IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2017-10-12

DGFT Committee Minutes

Document text

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. 05/82/2017 of 2017-18 dated 25.10.2017 considered the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products falling under Chapter 29 and 30, held on 25.10.2017 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 Arun Kumar, Consultant, Department of Pharmaceuticals. 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. MEETING NUMBER : 5/82-ALC4/2017 MEETING DATE : 25.10.2017

Case No.:4/6/85-

ALC3/20U Party NameiMATRIX LABORATORIES LTD Meet No/Date:5/82- ALC4/2017 25.10.2017 Status: Approved 1 HQ File :01/85/050/00026/AM12/ RLA File :09/24/040/00507/AMll/ Lic.No/Date:0910045940 16.03.2011 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o, Pharmaceuticals forwarded vide O.M. No.3501 l/252/2014-IPI(Norms) dated Oct. 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 ofNC. 0

Case No.:15/2/82-

ALC4/20I6 Party Name:PERFECT INDUSTRIES PRIVATE LIMITED. Meet No/Date: 5/82- ALC4/2017 25.10.2017 Status:Deferred HQ File :01/82/050/00015/AM17/ RLA File :03/95/040/00554/AM12/ Lic.No/Date:0310659678' 14.10.2011 Defer Date: 10.01.2018 Decision tDeferred. 3

Case No.:2/2/85-

ALC3/2012 Party Name:SAIRAM ORGANICS PVT LTD Meet No/Date:5/82- ALC4/20I7 25.10.2017 StatusiDeferred HQ File RLA File Lic.No/Date:0910050555 Defer

il:01/85/050/00002/AM13/ :(39/24/040/00452/AM12/ ,30.12.2011 E)ate:i3.12.2017 llDecision :Deferred.

CaseNo.:29/20/82- ;F ' ALC4/2016 r I arty Nanie;AMBUJA ' ^ NTERMEDIATES / JMITED _ ,2 /leet No/Date:5/82- i S ^LC4/2017 5.10.2017 ►tatus:Deferred "*1 HQ File I , ;01/82/050/01206/AM17/ ' : ILA File 11.ic.No/Date:0310688107|l)efer Date: 03/94/040/0n25/AM12/ ,7.03.2012 ; 10.01.2018 iDedsion : Deferred.

• ^ _ . . — — ;CaseNo.:131/16/82- 1 ALC4/2016 1' ^arty NameiSARNA CHEMICALS PVT.LTD. . i Vleet No/Date:5/82- i! \LC4/2017 25.10.2017 $tatus:Deferredi -"'HQFile ' :01/82/050/00948/AM17/ ILA File i 52/24/040/00043/AM13/ Lic.No/Date:5210039465. 14.02.2013 !)efer Date: 10.01.2018 ! Decision ; Deferred. ^ ... — iCaseNo.:173/5/82- i ALC4/2015 Party Name:FORACE ! POLYMERS (P) LTD. | MeetNo/Date:5/82- | ALC4/2017 ; 25.10.2017 j Status:Deferred: HQ File i . :01/82/050/00313/AM16/ i RLA File Lic.No/Date:05I0356983l Defer Date: ;05/23/040/00069/AM14/ ; 13.06.2013 1 10.01.2018 1 1 Decision : Deferred. 1; . i Case No.:48/13/82- ' ALC4/2015 j Party Name:BELCHEM INDS. INDIA PVT. LTD. MeetNo/Date:5/82- i ALC4/2017 25.10.2017 Status:Deferred ■ ^;HQ File ! :01/82/050/01011/AM16/ RLA File :03/94/040/00860/AM14/ Lic.No/Date:0310766718 17.01.2014 Defer Date: 10.01.2018 Decision: Deferred. . . . i: :

•• : jCaseNo.:57/3/82- 1 'aLC4/2014 ; 1 Party Name: JUBILANT LIFE SCIENCES , LIMITED Meet No/Date:5/82- ALC4/2017 ■ 25.10.2017 Status:Deferred HQ File ' :01/82/050/00061/AM15/ RLA File :05/23/040/00506/AM14/ lLic.No/Date;05103 82053 ■18.03.2014 ' Defer Date: ' 10.01.2018 ' 1 Decision ; Deferred. . • : i CaseNo.:49/13/82- ALC4/2015 1 , Party Name:BELCHEM ' INDS. INDIA PVT. LTD. Meet No/Date:5/82- ALC4/2017 ! 25.10.2017 j Status:Deferred i^i HQ File ' :01/82/050/0l0l2/AM16/ RLA File :03/94/040/01118/AM14/ (Lic.No/Date:03107792H ; 23.04.2014 )i Defer Date: , 10.01.2018 1 Decision : Deferred. . .

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Case No.:7/8/82-

ALC4/2016 Party Name:MACSON PRODUCTS Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred HQ File :01/82/050/00345/AM17/ RLA File :52/2I/040/00011/AM15/ Lic.No/Date;5210041026; 12.05.2014 Defer Date: 10.01.2018 ; 1 , Decision: Deferred. 11 CaseNo.:38/8/82- ALC4/2014 —

w - J Party Nanie:MYLAN LABORATORIES LIMITED Meet No/Date: 5/82- ! ALC4/2017 ' 25.10.2017 Status:Deferred! HQ File :01/82/050/00702/AM15/ I RLA File :09/24/040/00108/AM15/ Lic.No/Date:0910060258' 28.05.2014 ' 1 Defer Date:I3.12.2017 i I 1 - J Decision : Deferred. j 12; t

Case No.:165/6/82-

ALC4/2014 Party NameiHALDIA PETROCHEMICALS LTD. Meet No/Date:5/82- ALC4/2017 25.10.2017 StatusiDeferred HQFile :01/82/050/00567/AM15/ ^ RLA File :02/24/040/00037/AM15/ Lic.No/Date:0210203844' 05.06.2014 1 . . .1 Defer Date: 10.01.2018 ; ^ 1 Decision: Deferred. J 1 'l3; I

Case No.:264/13/82-

ALC4/2014 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date: 5/82- ALC4/20I7 ! 25.10.2017 Status:Deferred HQ File :01/82/050/01267/AM15/ i RLA File :03/94/040/00405/AM15/ Lic.No/Date:03107883971 26.08.2014 1 Defer Date: 10.01.2018 Decision: Deferred. 1 14, 1 1 CaseNo.:255/13/82- ALC4/2014 Party Name:THE DHARAMSIMORARJI CHEMICAL CO LTD Meet No/Date: 5/82- ALC4/20I7 25.10.2017 Status:Deferred HQ File :01/82/050/01258/AM15/ RLA File :03/95/040/00431/AM15/ Lic.No/Date:0310788373: 26.08.2014 Defer Date: 10.01.2018 1 ] Decision: Deferred. 1 1 ( t 15

Case No.:263/13/82-

ALC4/2014 Party Name;ANTHEA AROMATICS PVT.LTD., Meet No/Date: 5/82- i ALC4/20I7 25.10.2017 Status:Deferred HQ File :01/82/050/01266/AM15/ ' RLA File :03/94/040/00962/AM14/ Lic.No/Date;0310788558! 01.09.2014 Defer Date: 10.01.2018 ; i Decision: Deferred. 16

Case No.:217/13/82-

Party Name:ENCUBE Meet No/Date:5/82- Status:Deferred ALC4/2014 ETHICALS PVT LTD ALC4/2017 25.10.2017 HQ File RLA File Lic.No/Date:0310788620 Defer 3

:01/82/050/01220/AM15/ |:03/94/040/00494/AMlS/ 02.09^.2014 Date:13.12.2017 Decision : It was noted that fraudulent CA certificates have been submitted in this case. The matter is under investigation. Clarification has been called for No.02/82 dated 29.04.2015 is awaited. The Committee accordingly decided to defer the case. J CaseNo.:17/13/82- -1 \LC4/2014 'arty Name:GRASIM ' [NDUSTRIES LTD., 1 \4eet No/Date:5/82- ' \LC4/2017 25.10.2017 1 Status:Deferred IVl HQ File :01/82/050/01020/AM15/ ' ^A File :34/24/040/00155/AM15/ ' Lic.No/Date:3410040570| 23.09.2014 ; Defer Date: 10.01.2018 iDecision : Deferred.

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, 1 ' I ] CaseNo.:134/13/82- ALC4/2014 Party Name;MAHAVIR I SYNTHESIS PRIVATE ' LIMITED 1 MeetNo/Date:5/82- ! ALC4/2017 25.10.2017 Status:Deferred 181 1 HQ File :01/82/050/01137/AM15/ RLA File ' :52/24/040/00031/AM15/ | Lic.No/Date:52l0041251| 07.10.2014 ; Defer Date: 10.01.2018 necision: Deferred. .. :—1 .

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Case No.:42/15/82-

ALC4/2014 Party NameiPVS AGRO VET Meet No/Date:5/82- ALC4/2017 25.10.2017 StatusiDeferredi 19 HQ File :01/82/050/01329/AM15/ RLA File :09/24/040/00246/AMl_5/ Lic.No/Date;0910061105 16.10.2014 Defer Date:13.12.2017^ Decision : Deferred. 1

Case No.:110/13/82-

ALC4/2014 , 'arty Name:TATVA CHINTAN PHARMA CHEM PVT LTD I VIeet No/Date:5/82- ALC4/2017 25.10.2017 StatusiDeferred 20' i HQ File 1 :01/82/050/01113/AM15/ ' SLA File :34/24/040/00188/AM15/ _ic.No/Date:34100406351 22.10.2014 Defer Date: 10.01.2018 ] Decision: Deferred. . .

' CaseNo.:86/10/82- ALC4/2014 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:5/82- ALC4/2017 25.10.2017 StatustDeferred 21 HQ File :01/82/050/01000/AM15/ RLA File :34/24/040/00194/AM15/ i Lic.No/Date:3410040644! 30.10.2014 Defer Date: 10.01.2018 Decision: Deferred.

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Case No.:266/13/82-

ALC4/2014 Party Name:ATUL LIMITED, Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred '22 HQ File 1:01/82/050/01269/AM15/ RLA File :08/24/040/00289/AM 15/ Lic.No/Date:0810133735 05.11.2014 Defer Date: 10.01.2018 Decision : Deferred. , —

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Case No.:268/13/82-

ALC4/2014 Party Name:ATUL LIMITED, Meet No/Date:5/82- ALC4/2017 25.10.2017 $tatus:Deferred| HQ File :01/82/050/01271/AM15/ RLA File :08/24/040/00283/AM15/ Lic.No/Date:0810133734 05.11.2014 Defer Date: ! 10.01.2018 j Decision: Deferred. 1 ... ; ; \24 i CaseNo.:107/13/82- ALC4/2014 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date: 5/82- 1 ALC4/2017 ' 25.10.2017 Status:Deferred HQ File ;01/82/050/01110/AMl 5/ RLA File :34/24/040/00I96/AM15/ Lic.No/Date:3410040655! 05.11.2014 :

. Defer Date: ; 10.01.2018 Decision : Deferred. ' ' 1 1 1 ' :25j CaseNo.:lll/13/82- i ALC4/2014 Party Name: ABEERS PHARMACEUTICALS ' PVTLTD Meet No/Date:5/82- ALC4/2017 [ 25.10.2017 ! Status:Deferredi i HQ File :01/82/050/01114/AM15/i RLA File i :05/23/040/00352/AM15/ ' Lic.No^ate:0510391927! 11.11.2014 J Defer j Date:I3.12.20171 Decision: Deferred. | _ 1 i i 1 '26 1 [ i ' i j CaseNo.:100/4/82- : ALC4/2015 1 I Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:5/82- ^ ALC4/2017 ! 25.10.2017 i $tatus:Deferred' HQ File :01/82/050/00139/AM16/ ' RLA File :17/24/040/00125/AM15/ I Lic.No/Date:1710005978l 12.11.2014 ! Defer Date: ! 10.01.2018 ; Decision: Deferred. .... 1 27! CaseNo.:120/13/82- | ALC4/2014 _ ... 1 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date: 5/82- 1 ALC4/2017 i 25.10.2017 ; Status:Deferred| HQ File i ;01/82/050/01123/AM15/ i RLA File :05/23/040/00325/AM15/ ; Lic.No/Date:0510391947i 12.11.2014 1 Defer Date: 10.01.2018 jDecision: Deferred. r . i 28| 1 1 f CaseNo.:65/15/82- ALC4/2014 Party NameiABEERS PHARMACEUTICALS PVT LTD Meet No/Date;5/82- 1 ALC4/2017 25.10.2017 Status:Deferred. HQ File :01/82/050/01352/AM15/ 1 RLA File :05/23/040/00360/AM15/ ' Lic.No/Date:051039201ll 14.11.2014 i Defer Date:13.12.2017' 1 _

1 291 1

Case No.:32/2/82-

ALC4/2016 Party NameiSTERLING AUXILIARIES PVT LTD Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred,

HQ File ; :01/82/050/00032/AM17/ ' RLA File | ;03/95/040/00617/AM15/ | Lic.NoA3ate:0310791470| 27.11.2014 ! Defer Date; 10.01.2018 Decision : Deferred.

' iCaseNo.:102/20/82- IP iALC4/2016 P 1 i arty Name:KLJ 1N LASTICIZERS LTD., \P feet No/Date:5/82- | S lLC4/2017 5.10.2017 _ tatus:Deferred. ® HQ File ' :01/82/050/01279/AM17/ !: XA File 1 ^ 35/23/040/00368/AMl_5/ j 2 ic.No/Date;05I0392210| 1 8.11.2014 ' 1 )efer Date: 0.01.2018 i Decision : Deferred. ' CaseNo.:82/18/82- ll ALC4/2014 1 'I 'arty NameiABEERS 1 1 PHARMACEUTICALS PVTLTD ^eetNo/Date:5/82- 11 \LC4/2017 i5.10.20I7 1 )tatus:Deferred' HQ File i :01/82/050/01448/AM15/ U^A File 05/23/040/00413/AM15/ Lic.No/Date:05I0392368|] 10.12.2014 j] Defer ^ Date:I3.12.20171 ii ^ 1 1 nptcision : Deferred. _ ^ :— '

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— 1 Case No.: 101/4/82- 1ALC4/2015 1 1 Party NameiESTEEM | INDUSTRIES PVT. 1 LTD, . . j Meet No/Date:5/82- ALC4/2017 ' 25.10.2017 1 Status:Deferred HQ File 1:01/82/050/00140/AM16/ : RLA File : 17/24/040/00144/^ 15/ ^ Lic.No/Date:I7I0005998 10.12.2014 _ _ , Defer Date: i 10.0I.2018_ llDccision : Deferred.

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'CaseNo.:97/18/82- ALC4/2014 1 Party NameiDYNAMIC ' SPECIALITY CHEMICALS LIMITED ^ Meet No/Date:5/82- ALC4/2017 25.10.2017_ StatusiDeferredi ^^iHQ File i:01/82/050/01463/AM15/ RLA File :30/24/040/00041/AMI5/ Lic.No/Date:3010103261 11.12.2014 Defer Date: ' 10.01.2018 _ 'iDecisinn : Deferred.

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Case No.:2/18/82-

' ALC4/2014 1 ' Party Name:SWATI 1 MENTHOL & ALLIED 'CHEMICALS LTD., Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred 1 1 File i ,:01/82/050/01368/AM15/ RLA File ' :29/24/040/00009/AM15/ lLic.No/Date:29I0025I85 1 17.12.2014 ; Defer Date: j 10.01.2018 ! '{Decision : Deferred. . _ .

—J ' :CaseNo.:88/18/82- j ; ALC4/2014 'party ' Name:METROPOLITAN : EXIMCHEM LTD. ' MeetNo/Date:5/82- jALC4/2017 125.10.2017 StatusrDeferred 1 r 1 : 1 ^;HQ File ' 1 :01/82/050/01454/AM15/ ' RLA File 1:03/95/040/00776/AM15/ jLic.No/Date:031079213: ' 18.12.2014 J| Defer Date: . 10.01.2018 ' Decision : Deferred.

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CaseNo.:105/18/82- ALC4/2014 Parly Name;KLJ PLASTICIZERS LTD., Meet No/Date:5/82- ^ ALC4/2017 25.10.2017 I Status:Deferred| HQ File i :01/82/050/01471/AM15/ | RLA File :05/23/040/00436/AM15/ Uc.No/Date:0510392586^ 26.12.2014 i Defer Date: 10.01.2018 : Decision: Deferred. 1

Case No.:38/4/83-

ALCl/2015 Party NameiS M S PHARMACEUTICALS LTD Meet No/Date:5/82- ALC4/2017 25.10.2017 Status: 1 Deferred ' 1 37| i HQ File :01/83/050/00I97/AM16/ I RLA File | :09/24/040/00566/AM15/ ; Lic.No/Date:0910061534: 16.01.2015 Defer ' Date: ' 10.01.2018! 1 ] _ ^ _ .. 38i CaseNo.:9/18/82- ! ALC4/2014 Party Name:SAIBABA SURFACTANTS (?) LTD., Meet No/Date:5/82- 1 ALC4/2017 1 25.10.2017 ; Status.'Deferred i HQ File ! :01/82/050/01375/AM15/ ; RLA File :08/24/040/00371/AM15/ Lic.No/Date:0810134344 19.01.2015 Defer Date: 10.01.2018 Decision: Deferred. 39 CaseNo.:112/5/82- ALC4/2015 Party Name:UNIMAX CHEMICALS PVT LTD. Meet No/Date: 5/82- ' ALC4/2017 ! 25.10.2017 Status:Deferred' HQ File ; :0 l/82/050/q0252/AMl 6/ RLA File :03/95/040/00812/AM15/ | Lic.No/Date:0310793039! 19.01.2015 j Defer Date:13.12.2017' Decision : The Committee observed that CA certificate furnished by the firm in two applications! reflects contradictoiy production and consumption data for the year 2013-14. Further ITCHS code' of import and export product also needs to be corrected. An investigation in the matter is under: process. The Committee accordingly decided to defer the case. 40

Case No.:204/5/82-

ALC4/2015 Party Name: VIVIMED LABS LIMITED Meet No/Date:5/82- i ALC4/2017 25.10.2017 ' Status:Deferred, HQ File :01/82/050/00344/AM16/ RLA File :09/24/040/00596/AM15/ Lic.No/Date:0910061555i 23.01.2015 ; Defer Date: ; 10.01.2018 Decision : Deferred. 41 CaseNo.:20/4/82- ALC4/2015 Party Name:D. R. COATS INK & RESINS PVT. LTD. Meet No/Date: 5/82- j ALC4/2017 25.10.2017 1 Status:Deferredi 1 HQ File :01/82/050/00059/AM16/ RLA File ;03/94/040/00759/AM15/ Lic.No/Date:0310793542j 03.02.2015 ! Defer Date: 10.01.2018 Decision: Deferred.

42

Case No.:91/7/82-

ALC4/2015 Party Name:SHREE GANESH REMEDIES I PVT.LTD. Meet No/Date:5/82- | ALC4/2017 25.10.2017 Status:Deferred HQ File :01 /82/05 0/00696/AM16/ RLA File :34/24/040/00295/AM15/ Lic.No/Date:3410040965! 16.02.2015 i Defer Date:13.12.2017 iDecision: Deferred. ;< 'j [!;ase No.:72/4/82- ^ \LC4/2015 ' 1 1 'arty Name:LANTECH 'I 'HARMACEUTICALS ^ .TD 1- vleet No/Date:5/82- , S \LC4/2017 i5.10.2017 3tatus:Deferred 431 File 01/82/050/00111/AM16/ • RLA File 09/24/040/00647/AM15/ Lic.No/Date;0910061664^ 04.03.2015 _ ] Defer Date;13.12.2017 Decision :The"committee noted that information has been ealled tor trom the ^ Ho.Olin dated 13.09.2017 is awaited. The Committee accordingly decided await the reply and deferred the case. ;44

Case No.:85/4/82-

ALC4/2015 Party NameiVIVIMED i LABS LIMITED i 1 Meet No/Date:5/82- ' ALC4/2017 25.10.2017 _ 1 1 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: 10.01.2018 ; Decision : Deferred. . ^ ,45

Case No.:106/7/82-

ALC4/2015 I Party Name:ALCHEMIE LABORATORIES Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred; iHQ File :01/82/050/00711/AM16/ RLA File . :03/94/040/00812/AM15/ ,Lic.No/Date:0310794612 ,16.03.2015 Defer ;Date;13.12.2017 Decision : Deferred. ^ 46

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Case No.:48/4/82-

ALC4/2015 Party Name;MAMTA POLYCOATS
Vleet No/Date:5/82- i ALC4/2017 25.10.2017 Status:Deferred' HQ File :01/82/050/00087/AM16/ RLA File :34/24/040/00329/AM15/ , Lic.No/Date:3410041054; 17.03.2015 Defer Date: 10.01.2018 InpHsinn : Deferred. ^ —

Case No.:65/4/82-

ALC4/2015 Party Name;MYLAN LABORATORIES LIMITED Meet No/Date;5/82- ALC4/2017 25.10.2017 Status:Deferred , HQ File , ;01/82/050/00104/AMl6/_ RLA File :09/24/040/00662/AM15/ Lic.No/Date:0910061843 31.03.2015 Defer Date:13.12.2017 47 |D(>ciRinn : Deferred. . i J I

• 1 481 Case No.:36/4/82- ALC4/2015 Party Name:NUTRA SPECIALITIES PVT. LTD., Meet No/Date:5/82- ALC4/2017 Status: Approved;

1 25.10.2017 1 HQ File :01/82/050/00075/AM16/ RLA File :04/24/040/00298/AM15/ Lic.No/Date:0410160376 31.03.2015 Defer Date: 1 1 Decision : The Committee decided to ratify norms based on the recommendation of D/o' Pharmaceuticals O.M.No. 35011/21/2017-PI(Norms) dated 25.09.2017, uploaded at the end of, these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.l.RA| concerned may take necessary action as per decision of NC. J 1

Case No.:64/4/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:5/82- 1 ALC4/2017 ' 25.10.2017 Status:Deferred HQ File :01/82/050/00103/AM16/ RLA File :09/24/040/00595/AM15/ Lic.No/Date;0910061851, 31.03.2015 Defer Date: 10.01.2018 Decision: Deferred. 50,

Case No.:73/4/82-

; ALC4/2015 Party Name:VIVIMED LABS LIMITED MeetNo/Date:5/82- i ALC4/20I7 i 25.10.2017 i Status:Deferred; HQ File :01/82/050/00112/AM16/ 1 RLA File :09/24/040/00700/AM]5/ Lic.No/Date:091006182li 31.03.2015 1 Defer Date:13.12.2017- ( Decision: Deferred. 1 1 511 i

Case No.:52/4/82-

; ALC4/2015 1 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:5/82- 1 ALC4/2017 : 25.10.2017 , Status:Deferred' HQ File :01/82/050/00091/AM16/ ; RLA File :05/24/040/00562/AM15/ Lic.No/Date:0510393822' 01.04.2015 Defer Date: 10.01.2018 'Decision: Deferred. 52' CaseNo.:88/4/82- ALC4/2015 Party Name:INDO AMINES LIMITED Meet No/Date:5/82- ! ALC4/2017 25.10.2017 Status:Deferred HQ File :01/82/050/00127/AM16/ I RLA File :03/94/040/01218/AM15/ Lic.No/Date:0310795135| 07.04.2015 ; Defer Date: 10.01.2018 Decision: Deferred. 53: i 1 CaseNo.:80/4/82- ALC4/2015 Party Name:VINS BIOPRODUCTS LTD., Meet No/Date:5/82- ALC4/2017 25.10.2017 i Status:Deferred HQ File i :01/82/050/00119/AM16/ RLA File :09/24/040/00652/AM15/ Lic.No/Date:0910061882' 15.04,2015 Defer Date:13.12.2017 Decision : Deferred. 54,

Case No.:76/4/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred

^QFile ;I 01/82/050/00115/AM16/ U.A File 11 09/24/040/00717/AM15/ ! Jc.No/Date:0910061893}I 17.04.2015 _ Defer Date: LO.01.2018 !iDecision: Deferred. . — ^ .. [ 55' [^ase No.:77/4/82- ] ALC4/2015 ^arty Name:VIVIMED j LABS LIMITED | ; vIeetNo/Date:5/82- i ALC4/2017 25.10.2017 _ _j Status:Deferred, HQ File :01/82/050/00116/AM16/ ' RLA File ;09/24/040/00738/AM15/ ' Lic.No/Date:0910061892j 17.04.2015 ; Defer Date: 10.01.2018 Decision : Deferred. .

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Case No.:83/4/82-

1 ALC4/2015 ! Party i Name:CONTINENTAL ; CHEMICALS i MeetNo/Date:5/82- } ALC4/2017 1 25.10.2017 J Status:Deferred HQ File :01/82/050/00122/AM16/ RLA File :08/24/040/00005/AM16/ Lic.No/Date:0810135094! 24.04.2015 ! Defer Date: 10.01.2018 Decision : Deferred.

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Case No.:15/7/82-

ALC4/2015 Party Name:MAHAVlR SYNTHESIS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferredi ,HQ File ; :01/82/050/00620/AM16/ ' RLA File ' :52/24/040/00007/AM16/ ; Lic.No/Date:5210041517 i 11.05.2015 Defer Date: 10.01.2018 Decision : Deferred. . ^ .

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  • — i 58 CaseNo.:129/7/82- i ALC4/2015 Party Name:NATIONAL | TUBE INDUSTRIES, ! 1 MeetNo/Date:5/82- j ALC4/2017 ^ 25.10.2017 i 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:13.12.2017 Decision : Deferred.

^ ^—1 1 i

Case No.: 102/7/82-

ALC4/2015 Party Name:DYNAMIC I SPECIALITY : CHEMICALS LIMITED Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred 59,HQ File :01/82/050/00707/AM16/ RLA File :30/24/040/00006/AM16/ , Lic.No/Date:3010103498! 21.05.2015 : Defer Date: 10.01.2018 1 Decision : Deferred.

——i—=—

j CaseNo.:55/13/82- ALC4/201S Party Nanie:GLOBAL 1 CALCIUM PRIVATE LIMITED, Meet No/Date:5/82- ALC4/2017 25.10.2017 StatusrDeferred' 60 HQ File :01/82/050/01018/AM16/ RLA File :07/24/040/00036/AM16/ Lic.No/Date:0710108251 22.05.2015 Defer Date: 10.01.2018 ! Decision: Deferred. .. .. ~ ^ 10

1

Case No.:60/20/82-

ALC4/2016 Party NameiGLOBAL CALCIUM PRIVATE Meet No/Date: 5/82- ALC4/2017 Status:Deferredj 61 1 LIMITED, 25.10.2017 ; HQ File :01/82/050/01237/AM17/ RLA File ;07/24/040/00037/AM16/ Lic.No/Date:0710108250 22.05.2015 Defer Date: { 10.01.2018 ; Decision: Deferred. i . _

Case No.: 110/7/82-

ALC4/2015 Party Name:RISHABH METALS & Meet No/Date: 5/82- ALC4/2017 Status:Deferred' |62 i . CHEMICALS PVT LTD 25.10.2017 HQ File :01/82/050/00715/AM16/ RLA File :03/95/040/00051/AM16/ Lic.No/Date:0310796383 03.06.2015 J Defer Date:13.12.2017 ] Decision: Deferred. || : i , CaseNo.:17/7/82- ALC4/2015 Party Name:SUN PHARMACEUTICAL Meet No/Date: 5/82- ALC4/2017 Status:Deferred . JINDUSTRIES LTD., 25.10.2017 ; ) 63 HQ File ' :01/82/050/00622/AM16/ ; RLA File ;05/24/040/00078/AM16/ Lic.No/Date:0510394418! 03.06.2015 ! Defer | Date:I3.12.2017! Decision : The Committee noted that information has been called for from the firm in NC meeting | No.02/82 dated 13.09.2017 is awaited. The Committee accordingly decided await the reply and j deferred the case. ! I ; Case No.:60/4/82- i ALC4/2016 Party NameiADCOCK INGRAM LTD, Meet No/Date;5/82- ALC4/2017 25.10.2017 ' StatusrDeferred; .64 HQ File 1 :01/82/050/00123/AM17/ : RLA File :07/24/040/00071/AM16/ ' Lic.No/Date:071010835L 10.06.2015 1 Defer ! Date:I3.12.2017' 1[ Decision : The Committee noted that information has been called for from the firm in NC meeting j No.02/82 dated 13.09.2017 is awaited. The Committee accordingly decided await the reply and deferred the case. .... ( CaseNo.:48/19/82- ALC4/2015 Party NameiRAJ DHANVANTRY Meet No/Date:5/82- ALC4/2017 ! Status:Deferred| i65! 1 PHARMACY 25.10.2017 HQ File ; :01/82/050/01529/AM16/ ! RLA File :24/24/040/00007/AM16/ Lic.No/Date:2410041748| 15.06.2015 Defer Date:13.12.2017' 1

  • ^ Decision: Deferred. «

, _

Case No.:41/13/82-

ALC4/2015 Party Mame: D ANOPH ARM CHEMICALS PRIVATE Meet No/Date:5/82- ALC4/2017 25.10.2017 StatusrDeferred 66! LTD. r HQ File 01/82/050/01004/AM16/ RLA File 03/94/040/00111/AM16/ I Lic.No/Date:0310796667i 16.06.2015 Defer Date:13.12.2017' J Decision: Deferred. 11

--

  • in-: ^ jCase No,:108/14/82- ALC4/2015 ^arty Name:VIVIMED | LABS LIMITED i vIeetNo/Date:5/82- ] ALC4/2017 j 25.10.2017 1 Status:Deferred' HQ File 1 •01/82/050/01244/AM16/ : RLA File " ! :09/24/040/a0183/AM16/ j Lic.No/Date:0910062267| 01.07.2015 ^ J Defer Date; 10.01.2018 {Decision : Deferred. , Case No.:10/13/82- • ALC4/2015 Party Name:AMINES & ' PLASTICIZERS LIMITED Meet No/Date*.5/82- ' ALC4/2017 25.10.2017 Status:Deferredi . HQ File ! ;01/82/050/00973/AM16/ RLA File :03/94/040/a0229/AM16/ Lic.No/Date:0310797018 02.07.2015 Defer Datel0.0l.2018 : Decision: Deferred.

— ^ " j 1 1

Case No.:ll/13/82-

ALC4/2015 j Party Name:AMINES & j PLASTICIZERS j LIMITED _ _! Meet No/Date:5/82- 1 ALC4/2017 i 25.10.2017 ; StatusiDeferredi 69iHQ File ■01/82/050/00974/AM16/ ^ RLA File :03/94/040/00228/AM16/ Lic.No/Date:03107970201 02.07.2015 Defer Date; 10.01.2018 i JDecision: Deferred.

  • "

^ 70 CaseNo.:24/13/82- ; ALC4/2015 Party j Name:DANOPHARM j CHEMICALS PRIVATE | LTD. J Meet No/Date;5/82- | ALC4/2017 1 25.10.2017 i Status:Deferredi HQ File ;01/82/050/00987/AM16/_ Decision : Deferred. RLA File ' :03/94/040/00226/AM16/ Lic.No/Date:0310797092 07.07.2015 Defer Date:13.12.2017 i 1 1 Case Nq.:61/20/82- i ALC4/2016 1 Party Name:GLOBAL { CALCIUM PRIVATE j LIMITED, ' MeetNo/Date;5/82- i ALC4/2017 1 25.10.2017 J Status:Deferredi 71i 1 1 1 i HQ File :01/82/050/01238/AM17/ ' RLA File ' :07/24/040/00115/AM16/ Lic.No/Date:0710108490| 08.07.2015 Defer Date: 10.01.2018 1

    • — -—=—^— D „ j ecision: Deferred. 72

Case No.:20/16/82-

ALC4/2015 Party Name;MYLAN ; LABORATORIES j LIMITED MeetNo/Date:5/82- { ALC4/2017 25.10.2017 _J 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;13.12.2017' information has been called for from the turn m IS I. meeting, No.02/82'dated 13.09.2017 is awaited. The Committee accordingly decided await the reply and , j deferred the case. _

  • --—- llMeet No/Date-^- J|Status:Deferredj 12

ALC4/2015 I INDASILIFESCIENCES PVTLTD ALC4/2017 25.10.2017 ; 1 HQ File ;0I/82/050/00985/AM16/ RLA File :03/94/040/00282/AM16/ Lic.No/Date:0310797355 17.07.2015 Defer Date:13.12.2017i Decision: Deferred. 74

Case No.:n5/13/82-

ALC4/2015 Party Name:FERMENTA BIOTECH LTD., Meet No/Date:5/82- ALC4/2017 25.10.2017 StatusrDeferred' HQ File :01/82/050/01078/AM16/ RLA File :03/94/040/00038/AM16/ Lic.No/Date:0310797627 24.07.2015 Defer Date:13.12.2017 1

  • jDecision: Deferred.

— ^ 75

Case No.:73/8/82-

ALC4/2015 j Party Name:RECKITT BENCKISER HEALTHCARE INDIA , LIMITED Meet No/Date:5/82- ; ALC4/2017 25.10.2017 1 Status:Deferred; 1 HQ File i :01/82/050/00869/AM16/ | RLA File :05/24/040/00213/AM16/ Lic.No/Date:0510395102! 28.07.2015 .

.J Defer ; Date:13.12.2017j !Decision: Deferred. 76l
CaseNo.:116/13/82- ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred' HQ File , :0J/82/050/01079/AM16/ , RLA File ;03/94/040/00215/AM16/ i Lic.No/Date:0310797864 31.07.2015 Defer Date: 10.01.2018 j i .J Decision: Deferred. j 77 CaseNo.:112/13/82- ALC4/2015 Party Name:K V AROCHEM PVT. LTD 1 Meet No/Date:5/82- | ALC4/2017 ' 25.10.2017 Status:Deferred! 1 HQ File , :01/82/050/0IO75/AM16/ ' RLA File :03/94/040/00345/AM16/ Lic.No/Date;031079793 7
04.08.2015 1 Defer Date: 10.01.2018 f Decision: Deferred. 78i CaseNo.:12/18/82- ALC4/2015 Party Name:OMTECH CHEMICAL INDUSTRIES PVT.LTD. Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred' HQ File :0I/82/050/01477/AM16/ ' RLA File ;03/95/040/00345/AM16/ ' Lic.No/Date:0310797967' 05.08.2015 Defer Date: 10.01.2018 1

  • , 1 Decision : Deferred. 79

Case No.:50/13/82-

ALC4/2015 Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferredi 1 HQ File RLA File Lic.No/Date:0410160884i Defer Date: 13

,pni/89;n'in/01013/AM16r|:04/24/040/00095/AMT^;|06.08.2015 10.01.2018

Case No.:111/13/82-

ALC4/2015 801 Party NameiHEMA DYE CHEMPVT.LTD. HQ File :01/82/050/01074/AM16/ ; RLA File :03/94/040/00305/AM16/ Meet No/Date:5/82- ALC4/2017 25.10.2017 StatusiDeferred Lic.No/Date:0310798134) 13.08.2015 Defer Date: 10.01.2018 Decision: Deferred. [ 1 1 1 CaseNo.:79/13/82- ALC4/2015 Party Name:AMI ORGANICSPVTLTD. ! Meet No/Date:5/82- 1 ALC4/2017 25.10.2017 _ ' StatusrDeferred 81 HQ File •01/82/050/01042/AM16/ ' RLA File :52/24/040/00034/AM16/ Lic.No/Date:5210041610i 14.08.2015 Defer Date: 10.01.2018 Decision: Deferred. Status:Deferred' CaseNo.:127/13/82- ALC4/2015 LIFESCIENCES LTD., RLA File •03/94/040/00878/AMl 5/ HQ File 17.08.2015 •01/82/050/01090/AM16/ • Decision: Deferred. ALC4/2017 25.10.2017 Lic.No/Date:03107982051 Defer Date:13.12.2017 83

Case No.:126/13/82-

ALC4/2015 Party Nanie:ASTEC ' LIFESCIENCES LTD., | Meet No/Date;5/82- ALC4/2017 25.10.2017 Status:Deferred' HQ File :01/82/050/01089/AM16/ RLA File :03/94/040/00879/AM15/ Lic.No/Date:0310798319; 20.08.2015 ' Defer Date:13.12.2017 _ .. - - - :

1 ! 2ase No.:161/13/82- ^ ALC4/2015 ^arty Name;STERLING ' AUXILIARIES PVT j LTD J vIeetNo/Date:5/82- j ALC4/2017 ; 25.10.2017 J Status:Deferred| 84 HQ File i •01/82/050/01124/AM16/ • RLA File i ;03/95/040/00274/AM16/ j Lic.No/Date:0310798374; 21.08.2015 Defer Date; 10.01.2018 1 . . -1 Decision : Peferred.

    • — -- - --— ^ ^

Case No.:59/ll/82-

ALC4/2016 Party Name:AMI ' ORGANICS PVT LTD. Meet No/Date:5/82- ALC4/2017 25.10.2017 _ Status:Deferred 85 HQ File •01/82/050/00593/AM17/ RLA File :52/24/040/00040/AM16/ Lic.No/Date:5210041626 04.09.2015 Defer Date: 10.01.2018 |Decision : Deferred. ^— 14

1 186 1

Case No.:5/18/82-

ALC4/2015 Party Name:AMI ORGANICS PVTLTD. Meet No/Date;5/82- ALC4/2017 25.10.2017 Status:Deferred: HQ File :01/82/050/01470/AM16/ RLA File :52/24/040/00039/AM16/ Lic.No/Date:5210041625 04.09.2015 Defer Date: : 10.01.2018 J I Decision: Deferred. < I CaseNo.:118/14/82- ALC4/2015 _

_ _ Party Name:SHASUN PHARMACEUTICALS UMITED Meet No/Date:5/82- ALC4/2017 25.10.2017 StatusrDeferredl 1 1 1 '87 1 HQ File :01/82/050/OI254/AM16/ RLA File :04/24/040/00139/AM16/ I Lic.No/Date:0410161045 22.09.2015 Defer | Date:13.12.2017! ! Decision : The Committee noted that information has been called for from the firm in NC meeting 1 No.02/82 dated 13.09.2017 is awaited. The Committee accordingly decided await the reply and i deferred the case. 88 CaseNo.:86/14/82- ALC4/2015 1 Party NamerBELLAPREMIER HAPPY HYGIENECARE PRIVATE LIMITED Meet No/Date:5/82- ' ALC4/2017 1 25.10.2017 ; . -.J StatusiDeferred' HQ File , :0I/82/050/01222/AM16/ RLA File :35/24/040/00005/AM16/ Lic.No/Date:3510044794} 25.09.2015 1 Defer ! Date:17.05.2017l .J Decision: Deferred. _ 89 CaseNo.:62/20/82- j ALC4/2016 1 1 , _ 1 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:5/82- | ALC4/2017 25.10.2017 ' StatusrDeferredj j 1 t HQ File :01/82/050/0I239/AM17/ ' RLA File ; :07/24/040/00220/AM16/ ' Lic.No/Date:0710108925i 20.10.2015 j Defer Date: 10.01.2018 1 _j Decision : Deferred. I _ .

. 90

Case No.:77/16/82-

1 ALC4/2015 1 f Party Name:LACTOSE (INDIA) LTD., Meet No/Date:5/82- ' ALC4/2017 25.10.2017 ! Status:Deferredi HQ File :qi/82/050/01397/AMI6/ RLA File ! :03/95/040/00481/AM16/ Lic.No/Date:0310799561| 20.10.2015 Defer Date:13.12.2017' ^

Decision: Deferred. ^ . 9l| ! CaseNo.:140/13/82- ALC4/2015 ; Party Name:SURVrVAL : TECHNOLOGIES PVT.LTD. Meet No/Date:5/82- ' ALC4/2017 ! 25.10.2017 Status:Deferredi 1 HQ File :0_l/82/050/01103/AMI6/ RLA File ;03/95/040/00503/AM16/ ^ Lic.No/Date:0310799583 21.10.2015 Defer Date: 10.01.2018 _ i Decision: Deferred. .

. 92i Case No.: 141/13/82- Party NameiSURVIVAL Meet No/Date:5/82- StatuszDeferred 15

... .. .

—

~ — — I. :ALC4/2015 ;TECHNOLOGIES ; PVT.LTD. 1 ALC4/2017 1 25.10.2017 _ _ j i HQ File j 1 -.01/82/050/01104/AM16/ RLA File ' :03/95/040/00504/AM16/ i Lic.No/Date:0310799629! 23.10.2015 J Defer Date: 10.01.2018 ' Decision: Deferred. . i' ' 1 1

Case No.:63/20/82-

, \LC4/2016 < j] ^arty Name:GLOBAL , 1 CALCIUM PRIVATE LIMITED, vleetNo/Date:5/82- ,v \LC4/2017 Z5.10.2017 5tatus:Deferred ,93i
1 HQ File i •01/82/050/01240/AM17/ . ILA File 1 07/24/040/00116/AM16/^j Lic.No/Date:0710108958| 27.10.2015 j Defer Date: 10.01.2018 ; i npricinn: Deferred. _

Case No.:142/13/82-

! ALC4/2015 1 Party NameiSYNTHO j CHIRALS PVT. LTD j Meet No/Date: 5/82- ^ ALC4/2017 i 25.10.2017 : StatusiDeferred! i94 ] HQ File •01/82/050/01105/AM16/ RLA File j :09/24/040/00443/^16/ ^ Lic.No/Date:09100627741 27.10.2015 _ ' Defer Date: 10.01.2018 ppokion ! Deferred.

^

-- 1

Case No.:136/14/82-

ALC4/2015 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:5/82- ALC4/2017 25.10.2017_ Status:Deferred !95 HQ File :01/82/050/01272/AM16/ 1 RLA File ' ;05/23/040/00293/^16/_ 1 Lic.No/Date:0510396078 130.10.2015 Defer Date:13.12.2017 rm ?n "MP mftftttTH? Decision: The Co No.02/82 dated 13 deferred the case. is awaited. The Committee accordingly decided await the reply and ir : ^ :

Case No.:64/19/82-

' \LC4/2015 'arty Name:INDO | AMINES LIMITED | 1 vleet No/Date:5/82- ALC4/2017 1 25.10.2017 ' StatustDeferredi 196, ; 1 ' i HQ File 1 01/82/050/01545/AM16/ 1 RLA File j :03/94/040/00240/AM16/ ] Lic.No/Date:0310799907j 30.10.2015 1 Defer Date; , 10.01.2018 1 Decision: Deferred.

^ ^ —= ^ ! 1 ' i , 1

Case No.:65/19/82-

, ALC4/2015 Party Name:INDO AMINES LIMITED Meet No/Date: 5/82- j ALC4/2017 ! 25.10.2017 1 StatusiDeferredi 197'HQ File •01/82/050/01546/AM16/ RLA File Lic.No/Date:0310799906 Defer Date: :03/94/040/00059/^16/ 30.10.2015 10.01.2018 I - - I I — — —- ' ^ 'r^ l98 Case Nd.:38/21/82- ALC4/2015 Party Name:VINS ,BIOPRODUCTSLTD., Meet No/Date:5/82- |ALC4/2017 125.10.2017 StatusrDeferred J

—

  • — — 16

; HQ File :0I/82/050/01743/AM16/ RLA File :09/24/040/00442/AM16/ Lic.No/Date:0910062831 03.11.2015 Defer Date:I3.12.2017 Decision: Deferred. 1 1 1 99 CaseNo.:159/13/82- 1 ALC4/2015 1 i
Party Name:CHEMCON SPECIALITY CHEMICALS P LTD Meet No/Date: 5/82- ALC4/2017 25.10.2017 Status;Deferred| HQ File I :01/82/050/01122/AM16/ j RLA File :34/24/040/00205/AM16/ Lic.No/Date:3410041650 04.11.2015 Defer Date: | 10.01.2018 i Decision: Deferred. 1 .

. _ 100 j

Case No.:57/19/82-

ALC4/2015 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:5/82- ALC4/2017 25.10.2017 Statu$;Deferred| 1 HQ File :0I/82/q_5_0/01538/AM16/ RLA File :03/94/040/00443/AM16/, Lic.No/Date:0310800060 05.11.2015 Defer Date: j 10.01.2018 ! , , Decision: Deferred. : .

_ . _ i ioi Case No.; 18/21/82- ALC4/2015 ; 1 Party NameiBHAGIRADHA CHEMICALS & 1 INDUSTRIES LIMITED, Meet No/Date:5/82- | ALC4/2017 ! 25.10.2017 ; 1 Status;Deferred| : 1 HQ File 1 :01/82/050/01723/AM16/i RLA File i :09/24/040/00487/AM 16/: Lic.No/Date:0910062841! 06.11.2015 J Defer Date: 10.01.2018 Decision: Deferred. , no2 i 1 i

Case No.:58/19/82-

ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:5/82- ^ ALC4/2017 25.10.2017 J Status;Deferred| i HQ File 1 :01/82/050/01539/AM16/! RLA File :03/94/040/00572/AM16/i Lic.No/Date:03108003241 19.11.2015 ! Defer Date: 10.01.2018 1 , 1 .. J Decision: Deferred. il03 « 1 ' ! Case No.; 104/16/82- ALC4/2015 ! Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:5/82- ! ALC4/2017 25.10.2017 Status:Deferred, HQ File :0I/82/050/01424/AM16/i RLA File :05/23/040/00339/AM16/ Lic.No/Date:0510396384l 20.11.2015 Defer Date: 10.01.2018 1 Decision; Deferred. .

1 104 (

Case No.:20/19/82-

ALC4/2015 Party Name:VDH CHEM' TECH PVT. LTD. Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred HQ File :01_/82/050/01500/AM16/i RLA File 05/24/040/00369/AM16/ Lic.No/Date:0510396413' 24.11.2015 1 Defer Date: 10.01.2018 ] . J Decision; Deferred. 17

1 1 i CaseNo.:59/19/82- I ALC4/2015 i Parly NameiEXCEL INDUSTRIES LIMITED Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred! lUb> 1 HQ File i •01/82/050/01540/AM16/; RLA File 1 :03/94/040/00251/AM16/J Lic.No/Date;03108005361 01.12.2015 ; Defer Date: 10.01.2018 1 De^'winn : Deferred. _ _ ^

—

!Case No.:61/19/82- ALC4/2015 Party Name:KV AROCHEMPVT.LTD Meet No/Date:5/82- ALC4/2017 25.10.2017 StatusrDeferred 106 HQ File :01/82/050/01542/AM16/ RLA File :03/94/040/00440/AMl 6/ Lic.No/Date:0310800529 01.12.2015 Defer Date: 10.01.2018 Decision; Deferred.

Case No.:l/8/82-

ALC4/2016 107 HQ File ;01/82/050/00339/AM17/ Party NametSWATI ' MENTHOL & ALLIED CHEMICALS LTD., Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred| 1 RLA File :29/24/040/00007/AMl 6/ Lic.No/Date;2910025232 04.12.2015 Defer Date: 10.01.2018 ;< 1 \i :ase No.:89/19/82- [ I U.C4/2015 1' ] 1 'artyName:DSM I 5IN0CHEM PHARMACEUTICALS NDIAPVT.LTD. ! MeetNo/Date:5/82- j S \LC4/2017 j 25.10.2017 J 3tatus:Deferredj 108 I i iQ File 01/82/050/01570/AM16/i RLA File 22/24/040/00085/AMl 6/^ Lic.N6/Date:2210015363| 09.12.2015 i Defer Date: | 10.01.2018 i 1 Decision ; Deferred.

— ' ' 1 CaseNo.:30/19/82- ALC4/2015 ' Party Name'.PAYAL ' PETROCHEM PRIVATE LIMITED_ 1 Meet No/Date:5/82- 1 ALC4/2017 ' 25.10.2017 1 Status:Deferred| 1091 i HQ File :01/82/050/01510/AM16/j RLA File :05/24/040/00401/AM16/ Lic.No/Date:0510396611! 14.12.2015 i Defer Date: , 10.01.2018 J Decision: Deferred. — — — CaseNo.:18/19/82- ALC4/2015 Party Name:AMI ORGANICS PVTLTD. Meet No/Date:5/82- ALC4/2017 125.10.2017 Status:Deferredl '110 HQ File ' •01/82/050/01498/AM16/ RLA File 1 :52/24/040/00064/AM16/

  • Lic.No/Date;5210041711 (15.12.2015 Defer Date: , 10.01.2018 ! JOecision: Deferred. — :
    ill] Case No.:39/19/82- ALC4/2015 i Party Name:JUBILANT , LIFE SCIENCES 1 MeetNo/Date:5/82- |ALC4/2017 1 Status:Deferredl 1 ..... 18

; LIMITED 25.10.2017 ! 1 HQ File : :01/82/050/01520/AM16/.: RLA File :05/23/040/00360/AM16/ Lic.No/Date:05103966341 16.12.2015 1 Defer Date: | 10.01.2018 j Decision: Deferred. i 1 112 CaseNo.:36/19/82- ALC4/2015 Party Name:PANACEA BIOTEC LTD., Meet No/Date:5/82- ! ALC4/2017 25.10.2017 i Status:Deferred HQ File i :01/82/050/01517/AMI6/| RLA File :05/24/040/00439/AM16/' Lic.No/Date:0510396670 18.12.2015 Defer Date:13.12.2017'. ) 1 1 1 113 1 1 CaseNo.:54/21/82- ' ALC4/2015 1 Party NameiVIVIMED ] LABS LIMITED Meet No/Date:5/82- | ALC4/2017 25.10.2017 Status:Deferred| 1 HQ File ;01/82/050/01759/AM16/; RLA File j :09/24/040/00525/AM16/' Lic.No/Date:0910063015 21.12.2015 Defer Date: ' 10.01.2018 i J Decision: Deferred. 114j 1 j CaseNo.:61/21/82- ' ALC4/2015 Party Name: VrVIMED LABS LIMITED Meet No/Date: 5/82- ALC4/20I7 25.10.2017 { Status:Deferred| 1 HQ File ; ;01/82/050/01766/AM16/' RLA File :09/24/040/00547/AM16/, Lic.No/Date:0910063018 21.12.2015 Defer Date: i 10.01.2018 ! j'Decision: Deferred. ! 1 CaseNo.:22/19/82- 1 ALC4/2015 Party Name:FRESENIUS i KABI ONCOLOGY : LIMITED Meet No/Date:5/82- ALC4/2017 25.10.2017 1 Status:Deferred| 115,HQ File ! :01/82/050/01502/AMl 6/1 RLA File :05/23/040/00244/AM16/i Lic.No/Date:0510397137| 30.12.2015 i Defer Date:13.12.2017 i Decision : The Committee noted that information has been called for from the firm in NO meeting No.02/82 dated 13.09.2017 is awaited. The Committee accordingly decided await the reply and deferred the case. 116' !

Case No.:23/19/82-

ALC4/2015 Party Name;FRESENIUS; KABI ONCOLOGY LIMITED Meet No/Date:5/82- j ALC4/2017 ' 25.10.2017 i Status:Deferred HQ File :01/82/050/01503/AM16/' RLA File :05/23/040/00260/AM16/' Lic.No/Date:0510397138i 30.12.2015 I Defer Date:13.12.2017i 1 117 CaseNo.:47/21/82- ALC4/2015 Party NamerBHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date:5/82- ALC4/2017 25.10.2017 ' Status:Deferred' 19

HQ File 01/82/050/01752/AM16/' RLA File 09/24/040/00570/AM16/' Jc.No/Date:0910063087 01.01.2016 Defer Date: 10.01.2018 neeision : Deferred. — '

■lease No.:35/21/82- I ,ALC4/2015 Party Name;DEEPAK NOVOCHEM TECHNOLOGIESLTp MeetNo/Date:5/82- ' ALC4/2017 ' 25.10.2017 j Status:Deferredi jus 1 i HQ File :01/82/050/01740/AM16/: RLA File :31/83/040/00094/AM16/ Lic.No/Date:31100658431 01.01.2016 j Defer Date: 10.01.2018 j « Decision : Deferred. .

^

--- — 1 CaseNo.:2/17/82- ALC4/2015 Party Name;ARENE LIFE SCIENCES LIMITED. Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred, ill9 HQ File :01/82/050/01462/AM16/ RLA File ;09/24/040/00571/AM16/ Lic.No/Date:0910063114 08.01.2016 Defer Date:13.l2.2017' Decision : The Committee noted that information has been called tor ; ^ . :—- - ' 1 i i [:aseNo.:5/17/82- I \LC4/2015 ' ( 'arty Name:DYNAMIC SPECIALITY DHEMICALS LIMITED ' Sleet No/Date:5/82- j J \LC4/2017 25.10.2017 i StatusrDeferred: 120! 1 HQ File ;1 01/82/050/01465/AM16/' RLA File 30/24/040/00035/AM16/ Lic.No/Date:3010103695 11.01.2016 Defer Date: ■ 10.01.2018

— i CaseNo.:24/21/82- ALC4/2015 Party Name:BEST | VALUE CHEM PVT. LTD. . .i Meet No/Date: 5/82- 1 ALC4/2017 ' 25.10.2017 ^ StatusiDeferredi 121: 1 I HQ File :01/82/050/01729/AM16/. RLA File i :34/24/040/00267/AM16/j Lic.No/Date:3410041832| 28.01.2016 i Defer Date: 10.01.2018 ( ' \ Decision: Deferred.

'

  • —

ir CaseNo.:17/10/82- ALC4/2016 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:5/82- ALC4/2017 25.10.2017 StatusiDeferredi 122 iHQFile |:01/82/050/00363/AM17/ RLA File :22/24/040/00104/AM16/ Lic.No/Date:2210015407 01.02.2016 Defer Date:13.12.2017' 1

. .

il23 1 Case No.:26/21/82- ' ALC4/2015 1 1 Party Name:RONAK CHEMICALS j Meet No/Date:5/82- ' ALC4/2017 125.10.2017 StatusiDeferred HQ File 1 :01/82/050/01731/AM16/ 'RLA File :34/24/040/00273/AM16/ ' Lic.No/Date:3410041857 05.02.2016 j Defer i iDate:13.12.2017, 20

! Decision: Deferred. 124'

Case No.: 14/21/82-

ALC4/2015 Party NameiDHAMPUR SUGAR MILLS LTD Meet No/Date;5/82- ALC4/2017 25.10.2017 i StatusrDeferred HQ File :01/82/050/01719/AM16/: RLA File :05/23/040/00456/AM16/. Lic.No/Date:05103975211 08.02.2016 Defer Date: ' 10.01.2018 Decision: Deferred. ' 125 ' CaseNo.:5/19/82- ALC4/2015 Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:5/82- ' ALC4/2017 1 25.10.2017 1 StatusrDeferred HQ File :01/82/050/01485/AM16/j RLA File :08/24/040/00291/AM16/' Lic.No/Date:0810137155 08.02.2016 ! Defer Date: | 10.01.2018 ' Decision: Deferred. 126;

Case No.:62/4/82-

ALC4/2016 Party NameiSTERLING AUXILIARIES PVT LTD Meet No/Date:5/82- 1 ALC4/2017 1 25.10.2017 j StatusrDeferred HQ File :01/82/050/00125/AM]7/j RLA File :03/95/040/00568/AM16/ Lic.No/Date:0310802284 08.02.2016 ! Defer Date: 10.01.2018 Decision: Deferred. 127; 1

Case No.:8/2/82-

ALC4/2016 Party NameiGULBRANDSEN CHEMICALS PVT LTD ' Meet No/Date:5/82- ALC4/2017 25.10.2017 ! StatusrDeferred' HQ File :01/82/050/00008/AM17/; RLA File :34/24/040/00284/AM16/ Lic.No/Date:34100418701 10.02.2016 1 Defer Date: ' 10.01.2018 ...!Decision: Deferred. .

. 128' CaseNo.:lS/10/82- ALC4/2016 Party Name:INFINITY LABORATORIES PVT.LTD., Meet No/Date:5/82- ALC4/2017 25.10.2017 StatusrDeferred HQ File :01/82/050/00361/AM17/ RLA File :22/24/040/00107/AM16/ Lic.No/Date:2210015412| 10.02.2016 ' Defer Date:13.12.2017 Decision: Deferred. 1 129 1

Case No.:5/2/82-

ALC4/2016 i Party Name:MAMTA POLYCOATS Meet No/Date:5/82- ALC4/2017 25.10.2017 StatusrDeferred HQ File :01/82/050/00005/AM17/' RLA File :34/24/040/00293/AM16/ Lic.No/Date:3410041887! 16.02.2016 Defer Date: 10.01.2018 Decision: Deferred. i3o:Case No.:13/10/82- ALC4/2016 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:5/82- ALC4/2017 StatusrDeferred 21

1 25.10.2017 _ j HQ File :01/82/050/00359/AM17/ RLA File ;22/24/040/00109/AM16/! Lic.NoA)ate:22100154171 17.02.2016 Defer Date:13.12.2017 Decision : Deferred. .

^ .. "

• < 1 :ase No.: 102/19/82- 1 \LC4/2015 'arty Name:VIVIMED | LABS LIMITED Meet No/Date; 5/82- ^ kLC4/20n 25.10.2017 1 3tatus:Deferred! HQ File 01/82/050/01583/AM16/ ILA File 1 .09/24/040/00666/>^l6/; Lic.No/Date;0910063280| 17.02.2016 1 Defer Date; 10.01.2018 llDecision : Deferred. ; : ' .. I 1 1 Case No.:18/4/82- ALC4/2016 Party Name:VDH CHEM TECH PVT.LTD. 1 MeetNo/Date:5/82- i ALC4/2017 25.10.2017 Status:Deferred| 132;HQ File :01/82/050/00081/AM17/ RLA File ' ;05/24/040/00550/AM16/ Lic.No/Date:0510397711, 24.02.2016 Defer Date: 10.01.2018 Decision : Deferred. ^

--

'

Case No.:84/4/82-

ALC4/2016 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred| 133 HQ File :01/82/050/00147/AM17/ RLA File :09/24/040/00648/AMl 6/ Lic.No/Date;0910063326 126.02.2016 Defer Date: 10.01.2018 Decision : Deferred. . .■ ^ ■ 134:

Case No.:6/2/82-

ALC4/2016 Party Name:BEST ' VALUE CHEM PVT. i LTD. Meet No/Date:5/82- ALC4/2017 25.10.2017 StatusiDeferredi HQ File :01/82/050/00006/AM17/; RLA File :34/24/040/00308/AMl6/' Lic.No/Date:3410041932'^ 01.03.2016 Defer Date: 10.01.2018 Decision: Deferred.

Case No.:67/7/82-

ALC4/2016 Party Name:BIOLOGICAL ELTD Meet No/Date:5/82- ALC4/2017 ■ 25.10.2017 Status: Approved. 135 HQ File :01/82/050/00241/AM17/ RLA File ' :09/24/040/00714/AM16/ ! Lic.No/Date:0910063353l 03.03.2016 Defer Date: .

.. Decision : The Committee decided to ratity norms based on the reoo.mnendat.on ot u o Pharmaceuticals O.M.No. 35011/340/2012-PI(Norms) dated Sept. 2012, upbade^t the end^, these minutes or as applied by the finn whichever .s less under para 4.07 of HBP Vol.l.RA, 136!

Case No.:50/2/82-

ALC4/2016 Party Name:PANERA BIOTEC PVT.LTD. Meet No/Date:5/82- ALC4/2017 25.10.2017 Status-.Deferred 22

HQ File ;01/82/050/00050/AM17/ RLA File :05/24/040/00597/AMl 6/ Lic.No/Date:05103 97827 04.03.2016 Defer Date:13.12.2017 ' Decision: Deferred. ..

Case No.:66/4/82-

ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date: 5/82- ALC4/2017 25.10.2017 Status:Deferredl 1 : i37 HQ File :01/82/050/00I29/AM17/ RLA File :04/24/040/00257/AM16/ Lic.No/Date;0410161685 04.03.2016 Defer j Date:13.12.2017! ' Decision : The Committee noted that information has been called for from the firm in NC

— ^ . ^ , CaseNo.:67/4/82- ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred' 'l38, 1 ' HQ File :01/82/050/00130/AM17/' RLA File :04/24/040/00256/AM16/ Lic.No/Date:0410161684: 04.03.2016 Defer i Date:13.12.2017| i Decision : The Committee noted that information has been called for from the firm in NC i . . I 139

Case No.:57/4/82-

ALC4/2016 Party NamerCLARIANT INDIA LIMITED Meet No/Date:5/82- ALC4/2017 25.10.2017 Status;Deferred HQ File ;01/82/050/00120/AM17/' RLA File :03/94/040/01041/AM16/ Lic.No/Date:0310803137 08.03.2016 ; Defer Date: 10.01.2018 Decision: Deferred.

|140,

Case No.:7/2/82-

ALC4/2016 Party NamerSONGWON SPECIALTY CHEMICALS INDIA PVT. LTD. Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred ^ i HQ File :01/82/050/00007/AM17/ RLA File :34/24/040/00323/AM16/ Lic.No/Date:3410041954 08.03.2016 Defer Date: 10.01.2018 Decision: Deferred. .

141; 1

Case No.:55/4/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVTLTD Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred' HQ File 1 01/82/050/00118/AM17/ RLA File :03/94/040/01044/AM16/ Lic.No/Date:031080317r 09.03.2016 Defer Date:13.12.2017 Decision: Deferred. 142

Case No.:3/2/82-

ALC4/2016 i^arty NameiRONAK CHEMICALS Meet No/Date:5/82- ALC4/2017 25.10.2017 StatusiDeferred 23

HQ File :01/82/050/00003/AM17/, RLA File :34/24/040/00329/AM16/ Lic.No/Date;3410041957i 09.03.2016 Defer Date:13.12.2017 Decision: Deferred. 143

Case No.:100/7/82-

ALC4/2016 Party Name:CATAPHARMA CHEMICALS PVT. LTD., Meet No/Date: 5/82- ALC4/2017 25.10.2017 Status:Deferred HQ File :01/82/050/00274/AM17/ RLA File :31 /83/040/00174/AM16/ Lic.No/Date:3110066051, 14.03.2016 Defer Date:17.05.2017 Decision: Deferred. 144i Case No.;26/4/82- ALC4/2016 HQ File :01/82/050/00089/AM17/ Party NaiTie:BENZO CHEM INDUSTRIES PRIVATE LIMITED, RLA File -.03/94/040/01057/AM16/ Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred| Lic.No/Date:0310803376| 16.03.2016 Defer Date: 10.01.2018 Decision: Deferred. 145

Case No.:7/4/82-

ALC4/2016 Party Name:JUBILANT | LIFE SCIENCES LIMITED Meet No/Date:5/82- 1 ALC4/2017 25.10.2017 Status:Deferredi .

. HQ File ■01/82/050/00070/AM17/ RLA File :05/23/040/00468/AM16/ Lic.No/Date:0510397952| 17.03.2016 Defer Date: 10.01.2018

  • ——

Case No.:13/4/82-

ALC4/2016 14 • 6 Party Name:JUBILANT LIFE SCIENCES LIMITED HQ File :01/82/050/00076/AM 1 17/ RLA File: Deferred.05/23/040/00390/AM 16/ ALC4/2017 25.10.2017 ed Lic.No/Date:05103979' 53 17.03.2016 Defer Date: 10.01.2018 Decision: Deferred.

Case No.:85/4/82-

ALC4/2016 147' Party Name:SYNTHO CHIRALSPVT.LTD HQ File :01/82/050/00148/AM17/ RLA File :09/24/040/00742/AMl 6/1 Meet No/Date:5/82- ALC4/2017 25.10.2017 Lic.No/Date:0910063432i 18.03.2016 Status:Deferred Defer Date: 10.01.2018 ' Decision: Deferred. jCase No.:36/4/82- ALC4/2016 tax! Party Name;rNDOFlL
INDUSTRIES LTD. ; Meet No/Date:5/82- ALC4/2017 ; 25.10.2017 Status:Deferred' IIhQ File i •ni/82/050/00099/AM17/ RLA File | :03/94/040/01056/AMl6/i Lic.No/Date;0310803468; 21.03.2016 _ i Defer Date; 10.01.2018 24

I Decision: Deferred.

Case No.:81/4/82-

ALC4/2016 Party Name:SURVIVAL TECHNOLOGIES Meet No/Date:5/82- ALC4/2017 Status:Deferred, 1 149 ! 1 PVT.LTD. 25.10.2017 1 HQ File :0I/82/050/00144/AM17/ RLA File :03/95/040/00984/AM16/ Lic.No/Date:0310803500 22.03.2016 Defer Date: 1 10.01.2018 i j Decision: Deferred. j. - .

Case No.:50/4/82-

ALC4/2016 Party Name:AVA CHEMICALS Meet No/Date:5/82- ALC4/2017 Status:Deferredi 150' 1 1 PVT.LTD, 25.10.2017 ; HQ File 1 :01/82/050/00113/AM17/ RLA File :03/94/040/01070/AM16/ Lic.No/Date:0310803526i 23.03.2016 Defer Date: ! 10.01.2018 Decision: Deferred.

Case No.:186/10/82-

ALC4/2016 Party Name:VOVANTIS LABORATORIES PVT ' Meet No/Date:5/82- ALC4/2017 1 Status:Deferredf 1 151 I LTD 25.10.2017 HQ File :01/82/050/00532/AM17/: RLA File :34/24/040/00290/AM 16/ Lic.No/Date:34100420211 30.03.2016 Defer i Date:13.12.2017, —jDecision: Deferred.

Case No.:43/4/82-

ALC4/2016 Party Name:AARTl INDUSTRIES LIMITED Meet No/Date:5/82- ALC4/2017 Status:Deferred' 152' 25.10.2017 J HQ File ;01/82/050/00106/AM17/' RLA File 03/94/040/01108/AMI6/' Lic.No/Date:0310803663! 31.03.2016 1 Defer | Date:13.12.2017| 153

Case No.:76/4/82-

ALC4/2016 Party Name:METROPOLITAN EXIMCHEM PRIVATE ^ LTD. Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred HQ File :01/82/050/00139/AM17/' RLA File :03/95/040/0I015/AM16/ Lic.No/Date:0310803 674' 31.03.2016 Defer Date: 10.01.2018 Decision: Deferred.

.... . _ _ 1 i ' 1 CaseNo.:8/10/82- ALC4/2016 Party Name:BLUE CIRCLE ORGANICS ^ PVT. LTD. Meet No/Date:5/82- 1 ALC4/2017 25.10.2017 Status:Deferred 1 1 154jHQ File :01/82/050/00354/AM17/ RLA File :03/94/040/00645/AM16/ Lic.No/Date:0310803722' 01.04.2016 Defer Date: 10.01.2018 1 Decision : 1 he Committee decided to send copy of application to DIPP (Chemicals) for their comments. 25

Case No.:92/4/82-

ALC4/2016 [party Name:S WATl MENTHOL & ALLIED CHEMICALS LTD., 1551 j Meet No/Date:5/82- ALC4/2017 ;25.10.2017 Lic.No/Date:29100252441 106.04.2016 Status:Deferred| Defer Date: 10.01.2018 156

Case No.:86/4/82-

ALC4/2016 Party Name:AMI I ORGANICS PVT LTD. i 1 Meet No/Date:5/82- ' ALC4/2017 25.10.2017 _ .j Status:Deferred HQ File ;01/82/050/00149/AM17/' RLA File ;52/24/040/00001/AM17/ Lic.No/Date:5210041862i 19.04.2016 . ' Defer Date: 10.01.2018 i Case No.:164/10/82- ALC4/2016 Party Name:GLAND PHARMA LIMITED

Case No.:7/6/82-

ALC4/2016 158! Party NameiMANGALAM ORGANICS LIMITED (FORMERLY DUJODWALA ' ;0?/82/050/00174/AM17/ :03/95/'o40/OQ013/AM_17/'l Lic.No/Date:0310804365 03.05.2016 Defer Date:13.12.2017 159: Decision: Deferred.

Case No.:174/10/82-

[Party Name:FRESENlUS i ALC4/2016 KABI ONCOLOGY [limited Meet No/Date:5/82- ALC4/2017 25.10.2017 , StatusiDeferred HO File [RLA File ■01/82/050/00520/AM17/l:05/23/040/00038/AM17/ Uc.No/Date:0510398377l 04.05.2016 Defer Date:13.12.2017

Case No.:175/10/82-

jParty NameiKU ALC4/2016 .PLASTICIZERS ILIMITED Meet No/Date:5/82- ALC4/2017 25.10.2017 Lic.No/Date:0510398379i 04.05.2016 Defer Date: 10.01.2018 1601 RLAFile HO File i :01 /82/050/00521/.^17/ |:05/23/040/0003^2/AM17/| [Decision: Deferred. Status:Deferred Meet No/Date:5/82 Party Name:ALEMBlC CaseNo.:181/10/82- PHARMACEUTICALS ALC4/2017 161 ALC4/2016

, 1 HQ File :01/82/050/00527/AM17/ RLAFile :34/24/040/00021/AM17/ Lic.No/Date;34l0042142 05.05.2016

Defer | Date:13.12.2017; Decision: Deferred. j I l62 CaseNo.:146/10/82- ALC4/2016 Party NameiPORUS LABORATORIES PVT LTD Meet No/Date;5/82- ALC4/2017 25.10.2017 Status:Deferred HQ File ;01/82/050/00492/AM17/: RLA File :09/24/040/00044/AM17/ Lic.No/Date:0910063608 09.05.2016 Defer Date: i 10.01.2018 ' i ' l63; « 1 1 CaseNo.:169/10/82- i ALC4/2016 1 I Party Name:BIOLOGICAL E , LTD Meet No/Date:5/82- ' ALC4/2017 25.10.2017 Status:Deferred 1 HQ File 1 :01/82/050/00515/AMI7/ RLA File ;09/24/040/00007/AM17/ Lic.No/Date:0910063629i 17.05.2016 Defer | Date:13.12.2017| Decision: Deferred. 1 ! 164 ! 1 CaseNo.:126/10/82- ALC4/2016 _ 1 Party Name:BIOLOGICAL E LTD Meet No/Date:5/82- | ALC4/2017 1 25.10.2017 ' Status:Deferred| HQ File :01/82/050/00472/AM17/i RLA File :09/24/040/00306/AM15/ Lic.No/Date;0910063657 19.05.2016 Defer ; Date:13.12.2017, 'Decision: Deferred. , 165i CaseNo.:149/10/82- ALC4/2016 Party NamerBIOLOGICALE ' LTD Meet No/Date;5/82- | ALC4/2017 ; 25.10.2017 j Status:Deferredi HQ File :01/82/050/00495/AM17/i RLA File :09/24/040/00546/AM16/ Lic.No/Date:0910063659! 19.05.2016 1 Defer i Date:13.12.2017' j Decision: Deferred. 166; ! 1 1

Case No.:72/10/82-

ALC4/2016 Party Name:V.D.H. ORGANICS PVT. LTD ' Meet No/Date:5/82- 'i ALC4/2017 25.10.2017 I Status:Deferred! HQ File 1 :01/82/050/00418/AMI7/| RLA File :05/24/040/00080/AM17/i Lic.No/Date:0510398561 19.05.2016 Defer Date: 10.01.2018 j Decision: Deferred. J 167,

Case No.:73/10/82-

' ALC4/2016 Party Name;VDH CHEMi TECH PVT. LTD. Meet No/Date:5/82- i ALC4/2017 25.10.2017 Status:Deferredi HQ File :01/82/050/00419/AM17/ RLA File :05/24/040/00067/AM17/' Lic.No/Date:0510398560i 19.05.2016 ; Defer Date: 10.01.2018 Decision ; Deferred. 27

168;

Case No.:2/5/82-

ALC4/2016 Party Name: ACEBRIGHT | (INDIA) PHARMA PVT ] LTD, ; Meet No/Date:5/82- ALC4/2017 25.10.2017 Status: < Approved 1 HQ File :01/82/050/00161/AM17/ RLA File :07/24/040/0003 6/AM17/ 1 Lic.No/Date:0710109851, 20.05.2016 _ Defer Date: Decision : The Committee decided to ratify norms based on the recominenddtiui. ot iJ/u Pharmaceuticals O.M.No. 3501 l/97/2016-PI(Norms) dated July 2016 these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. CaseNo.:79/10/82- ALC4/2016 1691 HQ File ;01/82/050/00^5/AM17/ Party Name:FRESENIUS KABI ONCOLOGY ] LIMITED 1 Meet No/Date:5/82- ALC4/20I7 1 25.10.2017 , Status: Approved; RLA File i :05/23/040/00075/AM17/ l Lic.No/Date:05103 985 81 24.05.2016 Defer Date: nn nf D/oi Decision : The Committee deciaea to rainy ^ T T" Pharmaceuticals O.M.No. 3501 l/287/2016-PI(Noniis) dated 26,092016 uploaded at these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1, concerned may take necessajy action^^ per decision of NC. _ ^ 170

Case No.:74/10/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD

  • ! Meet No/Date: 5/82- , ALC4/2017 25.10.2017_ _ ; Status: Approved j HQ File :01/82/050/00420/AM17/ RLA File ^ :05/23/040/00078/AM17/ j Lic.No/Date:0510398583' 24.05.2016 Defer Date: Decision : The Committee decided to ratify norms based on tne recommeiidal.011 ul u™, ^Pharmaceuticals O.M.No. 3501I/296/2016-PI(Norms) dated 26.09-2017, uploaded at 'l these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.l.RA, . concerned may take necessary action as perjecision of NC. ^ ^ ^ 1 i CaseNo.:185/10/82- ALC4/2016 Party Name:PAUSHAK S LIMITED 1 i VIeet No/Date:5/82- | ALC4/2017 1 25.10.2017 Status:Deferred^ , 17l| : 1 HQ File :01/82/050/00531/AM17/' RLA File , :34/24/040/00037/AM17/i Lic.No/Date:3410042207l 25.05.2016 Defer Date: 10.01.2018 1 . _

1 ( 1 i , CaseNo.:102/10/82- ALC4/2016 Party Name:IKRISH j HEALTHCARE | PVT.LTD., J MeetNo/Date:5/82- I ALC4/20I7 : 25.10.2017 _ J Status:Deferredi 172 , |HQ File l;01/82/050/00448/AM17/ RLA File :05/23/040/00091/AM17/ Lic.No/Date:0510398628; 26.05.2016 Defer Date:I3.12.2017 i 1 iDecision : Deferred.

• — ! 1173

Case No.:65/10/82-

iALC4/2016 1 Party Name:KORES (INDIA) LTD. i Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferredi 28

I HQ File :qi/82/050/00411/AM17/ RLA File :31/83/040/00014/AM17/ Lic.No/Date:3110066163! 26.05.2016 Defer Date: 10.01.2018 :Decision: Deferred. 1 174; CaseNo.:112/10/82- ! ALC4/2016 1 Party Name:FRESENIUSi KABI ONCOLOGY ! LIMITED Meet No/Date: 5/82- ! ALC4/2017 1 25.10.2017 1 Status:Deferred HQ File :01/82/050/00458/AM17/: RLA File :05/23/040/00094/AM17/' Lic.No/Date:0510398655l 27.05.2016 1 Defer Date:13.12.2017 Decision: Deferred. ' * CaseNo.;36/10/82- ALC4/2016 t Party Name:FRESENIUS KABI INDIA PRIVATE LTD Meet No/Date:5/82- ALC4/2017 25.10.2017 ; Status: Approved! 175^ HQ File :01/82/050/00382/AM17/ RLA File :03/94/040/00145/AM17/ Lic.No/Date:0310805018' 30.05.2016 1 Defer Date: j Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals O.M.No. 35011/286/2016-PI^orms) dated 26.09.2017, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RAi I 176; I

Case No.:35/10/82-

ALC4/2016 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:5/82- | ALC4/2017 25.10.2017 StatusrDeferred! HQ File :01/82/050/00381/AM17/ RLA File :03/94/040/00030/AM17/ Lic.No/Date:0310805009. 30.05.2016 Defer Date: 10.01.2018 1 i 177, CaseNo.:123/10/82- ALC4/2016 Party Name:NIFTY LABS PVTLTD., Meet No/Date:5/82- ALC4/2017 25.10.2017 StatusiDeferred HQ File ; ;qi/82/050/00469/AM17/j RLA File :09/24/q40/00102/AM17/ Lic.No/Date:0910063716' 30.05.2016 ; Defer Date:13.12.2017 Decision: Deferred. 178! CaseNo.:103/10/82- ALC4/2016 Party Name;AGSON GLOBAL PRIVATE LIMITED. Meet No/Date:5/82- ALC4/2017 25.10.2017 StatusiDeferred HQ File :01/82/050/00449/AM17/' RLA File :05/23/040/00095/AM17/' Lic.No/Date:05103986801 31.05.2016 ! Defer Date: 10.01.2018 'Decision : Deferred. 179'

Case No.:51/10/82-

ALC4/2016 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:5/82- ALC4/2017 25.10.2017 StatusiDeferred HQ File RLA File Lic.No/Date:0310805264'Defer Date: 29

|:01/82/050/00397/AM17/ |:03/94/Q40/00196/AM17/||07.06.2016 10.01.2018 Decision: Deferred. 1801 CaseNo.;129/10/82- ALC4/2016 HQ File :01/82/050/00475/AM17/ Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:5/82- ALC4/2017 25.10.2017 RLA File :09/24/040/00045/AM17/ StatusiDeferred Lic.No/Date;0910063759l 07.06.2016 Defer Date:13.12.2017

Case No.:134/10/82-

ALC4/2016 1811HQ File :01/82/050/00480/AM17/ Party Name;ALPHAMED FORMULATIONS P LTD. Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred .J Lic.No/Date:0910063771 08.06.2016 Defer Date:13.12.2017 RLA File :09/24/040/00087/AM17/ Decision : The Committee noted that infomation has been called for fro™ firm in NC reply and deferred tl^ case. , ^ 182 CaseNo.:121/10/82- ALC4/2016 HQ File :01/82/050/00467/AM17/ Party Name:OPTIMUS drugs private LIMITED Meet No/Date:5/82- ALC4/20I7 25.10.2017 StatusiDeferred Lic.No/Date:0910063765| 08.06.2016 Defer Date:13.12.2017 RLA File :09/24/040/Q0032/AM17/, Decision : The Committee noted that information has been called for fro™ the firm in NC CaseNo.:151/10/82- ALC4/2016 183 HQ File :01/82/050/00497/AM17/ Party Name:INCHEM LABORATORIES PRIVATE LIMITED Meet No/Date:5/82- ALC4/2017 25.10.2017 Lic.No/Date:09100637781 09.06.2016 StatusiiDeferred Defer Date:13.12.2017 RLA File „:09/24/040/00j23/AM17/! Decision : The Committee noted that information has been called for from the j" ^C

CaseNo.:12/10/82- ALC4/2016 184 HQ File :01/82/050/00358/AM17/ Party Name:CAPLIN POINT LABORATORIES LTD., RLA File :04/24/040/00043/AM17/j Meet No/Date: 5/82- ALC4/2017 25.10.2017 StatusiDeferred Lic.No/Date:04101620341 10.06.2016 Defer Date:13.12.2017 Inpricinn ? Deferred. . - -

^—' . ^ i 185j a CaseNo.i47/10/82- ALC4/2016 Party NameiSUNSHIELD MeetNo/Date:5/82- i ALC4/2017 StatusiDeferred' 30

CHEMICALS LTD. 25.10.2017 HQ File ;01/82/050/00393/AM17/; RLA File :03/95/040/00196/AM17/' Lic.No/Date:0310805364' 10.06.2016 1 Defer Date: 10.01.2018 Decision: Deferred. 186. CaseNo.:64/10/82- ' ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date: 5/82- ! ALC4/2017 1 25.10.2017 StatusrDeferred HQ File :01/82/050/004IO/AM17/. RLA File :31/83/040/00195/AM16/ Lic.No/Date:31100661741 13.06.2016 Defer Date: 10.01.2018 ! 1 ( 1 187, I

Case No.: 14/10/82-

! ALC4/2016 '
Party Name:CAPLIN POINT LABO^TORIES LTD., Meet No/Date:5/82- | ALC4/2017 25.10.2017 StatusiDeferredl HQ File ! :01/82/050/00360/AM17/: RLA File :04/24/040/00049/AM17/ Lic.No/Date:041016204lj 14.06.2016 j Defer Date:13.12.2017: Decision: Deferred. ; 188

Case No.:52/10/82-

ALC4/2016 Party Name:CLARIANT INDIA LIMITED Meet No/Date:5/82- ALC4/2017 25.10.2017 StatusrDeferred' HQ File :01/82/q50/00398/AM17/: RLA File :03/94/040/00223/AM17/ Lic.No/Date:0310805476. 14.06.2016 Defer Date: 10.01.2018 i Decision: Deferred. 1 1 189| CaseNo.:137/10/82- ALC4/2016 Party Name:PROCESS AGROCHEM INDUSTRIES PVT. LTD. Meet No/Date:5/82- 1 ALC4/2017 25.10.2017 [ StatusrDeferred' j 1 HQ File |01/82/050/00483/AM17/, RLA File ;56/24/040/00009/AM17/ Lic.No/Date:5610004930| 14.06.2016 1 Defer Date: 10.01.2018 ; J Decision: Deferred. CaseNo.rl9/10/82- ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:5/82- ALC4/2017 25.10.2017 Status: Approved 190 HQ File :01/82/050/00365/AM17/ ' RLA File :05/24/040/00117/AM17/ Lic.No/Date:0510398800; 14.06.2016 Defer Date: 1 Decision r The Committee decided to ratify norms based on the recommendation of D/oi Pharmaceuticals O.M.No. 35011/281/2016-PI^orms) dated 15.09.2017, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.l.RA i9i;CaseNo.:2S/10/82- ALC4/2016 Party NameiASTEC LIFESCIENCES LTD., Meet No/Date:5/82- i ALC4/2017 StatusrDeferred 31

■25.10.2017 . . . J,

.1IQ File I 01/82/050/00371/AM17/ : ILA File 11 03/94/040/00132/AM17/| 1 .ic.No/Date:0310805494,1 5.06.2016 il Defer Date:13.12.2017 Idecision : Deferred. .

^ .

. , — p i ::aseNo.:23/10/82- ;1 \LC4/2016 1 ' ] ^arty Name:RECKITT
3ENCKISER( INDIA) ^ PRIVATE LIMITED, : Vieet No/Date:5/82- |! \LC4/2017 Z5.10.2017 ! 5tatus:Deferred 192. HQ File 01/82/050/00369/AM17/ RLA File , Lic.No/Date:0510398826'; Defer 05/24/040/00128/AM17/I 16.06.2016 _ , Date:13.12.2017 ilDecision : Deferred. _ . J

1 Case No.:62/10/82- ALC4/2016 Party NameiAMI ] ORGANICSPVTLTD. j Meet No/Date:5/82- i ALC4/2017 25.10.2017 StatusiDeferred' '193 HQ File :01/82/050/00408/AM17/' RLA File :52/24/040/00019/AM17/, Lic.No/Date:521004I935i 17.06.2016 _ ) Defer Date: 10.01.2018 Decision : The Committee decided to send copy of application to DIPP (Chemicaisj ror meir comments. .

... . l| CaseNo.:57/10/82- ALC4/2016 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:5/82- ALC4/2017 25.10.2017 StatusiDeferred ,194 HQ File ;01/82/050/00403/AM17/ RLA File :05/23/040/00054/AMl 7/ Lic.No/Date:0510398839 17.06.2016 Defer Date: 10.01.2018 jDecision: Deferred,

_

; CaseNo.:58/10/82- ALC4/2016 Party NameiAMI ORGANICS PVTLTD. ' Meet No/Date:5/82- ; ALC4/2017 25.10.2017 Status:Deferred ^195 ^ HQ File :01/82/050/00404/AM17/ RLA File ■ :52/24/040/OOOl8/AM17/ .Lic.No/Date;5210041937 120.06.2016 Defer Date; , 10.01.2018 Decision : The Committee decided to send copy of application to UIPP (CHemicals; tor iheir . comments.

. . . — .. . - — _ . — CaseNo.:29/10/82- ALC4/2016 196 Party NameiAARTI INDUSTRIES LIMITED HQ File :01/82/050/00375/AM17/ RLA File :03/94/040/00208/AM17 ALC4/2017 25.10.2017 Lic.No/Date:0310805623 21.06.2016 Defer Date:13.12.2017 Decision: Deferred.

Case No.:33/16/82-

Party NameiSHREE Meet No/Date:5/82- Status:Deferred 197' ALC4/2016 JAVA ALC4/2017 LABORATORIES PVT | 25.10.2017 j LTD. 1

' 32

HQ File :01/82/050/00850/AM17/ RLA File :09/24/040/00128/AM17/ Lic.No/Date:0910063810 21.06.2016 Defer Date:13.12.2017 , - Decision: Deferred. _ _

Case No.:78/10/82-

ALC4/2016 Party Name:AMOL PHARMACEUTICALS Meet No/Date:5/82- ALC4/2017 Status:Deferred| 1 198 PVT. LTD. 25.10.2017 j HQ File :01/82/050/00424/AM17/ RLA File :13/24/040/00009/AM17/ Lic.No/Date:1310048295 22.06.2016 Defer | Date:13.12.2017^ Decision: Deferred. r . CaseNo.:105/10/82- ^ ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:5/82- ALC4/2017 Status:Deferred |l99 .. _ . 25.10.2017 1 HQ File 1 :01/82/050/00451/AM17/^ RLA File :05/24/040/00133/AM17/ Lic.No/Date:0510398872 22.06.2016 Defer Date:13.12.2017i Decision; Deferred. | 1 i Case No.:35/16/82- ALC4/2016 Party Name;SHREE ; JAVA Meet No/Date:5/82- i ALC4/2017 Status:Deferred> 200' j LABORATORIES PVT LTD. 25.10.2017 1 HQ File :01/82/050/00852/AM17/^ RLA File :09/24/040/00154/AM17/ Lic.No/Date:0910063814i 22.06.2016 Defer Date:13.I2.2017, ' Decision: Deferred.

'Case No.:83/16/82- ALC4/2016 Party Name: VIVIMED LABS LIMITED Meet No/Date:5/82- i ALC4/2017 ; Statiis:Deferred 201:' 1 25.10.2017 HQ File :01/82/050/00900/AM17/: RLA File :09/24/040/00101/AM17/, Lic.No/Date: 0910063816 22.06.2016 Defer Date: i 10.01.2018

'Decision : Deferred. ii— . < , 1 1 1 t 1 1 CaseNo.:109/10/82- ALC4/2016 Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. VIeet No/Date:5/82- 1 ALC4/2017 25.10.2017 Status:Deferred| 202,HQ File :01/82/050/00455/AM17/ RLA File 22/24/040/00022/AM17/ Lic.No/Date:2210015511) 23.06.2016 Defer Date:13.12.2017 ' ! Decision : The Committee noted that information has been called for from the firm in NC j Case No.:38/10/82- Party Name:ORBIT LIFE Meet No/Date: 5/82- Status: 203'ALC4/2016 SCIENCE PVT. LTD. ALC4/2017 Approved; 25.10.2017 33

HQ File :01/82/050/00384/AM17/ Lic.No/Date;03108057481 28.06.2016 Defer Date: of D/o RLA File :03/95/040/00234/AM17/ Decision : The Committee decided to ratify norms based on the recommendation Pharmaceuticals O.M.No. 35011/225/2016-PI(Norms) dated ™ ^ these minutes or as applied by the firm whiehever .s less under para 4.07 of HBP Vol.l.RA concerned may take necessary action ^ per decjsion of NC. iC^ase No,:39/10/82- P lLC4/2016 S 1 arty NametORBIT LIFE I ^ CIENCEPVT.LTD. / 2 /IeetNo/Date:5/82- |S ^LC4/2017 I 5.10.2017 1 tatus: )eferred 2U4jj • IQ File F 01/82/050/00385/AM17/ : tl,A File i 1 03/95/040/00235/^17/; 2 .ic.No/Date:0310805747; I .8.06.2016 I Defer Date:13.12.2017. i1)ecision: Deferred.

i
i 1 2ase No.:61/16/82- 1 \LC4/2016 I *arty NameiVIVIMED , f .ABS LIMITED , / I ^ HeetNo/Date:5/82- ,S aC4/2017 .5.10.2017 i itatus:Deferred ■205, HQ File 1 01/82/050/00878/AM17/' ^A File 09/24/040/00145/AM17/ : Jc.No/Date;0910063847l] 28.06.2016 I Defer Date: 10.01.2018 ' ' n(>pkinn : Deferred. ^ ^ ^ _

1 1 1 ' 1

Case No.:92/16/82-

' ALC4/2016 Party NameiHETERO 1 LABS LIMITED ! i MeetNo/Date:5/82- : ALC4/2017 25.10.2017 • StatusiDeferredl 1206.HQ File : :01/82/050/00909/AM17/ RLA File i :09/24/040/00l57/AM17/i Lic.No/Date;0910063 873' 30.06.2016 ^ Defer Date: 13.12.2017 1 ^

■■■

  • . —

-- 1

Case No.:56/16/82-

ALC4/2016 Party NameiPORUS ' LABORATORIES PVT LTD MeetNo/Date:5/82- ' ALC4/2017 25.10.2017 Status:Deferred| .207 HQ File :01/82/050/00873/AM17/ RLA File :09/24/040/0015^/AM 17/ Lic.No/Date:0910063877 30.06.2016 Defer Date: 10.01.2018 : ilnpiriiRion : Deferred. _ = =——;—: :— ' .

Case No.:86/10/82-

i ALC4/2016 Party NameiJUBILANT LIFE SCIENCES LIMITED Meet No/Date:5/82- ; ALC4/2017 ,25.10.2017 Status:Deferred 1 120? HQ File 1 :01/82/050/00432/AM17y ; RLA File i ;05/23/040/00l46/AM17/ |Lic.No/Date:0510398970 104.07.2016 1 Defer Date: ; 10.01.2018 ilnprisinn : Deferred.

^ ' ,

120

Case No.:101/10/82-

,ALC4/2016 91 Party Name:JUBILANT LIFE SCIENCES LIMITED 1 MeetNo/Date:5/82- ;ALC4/2017 125.10.2017 StatusiDeferred I. i HQ File ' RLA File 1 Lic.No/Date:051039897i; Defer Date: ' 34

;01/82/050/00447/AM17/ ;05/23/040/00173/AM17/'04.07.2016 10.01.2018 ! Decision: Deferred. 210 1

Case No.:5/14/82-

ALC4/2016 Party NamerASTRAL STERITECH PVT. LTD. Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred HQ File :01/82/050/00803/AM17/ RLA File :34/24/040/00099/AM17/ Lic.No/Date:3410042324 05.07.2016 Defer Date:13.12.2017 Decision: Deferred. — 1 '211

Case No.:2/16/82-

ALC4/2016 Party Name:ASTRAL STERITECH PVT. LTD. Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred HQ File :01/82/050/00819/AM17/ RLA File :34/24/040/00100/AMl 7/ Lic.No/Date:3410042325 05.07.2016 Defer Date:13.12.2017 Decision: Deferred.

_ 212

Case No.:63/16/82-

ALC4/2016 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred| HQ File ' :01/82/050/00880/AM17/, RLA File :09/24/040/00178/AM17/ Lic.No/Date:0910063 892' 06.07.2016 Defer Date: 10.01.2018 Decision: Deferred.

213,

Case No.:4/8/82-

ALC4/2016 Party Name:GOPINATH CHEM-TECHLTD., Meet No/Date:5/82- ^ ALC4/2017 25.10.2017 Status:Deferred' HQ File :01/82/050/00342/AM17/' RLA File :08/24/040/00132/AM17/ Lic.No/Date:0810138237 07.07.2016 Defer Date: 10.01.2018 Decision: Deferred. . 1 211' CaseNo.:10/14/82- ALC4/2016 Party Name.GLOBAL MEDICINES LTD, Meet No/Date:5/82- ALC4/2017. I 25.10.2017 Status:Deferred HQ File 01/82/050/00808/AM17/' ^A File 34/24/040/00101/AM17/ Lic.No/Date:3410042344' 12.07.2016 Defer Date:13.12.2017, Decision : Deferred.

Case No.:42/16/82-

ALC4/2016 Party Name:NIFTY LABS PVT LTD., Meet No/Date:5/82- ALC4/2017 25.10.2017 Status: Approved 215 HQ File :01/82/050/00859/AM17/ RLA File :09/24/040/00206/AM17/ Lic.No/Date:0910063 914 13.07.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals O.M.No. 3501 l/30/2017-PI(Norms) dated 19.09.2017, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.l.RA 35

■|r.nncemed mav take necessary action as per dedsjonof NC. 2161 CaseNo.:29/16/82- ALC4/2016 1 Party Name'.AUROBINDO PHARMA LIMITS MeetNo/Date:5/82- i ALC4/2017 i 25.10.2017 J Status:Deferredi HQ File i ;01/82/050/00846/AM17/' RLAFile :09/24/040/00180/AM17/ Lic.NoADate;0910063923| 14.07.2016 ; Defer Date:13.12.2017: 217i CaseNo.:103/16/82- ALC4/2016 Party i Name:AUROBINDO | PHARMA LMTED _ J MeetNo/Date:5/82- , ALC4/2017 i 25.10.2017. i Status-.Deferred! HQ File :01/82/050/00920/AM17/i RLA File :09/24/040/00174/AM17/; Lic.No/Date:0910063926 14.07.2016 Defer ; Date:13.12.20171 Decision: Deferred. 218

Case No.:82/10/82-

;|Party Name.DEEPAK ALC4/2016 iNOVOCHEM ■Itechnologiesltp MeetNo/Date:5/82- 1 ALC4/2017 : 25.10.2017 J Status:Deferred HQ File jRLAFile •01/82/050/00428/AM17/; :31/83/040/00041/AM17/ Lic.No/Date:3110066246| 14.07.2016 _ Defer Date: 10.01.2018 ' ' Decision: Deferred. . _ . ■ " 219

Case No.:2/13/85-

ALC3/2016 Party Name;SRIAM LABS ' PRIVATE LIMITED ; j Meet No/Date:5/82- ^ ALC4/2017 I 25.10.2017 ..J Status:Case| Added HQ File ! :01/85/050/00110/AM17/ : RLA File | :09/24/040/00181/AM17/ J Lic.No/Date:0910063922i 14.07.2016 Defer Date: Decision : Deferred. —^ ^ i 1

Case No.:43/16/82-

l|Party Name:OPTIMUS ] ALC4/2016 DRUGS PRIVATE ' Ilimited _ _ J VIeet No/Date: 5/82- j ALC4/2017 1 25.10.2017 j

——-I Status:Deferredi |220» 1 1 HQ File 'IrLAFUc j ■01/82/050/00860/AM17/' :09/24/040/00213/AM17/i Lic.No/Date:0910063938l 15.07.2016 Defer i Date:13.12.2017: Decision : Deferred. ^

— ^ 1 . ; i

Case No.:32/16/82-

ALC4/2016 Party , Mame:AUROBINDO , PHARMA LIMITED _ Meet No/Date:5/82- i ALC4/2017 25.10.2017 j Status:Deferredi ;22i 1 1 , HQ File 1 •01/82/050/00849/AM17/! RLA File :09/24/040/00218/AM_17/ Lic.No/Date:0910063947 19.07.2016 Defer Date:13.12.2^171 {Decision: Deferred. ... . .. — -•

  • -^1 222 1 Case No.:34/16/82- 1aLC4/2016 Party Name:VIVIMED LABS LIMITED Meet No/Date:5/82- iALC4/2017 StatusiDeferred ' .. 36

1 • i 1 25.10.2017 I ; 1 1 HQ File :01/82/050/00851/AM17/. RLA File :09/24/040/00199/AM17/ Lic.No/Date:a910063950! 20.07.2016 1 Defer Date: 10.01.2018 Decision: Deferred. j 1 '223' CaseNo.:27/16/82- ALC4/2016 i Party Name:BRILLIANT BIO PHARMA PRIVATE LIMITED Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred! HQ File ;0I/82/050/00844/AM17/ RLA File ;09/24/040/00132/AM17/ Lic.No/Date:0910063967' 21.07.2016 ' Defer Date:13.I2.2017 Decision: Deferred. 1 i 224 CaseNo.:3/14/82- ALC4/2016 Party Name:TRANSPEK i INDUSTRY LIMITED Meet No/Date:5/82- 1 ALC4/2017 ! 25.10.2017 J Status:Deferred! HQ File :01/82/050/00801/AM17/. RLA File :34/24/040/00124/AM17/ Lic.No/Date:3410042372i 22.07.2016 i Defer Date:I3.12.2017 Decision: Deferred. J

; 1 225, CaseNo.:60/16/82- ALC4/2016 Party Name:OPTRIX LABORATORIES PRIVATE LIMITED Meet No/Date:5/82- i ALC4/2017 25.10.2017 Status:Deferred' HQ File :01/82/050/00877/AMI7/ RLA File ;09/24/040/00235/AM17/ Lic.No/Date:0910063977 25.07.2016 i Defer Date:13.12.2017 Decision: Deferred. 226 1 1 CaseNo.:49/16/82- ALC4/2016 Party Name:ALEMBIC PHARMACEUTICALS , LTD Meet No/Date:5/82- i ALC4/2017 25.10.2017 j Status:Deferred| HQ File :01/82/050/00866/AM17/i RLA File :34/24/040/00I27/AM17/ Lic.No/Date:34I0042385! 27.07.2016 j Defer Date:I3.12.20I7 J Decision: Deferred. 227' CaseNo.:8S/16/82- ALC4/2016 Party Name:OPTRIX LABORATORIES PRIVATE LIMITED Meet No/Date;5/82- ! ALC4/2017 25.10.2017 Status:Deferred HQ File :01/82/050/00902/AM17/ RLA File :09/24/040/00234/AMI7/ Lic.No/Date:0910063995' 28.07.2016 Defer Date:13.12.2017 1 Decision : Deferred. I 228'

Case No.:2/10/82-

ALC4/2016 Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD. Meet No/Date: 5/82- ALC4/2017 25.10.2017 Status: Approved HQ File :01/82/050/00348/AM17/ RLA File :07/24/040/00I15/AM17/ Lic.No/Date:07101I0I84' 29.07.2016 . Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o 37

Pharmaceuticals O.M.No. 35011/97/2016-PI(Norms) dated July 2016, these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.l.RA ^— icase No.:31/16/82- , P .LC4/2016 1L P arty Name:OPTRIX i N ABORATORIES ^ RIVATE LIMITED j 2 leet No/Date: 5/82- |S XC4/2017 1 5.10.2017 1 tatus:Deferred 229i^ 1 IQ File F J1/82/050/00848/AM17/': XA File 1 f [)9/24/040/00236/AM17/' 2 .ic.No/Date:0910063999i E 9.07.2016 ' I )efer )ate:13.12.2017 .Inecision : Deferred. :—: —1

i( i 3aseNo.:9/14/82- I aC4/2016 ,1 I 'arty Name:ALEMBIC 1 'HARMACEUTICALS v -TO ! vleet No/Date: 5/82- , S \LC4/2017 ,

5.10.2017 J itatus:Deferred !230.j File 1 01/82/050/00807/AM17/ ^A File 34/24/040/00133/AM17/' Lic.No/Date:3410042403' 1 34.08.2016 jl Defer Date:13.12.2017' iDecision : Deferred. ^

    • -—= ' _ --

1 1 1 CaseNo.:25/16/82- ' ALC4/2016 1 Party Name:SYNTHO CHIRALS PVT. LTD 1 VIeetNo/Date:5/82- | ALC4/2017 ; 25.10.2017 1 Status:Deferred' '231,HQ File 1 :01/82/050/a0842/AM17/i RLA File i :09/24/040/00248/AM17/; Lic.No/Date;0910064009l 04.08.2016 ; Defer Date: 10.01.2018 Decision: Deferred.

j i 1 Case No.:21/16/82- ALC4/2016 Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date: 5/82- ' ALC4/2017 25.10.2017 StatusiDeferred ■;232 HQ File :01/82/050/00838/AM17/ RLA File :09/24/040/00151/AM17/ Lic.No/Date:0910064013 08.08.2016 Defer Date:13.12.2017 {Decision: Deferred. _ — —

Case No.:139/16/82-

ALC4/2016 : Party Name:ARJUN , CHEMICALS PVTLTD 1 MeetNo/Date:5/82- , ALC4/2017 ■25.10.2017 Status:Deferredi !233: HQ File , :01/82/050/00956/AM17/ ' RLA File ■ :04/24/040/00080/AM17/ ' Lic.No/Date:041016217C 08.08.2016 , Defer Date: ' 10.01.2018 1 T)P!r.isinn : Deferred. „

    • ^ 1 ii— 23' ;CaseNo.:14/16/82- ^ ALC4/2016 Party Name:DR. ;REDDYS ' LABORATORIES LIMITED 1 Meet No/Date: 5/82- :ALC4/2017 '25.10.2017 ( ; Status:Deferred< HQ File :01/82/050/00831/AM17 RLA File /' :09/24/040/00229/AM17 Lic.No/Date:091006402' /, 11.08.2016 , Defer ;Date:13.1_22017; 38

' 235 CaseNo.:22/16/82- ALC4/2016 Party Name:VIVIMED LABS LIMITED Meet No/Date:5/82- ALC4/2017 25.10.2017 ; Status:Deferred' HQ File :01/82/050/00839/AM17/ RLA File :09/24/040/002Il/AM17/ Lic.No/Date:0910064039 16.08.2016 Defer Date: 10.01.2018 1 Decision : Deferred. CaseNo.:9/16/82- ALC4/2016 Party Name:ALEMBlC PHARMACEUTICALS LTD Meet No/Date:5/82- ALC4/2017 I 25.10.2017 1 Status: Approved 236i HQ File :01/82/050/00826_/AM17/ ! RLA File ;34/24/040/00146/AM17/ j Lic.No/Date:3410042456; 19.08.2016 j Defer Date: j ! Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals O.M.No. 3501 l/36/2017-Pl(Norms) dated 17.10.2017, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.l.RA' concerned may take necessary action as per decision of NO. .

Case No.:15/16/82-

ALC4/2016 Party Name:GRANULES INDIA LIMITED Meet No/Date:5/82- 1 ALC4/2017 ' 25.10.2017 StatusiDeferred HQ File :01/82/050/00832/AM17/ RLA File :09/24/040/00264/AM17/ Lic.No/Date:09100640571 19.08.2016 Defer Date:13.12.2017 Decision: Deferred. 237 1 CaseNo.:90/n/82- ALC4/2016 Party Name:MlCRO LABS LTD Meet No/Date: 5/82- | ALC4/2017 1 25.10.2017 Status: Approved; 238; HQ File :01/82/050/00624/AM17/ I RLA File :07/24/040/00167/AM17/ I Lic.No/Date:0710110277 19.08.2016 Defer Date: 1 .
Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals O.M.N0. 3501 l/52/2015-Pl(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.l.RA 239 CaseNo.:46/16/82- ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred HQ File :01/82/050/00863/AM17/ RLA File :09/24/040/00276/AM17/ Lic.No/Date:0910064077 26.08.2016 Defer Date:13.12.2017, 240 CaseNo.:140/16/82- ALC4/2016 Party Name;NUTRA SPECIALITIES PVT. LTD., Meet No/Date:5/82- ALC4/2017 25.10.2017 StatusrDeferred HQ File :01/82/050/00957/AM17/ RLA File :04/24/040/00265/AM16/ Lic.No/Date:0410162242' 02.09.2016 Defer Date:13.12.2017 39

Decision : The Committee noted that information has been called for from the firm m NO meetingNo.02/82 dated 13.09.2017 is awaited. The Committee accordingly decided await the

1 I^ase No,:166/20/82- ALC4/2016 ^arty Name:REINE 1 LIFESCIENCE ; vleet No/Date:5/82- ALC4/2017 25.10.2017 Status'.Deferred 241, 1 HQ File :01/82/050/01343/AM17/ RLA File :34/24/040/00151/AM17/1 Lic.No/Date:3410042495 07.09.2016 Defer Date:13.12.2017, Decision: Deferred. _ CaseNo.:167/20/82- ALC4/2016 Party Name:REINE LIFESCIENCE Meet No/Date: 5/82- j ALC4/2017 ! 25.10.2017 i StatusiDeferred 2421 HQ File :01/82/050/01344/AM17/, RLA File ' ;34/24/040/00154/AM17/i Lic.No/Date:3410042496| 07.09.2016 Defer Date:13.12.2017, Decision: Deferred.

. . CaseNo.:100/16/82- ALC4/2016 Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferredi 243 HQ File :01/82/050/00917/AM17/ RLA File :05/23/040/00272/AM17/ Lic.No/Date:0510399660 08.09.2016 Defer Date:13.12.2017 Decision : Deferred. . . . ,

.. — CaseNo.:90/16/82- ALC4/2016 244 HQ File :01/82/050/00907/AM17/ Party NameiMAHIMA LIFE SCIENCES PVT.LTD. ALC4/2017 25.10.2017 Lic.No/Date:0510399749 16.09.2016 Defer Date:13.12.2017 RLAFile _:05/24/040/00229/AM17/ Decision : The Committee noted that information has been called for from the fim in NC _

1 CaseNo.:91/16/82- ALC4/2016 Party NameiMAHIMA LIFE SCIENCES PVT.LTD. , Meet No/Date:5/82- ALC4/2017 25,10.2017 Status: Approved, 245; HQ File :01/82/050/00908/AM17/ RLA File ;05/24/040/00216/AM17/ Lic.No/Date:0510399740; 16.09.2016 Defer Date: i Decision : The Committee decided to ratify norms based on the recommendation oi u/o. Pharmaceuticals O.M.No. 35011/729/2015-PI(Norms) dated 27-04.2016 uploade^t the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.l.RA'

Case No.:94/16/82-

Party NameiMAHIMA Meet No/Date:5/82- Status iDeferredi 246;ALC4/2016 LIFE SCIENCES ALC4/2017 PVT.LTD. 1 25.10.2017

40

HQ File :01/82/050/00911/AM17/^ RLA File :05/24/040/00230/AM17/, Lic.No/Date:05103997501 16.09.2016 ! Defer i Date:I3.12.20171 Decision : The Committee noted that information has been called for from the firm in NC ; j CaseNo.:95/16/82- j ALC4/2016 1 Party Name:MAHIMA ! LIFE SCIENCES i PVT.LTD. Meet No/Date:5/82-, ' ALC4/2017 i 25.10.2017 j Status:Deferred! 247 HQ File ; :01/82/050/00912/AM17/ RLA File :05/24/040/00222/AM17/' Lic.No/Date:0510399746j 16.09.2016 1 Defer i Date:13.12.2017' .j Decision : The Committee noted that information has been called for from the firm in NC j i CaseNo.:96/16/82- ALC4/2016 Party NameiMAHIMA LIFE SCIENCES PVT.LTD. MeetNo/Date:5/82- ' ALC4/2017 i 25.10.2017 I Status: Approved i 248i HQ File :01/82/050/00913/AMl 7/ RLA File :05/24/040/00223/AM17/ Lic.No/Date:0510399747' 16.09.2016 Defer Date: j } i I i Decision : The Committee decided to ratify norms based on the recommendation of D/o| Pharmaceuticals O.M.No. 3501 l/106/2015-PI(Norms) dated August 2015, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.l.RA! ! •

Case No.:97/16/82-

i ALC4/2016 1 Party Name:MAHIMA LIFE SCIENCES PVT.LTD. Meet No/Date:5/82- ' ALC4/2017 : 25.10.2017 Status:Deferredl i 249 HQ File 1 :01/82/050/00914/AM17/! RLA File :05/24/040/00261/AM17/i Lic.No/Date:0510399752 16.09.2016 Defer | Date:13.12.2017 Decision : The Committee noted that information has been called for from the firm in NC j i ; ^ 1 CaseNo.:110/16/82- ALC4/2016 1 Party Name:MAHlMA ; LIFE SCIENCES PVT.LTp. 1 Meet No/Date: 5/82- | ALC4/2017 25.10.2017- Status: Approved 1 250 HQ File :01/82/050/00927/AM17/ ' RLA File | :05/24/040/00207/AM17/ ! Lic.No/Date:0510399738l 16.09.2016 i Defer t Date: ; 1 Decision : The Committee decided to ratify norms based on the recommendation of D/oi Pharmaceuticals O.M.No. 3501 l/28/2013-PI(Norms) dated April 2015, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.l.RA, ; i i i 251: CaseNo.:119/16/82- ALC4/2016 Party Name:MAHlMA LIFE SCIENCES PVT.LTD. Meet No/Date: 5/82- ALC4/2017 25.10.2017 Status: Approvedi i HQ File RLA File Lic.No/Date:0510399742,Defer 41

Tr:01/82/050/00936/AM17/ i :05/24/040/00220/AM17/ i 16.09.2016 Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o; Pharmaceuticals O.M.No. 35011/868/2015-PI(Norms) dated 24.05.2016, uploaded at the end oft these minutes or as applied by the firm whichever is less under para 4.07 of HBP VoI.l.RAj concerned may take necessary action as per decision of NO. i 1 CaseNo.:6/20/82- ALC4/2016 1 Party NameiMAHIMA LIFE SCIENCES PVT.LTD. Meet No/Date:5/82- ALC4/2017 25.10.2017 Status: Deferred 252| r HQ File ! :01/82/050/01183/AM17/i RLA File :05/24/040/00221/AM17/ Lic.No/Date:05I0399744 16.09.2016 Defer Date:25.I0.2017' 1 1 Decision : The Committee noted that information has been called for fi*om the firm in NCi meeting No.02/82 dated 13.09.2017 is awaited. The Committee accordingly decided await thei i 253i CaseNo.:6/16/82- ALC4/2016 1 ( ( Parly NameiDIVIS LABORATORIES LTD Meet No/Date:5/82- ALC4/2017 25.10.:^17 Status:Deferred HQ File :01/82/050/00823/AM17/' RLA File j :09/24/040/00327/AM17/; Lic.No/Date:0910064153 19.09.2016 Defer | Date:13.12.2017' Decision: Deferred. i 1 I i 254 1 1 CaseNo.:99/16/82- ; ALC4/2016 1 Party NameiHPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:5/82- ALC4/20I7 25.10.2017 Status:Deferred i 1 1 HQ File :01/82/050/00916/AM17/: RLA File :05/23/040/00280/AM17/ Lic.No/Date:0510399773 20.09.2016 Defer Date: | 10.01.2018 ! ( i 1 1 ! 255 CaseNo.:70/16/82- i ALC4/2016 ' Party NamerlNDO PHYTO CHEMICALS PVTLTD Meet No/Date:5/82- ALC4/2017 25.10.2017 _ Status:Deferredi i HQ File :01/82/050/00887/AMl7/i RLA File :05/23/040/00237/AM17/ Lic.No/Date:0510399777 20.09.2016 Defer Date:13.12.2017; Decision: Deferred. 1 256

Case No.:76/16/82-

ALC4/2016 I 1 1 Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN mOH POLYMER Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred! HQ File i :01/82/050/00893/AM17/: RLA File :05/23/040/00162/AM17/ Lic.No/Date:0510399799 21.09.2016 Defer Date: 1 10.01.2018 ' Decision: Deferred. i 42

CaseNo.:168/20/82- ALC4/2016 Party NameiTATVA CHINTAN PHARMA Meet No/Date: 5/82- ALC4/20I7 Status:Deferred! 1 2571-^

CHEM PVTLTD 25.10.2017 I HQ File ;01/82/050/01345/AM17/ RLA File :34/24/040/00172/AMI7/ Lic.No/Date:3410042543 21.09.2016 Defer Date: 10.01.2018 Decision: Deferred. ^

• CaseNo.:72/16/82- ALC4/2016 Party Name:ASIATIC DRUGS &PHARMACEUTICAL Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferre d 258 i S PVT. LTD. HQ File :01/82/050/00889/AM17 I / RLA File :05/23/040/00214/AMI7/ Lic.No/Date:051039981 6 22.09.2016 Defer Date:13.12.2017l 1 1 Decision: Deferred.

  • _ .. . •

Case No.:6/14/82-

ALC4/2016 Party Name:SWATI MENTHOL & ALLIED Meet No/Date:5/82- ALC4/2017 Status:Deferred i259 j i 1 i —

. . CHEMICALS LTD., 25.10.2017 : , J HQ File ;01/82/050/00804/AM17/- RLA File :29/24/040/00002/AMI7/ Lic.No/Date:2910025262i 23.09.2016 Defer Date: 10.01.2018 ; 'Decision: Deferred. .

_ .

Case No.:93/X6/82-

ALC4/2016 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:5/82- ALC4/2017 Status:Deferredi :260|

.

1 25.10.2017 HQ File 1 :01/82/050/00910/AM17/i RLA File :05/24/040/00301/AM17/ Lic.No/Date:0510399916' 27.09.2016 Defer Date: 10.01.2018 Decision: Deferred. . 1 !261| ; ! 1

Case No.:78/16/82-

ALC4/2016 Party Name:KLJ PLASTICIZERS LIMITED Meet No/Date:5/82- 1 ALC4/2017 25.10.2017 Status:Deferred j HQ File 1 :01/82/050/00895/AM17/' RLA File :05/23/040/00304/AM17/ Lic.No/Date:0510399927, 28.09.2016 Defer Date: 10.01.2018 Decision : Deferred.

'

Case No.:109/16/82-

ALC4/2016 Party Name:PANERA BIOTEC PVT.LTD. Meet No/Date:5/82- ALC4/2017 Status:Deferred '262' .

. 25.10.2017 HQ File , 01/82/050/00926/AM17/' RLA File 05/24/040/00307/AM17/ Lic.No/Date:0510399924| 28.09.2016 J Defer Date:13.12.2017 .JDecision: Deferred. .

. 263' , 2 CaseNo.;140/20/82- 1 \LC4/2016 ] 'arty Name:SRINI PHARMACEUTICALS 2 Meet No/Date:5/82- \LC4/2017 Status:Deferred 43

PRIVATE LIMITED HQ File :01/82/050/013l7/AM17/' 25.10.2017 RLA File :09/24/040/00348/AM17/i Lic.No/Date;0910064196i 28.09.2016 i Defer Date:13.12.2017 264; Decision: Deierrea. CaseNo.:128/16/82- , ALC4/2016 Party Name:CADILA ! PHARMACEUTICALS j LTD. .. Meet No/Date:5/82-
ALC4/2017 25.10.2017 . i Status:Deferred| HQ File ;01/82/050/0094_5/AM17/ RLA File :08/24/040/0026(VAM 1 It Lic.No/Date:0810138777j 30.09.2016 Defer Date:13.12.2017; i|Decision: Deferred.

Case No.:125/l6/82-

ALC4/2016 Party Name:MAHARSHI PHARMA CHEM PVT.LTD, 265i Meet No/Date:5/82- i ALC4/2017 '25.10.2017 ^ Lic.No/Date:0810138776 30.09.2016 Status: Approved' 1 |266;

Case No.:69/16/82-

ALC4/2016 Party Name:DHANUKA | LABORATORIES LTD. | 1 Meet No/Date:5/82- ALC4/2017 25.10.2017 i Status:Deferred HQ File :01/82/050/00886/AM17/ RLA File 1 ;05/23/040/00310/j^l7/] ~ Lic.No/Date:0510399960] 03.10.2016 Defer ' Date:13.12.2017' StatustDeferred

Case No.:77/16/82-

ALC4/2016 LIFE SCIENCES LIMITED 'ho File ~ ijRLA File •ni/R9/n5O/00894/AM17/l|:05/23/040/00J8_8/AM17/ ALC4/2017 25.10.2017 Lic.No/Date:0510399958' 03.10.2016 Defer Date: 10.01.2018 Decision: Deferred.

Case No.:98/16/82-

ALC4/2016 [Party NametlNDO PHYTO CHEMICALS , PVT LTD Meet No/Date:5/82- ALC4/2017 125.10.2017 Status:Deferred 268iiho pjig iRLAFile :01/82/050/00915/AM17/ |:05/23/040/00293/AM 17/] Lic.No/Date:0510400012
04.10.2016 ' Defer Date:13.12.2017 : Decision: Deferred. 269

Case No.:164/20/82-

ALC4/2016 Party NametTIDE INDUSTRIES Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred 44

' HQ File :01/82/050/0134I/AM17/ RLA File :34/24/040/00179/AM17/ Lic.No/Date:3410042576; 04.10.2016 Defer Date: 10.01.2018 • Decision: Deferred. o CN CaseNo.:62/16/82- ALC4/2016 Party Name:PCL OIL & SOLVENTS LTD, Meet No/Date: 5/82- ' ALC4/2017 25.10.2017 ' Status:Deferred| HQ File :01/82/050/00879/AM17/' RLA File :05/24/040/00285/AM17/ Lic.No/Date:0510400053 06.10.2016 Defer Date: 10.01.2018 I Decision: Deferred. 2711 1 CaseNo.:88/16/82- ALC4/2016 Party Name;PCL OIL & SOLVENTS LTD, Meet No/Date: 5/82- 1 ALC4/2017 25.10.2017 1 Status:Deferred| HQ File :01/82/050/00905/AM17/' RLA File :05/24/040/00206/AM17/ Lic.No/Date:05104000541 06.10.2016 Defer Date: 10.01.2018 Decision: Deferred. 1 272> ( CaseNo.:116/16/82- ALC4/2016 Party Name:PCL OIL & SOLVENTS LTD, Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferredl HQ File :01/82/050/00933/AM17/ RLA File :05/24/040/00237/AM17/ Lic.No/Date:0510400057 06.10.2016 Defer Date: 10.01.2018 j 1 273 i CaseNo.:112/20/82- ALC4/2016 f Party Name:RA CHEM PHARMA LIMITED Meet No/Date:5/82- j ALC4/20I7 25.10.2017 Status:Deferred| HQ File :01/82/050/01289/AMI7/ RLA File :09/24/040/00364/AM17/ Lic.No/Date;0910064241 06.10.2016 Defer Date: 10.01.2018 274j j CaseNo.:143/16/82- ALC4/2016 Party Name:ARJUN CHEMICALS PVT LTD Meet No/Date: 5/82- | ALC4/2017 ! 25.10.2017 Status:Deferred. HQ File :01/82/050/00960/AM17/l RLA File :04/24/040/00118/AM17/ Lic.No/Date:0410162358l 07.10.2016 Defer Date: 10.01.2018 Decision: Deferred. j 1 275; CaseNo.:79/16/82- ALC4/2016 Party Name:PCL OIL& SOLVENTS LTD, Meet No/Date:5/82- ' ALC4/2017 25.10.2017 Status:Deferred| HQ File :01/82/050/00896/AM17/ RLA File ;05/24/040/00277/AM17/ Lic.No/Date:0510400073 07.10.2016 Defer Date: 10.01.2018 Decision : Deferred. 45

Case No.: 101/16/82-

(VLC4/2016 'arty Name:PCL OIL & | SOLVENTS LTD., VIeetNo/Date:5/82- 1 ^LC4/2017 ; 25.10.2017 1 5tatus:Deferred 276 HQ File :01/82/050/00918/AM17/ RLA File :05/24/040/00ll5/AM17/l l,ic.No/Date:0510400070i 07.10.2016 J Defer Date: 10.01.2018 Decision : Deferred.

Case No.:107/16/82-

ALC4/2016 Party Name:DALAS i BIOTECH LTD. 1 Meet No/Date:5/82- ' ALC4/2017 25.10.2017 ! StatusiDeferredl ;277 HQ File ;01/82/050/00924/AM17/ RLA File ;05/23/040/00474/AMl 6/! Lic.No/Date:05104001381 18.10.2016 1 Defer Date:13.12.2017 I Decision : Deferred, .

_ _ , — —

  • —

Case No.:54/16/82-

ALC4/2016 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred 278 HQ File ;01/82/050/00871/AM17/ RLA File :22/24/040/00065/AM17/ Lic.No/Date:2210015580 18.10.2016 Defer Date:13.12.2017' Decision: Deferred. j CaseNo.:108/16/82- \LC4/2016 Party Name:JUBILANT 1 LIFE SCIENCES LIMITED Meet No/Date: 5/82- ALC4/2017 25.10.2017 Status:Deferredi 2791 HQ File 01/82/050/00925/AM17/' RLA File :05/23/040/00303/AM17/ Lic.No/Date:0510400129'i 18.10.2016 ^ Defer Date: 10.01.2018 Decision ; Deferred. _ ^ _

_

1 Case No.: 130/20/82- ALC4/2016 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred ,280;HQ File :01/82/050/01307/AM17/ RLA File :09/24/040/00350/AM17/ Lic.No/Date:0910064272 19.10.2016 Defer Date:13.12.2017. Decision: Deferred.

Case No.:89/16/82-

ALC4/2016 Party Name:SlJN PHARMACEUTICAL INDUSTRIES LTD. Meet No/Date: 5/82 ALC4/2017 25.10.2017 Status: Approved 1281 HQ File ; :01/82/050/00906/AM17/ I RLA File :05/24/040/00321/AM17/ 1 Lic.No/Date:0510400153i 19.10.2016 Defer Date: 1 Decision : The Committee decided to ratify norms based on the recommendation oi uio Pharmaceuticals O.M.N0. 3501 l/52/2017-PI(Norms) dated ^5-09.2017, uploade^t t^ end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RA . concerned may take necessary action as per decision of NO. . , . 282,Case No.:26/16/82- Party Name:DEEPAK j Meet No/Date: 5/82- Status:Deferred 46

ALC4/2016 NOVOCHEM TECHNOLOGIES LTD ALC4/2017 25.10.2017 , ; HQ File :01/82/050/00843/AM17/ RLA File :3I/83/040/00055/AM17/ Lic.No/Date:3110066375 20.10.2016 Defer Date: 10.01.2018 ! ... Decision: Deferred. , —

. .. !283 1 i 1 CaseNo.:113/16/82- ALC4/2016 Party Name:KLJ PLASTICIZERS LIMITED Meet No/Date:5/82- ALC4/2017 25.10.2017 Status;Deferred! HQ File :01/82/050/00930/AM17/ RLA File :05/23/040/00346/AM17/ Lic.No/Date:0510400173 20.10.2016 Defer Date; 10.01.2018 I Decision: Deferred. '

;284

Case No.:134/20/82-

ALC4/2016 Party NameiOPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2017 25.10.2017 $tatus;Deferred' HQ File :01/82/050/01311/AM17/ RLA File ;09/24/040/00390/AM17/ Lic.No/Date:0910064282' 20.10.2016 : Defer ; Date:I3.12.2017i 1 i Decision: Deferred. I .

285

Case No.:116/20/82-

ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED MeetNo/Date:5/82- ' ALC4/2017 25.10.2017 Status:Deferred' HQ File :01/82/050/01293/AMI7/ RLA File :09/24/040/00398/AM17/ Lic.No/Date:0910064287! 21.10.2016 Defer Date:13.12.2017 Decision: Deferred.

286; CaseNo.:87/16/82- ALC4/2016 t Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred' 1 HQ File :01/82/050/00904/AM17/, RLA File :05/23/040/00287/AM17/ Lic.No/Date:0510400238] 24.10.2016 Defer Date: 10.01.2018 Decision: Deferred.

'CaseNo.:136/20/82- ALC4/2016 Party Name:VIVIMED LABS LIMITED Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred HQ File 01/82/050/01313/AM17/ ILA File 09/24/040/00370/AMI7/ Lic.No/Date:0910064291' 24.10.2016 !)efer Date: 10.01.2018 JDecision : Deferred. 288u 0aseNo.:137/20/82- 1 1LC4/2016 1 ^artyName:VIVIMED 1 .ABS LIMITED ^ 1 VIeet No/Date:5/82- ! \LC4/2017

5.10.2017 Status:Deferred 47

HQ File :01/82/050/01314/AMl7/' RLA File :09/24/040/00372/AMl 7/! Lic.No/Date:09l0064289i 24.10.2016 Defer Date: 10.01.2018 Decision : Deferred. _

=— ^ —

Case No.:69/20/82-

ALC4/2016 289, Party NametGLOBAL CALCIUM PRIVATE LIMITED, HQ File ;01/82/05_0/0_iy6/AM17/, RLA File MeetNo/Date:5/82- ! ALC4/2017 25.10.2017 Status:Deferred Lic.No/Date:07l0l 10566! 25.10.2016 .i Defer Date: 10.01.2018 jCase No.:86/16/82- IALC4/2016 Party Name:HELLO PAINTS (P) LTD 290 HQ File |:01/82/050/00903/AMl 7/ RLA File :05/23/040/a03_5yAM17/ Meet No/Date: 5/82- ALC4/2017 25.10.2017 Lic.No/Date:05104002511 25.10.2016 StatusrDeferred Defer Date: 10.01.2018 Decision: Deferred.

Case No.:51/16/82-

ALC4/2016 291 Party Name:IND-SWIFT LABORATORIES LTD., HQ File :01/82/050/00868/AM17/ Meet No/Date: 5/82- ALC4/2017 ,25.10.2017 Status:Deferred Lic.No/Date:2210015 5 831 25.10.2016 Defer Date:13.12.2017 RLA File :22/24/040/00067/AM17/j Decision : The Committee' noted that information has been called for fr"""^ ^ mee«ngNo.02/82 dated 13.09.2017 is awaited. The Committee accordingly decided await the _. i ^—

Case No.:67/16/82-

ALC4/2016 292 HQ File :0l/82/O50/00884/AMl7/ Party Name:PAYAL PETROCHEM PRIVATE LIMITED RLA File :05/24/040/0W^/AMj7/ Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred Lic.No/Date:0510400261 25.10.2016 Defer Date: 10.01.2018 Decision; Deferred. 293|

Case No.:102/16/82-

ALC4/2016 i i Party Name:PAYAL ! PETROCHEM i PRIVATE LIMITED _j Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred< HQ File :01/82/050/009l9/AMi7/' RLA File i ;05/24/040/00318/AMl7/; Lic.No/Date:0510400258, 25.10.2016 Defer Date: 10.01.2018 294'i 1 1

Case No.:125/20/82-

ALC4/2016 Party Name:ARENE ! LIFE SCIENCES | LIMITED. . _j Meet No/Date: 5/82- ALC4/2017 25.10.2017 _ 1 Status:Deferred, HQ File :01/82/050/01302/AMl7/' RLA File ;09/24/040/00318/AM17/J Lic.No/Date:0910064309' 26.10.2016 Defer Date:13.12.2017: 48

Decision: Deferred. 1 j 295 CaseNo.:131/20/82- ALC4/2016 Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred| 1 1 HQ File :01/82/050/01308/AM17/ RLAFile :09/24/040/00319/AM17/ Lic.No/Date:0910064308 26.10.2016 Defer Date:13.I2.2017' • Decision: Deferred. .. |296 j , CaseNo.:133/20/82- ALC4/2016 Party Name: ARENE LIFE SCIENCES LIMITED. Meet No/Date: 5/82- ALC4/2017 25.10.2017 Status:Deferred! HQ File :01/82/050/01310/AM17/ RLAFile :09/24/040/00320/AM17/ Lic.No/Date:0910064310 26.10.2016 Defer ; Date:13.12.20171 1 .... Decision: Deferred. .

. i 1 i j

97 CaseNo.:152/20/82- ALC4/2016 Party NameiBIOLOGICAL E LTD Meet No/Date;5/82- j ALC4/2017 i 25.10.2017 Status:Deferred| HQ File :01/82/050/01329/AM]7/| RLA File :09/24/040/00220/AM17/ Lic.No/Date;0910064300! 26.10.2016 ; Defer Date:13.12.2017i 1 Decision : Deferred.

|298i ' I 1 CaseNo.:122/16/82- i ALC4/2016 i 1 Party NameiCADILA HEALTHCARE LTD Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred| * HQ File j :01/82/050/00939/AMI7/l RLA File :08/24/040/00289/AMl 7/' Lic.No/Date:0810138976 26.10.2016 i Defer Date:I3.12.2017! ; Decision: Deferred. _ i 1 , '. 299'

Case No.:126/20/82-

ALC4/2016 1 Party ; Name: EMMENN AR PHARMA PRIVATE LIMITED Meet No/Date:5/82- I ALC4/2017 ' 25.10.2017 ; 1 Status:Deferred! j 1 i : 1 HQ File :01/82/050/01303/AM17/! RLA File :09/24/040/00376/AM17/, Lic.No/Date:09100643 lli 26.10.2016 i Defer ! Date:13.12.2017: „ 30oj CaseNo.:115/16/82- ALC4/2016 Party Name:KLJ PLASTICIZERS LIMITED Meet No/Date:5/82- j ALC4/2017 25.10.2017 ! Status:Deferred! HQ File 01/82/050/00932/AMI7/, ^A File 05/23/040/00329/AM17/ Lic.No/Date;0510400281 26.10.2016 ' Defer Date: 10.01.20187 [)ecision: Deferred. .. _

301i CaseNo.:19/16/82- ^arty NameiDHANUKA Vleet No/Date:5/82- !$tatus:Deferredi 49

ALC4/2016 LABORATORIES LTD. j 1 ALC4/2017 ' 25.10.2017 HQ File :01/82/050/00836/AM17/: RLA File | ;05/23/040/00355/AM17/l Lic.No/Date:0510400295j 27.10.2016 J Defer Date:13.12.2017, 302!

Case No.:130/16/82-

ALC4/2016 ; 1 Party NameilOL 1 CHEMICALS AND PHARMACEUTICALS LIMITED Meet No/Date:5/82- j ALC4/2017 1 25.10.2017 i j StatusiDeferredl HQ File :01/82/050/00947/AM17/ RLA File :30/24/040/00027/AM17/ Lic.No/Date;3010103875 27.10.2016 Defer Date:13.12.2017i

Case No.:165/20/82-

ALC4/2016 303 Party NametSURNI LABS HQ File :01/82/050/01342/AM17/ RLA File Meet No/Date:5/82- ALC4/2017 25.10.2017 , StatusiDeferredi Lic.No/Date:3410042630l 27.10.2016 .. . . J Defer Date:13.12.2q^nj Decision: Deferred. 1 » i

Case No.:14/14/82-

^ ALC4/2016 1 Party Name:CONCORD | BIOTECH LTD i [ Meet No/Date:5/82- ALC4/2017 25.10.2017 1 Status: Approved' 1 t 304 ; 1 HQ File 1 •01/82/050/00812/AM17/ RLA File 1 :08/24/040/00264/AM17/ ^ j Lic.No/Date:0810138999j 28.10.2016 Defer Date: ^ I!». -r p., pr v.,,,.ra. concerned may take necessary action as per decision otNL. _ ^ 3051

Case No.:66/16/82-

ALC4/2016 Party Name:PCL OIL & j SOLVENTS LTD., MeetNo/Date:5/82- ! ALC4/2017 25.10.2017 Status:Deferredl HQ File :01/82/050/008_83/AM17/! RLA File :05/24/040/003_39/AM17/ Lic.No/Date: 05104003 05! 28.10.2016 i Defer Date: 10.01.2018

Case No.:ll/16/82-

ALC4/2016 3061HQ File :01/82/050/00828/AM17/ Party Name:EMCURE PHARMACEUTICALS LTD. . . . j RLA File :31/83/040/00094/AMl 7/ Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred Lic.No/Date:3110066388 31.10.2016 Defer Date:l3.12.2017 Decision: Deferred. -in7i|ra.. Nn.;18/t6/82- "l^rty Name:HONOUR Meet No/Date;5/82- StatusrDeferred 50

ALC4/2016 LAB LIMITED ALC4/2017 25.10.2017 HQ File :01/82/050/00835/AM17/ RLA File :09/24/040/00417/AM17/ Lic.No/Date:0910064330 31.10.2016 Defer Date:13.I2.20I7 ( Decision: Deferred. 1 1 308 ' 1

Case No.:15/14/82-

ALC4/2016 Party Name:MICRO LABS LTD Meet No/Date:5/82- ALC4/2017 25.10.2017 StatusrDeferredj HQ File :01/82/050/00813/AM17/ RLA File :07/24/040/00255/AM17/ Lic.No/Date:0710110609 02.11.2016 Defer Date:13.12.20I7i Decision: Deferred. I ] 309 1

Case No.: 158/20/82-

ALC4/2016 Party Name:ENAL DRUGSPVTLTD, Meet No/Date: 5/82- 1 ALC4/2017 1 25.10.2017 StatusrDeferred' HQ File :01/82/050/01335/AM17/ RLA File :09/24/040/004Il/AM17/ Lic.No/Date:0910064347' 03.11.2016 I Defer Date:13.I2.2017 310i CaseNo.:150/20/82- j ALC4/2016 Party NameiEYTAN LABS LIMITED Meet No/Date:5/82- ' ALC4/2017 25.10.2017 Status:Deferred| HQ File :01/82/050/qi327/AMI7/| RLA File :09/24/040/00410/AM17/ Lic.No/Date:09I0064338; 03.11.2016 Defer Date:13.12.2017 t Decision: Deferred. i ! i 31l' t ! CaseNo.:157/20/82- ! ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date:5/82- 1 ALC4/2017 25.10.2017 Status:Deferred HQ File :01/82/050/01334/AM17/i RLA File :09/24/040/00426/AMI7/' Lic.No/Date:0910064346 03.11.2016 ; Defer Date:13.12.2017' Decision: Deferred. ^ . _ 3ii 1 1 CaseNo.:148/20/82- ALC4/2016 Party Name;LEE PHARMA LIMITED Meet No/Date: 5/82- 1 ALC4/2017 25.10.2017 Status:Deferred. HQ File :0I/82/050/01325/AM17/, RLA File :09/24/040/00399/AM17/ j Lic.No/Date:0910064340! 03.11.2016 J Defer Date:I3.12.2017 -. 313'

Case No.:160/20/82-

ALC4/2016 Party Name:VIRUPAKSHA ORGANICS LIMITED Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred HQ File :01/82/050/0I337/AM17/ RLA File :09/24/040/00427/AM17/ Lic.No/Date:0910064336. 03.11.2016 Defer Date:13.12.2017, 51

_

_ -■< _

—

Case No.:25/20/82-

ALC4/2016 Party Name:ALKALOIDS CORPORATION Meet No/Date:5/82- ALC4/2017 25.10.2017 ' Status:Deferred' 314' i HQ File :01/82/050/01202/AM17/' RLA File i ;02/24/040/00145/AM17/' Lic.No/Date:0210207123j 07.11.2016 Defer Date:13.12.20n

.

--

i 1 ! CaseNo.:149/20/82- ALC4/2016 1 1 Party Name:ORCH p LABORATORIES INDIA . PVTLTD _ Meet No/Date:5/82- ALC4/2017 25.10.2017 _ _ ' Status: Approved , 315 HQ File i :01/82/050/01326/AM17/ RLA File ! :09/24/040/00423/AMl 7/ Lie.No/Date: 09100643 531 07.11.2016 ! Defer Date: 1 Decision : The Committee decided to ratify norms based on the recommendation ol Uyo; Phaimaceuticals O.M.No. 3501 l/737/2015-PI(Norms) dated June uploade^t the end^ these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RA, _ . - 1( L 1 [:aseNo.:58/20/82- il \LC4/2016 , C *arty Name:ARJUN ' 1 :hemicalspvtltd

  • . vIeetNo/Date:5/82- \LC4/20I7

5.10.2017 . i;tatus:Deferred; 316' ^Q File I 01/82/050/01235/AM17/ H^AFile j 04/24/040/00140/AM17/ Lic.No/Date:0410162476. 1 38.11.2016 1 Defer Date: , 10.01.2018 ■ jlDeclsion : Deferred. . . .

= ' . — — 1I 1 •317i

Case No.: 147/20/82-

' ALC4/2016 Party Name:VIVIMED LABS LIMITED VIeetNo/Date:5/82- ! ALC4/20I7 25.10.2017 1 Status:Deferred| HQ File :01/82/050/01324/AM17/i RLA File | :09/24/040/0043 8/AM17/; Lic.No/Date:09100643 61 i 08.11.2016 Defer Date; 10.01.2018 : 1 Decision : Deferred. —1 . .

,318

Case No.:16/14/82-

i ALC4/2016 Party Name:MALLADI ' DRUGS & PHARMACEUTICALS LIMITED Meet No/Date: 5/82- : ALC4/2017 25.10.2017 Status:Deferred HQ File :01/82/050/00814/AM17/ RLA File :04/24/040/00133/AM17/ Lic.No/Date:04I0162482 10.11.2016 Defer Date:13.I2.2017 IDecision : Deferred. . . _ —

      • -——' '"'—'

— '3\S

Case No.:65/16/82-

ALC4/2016 : Party NameiDEEPAK NOVOCHEM TECHNOLOGIES LTD ; MeetNo/Date:5/82- j ALC4/2017 ',25.10.2017 Status:Deferred HQ File • :01/82/050/00882/AM17/ RLA File :31/83/040/00106/AM17/ 1 Lic.No/Date:3110066397 115.11.2016 ; Defer Date: 10.01.2018 52

Decision: Deferred. I Case No.; 144/20/82- ALC4/2016 Party Name:MYLAN LABORATORIES Meet No/Date:5/82- ALC4/2017 Status:Deferred 320 j

— -

  • -J LMTED 25.10.2017 HQ File :y/82/050/0J32iyAM17/ RLA File :09/24/040/00430/AMI7/ Lic.No/Date:0910064386 15.11.2016 Defer Date:13.12.2017 ' Decision: Deferred. i _ , 1 CaseNo.:120/20/82- ALC4/2016 Party Name:RAKSHIT PHARMACEUTICALS Meet No/Date: 5/82- ALC4/2017 Status:Deferredi !321 i LTD 25.10.2017 1 HQ File :01/82/050/01297/AM17/ RLA File :09/24/040/0042I/AM17/ Lie.No/Date:0910064379 15.11.2016 Defer | Date:13.12.2017! 1 Decision: Deferred. _

_ CaseNo.:124/20/82- i ALC4/2016 j Party Name:SUVEN LIFE SCIENCES Meet No/Date;5/82- ; ALC4/2017 ; Status :Defer red j j 322: i j 1 1 _ ^ ^1 LIMITED 25.10.2017 1 j HQ File :01/82/050/01301/AM17/l RLA File ;q9/24/040/00432/AMl 7/ Lic.No/Date:0910064382! 15.11.2016 Defer ' Date:13.12.2017 Decision: Deferred.

  • —

. CaseNo.:109/20/82- ALC4/2016 Party Name:AKTINOS HEALTHCARE Meet No/Date: 5/82- ! ALC4/2017 Status:Deferred| 323' j _ _ t PRIVATE LIMITED 25.10.2017 • HQ File ; :01/82/050/01286/AM17/. RLA File :09/24/040/00445/AM 17/ I Lic.No/Date:0910064399| 18.11.2016 ' Defer ; Date:13.12.2017: _ j ! CaseNo.:127/20/82- ! ALC4/2016 Party Name:AKTINOS , PHARMAPVTLTD, ' Meet No/Date:5/82- 1 ALC4/2017 1 Status:Deferred! 3241 i f ' 25.10.2017 i 1 HQ File :0I/82/050/0I304/AM17/| RLA File :09/24/040/00459/AM17/, Lic.No/Date:0910064397 18.11.2016 j Defer Date:13.12.2017' t — -J Decision: Deferred. .

. CaseNo.:12/20/82- j ALC4/2016 1 Party Mame:AUROBINDO VIeet No/Date:5/82- i ALC4/2017 StatusrDeferred 325! 1 1 PHARMA LIMITED 25.10.2017 HQ File 01/82/050/01189/AM17/I RLA File 09/24/040/004I9/AMI7/ Lic.No/Date:09100644071 18.11.2016 ; Defer ^ Date:13.12.2017' Decision : Deferred.

326! 1 CaseNo.:121/20/82- i ALC4/2016 i'arty Name:HETERO LABS LIMITED VIeet No/Date;5/82- i ALC4/2017 $tatus:Deferredi 53

. _ .

  • — —

' 1 25.10.2017 I — HQ File j •01/82/050/01298/AM17/i RLA File :09/24/040/00461/AM17/, Lic.No/Date:091006440I 18.11.2016 Defer Date:13.12^017; I Decision: Deferred. -■ — - —

  • —

--

Case No.: 122/20/82-

i ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date:5/82- ALC4/20I7 25.10.2017 , StatusrDeferred; '|327 HQ File ;01/82/050/01299/AM17/ RLA File :09/24/040/00451/AM17/ Lic.No/Date:0910064402 18.11.2016 Defer ! Date:13.12.2017! Decision: Deferred. . _ - J 328

Case No.: 128/20/82-

ALC4/2016 Party Name:HETERO ijlVIeet No/Date;5/82- j LABS LIMITED 1ALC4/2017 j i|25.10.2017 ! Status:Deferredl HQ File t •.01/82/050/01305/AMn/^ RLA File :09/24/040/00436/AM17/J Lic.No/Date:0910064400 18.11.2016 Defer Date:13.lZ20nj

Case No.:107/20/82-

ALC4/2016 Party Name:SALlCYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date: 5/82- ALC4/2017 25.10.2017 Status:Deferred! f : 1 HQ File ' :01/82/050/01284/AM17/ RLA File :09/24/040/00444/AM_17/ Lic.No/Date:0910064415 24.11.2016 Defer Date: 10.01.2018 1 329 Decision: Deferred. i 1 330j

Case No.:110/20/82-

ALC4/2016 1 1 1 ^arty ^^ameiSALICYLATES & CHEMICALS PRIVATE LIMITED ^ vIeetNo/Date:5/82- |! ALC4/2017 j 25.10.2017 ! 1 I 3tatus:Deferred| HQ File ' •01/82/050/01287/AM17/I RLA File :09/24/040/00443/^n/ Lic.No/Date:09100644I4! 24.11.2016 _ _ _ J Defer Date: 10.01.2018 ... JDecision: Deferred. ,

.

f jCase No.:123/20/82- | ALC4/2016 1 1 • Party NameiVlVlMED LABS LIMITED • . J MeetNo/Date:5/82- | ALC4/2017 ' 25.10.2017 Status:Deferred; [331|HQ File i:01/82/05 0/013 00/AM17/ RLA File :09/24/040/00455/AM17/ Lic.No/Date:0910064417' 28.11.2016 Defer Date: 10.01.2018 1 i|Decision:

—^ - ^ 1 ^ 332|

Case No.:36/20/82-

ALC4/2016 Party Naine:SENTISS PHARMAPVT.LTD. Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferredi 1 1 HO File ■ RLA File Lic.No/Date:0510400571, Defer 54

I:01/82/050/01213/AM17/':05/24/040/00423/AM17/ 01.12.2016 Date:I3.12.2017| '333

Case No.:106/20/82-

ALC4/2016 Party Name: PARAMOUNT AROMACHEM PVT.LTD., Meet No/Date: 5/82- ALC4/20I7 25.10.2017 Status:Deferred' 1 1 ! HQ File ;01/82/050/01283/AM17/ RLA File ;05/24/040/00399/AM17/ Lic.No/Date:0510400599 02.12.2016 Defer Date: 10.01.2018 j Decision : Deferred. .

. 334

Case No.:139/20/82-

ALC4/2016 Party Name:TAGOOR CHEMICALS Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred; 1 HQ File :01/82/050/01316/AM17/ RLA File :09/24/040/00474/AM17/ Lic.No/Date:0910064436 02.12.2016 1 Defer Date: | 10.01.2018 ' Decision: Deferred. .. I 335

Case No.:142/20/82-

ALC4/2016 Party Name:HINDYS LAB PVT LTD Meet No/Date:5/82- i ALC4/2017 25.10.2017 StatusiDeferred! HQ File :01/82/050/01319/AM17/ RLA File :09/24/040/00492/AM17/ Lic.No/Date:0910064449 07.12.2016 Defer Date:13.12.2017' • Decision: Deferred. 1 ^336'

Case No.:21/20/82-

! ALC4/2016 i Party NameJUBILANT GENERICS LTD Meet No/Date:5/82- ' ALC4/2017 25.10.2017 Status:Deferred| HQ File :01/82/050/01198/AM17/ RLA File :05/23/040/00402/AM17/ Lic.No/Date:05104006851 08.12.2016 ! j Defer i Date:I3.12.20171 ' — _j Decision: Deferred.

.. . ! i i 1 ( 337 i i

Case No.:22/20/82-

ALC4/2016 Party Name.JUBILANT ' GENERICS LTD Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred HQ File :01/82/050/01199/AM17/ RLA File :05/23/040/00404/AMI7/ Lic.No/Date:0510400686; 08.12.2016 Defer Date:13.12.2017 J Decision: Deferred. 1 ! 1

Case No.:49/20/82-

1 ALC4/2016 i'arty Name:PCL OIL & SOLVENTS LTD., Meet No/Date:5/82- ALC4/20I7 25.10.2017 Status:Deferredi ( HQ File 01/82/050/01226/AM17/ RLA File 05/24/040/00401/AM17/ Lic.No/Date:0510400682! 08.12.2016 Defer Date: 10.01.2018 Decision: Deferred. 55

Case No.:50/20/82-

ALC4/2016 Party Name:PCL OIL & SOLVENTS LTD.. IrLA File Meet No/Date: 5/82- j ALC4/2017 , 25.10.2017 StatusrDeferred Lic.No/Date:05104006811 08.12.2016 Defer Date: 10.01.2018 3401

Case No.:46/20/82-

ALC4/2016 Party NameiDIVIS j laboratories LTD - Meet No/Date:5/82- ALC4/2017 25.10.2017 . I Status:Deferredi HQ File :01/82/050/01223/i^l7/; RLA File | :09/24/040/00469/AM17/1 Lic.No/Date;0910064468] 09.12.2016 _ 1 Defer Date:13.12.20ir 341 CaseNo.:37/20/82- ALC4/2016 Party Name;IOL CHEMICALS AND PHARMACEUTICALS LIMITED _ i MeetNo/Date:5/82- i ALC4/2017 i 25.10.2017 StatusrDeferred HQ File :01/82/050/0121_4/^17/' RLA File :30/24/040/00026/AM17/ Lic.No/Date:3010103898| 09.12.2016 Defer Date:13.12.2017; 342 CaseNo.:118/20/82- |PartyName:SUVEN ALC4/2016 SCIENCES 1 |limited 1 Meet No/Date:5/82- ! ALC4/2017 , 25.10.2017 i StatusrDeferred HO File iRLAFile | •O1/82/050/01295/AM17/ :09/24/040/00472/AM17/_ Lic.No/Date:0910064464 09.12.2016 Defer Date;13.12.2017i ! reply and deferred the case. ' 343

Case No.:7/20/82-

Party Name:BIO TECH , ALC4/2016 'joPHTHALMICS PVT 1 ■ILTD . . i Meet No/Date:5/82- ALC4/2017 i 25.10.2017 StatusrDeferred HO File IrLA File j •01/82/050/01184/AM17/ l:08/24/040/0034_8/AM17/' Lic.No/Date:0810139274| 13.12.2016 Defer Date:13.12.2017

Case No.:9/20/82-

ALC4/2016 Party Name:BIO TECH OPHTHALMICS PVT LTD Meet No/Date; 5/82- ALC4/2017 25.10.2017 344 HQ File :01/82/050/01186/AM17/, RLA File :08/24/040/00355/AM17/j Status:Deferred Lic.No/Date:0810139275i 13.12.2016 Defer Date:13.12.2017 Decision: Deferred. StatustDeferred Meet No/Date: 5/82- Party NameiBIO TECH i 345 Case No.:10/20/82- 56

ALC4/2016 OPHTHALMICS PVT LTD ALC4/2017 25.10.2017

HQ File :01/82/050/01187/AM17/ RLA File :08/24/040/00353/AM17/ Lic.No/Date:0810139276 13.12.2016 Defer i Date:13.12.2017 1 Decision: Deferred. r- - CaseNo.:ll/20/82- ALC4/2016 ^ Party Name:BIO TECH OPHTHALMICS PVT Meet No/Date:5/82- ALC4/2017 StatusiDeferred' 346 _ _ LTD 25.10.2017 HQ File :01/82/050/01188/AM17/ RLA File :08/24/040/00372/AM17/ Lic.No/Date:0810139271 13,12.2016 Defer Date:I3.12.2017; ' Decision: Deferred. ' CaseNo.:17/20/82- ALC4/2016 Party Name;BIO TECH OPHTHALMICS PVT Meet No/Date:5/82- ALC4/2017 Status:Deferred, 347 _ LTD 25.10.2017 HQ File :01/82/050/01194/AM17/ RLA File :08/24/040/00371/AM17/ Lic.No/Date:0810139270^ 13.12.2016 ; Defer Date:13.12.2017: Decision: Deferred.

j CaseNo.;20/20/82- ALC4/2016 Party NamerBIO TECH OPHTHALMICS PVT Meet No/Date:5/82- ALC4/2017 Status:Deferred 348' LTD 25.10.2017 HQ File :01/82/050/01197/AM17/, RLA File :08/24/040/00362/AM17/ Lic.No/Date:0810I39257. 13.12.2016 Defer Date:13.12.2017i .J Decision: Deferred. ,

. .

Case No.:26/20/82-

ALC4/2016 Party Name:BIO TECH OPHTHALMICS PVT Meet No/Date: 5/82- ALC4/2017 Status:Deferredi 349. .

. LTD 25.10.2017 HQ File :01/82/050/01203/AM17/ RLA File ;08/24/040/00364/AM17/ Lic.No/Date:0810139259 13.12.2016 Defer Date:13.12.2017 'Decision: Deferred. _

Case No.:27/20/82-

ALC4/2016 Party Name:BIO TECH OPHTHALMICS PVT Meet No/Date;5/82- ALC4/2017 Status:Deferred 350i LTD 25.10.2017 HQ File :0I/82/050/01204/AM17/! RLA File •08/24/040/00365/AM17/ Lic.No/Date:0810139260, 13.12.2016 : Defer Date:I3.12.2017: Decision: Deferred. —

'Case No.:28/20/82- ALC4/2016 Party NamerBIO TECH OPHTHALMICS PVT Meet No/Date:5/82- ALC4/2017 Status:Deferred 351 LTD 25.10.2017 HQ File 01/82/050/01205/AM17/ RLA File 08/24/040/00363/AM17/ Lic.No/Date:0810139258: 13.12.2016 Defer Date:13.12.2017 57

_

; ,c A aseNo.:8/20/82- P JLC4/2016 C arty Nanie:GOPINATH! N HEM-TECH LTD., ' A 2 leetNo/Date:5/82- iS lLC4/2017 5.10.2017 tatus:Deferred 352! jIQFile F 01/82/050/01185/AM17/ : J_,A File ' 1- 08/24/040/00357/AM17/' 1 .ic.No/Date:0810139268| I 3.12.2016 1 1 )efer Date: 0.01.2018 Tipricion: Deferred. . '

! !* 1 f i 1

Case No.:16/20/82-

, 1 \LC4/2016 < ^arty Name:GOPINATH 11 CHEM-TECHLTD., Vieet No/Date:5/82- S \LC4/2017 Z5.10.2017 $tatus:Deferred i HQ File 01/82/050/01193/AM17/ RLA File j 08/24/040/00358/AM17/| Lic.No/Date:08101392691 13.12.2016 Defer Date: 10.01.2018 ij Decision: Deferred,

^

—

1 1 ;

Case No.:145/20/82-

ALC4/2016 Party Name:INDIAN immunologicals : LTD., ^ _ 1 Meet No/Date:5/82-
ALC4/2017 25.10.2017 Status:Deferred 354! ' HQ File :01/82/050/01322/AM17/ RLA File :09/24/040/00475/AM 17/ Lic.No/Date:0910064483 j 14.12.2016 1 Defer Date:13.12.2017;

i CaseNo.:18/20/82- ALC4/2016 Party Name: SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date;5/82- ALC4/2017 25.10.2017 Status:Deferredi ;355 1 HQ File ,:0I/82/050/01195/AM17/ RLA File i :05/24/040/00429/AM17/ ' Lic.No/Date:0510400788 1 14.12.2016 1 Defer .Date:13.12.2017 ' I :

j

Case No.:42/20/82-

|ALC4/2016 Party Name:SUN PHARMACEUTICAL I INDUSTRIES LTD., 1 Meet No/Date:5/82- :ALC4/2017 ',25.10.2017 Status:Deferred 1 .35'1 HQ File ,:01/82/050/01219/AM17 RLA File f :05/24/040/00445/AM17 Lic.No/Date:051040078' /' 14.12.2016 } Defer Date:13.12.2017 jDecision : Deferred.

Case No.:162/20/82-

ALC4/2016 357 HQ File :01/82/050/01339/AM17/ Party Name:ESTEEM INDUSTRIES PRIVATE; LIMITED ' RLA File i :17/24/040/00148/AM17/ Meet No/Date: 5/82- ALC4/2017 25.10.2017 Lic.No/Date:1710006508i 15.12.2016 Status:Deferred Defer Date: 10.01.2018 , _ 'Decision: Deferred.

^ 358^ CaseNo.:19/20/82- ALC4/2016 1 Party Name:JUBILANT , GENERICS LTD 1 Meet No/Date: 5/82- ALC4/2017 ! Status: Approved 1 58

1 25.10.2017 ; ) : HQ File :01/82/050/OI196/AMI7/ RLA File :05/23/040/00435/AM 17/ Lic.No/Date:0510400809 15.12.2016 Defer Date: i 1 ' decision : Ihe Committee decided to ratify norms based on SIGN A-4I2 or as applied by the i firm whichever is less under para 4.07 of HBP Vol. 1 .RA concerned may take necessary action as i per decision of NC. 1 — - i 13591 ' 1 1

Case No.:34/20/82-

ALC4/2016 Party NamerSTERLING AUXILIARIES PVT LTD Meet No/Date:5/82- ALC4/20I7 25.10.2017 Status:Deferred| HQ File :OI/82/050/01211/AM17/ RLA File :03/95/040/00702/AM17/ Lic.No/Date:0310809914 15.12.2016 Defer Date: 10.01.2018 360,

Case No.:43/20/82-

ALC4/2016 Party Name:ESTEEM INDUSTRIES PRIVATE LIMITED Meet No/Date:5/82- ALC4/20I7 25.10.2017 Status:Deferred, HQ File :01/82/050/01220/AM17/' RLA File : 17/24/040/00149/AM17/ Lic.No/Date: 1710006509i 16.12.2016 i Defer Date: 10.01.2018 t Decision; Deferred. 1 1 361,

Case No.:41/20/82-

ALC4/2016 Party Name:HONEST BIO-VET PVT. LTD Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred' HQ File :01/82/050/0I218/AM17/ RLA File :08/24/040/00383/AMl 7/ Lic.No/Date:0810139328 19.12.2016 Defer Date:13.12.2017 Decision: Deferred. 362

Case No.:44/20/82-

ALC4/2016 Party Name:HONEST BIO-VET PVT. LTD Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred' HQ File :01/82/050/0122I/AM17/i RLA File :08/24/040/00382/AM17/ Lic.No/Date:0810139327' 19.12.2016 Defer Date:13.12.2017i Decision: Deferred. 363

Case No.:53/20/82-

ALC4/2016 Party Name:TORIN ORGANICS PVT LTD MeetNo/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred! HQ File :01/82/050/01230/AM17/' RLA File :35/24/040/0001I/AM17/ Lic.No/Date:3510045081' 21.12.2016 Defer Date:13.12.2017' Decision: Deferred. 364

Case No.:14/20/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:5/82- ALC4/2017 25.10.2017 Status: Approved HQ File RLA File Lic.No/Date:0810139354 Defer 59

',[roi/82/050/01191/AM17/ _ j:08/24/040ffl03j6/AM17/ ^2.1220^ ^ : "7 ' t. j.j TZ nnrmc liased Of! thc T Date: Ph—icals O.M.NO. 350. 4m2.«is .ess unde. p.a 4.07 of HBP Vo....RA "

. . oc rtpr Hftr;i5inn or NC.

these minutes or as appiieu vy i"'" —-y, concerned may take necessary action as per decision offl I StatusiDeferred Meet No/Date:5/82- Party Name;CADILA HEALTHCARE LTD ALC4/2017 25.10.2017 , Case No.:54/20/82- ALC4/2016 Lic.No/Date:081013935i; 22.12.2016 Defer Date:13.12.2017 RLA File HQ File rxv * :08/24/040/00320/^17/ :01/82/050/01231_/AM17/, llDecision: Deferred. StatusiDeferred Case No,:51/20/82- ALC4/2016 Jparty Name:V.D.H. ORGANICS PVT. LTD I 366| Tjo File i RLA File :01/82/050/01228/AM17/ :05/24/040/Q046^AM17/l {Decision: Deferred. Meet No/Date:5/82- ALC4/2017 25.10.2017 j Lic.No/Date;05104009211 23.12.2016 • Defer Date: 10.01.2018 ,367 CaseNo.i45/20/82- ALC4/2016 Party Name:S.M. | HERBALS PVT.LTD. i j Meet No/Date:5/82- ALC4/2017 25.10.2017 . StatusiDeferred; HQ File ; ;01/82/050/01222/AM17/ RLA File i :05/24/040/00470/AM17/ Lic.No/Date:0510400935 26.12.2016 Defer Date: 10.01.2018 Decision: Deferred, StatusiDeferred Meet No/Date:5/82- Party Name:SAPTAGIR CAMPHOR LIMITED

Case No.ill7/20/82-

ALC4/2016 ALC4/2017 25.10.2017 Defer Date: Lic.No/Date:0910064520j RLA File :0?/82/050/01294/AM17/' :09/24/040/0051lA^17/j ; 10.01.2018 26.12.2016 Decision i Deferred. StatusiDeferred

Case No.i56/20/82-

ALC4/2016 Party Name:BIO TECH OPHTHALMICS PVT LTD Meet No/Date:5/82- ALC4/2017 25.10.2017 Lic.No/Date:08l0139382, 27.12.2016 Defer 369 RLA File Date:13.12.2017 !o?/82/050/01233/AM17/ !M/24/040/004qi/AM17/ Decision i Deferred. StatusiDeferred CaseNo.i73/20/82- ALC4/2016 ' Party Name:S M CHEMICAL VAPI , PRIVATE LtMITEP Meet No/Date:5/82- ALC4/2017 25.10.2017 Lic.No/Date:03108101401 28.12.2016

Decision: Deferred. 1 371;

Case No.:2/20/82-

ALC4/2016 1 ^ ^ J Party Name:SHREE BANKEY BEHARILAL AROMATICS Meet No/Date:5/82- ALC4/2017 25.10.2017 i Status:Deferred! 1 HQ File ; :01/82/050/01179/AM17/ RLA File :05/24/040/00471/AM17/' Lic.No/Date:0510400977; 28.12.2016 Defer Date: 1 10.01.2018 Decision: Deferred. i ,372

Case No.:47/20/82-

ALC4/2016 Party NameiBALAJI AMINES LIMITED Meet No/Date:5/82- ALC4/20I7 25.10.2017 Status:Deferred

  • .. HQ File :01/82/050/01224/AM17/ RLA File :31/83/040/00087/AM17/ Lic.No/Date:3110066522 29.12.2016 Defer Date: 10.01.2018
  • Decision: Deferred. — _ ] :373 1

Case No.:48/20/82-

ALC4/2016 Party Name:BALAJI AMINES LIMITED Meet No/Date: 5/82- ALC4/2017 25.10.2017 Status:Deferred' 1 HQ File :01/82/050/01225/AM17/ RLA File :3I/83/040/00089/AM17/ Lic.No/Date:3110066521 29.12.2016 Defer Date: , 10.01.2018 Decision: Deferred. |374; 1

Case No.:72/20/82-

ALC4/2016 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:5/82- ALC4/2017 25.10.2017 ; Status:Deferred HQ File :01/82/050/01249/AM17/' RLA File 1 :03/95/040/00732/AM17/, Lic.No/Date:0310810201 i 29.12.2016 ! Defer Date: 10.01.2018 Decision: Deferred. —

1 i 1 1 ;375.

Case No.:71/20/82-

ALC4/2016 Party NameiSUNSHIELD CHEMICALS LTD. Meet No/Date:5/82- ; ALC4/2017 ; 25.10.2017 : Status:Deferred ( HQ File :01/82/050/01248/AM17/' RLA File :03/95/040/00772/AM17/ Lic.No/Date:0310810196! 29.12.2016 ! Defer Date: ' 10.01.2018 Decision: Deferred.

. 376'

Case No.:70/20/82-

ALC4/2016 Party NamerVINDAS CHEMICAL INDUSTRIES PVT. LTD., VIeet No/Date:5/82- , ALC4/2017 25.10.2017 Status:Deferred, HQ File 01/82/050/01247/AM17/ RLA File 03/95/040/00738/AM17/ Lic.No/Date:0310810216 30.12.2016 Defer Date: 10.01.2018 Decision : Deferred. |377:|Case No.:lll/20/82- '|Party Name:SHREEGEN '|MeetNo/Date:5/82- 61

Approved ALC4/2017 25.10.2017 PHARMA LTD ALC4/2016 Lic.No/Date:0910064544l Defer RLA File HQ File Date: :09/24/040/00524/AM 17/ i 02.01.2017 ■ni/R2/050/01288/AM17/ n/o Pharmaceuticals O.M.N0. 35011 242/201 J hbP Vol.l.RA -» p«. - vo,.ka tnese minuics ui as . . . fvir concerned may take necessary action as per decision ot NC. StatusiDeferred Meet No/Date:5/82- Party Name:METROPOLITAN eximchem private LTD. CaseNo.:75/20/82- ALC4/2016 ALC4/2017 25.10.2017 Defer Date: Lic.NoADate:03108102561 RLA File 10.01.2018 :0?/82/050/01252/AM17/' :03/95/040/00706/AM17/' 03.01.2017 Decision: Deferred. StatusiDeferred Meet No/Date:5/82- Party Name:NEW ALLIANCE DYE- CHEMPVT.LTD.,

Case No.:74/20/82-

ALC4/2016 ALC4/2017 25.10.2017 Lic.No/Date:0310810275l 03.01.2017 Defer Date: 10.01.2018 RLA File HO File I ivi_<rv AII*' I ■01/82/050/0125l/AM17/i :03/95/040/00727/ ] iDecision: Deferr^. Status:Deferred Meet No/Date:5/82- Party Name:BALAJI AMINES LIMITED

Case No.:64/20/82-

ALC4/2016 ALC4/2017 25.10.2017 Defer Date: Lic.No/Date:31100665331 RLA File HO File III*' :01/82/050/01241/AM17/' :31/83/040/000_84/AM17/ 10.01.2018 04.01.2017 Decision; Deferred. Case No,:65/20/82- ALC4/2016 IParty Name:DEEPAK 'NOVOCHEM Itechnologies ltd I Meet No/Date:5/82- ALC4/2017 25.10.2017 Lic.No/Date:31100665371 04.01.2017 StatusrDeferredi Defer Date: 10.01.2018 381 RLA File HO File ii\j_»n. A iiv I :01/82/050/01242/AM17/i|:31/83/040/0^1 l_4/>^17/j Decision: Deferred. Status:Deferred Meet No/Date:5/82- iParty Name:JUBILANT

Case No.:40/20/82-

ALC4/2016 ALC4/2017 LIFE SCIENCES 25.10.2017 LIMITED Defer Date: Lic.No/Date:0510401078 RLA File 382; Flic ^ ;01/82/050/01217/AM17/'|:05/23/040/0040yAM17/ 10.01.2018 04.01.2017 Decision: Deferred. 62

• ALC4/2016 LIFE SCIENCES LIMITED ALC4/2017 25.10.2017 HQ File :01/82/050/01234/AM17/ RLA File :05/23/040/00380/AM17/ Lic.No/Date:0510401077 04.01.2017 Defer Date: 10.01.2018 Decision: Deferred. i —

'384 1 i Case No.;32/20/82- ALC4/2016 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:5/82- ALC4/20I7 25.10.2017 Status:Deferredl HQ File :01/82/050/01209/AM17/ RLA File :05/23/040/00474/AMl 7/ Lic.No/Date:0510401159 05.01.2017 Defer Date:13.12.2017 Decision : The Committee noted that information has been called for from the firm in NC j

—

,385 1 CaseNo.;170/20/82- ALC4/2016 Party Name:RONAK CHEMICALS Meet No/Date:5/82- , ALC4/2017 25.10.2017 StatusiDeferred HQ File :01/82/050/01347/AM17/ RLA File :34/24/040/00277/AM 17/ Lic.No/Date:3410042830' 10.01.2017 . Defer Date:13.12.2017| Decision: Deferred. ,

— - .. . . 386. 1 _

Case No.:94/20/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred HQ File :01/82/050/0I27I/AM17/| RLA File :03/95/040/00804/AM17/' Lic.No/Date:0310810430' 10.01.2017 ! Defer Date: ! 10.01.2018 Decision: Deferred. _ 1 1 387 i 1 , CaseNo.:95/20/82- ALC4/2016 Party MameiMANGALAM DRUGS & ORGANICS LIMITED Meet No/Date:5/82- ALC4/2017 ! 25.10.2017 StatusiDeferred HQ File 01/82/050/0I272/AM17/. ilLA File 03/95/040/00566/AM17/ Lic.No/Date:0310810458 11.01.2017 Defer Date:13.12.2017

Case No.: 155/20/82-

ALC4/2016 Party Name:SCOTT EDIL ADVANCE RESEARCH LAB AND EDU LTD Meet No/Date:5/82- ALC4/2017 25.10.2017 Status: Approved 388i HQ File :01/82/050/01332/AM17/ RLA File :22/24/040/00090/AM17/ Lic.No/Date:2210015631. 12.01.2017 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o' Pharmaceuticals O.M.No. 3501 l/295/2015-PI(Norms) dated 22.06.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.l.RA 63

~ ■~r =-= ^ ^ .A :ase No.;83/20/82- 'jParty Name:YASHO N lLC4/2016 INDUSTRIES 1pVT.LTD. _ ; 2 leetNo/Date:5/82- |S lLC4/2017 i 5.10.2017 : tatus:Deferred, 389jj ;: 10 File IrLA File ■ ^ 01/82/050/01260/AM17/1:03/95/040/00805/AM17/i 1 .ic.NoA3ate:03108104821I 2.01.2017 1 Defer Date: 0.01.2018 ■ .>decision: Deferred. ilCase No.:82/20/82- ALC4/2016 'arty Name:BALAJI , I AMINES LIMITED VIeet No/Date: 5/82- ; ^LC4/20I7 25.10.2017 J Status:Deferred |390 HQ File ' :01/82/050/01259/AM17/; RLA File :31/83/040/00132/AM17/! Lic.No/Date:31100665511 13.01.2017 __ ! Defer Date: 10.01.2018 Decision :v

. ' i i i i 1 '391 CaseNo.:81/20/82- ALC4/2016 Party Name;CLEAN 1 SCIENCE AND i TECHNOLOGY PVT.LTD. Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferredi HQ File :01/82/050/01258/AM17/ RLA File :31/83/040/00128/AM17/ Lic.No/Date:3110066548 13.01.2017 Defer Date: 10.01.2018 ; -

  • Decision :v

— ' Case No.:156/20/82- ALC4/2016 1 IParty Name;ESTEEM INDUSTRIES PRIVATE 'IlIMITED Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred 1 I 392 HO File jlRLAFile ■01/82/050/01333/AMI7/!l:17/24/040/00176/AM17/ Lic.No/Date:171000653l 13.01.2017 i Defer Date: 10.01.2018 Decision: Deferred.

Case No.:4/20/82-

ALC4/2016 3931HQ File :01/82/050/01181/AM17/l Party NametALKYL i AMINES CHEMICALS I LTD . ! RLA File :03/94/040/00929/AMl 7/ Meet No/Date:5/82- ALC4/2017 25.10.2017 StatusiDeferred Lic.No/Date:0310810545 16.01.2017 Defer Date: 10.01.2018 Decision: Deferred. No-66/20/82- "^IPartyNametVIRDEV Meet No/Date;5/82- ICase No..66/ZU/«z 'U/ermEDIATES PVT IaLC4/20 17 '■LTD ALC4/2016 25.10.2017 Status:Deferred 394j|HQ pjjg iIrLA File 1:01/82/050/01243/AMl 7/ 'i|:52/24/040/00063/AM17/ Decision : Deferred. |Lic.No/Date:5210042138| Il6.01.2017 Defer Date: 10.01.2018 395!

Case No.:104/20/82-

ALC4/2016 Party Nanie:ARJUN CHEMICALS PVT LTD Meet No/Date:5/82- i ALC4/2017 25.10.2017 Status:Deferred 64

1 1 HQ File :0I/82/050/01281/AM17/ RLA File :04/24/040/00170/AM17/ Lic.No/Date:0410162725 18.01.2017 Defer Date: 10.01.2018 ! Decision : Deferred. , ..... — — ! 1 |396| Case No.;85/20/82- ALC4/2016 1 Party Name:MELOG SPECIALITY ' i CHEMICALS PVT. LTD. MeetNo/Date:5/82- ALC4/2017 1 25.10.2017 Status:Deferred 1 ! ; i HQ File ! :0I/82/050/01262/AM17/' RLA File :03/95/040/00827/AMI7/' Lic.No/Date:031081061 Oj 18.01.2017 ; Defer Date:

10.01.2018 ' Decision : Deferred.

  • .

1 Case No.:86/20/82- ALC4/2016 Party Name:RUSAN PHARMA LTD. Meet No/Date;5/82- 1 ALC4/2017 Status:Deferredi 1 397,1 . 25.10.2017 i HQ File 1 :01/82/050/01263/AM17/' RLA File :03/95/040/00823/AM17/, Lic.No/Date:0310810600i 18.01.2017 ' Defer Date:13.12.2017l Decision: Deferred. j

—

  • — ^ i398

Case No.:76/20/82-

ALC4/2016 Party Name:WANKSONS CHEMICAL INDUSTRIES PVT.LTD. Meet No/Date:5/82- ALC4/2017 25.10.2017 Status:Deferred 1 , HQ File :01/82/050/01253/AM17/ RLA File :03/95/040/00807/AM17/ Lic.No/Date:0310810695 23.01.2017 Defer Date:13.12.2017i Decision : Deferred.

'399! ^ 1 I CaseNo.:97/20/82- ALC4/2016 i Party Name:RESONANCE SPECIALTIES LTD Meet No/Date:5/82- i ALC4/2017 25.10.2017 Status:Deferredi HQ File ; :01/82/050/01274/AM17/; RLA File :03/95/040/00781/AM17/ Lic.No/Date:0310810742j 24.01.2017 i Defer Date:13.12.2017i

... 00

Case No.:99/20/82-

^ ALC4/2016 I Party Name; SM CHEMICAL VAPI PmATE LIMITED MeetNo/Date:5/82- I ALC4/2017 25.10.2017

Status:Deferredl HQ File :0I/82/050/0I276/AM17/, RLA File :03/95/040/00832/AM17/, Lic.No/Date:0310810745i 24.01.2017 Defer Date: 10.01.2018 Decision : Deferred.

401i

Case No.:80/20/82-

ALC4/2016 ' ^arty Name:MELOG SPECIALITY CHEMICALS PVT. LTD. VIeet No/Date;5/82- ALC4/2017 25.10.2017 Status;Deferred' 65

HO File • ;01/82/050/01257/AM17/! :03/95/040/00775_/AM_17/ Lic.No/Date;0310810794i 27.01.2017 . J Defer Date: 10.01.2018 402! Decision: Delerrea. CaseNo.:105/20/82- j ALC4/2016 i Party Name:SAI MIRRA INNOPHARM PVT LTD Meet No/Date:5/82- 1 ALC4/2017 j 25.10.2017 _ , _ j Status:Deferredi HQ File :01/82/050/01282/AM17/i RLA File :04/24/040/00186/AM17/ Lic.No/Date:0410162758j 31.01.2017 ^ J Defer Date:13.12.2017: CaseNo.:77/20/82- ALC4/2016 ; Party NameiPRASGL i CHEMICALS LIMITED REA File , :03/95/040/q0838/AMn/j Meet No/Date:5/82- ALC4/2017 25.10^2017 Lic.No/Date:0310810865j 01.02.2017 . ..J Defer Date; 10.01.2018 HQ File llV^ A :01/82/050/0125^AM17/| i|pecision: Peferrgj-... Status:Deferred Meet No/Date:5/82- ALC4/2017 25.10.2017 J..- i Case No.il61/20/82- : ALC4/2016 1404! ; Party Name:ARVEE ' laboratories ' INDIA PRIVATE '■ LIMITED HO File ' RLA File j :01/8^050^01338//^17/i:q8/24/040/0^^^ Lic.No/Date;0810139667! 07.02.2017 . J Defer Date:13.12.2017 Decision: Deferred.

Case No.:3/20/82-

ALC4/2016 Party Name:INCHEM laboratories i PRIVATE LIMITED _ Meet No/Date: 5/82- ALC4/2017 25.10.2017 Lic.No/Date;0910064656i Status:Deferred! Defer Date:l3.12.2017 RLA File HQ File 1 ii%/ :09/24/040/00497/^17/ 07.02.2017 :01/82/050/01180/^17/; Jpeeision i Pej[en;ed- Status: Approved i Case No.:5/20/82 ALC4/2016 ! Party Name:ONEIRO 1 CHEMICALS PVT LTD Meet No/Date:5/82- ALC4/2017 25.10.2017_ Lic.No/Date:3410042952^ 17.02.2017 Defer RLA File HQ File Date: :34/24/040/00265_/AMj7/ ;01/82/050/01182/AMl7/

TTirTTh/n Pharmaceuticals OM.No. 35011 282/2015 (. 406 a.: /lop.icir\n nt Nl.. triese mmuics ui oo «ppww^ . . . pxTr concemed_inay take necessary action as per decision ot N StatusiDeferred 1407; CaseNo.:177/20/82 ALC4/2016 , Party Name:PAYAL i POLYPLAST PRIVATE i LIMITED Meet No/Date:5/82- ALC4/2017 25.10.2017 66

HQFile :01/82/050/01354/AM17/ RLA File :05/24/040/00478/AM 17/! Lic.No/Date;0510401740l 21.02.2017 Defer Date: ; 10.01.2018 i

. Decision: Deferred. 1 4 CaseNo.:176/20/82- j ALC4/2016 ' Party Name:ACEBRIGHT ; (INDIA) PHARMA PVT ' LTD, 1 Meet No/Date:5/82- t ALC4/20I7 25.10.2017 ! Status: 1 Approved 1 408! HQ File :01/82/050/01353/AMI7/ RLA File ^ :07/24/040/00367/AM17/ Lic.No/Date:07101112031 28.02.2017 1 Defer 1 Date: , Decision : The Committee decided to ratify norms based on the recommendation of D/o' Pharmaceuticals O.M.N0. 3501 l/97/2016-PI(Norms) dated July 2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP VoI.I.Ra! concenwd may take necessary action as per decision of NC. 1 409

Case No.: 175/20/82-

ALC4/2016 Party Name:ARIHANTANAM 1 LIFECARE PVT. LTD. MeetNo/Date:5/82- ALC4/2017 25.10.2017 StatusrDeferred, ! f HQ File :01/82/050/01352/AM17/: RLA File :52/24/040/00081/AM17/^ Lic.No/Date:5210042188 28.02.2017 Defer Date:13.12.2017i Decision : Deferred. 1 CaseNo.:l/2/82- ALC4/2017 Party Name:AUROBINDO ' PHARMA LIMITED MeetNo/Date:5/82- ALC4/2017 25.10.2017 Status: 1 Approved 1 410i HQFile :0I/82/050/00001/AM18/ RLA File :09/24/040/00655/AMI7/ , Lic.No/Date:0910064901! 11.04.2017 Defer Date: Decision : The Committee decided to ratify norms based on SIGN A-3647 or as applied by the firm whichever is less under para 4.07 of HBP Vol.l.RA concerned may take necessary action as ' per decision of NC. f Case No.:55/13/82-' ALC4/2014 Party NameiHETERO' DRUGS LIMITED, Meet No/Date:5/82-t ALC4/2017 ' 25.10.2017 1 Status: Closed ) j 411 HQ File :01/82/050/01058/AM15/ , RLA File :09/24/040/0D269/AMl 5/ ' Lic.No/Date:0910060864' 20.08.2014 !Defer Date | Decision : The committee noted that this case was approved In earlier Meeting No.03/82l dt.17.05.2017. The committee decided to close the case and withdraw the case from agenda Manual Agenda of NC Meeting No. 05/82/2017 Scheduled to be held on 25.10.2017

Case No. B- 01

M.N0.05/AM-I8 Date 25.10.2017 M/s. Satya Deeptha Pharmaceuticals Ltd File No. 01/82/050/00187/AM 16 RLA NO.09/24/040/00009/AM 13 Adv.Auth. No. 0910052284 dated 24 04 2019 uecision. 1 ne committee considered this case for revision of norms as per agenda. The Committee decided to defer this case for want of comments from DoP 67

IVi/o. vjaiya I— •

Case No. B- 02

File No. 01/82/050/00167/AM 14 . . . .A I A (kit <1 O rue i^<j. V w- — i/I.No.05/AM-18 RLA NO.09/24/040/00563/AM 13 Date 25.10.2017 Adv.Auth. No. 0910055393 dated. 15.03.2013 AdV.AUtn. INO. ue mua^Jgo — — Decision: The Committee considered this case for revision of no"ins per agenda. T e Committee decided to defer this case for want of comments from DoP.

Case No. B- 03

File No. G1/82/050/00100/AM 16 i/I.No.05/AWi-18 RLA No.09/24/04a/00711/AM 15 Date 25.10.2017 Ariw Aiith No. 0910061793 dated. 30.03.2015 ".HMPd tn defer this case for want.oLc°n]inen^^^ ivi/a. oaiya .

Case No. B- 04

File No. 01/82/050/01450/AM 12 riiB I*'-'- w I ■— .NO.05/AM-18 RLA NO.09/24/040/00513/AM 12 \jyyf Vt Vrf Vj*/ I 9 Date 25.10.2017 Adv.Autk No. 0910051113 dated. 03.02.2012 AdV.AUtn. [NO. u« iuuo M lu — — D^d^The Committee considered this case for revision ot norms as^agenda. The Committee decided to defer this case for want of comments from DoP, ivi/a. oaiya u»^v..|.^i.i .

Case No. B- 05

File No. 01/82/050/00970/AM 15 rue —- .NO.05/AM-18 RA NO.09/24/040/00665/AM 14 W*Tw/V W W WW • • Date 25.10.2017 Adv.Auth. No. 0910059648 dated. 27.03.2014 AdV.AUtn. NO. uaie^. "Decision- The Committee considered this case for revision of norms as per agenda. Th IVI/O. .— .

Case No. B- 06

Fiie No. 01/82/050/00931/AM 16 l/i.No.05/AM-18 RA NO.09/24/040/00035/AM 16 Date 25.10.2017 AHw Aiitii No. 0910061944 dated. 29.04.2015 AQV.MUUl. INU. yjo =r- "Decision: The Committee considered this case for ™ _t au:.... (^r \A/ant r»f mmiTlfintS frOm UOr . Decision: ine uonniuuec Committee decided to defer this case for want of comments from DoP, 1VI/&. oaiya .

Case No. B- 07

Fiie No. 01/82/050/01212/AM 14 rue iNvj. V .NO.05/AM-18 RA No.09/24/040/00408/AWi 14 1^^ ^5^1 ^•Tr Wt Wf W w~ Wwi » «••• Date 25.10.2017 Adv.Auth. No. 0910058278 dated. 21.11.2013 AdV.AUtn. NO. lUUOO^f O _ Decision: The Committee considered this case for P®' _.. .1 A.! ino//Acn/nnc7'3/AA/l IVI/b. odiya iwA i Fil

Case No. B- 08

e No. 01/82/050/00673/AM 14 ^A ^ tn 4 /Aft/I rilC INU. RLA N M.NO.05/AM-18 O.09/24/040/00102/AM 14 InO vw/^^/V^wIW I \i«i • * Ad Date 25.10.2017 v.Autk No. 0910056373 dated. 18.06.2013 68

Decision: The Committee considered this case for revision of norms as per agenda. The

Case No. B- 09

M.NO.05/AM-18 Date 25.10,2017 File No. 01/82/050/01243/AM 16 RLA NO.09/24/040/00193/AM 16 Adv.Auth. No. 0910062273 dated. 01.07.2015 Decision: The Committee considered this case for revision of norms as per agenda. The Committee decided to defer this case for want of comments from DoP.

Case No. B-10

M.No.05/Al/l-18 Date 25.10.2017 File No. 01/82/050/01166/AM 17 RUK NO.09/24/040/00375/AM 17 Adv.Auth. No. 0910064235 dated. 06.10.2016 Decision: The Committee considered this case for revision of norms as per agenda. The Committee decided to defer this case for want of comments from DoP

Case No. B-11

M.NO.05/AM-18 Date 25.10.2017 File No. 01/82/050/01327/AM 15 RLA NO.09/24/040/00414/AM 15 Adv.Auth. No. 0910061153 dated. 29.10.2014 Decision: The Committee considered this case for revision of norms as per agenda. The Committee decided to defer this case for want of comments from DoP

Case No. B-12

M.NO.05/AM-18 Date 25.10.2017 File No. 01/82/050/00245/AM 17 RLA NO.09/24/040/00626/AM 16 Adv.Auth. No. 0910063149 dated. 22.01.2016 Decision: The Committee considered this case for revision of norms as per agenda. The Committee decided to defer this case for want of comments from DoP

Case No. B-13

M.NO.05/AM-18 Date 25.10.2017 File No. 01/82/050/01044/AM 15 RLA NO.09/24/040/00212/AM 15 Adv.Auth. No. 0910060758 dated. 30.07.2014 Decision: 1 he Committee considered this case for revision of norms as per agenda. The Committee decided to defer this case for want of comments from DoP

Case No. B-14

M.NO.05/AM-18 Date 25.10.2017 File No. 01/82/050/00353/AM 16 RLA NO.09/24/040/00615/AM 15 Adv.Auth. No. 0910061584 dated. 04.02.2015 ^

WMWW IWI IWVIWIWII \Jt I IWI I I |19 GIW 69

Uls. Satya Deeptha Pharmaceuticals Ltd

Case No. B-15

File No. 01/82/050/01237/AM 13 M.NO.05/AM-18 RLA NO.09/24/040/00394/AM 13 Date 25.10.2017 Aflv/AijtK No. 0910054339 dated. 19.11.2012 nuv.rvuiii. www — - "Decision: The Committee considered this case for revision of norms as per agenda. The Committee decided to defer this case for want of comments from DoP, File No. 01/82/050/01238/AM 16 RLA NO.09/24/040/00397/AM 16 I Adv.Auth. No. 0910062672 dated. 05.10.2015 Decision: The Committee considered this case for revision of norms as per agenda. The

Case No. B-16

Wl.No.05/AM-18 Date 25.10.2017

Case No. B-17

M.NO.05/AM-18 Date 25.10.2017 File No. 01/82/050/00101/AM 15 RLA NO.09/24/040/00482/AM 14 AHw AiitK No. 0910058730 dated. 26.12.2013 Decision: The Committee considered this case for revision of norms as per agenda. UeClblUII. I lie x-'Uiiniiinw.w

r\AD The nommittee decided to defer this case for want of comments from DoP.

Case No. B-18

M.NO.05/AM-18 Date 25.10.2017 File No. 01/82/050/00289/AM 15 RLA NO.09/24/040/00297/AM 14 Ariw Anth. No. 0910057666 dated. 24.09.2013 Decision: The Committee considered this case for revision of norm^s as per agenda. The Trnm LjOp'. nnmrnittPR decided to defer this case for want of comments from DoP^ M/s. Shasun Pharmaceuticals Ltd

Case No. B-19

M.NO.05/AM-18 Date 25.10.2017 File No. 01/82/050/00384/AM 14 RLA NO.04/24/040/00063/AM 14 Adv.Auth. No. 0410147551 dated. 27.06.2013 Decision: The Committee considered case ror ^ o»^ per agenda. The f nmmittPP ripcided to defer this case for want of comments from DoP. M/s. Shasun Pharmaceuticals Ltd

Case No. B- 20

File No. 01/82/050/00387/AM 14 M.NO.05/AM-18 RLA NO.04/24/040/00065/AM 14 Date 25.10.2017 AHw Anth No. Q410147559 dated. 27.06.2013 DPcision: The Committee considered this case for fixation of norms as per agenda. The 70

Case No. B- 21

M.NO.05/AM-18 Date 25.10.2017 Wl/s. Shasun Pharmaceuticals Ltd File No. 01/82/050/01124/AM 14 RLA No.04/24/040/00183/AI/l 14 Adv.Auth. No; 0410152258 dated. 27.11.2013 Decision: The Committee considered this case for fixation of norms as per agenda. The

Case No. B- 22

M/s. Biological E Ltd M.NO.05/AM-18 File No. 01/82/050/01473/AM 13 Date 25.10.2017 RLA NO.09/24/040/00535/AM 13 Adv.Auth. No. 0910055011 dated. 11.02.2013 File No. 01/82/050/01475/AI/l 13 RLA No.09/24/040/00534/AI/I 13 Adv.Auth. No. 0910055012 dated. 11.02.2013 File No. 01/82/050/00665/AM 14 RLA NO.09/24/040/00118/AM 14 Adv.Auth. No. 0910056424 dated. 21.06.2013 File No. 01/82/050/00097/AM 15 RLA NO.09/24/040/00549/AM 14 Adv.Auth. No. 0910059124 dated. 30.01.2014 Decision: The Committee considered this case for revision of norms as per agenda. The Committee decided to defer this case for want of comments. 71

^1 F- No.35011/252/2014-PI (Norms) Government of India Ministry of Chemical & Fertilizers Department of Pharmaceuticals Udyog Bhawan, New Delhi, the October, 2014 Office Memorandum

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

2009-14 Case of M/s Mylan Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/128/AM- 15/DBS-3/174 dated the 08/05/14 vide which application from M/s. Mylan Labs Ltd was sent to this Department for fixation of norms under pai-a: 4.7 for the export of Sertraline Hcl. This department has examined the matter and the following s. Qty. Recommended kg/kg. No. Import Item 1. Tkralone 3.27 2. Methanol 4.44 3. Sodium borohydride 0.331 4. D (-) Mandelilc acid 0.392 5. n-Heptane 0.56 This issues with the approval of Director (Cost). (Bamali Khastgir) Under Secretary to the Government of India Directorate General of Foreign Trade, Department of Commerce, (Shri M.V. Singh, FTDO), Udyog Bhawan, New Delhi 1

o F. NO.35011/21/2017-PI (Norms) Government of India Ministry of Chemical & Fertilizers Janpath Bhawan, New Delhi, Dated: September 25, 2017 Office Memorandum

Subject: - Fixation of norms under para 4.^olfiand Bo_ok_ofPj:ocedures (Vol.!) 2015-20 Case of msry^

Labs Ltd.^ The undersigned is directed to refer to DGFT U.O.No. 01/82/50/957/AI/l-17/DES-3/641 dated the 15/12/2016 vide which application from M/s. Morepen Labs Ltd. was sent to this Department for fixation of normsTjnder para: 4.7 for the export of Sitagllptin Phos]3hate (APIs I Bulk Drugs). This department has examined the matter and the following norms are furnished under-para 4.7 of Hand Book of Procedures (Vol.1) 2015-20:- " , , ' . S. No. Import Item Norms Recommended for 1kg Export 1 2.4,5 Trifluorophenvlacetic Acid a OC ■2 Meldrum Acid 0.77kq . 3 3-fTrifluorome±hyh-.5 fi 7 R-TpfrflhyHrn-[l 9 4] Tjdaf§Io74^-Al PyrazineTlV^rachlorlde 2.) This issues with the approval of competent authority. (Parvpen Kumar) E-mail: parveen.19@gov.in Ph:-23352298 (Shrl S.K. Panigrahi), Udyog Bhawan, New Delhi, E-mail: sk.panigrahi@nic.in Ph: 2306,1562, Extn.269

' \V^ O ' F.No.35011/340/2012-PI(Noniis> _

Government of India Ministiy of Chemical & Fertilizers •

Udyog Bhawan, New Delhi, the ^ September, 2012. Office Memorandum Sub: Fixation of norms imder para 4.7 of Hand Book of Procedures (Vol.1) 2009- 14 Case of M/s ^ The imdersigned is directed to refex to pa^m3.No^0i/82/^0_/14:^2/^J^yO^ 22/03/12 vide which .an application from IWs Alkaloids Corporation Ltd was sent to tliis Depaifrnent for fixation of noims under para: 4.7 for the export of Noscapine BP/Noscapine Hydrochloride BP. This department has examined the matter and the following corhments .^e furnished imder para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-

^ S.No. Import Item Qty. Recommended kg/kg. 1.Noscapine Crude Content 95% 1.085 2. This issues with the approval of Director (Cost). (N.N.Aliuja) Section Officer PI-Norms (Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi. O u n

o F. NO.35011/287/2016-PI (Norms) Government of India ■Ministry of Chemical & Fertilizers 4"^ Room No. 302, 3'" Floor, Janpath Bhavi/an New Delhi, Dated: September 26, 2017 Office "Memorandum -SubJect:z..Flxation_of_norms^undeiLpai:a Al. oS -Hand_BAOk. oJ J^riDcejiures.jypU),^009^14_Ca.se_of J/l/s Fresenius KabI Oncology Ltd. The undersigned is. directed to refer to DG!^ U.O.No. 01/82/050/00425/AM-17/DES-3/358 dated the' 17/08/2016 vide which application from WI/s Fresenius KabI Oncology Ltd.. was sent to this Department for fixation of norms under para: 4.7-Torthe export of Irinotecan Hydrochlorlde Injection In 40 mg , 100 mg, 300 mg and 500 mg strengths. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-

Product to be Exported Raw materials to be Imported Description Qty. 8. NO Description Quantity for 1000 vials 40 mg 100 mg 300 mg 500 mg Irinotecan. Hydrochlorlde Injection,^ 2 (each mg contains 20 mg Irinotecan Hydrochloride) 1000 Vials 1. In'notecan Hydrochloride Trihydrate. 44 gm 110 gm 315 gm 525 gm 2. Glass Vials of appropriate size Relevant, as per packing policy 3. ' Rubber Stopper 20 mm 2. ! This issues with the approval of competent authority. (Parveen Kumar) Phone: 23352298 Email: parveen. 19@Qov.in- (Shri S.K. Panigrahi, Economic Officer, DES-I Phone No: 23061562, (269), Email; sk.paniarahi@nlc.ih -

o (^p F. NO.35011/296/2016-PI (Norms) Government of India OfficeMemorandum Room No. 302, 3^*^ Floor. Janpath Bhawan New Delhi, Dated: September 26. 2017 -Subject:^ixati6n_ofj3orms_under_para.4.7_of-Hand3ook-Of.Procedures-(Vol.l)-2009=.14-Case-of-M/s.Jubilant- Generics^Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/050/00420/AM-17/DES-3/367 dated the 17/08/2016 vide which application from M/s Jubilant Generics Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export-of Oxcarbazepine Tablets in 150 mg, 300 mg -8r^00 mg. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1)2009-14: - ' . . . .t' —i Product to be Exported Raw materials to be imported r Description Qty. s. NO Description Quanpty for 1000 tablets of 150 mq 300 mg 600 mg Oxcarbazepine Tablets 150 mg,, 300 mg & 600 mg 1000 tablets 1. Oxcarbazepine 153.00 gm 306.00 gm 612.00 gm 2. Hypromellose (603) 2.25 gm 4.50 gm 9.00 gm 3. Hypromellose (615) 1.125 gm 2.25 gm 4.50 gm 4. Cellulose, Micrdcrystalline 15.30 gm 30.60 gm 61.20 gm . 5. Crospovidone 23.62 gm 47.25 gm 94.50 gm 6. Silica, Dental 0.90 gm 1.80 gm 3.60 gm 7. Magnesium Stearate 1.80 gm 3.60gm 7.20 gm 8. Opadry03F510008- 3.60 gm 7.20 gm 14.40 gm 9. Film Trans PVC/PE/PVDC- Relevant, may be considered as per packing policy 10. Printed Aluminium Foil 2. (Shri S.'K. Panigrahi, Economic Officer, DES-I Phone No: 23061562, (269), Email: sk.paniqrahi@nic.in (PaiVeen Kumar) Phone: 23352298 Email: parveen.19@aov.in PS

Q F. NO.35011/286/2016-PI (Norms) Government of India Office Memorandum 1 ,1< Room No. 302, 3'" Floor, Janpath Bhawan New Delhi, Dated: September 26, 2017

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

Fresenius Kabi India Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/050/00382/AM-17/DES-3/368 dated the 17/08/2016 vide which application from IW/s Fresenius Kabi India Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Sodium ChlorideO.9% infusion solutions in 500 ml, 1000 ml, 100 ml and 250 mg packings.JThis'department has examined the matter and the following norms are furnished under para-4.7 of Hand-Book of Procedures (Vol.1) 2009-14:- I • Product tp be Exported Raw materials to be imported Description Qty. S. NO Description Quantity for 1000 bottles 500 ml 1000 ml 100 ml 250 ml Sodium Chloride 0.9% infusion solutions in 500 ml, 1000 ml, 100 ml and 250 mg packings 'MOOO bottles Ship shape 'break Off Infusion blue (Plastic component) Required and may be considered as per packing policy Ship shape break Off Injection Ship shape corpus Infusion Ship shape corpus Injection with PP membrane 0.8 SF9.195/135._ Plastic film Non PVC for.primary packing SF9 195/140 Plastic film non PVC for primary packing 0FR2 120/524 Plastic film Non PVC for secondary packing 8. 0FR2 150/524 Plastic film noh PVC for secondary packing 9. UFR2 '150/524 Plastic filrfi ndh PVC for secondary packing " ' ^ ' ' 10. ■SF9 195/95 Plastic filnTnon PVC for Primary packing 11. SF9 195/100 Plastic film non PVC for Primary packing" 12. Hot stamping foil .a. 13. (Stamping foil) thermal transfer print ribbon barcodeblack 14. (Stamping Foil) (barcode white) Hot print ribbon ....21-

-2- 15. Corrugated Boxes 16. Shipper Label (385x285x220 mm FFX karton) 17. Direction sheet insert 100 ml, 250 ml, 500 ml & 1000 ml Leaqfiets free flex NS EP (385X285X220 MM FFX karton) 18. Sodium Chloride Pharma Grade (API) 4.680 gm 9.290 gm 0.945 gm 2.362 gm 2.) This Issues with the approval of competent authority. (Shri S.K. Panigrahi, Economic Officer, DES-i Phone No: 23061562, (269), (Parveen KuitiarJ Phone: 23352298 Erfiall: parveen.19@aov.ln

F. NO.35011/281/2016-PI (Norms) Government of India Janpath Bhawan, Nev^^ Delhi, Dated: September 15, 2017 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.!) 2015-20 Case of M/s

Sentiss Pharma Pvt. Ltd. The undersigned Is directed to refer to DGFT U.O.No. 01/82/50/365 & 616/AM-17/DES-3/427 & 509 dated the 19/08/2016 & 31/08/2016 vide which application from M/s Sentiss Pharma Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Oftahist (Olopatadine Eye Solution 0.1% vial of 5ml). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2015-20:- S.No. Import Item Norms Recommended 1 Olopatadine Hcl 5.65mg for one eye/ear drop of 5ml 2.) (Shri S.K. Panigrahi, Economic Officer, DES-I Phone No: 23061562, (269), Email: sk.paniqrahi@nic.in (Parveen Kumar) Phone: 23352298 Email: parveen.19@qov.in 9

F. No.35011/225/2016-PI (Norms) Government of India Ministry of Chemical & Feitilizers Office Memorandiiin Shastri Bhawan, New Delhi, Dated; September 12, 2017 Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2015-20 Case of M/s Orbit Life Sciences Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/384/AM-I7/DES-3/439 dated the 19/08/2016 vide which an application from M/s Orbit Life Sciences Pvt. Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Cefpodoxime Proxetil. This department has examined the matter and the following comments are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2015-20:- S.No. Import Item Qty. Recommended kg/kg. 1. 7-Amino Cephalosporanic Acid(7-ACA) 0.956kg 2. Boron Triflouride 0.614kg 3. Methanol 1.7kg 4. Sulfolane 1.29kg 5. Methylene Chloride 4.29kg 6. 2-Mecraptoben Zpthia2oly(z)-2-2(2-Aminothiazole-4-YL)-2- Methoxyimino Acetate (MAEM) 0.956kg 7. Eno-Carbon 0.1kg 8. Acetone 0.54kg 9. N,N Dimethyl Acetamide 2.02kg 10. 18-Crown-Ether 0.022kg I I. Chioro Ethyl Isopropyl Carbonate 0.55kg 12. Sodium Iodide 0.0175kg 2.) Tliis issues with the approval of competent authority. (Parveen Kumar) E-mail: parveen. 19@gov.in Ph:-23352298 (Shri S.K. Panigrahi), Udyog Bhawan, New Delhi. E-mail: sk.panigrahi@nic.in Ph: 23061562, Extn.269

F. NO.35011/30/2017-PI (Norms) ® Government of India ^ Janpath Bhawan, New Delhi. Dated; September 19, 2017 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.I) 2015-20 Case of

M/s Nifty Labs Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/859/AM-17/DES-3/670 dated the 21/12/2016 vide which application from M/s. Nifty Labs Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of 2-(Chloro l/Iethyl)-3-Methyl-4- (2,2,2-Trifluoroethoxy)Pyridine Hcl. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2015-20:- S. No. Import Item Norms Recommended for 1kg Export 1. 2,3-Dlmethyl Pyridine 0.76kg 2. Methylene Dichloride 0.24kg 3. 2.2.2-Trifluoro Ethanol 0.76kg 2.) (Parveen Kumar) E-mail: parveen.19@gov.in Ph:-23352298 (Shri S.K. Panigrahi), Udyog Bhawan, New Delhi. E-mail: sk.panigrahi@nic.in Ph: 23061562, Extn.269

F. NO.35011/97/2016-PI (Norms) Government of India — Udyog Bhawan, New Delhi, Dated: July, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of

M/s Acebright (India) Pharma Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1802/AM-17/DES-3/91 dated the 11/5/16 vide which application from M/s Acebright (India) Pharma Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Tenofovir Disoproxil Fumarate (TDF). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S.No. Import item Norms Recommended for 1kg Export 1 (R)-9-(2-phosphono methoxy propyl) adenine 0.69kg 2. (Rajkumar) PH:-23071162 1—

F. NO.35011/36/2017-P1 (Norms) Government of India Room No. 302, 3^ Floor, Janpath Bhawan New Delhi, Dated: October 17, 2017 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of

M/s Alembic Pharmaceuticals Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/050/00826/AM-17/DES-3/801 dated the 26/12/2016 vide which application from M/s Alembic Pharmaceuticals Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Clarithromycin enteric coated granules 30% and 42%. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14: - Product to be Exported Raw materials to be imported Description Qty. S. No. Description Quantity for 1000 kg Clarithromycin enteric coated granules 30% 1000 kg 1. Clarithromycin 273.00 kg 2. Acetone 698.00 kg Clarithromycin enteric coated granules 42% 1000 kg 1. Clarithromycin 403.00 kg 2. Acetone 1031.50 kg 2. (Shri S.K. Panigrahl, Economic Officer. DES-I Phone No: 23061562, (269), Email: sk.paniqrahi@nlc.in (Parveen Kumar) Phone: 23352298 Email: parveen.19@qov.in

F. No.35011/52/2015-PI (Norms) Govemment of India Ministry of Chemicals & Fertilizers Udyog Bhawan,New Delhi, Dated the September, 2015 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s Micro

Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1151/AM-15/DES-3/1060 dated the 13/01/15 vide which application from M/s. Leben Labs Pvt Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Premix for Nifuroxazide Capsules of 362 mg Containing 200mg Nifuroxazide. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S.No. Import Item Qty. Recommended kg/kg. 1. Nifuroxazide EP 0.5575 (Bamali Khastgir) Under Secretary to the Govemment of India Phone:2307I162

F. NO.35011/729/2015-PI (Norms) Government of India 2A^w Office Memorandum Udyog Bhawan, New Delhi, Dated; 27 April, 2016

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

WWs-Arrah=i^ariTia=tidv_ The undersigned Is directed to refer to DGFT U.O.No. 01/82/50/709/AM-16/DES-3/781 dated the 10/8/15 vide which application from M/s Anuh Pharma Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Betamethasone Valerate BP/USP/EPflPU This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S.No. import Item Norms Recommended for 1kg Export 1 Betamethasone BR^USP/EP/IP 0.915kg 2 ^rimgtbyLOrtho-Valerate —^ —0::?§§kg— 2. (Rajkumar) PH:- 23071162

F. No.35011/106/2015-PI (Norms) Government of India Ministry of Chemicals & Fertilizers 24^ Udyog Bhawan,New Delhi, Dated the August, 2015 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14

Case ofM/s4rCA Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1224/AM-15/DES- 3/1074 dated the 13/01/15 vide which application from M/s, IPCA Labs Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Prednisolone Sodium Phosphate. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (VoLl) 2009-14:- S.No. Import Item Qty. Recommended kg/kg. 1. Prednisolone 0.839 Bamali Khastgir) Phone:23071162

isi F. No.35011/28/2013-PI (Norms) Government of India Ministry of Chemical & Fertilizers Udyog Bhawan, New Delhi, the April, 2015 Office Memorandum Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s. Vital Labs F.td. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/670/AM13/DBS-3/831 dated the 22/01/15 vide which an application from M/sr-¥itaFT^aba-Ltd-was sent to this Department for fixation of norms under para: 4.7 for the export of Methyl Cobalamin (Meeobalamin). This department has examined the matter and the following comments are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S.No. Import Item Qty. Recommended kg/kg. 1. Vitamin B 12 (Cyanocobalamin) 0.95 2. This issues with the approval of Director (PI). (Bamali Khastgir) Phone- 23071162

F. NO.35011/868/2015-PI (Norms) Government of India Office Memorandum 252' Udyog Bhawan, New Delhi, Dated: 24 May, 2016

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of

M/s Stermone-Cbemicals Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1685/AM-16/DES-3/1740 dated the 2/3/16 vide which application from 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.1) 2009-14:- S.No. import item Norms Recommended for 1kg of export 1 Betamethasone 1.00kg 2. (Rajkumar) PH:-23071162

F. NO.35011/119/2016-P1 (Norms) Government of India Office Memorandum (S) Udyog Bhawan, New Delhi, Dated: July, 2016

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of

M/s Anuh Pharma I tcL> The undersigned is directed to refer to DGFT U.O.No. 01/82/50/97/AM-17/DES-3/128 dated the 23/5/16 vide which application from M/s Anuh Pharma Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of B^fa^odium-Phosphat^etamethasone sodium phosphate^. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S.No. Import item Norms Recommended for 1kg Export 1 Betamethasone 0.78kg 2. (Rajkumar) Under Secretary to the Government of india PH:- 23071162 (Shri M.V. Singh. FTDO),

F. NO.35011/52/2017-PI (Norms) Government of India © Janpath Bhawan, New Delhi. Dated: September 25, 2017 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2015-20 Case of

M/s Sun Pharmaceuticals Industries Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/906/AM-17/DES-3/664 dated the 21/12/2016 vide which application from M/s Sun Pharmaceuticals Industries Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Tobramycin 300mg/5ml Nebullser Solution. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2015-20:- S.No. Export item Import item Norms Recommended for 100 ampoules 1 Tobramycin 300mg/5ml Nebullser Solution Tobramycin PH. EUR. 30.6gm 2.) (Parveen Kumar) E-mail: parveen.19@gov.in Ph:-23352298 (Shri S.K. Panigrahi), Udyog Bhawan, New Delhi. E-mail: sk.panigrahi@nic.in Ph: 23061562, Extn.269 9 o

F. NO.35011/681/2015-PI (Norms) Government of India Ministry of Chemicals & Fertilizers Office Memorandum Udyog Bhawan,New Delhi, Dated: 1 February, 2016

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s i>rini

The undersigned is directed to refer to DGFT U.O.No. 01/82/50/865/AM-16/DES-3/924 dated the 8/9/15 vide which application from M/s Srini Pharmaceuticals Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of l^^phenolate Mofetil. This department has examined the matter and the following norms are furnished under pSa 4.7^ Hand Book of Procedures (Vol.1) 2009-14:- S.No. Import Item Norms Recommended for 1kg Export 1. Mycophenolic acid 0.941kg 2. Methand 2^g' 3. MorpI^6linoethanol 1.05kg 2. (Rajkumar) Phone:23071I62

F. No.35011/737/2015-Pl (Norms) Government of India Udyog Bhawan, New Delhi, Dated: June, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14

Case of M/s Orch Labs India (P) Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1862/AM- 16/DES-3/176 dated the 10/6/16 vide which application from M/s Orch Labs India (P) Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of L-menthyl glyoxylate hydrate (MGH). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14:- S.No. Import item Norms Recommended for 1kg Export 1 Glyoxylic acid 50% 0.752kg 2 cyclohexane 1.41kg 3. L(_-:) tAeu-VVcA 2. C) (Rajkumar) PH:- 23071162 (Shri M.V. Singh, FTDO). 7^

F. NO.35011/41/2017-PI (Norms) Government of India Office Memorandum 358 Shastri Bhawan, New Delhi, Dated: September 27, 2017 Sub: - Fixation of norms under para 4.7- Application of M/s Jubilant Generics Ltd., for export of Valsartan tablets in 40 mg, 80 mg,180 mg and 320 mg. The undersigned is directed to refer to DGFT U.O. No. 01/82/050/00885/AM-17/DES-3/804 dated 28/12/2016 and subsequent letter from M/s Jubilant Generics Ltd., for fixation of norms against export of Valsartan tablets in 40 mg, 80 mg,180 mg and 320 mg. The applicant has requested for import of relevant bulk drug i.e. Valsartan only. 2. The SIGN for tablets are published vide S. No. A-412 and the application may be processed accordingly. 3. This issues with the approval of competent authority (Shri S.K. Panigrahi, Economic Officer, DES-I Phone No: 23061562, (269), Email: sk.panlqrahi@.nic.in (Parveen Kumar) Phone: 23352298 Email: parveen.19@qov.in

F. No.35011/404/2012-Pl (Norms) Government of India Ministry of Chemical & Fertilizers <ij ^5 Udyog Bhawan, New Delhi, the 25"' April, 2013 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s Cadila

Healthcare Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/342/AMI3/DES-3/I267 dated the 13/03/13 vide which an application from M/s. Cadila Healthcare Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Divalproex Sodium Capsule/Tablets. This department has examined the matter and the following comments are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S.No. Import Item Norms recommened for 1 No. 125 me Sorinkle 125 me DR 250 me DR 500 me DR Cansule Tablet Tablet Tablet 1. Divalproex sodium 134.625 mg 134.625 mg 269.25 mg 538.50 mg 2. Hypermellose 3 CPS 12.688

Methyacrylic Acid Copoly Dispersion 56.89 43.8475 80.0 160.0 4. Microcrystalline Cellulose Spheres 89.667

Triethyl Citrate 5.583 1.50 2.40 4.80 6. Povidone K 30

9.50 19.0 38.0 7. - Microcrystalline Cellulose (Avicel PH 101)

52.94 105.87 211.75 8. Magnesium Stearate

2.37 4.75 9.50 9-17 Bottles and caps Relevant, As per packing policy. 2. This issues with the approval of Director (Cost). (Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi. (Raj Kumar) Under Secretary, to the Government of India Pl-Norms ri

F. NO.35011/242/2016-PI (Norms) Government of India Ministry of Chemicals & Fertilizers Shastri Bhawan, New Delhi, Dated: September 11, 2017 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2015-20 Case of M/s

Shreegen Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/493/AM-17/DES-3/429 dated the 19/08/2016 vide which application from M/s. Shreegen Pharma Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Rosuvastatin Calcium. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2015-20:- S.No. Import Item Norms Recommended 1. (4R-Cis)-6-[(Acetyloxy) Methyl]-2,2- Dimethyl-1,3-Dioxane-4-Acetic Acid, 1,1- Dimethyl Ethyl Ester (D5) 1.87kg 2. [Z-7]4-(4-Fluorophenyl)-6-lsopropyl-2-[(N- Methyl-N-Methylsulfonyl) Amino] Pyrimidine-5-yl-Methanol 1.87kg 2.) (Parveen Kumar) E-mail: parveen. 19@gov.in Ph:-23352298 (Shri S.K. Panigrahi), Udyog Bhawan, New Delhi. E-mail: sk.panigrahi@nic.in Ph: 23061562, Extn.269 ^9'

89t3 F. No. 35011/295/2015-PI (Norms) Government of India Office Memorandum Shastri Bhawan, New Delhi, Dated: June 22, 2016 Sub: - Fixation of norms under para 4.7- Application of M/s Jodas Expoim Pvt. Ltd., for Meropenem Injection Vial. 1 gm. The undersigned is directed to refer to DGFT U.O. No. 01/82/050/1321/AM-15/DES-3/18 dated 01/05/2015 and subsequent letter from M/s Jodas Expoim Pvt. Ltd. for fixation of norms against export of Wleropenem Injection Vial. 1 gm. This department has examined the matter and following norms are recommended against this application. Product to be Exported Raw materials to be Imported Description Quantity Description Quantity as per vial Meropenem Injection 1 gm. 1 vial Meropenem Thhydrate (Non-Sterile)- 1.0857 gm 2. This issues with the approval of Director (Pharma Industry). Department of Commerce. (Shri MV Singh, FTDO), Udyog Bhawan, New Delhi. (Raj Kumar) Phone: 23071162 Uspi3-Pharma@nlc.in

F. No.35011/282/2015-PI (Norms) Government of India Ministry of Chemicals & Fertilizers Udyog Bhawan,New Delhi, Dated the October, 2015 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s Oneiro

Chemicals Ltd. The undersigned is directed to refer to DGFT U.O.No. 0I/82/50/541/AM-16/DES-3/225 dated the 29/06/15 vide which application from M/s. Oneiro Chemicals Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of 4,5,6,7-Tetrahydro (3,2,0) Thiono Pyridine Hydrochloride. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S.No. Import Item Qty. Recommended kg/kg. 1. Thiophene-2 Ethylamine 0.87 2. Methanol 1.49 3. Methyene Chloride 0.79 (Barnali Khastgir) Phone:23071162

F. N0.35OII/97/2OI6-PI (Norms) Government of India Office Memorandum Udyog Bhawan, New Delhi, Dated: July, 2016

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

M/s Acebright (India) Pharma Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1802/AM-17/DES-3/91 dated the 11/5/16 vide which application from M/s Acebright (India) Pharma Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Tenofovir Disoproxll Fumarate (IDF). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:- S.No. Import item Norms Recommended for 1kg Export 1 (R)-9-(2-phosphono methoxy propyl) adenine 0.69kg 2. (Rajkumar) PH:- 23071162

Affioxycilin Capsules 2S0 mg (Each capsule containing Amoxycllin Trihydrate equivalent to 2S0 mg of Amoxycillin) 1000 Capsules 1 Amoxycillin Trihydrate 292.68 gm ASS Deleted A56 Amoxycillin oral suspension (Amoxycillin Syrup) 12S mg/5 ml, 60 ml bottle (Each 5 ml contains Amoxycillin Trihydrate equivalent to 12S mg of Amoxycillin) 1000 Bottles 1 Amoxycillin Trihydrate 1807.70 gms A57 Amoxycillin Trihydrate (From 6 APA Route) 1 kg 1 6 APA 0.568 kg 2 D(-) Para Hydroxy Phenyl Glycine Methyl Potassium Dane Salt OR 0.832 kg 2 a) D(-) Para Hydorxy Phenyl Glycine base 0.4687 kg b) Methyl Acetoacetate 0.3568 kg c) Methanol 0.2922 kg 3 Triethylamine 0.029 kg 4 Methylene chloride 0.330 kg 5 Acetone OR 0.250 kg Iso Propyl alcohol 0.421 kg 6 N,N-Dimelhyl Acetamide 0.099 kg 7 Pivaloyl chloride 0.330 kg ASS Amoxycillin Trihydrate (From Penicillin G Route) 1 kg 1 Pencillin G Potassium First Crystals 1.664 BOU 2 Pencillin G amidase (Enzyme) 0.852 gm 3 D(-) Para Hydroxy Phenyl Glycine Methyl Potassium Dane Salt OR 0.832 kg 3 a) D(-) Para Hydroxy Phenyl Glycine base 0.4687 kg b) Methyl Acetoacetate 0.3568 kg c) Methanol 0.2922 kg 4 Triethylamine 0.029 kg 5 Methylene chloride 0.330 kg 6 Iso Propyl alcohol 0.421 kg 7 N,N-Dimethyl Acetamide 0.099 kg 8 Pivaloyl chloride 0.330 kg A59 Ampicillin and Cloxacillin Capsules (250 mg +250 mg) (Each capsule contains Ampicillin Trihydrate equivalent to 250 mg of Ampicillin and Cloxacillin Sodium equivalent to 250 mg of Cloxacillin) 1000 Capsules 1 Ampicillin Trihydrate 294.5 gms 2 Cloxacillin Sodium 277.95 gms A6

w/w & Neomycin Sulphate 0.5% wAv. 3.5 gms. each. 2 Neomycin Sulphate 1.837 gms. A232 Famotidine 1 kg 1 1.3 Dicholoro Acetone 1.89 kg 2 Guanyl Thiourea 1.83 kg 3 Dimethyl Formamide 2.29 kg 4 Thiourea 1.50 kg 5 Dimethyl Sulfoxide 2.15 kg 6 Sulfamide 1.11 kg 7 Acrylonitrlle 5.56 kg A233 Fenbendazole (Meta Chloro Aniline Route) 1 kg I Thio Urea 0.6 kg 2 Methyl Chloro Formate 1.60 kg 3 Thio Phenol 1.00 kg 4 Hydrazine Hydrate 80% 1.10 kg 5 Meta Chloro Aniline 2.10 kgs 6 N-Butanol 3.20 kgs 7 Acetic Anhydride 4.00 kgs 8 Methanol 17.50 kgs A234 Fecpdus Fumarate BP 1 kg 1 Maleic Anhydride 0.880 kg A^ ^lucloxacillin capsules 250 mg. (Each capsule contains Flucloxacillin sodium equivalent to 250 mg of anhydrous Flucloxacillin) 1000 Capsules 1 Flucloxacillin Sodium 277.47 gms A236 Flucloxacillin Injection (250 mg./vial) (each vial containing Flucloxacillin Sodium equivalent to 250 mg of anhydrous Flucloxacillin 1000 vials 1 Flucloxacillin Sodium 285.63 gms A237 Flucloxacillin oral solution (Flucloxacillin syrup) 125 mg/5 ml, 60 ml bottle (Each 5 ml contains Flucloxacillin sodium equivalent to 125 mg of anhydrous Flucloxacillin) 1000 Bottles 1 Flucloxacillin Sodium 1713.80 gms A238 Flucloxacillin Sodium 1 kg. I Amino Penicillanic Acid (6 APA) OR 0.502 kg 1 a) Pencillin G Potassium First Crystal 1.606 BOU b) Penicillin G Amidase Enzyme 0.842 gm c) Methylene Chloride/ Butyl Acetate 0.502 kg 2 FCMIC Chloride OR 0.706 kg 2 a) 2-Fluoro-6-Chloro Benzaldehyde 0.806 kg b) Hydroxylamine Sulphate 0.537 kg A29 a ^

(To be published In the Gazette of India Extraordinary) (Part 1-Section 1) Government of India Ministry of Commerce and Industry Department of Commerce Directorate General of Foreign Trade Public Notice No. 64 /2015-2020 New Delhi: Dated 17"^ March, 2018 Sub:- Standard Input Output Norms under Chemical & Allied Product Group - reg. In exercise of the powers conferred under Paragraph 2.04 of the Foreign Trade Poiicy SJw-»2A3e73,A.3674,A-3675,M676 .«1 A.3677 for e>poA pr.d«« m. details of which are as given below. fSION 1 SI. No. (1) A-3M5 A-3646 A-3647 l/\YO Description of Export Item Alendronate Sodium Tablets 70 mg (Each Tablet contains Alendronate Sodium eauivalent to 7n mg Alendronic acid) Export Quantit 1000 Tablets A-3548 Amikacin Sulphate Injection 500 mg/2ml (Each 2 ml vial contains Amikacin Sulphate equivalent to Amikacin 500 mg) 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) Amoxicillin & Clavulanic Acid suspension 228.5 mg/5 ml in 100 ml bottles. (Each 5 ml contains Amoxicillin Trihydrate equivalent to Amoxicillin 200 mg and Potassium Clavulanate equivalent to Clavulanic acid 28.5 mg} A-3649 A-3850 A-3651 A-3652 Ampicillin and Sulbactam 750 mg for injection' (each vial contains Ampiallin Sodium equivalent to Ampicillin 500 mg and Sulbactam Sodium equivalent to Salbactam 250 mg} Ampicillin injection 500 mg (each vial contains Ampicillin Sodium equivaient to Ampicillin 500 mg) 1000 vials 1000 Tablets 1000 bottles Import Items Alendronate Sodium Trihydrate Amikacin Sulphate 1) Amoxicillin Trihydrate Quantity allow^ [6} 93.152 gm 715.81 gm 1024.238 gm 2) Diluted 303.773 Clavulanate 9"^ Potassium (1:1) "i Amoxicillin | 4200gm Trihydrate 2. Diluted Clavulanate Potassium (1:1) 2) Sulbactam Sodium 1414.193 gm 583.77 gm 302.22 gm 1000 vials Atorvastatin Tablets 10 mg(each tablet contains Atorvastatin Calcium Trihydrate equivalent to 10 mg Atorvastatin) — Benzylpenicillin Injection 5 Lac units (300 mg) (each vial contains Benzylpendllin Sodium equivalent to Benzylpendllin 300 mg} 1000 I Atorvastatin Tablets 1 CalcliumTrihydrate 11.059 gm 1000 vials Benzylpenicillin Sodium \Pl

A-3653 1 C C { € / efadroxil (250 mg) and Potassium Javulanate (62.5 mg) Dispersible Tablets each tablet contains cefadroxil monohydrate quivalent to 250 mg Cefadroxil on \nhydrous basis and Clavulanate potassium jquivalent to Clavuianic acid 62.5 mg} 1000 Tablets "i) Cefadroxil monohydrate 267.622 gm 2) Potassium Clavulanate 75.943 gm A-3654 (:efixime for oral suspension 30 rnl bottle each 5 ml contains Gefixime Trihydrate squivalent to Gefixime 50 mg on anhydrous 1000 bottles CefiximeTrihydrate 352.0U0 gm 1 A-3655 1 Gefixime Tablets 200 mg (each tablet contains Gefixime Tridhydrate equivalent to frfiYimn ?nO mn anhydrous basis) 1000 Tab Gefixime Trihydrate 228.294 gm A-3656 A-3657 Cefpodoxime Proxetil Tablets 2UU mg teach tablet contains Cefpodoxime Proxetil equivalent to Gefoodoxime 200 mg) Geftriaxone and Sulbactam for injection. 1.5 gm (each vial containing Geftriaxone Sodium equivalent to Geftriaxone 1 gm and Salbactam Sodium equivalent to Salbactam 0 50 am) 1000 tablets 1000 vials Cefpodoxime Proxetil "m) Ceftrixone Sodium sterile 266.10 gm As per SION A- 407 2) Sulbactam Sodium sterile 604.44 gm A-3658 Cefuroxime Axetil Tablets 500 mg (each tablet contains Cefuroxime Axetil equivalent 1000 Cefuroxime Axem Tab gm A-3659 Cefuroxime for injection 750 mg (tach vidl contains Cefuroxime Sodium equivalent to 1000 Cefuroxime Sodium vials 867. f 4 gin A-3660 Cefuroxime for oral suspension 125 mg/ 5 ml in 60 ml bottles (each 5 ml containing Cefuroxime Axetil equivalent to Cefuroxime 1000 Cefuroxime Axetil bottles 1899 gm A-3661 Giticoline Injection 250 mg /ml (each vial contains Giticoline Sodium equivalent to 1000 Citicoline Sodium vials 287.39 gm A-3662 Giticoline Capsules 500 mg (each capsule contains citicoline sodium equivalent to 1000 Citicoline sodium capsules gm A-3663 Clopidogrel Tablets 75 mg (each tablet contains Clopidogrel Bisulphate equivalent to 1000 Clopidogrel Tablets Bisulphate 99.814 gm A-3664 -pS^ethyl Penicillin Potassium for oral suspension 250 mg/ 5 ml in 100 ml botUes (each 5 ml contains Phenoxy Methyl Penicillin Potassium equivalent to phenoxy 1000 Phenoxy Methyl bottles Penicillin Potassium 5o2U gm A-3665 Erythromycin Stearate for oral suspension 250 mg/5ml in 100 ml bottles (each 5 ml contains Etrythromycin Stearate equivalent to Erythromvcin 250 mq) 1000 Erythromycin bottles Stearate 7284 gm A-3666 Levofloxacin Tablets 500 mg (each tablet contains Levofloxacin Hemihydrate equivalent to Levofloxacin 500 mg or 1000 Levolfoxacin Tab Hemihydrate gm A-3667 Meropenem for injection l gm ( eacli vid contains MeropenemTrihydrate equivalent tc Meropenem Anhvdrous 1 am) 1000 MeropenemTrihydrs ) vials te l2oo gm A-3668 A-3669 1 A-367C Methyl Prednisolone Sodium Succinate to injection 500 mg {each vial containing Methy Prednisolone Sodium Succinate equivalen to Methyl Prednisolone 500 mg) Metronidazole oral suspension 200 mg/5 m in 100 ml bottles(each 5 ml suspensio contains Metronidazole Benzoate equivaler to 200 ma Metronidazole) ) Pefloxacin Tablet 400 mq (eacn labU r 1000 Methyl 1 vials Prednisolone t Sodium Succinate j 1000 Metronidazole n bottles Benzoate t »t 1000 1 Pefloxacin Mesvlat 729.3U gm 6753 gm s 569.731 CP >-

A-3671 A-3672 A-3673 contains Pefloxacin Mesylate equivalent to Pefloxacin 400 mg) Phenoxymethyl Peniciilin Potassium tabiets 500 mg. {each tablet contains Phenoxymethyl Peniciliin Potassium equivalent to Phenoxymethyi Penicillin 500 mg) -—. . ..— Piperaclliin and Tazobactam for injection 2.25 gm (each vial contains PiperacilIin Sodium equivaient to PiperacilIin 2 gms + Tazobactam Sodium equivalent to Tazobactam 0.25 gm) A-3674 A-3675 Primaquine Phosphate Tablets 2.5 mg (each tablet contains Primaquine Phophate eouivalent to Primaouine 2.5 mg) . .. / CUUiVOtwIK ' Iff —- Rosuvastatin 10 mg Tablets (each tablet contains Rosuvastatin Calcium equivalent to Rosuvastatin 10 mg) A-3676 SpecUnomycin injection 2 gm/viai (each yial contains Spectinomycin Hydrochioride eouivalent to Snectinomvcin 2 gm) ^nn mn Vancomycin Injection 500 mg (each yiai A-3677 contains Vancomycin Hydrochioride equivaient to Vancomycin 500 mg, vial size less than 10ml} Tab 1000 Tab Phenoxy Methyl Peniciilin Potassium 1000 Tablets 2) Tazobactam Sodium Primaquine Phosphate 1000 Tablets 1000 vials Amoxiciilin & Potassium Giavuianate for injection 1.2 g (each vial contains Amoxiciiiin Sodium equivalent to Amoxiciiiin 1000 mg and Potassium Giavuianate equivaient to Giavulanic Acid 200 mg) 1000 viais Rosuvastatin Calcium Spectinomycin Hydrochioride 1000 viais Vancomycin Hydrochioride Sterile mixture of Amoxiciiiin Trihydrate Potassium Giavuianate (5:1) gm 565.453 gm 295.0 gm 4.477 gm 10.625 gm 3278.00 gm 566.50 gm 1320 gm 2. Eff6ct of Public Notice:- SlONs of the above export products falling under the Chemicals and Allied Products Group are being notified. These are new entries. (Anup Wadhavan) Director Generai of Foreign Trade E-mail: dgft@nic.in (Issued from File No. 01/82/162/00198/AIVI-16/DES III)

;njection USP, 1 gm/10 ml via! each vial containing not less ban 1 gm of Cefotaxime) A407 Sterile Ceftriaxone Sodium BPAJSP Injection containing Ceftriaxone not less than 1 gm. 1000 Vials 1 Sterile Ceftriaxone Sodium BP/USP 1.160 kgs A408 Sterile Streptomycin Sulphate USP Injection 5 gms (containing not less than 5 gms of Streptomycin base) 1,00,000 Vos. 1 Streptomycin Sulphate Sterile 656.25 kgs A409 Sterlised Surgical Sutures (with/ Without Needles) 152 cms. USP (Catgut) 1 Dozen I Catgut Strand Unsterlised 152 cms. length Met to net. A410 Sulpha Methoxazole 1 kg 1 Methanol 2.000 kgs 2 Sodium Methoxide 0.520 kg 3 Diethyl Oxalate OR 1.350 kgs 3 a) Ethyl alcohol 3.000 kgs b) Oxalic Acid I.OOOkg 4 Hydroxyl Amine Sulphate 0.800 kg 5 Acetone 0.650 kg 6 Pyridine 0.100 kg 7 Acetanilide OR 1.10kg N-Acetyl Sulphanilyl Chloride (ASC) OR 1.20 kg Aniline 0.85 kg 8 Ethyl Acetate OR Methylene Chloride 1.00 kg 9 Sodium hydrosulphite 0.100 kg A411 Sustanon 250 Injection containing: i) Testosterone Propionate I.P. 30 mg. ii) Testosterone Phenyl Propionate BP 60 1 ml. ampule 1 Testosterone Propionate IP 33 mg. 2 Testosterone Phenyl Propionate BP 66 mg. 3 Testosterone Iso caproate BP 66 mg. mg.iii)Testosterone Iso Caproate 60 mg. iv) Testosterone Decanoate BP 100 mg 4 Testosterone Decanoate BP 110 mg. A412 Tablets/ capsules 1 kg content of relevant Bulk Drug 1 Relevant Bulk Drug/s 1.02 kg A413 Terbutaline Sulphate BP/USP (From 3,5 Dihydroxy Benzoic 1 kg I 3.5-Di-Hydroxy Benzoic Acid 2.27 kgs 2 D.M.F. 9.00 kgs Acid route) 3 Selenium dioxide 1.22 kg 4 Sodium Borohydride 0.15 kg 5 Tertiary Butyl amine 0.56 kg ^9

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