IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2015-12-30

DGFT Committee Minutes

Document text

Office of Directorate General of Foreign Trade
New Delhi -0

Para 4.7 Decision

Meeting No. 15/82/2015 of 2015-16, to consider the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products
and falling under Chapter 29 and 30, was scheduled for 30.12.2015 but actually held on 06.01.2016 under the Chairmanship of Dr. S.K. Bansal, Jt. DGFT in Room No.11, Udyog Bhawan, New Delhi.

Following members were present:-

Shri Nirmal Kumar, Dy.DGFT Shri A.K. Aggarwal, Addl. Indl. Advisor, DC&PC Shri D.N. Mathur, Consultant, Department of Pharmaceutical

The committee went through the minutes of earlier NC-III meeting No. 14/82 held on 16.12.2015 and approved the same.

Note:

In certain cases the decision of the Norms Committee refers to the Recommendations/ Observations / Deficiencies received from the concerned Technical authority in the same case or a different case of another firm with the same product. A scanned copy of such document is placed at the end of the Minutes. In some cases, the scanned copy uploaded may be unsigned. In both these instances, the scanned copy uploaded is to be accepted. The U.O.No. / O.M. No. of the scanned copy is reflected in the minutes.

MEETING NUMBER

: 15/82-ALC4/2015 MEETING DATE : 30.12.2015 1

Case No.:132/8/82-

ALC4/2014
Party Name:PROVENTUS LIFE SCIENCES PRIVATE LIMITED, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00796/AM15/
RLA File :04/24/040/00395/AM08/
Lic.No/Date:0410094357 12.03.2008 Defer Date:27.01.201 6 Decision : The Committee noted that information called for from the firm is awaited. The Committee decided to remind the firm to submit the requisite information at the earliest. In case requisite information is not received with in a period of 15 days case will be decided on the basis of available information.

Case No.:353/5/82-

ALC4/2015
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00493/AM16/
RLA File :03/95/040/00130/AM11/
Lic.No/Date:0310575673 24.05.2010 Defer Date:27.01.2016 Decision :The committee considered the case for ratification of norms under para 4.7 of HBP. The committee decided to defer the case for want of comments from DCPC.

Case No.:36/19/82-

ALC4/2014
Party Name:ALKALI METALS LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred

HQ File :01/82/050/01524/AM15/
RLA File :09/24/040/00503/AM12/
Lic.No/Date:0910052125 12.04.2012 Defer Date:27.01.2016 Decision : The committee considered the case for ratification of norms under para 4.7 of HBP. The committee decided to defer the case for want of comments from DCPC.

Case No.:38/19/82-

ALC4/2014
Party Name:PORUS LABORATORIES PVT LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01526/AM15/
RLA File :09/24/040/00050/AM13/
Lic.No/Date:0910052706 21.05.2012 Defer Date:27.01.2016 Decision : The committee considered the case for ratification of norms under para 4.7 of HBP. The committee decided to defer the case for want of comments from DCPC.

Case No.:18/19/82-

ALC4/2014
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01506/AM15/
RLA File :09/24/040/00085/AM13/
Lic.No/Date:0910052887 05.06.2012 Defer Date:27.01.2016 Decision : The committee decided to defer the case for want of DoP.

Case No.:33/20/82-

ALC4/2013
Party Name:CADILA HEALTHCARE LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01019/AM14/
RLA File :08/24/040/00097/AM13/
Lic.No/Date:0810112515 14.06.2012 Defer Date:27.01.2016 Decision : The Committee decided to defer the case for want of comments of DoP.

Case No.:173/5/82-

ALC4/2015
Party Name:FORACE POLYMERS (P) LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00313/AM16/
RLA File :05/23/040/00069/AM14/
Lic.No/Date:0510356983 13.06.2013 Defer Date:27.01.2016 Decision : The Committee decided to defer the case for want of comments of DCPC.

Case No.:9/30/83-ALC1/2013 Party Name:STERICON

PHARMA PVT.LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/83/050/00471/AM14/
RLA File :07/24/040/00152/AM14/
Lic.No/Date:0710097668 22.08.2013 Defer Date:27.01.2016 Decision : The Committee decided to send copy of application to DoP and deferred the case.

Case No.:140/23/82-

ALC4/2013
Party Name:UNITED PHOSPHORUS LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01187/AM14/
RLA File :03/95/040/00495/AM14/
Lic.No/Date:0310758627 21.11.2013 Defer Date:27.01.2016

Case No.:82/23/82-

ALC4/2013
Party Name:DEEPAK NITRITE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01129/AM14/
RLA File :34/24/040/00212/AM14/
Lic.No/Date:3410038711 12.12.2013 Defer Date:27.01.2016 Decision : The Committee decided to defer the case for want of comments of DCPC

Case No.:85/23/82-

ALC4/2013
Party Name:PARENTERAL DRUGS (INDIA) LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01132/AM14/
RLA File :56/24/040/00033/AM14/
Lic.No/Date:5610003400 20.12.2013 Defer Date:27.01.2016 Decision : The Committee decided to defer the case for want of comments of DoP

Case No.:45/3/82-ALC4/2014 Party Name:AKZO NOBEL

INDIA LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00049/AM15/
RLA File :02/24/040/00168/AM13/
Lic.No/Date:0210198458 03.01.2014 Defer Date: Decision :Already approved in 12/82 dated 18.11.2015.

Case No.:192/3/82-

ALC4/2014
Party Name:VIVIMED LABS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00196/AM15/
RLA File :09/24/040/00513/AM14/
Lic.No/Date:0910058896 10.01.2014 Defer Date:27.01.2016

Case No.:48/13/82-

ALC4/2015
Party Name:BELCHEM INDS. INDIA PVT. LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01011/AM16/
RLA File :03/94/040/00860/AM14/
Lic.No/Date:0310766718 17.01.2014 Defer Date:27.01.2016

Case No.:208/3/82-

ALC4/2014
Party Name:OGENE SYSTEMS INDIA PVT. LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00212/AM15/
RLA File :09/24/040/00515/AM14/
Lic.No/Date:0910059017 22.01.2014 Defer Date:27.01.2016 Decision : The Committee noted that information called for from the firm is awaited. The Committee accordingly decided await the reply and deferred the case.

Case No.:108/3/82-

ALC4/2014
Party Name:CROPNOSYS (INDIA) PRIVATE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred

HQ File :01/82/050/00112/AM15/
RLA File :03/94/040/00908/AM14/
Lic.No/Date:0310767733 24.01.2014 Defer Date:27.01.2016

Case No.:177/3/82-

ALC4/2014
Party Name:INDO AMINES LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00181/AM15/
RLA File :03/94/040/00958/AM14/
Lic.No/Date:0310768616 30.01.2014 Defer Date:27.01.2016 Decision : The Committee noted that information called for from the firm in NC meeting No.13/AM16 is awaited. The Committee accordingly decided await the reply and deferred the case.

Case No.:58/6/82-ALC4/2014 Party Name:BAYER

CROPSCIENCE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00460/AM15/
RLA File :03/94/040/00797/AM14/
Lic.No/Date:0310772503 28.02.2014 Defer Date:27.01.2016

Case No.:106/3/82-

ALC4/2014
Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00110/AM15/
RLA File :03/95/040/00960/AM14/
Lic.No/Date:0310772411 28.02.2014 Defer Date:27.01.2016

Case No.:34/6/82-ALC4/2014 Party Name:INDOCO

REMEDIES LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00436/AM15/
RLA File :03/94/040/00973/AM14/
Lic.No/Date:0310773112 05.03.2014 Defer Date:27.01.2016 Decision : The Committee noted that requisite information has been received and sent to DoP on 11.12.2015. The Committee accordingly decided to defer the case for want of comments of DoP.

Case No.:58/4/82-ALC4/2014 Party Name:IND-SWIFT

LABORATORIES LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00306/AM15/
RLA File :22/24/040/00100/AM14/
Lic.No/Date:2210014694 14.03.2014 Defer Date:27.01.2016 Committee accordingly decided to await the reply and deferred the case.

Case No.:57/3/82-ALC4/2014 Party Name:JUBILANT LIFE

SCIENCES LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00061/AM15/
RLA File :05/23/040/00506/AM14/
Lic.No/Date:0510382053 18.03.2014 Defer Date:27.01.2016

Case No.:51/5/82-ALC4/2014 Party Name:JINDAL DRUGS

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00368/AM15/
RLA File :03/94/040/01098/AM14/
Lic.No/Date:0310776087 27.03.2014 Defer Date:27.01.2016

Case No.:51/6/82-ALC4/2014 Party Name:PERFECT

INDUSTRIES PRIVATE LIMITED. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00453/AM15/
RLA File :03/95/040/01054/AM14/
Lic.No/Date:0310776759 02.04.2014 Defer Date:27.01.2016

Case No.:50/6/82-ALC4/2014 Party Name:V & V PHARMA

INDUSTRIES Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00452/AM15/
RLA File :03/95/040/01061/AM14/
Lic.No/Date:0310776760 02.04.2014 Defer Date:27.01.2016

Case No.:1/13/85-ALC3/2014 Party Name:RA CHEM

PHARMA LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/85/050/00104/AM15/
RLA File :09/24/040/00007/AM15/
Lic.No/Date:0910059734 08.04.2014 Defer Date: Decision : Already approved in12/82 dated 18.11.2015.

Case No.:20/6/82-ALC4/2014 Party Name:ADISHANK

CHEMICALS PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00422/AM15/
RLA File :03/94/040/01140/AM14/
Lic.No/Date:0310777786 09.04.2014 Defer Date:27.01.2016

Case No.:1/2/82-ALC4/2014 Party Name:CADILA

HEALTHCARE LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00003/AM15/
RLA File :08/24/040/00008/AM15/
Lic.No/Date:0810130534 11.04.2014 Defer Date:27.01.2016

Decision : The Committee decided to send copy of application to DoP and decided to defer the case.

Case No.:32/5/82-ALC4/2014 Party Name:EMCURE

PHARMACEUTICALS LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00349/AM15/
RLA File :31/83/040/00008/AM15/
Lic.No/Date:3110063481 11.04.2014 Defer Date:30.12.2015 Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/409/2014-PI(Norms) dated January 2015 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No.:49/13/82-

ALC4/2015
Party Name:BELCHEM INDS. INDIA PVT. LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01012/AM16/
RLA File :03/94/040/01118/AM14/
Lic.No/Date:0310779215 23.04.2014 Defer Date:27.01.2016

Case No.:183/6/82-

ALC4/2014
Party Name:TIDE INDUSTRIES Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00585/AM15/
RLA File :34/24/040/00005/AM15/
Lic.No/Date:3410039854 23.04.2014 Defer Date:27.01.2016

Case No.:53/5/82-ALC4/2014 Party Name:UNIMAX

CHEMICALS PVT LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00370/AM15/
RLA File :03/95/040/00015/AM15/
Lic.No/Date:0310779156 23.04.2014 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/437/2014-PI(Norms) dated Feb. 2015 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No.:51/10/82-

ALC4/2014
Party Name:VIVIMED LABS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Deffered and Re-indexed HQ File :01/82/050/00965/AM15/
RLA File :09/24/040/00039/AM15/
Lic.No/Date:0910059887 28.04.2014 Defer Date:30.12.2015

Case No.:61/10/82-

ALC4/2014
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00975/AM15/
RLA File :03/95/040/00913/AM14/
Lic.No/Date:0310779831 29.04.2014 Defer Date:27.01.2016

Case No.:237/6/82-

ALC4/2014
Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00639/AM15/
RLA File :17/24/040/00002/AM15/
Lic.No/Date:1710005803 05.05.2014 Defer Date:27.01.2016

Case No.:9/10/82-ALC4/2014 Party Name:EMCURE

PHARMACEUTICALS LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00923/AM15/
RLA File :31/83/040/00032/AM15/
Lic.No/Date:3110064004 21.05.2014 Defer Date: Decision : Already approved in 12/82 meeting dated 18.11.2015.

Case No.:44/13/82-ALC4/2015 Party Name:ATUL

BIOSCIENCE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01007/AM16/
RLA File :52/24/040/00004/AM15/
Lic.No/Date:5210041063 23.05.2014 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide O.M. No.U.O.No.14010/16/2015-Ch-II dated 15.12.2015 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No.:13/2/82-ALC4/2015 Party Name:JUBILANT LIFE

SCIENCES LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00028/AM16/
RLA File :05/23/040/00080/AM15/
Lic.No/Date:0510387607 28.05.2014 Defer Date:27.01.2016

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

Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00702/AM15/
RLA File :09/24/040/00108/AM15/
Lic.No/Date:0910060258 28.05.2014 Defer Date:27.01.2016

Case No.:1/3/82-ALC4/2015

Party Name: BALAJI AMINES LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status: Case Approved

HQ File :01/82/050/00031/AM16/
RLA File :31/83/040/00006/AM15/
Lic.No/Date:3110064305 05.06.2014 Defer Date: Decision : Already approved in 12/82 meeting dated 18.11.2015.

Case No.:165/6/82-

ALC4/2014
Party Name:HALDIA PETROCHEMICALS LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00567/AM15/
RLA File :02/24/040/00037/AM15/
Lic.No/Date:0210203844 05.06.2014 Defer Date:27.01.2016

Case No.:106/8/82-

ALC4/2014
Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00770/AM15/
RLA File :03/94/040/00131/AM15/
Lic.No/Date:0310785223 12.06.2014 Defer Date:27.01.2016

Case No.:60/10/82-

ALC4/2014
Party Name:BIO-TECH OPHTHALMICS PVT. LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00974/AM15/
RLA File :08/24/040/00116/AM15/
Lic.No/Date:0810132332 13.06.2014 Defer Date:27.01.2016 Committee accordingly decided await the reply and deferred the case

Case No.:77/8/82-ALC4/2014 Party Name:BENZO CHEM

INDUSTRIES PRIVATE LIMITED, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00741/AM15/
RLA File :03/94/040/00196/AM15/
Lic.No/Date:0310785501 17.06.2014 Defer Date:27.01.2016

Case No.:20/8/82-ALC4/2014 Party Name:SRINI

PHARMACEUTICALS LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00684/AM15/
RLA File :09/24/040/00139/AM15/
Lic.No/Date:0910060467 17.06.2014 Defer Date:27.01.2016 Committee accordingly decided await the reply and deferred the case

Case No.:19/8/82-ALC4/2014 Party Name:HETERO LABS

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00683/AM15/
RLA File :09/24/040/00153/AM15/
Lic.No/Date:0910060486 18.06.2014 Defer Date:27.01.2016

Committee accordingly decided await the reply and deferred the case

Case No.:52/8/82-ALC4/2014 Party Name:LAKE

CHEMICALS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00716/AM15/
RLA File :07/24/040/00096/AM15/
Lic.No/Date:0710105418 26.06.2014 Defer Date:27.01.2016 Decision : The Committee considered the case for ratification of Norms and decided send a copy of application to DoP.

Case No.:202/6/82-

ALC4/2014
Party Name:FORACE POLYMERS (P) LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00604/AM15/
RLA File :05/23/040/00139/AM15/
Lic.No/Date:0510389232 01.07.2014 Defer Date:27.01.2016

Case No.:62/10/82-

ALC4/2014
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00976/AM15/
RLA File :03/95/040/00271/AM15/
Lic.No/Date:0310786523 08.07.2014 Defer Date:27.01.2016

Case No.:44/15/82-

ALC4/2014
Party Name:HETERO LABS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01331/AM15/
RLA File :09/24/040/00192/AM15/
Lic.No/Date:0910060635 09.07.2014 Defer Date:27.01.2016 Committee accordingly decided await the reply and deferred the case

Case No.:72/10/82-

ALC4/2014
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00986/AM15/
RLA File :07/24/040/00112/AM15/
Lic.No/Date:0710105884 18.07.2014 Defer Date:27.01.2016

Case No.:25/15/82-

ALC4/2014
Party Name:SHIVAM OILS & PROTEINS INDUSTRY, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01312/AM15/
RLA File :56/24/040/00019/AM15/
Lic.No/Date:5610004338 22.07.2014 Defer Date:27.01.2016 Committee accordingly decided await the reply and deferred the case

Case No.:21/9/82-ALC4/2014 Party Name:PI INDUSTRIES

LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00818/AM15/
RLA File :13/24/040/00020/AM15/
Lic.No/Date:1310047575 12.08.2014 Defer Date:27.01.2016

Case No.:37/7/82-ALC4/2015 Party Name:DR J

PHARMACHEM (INDIA)(PROP.ADITYA PRAMOD JOGDEO) Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00642/AM16/
RLA File :31/83/040/00125/AM15/
Lic.No/Date:3110064792 28.08.2014 Defer Date:27.01.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. 35011/592/2015-PI(Norms) dated 11.12.2015, uploaded along with these minutes decided to send a copy of application to DCPC and deferred the case.

Case No.:254/13/82-

ALC4/2014
Party Name:SEQUENT SCIENTIFIC LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01257/AM15/
RLA File :03/95/040/00459/AM15/
Lic.No/Date:0310788513 28.08.2014 Defer Date:27.01.2016 Committee accordingly decided await the reply and deferred the case

Case No.:217/13/82-

ALC4/2014
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01220/AM15/
RLA File :03/94/040/00494/AM15/
Lic.No/Date:0310788620 02.09.2014 Defer Date:27.01.2016 Decision : Committee observed that in this case, fraudulent CA certificates appear to have been furnished and the matter is under consideration for initiation of appropriate proceedings. It was not possible to decide the case and it was deferred.

Case No.:22/13/82-ALC4/2014 Party Name:MANGALAM

ORGANICS LIMITED (FORMERLY DUJODWALA Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01025/AM15/
RLA File :03/95/040/00379/AM15/
Lic.No/Date:0310788810 05.09.2014 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide O.M. No.U.O.No.14010/14/2015-Ch-II dated 15.12.2015 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA

Case No.:4/8/82-ALC4/2014 Party Name:HONOUR LAB

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File RLA File Lic.No/Date:0910060963 Defer

:01/82/050/00668/AM15/
:09/24/040/00318/AM15/
12.09.2014 Date:27.01.2016 Decision: Requisite information called for from the firm has been received and forwarded to DoP. The Committee decided to defer the case for want of comments of DoP.

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

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00670/AM15/
RLA File :09/24/040/00314/AM15/
Lic.No/Date:0910060964 12.09.2014 Defer Date:27.01.2016 Decision : Requisite information called for from the firm has been received and forwarded to DoP. The Committee decided to defer the case for want of comments of DoP.

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

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00672/AM15/
RLA File :09/24/040/00315/AM15/
Lic.No/Date:0910060966 12.09.2014 Defer Date:27.01.2016 Decision : Requisite information called for from the firm has been received and forwarded to DoP. The Committee decided to defer the case for want of comments of DoP.

Case No.:28/13/82-

ALC4/2014
Party Name:TITAN LABORATORIES PVT. LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01031/AM15/
RLA File :03/95/040/00398/AM15/
Lic.No/Date:0310789099 12.09.2014 Defer Date:27.01.2016

Case No.:188/13/82-

ALC4/2014
Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01191/AM15/
RLA File :03/94/040/00102/AM15/
Lic.No/Date:0310789322 17.09.2014 Defer Date:27.01.2016

Case No.:57/13/82-

ALC4/2014
Party Name:HELLO PAINTS (P) LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01060/AM15/
RLA File :05/23/040/00277/AM15/
Lic.No/Date:0510391246 19.09.2014 Defer Date:27.01.2016

Case No.:125/8/82-ALC4/2014 Party Name:HETERO DRUGS

LIMITED, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case: deferred HQ File :01/82/050/00789/AM15/
RLA File :09/24/040/00345/AM15/
Lic.No/Date:0910061000 19.09.2014 Defer Date: 27.01.2016 Decision : The Committee noted that information called for from the firm is awaited. The

Case No.:9/15/82-ALC4/2014 Party Name:VIRCHOW

BIOTECH PV T LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01296/AM15/
RLA File :09/24/040/00327/AM15/
Lic.No/Date:0910061001 19.09.2014 Defer Date:27.01.2016 Decision : The Committee decided to defer the case for want of comments of DBT.

Case No.:60/15/82-

ALC4/2014
Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01347/AM15/
RLA File :31/83/040/00136/AM15/
Lic.No/Date:3110064915 22.09.2014 Defer Date:27.01.2016

Case No.:128/8/82-ALC4/2014 Party Name:HETERO LABS

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Rejected HQ File :01/82/050/00792/AM15/
RLA File :09/24/040/00341/AM15/
Lic.No/Date:0910061003 22.09.2014 Defer Date: Decision : The Committee noted that export item and import item are chemically same.
Accordingly, the committee decided to reject the case. Committee noted that the applicant appears to have attempted to mislead it. RA concerned may take further necessary action as per decision of NC.

Case No.:129/8/82-ALC4/2014 Party Name:HETERO LABS

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Rejected HQ File :01/82/050/00793/AM15/
RLA File :09/24/040/00338/AM15/
Lic.No/Date:0910061004 22.09.2014 Defer Date: Decision : The Committee noted that export item and import item are chemically same. The committee decided to reject the case. Committee noted that the applicant appears to have attempted to mislead it. RA concerned may take further necessary action as per decision of NC.

Case No.:17/13/82-

ALC4/2014
Party Name:GRASIM INDUSTRIES LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01020/AM15/
RLA File :34/24/040/00155/AM15/
Lic.No/Date:3410040570 23.09.2014 Defer Date:27.01.2016

Case No.:115/13/82-

ALC4/2014
Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01118/AM15/
RLA File :02/24/040/00097/AM15/
Lic.No/Date:0210205008 23.09.2014 Defer Date:27.01.2016

Case No.:74/13/82-

ALC4/2014
Party Name:CONSTECH ENTERPRISES PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01077/AM15/
RLA File :05/23/040/00282/AM15/
Lic.No/Date:0510391308 24.09.2014 Defer Date:27.01.2016

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

GENERICS LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00024/AM16/
RLA File :05/23/040/00261/AM15/
Lic.No/Date:0510391358 26.09.2014 Defer Date:27.01.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. 35011/294/2015-PI(Norms) dated Oct.2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

Case No.:21/13/82-

ALC4/2014
Party Name:JUBILANT GENERICS LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01024/AM15/
RLA File :05/23/040/00260/AM15/
Lic.No/Date:0510391357 26.09.2014 Defer Date:27.01.2016

Case No.:19/13/82-

ALC4/2014
Party Name:SANO MEDICAL KITS PVT. LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01022/AM15/
RLA File :04/24/040/00171/AM15/
Lic.No/Date:0410159504 29.09.2014 Defer Date:27.01.2016

Case No.:177/13/82-

ALC4/2014
Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01180/AM15/
RLA File :03/94/040/00586/AM15/
Lic.No/Date:0310789849 30.09.2014 Defer Date:27.01.2016

Case No.:15/13/82-

ALC4/2014
Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01018/AM15/
RLA File :34/24/040/00161/AM15/
Lic.No/Date:3410040594 30.09.2014 Defer Date:27.01.2016

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

AROMATICS PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01545/AM15/
RLA File :03/94/040/00594/AM15/
Lic.No/Date:0310789922 01.10.2014 Defer Date:27.01.2016

Case No.:77/13/82-

ALC4/2014
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01080/AM15/
RLA File :04/24/040/00164/AM15/
Lic.No/Date:0410159520 01.10.2014 Defer Date:27.01.2016

Case No.:160/13/82-

ALC4/2014
Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01163/AM15/
RLA File :03/94/040/00544/AM15/
Lic.No/Date:0310789976 07.10.2014 Defer Date:27.01.2016

Case No.:176/13/82-

ALC4/2014
Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01179/AM15/
RLA File :03/94/040/00361/AM15/
Lic.No/Date:0310789985 07.10.2014 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/114/2015-PI(Norms) dated Sept. 2015 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

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

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00802/AM15/
RLA File :09/24/040/00362/AM15/
Lic.No/Date:0910061060 07.10.2014 Defer Date:27.01.2016

Case No.:35/13/82-

ALC4/2014
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01038/AM15/
RLA File :05/23/040/00218/AM15/
Lic.No/Date:0510391491 08.10.2014 Defer Date:27.01.2016

Case No.:76/13/82-

ALC4/2014
Party Name:CAPLIN POINT LABORATORIES LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01079/AM15/
RLA File :04/24/040/00163/AM15/
Lic.No/Date:0410159566 13.10.2014 Defer Date:27.01.2016

Case No.:184/13/82-

ALC4/2014
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01187/AM15/
RLA File :03/94/040/00675/AM15/
Lic.No/Date:0310790237 14.10.2014 Defer Date:27.01.2016

Case No.:114/9/82-

ALC4/2014
Party Name:HONOUR LAB LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00911/AM15/
RLA File :09/24/040/00386/AM15/
Lic.No/Date:0910061094 15.10.2014 Defer Date:27.01.2016 Decision : Requisite information has been received and sent to DoP. The committee decided to defer the case for want of comments of DoP.

Case No.:42/15/82-

ALC4/2014
Party Name:PVS AGRO VET Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01329/AM15/
RLA File :09/24/040/00246/AM15/
Lic.No/Date:0910061105 16.10.2014 Defer Date:27.01.2016

Case No.:154/13/82-

ALC4/2014
Party Name:GEM AROMATICS PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Deffered and Re-indexed HQ File :01/82/050/01157/AM15/
RLA File :03/94/040/00680/AM15/
Lic.No/Date:0310790351 17.10.2014 Defer Date:30.12.2015

Case No.:78/10/82-

ALC4/2014
LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Rjected HQ File :01/82/050/00992/AM15/
RLA File :09/24/040/00393/AM15/
Lic.No/Date:0910061130 22.10.2014 Defer Date: Decision : The Committee noted that export item and import item are chemically same. Accordingly, the committee decided to reject the case. Committee noted that the applicant appears to have attempted to mislead it. RA concerned may take further necessary action as per decision of NC.

Case No.:80/10/82-ALC4/2014 Party Name:HETERO LABS

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Rejected HQ File :01/82/050/00994/AM15/
RLA File :09/24/040/00394/AM15/
Lic.No/Date:0910061132 22.10.2014 Defer Date: Decision : The Committee noted that export item and import item are chemically same. Accordingly, the committee decided to reject the case. Committee noted that the applicant appears to have attempted to mislead it. RA concerned may take further necessary action as per decision of NC.

Case No.:81/10/82-

ALC4/2014
Party Name:HONOUR LAB LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00995/AM15/
RLA File :09/24/040/00407/AM15/
Lic.No/Date:0910061133 22.10.2014 Defer Date:27.01.2016

Case No.:172/13/82-

ALC4/2014
Party Name:PRASOL CHEMICALS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01175/AM15/
RLA File :03/95/040/00362/AM15/
Lic.No/Date:0310790480 22.10.2014 Defer Date:27.01.2016 Decision : The Committee decided to defer the case for want of comments of DC&PC

Case No.:110/13/82-

ALC4/2014
Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01113/AM15/
RLA File :34/24/040/00188/AM15/
Lic.No/Date:3410040635 22.10.2014 Defer Date:27.01.2016

93 Case No.:83/10/82-ALC4/2014 Party Name:HETERO LABS LIMITED Meet No/Date:15/82- ALC4/2015 Status:Case Approved

30.12.2015 HQ File :01/82/050/00997/AM15/
RLA File :09/24/040/00402/AM15/
Lic.No/Date:0910061139 27.10.2014 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/547/2015-PI(Norms) dt. December 2015, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No.:86/10/82-

ALC4/2014
Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01000/AM15/
RLA File :34/24/040/00194/AM15/
Lic.No/Date:3410040644 30.10.2014 Defer Date:27.01.2016 Decision : The Committee decided to defer the case for want of comments of DC&PC.

Case No.:104/13/82-

ALC4/2014
Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01107/AM15/
RLA File :13/24/040/00029/AM15/
Lic.No/Date:1310047687 05.11.2014 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Parmaceuticals forwarded vide O.M. No.35011/375/2015-PI(Norms) dated 11.12.2015 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No.:266/13/82-

ALC4/2014
Party Name:ATUL LIMITED, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01269/AM15/
RLA File :08/24/040/00289/AM15/
Lic.No/Date:0810133735 05.11.2014 Defer Date:27.01.2016

Case No.:268/13/82-

ALC4/2014
Party Name:ATUL LIMITED, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01271/AM15/
RLA File :08/24/040/00283/AM15/
Lic.No/Date:0810133734 05.11.2014 Defer Date:27.01.2016

Case No.:39/7/82-ALC4/2015 Party Name:MYLAN

Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00644/AM16/
RLA File :09/24/040/00371/AM15/
Lic.No/Date:0910061181 05.11.2014 Defer Date:27.01.2016

Case No.:107/13/82-

ALC4/2014
Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01110/AM15/
RLA File :34/24/040/00196/AM15/
Lic.No/Date:3410040655 05.11.2014 Defer Date:27.01.2016 Decision : The Committee based on the written comments forwarded by the D/o C&PC, letter No.14010/164/2011-C-II dated 5.1.2016 , uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

100

Case No.:23/15/82-ALC4/2014 Party Name:VENUS

REMEDIES LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01310/AM15/
RLA File :22/24/040/00065/AM15/
Lic.No/Date:2210015115 07.11.2014 Defer Date: 27.01.2016

101

Case No.:114/13/82-

ALC4/2014
Party Name:VIRDEV INTERMEDIATES PVT LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01117/AM15/
RLA File :52/24/040/00042/AM15/
Lic.No/Date:5210041292 10.11.2014 Defer Date:27.01.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. 35011/92/2015-PI(Norms) dated Sept.2015 , uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

102

Case No.:111/13/82-

ALC4/2014
Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01114/AM15/
RLA File :05/23/040/00352/AM15/
Lic.No/Date:0510391927 11.11.2014 Defer Date:27.01.2016 Decision :Information called for from the firm is received and sent to AYUSH on 8.1.2016.

103

Case No.:19/15/82-ALC4/2014 Party Name:MALLADI

DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01306/AM15/
RLA File :04/24/040/00206/AM15/
Lic.No/Date:0410159706 11.11.2014 Defer Date:

D/o Pharmaceuticals forwarded vide O.M. No. 35011/425/2015-PI(Norms) dated December 2015, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

104

Case No.:20/15/82-ALC4/2014 Party Name:MALLADI

DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01307/AM15/
RLA File :04/24/040/00207/AM15/
Lic.No/Date:0410159705 11.11.2014 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No. 35011/214/2015-PI(Norms) dated decision of NC.

105

Case No.:61/18/82-

ALC4/2014
Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01427/AM15/
RLA File :34/24/040/00198/AM15/
Lic.No/Date:3410040676 11.11.2014 Defer Date:27.01.2016

106

Case No.:100/4/82-

ALC4/2015
Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00139/AM16/
RLA File :17/24/040/00125/AM15/
Lic.No/Date:1710005978 12.11.2014 Defer Date:27.01.2016

107

Case No.:120/13/82-

ALC4/2014
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01123/AM15/
RLA File :05/23/040/00325/AM15/
Lic.No/Date:0510391947 12.11.2014 Defer Date:27.01.2016

108

Case No.:77/18/82-

ALC4/2014
Party Name:LAKELAND CHEMICALS (INDIA) LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01443/AM15/
RLA File :03/95/040/00629/AM14/
Lic.No/Date:0310790966 12.11.2014 Defer Date:27.01.2016

Decision : The Committee based on the written comments forwarded by the D/o C&PC vide U.O.No.14010/8/2011-CH-II dated 7.1.2016 , uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

109

Case No.:65/18/82-

ALC4/2014
Party Name:DEEPAK NITRITE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01431/AM15/
RLA File :34/24/040/00199/AM15/
Lic.No/Date:3410040677 13.11.2014 Defer Date:27.01.2016 Decision : The Committee noted that information called for from the firm is awaited. The Committee accordingly decided await the reply and deferred the case.

110

Case No.:72/18/82-

ALC4/2014
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01438/AM15/
RLA File :03/94/040/00773/AM15/
Lic.No/Date:0310791044 13.11.2014 Defer Date:30.12.2015 Decision : Requisite information has been received and sent to DOP on 8.1.2016.

111

Case No.:42/18/82-

ALC4/2014
Party Name:LAKELAND CHEMICALS (INDIA) LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01408/AM15/
RLA File :03/95/040/00628/AM14/
Lic.No/Date:0310791049 13.11.2014 Defer Date:27.01.2016 Decision : The Committee based on the written comments forwarded by the D/o C&PC vide U.O.No.14010/8/2011-CH-II dated 7.1.2016 , uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

112

Case No.:65/15/82-

ALC4/2014
Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01352/AM15/
RLA File :05/23/040/00360/AM15/
Lic.No/Date:0510392011 14.11.2014 Defer Date:30.12.2015 Decision :Requisite information received and sent to AYUSH on 8.1.2016. Comments are awaited from D/o Ayush.

113

Case No.:119/13/82-

ALC4/2014
Party Name:JUBILANT GENERICS LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01122/AM15/
RLA File :05/23/040/00304/AM15/
Lic.No/Date:0510392008 14.11.2014 Defer Date:27.01.2016

114

Case No.:34/18/82-ALC4/2014 Party Name:ENCUBE

ETHICALS PVT LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01400/AM15/
RLA File :03/94/040/00803/AM15/
Lic.No/Date:0310791303 21.11.2014 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/130/2015-PI(Norms) dated 11.09.2015 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of

115

Case No.:16/18/82-

ALC4/2014
Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01382/AM15/
RLA File :03/94/040/00789/AM15/
Lic.No/Date:0310791300 21.11.2014 Defer Date:27.01.2016 Decision : The Committee decided to defer the case for want of comments of DC&PC.

116

Case No.:74/18/82-

ALC4/2014
Party Name:ADESHWAR MEDITEX PVT. LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01440/AM15/
RLA File :03/94/040/00814/AM15/
Lic.No/Date:0310791373 25.11.2014 Defer Date:27.01.2016

117

Case No.:18/18/82-

ALC4/2014
Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01384/AM15/
RLA File :03/94/040/00792/AM15/
Lic.No/Date:0310791374 25.11.2014 Defer Date:27.01.2016

118

Case No.:15/2/82-ALC4/2015 Party Name:SHALINA

LABORATORIES PVT. LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00030/AM16/
RLA File :03/95/040/00639/AM15/
Lic.No/Date:0310791416 25.11.2014 Defer Date:27.01.2016

119

Case No.:43/18/82-

ALC4/2014
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01409/AM15/
RLA File :03/95/040/00701/AM15/
Lic.No/Date:0310791419 26.11.2014 Defer Date:30.12.2015

120

Case No.:10/2/82-ALC4/2015 Party Name:JUBILANT

GENERICS LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00025/AM16/
RLA File :05/23/040/00211/AM15/
Lic.No/Date:0510392167 27.11.2014 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/326/2015-PI(Norms) dated November 2015 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

121

Case No.:11/2/82-ALC4/2015 Party Name:JUBILANT

GENERICS LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00026/AM16/
RLA File :05/23/040/00370/AM15/
Lic.No/Date:0510392171 27.11.2014 Defer Date:27.01.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals O.M.No.35011/503/2015-PI(Norms) dated 28.12.2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

122

Case No.:114/18/82-

ALC4/2014
Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01480/AM15/
RLA File :22/24/040/00073/AM15/
Lic.No/Date:2210015135 28.11.2014 Defer Date:27.01.2016

123

Case No.:26/18/82-

ALC4/2014
Party Name:SADHANA NITRO CHEM LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01392/AM15/
RLA File :03/95/040/00714/AM15/
Lic.No/Date:0310791516 28.11.2014 Defer Date:27.01.2016

124

Case No.:92/18/82-

ALC4/2014
Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred

HQ File :01/82/050/01458/AM15/
RLA File :34/24/040/00224/AM15/
Lic.No/Date:3410040732 28.11.2014 Defer Date:27.01.2016 Decision : The Committee decided to defer the case for want of comments of DC&PC.

125

Case No.:82/18/82-

ALC4/2014
Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01448/AM15/
RLA File :05/23/040/00413/AM15/
Lic.No/Date:0510392368 10.12.2014 Defer Date:27.01.2016 Decision :Requisite information has been received and sent to AYUSH on 8.1.2016

126

Case No.:101/4/82-

ALC4/2015
Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00140/AM16/
RLA File :17/24/040/00144/AM15/
Lic.No/Date:1710005998 10.12.2014 Defer Date:27.01.2016

127

Case No.:97/18/82-

ALC4/2014
Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01463/AM15/
RLA File :30/24/040/00041/AM15/
Lic.No/Date:3010103261 11.12.2014 Defer Date:27.01.2016

128

Case No.:119/18/82-

ALC4/2014
Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01485/AM15/
RLA File :05/24/040/00419/AM15/
Lic.No/Date:0510392414 15.12.2014 Defer Date:27.01.2016

129

Case No.:118/18/82-

ALC4/2014
Party Name:H.J.AROCHEM PVT. LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Rejected HQ File :01/82/050/01484/AM15/
RLA File :08/24/040/00341/AM15/
Lic.No/Date:0810134067 16.12.2014 Defer Date:
Decision : The Committee noted that information has been called for from the firm by NC in its meeting No.7/82 dated 24.07.2015 but reply has not been received so far. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC.

130

Case No.:143/5/82-

ALC4/2015
Party Name:FDC LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00283/AM16/
RLA File :03/94/040/00834/AM15/
Lic.No/Date:0310792175 19.12.2014 Defer Date:27.01.2016 Decision : The Committee decided to defer the case for want of comments of DoP.

131

Case No.:91/18/82-

ALC4/2014
Party Name:ALCHEM INTERNATIONAL LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Deffered HQ File :01/82/050/01457/AM15/
RLA File :05/23/040/00449/AM15/
Lic.No/Date:0510392602 29.12.2014 Defer Date:27.01.2016 Decision : The Committee noted that information called for is awaited.

132

Case No.:84/18/82-

ALC4/2014
Party Name:HESTER BIOSCIENCES LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01450/AM15/
RLA File :08/24/040/00362/AM15/
Lic.No/Date:0810134170 30.12.2014 Defer Date:27.01.2016

133

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

PHARMACEUTICALS LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00003/AM16/
RLA File :05/23/040/00450/AM15/
Lic.No/Date:0510392649 01.01.2015 Defer Date:27.01.2016

134

Case No.:29/15/82-

ALC4/2014
Party Name:HONOUR LAB LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01316/AM15/
RLA File :09/24/040/00543/AM15/
Lic.No/Date:0910061501 07.01.2015 Defer Date:27.01.2016

135

Case No.:96/18/82-

ALC4/2014
Party Name:NUTRA SPECIALITIES PVT. LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01462/AM15/
RLA File :04/24/040/00248/AM15/
Lic.No/Date:0410159986 07.01.2015 Defer Date:27.01.2016 Decision : The Committee based on the written comments forwarded by the D/o

Pharmaceuticals vide O.M. No.35011/135/2015-PI(Norms) dated July, 2015 , uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

136

Case No.:92/7/82-ALC4/2015 Party Name:RIDDHI

PHARMA Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Rejected HQ File :01/82/050/00697/AM16/
RLA File :34/24/040/00266/AM15/
Lic.No/Date:3410040864 12.01.2015 Defer Date: Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. 35011/567/2015-PI(Norms) dated 21.12.2015, uploaded along with these minutes decided to reject the case. RA concerned may take further

137

Case No.:92/5/82-ALC4/2015 Party Name:ALKALOIDS

CORPORATION Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00232/AM16/
RLA File :02/24/040/00203/AM15/
Lic.No/Date:0210205448 14.01.2015 Defer Date:27.01.2016 Decision : The Committee decided to defer the case for want of comments of DOP.

138

Case No.:110/5/82-ALC4/2015 Party Name:UNIMAX

CHEMICALS PVT LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved
HQ File :01/82/050/00250/AM16/
RLA File :03/95/040/00811/AM15/
Lic.No/Date:0310793038 19.01.2015 Defer Date: Decision : This case was rejected by NC in its meeting No.13/AM16 as per recommendation of DoP forwarded vide O.M. No. 35011/315/2014-PI (norms) dated 30.09.2015.

The Committee has reconsidered this case under para 4.7 of HBP. In view of the fact noticed by DoP regarding contradictory production consumption data submitted by the firm, it was decided to allow the case without any wastage.

RA concerned may take further necessary action as per decision of NC.

139

Case No.:112/5/82-ALC4/2015 Party Name:UNIMAX

CHEMICALS PVT LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00252/AM16/
RLA File :03/95/040/00812/AM15/
Lic.No/Date:0310793039 19.01.2015 Defer Date: 25.02.2016 Decision : This case was rejected by NC in its meeting No.13/AM16. The Committee has reconsidered this case and decided to defer for want of comments of DOP.

140

Case No.:11/16/82-

ALC4/2014
Party Name:DR REDDYS Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File RLA File Lic.No/Date:0910061549 Defer

:01/82/050/01363/AM15/
:09/24/040/00580/AM15/
21.01.2015 Date:27.01.2016

141

Case No.:12/16/82-

ALC4/2014
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01364/AM15/
RLA File :09/24/040/00592/AM15/
Lic.No/Date:0910061552 21.01.2015 Defer Date:27.01.2016

142

Case No.:86/5/82-ALC4/2015 Party Name:SENTISS

PHARMA PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00226/AM16/
RLA File :05/24/040/00489/AM15/
Lic.No/Date:0510392966 22.01.2015 Defer Date:27.01.2016

143

Case No.:1/18/82-ALC4/2014 Party Name:JODAS EXPOIM

PVT.LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01367/AM15/
RLA File :09/24/040/00601/AM15/
Lic.No/Date:0910061562 27.01.2015 Defer Date:27.01.2016

144

Case No.:31/7/82-ALC4/2015 Party Name:V.D.H.

ORGANICS PVT. LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00636/AM16/
RLA File :05/24/040/00498/AM15/
Lic.No/Date:0510392987 27.01.2015 Defer Date:27.01.2016

145

Case No.:32/7/82-ALC4/2015 Party Name:V.D.H.

ORGANICS PVT. LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00637/AM16/
RLA File :05/24/040/00499/AM15/
Lic.No/Date:0510392988 27.01.2015 Defer Date:27.01.2016 Decision : The Committee based on the written comments forwarded by the D/o C&PC letter No.14010/50/2010-C-II dated 30.12.2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

146 Case No.:25/7/82-ALC4/2015 Party Name:DEEPAK Meet No/Date:15/82- Status:Case

NOVOCHEM TECHNOLOGIES LTD ALC4/2015 30.12.2015 Deferred HQ File :01/82/050/00630/AM16/
RLA File :31/83/040/00144/AM15/
Lic.No/Date:3110065235 28.01.2015 Defer Date:27.01.2016

147

Case No.:230/5/82-

ALC4/2015
Party Name:R.K.INDUSTRIES, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00370/AM16/
RLA File :08/24/040/00394/AM15/
Lic.No/Date:0810134414 28.01.2015 Defer Date:27.01.2016

148

Case No.:166/5/82-

ALC4/2015
Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00306/AM16/
RLA File :08/24/040/00386/AM15/
Lic.No/Date:0810134454 30.01.2015 Defer Date:27.01.2016

149

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

GANESH REMEDIES PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00696/AM16/
RLA File :34/24/040/00295/AM15/
Lic.No/Date:3410040965 16.02.2015 Defer Date:27.01.2016 Decision : The Committee based on the written comments forwarded by the D/o C&PC vide U.O.No.14010/75/2013-Ch-II dated 7.1.2016, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

150

Case No.:52/19/82-

ALC4/2014
Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01540/AM15/
RLA File :05/24/040/00273/AM15/
Lic.No/Date:0510393248 17.02.2015 Defer Date:27.01.2016

151

Case No.:38/7/82-ALC4/2015 Party Name:AUROBINDO

PHARMA LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00643/AM16/
RLA File :09/24/040/00640/AM15/
Lic.No/Date:0910061628 18.02.2015 Defer Date:27.01.2016

152

Case No.:285/5/82-

ALC4/2015
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00425/AM16/
RLA File :03/94/040/01092/AM15/
Lic.No/Date:0310793985 19.02.2015 Defer Date:27.01.2016

153

Case No.:35/7/82-ALC4/2015 Party Name:MAHARSHI

PHARMA CHEM PVT.LTD, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00640/AM16/
RLA File :08/24/040/00425/AM15/
Lic.No/Date:0810134658 24.02.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/602/2015-PI(Norms) dated December 2015 , uploaded along with these minutes or as applied by the firm action as per decision of NC

154

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

AROMACHEM PVT.LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00001/AM16/
RLA File :05/24/040/00563/AM15/
Lic.No/Date:0510393385 26.02.2015 Defer Date:27.01.2016

155

Case No.:47/19/82-

ALC4/2014
Party Name:RUBY FRAGRANCE PRIVATE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01535/AM15/
RLA File :35/24/040/00006/AM15/
Lic.No/Date:3510044692 27.02.2015 Defer Date:27.01.2016

156

Case No.:415/5/82-ALC4/2015 Party Name:BDR

PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00555/AM16/
RLA File :03/94/040/01111/AM15/
Lic.No/Date:0310794368 04.03.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/114/2015-PI(Norms) dated

Sept.2015 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

157

Case No.:444/5/82-

ALC4/2015
Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00584/AM16/
RLA File :03/94/040/01132/AM15/
Lic.No/Date:0310794412 09.03.2015 Defer Date:27.01.2016

158

Case No.:6/1/82-ALC4/2015

Party Name:MICRO LABS LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00006/AM16/
RLA File :07/24/040/00446/AM15/
Lic.No/Date:0710107776 10.03.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/400/2015-PI(Norms) dated 18th is less under para 4.07 of HBP Vol.1. The committee also decided to ignore Para 3 of the aforesaid recommendation. RA concerned may take necessary action as per decision of NC.

159

Case No.:51/19/82-

ALC4/2014
Party Name:HONOUR LAB LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01539/AM15/
RLA File :09/24/040/00693/AM15/
Lic.No/Date:0910061695 12.03.2015 Defer Date:27.01.2016 Decision : Requisite information has been received and send to DoP. The Committee decided to defer the case for want of comments from DoP.

160

Case No.:413/5/82-

ALC4/2015
Party Name:INDO AMINES LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00553/AM16/
RLA File :03/94/040/01145/AM15/
Lic.No/Date:0310794545 12.03.2015 Defer Date:27.01.2016

161

Case No.:106/7/82-

ALC4/2015
Party Name:ALCHEMIE LABORATORIES Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00711/AM16/
RLA File :03/94/040/00812/AM15/
Lic.No/Date:0310794612 16.03.2015 Defer Date:27.01.2016

Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. 35011/579/2015-PI(Norms) dated 11.12.2015 , uploaded along with these decided to send a copy of application to DCPC and deferred the case.

162

Case No.:16/1/82-ALC4/2015 Party Name:HETERO LABS

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01542/AM15/
RLA File :09/24/040/00703/AM15/
Lic.No/Date:0910061716 17.03.2015 Defer Date:27.01.2016

163

Case No.:103/7/82-

ALC4/2015
Party Name:VADIVARHE SPECIALITY CHEMICALS LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00708/AM16/
RLA File :03/95/040/01041/AM15/
Lic.No/Date:0310794641 17.03.2015 Defer Date:27.01.2016

164

Case No.:29/1/82-ALC4/2015 Party Name:HONOUR LAB

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01555/AM15/
RLA File :09/24/040/00722/AM15/
Lic.No/Date:0910061789 30.03.2015 Defer Date:27.01.2016 The Committee noted that information called for from the firm is awaited. The Committee accordingly decided await the reply and deferred the case

165

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

( ALATHUR) PRIVATE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00009/AM16/
RLA File :04/24/040/00292/AM15/
Lic.No/Date:0410160364 30.03.2015 Defer Date:27.01.2016

166

Case No.:448/5/82-

ALC4/2015
Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00588/AM16/
RLA File :03/94/040/01211/AM15/
Lic.No/Date:0310795048 31.03.2015 Defer Date:27.01.2016

167

Case No.:12/7/82-ALC4/2015 Party Name:SHILPA

MEDICARE LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00617/AM16/
RLA File :07/24/040/00002/AM16/
Lic.No/Date:0710108028 15.04.2015 Defer Date:27.01.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. 35011/640/2015-PI(Norms) dated 23.12.2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

168

Case No.:144/7/82-

ALC4/2015
Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00749/AM16/
RLA File :03/94/040/01200/AM15/
Lic.No/Date:0310795391 17.04.2015 Defer Date:27.01.2016

169

Case No.:32/5/82-ALC4/2015 Party Name:LANTECH

PHARMACEUTICALS LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00172/AM16/
RLA File :09/24/040/00011/AM16/
Lic.No/Date:0910061900 20.04.2015 Defer Date:27.01.2016

170

Case No.:147/7/82-

ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00752/AM16/
RLA File :03/94/040/00036/AM16/
Lic.No/Date:0310795446 21.04.2015 Defer Date:27.01.2016

171

Case No.:164/13/82-

ALC4/2015
Party Name:NUTRA SPECIALITIES PVT. LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01127/AM16/
RLA File :04/24/040/00004/AM16/
Lic.No/Date:0410160435 23.04.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/213/2015-FPI(Norms) dated Sept.2015 , uploaded along with these minutes or as applied by the firm whichever is

decision of NC.

172

Case No.:173/7/82-ALC4/2015 Party Name:UNIMAX

LABORATORIES PVT.LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00778/AM16/
RLA File :03/95/040/00031/AM16/
Lic.No/Date:0310795525 24.04.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/566/2015-FPI(Norms) dated December 2015 , uploaded along with these minutes or as applied by the firm

173

Case No.:174/7/82-

ALC4/2015
Party Name:S M B CORPORATION OF INDIA Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00779/AM16/
RLA File :03/95/040/00039/AM16/
Lic.No/Date:0310795601 28.04.2015 Defer Date:27.01.2016

174

Case No.:151/7/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00756/AM16/
RLA File :03/94/040/01216/AM15/
Lic.No/Date:0310795663 30.04.2015 Defer Date:27.01.2016 Decision :Requisite information has been received and sent to DoP for comments.

175

Case No.:8/13/82-ALC4/2015 Party Name:DORF-KETAL

CHEMICALS INDIA PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00971/AM16/
RLA File :03/94/040/00044/AM16/
Lic.No/Date:0310795702 05.05.2015 Defer Date:27.01.2016

176

Case No.:47/13/82-ALC4/2015 Party Name:ETERNIS FINE

CHEMICALS LIMITED, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01010/AM16/
RLA File :03/94/040/00016/AM16/
Lic.No/Date:0310795703 05.05.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC U.O.No.14010/57/2012-Ch-II dated 21.12.2015 , uploaded along with these minutes or as applied

by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary

177

Case No.:50/7/82-ALC4/2015 Party Name:ARENE LIFE

SCIENCES LIMITED. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00655/AM16/
RLA File :09/24/040/00041/AM16/
Lic.No/Date:0910061976 06.05.2015 Defer Date:27.01.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.35011/587/2015-PI(Norms) dated December 2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

178

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

PHARMACHEM PVT. LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00609/AM16/
RLA File :08/24/040/00006/AM16/
Lic.No/Date:0810135194 06.05.2015 Defer Date:27.01.2016

179

Case No.:11/7/82-ALC4/2015 Party Name:CADILA

HEALTHCARE LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00616/AM16/
RLA File :08/24/040/00016/AM16/
Lic.No/Date:0810135204 07.05.2015 Defer Date:27.01.2016

180

Case No.:23/7/82-ALC4/2015 Party Name:CADILA

HEALTHCARE LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00628/AM16/
RLA File :08/24/040/00028/AM16/
Lic.No/Date:0810135220 07.05.2015 Defer Date:27.01.2016

181

Case No.:20/7/82-ALC4/2015 Party Name:MAHARSHI

PHARMA CHEM PVT.LTD, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00625/AM16/
RLA File :08/24/040/00035/AM16/
Lic.No/Date:0810135219 07.05.2015 Defer Date:27.01.2016

182 Case No.:3/3/82-ALC4/2015 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:15/82- ALC4/2015 Status:Case Deferred

30.12.2015 HQ File :01/82/050/00033/AM16/
RLA File :09/24/040/00077/AM16/
Lic.No/Date:0910061994 07.05.2015 Defer Date:27.01.2016 Decision : The Committee decided to send copy of application to DoP and deferred the case for want of comments.

183

Case No.:108/7/82-

ALC4/2015
Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00713/AM16/
RLA File :03/95/040/00003/AM16/
Lic.No/Date:0310795745 07.05.2015 Defer Date:27.01.2016 The Committee accordingly decided await the reply and deferred the case

184

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

PARENTERALS PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00612/AM16/
RLA File :08/24/040/00017/AM16/
Lic.No/Date:0810135225 08.05.2015 Defer Date:27.01.2016

185

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

PARENTERALS PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00613/AM16/
RLA File :08/24/040/00018/AM16/
Lic.No/Date:0810135226 08.05.2015 Defer Date:27.01.2016

186

Case No.:117/7/82-

ALC4/2015
Party Name:ZIM LABORATORIES LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00722/AM16/
RLA File :03/95/040/00079/AM16/
Lic.No/Date:0310795788 08.05.2015 Defer Date:27.01.2016

187

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

SYNTHESIS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00620/AM16/
RLA File :52/24/040/00007/AM16/
Lic.No/Date:5210041517 11.05.2015 Defer Date:27.01.2016

188

Case No.:140/7/82-ALC4/2015 Party Name:LUPIN LIMITED

Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved

HQ File :01/82/050/00745/AM16/
RLA File :03/95/040/00067/AM16/
Lic.No/Date:0310795839 12.05.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/589/2015-PI(Norms) dated November 2015 , uploaded along with these minutes or as applied by the firm

189

Case No.:49/7/82-ALC4/2015 Party Name:BRUNDAVAN

LABORATORIES PRIVATE LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00654/AM16/
RLA File :09/24/040/00059/AM16/
Lic.No/Date:0910062011 13.05.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/642/2015-PI(Norms) dated 23.12.2015, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of

190

Case No.:7/13/82-ALC4/2015 Party Name:AUROBINDO

PHARMA LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00970/AM16/
RLA File :09/24/040/00046/AM16/
Lic.No/Date:0910062017 14.05.2015 Defer Date:27.01.2016

191

Case No.:5/3/82-ALC4/2015

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00035/AM16/
RLA File :09/24/040/00081/AM16/
Lic.No/Date:0910062019 14.05.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/547/2015-PI(Norms) dated 03.12.2015 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of

192

Case No.:129/7/82-

ALC4/2015
Party Name:NATIONAL TUBE INDUSTRIES, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00734/AM16/
RLA File :03/95/040/00073/AM16/
Lic.No/Date:0310795930 14.05.2015 Defer Date:27.01.2016

193

Case No.:6/7/82-ALC4/2015 Party Name:SIMPEX

PHARMA PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred

HQ File :01/82/050/00611/AM16/
RLA File :05/24/040/00564/AM15/
Lic.No/Date:0510394266 15.05.2015 Defer Date:27.01.2016

194

Case No.:164/7/82-

ALC4/2015
Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00769/AM16/
RLA File :03/94/040/00026/AM16/
Lic.No/Date:0310795971 18.05.2015 Defer Date:27.01.2016

195

Case No.:126/7/82-ALC4/2015 Party Name:SANDOZ

PRIVATE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00731/AM16/
RLA File :03/95/040/00071/AM16/
Lic.No/Date:0310795986 18.05.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/562/2015-PI(Norms) dated December 2015 , uploaded along with these minutes or as applied by the firm

196

Case No.:109/7/82-

ALC4/2015
Party Name:ZIM LABORATORIES LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00714/AM16/
RLA File :03/95/040/00103/AM16/
Lic.No/Date:0310795994 18.05.2015 Defer Date:27.01.2016

197

Case No.:160/7/82-ALC4/2015 Party Name:GUJARAT

ORGANICS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00765/AM16/
RLA File :03/94/040/00121/AM16/
Lic.No/Date:0310796029 19.05.2015 Defer Date: Decision : Already approved in NC.3 meeting no.09/82 dt. 30.09.2015.

198

Case No.:133/7/82-

ALC4/2015
Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00738/AM16/
RLA File :03/94/040/00085/AM16/
Lic.No/Date:0310796048 20.05.2015 Defer Date:27.01.2016 Decision : The Committee decided to defer the case for want of comments of DC&PC.

199 Case No.:41/7/82-ALC4/2015 Party Name:KORES (INDIA) Meet No/Date:15/82- Status:Case

LTD. ALC4/2015 30.12.2015 Approved HQ File :01/82/050/00646/AM16/
RLA File :31/83/040/00196/AM15/
Lic.No/Date:3110065441 20.05.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/583/2015-PI(Norms) dated 11.12.2015 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of

200

Case No.:102/7/82-

ALC4/2015
Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00707/AM16/
RLA File :30/24/040/00006/AM16/
Lic.No/Date:3010103498 21.05.2015 Defer Date:27.01.2016

201

Case No.:51/7/82-ALC4/2015 Party Name:BHAGIRADHA

CHEMICALS & INDUSTRIES LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00656/AM16/
RLA File :09/24/040/00096/AM16/
Lic.No/Date:0910062060 22.05.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC U.O.no.14010/17/2012-C-II dated 15.12.2015 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary

202

Case No.:55/13/82-

ALC4/2015
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01018/AM16/
RLA File :07/24/040/00036/AM16/
Lic.No/Date:0710108251 22.05.2015 Defer Date:27.01.2016

203

Case No.:167/7/82-ALC4/2015 Party Name:IPCA

Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00772/AM16/
RLA File :03/94/040/00041/AM16/
Lic.No/Date:0310796129 22.05.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No. 35011/653/2013-PI(Norms) dated 22.1.2014, uploaded along with these minutes or as applied by the firm whichever is decision of NC.

204

Case No.:3/4/82-ALC4/2015

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Rejected

HQ File :01/82/050/00042/AM16/
RLA File :09/24/040/00104/AM16/
Lic.No/Date:0910062064 25.05.2015 Defer Date: Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. 35011/630/2015-PI(Norms) dated 21.12.2015 , uploaded along with these minutes decided to reject the case.

205

Case No.:13/7/82-ALC4/2015 Party Name:MOREPEN

LABORATORIES LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00618/AM16/
RLA File :05/24/040/00074/AM16/
Lic.No/Date:0510394343 25.05.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/598/2015-PI(Norms) dated decision of NC.

206

Case No.:170/7/82-ALC4/2015 Party Name:FERMENTA

BIOTECH LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00775/AM16/
RLA File :03/94/040/00009/AM16/
Lic.No/Date:0310796191 26.05.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No. 35011/577/2015-PI(Norms) dated decision of NC.

207

Case No.:176/7/82-

ALC4/2015
Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00781/AM16/
RLA File :03/94/040/00124/AM16/
Lic.No/Date:0310796194 26.05.2015 Defer Date:27.01.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. 35011/626/2015-PI(Norms) dated 21.12.2015 , uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

208

Case No.:166/7/82-ALC4/2015 Party Name:IPCA

Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00771/AM16/
RLA File :03/94/040/00063/AM16/
Lic.No/Date:0310796196 26.05.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No. 35011/558/2015-PI(Norms) dated December 2015 uploaded along with these minutes or as applied by the firm whichever

decision of NC.

209

Case No.:124/7/82-

ALC4/2015
Party Name:PRIVI ORGANICS LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00729/AM16/
RLA File :03/95/040/00114/AM16/
Lic.No/Date:0310796233 27.05.2015 Defer Date:27.01.2016 Decision : The Committee decided to defer the case for want of comments of DC&PC.

210

Case No.:100/7/82-

ALC4/2015
Party Name:SHREE GANESH REMEDIES PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00705/AM16/
RLA File :34/24/040/00024/AM16/
Lic.No/Date:3410041261 28.05.2015 Defer Date:27.01.2016 Decision : The Committee decided to defer the case for want of comments of DC&PC.

211

Case No.:184/7/82-ALC4/2015 Party Name:THEON

PHARMACEUTICALS LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00789/AM16/
RLA File :22/24/040/00009/AM16/
Lic.No/Date:2210015246 28.05.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/500/2015-PI(Norms) dated 23.12.2015 , uploaded along with these minutes or as applied by the firm whichever is decision of NC.

212

Case No.:188/7/82-

ALC4/2015
Party Name:ATUL LIMITED, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00793/AM16/
RLA File :08/24/040/00034/AM16/
Lic.No/Date:0810135421 02.06.2015 Defer Date:27.01.2016

213

Case No.:14/7/82-ALC4/2015 Party Name:DHANUKA

LABORATORIES LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00619/AM16/
RLA File :05/23/040/00075/AM16/
Lic.No/Date:0510394413 02.06.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No. 35011/601/2015-PI(Norms) dated

decision of NC.

214

Case No.:5/7/82-ALC4/2015 Party Name:SUN

PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00610/AM16/
RLA File :05/24/040/00090/AM16/
Lic.No/Date:0510394416 02.06.2015 Defer Date:27.01.2016

215

Case No.:142/7/82-

ALC4/2015
Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00747/AM16/
RLA File :03/94/040/00159/AM16/
Lic.No/Date:0310796401 03.06.2015 Defer Date:27.01.2016 Decision : The Committee decided to defer the case for want of comments of DOP.

216

Case No.:134/7/82-ALC4/2015 Party Name:INDOCO

REMEDIES LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00739/AM16/
RLA File :03/94/040/00154/AM16/
Lic.No/Date:0310796399 03.06.2015 Defer Date: Decision : The Committee decided to ratify norms as per SION A-412 under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

217

Case No.:110/7/82-

ALC4/2015
Party Name:RISHABH METALS & CHEMICALS PVT LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00715/AM16/
RLA File :03/95/040/00051/AM16/
Lic.No/Date:0310796383 03.06.2015 Defer Date:27.01.2016

218

Case No.:16/7/82-ALC4/2015 Party Name:SUN

PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00621/AM16/
RLA File :05/24/040/00084/AM16/
Lic.No/Date:0510394419 03.06.2015 Defer Date:27.01.2016

219

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

PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00622/AM16/
RLA File :05/24/040/00078/AM16/
Lic.No/Date:0510394418 03.06.2015 Defer Date:27.01.2016

220

Case No.:187/7/82-

ALC4/2015
Party Name:ATUL LIMITED, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00792/AM16/
RLA File :08/24/040/00057/AM16/
Lic.No/Date:0810135435 05.06.2015 Defer Date:27.01.2016

221

Case No.:62/7/82-ALC4/2015 Party Name:EYTAN LABS

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00667/AM16/
RLA File :09/24/040/00598/AM15/
Lic.No/Date:0910062137 05.06.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No. 35011/623/2015-PI(Norms) dated 21.12.2015, uploaded along with these minutes or as applied by the firm whichever is decision of NC.

222

Case No.:135/7/82-ALC4/2015 Party Name:INDOCO

REMEDIES LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00740/AM16/
RLA File :03/94/040/00153/AM16/
Lic.No/Date:0310796471 05.06.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/353/2015-PI(Norms) dated November 2015 , uploaded along with these minutes or as applied by the firm

223

Case No.:67/7/82-ALC4/2015 Party Name:OPTIMUS

DRUGS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00672/AM16/
RLA File :09/24/040/00105/AM16/
Lic.No/Date:0910062138 05.06.2015 Defer Date:27.01.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. No.35011/571/2015-PI(Norms) dated December 2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

224

Case No.:13/9/82-ALC4/2015 Party Name:SHILPA

MEDICARE LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File RLA File Lic.No/Date:0710108327 Defer

:01/82/050/00949/AM16/
:07/24/040/00081/AM16/
05.06.2015 Date:27.01.2016

225

Case No.:121/7/82-

ALC4/2015
Party Name:UNIMARK REMEDIES LIMITED., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00726/AM16/
RLA File :03/95/040/00715/AM15/
Lic.No/Date:0310796458 05.06.2015 Defer Date:27.01.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. No.35011/561/2015-PI(Norms) dated December 2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

226

Case No.:123/7/82-

ALC4/2015
Party Name:UNIMARK REMEDIES LIMITED., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00728/AM16/
RLA File :03/95/040/00582/AM15/
Lic.No/Date:0310796457 05.06.2015 Defer Date:27.01.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. No.35011/560/2015-PI(Norms) dated December 2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

227

Case No.:97/7/82-ALC4/2015 Party Name:ALEMBIC

PHARMACEUTICALS LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00702/AM16/
RLA File :34/24/040/00062/AM16/
Lic.No/Date:3410041281 09.06.2015 Defer Date:27.01.2016

228

Case No.:136/7/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00741/AM16/
RLA File :03/94/040/00032/AM16/
Lic.No/Date:0310796511 09.06.2015 Defer Date:27.01.2016

229

Case No.:85/7/82-ALC4/2015 Party Name:SHREEGEN

PHARMA LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00690/AM16/
RLA File :09/24/040/00130/AM16/
Lic.No/Date:0910062145 09.06.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/555/2015-PI(Norms) dated December 2015 , uploaded along with these minutes or as applied by the firm

230

Case No.:60/7/82-ALC4/2015 Party Name:GRANULES

INDIA LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00665/AM16/
RLA File :09/24/040/00126/AM16/
Lic.No/Date:0910062150 10.06.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/607/2015-PI(Norms) dated 16.12.2015 , uploaded along with these minutes or as applied by the firm whichever is decision of NC.

231

Case No.:61/7/82-ALC4/2015 Party Name:GRANULES

INDIA LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00666/AM16/
RLA File :09/24/040/00141/AM16/
Lic.No/Date:0910062149 10.06.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/550/2015-PI(Norms) dated 16.12.2015 , uploaded along with these minutes or as applied by the firm whichever is decision of NC.

232

Case No.:137/7/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00742/AM16/
RLA File :03/94/040/00074/AM16/
Lic.No/Date:0310796546 10.06.2015 Defer Date:27.01.2016

233

Case No.:18/13/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00981/AM16/
RLA File :03/94/040/00084/AM16/
Lic.No/Date:0310796548 10.06.2015 Defer Date:27.01.2016 Decision : Requisite information has been received and sent to DoP for comments.

234

Case No.:21/13/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00984/AM16/
RLA File :03/94/040/00078/AM16/
Lic.No/Date:0310796547 10.06.2015 Defer Date:27.01.2016

235

Case No.:14/9/82-ALC4/2015 Party Name:SHILPA

MEDICARE LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00950/AM16/
RLA File :07/24/040/00078/AM16/
Lic.No/Date:0710108349 10.06.2015 Defer Date:27.01.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. No.35011/640/2015-PI(Norms) dated 23.12. 2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

236

Case No.:65/7/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00670/AM16/
RLA File :09/24/040/00164/AM16/
Lic.No/Date:0910062163 10.06.2015 Defer Date:27.01.2016

237

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

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00671/AM16/
RLA File :09/24/040/00162/AM16/
Lic.No/Date:0910062162 10.06.2015 Defer Date:27.01.2016

238

Case No.:19/13/82-

ALC4/2015
Party Name:AMRUTA INDUSTRIES Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00982/AM16/
RLA File :03/94/040/00156/AM16/
Lic.No/Date:0310796569 11.06.2015 Defer Date:27.01.2016

239

Case No.:20/13/82-

ALC4/2015
Party Name:JAYANT AGRO ORGANICS LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00983/AM16/
RLA File :03/94/040/00169/AM16/
Lic.No/Date:0310796563 11.06.2015 Defer Date:27.01.2016

240

Case No.:159/7/82-

ALC4/2015
Party Name:VIJAY PERFUMES PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00764/AM16/
RLA File :03/95/040/00985/AM15/
Lic.No/Date:0310796576 11.06.2015 Defer Date:27.01.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.No.35011/612/2015-PI(Norms) dated 17.12.2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

241

Case No.:87/7/82-ALC4/2015 Party Name:VISION DRUGS

PVT LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00692/AM16/
RLA File :09/24/040/00102/AM16/
Lic.No/Date:0910062168 11.06.2015 Defer Date:27.01.2016

242

Case No.:42/13/82-

ALC4/2015
Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01005/AM16/
RLA File :03/94/040/00177/AM16/
Lic.No/Date:0310796604 15.06.2015 Defer Date:27.01.2016

243

Case No.:84/13/82-

ALC4/2015
Party Name:TIDE INDUSTRIES Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01047/AM16/
RLA File :34/24/040/00066/AM16/
Lic.No/Date:3410041297 15.06.2015 Defer Date:27.01.2016 Decision : The Committee based on the written comments forwarded by the D/o C&PC, U.O.No.14010/85/2010-Ch-II dated 21.12.2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

244

Case No.:41/13/82-

ALC4/2015
Party Name:DANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01004/AM16/
RLA File :03/94/040/00111/AM16/
Lic.No/Date:0310796667 16.06.2015 Defer Date:27.01.2016

245

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

PVT.LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00657/AM16/
RLA File :05/23/040/00107/AM16/
Lic.No/Date:0510394590 17.06.2015 Defer Date:27.01.2016

246

Case No.:190/7/82-ALC4/2015 Party Name:SUN

PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00795/AM16/
RLA File :05/24/040/00105/AM16/
Lic.No/Date:0510394617 17.06.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/565/2015-PI(Norms) dated

December 2015 , uploaded along with these minutes or as applied by the firm

247

Case No.:37/13/82-

ALC4/2015
Party Name:ATLAS FINE CHEMICALS PVT LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01000/AM16/
RLA File :03/94/040/00148/AM16/
Lic.No/Date:0310796714 18.06.2015 Defer Date:27.01.2016

248

Case No.:43/13/82-

ALC4/2015
Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01006/AM16/
RLA File :03/94/040/00178/AM16/
Lic.No/Date:0310796712 18.06.2015 Defer Date:27.01.2016

249

Case No.:15/9/82-ALC4/2015 Party Name:KDAC CHEM

PVT LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00951/AM16/
RLA File :34/24/040/00069/AM16/
Lic.No/Date:3410041310 22.06.2015 Defer Date:27.01.2016

250

Case No.:183/7/82-ALC4/2015 Party Name:SAURAV

CHEMICALS LTD, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00788/AM16/
RLA File :22/24/040/00010/AM16/
Lic.No/Date:2210015259 22.06.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/553/2015-PI(Norms) dated December 2015 , uploaded along with these minutes or as applied by the firm action as per decision of NC

251

Case No.:2/6/82-ALC4/2015 Party Name:AUROBINDO

PHARMA LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00598/AM16/
RLA File :09/24/040/00165/AM16/
Lic.No/Date:0910062242 23.06.2015 Defer Date:27.01.2016. Decision : The Committee decided to defer the case for want of comments of DoP

252 Case No.:26/13/82- Party Name:KOPRAN Meet No/Date:15/82- Status:Case

ALC4/2015
RESEARCH LABORATORIES LTD. ALC4/2015 30.12.2015 Deferred HQ File :01/82/050/00989/AM16/
RLA File :03/94/040/00164/AM16/
Lic.No/Date:0310796757 23.06.2015 Defer Date:27.01.2016

253

Case No.:27/13/82-

ALC4/2015
Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00990/AM16/
RLA File :03/94/040/00197/AM16/
Lic.No/Date:0310796759 23.06.2015 Defer Date:27.01.2016

254

Case No.:28/13/82-

ALC4/2015
Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00991/AM16/
RLA File :03/94/040/00162/AM16/
Lic.No/Date:0310796761 23.06.2015 Defer Date:27.01.2016

255

Case No.:29/13/82-

ALC4/2015
Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00992/AM16/
RLA File :03/94/040/00161/AM16/
Lic.No/Date:0310796756 23.06.2015 Defer Date:27.01.2016

256

Case No.:31/13/82-

ALC4/2015
Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00994/AM16/
RLA File :03/94/040/00198/AM16/
Lic.No/Date:0310796762 23.06.2015 Defer Date:27.01.2016

257

Case No.:83/13/82-

ALC4/2015
Party Name:RIDDHI PHARMA Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01046/AM16/
RLA File :34/24/040/00087/AM16/
Lic.No/Date:3410041313 23.06.2015 Defer Date:27.01.2016

258

Case No.:15/13/82-

ALC4/2015
Party Name:ALIVIRA ANIMAL HEALTH LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00978/AM16/
RLA File :03/94/040/00219/AM16/
Lic.No/Date:0310796797 24.06.2015 Defer Date:27.01.2016

259

Case No.:45/7/82-ALC4/2015 Party Name:EYTAN LABS

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00650/AM16/
RLA File :09/24/040/00135/AM16/
Lic.No/Date:0910062250 24.06.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/599/2015-PI(Norms) dated decision of NC.

260

Case No.:16/13/82-

ALC4/2015
Party Name:IPCA Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00979/AM16/
RLA File :03/94/040/00224/AM16/
Lic.No/Date:0310796798 24.06.2015 Defer Date:27.01.2016

261

Case No.:64/7/82-ALC4/2015 Party Name:TRIMAX BIO

SCIENCES PRIVATE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00669/AM16/
RLA File :09/24/040/00133/AM16/
Lic.No/Date:0910062246 24.06.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/568/2015-PI(Norms) dated December 2015 , uploaded along with these minutes or as applied by the firm

262

Case No.:48/7/82-ALC4/2015 Party Name:MYLAN

Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00653/AM16/
RLA File :09/24/040/00118/AM16/
Lic.No/Date:0910062253 25.06.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/596/2015-PI(Norms) dated 11.12.2015 , uploaded along with these minutes or as applied by the firm whichever is decision of NC.

263 Case No.:72/7/82-ALC4/2015 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:15/82- ALC4/2015 Status:Case Deferred

30.12.2015 HQ File :01/82/050/00677/AM16/
RLA File :05/24/040/00104/AM16/
Lic.No/Date:0510394704 25.06.2015 Defer Date:27.01.2016

264

Case No.:76/7/82-ALC4/2015 Party Name:PCL OIL &

SOLVENTS LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00681/AM16/
RLA File :05/24/040/00103/AM16/
Lic.No/Date:0510394703 25.06.2015 Defer Date:27.01.2016

265

Case No.:75/7/82-ALC4/2015 Party Name:SENTISS

PHARMA PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00680/AM16/
RLA File :05/24/040/00122/AM16/
Lic.No/Date:0510394696 25.06.2015 Defer Date:27.01.2016

266

Case No.:78/7/82-ALC4/2015 Party Name:WEST BENGAL

CHEMICAL INDUSTRIES LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00683/AM16/
RLA File :02/24/040/00028/AM16/
Lic.No/Date:0210205920 25.06.2015 Defer Date:27.01.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. 35011/556/2015-PI(Norms) dated December 2015 , uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

267

Case No.:89/7/82-ALC4/2015 Party Name:HALDIA

PETROCHEMICALS LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00694/AM16/
RLA File :02/24/040/00045/AM16/
Lic.No/Date:0210205925 26.06.2015 Defer Date:27.01.2016

268

Case No.:77/7/82-ALC4/2015 Party Name:SENTISS

PHARMA PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00682/AM16/
RLA File :05/24/040/00130/AM16/
Lic.No/Date:0510394732 26.06.2015 Defer Date:27.01.2016

269

Case No.:26/7/82-ALC4/2015 Party Name:SOFTGEL

HEALTH CARE PVT. LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00631/AM16/
RLA File :04/24/040/00072/AM16/
Lic.No/Date:0410160709 26.06.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/498/2015-PI(Norms) dated 23.12.2015, uploaded along with these minutes or as applied by the firm whichever is decision of NC.

270

Case No.:44/7/82-ALC4/2015 Party Name:LEE PHARMA

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00649/AM16/
RLA File :09/24/040/00201/AM16/
Lic.No/Date:0910062263 30.06.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/633/2015-PI(Norms) dated 23.12.2015, uploaded along with these minutes or as applied by the firm whichever is decision of NC.

271

Case No.:42/7/82-ALC4/2015 Party Name:CLEAN

SCIENCE AND TECHNOLOGY PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00647/AM16/
RLA File :31/83/040/00030/AM16/
Lic.No/Date:3110065521 01.07.2015 Defer Date:27.01.2016

272

Case No.:10/13/82-

ALC4/2015
Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00973/AM16/
RLA File :03/94/040/00229/AM16/
Lic.No/Date:0310797018 02.07.2015 Defer Date:27.01.2016

273

Case No.:11/13/82-

ALC4/2015
Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00974/AM16/
RLA File :03/94/040/00228/AM16/
Lic.No/Date:0310797020 02.07.2015 Defer Date:27.01.2016

274

Case No.:24/13/82-

ALC4/2015
Party Name:DANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred

HQ File :01/82/050/00987/AM16/
RLA File :03/94/040/00226/AM16/
Lic.No/Date:0310797092 07.07.2015 Defer Date:27.01.2016

275

Case No.:32/13/82-

ALC4/2015
Party Name:FDC LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00995/AM16/
RLA File :03/94/040/00263/AM16/
Lic.No/Date:0310797090 07.07.2015 Defer Date:27.01.2016

276

Case No.:53/13/82-

ALC4/2015
Party Name:FINE ORGANIC INDUSTRIES PVT. LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01016/AM16/
RLA File :03/94/040/00225/AM16/
Lic.No/Date:0310797089 07.07.2015 Defer Date:27.01.2016

277

Case No.:82/13/82-

ALC4/2015
Party Name:PAB ORGANICS PVT.LTD, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01045/AM16/
RLA File :34/24/040/00084/AM16/
Lic.No/Date:3410041360 07.07.2015 Defer Date:27.01.2016 Decision : The Committee based on the written comments forwarded by the D/o C&PC, 14010/84/2015-Ch-II dated 15.12.2015 , uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

278

Case No.:2/7/82-ALC4/2015 Party Name:HETERO LABS

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00607/AM16/
RLA File :09/24/040/00213/AM16/
Lic.No/Date:0910062316 08.07.2015 Defer Date:27.01.2016

279

Case No.:44/14/82-

ALC4/2015
Party Name:INDO PHYTO CHEMICALS PVT LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01180/AM16/
RLA File :05/23/040/00147/AM16/
Lic.No/Date:0510394839 08.07.2015 Defer Date:27.01.2016

280

Case No.:103/8/82-ALC4/2015 Party Name:SUNSHIELD

CHEMICALS LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00899/AM16/
RLA File :03/95/040/00266/AM16/
Lic.No/Date:0310797135 09.07.2015 Defer Date:

D/o C&PC, forwarded vide U.O.No.14010/107/2010-Ch-II dated 27.10.2015, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of

281

Case No.:9/13/82-ALC4/2015 Party Name:DORF-KETAL

CHEMICALS INDIA PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00972/AM16/
RLA File :03/94/040/00176/AM16/
Lic.No/Date:0310797178 13.07.2015 Defer Date: D/o C&PC, forwarded vide U.O.No.14010/176/2011-Ch-II dated 15.12.2015, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of

282

Case No.:12/13/82-ALC4/2015 Party Name:ALKYL AMINES

CHEMICALS LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00975/AM16/
RLA File :03/94/040/00003/AM16/
Lic.No/Date:0310797246 15.07.2015 Defer Date: D/o C&PC, forwarded vide U.O.No.14010/85/2012-Ch-II dated 08.12.2015, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of

283

Case No.:13/13/82-ALC4/2015 Party Name:AVA

CHEMICALS PVT.LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00976/AM16/
RLA File :03/94/040/00232/AM16/
Lic.No/Date:0310797262 15.07.2015 Defer Date: D/o C&PC, forwarded vide U.O.No.14010/67/2011-Ch-II dated 22.06.2015, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of

284

Case No.:14/13/82-ALC4/2015 Party Name:DORF-KETAL

CHEMICALS INDIA PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00977/AM16/
RLA File :03/94/040/00221/AM16/
Lic.No/Date:0310797252 15.07.2015 Defer Date: D/o C&PC, forwarded vide U.O.No.14010/176/2011-Ch-II dated 15.12.2015, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of

285

Case No.:23/13/82-

ALC4/2015
Party Name:K V AROCHEM PVT. LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00986/AM16/
RLA File :03/94/040/00284/AM16/
Lic.No/Date:0310797268 15.07.2015 Defer Date:27.01.2016

286

Case No.:22/13/82-

ALC4/2015
Party Name:BLISS INDASI LIFESCIENCES PVT LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00985/AM16/
RLA File :03/94/040/00282/AM16/
Lic.No/Date:0310797355 17.07.2015 Defer Date:27.01.2016

287

Case No.:185/7/82-ALC4/2015 Party Name:AUROBINDO

PHARMA LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/00790/AM16/
RLA File :09/24/040/00219/AM16/
Lic.No/Date:0910062355 21.07.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No. 35011/637/2015-PI(Norms) dated 23.12.2015, uploaded along with these minutes or as applied by the firm whichever is decision of NC.

288

Case No.:93/13/82-ALC4/2015 Party Name:CIPLA LIMITED. Meet No/Date:15/82-

ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01056/AM16/
RLA File :03/94/040/00303/AM16/
Lic.No/Date:0310797532 22.07.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/54/2015-PI(Norms) dated 4.1.2016 , uploaded along with these minutes or as applied by the firm whichever is less under

para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

289

Case No.:94/13/82-ALC4/2015 Party Name:CIPLA LIMITED. Meet No/Date:15/82-

ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01057/AM16/
RLA File :03/94/040/00297/AM16/
Lic.No/Date:0310797529 22.07.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/54/2015-PI(Norms) dated 4.1.2016 , uploaded along with these minutes or as applied by the firm whichever is less under

para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

290 Case No.:119/8/82- Party Name:SI GROUP Meet No/Date:15/82- Status:Case

ALC4/2015
INDIA LIMITED ALC4/2015 30.12.2015 Deferred HQ File :01/82/050/00915/AM16/
RLA File :03/95/040/00322/AM16/
Lic.No/Date:0310797595 23.07.2015 Defer Date:27.01.2016

291

Case No.:98/13/82-ALC4/2015 Party Name:CIPLA LIMITED. Meet No/Date:15/82-

ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01061/AM16/
RLA File :03/94/040/00313/AM16/
Lic.No/Date:0310797651 24.07.2015 Date:
D/o Pharmaceuticals forwarded vide O.M. No.35011/435/2015-PI(Norms) dated 11.1.2016 , uploaded along with these minutes or as applied by the firm whichever is decision of NC.

292

Case No.:99/13/82-ALC4/2015 Party Name:CIPLA LIMITED. Meet No/Date:15/82-

ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01062/AM16/
RLA File :03/94/040/00312/AM16/
Lic.No/Date:0310797650 24.07.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/618/2015-PI(Norms) dated 4.1.2016 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

293

Case No.:132/13/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01095/AM16/
RLA File :03/94/040/00298/AM16/
Lic.No/Date:0310797652 24.07.2015 Defer Date: Decision :The committee considered the case and decided to ratify norms as per SION A-1945 with 1% wastage under para 4.7 of HBP. RA concerned take further necessary

294

Case No.:133/13/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01096/AM16/
RLA File :03/94/040/00306/AM16/
Lic.No/Date:0310797633 24.07.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/618/2015-PI(Norms) dated 4.1.2016 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

295

Case No.:115/13/82-

ALC4/2015
Party Name:FERMENTA BIOTECH LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01078/AM16/
RLA File :03/94/040/00038/AM16/
Lic.No/Date:0310797627 24.07.2015 Defer Date:27.01.2016

296

Case No.:97/13/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01060/AM16/
RLA File :03/94/040/00327/AM16/
Lic.No/Date:0310797799 29.07.2015 Defer Date:27.01.2016 Decision : The Committee decided to defer the case for want of comments of DoP

297

Case No.:100/13/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01063/AM16/
RLA File :03/94/040/00328/AM16/
Lic.No/Date:0310797802 29.07.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/620/2015-PI(Norms) dated 4.1.2016 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

298

Case No.:101/13/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved
HQ File :01/82/050/01064/AM16/
RLA File :03/94/040/00333/AM16/
Lic.No/Date:0310797805 29.07.2015 Defer Date:
Decision : : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/435/2015-PI(Norms) dated 11.1.2016 , uploaded along with these minutes or as applied by the firm whichever is decision of NC.

299

Case No.:117/13/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01080/AM16/
RLA File :03/94/040/00323/AM16/
Lic.No/Date:0310797801 29.07.2015 Defer Date:

D/o Pharmaceuticals forwarded vide O.M. No.35011/620/2015-PI(Norms) dated 4.1.2016 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

300

Case No.:118/13/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01081/AM16/
RLA File :03/94/040/00332/AM16/
Lic.No/Date:0310797803 29.07.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/620/2015-PI(Norms) dated 4.1.2016 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

301

Case No.:119/13/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01082/AM16/
RLA File :03/94/040/00309/AM16/
Lic.No/Date:0310797783 29.07.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/54/2015-PI(Norms) dated 4.1.2016 , uploaded along with these minutes or as applied by the firm whichever is less under

para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

302

Case No.:69/13/82-ALC4/2015 Party Name:PI INDUSTRIES

LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01032/AM16/
RLA File :13/24/040/00016/AM16/
Lic.No/Date:1310047933 29.07.2015 Defer Date:

303

Case No.:92/13/82-

ALC4/2015
Party Name:INFINITY LABORATORIES PVT.LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01055/AM16/
RLA File :22/24/040/00027/AM16/
Lic.No/Date:2210015273 31.07.2015 Defer Date:27.01.2016

304

Case No.:116/13/82-

ALC4/2015
Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01079/AM16/
RLA File :03/94/040/00215/AM16/
Lic.No/Date:0310797864 31.07.2015 Defer Date:27.01.2016

305

Case No.:114/13/82-

ALC4/2015
Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01077/AM16/
RLA File :03/94/040/00258/AM16/
Lic.No/Date:0310797898 03.08.2015 Defer Date:27.01.2016

306

Case No.:113/13/82-

ALC4/2015
Party Name:K V AROCHEM PVT. LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01076/AM16/
RLA File :03/94/040/00335/AM16/
Lic.No/Date:0310797897 03.08.2015 Defer Date:27.01.2016

307

Case No.:112/13/82-

ALC4/2015
Party Name:K V AROCHEM PVT. LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01075/AM16/
RLA File :03/94/040/00345/AM16/
Lic.No/Date:0310797937 04.08.2015 Defer Date:27.01.2016

308

Case No.:75/13/82-

ALC4/2015
Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01038/AM16/
RLA File :05/24/040/00215/AM16/
Lic.No/Date:0510395160 04.08.2015 Defer Date:27.01.2016

309

Case No.:78/13/82-

ALC4/2015
Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01041/AM16/
RLA File :05/24/040/00219/AM16/
Lic.No/Date:0510395169 04.08.2015 Defer Date:27.01.2016

310

Case No.:109/13/82-

ALC4/2015
Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01072/AM16/
RLA File :03/94/040/00170/AM16/
Lic.No/Date:0310797954 05.08.2015 Defer Date:27.01.2016

311

Case No.:50/13/82-

ALC4/2015
Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01013/AM16/
RLA File :04/24/040/00095/AM16/
Lic.No/Date:0410160884 06.08.2015 Defer Date:27.01.2016

312

Case No.:108/13/82-

ALC4/2015
Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01071/AM16/
RLA File :03/94/040/00150/AM16/
Lic.No/Date:0310798022 07.08.2015 Defer Date: D/o C&PC, forwarded vide U.O.No.14010/100/2010-Ch-II dated 01.01.2016, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of

313

Case No.:166/13/82-

ALC4/2015
Party Name:PARAMOUNT AROMACHEM PVT.LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01129/AM16/
RLA File :05/24/040/00235/AM16/
Lic.No/Date:0510395245 07.08.2015 Defer Date:27.01.2016

314

Case No.:68/13/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01031/AM16/
RLA File :05/24/040/00230/AM16/
Lic.No/Date:0510395244 07.08.2015 Defer Date:27.01.2016

315

Case No.:107/13/82-

ALC4/2015
Party Name:DANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01070/AM16/
RLA File :03/94/040/00299/AM16/
Lic.No/Date:0310798050 10.08.2015 Defer Date:27.01.2016

316

Case No.:6/13/82-ALC4/2015 Party Name:CLEAN

SCIENCE AND TECHNOLOGY PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00969/AM16/
RLA File :31/83/040/00066/AM16/
Lic.No/Date:3110065596 12.08.2015 Defer Date:27.01.2016

317

Case No.:110/13/82-

ALC4/2015
Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01073/AM16/
RLA File :03/94/040/00350/AM16/
Lic.No/Date:0310798096 12.08.2015 Defer Date:27.01.2016 Decision : The Committee based on the written comments forwarded by the D/o C&PC, 14010/96/2011-Ch-II dated 30.12.2015 , uploaded along with these minutes decided to

call for technical information from the firm and deferred the case.

318

Case No.:106/13/82-

ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01069/AM16/
RLA File :03/94/040/00379/AM16/
Lic.No/Date:0310798101 12.08.2015 Defer Date:27.01.2016

319

Case No.:111/13/82-

ALC4/2015
Party Name:HEMA DYE CHEM PVT. LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01074/AM16/
RLA File :03/94/040/00305/AM16/
Lic.No/Date:0310798134 13.08.2015 Defer Date:27.01.2016 Decision : The Committee based on the written comments forwarded by the D/o C&PC, 14010/86/2015-Ch-II dated 30.12.2015 , uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

320

Case No.:91/13/82-

ALC4/2015
Party Name:VENUS REMEDIES LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01054/AM16/
RLA File :22/24/040/00016/AM16/
Lic.No/Date:2210015282 13.08.2015 Defer Date:27.01.2016

321

Case No.:79/13/82-

ALC4/2015
Party Name:AMI ORGANICS PVT LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01042/AM16/
RLA File :52/24/040/00034/AM16/
Lic.No/Date:5210041610 14.08.2015 Defer Date:27.01.2016

322

Case No.:57/13/82-

ALC4/2015
Party Name:VENUS REMEDIES LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01020/AM16/
RLA File :22/24/040/00013/AM16/
Lic.No/Date:2210015284 14.08.2015 Defer Date:27.01.2016

323

Case No.:52/13/82-

ALC4/2015
Party Name:ARGO BIOCHEM PRIVATE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01015/AM16/
RLA File :03/94/040/00300/AM16/
Lic.No/Date:0310798204 17.08.2015 Defer Date:27.01.2016

324

Case No.:127/13/82-

ALC4/2015
Party Name:ASTEC LIFESCIENCES LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01090/AM16/
RLA File :03/94/040/00878/AM15/
Lic.No/Date:0310798205 17.08.2015 Defer Date:27.01.2016

325

Case No.:60/13/82-

ALC4/2015
Party Name:HELLO PAINTS (P) LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01023/AM16/
RLA File :05/23/040/00204/AM16/
Lic.No/Date:0510395351 18.08.2015 Defer Date:27.01.2016

326

Case No.:90/13/82-

ALC4/2015
Party Name:INDO PHYTO CHEMICALS PVT LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01053/AM16/
RLA File :05/23/040/00195/AM16/
Lic.No/Date:0510395344 18.08.2015 Defer Date:27.01.2016

327

Case No.:65/13/82-ALC4/2015 Party Name:PAYAL

PETROCHEM PRIVATE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01028/AM16/
RLA File :05/24/040/00149/AM16/
Lic.No/Date:0510395338 18.08.2015 Defer Date: D/o C&PC, U.O.No.14010/18/2014-Ch-II dated 2.9.2015, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA

328

Case No.:66/13/82-ALC4/2015 Party Name:PAYAL

PETROCHEM PRIVATE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01029/AM16/
RLA File :05/24/040/00118/AM16/
Lic.No/Date:0510395337 18.08.2015 Defer Date: D/o C&PC, U.O.No.14010/18/2014-Ch-II dated 2.9.2015, uploaded along with these

329

Case No.:67/13/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01030/AM16/
RLA File :05/24/040/00172/AM16/
Lic.No/Date:0510395339 18.08.2015 Defer Date:27.01.2016

D/o C&PC, U.O.No.14010/18/2014-Ch-II dated 2.9.2015, uploaded along with these

330

Case No.:89/13/82-

ALC4/2015
Party Name:INDO PHYTOCHEM PHARMACEUTICALS Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01052/AM16/
RLA File :05/23/040/00211/AM16/
Lic.No/Date:0510395366 19.08.2015 Defer Date:27.01.2016

331

Case No.:59/13/82-ALC4/2015 Party Name:PAYAL

PETROCHEM PRIVATE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01022/AM16/
RLA File :05/24/040/00605/AM15/
Lic.No/Date:0510395358 19.08.2015 Defer Date: D/o C&PC, U.O.No.14010/18/2014-Ch-II dated 2.9.2015, uploaded along with these

332

Case No.:63/13/82-ALC4/2015 Party Name:PAYAL

PETROCHEM PRIVATE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01026/AM16/
RLA File :05/24/040/00606/AM15/
Lic.No/Date:0510395359 19.08.2015 Defer Date: D/o C&PC, U.O.No.14010/18/2014-Ch-II dated 2.9.2015, uploaded along with these

333

Case No.:64/13/82-ALC4/2015 Party Name:PAYAL

PETROCHEM PRIVATE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01027/AM16/
RLA File :05/24/040/00618/AM15/
Lic.No/Date:0510395374 19.08.2015 Defer Date: D/o C&PC, U.O.No.14010/18/2014-Ch-II dated 2.9.2015, uploaded along with these

334

Case No.:87/13/82-ALC4/2015 Party Name:PAYAL

PETROCHEM PRIVATE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01050/AM16/
RLA File :05/24/040/00612/AM15/
Lic.No/Date:0510395362 19.08.2015 Defer Date:

D/o C&PC, U.O.No.14010/18/2014-Ch-II dated 2.9.2015, uploaded along with these

335

Case No.:88/13/82-ALC4/2015 Party Name:PAYAL

PETROCHEM PRIVATE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01051/AM16/
RLA File :05/24/040/00025/AM16/
Lic.No/Date:0510395364 19.08.2015 Defer Date: D/o C&PC, U.O.No.14010/18/2014-Ch-II dated 17.12.2015, uploaded along with these

336

Case No.:126/13/82-

ALC4/2015
Party Name:ASTEC LIFESCIENCES LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01089/AM16/
RLA File :03/94/040/00879/AM15/
Lic.No/Date:0310798319 20.08.2015 Defer Date:27.01.2016

337

Case No.:61/13/82-

ALC4/2015
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01024/AM16/
RLA File :05/23/040/00218/AM16/
Lic.No/Date:0510395388 20.08.2015 Defer Date:27.01.2016

338

Case No.:62/13/82-

ALC4/2015
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01025/AM16/
RLA File :05/23/040/00212/AM16/
Lic.No/Date:0510395383 20.08.2015 Defer Date:27.01.2016

339

Case No.:72/13/82-

ALC4/2015
Party Name:AMI ORGANICS PVT LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01035/AM16/
RLA File :52/24/040/00036/AM16/
Lic.No/Date:5210041615 21.08.2015 Defer Date:27.01.2016

340

Case No.:161/13/82-

ALC4/2015
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File RLA File Lic.No/Date:0310798374 Defer

:01/82/050/01124/AM16/
:03/95/040/00274/AM16/
21.08.2015 Date:27.01.2016

341

Case No.:125/13/82-

ALC4/2015
Party Name:FDC LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01088/AM16/
RLA File :03/94/040/00364/AM16/
Lic.No/Date:0310798396 24.08.2015 Defer Date:27.01.2016

342

Case No.:130/13/82-

ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01093/AM16/
RLA File :03/94/040/00413/AM16/
Lic.No/Date:0310798392 24.08.2015 Defer Date:27.01.2016

343

Case No.:85/13/82-

ALC4/2015
Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01048/AM16/
RLA File :05/23/040/00198/AM16/
Lic.No/Date:0510395430 25.08.2015 Defer Date:27.01.2016

344

Case No.:86/13/82-

ALC4/2015
Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01049/AM16/
RLA File :05/23/040/00200/AM16/
Lic.No/Date:0510395431 25.08.2015 Defer Date:27.01.2016

345

Case No.:54/13/82-

ALC4/2015
Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01017/AM16/
RLA File :03/94/040/00089/AM16/
Lic.No/Date:0310798493 26.08.2015 Defer Date:27.01.2016

346

Case No.:129/13/82-

ALC4/2015
Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01092/AM16/
RLA File :03/94/040/00336/AM16/
Lic.No/Date:0310798491 26.08.2015 Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/659/2012-PI(Norms) dated 12.3.2013, uploaded along with these minutes or as applied by the firm whichever is

decision of NC.

347

Case No.:77/13/82-

ALC4/2015
Party Name:ARKRAY HEALTHCARE PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01040/AM16/
RLA File :52/24/040/00038/AM16/
Lic.No/Date:5210041620 27.08.2015 Defer Date:27.01.2016 Decision : The Committee decided to defer the case for want of comments of DOP.

348

Case No.:121/13/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01084/AM16/
RLA File :03/94/040/00406/AM16/
Lic.No/Date:0310798528 27.08.2015 Defer Date:27.01.2016 Decision : Requisite information has been received and sent to DoP for comments.

349

Case No.:122/13/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01085/AM16/
RLA File :03/94/040/00408/AM16/
Lic.No/Date:0310798530 27.08.2015 Defer Date:27.01.2016 Decision : Requisite information has been received and sent to DoP for comments.

350

Case No.:74/13/82-ALC4/2015 Party Name:KLJ

PLASTICIZERS LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01037/AM16/
RLA File :05/23/040/00201/AM16/
Lic.No/Date:0510395469 28.08.2015 Defer Date: D/o C&PC, U.O.No.14010/36/2011-Ch-II dated 21.12.2015, uploaded along with these

351

Case No.:128/13/82-

ALC4/2015
Party Name:ALKYL AMINES CHEMICALS LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01091/AM16/
RLA File :03/94/040/01129/AM15/
Lic.No/Date:0310798586 31.08.2015 Defer Date:27.01.2016

352

Case No.:123/13/82-

ALC4/2015
Party Name:GUJARAT ORGANICS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File RLA File Lic.No/Date:0310798598 Defer Date:

:01/82/050/01086/AM16/
:03/94/040/00247/AM16/
01.09.2015 D/o C&PC, U.O.No.14010/11/2013-Ch-II dated 01.01.2016, uploaded along with these

353

Case No.:124/13/82-

ALC4/2015
Party Name:GUJARAT ORGANICS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01087/AM16/
RLA File :03/94/040/00246/AM16/
Lic.No/Date:0310798597 01.09.2015 Defer Date:27.01.2016

354

Case No.:120/13/82-

ALC4/2015
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01083/AM16/
RLA File :03/94/040/00279/AM16/
Lic.No/Date:0310798629 03.09.2015 Defer Date:27.01.2016

355

Case No.:96/13/82-

ALC4/2015
Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01059/AM16/
RLA File :31/83/040/00080/AM16/
Lic.No/Date:3110065626 08.09.2015 Defer Date:27.01.2016

356

Case No.:7/9/82-ALC4/2015 Party Name:DR REDDYS

Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00943/AM16/
RLA File :09/24/040/00312/AM16/
Lic.No/Date:0910062574 08.09.2015 Defer Date:27.01.2016

357

Case No.:3/9/82-ALC4/2015 Party Name:HETERO

DRUGS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00939/AM16/
RLA File :09/24/040/00341/AM16/
Lic.No/Date:0910062565 08.09.2015 Defer Date:27.01.2016

358

Case No.:4/9/82-ALC4/2015 Party Name:HETERO

DRUGS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00940/AM16/
RLA File :09/24/040/00338/AM16/
Lic.No/Date:0910062566 08.09.2015 Defer Date:27.01.2016

359

Case No.:5/9/82-ALC4/2015 Party Name:HETERO

DRUGS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00941/AM16/
RLA File :09/24/040/00337/AM16/
Lic.No/Date:0910062567 08.09.2015 Defer Date:27.01.2016

360

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

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00938/AM16/
RLA File :09/24/040/00344/AM16/
Lic.No/Date:0910062564 08.09.2015 Defer Date:27.01.2016

361

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

CHEM PVT. LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00944/AM16/
RLA File :34/24/040/00155/AM16/
Lic.No/Date:3410041496 09.09.2015 Defer Date:27.01.2016

362

Case No.:10/9/82-ALC4/2015 Party Name:ALKYL

AMINES CHEMICALS LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00946/AM16/
RLA File :03/94/040/00355/AM16/
Lic.No/Date:0310798806 10.09.2015 Defer Date:27.01.2016

363

Case No.:170/13/82-

ALC4/2015
Party Name:VINDHYA ORGANICS PVT LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01133/AM16/
RLA File :09/24/040/00358/AM16/
Lic.No/Date:0910062596 11.09.2015 Defer Date:27.01.2016

364

Case No.:12/9/82-ALC4/2015 Party Name:ALKYL

AMINES CHEMICALS LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00948/AM16/
RLA File :03/94/040/00372/AM16/
Lic.No/Date:0310798878 14.09.2015 Defer Date:27.01.2016

365

Case No.:16/9/82-ALC4/2015 Party Name:ALKYL

AMINES CHEMICALS LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00952/AM16/
RLA File :03/94/040/00265/AM16/
Lic.No/Date:0310798923 16.09.2015 Defer Date:27.01.2016

366

Case No.:18/9/82-ALC4/2015 Party Name:HETERO LABS

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00954/AM16/
RLA File :09/24/040/00368/AM16/
Lic.No/Date:0910062629 16.09.2015 Defer Date:27.01.2016

367

Case No.:19/9/82-ALC4/2015 Party Name:HETERO LABS

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00955/AM16/
RLA File :09/24/040/00369/AM16/
Lic.No/Date:0910062630 16.09.2015 Defer Date:27.01.2016

368

Case No.:17/9/82-ALC4/2015 Party Name:HONOUR LAB

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00953/AM16/
RLA File :09/24/040/00371/AM16/
Lic.No/Date:0910062628 16.09.2015 Defer Date:27.01.2016

369

Case No.:20/9/82-ALC4/2015 Party Name:SUPREET

CHEMICALS PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00956/AM16/
RLA File :03/95/040/00424/AM16/
Lic.No/Date:0310798995 22.09.2015 Defer Date:27.01.2016

370

Case No.:4/13/82-ALC4/2015 Party Name:AUROBINDO

PHARMA LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00967/AM16/
RLA File :09/24/040/00391/AM16/
Lic.No/Date:0910062720 13.10.2015 Defer Date:27.01.2016

371

Case No.:3/13/82-ALC4/2015 Party Name:HETERO

DRUGS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00966/AM16/
RLA File :09/24/040/00432/AM16/
Lic.No/Date:0910062716 13.10.2015 Defer Date:27.01.2016

372

Case No.:1/13/82-ALC4/2015 Party Name:HETERO LABS

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred

HQ File :01/82/050/00964/AM16/
RLA File :09/24/040/00435/AM16/
Lic.No/Date:0910062713 13.10.2015 Defer Date:27.01.2016

373

Case No.:2/13/82-ALC4/2015 Party Name:HETERO LABS

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/00965/AM16/
RLA File :09/24/040/00436/AM16/
Lic.No/Date:0910062714 13.10.2015 Defer Date:27.01.2016

374

Case No.:135/13/82-

ALC4/2015
Party Name:MYLAN Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01098/AM16/
RLA File :09/24/040/00408/AM16/
Lic.No/Date:0910062740 14.10.2015 Defer Date:27.01.2016

375

Case No.:136/13/82-

ALC4/2015
Party Name:ATUL LIMITED, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01099/AM16/
RLA File :08/24/040/00207/AM16/
Lic.No/Date:0810136320 16.10.2015 Defer Date:27.01.2016

376

Case No.:138/13/82-

ALC4/2015
Party Name:ARCHIMEDIS LABORATORIES PVT. LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01101/AM16/
RLA File :09/24/040/00320/AM16/
Lic.No/Date:0910062756 20.10.2015 Defer Date:27.01.2016

377

Case No.:137/13/82-

ALC4/2015
LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01100/AM16/
RLA File :09/24/040/00450/AM16/
Lic.No/Date:0910062755 20.10.2015 Defer Date:27.01.2016

378

Case No.:139/13/82-

ALC4/2015
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01102/AM16/
RLA File :03/95/040/00456/AM16/
Lic.No/Date:0310799558 20.10.2015 Defer Date: D/o C&PC U.O.No.14010/62/2010-CH-II dated 19.10.2015, uploaded along with these

379

Case No.:140/13/82-

ALC4/2015
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01103/AM16/
RLA File :03/95/040/00503/AM16/
Lic.No/Date:0310799583 21.10.2015 Defer Date:27.01.2016

380

Case No.:168/13/82-

ALC4/2015
Party Name:SYNERGENE ACTIVE INGREDIENTS PVT LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01131/AM16/
RLA File :09/24/040/00426/AM16/
Lic.No/Date:0910062765 21.10.2015 Defer Date:27.01.2016

381

Case No.:141/13/82-

ALC4/2015
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01104/AM16/
RLA File :03/95/040/00504/AM16/
Lic.No/Date:0310799629 23.10.2015 Defer Date:27.01.2016

382

Case No.:142/13/82-

ALC4/2015
Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01105/AM16/
RLA File :09/24/040/00443/AM16/
Lic.No/Date:0910062774 27.10.2015 Defer Date:27.01.2016

383

Case No.:144/13/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01107/AM16/
RLA File :09/24/040/00387/AM16/
Lic.No/Date:0910062780 28.10.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/536/2015-PI(Norms) dated decision of NC.

384

Case No.:145/13/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File RLA File Lic.No/Date:0910062781 Defer

:01/82/050/01108/AM16/
:09/24/040/00396/AM16/
28.10.2015 Date:27.01.2016

385

Case No.:146/13/82-

ALC4/2015
Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01109/AM16/
RLA File :09/24/040/00413/AM16/
Lic.No/Date:0910062785 28.10.2015 Defer Date:27.01.2016

386

Case No.:143/13/82-

ALC4/2015
Party Name:HETERO DRUGS LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01106/AM16/
RLA File :09/24/040/00457/AM16/
Lic.No/Date:0910062776 28.10.2015 Defer Date:27.01.2016

387

Case No.:147/13/82-

ALC4/2015
Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01110/AM16/
RLA File :08/24/040/00241/AM16/
Lic.No/Date:0810136382 29.10.2015 Defer Date:27.01.2016

388

Case No.:148/13/82-

ALC4/2015
LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01111/AM16/
RLA File :09/24/040/00465/AM16/
Lic.No/Date:0910062798 29.10.2015 Defer Date:27.01.2016

389

Case No.:149/13/82-

ALC4/2015
LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01112/AM16/
RLA File :09/24/040/00466/AM16/
Lic.No/Date:0910062799 29.10.2015 Defer Date:27.01.2016

390

Case No.:150/13/82-

ALC4/2015
LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01113/AM16/
RLA File :09/24/040/00467/AM16/
Lic.No/Date:0910062800 29.10.2015 Defer Date:27.01.2016

391 Case No.:152/13/82- ALC4/2015
Party Name:ARCHIMEDIS LABORATORIES PVT. LTD. Meet No/Date:15/82- ALC4/2015 Status:Case Deferred

30.12.2015 HQ File :01/82/050/01115/AM16/
RLA File :09/24/040/00319/AM16/
Lic.No/Date:0910062806 30.10.2015 Defer Date:27.01.2016

392

Case No.:153/13/82-

ALC4/2015
Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01116/AM16/
RLA File :34/24/040/00199/AM16/
Lic.No/Date:3410041644 02.11.2015 Defer Date:27.01.2016

393

Case No.:154/13/82-

ALC4/2015
Party Name:DR REDDYS Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01117/AM16/
RLA File :09/24/040/00460/AM16/
Lic.No/Date:0910062821 03.11.2015 Defer Date:27.01.2016

394

Case No.:155/13/82-

ALC4/2015
LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01118/AM16/
RLA File :09/24/040/00475/AM16/
Lic.No/Date:0910062827 03.11.2015 Defer Date:27.01.2016

395

Case No.:156/13/82-

ALC4/2015
Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01119/AM16/
RLA File :09/24/040/00464/AM16/
Lic.No/Date:0910062832 03.11.2015 Defer Date:27.01.2016

396

Case No.:159/13/82-

ALC4/2015
Party Name:CHEMCON SPECIALITY CHEMICALS P LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01122/AM16/
RLA File :34/24/040/00205/AM16/
Lic.No/Date:3410041650 04.11.2015 Defer Date:27.01.2016

397

Case No.:157/13/82-

ALC4/2015
LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01120/AM16/
RLA File :09/24/040/00476/AM16/
Lic.No/Date:0910062833 04.11.2015 Defer Date:27.01.2016

398

Case No.:158/13/82-

ALC4/2015
LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01121/AM16/
RLA File :09/24/040/00477/AM16/
Lic.No/Date:0910062834 04.11.2015 Defer Date:27.01.2016

399

Case No.:163/13/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01126/AM16/
RLA File :09/24/040/00479/AM16/
Lic.No/Date:0910062838 06.11.2015 Defer Date:27.01.2016

400

Case No.:162/13/82-

ALC4/2015
Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01125/AM16/
RLA File :09/24/040/00427/AM16/
Lic.No/Date:0910062836 06.11.2015 Defer Date:27.01.2016

401

Case No.:165/13/82-

ALC4/2015
Party Name:ATUL LIMITED, Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01128/AM16/
RLA File :52/24/040/00050/AM16/
Lic.No/Date:5210041688 12.11.2015 Defer Date:27.01.2016

402

Case No.:167/13/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01130/AM16/
RLA File :09/24/040/00493/AM16/
Lic.No/Date:0910062862 19.11.2015 Defer Date:27.01.2016

403

Case No.:171/13/82-

ALC4/2015
Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Approved HQ File :01/82/050/01134/AM16/
RLA File :09/24/040/00497/AM16/
Lic.No/Date:0910062889 24.11.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/538/2013-PI(Norms) dated 26.09.2013, uploaded along with these minutes or as applied by the firm whichever is decision of NC.

404

Case No.:171/14/82-

ALC4/2015
Party Name:ALKYL AMINES CHEMICALS LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01307/AM16/
RLA File :03/94/040/00533/AM16/
Lic.No/Date:0310800496 30.11.2015 Defer Date:27.01.2016

405

Case No.:1/15/82-ALC4/2015 Party Name:HETERO LABS

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01312/AM16/
RLA File :09/24/040/00529/AM16/
Lic.No/Date:0910062940 08.12.2015 Defer Date:27.01.2016

406

Case No.:2/15/82-ALC4/2015 Party Name:HETERO LABS

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01313/AM16/
RLA File :09/24/040/00538/AM16/
Lic.No/Date:0910062945 08.12.2015 Defer Date:27.01.2016

407

Case No.:5/15/82-ALC4/2015 Party

Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01316/AM16/
RLA File :34/24/040/00215/AM16/
Lic.No/Date:3410041722 10.12.2015 Defer Date:27.01.2016

408

Case No.:3/15/82-ALC4/2015 Party Name:HETERO LABS

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01314/AM16/
RLA File :09/24/040/00553/AM16/
Lic.No/Date:0910062954 10.12.2015 Defer Date:27.01.2016

409

Case No.:4/15/82-ALC4/2015 Party Name:HETERO LABS

LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01315/AM16/
RLA File :09/24/040/00545/AM16/
Lic.No/Date:0910062955 10.12.2015 Defer Date:27.01.2016

410

Case No.:6/15/82-ALC4/2015 Party Name:AUROBINDO

PHARMA LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01317/AM16/
RLA File :09/24/040/00540/AM16/
Lic.No/Date:0910062982 17.12.2015 Defer Date:27.01.2016

411

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

PHARMA LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01318/AM16/
RLA File :09/24/040/00531/AM16/
Lic.No/Date:0910062983 17.12.2015 Defer Date:27.01.2016

412

Case No.:8/15/82-ALC4/2015 Party Name:AUROBINDO

PHARMA LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01319/AM16/
RLA File :09/24/040/00536/AM16/
Lic.No/Date:0910062985 17.12.2015 Defer Date:27.01.2016

413

Case No.:9/15/82-ALC4/2015 Party Name:AUROBINDO

PHARMA LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01320/AM16/
RLA File :09/24/040/00530/AM16/
Lic.No/Date:0910062986 17.12.2015 Defer Date:27.01.2016

414

Case No.:52/15/82-

ALC4/2014
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:15/82- ALC4/2015 30.12.2015 Status:Case Deferred HQ File :01/82/050/01339/AM15/
RLA File :09/24/040/00408/AM15/
Lic.No/Date:0910061280 20.11.2014 Defer Date:27.01.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.35011/228/2015-PI(Norms) dated oct.2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

Manual Agenda of NC Meeting No.15/82/2015 Scheduled to be held on 30.12.2015 but actually held on 07.01.2016

Case No. B- 01

M.No.15/AM-16 Date 30.12.2015

M/s. SMB Corporation Of India File No. 01/82/050/01016/AM 13 RLA No.03/95/040/00568/AM 13 Adv.Auth. No. 0310713614 dated. 25.10.2012

Decision: The Committee considered this case for amendment in the UOM of export product as per agenda. The Committee decided to defer the case for want of comments of DCPC.

Case No. B- 02

M.No.15/AM-16 Date 30.12.2015

M/s. Pharmazell (India) Pvt Ltd File No. 01/82/162/00138/AM 15

Decision: The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/234/2015-PI(Norms) dated 17.12.2015 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of

Case No. B- 03

M.No.15/AM-16 Date 30.12.2015

M/s. DSM Sinochem Pharmaceuticals India Pvt Ltd File No. 01/82/050/00152/AM 07 RLA No. 22/24/040/00152/AM07 Adv Auth No. 2210005831 dated 31.07.2006

Decision: The committee considered the case for correction/revision of norms as per agenda.
The Committee decided to defer the case for want of comments of DoP.

Case No. B- 04

M.No.15/AM-16 Date 30.12.2015

File No. 01/82/050/00056/AM 08 RLA No. 22/21/042/00006/AM05 Adv Auth No. 2210006467 dated 02.02.2007

Decision: The committee considered the case for correction/revision of norms as per agenda.
The Committee decided to defer the case for want of comments of DoP.

Case No. B- 05

M.No.15/AM-16 Date 30.12.2015

File No. 01/82/050/00254/AM 08 RLA No. 22/24/040/00008/AM08 Adv Auth No. 2210006706 dated 03.05.2007

Decision: Decision: The committee considered the case for correction/revision of norms as per agenda. The Committee decided to defer the case for want of comments of DoP.

Case No. B- 06

M.No.15/AM-16 Date 30.12.2015

File No. 01/82/050/00869/AM 08 RLA No. 22/24/040/00020/AM08 Adv Auth No. 2210006928 dated 31.07.2007

Case No. B- 07

M.No.15/AM-16 Date 30.12.2015

File No. 01/82/050/00542/AM 08 RLA No. 22/24/040/00016/AM08 Adv Auth No. 2210006807 dated 18.06.2007

Case No. B- 08

M.No.15/AM-16 Date 30.12.2015

File No. 01/82/050/00410/AM 08 RLA No. 22/24/040/00010/AM08 Adv Auth No. 2210006746 dated 28.06.2007

Case No. B- 09

M.No.15/AM-16 Date 30.12.2015

File No. 01/82/050/01244/AM 12 RLA No. 22/24/040/00071/AM12 Adv Auth No. 2210012378 dated 29.12.2011

Case No. B- 10

M.No.15/AM-16 Date 30.12.2015

File No. 01/82/050/01155/AM 12 RLA No. 22/24/040/00061/AM12 Adv Auth No. 2210012197 dated 22.11.2011

Case No. B- 11

M.No.15/AM-16 Date 30.12.2015

File No. 01/82/050/00970/AM 11 RLA No. 22/24/040/00022/AM11 Adv Auth No. 2210010238 dated 04.08.2010

Case No. B- 12

M.No.15/AM-16 Date 30.12.2015

File No. 01/82/050/00253/AM 08 RLA No. 22/24/040/00007/AM08 Adv Auth No. 221006705 dated 03.05.2007

151め “ ‐に s.yo.?9 F. No 3501 1/409/2014-PI (Norms) Govemment of India Ministry of Chemical & Fertilizers DePartment of Pharmaceuticals UdYog Bhawan, New Delhi, the January, 2015 Office Memorandum Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol l) 2009- l4 Case of M/s. Emcure Pharma Ltd' l'he r.rndersigned is directed to refer to DGFT II O'No' 01i82/i0/349i,/LM 15/:DES-3/414 dated the 08/05/14 vide which an application -,i, U'r. E,mcLrre Pharma Ltd ''as sent to this Depanment for fixation of norms ;;;;;;; i.z tbr the export of Fomepizole rni€ction vial l'Sgm/ml 'l'his a"ror,n]"n, has examined the tna er and ihe following co[unents are fumished '.rnder firrx +.7 ol t land Book of Proccdures ( Vol l) 200q- l4:- Ihis issues with the approval ofDirector (Pl)' (Rai Kumar) Under Secretary to the Govemment oflndia Directorirte General of Foreign Trade, I)epartrne[t ol Commerce, (Ski Nl.v. Singh, FTDO), Ud-Yog Bhawan, New Delhi l.65gm/vial of 1.5rnl

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I t l/r4-tl sy:7 F. No.350l I /43712014-PI (Norms) Govemment of India Department ol Pharmaceuticals Nc、v Delhi the Udyog Bhawan. February, 2015 Office Memorandum Sub: l'ixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s. Unimax Chemicals Pvt Ltd. 'l'hc undersigned is directed to ret'er to DGl"'f U.O.No. 0l /82/50/170/AM l5/DES-3/,+51 dated the l0/07l14 vide which an application tiorn M/s. tJnirnax Cherricals Pvt Ltd was sent to this Departrr.rent fbr fixation of norrns under para: 4.7 tbr the export of Azithromycin Motrohydrate USP. This dcpartment has examined the matter and the following comn.lents are lurnished undcr para .1.7 ol'Hand Book of Procedures (Vol.l) 2009- l4:- S. No. Import Itern Qty. Recommended kg/kg. l Azithromycin Dihydrate 1.05 つ This issucs with the approval ofDirector (PI). (Raj Kumar) Phone- 23071162 Dircctorate General of Foreign Trade, Department of Commerce. (Shri M.V. Singh, F'|DO), Udyog Bhawan, New Delhi

Subject: M/s. Atul Ltd. have submitted present apptications for the import ol raw material against the export Chloro lrethyl lsopropyl Carbonate. The applicatron has been examined and the Department recommends the following norms for the presentAdvance Authorlzation applicalions 151みあ―′ι Government of lndia Ministry of Chemicals and Fertilizers Department of Chemicals and Petrochemicals 9イハら,『フ= Advance Authorization application lrom M/s. Atul Ltd' for the imporl of raw material against the export of Chloro Methyl lsopropyl Carbonate' This issues with the approval of competent authority Deptt of C&PC N o--'t 40 to/1 6/20 1 5€H-l I dated l 11 I 2 20 1 5 / (Advance Authorization No. 5210041063 dated 23 5 2014 ) Cfrtoro Methyl lsopropyl Carbonate. ヽスゞ (A K AGARWAL) Addl lndustrial AdviSer Tel No 011‐ 23381430

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lr. No.i50l 1r592/1015-l'l (Nolms) Gor clnnrcnt o1'lnclia \liri:trr ol t lrr'rtiirl & lrcltilrzcr': I)cl)urlDlcnt ol' l'lranr]accLlticnls LJdyog Blrawan, Ncw Dclhi thc Jarua+t+{}+6 L &z'. lnt f Office Mcmorandum Subject; - Fixation of norms under para 4.7 ol'Hand Book of Procedures (Vol.l) ?009-14 Case of M/s Dr.J. I)harrnachcrn( India) The undersigned is dilected to rel'el to DGFT U.O.No 0l/tt2l050/00642/AM- l6lDLS-l/764 dated the l0/08/15 vidc which application ti'om M/s Dr.J. Pharmachcm(lndia). was scnt to this Dcpaftment lor fixation of nortns undcr para: 4.7 lor the expon of sodium benzoatc micronised. This dePartment has cxatnincd the rratter Expofl product is stated to be used as additive to resin & polymers and havc no pharmaceutical usc. 2.'l his issues with the approval ol'conlpetent authority. ( Itaj Kumar) Under Secretary to the Govemment o1' lndia t'hone:21071 I 62 Dircctoratc General ol'f oreign Tradc, Dcpartment of Commcrce, (Shri M.V. Singh, FTDO). Udyog Bhawan, New Dclhi 9.a. e*

Government ot lndie Ministry of Chemicals and Fertilizers Department of Chemicals and Petrochemicals g^/。∫ァ Sublect: Advance AuthonzatiOn app calon from M/s Mang am Organics Ltd forthe impoft ofraw mateHalaga nstthe export of SODIUM ACETATE(TRIHYDRATE) Ref: UO No 01′82′05071025/AM15/DES‐ l‖′1224 dated 3 3 2015 M/s. Manglam Organics Ltd. have submitted present applications for the import of raw mateial against the export of soDtuM ACETATE (TRtHyDFiATE) The application have been examined and the Department recommends the following norms for the present Advance Authorization applications.

ltem of Export Qty Item of lmDorl Qty SODIUM ACETATE(TRIHYDRATE) l kg ACETIC ACID 0500 kg CAuSTIC soDA 0 590 kg This issues with the approval of competent authority. Addl industria:Adviser TeI No 0112338 1430 Sh“ Mahender Vikram Sinoh FTDO(DESJ‖ )0′o DGFT Udvoo Bhawan NeW Delhi-11 Deptt Of C&PC U O No 14010′ 14′2015‐CH‐‖dated 15 12 2015 (A K AGARヽVAL)

t<lr7!n-)b ,4> g/.N":2 F. No.350l l/29,1/20 | 5-PI (Norms) Government of lndia Ministry ofChemical & Fertilizers Department of Pharmaceulicals tldyog Bhawan, New Delhi. the October. 2015 Of'fice Memorandum

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

of M/s Jubilant Cenerics Ltd. 'l he undersigned is directed to refer to DCFT U.O.No. 0l/82/50/24lAM- I6/DES-3/54 daled the I2l05/15 vide which application tiom M/s. Jubilant Cenerics Ltd was sent to this l)eparlment lor fixation ofnorms under para: 4-7 tbr the export ofAtorvastatin Tablets 5mg and lomg. This department has examined the matter and it is requested thal DGF I may call loll,rrr in! tcehnical derails lrom lhc firm \ r./:- (a) Copy of DML for the above export item. (b) Master-Batch Formula duly certified by Quality-Control Incharge for the new formula stated in the application. (Raj Kumar) Undcr Secretary to ihe Covernment oflndia Phone;23071162 Directorate General of Foreign Trade. Department of Commerce, (Shri M.V. Singh. f 1'DO), tJdl-og Bhawan. Neu, Delhi

I q )bA-\b F. No.350l l/l l412015-PI (Norms) Covernment oflndia Ministry of Chcmicals & Ferlilizers Department of Pharmaceulicals Sl tlo' 8" Udyog Bhawan,New Delhi, Dated the Seplember. 2015 Office Memorandum Subiect: - Fixation of norms under para 4.7 of Hand Book of procedures (Vol.1) 2009- 14 Case of M/s BDR Pharma Intemational P,1 l-td. The undersigned is directed to refer to DCFT U.O.No. 0l/82l50/l 179lAM-t5/DES- 3/1243 dated the 03/03/15 vide which applicarion from M/s. BDR pharma Inrernarional pvt Ltd was senl to this Depanment for fixation ofnorms under para: 4.? for the expon ofMeropenem l000mg and S(Xlmg Powder for Solution for Injection. This departmenl has examined the matler and the lollowing norms are fumished under para 4.7 of Hand Book of procedures l Vol.l) 2009-14:- ncm Trihydrate + Sodium Carbonate l255.0lmg/lgm vial And 627.505mg/500mg vial (Bamali Khastgir) Under Secretary to the (;ovemment ol'lndia Phoner210Tl162 Dircctorale (;cneral of Foreign Trade. Depanment ofCommerce, (Shri M.v. Singh. FTDO), lmport Item Qly. Recommended. ls

,rl,--'n ダダ F No 35011/54712015-PI oヽ011`lS) Govcrnmcnt ofindia Ministry orchcmical&ドcrtinzcrs Dcpart:llcnt orPharmaccuticals Udyog Bhawan, New Delhi. the December.20l5 Olfice Memorandum Subjcct: - Fixation ofnorms under para 4.7 ofHand Book of Procedures (Vol l) 2009-14 Case ol M/s Hetero Labs Ltd. The undersigned is directed to ref'er to DCFT tl.O.No. 0l /82/50/35/AM- l6/DES-3/826 ddled the 27108/15 vide which application liom M/s. Hetero Labs Lld was sent to this Department for fixation of noms under para: 4.7 for the cxport of Bicalutamide. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book ofProcedures (Vol.l) 2009-1,1:- S No Lnport Itenr Qtl-. Recommended kg/kg. | ,l Anrino-l-Trilluoro Methyl-Bcnzonitrile 0533 P-Fluoro Thiophenol 030 , Tctrahydrofuran 1 04 2. lhis issues with thc approval ofcompetenl authorily. (Raj K umar) [-]nder Secretary to the Government oflndia Phone:23071162 Directorate (lcneral oI loreign Trade. Dcpartmcnt of Commerce. (Shri M.V. Singh. FTDO), Lldyog Bharvan. New Delhi

''- ; -t' L No.-l50l l 175/1015-l,l (Nonns) (io\cltnteDt ol lndia Ministn ol ( herrical & Irertilizt,rs I )cparlnrcnl ol' Phaollitceulicals

lJdyog Bhawan. New Delhi, rhe lA Decernber. 2015 Ollice Memorandunr

Subject: - Fixation ol'nornrs under para 4.7 ofHand Book ofPtocedures (Vol.l) 2009-J,l Case

ofM/s Amol Pharnra Pvt Ltd. 'lhe undersigned is directed k) reler to DGFT tJ.O.No. 0l/82/50/l I07lAM-1s/DES- l/620 daled the 20/07/15 vidc whiclr application from M/s. Amol l,harma Pvr Lrd was scnl ro lhis Department fbr fixation of noms under para: 4.7 lbr lhc cxpon of Glucosamine Hydrochloride Chondroitin Sulfate BIcnd. l'his department has examined the tualter and the lbllowing norms are lirnishcd under parr 4.7 ofHand Book oi'Procedures (Vol.l) 2009-14:- (Jn. Reeorrrrrrcldcd lg kg. ()126 ()126 0.0.11 litrkg lhis issues $ith the appto\al ol conlpetent aulhority. S/,^/"- ?S- (Rli l,umar) Under Secretary to the Covernlnent ol-lndia Phone:ll07ll6l ヽ Direcknale Geoeral of l.oreign 'frade. Depannrenl of Conrntercc. (Shri M.V. Singh. lJl l)O). Udyog llhawaD. Neu l)elhi

)ヱ F No 14010′ 164′2011‐CH‐ ll Government oflnd a Min stry of Chemicals and Fertllzers Department of Chemicals and Petrochem cals S/メる.9' Shastl Bhavan,New Delh‐ 110001 Dated:5th,」anualγ ,2016 To. Shiva Pharma Chem Ltd, PI●tNo 588, V“「Luna Tal Padra, Dist Baroda‐ 391440 Sublect:‐ Advance Authonza“ On App‖ cation for the import of rarmateHals against the expOrt of 2‐Ethyl hexanoyl Chlonde(Adv Authorizaton No 3410040655 dated 5′ 11′2014) l am d recled to「efer to your Advance AuthO「ization applicat on received thfough Office of DGFT on the sublect men‖ oned above in th s connecton,you are requested to subml the fo‖ owing inforrnat on within 1 5 days Of the issue of this letter Detailed manufacturing process, material balance with balanced chemical reactions indicating stage-wise percentage yield along with the technical justirication enclosing therewith authentic printed technical literature in support of yield or quantity of items for import. Details of production of 2-Ethyl hexanoyl Chloride and conesponding consumption of raw materials in the year 20'14-'15 and 2015-16 (April to December) duly certified by CA may be furnished. Any other relevant information. 2 1 3 (A K ACARWAL) Addl lndustr al Advise「 Tel No 011-23381430 Shri. Mahender Vikram Singh, FIDO (DES-3), in reference to DGFT/UO No― 01′82′ 050′ 01110′ AM‐ 15′DES‐‖′1401,dated 30 12 2015

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F. No.350l l/9212015-PI (Norms) Govemment of India Ministry olChemicals & Fertilizers Department of Pharmaceuticals ダん′ /。ノ Udyog Bhawan,New Delhi, Dated the September, 2015 Office Memorandum

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

2009-14 Case of M/s Virdev Intermediates Pvt Ltd. The undersigned is directed to refer ro DGFT U.O.No. 0l /82/50/tttTlAM- I5/DES-3/1093 dated the 13/01/15 vide which application from M/s. Virdev Intermediates Pvt Ltd was sent to this Department for fixation of norms under para: 4.7 lor the export of Diacerein. This department has examined the matter and it is requested that DGFT may call complete technical details liom the hrm as per Appendix-33. (Bamali Khastgir) Phone:23071 162 Directorate General of Foreign Trade, (Shri M.V. Singh, FTDO),

tq la,, ' -16 -l F. No.350 | l/425120 | 5-PI (Norms) Covernment oflndia Depanment of Pharmaceuticals e/*' /o< Udyog Bhawan. New Delhi. the December.20l5 Office Memorandum Subjecl: - l'ixation of norms under pam 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s Malladi Drugs & Pharma l-td. The undersigned is directed to refer to DGFT U.O.No.0l/82150/j3tlAM-t6/Dt:S-l/499 dated the 08/07/15 vide which application lrom M/s. Malladi Drugs & Pharma Lld was senl to this Departmcnt lbr fixation of norms under para: 4.7 for the expo( of Rac-Cis-4-Methyl-5- Penyl-2-Oxazolidinone (Rrcemic Oxazolidilone). This depanment has examined the matter and thc following norms are furnished under para 4.7 of Hand Book of procedures (Vol.l) 2009-14:- S. No. Impon kem Qty. Recommended kg,&8. 1 Itopiophcnone :.1.1 l)iclhvl Caftonale 1.00 , 7.89 | lso PropylAlcohol 191 5. 2.71 6 0.4'7 1. l'austicsoda 0.18 2. -Ihis issues wirh the approval ofcompetenl aulhority. (Raj Kumar) LJnder Secretary to the Government oflndia Phone:23071 162 Directorate General of Foreign Trade. Department ol Commerce. (Shri M.V. Singh. FTDO). tldyog Bhawan, Nerv Delhi

ι 一 “ Ａ ― ― ｌｊ ‐ ∫ F. No.350l l/21,+/2015-PI (Norms) Governmenl oJ lndia Ministry ofChemical & Fcrtilizers Udyog Bhawan, New IXlhi. the Dccember. 2015 Office Memorandum Subjectr - Fixation ofnorms under para 4.7 ofHand Book of Procedures (Vol.l) 2009-14 Case of M/s Malladi Drugs & Pharma Ltd. 'lhe undersigned is directed to refer to DGFT U.O.No. 0l/82l50/1307/AM- l s/DES- 3/l:i9l dated the I I/03/15 vide which application fiom M/s. Malladi Drugs & Pharma Ltd was scnt to this Department for fixation of norms under para: 4.7 for lhe export of (.lS,5R)-(-)4- Methyl-s-Phenyl-2-Oxazolidinone (Chiral Oxazolidinone). This department has examined the matter and the following norms are fumished under para 4.7 of lland Book of Procedures (Vol.l) 2009-14:- 2. This issues with the approval ol'competent authority. (Raj Kumar) Phoie2307 I 162 Dircctorate Ceneral of Foreign Trade, Dcpartment of Commerce, (Shri M.V. Singh. FTDO), Udyog Bhawan. New Delhi F. No.l50l l/375/201 5-PI (Norms) Covernment oflndia g/, /, l"* S, NO, Imporl llcm Qly. Recommended kg/kg | Propiophenone 5.98 , Diethvl Carbonate 0.95 lolucnc 8.90 | Iso PropylAlcohol l1 22 ヽ lleptane 6.8: 6 Methyllsobutyl Ketone ].II 1. 3.56 8 Causticsoda ],I I

To, Shastri Bhavan, New Delhi- l'10001 Dated: 7hJanuary, 2016 M/s. Lake Land Chemicals (lndia). Ltd. '101, Vasan Udyog Bhavan, Opp. Phoenix, High Street, S.B. Marg, Lower, Parel (W), lraharashtra- 40013. Sublect ApplcatiOn from M/s Lake Land Chemicals india Ltd forthe import ofraw= matenal againstthe export of LAKPOL E1 250(SORBITAN MON0 0LEATE) (Advance Authorization No 0310790966 dated 12 11 2014) I am direcled to refer to your Advance Authorization application received Irom Office of DGFT on above mentioned subject. You are being advised to submit the following information within 15 days of the issue of this letter: Detailed manufacluring process, material balance with balanced chemical reactions indacating stage-wise percentage yield along with the technical justification enclosing therewith authentic printed technical literature in support of yield or quantity of items for import. Details of production of LAKPOL El 250 (SORBITAN MONO OLEATE) and corresponding consumption of raw malerials in the year 2013-.14, 2014-15 and 2015-16 (Apral to September) duly certified by CA may be furnished. Any other relevant information ´ 11｀ぃ l= F No 14010′ 872011‐CH‐ ‖ Government of ndia Ministry of Chem ca s and Felt‖ izers Department oF Chem ca s and Petrochemica s Chem ca D vsion グ^パ Yours faithfully, Addl lndust門al Adviser Tei No 011‐23381430 in reference to DGFT/UO No‐ 30122015 2 1 ,hl Mahender Vikram, FTDO(DES■1り , 0,′ 82′ 50′01443′ AM-15′DES‐ 1′ 1391 dated .鍮諄

´ ｑノ～～。―|る F. No. 14010/8/201 1-CH-ll Government of lndia irinistry of Chemicals and Fertilizers Department of Chemicals and Petrochemicals Chemical Division `ル /// Shastri Bhavan,New Delhi‐ 110001 Datedi 7・」anuary.2016 To, M′s Lake Land Chemicals and a)Ltd 101,Vasan Udyog Bhavan, Opp Phoenix,High Street, S B Marg,Lower,Parel(W), Maharashtra‐ 40013 Sublect:App‖ caOon from M/s Lake Land Chemicals lndia Ltd forthe import of raⅢ matetta againstthe export of SORBITAN MON0 0LEATE (Advance Authorization No. 03'l 0791 049 dated 1 3. 1 1.201 4) I am directed to refer to your Advance Authorization application received from Otfice of DGFT on above mentioned subject. You are being advised to submit the following information within 15 days of the issue of this letter: 1 Detailed manufacturing process, material balance with balanced chemical reactions indicating stage-wise percentage yield along with the technical justification enclosing therewith authentic printed technical literature in support of yield or quantity of items for import. Details of production of SORBITAN MONO OLEATE and corresponding consumption of raw materials in the year 2013-14, 2014-15 and 2015-16 (April to September) duly certified by CA may be furnished. Any other relevant information Yours faithfully, (A K, AGAXWAL) 2 ＾６ Addl lndustnaI Adviser Tel No 011‐23381430 Ψ で1浩2誦器l:JAΥ:跳E昴亀雰lはな」:“ 戯留 Ce b DGFWUO No‐

It I A n'r-l{ . No.l50l L'll0/1015'PI (Non s) (lovernnrent of India Ministry of Chcmicals & Fertilizers Department of Phalmaceuticals ゞ,ハ_ノ 」 Udyog Bhawan,New Delhi. Datcd the I I'h September.2015 Office M entorartduq

Subject: - Iiixation of norms under para 4.7 of IIand Book of Procedures (Vol.l) 2009-14 Case ol

M/s Lncube lthicals Pvt Ltd. The undersigned is directed to reler to DCFT t,.O.No. 01/82/50/1480/AM- 1 5/DES-I/ I 271 dated the 04/01/15 vide which application ftom M,'s. Ercube Ethicals P.1 Ltd uas scnt to this l)cpartmcnt for fixati{rn ol norms under para: ,1.7 lbr the cxport ofClotrimazole l7o cream lOgm 'Iube. lhis Departnlcnt has cxamincd thc mattcr and thc ti)llo\'ing norms arc lumished under para 4.7 of Hand Book of Proccdurcs (Vol.l)l(x)t) l.l: liluconazolc caDsulc I50nr Imported input QLranlil) reconlnrended gn1/lUbe Clotrirnazole 10g [11 010 つ 1 35 030 100 100!,nr 20g m 020 4 270 50g nl 5gnr ign 005 1 675 067 03375 1 35 ()6(, 150 015 ( )cn lclodccanol Cetvl Palmitate ( ctostear\1 Alcohol 2 (,0 5 00 102 135 300 10(,0 009 030 030 050 1()() Irnrplr \lunriniunr ('ollapsiblc luhc 2(Hotrima201e l(′ )、aginal eream in 35gnl tubc ct、ld()dccanol ct、1 llelelanl. ura\ [t alloued as per packing ctostcalヽ1,ヽIcollol 4725 nlpt] AluDrinium Collapsible tubc Relevant. maY bc allowed as 1ll C10trima201C l`‰ crealn in 10gm.1 00gln,50gnl,5Em.3gm,and 10gm tube ak)nら lth logm with applicator (6 Nos per lube) pcr packing policl. 匡 Impon Itenr

Ii l ( lotrinrazok ]'7, r aginal crean in 2{lgnr tube Dircctoratc Cicncral ol'l.oreign I radc. Depafl ment of ( ontnrercc- (Shri M.V. Singh. lrl I)O). LIdlog Bhauan. Ne\ Dclhi fhtt^antt^ I Bamali Khasigir, I Inder Sccretary lo the Government of India Phone::1071162 S. No. Imp(nl llenr Qt). Rcconlmendcd gm/lube. | ( lolrinrilzolc (,408 ()cn ldodecanol ).70 ('c1\ll)irlnlilxtc 060 4 ( eloslcar\l Alcohol I'n1pl\ .\lunriniUfi (irllapsihle ruhc Relevant. nray bc allowed as per packinil policr. 6 l)lastic applicator 1i Nos pcr ruhe) lJ ( lotrinlnzolc l{)'2, \xginxl crexm in 5gm tubr S. No. Imporl Ilenl Qt]. Recommendcd gm/lube. | I l()lrinriiTolc 051 1)ct、1(llldccal〕ol 1)675 ('ct\ I I'irlrnitatr 0151, | ( ctostt.rrr l .\lcohol 030 ヽ l:npl\ AlurnilriLtnl ( ollapsthlc tuhc Rclc\ anl. mal.' be allowed as per packing policl. 6 l'lastic applicator tl \os pr'r ruhe)

‘ 」 “ ｎ， ′ ′ ‘ Ir. N0.350l l/32612015-Pl (Norms) Covernmenl oflndia Ministry ofChemical & Fenilizers Udyog Bhawan, New Delhi. the November.20l5 Office Memorandum

Subject: - Fixation ofnorms under para 4.7 ofHand Book of procedures (Vol.l) 2009-14 Case

of M/s Jubilant Cenerics Ltd. The undersigned is dirccred ro refer ro DCFT U.O.No. 0l/82l50/25lAM- l6lDES-3/84 dated the 16106/15 vide which application ti.om M/s. Jubilanl Cenerics t,ld was sent lo this Dcparlment for llxation ol norms under parat 4.7 for the export of Escitrlopram Oxrlat€ T{blets. This department has examined the mafter and lhe following norms are fumished under

para 4.7 of lland Book ofProcedures (Vol.l) 2009- t4:-

S. No. lnrpon Item Qry. Recommended. | Escitalopram Oxalate 6.515 mg/5 mg tablet Of I3.03 mg/i0 mg tablet OL 26.06 mg/20 mg tabler (Raj Kumar) Under Secretary to the Covernment oflndia Phone:23071 t62 Dircctorate Ceneral of Foreign 'frade, I)cpartmcnt of Commerce, (Shri M.V. Singh. F'TDO). t ldlog Bhauan. New Delhi クス/. ノフ●

3!, ilo /z) F No 350'11/503/2015-Pl (Norms) Government of lndia Shastri Bhawan, New Delhi, Dated December 28. 2015 Office l,4emorandum

Subject: - Fixation oI norms under para 4 7 o'f Hand Book of Procedures (Vol.l) 2009-

'14 Case of M/s Jubilant Generics Ltd. The undersigned is directed to refer lo DGFT U.O No.0'l/82l50/26lAM- 16/DES-3/559 dated the 10/07/15 vide which application from M/s Jubilant cenerics Ltd. was sent to this Depa(menl for the export of Atorvastatin 5 mg & l0 m9 tablets. This depa(ment has examined the matter and the following information is not available in the application and OGFT may call for the same from the applicant:-

Copy of valid Drug Manuacturing License issued by respective State Drug Controller
Copy of Master Batch Formula for export product.
Need for lactose is not reflected in the flow chart
Past consumption data for last 5 consecutive batches of both of the export products This rssues wrth the approval of competent autholty Under Secretary to the Governmenl of lndia Phone: 23071162 (Shri Ir,4 V Singh, FTDO), Udyog Bhawan New Delhi

I' \o.1501 1, ll5rl0li-l)l lNorns) (i()\crnment ol-lndia Minisrr) ol-Chemicals & Fenilizcrs Depannrent of Pharmaceulicals 9l/1 t39 t ldYo!r Bha!.rn-Ne! Delhi- I)rrcd the Jul).l()li Q|licg L1gtrqritld! !q .bjecl: - Fixation ol- norms under para .1.7 ol lland Book of Procednres (vol.l) 2009- 14 Casc o, ivl/s Nutra Specialities Pvt Ltd. .lhc undcrsigned is dirccted to reter to DCFT U.O.No. 0l /82/50/ I .16214 M- I5/DES- li 1352 dated the 09/01/15 vide !hich applicalion liom M/s. Nutra Specialities Pvt Ltd !as sent In this DcpannrcDl for firation of norms under para: 4.7 tbr the expo( of Olmesartan iuedoromil(APls/Brlk Drugs). This deparlmenl has examined the maner and il is requested rhat i)Clll nla) call complete technical details from rhe firm as per Appendix-iilor the export 0rodLjct Ollncsartan Mcdoxornil. {Barnali Khastgir) [ ]nder Secrelar\ Io lhe Covernmcnt of lndia Phonc:2i071 162 Dirccloratc Gcncral of Foreign Trade. l)cfn{m()nt ol'( ommerce. tShri I.1.V. Singh. F'IDO). I d\og Bllr\an- Ne\ Delhi ●

“ 一 ´ ρ ― ′ ′ ′ ‘ ^ F. No.350l l/567/2015-Pl (Norms) Government of India Ministry ol ('hcmical & Fenilizcrs [)cparlrncnl of Pharmaccuticals Udyog Bhawan, New Delhi, the January. 2016 l* bt-**,nt ( Officc Memorandum

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

2009-14 Case ol M/s Riddhi I'harma. The undersigned is directed to relbr to DGFT U.O.No.0l/82/050/691lAM- l6lDl-S-3/653 datcd thc 29107115 vide which application t'rom M/s. Riddhi Pharma. was sent to this Dcpanrnent fbr fixation of norms under para: 4.7 firr thc cxpofl of Dichloro propenol.'lhis dcparlment has examined thc matter and we may infbrrr DGFT that both export itern and import item I are same and the case in its prescnt tbrrn docs not havc any mcrit for consideration. Norms committee may take a view. 2. This issues with thc approval ofcompetent authority. [Jnder Sccretary to the Govcmrrent ol'lndia Phonc:2307 I l6l Directoratc General of Foreign Trade. Dl.partrnent of Commercc. (Shri M.V. Singh. F'TDO), (. t/o l3 6

)S )0, 1/ F No 14010′ 50′2010‐CH‐ 11 Government oflndia M n stry of Chem ca s and Fert‖ izers Departmentof Chem ca s and Petrochem ca s Sι ″。./り「 Shastri Bhavan,New Delh‐ 110001 Dated: 30いDecember.2015 To, M′s V D H Organcs Pvt Ltd D‐554,FlRST FLOOR,」K SCHOOL ROAD, BHA」ANPURA, DELHI‐110053, Sublect:― Advance AuthOnza10n App“ calon forthe import of raw‐ matenals against the export of Thymolc゛a:S(3 HydrOxIP‐ Cymene) (Advance AuthOrizaton No 0510392988 dated 27 1 2015 and 0510395874 dated 9102015) I am directed to refer to your Advance Authorizatjon applications received through Offlce of DGFT on the subject mentioned above and your reply dated nil in reference of this office letter of even number dated 14.8.2015 lot your eariier application. You have given the consumption details of different items without indicating the specific items. You are again being advised to submit the following information.

Detailed manufacluring process, material balance with balanced chemical reactions indicating stage-wise percentage yield along with the technical justilication enclosing therewith authentic printed technical literature in support of yield or quantity of items for import. 2 Specttc quantity of production of Thymol clγ stalS consumplon of META CRESOLS(M‐ CRESOL)in 16(Apl:tO septemberl du y certried by C A and coresponding the year 2014‐ 15 and 2015- lA K ACA品減Lik｀｀｀「 AddL Industrial Adviser Tel No 011‐23381430 shn Mahender V kram S ngh,FTDO(DES‐ 3),in reference to DGFT/UO No‐ 01′82′050/01266′ AM‐ 16/DES―‖′1222,dated 30 7 2015 and 15 12 2015

F No 1401α 75′201 3CH‐ ‖ Government ofindia Ministry of Chem cals and Fert‖izers Department of Chemicals and Pet「ochemicals 0私ルワ Shastri Bhavan,New Delhi l10001 Dated1 7th」anualγ ,216 To, M′s Shree Ganesh Remedies Pvl Ltd, Plot No 6011,NR,Aventis Pharma Ltd, GIDC Ankleshwar Dist BhanJch‐ 393002

Subject: - Advance Authorization Application for the import of raw-materials against the export

of Sorbyl Acetate. (Advance Authorization No. 3410040965 dated 16.02.2015) I am direc-ted to refer to your Advance Authorization application received through Office of DGFT on the subjecl mentioned above. ln this connection, you are requested to submit the following information within 15 days of the issue ofthis letter. 1. Detailed manufaciuring process, material balance with balanced chemical reactions indicating stage-wise percenlage yield along with the lechnical justification enclosing therewith authentic printed technical literature in support of yield or quantity of items for import. 2. Details of production of Sorbyl Acetale and conesponding consumption ot raw materials in the year 2013-14, 2014-15 and 201516 (April to September) duly certifled by CA may be turnished. 3. Any other relevant information. AddL industHal Adv ser Tel No 011‐23381430 Sh市 Mahender Vikram singh,FTDO_(DES-3),in reference to DGFTIUO No‐ 01′82′050/00696′ AM‐ 167DES‐‖ 1′1402. dated 30 12 2015 tElp,n-ll lA聰

tslB,,r-l[ F. No.3501 I /602/20 I 5-Pl (Norms) Covernment of India Udyog Bhawan, New Delhi. the Decemher 2015 Office Memorandum Subiect: - Fixation of norms under para 4.7 o[ Hand Book of Procedures (Vol.l) 2009- 14 Case olM/s Maharshi Pharma Chem Pvt Ltd. The undersigned is directed io refer to DGFT U.O.No. 0l/82/50/640lAM-l6IDES-3/7'16 dated the 10/08/15 vide which application from M/s. Maharshi Pharma Chem Pvt Ltd was sent to this Department for fixation of norms under para: 4.7 lbr the export of Triamcinolone Acetonide (BPruSP). I his department has examined the malter and the following norms are tirroished under para 4.7 of Hand Book ofProcedures (Vol.l) 2009-14:- 2. fhis issues with the approval ofcompetent authority. (Raj Kumar) Under Secretary to the Government of India Phone:23071162 Directomte General of Foreign Trade, Department of Commerce. (Shri M.V. Singh. FTDO). lJdyog Bhawan, New Delhi 3/L/J/釘 S. No. Expon Producl lmport Itern Q1y. Recommended kg/kg 1 Triamcinolone ( BPit rsP) (3-1R)r.4.e(l l).16- Prcgnatetraene-2 I -OL-l .2 0, Dione-2 I -Acelate L00 ). Triamcinolone Acctonide (BP/LJSP) ---Do--- 1.00

Udyog Bhawan,New Delhi, Datedthe September,2015 Office Memorandum

Subject: - F ixation of norms under para 4.7 of Hand Book of procedures (Vol.l) 2009- 14 Case

of M/s BDR Pharma lntemational pv1 Ltd. The undersigned is directed ro refer to DCFT U.O.No. 0l/82l50/t 179lAM-1s/DES_ 3/1241 dated the 03/03/15 vide which applicarion from M/s. BDR pharma Intemational pvt Ltd was sent to lhis Departmenl for fixation ofnorms under parat 4.7 fbr the export ofMeropenem l000mg end 500mg Powder for Solution for lrjection. This department has examined the matter and the following norms are fumished under para 4.7 of liand Book of proccdures (Vol.l) 2009-14:- ,5lhP-16 l. No.350l l/l l412015-PI (Norms) Governmcnt of lndia Ministry olChcmicals & Fenilizers Deparlment o f Pharmaceutica ls S. No. lmport Item Qty. Recommended. 1 Meropenem Trihydrate + Sodium Carbonate | 255.01mg/lgm vial And 627.505mg/500mg vial (Barnali Khastgir) Under Secretary to the Governmenl oflndia Phone:23071I62 Directomle (;eneral of Foreign Trade, Depanmcnt ofCommerce. (Shri M.V. Singh, FTDO).

^ lg lA/"'- l/ 弊 F No 35011/400′ 2015‐ PI(Norms) Government oflndia Ministry of Chemical&Fert‖ izers Shastri Bhawan, New Delhi, Dated: December 18 2015 Office l\4emorandum Sub; Fixation of norms under para 4.7 of Hand Book of Procedures (Vol l) 2OO9-14, Application of M/s Micro Labs Ltd The undersigned is directed to refer to DGFT U.O. No. 0'l /82150/006/4M 16i DES-3/491 dated the 08.07.2015 vide which an apptication from M/s Micro Labs Ltd was forwarded to this Department for fixation of norms for the Dicloxacilin 500 mg capsules. This department has examined the matter and it is observed that the unit of measurement for export product is indicated in KG and not in numbers. Furthermore the description of raw material to be impo(ed is Dicloxacilin BP/IP/EPIUSP, whereas as per DML each 500 mg capsule contains Dicloxacilin Sodium equivalent to 500 mg Dicloxacilin 2. Based on the DML the norm against this application works out to 533.88 mg Oicloxacilin Sodium per capsule of 500 mg. 3. However in view of the discrepencies noted above the DGFT may like to get the application revised so as to reflect the unit of measurement in terms of numbers and suitable description of raw mateial in line with the Drug manufactuing license. 4. This issues with the approval of competent authority P (Rat Kumar) Under Secretary to the Governmenl of lndia phone.. 2307 1 162 (Shri MVSingh,FTDO),

|ダ|"γ I". No.l50 I l/,s79120 I 5-PI (Nonns) Governmcnt ol India Ministry ol Chcnrical & l-crtilizcls [)epanment o I' Pharmaceuticals メメし′ ・ノ `ノ一 IJdyog I]hawan, New Dethi. thc ffi Ottce Mernorandum

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

2009-14 Case ol-M/s Alchemie Laboratorics. The undersigned is directed to refer to DGF'I' U.O.No.0l /82/050/0071 l/AM- l6/DES-3/838 dated thc 3ll08/15 vide which application frorn M/s. Alchcmie l-aboratories. was sent to this Department lor fixation of norms under para: 4.7 lor the export of ethyl benzyl aniline sulphonic acid. This department has examined the rnatter DGFT rnay ref'cr this casc to department of chemicals 2. This issues with the approval ol'competent authority. Under Secretaly to the Government ol lndia I)honc:23071 l6l Dircctolate Gencral ol'Forcign 'l rade. Depanment ofCommerce, (Shri M.V. Singh, III DO). Udyog Bhawan, Ncw Delhi

⌒ g/,lk, 167- 235 Ncw DdM,hc″ど肥‖瀧1営|: Under Secretary 10 the Government ol'lndia Phonc:2307 I 162 Direcbrate General of Foreign 'l-radc, Dcpaftment of Commcrcc. (Shri M.v. Singh, FTDO), Udyog Bhawan, New Dclhi rl' li. ,'.i-t, I r'-lo l{)1. l,l r,'r 11,1 ( lor cllrncnt o I' Inclia \liri5lr,, ( lrrr]rir.'l ,\ lL'rriliz..r. I)eparlrlerrl ol l)halltaceLrl ica ls 0tlice Men.ror.andum Subject: - liixation o1'nonns ,;d"[r.4i "f H-d Book of proccdures (Vol.l) 2009- 14 Casc ol'M/s Shilpa Medicare Ltd. The undersigneci is direcrcd ro re['er to DGFT U.O.No. 0l /ll2/50/(r I 7/AM_ l6lDL5-3/735 dated rhe 07l0u/15 vidc which application t-ron M/s. Shilpa Mcdicarc Ltd was scnt to this I)cpadmcnt lbr fixatiln ol'norrns under. para: 4.7 lbr the exporl of3a,7b Dioxy Cholanic Acid. This deparlment has exantired the matter and it is requcsted that Dclt'l may calJ complcte technical details ls pcr Appendix-33. l. l'his issues rvirh the approval ol'competenl authorily.

Elna4 F. No.l50l l/213/201 5-PI (Norms) Government oflndia Ministry ofChemicals & F ertil,zers ≦ 3ハらノランノ Udyog Bhawan.New Delhi, Dated the September, 2015 Office Memorandum Subjectr - l'ixation of norms under para 4.7 ofHand Book of Procedures (Vol.l) 2009-14 Case of M/s Nutra Specialities Pvt Ltd. The undersigned is directed to refer to DGFT U.O.No. 0l/82/50/1413/AM-1s/DES- 3/li6l dated the l0/01/15 vide which application from M/s. Nutra Specialities Pvt Ltd was sent to lhis Department for fixation of norms under pam: 4.7 for the export of Vild.gliptiD. 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. I m fx)rt Ilem 1 j-Aminoadamantan- l -ol ()682 つ (2S)- l -(Chloroacetyl)-2-Pyrmlidinie Carbonitrile 0634 llarnali Khastgir) tlnder Secretary to the Govcrnmenl oflndia Phone:23071162 Directorate Ceneral of Foreign Trade. Depaflment ofCommerce, (Shri M.V. Singh. FTDO), Udyog Bhawan. New Delhi .--..-.-...-

lダlρ 冽― lι F N0350H′ 566/2015‐ PI(NolH,s) Govcmmcllt ofindia ヽ4inistry OFChcmical&Fcrtilizcrs Dcparmcllt ofPharmaccuticals Ncw Dclhi thc Udyog Bhawan, December. 2015 otfice Memorandum

Subject: - F'ixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009- I4 Case

of M/s Unimax Labs P!,t Lld. The undersigned is directed to reLr to DGFT tl.O.No. 0l/82/50/778lAM- l6/DES-3/686 daled the 3l/07/15 vide which application from M/s. Unimax Labs Pvt Ltd was sent to lhis I)cpartmcnt tbr fixation of norms undcr pa'a 4-7 for the expon of Beclomethssonc Dipropionate and Mometasone Furoate. This depanment has examined lhe mafter and the li)llowing norms are furnished under para 4.7 ofHand Book ofProcedures (vol.l) 2fi)9-14:- I A lExport Producl Beclomelhasone DiDronionate S No lmport ltem 1 )-Bcta,I I-Beta-Epoxy- l 7-Alpha.2 I-Dihydroxy- I6- Beta-Methylenepregna- 1,4-Diene-3,20-Dione IDBH) 088 |〕Exoolt Produc(Momctasone ru“ "te S No Impon Itenr Qty. Recommended kgn(g. 1 16‐Alpha Methyl EpOxidc/9 11 Bcta‐ Epoxy_lフ、21- Dihydroxy‐ 16′ヽlpha―Methyl‐ 9 Bcta― Prcgnと1,4- Dicnc‐ 320-Dlonc |('() 'l his issues with the approval ofcompetenl authority. g渇ノ,■ , (RaJ Kumar) t,ndcr Sccrctan to thc Covcrnmcnt ofindia Phonc123071162 l)irectorate Ceneral of Foreign 1 rade, [)eparlmcnt of Commerce. (Shri M.V. Singh. FTDO). tld)-og Bhawan. New Delhi

ン | ^ , 11 Government ofindia Ministry of Chemicals and Fertlizers Department of Chemicais and Petrochemicals 9″・ /ケ ` Ref Subject: Advance AuthO「zation applcation from M′ s Eternis ttne chemicals Ltd for the import Of raw matenal against the export of ALPHA HEXYL CINNAMALDEHYDE/HEXYL CINNAMIC ALDEHYDE IAdvance AuthOrization No 0310295203 dated 5 5 2015) UO No 01′827050/01010′AM-16/DES-3′ 1101 dated 18 11 2015 l ltem of Export Qty Item of lmport Qty ALPHA HEXYL CINNAMALDEHYDE′ HEXYL CINNAMlC ALDEHYDE l kg 1 0CTANOL 0 803 KG 2 BENZALDEHYDE 0 614 KG This Esues with the approval of competent aulhority. M/s. Eternis fine chemicals Ltd. have submitted present application for the import of raw material against the export of ALPHA HEXYL CINNAMALDEHYDE/ HEXYL CINNAMIC ALDEHYDE The application has been examined and the Department recommends the following norms for the present Advance Authorization application lA K AGttWAL) AddL Industrial Adviser No 011‐23381430 ahe Sn of C&PC U O ESI Ud New D No 14010′ 57′2012-CH‐ ll dated ユ, 122015 一

t s le/^'-l/ F. No.350l l/58?/2015-Pl (Norms) Covernment oflndia Minisry of Chemical & Fenilizers Udyog Bhawan. New Delhi- the December- 2015 Office Memorandum Subiect: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s Arene Life Sciences Lld The undersigned is directed to refer to DCFT U.O.No. 0l/82150/655/AM- l6/DES-3/770 dated the 08/10/15 vide which application from M/s. Arene Life Sciences Ltd was sent to this Dcpartment for fixation of norms under para: 4.7 fot the export of Emtricitabine. This dcpartment has examined the mafter and it is requested that DGFT may call following technical details from the firm vizt (a) Norms applied under Appendix-4E does not match with the quantity imponed under Advance - Authorization. (b) Complete technical details as per Appendix-33 showing Mol.wt, oZ yield on molar basis and Recovery ofsolvents etc. 2. This issues with the approval ofcompetent aulhority. (Raj Kumar) []nder Secretary to the Government of lndia Phone:21071 162 I)irccloratc (;cneral ofForeign l rade. I)cpartmcnt of Clommerce, (Shri M.V. Singh. l l'DO). t ldyog Bhawan. Ne\ Delhi 3.lJ,')q)-

F No 35011′ 589/201S―Pl(Noms) Govcrnment ofindia Ministry oFChemical&Fcrlibzers Dcparlmcnl oI Pharmaccuticals UdYog Bhawan. New Delhi. the November. 201 5 Ofllce Memorandum

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

Lupin Ltd. The undersiSned is directed to refer to DGFT U.O.No.01/82/50/744lAM-l6DES-3/815 dated lhc 20/08/15 vide which applicalion from M/s. Lupin Ltd was sent to this Depanment for fixation of norms under para: 4.7 fbr the expon ofEthambutol Hcl. This depaamenl has examined the matter and lhe tbllowing norms are t-umished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:_ S No Qr). Recommended k8/k8. | 16014 0153 (〕1172 1 ()187 う Ethylene Dichloride (,4663 }ダlraメ sP^/・ノつ6 一 :. Bas€d on above proposed norms, it may also be recommend€d to revise SION A_225 for the Expon of Ethambulol Hcl and SION A-227 for the Export ofEthambutot Tablels 400 mg as under:- Norms proposcd for Rcv;sion of. S10N A‐ 22510r R(hambutol Hcl SiON A 22,for Ethambutol Tablets 400 叫 S No l Kg 1000ヽOS 1 1 6014 kg 06534k8 Tarlar c AcII 0153 00624 041,2 01702 4 0187 00763 5 Fthvlene Dic',lor de 04663 0 1903 (RaJ Kumar) Undcr Sccrcta,to thC COvernment oFindia Phonc:23071162 Dircctoratc Ccneral o「Foreign Trade Departmcnt oF Commercc, (Shn M V Singh FTDO) Udyo8 Bhawan New Delhi

八 r- l^ -. r./ l'lt't'-t' li. No.i50l l/64212015-Pl (Norms) (iovcrnmcnt of India Mir)istr\ ul ( lrcmical & lcnilizcr': I)cpaltrnent o t' Phannaceutica ls Ncw Ddh■hcノど藍鷲 ::闘ll Ol'llce Memorandum

Subject: - Fixation of norms under para 4.7 of I land Book of Pt'occdurcs (Vol.l )

2009- l4 Casc of M/s Brundavan Labs Pvt I-td. The undersigncd is directecl to reler to DGFT U.O.No. 0l /tt2/50(r54/AM- l6IDLS-3/800 datcd llrc l4108/15 vide which application fronr M/s. Brundavan Labs Pvt t-td was sct]t to this Dcpaftment lor fixation ofnorms undcr para:4.7 lirr the export of 3,5-Dibcnzyloxy Acetophenone. This department has exantined thc mattcr and the follorving norms are furnished under para 4.7 of Iland llook of Proccdures (Vol.l) 2009- l4:- Inrpoll ltcrl 51)ih、ld「o、、卜cnzoic Acid 0773 つ一 'l his issucs w ith thc approral ofcompctcnt authorit). Under Sccretary to thc Govcrnnlcnt ot lndirr t)honc:l.i07l l6l Directorate Ceneml ol Foreign Trade, Depat1men1 ol' Comuterce, (Shri M.V. Singh, li'l DO), [Jdyog t]hawan, Ncw Delhi ハ 9.N' /W

| F No35()11/547/2015‐ Pl(Norms) (;()vcmmcnt orindia Mhistr、 ()ドChcmical&Fcrllizcr、 Dcpart[1lcnl o「Pharlllaccuticals .l .l,,- Irl,,$ ,r ($ l).'llr rh( l'l)...ll \r "rl' ( )lil(r \4!-lI( trtlltdrlll l SLrlricclr - lri\irlion ol nornls undcr flril I7 ol llunLl ll{x}l ol'l)rcccdurcs (Vol.l) ]01)() Il ( r:c ()l Mrs llelero l-ehs l.td. 'l he undeNigned is direcled to rclcr lo l)(;lr 1 tl.O.No.0l,lltl/50/15/Alll-16,1)lrs-.lllll1, !lLrlc(l llre 17,/{)lJ,/15 rirlc shich rpplierli(nr liotr Nlls. ctclo [-abs I-td \0s s(nl lo ll]r
l)rl)i[trncnl lirl llration ol-nornl\ uIl(lcr paru: {.7 lirI thc c\port ot Bicxlut:rnlidc ll]i
t[perlnrent hrs exanrined thc nullcr il]r(l lhc lirllo!!irrg nornrs at'c tirnishcd unLlcr pllrrl J 7 ()l' lland llook ol I)roccdurcs (Vol.l) 100()-l-1:- gパ/2 lhis issucs r\ith 1he apprc\al ol eonrfclcrrt iruthorit). Undcr Secrctary to thc Ciovcnlnrcnl ol-lndia l'honc:l l07l I (rl Dircctorate (ieneral of Foreign Trade- Depa(nren1 olCommerce. (Shri M.V. Singh. FTDO). Odyog I)hawan. New Delhi rrir)o-l-l ritluoro Nlcrh] l-Ucrrzonitrilc 「 0533 030 1 04 ヽN。 Import ltclll Qt). Recomrlrcndcd kS'lg. つ一

r9f g,"t-lb (Raj Kumar) Under Secretary to the Government oflndia Phone:23071162 Ir. No.350l l/562/2015-PI (Norms) Governmen! of lndia Ministry ofChemical & [ertilizers I)epartment of Pharmace uticals Udyog Bhawan. New Delhi. the Decemb€r. 2015 Oflice Memorandum

Subject: - Fixation of norms under para 4-7 of Iland Book of Procedures (Vol.l) 2009-14 Case

of M/s Sandoz Pvt Ltd. The undersigned is directed to refer to DGFT U.O.No. 0l /82150/731 /AM-l61DES-31667 daled lhe 30/07115 vide ,hich application from M/s- Sandoz Pvt Ltd was sent to this Department tbr fixation of norms under para: 4.7 for the export of Clopidogrel Hydrochloride. This department has examined the matter and the following norms are furnished undcr para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S. No. lmport Itcm | L-(-) Camphor Sulphonic Acid 100 つ 4,5-6.7- l ctrahydrothieno (3.2.C) Pyridine HCI- iCyclic Amine HCL) 1.62 つ This issues with thc approval ol'competent aurhority. Direclorate Ceneral of Foreign Trade. Departmcnt of Commerce. (Shri M.V. SinBh- FTDO). lldyog Flhavran. Ne'w Delhi

n″ ″ ` ， ′ ′ ５ ^ ^ S筋 ″フ lr. No.i50l l/5li3/2015-Pl (Nornrs) Covcmment oflDdia Minislrt ol'( hemical & Fertilizers I)cpanll]cnt ol' Pharmaceulicals I J\ ()! Illrr\un. \r\ l'lhi. rhu |ftr..,rrt. ( ) ltcc Ntollql4rylltltl Subjcctr - |ixation ol no ns undcr pnrn-l 7 ol lland Ilook ol l)r.occdurcs (V()l.l) 100(),1.1 (ll\c ol \f,'s Kores Ilr(liir l-ld. lhcundcrsigrrcdistlilr'crcdrorutcltol)(iljlt;.O.\o.01 lil 50 (r-16.\t-l6l)LrS-l 7()(, Jutcd llrc I0108,15 \i(l( \lrich lprplielrioll lionr Nl,s. Korc: lndilr l_ld \1, sunr r() lhi
l)cllrrlrncll lirr fl\itlion ol'nLrrnts uni[r l)llrit: J.7 lor thc c\port ol 2 Mtthrl Benzhltlrrl ( hloridr. l his depilltntcr)t has extutinctl lhe ntatler at]d thc lirllouing no||ts ure lirrnishctl undcr l)ririr {.7 ol Hrnd l}txrk oi ProcctlLrlcq (Vol.l) 1009 l {r, l his issues with thc approval ol'competent authoril). Llndcr SccrclaD lo thc (;()rcr,tntcnl ol ludiu l)honc:l-'1071 I 6l Dil ccit)t t1lC(ICilcral ol「olじi8n lradc DcP〔Htn'Cnt()ドCon〕nlcrcc (Shii N4 V Sil18hドlI)()' t dy()81)l,aWa1l Ncw Dc hi itln]BOrtah、tl idじ hnpott ltenr Qt)'. Reconrnrcnded kg/lg. ヽヽぃＬ　一。． 0 102 1015 I |

|I.、, _1 Government ofind a Ministry of Chem ca s and Fert1 2ers Department of Chemica s and Petrochemicats 夕′ 卜、ス oジあサ Sublect Advance Authonza10n app“ calon from M′s Bhagiradha Chem ca s&industles Ltd for the import of raw mate百al against the expOrt of METHKOXY ACRYLATE 5 (METHYL(E)‐ 2‐ [2‐ (6‐CHLOROPYRIMIDIN-4-YLOXY)PHENYL]‐ 3-METHOXY ACRYLATE (Advance Autho「izaton No 0910062060 dated 22 5 2015) Ref: U O No 01783′ 50′656/AM‐ 16/DESl‖ ′748 dated 10 8 2015 M′s Bhag「adha Chemicals& Industnes Ltd have submitted present app‖ cat on forthe mpOrt ofraw material againstthe export of above export product The app‖ caton has been examined and the Departi¬ ent recommends the fo‖ owing norms forthe present Advance Author zation application This issues with the approval of competent authority. Addl lndustrial Advise「 Tel No 011‐23381430 噺面Mahender Ⅵkram Snoh FTDO(DESJ‖ )0′o DGFT Udvoo Bhawan New Ddh-11 1 1tem of ExpOrt Qty Lem oflmpo" Qty METHKOXY ACRYLATE 5 (METHYL(E)‐ 2‐〔 2‐ (6‐ CHLOROPYRIMIDIN4-YLOXY) PHENYLl‐ 3-METHOXY ACRYLATE) l k9

2- Hydroxyl PhenylAcetic Acid 107k9 2 Trimethvl orthoformate 0 950 kg 3 416 Dichloropyr midine 0 900 kg (A K AGARWAL) Deptt Of C&PC U O No 14010′ 17′2012-CH ldated t(122015 ハ

′ダ′a'“ F. No.350l I /653/2013-Pl (Norms) Govemment of India Depanment of Pharmaceuticals ゞ′イ´′ ・ア一 Udyog Bhawan, New Dclhi,the 22nd Januaり,2014 0fflcc Memorandum Sublect― Fixation or n。111lS under para 4 7 of Hand Book of Procedures(VoH) 2009-14 Case ofM/sIPCA Labs Ltd The undersigned is dirccted to refer to DGFT U O No 01/82/50/438/AM‐ 14 DES-3/595 dated the 07/10/13 vide which application iom M/s IPCA Labs Ltd 、vas sent to this Department for flxation of nolllls under para: 4 7 for the export of Metoproloi Succinate This department has examined the mattcr and the fo‖ owing nollils are nュmished undcr para 4 7 of Hand Book of Procedures (VoH)2009‐ 14■ ヽNo Impofi Item l ara Methoxy Ethyl Phenol 07955 つ Epichlorohydrine 06179 ■ 　一４ Succinlc Acld 04508 Mono Isopropyl Amine 06285 This issues with the approval ofDirector (Cost). (Raj Kumar) PI-Norms Directorate General of Foreign 1rade, I)epartment of Commerce, (Shri R.C. Meena, Dy. DGFT), LJdyog Bhawan, New Delhi. 一一

6lDilt 1". No.350l I /630/201 5-l'l (Noms) Government of lndia Ministry of Chcmical & l-enilizers Dcpartrnent of Pharmaccuticals Udl og llhau an. New I)elhi. thc l++rrlr. l0 l(r at'ht,L h\ ht( Olllcc 'lcmoranrlunr

Subject: - Fixation ol-nolnrs undcr para .1.7 ol'Iland Book ol'ProceclLrlcs iVol.ll

1009-14 Casc ol M/s IIetro Labs Ltd. lhe undersigned is clilcctecl 1o rcllr to D(ilil U.O.No.0li ltli 050,1X)0ll .\l- l6'Dl:S--l''El0 dittcd thc l0i0iirl5 ridc \hich application lirrrrr NIis. llclro l-iibs Ltd. \as scnt to this [)cpa(nrcnt lirl lixation ol nonns urdel para: -i.7 lirl thc export ol l,amivudinc. Ihis dcpartrncnl hus cxarrincd the r'r'rlllcr and it is rrotcd that expon itenr is lanrivLrcline and irrrpolt iteur is again laurirLrcline in its chenrical namc ancl applicd sastage is I I.(r9u. In riew ol abovc and sincc inrporl and ex1'ror1 itenrs ar.' sanrc chcnrical corlpouncl. this applicltion lrrlry not hilve any rncril lol colrsiclclllion. Norrns cornnrittcc r'na\ tlrkc r linal decision. l. 'lhis issues rvith thc approval ol competcnt authority. IJnder Secrctary to thc (iovcmnrent ol lDdia Phonc:2-]071 l6l Dircctorate General oI Foleigil Ftadc, Dcpalllllcnt oF Conlinncrcc (Shri｀И V Singh,「 II)())、 Udyog Bhawan,Ncw l)clhi rハ/。ジらタ一 l,「71・ '' (R■i Kunlar)

Office Memorandum Subiect: - f ixation of norms under para 4.7 of Hand Book of Procedures (Vol l) 2009- 14 Case of M/s MorePen l,abs Ltd The undersigned is directed to refer to DGFT U O No 0l/82/50/618/AM- 'j 6/DES-3/788 dated the l0/o8/livide which application from M/s Morepen Labs Ltd was sent lo this l)enarlmentlbrfixationofnormsunderpara:4'Tforlhee\ponofsilagliptinPhosphrte Monohydrate. Thi\ depanment haq e\amined the mafler and the follo\ring norms are furnishcd under para 4.7 ofHand Book ofProcedures (Vol-l) 2009-14:- rS /Ar)-X F. No.350l l/598/201 s-PI (Norms) Govemment oflndia 9/J6.3-t Nc、v Dclhi thc Udyog Bhawan, December.20l5 (Rai Kumar) Phone:23071162 2. 'l his issues with the approval ofcompetent authority' Directorale Ceneral of Foreign lrade' (Shri M.V. Singh, FTDO). Udlog Bhawan, New Delhi HGE tAmtnol Oxo4-(2,4,5-Trifl uoroPhenyl) l-5.6,7.8-Tctrahydro-3-(Tritluoromethyl)- 1.2,4- iaz-olo[4.3-Alpha] Pyrazine Mandelate Salt vlenc Chloridc lsopropylAlcohol Qty. Recommended kg&g. lmport kem 1 283 3.84 2R8 ドＬ

,∫|や― )ι F. No.350l l/57712015-PI (Norms) Covernment of lndia Minislry ofChemical & Fertilizers 3.y', 2c/ office Memorandum Subicct: - Fixation ofnorms under para 4.7 olHand Book of Procedures (Vol.l) 2009-14 Case of M/s F'ermenta Biolech l-td. The undersigned is directed to refer to DCFT U.O No. 0l182/50/775lAM- 16/DES-3/836 dated the 3l/08/15 vide which application from M/s. Fermenta Biotech t-td was sent to this Depaflment for llxation of norms under para: 4.7 for lhe export of 4cholecrlciferol (Vit'min D3) RPruSP,/EP. This departmenl has examined the matter and the following norms are lurnished under para 4.7 of Hand Book of Proccdurcs (Vol.l) 2009- I4:- 2. This issucs uith the approval ofcompetent authority. Dircctomte General of Foreign Trade, Department of Commerce. (Shri M.V. Singh. FTDO). Udyog Bhawan. New Delhi New Delhi. the Udyog Bhawan. December. 2015 (Rai Kumar) Under Secretary to the Covernment oflndia Phone:23071 162 S. No. lmporl Item Qty. Recommendcd ke/kg- 1 Cholcsterol .1.I4 うヽ4cthvlドormatc , Pet(olcum Ether (.25 4 246-Colidinc 0362

Fノ″― /6 L No..l50l l 6lb'1015-l)l (Norms) Covcrnmcnt ol' lndia Ministrl ol'( lrernical & lrertilizers l)epanrlcnt ol Phannaccuticals Udyog Bhawan, New Delhi. the w OlIcc Memorandum Subjcct: - Fixation ol'nonns undcr pam 4.7 of Hand Book ol Procedurcs (Vol.l) 2009-14 Case ol'M/s Clobe'frotters Pvt. Ltd. '['hc undersigncd is directed to rct'er ro DGFT U.O.No.0 l/82/050/00781/AM- l6lDIrS-3/805 dated the 20/08/15 vide which application liom M/s Globe Trotters Pvt. Ltd. was sent to this Depanmcnt lbr fixation of norms under para: 4.7 lbr thc expon of Ampicillin Sodiurn BP(Stcrile). This department has examined thc natter Expofl product is Arnpicillin Sodiurr BP(Sterile) and no chemical dctails are available in the application. DCF1 is advised to call complete technical details from thc lirm as per appcndix-33. ^ %ヘイ 6'マ0ア L (Raj Kumar) 2. This issues with the approval ol'cornpetent authorily. Directoratc General ol'Forcign Trade, (Shri M.V. Singh, I l'DO), tJdyog Bhawan, New I)clhi lJndcr Scclctary to thc (;overnmcnl ol lndia I']honc:1.107 I l6l

sla*tt F. No.l50l l/558/2015-PI (Norms) Covernment oflndia Department of Phatmaceuticals Ofl'ice Memorandum Subjecl: - Fixation oI norms under para 4.7 of Hand Book of Procedures (Vol-l) 2009-14 Case of M/s IPCA Labs Ltd. The undersigned is directed to refer to DGIT tJ.O.No. 0 l/82/50/771lAM- l6/DES-3/710 daled the 0,1/08/15 vide which application from M/s. IPCA Labs Ltd wlls sent to this Depintment for llxation of norms und er para: 4.7 foi the cxpo( of Triamcinolone Ac€tonide' Ihis dcpartment has examined the matter and the following norms are fumished under para 4'7 of Hand Book ofProcedures (Vol.l) 2009-l4:- l. This issucs with the approval ofcompetent authority. Department of Commerce. (Shri M.V. Singh, FTDo), IJdyog Bhawan, New Delhi Nc、v「)clhi thc Lidyog Bha$an. I)ecembcr. 2015 (Raj Kumar) tJnder Secretary to the Government oflndia Phone:2307, 162 I /16. ZA S No. lmport Item Qty. Rccommended kg/kg. | l20 Oioxopregna- 1,4.9( I l),16 Tetraen-2I -Ylacetate (3- t'R) 1 00

ハ i5lA,-l( F. No 35011/500/2015-Pl (Norms) Government of lndia lvlinistry of Chemical & Fertilizers P.'tt, 2rl Shastri Bhawan, New Delhi, Dated. December 23 2015 Offrce lvlemorandum

Subject: - Frxation of norms under paz 4.7 oI Hand Book of Procedures (Vol.l) 2009 14

Case of M/s Theon Pharma Ltd The undersiqned is directed to refer to DGFT U.O. No 01/82i50i789/AIVl-16/DES- 3/645 dated the 29107115 vide which application from M/s Theon Pharma Ltd was sent to this Department for fixation of norms under para 4 7 for the export of Cefuroxime 750 mg injection. 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.- lmport ltem Qty. recommended Cefuroxime Sodium Sterile USP 814.243 mglvial 2 This issues with the approval of competent authority Under Secretary to the Government of lndia Phone: 2307'1162 Drrectorate General of Forergn Trade, (Shri M V Singh, FTDO), Udyog Bhawan. New Delhi

tslon-td F. No.350l l/601/2015-PI (Norms) Government oflndia Ministry ofChemical & Ferrilizers Departmcnt of Pharmaceuticals New Delhi. the Office Memorandum Udyog Bhawan. I)ecemher. 2{)15

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

of M/s Dhanuka Labs Ltd. l'hc undersiSned is directed to ret'er to DCFT U.O.No. 0l/82/50/6l9lAM-16/DES-31115 dated the 10/08/15 vide which applicaiion liom M/s. Dhanuka Labs Ltd was sent to this Department tbr fixation ofnorms under para: 4.7 lbr the export ofCefdinir USP/BP,{P[P/EP Powder. This dcpa(ment has examined the matter and the lollowing norms are furnished under

para 4.7 of Hand Flook of Procedures (Vol.l) 2009- l4:-

l his issues with the approval ofcompetenl authority. (Raj Kumar) Under Secretary to the Covemment oflndia Phone:23071 162 l)irectorate Ceneral oi Foreign Trade, Departmenl of Commerce. (Shri M.V. Singh. l;l'l)O). tld)og Bhawan. Ncw I)clhi 0 ^^ Pt3 S- No. Import Itcm Qty. Recommended kg,/kg. 1 7AVCA 0.80 , Vethylene Chloride 6.21 Ictra I lydr()luran 2.17 4 \4ethanol t.85 5. CAし,И 1 397 6. Iriethylamine 0155 '7. Methane Sulphonic Acid 0.96 8 Activaled Carbon 0 100 ｌｒｌト

も)酔…|` | r′ た /.´ ιダ 22, F No 35011/623/2015P(Norms) 60vernment oflnd a Ministry OF Chemicals&Fert‖ izers Department of Pharmaceut cals Udyog Bhauran, New Delhi, Dated the l6.J]3l+.r0+€- offi.e Memorandum Atb'' 'tr

Subject:- Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009 14 Case of M/5

EYTAN LABS LTD. The undersiSned is dire.led to refer to DGFT U.O. No.01/821050/00661/AM 16lDES )/B0B dated the 20/08/2015 vide wh ch appl cation from M/s EYTAN LABS LTD. was sent to th s Deparrmenl for fixation of norms under para: 4.7 for the export of 4 AMINO 5 FLUORO 1 (2R HYDROXYM ETHYL I1,3].OXATHIOLANE 55 YL) 1H PYRIM]DINE 2 ONE EMTRICITAE]NE(EMS II), This department hd5 examined the rnatter and the fol owing norrns are furnished under para 4 7 of Hand Book of Procedurct (Vol 1) 2009 14: S No lmport ltcm Qty. Recommended for 1 kB Export 1 Glyoxyllc Acid 50% 160K8 2 2,5 Dihydroxy 1,4 Dithiane 073K8 1 13Kg 3 5 F uoro cytos ne 4 Hexamethyl Disilazane 1 64Kg 5 DimethylFormarnide 0フ0 6 TriethylAmine 2 23Kg 7 N-hexane 5 038Kg 8 Methylene Chloride 11908K8 126K8 046K只ハ 9 Cyclo Hexane 10 Sodium Borohvd「lde Dipotassium Hydrogenphosphate 1 90Kg R3ス■品 (R3J咄品li) Under Secretarv to the Government of lndia Phone: 23071162 D recto「ate Ceneral of Foreign Trade, Department of Commerce′ (Shn M V Sngh′ FTDO)′ udy08 Bhawan,New De hi LI

I l5 /A''r'ru F. No.350l I /353/20 | 5-PI (Norms) Government oflndia Udyog Bhawan, New Delhi, the November. 2015 Office Memorandum Subjecl: - l ixation of norms under para 4.7 of Hand Book of procedures (Vol.l) 2009-14 Case ol M/s Indoco Remedies Ltd. The undersigned is directed to refer ro DGF'| U.O.No. 0l/82/50/203/4M- I 6/DE5-3/243 dated the 30/06/15 vide which application from M/s. Indoco Remedies Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Latanoprost Ophthalmic Solution. ]'his department has examined the matter and the following norms are furnished under para 4.7 ofHand Book ofProcedures (Vol.l) 2009-l4t (Raj Kumar) Under Secrelary lo the Government oflndia Phone:23071162 Directomte Ceneral of Foreign Trade, Department of Commerce. (Shri M.V. Singh, FTDO), 5,s", 929- SI No Export Commodity descriDtion Inputs description Norms Recommended | Latanoprost Ophthalmic Solution. 0.005%0 or I25 micrograms per 2.5 ml l. Latanoprost 0.l3l2ms/2.5m1 vial 2. I]ye drop bottle (Packins material ) l.0l numbers for each vial 3. Eye drop caps (packing material ) l.0l numbers for each vial 4. Eye drop insen (Dackinq material) l.0l numbers for each vial

,. t n n-ll l>/ 11 F. No.350 I l/571l20 I 5-Pl (Norms) Governmenl oflndia New Delhi, the Office Memomndum Subiect: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s Optimus Drug Pvt Ltd. The undersigned is direcled ro refer to DGFT U.O.No. 0 t/E2/50/6?2/AM- 16/DES-3/695 dated the 3l/07l15 vide which application from M/s. Optimus Drug plt Ltd was sent to this Dcpartment for fixation ofnorms under para: 4.7 for the export ofsofosbuvir. This departmenl has examined the matter and it is requested that DCFT may call following technical details from the firm viz:- (a) Complete technical details including chemical reaction. molar requirement with justification and % yield on molar basis for backward integration of propan lntermediate. (b) Copy oftechnical literaturc in support ofyield invisaged in backward reaction from basic stage. 2. This issues with the approval ofcompetent authority. (Raj Kumar) Phone:23071 162 Directomte General of Foreign Trade, (Shri M.V. Singh, FTDO). t ld1-og Bhawan. New Delhi 9,/J.. 297 Udyog Bhawan. Decembcr. 2015

り=い ‐μ F. No.350l I /561/20 I 5-PI (Norms) Govemment of India New Delhi, the Udyog Bhawan. December. 201 5 Ollice Memorandum

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

2009- l4 Case of M/s Unimark Rernedies Ltd. The undersigned is directed ro refer to DGFT U.O.No. 0l/82/50/728lAM- l6IDES-3/666 dated the 30/07/15 vide which application from M/s. Unimark Remedies Ltd was sent to this Department for fixation of norms under para: 4.7 lbr the export of Montelukast Sodium. This department has examined the matter and it is requested that DGFT may call following technical details from the firm viz'.- (a) Complete technical details as per Appendix-33. (b)Past production vis-ir-vis Actual consumption ol all imported inputs duly certified by Central Excise Authorities. 2. This issues with the approval ofcompetent authority. (Raj KumaD Under Secretary to the Govemment of India Phone:23071162 Departmenl of Commerce, (Shri M.V. Singh, F'I'DO), !/, /J, 929

μ 」 ″ ― ― ‥ ， ′ ５ F. No.350l l/560/2015-PI (Norms) Govemment of India Ministry olChemical & Fertilizers Udyog Bhawan, New Delhi, the December, 2015 Office Memorandum

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

2009- l4 Case of M/s Unimark Reredies Ltd. 'I'he undersigned is directed to refer to DGFT U.O.No. 01 /82/50/j26/AM- 16/DES-3/664 dated the 30/07115 vide which application from M/s. Unimark Remedies Ltd was sent to this Department lor fixation of norms under para: 4.7 lbr the export of Lisinopril Dihydrate. This depafiment has examined the matter and it is requested that DGFT may call following technical details from the firm vtz:- (a) Complete technical details as per Appendix-33. (b)Past production vis-d-vis Actual consumption of all imported inputs duly certified by Central Excise Authorities. f. This issues with the approval ofcompetent authority_ (Raj Kumar) Phone:23071 162 (Shri M.V. Singh, FTDO), 9N"'22(

slhn-tt F. No.350 I | /555/20 I 5-Pl (l.lorms) Covernmenl oflndia Ministry ofChemical & Ferrilizers Udyog Bhawan. New Delhi. the December. 2015 Office Memorandum subiecl: - Fix ion ofno..r rnd", pui?iifEliiTlil of procedures (vot.t) 2009-t4 Case of M/s Shreegen Pharma Ltd. 'l he undersigned is directed to refer to DGFT U.O.No. 0l/82150/690/4M_ l6/DES_3/648 dated the 29/07/15 vide which application from M/s. Shreegen pharma Ltd was sent to this Department for fixation ofnorms under para: 4.7 for the expon of Rosuv.statin Cllcium. This deparlment has examined the matter and the following norms are furnished under para 4.7 of IIand Book of Procedures (Vol.l) 2009-14:- S No Impon llcrn Qty. Recommended kg/k8. | (4R-Cis)6-[(Acetyloxy!Methyt]-2.2-Dimethyl- t,3- Dioxane-4-Aceric Acid- l,l-Dioxane-4-Acetic Acid-1. | -Dimethylerhyl Ester L80 つ 4-(4-Fluorophenyl)-6-l sopropyl-2-[(N-Methyl-N- Methylsulphonyl)AminolPyrimid jne-5-yl-Merhanol t.80 2 'fhis issues with thc approval ofcompetent authority. (Raj Kumar) Under Secretary to the Governmenl oflndia Phone:23071 I62 Director,itc General of Foreign Trade. Department of Commerce. (Shri M.V. Singh, F'l DO). Udyog Bhawan. New Delhi el,*tc, 229 -'-

ハ t.IF,-'-l/ l,l lr. \o.1501 1,607/201 5-l'l (Nornrs) ( i()\cnnnenl ot lndiir Mirtislr\ ol Chemical & l:crtilircrs I)cpLrlrDcnl of Phal]1lilccuticitls ^ Cl /A. 236 [ ](l\ (r,t Bhr\liln. N($ l)(llr. rhc i[q l)(icr;hur. ](lli Bhartrn. Ollice Memorandunr

Subject: - Fixation ofnornrs under para 4.? ofHand Book of Procedutes (Vol l) 2009-l'l Case

of M/s Granules lndia Ltd. Tlre undersigned is directed ro ret'er to DGFT tJ.O.No. 0I /82/50/665/AM - l 6/l)ES-i/846 dated tlre 3l/08/15 ride rvhich applictrtiorr f'ronr M/s. Cranules lndia Ltd was scnl to this Depanment tbr fixalion of norms undcr para: 4.7 lbr the export of Atrzlnavir Sulfxte lhis depanment has examincd the matter and the following norms are fumished uDder para 4'7 ol- Hand Book ofProcedures (Vol.l) 2009-14:- lmlro( llcnr ()lv Reconrmendc(l lu/k!. cfl-llut) l-l-(-1-(l)) ridiD-l-\ l) llcnT)l ll、dr(1/]lC(arbo、ヽ lを:tc 05(, 2R.3S)-l-(Tert-Bulo\y Carhon) l) ino-1.2 Epo]-.1-Phenyl llutanc 0..1e lorotnclhane -+.,t I Melhoxycarbon) I l-rl ct1-l.cucinc N‐ l)ic、cl()hc、、Icarboιlli〕li(1ぜ llris issucs with thc approval ol colnpetellt authority. 0.17 0.79 5.51 (ll.iri Kunrir) []ndcr Sccrclar] to thc Co\ c lnlcnl ol- ln(liil 1)1,()],ヾ:23()711で、2 Directolale (icneral of Foreign l ritdc. Departnrelrt ol Commcrcc. (Shri M.V. Sin8h. FTDO). [,]d)og Ilhirwan. New I)clhi ２一 ■ 一４一，一 ‘ 「一

， ′ ０一 “ ハ１ｊ ′ ′ Ｓ F. No.l50l l/550/2015-Pl (Norms) Govemment of lndia Ministry ofChemical & Fenilizers Department of Pharmaceulicals Nc、v Delhi the Udyog Bhawan. December. 2015 Office Memorandum

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

of M/s Granules India Ltd. The undersigned is directed to rcfer lo DCFT tl.O.No. 0 | /82/50/666/AM- I 6/DE5-3/79 t daled the l4l08/15 vide which application from M/s. Cranules lndia Ltd was sent to this Deparlment for fixation of norms under para 4-7 fot the export of (2R-Cis)-2- Hydroxymethyl-s(s Fluoreytosine-lyl)-(lJ) Ox.tiolsne EMS-II. This department has examined the matter and the tbllowing norms are lurnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009- I 4:- S. No. lmport ltem l Glyoxalic Acid 50% 1.60 , 2.5-Dihydro-1,4-Dithaine 0.7.i 5-Fluoroc、losinc t.l3 | He\ameth! I t) i\ilalanc (l IMDS) 1.6,{ ヽ Sodium Borohydride 0..t6 6 ヽ4cthvlcnc(1l oridc 11 908 I his issues rvith the approval ofcompetent authority. 3/, ハる2アチ (Raj Kumar) Under Secretary to the Covemment oflndia Phone:23071 162 , l)irectorate General of !oreign Trade. l)eparlment of Commerce, (Shri M.V. Singh. FTDO). l.ld_v-og Bhawan. New Delhi

ハ F. No..i50 I I /(r I 2/20 I 5-PI (Norms) Governmcnt of lndia Ministry ol' Chcmical & Fertilizcrs Deparlment of Pharmaceuticals Ncw De lhi, thc lf ψハイο ・2ク。 Udyog []hawatr. I)ecenrbcr. 201 5 ( )llicc l4-qllarllr dln Subicct: - l:ixatiotr rrl ttortlts tttltlet pitra 4.7 ol llancl llook ol l)rocctltttcs {'ol.l) 1009- l.l Casc ol'\1is Viial l)crlutncs l)\ t l'td' lhc undersignccl is ilitcctcrl lo teler to IXi[ | ( l O No 0lll]l/50r76-l'r\Nl l6il)l:S-l(r9li claic,l rhe -ll,r07 I5 ritlc shich apPlication liorn \l s \ ilrrr I'cllirnrcs l)rt l.td \rts scnt to this l)cPaflnlcnt liu llxlliotr ol lrorl']ls trtldcr l)iirir: -1.7 lirr the c\pol't (r1 -Nlcthrl Bcnzothiazenc MethYl Estcr' This (icpllrtnlclll has crrmincclihe lllitltcr and ir is recltrcsted thar tXili l ntal crtll I'ltst proclrtclit'tr vis-l-r'is Acltttl conslrmption ol'ltll irnportctl irlputs lirrnr thc lilrtl tltrll ccrtilictl h\ ( ( trJl I rcisc .\rrtlr,,r'itic: n l. .l his issucs rr illr lhe llPProi,irl ol cot'npclctrt aLrlhority' y {,*x (ll.ri K u rn.U ) Ilnclct sccretarl to thc (iovcrllllrcrll ol lrl(lirr [)h()rr.:] 11)7I I ('l I)ilcctoratc (icncral ol l:olcigtr Ilitilc. [)cprl tnlenl ol C'otntttttcc. (Shri ir,l.V. Singh. l:l l)o). [ ')c11og Bhauan. Ncu l)clhi

ハ l,い・―た F No 14010/85/2010‐ CH― ‖ Govemme■t oflndia Ministry of Chemicals and Fert‖izers Department of Chemica s and Petrochemicals ダハる・21? 一 To, M′s Tide lndustnes BlodくNo 231. Pratappura,Halol, Gularat‐ 389350 suue“ ‐ 01::1誓端:1子::■柵‖譜馴 :∝ he而pOn d r～mamJsaganst he “ 鷺』TW‖習 l」錮風誕u開[l』%綿il鴇悧i:‖R]ilifl乳y」Ъ鼎 : issue of this ietter Shastr Bhavan,New Delhi l10001 Dated 21't DeCember,2015 Addl lndustna Adviser TeL No 011-23381430 | 2 Any other relevant inforrnation, f any 4 マ惧ヽ「 Shri. Mahender Vikram Singh , FTDO (DES-3), in reference to DGFT/UO No.- O I l82t O5O lO1 047 I AM-'1 6/DES-ll U1'1 73' dated 8.12.2015 Yours fanhfu‖ y, (A.K, AGARIIVAL)

ヽ

)51ら “ ― lも F. No.350l l/5652015-PI (Norms) Govemment of lndia Udyog Bhawan, New Delhi, the December, 2015 Office Memorandum

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

2009-14 Case ofM/s Sun Pharma Industries Ltd. The undersigned is directed ro refer to DGFT U.O.No. 011821501795/ANt- 16/DES-3/727 dated the 04/08/15 vide which application from M./s. Sun Pharma lndustries Ltd was sent to this Department for fixation of norms under para: 4.7 fbr the export of Orlistat. This department has examined the matter and the Ibllowing norms are furnished under para 4.7 ofHand Book of Procedures (Vol.l) 2009-14- S No Import ltem Qty. Recommended kglkg. l (S)― (― )-2,2-Bis(diphenylphosphino)-1,1- binaphthyl 0003 つ 2 methoxy propene 3246 3 Acetone つ一８，ｐ 4 Activated Carbon 0100 5 Dicvclohexvl carhodiimide 1003 6 Diisobutyl Aluminium Hydride 6606 7 Dirnethvl Formarnide 0057 8 9 Forrnic Acid 052 L-Leucine 046 10 Lithium Hexarnethyldisilazidc in TIIF(UndiStilled) 1971 ll Methvlene Chloride 1223 つ ´ Mcldrulll Acid 2095 ヽＤ Methanol 1945 14 N-l Icxane 415 sA/.′ Ч`_

くＪ -C)ctanoyl Benzotriazole 2809 16 Palladium sponge 00004 ７ ′ Pivaloyl Chloride 0841 18 Pvridine ＯＯｒＤ０ 19 Dichloro-(p-cymene)-ruthenium (ll)-dimer 0001 つ一 Tetrah y drofureLn ,1.53 ， ¨ Tolucne 1278 つ一３ ´ l riethl larrine 0774 2. This issues with the approval ofcomPetent authority. (Raj Kumar) Under Secretary to the Govemment of India Phote:23071162 (Shri M.V. Singh, FTDO),

sl4n't"t F No350H/553/2015‐ PI(No,口ts) Govcrnmcnt oFindia Ministry of Chemical&Fcrtilizcrs Departmenl ofPhat`"accuticals New Delhi. the Otfice Memorandum tJdyOg Bha、van, Dcccmbcr 2015 Subjcct: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s Saurav Chemicals Ltd. The undersigned is directed to refer to f)CFT U.O.No. 0l /t2l50/788/AM- 16/DES-3/645 dated rhe 29107115 vide which application from M/s. Saurav Chemicals Ltd was sent to this Depanment for tlxation of norms under paftt 4.7 for the expon of Loroprofen Sodium Hydrrte. This department has examined the matter and the following norms are furnished undcr para 4.7 ofHand Book ofProcedures (Vol.l) 2009-14:- S No Imporl ltem Ql). I{ccommendcd k8/kg. | 2-(4 Bromomethyl) Phenyl Propionic Acid 06024 つ Melh) l-2-Oxoct-clopcntanc Carbox) late 096 2. This issues with the approval ofcompetent authorit)'. (Raj Kumar) Under Secretary to the Govemmenl oflndia Phone:23071 162 Directomte General of foreign Trade. Depanment ofCommerce. (Shri M.v. Singh. FTDO). Udyog Bharvan. Ncw Delhi ゞ^4 29 一

― ｌｌｌ ′ て ′ 作 “ ―め Udyog Bhawan, New Delhi, the December. 2015 OtIce Memorandum Subiecl: - Fixalion ofnorms under para 4.7 oj'Hand Book ofprocedures (Vol.l) 2009-14 Case of M/s Eytan Labs Lrd. Thc undersigned is direcred lo rel'er to DGFT U.O.No. 0ll82l5 0/650IAM_t6/Dt 5_3/77,] datcd thc 10/08/15 vide which application from N,r/s. Eytan Labs Lrd was sent to lhis I)epartment tbr fixadon of norms under para: 4.7 for the export of 4_Amino_2_Oxo I'yrimidinyl Oxathiolane-2-Caboxytic Acid Isopropyt Methyt Cyclo Hexyl Esrer (Cycto Hexyl f,ster ) Or (CHE) Or (CHEJII). Ihis depanmenr has examined thi matter and the lblk)win8 norms are fumished under para 4.7 oflland Book ofprocedures (Vol.l) 2009_14:- F. No.l50l l/599/2015-Pl (Norms) Govemment oflndia Ministry of Chemical & Fenilizers ′ ″′。´ ノ望 (Raj Kumar) Under Secretary to the Covemment oflndia Phone:2307 I 162 う This issues with the approval ofcompetenl authority. I)ircc()rale Ceneral of Foreign Trade, Department of ('ommerce. (shri M.V. Singh, FTDO). lldyog Bhawan, New Delhi S No Impon ltcm Ｌ一２一 ■ 一４ GlyOxylic Acid 50% 2 5 Dihydroxy l,4-Dithianc l'\tosine 0746 0327 0434 I lcxamethyl Disilazane 0709 か I)imclhyl formamide 026 6 Ir;elhyl Amine 067 ７一＆一９ Methylcne Chloride N-Hexane 1 56 263 Cvc!o Hcxanc 079

tEl6r^-lL F. No.350l | /568/201 5-Pl (Norms) Covemment of India O . Ministry otChemical & Fenilizers s /./t' 9 ( 1 Udyog Bhawan, New Delhi. the December.20l5 Office Memorandum Subiect: - lixation ofnorms under para 4.7 ofHand Book of procedures (Vol.l) 2009-14 Case of M/s'Irimax Biosciences Plt Ltd. The undersigned is direcred to refer to DCFT U.O.No. 0 | /82150/669/4M- I 6/DES_3/655 daled the 29107/15 vide which application liom M/s. Trimax Biosciences pvt Ltd was sent to lhis Department for fixation ofnorms under para: 4.7 for the export ofN-(2-Oxo_1,2_Dihydro- Pyrimidin-+yl)-Bezamide. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book ofProcedures (Vol.l) 2009-14:- , 'fhis issues with the approval ofcompetent authority. (Raj Kumar) Under Secretary 1o the Covemment of India Phone:23071 I62 Directorate Ceneral of Foreign Trade, Deparlment of Commerce, (Shri M.V. Singh. FTDO), S. No. Import ltem Qty. Recommended kg^g. | 4-Amino- I H-Pyrimidin-2-One (Cylosine) 0.7) つ一 l') ridinc 0627 Benzoyl Chloride 0.91

⌒ |_~ノハ。・― F No 35011/596/2015‐ PI(Norms) 6overnment of ndia Ministry of Chemicals & Fertilizers Department of Pharmaceutacals 夕′ ^/・ ‐ 2そ一 Udyog Bhawan, New Delhi, Office Memorandum Dtted“e l畔批 "″ Sublect:― Fixation of norms under para 4 7 of Hand BOok of Procedures(VoLl)2009‐ 14 Case of M/s MVLAN tABORATORIES LIMITED The undersigned is directed to rerertO D6FT U O No 01/82ノ 050/00653/AM‐ 16/DES‐ 3/760 dated the 10/08/2015 vide wh ch applcat on from M/s MYLAN LABORATORIES uMITED wassentto th` Department forfixation of oorms under para1 4 7 forthe export ofしOPINAVIR This department has examined the matteiand the folowing norms are Furnished under para 4 7 of Hand Book of Procedures (Vo1 1)2009‐ 14 Under Secretary to the 6overnment of tndia Phone:- 23071162 D rectorate Ceneral of Foreign T「ade′ Department Or commerce, (Shn M V Singh′ FTDO), Udvo8 8havvan,Ne、v Delhi S No lmport ltem Qty. Re.ommended for 1 kr Exoort 1 しPhe ne 0フ10k負 2 2'イ1 3 butanoic acid {TPA) 0656 3 N N CI(bonyl d“ m dazo e(CDI) 0 53kR 4 2,6 Dimethyl phenol 0618k8 5 Potassium carbonate 1 368kR 6 … 9hydride 0 819kg 7 (L) Pyroglutamic acid 0316k2 8 Triethanolamine 1 00kg 9 Citric acid monohydrale 4 1lkg 10 Melhane sulfonic acid 1 867kg n heptane 0 336kg ＾２ Acetonitrile 064k8 ヽ３ Tetrahydrofuran 1 24kg 14 D llethyl acetamide 0657k8 15 1,2-Dimethoxyethane 5 58kg 16 Methyl tert'butyl ether 7 13kg 1フ Dimethyl forma mide 1 075kg 18 Toluene 1 45kg 19 Methvlene dichloride 0865k8 20 lsopropylalcohol 0463k8 21 Methanol 534フk: /9 (R百〃「

. ". ,J, ,2,,) r, - F. No.350l l/556/2015-Pl (Norms) Government oflndia Ministry ofChemical & FertilizErs Ncw Dclhi,thc Udyog Bhawan, December- 2015 Office Memorandum

subject: - F'ixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case

of M/s West Bengal Chemical Industries Ltd. 'l he undersigned is directed to refer to DGFT U.O.No. 0l/82150/683lAM-l61DES-3/641 dated the 29107/15 vide which application from M/s. Wesl Bengal Chemical Industries Ltd was :rcnt to this Dcpartmcnt for fixation of norms under para: 4.7 for the cxport of L-Methylfolate Calcium Bio-Activ€ form of Folic Acid- This department has examined the matter and it is requested that DGFT may call complete technical details from the firm as per Appendix-33. 2. This issues with the approval ofcompeteot aulhority. (Raj Kumar) Phone:23071162 Directomte General of Foreign Tmde, (Shri M.V. Sinsh. FTDO), 3. /,/a- )4(

⌒ $)0""''tt F. No.350'l 1/498/201 5-pt (Norms) Government of lndia 夕′～′° 2イ′ Shastri Bhawan, New Delhi, Dated: December 23. 20.15 Offic€ Memorandum

Subject: - Fixation of norms under pa? 4 7 of Hand Book of procedures (Vol.l) 2OO9_14

Case of M/s Softgel Heatthcare pvt Ltd ^.-- Ih" undersigned is directed to refer to DGFT U.O. No. O1/82/50/631/AM_16/DES 3/652 dated the 29107r1s vide which apprication from r',ry" soij"i il"iit "rr" pvt. Ltd. was sent to this Department for fixation of norms under para. +."7 lor if,e export of Ente c :-g.1"1 Fl:h Oit 50O mg capsutes. This departmeni n"" ",,"rinJin" matter and the rorowrng norms are turnished under para 4 7 ol Hand Book of procedures (Vol.l) 20Og-14:- 2 This issues with the approval of competent authoraty. t) (k,, Under Secretary to the Governmenl of lndia phoner 2307.1.162 3廓:躍it讐辮謂 [晋。 n TttdQ (Shn M V Singh FTDO) UdyOg Bhawan,New Delhi lmport ltem Qty recommended Fish Lipid Oil EPA 33o/o & DHA 22ya 0.51 gm per 500 mg capsule

⌒ $l},:.lL F. No.-.i5i) I I /6:i3/20 I 5-PI (Norms) CoT,cmnrent of India Minislry ol Chemical & Ferrilircrs Departmerrt ol' Phanrraceuticals ^ Ollicr Mcotornndunl Subi.flr -lri\alionol nor'rrs rrnder la|l-1.7 ol lland Book ol-l)roceclru.es (V()l l)ll)0() l-l(.rsr ol l\lts I-ce l)hrrInt l-ltl. .l lre undersigned is direcled ro ret'er ro l)GF'l- U.O.No. 0l/82/50/6.19/AM- l6/l)F.s-l/817 dated thc 20/08/15 r'itlc uhich application l'rom M/s. Lcc Pharma l-ld \as scnr 1() lhis Depa(ment fbr flxation ol-norms under para: 4.7 tbr the export ol Prcgabalin. Ihisdcpanntenr has exanlined the matler iu)d the tbllowilg rronrs are f'unrished under para 4.7 ol'l land llook of l'}roccdures (Vol.l) 2009- I :l:- lnlport Ilenl Rccol,,ぃlclitlCtl kt k望 3-(2-Amino-l-O)io Ethl1),5-Mcthylhcxanoic id sopropt Alcolrol 1.5.1 ′″oつい Llnder Secrctaly to the Ciovcmnlcnl of lndia l'honc:ll07l I6l Ncw Ddtt ncダ撒綜温躙: , I his issues \ ith llrc appro\ al ol conlpetenl aulhoril. Dircctoratc Gcneral of I-olcign l rade. Departnrent of Comrnercc. (Shri M.V. Singh. Fll)o). Udyog Bhawan. Neu l)clhi ヽヽぃ ― 　　つ一

To, Shastri Bhavan,New Delhi‐ 110001 Dated: 15h December,2015 PAB ORGANICS PVT LTD, 904‐905 ATLANT:SHEIGHTS DR VIKRAM PVT LTD, SARABHAI MARG,VVADi VVADL VADODARA‐ 3923 Advance Authorization App cation forthe import of raw materia:s againstthe export of +だ,-3(CarbamOyl Methyl)‐5-Methylhexanoic Ac d (Advance Autho「ization no 3410041360 dated 7 7 2015) Yours faithfully, (A K AGARWAL) F No 14010/84′ 201,CH■ 1 Government oflndia Ministry of Chemicals and Fen"izers Department of Chemica s and Petrochemica s C″`2,た Addl lndustr al Adviser Tel No 011-23381430 Sublecl: I am directed to refer to your Advance Authorization application received through Office of DGFT on the subject mentioned above. ln this connection, you are requested to submit the following information within 15 days of the issue of this letter. I' Detailed manufacturing process, material balance with balanced chemical reactions indicating stage-wise percentage yield along with the technical justiflcation enclosing therewith authentic printed technical literature in support of yield or quantity of items for import ,, Details of produclion of +/-,-3-(Carbamoyl Methyl)-5-Methylhexanoic Acid.and corresponding consumption of raw materials in the year, 2014-'15 and 2015-16 (April to November) duly certified by cA may be lurnished. 3, Any other relevant information ミスヽぐ閂 :鵬滉Ⅲ肥ζ冊」剛躙辮∝わDGFT/∞“―

ヘ

Gc ,emment of lndia M inistry of C,tEmicab and FertilizeE Department of CiEmicab and Petrochemicab s.. /a' 28o 鋤ЧeCl Mぬα "Autho「 ●lon appica“on from M/s Su面01d Chem由b Ltd for the import ofraw mate市Jヽp nst the expoはof Thec Tお12掏μ」roXy Ethゾ)に∝rnurate lAdva曖 Authorレation No 0310790820 dated 7 11 2014) UON● 01′ 83′ 50′ 838′AM 15′圏 V7103 dated 5 5 2015 Refl M′s Sunshe d chemicaS Ltd have submttted present applicalon for the import of raw matenal 中inStthe expon of TheびTrS(2‖ydroxy Ethメ)swanumte ■ "applicalon has been examined and the Department r― mr en“ the fo‖ owing noms for the p―ntAdvattAutho「●ation applicat on Thb issu€s with the approval of competent authority. lAκ mん鳴 Add lndぃtnd Adv“ r Tel No 011‐23381430 Item of lmport 4 1tem ofExpon T「EOR町2調ydroxy Ethソ ) ISOunurate Deptt OfCttaCUO No 14010′ 107/2010C「 ‖dated 27 102015

Government of lndia Ministry of Chemicals and Fertilizers Department of Chemicals and Petrochemicals 3. y'.' 28) Subject: M/s. Dorf- Ketal Chemicals lndia Pvt. Ltd. have submitted present applications for the import of raw material against the export of Chemical-Polymer Additives The application has been examined and the Department recommends the following norms for the present Advance Authorization applications. This issues with the approval of competent authority. Advance Autho日zation applcation from M′ s Dorf― Ketal Chemicals lndia Pvl Ltd forthe import of raw materal againstthe export of Polymer Addl,ves― N,N, Dialkyamino‐ Diphen methane― UOP No 225′un‖ ink 4200′ CN‐2357′Stock‐2357) etc 体腑ヽイ AddL lndustnal Adv Ser Tel No 011-23381430 nce Authorizaton No 0310797252 dated 15 7 2015 イ ltem of ExpOrt Qty Item of lmport Qty Po ymer Addnives_N,N, Dia kyam no‐ Dipheny methane‐ UOP No 225′unl nk 4200 ′CN― 2357′ Stock‐2357) l kg

4,4- Methylenedianilane /MDA 0 6450 kq 2 Methyl Ethyl KetOne 0 7200 kq 33%P aunum catalyst(2020 Ca「bon su nded′cP RW S DOPED 43515) 000013 kg Autho「zation No 03 10797178 dated 13 7 20
ltem of Export Qty Item of lmport Oty Organ c MIXture,SR 3414 R l kg
Glyoxylic Acid 50% 0 713 kg r Vi D0 FT U Deptt of C&PCUO No 14010t176t2011-CH]l dated 15 12.2015

^ Government of lndia Ministry of Chemicals and Fertilizers Department of Chemicals and Petrochemicals S杉 ′′フ SubjectAdvance Authorization application Irom M/s. Alkyl Amines Chemicals Ltd' for the import of raw material against the export of Acetonitrile Ref: DGFT U.O. No. O'I/82IO5O/975/AM16/DES-llU1146 dated 26'l'1 2015 (Advance Authorization No 310797246 dt. 15.7.2015) M/s. Alkyl Amines Chemicals Ltd. have submitted present applications for the import of raw material against the export of Acetonitrile The application have been examined based on the addition information furnish by the nrm. ftre be'partment recommends the following norms lor the present Advance Authorization application. l tem of Export Qtv Item of lmport Qtv AcetonttH e l kg l Acelc Acd 1 766 kg This issues with the approval of competent authority. Addl lndust「ial Adviser Tel No 044-23381430 (A K ACARWAL) m Si Deptt Of C&PC U 0 No 14010′ 85′ 2012‐CH l Bh dated 8 122015

Subject: of raw Ref: Goveinment ofindia Dep酬‖ :7』硼珊留ξ謂層1:i諦ictts £ん′。'28g Advance Authonza10n applcauon from M′ s AVA Chem calS Ltd fortheimport mate門alagainstthe export of EDTA Fernc Ammon um L qu d UO No 01′827050′ 1407′AM-15′DES ‖′1168 dated 26 2 2015 (A.K, AG)ARWAL) Addl lndustrial Adviser Tel No 011‐ 23381430 M/s. AVA Chemicals Ltd. have submitted present application for the import of raw material against the export of EDTA Ferric Ammonium Liquid The application has been examined and the Department recommends the following norms for the present Advance Authorization application' ι(ち´ ‖em oflmpon l lEthylene Diamine Tetra AcetiC Acid)(EDTA) EOTA Fenic Ammonium This issues with the approval of competent authority' Deptt. oI C&PC 14010′ 67′ 2011‐CH II 2262015

Govemment oflndia Dep酬1諸∬辮留ζ謂濯翻鳳icJs 9,'.L. 289 (A K ACARWAL) Addl lndustr al Adviser Tel No 011‐ 23381430 M/s. Dorf- Ketal Chemicals lndia Pvt' Ltd' have submitted present applications for the import oi raw material against the export of ChemicalPolymer Additives TheaoDlicationhasbeenexaminedandtheDepartmentrecommendsthefollowing norms for the p;esent Advance Authorization applications' Subject: This issues with the approval of competent authority' 出品出 il略騰」 1継ぷよ馳β鴇『1獅∬lT41側暇船::秘W, etc (ヽア No 031 )797252 dated 15 7 201

Item of Export Qty Item of Import Qty l kg 1 4,4‐ Methylenedianttne′MDA 0 6450 kq |。lyme「 Addn ves_N,N. Dialkyamino― 別ⅧTh%`yOl淋 2357′ StOCk‐2357) 2 MethvI Ethyl Ketone 0 7200 kg T a%Eatlntrrn Catalyst- ( 2020 carbon Sulfided /CP RW S DOPED 43515) o00043 ko AlllhoH2a10n No 0310797178 dated 13 7 2唖
ltem of Export Qty l kg Item of lmport Qty l GlyoxブC Acid 50% 0 713k9 Organic MiXture,SR 3114 R k「a h DG Deptt of C&PC U 0 No 14010′ 176′2041-CH ll dated 45 42 2015

ハぢ1沿“ ‐ lι F No 35011/637/2015‐ Pl(Norms) 6overnment oflndia IUinistry of Chemicals & Fertilizers ′ 勁´2し Udyog Bhawan, New Delhi, Dated the Office Memorandum

Subject:- Fixation of norms under para 4.7 of Hand Book ot procedures (Vol.1) 2OO9-14 Case of M/s

Aurobindo Pharma Ltd. The undersigned is directed to refer to DGFT u.o. No. olaz/oso/7golAM-15/DES 3/1023 dated the 28/10/2015 vide which application from M/s Aurobindo pharma ttd. was sent to this Depa(ment for firation of norms under parar 4.7 for the export of Lopinavir. 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:- Under Secretary to the Government of lndia Phone 23071162 (Shri M.V. Sinth, FTDO), Udyo8 Bhawan, New Delha S No 1 Methanesulfonic Acid lmpo.t ltem Qty Recommended ror l kg ExpOrt 1 867kR M ne Glycol Dimelhyl Et ,И o ) 669k8 ヽ３ Trifluoroacetic Acid 1816k■ 4 L‐ Phenvl Alanine 0 709kR 5 L Valne 0761k8 6 Sodium Eorohydride L Pyro8lutamic Acid N-N'Carbonyl Di lmadazole 0 819kg 0316k8 0606k8 8 9 10 Activated Carbon (Carbon Enoanticromos) Acetonitrile 0100k8 0 195kg 11 D methy'ormam de(DMF) 2496k8 12 lsopropylAlcohol 6603k8 13 14 15 Methanol Methylene Chloride Tetrahydrofuran 13184k8 5230k8 6 909kg 16 17 N Heptane Steam/ThermalCoal 4 326kg As perfueI Polcv 匡

151今rヽ―|る廿 9,;ro,.dr291, 3rl UdyoB BhnwJn, l,lew Oelhr, Date.l the qa Jar)Uary, 20tf, F No 35011/54/2015‐ Pl{Norf)ls) Gove ll〕le1lt oFlndia 1 l stry(,F Chcnlic.nls&Fert‖ 12ers Del,arttぅle tofP,narllacet ticals The ndersiSned ir dire,l.(l to refer lo DGfI U.O. No. 0.1/8210S0/01057/AM-16/tiES 3/1r62 dated the LIS/12l2015 vklr, tvlrii lr .pplicarron h (,rr M/s CtPtA LTD. was senr ro rhis OeDirtr)renr I(,, fixatior of nornrs under pari: 4 / L)r the exDorl .,fTELMISARTAN AND AMLODtNptNE TABLITS 40/10MG. Thil departntent hai exanrined tlte rrlatter and the following nornts are fuflrished urxter para 4 7 of,land U.ok of pro.edrrra.. {V.r 1)200rr 14.- Olir.LU!enrorandUnr

Subject: Fr\dtion of rollrrs !frl{,r 1,.| a 4 T of ti.r rd Book of Pro.edures (Vo . t) 20()9 t4CJ:.eDf N,t/J

C PLA LTO. I Qty Recommendedf3「lNo■百面ξ ― r Tein,isartan and Al1l ot iう in 31avere( 40/10〕13 「

― I0 70mB TelmisartaD and Anrlodipin Bilayered Tab. 10 70nlg 80/10ing Telrnisartan and Amlodrpln Biiayered Tab 5.15mg 4. I Telnrisartan and Amlo,lpin Bilayere.l iab. 5 35nls 80/5nrB lRtt Kuma→ Under SecretaⅣ to the Governn]ent oFlndia pho le: 230フ1162 Darertorate General of Forei8n Tr ade, Depariment of Conrmerce, (Shri M.v. SinBh, FTOO), | 1 呵ＬＩＩＩトーーー」 141 456ing 70728n18

Udyog Bhawan, New Dethi, Dated: '11 january, 2016 Office Memorandum Sub: Fixation of norms under pata 4.7 ol Hand Book of procedures (Vol.l) 2009-14, Application of M/s Cipla Ltd. The undersigned is directed to refer to DGFT U.O. No. 01/82150/1061/AM16/DES-3/1 161 dated rhe O8/1212015 vide which an apptication lrom Nr/s Cipla Ltd. was forwarded to this Department for fixation of norms for the export of Amoxicillin and clavulanate poiassium. This department has examined the matter and the following norms are recommended against this application:- F. No.350'1 1/435/2015-Pl (Norms) Government of lndia lmport item t5fsfl.l( S, ^/o.2Sl f椒脚i sN可 Amoxic‖ ‖n tlhydrate Clavulanate pot ヽ´υth s‖ icon dioxide li4 Sl con dioxide(sy10id 244FP) lmport item icillin trihydrate Clavulanate pOt ヽ ´υth s‖icon dioxide l:1 S‖ con dioxide(sy10id 244FP) 11lpaCkngmateJall For export of amoxiciliin and clavulanate potassium for oral suspensron USP For export of amoxicillin and clavulanate potassium for oral suspension USP 75ml pack size '10846 71mg 18077.85m9 1608.107m9 2680 178mg 2500 0mg 4000 0mg ant, as per packing policy Under Secretary to the Government of lndia Phone: 23071162 s雨6「 | 1 2 3 4 to 200ml pack StZe 28924 56nng 4288 284mg This issues with the approvat of Director (pharma lndustry). Department ol Commerce. (Shri MVSingh,FTDO), Udyog Bhawan, New Delhi. 1500 0mg Relevl 75mipack SIZe 4519 40mg 2344 40mg １　（Ｚ　　３ 3125 854mg 4688 781mg '1500 Omg 2OO0 omg 3000 0rrg Relevant,as per packing po‖ cソ

)51ヽ 7・AヽX F No 35011′ 618′2015‐ Pl(Norms) Government oflndia Ministry of Chemical&Fert‖ izers Departmenl of Pharmaceuticals sP/スノι´′ 9乞 Udyog Bhawan, New Delhi, Dated; 04 january, 2016 Office lvlemorandum Sub: Fixation of norms under pata 4.7 of Hand Book of Procedures (Vol.l) 2009-14, Application of M/s Cipla Ltd. The undersigned is directed to refer to DGFT U.O. No. 01182150110621AM16/DES-3/1 '189 dated the 09/1212015 vide which an apptication from NI/s Cipla Ltd. was forwarded to this Department for fixation of norms for the export of Aerodini 100m9 inhale(2ooMD) etc. (19 export items). This department has examined the matter and the following norms are recommended against this application: (1)Exoort item: Aerodini 100mcg inhaler (200MD)/salbutamol pressurized inhaler BP 100mcg (200NID) with 58 mcl aerosol valve and 1gmt aluminium can. lmport item lmport recommended for 1 No. lnhaler Sa lbutamol o.o! sm 58 mcl Aerosol Valve 19mlA umin um Can 1 01 No 1 04 No 4 01 No 0.48mm OD Actuators with dust cover/ca 1, 1 ,'1 ,2-Tetrafluoroethane (HFA 134A 18.2 gm Prope antD (2) Export item: Asthalin HFA 100mcg inhaler (200MD) Salbutamot lOomcg inhaler (200[/]D) with 50mcl aerosol valve and '19m1 aluminium can. import item lmpo( recommended No. lnhaler 0029m 1 01 No 1 01 No 0 48mm OD Actuators wnh dustc… 1 01 No 1.4,1,2-Tetraf uoroethane(HFA 134A 14.40 gm (3) Exoort item: Beclomthasone dipropionate 50mcg inhaler (2OOMD) with 63mct aerosol valve and 'lgml aluminium can. fo「 1 Salbutamol 50 mcl Aerosol Valve :鱚 | | ^ ―¬ 19ml A umin um for 4 1

2 3 4 ttl0/n-16 スく2 つづ ` 63 mcl Aerosol valve 1 04 No 「「召司 19 ml aluminium can O.48mm OD Actuator with dust cover/cap 1 ,1 ,1 ,2-Tetrafluoroethane (HFA '134A P「。pe antl Ethanol (4)Export nem:Bec10methasone d prop Onate 100mcg inha e「(200MD)wnh 63mc aerosol valve and 19ml alumintum can tmport iiem lmport recommended No lnhaler 1 01 No 1 01 No 17749m _ 0 02gm 1 01 No 再¬ Beclomethasone dipropionate 63 mcl Aerosol valve 19 ml aluminium can 0.48mm OD Actuator with dust cover/cap 1,1,1,2-Tetrafluoroethane (HFA'1 34A PrOpe antl Ethanol 1 01 No 1 01 No 17 288gm 09129m (5) Exoort item: Beclomethasone dipropionate 200mcg inhaler (200MD) with 63mcl aerosol valve and 1gml aluminium can. lmport item Beclomethasone dipropionate 63 mcl Aerosol valve 19 ml aluminium can 柩四 1 01 No 1 01 No 1 01 No 16 37gm 1 824gm l 0059m 1 01 No 1 01 No 1 01 No 0 48mm OD Actuator with dust cover 1,'1,1,2-Tetrafluoroethane (HFA'1 34A Propellant) Ethanol (6) Export item: Beclomethasone dipropionate 250mcg inhaler (200MD) with 63mcl lmport item lmport recommended No lnhaler Beclomethasone dipropionate 63 mcl Aerosol valve '19 ml aluminium can 0.48mm OD Actuator with dust cover 1,1,1.2-Tetraf uoroethane(HFA 134A 15.909m Prope‖ ant) _ aerosol valve and 1gml aluminium can. Ethanol 2.289m 」八 04569T S No １２３４５　６ ■ 一２．３一４５コ /

!rlor-16 ハ(7)Export nem:BudesOnide nhale「200m∞(200MD)wnh 19mt aluminium can 2q_ 58 mcl aerosol valve and 004 lmport recommended for 1 No. lnhaler 18.2 gm ちイ6 | | | S No lmport item Budesonide 58 mcl Aerosol Valve 19ml Aluminium Can 0 48mm OD Actualors with dLrst coverlcaps 1、1.1,3-Tetraf uoroet hane(HFA 134A Propellant) 1 1 01 No 1 01 No 1 01 No (8)Expon nemi Budesonide nha er100mcO(2oOMD)wth 58mc aeroso va ve and 19ml aluminium can. lmport item lmport recommended for 1 No lnhaler 0029m 1 01 No 1 01 No 1 01 No 18.2 gm (9) Export item; Salmeterol rnhaler 2smcg (120MD) with 63mcl aerosol valve and 14nrl aluminium can (10) Export item: Fluticort plus-25mcg l-1FA inhaler (120MD) / Salmeterol 2smcg fluticasone prop,onate 125nrcA inhaler i120N,4D) with 63mcl aerosol valve & 14ml 58 mcl Aerosol Valve 19mlA um num Can o.aamm ODActuators with dust cover/caps aluminium can. lmport recommended No. lnhaler S No lmport item lmport recommended for 1 No. lnhaler １２ Salmeterol 63 mclAerosol Valve __ 00039甲 1 01 No 3 14ml Alum nium Can No 01 4 4 0.48mm OD Actuators with dust cover/caps 1 01 No 12 5gm 5 1,1,1,2-Tetrafluoroethane (HFA 134A Propellant) 6 Ethanol 0.2569m Salmeterol lmport itenr 0 003 gm ト J S No I Budeson de

Fluticasone propionate 63 mclAerosol Valve rslern-tu 鍋2 0 015gm 1 01 No 1 01 No 1 01 No ´ザ` ――― ] コ 0 48mm OD Actuators w"LJust,OVer′Capp l,1,1,2-Tet「aruo「。ethane(HFA 134A 12.5 gm (11)ExpOn lemi Fulcon p us 250mcg HFA nhale「 (120MD)sa meterO125mcg and f ut casone propionate 250mcg inhaler(120MD)with 63mcg aerosOlvalve and 14nnl aluminium can lmport item lmport recommended fOf Salmeterol No. lnhaler Fluticasone propionale 63 mclAerosol Valve 14mlA um nium Can 0 48mm OD Actuators with dust 1 ,1 ,1 ,2-Tetrafluoroethane (HFA lmport item Salmeterol Fluticasone propionate 63 mcl Aerosol Valve lmport recommended No. lnhaler 0塑gm O■3gm 「　一　一ヨ「 1 01 No 1 01 No cover/ca 1 01 No 12.5 gm 0.2569m (12) Export item: Fluticort plus-somcg HFA inhaler (12OMD)/ Salmeterol 2Smcg and fluticasone propionate 50mcg inhaler (12OMD) with 63mcl aerosol valve and 14ml aluminium can. S No fo「11 0匹 Ogm 9理Ogm lg No 1 01 No 0 48mm OD Actuators with dust cover/caps 1 '1 1 .2-Tetrafluoroethane (HFA 134A Prope‖ an■ ___ Ethanol (13) Export item: Beclomethasone dipropionate somcg and salbutamol 100mcg inhaler (200MD) with 50mcl aerosol valve and 19ml aluminium can l4mlAluminium Can lmport item Beclomethasone dipropionate Solbutamol 1 01 No 12 5gm 0 256gm lmport recommended for 1 No lnhaler O Olgm ヨ 4 2 3 50 mclAerosol valve 00291m 1 01 No Propella Ethanol 19 ml aluminium can 1 01 No う／一　＾く）　 ′ ↓ 　ムＪ　会 υ 　　　　， ′ 一（　　 ● ■ 一２一３一４一５一。　一７ S No

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gけ ` Propellant) Ethanol (14) Exoort item: Fluticasone propionate 5omcg inhaler (120MD) with 63mct aerosol valve and '14m1 aluminium can. lmport recommended for '1 No. lnhaler Fluticasone propionate 0 006gm 1 01 No 1 01 No 63 mclAe「osol Valve 14mlA umin um Can O48mm OD Actuators with dust covery'cir 4 01 No 1,1,1.2-TetranuorOethane(HFA 134A 12.5 gm Propellant 0.2569m (15) Export item: Fluticasone propionate .l25mcg inhaler (120MD) with 63mclAerosot valve and 14ml aluminium can. lmport item lmport recommended for '1 No. lnhaler 63 mcl Aerosol Valve 'l4mlAluminium Can 主QJ09m ,48mm OD Actuators wnh dust cover′ ca l‐ 1.1.2 TetranuttOethane(HFA 134A ー (16) Export item: Fluticasone propionate 2SOmcg inhaler (120MD) with 63mcl aerosol valve and 14ml aluminium can. lmportitem 1 01 No 1 01 No 1 01 No 12 5 gm lmport reaommended for 1 No. lnhaler 壁堕璽里堅n奎一、 l4mlAluminium Can 0.48mm OD Actuators with dust 1 ,1 ,1 ,2-Tetrafluoroethane (HFA Propellant) Etha nol 0039m 1 01 No 1 01 No 1 01 No 12 5gm 0 2569m cove″caps 434A (17)Export nem:Formotero fuma「ate nhaler and 10ml aluminium can S｀。| ~~ lmpO[lem llむ。セJ mmarate 12mcg(120MD)wnh 40mcl aerosOl va ve 21し 1 01 No 14 04gm IS No l S No l ~~~ 引轡留Tdげ ] 暴ビ１一２一３一４・５ 5lqn-lL 0.369m | lmport item 1 2 3 4 5 ∃ ∃ 1 6

` ,
● 10mlA um nium Can 0 48mm OD Actuators wtth dust cover′ ca 19mlA um nium Can 0.48mm OD Actuators wrth dust cover/ca 1,4,1,2-Tetrattuo「oethane(HFA 434A .slAn)i 21‐ 1 04 No Budeson de inha e「20076mcg(120MD)wnh can lmporl recommended Ior 1 No. lnhaler 000072 0.024sm 移びι 40 mcl Aerosol Valve 1 01 No 4 01 No 1 , 1 ,1 ,2-Tetrafluoroethane (HFA 134A 7.849m Propellant 0169m (18) Export item: Formoterol fumarate and Budesonide inhaler 100/6mcg (120MD) with 58mcl aerosol valve and '19m1 alumtnium can. lmport item lmport recomminded folt No lnhaler FormoterolJumarate olqqz2sm Budesonide 58 mclAerosol Valve frOpttlant)__________ (19) Export item: Formoterol fumarate and 58 mcl ae,osol valve and lgml alumin um lmpoft item Formoterol fumarale Budesonide 58 mcl Aerosol Valve 19mlA uminium can 0 48mm OD Actuators with dust cover/ca 1 ,1 ,1 ,2-Tetrafluoroethane (HFA 134A This issues with the approval of Director (Pharma lndustry) 12.2 gm (Rttkumar) Under Secretary to the Covernment ofindia Phone:23074462 1 01 No 1 01 No 1 01 No 2 Directorate General of Foreign Trade,l Depa(ment of Commerce (Shri MVSingh, FTDO), Udyog Bhawan, New Delhi. 0 042qm 1 01 No 4 01 No 1 01 No 12.2 gm | S No 3 4 5 S No 1 Propellant)

′ , ,

^ s)w-rt F No.35011/618/2015-Pl (Norms) Government of lndia 9,r1"-t1
Udyog Bhawan, New Delhi, Oated: 04 january, 20'16 Office L4emorandum Subr Fixation of norms under para 47 of Hand Book of Procedures (Vol.l) 2009-14, Application of M/s Cipla Ltd. The undersigned is directed to refer to DGFT U O No O 1/82150/1 096/4N.416/D ES'3/1 177 dated the 09/'1212015 vide which an application from M/s Cipla Ltd. was forwarded to this Department for fixation of norms for the export of Azelastine Hydrochloride and Flutic asone Propionate Nasal Spray, pack size 201\i1t) and 28MD. This departmertt has exan'lined the matter and the following norms are recommended against this application - (1) Exoort item: Azelastine Hydrochloride and lluticasone Nasal spray (120MD) pack lmport recommended for 1 16.aamg 6 Omg Relevant pollcy Relevant, as per packing olicy

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(2) ExDort item: Azelastine Hcl + Fluticasone nasal sprey (28N/D) pack. lmport recommended for 1 No Azelastine Hcl Fluticasone 140 mcl pumps Relevant. as per packrng '10 R DlN, USP type amber lubular glass vial Relevant, as per packing Nasal actuator Relevant, as per packrng 2 This issues with the approval of Director (Pharma lndustry). . (Rajkum-a0 Under Secretary to the Government of lndia Phonei 23071162 Department of Commerce. (Shri M V Singh, FTDO) Udyog Bhawan, New Delhr q: r.rb

, ヘ

F No 35011/6202015P:(Norm9 GovL・rnment OFlndia Ministrv ol Chemicals&Fertl zers DepartぃlP1lt OF Pharnlaceut cals lσ lイν"→` Udyo8 thawan, Nevv Deth , oated rhe lltstanrrary, 2Ltr6 Ollice Mentorandunl

Subject:'Fixation of nornls Under para 4 7 ol H.r,til Book of procedures (Vot l) 2009 t4 Ca5e of tJ,t

CIPLA LTD. The uIdfrsiSned is direcred to refer ro DCFT U.o. No. 01/82 /a5A/O1OAO/AM 16lDES t/1165 dated the 08/12/20I5 vide,,vhi.tr apptcation ko,I M/s CtpLA LTD. was sent to this DeprrtnreIr tor fixation of norn)t t]nder para: 4 7 for the erl)(I I of ABACARVTR SULFA fE AND LAMTVUD Nt DtSpEUStBLt TABLETS This det)arlrnent ltdt ex.nrinecl the niirtter and the following rro ns are fllnrjstrecl unrler pnra 4 7 of Han(l 8ooL ,)i Procedur ir5 (Vol 1)200!l l1: (a) No Tablet Export Pr odUct 3/,4o. 299- lim vLrAtne l0 6nrB tlorms for f aoaiarul. .4f"t" 61.2nrg ハbatavir 5ulfate&181η ivt dine dis]e「sible tablets 59'Ug99qs !! qra l:!!qels..r.qn Abacavir sulfate 600m9 + lamiv0dine AbacaⅢrsuratgoo ng二些, Abacavir sulfate dispersible tablets 60mg for oral suspension 612.0m9 306 0mg 61 2mg (C) Directorate General of Forei8n Trade, (shri M.V. Sin8h, FTDO), Udyog Bhawa , New Delhi S No lmport ltem Norms Recommended Ior 1kg Abacavir 5ulfate FOrman dO amino d ch Oro pylm d ne(FADCP) ―――――」:942k8_ __ ____,21`3 _ 0 19kg 2 l4"l!v!3r!i!Ltq" CycJopropyl amine 3 S No Ixport P.odoct Norms Recommended for 1kg Lamivudine 1 (1'R,2′ S.5′ R)menthy:5S(cytOSine l''‐ VL)1′ 3‐oxathioiane‐ 2R― 2 19kg 2 Sodium borobydride 0 48kg 11綺 Under Secretary to the Government of tndia PhOnei 23071162 1 S No ‐ ２匿 306 01η g N ll‖ {

‘ 〈め ‐ ′ ′ ′ が F. No 35011/435/2015 Pl (Norms) Government of lndia lMinistry of Chemical & Fertilizers Department of Pharmaceulicals I4. /eg -...- Udyog Bhawan, New Delhi, Dated: 11 january, 20'16 Office Memorandum Sub: Fixation ol norms under pata 4.7 ol Hand Book of Procedures (Vol.l) 2009-14, Application of M/s Cipla Ltd. The undersigned is directed to refer to DGFT U.O. No. 01l82l50l1064lAM'16/DES,3/1159 dated the 08/1212015 vide which an appticatron from M/s Cipla Ltd. was forwarded to this Department for fixation of norms for the export of Esomeprazole magnesium DR capsules 20mg and 4omg. This department has examined the matter and the following norms are recommended against this application:- lmpod item SMK(S)5-methoxy 21K4-methoxy 3, 5-dimethyl-2-pyridinyl)methyll , sulfinyll-benzimidazole potassium 54.504m9/40mq capsule 2 This issues with the approval of Director (Pharma lndustry) Under Secretary to the Government oi lndia Phone: 23071162 (Shri lr4 V Singh, FTDO), SNo 2

t5l4N1-lb F. No.35011/620/2015-Pl(Norms) Government oI lndia Ministry of Chemicals & Fe(ilizers Oepartment of Pharmaceutical5 UdyoS Bhawan, New Delhi, Dared the flanuary, 2016 Office Memorandum Subjecti Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/5 CIPTA LTD, The undersigned is directed to refer to DGFT U.O. No. 01/82l050/01080/AM-16/DES-3/1165 dated the 08/12/2015 vide which application from M/s CIPIA LTD. was sent to this Department for fixation of norms under para: 4.7 for the export of ABACARVTR SULFATE AND LAMTVUDTNE DtSPERStBLt TABLETS. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009'14:- (A) Export Product Norms lor 1 No. Tablet Abacavir sulfate & lamivudine dispersible tablets 60mB/30m9 for oral suspensron Abacavir sulfate 60Omg + lamivudine 300ma tablets Abacavir sulfate 300m9 tablets 306.0m8 Abacavir sulfate dispersible tablets 60mg for oral suspension 61.2m9 lmport ltem Abacarvir sulfate 61.2m9 612.0m8 lamivudine 3O.6mg 306 0mg Nil Nil (3) (C) Norms Recommended for 1kg Abacavir sulfate 1.042k9 Formamido amino dichloro pyrimidine(FADCP) Methylene chloride (1'R,2'S,5'R)-menthyl 5S-(cytosine r" vU:r,: oatf,iot'"-Zn- 2.19k8 0.48k8 5.25k8 0.19k9 Under Secretary to the Government of lndia Phone:- 23071162 (Shri M.V. Sinsh, FIDo), Norms Recommended lor 1kg Lamivudine carboxylate/CME compound Sodium borobydride Export Product ■ 　２一よ一４ l

1e lA,"-l(. F. No.35011/620/2015-Pl(Norms) Government of lndia Ministry of Chemicals & Fertilizers 9/, */2. Jet Udyog Bhawan, New Delhi, Dated the ||fr JanuarY, 2016 Ollice Memorandum

Subject:- Fixation ot norms under para 4.7 of Hand Book of procedures (Vol.1) 2OO9-14 Case of M/s

CIPLA I.TD. The undersitned is directed to refer to DGFT u.o. No. 01/82/050/01081/AM 16/DE5-3/1153 dated the 08/12/2015 vide which apptication from M/s CtpLA LID. was sent to this Department for fixation of norms under para: 4.7 for the export of ABACARVIR SUTFATE AND LAMTVUDTNE DtSpERStBLE TABI,ETS. This department has examined the matter and the followinB norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1)2009-14i (a) S No Expo( 1 tamivv!ine 15qmg tablet Lamivudine oral solution 50mg/S 2 3 4 Lamivudine oral solution 50mg/5 Lamivudine 100mg tablet 5 6 7 ＆　一，　一 10 11 12 Lamivudine 150m8 + zldovudine 3 Lamivudine 300m9 tablet Lamivudine 150m8 + zidovudine 3 tablet Lamivudine 30mB + zidovudine 50 tablet for oral suspension Lamivudine 150m9 + stavudine 3C tablet(Lamivudine s-30 tablet) LamivLrdine 30mg + stavudine 6mj (L"mivudine s. baby) Lamivudjne 60mg + stavudine 12n (Lamavudine s. junior) Lamivudine 30mR + zidovudine 60 13 Lamivudine 150m8+stavudine 30 tablet Lamivudine 150mg+stavudine 40 tablet 14 15 Stavudine 6m8+Lamivudine 30m tablet 16 Stavudine 12mg + Lamivudine 60 tablet Norms Ior 1No. Tablet or Bottle n」100ml bOtue :l),240ml bott e Qty Recommended 153.0m9 1q?0.0ms 24480m8 102 0mg 00mg tablet 300m9 + nevarapine 200m9 mg + nevirapine 50mg 30mg bilayer 6mg bilayer tablet mg balayer tablet mg tablet mg + nevirapine 200m9 mg + nevirapine 200m8 I + nevirapine S0m8 do ８　８　８ｍ　ｍ一ｍ０　０　０５３０６一５３１ ■ 　ヽ３　１ ● 30.6mg 153 0mg 30 6mg 61 2mg 153.0m9 153.0m9 l0.6mB 上Ｔ ⊥ Lamivudine -do- -d9- -do- mB + nevirapine lmmB ‐do 612m8 ―do― ‐do‐ ＾ｄＯ．　　一・ｄＯ．・ｄ。　一・ｄ。　　・ｄ。「 ― ― コ「 ― ― コ

qty. Recommended for [amivudine 2 19kg 珂 2 3 4 Sodium Borohydride 048k8 1 9849kg 0 832kg Dipotassium Hydrogen Phosphate ]ILelltyla[]!9 Ethylacetate 0575k8 1795k8 Under Secretary to the Government of lndia Phoner- 23071162 Directorate Ceneral of Foreign Trade′ Department or Commerce′ (Sh●M V Singh,FTDOL Udyo8 Bhawan,New Delhi acid

Government oflnd a Dep酬‖ :ミさ麒撚層悶席RicJs 夕^ノ` f2ノと Subjectr Advance Authorization application from import of raw material against the export FREE), M′s Knshna Antoxidants Pvt Ltd fOr the of TRlS TRIDECYL PHOSPHITE(PHENOL (Advance Autho「ization No 0310798022 dated 7 8 2015) Ref: UO No 01′83′50′01071/AM-16′DES I‖′1203 dated 9 12 2015 M/s.KrishnaAntioxidantsPvt,Ltd'havesubmittedpresentapplicationfortheimportof raw material against the export of TRIS TRIDECYL PHOSPHITE (PHENOL FREE)' The application has been examined and the Department recommends the following norms tor the present Advance Authorization application' This issues with the approval of competent authority Addl industttal Adviser Tel No 011‐23381430 Item of lmport l hem of ExpOrt 4 TR METHYL PHOSPHITE TRIS TRIDECYL PHOSPHITE (PHENOしFREE) 2 TR:DECYL ALCOHOL (A K ACARWAL) IM Deptt of C&PC U O No 14010′ 100′2012‐CHJl dated ヽ 012016

F No 14010/96′ 2011‐CH‐ ‖ Govemmentof nd a Min stry of Chem cals and Fert‖ izers Department of Chem ca s and Petrochemicals r″。 ?ノ 1)―― Shastr Bhavan,New Delhi‐ 110001 Dated: 30い December,2015 To, ELPPE CHEMICAL PVT LTD. 63/2,MIDC AREA,DHATAV,ROHA. D:Sπ RAIGAD. MAHARASHTRA402116 Sublectl‐ Advance AuthonzaJOn App“ caJOn for the import of raw―mate百als aga nst the export of NICLOSAMlDE TECHNICAL IAdvance Authorzation No 0310798096 dated 14 8 2015) l al¬ directed to refer to your Advance Autho南zat on appl cation received th「ough Ofrce of DGFT on the subled mentioned above ln th s connection,you are requested to submttthe fol owing informa‖ on w"h n 15 days Ofthe ssue ofth sletter 2 3 1 Detailed manufacturing process with balanced chemical reactions indicating number of moles of all the reactants, products and by-products witi corresponding molecular Formulae, structural formulae, molecular weight and process flow diagram. Stage-wise percentage yield with respect of each of the reactants and products and the relevant justilication enclosing therewith authentic printed technical literature in support of yield / quantity of items for import. Details of production of export product under reference and corresponding consumption oI raw material in the year 2014-15 and 20.15-16 (April to November) duly certified by CA may be furnished. Any other relevant information, if any_ 4 体K鰈ゞ Addl lndustnal Adviser TeL No 011‐23381430 勁ツ “ 胤蹴諾瑞:器翠‖ /W」腑]彬猟「におЮ n∝ゎ DGFT/UON∝

F No 14010′ 86′2015-CH I Goveinment ofind a M n stry of chem ca s and Fer1l zers Department Of Chemica s and Petrochemica s ,〃″ 多ノ, Shastri thavan, New Oethi110001 Dated: 3Os December,2015 To. .,/eun ove cxeu pw rro .rr'c-t-e, steo ruo 48,49 &so. stLVASA \A ROAD, LIC SEcToR, GIDo, VAPI, GUJAMT 396195 Subjecl: Application from HEMA oYE CHEM PW.LTD for the import of raw-materiat against the export of 2-CHLORO-1,4-DIMETHOXY BENZENE (Advance Authorization No. 0310798'134 dated 13.8.2015) I am directed to refer to your Advance Authorization application received through Office of DGFT on the subject mentioned above. ln this connection, you are requested to submit the following information within 15 days ofthe issue ofthas letter.

Detailed manufacluring process, material balance with balanced chemical reactions indicating stage-wise percentage yield along with the technical justification enclosing therewith authentic printed technical literature in support of yield or quantity of items for import.
Details of production of export under reference and corresponding consumption of raw materials in the year 2014.-15 and 2015-16 (April to September) duly certifled by CA may be furnished.
Any other relevant information Yours faithfully, 'ス1, (A K ACARWAL) AddL Industrial Adviser TcI No 011‐ 23381430 Copv to: ンバ怒鵡 ;W鷺書計Υ尻ぼ出FTDO oESユDGF7UONo Oん2前 “ Oη AM

9)-1. 32?,125, 12
Governmeni of lndia Dep鮒‖:需鼎錦:梨S∬霧1耗icJs ヽ堆Ｚ／ヽタ ′ 、のアルタフクι プ′f Ref: U.O. No. 01/8ZO5O l2gg' 301'g1'72.1054,1108,1125'1126/AM16/DES-|lU343' dated 2.O7.2015 M/s. Payal Petro Chemicals Ltd. have submitted present applications lor the import of ralY -material against the export of Di- Octyt Phthalate (DOTPy Di-2EthylHexyl Phthalate/DoP/ Di- ISO BUIYI Phthalate TheaoolicationshavebeenexaminedandtheDepartmentrecommendsthefollowing norms for the present Advance Authorizatlon appllcations' Sublect Advance AuthoHzauon applCa10n from of raw material against the expOrt of Phthalate′ DOP′ Di‐ ISO Butyl Phthalate etc inis is-sues witn tne "pproval of competent authority M′s Paya Petrochem Pvt Ltd fOrthe impOrt D卜 Octy Phthalate(DOTP)′ D12EthyIHeXyl Add1 lndustr al AdviSer Tel No 011-23381430 l tem of

Pure Terephthalic Acid Oi- Octyl Terephthalate 2 2-Ethyl Hexanol l Phthalic Anhyd百de PlaslcizerPVC(DI 2EthylHeXyl Phtha ate′ DOP) Z 2- Ettryl Hexanol (Octanol) 3 kem of Exp咀 Qty Item of lmport Qty D1 lSO Butyl Phthalate (DIBP) l kg I Phthalc Anhyd商de 0 560 kg
lso Butanol 0 560 kg Deptt. oI C&PC U.O. No. Mehender V 6K颯ゞ

|ダlρ “ ―lι I' No 350111659,2012-Pl(NOnll、 ) g′ ″ o´ ′|る Govemment oflndia

Ministry ofchemical & Fe(ilizers Udyog Bhawan, New Delhi. the l2rh March. 2013 Office Memorandum

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

of M/s. Clenmark Generics Ltd. The undersigned is directed to refer to DGFT U.O.No. 0l/82/50/63E/AM l3IDES-3/826 datcd thc 04/10/12 vide which an application from M/s. Clenmark Cenerics Ltd was sent to this l)epartment for fixation of norms under para: 4.7 lor the export of Olmesartan M€doxomill. This dcpartment has examined the matter and the following comments are lumished under para 4.7 ofHand Book ofProcedures (Vol.l) 2009-l4i S No lnrporl Ilcn1 l 4-(l― HydrOxy-1-Mcthyl Ethyl)-2-Propyl l H Imida201e S―Carboxylic Acid Ethyl Ester 078 , 5‐ (4‐ Bromomcthyり(11‐ BrOmomcthyl)2YL Triphcnyト 1-H l ctrazolc 1 786 ♪ l-Chloromethyl-5-Methyl- 1.3-dioxolen-2-one 048 4 Dimcthyl f-ormamide 672 ) I etrahydrol'urilD 343 ′ ０ Potassium Carbolralc 057 7 Tolucnc 241 l. This issues with the approval of Director (Cos0. oヾN AhЧ ia) Scct on Ofl ccr I■‐Norms I)ircctorate General oI Foreign Trade. l)epartment of Commerce. (Mrs. Lalita Maini. FTDO). tldyog Bhawan, New Delhi.

F No 14010/36′ 2011-CH II Government oflndia Min stry of chemica s and Fert‖ zers Department of Chemicals and Petrochemioals ヱスる‐ S(。 Sublect: Advance Authonza10n app calon from M′ s KL」Plasuc zers Ltd for the import ofraw mate“ a aga nstthe expOrl of KANATOL`00(N) Advance Authorzaton No 510395469 dated 28 8 2015 Ref: U O No 01′ 82′ 050′ 01037′ AM16′DES l‖′1199 dated,422015 M/s KL」Plasticizers Ltd have submited present app catons forthe import of raw materal againstthe export of KANATOL-400(N) The app cato嗜^have been examined and the Department recommends the fo‖ owing norms forthe present Advance Autho「 zaton app‖ cations

ltem of Export Qtv Item of lmport Qtv KANATOL-400(N) l kg PHTHALiC ANHYDR:DE 0 560 kg NORMAL BUTANOL 0 550 kg This issues with the approval of competent authority. てム、ィ AddL Industr al Advise「 Tel No 011-23381430 shn Mahender V kram S nqh FTDO (DESJID O′ O DGFT Udvoq Bhawan New De hi-11 Deptt Of C&PC U O No 14010/36′ 2041-CH ldated 21 12 2015 体K AG鎌ヽ嶺と｀

Government of lndia Ministry of Chemicals and Fertilizers Department of Chemicals€nd Petrochemicals CX/・質し

Subject: Advance Authorization application from M/s. GUJAMT ORGANICS LTD' for the

import of raw material against the exporl of PARA ISO PRoPOXY ETHYL BENZOATE, (Advance Authorization No.0310798598 dated 01.09.2015) Ref: U.O. No. 01/82lO5O/01086/AM16/DES-|lu'l 166 dated 08. 1 2.201 5 M/s. GUJAMT ORGANICS LTD have submitted present application for the imporl of raw material against the export ol PARA ISO PROPOXY ETHYL BENZOATE. The application has been examined and the Oepartment recommends the following norms lor the present Advance Authorization application. '1. ltem of Export Qty Item of lmport Qty PARA lSO PROPOXY ETHYL BENZOATE l KG l PARA HYDROXY BENZOIC ACID 1 010 KG 2 1SO PROPYL BROMIDE 1 254 KG This issue with the approval of competent authority. (A K AGARWAL) Addl lndustttal Adv ser Tel No 011‐23381430 帥呻 0′o of C&PC U O No 14010′ 11′2013-CH‐ ‖dated 1 01 2016

Government ofind a Dep器:P諾脚留ξ∬殿」晶:icJs "ん ´アメ Subject: AdvanceAuthorizationapplication the import of raw material against the export of from M/s Survival Technologies Pvt Ltd for Trimethylsilyl Trifl uoromethane Sulfonate ″ Ref: U.O. No. O1/82/o5O/895/ AM- 16/946, dated 9 9.2015 (Advance Authorization No.0310797796 dated 17'1'2015) M/s Survival Technologies Pvt. Ltd have submitted present application for the import of raw material against the export of Trimethylsilyl Trifluoromethane Sulfonate The application has been examined and the Department recommends the following norms for the present Advance Authorization application. l ltem of ExpOrt Qty Item of lmport Qty Trimethylsilyl Trifluoromethane Sulfonate l kg 4 TRIFLIC ACID (T百1uo「o methane Sulfonic Ac d) 0 892 kg This issues with the approval of competent authority. AddL industrial Adviser Tel No 011‐23381430 n Deptt Of C&PC u O No 14010′ 62′2010-CH ldated 19102045 i ヽ 1●hond●′V krnm Sinah rDES‐ ‖ヽ0′o DGFT U (AK

′ξノ /1ρ )‐ ノメ F. No.350l I /536/201 5-Pl (Norms) Governmenl oflndia Departmenl of Pharmaceuticals Udyog Bhawan, New Delhi. the December. 2015 Office Memorandum Subiect: - F ixation of norms under para 4.7 of lland Book of Procedures (Vol.l) 2009- l4 Case of M/s Aurohindo Pharma Ltd 'lhc undersigned is direcled to reler to DGFT LJ.O.No. 0l /82/50/605/AM- l6/DES- .l/1017 datcd thc 27110/15 vide which application liom M/s. Aurobindo Pharma Ltd was sent to lhis Department lbr tixation of norms under paru:- 4.7 fot the export of Amoxicillin Trihydrate. 'lhis department has examined the matter and the following norms are furnished undcr para 4.7 ol'Hand Book ofProcedures (Vol.l) 2009-14:- 2 . T h is issucs with the approval of com pctcnt autho rity. (Raj Kumar) Under Secretary to the Covemment oflndia Phone:23071 162 I)ircctomte General of Foreign Trade. I )cpartmenl of Clommerce, (Shri M.V. Singh. FTDO), lJdyog Bhawan. New Delhi g,./"- 33 3 S No Impofl Irem Qt)'. Recommended kg,/k8. | 5-APA(6-Amino Penicillanic Acid) 0568 Melhyl D1-)-4-Hydroxy'PhenylglycinateOr D-(-)-4- lJydroxyphenylglycine Methyl Ester IPHPC Ester] 0507 , Penicillin C Amidase (Particle size 250-500 Micron) 0002 lsopropylAlcohol 022,

ts f an-rc Udyog Bhawan, New Delhi. the 26'h Seprember, 2013 Office Memorandum Suhjcct: - Fixation ofnorms under para 4.7 of Hand Book of procedures (Vol.l) 2009_14 Case of M/s Suven Life Sciences Ltd. 'I he undersigned is directed lo refer to DCFT U.O.No. 0l/82/50/t6U AMI4/DES_3/2I2 datcd the 26107lll vide which representation from l.,l/s. Suven Life Sciences Ltd was senl to lhis Department lor fixation of norms under paru 4.1 tbt the expon of Methyl (E)2(2_ Chlommethylphenyl)-3-Methoxy Acrylate. This department has examined the matter and the tbllowing norms are lumished under para 4.7 of Hand Book ofprocedures (Vol.l) 2009_14:_ , This issues with the approval ofDirector (Cost). (Raj Kumar) Under Secrelary to the Govemment oflndia pl-Norms I)irectomte General of Foreign Trade. I)Irpartmcnt of Commerce, (Shri l(.C. Meena. Dy. D(iF"l). tldyoS Bhawan. New Delhi. ヽN() Import ltem Qty. Recommended kg,&g. | Ortho Tolyl Acetic Acid 156 つ Sulfuryl Chloride 1 986 p Polassium lodide 00080 4 Thion-""1 Chloride 1 24 ＦＩＩに ― ― トーートーートー

1514"''Y F. No.350l l/228/2015-PI (Norms) Covernment of lndia Ministry of Chemicals & Fertilizers Departmenl of Pharmaceuticals Udyog Bhawan.New Delhi, Dated the October. 2015 OIfice Memorandum Suhiect: - Fixation ofnorms under para 4.7 ofHand 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. 0l/82/50/ I 339/AM- I5,DES- 3/1364 dated the l0/03/15 vide which application from M/s. Mylan Labs Ltd was sent to this Department for fixation of norms under pa'at 4.7 for the export of (S|.Pregabalio. This department has examined the maner and it is requested that DGFT may call following technical details from lhe firm viz:- (c) Complete technical delailas per Appendix-33. (d) Past production vis-d-vis Aclual consumption of imported inputs duly cenified by Central Excise Authorities. (Barnali Khastgir) Under Secretary lo the Govemment oflndia Phone:2307t I62 Directorate Ceneral of Foreign Trade. Depaflment ofCommerce, lShri M.V. Singh. F f DO), tldyog Bhawan. New Delhi qrlo' 4/\

A ,<)a--lt Ir. No.350ll1ll4/1011 PI (Norrns) (ior clrrnclt ol lndia lVlinistlr ol Chcmical & Ircrtilizcls f)epal'1Drcn1 ol Pharutaceuticals t7'oz- Udyog tlhawan, New Dclhi, the lf December, 201 5 Olllce Memolandum

Subject: - liixation of norrns undcr para 4.7 of Hand Book of Proccdurcs (Vol.l)

2009-14 Casc ol'M/s Pharma Zcll India Pvt Ltd. The undersigned is directed to refer to DGFT U.O.No.0l/82/16?/l3ll/AM- I 5/DLrS-3/1449 dated thc l6103/l 5 vide which application from M/s. Phanna Zcll India Pvt [-td was scnt to this Dcpartment lbr fixation of nonrs Lrnder pat.a: 4.7 fbr the expolt ol'Dehydro Cholic Acid (DHCA). This depatunent has examined thc mattcr and thc lbllowing norms arc f-urnishcd under para 4.7 of I land Ilook ol Pt'occdules (Vol.l ) 2009 - I 4:- Inrport lterr Qty. Recorrnrenclerl kg/kg. bilc I)astc 'Ihis issucs wilh the approval ofcontpetcnl aulhority. lJndcr Sc-cretaty to thc Governmcnl ol'lndia Phone:2i071 1(>l Direcbrate Ge[elal ol'Foleign I radc, Dcpaft ment of Corlntercc, (Shri M.V. Singh, F'l l)O). [ )dyog Bhawan, Neu, Delhi ハ lsヽこ l う一

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