Government of India Ministry of Commerce and Industry Directorate General of Foreign Trade Maulana Azad Road, New Delhi 110011 Norms Committee-Ill Para 4.7 Decision Meeting No. 12/82/2016 of 2016-17 dated 28.09.2016 to consider the cases/issues under Duty Exemption Scheme {Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products and falling under Chapter 29 and 30, scheduled to be held on 28.09.2016 but actually held on 26.10.2016 under the Chairmanship of Shri J.V. Patil, Addl. DGFT in Room No.04, Udyog Bhawan, New Delhi. Following members were present:- Shri Nirmal Kumar, Dy. Director General of Foreign Trade Shri D.N.Mathur, Consultant, D/o Pharmaceuticals. The committee went through the minutes of earlier meeting No. 11/82 held 07.09.2016 and approved the same. Note: In certain cases the decision of the Norms Committee refers to the Recommendations/Observations / Deficiencies received from the concerned Technical authority in the same case or a different case of another firm with the same product. A scanned copy of such document is placed at the end of the Minutes. In some cases, the scanned copy uploaded may be unsigned. In both these instances, the scanned copy uploaded is to be accepted. The Committee does not approve SCOMET items and all applicants are understood to have furnished a declaration to RA that the items of import/export are not SCOMET items. MEETING NUMBER : 12/82-ALC4/2016 MEETING DATE : 28.09.2016 Case No.:70/4/82- ALC4/2016 Party NameiRAKSHIT DRUGS PVT LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 1 HQ File :01/82/050/00133/AM17/ RLA File :09/71/040/00061/AM12/ Lic.No/Date:0910048210 11.08.2011 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the recommendation of D/o Pharmaceuticals fonwarded vide O.M. No.35011/130/2016-PI(Norms) dated 25.10.2016 , 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 p.er decision of NC. 2 Case No.:15/2/82- ALC4/2016 Party Name:PERFECT INDUSTRIES PRIVATE LIMITED. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00015/AM17/ RLA File :03/95/040/00554/AM12/ Lie. No/Date:0310659678 14.10.2011 Defer Date:29.11.2016 Decision :Deferred. 3 Case No.:36/19/82- ALC4/2014 Party Name:ALKALI METALS LTD., Meet No/Date: 12/82- ALC4/2016 StatusiDeferred

28.09.2016 HQ File ;01/82/050/01524/AM15/ RLA File :09/24/040/00503/AM12/ Lic.No/Date:0910052125 12.04.2012 Defer Date:29.11.2016 Decision ;Deferred. 4 Case No.:38/19/82- ALC4/2014 Party Name:PORUS LABORATORIES PVT LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/01526/AMI5/ RLA File :09/24/040/00050/AM13/ Lic.No/Date:0910G52706 21.05.2012 Defer Date:29.11.2016 uecision . lechnical information has been received and sent to DoP on 19 09 2016 The Committee accordingly deferred the case. Case No.:173/5/82- ALC4/2015 Party Name;FORACE POLYMERS (P) LTD. Meet No/Date: 12/82- ALC4/2016 Status:Deferred 5 28.09.2016 HQ File :01/82/050/00313/AMl6/ RLA File :05/23/040/00069/AM14/ Lic.No/Date:0510356983 13.06.2013 Defer Date:29.11.2016 uecision :Deferred. Case No.:61/4/82- ALC4/2016 Party Name:ADCOCK INGRAM LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status;Deferred 6 HQ File ;01/82/050/00124/AM17/ RLA File :07/24/040/00097/AM14/ Lic.No/Date;0710096460 04.07.2013 Defer Date:29.11.2016 uecision ine committee decided to call for information based on the recommendation of D/o Pharmaceuticals fowarded vide O.M.No.35011/107/2016-PI{Norms) dated August 2016, uploaded at the end of these minutes and deferred the case. 1 7 Case No.:31/4/82- ALC4/2014 Party Name:UNlVERSAL BIOFUELS PRIVATE LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision luererred. 8 uase No.:41/18/82- ALC4/2013 Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., Meet No/Date:12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File 01/82/050/00854/AM14/ RLA File 07/24/040/00188/AM14/ Jc.No/Date:0710098283 16.09.2013 Defer Date:29.11.2016 Jtcisiuii. Deferred tor want ot comments from DoP. 9 Case No.;140/23/82- ALC4/2013 Party Name:UNITED PHOSPHORUS LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved HQ File :01/82/060/01187/AM14/ RLA File :03/95/040/00495/AM14/ Lie. No/Date:0310758627 21.11.2013 Defer Date: uecision . i he Committee decided to ratify norms based on the earlier decision taken by NC in its

meeting No.04/82 dated 16.05.2013 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. Case No.:116/23/82- ALC4/2013 Party Name:ALCHEM INTERNATIONAL LTD. Meet No/Date:12/82- ALC4/2016 28.09.2016 Status: Approved 10 HQ File 101/82/050/01163/AM14/ RLA File :05/23/040/00341/AM14/ Lic.No/Date:0510372635 05.12.2013 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.24/82dated 13.09.2011, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 11 Case No.:48/13/82- ALC4/2015 Party Name:BELCHEM INDS. INDIA PVT. LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File ;01/82/050/01011/AM16/ RLA File :03/94/040/00860/AM14/ Lic.No/Date:0310766718 17.01.2014 Defer Date:29.11.2016 Decision: Deferred. 12 Case No.:57/3/82- ALC4/2014 Party Name: JUBILANT LIFE SCIENCES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision iDeferred. 13 Case No.:49/13/82- ALC4/2015 Party Name:BELCHEM INDS. INDIA PVT. LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision :Deferred. 14 Case No.:237/6/82- ALC4/2014 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00639/AM15/ RLA File :17/24/040/00002/AM15/ Lic.No/Date:1710005803 05.05.2014 Defer Date:29.11.2016 Decision :Deferred. 15 Case No.:7/8/82- ALC4/2016 Party Name:MACSON PRODUCTS Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00345/AM17/ RLA File ;52/21/040/00011/AM15/ Lic.No/Date:5210041026 12.05.2014 Defer Date:29.11.2016 Decision :Deferred.

16 Case No.:13/2/82- ALC4/2015 Party NameJUBILANT LIFE SCIENCES LIMITED Meet No/Date; 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00028/AM16/ RLA File :05/23/040/00080/AM15/ Llc.No/Date:0510387607 28.05.2014 Defer Date:29.11.2016 Decision : Deferred. 17 Case No.:38/8/82- ALC4/2014 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00702/AM15/ RLA File ;09/24/040/00108/AM15/ Lie. No/Date:0910060258 28.05.2014 Defer Date:29.11.2016 Uecision : ueterred tor want of comments from DoP. 18 Case No.:165/6/82- ALC4/2014 Party Name.HALDIA PETROCHEMICALS LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 uecision :Deferred. 19 Case No.:77/8/82- ALC4/2014 Party Name:BEN20 CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date; 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File 01/82/050/00741/AM15/ RLA File 03/94/040/00196/AM15/ Lic.No/Date:0310785501 17.06.2014 Defer Date:29.11.2016 decision :Deferred. 20 Case No.:202/6/82- ALC4/2014 Party Name:FORACE POLYMERS (P) LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred ^HQ File ;01/82/050/00604/AM15/ RLA File :05/23/040/00139/AM15/ Lie. No/Date:0510389232 01.07.2014 Defer Date:29.11.2016 uecision :uererred. ' 21 Case No.:72yi0/82- ALC4/2014 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved HQ File ;01/82/050/00986/AM16/ RLA File :07/24/040/00112/AM15/ Lic.No/Date:0710105884 18.07.2014 Defer Date: ueuioiui, 1 he uommiuee decided to ratify norms based on the earlier decision taken bv NP in itc 22 Case No.:30/9/82- ALC4/2014 Party Name:SOFTGEL HEALTH CARE PVT LTD., Meet No/Date:12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00827/AM15/ RLA File :04/24/040/00033/AM15/ Lic.No/Date:0410159122 30.07.2014 Defer Date:29.11.2016

Decision : Deferred for want of comments from DoP. 23 Case No.:21/9/82- ALC4/2014 Party Name: PI INDUSTRIES LTD.. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved HQ File :01/82/050/00818/AM15/ RLA File :13/24/040/00020/AM15/ Lic.No/Date: 1310047575 12.08.2014 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O. No.15022/6/2010-Ch-ll dated 10.08.2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NO. 24 Case No.:264/13/82- ALC4/2014 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision iDeferred. 25 Case No.:255/13/82- ALC4/2014 Party NameiTHE DHARAMSl MORARJI CHEMICAL CO LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision :Deferred. 26 Case No.:263/13/82- ALC4/2014 Party Name;ANTHEA AROMATICS PVT.LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/01266/AM15/ RLA File :03/94/040/00962/AM14/ Lie. No/Date:0310788558 01.09.2014 Defer Date:29.11.2016 Decision iDeferred. 27 Case No.:217/13/82- ALC4/2014 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision : The Committee noted that information called for from the firm in NC meeting No.U2 dated 29.04.2015 is awaited. The Committee accordingly deferred the case. Case No.:6/8/82-ALC4/2014 Party Name:HONOUR LAB LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Rejected 28 HQ File :01/82/050/00670/AM15/ RLA File :09/24/040/00314/AM15/ Lic.No/Date:0910060964 12.09.2014 Defer Date: Decision : The firm has informed that said authorisation has been redeemed by RA. 1 he Committee accordingly decided to close the case.

29 Case No.:59/13/82- ALC4/2014 Party Name:HELLO PAINTS (P) LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File ;01/82/050/01062/AM15/ RLA File :05/23/040/00276/AM15/ Lic.No/Date:0510391245 19.09.2014 Defer Date:29.11.2016 Decision lueterred. 30 Case No.:9/15/82- ALC4/2014 Party Name:VIRCHOW BIOTECH PVT LTD.. Meet No/Date:12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/01296/AM15/ RLA File :09/24/040/00327/AM15/ Lic.No/Date;0910061001 19.09.2014 Defer Date:29.11.2016 HC meeting No.04/82"dated'2405^20^^ awaited. The committee accordingly deferred the case 31 Case No.:17/13/82- ALC4/2014 Party NameiGRASIM INDUSTRIES LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusrDeferred HQ File :01/82/050/01020/AM15/ Decision :Deferred. RLA File :34/24/040/00155/AM15/ Lic.No/Date:3410040570 23.09.2014 Defer Date:29.11.2016 Case No.:115/13/82- ALC4/2014 Party Name.WEST BENGAL CHEMICAL INDUSTRIES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 32 HQ File .01/82/050/01118/AM15/ RLA File :02/24/040/00097/AM15/ Lie. No/Date:0210205008 23.09.2014 Defer Date: firm whichever is less under para 4 07 of HBP Vnf 1 pf I 'P® per decision of NC. may take necessary action as 33 Case No.:74/13/82- ALC4/2014 HQ File :01/82/050/01077/AM15/ Party Name:CONSTECH ENTERPRISES PVT.LTD. RLA File ;05/23/040/00282/AM15/ Decision :Deferred. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Lie. No/Date:0510391308 24.09.2014 StatusiDeferred Defer Date:29.11.2016 Case No.:19/13/82- ALC4/2014 34 HQ File :01/82/050/01022/AM16/ Party Name;SANO MEDICAL KITS PVT LTD., Decision : Copy of application accordingly deferred the case. RLA File :04/24/040/00171/AM15/ Meet No/Date: 12/82- ALC4/2016 28.09.2016 Lie. No/Date:0410159504 29.09.2014 StatusrDeferred Defer Date:29.11.2016 has been sent to MSME for coninierTtsT^'hrCon^^ Case No.;160/13/82- ALC4/2014 35 HQ File Party Name;BAYER CROPSCIENCE LIMITED File Meet No/Date; 12/82- ALC4/2016 28.09.2016 Lic.No/Date;0310789976 Status; Rejected Defer

:01/82/050/01163/AM15/ :03/94/040/00544/AM15/ |07.10.2014 Date; Decision : The Committee noted that information called for from the firm in NO meeting No. 17/82 dated 27.01.2016 which has not been furnished by them. In absence of these information norms cannot be decided. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC. 36 Case No.:42/15/82- ALC4/2014 Party Name:PVS AGRO VET Meet No/Date:12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/01329/AM15/ RLA File :09/24/040/00246/AM15/ Lic.No/Date:0910061105 16.10.2014 Defer Date:29.11.2016 Decision : The firm has furnished requisite information vide letter dated 06.06.2016 and the same fias been sent to DoP on 04.08.2016. The Committee accordingly deferred the case. 37 Case No.:154/13/82- ALC4/2014 Party Name:GEM AROMATICS PVT. LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/01157/AM15/ RLA File :03/94/040/00680/AM15/ Lic.No/Date:0310790351 17.10.2014 Defer Date:29.11.2016 Decision iDeferred. 38 Case No.:110/13/82- ALC4/2014 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/01113/AM15/ RLA File :34/24/040/00188/AM15/ Lic.No/Date:3410040635 22.10.2014 Defer Date:29.11.2016 Decision iDeferred. 39 Case No.:86/10/82- ALC4/2014 Party Name:SHIVA PHARMAGHEM LTD, Meet N o/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision iDeferred. 40 Case No.:266/13/82- ALC4/2014 Party Name:ATUL LIMITED, Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/01269/AM15/ RLA File :08/24/040/00289/AM 15/ Lic.No/Date:0810133735 05.11.2014 Defer Date:29.11.2016 Decision iDeferred. 41 Case No.:288/13/82- ALC4/2014 Party Name:ATUL LIMITED, Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/01271/AM15/ RLA File :08/24/040/00283/AM15/ Lic.No/Date:0810133734 05.11.2014 Defer Date:29.11.2016 Decision: Deferred lease No.;107/13/82- Party Name:SHIVA Meet No/Date: 12/82- Status:Deferred

ALC4/2014 PHARMACHEM LTD, ALC4/2016 28.09.2016 HQ File :01/82/050/01110/AM15/ RLA File :34/24/040/00196/AM15/ Lic.No/Date:3410040655 05.11.2014 Defer Date:29.11.2016 uecision rueterred. 43 t^ase No.:111/13/82- ALC4/2014 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/01114/AM15/ RLA File :05/23/040/00352/AM15/ Lie. No/Date:0510391927 11.11.2014 Defer Date:29.11.2016 1... ueusiwii. Uelef red tor want ot comments from AYUSH 44 Case No.:81/18/82- ALC4/2014 Party Name.TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File 01/82/050/01427/AI/I15/ RLA File 34/24/040/00198/AM15/ Lic.No/Date:3410040676 11.11.2014 Defer Date:29.11.2016 1 L/ecision : Deferred 45 Case No.:10b/4/82- ALC4/2015 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00139/AM16/ Decision : Deferred RLA File :17/24/040/00125/AM15/ Lie. No/Date: 1710005978 12.11.2014 Defer Date:29.11.2016 46 Case No.:120/13/82- ALC4/2014 HQ File ;01/82/050/01123/AM15/ Party Name:JUBILANT LIFE SCIENCES LIMITED RLA File :05/23/040/00325/AM15/ Decision : Deferred. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred Lic.No/Date:0510391947 12.11.2014 Defer Date:29.11.2016 Case No.:65/15/82- ALC4/2014 47 HQ File :01/82/050/01352/AM15/ Party Name:ABEERS PHARMACEUTICALS PVT LTD RLA —~ 05/23/040/00360/AM15/ Decision : Deferred for want of comments from AYUSH. 48 No.:16/18/82-P^:iy ALC4/2014 C HQ File :01/82/050/01382/AM15/ HEMOFARBE industries LTD. Decision: Deferred. RLA File :03/94/040/00789/AM15/ Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred Llc.No/Date;0510392011 14.11.2014 Defer Date:29.11.2016 1 ALC4/2016 28.09.2016 Lic.No/Date:0310791300 21.11.2014 Status:Deferred Defer Date:29.11.2016 Case J 49 [-««« No.:74/18/82- ALC4/2014 Party Name:ADESHWAR MEDITEX PVT. LTD Meet No/Date: 12/82- ALC4/2016 Status; Deferred

28.09.2G16 HQ File :01/82/a50/G1440/AM15/ RLA File :G3/94/G40/GG814/AM15/ Lic.No/Date:G310791373 25.11.2014 Defer Date:29.11.2016 Decision :Deferred. 50 Case No.:18/18/82- ALC4/2014 Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date: 12/82- ALC4/2G16 28.09.2016 StatusiDeferred HQ File :01/82/G5G/01384/AM15/ RLA File :G3/94/G40/0G792/AM15/ Lic.No/Date:0310791374 25.11.2014 Defer Date:29.11.2016 Decision :Deferred. 51 Case No.:32/2/82- ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :G1/82/05G/GGG32/AM17/ RLA File :03/95/G40/G0617/AM15/ Lic.No/Date:0310791470 27.11.2014 Defer Date:29.11.2016 Decision: Deferred. 52 Case No.:92/18/82- ALC4/2014 Party NameTATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File ;01/82/05G/G1458/AM15/ RLA File :34/24/G4G/GG224/AM15/ Lic.No/Date:3410040732 28.11.2014 Defer Date:29.11.2016 Decision : Deferred. 53 Case No.:82/18/82- ALC4/2014 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :G1/82/G5G/G1448/AM15/ RLA File :G5/23/G4G/0G413/AM15/ Lic.No/Date:0510392368 10.12.2014 Defer Date:29.11.2016 Decision : Deferred for want of comments from AYUSH. 54 Case No.:101/4/82- ALC4/2015 Party NameiESTEEM INDUSTRIES PVT. LTD, Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :G1/82/050/OG14G/AM16/ RLA File :17/24/04G/G0144/AM15/ Lic.No/Date:1710005998 10.12.2014 Defer Date:29.11.2016 Decision : Deferred. 55 Case No.:97/18/82- ALC4/2D14 Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File ;G1/82/05G/01463/AM15/ RLA File :3G/24/G40/OOG41/AM15/ Lic.No/Date:3010103261 11.12.2014 Defer Date:29.11.2016 Decision : Deferred. 56 Case No.:84/18/82- ALC4/2014 Party Name:HESTER BIOSCIENCES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred

HQ File :01/82/050/01450/AM15/ RLA File :08/24/040/00362/AM15/ Lic.No/Date:0810134170 30.12.2014 Defer Date;29.11.2016 ueciston : Deferred for want of comments from DBT. 57 Case No.:151/5/82- ALC4/2015 Party Name:AGIO PHARMACEUTICALS LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ ~ File :01/82/050/00291/AM16/ RLA File :03/94/040/00902/AM15/ Lie. No/Date:0310792875 13.01.2015 Defer Date:29.11.2016 Decision : Uererrea for want of comments from DoP 58 Case No.:92/5/82- ALC4/2015 Party Name:ALKALOIDS CORPORATION Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Deferred HQ File :01/82/050/00232/AM16/ RLA File 02/24/040/00203/AM15/ Lie. No/Date:0210205448 14.01.2015 Defer Date:29.11.2016 uecjsion :Ueterredr — Case No.:59/5/82- ALC4/2015 Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 59 HQ File :01/82/050/00199/AM16/ RLA File :03/94/040/00793/AM15/ Lic.No/Date:0310792911 14.01.2015 Defer Date: Case ALC4/2014 No.:12/16/82- 60 HQ File :01/82/060/01364/AM15/ Party Name:RA PHARMA LIMITED CHEM Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved Lic.No/Date:0910061552 21.01.2015 Defer Date: RLA File :09/24/040/00592/AM15/ Case ALC4/2015 No.:8i6/5/82- 61 HQ File :01/82/050/00226/AM16/ Party Name;SENTISS PHARMA PVT. LTD. RLA File :05/24/040/00489/AM15/ Meet No/Date:12/82- ALC4/2016 28.09.2016 Status: Approved Lic.No/Date:G510392966 22.01.2015 Defer Date: of D/0 Pharmaceuticals forwarded vide OM uploaded at the end of these minutes or as aoolieri hv thi fir 1 u ^ ^ 19.11.2015, . RA concerned may take necessTrv acSon as n^r 62 Case No.:204/5/82- ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:12/82- ALC4/2016 28.09.2016 Status:Deferred 10

HQ File :01/82/050/00344/AM16/ RLA File :09/24/040/00596/AM15/ Lic.No/Date:0910061555 23.01.2015 Defer Date:29.11.2016 Decision : Deferred for want of comments from DoP. 63 Case No.:230/5/82- ALC4/2015 Party Name:R.K.!NDUSTRIES, Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00370/AM16/ RLA File :08/24/040/00394/Ai/l15/ Lic.No/Date:0810134414 28.01.2015 Defer Date:29.11.2016 Decision :Deferred. 64 Case No.:91/7/82- ALC4/2015 Party Name:SHREE GANESH REMEDIES PVT. LTD. Meet No/Date:12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision :Deferred. 65 Case No.:52/19/82- ALC4/2014 Party Name:PCL OIL & SOLVENTS LTD.. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/01540/AM15/ RLA File ;05/24/040/00273/AM15/ Llc.No/Date:0510393248 17.02.2015 Defer Date:29.11.2016 Decision:Deferred. Case No.:38/7/82- ALC4/2015 Party Name:AUROBlNDO PHARMA LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 66 HQ File :01/82/050/00643/AM16/ RLA File :09/24/040/00640/AM15/ Lic.No/Date:0910061628 18.02.2015 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.35011/662/2012-Pi{Norms) dated 12.03.2013 , of HBP Vol.1. RA concerned may take necessary action as per decision of NO. Case No.:280/5/82- ALC4/2015 Party Name:FERMENTA BIOTECH LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred 67 HQ File :01/82/050/00420/AM16/ RLA File :03/94/040/01110/AM15/ Lic.No/Date:0310794101 24.02.2015 Defer Date:29.11.2016 Decision : Information called for from the firm in NO meeting No.06/82 dated 14.05.2016 is awaited. The Committee accordingly deferred the case. Case No.:444/5/82- ALC4/2015 Party Name;AARTl INDUSTRIES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred 68 HQ File :01/82/050/00584/AM16/ RLA File :03/94/040/01132/AM15/ Lic.No/Date:0310794412 09.03.2015 Defer Date;29.11.2016 11

69 70 Case No.:10S/7/82- ALC4/2015 Party Name:ALCHEMIE LABORATORIES Meet No/Dat0:12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00711/AIVl16/ RLA File :03/94/040/00812/AM15/ Lic.No/Date:0310794612 16.03.2015 Defer Date:29.11.2016 uecision : Deferred tor want of comments from DoP. Case No.:43'l/5/82- ALC4/2015 Party Name;EUROLIFE HEALTHCARE PVT. LTD. Meet No/Date:12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00571/AM16/ RLA File :03/94/040/01086/AM15/ Lic.No/Date:0310794964 27.03.2015 Defer Date:29.11.2016 uBuibion . information called tor firm in NO meeting No.20/82 dated 09.03.2016 is awaited The Committee accordingly decided to await the reply and deferred the case Case No.:58/4/82- ALC4/2015 Party Name:SOFTGEL HEALTH CARE PVT. LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 71 HQ File :01/82/050/00097/AM16/ RLA File :04/24/040/00303/AM15/ Lic.No/Date:0410160408 10.04.2015 Defer Date: Ph=rm"" 'r'T 'he recommendation of D/o tt'if ^"'® OI'^hJo-^SOII/aiacOIS-PKNorms) dated November 2015 Thbp Vol V "'® whichever is iess under para 4.07 Of HBP Vol.1. RA concerned may take necessary action as per rier.iQinn nf mc 1 Case No.:59/4/82- ALC4/2015 Party Name:SOFTGEL HEALTH CARE PVT. LTD., Meet No/Date:12/82- ALC4/2016 28.09.2016 Status: Approved 72 HQ File •01/82/050/00098/AM16/ H'-A File |Lic.No/Date:0410160407 04/24/040/00333/AM15/ |l0.04.2015 Defer Date: 73 74 Case No.:60/4/82- ALC4/2015 Party Name:SOFTGEL HEALTH CARE PVT. LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved HQ File :01/82/050/00099/AM16/ RLA File :04/24/040/00334/AM15/ Lie. No/Date:0410160406 10.04.2015 Defer Date: Pfiarmaceuticals fcnvardervidroM^o 3501^1/^^ /^^n^hisndation of D/o Case No.;22/4/82- Pariw Mor««.or^r-T^«-. 77-— HQ File :01/82/050/00061/AM16/ HEALTH LTD., CARE PVT. RLA Pile :04/24/040/00335/AM15/ |Decision : Deferred for want of comments from DoP. ALC4/2016 28.09.2016 Lie. No/Date:0410160421 20.04.2015 StatusiDeferred Defer Date:29.11.2016 12

75 Case No.:50/7/82- ALC4/2015 Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:12/82- ALC4/2016 28.09.2016 Status;Deferred HQ File :01/82/050/00655/AI/l16/ RLA File :09/24/040/00041/AM16/ Lic.No/Date:0910061976 06.05.2015 Defer Date:29.11.2016 Decision : Information called for from the firm in NC meeting No.19/82 dated 25.2.2016 Is awaited. The Committee deferred the case. Case No.:3/3/82-ALC4/2015 Party Name:RA CHEM PHARMA LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 76 HQ File :G1/82/050/00033/AM16/ RLA File :09/24/040/00G77/AM16/ Lic.No/Date:0910061994 07.05.2015 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.23/82 dated 06.03.2014 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.committee accordingly deferred the case. 77 Case No.:15/7/82- ALC4/2015 Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision iDeferred. 78 Case No.:129/7/82- ALC4/2015 Party Name:NATIONAL TUBE INDUSTRIES, Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision : A set of application has been sent to MSME for comments and deferred the case. 79 Case No.:164/7/82- ALC4/2015 Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00769/AM16/ RLA File :03/94/040/00026/AM16/ Llc.No/Date:0310795971 18.05.2015 Defer Date:29.11.2016 Decision : Information received and sent to DoP for comments. 80 Case No.:133/7/82- ALC4/2015 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved HQ File :01/82/050/00738/AM16/ RLA File :03/94/040/00085/AM16/ Lic.No/Date:0310796048 20.05.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation ot u/o Pharmaceuticals forwarded vide O.M.No.35011/220/2016-PI(Norms) dated 21.10.2016, 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. 81 Case No.:102/7/82- Party Name:DYNAMIC Meet No/Date: 12/82- Status:Deferred ALC4/2015 SPECIALITY ALC4/2016 13

CHEMICALS LIMITED 28.09.2016 HQ File :01/82/050/00707/AM16/ RLA File :30/24/040/00006/AM16/ Lic.No/Date:3010103498 2105.2015 Defer Date:29.11.2016 Decision :Deferred. 82 Case No.:55/'l3/82- ALC4/2015 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision :Deferred. 83 Case No.:176/7/82- ALC4/2015 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Rejected HQ File :01/82/050/00781/AM16/ RLA File :03/94/040/00124/AM16/ Lic.No/Date:0310796194 26.05.2015 Defer Date: uectston : The Committee noted that information was called for from the firm by NC in its meeting No.21/82 dated 23.3.2016 but reply has not been received so far. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC. 84 Case No.:124/7/82- ALC4/2015 Party Name:PRIVI ORGANICS LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusrDeferred HQ File :01/82/050/00729/AM16/ RLA File :03/95/040/00114/AM16/ Lic.No/Date:0310796233 27.05.2015 Defer Date:29.11.2016 uecision :Deferred. 85 Case No.:100/7/82- ALC4/2015 Party Name:SHREE GANESH REMEDIES PVT.LTD. Meet No/Date:12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00705/AM16/ RLA File :34/24/040/00024/AM16/ Lic.No/Date:3410041261 28.05.2015 Defer Date:29.11.2016 uecision lUeterred. 86 Case No.:188/7/82- ALC4/2015 Party Name:ATUL LIMITED. Meet No/Date:12/82- ALC4/2016 28.09.2016 Status:Approved HQ File :01/82/050/00793/AM16/ RLA File :08/24/040/00034/AM16/ Lie. No/Date:0810135421 02.06.2015 Defer Date: uecision . ine Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded in earlier vide U.O. No.14010/16/2015-Ch-ll dated 10.11.2015, 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. 87 ALCMram-: Party Name:GLOBE Meet No/Date: 12/82- Status: ALC4/2015 TROTTERS PVT LTD ALC4/2016 14

28.09.2016 HQ File :01/82/050/00747/AM16/ RLA File :03/94/040/00159/AM16/ Lic.No/Date:0310796401 03.06.2015 Defer Date: Decision : The Committee noted that information was called for from the firm by NO in its meeting No.21/82 dated 23.3.2016 but reply has not been received so far. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC. 88 Case No.:110/7/82- ALC4/2015 Party Name:RISHABH METALS & CHEMICALS PVTLTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision :Deferred. 89 Case No.:17/7/82- ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00622/AM16/ RLA File :05/24/040/00078/AM16/ Lic.No/Date:0510394418 03.06.2015 Defer Date:29.11.2016 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. 90 Case No.:67/7/82- ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00672/AM16/ RLA File :09/24/040/00105/AM16/ Lic.No/Date:0910062138 05.06.2015 Defer Date:29.11.2016 Decision : Information called for from the firm in NC meeting No.21/82 dated 22.03.2016 is awaited. The Committee accordingly defer the case. 91 Case No.:80/4/82- ALC4/2016 Party Name:ADCOCK INGRAM LTD, Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision : The committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/107/2016-PI{Norms) dated August 2016, uploaded at the end of these minutes and deferred the case. 92 Case No.:66/7/82- ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision iDeferred. 93 Case No.:159/7/82- ALC4/2015 Party Name:VIJAY PERFUMES PVT.LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File RLA File Lie. No/Date;0310796576 Defer 15

:01/82/050/00764/AMl6/ :03/95/040/00985/AM15/ 11.06.2015 Date;29.11.2016 Decision :Deferred. 95 Case No.:42/13/82- ALC4/2015 Party Name:BTL EXPORTS PVT. LTD.. Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 ico^ii.nici.uauuii u( u/u rnarmaceuticais forwarded vide ™ 08.09.2016 decided to call for following Information

1. Copy of valid drug manufacturing license for the export product with approved corn position. wastage In one application and 22% wastage In another application Justification for such variation may be furnished.
2. Firm has shown use of 50 liters of stearyl alcohol with 1000kg ascorbic acid In flow certificate, It Is shown as 1:1 by content of stearyl alcohol In export product may be furnished.
3. CoATTest report of the export product vis-a-avis specification given in British Pharmacopoeia may be furnished.
4. Past Prod^tion vis-a-vis actuai consumption of import item duly certified by Central Excise Authorities may be furnished. The Committee accordingly deferred the case. 96 Case No.:48/19/82- ALC4/2015 Party NameiRAJ DHANVANTRY PHARMACY Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 ueuision lUeterred. 97 Case No.:41/13/82- ALC4/2015 Party NameiDANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/01004/AM16/ RLA File :03/94/040/00111/AM16/ Lie. No/Date:0310796667 16.06.2015 Defer Date:29.11.2016 uecisiun lUeterred. 98 Case No.:52/7/82- ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred 16 Case No.:87/7/82- ALC4/2015 Party Name:VISION DRUGS PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status; Approved 94 HQ File ;01/82/050/00692/AMI6/ RLA File :09/24/040/00102/AM16/ Lic.No/Date:0910062168 11.06.2015 Defer Date: Decision . The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/759/2015-PI(Norms) dated April 2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol. 1. RA concerned may take necessary action as per decision of NC.

HQ File :01/82/050/00657/AM16/ RLA File :05/23/040/00107/AM16/ Lic.No/Date:0510394590 17.06.2015 Defer Date:29.11.2016 Decision : DML called for from the firm is awaited. The Committee accordingly deferred the case. 99 Case No.:43/13/82- ALC4/2015 Party ' Name;BTL EXPORTS PVT. LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/01006/AM16/ RLA File :03/94/040/00178/AI/l16/ Lic.No/Date:0310796712 18.06.2015 Defer Date:29.11.2016 Decision :Deferred. 100 Case No.:15/9/82- ALC4/2015 Party Name:KDAC CHEM PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00951/AM16/ RLA File :34/24/040/00069/AM16/ Lic.No/Date:3410041310 22.06.2015 Defer Date:29.11.2016 Decision :Deferred. 101 Case No.:83/13/82- ALC4/2015 Party Name:RIDDHI PHARMA Meet No/Date; 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/01046/AM16/ RLA File :34/24/040/00087/AM16/ Lic.No/Date:3410041313 23.06.2015 Defer Date:29.11.2016 Decision : Deferred.. 102 Case No.:75/7/82- ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00680/AM16/ RLA File :05/24/040/00122/AM16/ Lic.No/Date:0510394696 25.06.2015 Defer Date:29.11.2016 103 Case No.:78/7/82- ALC4/2015 Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED Meet N o/Date; 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00683/AM16/ RLA File :02/24/040/00028/AM16/ Lic.No/Date:0210205920 25.06.2015 Defer Date:29.11.2016 Decision : The Committee noted that information called for from the firm in NC meeting No.19/82 dated 25.02.2016 is awaited. The Committee accordingly deferred the case. 104 Case No.:108/14/82- ALC4/2015 Party Name:VlVIMED LABS LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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;29.11.2016 105 Case No.:10/13/82- ALC4/2015 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred 17

HQ File :01/82/050/00973/AM16/ RLA File :03/94/040/00229/AM16/ Lic.No/Date:0310797018 02.07.2015 Defer Date:29.11.2016 Decision :Deferrecl. 106 Case No.:11/13/82- ALC4/2015 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00974/AM16/ RLA File :03/94/040/00228/AM16/ Lic.No/Date:0310797020 02.07.2015 Defer Date:29.11.2016 ueciston ;Deferred. 107 Case No.:24/13/82- ALC4/2016 Party Name:DANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Uecision : Deferred. Case No.:82/13/82- ALC4/2015 Party Name:PAB^ ORGANICS PVT.LTD, Meet No/Date; 12/82- ALC4/2016 28.09.2016 Status: Rejected lOR HQ File :01/82/050/01045/AM16/ RLA File :34/24/040/00084/AM16/ Lic.No/Date:3410041360 07.07.2015 Defer Date: Ueuibion . Ihe uommittee noted that information has been called for from the firm by NC in its meeting No.15/82 dated 30.12.2015 but reply has not been received so far. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC. ^ 109 Case No.:20/16/82- ALC4/2015 Party Name;MYLAN LABORATORIES LIMITED Meet No/Date:12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/01340/AM16/ RLA File ;09/24/040/00032/AM16/ Lic.No/Date:0910062338 15.07.2015 Defer Date:29.11.2016 No.06/82 dated 14.05 2016 is awaited. The Committee accordingly deferred the case Case No.:22/13/82- ALC4/2015 Party Name: BLISS INDASI LIFESCIENCES PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusrDeferred 110 HQ File :01/82/050/00985/AM16/ RLA File ;03/94/040/00282/AM16/ Lie. No/Date:0310797355 17.07.2015 Defer Date:29.11.2016 uec ston ; I he oommittee noted that information had been called for from repfy an'd d°efer^d the to await the 111 Case No.;115/13/82- ALC4/2015 HQ File Party Name:FERMENTA BIOTECH LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 RLA File |Llc.No/Date:0310797627 StatusrDeferred Defer 18

:01/82/050/01078/AM16/ :03/94/040/00038/AM16/ 24.07.2015 Date:29.11.2016 Decision : Information called for from the firm in NC meeting No.06/82 dated 14.05.2016 is Case No.:79/8/82- ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 112 HQ File ;01/82/050/00875/AM16/ RLA File :05/24/040/00110/AM16/ Lic.No/Date:0510395084 24.07.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/129/2016-PI(Norms) dated 18.07.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NO. 113 Case No.:73/8/82- ALC4/2015 Party Name;RECKITT BENCKISER HEALTHCARE INDIA LIMITED Meet N o/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 114 Case No.:116/13/82- ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision iDeferred. Case No.:114/13/82- ALC4/2015 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 115 HQ File :01/82/050/01077/AM16/ RLA File :03/94/040/00258/AM16/ Llc.No/Date:0310797898 03.08.2015 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based earlier decision taken by NC in its meeting No.06/82 dated 29.08.2014, uploaded at the end of these minutes or as 116 Case No.:112/13/82- ALC4/2015 Party Name:K V AROCHEM PVT. LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision :Deferred. 117 Case No.:109/13/82- ALC4/2015 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File RLA File Lie. No/Date:0310797954 Defer 19

:01/82/050/01072/AM16/ |:03/94/040/00170/AM16/ |05.08.2015 |Date;29.11.2016 information called for from the firm in NC meeting No"^ dated 14.06.2016 is awaited. The Committee accordingly decided to await the reply and deferred tne case. 118 119 Case No.:12/18/82- ALC4/2015 Party Name;OMTECH CHEMICAL INDUSTRIES PVT.LTD. Meet No/Date:12/82- ALC4/2016 28.09.2016 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:29.11.2016 uecision : Deterred. — Case No.:50/13/82- ALC4/2015 Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/01013/AM16/ RLA File 04/24/040/00095/AM16/ Lie. No/Date:0410160884 06.08.2015 Defer Date:29.11.2016 120 Case No.:2/21/82- ALC4/2015 Party Name:AUROLAB Meet No/Date:12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/01707/AM16/ RLA File :35/24/040/00022/AM16/ Lic.No/Date:3510044782 06.08.2015 Defer Date:29.11.2016 ueuision : uererreci tor want of comments from DoP 121 Case No.:111/13/82- ALC4/2015 HQ ~ ^ :01/82/050/01074/AM16/ Dectsion :Deferred» Party Name.HEMA DYE CHEM PVT. LTD. RLA File :03/94/040/00305/AI/I16/ Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred Lic.No/Date:0310798134 13.08.2015 Defer Date:29.11.2016 122 Case No.:127/13/82- ALC4/2016 HQ File :01/82/050/01090/AM16/ Party Name.ASTEC LIFESCIENCES LTD. iDeclsion :D^erred for want of RLA File :03/94/040/00878/AM15/ Meet No/Date: 12/82- ALC4/2016 28.09.2016 Lic.No/Date:0310798205 17.08.2015 comments from DoP. Status:Deferred Defer Date:29.11.2016 123 Case No.:128/13/82- ALC4/2015 HQ File :01/82/050/01089/AM16/ Party Name.ASTEC LIFESCIENCES LTD., RLA File :03/94/040/00879/AM15/ Meet No/Date: 12/82- ALC4/2016 28.09.2016 Lic.No/Date:0310798319 20.08.2015 Status:Deferred Defer Date:29.11.2016 124 Case No.:61/13/82- ALC4/2015 Party Name.JODAS EXPOIM PVT.LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred 20

HQ File :01/82/050/01024/AM16/ RLA File :05/23/040/00218/AM16/ Lic.No/Date;0510395388 20.08.2015 Defer Date;29.11.2016 Decision : Information called for from the firm in NC 08/82 dated 27.07.2016 is awaited. The Committee accordingly deferred the case. • 125 Case No.:161/13/82- ALC4/2015 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision:Deferred. 126 Case No.:77/13/82- ALC4/2015 Party Name:ARKRAY HEALTHCARE PVT.LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision : Information called for from the firm in NC 10/82 dated 23.08.2016 is awaited. The Committee accordingly deferred the case. Case No.:120/13/82- ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 127 HQ File :01/82/050/01083/AM16/ RLA File :03/94/040/0G279/AM16/ Lic.No/Date:0310798629 03.09.2015 Defer Date: Pharmaceuticals forwarded vide 0.M.No.35011/783/2015-PI(Norms) dated 14.07.2016, of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 128 Case No.:84/14/82- ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD.. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/01220/AM16/ RLA File :05/24/040/00262/AM16/ Lic.No/Date:0510395506 03.09.2015 Defer Date:29.11.2016 Decision : The Committee noted that information called for from the firm in NC meeting No.06/82 dated 24.05.2016 is awaited. The Committee accordingly deferred the case. 129 Case No.:59/4/82- ALC4/2016 Party Name:ADCOCK INGRAM LTD, Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00122/AM17/ RLA File :07/24/040/00180/AM16/ Lic.No/Date:0710108694 07.09.2015 Defer Date:29.11.2016 Decision : The committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/107/2016-Pl(Norms) dated August 2016, uploaded at the end of these minutes and deferred the case. 130 Case No.:8/9/82- ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date; 12/82- . ^LC4/2016 28.09.2016 Status:Approved HQ File RLA File Lic.No/Date:3410041496 Defer Date: 21

:01/82/050/00944/AM16/ :34/24/040/00155/AM16/ (39.09.2015 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 19.09.2013, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take 131 Case No.:10/9/82- ALC4/2015 Party Name:ALKYL AMINES CHEMICALS LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00946/AM16/ RLA File :03/94/040/00355/AM16/ Llc.No/Date:0310798806 10.09.2015 Defer Date:29.11.2016 Case No.:51/19/82- ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 13? HQ File :01/82/050/01532/AM16/ RLA File :03/95/040/00430/AM16/ Lic.No/Date:0310799076 28.09.2015 Defer Date: Dwui5,iori . Ihe uommittee decided to ratify norms on repeat basis based on the D/o Pharmaceuticals forwarded vide O.M. No.35011/815/2015-PI{Norms) tess unde? DarT4 07 of°HRP v i a® aPPlied by the firm whichever is tess under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of 133 Case No.:8/16/82- ALC4/2015 Party Name.VIVIMED LABS LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File ;01/82/050/01328/AM16/ RLA File :09/24/040/00294/AM16/ Lic.No/Date;0910062666 28.09.2015 Defer Date:07.09.2016 Decision :Ueterred. 134 Case No.:12/19/82- ALC4/2015 HQ File :01/82/050/01492/AM16/ Party Name:ARJUN CHEMICALS PVT. LTD.; RLA File :04/24/040/00154/AM16/ Decision :Deferred. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Lie. No/Date;0410161070 01.10.2015 Status: Deferred Defer Date:29.11.2016 135 Case No.:44/4/82- ALC4/2016 HQ File :01/82/050/00107/AM17/ Dectslon :Deferred. Party Name:KUBO COMBUSTION EFFICIENCY CHEMICALS PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred RLA File :03/94/040/00468/AM16/ Lic.No/Date;0310799183 05.10.2015 Defer Date:29.11.2016 136 Case No.:130/14/82- ALC4/2015 HQ File :01/82/050/01266/AM16/ Party Name:V.D.H ORGANICS PVT. LTD RLA File ;05/24/040/00317/AM16/ Meet No/Date: 12/82- ALC4/2016 28.09.2016 Lie. No/Date:0510395874 09.10.2015 StatusiDeferred Defer Date:29.11.2016 22

Decision :Deferred. 137 Case No.:56/2/82- ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED. Meet N o/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00056/AM17/ RLA File ;07/24/040/00123/AM16/ Lic.No/Date:0710108886 13.10.2015 Defer Date:29.11.2016 Decision :Deferred. 138 Case No.:135/13/82- ALC4/2015 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision : Copy of application has been sent to DoP. 139 Case No.:24/16/82- ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/05G/01344/AM16/ RLA File :09/24/040/00380/AM16/ Lic.No/Date;0910062727 14.10.2015 Defer Date:29.11.2016 Decision :Deferred. 140 Case No.:136/13/82- ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Deferred HQ File :01/82/050/01099/AI/l18/ RLA File :08/24/040/00207/AM16/ Llc.No/Date:0810136320 16.10.2015 Defer Date:29.11.2016 Decision iDeferred. 141 Case No.:77/16/82- ALC4/2015 Party Name:LACTOSE (INDIA) LTD.. Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/01397/AM16/ RLA File :03/95/040/00481/AM16/ Lic.No/Date:0310799561 20.10.2015 Defer Date:29.11.2016 Decision : Information called for from the firm in NO meeting No.08/82 dated 27.07.2016 is 142 Case No.:140/13/82- ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:12/82- ALC4/2016 28.09.2016 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:29.11,2016 Decision :Deferred. 143 Case No.:141/13/82- ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File RLA File Uc.No/Date:0310799629 Defer 23

:01/82/Q50/01104/AM16/ :03/95/040/00504/AM16/ 23.10.2015 Date:29.11.2016 Decision :Deferred. 144 Case No.:73/19/82- ALC4/2015 Party Name:GALAXY SURFACTANTS LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusrOeferred HQ File :01/82/050/01554/AM16/ RLA File :03/94/040/00575/AM16/ Lic.No/Date:0310799849 29.10.2015 Defer Date:29.11.2016 Decision :Deferred. 145 Case No.:147/13/82- ALC4/2015 Party NameiGOPINATH CHEM-TECH LTD., Meet No/Date:12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/01110/AM16/ RLA File :08/24/040/00241/AM 16/ Llc.No/Date:0810136382 29.10.2015 Defer Date:29.11.2016 Decision :Deferred. 146 Case No.:64/19/82- ALC4/2015 Party Name;!NDO AMINES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusrOeferred HQ File ;01/82/050/01545/AIVl16/ RLA File :03/94/040/00240/AM16/ Lic.No/Date:0310799907 30.10.2015 Defer Date:29.11.2016 Decision iDeterred. — 147 Case No.:66/19/82- ALC4/2015 Party Name:INDO AMINES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 1"Liecisiuii :Ueterred. Case No.:153/13/82- ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 148 HQ File :01/82/050/01116/AM16/ RLA File :34/24/040/00199/AM16/ Lie. No/Date:3410041644 02.11.2015 Defer Date: Decioiuii 1 he Cummmee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.04/82 dated 12.06.2015, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vo!.1 RA concerned mav take concerned may take 149 Case No.:68/19/82- ALC4/2015 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:12/82- ALC4/2016 28.09.2016 StatusrDeferred HQ File :01/82/050/01547/AM16/ RLA File :03/94/040/00582/AM16/ tic. No/Date:0310799943 02.11.2015 Defer Date:29.11.2016 Decision :Deferred. 160 Case ALC4/2015 No.:54/19/82- Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date; 12/82- ALC4/2016 Status: Approved 24

28.09.2016 HQ File :01/82/050/01535/AM16/ RLA File :03/94/040/00590/AM16/ Lic.No/Date:0310799952 02.11.2015 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.35011/854/2015-PI(Norms) dated 08.09.2016 , 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 NO. 151 Case No.:156/13/82- ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/01119/AM16/ RLA File :09/24/040/00464/AM16/ Lic.No/Date:0910062832 03.11.2015 Defer Date:29.11.2016 152 Case No.:38/21/82- ALC4/2015 Party Name:VINS BIOPRODUCTS LTD.. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Deferred HQ File :01/82/050/01743/AI/!16/ RLA File :09/24/040/00442/AM16/ Lic.No/Date:0910062831 03.11.2015 Defer Date:29.11.2016 Decision : Deferred for want of comments from DBT. 153 Case No.:159/13/82- ALC4/2015 Party Name:CHEMCON SPECIALITY CHEMICALS P LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/01122/AM16/ RLA File :34/24/040/00205/AM16/ Lic.No/Date:3410041650 04.11.2015 Defer Date:29.11.2016 Decision iDeferred. 154 Case No.:57/19/82- ALC4/2015 Party Name: BAYER CROPSCIENCE LIMITED Meet No/Date:12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/01538/AM16/ RLA File :03/94/040/00443/AM16/ Lic.No/Date:0310800060 05.11.2015 Defer Date:29.11.2016 Decision :Deferred. 155 Case No.:18/21/82- ALC4/2015 Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/01723/AI/116/ RLA File :09/24/040/00487/AM16/ Lic.No/Date:0910062841 06.11.2015 Defer Date:29.11.2016 Decision ;Deferred. 156 Case No.:23/21/82- ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/01728/Ai/l16/ RLA File :09/24/040/00481/AM16/ Lic.No/Date:0910062849 10.11.2015 Defer Date:29.11.2016 25

Decision : Information called for from the firm in NC meeting No.06/82 dated 14.06.2016 is 157 Case No.:165/13/82- ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision :Deferred. 158 Case No.:71/19/82- ALC4/2015 Party Name;AVA CHEMICALS PVT.LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/01552/AM16/ RLA File :03/94/040/00613/AM16/ Llc.No/Date:0310800272 17.11.2015 Defer Date;29.11.2016 Decision :Deferred. 159 Case No.:72/1l9/82- ALC4/2015 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision :Deferred. Case No.:167/13/82- ALC4/2015 Party Name:ALIROBINDO PHARMA LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 160 HQ File :01/82/050/01130/AM16/ RLA File :09/24/040/00493/AM16/ Lic.No/Date:0910062862 19.11.2015 Defer Date: uectsion . The Committee decided to ratify norms on repeat basis based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/860/2015-PI(Norms) dated 17.10.2016 , uploaded at the end of these minutes or as applied by the firm whichever is tess under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of 161 Case No.:58/19/82- ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File .01/82/050/01539/AIVI16/ RLA File :03/94/040/00572/AM16/ Lic.No/Date:0310800324 19.11.2015 Defer Date:29.11.2016 ueciston rueterred. 162 Case No.:75/19/82- ALC4/2015 Party Name:BEN20 CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date; 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/01556/AM16/ RLA File :03/94/040/00450/AM16/ Lic.No/Date:0310800347 20.11.2015 Defer Date:29.11.2016 Decision :Deferred. — I

—^ 163 Dase No.:60/19/82- Party Name:ELPPE [Meet No/Date-12/82- StatusiDeferred 26

ALC4/2015 CHEMICALS PRIVATE LIMITED ALC4/2016 28.09.2016 HQ File :01/82/050/01541/A[VI16/ RLA File :03/94/040/00661/AM16/ Lic.No/Date:0310800340 20.11.2015 Defer Date:29.11.2016 Decision iDeferred. 164 Case No.:20/19/82- ALC4/2015 Party Name:VDH CHEM TECH PVT. LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision :Deferred. Case No.:59/19/82- ALC4/2015 Party Name:EXCEL INDUSTRIES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision :Deferred. 165 166 Case No.:62/19/82- ALC4/2015 Party Name:EXCEL INDUSTRIES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusrDeferred HQ File :01/82/050/01543/AM16/ RLA File :03/94/040/00252/AM16/ Lic.No/Date:0310800539 01.12.2015 Defer Date:29.11.2016 Decision :Deferred. 167 Case No.:61/19/82- ALC4/2015 Party Name;K V AROCHEM PVT. LTD Meet No/Date:12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision :Deferred. 168 Case No.:81/19/82- ALC4/2015 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:12/82- ALC4/2016 28.09.2016 Status: Approved HQ File :01/82/050/01562/AM16/ RLA File :03/94/040/00660/AM16/ Lic.No/Date:0310800594 02.12.2015 Defer Date; recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/858/2015-PI(Norms) dated 08.09.2016 . uploaded at the end of these minutes or as applied by the firm whichever is NC. 169 Case No.:16/19/82- ALC4/2015 Party Name:JUBILANT GENERiCS LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved HQ File :01/82/050/01496/AM16/ RLA File :05/23/040/00362/AM16/ Lic.No/Date:0510396503 03.12.2015 Defer Date: 27

recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/842/2015-PI(Norms) dated 06.09.2016 , uploaded at the end of these minutes or as applied by the firm whichever is NO. 170 Case No.:17/19/82- ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/01497/AM16/ RLA File :05/23/040/00002/AM16/ Lic.No/Date:0510396500 03.12.2015 Defer Date:29.11.2016 Decision ;Deferred. 171 Case No.:1/8/82- ALC4/2016 Party Name:SWATI MENTHOL & ALLIED CHEMICALS LTD.. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00339/AM17/ RLA File :29/24/040/00007/AM16/ Lie. No/Date:2910025232 04.12.2015 Defer Date:29.11.2016 Decision :Deferred. 172 Case No.:90/'J9/82- ALC4/2015 Party Name;VENLIS REMEDIES LTD.. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/01571/AM16/ RLA File :22/24/040/00082/AM16/ Lic.No/Date:2210015359 07.12.2015 Defer Date:29.11.2016 Decision :Deferred for want of comments from DBT. Case No.:84/4/82- ALC4/2016 Party Name;ETERNIS FINE CHEMICALS LIMITED, Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 173 HQ File :01/82/050/00127/AM17/ RLA File :03/94/040/00671/AM16/ Lie. No/Date:0310800767 08.12.2015 Defer Date: Decision . 1 ne Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.04/82 dated 16.05.2013 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned mav take 174 Case No.:40/19/82- ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:12/82- ALC4/2016 28.09.2016 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;29.11.2016 Decision lueterred. 175 Case No.:88/19/82- ALC4/2015 Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/01569/AM16/ RLA File :22/24/040/00081/AM16/ Lie. No/Date:2210015365 10.12.2015 Defer Date:29.11.2016 Decision .Deterred ror want of comments from DoP. 28

176 Case No.:94/19/82- ALC4/2015 Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File ;01/82/050/01575/AM16/ RLA File :22/24/040/00080/AM16/ Llc.No/Date:2210015366 10.12.2015 Defer Date:29.11.2016 Decision :Deferred for want of comments from DoP. 177 Case No.:42/21/82- ALC4/2015 Party Name:NATCO PHARMA LIMITED Meet No/Date:12/82- ALC4/2016 28.09.2016 Status: Deferred HQ File ;01/82/050/01747/AM16/ RLA File :09/24/040/00520/AM16/ Lic.No/Date:0910062967 11.12.2015 Defer Date:29.11.2016 by NO in its meeting No.07/82 dated 4.07.2015, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Voi.1. RA concerned may take necessary action as per decision of NO. 178 Case No.:56/21/82- ALC4/2015 Party Name:ViViMED LABS LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision :Deferred. 179 Case No.:30/19/82- ALC4/2015 Party Name;PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision iDeferred. 180 Case No.:31/19/82- ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/01511/AM16/ RLA File ;05/24/040/00375/AM16/ Lie. No/Date:0510396609 14.12.2015 Defer Date:29.11.2016 Decision :Deferred. 181 Case No.:32/19/82' ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision :Deferred. 182 Case No.:10/19/82- ALC4/2015 Party NameTATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/01490/AM16/ RLA File ;34/24/040/00223/AM16/ Lic.No/Dat0:341OO41732 14.12.2015 Defer Date:29.11.2016 29

Decision :Deferred. 183 Case No.:39/19/82- ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision :Deferred. 184 Case No.:41/19/82- ALC4/2015 Party NameJUBILANT LIFE SCIENCES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/05G/G1522/AM16/ RLA File :05/23/040/00001/AM16/ Lic.No/Date:0510396632 16.12.2015 Defer Date:29.11.2016 Decision iDeferred. 185 Case No.:42/19/82- ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/01523/AM16/ RLA File :05/23/040/00192/AM16/ Lic.No/Date:0510396633 16.12.2015 Defer Date:29.11.2016 Decision iDeferred. Case No.:8/15/82- ALC4/2015 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 186 HQ File ;01/82/050/01319/AM16/ RLA File :09/24/040/00536/AM16/ Lic.No/Date:0910062985 17.12.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/860/2015-PI(Norms) dated 17.10.2016 , uploaded at the end of these minutes or as applied by the firm whichever is 187 Case No.:9/15/82- ALC4/2015 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:12/82- ALC4/2016 28.09.2016 Status: Deferred HQ File :01/82/050/01320/AM16/ RLA File :09/24/040/00530/AM16/ Lic.No/Date:0910062986 17.12.2015 Defer Date:29.11.2016 Decision : Copy of application has been sent to DoP for comments. 188 Case No.:36/19/82- ALC4/2015 Party Name: PANACEA BIOTEC LTD.. Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusrDeferred HQ File :01/82/050/01517/AM16/ RLA File :05/24/040/00439/AM 16/ Llc.No/Date;0510396670 18.12.2015 Defer Date:29.11.2016 Decision : Ijeterreo lor want of comments from DBT. 189 Case No.:35/19/82- ALC4/2015 Party Name:HELLO PAINTS (P) LTD Meet No/Date: 12/82- ALC4/2016 Status:Deferred 30

28.G9.2G16 HQ File :01/82/050/01516/AM16/ RLA File :Q5/23/040/00396/AIVI16/ Lic.No/Date;G510396751 21.12.2G15 Defer Date:29.11.2016 Decision :Deferred. 190 Case No.:33/19/82- ALC4/2015 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/01514/AM16/ RLA File :05/24/04G/0G448/AM16/ Lic.No/Date:0510396777 21.12.2015 Defer Date:29.11.2016 Decision :Deferred. 191 Case No.:54/21/82- ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/01759/AM16/ RLA File :09/24/040/00525/AM16/ Lic.No/Date:0910063015 21.12.2015 Defer Date:29.11.2016 Decision :Deferred. 192 Case No.:61/21/82- ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/05a/01766/AM16/ RLA File :09/24/04G/GG547/AM 16/ Lic.No/Date:0910063018 21.12.2015 Defer Date:29.11.2016 Decision :Deferred. 193 Case No.:93/19/82- ALC4/2015 Party Name:CURETECH SKINCARE Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved HQ File :01/82/050/01574/AM16/ RLA File :22/24/040/00051/AM16/ Lic.No/Date:2210015392 23.12.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/853/2015-PI(Norms) dated 08.09.2016 , uploaded at the end of these minutes or as applied by the firm whichever is NO. Case No.:55/21/82- ALC4/2015 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred 194 HQ File :01/82/050/01760/AM16/ RLA File :09/24/040/00573/AM 16/ Lic.No/Date:0910063035 28.12.2015 Defer Date:29.11.2016 Decision : The representative of D/o Pharmaceuticals has stated that export product pertain to DCPC. 195 Case No.:21/19/82- ALC4/2015 Party Name:HPL ADDITIVES LIMiTED(FORMERLY KNOWN HIGH POLYMER Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved HQ File :01/82/050/01501/AM16/ RLA File :05/23/040/00391/AM16/ Lie. No/Date:0510397095 29.12.2015 Defer Date: 31

Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NO in its meeting No.09/82 dated 20.10.2014, uploaded at the end of these minutes or as applied by the firm whichever Is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NO. 196 Case No.:34/21/82- ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Statu$:Deferred HQ File :01/82/050/01739/AM16/ RLA File :31/83/040/00128/AM16/ Lic.No/Date:3110065816 30.12.2015 Defer Date:29.11.2016 Decision :Ueferred. 197 Case No.:22/19/82- ALC4/2015 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/01502/AM16/ RLA File :05/23/040/00244/AM16/ Lie. No/Date:0510397137 30.12.2015 Defer Date:29.11.2016 ueusion . inrormdtion called for from the firm in NC meeting No.06/82 dated 14.06 2016 is awaited. 198 case No.:23/19/82- ALC4/2015 Party Name:FRESENIUS kabi oncology LIMITED Meet No/Date:12/82- ALC4/2016 28.09.2016 Status:Oeferred HQ File ;01/82/050/01503/AM16/ RLA File :05/23/040/00260/AM16/ Lie. No/Date:0510397138 30.12.2015 Defer Date:29.11.2016 awaiteT * HC meeting No.06/82 dated 14.06.2016 is 199 Case No.:13/19/82- ALC4/2015 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 awaited." " ' 200 Case No.:47/21/82- ALC4/2015 HQ File :01/82/060/01752/AM16/ Party Name:BHAGIRADHA CHEMICALS & industries limited Decision :Deferred. RLA File :09/24/040/00670/AM16/ Meet No/Date: 12/82- ALC4/2016 28.09.2016 Llc.No/Date:0910063087 01.01.2016 StatusiDeferred Defer Date:29.11.2016 Case No.:35/21/82. ALC4/2015 201 HQ File :01/82/050/01740/AM16/ Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Decision iDeferred. RLA File :31/83/040/00094/AM16/ Meet No/Date: 12/82- ALC4/2016 28.09.2016 Lic.No/Date:3110065843 01.01.2016 StatusiDeferred Defer Date:29.11.2016 32

Case No.:33/21/82- ALC4/2015 Party Name:BALAJi AMINES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Approved 202 HQ File :01/82/050/01738/AM16/ RLA File :31/83/040/00117/AM16/ Llc.No/Date:3110065848 05.01.2016 Defer Date: by NO in its meeting No.24/82 dated 15.11.2012, uploaded at the end of these minutes or as necessary action as per decision of NO. 203 Case No.:137/16/82- ALC4/2015 ^arty Name:DEEPAK NITRITE LIMITED

Meet No/Date:12/82- UC4/2016 28.09.2016 Statu$:Approved HQ File :01/82/050/01457/AM16/ RLA File :34/24/040/00245/AM16/ LIc.No/Date:3410041783 D5.01.2016 Defer Date: by NC In its meeting No.08/82 dated 25.09.2014, uploaded at the end of these minutes or as 204 Case No.:2/17/82- ALC4/2015 Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ Fiie ;01/82/050/01462/AM16/ RLA File :09/24/040/00571/AM16/ Lic.No/Date:0910063114 08.01.2016 Defer Date:29.11.2016 Decision : The Committee in light of the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/217/2016-PI{Norms) dated 18.10.2016 decided to cali for complete technical details/information as per Appendix-33 and deferred the case. 205 Case No.:5/17/82- ALC4/2015 Party Name:DYNAMiC SPECIALITY CHEMICALS LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ Fiie :01/82/050/01465/AM16/ RLA File :30/24/040/00035/AM16/ Lic.No/Date:3010103695 11.01.2016 Defer Date:29.11.2016 Decision : Deferred. Case No.:33/2/82- ALC4/2016 Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 206 HQ File :01/82/050/00033/AM17/ RLA File :03/95/040/00737/AM16/ Lic.No/Date:0310801688 11.01.2016 Defer Date: by NC in its meeting No.06/82 dated 08.05.2012, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Voi.1. RA concerned may take 207 Case No.:60/21/82- ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File RLA File Lic.No/Date:0910063135 Defer 33

:01/82/050/01765/AM16/ :09/24/040/00581/AM16/ 13.01.2016 Date:29.11.2016 Decision : Deferred. Case No.:37/2/82- ALC4/2016 Party Name:ALKALOIDS CORPORATION Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusrDeferred 208 HQ File :01/82/050/00037/AM17/ RLA File :02/24/040/00181/AM16/ Lie. No/Date:0210206452 19.01.2016 Defer Date:29.11.2ai6 ! A recommendation of D/o Pharmaceuticals forwarded 21.10.2016 decided to call for COA of the imported details leaves from the foreign supplier and deferred the case 209 Case No.:36/21/82- ALC4/2015 Party Name:AMOL PHARMACEUTICALS PVT LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status; Approved HQ File :01/82/050/01741/AM16/ RLA File :13/24/040/00038/AM16/ Lic.No/Date:1310048100 20.01.2016 Defer Date: to ratify norms on repeat basis based on the recommendation oi D/o Pharmaceuticals forwarded vide O.M. No.35011/47/2016-PlfNorms^ dated 08.09.2016 uploaded at the end of these minutes or as applied by the firm whichever is 210 Case No.:4/21/82- ALC4/2015 Party NameiSHREE BANKEY BEHARI LAL AROMATICS Meet No/Date; 12/82- ALC4/2016 28.09.2016 Status: Approved HQ File ;01/82/050/01709/AM16/ RLA File 05/24/040/00521/AM16/ Lic.No/Date:0510397403 22.01.2016 Defer Date: . I ne uommittee decided to ratify norms based on the earlier decision taken by NO in ts rneeting No.11/82 dated26.11.2014 , uploaded at the end of these minutes or as applied by he f™ whichever is less under para 4.07 of HBP Voi.1. RA concerned may take necessary action as per decision of NO. ^ 211 Case No.:31/21/82- ALC4/2015 Party Name:BALAJI AMINES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/01736/AM16/ RLA File :31/83/040/00148/AM16/ Lic.No/Date:3110065887 25.01.2016 Defer Date:29.11.2016 uecision : Deterred. 212 Case No.:24/21/82- ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/01729/AM16/ RLA File :34/24/040/00267/AM16/ Lie. No/Date:3410041832 28.01.2016 befer Date:29.11.2016 ijfiri.Qinn I neferrori 213 Case ALC4/2016 No.:88/4/82- Name:VAYA JAYANTHI DRUGS(P) LTD.. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status; Approved 34

HQ File :01/82/050/00151/AM17/ RLA File :09/24/040/00630/AM16/ Llc.No/Date:0910063185 29.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/848/2015-PI(Norms) dated 13.10.2016, 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 NO. 214 Case No.:17/10/82- ALC4/2016 Party Name:IND-SWIFT LABORATORIES LTD.. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00363/AM17/ RLA File :22/24/040/00104/AM16/ Llc.No/Date:2210015407 01.02.2016 Defer Date:29.11.2016 215 Case No.:8/21/82- ALC4/2ai5 Party Name:JUBILANT GENERICS LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/01713/AM16/ RLA File :05/23/040/00438/AM16/ Llc.No/Date:0510397455 01.02.2016 Defer Date:29.11.2016 Decision: Deferred. 216 Case No.:13/21/82- ALC4/2015 Party Name:JLIBILANT LIFE SCIENCES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision : Deferred. 217 Case No.:1/19/82- ALC4/2015 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File ;01/82/050/01481/AM16/ RLA File :09/24/040/00634/AM16/ Lic.No/Date:0910063213 04.02.2016 Defer Date:29.11.2016 Decision :Deferred. 218 Case No.:4/19/82- ALC4/2015 Party Name:ALPHAMED FORMULATIONS P LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/01484/AM16/ RLA File :09/24/040/00628/AM16/ Llc.No/Date:0910063226 05.02.2016 Defer Date:29.11.2016 Decision ; Information called for from the firm In NO meeting No.08/82 dated 27.07.2016 Is 219 Case No.:25/21/82- ALC4/2015 Party Name:RONAK CHEMICALS Meet No/Date; 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/01730/AM16/ RLA File :34/24/040/00274/AM16/ Llc.No/Date:3410041858 05.02.2016 Defer Date:29.11.2016 Decision :Deferred for want of comments from DoP. 35

220 Case No.:26/21/82- ALC4/2015 Party Name:RONAK CHEMICALS Meet No/Date: 12/82- ALC4/2016 28.G9.2G16 Status:Deferred HQ File :01/82/050/G1731/AM16/ RLA File :34/24/G4G/GG273/AM16/ Lic.No/Date:3410G41857 G5.02.2G16 Defer Date:29.11.2016 221 Case No.:14/21/82- ALC4/2015 Party Name:DHAMPUR SUGAR MILLS LTD Meet No/Date:12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :Q1/82/050/01719/AM16/ RLA File :05/23/G4G/GG456/AM16/ Lic.No/Date:G510397521 08.02.2016 Defer Date:29.11.2016 Decision iDeferred. 222 Case No.:5/19/82- ALC4/2015 Party Name;GOPINATH CHEM-TECH LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/01485/AM16/ RLA File :08/24/04G/G0291/AM16/ Lic.No/Date:0810137155 08.02.2016 Defer Date:29.11.2016 Decision ; Deferred. 223 Case No.:62f4/82- ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File ;01/82/05G/G0125/AM17/ RLA File :G3/95/040/0G568/AM16/ Lie. No/Date:0310802284 08.02.2016 Defer Date:29.11.2016 uectsion: Deferred. 224 Case No.:85/19/82- ALC4/2015 Party Name;ANUPAM RASAYAN {INDIA) LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File 01/82/G5G/G1566/AM16/ RLA File 52/24/G4G/GGG76/AM16/ Lic.No/Date:5210041759 09.02.2016 Oefer Date:29.11.2016 Decision : Deterred tor want of comments from DoP. 225 Case No.:95/19/82- ALC4/2015 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved HQ File :01/82/050/01576/AM16/ RLA File :09/24/040/00639/AM16/ Lic.No/Date:0910063233 10.02.2016 Defer Date: 'r 0" recommendation of D/o '^O-35011/173/2016-PI(Norms) dated Sept. 2016 nf HRP /nlV pf whictiever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC 226 Case No.:8/2/82- ALC4/2016 Party Name.GULBRANDSEN CHEMICALS PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00008/AM17/ RLA File :34/24/040/00284/AM16/ Lic.No/Date;3410041870 10.02.2016 Defer Date:29.11.2016 36

Decision :Deferred. 227 Case No.:15/10/82- ALC4/2016 Party Name:INFINlTY LABORATORIES PVT.LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision : Deferred for want of comments from DoP. 228 Case No.:30/21/82- ALC4/2015 Party NameJODAS EXPOIM PVT.LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/01735/AM16/ RLA File :05/23/040/00467/AM16/ Lic.No/Date:0510397580 10.02.2016 Defer Date:29.11.2016 229 Case No.:97/19/82- ALC4/2015 Party Name:AUROBlNDO PHARMA LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/01578/AM16/ RLA File ;09/24/040/00652/AM16/ Lic.No/Date:0910063248 11.02.2016 Defer Date:29.11.2016 Decision : Copy of application may be sent to DoP. 230 Case No.:36/2/82- ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00036/AM17/ RLA File ;03/95/040/00870/AM16/ Lic.No/Date:0310802475 11.02.2016 Defer Date:29.11.2016 Decision :Deferred. 231 Case No.:35/4/82- ALC4/2016 Party Name;!NDOCO REMEDIES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00098/AM17/ RLA File :03/94/040/00952/AM16/ Lic.No/Date:0310802542 12.02.2016 Defer Date:29.11.2016 232 Case No.:101/19/82- ALC4/2015 Party Name:AUROBINDO PHARMA LIMITED Meet N o/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/060/01582/AM16/ RLA File :09/24/040/00668/AM16/ Lic.No/Date:0910063275 16.02.2016 Defer Date:29.11.2016 Decision : copy of application may be sent to DoP. 233 Case No.:5/2/82- ALC4/2016 Party Name.MAMTA POLYCOATS Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision :Deferred. 37

234 Case No.:13/10/82- ALC4/2016 Party Name;IND-SWlFT LABORATORIES LTD.. Meet No/Date;12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00359/AM17/ RLA File :22/24/040/00109/AM16/ Lic.No/Date:2210015417 17.02.2016 Defer Date:29.11.2016 235 Case No.:55/2/82- ALC4/2016 Party Name:MAHARSHI PHARMA CHEM PVT. LTD. Meet N o/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision : Information called for from the firm in NC meeting No.08/82 dated 27.07.2016 is 236 Case No.:35f2/82- ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusrDeferred HQ File :01/82/050/OG035/AM17/ RLA File :03/95/040/00868/AM16/ Llc.No/Date:0310802660 17.02.2016 Defer Date:29.11.2016 Decision :Deferred. 237 Case No.:102/19/82- ALC4/2015 Party Name:V!VIMED LABS LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File 01/82/Q50/01583/A[yi16/ RLA File 09/24/040/00666/AM16/ Lie. No/Date:0910063280 17.02.2016 Defer Date:29.11.2016 Decision lUeterred. Case No.:52/2/82- ALC4/2016 Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 238 HQ File :01/82/050/00052/AM17/ RLA File :05/23/040/00426/AM16/ Lic.No/Date:0510397651 18.02.2016 Defer Date: uecision . 1 ne Committee decided to ratify norms on repeat basis based on the earlier decision « K '"'ts-meeting No.4/82 dated 12.06.2015, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Voi.1. RA ooncerned may take 239 Case No.:20/4/82- ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00083/AM17/ RLA File :05/23/040/00469/AM16/ Lic.No/Date:0510397644 18.02.2016 Defer Date:29.11.2016 uecisron rUeterred. — 240 uase No.:23/4/82- ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred 38

HQ File :01/82/050/00086/AM17/ RLA File :05/23/040/00470/AM16/ Lic.No/Date;0510397643 18.02.2016 Defer Date:29.11.2016 Decision :Deferred. 241 Case No.:34/2/82- ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision :Deferred. 242 Case No.:9/2/82- ALC4/2016 Party Name:DEEPAK NITRITE LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00009/AM17/ RLA File :34/24/040/00161/AM16/ Lic.No/Date:3410041915 22.02.2016 Defer Date:29.11.2016 by NO in its meeting No.44/82 dated 31.01.2012, uploaded at the end of these minutes or as necessary action as per decision of NO. 243 Case No.:27/2/82- ALC4/2016 Party Name:PRIVI ORGANICS LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00027/AM17/ RLA File :03/95/040/00874/AM16/ Lic.No/Date:0310802827 24.02.2016 Defer Date:29.11.2016 Decision :Deferred. 244 Case No.:22/2/82- ALC4/2016 Party Name:SANJIVANI PARANTERAL LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00022/AM17/ RLA File ;03/95/040/00897/AM 16/ Lic.No/Date:0310802826 24.02.2016 Defer Date:29.11.2016 Decision ;Deferred for want of comments from DoP. 245 Case No.:18/4/82- ALC4/2018 Party Name:VDH CHEM TECH PVT. LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00081/AM17/ RLA File ;05/24/040/00550/AM16/ Lic.No/Date:0510397711 24.02.2016 Defer Date:29.11.2016 Decision :Deferred. 246 Case No.:24/4/82- ALC4/2016 Party Name; JUBILANT LIFE SCIENCES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00087/AI/l17/ RLA File :05/23/040/00491/AM16/ Lic.No/Date:0510397731 26.02.2016 Defer Date:29.11.2016 Decision iDeferred. 247 Case No.:4/2/82- Party Name:RIDDHI Meet No/Date: 12/82- StatusiDeferred 39

ALC4/2016 PHARMA ALC4/2016 28.09.2016 HQ File :01/82/050/00004/AM17/ RLA File ;34/24/040/00301/AM16/ Lic.No/Date:3410041924 26.02.2016 Defer Date:29.11.2016 Decision: Deferred. 248 Case No.:84/4/82- ALC4/2016 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00147/AM17/ RLA File ;09/24/040/00648/AM16/ Lic.No/Date:0910063326 26.02.2016 Defer Date:29.11.2016 Oectsion :Deferred. 249 Case No.:43/2/82- ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00043/AM17/ RLA File :03/95/040/00948/AM16/ Lic.No/Date:0310802906 29.02.2016 Defer Date:29.11.2016 uecision :Deterred. 250 Case No.:6/2/82- ALC4/2016 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00006/AM17/ RLA File :34/24/040/00308/AM16/ Lic.No/Date:3410041932 01.03.2016 Defer Date:29.11.2016 uecision :Ueterred. 251 Case No.;42/2/82- ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 uecision :Deferred. 25? - Case No.: 14/2/82- 'VLC4/2016 Party Name:SHIVA PHARMACHEM LTD. Meet No/Date: 12/82- '\LC4/2016 28.09.2016 Status:Deferred HQ File 01/82/050/00014/AM17/ ^LA File 34/24/040/00221/AM16/ ( Jc.No/Date:3410041935 51.03.2016 Defer Date:29.11.2016 |iJecision :Ueterrecl. — 253 Case No.:38/2/82- ALC4/2016 Party Name:WANBURY LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Approved HQ File :01/82/050/00038/AM17/ RLA File :03/95/040/00920/AM16/ Lie. No/Date:0310802986 02.03.2016 Defer Date: ine committee decided to ratify norms on repeat basis based pariipr recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/705/2013-PI(Norms) 40

of NC. 254 Case No.:28/4/82- ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00091/AM17/ RLA File :03/94/04p/00959/AM16/ Lic.No/Date:0310803032 03.03.2016 Defer Date:29.11.2016 Decision :Deferred. 255 Case No.:29/4/82- ALC4/2016 Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00092/AM17/ RLA File :03/94/040/01004/AM16/ Lic.No/Date:0310803038 03.03.2016 Defer Date:29.11.2016 Decision: Deferred. 256 Case No.:3/4/82- ALC4/2016 Party Name:JAGSONPAL PHARMACEUTICALS LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00066/AM17/ RLA File :05/23/040/00502/AM16/ Lic.No/Date:0510397820 04.03.2016 Defer Date:29.11.2016 Decision : Information called for from the firm in NC meeting No.10/82 dated 23.08.2016 is 257 Case No.:50/2/82- ALC4/2016 Party Name:PANERA BIOTEC PVT.LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision : Deferred for want of comments from DBT. 258 Case No.:66/4/82- ALC4/2016 Party Name;STRIDES SHASUN LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00129/AM17/ RLA File ;04/24/040/00257/AM16/ Lic.No/Date:0410161685 04.03.2016 Defer Date:29.11.2016 Decision : The Committee as per recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/154/2016-PI(Norms) dated 05.09.2016, decided to call for copy of Master Batch Formula duly authenticated by their Q.C. incharge from the firm and deferred the case. 259 Case No.:67/4/82- ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision : The Committee as per recommendation of D/o Pharmaceuticals fonwarded vide O.M.No.35011/154/2016-PI(Norms) dated 05.09.2016, decided to call for copy of Master Batch Formula duly authenticated by their Q.C. incharge from the firm and deferred the case. 41

Case INo.:68/4/82- ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 260 HQ File ;01/82/050/00131/AM17/ RLA File :04/24/040/00255/AM16/ Lic.No/Date:0410161683 04.03.2016 Defer Date: Decision . ine committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/102/2016-PI(Norms) dated August 2016 mpulak f jh® Pi' whichever is less. RA concerned may take further necessary action as per the decision of NC. Case No.:41/4/82- ALC4/2016 262 HQ File :01/82/060/00104/AM17/ Party Name:BTL EXPORTS PVT. LTD.. RLA File : 03/94/040/01018/AM16/ Meet No/Date:12/82- ALC4/2016 28.09.2016 StatusiDeferred Lie. No/Date:0310803103 07.03.2016 Defer Date:29.11.2016 1. drug manufacturing license for the export product with approved Copy of valid composition. The Committee accordingly deferred the case. 2. 3. 4. 5. 263 Case ALC4/2016 No.;57/4/82- HQ . File :01/82/050/00120/AM17/ Party Name:CLARIANT INDIA LIMITED Decision :Deferred. RLA File :03/94/040/01041/AM 16/ Meet No/Date: 12/82- ALC4/2016 28.09.2016 Lic.No/Date:0310803137 08.03.2016 Status:Deferred Defer Date:29.11.2016 264 Case ALC4/2016 No.;7/2/82- Party Name:SONGWON SPECIALTY CHEMICALS INDIA PVT LTD. HQ File :01/82/050/00007/AM17/ Decision :Deferred. HIA File :34/24/040/00323/AM16/ Meet No/Date: 12/82- ALC4/2016 28.09.2016 Llc.No/Date:3410041954 08.03.2016 StatusiDeferred Defer Date:29.11.2016 261 Case No.:40/4/82- ALC4/2016 Party Name:BTL EXPORTS PVT. LTD.. Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00103/AM17/ RLA File :03/94/040/01017/AM16/ Lie. No/Date:0310803105 07.03.2016 Defer Date:29.11.2016 uecisioii :Deferred. — 42

Case No.:56/4/82- ALC4/2016 ^'arty Name:CLARIANT NDIA LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred 265 HQ File 01/82/050/00119/AM17/ RLA File 03/94/040/01040/AM16/ Lic.No/Date;0310803170 09.03.2016 Defer Date:29.11.2016 Decision iDeferred. 266 Case No.:55/4/82- ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00118/AM17/ RLA File :03/94/040/01044/AM16/ Llc.No/Date:0310803171 09.03.2016 Defer Date:29.11.2016 Case No.:30/2/82- ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred 26/ HQ File :01/82/050/00030/AM17/ RLA File :03/95/040/00940/AM16/ Lic.No/Date:0310803176 09.03.2016 Defer Date:29.11.2016 Decision iDeferred. Case No.:31/2/82- ALC4/2016 Party Name: NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred 268 HQ File :01/82/050/00031/AM17/ RLA File :03/95/040/00931/AM16/ Lic.No/Date:0310803177 09.03.2016 Defer Date:29.11.2016 Decision iDeferred. Case No.:3/2/82- ALC4/2016 Party Name:RONAK CHEMICALS Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred 269 HQ File :01/82/050/00003/AM17/ RLA File ;34/24/040/00329/AM16/ Lic.No/Date:3410041957 09.03.2016 Defer Date:29.11.2016 Decision ' npfftrreri fnr want of comments from DoP. Case ALC4/2016 270 No.:29/2/82- HQ File ;01/82/050/00029/AM17/ Party Name:RUSAN PHARMA LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Lic.No/Date:0310803186 09.03.2016 Status: Approved Defer Date: RLA File :03/95/040/00924/AM16/ Dpcision - The Committee decided to ratify norms on repeat basis based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/87/2016-PI(Norms) dated 08 09 2016 uploaded at the end of these minutes or as applied by the firm whichever is tess under para Ii7 of HBP Vol.1. RA concerned may take necessary action as per decision of NO. 271 Case No.;16/10/82- ALC4/2016 Party Name:SALIRAV CHEMICALS LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved HQ File RLA File Lic.No/Date:2210015442 Defer 43

:01 /82/050/003(32/AM 11t [:22/24/Q40/00122/AM1^ |09.03.2016 ' Date; ss sir 272 Case No.:39/4/82- ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date; 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00102/AM17/ Decision : Deferred for wa RLA File :03/94/040/00973/AM16/ Lie. No/Date:0310803223 10.03.2016 Defer Date:29.11.2016 Case ALC4/2016 273 No.:58/2/82- Party Name:CHlROS PHARMA File RLA fiIp ^01/82/05Q/00058/AM17/ 22/24/040/00115/AM16/ Ipeciston : Deferred for want of comments from DoP. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Lie. No/Date:22 Too15444 11.03.2016 Status:Deferred Defer Date:29.11.2016 Case ALC4/2016 274 No.:59/2/82- HQ File :01/82/050/00059/AM17/ Party NameiCHlROS PHARMA Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred RLA File ;22/24/040/00112/AM16/ ^cision : Deferred for want of comments from DopT Lie. No/Date:2210015443 11.03.2016 Defer Date:29.11.2016 Case ALC4/2016 No.:38/4/82- IParty Name:AIMS IMPEX PVT. LTD., HQ Fite 275 |:01/82/050/00101/AM17/ File ■03/94/040/01049/AM16/ Meet No/Date; 12/82- ALC4/2016 28.09.2016 Lie.No/Date:0310803267 14.03.2016 Status: approved Defer Date: r- ^ w.w/, ,u/ l*t.UO.ZUlD Datp- as applied by the firm whichever is less under pafa 1 necessary action as per decision of NC -U/of HBP Vol.1. RA concerned may take 276 Case No.;176/10/82- ALC4/2016 Party Name:DEEPAK (mS NOVOCHEM TECHNOLOGIES LTD fi'e RLA fu^ ■01/82/050/00522/AM17/ ;31/83/040/00178/AM1fi/ Decision :Deferred. — No/Date: 12/82- ALC4/2016 28.09.2016 Lic.No/Date:311006604^ 14.03.2016 Status:Deferred Defer Date:29.11.2016 277 Case No.:27/4/82- ALC4/2016 Party Name:ETERNIS p'ne chemicals LIMITED HQ File RLA ^ ^—'— ^01/82/050/00090/am17/ :03/94/04n/nnfl«i/AM!l'f 28.09.2016 Lic.No/Date:0310803290 14.03.2016 Defer Date: —— It.uo.ZU 10 44

taken by NC in its meeting No.04/82 dated 16.05.2013, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take 278 Case No.:13/1/82- ALC1/2016 Party Name:ONEIRO CHEMICALS LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/01787/AM16/ RLA File :34/24/040/00286/AM16/ Lic.No/Date:3410041972 14.03.2016 Defer Date:29.11.2016 Decision :Deferred. 279 Case No.:37/4/82- ALC4/2016 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision : Deferred. Case No.:143/10/82- ALC4/2016 Party NameiMYLAN LABORATORIES LIMITED Meet N o/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 280 HQ File :01/82/050/00489/AM17/ RLA File :09/24/040/00726/AM16/ Lic.No/Date:0910063418 15.03.2016 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/05/2016-PI(Norms) dated 06.06.2016 , uploaded at the end of these minutes or as applied by the firm whichever is NC. 281 Case No.:144/10/82- ALC4/2016 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00490/AM17/ RLA File ;09/24/040/00727/AM 16/ Lic.No/Date:0910063417 15.03.2016 Defer Date:29.11.2016 282 Case No.:26/4/82- ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00089/AM17/ RLA File :03/94/040/01057/AM16/ Lic.No/Date:0310803376 16.03.2016 Defer Date:29.11.2016 Decision iDeferred. 283 Case No.:168/10/82- ALC4/2016 Party Name;RA CHEM PHARMA LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00514/AM17/ RLA File :09/24/040/00741/AM16/ Lic.No/Date:0910063422 16.03.2016 Defer Date:29.11.2016 45

284 Case No.:7/4/82- ALC4/2016 Party NameiJUBILANT LIFE SCIENCES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/05G/0007a/AM17/ RLA File :05/23/040/00468/AM16/ Lic.No/Date:0510397952 17.03.2016 Defer Date:29.11.2016 uecision :Deferi'ed. 285 Case No.:13/4/82- ALC4/2016 Party Name;JUBiLANT LIFE SCIENCES LIMiTED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00076/AM17/ RLA Fiie :05/23/040/00390/AM16/ Lic.No/Date:0510397953 17.03.2016 Defer Date:29.11.2016 uecision :ueterred. 286 Case No.:145/10/82- ALC4/2016 Party Name:MSN PHARMACHEM PRIVATE LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File ;01/82/050/00491/AM17/ RLA File :09/24/040/00725/AM16/ Lic.No/Date:0910063424 17.03.2016 Defer Date:29.11.2016 Uecision . Uererred tor want of comments from DoP. 287 r case No.:5/4/82- ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD.. Meet No/Date:12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File 01/82/050/00068/AM17/ RLA File 05/23/040/00544/AM16/ Lie. No/Date:0510397982 18.03.2016 Defer Date:29.11.2016 Decision . Deterred tor want of comments from DoP. 288 Case No.::8/4/82- ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ Fiie :01/82/050/00071/AM17/ RLA File :05/23/040/00541/AM16/ Uc.No/Date:0510397985 18.03.2016 Defer Date:29.11.2016 uecisiuii. Deleired tor want of comments from DoP. 289 Case No.:153/10/82- ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00499/AM17/ RLA File :09/24/040/00738/AM16/ Lic.No/Date:0910063433 18.03.2016 Defer Date:29.11.2016 utLision . Ucieiied loi want ot comments from DoP 290 Case No.:8ii/4/82- ALC4/2016 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusrOeferred HQ File :01/82/060/00148/A(VI17/ Decision :Deferred. ^LA File :09/24/040/00742/AM16/ Lic.No/Date:0910063432 18.03.2016 Defer Date:29.11.2016 |2^|Case No.:36M/82- Name:INDOFIL|Meet No/Dite:12/82^~[status:Deferred 46

ALC4/2016 INDUSTRIES LTD. ALC4/2016 28.09.2016 HQ File :01/82/050/00099/AM17/ RLA File :03/94/040/01056/AIVl16/ Lic.No/Date;0310803468 21.03.2016 Defer Date:29.11.2016 Decision : Deferred. 292 Case No.:4/4/82- ALC4/2016 Party Name.JODAS EXPOIM PVT.LTD., Meet No/Date; 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00067/AM17/ RLA File :05/23/040/00543/AM16/ Lic.No/Date:0510397989 21.03.2016 Defer Date:29.11.2016 293 Case No.:6/4/82- ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00069/AM17/ RLA File :05/23/040/00542/Ai/l16/ Llc.No/Date:0510397988 21.03.2016 Defer Date:29.11.2016 294 Case No.:81/4/82- ALC4/2016 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet N o/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File ;01/82/050/00144/AM17/ RLA File :03/95/040/00984/AM16/ Llc.No/Date:0310803500 22.03.2018 Defer Date:29.11.2016 Decision ;Deferred. Case No.:49/4/82- ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 295 HQ File -.01/82/050/00112/AM17/ RLA File :03/94/040/01046/AM16/ Llc.No/Date:0310803524 23.03.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.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 Case No.:50/4/82- ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Deferred 296 HQ File :01/82/050/00113/AM17/ RLA File :03/94/040/01070/AM16/ Lic.No/Date:0310803526 23.03.2016 Defer Date:29.11.2016 Decision iDeferred. 297 Case No.:108/7/82- ALC4/2016 Party Name:FRESENIUS KABl ONCOLOGY LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved HQ File ;01/82/050/00282/AM17/ RLA File :05/23/040/00518/AM16/ Lic.No/Date:0510398017 23.03.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on tne 47

recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35^1/186/2016-PKNornTS^ dated 10.08.2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Voi.l RA concerned may take necessary action as per decision of Case No.:142/10/82- ALC4/2016 Party Name:RA CHEM PHARMA LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 298 HQ File :01/82/060/00488/AM17/ RLA File :09/24/040/00756/AM16/ Lie. No/Date:0910063439 23.03.2016 Defer Date: uBuibiuii 1 ne committee decided to ratify norms on repeat basis based earlier decision taken aLnpH'h No^10/82 dated 22.08.2013. uploaded at the end of thes^m™ applied by the firm whichever is less under para 4.07 of HBP Vol 1 RA concerned mav take concernea may take Case ALC4/2016 No.:63/4/82- 299 HQ File :01/82/050/00126/AM17/ Party Name:BEN20 CHEM INDUSTRIES PRIVATE LIMITED, RLA File :03/94/040/01037/AM16/ Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved Lic.No/Date:0310803569 28.03.2016 Defer Date: p. . . — —^ .W L^dic. 300 [Case ALC4/2016 No.:47/4/82- HQ File :01/82/050/00110/AM17/ Party Name:HUBERGROUP INDIA PRIVATE LIMITED. RLA File :03/94/040/01078/AM16/ Decision rDeferred. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred Lrc.No/Date:0310803568 28.03.2016 Defer Date:29.11.2016 Case No.:60/2/82- ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date; 12/82- ALC4/2016 28.09.2016 Status:Approved 301 HQ File :01/82/050/01863/AM16/ RLA File :09/24/040/00710/AM16/ Lic.No/Date:0910063454 29.03.2016 Defer Date: ej under para 4.07 of HBP Voi.1. RA concerned mayTak" nlce's'sa^^'c'tion^Wed^ Case ALC4/2016 No.:46/4/82- [Party Name:AVIGNON EXIM PVT.LTD.. 302 HQ File :01/82/050/00109/AM17/ eet No/Date: 12/82- ALC4/2016 28.09.2016 RLA File 03/94/040/01109/AM16/ Status: Approved Lie. No/Date:0310803597 29.03.2016 Defer Date: T": — ID nfltp- 48

Case No.:173/10/82- ALC4/2016 Party Name:CURETECH SKINCARE Meet No/Date; 12/82- ALC4/2016 28.09.2016 Status: Approved 303 HQ File :01/82/050/00519/AM17/ RLA File :22/24/040/00108/AM16/ Lic.No/Date;2210015458 29.03.2016 Defer Date; recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/853/2015-PI{Norms) dated 08.09.2016 , uploaded at the end of these minutes or as applied by the firm whichever is NC. 304 Case No.:80/4/82- ALC4/2016 Party NameiYASHO INDUSTRIES PVT.LTD. Meet No/Date:12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00143/AI/l17/ RLA File :03/95/040/01007/AM16/ Lic.No/Date:0310803591 29.03.2016 Defer Date:29.11.2016 Decision :Deferred. Case No.:165/10/82- ALC4/2016 Party Name:METROCHEM API PVT. LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 305 HQ File :01/82/050/00511/AM17/ RLA File :09/24/040/00751/AM16/ Lie. No/Date:0910063467 30.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/210/2016-PI(Norms) dated Sept. 2016, of HBP Vol. 1. RA concerned may take necessary action as per decision of NC. 306 Case No.:186/10/82- ALC4/2016 Party Name:VOVANTiS LABORATORIES PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 307 Case No.:43/4/82- ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 308 Case No.:69/4/82- ALC4/2016 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision ilnformation has been called for from the in NC meeting No.10/82 dated 23.08.2016 is 49

awaited. 309 Case No.: 76/4/82- ALC4/2016 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00139/AM17/ RLA File ;03/95/040/01015/AM16/ Lic.No/Date:0310803674 31.03.2016 Defer Date:29.11.2016 Decision :Deferred. 310 Case No.:3/10/82- ALC4/2016 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00354/AM17/ RLA File :03/94/040/00645/AM16/ Lic.No/Date:0310803722 01.04.2016 Defer Date:29.11.2016 Decision :Deferred. Case No.:65/4/82- ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:12/82- ALC4/2016 28.09.2016 StatusiApproved 311 HQ File :01/82/050/00128/AM17/ RLA File :04/24/040/00283/AM16/ Lic.No/Date:0410161772 01.04.2016 Defer Date: Decision : The Committee decided to ratify norms on based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/103/2016-(PI-Norms) dated August 2016, of HBP Vol.1. RA concerned may take necessary action as per decision of NC. Case No.:7/10/82- ALC4/2016 Party Name:FERMENTA BIOTECH LTD Meet No/Date: 12/82- ALC4/2016 Status:Deferred 312 28.09.2016 HQ File :01/82/050/00353/AM17/ RLA File :03/94/040/01125/AM16/ Llc.No/Date:0310803764 04.04.2016 Defer Date:29.11.2016 Decision . Information called for from the firm in NC meeting No.06/82 dated 14.05.2016 is 313 Case No.:77/4/82- ALC4/2016 Party Name:TITAN LABORATORIES PVT LTD. Meet No/Date:12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File 01/82/050/00140/AM17/ RLA File : 03/95/040/00001 /AM 17/ Lic.No/Date:0310803752 04.04.2016 Defer Date:29.11.2016 314 Case No.:92/4/82- ALC4/2016 Party Name;SWATI MENTHOL & ALLIED CHEMICALS LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00155/AM17/ RLA File :29/24/040/00010/AM16/ Lic.No/Date:2910025244 06.04.2016 Defer Date:29.11.2016 Decision lUeterredi. |3i5|Dase No.:74/4/82- Party Name:YASHO Meet No/Date: 12/82- IStatusiDeferred 50

ALC4/2016 INDUSTRIES PVT.LTD. ALC4/2016 28.09.2016 HQ File :01/82/050/00137/AM17/ RLA File ;03/95/040/00021/AM17/ Lic.No/Date:G310803871 11.04.2016 Defer Date;29.11.2016 Decision iDeferred. 316 Case No.:66/2/82- ALC4/2016 Party Name:ENCEE AROMATICS PVT. LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00060/AM17/ RLA File :32/24/040/00043/AM16/ Lic.No/Date:3210077862 13.04.2016 Defer Date:29.11.2016 Decision :Deferred for want of comments from DoP. Case No.:5/10/82- ALC4/2016 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:12/82- ALC4/2016 28.09.2016 Status: Approved 317 HQ File :01/82/050/00351/AM17/ RLA File :03/94/040/00024/AM17/ Lic.No/Date:0310803926 13.04.2016 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/213/2016-PI(Norms) dated 18.10.2016 , uploaded at the end of these minutes or as applied by the firm whichever is NO. 318 Case No.:167/10/82- ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00513/AM17/ RLA File :09/24/040/00777/AM16/ Lic.No/Date:0910063505 15.04.2016 Defer Date:29.11.2016 Case No.:141/10/82- ALC4/2016 Party Name:VIRUPAKSHA ORGANICS LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 319 HQ File :01/82/050/00487/AM17/ RLA File :09/24/040/00003/AM17/ Lic.No/Date:0910063503 15.04.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/214/2016-PI{Norms) dated 30.09.2016, of HBP Vol.1. RA concerned may take necessary action as per decision of NC. Case No.:181/10/82- ALC4/2016 Party Name:SATYADEVA PHARMACEUTICALS PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 320 HQ File :01/82/050/00507/AM17/ RLA File :09/24/040/00009/AM17/ Lie. No/Date:0910063508 18.04.2016 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/42/2016-PI(Norms) , of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 51

321 Case No.:127/10/82- ALC4/2016 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date;12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00473/AM17/ RLA File :09/24/040/00008/AM17/ Lic.No/Date:0910063506 18.04.2016 Defer Date:29.11.2016 322 Case No.:166/10/82- ALC4/2016 Party NameiAKTINOS PHARMA PVT LTD, Meet No/Date:12/82- ALC4/2016 28.09.2016 Status; Approved HQ File :01/82/050/00512/AM17/ RLA File :09/24/040/00775/AM16/ Lic.No/Date:0910063518 19.04.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/43/2015"PI{Norms) dated June 105, 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. 323 Case No.:67/2/82- ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved HQ File :01/82/050/00061/AM17/ RLA File :09/24/040/00014/AM17/ Lic.No/Date:0910063515 19.04.2016 Defer Date: uecrsion . Ihe Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/211/2016-PI(Norms) dated Sept 2016 f minutes or as applied by the firm whichever is less under para 4.07 of HBP Voi.1. RA concerned may take necessary action as per decision of NC 324 Case N<).:68/2/82- ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date:12/82- ALC4/2016 28.09.2016 Status: Approved HQ File 01/82/05G/00062/AM17/ RLA File 09/24/040/00G19/AM17/ Lic.No/Date:0910063520 19.04.2016 Defer Date: Decision . me oommittee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/211/2016-PI(Norms) dated Sept 2016 uDn w Py the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC 325 Case No.:3/10/82- ALC4/2016 Party Name:INDOCO REMEDIES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00349/AM17/ RLA File :03/94/040/00042/AM17/ Lic.No/Date:0310804024 20.04.2016 Defer Date;29.11.2016 Decision : Uererreo ror want of comments from DoP. 326 Case No.:69/2/82- ALC4/2016 Party Name:ALMELO PRIVATE LIMITED Meet No/Date:12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00063/AM17/ RLA File 09/24/040/00739/AM16/ Lic.No/Date:0910063533 21.04.2016 Defer Date:29.11.2016 uucisiuii. UeleiieU lui want of comments from DoP. 52

327 Case No.:98/10/82- ALC4/2016 Party Name: ESTEEM INDUSTRIES PVT. LTD, Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Deferred HQ File :01/82/050/00444/AM17/ RLA File :17/24/040/00006/AM17/ Lic.No/Date:1710006305 21.04.2016 Defer Date:29.11.2016 Decision ; Deferred. Case No.:172/10/82- ALC4/2016 Party Name:SHREE BANKEY BEHAR! LAL AROMATICS Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Approved 328 HQ File :01/82/050/00518/AM17/ RLA File :05/24/040/00628/AM16/ Lic.No/Date:0510398255 21.04.2016 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by NO in its meeting No.11/82 dated26.11.2014 , 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 necessary action as per decision of NO. 329 Case No.:99/10/82- ALC4/2016 Party Name:ESTEEM INDUSTRIES PVT. LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00445/AM17/ RLA File :17/24/040/00005/AM17/ Lic.No/Date:1710006311 22.04.2016 Defer Date:29.11.2016 Decision :Deferred. 330 Case No.:164/10/82- ALC4/2016 Party Name:GLAND PHARMA LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Case No.:31/7/82- ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 331 HQ File :01/82/050/00205/AM17/ RLA File :05/24/040/00030/AM17/ Lic.No/Date:0510398296 25.04.2016 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/201/2016-PI(Norms) dated 10.08.2016 , uploaded at the end of these minutes or as applied by the firm whichever is NC. 332 Case No.:125/10/82- ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet N o/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00471/AM17/ RLA File :09/24/040/00033/AM17/ Lie. No/Date:0910063570 29.04,2016 Defer Date:29.11.2016 333 Case No.:118/10/82- Party Name:AUROBINDO Meet No/Date: 12/82- ALC4/2016 PHARMA LIMITED ALC4/2016 Status: Approved 53

28.09.2016 HQ File :01/82/050/00464/AM17/ RLA File :09/24/040/00001/AM17/ Lic.No/Date;0910063572 03.05.2016 Defer Date; Pharmaceuticals forwarded vide O.M.No.35011/260/2016-PI{Norms) dated Septerber 2016, of HBP Vol.1. RA concerned may take necessary action as per decision of NO. 334 Case No.;7/6/82- ALC4/2016 Party NameiMANGALAM ORGANICS LIMITED (FORMERLY DUJODWALA Meet No/Date:12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File ;01/82/050/00174/AM17/ RLA File :03/95/040/00013/AM17/ Lie. No/Date:0310804365 03.05.2016 Defer Date:29.11.2016 uecision : Deferred for want of comments from DoP. 335 Case No.:107/10/82- ALC4/2016 Party Name:BALAJi AMINES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File ;01/82/050/00453/AM17/ RLA File :31/83/040/00001/AM17/ Lie. No/Date:3110066134 04.05.2016 Defer Date:29.11.2016 Decision . 1 ne Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.10/82 dated 22.08.2013. uploaded at the end of these minutes or as applied by the Rrm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take 336 Case No.;108/10/82- ALC4/2016 Party Name:BALAJi AMINES LIMITED Meet No/Date; 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00454/AM17/ RLA File ■31/83/040/00182/AM16/ Lic.No/Date;3110066133 04.05.2016 Defer Date:29.11.2016 Decision :Deferred. 337 case No.:174/10/82- ALC4/2016 Party Name:FRESENiUS KABI ONCOLOGY LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File 01/82/Q50/00520/AM17/ ^LA File 05/23/040/00038/AM17/ Lic.No/Date:0510398377 D4.05.2016 ;)efer Date:29.11.2016 1Jecisioii : Deferred for want of comments from DoP. 338 Case No.:175/10/82- ALC4/2018 Party Name:KLJ PLASTICiZERS LIMITED Meet No/Date:12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00521/AM17/ RLA File :05/23/040/00032/AM17/ Lie. No/Date:0510398379 04.05.2016 Defer Date:29.11.2016 uecisiun :Ueterred. — 339 Case No.;132/10/82- ALC4/2016 Party NameiSUVEN LIFE SCIENCES LIMITED Meet No/Date; 12/82- ALC4/2016 28.09.2016 Status;Deferred liU File RLA File Lic.No/Date:0910063583 Defer 54

01/82/050/00478/AM17/ :09/24/040/00040/AM17/ 04.05.2016 Date:29.11.2016 340 Case No.:181/10/82- ALC4/2016 Party NameiALEMBIC PHARMACEUTICALS LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 341 Case No.:9/10/82- ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00355/AIVI17/ RLA File :03/94/040/00077/AM17/ Lic.No/Date:0310804424 05.05.2016 Defer Date:29.11.2016 Decision :Deferred. 342 Case No.:6/10/82- ALC4/2016 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date; 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00352/AM17/ RLA File :05/24/040/00054/AM17/ Lic.No/Date:0510398413 06.05.2016 Defer Date:29.11.2016 343 Case No.:146/10/82- ALC4/2016 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00492/A[/l17/ RLA File :09/24/040/00044/AM17/ Lic.No/Date:0910063608 09.05.2016 Defer Date:29.11.2016 Decision : Technical information has been received and sent to DoP on 19.09.2016. The Committee accordingly deferred the case. 344 Case No.:178/10/82- ALC4/2016 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File ;01/82/050/00524/AM17/ RLA File :34/24/040/00354/AM16/ Lic.No/Date:3410042154 10.05.2016 Defer Date:29.11.2016 345 Case No.:47/7/82- ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved HQ File :01/82/050/00221/AM17/ RLA File :05/24/040/00053/AM17/ Lic.No/Date:0510398448 10.05.2016 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.35011/201/2016-Pi{Norms) dated 10.08.2016 , uploaded at the end of these minutes or as applied by the firm whichever is NC. 55

346 Case No.:77/10/82- ALC4/2016 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date; 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00423/AM17/ RLA File :13/24/040/00004/AM17/ Lic.No/Date:1310048244 11.05.2016 Defer Date:29.11.2016 Case No.:95/4/82- ALC4/2016 Party NameiAIMS IMPEX PVT. LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 347 HQ File :01/82/050/00158/AM17/ RLA File :03/94/040/00129/AM17/ Lie. No/Date:0310804639 12.05.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in Its meeting No.6/82 dated 29.08.2014. uploaded at the end of these minutes or as applied by the firm whichever Is less under para 4.07 of HBP Vol.1. RA concerned may take 348 Case No.:7'J/10/82- ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00417/AM17/ RLA File :05/24/040/00056/AM17/ Llc.No/Date:0510398495 13.05.2016 Defer Date:29.11.2016 349 Case No.:169/10/82- ALC4/2016 Party Name:BIOLOGICAL E LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusrDeferred HQ File :01/82/050/00515/AM17/ RLA File :09/24/040/00007/AM17/ Llc.No/Date;0910063629 17.05.2016 Defer Date:29.11.2016 Decision : Deterred for want of comments from DBT. 350 Case No.:94/10/82- ALC4/2016 Party Name:KLJ PLASTICIZERS LIMITED Meet No/Date; 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00440/AM17/ RLA File ;05/23/040/00067/AM17/ Lic.No/Date:0510398541 18.05.2016 Defer Date:29.11.2016 Decision :Deterrecl. 351 Case No.:126/10/82- ALC4/2016 Party Name:BIOLOGICAL E LTD Meet No/Date; 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File 01/82/050/00472/AM17/ RLA File 09/24/040/00306/AM15/ Llc.No/Date:0910063657 19.05.2016 Defer Date:29.11.2016 Dwuision : Ueterreo tor want of comments from DBT. 352 case No.:149/1IO/82- ftLC4/2016 Party Name:BIOLOGICAL E -TD Meet No/Date: 12/82- 4LC4/2016 28.09.2016 StatusrDeferred HQ File 01/82/050/00495/AM17/ RLA File 09/24/040/00546/AM16/ JC.No/Date:0910063659 " 9.06.2016 [ Defer Date:29.11.2016 56

Decision : Deferred for want of comments from DBT. 353 Case No.:72/10/82- ALC4/2016 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date;12/82- ALC4y2016 28.09.2016 Status:Deferred HQ File :01/82/050/00418/AM17/ RLA File ;05/24/040/00080/AM17/ Lic.No/Date:0510398561 19.05.2016 Defer Date:29.11.2016 Decision :Deferred. 354 Case No.:73/10/82- ALC4/2016 Party Name:VDH CHEM TECH PVT. LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision :Deferred. 355 Case No.:130/10/82- ALC4/2016 Party Name:SRINI PHARMACEUTICALS PRIVATE LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00476/AM17/ RLA File :09/24/040/00078/AM17/ Lic.No/Date:0910063664 23.05.2016 Defer Date:29.11.2016 Decision : Deferred. 356 Case No.:83/10/82- ALC4/2016 Party Name:STERILE INDIA PRIVATE LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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;29.11.2016 Case No.:177/10/82- ALC4/2016 Party Name:DEEPAK NITRITE LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 357 HQ File :01/82/050/00523/AM17/ RLA File :34/24/040/00039/AM17/ Llc.No/Date:3410042198 24.05.2016 Defer Date: by NC in Its meeting No.28/82 dated 10.01.2013, uploaded at the end of these minutes or as Case No.:180/10/82- ALC4/2016 Party Name:DEEPAK NITRITE LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 358 HQ File :01/82/050/00526/AM17/ RLA File :34/24/040/00042/AM17/ Lic.No/Date:3410042199 24.05.2016 Defer Date: by NC in its meeting No.28/82 dated 10.01.2013, uploaded at the end of these minutes or as 57

359 Case No.:79/10/82- ALC4/2016 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :ai/82/050/00425/AM17/ RLA File :05/23/040/00075/AM17/ Lic.No/Date:0510398581 24.05.2016 Defer Date:29.11.2016 360 Case No.:80/10/82- ALC4/2016 Party Name:INDO PHYTO CHEMICALS PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status;Deferred HQ File ;01/82/050/00426/AM17/ RLA File :05/23/040/00027/AM17/ Lic.No/Date:0510398587 24.05.2016 Defer Date:29.11.2016 361 Case No.;81/10/82- ALC4/2016 Party Name:INDO PHYTO CHEMICALS PVT LTD Meet No/Date:12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00427/AM17/ RLA File :05/23/040/00028/AM17/ Lic.No/Date:0510398588 24.05.2016 Defer Date:29.11.2016 362 Case No.:74/10/82- ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00420/AM17/ RLA File :05/23/040/00078/AM17/ Lic.No/Date:0510398583 24.05.2016 Defer Date:29.11.2016 Decision :Deferred. 363 Case No.:75/10/82- ALC4/2016 Party NameJUBILANT GENERICS LTD Meet No/Date:12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00421/AM17/ RLA File ;05/23/040/00076/AM17/ Lic.No/Date;0510398582 24.05.2016 Defer Date:29.11.2016 Decision ;Deferrecl. Case No.;136/10/82- ALC4/2016 Party NameiMETROCHEM API PVT. LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred 364 HQ File 01/82/050/00482/AM17/ RLA File 09/24/040/00100/AM17/ Lic.No/Date:0910063676 25.05.2016 Defer Date:29.11.2016 Decision . ine Committee decided to ratify norms on repeat basis based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/210/2016-PI(Norms) lated Sept. 2016 , uploaded at the end of these minutes or as applied by the firm whichever is ess under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of i 365 sase No.:185/1IO/82- ^LC4/2016 ='arty Name:PAUSHAK -IMITED / Weet No/Date: 12/82- \LC4/2016

8.09.2016 Status;Deferred fHQ File f 01/82/050/00531/AM17/ : ^LA File I 34/24/040/00037/AM17/ 2 .ic.No/Date:3410042207 [ 5.05.2016 [ Defer Date:29.11.2016 58

Case No.:87/10/82- ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred 366 HQ File 01/82/050/00433/AM17/ RLA File 05/24/040/00058/AM17/ Lic.No/Date:0510398614 25.05.2016 Defer Date:29.11.2016 Case No.:102/10/82- ALC4/2016 Party Name:IKRlSH HEALTHCARE PVT.LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred 3b/ HQ File 01/82/05O/0a448/AI/l17/ RLA File :05/23/040/00091/AM17/ Ljc.No/Date:0510398628 26.05.2016 Defer Date:29.11.2016 368 Case No.:68/10/82- ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD., Meet N o/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 369 Case No.:65/10/82- ALC4/2016 Party Name:KORES (INDIA) LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision :Deferred. 370 Case No.:88/10/82- ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet N o/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00434/AM17/ RLA File :05/24/040/00083/AM17/ Llc.No/Date:0510398625 26.05.2016 Defer Date:29.11.2016 Case No.:147/10/82- ALC4/2016 Party NameiSHREEGEN PHARMA LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred 3/1 HQ File :01/82/050/00493/AM17/ RLA File :09/24/040/00091/AM17/ Llc.No/Date:0910063692 26.05.2016 Defer Date:29.11.2016 Case No.:91/10/82- ALC4/2016 Party Name:VIC INDUSTRIES, Meet No/Date: 12/82- ALG4/2016 28.09.2016 StatusiDeferred 372 HQ File :01/82/050/00437/AM17/ RLA File :17/24/040/00028/AM17/ Lic.No/Date:1710006343 26.05.2016 Defer Date:29.11.2016 Decision ; Deferred . J 59

Case No.:160/10/82- ALC4/2016 Party Name:AUROBlNDO PHARMA LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 373 HQ File :01/82/050/00AM17/ RLA File :09/24/040/0G096/AM17/ Lic.No/Date:0910063702 27.05.2016 Defer Date: Decision : : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/230/2016-PI{Norms) dated Sept. 2016, of HBP Vol. 1. RA concerned may take necessary action as per decision of NC. Case No.:155/10/82- ALC4/2016 Party NameiDIVIS LABORATORIES LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 374 HQ File :01/82/050/00501/AM17/ RLA File :09/24/040/00073/AM17/ Lic.No/Date:0910063701 27.05.2016 Defer Date: Decision: The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/209/2016-PI(Norms) dated Sept. 2016, of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 375 Case No.ill 7/10/82- ALC4/2016 Party Name:DR. REDDYS LABORATORIES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00463/AM17/ RLA File :09/24/040/00089/AM17/ Lic.No/Date:0910063705 27.05.2016 Defer Date:29.11.2016 ueclsion : Deferred for want of comments from DoP. 376 Case No.:92/10/82- ALC4/2016 Party Name:ESTEEM INDUSTRIES PRIVATE LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00438/AM17/ RLA File :17/24/040/00030/AM17/ Lic.No/Date:1710006345 27.05.2016 Defer Date:29.11.2016 ueclsion : Deferred. 377 Case No.: 112/10/82- ALC4/2016 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00458/AM17/ RLA File 05/23/040/00094/AM17/ Lic.No/Date:0510398655 27.05.2016 Defer Date:29.11.2016 Decision : ueferred tor want of comments from DoP. Case ALC4/2016 No.:113/10/82- 378 HQ File :01/82/050/00459/AI/l17/ Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved Lie. No/Date:0510398654 27.05.2016 Defer Date: RLA File 05/23/040/00093/AM17/ H 7^^ Committee decided to ratify norms on repeat basis based on the riatenniR I Pharmaceuticals forwarded vide O.M. No.35011/171/2016-P[(Norms) un?er parL 4 oToThIp Vo r"a a""'""'®® ""li^hever Is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC 60

379 Case No.:45/10/82- ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date: 12/82- ALC4/2G16 28.09.2G16 Status:Deferred HQ File :01/82/050/00391/AM17/ RLA File :03/95/040/00157/AM17/ . Lic.No/Date:031G8G4995 27.G5.2G16 Defer Date:29.11.2016 Decision :Deferred. 380 Case No.:36/10/82- ALC4/2016 Party Name:FRESENIUS KABl INDIA PRIVATE LTD Meet No/Date:12/82- ALC4/2016 28.09.2G16 Status:Deferred HQ File :01/82/050/00382/AM17/ RLA File :03/94/040/00145/AM17/ Lic.No/Date:G31G8G5018 3G.G5.2G16 Defer Date:29.11.2016 381 Case No.:34/10/82- ALC4/2016 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date: 12/82- ALC4/2G16 28.09.2016 Status:Deferred HQ File :01/82/050/G0380/AM17/ RLA File :G3/94/Q4G/0G048/AM17/ Lic.No/Date:031G80501G 3G.G5.2G16 Defer Date:29.11.2016 Decision :Deferred. 382 Case No.:35/10/82- ALC4/2016 Party NameiKAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date: 12/82- ALC4/2G16 28.09.2016 Status:Deferred HQ File :01/82/050/00381/AM17/ RLA File :03/94/G40/G0G3G/AM17/ Lic.No/Date:G310805009 30.05.2016 Defer Date:29.11.2016 Decision :Deferred. Case No.:139/10/82- ALC4/2016 Party Name:NATCO PHARMA LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Approved 383 HQ File :01/82/060/00485/AM17/ RLA File :09/24/040/00110/AM17/ Lic.No/Date:0910063712 30.05.2016 Defer Date: by NC in its meeting No.07/82 dated 4.07.2015, uploaded at the end of these minutes or as 384 Case No.:123/10/82- ALC4/2016 Party NameiNIFTY LABS PVT LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 385 Case No.:44/10/82- ALC4/2016 Party Name:PRIVI ORGANICS LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00390/AM17/ RLA File :03/95/040/00128/AM17/ Lic.No/Date:0310805023 30.05.2016 Defer Date:29.11.2016 61

Decision :Deferred. Case No.:42/10/82- ALC4/2016 Party Name:SUPRIYA LIFESCIENCELTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 386 HQ File :01/82/a50/00388/AM17/ RLA File :03/95/040/00154/AM17/ Lie. No/Date:0310805017 30.05.2016 Defer Date; Pharmaceuticals forwarded vide O.M.No.35011/237/2016-PI(Norms) dated 13.10.2016, of HBP Vol.! RA concerned may take necessary action as per decision of NC. 387 Case No.:103/10/82- ALC4/2016 Party Name:AGSON GLOBAL PRIVATE LIMITED. Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 uecision iDeferred. 00 CO Case No.133/10/82- ALC4/2016 Party Name.KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00379/AM17/ RLA File :03/94/040/00044/AM17/ Lic.No/Date:0310805039 31.05.2016 Defer Date:29.11.2016 uecision : Deterred tor want of comments from DoP. Case No.:95/10/82- ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 389 HQ File :01/82/050/00441/AM17/ RLA File :05/24/040/00091/AM17/ Lic.No/Date:0510398694 31.05.2016 Defer Date: Decision 1 he committee decided to ratify norms on repeat basis based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/253/2016-PI(Norms) ess unde °para 4 i)rof°HBP Vo/?' RA less under para 4.07 of HBP VoM. RA concerned may take necessary action as per decision of case No.:20/10/82- ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 390 HQ File :01/82/050/00366/AM17/ RLA File 05/24/040/00072/AM17/ Lic.No/Date:0510398691 31.05.2016 Defer Date: ess under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of 391 Case No.:96/IO/82- ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD Meet No/Date; 12/82- ALC4/2016 28.09.2016 Status:Deferred 62

HQ File :01/82/050/00442/AM17/ RLA File |Llc.No/Date:0510398692 :05/24/040/00063/AI/l17/ |31.05.2016 Defer Date:29.11.2016 Case No.:97/10/82- ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00443/AM17/ RLA File :05/24/040/00066/AM17/ Llc.No/Date:0510398693 31.05.2016 Defer Date:29.11.2016 392 Case No.:43/10/82- ALC4/2016 Party Name:0 C SPECIALITIES PVT.LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 393 HQ File :01/82/050/00389/AM17/ RLA File :03/95/040/00169/AM17/ Llc.No/Date:0310805124 01.06.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC In Its meeting No.33/82 dated 21.03.2013, uploaded as 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 Case No.:119/10/82- ALC4/2016 Party Name:RA CHEM PHARMA LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 394 HQ File :01/82/050/00465/AM17/ RLA File :09/24/040/00113/AM17/ Llc.No/Date:0910063721 01.06.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC In its meeting No.10/82 dated 22.08.2013, uploaded as 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 395 Case No.:187/10/82- ALC4/2016 Party Name:WINDLAS HEALTH CARE PRIVATE LIMITED Meet No/Date; 12/82- ALC4/2016 28.09.2016 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:29.11.2016 396 Case No.:54/10/82- ALC4/2016 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00400/AM17/ RLA File :04/24/040/00038/AM17/ Llc.No/Date:0410162004 02.06.2016 Defer Date:29.11.2016 397 Case No.:106/10/82- ALC4/2016 Party Name:GRANULES INDIA LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved HQ File :01/82/050/00452/AM17/ RLA File :09/24/040/00115/AM17/ Llc.No/Date:0910063743 03.06.2016 Defer Date: 63

Pharmaceuticals forwarded vide O.I/l.No.35011/270/2016-PI(Norms) dated 21.10.2016, of HBP Vol.1. RA concerned may take necessary action as per decision of NO. 398 Case No.:69/10/82- ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 399 Case No.:70/10/82- ALC4/2016 Party NameJODAS EXPOIM PVT.LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 400 Case No.;48/10/82- ALC4/2016 Party Name:AGIO PHARMACEUTICALS LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00394/AM17/ RLA File ;03/94/040/00051/AM17/ Lic.No/Date:0310805268 07.06.2016 Defer Date:29.11.2016 401 Case No.:50/10/82- ALC4/2016 Party Name:AGIO PHARMACEUTICALS LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00396/AM17/ RLA File :03/94/040/00065/AM17/ Lic.No/Date:0310805269 07.06.2016 Defer Date:29.11.2016 402 Case No.:51/10/82- ALC4/2016 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00397/AM17/ RLA File :03/94/040/00196/AM17/ Lic.No/Date:0310805264 07.06.2016 Defer Date:29.11.2016 Decision : Deferred. 40? r Case No.:11/10/82- ALC4/2016 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File 01/82/050/00357/AM17/ RLA File 08/24/040/00088/AM17/ Lic.No/Date:0810138109 D7.06.2016 Defer Date:29.11.2016 |Ueui»iori ; Deterred tor want of comments from DoP. ( 404 i -ase No.;157/'i0/82- \LC4/2016 I =^arty Name:MAITHRI DRUGS PVT LTD / 1 VIeet No/Date: 12/82- , \LC4/2016 28.09.2016 3tatus;Deferred 64

HQ File :01/82/050/00503/AM17/ RLA File :09/24/040/00112/AM17/ Lic.No/Date:0910063749 07.06.2016 Defer Date:29.11.2016 Decision : Deferred for want of comments from DoP. 405 Case No.:131/10/82- ALC4/2016 Party Name:MSN PHARMACHEM PRIVATE LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File 01/82/050/00477/AM17/ RLA File ;09/24/040/00117/AM17/ Lic.No/Date:0910063750 07.06.2016 Defer Date:29.11.2016 406 Case No.:129/10/82- ALC4/2016 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 407 Case No.:59/10/82- ALC4/2016 Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00405/AM17/ RLA File :22/24/040/00016/AM17/ Lic.No/Date:2210015489 07.06.2016 Defer Date:29.11.2016 1 408 Case No.:128/10/82- ALC4/2016 Party Name:SHODHANA LABORATORIES LTD Meet No/Date; 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00474/AM17/ RLA File :09/24/040/00127/AM17/ Lic.No/Date:0910063760 07.06.2016 Defer Date:29.11.2016 409 Case No.:134/10/82- ALC4/2018 Party Name:ALPHAMED FORMULATIONS P LTD. Meet No/Date:12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File ;01/82/050/00480/AM17/ RLA File :09/24/040/00087/AM17/ Lic.No/Date:0910063771 08.06.2016 Defer Date:29.11.2016 Decision ; The Committee decided to call for copy of Master Batch formula duly authenticated by Q.C. in-charge and deferred the case. 410 Case No.:18/10/82- ALC4/2016 Party Name:ARJUN CHEMICALS PVT LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00364/AM17/ RLA File ;04/24/040/00041/AM 11f Lic.No/Date:0410162023 08.06.2016 Defer Date:29.11.2016 Decision iDeferred. 411 Case No.:158/10/82- ALC4/2016 Party Name:AUROBiNDO PHARMA LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 65

HQ File :01/82/050/00504/AI/117/ RLA File :09/24/040/00137/AM17/ Lic.No/Date:0910063769 08.06.2016 Defer Date: Decision: The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/230/2016-PI(Norms) dated Sept. 2016, of HBP Vol.1. RA concerned may take necessary action as per decision of NO. Case No.:53/10/82- ALC4/2016 Party Name:FDC LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred 412 HQ File :01/82/050/00399/AM17/ RLA File :03/94/040/00172/AM17/ Lic.No/Date:0310805303 08.06.2016 Defer Date:29.11.2016 by NC in its meeting No.18/82 dated 18.02.2015, uploaded at the end of these minutes or as 413 Case No.:111/10/82- ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved HQ File ;01/82/050/00457/AM17/ RLA File :05/24/040/00110/AM17/ Lic.No/Date:0510398753 08.06.2016 Defer Date: decided to ratify norms on repeat basis based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/253/2016-PI(Norms) dated 25.10.2016 , uploaded at the end of these minutes or as applied by the firm whichever is 414 Case No.:121/10/82- ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 415 Case No.:120/10/82- ALC4/2016 Party Name:HETERO DRUGS LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved HQ File :01/82/050/00466/AM17/ RLA File :09/24/040/00133/AM17/ Lie. No/Date:0910063783 09.06.2016 Defer Date; Decision . ine Committee decided to ratify norms on repeat basis based on the recommendation or D/o Pharmaceuticals fonvarded vide O.M. No.35011/251/2016-PlfNorms^ dated 13.10.2016 , uploaded at the end of these minutes or as applied by the firm whichever is tess under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of 416 Case No.:l:22/10/82- ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved HQ File •01/82/050/00468/AM17/ RLA File 09/24/040/00136/AM17/ Lic.No/Date:0910063784 09.06.2016 Defer Date; Uuuibiori . Ihe committee decided to ratify norms based on the recommendation of D/o 66

Pharmaceuticals forwarded vide O.M.No.35011/252/2016-PI(Norms) dated 13.10.2016, of HBP Vol.1. RA concerned may take necessary action as per decision of NC. Case No.:150/10/82- ALC4/2016 Party Name:INCHEM LABORATORIES PRIVATE LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status;Deferred HQ File :01/82/050/00496/AM17/ RLA File :09/24/040/00122/AM17/ Lic.No/Date;0910063779 09.06.2016 Defer Date;29.11.2016 417 418 Case No.;151/10/82- ALC4/2016 Party Name;INCHEM LABORATORIES PRIVATE LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision : Deferred for want of comments from DoP. 419 Case No.:49/10/82- ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Deferred HQ File :01/82/050/00395/AM17/ RLA File :03/94/040/00181/AM17/ Llc.No/Date:0310805345 09.06.2016 Defer Date;29.11.2016 Case No.:114/10/82- ALC4/2016 Party Name:SHREE BANKEY BEHARI LAL AROMATICS Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 420 HQ File :01/82/050/00460/AM17/ RLA File :05/24/040/00092/AM17/ Lic.No/Date;0510398757 09.06.2016 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.11/82 dated 26.11.2014 . uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 421 Case No.:179/10/82- ALC4/2016 Party Name: BEST VALUE CHEM PVT. LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00525/AM17/ RLA File :34/24/040/00064/AM17/ Lic.No/Date:3410042257 10.06.2016 Defer Date:29.11.2016 Decision iDeferred. Case No.:12/10/82- ALC4/2016 Party Name:CAPLIN POINT LABORATORIES LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status'.Deferred 422 HQ File :01/82/050/00358/AM17/ RLA File :04/24/040/00043/AM17/ Lic.No/Date:0410162034 10.06.2016 Defer Date:29.11.2016 67

423 Case No.:89/10/82- ALC4/2016 Party Name:ESTEEM INDUSTRIES PRIVATE LIMITED Meet No/Date:12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00435/AM17/ RLA File :17/24/040/00037/AM17/ Lic.No/Date: 1710006358 10.06.2016 Defer Date:29.11.2016 Decision :Deferred. 424 Case No.:90/10/82- ALC4/2016 Party Name:ESTEEM INDUSTRIES PRIVATE LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00436/AM17/ RLA File ;17/24/040/00039/AM17/ Lic,No/Date:1710006359 10.06.2016 Defer Date:29.11.2016 Decision iDeferred. Case No.:31/10/82- ALC4/2016 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date; 12/82- ALC4/2016 28.09.2016 Status: Approved 425 HQ File ;01/82/050/00377/AM17/ RLA File :03/94/040/00216/AM17/ Lic.No/Date:0310805373 10.06.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/213/2016-PI(Norms) dated 18.10.2016, of HBP Vol.1. RA concerned may take necessary action as per decision of NO. 426 Case Nd.:46/10/82- ALC4/2016 Party Name:NOCiL LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusrDeferred HQ File :01/82/050/00392/AM17/ RLA File :03/95/040/00134/AM17/ Lic.No/Date:0310805363 10.06.2016 Defer Date:29.11.2016 427 Case No.:47/10/82- ALC4/2016 Party Name:SUNSHlELD CHEMICALS LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00393/AM17/ RLA File :03/95/040/00196/AM17/ Lie. No/Date;0310805364 10.06.2016 Defer Date:29.11.2016 Decision iDeferred. 428 Case No.:64/10/82- ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusrDeferred HQ File :01/82/050/00410/AM17/ RLA File :31/83/040/00195/AM16/ Lic.No/Date:3110066174 13.06.2016 Defer Date:29.11.2016 Decision : Deferred. 429 Case No.:152/10/82- ALC4/2016 Party Name:RA CHEM PHARMA LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved HQ File ;01/82/050/00498/AM17/ RLA File :09/24/040/00130/AM17/ Lie. No/Date:0910063793 13.06.2016 Defer Date: 68

Decision : The Committee decided to ratify norms on repeat based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/99/2015-PI(Norms) dated Sept. 2015, of HBP Vol.1. RA concerned may take necessary action as per decision of NO. 430 Case No.:14/10/82- ALC4/2016 Party Name:CAPLIN POINT LABORATORIES LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00360/AM17/ RLA File :04/24/040/00049/AM17/ Lic.No/Date:0410162041 14.06.2016 Defer Date:29.11.2016 431 Case No.:52/10/82- ALC4/2016 Party Name:GLARIANT INDIA LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00398/AM17/ RLA File :03/94/040/00223/AM17/ Llc.No/Date:0310805476 14.06.2016 Defer Date:29.11.2016 Decision : Deferred. 432 Case No.:26/10/82- ALC4/2016 Party NameJ.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 433 Case No.:27/10/82- ALC4/2016 Party NameJ.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision : Deferred for want of comments from DoP. 434 Case No.:137/10/82- ALC4/2016 Party Name:PROCESS AGROCHEM INDUSTRIES PVT. LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision :Deferred. 435 Case No.:19/10/82- ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 436 Case No.:60/10/82- Party Name:VENUS Meet No/Date: 12/82- Status:Deferred 69

ALC4/2016 REMEDIES LTD., ALC4/2016 28.09.2016 HQ File :01/82/050/00406/AM17/ RLA File :22/24/040/00014/AM17/ Lic.No/Date:2210015501 14.06.2016 Defer Date:29.11.2016 437 Case No.:61/10/82- ALC4/2016 Party NameiANUJA HEALTHCARE LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision : Deferred for want of comments from DoP. 438 Case No.:25/10/82- ALC4/2016 Party NameiASTEC LIFESCIENCES LTD., Meet No/Date:12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File p-A File :01/82/050/00371/AM17/ 1:03/94/040/00132/AM17/ Lic.No/Date:0310805494 15.06.2016 Defer Date:29.11.2016 439 Case No.:154/10/82- ALC4/2018 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00500/AM17/ RLA File :09/24/040/00084/AM17/ Llc.No/Date:0910063799 15.06.2016 Defer Date:29.11.2016 Decision : 440 Case No.:23/10/82- ALC4/2016 Party Name:RECKITT BENCKISER ( INDIA) PRIVATE LIMITED, Meet N o/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision: 441 Case No.:57/10/82- ALC4/2016 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00403/AM17/ RLA File :05/23/040/00054/AM17/ Llc.No/Date:0510398839 17.06.2016 Defer Date:29.11.2016 442 Case No.;40/10/82- ALC4/2018 Party Name:UNIM/\X LABORATORIES PVT. LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :ai/82/050/00386/AM17/ RLA File :03/95/040/00191/AM17/ Lic.No/Date:0310805570 17.06.2016 Defer Date:29.11.2016 443 Case No.:30/10/82- ALC4/2018 Party Name:DANOPHARM Meet No/Date: 12/82- ALC4/2016 Status:Deferred 70

CHEMICALS PRIVATE LTD. 28.09.2016 HQ File ;01/82/050/00376/AM17/ RLA File :03/94/040/00150/AM17/ Llc.No/Date:0310805606 20.06.2016 Defer Date:29.11.2016 Case No.:21/10/82- ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00367/AM17/ RLA File :05/24/040/00129/AM17/ Lic.No/Date:0510398847 20.06.2016 Defer Date:29.11.2016 444 Decision : Deferred forwent of comme nts from DoP. Case No.:22/10/82- ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 445 HQ File :01/82/050/00368/AM17/ RLA File :05/24/040/00112/AM17/ Lic.No/Date:0510398846 20.06.2016 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/253/2016-PI(Norms) dated 25.10.2016 , uploaded at the end of these minutes or as applied by the firm whichever is NC. 446 Case No.:29/10/82- ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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;29.11.2016 Case No.:24/10/82- ALC4/2016 Party Name:IPCA LABORATORIES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 447 HQ File :01/82/050/00370/AM17/ RLA File :03/94/040/00230/AM17/ Lic.No/Date:0310805622 21.06.2016 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.04/82 dated 12.06.2015, 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. 448 Case No.:55/10/82- ALC4/2016 Party Name:MALLADl DRUGS & PHARMACEUTICALS LIMITED Meet N o/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00401/AM17/ RLA File :04/24/040/00052/AM17/ Lic.No/Date:0410162053 21.06.2016 Defer Date:29.11.2016 449 Case No.:78/10/82- ALC4/2016 Party Name:AMOL PHARMACEUTICALS Meet No/Date: 12/82- ALC4/2016 Status:Deferred 71

PVT. LTD. 28.09.2016 HQ File :01/82/050/00424/AM17/ RLA File :13/24/040/00QG9/AM17/ Llc.No/Date:1310048295 22.06.2016 Defer Date;29.11.2016 450 Case No.:56/10/82- ALC4/2016 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 451 Case No.:105/10/82- ALC4/2016 Party Name:MOREPEN LABORATORIES LTD.. Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 452 Case No.:109/10/82- ALC4/2016 Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 453 Case No.:66/10/82- ALC4/2016 Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00412/AM17/ RLA File :31/83/040/00030/AM17/ Lic.No/Date:3110066188 23.06.2016 Defer Date:29.11.2016 Decision : Deferred for want of comments from DoP, 454 Case No.:28/10/82- ALC4/2016 Party Name:GITANJALI CHEMICALS PVT LTD Meet No/Date:12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00374/AM17/ RLA File ;03/94/040/00202/AM17/ Lic.No/Date:0310805671 23.06.2016 Defer Date:29.11.2016 Decision :Deferred. Case No.:184/10/82- ALC4/2016 Party Name:TIDE INDUSTRIES Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status; Approved 455 HQ File :01/82/050/00530/AM17/ RLA File :34/24/040/00074/AM17/ Lic.No/Date:3410042297 23.06.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC provided earlier vide U.O. No.14010/40/2011-Ch-ll dated 4.3.2016. uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol. 1 RA concerned 72

may take necessary action as per decision of NC. 456 Case No.:110/10/82- ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date: 12/82- ALC4/2G16 28.09.2G16 Status:Deferred HQ File :01/82/050/00456/AM17/ RLA File|Lic.No/Date:3110066198 :31/83/040/00027/AM17/ |27.06.2016 Defer Date:29.11.2016 Decision iDeferred. 457 Case No.:104/10/82- ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date: 12/82- ALC4/2G16 28.09.2G16 Status:Deferred HQ File :01/82/Q5Q/G0450/AM17/ RLA File |Lic.No/Date:0510398918 :05/24/G40/00130/AM17/ |27.06.2G16 Defer Date:29.11.2016 Decision : Deferred for want of comments from DoP. 458 Case No.:37/10/82- ALC4/2016 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:12/82- ALC4/2G16 28.G9.2016 StatusiDeferred HQ File :01/82/050/00383/AM17/ RLA File :G3/95/G4G/0G258/AM17/ Lic.No/Date:G31G805756 28.G6.2G16 Defer Date:29.11.2016 Decision iDeferred. 459 Case No.:38/10/82- ALC4/2016 Party Name:ORBIT LIFE SCIENCE PVT. LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00384/AM17/ RLA File :G3/95/G40/00234/AM17/ Lic.No/Date:03108G5748 28.06.2016 Defer Date:29.11.2016 460 Case No.:39/10/82- ALC4/2016 Party Name:ORBIT LIFE SCIENCE PVT. LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00385/AM17/ RLA File :03/95/G40/00235/AM17/ Lic.No/Date:0310805747 28.06.2016 Defer Date:29.11.2016 Decision ; Deferred for want of comments from DoP. 461 Case No.:138/10/82- ALC4/2016 Party Name:PARENTRAL DRUGS INDIA LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/B2/050/00484/AM17/ RLA File :56/24/G4G/GG051/AM16/ Lic.No/Date:5610004939 30.06.2016 Defer Date:29.11.2016 Decision : Deferred for wemt of comments from DoP. 462 Case No.:182/10/82- ALC4/2016 Party NameiSHIVA PHARMACHEM LTD, Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00528/AM17/ RLA File :34/24/G40/0GG95/AM17/ Lic.No/Date:3410042315 30.06.2016 Defer Date:29.11.2016 73

Decision :Deferred. 463 Case No.:183/10/82- ALC4/2016 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00529/AM17/ RLA File :34/24/040/00094/AM17/ Ljc.No/Date:3410042314 30.06.2016 Defer Date:29.11.2016 Decision iDeferred. Case No.:100/10/82- ALC4/2016 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 464 HQ File :01/82/050/00446/AM17/ RLA File :05/23/040/00169/AM17/ Lic.No/Date:0510398969 04.07.2016 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/161/2016-PI(Norms) dated Sept.2016 , uploaded at the end of these minutes or as applied by the firm whichever is NO. Case No.:93/10/82- ALC4/2016 Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:12/82- ALC4/2016 28.09.2016 Status: Approved 465 HQ File :01/82/050/00439/AM17/ RLA File :05/23/040/00097/AM17/ Lic.No/Date:0510398980 04.07.2016 Defer Date: by NC in its meeting No.03/82 dated 08.05.2014, uploaded at the end of these minutes or as 466 Case No.:85/10/82- ALC4/2016 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision :Deferred. 467 Case No.:86/10/82- ALC4/2016 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00432/AM17/ RLA File :05/23/040/00146/AM17/ Lie. No/Date:0510398970 04.07.2016 Defer Date:29.11.2016 uectsion :Deferred. • 468 Case No.:101/10/82- ALC4/2016 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision :uererred. 74

469 Case No.:135/10/82- ALC4/2016 Party Name:PARENTRAL DRUGS INDIA LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 470 Case No.:3/8/82- ALC4/2016 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00341/AM17/ RLA File :34/24/040/00079/AM17/ Lic.No/Date:3410042326 05.07.2016 Defer Date:29.11.2016 471 Case No.:2/8/82- ALC4/2016 Party Name:HELLO PAINTS (P) LTD Meet No/Date:12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00340/AM17/ RLA File :05/23/040/00139/AM17/ Lic.No/Date:0510398996 05.07.2016 Defer Date:29.11.2016 Decision :Deferred. 472 Case No.:4/8/82- ALC4/2018 Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date: 12/82- ALC4/2016 28.09.2016 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:29.11.2016 Decision iDeferred. 473 Case No.:63/10/82- ALC4/2016 Party Name:STRlDES SHASUN LIMITED Meet No/Date:12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00409/AM17/ RLA File :04/24/040/00058/AM17/ Lic.No/Date:0410162083 08.07.2016 Defer Date:29.11.2016 474 Case No.:82/10/82- ALC4/2016 Party NameiDEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00428/AM17/ RLA File :31/83/040/00041/AM17/ Lic.No/Date:3110066246 14.07.2016 Defer Date:29.11.2016 Decision :Deferred. 475 Case No.:5/8/82- ALC4/2016 Party NameiMYLAN LABORATORIES LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 StatusrDeferred HQ File :01/82/050/00343/AM17/ RLA File :09/24/040/00197/AM17/ Lic.No/Date:0910063918 14.07.2016 Defer Date:29.11.2016 75

476 Case No.:G/8/82- ALC4/2016 Party Name:ATUL LIMITED, Meet No/Date:12/82- ALC4/2016 28.09.2016 StatusiDeferred HQ File :01/82/050/00344/AM17/ RLA File :08/24/040/00134/AM17/ Lic.No/Date:0810138308 18.07.2016 Defer Date:29.11.2016 Decision : Deferred. 477 Case No.:8/8/82- ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00346/AM17/ RLA File :09/24/040/00198/AM17/ Lic.No/Date:0910063961 20.07.2016 Defer Date:29.11.2016 478 Case No.:1/10/82- ALC4/2016 Party Name:INTAS PHARMACEUTICALS LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Deferred HQ File :01/82/050/00347/AM17/ RLA File :08/24/040/00127/AM17/ Lic.No/Date:0810138359 25.07.2016 Defer Date:29.11.2016 Case No.:188/10/82- ALC4/2016 Party Name:SAURAV CHEMICALS LTD, Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Approved 479 HQ File :01/82/050/00534/AM17/ RLA File :22/24/040/00040/AM17/ Lic.No/Date:2210015536 11.08.2016 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/134/2016-PI(Norms) dated July 2016 , uploaded at the end of these minutes or as applied by the firm whichever is 480 Case No.:1/12/82- ALC4/2016 Party Name:INTAS PHARMACEUTICALS LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Case Deferred HQ File :01/82/050/00625/AM17/ RLA File :08/24/040/00236/AM17/ Lic.No/Date:0810138639 09.09.2016 Defer Date:29.11.2016 ueclston : Deferred for want of comments from DoP. 481 Case No.:2/12/82- ALC4/2016 Party Name:ARIHANTANAM LIFECARE PVT. LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status:Case Deferred HQ File :01/82/050/00626/AM17/ RLA File :52/24/040/00039/AM17/ Lic.No/Date:5210042021 15.09.2016 Defer Date:29.11.2016 uecision : Deterred for want of comments from DoP. 482 Case No.:3/12/82- ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Deferred HQ File 01/82/050/00627/AM17/ RLA File 05/24/040/00255/AM17/ Lic.No/Date:0510399725 15.09.2016 Defer Date:29.11.2016

483 Case No.:4/12/82- ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date: 12/82- ALC4/2016 28.09.2016 Status: Deferred HQ File IRLA File :01/82/05Q/00628/AM17/ :09/24/040/00290/AM17/ Lic.No/Date:0910064145 16.09.2016 Defer Date:29.11.2016 Cases considered out of agenda Case No. B- 01 M.N0.12/AM-17 Date 28.09.2016 M/s. Alembic Pharmaceuticals Ltd. F.NO.01/82/50/1114/AM14 Adv.Auth.No.3410038534 dated 25.11.2013 Decision: The Committee considered this case for correction in the norms as per agenda. The Committee decided to ratify norms as per the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/857/2015-PI(Norms) dated 08.09.2016, 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. Case No. B- 02 M.N0.12/AM-17 Date 28.09.2016 M/s. Ashish Life Science Pvt. Ltd. F.NO.01/82/50/881/AM13 Adv.Auth.No.0310709108dated 14.09.2012 Decision: The Committee considered this case for correction in the norms as per agenda. The Committee decided to ratify norms as per the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/153/2014-PI(Norms) dated October 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. Case No. B- 03 M.N0.12/AM-17 Date 28.09.2016 M/s. Reliance Industries Ltd File No. 01/82/050/01358/AM15 Adv.Auth. No. 0310792858 dated 13.01.2015 Adv.Auth. No. 0310792860 dated 13.01.2015 Adv.Auth. No. 0310792863 dated 13.01.2015 Decision: The Committee considered this case for clarification of the export product Orthoxylene 98% and Orthoxylene as per agenda. The Committee decided to clarify that the export product Orthoxylene 98% refers to purity of the Orthoxylene. The Committee also decided to clarify that firm's request for pro-rata reduction in the input eligibility reducing by 2% on pro-rata basis as per the General Note 2 of Chemicals & Allied Products is allowed RA concerned may take further necessary action as per the decision of NC. 77

Case No. B- 04 M.N0.12/AM-17 Date 28.09.2016 M/s. Reliance Industries Ltd File No. 01/82/050/01385/AI/l16 Adv.Auth. No. 0310799215 dated 06.10.2015 Decision: The Committee considered firm's request dated 10.05.2016 for correction in the description of import item from "Reformate Relevance Catalyst and Chemicals used in manufacture of Orthoxylene (CIF value of 90% of FOB value of export" to "Reformate Relevant Catalyst and Chemicals used in manufacture of Paraxylene (CIF value of 0.90% of FOB value of export". The Committee decided to correct the description of import items to read as "Reformate Relevant Catalyst and Chemicals used in manufacture of Paraxylene (CIF value of 0.90% of FOB value of export" without any other change In the quantity. RA concerned may take further necessary action as per the decision of NC. Case No. B- 05 M.N0.12/AM-17 Date 28.09.2016 M/s. Wanbury Ltd File No. 01/82/050/706/AM14 Adv.Auth. No. 0310745576 dated 16.08.2013 The Committee considered firm's request dated 21.09.2016 received through PC-4 Division of DGFT for ratification of norms as per agenda. The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.08/82 Case No.B-03 dated 16.09.2015, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. Case No. B-06 M.N0.12/AM-17 Date 28.09.2016 M/s. DSM Sinochem Pharmaceuticals India Pvt Ltd File No. 01/82/050/00645/AM 07 RLA No. 22/24/040/00152/AM07 Adv Auth No. 2210005831 dated 31.07.2006 uecision. ine Committee considered the representation of the firm for amendment of import items as per agenda. The Committee decided to allow the import items as SION A-33 as requested by the firm RA concerned may take fun:her necessary action as per the decision of NC. Case No. B-07 M.N0.12/AM-17 Date 28.09.2016 M/s. DSM Sinochem Pharmaceuticals India Pvt Ltd File No. 01/82/050/00056/AM 08 RLA No. 22/21/042/00006/AM05 Adv Auth No. 2210006467 dated 02.02.2007 u«oibion. 1 he uommittee considered the representation of the firm for correction/revision of norms as per agenda. The Committee decided to revise/ratify norms as per SION A-68. RA concerned may take further necessary action as per the decision of NC. case No. B-08 M.N0.12/AM-17 Date 28.09.2016 M/s. DSM Sinochem Pharmaceuticals India Pvt Ltd File No. 01/82/050/01155/AM 12 RLA No. 22/24/040/00061/AM 12 Adv Auth No. 2210012197 dated 22.11.2011 .

^ «-'i uic iiiin luf uorreciion/revision or norms as nar Mf^n/Ro decision taken by NC in its meeting mav?akp f rth up'oaded at the end of these minutes or as applied by the firm. RA concerned may take further necessary action as per the decision of NC. 78

Case No. B-09 M.N0.12/AM-17 Date 28.09.2016 M/s. DSM Sinochem Pharmaceuticals India Pvt Ltd File No. 01/82/050/00970/AM 11 RLA No. 22/24/040/00022/AM11 Adv Auth No. 2210010238 dated 04.08.2010 Decision- The Committee considered the representation of the firm tor correctionyrevisiuii ^ noiiiib diiwuy raS The Mttee decided to ratify norms as per the earlier decision taken by NC .n its meeting No.41/82 dated 1101.2011. uploaded at the end of these minutes or as applied by the firm. RA concerned may take further necessary action as per the decision of NC. Case No. B-10 M.No.12/AI/l-17 Date 28.09.2016 M/s. DSM Sinochem Pharmaceuticals India Pvt Ltd File No. 01/82/050/00463/AM 10 RLA No. 22/24/040/00076/AM09 Adv Auth No. 2210008911 dated 11.05.2009 Decision- the Committee considered the representation of tiie liiiii 1^' ratified. The Committee decided to ratify norms as per the earlier decision taken by NC 9 No.40/82 dated 04.01.2011, uploaded at the end of these minutes or as applied by the firm. RA concerned may take further necessary action as per the decision of NC. Case No. B-11 M.N0.12/AM-17 Date 28.09.2016 M/s. DSM Sinochem Pharmaceuticals India Pvl Lid File No. 01/82/050/01019/AM 13 RLA No. 22/24/040/00038/AM-13 Adv Auth No. 2210013370 dated 30.10.2012 nf the firm for correction/revision of norms already may take further necessary action as per the decision of NC. 79

c?l F. NO.35011/130/2016-PI (Norms) Government of India Ministry of Chemical & Fertilizers Department of Pharmaceuticals Udyog Bhawan, New Delhi, Dated:^^October, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.1) 2009-14 Case of M/s Rakshit Drugs Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/133/AM-17/DES- 3/188 dated the 4/7/16 vide which application from M/s Rakshit Drugs Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Famotidine Crude. This department has examined the matter and the following norms are furnished under para 4.7 of Fland Book of Procedures (Vol.1) 2009-14:- S.No. Import Item Norms Recommended for 1kg Export 1 Guanyl Thiourea 1.794kg 2 Thiourea 1.471kg 3 Sulfamide 1.088kg A 2. This issues with the approval of competent authority. (Rajkumar) Under Secretary to the Government of India PH:-23071162 Directorate General of Foreign Trade, Department of Commerce, (S.hri M.V. Singh, FTDO), Udyog Bhawan, New Delhi. i

V F. NO.35011/107/2016-PI (Norms) Government of India r /

/ l2J^i Dated: August, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.1) 2009- 14 Case of M/s Adoock Ingram Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/122/AM- 17/DES-3/102 dated the 23/5/16 vide which application from M/s Adcock Ingram Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of CAL-SUP Tablets (calcium + carbonate 1250mg + glyclne 535.7mg). This department has examined the matter and the following norms are furnished under para 4.7 of Fland Book of Procedures (Vol.1) 2009-14:- DGFT is advised to call the following from the firm viz:-

1. Copy of the application in prescribed proforma.
2. Copy of DML for above export product, and
3. Copy of the master-batch formula duly certified by Q.C. incharge.

(Rajkumar) PH:-23071162 (Shri M.V. Singh, FTDO),

oC^ 250 Case No.:62/4/82-ALC4/2013 Party Name:UNITED PHOSPHORUS LTD. Meet No/Date:4/82- ALC4/2013 16.05.2013 Status: Case Approved HQ File ;01/82/050/a0103/AM14/ RLA File :03/95/040/00955/AM13/ Lic.No/Date:0310727648 11.03.2013 Defer Date: Decision : In the light ol was decided to ratify noi applied by the firm, whic earlier decision taken in meeting no. 31/82 dated 21.2.2013, it ms under Para 4.7 of HBP vl as per details given below or as lever is less: 1 Export Product Export Quantity S.No Import Product Quantity Allowed 1 Phenyl Chloroformate 1 kg 1. Phenol 0.666 kg 2. Ethylene Dichloride 0.292 kg KA may take appropriate action as per the decision of Norms Committee,

iCase No.;9/16/82- IALC4/2011 Party Name:ALCHEM ^INTERNATIONAL LTD. 94 HQ File :01/82/050/00467/AM12/ iRLA File i:05/23/040/00121/AM12/ Meet No/Date;24/82- ALC4/2011 13.09.2011 Status:Case Approved Lic.No/Date:0510295547 04.07.2011 Decision : Committee considered case as per agenda and in light of its earlier decision taken in its 41/82 meeting held on 11.01.2011 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- I t Export product Export Quantity SI.No. Import item? Total Quantity Digoxin 1 Kg. 1. Digitalis Lanata Leaves 444.4 kg RA concerned may take further necessary action as per above decision of NO.

z Case No.:48/21/82- ALC4/2011 HQ File :01/82/060/00630/AM12/ Party Name:GLOBAL CALCIUM PRIVATE LIMITED. RLA File :07/24/040/00140/AM12/ Meet No/Date:21/82- ALC4/2011 23.08.2011 Lic.No/Date:0710080871 25.07.2011 Status: Case Approved 79 Decision : Committee considered case as per agenda and in light of earlier decision taken in 46/82 meeting held on 09.02.2010 and in consultation with technical authority present in meeting, decided to fix norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Exp. Qty. SI. No. Import items Qty. allowed Calcium Levulinate 1 Kg. 1. Levulinic Add 0.954 kg RA concerned may take further necessary action as per above decision of NO.

(If 2^5 -T^ Government of India Ministry of Chemicals and Fertilizers Department of Chemicals and Petrochemicals Subject. Advance Authorization application from M/s. P.i Industries Ltd. Ltd. for the import of raw material against the export of Ethyl 4-Chloro-2 Fluoro- 5[ {(isopropyl) (methyl)] amino] sulfonyl}Amino) carbonyl] phenylcarbamate (PCM). (Advance Authorization No. 1310047575 dated 12.08.2014) DGFT File No. 01/82/50/00818/AM-15 dated 27.11.2015 M/s. P.I Industries Ltd. have submitted present application for the import of raw material against the export of Ethyl 4-Chloro-2 Fluoro- 5[ {(isopropyl) (methyl)] amino] sulfonyljAmino) carbonyl] phenylcarbamate (PCM). The application have been examined and the Department recommends the following norms for the present Advance Authorization application.

1. Item of Export Qty. item of import Qty Ethyl 4-Chloro-2 Fluoro- 5[ {(isopropyl) (methyl) amino] sulfonyl}Amino) carbonyl] phenylcarbamate (PCM). 1 kg. 1.2- Chlofo-4- Fluoro Toluene 0.933 Kg
2. Methyl Iso Propyl Amine 0.328 Kg.
3. Noblyst (R) P8086 1% (Pt/C Catalyst (+1%PT +2% V/C. 64% H20)) or Catalyst (+0.8% PT - 0.3% MoCP) 0.005 Kg.
4. Methanol 1.797 Kg.
5. Toluene 0.595 Kg.
6. Ethyl Chloroformate 0.389 Kg.
7. Sulfuryl Chloride 0.679 Kg.
8. n-Hexane 1.097 Kg. (A.K. AGARWAL) Addl. Industrial Adviser Tel. No. 011-2338 1430 iri Nirmai Kumar. Dv. DGFT. (DES-III) O/o DGFT. Udvog Bhawan.New Delhi-11. Deptt. of C&PC U.O. No. 15022/6/2010-CH-ll dated 10.08.2016

\A Case No.:29/13/82-ALC4/2012 Party Name: WEST BENGAL CHEMICAL INDUSTRIES LIMITED Meet No/Date: 16/82- ALC4/2012 16.08.2012 Status:Case Approved HQ File :01/82/050/00364/AM13/ RLA File :02/24/040/00038/AM13/ Lic.No/Date:0210I78D26 30.05.2012 Defer Date: 290 Decision : In the light of written comments received from Department of Chemicals and Pefrochemicals vide their U.O No. 14010/98/2010-Ch. II dated 3.1.2011, it was decided to ratify norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less: Export Product Export Qty. SI.No. Import items Qty. allowed Sodium Butyrate 1 kg 1. N-Butyric Acid 0.842 kg RA may take appropriate action as per the decision of Norms Committee.

z Case No.:72/17/82-ALC4/2013 Party Nanie:RA CHEM PHARMA LIMITED Meet No/Date:23/82- ALC4/2013 06.03.2014 Status:Case Approved HQ File :01/82/050/00934/AM14/ RLA File :09/24/040/00413/AM14/ Lic.No/Date:09I0058435 03.12.2013 Defer Date: 222 loivwi lu iiiccuiig iiu. j^dL uatea z/.uj.zuiz, it was decided to ratify norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less: Export Product Export S.No. Import Product Quantity Quantity Allowed kg/kg I kg 1. 3-Chlorpropionyl 1.16 Chloride 2. Benzonitrile 1.00 Oxolamine Citrate Ra may take appropriate action as per the decision of Norms Committee.

F. NO.35011/362/2015-PI (Norms) Government of India Shastri Bhawan. New Delhi, Dated the 19*^^ November, 2015 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Voi 1) 2009-14 I Application fom M/s Sentiss Pharma Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/226/AM-16/DES-3/323 dated the 02/07/15 vide which application from M/s Sentiss Pharma Pvt. Ltd was sent to this Department for fixation of norms for the export of Eye solution based on Olopatadine 0.1% in 5 ml vial. This department has examined the matter and following norms are recommended against this application. SI. No. Raw material to be imported Quantity Recommended 1 Olopatadine FiCL 5.817 gm for 1000 vials of eye solution 0.1% in 5 ml vials 2. X. ' a- X (Raj Kumar) Phone;-23071162 Directorate General of Foreign Trade. (Shri M.V. Singh. FTDO), Udyog Bhawan, New Delhi

/r' 4. II

souuM .I'or in^poTl hM been ipccificd In Ihc pcrmli^n Idler. • s I In.onse of Advance AiJihorlzdion for AnnucI R^qulrcmcnls, daicnunl o! exports mcdfe In the , receding licon/tg ycer duly ccrtilie;d,by « Chartered Aceouniant/.Cojt «nd Worlfs Accotiniani in UK loT ^a( given in Appendix 26 / J • r / 9 I In CQ-c of inlermcdiitie suppjio, io an Advance Vulhorisation holder, jnvahdciiion leticr (in orniinftl) • / 10 In case of other calcBortes of deemed ' cx/orts, (for supplies to pr^r^ccis), whether Project Authority Ccrtin^te .fumishcd - (note 1 1 i'-or supply ^^EOU/EH^ cop/of Green Card showing validity of EOU/ EHTP/SIP/QTP and [/egal Undcrteking of EOU With Dcve opment Commlssioner-indio/ting the item to be supplied AS one of (h<s inpuis / I 2 lit case of Advance Authorisaiion un^er Pwj 4,7,of HBPVol,I( No Nortns cat«iRory),'Ap'p4ndix'l 1A " / • 13

! 4- In case of Advance Authorisation l/nder Por« d,?, of HBP Vol.) (No' _Norms ciucgory) on repeat basis, /ody rirari.hoc.norms ' Ln_c^,gLaBjt|ieatien ..uridiLj)^ d.7' of HBP I Vnl.l fblo Norms Catepry), dcclaratiort/undcrlnking in Ic-rms bf Trade Noliee No..l/AM-tl6 dated 6.7.200Jyfjiucd. by Mumbal orricc' has been lurnishcd. / 15 I OcclaratiQn as per Tfadc J^oiicc H6.n/AiVl-05 HaUd 10.3.2005 rc-Uiing to iUms reserved Yor jmpona b.y Sintc Trading.enterprises have bccr^ furnished. / I 6 Declaration regarding O'xonc Depleting Silbslflnce (ODS) as per Trade Notice No. VAM.l I read with d/AM.ll issued by Mu^ba; oJTicc hns been fumisb'cd. Ml Informnllon / I Applicable fee In/erms of Appendix 21 B fAmounl in Rs.) 2 Amount of Application fee dcEXJiilcd ihrouch EFT 3, If Monufactur/r Exporter, which of the cxp^?rt l-temJ flcc covered undent SSl/IEM/lndusiriBl licence su&raitTed 4 If Mcrchnn-f Exporter, which of (he cxj^Tt items ore' covered m(dcr SSj/IEM/ Industrial Licence of fupponkg ninnufny(ircr submitted ' . / ' For ^naitec Labs FrivAiii 1 I JiMOisd-iiigtiatorfXDirtetv I SIgnflUirc olthc applicfini N ivrne I Dwigrifltion E-m'ftjl

a F. No.35011/662/2012-PI (Norms) Government of India Ministry of Chemical & Fertilizers Udyog Bhawan, New Delhi, the 12^'' March, 2013 Office Memorandum Subject:- Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.1) 2009-14 Case of M/s. Aurbindo Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/685/AM13/DES-3/874 dated the 09/10/12 vide which an application from M/s. Aurbindo Pharma Ltd was sent to this Department for fixation of norms under para; 4.7 for the export of Benazepril Hydrochioride. This department has examined the matter and the following comments are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S.No. Import Item Qty. Recommended kg/kg. lA: (R)-2-Hydroxy-4-phenyl butanoic acid ethyl ester 0.704 v/- 4-Nitrobenzensulfonyl Chloride 0.893 Activated Carbon 0.033 h/ 4.— Hexaiies" " .^5.—Potassium Carbonate 0.1/32 Tert-Butyl (S)-3-Amino Capralactum 0.826 7. Toh^ 2.1^ Triethylamine CO 2. This issues with the approval of Director (Cost). (N.N.Ahuja) Section Officer PI-Norms (Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi.

11 F. No.35011/3I3/2015-PI (Norms) Government of India Ministry of Chemical & Fertilizers New Delhi, the Udyog Bhawan, November, 2015 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s Softgei Healthcare Pvt Ltd. The undersigned is directed to refer to DGFT U.O.No. 0I/82/50/97/AM-I6/DES-3/45 dated the 11/06/15 vide which application from M/s. Softgei Healthcare Pvt Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Krill Oil 500mg (Softgelatin Capsules Krill Oil SOOmg). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S. No. Import Item Qty. Recommended. 1. Krill Oil (Superba Krill Oil) 510mg/500mg capsule "(Raj Kumar) Phone:23071162 GovenmrenroTlndia

F. No.35011/321/20I5-PI (Norms) Government of India Ministry of Chemical & Fertilizers New Delhi, the Udyog Bhawan, November, 2015 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s Softgel Healthcare Pvt Ltd. The undersigned is directed to refer to DGFT U.O.No. 0I/82/50/98/AM-16/DES-3/31 dated the 11/06/15 vide which application from M/s. Softgel Healthcare Pvt Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Isocap 10 (Soft Capsule Isotretinoin lOmg). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S. No. Import Item Qty. Recommended. 1. Isotretinion BP/USP 10.2mg/1 Omg capsule And 20.4mg/20mg capsule (Raj Kumar) Phone:23071162

-z 13 F. No.35011/310/2015-PI (Norms) Government of India Ministry of Chemical & Fertilizers New Delhi, the Udyog Bhawan, October, 2015 Office Memorandum Subject: - Fixation of noims under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s Softgel Healthcare Pvt Ltd. datedthi 01/82/50/99/AM-16/DES-3/29 Denlrtlfem t aPP'"=f from M/s. Softgel Healthcare Pvt Ltd was sent to this I iver on RP ^nn 1^" of norms under para; 4.7 for the export of Soft Gelatin Capsules COD Liver Oil BP 300 MgfSeven Oceans). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S. No. Import Item Qty. Recommended. 1. COD Liver Oil (Type B) 306.0mg/300mg Capsule (Shri M.V. Singh, FIDO), (Bamali Khastgir) Phone:23071162

'2^ F.NO.35011/220/2016-PI (Norms) Government of India Dated: October, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of WI/s Aarti Industries Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/738/AM-17/DES- 3/319 dated the 12/7/2016 vide which application from M/s Aarti Industries Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Benazeprii Hcl. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S.No. Import item Norms Recommended for Ikq Export 1 (R)-2-hydroxy-4-phenylbutanoic acid ethyl ester 0.684kq 2 T-butyl-3s-amino-2,3,4,5-tetrahydro-L-H-(1)- benazepin-2-one L-acetate 0.808kg 2. (Rajkumar) PH:-23071162

fy' 'm^iy''' '' ^ t I Fr i' i /'^ Government of India M/nistry of Chemicals and Fertilizers [Department of Ghemicais and Petrochemicals /V ^!-Z e<^ Subject; against thtSort'orolSo™^ the ^xpo'J'dehydro of raw material against tleyeStd:at recommends the ;o,lowing norms for (Advance Authorization No. 0810134726 dated 4 3 9n1n^ (Advance Authorization No. 0810134727 dated 4.3.2015) Item of Export Qt i/ I- ^ f SULFONICACID I'OLUIDINE y. 1 kg Item of Import

1. para TOLUIDINE (Advance Authorization No. 0810133394 datPd 1QQnn.-, ^ v lAdvance Authorization Nn n« n f !9-®-2014)v/ Advance Authorizatinn ^0 Qty 1.852 kg 1 I item of Export LAPOX ARD-13. . 0810135435 dated 5.6.2015^ Qty Item . 1 kg of import
2. PALMlR0nz^l4 LAURYL-MYRlSTYi ALCOHOl'i Sf" "URVL MYRISTYL 0.812 kg 0.440 kg
3. Item of Export uo 1 Qty. dated 27.1 2015^ Item of Import MKUMA nc AMINES 1 kg
4. METHANOL
5. AN1LINE~~ Uty 0.240 kg 1.00 kg 4.4'-DIAMIN0 DIPHENYL SULPHONE-(HT 9664-1 NL) QS^. Item of ImpoTT 1 kg DIPHENYL SULPHONE- L/KUUE This Issues with the approval of competent authority. Qty 1.03 ko (A.K. AgAi^WAL) Addl. Industrial Adviser Tel. No. 011-2338 1430 Shri MahenderVikram .Sinnh FTpn fnES-llh O/n nr^rr i i,.j ol.

F. NO.35011/759/2015-PI (Norms) Government of India Dated: April. 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14 Case of Ms Vision Drugs Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1285/AM- 16/DES-3/1228 dated the 15/12/15 vide which application from Ms Vision Drugs Pvt_ Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Homo Veratronltrile(HVN). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S.No. Import Item Norms Recommended for 1ka Export 1 Veratrole 1.231kq 2 Sodium Cyanide 0.90kg 3 Paraformaldehyde 0.423kq 4 Methanol 0.46ka 5 Chloroform 1.385kq 2. (Rajkumar) PH:-23071162 (Shri M.V. Singh. FIDO).

F. No.35011/207/201,6.PI (Norms) Government of India'| Departmerit of Pharmaceiiticals Office Memorandurri Subject: - Fixation of norms under para 4.7 of Fland E Case of IW/s' BTL Exports (P) Ltd. Udydg Bhawan, New Delhi, Dated: ''^ September, 2016 ook of Procedures (Vol.!) 2009-14 The undersigned is directed to refer to DGFT U.O.No. 01/82/50/104, 1005, 1842/AM-17/DES^3/3,15, 316, 317 dated the 29/7/16 vide which application from M/s BTL Exports (P) Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Ascorbic acid coated BP. This departmerltihas examined the matter and the following norms are furnished under para 4.7 of Hand Book of Proc^ures (Vol.!) 2009- 14:- ; DGFT is advised to call following details from the firmjviz:- j

1. Copy of valid drug manufacturing license for the export|,product with approved composition. I I
2. Firm has shown 5% wastage in one application and 22P/o wastage in another application. Justification for such' variation may be furnished.
3. Firm has shown use of 50 liters of steafy'l alcohol with 1000kg ascorbic acid in flow diagram. However, in the Ca! certificate, it is shown as 1:1 by weight. Technical justification for such variation may be furnished. Actual content of steary! alcohol in export prodi^ct may be furriished.
4. CoA/Test report of the export product vis-a-vis specification given in British Pharmacopoeia may be furnished. i
5. Past production vis-a-vis actual consumption of import item duly certified by Central Excise Authorities may be furnished.

This issues with the approval of competent autlority. (Rajkumar) PH:-23071162 (ShriM.V. Singh,, FTDO),

L 149 Case No.:16/6/82-ALC4/2014 Party Name:BLUE CIRCLE DRGANICS PVT. LTD. Meet No/Date:6/82- ALC4/2014 29.08.2014 Status: Approved HQ File :01/82/050/00418/AM15/ RLA File 03/94/040/01086/AM14/ Lic.No/Date:0310776779 02.04.2014 Defer Date: Decision : Committee considered the case as per agenda and in the light of earlier decision taken in meeting no. 33/82 dated 21.03.2013, it was decided to ratify norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. SI.No. Import items Qty. allowed 5-Nitro Isophthalic Acid Dimethyl Ester or Dimethyl 5-Nitroisophthalate 1 kg 1. Isophthalic Acid 0.857 kg

^A F. NO.35011/129/2016-PI (Norms) Government of India \i^ Dated; 1?) July, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009- 14 Case of M/s Sun Pharmaceuticals Industries Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/72/AM-17/DES- 3/189 dated the 4/7/16 vide which application from M/s Sun Pharmaceuticals Industries Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Clarithromycin Carbomer Granule 27.5%/28%. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14:- S.No. Import item Norms Recommended for 1kg Export 1 Clarithromycin 0.2777kg 1 2 Carbopol 974P 0.20kg 2. (Rajkumar) PH:- 23071162 Department of Commerce.

i
/ 1^7- F. NO.35011/783/2015-PI (Norms) Government of India Shastri Bhawan, New Delhi, Dated: July 14, 2016 Office Memorandum Sub: - Fixation of norms - Application of M/s Encube Ethicals Pvt. Ltd. The undersigned is directed to refer to DGFT U.O. No. 01/82/050/01083/AM- 16/DES-3/1190 dated 09/12/2015 forwarding an application of M/s Encube Ethicals Pvt. Ltd for fixation of norms against export of Medictioice Heatrub Ointment 100 gm (containing Eucalyptus Oil 1.05% w/w as API). This department has examined the matter and the following norms are furnished: - rruuuuL lu wc 1- Deschption Quantity S.No Description Quantity per 100 tubes Medichoice Fleatrub Ointment 100 gm (containing Eucalyptus Oil 1.05% w/w as API). 100 tubes 1. Chlorophyll Oil Soluble 70.00 gm 2. Birch Oil Sweet 16.35 gm 3 Cajuput Oil 12.65 gm 4. Eucalyptus Oil 10.71 gm 5. Aluminium Tubes for 100 qm Ointment Relevant, As per packing policy 2. This issues with the approval of Director (Pharma Industry). (Raj Kumar) Phone: 23071162/Uspi3-Pharma@nic.in (Shri MV Singh, FTDO).

/ I /Jo Case No.:217/10/82- ALC4/2013 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date: 12/82- ALC4/20]3 19.09.2013 Status:Case Approved HQ File :01/82/050/00400/AM14/ RLA File ;34/24/040/00029/AM14/ Lic.No/Date:3410036850 13.05.2013 Defer Date: j ... ...« ..Q..^ i^wwivww* (iwiM pu I ci I lu 11 ^ v( ici t nca 1.9 ai iu |Petrochemicals vide their U.O No. 14010/58/2013-Ch. II dated 30.08.2013, it was decided to 'ratify norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, iwhichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Iso Amyl Salicylate 1 kg 1. iso Amyl Alcohol 0.470 kg 2. Salicylic Acid 0.737 kg

F. NO.35011/815/2015-PI (Norms) Government of India 133 Shastri Bhav^an, New Delhi Dated; September 6, 2016 Office Memorandum Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14, Application of M/s Shalina Laboratories Pvt. Ltd. The undersigned is directed to refer to DGFT U.O. No. 01/p/050/01532/AM- 16/DES-3/1636 dated the 16/02/2016 vide which an application from M/s Shalina Laboratories Pvt. Ltd. was forwarded to this Department for fixation of norms for the export of Betasol Lotion 30 ml This department has examined the r^atter along w4h addkional information forwarded by the DGFT on 17- May 2016, vide the. OM No^ 01/82/162/29/AM-16-3/71 about a similar application of the applicant Based on the additional information following norms are recommended against this application. - Export Item Quantity S.No Import Item Quantity allowed for 1000 bottles Betasol Lotion 30 ml (contains Clobetasol Propionate equivalent to Betamethasone 15.30 mg) 1000 bottles 1. Betamethasone 15.300 gm 2. Propylene Glycol 18000.00 gm 2. (Raj Kumar) Phone:23071162 Email: iispi3-Dharm3@nic.in Directorate General of Foreign Trade. Department of Commerce. (Shri MV Singh, FTDO). Udyog Bhawan. New Delhi-110011.

Case No.:180/6782- ALC4/2014 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date;4/82- ALC4/2015 12.06.2015 Approved HQ File ;01/82/050/00582/AMI5/ IRLA File i:34/24/040/00298/AMI4/ Lic.No/Date:341003960: 19.03.2014 Defer Date: 28 Decision The committee decided to ratify the norms based on the recommendation of Department of C&PC vide U.O.No.l4010/58/2011-Ch-ll dt. 17.6.2015 as per details given belotw or as applied by the firm whichever is lower:- Export product Qty Import item Qty. K.g/kg Methyl Octine Carbonate 1kg 1-Octyne 0.834kg l-pentanol4M-Amyl alcohol 0.795 kg RA may take further action accordingly.

F. No.35011/854/2015-PI (Norms) Government of India Ministry of Chemicals & Fertilizers Shastri Bhawan.New Delhi. Dated the Septembers, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures about request of M/s Encube Ethicals Pvt. Ltd., Mumbai. The undersigned is directed to refer to DGFT U.O.No. 01/82/050/01535/AM- 16/DES-3/1693 dated the 19.02.2016 vide which application from M/s. Encube Ethicals Pvt. Ltd., Mumbai was sent to this Department for fixation of norms under para: 4.7 for the export of Fusidic Acid 2 % cream 15 gm tubes. This department has examined the matter and following norms are furnished: - Export Item Quantity 8. No. Raw material Description Quantity Recommended for 100 tubes Fusidic Acid 2 % cream 15 gm tubes. 100 tubes 1. Fusidic Acid Micronlzed 0.3060 gm 2. White Soft Paraffin (Petrolatium Jelly) 2.2500 gm 3. Liquid Paraffin (Mineral Oil Kyadol) 0.9000 gm 4. Empty Aluminium Tube 15 gm. Relevant and may be allowed as per packing Policy. 2. (Raj Kumar) Phone:-23071162 Email: uspi3-pharma@nic.in (ShriM.V. Singh, FTDO),

F.No.35011/860/2015-Pf (Norms) Government of India \bo Dated: ]:j, October, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14 Case of M/s Aurobindo Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1130/AM-16/DES- 3/1805 dated the 15/3/2016 vide which application from M/s Aurobindo Pharma Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Amoxicillin and Clavulanate Pot. lOOOmg Tablets. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S.No. Import item Norms Recommended for INo. Tablet 1 6-APA 581.77mq 2 D(-)para hydroxyl phenyl glycine base 480.06mg 3 Methyl acetoacetate 365.45mg 4 Methanol 299.28mg 5 Triethylamine 29.70mg 6 Methylene chloride 338.Omg 7 Isopropyl alcohol 431.20mg 8 N,N-dimethyl acetamide 101.40mg 9 PivaloyI chloride 338.0mg 10 Clavulanate Potassium + Avicel / Pot. Clavulanate diluted with microcrptelline cellulose (1:1) (in active base) 129.67mgA 2. (Rajkumar) PH:- 23071162 (Shri M.V. Singh. FTDO),

Sub: - F. NO.35011/858/2015-PI (Norms) Government of India Ministry of Chemlcai & Fertilizers Shastri Bhawan, New Delhi, Dated: September 8, 2016 Office Memorandum Fixation of norms under para 4.7- Application of M/s J.B. Chemicals & Pharmaceuticals Ltd. The undersigned is directed, to refer to DGFT U.O. No. 01/82/50/01562/AM-16/DES-3 /1700 dated the 19.02.2016 vide which an application from M/s J.B. Chemicals & Pharmaceuticals Ltd was sent to this Department for fixation of norms against export of various lozenges under brand name Septolete containing Cetylpyridinlum Chloride as API and Isomalt ST-IVi as excipient. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14: - Product to be Exported Raw materials to be Imported S.NO Description Quantity Description Quantity for 100 lozenges 1. Septolete Lozenges, Septolete Extra Lozenges, Septolete. Ultra Lozenges, Septolete Omni Lozenges, Septolete Total Lozenges, Septolete Duo Lozenges and Septabene Lozenges (each lozenge contain 1 mg Cetylpyridinium chloride & 2580.550 mg isomalt ST-M) 100 lozenge Cetylpyridinium Chioride 0.102 gm Isomalt ST-M 258.055 gm 2. This Issues with the approval of competent authority. (ShriMV Singh. FTDO), (R^Kumar) Phone:23071162 Uspi3-Pharma@nic.in

F. NO.35011/842/2015-PI (Norms) Government of India Shastri Bhawan, New Delhi Dated: September 6, 2016 Offinp Memorandum sub- Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14, Application of Wl/s Jubilant Generics Ltd. The undersigned is directed to refer to DGFT U.O. No. 01f2/050rai496/A^ 16/DES 3/1711 dated the 02.03.2016 vide which an application from M/s Jubilan « Ltd.':astrwarded to this Department f- Candesartan HCTZ 16 mg tablets and (2) Candesartan HCTZ 32 mg taoiexs. department has examined the matter and the following norms are furnished. - s No. Export Item Quantity Import Item Quantity allowed for 1000 Nos. 1. Candesartan HCTZ 16 mg tablets 1000 Nos. 1000 Nos. Candesartan Candesartan 16.00 gm 32.00 gm 2. Candesartan HCTZ 32 mg tablets 2. (Raj Kumar) Phone; 2307ilbz Email: iispi3-nharma@nicjn (Shri M V Singh, FTDO), Udyog Bhawan, New Delhi-110011.

f'' 1 f VJ ili.-^97- Case No.: 163/33/82- ALC4/20I2 Party Name;HINDUSTAN POLY AMIDES & FIBRES LIMITED Meet No/Date;4/82- ALC4/2013 16.05.2013 StatusrCase Approved HQ File :0I/82/050/01310/AM13/ RLA File :03/94/040/00972/AM13/ Lic.No/Date:0310724040 13.02.2013 Defer Date: . 219 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/90/2011-Ch. II dated 10.5.2013, it was decided to ratify norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. SI.No. Import items Qty. allowed Para Tertiary Butyl Cyclohexyl Acetate 1 kg 1. Para Tertiary Butyl Phenol 0.820 kg 2. 5% Ruthenium on Carbon Catalyst 0.00003 kg 3. Acetic Acid 0.300 kg 4. Methanol 0.330 kg RA may take appropriate action as per the c ecision of Norms Committee.

282 Jiz Case No.:7/15/82-ALC4/2014 HQ File :01/82/050/01294/AMI5/ Party Name;NATCO PHARMA LIMITED RLA File :09/24/040/00385/AMI5/ Meet No/Date:7/82- ALC4/20I5 24.07.2015 Lic.No/Date;09I006III4 17.10.2014 Status:Case Approved Defer Date: Decision : The committee decided to ratify the norms based on the recommendation of Department of Pharmaceuticals vide letter No.35011/ 317/2014-PI (Norms) dt. December 2014 as per details given below or as applied by the firm whichever is less:- Export product Import items Qty.allowed Imatinib lOOmg tablet Imatinib Mesylate I2I.858mg/100 mg tablet Imatinib 400mg tablet Imatinib Mesylate 487.43 lmg/400 mg tablet RA may take further action accordingly.

n F.NO.35011/860/2015-PI (Norms) Government of India Dated; j'^-October, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s Aurobindo Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1319/AM-16/DES- 3/1821 dated the 15/3/2016 vide which application from M/s Aurobindo Pharma Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Amoxicillin and Clavulanate Pot. Oral Suspension 156.25mg/5ml and 312.50mg/5ml. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S.No. Import item Norms Recommended for I No., 100ml Bottle 156.25mg/5ml 312.50mg/5ml 1 6-APA 1628.50mg 3256.91 mg 2 D(-)para hydroxyl phenyl glycine base 1343.76mq 2687.53mg 3 Methyl acetoacetate 1022.95mg 2045.89mg 4 Methanol 837.74mg 1675.47mp 5 Triethylamine 83.14mg 166.29mg 6 Methylene chloride 946.11mg 1892.22mg 7 Isopropyl alcohol 1207.00mg 2414.01mg 8 N,N-dimethyl acetamide 283.83mg 567.67mg 9 PivaloyI chloride 946.11mg 1892.22mg 10 Clavulanate Potassium + Avicel / Pot. Clavulanate diluted with microcrptelline cellulose (1:1) (in active base) 1550.65mg 3101.30mg 2. (Rajkumar) PH:-23071162

u 1 F. NO.35011/853/2015-PI (Norms) Government of India Office Memorandum Shastrl Bhawan, New Delhi Dated: Septembers, 2016 Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol i) 2009-14 Appiication of M/s Curetech Sklncare. The undersigned Is directed to refer to DGFT U.O. No. 01/82/050/01574/AM- 16/DES-3/1699 dated the 19.02.2016 vide which an appiication from M/s Curetech Skincare. was forwarded to this Department for fixation of norms for the export of Bacitracin Neomycin Sulphate Ointment 15 gm tubes. This department has examined the matter and the foliowing norms are furnished: - Export Item Quantity Import Item Quantity allowed for 100 tubes Bacitracin Neomycin Sulphate Ointment 15 gm tubes (each gm conlain 500 iU Bacitracin Zinc and Neomycin Suiphate) 100 tubes Bacitracin Zinc USP 19.125 gm 2. This issues with the approvai of competent authority. (Ra Kumar) of India Under Secretary to the Governmen Phone:23071162 Emaii: uspi3-pharma@nlc.in Directorate Generai of Foreign Trade, (SaMl.lV Singh, FTDO). Udycg Lhawan, New Delhi-110011.

A/g . / Case No.:2()6/6/82- ALC4/2014 HQ File i;OI/82/050/00608/AMI5/ Parly Name:HPL ADDITIVES iLIM[TED(FORMERLY iKNOWN HIGH POLYMER 'iRLATile i:05/23/040/00092/AM]5/ ;Meel No/Dalc:9/82- iALC4/20[4 20.10.2014 Status: Approved Lic.No/Daic;0510389362 iDefer Dale: 04.07.2014 i Decision : In the light of written comments received from Department of Chemicals and I Petrochemicals vide their U.O No. 14010/7/2011-Ch II dated 17.09.2014, it was decided 388 to ratify norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. SI.No, Import items Qty. allowed 1,3 Dtbromo 5.5 Dimethyl Hydantoin I kg 1. Acetone Cyanohydrin 0.437 kg 2. Ammonium Bicarbonate 0,436 kg 3. Liquid Bromine 0.680 kg ■RA may take appropriate action as per the decision of Norms Committee.

Case No.!58/14/82-ALC4/2012 Party Name:BALAJI AMINES LIMITED HQ File ;01/82/050/00435/AM13/ RLA File :31/83/040/00073/AM13/ MeetNo/Date:24/82^ Al]f4/2012 15111.2012 Lic.'No/Date:3110055046 19:07.2012 StatusrCase Approved Defer Date: 209 Decision : In the light of written comments received from Department oj'jphernicals and Petrochemicals,vide their U.O No. 14010/85/2008-Ch. II dated 14.9.2009, n >vas decided to A ac npr HptnilR oiven below or as appliea by the lirm. ratify norms under Para 4.7 of HBP vl as per details given whichever is less: I I Export Product N-Methyl-2-Pyrroiidone Export Qty. .1 kg SLNo. 1. 2. Import items Methanol Gartima Butyrolactone 3. Ammonia \ RA may take appropriate action aj^per the deci^on';Of_Norms Ccmpittee. _ Qty. allowed kg/kg. 0.377 0.965 h I I '

Case No.:211/3/82- ALC4/20I4 HQFile :01/82/05()/00215/AM15/ Party Name:DEEPAlC NITRITE LIMITED RLA File ;34/24/040/0020I/AMI4/ Meet No/Date:8/82- ALC4/2014 25.09.2014 Uc.No/Date:34100392I9l ||_ _ Status:Case Approved Defer Date: 79 Decision : In the light of written comments received from Department of Chemicals' and Petrochemicals vide their U.O No. 14010/36/2012-Ch. ll dated ,2'8.07.20l|, it was decided to ratify norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less: Export product 3.4 NITRO ORTHO XYLENE (4 NOX) Exp. Qty. 1kg 5i.No. import Items ORTHO XYLENE RA may,take'appropriate action as per the decision of Norms Committee. Qty. Allowed 1.63 kg h' I I- li: ,1 l i !'' , 'I • li," a I 1 1 1^} ll' I'f. ' ■'!
' 1,'. 1

f -2, F.NO.35011/217/2016-PI (Norms) Government of India Dated:^ I October, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of WI/s Arene Lifesciences Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1462/AM- 16/DES-3/324 dated the 12/7/2016 vide which application from M/s Arene Lifesciences Ltd. was sent to this Department for fixation of norms underpara: 4.7 for the export of Saquinavir Wlesylate. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- DGFT may therefore be advised the firm to give complete technical details as per Appendix-33. 2. (Rajkumar) PH:-23071162

258 Case No.:l/49/82-ALC4/20n Party Name;UNITED PHOSPHORUS LTD. Meet No/Date:6/82- ALC4/2012 08.05.2012 Status:Case Approved HQ File :01/82/050/01310/AM12/ RLA File :03/95/040/00809/AM12/ Lic.No/Date:0310682983 22.02.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 15022/2/2012-Ch. II dated 8.5.2012, it was decided to ratify norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less: Export Product Export Quantity S.No Import Product Quantity Allowed Phenyl Chloroformate 1 kg 1. Phenol 0.666 kfi 2. Ethylene Dichloride 0.292 kg

/- z. F.NO.35011/218/2016-PI (Norms) Government of India Datedio?! October, 2016 Office Memorandum Subject. - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14 Case of WI/s Alkaloids Corporation. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/37/AM-17/DES- 3/327 dated the12/7/2016 vide which application from M/s Alkaloids Corporation, 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 furnished under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14:- DGFT is advised to call from the firm COA of the imported digitalis leaves from the foreign supplier. 2. (Rajkumar) PH:-23071162 (Shri M.V. Singh. FTDO),

F. NO.35011/47/2016-PI (Norms) Government of India Shastri Bhawan, New Delhi, the September 8, 2016 Office Memorandum Subject; - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s Amol Pharmaceuticals (P) Ltd. The undersigned is directed to refer to DGFT U.O. Nos. 01/82/050/01741/AM-16/DES- 3/1903 dated the 30.03.2016 vide which application from M/s Amol Pharmaceuticals (P) Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of AZO Urinary Tract Defense. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14: - • s No. Export Item Quantity Import Item Quantity allowed for 1000 tablets 1. AZO Urinary Tract Defense (each tablet containing 162 mg Methenamine) 1000 tablets Methenamine 163.6 gm 2. This issues with the approval of competent authority (Raj Kumar) Phone: -23071162 Email: uspi3-pharma@nic.in Department of Commerce.

A 1 z ■2^X0 Case No.:39/9/82-ALC4/2014 Party NameiSHREE BANKEY BEHARI LAL AROMATICS Meet No/Date: 11/82- ALC4/20I4 26.11.2014 Status: Approved HQ File ;01/82/050/00836/AM15/ RLA File :05/24/040/00192/AM15/ Lic.No/Date;0510390613 20.08.2014 Defer Date: 357 Decision : in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/28/2012/Ch II dated 28.07.2014, it was decided to ratify norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less: Export Product Export Quantity S.No Import Product Quantity Allowed L-CARVONE 1 kg 1 D-LIMONENE (LIMONENE CITRUS TERPENE, ORANGE TERPENE, BRAZILIAN CITRUS TERPENE, STANDARD CITRUS TERPENE, ORANGE OIL), 2.50 kg RA may take appropriate action as per the decision of Norms Committee

'5: ziz F.NO.35011/848/2015-PI (Norms) Government of India Dated: I30ctober, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of Wl/s Styrax Pharma Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/151/AM-17/DES-3/553 dated the 7/9/2016 vide which representation received from M/s Styrax Pharma Pvt. Ltd.^ was sent to this Department for revision of norms under para: 4.7 for the export of 4-Amini-5- Fluoro-1-[(2R,5S)-2-HydroxymenthylO-1,2-Oxathaiolan-5yl] Pyrimidin-2(1H)-0ne (EWIO-I). This department has examined the matter in line with copy of US and EU patents and Central Excise Certificate furnished now by the applicant, and the following revised norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S.No. Import item Norms Recommended for 1kg Export 1 FCE 2.075kq 2 Dipotassium hydrogen ortho phosphate 1.90kq 3 Sodium borohydride 0.46kg 4 Ortho phosphoric acid 0.45kg 5 Isopropvl alcohol 2.72kq 6 Toluene 0.59kq 2. (Rajkumar) PH:- 23071162

./ 1-^ F. No.35011/173/2016-Pi -Norms Government of India Shastri Bhawan, New Delhi, the September 26, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s Aurobindo Pharma Ltd. The undersigned is directed to refer to DGFT U.O. No. 01/82/50/1576/AM-16/DES- 3/244 dated the 08/07/2016 vide which application from M/s Aurobindo Pharma Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Penicillin V Potassium 500 mg Tablets and 250 mg Tablets. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14:- S. No Import Item Norms Recommended 500 mg 250 mg 1. Phenoxymethyl Penicillin Potassium (Penicillin V Potassium) 565.5mg/500mg Tablet 282.75mg/250mg Tablet 2) This issues with the approval of competent authority. (Raj Kumar) Phone:-23071162 Email: uspi3-pharma@nic.in Directorate General of Foreign Trade. Udyog Bhawan, New Delhi-110011

// iCas>NoT:647l5/82-ALC4/20I4 jParty Name:HPL ADDIT^IVES |LIMITED(FORMERLY : IKNOWN HIGH POLYMER Meet No/Date:4/82- ALC4/2015 12.06.2015 'HQ File ';01/82/050/0135[/AMI5/ RLA File :05/23/040/00305/AM15/ :Lic.No/Date:05]039!738 127.10.2014 Approved jDecision :The committee decided to ratify the norms based on the recommendation of Department of C&PC vide U.O.No.l4010/7/2011-Ch-ll dt. 29.5.2015 as per details given below or as applied by the firm whichever is lower:- Export product Qty Import items Qty Azodicarbonamide Ikg Hydrazine Hydrate(100%) 0.548 kg Technical Grade Urea 1.316kg RA may take further action accordingly.

Case No,:5/40/82-ALC4/20U Party Name:DEEPAK NITRITE LIMITED Meet No/Date:44/82- ALC4/20II 31.01.2012 Status:Case Approved HQ File :01/82/050/01001/AM12/ RLA File :31/83/040/00174/AM12/ Lic.No/Date:3110052057 22.12.2011 Defer Date: 222 Decision : Committee considered case as per agenda and in lignt ot written aecision laKen m meeting no 28/82 held on 11.10.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Exp. Qty. SI.No. Import items Qtv. allowed 0.765 kg 2-Ethyl Hexyl Nitrate 1 Kg. 1. I 2-Ethvl Hexanol RA concerned may take further necessary action as per above decision of NO.

z_ F. No.35011/705/20I3-PI (Norms) Government of India Ministry of Chemical & Fertilizers New Delhi, the Udyog Bhawan, February, 2015 Office Memorandum Sub; Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s. Wanbury Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/494/AM15/DES-3/602 dated the 08/09/14 vide which an application from M/s. Wanbury Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Mefenamic Acid. This department has examined the matter and the following comments are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S. No. Import Item Qty. Recommended kg/kg. Orthochloro Benzoic Acid 1.053 Or—2;3^ylidTne ■0v806— Isopropyl Alcohol 1.763 4. ^thanch^ Not shown in process. Note:- DGFT may call All Industry Production-Consumption data through Pharmexil duly certified by Central Excise Authorities for revision of SIGN A-286 for Mefenamic Acid. 2. This issues with the approval of Director (PI). (Bamali Khastgir) Phone-23071162

F. NO.35011/102/2016-PI (Norms) Government of India Udyog Bhawan, Ne\A/ Delhi, Dated; August, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.I) 2009-14 Case of Afl/s Strides Shasun Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/131/AM-17/DES- 3/96 dated the 23/5/16 vide which application from M/s Strides Shasun Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Nystatin Tablets 500000 units (86.99mg). This department has examined the matter and the following norms are furnished under para 4.7 of Fland Book of Procedures (Vol.1) 2009-14:- S.No. Import item Norms Recommended 1 Nystatin USP 88.73mg/tablets 2. (Rajkumar) PH:- 23071162 (ShriM.V. Singh, FTDO),

V o F. No.35011/87/2016-Pi (Norms) Government of India 1% Dated: ^ September, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s Rusan Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/29/AM-17/DES- 3/58 dated the 5/5/16 vide which application from M/s Rusan Pharma Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Nalbuphine Hcl. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S.No. Import item Norms Recommended for 1kg Export 1 Thebaine 2.117kg 2 Lithium-aluminium hydride pellets 0.424kg 2. (Rajkumar) PH:- 23071162 (ShriM.V. Singh. FTDO),

% G F.NO.35011/216/2016-PI (Norms) Government of India Udyog Bha\A/an. New Delhi. Dated:^ ( October. 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.1) 2009-14 Case of M/s Saurav Chemicals Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/362/AM-17/DES- 3/432 dated the 19/8/2016 vide which application from M/s Saurav Chemicals Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of ILC (1S,4S,5S)-4-lodo-6-Oxabicyclo[3.2.1] Octan-7-One. This department has examined the matter and the following norms are furnished under para 4.7 of Fland Book of Procedures (Vol.1) 2009-14:- S.No. Import item Norms Recommended for 1kg Export 1 3-cyclohexene-1-carboxylic acid 3.00kg 2 R-(+)-1-phenyl ethyl amine 2.50kg 3 Iodine 1.18kg 4 Potassium iodide 0.35kg 5 Ethyl acetate 4.32kg 2. (Rajkumar) PH:- 23071162 Directorate General of Foreign Trade. Department of Commerce. (Shri M.V. Singh, FTDO).

F. NO.35011/5/2016-PI (Norms) Government of India ^' a Udyog Bhawan, Nev/ Delhi, Dated; 6 June, 2016 Office Memorandum Subject; - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.I) 2009- 14 Case of M/s Wlylan Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1754/AM- 16/DES-3/1896 dated the 30/3/16 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 Emtricitabine. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14;- S.No. Import item Norms Recommended for 1kg Export 1 (2R.5S)-5-(4-amino-5-fluoro-2-oxo-2H-pyrimidin-1-yl)- [1,3]oxathiolane-2-carboxylic acid-2S-isopropyl-5R- methyl-IR-cyclohexyl ester (FCE) 2.50kg 2 Dipotassium hydrogen orthophosphate 2.07kg 3 Sodium borohydride 0.50kg 4 Triethylamine 1.10kg 5 Isopropyl alcohol 2.11kg 6 Methanol 0.33kg 7 Methylene dichloride 1.71kg 8 Toluene 0.16kg 9 Activated carbon 0.100kg 2. (Rajkumar) PH;-23071162 F. NO.35011/8/2016-PI (Norms) Government of India

X7 6 :Case No.:99/3/82-ALC4/2014 iParty Nanic:AV^ 'CHEMICALS PVT.LTD,. HO File :OI/82/O5O/0OI03/AM15/ RLA File :03/94/040/00952/AM14/ Meei No/Daie:3/82- Stalus:Case ALC4/2014 Approved 08.05.2014 Lic,No/Date;0310769004 'Defer Date: 04,02,2014 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/157/2011-Ch. II dated 29.05.2014, it was decided to ' 'ratify norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, I :whichever is less: Export product Export Quantity S.No. Import items Quantity Allowed DISODIUM MANGANESE EDTA (Manganese Content 12,5% -*-/• 0,5) 1 kg 1 Elhylene Dlamine Tetra Acetic Acid 0.690 kg

F. NO.35011/186/2016-PI (Norms) Government of India Dated: | o August, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s Fresenius Kabi Oncology Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/282/AM-17/DES- 3/273 dated the 8/7/16 vide which application from M/s Fresenius Kabi Oncology Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Oxaliplatin injections 200mg/40ml, 100mg/20ml and SOmg/IOml. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14;- S.No. Import item For the export of 1 No. injection (Qty. in gm) 200mg/40ml 100mg/20ml 50mg/10ml 1 Platinum (sponge powder) 0.184 0.0919 0.046 2 (1R,2R)-(-)-1,2- Diamino cyclohexane 0.1029 0.0515 0.0257 3 Glass vials Relevant, As per packing policy 4 Rubber stoppers 2.

1 I 0 (Rajklimar) PH:- 23071162 (ShriM.V. Singh, FTDO),

I "2. Case No.:84/10/82-ALC4/2013 HQ File ;0I/82/050/00267/AM14/ Party Name:RA CHEM PHARMA LIMITED RLA File :09/24/040/006I7/AM13/ Meet No/Date: 10/82- ALC4/2013 22.08.2013 Lic.No/Date:0910055631 28.03.2013 Status:Case Approved Defer Date: Decision : In the light of earlier decision taken in meeting no. 24/82 dated 14.9.2010, it was decided to ratify norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less: 238 Export product Exp. Qty. Sl.No. Import items Qty. allowed Ethyl Methoxy Crylene I kg 1. 4-methoxy Benzophenone 0767kg 2 Ethyl Cyano Acetate 0.409 kg 3 Toulene 0.500kg 4 Methanol 0.400 kg

(■- iCase No.:l69/3/82- iALC4/2014 HQ File :01/82/050/00!73/AMI5/ Party Name:BENZO CHEM IMeet No/Datc:3/82- INDUSTRIES PRIVATE iALC4/20]4 LIMITED. i08.05,20l4 StatusrCase Approved iRLA File ::()3/94/040/00868/AMI4/ Lic.No/Date;()3l0767ll 8 21,01.2014 Defer Date: Decision :Committee considered case as per agenda and in light of written comments, forwarded by Deptt of C&PC vide their U.O.No. 14010/29/2011-Ch.ll dated 29.05.2014 and in consultation with the technicai authorities present in the meeting decided to ratify norms under: para 4.7 of HBP as per details below or as applied by firm whichever is iower:- 27 0 Export product Exp. Qty. SI.No. Import items Qty. allowed 2,5-Dimethyi Phenyi Acetyl Chloride 1 kg 1. Para Xylene 1.485 kg 2. Paraformaldehyde 1,032 kg 3. Sodium Cyanide 0.570 kg 4, Caustic Soda Flakes 0,500 kg 5. Thionyl Chloride 0.980 kg i RA concerned may take further necessary action as per above decision of NC

F.NO.35011/260/2016-PI (Norms) Government of India Office Memorandum D Dated; September, 2016 Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14 Case of Wl/s Aurobindo Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/260/AM-16/DES-3/455 dated the 23/8/2016 vide which application from M/s Aurobindo Pharma Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Clopidogrel Bisulfate . This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S.No, Import item Norms Recommended for 1kg Export 1 4,5,6,7-Tetra hydrothieno [3.2-Cl pyridlne Hcl OR cvclic amine hcl 0.862kg 2 (1 R)-(-)-(10)-camphor sulfonic acid 0.70kg 3 Activated carbon 0.039kg 4 Potassium carbonate anhydrous 0.417kg 5 Triethvlamine 1.241 kg 6 Acetone 5.80kg 7 Methanol 1.64kg 8 Methvlene chloride 1.54kq 9 Toluene 0.86kg 2. (Rajkumar) PH:-23071162 (Shh M.V. Singh, FTDO),

J3/ Jo ^ iCase No.:6/l I/82-ALC4/2012 |Party Name:AVIGNON EXIM ' iPVT.LTD.. Meet No/Date; 16/82- ALC4/2012 16.08.2012 fHQ File |:OI/82/050/00273/AM13/ RLA File :03/94/040/00021/AMI3/ Lic.No/Date:0310692165 25.04.2012 StatusrCase Approved Defer Date; '225 Decision : In the light of written comments received from^^rtment of Chemicals and Petrochemicals vide their U.O No. l4010//2009-Ch. 11 dated 23.7.2012, it was decided to ratify norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, iwhichever is less: Export product Exp. Qty. SI.No. Import items Qty. allowed 3,5 Lutidine 1 kg 1. Crude 3.5 Lutidine 1.368 kg may take appropriate action as per the decision of Norms Committee.

F.NO.35011/210/2016-PI (Norms) Government of India Udyog Bhawan, Ne\A/ Delhi, Dated: September, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.!) 2009-14 Case of WI/s Wletrochem API Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/511/AM-17/DES-3/384 dated the 17/8/2016 vide which application from M/s Metrochem API Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Saxagliptin FIci. This department has examined the matter and the following norms are furnished under para 4.7 of Fland Book of Procedures (Vol.1) 2009-14:- S.No. Import item Norms Recommended for 1kq Export 1 BOC-3-hydroxy-1-adamantyl-D-glycine 2.64kq 2 (1S,3S,5S)-2-azabicyclo-(3,1,0)hexane-3~ carboxamide mesylate 1.80kg 2. (Rajkumar) PH:-23071162 Directorate General of Foreign Trade.

2 zn F. NO.35011/103/2016-PI (Norms) Government of India Dated: August, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14 Case of Wl/s Strides Shasun Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/128/AM-17/DES- 3/110 dated the 23/5/16 vide which application from M/s Strides Shasun Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Mirtazapine Tablets USP 15mg. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S.No. Import item Norms Recommended 1 Mirtazapine USP 15.3mg/15mg tablets And 30.6mg/30mg tablets 2. (Rajkumar) PH:- 23071162

Ji F.NO.35011/213/2016-P1 (Norms) Government of India Dated: ^^October, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.1) 2009-14 -Case of IVI/s Glenmark Pharmaceuticals Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/351/AM-17/DES- 3/340 dated the 17/8/2016 vide which application from M/s Glenmark Pharmaceuticals Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Adacne Clin Gel 45gm. This department has examined the matter and the following norms are furnished under para 4.7 of Fland Book of Procedures (Vol.1) 2009-14:- S.No. Import item Norms Recommended 1 Clindamycin Phosphate 546.21mg/45gm pack 2. (Rajkumar) PH:- 23071162 Department of Commerce.

(L..^; / F.No.35011/214/2016-PI (Norms) Government of India Dated: 30 / 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14 Case of Wl/s Virupaksha Organics Ltd. The undersigned is directed to refer to DGFT U.O. No. 01/82/050/00487/AM- 17/DES-3/389 dated the 17/08/2016 vide which application from M/s Virupaksha Organics Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Daclatasvir Dihydrochloride. This department has examined matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14:- S.No. Import item Norms Recommended for 1kg Export 1 4,4-Bis(2-((S)-Pyrrolidin-2-yl)-1H-imidazol- 5yl)-1,1-biphenyl hydrochloride 0.70 kg 2 Moc-L-Valine 0.55 kg 3 N-(3-DimethylAminopropyl)-N- Ethylcarbodiimide FIcI 0.60 kg 2. (F^ajkumar) PH:- 23071162

/ X 7 2.27 F. NO.35011/42/2016-PI (Norms) Government of India ■Ministry of Chemioal & Fertilizers Dated: August, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.i) 2009-14 Case of IVI/s Satyadeva Pharmaceuticals (P) Ltd. 3/188/d^ted to referto DGFT U^, 01/82/50/1764/AM-16/DES- 3/ 881 dated the 22/3/16 vide which application from M/s Satyadeva Pharmaceuticals MR Department for fixation of norms under para: 4 7 for the export of This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14;- ■ S.No. Import item Norms Recommended for Ikq Export 1 (4R-Cis)-1,1 -dimethyiethyl-6-cyanomethyl-2,2- dimethyl-l ,3-dioxane-4-acetate 1.01kg 2. (Rajkumar) PH:-23071162

F. NO.35011/43/2015-PI (Norms) Government of India Ministry of Chemicals & Fertilizers 7^ Udyog Bhawan,New Delhi, Dated the June, 2015 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s MaithfH^ab^Vt Ltd. The undersigned is directed to refer to DGFT U.O.No. 0I/82/50/1091/AM-15/DES- 3/1001 dated the 06/01/15 vide which application from M/s. Maithri Labs Pvt Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of (4R-CIS)-l,l-DimethyI ethyl-6-(2-amino ethyI)-2,2,DimethyI-l,3-Dioxane-4-acetate (amino ketal). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S.No. Import Item Qty. Recommended kg/kg. 1. (4R-CIS)-l,l-Dimethylethyl-6-Cyano methyl- 2,2,Dimethyl 1,3-Dioxane -4-acetate 1.079 2. This issues with the approval of Director (PI). (Bamali Khastgir) Phone:23071162

7 1- 2^ F.NO.35011/211/2016-PI (Norms) Government of India Dated; September, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14 Case of Wl/s Hetero Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/61/AM-17/DES-3/373 dated the 17/8/2016 vide which application from M/s Hetero Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Budesonide. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14:- S.No. Import item Norms Recommended for 1kg Export 1 2-oso-2-{(8s,9s,10R,11s,13s,16R.17s)- 11,16,17-trihydroxy-10,13-dimethyl-3-oxo- 6,7,8,9,10,11,12,13,14,15,16,17- dodecahydro-3H-cyclopenta [a] - phenanthren-17-yll ethyl acetate 1.84kg 2. (Rajkumar) PH:-23071162 (Shri M.V. Singh. FTDO),

F.NO.35011/211/2016-PI (Norms) Government of India Dated: September, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of IVI/s Hetero Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/62/AM-17/DES-3/405 dated the 17/8/2016 vide which application from M/s Hetero Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Levetiracetam. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S.No. Import item Norms Recommended for 1kg Export 1 (Alpha S)-alpha-ethyl-2-oxo-1 -pyrrolidine acetic acid 1.40kg 2 Ethyl chloroformate 1.06kg 3 Acetone 1.373kg 2. (Rajkumar) PH:-23071162

L F. NO.35011/201/2016-PI (Norms) Government of India % Dated: \ 0 August, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of IVI/s Morepen Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/205/AM-17/DES- 3/290 dated the 11/7/16 vide which application from M/s Morepen Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Rosuvastatin Calcium. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S.No. Import item Norms Recommended for 1kg Export 1 Tert-butyl-2-((4R,6S)-6-{(E)-2-(4-(4-fluoro phenyl) -6-isopropyl-2-[N-methyl (methyl sulfonyl) amino] pyrimidin-5-yl) vinyl) -2,2- dimethyl-1,3-dioxane-4-yl) acetate 1.425kg 2 Methanol 2.53kg 3 Tert-butyl methyl ether 0.79kg 2. . jO-'ti-li (Rajkumar) PH:- 23071162 (ShriM.V. Singh, FTDO),

t F.NO.35011/260/2016-PI (Norms) Government of India Dated: September, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14 Case of M/s Aurobindo Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/464/AM-17/DES-3/484 dated the 24/8/2016 vide which application from M/s Aurobindo Pharma Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Benazepril Hcl. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S.No. Import item • Norms Recommended for 1kg Export 1 (RV2-hvdroxv-4-phenvl butanoic acid ethvl ester 0.684kg 2 Activated carbon 0.033kq 3 Hexanes 2.416kg 4 Potassium carbonate (Anhy.) 0.127kg 5 Tert Butvl /SH3-amino caoroiactam 0.808kg 6 Toluene 2.196kg 7 Triethylamine 0.48kq 2. (Ra kumar) PH:-23071162

33 i iLIMITED iMeet No/Date: 10/82- StatusrCase ULC4/2013 Approved ,22.08.2013 HQ File ;OI/82/050/00247/AM14/ RLA File :31/83/040/0021 I/AM 13/ Lic.No/Date;31 10057826 05.04.2013 Defer Date: 262 Decision : In the light of written comments received from Department of Chemicals and Petrochemic^ vide their U.O No. 140l0/122/20l l-Ch. 11 dated 12.4.2013, It was decided to ratify norms under Para 4.7 ofl HBP vl as per details given below or as applied by the firm, whichever is less: Export product Exp. SI.No. Import items Qty. allowed Qty. N-Methyl-2-Pyn'olidone 1 kg 1 Methanol 0.370 kg 2. Ammonia Anhydrous 0.160 kg 3. 1,4 Butanediol 1.044 kg 4. Methylamine 0.00080 kg 5. GBL Catalyst 0.00075 kg |RA may take appropriate action as per the decision of Norms Committee

A 5 F. NO.35011/201/2016-PI (Norms) Government of India V Dated: f i? August, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s Wlorepen Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/221/AM-17/DES- 3/302 dated the 13/7/16 vide which application from M/s Morepen Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Atorvastatin Calcium. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S.No. Import item Norms Recommended for 1kg Export 1 (4R-cis)-1,1 -dimethyl ethyl-6-cyanomethyl-2,2- dimethyl-1,3-dioxane-4-acetate 0.708kg 2 4-fluoro-alpha-[2-methyl-1-oxopropyl]-gamma- oxo-N-beta-diphenyl benzene butanamide 0.994kg 3 Methanol 4.285kg 4 Methyl tert-butyl ether 1.145kg 5 Tetrahydrofuran 0.542kg 6 Methylene chloride 1.414kg 7 Diisopropyl ether 0.754kg 2. (Rajkifhar) PH:- 23071162

0

2 9-r- Case No.:6(/6/82-ALC4/20I4 !HQ File !:OI/82/050/00463/AM15/ iParly Name:ATLAS FINE iCHEMICALS PVT LTD |RLA File :03/94/040/00838/AM14/ iMeet No/Date:6/82- Status: :ALC4/20I4 Approved :29.08.2()14 iLic.No/Date:03 lb?'?! 877 'Defer Dale? ;25.02.20[4 I ^Decision ; In the light of written comments received from Department of Chemicals and jPetrochemicals vide their U.O No. 14010/74/2013-Ch II dated 17.01.2014, it was decided to ratify .norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever Is Jess: Export product Exp. Qty. SI.No. Import items Qty. allowed COUMARIN Apperaiice; Cr)'Staline Powder Freezing Point: 68C Minimum Mollen Apperance; Clear Odor: Standard Assay: 99% Minimum Color of Sulphuric and Solution: 125 Hazen Maximum Molecular Weight: 146 Boiling Point: 3 IOC 1 kg 1. Salicylaldehyde MolecuiarWeight: 122.12 2 Hydroxybenzaldehyde Specifications: Appearance Straw colour Liquid Colour: 200Hazen Maximum Assay (GLC 95-99% Minimum Water Content 0.5% Maximum 0.920 kg :84 iA may take appropriate action as per the decision of Norms Committee.

5k . jsr-:}- 319 jCasc No.:38/28/82-ALC4/2012 i Party Name:DEEPAI< NITRITE LIMITED Meet No/Date:28/82- ALC4/20I2 10.01.2013 Status:Case Approved IHQ File i:0l/82/05O/01005/AM]3/ RLA File :34/24/040/00064/AMI3/ Lic.No/Date:3410035377 31.10.2012 Defer Date: Decision : In the light of earlier decision taken decided to ratify norms under Para 4.7 of HBP the firm, whichever is less: in meeting no. 44/82 dated 31.1.2012, it was vl as per details given below or as applied by Export product Exp. Qty. SI.No. Import items Qty. allowed 2-Ethyl Hexyi Nitrate 1 Kg. 1. 2-Ethyl Hexanol 0.765 kg

/ i F.NO.35011/210/2016-PI (Norms) Government of India Dated: September, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.I) 2009- 14 Case of Mis Metrochem API Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/482/AM- 17/DES-3/382 dated the 17/8/2016 vide which application from M/s Metrochem API Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Clopidogrel Bisulphate. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.I) 2009-14:- S.No. Import item Norms Recommended for 1kg Export 1 DL-2-chloro phenyl glycine 1.00kg 2 Thiophene-2-Ethanol 0.60kg 2. (Rajkumar) PH:- 23071162 (ShriM.V. Singh, FTDO),

t 3>-75 F.NO.35011/230/2016-PI (Norms) Government of India Udyog Bhawan, Nev/ Delhi, Dated: September, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s Aurobindo Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/506/AM-17/DES-3/356 dated the 17/8/2016 vide v/hich application from M/s Aurobindo Pharma Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Cefprozil Monohydrate (Cefprozil) . This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S.No. Import item Norms Recommended for 1kg Export 1 7-PACA OR [f6R,7R)-7-amino-3-cephem-4-carboxvlic acid] 0.77kg 2 Activated carbon 0.0386kg 3 Ethyl chloro formate 0.383kg 4 Hexa methyl disilazane 0.342kg 5 Imidazole 0.004kg 6 Thmethyl chlorosilane 0.230kq 7 Acetone 4.40kg 8 Dimethyl formamide 3.74kg 9 Methylene chloride 4.02kg 10 Methanol 1.83kg 11 D(-)para hydroxyl phenyl glycine base 0.598kg 12 Methyl acetoacetate 0.443kg 13 Potassium carbonate 0.242kq 2. X (Rajkumar) PH;- 23071162

s F.NO.35011/209/2016-PI (Norms) Government of India Office Memorandum Udyog Bhav^an, New Delhi, Dated: September, 2016 Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.!) 2009-14 Case of M/s Divi's Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/501/AM-17/DES-3/338 dated the 17/8/2016 vide which application from M/s Divi's Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Valacyclovir Hcl. This department has examined the matter and the following norms are furnished under para 4,7 of Fland Book of Procedures (Vol.1) 2009-14:- S.No. Import item Norms Recommended for Ikq Export 1 Acyclovir 0.758kq 2 N,N-Dicyclo Flexyl carbodiimide 1.061kg 3 Formic acid 94% O.ISkq 4 Dimethyl formamide I.eOkq 5 Acetone 5.90kg 6 Z-L-Valine 1.1824kg 7 Palladium metal 0.0005kg 2. (Rajkumar) PH:-23071162

F. NO.35011/171/2016-PI -Norms Government of India t L O r- New Delhi, the Shastri Bhawan, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009- 14 Case of M/s Fresenius Kabi Oncology Ltd. The undersigned is directed to refer to DGFT U.O. No. 01/82/050/00228/AM- 17/DES-3/276 dated the 08/07/2016 vide which application from M/s Fresenius Kabi Oncology Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Cytarabine Injections 2gm and 1gm. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14: - S. No Import Item For Export of 1 No. Injection 1 gm/10 ml 2gm/ 20 ml 1. Cytarabine Ph Eur/USP/IP 1.10 gm 2.10 gm 2. Glass Vials Relevant, As per Packing Policy 3. Rubber Stoppers 2) This issues with the approval of competent authority. (Raj Kumar) Phone: -23071162 Email: uspi3-pharma@nic.in Udyog Bhawan, New Delhi-110011

t F.NO.35011/237/2016-PI (Norms) Government of India Dated: I^October, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Fiand Book of Procedures (Vol.1) 2009-14 -Case of M/s Supriya Life Sciences Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/388/AM-17/DES- 3/434 dated the 19/8/2016 vide which application from M/s Supriya Life Sciences Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Ractopamine Hcl. This department has examined the matter and the following norms are furnished under para 4.7 of Fland Book of Procedures (Vol.1) 2009-14:- S.No. Import item Norms Recommended for Ikq Export 1 Octopamine FIcI 0.833kg 2 Raspberry Ketone 0.70kg 3 Palladium on Charcoal 5% 0.015kg 2. (Rajkumar) PH:- 23071162

t L / "2- F.NO.35011/253/2016-PI (Norms) Government of India Dated: ^October, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Fiand Book of Procedures (Vol.1) 2009-14 Case of Wl/s IVlorepen Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/441/AM-17/DES- 3/492 dated the 24/8/2016 vide which application from M/s Morepen Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Atorvastatin Calcium. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S.No. Import item Norms Recommended for 1kg Export 1 4-fluoro-alpha-[2-methyl-1-oxopropyl]-gamma-oxo- N-beta-diphenyl benzene butanamide 0.994kg 2 (4R-Cis)-1,1-dimethylethyl-6-cyanomethyl-2,2- dimethyl-1,3-dioxane-4-acetate 0.708kg 3 Methylene chloride 4.35kg 4 Diisopropyl ether 3.79kg 2. (RajJjmar) PH:-23071162 Directorate General of Foreign Trade.

F. No.35011/57/2016-P( (Norms) Government of India 7. Udyog Bhavi/an, New Delhi, Dated; August, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14 Case of IW/s Sun Pharma India Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1677/AM-16/DES- 3/1796 dated the 4/3/16 vide which application from M/s Sun Pharma India Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export ofVolIni Gel 30gm. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.I) 2009-14:- S.No. Import item Norms Recommended 1 1 Racementhol 1.53gm/30gm tube 2. This issues''with the approval of p6tripetent-.authority. (Rajk'Lifffar) PH:-23071162

n \z 3^3 Case No.:211/33/82- ALC4/2012 HQ File ;0!.'S2/050/0l358/AM13' Pam' Name:0 C SPECIALITIES PVT.LTO. RLA Fiie ;03/95/040/00841/AM13/ Meet No/Date:33/82- ALC4/2012 21.03.2013 Lic.No/bate:0310722151 28,01.2013 Statu5:Case Approved Defer Date; Decision -In the li^hl of written comments received from Depanment ofChemmals and Petrochemicals viSe .he,r U.O No. 140.0^08/2012-Ch II dated bv the firm, whichever Export Product is less; Export Quantity S.No Import Product Quantity allowed 23-Dichloro Pyridine 1 kg ifp nr.tinn as r 1. er the di. 3 Amino Pyridine 'cision of Norms Committt 1.44 kg e.

12- Case No.:84/10/82-ALC4/2013 HQ File :01/82/050/00267/AMI4/ Party Name:RA CHEM PHARMA LIMITED RLA File :09/24/040/00617/AM13/ Meet No/Date: 10/82- ALC4/2013 22.08.2013 Lic.No/Date:0910055631 28.03.2013 Status:Ca$e Approved Defer Date: Decision : In the light of earlier decision taken in meeting no. 24/82 dated 14.9.2010, it was decided to ratify norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. SI.No. Import items Qty. allowed Ethyl Methoxy Crylene 1 kg 1. 4-methoxy Benzophenone 0767kg 2 Ethyl Cyano Acetate 0.409 kg 3 Toulene 0.500kg 4 Methanol 0.400 kg 238

I '2_- '597- F.NO.35011/270/2016-PI (Norms) Government of India Dated:^! October. 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of IW/s Granules India Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/452 & 594/AM- 17/DES-3/497 & 549 dated the 24/8/2016 & 6/9/2016 vide which application from M/s Granules India Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Ledipasvir Acetone Solvate. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S.No. Import item Norms Recommended for 1kg Export 1 (6S)-6-[5-[7-[2-(1R.3S,4S)-2-Azabicyclo [2.2.1] hept- 3-yi-1H-benzimidazol-6-yl]-9,9-difluoro-9H-fluoren-2- yl]-1H-imidazol-2-yl]-5-azaspiro [2.4] heptane Hcl (1:4) 0.965kg 2 N-Methoxy carbonyl-L-valine 0.70kg 2. (Rajkumar) PH:- 23071162 Department of Commerce. Udyog Bhawan. New Delhi.

F. NO.35011/156/2016-PI (Norms) Government of India /V Dated: September, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009- 14 Case of Wl/s Alphamed Formulations (P) Ltd. The undersigned is directed to refer to DGFT U-O.No. 01/82/50/1484/AM- 16/DES-3/234 dated the 8/7/16 vide which application from M/s Alphamed Formulations (P) Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Guronsan C Effervescent Tablets. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- DGFT is advised to call copy of master-batch formula duly authenticated by Q.C. incharge. 2. (Rajkumar) PH:-23071162 (Shri M.V. Singh. FTDO).

/ F.NO.35011/230/2016-PI (Norms) Government of India Dated: September, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14 Case of Wl/s Aurobindo Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/504/AM-17/DES- 3/376 dated the 17/8/2016 vide which application from M/s Aurobindo Pharma Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Lamivudine . This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- 8.No. Import item Norms Recommended for 1kg Export 1 Lamivudine coupled ester 2.19kg 2 Triethylamine 0.575kq 3 Sodium borohydride 0.480kg 4 Activated carbon 0.100kg 5 Acetone 0.518kq 6 Methanol 0.400kg 7 Toluene 0.203kg 8 Steam/Thermal coal -As per fuel piicy- 2. (Rajkumar) PH:-23071162

Case No.:68/5/82- !aLC4/2014 'Party Name;FDC LTD jHQFile |:0l/82/050/O0385/AMl5/ IRLA File 1:03/94/040/01125/AM14/ Meet No/Date: 18/82- ALC4/2014 18.02.2015 Lic.No/Date:03l6778140 11.04.2014 Status:Approved Defer Date: :98 IDecision : In the light of written comments received from Department of Pharmaceuticals vide jtheir OM No. 35011/499/2014-Pl(Norms) dated 11.02.2015, it was decided to ratify norms under, iPara 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. SI.No. Import items Qty. allowed :hloramphenicol eye drops 0.5%WA'OF 10.00 ML 1 Vial 1 . :hloramphen!col 0.051 gm per 10 ml vial 2. LDPEGRANULES As per packing policy |RA may take appropriate action as per the decision of Norms Committee.

/ ^ Wl-S F.NO.35011/253/2016-PI (Norms) Government of India Dated: .^.COctober, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.1) 2009-14 Case of Wl/s Wlorepen Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/457/AM-17/DES- 3/499 dated the 24/8/2016 vide which application from M/s Morepen Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Sitagliptin Phosphate IVionohydrate. This department has examined the matter and the following norms are furnished under para 4.7 of Fland Book of Procedures (Vol.1) 2009-14:- S.No. 1 Import item Norms Recommended for 1kg Export 1 (R)-3-amino-1-(3-(trifluoromethyl)-5,6-dihydro-7(8h)- yl]-4-(2,4,5,-trifluoro phenyl] butan-1-one mandelate salt 1.283kg 2 Methylene chloride 3.84kg 3 Isopropyl alcohol 2.88kg 2. (R^kurn^ar) PH:-23071162

-2^ F.NO.35011/251/2016-PI (Norms) Government of India " F \b Dated; (3 October, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.1) 2009-14 -Case of IVl/s Hetero Drugs Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/466/AM-17/DES- 3/490 dated the 24/8/2016 vide which application from M/s Fletero Drugs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Nebivolol Hcl. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S.No,. Import item Norms Recommended for 1kq Export 1 DIBAL-H 25% in toluene 18.02kq 2 Acetone 4.40kq 3 Diisopropyl ether 17.13kq 4 Toluene 7.00kq 5 Methanol 28.65kq 6 Dimethyl sulfloride 7.16kq 7 Methylene chloride 9.76kq 8 n-Hexane 31.05kg 9 5% palladium on carbon 0.100kg 2. (Rajkumar) PH:- 23071162 Directorate General of horeign Trade,

F.NO.35011/252/2016-PI (Norms) Government of India Depaiimeht of Pharmaceuticals W Dated; October, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.!) 2009-14 -Case of Wl/s Hetero Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/468/AM-17/DES- 3/462 dated the 23/8/2016 vide which application from M/s Fletero Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Tert. Butyl-2- ((4R,6S)-6-((E)-2-(4-(4-flurophenyl)-6-isopropyl-2-(N-methyl methane sulfonamide)pyrimidin-5-yI)-2,2-dimethyl-1,3-dioxane-4-yl)acetate. This department has examined the matter and the following norms are furnished under para 4.7 of Fiand Book of Procedures (Vol.!) 2009-14:- S.No. Import item Norms Recommended for 1kg Export 1 Tertiary butyl (4R-Cis)6-acetloxy methyl-2,2- dimethyl-1,3-dimethyl-4-acetate 1.09kg 2 5-bromo methyl-4-fluoro phenyl-6-isopropyl-2-methyl methyl sulfonyl amino pyrimldine 1.20kg 2. (Rajkumar) PH:- 23071162

./1: / ^\7^ Case No.: 134/6/82- ALC4/2014 Party NamerPARAMOUNT^ AROMACHEMPJ^^d-D., Meet No/Date:l 1/82- ALC4/2014 26.11.2014 HQ File :01/82/050/005p6/AM15/ RLA File^ :05/24/040/00485/AM14/ Lic,No/Date:0510382650 25.03.2014 220 IMC ngiii ui wiiucM Lommenis receivea rrom department ot Chemicals and Petrochemicals vide their U.O No. 14010/61/2010/Ch II dated 28.11.2014, it was decided to ratify norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less: Status:Approved Defer Date: Export Product Export Quantity S.No Import Product Quantity Allowed "ARVACROL 1kg 1. D-LIMONENE (LIMONENE, CITRUS TERRENE, ORANGE TERRENE, BRAZALIAN CITRUS TERRENE.STANDARD CITRUS TERRENE ORANGE OIL) 3.20 kg

F.NO.35011/213/2016-PI (Norms) Government of India Dated: October, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.1) 2009-14 -Case of M/s Glenmark Pharmaceuticals Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/377/AM-17/DES- 3/357 dated the 17/8./2016 vide which application from M/s Glenmark Pharmaceuticals Ltd, was sent to this Department for fixation of norms under para; 4.7 for the export of Ciclopirox Gel 0.77% 30gm, 45gm, lOOgm. This department has examined the matter and the following norms are furnished under para 4.7 of Fland Book of Procedures (Vol.1) 2009-14:- S.No. Import item Norms Recommended for Export of INo. Pack 30gm 45gm 100gm 1 Ciclopirox USP 236.Omg 352.72mg 785.Omg 2. (Rajkumar) PH:- 23071162

/ I ^ F. No.35011/99/2015-PI (Norms) Government of India Ministry of Chemicals & Fertilizers Udyog Bhawan,New Delhi, Dated the September, 2015 Office Memorandum Subject; - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s RA Chem Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1057/AM-15/DES- 3/1055 dated the 13/01/15 vide which application from M/s. RA Chem Pharma Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Ractopamine Hd. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S.No. Import Item Qty. Recommended kg/kg. 1. l-(4-Hydroxy Phenyl)-2-Amino Ethanol (Octopamine Hcl) 0.77 2. 4-(4-Hydroxy Phenyl)-2-Butanone 0.91 3. Methanol 1.87 4. Ethyl Acetate 2.44 (Bamali Khastgir) Phone:23071162

/
'2_ hi F.NO.35011/253/2016-PI (Norms) Government of India Dated: October, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14 Case of WI/s IWorepen Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/368/AM-17/DES- 3/494 dated the 24/8/2016 vide which application from M/s Morepen Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Montelukast Sodium. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14:- S.No. Import item Norms Recommended for 1kg Export 1 (S)-(E)-2-[2-[3-[2-(7-chloro-2-quinolinyl)-ethenyl phenyll-3-hydroxy propyll-phenyll-2-propanol 1.24kg 2 Methanol 2.325kg 3 N,N-Diisopropylethylamine 0.30kg 4 Tetrahydrofuran 3.15kg 5 Acetonitrile 2.95kg 6 2-[1-(mercaptomethyl) cyclopropyl] Acetic acid 0.40kg 2. (Rajkumar) PH:-23071162 (Shh M.V. Singh, FTDO),

.'tO ^ ! )2_ Case No.:I00/8/82-ALC4/2014 Party Name:IPCA LABORATORIES LIMITED Meet No/Date:4/82- ALC4/20!5 12.06.2015 lApproved HQ File ;01/82/050/00764/ AM15/ RLA File :03/94/040/00129/AM15/ Lic.No/Date:0310783592 29.05.2014 70 Decision : The committee decided to ratify the norms based on the recommendation of Department of Pharmaceuticals vide I.D.No35011/556/2014-PI (Norms) dt. April 2015 as per details given below or as applied by the firm whichever is lower:- Export product Qty Import items Qty. Kg./kg Etodolac I kg 7-EthyI Tryptophol 0.72 Methyl-3-Oxopentonoate 0.54 Methanol 1.14 RA may take further action accordingly.

I P Government of India Ministry of Chemicals and Fertilizers Department of Chemicals and Petrochemicals Subject; Advance Authoruation applicatiorvfrom Mis. Tide Industries for the import of material against the export of Rose Oxide etc. raw The applioationf has been examined and the Department recommends the following ^ norms for the present Advance. Authorization application. 1 Ifem of ■Export Qty. It^m oMfftPort Qty Aldehyde 012 Laurie tkg

1. C-12- ratty AiGohoI(Lauryi Aicohol) 1.726 kg V ^ . TTSLem of E>^3brt Qty. Item of Import ^ Qty Lauryl 1 kg
2. Laurie Acid- X. 1.22 kg
3. item of Export QtV.^■4.tem of Import QiVs L- Rose Oxide 1 kg 1.'trOitroneild 3.269^
4. Item of Export Qty. Item of Import Qtv & Rose Oxide 1 kg
5. Gitral (Citral Synthetic) 4.17 kg (A.K. AGARWAL) Addl. In.dustriahAdylser Tel. No. 011-2338.1430 Shri Mahender:Vjkram Sinqh;n:DO.-yDE^4ll) .0/o-DQFT. Ud.voaBhawan.NewDeihl-^il Deptt. of Q&PG U.O. No. 140i.d/40/'2011^CH4l dated 04.05'.2d1-6 i !.| i fS

Case No.:78/3/82-ALC4/20l4 iParty Name;HPL ADDITIVES CIM1TED(F0RMERLY KNOWN HIGH POLYMER !HQ File i:OI/82/050/00082/AM15/ iRLA File :;05/23/040/00477/AM14/ Meet No/Date:3/82- :ALC4/20]4 i08.05.20i4 iLic.No/Daie^5Y038027^ i26.02.2014 Status:Case Approved Defer Dale: Decision : In the light of written comments received from Department of Chemicals and; Petrochemicals vide their U.O No. 14010/7/2011-Ch. il dated 26.03,2013, it was decided to ratify norms under Para 4.7 of HBP vl as per details given below or as applied by the firm,' whichever is less: 1394 Export product Export Quantity S.No. Import items Quantity Allowed l,3,5-TRlMETHYL-2.4,6-TRiS(3,5-D]- TERT-BUTYL-4.HYDR0XYBENZYL) BENZENE (KINOX-30) 1 kg 1. 2,6-DI -TERTIARY BUTYL PHENOL l.I2kg 2. PARAFORMALDEHYDE (PF) 96% 0.172 kg 3. MESITYLENE 0.198 kg 4. METHYLENEDICHLORIDE 1.00 kg 5. MBTHANOL 1.00 kg ,RA may take appropriate action as per the decision of Norms Committee.

(2^fcn) F. NO.35011/161/2016-PI (Norms) Government of India Dated: September. 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (VoLI) 2009- 14 Case of M/s Fresenius KabI Oncology Ltd. IS directed to refer to DGFT U.O.No. 01/82/50/229/AM- M/s Fresenius Kabi The undersigned 17/DES-3/251 dated the 8/7/16 vide which application from Oncology Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Etoposide injections 100mg/5ml, 200mg/10ml, 500mg/25ml, 1000mg/50ml. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S.No. Import item Norms Recommended for 1 No. injection 100mg 200mg 500mg lOOOmg 1 Etoposide llOmg 220mg 525mg 1050mg 2 Dehydrated alcohol 1.525ml 3.05mi 7.625ml 15.25ml 3 Glass vials Relevant, as per packing policy 4 Rubber stopper 2. (Rajkumar) PH:- 23071162

F. NO.35011/134/2016-PI (Norms) Government of India Dated: July, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.1) 2009- 14 Case of Wl/s Saurav Chemicals Ltd. The undersigned 17/DES-3/225 dated the is directed to refer to DGFT U.O.No. 01/82/50/289/AM- 6/7/16 vide which application from M/s Saurav Chemicals Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Dexketoprofen Trometamol. This department has examined the matter and the following norms are furnished under para 4.7 of Fland Book of Procedures (Vol.1) 2009-14:- ■irv;-. ' S.No. Import item Norms Recommended for 1 kg Export 1 Ketoprofen 1.50kg 2 N-octyl-D-Glucamine 0.36kg 3 Tromethamlne. . 0.36kg s.. 2. (Rajkumar) PH:- 23071162 (Shri M.V. Singh. FTDO).

. V F. No.3501 1/153/2014-PI (Norms) Government of India Ministry of Chemical & Fertilizers Udyog Bhawan. New Delhi, the October. 2015 Office Memorandum Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.1) 2009-14 Case of M/s Alembic Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/82/AM-l6/r3LS-j/.34 dated the 12/06/15 vide which application from M/s. Alembic Pharma Ltd was sent to this Department for fixation of norms under para: 4.7 for the export o! Azithromycin Stcp-4. I his department has examined the matter and the following norms are furnished under para 4.7 of riand Book of Procedures (Vol.1) 2009-14:- S.No. Import Item Qly. Recommended. 1. Erythromycin Base USP 1.75 kg/kg A 2. Hydroxylamine 1 Icl 0.91 Melhanol 2.72 4. Methane Sulfonyl Chloride 0.72 5. Acetone 6.45 6. Ethyl Alcohol 2.81 7. Platinum Catalyst with base of Activated Carbon (5% pt/c) 1 .OOgm/kg A Directorate General of Foreign Trade. Department of Commerce. (Shri M.V. Singh. FTDO). Udyog Bhawan. New Delhi (Barnali Khasigir) Phone:23071 162

F. No.35011/857/2015-PI (Norms) ■Government of India Shastri Bhawan, New Delhi, the September 8, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.!) 2009-14 Case of IW/s Ashish Life Scjence (P) Ltd. The undersigned is directed to refer to DGFT U.O. Nos. 01/82/050/881/AM-13/DES- 3/1723 dated the 01.03.2016 vide which application from M/s Ashish Life Science (P) Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Veterinary Formulation in the form of Bolus. The applicant has requested to import only Rice Starch BP to be used as exclplent and no API is to be imported. This department has examined the matter based upon the additional information fonwarded vide above referred communication of the DGFT and the following norms are furnished against this application: - s No. Export Item Quantity Import Item Quantity allowed for 1000 Bolus 1. Afridazole Bolus 15 gm (each Bolus containing Albendazole 2500 mg) 1000 Bolus Rice Starch BP 2300 gm 2. Tetracozash 900 Bolus(each Bolus containing 450 mg Oxyclozanide and 450 mg Tetramisole) 1000 Bolus Rice Starch BP 1550 gm 2. This Issues with the approval of competent authority (Raj Kumar) Phone: -23071162 Email: uspi3-pharma@nlc.in Directorate-General of Foreign Trade,

cv \ o I 'I Case No. B- 03 M.N0.O8/AM 16 Date 16.09.2015 M/s. Wanbury Ltd File NO.01/82/50/00492/AM-12 Adv.Auth. No. 0310641073 dt. 07.07.2011 Decision: The committee decided to ratify the norms based on the recommendation of Department of Pharmaceuticals vide O.M.No. 35011/35 /2014-PI (Norms) dt. February, 2015 as per details given below or RA may Export product Qty. Import items Qty. PAROXETINE HYDROCHLORIDE EP 1kg 1 (3S,4R(-4-FLUOROPHENYL)-3- HYDROXYMETHYL-1- METHYLPIPERDINE(S- CARBOINOL) 0.810 kg /kg 2 TOSYL CHLORIDE 0.98 kg /kg 3 TRIETHYLAMINE 0.68 kq /kq 4 DIMETHYL AMINO PYRIDINE 0.017 kq /kg 5 DICHLOROMETHANE 7.95 lit./kg 6 SESAMOL 0.55 kq./kq 7 TOLUENE 4.65 lit./kq 8 PHENYLCHLOFORMATE 0.64 lit/kq 9 METHANOL 0.40 lit/kq ake further action according y-

31 A32 Deleted A33 6-APA A34 Deleted A35 A36 5-Bromo Nicotinic Acid 1 kg Nicotinic Acid 0.837 kg Thionyl Chloride 0.48 kg 1kg vy 7-ADCA (From Pen G. Route) A37 A38 A39 A40 A41 A42 7-Chloro-6-Fluoro-1- CyclopropyI-1-4- Dihydro-4- Oxoqui- noline-3-Carb- oxilic Acid (Drug intermediate for Ciprofloxacin) 1 kg 7-Dehydro Cholestrol (100% purity) Acetazolamide 1kg Acetyl Salicylic Acid IKg Acriflavin/ Acriflavin Hydrochloride/ Acriflavin neutral BPC/ Eu-Flavin NFX/Proflavin Hemisulphate Actovegin Injection 5 ml Ampoule containing Actovegin concentrate not less than 1113 mg Actovegin Jelly 20% w/w (each gm. of Jelly containing De- 1 kg 1 kg 25 Ampouls of 5 ml each 1 Tube of 20 gms. Penicillin G Potassium First Crystals 2.92 BOU Methanol 0.04 kg / 3 Methylene Chloride 0.83 kg Penicillin 0 Potassium First Crystal Acetic Acid Hydrogen Peroxide 60% Pyridine Hydrobromide Bis Trimethyl Silyl Urea OR a) Hexamethyl Disilazane Methylene Chloride Penicillin 0 Amidase (Enzyme) 2,4-Dichloro-5-Fluoro Acetophenon Sodium Hydride 3.667 BOU 1.45 kg 0.569 kg 0.5040 kg 2.40 kg 2.2569 kg 0.073 kg 2.097 gm 1.01 kg 0.34 kg Dimethyl Carbonate 1.14 kg Cyclopropylamine 0.23 kg Dimethyl Formamide 1.14 kg Cholesteryl Acetate 2,4,6 Collidine Petroleum Ether Hydrazine Hydrate 80% Ammonium Thio Cyanate Acetic Acid Glacial Charcoal Activated (Pharma grade) Hypo Phosphorous Acid 50% 3ure (catalyst) Phenol Acetic Anhydride Meta Phenylene Diamine Glycerine Formic Acid Acetone Actovegin Actovegin concentrate (Deproteinized Haemoderivative of Calfs 3.00 kgs 0.36 kg 11.66 Ltrs 0.73 kg 2.03 kg 2.35 kg 0.15 kg 0.19 kg 0.700 kg 0.750 kg 2.300 kg 5.000 kg 1.000 kg 6.000 kg 29.716 ml. 0.852 ml. A4

% Ampicillin Anhydrous from Pen G route 1 kg 1 Penicillin G Potassium first crystal 2.088 BOU 2 Pivaloyl chloride 0.42 kg 3 Triethyiamine 0.0239 kg 4 Methylene Chloride 1.50 kg 5 D(-) Alpha Phenyl Glycine Base 0.500 kg 6 Pen. G Amidase (Enzyme) 1.078 gm 7 Ethyl Aceto Acetate 0.45 kg 8 Isopropyl alcohol 1.21 kg 9 Pot. Carbonate 0.235 kg A61 Deleted A62 Ampidllin Capsules 250 mg each capsule containing ampicillin trihydrate equivalent to 250 mg. ampicillin base 1000 Capsules 1 Ampicillin Trihydrate 0.2945kg A63 Deleted A64 Deleted A65 Ampicillin injection-250 mg (Ampicillin Sodium Injection) (Each vial contains Ampicillin Sodium equivalent to Ampicillin 250 mg) 1000 vials 1 Ampicillin Sodium 292.30 gms A66 Ampicillin oral suspension (Ampicillin Syrup) 125 mg/5 ml, 60 ml bottle (each 5 ml contains Ampicillin Trihydrate equivalent to 125 mg of Ampicillin) 1000 Bottles 1 Ampicillin Trihydrate 1818.86 gms A67 Ampicillin Sodium Sterile (6 APA/Pen G Route) 1 kg 1 6-APA OR 0.72 kg 1 a) Penicillin G Potassium First Crystal 2.17 BOU b) Penicillin G Amidase 1.12 gm 2 Pivaloyl Chloride 0.436 kg 3 Triethyiamine 0.0248 kg 4 Methylene chloride 1.56 kg 5 D(-) Alpha Phenyl Glycine Base 0.520 kg 6 Ethyl Aceto acetate 0.468 kg 7 Sodium Thiocynate 0.3075 kg 8 Acetonitrile 1.41 kg 9 Isopropyl Alcohol / Acetone 1.25 kg 10 Potassium Carbonate 0.244 kg A68 Ampicillin Trihydrate (From 6- APA Route) 1kg 1 6-APA 0.596 kg 2 a) D (-) Alpha Phenyl Glycine Base 0.417 kg b) Ethyl Aceto Acetate 0.416 kg c) Potassium Carbonate 0.196 kg A7

OR 2 D (-) Alpha Phenyi Glycine Ethyl Aceto Acetate Potassium Dane Salt 0.876 kg 3 Triethylamlne 0.020 kg 4 Methylene Chloride 0.9797 kg 5 N,N-Dimethyl Acetamide 0.010 kg 6 Isopropyl Alcohol 0.399 kg 7 Acetone 0.0974 kg 8 PivaloyI Chloride 0.350 kg A69 Ampicillin Trihydrate (From Pen. G Route) 1 kg 1 Penicillin G Potassium First Crystals 1.74 BOU 2 Penicillin G Amidase (Enzyme) 0.903 gm. 3 D (-) Alpha Phenyi Glycine Ethyl Aceto Acetate Potassium Dane Salt OR 0.876 kg 3 a) D (■) Alpha Phenyi Glycine Base 0.417 kg b) Ethyl Aceto Acetate 0.416 kg c) Potassium Carbonate 0.196 kg 4 Triethylamine 0.020 kg 5 Methylene Chloride 1.25 kg 6 Iso Propyl Alcohol 0.399 kg 7 N,N-Dimethyl Acetamide 0.010 kg 8 PivaloyI Chloride 0.350 kg 9 Acetone 0.1453 kg A70 Analgin 1 kg 1 Aniline Oil 0.730 kg 2 Methyl Aceto acetic ester 0.800 kg 3 Sodium Nitrite 1.050 kg A71 Analgin (from PMP Route) 1kg 1 l-Phenyl-3-Methyl- 5- Pyrazolone 0.830 kg 2 Sodium Nitrite 0.438 kg A72 Analgin lnjection-5 ml ampoules (Each ml. containing 500 mg of 1000 ampoules 1 Aniline Oil 2.0075 kgs analgin) 2 Methyl Aceto Acetic Ester 2.20 kg 3 Sodium Nitrite 2.8875 kg A73 Analgin Tablets-500 mg 1000 Tablets I Aniline Oil 372.3 gms 2 Methyl Aceto Acetic ester 408.02gms 3 Sodium Nitrite 535.5 gms A74 Anisole 1 kg 1 Phenol 1.007 kg 2 Di-Methyl Sulphate 0.770 kg 3 Caustic Soda Lye 0.486 kg A75 Antipyrine Salicylate (Phenazone IKg. I Aniline Oil 0.55 Kg Salicylate) 2 Aceto Acetic Methyl Ester 0.62 Kg A8

% 63 (
J Page 1 of I Case Nd::2H/48/82-ALC4/2010 Party NamerDSM ANTI- INFECTIVES INDIA LTD Meet No/Date;50/82- ALC4/2010 15.03.2011 Status:Case I Approved nu Nie :ui/82/050/01684/AM11/ KLA Hie :22/24/040/00074/AM11/ Llc.No/Date:2210010734 technical authority present in meeting in consultation with technical authority present in meeting, decided to ratify norms under para 4 applied by fi .7 of HBP as per detaH^Z^ras rm whichever is lowen- Export product Exp. Qtv. SI.No Import items Qty. allowed Amplcillln Trihydrate through 6-APA through Enzyme Route 6-Amino Pencillanice Acid Oxilase (HL) spherical balls In suspensionof brown colour D(-) Alpha Phenyl Glycine Base Colourless to Greyishwhite Crystalline Powder Methanol Transparent 0.596 kg 5.25 gram 0.417 kg RA concemed may take further necessary action as per above decision of NC. 0.400 kg http://dgft.gov.in/exim/2000/cominittee/meet_adv4_5011.htm 04-11-2016

Ofifice of Directorate GengtalrfForeign Trade Page 1 of 1 2- SI Case No.:92/41/82-ALC472010 Party Name:DSM ANTI- INFECTIVES INDIA LTD Meet No/Date:41/82- ALC4/20I0 11.01.2011 Lic.No/Date;2210010247 105.08.2010 StatusrCase Approved consultation with technical authority nresent in V fa «4»1-20I0 and in per details helow or as applied

Export product Amoxycillin Trihydrate Exp. Qty. SI.No. Import items IKg. I. 2. 3. 6-Amino Penicillanic Acid Qxllasa (Enzyme^ I Qty. allowed 0.568 kg j 5.00 ^m. D(-) P-Hydroxy Phenyl Glycine Methylester 0.608 kg RA concerned may take further necessary action as per above decision of NC. http://dgft.gov.in/exiin/2000/committee/meet_adv4__4111 .htm 04-11-2016

Office of Directorate General of Foimn Trade M Page 1 of 1 Case No.:112/40/82-ALC4/2Q10_ HQ File :01/82/050/013n/AMll/ RLA File :22/24/040/00077/AM09/ Decision • Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceutieals vide tlieir O.M. No.3S01I/311/2009-PI (Norms) dated 13.05.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Lic.No/Date;2210010145 02.07.2010 ^fty NamerDSM ANTI- INFECTIVES INDIA PVT LTD Meet No/Date:40/82- ALC4/2010 04.01.2011 Status:Case Approved Export product Exp. Qty. SI.No. Import items Qty. allowed Ampicillin Trihydrate IKg. 1. Pencillin G Potassium P* Crystal 1.74 BOU 2. Pencillin G Amedise (Enzyme) 0.903 gram 3. Sodium Hydroxide 0.354 kg 4. Formidase 5.00 gram 5. D-Alpha Phenyl Glycine Base 0.417 kg 6. Sodium Sulphate 0.251 kg 7. Methanol 0.400 kg 37 RA concerned may take further necessary action as per above decision of NC. http://dgft.gov.in/exim/2000/coinmittee/meet_adv4_40n .htm 21-11-2016

Case No.:75/10/82-ALC4/2013 HQ File :01/82/050/00258/AM14/ Decision ■: In the light of earlier decision taken in meeting no. 5/82; dated 30.5.2013, it was decided to ratify norms under Para 4.7 of HBP vl as per details given be ow or as applied by the firm, whichever is le^^ -••• I Import itenis I Quantity allowea ' kg/kg Export Product Quantify Sl.No. 378 Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. RLA File :22/24/040/00079/AM13/ Page 1 of 1 MeetNo/Date;10/82- ALC4/2013 22.08.2013 1 Lic.No/Date:22100139il 04.06.2013 [. . 1 Status:Case Approved Defer Date: AMPICILLIN TRIHYDRATE THROUGH 6-APA ROUTETHROUGH ENZYMATIC ROUTE I kg 6-AMINq fJENICILLANIC ACIDE(6-APA) ■ TECH.SPEC.:- white to off- white powder assy not less than 96% 2. 3. 4. FORMIDASE (ENZYME) TECH.SP&SPHERICAL BALLS IN SUSPENSION OF brown'gqlour 0.596 D(-)Alph'a|^henyl Glycihe Base; TECH.SF!EC.:- white to almost I white crystalline powder min. j assay not.less than 99%. [I 5.00igm/kg 0.417 METHANpL TECH:SPEC :- TRANSPARENT AND COLORLESS LIQUID ASSY NOT LESS THAN 98% 0.400 httl3://dgft.gov4iVexim/2000/conmittee^t^v4_1014.te 21-11-2016