Government of India Ministry of Commerce and Industry Directorate General of Foreign Trade Maulana Azad Road, New Delhi 110011 Norms Committee-III Para 4.7 Decision Meeting No. 16/82/2016 of 2016-17 dated 28.12.2016 to consider the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products and falling under Chapter 29 and 30, scheduled to be held on 28.12.2016 but actually held on 31.01.2017 under the Chairmanship of Shri J.V. Patil, Addl. DGFT in Room No.04, Udyog Bhawan, New Delhi. Following members were present:- Shri Nirmal Kumar, Dy. Director General of Foreign Trade Shri Amit Parikh, Scientist “D”, D/o Biotechnology Shri V.K. Tyagi, Consultant, D/o Pharmaceuticals. The committee went through the minutes of earlier meeting No. 15/82 dated 15.12.2016 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 : 16/82-ALC4/2016 MEETING DATE : 28.12.2016 1 Case No.:15/2/82-ALC4/2016 Party Name:PERFECT INDUSTRIES PRIVATE LIMITED. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00015/AM17/ RLA File :03/95/040/00554/AM12/ Lic.No/Date:0310659678 14.10.2011 Defer Date: 15.02.2017 Decision : Deferred. 2 Case No.:38/19/82-ALC4/2014 Party Name:PORUS LABORATORIES PVT LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/01526/AM15/ RLA File :09/24/040/00050/AM13/ Lic.No/Date:0910052706 21.05.2012 Defer Date Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.27/82 dated 29.12.2012 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

3 Case No.:131/16/82- ALC4/2016 Party Name:SARNA CHEMICALS PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00948/AM17/ RLA File :52/24/040/00043/AM13/ Lic.No/Date:5210039465 14.02.2013 Defer Date: Decision :Deferred. 4 Case No.:173/5/82- ALC4/2015 Party Name:FORACE POLYMERS (P) LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00313/AM16/ RLA File :05/23/040/00069/AM14/ Lic.No/Date:0510356983 13.06.2013 Defer Date: 15.02.2017 Decision :Deferred. 5 Case No.:61/4/82-ALC4/2016 Party Name:ADCOCK INGRAM LTD, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00124/AM17/ RLA File :07/24/040/00097/AM14/ Lic.No/Date:0710096460 04.07.2013 Defer Date: 15.02.2017 Decision : The Committee noted that information has been called for from the firm by NC in its meeting No.12 dated 28.09.2016 is awaited. The committee accordingly decided to await the reply and deferred the case. 6 Case No.:31/4/82-ALC4/2014 Party Name:UNIVERSAL BIOFUELS PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 7 Case No.:41/16/82-ALC4/2013 Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00854/AM14/ RLA File :07/24/040/00188/AM14/ Lic.No/Date:0710098283 16.09.2013 Defer Date: Decision : The Committee decided to ratify norms based on the SION A-3677 published earlier, 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. 8 Case No.:48/13/82- ALC4/2015 Party Name:BELCHEM INDS. INDIA PVT. LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01011/AM16/ RLA File :03/94/040/00860/AM14/ Lic.No/Date:0310766718 17.01.2014 Defer Date: 15.02.2017 Decision :Deferred. 9 Case No.:57/3/82-ALC4/2014 Party Name:JUBILANT LIFE Meet No/Date:16/82- Status:Deferred

SCIENCES LIMITED ALC4/2016 28.12.2016 HQ File :01/82/050/00061/AM15/ RLA File :05/23/040/00506/AM14/ Lic.No/Date:0510382053 18.03.2014 Defer Date: 15.02.2017 Decision :Deferred. 10 Case No.:49/13/82- ALC4/2015 Party Name:BELCHEM INDS. INDIA PVT. LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 11 Case No.:237/6/82-ALC4/2014 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00639/AM15/ RLA File :17/24/040/00002/AM15/ Lic.No/Date:1710005803 05.05.2014 Defer Date: taken by NC in its meeting No.06/82 dated 10.05.2011 , uploaded at the end of these minutes or 12 Case No.:7/8/82-ALC4/2016 Party Name:MACSON PRODUCTS Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00345/AM17/ RLA File :52/21/040/00011/AM15/ Lic.No/Date:5210041026 12.05.2014 Defer Date: 15.02.2017 Decision :Deferred. 13 Case No.:13/2/82-ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00028/AM16/ RLA File :05/23/040/00080/AM15/ Lic.No/Date:0510387607 28.05.2014 Defer Date: taken by NC in its meeting No.45/82 dated 07.02.2012 , uploaded at the end of these minutes or 14 Case No.:38/8/82- ALC4/2014 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00702/AM15/ RLA File :09/24/040/00108/AM15/ Lic.No/Date:0910060258 28.05.2014 Defer Date: 15.02.2017 Decision : Deferred for want of comments from DoP. 15 Case No.:165/6/82- ALC4/2014 Party Name:HALDIA PETROCHEMICALS LTD. Meet No/Date:16/82- ALC4/2016 Status:Deferred

28.12.2016 HQ File :01/82/050/00567/AM15/ RLA File :02/24/040/00037/AM15/ Lic.No/Date:0210203844 05.06.2014 Defer Date: 15.02.2017 Decision :Deferred. 16 Case No.:166/6/82-ALC4/2014 Party Name:KORES (INDIA) LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00568/AM15/ RLA File :31/83/040/00033/AM15/ Lic.No/Date:3110064371 13.06.2014 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier recommendation forwarded by D/o Pharmaceuticals vide O.M.No.35011/464/2014-PI(Norms) dated 26.02.2015 , 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. 17 Case No.:202/6/82- ALC4/2014 Party Name:FORACE POLYMERS (P) LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00604/AM15/ RLA File :05/23/040/00139/AM15/ Lic.No/Date:0510389232 01.07.2014 Defer Date: 15.02.2017 Decision :Deferred. 18 Case No.:30/9/82-ALC4/2014 Party Name:SOFTGEL HEALTH CARE PVT. LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00827/AM15/ RLA File :04/24/040/00033/AM15/ Lic.No/Date:0410159122 30.07.2014 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/610/2012-PI(Norms) dated 06.02.2013, 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. 19 Case No.:203/5/82- ALC4/2015 Party Name:ALKALOIDS CORPORATION Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Approved HQ File :01/82/050/00343/AM16/ RLA File :02/24/040/00080/AM15/ Lic.No/Date:0210204732 07.08.2014 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/437/2015-PI(Norms) dated August 2015, 20 Case No.:264/13/82- ALC4/2014 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred.

21 Case No.:255/13/82- ALC4/2014 Party Name:THE DHARAMSI MORARJI CHEMICAL CO LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 22 Case No.:377/5/82-ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00517/AM16/ RLA File :03/94/040/00493/AM15/ Lic.No/Date:0310788472 27.08.2014 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/783/2015-PI(Norms) dated 22.08.2016, uploaded 23 Case No.:263/13/82- ALC4/2014 Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01266/AM15/ RLA File :03/94/040/00962/AM14/ Lic.No/Date:0310788558 01.09.2014 Defer Date: 15.02.2017 Decision :Deferred. 24 Case No.:217/13/82- ALC4/2014 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision : It was noted that fraudulent CA certificates have been submitted in this case. The matter is under investigation. The Committee accordingly decided to defer the case. 25 Case No.:59/13/82-ALC4/2014 Party Name:HELLO PAINTS (P) LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/01062/AM15/ RLA File :05/23/040/00276/AM15/ Lic.No/Date:0510391245 19.09.2014 Defer Date: taken by NC in its meeting No.35/82 dated 29.11.2011 , uploaded at the end of these minutes or 26 Case No.:9/15/82- ALC4/2014 Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01296/AM15/ RLA File :09/24/040/00327/AM15/ Lic.No/Date:0910061001 19.09.2014 Defer Date: 15.02.2017 Decision : Information called for from the firm in NC meeting No.04/82 dated 24.05.2016 is

awaited. The committee accordingly deferred the case. 27 Case No.:17/13/82- ALC4/2014 Party Name:GRASIM INDUSTRIES LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01020/AM15/ RLA File :34/24/040/00155/AM15/ Lic.No/Date:3410040570 23.09.2014 Defer Date: 15.02.2017 Decision :Deferred for want of comments from MSME. 28 Case No.:74/13/82-ALC4/2014 Party Name:CONSTECH ENTERPRISES PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/01077/AM15/ RLA File :05/23/040/00282/AM15/ Lic.No/Date:0510391308 24.09.2014 Defer Date: taken by NC in its meeting No.15/82 dated 31.10.2013 , uploaded at the end of these minutes or 29 Case No.:19/13/82- ALC4/2014 Party Name:SANO MEDICAL KITS PVT. LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01022/AM15/ RLA File :04/24/040/00171/AM15/ Lic.No/Date:0410159504 29.09.2014 Defer Date: 15.02.2017 Decision : Information from firm has been received and sent to DoP for comments. 30 Case No.:134/13/82- ALC4/2014 Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01137/AM15/ RLA File :52/24/040/00031/AM15/ Lic.No/Date:5210041251 07.10.2014 Defer Date: 15.02.2017 Decision :Deferred. 31 Case No.:42/15/82- ALC4/2014 Party Name:PVS AGRO VET Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01329/AM15/ RLA File :09/24/040/00246/AM15/ Lic.No/Date:0910061105 16.10.2014 Defer Date: 15.02.2017 Decision : Firm has furnished information vide letter dated 06.06.2016 and the same has been sent to DoP on 04.08.2016. The Committee accordingly deferred the case. 32 Case No.:110/13/82- ALC4/2014 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01113/AM15/ RLA File :34/24/040/00188/AM15/ Lic.No/Date:3410040635 22.10.2014 Defer Date: 15.02.2017 Decision :Deferred.

33 Case No.:86/10/82- ALC4/2014 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:16/82- ALC4/20 16 28.12.2016 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: 15.02.2017 Decision :Deferred. 34 Case No.:266/13/82- ALC4/2014 Party Name:ATUL LIMITED, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01269/AM15/ RLA File :08/24/040/00289/AM15/ Lic.No/Date:0810133735 05.11.2014 Defer Date: 15.02.2017 Decision :Deferred. 35 Case No.:268/13/82- ALC4/2014 Party Name:ATUL LIMITED, Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 36 Case No.:107/13/82- ALC4/2014 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01110/AM15/ RLA File :34/24/040/00196/AM15/ Lic.No/Date:3410040655 05.11.2014 Defer Date: 15.02.2017 Decision :Deferred. 37 Case No.:111/13/82- ALC4/2014 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01114/AM15/ RLA File :05/23/040/00352/AM15/ Lic.No/Date:0510391927 11.11.2014 Defer Date: 15.02.2017 Decision :Deferred. 38 Case No.:61/18/82-ALC4/2014 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/01427/AM15/ RLA File :34/24/040/00198/AM15/ Lic.No/Date:3410040676 11.11.2014 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.03/82 dated 08.05.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP. RA concerned may take further necessary action as per the decision of NC. 39 Case No.:100/4/82- ALC4/2015 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred

HQ File :01/82/050/00139/AM16/ RLA File :17/24/040/00125/AM15/ Lic.No/Date:1710005978 12.11.2014 Defer Date: 15.02.2017 Decision :Deferred. 40 Case No.:120/13/82- ALC4/2014 SCIENCES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01123/AM15/ RLA File :05/23/040/00325/AM15/ Lic.No/Date:0510391947 12.11.2014 Defer Date: 15.02.2017 Decision :Deferred. 41 Case No.:65/15/82- ALC4/2014 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01352/AM15/ RLA File :05/23/040/00360/AM15/ Lic.No/Date:0510392011 14.11.2014 Defer Date: 15.02.2017 Decision : Deferred for want of comments from AYUSH. 42 Case No.:74/18/82- ALC4/2014 Party Name:ADESHWAR MEDITEX PVT. LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01440/AM15/ RLA File :03/94/040/00814/AM15/ Lic.No/Date:0310791373 25.11.2014 Defer Date: 15.02.2017 Decision :Deferred. 43 Case No.:18/18/82-ALC4/2014 Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/01384/AM15/ RLA File :03/94/040/00792/AM15/ Lic.No/Date:0310791374 25.11.2014 Defer Date: taken by NC in its meeting No.13/82 dated 17.07.2012 , uploaded at the end of these minutes or 44 Case No.:32/2/82- ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00032/AM17/ RLA File :03/95/040/00617/AM15/ Lic.No/Date:0310791470 27.11.2014 Defer Date: 15.02.2017 Decision :Deferred. 45 Case No.:92/18/82-ALC4/2014 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/01458/AM15/ RLA File :34/24/040/00224/AM15/ Lic.No/Date:3410040732 28.11.2014 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by

NC in its meeting No.03/82 dated 08.05.2014, uploaded at the end of these minutes or as 46 Case No.:82/18/82- ALC4/2014 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01448/AM15/ RLA File :05/23/040/00413/AM15/ Lic.No/Date:0510392368 10.12.2014 Defer Date: 15.02.2017 Decision : Deferred for want of comments from AYUSH. 47 Case No.:101/4/82- ALC4/2015 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00140/AM16/ RLA File :17/24/040/00144/AM15/ Lic.No/Date:1710005998 10.12.2014 Defer Date: 15.02.2017 Decision :Deferred. 48 Case No.:97/18/82- ALC4/2014 Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01463/AM15/ RLA File :30/24/040/00041/AM15/ Lic.No/Date:3010103261 11.12.2014 Defer Date: 15.02.2017 Decision :Deferred. 49 Case No.:2/18/82- ALC4/2014 Party Name:SWATI MENTHOL & ALLIED CHEMICALS LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01368/AM15/ RLA File :29/24/040/00009/AM15/ Lic.No/Date:2910025185 17.12.2014 Defer Date: 15.02.2017 Decision :Deferred. 50 Case No.:88/18/82- ALC4/2014 Party Name:METROPOLITAN EXIMCHEM LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01454/AM15/ RLA File :03/95/040/00776/AM15/ Lic.No/Date:0310792133 18.12.2014 Defer Date: 15.02.2017 Decision :Deferred. 51 Case No.:69/18/82- ALC4/2014 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01435/AM15/ RLA File :03/95/040/00649/AM15/ Lic.No/Date:0310792132 18.12.2014 Defer Date: 15.02.2017 Decision :Deferred. 52 Case No.:105/18/82- Party Name:KLJ Meet No/Date:16/82- Status:Deferred

ALC4/2014 PLASTICIZERS LTD., ALC4/2016 28.12.2016 HQ File :01/82/050/01471/AM15/ RLA File :05/23/040/00436/AM15/ Lic.No/Date:0510392586 26.12.2014 Defer Date: 15.02.2017 Decision :Deferred. 53 Case No.:84/18/82-ALC4/2014 Party Name:HESTER BIOSCIENCES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Rejected. HQ File :01/82/050/01450/AM15/ RLA File :08/24/040/00362/AM15/ Lic.No/Date:0810134170 30.12.2014 Defer Date: Decision : The Committee noted that information had been called for from the firm in NC meeting No.04 dated 12.06.2015 but it has not been received so far. 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. 54 Case No.:112/18/82- ALC4/2014 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/01478/AM15/ RLA File :05/24/040/00450/AM15/ Lic.No/Date:0510392619 30.12.2014 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/141/2015-PI(Norms) dated Oct. 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. 55 Case No.:19/4/82- ALC4/2015 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00058/AM16/ RLA File :03/94/040/00932/AM15/ Lic.No/Date:0310792548 01.01.2015 Defer Date: 15.02.2017 56 Case No.:137/5/82-ALC4/2015 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00277/AM16/ RLA File :03/94/040/00931/AM15/ Lic.No/Date:0310792547 01.01.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/708/2015-PI(Norms) dated 17.03.2016, uploaded 57 Case No.:85/18/82-ALC4/2014 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/01451/AM15/ RLA File :05/24/040/00412/AM15/ Lic.No/Date:0510392654 01.01.2015 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in

its meeting No.03/82 dated 08.05.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 58 Case No.:28/15/82-ALC4/2014 Party Name:DR REDDYS Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/01315/AM15/ RLA File :09/24/040/00502/AM15/ Lic.No/Date:0910061479 02.01.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/301/2015-PI(Norms) dated October 2015, 59 Case No.:151/5/82-ALC4/2015 Party Name:AGIO PHARMACEUTICALS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00291/AM16/ RLA File :03/94/040/00902/AM15/ Lic.No/Date:0310792875 13.01.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/545/2012-PI(Norms) dated 27.12.2012, uploaded 60 Case No.:92/5/82- ALC4/2015 Party Name:ALKALOIDS CORPORATION Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00232/AM16/ RLA File :02/24/040/00203/AM15/ Lic.No/Date:0210205448 14.01.2015 Defer Date: 15.02.2017 Decision : The Committee noted that COA of the imported details leaves from the foreign supplier have been called for from the firm in NC meeting No.14 dated 29.11.2016 but it has not been received so far. The Committee decided await the reply and deferred the case. 61 Case No.:9/18/82- ALC4/2014 Party Name:SAIBABA SURFACTANTS (P) LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01375/AM15/ RLA File :08/24/040/00371/AM15/ Lic.No/Date:0810134344 19.01.2015 Defer Date: 15.02.2017 Decision :Deferred. 62 Case No.:204/5/82- ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00344/AM16/ RLA File :09/24/040/00596/AM15/ Lic.No/Date:0910061555 23.01.2015 Defer Date: 15.02.2017 Decision :Deferred. 63 Case No.:230/5/82-ALC4/2015 Party Name:R.K.INDUSTRIES, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved

HQ File :01/82/050/00370/AM16/ RLA File :08/24/040/00394/AM15/ Lic.No/Date:0810134414 28.01.2015 Defer Date: taken by NC in its meeting No.18/82 dated 02.08.2011, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take 64 Case No.:20/4/82- ALC4/2015 Party Name:D. R. COATS INK & RESINS PVT. LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00059/AM16/ RLA File :03/94/040/00759/AM15/ Lic.No/Date:0310793542 03.02.2015 Defer Date: 15.02.2017 Decision :Deferred. 65 Case No.:6/18/82-ALC4/2014 Party Name:GRANULES INDIA LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/01372/AM15/ RLA File :09/24/040/00576/AM15/ Lic.No/Date:0910061577 03.02.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/204/2013-PI(Norms) dated 03.07.2013, uploaded 66 Case No.:11/18/82-ALC4/2014 Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/01377/AM15/ RLA File :09/24/040/00561/AM15/ Lic.No/Date:0910061599 10.02.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/461/2015-PI(Norms) dated November 2015, 67 Case No.:33/4/82-ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00072/AM16/ RLA File :05/24/040/00471/AM15/ Lic.No/Date:0510393135 11.02.2015 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.15/82 dated 12.07.2011, 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. 68 Case No.:121/18/82- ALC4/2014 Party Name:HETERO LABS LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/01487/AM15/ RLA File :09/24/040/00645/AM15/ Lic.No/Date:0910061606 12.02.2015 Defer Date:

Pharmaceuticals forwarded vide O.M.No.35011/266/2014-PI(Norms) dated October 2014, 69 Case No.:133/7/82-ALC4/2016 Party Name:SIRMAXO CHEMICALS PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00307/AM17/ RLA File :03/95/040/00911/AM15/ Lic.No/Date:0310793837 12.02.2015 Defer Date: Decision :Already approved in Meeting No.13/82. 70 Case No.:91/7/82- ALC4/2015 Party Name:SHREE GANESH REMEDIES PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 71 Case No.:52/19/82- ALC4/2014 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01540/AM15/ RLA File :05/24/040/00273/AM15/ Lic.No/Date:0510393248 17.02.2015 Defer Date: 15.02.2017 Decision :Deferred. 72 Case No.:63/4/82-ALC4/2015 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00102/AM16/ RLA File :09/24/040/00649/AM15/ Lic.No/Date:0910061639 20.02.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/99/2015-PI(Norms) dated Sept. 2015, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 73 Case No.:62/4/82-ALC4/2015 Party Name:RAKSHIT PHARMACEUTICALS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00101/AM16/ RLA File :09/24/040/00644/AM15/ Lic.No/Date:0910061636 20.02.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/238/2015-PI(Norms) dated Sept. 2015, uploaded 74 Case No.:280/5/82- ALC4/2015 Party Name:FERMENTA BIOTECH LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File RLA File Lic.No/Date:0310794101 Defer Date:

:01/82/050/00420/AM16/ :03/94/040/01110/AM15/ 24.02.2015 15.02.2017 Decision : Information called for from the firm in NC meeting No.06/82 dated 14.05.2016 is awaited. The Committee accordingly deferred the case. 75 Case No.:54/4/82-ALC4/2015 Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00093/AM16/ RLA File :08/24/040/00427/AM15/ Lic.No/Date:0810134665 25.02.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/273/2015-PI(Norms) dated Sept. 2015, uploaded 76 Case No.:72/4/82- ALC4/2015 Party Name:LANTECH PHARMACEUTICALS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00111/AM16/ RLA File :09/24/040/00647/AM15/ Lic.No/Date:0910061664 04.03.2015 Defer Date: 15.02.2017 77 Case No.:85/4/82- ALC4/2015 LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00124/AM16/ RLA File :09/24/040/00684/AM15/ Lic.No/Date:0910061681 11.03.2015 Defer Date: 15.02.2017 Decision :Deferred. 78 Case No.:53/4/82-ALC4/2015 Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00092/AM16/ RLA File :08/24/040/00451/AM15/ Lic.No/Date:0810134799 13.03.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/241/2015-PI(Norms) dated Sept. 2015, uploaded 79 Case No.:56/4/82-ALC4/2015 Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00095/AM16/ RLA File :08/24/040/00450/AM15/ Lic.No/Date:0810134798 13.03.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/726/2015-PI(Norms) dated 28.04.2016, uploaded 80 Case No.:106/7/82- Party Name:ALCHEMIE Meet No/Date:16/82- Status:Deferred

ALC4/2015 LABORATORIES ALC4/2016 28.12.2016 HQ File :01/82/050/00711/AM16/ RLA File :03/94/040/00812/AM15/ Lic.No/Date:0310794612 16.03.2015 Defer Date: 15.02.2017 81 Case No.:48/4/82- ALC4/2015 Party Name:MAMTA POLYCOATS Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00087/AM16/ RLA File :34/24/040/00329/AM15/ Lic.No/Date:3410041054 17.03.2015 Defer Date: 15.02.2017 Decision :Deferred. 82 Case No.:46/4/82-ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00085/AM16/ RLA File :34/24/040/00334/AM15/ Lic.No/Date:3410041091 25.03.2015 Defer Date: taken by NC in its meeting No.26/82 dated 27.09.2011 , uploaded at the end of these minutes or 83 Case No.:21/4/82-ALC4/2015 SCIENCES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00060/AM16/ RLA File :05/23/040/00568/AM15/ Lic.No/Date:0510393736 25.03.2015 Defer Date: taken by NC in its meeting No.45/82 dated 07.02.2012 , uploaded at the end of these minutes or 84 Case No.:43/4/82-ALC4/2015 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00082/AM16/ RLA File :34/24/040/00350/AM15/ Lic.No/Date:3410041107 30.03.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/153/2014-PI(Norms) dated Oct. 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. 85 Case No.:30/4/82-ALC4/2015 Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00069/AM16/ RLA File :04/24/040/00306/AM15/ Lic.No/Date:0410160363 30.03.2015 Defer Date:

Pharmaceuticals forwarded vide O.M.No.35011/364/2015-PI(Norms) dated 30.11.2015, uploaded 86 Case No.:38/4/82-ALC4/2015 Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00077/AM16/ RLA File :04/24/040/00305/AM15/ Lic.No/Date:0410160362 30.03.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/364/2015-PI(Norms) dated 30.11.2015, uploaded 87 Case No.:65/4/82- ALC4/2015 Party Name:MYLAN Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00104/AM16/ RLA File :09/24/040/00662/AM15/ Lic.No/Date:0910061843 31.03.2015 Defer Date: 15.02.2017 Decision : Information has been received and forwarded to DoP for comments. 88 Case No.:36/4/82- ALC4/2015 Party Name:NUTRA SPECIALITIES PVT. LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00075/AM16/ RLA File :04/24/040/00298/AM15/ Lic.No/Date:0410160376 31.03.2015 Defer Date: 15.02.2017 Decision :Deferred for want of comments from DoP. 8 9 Case No.:78/4/82- ALC4/2015 Party Name:SMILAX LABORATORIES LIMI TED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferre d HQ File :01/82/050/00117/AM 16/ RLA File :09/24/040/00710/AM15/ Lic.No/Date:09100618 58 31.03.2015 Defer Date: 15.02.2017 90 Case No.:86/4/82- ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00125/AM16/ RLA File :09/24/040/00721/AM15/ Lic.No/Date:0910061812 31.03.2015 Defer Date: 15.02.2017 91 Case No.:64/4/82- ALC4/2015 LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00103/AM16/ RLA File :09/24/040/00595/AM15/ Lic.No/Date:0910061851 31.03.2015 Defer Date: 15.02.2017 Decision :Deferred.

92 Case No.:73/4/82- ALC4/2015 LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00112/AM16/ RLA File :09/24/040/00700/AM15/ Lic.No/Date:0910061821 31.03.2015 Defer Date: 15.02.2017 Decision :Deferred. 93 Case No.:52/4/82- ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00091/AM16/ RLA File :05/24/040/00562/AM15/ Lic.No/Date:0510393822 01.04.2015 Defer Date: 15.02.2017 Decision :Deferred. 94 Case No.:88/4/82- ALC4/2015 Party Name:INDO AMINES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00127/AM16/ RLA File :03/94/040/01218/AM15/ Lic.No/Date:0310795135 07.04.2015 Defer Date: 15.02.2017 Decision :Deferred. 95 Case No.:80/4/82- ALC4/2015 Party Name:VINS BIOPRODUCTS LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00119/AM16/ RLA File :09/24/040/00652/AM15/ Lic.No/Date:0910061882 15.04.2015 Defer Date: 15.02.2017 96 Case No.:5/2/82-ALC4/2015 Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00020/AM16/ RLA File :09/24/040/00689/AM15/ Lic.No/Date:0910061894 17.04.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/461/2015-PI(Norms) dated November 2015, 97 Case No.:67/4/82-ALC4/2015 Party Name:STERMONE CHEMICALS PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00106/AM16/ RLA File :34/24/040/00336/AM15/ Lic.No/Date:3410041147 17.04.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/868/2015-PI(Norms) dated 24.05.2016, uploaded

98 Case No.:76/4/82- ALC4/2015 LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00115/AM16/ RLA File :09/24/040/00717/AM15/ Lic.No/Date:0910061893 17.04.2015 Defer Date: 15.02.2017 Decision :Deferred. 99 Case No.:77/4/82- ALC4/2015 LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00116/AM16/ RLA File :09/24/040/00738/AM15/ Lic.No/Date:0910061892 17.04.2015 Defer Date: 15.02.2017 Decision :Deferred. 100 Case No.:6/2/82-ALC4/2015 Party Name:ALMELO PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00021/AM16/ RLA File :09/24/040/00001/AM16/ Lic.No/Date:0910061899 20.04.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/537/2015-PI(Norms) dated December 2015, 101 Case No.:66/4/82- ALC4/2015 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00105/AM16/ RLA File :34/24/040/00010/AM16/ Lic.No/Date:3410041157 22.04.2015 Defer Date: 15.02.2017 Decision :Deferred. 102 Case No.:69/4/82- ALC4/2015 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00108/AM16/ RLA File :34/24/040/00012/AM16/ Lic.No/Date:3410041158 22.04.2015 Defer Date: 15.02.2017 Decision :Deferred. 103 Case No.:84/4/82-ALC4/2015 Party Name:VENUS REMEDIES LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00123/AM16/ RLA File :22/24/040/00119/AM15/ Lic.No/Date:2210015225 23.04.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/767/2015-PI(Norms) dated June 2016, uploaded 104 Case No.:83/4/82- Party Name:CONTINENTAL Meet No/Date:16/82- Status:Deferred

ALC4/2015 CHEMICALS ALC4/2016 28.12.2016 HQ File :01/82/050/00122/AM16/ RLA File :08/24/040/00005/AM16/ Lic.No/Date:0810135094 24.04.2015 Defer Date: 15.02.2017 Decision :Deferred. 105 Case No.:71/4/82-ALC4/2015 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00110/AM16/ RLA File :34/24/040/00025/AM16/ Lic.No/Date:3410041192 29.04.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/305/2015-PI(Norms) dated Oct. 2015, uploaded 106 Case No.:50/7/82-ALC4/2015 Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00655/AM16/ RLA File :09/24/040/00041/AM16/ Lic.No/Date:0910061976 06.05.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/715/2013-PI(Norms) dated Sept. 2014, uploaded 107 Case No.:15/7/82- ALC4/2015 Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 108 Case No.:129/7/82- ALC4/2015 Party Name:NATIONAL TUBE INDUSTRIES, Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision : Deferred for want of comments from MSME. 109 Case No.:102/7/82- ALC4/2015 Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00707/AM16/ RLA File :30/24/040/00006/AM16/ Lic.No/Date:3010103498 21.05.2015 Defer Date: 15.02.2017 Decision :Deferred. 110 Case No.:55/13/82- ALC4/2015 Party Name:GLOBAL CALCIUM PRIVATE Meet No/Date:16/82- ALC4/2016 Status:Deferred

LIMITED, 28.12.2016 HQ File :01/82/050/01018/AM16/ RLA File :07/24/040/00036/AM16/ Lic.No/Date:0710108251 22.05.2015 Defer Date: 15.02.2017 Decision :Deferred. 111 Case No.:8/4/82-ALC4/2015 Party Name:INCHEM LABORATORIES PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00047/AM16/ RLA File :09/24/040/00048/AM16/ Lic.No/Date:0910062074 26.05.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/105/2015-PI(Norms) dated Oct. 2015, uploaded 112 Case No.:124/7/82-ALC4/2015 Party Name:PRIVI ORGANICS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00729/AM16/ RLA File :03/95/040/00114/AM16/ Lic.No/Date:0310796233 27.05.2015 Defer Date: taken by NC in its meeting No.21/82 dated 23.08.2011, uploaded at the end of these minutes or 113 Case No.:92/4/82-ALC4/2015 Party Name:ALMELO PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00131/AM16/ RLA File :09/24/040/00115/AM16/ Lic.No/Date:0910062107 01.06.2015 Defer Date: Approved Pharmaceuticals forwarded vide O.M.No.35011/537/2015-PI(Norms) dated December 2015, 114 Case No.:94/4/82-ALC4/2015 Party Name:ALMELO PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00133/AM16/ RLA File :09/24/040/00113/AM16/ Lic.No/Date:0910062119 02.06.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/537/2015-PI(Norms) dated December 2015, 115 Case No.:95/4/82-ALC4/2015 Party Name:ALMELO PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00134/AM16/ RLA File :09/24/040/00114/AM16/ Lic.No/Date:0910062120 02.06.2015 Defer Date:

Pharmaceuticals forwarded vide O.M.No.35011/537/2015-PI(Norms) dated December 2015, 116 Case No.:8/16/82-ALC4/2016 Party Name:SOHAN HEALTHCARE PVT. LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00825/AM17/ RLA File :31/83/040/00010/AM16/ Lic.No/Date:3110065459 02.06.2015 Defer Date: taken by NC in its meeting No.20/82 dated 20.09.2012, uploaded at the end of these minutes or 117 Case No.:99/4/82- ALC4/2015 Party Name:INTAS PHARMACEUTICALS LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00138/AM16/ RLA File :08/24/040/00072/AM16/ Lic.No/Date:0810135427 03.06.2015 Defer Date: 15.02.2017 Decision : The representative of D/o Pharmaceuticals stated in the meeting that DML and master Batch Formula is required for ratification of norms. The Committee accordingly decided to call for copy of DML and Master Batch Formula from the firm and deferred the case. 118 Case No.:110/7/82- ALC4/2015 Party Name:RISHABH METALS & CHEMICALS PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 119 Case No.:17/7/82- ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00622/AM16/ RLA File :05/24/040/00078/AM16/ Lic.No/Date:0510394418 03.06.2015 Defer Date: 15.02.2017 Decision : Information called for from the firm in NC meeting No,04/82 dated 24.05.2016 is awaited. The Committee accordingly defer the case. 120 Case No.:67/7/82-ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Rejected. HQ File :01/82/050/00672/AM16/ RLA File :09/24/040/00105/AM16/ Lic.No/Date:0910062138 05.06.2015 Defer Date: Decision : The Committee noted that Information called for from the firm in NC meeting No,21/82 dated 22.03.2016 has not furnished by firm. 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.

121 Case No.:60/4/82- ALC4/2016 Party Name:ADCOCK INGRAM LTD, Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision : Information called for from the firm in NC meeting No,12/82 dated 28.09.2016 is awaited. The Committee accordingly defer the case. 122 Case No.:66/7/82- ALC4/2015 LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 123 Case No.:159/7/82- ALC4/2015 Party Name:VIJAY PERFUMES PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00764/AM16/ RLA File :03/95/040/00985/AM15/ Lic.No/Date:0310796576 11.06.2015 Defer Date: 15.02.2017 Decision :Deferred. 124 Case No.:42/13/82- ALC4/2015 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision : Information called for from the firm in NC meeting No.12 dated 28.09.2016 is awaited. The Committee accordingly deferred the case. 125 Case No.:48/19/82- ALC4/2015 Party Name:RAJ DHANVANTRY PHARMACY Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 126 Case No.:41/13/82- ALC4/2015 Party Name:DANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01004/AM16/ RLA File :03/94/040/00111/AM16/ Lic.No/Date:0310796667 16.06.2015 Defer Date: 15.02.2017 Decision :Deferred. 127 Case No.:52/7/82- ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File RLA File Lic.No/Date:0510394590 Defer Date:

:01/82/050/00657/AM16/ :05/23/040/00107/AM16/ 17.06.2015 15.02.2017 Decision : Information called for from the firm in NC meeting No.14 dated 29.11.2016 is awaited. The Committee accordingly deferred the case. 128 Case No.:43/13/82- ALC4/2015 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01006/AM16/ RLA File :03/94/040/00178/AM16/ Lic.No/Date:0310796712 18.06.2015 Defer Date: 15.02.2017 Decision : Information called for from the firm in NC meeting No.12 dated 28.09.2016 is awaited. The Committee accordingly deferred the case. 129 Case No.:15/9/82-ALC4/2015 Party Name:KDAC CHEM PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00951/AM16/ RLA File :34/24/040/00069/AM16/ Lic.No/Date:3410041310 22.06.2015 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on .the earlier decision taken by NC in its meeting No.26/82 dated 28.09.2010, uploaded at the end of these minutes or 130 Case No.:83/13/82- ALC4/2015 Party Name:RIDDHI PHARMA Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 131 Case No.:75/7/82- ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 132 Case No.:108/14/82- ALC4/2015 LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 133 Case No.:10/13/82- ALC4/2015 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00973/AM16/ RLA File :03/94/040/00229/AM16/ Lic.No/Date:0310797018 02.07.2015 Defer Date: 15.02.2017

Decision :Deferred. 134 Case No.:11/13/82- ALC4/2015 Party Name:AMINES & Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 135 Case No.:24/13/82- ALC4/2015 Party Name:DANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 136 Case No.:20/16/82- ALC4/2015 Party Name:MYLAN Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01340/AM16/ RLA File :09/24/040/00032/AM16/ Lic.No/Date:0910062338 15.07.2015 Defer Date: 15.02.2017 Decision :Deferred for want of comments from DoP. 137 Case No.:22/13/82- ALC4/2015 Party Name:BLISS INDASI LIFESCIENCES PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00985/AM16/ RLA File :03/94/040/00282/AM16/ Lic.No/Date:0310797355 17.07.2015 Defer Date: 15.02.2017 Decision : Information called for from the firm in NC meeting No,02/82 dated 2.04.2016 is awaited. The Committee accordingly defer the case. 138 Case No.:115/13/82- ALC4/2015 Party Name:FERMENTA BIOTECH LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01078/AM16/ RLA File :03/94/040/00038/AM16/ Lic.No/Date:0310797627 24.07.2015 Defer Date: 15.02.2017 139 Case No.:73/8/82- ALC4/2015 Party Name:RECKITT BENCKISER HEALTHCARE INDIA LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision : Information called for from the firm in NC meeting No,06/82 dated 14.06.2016 is awaited. The Committee accordingly defer the case. 140 Case No.:116/13/82- Party Name:JINDAL DRUGS Meet No/Date:16/82- Status:Deferred

ALC4/2015 PRIVATE LIMITED ALC4/2016 28.12.2016 HQ File :01/82/050/01079/AM16/ RLA File :03/94/040/00215/AM16/ Lic.No/Date:0310797864 31.07.2015 Defer Date: 15.02.2017 Decision :Deferred. 141 Case No.:112/13/82- ALC4/2015 Party Name:K V AROCHEM PVT. LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 142 Case No.:109/13/82- ALC4/2015 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01072/AM16/ RLA File :03/94/040/00170/AM16/ Lic.No/Date:0310797954 05.08.2015 Defer Date: 15.02.2017 Decision : The Committee noted that information called for from the firm in NC meeting No.6/82 dated 14.06.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 143 Case No.:12/18/82- ALC4/2015 Party Name:OMTECH CHEMICAL INDUSTRIES PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 144 Case No.:50/13/82- ALC4/2015 Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01013/AM16/ RLA File :04/24/040/00095/AM16/ Lic.No/Date:0410160884 06.08.2015 Defer Date: 15.02.2017 Decision :Deferred. 145 Case No.:111/13/82- ALC4/2015 Party Name:HEMA DYE CHEM PVT. LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01074/AM16/ RLA File :03/94/040/00305/AM16/ Lic.No/Date:0310798134 13.08.2015 Defer Date: 15.02.2017 Decision :Deferred. 146 Case No.:79/13/82- ALC4/2015 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01042/AM16/ RLA File :52/24/040/00034/AM16/ Lic.No/Date:5210041610 14.08.2015 Defer Date: 15.02.2017

Decision :Deferred. 147 Case No.:127/13/82- ALC4/2015 Party Name:ASTEC LIFESCIENCES LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01090/AM16/ RLA File :03/94/040/00878/AM15/ Lic.No/Date:0310798205 17.08.2015 Defer Date: 15.02.2017 148 Case No.:126/13/82- ALC4/2015 Party Name:ASTEC LIFESCIENCES LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01089/AM16/ RLA File :03/94/040/00879/AM15/ Lic.No/Date:0310798319 20.08.2015 Defer Date: 15.02.2017 149 Case No.:61/13/82- ALC4/2015 PVT.LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01024/AM16/ RLA File :05/23/040/00218/AM16/ Lic.No/Date:0510395388 20.08.2015 Defer Date: 15.02.2017 Decision : Information called for from the firm in NC 08/82 dated 27.07.2016 is awaited. The Committee accordingly deferred the case. 150 Case No.:161/13/82- ALC4/2015 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 151 Case No.:77/13/82- ALC4/2015 Party Name:ARKRAY HEALTHCARE PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision : : Information called for from the firm in NC 10/82 dated 23.08.2016 is awaited. The Committee accordingly deferred the case. 152 Case No.:84/14/82-ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/01220/AM16/ RLA File :05/24/040/00262/AM16/ Lic.No/Date:0510395506 03.09.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/316/2014-PI(Norms) dated December 2014,

153 Case No.:59/11/82- ALC4/2016 PVT LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00593/AM17/ RLA File :52/24/040/00040/AM16/ Lic.No/Date:5210041626 04.09.2015 Defer Date: 15.02.2017 Decision :Deferred. 154 Case No.:5/18/82- ALC4/2015 PVT LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01470/AM16/ RLA File :52/24/040/00039/AM16/ Lic.No/Date:5210041625 04.09.2015 Defer Date: 15.02.2017 Decision :Deferred. 155 Case No.:59/4/82- ALC4/2016 Party Name:ADCOCK INGRAM LTD, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00122/AM17/ RLA File :07/24/040/00180/AM16/ Lic.No/Date:0710108694 07.09.2015 Defer Date: 15.02.2017 Decision : The Committee noted that information called for from the firm in NC meeting No.12/82 dated 28.09.2016 is awaited. The Committee accordingly deferred the case. 156 Case No.:8/16/82- ALC4/2015 LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 157 Case No.:12/19/82- ALC4/2015 Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01492/AM16/ RLA File :04/24/040/00154/AM16/ Lic.No/Date:0410161070 01.10.2015 Defer Date: 15.02.2017 Decision :Deferred. 158 Case No.:44/4/82-ALC4/2016 Party Name:KUBO COMBUSTION EFFICIENCY CHEMICALS PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00107/AM17/ RLA File :03/94/040/00468/AM16/ Lic.No/Date:0310799183 05.10.2015 Defer Date: taken by NC in its meeting No.01/82 dated 04.04.2013, uploaded at the end of these minutes or 159 Case No.:133/16/82- Party Name:GLOBAL Meet No/Date:16/82- Status:

ALC4/2016 CALCIUM PRIVATE LIMITED, ALC4/2016 28.12.2016 Approved HQ File :01/82/050/00950/AM17/ RLA File :07/24/040/00113/AM16/ Lic.No/Date:0710108860 08.10.2015 Defer Date: taken by NC in its meeting No.08/82 dated 25.09.2014 , uploaded at the end of these minutes or 160 Case No.:130/14/82- ALC4/2015 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01266/AM16/ RLA File :05/24/040/00317/AM16/ Lic.No/Date:0510395874 09.10.2015 Defer Date: 15.02.2017 Decision :Deferred. 161 Case No.:144/14/82- ALC4/2015 PVT LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01280/AM16/ RLA File :52/24/040/00049/AM16/ Lic.No/Date:5210041658 14.10.2015 Defer Date: 15.02.2017 Decision :Deferred. 162 Case No.:135/13/82- ALC4/2015 Party Name:MYLAN Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred for want of comments from DoP. 163 Case No.:24/16/82- ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01344/AM16/ RLA File :09/24/040/00380/AM16/ Lic.No/Date:0910062727 14.10.2015 Defer Date: 15.02.2017 Decision :Deferred. 164 Case No.:136/13/82- ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01099/AM16/ RLA File :08/24/040/00207/AM16/ Lic.No/Date:0810136320 16.10.2015 Defer Date: 15.02.2017 Decision :Deferred. 165 Case No.:77/16/82- ALC4/2015 Party Name:LACTOSE (INDIA) LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File RLA File Lic.No/Date:0310799561 Defer Date:

:01/82/050/01397/AM16/ :03/95/040/00481/AM16/ 20.10.2015 15.02.2017 Decision : Information called for from the firm in NC meeting No.08/82 dated 27.07.2016 is awaited. The Committee accordingly deferred the case. 166 Case No.:140/13/82- ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 167 Case No.:141/13/82- ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01104/AM16/ RLA File :03/95/040/00504/AM16/ Lic.No/Date:0310799629 23.10.2015 Defer Date: 15.02.2017 Decision :Deferred. 168 Case No.:132/16/82- ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00949/AM17/ RLA File :07/24/040/00117/AM16/ Lic.No/Date:0710108957 27.10.2015 Defer Date: taken by NC in its meeting No.06/82 dated 29.08.2014 , uploaded at the end of these minutes or 169 Case No.:142/13/82- ALC4/2015 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01105/AM16/ RLA File :09/24/040/00443/AM16/ Lic.No/Date:0910062774 27.10.2015 Defer Date: 15.02.2017 Decision :Deferred. 170 Case No.:147/13/82- ALC4/2015 Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01110/AM16/ RLA File :08/24/040/00241/AM16/ Lic.No/Date:0810136382 29.10.2015 Defer Date: 15.02.2017 Decision :Deferred. 171 Case No.:64/19/82- ALC4/2015 Party Name:INDO AMINES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01545/AM16/ RLA File :03/94/040/00240/AM16/ Lic.No/Date:0310799907 30.10.2015 Defer Date: 15.02.2017 Decision :Deferred.

172 Case No.:65/19/82- ALC4/2015 Party Name:INDO AMINES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 173 Case No.:66/19/82- ALC4/2015 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01547/AM16/ RLA File :03/94/040/00582/AM16/ Lic.No/Date:0310799943 02.11.2015 Defer Date: 15.02.2017 Decision :Deferred. 174 Case No.:38/21/82- ALC4/2015 Party Name:VINS BIOPRODUCTS LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01743/AM16/ RLA File :09/24/040/00442/AM16/ Lic.No/Date:0910062831 03.11.2015 Defer Date: 15.02.2017 Decision :Deferred for want of comments from DBT. 175 Case No.:159/13/82- ALC4/2015 Party Name:CHEMCON SPECIALITY CHEMICALS P LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01122/AM16/ RLA File :34/24/040/00205/AM16/ Lic.No/Date:3410041650 04.11.2015 Defer Date: 15.02.2017 Decision :Deferred. 176 Case No.:57/19/82- ALC4/2015 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01538/AM16/ RLA File :03/94/040/00443/AM16/ Lic.No/Date:0310800060 05.11.2015 Defer Date: 15.02.2017 Decision :Deferred. 177 Case No.:138/16/82- ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00955/AM17/ RLA File :07/24/040/00254/AM16/ Lic.No/Date:0710109007 05.11.2015 Defer Date: taken by NC in its meeting No.08/82 dated 25.09.2014 , uploaded at the end of these minutes or 178 Case No.:18/21/82- ALC4/2015 Party Name:BHAGIRADHA CHEMICALS & Meet No/Date:16/82- ALC4/2016 Status:Deferred

INDUSTRIES LIMITED 28.12.2016 HQ File :01/82/050/01723/AM16/ RLA File :09/24/040/00487/AM16/ Lic.No/Date:0910062841 06.11.2015 Defer Date: 15.02.2017 Decision :Deferred. 179 Case No.:2/16/82- ALC4/2015 Party Name:SANO MEDICAL KITS PVT. LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01322/AM16/ RLA File :04/24/040/00175/AM16/ Lic.No/Date:0410161296 09.11.2015 Defer Date: 15.02.2017 Decision : 180 Case No.:23/21/82-ALC4/2015 Party Name:OPTIMUS Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Rejected HQ File :01/82/050/01728/AM16/ RLA File :09/24/040/00481/AM16/ Lic.No/Date:0910062849 10.11.2015 Defer Date: Decision : The Committee noted that information called for from the firm in NC meeting No.06/82 dated 14.06.2016 has not been furnished. In absence of these information norms cannot be decided. The Committee accordingly decided to reject the case. RA concerned may taken further necessary action as per the decision of NC. 181 Case No.:165/13/82- ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 182 Case No.:71/19/82- ALC4/2015 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01552/AM16/ RLA File :03/94/040/00613/AM16/ Lic.No/Date:0310800272 17.11.2015 Defer Date: 15.02.2017 Decision :Deferred. 183 Case No.:72/19/82- ALC4/2015 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 184 Case No.:58/19/82- ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01539/AM16/ RLA File :03/94/040/00572/AM16/ Lic.No/Date:0310800324 19.11.2015 Defer Date: 15.02.2017

Decision :Deferred. 185 Case No.:75/19/82-ALC4/2015 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/01556/AM16/ RLA File :03/94/040/00450/AM16/ Lic.No/Date:0310800347 20.11.2015 Defer Date: taken by NC in its meeting No.18/82 dated 19.12.2013, uploaded at the end of these minutes or 186 Case No.:60/19/82- ALC4/2015 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01541/AM16/ RLA File :03/94/040/00661/AM16/ Lic.No/Date:0310800340 20.11.2015 Defer Date: 15.02.2017 Decision :Deferred. 187 Case No.:20/19/82- ALC4/2015 Party Name:VDH CHEM TECH PVT. LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 188 Case No.:59/19/82- ALC4/2015 Party Name:EXCEL INDUSTRIES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 189 Case No.:62/19/82- ALC4/2015 Party Name:EXCEL INDUSTRIES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01543/AM16/ RLA File :03/94/040/00252/AM16/ Lic.No/Date:0310800539 01.12.2015 Defer Date: 15.02.2017 Decision :Deferred. 190 Case No.:61/19/82- ALC4/2015 Party Name:K V AROCHEM PVT. LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 191 Case No.:17/19/82- Party Name:JUBILANT LIFE Meet No/Date:16/82- Status:Deferred

ALC4/2015 SCIENCES LIMITED ALC4/2016 28.12.2016 HQ File :01/82/050/01497/AM16/ RLA File :05/23/040/00002/AM16/ Lic.No/Date:0510396500 03.12.2015 Defer Date: 15.02.2017 Decision :Deferred. 192 Case No.:38/19/82- ALC4/2015 PVT LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01519/AM16/ RLA File :52/24/040/00062/AM16/ Lic.No/Date:5210041707 04.12.2015 Defer Date: 15.02.2017 Decision :Deferred. 193 Case No.:1/8/82-ALC4/2016 Party Name:SWATI MENTHOL & ALLIED CHEMICALS LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00339/AM17/ RLA File :29/24/040/00007/AM16/ Lic.No/Date:2910025232 04.12.2015 Defer Date: 15.02.2017 Decision :Deferred. 194 Case No.:90/19/82- ALC4/2015 Party Name:VENUS REMEDIES LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred for want of comments from DoP. 195 Case No.:40/19/82- ALC4/2015 SCIENCES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 196 Case No.:88/19/82- ALC4/2015 Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01569/AM16/ RLA File :22/24/040/00081/AM16/ Lic.No/Date:2210015365 10.12.2015 Defer Date: 15.02.2017 Decision :Deferred. 197 Case No.:56/21/82- ALC4/2015 LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred.

198 Case No.:30/19/82- ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred 199 Case No.:31/19/82- ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01511/AM16/ RLA File :05/24/040/00375/AM16/ Lic.No/Date:0510396609 14.12.2015 Defer Date: 15.02.2017 Decision :Deferred. 200 Case No.:32/19/82- ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 201 Case No.:10/19/82-ALC4/2015 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/01490/AM16/ RLA File :34/24/040/00223/AM16/ Lic.No/Date:3410041732 14.12.2015 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.26/82 dated 27.09.2011, uploaded at the end of these minutes or as 202 Case No.:18/19/82- ALC4/2015 PVT LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01498/AM16/ RLA File :52/24/040/00064/AM16/ Lic.No/Date:5210041711 15.12.2015 Defer Date: 15.02.2017 Decision :Deferred. 203 Case No.:39/19/82- ALC4/2015 SCIENCES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 204 Case No.:41/19/82- ALC4/2015 SCIENCES LIMITED Meet No/Date:16/82- ALC4/2016 Status:Deferred

28.12.2016 HQ File :01/82/050/01522/AM16/ RLA File :05/23/040/00001/AM16/ Lic.No/Date:0510396632 16.12.2015 Defer Date: 15.02.2017 Decision :Deferred. 205 Case No.:42/19/82- ALC4/2015 SCIENCES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01523/AM16/ RLA File :05/23/040/00192/AM16/ Lic.No/Date:0510396633 16.12.2015 Defer Date: 15.02.2017 Decision :Deferred. 206 Case No.:36/19/82- ALC4/2015 Party Name:PANACEA BIOTEC LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01517/AM16/ RLA File :05/24/040/00439/AM16/ Lic.No/Date:0510396670 18.12.2015 Defer Date: 15.02.2017 Decision : Deferred for want of comments from DBT. 207 Case No.:35/19/82- ALC4/2015 Party Name:HELLO PAINTS (P) LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01516/AM16/ RLA File :05/23/040/00396/AM16/ Lic.No/Date:0510396751 21.12.2015 Defer Date: 15.02.2017 Decision :Deferred. 208 Case No.:33/19/82- ALC4/2015 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01514/AM16/ RLA File :05/24/040/00448/AM16/ Lic.No/Date:0510396777 21.12.2015 Defer Date: 15.02.2017 Decision :Deferred. 209 Case No.:54/21/82- ALC4/2015 LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01759/AM16/ RLA File :09/24/040/00525/AM16/ Lic.No/Date:0910063015 21.12.2015 Defer Date: 15.02.2017 Decision :Deferred. 210 Case No.:61/21/82- ALC4/2015 LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01766/AM16/ RLA File :09/24/040/00547/AM16/ Lic.No/Date:0910063018 21.12.2015 Defer Date: 15.02.2017 Decision :Deferred.

211 Case No.:55/21/82-ALC4/2015 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/01760/AM16/ RLA File :09/24/040/00573/AM16/ Lic.No/Date:0910063035 28.12.2015 Defer Date: taken by NC in its meeting No.07/82 dated 11.09.2014 , uploaded at the end of these minutes or 212 Case No.:34/21/82-ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/01739/AM16/ RLA File :31/83/040/00128/AM16/ Lic.No/Date:3110065816 30.12.2015 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.12/82 dated 15.12.2014, uploaded at the end of these minutes or as 213 Case No.:22/19/82- ALC4/2015 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01502/AM16/ RLA File :05/23/040/00244/AM16/ Lic.No/Date:0510397137 30.12.2015 Defer Date: 15.02.2017 Decision : Information called for from the firm in NC meeting No.06/82 dated 14.06.2016 is awaited. 214 Case No.:23/19/82- ALC4/2015 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01503/AM16/ RLA File :05/23/040/00260/AM16/ Lic.No/Date:0510397138 30.12.2015 Defer Date: 15.02.2017 Decision : Information called for from the firm in NC meeting No.06/82 dated 14.06.2016 is awaited. 215 Case No.:13/19/82- ALC4/2015 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision : Information called for from the firm in NC meeting No.04/82 dated 24.05.2016 is awaited. 216 Case No.:47/21/82- ALC4/2015 Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File RLA File Lic.No/Date:0910063087 Defer Date:

:01/82/050/01752/AM16/ :09/24/040/00570/AM16/ 01.01.2016 15.02.2017 Decision :Deferred. 217 Case No.:35/21/82- ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01740/AM16/ RLA File :31/83/040/00094/AM16/ Lic.No/Date:3110065843 01.01.2016 Defer Date: 15.02.2017 Decision :Deferred. 218 Case No.:2/17/82- ALC4/2015 Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01462/AM16/ RLA File :09/24/040/00571/AM16/ Lic.No/Date:0910063114 08.01.2016 Defer Date: 15.02.2017 Decision : Information called for from the firm in NC meeting No.12/82 dated 28.09.2016 is awaited. 219 Case No.:5/17/82- ALC4/2015 Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01465/AM16/ RLA File :30/24/040/00035/AM16/ Lic.No/Date:3010103695 11.01.2016 Defer Date: 15.02.2017 Decision :Deferred. 220 Case No.:60/21/82- ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01765/AM16/ RLA File :09/24/040/00581/AM16/ Lic.No/Date:0910063135 13.01.2016 Defer Date: 15.02.2017 Decision :Deferred. 221 Case No.:37/2/82- ALC4/2016 Party Name:ALKALOIDS CORPORATION Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00037/AM17/ RLA File :02/24/040/00181/AM16/ Lic.No/Date:0210206452 19.01.2016 Defer Date: 15.02.2017 Decision : Information called for from the firm in NC meeting No.12/82 dated 28.09.2016 is awaited. 222 Case No.:67/1/82-ALC1/2016 Party Name:INDOCO REMEDIES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/01841/AM16/ RLA File :03/94/040/00880/AM16/ Lic.No/Date:0310802014 22.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/29/2016-PI(Norms) dated 19.12.2016, uploaded

223 Case No.:24/21/82- ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01729/AM16/ RLA File :34/24/040/00267/AM16/ Lic.No/Date:3410041832 28.01.2016 Defer Date: 15.02.2017 Decision :Deferred. 224 Case No.:17/10/82- ALC4/2016 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00363/AM17/ RLA File :22/24/040/00104/AM16/ Lic.No/Date:2210015407 01.02.2016 Defer Date: 15.02.2017 225 Case No.:8/21/82- ALC4/2015 Party Name:JUBILANT GENERICS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01713/AM16/ RLA File :05/23/040/00438/AM16/ Lic.No/Date:0510397455 01.02.2016 Defer Date: 15.02.2017 Decision :Deferred. 226 Case No.:13/21/82- ALC4/2015 SCIENCES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 227 Case No.:1/19/82- ALC4/2015 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01481/AM16/ RLA File :09/24/040/00634/AM16/ Lic.No/Date:0910063213 04.02.2016 Defer Date: 15.02.2017 Decision :Deferred for want of comments from DoP. 228 Case No.:4/19/82- ALC4/2015 Party Name:ALPHAMED FORMULATIONS P LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01484/AM16/ RLA File :09/24/040/00628/AM16/ Lic.No/Date:0910063226 05.02.2016 Defer Date: 15.02.2017 Decision : Information called for from the firm in NC meeting No.08/82 dated 27.07.2016 is awaited. 229 Case No.:25/21/82- ALC4/2015 Party Name:RONAK CHEMICALS Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred

HQ File :01/82/050/01730/AM16/ RLA File :34/24/040/00274/AM16/ Lic.No/Date:3410041858 05.02.2016 Defer Date: 15.02.2017 Decision : Deferred for want of comments from DoP 230 Case No.:26/21/82- ALC4/2015 Party Name:RONAK CHEMICALS Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01731/AM16/ RLA File :34/24/040/00273/AM16/ Lic.No/Date:3410041857 05.02.2016 Defer Date: 15.02.2017 Decision : Deferred for want of comments from DoP 231 Case No.:14/21/82- ALC4/2015 Party Name:DHAMPUR SUGAR MILLS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01719/AM16/ RLA File :05/23/040/00456/AM16/ Lic.No/Date:0510397521 08.02.2016 Defer Date: 15.02.2017 Decision :Deferred. 232 Case No.:5/19/82- ALC4/2015 Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01485/AM16/ RLA File :08/24/040/00291/AM16/ Lic.No/Date:0810137155 08.02.2016 Defer Date: 15.02.2017 Decision : Deferred 233 Case No.:62/4/82- ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00125/AM17/ RLA File :03/95/040/00568/AM16/ Lic.No/Date:0310802284 08.02.2016 Defer Date: 15.02.2017 Decision :Deferred. 234 Case No.:85/19/82- ALC4/2015 Party Name:ANUPAM RASAYAN (INDIA) LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01566/AM16/ RLA File :52/24/040/00076/AM16/ Lic.No/Date:5210041759 09.02.2016 Defer Date: 15.02.2017 235 Case No.:8/2/82-ALC4/2016 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00008/AM17/ RLA File :34/24/040/00284/AM16/ Lic.No/Date:3410041870 10.02.2016 Defer Date: 15.02.2017 Decision :Deferred. 236 Case No.:15/10/82- Party Name:INFINITY Meet No/Date:16/82- Status:Deferred

ALC4/2016 LABORATORIES PVT.LTD., ALC4/2016 28.12.2016 HQ File :01/82/050/00361/AM17/ RLA File :22/24/040/00107/AM16/ Lic.No/Date:2210015412 10.02.2016 Defer Date: 15.02.2017 237 Case No.:30/21/82- ALC4/2015 PVT.LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 238 Case No.:36/2/82- ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00036/AM17/ RLA File :03/95/040/00870/AM16/ Lic.No/Date:0310802475 11.02.2016 Defer Date: 15.02.2017 Decision :Deferred. 239 Case No.:5/2/82-ALC4/2016 Party Name:MAMTA POLYCOATS Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 240 Case No.:13/10/82- ALC4/2016 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00359/AM17/ RLA File :22/24/040/00109/AM16/ Lic.No/Date:2210015417 17.02.2016 Defer Date: 15.02.2017 241 Case No.:55/2/82- ALC4/2016 Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision : Information called for from the firm in NC meeting No.08/82 dated 27.07.2016 is awaited. The Committee accordingly deferred the case. 242 Case No.:35/2/82- ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00035/AM17/ RLA File :03/95/040/00868/AM16/ Lic.No/Date:0310802660 17.02.2016 Defer Date: 15.02.2017 Decision :Deferred.

243 Case No.:102/19/82- ALC4/2015 LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/01583/AM16/ RLA File :09/24/040/00666/AM16/ Lic.No/Date:0910063280 17.02.2016 Defer Date: 15.02.2017 Decision :Deferred. 244 Case No.:20/4/82- ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00083/AM17/ RLA File :05/23/040/00469/AM16/ Lic.No/Date:0510397644 18.02.2016 Defer Date: 15.02.2017 Decision :Deferred. 245 Case No.:23/4/82- ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00086/AM17/ RLA File :05/23/040/00470/AM16/ Lic.No/Date:0510397643 18.02.2016 Defer Date: 15.02.2017 Decision :Deferred. 246 Case No.:34/2/82- ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 247 Case No.:136/16/82- ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Approved HQ File :01/82/050/00953/AM17/ RLA File :07/24/040/00383/AM16/ Lic.No/Date:0710109434 23.02.2016 Defer Date: taken by NC in its meeting No.08/82 dated 25.09.2014 , uploaded at the end of these minutes or 248 Case No.:27/2/82-ALC4/2016 Party Name:PRIVI ORGANICS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00027/AM17/ RLA File :03/95/040/00874/AM16/ Lic.No/Date:0310802827 24.02.2016 Defer Date: taken by NC in its meeting No.21/82 dated 23.08.2011, uploaded at the end of these minutes or

249 Case No.:22/2/82-ALC4/2016 Party Name:SANJIVANI PARANTERAL LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00022/AM17/ RLA File :03/95/040/00897/AM16/ Lic.No/Date:0310802826 24.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/80/2016-PI(Norms) dated 19.12.2016, uploaded 250 Case No.:18/4/82- ALC4/2016 Party Name:z CHEM TECH PVT. LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00081/AM17/ RLA File :05/24/040/00550/AM16/ Lic.No/Date:0510397711 24.02.2016 Defer Date: 15.02.2017 Decision :Deferred. 251 Case No.:24/4/82- ALC4/2016 SCIENCES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00087/AM17/ RLA File :05/23/040/00491/AM16/ Lic.No/Date:0510397731 26.02.2016 Defer Date: 15.02.2017 Decision :Deferred. 252 Case No.:4/2/82-ALC4/2016 Party Name:RIDDHI PHARMA Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00004/AM17/ RLA File :34/24/040/00301/AM16/ Lic.No/Date:3410041924 26.02.2016 Defer Date: 15.02.2017 Decision :Deferred. 253 Case No.:84/4/82- ALC4/2016 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 254 Case No.:43/2/82-ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00043/AM17/ RLA File :03/95/040/00948/AM16/ Lic.No/Date:0310802906 29.02.2016 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.03/82 dated 17.04.2012, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 255 Case No.:6/2/82-ALC4/2016 Party Name:BEST VALUE Meet No/Date:16/82- Status:Deferred

CHEM PVT. LTD. ALC4/2016 28.12.2016 HQ File :01/82/050/00006/AM17/ RLA File :34/24/040/00308/AM16/ Lic.No/Date:3410041932 01.03.2016 Defer Date: 15.02.2017 Decision :Deferred. 256 Case No.:42/2/82- ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 257 Case No.:14/2/82- ALC4/2016 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00014/AM17/ RLA File :34/24/040/00221/AM16/ Lic.No/Date:3410041935 01.03.2016 Defer Date: 15.02.2017 Decision :Deferred. 258 Case No.:28/4/82- ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00091/AM17/ RLA File :03/94/040/00959/AM16/ Lic.No/Date:0310803032 03.03.2016 Defer Date: 15.02.2017 Decision :Deferred. 259 Case No.:67/7/82- ALC4/2016 Party Name:BIOLOGICAL E LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00241/AM17/ RLA File :09/24/040/00714/AM16/ Lic.No/Date:0910063353 03.03.2016 Defer Date: 15.02.2017 Decision :Deferred for want of comments from DoP. 260 Case No.:50/2/82- ALC4/2016 Party Name:PANERA BIOTEC PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision : Deferred for want of comments from DBT. 261 Case No.:66/4/82- ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00129/AM17/ RLA File :04/24/040/00257/AM16/ Lic.No/Date:0410161685 04.03.2016 Defer Date: 15.02.2017 Decision : Information called for from the firm in NC meeting No.12/82 dated 28.09.2016 is awaited. The Committee accordingly deferred the case.

262 Case No.:67/4/82- ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision : : Information called for from the firm in NC meeting No.12/82 dated 28.09.2016 is awaited. The Committee accordingly deferred the case 263 Case No.:40/4/82- ALC4/2016 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00103/AM17/ RLA File :03/94/040/01017/AM16/ Lic.No/Date:0310803105 07.03.2016 Defer Date: 15.02.2017 Decision :The Committee noted that information was called for from the firm in NC meeting No.14/82 dated 29.11.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 264 Case No.:41/4/82- ALC4/2016 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00104/AM17/ RLA File :03/94/040/01018/AM16/ Lic.No/Date:0310803103 07.03.2016 Defer Date: 15.02.2017 Decision : The Committee noted that information was called for from the firm in NC meeting No.14/82 dated 29.11.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 265 Case No.:57/4/82- ALC4/2016 Party Name:CLARIANT INDIA LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00120/AM17/ RLA File :03/94/040/01041/AM16/ Lic.No/Date:0310803137 08.03.2016 Defer Date: 15.02.2017 Decision : 266 Case No.:7/2/82-ALC4/2016 Party Name:SONGWON SPECIALTY CHEMICALS INDIA PVT. LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00007/AM17/ RLA File :34/24/040/00323/AM16/ Lic.No/Date:3410041954 08.03.2016 Defer Date: 15.02.2017 Decision :Deferred. 267 Case No.:55/4/82- ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00118/AM17/ RLA File :03/94/040/01044/AM16/ Lic.No/Date:0310803171 09.03.2016 Defer Date: 15.02.2017

268 Case No.:30/2/82- ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00030/AM17/ RLA File :03/95/040/00940/AM16/ Lic.No/Date:0310803176 09.03.2016 Defer Date: 15.02.2017 Decision :Deferred. 269 Case No.:31/2/82- ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00031/AM17/ RLA File :03/95/040/00931/AM16/ Lic.No/Date:0310803177 09.03.2016 Defer Date: 15.02.2017 Decision :Deferred. 270 Case No.:3/2/82-ALC4/2016 Party Name:RONAK CHEMICALS Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00003/AM17/ RLA File :34/24/040/00329/AM16/ Lic.No/Date:3410041957 09.03.2016 Defer Date: 15.02.2017 271 Case No.:176/10/82- ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Approved HQ File :01/82/050/00522/AM17/ RLA File :31/83/040/00178/AM16/ Lic.No/Date:3110066046 14.03.2016 Defer Date: Decision :The Committee decided to ratify norms 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 272 Case No.:13/1/82- ALC1/2016 Party Name:ONEIRO CHEMICALS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 273 Case No.:37/4/82- ALC4/2016 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision : DML called for from the firm by NC in its meeting No.14 dated 29.11.2016 is awaited. The Committee accordingly deferred the case. 274 Case No.:26/4/82- ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE Meet No/Date:16/82- ALC4/2016 Status:Deferred

LIMITED, 28.12.2016 HQ File :01/82/050/00089/AM17/ RLA File :03/94/040/01057/AM16/ Lic.No/Date:0310803376 16.03.2016 Defer Date: 15.02.2017 Decision :Deferred. 275 Case No.:7/4/82-ALC4/2016 SCIENCES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00070/AM17/ RLA File :05/23/040/00468/AM16/ Lic.No/Date:0510397952 17.03.2016 Defer Date: 15.02.2017 Decision :Deferred. 276 Case No.:13/4/82- ALC4/2016 SCIENCES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00076/AM17/ RLA File :05/23/040/00390/AM16/ Lic.No/Date:0510397953 17.03.2016 Defer Date: 15.02.2017 Decision :Deferred. 277 Case No.:8/4/82-ALC4/2016 PVT.LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00071/AM17/ RLA File :05/23/040/00541/AM16/ Lic.No/Date:0510397985 18.03.2016 Defer Date: 15.02.2017 278 Case No.:85/4/82- ALC4/2016 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00148/AM17/ RLA File :09/24/040/00742/AM16/ Lic.No/Date:0910063432 18.03.2016 Defer Date: 15.02.2017 Decision :Deferred. 279 Case No.:36/4/82- ALC4/2016 Party Name:INDOFIL INDUSTRIES LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00099/AM17/ RLA File :03/94/040/01056/AM16/ Lic.No/Date:0310803468 21.03.2016 Defer Date: 15.02.2017 Decision :Deferred. 280 Case No.:81/4/82- ALC4/2016 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00144/AM17/ RLA File :03/95/040/00984/AM16/ Lic.No/Date:0310803500 22.03.2016 Defer Date: 15.02.2017 Decision :Deferred.

281 Case No.:50/4/82- ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00113/AM17/ RLA File :03/94/040/01070/AM16/ Lic.No/Date:0310803526 23.03.2016 Defer Date: 15.02.2017 Decision :Deferred. 282 Case No.:108/7/82- ALC4/2016 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00282/AM17/ RLA File :05/23/040/00518/AM16/ Lic.No/Date:0510398017 23.03.2016 Defer Date: 15.02.2017 283 Case No.:186/10/82- ALC4/2016 Party Name:VOVANTIS LABORATORIES PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 284 Case No.:43/4/82- ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 285 Case No.:69/4/82- ALC4/2016 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision : Information has been called for from the firm in NC meeting No.10/82 dated 23.08.2016 is awaited. The Committee accordingly deferred the case. 286 Case No.:76/4/82- ALC4/2016 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00139/AM17/ RLA File :03/95/040/01015/AM16/ Lic.No/Date:0310803674 31.03.2016 Defer Date: 15.02.2017 Decision :Deferred. 287 Case No.:8/10/82- ALC4/2016 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File RLA File Lic.No/Date:0310803722 Defer Date:

:01/82/050/00354/AM17/ :03/94/040/00645/AM16/ 01.04.2016 15.02.2017 Decision :Deferred. 288 Case No.:92/4/82- ALC4/2016 Party Name:SWATI MENTHOL & ALLIED CHEMICALS LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00155/AM17/ RLA File :29/24/040/00010/AM16/ Lic.No/Date:2910025244 06.04.2016 Defer Date: 15.02.2017 Decision :Deferred. 289 Case No.:66/2/82- ALC4/2016 Party Name:ENCEE AROMATICS PVT. LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 290 Case No.:167/10/82- ALC4/2016 Party Name:OPTIMUS Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00513/AM17/ RLA File :09/24/040/00777/AM16/ Lic.No/Date:0910063505 15.04.2016 Defer Date: 15.02.2017 291 Case No.:127/10/82- ALC4/2016 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 292 Case No.:86/4/82- ALC4/2016 PVT LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00149/AM17/ RLA File :52/24/040/00001/AM17/ Lic.No/Date:5210041862 19.04.2016 Defer Date: 15.02.2017 Decision :deferred. 293 Case No.:3/10/82-ALC4/2016 Party Name:INDOCO REMEDIES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00349/AM17/ RLA File :03/94/040/00042/AM17/ Lic.No/Date:0310804024 20.04.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/522/2015-PI(Norms) dated 19.01.2016, uploaded

294 Case No.:69/2/82-ALC4/2016 Party Name:ALMELO PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00063/AM17/ RLA File :09/24/040/00739/AM16/ Lic.No/Date:0910063533 21.04.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/537/2015-PI(Norms) dated December 2015, 295 Case No.:98/10/82- ALC4/2016 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Approved HQ File :01/82/050/00444/AM17/ RLA File :17/24/040/00006/AM17/ Lic.No/Date:1710006305 21.04.2016 Defer Date: Decision : The Committee decided to ratify norms based on recommendation of D/o C&PC forwarded vide U.O.No.14010/78/2012-Ch-II dated 04.03.2016 uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 296 Case No.:99/10/82-ALC4/2016 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00445/AM17/ RLA File :17/24/040/00005/AM17/ Lic.No/Date:1710006311 22.04.2016 Defer Date: Decision : The Committee decided to ratify norms based on recommendation of D/o C&PC forwarded vide U.O.No.14010/78/2012-Ch-II dated 04.03.2016 uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 297 Case No.:164/10/82- ALC4/2016 Party Name:GLAND PHARMA LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 298 Case No.:125/10/82- ALC4/2016 Party Name:OPTIMUS Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00471/AM17/ RLA File :09/24/040/00033/AM17/ Lic.No/Date:0910063570 29.04.2016 Defer Date: 15.02.2017 299 Case No.:7/6/82-ALC4/2016 Party Name:MANGALAM ORGANICS LIMITED (FORMERLY DUJODWALA Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00174/AM17/ RLA File :03/95/040/00013/AM17/ Lic.No/Date:0310804365 03.05.2016 Defer Date: 15.02.2017

Decision :Deferred. 300 Case No.:174/10/82- ALC4/2016 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00520/AM17/ RLA File :05/23/040/00038/AM17/ Lic.No/Date:0510398377 04.05.2016 Defer Date: 15.02.2017 301 Case No.:175/10/82- ALC4/2016 Party Name:KLJ Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00521/AM17/ RLA File :05/23/040/00032/AM17/ Lic.No/Date:0510398379 04.05.2016 Defer Date: 15.02.2017 Decision : Deferred. 302 Case No.:132/10/82- ALC4/2016 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00478/AM17/ RLA File :09/24/040/00040/AM17/ Lic.No/Date:0910063583 04.05.2016 Defer Date: 15.02.2017 303 Case No.:181/10/82- ALC4/2016 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 304 Case No.:9/10/82-ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00355/AM17/ RLA File :03/94/040/00077/AM17/ Lic.No/Date:0310804424 05.05.2016 Defer Date: taken by NC in its meeting No.18/82 dated 19.12.2013 , uploaded at the end of these minutes or 305 Case No.:6/10/82- ALC4/2016 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00352/AM17/ RLA File :05/24/040/00054/AM17/ Lic.No/Date:0510398413 06.05.2016 Defer Date: 15.02.2017 Decision : 306 Case No.:146/10/82- Party Name:PORUS Meet No/Date:16/82- Status:Deferred

ALC4/2016 LABORATORIES PVT LTD ALC4/2016 28.12.2016 HQ File :01/82/050/00492/AM17/ RLA File :09/24/040/00044/AM17/ Lic.No/Date:0910063608 09.05.2016 Defer Date: 15.02.2017 Decision :Deferred. 307 Case No.:178/10/82- ALC4/2016 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00524/AM17/ RLA File :34/24/040/00354/AM16/ Lic.No/Date:3410042154 10.05.2016 Defer Date: 15.02.2017 308 Case No.:77/10/82- ALC4/2016 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00423/AM17/ RLA File :13/24/040/00004/AM17/ Lic.No/Date:1310048244 11.05.2016 Defer Date: 15.02.2017 309 Case No.:71/10/82- ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00417/AM17/ RLA File :05/24/040/00056/AM17/ Lic.No/Date:0510398495 13.05.2016 Defer Date: 15.02.2017 310 Case No.:169/10/82- ALC4/2016 Party Name:BIOLOGICAL E LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00515/AM17/ RLA File :09/24/040/00007/AM17/ Lic.No/Date:0910063629 17.05.2016 Defer Date: 15.02.2017 Decision : Deferred for want of comments from DBT.. 311 Case No.:94/10/82- ALC4/2016 Party Name:KLJ Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 312 Case No.:126/10/82- ALC4/2016 Party Name:BIOLOGICAL E LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00472/AM17/ RLA File :09/24/040/00306/AM15/ Lic.No/Date:0910063657 19.05.2016 Defer Date: 15.02.2017 Decision : Deferred for want of comments from DBT.

313 Case No.:149/10/82- ALC4/2016 Party Name:BIOLOGICAL E LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00495/AM17/ RLA File :09/24/040/00546/AM16/ Lic.No/Date:0910063659 19.05.2016 Defer Date: 15.02.2017 Decision : Deferred for want of comments from DBT. 314 Case No.:72/10/82- ALC4/2016 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 315 Case No.:73/10/82- ALC4/2016 Party Name:VDH CHEM TECH PVT. LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 316 Case No.:156/7/82- ALC4/2016 Party Name:AMINES & Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00330/AM17/ RLA File :03/94/040/00147/AM17/ Lic.No/Date:0310804903 23.05.2016 Defer Date:16.12.2016 Decision :Deferred. 317 Case No.:130/10/82- ALC4/2016 Party Name:SRINI PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 318 Case No.:83/10/82- ALC4/2016 Party Name:STERILE INDIA PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 319 Case No.:79/10/82- ALC4/2016 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00425/AM17/ RLA File :05/23/040/00075/AM17/ Lic.No/Date:0510398581 24.05.2016 Defer Date: 15.02.2017

320 Case No.:74/10/82- ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 321 Case No.:75/10/82- ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 322 Case No.:185/10/82- ALC4/2016 Party Name:PAUSHAK LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00531/AM17/ RLA File :34/24/040/00037/AM17/ Lic.No/Date:3410042207 25.05.2016 Defer Date: 15.02.2017 323 Case No.:87/10/82- ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00433/AM17/ RLA File :05/24/040/00058/AM17/ Lic.No/Date:0510398614 25.05.2016 Defer Date: 15.02.2017 324 Case No.:102/10/82- ALC4/2016 Party Name:IKRISH HEALTHCARE PVT.LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00448/AM17/ RLA File :05/23/040/00091/AM17/ Lic.No/Date:0510398628 26.05.2016 Defer Date: 15.02.2017 325 Case No.:68/10/82- ALC4/2016 PVT.LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 326 Case No.:65/10/82- ALC4/2016 Party Name:KORES (INDIA) LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 327 Case No.:88/10/82- ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00434/AM17/ RLA File :05/24/040/00083/AM17/ Lic.No/Date:0510398625 26.05.2016 Defer Date: 15.02.2017 328 Case No.:91/10/82-ALC4/2016 Party Name:VIC INDUSTRIES, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00437/AM17/ RLA File :17/24/040/00028/AM17/ Lic.No/Date:1710006343 26.05.2016 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.21/82 dated 23.08.2011, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 329 Case No.:117/10/82- ALC4/2016 Party Name:DR. REDDYS Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 330 Case No.:92/10/82-ALC4/2016 Party Name:ESTEEM INDUSTRIES PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00438/AM17/ RLA File :17/24/040/00030/AM17/ Lic.No/Date:1710006345 27.05.2016 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.22/82 dated 20.02.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 331 Case No.:112/10/82- ALC4/2016 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00458/AM17/ RLA File :05/23/040/00094/AM17/ Lic.No/Date:0510398655 27.05.2016 Defer Date: 15.02.2017 332 Case No.:142/16/82- ALC4/2016 Party Name:ENCEE AROMATICS PVT. LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File RLA File Lic.No/Date:3210077902 Defer Date:

:01/82/050/00959/AM17/ :32/21/040/00021/AM17/ 30.05.2016 Decision :Deferred. 333 Case No.:36/10/82- ALC4/2016 Party Name:FRESENIUS KABI INDIA PRIVATE LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00382/AM17/ RLA File :03/94/040/00145/AM17/ Lic.No/Date:0310805018 30.05.2016 Defer Date: 15.02.2017 334 Case No.:34/10/82- ALC4/2016 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00380/AM17/ RLA File :03/94/040/00048/AM17/ Lic.No/Date:0310805010 30.05.2016 Defer Date: 15.02.2017 Decision :Deferred. 335 Case No.:35/10/82- ALC4/2016 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00381/AM17/ RLA File :03/94/040/00030/AM17/ Lic.No/Date:0310805009 30.05.2016 Defer Date: 15.02.2017 Decision :Deferred. 336 Case No.:123/10/82- ALC4/2016 Party Name:NIFTY LABS PVT LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 337 Case No.:44/10/82-ALC4/2016 Party Name:PRIVI ORGANICS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00390/AM17/ RLA File :03/95/040/00128/AM17/ Lic.No/Date:0310805023 30.05.2016 Defer Date: taken by NC in its meeting No.21/82 dated 23.08.2011, uploaded at the end of these minutes or 338 Case No.:103/10/82- ALC4/2016 Party Name:AGSON GLOBAL PRIVATE LIMITED. Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred.

339 Case No.:33/10/82-ALC4/2016 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: approved HQ File :01/82/050/00379/AM17/ RLA File :03/94/040/00044/AM17/ Lic.No/Date:0310805039 31.05.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION A-3667 published earlier vide PN No.64 dated 17.3.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 340 Case No.:97/10/82- ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00443/AM17/ RLA File :05/24/040/00066/AM17/ Lic.No/Date:0510398693 31.05.2016 Defer Date: 15.02.2017 341 Case No.:187/10/82- ALC4/2016 Party Name:WINDLAS HEALTH CARE PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 342 Case No.:54/10/82- ALC4/2016 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00400/AM17/ RLA File :04/24/040/00038/AM17/ Lic.No/Date:0410162004 02.06.2016 Defer Date: 15.02.2017 Decision :Information called for from the firm in NC meeting No.14 dated 29.11.2016 is awaited. The Committee decided to defer the case. 343 Case No.:69/10/82- ALC4/2016 PVT.LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 344 Case No.:70/10/82- ALC4/2016 PVT.LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 345 Case No.:48/10/82- Party Name:AGIO Meet No/Date:16/82- Status:Deferred

ALC4/2016 PHARMACEUTICALS LTD ALC4/2016 28.12.2016 HQ File :01/82/050/00394/AM17/ RLA File :03/94/040/00051/AM17/ Lic.No/Date:0310805268 07.06.2016 Defer Date: 15.02.2017 346 Case No.:50/10/82- ALC4/2016 Party Name:AGIO PHARMACEUTICALS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 347 Case No.:51/10/82- ALC4/2016 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00397/AM17/ RLA File :03/94/040/00196/AM17/ Lic.No/Date:0310805264 07.06.2016 Defer Date: 15.02.2017 Decision :Deferred. 348 Case No.:11/10/82- ALC4/2016 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00357/AM17/ RLA File :08/24/040/00088/AM17/ Lic.No/Date:0810138109 07.06.2016 Defer Date: 15.02.2017 349 Case No.:129/10/82- ALC4/2016 Party Name:MYLAN Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision : Information called for from the firm in NC meeting No.14 dated 29.11.2016 is awaited. The Committee accordingly decided to defer the case. 350 Case No.:134/10/82- ALC4/2016 Party Name:ALPHAMED FORMULATIONS P LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00480/AM17/ RLA File :09/24/040/00087/AM17/ Lic.No/Date:0910063771 08.06.2016 Defer Date: 15.02.2017 Decision : The Committee noted that copy of Master Batch formula duly authenticated by Q.C. in-charge had been called for from the firm in NC meeting No.14 dated 29.11.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 351 Case No.:18/10/82- ALC4/2016 Party Name:ARJUN CHEMICALS PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File RLA File Lic.No/Date:0410162023 Defer Date:

:01/82/050/00364/AM17/ :04/24/040/00041/AM17/ 08.06.2016 15.02.2017 Decision :Deferred. 352 Case No.:121/10/82- ALC4/2016 Party Name:OPTIMUS Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 353 Case No.:151/10/82- ALC4/2016 Party Name:INCHEM LABORATORIES PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision : The Committee noted that information called for from the firm in NC meeting No.14 dated 29.11.2016 is awaited. The Committee accordingly decided to defer the case. 354 Case No.:49/10/82- ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00395/AM17/ RLA File :03/94/040/00181/AM17/ Lic.No/Date:0310805345 09.06.2016 Defer Date: 15.02.2017 355 Case No.:179/10/82- ALC4/2016 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00525/AM17/ RLA File :34/24/040/00064/AM17/ Lic.No/Date:3410042257 10.06.2016 Defer Date: 15.02.2017 Decision :Deferred. 356 Case No.:12/10/82- ALC4/2016 Party Name:CAPLIN POINT LABORATORIES LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00358/AM17/ RLA File :04/24/040/00043/AM17/ Lic.No/Date:0410162034 10.06.2016 Defer Date: 15.02.2017 357 Case No.:89/10/82-ALC4/2016 Party Name:ESTEEM INDUSTRIES PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00435/AM17/ RLA File :17/24/040/00037/AM17/ Lic.No/Date:1710006358 10.06.2016 Defer Date: Decision : The Committee decided to ratify norms based on recommendation of D/o C&PC forwarded vide U.O.No.14010/78/2012-Ch-II dated 04.03.2016 uploaded at the end of these

minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 358 Case No.:90/10/82-ALC4/2016 Party Name:ESTEEM INDUSTRIES PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00436/AM17/ RLA File :17/24/040/00039/AM17/ Lic.No/Date:1710006359 10.06.2016 Defer Date: Decision : The Committee decided to ratify norms based on recommendation of D/o C&PC forwarded vide U.O.No.14010/78/2012-Ch-II dated 04.03.2016 uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 359 Case No.:46/10/82- ALC4/2016 Party Name:NOCIL LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00392/AM17/ RLA File :03/95/040/00134/AM17/ Lic.No/Date:0310805363 10.06.2016 Defer Date: 15.02.2017 360 Case No.:47/10/82- ALC4/2016 Party Name:SUNSHIELD CHEMICALS LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00393/AM17/ RLA File :03/95/040/00196/AM17/ Lic.No/Date:0310805364 10.06.2016 Defer Date: 15.02.2017 Decision :Deferred. 361 Case No.:64/10/82- ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00410/AM17/ RLA File :31/83/040/00195/AM16/ Lic.No/Date:3110066174 13.06.2016 Defer Date: 15.02.2017 Decision :Deferred. 362 Case No.:14/10/82- ALC4/2016 Party Name:CAPLIN POINT LABORATORIES LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00360/AM17/ RLA File :04/24/040/00049/AM17/ Lic.No/Date:0410162041 14.06.2016 Defer Date: 15.02.2017 363 Case No.:52/10/82- ALC4/2016 Party Name:CLARIANT INDIA LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00398/AM17/ RLA File :03/94/040/00223/AM17/ Lic.No/Date:0310805476 14.06.2016 Defer Date: 15.02.2017 Decision :Deferred.

364 Case No.:26/10/82- ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 365 Case No.:27/10/82- ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 366 Case No.:137/10/82- ALC4/2016 Party Name:PROCESS AGROCHEM INDUSTRIES PVT. LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision : Deferred for want of comments from MSME. 367 Case No.:19/10/82- ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 368 Case No.:60/10/82- ALC4/2016 Party Name:VENUS REMEDIES LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00406/AM17/ RLA File :22/24/040/00014/AM17/ Lic.No/Date:2210015501 14.06.2016 Defer Date: 15.02.2017 369 Case No.:61/10/82- ALC4/2016 Party Name:ANUJA HEALTHCARE LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 370 Case No.:25/10/82- ALC4/2016 Party Name:ASTEC LIFESCIENCES LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File RLA File Lic.No/Date:0310805494 Defer Date:

:01/82/050/00371/AM17/ :03/94/040/00132/AM17/ 15.06.2016 15.02.2017 371 Case No.:154/10/82- ALC4/2016 Party Name:MYLAN Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00500/AM17/ RLA File :09/24/040/00084/AM17/ Lic.No/Date:0910063799 15.06.2016 Defer Date: 15.02.2017 372 Case No.:23/10/82- ALC4/2016 Party Name:RECKITT BENCKISER ( INDIA) PRIVATE LIMITED, Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 373 Case No.:62/10/82- ALC4/2016 PVT LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00408/AM17/ RLA File :52/24/040/00019/AM17/ Lic.No/Date:5210041935 17.06.2016 Defer Date: 15.02.2017 Decision :Deferred. 374 Case No.:57/10/82- ALC4/2016 SCIENCES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00403/AM17/ RLA File :05/23/040/00054/AM17/ Lic.No/Date:0510398839 17.06.2016 Defer Date: 15.02.2017 Decision :Deferred. 375 Case No.:40/10/82- ALC4/2016 Party Name:UNIMAX LABORATORIES PVT.LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00386/AM17/ RLA File :03/95/040/00191/AM17/ Lic.No/Date:0310805570 17.06.2016 Defer Date: 15.02.2017 376 Case No.:58/10/82- ALC4/2016 PVT LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00404/AM17/ RLA File :52/24/040/00018/AM17/ Lic.No/Date:5210041937 20.06.2016 Defer Date: 15.02.2017 Decision :Deferred. 377 Case No.:30/10/82- ALC4/2016 Party Name:DANOPHARM CHEMICALS PRIVATE Meet No/Date:16/82- ALC4/2016 Status:Deferred

LTD. 28.12.2016 HQ File :01/82/050/00376/AM17/ RLA File :03/94/040/00150/AM17/ Lic.No/Date:0310805606 20.06.2016 Defer Date: 15.02.2017 Decision : Deferred. 378 Case No.:29/10/82- ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 379 Case No.:33/16/82-ALC4/2016 Party Name:SHREE JAYA LABORATORIES PVT LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00850/AM17/ RLA File :09/24/040/00128/AM17/ Lic.No/Date:0910063810 21.06.2016 Defer Date: 380 Case No.:78/10/82- ALC4/2016 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00424/AM17/ RLA File :13/24/040/00009/AM17/ Lic.No/Date:1310048295 22.06.2016 Defer Date: 15.02.2017 381 Case No.:56/10/82- ALC4/2016 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision : The Committee noted that information called for from the firm in NC meeting No.14 dated 29.11.2016 is awaited. The Committee accordingly decided to defer the case. 382 Case No.:105/10/82- ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 383 Case No.:35/16/82-ALC4/2016 Party Name:SHREE JAYA LABORATORIES PVT LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00852/AM17/ RLA File :09/24/040/00154/AM17/ Lic.No/Date:0910063814 22.06.2016 Defer Date: 15.02.2017

384 Case No.:81/16/82-ALC4/2016 Party Name:VISION DRUGS PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00898/AM17/ RLA File :09/24/040/00131/AM17/ Lic.No/Date:0910063815 22.06.2016 Defer Date: 15.02.2017 385 Case No.:83/16/82- ALC4/2016 LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00900/AM17/ RLA File :09/24/040/00101/AM17/ Lic.No/Date:0910063816 22.06.2016 Defer Date15.02.2017 Decision :Deferred. 386 Case No.:58/16/82-ALC4/2016 Party Name:DISTO PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00875/AM17/ RLA File :09/24/040/00152/AM17/ Lic.No/Date:0910063836 23.06.2016 Defer Date: 15.02.2017 387 Case No.:109/10/82- ALC4/2016 Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision : The Committee noted that information called for from the firm in NC meeting No.14 dated 29.11.2016 is awaited. The Committee accordingly decided to defer the case. 388 Case No.:28/10/82-ALC4/2016 Party Name:GITANJALI CHEMICALS PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00374/AM17/ RLA File :03/94/040/00202/AM17/ Lic.No/Date:0310805671 23.06.2016 Defer Date: Decision : The Committee decided to ratify norms based on earlier decision taken by NC in its meeting No.19/82 dated 02.01.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 389 Case No.:40/16/82-ALC4/2016 Party Name:OPTIMUS Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00857/AM17/ RLA File :09/24/040/00166/AM17/ Lic.No/Date:0910063840 24.06.2016 Defer Date: 15.02.2017

Decision: Deferred for want of comments from DoP. 390 Case No.:59/16/82-ALC4/2016 Party Name:VINDHYA PHARMA (INDIA)PVT LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00876/AM17/ RLA File :09/24/040/00153/AM17/ Lic.No/Date:0910063841 24.06.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/215/2016-PI(Norms) dated Sept. 2016, uploaded 391 Case No.:110/10/82- ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00456/AM17/ RLA File :31/83/040/00027/AM17/ Lic.No/Date:3110066198 27.06.2016 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.12/82 dated 15.12.2014, uploaded at the end of these minutes or as 392 Case No.:37/10/82-ALC4/2016 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00383/AM17/ RLA File :03/95/040/00258/AM17/ Lic.No/Date:0310805756 28.06.2016 Defer Date: taken by NC in its meeting No.10/82 dated 22.08.2013, uploaded at the end of these minutes or 393 Case No.:38/10/82- ALC4/2016 Party Name:ORBIT LIFE SCIENCE PVT. LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00384/AM17/ RLA File :03/95/040/00234/AM17/ Lic.No/Date:0310805748 28.06.2016 Defer Date: 15.02.2017 394 Case No.:39/10/82- ALC4/2016 Party Name:ORBIT LIFE SCIENCE PVT. LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00385/AM17/ RLA File :03/95/040/00235/AM17/ Lic.No/Date:0310805747 28.06.2016 Defer Date: 15.02.2017 395 Case No.:61/16/82-ALC4/2016 Party Name:VIVIMED LABS LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred

HQ File :01/82/050/00878/AM17/ RLA File :09/24/040/00145/AM17/ Lic.No/Date:0910063847 28.06.2016 Defer Date: 15.02.2017 Decision :Deferred. 396 Case No.:92/16/82-ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00909/AM17/ RLA File :09/24/040/00157/AM17/ Lic.No/Date:0910063873 30.06.2016 Defer Date: 15.02.2017 397 Case No.:138/10/82- ALC4/2016 Party Name:PARENTRAL DRUGS INDIA LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00484/AM17/ RLA File :56/24/040/00051/AM16/ Lic.No/Date:5610004939 30.06.2016 Defer Date: 15.02.2017 398 Case No.:56/16/82-ALC4/2016 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00873/AM17/ RLA File :09/24/040/00150/AM17/ Lic.No/Date:0910063877 30.06.2016 Defer Date: 15.02.2017 Decision : Deferred. 399 Case No.:182/10/82- ALC4/2016 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00528/AM17/ RLA File :34/24/040/00095/AM17/ Lic.No/Date:3410042315 30.06.2016 Defer Date: 15.02.2017 Decision :Deferred. 400 Case No.:183/10/82- ALC4/2016 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00529/AM17/ RLA File :34/24/040/00094/AM17/ Lic.No/Date:3410042314 30.06.2016 Defer Date: 15.02.2017 Decision :Deferred. 401 Case No.:104/16/82- ALC4/2016 Party Name:VIRUPAKSHA ORGANICS LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00921/AM17/ RLA File :09/24/040/00173/AM17/ Lic.No/Date:0910063876 30.06.2016 Defer Date: Decision :. The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/214/2016-PI(Norms) dated 2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP

402 Case No.:47/16/82-ALC4/2016 Party Name:DEEPAK NITRITE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00864/AM17/ RLA File :34/24/040/00298/AM16/ Lic.No/Date:3410042323 01.07.2016 Defer Date: 15.02.2017 Decision :Deferred. 403 Case No.:30/16/82-ALC4/2016 Party Name:SRINI PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00847/AM17/ RLA File :09/24/040/00164/AM17/ Lic.No/Date:0910063878 01.07.2016 Defer Date: 15.02.2017 404 Case No.:57/16/82-ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00874/AM17/ RLA File :09/24/040/00025/AM17/ Lic.No/Date:0910063886 04.07.2016 Defer Date: 15.02.2017 405 Case No.:85/10/82- ALC4/2016 SCIENCES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 406 Case No.:86/10/82- ALC4/2016 SCIENCES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00432/AM17/ RLA File :05/23/040/00146/AM17/ Lic.No/Date:0510398970 04.07.2016 Defer Date: 15.02.2017 Decision :Deferred. 407 Case No.:101/10/82- ALC4/2016 SCIENCES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 408 Case No.:135/10/82- ALC4/2016 Party Name:PARENTRAL DRUGS INDIA LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017

409 Case No.:3/8/82-ALC4/2016 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 410 Case No.:5/14/82- ALC4/2016 Party Name:ASTRAL STERITECH PVT. LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00803/AM17/ RLA File :34/24/040/00099/AM17/ Lic.No/Date:3410042324 05.07.2016 Defer Date: 15.02.2017 411 Case No.:2/16/82-ALC4/2016 Party Name:ASTRAL STERITECH PVT. LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00819/AM17/ RLA File :34/24/040/00100/AM17/ Lic.No/Date:3410042325 05.07.2016 Defer Date: 15.02.2017 412 Case No.:2/8/82-ALC4/2016 Party Name:HELLO PAINTS (P) LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :deferred. 413 Case No.:63/16/82-ALC4/2016 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00880/AM17/ RLA File :09/24/040/00178/AM17/ Lic.No/Date:0910063892 06.07.2016 Defer Date: 15.02.2017 414 Case No.:48/16/82-ALC4/2016 Party Name:DEEPAK NITRITE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00865/AM17/ RLA File :34/24/040/00295/AM16/ Lic.No/Date:3410042327 07.07.2016 Defer Date: 15.02.2017 Decision :Deferred. 415 Case No.:4/8/82-ALC4/2016 Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 Decision :Deferred. 416 Case No.:63/10/82- ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00409/AM17/ RLA File :04/24/040/00058/AM17/ Lic.No/Date:0410162083 08.07.2016 Defer Date: 15.02.2017 417 Case No.:82/16/82-ALC4/2016 Party Name:EYTAN LABS LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00899/AM17/ RLA File :09/24/040/00162/AM17/ Lic.No/Date:0910063899 11.07.2016 Defer Date: 15.02.2017 418 Case No.:137/16/82- ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00954/AM17/ RLA File :07/24/040/00130/AM17/ Lic.No/Date:0710110080 12.07.2016 Defer Date: taken by NC in its meeting No.23/82 dated 01.11.2012 , uploaded at the end of these minutes or 419 Case No.:10/14/82- ALC4/2016 Party Name:GLOBAL MEDICINES LTD, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00808/AM17/ RLA File :34/24/040/00101/AM17/ Lic.No/Date:3410042344 12.07.2016 Defer Date: 15.02.2017 420 Case No.:36/16/82-ALC4/2016 Party Name:NATCO PHARMA LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00853/AM17/ RLA File :09/24/040/00169/AM17/ Lic.No/Date:0910063915 13.07.2016 Defer Date: 15.02.2017 421 Case No.:39/16/82-ALC4/2016 Party Name:NATCO PHARMA LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00856/AM17/ RLA File :09/24/040/00168/AM17/ Lic.No/Date:0910063916 13.07.2016 Defer Date: 15.02.2017

422 Case No.:41/16/82-ALC4/2016 Party Name:NATCO PHARMA LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00858/AM17/ RLA File :09/24/040/00167/AM17/ Lic.No/Date:0910063917 13.07.2016 Defer Date: 15.02.2017 423 Case No.:42/16/82-ALC4/2016 Party Name:NIFTY LABS PVT LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00859/AM17/ RLA File :09/24/040/00206/AM17/ Lic.No/Date:0910063914 13.07.2016 Defer Date: 15.02.2017 424 Case No.:106/16/82- ALC4/2016 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00923/AM17/ RLA File :09/24/040/00175/AM17/ Lic.No/Date:0910063913 13.07.2016 Defer Date: 15.02.2017 425 Case No.:29/16/82-ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00846/AM17/ RLA File :09/24/040/00180/AM17/ Lic.No/Date:0910063923 14.07.2016 Defer Date: 15.02.2017 426 Case No.:103/16/82- ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00920/AM17/ RLA File :09/24/040/00174/AM17/ Lic.No/Date:0910063926 14.07.2016 Defer Date: 15.02.2017 427 Case No.:105/16/82- ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00922/AM17/ RLA File :09/24/040/00170/AM17/ Lic.No/Date:0910063925 14.07.2016 Defer Date: 15.02.2017 428 Case No.:82/10/82- ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00428/AM17/ RLA File :31/83/040/00041/AM17/ Lic.No/Date:3110066246 14.07.2016 Defer Date: 15.02.2017

Decision :Deferred. 429 Case No.:84/16/82-ALC4/2016 Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00901/AM17/ RLA File :09/24/040/00224/AM17/ Lic.No/Date:0910063921 14.07.2016 Defer Date: 15.02.2017 430 Case No.:37/16/82-ALC4/2016 Party Name:OPTIMUS Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00854/AM17/ RLA File :09/24/040/00214/AM17/ Lic.No/Date:0910063939 15.07.2016 Defer Date: 431 Case No.:43/16/82-ALC4/2016 Party Name:OPTIMUS Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00860/AM17/ RLA File :09/24/040/00213/AM17/ Lic.No/Date:0910063938 15.07.2016 Defer Date: 15.02.2017 432 Case No.:6/8/82-ALC4/2016 Party Name:ATUL LIMITED, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00344/AM17/ RLA File :08/24/040/00134/AM17/ Lic.No/Date:0810138308 18.07.2016 Defer Date: 15.02.2017 Decision :Deferred. 433 Case No.:16/16/82-ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00833/AM17/ RLA File :09/24/040/00217/AM17/ Lic.No/Date:0910063946 19.07.2016 Defer Date: 15.02.2017 434 Case No.:32/16/82-ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00849/AM17/ RLA File :09/24/040/00218/AM17/ Lic.No/Date:0910063947 19.07.2016 Defer Date: 15.02.2017 435 Case No.:4/14/82- ALC4/2016 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred

HQ File :01/82/050/00802/AM17/ RLA File :34/24/040/00109/AM17/ Lic.No/Date:3410042360 19.07.2016 Defer Date: 15.02.2017 Decision :Deferred. 436 Case No.:12/14/82-ALC4/2016 Party Name:ESTEEM INDUSTRIES PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00810/AM17/ RLA File :17/24/040/00065/AM17/ Lic.No/Date:1710006408 19.07.2016 Defer Date: Decision : The Committee decided to ratify norms based on 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. 437 Case No.:34/16/82-ALC4/2016 Party Name:VIVIMED LABS LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00851/AM17/ RLA File :09/24/040/00199/AM17/ Lic.No/Date:0910063950 20.07.2016 Defer Date: 15.02.2017 Decision :Deferred. 438 Case No.:27/16/82-ALC4/2016 Party Name:BRILLIANT BIO PHARMA PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00844/AM17/ RLA File :09/24/040/00132/AM17/ Lic.No/Date:0910063967 21.07.2016 Defer Date: 15.02.2017 439 Case No.:1/14/82-ALC4/2016 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00799/AM17/ RLA File :34/24/040/00106/AM17/ Lic.No/Date:3410042370 21.07.2016 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.03/82 dated 08.05.2014, uploaded at the end of these minutes or as 440 Case No.:38/16/82-ALC4/2016 Party Name:VIRUPAKSHA ORGANICS LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00855/AM17/ RLA File :09/24/040/00216/AM17/ Lic.No/Date:0910063965 21.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/270/2016-PI(Norms) dated October 2016,

441 Case No.:28/16/82-ALC4/2016 Party Name:GRANULES INDIA LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00845/AM17/ RLA File :09/24/040/00215/AM17/ Lic.No/Date:0910063971 22.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/72/2016-PI(Norms) dated June. 2016, uploaded 442 Case No.:3/14/82- ALC4/2016 Party Name:TRANSPEK INDUSTRY LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00801/AM17/ RLA File :34/24/040/00124/AM17/ Lic.No/Date:3410042372 22.07.2016 Defer Date: 15.02.2017 443 Case No.:60/16/82-ALC4/2016 Party Name:OPTRIX LABORATORIES PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00877/AM17/ RLA File :09/24/040/00235/AM17/ Lic.No/Date:0910063977 25.07.2016 Defer Date: 15.02.2017 444 Case No.:49/16/82-ALC4/2016 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00866/AM17/ RLA File :34/24/040/00127/AM17/ Lic.No/Date:3410042385 27.07.2016 Defer Date: 15.02.2017 445 Case No.:85/16/82-ALC4/2016 Party Name:OPTRIX LABORATORIES PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00902/AM17/ RLA File :09/24/040/00234/AM17/ Lic.No/Date:0910063995 28.07.2016 Defer Date: 15.02.2017 446 Case No.:31/16/82-ALC4/2016 Party Name:OPTRIX LABORATORIES PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00848/AM17/ RLA File :09/24/040/00236/AM17/ Lic.No/Date:0910063999 29.07.2016 Defer Date: 15.02.2017 447 Case No.:24/16/82-ALC4/2016 Party Name:SRINI PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred

HQ File :01/82/050/00841/AM17/ RLA File :09/24/040/00243/AM17/ Lic.No/Date:0910064002 02.08.2016 Defer Date: 15.02.2017 448 Case No.:9/14/82- ALC4/2016 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00807/AM17/ RLA File :34/24/040/00133/AM17/ Lic.No/Date:3410042403 04.08.2016 Defer Date: 15.02.2017 449 Case No.:25/16/82-ALC4/2016 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00842/AM17/ RLA File :09/24/040/00248/AM17/ Lic.No/Date:0910064009 04.08.2016 Defer Date: 15.02.2017 Decision : Deferred 450 Case No.:21/16/82-ALC4/2016 Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00838/AM17/ RLA File :09/24/040/00151/AM17/ Lic.No/Date:0910064013 08.08.2016 Defer Date: 15.02.2017 451 Case No.:139/16/82- ALC4/2016 Party Name:ARJUN CHEMICALS PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00956/AM17/ RLA File :04/24/040/00080/AM17/ Lic.No/Date:0410162170 08.08.2016 Defer Date: 15.02.2017 Decision :Deferred. 452 Case No.:50/16/82-ALC4/2016 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00867/AM17/ RLA File :34/24/040/00126/AM17/ Lic.No/Date:3410042426 09.08.2016 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.15/82 dated 31.10.2013 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 453 Case No.:23/16/82-ALC4/2016 Party Name:MYLAN Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00840/AM17/ RLA File :09/24/040/00210/AM17/ Lic.No/Date:0910064015 09.08.2016 Defer Date: 15.02.2017

454 Case No.:14/16/82-ALC4/2016 Party Name:DR. REDDYS Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00831/AM17/ RLA File :09/24/040/00229/AM17/ Lic.No/Date:0910064024 11.08.2016 Defer Date: 15.02.2017 455 Case No.:12/16/82-ALC4/2016 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00829/AM17/ RLA File :09/24/040/00251/AM17/ Lic.No/Date:0910064036 12.08.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/679/2016-PI(Norms) dated 12.03.2013, uploaded 456 Case No.:22/16/82-ALC4/2016 Party Name:VIVIMED LABS LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00839/AM17/ RLA File :09/24/040/00211/AM17/ Lic.No/Date:0910064039 16.08.2016 Defer Date: 15.02.2017 Decision :Deferred. 457 Case No.:13/16/82-ALC4/2016 Party Name:NIFTY LABS PVT LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00830/AM17/ RLA File :09/24/040/00261/AM17/ Lic.No/Date:0910064050 17.08.2016 Defer Date: 15.02.2017 458 Case No.:9/16/82-ALC4/2016 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00826/AM17/ RLA File :34/24/040/00146/AM17/ Lic.No/Date:3410042456 19.08.2016 Defer Date: 15.02.2017 459 Case No.:15/16/82-ALC4/2016 Party Name:GRANULES INDIA LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00832/AM17/ RLA File :09/24/040/00264/AM17/ Lic.No/Date:0910064057 19.08.2016 Defer Date: 15.02.2017 460 Case No.:1/16/82-ALC4/2016 Party Name:SUN PHARMACEUTICAL Meet No/Date:16/82- ALC4/2016 Status: Deferred

INDUSTRIES LTD., 28.12.2016 HQ File :01/82/050/00818/AM17/ RLA File :05/24/040/00202/AM17/ Lic.No/Date:0510399511 19.08.2016 Defer Date: 15.02.2017 461 Case No.:44/16/82-ALC4/2016 Party Name:GRANULES INDIA LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00861/AM17/ RLA File :09/24/040/00274/AM17/ Lic.No/Date:0910064061 23.08.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/473/2013-PI(Norms) dated 21st October 2013, 462 Case No.:45/16/82-ALC4/2016 Party Name:GRANULES INDIA LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00862/AM17/ RLA File :09/24/040/00273/AM17/ Lic.No/Date:0910064065 24.08.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/270/2016-PI(Norms) dated October 2016, 463 Case No.:46/16/82-ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00863/AM17/ RLA File :09/24/040/00276/AM17/ Lic.No/Date:0910064077 26.08.2016 Defer Date: 15.02.2017 464 Case No.:140/16/82- ALC4/2016 Party Name:NUTRA SPECIALITIES PVT. LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00957/AM17/ RLA File :04/24/040/00265/AM16/ Lic.No/Date:0410162242 02.09.2016 Defer Date: 15.02.2017 465 Case No.:100/16/82- ALC4/2016 Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00917/AM17/ RLA File :05/23/040/00272/AM17/ Lic.No/Date:0510399660 08.09.2016 Defer Date: 15.02.2017 466 Case No.:1/12/82-ALC4/2016 Party Name:INTAS PHARMACEUTICALS LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved

HQ File :01/82/050/00625/AM17/ RLA File :08/24/040/00236/AM17/ Lic.No/Date:0810138639 09.09.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/815/2013-PI(Norms) dated August 2014, 467 Case No.:3/12/82- ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 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: 15.02.2017 468 Case No.:4/12/82- ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00628/AM17/ RLA File :09/24/040/00290/AM17/ Lic.No/Date:0910064145 16.09.2016 Defer Date: 15.02.2017 469 Case No.:90/16/82-ALC4/2016 Party Name:MAHIMA LIFE SCIENCES PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00907/AM17/ RLA File :05/24/040/00229/AM17/ Lic.No/Date:0510399749 16.09.2016 Defer Date: 15.02.2017 470 Case No.:91/16/82-ALC4/2016 Party Name:MAHIMA LIFE SCIENCES PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00908/AM17/ RLA File :05/24/040/00216/AM17/ Lic.No/Date:0510399740 16.09.2016 Defer Date: 15.02.2017 471 Case No.:94/16/82-ALC4/2016 Party Name:MAHIMA LIFE SCIENCES PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00911/AM17/ RLA File :05/24/040/00230/AM17/ Lic.No/Date:0510399750 16.09.2016 Defer Date: 15.02.2017 472 Case No.:95/16/82-ALC4/2016 Party Name:MAHIMA LIFE SCIENCES PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00912/AM17/ RLA File :05/24/040/00222/AM17/ Lic.No/Date:0510399746 16.09.2016 Defer Date: 15.02.2017

473 Case No.:96/16/82-ALC4/2016 Party Name:MAHIMA LIFE SCIENCES PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00913/AM17/ RLA File :05/24/040/00223/AM17/ Lic.No/Date:0510399747 16.09.2016 Defer Date: 15.02.2017 474 Case No.:97/16/82-ALC4/2016 Party Name:MAHIMA LIFE SCIENCES PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00914/AM17/ RLA File :05/24/040/00261/AM17/ Lic.No/Date:0510399752 16.09.2016 Defer Date: 15.02.2017 475 Case No.:110/16/82- ALC4/2016 Party Name:MAHIMA LIFE SCIENCES PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00927/AM17/ RLA File :05/24/040/00207/AM17/ Lic.No/Date:0510399738 16.09.2016 Defer Date: 15.02.2017 476 Case No.:119/16/82- ALC4/2016 Party Name:MAHIMA LIFE SCIENCES PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00936/AM17/ RLA File :05/24/040/00220/AM17/ Lic.No/Date:0510399742 16.09.2016 Defer Date: 15.02.2017 477 Case No.:4/16/82-ALC4/2016 Party Name:DIVIS LABORATORIES LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00821/AM17/ RLA File :09/24/040/00329/AM17/ Lic.No/Date:0910064154 19.09.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/455/2014-PI(Norms) dated February 2015, 478 Case No.:6/16/82-ALC4/2016 Party Name:DIVIS LABORATORIES LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00823/AM17/ RLA File :09/24/040/00327/AM17/ Lic.No/Date:0910064153 19.09.2016 Defer Date: 15.02.2017 479 Case No.:7/16/82-ALC4/2016 Party Name:DIVIS LABORATORIES LTD Meet No/Date:16/82- ALC4/2016 Status: Approved

28.12.2016 HQ File :01/82/050/00824/AM17/ RLA File :09/24/040/00328/AM17/ Lic.No/Date:0910064152 19.09.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/646/2013-PI(Norms) dated 24.12.2013, uploaded 480 Case No.:99/16/82-ALC4/2016 Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00916/AM17/ RLA File :05/23/040/00280/AM17/ Lic.No/Date:0510399773 20.09.2016 Defer Date: 15.02.2017 Decision :Deferred. 481 Case No.:70/16/82-ALC4/2016 Party Name:INDO PHYTO CHEMICALS PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00887/AM17/ RLA File :05/23/040/00237/AM17/ Lic.No/Date:0510399777 20.09.2016 Defer Date: 15.02.2017 Decision :Deferred. 482 Case No.:76/16/82-ALC4/2016 Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00893/AM17/ RLA File :05/23/040/00162/AM17/ Lic.No/Date:0510399799 21.09.2016 Defer Date: 15.02.2017 Decision :Deferred. 483 Case No.:141/16/82- ALC4/2016 Party Name:SANMAR SPECIALITY CHEMICALS LIMITED, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00958/AM17/ RLA File :04/24/040/00069/AM17/ Lic.No/Date:0410162295 21.09.2016 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision of NC taken in its meeting No.10/82 dated 05.06.2012 for same firm, 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. 484 Case No.:112/16/82- ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00929/AM17/ RLA File :05/24/040/00282/AM17/ Lic.No/Date:0510399789 21.09.2016 Defer Date: 15.02.2017 485 Case No.:72/16/82-ALC4/2016 Party Name:ASIATIC DRUGS &PHARMACEUTICALS PVT. Meet No/Date:16/82- ALC4/2016 Status: Deferred

LTD. 28.12.2016 HQ File :01/82/050/00889/AM17/ RLA File :05/23/040/00214/AM17/ Lic.No/Date:0510399816 22.09.2016 Defer Date: 15.02.2017 486 Case No.:6/14/82- ALC4/2016 Party Name:SWATI MENTHOL & ALLIED CHEMICALS LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00804/AM17/ RLA File :29/24/040/00002/AM17/ Lic.No/Date:2910025262 23.09.2016 Defer Date: 15.02.2017 Decision :Deferred. 487 Case No.:93/16/82-ALC4/2016 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00910/AM17/ RLA File :05/24/040/00301/AM17/ Lic.No/Date:0510399916 27.09.2016 Defer Date: 15.02.2017 Decision :Deferred. 488 Case No.:78/16/82-ALC4/2016 Party Name:KLJ Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00895/AM17/ RLA File :05/23/040/00304/AM17/ Lic.No/Date:0510399927 28.09.2016 Defer Date: 15.02.2017 Decision :Deferred. 489 Case No.:109/16/82- ALC4/2016 Party Name:PANERA BIOTEC PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00926/AM17/ RLA File :05/24/040/00307/AM17/ Lic.No/Date:0510399924 28.09.2016 Defer Date: 15.02.2017 Decision : Deferred for want of comments from DBT. 490 Case No.:111/16/82- ALC4/2016 Party Name:SHREE BANKEY BEHARI LAL AROMATICS Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00928/AM17/ RLA File :05/24/040/00295/AM17/ Lic.No/Date:0510399921 28.09.2016 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. RA concerned may take further necessary action as per decision of NC. 491 Case No.:128/16/82- ALC4/2016 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00945/AM17/ RLA File :08/24/040/00260/AM17/ Lic.No/Date:0810138777 30.09.2016 Defer Date: 15.02.2017

492 Case No.:124/16/82- ALC4/2016 Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00941/AM17/ RLA File :08/24/040/00256/AM17/ Lic.No/Date:0810138780 30.09.2016 Defer Date: 15.02.2017 493 Case No.:125/16/82- ALC4/2016 Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00942/AM17/ RLA File :08/24/040/00255/AM17/ Lic.No/Date:0810138776 30.09.2016 Defer Date: 15.02.2017 494 Case No.:69/16/82-ALC4/2016 Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00886/AM17/ RLA File :05/23/040/00310/AM17/ Lic.No/Date:0510399960 03.10.2016 Defer Date: 495 Case No.:77/16/82-ALC4/2016 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00894/AM17/ RLA File :05/23/040/00188/AM17/ Lic.No/Date:0510399958 03.10.2016 Defer Date: 15.02.2017 Decision :Deferred. 496 Case No.:98/16/82-ALC4/2016 Party Name:INDO PHYTO CHEMICALS PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00915/AM17/ RLA File :05/23/040/00293/AM17/ Lic.No/Date:0510400012 04.10.2016 Defer Date: 15.02.2017 Decision :Deferred. 497 Case No.:114/16/82- ALC4/2016 PVT.LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00931/AM17/ RLA File :05/23/040/00315/AM17/ Lic.No/Date:0510400010 04.10.2016 Defer Date: 15.02.2017 498 Case No.:117/16/82- ALC4/2016 PVT.LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred

HQ File :01/82/050/00934/AM17/ RLA File :05/23/040/00316/AM17/ Lic.No/Date:0510400011 04.10.2016 Defer Date: 15.02.2017 499 Case No.:17/16/82-ALC4/2016 Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00834/AM17/ RLA File :05/23/040/00322/AM17/ Lic.No/Date:0510400064 06.10.2016 Defer Date: 15.02.2017 500 Case No.:3/16/82-ALC4/2016 Party Name:DIVIS LABORATORIES LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00820/AM17/ RLA File :09/24/040/00346/AM17/ Lic.No/Date:0910064248 06.10.2016 Defer Date: 15.02.2017 501 Case No.:5/16/82-ALC4/2016 Party Name:DIVIS LABORATORIES LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00822/AM17/ RLA File :09/24/040/00363/AM17/ Lic.No/Date:0910064249 06.10.2016 Defer Date: 15.02.2017 502 Case No.:62/16/82-ALC4/2016 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00879/AM17/ RLA File :05/24/040/00285/AM17/ Lic.No/Date:0510400053 06.10.2016 Defer Date: 15.02.2017 Decision :Deferred. 503 Case No.:88/16/82-ALC4/2016 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00905/AM17/ RLA File :05/24/040/00206/AM17/ Lic.No/Date:0510400054 06.10.2016 Defer Date: 15.02.2017 Decision :Deferred. 504 Case No.:116/16/82- ALC4/2016 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00933/AM17/ RLA File :05/24/040/00237/AM17/ Lic.No/Date:0510400057 06.10.2016 Defer Date: 15.02.2017 Decision :Deferred. 505 Case No.:143/16/82- Party Name:ARJUN Meet No/Date:16/82- Status:

ALC4/2016 CHEMICALS PVT LTD ALC4/2016 28.12.2016 Deferred HQ File :01/82/050/00960/AM17/ RLA File :04/24/040/00118/AM17/ Lic.No/Date:0410162358 07.10.2016 Defer Date: 15.02.2017 Decision :Deferred. 506 Case No.:68/16/82-ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00885/AM17/ RLA File :05/23/040/00299/AM17/ Lic.No/Date:0510400077 07.10.2016 Defer Date: 15.02.2017 Decision :Deferred. 507 Case No.:73/16/82-ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00890/AM17/ RLA File :05/23/040/00298/AM17/ Lic.No/Date:0510400076 07.10.2016 Defer Date: 15.02.2017 Decision :Deferred. 508 Case No.:118/16/82- ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00935/AM17/ RLA File :05/24/040/00334/AM17/ Lic.No/Date:0510400083 07.10.2016 Defer Date: 15.02.2017 509 Case No.:75/16/82-ALC4/2016 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00892/AM17/ RLA File :05/24/040/00125/AM17/ Lic.No/Date:0510400069 07.10.2016 Defer Date: 15.02.2017 Decision :Deferred. 510 Case No.:79/16/82-ALC4/2016 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00896/AM17/ RLA File :05/24/040/00277/AM17/ Lic.No/Date:0510400073 07.10.2016 Defer Date: 15.02.2017 Decision :Deferred. 511 Case No.:101/16/82- ALC4/2016 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00918/AM17/ RLA File :05/24/040/00115/AM17/ Lic.No/Date:0510400070 07.10.2016 Defer Date: 15.02.2017 Decision :Deferred.

512 Case No.:55/16/82-ALC4/2016 Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00872/AM17/ RLA File :22/24/040/00060/AM17/ Lic.No/Date:2210015578 10.10.2016 Defer Date: 15.02.2017 513 Case No.:74/16/82-ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00891/AM17/ RLA File :05/23/040/00323/AM17/ Lic.No/Date:0510400088 13.10.2016 Defer Date: 15.02.2017 Decision :Deferred. 514 Case No.:129/16/82- ALC4/2016 Party Name:AMANTA HEALTHCARE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00946/AM17/ RLA File :08/24/040/00273/AM17/ Lic.No/Date:0810138843 14.10.2016 Defer Date: 15.02.2017 515 Case No.:121/16/82- ALC4/2016 Party Name:BIO TECH OPHTHALMICS PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00938/AM17/ RLA File :08/24/040/00281/AM17/ Lic.No/Date:0810138874 18.10.2016 Defer Date: 15.02.2017 516 Case No.:126/16/82- ALC4/2016 Party Name:BIO TECH OPHTHALMICS PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00943/AM17/ RLA File :08/24/040/00278/AM17/ Lic.No/Date:0810138860 18.10.2016 Defer Date: 15.02.2017 517 Case No.:127/16/82- ALC4/2016 Party Name:BIO TECH OPHTHALMICS PVT LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00944/AM17/ RLA File :08/24/040/00280/AM17/ Lic.No/Date:0810138861 18.10.2016 Defer Date: 15.02.2017 518 Case No.:107/16/82- ALC4/2016 Party Name:DALAS BIOTECH LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00924/AM17/ RLA File :05/23/040/00474/AM16/ Lic.No/Date:0510400138 18.10.2016 Defer Date: 15.02.2017

519 Case No.:20/16/82-ALC4/2016 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00837/AM17/ RLA File :05/23/040/00339/AM17/ Lic.No/Date:0510400130 18.10.2016 Defer Date: 15.02.2017 520 Case No.:54/16/82-ALC4/2016 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00871/AM17/ RLA File :22/24/040/00065/AM17/ Lic.No/Date:2210015580 18.10.2016 Defer Date: 15.02.2017 521 Case No.:108/16/82- ALC4/2016 SCIENCES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00925/AM17/ RLA File :05/23/040/00303/AM17/ Lic.No/Date:0510400129 18.10.2016 Defer Date: 15.02.2017 Decision :Deferred. 522 Case No.:89/16/82-ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00906/AM17/ RLA File :05/24/040/00321/AM17/ Lic.No/Date:0510400153 19.10.2016 Defer Date: 15.02.2017 523 Case No.:120/16/82- ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00937/AM17/ RLA File :08/24/040/00288/AM17/ Lic.No/Date:0810138919 20.10.2016 Defer Date: Decision : The Committee decided to ratify norms based on earlier decision taken by NC in its meeting No.04/82 dated 03.07.2014, 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. 524 Case No.:26/16/82-ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00843/AM17/ RLA File :31/83/040/00055/AM17/ Lic.No/Date:3110066375 20.10.2016 Defer Date: 15.02.2017 Decision :Deferred. 525 Case No.:113/16/82- Party Name:KLJ Meet No/Date:16/82- Status:

ALC4/2016 ALC4/2016 28.12.2016 Deferred HQ File :01/82/050/00930/AM17/ RLA File :05/23/040/00346/AM17/ Lic.No/Date:0510400173 20.10.2016 Defer Date: 15.02.2017 Decision :Deferred. 526 Case No.:80/16/82-ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00897/AM17/ RLA File :05/24/040/00344/AM17/ Lic.No/Date:0510400193 20.10.2016 Defer Date: 15.02.2017 527 Case No.:53/16/82-ALC4/2016 Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00870/AM17/ RLA File :22/24/040/00066/AM17/ Lic.No/Date:2210015582 21.10.2016 Defer Date: 15.02.2017 528 Case No.:87/16/82-ALC4/2016 Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00904/AM17/ RLA File :05/23/040/00287/AM17/ Lic.No/Date:0510400238 24.10.2016 Defer Date: 15.02.2017 Decision :Deferred. 529 Case No.:13/14/82- ALC4/2016 Party Name:ARIHANTANAM LIFECARE PVT. LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00811/AM17/ RLA File :52/24/040/00047/AM17/ Lic.No/Date:5210042055 25.10.2016 Defer Date: 15.02.2017 530 Case No.:86/16/82-ALC4/2016 Party Name:HELLO PAINTS (P) LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00903/AM17/ RLA File :05/23/040/00351/AM17/ Lic.No/Date:0510400251 25.10.2016 Defer Date: 15.02.2017 Decision :Deferred. 531 Case No.:51/16/82-ALC4/2016 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00868/AM17/ RLA File :22/24/040/00067/AM17/ Lic.No/Date:2210015583 25.10.2016 Defer Date: 15.02.2017

532 Case No.:67/16/82-ALC4/2016 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00884/AM17/ RLA File :05/24/040/00355/AM17/ Lic.No/Date:0510400261 25.10.2016 Defer Date: 15.02.2017 Decision :Deferred. 533 Case No.:102/16/82- ALC4/2016 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00919/AM17/ RLA File :05/24/040/00318/AM17/ Lic.No/Date:0510400258 25.10.2016 Defer Date: 15.02.2017 Decision :Deferred. 534 Case No.:122/16/82- ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00939/AM17/ RLA File :08/24/040/00289/AM17/ Lic.No/Date:0810138976 26.10.2016 Defer Date: 15.02.2017 535 Case No.:123/16/82- ALC4/2016 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00940/AM17/ RLA File :08/24/040/00307/AM17/ Lic.No/Date:0810138972 26.10.2016 Defer Date: 15.02.2017 536 Case No.:10/16/82-ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00827/AM17/ RLA File :31/83/040/00098/AM17/ Lic.No/Date:3110066386 26.10.2016 Defer Date: Decision : The Committee decided to ratify norms 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 537 Case No.:115/16/82- ALC4/2016 Party Name:KLJ Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00932/AM17/ RLA File :05/23/040/00329/AM17/ Lic.No/Date:0510400281 26.10.2016 Defer Date: 15.02.2017 Decision : Deferred. 538 Case No.:19/16/82-ALC4/2016 Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:16/82- ALC4/2016 Status: Deferred

28.12.2016 HQ File :01/82/050/00836/AM17/ RLA File :05/23/040/00355/AM17/ Lic.No/Date:0510400295 27.10.2016 Defer Date: 15.02.2017 539 Case No.:130/16/82- ALC4/2016 Party Name:IOL CHEMICALS AND PHARMACEUTICALS LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00947/AM17/ RLA File :30/24/040/00027/AM17/ Lic.No/Date:3010103875 27.10.2016 Defer Date: 15.02.2017 540 Case No.:52/16/82-ALC4/2016 Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00869/AM17/ RLA File :22/24/040/00038/AM17/ Lic.No/Date:2210015587 27.10.2016 Defer Date: 15.02.2017 541 Case No.:14/14/82- ALC4/2016 Party Name:CONCORD BIOTECH LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00812/AM17/ RLA File :08/24/040/00264/AM17/ Lic.No/Date:0810138999 28.10.2016 Defer Date: 15.02.2017 542 Case No.:66/16/82-ALC4/2016 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00883/AM17/ RLA File :05/24/040/00339/AM17/ Lic.No/Date:0510400305 28.10.2016 Defer Date: 15.02.2017 Decision :Deferred. 543 Case No.:71/16/82-ALC4/2016 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00888/AM17/ RLA File :05/24/040/00360/AM17/ Lic.No/Date:0510400306 28.10.2016 Defer Date: 15.02.2017 Decision :Deferred. 544 Case No.:11/16/82-ALC4/2016 Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00828/AM17/ RLA File :31/83/040/00094/AM17/ Lic.No/Date:3110066388 31.10.2016 Defer Date: 15.02.2017

545 Case No.:18/16/82-ALC4/2016 Party Name:HONOUR LAB LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00835/AM17/ RLA File :09/24/040/00417/AM17/ Lic.No/Date:0910064330 31.10.2016 Defer Date: 15.02.2017 546 Case No.:15/14/82- ALC4/2016 Party Name:MICRO LABS LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00813/AM17/ RLA File :07/24/040/00255/AM17/ Lic.No/Date:0710110609 02.11.2016 Defer Date: 15.02.2017 547 Case No.:16/14/82- ALC4/2016 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status:Deferred HQ File :01/82/050/00814/AM17/ RLA File :04/24/040/00133/AM17/ Lic.No/Date:0410162482 10.11.2016 Defer Date: 15.02.2017 548 Case No.:64/16/82-ALC4/2016 Party Name:BALAJI AMINES LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00881/AM17/ RLA File :31/83/040/00103/AM17/ Lic.No/Date:3110066396 15.11.2016 Defer Date: taken by NC in its meeting No.4/82 dated 03.07.2014, 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 549 Case No.:65/16/82-ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00882/AM17/ RLA File :31/83/040/00106/AM17/ Lic.No/Date:3110066397 15.11.2016 Defer Date: 15.02.2017 Decision :Deferred. 550 Case No.:134/16/82- ALC4/2016 Party Name:ARIHANTANAM LIFECARE PVT. LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred HQ File :01/82/050/00951/AM17/ RLA File :52/24/040/00054/AM17/ Lic.No/Date:5210042082 05.12.2016 Defer Date: 15.02.2017 551 Case No.:135/16/82- ALC4/2016 Party Name:ARIHANTANAM LIFECARE PVT. LTD. Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Deferred

HQ File :01/82/050/00952/AM17/ RLA File :52/24/040/00055/AM17/ Lic.No/Date:5210042083 05.12.2016 Defer Date: 15.02.2017 552 Case No.:144/16/82- ALC4/2016 Party Name:SRIAM LABS PRIVATE LIMITED Meet No/Date:16/82- ALC4/2016 28.12.2016 Status: Approved HQ File :01/82/050/00961/AM17/ RLA File :09/24/040/00502/AM17/ Lic.No/Date:0910064500 21.12.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/757/2015-PI(Norms) dated 02.05.2016, uploaded Manual Agenda of NC Meeting No.16/82/2016 Scheduled to be held on 28.12.2016 but actually held on 31.01.2017 Case No. B- 01 M.No.16/AM-17 Date 28.12.2016 M/s. Enaltec Labs Pvt Ltd File No.01/82/50/00705/AM-17 RLA No.03/94/040/00361/AM17 Adv.Auth. No. 0310806885 dated 05.08.2016 File No.01/82/50/001820/AM-16 RLA No.03/94/040/00906/AM16 Adv.Auth. No. 0310802288 dated 08.02.2016 Decision: The Committee considered this case for correction in import item description as per agenda. The Committee decided to correct the description of import item as the decision of NC taken in its meeting No.14 dated 24.10.2013, uploaded as the end of these minutes or as applied by the firm whichever is less. RA concerned may take necessary action as per the decision of NC. Case No. B- 02 M.No.16/AM-17 Date 28.12.2016 M/s. Mecleods Pharmaceuticals Ltd File No.01/82/50/00445/AM-15 RLA No.03/95/040/01010/AM14 Adv.Auth. No. 0310774159 dated 12.03.2014 Decision: The Committee considered this case for amendment of norms as per agenda. The Committee decided to examine the case on file. Case No. B- 03 M.No.16/AM-17 Date 28.12.2016 M/s. Huberoup India Pvt Ltd File No.01/82/50/00092/AM-17 RLA No.03/94/040/01004/AM16 Adv.Auth. No. 0310803038 dated 03.03.2016 Decision:The Committee considered this case for correction spelling in description of import item as per agenda. The Committee decided to correct description of import item to read as “Pentaerythritol”. RA may take further necessary action as per decision of NC.

Case No. B- 04 M.No.16/AM-17 Date 28.12.2016 M/s. Catapharma Chemicals Pvt Ltd File No.01/82/50/00566/AM-14 RLA No.31/83/040/00054/AM14 RLA No.31/83/040/00232/AM14 RLA No.31/83/040/00115/AM14 Adv.Auth. No. 3110060069 dated 23.08.2014 Adv.Auth. No. 3110063312 dated 28.03.2014 Adv.Auth. No. 3110064753 dated 19.08.2014 Decision: The committee considered this case for revision of norm as per agenda. The Committee decided to examine this case. The Committee also decided to send a complete set of application and representation of firm to DoP for their comments. The Committee accordingly deferred the case. Case No. B- 05 M.No.16/AM-17 Date 28.12.2016 M/s. Alcon Biosciences Pvt Ltd File No.01/82/50/00925/AM-11 RLA No.03/94/040/00472/AM11 Adv.Auth. No. 0310595543 dated 06.10.2010 Decision: The committee considered this case for ratification of norm as per agenda. The Committee decided to examine this case on file and also send a complete set of application and representation of firm to DoP for their comments. The Committee accordingly deferred the case.

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形 一 成 ハ Date: 7.12.2012 No.:29/3ノ82‐ALC4/2012 Party Name:PORUS Meet No/Date:27/82- LABORATORIES PVT LTD. Lic.No/Date:0910051178 :01/82/050/00033/AM 13/ :09/24/040/00521/AM 12/ 09.02.2012 Decision :Comrnittee consldered case as per agenda and ln iight of written comrnents forwarded by Department of C&PC vlde their F No.No.46011/77ノ2012‐ PC‐‖dated 18.12.2012, declded to ratify norms under para 4 7 of HBP as per details below or as applied by lrm whicheveris lower‐ Export product Exp Qty SI.No. lmport items Qtv. allowed C884083 - Capped O.09 iV BiFUNCT:ONAL PPO l Kg 1 Mx 90/SA90-100-0‐ 50ST 1 53 kg 2 METHACRYL!C ANHYDR!DE/MAAH 0.32 kg 3. 4-DIMETHYL AMINO PYRIDINE 0 02 kg RA concerned may take further necessary action as per above decision of NC

¬ | Case No.:73ノ40′82‐ALC4r2010 1禍訥雷漸掛 D, Meet NoノDate:6/82‐ ALC4/2011 10.05.2011 ｅ ｕ ｓ ‥ Ｃ ａ ｒ ｏ ｖ ｅ ｄ Ｓ ｔ ａ ｔ 柳 1 lQ Fi!e:01ノ82r050/01272rAMll′ RLA File:17ノ24/040/00086/AM09ノ ¨ic,NoノDate:1710003611 '4.12.2010 Decision:Committee considered case as per agenda and in light of written comrnents fon″ arded by Department o Э&PC vide their U.0. No.14010ノ35/2010・Ch.‖ dated 20.04.201l and in consultation with technical authori、 Эresent in meeting, decided to rati″ normS under para 4.7 of HBP as per detai!s below or as app‖ ed by l「IT 〃hichever is:ower:‐ Export Product ExpOn Qty. SI.No. lmport items Qtv a!:owed Product― ssP-20 (POlyOXyethylene 20,Sorbitan Monolaurte/Sorbitan Monolaurate 20 Mole Ethoxv!ate) l KG. Ethyl oxide(CO10u‖ ess ciear liquid) 0.707 kg RA concemed may take further necessary action as per above decision of NC. ギ Page I of I http://dgft.gov.in/exim/2000/committee/meet adv4-06 1 2.htm 10‐01‐2017

⌒ |__ 獨 93__´ 「 ~ i_Nastttllibた 挑透_Aic4/201i 'any｀lI:JubiLAヽ十二iFЁ 'M8よヽあ 轟145/j2‐ …… ヽ1裏玉薫男凛 ～ | : I SCIENCES LIMITED IALC4/20H :Approved l l : |(FORMERLY JUBILANT 07.022012 1 1 : 輌Q Flざ ~… ~… … …~~ ― ^‐ 薫働請1… … … … ｀ Lおヽルbttbζ ib'884シ ‐~残 :ぷb品 「 ~: Defer Date: 1 111マ ■ 11し 1・ ｀ル｀ ・ `・▼ |~~~ | |:01/82/050/00112/ANl12/ 105/23/040/00007/Aヽ412/ 120042011 1 ‐ IDecision : The Colllrnittee considered the case as per agenda and in light of 、vritten l comments received from Department of Chcmicals and Pctrochemicals vide their U.O No. 1 14010/38/2011-Ch H dated 10.2.2012 2012and in consuLalon wtth technical authonty presentin l imeetingi decided to raufy nOrms under para 4 7 of HBP as per detalis below or as applied by lrm | lwhiCheveris lower 11 Export Product Exp. Qty. S,No Import Item Qty. aHo、ved/kg 2-Chloro-6- Trichloromethyl Pyridine l kg l 2 3 4 5 Alpha Picoline 1,2,4 -T richlo roben ze n e Heptane Stergene Carbon 0.658 kg O.220 kg O.280 kg O.006 kg O.005 kA RA mav take appropriate action as per the decision of Norms Committee' may appropriate ― : ― ― 一

鰤…側州Ⅳ→″ Goverllment oflndia 一 ノι 一わ Ministry of Chemical & Fertilizers Department of Pharmaceutical s Udvoe Bhawan, New Delhi, tne I LhP ebri:ary, 20 1 5 Office Memorandum Sub: Fixation of norms under para4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s. Kores India Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501568/AMl5/DES-3/498 dated the 02109114 vide which an application from M/s. Kores India Ltd was sent to this Department fbr fixation of norms under para: 4.7 for the export of 2 Methyl Benzhdryl Chloride. This department has examined the matter and the following comments are furnished under para4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S,No. Import Item Qty. Recommended kglkg. l Sodium Borohydride 0.l12 つ ４ 2 Methyl Benzophenone 1.126 This issues with the approval of Director (PI). Under Secretary to the Government of India Phone- 23071162 Directorate General of Foreign Trade, Departmcnt of Commerce, (Shl・iM.V.Singh,FTDO), Udyog Bhawan,New Dclhi (BI∬躙 ) } ■襲 ヾ 増

孝 F. No.350l l/61012012-Pl (Norms) Govemment of India Department of Pharmaceuticals Udyog Bhawan, New Delhi, the 06s FebruarY,20l3 Qffice Me.morandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (vol.l) 2009-14 case of M/s. Softgel Healthcare Pvt Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501004891AM13/DES- 31632 dated the 27/08112 vide which an 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 Bioglan CO Q10 50 softgelatin capsules (6 Export ltem). This department has examined the matter and the following comments are fumished under para 4.7 of Hand Book of Procedures (Vot.l) 2009- l4- 2. This issues with the approval of Director (Cost). (N.N.Ahuja) Section Offrcer PI-Norms Department of Commerce, (Mrs. Latita Maini, FTDO), Udyog Bhawan, New Delhi. SI No Export Item Quantity (Nos) Raw Material Quantity recommended. 1 Capsules Bioglan CO Ql0 50 l Lakh Co-enzyme Ql0 5.100 kgs う ｚ Capsules Aspacardio Q l0 -do- ― do‐ 3.06 ヽ ン /3 Capsules Aspacardio Q l0 extra forte -do- -do- 5100 / Capsules Aspacardio mix omega 3+Q l0 -do- -do- 10200 5 Caosules myoga Q l0 ―do‐ -do- 10200 6 Capsules CO Q l0 100 ― do‐ ‐ do― 10200

F. No.350 1 1 1437 1201 s-Pl (Norms) Government of lndia Department of Pha rmaceuticals Udyog Bhawan, New Delhi, Dated: August, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case of M/s Alchem lnternational (P) Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501539/AM- 16/DES-3/610 dated the 1517115 vide which application from M/s Alchem lnternational (P) Ltd. 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.l) 2009-14:- S.No. lmport item Norms Recommended Digitalis Lanata Leaves 266.64kglkg Digoxin export 2. This issues with the approval of competent authority. (Rajkumar) Under Secretary to the Government of lndia PH:- 23071162 (Shri M.V. Singh, FTDO), Udyog Bhawan, New Delhi.

F. No.350 1 1 17831201 5-Pl (Norms) Government of lndia 〆 一 ´ Shastri Bhawan, New Delhi, Dated the August 22,2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14: Application from M/s Encube Ethicals P\r't. Ltd. The undersigned is directed to refer to DGFT U.O. No. 011821050/01378/AM-16/DES- 31502 dated 1210112016 vide which an application from M/s Encube Ethicals Pvt. Ltd was sent to this Department for fixation of norms for the export of 31 type of packs of ointments/creams. 2) The matter has been examined and all these 31 export products have been categorized in 17 groups of ointments under different brands/generic formulations. The norms for each of the categories for different pack sizes have been worked out based upon DML, Batch Formula and SION published for this type of formulations. The quantities of different inputs for 100 tubes of different pack sizes of specific composition of formulations as given below may be considered as input output norms for the export products covered under this application. S.N 0 Name of Export Product Ｎ Ｓ ） ０ lnputs recommended 100 tubes of14 gm 100 tubes of 42 gm 100 tubes of28 gm 1 Miconazol e 2o/o Creams in different pack sizes Benzoic Acid 0.28 gm 0.84 gm 0.56 gm 2. Peqoxvl 7-stearate 280 gm 820 om 560 gm 3. Ⅳlineral()il 42 gm 126 gm 84 gm 4. Oleovl Polvoxvlq lvcerides 42 gm 126 gm 84 gm 5. Butvlated hvd roxvan isole 0.0728 om 0.2184 gm 0。1456 gm 6. Miconazole 28.56 gm 85.68 gm 57.12 gm 7 Empty Laminated Printed tubes of corresponding sizes As per Packing Policy Ｎ Ｓ ） ０ Name of Export Product S.N O lnputs recommended 100 tubes of 45 gm with 1 apolicator 100 tubes of 45 gm with 7 applicators 2 Miconazole 2% Creams Benzoic Acid 0.900 gm 0,900 gm 2 Peqoxyl 7-stearate 900 om 900 gm 3. Mineral()il 135 gm 135 om 4. Oleoyl Polyoxylqlycerides 135 gm 135 gm 5. Butvlated hydroxyanisole 0.234 gm 0.234 gm 6. Miconazole 91.80 gm 91.80 gm 7. Empty Laminated Printed tubes of corresponding sizes As per Packing Policy 8. 1 or 7 applicators as per product specification 100 packs of one applicator each 100 packs of Seven applicator each

-2- S.No Name of Export Product S.No lnputs recommended 100 tubes of 14 gm 100 tubes of 28 gm 3 Clotrimazole 1% creams Cetostearyl Alcohol 140 gm 280 om 2 Octyldodecanol 189 gm 378 gm 3. Cetyl Esters 33 gm 66 gm 4. Sorbitan Monostearate 28 gm 56 gm 5. Polysorbate 60 21 gm 42 gm 6. Clotrimazole 14.28 gm 28.56 gm 7. BenzylAlcohol 14 gm 28 gm 8. Sodium Phosphate Monobasic 2.24 gm 4.4 gm 9. Empty Laminated Printed tubes of corresponding sizes As per Packing Policy S.No Name of Export Product S.No lnputs recommended 100 tubes of45 gm with l app!icator 100 tubes of 45 gm with 7 applicators 4 Clotrimazole 1% creams Plastic (LDPE) Applicators (1s or 7s packs) (100 pack of1 applicator each) (100 pack of 7 applicators each) 2 Cetostearyl Alcohol 450 gm 450 om 3. Octyldodecanol 607.50 gm 607.50 om 4. Cetyl Esters 135.00 om 135.00 gm 5. Sorbitan Monostearate 90.00 gm 90.00 om 6. Polysorbate 60 67.50 gm 67.50 om 7. Clotrimazole 45.00 gm 45.00 om 8. BenzylAlcohol 45.00 om 45.00 om 9. Sodium Phosphate Monobasic 7.20 om 7.20 gm 10. Empty Laminated Printed tubes of corresponding sizes As per Packing Policy

影 夕 ^ ノι 一ス5 Meet No/Date:35/82- ALC4/2011 29112011 ｅ Ｓ ａ ｄ ｕ ｓ ‥Ｃ ｒ ｏ ｖ ｅ Ｓ ｔ ａｔ Ａ ｐ ｐ 0510304814 ision : Committee considered case as per agenda and in light of written comments fonivarded by artment of C&PC vide their U.O. No.14010188t2004-Ch.lll dated 27.10.2008 and in consultation technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per ils below or as applied by firm whichever is lower:- Export product Exp. Qty. SI No lmport items Qtv. allowed Thymol (Purity 98.5% Min.) l Kg Meta Cresol 0 785 kg RA concerned may take further necessary action as per above decision of NC. | ICase No.:27ノ35′ 82‐ : :ALC4′ 2011 IParty IRLA Fi!e /AM12/ 1:05/24/040/00224/AM12/ /82/050/00954/AM12/ 105/24/040/00224/AAl11 2/ 10102011

七髪 Pa●y Namei CONSTECH ENTERPRISES PVT LTD 簿O ile‐ ~‐ ~… … :RLAI五3・ … …… … 二おヽjbttbち16jζ 541i わ湯群b五iよ ::01/82/050/00518/AM14/ ::05/23/040/00117ハM14/ 110072013 i Decision : ln the light of written comments received from Department of Chemicals and Petrochemicals vide their U O No.14010/48/20112/Ch‖ dated ol ll.2013′ it was decided to ratify norms under Para 4 7 of HBP vl as per deta‖ s given belov″ or as applied by the firm′ whichever is less: Export Product Export Quantity S No lmport Product QuantitY Allowed 2,4-DIMETHYL-6- TERBUTYLPHENOL l kg 2.4-XYLENOL 0 796 kg ISOBUTYLENE 0 366 kg CATALYST As the details of catalyst not available, so not recommended may take appropriate action as per the decision of Norms Committee' Case No.:42/13/82‐ ALC4/2013 Meet No/Date:15/82-

^ エ 3g IRLA F‖e Lic No/Date:3410038488 1Defer Date: :34/24/040/00202/AM14/ .20.H.2013 . IHQ File l:01/82/050/01158/AM14/ Case No.:111/23/82‐ CHINTAN PHARMA CHEM PVTIンTD ALC4/2014 108.05.2014 Decision : In the li1 Petrochemicals vid decided to ratify nor by the firm, whiche. ght of written cOmnlents received frOrn Department of Chemicals and e their U.O No. 14010/99/2012‐ Ch II dated 09.05。2013, it 、vas Ens under Para 4.7 of HBP vl as pcr details givcn be10、v or as applied ver is less: Export product Exp.Qty. SI.No. lmport items Qty. allowed MethyI Tributy! Ammonium Chlonde CAS No.56375-79-2 Assay 75%(=/-2%) l kg 1 Tributylamine 0.625 kg may take appropriate action as per the decision of Norms Committee. No/Datc:3/82-

ハ :よ:L面 :":′ L/8'I P:たvN:ふさ :ム面十百三Å IMきき 1ヽ8,6:1き:i」/8': ISi:1薇:Åお 161さ b ヽLC4/2012 1AROMATiCS PVT LTD.′ 'ALC4/2012 1 117072012 1 lQ File RLA File l日 c No/Date:0310689105 1Defer Date: 01/82/050/00218/AいИ13/ 103/94/040/00859/AM12/ 130.032012 1 )ecision:Conlmittee considered case as per agenda and in light of w「 itten comments fon″ arded by Deptt Of C&PC vide their U O No 14010/55/2011‐ Ch ll dated 10 07 2012 and in consu!tation with iechnical authority present in meeting,decided to ratify norms under para 4 7 of HBP as per detai!s Эelow or as applied by firm whicheveris loweri― Export product Exp Qty Ｌ 　 Ｏ Ｓ Ｎ lmport items Qty. allowed Tricyclodecanone Ketone Nlin.93.50% l kg Dicyclopentadiene Min 90% 1 15 kg/kg ssary action as per above decision of NC :297

⌒ 16 `И 3q Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/3712014-Ch II dated 21.05.2014, it was decided Pctrochcnlicals vide their I」.O No. 14010/37/2014-Ch II dated 21.05.2014,it was deci to ratify nolllls under Para 4.7 of HBP vl as per details given below Or as applied by f11111,whichcver is less: Export product Exp. Qty. SI.No. lmport items Qtv. allowed TCPC‐ CAT‐ 18(METHYL TRIOCTYL AMMONIUM CHLORIDE) METHYL TRI(C‐ 8,C‐ 10)ALKYL AMMONIUM CHLORIDE CAS No. 63393‐96‐4 ASSAY 88‐ 92% l kg ALAMINE336 or TRI Octy1/Dccyl Aminc T面 (C‐ 8,C‐ 10)ALKYL AMINE 0 845 kg thc ｎ ン ICase No.:7/17/82‐ ALC4/2013 Pa“y Name:TATVA IMeet No/Date:3/82‐ Status:Case l lCHINTAN PHARMA CHEM IALC4/2014 1Approved l l IPVT LTD o8.05.2014 1 1 」

F. No.350I II14112015-PI (Norms) Government of India Ministry of Chemicals & Fertilizers -r9 SLI Udyog Bhawan,New Delhi, Dated the October, 2015 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s Morepen Labs Ltd. The undersigned is directed to referto DGFT U.O.No. 01182150/1478/AM-L51DES-3/1318 dated the 05103115 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 norrns are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S. No. Import Item Qty. Recommended kg/kg. 1 1-Fluoro-Alpha- [2-Methyl- I -Oxopropyl] -Gamma- 0xo-N-Beta-Diphenyl Benzene Butanamide 0.994 2. [2R-Cis)- 1, I -Dimethylethyl-6-Cyanomethyl-2,2- Dimethyl- I ,3 -Dioxane-4-Acetate 0,708 3. Methylene Chloride 4.354 4. Diisopropyl Ether 3.791 (Barnali Khastgir) Under Secretary to the Govemment of India Phone:23071162 Udyog Bhawan, New Delhi

エ ィ 一 Ｆ Ｉ … … ‐ No/Date:3/82- 14 14 IHQ File :01/82/050/00024/AM15/ IRLA File l:05 124 1040 100386 I AMI 4 I :Lic.No/Date:0510376976 1Dcfer Date: | 124.01.2014 つ ４ Decision : ln the light of written comments received from Department Of chemicals and Petrochemicals vide their U.O No.14010/18/2014-Ch.‖ dated 28.05.2014′ it was decided to ratify norms under para 4.7 of HBP vl as per detalls g市 en below or as applied by the irm′ whicheveris less: Export product Export Quantity S.No. Import items Quantity Allowed DI OCTYL TERAPHTHATATE(DOTP) l kg 1 PURE TERE PHTHALIC ACID 0.447 kg つ ん 2‐ETHYL HEXANOL 0.680 kg No.:20/3/82‐ ALC4ノ2014 Name:PAYAL

μ ´ “ F. No. 3501 1 /7081201 s-Pl (Norms) Government of lndia Shastri Bhawan, New Delhi, Dated: March 17,2016 Office Memorandum Sub: - 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. 01/82I50/00984/AM-16/DES-3 /1 133 dated the 2611112015 vide which an application from M/s J.B. Chemicals & Pharmaceuticals Ltd was sent to this Department for fixation of norms against export of Bio-Streptomycin Sulphate lnjection 1 gm in 3 ml vials. 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:- Product to be Exported Raw materials to be lmported Description Quantity Description Quantity Bio-Streptomycin Sulphate lnjection 1 gm in 3 ml vials One Vial of 3 m: Streptomycin Sulphate Sterile 13789m 2. This issues with the approval of Director (Pharma lndustry). (Raj Kumar) Under Secretary to the Government of lndia Phone: 23071'162 Uspi3-Pharma@nic.in Directorate Genera:of Foreign Trade, (shn M v singh,FTDO), Udyog Bhawan,New Delhi

F. No.350 1 | l30l 12015-PI (Norms) Government of India Ministry of Chemicals & Fertilizers Department of Pharmaceutical s Dated the October, 2015 Offrce Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s Dr. Reddy's Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 0ll82l50ll3l5lAM-15/DES-3/88 dated the 16106115 vide which application from M/s. Dr. Reddy's Labs Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Nise GeUNise Gel Plus-20g. This department has examined the matter and the following norrns are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S. No. Import Item Qty. Recommended. 1 Capsaicin 5.lmgl2}gm pack (Barnali Khastgir) Under Secretary to the Govemment of India Phone:23071162 .!! "

l6

w7 F. No.350 1 I I 545 12012-PI (Norms) Government of India Udyog Bhawan, New Delhi,the2Tth December, 2012. Office Memorandum Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case of M/s Agio Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 0ll82l50l22ll{Ml3lDBs-31374 dated the 30/05/12 vide which an application from M/s Agio Pharma Ltd was sent to this Department for fixation of norms under para; 4.7 for the export of Bendaz 10%. This department has examined the matter and the following comments are furnished under para4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S. No. Export Item Imports Recommended for 1No. Albendazole 1 Albendazole l0o/o Suspension (l 000m1) 0.102 kg/Bottle 2 Albendazol e 2.5o/o Suspension ( 1 000m1) 0.0255 kg/Bottle 3 Albendazole Bolus 600 mg 612 mg/Bolus 4. Albendazole Bolus 1500 mg 1530 mg/Bolus 5. Albendazole Bolus 2500 mg 2550 mg/Bolus 6. Albendazole 600 mg+Oxyclozanide 300 mg Tablets 612 mg/Tablets 7 Albendazole 360 mg+Oxyclozanide 175 mg Tablets 361.2 mg/Tablets 2. (N.N.Ahuja) Section Officer PI-Norms (Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi.

No:33/14/82- |` ウ concerned may take further necessary action as per above decision of NC. Decision : Committee considered case as per agenda and in light of written comments fonruarded by of C&PC vide their U O No 14010/11/2010-Ch:l dated 05 04 2010 and in consu!tation technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per below or as applied by firm whichever is lower:-

F. No.350 l 1 120412013-PI (Norms) Government of India Udyog Bhawan, New Delhi, the 03th July, 2013 Office Memorandum Subject: - Fixation of norms under para4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s Granules India Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501985/AM13/DES-3/1 133 dated the 04102113 vide which an application from M/s. Granules India Ltd was sent to this Department for fixation of norrns under para: 4.7 for the export of Compresso Cotrim 90(Sulfamethoxazole and Trimethoprim Granules DC). This department has examined the matter and the following norns are fumished under para4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S. No. Import Item 1 Sulfamethoxazole 0.75 つ ４ Irimethoprim 0.l s 3. Pregelatinised Starch 0.043 4. Croscarmellose Sodium 0.040 5. Povidone K-30 0.006 6. Sodium Lauryl Sulfate 0.001 7. Stearic Acid 0.010 2. (Raj Kumar) PI-Norms (Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi.

F. No.350 1 I I 461 12015-PI Qrlorms) Government of India Department of Pharmaceutical s l6 66 New Delhi, the Udyog Bhawan, November,2015 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s Arene Life Sciences Ltd. The undersigned is directed to refer to DGFT U.O.No. 0ll82l50ll377lAM-16|DES-3/486 dated the 8l}7ll5 vide which application from M/s. Arene Life Sciences Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Gabapentin Hcl. This department has examined the matter and the following nonns are furnished under para4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S. No. Import Item 1 1,i -Cyclohexane Diacetic Acid 1.074 2. N-Butanol 0.583 3. Di Isopropyl Ether 1.167 2. (Raj Kumar) Phone:23071162 (Shd M.V. Singh, FTDO),

み Party NameiPAYAL POLYPLAStt PVT LTD, 鵬肌50/004刊;ヽⅢ2 騰蔦蕊鳥ly~ 02052011 as per above decision of NC. ． ¨ ｓ ｕ ‐ ｔ ａ ｔ ｉ 。 ｎ 『 　 　 「 may Case Noi5/7/82‐ALC4/2011 3::辮」fT躍 寵 雛 麗「∵ざで 1馳雷 躯:卵評 |‖ :蟹∬明捏12器T電:『γ W闇 習 wnh technical authonty present in meeting, decided to ratify norms under para 4 7 of HBP as l detalls below or as applied by firm whicheveris loweri― Export product I Export etv. SI No lmport items Qty. allowed Di-lso Butyl Phthalate lkg 1 Phthalic Anhvdrlde 0 560 kg 2. lso Butanol 0 560 kg concerned may take further action

lp 6/ F. No.3501 1 122612014-PI (Norms) Government of India Udyog Bhawan, New Delhi, the October,2014 Office Memorandum Subject: - Fixation of norms under para4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of Ir4/s Hetero Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. Oll82l50l1,233lAM-l4lDES-3/39 dated the 25104114 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 Losartan Potassium. This department has examined the matter and the following norns are fumished under pata 4.7 of Hand Book'of Procedures (Vol.l) 2009 -l 4- S. No. Import Item Qty. Recommended kgkg. 1 2-butyl-4-chloro-5 -formyl imidazole 0.50 2. l-bromo methyl-2-cyano biphenYl 0.866 3. Sodium borohydride 0.048 4. Ioluene t.45 5. Methanol 0.85 6. n-methyl pyrolidone 0.769 This issues with the approval of Director (Cost)' (Bamali Khastgir) (Shd M.V. Singh, FTDO),

t/; I- ...-1L F. No.350l l/99/2015-PI (Norms) Govemment of India Ministry of Chemicals & Fertilizers Dated the September, 2015 Qffice MenoranCum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of N4/s RA Chem Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 0l/82/50ll057lAM-15/DES- 3/1055 dated the l3101/15 vide which application from lr'{/s. RA chem Pharma Ltd was sent to this Department for fixation ofnorms under para: 4.7 for the export of Ractopamine Hcl. This department has examined the matter and the following norrns are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S. No. lmport ltem l -(4-Hydroxy Phenyl)-2-Amino Ethanol (Octopamine Hcl) 0.77 う ι 4-(4-Hydroxy Phenyl)-2-Butanone 091 ０ ， Methanol 1.87 4 Ethyl Acetate 2.44 (Bamali Khastgir) Phone:23071162

F. No.3 50 1 | 123812015-PI Qllorms) Govemment of India Ministry of Chemicals & Fertilizers エ マ多 Dated the September, 2015 Office Memorandum Subject: - Fixation of norms under para4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s Rakshit Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 0ll82l50lt\liAM-16/DES-3167 dated the 16106115 vide which application from M/s. Rakshit Pharma Ltd was sent to this Department for fixation of norrns under para: 4.7 for the export of Pantoprazole Sodium Or Pantoprazole Sodium Sesquihydrate. This department has examined the matter and the following norns are furnished under para4.7 of Hand Book of Procedures (Vol.l) 2009-14- S.No. Import Item 1 レIaltol 0。728 つ ４ Potassium Carbonate 0.824 3. ν〔ethylene Dichloride 4.73 4. Acetone 6.73 (Bamali Khastgi→ Under Secretary to the Goverlment oflndia Phone:23071162 DirectOrate Gencra1 0f Foreign Trade, Department of COmmcrcc, (Shri M.V.Singh,FTDO), Udyog Bhawan,Ncw Delhi

F. No.3 50 l 1 127 3 12015-PI (Norms) Government of India Ministry of Chemicals & Fertilizers Department of Pharmaceutical s JL 15 Datedthe September,20l5 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2OOg-14 Case of M/s Maharshi Pharma Pvt Ltd. The undersigned is directed to refer to DGFT U.O.No. 01l82l5Oll46lAM-|6IDES-3/l6l dated the 18106115 vide which application from M/s. Maharshi Pharma Pvt Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Beclomethasone Dipropionate. This department has examined the matter and the following norns are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S. No. Import Item Qty. Recommended kdkg. 1 (DB-XI) 9-Beta, I 1 -Beta-Epoxy- I 7-Alpha,2 1 -Dihydroxy- I 6-Beta Methylnepregna- 1,4-Diene-3,20-Dione 0.88 (Barnali Khastgir) Phone:23071162

だ マ F. No.350 l 1 1241 12015-PI (Norms) Govemment of India Ministry of Chemicals & Fertilizers Datedthe September,20l5 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 20Og-14 Case of M/s Maharshi Pharma Chem Pvt Ltd. The undersigned is directed to refer to DGFT U.O.No. Oll82l5Ol92lAM-l6lDES-3/107 dated the 16106115 vide which application from M/s. Maharshi Pharma Chem P\4 Ltd was sent to this Department for fixation of norms under para:4.7 for the export of Dexamethasone Sodium Phosphate. This department has examined the matter and the following norms are furnished under para4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S.No. Import Item 1 Dexamethasone 0.78 Under Sccrctary to the G」lliII]よli::I112 Phone:23071162 E)irectOrate Gcneral ofForcign Tradc, Department Of COmmercc, (Shri M.Vo Singh,FTDO), Udyog Bhawan,Ncw Delhi

〆 プ F No 35011ノ726ノ2015-PI(Norms) Government oflndia Ministry of Chemical&Fertilizers Dated: 28 April, 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s Maharshi Pharma Chem Pvt. Ltd. The undersigned is directed to referto DGFT U.O.No. 01l82lS0t624lAM-16IDES- 3i756 dated the 10/8/'15 vide which application from M/s Maharshi pharma chem pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of clobetasol Propionate. This department has examined the matter and the foliowing norms are furnished under para 4.7 of Hand Book of procedures (Vol.l) 2009-14:- 2 (Ralkumar) Under Secretary to the Government oflndia PH:-23071162 DirectOrate General of Foreign Trade, Depattment of COmmerce, (shn M v singh,FTDO), Udyog Bhawan,New Delhi S No lmport ltem Norms Recommended for 1kq Export 1 Betamethasone 1 00kg

⌒ ′ι 一移ス 110 Case No i43/14/82- IParty NameiBEST VALUE Meet No/Date:26/82- IStatus:Case ALC4/201l iCHEM PN/T LTD
‐ALC4/2011 1Approved 127092011 1 HQ F‖e lRLA F‖ e lLic No/Datei341 0030384 1 :01/82/050/00434/AM12/ :34/24/040/00027/AM12/ 26052011 1 Decision: i Committee considered case as per agenda and in iight of w「itten comments forwarded by Department of C&PC vide their U O No 14010/58/2011-Ch‖ dated 23 09 201l and in consultation with technica!authorities present in meeting, decided to ratify norms under para 4 7 of HBP as per deta‖ s below or as applied by fi「m whicheveris!oweri― Export product Exp. Qtv. S:No lmport items Qty. allowed Melonal l Kg Methyl Heptanone 1 125 kg 2 Ethyl Chloro Acetate 1 201 kg 3 Sodlum Methoxide 0 562 kg RA concerned may take further necessary action as per above decision of NC.

⌒ F.No.350H/153/2014-PI(NOrrns) Goverrmcnt oflndia 蹴脚:fl出競罵1燎 S Ncw Dclhi,the Udyog Bhawan, October,2015 SubiCCt:― Fi,atll:」 1:i:1』【 jII:1:T21:う :;:]F[帯llFttllittofProcedures(V01.1)2009-14 Case of 慰威i榊驚導f打轟整 i exanlincd the matter and the folloWing nollllS Procedures(VOl.1)2009-14:― (Bamali Khastgir) UndcrSecretarytOtheGoI:織 :ll」∫り }f:3 Directorate Gcnera1 0f Forcign Trade, Deprartmcnt Of COmFnCrCC, (Shri M・V・Singh,FTDO), UdyOg Bha、van,New Delhi Qty. Recommended. 1.75 kg/kg A u-.ytntomycin Base USP ydroxylamine Hcl :百扇藤粟雨lfonyl Chloride 1.00gnゴkg A Carbon (5%

F. No.350 11 13641201 s-Pl (Norms) Government of lndia Shasttt Bhawan,New Delhi, Dated the 30th November,2015 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14: Application fom M/s Shasun Pharma Limited. The undersigned is directed to refer to DGFT U.O.Nos. 011821501335/AM-16/DES- 3/310 & 011821501334/AM-16/DES-3/322 dated the 02107115 vide which two applications from M/s Shasun Pharam Ltd were sent to this Department for fixation of norms for the export of Metoprolol Tartarate 25 mg and 50 mg tablets. This department has examined the matter and following norms are recommended against these application:- S.No. lmport ltem Qty. Recommended 25『ng per tablet 50 rng per tab:et Nletoprolol Tartrate 25.5 mg 51 mg 2. Stear O Wet (MG/SLS) [Magnesium stearate] 1.49 mg 2.l mg 3. へvice1 1 02(M.C.C.Df,Ph.Eur,」 .P)IMiCrOcystalline Ce‖ulose 75.21m9 95.4 mg 4. Acdisol SD-711 (C.M.S.Nf, Ph.Eur,J.P ICrOSCarmellose Sodium] 1 1.8 mg 16.8 mg 5. Closure 53 mm CT Relevant, As per packing policy. 6. 400 CC′53 MM HDPE Plastic Bottle 2 (Raj Kumar) Under Secretary to the Government of lndia Phone:-23071162

F. No.350 1 1 I 461 12015-PI (Norms) Government of India New Delhi, the Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of procedures (vol.l) M/s Arene Life Sciences Ltd. Udyog Bhawan, November,20l5 2009-14 Case of The undersigned is directed to refer to DGFT u.o.No. ov12l50ll377lAM-l6lDES-3/4g6 dated the 8107/15 vide which application from M/s. Arene Life Sciences Ltd was sent to this Department for fixation of nofins under para: 4.7 for the export of Gabapentin Hcl. This department has examined the matter and the following norTns are furnished undei para4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S. No. Import Item 1 1, I -Cyclohexane Diacetic Acid 1.074 2. N-Butanol 0.583 3。 Di Isopropyl Ether 1.167 2. (Raj Kumar) Under Secretary to the Govemment of India Phone:23071162 (Shd M.V. Singh, FTDO),

〆 ″ F. No.3501 1/8681201 s-Pl (Norms) Government of lndia S.No. lmport item Betamethasone Norms Recommended for 'lkg of export 1 1.00ks 2 Under secretary to the c"r"r.rlTiljf'tT;itl PH:- 23071162 Dated:24 May,2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of procedures (vol.l) 2009-14 Case of M/s Stermone Chemicals pvt. Ltd. _ _-]h" undersigned is directed to refer to DGFT U.o.No. olt12rsorlllstAM- 16/DES-3/1740 dated the 213t16 vide which application frorn M/s stermone chemicals Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of clobetasol Propionate. 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:-

||らメリクЧ F. No.350 I 1 I 537 12015-PI Qllorms) Government of India Department of Pharmaceutical s Udyog Bhawan, New Delhi, the December,20l5 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2O0g-14 Case of M/s Almelo Pvt Ltd. The undersigned is directed to refer to DGFT U.o.No. oll82l5o/131/AM-16/DES-3/635 dated the 22/07/15 vide which application from M/s. Almelo Pvt Ltd was sent to this Department for fixation of norms under para:4.7 for the export of Oxo-Erythronolide A-ll,,l2-Carbamate. This department has examined the matter and the following norrns are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S.No. Import Item 1 Clarithromycin 2.344 2. 1, I -Carbonyldiimidazole 1.917 3. 1,8-Diazabicyclo [5.4.0] undec-7-ene 1.509 4. Oxone (Potassium Monopersulfate) 3.58 5. sopropyl Acetate 7.02 6. +-rjlmetnyl Ammo Pyridine 0.786 7. 2-lodo Benzoic Acid 1.60 8. Dimethyl Formamide 8.63 9. Iriphenyl Phosphine 1.148 2. (Raj Kumar) Phone:23071162 DircctOratc Genera1 0f Foreign Tradc, Department of COmmcrcc, (Shri M.V.Singh,FTDO), UdyOg Bhawan,New Delhi

そ Dated: June,2016 Office Memorandum subject: - Fixation of norms under para 4.7 of Hand Book of procedures (Vol.l) 2009-14 Case of M/s Venus Remedies Ltd. The undersigned is directed to refer to DGFT U.o.No. o1t12tsot1172tAW- 16lDEs-311292 dated the 16112t1s vide which application frorn M/s Venus Remedies Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of carboplatin injection BP 150mg/15m1 and 45omg/45m1. 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:- F No 35011/767/2015-Pl(Norms) Govemment ofindia Ministry Of Chemical&Fertilizers (Ralkumar) Under Secretary to the Government of!ndia PH:-23071162 Department of cOmmerce, (Shn M V Singh,FTDO), Udyog Bhawan,New Delhi S No lmport item Norms Recommended 1 Carboplaln BP 157 5mg/1 5mlinlec10n And 472 5mg/45mlinieClon

′び π F. No.350 I 1 1305 12015-PI (Norms) Government of India Udyog Bhawan, New Delhi, the October, 2015 Office Memorandum Subject: - Fixation of norms under paru 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of lv{/s Alembic Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182/50ll10lAM-l6lDES-3/102 dated the 16106115 vide which application from M/s. Alembic Pharma Ltd was sent to this Department for fixation of norns under para: 4.7 for the export of Benryl Penicillin 5 Mega Injection. This department has examined the matter and the following nonns are furnished undlr para4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S.No. Import Item Qty. Recommended. 1 BcllzyI Penicillin Sodiunl Sterile IP/BP 475.58 BOU per Lakh vials (Bamali Khastgir) Under Secretary to the Govemment of India "Phone:23071162 Directorate General ofForeign Trade, Department of COmmercc, (Shri M.V.Singh,FTDO), Udyog Bhawan,New Dclhi

F. No.350l l175ll20l3-PI (Norms) Government of India New Delhi, the Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2OOg-14 Case of IWs Astrix Labs Ltd. The undersigned is directed to refer to DGFT U.o.No. 0lllzl50l66YAM-l4lDES-3/g24 dated the 28ll0ll3 vide which application from Mis. Astrix 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 norns a.e fu.nished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-1 4:- (Raj Kumar) PI-Norms (Shd M.V. Singh, FTDO), Udyog Bhawan, September,20l4 Import Item Qty. Recommended kglkg. R,5 S)-5 -(4-Amino-5 -fkyiri-2-oxo-2H-pyrimidin- I yl)- [ 1,3 ]oxathiolane-2-carboxylicacid-2S-lsopropyl- R-Methyl-lR-cyclohexyl ester (FCE) i potassium hydrogen phosphate ium borohydride sopropyl alcohol thylamine hylene dichloride

JL F. No.350 1 I I 105 12015-PI Qrlorms) Government of India Ministry of Chemicals & Fertilizers Department of Pharmaceutical s Dated the October, 2015 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2OOg-14 Case of M/s Inchem Labs Pvt Ltd. The undersigned is directed to refer to DGFT u.o.No. olll2l50lto45lAM-L5:DES-3/1066 dated the l3l01ll5 vide which application from M/s. Inchem Labs Pvt 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 norns arsfurnished under para4.7 of Hand Book of Procedures (Vol.l) 2009-14:- inoacetonitrile Hcl shown in the process or reaction. Hence 4-hydroxy Phenyl)-2 -Butanone (Barnali Khastgir) Phone:23071162

/99/2015‐ PI cヽOrlns) ・ １ ， ５ ｈ ｌ ０ ５ ５ ｔ ｈ ｉ ｓ 陥 祠 ｇｉ ｒ＞ ｌ ｄ ｉ ａ ｌ ６ ２ S.No. \Rort ttem 7° mmended kg/kg・ 1 1-(4-Hydroxy Ph Hcl) 酬「 Th° nh狙J Octopamine / ＼ 0.77 /2. 4-(4-Hydroxy Ph lnyl)-2-BtanOne / 0.91 3. Methanol ＼ / 1.87 ヽ 4. Ethyl Acetate ＼/ 2.44 (Barnali Khastgi Under Secretary to the Govemment of Ind Phone:230711( Directorate G*.er6fof F$rei gn Trade. Department of Commerfe, (Shi M.V. Singh, FTDp), Udyog Bhawan, New pelhi ＼ ＼ .、 Subject: - of norms under para.7 of \and Book of Procedures (Vol.l) 2009-14 M/s M Chem Pharlna Ltd. The underdigndl dated the l3l0ll15\id Department for fixat
department has examin) Book of Procedures (Vr is directed to which appli from ).No.01/82/50/1057/AM‐ 1 RA Chem Phalllla Ltd wl 点 馳監 艤£ 棚 駆 脚 ｓ ｅ ｎ ｔ ｔ 。 耐 ﹇ of norms under 4.7 the rnatter and the l)2009-14:― ＼ ＼ ＼ ヽ ヽ ヽ ヽ

もろ弓 ICase No:9/グ Meet No/Datei21/82‐ .ORGANICs LTD 靴l淵1冊鸞獅紺熙:聯『鰤窺粛聯 Export proOuct Exp Qtv SI No. :mport tems Qty. allowed 榊 l Kg 1 iv:yrcene oo% 1 00 kg 2 Methyl Ethyl Ketone 0.600 kg 3 Toluene 0 02 kq Phosph6面 0 150 kg RA concerned FりaCtiOn as perabOve dedgon d NC

ハ lι l16 Party Name:SOHAN Party NamciSOHAN ,Mcet No/Date:20/82- lHEALTHCARE PVT.LTD IALC4/2012 sion : In the light of written comments received from Department of Pharmaceuticals their OM No. 3501116412012-PI(Norms) dated 24.7.2012, it was decided to ratify norms Para4.7 of HBP vl as per details given below or as applied by the firm, whichever is RA may take appropriate action as per the decision of Norms Committee. Quantity allowed Metformin Hydrochlo「ide BP/EP/∪SP 1/Vhite Dicyandiamide (DCDA) ICase No.:5/41/82¨ ALC4/2011 : IHQ File 101/82/050/01006/AM12/ :RLA File :Lic.No/Datei31 1 0052178 :31/83/040/00195/AM12/ 130122011 Item of Export Quantity S,No Item of lmport l kg 0 567 kg 2 ｅ ｎ ｍ Ａ Ｍ ｅｔ ｈ ｙ ｈ ‐ ｏ ｒｉ ｄ ｅ Ｃ Ｏ ｄ ｌ 　 ｙ Ｄ Ｈ 0 60 kg 3 Mix Xylene 0 027 kg 4 A/1ethanol 0 237 kg

ι ｉ ｆ ′ 衝 ^ HQ File 卜01/82/050/00721/AMl1/ Case N o. : 58/ 22 I 82- ALC4 I zOtO Party Name:KDAC CHEM PVT Decision:。committee considered case as per agenda and in!ight of written comments forwarded by Department of c&Pc vide their U.oo No.14010/97/2007/Ch.‖ dated 27.09.10 and in cOnsuitation w:th technica:authority present in meettng′ decided to ratify norms under para 4.7 of HBP as per detal:s be:ow orasapp‖ ed by firm whicheveris:ower:‐ Export product ” ⑩ S:.No. lmport items Qty. allowed Styrallyl Acetate (1-Phenyl Ethyl Acetate l Kg. Styrene Monomer 0.635 kg concerned may take further necessary action as per above decision of NC. Lic,No/Date:3410027273 17.06。2010

ノ ロ F. No.3 50 I | /3161201 4-PI (Norms) Government of India Department of Pharmaceutical s New Delhi,the Udyog Bhawan, December,20l4 SutteCt:ぅ∫ :タユ IIFl,繁ell181,sl()ltIりII:」:ξlli:II13::『it:'Procedures(V01.1) The undersigned is directed to refer to DGFT U.O.No. Ol/g2l50ll244lAM- 14IDES-3 /203 dated the 09105/14 vide which application from M/s. Vivmed Labs (Alathur) Pvt Ltd was sent to this Departmenf ror fixation of norms under para: 4'7 for the export of Valacyclovir Hydrochloride Tablets. This department has examined the matter and the following norms are furnished undei pu.u 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- 2. NC may refer the issue of 8o/o water content to DCGI for their comments vis-d-vis the Drug-Manufacturing License issued by them. 3. (Barnali Khastgir) DirectOrate Genera1 0f Foreign Trade, Departrnent of COmlnerce, (Shri M.Vo Singh,FTDO), Udyog Bhawan,Ncw Delhi Valacyclvoir Hcl BPAJSP 556mg/500mg tablet & 1112mg/1000mg tablet

‘ 衝 ⌒ case No.:91/ t t82-ALc4t20t3 @ @ lStrtr.f"; ICOMBUSTION EFFICIENCY IALC4/2013 jnpproved ICHEMTCALS PVT LTD 104.04.2013 I HaFil. m@F.f*D"t" :01/82/050/0r449tAMt3t l:03t94t040t00899/AM l3l lr t.OZ.ZO t: I Petrochemicals vide their U.O No. 1401011012009-Ch. II dated 16.4.2013, it was decided to ratifu norns under Para 4.7 of HBP v I as per details given below or as applied by the firm, whichever is less: Export Product Export Qty. SI No. lmport items Qty.allowed Kubochem‐ 401 (Diethyl ketone or 3‐ Pentanone) l kg Propionic Acid Purity 99 0% Min. 1.92 kg RA may take appropriate action as per the decision of Norms committee.

権 lζ ICase No.:59/8/82-ALC4/2014 1367 1 lPODER ~° |‐ I GRA｀6L魚 | ‐ 6 1 1 RA may take appropriate action as perthe declsion of Norms Committee i ,LIヽ41TED、 092014 :iO 1lit 良 [A lilも titiヽ。 ,b:i`0ケibibζ Oil 15もヽ「bitさ : :01/82/050/00723/AM15/ 1107/24/040/00113/AMi5/ 118072014 1 1Decision::n the light of wntten cOmments received from Department of Chemtaにand Petrochemicals宙de their u o No,14010/56/2011-Ch.‖ dated 22.05.2012′ t was decided to lraufy norms under Para 4 7 of HBP vl as per details given below or as applied by the lrm′ lwhicheveris iess: Export product Exp. Qtv SI.No. lmport items Qty AIlowed CALCIUM GLUCONATE― POヽやつER CALCIUM GLUCONATE― GRANULAR 1 025 kg ノ 「ゞフ 一 　 ” 　 Ｏ Ｖ ¨ ｔ ｕ ｐ ｒ 一 Ｓ ｔ ａ Ａ ｐ Name:GLOBAL ALCIUM PRIVATE

ノι 一怖 1 1Case No.:208/6/82‐ALC4/2014 Party Name:GLOBAL IMect No/Date:6/82‐ Status: : iCALCIUM PRIVATE :ALC4/2014 1Approved : :LIMITED, 29o82014 : : | :taSC lN O・:ZUO/0/OZ‐ALし4/ZU14 rarty NameiしLOBAL IMect No/Date:6/82‐ iStatus: : | l iCALCIUM PRIVATE :ALC4/2014 1Approved l l 1 lLIMITED, 29082014 1 : | :HQ Filc lRLA File :Lic No/Datc10710105511 1Defer Datel l l l:01/82/050/00610/AM15/ :07/24/040/00038/AM15/ 1030720:4 1 1 1 1Decislon:ln the‖ ght of w‖ tten comments received frOm Department of Chemica:s and PetrOchemicalsl l Vide their U O No 14010/56/2011-Ch‖ dated lo o7 2013,■ was decided to ratify norms under Para 4 7 : 274 0f HBP vl as per details g市 en below Or as applied by the irm′ whichever is less: | Export product Exp Qty SI No lmport items Qty allowed CALCIUM GLUCOHEPTONATE l kg 1 SODIUM GLUCOHEPTONATE 1 49 kg CALCIUM CARBONATE 0 203 kg iRA may take appropriate action as per the decision of Norms Committee.

lι 一 れ | : :し 1lVil l Eり, lzD υソZυ 14 1 i : IHQ Fli i良LA Fil :ご|き|ヽ6,biもibヴibibbi亨ぢib:fel : | ::01/82/050/00340ノAM15/ 1107/24/040/00484/AM14/ 03 04 2014 1Date:12112014: :Decision : ln the light of written comments received from Department of Chemicals and :Petrochemicals vide their U.O No. 14010/56/201,1-Ch. ll dated tg.O7.201,4, it was decided to :,.^ ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, t(Q: | :0し‖y,:υ ,:‖ ぅu ilu 168:whichever is less: |:画面画面 ::黛薫薫牽彙夏華糞翼棄嘉革撃華奪華 Export product Exp Qtv SI.No lmport items Qty AIlowed CALCIUM PIDOLATE 1 PYROGLUTAMIC ACID 1 02 kg MACNESIUM PIDOLATE 1 PYROGLUTAMIC ACID 1 02 kg take コ 一 1)}一 :摯 雨ふ晟 滋 =LCN4/2面輩 Iぶ品まこ16百A: 理 棚 曽 ぎj二 :蕊 |ム : | | :LIMITED, 25092014 1 i : IHQ Fli i良LA Fil :ご|き|ヽ6,biもibヴibibbi亨ぢib:fel :

lι 一ノ p6 為 172 : iCase No.:H4/10/82- lPatt Name:BENZO CHEM IMcet No/Date:18/82- Status:Casei ' ALC4/2013 1NDUSTRIES PRIVATE IALC4/2013 1Approved i 1 1 :LIMITED, 119122013 1 : IHQ File iRLA File lLic No/Date:0310727451 1Defer Date: 101/82/050/00297/AM14/ :03/94/040/00991/AM13/ 108032013 1 1Decision:ln the light of written comments received from Department of Chemicals and lPetrOChemicals vide their u.O No.14010/29/2011-Ch ll dated 26.12.2013′ it was decided to lratify nOrms under Para 4.7 of HBP vl as per detalls g市 en below or as applied by the irm′ vvhichever is less: Export product Exp. Qty. SI.No. lmport items Qty. allowed 2,4-DICHLORO PHENYL ACETYL CHLORIDE l kg 1. 2,4-DICHLORO BENZYL CHLORIDE 1.830 kg 2. SODIUM CYANIDE 0.518 kg 3. TOLUENE 0.513 kg 4. THIONYL CHLORIDE 0.665 kg 5. CAUSTIC SODA FLAKES 0.640 kg rRA may take appropriate action as per the decision of Norms Committee. |

μ 一 冽 ‐ ёЬζさNol●イわ0,821 1ALC4/2011 ‐ ‐ 白O FIIさ ‐ ‐ :01/82/050/00724/AM12/
‐ l bさ6sもム i co品品蔽 eきさ 6nζ tte‖ γ運惜騨猟覗 i[i粥 may take further necessary action as per above decision of NC. 瞳辮1壽獅爾ml欄n仰紬 exportlroauE Exp. Qtv. SI No lmport items Qty. allowed rvrsU ryr I I tpilenyt rnosphonlum Bromide l Kg Triphenyl Cfrospnine 0 886 kg Concerned Party Name:TATVA ,M"et No/Date:26lg2_ ,status:Case P/T LTD .27.09.2011 ^vv,vv.( l;;;;^- -**;-

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エ ア11 Case No.:33/24/82‐ ALC4/2013 :祠皿:lⅦLTDI脚αラ藤師 「IQ File 01/82/050/01232/AM14/ 渤鵬υ∞"5/AMW絆∬鼎α "Ю“"" )efer Date: Decision :!n the light of w‖ tten comments rece市ed from Department of Chemica:s and )etrochemicals vide their u.O No.14010/33/2011‐ Ch.‖ dated 15.09.2014′ it was decided tc ・atify norms under Para 4.7 of HBP vl as per details g市 en below or as app!ied by the nrm′ ″hichever is less: Export product 帥 帥 SI.No. lmport items Qty. allowed 2‐ Phcnyl‐ 3,3‐ bis(4‐ hydroxy phenyl)phthalinlidc (PPP‐BP) PTHALIC ANHYDRIDE 0.927 kg PHENOL 1.145 kg ZINC CHLORIDE 0.546 kg 4. ANILINE 0.730 kg METHANOL 2.00 kg ACTIVATED CARBON 0.400 kg 7. 菱 o kg RA may take appropriate action as per the decision of Norms Committee.

L ⌒ Case No B-119 M/s DEEPAK NOVOCHEM TECHNOLOGIES LTD′ Meeing No.12/AM15 dated-15122014 Fo No.01/82/050/00248/AM 14/DES― |‖ RLA F.No.31/83/040/00221/AM13 Adv lic No.3110058085 dated 26.042013 Decision: ln the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No 14010/39/2011-Ch.‖ dated 12 12 2014′ it was decided to revise the norms under Para 4 7 of HBP vl as per detalis given below or as applied by the firm,whicheveris less: E,xport product Export Quantiり S No Import items Quantity Allowed 2.6 Xylidine l kg l 2,6 xylenol 1 90 kg RA may take appropriate action as per the decision of Norms Committee.

|ク プ ″ ヘ F. No.3501 I 12912016-Pl -Norms Government of lndia Shastri Bhawan, New Dethi New Delhi, the December 19' 2016 Office Memorandum subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol'l) 2009-14 case of M/s lndoco Remedies Ltd' TheundersignedisdirectedtorefertoDGFTU.o.No.ol/821050/01841/AM-16/DES- 3/16 dated the o+.oi.ioro vide which "ppri..ti""from M/s rndoco Remedies Ltd' was sent to this Department foi fixation of nor6 u]ii"1 p""' +'z toi ne export of Bimatoprost 0'3 mg / ml Eye Drops, solution 3 m! Bottle. Thii department has examined the matter and the folrowing norms are ruinisned under i^i^ q.i oi Hano Book of Procedures (Vol'l) 2009-14: - (Barnali Khastgir) Under Secretary tO the Government oflndia Phone:23323292 Email:bam.khastΩ nに.in (Shri Nirmal Kumar, DY DGFT)' Email: nirmal.kuma165@nic' in Export ltem 1 00 bOttles eimatoprost 0.S mg I 『 l「 re酬ば'8嶽ti鴇 contains: Birnatoprost O.3 mg) As per Packing Eye DroP CaPs Eye DroP lnsert 2) This issues with the approval of competent authority'

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長LA「1ど Lお :ヽ675農:161161o3'65さfei b狂ぎ | :01/82/050/00342/AM15ノ 107/24/040/00340/AM14/ 19 1 : i 126032014 : : :Decision:!n the light of written comments received from Deoartment of Chemicals andi 只ヽヽ一 | :ё :;`ヽ8::】:′ζ/82‐ALC4/2bi4 Party Namc:GLOBAL IMcet No/Datc 8/82- Status: : CALCIUM PRIVATE :ALC4/2014 :Approved i LIMITED, 25092014 1 1 : :Decision:ln the‖ ght of written comments received from Department of Chemicaに andi l ,PetrOchemicals vide thei「U.O No.14010/56/2011-Ch.‖ dated 19.07.2014′ it was decided tol : lraufy nOrms under Para 4.7 of HBP vl as per detaiL given below or as applied by the irm′ | l whicheveris less: Ｓ ‐ Ｎ Export product Exp Qtv. lmport items Qty. Allowed 1 MAGNESIUM OROTATE OROTIC ACD 1 104 kg CALCIUM OROTATE OROTIC ACD 1059 POTASSIUヽ4 0ROTATE OROTIC ACID 1020 4 ZINC OROTATE OROTIC ACID 0980 5 FERROUS OROTATE OROTIC ACID 0 976 kg ― Ｉ Ｌ Ａ

tr 約′53 ζ tZ¬ | HQ File lRLA Flle 'Lic.No/Datei3 11 0057722 :01/82/050/00250/AM14/ 131/83/040/00180/AM13/ 101042013 Decision : In the light of earlier decision taken in meeting no.22lAM l3 dated 18.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: ExpOrt product 2,3,6 TriinethyI Phenol (TMP) 師 Ｑ ｔ ｙ ． ‐ ｋ ｇ SI No Import items Qty. allowed 1 Meta Cresol 0 882 kg つ ４ Methanol 0 575kg Catalyst 0 027 kg RA may take appropriate action as per the decision of Norms Committee. l iCase No.:67/10/82‐ ALC4/2013 1Party Name:DEEPAK LC4/2013 1Party INOVOCHEM ITECHNOLOGIES LTD :ALC4/2013 122082013 ||

ヘ '1b zr<Q F. No.3501 1/80/201 6-Pl (Norms) Government of lndia Ministrv of Chemical & Fertilizers Depariment of Pharmaceuticals Shastri Bhawan, New Delhi' New Delhi, the December 19' 20't6 Office Memorandum Subiect:.Fixationofnormsunderpara4.TofHandBookofProcedures(Vol.l)2009-14Case of M/s Sanjiv Paranteral Ltd' TheundersignedisdirectedtorefertoDGFTU.o.No.olls2tosolooo22lAM17/DES. 3/64 dated the 05/05/2016,jii"'*iii'i''[piesentation from M/s. sanjiv Paranteral Ltd" was sent to this Department toi'ii"ii". "t norms under oara. 4.7 for the export of Netlisan lniection-100 mg This O"p"t'""ti hls examined the matter and the following norms are ilj;ffi;-ril";'ir,^ i7 oiirino Book of Procedures (Vol'l) 200e-14: - This issues with the approval of competent authority fW"e-W (Barnali Khastgir) Under Secretary to the Government of lndia Phone 23323292 Email: barn.khast@nic in 2 Directorate General of Foleign Trade' DeDartment of Commerce' (Shri Nirmal Kumar, DY DGFT), iJdyog Bhawan, New Delhi Email: nirmal.kuma165@nic in さ:mported … be ExpOrted Nellmicin Sulphate 100 AmPoules meCtiOn_100 mg ξ謂 :‖(:j瀾!lir:n)i:ml鴫

|`昨 ｀ な 竹 RI´ A File :03/95/040/00864/AN/412/ per Lic.No/Date:0310676884 Defer Date: 16.012012 Decision : In tlre light Petrochemicals vide thei ratify norms under Para whichever is less: of rvritterr comments received fiorn Department of Chemicals and r U.O No. 140l0l95l20l l-Ch. II dated 27 .03.2012, it rvas decided to 4.7 of HBP v I as per details given below or as applied by the firm, Export Product Export Quantity S.No Import Product QLrantity allowed Dipentanrethylene Thiuram Tetra Sulfide (Qureacc DPTT) l kg | Pipericline 0.490 kg may take appropriate actiorr as per the dec sion of Norms Committee. l iCase No.:2/43/82‐ALC4/201l Party Name:YASHO IMeet No/Date:3/82¨ INDUSTRIES PVT.LTD. :ALC4/2012 117.04.2012 HQ File Status:Case : Approved ― ．

イ /~｀ 粋 て 、ナ 1ヽ、・■ … 丁 1 tNt fv'ltnr: r L,'T |,っ11,522メ201し―PI(N(,「l■lS' ;=,′ イ trilillerit Of india 「■11;γ l●ITl()傘lS&|・ertiliZers ■ll1'1l Ctf PI｀arlllacetitiCθ lS gl副1虐「冨鼻Ъ ttЪ ,現1: Q静 `ユ 養塑gむ■ば1 0f1laFnd i・iO●lk Of PFOCedtlres ttbOut reqtleSt Su税ettfttT」:t朧誌 1:=ヒ1lIЪ17 The unders19r O()9_14‐ 一∵一gふl mnterialξ お‐ 66‐ⅢI111煙理 =I11 :ilI二:I":IT,こ支 .6五 1111111‐7轟墨 llttP9ギ::砕驀警: Sf. ' Description ol trxporL " ' ^ '-t bolti-e: i 'i No : o'o1"t.,^.-,rn,r. i 5lt (;rpro{lt]xut-'n- '' : 1't IIこゎ rOll嶽ムふ |■lTl鷺1 )rofl()Xacln l i : IM( 1 4 111ゝ i lvfl 1,. 輛鸞氣馨批 l ciprof10Xacin bottie tJl点 農二s耐 陸げ 研訓d∞m耐馘 頭旧 " 癬柩■.…帥 …騨“ぼ岬唸銃lttl櫂 ヽ ＼J

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に 一 移 ハ F・F Palty Namc:BENZO CHEM INDUSTRIES PRIVATE LIMITED, ALC4/2013 1912.2013 Case No.:125/14/82- Decision:ln the light of written comments received from Department of Chemicals and Petrochemicals vide their u.O No.14010/29/2011-Ch ll dated 26.12.2013′ it was decided to ratify norms under Para 4.7 of HBP vl as per details g市 en below or as applied by the nrm′ whicheveris less: Export product Exp Qty. SI.No. lmport items Qty. allowed 2,4-DICHLORO BENZYL ALCOHOL (PROTECTOL DA) l kg 1. 2,4-DICHLORO BENZYL CHLORIDE 1.40 kg 2. CAUSTIC SODA 0.730 kg

lι Page l ofl ―329 Case No:59/21/82‐ ALC4/2011 Party Name:VIC INDUSTRIES, Meet No/Date:21/82- ALC4/2011 23082011 HQ F‖e:01/82/050/00641/AM12/ RLA File l1 7/24/040/00017/AM12/ Lic No/Date:1710004353 14072011 B::器」 f熙辮ざ;ど‖詐ts,ス諮ガ 1翻::滉:,た‖‖咄乱も :営盤肥iT:‖電潔:薔i蝋 麗iξ譜脂響1瑞i:li:「常‖淵需翼rぜ棚 ed b面″ normS under pam 47 d HBP as pα ′er:― Exp。■product Exp Qty SI No lmport items Qty a‖owed Product AP-05 (COntaining 50% of Phosphated Ester of 2 Ethyl Hexanol(50%)) l Kg 2 Ethyl Hexanol 0 365 kg ０ ４ Phosphorous Pent,cxide 0 135 kg 3 Propylene Glycol 0 100 kg perabove dedgon d NC http:〃dgft gOv il177cxinV2000/conlnlittec/inect adv4 2112.htin 10_01_2017

)● 多 Page I of 1 No.:11712/82‐ALC4/2013 STRIES PVT LTD, :01/82/050/00435/AM14/ :17/24/040/00009/AM14/ : ln the light of written comments received from Department of Chemicals vide their U O No 14010/69/2011/Ch l!dated 05 03 2014′ it was decided to under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever NC FLAKES (STEARIC DIETHANOL ANIINE CONDENSATE) (Appcarance:Creamish Flakes) STEARIC ACID (Appcarance:OffWhite OLEYL ALCOHOL 80/85 take a action as per the decision of Norms Committee. http:〃dgft gov.in/e対m/2000/comlnitee/meet adv4 2214 htm 10‐01-2017 ^ Veet No/Date:22/82- 4LC42013 20022014 Status:Case 4.pproved しic NolDate:1710005298 260420i3 Defer Date: Export Product Ｖ 噸 Ｑ ｕ ａ ｎ ｔ ｉ S No lmport Product Quantity Allowed l kg 0 762 kg 2 DIETHANOL AMINE (Colourlcss clear liquid) 0 190 kg 3 0 03 kg 4 ETHYLENE OXIDE (Colourlcss Clear Licuid) 0 07 kg

^ ⌒ 券ダ角"澤 ′S/以ら メ″ Covemment ofindia Ministry of Chemicats and Fertilizers Department of Chemicals and Petrochemicais Subject Advance Authorization application from ltrl/s. Esteem lndustries hrt. Ltd. for the import of raw materialagainst the export of Glycerin Ester (Advance Authorization No. 1710006170 dated 04.9.2015) Ref: U.O. No. 01 /8?0 51fi277 I AM-1 6/DES-ll l/1 31 0 dated 1 6. 1 2.201 5 M/s. Esteem lndustries Pvt. Ltd. has submitted present application for the import of raw material against the export of Glycerin Ester The application has been examined and the Department recommends the following norms for the present Advance Authorization application. This issue with the approval of competent authority. ;.2016

1. ltem of Export Qty. Item of lmport Qty Glycettn Ester l kg 1.Ethylene Oxide 0.6483 kg. 2.Stearic Acid 0.2790 kg lA.K.AGXRWAL) Addl.lndust面al Advlser Tel.No.011‐23381430 /

ICase No.:22/19/82-ALC4/2013 1Party Name:GITANJALI : iCHEMICALS PVT LTD : | ′ζ ge3 滞麟 rd9/82-警 ∬ : ILic.No/Date:0310753952 1DeferDate: : 117102013 1 : 「 IHQ File 101/82/050/00967/AM14/ IRLA Flle l:03/94/040/00614/AM14/ ― ― l Decision : ln the light of written comments received from Department of Chemicals andl Petrochemicals vide their UO No. 14010/41/2011-Ch !l dated 25.05.2013′ it was decided tol | lratify nOrms under Para 1200'whichever is iess: 4.7 of HBP vl as per detalls g市en below or as applied by the lrm′ : ,RA may take appropriate action as per the decision of Norms Committee. Export product Exp. Qty. SI.No. lmport items Qty. allowed 4-CHLORO ANISOLE l kg PHENOL 1.470 kg 2 SODIUM HYDROXIDE 0.430 kg 3 DIMETHYL SULFATE 0.830 kg

l6 s1 r: F.No.3501 1/21 5/201 6-Pl (Norms) Government of lndia Dated: September,2016 Office Memorandum subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 case of M/s Vindhya Pharma (lndia) Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215014941AM-17|DES-31437 dated the 1gt8l2}16 vide which application from M/s Vindhya Pharma (lndia) Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of (S,s,s)-2-Azabicyclo- (3,3,0) Octane-3carboxylic Acid Benzyl Ester Hcl. This department has examined the mitiei anO the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- This issues with the approval of competent authority (Ralkumarl Under Secretary to the Government oflndia PH:‐ 23071162 Udyog Bhawan, New Delhi. S No lmport item Norms Recommended for 1kq Export 1 @-carborylic acid benzyl ester hcl 2 127kg

| ` 多¶ト Party Name:METROPOLITAN EXIMCHEM LTD ALC4/2013 22.082013 sion : In the light of wriften comments received from Department of Chemicals and Petrochemicals theirU.ONo. 14010/6012012-Ch.lldated2l.3.2013.itwasdecidedtoratifynormsunderPara4.Tof P vl as per details given below or as applied by the firm, whichever is less: Case No.:145/10/82- ALC4/2013 DADAS (4,4-Diamino Diphenylamine Sulfate 4.4-Diamino Diphenylamine 2 Sulfonic Acid :HQ Filc lRLA File :01/82/050/00328/AM14/ :03/95/040/00076/Aヽ414/ Item of Expoft Quantity S,No Item of Import Quantity allowed l kg 1 1 260 kg つ ４ Activated Carbon 0 150 kg

鷹 ン 塑 F.No.3501 1 i214 12016-Pl (Norms) Government of lndia Dated: 2016 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case of M/s Virupaksha Organics Ltd. The undersigned is directed to refer to DGFT U.O. No. 011821050148714M- 17IDES-3/389 dated the 1710812016 vide which application from M/sVirupaksha Organics Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export ofDaclatasvir Dihydrochloride. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- (Ralkumar) Under Secretary to the Government oflndia PH:‐ 23071162 Depanment Of Commerce, (shn M∨singh,FTDO), Udyog Bhawan,New De:hi S No lmport item Norms Recommended for '1kq Export 1 4,4-Bis(2-((S)‐ Pyrrolidin-2-yl)-lH― imidazol― 5vl)-1,1-biphenyl hydrochloride 0 70 kg つ 乙 Moc― L―Va‖ne 0 55 kg 3 N‐ (3‐DimethylAminopropyl)‐ N‐ Ethyicarbodiimide Hci 0 60 kg

牝 |こ 一り)ぅ Case No.:28/21/82-ALC4l20l2 :Party Name:GLOBAL Mcct No/Date:23/82- UM PRIVATE ALC4/2012 01 11 2012 RA may take appropriate action as per the decision of Norms Committee. Lic.No/Dtte:0710090154 : In the light of earlier decision taken in meeting no.36 dated 7.12.2010, it was to ratify norms under Para 4.7 of HBP v I as per details given below or as applied by firm. whichever is less: Calcium Gluconate- lnjectable Grade USP Calcium Boro Gluconate IHQ Flle lRLA File :01/82/050/00658/AM13/ 107/24/040/00142/AM13/

1012013 File:17′ 24/04000081ノ : In the light of earlier decision taken in meeting no.5182 dated 3.5.201l, it was ratifu norms under Para 4.7 of HBP vl as per details given below or as applied by the (POlyethylene Glycol Stearyl Ether decision of Norms μ 彰 Page 1 of 1 http://dgi gov.ilL/eXinv2000/conunittee/meet“ v4 0414 htm 10‐01‐2017

ン // 一tl ll´ F No 35011ノ270/2016‐ P!(Norms) Government oflndia Ministry of Chemical&Fertilizers Department of Pharmaceuticais Datedi October,2016 0ffice Memorandum Sublect‐ Fixation of norms under para 4 7 of Hand Book of Procedures(∨o:り2009‐ 14 Case of M′ s Greりたりは “ a Ltd. The undersigned is directed to referto DGFT U O No 01/82ノ 50/452&594/AM― 17/DES‐3/497&549 dated the 24/8/2016&6/9/2016 vide which application from M/s Granules lndia Ltd was sent to this Department for lxation of norms under para:47 for the export of Ledipasvir Acetone Solvate.This department has examined the matter and the fo‖ owing norms are furnished under para 4 7 of Hand Book of Procedures(∨oll)2009‐ 14■ (Ralkumar) Under Secretary to the Government oflndia PH:-23071162 Depanment Of Commerce, (shn M∨singh,FTDO), Udyog Bhawan,New De:hi S No lmport item Norms Recommended for 1kq Export 1 (6S)‐ 6‐ [5‐ [7‐ [2‐ (lR,3S,4S)-2‐Azabicyclo[221]hept‐ 3-yl-lH―benzimidazol‐ 6-y咽-9,9-diluoro‐ 9H‐fluoren-2‐ y咽-lH― imidazol‐ 2‐ y11‐ 5‐azaspiro 12 41 heptane Hcl (1:4) 0 965kg メ2 N‐Methoxy carbony卜L‐valine 0 70kg

レ イ F. No.350'1 1/7212016-Pl (Norms) Government of lndia Dated: June,2016 Office Memo,randum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case of M/s Granules lndia Ltd. The undersigned is directed to refer to DGFT U.O,N.o. 011821501176214M- 16/DES-3/1930 dated the 30/3i16 vide which application from M/s Granules lndia Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Compresso GEM 70 (Gemfibrozil Granules 70%). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- 2 (Rajkumar) Under Secretary to the Government of lndia PHi 23071162 Directorale General of Foreign Trade, S.No. lmport item Norms Recommended for 1ko Export 1 Gemibrozil 0.707ks 2 Preoelatinised starch 0 083kg J Maize starch 0.1485kg 4 Sodium starch qlycollate 0.030ks 5 Povidone(K‐30) 0.027ks 6 Sodium laurvl sulphate 0.0015ks 7 Stearic acid 0.01Okg

lι h52 : ln the light of written comments received from Department of chemicals vide their u.O No.14010/49/20112/Ch i:dated 25.10.2013′ it was decided to ratify Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: No.:16ノ13ノ82‐ALC4/2013 Name:GULBRANDSEN No/1Date:15/82- 1.10.2013

(6 ...-- \qE F. No.3501 l/67912012-PI (Norms) Govemment of India Udyog Bhawan, New Delhi, the 12th March, 2013 Qfficg Memorandpfn Subject:- Fixation of norms under para 4.7 of Hand Book of Procedures (Vot.l) 2009-14 Case of lWs. RA Chem Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215016'76/AMl3/DES-3/875 dated the 09ll0ll2 vide which an 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 Drotaverine HCl. This department has examined the matter and the following comments are fumished under para 4.7 ofHand Book ofProcedures (Vol.l) 2009-14:- S. No. lmport Item l. Ortho Diethoxy Benzene 186 つ ４ Iso Propyl Alcohol り ，‘ υ ， Ｄ Sodium Cyanide 0.48 4 Para Formaldenyde 0.30 5 Methanol ０ つ ４ ０ ， (N.N.Ahuja) Section Officer PI-Norms (Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi

i6 146l F. No.350I II47312013-PI (Norms) Government of India Udyog Bhawan, New Delhi, the 2l't October, 2013 Office Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of IWs Granules India Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182/5011042/AMl3/DES- 31144 dated the l4l}5ll3 vide which representation from IWs. Granules India Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Compresso Cotrim 90(Sulfamethoxazole and Trimethoprim Granules DC). This department has examined the matter and the following norrns are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14- 2. (Raj Kumar) PI-Norms (Shri R.C. Meena, Dy. DGFT), Udyog Bhawan, New Delhi. S. No. Import Item Qty. Recommended kdkg. 1 Sulfamethoxazole 0.75 2. Irimethoprim 0.15 3. Pregelatinised Starch 0.043 4. Croscarmellose Sodium 0.04 5。 Povidone K‐30 0.006 6. Sodium Lauryl Sulfate 0.001 7. Stearic Acid 0.01

tL- I NT; F.No.3501 1 /270 12016-Pl (Norms) Government of lndia Dated: October, 2016 Oflice Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case of M/s Granules lndia Ltd. The undersigned is directed to refer to DGFT U.O.No. 01l82l51l452 & 594/AM- 171DES-31497 & 549 dated lhe 241812016 & 6/9/20 t6 vide which application from M/s Granules lndia Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Ledipasvir Acetone Solvate. This department has examined the mafter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- 2 (Rakumar) Under Secretary to the Government oflndia PH:‐ 23071162 Depanment Of Commerce, (shn M∨singh,FTDO), Udyog Bhawan,New Deihi S No lmport item Norms Recommended for 1 kq Export 1 (6S)-6-15‐ [7‐ [2‐ (lR,3S,4S)‐ 2-Azabicyclo 12 2 1]hept― 3-y卜lH‐ benzirnidazol-6-yl〕-9,9‐ dinuorO_9H_fluoren-2‐ y旧‐lH― imidazol‐ 2‐ yl-5‐azaspiro[24]heptane Hcl (1:4) 0 965kg 2 N-Methoxv carbonyl-L-valine 0 70kg ^

l( ---"- q66 F. No.350l ll8l5l20l3-Pl (Norms) Government of India UdYog Bhawan, New Delhi, the August,2014 Offrce Memora4dum Subject:- Fixation of norms under para 4.7 of Hand Book of hocedures (Vol.l) 2009-14 Case of lWs lntas Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182/5018391AM-14/DES-3/983 dated the 06102114 vide which application from lWs. Intas Pharma Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Spironolactone Tablets BP 25 mg, 50 mg and 100 mg. This department has examined the matter and the following norrns are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14- (Raj Kumar) PI-Norms (Shd M.V. Singh, FTDO), S. No. Import Item For Export of 1000 NOS Tablets (Qty. in kgs) 25 mgTablets 50 mg Tablets 100 mg Tablets 1 Spironolactone 0.0255 0.0510 0.102 2. Lactose 0.0750 0.150 0.300 Ｏ Ｊ Magnesium stearate 0.0015 0.003 0.006 4. Povidone 25 0.0018 0.0035 0.0070 く υ Poly Ethylene Glycol 400 0.0006 0.0012 0.0024 6. Pregelatinised Starch 0.0350 0.070 0.140 7. Purifled Talc 0.0038 0.0075 0.0150 8. ritanium E)ioxide 0.0005 0.001 0.0019 9. olloidial Anhydrous Silica 0.0005 0.0010 0.0020 10. [-{ypromellose 0.0030 0.0060 0.0120 Sply Plain Shipper Relevant, As per packing policy.

ti \77 F. No.350l l/455/2014-Pl (Norms) Govemment of India Udyog Bhawan, New Delhi, the February, 2015 Office Memorandufn Sub: Fixation ofnorms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of N{/s. Divi's Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182/50l5l4lAMl5lDES-31697 dated the 10109114 vide which an application from lWs. Divi's Labs Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of (Z)-2'(23-Dichlorophenyl)- 2-Liquid (Guanidinoimino) Acetonitrile. This department has examined the matter and the following comments are furnished under para 4.7 of Hand Book of Procedures (Vol'l) 2009- l4:- S. No. Import Item Qty. Recommended kglkg. l. Amino Guanidine Bi Carbonate 1.06 kg,&g う ι Acetonitrile 2.02" J. 2,3-Dichloro Benzoyl Cyanide 1.23 " This issues with the approval of Director (PI). (Bamali Khastgir) Under Secretary to the Govemment of India Phone- 23071 162

,A - q7q F. No.3501 I I 64612013-PI (Norms) Government of India Udyog Bhawan, New Delhi, the 24nDecember,2013 Officg Memorandum Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of N{/s Divi's Labs Ltd. The undersigned is directed to refer to DGFT U.o.No. 011821501462lAM-I4|DES-3/568 dated the 30109113 vide which application from I{/s. Divi's Labs Ltd was sent to this Department for fixation of norms under para:4.7 for the export of lopamidol. This department has examined the matter and the following norrns are furnished under para4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S. No. Import ltem I Atipa Di Chloride 1.40 2 2-Acetoxy Propionyl Chloride 0.49 3 lso Propyl Alcohol 8.13 4 Methanol 3.21 5 N,N-Dimethyl Acetamide 1.46 6 DiMethyl Formamide 0.78 7 Nitromethane 0.48 +8 Iriethylamine 0.50 χ 9 Ioluene 1.00 (Raj Kumar) P[-Norms (Shri R.C. Meena, Dy. DGFT), Udyog Bhawan, New Delhi.

′ z′ ´ は3 ⌒ ICase No.:6′ 45′82‐ALC4′ 2011 Party Name:SANMAR SPECiALITY CHEMICALS Meet No/Date:lo/82‐ :01/82/050/01183/AM12ノ Lic No/Date:0410131109 30112011 rcision : Committee considered cise as per agenda and in light of written comments forwarded by Deptt C&PC vide their U o'No' 14o1ol7l2o1o-Ch.ll dated 05.06.20i2 oecioed to ratify norms under para 4.7 HBP as per details below or as applied by firm whichever is lower._ Export product 恥 叫 SI.No lmport items . allowed 4¨ (2-AminoethJ)_2‐ methoxyphenOl l kg 1. 2. Van‖ ‖n Sodium Cyanide 1 124 kg O.416 kg t(A concerned may take may necessary action as per above declsion of trtc | 2

μ 吻9′ ´ 11.2014 : ln the light of written comments received from Department of Chemicals and their U.O No. 14010/61/20t0lch ll dated 28.!t.20t4, it was decided to ratify norms under Para 4. HBP v1 as per details given below or as applied by the firm, whichever is less: RA may take appropriate action as per the decision of Norms Committee. CITRUS TERPENE,ORANGE TERPENE,BRAZALIAN CITRUS TERPENE STANDARD CITRUS TERPENE ORANGE No/Date:11/82‐ 4 Export Product Ｖ 呻 Ｏ ｕ ａ ｎ ｔ ｉ S.No lmport Product Quantity Al!owed ′‐CARVONE l kg 2.50 kg

ψ 参 Paty Name:CADILA HEALTHCARE LTD., Mcet No/Date:4/82‐ ALC4/2014 03.07.2014 Lic.No/Date:0810131315 13.05.2014 Case No。:3/4/82‐ ALC4/2014 cision::n the‖ ght of written comments received from Department of Pharmaceutica!sv:de their OM 35011/566/2013-P:(Norms)dated 24.12.2013′ it was decided to raufy nOrms under Para 4.7 of HBP vl as deta‖ s given below or as apphed by the firm′ whichever is less: Export Product Export Quantity S.No lmport Product Quantity Allowed IRON SUCROSE INJECTION USP 20MG/ML (5 ML VIAL) (EACH ML CONTAIN 20 MG ELEMENTALIRON& EACH 5 ML VIAL CONTAIN 100 MG ELEMENTALIRON) L Number IRON SUCROSE 2.Ogm/5ml vial 2. VIALS(EMPTY GLASS BOTTLES 5 ML VIAL) Relevant as per packing policys 3. RUBBER STOPPER 13 MM RA may take appropriate action as per the decision of Norms Committee.

lι 一 れ gケ8 蟷 9滞」 :1量:ll∬♀ ::骨:i儲γ :|よ摘lil;i″l絆濡 l‖:ぽTI屋よ甜～ nσmSundσ h●47 Export Product ExpOrt Quantitv S No lmport Product Quantty AIlowed GAMMA BUTYROLACTONE 1,4 BUTANEDIOL 1 16 kg GBL CATALYST 0 001 kg / | :case NO.:11/4/82-ALC4/2014 Party Namc:BALAJI AMINES IMcct No/Date:4/82‐ iStatus:Casel ,LIMITED IALC4ノ2014 'Approved l ,LIMITED IALC4ノ2014 ,Approved l l :03072014 i : : ,HQ Filc 1 101/82/050/00259/AM15/ ヽ 』 Ａ 一

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5.- F. N0.3501 1/757 1201 s-Pl (Norms) Government of lndia DePartment of Pharmaceuticals Udyog Bhawan, New Delhi' Dated: 2, MaY 2016 Office Memorandum subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (vol.l) 2009- '14 Case of M/s Sriam Labs Pvt.Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82150/1 186/AM- 16/DES-3/.1299 Oated tne rctlPtl}vide which application from M/s sriam Labs Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export ofDiethyl (3,5-dimethoxy benzyl) phosphonate (ADDP-2).This department has examined t'he matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- (Rajkumar) Under Secretary to the Government of lndia PA- 23071162 S.No. lmport ltem Norms Recommended for 1 kg Export ‐ 一 3,5-dihydroxy benzoic acid 0.667k9 +#um carbonate H€4k+- 3 Sodium borohydride 0.423ks 4 TriethVl phosphite 0.932ks

(To be published in the Gazette of lndia Extraordinary) (Part l-Section 1) Government of lndia Ministry of Commerce and lndustry Department of Commerce Directorate General of Foreign Trade Public Notice No.64 12015-2020 New Delhi: Dated 17th March, 2016 Sub:- Standard lnput Output Norms under Chemical & Allied Product Group - reg. ln exercise of the powers conferred under Paragraph 2.04 of the Foreign Trade Policy, 2015-2020 and Paragraph 1.0'1 of Handbook of Procedures (Vol. l), the Directorate Generalof Foreign Trade hereby notifies Standard lnput Output Norms bearing numbers A-3645, A- 3646,4-3647.A-3648,A-3649,4-3650,A-3651 ,A-3652,A-3653,A-3654,4-3655,A-3656,A-3657,A- 3658,A-3659,A-3660,A-3661 ,A-3662,A-3663,A-3664,A-3665,A-3666,A-3667,A-3668,A-3669,A- 3670,A-3671,A-3672,A-3673,A-3674,4-3675,4-3676 and A-367T for export products the details of which are as given below. Ｏ Ｎ “ Ｓ Ｓ Description of Export ltem Export Ouantitv lmport ltems Quantity allowed (4) (6) A-3645 Alendronate Sodium Tablets 70 mg (Each Tablet contains Alendronate Sodium equivalent to 70 mg Alendronic acid) 1000 Tablets Alendronate Sodium Trihydrate 93.152 gm A-3646 Amikacin Sulphate lnjection 500 mg/2ml (Each 2 ml vial contains Amikacin Sulphate equivalent to Amikacin 500 mq) 1000 vials Amikacin Su!phate 715.81 gm A‐3647 Amoxicillin and Potassium Clavunate 1000 mg Tablets (Each tablet contains Amoxicillin Trihydrate equivalent to Amoxicillin 875 mg and Potassium Clavulanate equivalent to Clavulanic acid 125 mg) 1000 Tablets 1) Amoxicillin Trihydrate 1024238 9m 2) Diluted Clavulanate Potassium(1:1) 303.773 9m A‐3648 Amoxicillin & Clavulanic Acid suspension 228.5 mgll ml in 100 ml bottles. (Each 5 ml contains Amoxicillin Trihvdrate 1000 bottles 'l Amoxicillin Trihydrate 42009m equivalent to Amoxicillin 200 mg and Potassium Clavulanate equivalent to Clavulanic acid 28.5 mg) 2 D‖ uted Ciavulanate Potassium(1:1) 1414193 9m A‐3649 Ampicillin and Sulbactam 750 mg for injection (each vial contains Ampicillin Sodium equivalent to Ampicillin 500 mg and Sulbactam Sodium equivalent to Salbactam 250 mq) 1000 vials 1) Ampicillin Sodlum 583.77 gm 2) SulbaCtam Sodium 302.22 gm A‐3650 Ampicillin injection 500 mg (each vial contains Ampicillin Sodium equivalent to Amoicillin 500 mo) ‐ ０ ０ ｖｉ ａ ‐ Amp cillin Sodium 583.77 gm A‐3651 Atorvastatin Tablets 10 mg(each tablet contains Atorvastatin Calcium Trihydrate equlvalent to 10 mg Atorvastatin) 1000 Tablets Atorvastatin CalcliumTrihydrate 110599m A‐3652 Benzylpenicillin lnjection 5 Lac units (300 mS) {each vial contains Benzylpencillin Sodium equivalent to Benzylpencillin 300 ma) 1000 vials Benzylpenicillin Sodium 35.171 gm

A‐3653 Cefadroxil (250 mS) and Potassium Clavulanate (62.5 mg) Dispersible Tablets 1000 Tab!ets

1. CefadrOxll
   

monohydrate 267622 gm ヽじ0し‖10V]●t VV‖ tCl‖ :OV▽:quiv^:::::V:'V:'yvtu、ν equivalent to 250 mg Cefadroxil on Anhydrous basis and C!avulanate potassium equivalentto Clavulanic acid 62 5 mg) 2l Potassium Clavulanate 75 943 gm A‐3654 Cefixime for oral suspension 30 ml bottle (each 5 ml contains Cefixime Trihydrate equivalent to Cefixime 50 mg on anhydrous basis) 1000 bottles CefiximeTrihydrate 352508 9m A‐3655 Cefixime Triblets 200 mg (each tablet contains Cefixime Tridhydrate equivalent to Cefixime 200 mg on anhydrous basis) 1000 Tab Cefixime Trihydrate 228294 9m A-3656 Cefpodoxime Proxetil Tablets 200 mg (each tablet contains Cefpodoxime Proxetil equivalent to Cefpodoxime 200 mg) 1000 tablets Cefpodoxime Proxetil 266109m A‐3657 Ceftriaxone and Sulbactam for injection. 1.5 gm (each vial containing Ceftriaxone Sodium equivalent to Ceftriaxone 1 gm and Salbactam Sodium equivalent to Salbactam 0.50 qm) 1000 viais 1) Ceftrixone Sodium sterile As per S10N A‐ 407 2\ Sulbactam Sodium sterile 604.44 gm A‐3658 Cefuroxime Axetil Tablets 500 mg (each tablet contains Cefuroxime Axetil equivalent to Cefuroxime 500 mq) 1000 Tab Cefuroxime Axetil 614878 gm A‐3659 Cefuroxime for injection 750 mg (Each vial contains Cefuroxime Sodium equivalent to Cefuroxime 750 mq) 1000 vials Cefuroxime Sodium 867749m A‐3660 Cefuroxime for oral suspension 125 mg/ 5 ml in 60 ml bottles {each 5 ml containing Cefuroxime Axetil equivalent to Cefuroxime 125 ms) 1000 bottles Cefuroxime Axetil 18999m A-3661 Citicoline lnjection 250 mg /ml (each vial contains Citicoline Sodium equivalent to Citicoline 250 mq) 1000 via!s CIicoline Sodium 287399m A‐3662 Citicoline Capsules 500 mg (each capsule contains citicoline sodium equivalent to Citicoline 500 mq) 1000 capsu!es Cticoline sodium 532950 gm A‐3663 Clopidogrel Tablets 75 mg (each tablet contains Clopidogrel Bisulphate equivalent to Clooidoorel 75 mq) 1000 Tablets Clopidogrel Bisulphate 998149m A‐3664 Phenoxy Methyl Penicillin Potassium for oral suspension 250 mgl 5 ml in 100 ml bottles (each 5 ml contains Phenoxy Methyl Penicillin Potassium equivalent to phenoxy methyl Penicillin 250 mg) 1000 bottles Phenoxy Methyl Penicillin Potassium 5820 gm A‐3665 Erythromycin Stearate for oral suspension 250 mg/5m!in 100 mi botues(each 5 mi contains Etrythromycin Stearate equivalent to Erythromycin 250 mg) bottles Erythromycin Stearate 7284 gm A-3666 Levofloxacin Tablets 500 mg (each tablet contains Levofloxacin Hemihydrate equivalent to Levofloxacin 500 mg on anhvdrous basis ) ‐ ０ 。 Ｏ Ｔ ａ ｂ Levolfoxacin Hemihydrate 522750 gm A-3667 Meropenem for injection 1 gm ( each vial contains MeropenemTrihydrate equivalent to Merooenem Anhvdrous 1 qm) 1000 vials MeropenemTrihydra te 1255 gm A-3668 Methyl Prednisolone Sodium Succinate for injection 500 mg {each vial containing Methyl Prednisolone Sodium Succinate equivalent to Methvl Prednisolone 500 mg) 1000 vials ヽlethyl Prednisolone Sodium Succinate 729 30 gm A‐3669 Metronidazole oral suspension 200 mg/5 ml, in 100 ml bottles(each 5 ml suspension contains Metronidazole Benzoate equivalent to 200 mq Metronidazole) 1000 bott!es Metronidazole Benzoate 67539m A-3670 Peloxacin Tabiet 400 mg (each tablet 1000 Pefloxacin Mesvlate 569731

contains Pefloxacin Mesylate equivalent to Pefloxacin 400 mq) Tab gm A-3671 Phenoxymethyl Penicillin Potassium tablets 500 mg. {each tablet contains Phenoxymethyl Penicillin Potassium equivalent to Phenoxymethyl Penicillin 500 mo) 1000 Tab Phenoxy Methyl Penicillin Potassium 565453 9m A-3672 Piperacillin and Tazobactam for injection 2.25 gm (each vial contains Piperacillin 1000 vials 1)Piperaci‖ in Sodium 2292.4 gm sodrum equrvalent to Prperacrllrn z gms + Tazobactam Sodium equivalent to Tazobactam 0.25 qm) 2) Tazobactam Sodium 295.0 gm A‐3673 Primaquine Phosphate Tablets 2.5 mg (each tablet contains Primaquine Phophate equivalent to Primaquine 2.5 mq) 1000 Tab!ets Primaquine Phosphate 4.477 gm A‐3674 Rosuvastatin 10 mg Tablets (each tablet contains Rosuvastatin Calcium equivalent to Rosrrvastatin 1O mo) 1000 Tablets Rosuvastatin Calcium 10.625 gm A‐3675 Spectinomycin injection 2 gm/vial (each vial contains Spectinomycin Hydrochloride equivalent to Spectinomycin 2 qm) 1000 vials Spectinomycin Hydrochloride 327800 9m A‐3676 Vancomycin lnjection 500 mg (each vial contains Vancomycin Hydrochloride equivalent to Vancomycin 500 mg, vial size less than 10ml) 1000 via:s Vancomycin Hydrochloride 566 50 gm A‐3677 Amoxicillin & Potassium Clavulanate for injection 1.2 g (each vial contains Amoxicillin Sodium equivalent to Amoxicillin 1000 mg and Potassium Clavulanate equivalent to Clavulanic Acid 200 mq) 1000 vials Sterile mixture of Amoxicillin Trihydrate & Potassium Clavulanate (5:1) 1320 gm 2. Effect of Public Notice:- SIONs of the above export products falling under the Chemicals and Allied Products Group are being notified. These are new entries. (Anup Wadhavan) Director General of Foreign ttrade E―mal!:dgi@niC.in (ISSued frOm File No.01/82/162/00198/AM… 16/DES III)