016 Party Name:AETHER INDUSTRIES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00668/AM17/ RLA File :52/24/040/00036/AM17/ Lic.No/Date:5210042006 19.08.2016 Defer Date: 24.01.2017 Decision :Deferred. 499

Case No.:19/13/82-

ALC4/2016 KABI ONCOLOGY LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00647/AM17/ RLA File :05/23/040/00234/AM17/ Lic.No/Date:0510399492 19.08.2016 Defer Date: 24.01.2017 500

Case No.:142/13/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00770/AM17/ RLA File :05/24/040/00226/AM17/ Lic.No/Date:0510399509 19.08.2016 Defer Date: 24.01.2017 501

Case No.:150/13/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File RLA File Lic.No/Date:0510399507 Defer Date:

79 :01/82/050/00778/AM17/ :05/24/040/00201/AM17/ 19.08.2016 24.01.2017 502

Case No.:151/13/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00779/AM17/ RLA File :05/24/040/00227/AM17/ Lic.No/Date:0510399510 19.08.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/141/2016-PI(Norms) dated July 2016 uploaded at the end of these minutes, or as applied by the firm whichever is less under Para 4.07 of HBP. RA concerned may take further necessary action as per decision of NC. 503

Case No.:152/13/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00780/AM17/ RLA File :05/24/040/00200/AM17/ Lic.No/Date:0510399505 19.08.2016 Defer Date: 24.01.2017 504

Case No.:56/13/82-

ALC4/2016 Party Name:IPCA LABORATORIES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00684/AM17/ RLA File :03/94/040/00444/AM17/ Lic.No/Date:0310807298 22.08.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/121/2016-PI(Norms) dated July 2016 uploaded at the end of these minutes, or as applied by the firm whichever is less under Para 4.07 of HBP. RA concerned may take further necessary action as per decision of NC. 505

Case No.:69/13/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00697/AM17/ RLA File :03/94/040/00339/AM17/ Lic.No/Date:0310807289 22.08.2016 Defer Date: 24.01.2017 506

Case No.:158/13/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00786/AM17/ RLA File :05/23/040/00242/AM17/ Lic.No/Date:0510399523 22.08.2016 Defer Date: 24.01.2017 507

Case No.:112/13/82-

ALC4/2016 Party Name:AIMS IMPEX PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00740/AM17/ RLA File :03/94/040/00436/AM17/ Lic.No/Date:0310807309 23.08.2016 Defer Date: 24.01.2017 Decision :Deferred.

80 508

Case No.:68/13/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00696/AM17/ RLA File :03/94/040/00453/AM17/ Lic.No/Date:0310807316 23.08.2016 Defer Date: 24.01.2017 509

Case No.:156/13/82-

ALC4/2016 Party Name:MAHIMA LIFE SCIENCES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00784/AM17/ RLA File :05/24/040/00214/AM17/ Lic.No/Date:0510399536 23.08.2016 Defer Date: 24.01.2017 510

Case No.:157/13/82-

ALC4/2016 Party Name:MAHIMA LIFE SCIENCES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00785/AM17/ RLA File :05/24/040/00215/AM17/ Lic.No/Date:0510399537 23.08.2016 Defer Date: 24.01.2017 511

Case No.:141/13/82-

ALC4/2016 Party Name:RHYDBURG PHARMACEUTICALS LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00769/AM17/ RLA File :05/24/040/00239/AM17/ Lic.No/Date:0510399535 23.08.2016 Defer Date: 24.01.2017 512

Case No.:75/13/82-

ALC4/2016 Party Name:ANUH PHARMA LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00703/AM17/ RLA File :03/94/040/00456/AM17/ Lic.No/Date:0310807339 24.08.2016 Defer Date: 24.01.2017 Decision : 513

Case No.:55/13/82-

ALC4/2016 Party Name:CORAL LABORATORIES LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: approved HQ File :01/82/050/00683/AM17/ RLA File :03/94/040/00441/AM17/ Lic.No/Date:0310807355 24.08.2016 Defer Date: Decision :The Committee decided to ratify norms as per SION A-648 published earlier vide PN No.64/2015-2020 dated 17.03.2016. RA concerned may calculate quantity on pro-rata basis as per decision of NC. 514

Case No.:60/13/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00688/AM17/ RLA File :03/95/040/00434/AM17/ Lic.No/Date:0310807413 26.08.2016 Defer Date:

81 its meeting No.07/82 dated 18.05.2010, uploaded at the end of these minutes or as applied by the 515

Case No.:21/13/82-

ALC4/2016 Party Name:BALAJI AMINES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: approved HQ File :01/82/050/00649/AM17/ RLA File :31/83/040/00045/AM17/ Lic.No/Date:3110066311 29.08.2016 Defer Date: Decision : The Committee decided to ratify norms based on the earlier recommendation given by D/o C&PC vide U.O.No.14010/122/2011-Ch-II dated 11.02.2016 uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 516

Case No.:22/13/82-

ALC4/2016 Party Name:BALAJI AMINES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: approved HQ File :01/82/050/00650/AM17/ RLA File :31/83/040/00044/AM17/ Lic.No/Date:3110066310 29.08.2016 Defer Date: Decision : The Committee decided to ratify norms based on the earlier recommendation given by D/o C&PC vide U.O.No.14010/122/2011-Ch-II dated 11.02.2016 uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 517

Case No.:23/13/82-

ALC4/2016 Party Name:BALAJI AMINES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: approved HQ File :01/82/050/00651/AM17/ RLA File :31/83/040/00042/AM17/ Lic.No/Date:3110066309 29.08.2016 Defer Date: Decision : The Committee decided to ratify norms based on the earlier recommendation given by D/o C&PC vide U.O.No.14010/122/2011-Ch-II dated 26.02.2016 uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 518

Case No.:94/13/82-

ALC4/2016 Party Name:BODAL CHEMICALS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00722/AM17/ RLA File :08/24/040/00137/AM17/ Lic.No/Date:0810138556 29.08.2016 Defer Date: 24.01.2017 519

Case No.:160/13/82-

ALC4/2016 KABI ONCOLOGY LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00788/AM17/ RLA File :05/23/040/00252/AM17/ Lic.No/Date:0510399569 29.08.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/171/2016-PI(Norms) dated 28.12.2016 uploaded

82 520

Case No.:161/13/82-

ALC4/2016 KABI ONCOLOGY LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00789/AM17/ RLA File :05/23/040/00251/AM17/ Lic.No/Date:0510399568 29.08.2016 Defer Date: 24.01.2017 521

Case No.:123/13/82-

ALC4/2016 Party Name:D. R. COATS INK & RESINS PVT. LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00751/AM17/ RLA File :03/94/040/00265/AM17/ Lic.No/Date:0310807443 30.08.2016 Defer Date: 24.01.2017 Decision :Deferred. 522

Case No.:81/13/82-

ALC4/2016 Party Name:PANACEA BIOTEC LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00709/AM17/ RLA File :05/24/040/00258/AM17/ Lic.No/Date:0510399580 30.08.2016 Defer Date: 24.01.2017 Decision : Deferred for want of comments from DBT. 523

Case No.:133/13/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00761/AM17/ RLA File :03/95/040/00239/AM17/ Lic.No/Date:0310807508 31.08.2016 Defer Date: 24.01.2017 Decision :Deferred. 524

Case No.:134/13/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00762/AM17/ RLA File :03/95/040/00249/AM17/ Lic.No/Date:0310807509 31.08.2016 Defer Date: 24.01.2017 Decision :Deferred. 525

Case No.:132/13/82-

ALC4/2016 Party Name:ZIM LABORATORIES LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00760/AM17/ RLA File :03/95/040/00448/AM17/ Lic.No/Date:0310807505 31.08.2016 Defer Date: 24.01.2017 Decision :Deferred. 526

Case No.:110/13/82-

ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00738/AM17/ RLA File :03/94/040/00415/AM17/ Lic.No/Date:0310807546 01.09.2016 Defer Date: its meeting No.18/82 dated 19.12.2013, uploaded at the end of these minutes or as applied by

83 527

Case No.:111/13/82-

ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00739/AM17/ RLA File :03/94/040/00473/AM17/ Lic.No/Date:0310807547 01.09.2016 Defer Date: its meeting No.18/82 dated 19.12.2013, uploaded at the end of these minutes or as applied by 528

Case No.:120/13/82-

ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00748/AM17/ RLA File :03/94/040/00390/AM17/ Lic.No/Date:0310807543 01.09.2016 Defer Date: its meeting No.18/82 dated 19.12.2013, uploaded at the end of these minutes or as applied by 529

Case No.:124/13/82-

ALC4/2016 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00752/AM17/ RLA File :03/94/040/00464/AM17/ Lic.No/Date:0310807534 01.09.2016 Defer Date: 24.01.2017 Decision :Deferred. 530

Case No.:121/13/82-

ALC4/2016 Party Name:GOPALDAS VISRAM & CO.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00749/AM17/ RLA File :03/94/040/00469/AM17/ Lic.No/Date:0310807553 01.09.2016 Defer Date: 24.01.2017 Decision :Deferred. 531

Case No.:163/13/82-

ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00791/AM17/ RLA File :09/24/040/00285/AM17/ Lic.No/Date:0910064084 01.09.2016 Defer Date: 24.01.2017 532

Case No.:164/13/82-

ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00792/AM17/ RLA File :09/24/040/00311/AM17/ Lic.No/Date:0910064091 01.09.2016 Defer Date: 24.01.2017 533 Case No.:168/13/82- ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date:15/82- ALC4/2016 Status:Deferred

84 15.12.2016 HQ File :01/82/050/00796/AM17/ RLA File :09/24/040/00301/AM17/ Lic.No/Date:0910064085 01.09.2016 Defer Date: 24.01.2017 534

Case No.:170/13/82-

ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00798/AM17/ RLA File :09/24/040/00284/AM17/ Lic.No/Date:0910064083 01.09.2016 Defer Date: 24.01.2017 535

Case No.:95/13/82-

ALC4/2016 Party Name:ACULIFE HEALTHCARE PRIVATE LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00723/AM17/ RLA File :08/24/040/00161/AM17/ Lic.No/Date:0810138597 02.09.2016 Defer Date: 24.01.2017 536

Case No.:143/13/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00771/AM17/ RLA File :08/24/040/00124/AM17/ Lic.No/Date:0810138603 02.09.2016 Defer Date: 24.01.2017 537

Case No.:146/13/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00774/AM17/ RLA File :22/24/040/00046/AM17/ Lic.No/Date:2210015557 02.09.2016 Defer Date: 24.01.2017 538

Case No.:147/13/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00775/AM17/ RLA File :22/24/040/00047/AM17/ Lic.No/Date:2210015556 02.09.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/82/2016-PI(Norms) dated 20.12.2016, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take necessary action as per decision of NC. 539

Case No.:122/13/82-

ALC4/2016 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00750/AM17/ RLA File :03/94/040/00374/AM17/ Lic.No/Date:0310807578 02.09.2016 Defer Date: 24.01.2017 Decision :Deferred.

85 540

Case No.:145/13/82-

ALC4/2016 Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00773/AM17/ RLA File :22/24/040/00049/AM17/ Lic.No/Date:2210015554 02.09.2016 Defer Date: 24.01.2017 541

Case No.:109/13/82-

ALC4/2016 Party Name:AURA PHARMACEUTICALS PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00737/AM17/ RLA File :03/94/040/00484/AM17/ Lic.No/Date:0310807613 06.09.2016 Defer Date: 24.01.2017 542

Case No.:79/13/82-

ALC4/2016 Party Name:BALAJI AMINES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: approved HQ File :01/82/050/00707/AM17/ RLA File :31/83/040/00070/AM17/ Lic.No/Date:3110066330 07.09.2016 Defer Date: Decision : The Committee decided to ratify norms based on the earlier recommendation given by D/o C&PC vide U.O.No.14010/122/2011-Ch-II dated 26.02.2016 uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 543

Case No.:131/13/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00759/AM17/ RLA File :03/95/040/00248/AM17/ Lic.No/Date:0310807651 07.09.2016 Defer Date: 24.01.2017 Decision :Deferred. 544

Case No.:135/13/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00763/AM17/ RLA File :03/95/040/00247/AM17/ Lic.No/Date:0310807650 07.09.2016 Defer Date: 24.01.2017 Decision :Deferred. 545

Case No.:136/13/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00764/AM17/ RLA File :03/95/040/00311/AM17/ Lic.No/Date:0310807649 07.09.2016 Defer Date: 24.01.2017 Decision :Deferred. 546

Case No.:130/13/82-

ALC4/2016 Party Name:UNIMAX LABORATORIES PVT.LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00758/AM17/ RLA File :03/95/040/00438/AM17/ Lic.No/Date:0310807648 07.09.2016 Defer Date:

86 Pharmaceuticals forwarded vide O.M.No.35011/10/2016-PI(Norms) dated 07.06.2016 uploaded at the end of these minutes, or as applied by the firm whichever is less under Para 4.07 of HBP. RA concerned may take further necessary action as per decision of NC. 547

Case No.:138/13/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00766/AM17/ RLA File :03/95/040/00467/AM17/ Lic.No/Date:0310807656 07.09.2016 Defer Date: its meeting No.07/82 dated 18.05.2010, uploaded at the end of these minutes or as applied by the 548

Case No.:167/13/82-

ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00795/AM17/ RLA File :09/24/040/00300/AM17/ Lic.No/Date:0910064112 08.09.2016 Defer Date: 24.01.2017 549

Case No.:169/13/82-

ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00797/AM17/ RLA File :09/24/040/00302/AM17/ Lic.No/Date:0910064113 08.09.2016 Defer Date: 24.01.2017 550

Case No.:108/13/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00736/AM17/ RLA File :03/94/040/00506/AM17/ Lic.No/Date:0310807686 08.09.2016 Defer Date: 24.01.2017 551

Case No.:137/13/82-

ALC4/2016 Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00765/AM17/ RLA File :03/95/040/00437/AM17/ Lic.No/Date:0310807709 08.09.2016 Defer Date: 24.01.2017 Decision :Deferred. 552

Case No.:159/13/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00787/AM17/ RLA File :05/24/040/00264/AM17/ Lic.No/Date:0510399649 08.09.2016 Defer Date: 24.01.2017

87 553

Case No.:98/13/82-

ALC4/2016 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00726/AM17/ RLA File :08/24/040/00235/AM17/ Lic.No/Date:0810138637 09.09.2016 Defer Date: 24.01.2017 554

Case No.:162/13/82-

ALC4/2016 Party Name:HETERO DRUGS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00790/AM17/ RLA File :09/24/040/00309/AM17/ Lic.No/Date:0910064122 09.09.2016 Defer Date: 24.01.2017 555

Case No.:166/13/82-

ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00794/AM17/ RLA File :09/24/040/00314/AM17/ Lic.No/Date:0910064123 09.09.2016 Defer Date: 24.01.2017 556

Case No.:165/13/82-

ALC4/2016 Party Name:HONOUR LAB LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00793/AM17/ RLA File :09/24/040/00321/AM17/ Lic.No/Date:0910064126 09.09.2016 Defer Date: 24.01.2017 557

Case No.:106/13/82-

ALC4/2016 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00734/AM17/ RLA File :03/94/040/00538/AM17/ Lic.No/Date:0310807771 14.09.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/66/2015-PI(Norms) dated Sept. 2015 uploaded at the end of these minutes, or as applied by the firm whichever is less under Para 4.07 of HBP. RA concerned may take further necessary action as per decision of NC. 558

Case No.:148/13/82-

ALC4/2016 Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00776/AM17/ RLA File :22/24/040/00055/AM17/ Lic.No/Date:2210015561 14.09.2016 Defer Date: Decision : The Committee decided to ratify norms based on SION A-3647. RA concerned may calculate quantity on pro-rata basis as per decision of NC. 559

Case No.:104/13/82-

ALC4/2016 Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00732/AM17/ RLA File :03/94/040/00468/AM17/ Lic.No/Date:0310807804 15.09.2016 Defer Date:

88 its meeting No.04/82 dated 16.05.2013, uploaded at the end of these minutes or as applied by the 560

Case No.:93/13/82-

ALC4/2016 Party Name:MAHIMA LIFE SCIENCES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00721/AM17/ RLA File :05/24/040/00217/AM17/ Lic.No/Date:0510399726 15.09.2016 Defer Date: 24.01.2017 561

Case No.:105/13/82-

ALC4/2016 Party Name:AARTI DRUGS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00733/AM17/ RLA File :03/94/040/00487/AM17/ Lic.No/Date:0310807836 16.09.2016 Defer Date: 24.01.2017 562

Case No.:102/13/82-

ALC4/2016 ALLIED PRODUCTS LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00730/AM17/ RLA File :03/94/040/00544/AM17/ Lic.No/Date:0310807851 16.09.2016 Defer Date: its meeting No.19/82 dated 02.01.2014, uploaded at the end of these minutes or as applied by the 563

Case No.:107/13/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00735/AM17/ RLA File :03/94/040/00540/AM17/ Lic.No/Date:0310807829 16.09.2016 Defer Date: 24.01.2017 564

Case No.:46/13/82-

ALC4/2016 Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00674/AM17/ RLA File :08/24/040/00215/AM17/ Lic.No/Date:0810138683 16.09.2016 Defer Date: 24.01.2017 Decision :Deferred. 565

Case No.:153/13/82-

ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00781/AM17/ RLA File :05/23/040/00265/AM17/ Lic.No/Date:0510399737 16.09.2016 Defer Date: 24.01.2017 566 Case No.:155/13/82- Party Name:JODAS Meet No/Date:15/82- Status:Deferred

89 ALC4/2016 EXPOIM PVT.LTD., ALC4/2016 15.12.2016 HQ File :01/82/050/00783/AM17/ RLA File :05/23/040/00264/AM17/ Lic.No/Date:0510399736 16.09.2016 Defer Date: 24.01.2017 567

Case No.:129/13/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00757/AM17/ RLA File :03/95/040/00313/AM17/ Lic.No/Date:0310807812 16.09.2016 Defer Date: 24.01.2017 Decision :Deferred. 568

Case No.:42/13/82-

ALC4/2016 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00670/AM17/ RLA File :34/24/040/00174/AM17/ Lic.No/Date:3410042536 20.09.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/104/2015-PI(Norms) dated Sept.2015 uploaded 569

Case No.:103/13/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00731/AM17/ RLA File :03/94/040/00516/AM17/ Lic.No/Date:0310807914 20.09.2016 Defer Date: 24.01.2017 570

Case No.:43/13/82-

ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00671/AM17/ RLA File :09/24/040/00303/AM17/ Lic.No/Date:0910064168 21.09.2016 Defer Date: 24.01.2017 571

Case No.:101/13/82-

ALC4/2016 Party Name:GALAXY SURFACTANTS LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: approved HQ File :01/82/050/00729/AM17/ RLA File :03/94/040/00552/AM17/ Lic.No/Date:0310807954 21.09.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded earlier vide U.O.No.14010/148/2011-Ch-II dated 30.09.2015, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 572

Case No.:119/13/82-

ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Deferred

90 HQ File :01/82/050/00747/AM17/ RLA File :07/24/040/00207/AM17/ Lic.No/Date:0710110442 21.09.2016 Defer Date:24.01.2017 573

Case No.:149/13/82-

ALC4/2016 Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00777/AM17/ RLA File :22/24/040/00058/AM17/ Lic.No/Date:2210015566 21.09.2016 Defer Date: Decision :The Committee decided to ratify norms as per SION A-3648. RA concerned may calculate quantity on prorate basis as per decision of NC. 574

Case No.:45/13/82-

ALC4/2016 Party Name:BIO TECH OPHTHALMICS PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00673/AM17/ RLA File :08/24/040/00216/AM17/ Lic.No/Date:0810138715 22.09.2016 Defer Date: 24.01.2017 575

Case No.:91/13/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00719/AM17/ RLA File :08/24/040/00242/AM17/ Lic.No/Date:0810138723 22.09.2016 Defer Date: 24.01.2017 576

Case No.:92/13/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00720/AM17/ RLA File :08/24/040/00243/AM17/ Lic.No/Date:0810138725 22.09.2016 Defer Date: 24.01.2017 577

Case No.:100/13/82-

ALC4/2016 Party Name:K V AROCHEM PVT. LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00728/AM17/ RLA File :03/94/040/00525/AM17/ Lic.No/Date:0310807975 22.09.2016 Defer Date: 24.01.2017 Decision :Deferred. 578

Case No.:82/13/82-

ALC4/2016 Party Name:VERTELLUS SPECIALTY MATERIALS (INDIA) PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00710/AM17/ RLA File :52/24/040/00040/AM17/ Lic.No/Date:5210042029 22.09.2016 Defer Date: 24.01.2017 Decision :Deferred. 579 Case No.:127/13/82- ALC4/2016 Party Name:SUPRIYA LIFESCIENCE LTD Meet No/Date:15/82- ALC4/2016 Status: Approved

91 15.12.2016 HQ File :01/82/050/00755/AM17/ RLA File :03/95/040/00504/AM17/ Lic.No/Date:0310808030 23.09.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/237/2016-PI(Norms) dated October 2016 580

Case No.:113/13/82-

ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00741/AM17/ RLA File :09/24/040/00342/AM17/ Lic.No/Date:0910064191 27.09.2016 Defer Date: 24.01.2017 581

Case No.:114/13/82-

ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00742/AM17/ RLA File :09/24/040/00341/AM17/ Lic.No/Date:0910064192 27.09.2016 Defer Date: 24.01.2017 582

Case No.:139/13/82-

ALC4/2016 Party Name:VISWAAT CHEMICALS LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00767/AM17/ RLA File :03/95/040/00302/AM17/ Lic.No/Date:0310808110 27.09.2016 Defer Date: 24.01.2017 Decision :Deferred. 583

Case No.:99/13/82-

ALC4/2016 Party Name:ATUL LIMITED, Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00727/AM17/ RLA File :08/24/040/00214/AM17/ Lic.No/Date:0810138766 29.09.2016 Defer Date: 24.01.2017 Decision :Deferred. 584

Case No.:90/13/82-

ALC4/2016 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00718/AM17/ RLA File :52/24/040/00042/AM17/ Lic.No/Date:5210042032 30.09.2016 Defer Date: 24.01.2017 Decision :Deferred. 585

Case No.:125/13/82-

ALC4/2016 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00753/AM17/ RLA File :03/95/040/00490/AM17/ Lic.No/Date:0310808208 30.09.2016 Defer Date: 24.01.2017 Decision :Deferred.

92 586

Case No.:126/13/82-

ALC4/2016 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00754/AM17/ RLA File :03/95/040/00410/AM17/ Lic.No/Date:0310808209 30.09.2016 Defer Date: 24.01.2017 Decision :Deferred. 587

Case No.:96/13/82-

ALC4/2016 Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00724/AM17/ RLA File :31/83/040/00090/AM17/ Lic.No/Date:3110066356 07.10.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/3/2012-Ch-II (Vol.-I) dated 16.02.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 588

Case No.:86/13/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00714/AM17/ RLA File :05/24/040/00320/AM17/ Lic.No/Date:0510400111 17.10.2016 Defer Date: 24.01.2017 589

Case No.:88/13/82-

ALC4/2016 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status: Approved HQ File :01/82/050/00716/AM17/ RLA File :34/24/040/00194/AM17/ Lic.No/Date:3410042597 19.10.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/304/2015-PI(Norms) dated October 2015 590

Case No.:87/13/82-

ALC4/2016 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:
Approved HQ File :01/82/050/00715/AM17/ RLA File :09/24/040/00238/AM17/ Lic.No/Date:0910064273 19.10.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/423/2015-PI(Norms) dated October 2015 591

Case No.:2/15/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:15/82- ALC4/2016 15.12.2016 Status:Deferred HQ File :01/82/050/00816/AM17/ RLA File :03/95/040/00449/AM17/ Lic.No/Date:0310809088 10.11.2016 Defer Date:24.01.2017 Decision :Deferred.

93 Manual Agenda of NC Meeting No. 15/82 Scheduled to be held on 15.12.2016 but actually held on 29.12.2016

Case No. B- 01

M.No.15/AM-17 Date 15.12.2016 RLA No 03/94/040/00205/AM15 RLA No 03/94/040/00133/AM15 RLA No 03/94/040/00111/AM15 M/s. Indoco Remedies Ltd File No. 01/82/050/00769/AM15 File No. 01/82/050/00778/AM15 File No. 01/82/050/00784/AM15 Adv.Auth. No. 0310785225 dated 12.06.2014 Adv.Auth. No. 0310782942 dated 26.05.2014 Adv.Auth. No. 0310782171 dated 20.05.2014 Decision: The Committee considered this for revision of Norms as per agenda. The Committee decided to revise norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/606/2015-PI(Norms) dated 29.08.2016, uploaded at the end of these minutes. RA concerned may take further necessary action as per decision of NC.

Case No. B- 02

M.No.15/AM-17 Date 15.12.2016 M/s. Encube Ethicals Pvt Ltd File No. 01/82/050/00566/AM16 RLA No 03/94/040/01162/AM15 Adv.Auth. No. 0310794710 dated 19.03.2015 Decision: The Committee considered this case for correction in the description of export product as per agenda. The Committee noted that all the formulations are indicated along with composition of the formulation i.e. content of API. The Committee accordingly decided to maintain status quo.

Case No. B- 03

M.No.15/AM-17 Date 15.12.2016 M/s. Yasho Industries Pvt Ltd File No. 01/82/050/00260/AM16 RLA No 03/95/040/00820/AM15 Adv.Auth. No. 0310792428 dated 29.12.2014 Decision: The Committee considered this for fixation of Norms as per agenda. The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/95/2011-Ch-II dated 11.09.2015, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per decision of NC.

Case No. B- 04

M.No.15/AM-17 Date 15.12.2016 M/s. Yasho Industries Pvt Ltd File No. 01/82/050/01064/AM14 RLA No 03/95/040/00705/AM14 Adv.Auth. No. 0310760774 dated 05.12.2013 Decision: The Committee considered this for correction in description of import item from “Clove Leaf Oil (Eugenol Content 78%) as recommended by D/o C&PC to “Clove Leaf Oil” as applied by the firm as per agenda.
The Committee decided to send this case to MSME for their comments. The Committee accordingly deferred the case.

Case No. B- 05

M.No.15/AM-17 Date 15.12.2016 M/s PI Industries Pvt Ltd File No. 01/82/050/818/AM15 RLA No 13/24/040/0020/AM15

94 Adv.Auth. No.1310047575 dated 12.08.2014 Decision: The Committee considered this case for correction/amendment in the description of import No.1 from “2 Chloro-4-Fluoro Toluene” as recommended by D/o C&PC vide U.O.No.15022/6/2010-Ch-II dated 10.08.2016
to “2-Chloro-4-Fluoro-5- Nitrobenzotrichloride”as applied by firm per agenda. The Committee decided to amend the description of import item No.1 to read as “2-Chloro-4- Fluoro-5-Nitrobenzotrichloride”as applied by the firm without any other change. RA concerned may take further necessary action as per decision of NC.

---

(TO be published in the Gazete oflndia Extraordinary) 5'多 S Sk′Sワζ (Part:‐ Section l) Government of:ndia Ministry of Corn『nerce and lndustry Department of Commerce Directorate General of Foreign Trade Public Notice No.64′ 2015Ⅲ2020 New De:hi:Dated 17th March,2016 Subi― Standard lnput Output Norms under Chemical&A‖ ied Product Group― reg. ln exercise ofthe powers conferred under Paragraph 2.04 ofthe Forё ign Trade Policy, 2015-2020 and Paragraph l.01 0f Handbook of Procedures(VOI。 |),the Directorate General of Foreign Trade hereby notifies Standard lnput Output Norms bearing numbers A‐ 3645, A‐ 3646,A… 3647A-3648,A‐ 3649,A‐3650,A-3651,A-3652,A-3653,A‐ 3654,A‐3655,A-3656,A… 3657,A― 3658,A-3659,A-3660,A‐ 3661,A-3662,A‐ 3663,A-3664,A‐ 3665,A-3666,A‐ 3667,A-3668,A‐ 3669,A― 3670,A-3671,A-3672,A-3673,A-3674,A‐ 3675,A‐3676 and A-3677 for export products the deta‖s of which are as given be10w. ヲ S10N SI No Description of Export ltem Export Quantity lmport ltems Quantity allowed 1 0 (3) (4) (6) A… 3645 Alendronate Sodium Tablets 70 mg (Each Tablet contains Alendronate Sodium equivalent to 70 mg Alendronic acid) 1000 Tab!ets Alendronate Sodium Trihydrate 93.152 gm A‐ 3646 Amikacinsutp@ (Each 2 ml vial contains Amikacin Sulphate equivalent to Amikacin 500 mq) 1000 via:s Amikacin Sulphate 715.81 gm A‐ 3647 Amoxicillin and potassium ClavunaG-.,l000 mg Tablets (Each lablet contains Amoxicillin Trihydrate equivalent to Amoxicillin 975 mg and Potassium Clavulanate equivalent to Clavulanic acid 125 mg) 1000 Tablets

1. Amoxicil‖ n THhydrate 1024238 gm

2.    Diluted
   

C!avulanate Potassium(1:1) 303773 9m A‐ 3648 Amoxicillin & ClavulaniC Ecid suspensbn 228.5m915 ml in 100 ml botfles. (Each 5 ml contains Amoxicillin Trihydrate equivalent to Amoxicillin 2OO mg and Potassium Clavulanate equivalent to Clavulanic acid 28.5 mg) 1000 bottles l Arnoxicillin Trihydrate 42009m 2. Diluted Clavulanate Potassium (1:1) 1414193 9m A‐ 3649 Ampicittin ano@ injection (each vial contains Rm[icittin Sodium equivalent to Ampicillin 500 mg and Sulbactam Sodium equivalent to Salbjctam 250 mg) 1000 via!s

1. Ampicillin Sodium 583.77 gm

Sulbactam Sodium 302.22 gm A…3650 Ampicillin injection S0O mg (each vial contains Ampicillin Sodium equivalent to Ampicillin 500 mg) ‐ ０ 。 Ｏ ｖｉ ａ ‐ ｓ Ampici‖ in Sodium 583.77 gm A‐3651 Atorvastatin@ contains Atorvastatin Calcium Trihydrate equivalent to 10 mg Atorvastatin) 1000 Tablets AtoⅣastatin Calc!iumTrlhydrate 11.0599m A‐3652 Benzylpeniciilin tnlection-5TE6-unG-6OO mS) {each vial contains Benzylpencillin Sodium equivalent to Benzylpeniiilin SOO ms) 1000 via:s Benzylpenicillin Sodium 35.171 gm

A‐ 3653 Cefadroxil (250 mS) and Potassium Clavulanate (62.5 mg) Dispersible Tablets {each tablet contains cefadroxil monohydrate equivalent to 250 mg Cefadroxil on Anhydrous basis and Clavulanate potassium equivalent to Clavulanic acid 62.5 mg) 1000 Tab!ets 1) Cefadroxil monohydrate 267.622 gm 2) Potassium Clavulanate 75.943 gm A‐ 3654 Cefixime for oral suspension 30 ml bottle (each 5 ml contains Cefixime Trihydrate equivalent to Cefixime 50 mg on anhydrous basis) 1000 bottles CefiximeTrihydrate 352508 9m A‐ 3655 Cefixime Tablets 200 mg (each tablet contains Cefixime Tridhydrate equivalent to Cefixime 200 mq on anhydrous basis) 1000 Tab Cefixime Trihydrate 228.294 gm A‐3656 Cefpodoxime Proxetil Tablets 200 mg (each tablet contains Cefpodoxime Proxetil equivalent to Cefpodoxime 200 mg) 1000 tab:ets Cefpodoxime Proxetil 266 10 gm A‐3657 Ceftriaxone and Sulbactam for injection. 1.5 gm (each vial containing Ceftriaxone Sodium equivalent to Ceftriaxone 1 gm and 1000 vials 1) Ceftrixone Sodium sterile As per S10N A― 407 Salbactam Sodium equivalent to Salbactam 0.50 sm) 2) Sulbactam Sodium sterile 604.44 gm A‐3658 Cefuroxime Axetil Tablets 500 mg (each tablet contains Cefuroxime Axetil equivalent to Cefuroxime 500 mo) 1000 Tab Cefuroxime Axetil 614.878 gm A‐ 3659 Cefuroxime for injection 750 mg (Each vial contains Cefuroxime Sodium equivalent to Cefuroxime 750 mq) 1000 vials Cefuroxime Sodium 867.74 gm A‐3660 Cefuroxime for oral suspension 125 mg/ 5 ml in 60 ml bottles {each 5 ml containing Cefuroxime Axetil equivalent to Cefuroxime 125 mo) 1000 botties Cefuroxime Axetil 1899 gm A…3661 Citicoline lnjection 250 mg /ml (each vial contains Citicoline Sodium equivalent to Citicoline 250 mq) Ｏ 　 ｓ ‐ ０ ０ ｖｉ ａ ‐ Clicoline Sodium 287.39 gm A‐ 3662 Citicoline Capsules 500 mg (each capsule contains citicoline sodium equivalent to Citicoline 500 mq) 1000 capsuies Citicoline sodium 532950 gm A‐3663 Clopidogrel Tablets 75 mg (each tablet contains Clopidogrel Bisulphate equivalent to Clopidoqrel 75 mq) 1000 Tablets Clopidogrel Bisulphate 99.814 gm A‐ 3664 Phenoxy Methyl Penicillin Potassium for oral suspension 250 mg/ 5 ml in 100 ml botiles (each 5 ml contains Phenoxy Methyl Penicillin Potassium equivalent to phenoxy methyl Penicillin 250 mq) 1000 bott!es Phenoxy Methyl Penicillin Potassium 5820 gm A‐3665 Erythromycin Stearate for oral suspension 250 mg/Sml in 100 ml bottles {each 5 ml contains Etrythromycin Stearate equivalent to EMhromycin 250 mq) 1000 bottles Erythromycin Stearate 7284 gm A-3666 Levofloxacin Tablets 500 mg (each tablet contains Levofloxacin Hemihydrate equivalent to Levofloxacin 500 mg on anhydrous basis ) 1000 Tab Levolfoxacin Hemihydrate 522750 gm A‐3667 Meropenem for injection 1 gm ( each vial contains MeropenemTrihydrate equivalent to Meropenem Anhydrous 1 gm) 1000 vials MeropenemTrihydra te 1 255 gm A‐3668 Methyl Prednisolone Sodium Succinate for injection 500 mg {each vial containing Methyl Prednisolone Sodium Succinate equivalent to Methyl Prednisolone 500 mq) Ｏ ｓ ‐ ０ ０ ｖｉ ａ ‐ Methyl Prednisolone Sodium Succinate 729.30 gm A‐ 3669 Metronidazole oral suspension 200 mg/5 ml, in 100 ml bottles(each 5 ml suspension contains Metronidazole Benzoate equivalent to 200 mg Metronidazole) 1000 bottles Metronidazole Benzoate 6753 gm A‐3670 Peloxacin ttab!et 400 mg(each tablet 1000 Peloxacin Mesylate 569731

contains Pefloxacin Mesylate equivalent to Pefloxacin 400 mq) 丁ab gm A‐ 3671 Phenoxymethyl Penicillin Potassium tablets 500 mg. {each tablet contains Phenoxymethyl Penicillin Potassium equivalent to Phenoxymethyl Penicillin 500 ms) 1000 Tab Phenoxy Methyl Penicillin Potassium 565.453 gm A-3672 Piperacillin and Tazobactam for injection 2.25 gm (each vial contains Piperacillin Sodium equivalent to Piperacillin 2 gms + Tazobactam Sodium equivalent to Tazobactam 0.25 gm) 1000 via:s

1. Piperacillin Sodium 2292.4 gm

Tazobactam Sodium 295.0 gm A‐3673 Primaquine Phosphate Tablets 2.5 mg (each tablet contains Primaquine Phophate equivalent to Primaquine 2.5 mq) 1000 Tab!ets Primaquine Phosphate 4.477 gm A‐3674 Rosuvastatin 10 mg Tablets (each tablet contains Rosuvastatin Calcium equivalent to Rosuvastatin 10 mg) 1000 Tablets Rosuvastatin Calcium 10.625 gm A‐3675 Spectinomycin injection 2 gmlvial (each vial contains Spectinomycin Hydrochloride equivalent to Spectinomvcin 2 qm) Ｏ 　 ｓ ‐ ０ ０ ｖｉ ａ ‐ Spectinomycin Hydrochloride 3278.00 gm A‐3676 Vaficomycin@ contains Vancomycin Hydrochloride equivalent to Vancomycin 500 mg, vial size less than 10ml) 1000 via!s Vancomycin Hydrochloride 566 50 gm A‐3677 Amoxicillin & Potassium Clavulanate for injection 1.2 g (each vial contains Amoxicillin Sodium equivalent to Amoxicillin 1000 mg and Potassium Clavulanate equivalent to Clavulanic Acid 200 mq) 1000 vials Sterile mixture of Amoxicillin Trihydrate & Potassium Clavulanate (5:1 ) 1320 gm 2. Effect of Public Notice:- SIONs of the above export products falling under the Chemicals and Allied products Group are being notified. These are new entries. D i recto r o " n ","1T Ho[filTt? E-mait: dgft@nic.in (lssued from File No. 01/82i162t00198/AM-16/DES ilt) 3

?*nt'O F. No.3501 1 1267 12013-PI (Norms) Government of India Ministry of Chemical & Fertilizers Department of Pharmaceuticals Udyog Bhawan, New Delhi, the24th June,20l3 Office Memorandum

Subject: - Fixation of norms under para4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of

M/s. Stericon Pharma Pvt Ltd. The undersigned is directed to refer to DGFT U.O.No. 0ll82l50l467lAM|3/DES-4/1055 dated the 0ll03ll3 vide which an application from IWs. Stericon Pharma Pvt Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Extreme Eyes 360m1, Yizulize Moisturizing And Comfort Drops-O.lYo & Vizulize 100m1. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009 -l 4:- S.No. Export Product Import Item Oty. Recommended. | Extreme Eyes 360m1 Sodium Hyaluronate BP NO DⅣIL 2. Yizulize Moisturizing And Comfort Drops-0.1% Sodium Hyaluronate BP 0.01 gm/10 ml Bottle 3. Yizulize Moisturizing And Comfort Drops-O.1% Sodium Hyaluronate BP 0.01 gm/10 ml Bottle 4. &Vizulize 1 00rnl Sodium Hyaluronate BP NO DML 2. This issues with the approval of Director (Cost). (Raj Kumar) Under Secretary, to the Government of India PI-Norms Directorate General of Foreign Trade, Department of Commerce, (Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi.

/ タレ iCase No:6/2/82- Party NameiHPL Meet No/Datei6/82- Status:Case lALC4/2oll ADDITI∨ES ALC4/201l Approved i lLIMITED(FORMERLY lo o5 2011 1 KNOWN HIGH POLYMER I白0116
良LA lilさ Lic No′ baiさ:661o266ラ6ラ
‐ 101/82/050/01796/AMl1/ :o5/23/040/00364/AMl1/ 24032011 the firm whichever is lower:- Export product Exp. Qty. Ｌ 　 Ｏ Ｓ Ｎ lmport items Qty. allowed 丁rls(3,5-Ditertiarybutyl‐ 4‐ hydroxy Benzyl) lsocyanurate(KINOX― 34) lkg 1 2,6 Ditertiary Butyl Phenol 0 962 kg 2 lsocyanuric Acid 0 201 kg 3 Para Formaldehyde 0140k9 4 Acetonitrile 0 300 kq RA concerned may take further necessary action as per above decision of Norms Committee.

ノ 多 ２ ５ ク ／ Ｋ 五 一 刺 Casc No.:164/3/82-Al″ C4/2014 Party Nalllc:CAMPHOR& ALiンIED PRODUCTS IンIヽ41TED, RLA Filc :03/94/040/00956/AM14/ Meet No/Date:3182- Status:Case AlンC4/2014 Approvecl 08.05.2014 1_ic.No/Datc:0310768971 0302.2014 HQ Filc :01/82/050/00168//ヽヽ415/ Defer Date: （ υ ― ・ Decision:ln the‖ ght of written comments received from Department Of Chemicals and Petrochemicals vide thelr u.O No 14010/20//2012‐ Ch.‖ dated 14.01.2014′ it was decided to‐ ratify norms under Para 4.7 of HBP vl as per detalls g市 en below or as applied by the irm′ ‐ whichever is less: Export product Export Quantity S.No. Import iter-ns Quantity Allowed ASTROMLJSK CONCENTRATE (Astronlusk Contcnt:1()()9る) ０ ０ l ISOAMYLENE 0.580 kg つ ４ PROPYLENE OXIDE 0.380 kg ALI)llA METHYL STYRENE 0.769 kg 4. PARAFORMALDEHYDE 0 117 kg RA may take appropriate action as per the decision of Norms committee. 1 轟

″ 井 列 Decision : ln the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/5Blz11,t-Ch. il dated 1,5.Og.ZOl4, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: t20 Export product Export Qt"v S.No. Inrport itenrs Quantity Allorved Hexyl Salicylate lkg l n-Hexanol (Lorol C 6/Nacol 6- ee) 0.5 l0 kg う ４ Sa‖ cy‖ c Acid 0.682 kg Casc No.:179/6/82‐ Party Name:BEST VALUE Mcet No/Date:10/82- lStatlis: ALC4/2014 CHEM PVT.1_TD. ALC4/2014 1Approved 12 11.2014 lZ II.2014 HQ F‖ c Rl´ AF‖ c Iンic.No/Datei3410039577 Dcfcr Date: :O1/82/050/00581//ヽlN/415/ :34/24/040/00308/AIヽ414/ 18032014 | | I RA may take apprOpriate action as perthe decision of Norms Cornmittee.

孝 F No.35011/128/2016-PI(Norms) Government oflndia Minlstry of Chemicals&Fertilizers Department of Pharrnaceuticals Shastri Bhawan, New Delhi, Dated the Decembet l{2016 Office Memorandum

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

Nectar Lifesciences Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501002041AM-17/DES-|ll/190 dated the 0410712016 vide which application from M/s. Nectar Lifesciences Ltd., was sent to this Department for fixation of norms under para. 4.7 for the export of Cefuroxime Axetil (DC Grade). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures: - S.No. !mport ltem Qty. Recommended kg/kg. Desacetyl-7-ami no cepha losporan ic acid (D-7-ACA) 0.474 2 Ethyl acetate 2.244 3 Methanol 0.372 4. Syn-methoxyimino furanyl acetic acid ammonium salt (sMrA) 0.501 5 Activated carbon 0.06 6. Phosphorous Pentachloride 0.582 7 N/ethylene Chloride 1.374 8. Acetic acid 0.288 9. Acetonitrile 0.588 10 Chlorosulphonyl lsocyanate 0.318 Acetone 1.056 12. Dimethyl acetamide 0.672 13. Cyclohexane 0.552 2) This issues with the approval of competent authority. (Atna,,lm" (BarnEli Khdgtgir) Under Secretary to the Government of lndia Phone:23323292 Email. barn.khast@nic.in (Shri Nirmal Kumar, Dy DGFT), Udyog Bhawan, New Delhi Email: nirmal.kumar65@nic.in /

⌒ ルクラト″ r ‐Case No.:83/9/82‐ ALC4/2014 Part、Name:IPCA ILABORATORIES LIヽlITED IN/1cct No/Datc:14/82- ‐ status: ALC｀4/2011 approved 22 !22011 HQ Filc RLA Filc Z2 122014 1 : Lic No/Datc:03107859 ‐Dctr Dale : :O1/82/050/00880/A■´I15/ :03/91/0■0/00223/Aレ115/ し1 11 107859 Dctr Datc: : |まま 111ふ き 1百薦群薔薇薔さ古[3品高さお[だ さ んさ brおふbさら :浅品き品湯II品::き轟だ:tlしき their OM No 35011/591/2013-Pl(Norms)dated 24.12.2013′ t was decided tO ratify nOrms under Para 4 7 of HBP vl as per detaltt given below oras applied by the nrm′ whicheveris iess: 14538 1 8463 1 1481 06756 16799 348 518 Norms COmmittee 一 〇 ｆ Ｏ Ｏ ｍ ― ― ― ― ― ― ― ― ― ― ― ― ― Ｉ Ｌ Ａ ‘ 　 ‘ 　 ， Ｉ Ｒ HYDROXY CHLOROQUINE SULPHATE Ethoxy rVlethvlene IVIalonic Acid Ester I E]VIME l Export product ヒxp Qtv SI No lmport items Acetobutvrolactone ( ABL ) 2 2-Ethylamino-Ethanol(Mono Ethyl Ethanolamine) 3 4 Metachloro Aniline S.B. Toluene 6 Methanol Iso Propl,l Alcohol Methylene Chloride ( Methvlene Di Chloride )

|` 一q

Case No.:72/17/82‐ ALC4/2013 Patty Name:RA CHEM

No/1Date:23/82‐ PHARMA LIMITED .No/Date:0910058435 :01/82/050/00934/AM14/ 109/24/040/00413/AM14/ may take appropriate action as per the decision of Norms Committee. : In the light of earlier decision taken in meeting no.52182 dated 27.03.2012,it decided to ratify norns under Para 4.7 of HBP vl as per details given below or as by the firm, whichever is less:

P赳 。10ギ F. No.3 50 I I I 459 12012-PI (lr{orms) Government of India Department of Pharmaceutical s Udyog Bhawan, New Delhi, the 3 1't October,2012. Office Memorandum Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case of NzVs Adcock Ingram Ltd. The undersigned is directed to refer to DGFT U.o.No. 0l/82/50/15l/AMl3/DES-3/181 dated the23104/12 vide which an application from lzl/s Adcock Ingram Ltd was sent to this Department for fixation oi ro.-s under para: 4.7 for the export of Calcium Carbonate + Glycine Tabtets. This department has examined the matter and the following comments are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S,No。 Export Product Quantity Raw materials allowed Quantity proposed 1 Calcium Carbonate t25O mg. + Glycine 535.7 mg Tabs. 1000 Tabs Calcium Carbonate Dense BPAJSP 1.25 kg つ “ Glycine usP/BP Not shOwn in DML 2. This′issues with the approva1 0fDirector(COSt)。 (N.NoAhtta) Section(Dfflcer PI…Nolllls (Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi.

?n"'t'-\o No.3501 1 1591 12014-Pl (Norms) Government of lndia Shastri Bhawan, New Delhi, Dated: March 16,2015 Office Memorandum

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

Case of M/s Granules lndia Ltd. The undersigned is directed to refer to DGFT U.O. No. 011821501008241AM1S/DES- 31876 dated the 24.11.2014 vide which an application from M/s. Granules lndia Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Compresso GEM 70 (Gemfibrozil Granules DC 70Yol. This department has examined the matter and the following norms are furnished under para4.7 of Hand Book of Procedures (Vol.l) 2009- 14.- S. No. lmport ltem Qty. Recommended kg/kg. Gemttbrozil 0.707 2 Starch Pregelatinised 0.083 3. Maize Starch 0.1485 4. Sodium Starch Glycollate 0.030 5. Povidone K-30 0.0270 6. Sodium Lauryl Sulphate 0.00150 7. Steattc Acid 0.0100 This issues with the approval of Director (Pharma lndustry). (Barnali Khastgir) Phone: 23385765 (Shri MVSingh,FTDO), Udyog Bhawan, New Delhi. l? 2.

Ｆ ラ 一 ⌒ ,電 ≒ ｒ 一 ル F No.3501 1lB64nA15-Pl (Norms) Government of lndia Udyog Bhawan, New Delhi, Dated: 27 April,2A16 Office Memorandum

Subject: - Fixation of norms under para4,7 of Hand Book of Procedures (Vol.l) 2009-

14 Case of M/s Mangalam Drugs & Organics Ltd. The undersigned is directed to refer to DGFT LJ.O.No. 01l82l5An646lAM- '16/DES-3/1762 dated the 213116 vide which application from M/s Mangalam Drugs & Organics Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export 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:- Norms Recommended l o lk9 ExpOt__ J 唾I達懇撫:亀 つ ４ This issues with the approval of competent authority ___望距k9__J (Ralkumar) Under Secretary to the Government oflndia PHi-23071162 (Shri M V. Singh, FTDO), ~｀ (て、 `/′ ′ ′ 4) lmport ltem S No

′≦ニ イ ― ― ― ― ― ― ― ― ― ― ！ 一 txport product Exp. Qtv. SI No lmport items Qty. allowed Methyl Triphenyl Phosphonium Bromide l Kg Triphenyl Phosphine 0 886 kg RA concerned may take further necessary action as per above decision of NC. Party NameittATVA Meet No/Datei26/82‐ CHINTAN PHARMA CHEM ALC4/2011 PVtt LttD 27 09 2011 RLA F‖ e Lic No/Date:3410031410 1 :34/24/040/00o86/AM12/ 05092011 1 Dedtton i cOmmttee conddettd case as per a潟 ::二18〃|1瓢』 :∫梶 1ぷTtti『γ:猟冨薔 |:#‐ "7薗踊F麒覗 i讐器備鮒皿r断訓″ nOrms mtt para 47 d tthS per

Case No i41/26/82-

ALC4/2011 HQ File i01/82/050/00724/ANl1 2/ Status:Case Approved

l g =鶴 冨

Case No.:22/15/82‐ ALC4/2013

Party Name:YASHO INDUSTRIES PVT.LTD. ALC4/2013 19.12.2013 Decision:ln the l:ght of wtttten comments received from Department of Chemicals〔 Petrochemicals vide their u.O No.14010/95/2011-Ch ll dated 26.12.2013′ it was decided ratify norms under Para 4,7 of HBP vl as per details g市 en below or as applied by the nl whicheveris less: Export product Exp. Qty. SIoNo. lmport items Qty. allowed OCTYLATED DIPHENYLAMINE( OCD FLAKES/ POWDED l kg DIPHENYLAMINE 0.405 kg 2. DI‐ISOBUTYLENE 0.620 kg 3. ACTIVATED CLAY The role of Activated Clay not known and so not recommended may take appropriate action as per the decision of Norms Committee.

二_ Ⅲζtttat′jた,LALc・4たbi4 1轟,Na品どёL6百AL ■ よ ヽj5農ぎ b′を,I もi:ti"1;よ | [鵬 WPNVATE ttχ ttF Ⅲ ЮWd 鶏脱鵬鳥 1詰j 協璃鶏 :嵐為島 :需究十 "品め商Ⅲ5Ⅲ Ⅲ ι :ζiI:ll ilt iょ::1轟∴ tiき1::ふ蔦と 11::き::諾:キ|:‖ 6:詰ふき 11:|ど1:鳥i::ι :1:: 々匂′∫7う ‐ | ICaseト Petrochemicais vide their u o No 14010/56/201l Ch ‖dated 23 05 2012,t was decided to ratify normsl under Para 4 7 of HBP vl as per deta‖ sg市en below Or as applied by the lrm′ whichever is less: : 1230 Export product 呻 Ｑ ｕ ａ ｎ ｔ ｉ lmport items ｔ ｙ ｄ ｕ ａ ｎ ｔ ｉ ‐ 。 ｗ ｅ Ｑ Ａ ‐ CALCIUM LACTATE GLUCONATE CALCIUM GLUCONATE― Oral Grade 0 686 kg 2 CALCIUM CARBONATE 0 310 kg 3 LACTIC ACID 0 560 kg FERROUS GLUCONATE 1 LACTIC ACID 1 028 kg MAGNESIUM LACTATE 1 LACTIC ACID 1 19 kg ZINC LACTATE 1 LACTIC ACID 0 990 kg MAGNESIUM LACTATE GLUCONATE LACTIC ACID 0 390 kg RA may take appropriate action as per the decision of Norms Committee.

上 げ | ICase No.:25/_5/82-ALC4/2014 Party Namc:GLOBAL I : ICALCIUM PRIVATE I I LIMITED :HQ Fi13 1蔦LA llit 101/82/050/00342/AM15/ 1:07/24/040/00340/AM14/ 14 16 Ｓ ‐ Ｎ Export product Exp Qty lmport items Qty Aliowed | NIAGNESIUM OROTATE OROTIC ACID 1 104 kg CALCIUM OROTATE OROTIC ACID 1059 POTASSIUM OROTATE OROTIC ACID 1020 4 ZINC OROTATE OROTIC ACID 0980 FERROUS OROTATE OROTIC ACID 0.976 kg Decision : ln the light of written comments received from Department of Chemicals and Petrochemicals vide their U.o No. t4oto/s61201,1-ch. I dated Lg.o7.2oL4, it was decided to ratify norms under Para 4.7 of HBp v1- as per details given below or as applied by the firm, rwhichever is less: RA may take appropnate action as perthe declsion of Norms Commttee

⌒ if てか Casc No.:2/4/82-ALC4/2013 Party Nanlc:CAMPHOR& Mcet No/Date:4/82- statlls:Case AIン1.lED PRODUCTS ALC4/2013 Approved l LIヽ4「FED、 1605.2013 LIヽ4「FED、 1605.2013 HQ F‖ c RL´ A IPile Lic No/Date:0310725118 Defer Date: :O1/82/050/00043/′ へM14/ :03/94/040/00937/Aヽ413/ 21.022013 Decision : In the light of rvrilten comments receivecl from Department of Chemicals and 22q Petrochemicals vide their LI.O No. 1401012012012-Cli. II clatecl 13.3.2013, it was clecided to ratifl' nonrs under Para4.7 ol'I{BI'>r,1 as per cletails given below or as appliecl by the firm, whichever is less: Export product Exp Qty SI No lmport items Qtv. allowed Camphor USP l kg 1 Alpha Pinene 1 146 kg RA may take appropriate action as per the cleciiion of Nc,.,rrs commi t+) tu/ /t)ttu I l-u11. ll Clatecl 13.3.'ztJ I 3, rt was decided IIIP r,1 as per details given below or as applied by the I St ruo I tmport items TOty --l I I lallowed I | 1 | Alpha pinene | 1.146 ks I

ハ |ブ IDccision:ln the light Of written comments received from Department Of chemicals and Petrochemicals vide their u.o No.14010/49/2011-Ch‖ dated 19.08.2013′ it was decided to ratify [1:TSunderPara4.7 of HBP vl as per detalls g"en be10w Or as applた d by the nrm′ whたhever ζ Casc No.:9/8/82-ALC4/2013 Party Nanlc:GULBRANDSEN McetNo/Date:14/82‐ stitlis:こlζ CHEMICALS PVTIンTD ALC4/2013 Approved 124.10.2013 ‐ IHQ Filc RIッA File Lic.N8/bit`:j41bbjと ;,o‐ Defcr bitざ : |:O1/82/050/00140/AM14/ :34/24/040/003‖ /AM13/ 25.03.2013 1 may take appropriate action as per the decision of Norms Committee. rich10ride(M BTc) ｋ ｇ 　 　 Ｄ ｎ 　 ｋ ｇ Aluminium Granules/Grit butyl丁in Oxlde

1籍 濡伊 晟ふ :需 諦熱iAL M轟 赫bttЙメ 輛姦 | :TE :ALC4/2014 approved i : : :LIMITED. 25092014 1 1 1 鷺 瓢 ::λ::::;鳥|:; ヽ吼 "l,j話 :11↓|″
塩:譜鵠186ウ ibibbj,4幌IF 5晟ど | IDecislon:cOmmittee considerき るthe t:se:slま a:nd:and i^light 81 wnttei。mttelts lreCeiVed from Department of Pharmaceutlcab vide their oM No 35011/26/2013-PI(Norms)| dated 22 01 2014 and in consuLa●on wth technical authOnty present in meeung′ decided to l ratify norms under para 4 7 of HBP as per detalls g■ en below or as applied by lrm whたheverヽ| lower:- Export product Exp Qty SI No. lmport items Qty.Allowed CALCIUM LACTOBl()NATE CALCIUM CARBONATE 0145 LACTOSE CALCIUM BROMO LACTOBIONATE CALCIUM CAR30NATE 0233 LACTOSE HYDROBROMIC ACID 43% 0.421 CALCIUM GLUBIONATE l KG CALCIUM CARBONATE 0212 2 LACTOSE 0.785 LACTOBIONIC ACID l KG 1 CALCIUM CARBONATE 0.187 2 LACTOSE 1305 RA maytake appropriate action as perthe aecffi コ :

Ｆ 一 リ ILIMITED, :RLA F‖ c lLic No/Date:0710090154 107/24/040/00142/AM13/ lo9 o8 2012 may take appropriate action as per the decisioffi :01/82/050/00658/AM13/ :ision : In the light of earlier decision taken in meeting no. 36 d;i;d ,.12.2010, il"*a, ided to ratify norms under Para4.7 of HBP vl as perdetails given below oras applied by firm, whichever is less: Calcium Boro Gluconate Calcium Gluconate (Oral Grade

ハ ノ≦言 一71 Party Name:GLOBAL ICALCIUM PRIVATE ILIMITED、 IRLA F‖e i07/24/040/00474/AM14/ Ｌ 　 　 　 　 　 　 　 　 Ａ declsion of Norms Commttee. 一 ｈ ｅ Ｏ may No.:141ん/82‐ is less: Sl. No. Export product Exp. Qtv. lmport items Qty AIlowed | MAGNESIUヽイLACTATE GLUCONATE l kg GLUCONATE DELTA LACTONE 0 755 KG COBALT GLUCONATE l kg 1 036 KG ZNC GLUCONATE l kg 0 945 KG 4 ヽ4AGNESIUヽ4 GLUCONATE l kg 0 945 KG ) POTASSIUM GLUCONATE l kg 0.930 KG FERROUS GLUCONATE l kg 0 887 KG ヽ4ANGANESE GLUCONATE l kg 0 945 KG CALCIUヽ4 MANGNESIUM LACTATE CLUCONATE l kg 0.831 KG

lζ イ ル F. No.3501 1/66212015-Pl (Norms) Government of lndia Dated: 18 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 Jodas Expoim Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82l50/850/AM- 16/DES-3/889 dated the 3/9/15 vide which application from M/s Jodas Expoim pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for lhe export of Cefoperezone & Sulabactum for injection 1gm and 29m. This deparlment has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- 2. This issues with the approval of competent authority. (Ralkumar) Under Secretary to the Government oflndia PH:-23071162 Directo「ate General of Foreign Trade, Depanment Of Commerce, (Shn M V Singh,FTDO), Udyog Bhawan,New Delhi S No lmport item For Export of 1 No. injection 1qm iniection 2gm injection 1 Cefoperazone Sodium and sulbactum sodium (1 :1 ) Sterile 1.12gmlvial 2.24gmlvial ハ

|ダ 一4`

Case No.:23/2/82-ALC4/2013

Pal■y Nanlc:PERFECT BIOTECH ヽ4cet No/Date:2/82‐ ALC4/2013 Status:Case Approved Defer Date: 1804.2013 Lic.No/Date:0310587494 13.08.2010 appropriate action as per the decision of Norms Committee. RLA Filc :03/95/040/00326/AMI1/ Export product Exp Qty SI No lmport items Qtv. allowed Soya Lecithin Powder lM丁 Soya Liquid Lecithin 120 MT 2 Acetone 690 Ltr 3 HWroqen Pexoxide 00咬MT 4 鸞柩 稿X100 ns pe\ packing policy RA may take approoriate action as ner the decisi HQ Filc 16 the firm, whichever is less:

F. No.3501 1 t779t201t_pt (Norms) Government of lndia Ministry of Chemicals & Fertilizers Department of pha rmaceuticals Shastri Bhawan, New Delhi, Dated the December 16, 2016 Subject:-Fixationofnorms.undero",.ffiProcedures(Vol.l)2oog-14CaseofM/s Shalina Laboratories pvt. Ltd. The undersigned is directed to refer to DGFT U.o. No. 01r}2tsoto1435/AM-16/DES-ilr/1406 dated the 1110112016 vide which application from M/s. snarina Laboratories pvt. Ltd., was sent to this Department for fixation of norms under para: 4.7 .for the exfort of Epiderm Lotion in 30 ml botttes. I$.t;5#:lJl"::ffi::mtned the matter and the r"rr"*irit norms are rurnished under pi,i-i.-iit (Shri NirmalKumar, Dy DGFT), Email : nirmal. kumar65@nic. in Under Secretary tO the Go縄昇 |II』II:「疑 Phone:23323292 EmJI:barn.khastonた.in Product toEe exporteO Raw materiEls to be Qty applied pei 1000 botttes Epiderm t-otionJ0 nrt bottles (eaCh bottle contains BetamethasOne 005%, w/w, lodochiO「Ohydroxy 崖断 榊 ll gmi lrvhte sO貴 ParafFin (PetrOleum Je:ly)o6 gm and Propylene Glyco1 1 5 1000 bottles 612.00 gm Whle SOft ParafFin (PetrOleum Jelly) 612.00 gm 1530 00 gm 2) This issues with the approval of competent authority.

F. No.3501 1/13112014-Pl (Norms) Government of lndia Shastri Bhawan, New Delhi, the 20 January, 2015 Office Memorandum

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

14 Case of M/s Softgel Healthcare Pvt Ltd. The undersigned is directed to refer to DGFT U.O.No. 01lB2l50l00522lAM- 15/DES-3/583 dated the 05109114 vide which application from M/s. Softgel Healthcare Pvt Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Soft Gelatin Capsules Vitamin A. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-1 4:- lmoort ltem (1) Vitamin A Palmitate '1 .7 MIU/gm:---------30.0m9/50,0001U Capsule (2) Vitamin A Palmitate 1.7 MIU/gm-----------60.0m9/1 00,0001U Capsule (3) Vitamin A Palmitate '1 .7 MIU/gm----------------120.0m9/200,0001U Capsule This issues with the approval of Director (Pharma lndustry) (Raj Kumar) Phone:-23071 162 (Shri M.V. Singh, FTDO),

ｒ 各 / ″ Govemment of India Ministry of Chemicals and Fertilizers Department of Chemicals and Petrochemicals Subject Advance Authorization application from M/s. Esteem lndustries Rrt. Ltd. for the import of raw material against the export of Glycerin Ester (Advance Authorization No. 1710006170 dated 04.9.2015) Ref: U. O. No. 01 /8?0 5Ol 1277 I AM' I 6/DES{ llll 3 1 0 dated 16.12,201 5 M/s. Esteem lndustries Pvt. Ltd. has submitted present application for the import of raw materia! against the export of Glycerin Ester The application has been examined and the Department recommends the following norms for the present Advance Authorization application. This issue with the approval of competent authority. い

い Addi.indust面al Adviser Tel.No.011‐23381430 |.2016

1. ltem of Export Qty. Item of lmport Qty Glyce‖ n Ester l kg
2. Ethylene Oxide 0.6483 kg. 2.Stearic Acid 0.2790 kg /

HQ File :01/82/050/00136/AM 13/ :RLA F‖ e ::03/94/040/01054/AM12/ ALC4/2012 19062012 Lic No/Date:0310684468 |「 フレ%ノク Sイ ' IDefer iDate:19.062012 202 Decision:Committee considered case as per agenda and in light of written comments forwarded Эy Deptt Of C&PC vide their U.0.No. 14010/29/2011-Ch‐ ll dated 25 05.2012 and in consultation ″ith technical authority present in meeting′ decided to ratify norms under para 4 7 of HBP as per below or as firm whichever is lower:- Export product Exp. Qty. lmport items Qty. allowed 2′ 4′ 6-TRI M[THYL PHENYL ACETYL CHLORIDE l kg 1,3′ 5-TRIM ETHYL BENZENE OR「MESITYLENE 1 490 kg PARAFORMALD[HYDE 0 804 kg SODi∪M CYANIDE 0 456 kg CAUST!C SODA FLAKES 2 290 kg TH10NYL CHLORIDE 0 730 kg RA concerned may take further necessary action as per above decision of NC.

ls -.-4t72- F. No.3501 1181112015-Pt (Norms) Government of lndia Dated: 7 June, 2016 Office Melnglandum

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. Q1tg2t5ot700/AM- 15/DES-3/1623 dated the 16t2116 vide which application frorn ly/s RA Chem pharma Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Medazolam, Midazolam Hcl, Midazolam Maleate. This department has examined the matter and the following norms are furnished under paia 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- Note:'The firm has not given the technical details for midazolam Hcl and midezolam maleate 2. (Rajkumar) PH- 23071162 S.No lmport item Norms Recommended for 1kg Export 1 枷 史 h10r。_2Juor6 benzOphenone 3.50kq 2 lyl aCetal 2.60ks ３ 一 ４ Manganese dioxide 3.20kq Dimethyl sulfoxide 1 60ks 5 Acetone 2.B9ks 6 Triethyl ortho acetate 2.56ks 7 Methanol 6.90ks 8 Methylene chloride 9.94kq

F. No.3_501 1 t779t201$,pt (Norms) Government of lndia Ministry of Chemicals & Fertilizers Department of pharmaceuticals Shastri Bhawan, New Delhi, Dated the December 16,2016 Subject:-Fixationofnormsundero","ffiProcedures(VoI.l)2oog-14CaseofM/s Shalina Laboratories pvt. Ltd. . ..Th9 undersigned is directed to refer to DGFT U.o. No. 01l}2lsolo1143/AM-16 tDEs-lllt127z dated the 16/1212015 vide which application from M/s. Shalina Laboratories pvt. Ltd., was sent to this Department for fixation of norms under par.a .4.7 for the export of Betaso! Cream in 15 gm and 30 gm tubes' This department has examined the matter and the following noiri are furnished under

para 4.7 of Hand Book of procedures: _

(Shri Nirmal Kumar, Dy DGFT), Email: nirmal.kumar65@nic.in 徹嘔 嘘 UnderSecretarytOtheGol:鷲II」‖ I:『l111! Phone:23323292 Emall:barn.khastonたin Productt@ nawm@ S No Description Qty b No りescttpt,On Qty applied for 1 000 tubes Qty recommended for 10oo tubes 7.65 gm Betasol Cream-in tS $n tubes (each tube contains Clobetasol propoionate equivalent to Betamethasone 0.05%, w/w, Cetosteryl Alcohol 1.1995 gm, White Soft Paraffin 1.4994 gm and Propylene Gtycol 0.7409 gm) 1000 tubes 1 BetamethasOne (APり /65 gm 2 Cetosteryl Alcohol 1224 00 gm 1199.52 gm 3 whne soft Paraffin 1530.00 gm 1499.40 gm 4 Propylene Glycol 756.00 gm 740。90 gm 2. Betaso! Cre.m-in aO gm tubes(each tube contains Clobetasol propoionate equivalent to Betamethasone 0.05%, Ww, Cetosteryl Alcohol 2.399 gm, White Soft Paraffin 3 gm and Propylene Gtycol 1.51 sm) 1000 tubes Betametha― sOne (API) 15.30 gm 15.30 gm 2 Cetosteryl Alcohol 2448 00 gm 2399.00 gm 3 Whlte sOft Paraffin 3060 00 gm 3000,oO gm 4 Propylene Glycol 1530.00 gm 1510.Oo gm 2) This issues with the approval of competent authority. ハ

下千 ― ― 浮 Government of lndia Ministry of Chemicats and Fer^tilizer-s Depariment of Chemicals and peirolfre"micafs

subject: Advance Authorization application from M/s. yasho lndustries pvt. Ltd. for the

import of raw materials against the export of yantq 20308 (25% solution of Tertiary Butyt Hydroquinone) (Advance Authorization No. 031 o7g242'- dated 29.12.2014) (Advance Authorization No. 031 olgitis dated 4.3.2015) Ref: U'O' No' 01182/050/260,4BO,AM16/DES-ilt/188, 361 dated 29.6.2015 and 3.7.2015 I\r/s Yasho lndustries (P) Ltd' has submitted present apprications for the import of raw materials against the export of yantn 2n?np Hydroquincne) ur r ?nrn )tt'1Ite (25o/o Sclution of Teriiary Butyl norms rlffrii:J::Xil"lilJT|,ffill},'#fl.:?:,Department recommends the rorowins

1. ltem of Exporl Qty ltem Oflに
2. HydroquinOne Qty γanlq zo3uB(250/O SOlution Of 丁e減lary Butyl HydroquinOne) l kg 035, κ0 ∠.l erliaryじutanOl 3 PЮ pプene αycd 0.260 Kg 0.650 Kg. Addl.lndustttal Advisel Tel No oll_23381430 n Vi h Deptt.Of c&Pc U.〇.No. 14010/95/2011 dated \1.9.201S

tr F. No.3501 1 1779t2016pt (Norms) Government of lndia Ministry of Chemicals & Fertilizers t60 Shastri Bhawan, New Delhi, Dated the December 16, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of ftanO gook of Procedures (Vol.l) 2OOg-14 Case of M/s

Shalina Laboratories pvt. Ltd. . .The_undersigned is directed to refer to DGFT u.o. No. 01t82t5oto13g1/AM-16/DES-1il/1476 dated the 1210112016 vide which application from M/s. Shalina Laboratories pvt. Ltd., was sent to this Department for fixation of norms under para: 4.7 for the export of Epiderm cream 15 gm and 30 gm tubes. This department has examined the matter and the following norms are furnish-ed under pfra 4.7 of Hand Book of Procedures: - lfrtt*,'l-f, (Barnali Khastgir) Phone: 23323292 Email: barn.khast@nic. in (Shri Nirmal Kumar, Dy DGFT), Email: nirmal.kumar65@nic.in Product to beExported Raw materiats to Ue tmportea ● ０ Ｓ Ｎ Description Qty S. No Description Qty applied per 1000 tubes Qtv recommended per 1000 tubes Epiderm Cream i5 gm Tube (each tube contains Betametha-sone Dipropionate equivalent to Betamethasone 0.050/o w/w, lodo-chlorohydroxy Quinoline 149 mg, Gentamicin 1S.00 mg, Cetosteryl Alcohot 1.2 gm, White Soft paraffin (Petroleum Jelly) 1.500 gm and Propylene Gtycot 0.750 gm) 1 000 tubes Betamethasone (APt) 8.555 gm 7.650 gm 2 lodochloro-hydroxy Quinoline (APl) 152.00 gm 152.00 gm 3 Gentamicin Sulphate (APr) 15.30 gm 15.30 gm 4 Cetosteryl Alcohol 1224.00 gm 1200.00 gm 5 White Soft Paraffin (Petroleum Jelly) 1530.00 gm 1500.00 gm 6 Propylene Glycol 765.00 gm 750.00 gm 2. Epiderm Creim-Olm tuOe (each tube contains Betamethasone Dipropionate equivalent to Betamethasone 0.05% w/w lodo- chlorohydroxy Quinoline 306 mg, Gentamicin 30.60 mg, Cetosteryl Alcohot 2.399 gm, White Soft Paraffin (Petroleum Jelly) 3.00 gm and Propylene Glycol 1.5 gm) '1000 tubes 1 Betamethasone Dipropion-ate (APt) 17.110 gm 15.300 gm 2 lodochloro-hydroxy Quinoline (APl) 306.00 gm 306.00 gm 3 Gentamicin Sulphate (APt) 30.600 gm 30.600 gm 4 Cetosteryl Alcohol 2448.00 gm 2399.00 gm 5 White Soft Paraffin (Petroleum Jelly) 3060.00 gm 3000.00 gm 6 Propylene Glycol 1530.00 gm 1500.00 gm 2) This issues with the approval of competent authority.

K W3 Ｐ 　 Ｐ ICaSe |

case No.:52l4g182-Alc4lzotL lerrty rur.",iAsio tNDUsiRtEs itvt."t rrto/ort e:12/82-

lPW.LrD. IALC4/2012 I lo3.o7.2ot2 ri xq-Fil"-- [;C- -Fn"/Drt"'o31oos3gsa :0U82l050l0t37tlAMt2/ lio3lgsl}4oloL}t4/AMtz/ l2g.O2.2ot2 rl oecil;" ' comilinee consioereo c;se aJGi ;genoi and -in t,gr,i oiiiriJ comrneni Deptt of C&PC vide their O.M..No. 1401016012011-Ch.ll dated 01 .11.2010 and in cr technical authority present in meeting, decided to ratify norms under para 4.7 of HBI below or as applied by firm whichever is lower:- --lt;r*ilt , i I I I I t____ :s forwarded by rnsultation with ) as per details Export product Exp. Qty. SI.No. lmport items Qty. allowed YAPOX CL 30/10 Hydroquinone BIS (2 hydroxy ethyl ether l Kg. Hydroquinone 0.611 kg 2‐Chioro Ethanol 0.903 kg concerned may take further necessary action as per above decision of NC.

Ｆ 輌 Name:BASE TAL ATI (P)LTD :34/24/040/00255/AM12/ No/Date:6/82- 12 12 1悧盤“ 4∞劉8 may take appropriate Committee. : In the light of earlier decision taken in meeting no.6182 dated 10.5.2011, it was decided to ratify under Para 4.7 of HBP vl on repeat basis, as per details below or as applied by the firm, whichever is

F. No.3501 'tl784t2015-pt (Norms) Government of lndia Dated: 29, 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 Venus Remedies Ltd. The undersigned is directed to refer to DGFT U.o.No. o1lg2l5ol14o4tAM- '16IDES-3/1534 dated the 14l1/16 vide which application from M/s venus Remedies Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of cefepime for injection usp 1000mg. This department has examined the matt'er and the following norms are furnished under para 4.7 of Hand Book of procedures (Vol.l) 2009-14- S.No. lmport ltem Norms Recommended 1 Cefepime Hcl/L-arginine strile USp 1.89759m/1gm vial Under secretary to the Governr$i'ji'ffi'? PH:- 23071162 (Shri M.V Singh, FTDO),

ハ ‘ 7

Case No i43/14/82- Party NameiBEST VALUE Meet No′

Date:26/82‐ status:Case l ALC4ノ201l cHEM PVT LTD ALC4/2011 1Approved 27o92011 1 HQ FIle RLA File Lic No/Datei341 0030384 1 i01/82/050/00434/AM12/ :34/24/040/00027/AA/112/ 26052011 Decision i i cOmmittee considered case as per agenda and in light of written conlments fon″ arded by Department Of c&Pc vide thel「 u O No14010/58/2011-Ch‖ dated 23 09 201l and in l10 COnsuitatiOn wlth technical authoritles present in meeting, decided to ratify norms under para 4 7 of HBP as per detalls below or as applied by firm whicheveris ioweri― 1 1 |IMel° nら1 1lK9 摩斗罫栴撚榊≡‐ I RA concerned may take further necessary action as per above decision of NC Export product Exp. Qtv. SI NO lmport items Qty. allowed Melonal l K9 Methyl Heptanone 1 125 kg 2 Ethyl chloro Acetate 1 201 kg 3 Sodium Methoxide 0 562 kq

File No.35011ノ38ノ2016‐ P卜Norrns F.No.35011/38/2016-PI(Norms) Government of india Ministry of chemical&Fenilizers Department Of Pharrnaceuticals Shast‖ Bhawan,New Delhi, Dated:November21,2016 倫 Office Memorandum Sub: - Fixation of norms under para 4.7-Application of M/s Gland Pharma Ltd. ^_.^^i!: undersigned is directed to refer to DGFT U-O. No. 01 t82tos0t01 B0B/AM- 1 6/DES-s/03 dat ed oqtoitzol{=ffi subsequent letter from M/s Grand pharma Ltd. for fixation of 19rms. against u*pgll. of Sodium Hyaluronate tnjection 10mg/ml, 2ml pre-Filled Syringes. f nis Oepartr"^t h;; examined the matter and foilowing norms are recommended against this application. 2. This issues with the approval of Director (pharma lndustry). (Barna‖ Khastgir) Under SecretarytO the Govemment of:ndia Phone:23323292 Directorate General of Foreign ttrade, Depanment Of cOmmerce, (Sh‖ M V Singh,日「DO), Udyog Bhawan,New Delhi Product to be Exported Raw materials to be tmportE Quantity for Sodium Hyaluronate lnjection (containing 10 mg Sodium Hyaluronate per mlin 2 mlvials). Sodium Hyaluronate Plunger Stoppers Rubber Plunger Rods Plastic :08:51 1ST ⌒ Signatu

F ile No.350 1 1 13612016-Pl -Norms n
'..., : F. No.3501 1 13612016- Pt (Norms) Government of lndia Janpath Bhawan, New Delhi, Dated: November 18, 2016 Off ice Memorandum sub: - Fixation of norms under para 4.7- Application of M/s Unlink Pharma (p) Ltd. The undersigned is directed to refer to DGFT U.o. No. 01 I 821 050 I 0 17 97 I AM-1 6/DES- 3/i 4 dated 04 I 04 t2o 16 and s u us eq,,,ent letter f rom M/s ullitk pharma (p) Ltd. f or f ixation of norms against export of Penicillin-v zs} mg Tablets. This department has examined the matter and f ollowing norms are recommended against this application. 2- This issues with the approvar of Director (pharma rndustry). (Barnati Khastgir) Phone:23323292 Email: barn.khast@nic.in Department of Co mmerce, (Shri Nirmal Kumar, Dy DGFT), Email: nirmal.kumar65@ n ic.in メ lqη Product to be Exported Raw materials tO be:mpOrted S.Ⅳo Description Quantity Description Quantity for 1000 tablets 1 Penicillin-V 250 mg Tablets (each tablet containing Phenoxy Methyl Penicillin Potassium equivalent to 250 mg Penicillin-V) 1000 tabiets Phenoxy Methy: Penici:lin Potass:um 280 rng :25:49 1ST Signatu lid

per above decision of NC. necessary Export product Exp. Qty. SI No lmport items Qtv allowed Sodium Acetate (Trihydrate) l Kg Acetlc Acld 0 463 kg 2 Caustic Soda Lye 0 590 kg RA concerned may take further action as | ICase No 14/29/82-ALC4/201l Party NameiDU」ODWALA ,Meet No/Datei33/82- lStatus:casei l
‐PRODUCttS LttD, IALC4/2011 1Approved i 15112011 1 1 ‐ ‐HQ File
‐RLA File Lic No/Datei0310644792 1 i 101/82/050/00803/AM12/ :03/94/040/00814/AMl1/ 127072011 1 1 p画面m icom耐 ∝cOnsd釘 “ ∽∞ぉ "r悶 糖 乳‖!躙∬I岬 酬 TTγ :Ⅷ 薔i:‖ | ‐ ‐Department of c&Pc vide their U O No 14010/1 641W‖ h teChnical authonty present in meeting, decided to ra‖ fy norms under para 4 7 of HBP as perl detalls below or as applied by firm whicheveris loweri― |

´ Ｓ ヌl`′ ノリで ICase No.:64/18/82‐ ALC4/2012 IHQ Filc 101/82/050/00559/AⅣl13/ Party Namc:BENZO CHEM INDUSTRIES PRIVATE :LIMITED, RLA File :03/94/040/00273/AN113/ Mcct No/Datc:18/82- IALC4/2012 ‐30082012 :Case Approved ILic No/Datc:0310701792 Defer Date: 113072012 Decision : In Petrochemicals i取 the light of written vide their U.O No. comments received 14010/29/2011… Ch. from Department ll dated 25.5.2012, of Chemicals and it was decided to ify norms under Para4.7 of HBP vl as per details given below or as applied by the firm, ichever is less: Export product Exp Qty SI No lmport items Qty. allowed Para Chloro Phenyl Acetic Acid l kg Para Chloro Benzyl Cyanide 1 021 kg 2 Toluene 0 230 kg 3. Caustic Soda Flakes 0 360 kg RA may take appropriate action as per the decision orNorms committee.

⌒ ノ 「 2,7,526 , ;2+, g28 | ICase No.:114/10/82‐ Party Namc:BENZO CHEM Mcet No/Date:18/82- status:Case: | :ALC4/2013 1NDUSTRIES PRIVATE :ALC4/2013 1ADDrOVed i IALC4/2013 1NDUSTRIES PRIVATE IALC4/2013 :Approved i l lLIMITED, 119.122013 1 1 1角OFlЪ ‐ lRLA百iざ ^ =i`:ヽ8′ b:1さbjibウシ4」i b8驀f5姦:~| |:01/82/050/00297/AM14/ 1:o3/94/040/00991/AM13/ 108032013 1 1 I)ecision :in the ‖ght of written comments received from Department of Chemicals andi Petrochemicals vide their u.O No.14010/29/2011-Ch i!dated 26 12.2013′ it was decided tol ‐ratify norms under Para 4 7 of HBP vl as per detalls g市 en below or as applied by the irm′ ! 'whicheveris less: 721 : | Export product Exp. Qty SI No. lmport items Qty. allowed 2,4-DICHLORO PHENYL ACETYL CHLORIDE l kg 1. 2,4-DICHLORO BENZYL CHLORIDE 1 830 kg 2 SODIUM CYANIDE 0.518 kg 3. TOLUENE 0.513 kg 4. TH10NYL CHLORIDE 0.665 kg 5. CAUSTIC SODA FLAKES 0.640 kg || | 15: |こ天 53〒iこζ 55天FEラ IRA maytake appropriate action as perthe decision ofNorms Committee applied by the irm′ |

|

転:¨ | ‖瀧柵 蠅鷹 燃F聯職:暇燃i鵠Ψ蹴蹴欄 蠍l露 er飩贈 47 oF酷Fこ‐ 誰■:温・∬T毬虚撃警亀 li輩l;驚富 PhmガPhhalttJ 槻奮 2κ屁_ l野heRAY l:0t / 82t 0 s0 toff.t 4 t Akt I 5 t 」 ぎ ミ

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を 214,鶴み 窃 ｎ ン 服 淵 /15/82‐ 1躙 隠 皿 TD猫 謝 r"ド 漑Te 棚 掲剛∞η″AMW脇 馳υ∞ "7ハmダ 圏 郷 α TЮ Ъ T8PebD配 Decision:ln the light of wntten cOmments received from Department of Chem:ca:s and Petrochemica:s vide the:ru.O No.14010/95/2011/Ch‖ dated 26.02.2014′ 性was decided to ratify norms under Para 4.7 of HBP vl as per details g市 en below or as applied by the irm′ whichever is less: Export Product Export Quantity S.No lmport Product Quantity Allowed l kg 1. CLOVE LEAF OIL 1.51 kg 2. RUTHENIUM(IH)2,4 PENTANEDIONATE( RUTHENIUM ACETYLACETONATE) 0.001 kg

工 郊 No.:4R/2R/R2_AI′ r4/,ol,par純N,mp・V ミ■J∩ |
ド DUSTRIES PV■LT) 断″ 鰍: ~ 1聯 蔦 五 ~ 鵬児 5剛m5晨mν
丁けギ郷“ 31071組"PttrDに | | | Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010195/2011-Ch. II dated 2.4.2013, it was decided to ratify norns under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less: Exn lmnarf itame A+rr [:` |こ J I I Ч ιy Zinc Piperidlne Dlhiocarbamate (ZPD) l kg 1 Piperidine 0.542 kg may take appropriate action as per the decision of Norrns committee.

μ 2gレ F. No.3501 1 18312016-Pl (Norms) Government of lndia Ministry of Chemicals & Fertilizers Shastri Bhawan,New Delhi, Dated the December 21,2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2OOg-14 Case of

M/s BDR Pharmaceuticals lnternational Pvt. Ltd. The undersigned is directed to refer to DGFT U.O. No. 011821050/01836/AM-16/DES-il1/77 dated the 10/05/2016 vide which application from M/s. BDR Pharmaceuticals lnternational Pvt. Ltd., was sent to this Department for fixation of norms under para: 4.7 for the export of Citicoline Piracetam 500 mg + 400 mg Tablets (Pack of 50 Tablets) This department has examined the matter and the norms against the above product are furnished as follows: - Product to be Exported Raw materials to be lmported Description Quantity ● 　 ０ Ｓ Ｎ Description Quantity recommended for 1000 tablets Citicoline Piracetam 500 mg + 400 mg Tablets( each Film Coated Tablet contains Citicoline Sodium equivalent to 500 mg Citicoline and 400 mg Piracetam) 1000 tablets Ctticoline Sodium 531.888 gm 2. Piracetam 408.000 gm 2) This issues with the approval of competent authority. 6釘鵬億鯖 Phone.23323292 Email: barn. khast@nic.in Department of Com merce, (Shri Nirmal Kumar, Dy DGFT), Email: nirmal. kuma165@nic. in

彦 ⌒

Case No.: 16l13/82-Al-C1/2013 Party Name:GtJl-BRANDSEN Meet No/Dat e:t5t82- Status:Case

CIIEMICAI.S PVT l-'fD ALC4t20t3 Approvert 3I.r0.20t3 HQ File RI-A Filc l-ic.No/Date:3410037559 Deler Dare: ':0ll82l050l00492lAMl4l :34l24l}40t00O9UAMt4t 01.08.20t3 Decision : ln the light of written comments received from Department of Chemicals and Petrochemicals vide their U.o No. 74010149/2ottz/ch il dated 25.t0.20t3, it was decided to ratify norms 163 un6sl Para 4.7 of HBP v1 as per details glven below or as applied by the firm, whichever is less: Export Product 呻 Ｑ ｕ ａ ｎ ｔ ｉ S.No lmport Product Quantity Allowed EthylAluminiurl Dich loride(EA DC) l kg Alunr inium Grit/Granules 0.094 kg RA mav take action as per the decision appropriate of Norms Committee. ‐ ― ― ‘ ― 　 　 　 　 　 　 　 　 一

lζ ゝ F.No 35011ノ347/2014-PI(Norrns) Government oflndia Ministry of Chemical&Fertilizers Shastri Bhawan,New Delhi, Datedi March 10,2015 0ffice Memorandum Sub: Fixation of norrns under para 4.7 of Hand Book Of Procedures App‖ cation of M/S Gland Pharrna Ltd. The undersigned is directed to referto DGFT U.〇 .No.01/82ノ50ノ00026ノAM15ノDES… 3ノ280 dated the 15.05.2014 vide which an application fronl M/S Gland Pharrna Ltd. was fon″ arded tO thiS Department for fixation Of norrrls for the export Nadroparin CalCium lnieCtiOns in mo strengths and convey norrns as fo‖ OWS:― . 〃 |) Export producti― One pre¨ fi‖ed syringe of Nadroparin Ca:Ciurn !nieCtiOn (Low Molecular Weight Heparin)28501Uノ0.3nll:― Raw materials ffi Qty. recommended Ｓ ‐ ． Ｎ 。 26.125 rng 1.0534 Nos 2 Elarrol -Srrrinoes Needle Shield 1.0451 Nos. 3 1.1091 Nos. 4 Dlr rnnar Stonners Plunqer Rods 1.0294 Nos. 5 1.0500 Nos. 6 Drorrontiq, Anu― Factor Xa Test Kls Not admissible 7 Not admissible 8 Anti-trnntnr lla Test Kits Medical Grade Paper ___ luЫ ng Anfi_Fndor Xa ___ Not admiSSible 9 Not admissible 10 0.9 gram 0.02925 cms 12 Not admiSSible 13 An輛―FactOr lla K:ハ十nHrninQihlo 14 Not admissible 15 t\l L,t P Sfandarrl trlot. Wt. Standard Not admisSible 16 ii) Export producti― One pre‐fi!led Weight Heparin)57001U′ 0.6m::― -2- syringe of Nadroparin CalCium lnjection (Low Molecular .… 2/― Qty. recommended Raw materials arin Calcium

3 r Needle Shield 1.0451 Nos. 4 Plunger Stoppers 1.1091 Nos. 5 Plunger Rods 1.0294 Nos. 6 Preventis 1.0500 Nos. 7 AnI― Factor Xa ttest Ktts Not admissible 8 An輛…Factor‖ a Test Kits Not admissible 9 Analytical Columns Not admissible 10 Analvtical Guard Columns Not admissible Medical Grade Paper 0.9 qram 12 Tubing 0.02925 cms 13 AnJ… Factor Xa Not admissible 14 An‖―Factor‖ a Not admissible 15 N,M.R.Standard Not admissible 16 Mol.Wt.Standard Not admissible 2. This issues with the approval of Director (Pharma lndustry). (Barnali Khastgir) Phone:23385765 (Shri MVSingh,FTDO), Udyog Bhawan, New Delhi'

^ File No.35011ノ40′ 2016‐ P卜Norrns :、 F. No.3501 1 14012016-Pt (Norms) Government of lndia Departm ent of Pharm aceuticals Janpath Bhawan, New Delhi, Dated: November 21 . 2016 Office Memorandum Sub: - Fixation of norms under para 4.7- Application of M/s Emcure Pharmaceuticals Ltd. The undersigned is directed to refer to DGFT U.O. No. 011821050101809/AM-16/DES-3/04 dated 04t0412016 and subsequent letter from M/s Emcure Pharmaceuticals Ltd. for fixation of norms against export of Etomidate lnjection 20 mg/10m1 & 40 mg/20mlvials. This department has examined the matter and following norms are recommended against this applicatio n. 2. This issues with the approval of Director (Pharma lndustry). (Barnali Khastgir) Phone:23323292 Email: barn.khast@nic.in Directo rate General of Foreign Trade, Departm ent of Co m merce, (Shri Nirmal Kumar, Dy DGFT), Ema il: nirma l.kuma r65@nic.in リ Z7彎 Product to be Exported Raw materials to be lmported ・ 　 ０ Ｓ Ｎ Descript io n Quant ity ● 　 ０ Ｓ Ｎ Descript io n Quantity for 100 vials Etomidate lnjection 20mg/l0mlvials 1 00 vials 1 Etomidate [Relevant Bulk Druq) 2.20 gm 2 Serum Sto ppers 101 Nos. 2. Etomidate lnje ct io n 40mg/20mlvials 1 00 vials 1 Eto m idate [Relevant Bulk Drug) 4.20 gm 2 Serum Stoppers 101 Nos. Signatur :13:57 1ST

⌒ リワ静 ICase No.:35/23/82¨ Party NalnciBENZO IMCct No/Datci1/82- IStatus:case :ALC4/2013
‐CHEM INDUSTRIES
‐ALC4/2014 ,Approved l lPRIVATE LIMITED、 10.042014 1 Lic.No/Date:0310765141 1Defer Date: IHQ File lRLA File 101/82/050/01082/AⅣl14/ 103/94/040/00871/AM14/ 108.01.2014 1 1Decision:ln the light of wtttten comments received from Department of Chemicals and つ Ｊ ′ ● ′ Petrochemicals vide their U O No 14010/29/2011-Ch‖ dated 21.04.2014′ it was decided to | lratify norms under Para 4.7 of HBP vl as per details g市 en below or as applied by the nrm′ 1223 1WhiCheveris iess: Export product Exp. Qty. SI No lmport items Qty. allowed 2-CHLORO‐ 4.6-DI METHOXY-1、 3.5‐ 「RIハZINE CHLORDIMETHOXYTRIAZINE) l kg CYANURIC CHLORIDE 1.750 kg 2. SODIUM BICARBONATE 1 595 kg RA may

⌒ ζ00 F.No.35011/270/2016-PI(Norms) Government oflndia Ministry of chemical&Fertilizers ' Department of Pharmaceuticals Udy° ttlawttt:認,現|: Office Memorandum SubieCt:― Fixation of norms under para 4.7 0F Hand Book of Procedures(vOI.|)2009_14 Case of Ⅳ lノs Granules india Ltd. 鰍i齢!獲閣}罫群[佳露を闘軋認考胎亀淵餃 Rdi譜♀ふ |:l‖:1:需首 ilti:|:[:」 :lI:ξllThiξ d』l熱:L:11:ξ電設」需 「 [『1寵魚 :t腱|

para 4.7 of Hand B00k of Procedures(vOI.|)

2009-14:― S.No. lmport item Norms RecommGnded- for 1kg Export (6S)-6-[5¨ [7-[2-(lR,3S,4S)-2-Azabicyclo[2.2.1]hept… 3‐y卜lH_benzirnidazol-6-y11-9,9-difluoro-9H― fluoren-2- yl-lH― irnidazol-2‐ yl_5¨ azaspiro[2.4]heptane Hcl (1:4) 0.965kg 2 N―Methoxy carbonJ― LJaline 0.70kg Under Secretary to the Covernm:]]:ド需品 ! PH:-23071162 Udyog Bhawan, New Delhi.

場 iCase No.:20/13/82‐ IALC4/2013 the firm, whichever is less: 87 Pariv NanlciVARUN MEDIMPIEX INC Mcct No/Datc:9/82‐ ALC4/2014 20 1020i4 Strtus: a pprovetl Rl_A Filc HΨ 卜lle KLハr ilC しlしドυ′L/Or 101/82/050/00496/′ ヽヽ114/ 105/24/040/00134/AN414/ 210820!3 HQ File Decision:ln the light of written comments received from Petrochemical DiViSion of Department of Chemicals and Petrochemicais vide their U O No.46011/104/2009‐ PC― ‖dated 21.10.2014′ it was decided to ratify norms under Para 4 7 of HBP vl as per detans given below or as applied by E,xport product Iixp. Qt). SI No Inrpolt ite ms Qt1,. allorved Dettol Medicated Fabric Plaster Size l9 rnrnx65mtn l N0 l ヽVovcll D、′ cd I↑abric or l()()9る ′ 「c、ttlriscd l)olycsicr Filanlcnt,GSヽ4!15± 10% ()001320 Stl lヽ4ctcr NonヽVovcn Rolls.GSM 100 +159/6 0.000315 Sq ヽ4ctcr RA may take appropriate action as per the decision of Norms Committee'

雪守h= 一 (:::II:::]〉 暉人 ・娯血ifいA難 ろ|チ F. No.3501 1178912015-Pl (Norms) Government of lndia Shastri Bhawan,New Delhi, Dated:」uly 18,2016 0ffice Memorandum Sub:― Fixation of norms― Applicalon of A/1/s Jodas Expoirrl Pvt.Ltd.,New Delhi. The undersigned is directed to refer to DGFT U.〇.No.01/82/050/01025/AM16/DES― 3/1416 dated l1/01/201 6 fonJvarding an application of M/s Jodas ExpOirn Pvt.Ltd.for fixatiOn of norrns against export of Meropenern iniectiOn in l gm and 500 mg strengths.This department has exarnined the rrlatter and the fo‖ owing norrns are furnlshed:― t響 . Product to be Exported Raw materials to be lmported S.No Description & Pack Size Quanuty Description Quantity for 100 vials Meropenem inieC■Ons l gm 宙al 1 00 vials Meropenem Ttthydrate (Sterile Bulk) 125.501 gm 2. Meropenem :nieCtiOns 500 mg vial 1 00 vials Meropenem Ttthydrate (Sterile Bulk) 62.750 gm 2. This issues with the approval of Director (Pharma lndustry). (Raj Kumar) Phone: 2307 1 1 62lUspi3-Pharma@nic.in (Shri MVSingh,FTDO), Udyog Bhawan, New Delhi.

File No.35011ノ167ノ2016‐ PI‐ Norrns F. No.3501 1 1167 t2016-pt (Norms) Government of lndia Ministry of Chemical& Fertilizers Depart ment of Pharmaceut icals Janpath Bhawan, New Delhi, Dated: November 28, 201 6 Office Memorandum Sub: - Fixation of norms under para 4.7- Application of M/s Alembic Pharmaceut icals Ltd. The undersigned is directed to refer to DGFT U.O. No. 0118210501002171AM-17/DES-3/ dated 0810712016 and subsequent letter from M/sAlembic Pharmaceuticals Ltd. for f ixation of norms against export of Clarithromycin Entric Coated Granules 28o/o and 38% strengths. This department has examined the matter and following norms are recommended against this application. |ら 一ろZ) 2. This issues with the lndustry). Under Secretary to Depart ment of Commerce, (Shri Nirmal Kumar, DY DGFT), Email: nirmal.kuma165@nic.in approval of Director (Pharma (Barnali Khastgir) the Government of lndia Phone:23323292 Email: barn.khast @nic.in Signature Digitally KHAST( Date: S:. No. Description of Export product S:.No. Raw materials to be lmported per kg of export product Description Quantitv Clarithromycin Entric Coated Granules 28% Clarit hromycin 0 2828 kg 2. Acetone 1 05 kg 2 Clarithromycin Entric Coated Granules 38% Clarit hromycin 0 3838 kg 2 Acetone 1.05 kg Re :51:50 ハ

⌒ ニ 多蒻 丁断露F而戸群需琴 91 CrN;tlzAl0l8} IF"rtyN"""YASHO -- llrd."tNofp"t.,rOlS2- fstatus:Case iLC4/2013 IINDUSTRIES PVT.LTD. lALC4l20t3 lApproved I i22.os.2ot3 I HQ File --trA Ftl. pefer Date: :01/82l050/0030s/AMl4/ l:03t95t040t0t0t7tAMt3t 118.03.2013 I D..trt", r L th. light of *.itt.n ;i;;.*i"; frorn p"purtiof Cf,.rnituf.a.m.t i"uft vide their U.O No. 14010195/2011-Ch. II dated2.4.2013, it was decided to ratiff norms under Para4.7 of FIBP vl as per details given below or as applied by the firm, whichever is less: Export product ” 呻 Ｏ ｕ ａ ｎ ｔ ｉ S.No Import items Quantity Allowed ks/ke Methyl Eugenol l kg 1 Clove Leaf Oil(Eugenol Content 78%) 140 may take appropriate action as per the of Norms Committee. 「 |

^ ′ |ゝ ア′8 一 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 ４ 一 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 ４ ICase No.: IALC4ノ201 IHQ File i01/82/050/011 IRLA 103/〔 No.:39ノ46′82‐ Party NameiBENZO CHEM IMeet No/Date:10/82- ノ2011 lNDUSttRlES PRI∨AttE IALC4/2012 1LIMI丁ED, 05062012 一 ｅ 一 Ｓ 一 ａ ． ｄ 一 ｕ ｓ ｉＣ 　 ｒ ｏ ｖ ｅ 一 Ｓ ｔ ａｔ Ａ ｐ ｐ ILic No/Date1031 067373 1Defer Date: →Q File lRLA File 01/82/050/01255/AM12/ 1:03/94/040/00856/AM12/ 0 1 130122011 1 Decision i Decision : Committee considered case as per agenda and in light of written comments :o向varded by Deptt of C&PC vide their∪O No 14010/29/2011-Ch‖ dated 25 05 2012 decided to rajfy ηorms under para 4 7 of HBP as perdeta‖ s below or as applied by fi「m whicheveris:ower:― Export product Exp Qty SI No lmport items Qty. allowed 2,5-Dimethyl Phenyl Acetyl ch10nde l kg Para Xylene 1 485 kg 2 Paraformaldehyde 1 032 kg 3 Sodium Cyanide 0 570 kg 4 Caustic Soda Flakes 0 500 kg 5 Thlonyl Chlonde 0 980 kg RA concerned maY take further recessary action as per above decision of NC

ハ Paty Name:GITANJALI ICHEMICALS PVT LTD ノ≦ア ´5, IMcet No/Datei1 4/82- iStatus: IALC4/2013 1Approved 124 102013 1 1Lic No/Datei03 10744 138 1Defer Date: .05082013 1 Ｆ Ｉ Ｉ ICase No.:39/14/82- IALC4/2013 IHQ File iRLA File 101/82/050/00624/AM14/ :03/94/040/00264/AM14/ Decision: ln the light of written comments received from Department of Chemica:s and Petrochemicals vide their u.O No 14010/41/2011‐ Ch!l dated 28.10.2013′ it was decided to ratify norms under Para 4.7 of HBP vl as per detalls given below or as applied by the irm′ whichever is less: Export product Exp. Qty. SI.No. lmport items Qty. allowed 4-BROMO PHENETOLE DR 4-ETHOXY BROMOBENZENE l kg PHENOL 0.850 kg 2 CAUSTIC SODA FLAKES 0.470 kg 3. D卜ETHYL S∪LFATE 1.020 kg 4. HYDROGEN BROMIDE(48%) 1.380 kg 5 HYDROGEN PEROXIDE(50%) 0.630 kg RA may take appropriate action as per the decision of Norms Committee.

♭ ↑ F. No.3501 1178312015-Pl (Norms) Government of lndia Shastri Bhawan,New Delhi, Dated the August 22,2016 0ffice Memorandum Sutted λ[高:詳∬Ⅷl配:L』翫i燻鴇:留.B°° k d PЮcedttes Ⅳ d⇒2009-44 丁he undersigned ls directed to referto DGFT U.〇 .No.01/82/050/01378ノAAll-16ノDES― 3/502 dated 12/01/201 6 vide vvhich an appliCation from M/s Encube Ethicals Pvt.Ltd、 ″as sent tO this Department fOr fixation of norrns for the export of 31 type of packs of ointrnents/creams. 2) The matter has been examined and all these 31 export products have been categorized in 17 groups of ointments under different brands/generic formulations. The norms for each of the categori"s for different pack sizes have been worked out based upon DML' Batch Formula and sloN published for this type of formulations. The quantities of different inputs for 100 tubes of different pack sizes of specific composition of formulations as given below may be considered aS input Output norrns forthe export products covered underthis application. S.N 0 Name of Export Product Ｎ Ｓ ） ０ -lnputs recommended 100 tubes of14 gm 100 tubes of 42 gm 100 tubes of28 gm 1 Miconazol 2% e Creams in different pack sizes Benzoic Acid 0.28 gm 0.84 gm 0.56 om 2. Peqoxvl 7-stearate 280 gm 820 gm 560 om 3. Mineral Oil 42 gm 126 gm 84 gm 4. O leoyl P o I Yoxylglygql!! e!- 42 qm 126 gm 84 qm 5. Butvlated hYdroxYanisole 0.0728 gm 0.2184 gm 0.1456 gm 6. Miconazole 28.56 gm 85.68 gm 57.12 gm 7. Empty Laminated Printed tubes of corresPonding sizes As per Packing PolicY -lnputs recommended 100 tubes of 45 gm with 1 applicator 100 tubes of 45 gm with 7 applicators Ｎ Ｓ 　 ｏ Name of Export Product Ｎ Ｓ ） ０ 0,900 gm 0.900 gm 2. Miconazole 2o/o Creams Benzoic Acid 2. Pegoxyl 7-stearate 900 gm 900 gm 3. Mineral O‖ 135 gm 135 gm 4. … dyOXゾgl… 135 gm 135 gm 5 Butylated hydroxyanisole 0.234 gm 0.234 gm 6. t\Iinnnaznle 91.80 gm 91.80 gm As per Packing PolicY 7. EmptY Laminated Printed trrhes of corresoondinq sizes 8. 1 or 7 aPPlicators as Per product sPecification 100 packs of one applicator each 100 packs of Seven applicator each

-2- S.No Name of Export Product S.No lnputs recommended 100 tubes of 14 gm 100 tubos of28 gm 3 Clotrimazole 1% creams Cetostearyl Alcohol 140 gm 280 gm 2 Octyldodecanol 189 gm 378 gm 3. Cetyl Esters 33 gm 66 gm 4. Sorbitan Monostearate 28 gm 56 gm 5. Polysorbate 60 21 gm 42 gm 6. Clotrimazole 14.28 gm 28.56 gm 7. BenzylAlcohol 14 qm 28 gm 8. Sodium Phosphate Monobasic 2.24 gm 4.4gm 9. tubes of corresponding sizes As per Packing Policy S.No Name of Export Product S.No lnputs recommended 100 tubes of45 gm with l applicator 100 tubes of 45 gm with 7 applicators 4. Clotrimazole 1% creams Plastic (LDPE) Applicators (1s or 7s packs) (100 pack of1 applicator each) (100 pack of 7 applicators each) 2. Cetostearyl Alcohol 450 om 450 gm 3. Octyldodecanol 607.500m 607.500m 4 Cetvl Esters 135.00 gm 135.00 gm 5. Sorbitan Monostearate 90.00 gm 90.00 gm 6. Polvsorbate 60 67.50 om 67.500m 7. Clotrimazole 45.00 gm 45.00 gm 8. BenzvlAlcohol 45.00 om 45.00 gm 9. Sodium Phosphate Monobasic 7.20 gm 7.20 gm 10. tubes of corresponding sizes S.No Name of Export Product S.No lnputs recommended 100 tubes of 14 gm 100 tubes of28 gm 5 Triple AnJbiotic Ointment 1 White Petrolatum Quantity not indicated in the Batch formula 2. Polymyxin B Sulfate (non-sterile) 7.14 MU 14.28 MU 3. Bacitracin Zinc 7.22 gm 14.14 gm 4. Neomycin Sulfate 4.998 9.996 gm 5. tubes of corresponding sizes

-3- S.No Name of Export Product S.No lnputs recommended 100 tubes of 14 gm 6 Triple MS Antibiotic Ointment White Petrolatum Quantity not indicated in the Batch formula 2. Polymyxin B Sulfate (non- sterile) 28.56 MU 3. Bacitracin Zinc 18.05 gm 4. Neomycin Sulfate (micronized) 9.996 gm 5. tubes of corresponding sizes S.No Name of Export Product S.No lnputs recommended 100 tubes Of28 om 100 tubes Of14 gm 7. 丁riple Antibiotic Ointment 1/V/PRAM White Petrolatum 277.6032 gm 138.8016 gm 2. Pramoxine HCL 28.56 gm 14.28 gm 3. Bacitracin Zinc 18.05 gm 9.025 qm 4. Polymyxin B Sulfate (non- sterile) 14.28 MU 7.14 MU 5. Neomycin Sulfate (micronized) 571.2gm 285.6gm 6. tubes of corresponding sizes S.No Name of Export Product S.No lnputs recommended 100 tubes of56 gm 100 tubes of14 gm 100 Tubes of28 gm 8 Triple Antlbiotlc Ointment EF Cocoa Butter Ultra Natural 2.5 gm 63 gm 126 gm 2. White Petrolatum Quantity not indicated in the Batch formula 3. Super Refined Cottonseed 238 gm 59.5gm 119 gm 4. Super Refined Olive- LQ 14 gm 3.5gm 7gm 5. Vitamin E Acetate 126 gm 31.5gm 63 om 6. Polymyxin B Sulfate (non-sterile) 14.44 MU 3.61 MU 7.22 MU 7. Neomycin Sulfate (non-micronized) 19.992 gm 4.998 gm gm 9.996 gm 8 Bacitracin Zinc 28.88 gm 7.22 14.44 gm 9. Empty Laminated Printed tubes of corresponding sizes

-4- S.No Name Of Export Product S No lnputs recommended 100 tubes of14 gm 100 Tubes of28 gm 9 Double Antibiolc W/PRAM Cream Emulsifying wax 168 gm 336 gm 2. Mineral O‖ 112 om 224 gm 3. White Petrolatum 56 gm 112 gm 4. Poloxamer 188 0.0182 gm 0.0364 gm 5 Propvlene Glvcol 28 gm 56 gm 6. Methyl Paraben 3.5gm 7.00 gm 7. Polymyxin B Sulfate (non- sterile) 14.28 gm 28.56 gm 8. Neomycin Sulfate (micronized) 4.998 gm 9.996 gm 9. Pramoxine HCL Micronised 28.56 gm 14.28 gm 10. Empty Laminated Printed tubes of corresponding sizes S.No Name of Export Product S.No lnputs recommended 100 Tubes of 28 gm 10 Allergy W lZinc Cream Cetyl Alcohol 448 2. Polvsorbate 60 84 3. Sorbitan Monostearate 196 4. Propvlene Glycol 140 5. Methyl Paraben 7 6 Diphenhydramine Hydrochloride 57.12 7. Zinc Acetate 2.856 8 Empty Laminated Printed tubes of corresponding sizes As per Packing Policy S.No Name of ExPort Product S.No lnputs recommended 100 Tubes of14 gm 100 Tubes of28 gm Double Antibiotic Ointment whne PetrOlatum Quantities could not be worked out as neither the DML nor Batch Formula provided in the application. 2. Polymyxin B Sulfate (non- Sterile) 3. Bacitracin Zinc 4. tubes of corresponding sizes A

-5- S.No Name of Export Product S No lnputs recommended 100 Tubes of 14 gm 100 Tubes of28 gm 12 Bacitracin Zinc Ointment 1 White Petrolatum Quantity not indicated in the Batch formula 2. Bacitracin Zinc 9.025 18.05 3. tubes of corresPonding sizes / あドS.No Name of Export Product S.No lnputs recommended 100 Tubes of28 gm 100 Tubes of56 gm 13 Hydrocortisone l% OTC Cream Glyceryl Stearate The requirement of various inputs not tally with Batch Formula and DML available in the application. 2. VVhite wax 3. Stearvl Alcohol 4. lsopropyl MYristate 5. Cetvl AlcohOI 6. Sorbitan Monostearate 7. Polysorbate 60 8. Propyl Paraben 9. Anhydrous Citric Acid 10. Sodium citrate Methyl Paraben 12. sorbic Acid 13. PolvOXy1 40 Stearate 14 Propylene GlYcol 15. Hydrocortisone 16. tubes of corresPon@g rggq 100 Tubes of28 gm lnputs recommended Name of Export Product Whle Petrolatum Hydrocortisone l% OTC Ointment Mineral()il As per Packing tubes of corres

-6- S.No Name of Export Product S.No Inputs recommended 100 Tubes of28 gm 100 Tubes of56 om 15 Hydrocortisone/ Aloe 1o/o Cream Anhydrous Citttc Acid 0.98 gm 1.96 gm 2. Sodium citrate 1.68 gm 3.36 gm 3 Methyl Paraben 5.6gm 11.2gm 4. Sorbic Acid 1.4 qm 2.8gm 5 Polvoxyl 40 Stearate 14 qm 28 gm 6 Propvlene Glycol 98 om 196 gm 7. Glvcervl Stearate 56 gm 112 gm 8 VVhite vvax 84 gm 168 gm 9. Stearyl Alcohol 28 gm 56 gm 10. lsopropyl Myristate 224 gm 448 gm Cetvl Alcohol 84 gm 168 gm 12. Sorbitan Monostearate 84 gm 168 gm 13. Polysorbate 60 84 gm 1680m 14 Propvl Paraben 2.8gm 5.6gm 15. Hydrocortisone 0.02856 gm 0.05712 gm 16 Aloe Concentrate 2.8om 5.6gm 17. tubes of corresPonding sizes S.No Name of Export Product S.No lnputs recommended 100 Tubes of28 gm 16 Hydrocortisone Plus 12 Cream Anhydrous Citttc Acid 0.980 2. Sodium citrate 1.680 3. Methyl Paraben 5.600 4. Sorbic Acid 1.400 5. Polvoxv1 40 14.000 6. Propylene Glycol 98.000 7. Glycerin 7.000 8. Glvcervl Stearate 56.000 9. White wax 84.000 10. Stearyl Alcohol 28.000 lsopropyl Myristate 224.000 12. Sorbitan Monostearate 84.000 13. Polvsorbate 60 84.000 14. Propyl Paraben 2.800 15. Mineral O‖ 7.000 16. White Petrolatum 7.000 17. Cetosteryl Alcohol 7.000 18. lsopropyl Palmitate 2.800 19. ∨itamin A&D3 7.000 20. Aloe COncentrate 2.800 21 Hydrocortisone 28.560 22. Cetyl Alcohol 84.000 23. Empty Laminated Printed tubes of corresponding sizes

‐7- ● 　 ０ Ｓ Ｎ Name of ExPort Product S,No lnputs recommended 100 Tubes of 56 gm 17. Hydrocortisone 0.5% Cream Methyl Paraben 0.112 gm 2. Sorbic Acid 0.056 gm 3. Polvoxvl 40 Stearate 0.280m 4. Glvcervl Stearate 1.12 gm 5. White wax 1.68 gm 6. Stearvl Alcohol 0.56 gm 7. lsopropvl Myristate 4.48 gm 8. Cetyl Alcohol 1.68 gm 9. Sorbitan Monostearate 1.68 gm 10. Polvsorbate 60 1.68 gm Propyl Paraben 0.056 gm 12. Propylene Glycol 1.12 om 13. Hvdrocortisone 0.28 gm 14. tubes of corresponding sizes As per Packing Policv 3. This issues with the approval of Director (Pharma lndustry). (Raj Kumar) Phone: -23071162 Email: - uspi3-Pharma@nic.in Directorate(3enera1 0f Foreign ttrade, Depanment of COmmerce, 器y計鼎 :llξ∬匙 lhi

ハ 翼11:iラノ解 216 Cr* Nr"6IAl82+,LC4l2013-[p"nv N"r*,YesHo ----lMt N"/DutiAtn- - Istrtr.cr ilNousrntes pvr.LTD. lALC4t2ot3 l.lpproved I 113.06.2013 I HaFl. IRLAFTT. @tD.fDrt" :01/82/050/00t02lAMl4l l:03/951040/01003/AMl3/ I13.03.2013 I Daatttm n,,h.{gh d P..".1,.r""1t vide their U.O No. l40l0l95l20l1-Ch. II dated 10.06.2013, it was decided to ratifo norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less: Item of Export Ouantitv S、No Item of Import Ouantity allowed BUTYLATED HYDROXY ANISOLE (BHA) l kg 1 HYDROQUINONE 1.247 kg 2. TERTIARY BUTANOL 0.839 kg PHOSPHORIC ACID 1 00 kg 4. HEXANE 1.00 kg RA may take appropriate action as per the decision of Norms Committee.

lゝ g_q静 F. No.3 50 | 1 127 21201 3-PI (Norms) Government of India Departrnent of Pharmaceuticals lJdyog Bhawan, New Delhi, the)4tt June, 2013 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1)

2009-14 Case of M/s. Neuland Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011148/AM13/DES-311305 dated the 18103113 vide which an application from M/s, Neuland Labs Ltd was sent to this Department for fixation of norms under para: 4.7 for iire export of Besifloxacin Hcl. This department has examined the matter and the following norms are furnished under para 4.7 of Hancl Book of Procedures (Vol.l) 2009-14 - S.No. Imporl Item Qty. Recommended kg/kg. D-Lysine Hydrochloride 6.10 つ 一 2-Chloro-4, 5 -Difl uorobenzoic Acid 9.18 3. Lithium Aluminiurn Hydride 3.78 2. This issues with the approval of Director (Cost). (Raj Kumar) Under Secretary, to the Government of India PI-Norms (Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi.

lf アタレダ礎ト ёlζしヽ61七′ijjふALむ4′,bib i島●ヽ:鳥ど百ENZO ёttЁM IMもまヽ3'5,18:'シ821 1ζ ttζ:ё :I‐ : 1 lNDUSTRIES PRIVATE IALC4/2013 :Approved i l lLIMITED, 120.022014 1 : IHQ File lRLA File :Lic No/Date:0310748569 1Defer Date: | 101/82/050/00768/AM14/ 1:03/94/040/00388/AM14/ 105092013 : : :Decision:ln the‖ ght of wtttten comments received from Department of Chemicals andi Petrochemicals vide their U.O No.14010/29/2011/Ch ll dated 03.032014′ it was decided to lratify nOrms under Para 4.7 of HBP vl as per details g市 en below or as applied by the irm′ 176 1whicheveris less: Export Product Export Quantity S.No lmport Product Quantity Allowed 2 Amino 2 Phenyl Butyric Acid l kg 1. Propiophenone 1.082 kg 2. Methanol 0.792 kg 3. Sodium Cyanide 0.490 kg 4. Caustic Soda Flakes 1.230 kg Ｆ 一 ,nA ,.y trt e ,ppropriate action as per the decision of Norms Committee.

毎 r∠ I Casc No.:91/1/82-ALッC4/2013 Party Nalnlc:KUBO Mcet No/Date:1/82- Stattis:Case COMBUS′r10N EFFICIENCY Al_C4/2013 Approved CHEMICAlッS PVT LTD 04.04.2013 t illLA/11tン /ヽ1ッbi″ VI Lilり U4.U4.Zt'Ij HQ Filc RLA Filc Lic.No/Date:0310724423 1DeFer Datc: :O1/82/050/O1449/AM13/ :03/94/040/00899/ノ ｀M13/ 18.02.2013 Decision : In the light ol'rvritten comments receivecl from Department of Chemicals ancl Petrocl'remicals vide their LJ.O No. 1401011012009-Ch. II dated 16.4.2013, it u,as decided to ratily nonlts Ltncler l'ara 4.7 ol' I-lBP r, 1 as per details given below or as applied by the firm. whichever is less: Export Product Export Qty. SI No lmport items Qty. allowed Kubochem-40'1 (Diethyl ketone or 3- Pentanone) l kg 1 Proplonic Acid Purlty 99 0% Mln 1 92 kg may lake appronriate action as 288 appropriate action as pcr the clecision of Norms Committee. ty

′ ( 辮 η) ⌒ 「 |.κ κ J^.NM@@frt*'cr* lrNousrrues PVT. LTD, lALc4t20t2 lApproved I l2t.o3.2ot3 I HaFle ffi@F.ft.D"t" 0l/82/050/0l232l\Mt3l l:172afi40100065/AMl3/ |124.0t.2013 I Decision :In the light of earlier decision taken in meeting no.42182 dated 17.l.20l2,it was decidedto ratify norrns under Pua 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product ExpOrt Qty. SI.No. lmport items Qty. allowed PRODUCT LAP-2 (Phosphated Ester of Lauryl Alcohol 2 mole ethoxylate) l kg １ ２ ３ LaurylAlcohol Ethylene oxide Phosphorous Pentoxide 0.585 kg O.268 kg O.148 kg may take appropriate action as per the decision of Norms Committee.

lf 鴛 …仙れ…孵珈‰,M"町 器3児50/001口晨m″ 賠ち鵬01∞"1叩 ν 圏 郷 酬 ・ T“ 29 PebDttα ２ ０ ‐ ‐ ‐ ‐ つ Ｆ ‐ ‐ ‐ ‐ ― ― ― ― ― ― ― Decision : In the light of earlier decision taken in meeting no.49182 dated 8.3.2011, it was decided to ratify noflns under Para 4.7 of HBP vl as per details given below or as anolied bv the firm. whichever is less: Export Product 威 帥 Ｑ ｔ ｙ ． S:.No. lmport items Qtv allowed Product ASO-1315(Tndecyl Alcoho1 1 5 Mole Ethoxylate) l KG Ethylene Oxide 0.767 kg 2. TridecylAlcohol (lso Tridecanol) 0.232 kg RA may take appropriate action as per the decision of Norms Committee.

lS_ ζら森 F. No.350 1 | I 635 12015-PI Qllorms) Govemment of India Ministn,of Chemical & Fenilizers Depafiment of Pharmaceuticals Ncw Dclhi.the Udyog Bharvan. Decerlber'- 201,5 Office Memorandum Strbject: - Fixation of norms under para4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s Danopharnt Chemicals Pvt Ltd. The undersigned is directed to refer to DGFT U.O.No. 0l/82l501773lANI-16/DES-3/813 dated the 20/08115 vide ',vhich application from M/s. Danopharm Chemicals Pvt Ltd was sent to tlris Department for fixation of norms ulder para: 4.7 for lhe export of 4-Sulphonamido Phenyl Hydrazine Hcl. This department has examined the matter and the following norrns are ftrrnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:' S.No. Import Item Qty. Recommendeci ttg/iig. 1 Sulfanilamide 1.01 つ 一 Sodium Nitrite 0.40 う Ｄ Sodium Bisulphite 1.10 4. lsopropyl Alcohol 0,75 5. Activated Carboir 0.100 2. This issues r,vith the approval of competent authority. (Raj Kumar) Under Secretary to the Government of india Phone:23071162 Directoratc Gencral ofForcign Tradc, Dcpatment of Corlmlercc, (Sllri M.V.Singh,FTDO), Udyog Bhawan,Nc、v Dclhi

tc- F. No.350 11t7st2016-pt (Norms) 3 1k Government of lndia Ministry of Chemical & Ferlilizers Dated: July, 2016 Office Memorandum

subject: - Fixation of norms under para 4.7 of Hand Book of procedures (Vol.l) 2oog-14

case of M/s DSM sinochem phamaceuticats lndia pvt. Ltd. The undersigned is directed to refer to DGFT U.o.No. 01l}2t5ot201/AM-17/DES- 31270 dated the 817116 vide which application rrom Mls oSM Sinochem pharmaceuticals lndia Pvt' Ltd. was_s.gnt]o this Department for fixation of norms under par a,. 4.7 for the sxport of Amoxycillin Trihydi-=te through 6-APA route through Enzymatic route. This department has examined the matterand the following norm-s are furnished under

para 4.7 of Hand Book of procedures (Vol.l) 2OOg_14._

Under Secretary to the cor"rnr$f'ji,ffi? PH:- 23071162 Udyog Bhawan, New Delhi. lmport item 6-amino penicillanic acid (6-ApA Elcolase (Enzyme D(-) P-hydroxy phenyt gtycine methil ester 0.471kg

| :Case No.:78/14/82‐ ALC4/2013 P(lrty Nanlc:CAMPHOR& AI´LIED PRODUCTS IンIMITED, Mcct No/Date:16/82‐ AI´C4/2013 21 112013 Status:Case Approvecl ‐HQ File RLA File lッ ic.No/Date:03!0735992 :01/82/050/00663/AN414/ :03/94/040/00120/AM14/ 129.05.2013 =| Decision: ln the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 140L0/20/2011-Ch ll dated 22.tt,2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is ,o less: Export product Exp. Qtv. SI No lmport items Qty. allowed ASTROM∪SK CONCENTRATE 1kg ISOAMYLENE 0 580 kg 2. PROPYIンENE OXIDE 0.380 kg 3. ALPHA METHYIンSTYREN E 0.769 kg 4. PARAFORMALDEHYDE 0.117 kg RA may take appropriate action as per the decision of Norms Committee. ― ― 一 一 -1 Defcr Date: 場 ノク゛乙

イ エ F. No.3 5 0 1 I I 597 12012-PI (Norms) Government of India Ministry of ChemiCal & Ferlilizers Deparlment of Pharmaceuticals

W -3( Udyog Bhawan, New Delhi, the 06th February, 2OI3 Office Memorandum

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

2009-14 Case of M/s. Nectar Lifesciences Ltd. The undersigned is directed to refer to DGFT u.o.No. 0ll82l50l444lAl'll3lDEs-3/644 dated the 29108112 vide which an application from M/s. Nectar Lifesciences ttd was sent to this Department for fixation of norms under para: 4.7 for the exporl of Cefepime for injection. This depaftment has examined the matter and the following comments are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S. No. Import Item Qty. Recommended kg/kg. 1 Cefepime Hcl Non Sterile 0.655 つ ４ -Arginine 0.37 う Ｄ Acetone (89.6% Rec.) 1.816 4. N/1ethanol 0.742 5. Eno carbon 0.034 2. This issues with the approval of Director (Cost). (N.N.Ahuja) Section Officer PI-Norms (Mrs. Lahta Maini, FTDO), Udyog Bhawan, New Delhi.

F. No.350 1 1 181912015-Pl (Norms) Government of lndia Dated: 5, May 2010 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. 01lB2l50l1443tAM- 16/DES-3/1421 dated the 1111116 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 Azithromycin Dihydrate. This departmcnt has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14:- S,No. lmport ltem Norms Recommended for 1kg Exporl 1 Azithromycin amine 1.00kg 2 Acetone 0 90kg 2. (Ralkumar) Under Secretary to the Government oflndia PH:-23071162 Depaftment of Commerce, ネーば

f 堵2ク F. No.350 1 I 13001201 3-PI (Norms) Government of India Ministry olChemical & Fertilizers Department of Pharmerceutical s Udyog Bhawan, New Delhi, the 24tl'June, 2013 Qffise Menlprcpduni Sub.iect: - Fixation of norms under paru 4.7 of Fland Book of Procedures (Vol.l) 2009-14 Case of M/s. Cadila I{ealthcare Ltd. The undersigned is directed to refer to DGFT U.o.No. 0ll82l50l1277lAMl3IDES-311275 dated the 18103/13 vide which an application frorn M/s. Cadila Flealthcare Ltd was sent to this Department for fixation of norms under para: 4.7 for the exporl of Galantamine Hydrobromide 4 mg, 8 ffi8, & 12 mg Tablets. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S.No. Import Iter-r'r For I No.Galantamine Tablet. 4m2 8m2 12 mg 1 Galantarnine IIBI{ 5.2285 mg 10.458 rng 15.687 mg つ 一 Bottles & Caps Relevant, As per packing policy. 2. This issr-res with the approval of Director (Cost). (Raj Kumar) Under Secretary, to the Government of India PI-Norms (Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi.

Ч長3 F. No.350 1 1 1201 12016-Pl (Norms) Government of lndia Dated: August, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) ZOO1-14

Case of M/s Morepen Labs Ltd. The undersigned is directed to refer to DGFT U O.No. 01l\2l50l221\AM-17IDES- 31302 dated the 1317116 vide which application from M/s Morepen Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Atorvastatin C=!cium. This department has examined the matler and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.r) 20og-14.- 2. (Rajkumar) Under Secretary 10 the Government ofindia PHi-23071162 Udyog Bhawan, New Delhi. S.No lmport item Norms Recommended for 1kg Export 1 (4R-cis)- 1, 1 -d imethyl ethyl-6-cya nometh y12,2- d imethyl- 1, 3-d ioxane-4-acetate 0.708kg 2 4-fluoro-alph a-[2-methyl- 1 -oxopropyl]-gamma- oxo-N-beta-diphenyl benzene butanamide 0.994kg 3 Methanol 4.285kg 4 Methyl tert― butyl ether 1.145kg 5 fgl1qhydrofuran 0.542kg 6 Methyle[e chloride 1.414kg 7 Diisopropyl ether 0.754kg

^ だ I S づ

Case No.:133/r1/82‐

AlンC4/2014 HQ File Sta tus:Approt,ed Rl´ A Filc I´ ic NO/Datc105!0382643 Deler Date: 101/82/050/00535/Aヽ415/ :o5/24/040/00487/Aヽ414/ 25032014 Decision : ln the light of written comments received from Department of chemicals and petrochemicals vi.l6 rhdi. ll n il^ lr^r^/..l1^i^t-
Party Nanle:PARAMOUNT Mect No/Date:l1/82‐ AROMACHEM PVT LTD、 ALC4/2014 26!12014 RA 219 vide their u o No 14010/61/2010/Ch‖ dated 28 11 2014′ it was decided to ratify norms under Para 4 7. Of H8P vl as per detalls given below Or as applied by the firm′ whichever is less: | Export Product Export Quantitv lmport Product Quantity Allowed ―CARヽ`ON[: l kg lり‐し:MONENE(LIMONENE, C「FRUS TERPENE,ORANGE TERPENE.BRAZALIAN CITRUS TERPENE STANDARD CITRUS TERPENE ORANGE OIし) 2 50 kg may take apprOpnate actiOn as pさrthe deds on of Norms

″ ケ HQ F‖e RI´ AF‖c lンic No/Datei03 1 0752448 Defcr Datc: :01/82/050/00592/A N74 1 4/ :01/82/050/00592/A N74 1 4/ :o3/94/040/00478/Aヽ414/ 07 102013 n^^:^:^_ ^ 1^ ェL_ l,_1. r
・
´ Decision : ln thO ‖ght Of llvritten comments received from Department of chemicals and Petrochemicals vide their∪ o No 14010/20/2012-Ch‖ dated 22.11.2013′ it was declded to ratify norms under Para 4.7 of HBP vl as per detalls g市 en below Or as applied by the lrm′ Export product Exp Qty. SI No lmport items Qty. allowed ASTROMUSK CONCENTRATE (Astronlusk colltcnt 10096) 1kg ISOAMYLENE 0 580 kg 2. PROPYL′ ENE OXIDE 0.380 kg 3. ALッPHA METHYL STYRENE 0.769 kg 4. PARAFORMALDEHYDE 0 117 kg RA may take appropriate action as per the decision of Norms committee.

Case No.:7/14/82-A LC4/2013 Pally NanlciCAMPHOR&

ALLIED PRODUCTS Mect No/Datc:17/82‐ AlンC4/2013 05 12.2013 Status: Case Approved

F. No.350 1 1 181912015-Pl (Norms) Government of lndia \q-T Dated. 5, May 2010 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 01lB2l50l1443tAM- 16/DES-311421 dated the 1111116 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 Azrthrcmycin Dihydrate. This department has ex=rlned the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14:- S.No. lmport ltem Norms Recommended for 1kg Export Azithromycin amine 1.00ks 2 Acetone 0.90ks 2 (Rajkumar) PH.._ 23071162

権 t'to/Orte,OS/SZ- Name:GLOBAL CALCiUM LlMlTED′ 赫 2‐ALC4ノ2009 ノAM10/ 4ノAM10/ 碁 黒II::::::: 1:ti苧三二 li:「:i]:][]][]『i電 ::累点 :里1即 ・諄"°i記1lr∬1器∬leltt」 concgnedl壼煙理製堅製鰹塁塁翌鰹塁型二重聖1豊 ヽ キ ー ハ ■ キ ー へ3ブ

F. No.3501 U63212015-PI Q\lorms) ! sa Government of India Ministry' of Chemical & Ferlilizers Departrnent of Pharmaceuticals Udyog Bhawan. Ne,,r' Delhi. the December. 2015 Otfice Memorandum

Subject: - Fixatior-r of nornrs urder para4.7 of Hand Book of Procedures (Vol.l)2009-14 Case of

M/s IPCA Labs Ltd. Tlre undersigned is directed to refer to DGFT U.O.No. 0118215017121 AM-16/DES-3/81 8 dated the 20108/15 vide'"vhich application from M/s. IPCA Labs Ltd was sent to this Department for fixation of norms uuder para:4.7 forthe export of Metoprolol Succinate. This departmept lras examined the matter and the follo"ving norrns are ftlrnished under para 4.7 of Hancl Book of Procedures (Vol.l) 2009-1 4:- S.No. Irnport Item Qty. Recommended kg/kg. 1 Para MethOxy EthyIPheno1 0r 4- ⅣIethoxy EthyI Pheiol 0.7951 つ ４ pichlorohydrine 0.6179 D Succinic Acid 0.4505 4. Mono IsopropylAmine 0.6284 2. This issucs、vith the approva1 0f compctent authOrity. UndcrSecretarytOtheGovernfIIII:II『|! Phone:23071162 DirectOratc Genera1 0f Foreign Trade, Dcpalment of COllmlerce, (Sllri M.V.Singh,FTDO), Udyog Bhawan,New Delhi | |

レ 資 紳 ダ 　 ， ι句 ⌒ Party Name:YASHO :NDUSTR:ES PVT.LTD. No/Date:5/82- ALC4/2010 04.05.2010 Status:Case Approved Decision:cOmmittee considered case as per agenda and in light Of written comments fOrwarded by Department of c&Pc vide their u.o, No.14010/120/2007/Ch.‖ i dated o7.07.2008 and in cOnsultation with technical authOrity present in meeting′ decided to ratify norms under para 4.7 of HBP as per below or as applied by firm whichever is lower:_ Export product ｐ Ｖ Ｅ ｘ Ｑ ｔ Si.No. lmport items Qty. allowed ｄ ｅ ｔ ｙ ‐ ａ ｔ ｉ ｓ ｏ ‐ ｅ ｕ 　 ｎ Ｂ Ａ Hydroxy l Kg, Hydroquinone 1.247 kg 2. Tertiary Butanol 0。839 kg 3. Phosphoric Acid 1.00 kg 4. Hexane 1.00 kg RA concerned may take further necessary action as per above decision of NC. HQF‖ e RLA F‖ e Lic.No/Date:0310564712 :01/82/050/00065/AMl1/ :03/95/040/00820/AM10/ 15.03.2010

IE ,/-ut61- Ir. No.350 I I15391201 3-PI (lrJorrns) Covernmerrt ol'lnclia I\4 inistrl, of Chemical & Fertilizers Departrlent of Pharmaceuticals tJdyog Bhawan, New Delhi, the 26th September, 201 3 OI'llce Memorandum Sub.iect: - Fixation of'norms under para 4.7 ol'l-iancl []ool< of Procedures (Vol.l) 2009-14 case ol'M/s Cadila I-lealthcare I_rcl. Thc undersigncd is directed to rcたrtO DGFT U.O.No.O1/82/50/141/AM14/DES‐ 3/300 dated the 26/07/13 vide、vhich l・epresentatiOn fl・Onn M/s.Cadila Healthcare Ltd was sent to this DepalTeTl br ЯXγ i° n,9f n°HllS un,er para:4・7%r the cxport Of venlaね対ne.This department has cxamined the mattcr and thc・ fOl10wing nornls ale ttlliJed」「品 i「::菖・ 4.ウ =:i Hand Book 01｀ Pl・Occdヒlrcs rヽ/。||ヽ,000_14・ (Raj Kumar) Under Secretary to the Government of India Directorate ceneral of Foreign -lrade, PI-Norms Department o I' Com merce, (Shri R.C. Meena, Dy. DGFT), Udyog Blrawan, New Delhi. pll'「Occdurcs(VOI.|)2009_14:‐ S.No. Import Itern Iror Ilxport of lNo. Tablets (ety. in Mg) 25me table ts 37.5rng tablets 50Jne tablets 75m2 tablets l00me tablets //1 Venlafaxine Hcl 28.855 × ().0 43.283 57.71 86.565 l15.42 つ ４ 鸞賛MOl1011ttC 45.0 60.0 90.0 120.0 つ つ ＼ 16.663 ＼ 33.325 49.988 66.650 4. 16.463 24.694 ゝ ぐ .388 65.850 5. iVitt311CSIulnl btcarate ＼ |.50 2.00 3.00＼ 4.00 ＼ 6. tarcll υlycolate 7.50 |ゝ 型 0 22.50 30.σじ、 7. a ro o) l,ackrng Material Relevant, A per pack†けgJttdic y. 2. This issLres with the approval of Director (Cost). は 師d円 祐雰呻洲山M

わ ‐Case No.:39/19/82-ALC4/2013 Party Nanlc:CAMPHOR& Meet NO/Date:19/82- IStatlls:Casel . A LlンIED PRODUCTS ALC4/2013 Approved ‐ Llヽ41´FED, 0201.2014 1 Lic.No/Date:0310748582 1Defer Date: HQ Filc RIンA File :O1/82/050/00984/AM14/ :03/94/040/00477/AM14/ 05.09.2013 1 1 :O1/82/050/00984/AM14/ :03/94/040/00477/AM14/ 05.09.2013 1 1 Decision : ln the light of written comments received from Department of Chemicals andl Petrochemicals vide their u.O No.14010/20/2012‐ Ch‖ dated 29.10.2013′ it was decided tol retroclltlH‖ tdlゝ V:uじ 、Ilt」ll υ .V INυ ・ ■■υ 工υ ノ乙υ /4υ ■4~し:i :l u Clヽ 「 v 4ノ ●4V●ι V‐ ψ ′ :し 'VЧ υ Y｀ ‐ '‐ ‐ ‐ ヽV l17 ratify norms under Para 4.7 of HBP vl as per deta‖ s given belovv or as app‖ ed by the firm′ whichever is less: lc、′^^二～^涎`:´+ lE、′去 I Ci卜|ハ !lmnλ ユ撃:|。mc l∩ h′ niini^′ 。バ | Export product Exp. Qty. SI No lmport items Qty. allowed CAMPHOR TECHNICAl´ l kg Al´PHA PINENE 1.146 kg RA may take appropriate action as per the decision of Nornrs Committee.

⌒ ′ダ 一争刊 :Lic No/Datc:0310703114 ‐25072012 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. I4010110712012-Ch.Il dated 29.10.2012, it was decided to ratify norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, r is less: may take appropriate action as per the decision of Norms committee. :03/95/040/00035/AM13/ :01/82/050/00643/AM13/ Export product 恥 餌 SI No lmport items Qty. allowed SDPA (Styrenated Dト Phenviamineヽ l kg Di-Phenylamine 0 547 kg

19 ---'- t'tg
f?-+<-- F. No.350i 1t739t2015_Pl (Norms) Government of lndia Depa rtment of pharmaceutica ls Dated: 23 Februa ry,2016 Office Memorandum

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

14 Case of M/s Glenmark pharmaceuticati ItO. The undersigned is directed to refer to DGFT U.o.No. o1tg2l5ot1557lA[_ 16/DES-3/1663 dated the ',7Z16 ^vide *nicr,-Ipplication rro, utts Glenmark Pharmaceuticals Ltd. was sent to this Department roiiiation of norms ,n0., para:4.7 for the export of Fluticasone Lotion o.o5% (Pack aorr ,ro 60ml). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2OOg_14:_ Under Secretary to the oorurnr!Ti.|I',ffi? /J86 Export ltem lmport ltem Norms necomnrenOeO Fluticasone Lotion 0.05%(30ml O.OtSSgm/3Om1 pack 0.05% (60ml 2.

/

F. No.350 1 1 t2O1 t2016_pt (Norms) Government of lndia Deparlment of pharmaceuticals The undersigned is directed to refer to DGFT u g s 01/82rso/221/AM-17lDEs_ 3t302 dated the ts/t^o uio" iliJ rppri.riil;f.;ff5yor"p", r_rnr lto *r, sent to this Department for fixation oi noir. under pro, i.'l rorthe export J Atorvastat;,., carcium' This department has rxamineo the ,rtt"r.and the iorowing norms are furnished under para 4.7 or Hano e;ot oi iro."orrlrivor.rl 2oog_14:_ 1 145 2 UndersecretarytOtheGovernmξ l留‖出棚! PH:-23071162 DirectOrate Genera1 0f FOreign ttrade, Department Of commerce, 剛踏鼎:ミヽ ミ騰駐品 Office Memorandum subject: .li:t:i#,:'fl'#ilJl"JJ.17i;, of Hand Book of procedures (vor) 20os-14 Y78 Dated: August, 2016 tttorms@ 'lkg Export 0708k9 盤烏覇晰恵需要弥画面而 benzene b壁ムハ gバィ i百き 0.994kg 聖 Ch10ride

F. No.3501 1 l8t0t2}15-pt (Norms) Government of lndia Depa rtment of Pharmaceuticals Dated: 7 June. 2016 Office Memorandum

subject: - Fixation of norms under para 4.7 of Hand Book of procedures (Vol.l) 2oog-14

Case of M/s Sun pharma lndustries Ltd. The undersigned is directed to refer to DGFT u.o.No. o1lL2l5ot150g/AM- 16/DES-3/1625 dated the 16t2r16 vide,,yrrign rppri.rtrn rro, rr,,yl sun pharma lndustries Ltd' was s.ent to this Department for fixation of norms under para: 4.7 for the export of sertraline ! !:l and its tablets . This oepartment has examineJ rne matter and Ir"r5:iiling norms are furnished under prra +'.i ir'Hand Book or pio""oures (Vor.r) 2 Under secretary tO the Governm」i][μ濡品 ! PH:-23071162 七 Recommended fOr Activated carOon Palladium R) mandelic actd

F No 35011/141/2016-PI(Norms) Government ofindia ℃ :晶II謂[黒讐撃贈 1麻塁11闊ξ 蜀ゝ udyog::魁 in'ヽ::,現|: Ottice Memorandum suued― Fttlm塁 ::肥lせ11:1蟹11:[∬ Hand B00k OfPЮ CeduttS Ⅳdり2009■4 Case d MたSun 2009-14 2. This issues with the approval of competent authority' (Ralkumar) Under Secretary to the Government oflndia PH:-23071162 Directorate Genera1 0f Forelgn ttradel Department of COmmercebdyOg Bhawan,New Delhl (Shn M V Slngh,FTDO), of Procedures (Vol ule (all quantitY in mg) S No lmport item Lamivudine Nevirapine Zidovudine Efavireng Abacavir sulfate 1 Lamivudine 150m9 tablets/caPsules 1530 2 Nevirapine 200m9 tablets/caPsules 2040 3060 3 Zidovudine 300m9 *-hlatc/naner tloq 3060 4 Abacavir sulfate 300m9 fahlatc/r.:nsrtles 5 Efavirenz 200m9 tablets/caPsu les 2040 6 Efavirenz 600m9 tablets/capsules 6120 7 Lamivudine 150m9 + zidovudine 300m9 + abacavir sulfate 300m9 tablets/capsules 1530 3060 3060 8 Lamivudine 150m9 + zidovudine 300m9 tablets/capsu les 1530 3060 9 Lamivudine '150m9 + nevirapine 200m9 + zidovudine 300m9 tablets/capsu les 1530 2040 3060

F. No.350 11112112016-Pt (Norms) Sb Government of lndia 匂 Dated: July, 2016 Office Memorandum

subject: - Fixation-of norms under para 4.7 of Hand Book of Procedures (vol l) 2oog-14

Case of M/s IPCA Labs Ltd. The undersigned is directed to refer to DGFT U o.No. 01lg2l5ol108/AM-17/DES_ 31118 dated the 2315116 vide which application from ttltls lpCA Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of pyiantel pamoate. This department has examined the matter and the following norms are furnished under

para 4.7 of Hand Book of procedures (Vol.l) 2O0g_14:_

Under Secretary to the oor"rnrlTi'y,ffi? PH._ 23071162 Norms RecommenaEO tor 07653k CttHc acid S.No. lmport item １ 一 ２ Thiophene-2-aldehyde

Bon acid 3 4 u.JzuKg 5 ハじじLO「llI「Ile 0.2797k9

,slu" S/,nJ ,' 5l\ /9\T ⌒ 84 may necessary action as per above decision of NC. Export product ｐ Ｖ Ｅ ｘ Ｑ ｔ Si.No. lmport items Qty. allowed Ascorbyl Palmitate l Kg. Ascorbic Acid 0.500 ke 2. Palmnic Acid 0.127 ks RA concerned may take further

case No.:74l 46/82-ALc4/2oog PartyName:YASHo

Meet No/Date:7182- rNDUsrRrEs;;;:i;r. ALc4/zoto status:case 18.05.2010 Approved HQ File RLA Fite Lic.No/Date:0310550397 :0L/8210s0/oogso/AMlo/ :03/9s/0a0/oo578l AMTol LL.Lz.loOg Decision : committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.o. No.14010/4612009lch.il dated 17.05.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4,7 of HBp as per details , below or as applied by firm whichever is lower:-

´ 境 バ Government ofindia oe淵朧脚Ⅷ編よ∬畠電器,薗s Suqect: Advsnce Authorization application from M/S Balaji Amines PvL LE' for the import of rsw malerial against the exporl of N-Ethyl'2-Pynotidone' (Advance Authonzation No 3110065577 daled 04 08 2015) Ref u.o No. o1/82/050/01301/AM-16/DES'llll1352' dated 18'12 2015 Mrs- Balajr Amines Pvt. Ltd. has submitted present apPlication ior lhe import of raw mat€rial against the export ol N-Ethyl-2-Pyffolrdone' The application has been examined and ths Depannrent rscommends the following norms {or the This issues with the apProva! af clmpetent authority Tel No 011‐23381430 present Advance Aulhorization application. (A.K. AGAXWAL) Addl. lndustrial Adviser

（ （ 矛 鼈 晟 腑 ” 」 け ④ Government ol lndia Ministry of Chemicals and Fe.tilizers Oeparlment ol Chemicals and Petrochemicals SublecL Advan∝ Autho●za“ on applcaton from M′ s Balali Amines Pvt Ltd〔or the import Ol raw mate“ al aga nstthe export of N‐ Methyl・2・Pyrrondone (Advance AuthOr12atiOn No 3110065576 dated 04 08 2015) Rer U O No 01′ 82′050701 3027AM‐ 1670ES‐‖′1349 dated 18 12 2015 M7s Balali Amines Pvt Ltd has submlled present apphcation for the import of raw mate“ ョ I againstthe export of N・Methyt‐ 2-PyrrOIldOne The applicaton has been examined and the Departmentrecommends the folowin9 n。 「ms torthe present Advance Authori2atiOn application This issue v,/ith the approval of competent authority. (AK AGAMAL) Addl lndustrlal Adviser Tel No 011・23381430

Ｆ 竹 （ 置 唱 目 目 目 匿 目 Ｅ 日 蘭 聾 ｒ ” 鳩 ＝ Ｈ 青 Ｈ Ｅ ■ 軽 二 ， ■ 月 ＝ 情 Ｈ ｌ ｌ ＝ ほ Ｉ Ｉ 尋 Ｈ ■ Ｈ ■ ョ 〓 ■ １ １ ， Ｉ Ｉ 〓 １ １ ´ れ` ″ ° No.1410′ 122J2011_cH,‖ Govemment Ofindia Dep鼎翼麗棚禦S∬占電臨icJs

subject: Advance- Auihorization application from M/s. Balaji Amines pvt. Ltd. for the

impo.t of raw materiar against the export of Gamma Lutyroractone (Advance Authorization No. 3110065750 dated 5.11..2015) Ref: u-o. No. 0 1/82/050/01 s06/AM-1 6/DES-| r r/1 6sB dated 1 9.2.201 6 Itlus' Balaji Amines Pvt. Ltd. has submitted present apprication for the import of raw material against the export of Gamma Butyrolactone 'The apptr;ation has been examined ancl the Department recommends the followng norms forthe present Advance Authorizalion apptication. This issue with the approval of competent authority. 螺 ・ ` {A.K AGARWAL) Addl.lndustttal Adviser Tel.No.011-23381430 Dept d c&Pc February, 2016

粂 了F↑ F No 35011/171/2016-PI― Norrns Government oflndia Ministry of Chemical&Fertilizers New Delhi,the Office Memorandum Shasttt Bhawan, ぁ′′ 2′ 2016 Sutte∝ 一日Xtton d n∝ms undtt ptta 47ぶ 鼎 1謂 Ok d PЮ Cedttes Ⅳ “ り2009_44 Case of Mノs Fresenius Kabi Onc 丁he undersigned is directed tO refe 17/1DES-3/276 dated the 08/07/2016 vide l lmport ltem rorexp@ 1 gm/ 10 mt 2 grn/20 rni Cytarabine Ph Eur/USPノ|| 2 10 gm Glass Vials Relevant, As per packing policy Rubber Stoppers 2)This issues with the approva1 0f cOmpetent authOrity Under secretary to the oor"rnnl3;i [iffi? E m a i r :, J!_"#;, 3:U:,:r,i Deparlment of Commerce, Udyog Bhawan, New Delhi_110011 S.No 1 10gm 2 3

r ダζ/ F. No.3501 1/8212016-Pl (Norms) Government of lndia Ministry of Chemicals & Fertilizers Shastri Bhawan,New Delhi, Dated the December 20,2016 Office Memorandum

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

M/s Chiros Pharma, Solan in Himachal pradesh. The undersigned is directed to refer to DGFT u.o. No. 01/82/050/oo05g/AM-17/DES-Ill/74 dated the 1010512016 vide which application from M/s. chiros pharma., was sent to this Depa(ment for fixation of norms under para: 4.7 for the export of Amoxicillin & Clavulanate Potassium for Oral Suspension 312.5 mg (60 ml bottle each). This department has examined the matter and the norms against the above product are furnished as follows: - S No Product to be Exported ffi Raw materials to be lmported S No Description Quantity recommended fol1000 bottles , Amoxicillin & Ctavutanate ' Potassium for Oral Suspension I 312.5 mg in 60 ml boftles (each 5 ml of reconstituted I suspension contains: (i) Amoxicittin Trihydrate equivalent to 250 mg Amoxicillin &(ii) Potassium Clavulanate equivalent to 62.5 mg Clavulanic Acid. diluted with Microcrystalline Celluose in 1 :1 ratio) 1000 bottles Amoxicil‖ n Tnhydrate 3.482 kg 2 Potassium Clavulanate Diluted with Microcrystalline Celluose (1:1) 0.8276 kg Activity 3) This issues with the approval of competent authority. (Shri Nirmal Kumar, Dy DGFT), Email: nirma L kuma165@ n ic. in 民中しへひ´幕ぅ UnderSecrdav b he G盤計悧nf:「湘稽 Phone:23323292 Ema‖ :barn khast@nlc in

F. No.350 1 1 11012016-Pl (Norms) Government of lndia *6 Dated: 7 June, 2016 Office Memorandum

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

Case of M/s Unimax Laboratories Pvt. Ltd. The undersigned is directed to refer to DGFT U^O.No. 0118215011829/AM- 16/DES-3/19 dated ine Uq16 vide which application from M/s Unimax Laboratories Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Betametiri3ohe Dipropionate BP 93/USP 23lbetamethasone dipropionate. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14.- S.No. lmport item Norms Recommended for 1kq Export Betamethasone 0.86Bkq 2 (Rajkumar) PH..- 23071162

“ キ 両 ぼ 一 一 一 一 一 つ ´ ― F.NO.35011/66璽 1試LY° rrns) GOvernmc に出二 [黒辮腫臨:識T郎 DateyttgBhttl‖ 滋朗|: SutteCt:― [itl:1111[lil]:ntll:li fProcedure,(vOl・1)20o9_14 case Of Office Mernorandum The undersigned is di 糖轟籠7憐III五冒:咄 t晰 Ⅷ・ 1漱謂雀慰η ttYJ5わ薦引馴 鷲Fツk贈ⅢⅢこ I嵐 1:Lttl:1li& 婆郡窃attj脱麒 、 讐轡こ 1撃翼― r潔 聾輝i榔隠瑚灘鷺畿欄簾響::物饉

para 4.7 0fHand b。。

k。1百:::麒:I耽1;男秘 :|″ d theおHOW・i亀玉 :蹴ξ :」L‖ぶ醜艦鬼 } DirectOrate General ofFOreign Trade, Department Ofcommerce, 織肌謝Ⅷ批i 晩 “ r%∝daッゎ山e GO縄観 粋 響 Import Item Qty. R."orr.nO.a_ iclopirox USp 235.6m邸o鰤pack 353.omg/45gm pack 785.olng/100gm pack

01′32F050/OC89o〃tM17/ 11,03.2016 : The Gommittee en by NC in its meeting applied by the fimr rvhic to raiily notrrls ort rei)sei basis tr.- f穐蛾‖ d響'::鰐れT潔詢番リ the earlier decisi end of thr:se minutea F.A concerrled rnay tak lNE c ‖口l丁ED、 NorDate112′ `2 50縣D0127ノAM17ノ iC'lolDatei0310ooo767 122015 on : The Cornmitteo decided to by NC in ls meeting No,04錫2 appti€d by the firm whiehever is acticn as pcr Ceciaion talt s:Api:rovetl C412016 .00.2016 メT:鍔:::意期警爾t譜湯複」 111認 undel para 4.07 of HEP Vr)|,1_ RA conoerned rray IS 衝 1219 rvhichcver is lcss: Export producrt 百x, 0" SLNo. lmport items av aliowed Para vettiaり8uty: Cycbhe湾ソAcette l Xg 1 Para fediary Eutyl phenot 0.320 kg 2. 5% Ruthenlurn on Cartoil Qatalyst 0.00003k9 3 Aoolic Acid 0300短 4 Methanc: 0.330k9 m畔法c appmpHa韓慮 i。議百s pcrぬc dccヽおnOfNonns Cunmhたこ ハ 'trii xo.iresnl,ltt- - - ilmry x*,ojrr.tbimnrr. rrccr lloina E:4t82. Sterus:Crre ALC4r!0r2 itti:y,oii * rrnnrs Ar,i;;;ii'' "'"'- arril," rari,- - iil'H: ,i:e*j,:::03,0?2as{o i;-;;, l:0r/E2i0s0oBt0/AM[/_ [0]/r{,04o,t09??JAMB/ ;r;.OZ.ZOB I i Dirt", , I" rh-lighr;ir nir,"n co.drs *r.,*o ;;r,;;;;ttt oI qren,i";,, ,, I iretrochemical.s vide thetu u.o No. l40l0i90n0l l -ch" II oatei l0.s,t0l 3. it ** ariafi i

ハ lf ″ 「 ‐~ Dccision:ln the‖ ght Of written comments received from Department Of chemicals and Petrochemicals vide their∪.O No 14010/20/2012-Ch ll dated 22.11.2013′ it was decided to ratify norms under Para 4.7 0f HBP vl as per detalls given be10w Or as applied by the nrm′ whicheveris less: RA may take appropriate action as per the decision of Norms commrttee. lmport items ASTROMusK(S) (Asti・Omusk cOntenti 100%) S‐ PROPYLENE OXIDE AIンPHA METHYIンSTYRENE PARAFORMALDEHYDE Casc No.:20/19/82- 1)arty Nanlc:(〕 AMPHOR& Mcct No/Datei1 9/82- stattisiCase ALC4/2013 A LLレIED PRODUC´「S AlンC4/2013 Approve(1 1ンIN/11‐ 1｀1]I)、 o2012014 :HQ Filc ‐RLA Filc l″ ic,No/Datc:0310751566 1Defcr Datc: :Πマ「‖じ 11くLA l・‖C l″ ic,No/Dat l:01/82/()50/00965/AM14/ 1:03/94/040/00560/AM14/ 27.09.2013

F.No.35011/104/2015¨ PI NOrms) ゞこつ Goverlment oflndia Ministry of Chclllicals&FeFtiliZeFS ~~ ~ Departlllent ofPhallllaceuticals Udyog Bhawan,Nc、Dclhi、 Dated the septёmber,2015 0fflce Ⅳ〔cmOrandum Stlttecti_FixatiOn ofnOrms under para 4,7 ofHand B00k OfProcedurcs(v01.1)2009_14 Casc Of レ1/s2へlenlbic Pharina Ltd. The undersigned is directed tO rcfcr tO DGFT U.〇.No.01/82/50/1133/AM_15/DES― 3ピ■:鰍:I:嘉:晨li:fl珈鯖 せ認 °n.。mw&NcmЫ c Phama Ld略 “ 正Ю para: 4.7 for thc cxpolt Of valsartan and 柵:離:Ⅷ譜冨llゃ蘊 tl得淵慧1吉:那::鋼茸や J°Ⅲ号 g号?rT T [B]Norms for lkg Valsartan DirectOrate Genera1 0fForeign Trade, Depalmcnt of COIFllllerce, (Shi M.V.Singh,FTDO), UdyOg Bhawan,New Dclhi UndersccretarytOthcGolil‖ :榔:驚|! Phone:23071162 Norms re"o,-,.,,l,i, cl"d +12.5 nl Valsartan---8 I . 6;,q/Tub ler. 160111g+12.5 r― dO―- 163.2 mg/Tablets 160 rng *25 m ―dO―- 163.21nノTablcts 320111g+12.5 nl ―dO―- 326.41■ゴTablets 320 m.q +25 m … 6 4 1nJTablets Import Item Q″ .Rec01■mended kゴkg. 億り0シーК2C ―mctllyi bLltanOate eJlancdioatc(Biphcnylvalinc Oxalate) 1.455kg/kg 0.6371it/kg ethylene Chloride 1o. nicnto-r"tlra,re)

幼 Government of lndia Ministry of Chemicals and Fertilizers Department of Chemicaf"?y Petrochemicats

Subject: Advance Authorization application from M/s. Galaxy Sur.factants pvt. Ltd. for the

import of raw material against the export of octyl Diphenyl cyanoacrylate Advance Authorization No 0310793796 dated ll.2.2015 Ret DGFT U.O.No.01/83/50/426/AM‐ 16/DES‐ 3/464,dated o7.7.2015 M/s. Galaxy Sulfactants Pvt. Ltd. have subnlitted present app‖ cation for the impOrt of raw material againstthe expOrt Of octyl Diphenyl Cyanoacrylate The application have been examlned and the Department recOmmends the fO‖ Owing norrns forthe present Advance Authorization application. Item of Export Qty´ 撻m_二艶pOI 颯 ― ― … 0.35oO kg, Octyl Diphenyl Cyanoacrylate l kg, 1.METHYL CYANOACETATE 2.2ヽETHYL HEXYL ALCOHoL 0.4260 kg 3.BヒN∠OPHENONE 4.HDPE GRANULES 0.5250 kg As per packing policy 認話 r Tel.No.011-23381430 汚 |ろ|∩“ ‐ ・ :ら Qャふιも 一 ⌒ Fa奮声 、 １ ■ ノ … ||「 ゛ い 囃 ' Deptt, of C&Pc No,14010/148/2011 ‐CH―|l dated?o.92015 ． 一 一 一 ． 一 一 一 一 一 ・ 一 一 一 一

F. No. 350'l 1 1237 120 16-Pt (Norms) Government of lndia 坊 `7q ∪dyo9 Bhawan,New Dё lhi, Dated: octOber,2016 0ffice Memorandum SutteCt― F峡a百on ofnorms under para 4.7:[:租 :.B° °k of Procedures(∨○|り2009_14 -Case of M/s Supriya Life Scien The undersigned is directed to refertl 3/434 dated the 19/8/2016 vide which appl vvas sent to this Department fOr fixatiOn o Ractopanline Hci.This depa■ment has ex are furnished under para 4 7 of Hand B00k 2 Under secretary tO the Governm[i::#謂品! PHi-23071162 Udyog Bhawan, New Delhi. Octopamine Hcl Raspberry Ketone Palladium on Charcoal S%

1兵 Government of lndia Ministry of Chemicals and Fertilizers Department of Chemicals and Petrochemicals りヶ‐ SubieCt:Advance Authottzation application from M/s.clean Science and ttechnology Pvt.Ltd. for the import of raw matettal against the export Of MoNO METHYL ETHER OF HYDROQUINONE一MEHQ 99%PURITY. (Advance authorization No.311006571l dated 21.10.2015) Ref: U.〇.No.01ノ82/050/01418/AM16/DES― lll/1571 dated 15.01.2016 ヽ1/s. Clean Science and Technology Pvt. Ltd. have subnlitted present app‖ cations fOr the import of raw mateHal againstthe expuil↓f MONtt MEttHYL ETHER OF HYDROQulNONE 一MEHQ 99%PURITY. The application have been exanlined based On the additiOn infOrrnation furnish by the 輌rm.丁he Department recommends the following norms fOr the present Advance AuthottzattOn app‖ cation. Item of Export Qtv. Item of lmport Qty l.310 kg MONO MEttHYL ETHER OF HYDROQUINONE一MEHQ (PURITY 99%MINIMUM) l kg PHENOXY METHANE/ANISOLE~ 翌り卿丁Y93%MAXIMuM) 0.825 i<g 3 ACETONE 0.270 kg This issue with the approval of competent authority. 馘

唯 Tel.No.011-23381430 Deptt Of C&PC U.〇.No.14010/3/2012-CH― ||(VOI.― |)dated 16.02.2016 ヽ＼

ゞa¶ F. No.350 I 1 130412015-PI Qr{orn-rs) Goverrunent of india Ministly of Chemical & Fer-tilizers Depaftment of Pharmaceuticals Udl o_u Bha,uvan. Ner,v Dellii. the Ocrober. 201_5 Office Memorandum

Subject: - Fixation of norms under para4.7 of Hand Book of Procedures (vol.l) 2009-14 case

of M/s Alembic Pharma Ltd. Tlre undersigned is directed to refer to DGFT u.o.No. 01/g2l50llog/,\M-16/DES-3/103 VI ULJ-JI IlJ) *1t:1_15 l,6l:611: vide rvhich application fi'om M/s. Alembic pharma Ltd ,"vas se,r to this ~ ^^^― ヽ八エムい ― L、= VVιo Oヽ1lt tu LIllb Departnlcnt for flxation Of norins undcr para: 4.7 fOr thc expo■ Of Fortifled PrOcaine Dハ綺:ハ111:“ ′ ヽだ^～^ ■1_■■_ Tl・ 1 . Penicillin 4 ⅣIega lnjectiOn.Tllis departmcnt has cxamined thc mattcr and thc bl10wing llorms Яre flirnlミherl linパ。 1・ハOro/47ハf口^^月D^^1_^rヽ _ 1 /、ァ ..、 ―^ norms are ftlrnished llnder para 4.7 of Hand B↑ Tk ofProcedures(vOl.1)2009_14:― DirectOrate Genera1 0fForeign Trade, Depailllent of COnlnerce. (Sl■・iM.V.singh,FTDO), UdyOg Bhawan,New Dell■ i under Secretary to the ""9.ffi:'rfffii,11'] Phone:23071 162 ハ Nonns for 1 Lakh vials. BenzyI Penicillin Sterilざ IP/BP 298.2456 BOu I Pellicillill sOdiuln Stcrile IP/BP 96.4912 Bou

'lo F.No.350H/423/2015¨ PI(Norms) _ Goverlmcnt oflndia _ _ _ Ⅳfinistry of Chcmical&Fe■ilizers Depaltnlent of Pharinaceuticals Udyog Bhawa11, Ncw Delhi,thc octobcr,2015 0伍cc Memorandum SutteCt:― Fixation of■orms under para 4.7 of Hand B00k of Proccdures(vOl.1)2009_14 Case of M/s Mylan Labs Ltd. The undersigned is directed to retrto DGFT U.〇.NO.o1/82/50/511/AM-16/DES-3/546 ■ted tle o9/07ィ15 vide wいiCh applicadon■Om M/s:Myl叩Labs Ltd was scnt t6 thぉ 椰丼質椰器鶴難棚露 i酬認糀柵:窮嚇 Imporl ltem Qty. Recommendecl kg/kg. -)-Trans-4R-(-4-Fluorophenyl)-3 S-Hydro*yrrrett yt_ -)Methyl Piperidine (Trans HMp) hane SulfOnvl ch10ride riethylamine 'otassium Carbonate Isopropyl Alcohol under sccretary to the G:lli11:II:fiI:: Phonc:23071162 E)irectOrate Genera1 0f Foreign Trade, Depaltment of COmnlerce, (Sl■・iMV.Singh,FTDO), UdyOg Bhawan,New Delhi

′∫ 一g″ | File~No「35011/606/2015二P卜Norms Governmen1 0flndia 糖累』 [黒辮電鷺蹴1髭IS 0「 筋暮警綱蔓紳郷L堤奎儡場剃蠍誓蝋 9ppliCant fO「this expott product 3)丁his issues with the apprOva1 0f cOmpetent authOttty. Under Secretary 10 1he G鞘 鴛11:1111 Direc10rate General of FOreign Trade, Depariment Of commerce, (Shri Ratan Lal Meena,FTDo), Udyog Bhawan,New Delhi OFFICE MEMoRANDuM 鈍 :眈 ~縫 欄熙鱗蜻[:t聯:寄i潤1ビ蝸臨吼 畢硼‖ r彙糖1鳶嬬輔ゞ二∬吉革£ξ鶴鼈ξ y町2∝.The ttLIま the same export prOJicil 精s:譜器:亀厘 「 19膚喜t胤凡::1出i譜褥£ :ξ期11稽舞戦£ :I Shastri Bhawan, New Delhi Dated: August 29,2Oj6 ~“… 1,日 |||||||||||||||||||||||||11ロロロ 1日目目 :||||||||||||||||||||||||||||||||||ロロ |||||口|■■■■ ヽ い ヽ Em計占も出[bhム高a@iば詰

「 ． 一 一 Government of lndia Minisiry of Chemicals and Fertilizers Department of Chemicals and petrochemicals Advance Authorization application f「om Mノs. Yasho lndustries Pvt. Ltd. for the import of raw materials against the export Of Yantq 2030B(25%Solution of 丁ertia「y Butyl Hydroquinone) (Advance Authorization No. 0310792428 dated 29.12.2014) (Advance Authottzalon No.0310794375 dated 4.3.2015) Ref: U.O.No 01/82/050/260,480/AA』 16/1DES― |‖/188,361 dated 29.6.2015 and 3.7.2015 I\I/.q Yasho lndustries (P) Ltd. has submitted preseni apptications for the import of raw materials against the export of Ycntn ?n?nn Q5% Sclution of Teriiary Butyl Hydroquincne) The application has been examined and the Department recommends the following norms for the present Advance Authorization application. Yantq 20308 (25% Soluiion of Tertiary Buiyi Hydr oquinone) l kg.

1. Hydroquinone 0.352 Kg Tertiary Butanol 0260 Kg Addl.lndustrial Advise「 Tel.No.011-23381430 Deptt.of C&PC U.O.No.14010/95/2011-CH― |l dated ヽl.9.2015 Qty
2. liem of Expori liem of lmpori
3. Propylene Glycol (A_K AGAR由ノAL) Subject: Qty. 0.650 Kg