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. 04/82/2016 of 2016-17, to consider the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products and falling under Chapter 29 and 30, held on 24.05.2016 under the Chairmanship of Dr. S.K. Bansal, Jt. DGFT in Room No.04, Udyog Bhawan, New Delhi. Following members were present:- Shri Nirmal Kumar, Dy. Director General of Foreign Trade Shri D.N.Mathur, Consultant, D/o Pharmaceuticals. Shri M.V. Singh, FTDO, DGFT The committee went through the minutes of earlier meeting No. 03/82 held 12.05.2016 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 : 4/82-ALC4/2016 MEETING DATE : 24.05.2016 1

Case No.:132/8/82-

ALC4/2014 Party Name:PROVENTUS LIFE SCIENCES PRIVATE LIMITED, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00796/AM15/ RLA File :04/24/040/00395/AM08/ Lic.No/Date:0410094357 12.03.2008 Defer Date:14.06.2016 Decision : The Committee noted that information had been called for from the firm in NC meeting No.05 dated 25.6.2015 is awaited. The Committee accordingly decided to await the reply and deferred the case. 2

Case No.:70/4/82-

ALC4/2016 Party Name:RAKSHIT DRUGS PVT LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00133/AM17/ RLA File :09/71/040/00061/AM12/ Lic.No/Date:0910048210 11.08.2011 Defer Date:14.06.2016 Decision :Deferred for want of comments from DoP. 3 Case No.:15/2/82- ALC4/2016 Party Name:PERFECT INDUSTRIES PRIVATE Meet No/Date:4/82- ALC4/2016 Status:Case Deferred

2 LIMITED. 24.05.2016 HQ File :01/82/050/00015/AM17/ RLA File :03/95/040/00554/AM12/ Lic.No/Date:0310659678 14.10.2011 Defer Date:14.06.2016 Decision :Deferred. 4

Case No.:36/19/82-

ALC4/2014 Party Name:ALKALI METALS LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01524/AM15/ RLA File :09/24/040/00503/AM12/ Lic.No/Date:0910052125 12.04.2012 Defer Date:14.06.2016 Decision : Deferred. 5

Case No.:38/19/82-

ALC4/2014 Party Name:PORUS LABORATORIES PVT LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01526/AM15/ RLA File :09/24/040/00050/AM13/ Lic.No/Date:0910052706 21.05.2012 Defer Date:14.06.2016 6

Case No.:18/19/82-

ALC4/2014 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01506/AM15/ RLA File :09/24/040/00085/AM13/ Lic.No/Date:0910052887 05.06.2012 Defer Date:14.06.2016 Decision : The Committee noted that information furnished by the firm is incomplete. The Committee decided to call for Central Excise Certificate for production consumption of export product and deferred the case. 7

Case No.:173/5/82-

ALC4/2015 Party Name:FORACE POLYMERS (P) LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00313/AM16/ RLA File :05/23/040/00069/AM14/ Lic.No/Date:0510356983 13.06.2013 Defer Date:14.06.2016 8

Case No.:61/4/82-

ALC4/2016 Party Name:ADCOCK INGRAM LTD, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00124/AM17/ RLA File :07/24/040/00097/AM14/ Lic.No/Date:0710096460 04.07.2013 Defer Date:14.06.2016 Decision : The Committee decided to defer the case for want of comments from DoP. 9

Case No.:31/4/82-

ALC4/2014 Party Name:UNIVERSAL BIOFUELS PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00279/AM15/ RLA File :09/24/040/00155/AM14/ Lic.No/Date:0910056959 31.07.2013 Defer Date:14.06.2016 No.19 dated 25.2.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 10 Case No.:41/16/82- ALC4/2013 Party Name:KARNATAKA ANTIBIOTICS & Meet No/Date:4/82- ALC4/2016 Status:Case Deferred

3 PHARMACEUTICALS LTD., 24.05.2016 HQ File :01/82/050/00854/AM14/ RLA File :07/24/040/00188/AM14/ Lic.No/Date:0710098283 16.09.2013 Defer Date:14.06.2016 11

Case No.:140/23/82-

ALC4/2013 Party Name:UNITED PHOSPHORUS LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01187/AM14/ RLA File :03/95/040/00495/AM14/ Lic.No/Date:0310758627 21.11.2013 Defer Date:14.06.2016 Decision : Deferred. 12

Case No.:48/13/82-

ALC4/2015 Party Name:BELCHEM INDS. INDIA PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01011/AM16/ RLA File :03/94/040/00860/AM14/ Lic.No/Date:0310766718 17.01.2014 Defer Date:14.06.2016 Decision :Deferred. 13

Case No.:208/3/82-

ALC4/2014 Party Name:OGENE SYSTEMS INDIA PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00212/AM15/ RLA File :09/24/040/00515/AM14/ Lic.No/Date:0910059017 22.01.2014 Defer Date:14.06.2016 Decision : The Committee noted that information called for from the firm in NC meeting No.13/AM16 dt. 27.11.2015 is awaited. The Committee accordingly decided await the reply and deferred the case. 14

Case No.:108/3/82-

ALC4/2014 Party Name:CROPNOSYS (INDIA) PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00112/AM15/ RLA File :03/94/040/00908/AM14/ Lic.No/Date:0310767733 24.01.2014 Defer Date:14.06.2016 No.17/AM16 dt. 27.01.2016 is awaited. The Committee accordingly decided await the reply and deferred the case 15

Case No.:177/3/82-

ALC4/2014 Party Name:INDO AMINES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00181/AM15/ RLA File :03/94/040/00958/AM14/ Lic.No/Date:0310768616 30.01.2014 Defer Date:14.06.2016 No.13/AM16 dt. 27.11.2015 and NC meeting No.16/AM16 is awaited. The Committee accordingly decided await the reply and deferred the case. 16

Case No.:58/6/82-

ALC4/2014 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00460/AM15/ RLA File :03/94/040/00797/AM14/ Lic.No/Date:0310772503 28.02.2014 Defer Date:14.06.2016

4 deferred the case. 17

Case No.:106/3/82-

ALC4/2014 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00110/AM15/ RLA File :03/95/040/00960/AM14/ Lic.No/Date:0310772411 28.02.2014 Defer Date:14.06.2016 deferred the case. 18

Case No.:58/4/82-

ALC4/2014 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00306/AM15/ RLA File :22/24/040/00100/AM14/ Lic.No/Date:2210014694 14.03.2014 Defer Date:14.06.2016 Decision :The Committee noted information has been called for as per Appendix 33 by NC in its meeting No.03/82 dated 20.05.2015 and it is awaited. The Committee accordingly deferred the case. 19

Case No.:57/3/82-

ALC4/2014 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00061/AM15/ RLA File :05/23/040/00506/AM14/ Lic.No/Date:0510382053 18.03.2014 Defer Date:14.06.2016 deferred the case 20

Case No.:51/5/82-

ALC4/2014 Party Name:JINDAL DRUGS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00368/AM15/ RLA File :03/94/040/01098/AM14/ Lic.No/Date:0310776087 27.03.2014 Defer Date:14.06.2016 No.13/AM16 dt. 27.11.2015 is awaited. The Committee accordingly decided await the reply and deferred the case. 21

Case No.:51/6/82-

ALC4/2014 Party Name:PERFECT INDUSTRIES PRIVATE LIMITED. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00453/AM15/ RLA File :03/95/040/01054/AM14/ Lic.No/Date:0310776759 02.04.2014 Defer Date:14.06.2016 deferred the case. 22

Case No.:50/6/82-

ALC4/2014 Party Name:V & V PHARMA INDUSTRIES Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00452/AM15/ RLA File :03/95/040/01061/AM14/ Lic.No/Date:0310776760 02.04.2014 Defer Date:14.06.2016

5 deferred the case. 23

Case No.:20/6/82-

ALC4/2014 Party Name:ADISHANK CHEMICALS PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00422/AM15/ RLA File :03/94/040/01140/AM14/ Lic.No/Date:0310777786 09.04.2014 Defer Date:14.06.2016 deferred the case. 24

Case No.:91/4/82-

ALC4/2016 Party Name:LAKE CHEMICALS PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00154/AM17/ RLA File :07/24/040/00441/AM14/ Lic.No/Date:0710103512 09.04.2014 Defer Date:14.06.2016 Decision : The Committee deferred the case for want of comment from DoP. 25

Case No.:49/13/82-

ALC4/2015 Party Name:BELCHEM INDS. INDIA PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01012/AM16/ RLA File :03/94/040/01118/AM14/ Lic.No/Date:0310779215 23.04.2014 Defer Date:14.06.2016 Decision :Deferred. 26

Case No.:183/6/82-

ALC4/2014 Party Name:TIDE INDUSTRIES Meet No/Date:4/82- ALC4/2016 24.05.2016 Status: Case Approved HQ File :01/82/050/00585/AM15/ RLA File :34/24/040/00005/AM15/ Lic.No/Date:3410039854 23.04.2014 Defer Date: Decision :This case has already approved in NC 21/82 dated 23.3. 2016 at Sl.No.26 27

Case No.:237/6/82-

ALC4/2014 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00639/AM15/ RLA File :17/24/040/00002/AM15/ Lic.No/Date:1710005803 05.05.2014 Defer Date:14.06.2016 Decision :Deferred. 28

Case No.:13/2/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00028/AM16/ RLA File :05/23/040/00080/AM15/ Lic.No/Date:0510387607 28.05.2014 Defer Date:14.06.2016 deferred the case. 29

Case No.:38/8/82-

ALC4/2014 Party Name:MYLAN Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred

6 HQ File :01/82/050/00702/AM15/ RLA File :09/24/040/00108/AM15/ Lic.No/Date:0910060258 28.05.2014 Defer Date:14.06.2016 Decision : The committee decided to send copy of application again to DoP. 30

Case No.:165/6/82-

ALC4/2014 Party Name:HALDIA PETROCHEMICALS LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00567/AM15/ RLA File :02/24/040/00037/AM15/ Lic.No/Date:0210203844 05.06.2014 Defer Date:14.06.2016 Decision :Deferred. 31

Case No.:106/8/82-

ALC4/2014 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00770/AM15/ RLA File :03/94/040/00131/AM15/ Lic.No/Date:0310785223 12.06.2014 Defer Date:14.06.2016 Decision :Deferred. 32

Case No.:60/10/82-

ALC4/2014 Party Name:BIO-TECH OPHTHALMICS PVT. LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00974/AM15/ RLA File :08/24/040/00116/AM15/ Lic.No/Date:0810132332 13.06.2014 Defer Date:14.06.2016 No.11/AM16 dt. 28.10.2015 is awaited. The Committee accordingly decided await the reply and deferred the case. 33

Case No.:77/8/82-

ALC4/2014 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00741/AM15/ RLA File :03/94/040/00196/AM15/ Lic.No/Date:0310785501 17.06.2014 Defer Date:14.06.2016 No.19/AM16 dt. 25.02.2015 is awaited. The Committee accordingly decided await the reply and deferred the case. 34

Case No.:20/8/82-

ALC4/2014 Party Name:SRINI PHARMACEUTICALS LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00684/AM15/ RLA File :09/24/040/00139/AM15/ Lic.No/Date:0910060467 17.06.2014 Defer Date:14.06.2016 35

Case No.:202/6/82-

ALC4/2014 Party Name:FORACE POLYMERS (P) LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00604/AM15/ RLA File :05/23/040/00139/AM15/ Lic.No/Date:0510389232 01.07.2014 Defer Date:14.06.2016 Decision :Deferred. 36

Case No.:72/10/82-

ALC4/2014 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred

7 HQ File :01/82/050/00986/AM15/ RLA File :07/24/040/00112/AM15/ Lic.No/Date:0710105884 18.07.2014 Defer Date:14.06.2016 Decision :Deferred. 37

Case No.:203/5/82-

ALC4/2015 Party Name:ALKALOIDS CORPORATION Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00343/AM16/ RLA File :02/24/040/00080/AM15/ Lic.No/Date:0210204732 07.08.2014 Defer Date:14.06.2016 Decision :Deferred. 38

Case No.:21/9/82-

ALC4/2014 Party Name:PI INDUSTRIES LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00818/AM15/ RLA File :13/24/040/00020/AM15/ Lic.No/Date:1310047575 12.08.2014 Defer Date:14.06.2016 Decision :Deferred, 39

Case No.:264/13/82-

ALC4/2014 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01267/AM15/ RLA File :03/94/040/00405/AM15/ Lic.No/Date:0310788397 26.08.2014 Defer Date:14.06.2016 Decision :Deferred. 40

Case No.:254/13/82-

ALC4/2014 Party Name:SEQUENT SCIENTIFIC LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01257/AM15/ RLA File :03/95/040/00459/AM15/ Lic.No/Date:0310788513 28.08.2014 Defer Date:14.06.2016 Decision :Deferred for want of comments of DoP. 41

Case No.:263/13/82-

ALC4/2014 Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01266/AM15/ RLA File :03/94/040/00962/AM14/ Lic.No/Date:0310788558 01.09.2014 Defer Date:14.06.2016 Decision :Deferred. 42

Case No.:217/13/82-

ALC4/2014 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01220/AM15/ RLA File :03/94/040/00494/AM15/ Lic.No/Date:0310788620 02.09.2014 Defer Date:14.06.2016 43

Case No.:6/8/82-ALC4/2014 Party Name:HONOUR LAB

LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00670/AM15/ RLA File :09/24/040/00314/AM15/ Lic.No/Date:0910060964 12.09.2014 Defer Date:14.06.2016

8 44

Case No.:380/5/82-

ALC4/2015 Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00520/AM16/ RLA File :22/24/040/00054/AM15/ Lic.No/Date:2210015086 16.09.2014 Defer Date:14.06.2016 Decision : Deferred for want of comments from DoP. 45

Case No.:188/13/82-

ALC4/2014 Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01191/AM15/ RLA File :03/94/040/00102/AM15/ Lic.No/Date:0310789322 17.09.2014 Defer Date:14.06.2016 Decision :Deferred. 46

Case No.:57/13/82-

ALC4/2014 Party Name:HELLO PAINTS (P) LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01060/AM15/ RLA File :05/23/040/00277/AM15/ Lic.No/Date:0510391246 19.09.2014 Defer Date:14.06.2016 No.19 dated 25.2.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 47

Case No.:59/13/82-

ALC4/2014 Party Name:HELLO PAINTS (P) LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01062/AM15/ RLA File :05/23/040/00276/AM15/ Lic.No/Date:0510391245 19.09.2014 Defer Date:14.06.2016 Decision : The Committee noted that information called for from the firm in NC meeting No.19 dated 25.2.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 48

Case No.:9/15/82-

ALC4/2014 Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01296/AM15/ RLA File :09/24/040/00327/AM15/ Lic.No/Date:0910061001 19.09.2014 Defer Date:14.06.2016 Decision : Department of Pharmaceuticals have furnished their recommendation vide O.M. no. 35011/671/2015-PI (norms) dated 03.05.2016 has also pointed out to ensure the availability of valid drug manufacturing licence (DML) for commercial production. Keeping this in view, the committee decided to call for copy of valid Drug Manufacturing license from the firm. 49

Case No.:17/13/82-

ALC4/2014 Party Name:GRASIM INDUSTRIES LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01020/AM15/ RLA File :34/24/040/00155/AM15/ Lic.No/Date:3410040570 23.09.2014 Defer Date:14.06.2016 Decision :Deferred. 50

Case No.:115/13/82-

ALC4/2014 Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred

9 HQ File :01/82/050/01118/AM15/ RLA File :02/24/040/00097/AM15/ Lic.No/Date:0210205008 23.09.2014 Defer Date:14.06.2016 51

Case No.:89/4/82-

ALC4/2016 Party Name:BRUNDAVAN LABORATORIES PRIVATE LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00152/AM17/ RLA File :09/24/040/00304/AM15/ Lic.No/Date:0910061022 24.09.2014 Defer Date:14.06.2016 52

Case No.:74/13/82-

ALC4/2014 Party Name:CONSTECH ENTERPRISES PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01077/AM15/ RLA File :05/23/040/00282/AM15/ Lic.No/Date:0510391308 24.09.2014 Defer Date:14.06.2016 Decision :Deferred. 53

Case No.:9/2/82-ALC4/2015 Party Name:JUBILANT

GENERICS LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00024/AM16/ RLA File :05/23/040/00261/AM15/ Lic.No/Date:0510391358 26.09.2014 Defer Date:14.06.2016 Decision :Deferred. 54

Case No.:19/13/82-

ALC4/2014 Party Name:SANO MEDICAL KITS PVT. LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01022/AM15/ RLA File :04/24/040/00171/AM15/ Lic.No/Date:0410159504 29.09.2014 Defer Date:14.06.2016 Decision :Deferred. 55

Case No.:160/13/82-

ALC4/2014 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01163/AM15/ RLA File :03/94/040/00544/AM15/ Lic.No/Date:0310789976 07.10.2014 Defer Date:14.06.2016 Decision :Deferred. 56

Case No.:5/9/82-ALC4/2014 Party Name:HETERO

DRUGS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/00802/AM15/ RLA File :09/24/040/00362/AM15/ Lic.No/Date:0910061060 07.10.2014 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/631/2015-PI(Norms) dated 12.05.2016, 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. 57

Case No.:35/13/82-

ALC4/2014 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred

10 HQ File :01/82/050/01038/AM15/ RLA File :05/23/040/00218/AM15/ Lic.No/Date:0510391491 08.10.2014 Defer Date:14.06.2016 Decision :Deferred. 58

Case No.:76/13/82-

ALC4/2014 Party Name:CAPLIN POINT LABORATORIES LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01079/AM15/ RLA File :04/24/040/00163/AM15/ Lic.No/Date:0410159566 13.10.2014 Defer Date:14.06.2016 59

Case No.:42/15/82-

ALC4/2014 Party Name:PVS AGRO VET Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01329/AM15/ RLA File :09/24/040/00246/AM15/ Lic.No/Date:0910061105 16.10.2014 Defer Date:14.06.2016 Decision :Deferred. 60

Case No.:154/13/82-

ALC4/2014 Party Name:GEM AROMATICS PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01157/AM15/ RLA File :03/94/040/00680/AM15/ Lic.No/Date:0310790351 17.10.2014 Defer Date:14.06.2016 Decision :Deferred. 61

Case No.:12/20/82-

ALC4/2015 Party Name:STERICON PHARMA PVT.LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01595/AM16/ RLA File :07/24/040/00255/AM15/ Lic.No/Date:0710106853 17.10.2014 Defer Date:14.06.2016 62

Case No.:110/13/82-

ALC4/2014 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01113/AM15/ RLA File :34/24/040/00188/AM15/ Lic.No/Date:3410040635 22.10.2014 Defer Date:14.06.2016 Decision :Deferred. 63

Case No.:86/10/82-

ALC4/2014 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01000/AM15/ RLA File :34/24/040/00194/AM15/ Lic.No/Date:3410040644 30.10.2014 Defer Date:14.06.2016 Decision :Deferred. 64

Case No.:266/13/82-

ALC4/2014 Party Name:ATUL LIMITED, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01269/AM15/ RLA File :08/24/040/00289/AM15/ Lic.No/Date:0810133735 05.11.2014 Defer Date:14.06.2016 Decision :Deferred.

11 65

Case No.:268/13/82-

ALC4/2014 Party Name:ATUL LIMITED, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01271/AM15/ RLA File :08/24/040/00283/AM15/ Lic.No/Date:0810133734 05.11.2014 Defer Date:14.06.2016 Decision :Deferred. 66

Case No.:107/13/82-

ALC4/2014 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01110/AM15/ RLA File :34/24/040/00196/AM15/ Lic.No/Date:3410040655 05.11.2014 Defer Date:14.06.2016 Decision :Deferred. 67

Case No.:114/13/82-

ALC4/2014 Party Name:VIRDEV INTERMEDIATES PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01117/AM15/ RLA File :52/24/040/00042/AM15/ Lic.No/Date:5210041292 10.11.2014 Defer Date:14.06.2016 Decision :Deferred. 68

Case No.:111/13/82-

ALC4/2014 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01114/AM15/ RLA File :05/23/040/00352/AM15/ Lic.No/Date:0510391927 11.11.2014 Defer Date:14.06.2016 Decision :Deferred for want of comments from AYUSH. 69

Case No.:393/5/82-

ALC4/2015 Party Name:MYLAN Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00533/AM16/ RLA File :09/24/040/00387/AM15/ Lic.No/Date:0910061210 11.11.2014 Defer Date:14.06.2016 70

Case No.:61/18/82-

ALC4/2014 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01427/AM15/ RLA File :34/24/040/00198/AM15/ Lic.No/Date:3410040676 11.11.2014 Defer Date:14.06.2016 Decision :Deferred. 71

Case No.:100/4/82-

ALC4/2015 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00139/AM16/ RLA File :17/24/040/00125/AM15/ Lic.No/Date:1710005978 12.11.2014 Defer Date:14.06.2016 Decision :Deferred. 72 Case No.:120/13/82- ALC4/2014 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:4/82- ALC4/2016 Status:Case Deferred

12 24.05.2016 HQ File :01/82/050/01123/AM15/ RLA File :05/23/040/00325/AM15/ Lic.No/Date:0510391947 12.11.2014 Defer Date:14.06.2016 Decision :Deferred. 73

Case No.:77/18/82-

ALC4/2014 Party Name:LAKELAND CHEMICALS (INDIA) LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01443/AM15/ RLA File :03/95/040/00629/AM14/ Lic.No/Date:0310790966 12.11.2014 Defer Date:14.06.2016 Decision :Deferred. 74

Case No.:65/18/82-

ALC4/2014 Party Name:DEEPAK NITRITE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01431/AM15/ RLA File :34/24/040/00199/AM15/ Lic.No/Date:3410040677 13.11.2014 Defer Date:14.06.2016 Decision :Deferred. 75

Case No.:42/18/82-

ALC4/2014 Party Name:LAKELAND CHEMICALS (INDIA) LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01408/AM15/ RLA File :03/95/040/00628/AM14/ Lic.No/Date:0310791049 13.11.2014 Defer Date:14.06.2016 Decision :Deferred. 76

Case No.:65/15/82-

ALC4/2014 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01352/AM15/ RLA File :05/23/040/00360/AM15/ Lic.No/Date:0510392011 14.11.2014 Defer Date:14.06.2016 Decision :Deferred for want of comments from AYUSH. 77

Case No.:52/15/82-

ALC4/2014 Party Name:MYLAN Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01339/AM15/ RLA File :09/24/040/00408/AM15/ Lic.No/Date:0910061280 20.11.2014 Defer Date:14.06.2016 78

Case No.:16/18/82-

ALC4/2014 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01382/AM15/ RLA File :03/94/040/00789/AM15/ Lic.No/Date:0310791300 21.11.2014 Defer Date:14.06.2016 Decision :Deferred. 79

Case No.:74/18/82-

ALC4/2014 Party Name:ADESHWAR MEDITEX PVT. LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01440/AM15/ RLA File :03/94/040/00814/AM15/ Lic.No/Date:0310791373 25.11.2014 Defer Date:14.06.2016

13 Decision :Deferred. 80

Case No.:18/18/82-

ALC4/2014 Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01384/AM15/ RLA File :03/94/040/00792/AM15/ Lic.No/Date:0310791374 25.11.2014 Defer Date:14.06.2016 Decision :Deferred. 81

Case No.:15/2/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00030/AM16/ RLA File :03/95/040/00639/AM15/ Lic.No/Date:0310791416 25.11.2014 Defer Date:14.06.2016 82

Case No.:11/2/82-

ALC4/2015 Party Name:JUBILANT GENERICS LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00026/AM16/ RLA File :05/23/040/00370/AM15/ Lic.No/Date:0510392171 27.11.2014 Defer Date:14.06.2016 Decision :Deferred. 83

Case No.:32/2/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00032/AM17/ RLA File :03/95/040/00617/AM15/ Lic.No/Date:0310791470 27.11.2014 Defer Date:14.06.2016 Decision :Deferred. 84

Case No.:26/18/82-

ALC4/2014 Party Name:SADHANA NITRO CHEM LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01392/AM15/ RLA File :03/95/040/00714/AM15/ Lic.No/Date:0310791516 28.11.2014 Defer Date:14.06.2016 Decision :Deferred. 85

Case No.:92/18/82-

ALC4/2014 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01458/AM15/ RLA File :34/24/040/00224/AM15/ Lic.No/Date:3410040732 28.11.2014 Defer Date:14.06.2016 Decision :Deferred. 86

Case No.:154/5/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00294/AM16/ RLA File :03/95/040/00740/AM15/ Lic.No/Date:0310791735 05.12.2014 Defer Date:14.06.2016 87 Case No.:82/18/82- Party Name:ABEERS Meet No/Date:4/82- Status:Case

14 ALC4/2014 PHARMACEUTICALS PVT LTD ALC4/2016 24.05.2016 Deferred HQ File :01/82/050/01448/AM15/ RLA File :05/23/040/00413/AM15/ Lic.No/Date:0510392368 10.12.2014 Defer Date:14.06.2016 Decision : Deferred for want of comments from AYUSH. 88

Case No.:101/4/82-

ALC4/2015 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00140/AM16/ RLA File :17/24/040/00144/AM15/ Lic.No/Date:1710005998 10.12.2014 Defer Date:14.06.2016 Decision :Deferred. 89

Case No.:97/18/82-

ALC4/2014 Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01463/AM15/ RLA File :30/24/040/00041/AM15/ Lic.No/Date:3010103261 11.12.2014 Defer Date:14.06.2016 Decision :Deferred. 90

Case No.:119/18/82-

ALC4/2014 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01485/AM15/ RLA File :05/24/040/00419/AM15/ Lic.No/Date:0510392414 15.12.2014 Defer Date:14.06.2016 Decision :Deferred. 91

Case No.:224/5/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00364/AM16/ RLA File :09/24/040/00531/AM15/ Lic.No/Date:0910061427 22.12.2014 Defer Date:14.06.2016 92

Case No.:91/18/82-

ALC4/2014 Party Name:ALCHEM INTERNATIONAL LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01457/AM15/ RLA File :05/23/040/00449/AM15/ Lic.No/Date:0510392602 29.12.2014 Defer Date:14.06.2016 Decision : The Committee noted that information called for from the firm in NC meeting No.18 dated 18.2.2015 is awaited. The Committee accordingly decided to await the reply and deferred the case. 93

Case No.:84/18/82-

ALC4/2014 Party Name:HESTER BIOSCIENCES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01450/AM15/ RLA File :08/24/040/00362/AM15/ Lic.No/Date:0810134170 30.12.2014 Defer Date:14.06.2016 No.04 dated 12.06.2015 is awaited. The Committee accordingly decided to await the reply and deferred the case.

15 94

Case No.:3/1/82-ALC4/2015 Party Name:JAGSONPAL

PHARMACEUTICALS LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00003/AM16/ RLA File :05/23/040/00450/AM15/ Lic.No/Date:0510392649 01.01.2015 Defer Date:14.06.2016 No.11 dated 28.10.2015 is awaited. The Committee accordingly decided to await the reply and deferred the case. 95

Case No.:96/18/82-

ALC4/2014 Party Name:NUTRA SPECIALITIES PVT. LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01462/AM15/ RLA File :04/24/040/00248/AM15/ Lic.No/Date:0410159986 07.01.2015 Defer Date:14.06.2016 No.13 dated 27.11.2015 is awaited. The Committee accordingly decided to await the reply and deferred the case. 96

Case No.:92/5/82-

ALC4/2015 Party Name:ALKALOIDS CORPORATION Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00232/AM16/ RLA File :02/24/040/00203/AM15/ Lic.No/Date:0210205448 14.01.2015 Defer Date:14.06.2016 97

Case No.:59/5/82-

ALC4/2015 Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00199/AM16/ RLA File :03/94/040/00793/AM15/ Lic.No/Date:0310792911 14.01.2015 Defer Date:14.06.2016 Decision :Deferred. 98

Case No.:72/5/82-

ALC4/2015 Party Name:MICRO INKS PRIVATE LIMITED. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00212/AM16/ RLA File :03/95/040/00658/AM15/ Lic.No/Date:0310793017 16.01.2015 Defer Date:14.06.2016 Decision :Deferred. 99

Case No.:112/5/82-

ALC4/2015 Party Name:UNIMAX CHEMICALS PVT LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00252/AM16/ RLA File :03/95/040/00812/AM15/ Lic.No/Date:0310793039 19.01.2015 Defer Date: 07.07.2016 Decision : The committee noted that an investigation in the matter is under process. The Committee accordingly decided to defer the case. 100

Case No.:10/16/82-

ALC4/2014 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01362/AM15/ RLA File :09/24/040/00529/AM15/ Lic.No/Date:0910061548 21.01.2015 Defer Date:14.06.2016

16 101

Case No.:12/16/82-

ALC4/2014 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01364/AM15/ RLA File :09/24/040/00592/AM15/ Lic.No/Date:0910061552 21.01.2015 Defer Date:14.06.2016 102

Case No.:86/5/82-

ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00226/AM16/ RLA File :05/24/040/00489/AM15/ Lic.No/Date:0510392966 22.01.2015 Defer Date:14.06.2016 103

Case No.:204/5/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00344/AM16/ RLA File :09/24/040/00596/AM15/ Lic.No/Date:0910061555 23.01.2015 Defer Date:14.06.2016 Decision :Deferred. 104

Case No.:31/7/82-

ALC4/2015 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00636/AM16/ RLA File :05/24/040/00498/AM15/ Lic.No/Date:0510392987 27.01.2015 Defer Date:14.06.2016 Decision :Deferred. 105

Case No.:32/7/82-

ALC4/2015 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00637/AM16/ RLA File :05/24/040/00499/AM15/ Lic.No/Date:0510392988 27.01.2015 Defer Date:14.06.2016 Decision :Deferred. 106

Case No.:25/7/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00630/AM16/ RLA File :31/83/040/00144/AM15/ Lic.No/Date:3110065235 28.01.2015 Defer Date:14.06.2016 Decision :Deferred. 107

Case No.:230/5/82-

ALC4/2015 Party Name:R.K.INDUSTRIES, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00370/AM16/ RLA File :08/24/040/00394/AM15/ Lic.No/Date:0810134414 28.01.2015 Defer Date:14.06.2016 Decision :Deferred. 108 Case No.:163/5/82- ALC4/2015 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:4/82- ALC4/2016 Status:Case Deferred

17 24.05.2016 HQ File :01/82/050/00303/AM16/ RLA File :05/24/040/00503/AM15/ Lic.No/Date:0510393026 29.01.2015 Defer Date:14.06.2016 109

Case No.:169/5/82-

ALC4/2015 Party Name:TIDE INDUSTRIES Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00309/AM16/ RLA File :34/24/040/00290/AM15/ Lic.No/Date:3410040927 05.02.2015 Defer Date:14.06.2016 Decision :Deferred. 110

Case No.:91/7/82-

ALC4/2015 Party Name:SHREE GANESH REMEDIES PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00696/AM16/ RLA File :34/24/040/00295/AM15/ Lic.No/Date:3410040965 16.02.2015 Defer Date:14.06.2016 Decision :Deferred. 111

Case No.:52/19/82-

ALC4/2014 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01540/AM15/ RLA File :05/24/040/00273/AM15/ Lic.No/Date:0510393248 17.02.2015 Defer Date:14.06.2016 Decision :Deferred. 112

Case No.:38/7/82-

ALC4/2015 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00643/AM16/ RLA File :09/24/040/00640/AM15/ Lic.No/Date:0910061628 18.02.2015 Defer Date:14.06.2016 113

Case No.:332/5/82-

ALC4/2015 Party Name:O C SPECIALITIES PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00472/AM16/ RLA File :03/95/040/00991/AM15/ Lic.No/Date:0310794000 19.02.2015 Defer Date:14.06.2016 Decision :Deferred. 114

Case No.:280/5/82-

ALC4/2015 Party Name:FERMENTA BIOTECH LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00420/AM16/ RLA File :03/94/040/01110/AM15/ Lic.No/Date:0310794101 24.02.2015 Defer Date:14.06.2016 115

Case No.:298/5/82-

ALC4/2015 Party Name:MEDICEF PHARMA, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00438/AM16/ RLA File :22/24/040/00095/AM15/ Lic.No/Date:2210015200 27.02.2015 Defer Date:14.06.2016

18 116

Case No.:444/5/82-

ALC4/2015 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00584/AM16/ RLA File :03/94/040/01132/AM15/ Lic.No/Date:0310794412 09.03.2015 Defer Date:14.06.2016 117

Case No.:413/5/82-

ALC4/2015 Party Name:INDO AMINES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00553/AM16/ RLA File :03/94/040/01145/AM15/ Lic.No/Date:0310794545 12.03.2015 Defer Date:14.06.2016 Decision :Deferred. 118

Case No.:106/7/82-

ALC4/2015 Party Name:ALCHEMIE LABORATORIES Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00711/AM16/ RLA File :03/94/040/00812/AM15/ Lic.No/Date:0310794612 16.03.2015 Defer Date:14.06.2016 119

Case No.:16/1/82-

ALC4/2015 Party Name:HETERO LABS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01542/AM15/ RLA File :09/24/040/00703/AM15/ Lic.No/Date:0910061716 17.03.2015 Defer Date:14.06.2016 120

Case No.:427/5/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00567/AM16/ RLA File :03/95/040/01071/AM15/ Lic.No/Date:0310794916 26.03.2015 Defer Date:14.06.2016 121

Case No.:431/5/82-

ALC4/2015 Party Name:EUROLIFE HEALTHCARE PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00571/AM16/ RLA File :03/94/040/01086/AM15/ Lic.No/Date:0310794964 27.03.2015 Defer Date:14.06.2016 122

Case No.:9/1/82-ALC4/2015 Party Name:VIVIMED

LABS ( ALATHUR) PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00009/AM16/ RLA File :04/24/040/00292/AM15/ Lic.No/Date:0410160364 30.03.2015 Defer Date:14.06.2016 123 Case No.:448/5/82- Party Name:AARTI Meet No/Date:4/82- Status:Case

19 ALC4/2015 INDUSTRIES LIMITED ALC4/2016 24.05.2016 Deferred HQ File :01/82/050/00588/AM16/ RLA File :03/94/040/01211/AM15/ Lic.No/Date:0310795048 31.03.2015 Defer Date:14.06.2016 124

Case No.:12/7/82-

ALC4/2015 Party Name:SHILPA MEDICARE LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00617/AM16/ RLA File :07/24/040/00002/AM16/ Lic.No/Date:0710108028 15.04.2015 Defer Date:14.06.2016 Decision : 125

Case No.:32/5/82-

ALC4/2015 Party Name:LANTECH PHARMACEUTICALS LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00172/AM16/ RLA File :09/24/040/00011/AM16/ Lic.No/Date:0910061900 20.04.2015 Defer Date:14.06.2016 Decision : 126

Case No.:8/2/82-ALC4/2015 Party Name:HETERO LABS

LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00023/AM16/ RLA File :09/24/040/00043/AM16/ Lic.No/Date:0910061906 21.04.2015 Defer Date:14.06.2016 127

Case No.:147/7/82-ALC4/2015 Party Name:INDOCO

REMEDIES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/00752/AM16/ RLA File :03/94/040/00036/AM16/ Lic.No/Date:0310795446 21.04.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/775/2015-PI(Norms) dated 02.05.2016, uploaded 128

Case No.:174/7/82-

ALC4/2015 Party Name:S M B CORPORATION OF INDIA Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00779/AM16/ RLA File :03/95/040/00039/AM16/ Lic.No/Date:0310795601 28.04.2015 Defer Date:14.06.2016 129

Case No.:62/8/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00858/AM16/ RLA File :09/24/040/00028/AM16/ Lic.No/Date:0910061955 01.05.2015 Defer Date:14.06.2016 130 Case No.:50/7/82- ALC4/2015 Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:4/82- ALC4/2016 Status:Case Deferred

20 24.05.2016 HQ File :01/82/050/00655/AM16/ RLA File :09/24/040/00041/AM16/ Lic.No/Date:0910061976 06.05.2015 Defer Date:14.06.2016 131

Case No.:4/7/82-ALC4/2015 Party Name:POSY

PHARMACHEM PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/00609/AM16/ RLA File :08/24/040/00006/AM16/ Lic.No/Date:0810135194 06.05.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/732/2015-PI(Norms) dated 28.04.2016, uploaded 132

Case No.:3/3/82-ALC4/2015 Party Name:RA CHEM

PHARMA LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00033/AM16/ RLA File :09/24/040/00077/AM16/ Lic.No/Date:0910061994 07.05.2015 Defer Date:14.06.2016 133

Case No.:108/7/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00713/AM16/ RLA File :03/95/040/00003/AM16/ Lic.No/Date:0310795745 07.05.2015 Defer Date:14.06.2016 134

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

PARENTERALS PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/00612/AM16/ RLA File :08/24/040/00017/AM16/ Lic.No/Date:0810135225 08.05.2015 Defer Date: Decision :Approve meeting 02/17 Sl.No.178. 135

Case No.:8/7/82-ALC4/2015 Party Name:SWISS

PARENTERALS PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/00613/AM16/ RLA File :08/24/040/00018/AM16/ Lic.No/Date:0810135226 08.05.2015 Defer Date: Decision :Approve meeting 02/17 Sl.No.179. 136

Case No.:117/7/82-

ALC4/2015 Party Name:ZIM LABORATORIES LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/00722/AM16/ RLA File :03/95/040/00079/AM16/ Lic.No/Date:0310795788 08.05.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/766/2015-PI(Norms) dated 26.04.2016, uploaded

21 137

Case No.:15/7/82-

ALC4/2015 Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00620/AM16/ RLA File :52/24/040/00007/AM16/ Lic.No/Date:5210041517 11.05.2015 Defer Date:14.06.2016 138

Case No.:129/7/82-

ALC4/2015 Party Name:NATIONAL TUBE INDUSTRIES, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00734/AM16/ RLA File :03/95/040/00073/AM16/ Lic.No/Date:0310795930 14.05.2015 Defer Date:14.06.2016 139

Case No.:164/7/82-

ALC4/2015 Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00769/AM16/ RLA File :03/94/040/00026/AM16/ Lic.No/Date:0310795971 18.05.2015 Defer Date:14.06.2016 Decision :Deferred. 140

Case No.:109/7/82-

ALC4/2015 Party Name:ZIM LABORATORIES LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00714/AM16/ RLA File :03/95/040/00103/AM16/ Lic.No/Date:0310795994 18.05.2015 Defer Date:14.06.2016 Decision :Deferred. 141

Case No.:133/7/82-

ALC4/2015 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00738/AM16/ RLA File :03/94/040/00085/AM16/ Lic.No/Date:0310796048 20.05.2015 Defer Date:14.06.2016 142

Case No.:102/7/82-

ALC4/2015 Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00707/AM16/ RLA File :30/24/040/00006/AM16/ Lic.No/Date:3010103498 21.05.2015 Defer Date:14.06.2016 Decision :Deferred. 143

Case No.:199/5/82-

ALC4/2015 Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00339/AM16/ RLA File :04/24/040/00040/AM16/ Lic.No/Date:0410160570 21.05.2015 Defer Date:14.06.2016 144

Case No.:55/13/82-

ALC4/2015 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred

22 HQ File :01/82/050/01018/AM16/ RLA File :07/24/040/00036/AM16/ Lic.No/Date:0710108251 22.05.2015 Defer Date:14.06.2016 Decision :Deferred. 145

Case No.:5/4/82-ALC4/2015 Party Name:HETERO LABS

LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00044/AM16/ RLA File :09/24/040/00116/AM16/ Lic.No/Date:0910062066 25.05.2015 Defer Date:14.06.2016 146

Case No.:176/7/82-

ALC4/2015 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00781/AM16/ RLA File :03/94/040/00124/AM16/ Lic.No/Date:0310796194 26.05.2015 Defer Date:14.06.2016 Decision :Deferred. 147

Case No.:124/7/82-

ALC4/2015 Party Name:PRIVI ORGANICS LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00729/AM16/ RLA File :03/95/040/00114/AM16/ Lic.No/Date:0310796233 27.05.2015 Defer Date:14.06.2016 Decision :Deferred. 148

Case No.:100/7/82-

ALC4/2015 Party Name:SHREE GANESH REMEDIES PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00705/AM16/ RLA File :34/24/040/00024/AM16/ Lic.No/Date:3410041261 28.05.2015 Defer Date:14.06.2016 Decision :Deferred. 149

Case No.:188/7/82-

ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00793/AM16/ RLA File :08/24/040/00034/AM16/ Lic.No/Date:0810135421 02.06.2015 Defer Date:14.06.2016 Decision :Deferred. 150

Case No.:142/7/82-

ALC4/2015 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00747/AM16/ RLA File :03/94/040/00159/AM16/ Lic.No/Date:0310796401 03.06.2015 Defer Date:14.06.2016 Decision : Deferred 151

Case No.:110/7/82-

ALC4/2015 Party Name:RISHABH METALS & CHEMICALS PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00715/AM16/ RLA File :03/95/040/00051/AM16/ Lic.No/Date:0310796383 03.06.2015 Defer Date:14.06.2016 Decision :Deferred.

23 152

Case No.:17/7/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00622/AM16/ RLA File :05/24/040/00078/AM16/ Lic.No/Date:0510394418 03.06.2015 Defer Date:14.06.2016 Decision : The Committee decided to call for information from the firm based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/781/2015-PI(Norms) dated 26.04.2016, uploaded at the end of these minutes and deferred the case. 153

Case No.:67/7/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00672/AM16/ RLA File :09/24/040/00105/AM16/ Lic.No/Date:0910062138 05.06.2015 Defer Date:14.06.2016 Decision : Deferred for want of comment from DoP. 154

Case No.:13/9/82-

ALC4/2015 Party Name:SHILPA MEDICARE LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00949/AM16/ RLA File :07/24/040/00081/AM16/ Lic.No/Date:0710108327 05.06.2015 Defer Date:14.06.2016 155

Case No.:121/7/82-

ALC4/2015 Party Name:UNIMARK REMEDIES LIMITED., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00726/AM16/ RLA File :03/95/040/00715/AM15/ Lic.No/Date:0310796458 05.06.2015 Defer Date:14.06.2016 No.17 dated 27.1.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 156

Case No.:123/7/82-

ALC4/2015 Party Name:UNIMARK REMEDIES LIMITED., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00728/AM16/ RLA File :03/95/040/00582/AM15/ Lic.No/Date:0310796457 05.06.2015 Defer Date:14.06.2016 No.17 dated 27.1.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 157

Case No.:60/4/82-

ALC4/2016 Party Name:ADCOCK INGRAM LTD, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00123/AM17/ RLA File :07/24/040/00071/AM16/ Lic.No/Date:0710108351 10.06.2015 Defer Date:14.06.2016 158

Case No.:14/9/82-

ALC4/2015 Party Name:SHILPA MEDICARE LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:0710108349 Defer

24 :01/82/050/00950/AM16/ :07/24/040/00078/AM16/ 10.06.2015 Date:14.06.2016 159

Case No.:65/7/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00670/AM16/ RLA File :09/24/040/00164/AM16/ Lic.No/Date:0910062163 10.06.2015 Defer Date:14.06.2016 Decision :Deferred. 160

Case No.:66/7/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00671/AM16/ RLA File :09/24/040/00162/AM16/ Lic.No/Date:0910062162 10.06.2015 Defer Date:14.06.2016 Decision :Deferred. 161

Case No.:20/13/82-

ALC4/2015 Party Name:JAYANT AGRO ORGANICS LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00983/AM16/ RLA File :03/94/040/00169/AM16/ Lic.No/Date:0310796563 11.06.2015 Defer Date:14.06.2016 Decision :Deferred. 162

Case No.:159/7/82-

ALC4/2015 Party Name:VIJAY PERFUMES PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00764/AM16/ RLA File :03/95/040/00985/AM15/ Lic.No/Date:0310796576 11.06.2015 Defer Date:14.06.2016 Decision :Deferred. 163

Case No.:87/7/82-

ALC4/2015 Party Name:VISION DRUGS PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00692/AM16/ RLA File :09/24/040/00102/AM16/ Lic.No/Date:0910062168 11.06.2015 Defer Date:14.06.2016 Decision : The Committee decided call for information as per Appendix 33 and past production consumption data vis-a-vis actual consumption of imported inputs duly certified by Central Excise Authorities. It was also observed that the quantities of import mentioned by the applicant appear to be disproportionately high. Accordingly, firm is to submit its version on immediate basis. 164

Case No.:42/13/82-

ALC4/2015 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01005/AM16/ RLA File :03/94/040/00177/AM16/ Lic.No/Date:0310796604 15.06.2015 Defer Date:14.06.2016 Decision :Deferred. 165

Case No.:48/19/82-

ALC4/2015 Party Name:RAJ DHANVANTRY PHARMACY Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01529/AM16/ RLA File :24/24/040/00007/AM16/ Lic.No/Date:2410041748 15.06.2015 Defer Date:14.06.2016

25 Decision :Deferred. 166

Case No.:41/13/82-

ALC4/2015 Party Name:DANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01004/AM16/ RLA File :03/94/040/00111/AM16/ Lic.No/Date:0310796667 16.06.2015 Defer Date:14.06.2016 Decision :Deferred. 167

Case No.:52/7/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00657/AM16/ RLA File :05/23/040/00107/AM16/ Lic.No/Date:0510394590 17.06.2015 Defer Date:14.06.2016 Decision :Deferred. 168

Case No.:43/13/82-

ALC4/2015 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01006/AM16/ RLA File :03/94/040/00178/AM16/ Lic.No/Date:0310796712 18.06.2015 Defer Date:14.06.2016 Decision :Deferred. 169

Case No.:15/9/82-

ALC4/2015 Party Name:KDAC CHEM PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00951/AM16/ RLA File :34/24/040/00069/AM16/ Lic.No/Date:3410041310 22.06.2015 Defer Date:14.06.2016 Decision :Deferred. 170

Case No.:83/13/82-

ALC4/2015 Party Name:RIDDHI PHARMA Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01046/AM16/ RLA File :34/24/040/00087/AM16/ Lic.No/Date:3410041313 23.06.2015 Defer Date:14.06.2016 Decision :Deferred. 171

Case No.:15/13/82-

ALC4/2015 Party Name:ALIVIRA ANIMAL HEALTH LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00978/AM16/ RLA File :03/94/040/00219/AM16/ Lic.No/Date:0310796797 24.06.2015 Defer Date:14.06.2016 Decision : Deferred for want of comment from DBT. 172

Case No.:82/19/82-

ALC4/2015 Party Name:SIDDHARTH CARBOCHEM PRODUCTS LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01563/AM16/ RLA File :03/95/040/00667/AM15/ Lic.No/Date:0310796830 24.06.2015 Defer Date:14.06.2016 Decision :The Committee decided to call for information based on the recommendation forwarded by D/o Pharmaceuticals vide O.M.No.35011/874/2015-PI(Norms) dated 24.05.2016, uploaded at the end of these minutes and deferred the case.

26 173

Case No.:72/7/82-

ALC4/2015 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00677/AM16/ RLA File :05/24/040/00104/AM16/ Lic.No/Date:0510394704 25.06.2015 Defer Date:14.06.2016 Decision :Deferred. 174

Case No.:76/7/82-

ALC4/2015 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00681/AM16/ RLA File :05/24/040/00103/AM16/ Lic.No/Date:0510394703 25.06.2015 Defer Date:14.06.2016 Decision :Deferred. 175

Case No.:75/7/82-

ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00680/AM16/ RLA File :05/24/040/00122/AM16/ Lic.No/Date:0510394696 25.06.2015 Defer Date:14.06.2016 176

Case No.:78/7/82-

ALC4/2015 Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00683/AM16/ RLA File :02/24/040/00028/AM16/ Lic.No/Date:0210205920 25.06.2015 Defer Date:14.06.2016 177

Case No.:109/8/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00905/AM16/ RLA File :03/95/040/00038/AM16/ Lic.No/Date:0310796997 01.07.2015 Defer Date:14.06.2016 178

Case No.:108/14/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01244/AM16/ RLA File :09/24/040/00183/AM16/ Lic.No/Date:0910062267 01.07.2015 Defer Date:14.06.2016 Decision :Deferred. 179

Case No.:10/13/82-

ALC4/2015 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00973/AM16/ RLA File :03/94/040/00229/AM16/ Lic.No/Date:0310797018 02.07.2015 Defer Date:14.06.2016 Decision :Deferred. 180 Case No.:11/13/82- ALC4/2015 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:4/82- ALC4/2016 Status:Case Deferred

27 24.05.2016 HQ File :01/82/050/00974/AM16/ RLA File :03/94/040/00228/AM16/ Lic.No/Date:0310797020 02.07.2015 Defer Date:14.06.2016 Decision : Deferred . 181

Case No.:105/14/82-

ALC4/2015 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01241/AM16/ RLA File :09/24/040/00191/AM16/ Lic.No/Date:0910062299 03.07.2015 Defer Date:14.06.2016 182

Case No.:24/13/82-

ALC4/2015 Party Name:DANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00987/AM16/ RLA File :03/94/040/00226/AM16/ Lic.No/Date:0310797092 07.07.2015 Defer Date:14.06.2016 183

Case No.:32/13/82-

ALC4/2015 Party Name:FDC LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/00995/AM16/ RLA File :03/94/040/00263/AM16/ Lic.No/Date:0310797090 07.07.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/704/2015-PI(Norms) dated 29.4.2016 , uploaded 184

Case No.:82/13/82-

ALC4/2015 Party Name:PAB ORGANICS PVT.LTD, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01045/AM16/ RLA File :34/24/040/00084/AM16/ Lic.No/Date:3410041360 07.07.2015 Defer Date:14.06.2016 Decision :Deferred. 185

Case No.:23/13/82-

ALC4/2015 Party Name:K V AROCHEM PVT. LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00986/AM16/ RLA File :03/94/040/00284/AM16/ Lic.No/Date:0310797268 15.07.2015 Defer Date:14.06.2016 Decision :Deferred. 186

Case No.:20/16/82-

ALC4/2015 Party Name:MYLAN Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01340/AM16/ RLA File :09/24/040/00032/AM16/ Lic.No/Date:0910062338 15.07.2015 Defer Date:14.06.2016 187

Case No.:22/13/82-

ALC4/2015 Party Name:BLISS INDASI LIFESCIENCES PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred

28 HQ File :01/82/050/00985/AM16/ RLA File :03/94/040/00282/AM16/ Lic.No/Date:0310797355 17.07.2015 Defer Date:14.06.2016 188

Case No.:119/8/82-

ALC4/2015 Party Name:SI GROUP INDIA LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00915/AM16/ RLA File :03/95/040/00322/AM16/ Lic.No/Date:0310797595 23.07.2015 Defer Date:14.06.2016 Decision :Deferred. 189

Case No.:115/13/82-

ALC4/2015 Party Name:FERMENTA BIOTECH LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01078/AM16/ RLA File :03/94/040/00038/AM16/ Lic.No/Date:0310797627 24.07.2015 Defer Date:14.06.2016 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/761/2015-PI(Norms) dated 05.05.2016, uploaded at the end of these minutes and deferred the case. 190

Case No.:73/8/82-

ALC4/2015 Party Name:RECKITT BENCKISER HEALTHCARE INDIA LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00869/AM16/ RLA File :05/24/040/00213/AM16/ Lic.No/Date:0510395102 28.07.2015 Defer Date:14.06.2016 191

Case No.:69/13/82-

ALC4/2015 Party Name:PI INDUSTRIES LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01032/AM16/ RLA File :13/24/040/00016/AM16/ Lic.No/Date:1310047933 29.07.2015 Defer Date:14.06.2016 Decision :Deferred. 192

Case No.:92/13/82-

ALC4/2015 Party Name:INFINITY LABORATORIES PVT.LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/01055/AM16/ RLA File :22/24/040/00027/AM16/ Lic.No/Date:2210015273 31.07.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/753/2015-PI(Norms) dated 05.05.2016, uploaded 193

Case No.:116/13/82-

ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01079/AM16/ RLA File :03/94/040/00215/AM16/ Lic.No/Date:0310797864 31.07.2015 Defer Date:14.06.2016 Decision :Deferred. 194 Case No.:49/19/82- Party Name:JODAS EXPOIM Meet No/Date:4/82- Status:Case

29 ALC4/2015 PVT.LTD., ALC4/2016 24.05.2016 Approved HQ File :01/82/050/01530/AM16/ RLA File :05/23/040/00185/AM16/ Lic.No/Date:0510395140 31.07.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/696/2015-PI(Norms) dated 18.05.2016, uploaded 195

Case No.:114/13/82-

ALC4/2015 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01077/AM16/ RLA File :03/94/040/00258/AM16/ Lic.No/Date:0310797898 03.08.2015 Defer Date:14.06.2016 Decision :Deferred. 196

Case No.:113/13/82-

ALC4/2015 Party Name:K V AROCHEM PVT. LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01076/AM16/ RLA File :03/94/040/00335/AM16/ Lic.No/Date:0310797897 03.08.2015 Defer Date:14.06.2016 Decision :Deferred. 197

Case No.:112/13/82-

ALC4/2015 Party Name:K V AROCHEM PVT. LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01075/AM16/ RLA File :03/94/040/00345/AM16/ Lic.No/Date:0310797937 04.08.2015 Defer Date:14.06.2016 Decision :Deferred. 198

Case No.:75/13/82-

ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01038/AM16/ RLA File :05/24/040/00215/AM16/ Lic.No/Date:0510395160 04.08.2015 Defer Date:14.06.2016 199

Case No.:78/13/82-

ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01041/AM16/ RLA File :05/24/040/00219/AM16/ Lic.No/Date:0510395169 04.08.2015 Defer Date:14.06.2016 200

Case No.:109/13/82-

ALC4/2015 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01072/AM16/ RLA File :03/94/040/00170/AM16/ Lic.No/Date:0310797954 05.08.2015 Defer Date:14.06.2016 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/773/2015-PI(Norms) dated 26.04.2016, uploaded at the end of these minutes and deferred the case.

30 201

Case No.:12/18/82-

ALC4/2015 Party Name:OMTECH CHEMICAL INDUSTRIES PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01477/AM16/ RLA File :03/95/040/00345/AM16/ Lic.No/Date:0310797967 05.08.2015 Defer Date:14.06.2016 202

Case No.:50/13/82-

ALC4/2015 Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01013/AM16/ RLA File :04/24/040/00095/AM16/ Lic.No/Date:0410160884 06.08.2015 Defer Date:14.06.2016 203

Case No.:2/21/82-

ALC4/2015 Party Name:AUROLAB Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01707/AM16/ RLA File :35/24/040/00022/AM16/ Lic.No/Date:3510044782 06.08.2015 Defer Date:14.06.2016 204

Case No.:110/13/82-

ALC4/2015 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01073/AM16/ RLA File :03/94/040/00350/AM16/ Lic.No/Date:0310798096 12.08.2015 Defer Date:14.06.2016 205

Case No.:111/13/82-

ALC4/2015 Party Name:HEMA DYE CHEM PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01074/AM16/ RLA File :03/94/040/00305/AM16/ Lic.No/Date:0310798134 13.08.2015 Defer Date:14.06.2016 206

Case No.:91/13/82-

ALC4/2015 Party Name:VENUS REMEDIES LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/01054/AM16/ RLA File :22/24/040/00016/AM16/ Lic.No/Date:2210015282 13.08.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/784/2015-PI(Norms) dated 29.04.2016, uploaded 207

Case No.:79/13/82-

ALC4/2015 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01042/AM16/ RLA File :52/24/040/00034/AM16/ Lic.No/Date:5210041610 14.08.2015 Defer Date:14.06.2016

31 208

Case No.:57/13/82-

ALC4/2015 Party Name:VENUS REMEDIES LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01020/AM16/ RLA File :22/24/040/00013/AM16/ Lic.No/Date:2210015284 14.08.2015 Defer Date:14.06.2016 209

Case No.:127/13/82-

ALC4/2015 Party Name:ASTEC LIFESCIENCES LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01090/AM16/ RLA File :03/94/040/00878/AM15/ Lic.No/Date:0310798205 17.08.2015 Defer Date:14.06.2016 Decision : DoP vide letter 5.5.2016 has informed that case is not concerned with DoP. Therefore case is deferred for want of comments from C&PC. 210

Case No.:60/13/82-

ALC4/2015 Party Name:HELLO PAINTS (P) LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01023/AM16/ RLA File :05/23/040/00204/AM16/ Lic.No/Date:0510395351 18.08.2015 Defer Date:14.06.2016 211

Case No.:126/13/82-

ALC4/2015 Party Name:ASTEC LIFESCIENCES LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01089/AM16/ RLA File :03/94/040/00879/AM15/ Lic.No/Date:0310798319 20.08.2015 Defer Date:14.06.2016 Decision : DoP vide letter 5.5.2016 has informed that case is not concerned with DoP. Therefore case is deferred for want of comments from C&PC. 212

Case No.:61/13/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01024/AM16/ RLA File :05/23/040/00218/AM16/ Lic.No/Date:0510395388 20.08.2015 Defer Date:14.06.2016 213

Case No.:62/13/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01025/AM16/ RLA File :05/23/040/00212/AM16/ Lic.No/Date:0510395383 20.08.2015 Defer Date:14.06.2016 214

Case No.:161/13/82-

ALC4/2015 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01124/AM16/ RLA File :03/95/040/00274/AM16/ Lic.No/Date:0310798374 21.08.2015 Defer Date:14.06.2016 215 Case No.:130/13/82- ALC4/2015 Party Name:INDOCO REMEDIES LIMITED Meet No/Date:4/82- ALC4/2016 Status:Case Approved

32 24.05.2016 HQ File :01/82/050/01093/AM16/ RLA File :03/94/040/00413/AM16/ Lic.No/Date:0310798392 24.08.2015 Defer Date:14.06.2016 Pharmaceuticals forwarded vide O.M.No.35011/775/2015-PI(Norms) dated 02.05.2016, uploaded 216

Case No.:77/13/82-

ALC4/2015 Party Name:ARKRAY HEALTHCARE PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01040/AM16/ RLA File :52/24/040/00038/AM16/ Lic.No/Date:5210041620 27.08.2015 Defer Date:14.06.2016 Decision : Committee decided to send a copy of application to DBT. 217

Case No.:120/13/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01083/AM16/ RLA File :03/94/040/00279/AM16/ Lic.No/Date:0310798629 03.09.2015 Defer Date:14.06.2016 218

Case No.:84/14/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01220/AM16/ RLA File :05/24/040/00262/AM16/ Lic.No/Date:0510395506 03.09.2015 Defer Date:14.06.2016 219

Case No.:59/4/82-

ALC4/2016 Party Name:ADCOCK INGRAM LTD, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00122/AM17/ RLA File :07/24/040/00180/AM16/ Lic.No/Date:0710108694 07.09.2015 Defer Date:14.06.2016 220

Case No.:8/9/82-ALC4/2015 Party Name:BEST VALUE

CHEM PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00944/AM16/ RLA File :34/24/040/00155/AM16/ Lic.No/Date:3410041496 09.09.2015 Defer Date:14.06.2016 221

Case No.:10/9/82-

ALC4/2015 Party Name:ALKYL AMINES CHEMICALS LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00946/AM16/ RLA File :03/94/040/00355/AM16/ Lic.No/Date:0310798806 10.09.2015 Defer Date:14.06.2016 222

Case No.:20/9/82-

ALC4/2015 Party Name:SUPREET CHEMICALS PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred

33 HQ File :01/82/050/00956/AM16/ RLA File :03/95/040/00424/AM16/ Lic.No/Date:0310798995 22.09.2015 Defer Date:14.06.2016 223

Case No.:51/19/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01532/AM16/ RLA File :03/95/040/00430/AM16/ Lic.No/Date:0310799076 28.09.2015 Defer Date:14.06.2016 224

Case No.:12/19/82-

ALC4/2015 Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01492/AM16/ RLA File :04/24/040/00154/AM16/ Lic.No/Date:0410161070 01.10.2015 Defer Date:14.06.2016 225

Case No.:44/4/82-

ALC4/2016 Party Name:KUBO COMBUSTION EFFICIENCY CHEMICALS PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00107/AM17/ RLA File :03/94/040/00468/AM16/ Lic.No/Date:0310799183 05.10.2015 Defer Date:14.06.2016 226

Case No.:130/14/82-

ALC4/2015 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01266/AM16/ RLA File :05/24/040/00317/AM16/ Lic.No/Date:0510395874 09.10.2015 Defer Date:14.06.2016 227

Case No.:56/2/82-

ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00056/AM17/ RLA File :07/24/040/00123/AM16/ Lic.No/Date:0710108886 13.10.2015 Defer Date:14.06.2016 228

Case No.:135/13/82-

ALC4/2015 Party Name:MYLAN Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01098/AM16/ RLA File :09/24/040/00408/AM16/ Lic.No/Date:0910062740 14.10.2015 Defer Date:14.06.2016 229

Case No.:24/16/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01344/AM16/ RLA File :09/24/040/00380/AM16/ Lic.No/Date:0910062727 14.10.2015 Defer Date:14.06.2016

34 230

Case No.:136/13/82-

ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01099/AM16/ RLA File :08/24/040/00207/AM16/ Lic.No/Date:0810136320 16.10.2015 Defer Date:14.06.2016 231

Case No.:46/19/82-

ALC4/2015 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01527/AM16/ RLA File :09/24/040/00438/AM16/ Lic.No/Date:0910062744 19.10.2015 Defer Date:14.06.2016 232

Case No.:138/13/82-

ALC4/2015 Party Name:ARCHIMEDIS LABORATORIES PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/01101/AM16/ RLA File :09/24/040/00320/AM16/ Lic.No/Date:0910062756 20.10.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/762/2015-PI(Norms) dated 05.05.2016, uploaded 233

Case No.:77/16/82-

ALC4/2015 Party Name:LACTOSE (INDIA) LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01397/AM16/ RLA File :03/95/040/00481/AM16/ Lic.No/Date:0310799561 20.10.2015 Defer Date:14.06.2016 234

Case No.:140/13/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01103/AM16/ RLA File :03/95/040/00503/AM16/ Lic.No/Date:0310799583 21.10.2015 Defer Date:14.06.2016 235

Case No.:141/13/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01104/AM16/ RLA File :03/95/040/00504/AM16/ Lic.No/Date:0310799629 23.10.2015 Defer Date:14.06.2016 236

Case No.:142/13/82-

ALC4/2015 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01105/AM16/ RLA File :09/24/040/00443/AM16/ Lic.No/Date:0910062774 27.10.2015 Defer Date:14.06.2016

35 237

Case No.:29/21/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/01734/AM16/ RLA File :09/24/040/00448/AM16/ Lic.No/Date:0910062788 28.10.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/742/2015-PI(Norms) dated 29.04.2016, uploaded 238

Case No.:73/19/82-

ALC4/2015 Party Name:GALAXY SURFACTANTS LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01554/AM16/ RLA File :03/94/040/00575/AM16/ Lic.No/Date:0310799849 29.10.2015 Defer Date:14.06.2016 239

Case No.:147/13/82-

ALC4/2015 Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01110/AM16/ RLA File :08/24/040/00241/AM16/ Lic.No/Date:0810136382 29.10.2015 Defer Date:14.06.2016 240

Case No.:152/13/82-

ALC4/2015 Party Name:ARCHIMEDIS LABORATORIES PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/01115/AM16/ RLA File :09/24/040/00319/AM16/ Lic.No/Date:0910062806 30.10.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/831/2015-PI(Norms) dated 18.05.2016, uploaded 241

Case No.:64/19/82-

ALC4/2015 Party Name:INDO AMINES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01545/AM16/ RLA File :03/94/040/00240/AM16/ Lic.No/Date:0310799907 30.10.2015 Defer Date:14.06.2016 242

Case No.:65/19/82-

ALC4/2015 Party Name:INDO AMINES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01546/AM16/ RLA File :03/94/040/00059/AM16/ Lic.No/Date:0310799906 30.10.2015 Defer Date:14.06.2016 243

Case No.:44/19/82-

ALC4/2015 Party Name:MSN PHARMACHEM PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved

36 HQ File :01/82/050/01525/AM16/ RLA File :09/24/040/00424/AM16/ Lic.No/Date:0910062805 30.10.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/871/2015-PI(Norms) dated 24.5.2016 , uploaded 244

Case No.:153/13/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01116/AM16/ RLA File :34/24/040/00199/AM16/ Lic.No/Date:3410041644 02.11.2015 Defer Date:14.06.2016 245

Case No.:66/19/82-

ALC4/2015 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01547/AM16/ RLA File :03/94/040/00582/AM16/ Lic.No/Date:0310799943 02.11.2015 Defer Date:14.06.2016 246

Case No.:54/19/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01535/AM16/ RLA File :03/94/040/00590/AM16/ Lic.No/Date:0310799952 02.11.2015 Defer Date:14.06.2016 247

Case No.:67/19/82-

ALC4/2015 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01548/AM16/ RLA File :03/94/040/00553/AM16/ Lic.No/Date:0310799932 02.11.2015 Defer Date:14.06.2016 248

Case No.:70/19/82-

ALC4/2015 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01551/AM16/ RLA File :03/94/040/00481/AM16/ Lic.No/Date:0310799926 02.11.2015 Defer Date:14.06.2016 249

Case No.:154/13/82-

ALC4/2015 Party Name:DR REDDYS Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01117/AM16/ RLA File :09/24/040/00460/AM16/ Lic.No/Date:0910062821 03.11.2015 Defer Date:14.06.2016 250 Case No.:156/13/82- ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:4/82- ALC4/2016 Status:Case Deferred

37 24.05.2016 HQ File :01/82/050/01119/AM16/ RLA File :09/24/040/00464/AM16/ Lic.No/Date:0910062832 03.11.2015 Defer Date:14.06.2016 251

Case No.:38/21/82-

ALC4/2015 Party Name:VINS BIOPRODUCTS LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01743/AM16/ RLA File :09/24/040/00442/AM16/ Lic.No/Date:0910062831 03.11.2015 Defer Date:14.06.2016 252

Case No.:159/13/82-

ALC4/2015 Party Name:CHEMCON SPECIALITY CHEMICALS P LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01122/AM16/ RLA File :34/24/040/00205/AM16/ Lic.No/Date:3410041650 04.11.2015 Defer Date:14.06.2016 253

Case No.:53/19/82-

ALC4/2015 Party Name:INDOCO REMEDIES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/01534/AM16/ RLA File :03/94/040/00557/AM16/ Lic.No/Date:0310800023 04.11.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/841/2015-PI(Norms) dated 18.05.2016, uploaded 254

Case No.:57/19/82-

ALC4/2015 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01538/AM16/ RLA File :03/94/040/00443/AM16/ Lic.No/Date:0310800060 05.11.2015 Defer Date:14.06.2016 255

Case No.:108/16/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/01428/AM16/ RLA File :05/23/040/00330/AM16/ Lic.No/Date:0510396254 05.11.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/696/2015-PI(Norms) dated 18.05.2016, uploaded 256

Case No.:163/13/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01126/AM16/ RLA File :09/24/040/00479/AM16/ Lic.No/Date:0910062838 06.11.2015 Defer Date:14.06.2016

38 257

Case No.:18/21/82-

ALC4/2015 Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01723/AM16/ RLA File :09/24/040/00487/AM16/ Lic.No/Date:0910062841 06.11.2015 Defer Date:14.06.2016 258

Case No.:55/19/82-

ALC4/2015 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01536/AM16/ RLA File :03/94/040/00600/AM16/ Lic.No/Date:0310800148 09.11.2015 Defer Date:14.06.2016 259

Case No.:23/21/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01728/AM16/ RLA File :09/24/040/00481/AM16/ Lic.No/Date:0910062849 10.11.2015 Defer Date:14.06.2016 260

Case No.:165/13/82-

ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01128/AM16/ RLA File :52/24/040/00050/AM16/ Lic.No/Date:5210041688 12.11.2015 Defer Date:14.06.2016 261

Case No.:71/19/82-

ALC4/2015 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01552/AM16/ RLA File :03/94/040/00613/AM16/ Lic.No/Date:0310800272 17.11.2015 Defer Date:14.06.2016 262

Case No.:72/19/82-

ALC4/2015 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01553/AM16/ RLA File :03/94/040/00612/AM16/ Lic.No/Date:0310800271 17.11.2015 Defer Date:14.06.2016 263

Case No.:74/19/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01555/AM16/ RLA File :03/94/040/00641/AM16/ Lic.No/Date:0310800285 17.11.2015 Defer Date:14.06.2016 264

Case No.:167/13/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred

39 HQ File :01/82/050/01130/AM16/ RLA File :09/24/040/00493/AM16/ Lic.No/Date:0910062862 19.11.2015 Defer Date:14.06.2016 265

Case No.:58/19/82-

ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01539/AM16/ RLA File :03/94/040/00572/AM16/ Lic.No/Date:0310800324 19.11.2015 Defer Date:14.06.2016 266

Case No.:77/19/82-

ALC4/2015 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01558/AM16/ RLA File :03/94/040/00653/AM16/ Lic.No/Date:0310800320 19.11.2015 Defer Date:14.06.2016 267

Case No.:75/19/82-

ALC4/2015 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01556/AM16/ RLA File :03/94/040/00450/AM16/ Lic.No/Date:0310800347 20.11.2015 Defer Date:14.06.2016 268

Case No.:60/19/82-

ALC4/2015 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01541/AM16/ RLA File :03/94/040/00661/AM16/ Lic.No/Date:0310800340 20.11.2015 Defer Date:14.06.2016 269

Case No.:11/19/82-

ALC4/2015 Party Name:SURNI LABS Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01491/AM16/ RLA File :34/24/040/00214/AM16/ Lic.No/Date:3410041688 20.11.2015 Defer Date:14.06.2016 270

Case No.:28/21/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/01733/AM16/ RLA File :09/24/040/00507/AM16/ Lic.No/Date:0910062899 24.11.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/742/2015-PI(Norms) dated 29.04.2016, uploaded 271

Case No.:20/19/82-

ALC4/2015 Party Name:VDH CHEM TECH PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred

40 HQ File :01/82/050/01500/AM16/ RLA File :05/24/040/00369/AM16/ Lic.No/Date:0510396413 24.11.2015 Defer Date:14.06.2016 Decision :Deferred. 272

Case No.:24/19/82-

ALC4/2015 Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01504/AM16/ RLA File :31/83/040/00115/AM16/ Lic.No/Date:3110065769 26.11.2015 Defer Date:14.06.2016 273

Case No.:6/19/82-

ALC4/2015 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/01486/AM16/ RLA File :04/24/040/00193/AM16/ Lic.No/Date:0410161352 27.11.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/839/2015-PI(Norms) dated 18.05.2016, uploaded 274

Case No.:59/19/82-

ALC4/2015 Party Name:EXCEL INDUSTRIES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01540/AM16/ RLA File :03/94/040/00251/AM16/ Lic.No/Date:0310800536 01.12.2015 Defer Date:14.06.2016 275

Case No.:62/19/82-

ALC4/2015 Party Name:EXCEL INDUSTRIES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01543/AM16/ RLA File :03/94/040/00252/AM16/ Lic.No/Date:0310800539 01.12.2015 Defer Date:14.06.2016 276

Case No.:61/19/82-

ALC4/2015 Party Name:K V AROCHEM PVT. LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01542/AM16/ RLA File :03/94/040/00440/AM16/ Lic.No/Date:0310800529 01.12.2015 Defer Date:14.06.2016 277

Case No.:81/19/82-

ALC4/2015 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01562/AM16/ RLA File :03/94/040/00660/AM16/ Lic.No/Date:0310800594 02.12.2015 Defer Date:14.06.2016 278 Case No.:19/19/82- ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:4/82- ALC4/2016 Status:Case Deferred

41 24.05.2016 HQ File :01/82/050/01499/AM16/ RLA File :05/23/040/00370/AM16/ Lic.No/Date:0510396479 02.12.2015 Defer Date:14.06.2016 279

Case No.:27/19/82-

ALC4/2015 Party Name:S.M. HERBALS PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/01507/AM16/ RLA File :05/24/040/00373/AM16/ Lic.No/Date:0510396496 02.12.2015 Defer Date: Decision : The committee decided to approve the case with 3.5% wastage on import item with HPLC purity NMT 95%, instead of NLT (i.e.Not Less than) 95% 280

Case No.:16/19/82-

ALC4/2015 Party Name:JUBILANT GENERICS LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01496/AM16/ RLA File :05/23/040/00362/AM16/ Lic.No/Date:0510396503 03.12.2015 Defer Date:14.06.2016 281

Case No.:17/19/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01497/AM16/ RLA File :05/23/040/00002/AM16/ Lic.No/Date:0510396500 03.12.2015 Defer Date:14.06.2016 282

Case No.:38/19/82-

ALC4/2015 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01519/AM16/ RLA File :52/24/040/00062/AM16/ Lic.No/Date:5210041707 04.12.2015 Defer Date:14.06.2016 283

Case No.:63/19/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01544/AM16/ RLA File :03/94/040/00673/AM16/ Lic.No/Date:0310800674 04.12.2015 Defer Date:14.06.2016 284

Case No.:22/21/82-

ALC4/2015 Party Name:NIFTY LABS PVT LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01727/AM16/ RLA File :09/24/040/00519/AM16/ Lic.No/Date:0910062938 07.12.2015 Defer Date:14.06.2016 285

Case No.:90/19/82-

ALC4/2015 Party Name:VENUS REMEDIES LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:2210015359 Defer

42 :01/82/050/01571/AM16/ :22/24/040/00082/AM16/ 07.12.2015 Date:14.06.2016 286

Case No.:64/4/82-

ALC4/2016 Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00127/AM17/ RLA File :03/94/040/00671/AM16/ Lic.No/Date:0310800767 08.12.2015 Defer Date:14.06.2016 287

Case No.:46/21/82-

ALC4/2015 Party Name:HETERO LABS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/01751/AM16/ RLA File :09/24/040/00537/AM16/ Lic.No/Date:0910062946 08.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/658/2015-PI(Norms) dated 12.05.2016, uploaded 288

Case No.:27/21/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01732/AM16/ RLA File :09/24/040/00482/AM16/ Lic.No/Date:0910062947 08.12.2015 Defer Date:14.06.2016 289

Case No.:43/21/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01748/AM16/ RLA File :09/24/040/00518/AM16/ Lic.No/Date:0910062943 08.12.2015 Defer Date:14.06.2016 290

Case No.:89/19/82-

ALC4/2015 Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01570/AM16/ RLA File :22/24/040/00085/AM16/ Lic.No/Date:2210015363 09.12.2015 Defer Date:14.06.2016 Decision : Deferred 291

Case No.:5/15/82-

ALC4/2015 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01316/AM16/ RLA File :34/24/040/00215/AM16/ Lic.No/Date:3410041722 10.12.2015 Defer Date:14.06.2016 Decision : Deferred 292

Case No.:40/19/82-

ALC4/2015 Party Name:JUBILANT Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred

43 HQ File :01/82/050/01521/AM16/ RLA File :05/23/040/00240/AM16/ Lic.No/Date:0510396587 10.12.2015 Defer Date:14.06.2016 293

Case No.:87/19/82-

ALC4/2015 Party Name:SAURAV CHEMICALS LTD, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01568/AM16/ RLA File :22/24/040/00087/AM16/ Lic.No/Date:2210015368 10.12.2015 Defer Date:14.06.2016 294

Case No.:88/19/82-

ALC4/2015 Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01569/AM16/ RLA File :22/24/040/00081/AM16/ Lic.No/Date:2210015365 10.12.2015 Defer Date:14.06.2016 295

Case No.:94/19/82-

ALC4/2015 Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01575/AM16/ RLA File :22/24/040/00080/AM16/ Lic.No/Date:2210015366 10.12.2015 Defer Date:14.06.2016 296

Case No.:42/21/82-

ALC4/2015 Party Name:NATCO PHARMA LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01747/AM16/ RLA File :09/24/040/00520/AM16/ Lic.No/Date:0910062967 11.12.2015 Defer Date:14.06.2016 297

Case No.:50/21/82-

ALC4/2015 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01755/AM16/ RLA File :09/24/040/00490/AM16/ Lic.No/Date:0910062966 11.12.2015 Defer Date:14.06.2016 298

Case No.:43/19/82-

ALC4/2015 Party Name:U SQUARE LIFESCIENCE PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01524/AM16/ RLA File :08/24/040/00306/AM16/ Lic.No/Date:0810136712 11.12.2015 Defer Date:14.06.2016 299

Case No.:56/21/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01761/AM16/ RLA File :09/24/040/00523/AM16/ Lic.No/Date:0910062965 11.12.2015 Defer Date:14.06.2016

44 300

Case No.:30/19/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01510/AM16/ RLA File :05/24/040/00401/AM16/ Lic.No/Date:0510396611 14.12.2015 Defer Date:14.06.2016 301

Case No.:31/19/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01511/AM16/ RLA File :05/24/040/00375/AM16/ Lic.No/Date:0510396609 14.12.2015 Defer Date:14.06.2016 302

Case No.:32/19/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01513/AM16/ RLA File :05/24/040/00381/AM16/ Lic.No/Date:0510396610 14.12.2015 Defer Date:14.06.2016 303

Case No.:10/19/82-

ALC4/2015 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01490/AM16/ RLA File :34/24/040/00223/AM16/ Lic.No/Date:3410041732 14.12.2015 Defer Date:14.06.2016 304

Case No.:18/19/82-

ALC4/2015 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01498/AM16/ RLA File :52/24/040/00064/AM16/ Lic.No/Date:5210041711 15.12.2015 Defer Date:14.06.2016 305

Case No.:48/21/82-

ALC4/2015 Party Name:MYLAN Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01753/AM16/ RLA File :09/24/040/00508/AM16/ Lic.No/Date:0910062971 15.12.2015 Defer Date:14.06.2016 306

Case No.:39/19/82-

ALC4/2015 Party Name:JUBILANT Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01520/AM16/ RLA File :05/23/040/00360/AM16/ Lic.No/Date:0510396634 16.12.2015 Defer Date:14.06.2016 307 Case No.:41/19/82- ALC4/2015 Party Name:JUBILANT Meet No/Date:4/82- ALC4/2016 Status:Case Deferred

45 24.05.2016 HQ File :01/82/050/01522/AM16/ RLA File :05/23/040/00001/AM16/ Lic.No/Date:0510396632 16.12.2015 Defer Date:14.06.2016 308

Case No.:42/19/82-

ALC4/2015 Party Name:JUBILANT Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01523/AM16/ RLA File :05/23/040/00192/AM16/ Lic.No/Date:0510396633 16.12.2015 Defer Date:14.06.2016 309

Case No.:6/15/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01317/AM16/ RLA File :09/24/040/00540/AM16/ Lic.No/Date:0910062982 17.12.2015 Defer Date:14.06.2016 310

Case No.:7/15/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01318/AM16/ RLA File :09/24/040/00531/AM16/ Lic.No/Date:0910062983 17.12.2015 Defer Date:14.06.2016 311

Case No.:8/15/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01319/AM16/ RLA File :09/24/040/00536/AM16/ Lic.No/Date:0910062985 17.12.2015 Defer Date:14.06.2016 312

Case No.:9/15/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01320/AM16/ RLA File :09/24/040/00530/AM16/ Lic.No/Date:0910062986 17.12.2015 Defer Date:14.06.2016 313

Case No.:45/21/82-

ALC4/2015 Party Name:MYLAN Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01750/AM16/ RLA File :09/24/040/00392/AM16/ Lic.No/Date:0910062991 17.12.2015 Defer Date:14.06.2016 314

Case No.:36/19/82-

ALC4/2015 Party Name:PANACEA BIOTEC LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01517/AM16/ RLA File :05/24/040/00439/AM16/ Lic.No/Date:0510396670 18.12.2015 Defer Date:14.06.2016

46 Decision : Information has been called for from the firm by NC in its meeting No.02/Am17 and reply is awaited. The Committee accordingly deferred the case. 315

Case No.:90/4/82-

ALC4/2016 Party Name:BRUNDAVAN LABORATORIES PRIVATE LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00153/AM17/ RLA File :09/24/040/00556/AM16/ Lic.No/Date:0910063002 21.12.2015 Defer Date:14.06.2016 316

Case No.:35/19/82-

ALC4/2015 Party Name:HELLO PAINTS (P) LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01516/AM16/ RLA File :05/23/040/00396/AM16/ Lic.No/Date:0510396751 21.12.2015 Defer Date:14.06.2016 317

Case No.:37/19/82-

ALC4/2015 Party Name:JUBILANT GENERICS LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01518/AM16/ RLA File :05/23/040/00388/AM16/ Lic.No/Date:0510396753 21.12.2015 Defer Date:14.06.2016 318

Case No.:33/19/82-

ALC4/2015 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01514/AM16/ RLA File :05/24/040/00448/AM16/ Lic.No/Date:0510396777 21.12.2015 Defer Date:14.06.2016 319

Case No.:54/21/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01759/AM16/ RLA File :09/24/040/00525/AM16/ Lic.No/Date:0910063015 21.12.2015 Defer Date:14.06.2016 320

Case No.:61/21/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01766/AM16/ RLA File :09/24/040/00547/AM16/ Lic.No/Date:0910063018 21.12.2015 Defer Date:14.06.2016 321

Case No.:93/19/82-

ALC4/2015 Party Name:CURETECH SKINCARE Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01574/AM16/ RLA File :22/24/040/00051/AM16/ Lic.No/Date:2210015392 23.12.2015 Defer Date:14.06.2016

47 322

Case No.:132/16/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01452/AM16/ RLA File :09/24/040/00563/AM16/ Lic.No/Date:0910063042 28.12.2015 Defer Date:14.06.2016 323

Case No.:55/21/82-

ALC4/2015 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01760/AM16/ RLA File :09/24/040/00573/AM16/ Lic.No/Date:0910063035 28.12.2015 Defer Date:14.06.2016 324

Case No.:21/19/82-

ALC4/2015 Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01501/AM16/ RLA File :05/23/040/00391/AM16/ Lic.No/Date:0510397095 29.12.2015 Defer Date:14.06.2016 325

Case No.:34/21/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01739/AM16/ RLA File :31/83/040/00128/AM16/ Lic.No/Date:3110065816 30.12.2015 Defer Date:14.06.2016 326

Case No.:32/21/82-

ALC4/2015 Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01737/AM16/ RLA File :31/83/040/00135/AM16/ Lic.No/Date:3110065815 30.12.2015 Defer Date:14.06.2016 327

Case No.:22/19/82-

ALC4/2015 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01502/AM16/ RLA File :05/23/040/00244/AM16/ Lic.No/Date:0510397137 30.12.2015 Defer Date:14.06.2016 328

Case No.:23/19/82-

ALC4/2015 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01503/AM16/ RLA File :05/23/040/00260/AM16/ Lic.No/Date:0510397138 30.12.2015 Defer Date:14.06.2016 329

Case No.:13/19/82-

ALC4/2015 Party Name:MALLADI DRUGS & PHARMACEUTICALS Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred

48 LIMITED HQ File :01/82/050/01493/AM16/ RLA File :04/24/040/00213/AM16/ Lic.No/Date:0410161479 30.12.2015 Defer Date:14.06.2016 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/839/2015-PI(Norms) dated 18.05.2016, uploaded at the end of these minutes and deferred the case. 330

Case No.:40/21/82-

ALC4/2015 Party Name:MYLAN Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01745/AM16/ RLA File :09/24/040/00559/AM16/ Lic.No/Date:0910063056 30.12.2015 Defer Date:14.06.2016 331

Case No.:49/21/82-

ALC4/2015 Party Name:MYLAN Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01754/AM16/ RLA File :09/24/040/00560/AM16/ Lic.No/Date:0910063055 30.12.2015 Defer Date:14.06.2016 332

Case No.:47/21/82-

ALC4/2015 Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01752/AM16/ RLA File :09/24/040/00570/AM16/ Lic.No/Date:0910063087 01.01.2016 Defer Date:14.06.2016 333

Case No.:35/21/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01740/AM16/ RLA File :31/83/040/00094/AM16/ Lic.No/Date:3110065843 01.01.2016 Defer Date:14.06.2016 Decision : Deferred . 334

Case No.:33/21/82-

ALC4/2015 Party Name:BALAJI AMINES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01738/AM16/ RLA File :31/83/040/00117/AM16/ Lic.No/Date:3110065848 05.01.2016 Defer Date:14.06.2016 335

Case No.:137/16/82-

ALC4/2015 Party Name:DEEPAK NITRITE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01457/AM16/ RLA File :34/24/040/00245/AM16/ Lic.No/Date:3410041783 05.01.2016 Defer Date:14.06.2016 336

Case No.:68/21/82-

ALC4/2015 Party Name:CADILA HEALTHCARE LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred

49 HQ File :01/82/050/01773/AM16/ RLA File :08/24/040/00350/AM16/ Lic.No/Date:0810136965 06.01.2016 Defer Date:14.06.2016 337

Case No.:2/17/82-

ALC4/2015 Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01462/AM16/ RLA File :09/24/040/00571/AM16/ Lic.No/Date:0910063114 08.01.2016 Defer Date:14.06.2016 338

Case No.:1/17/82-

ALC4/2015 Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01461/AM16/ RLA File :09/24/040/00565/AM16/ Lic.No/Date:0910063113 08.01.2016 Defer Date:14.06.2016 339

Case No.:44/21/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01749/AM16/ RLA File :09/24/040/00588/AM16/ Lic.No/Date:0910063107 08.01.2016 Defer Date:14.06.2016 340

Case No.:4/17/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01464/AM16/ RLA File :09/24/040/00598/AM16/ Lic.No/Date:0910063124 11.01.2016 Defer Date:14.06.2016 341

Case No.:5/17/82-

ALC4/2015 Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01465/AM16/ RLA File :30/24/040/00035/AM16/ Lic.No/Date:3010103695 11.01.2016 Defer Date:14.06.2016 342

Case No.:52/21/82-

ALC4/2015 Party Name:METROCHEM API PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/01757/AM16/ RLA File :09/24/040/00612/AM16/ Lic.No/Date:0910063118 11.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/557/2015-PI(Norms) dated 12.04.2016, uploaded 343

Case No.:58/21/82-

ALC4/2015 Party Name:METROCHEM API PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved

50 HQ File :01/82/050/01763/AM16/ RLA File :09/24/040/00613/AM16/ Lic.No/Date:0910063119 11.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/557/2015-PI(Norms) dated 12.04.2016, uploaded 344

Case No.:33/2/82-

ALC4/2016 Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00033/AM17/ RLA File :03/95/040/00737/AM16/ Lic.No/Date:0310801688 11.01.2016 Defer Date:14.06.2016 345

Case No.:6/21/82-

ALC4/2015 Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01711/AM16/ RLA File :09/24/040/00602/AM16/ Lic.No/Date:0910063139 13.01.2016 Defer Date:14.06.2016 346

Case No.:60/21/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01765/AM16/ RLA File :09/24/040/00581/AM16/ Lic.No/Date:0910063135 13.01.2016 Defer Date:14.06.2016 347

Case No.:37/2/82-

ALC4/2016 Party Name:ALKALOIDS CORPORATION Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00037/AM17/ RLA File :02/24/040/00181/AM16/ Lic.No/Date:0210206452 19.01.2016 Defer Date:14.06.2016 348

Case No.:36/21/82-

ALC4/2015 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01741/AM16/ RLA File :13/24/040/00038/AM16/ Lic.No/Date:1310048100 20.01.2016 Defer Date:14.06.2016 349

Case No.:4/21/82-

ALC4/2015 Party Name:SHREE BANKEY BEHARI LAL AROMATICS Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01709/AM16/ RLA File :05/24/040/00521/AM16/ Lic.No/Date:0510397403 22.01.2016 Defer Date:14.06.2016 350

Case No.:31/21/82-

ALC4/2015 Party Name:BALAJI AMINES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred

51 HQ File :01/82/050/01736/AM16/ RLA File :31/83/040/00148/AM16/ Lic.No/Date:3110065887 25.01.2016 Defer Date:14.06.2016 351

Case No.:24/21/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01729/AM16/ RLA File :34/24/040/00267/AM16/ Lic.No/Date:3410041832 28.01.2016 Defer Date:14.06.2016 352

Case No.:88/4/82-

ALC4/2016 Party Name:VAYA JAYANTHI DRUGS(P) LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00151/AM17/ RLA File :09/24/040/00630/AM16/ Lic.No/Date:0910063185 29.01.2016 Defer Date:14.06.2016 353

Case No.:8/21/82-

ALC4/2015 Party Name:JUBILANT GENERICS LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01713/AM16/ RLA File :05/23/040/00438/AM16/ Lic.No/Date:0510397455 01.02.2016 Defer Date:14.06.2016 354

Case No.:39/21/82-

ALC4/2015 Party Name:VISCUS OILS PVT. LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01744/AM16/ RLA File :56/24/040/00042/AM16/ Lic.No/Date:5610004823 01.02.2016 Defer Date:14.06.2016 355

Case No.:19/21/82-

ALC4/2015 Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01724/AM16/ RLA File :31/83/040/00153/AM16/ Lic.No/Date:3110065906 03.02.2016 Defer Date:14.06.2016 356

Case No.:13/21/82-

ALC4/2015 Party Name:JUBILANT Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01718/AM16/ RLA File :05/23/040/00439/AM16/ Lic.No/Date:0510397481 03.02.2016 Defer Date:14.06.2016 357

Case No.:1/19/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01481/AM16/ RLA File :09/24/040/00634/AM16/ Lic.No/Date:0910063213 04.02.2016 Defer Date:14.06.2016 Decision :

52 358

Case No.:12/21/82-

ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01717/AM16/ RLA File :05/24/040/00543/AM16/ Lic.No/Date:0510397506 04.02.2016 Defer Date:14.06.2016 Decision : 359

Case No.:4/19/82-

ALC4/2015 Party Name:ALPHAMED FORMULATIONS P LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01484/AM16/ RLA File :09/24/040/00628/AM16/ Lic.No/Date:0910063226 05.02.2016 Defer Date:14.06.2016 360

Case No.:25/21/82-

ALC4/2015 Party Name:RONAK CHEMICALS Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01730/AM16/ RLA File :34/24/040/00274/AM16/ Lic.No/Date:3410041858 05.02.2016 Defer Date:14.06.2016 361

Case No.:26/21/82-

ALC4/2015 Party Name:RONAK CHEMICALS Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01731/AM16/ RLA File :34/24/040/00273/AM16/ Lic.No/Date:3410041857 05.02.2016 Defer Date:14.06.2016 362

Case No.:14/21/82-

ALC4/2015 Party Name:DHAMPUR SUGAR MILLS LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01719/AM16/ RLA File :05/23/040/00456/AM16/ Lic.No/Date:0510397521 08.02.2016 Defer Date:14.06.2016 363

Case No.:5/19/82-

ALC4/2015 Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01485/AM16/ RLA File :08/24/040/00291/AM16/ Lic.No/Date:0810137155 08.02.2016 Defer Date:14.06.2016 Decision : Deferred . 364

Case No.:62/4/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00125/AM17/ RLA File :03/95/040/00568/AM16/ Lic.No/Date:0310802284 08.02.2016 Defer Date:14.06.2016 365 Case No.:11/21/82- ALC4/2015 Party Name:SUN PHARMACEUTICAL Meet No/Date:4/82- ALC4/2016 Status:Case Deferred

53 INDUSTRIES LTD., 24.05.2016 HQ File :01/82/050/01716/AM16/ RLA File :05/24/040/00534/AM16/ Lic.No/Date:0510397525 08.02.2016 Defer Date:14.06.2016 366

Case No.:85/19/82-

ALC4/2015 Party Name:ANUPAM RASAYAN (INDIA) LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01566/AM16/ RLA File :52/24/040/00076/AM16/ Lic.No/Date:5210041759 09.02.2016 Defer Date:14.06.2016 367

Case No.:84/19/82-

ALC4/2015 Party Name:HETERO LABS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01565/AM16/ RLA File :09/24/040/00654/AM16/ Lic.No/Date:0910063231 09.02.2016 Defer Date:14.06.2016 368

Case No.:95/19/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01576/AM16/ RLA File :09/24/040/00639/AM16/ Lic.No/Date:0910063233 10.02.2016 Defer Date:14.06.2016 369

Case No.:96/19/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01577/AM16/ RLA File :09/24/040/00638/AM16/ Lic.No/Date:0910063234 10.02.2016 Defer Date:14.06.2016 370

Case No.:20/21/82-

ALC4/2015 Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01725/AM16/ RLA File :31/83/040/00155/AM16/ Lic.No/Date:3110065933 10.02.2016 Defer Date:14.06.2016 371

Case No.:8/2/82-ALC4/2016 Party

Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00008/AM17/ RLA File :34/24/040/00284/AM16/ Lic.No/Date:3410041870 10.02.2016 Defer Date:14.06.2016 372

Case No.:30/21/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01735/AM16/ RLA File :05/23/040/00467/AM16/ Lic.No/Date:0510397580 10.02.2016 Defer Date:14.06.2016

54 373

Case No.:34/4/82-

ALC4/2016 Party Name:ANUH PHARMA LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00097/AM17/ RLA File :03/94/040/00862/AM16/ Lic.No/Date:0310802461 11.02.2016 Defer Date:14.06.2016 374

Case No.:97/19/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01578/AM16/ RLA File :09/24/040/00652/AM16/ Lic.No/Date:0910063248 11.02.2016 Defer Date:14.06.2016 375

Case No.:36/2/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00036/AM17/ RLA File :03/95/040/00870/AM16/ Lic.No/Date:0310802475 11.02.2016 Defer Date:14.06.2016 376

Case No.:13/2/82-

ALC4/2016 Party Name:AMI LIFESCIENCES P LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00013/AM17/ RLA File :34/24/040/00289/AM16/ Lic.No/Date:3410041874 12.02.2016 Defer Date:14.06.2016 377

Case No.:35/4/82-

ALC4/2016 Party Name:INDOCO REMEDIES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00098/AM17/ RLA File :03/94/040/00952/AM16/ Lic.No/Date:0310802542 12.02.2016 Defer Date:14.06.2016 378

Case No.:101/19/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01582/AM16/ RLA File :09/24/040/00668/AM16/ Lic.No/Date:0910063275 16.02.2016 Defer Date:14.06.2016 379

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

POLYCOATS Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00005/AM17/ RLA File :34/24/040/00293/AM16/ Lic.No/Date:3410041887 16.02.2016 Defer Date:14.06.2016 380 Case No.:55/2/82- Party Name:MAHARSHI Meet No/Date:4/82- Status:Case

55 ALC4/2016 PHARMA CHEM PVT.LTD, ALC4/2016 24.05.2016 Deferred HQ File :01/82/050/00055/AM17/ RLA File :08/24/040/00392/AM16/ Lic.No/Date:0810137224 17.02.2016 Defer Date:14.06.2016 381

Case No.:35/2/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00035/AM17/ RLA File :03/95/040/00868/AM16/ Lic.No/Date:0310802660 17.02.2016 Defer Date:14.06.2016 382

Case No.:102/19/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01583/AM16/ RLA File :09/24/040/00666/AM16/ Lic.No/Date:0910063280 17.02.2016 Defer Date:14.06.2016 383

Case No.:52/2/82-

ALC4/2016 Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00052/AM17/ RLA File :05/23/040/00426/AM16/ Lic.No/Date:0510397651 18.02.2016 Defer Date:14.06.2016 384

Case No.:54/2/82-

ALC4/2016 Party Name:INDO PHYTO CHEMICALS PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00054/AM17/ RLA File :05/23/040/00487/AM16/ Lic.No/Date:0510397639 18.02.2016 Defer Date:14.06.2016 385

Case No.:20/4/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00083/AM17/ RLA File :05/23/040/00469/AM16/ Lic.No/Date:0510397644 18.02.2016 Defer Date:14.06.2016 386

Case No.:22/4/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00085/AM17/ RLA File :05/23/040/00471/AM16/ Lic.No/Date:0510397645 18.02.2016 Defer Date:14.06.2016 Decision : Deferred . 387

Case No.:23/4/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred

56 HQ File :01/82/050/00086/AM17/ RLA File :05/23/040/00470/AM16/ Lic.No/Date:0510397643 18.02.2016 Defer Date:14.06.2016 388

Case No.:34/2/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00034/AM17/ RLA File :03/95/040/00888/AM16/ Lic.No/Date:0310802715 19.02.2016 Defer Date:14.06.2016 389

Case No.:9/2/82-ALC4/2016 Party Name:DEEPAK

NITRITE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00009/AM17/ RLA File :34/24/040/00161/AM16/ Lic.No/Date:3410041915 22.02.2016 Defer Date:14.06.2016 390

Case No.:58/4/82-

ALC4/2016 Party Name:AARTI DRUGS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00121/AM17/ RLA File :03/94/040/00911/AM16/ Lic.No/Date:0310802757 23.02.2016 Defer Date:14.06.2016 391

Case No.:32/4/82-

ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Added HQ File :01/82/050/00095/AM17/ RLA File :03/94/040/00961/AM16/ Lic.No/Date:0310802807 23.02.2016 Defer Date: 392

Case No.:16/4/82-

ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00079/AM17/ RLA File :05/24/040/00570/AM16/ Lic.No/Date:0510397697 23.02.2016 Defer Date:14.06.2016 393

Case No.:17/4/82-

ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00080/AM17/ RLA File :05/24/040/00571/AM16/ Lic.No/Date:0510397698 23.02.2016 Defer Date:14.06.2016 394

Case No.:33/4/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00096/AM17/ RLA File :03/94/040/00940/AM16/ Lic.No/Date:0310802838 24.02.2016 Defer Date:14.06.2016

57 395

Case No.:28/2/82-

ALC4/2016 Party Name:MAC CHEM PRODUCTS (INDIA) PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00028/AM17/ RLA File :03/95/040/00858/AM16/ Lic.No/Date:0310802836 24.02.2016 Defer Date:14.06.2016 396

Case No.:27/2/82-

ALC4/2016 Party Name:PRIVI ORGANICS LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00027/AM17/ RLA File :03/95/040/00874/AM16/ Lic.No/Date:0310802827 24.02.2016 Defer Date:14.06.2016 397

Case No.:22/2/82-

ALC4/2016 Party Name:SANJIVANI PARANTERAL LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00022/AM17/ RLA File :03/95/040/00897/AM16/ Lic.No/Date:0310802826 24.02.2016 Defer Date:14.06.2016 398

Case No.:21/4/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00084/AM17/ RLA File :05/24/040/00581/AM16/ Lic.No/Date:0510397709 24.02.2016 Defer Date:14.06.2016 399

Case No.:18/4/82-

ALC4/2016 Party Name:VDH CHEM TECH PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00081/AM17/ RLA File :05/24/040/00550/AM16/ Lic.No/Date:0510397711 24.02.2016 Defer Date:14.06.2016 400

Case No.:15/4/82-

ALC4/2016 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00078/AM17/ RLA File :05/23/040/00485/AM16/ Lic.No/Date:0510397721 25.02.2016 Defer Date:14.06.2016 401

Case No.:19/4/82-

ALC4/2016 Party Name:SHREE BANKEY BEHARI LAL AROMATICS Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00082/AM17/ RLA File :05/24/040/00582/AM16/ Lic.No/Date:0510397715 25.02.2016 Defer Date:14.06.2016 402 Case No.:53/2/82- ALC4/2016 Party Name:CADILA PHARMACEUTICALS Meet No/Date:4/82- ALC4/2016 Status:Case Deferred

58 LTD. 24.05.2016 HQ File :01/82/050/00053/AM17/ RLA File :08/24/040/00409/AM16/ Lic.No/Date:0810137314 26.02.2016 Defer Date:14.06.2016 403

Case No.:24/4/82-

ALC4/2016 Party Name:JUBILANT Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00087/AM17/ RLA File :05/23/040/00491/AM16/ Lic.No/Date:0510397731 26.02.2016 Defer Date:14.06.2016 404

Case No.:4/2/82-ALC4/2016 Party Name:RIDDHI

PHARMA Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00004/AM17/ RLA File :34/24/040/00301/AM16/ Lic.No/Date:3410041924 26.02.2016 Defer Date:14.06.2016 405

Case No.:84/4/82-

ALC4/2016 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00147/AM17/ RLA File :09/24/040/00648/AM16/ Lic.No/Date:0910063326 26.02.2016 Defer Date:14.06.2016 406

Case No.:43/2/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00043/AM17/ RLA File :03/95/040/00948/AM16/ Lic.No/Date:0310802906 29.02.2016 Defer Date:14.06.2016 407

Case No.:6/2/82-ALC4/2016 Party Name:BEST VALUE

CHEM PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00006/AM17/ RLA File :34/24/040/00308/AM16/ Lic.No/Date:3410041932 01.03.2016 Defer Date:14.06.2016 408

Case No.:42/4/82-

ALC4/2016 Party Name:FINE ORGANIC INDUSTRIES PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00105/AM17/ RLA File :03/94/040/01001/AM16/ Lic.No/Date:0310802950 01.03.2016 Defer Date:14.06.2016 409

Case No.:42/2/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00042/AM17/ RLA File :03/95/040/00939/AM16/ Lic.No/Date:0310802934 01.03.2016 Defer Date:14.06.2016

59 410

Case No.:14/2/82-

ALC4/2016 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00014/AM17/ RLA File :34/24/040/00221/AM16/ Lic.No/Date:3410041935 01.03.2016 Defer Date:14.06.2016 411

Case No.:38/2/82-

ALC4/2016 Party Name:WANBURY LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00038/AM17/ RLA File :03/95/040/00920/AM16/ Lic.No/Date:0310802986 02.03.2016 Defer Date:14.06.2016 412

Case No.:28/4/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00091/AM17/ RLA File :03/94/040/00959/AM16/ Lic.No/Date:0310803032 03.03.2016 Defer Date:14.06.2016 413

Case No.:31/4/82-

ALC4/2016 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/00094/AM17/ RLA File :03/94/040/01021/AM16/ Lic.No/Date:0310803037 03.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/739/2015-PI(Norms) dated 26.04.2016, uploaded 414

Case No.:29/4/82-

ALC4/2016 Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00092/AM17/ RLA File :03/94/040/01004/AM16/ Lic.No/Date:0310803038 03.03.2016 Defer Date:14.06.2016 415

Case No.:1/21/82-

ALC4/2015 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01706/AM16/ RLA File :09/24/040/00702/AM16/ Lic.No/Date:0910063354 03.03.2016 Defer Date:14.06.2016 416

Case No.:30/4/82-

ALC4/2016 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00093/AM17/ RLA File :03/94/040/01022/AM16/ Lic.No/Date:0310803061 04.03.2016 Defer Date:14.06.2016

60 417

Case No.:3/4/82-ALC4/2016 Party Name:JAGSONPAL

PHARMACEUTICALS LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00066/AM17/ RLA File :05/23/040/00502/AM16/ Lic.No/Date:0510397820 04.03.2016 Defer Date:14.06.2016 418

Case No.:50/2/82-

ALC4/2016 Party Name:PANERA BIOTEC PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00050/AM17/ RLA File :05/24/040/00597/AM16/ Lic.No/Date:0510397827 04.03.2016 Defer Date:14.06.2016 Decision : Deferred for want of comments from DBT 419

Case No.:66/4/82-

ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00129/AM17/ RLA File :04/24/040/00257/AM16/ Lic.No/Date:0410161685 04.03.2016 Defer Date:14.06.2016 420

Case No.:67/4/82-

ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00130/AM17/ RLA File :04/24/040/00256/AM16/ Lic.No/Date:0410161684 04.03.2016 Defer Date:14.06.2016 421

Case No.:68/4/82-

ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00131/AM17/ RLA File :04/24/040/00255/AM16/ Lic.No/Date:0410161683 04.03.2016 Defer Date:14.06.2016 422

Case No.:40/4/82-

ALC4/2016 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00103/AM17/ RLA File :03/94/040/01017/AM16/ Lic.No/Date:0310803105 07.03.2016 Defer Date:14.06.2016 423

Case No.:41/4/82-

ALC4/2016 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00104/AM17/ RLA File :03/94/040/01018/AM16/ Lic.No/Date:0310803103 07.03.2016 Defer Date:14.06.2016 424 Case No.:57/4/82- Party Name:CLARIANT Meet No/Date:4/82- Status:Case

61 ALC4/2016 INDIA LIMITED ALC4/2016 24.05.2016 Deferred HQ File :01/82/050/00120/AM17/ RLA File :03/94/040/01041/AM16/ Lic.No/Date:0310803137 08.03.2016 Defer Date:14.06.2016 425

Case No.:26/2/82-

ALC4/2016 Party Name:MANGALAM DRUGS & ORGANICS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00026/AM17/ RLA File :03/95/040/00672/AM16/ Lic.No/Date:0310803128 08.03.2016 Defer Date:14.06.2016 426

Case No.:23/2/82-

ALC4/2016 Party Name:MERCK LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00023/AM17/ RLA File :03/95/040/00936/AM16/ Lic.No/Date:0310803135 08.03.2016 Defer Date:14.06.2016 427

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

SPECIALTY CHEMICALS INDIA PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00007/AM17/ RLA File :34/24/040/00323/AM16/ Lic.No/Date:3410041954 08.03.2016 Defer Date:14.06.2016 428

Case No.:56/4/82-

ALC4/2016 Party Name:CLARIANT INDIA LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00119/AM17/ RLA File :03/94/040/01040/AM16/ Lic.No/Date:0310803170 09.03.2016 Defer Date:14.06.2016 429

Case No.:55/4/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00118/AM17/ RLA File :03/94/040/01044/AM16/ Lic.No/Date:0310803171 09.03.2016 Defer Date:14.06.2016 430

Case No.:30/2/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00030/AM17/ RLA File :03/95/040/00940/AM16/ Lic.No/Date:0310803176 09.03.2016 Defer Date:14.06.2016 431

Case No.:31/2/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:0310803177 Defer

62 :01/82/050/00031/AM17/ :03/95/040/00931/AM16/ 09.03.2016 Date:14.06.2016 432

Case No.:3/2/82-ALC4/2016 Party Name:RONAK

CHEMICALS Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00003/AM17/ RLA File :34/24/040/00329/AM16/ Lic.No/Date:3410041957 09.03.2016 Defer Date:14.06.2016 433

Case No.:29/2/82-

ALC4/2016 Party Name:RUSAN PHARMA LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00029/AM17/ RLA File :03/95/040/00924/AM16/ Lic.No/Date:0310803186 09.03.2016 Defer Date:14.06.2016 434

Case No.:39/4/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00102/AM17/ RLA File :03/94/040/00973/AM16/ Lic.No/Date:0310803223 10.03.2016 Defer Date:14.06.2016 435

Case No.:58/2/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00058/AM17/ RLA File :22/24/040/00115/AM16/ Lic.No/Date:2210015444 11.03.2016 Defer Date:14.06.2016 436

Case No.:59/2/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00059/AM17/ RLA File :22/24/040/00112/AM16/ Lic.No/Date:2210015443 11.03.2016 Defer Date:14.06.2016 437

Case No.:25/2/82-

ALC4/2016 Party Name:PREGNA INTERNATIONAL LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00025/AM17/ RLA File :03/95/040/00953/AM16/ Lic.No/Date:0310803237 11.03.2016 Defer Date:14.06.2016 438

Case No.:24/2/82-

ALC4/2016 Party Name:SCOPE CHEMICALS PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00024/AM17/ RLA File :03/95/040/00955/AM16/ Lic.No/Date:0310803229 11.03.2016 Defer Date:14.06.2016

63 439

Case No.:38/4/82-

ALC4/2016 Party Name:AIMS IMPEX PVT. LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00101/AM17/ RLA File :03/94/040/01049/AM16/ Lic.No/Date:0310803267 14.03.2016 Defer Date:14.06.2016 440

Case No.:25/4/82-

ALC4/2016 Party Name:ENVEE DRUGS PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00088/AM17/ RLA File :34/24/040/00334/AM16/ Lic.No/Date:3410041974 14.03.2016 Defer Date:14.06.2016 441

Case No.:27/4/82-

ALC4/2016 Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00090/AM17/ RLA File :03/94/040/00981/AM16/ Lic.No/Date:0310803290 14.03.2016 Defer Date:14.06.2016 442

Case No.:82/4/82-

ALC4/2016 Party Name:SUNSHIELD CHEMICALS LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00145/AM17/ RLA File :03/95/040/00967/AM16/ Lic.No/Date:0310803283 14.03.2016 Defer Date:14.06.2016 443

Case No.:51/2/82-

ALC4/2016 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00051/AM17/ RLA File :08/24/040/00440/AM16/ Lic.No/Date:0810137433 15.03.2016 Defer Date:14.06.2016 444

Case No.:37/4/82-

ALC4/2016 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00100/AM17/ RLA File :03/94/040/00962/AM16/ Lic.No/Date:0310803341 15.03.2016 Defer Date:14.06.2016 445

Case No.:26/4/82-

ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00089/AM17/ RLA File :03/94/040/01057/AM16/ Lic.No/Date:0310803376 16.03.2016 Defer Date:14.06.2016 446 Case No.:7/4/82-ALC4/2016 Party Name:JUBILANT Meet No/Date:4/82- ALC4/2016 Status:Case Deferred

64 24.05.2016 HQ File :01/82/050/00070/AM17/ RLA File :05/23/040/00468/AM16/ Lic.No/Date:0510397952 17.03.2016 Defer Date:14.06.2016 447

Case No.:13/4/82-

ALC4/2016 Party Name:JUBILANT Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00076/AM17/ RLA File :05/23/040/00390/AM16/ Lic.No/Date:0510397953 17.03.2016 Defer Date:14.06.2016 448

Case No.:12/4/82-

ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00075/AM17/ RLA File :05/24/040/00613/AM16/ Lic.No/Date:0510397962 17.03.2016 Defer Date:14.06.2016 449

Case No.:9/4/82-ALC4/2016 Party Name:SUN

PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00072/AM17/ RLA File :05/24/040/00603/AM16/ Lic.No/Date:0510397956 17.03.2016 Defer Date:14.06.2016 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/781/2015-PI(Norms) dated 26.04.2016, uploaded at the end of these minutes and deferred the case. 450

Case No.:10/4/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00073/AM17/ RLA File :05/24/040/00554/AM16/ Lic.No/Date:0510397955 17.03.2016 Defer Date:14.06.2016 451

Case No.:54/4/82-

ALC4/2016 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/00117/AM17/ RLA File :03/94/040/01090/AM16/ Lic.No/Date:0310803438 18.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/739/2015-PI(Norms) dated 23.02.2016, uploaded 452

Case No.:14/4/82-

ALC4/2016 Party Name:INDO PHYTO CHEMICALS PVT LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00077/AM17/ RLA File :05/23/040/00526/AM16/ Lic.No/Date:0510397978 18.03.2016 Defer Date:14.06.2016

65 453

Case No.:52/4/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00115/AM17/ RLA File :03/94/040/01085/AM16/ Lic.No/Date:0310803441 18.03.2016 Defer Date:14.06.2016 454

Case No.:5/4/82-ALC4/2016 Party Name:JODAS

EXPOIM PVT.LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00068/AM17/ RLA File :05/23/040/00544/AM16/ Lic.No/Date:0510397982 18.03.2016 Defer Date:14.06.2016 455

Case No.:8/4/82-ALC4/2016 Party Name:JODAS

EXPOIM PVT.LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00071/AM17/ RLA File :05/23/040/00541/AM16/ Lic.No/Date:0510397985 18.03.2016 Defer Date:14.06.2016 456

Case No.:85/4/82-

ALC4/2016 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00148/AM17/ RLA File :09/24/040/00742/AM16/ Lic.No/Date:0910063432 18.03.2016 Defer Date:14.06.2016 457

Case No.:46/2/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00046/AM17/ RLA File :08/24/040/00431/AM16/ Lic.No/Date:0810137474 21.03.2016 Defer Date:14.06.2016 458

Case No.:48/2/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00048/AM17/ RLA File :08/24/040/00430/AM16/ Lic.No/Date:0810137473 21.03.2016 Defer Date:14.06.2016 459

Case No.:36/4/82-

ALC4/2016 Party Name:INDOFIL INDUSTRIES LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00099/AM17/ RLA File :03/94/040/01056/AM16/ Lic.No/Date:0310803468 21.03.2016 Defer Date:14.06.2016 460

Case No.:51/4/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred

66 LIMITED HQ File :01/82/050/00114/AM17/ RLA File :03/94/040/01086/AM16/ Lic.No/Date:0310803470 21.03.2016 Defer Date:14.06.2016 461

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

EXPOIM PVT.LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00067/AM17/ RLA File :05/23/040/00543/AM16/ Lic.No/Date:0510397989 21.03.2016 Defer Date:14.06.2016 462

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

EXPOIM PVT.LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00069/AM17/ RLA File :05/23/040/00542/AM16/ Lic.No/Date:0510397988 21.03.2016 Defer Date:14.06.2016 463

Case No.:11/4/82-

ALC4/2016 Party Name:OTSUKA CHEMICAL INDIA PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00074/AM17/ RLA File :05/24/040/00612/AM16/ Lic.No/Date:0510397994 21.03.2016 Defer Date:14.06.2016 464

Case No.:53/4/82-

ALC4/2016 Party Name:ANUH PHARMA LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00116/AM17/ RLA File :03/94/040/01066/AM16/ Lic.No/Date:0310803494 22.03.2016 Defer Date:14.06.2016 465

Case No.:47/2/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00047/AM17/ RLA File :08/24/040/00444/AM16/ Lic.No/Date:0810137475 22.03.2016 Defer Date:14.06.2016 466

Case No.:81/4/82-

ALC4/2016 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00144/AM17/ RLA File :03/95/040/00984/AM16/ Lic.No/Date:0310803500 22.03.2016 Defer Date:14.06.2016 467

Case No.:48/4/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00111/AM17/ RLA File :03/94/040/01067/AM16/ Lic.No/Date:0310803525 23.03.2016 Defer Date:14.06.2016

67 468

Case No.:49/4/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00112/AM17/ RLA File :03/94/040/01046/AM16/ Lic.No/Date:0310803524 23.03.2016 Defer Date:14.06.2016 469

Case No.:50/4/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00113/AM17/ RLA File :03/94/040/01070/AM16/ Lic.No/Date:0310803526 23.03.2016 Defer Date:14.06.2016 470

Case No.:63/4/82-

ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00126/AM17/ RLA File :03/94/040/01037/AM16/ Lic.No/Date:0310803569 28.03.2016 Defer Date:14.06.2016 471

Case No.:47/4/82-

ALC4/2016 Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00110/AM17/ RLA File :03/94/040/01078/AM16/ Lic.No/Date:0310803568 28.03.2016 Defer Date:14.06.2016 472

Case No.:60/2/82-

ALC4/2016 PHARMA LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01863/AM16/ RLA File :09/24/040/00710/AM16/ Lic.No/Date:0910063454 29.03.2016 Defer Date:14.06.2016 473

Case No.:46/4/82-

ALC4/2016 Party Name:AVIGNON EXIM PVT.LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00109/AM17/ RLA File :03/94/040/01109/AM16/ Lic.No/Date:0310803597 29.03.2016 Defer Date:14.06.2016 474

Case No.:45/4/82-

ALC4/2016 Party Name:IPCA Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/00108/AM17/ RLA File :03/94/040/01115/AM16/ Lic.No/Date:0310803599 29.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/632/2015-PI(Norms) dated 19.02.2016, uploaded

68 475

Case No.:80/4/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00143/AM17/ RLA File :03/95/040/01007/AM16/ Lic.No/Date:0310803591 29.03.2016 Defer Date:14.06.2016 476

Case No.:63/2/82-

ALC4/2016 Party Name:HETERO DRUGS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/01866/AM16/ RLA File :09/24/040/00769/AM16/ Lic.No/Date:0910063463 30.03.2016 Defer Date:14.06.2016 477

Case No.:75/4/82-

ALC4/2016 Party Name:UNIMAX LABORATORIES PVT.LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/00138/AM17/ RLA File :03/95/040/00992/AM16/ Lic.No/Date:0310803643 30.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/836/2015-PI(Norms) dated 28.04.2016, uploaded 478

Case No.:43/4/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00106/AM17/ RLA File :03/94/040/01108/AM16/ Lic.No/Date:0310803663 31.03.2016 Defer Date:14.06.2016 479

Case No.:69/4/82-

ALC4/2016 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00132/AM17/ RLA File :04/24/040/00275/AM16/ Lic.No/Date:0410161762 31.03.2016 Defer Date:14.06.2016 480

Case No.:76/4/82-

ALC4/2016 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00139/AM17/ RLA File :03/95/040/01015/AM16/ Lic.No/Date:0310803674 31.03.2016 Defer Date:14.06.2016 481

Case No.:65/4/82-

ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:0410161772 Defer

69 :01/82/050/00128/AM17/ :04/24/040/00283/AM16/ 01.04.2016 Date:14.06.2016 482

Case No.:79/4/82-

ALC4/2016 Party Name:MAKSON INDUSTRIES PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00142/AM17/ RLA File :03/95/040/01000/AM16/ Lic.No/Date:0310803763 04.04.2016 Defer Date:14.06.2016 Decision : Deferred for want of comments from MSME. 483

Case No.:77/4/82-

ALC4/2016 Party Name:TITAN LABORATORIES PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00140/AM17/ RLA File :03/95/040/00001/AM17/ Lic.No/Date:0310803752 04.04.2016 Defer Date:14.06.2016 484

Case No.:92/4/82-

ALC4/2016 Party Name:SWATI MENTHOL & ALLIED CHEMICALS LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00155/AM17/ RLA File :29/24/040/00010/AM16/ Lic.No/Date:2910025244 06.04.2016 Defer Date:14.06.2016 485

Case No.:72/4/82-

ALC4/2016 Party Name:PRASOL CHEMICALS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00135/AM17/ RLA File :03/95/040/00981/AM16/ Lic.No/Date:0310803838 07.04.2016 Defer Date:14.06.2016 Decision : Deferred . 486

Case No.:83/4/82-

ALC4/2016 Party Name:PRASOL CHEMICALS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00146/AM17/ RLA File :03/95/040/00982/AM16/ Lic.No/Date:0310803855 07.04.2016 Defer Date:14.06.2016 487

Case No.:73/4/82-

ALC4/2016 Party Name:SUPRIYA LIFESCIENCE LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00136/AM17/ RLA File :03/95/040/00301/AM16/ Lic.No/Date:0310803874 11.04.2016 Defer Date:14.06.2016 488

Case No.:71/4/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00134/AM17/ RLA File :03/95/040/00020/AM17/ Lic.No/Date:0310803870 11.04.2016 Defer Date:14.06.2016

70 489

Case No.:74/4/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00137/AM17/ RLA File :03/95/040/00021/AM17/ Lic.No/Date:0310803871 11.04.2016 Defer Date:14.06.2016 490

Case No.:78/4/82-

ALC4/2016 Party Name:MAKSON INDUSTRIES PVT. LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00141/AM17/ RLA File :03/95/040/00999/AM16/ Lic.No/Date:0310803899 12.04.2016 Defer Date:14.06.2016 Decision : Deferred for want of comments from MSME. 491

Case No.:66/2/82-

ALC4/2016 Party Name:ENCEE AROMATICS PVT. LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00060/AM17/ RLA File :32/24/040/00043/AM16/ Lic.No/Date:3210077862 13.04.2016 Defer Date:14.06.2016 492

Case No.:87/4/82-

ALC4/2016 Party Name:PI INDUSTRIES LTD Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00150/AM17/ RLA File :13/24/040/00054/AM16/ Lic.No/Date:1310048210 13.04.2016 Defer Date:14.06.2016 493

Case No.:86/4/82-

ALC4/2016 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00149/AM17/ RLA File :52/24/040/00001/AM17/ Lic.No/Date:5210041862 19.04.2016 Defer Date:14.06.2016 494

Case No.:67/2/82-

ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00061/AM17/ RLA File :09/24/040/00014/AM17/ Lic.No/Date:0910063515 19.04.2016 Defer Date:14.06.2016 495

Case No.:68/2/82-

ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00062/AM17/ RLA File :09/24/040/00019/AM17/ Lic.No/Date:0910063520 19.04.2016 Defer Date:14.06.2016 496

Case No.:69/2/82-

ALC4/2016 Party Name:ALMELO PRIVATE LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred

71 HQ File :01/82/050/00063/AM17/ RLA File :09/24/040/00739/AM16/ Lic.No/Date:0910063533 21.04.2016 Defer Date:14.06.2016 497

Case No.:1/4/82-ALC4/2016 Party Name:GRANULES

INDIA LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/00064/AM17/ RLA File :09/24/040/00026/AM17/ Lic.No/Date:0910063553 26.04.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/746/2015-PI(Norms) dated 07.03.2016, uploaded 498

Case No.:2/4/82-ALC4/2016 Party Name:HETERO LABS

LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/00065/AM17/ RLA File :09/24/040/00054/AM17/ Lic.No/Date:0910063594 07.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/823/2015-PI(Norms) dated April 2016, uploaded 499

Case No.:93/4/82-

ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/00156/AM17/ RLA File :09/24/040/00059/AM17/ Lic.No/Date:0910063612 10.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/823/2015-PI(Norms) dated April 2016, uploaded 500

Case No.:95/4/82-

ALC4/2016 Party Name:AIMS IMPEX PVT. LTD., Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00158/AM17/ RLA File :03/94/040/00129/AM17/ Lic.No/Date:0310804639 12.05.2016 Defer Date:14.06.2016 501

Case No.:94/4/82-

ALC4/2016 Party Name:MYLAN Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Deferred HQ File :01/82/050/00157/AM17/ RLA File :09/24/040/00018/AM17/ Lic.No/Date:0910063620 12.05.2016 Defer Date:14.06.2016 502

Case No.:96/4/82-

ALC4/2016 Party Name:HONOUR LAB LIMITED Meet No/Date:4/82- ALC4/2016 24.05.2016 Status:Case Approved HQ File :01/82/050/00159/AM17/ RLA File :09/24/040/00779/AM16/ Lic.No/Date:0910063631 17.05.2016 Defer Date:

72 Pharmaceuticals forwarded vide O.M.No.35011/692/2015-PI(Norms) dated 26.04.2016, uploaded Manual Agenda of NC Meeting No. 4/82/2017 Scheduled to be held on 24.05.2016

Case No. B- 01

M.No.4/AM-17 Date 24.05.2016 M/s. Mangalam Drugs and Organics Ltd File No. 01/82/050/00575/AM16 RLA No 03/95/040/01037/AM15 Adv.Auth. No. 0310794511 dated 11.03.2015 Decision:The firm has stated that end use of TMOA was not elaborated with technical details. They have now furnished the justification. Representative of DoP informed that in fresh cases they are allowing TMOA on the basis of comparison with other companies. It was decided to ask the firm as to whether there are other cases of this nature.

Case No. B- 02

M.No.4/AM-17 Date 24.05.2016 M/s. Mehta API Pvt Ltd File No. 01/82/050/00303/AM14 RLA No 03/95/040/00020/AM14 Adv.Auth. No. 0310730905 dated 09.04.2013 Decision: The Committee considered this case for amendment in the description of import item as per agenda. The Committee decided to amend the description of import item to read as “Erythromycin Thiocyanate (TIOA).

Case No. B- 03

M.No.4/AM-17 Date 24.05.2016 M/s. Metropolitan Eximchem Ltd File No. 01/82/050/01085/AM14 RLA No 03/95/040/00736/AM14 Adv.Auth. No. 0310762602 dated 16.01.2015 Decision: The Committee considered this case for amendment in the description of export item as per agenda. The comments of DCPC were not received. DCPC may send their comments before the next meeting, scheduled to be after approximately 15 days, and if nothing is received from DCPC, the Committee would decide the matter on the basis of records available.

Case No. B- 04

M.No.4/AM-17 Date 24.05.2016 M/s. Prasol Chemicals Ltd File No. 01/82/050/00989/AM14 Adv.Auth. No. 0310757684 dated 12.11.2013 Adv Auth. No. 0310649496 dated 19.08.2011 Decision:The Committee considered this case for revision of norms as per agenda. The Committee decided to revise the norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/107/2011-Ch-II dated 12.01.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No. B- 05

M.No.4/AM-17 M/s. RA Chem Pharma Ltd File No. 01/82/050/00700/AM15

73 Date 24.05.2016 RLA No 09/24/040/00198/AM15 Adv.Auth. No. 0910060661 dated 14.07.2014 Decision:The Committee considered this case for ratification of norms as per agenda. The Committee decided to defer the case for want of comments from DoP.

Case No. B- 06

M.No.4/AM-17 Date 24.05.2016 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 File No. 01/82/050/00203/AM16 Adv.Auth. No. 09310785225 dated 12.06.2014 Adv.Auth. No. 09310782942 dated 26.05.2014 Adv.Auth. No. 09310782171 dated 20.05.2014 Adv.Auth. No. 09310792676 dated 08.01.2015 Decision: The Committee considered this case for revision of norms as per agenda. It was noted that if the viscosity of the item is indeed very high as stated by the applicant, the wastage involved would be more. The consumption data certified by Customs certifies the wastage to be more than 20%. The Committee decided to call for technical details of Viscosity support by technical literature, Master Batch Formula and Batch Log sheet for recent 5 batches.

^ F. No.350 1 1 1631 120'1 5-Pl (Norms) Government of lndia Ministry of Chemical & Fertilizers Department of Pharmaceuticals Udyog Bhawan, New Delhi, Dated: 12May,2016 Office Memorandum Subject. - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s Hetero Drugs Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215018021AM-15/DES- 3/939 dated the 111115 vide which application from M/s Hetero Drugs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Famciclovir. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S.No. lmport item Norms Recommended for 1kq Export 1 2-am i no-6-ch loro-pu ri ne 1.1lkg 2 Triethyl-3-bromopropane-1, 1, 1 -tricarboxylate 2 55kg 3 Dimethvl formamide 4.00kg 2 This issues with the approval of competent authority. Under Secretary to the(3overnment oflndia PH:-23071162 Directorate General of Foreign Trade, Department of Commerce, (Shri M.V. Singh, FTDO), Udyog Bhawan, New Delhi

～ぽめ F. No.350 1 1 /7751201 s-Pl (Norms) Government of lndia Dated: 2, May 2016 Office Memorandum

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

14 Case of M/s lndoco Remedies Ltd. The undersigned is directed to refer to DGFT U.O.No. 01lB2l50l1379lAM- 16|DES-311424 dated the 1111116 vide which application from M/s lndoco Remedies Ltd. was sent to this Department for fixation of norms under para: 4.7 lor lhe export of Ciprofloxacin Ophthalmic Solution 3.5m9/ml, 5ml or 2.5m1 Boftle. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol l) 2009-14:- う ４ (Ralkumar) Under Secretary to the Government ofindia PH■23071162 Depanment Of Commerce, (Shn M∨Singh,FTDO), Udyog Bhawan,New Delhi S No lmport ltem Norms Recommended 1 Ciprofloxacin Hcl 17 48mgノ5ml Bot‖e OR 8 74mg/2 5ml BotJe

F. No.350 1 1 17321201 s-Pl (Norms) Government of lndia Dated: 28 April, 2016 Office Memorandum 14 Case of M/s Posy Pharmachem Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501609/AM- 16/DES-3/731 dated lhe 718115 vide which application from M/s Posy Pharmachem Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Sodium Gitrate BP/USP. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- 2. (Rajkumar) Under Secretary to the Government of lndia PH'.- 23071162 S.No. lmport ltem Norms Recommended for 1kq Export Citttc Acid Monohvdrate 0.68kq 2 Caustic Soda Flakes/Pearls 0.421kq

F. No.350 1 1 /7661201 s-Pl (Norms) Government of lndia Dated: 26 April, 2016 Office Memorandum 14 Case of M/s Zim Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011150/AM- 16/DES-3/1284 dated the 16112115 vide which application from M/s Zim Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Azithromycin for oral suspension 200m9/5m1. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol l) 2009-14:- 2 (Rajkuma r) PH.- 23071162 S.No. lmport ltem Norms Recommended for 1 kq Export 1 Azithromycin USP 0.078kq

ヽし 翌^彰 F No 35011ノ781/2015-Pl(Norms) Government oflndia Ministry Of Chemical&Fertilizers Dated: 26 April, 20'16 Office Memorandum 14 Case of M/s Sun Pharmaceutical lndustries Ltd. The undersigned is directed to refer to DGFT U.O.No. 01lB2l50l1295lAM- 16/DES-3/1237 dated the 15112115 vide which application from M/s Sun Pharmaceutical lndustries Ltd. was sent to this Department for fixation of norms under pata:4.7 for the export of Glarithromycin Carbomer Granules 43.7 5'/.144'/o. This department has examined the matter and the following norms are furnished under

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

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

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

(Ralkumar) Under Secretary to the Government ofindia PH: 23071162 Depanment Of Commerce, (shn M∨singh,FTDO), Udyo9 Bhawan,New Delhi

F. No.3501 1 /87412015-Pl (Norms) Government of lndia Dated: 24 May, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-1a

Case of M/s Siddharth Carbochem Products Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182150115631AM- 16/DES-3/1646 dated the 2612116 vide which application from M/s Siddharth Carbochem Products Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Methyl Salicyate IP/BP/EP/USP. 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:- DGFT is advised to call following details from the firm viz:-

1. Complete technical detail as per appendix-33 showing chemical reaction, % yield on molar basis etc.
2. Whether the export product is pharma grade or Technical grade, may be specified vis-d-vis the export description given in the application.

PH:- 23071162

F. No.3501 1170412015-Pl (Norms) Government of lndia Dated: 29, April 2016 Office Memorandum 14 Case of M/s FDC Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82l50/995/AM- 16/DES-3/1 131 dated the 26111115 videwhich application from Mis FDC Ltd. was sent to this Department for fixation of norms under para: 4.7 for lhe export of Gentamicin Ear/Eye drops Sml. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- う ４ (Rajkuma r) PH- 23071162 (Shri M V. Singh, FTDO), S.No. lmport ltem Norms Recommended 1 Gentamicin Sulphate 0.0255qm/5ml pack

F. No.350'1 1/76112015-Pl (Norms) Government of lndia Dated: 5, MaY 2016 Office Memorandum

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

Case of M/s Fermenta Biotech Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182150110781AM- 16/DES-3/1 191 dated tfre gl12t15 vide which application from M/s Fermenta Biotech Ltd. was sent to this Department for fixation of norms under para: 4.7 for lhe export of Ergocalciferol oral solution usP (vitamin D2 1.O to 4.0 MIU in edible oil- solabean/corn/arachis/MCT oil). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14.- DGFT is advised to call following details from the firm viz:-

1. The firm has shown wide range of vitamin D2 in the export product. specific strength of the oral solution in terms of Vitamin D2 may be furnished'
2. Detaiied working on the norms applied may also be given' PH.- 23071162

t 0t
l1' F. No.350 1 1 17 53120'1 s-Pl (Norms) Government of lndia Dated: 5, May 2016 Office Memorandum

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

Case of M/s lnfinity Labs Pvt. Ltd. ' The undersigned is directed to refer to DGFT U.O.No. 0118215011055/AM- 16/DES-3/1363 dated the 21112115 vide which application from M/s lnfinity Labs Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Levofloxacin Hemihydrate. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14.- S.No. lmport ltem Norms Recommended for 1kq Export 1 Levofloxacin Q acid 0.8571kq 2 N-methvl piperazine 0 432kq 3 Dimethvl sulfoxide 0 2193kq 2. PH.- 23071162

F. No.3501'1 /69612015-Pl (Norms) Government of lnd ia Dated: '18 May, 2016 Off ice 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. 01/82i50/658/AM- 16/DES-3/802 dated the 14l1l15 vide which application from M/s Jodas Expoim Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Vancomycin injections 500m9/10m1 and 1gm/20m1. 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:- Note:‐ The firm has not produced DML for 500mg lniectiOn 2. (Rajk u ma r) PH- 23071162 S.No. lmport item Norms Recommended 1 Vancomvcin Hcl EP Sterile 1.077smlvial

,L F. No.3501 1/7731201 s-Pl (Norms) Government of lnd ia Dated: 26 April, 2016 Off ice 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. 011821501107214M- 16/DES-3/1 180 dated the 9112115 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 Clarithromycin Granules 43%. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- DGFT is advised to call copy of Master-Batch formula from the firm for the above export item duly Certified by their Q.C. lncharge. 2. (Rajk u ma r) PH:- 23071162

⌒ F. No.350 1 1 17841201 s-Pl (Norms) Government of lndia Dated: 29, April 2016 Office Memorandum 14 Case of M/s Venus Remedies Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011020/AM- 16/DES-3/1405 dated the 1111116 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 Cefoperazone and Sulbactam for injection 1gm/29m. This department has examined the matter and the following norms are furnished under para 4.7 o'f Hand Book of Procedures (Vol.l) 2009-14.- 2. (Rajkumar) PH'.- 23071162 S.No. lmport ltem Norms Recommended For 1qm iniection For 2qm iniection Sulbactarll Sodiurn Sterile USP 557.143mq 1115,929mg

;Yzq F. No.3501 1/75 1 12015-Pl (Norms) Government of lndia Dated: 5, May 20'16 Office Memorandum

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

Case of M/s Astec Life Sciences Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82150/1090iAM- 16/DES-3/1348 dated the 1012116 vide which application from M/s Astec Life Sciences Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Tebuconazole. 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:- As per literature, Tebuconazole is a triazole fungicide used agriculturally to treat plant pathogenic fungi. As such DoP is not concerned. Petrochemical. DGFT may refer this case to Deptt. of Chemical & つ ４ (Rajkumar) PH- 23071162

へ _

I o
z\ F. No.3501 1/75 1 12015-Pl (Norms) Government of lndia Dated: 5, MaY 2016 Office Memorandum

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

Case of M/s Astec Life Sciences Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82150/1089/AM- 16/DES-3/1372 dated the 21112115 vide which application from M/s Astec Life Sciences Ltd. was sent to this Department for fixation of norms under para: 4.7 fot the export of Dextrinol. 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:- As per literature, these dextrin's are water-soluble glues used in adhesive, food processing, textile finishing etc. As such DoP is not concerned. DGFT may refer this case to Deptt. of Chemical & Petrochem ical. 2. PH:- 23071162

ハ ^

F. No.350 1 1 177 51201 S-Pl (Norms) Government of lndia Dated: 2, May 2016 Office Memorandum Subject. - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case of M/s lndoco Remedies Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182150i1365/AM- 16/DES-3/1506 dated the 1211116 vide which application from M/s lndoco Remedies Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Azelastine Hydrochloride Ophthalmic Solution 0.05%, 6ml Bottle. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14'.- 2. (Rajkumar) PH.- 23071162 S.No. lmport ltem Norms Recommended Azelastine Hcl 3 15mq/6ml Bottle 2 Eye Drop Bottle Relevant, As per packinq policv 3 Eye Drop Cap Relevant, As per packinq policy 4 Eye Drop lnsert Relevant, As per packinq policv

（ 　 （ ■ F. No.350 11 17621201 S-Pt (Norms) Government of lndia Dated: 5, May 2016 Office Memorandum

Subject: - Fixation--oJ n9rm1 under para 4.7 of Hand Book of procedures (vol.l) 2oog-14

Case of M/s Archimedis Laboratories pvt. Ltd. The undersigned is directed to refer to DGFT U.o.No. o1ll2l5ot1101/AM- 16/DES-3/1315 dated the 16t12t15 vide which application from M/s Archimedis Laboratories Pvt' Ltd. was sent to this Department ror'rixation of norms under para. 4.7 for the export of , .2_,4_-dihydro-4-[4-t(a+ydrory pr,"nyr)-1-piperazinyr]phenyrl-2_(1- metlYf propyl)-3H-1,2,4-trizol-3-one. This deplrtment has examined the matter and ja"rJ:l;Iing norms are furnished under para '4.7 of Hand Book of procedures (Vot.t) S No lmport ltem Triethyl ortho Dimethyl form Dimethyl sulfo chloroform Norms Recommended for 1kg Export 2 1.16kg 2.67kg 3 4.44kg 4 1 75kg 5 8 lrrn are shOwn indigenous」:11も漕γconsumptiOn reportfOr 甜::l『:電:躍料施1蟹10威qu酬サ . 2. 丁his issues with the apprOval of cOmpetent authority. Under secretary to the GovemmきntЪf lndig PH:-23071162 Directorate(3enera1 0f Foreign Trade, Depattment of cOmmerce, (Shtt M.V.Singh,FttDO), Udyog Bhawan,New Delhi

〇キ⑩ F. No.3501 1174212015-Pl (Norms) Government of lndia Dated: 29, April 2016 Office Memorandum 14 Case of M/s Optimus Drugs Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182150112611AM- 16iDES-3i1288 dated the 16112115 vide which application from M/s Optimus Drugs Pvt. Ltd. was sent to this Department for fixation of norms under para:4.7 for the export of Sofosbuvir. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- 2 (Ralkumar) Under Secretary to the Covernment oflndia PH:-23071162 Depanment Of Commerce, (Sh百M V Singh,FTDO), Udyog Bhawan,New Delhi S No lmport ltem Norms Recommended for 1 kq Export 1 2-deoxy-2-f I uoro-2-C-methylu rid i ne 0 90kq う ４ N― [(S)― (2,3,4,5,6- pentafluorophenoxy)phenOxyphosphinyl]― L―alanine l―methyl ethyl ester 1 92kg

F. No.350 1 1 lB31 1201 s-Pl (Norms) Government of lndia Dated: 1B May, 2016 Office Memorandum

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

2009-14 Case of M/s Archimedis Labs Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501111s/AM- 16/DES-3/1499 dated the 1211116 vide which application from M/s Archimedis Labs Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Cis-[2-[2,4-dichlorophenyll2-t1H-1,2,4-triazole-l ylmethyl-1-3-dioxalan- 4-yll methanol.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'.- 2 Thls issues with the approval of competent authority. PH.- 23071162 S.No. lmport item 1kg Export 1 Cis bromobenzoate 2.22k9 2 1,2,A-triazole 0.61kq 3 Dimethyl sulfoxide 1.35kq 4 Potassium carbonate 0.69kq 5 Caustic soda flakes 0.40kq 6 Toluene 0.93kq

`И F. No.350 1 1 lB7 1 1201 s-Pl (Norms) Government of lndia Dated: 24 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 MSN Pharmachem Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011525/AM- 16/DES-3/1695 dated the 1912116 vide which application from M/s MSN Pharmachem Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Atorvastatin Calcium. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14'.- PH'.- 23071162 独レ 2. S.No. lmport item Norms Recommended for 1kq of export 1 (4 R-C is)- 1, 1 -d imethylethyl-6-cyanomethyl-2, 2-d imethyl- 1, 3-d ioxa ne-4-acetate 0.70Bkg 2 Methanol 6 225kq 3 Methyl isobutyryl acetate 1.423kq

F. No.350 1 1 1841 1201 5-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 lndoco Remedies Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182t50t1534iAM- 16/DES-3/1678 dated the 1912116 vide which application from M/s lndoco Remedies Ltd. was sent to this Department for fixation of norms under paru: 4.7 for the export of Allopurino! 100m9 & 300mg 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'.- Fn l-r,r rf t j\r^ ;' o, (Rajkumar) PH:- 23071162 2. S.No. lmport item For Export of 1No. Tablet 100mq 300mg 1 AIlopuΠ nol " え た。^.ヽトイ∫tO～ 102mq 306mg

CA_:ラ

F. No.350 1 1 18391201 s-Pl (Norms) Government of lndia Dated: 1B May, 2016 Office Memorandum

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

2009-14 Case of M/s Malladi Drugs & Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011486/AM- 16/DES-3/1682 dated the 1912116 vide which application from M/s Malladi Drugs & Pharma Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of N-t-BOC-Trans-4-Hydroxy-L-Proline. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 - 2. PH:-23071162 S.No. lmport item 1ks Export Tra ns-4-hvd roxv- L- P ro I i ne 0.BB6kq 2 Di― tert butvldicarbonate 1.51kq 3 Ethvl Acetate 2.635kq 4 Causticsoda flakes 0.30kq

⌒ ⌒ 、ヽ 9ン 戦 乳≫r2 F. No.350 1 1 16581201 s-Pl (Norms) Government of lndia Dated: 12May,2016 Office Memorandum

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

Case of M/s Hetero Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 01lB2l50l1751iAM- 15/DES-3/1901 dated the 30/3/16 vide which application from M/s Hetero Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of L'Valine Methyl Ester Hydrochloride. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14'.- 2 Under Secretary to the Government oflndia PH:… 23071162 S No lmport item 1kq Export 1 L―∨aline 0 77kg 2 Thionvl Chloride 0 94kg 3 Methanol 0.96kg 4 Acetone 0 96kg

t-^ 9
F No.3501 1/83912015-Pl (Norms) Government of lndia 4zq Dated: 1B May,2016 Office Memorandum

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

2009-14 Case of M/s Malladi Drugs & Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 01l92l50l14g3lAM- 16/DES-3/1680 dated the 1912116 vide which application from M/s Malladi Drugs & Pharma Ltd. was sent to this Department for fixation of norms under para: 4.7 for lhe export of (aS,5R)-(-)- -methyl-5-phenyl-2-oxazolidinone(chiral oxazolidinone). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- DGFT is advised to call following details form the firm viz:-

1. Complete technical detail as per appendix-33.
2. Past production vis-d-vis actual consumption of all imported inputs duly certified by Central Excise Authorities.

PH:- 23071162

:- ' nu1-. :- -] Government of lndia Ministry of Chernieal & Fertilizers Depafiment of Pharmaceuticals . Dated: 12 April, 201O Office Memorandum

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

Case of M/s Metrochem API Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01tB2t5Ot17S7tAM- 16/DES-3/1898 dated the 30/3i16 vide which application from M/s Metrochem API Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Esomeprazole Magnesium Pellets 8.5%. 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. PH:- 23071162 S.No. lmpofi ltem 1kq Export 1 3,5 Lutidine 0.0962kg 2 Methylene chloride 0.537kq 3 Methanol 0.694kq 4 Toluene 0.4353k9 5 Actic acid 0.1 31 ks 6 Acetone 0.1717 kq 7 Ammonium persulphate 0 099kcI 8 Hydroxy propyl methyl cellusose (HPMC-E5) 0 05839kg

０ 一 gq2 -Ministryof-ehemic a*fertiti Department of pharmaieuticals F. No.3501 1tSS7t2o15-pt (Norms) Government of lndia , Dated: 12 April,2016 Office Memorandum

subject: --Fixation 9j 19rms under para 4.7 of Hand Book of procedures (Vol.l) 2oog-14

Case of M/s Metrochem Apl pvt. Ltd. The undersigned is directed to refer to DGFT U.o.No. o1tL2lsot1763lA[- 16/DES-3/1894 dated the 3013116 vide which rppri.rt,:on from M/s Metrochem Apl pvt. Ltd' was sent to this Department for fixation ot',jorrr under para: 4.7 for the export of Esomeprazole Magnesium. This department h;; examined the matter and the l"j:*''n norms are furnished under paia 4.7 "t HrrJ Book or proceoures (Vot.t) 2009_ /) 2. llL= Under secretary to the oouu,.nrlTiti,ffi? PH:- 23071162 -(Shri M.V. Singh; FTDO);- １ １ 十 １ １ ｌ Ｌ Ｆ ■ ― ． lmport ltem 3,5 Lutidine Methylene chloride Methanol Toluene Actic acid Acetone ― m5erSulphate

ハ F. No.350 1 1 17391201 5-Pl (Norms) Government ui lndia Dated: 26 April, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2OO9-14

Case of M/s Glenmark Pharmaceuticals Ltd. The undersigned is directed to refer to DGFT U O.No. 0118215011633/AM- 16/DES-3/1819 dated the 1513/16 vide which application from M/s Glenmark pharmaceuticals Ltd. was sent to this Deparlment for fixation of norms under para'. 4.7 for the export of Mometasone Furoate 50mcg + Azelastine Hcl 140mcg,150MD. This departrnent has.examinecl ihe inatter and the followlng neilrrs are furnished undei para 4.7 of Hand Book of Procedures (Vol.l) 2009-14.- S.No. lmport ltem Norms Recommended Mometasone Furoate BP (Micronized) 7.65mq/pack つ 」 Azelastine Hcl BP 21.42mqlpack 2 PH'- 23071162

F No 35011/781/2015¨ PI(Norms) Government oflndia Ministry of Chemical&Fertilizers Department of Pharrllaceuticals く の LЧ q Dated: 26 April, 2016 Office Memorandum 14 Case of M/s Sun Pharmaceutical lndustries Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182150/1438/AM- 16/DES-3/1407 dated the 1111116 vide which application from M/s Sun Pharmaceutical lndustries Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Clarithromycin Carbomer Granules 27.5128o/o. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14'.- DGFT is advised to call following details from the firm viz:-

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

(Ralkumar) Under Secretary to the(3overnment oflndia PH:-23071162

F. No.350 1 1 17391201 s-Pl (Norms) Government of lndia Ministry of Chemical & Fertilrzers Dated: 23 February, 2016 Office Memorandum 14 Case of M/s Glenmark Pharmaceuticals Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501154914M- 16/DES-3/1669 dated the 1912116 vide which application from M/s Glenmark Pharmaceuticals Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Amiodarone Hcl. This department has examined the matter and the following norms are furnished undet para 4.7 of Hand Book of Procedures (Vol.l) 2009-14- 2. (Rajkumar) S. No. lmport ltem 1kg Export И . 2-Butyl-3-(3, 5-D i iodo-4-Hyd roxybenzoyl) Benzofuran 0.9135k9 、′′′ `2と . N, N Diethy-2-Chloroethvlamine Hcl 0 315kq 3 Potassium Carbonate 0 694kq 4. lsopropvl Alcohol 2.70kq

F. No.350 1 I 16321201 s-Pl (Norms) Government of lndia Depa rtment of Pharmaceuticals Dated: 19 February,2016 Office Memorandum 14 Case of M/s IPCA Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. O1t82t5Ol1390/AM- 16/DES-3/1503 dated the 1211116 vide which application from M/s. IPCA Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Pyrantel Pamoate. This department has examined the matter and the following norms furnished under para 4.7 of Hand Book 2. (Rajkumar) are Turn ra of Procedures (Vol.l) 2009-14.- S. No. lmport ltem 1kg Export Thiophene-2-AIdehyde 0.30kq 2. Bon Acid 0.77kq 3 lsopropyl Alcohol 0 32kq 4 Citttc Acid 0.45kq 5 Acetonitrile 0 28kq

ハ ∂ F No.35011/836/2015-PI(Norms) Government oflndia Ministry of Chemical&Fertilizers Dated: 28 April, 2016 Office Memorandum 14 Case of M/s Unimax Labs Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182150/1369/AM- 16/DES-3/1473 dated the 1211113 vide which application from M/s Unimax Labs Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Dexamethasone Sodium Phosphate. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14- S No. lmport ltem Norms Recommended for 1kq Export Dexamethasone 0.78kq 2 (Ralkumar) ∪nder Secretary to the(3overnment oflndia PH:-23071162

F. No.350 1 1 17 461201 5-Pl (Norms) Government of lndia Dated: 7 March, 2016 Office Memorandum 14 Case of M/s Granules lndia Ltd. The undersigned is directed to refer to DGFT U.O.No.01 18215011283/AM- 16iDES-3/1329 dated the 18112115 vide which application from M/s Granules lndia Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of (2S,5R)-5-fluorocytosine-1-YL-[1 ,3]-oxathiolane-2-carboxylic acid menthyl ester (FCE). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- 2. (Rajkumar) PH:- 23071162 S.No. lmpoft ltem Norms Recommended for 1ko Exoort Glyoxalic acid 50% 0 68kq 2 Cvclohexane 1.227kq 3 2,5-dihydroxy- 1,4-dithiane 0.28kq 4 5-fluoro cytosine 0.50kq 5 Methylene chloride 3.671kq 6 HMDS 0.53kq

lqq Office Memorandum

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

Case of M/s Hetero Labs Ltd. The undersigned is directed to refer to DGFT U.o.No. o1ll2t5ol1451lAM- 16/DES-3/1807 dated the 15t3t16 vide which appticatLn fr; M). H"j;;; i][r'iil'. *u. ,, .t.9lJl1t!js Department for fixation of norms under para:4.7 f"; til;;p"ilt a,--#ir.- N-(2R,3S)(3-amino-2-hydroxy-4-phenyl-butyl)-N-isobutylb"n="n" sulfonamide. This department has examineb the ,ritur rnd'th. totrowinj noir. are furnished under

para 4.7 0f Hand Book of procedures (vor.r) 20og-14:-

F.N6.350117823/2015-|| Norms Deparlment of Phai-maceuiicais Udyog Bhawan, Nevu Delhi, Dated: aprtl,ZOTG 2 Under secretary to the cou"rnr$i*i,ffi? PH:-23071162 Departnrent of Commerce, Sh百M∨ . yog Bhawan, New Delhi S.No. lmport ltem 1kg Export \zo, rD/-J-(ren. Dutoxycarbonyl amino)_ 1,2_epoxy_ 4-phenyl butane 0.91k9 ＾ Ｚ tuuuuLvt amlne 0 98kq 3 IOU|JI UTJVI iIIUUIIOI Methanol 6.20k9 4 2.37ks

Office Memorandum

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

Government of lndia Udyog Bhavrran, Nevy Dellri, Dated: April, 2016 Case of M/s Hetero Labs Ltd. lmport ltem 1kg Export 1 111-([1,1-biphenyl-4,4-diyl)bis(2-bromoethane-1- one) 1.303k9 2 N-(teft-butoxy carbonyl)-L-proline 1.481kg 3 Meth oxyca rbonyl-l-va I i ne 0 771kg 4 1 -(3-d imethylaminopropyl)-3-ethyl carbod imide hydrochloride 0.60kg PH:-23071162 The undersigned is directed to refer to DGFT U.O.No. 01l82t5Ol1314lAM- 16/DES-3/1808 dated Ihe 1513116 vide which application from M/s Hetero Labs Ltd. was sent to this Department for fixation oi norms urrrder para: 4.7 for the export of Daclatasvir dihydrochloride. This depaftment has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14:- 2

• -Department of-Gommerce, Udyog Bhawan, New Dellri S.No.

F. No.350 1 I 16921201 s-Pl (Norms) Government of lndia Dated: 26 February, 2016 Office Memorandum 14 Case of M/s Honour Lab Ltd. The undersigned is directed to refer to DGFT U.O.No. 01l82l50lB14lAM- 16/DES-3i1016 dated the 27110115 vide which application from M/s Honour Lab Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Gemifloxacin Mesylate. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- 2. (Rajkumar) PH'- 23071162 (Shri M.V. Singh, FTDO), Udyog Bhawan, New Delhi S No. lmport ltem Norms Recommended for 1kq Export 3-Cyano-2,6-dichloro-S-fluoro pyridine 0 834kq 2 Dimethvl formamide 4.30ks 3. Diethvl malanate 0.98kq 4. Cyclopropyl anrine 0 261kq 5. Glycine ethyl ester hydrochloride 0.967kq 6 DI―tert butvl dicarbonate 2 408kq 7. Methoxyamine HCL 0.404kq

多 、 、 )_ 。′ ロロ 、 1.∬躙職壼為臨 i硼s subject; Advance-lTrrl',on appilcarion from M/s. prasor chomi^^r^ , - , - raw material against tne expoi ot rr,resiivit;;;i.' chemlcars Ltd. fcr thc impo;r of (Advance At (Ad,;;;;;'J,ffffiff ffiffiI8#Y3g q,t"q 1s 08 2o1 1) dt6u dated 12.1l.zots) Ret u'o No. 01/8zo5AWg1AAil-16lDES-fr/943dared9.09.2015. M/s. prasot ?IA,.:,: trd. has submftied presenr ar rnaterial against the export "i irii,rtr trr= . rplication for the import of raw iiru ay:piicaiioir has been exemiled anri iha i.ran: n'rlrnsfo;'-."is+ntecvanceartn**i;.;;;;".''::i"'t',. L--.-,,,,.t-r...rc ine fu,,...:;,; ltem赫 l ΔrET⌒、I「 Qty υ に l kg |ヽこ 2 158 kg I nts lssues wiih ine ;lpprovai or- competent authority. o1'C&PC ti.C. Na 1401o/1o7/2011_cHィl dated 12.ol.2016 ヽ ヽ 「 誘 歩 ο%|∂″↑イア_ ｀｀