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. 18/82/2016 of 2016-17 dated 15.02.2017 to consider the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products and falling under Chapter 29 and 30, scheduled to be held on 15.02.2017 but actually held on 22.02.2017 under the Chairmanship of Shri J.V. Patil, Addl. DGFT in Room No.04, Udyog Bhawan, New Delhi. Following members were present:- Shri Nirmal Kumar, Dy. Director General of Foreign Trade Shri V.K. Tyagi, Consultant, D/o Pharmaceuticals. The committee went through the minutes of earlier meeting No. 17/82 dated 24.01.2017 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 tht the items of import/export are not SCOMET items. MEETING NUMBER : 18/82-ALC4/2016 MEETING DATE : 15.02.2017 1

Case No.:15/2/82-ALC4/2016

Party Name:PERFECT INDUSTRIES PRIVATE LIMITED. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00015/AM17/ RLA File :03/95/040/00554/AM12/ Lic.No/Date:0310659678 14.10.2011 Defer Date:22.03.2017 Decision :Deferred 2

Case No.:131/16/82-

ALC4/2016 Party Name:SARNA CHEMICALS PVT.LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00948/AM17/ RLA File :52/24/040/00043/AM13/ Lic.No/Date:5210039465 14.02.2013 Defer Date:22.03.2017 Decision :Deferred 3 Case No.:173/5/82- Party Name:FORACE Meet No/Date:18/82- Status:

2 ALC4/2015 POLYMERS (P) LTD. ALC4/2016 15.02.2017 Deferred HQ File :01/82/050/00313/AM16/ RLA File :05/23/040/00069/AM14/ Lic.No/Date:0510356983 13.06.2013 Defer Date:22.03.2017 Decision :Deferred 4

Case No.:61/4/82-ALC4/2016

Party Name:ADCOCK INGRAM LTD, Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00124/AM17/ RLA File :07/24/040/00097/AM14/ Lic.No/Date:0710096460 04.07.2013 Defer Date:22.03.2017 Decision : The Committee noted that information has been called for from the firm by NC in its meeting No.12 dated 28.09.2016 is awaited. The committee accordingly decided to await the reply and deferred the case. 5

Case No.:31/4/82-ALC4/2014

Party Name:UNIVERSAL BIOFUELS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00279/AM15/ RLA File :09/24/040/00155/AM14/ Lic.No/Date:0910056959 31.07.2013 Defer Date:22.03.2017 Decision :Deferred. 6

Case No.:213/3/82-

ALC4/2014 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status:Approved HQ File :01/82/050/00217/AM15/ RLA File :34/24/040/00184/AM14/ Lic.No/Date:3410038266 21.10.2013 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.41/82 dated 10.01.2012 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 7

Case No.:48/13/82-

ALC4/2015 Party Name:BELCHEM INDS. INDIA PVT. LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01011/AM16/ RLA File :03/94/040/00860/AM14/ Lic.No/Date:0310766718 17.01.2014 Defer Date:22.03.2017 Decision :Deferred 8

Case No.:195/3/82-

ALC4/2014 Party Name:JAINEX SPECIALITY CHEMICAL Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00199/AM15/ RLA File :34/24/040/00249/AM14/ Lic.No/Date:3410039038 17.01.2014 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.03/82 dated 08.05.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take

3 9

Case No.:57/3/82-ALC4/2014

Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00061/AM15/ RLA File :05/23/040/00506/AM14/ Lic.No/Date:0510382053 18.03.2014 Defer Date:22.03.2017 Decision :Deferred. 10

Case No.:49/13/82-

ALC4/2015 Party Name:BELCHEM INDS. INDIA PVT. LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01012/AM16/ RLA File :03/94/040/01118/AM14/ Lic.No/Date:0310779215 23.04.2014 Defer Date:22.03.2017 Decision :Deferred. 11

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

Party Name:MACSON PRODUCTS Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00345/AM17/ RLA File :52/21/040/00011/AM15/ Lic.No/Date:5210041026 12.05.2014 Defer Date:22.03.2017 Decision :Deferred. 12

Case No.:38/8/82-ALC4/2014 Party Name:MYLAN

LABORATORIES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00702/AM15/ RLA File :09/24/040/00108/AM15/ Lic.No/Date:0910060258 28.05.2014 Defer Date:22.03.2017 Decision :Deferred for want of comments from DoP. 13

Case No.:165/6/82-

ALC4/2014 Party Name:HALDIA PETROCHEMICALS LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00567/AM15/ RLA File :02/24/040/00037/AM15/ Lic.No/Date:0210203844 05.06.2014 Defer Date:22.03.2017 Decision :Deferred. 1 4

Case No.:232/6/82-

ALC4/2014 Party Name:JAINEX SPECIALITY CHEMICA L Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approve d HQ File :01/82/050/00634/AM15 / RLA File :34/24/040/00079/AM15/ Lic.No/Date:341004031 7 26.06.2014 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.03/82 dated 08.05.2014 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take 15

Case No.:202/6/82-

ALC4/2014 Party Name:FORACE POLYMERS (P) LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred

4 HQ File :01/82/050/00604/AM15/ RLA File :05/23/040/00139/AM15/ Lic.No/Date:0510389232 01.07.2014 Defer Date:22.03.2017 Decision :Deferred. 16

Case No.:264/13/82-

ALC4/2014 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01267/AM15/ RLA File :03/94/040/00405/AM15/ Lic.No/Date:0310788397 26.08.2014 Defer Date:22.03.2017 Decision :Deferred. 17

Case No.:255/13/82-

ALC4/2014 Party Name:THE DHARAMSI MORARJI CHEMICAL CO LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01258/AM15/ RLA File :03/95/040/00431/AM15/ Lic.No/Date:0310788373 26.08.2014 Defer Date:22.03.2017 Decision : Deferred. 18

Case No.:263/13/82-

ALC4/2014 Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01266/AM15/ RLA File :03/94/040/00962/AM14/ Lic.No/Date:0310788558 01.09.2014 Defer Date:22.03.2017 19

Case No.:217/13/82-

ALC4/2014 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01220/AM15/ RLA File :03/94/040/00494/AM15/ Lic.No/Date:0310788620 02.09.2014 Defer Date:22.03.2017 Decision : It was noted that fraudulent CA certificates have been submitted in this case. The matter is under investigation. The Committee accordingly decided to defer the case. 20

Case No.:9/15/82-

ALC4/2014 Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status:Rejected HQ File :01/82/050/01296/AM15/ RLA File :09/24/040/00327/AM15/ Lic.No/Date:0910061001 19.09.2014 Defer Date: Decision : The Committee noted that information had been called for from the firm in NC meeting No.04/82 dated 24.05.2016 but it has not furnished so far. In absence of this information, it is not possible to ratify norms. The committee accordingly decided to reject the case. RA concerned may take further necessary action as per the decision of NC. 21

Case No.:17/13/82-

ALC4/2014 Party Name:GRASIM INDUSTRIES LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01020/AM15/ RLA File :34/24/040/00155/AM15/ Lic.No/Date:3410040570 23.09.2014 Defer Date:22.03.2017

5 Decision :Deferred. 22

Case No.:19/13/82-

ALC4/2014 Party Name:SANO MEDICAL KITS PVT. LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01022/AM15/ RLA File :04/24/040/00171/AM15/ Lic.No/Date:0410159504 29.09.2014 Defer Date:22.03.2017 Decision : Information has been received from the firm and it has been sent to DoP for comments. The Committee accordingly deferred the case for want of comments. 23

Case No.:134/13/82-

ALC4/2014 Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01137/AM15/ RLA File :52/24/040/00031/AM15/ Lic.No/Date:5210041251 07.10.2014 Defer Date:22.03.2017 Decision :Deferred. 24

Case No.:42/15/82-

ALC4/2014 Party Name:PVS AGRO VET Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01329/AM15/ RLA File :09/24/040/00246/AM15/ Lic.No/Date:0910061105 16.10.2014 Defer Date:22.03.2017 Decision : Information has been received from the firm and it has been sent to DoP for comments. The Committee accordingly deferred the case for want of comments. 25

Case No.:110/13/82-

ALC4/2014 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01113/AM15/ RLA File :34/24/040/00188/AM15/ Lic.No/Date:3410040635 22.10.2014 Defer Date:22.03.2017 Decision :Deferred. 26

Case No.:86/10/82-

ALC4/2014 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01000/AM15/ RLA File :34/24/040/00194/AM15/ Lic.No/Date:3410040644 30.10.2014 Defer Date:22.03.2017 Decision :Deferred. 27

Case No.:266/13/82-

ALC4/2014 Party Name:ATUL LIMITED, Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01269/AM15/ RLA File :08/24/040/00289/AM15/ Lic.No/Date:0810133735 05.11.2014 Defer Date:22.03.2017 28 Case No.:268/13/82- Party Name:ATUL LIMITED, Meet No/Date:18/82- Status:

6 ALC4/2014 ALC4/2016 15.02.2017 Deferred HQ File :01/82/050/01271/AM15/ RLA File :08/24/040/00283/AM15/ Lic.No/Date:0810133734 05.11.2014 Defer Date:22.03.2017 29

Case No.:107/13/82-

ALC4/2014 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01110/AM15/ RLA File :34/24/040/00196/AM15/ Lic.No/Date:3410040655 05.11.2014 Defer Date:22.03.2017 30

Case No.:111/13/82-

ALC4/2014 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01114/AM15/ RLA File :05/23/040/00352/AM15/ Lic.No/Date:0510391927 11.11.2014 Defer Date:22.03.2017 Decision : Deferred for want of comments from AYUSH. 31

Case No.:100/4/82-

ALC4/2015 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00139/AM16/ RLA File :17/24/040/00125/AM15/ Lic.No/Date:1710005978 12.11.2014 Defer Date:22.03.2017 32

Case No.:120/13/82-

ALC4/2014 SCIENCES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01123/AM15/ RLA File :05/23/040/00325/AM15/ Lic.No/Date:0510391947 12.11.2014 Defer Date:22.03.2017 33

Case No.:65/15/82-

ALC4/2014 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01352/AM15/ RLA File :05/23/040/00360/AM15/ Lic.No/Date:0510392011 14.11.2014 Defer Date:22.03.2017 Decision :Deferred for want of comments from AYUSH. 34

Case No.:113/18/82-

ALC4/2014 Party Name:PREGNA INTERNATIONAL LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/01479/AM15/ RLA File :03/95/040/00663/AM15/ Lic.No/Date:0310791084 14.11.2014 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.27/82/2013 dated 31.12.2012, Case No.B-427, item at Sl.No.3,

7 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. 35

Case No.:74/18/82-

ALC4/2014 Party Name:ADESHWAR MEDITEX PVT. LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01440/AM15/ RLA File :03/94/040/00814/AM15/ Lic.No/Date:0310791373 25.11.2014 Defer Date:22.03.2017 Decision :Deferred. 36

Case No.:32/2/82-ALC4/2016 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00032/AM17/ RLA File :03/95/040/00617/AM15/ Lic.No/Date:0310791470 27.11.2014 Defer Date:22.03.2017 Decision :Deferred 37

Case No.:82/18/82-

ALC4/2014 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01448/AM15/ RLA File :05/23/040/00413/AM15/ Lic.No/Date:0510392368 10.12.2014 Defer Date:22.03.2017 Decision : Deferred for want of comments from AYUSH. 38

Case No.:101/4/82-

ALC4/2015 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00140/AM16/ RLA File :17/24/040/00144/AM15/ Lic.No/Date:1710005998 10.12.2014 Defer Date:22.03.2017 Decision :Deferred. 39

Case No.:97/18/82-

ALC4/2014 Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01463/AM15/ RLA File :30/24/040/00041/AM15/ Lic.No/Date:3010103261 11.12.2014 Defer Date:22.03.2017 Decision :Deferred. 40

Case No.:2/18/82-ALC4/2014 Party Name:SWATI

MENTHOL & ALLIED CHEMICALS LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01368/AM15/ RLA File :29/24/040/00009/AM15/ Lic.No/Date:2910025185 17.12.2014 Defer Date:22.03.2017 41

Case No.:88/18/82-

ALC4/2014 Party Name:METROPOLITAN EXIMCHEM LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred

8 HQ File :01/82/050/01454/AM15/ RLA File :03/95/040/00776/AM15/ Lic.No/Date:0310792133 18.12.2014 Defer Date:22.03.2017 42

Case No.:69/18/82-

ALC4/2014 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01435/AM15/ RLA File :03/95/040/00649/AM15/ Lic.No/Date:0310792132 18.12.2014 Defer Date:22.03.2017 43

Case No.:105/18/82-

ALC4/2014 Party Name:KLJ PLASTICIZERS LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01471/AM15/ RLA File :05/23/040/00436/AM15/ Lic.No/Date:0510392586 26.12.2014 Defer Date:22.03.2017 44

Case No.:19/4/82-ALC4/2015 Party Name:J.B. CHEMICALS

& PHARMACEUTICALS LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00058/AM16/ RLA File :03/94/040/00932/AM15/ Lic.No/Date:0310792548 01.01.2015 Defer Date:22.03.2017 45

Case No.:92/5/82-ALC4/2015

Party Name:ALKALOIDS CORPORATION Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00232/AM16/ RLA File :02/24/040/00203/AM15/ Lic.No/Date:0210205448 14.01.2015 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/437/2015- PI(Norms) dated August 2016, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 46

Case No.:9/18/82-ALC4/2014 Party Name:SAIBABA

SURFACTANTS (P) LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01375/AM15/ RLA File :08/24/040/00371/AM15/ Lic.No/Date:0810134344 19.01.2015 Defer Date:22.03.2017 47

Case No.:204/5/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00344/AM16/ RLA File :09/24/040/00596/AM15/ Lic.No/Date:0910061555 23.01.2015 Defer Date:22.03.2017

9 48

Case No.:20/4/82-ALC4/2015 Party Name:D. R. COATS INK

& RESINS PVT. LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00059/AM16/ RLA File :03/94/040/00759/AM15/ Lic.No/Date:0310793542 03.02.2015 Defer Date:22.03.2017 49

Case No.:91/7/82-ALC4/2015 Party Name:SHREE GANESH

REMEDIES PVT.LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00696/AM16/ RLA File :34/24/040/00295/AM15/ Lic.No/Date:3410040965 16.02.2015 Defer Date:22.03.2017 50

Case No.:52/19/82-

ALC4/2014 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01540/AM15/ RLA File :05/24/040/00273/AM15/ Lic.No/Date:0510393248 17.02.2015 Defer Date:22.03.2017 51

Case No.:280/5/82-

ALC4/2015 Party Name:FERMENTA BIOTECH LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00420/AM16/ RLA File :03/94/040/01110/AM15/ Lic.No/Date:0310794101 24.02.2015 Defer Date:22.03.2017 Decision : Information called for from the firm in NC meeting No.06/82 dated 14.05.2016 is awaited. The Committee accordingly deferred the case. 52

Case No.:72/4/82-ALC4/2015 Party Name:LANTECH

PHARMACEUTICALS LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00111/AM16/ RLA File :09/24/040/00647/AM15/ Lic.No/Date:0910061664 04.03.2015 Defer Date:22.03.2017 Decision : Deferred for want of comments from DoP. 53

Case No.:85/4/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00124/AM16/ RLA File :09/24/040/00684/AM15/ Lic.No/Date:0910061681 11.03.2015 Defer Date:22.03.2017 Decision :Deferred. 54

Case No.:106/7/82-

ALC4/2015 Party Name:ALCHEMIE LABORATORIES Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred

10 HQ File :01/82/050/00711/AM16/ RLA File :03/94/040/00812/AM15/ Lic.No/Date:0310794612 16.03.2015 Defer Date:22.03.2017 55

Case No.:48/4/82-ALC4/2015 Party Name:MAMTA

POLYCOATS Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00087/AM16/ RLA File :34/24/040/00329/AM15/ Lic.No/Date:3410041054 17.03.2015 Defer Date:22.03.2017 56

Case No.:65/4/82-ALC4/2015 Party Name:MYLAN

Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00104/AM16/ RLA File :09/24/040/00662/AM15/ Lic.No/Date:0910061843 31.03.2015 Defer Date:22.03.2017 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/240/2015-PI(Norms) dated September 2015, uploaded at the end of these minutes and deferred the case. 57

Case No.:36/4/82-ALC4/2015 Party Name:NUTRA

SPECIALITIES PVT. LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00075/AM16/ RLA File :04/24/040/00298/AM15/ Lic.No/Date:0410160376 31.03.2015 Defer Date:22.03.2017 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/268/2015-PI(Norms) dated Oct. 2015, uploaded at the end of these minutes and deferred the case. 5 8

Case No.:78/4/82-

ALC4/2015 Party Name:SMILAX LABORATORIES LIMI TED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00117/AM 16/ RLA File :09/24/040/00710/AM15/ Lic.No/Date:09100618 58 31.03.2015 Defer Date:22.03.20 17 59

Case No.:86/4/82-ALC4/2015

Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00125/AM16/ RLA File :09/24/040/00721/AM15/ Lic.No/Date:0910061812 31.03.2015 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/264/2015- PI(Norms) dated Sept. 2015, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC.

11 60

Case No.:64/4/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00103/AM16/ RLA File :09/24/040/00595/AM15/ Lic.No/Date:0910061851 31.03.2015 Defer Date:22.03.2017 Decision :Deferred. 61

Case No.:73/4/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00112/AM16/ RLA File :09/24/040/00700/AM15/ Lic.No/Date:0910061821 31.03.2015 Defer Date:22.03.2017 Decision :Deferred. 62

Case No.:52/4/82-ALC4/2015 Party Name:PAYAL

PETROCHEM PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00091/AM16/ RLA File :05/24/040/00562/AM15/ Lic.No/Date:0510393822 01.04.2015 Defer Date:22.03.2017 Decision :Deferred. 63

Case No.:88/4/82-ALC4/2015 Party Name:INDO AMINES

LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00127/AM16/ RLA File :03/94/040/01218/AM15/ Lic.No/Date:0310795135 07.04.2015 Defer Date:22.03.2017 64

Case No.:80/4/82-ALC4/2015 Party Name:VINS

BIOPRODUCTS LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00119/AM16/ RLA File :09/24/040/00652/AM15/ Lic.No/Date:0910061882 15.04.2015 Defer Date:22.03.2017 Decision :Deferred for want of comments from DBT. 65

Case No.:76/4/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00115/AM16/ RLA File :09/24/040/00717/AM15/ Lic.No/Date:0910061893 17.04.2015 Defer Date:22.03.2017 Decision :Deferred. 66

Case No.:77/4/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00116/AM16/ RLA File :09/24/040/00738/AM15/ Lic.No/Date:0910061892 17.04.2015 Defer Date:22.03.2017 Decision :Deferred.

12 67

Case No.:66/4/82-ALC4/2015

Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00105/AM16/ RLA File :34/24/040/00010/AM16/ Lic.No/Date:3410041157 22.04.2015 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.12/82 dated 10.12.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take 68

Case No.:69/4/82-ALC4/2015

Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: approved HQ File :01/82/050/00108/AM16/ RLA File :34/24/040/00012/AM16/ Lic.No/Date:3410041158 22.04.2015 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.10/82 dated 13.11.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take 69

Case No.:83/4/82-ALC4/2015 Party Name:CONTINENTAL

CHEMICALS Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00122/AM16/ RLA File :08/24/040/00005/AM16/ Lic.No/Date:0810135094 24.04.2015 Defer Date:22.03.2017 Decision :Deferred. 70

Case No.:68/4/82-ALC4/2015

Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00107/AM16/ RLA File :34/24/040/00003/AM16/ Lic.No/Date:3410041183 28.04.2015 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.18/82 dated 02.08.2011, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take 71

Case No.:15/7/82-ALC4/2015 Party Name:MAHAVIR

SYNTHESIS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00620/AM16/ RLA File :52/24/040/00007/AM16/ Lic.No/Date:5210041517 11.05.2015 Defer Date:22.03.2017 72

Case No.:129/7/82-

ALC4/2015 Party Name:NATIONAL TUBE INDUSTRIES, Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00734/AM16/ RLA File :03/95/040/00073/AM16/ Lic.No/Date:0310795930 14.05.2015 Defer Date:22.03.2017

13 Decision :The Committee decided to call for information as per recommendation of Ministry of Small and Medium Enterprises forwarded vide O.M.No.TL-12024/30/2016- GC and F-DCMSME dated 17.02.2017, uploaded at the end of these minutes and deferred the case. 73

Case No.:102/7/82-

ALC4/2015 Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00707/AM16/ RLA File :30/24/040/00006/AM16/ Lic.No/Date:3010103498 21.05.2015 Defer Date:22.03.2017 74

Case No.:55/13/82-

ALC4/2015 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01018/AM16/ RLA File :07/24/040/00036/AM16/ Lic.No/Date:0710108251 22.05.2015 Defer Date:22.03.2017 Decision : 75

Case No.:99/4/82-ALC4/2015 Party Name:INTAS

PHARMACEUTICALS LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00138/AM16/ RLA File :08/24/040/00072/AM16/ Lic.No/Date:0810135427 03.06.2015 Defer Date:15.02.2016 76

Case No.:110/7/82-

ALC4/2015 Party Name:RISHABH METALS & CHEMICALS PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00715/AM16/ RLA File :03/95/040/00051/AM16/ Lic.No/Date:0310796383 03.06.2015 Defer Date:22.03.2017 Decision :Deferred for want of comments from MSME. 77

Case No.:17/7/82-ALC4/2015 Party Name:SUN

PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00622/AM16/ RLA File :05/24/040/00078/AM16/ Lic.No/Date:0510394418 03.06.2015 Defer Date:22.03.2017 Decision : Information called for from the firm in NC meeting No,04/82 dated 24.05.2016 is awaited. The Committee accordingly defer the case. 78

Case No.:60/4/82-ALC4/2016 Party Name:ADCOCK

INGRAM LTD, Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00123/AM17/ RLA File :07/24/040/00071/AM16/ Lic.No/Date:0710108351 10.06.2015 Defer Date:22.03.2017 Decision : Information called for from the firm in NC meeting No,12/82 dated 28.09.2016 is awaited. The Committee accordingly defer the case.

14 79

Case No.:66/7/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00671/AM16/ RLA File :09/24/040/00162/AM16/ Lic.No/Date:0910062162 10.06.2015 Defer Date:22.03.2017 Decision :Deferred. 80

Case No.:159/7/82-

ALC4/2015 Party Name:VIJAY PERFUMES PVT.LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status:Approved HQ File :01/82/050/00764/AM16/ RLA File :03/95/040/00985/AM15/ Lic.No/Date:0310796576 11.06.2015 Defer Date: Decision : The Committee decided to ratify norm on repeat basis based on the earlier decision taken by NC in its meeting No.16/82 dated 23.01.2015, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further 81

Case No.:42/13/82-

ALC4/2015 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01005/AM16/ RLA File :03/94/040/00177/AM16/ Lic.No/Date:0310796604 15.06.2015 Defer Date:22.03.2017 Decision : Information called for from the firm in NC meeting No.12 dated 28.09.2016 is awaited. The Committee accordingly deferred the case. 82

Case No.:48/19/82-

ALC4/2015 Party Name:RAJ DHANVANTRY PHARMACY Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01529/AM16/ RLA File :24/24/040/00007/AM16/ Lic.No/Date:2410041748 15.06.2015 Defer Date:22.03.2017 Decision :Deferred. 83

Case No.:41/13/82-

ALC4/2015 Party Name:DANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01004/AM16/ RLA File :03/94/040/00111/AM16/ Lic.No/Date:0310796667 16.06.2015 Defer Date:22.03.2017 Decision :Deferred. 84

Case No.:52/7/82-ALC4/2015 Party Name:JODAS EXPOIM

PVT.LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00657/AM16/ RLA File :05/23/040/00107/AM16/ Lic.No/Date:0510394590 17.06.2015 Defer Date:22.03.2017 Decision : Information called for from the firm in NC meeting No.14 dated 29.11.2016 is awaited. The Committee accordingly deferred the case.

15 85

Case No.:43/13/82-

ALC4/2015 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01006/AM16/ RLA File :03/94/040/00178/AM16/ Lic.No/Date:0310796712 18.06.2015 Defer Date:22.03.2017 Decision : The Committee decided to call for information from the firm based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/207/2016- PI(Norms) dated Sept. 2016, uploaded at the end of these minutes and deferred the case. 86

Case No.:83/13/82-ALC4/2015 Party Name:RIDDHI PHARMA Meet No/Date:18/82-

ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/01046/AM16/ RLA File :34/24/040/00087/AM16/ Lic.No/Date:3410041313 23.06.2015 Defer Date: decision taken by NC in its meeting No.49/82 dated 06.03.2012, uploaded at the end of 87

Case No.:75/7/82-ALC4/2015

Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00680/AM16/ RLA File :05/24/040/00122/AM16/ Lic.No/Date:0510394696 25.06.2015 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/634/2012- PI(Norms) dated 12.03.2013, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 88

Case No.:108/14/82-

ALC4/2015 LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01244/AM16/ RLA File :09/24/040/00183/AM16/ Lic.No/Date:0910062267 01.07.2015 Defer Date:22.03.2017 Decision :Deferred. 89

Case No.:10/13/82-

ALC4/2015 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00973/AM16/ RLA File :03/94/040/00229/AM16/ Lic.No/Date:0310797018 02.07.2015 Defer Date:22.03.2017 Decision :Deferred. 90

Case No.:11/13/82-

ALC4/2015 Party Name:AMINES & Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File RLA File Lic.No/Date:0310797020 Defer

16 :01/82/050/00974/AM16/ :03/94/040/00228/AM16/ 02.07.2015 Date:22.03.2017 91

Case No.:24/13/82-

ALC4/2015 Party Name:DANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00987/AM16/ RLA File :03/94/040/00226/AM16/ Lic.No/Date:0310797092 07.07.2015 Defer Date:22.03.2017 92

Case No.:20/16/82-

ALC4/2015 Party Name:MYLAN Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01340/AM16/ RLA File :09/24/040/00032/AM16/ Lic.No/Date:0910062338 15.07.2015 Defer Date:22.03.2017 recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/822/2015- PI(Norms) dated 23.05.2016, uploaded at the end of these minutes and deferred the case. 93

Case No.:22/13/82-

ALC4/2015 Party Name:BLISS INDASI LIFESCIENCES PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00985/AM16/ RLA File :03/94/040/00282/AM16/ Lic.No/Date:0310797355 17.07.2015 Defer Date:22.03.2017 94

Case No.:115/13/82-

ALC4/2015 Party Name:FERMENTA BIOTECH LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01078/AM16/ RLA File :03/94/040/00038/AM16/ Lic.No/Date:0310797627 24.07.2015 Defer Date:22.03.2017 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. 95

Case No.:73/8/82-ALC4/2015 Party Name:RECKITT

BENCKISER HEALTHCARE INDIA LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00869/AM16/ RLA File :05/24/040/00213/AM16/ Lic.No/Date:0510395102 28.07.2015 Defer Date:22.03.2017 Decision : 96

Case No.:116/13/82-

ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01079/AM16/ RLA File :03/94/040/00215/AM16/ Lic.No/Date:0310797864 31.07.2015 Defer Date:22.03.2017

17 Decision : 97

Case No.:112/13/82-

ALC4/2015 Party Name:K V AROCHEM PVT. LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01075/AM16/ RLA File :03/94/040/00345/AM16/ Lic.No/Date:0310797937 04.08.2015 Defer Date:22.03.2017 Decision :Deferred. 98

Case No.:109/13/82-

ALC4/2015 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01072/AM16/ RLA File :03/94/040/00170/AM16/ Lic.No/Date:0310797954 05.08.2015 Defer Date:22.03.2017 Decision : The Committee noted that information called for from the firm in NC meeting No.6/82 dated 14.06.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 99

Case No.:12/18/82-

ALC4/2015 Party Name:OMTECH CHEMICAL INDUSTRIES PVT.LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01477/AM16/ RLA File :03/95/040/00345/AM16/ Lic.No/Date:0310797967 05.08.2015 Defer Date:22.03.2017 Decision :Deferred. 100

Case No.:50/13/82-

ALC4/2015 Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01013/AM16/ RLA File :04/24/040/00095/AM16/ Lic.No/Date:0410160884 06.08.2015 Defer Date:22.03.2017 Decision :Deferred. 101

Case No.:111/13/82-

ALC4/2015 Party Name:HEMA DYE CHEM PVT. LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01074/AM16/ RLA File :03/94/040/00305/AM16/ Lic.No/Date:0310798134 13.08.2015 Defer Date:22.03.2017 102

Case No.:79/13/82-

ALC4/2015 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01042/AM16/ RLA File :52/24/040/00034/AM16/ Lic.No/Date:5210041610 14.08.2015 Defer Date:22.03.2017 103 Case No.:127/13/82- ALC4/2015 Party Name:ASTEC LIFESCIENCES LTD., Meet No/Date:18/82- ALC4/2016 Status: Deferred

18 15.02.2017 HQ File :01/82/050/01090/AM16/ RLA File :03/94/040/00878/AM15/ Lic.No/Date:0310798205 17.08.2015 Defer Date:22.03.2017 104

Case No.:126/13/82-

ALC4/2015 Party Name:ASTEC LIFESCIENCES LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01089/AM16/ RLA File :03/94/040/00879/AM15/ Lic.No/Date:0310798319 20.08.2015 Defer Date:22.03.2017 105

Case No.:61/13/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01024/AM16/ RLA File :05/23/040/00218/AM16/ Lic.No/Date:0510395388 20.08.2015 Defer Date:22.03.2017 Decision : : Information called for from the firm in NC 08/82 dated 27.07.2016 is awaited. The Committee accordingly deferred the case. 106

Case No.:161/13/82-

ALC4/2015 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01124/AM16/ RLA File :03/95/040/00274/AM16/ Lic.No/Date:0310798374 21.08.2015 Defer Date:22.03.2017 Decision :Deferred. 107

Case No.:77/13/82-

ALC4/2015 Party Name:ARKRAY HEALTHCARE PVT.LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01040/AM16/ RLA File :52/24/040/00038/AM16/ Lic.No/Date:5210041620 27.08.2015 Defer Date:22.03.2017 Decision : : Information called for from the firm in NC 10/82 dated 23.08.2016 is awaited. The Committee accordingly deferred the case. 108

Case No.:59/11/82-

ALC4/2016 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00593/AM17/ RLA File :52/24/040/00040/AM16/ Lic.No/Date:5210041626 04.09.2015 Defer Date:22.03.2017 109

Case No.:5/18/82-ALC4/2015 Party Name:AMI ORGANICS

PVT LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01470/AM16/ RLA File :52/24/040/00039/AM16/ Lic.No/Date:5210041625 04.09.2015 Defer Date:22.03.2017

19 110

Case No.:59/4/82-ALC4/2016 Party

Name:ADCOCK INGRAM LTD, Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00122/AM17/ RLA File :07/24/040/00180/AM16/ Lic.No/Date:0710108694 07.09.2015 Defer Date:22.03.2017 Decision : The Committee noted that information called for from the firm in NC meeting No.12/82 dated 28.09.2016 is awaited. The Committee accordingly deferred the case. 111

Case No.:8/16/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01328/AM16/ RLA File :09/24/040/00294/AM16/ Lic.No/Date:0910062666 28.09.2015 Defer Date:22.03.2017 Decision :Deferred. 112

Case No.:12/19/82-

ALC4/2015 Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01492/AM16/ RLA File :04/24/040/00154/AM16/ Lic.No/Date:0410161070 01.10.2015 Defer Date:22.03.2017 Decision :Deferred. 113

Case No.:130/14/82-

ALC4/2015 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01266/AM16/ RLA File :05/24/040/00317/AM16/ Lic.No/Date:0510395874 09.10.2015 Defer Date:22.03.2017 Decision :Deferred. 114

Case No.:144/14/82-

ALC4/2015 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01280/AM16/ RLA File :52/24/040/00049/AM16/ Lic.No/Date:5210041658 14.10.2015 Defer Date:22.03.2017 Decision :Deferred. 115

Case No.:135/13/82-

ALC4/2015 Party Name:MYLAN Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01098/AM16/ RLA File :09/24/040/00408/AM16/ Lic.No/Date:0910062740 14.10.2015 Defer Date:22.03.2017 Decision : 116

Case No.:24/16/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File RLA File Lic.No/Date:0910062727 Defer

20 :01/82/050/01344/AM16/ :09/24/040/00380/AM16/ 14.10.2015 Date:22.03.2017 Decision :Deferred. 117

Case No.:136/13/82-

ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01099/AM16/ RLA File :08/24/040/00207/AM16/ Lic.No/Date:0810136320 16.10.2015 Defer Date:22.03.2017 Decision :Deferred. 118

Case No.:77/16/82-

ALC4/2015 Party Name:LACTOSE (INDIA) LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01397/AM16/ RLA File :03/95/040/00481/AM16/ Lic.No/Date:0310799561 20.10.2015 Defer Date:22.03.2017 Decision :Deferred. 119

Case No.:140/13/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01103/AM16/ RLA File :03/95/040/00503/AM16/ Lic.No/Date:0310799583 21.10.2015 Defer Date:22.03.2017 Decision :Deferred. 120

Case No.:141/13/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01104/AM16/ RLA File :03/95/040/00504/AM16/ Lic.No/Date:0310799629 23.10.2015 Defer Date:22.03.2017 Decision :Deferred. 121

Case No.:142/13/82-

ALC4/2015 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01105/AM16/ RLA File :09/24/040/00443/AM16/ Lic.No/Date:0910062774 27.10.2015 Defer Date:22.03.2017 Decision :Deferred. 122

Case No.:147/13/82-

ALC4/2015 Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01110/AM16/ RLA File :08/24/040/00241/AM16/ Lic.No/Date:0810136382 29.10.2015 Defer Date:22.03.2017 Decision :Deferred. 123 Case No.:64/19/82- ALC4/2015 Party Name:INDO AMINES LIMITED Meet No/Date:18/82- ALC4/2016 Status: Deferred

21 15.02.2017 HQ File :01/82/050/01545/AM16/ RLA File :03/94/040/00240/AM16/ Lic.No/Date:0310799907 30.10.2015 Defer Date:22.03.2017 124

Case No.:65/19/82-

ALC4/2015 Party Name:INDO AMINES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01546/AM16/ RLA File :03/94/040/00059/AM16/ Lic.No/Date:0310799906 30.10.2015 Defer Date:22.03.2017 125

Case No.:66/19/82-

ALC4/2015 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01547/AM16/ RLA File :03/94/040/00582/AM16/ Lic.No/Date:0310799943 02.11.2015 Defer Date:22.03.2017 126

Case No.:38/21/82-

ALC4/2015 Party Name:VINS BIOPRODUCTS LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01743/AM16/ RLA File :09/24/040/00442/AM16/ Lic.No/Date:0910062831 03.11.2015 Defer Date:22.03.2017 Decision :Deferred for want of comments from DBT. 127

Case No.:159/13/82-

ALC4/2015 Party Name:CHEMCON SPECIALITY CHEMICALS P LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01122/AM16/ RLA File :34/24/040/00205/AM16/ Lic.No/Date:3410041650 04.11.2015 Defer Date:22.03.2017 Decision :Deferred. 128

Case No.:57/19/82-

ALC4/2015 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01538/AM16/ RLA File :03/94/040/00443/AM16/ Lic.No/Date:0310800060 05.11.2015 Defer Date:22.03.2017 129

Case No.:18/21/82-

ALC4/2015 Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01723/AM16/ RLA File :09/24/040/00487/AM16/ Lic.No/Date:0910062841 06.11.2015 Defer Date:22.03.2017

22 130

Case No.:2/16/82-ALC4/2015 Party Name:SANO

MEDICAL KITS PVT. LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01322/AM16/ RLA File :04/24/040/00175/AM16/ Lic.No/Date:0410161296 09.11.2015 Defer Date:22.03.2017 Decision :Information has been received and sent to DoP for comments. 131

Case No.:165/13/82-

ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01128/AM16/ RLA File :52/24/040/00050/AM16/ Lic.No/Date:5210041688 12.11.2015 Defer Date:22.03.2017 Decision :Deferred. 132

Case No.:71/19/82-

ALC4/2015 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01552/AM16/ RLA File :03/94/040/00613/AM16/ Lic.No/Date:0310800272 17.11.2015 Defer Date:22.03.2017 133

Case No.:72/19/82-

ALC4/2015 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01553/AM16/ RLA File :03/94/040/00612/AM16/ Lic.No/Date:0310800271 17.11.2015 Defer Date:22.03.2017 134

Case No.:58/19/82-

ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01539/AM16/ RLA File :03/94/040/00572/AM16/ Lic.No/Date:0310800324 19.11.2015 Defer Date:22.03.2017 135

Case No.:60/19/82-

ALC4/2015 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01541/AM16/ RLA File :03/94/040/00661/AM16/ Lic.No/Date:0310800340 20.11.2015 Defer Date:22.03.2017 136

Case No.:20/19/82-

ALC4/2015 Party Name:VDH CHEM TECH PVT. LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01500/AM16/ RLA File :05/24/040/00369/AM16/ Lic.No/Date:0510396413 24.11.2015 Defer Date:22.03.2017

23 137

Case No.:59/19/82-

ALC4/2015 Party Name:EXCEL INDUSTRIES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01540/AM16/ RLA File :03/94/040/00251/AM16/ Lic.No/Date:0310800536 01.12.2015 Defer Date:22.03.2017 138

Case No.:62/19/82-

ALC4/2015 Party Name:EXCEL INDUSTRIES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01543/AM16/ RLA File :03/94/040/00252/AM16/ Lic.No/Date:0310800539 01.12.2015 Defer Date:22.03.2017 139

Case No.:61/19/82-

ALC4/2015 Party Name:K V AROCHEM PVT. LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01542/AM16/ RLA File :03/94/040/00440/AM16/ Lic.No/Date:0310800529 01.12.2015 Defer Date:22.03.2017 140

Case No.:17/19/82-

ALC4/2015 SCIENCES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01497/AM16/ RLA File :05/23/040/00002/AM16/ Lic.No/Date:0510396500 03.12.2015 Defer Date:22.03.2017 141

Case No.:38/19/82-

ALC4/2015 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01519/AM16/ RLA File :52/24/040/00062/AM16/ Lic.No/Date:5210041707 04.12.2015 Defer Date:22.03.2017 142

Case No.:1/8/82-ALC4/2016

Party Name:SWATI MENTHOL & ALLIED CHEMICALS LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00339/AM17/ RLA File :29/24/040/00007/AM16/ Lic.No/Date:2910025232 04.12.2015 Defer Date:22.03.2017 143

Case No.:90/19/82-ALC4/2015 Party Name:VENUS

REMEDIES LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/01571/AM16/ RLA File :22/24/040/00082/AM16/ Lic.No/Date:2210015359 07.12.2015 Defer Date:

24 Decision : The Committee decided to ratify norms on repeat basis based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/109/2015- PI(Norms) dated Oct. 2015, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 144

Case No.:40/19/82-

ALC4/2015 SCIENCES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01521/AM16/ RLA File :05/23/040/00240/AM16/ Lic.No/Date:0510396587 10.12.2015 Defer Date:22.03.2017 145

Case No.:88/19/82-

ALC4/2015 Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01569/AM16/ RLA File :22/24/040/00081/AM16/ Lic.No/Date:2210015365 10.12.2015 Defer Date:22.03.2017 146

Case No.:56/21/82-

ALC4/2015 LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01761/AM16/ RLA File :09/24/040/00523/AM16/ Lic.No/Date:0910062965 11.12.2015 Defer Date:22.03.2017 147

Case No.:30/19/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01510/AM16/ RLA File :05/24/040/00401/AM16/ Lic.No/Date:0510396611 14.12.2015 Defer Date:22.03.2017 148

Case No.:31/19/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01511/AM16/ RLA File :05/24/040/00375/AM16/ Lic.No/Date:0510396609 14.12.2015 Defer Date:22.03.2017 149

Case No.:32/19/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01513/AM16/ RLA File :05/24/040/00381/AM16/ Lic.No/Date:0510396610 14.12.2015 Defer Date:22.03.2017

25 150

Case No.:18/19/82-

ALC4/2015 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01498/AM16/ RLA File :52/24/040/00064/AM16/ Lic.No/Date:5210041711 15.12.2015 Defer Date:22.03.2017 151

Case No.:39/19/82-

ALC4/2015 SCIENCES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01520/AM16/ RLA File :05/23/040/00360/AM16/ Lic.No/Date:0510396634 16.12.2015 Defer Date:22.03.2017 152

Case No.:41/19/82-

ALC4/2015 SCIENCES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01522/AM16/ RLA File :05/23/040/00001/AM16/ Lic.No/Date:0510396632 16.12.2015 Defer Date:22.03.2017 153

Case No.:42/19/82-

ALC4/2015 SCIENCES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01523/AM16/ RLA File :05/23/040/00192/AM16/ Lic.No/Date:0510396633 16.12.2015 Defer Date:22.03.2017 154

Case No.:36/19/82-

ALC4/2015 Party Name:PANACEA BIOTEC LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01517/AM16/ RLA File :05/24/040/00439/AM16/ Lic.No/Date:0510396670 18.12.2015 Defer Date:22.03.2017 Decision :Deferred for want of comments from DBT. 155

Case No.:35/19/82-

ALC4/2015 Party Name:HELLO PAINTS (P) LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01516/AM16/ RLA File :05/23/040/00396/AM16/ Lic.No/Date:0510396751 21.12.2015 Defer Date:22.03.2017 156

Case No.:33/19/82-

ALC4/2015 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01514/AM16/ RLA File :05/24/040/00448/AM16/ Lic.No/Date:0510396777 21.12.2015 Defer Date:22.03.2017

26 157

Case No.:54/21/82-

ALC4/2015 LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01759/AM16/ RLA File :09/24/040/00525/AM16/ Lic.No/Date:0910063015 21.12.2015 Defer Date:22.03.2017 158

Case No.:61/21/82-

ALC4/2015 LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01766/AM16/ RLA File :09/24/040/00547/AM16/ Lic.No/Date:0910063018 21.12.2015 Defer Date:22.03.2017 159

Case No.:22/19/82-

ALC4/2015 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01502/AM16/ RLA File :05/23/040/00244/AM16/ Lic.No/Date:0510397137 30.12.2015 Defer Date:22.03.2017 Decision : Information called for from the firm in NC meeting No.06/82 dated 14.06.2016 is awaited. 160

Case No.:23/19/82-

ALC4/2015 KABI ONCOLOGY LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01503/AM16/ RLA File :05/23/040/00260/AM16/ Lic.No/Date:0510397138 30.12.2015 Defer Date:22.03.2017 Decision : Information called for from the firm in NC meeting No.06/82 dated 14.06.2016 is awaited. 161

Case No.:13/19/82-

ALC4/2015 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01493/AM16/ RLA File :04/24/040/00213/AM16/ Lic.No/Date:0410161479 30.12.2015 Defer Date:22.03.2017 Decision : Information called for from the firm in NC meeting No.04/82 dated 24.05.2016 is awaited. 162

Case No.:47/21/82-

ALC4/2015 Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01752/AM16/ RLA File :09/24/040/00570/AM16/ Lic.No/Date:0910063087 01.01.2016 Defer Date:22.03.2017 Decision :Deferred.

27 163

Case No.:35/21/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01740/AM16/ RLA File :31/83/040/00094/AM16/ Lic.No/Date:3110065843 01.01.2016 Defer Date:22.03.2017 164

Case No.:2/17/82-ALC4/2015 Party Name:ARENE LIFE

SCIENCES LIMITED. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01462/AM16/ RLA File :09/24/040/00571/AM16/ Lic.No/Date:0910063114 08.01.2016 Defer Date:22.03.2017 Decision : : Information called for from the firm in NC meeting No.12/82 dated 28.09.2016 is awaited. 165

Case No.:5/17/82-ALC4/2015 Party Name:DYNAMIC

SPECIALITY CHEMICALS LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01465/AM16/ RLA File :30/24/040/00035/AM16/ Lic.No/Date:3010103695 11.01.2016 Defer Date:22.03.2017 Decision :Deferred. 166

Case No.:60/21/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01765/AM16/ RLA File :09/24/040/00581/AM16/ Lic.No/Date:0910063135 13.01.2016 Defer Date:22.03.2017 Decision :Deferred. 167

Case No.:37/2/82-ALC4/2016 Party Name:ALKALOIDS

CORPORATION Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00037/AM17/ RLA File :02/24/040/00181/AM16/ Lic.No/Date:0210206452 19.01.2016 Defer Date:22.03.2017 Decision : : Information called for from the firm in NC meeting No.12/82 dated 28.09.2016 is awaited. 168

Case No.:24/21/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01729/AM16/ RLA File :34/24/040/00267/AM16/ Lic.No/Date:3410041832 28.01.2016 Defer Date:22.03.2017 Decision :Deferred. 169

Case No.:17/10/82-

ALC4/2016 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File RLA File Lic.No/Date:2210015407 Defer

28 :01/82/050/00363/AM17/ :22/24/040/00104/AM16/ 01.02.2016 Date:22.03.2017 Decision :Deferred for want of comments DoP. 170

Case No.:8/21/82-ALC4/2015

Party Name:JUBILANT GENERICS LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/01713/AM16/ RLA File :05/23/040/00438/AM16/ Lic.No/Date:0510397455 01.02.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/410/2014- PI(Norms) dated January 2015, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 171

Case No.:13/21/82-

ALC4/2015 SCIENCES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01718/AM16/ RLA File :05/23/040/00439/AM16/ Lic.No/Date:0510397481 03.02.2016 Defer Date:22.03.2017 172

Case No.:1/19/82-ALC4/2015 Party Name:AUROBINDO

PHARMA LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01481/AM16/ RLA File :09/24/040/00634/AM16/ Lic.No/Date:0910063213 04.02.2016 Defer Date:22.03.2017 173

Case No.:4/19/82-ALC4/2015 Party Name:ALPHAMED

FORMULATIONS P LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01484/AM16/ RLA File :09/24/040/00628/AM16/ Lic.No/Date:0910063226 05.02.2016 Defer Date:22.03.2017 Decision : Information called for from the firm in NC meeting No.08/82 dated 27.07.2016 is awaited. 174

Case No.:25/21/82-

ALC4/2015 Party Name:RONAK CHEMICALS Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01730/AM16/ RLA File :34/24/040/00274/AM16/ Lic.No/Date:3410041858 05.02.2016 Defer Date:22.03.2017 Decision :Deferred. 175

Case No.:26/21/82-

ALC4/2015 Party Name:RONAK CHEMICALS Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01731/AM16/ RLA File :34/24/040/00273/AM16/ Lic.No/Date:3410041857 05.02.2016 Defer Date:22.03.2017

29 Decision :Deferred. 176

Case No.:14/21/82-

ALC4/2015 Party Name:DHAMPUR SUGAR MILLS LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01719/AM16/ RLA File :05/23/040/00456/AM16/ Lic.No/Date:0510397521 08.02.2016 Defer Date:22.03.2017 Decision :Deferred. 177

Case No.:5/19/82-ALC4/2015 Party Name:GOPINATH

CHEM-TECH LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01485/AM16/ RLA File :08/24/040/00291/AM16/ Lic.No/Date:0810137155 08.02.2016 Defer Date:22.03.2017 Decision :Deferred. 178

Case No.:62/4/82-ALC4/2016 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00125/AM17/ RLA File :03/95/040/00568/AM16/ Lic.No/Date:0310802284 08.02.2016 Defer Date:22.03.2017 Decision :Deferred. 179

Case No.:85/19/82-

ALC4/2015 Party Name:ANUPAM RASAYAN (INDIA) LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01566/AM16/ RLA File :52/24/040/00076/AM16/ Lic.No/Date:5210041759 09.02.2016 Defer Date:22.03.2017 Decision :Deferred. 180

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

Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00008/AM17/ RLA File :34/24/040/00284/AM16/ Lic.No/Date:3410041870 10.02.2016 Defer Date:22.03.2017 Decision :Deferred. 181

Case No.:15/10/82-

ALC4/2016 Party Name:INFINITY LABORATORIES PVT.LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00361/AM17/ RLA File :22/24/040/00107/AM16/ Lic.No/Date:2210015412 10.02.2016 Defer Date:22.03.2017 182

Case No.:30/21/82-

ALC4/2015 PVT.LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred

30 HQ File :01/82/050/01735/AM16/ RLA File :05/23/040/00467/AM16/ Lic.No/Date:0510397580 10.02.2016 Defer Date:22.03.2017 183

Case No.:36/2/82-ALC4/2016 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00036/AM17/ RLA File :03/95/040/00870/AM16/ Lic.No/Date:0310802475 11.02.2016 Defer Date:22.03.2017 Decision :Deferred. 184

Case No.:5/2/82-ALC4/2016

Party Name:MAMTA POLYCOATS Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00005/AM17/ RLA File :34/24/040/00293/AM16/ Lic.No/Date:3410041887 16.02.2016 Defer Date:22.03.2017 Decision :Deferred. 185

Case No.:13/10/82-

ALC4/2016 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00359/AM17/ RLA File :22/24/040/00109/AM16/ Lic.No/Date:2210015417 17.02.2016 Defer Date:22.03.2017 186

Case No.:55/2/82-ALC4/2016 Party Name:MAHARSHI

PHARMA CHEM PVT.LTD, Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00055/AM17/ RLA File :08/24/040/00392/AM16/ Lic.No/Date:0810137224 17.02.2016 Defer Date:22.03.2017 Decision : Information called for from the firm in NC meeting No.08/82 dated 27.07.2016 is awaited. The Committee accordingly deferred the case. 187

Case No.:35/2/82-ALC4/2016 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00035/AM17/ RLA File :03/95/040/00868/AM16/ Lic.No/Date:0310802660 17.02.2016 Defer Date:22.03.2017 Decision :Deferred. 188

Case No.:102/19/82-

ALC4/2015 LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01583/AM16/ RLA File :09/24/040/00666/AM16/ Lic.No/Date:0910063280 17.02.2016 Defer Date:22.03.2017 Decision :Deferred.

31 189

Case No.:20/4/82-ALC4/2016 Party Name:JUBILANT

GENERICS LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00083/AM17/ RLA File :05/23/040/00469/AM16/ Lic.No/Date:0510397644 18.02.2016 Defer Date:22.03.2017 190

Case No.:23/4/82-ALC4/2016

Party Name:JUBILANT GENERICS LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00086/AM17/ RLA File :05/23/040/00470/AM16/ Lic.No/Date:0510397643 18.02.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/38/2012- PI(Norms) dated 13.07.2012, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 191

Case No.:34/2/82-ALC4/2016 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00034/AM17/ RLA File :03/95/040/00888/AM16/ Lic.No/Date:0310802715 19.02.2016 Defer Date:22.03.2017 Decision :Deferred. 192

Case No.:18/4/82-ALC4/2016 Party Name:VDH CHEM

TECH PVT. LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00081/AM17/ RLA File :05/24/040/00550/AM16/ Lic.No/Date:0510397711 24.02.2016 Defer Date:22.03.2017 Decision :Deferred. 193

Case No.:24/4/82-ALC4/2016 Party Name:JUBILANT LIFE

SCIENCES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00087/AM17/ RLA File :05/23/040/00491/AM16/ Lic.No/Date:0510397731 26.02.2016 Defer Date:22.03.2017 194

Case No.:4/2/82-ALC4/2016

Party Name:RIDDHI PHARMA Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00004/AM17/ RLA File :34/24/040/00301/AM16/ Lic.No/Date:3410041924 26.02.2016 Defer Date:22.03.2017 195 Case No.:84/4/82-ALC4/2016 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:18/82- ALC4/2016 Status: Deferred

32 15.02.2017 HQ File :01/82/050/00147/AM17/ RLA File :09/24/040/00648/AM16/ Lic.No/Date:0910063326 26.02.2016 Defer Date:22.03.2017 Decision :Deferred. 196

Case No.:6/2/82-ALC4/2016

Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00006/AM17/ RLA File :34/24/040/00308/AM16/ Lic.No/Date:3410041932 01.03.2016 Defer Date:22.03.2017 197

Case No.:42/2/82-ALC4/2016 Party Name:NEW

ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00042/AM17/ RLA File :03/95/040/00939/AM16/ Lic.No/Date:0310802934 01.03.2016 Defer Date:22.03.2017 Decision :Deferred. 198

Case No.:14/2/82-ALC4/2016 Party Name:SHIVA

PHARMACHEM LTD, Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00014/AM17/ RLA File :34/24/040/00221/AM16/ Lic.No/Date:3410041935 01.03.2016 Defer Date:22.03.2017 Decision :Deferred. 199

Case No.:28/4/82-ALC4/2016 Party Name:AVA

CHEMICALS PVT.LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00091/AM17/ RLA File :03/94/040/00959/AM16/ Lic.No/Date:0310803032 03.03.2016 Defer Date:22.03.2017 200

Case No.:67/7/82-ALC4/2016 Party Name:BIOLOGICAL E

LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00241/AM17/ RLA File :09/24/040/00714/AM16/ Lic.No/Date:0910063353 03.03.2016 Defer Date:22.03.2017 Decision : The Committee decided call for information from the firm based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/203/2016- PI(Norms) dated August 2016, uploaded at the end of these minutes and deferred the case. 201

Case No.:50/2/82-ALC4/2016 Party Name:PANERA

BIOTEC PVT.LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00050/AM17/ RLA File :05/24/040/00597/AM16/ Lic.No/Date:0510397827 04.03.2016 Defer Date:22.03.2017

33 Decision : Deferred for want of comments from DBT. 202

Case No.:66/4/82-ALC4/2016 Party Name:STRIDES

SHASUN LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00129/AM17/ RLA File :04/24/040/00257/AM16/ Lic.No/Date:0410161685 04.03.2016 Defer Date:22.03.2017 recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/101/2016- PI(Norms) dated August 2016, uploaded at the end of these minutes and deferred the case. 203

Case No.:67/4/82-ALC4/2016 Party Name:STRIDES

SHASUN LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00130/AM17/ RLA File :04/24/040/00256/AM16/ Lic.No/Date:0410161684 04.03.2016 Defer Date:22.03.2017 recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/101/2016- PI(Norms) dated August 2016, uploaded at the end of these minutes and deferred the case. 204

Case No.:40/4/82-ALC4/2016 Party Name:BTL EXPORTS

PVT. LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00103/AM17/ RLA File :03/94/040/01017/AM16/ Lic.No/Date:0310803105 07.03.2016 Defer Date:22.03.2017 Decision : The Committee noted that information was called for from the firm in NC meeting No.14/82 dated 29.11.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 205

Case No.:41/4/82-ALC4/2016 Party Name:BTL EXPORTS

PVT. LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00104/AM17/ RLA File :03/94/040/01018/AM16/ Lic.No/Date:0310803103 07.03.2016 Defer Date:22.03.2017 Decision : The Committee noted that information was called for from the firm in NC meeting No.14/82 dated 29.11.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 206

Case No.:57/4/82-ALC4/2016 Party Name:CLARIANT

INDIA LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00120/AM17/ RLA File :03/94/040/01041/AM16/ Lic.No/Date:0310803137 08.03.2016 Defer Date:22.03.2017 Decision :Deferred.

34 207

Case No.:7/2/82-ALC4/2016

Party Name:SONGWON SPECIALTY CHEMICALS INDIA PVT. LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00007/AM17/ RLA File :34/24/040/00323/AM16/ Lic.No/Date:3410041954 08.03.2016 Defer Date:22.03.2017 Decision :Deferred. 208

Case No.:55/4/82-ALC4/2016 Party Name:ENCUBE

ETHICALS PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00118/AM17/ RLA File :03/94/040/01044/AM16/ Lic.No/Date:0310803171 09.03.2016 Defer Date:22.03.2017 209

Case No.:30/2/82-ALC4/2016 Party Name:NEW

ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00030/AM17/ RLA File :03/95/040/00940/AM16/ Lic.No/Date:0310803176 09.03.2016 Defer Date:22.03.2017 Decision :Deferred. 210

Case No.:31/2/82-ALC4/2016 Party Name:NEW

ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00031/AM17/ RLA File :03/95/040/00931/AM16/ Lic.No/Date:0310803177 09.03.2016 Defer Date:22.03.2017 Decision :Deferred. 211

Case No.:3/2/82-ALC4/2016

Party Name:RONAK CHEMICALS Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00003/AM17/ RLA File :34/24/040/00329/AM16/ Lic.No/Date:3410041957 09.03.2016 Defer Date:22.03.2017 Decision :Deferred. 212

Case No.:13/1/82-ALC1/2016 Party Name:ONEIRO

CHEMICALS LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/01787/AM16/ RLA File :34/24/040/00286/AM16/ Lic.No/Date:3410041972 14.03.2016 Defer Date:22.03.2017 Decision :Deferred. 213

Case No.:37/4/82-ALC4/2016 Party Name:GLOBE

TROTTERS PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00100/AM17/ RLA File :03/94/040/00962/AM16/ Lic.No/Date:0310803341 15.03.2016 Defer Date:22.03.2017 Decision : DML called for from the firm by NC in its meeting No.14 dated 29.11.2016

35 is awaited. The Committee accordingly deferred the case. 214

Case No.:26/4/82-ALC4/2016 Party Name:BENZO CHEM

INDUSTRIES PRIVATE LIMITED, Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00089/AM17/ RLA File :03/94/040/01057/AM16/ Lic.No/Date:0310803376 16.03.2016 Defer Date:22.03.2017 Decision :Deferred. 215

Case No.:7/4/82-ALC4/2016

SCIENCES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00070/AM17/ RLA File :05/23/040/00468/AM16/ Lic.No/Date:0510397952 17.03.2016 Defer Date:22.03.2017 Decision :Deferred. 216

Case No.:13/4/82-ALC4/2016 Party Name:JUBILANT LIFE

SCIENCES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00076/AM17/ RLA File :05/23/040/00390/AM16/ Lic.No/Date:0510397953 17.03.2016 Defer Date:22.03.2017 Decision :Deferred. 217

Case No.:8/4/82-ALC4/2016

PVT.LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00071/AM17/ RLA File :05/23/040/00541/AM16/ Lic.No/Date:0510397985 18.03.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/9/2016-PI(Norms) dated 14.02.2017, 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. 218

Case No.:85/4/82-ALC4/2016 Party Name:SYNTHO

CHIRALS PVT. LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00148/AM17/ RLA File :09/24/040/00742/AM16/ Lic.No/Date:0910063432 18.03.2016 Defer Date:22.03.2017 Decision :Deferred. 219

Case No.:36/4/82-ALC4/2016 Party Name:INDOFIL

INDUSTRIES LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00099/AM17/ RLA File :03/94/040/01056/AM16/ Lic.No/Date:0310803468 21.03.2016 Defer Date:22.03.2017 Decision :Deferred. 220 Case No.:81/4/82-ALC4/2016 Party Name:SURVIVAL Meet No/Date:18/82- Status:

36 TECHNOLOGIES PVT.LTD. ALC4/2016 15.02.2017 Deferred HQ File :01/82/050/00144/AM17/ RLA File :03/95/040/00984/AM16/ Lic.No/Date:0310803500 22.03.2016 Defer Date:22.03.2017 Decision :Deferred. 221

Case No.:50/4/82-ALC4/2016 Party Name:AVA

CHEMICALS PVT.LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00113/AM17/ RLA File :03/94/040/01070/AM16/ Lic.No/Date:0310803526 23.03.2016 Defer Date:22.03.2017 Decision :Deferred. 222

Case No.:108/7/82-

ALC4/2016 KABI ONCOLOGY LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00282/AM17/ RLA File :05/23/040/00518/AM16/ Lic.No/Date:0510398017 23.03.2016 Defer Date:22.03.2017 Decision :Deferred. 223

Case No.:186/10/82-

ALC4/2016 Party Name:VOVANTIS LABORATORIES PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00532/AM17/ RLA File :34/24/040/00290/AM16/ Lic.No/Date:3410042021 30.03.2016 Defer Date:22.03.2017 Decision :Deferred. 224

Case No.:43/4/82-ALC4/2016 Party Name:AARTI

INDUSTRIES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00106/AM17/ RLA File :03/94/040/01108/AM16/ Lic.No/Date:0310803663 31.03.2016 Defer Date:22.03.2017 Decision :Deferred. 225

Case No.:69/4/82-ALC4/2016 Party Name:MALLADI

DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00132/AM17/ RLA File :04/24/040/00275/AM16/ Lic.No/Date:0410161762 31.03.2016 Defer Date:22.03.2017 Decision :Deferred. 226

Case No.:76/4/82-ALC4/2016 Party

Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00139/AM17/ RLA File :03/95/040/01015/AM16/ Lic.No/Date:0310803674 31.03.2016 Defer Date:22.03.2017 Decision :Deferred.

37 227

Case No.:8/10/82-ALC4/2016 Party Name:BLUE CIRCLE

ORGANICS PVT. LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00354/AM17/ RLA File :03/94/040/00645/AM16/ Lic.No/Date:0310803722 01.04.2016 Defer Date:22.03.2017 Decision :Deferred. 228

Case No.:92/4/82-ALC4/2016 Party Name:SWATI

MENTHOL & ALLIED CHEMICALS LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00155/AM17/ RLA File :29/24/040/00010/AM16/ Lic.No/Date:2910025244 06.04.2016 Defer Date:22.03.2017 Decision :Deferred. 229

Case No.:66/2/82-ALC4/2016

Party Name:ENCEE AROMATICS PVT. LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00060/AM17/ RLA File :32/24/040/00043/AM16/ Lic.No/Date:3210077862 13.04.2016 Defer Date: decision taken by NC in its meeting No.14/82 dated 24.10.2013, uploaded at the end of 230

Case No.:167/10/82-

ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00513/AM17/ RLA File :09/24/040/00777/AM16/ Lic.No/Date:0910063505 15.04.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/138/2016-PI(Norms) dated August 2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 231

Case No.:127/10/82-

ALC4/2016 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00473/AM17/ RLA File :09/24/040/00008/AM17/ Lic.No/Date:0910063506 18.04.2016 Defer Date: decision taken by NC in its meeting No.23/82 dated 06.03.2014, uploaded at the end of 232

Case No.:86/4/82-ALC4/2016 Party Name:AMI ORGANICS

PVT LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File RLA File Lic.No/Date:5210041862 Defer

38 :01/82/050/00149/AM17/ :52/24/040/00001/AM17/ 19.04.2016 Date:22.03.2017 233

Case No.:164/10/82-

ALC4/2016 Party Name:GLAND PHARMA LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00510/AM17/ RLA File :09/24/040/00767/AM16/ Lic.No/Date:0910063540 22.04.2016 Defer Date:22.03.2017 234

Case No.:125/10/82-

ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00471/AM17/ RLA File :09/24/040/00033/AM17/ Lic.No/Date:0910063570 29.04.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/138/2016-PI(Norms) dated August 2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 235

Case No.:7/6/82-ALC4/2016

Party Name:MANGALAM ORGANICS LIMITED (FORMERLY DUJODWALA Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00174/AM17/ RLA File :03/95/040/00013/AM17/ Lic.No/Date:0310804365 03.05.2016 Defer Date:22.03.2017 Decision :Deferred. 236

Case No.:174/10/82-

ALC4/2016 KABI ONCOLOGY LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00520/AM17/ RLA File :05/23/040/00038/AM17/ Lic.No/Date:0510398377 04.05.2016 Defer Date:22.03.2017 237

Case No.:175/10/82-

ALC4/2016 Party Name:KLJ Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00521/AM17/ RLA File :05/23/040/00032/AM17/ Lic.No/Date:0510398379 04.05.2016 Defer Date:22.03.2017 Decision :Deferred. 238

Case No.:132/10/82-

ALC4/2016 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00478/AM17/ RLA File :09/24/040/00040/AM17/ Lic.No/Date:0910063583 04.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/505/2013-PI(Norms) dated Oct. 2013, uploaded

39 at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP 239

Case No.:181/10/82-

ALC4/2016 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00527/AM17/ RLA File :34/24/040/00021/AM17/ Lic.No/Date:3410042142 05.05.2016 Defer Date:22.03.2017 Decision : 240

Case No.:6/10/82-ALC4/2016

Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00352/AM17/ RLA File :05/24/040/00054/AM17/ Lic.No/Date:0510398413 06.05.2016 Defer Date: decision taken by NC in its meeting No.14/82 dated 24.10.2013, uploaded at the end of 241

Case No.:146/10/82-

ALC4/2016 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00492/AM17/ RLA File :09/24/040/00044/AM17/ Lic.No/Date:0910063608 09.05.2016 Defer Date:22.03.2017 Decision : 242

Case No.:178/10/82-

ALC4/2016 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00524/AM17/ RLA File :34/24/040/00354/AM16/ Lic.No/Date:3410042154 10.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/819/2015-PI(Norms) dated 05.05.2016, uploaded 243

Case No.:77/10/82-

ALC4/2016 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00423/AM17/ RLA File :13/24/040/00004/AM17/ Lic.No/Date:1310048244 11.05.2016 Defer Date:22.03.2017 Decision : The Committee based on the recommendation of D/o Pharmaceuticals vide letter dated 06.09.2016 decided to call for copy valid DML from the firm and deferred the case. 244

Case No.:71/10/82-ALC4/2016 Party Name:SENTISS

PHARMA PVT.LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File RLA File Lic.No/Date:0510398495 Defer Date:

40 :01/82/050/00417/AM17/ :05/24/040/00056/AM17/ 13.05.2016 Pharmaceuticals forwarded vide O.M.No.35011/316/2013-PI(Norms) dated 03.07.2013, uploaded 245

Case No.:1/18/82-ALC4/2016

Party Name:UNIMAX LABORATORIES PVT.LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/01176/AM17/ RLA File :03/95/040/00095/AM17/ Lic.No/Date:0310804668 13.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/218/2015-PI(Norms) dated sept. 2015, uploaded 246

Case No.:169/10/82-

ALC4/2016 Party Name:BIOLOGICAL E LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00515/AM17/ RLA File :09/24/040/00007/AM17/ Lic.No/Date:0910063629 17.05.2016 Defer Date:22.03.2017 247

Case No.:94/10/82-ALC4/2016 Party Name:KLJ

Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00440/AM17/ RLA File :05/23/040/00067/AM17/ Lic.No/Date:0510398541 18.05.2016 Defer Date: decision taken by NC in its meeting No.04/82 dated 16.05.2013, uploaded at the end of 248

Case No.:126/10/82-

ALC4/2016 Party Name:BIOLOGICAL E LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00472/AM17/ RLA File :09/24/040/00306/AM15/ Lic.No/Date:0910063657 19.05.2016 Defer Date:22.03.2017 249

Case No.:149/10/82-

ALC4/2016 Party Name:BIOLOGICAL E LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00495/AM17/ RLA File :09/24/040/00546/AM16/ Lic.No/Date:0910063659 19.05.2016 Defer Date:22.03.2017 250 Case No.:72/10/82- Party Name:V.D.H. Meet No/Date:18/82- Status:

41 ALC4/2016 ORGANICS PVT. LTD ALC4/2016 15.02.2017 Deferred HQ File :01/82/050/00418/AM17/ RLA File :05/24/040/00080/AM17/ Lic.No/Date:0510398561 19.05.2016 Defer Date:22.03.2017 Decision :Deferred. 251

Case No.:73/10/82-

ALC4/2016 Party Name:VDH CHEM TECH PVT. LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00419/AM17/ RLA File :05/24/040/00067/AM17/ Lic.No/Date:0510398560 19.05.2016 Defer Date:22.03.2017 Decision :Deferred. 252

Case No.:156/7/82-

ALC4/2016 Party Name:AMINES & Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00330/AM17/ RLA File :03/94/040/00147/AM17/ Lic.No/Date:0310804903 23.05.2016 Defer Date:22.03.2017 Decision :Deferred. 253

Case No.:130/10/82-

ALC4/2016 Party Name:SRINI PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: approved HQ File :01/82/050/00476/AM17/ RLA File :09/24/040/00078/AM17/ Lic.No/Date:0910063664 23.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/464/2013-PI(Norms) dated June 2015, uploaded 254

Case No.:83/10/82-

ALC4/2016 Party Name:STERILE INDIA PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00429/AM17/ RLA File :05/24/040/00633/AM16/ Lic.No/Date:0510398574 23.05.2016 Defer Date:22.03.2017 Decision :Deferred. 255

Case No.:79/10/82-

ALC4/2016 KABI ONCOLOGY LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00425/AM17/ RLA File :05/23/040/00075/AM17/ Lic.No/Date:0510398581 24.05.2016 Defer Date:22.03.2017 256

Case No.:74/10/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File RLA File Lic.No/Date:0510398583 Defer

42 :01/82/050/00420/AM17/ :05/23/040/00078/AM17/ 24.05.2016 Date:22.03.2017 Decision : 257

Case No.:75/10/82-ALC4/2016 Party Name:JUBILANT

GENERICS LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00421/AM17/ RLA File :05/23/040/00076/AM17/ Lic.No/Date:0510398582 24.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/815/2013-PI(Norms) dated August 2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 258

Case No.:185/10/82-

ALC4/2016 Party Name:PAUSHAK LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00531/AM17/ RLA File :34/24/040/00037/AM17/ Lic.No/Date:3410042207 25.05.2016 Defer Date:22.03.2017 259

Case No.:87/10/82-ALC4/2016 Party Name:SENTISS

PHARMA PVT.LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: approved HQ File :01/82/050/00433/AM17/ RLA File :05/24/040/00058/AM17/ Lic.No/Date:0510398614 25.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/634/2012-PI(Norms) dated 12.03.2013, uploaded 260

Case No.:102/10/82-

ALC4/2016 Party Name:IKRISH HEALTHCARE PVT.LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00448/AM17/ RLA File :05/23/040/00091/AM17/ Lic.No/Date:0510398628 26.05.2016 Defer Date:22.03.2017 261

Case No.:68/10/82-

ALC4/2016 PVT.LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00414/AM17/ RLA File :05/23/040/00088/AM17/ Lic.No/Date:0510398631 26.05.2016 Defer Date:22.03.2017 262

Case No.:65/10/82-

ALC4/2016 Party Name:KORES (INDIA) LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00411/AM17/ RLA File :31/83/040/00014/AM17/ Lic.No/Date:3110066163 26.05.2016 Defer Date:22.03.2017

43 263

Case No.:88/10/82-

ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00434/AM17/ RLA File :05/24/040/00083/AM17/ Lic.No/Date:0510398625 26.05.2016 Defer Date:22.03.2017 264

Case No.:117/10/82-

ALC4/2016 Party Name:DR. REDDYS Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00463/AM17/ RLA File :09/24/040/00089/AM17/ Lic.No/Date:0910063705 27.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/44/2016-PI(Norms) dated August 2016, uploaded 265

Case No.:112/10/82-

ALC4/2016 KABI ONCOLOGY LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00458/AM17/ RLA File :05/23/040/00094/AM17/ Lic.No/Date:0510398655 27.05.2016 Defer Date:22.03.2017 266

Case No.:142/16/82-

ALC4/2016 Party Name:ENCEE AROMATICS PVT. LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00959/AM17/ RLA File :32/21/040/00021/AM17/ Lic.No/Date:3210077902 30.05.2016 Defer Date:22.03.2017 267

Case No.:36/10/82-

ALC4/2016 KABI INDIA PRIVATE LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00382/AM17/ RLA File :03/94/040/00145/AM17/ Lic.No/Date:0310805018 30.05.2016 Defer Date:22.03.2017 268

Case No.:34/10/82-ALC4/2016 Party Name:KAIRAV

CHEMOFARBE INDUSTRIES LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00380/AM17/ RLA File :03/94/040/00048/AM17/ Lic.No/Date:0310805010 30.05.2016 Defer Date: decision taken by NC in its meeting No.11/82 dated 05.09.2013, uploaded at the end of

44 269

Case No.:35/10/82-

ALC4/2016 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00381/AM17/ RLA File :03/94/040/00030/AM17/ Lic.No/Date:0310805009 30.05.2016 Defer Date:22.03.2017 270

Case No.:123/10/82-

ALC4/2016 Party Name:NIFTY LABS PVT LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00469/AM17/ RLA File :09/24/040/00102/AM17/ Lic.No/Date:0910063716 30.05.2016 Defer Date:22.03.2017 271

Case No.:103/10/82-

ALC4/2016 Party Name:AGSON GLOBAL PRIVATE LIMITED. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00449/AM17/ RLA File :05/23/040/00095/AM17/ Lic.No/Date:0510398680 31.05.2016 Defer Date:22.03.2017 272

Case No.:97/10/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00443/AM17/ RLA File :05/24/040/00066/AM17/ Lic.No/Date:0510398693 31.05.2016 Defer Date:22.03.2017 273

Case No.:187/10/82-

ALC4/2016 Party Name:WINDLAS HEALTH CARE PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00533/AM17/ RLA File :61/24/040/00001/AM17/ Lic.No/Date:6110001350 01.06.2016 Defer Date:22.03.2017 274

Case No.:54/10/82-ALC4/2016 Party Name:MALLADI

DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00400/AM17/ RLA File :04/24/040/00038/AM17/ Lic.No/Date:0410162004 02.06.2016 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/255/2015-PI(Norms) dated Navember 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.

45 275

Case No.:69/10/82-

ALC4/2016 PVT.LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00415/AM17/ RLA File :05/23/040/00108/AM17/ Lic.No/Date:0510398724 03.06.2016 Defer Date:22.03.2017 276

Case No.:70/10/82-

ALC4/2016 PVT.LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00416/AM17/ RLA File :05/23/040/00109/AM17/ Lic.No/Date:0510398725 03.06.2016 Defer Date:22.03.2017 277

Case No.:48/10/82-ALC4/2016 Party Name:AGIO

PHARMACEUTICALS LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00394/AM17/ RLA File :03/94/040/00051/AM17/ Lic.No/Date:0310805268 07.06.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/700/2013-PI(Norms) dated 01.04.2014, uploaded 278

Case No.:50/10/82-ALC4/2016 Party Name:AGIO

PHARMACEUTICALS LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00396/AM17/ RLA File :03/94/040/00065/AM17/ Lic.No/Date:0310805269 07.06.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/700/2013-PI(Norms) dated 01.04.2014, uploaded 279

Case No.:51/10/82-

ALC4/2016 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00397/AM17/ RLA File :03/94/040/00196/AM17/ Lic.No/Date:0310805264 07.06.2016 Defer Date:22.03.2017 280

Case No.:11/10/82-

ALC4/2016 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00357/AM17/ RLA File :08/24/040/00088/AM17/ Lic.No/Date:0810138109 07.06.2016 Defer Date:22.03.2017

46 281

Case No.:129/10/82-

ALC4/2016 Party Name:MYLAN Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00475/AM17/ RLA File :09/24/040/00045/AM17/ Lic.No/Date:0910063759 07.06.2016 Defer Date:22.03.2017 282

Case No.:134/10/82-

ALC4/2016 Party Name:ALPHAMED FORMULATIONS P LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00480/AM17/ RLA File :09/24/040/00087/AM17/ Lic.No/Date:0910063771 08.06.2016 Defer Date:22.03.2017 283

Case No.:18/10/82-ALC4/2016 Party Name:ARJUN

CHEMICALS PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00364/AM17/ RLA File :04/24/040/00041/AM17/ Lic.No/Date:0410162023 08.06.2016 Defer Date: decision taken by NC in its meeting No.1/82 dated 04.04.2013, uploaded at the end of 284

Case No.:121/10/82-

ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00467/AM17/ RLA File :09/24/040/00032/AM17/ Lic.No/Date:0910063765 08.06.2016 Defer Date:22.03.2017 285

Case No.:151/10/82-

ALC4/2016 Party Name:INCHEM LABORATORIES PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00497/AM17/ RLA File :09/24/040/00123/AM17/ Lic.No/Date:0910063778 09.06.2016 Defer Date:22.03.2017 286

Case No.:49/10/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00395/AM17/ RLA File :03/94/040/00181/AM17/ Lic.No/Date:0310805345 09.06.2016 Defer Date:22.03.2017 287 Case No.:179/10/82- ALC4/2016 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:18/82- ALC4/2016 Status: Approved

47 15.02.2017 HQ File :01/82/050/00525/AM17/ RLA File :34/24/040/00064/AM17/ Lic.No/Date:3410042257 10.06.2016 Defer Date: decision taken by NC in its meeting No.26/82 dated 27.09.2011, uploaded at the end of 288

Case No.:12/10/82-

ALC4/2016 Party Name:CAPLIN POINT LABORATORIES LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00358/AM17/ RLA File :04/24/040/00043/AM17/ Lic.No/Date:0410162034 10.06.2016 Defer Date:22.03.2017 289

Case No.:46/10/82-ALC4/2016 Party Name:NOCIL LIMITED

Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00392/AM17/ RLA File :03/95/040/00134/AM17/ Lic.No/Date:0310805363 10.06.2016 Defer Date: decision taken by NC in its meeting No.01/82 dated 10.04.2014, uploaded at the end of 290

Case No.:47/10/82-ALC4/2016 Party Name:SUNSHIELD

CHEMICALS LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00393/AM17/ RLA File :03/95/040/00196/AM17/ Lic.No/Date:0310805364 10.06.2016 Defer Date: decision taken by NC in its meeting No.28/82 dated 11.10.2011, uploaded at the end of 291

Case No.:64/10/82-

ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00410/AM17/ RLA File :31/83/040/00195/AM16/ Lic.No/Date:3110066174 13.06.2016 Defer Date:22.03.2017 292

Case No.:14/10/82-

ALC4/2016 Party Name:CAPLIN POINT LABORATORIES LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00360/AM17/ RLA File :04/24/040/00049/AM17/ Lic.No/Date:0410162041 14.06.2016 Defer Date:22.03.2017

48 293

Case No.:52/10/82-

ALC4/2016 Party Name:CLARIANT INDIA LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00398/AM17/ RLA File :03/94/040/00223/AM17/ Lic.No/Date:0310805476 14.06.2016 Defer Date:22.03.2017 294

Case No.:26/10/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00372/AM17/ RLA File :03/94/040/00217/AM17/ Lic.No/Date:0310805452 14.06.2016 Defer Date:22.03.2017 295

Case No.:27/10/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00373/AM17/ RLA File :03/94/040/00218/AM17/ Lic.No/Date:0310805451 14.06.2016 Defer Date:22.03.2017 296

Case No.:137/10/82-

ALC4/2016 Party Name:PROCESS AGROCHEM INDUSTRIES PVT. LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00483/AM17/ RLA File :56/24/040/00009/AM17/ Lic.No/Date:5610004930 14.06.2016 Defer Date:22.03.2017 297

Case No.:19/10/82-

ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00365/AM17/ RLA File :05/24/040/00117/AM17/ Lic.No/Date:0510398800 14.06.2016 Defer Date:22.03.2017 298

Case No.:60/10/82-ALC4/2016 Party Name:VENUS

REMEDIES LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00406/AM17/ RLA File :22/24/040/00014/AM17/ Lic.No/Date:2210015501 14.06.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/767/2015-PI(Norms) dated June 2016, uploaded

49 299

Case No.:61/10/82-

ALC4/2016 Party Name:ANUJA HEALTHCARE LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00407/AM17/ RLA File :22/24/040/00013/AM17/ Lic.No/Date:2210015504 15.06.2016 Defer Date:22.03.2017 300

Case No.:25/10/82-

ALC4/2016 Party Name:ASTEC LIFESCIENCES LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00371/AM17/ RLA File :03/94/040/00132/AM17/ Lic.No/Date:0310805494 15.06.2016 Defer Date:22.03.2017 301

Case No.:154/10/82-

ALC4/2016 Party Name:MYLAN Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00500/AM17/ RLA File :09/24/040/00084/AM17/ Lic.No/Date:0910063799 15.06.2016 Defer Date:22.03.2017 302

Case No.:23/10/82-

ALC4/2016 Party Name:RECKITT BENCKISER ( INDIA) PRIVATE LIMITED, Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00369/AM17/ RLA File :05/24/040/00128/AM17/ Lic.No/Date:0510398826 16.06.2016 Defer Date:22.03.2017 303

Case No.:62/10/82-

ALC4/2016 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00408/AM17/ RLA File :52/24/040/00019/AM17/ Lic.No/Date:5210041935 17.06.2016 Defer Date:22.03.2017 304

Case No.:57/10/82-

ALC4/2016 SCIENCES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00403/AM17/ RLA File :05/23/040/00054/AM17/ Lic.No/Date:0510398839 17.06.2016 Defer Date:22.03.2017 305

Case No.:40/10/82-

ALC4/2016 Party Name:UNIMAX LABORATORIES PVT.LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00386/AM17/ RLA File :03/95/040/00191/AM17/ Lic.No/Date:0310805570 17.06.2016 Defer Date:22.03.2017

50 306

Case No.:58/10/82-

ALC4/2016 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00404/AM17/ RLA File :52/24/040/00018/AM17/ Lic.No/Date:5210041937 20.06.2016 Defer Date:22.03.2017 307

Case No.:30/10/82-ALC4/2016 Party Name:DANOPHARM

CHEMICALS PRIVATE LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00376/AM17/ RLA File :03/94/040/00150/AM17/ Lic.No/Date:0310805606 20.06.2016 Defer Date: decision taken by NC in its meeting No.07/82 dated 24.07.2015, uploaded at the end of 308

Case No.:29/10/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00375/AM17/ RLA File :03/94/040/00208/AM17/ Lic.No/Date:0310805623 21.06.2016 Defer Date:22.03.2017 309

Case No.:33/16/82-

ALC4/2016 Party Name:SHREE JAYA LABORATORIES PVT LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00850/AM17/ RLA File :09/24/040/00128/AM17/ Lic.No/Date:0910063810 21.06.2016 Defer Date:22.03.2017 310

Case No.:78/10/82-

ALC4/2016 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00424/AM17/ RLA File :13/24/040/00009/AM17/ Lic.No/Date:1310048295 22.06.2016 Defer Date:22.03.2017 311

Case No.:56/10/82-

ALC4/2016 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00402/AM17/ RLA File :04/24/040/00051/AM17/ Lic.No/Date:0410162058 22.06.2016 Defer Date:22.03.2017 recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/255/2016-PI(Norms) dated November 2016, uploaded at the end of these minutes and deferred the case.

51 312

Case No.:105/10/82-

ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00451/AM17/ RLA File :05/24/040/00133/AM17/ Lic.No/Date:0510398872 22.06.2016 Defer Date:22.03.2017 recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/253/2016-PI(Norms) dated October 2016, uploaded at the end of these minutes and deferred the case. 313

Case No.:35/16/82-

ALC4/2016 Party Name:SHREE JAYA LABORATORIES PVT LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00852/AM17/ RLA File :09/24/040/00154/AM17/ Lic.No/Date:0910063814 22.06.2016 Defer Date:22.03.2017 314

Case No.:81/16/82-

ALC4/2016 Party Name:VISION DRUGS PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00898/AM17/ RLA File :09/24/040/00131/AM17/ Lic.No/Date:0910063815 22.06.2016 Defer Date:22.03.2017 315

Case No.:83/16/82-

ALC4/2016 LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00900/AM17/ RLA File :09/24/040/00101/AM17/ Lic.No/Date:0910063816 22.06.2016 Defer Date:22.03.2017 316

Case No.:58/16/82-ALC4/2016 Party Name:DISTO

PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00875/AM17/ RLA File :09/24/040/00152/AM17/ Lic.No/Date:0910063836 23.06.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/795/2015-PI(Norms) dated 25.07.2016, uploaded 317

Case No.:109/10/82-

ALC4/2016 Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00455/AM17/ RLA File :22/24/040/00022/AM17/ Lic.No/Date:2210015511 23.06.2016 Defer Date:22.03.2017

52 318

Case No.:40/16/82-ALC4/2016 Party Name:OPTIMUS

DRUGS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00857/AM17/ RLA File :09/24/040/00166/AM17/ Lic.No/Date:0910063840 24.06.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/820/2015-PI(Norms) dated 12.05.2016, uploaded 319

Case No.:38/10/82-

ALC4/2016 Party Name:ORBIT LIFE SCIENCE PVT. LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00384/AM17/ RLA File :03/95/040/00234/AM17/ Lic.No/Date:0310805748 28.06.2016 Defer Date:22.03.2017 320

Case No.:39/10/82-

ALC4/2016 Party Name:ORBIT LIFE SCIENCE PVT. LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00385/AM17/ RLA File :03/95/040/00235/AM17/ Lic.No/Date:0310805747 28.06.2016 Defer Date:22.03.2017 321

Case No.:61/16/82-

ALC4/2016 LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00878/AM17/ RLA File :09/24/040/00145/AM17/ Lic.No/Date:0910063847 28.06.2016 Defer Date:22.03.2017 322

Case No.:92/16/82-

ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00909/AM17/ RLA File :09/24/040/00157/AM17/ Lic.No/Date:0910063873 30.06.2016 Defer Date:22.03.2017 323

Case No.:138/10/82-

ALC4/2016 Party Name:PARENTRAL DRUGS INDIA LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00484/AM17/ RLA File :56/24/040/00051/AM16/ Lic.No/Date:5610004939 30.06.2016 Defer Date:22.03.2017 324

Case No.:56/16/82-

ALC4/2016 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred

53 HQ File :01/82/050/00873/AM17/ RLA File :09/24/040/00150/AM17/ Lic.No/Date:0910063877 30.06.2016 Defer Date:22.03.2017 Decision :Deferred. 325

Case No.:182/10/82-

ALC4/2016 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00528/AM17/ RLA File :34/24/040/00095/AM17/ Lic.No/Date:3410042315 30.06.2016 Defer Date:22.03.2017 Decision :Deferred. 326

Case No.:183/10/82-

ALC4/2016 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00529/AM17/ RLA File :34/24/040/00094/AM17/ Lic.No/Date:3410042314 30.06.2016 Defer Date:22.03.2017 Decision :Deferred. 327

Case No.:47/16/82-ALC4/2016 Party Name:DEEPAK

NITRITE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00864/AM17/ RLA File :34/24/040/00298/AM16/ Lic.No/Date:3410042323 01.07.2016 Defer Date: decision taken by NC in its meeting No.28/82 dated 11.10.2011, uploaded at the end of 328

Case No.:30/16/82-ALC4/2016 Party Name:SRINI

PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00847/AM17/ RLA File :09/24/040/00164/AM17/ Lic.No/Date:0910063878 01.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/87/2015-PI(Norms) dated September 2015, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 329

Case No.:57/16/82-ALC4/2016 Party Name:AUROBINDO

PHARMA LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00874/AM17/ RLA File :09/24/040/00025/AM17/ Lic.No/Date:0910063886 04.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/328/2015-PI(Norms) dated 24.06.2013, uploaded

54 330

Case No.:85/10/82-

ALC4/2016 SCIENCES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00431/AM17/ RLA File :05/23/040/00172/AM17/ Lic.No/Date:0510398972 04.07.2016 Defer Date:22.03.2017 Decision :Deferred. 331

Case No.:86/10/82-

ALC4/2016 SCIENCES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00432/AM17/ RLA File :05/23/040/00146/AM17/ Lic.No/Date:0510398970 04.07.2016 Defer Date:22.03.2017 332

Case No.:101/10/82-

ALC4/2016 SCIENCES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00447/AM17/ RLA File :05/23/040/00173/AM17/ Lic.No/Date:0510398971 04.07.2016 Defer Date:22.03.2017 333

Case No.:135/10/82-

ALC4/2016 Party Name:PARENTRAL DRUGS INDIA LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00481/AM17/ RLA File :56/24/040/00014/AM17/ Lic.No/Date:5610004941 04.07.2016 Defer Date:22.03.2017 334

Case No.:3/8/82-ALC4/2016

Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00341/AM17/ RLA File :34/24/040/00079/AM17/ Lic.No/Date:3410042326 05.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/473/2014-PI(Norms) dated March 2015, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 335

Case No.:5/14/82-ALC4/2016 Party Name:ASTRAL

STERITECH PVT. LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00803/AM17/ RLA File :34/24/040/00099/AM17/ Lic.No/Date:3410042324 05.07.2016 Defer Date:22.03.2017 336

Case No.:2/16/82-ALC4/2016 Party Name:ASTRAL

STERITECH PVT. LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred

55 HQ File :01/82/050/00819/AM17/ RLA File :34/24/040/00100/AM17/ Lic.No/Date:3410042325 05.07.2016 Defer Date:22.03.2017 337

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

Party Name:HELLO PAINTS (P) LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00340/AM17/ RLA File :05/23/040/00139/AM17/ Lic.No/Date:0510398996 05.07.2016 Defer Date: decision taken by NC in its meeting No.35/82 dated 29.11.2011, uploaded at the end of 338

Case No.:63/16/82-

ALC4/2016 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00880/AM17/ RLA File :09/24/040/00178/AM17/ Lic.No/Date:0910063892 06.07.2016 Defer Date:22.03.2017 339

Case No.:48/16/82-ALC4/2016 Party Name:DEEPAK

NITRITE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00865/AM17/ RLA File :34/24/040/00295/AM16/ Lic.No/Date:3410042327 07.07.2016 Defer Date: Decision :The Committee decided to ratify norm on repeat basis based on the earlier decision taken by NC in its meeting No.28/82 dated 11.10.2011, uploaded at the end of 340

Case No.:4/8/82-ALC4/2016

Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00342/AM17/ RLA File :08/24/040/00132/AM17/ Lic.No/Date:0810138237 07.07.2016 Defer Date:22.03.2017 341

Case No.:63/10/82-

ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00409/AM17/ RLA File :04/24/040/00058/AM17/ Lic.No/Date:0410162083 08.07.2016 Defer Date:22.03.2017 342

Case No.:82/16/82-

ALC4/2016 Party Name:EYTAN LABS LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred

56 HQ File :01/82/050/00899/AM17/ RLA File :09/24/040/00162/AM17/ Lic.No/Date:0910063899 11.07.2016 Defer Date:22.03.2017 343

Case No.:10/14/82-

ALC4/2016 Party Name:GLOBAL MEDICINES LTD, Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00808/AM17/ RLA File :34/24/040/00101/AM17/ Lic.No/Date:3410042344 12.07.2016 Defer Date:22.03.2017 344

Case No.:36/16/82-

ALC4/2016 Party Name:NATCO PHARMA LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00853/AM17/ RLA File :09/24/040/00169/AM17/ Lic.No/Date:0910063915 13.07.2016 Defer Date:22.03.2017 345

Case No.:39/16/82-

ALC4/2016 Party Name:NATCO PHARMA LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00856/AM17/ RLA File :09/24/040/00168/AM17/ Lic.No/Date:0910063916 13.07.2016 Defer Date:22.03.2017 346

Case No.:41/16/82-

ALC4/2016 Party Name:NATCO PHARMA LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00858/AM17/ RLA File :09/24/040/00167/AM17/ Lic.No/Date:0910063917 13.07.2016 Defer Date:22.03.2017 347

Case No.:42/16/82-

ALC4/2016 Party Name:NIFTY LABS PVT LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00859/AM17/ RLA File :09/24/040/00206/AM17/ Lic.No/Date:0910063914 13.07.2016 Defer Date:22.03.2017 348

Case No.:106/16/82-

ALC4/2016 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00923/AM17/ RLA File :09/24/040/00175/AM17/ Lic.No/Date:0910063913 13.07.2016 Defer Date:22.03.2017 349 Case No.:29/16/82- Party Name:AUROBINDO Meet No/Date:18/82- Status:

57 ALC4/2016 PHARMA LIMITED ALC4/2016 15.02.2017 Deferred HQ File :01/82/050/00846/AM17/ RLA File :09/24/040/00180/AM17/ Lic.No/Date:0910063923 14.07.2016 Defer Date:22.03.2017 350

Case No.:103/16/82-

ALC4/2016 PHARMA LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00920/AM17/ RLA File :09/24/040/00174/AM17/ Lic.No/Date:0910063926 14.07.2016 Defer Date:22.03.2017 351

Case No.:105/16/82-

ALC4/2016 PHARMA LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00922/AM17/ RLA File :09/24/040/00170/AM17/ Lic.No/Date:0910063925 14.07.2016 Defer Date:22.03.2017 352

Case No.:82/10/82-

ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00428/AM17/ RLA File :31/83/040/00041/AM17/ Lic.No/Date:3110066246 14.07.2016 Defer Date:22.03.2017 353

Case No.:84/16/82-

ALC4/2016 Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00901/AM17/ RLA File :09/24/040/00224/AM17/ Lic.No/Date:0910063921 14.07.2016 Defer Date:22.03.2017 354

Case No.:37/16/82-

ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00854/AM17/ RLA File :09/24/040/00214/AM17/ Lic.No/Date:0910063939 15.07.2016 Defer Date:22.03.2017 355

Case No.:43/16/82-

ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00860/AM17/ RLA File :09/24/040/00213/AM17/ Lic.No/Date:0910063938 15.07.2016 Defer Date:22.03.2017

58 356

Case No.:6/8/82-ALC4/2016

Party Name:ATUL LIMITED, Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00344/AM17/ RLA File :08/24/040/00134/AM17/ Lic.No/Date:0810138308 18.07.2016 Defer Date: decision taken by NC in its meeting No.08/82 dated 25.09.2014, uploaded at the end of 357

Case No.:16/16/82-

ALC4/2016 PHARMA LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00833/AM17/ RLA File :09/24/040/00217/AM17/ Lic.No/Date:0910063946 19.07.2016 Defer Date:22.03.2017 358

Case No.:32/16/82-

ALC4/2016 PHARMA LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00849/AM17/ RLA File :09/24/040/00218/AM17/ Lic.No/Date:0910063947 19.07.2016 Defer Date:22.03.2017 359

Case No.:4/14/82-ALC4/2016 Party Name:BEST VALUE

CHEM PVT. LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00802/AM17/ RLA File :34/24/040/00109/AM17/ Lic.No/Date:3410042360 19.07.2016 Defer Date:22.03.2017 Decision :Deferred. 360

Case No.:34/16/82-

ALC4/2016 LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00851/AM17/ RLA File :09/24/040/00199/AM17/ Lic.No/Date:0910063950 20.07.2016 Defer Date:22.03.2017 Decision :Deferred. 361

Case No.:27/16/82-

ALC4/2016 Party Name:BRILLIANT BIO PHARMA PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00844/AM17/ RLA File :09/24/040/00132/AM17/ Lic.No/Date:0910063967 21.07.2016 Defer Date:22.03.2017 362 Case No.:3/14/82-ALC4/2016 Party Name:TRANSPEK INDUSTRY LIMITED Meet No/Date:18/82- ALC4/2016 Status: Deferred

59 15.02.2017 HQ File :01/82/050/00801/AM17/ RLA File :34/24/040/00124/AM17/ Lic.No/Date:3410042372 22.07.2016 Defer Date:22.03.2017 363

Case No.:60/16/82-

ALC4/2016 Party Name:OPTRIX LABORATORIES PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00877/AM17/ RLA File :09/24/040/00235/AM17/ Lic.No/Date:0910063977 25.07.2016 Defer Date:22.03.2017 364

Case No.:49/16/82-

ALC4/2016 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00866/AM17/ RLA File :34/24/040/00127/AM17/ Lic.No/Date:3410042385 27.07.2016 Defer Date:22.03.2017 365

Case No.:85/16/82-

ALC4/2016 Party Name:OPTRIX LABORATORIES PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00902/AM17/ RLA File :09/24/040/00234/AM17/ Lic.No/Date:0910063995 28.07.2016 Defer Date:22.03.2017 366

Case No.:31/16/82-

ALC4/2016 Party Name:OPTRIX LABORATORIES PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00848/AM17/ RLA File :09/24/040/00236/AM17/ Lic.No/Date:0910063999 29.07.2016 Defer Date:22.03.2017 367

Case No.:24/16/82-

ALC4/2016 Party Name:SRINI PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00841/AM17/ RLA File :09/24/040/00243/AM17/ Lic.No/Date:0910064002 02.08.2016 Defer Date:22.03.2017 368

Case No.:9/14/82-ALC4/2016 Party Name:ALEMBIC

PHARMACEUTICALS LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00807/AM17/ RLA File :34/24/040/00133/AM17/ Lic.No/Date:3410042403 04.08.2016 Defer Date:22.03.2017

60 369

Case No.:25/16/82-

ALC4/2016 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00842/AM17/ RLA File :09/24/040/00248/AM17/ Lic.No/Date:0910064009 04.08.2016 Defer Date:22.03.2017 Decision :Deferred. 370

Case No.:21/16/82-

ALC4/2016 Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00838/AM17/ RLA File :09/24/040/00151/AM17/ Lic.No/Date:0910064013 08.08.2016 Defer Date:22.03.2017 371

Case No.:139/16/82-

ALC4/2016 Party Name:ARJUN CHEMICALS PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00956/AM17/ RLA File :04/24/040/00080/AM17/ Lic.No/Date:0410162170 08.08.2016 Defer Date:22.03.2017 Decision :Deferred. 372

Case No.:23/16/82-

ALC4/2016 Party Name:MYLAN Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00840/AM17/ RLA File :09/24/040/00210/AM17/ Lic.No/Date:0910064015 09.08.2016 Defer Date:22.03.2017 373

Case No.:14/16/82-

ALC4/2016 Party Name:DR. REDDYS Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00831/AM17/ RLA File :09/24/040/00229/AM17/ Lic.No/Date:0910064024 11.08.2016 Defer Date:22.03.2017 374

Case No.:22/16/82-

ALC4/2016 LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00839/AM17/ RLA File :09/24/040/00211/AM17/ Lic.No/Date:0910064039 16.08.2016 Defer Date:22.03.2017 Decision :Deferred. 375

Case No.:13/16/82-

ALC4/2016 Party Name:NIFTY LABS PVT LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00830/AM17/ RLA File :09/24/040/00261/AM17/ Lic.No/Date:0910064050 17.08.2016 Defer Date:22.03.2017

61 376

Case No.:9/16/82-ALC4/2016 Party Name:ALEMBIC

PHARMACEUTICALS LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00826/AM17/ RLA File :34/24/040/00146/AM17/ Lic.No/Date:3410042456 19.08.2016 Defer Date:22.03.2017 377

Case No.:15/16/82-

ALC4/2016 Party Name:GRANULES INDIA LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00832/AM17/ RLA File :09/24/040/00264/AM17/ Lic.No/Date:0910064057 19.08.2016 Defer Date:22.03.2017 378

Case No.:1/16/82-ALC4/2016

Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00818/AM17/ RLA File :05/24/040/00202/AM17/ Lic.No/Date:0510399511 19.08.2016 Defer Date: Decision : The Committee decided to ratify norms based on SION A-3647 published vide PN No.64 dated 17.03.2016 or as applied by the firm whichever is less. RA concerned may take further necessary action as per decision of NC. 379

Case No.:46/16/82-

ALC4/2016 PHARMA LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00863/AM17/ RLA File :09/24/040/00276/AM17/ Lic.No/Date:0910064077 26.08.2016 Defer Date:22.03.2017 380

Case No.:140/16/82-

ALC4/2016 Party Name:NUTRA SPECIALITIES PVT. LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00957/AM17/ RLA File :04/24/040/00265/AM16/ Lic.No/Date:0410162242 02.09.2016 Defer Date:22.03.2017 381

Case No.:100/16/82-

ALC4/2016 Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00917/AM17/ RLA File :05/23/040/00272/AM17/ Lic.No/Date:0510399660 08.09.2016 Defer Date:22.03.2017 382

Case No.:3/12/82-ALC4/2016 Party Name:SENTISS

PHARMA PVT.LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred

62 HQ File :01/82/050/00627/AM17/ RLA File :05/24/040/00255/AM17/ Lic.No/Date:0510399725 15.09.2016 Defer Date:22.03.2017 383

Case No.:4/12/82-ALC4/2016

PHARMA LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00628/AM17/ RLA File :09/24/040/00290/AM17/ Lic.No/Date:0910064145 16.09.2016 Defer Date: Decision : The Committee decided to ratify norms based on SION A-3672 published vide PN No.64 dated 17.03.2016 or as applied by the firm whichever is less. RA concerned may take further necessary action as per decision of NC. 384

Case No.:90/16/82-

ALC4/2016 Party Name:MAHIMA LIFE SCIENCES PVT.LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00907/AM17/ RLA File :05/24/040/00229/AM17/ Lic.No/Date:0510399749 16.09.2016 Defer Date:22.03.2017 385

Case No.:91/16/82-

ALC4/2016 SCIENCES PVT.LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00908/AM17/ RLA File :05/24/040/00216/AM17/ Lic.No/Date:0510399740 16.09.2016 Defer Date:22.03.2017 386

Case No.:94/16/82-

ALC4/2016 SCIENCES PVT.LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00911/AM17/ RLA File :05/24/040/00230/AM17/ Lic.No/Date:0510399750 16.09.2016 Defer Date:22.03.2017 387

Case No.:95/16/82-

ALC4/2016 SCIENCES PVT.LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00912/AM17/ RLA File :05/24/040/00222/AM17/ Lic.No/Date:0510399746 16.09.2016 Defer Date:22.03.2017 388

Case No.:96/16/82-

ALC4/2016 SCIENCES PVT.LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00913/AM17/ RLA File :05/24/040/00223/AM17/ Lic.No/Date:0510399747 16.09.2016 Defer Date:22.03.2017

63 389

Case No.:97/16/82-

ALC4/2016 SCIENCES PVT.LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00914/AM17/ RLA File :05/24/040/00261/AM17/ Lic.No/Date:0510399752 16.09.2016 Defer Date:22.03.2017 390

Case No.:110/16/82-

ALC4/2016 SCIENCES PVT.LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00927/AM17/ RLA File :05/24/040/00207/AM17/ Lic.No/Date:0510399738 16.09.2016 Defer Date:22.03.2017 391

Case No.:119/16/82-

ALC4/2016 SCIENCES PVT.LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00936/AM17/ RLA File :05/24/040/00220/AM17/ Lic.No/Date:0510399742 16.09.2016 Defer Date:22.03.2017 392

Case No.:6/16/82-ALC4/2016 Party Name:DIVIS

LABORATORIES LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00823/AM17/ RLA File :09/24/040/00327/AM17/ Lic.No/Date:0910064153 19.09.2016 Defer Date:22.03.2017 393

Case No.:99/16/82-

ALC4/2016 Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00916/AM17/ RLA File :05/23/040/00280/AM17/ Lic.No/Date:0510399773 20.09.2016 Defer Date:22.03.2017 Decision :Deferred. 394

Case No.:70/16/82-

ALC4/2016 Party Name:INDO PHYTO CHEMICALS PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00887/AM17/ RLA File :05/23/040/00237/AM17/ Lic.No/Date:0510399777 20.09.2016 Defer Date:22.03.2017 395

Case No.:76/16/82-

ALC4/2016 Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred

64 HQ File :01/82/050/00893/AM17/ RLA File :05/23/040/00162/AM17/ Lic.No/Date:0510399799 21.09.2016 Defer Date:22.03.2017 Decision :Deferred. 396

Case No.:112/16/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00929/AM17/ RLA File :05/24/040/00282/AM17/ Lic.No/Date:0510399789 21.09.2016 Defer Date:22.03.2017 397

Case No.:72/16/82-

ALC4/2016 Party Name:ASIATIC DRUGS &PHARMACEUTICALS PVT. LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00889/AM17/ RLA File :05/23/040/00214/AM17/ Lic.No/Date:0510399816 22.09.2016 Defer Date:22.03.2017 398

Case No.:6/14/82-ALC4/2016 Party Name:SWATI

MENTHOL & ALLIED CHEMICALS LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00804/AM17/ RLA File :29/24/040/00002/AM17/ Lic.No/Date:2910025262 23.09.2016 Defer Date:22.03.2017 Decision :Deferred. 399

Case No.:93/16/82-

ALC4/2016 SOLVENTS LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00910/AM17/ RLA File :05/24/040/00301/AM17/ Lic.No/Date:0510399916 27.09.2016 Defer Date:22.03.2017 Decision :Deferred. 400

Case No.:78/16/82-

ALC4/2016 Party Name:KLJ Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00895/AM17/ RLA File :05/23/040/00304/AM17/ Lic.No/Date:0510399927 28.09.2016 Defer Date:22.03.2017 Decision :Deferred. 401

Case No.:109/16/82-

ALC4/2016 Party Name:PANERA BIOTEC PVT.LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00926/AM17/ RLA File :05/24/040/00307/AM17/ Lic.No/Date:0510399924 28.09.2016 Defer Date:22.03.2017 Decision : Deferred for want of comments from DBT.

65 402

Case No.:128/16/82-

ALC4/2016 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00945/AM17/ RLA File :08/24/040/00260/AM17/ Lic.No/Date:0810138777 30.09.2016 Defer Date:22.03.2017 403

Case No.:124/16/82-

ALC4/2016 Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00941/AM17/ RLA File :08/24/040/00256/AM17/ Lic.No/Date:0810138780 30.09.2016 Defer Date:22.03.2017 404

Case No.:125/16/82-

ALC4/2016 Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00942/AM17/ RLA File :08/24/040/00255/AM17/ Lic.No/Date:0810138776 30.09.2016 Defer Date:22.03.2017 405

Case No.:69/16/82-

ALC4/2016 Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00886/AM17/ RLA File :05/23/040/00310/AM17/ Lic.No/Date:0510399960 03.10.2016 Defer Date:22.03.2017 406

Case No.:77/16/82-

ALC4/2016 SCIENCES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00894/AM17/ RLA File :05/23/040/00188/AM17/ Lic.No/Date:0510399958 03.10.2016 Defer Date:22.03.2017 Decision :Deferred. 407

Case No.:98/16/82-

ALC4/2016 Party Name:INDO PHYTO CHEMICALS PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00915/AM17/ RLA File :05/23/040/00293/AM17/ Lic.No/Date:0510400012 04.10.2016 Defer Date:22.03.2017 408

Case No.:114/16/82-

ALC4/2016 PVT.LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00931/AM17/ RLA File :05/23/040/00315/AM17/ Lic.No/Date:0510400010 04.10.2016 Defer Date:22.03.2017

66 409

Case No.:117/16/82-

ALC4/2016 PVT.LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00934/AM17/ RLA File :05/23/040/00316/AM17/ Lic.No/Date:0510400011 04.10.2016 Defer Date:22.03.2017 410

Case No.:17/16/82-

ALC4/2016 Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00834/AM17/ RLA File :05/23/040/00322/AM17/ Lic.No/Date:0510400064 06.10.2016 Defer Date:22.03.2017 411

Case No.:3/16/82-ALC4/2016 Party Name:DIVIS

LABORATORIES LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00820/AM17/ RLA File :09/24/040/00346/AM17/ Lic.No/Date:0910064248 06.10.2016 Defer Date:22.03.2017 412

Case No.:5/16/82-ALC4/2016 Party Name:DIVIS

LABORATORIES LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00822/AM17/ RLA File :09/24/040/00363/AM17/ Lic.No/Date:0910064249 06.10.2016 Defer Date:22.03.2017 413

Case No.:62/16/82-

ALC4/2016 SOLVENTS LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00879/AM17/ RLA File :05/24/040/00285/AM17/ Lic.No/Date:0510400053 06.10.2016 Defer Date:22.03.2017 Decision :Deferred. 414

Case No.:88/16/82-

ALC4/2016 SOLVENTS LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00905/AM17/ RLA File :05/24/040/00206/AM17/ Lic.No/Date:0510400054 06.10.2016 Defer Date:22.03.2017 Decision :Deferred. 415

Case No.:116/16/82-

ALC4/2016 SOLVENTS LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00933/AM17/ RLA File :05/24/040/00237/AM17/ Lic.No/Date:0510400057 06.10.2016 Defer Date:22.03.2017

67 Decision :Deferred. 416

Case No.:143/16/82-

ALC4/2016 Party Name:ARJUN CHEMICALS PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00960/AM17/ RLA File :04/24/040/00118/AM17/ Lic.No/Date:0410162358 07.10.2016 Defer Date:22.03.2017 417

Case No.:68/16/82-ALC4/2016 Party Name:JUBILANT

GENERICS LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00885/AM17/ RLA File :05/23/040/00299/AM17/ Lic.No/Date:0510400077 07.10.2016 Defer Date: Decision : The Committee decided to ratify norms based on the earlier recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/69/2013-PI(Norms) dated 1.4.2013, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per decision of NC. 418

Case No.:73/16/82-ALC4/2016 Party Name:JUBILANT

GENERICS LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00890/AM17/ RLA File :05/23/040/00298/AM17/ Lic.No/Date:0510400076 07.10.2016 Defer Date: Decision : The Committee decided to ratify norms based on SION A-412 or as applied by the firm whichever is less. RA concerned may take further necessary action as per decision of NC. 419

Case No.:118/16/82-

ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00935/AM17/ RLA File :05/24/040/00334/AM17/ Lic.No/Date:0510400083 07.10.2016 Defer Date:22.03.2017 420

Case No.:75/16/82-

ALC4/2016 SOLVENTS LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00892/AM17/ RLA File :05/24/040/00125/AM17/ Lic.No/Date:0510400069 07.10.2016 Defer Date:22.03.2017 421

Case No.:79/16/82-

ALC4/2016 SOLVENTS LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00896/AM17/ RLA File :05/24/040/00277/AM17/ Lic.No/Date:0510400073 07.10.2016 Defer Date:22.03.2017

68 422

Case No.:101/16/82-

ALC4/2016 SOLVENTS LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00918/AM17/ RLA File :05/24/040/00115/AM17/ Lic.No/Date:0510400070 07.10.2016 Defer Date:22.03.2017 423

Case No.:55/16/82-ALC4/2016 Party Name:DSM SINOCHEM

PHARMACEUTICALS INDIA PVT.LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00872/AM17/ RLA File :22/24/040/00060/AM17/ Lic.No/Date:2210015578 10.10.2016 Defer Date: Decision : The Committee decided to ratify norms based on SION A-3667 published vide PN No.64 dated 17.03.2016 or as applied by the firm whichever is less. RA concerned may take further necessary action as per decision of NC. 424

Case No.:74/16/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00891/AM17/ RLA File :05/23/040/00323/AM17/ Lic.No/Date:0510400088 13.10.2016 Defer Date:22.03.2017 425

Case No.:129/16/82-

ALC4/2016 Party Name:AMANTA HEALTHCARE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00946/AM17/ RLA File :08/24/040/00273/AM17/ Lic.No/Date:0810138843 14.10.2016 Defer Date:22.03.2017 426

Case No.:121/16/82-

ALC4/2016 Party Name:BIO TECH OPHTHALMICS PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00938/AM17/ RLA File :08/24/040/00281/AM17/ Lic.No/Date:0810138874 18.10.2016 Defer Date:22.03.2017 427

Case No.:126/16/82-

ALC4/2016 Party Name:BIO TECH OPHTHALMICS PVT LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00943/AM17/ RLA File :08/24/040/00278/AM17/ Lic.No/Date:0810138860 18.10.2016 Defer Date:22.03.2017 428 Case No.:127/16/82- Party Name:BIO TECH Meet No/Date:18/82- Status:

69 ALC4/2016 OPHTHALMICS PVT LTD ALC4/2016 15.02.2017 Deferred HQ File :01/82/050/00944/AM17/ RLA File :08/24/040/00280/AM17/ Lic.No/Date:0810138861 18.10.2016 Defer Date:22.03.2017 429

Case No.:107/16/82-

ALC4/2016 Party Name:DALAS BIOTECH LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00924/AM17/ RLA File :05/23/040/00474/AM16/ Lic.No/Date:0510400138 18.10.2016 Defer Date:22.03.2017 430

Case No.:20/16/82-

ALC4/2016 KABI ONCOLOGY LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00837/AM17/ RLA File :05/23/040/00339/AM17/ Lic.No/Date:0510400130 18.10.2016 Defer Date:22.03.2017 431

Case No.:54/16/82-

ALC4/2016 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00871/AM17/ RLA File :22/24/040/00065/AM17/ Lic.No/Date:2210015580 18.10.2016 Defer Date:22.03.2017 432

Case No.:108/16/82-

ALC4/2016 SCIENCES LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00925/AM17/ RLA File :05/23/040/00303/AM17/ Lic.No/Date:0510400129 18.10.2016 Defer Date:22.03.2017 433

Case No.:89/16/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00906/AM17/ RLA File :05/24/040/00321/AM17/ Lic.No/Date:0510400153 19.10.2016 Defer Date:22.03.2017 434

Case No.:26/16/82-

ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00843/AM17/ RLA File :31/83/040/00055/AM17/ Lic.No/Date:3110066375 20.10.2016 Defer Date:22.03.2017 Decision :Deferred.

70 435

Case No.:113/16/82-

ALC4/2016 Party Name:KLJ Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00930/AM17/ RLA File :05/23/040/00346/AM17/ Lic.No/Date:0510400173 20.10.2016 Defer Date:22.03.2017 Decision :Deferred. 436

Case No.:80/16/82-

ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00897/AM17/ RLA File :05/24/040/00344/AM17/ Lic.No/Date:0510400193 20.10.2016 Defer Date:22.03.2017 437

Case No.:53/16/82-

ALC4/2016 Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00870/AM17/ RLA File :22/24/040/00066/AM17/ Lic.No/Date:2210015582 21.10.2016 Defer Date:22.03.2017 438

Case No.:87/16/82-

ALC4/2016 Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00904/AM17/ RLA File :05/23/040/00287/AM17/ Lic.No/Date:0510400238 24.10.2016 Defer Date:22.03.2017 Decision :Deferred. 439

Case No.:13/14/82-

ALC4/2016 Party Name:ARIHANTANAM LIFECARE PVT. LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00811/AM17/ RLA File :52/24/040/00047/AM17/ Lic.No/Date:5210042055 25.10.2016 Defer Date:22.03.2017 440

Case No.:86/16/82-

ALC4/2016 Party Name:HELLO PAINTS (P) LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00903/AM17/ RLA File :05/23/040/00351/AM17/ Lic.No/Date:0510400251 25.10.2016 Defer Date:22.03.2017 Decision :Deferred. 441

Case No.:51/16/82-

ALC4/2016 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File RLA File Lic.No/Date:2210015583 Defer

71 :01/82/050/00868/AM17/ :22/24/040/00067/AM17/ 25.10.2016 Date:22.03.2017 442

Case No.:67/16/82-

ALC4/2016 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00884/AM17/ RLA File :05/24/040/00355/AM17/ Lic.No/Date:0510400261 25.10.2016 Defer Date:22.03.2017 Decision :Deferred. 443

Case No.:102/16/82-

ALC4/2016 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00919/AM17/ RLA File :05/24/040/00318/AM17/ Lic.No/Date:0510400258 25.10.2016 Defer Date:22.03.2017 Decision :Deferred. 444

Case No.:122/16/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00939/AM17/ RLA File :08/24/040/00289/AM17/ Lic.No/Date:0810138976 26.10.2016 Defer Date:22.03.2017 445

Case No.:123/16/82-

ALC4/2016 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00940/AM17/ RLA File :08/24/040/00307/AM17/ Lic.No/Date:0810138972 26.10.2016 Defer Date:22.03.2017 446

Case No.:115/16/82-

ALC4/2016 Party Name:KLJ Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00932/AM17/ RLA File :05/23/040/00329/AM17/ Lic.No/Date:0510400281 26.10.2016 Defer Date:22.03.2017 447

Case No.:19/16/82-

ALC4/2016 Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00836/AM17/ RLA File :05/23/040/00355/AM17/ Lic.No/Date:0510400295 27.10.2016 Defer Date:22.03.2017 448 Case No.:130/16/82- ALC4/2016 Party Name:IOL CHEMICALS AND Meet No/Date:18/82- ALC4/2016 Status: Deferred

72 PHARMACEUTICALS LIMITED 15.02.2017 HQ File :01/82/050/00947/AM17/ RLA File :30/24/040/00027/AM17/ Lic.No/Date:3010103875 27.10.2016 Defer Date:22.03.2017 449

Case No.:52/16/82-

ALC4/2016 Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00869/AM17/ RLA File :22/24/040/00038/AM17/ Lic.No/Date:2210015587 27.10.2016 Defer Date:22.03.2017 450

Case No.:14/14/82-

ALC4/2016 Party Name:CONCORD BIOTECH LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00812/AM17/ RLA File :08/24/040/00264/AM17/ Lic.No/Date:0810138999 28.10.2016 Defer Date:22.03.2017 Decision :Deferred for want of comments from DBT. 451

Case No.:66/16/82-

ALC4/2016 SOLVENTS LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00883/AM17/ RLA File :05/24/040/00339/AM17/ Lic.No/Date:0510400305 28.10.2016 Defer Date:22.03.2017 452

Case No.:71/16/82-

ALC4/2016 SOLVENTS LTD., Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00888/AM17/ RLA File :05/24/040/00360/AM17/ Lic.No/Date:0510400306 28.10.2016 Defer Date:22.03.2017 453

Case No.:11/16/82-

ALC4/2016 Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00828/AM17/ RLA File :31/83/040/00094/AM17/ Lic.No/Date:3110066388 31.10.2016 Defer Date:22.03.2017 454

Case No.:18/16/82-

ALC4/2016 Party Name:HONOUR LAB LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00835/AM17/ RLA File :09/24/040/00417/AM17/ Lic.No/Date:0910064330 31.10.2016 Defer Date:22.03.2017

73 455

Case No.:15/14/82-

ALC4/2016 Party Name:MICRO LABS LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00813/AM17/ RLA File :07/24/040/00255/AM17/ Lic.No/Date:0710110609 02.11.2016 Defer Date:22.03.2017 456

Case No.:16/14/82-

ALC4/2016 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00814/AM17/ RLA File :04/24/040/00133/AM17/ Lic.No/Date:0410162482 10.11.2016 Defer Date:22.03.2017 457

Case No.:65/16/82-

ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00882/AM17/ RLA File :31/83/040/00106/AM17/ Lic.No/Date:3110066397 15.11.2016 Defer Date:22.03.2017 Decision :Deferred. 458

Case No.:134/16/82-

ALC4/2016 Party Name:ARIHANTANAM LIFECARE PVT. LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00951/AM17/ RLA File :52/24/040/00054/AM17/ Lic.No/Date:5210042082 05.12.2016 Defer Date:22.03.2017 459

Case No.:135/16/82-

ALC4/2016 Party Name:ARIHANTANAM LIFECARE PVT. LTD. Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Deferred HQ File :01/82/050/00952/AM17/ RLA File :52/24/040/00055/AM17/ Lic.No/Date:5210042083 05.12.2016 Defer Date:22.03.2017 460

Case No.:144/16/82-

ALC4/2016 Party Name:SRIAM LABS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File :01/82/050/00961/AM17/ RLA File :09/24/040/00502/AM17/ Lic.No/Date:0910064500 21.12.2016 Defer Date: Decision :Already approved in NC 16/82 461

Case No.:2/18/82-ALC4/2016

PHARMA LIMITED Meet No/Date:18/82- ALC4/2016 15.02.2017 Status: Approved HQ File RLA File Lic.No/Date:0910064625 Defer Date:

74 :01/82/050/01177/AM17/ :09/24/040/00587/AM17/ 01.02.2017 Decision : The Committee decided to ratify norms based on SION A-3648 published vide PN No.64 dated 17.03.2016 or as applied by the firm whichever is less. RA concerned may take further necessary action as per decision of NC. Manual Agenda of NC Meeting No.18/82/2016 Scheduled to be held on 15.02.2017 but actually held on 22.02.2017

Case No. B- 01

M.No.18/AM-17 Date 15.02.2017 M/s. Polydrug laboratories Pvt.Ltd. File No.01/82/50/900/AM16 RLA File No.03/95/40/00219/AM16 Adv.Auth.No.0310797101 dt.07.07.2015 Decision: The Committee considered this case for amendment in the description of import item “Methyl Isopropyl amine” to “Mono Isopropyl Amine” as per agenda. The representative of D/o Pharmaceuticals stated in the meeting that both the items are different. Therefore, for calculation of quantity of import item Mono Isopropyl Amine, information as per Appendix 33 is required. The Committee accordingly, decided to call for information as per appendix 33 from the firm and deferred the case.

Case No. B- 02

M.No.18/AM-17 Date 15.02.2017 M/s. The Andhra Sugars Ltd. File No.01/82/171/37AM17 Decision: The Committee considered the request of M/s. The Andhra Sugars Ltd. for modification/amendment in the description of export item to read as “Acetyl Salicylic Acid (Aspirin)” instead of “Acetyl Salicylic Acid” mentioned in SION A-39 as per agenda. The Committee deferred the case and to be relisted in next meeting.

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隊 一 イ 1諸∬究Tα 34003劉00 Decision : Committee considered the case as per agenda and in the light of written forwarded by Department of Chemicals and Petrochemicals vide their U.O No. 14010/8/2010-Ch.II dated 30.8.2010 and in consultation with the technical authorities in the meeting and also based on details of manufacturing process furnished by the firm, decided to ratify norrns under Para 4.7 of HBP v I as per details below or as applied by firm whichever is lower: RA may take appropriate action as per the decision ofNorms Committee. Party Name:TATVA CHINTAN Meet No/Date:41/82- PHARMA CHEM PVT LTD ALC4/2011 10.01.2012

Case No.:24/41/82‐ ALC4/2011

Triphenyl Phosphine Ethyl Bromide Acetonitrile 0.850 kg O.360 kg ｀ヽ、シ 1器疏50/O1025晨mν

ICase No.:195/3/82-ALC4/2014 Party Name:JAINEX SPECIALITY CHEMICAL 19 巧′ 9 Mcet No/Date:3/82- ALC4/2014 08.05.2014 Lic.No/Date:3410039038 17.01.2014 )ecision : ln the light of written comments received from Department of Chemicals and ,etrochemicals vide their U.O No. 14010/1612OL4-C. ll dated L3.06.2Ot4, it was decided to atify norms under Para 4.7 of HBP vi. as per details given below or as applied by the firm, vhichever is less: Export product ｙ 呻 Ｑ ｕ ａ ｎ ｔ ｉ S.No. lmport items Quantity Allowed CALCIUM BUTYRATE l kg 1 BUTYRIC ACID 0.788 kg RA may take appropriate action as per the decision of Norms Committee.

者 RA concerned may take fu CHEMICALINDUSTRIES LIMITED 1′82′ 050′ 00993′AM12/DES‖ | Norms Committee Meetinq No.2slAM'l 3 No 03′95/040700718/AM12 Meeting Date1 29 11 2012 10670262 dated 13 12 2011 Advance licence No. & date already been approved in Decision: It was noticed that this case datcd 29 11 2012 Hencc the casc、val AM 097DES III(Pt) No 27/AM13 Meeting Date: 31 .1 Adv Lic No 0310481979 dated 8 8 2008 @therequestofthelirmtoDepartmentofPharmaceuticalsagain for their comments. Accordingly, the case was deferred for 24.01.2013. M/s PREGNA INTERNAT10NAL LTD

Case No B 427

F No 01′ 82′ 050/00941/AM 13/DES‖ 1 Norms Commltee Meeing No 27′AM13 RAF‖e No 03/95/040/006353/AM 12 Meetng Date:31 122012 Adv Lic No 0310665072 dated 15 11 11 Decision: Committee considered case as per agenda and in light of written comments fonvarded by Deptt of C&pC vide their U.O.No. 46O77122/2O08-PCil dated 03.12.2012 and in consultation with technical authority present in meetinS, decided to ratify norms under para 4 7 of HBP as per details below or as applied by firm whichever is lower:-

Case No B 425

Case No B 426 ノ//

tvtls. Arctr pnarmalaby'Limited, Mumbai RA日峰No 03′94//40/00393/AM 09 ′

3. ltem to be exported Quantity rNTRA UTERINE CONTRACEPTIVE DEVICE‐ CU 375 l No Raw material recommended to be imported Quantity / kg 1 COPPER VVIRE{9999%PURITY) 0 000416 kg 2 HDPE GRANULES 0 001385 kg POuCHES(PLASTIC) Net+10% 4 COMPOUND OF LDPE RESiN&BARIUM SULPHATE 0 0000775 kg PVC GRANULES 0 000695 kg HDPE GRANULES(OR NYLON RESlN)MEDICAL GRADE 0 000035 kg COPPER WIRE WiTH SiLVER CORE COMPOuND OF LDPE RES N& POUND OF LDPE RESIN&BARIUM HDPE GRANULES(OR NYLON POLYPROPYLENE GRANULES

RA concerned may take further necessary action as per above decision of NC 5. Item to be exported Quantity INTRA UTERINE CONTRACEPTIVE DEVICE― COPPER T 380 A WITH SAFE LOAD l No. Raw material recommended to be imported Quany(t I ke COPPER VVIRE{99.99%PUR:TY) 卿 0204 kg 2. HDPE GRANULES / 0.001203 kg 3. FUCHEttP臥 釧0 / Net+10% 4. COPPER TUBE(99.99%PURITγ )
ノ/// 0.000169 kg POLYPROPYLENE GRANULES ///// 0.001742 kg 6 COMPOUND OF LDPE RES:N/BARIUM SULPHAttE 0.000415 kg 7. PVC GRANULES / 0.00661 kg 8. HDPE GRANUL/{OR NYLON RES!N)MEDICAL GRADE 0.000178 kg 9. POLYPROPYLENE GRANULES 0.002918 kg 4. ltem to be exported INTRA UTERINE CONTRACEPTIVE DEVICE‐ COPPER T 380 A Raw material recommended to be imported COPPER VV:RE(99.99%PUR:lY) COPPER TUBE{99.99%PU RES:N&BAR:UM SULPHATE 0.000415 kg HDPE GR,利ULES(OR NYLON RES!N)MED:CAL GRADE 0.000177 kg

F No 35011/437ノ2015-P:(Norms) Government Ofindia Ministry Of chemical&Ferti‖ zers
｀ Department of Pharmaceutlcals Udyog Bhawan, New Delhi, Dated: August,2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of procedures (Vol.r) 200g-14 case

of M/s Alchem lnternational (p) Ltd. . . . ]he y$ersigned is directed to refer to DGFT U.o.No. olt}2tsots3gtAM_16/DEs_3/610 dated the 1517115 vide which application from M/s Atcrrem lnternationai 1FJ LiJ. was sent to this Department for fixation of norms under para: 4.7 for the export of Digoxin. This department has examined the matter and the following norms are.furnisneo unuer'paia'4.i'o-f Hand Book of Procedures (Vol.l) 2009-14:- This issues with the approval of competent authority. (Ralkumar) Under secretary tO the Covernment oflndia PH:-23071162 3諄:憮:ぶⅧ謂:雷° n.adQ 滉品y計鼎::1騨&編 ヱ 嘔 Digitalis Lanata Leaves 266.64kg/kg Digoxin

F. No.350 l 1 126812015-PI Qrtorms) Government of India Ministry of Chemicals & Fertilizers Department of Pharmaceuticals 工 摯 Udyog Bhawan,New Delhi, Dated the October,20l5 Subject:.Fixationo{19rmsunderou,uffiProcedures(Vol.l)200g-l4CaseofM/s Nutra Specialities pvt Ltd. The undersigned is directed to refer to DGFT U.o.No. 0ug2r50r75rAM-r6rDEs-3/r7 dated the 11106115 vide which application from M/s. Nutra specialities Pvt Ltd was sent to this Department for fixation of norms under para: 4.7 for the. export of sitagliptin_plrosphate (ApIs/ Bulk Drugs). This department has examined the matter and it is requesteJ-r-fiut ocpr may call following technical details from the firm viz:- (a) Norms applied by the firm does not match with the yields given by the firm i.e. g0%xg0,5% x90% in 3 step reactions. Detailed calculationsljustifica"ti;;fi; furnished by the firm. (b) Past production vis-d-vis Actual .on.u-piion oi imported in;;r-;rry cerrified by centar Excise Authorities may be furnished in support of their claim. Directorate General of Foreign Trade, Department of Commerce, (Shri M.V. Singh, FTDO), Udyog Bhawan, New Delhi (Barnali Khastgir) Under Secretary to the Government of India Phone:23071162

F. No.350I I1240/2015-PI (Norms) Government of India Ministry of Chemicals & Fertilizers Department of Pharmaceuticals “ 一 “ Udyog Bhawan,New Delhi, Dated the September, 2015 Office Memorandum

Subject: - Fixation of norms under para 4.7 of ff*a gook of Procedures (Vol.l) 2009-14 Case of M/s

Mylan Labs Ltd. The undersigned is directed to refer to DGFT U.o.No. ot/g2l5oll04lAw-16/DEs-3/105 dated the 16106115 vide which application from M/s. Mylan Labs Ltd was sent to this Department for fixation of norms under para:4.7 for the export of N{a-iuorobenzyl) 5-hydroxy-l-methyl-2-(2-{t(s-methyl- 1.3. 4-oxadiazol-2-yl)carbonyllamino) propan-2-yl)-6-o*o-t o-ait ydro pyrimidine-4-carboxamide. This department has examined the mattei und it is requested that DGFT may call ..past production vis-ir- vis Actual consumption of all imported inputs duly certified by Central Excise Authorities,,. (Shd M.V. Singh, FTDO), Udyog Bhawan, New Delhi (Barnali Khastgir) Under Secretary to the Government of India Phone:23071162

F.No.憾 :|:ζ凛鮒:finf°mS) .■ アタ Mhistry ofChemたds&Fertihzers ‐ 57 Department ofPhallllaceuticals 、 Udyog Bhawan,New Delhi, Datedthe September,20l5 Office Memorandum

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

Suven Life Sciences Ltd. The undersigned is directed to refer to DGFT U.o.No. 0llg2l5oll25luw-t6lDEs-3(24x11) dated the ll106115 vide which application from M/s. Suven Life Sciences Ltd was sent to this Department for fixation of norms under pata: 4.7 for the export of 5-chlorothiophene-2-carboxylic Acid (s-cTA). This department has examined the matter and ihe following norrns are furnished under para4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S.No. Import Item Qty. Recommended kg/kg. 1 Ihiophene 1.04 (Barnali Khastgir) Under Secretary to the Government of India Phone:23071162 DircctOrate Genera1 0f Foreign Tradc, Department of cOmmcrce, (Shri M.Vo Singh,FTDO), Udyog Bhawan,New Delhi

Case No。:12/10/82- ヽLC4ノ2014 IPtty Namc:SHIVA IPHARMACHEM LTD, 1濶 滋 Status: Approved )File /82/050/00926/AM15/ Filc ∞ /AM剛 1鼎鼎 | 1 Decおion:ln the‖ght of w百tten commentsたceived from Department Of chemi冨薦and petrochemicals vide their U.o No.14010/164/2011‐ Ch.‖ dated 12.12.2014′ it was decided to ・atify norms under Para 4.7 of HBP vl as per detai:sg市 en be!ow Or as app!ied by the irm′ ″hichever is less: Export product Export Qtv. S.No Import items Quantity A‖owed 3,5‐ Dimethylbenzoyl ChloHdc(DMBC) Assay:Min 99% l kg 1 Mesiyylene / 1,3,5-Trimethyl benzene Assay: Min 99% 1.128 kg may take riate action as per the decision of Norms Committee. 慮 τ

券 Decision : Committee considered the case as per agenda and in consultation with the authority present in the meeting, it was decided to amend the description of export the minutes ofthe NC meeting no.46/82 dated 15 02 201l as detalls given below The rest the minutes would remain same. From lo Export Product as allowed by NC Export Product as applied by the firm n‐ Valcryl ch10ridc Valeryl Chloride / n-Valeryl Chloride Import items as allowed by NC Import items as applied by the firm n-Valeric Acid Valeric Acid/n‐Valcric Acid RA may take appropriate action as per the decision of Norms Committee. Casc No B‐ 93 M/S Shiva Pharma.Ltd′ Mceting No 10/AM15 dated-13112014 File No.01/82/050/01586/AMl1/DES― |‖ RAF No.34/24/040/00271/AMll Adv.Lice.No 3410029154 dated 24.01.2011

? /o 叩 Ｃ Ｈ Ｅ Ｍ ０ ０ Ｎ 氾 Ｓ ｅ Ｃ ４ ａ Ｌ Ｃ Ａ 86

Case No.:45114182- jearty Name:GULBRANDSEN iuiet No/Date:18/82- istatusc;;

ALC4|2O11 icHEMtCALS pVT LTD 1ALQ412O11 iApproved i i02.08.2011 I HO Frre - l-RtA F't" -lLicNo/Date341OO3O424 l- :01t82t050t00436tAu12t i:34t24tO4OtOOO35/AM12/ iar.os.zor r I pe.ag 1/11 meeting held on 06.04.2010 and in consultation with technicalauthority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied tiy the firm whichever is lower:- Export product Exp.Qtv. SI.No. lmport items Qty. allowed Monobutyl Tin Trichloride l kg 1. Tin lngots 0.497 kq 2 Aluminium Grits/Granules 0 062ko 3. Butene-1 0.450 kq Di-n-ButylTin Oxide l kg Tin lngots 0.564 kg 2 Aluminium GritVGranules 0.096 kq 3. Butene-1 0.730 kq concerned may take further necessary action as per above decision of NC.

TL-12024 130 /201 6-GC and F-DCMSME Govemment of lndia Ministry of Micro, Small and Medium Enterprises Office of Development Commissioner (MSME) (Chemical Division) 7th Floor, Nirman Bhawan, New Delhi-110108 16th February, 2017 OFFICE MEMoRANDOM *i.t

Subject: Ratification ofthe norms in respect of advance authorization No.

0310792363 dated 24.01'2014, under Para 4.7 of HBP obtained by M/s National Tube Industries, Mumbai. Please refer to above referred application of advance authorization No. 0310792363 daled 24.01.2014 requesting ratification of the norms for the Export of Silicone oil 1.0 and 2.0 cst. The application has been examined and following information/details may please be arranged from M/s National Tube lndustries, Mumbai so as to decide the norms of advance license:-

1. Technical specifications differentiating between Silicone oil as import input and Silicone oil as export product, as same ITCHS code has been stated for both in the application.
2. The details of ratified norms by NC Committee in respect of erstvvhile advance authorization dated 3.12.2014, as stated in the application.
3. List of machinery/equipments employed in the manufacture of Export product (Silicone oil), especially for the processes/steps stated in the process flow charUsheet along with a brief outlined process.
4. The uses and applications of export product.
5. Details of the recovery or re-activation of Sulfonated Siloxane, used as catalyst in the polymerization to manufacture Silicone oil.
6. Status of the Exporter, i.e whether M/s National Tube lndustries is an importer & Supplier of Chemicals or Manufacturer Exporter. lf it is manufacturer Exporter, the address of manufacturing unit may be provided.
7. Rectification of discrepancies in the undertakings submitted in the application in respect of Declaration /undertakings in terms of Pata 4.714- 4-2 of hand book of procedures. This issues with the approval of competent Authority. Singh) To. l/'" Shri Nirmal Kuma(Dy. Director) R.No.3 e3, O/o Director General of Foreign Trade, DES-Ill Section, Udyog Bhawan, New Delhi lr 12- Asstt. Director (Chemical)

⌒

上 ” ⌒ iCase No.:166/3/82‐ Party NameiVIJAY IMcct No/Date:16/82‐ Status: : :ALC4/2014 PERFUMES PVT LTD IALC4/2014 1Approved i l l 123 01 2015 1 : "oint ittLA liお

ぷどヽも,Datbji6カb685■lb:お| | 101/82/050/00170/AM15/ 1:03/95/040/00916/AM14/ l18022014 1 1 1tまきおI:ili:1」薦:i喜五LI:ふ孟:魚誕:ま↓::諄:ふЬ::11:鳥:Fふ詰 :::品:iξ ↓ぬ:hよib紡 :No 350H355/2014-PI(Norms)datcd 28 01 2015,I was dccidcd to rajfi/the norms under Para 4 7 of iHBP Vl as pcr dctails g市cn below or as applicd by thc frm,whichevcr is icssi l Export Product Ｖ ｎ ｔ ｌ 師 Ｏ ｕ ａ ｎ S No Import Itern Qty.Allowcd kg/kg N-Methyl Benzothiazene Methl'l Ester l kg 1 Sodium Saccarinc BP/USP/1P Dimethyl Formamide 050 Sodiumヽ4ctal 0337 4 Methyl Alcohol Acetone Xylene 0645 7 Methyl Chloro Acetate :RA may take appropriate action as per the decision of Norms Committee.

F No 35011ノ207ノ2016-PI(Norms) Government ofindia Ministry Of Chemical&Fertilizers Department of Pharmaceulcals ノ お Dated: September,2016 Office Memorandum

subject: - Fixation of norms under para 4.7 of Hand Book of procedures (Vor.r) 2009_.14 case

of M/s BTL Exports (p) Ltd. The undersigned is directed to refer to DGFT u.o.No. 01tg2tsor1o4,1o05, 1g42lAM_ 17IDES-3/3j5, 316, 317 dated the 2gnn6 uio- rhi"h -rppri"ation tiom nil. eir Exports (p) Ltd' was sent to this Department for tixation or norms under'para: a.z ror 6e exp'ort of Ascorbic acid coated Bp. This department nas examineJ the matter and the rottowing norms are furnished under para 4.7 of Hand Aoot of Fr;c;juiu. lvot.ty 2009_14:_ DGFT is advised to call following details from the firm viz:_ '1. Copy of varid drug manufacturing ricense for the export product with approved composition. 2 Fum has shown-S% wastage in one apprication and 220/0 wastage in another apprication. Justification for iuch variation ,n.y 6" trini.r,-J. "-'''= 3 Firm has shown use of 50 liters of steiryl alcohol *iir, io6or,s ascorbic acid in ftow diagram. However, in the CA certlficate, it is;ho;;a"s? Oy weight. Technicar justification for such variation may be furnished. Actuar content of . stearyl alcohol in export product may be furnished. 4 coA/Test report of the export p.tr"t vis-a-vis specification given in British pharmacopoeia may be furnished. 5 Past production vis-d-vis actuar consumption of import item dury certified by Central Excise Authorities may be furniihed. 2. UndersecretarytotheGovernmf:lン‖品! PH:-23071162 ヽ |

“ ７ ILic No/Datei3410033125 106.02.2012 Defer Date: 227 | 1/82/050/01322/AM12/ ::34/24/040/00228/AⅣ112/ 106.02.2012 Decision : Comrnittee considered case as per agenda and in the light of written comments received lrom Department of Chemicals and Petrochemicals vide their U.O No. 140101'161201O-Ch.ll dated 27.9.2010 and in consultation with technical authority present in meeting, decided to ratify norms under Para 4.7 of Handbook of Procedures as per details below or as applied for by firm whichever is lower:- Export Product Export Qty. S.No. Name of Item of import Quantity allowed 1,3 Dichloro Acetone l kg 1 1,3 Dichloro-2-Propanol 1 069 kg う ４ Sodium Dichromate 1.70 kg may take appropriate action as per the decision of Norms Committee. iCase No.:13/49ノ82- Party Name:RIDDHI Meet No/Dtte:49/82- Status:Case lALC4ノ2011 ,PHARMA IALC4/2011 iApproved .0603.2012 1

F. No.3 50 I I I 63412012-PI (Norms) Government of India Ministry of Chemi cal & Fertilizers Department of Pharmaceuticals Udyog Bhawan, New Delhi, the 12th March, 2013 Office Memorandum

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

Case of IWs. Promed Exports Pvt Ltd. The undersigned is directed to refer to DGFT U.O.No. Oll82l501614lAML3/DES- 31778 dated the 03107112 vide which an application from IWs. Promed Exports Pyt Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Cyclomed Eye Drops t% 5ml (Net content of bulk drug=92.593 kgs). This department has examined the matter and the following comments are furnished under para4.i of Hand Book of Procedures (Vol .l) 2009-14:- S. No. Import Item Qty. Recommended. 1 Cyclopentolate HCL 51.0 mg per 5 ml vial This issues with the approval of Director (Cortl (N.N.Ahuja) Section Officer PI-Norms (Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi. 2.

F. No.3501 1 /82212015-Pl (Norms) Government of lndia Ministry of Chemical & Fertilizers Department of Pharmaceuticals ヘ バ 、 ヽ タ Dated: 23 May, 2016 Office Memorandum

subject: - Fixation of norms under para 4.7 of Hand Book of procedures (vol.l) 200g-14 case

of M/s Mylan Labs Ltd. ^. --The undersigned is directed to refer to DGFT U.o.No. o1tB2tsol134otAM-16/DES- 311420 daledlhe 1111116 vide which application from lvtls trrtytan Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of iumeiantrine. rnis department has examined 1!e. r-n1le-r and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- The firm was advised to furnish following details:-

1. complete technical detair as per appendix-33 showing % yield on molar basis, recovery of solvent etc.
2. Copy of technical literature in support of the yield envisaged above.
3. Past production vis-d.-vis actual consumption of all imporied inputs duly certified by central excise authorities. DGFT may again be advised to call above details from the firm.

Under secretary to the o"r"r.r$i'ji,Ti'l PH- 23071162 (Shri M.V. Singh, FTDO), Udyog Bhawan, New Delhi

OfFce MemOrandum SuЦedf寵 礼lllⅧ習:出濯こ =47び Hand BOOk d PЮcedures(b助200944 Case 詔 絲 i警『 f#i研 轡 帯f慧職 織 曇 1薦 薔f脳 #:熟織 T兼 department has examined the matter and the l Hand BoOk of Procedu「es(VOII)2009_14■ DGFT is adv sed to ca‖ fO‖ Owing deta‖ s frOm the lrm viz: ・鵬:釉■設器1肥篇::3ⅢF″品1獣f懲魁 :Ю dua spednc aЮ ngh 2 Deta‖ ed wOrking On the norms applied may alsO be given F. No.3501 1/761/2015-pt (Norms) Government of lndia Department of Pharmaceuticals tq4-rq\l
Udyog Bhawan, New Dethi, Dated: 5, May 20j6 (Ralkumar) Under secretalγ tO the Government Oflndia PHi‐ 23071162 2. This issues with the approval ofcompetent authority. 3撃:躍it讐辮謂 :雷° n.調Q (ShH M V Sngh,FTDO), Udyog Bhawan,New De hi

F. No.350 1 I I 109120t5-pl gtrorms) Government of India Ministry of Chemicals & Fertilizers Department of Pharmaceutical s 形 Udyog Bhawan,New Delhi, Dated the October, 2015 Subject:-Fixationofnormsunderou.uomProcedures(Vol.l)200g-l4CaseofM/s Venus Renedies Ltd. The undersigned is directed to refer to DGFT U.o.No. 07l2r5ofi354rANr-r5rDES-3/1290 dated the 04103115 vide which application from M/s. Venus Renedies Ltd was ,.rr;";;;.r*?[fi a, fixation of norms under pati: 4.7 for the export of Fluorouracil Solution for Injection 250mg/5ml & 500mg/10mt' This department has examin.a tn. matter and the following norrns are fumished under para4.7 of Hand Book of procedures (Vol.l) 2009_14:_ E)irectOrate Genera1 0fForeign Trade, Department of cOmmerce, (Shri M.V.Singh,FTDO), UdyOg Bhawan,Ncw Delhi Undcr secretary tO the G:ll器:IIIFIII: Phonc:23071162 Import Item Qty. Recommended. -Fluorouracil Bp 275mg/5nll vial And 550mg/1 olni vial

F. No. 3 5 0 I I I 4 I 0 t20 I 4-pI (Norms) Government of India Ministry of Chemi cal & Fertilizers Department of pharmaceuticals ザ Udyog Bhawan, New Delhi, the January, 2Ot5 Sub:Fixationofnormsunderou*ffiProcedures(Vol.l)200g-14Case of M/s. Shasun pharmaceuticals Ltd. The undersigned is directed to refer to DGFT u.o.No. 0ugzr5or275 &2521AM15/DES-3 l42l & 419 dated the 25/07114 vid,ewhich an application from lz7s. Shasun Pharmaceuticals Ltd was t:n1 1o this Department for fixation of norms under para: 4'7 for the export of Paroxetine Tablets. rhis'defaftment has examined the matter and the following comments are furnished under p^rui.l of Hand Book of procedures (vol.l) 2009-14:- 2. This issues with the apprOva1 0fDirectOr(PI). under Secretary to the o""..nJ:;l51ffii? (!f i M.V. Singh, FTDO), Udyog Bhawan, New Oeitri ParOxetine Hyd ………―…―‐――-22.20mg/20mg tablets ―――――‐―……-33.30mg/30mg tablets & ----------44.40mg/40mg tablets

Fo No.350H/38/2012-PI(N0111ls) Govcmment Oflndia Ministry ofChelmicalく%Fertilizers Department ofPhallllaceuticals New Offlce Memoranduln Sub鷺榔席批:乳:Ta47」 Hand B00kぽPЮ∝ duКIvdめ This issues with the approval of Economic Advisor. The undersigned is directed to refer to DGFT U.o.No. 0r/g2r50/g42rAMr2rDES-3/133g dated the29ll0lll vide which an application from MA Jubilantiir. s.i.r.es rta *a. r.n to this Department for fixation of norms under paia: 4.7 for the export oroon"p"zitTabs 5 mg and 10 mg. This department lil.::ffi'l?$i5TfiBl,iy the rolowing .o,.n.nts are rumished undi;;;," 4.7 orHand-Book or :
｀ 1ル lqθ Udyog Bhawan, Delhi,the 13th July,2012. 2009_ 14 Casc OfM/s α .N.Ah可→ SectiOn Offlcer PI―NOrlns (Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi. Import Item Qty. Recommended DonepezilTablets 5 mg Donepezil HyA.ocfrto.iae 5.0 mg/5 mg tablets POnepezil Tablets lo mg P21ePCZil Hジdrochloride IH(US) 10.0 mg/l0 mg tablets

F No留 ;:f躍i::,記ir° rm→ Ministry Of chemical&Fertilizers Department of Pharmaceulcals 'orB:,31:*"l,HI ?flii Office Memorandum

subject: - Fixation of norms unde r para 4.7 0f Hand Book of procedures (Vor.r) 200g_14 case

of M/s Biological E. Ltd. The undersigned is directed to refer to DGFT u g \q o1t*2t5ot241tAM_17IDES_3/307 dated the 13rz 116 vide which apprication ri"r-N,r]."ai"r"g.icar E. Lid. was sent to this Department for fixation of norms rnd"r,!?r,";,4 7 tor tne export-J,f319"nin" Bp/Jp/USp (min. 98.5%). IT'"i;:il?t-iBil:$'ff"X'eiil,"ffii?1"tiu'tllroins norms are r,,,*n,lo under para DGFT is advised to call following details from the firm viz:_ lJ 9"n of the import item from foreion supotier ') :fl:::r:j,Hion vis-d-vis ".trli.-on.-ffiion of imported input durv certified by centrar 2. UndersecretarytOtheGovernmfttR品! PH:‐ 23071162

F. No.350 1 1 /1 0 1 12016_pt (Norms) Government of lndia uepartment of pharmaceuticals Ud瑶 :t出「Wa蹴 :y,現縄 OfFice MemOrandum Subjecti_FixatiOnofnOrmsulT[退 _ra 4 7 of Hand B00k of Procedures(vOl!)20o9_14 Case Of Mノs Strides shas 朧棚∫ξ :Fi錦[T辮端ξ 憫鱒馳織都 黒 :認:fツ:::」:酬f:誂黒 :箇∬蹄:溌踏tittCettiedbyhdrQChchttgebr 2 This issues with the apprOva1 0f cOmpetent authOrity Under secretary tO the Governm!i『酔lll! PH:-23071162

F. No.3501 1 t99t2016_pt (Norms) Government of lndia Ministry of Chemicals & Fertilizers み Sutted― Ap"闘mσ Mたぉd¨ EttmP 3:稽 『 蠍 期'糎 譜 L norms againstl可eCtable FormulatiOns 枷 5/2046 vide whiCh a肥肥牌胤馨1榊lw(1撻帽囃T norrns under para:4 7 fOrt gm,(:ii)Ceftazid:me fOr:可eC■on 50o mg,(iv)Gen 町eCtion 200 m3回Pd期 鰍 』tttt蹴 情:d10Q000u面 ぉ'И副&師)Pdymyガn B br tteCtion 2,50,Ooo units'v:a:.This E le rnatter and the nOrrns against the above prOduct are furnished as fO‖ Owsi_ ProOuct to OeEiporteE Raw mateJaにtO be:mpOrted Oescriptircn 咄幽皿L17蘇糠 :1昇1鼻円電 te¶iRe貴〔 男 :|∬ 出 r'11:tilq:S b」ffer-71ooo 咄出嘘懃ιや旱TT l邸 ::r,11:til。,S buffer 71ooo 蕊ヴ誦 Ste百le mixture Of C.eftaaidime pentahydrate yit]] Sodium Carbonate as 品あ C", vial. contains Gemcitabine HVOroJntriOe t to Gemcitabine 1000 cemc@ 卵 I: to Gemcitabine 200 cemc@ 麗草 :錮覆晃麗薫顧爾蔦恕薦蕊 ― O utttS eotymyxin-e Sutph_-ate 鵬 Ь obII‖5 eotymyxin e Suipnate 21c_! or-tne r types "r iri"iuii" iii, norms tor purti-ciiion of stou ," "!i.ndard strengths, o6ri i-iGZti""d to consider the above 3) This issues with the approvat of competent authority. (Shri Nirmat Kumar, Dy DGFT), Udyog Bhawan, New Delhi/Eniail: nirmat.kumar65@nic.in under secretary to the ""l3il[[:iij3i? Phone: 23323is2ter"ir, 6iGi:6lrs-ro

畿 ン4

Case No.C… 20

M/s Encee Aromatics Pvt Ltd Meeting No. l4lAM l4 dated - 24.10.2013 FNo 01/82/162/00020/AM10/DES― IH Decision: Committee considered the case as per agenda and in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/5312012-Ch. Il dated 05.082013, it was decided to ratify the norms, under Para 4.2.2 of HBP v 1 as per details given below: RA concerned may take further necessary action as per above decision of NC. Export Product Export Qty. S.No Import Item Qty. allowed ke/ke Enamber/Kephal i s/Tetrambrone l kg 1 Tricthyl Orthofollllatc 2.400 kg 3. Di Acetone Alcohol 5.720 kR

F. No. 3501 I /'t 3 At2O1 6_pt (Norms) Government of lndia Ud18:t::「Wal£ :ょ,271: Offlce Memorandum Sutte∝ f躙 郡 需:卵ri::冒177研 Hand BOOkびPЮceduЮs Ⅳdり20o"4 Case 丁his issues with the apprOva1 0f cOmpetent authOrity 義タ Under secretary tO the Governm!l詣 11品! PH:-23071162 DirectOrate Genera1 0f Foreign Trade, Depanment Of cOmmerce, 剛踏刷ゃ選駐編 Norms Recomnreru,ed_-- for 1kg Export Z-Oeoxy-Z-ttuoioZmetnyi u riO ine Щ 助く phOsphinyl―Lスlanine l_methylethyl ester

ノL '3′ ICase No.:28/17/82‐A LC4/2013,Party Name:SUVEN LIFE SCIENCES LIMITED IMeet No/Date:23/82- IALC4/2013 10603.2014 1Lic.No/Datei0910057604 118.092013 IStatus:case lApproved lDefer Date: :HQ File IRLA File |:01/82/050/00890/AM14/ |:09/24/040/00267/AM14/ 1021 Decision :ln the light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1176112013-PI(Norms) dated 04.03.2014, it was decided to ratifu norms under paru 4.7 of HBP v I as per details given below or as applied by the firm, wlrichever is less: Export product Exp. Qty. SI.No lmport items Qty.al10Wed kg/kg 3ENZHYDRYL THIOACETAMIDE Kg 1. HYDRO BROMIC ACID 1.20 2. TH10 UREA 0.45 3. BENZHYDROL 0.99 4 2‐CHLORO ACETAMIDE 0.50 may take appropriate action as per the decision of Norms Committee. Ｉ Ｌ 　 　 Ａ 一

F. No.350 I I /505 /201 3-pI (Norms) Government of India Ministry of Chemi cal & Fertilizers Department of Pharmaceuticals Udyog Bhawan, New Delhi, the 2l't October,2Ol3 Office Memorandum

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

Case of IWs Suven Life Sciencs Ltd. The undersigned is directed to refer to DGFT U.o.No. ollg2l50A5/AM14/DES- 3/15 dated the l5105/13 vide which representation from IWs. Suven Life Sciencs Ltd was sent to this Department for fixation of norms under para:4.7 forthe export of Dibenzoyl- d-Tartaric Acid. This department has examined the matter and the foilowing nonns are furnished under para 4.7 of Hand Book of procedures (vol .l) 2009-14- 2. This issues with the approval of Director (Cost). (Raj Kumar) Under Secretary to the Government of India PI-Norms (Shri R.C. Meena, Dy. DGFT), Udyog Bhawan, New Delhi. 彦 Import Item -)-Tartaric Acid _-

tプ 新 Ｆ ト ICase No.:50/14/82- IParty NamciSHREE BANKEY IMcct No/Datei1 4/82- ALC4/2013 1BEHARI LAL BOARD IALC4/2013 1MILLS 124 10.2013 ‐HQ File lRLA Flle lLic No/Date:0510364317 :01/82/050/00635/AM14/ 1:05/24/040/00195/AM14/ 10309.2013 Date: Decision: ln the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No 14010/28/2012-Ch ll dated 28 10.2013′ it was decided to ratify norms under Para 4.7 of HBP vl as per details given below or as applied by the irm′ whicheveris lessi Export product Exp.Qty S!.No. lmport items Qty. allowed MENTHOL l kg M ETA‐ CRESOL ABOVE 98.5%PURE 1 50 kg ISO PROPYL ALCOHOL 1 80 kg may take appropriate action as per the decision of Norms Committee. :

No 35011/819/2015-Pi(Norms) Government of!ndia Ministry of Chemical&Fertilizers Department of Pharmaceuticais S No lmport ltem Norms Recommended for 1kg Export 1 Azithromycin amine 1 00kg 2 Acetone 0 90kg 2 寡 Dated: 5, May2016 Office Memorandum

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

of M/s Kopran Research Labs Ltd. The undersigned is directed to refer to DGFT U.o.No. o1l}2tsot1443/AM-16/DES_ 311421 datedthe 1111116 vide which application from M/s Kopran Research Labs Ltd. was sent to this Department for fixation of norms under para.. 4.7 for the export of Azithromycin Dihydrate. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-ia:- (Rttkumar) Under Secretary to the Government oflndia PH:-23071162 Depanment Of Commerce, (Shn M V Singh,FTDO), Udyog Bhawan,New Delhi

F. No.350 I I 13 I 6t2Tt3-pI (Norms) Government of India Ministry of Chemi cal & Fertilizers Department o f pharmaceutical s Udyog Bhawan, New Delhi, the 03th July, 2Ol3 Subject:-Fixationofnormsu,o..ffiokofProcedures(Vol.l)2o0g-l4 Case of NzVs promed Exports pvt Ltd. The undersigned is directed to refer to DGFT u.o.No. ollg2l5ol1163lAML3/DEs- 311290 dated the I 8/o3l13 vide which an application from IWs. promed Exports pvt Ltd was sent to this Department for fixation of norms under para; 4.7 forthe export of lrifrin Eye Drops 25% 5ml. This department has examined the matter and the followins norms u Lutr urar[Er ano Ine lollowlng norTns are furnished under para 4.7 of Hand Book of procedures (vor .r) 2009-14:- S. No. Import Item Qty. Recommended. I 127.50mgl5ml pack This issues with tt " appi@ (Raj Kumar) Under Secretary to the Governmeni of India PI-Norms (Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi. 多 胸 ） 2.

Fo No.350H/218/2015-PI o10111lS)
｀ Goverrment oflndia ルlinistry ofChcmicalsでしFcrtilizcrs Department OfPhallllaccuticals Udyog Bhawan,Ncw Delhi, Dated the september,2015 0fflcc NIlemOrandurn SutteCt:― Fixation ofnolllls under para 4.7 0fHand B00k OFProcedures(v01.1)2009… 14 Casc Of M/s Unimax Labs Pvt Ltd. The undersigned is directed to refer tO DGFT UoO.No.01/82/50/191/Aヽ 4-16/DES-3/153 dated 難難軸嘉iFI錯職帯拗幣推澗義 撃 S.No. Import Item Qty. Recommended kg/kg. 1 Prednisolone 0.839 タ Under Secretary tO the G:ll器:」F:『ll場|: Phonc:23071162 DircctOrate Gencral ofForeign Trade, Department ofCOmmerce, (Shri M.V.Singh,FTDO), Udyog Bhawan,New Dclhi

iCaseNo■40/4/82‐ ALC4/2013 1Patt Name:KLJ I PLAS■ α ZERS LTa ‐ マ ・ ・‐ J`:|:|:::l.:__.‐・‐ ‐ ・ 2堵■ :Meet No/Date:4/82- :ALC4/2013 116052013 ILic No/Date:0510332241 :Defer Date: 122082012 1 1器星児5餅0008 νAMI″
難あ」::υ0017 VAMlン И ， Status:Case Approved IDecision:In the light of writtcn comments rcceived from Department of Chemicals and lPetrochenlicals vide their UoO no. 14010/36/2011-Ch.II dated 16.5.2013, it、 vas decided to ratify norrns under Para 4.7 of HBP v I as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Kanatol-1056 (packed rn 1277 Nos. of HM- HDPE Drums made of HM- HDPE Blowing Grade l kg 1 Phthalic Anhydride 0.425 kg 2. Sabutol 0.227 kg 3. 2-Propyl Heptanol 0.460 kg 4. HM-HDPE Drums made of HM-HDPE blowing grade Relevant, as per packing policy RA may take appropriate action as per the decision of Norms Committee.

F. No.350 I I I 46412013-pI (trtrorms) Government of India Ministry of Chemicals & Fertilizers Department of Pharmaceutical s Udyog Bhawan,New Delhi, Dated the June, 2015 Office Memorandum

Subject: - Fixation of norms under para 4.7 or Huna gook of Procedures (vol.l) 20og-14 case of M/s

Srini Pharma Ltd. . The undersigned is directed to refer to DGFT u.o.No. oll82/5011416/AM-15/DES-3/14 25 dated the l2l03ll5 vide which application from M/s. Srini Pharma Ltd was sent to this Department for fixation 9f-1orms under para: -4.7 for the export of Tadalafil. This department has examined the matter and the following norrns are fumished under para 4.7 of Hand Book oi procedures (Vol.l) 2009-14:- S. No. Import Item Qty. Recommended kg/kg. 1 I R,3 R)- 1,2,3,4 Tetrahydro-2-Chlo.o a*tyl- I (3,4-Methylenedioxyphenyl)-9H-pyrido [3,4-B] _ ndole-3 -Carboxylate (TAD40) 1.65 This issues with the approval oFDirector fpfl. (Barnali I(hastgir) Under Secretary to the Government of India Phone:23071162 (Shri M.V. Singh, FTDO), Udyog Bhawan, New Delhi 畷ζ 2.

ヱ 零 F. No.3501 ll9t5t2}l3-pt (Norms) Government of India Ministry of Chemical& Fertilizers Department of Pharmaceuticals Udyog Bhawan, New Delhi, the August,20l4 Office Memorandum

Subject:- Fixation of norms under para +.2 orHuna goa;f p.;dures (vol.l )200g-l4case of M/s Inras pharma

Ltd. The undersigned is directed to refer to DGFT U.o.No. ol/g2/50/g3g/AM-14/DES-3/9g3 dated the 06102114 vide which application from M/s. Intas Pharma Ltd was sent to this Department for fixation of norms under para: 4'7 for the export of spironolactone Tablets Bp 25 mg,50 -g rna'roo rg. This department has examinedthemafterandthefollowingnorrnsarefurnishedunder para4.7of HandBookofprocedures(vol.l) 2009-14:- S.No. Import Item For Export of 1000 NOS Tablets fqry. i, kg, 25 mgTablets 50 mg Tablets 100 mg Tablets I Spironolactone 0.0255 0.0510 0.102 2. Lactose 0.0750 0.150 0.300 3. Magnesium stearate 0.0015 0.003 0.006 4. Povidone 25 0.0018 0.0035 0.0070 く υ Poly Ethylene Glycol 400 0.0006 0.0012 0.0024 6. Pregelatinised Starch 0.0350 0.070 0.0075 0.140 0.0150 7. Purined Talc 0.0038 8. ritanium E)ioxide 0.0005 0.001 0.0019 9. lolloidial Anhydrous Silica 0.0005 0.0010 0.0020 10。 Hypromellose 0.0030 0.0060 0.0120 Sply Plain Shipper Relevant, As per packing polic1,. Thisissuesitntn@ Under secretary to the GovejYl['rffi3 Pl-Norms (Shri M.V. Singh, FTDO), Udyog Bhawan, New Delhi ハ

F. No.3 50 I I I 63 4t2O t2-pl (Norms) Government of India Ministry of Chemi cal & Fertilizers μ 2Sl ヘ Udyog Bhawan, New Delhi, the l2th March, 2Ol3 Subject:.Fixationofnormsu,o..ffiokofProcedures(Vol.l)2o0g-l4 Case of tr27s. promed Exports pvt Ltd. The undersigned is directed to refer to DGFT U.o.No. 0l/g2l50l6l4lAMl3/DES- 31778 dated the 03/07/12 vide which an application from IWs. promed Exports pvt Ltd was sent to this Department for fixatiorr of norrm under para: 4.7 for the export of Cyclomed Eye Drops L% 5ml (Net content of bulk drug=9j.593 kgs). This department has examined the matter and the following comments are furnished under para4.TofHand Book of Procedures (Vol .l) 2009-14:_ S.No. Import Item Qty. Recommended. 1 じyじlopenlolate HじL l^1_ 1__
・ .■
■ 51.0 mg per 5 ml vial This issues with th" uppr@ (NoN.Ahtta) SectiOn(Dfacer PI―Norms (Mrs. LalitaMaini, FTDO), Udyog Bhawan, New Delhi. 2.

F. No.350'1 '1l44t2016-pt (Norms) Government of lndia ' Dated: August,2016 Office Memorandum

subject - Fixation of norms under para 4.7 of Hand Book of procedures (Vor.r) 2009-14 case

of M/s Dr. Reddy Labs Ltd. ^.-^^-Tl : undersigned is directed to refer to DGFT U.o.No. 01t}2tsot1117/AM-16/DES- 3/1837 dated the 15/3/16 vide which apptication trom nlllsE. Reaoy r"o" Lto. was sent to this Department for fixation of norms under'para: +.2 ror ttte export of paricalcitol lnjection USp 2r:s]rl'5mcg/ml, 1Omcg/2mr.Smcglmtsintre dose viai, romcg/2mis;Ili#r muttiaose vial. This department has examined the matte-r and ine foilowing ;";r.;;;ir;;ished under

para 4.7 of Hand Book of procedures (Vol.l) 2009_14:_

2 (Ralkumaり Under secretary to the Government oflndia PH:-23071162 踏:朧itT躙』 [冨咆 n.adQ (shn M v singh,FttDO), Udyog Bhawan,New Delhi tr √ lmporUExport item Pancalc忙。l usP fOrexpo威。f2mcg/mlinieCIOns_ 1 21gm Paricalcitol USpfore@ 136890 nos vials Paricalcitol USP for export of t OrncglZmf , singfe dose injections- 8124 nos. vials Pancabd usP dose injections - 24OOOO nos. vials ⌒

場 ハ Casc No B‐ 96 M,/s Kairav Chemoforbe Industries Ltd ヽleeting No l1/AM 14 dated-05092013 FNo 01/82/050/00819/AM12/DES IH RLA F No 03/94/040/00413/AM12 Adv Lic No 0310646512dated04082011 ln the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/127 /2O12-Ch.ll dated 05.08.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: RA may take appropriate action as per the decision of Norms Committee. Export Product 呻 Ｑ ｕ ａ ｎ ｔ ｉ S No lmport Product Quanltv Al owed kg/kg 1.4 Dioxane 1 Mixed EthVlene Glycol 1 802 kg

F. No.350 1 1 t2SSt2O16_pt (Norms) Government of tndia Ydyog Bhawan, New Delhi, Dated; November,2016 Office Memorandum subject' - Fixation ?lngtlt under para 4.7 of Hand Book of procedures (Vol.l ) 2oog-14case of M/s Malladi Drugs & pharma"euticri= LtO. The undersigned is directed to refer to DGFT U.o.No. 01tg2tsot4o2 & 4ootAM-17/DES- 31476 & 495 dated the 23tat16 a zqrcizola' ;;'*r'i,r.., 'rpprication riom M/s Maladi Drugs & Pharmaceuticals Ltd' was sent to tnis oepartr"rt ioi'rixaiion oinorr. under para: +.2 foi tne export of (4s'5R)-(-)-4'methyt-5-phenyt'z'oxaziiainon" t"rrir"i- oxazotidinone). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of procedures (Vol.l) Z.OOg_l'i,r'v rvrrv,Yrrr! DGFT is advised to cail foilowing detairs from the firm viz: 1 Complete technical details as per Appendix_33. 2' 3Hl|.:i"#:X:1ffi;lisactual .on.Gpiion ot ar imported inputs dury certiried by 2' This issues with the approvar of competent authority. Under secretary to the o"r!TH:1,T',11:'i? PH.23323292 (Shri M.V. Singh, FTDO), Udyog Bhawan, New Delhi

F. No.350 1 1 17 0)l20t3-pl Q.,torms) Government of India New Derhi,,n. NftTrl,l,";u,? Subject:-Fixationofnormsunderou,uomProcedures(Vol.l)20og-l4CaseofM/s Agio pharma Ltd. The undersigned is directed to refer to DGFT u.o.No. 0ug2r50/545rAM-r4rDES-3/667 dated the l5ll0/13 vide which application from M/s. Agio pharmu ttd u. sent to this Department for fixation of norms under paru: 4'7 for the export of Alben-ox 2.5o/"srspnsio, 1000 mt etc., (10 Export Item). This department has examined the matter and the following nonns are fumished under para 4.7of Hand Book of Procedures (Vol.l) 2009_14:_ 紹 Export Product Import Item Albendazot"@ AlbendazOle Oral 0.102 kg Albendazote U-lus? OO ..r g 612 mg AlbendazOle bOlus 2唖 AlbendazOlc Oral AlbendazOlc bOlus 2頂万葛砥 AlbendazOle bOlus 1500 mg AlbendazOle b01us 600 mg AlbendazoteO@ mg Tablet 612 mg Albendazot" botri:OO r.rg This issues with the approval of Director (Cost). UndersecretarytOtheGoveJttIIIIm PI―Nonns (Shd R.C. Meena, Dy. DGFT), Udyog Bhawan, New Delhi S.No. Qty.recOmmended for l No. 1 Albendazole 0.0255 kg 2 ―do― 3 ― do― 4 ― do― 2550 1ng 5 10001■1 ― do¨ 0.102 kg 6 ―do― 2550 1ng 7 ¨ do― 1530 1ng 8 ―do_ 612 mg 9 ―do― 10 ¨do― 306 1ng

工 黎 Mect No/Date:1/82‐ :ALC4/2013 104.042013 :Lic.No/Date:0410143108 :06.022013 | :Decision:In the light of written commcnts rcce市 cd from Department ofChemicals andl l lPctrochenlicals vide thcir U.O No. 14010/150/2011/Ch II datcd 18.4.2012, it 、vasl 1268 decidcd to rtti″ nOrms under Para 4.7 of HBP v l as pcr dctails g市cn below or as l lRA may take appropriatc action as pcrthc dccision ofNorms Committcc l icd the llrm. whichever is less: Export Product Export Qty. SI No lmport items Qty. allowed Keydime-AKD (Alkyl Ketene Dimer- Emulsion) l kg Alkyl Ketene Dimer AKD Wax 0 100 kg 2 Solbond C40S (Emcal E6LZS) Cationic Potato Starch 0 070 kg ICase No.:1/1/82-A LC4/2013 Status:Case :Approved lDefcr Date: :HQ File :01/82/050/01359/AM13/ :RLA File 104/24/040/00245/AM13/ NamciARJUN ICHEMICALS PVT

「~ 碁 ,られyN品よЁЁStt vALしЁ IMもよNげDde2創82-1まdusCasel lCHEM PVT LttD :ALC4/2011 1Approved i 1 127092011 1 1 IHQ Fi!e lRLA F‖ e :Lic No/Date:34100303841 1 1:01/82/050/00434/AM12ノ li34/24/040/00027/AM12ノ 126052011 : | ハ__::ハ^‐ ^^^^_^:J～^月^^^^^^^～^AAA月ららnパin linh+ハf、A′ ‖十いnrハmm●nis httn「Aムハi tOecislon , , Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.140101581201'l-Ch.ll dated 23.09.2011 and in, 116:consultation with technical authorities present in meeting, decided to ratify norms under para 4.7 of ' ' '- ,HBP as per details below or as applied by firm whichever is lower:- Export product Exp. Qtv. SI No lmport items Qty. allowed Melonal l Kg 1 Methyl Heptanone 1 125 kg 2 Ethvl Chlo「o Acetate 1 201 kg 3 Sodium Methoxide 0 562 kq RA concerned may take further necessary action as per above decision of NC.

Case No:43/14/82-

IALC4/2011

ぼ ´ 矧 Party Namc:NOCIL IMcct No/Datc:1/82- 4 10042014 | 110042014 1 RLA File Lic No/Date:0310760329:Dcfcr Date: Ю3'y04υ0055″AMl″ b■122013 1 No.:142/23/82- :01/82/050/01189/AM14/ Decision : ln the light < Petrochemicals vide their ratify norms under Para r whichever is less: f written comments received from Department of Chemicals and U O No 14010/32/2012-Ch il dated l1 04 2014′ lt was decided to .7 of HBP vl as per deta‖s given below or as apphed by the firm′ Export product [xp Qty. SI・No lmport items Qty. allowed Phthalic Anyhdride (PAN) 0 614 kg ｀‐(CyC10hCxylthio)phthalimidc 3rand Namc:PILGARD PVI DICYCLOHEXYL DISULPHIDE (DCDS) 0.488 kg CAUSTIC POTASH FLAKES (Potassium Hvdroxide)rK(う Hヽ 0 233 kg may take appropriate a.tion as per the decision of Norms Committee.

F Noな 脚:1【麗i::FttirOrm→ Ministry Of chemical&Ferti‖ zers Department of Pharmaceutlcals Dated: June,2016 Office Memorandum

subject: - Fixation of norms un_der para 4.7 0t Hand Book of procedures (Vor.r) 200g_14 case

of M/s Venus Remedies Ltd. The undersigned is directed to refer to DGFT u_a Ni,. o1r82t5ot1171tAM_16/DES- 3h291 dated the 16t12115 vide whicrLippii..tiJnTrl M/s Venus Remedies Ltd. was sent to this Department for fixation ot norrs urtJ, pJ'#'+.2 r",. tt e export of ropotecan for injection 2'5mg and 4.0mg. This department n"" 6rrrin"o'itr9 matter and the foilowing norms are furnished under para 4.7 of Hand eoox ;i p;"Jril.'1vor.ty 2oO9_14:_ , Under secretary tO the Governm:i酔11品! PH:-23071162 r 粛 2 2 909mg/2 5mg vlal And 4 656mg/4 0mg vial

IParりName:DANOPHARM ICHEMICALS PRIVATE LTD 1/ 多 IMcet No/Date:7/82‐ ALC4/2015 124072015 iCase No.:259/13/82‐ IALC4/2014 Defer Date: 196 may take further action accordingly. (HQ File l:01/82/050/01262/AM15/ Export product Otv Import items Qty.kykg 4-SULPHONAMIDO PHENYL HYDRAZINE HCL ０ し し ヽ 1 SULFANILAMIDE 1.01 つ ４ SttDIUNI NITRITE 040 SODIUM BISULPHITE 1.10 4 ISO PROPYL ALCOHOL 075 5 ACTIVATED CARBON 0 100

ギ F. No.3501'1 /25 St2}16-pt (Norms) Government of lndia Dated: November.2016 Office Memorandum

subject: - Fixation of norms under para 4.7 0t Hand Book of procedures (vor.r) 2o0g-14

Case of M/s Malladi Drugs & pnarmaceuticals Ltd. The undersigned is directed to refer to DGFT U.o.No. o1t82r50t4o2 & 400/AM_ 17lDEs-3r476 & 495 dated the 23/8116 c il6noia vide which apprication from M/s Malladi Drugs & pharmaceuticars Ltd. rrr. ;;ii;il;s Department for fixation of norms under para: 4.7 for the export of (as,sn)-(-)+-me*ryi-s-pnenyr-z-or"roiiuinlni 1"t i."r oxazolidinone). This deoartment has ur)rin"JiiE'.atter and the foilowinq norms are furnished under para 4.7 of Hand eoot or procl-dri", tn"iif loir DGFT is advised to call following details from the firm viz:_

1. Complete technical details as per Appendix_33. 2 Past production vis^-d-vis actrat consumption of att imported inputs dury certified by Central Excise Authorities.

This lssues with the approval of competent authority. UndersecretarytOtheGovri‖ :||:f;lil! PH:-23323292

No.350 1 1 t2\3t20 1 6-pt (Norms) Government of lndia Dated: October, 2016 Office Memorandum

subject: - Fixation of norms under para 4.7 0t Hand Book of procedures (Vor.r) 200g_14

Case of M/s Morepen Labs Ltd. The undersigned is directed to refer to DGFT U.o.No. olt*zrsot4s,rtAM-17/DEs_ 3/450 dated the 23t8r2016 vide-which #pliirt[.i,; M/s Morepen Labs Ltd. was sent to this Department for fixation ornorms-,i,iJJr-iJn:"i,'i.l for the export of saxagriptin Hcr. This department has examinea re matieiani-tnl iorroing norms are furnished under paru 4.7 of Hand Book of procedures Uof .liZOO'g_i+--_ DGFT is advised to call following justification from the firm viz:_ Reactant Sxsor is described as trifruoro acetate sart whereas in the reaction of step-t' such trifruoro acetate is notaepicieJrirl-riil"trr". step-r reaction may be correctty elaborated and the mot. Wt. of SrSOilr;; verified. 2. Under secretary tO the Governm:i:!ン属品! PH:-23071162

エ リ F. No.350 1 1 tTg1/2015_pl Norms Government of lndia Ministry of Chemical & Flrtilizers Depa riment of pna rrn^aceutica ts Shastri Bhawan, New Delhi Dated the July 25,rO1'; Office Memorandum subjecr: .;T3,:",tI+,ffi,r:f;lj:;ni H Iilo Book of procedures (vou ) 2oos_14 The undersigned is directed^to. refer to DGFT u.o. No. 01/g2 tiosotolslolAM- ili?i".rii,i"ti,Tu:?i?isu'd,['m#:r**;Jiffi H;"I,r,r,u",,i*:", export of orristat peflets s}t,/o-wi. rnis oeprrt.i"ru.,r, ;;;;;r,:d"il"rffi*"11rjil: l"ll"*,.n norms are rurnishJil;; para 4.7 or HanJ eoo[;i,pffi#;. ffor. r) 200e_ Under secretary tO the(3overnnl:繋 :}‖li! 卜硼―鴫品糧席 3i:♀i DirectOrate(3enera1 0f Foreign Trade, Depattment Of commerce, 棚鵠罪漉編 Export ltem lmport ltem OHistaftteiiets 50%w/w 2)丁his issues with the apprOva1 0f DirectOr(Pharma industryl

F. No.350 1 1 tB2Ot2O1 s-pt (Norms) Government of lndia 次 Dated: 12May,2016 Office Memorandum subject: - Fixation -of n1m9 under para 4.7 of Hand Book of procedures (Vol.l ) 2oog-14 Case of M/s Optimus Drugs pvt. Ltd. The undersigned is directed to refer to DGFT u.o.No. 01tg2tsot1331/AM-16/DES- 311531 dated the 14t1t16 vide which ,ppii.rtl*'f;.ffi M/s optimus Drugs pvt. Ltd. was sent to this Department for fixation or ni,ims-ril";;;;, : 4..7 forthe export of Ledipasvir This department has examined the matter and the foilowing norms aie furnished under

para 4.7 of Hand Book of procedures (Vol.t) 2OOg_1+:_

Under secretary tO the(3overnm!lilツ需! PH:-23071162 (Shri M.V. Singh, FTDO), Udyog Bhawan, New Dethi Norms RecommEnded for 1kg Export (',*,aa,oa 2-a-zabicy clo (2.2.1 ) he pta n e 2 _ carb oxyl i c a ci d 1, 1 -dimethylethyl ester (6s)-6-(5-(7-b 1 H -i m id az ol2-yl 5 -aza sp i ro (2, 4) hepta n es_S carbOxy‖ c acid l,1_dirnethylきthJleξter Bislpin-olato;DiOffi 馴c‖∝0 adium(||) 0.0516kg

3メイ F. No.350t lB7t20t5_pl (Norms) Government of India Ministry of Chemicals & Fertilizers Udyog Bhawan,New Delhi, Datedthe September,20l5 Subject:-Fixationoj'n1rms;r,nj..,uffifProcedures(Vol.l)20og-l4Caseof M/s Srini pharma Ltd. The undersigned is directed to refer to DGFT U.o.No. 0r/g2r50/g33/AM-r5rDES-3/r06 dated the l9/01/15-vide ^which uppririon from M/s. uni-u* Labs pvt Ltd was sent to this Department for fixation of norms "ra". p*u : 4.7 for{re expol of Ramipril. This department has ffi[ff.1JFil?ffirTithe following norms are turnished under pirui.i or Hand Book of E)irectOrate Gcnera1 0fForcign Tradc, Department OfcOmmerce, (Shri M.V.singh,FTDO), UdyOg Bhawan,New Delhi Under%γd彎ゎ■C戚器量蹄棚 Phone:23071162 Qty. Recommena-a t gtkg '+)-Cis-endo-Z-a@ :arlboxylic acidbenzyl ester hcl ―[(lS)― ethoxy l, l'Carbonyl diirnidurG

‘ “ . No.350l U32gt20t3_pt (Norms) Government of India Udyog Bhawan. New Delhi,the24th June, 2013 Subject:-Fixation:I,iiT:',,o",,u*ffifProcedures(Vol.l)2o0g-l4Caseof IWs. Aurobindo pharma itd. The undersigned is directed to refer to DGFT u.o.No. 0r/g2/50n454/AMr3rDES-3/5r dated the 0g/04/lr iiae *hi;h;;;ppii.utio, from M/s. Aurobindo pharma Ltd was sent to this Department for fixation of norms ffi.;l:ll:4.7 forrt".*pon of Levofloxacin. This department *:.::ffi'l?$ii.",,Tfiffi:,?: "" roi[*ine norTns are rurnish"a ,na", fu.u-i.i "rHand Book or Undcr secretary,tOtheGovemll:11111‖ 11! PI―Nonns (Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi. Qty. Recom-"na"d kgZk[ floxacin CarUoxytic acia 0.8571 imethyl Sulfoxide ‐ MethyI Pip3razme ctivated Carbon As per fuel policy. This issues with the apprOval ofDirectOr(COSt).

F. No.350I II473t20t4_pI (Norms) Government of India New Delhi, ,0. 'o{;131:;t Sub:ftf,:?lffi'#derparao,ffiocedures(Vol'l)200g-14CaseofM/s. The undersigned is directed to refer to DGFT U.o.No. oug2/50/633r[Mr5/Ds-3r4g3 dated the 02/09/14 vide which an application from rralr. ar..bic pharma iia *u. sent to this Department for fixation of norms ura.r para:4.7 for the export of Telmisarian 20mg,40mg & 80mg tab' This department has examined the matter una ,rr. following comments are furnished under pala 4.7 of Hand Book of procedures (Vol.l) ZOOq_,lq:_ Tdmおarねn…f_____-20。40mg/20mgtめlet ―……………………_40.80mg/40mg tablet ――――― _____― ____― ―__81.601ng/′ 80mg tabict This issues with the approval of Director (pI). ζζh Under secretary to the ""ftffi:'rffffH1? Phone- 23071162 DirectOrate Genera1 0fFOreign Trade, Dcpartment Of cOmmerce, (Sl■ri Nllovo singh,FTDO), UdyOg Bhawan,New Delhi IA]Norllls recommended fOr Teimisartan Qty.RecOInmended kg/kg。 ―N―Propyl_4‐Methyl_6-(1_Methyl be舷lmidazole― :-yl)Benzimidazole -4-(Bromometh@ 0.87'' 0。82 kg/kg

み 48 i響1lTllll摯議ヂ:|1暑紫,TllT讐11 :HQ Fi!e RLA File lLic No/Datei0510304814: 101/82/050/00954/AM12/ :05/24/040′ 00224/AM12/ 110102011 : IDecision:Commlttee considered case as per agenda and in light of written comments fon″arded by lDepartment of C&PC vlde their U O No 14010/88/2004-Ch:‖ dated 27 1 0 2003 and in consultation lwnh technical authority presentin meeting,decided to ratify norms under para 4 7 of HBP as per detalls below or as applied by lrm whicheveris lower― Export product Exp. Qty. Si No lmport items Qtv allowed Thvmol(Puntv 98 5%Min) l Kg Meta Cresol 0 785 kg concerned may take further necessary action as per above decision of NC.

⌒ ICase No i1/28/82-ALC4/2011 1HQ File 101/82/050/00771/AM12/ Name:DEEPAK RI丁EL!MITED IRLA File 131/83/040/00065/AM12/ ILic No/Date:3110050448 120092011 Decislon i Committee considered case as per agenda and in light of written comments fon″ arded by Department of C&PC vide their U O No 14010/66/2007/Ch‖ dated 05 07 201l and in consultation technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per below or as applied by firm whichever is lower:- RA concerned may take further necessary action as per above decision of NC.

多 多 ^ i rca.e No.:24113/82- , ,ALC4t20l4 「 ・ 1満F~~ lMi五~~~ lI窒 蕊 ~ ,ppr`ved i 犠月ぶ議ζ l詰ζ揺漱鵬:Ll諦槻驚鸞識価血4攣Datc l : :Decision:ln the light of wntten cOmments received from Department of Chemicals andi l Petrochemica!s vide their u.O No.15022/14/2011-Ch.‖ dated 30.062014′ 忙was decided tol 106翡鳳 ∬‖:|[rerPan 47び HBP vl as per de面に」ven bdOW Or as ap劇たd by the nrm′ : : 1 1 norms under Para 4.7 of HBP ever is less: v1 as per details given below or as applied by the firm, Item of Export Qty S′ No Item of lmport Quantity allowed ke/ks I .3-Cyclohexanedione Resorcinol 1 12 kg Caustic Soda Flakes 0 460 kg

['( \rT F. No.350l l/69/2013-PI (Norms) Government of India Department of Pharmaceutical s Udyog Bhawan, New Delhi, the l't April, 2013 Office Memorandum

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

of IWs Torrent Pharmaceuticals Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501825/AMl3|DES-31924 dated the l4lllll2 vide which an application from M/s. Torrent Pharmaceuticals Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Valsartan Tablets USP(13 Export ltems). This department has examined the matter and the following comments are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14- 2. This issues with the approval of Director (Cost) (N.N.Ahuja) Section Officer PI-Norms (Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi. S. No. Import Item Imnort of Valsartan orooosed for lNo. Tablets 1 Valsartan Tablets 40 mg 40.8 mg 2. /alsartan Tablets 80 mg 8160 /alsartan Tablets 150 mg 163.20 y'alsartan Tablets 320 mg 3264 Amtodipine 5 mg + !al561an 160 mg Tablets 163.20 Amlodipine 5 mg + Valsartan 320 mg Tablets 326.4 Amlodipine l0 mg + Valsartan 160 mg Tablets 163.20 Amlodipine l0 mg + Valsartan 320 mg Tablets 326.4 {,mlodipine 5 mg + Valsartan 160 mg +Hydrochlorothiazide 12.5 mg 1632 A.mlodipine 5 mg + Valsartan 160 mg +Hydrochlorothiazide 25 mg 1632 ll A.mlodipine l0 mg + Valsartan 160 mg +Hydrochlorothiazide l2.5mg 163.2 {mlodipine l0 mg + Valsartan 160 mg +Hydrochlorothiazide 25 mg Amlodipine l0 mg + Valsartan 320 mg +Hydrochlorothiazide 25 mg 326.4