IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2016-04-07

DGFT Committee Minutes

Document text

Office of Directorate General of Foreign Trade
New Delhi -0

Para 4.7 Decision

Meeting No. 01/82/2016 of 2016-17, 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, held on 07.04.2016 under the Chairmanship of Dr. S.K. Bansal, Jt. DGFT in Room No.107, Udyog Bhawan, New Delhi.

Following members were present:-

Shri D.N.Mathur, Consultant, D/o Pharmaceuticals. Shri M.V. Singh, FTDO, DGFT

The committee went through the minutes of earlier NC-III meeting No. 21/82 was held 22.03.2016 and approved the same.

Note: In certain cases the decision of the Norms Committee refers to the Recommendations/ Observations / Deficiencies received from the concerned Technical authority in the same case or a different case of another firm with the same product. A scanned copy of such document is placed at the end of the Minutes. In some cases, the scanned copy uploaded may be unsigned.
In both these instances, the scanned copy uploaded is to be accepted. MEETING NUMBER
: 1/82-ALC4/2016 MEETING DATE : 07.04.2016

Case No.:11/20/82-

ALC4/2015
Party Name:PROMED EXPORTS PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01594/AM16/
RLA File :05/24/040/00377/AM12/
Lic.No/Date:0510315841 30.01.2012 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/520/2015-PI(Norms) dated 18.01.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No.:173/14/82-

ALC4/2015
Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01309/AM16/
RLA File :03/95/040/00881/AM10/
Lic.No/Date:0310726567 04.03.2013 Defer Date:12.05.2016 Decision: Deferred.

Case No.:16/1/82-

ALC1/2016
Party Name:AUCTUS PHARMA LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01790/AM16/
RLA File :09/24/040/00564/AM13/
Lic.No/Date:0910055281 05.03.2013 Defer Date:12.05.2016 Decision : The Committee decided to defer the case for want of comments of DoP.

Case No.:113/14/82-

ALC4/2013
Party Name:PARAMOUNT AROMACHEM PVT.LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00698/AM14/
RLA File :05/24/040/00488/AM13/
Lic.No/Date:0510350269 26.03.2013 Defer Date:12.05.2016 Decision : Deferred.

Case No.:29/1/82-

ALC1/2016
Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01803/AM16/
RLA File :07/24/040/00397/AM14/
Lic.No/Date:0710103004 19.03.2014 Defer Date:12.05.2016

Case No.:52/6/82-

ALC4/2014
Party Name:UPL LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00454/AM15/
RLA File :03/95/040/01043/AM14/
Lic.No/Date:0310776594 01.04.2014 Defer Date:12.05.2016

Case No.:25/1/82-

ALC1/2016
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01799/AM16/
RLA File :09/24/040/00001/AM15/
Lic.No/Date:0910059732 08.04.2014 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/572/2015-PI(Norms) dated December 2015 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No.:1/13/85-

ALC3/2014
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 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 in NC 12 dt. 18.11.2015 at Sl.No.16.

Case No.:1/9/85-ALC3/2014 Party Name:RA CHEM

PHARMA LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/85/050/00067/AM15/
RLA File :09/24/040/00049/AM15/
Lic.No/Date:0910059919 28.04.2014 Defer Date: Decision :Already approved in NC 12 dt. 18.11.2015 at Sl.No.18.

Case No.:238/6/82-

ALC4/2014
Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File RLA File Lic.No/Date:1710005810 Defer Date:

:01/82/050/00640/AM15/
:17/24/040/00008/AM15/
09.05.2014 Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/78/2012-Ch-II dated 4.3.2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No.:121/14/82-

ALC4/2015
Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01257/AM16/
RLA File :17/24/040/00006/AM15/
Lic.No/Date:1710005809 09.05.2014 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/78/2012-Ch-II dated 4.3.2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No.:88/6/82-

ALC4/2014
Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00490/AM15/
RLA File :03/95/040/00033/AM15/
Lic.No/Date:0310782129 20.05.2014 Defer Date:12.05.2016

Case No.:55/20/82-

ALC4/2015
Party Name:INDO PHYTO CHEMICALS PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01638/AM16/
RLA File :05/23/040/00082/AM15/
Lic.No/Date:0510387611 28.05.2014 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/683/2015-PI(Norms) dated 21.03.2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No.:61/4/82-

ALC4/2014
Party Name:V & V PHARMA INDUSTRIES Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00309/AM15/
RLA File :03/95/040/00190/AM15/
Lic.No/Date:0310785305 13.06.2014 Defer Date:12.05.2016 Decision :Deferred.

Case No.:69/4/82-

ALC4/2014
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00317/AM15/
RLA File :09/24/040/00175/AM15/
Lic.No/Date:0910060550 27.06.2014 Defer Date: 12.05.2016 Decision : The committee noted that copy of application has been called for the firm/RA and the

same is awaited . The committee decided to remind the firm to submit the same and deferred the case.

Case No.:73/9/82-

ALC4/2014
Party Name:D. R. COATS INK & RESINS PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00870/AM15/
RLA File :03/94/040/00755/AM14/
Lic.No/Date:0310786181 30.06.2014 Defer Date:12.05.2016 Decision :Deferred.

Case No.:370/5/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/00510/AM16/
RLA File :09/24/040/00193/AM15/
Lic.No/Date:0910060634 09.07.2014 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/452/2015-PI(Norms) dated 11.04.2016 ,

Case No.:79/9/82-

ALC4/2014
Party Name:METROPOLITAN EXIMCHEM LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00876/AM15/
RLA File :03/95/040/00337/AM15/
Lic.No/Date:0310787073 18.07.2014 Defer Date:12.05.2016 Decision :Deferred.

Case No.:396/5/82-

ALC4/2015
Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00536/AM16/
RLA File :17/24/040/00047/AM15/
Lic.No/Date:1710005887 24.07.2014 Defer Date:12.05.2016

Case No.:32/9/82-

ALC4/2014
Party Name:CHEMCON SPECIALITY CHEMICALS P LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00829/AM15/
RLA File :34/24/040/00102/AM15/
Lic.No/Date:3410040406 28.07.2014 Defer Date:12.05.2016 Decision :Deferred

Case No.:8/6/82-

ALC4/2014
Party Name:V & V PHARMA INDUSTRIES Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00410/AM15/
RLA File :03/95/040/00331/AM15/
Lic.No/Date:0310787382 28.07.2014 Defer Date:12.05.2016 Decision :Deferred.

22 Case No.:58/9/82- ALC4/2014
Party Name:G AMPHRAY LABORATORIES, Meet No/Date:1/82- ALC4/2016 Status:Case Deferred

07.04.2016 HQ File :01/82/050/00855/AM15/
RLA File :03/94/040/00171/AM15/
Lic.No/Date:0310787536 01.08.2014 Defer Date:12.05.2016 Decision : The committee noted that copy of application has been called for the firm/RA and the same is awaited . The committee decided to remind the firm to submit the same and deferred the case.

Case No.:49/9/82-

ALC4/2014
Party Name:SANMAR SPECIALITY CHEMICALS LIMITED, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00846/AM15/
RLA File :04/24/040/00106/AM15/
Lic.No/Date:0410159125 01.08.2014 Defer Date:12.05.2016 Decision :Deferred.

Case No.:31/9/82-

ALC4/2014
Party Name:AMBERNATH ORGANICS PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00828/AM15/
RLA File :03/94/040/00074/AM15/
Lic.No/Date:0310787610 04.08.2014 Defer Date:12.05.2016 Decision :Deferred.

Case No.:2/14/82-

ALC4/2015
Party Name:SHREE SHIVSHANKAR DRUGS & PHARMACEUTICALS P. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01138/AM16/
RLA File :03/95/040/00425/AM15/
Lic.No/Date:0310788055 14.08.2014 Defer Date:12.05.2016 Decision :Deferred.

Case No.:48/5/82-

ALC4/2015
Party Name:VISION DRUGS PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00188/AM16/
RLA File :09/24/040/00260/AM15/
Lic.No/Date:0910060860 18.08.2014 Defer Date:12.05.2016 Decision : The Committee noted that information had been called for from the firm in NC meeting No.18 dated 10.02.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case.

Case No.:215/13/82-

ALC4/2014
Party Name:GOLD STAR CHEMICALS PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01218/AM15/
RLA File :03/94/040/00358/AM15/
Lic.No/Date:0310788338 25.08.2014 Defer Date:12.05.2016 Decision :Deferred.

Case No.:264/13/82-

ALC4/2014
Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01267/AM15/
RLA File :03/94/040/00405/AM15/
Lic.No/Date:0310788397 26.08.2014 Defer Date:12.05.2016

Decision :Deferred

Case No.:255/13/82-

ALC4/2014
Party Name:THE DHARAMSI MORARJI CHEMICAL CO LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01258/AM15/
RLA File :03/95/040/00431/AM15/
Lic.No/Date:0310788373 26.08.2014 Defer Date:12.06.2016 Decision :Deferred.

Case No.:377/5/82-

ALC4/2015
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00517/AM16/
RLA File :03/94/040/00493/AM15/
Lic.No/Date:0310788472 27.08.2014 Defer Date:12.05.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals forwarded vide O.M.No.35011/506/2015-PI(Norms) dated 30.12.2015, uploaded at the end of these minutes decided to call for technical information from the firm and deferred the case.

Case No.:224/13/82-

ALC4/2014
Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01227/AM15/
RLA File :03/94/040/00391/AM15/
Lic.No/Date:0310788515 28.08.2014 Defer Date:12.05.2016 Decision :Deferred.

Case No.:225/13/82-

ALC4/2014
Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01228/AM15/
RLA File :03/94/040/00397/AM15/
Lic.No/Date:0310788514 28.08.2014 Defer Date:12.05.2016 Decision :Deferred

Case No.:262/13/82-

ALC4/2014
Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01265/AM15/
RLA File :03/94/040/00971/AM14/
Lic.No/Date:0310788560 01.09.2014 Defer Date:12.05.2016 Decision :Deferred.

Case No.:263/13/82-

ALC4/2014
Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01266/AM15/
RLA File :03/94/040/00962/AM14/
Lic.No/Date:0310788558 01.09.2014 Defer Date:12.05.2016 Decision :Deferred.

Case No.:223/13/82-

ALC4/2014
Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred

HQ File :01/82/050/01226/AM15/
RLA File :03/94/040/00508/AM15/
Lic.No/Date:0310788647 02.09.2014 Defer Date:12.05.2016 Decision :Deferred.

Case No.:3/7/82-

ALC4/2014
Party Name:S V CHEM INTERMEDIATES P LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00647/AM15/
RLA File :04/24/040/00139/AM15/
Lic.No/Date:0410159328 02.09.2014 Defer Date:12.05.2016 Decision :Deferred.

Case No.:400/5/82-

ALC4/2015
Party Name:YASH RASAYAN & CHEMICALS Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00540/AM16/
RLA File :34/24/040/00120/AM15/
Lic.No/Date:3410040554 15.09.2014 Defer Date:12.05.2016 Decision :Deferred.

Case No.:12/15/82-

ALC4/2014
Party Name:JINDAL DRUGS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01299/AM15/
RLA File :03/94/040/00460/AM15/
Lic.No/Date:0310789265 16.09.2014 Defer Date:12.05.2016 Decision :Deferred.

Case No.:380/5/82-

ALC4/2015
Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case
HQ File :01/82/050/00520/AM16/
RLA File :22/24/040/00054/AM15/
Lic.No/Date:2210015086 16.09.2014 Defer Date:12.05.2016 Decision :The Committee deferred the case for want of comments from DoP.

Case No.:59/13/82-

ALC4/2014
Party Name:HELLO PAINTS (P) LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01062/AM15/
RLA File :05/23/040/00276/AM15/
Lic.No/Date:0510391245 19.09.2014 Defer Date:12.05.2016 Decision :Deferred.

Case No.:128/8/82-

ALC4/2014
Party Name:HETERO LABS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/00792/AM15/
RLA File :09/24/040/00341/AM15/
Lic.No/Date:0910061003 22.09.2014 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/145/2015-PI(Norms) dated 11.04.2016 ,

42 Case No.:129/8/82- Party Name:HETERO LABS Meet No/Date:1/82- Status:Case

ALC4/2014
LIMITED ALC4/2016 07.04.2016 Approved HQ File :01/82/050/00793/AM15/
RLA File :09/24/040/00338/AM15/
Lic.No/Date:0910061004 22.09.2014 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/195/2015-PI(Norms) dated 11.04.2016 ,

Case No.:15/13/82-

ALC4/2014
Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 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:12.05.2016 Decision :Deferred.

Case No.:19/1/82-

ALC4/2015
Party Name:GEM AROMATICS PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 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:12.05.2016 Decision :Deferred.

Case No.:372/5/82-

ALC4/2015
Party Name:DR J PHARMACHEM (INDIA)(PROP.ADITYA PRAMOD JOGDEO) Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00512/AM16/
RLA File :31/83/040/00154/AM15/
Lic.No/Date:3110064948 08.10.2014 Defer Date:12.05.2016 Decision :Deferred.

Case No.:29/13/82-

ALC4/2014
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01032/AM15/
RLA File :05/23/040/00268/AM15/
Lic.No/Date:0510391490 08.10.2014 Defer Date:12.05.2016 Decision :Deferred.

Case No.:124/13/82-

ALC4/2014
Party Name:PANACEA BIOTEC LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01127/AM15/
RLA File :05/24/040/00319/AM15/
Lic.No/Date:0510391623 17.10.2014 Defer Date:12.05.2016 Decision : The Committee decided to defer the case for want of comments of DBT.

Case No.:78/10/82-

ALC4/2014
Party Name:HETERO LABS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/00992/AM15/
RLA File :09/24/040/00393/AM15/
Lic.No/Date:0910061130 22.10.2014 Defer Date:

Pharmaceuticals forwarded vide O.M. No.35011/195/2015-PI(Norms) dated 11.04.2016 ,

Case No.:393/5/82-

ALC4/2015
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00533/AM16/
RLA File :09/24/040/00387/AM15/
Lic.No/Date:0910061210 11.11.2014 Defer Date:12.05.2016 No.12 dated 18.11.2015 is awaited. The Committee accordingly decided to await the reply and deferred the case.

Case No.:198/5/82-

ALC4/2015
Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00338/AM16/
RLA File :04/24/040/00205/AM15/
Lic.No/Date:0410159704 11.11.2014 Defer Date:12.05.2016 Decision :Deferred for want of comments of DoP.

Case No.:72/18/82-

ALC4/2014
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01438/AM15/
RLA File :03/94/040/00773/AM15/
Lic.No/Date:0310791044 13.11.2014 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/371/2015-PI(Norms) dated 15.03.2016 ,

Case No.:65/15/82-

ALC4/2014
Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 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:12.05.2016 No.02 dated 29.04.2015 is awaited. The Committee accordingly decided to await the reply and deferred the case.

Case No.:126/8/82-

ALC4/2015
Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00922/AM16/
RLA File :03/94/040/00710/AM15/
Lic.No/Date:0310791177 18.11.2014 Defer Date:12.05.2016 Decision : Deferred

Case No.:52/15/82-

ALC4/2014
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 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:12.05.2016 Decision : The Committee decided to defer the case for want of comments of DOP.

Case No.:355/5/82-

ALC4/2015
Party Name:GRANULES INDIA LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/00495/AM16/
RLA File :09/24/040/00433/AM15/
Lic.No/Date:0910061297 25.11.2014 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/624/2015-PI(Norms) dated 21.03.2016, uploaded

Case No.:43/18/82-

ALC4/2014
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 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:12.05.2016 Decision :Deferred

Case No.:362/5/82-

ALC4/2015
Party Name:KLJ PLASTICIZERS LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00502/AM16/
RLA File :05/23/040/00377/AM15/
Lic.No/Date:0510392211 28.11.2014 Defer Date:12.05.2016 Decision : Deferred

Case No.:154/5/82-

ALC4/2015
Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00294/AM16/
RLA File :03/95/040/00740/AM15/
Lic.No/Date:0310791735 05.12.2014 Defer Date:12.05.2016 No.14 dated 16.12.2015 is awaited. The Committee accordingly decided to await the reply and deferred the case.

Case No.:139/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/00279/AM16/
RLA File :03/94/040/00872/AM15/
Lic.No/Date:0310791890 10.12.2014 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/383/2015-PI(Norms) dated 17.03.2016 ,

Case No.:145/5/82-

ALC4/2015
Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred

HQ File :01/82/050/00285/AM16/
RLA File :03/94/040/00877/AM15/
Lic.No/Date:0310792112 17.12.2014 Defer Date:12.05.2016 Decision :Deferred.

Case No.:1/15/82-

ALC4/2014
Party Name:AUCTUS PHARMA LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01288/AM15/
RLA File :09/24/040/00490/AM15/
Lic.No/Date:0910061407 18.12.2014 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/256/2015-PI(Norms) dated October, 2015,

Case No.:127/5/82-

ALC4/2015
Party Name:EMAMI LIMITED, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00267/AM16/
RLA File :02/24/040/00183/AM15/
Lic.No/Date:0210205355 18.12.2014 Defer Date:12.05.2016

Case No.:133/5/82-

ALC4/2015
Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00273/AM16/
RLA File :03/94/040/00883/AM15/
Lic.No/Date:0310792178 19.12.2014 Defer Date:12.05.2016 Decision : The Committee decided to defer the case for want of comments of DoP..

Case No.:224/5/82-

ALC4/2015
Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00364/AM16/
RLA File :09/24/040/00531/AM15/
Lic.No/Date:0910061427 22.12.2014 Defer Date:12.05.2016 deferred the case.

Case No.:136/5/82-

ALC4/2015
Party Name:AVIGNON EXIM PVT.LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00276/AM16/
RLA File :03/94/040/00843/AM15/
Lic.No/Date:0310792314 23.12.2014 Defer Date:12.05.2016 Decision :Deferred.

Case No.:96/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/00236/AM16/
RLA File :03/94/040/00912/AM15/
Lic.No/Date:0310792310 23.12.2014 Defer Date:

Pharmaceuticals forwarded vide O.M. No.35011/383/2015-PI(Norms) dated 17.03.2016 ,

Case No.:221/5/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00361/AM16/
RLA File :09/24/040/00537/AM15/
Lic.No/Date:0910061442 23.12.2014 Defer Date:12.05.2016 Decision :Deferred.

Case No.:114/5/82-

ALC4/2015
Party Name:NATIONAL TUBE INDUSTRIES, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00254/AM16/
RLA File :03/95/040/00756/AM15/
Lic.No/Date:0310792363 24.12.2014 Defer Date:12.05.2016 Decision :Deferred.

Case No.:218/5/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00358/AM16/
RLA File :09/24/040/00552/AM15/
Lic.No/Date:0910061462 29.12.2014 Defer Date:12.05.2016 Decision :Deferred.

Case No.:99/18/82-

ALC4/2014
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01465/AM15/
RLA File :07/24/040/00302/AM15/
Lic.No/Date:0710107307 30.12.2014 Defer Date:12.05.2016 Decision :Deferred.

Case No.:111/18/82-

ALC4/2014
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01477/AM15/
RLA File :07/24/040/00307/AM15/
Lic.No/Date:0710107306 30.12.2014 Defer Date:12.05.2016 Decision :Deferred.

Case No.:138/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/00278/AM16/
RLA File :03/94/040/00920/AM15/
Lic.No/Date:0310792544 01.01.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/395/2015-PI(Norms) dated 15.03.2016 ,

Case No.:28/7/82-

ALC4/2015
Party Name:PARAMOUNT AROMACHEM PVT.LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00633/AM16/
RLA File :05/24/040/00428/AM15/
Lic.No/Date:0510392678 05.01.2015 Defer Date:12.05.2016 Decision :Deferred.

Case No.:45/5/82-

ALC4/2015
SCIENCES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00185/AM16/
RLA File :09/24/040/00558/AM15/
Lic.No/Date:0910061483 05.01.2015 Defer Date:12.05.2016

Case No.:102/5/82-

ALC4/2015
Party Name:ALTA LABORATORIES LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00242/AM16/
RLA File :03/94/040/00836/AM15/
Lic.No/Date:0310792635 07.01.2015 Defer Date:12.05.2016 Decision :Deferred.

Case No.:74/5/82-

ALC4/2015
Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00214/AM16/
RLA File :03/95/040/00833/AM15/
Lic.No/Date:0310792647 07.01.2015 Defer Date:12.05.2016 Decision :Deferred.

Case No.:149/5/82-

ALC4/2015
Party Name:ALCHEMIE LABORATORIES Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00289/AM16/
RLA File :03/94/040/00813/AM15/
Lic.No/Date:0310792673 08.01.2015 Defer Date:12.05.2016 Decision :Deferred.

Case No.:121/5/82-

ALC4/2015
Party Name:UNIJULES LIFE SCIENCES LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00261/AM16/
RLA File :03/95/040/00835/AM15/
Lic.No/Date:0310792685 08.01.2015 Defer Date:12.05.2016 deferred the case.

Case No.:219/5/82-

ALC4/2015
Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00359/AM16/
RLA File :09/24/040/00549/AM15/
Lic.No/Date:0910061517 09.01.2015 Defer Date:12.05.2016

Decision :Deferred.

Case No.:239/5/82-

ALC4/2015
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00379/AM16/
RLA File :09/24/040/00555/AM15/
Lic.No/Date:0910061520 09.01.2015 Defer Date:12.05.2016 deferred the case.

Case No.:141/5/82-

ALC4/2015
Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00281/AM16/
RLA File :03/94/040/00746/AM15/
Lic.No/Date:0310792870 13.01.2015 Defer Date:12.05.2016

Case No.:119/5/82-

ALC4/2015
Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00259/AM16/
RLA File :03/95/040/00843/AM15/
Lic.No/Date:0310792869 13.01.2015 Defer Date:12.05.2016 deferred the case.

Case No.:59/5/82-

ALC4/2015
Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00199/AM16/
RLA File :03/94/040/00793/AM15/
Lic.No/Date:0310792911 14.01.2015 Defer Date:12.05.2016 deferred the case

Case No.:243/5/82-

ALC4/2015
SCIENCES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00383/AM16/
RLA File :09/24/040/00589/AM15/
Lic.No/Date:0910061530 14.01.2015 Defer Date:12.05.2016 deferred the case

Case No.:88/5/82-

ALC4/2015
Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00228/AM16/
RLA File :05/23/040/00486/AM15/
Lic.No/Date:0510392949 21.01.2015 Defer Date:12.05.2016 Decision : The Committee decided to defer the case for want of comments of Department of

AYUSH.

Case No.:269/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/00409/AM16/
RLA File :03/94/040/01006/AM15/
Lic.No/Date:0310793301 27.01.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/396/2015-PI(Norms) dated 17.03.2016, uploaded

Case No.:163/5/82-

ALC4/2015
Party Name:RANBAXY LABORATORIES LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00303/AM16/
RLA File :05/24/040/00503/AM15/
Lic.No/Date:0510393026 29.01.2015 Defer Date:12.05.2016 deferred the case

Case No.:138/8/82-

ALC4/2015
Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00934/AM16/
RLA File :03/94/040/01099/AM14/
Lic.No/Date:0310793426 30.01.2015 Defer Date:12.05.2016 deferred the case.

Case No.:275/5/82-

ALC4/2015
Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00415/AM16/
RLA File :03/94/040/00930/AM15/
Lic.No/Date:0310793539 03.02.2015 Defer Date:12.05.2016 Decision :Deferred.

Case No.:284/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/00424/AM16/
RLA File :03/94/040/01053/AM15/
Lic.No/Date:0310793620 05.02.2015 Defer Date: Pharmaceuticals forwarded vide O.M.35011/383/2015-PI(Norms) dated 17.3.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No.:169/5/82-

ALC4/2015
Party Name:TIDE INDUSTRIES Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00309/AM16/
RLA File :34/24/040/00290/AM15/
Lic.No/Date:3410040927 05.02.2015 Defer Date:12.05.2016 deferred the case.

Case No.:333/5/82-

ALC4/2015
Party Name:MEHTA API PVT LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/00473/AM16/
RLA File :03/95/040/00903/AM15/
Lic.No/Date:0310793861 12.02.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/430/2015-PI(Norms) dated 29.03.2016 , of HBP Vol.1. RA concerned may take necessary action as per decision of NC

Case No.:283/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/00423/AM16/
RLA File :03/94/040/01084/AM15/
Lic.No/Date:0310793953 18.02.2015 Defer Date: Pharmaceuticals forwarded vide O.M.35011/383/2015-PI(Norms) dated 17.3.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No.:279/5/82-

ALC4/2015
Party Name:CROWN CHEMICALS PVT.LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00419/AM16/
RLA File :03/94/040/01088/AM15/
Lic.No/Date:0310793983 19.02.2015 Defer Date:12.05.2016 Decision :Deferred.

Case No.:288/5/82-

ALC4/2015
Party Name:CROWN CHEMICALS PVT.LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00428/AM16/
RLA File :03/94/040/01089/AM15/
Lic.No/Date:0310793982 19.02.2015 Defer Date:12.05.2016 Decision :Deferred.

Case No.:332/5/82-

ALC4/2015
Party Name:O C SPECIALITIES PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00472/AM16/
RLA File :03/95/040/00991/AM15/
Lic.No/Date:0310794000 19.02.2015 Defer Date:12.05.2016 Decision :Deferred.

Case No.:335/5/82-

ALC4/2015
Party Name:PRIVI ORGANICS LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00475/AM16/
RLA File :03/95/040/00978/AM15/
Lic.No/Date:0310794038 20.02.2015 Defer Date:12.05.2016 Decision :Deferred.

Case No.:280/5/82-

ALC4/2015
Party Name:FERMENTA BIOTECH LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00420/AM16/
RLA File :03/94/040/01110/AM15/
Lic.No/Date:0310794101 24.02.2015 Defer Date:12.05.2016 deferred the case.

Case No.:232/5/82-

ALC4/2015
Party Name:RANBAXY LABORATORIES LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/00372/AM16/
RLA File :05/24/040/00560/AM15/
Lic.No/Date:0510393348 24.02.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/365/2015-PI(Norms) dated 19.11.2015, uploaded

100

Case No.:334/5/82-

ALC4/2015
Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00474/AM16/
RLA File :03/95/040/00862/AM15/
Lic.No/Date:0310794100 24.02.2015 Defer Date:12.05.2016 Decision :Deferred.

101

Case No.:309/5/82-

ALC4/2015
Party Name:SHREE VALLABH CHEMICAL Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00449/AM16/
RLA File :08/24/040/00417/AM15/
Lic.No/Date:0810134670 25.02.2015 Defer Date:12.05.2016

102

Case No.:273/5/82-

ALC4/2015
Party Name:BHARAT SERUMS & VACCINES LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00413/AM16/
RLA File :03/94/040/01055/AM15/
Lic.No/Date:0310794262 27.02.2015 Defer Date:12.05.2016 Decision : The Committee decided to defer the case for want of comments of DBT.

103 Case No.:452/5/82- ALC4/2015
Party Name:BLUE CIRCLE ORGANICS Meet No/Date:1/82- ALC4/2016 Status:Case Deferred

PVT. LTD. 07.04.2016 HQ File :01/82/050/00592/AM16/
RLA File :03/94/040/01091/AM15/
Lic.No/Date:0310794261 27.02.2015 Defer Date:12.05.2016

104

Case No.:295/5/82-

ALC4/2015
Party Name:PROLIFE INDUSTRIES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00435/AM16/
RLA File :08/24/040/00395/AM15/
Lic.No/Date:0810134703 03.03.2015 Defer Date:12.05.2016

105

Case No.:451/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/00591/AM16/
RLA File :03/94/040/01097/AM15/
Lic.No/Date:0310794354 04.03.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/371/2015-PI(Norms) dated 15.03.2016 ,

106

Case No.:303/5/82-

ALC4/2015
Party Name:ASSOCIATED DYESTUFF PVT. LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00443/AM16/
RLA File :08/24/040/00422/AM15/
Lic.No/Date:0810134739 05.03.2015 Defer Date:12.05.2016 Decision :Deferred.

107

Case No.:300/5/82-

ALC4/2015
Party Name:ADVANCE PETROCHEMICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00440/AM16/
RLA File :08/24/040/00448/AM15/
Lic.No/Date:0810134768 11.03.2015 Defer Date:12.05.2016 Decision :Deferred.

108

Case No.:450/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/00590/AM16/
RLA File :03/94/040/01114/AM15/
Lic.No/Date:0310794517 11.03.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/371/2015-PI(Norms) dated 16.03.2016 ,

109

Case No.:447/5/82-

ALC4/2015
Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00587/AM16/
RLA File :03/94/040/01131/AM15/
Lic.No/Date:0310794543 12.03.2015 Defer Date:12.05.2016 Decision :Deferred.

110

Case No.:409/5/82-

ALC4/2015
Party Name:NOCIL LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/00549/AM16/
RLA File :03/95/040/00974/AM15/
Lic.No/Date:0310794587 16.03.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/32/2012-Ch-II dated 4.03.2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

111

Case No.:45/4/82-

ALC4/2015
Party Name:TIDE INDUSTRIES Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00084/AM16/
RLA File :34/24/040/00325/AM15/
Lic.No/Date:3410041050 16.03.2015 Defer Date:12.05.2016 Decision :Deferred.

112

Case No.:6/8/82-ALC4/2015 Party Name:YELURI

FORMULATIONS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/00802/AM16/
RLA File :09/24/040/00690/AM15/
Lic.No/Date:0910061710 16.03.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/645/2015-PI(Norms) dated 21.3.2016, uploaded

113

Case No.:291/5/82-

ALC4/2015
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00431/AM16/
RLA File :05/23/040/00544/AM15/
Lic.No/Date:0510393616 18.03.2015 Defer Date:12.05.2016 Decision :Deferred.

114

Case No.:407/5/82-

ALC4/2015
Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00547/AM16/
RLA File :03/95/040/00934/AM15/
Lic.No/Date:0310794735 20.03.2015 Defer Date:12.05.2016 Decision :Committee deferred the case for want of comments of DOP.

115 Case No.:183/5/82- ALC4/2015
Party Name:SPAK ORGOCHEM (INDIA) Meet No/Date:1/82- ALC4/2016 Status:Case Deferred

PVT. LTD. 07.04.2016 HQ File :01/82/050/00323/AM16/
RLA File :03/95/040/00964/AM15/
Lic.No/Date:0310794811 23.03.2015 Defer Date:12.05.2016 Decision :Deferred.

116

Case No.:29/5/82-

ALC4/2015
Party Name:ASSOCIATED DYESTUFF PVT. LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00169/AM16/
RLA File :08/24/040/00483/AM15/
Lic.No/Date:0810134917 25.03.2015 Defer Date:12.05.2016 Decision :Deferred.

117

Case No.:427/5/82-

ALC4/2015
Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00567/AM16/
RLA File :03/95/040/01071/AM15/
Lic.No/Date:0310794916 26.03.2015 Defer Date:12.05.2016 deferred the case.

118

Case No.:431/5/82-

ALC4/2015
Party Name:EUROLIFE HEALTHCARE PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00571/AM16/
RLA File :03/94/040/01086/AM15/
Lic.No/Date:0310794964 27.03.2015 Defer Date:12.05.2016 deferred the case.

119

Case No.:16/5/82-

ALC4/2015
Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00156/AM16/
RLA File :09/24/040/00736/AM15/
Lic.No/Date:0910061856 31.03.2015 Defer Date:12.05.2016 deferred the case.

120

Case No.:405/5/82-

ALC4/2015
Party Name:CTX LIFESCIENCES PVT LTD, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/00545/AM16/
RLA File :03/94/040/00521/AM15/
Lic.No/Date:0310795052 31.03.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/413/2015-PI(Norms) dated 22.03.2016 ,

121 Case No.:28/5/82- Party Name:RUCHI SOYA Meet No/Date:1/82- Status:Case

ALC4/2015
INDUSTRIES LTD ALC4/2016 07.04.2016 Approved HQ File :01/82/050/00168/AM16/
RLA File :56/24/040/00064/AM15/
Lic.No/Date:5610004573 31.03.2015 Defer Date: Decision: The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.14010/31/2015-CH-II dated 04.03.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP

122

Case No.:26/5/82-

ALC4/2015
Party Name:CONTINENTAL CHEMICALS Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00166/AM16/
RLA File :08/24/040/00470/AM15/
Lic.No/Date:0810134992 07.04.2015 Defer Date:12.05.2016 Decision :Deferred.

123

Case No.:411/5/82-

ALC4/2015
Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00551/AM16/
RLA File :03/95/040/01033/AM15/
Lic.No/Date:0310795186 08.04.2015 Defer Date:12.05.2016 deferred the case.

124

Case No.:5/5/82-

ALC4/2015
Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00145/AM16/
RLA File :08/24/040/00003/AM16/
Lic.No/Date:0810135051 17.04.2015 Defer Date:12.05.2016 deferred the case.

125

Case No.:35/5/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00175/AM16/
RLA File :09/24/040/00739/AM15/
Lic.No/Date:0910061891 17.04.2015 Defer Date:12.05.2016 Decision :Committee decided to sent a copy of application to DOP.

126

Case No.:132/7/82-

ALC4/2015
Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00737/AM16/
RLA File :03/94/040/00024/AM16/
Lic.No/Date:0310795429 20.04.2015 Defer Date:12.05.2016 Decision : The Committee based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/617/2015-PI(Norms) dated 21.03.2016 , uploaded at the end of these minutes decided to call for information from the firm.

127

Case No.:153/7/82-

ALC4/2015
Party Name:DR. ACHARYA LABORATORIES PVT. LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00758/AM16/
RLA File :03/94/040/00039/AM16/
Lic.No/Date:0310795534 24.04.2015 Defer Date:12.05.2016 Decision :Deferred.

128

Case No.:29/7/82-

ALC4/2015
Party Name:NUTRA SPECIALITIES PVT. LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00634/AM16/
RLA File :04/24/040/00003/AM16/
Lic.No/Date:0410160438 24.04.2015 Defer Date:12.05.2016 deferred the case.

129

Case No.:40/8/82-

ALC4/2015
Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00836/AM16/
RLA File :09/24/040/00042/AM16/
Lic.No/Date:0910061937 27.04.2015 Defer Date:12.05.2016 Decision :Deferred.

130

Case No.:174/5/82-

ALC4/2015
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00314/AM16/
RLA File :07/24/040/00393/AM15/
Lic.No/Date:0710108142 01.05.2015 Defer Date:12.05.2016 Decision :Deferred.

131

Case No.:176/5/82-

ALC4/2015
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00316/AM16/
RLA File :07/24/040/00389/AM15/
Lic.No/Date:0710108141 01.05.2015 Defer Date:12.05.2016

132

Case No.:177/5/82-

ALC4/2015
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00317/AM16/
RLA File :07/24/040/00390/AM15/
Lic.No/Date:0710108143 01.05.2015 Defer Date:12.05.2016

133

Case No.:62/8/82-

ALC4/2015
Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00858/AM16/
RLA File :09/24/040/00028/AM16/
Lic.No/Date:0910061955 01.05.2015 Defer Date:12.05.2016

deferred the case.

134

Case No.:111/7/82-

ALC4/2015
Party Name:ZIM LABORATORIES LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00716/AM16/
RLA File :03/95/040/00058/AM16/
Lic.No/Date:0310795699 05.05.2015 Defer Date:12.05.2016 deferred the case

135

Case No.:75/8/82-

ALC4/2015
Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00871/AM16/
RLA File :09/24/040/00051/AM16/
Lic.No/Date:0910061986 06.05.2015 Defer Date:12.05.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals forwarded vide O.M.No.35011/660/2015-PI(Norms) dated 12.2.2016, uploaded at the end of these minutes decided to call for COA of import and export items from foreign supplier to show that some activity is involved. The Committee accordingly decided to defer the case.

136

Case No.:65/8/82-

ALC4/2015
Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00861/AM16/
RLA File :09/24/040/00052/AM16/
Lic.No/Date:0910061973 06.05.2015 Defer Date:12.05.2016 deferred the case.

137

Case No.:7/5/82-

ALC4/2015
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00147/AM16/
RLA File :05/23/040/00037/AM16/
Lic.No/Date:0510394177 08.05.2015 Defer Date:12.05.2016 deferred the case.

138

Case No.:38/8/82-

ALC4/2015
Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00834/AM16/
RLA File :09/24/040/00060/AM16/
Lic.No/Date:0910061998 08.05.2015 Defer Date:12.05.2016 deferred the case.

139 Case No.:42/8/82- ALC4/2015
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:1/82- ALC4/2016 Status:Case Approved

07.04.2016 HQ File :01/82/050/00838/AM16/
RLA File :09/24/040/00097/AM16/
Lic.No/Date:0910062057 21.05.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/682/2015-PI(Norms) dated 22.03.2016 ,

140

Case No.:200/5/82-

ALC4/2015
Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00340/AM16/
RLA File :04/24/040/00038/AM16/
Lic.No/Date:0410160569 21.05.2015 Defer Date:12.05.2016 deferred the case.

141

Case No.:97/8/82-

ALC4/2015
Party Name:ASCENT FINECHEM PVT. LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00893/AM16/
RLA File :08/24/040/00051/AM16/
Lic.No/Date:0810135338 22.05.2015 Defer Date:12.05.2016 Decision :Deferred .

142

Case No.:45/8/82-

ALC4/2015
Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00841/AM16/
RLA File :05/24/040/00073/AM16/
Lic.No/Date:0510394342 25.05.2015 Defer Date:12.05.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals forwarded vide O.M.No.35011/657/2015-PI(Norms) dated 12.2.2016, uploaded at the end of these minutes decided to call for information from the firm and deferred the case.

143

Case No.:86/8/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00882/AM16/
RLA File :09/24/040/00131/AM16/
Lic.No/Date:0910062091 29.05.2015 Defer Date:12.05.2016 Decision :Deferred.

144

Case No.:90/8/82-

ALC4/2015
Party Name:UNITED BIOTECH PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/00886/AM16/
RLA File :05/24/040/00072/AM16/
Lic.No/Date:0510394446 04.06.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.14010/679/2015-CH-II dated 21.03.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP

145

Case No.:187/7/82-

ALC4/2015
Party Name:ATUL LIMITED, Meet No/Date:1/82- ALC4/2016 07.04.2016 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:12.05.2016 Decision :Deferred.

14 6

Case No.:47/14/82-

ALC4/2015
Party Name:SMILAX LABORATORIES LIMI TED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Cas e Approved HQ File :01/82/050/01183/AM 16/
RLA File :09/24/040/00155/AM16/
Lic.No/Date:09100621 67 11.06.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/267/2015-PI(Norms) dated Oct. 2015 , uploaded

147

Case No.:121/8/82-

ALC4/2015
Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00917/AM16/
RLA File :03/95/040/00190/AM16/
Lic.No/Date:0310796766 23.06.2015 Defer Date:12.05.2016 Decision :Deferred.

148

Case No.:128/16/82-

ALC4/2015
Party Name:FLAGSHIP BIOTECH INTERNATIONAL PVT. LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01448/AM16/
RLA File :03/94/040/00217/AM16/
Lic.No/Date:0310796903 26.06.2015 Defer Date:12.05.2016

149

Case No.:89/7/82-

ALC4/2015
Party Name:HALDIA PETROCHEMICALS LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 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:12.05.2016 Decision :Deferred.

150

Case No.:77/7/82-

ALC4/2015
Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/00682/AM16/
RLA File :05/24/040/00130/AM16/
Lic.No/Date:0510394732 26.06.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/520/2015-PI(Norms) dated 18.01.2016,

151

Case No.:5/6/82-

ALC4/2015
Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00601/AM16/
RLA File :34/24/040/00091/AM16/
Lic.No/Date:3410041336 01.07.2015 Defer Date:12.05.2016 Decision :Deferred.

152

Case No.:109/8/82-

ALC4/2015
Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00905/AM16/
RLA File :03/95/040/00038/AM16/
Lic.No/Date:0310796997 01.07.2015 Defer Date:12.05.2016 deferred the case.

153

Case No.:97/14/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01233/AM16/
RLA File :09/24/040/00186/AM16/
Lic.No/Date:0910062271 01.07.2015 Defer Date:12.05.2016 Decision :Deferred.

154

Case No.:109/14/82-

ALC4/2015
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01245/AM16/
RLA File :09/24/040/00195/AM16/
Lic.No/Date:0910062283 02.07.2015 Defer Date:12.05.2016

155

Case No.:7/18/82-

ALC4/2015
Party Name:SHODHANA LABORATORIES LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01472/AM16/
RLA File :09/24/040/00198/AM16/
Lic.No/Date:0910062275 02.07.2015 Defer Date:12.05.2016

156

Case No.:28/1/82-

ALC1/2016
Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01802/AM16/
RLA File :07/24/040/00092/AM16/
Lic.No/Date:0710108460 03.07.2015 Defer Date:12.05.2016

157

Case No.:105/14/82-

ALC4/2015
Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred

HQ File :01/82/050/01241/AM16/
RLA File :09/24/040/00191/AM16/
Lic.No/Date:0910062299 03.07.2015 Defer Date:12.05.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals forwarded vide O.M.No.35011/660/2015-PI(Norms) dated 12.2.2016, uploaded at the end of these minutes decided to call for COA of import and export items from foreign to show that some activity is involved. The Committee accordingly decided to defer the case.

158

Case No.:28/14/82-

ALC4/2015
Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01164/AM16/
RLA File :05/24/040/00153/AM16/
Lic.No/Date:0510394804 06.07.2015 Defer Date:

159

Case No.:104/14/82-

ALC4/2015
Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01240/AM16/
RLA File :09/24/040/00701/AM15/
Lic.No/Date:0910062324 09.07.2015 Defer Date:12.05.2016

160

Case No.:54/8/82-

ALC4/2015
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00850/AM16/
RLA File :05/23/040/00150/AM16/
Lic.No/Date:0510394862 09.07.2015 Defer Date:12.05.2016 Decision : The Committee based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/662/2015-PI(Norms) dated 21.03.2016 , uploaded at the end of these minutes decided to call for information from the firm and deferred the case.

161

Case No.:50/8/82-

ALC4/2015
Party Name:PUSILIN BIOTECHNOLOGY PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00846/AM16/
RLA File :06/24/040/00014/AM16/
Lic.No/Date:0610038189 09.07.2015 Defer Date:12.05.2016

162

Case No.:51/14/82-

ALC4/2015
Party Name:SRIAM LABS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01187/AM16/
RLA File :09/24/040/00197/AM16/
Lic.No/Date:0910062326 13.07.2015 Defer Date:12.05.2016

163

Case No.:54/14/82-

ALC4/2015
Party Name:BIOLOGICAL E LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01190/AM16/
RLA File :09/24/040/00524/AM15/
Lic.No/Date:0910062332 15.07.2015 Defer Date:12.05.2016

Decision : The Committee decided to defer the case for want of comments of DBT.

164

Case No.:59/14/82-

ALC4/2015
Party Name:BIOLOGICAL E LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01195/AM16/
RLA File :09/24/040/00525/AM15/
Lic.No/Date:0910062331 15.07.2015 Defer Date:12.05.2016 Decision : The Committee decided to defer the case for want of comments of DBT.

165

Case No.:41/14/82-

ALC4/2015
Party Name:DEEPAK NITRITE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01177/AM16/
RLA File :34/24/040/00031/AM16/
Lic.No/Date:3410041376 15.07.2015 Defer Date:12.05.2016 Decision :Deferred.

166

Case No.:20/16/82-

ALC4/2015
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01340/AM16/
RLA File :09/24/040/00032/AM16/
Lic.No/Date:0910062338 15.07.2015 Defer Date:12.04.2016

167

Case No.:113/8/82-

ALC4/2015
Party Name:UNIJULES LIFE SCIENCES LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/00909/AM16/
RLA File :03/95/040/00299/AM16/
Lic.No/Date:0310797251 15.07.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/225/2015-PI(Norms) dated 15.3.2016 ,

168

Case No.:70/8/82-

ALC4/2015
Party Name:ZEISS PHARMACEUTICALS PVT.LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/00866/AM16/
RLA File :22/24/040/00024/AM16/
Lic.No/Date:2210015267 15.07.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/665/2015-PI(Norms) dated 21.3.2016 ,

169

Case No.:49/8/82-

ALC4/2015
Party Name:M.L.A. INDUSTRIES Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00845/AM16/
RLA File :06/24/040/00015/AM16/
Lic.No/Date:0610038193 16.07.2015 Defer Date:12.05.2016 deferred the case.

170

Case No.:120/8/82-

ALC4/2015
Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00916/AM16/
RLA File :03/95/040/00304/AM16/
Lic.No/Date:0310797293 16.07.2015 Defer Date:12.05.2016 deferred the case.

171

Case No.:55/8/82-

ALC4/2015
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/00851/AM16/
RLA File :05/23/040/00142/AM16/
Lic.No/Date:0510394969 17.07.2015 Defer Date: Decision : The Committee based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/667/2015-PI(Norms) dated 21.03.2016, uploaded at the end of these minutes decided to ratify norms on net to net basis. The quantity of import item allowed 0.50kg for 1kg of export product under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

172

Case No.:49/14/82-

ALC4/2015
Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01185/AM16/
RLA File :09/24/040/00205/AM16/
Lic.No/Date:0910062344 17.07.2015 Defer Date:12.05.2016 Decision :Deferred.

173

Case No.:39/14/82-

ALC4/2015
Party Name:JAGSONPAL PHARMACEUTICALS LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01175/AM16/
RLA File :05/23/040/00165/AM16/
Lic.No/Date:0510395004 20.07.2015 Defer Date:12.05.2016 Decision : The Committee based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/659/2015-PI(Norms) dated 21.03.2016 , uploaded at the end of these minutes decided to call for information from the firm.

174

Case No.:42/14/82-

ALC4/2015
Party Name:MEDICAMEN ORGANICS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01178/AM16/
RLA File :05/24/040/00193/AM16/
Lic.No/Date:0510395021 21.07.2015 Defer Date:12.05.2016

175

Case No.:112/14/82-

ALC4/2015
SCIENCES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01248/AM16/
RLA File :09/24/040/00221/AM16/
Lic.No/Date:0910062348 21.07.2015 Defer Date:12.05.2016

176

Case No.:21/16/82-

ALC4/2015
Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01341/AM16/
RLA File :09/24/040/00223/AM16/
Lic.No/Date:0910062361 22.07.2015 Defer Date:12.05.2016

177

Case No.:22/16/82-

ALC4/2015
Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01342/AM16/
RLA File :09/24/040/00224/AM16/
Lic.No/Date:0910062360 22.07.2015 Defer Date:12.05.2016

178

Case No.:50/14/82-

ALC4/2015
Party Name:SRIAM LABS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01186/AM16/
RLA File :09/24/040/00226/AM16/
Lic.No/Date:0910062363 23.07.2015 Defer Date:12.05.2016

179

Case No.:149/14/82-

ALC4/2015
Party Name:VISION DRUGS PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01285/AM16/
RLA File :09/24/040/00230/AM16/
Lic.No/Date:0910062365 23.07.2015 Defer Date:12.05.2016 deferred the case.

180

Case No.:79/8/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00875/AM16/
RLA File :05/24/040/00110/AM16/
Lic.No/Date:0510395084 24.07.2015 Defer Date:12.05.2016

181

Case No.:1/10/82-

ALC4/2015
Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00957/AM16/
RLA File :09/24/040/00211/AM16/
Lic.No/Date:0910062393 28.07.2015 Defer Date:12.05.2016 Decision :Deferred.

182

Case No.:170/14/82-

ALC4/2015
Party Name:PI INDUSTRIES LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred

HQ File :01/82/050/01306/AM16/
RLA File :13/24/040/00015/AM16/
Lic.No/Date:1310047932 29.07.2015 Defer Date:12.05.2016 Decision :Deferred.

183

Case No.:131/14/82-

ALC4/2015
Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01267/AM16/
RLA File :09/24/040/00212/AM16/
Lic.No/Date:0910062413 30.07.2015 Defer Date:12.05.2016 Decision :Deferred.

184

Case No.:60/14/82-

ALC4/2015
Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01196/AM16/
RLA File :09/24/040/00256/AM16/
Lic.No/Date:0910062418 31.07.2015 Defer Date:12.05.2016 Decision :Committee decided to defer the case for want of comments of DOP.

185

Case No.:84/1/82-

ALC1/2016
Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01858/AM16/
RLA File :08/91/040/00210/AM16/
Lic.No/Date:0810135770 03.08.2015 Defer Date:12.05.2016 Decision : Committee decided to defer the case for want of comments of DOP.

186

Case No.:169/14/82-

ALC4/2015
Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01305/AM16/
RLA File :31/83/040/00018/AM16/
Lic.No/Date:3110065573 03.08.2015 Defer Date:12.05.2016 Decision :Deferred.

187

Case No.:17/8/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00813/AM16/
RLA File :09/24/040/00251/AM16/
Lic.No/Date:0910062426 03.08.2015 Defer Date:12.05.2016 Decision :Deferred

188

Case No.:168/14/82-

ALC4/2015
Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01304/AM16/
RLA File :31/83/040/00024/AM16/
Lic.No/Date:3110065579 04.08.2015 Defer Date:12.05.2016 Decision :Deferred

189

Case No.:13/18/82-

ALC4/2015
Party Name:FINE ORGANIC INDUSTRIES PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred

HQ File :01/82/050/01478/AM16/
RLA File :03/94/040/00334/AM16/
Lic.No/Date:0310797973 05.08.2015 Defer Date:12.05.2016 Decision :Deferred

190

Case No.:12/18/82-

ALC4/2015
Party Name:OMTECH CHEMICAL INDUSTRIES PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01477/AM16/
RLA File :03/95/040/00345/AM16/
Lic.No/Date:0310797967 05.08.2015 Defer Date:12.05.2016 Decision : Deferred

191

Case No.:14/14/82-

ALC4/2015
Party Name:ZIM LABORATORIES LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01150/AM16/
RLA File :03/95/040/00356/AM16/
Lic.No/Date:0310798008 07.08.2015 Defer Date:12.05.2016 Decision : The Committee based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/511/2015-PI(Norms) dated 30.12.2015 , uploaded at the end of these minutes decided to call for information from the firm and deferred the case.

192

Case No.:18/14/82-

ALC4/2015
Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01154/AM16/
RLA File :03/95/040/00317/AM16/
Lic.No/Date:0310798039 10.08.2015 Defer Date:12.05.2016 Decision :Deferred.

193

Case No.:115/16/82-

ALC4/2015
Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01435/AM16/
RLA File :03/95/040/00164/AM16/
Lic.No/Date:0310798051 10.08.2015 Defer Date:12.05.2016

194

Case No.:23/8/82-

ALC4/2015
Party Name:ALPHAMED FORMULATIONS P LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00819/AM16/
RLA File :09/24/040/00091/AM16/
Lic.No/Date:0910062478 11.08.2015 Defer Date:12.05.2016 Decision : The Committee based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/690/2015-PI(Norms) dated 21.3.2016 , uploaded at the end of these minutes decided to call for information from the firm and deferred the case.

195

Case No.:22/8/82-

ALC4/2015
Party Name:GRANULES INDIA LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File RLA File Lic.No/Date:0910062467 Defer Date:

:01/82/050/00818/AM16/
:09/24/040/00287/AM16/
11.08.2015 Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/166/2013-PI(Norms) dated 09.05.2013 ,

196

Case No.:155/14/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01291/AM16/
RLA File :05/24/040/00237/AM16/
Lic.No/Date:0510395271 11.08.2015 Defer Date:12.05.2016

197

Case No.:160/14/82-

ALC4/2015
SCIENCES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01296/AM16/
RLA File :09/24/040/00286/AM16/
Lic.No/Date:0910062483 12.08.2015 Defer Date:12.05.2016

198

Case No.:11/18/82-

ALC4/2015
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01476/AM16/
RLA File :03/95/040/00327/AM16/
Lic.No/Date:0310798117 13.08.2015 Defer Date:12.05.2016 Decision :Deferred

199

Case No.:133/14/82-

ALC4/2015
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01269/AM16/
RLA File :09/24/040/00298/AM16/
Lic.No/Date:0910062500 14.08.2015 Defer Date:12.05.2016

200

Case No.:34/14/82-

ALC4/2015
Party Name:TRANSPEK INDUSTRY LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01170/AM16/
RLA File :34/24/040/00144/AM16/
Lic.No/Date:3410041464 17.08.2015 Defer Date:12.05.2016

201

Case No.:96/14/82-

ALC4/2015
Party Name:MAITHRI LABORATORIES (P) LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01232/AM16/
RLA File :09/24/040/00293/AM16/
Lic.No/Date:0910062511 18.08.2015 Defer Date:12.05.2016

202 Case No.:99/14/82- ALC4/2015
Party Name:OPTIMUS DRUGS PRIVATE Meet No/Date:1/82- ALC4/2016 Status:Case Deferred

LIMITED 07.04.2016 HQ File :01/82/050/01235/AM16/
RLA File :09/24/040/00231/AM16/
Lic.No/Date:0910062516 18.08.2015 Defer Date:12.05.2016 No.20 dated 09.03.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case.

203

Case No.:56/13/82-

ALC4/2015
Party Name:PANACEA BIOTEC LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01019/AM16/
RLA File :05/24/040/00183/AM16/
Lic.No/Date:0510395354 18.08.2015 Defer Date:12.05.2016 Decision :Deferred for want of comment of DBT.

204

Case No.:154/14/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01290/AM16/
RLA File :05/24/040/00381/AM15/
Lic.No/Date:0510395357 19.08.2015 Defer Date:12.05.2016 Decision :Deferred

205

Case No.:68/14/82-

ALC4/2015
Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01204/AM16/
RLA File :09/24/040/00368/AM15/
Lic.No/Date:0910062518 19.08.2015 Defer Date:12.05.2016 Decision :Deferred

206

Case No.:30/14/82-

ALC4/2015
Party Name:BHARAT PARENTERALS LTD, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01166/AM16/
RLA File :34/24/040/00143/AM16/
Lic.No/Date:3410041467 20.08.2015 Defer Date:12.05.2016

207

Case No.:6/14/82-

ALC4/2015
Party Name:PREGNA INTERNATIONAL LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01142/AM16/
RLA File :03/95/040/00364/AM16/
Lic.No/Date:0310798287 20.08.2015 Defer Date: Decision : The Committee based on the recommendation of D/o Chemicals and Petrochemicals forwarded vide O.M. No.46011/22/2008-PC.II dated 05.04.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

208

Case No.:66/14/82-

ALC4/2015
Party Name:SRIAM LABS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01202/AM16/
RLA File :09/24/040/00290/AM16/
Lic.No/Date:0910062526 21.08.2015 Defer Date:12.05.2016

209

Case No.:23/14/82-

ALC4/2015
Party Name:RUSAN PHARMA LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01159/AM16/
RLA File :03/95/040/00400/AM16/
Lic.No/Date:0310798441 25.08.2015 Defer Date:12.05.2016

210

Case No.:3/14/82-

ALC4/2015
Party Name:SHIRDI CHEMICALS PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01139/AM16/
RLA File :03/95/040/00401/AM16/
Lic.No/Date:0310798433 25.08.2015 Defer Date:12.05.2016 Decision :Deferred.

211

Case No.:24/14/82-

ALC4/2015
Party Name:SHUBHAM SPECIALTY PRODUCTS Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01160/AM16/
RLA File :03/95/040/00348/AM16/
Lic.No/Date:0310798516 27.08.2015 Defer Date:12.05.2016 Decision :Deferred.

212

Case No.:35/14/82-

ALC4/2015
Party Name:VENUS REMEDIES LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01171/AM16/
RLA File :22/24/040/00032/AM16/
Lic.No/Date:2210015295 27.08.2015 Defer Date:12.05.2016

213

Case No.: 36/14/82-

ALC4/2015
Party Name:VENUS REMEDIES LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved
HQ File :01/82/050/01172/AM16/
RLA File :22/24/040/00034/AM16/
Lic.No/Date:2210015294 27.08.2015 Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/317/2015-PI(Norms) dated November 2015,

214

Case No.:133/8/82-

ALC4/2015
Party Name:AKTINOS HEALTHCARE PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/00929/AM16/
RLA File :09/24/040/00227/AM16/
Lic.No/Date:0910062545 28.08.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/688/2015-PI(Norms) dated 29.03.2016,

215

Case No.:82/14/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01218/AM16/
RLA File :05/24/040/00233/AM16/
Lic.No/Date:0510395480 31.08.2015 Defer Date:12.05.2016 Decision :Deferred.

216

Case No.:89/14/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01225/AM16/
RLA File :05/24/040/00224/AM16/
Lic.No/Date:0510395479 31.08.2015 Defer Date:12.05.2016 Decision :Deferred.

217

Case No.:94/14/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01230/AM16/
RLA File :05/24/040/00202/AM16/
Lic.No/Date:0510395481 31.08.2015 Defer Date:12.05.2016 Decision :Deferred.

218

Case No.:116/16/82-

ALC4/2015
Party Name:PANERA BIOTEC PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01436/AM16/
RLA File :05/24/040/00181/AM16/
Lic.No/Date:0510395496 01.09.2015 Defer Date:12.05.2016 Decision : The Committee decided to defer the case for want of comments of DBT.

219

Case No.:93/14/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01229/AM16/
RLA File :05/24/040/00244/AM16/
Lic.No/Date:0510395493 01.09.2015 Defer Date:12.05.2016

22 0

Case No.:57/14/82-

ALC4/2015
Party Name:SMILAX LABORATORIES LIMI TED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Cas e Approved HQ File :01/82/050/01193/AM 16/
RLA File :09/24/040/00322/AM16/
Lic.No/Date:09100625 47 03.09.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/267/2015-PI(Norms) dated Oct. 2015 , uploaded

221

Case No.:5/18/82-

ALC4/2015
Party Name:AMI ORGANICS PVT LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01470/AM16/
RLA File :52/24/040/00039/AM16/
Lic.No/Date:5210041625 04.09.2015 Defer Date:12.05.2016 Decision :Deferred.

222

Case No.:141/14/82-

ALC4/2015
Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01277/AM16/
RLA File :17/24/040/00050/AM16/
Lic.No/Date:1710006170 04.09.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/78/2012-Ch-II dated 04.03.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

223

Case No.:125/16/82-

ALC4/2015
Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01445/AM16/
RLA File :03/94/040/00171/AM16/
Lic.No/Date:0310798674 04.09.2015 Defer Date:12.05.2016

224

Case No.:52/14/82-

ALC4/2015
Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01188/AM16/
RLA File :09/24/040/00323/AM16/
Lic.No/Date:0910062554 04.09.2015 Defer Date:12.05.2016

225

Case No.:10/20/82-

ALC4/2015
Party Name:U SQUARE LIFESCIENCE PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01593/AM16/
RLA File :08/24/040/00153/AM16/
Lic.No/Date:0810135975 04.09.2015 Defer Date:12.05.2016

226

Case No.:119/16/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01439/AM16/
RLA File :03/94/040/00402/AM16/
Lic.No/Date:0310798725 08.09.2015 Defer Date: 12.05.2016

227

Case No.:120/16/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred

HQ File :01/82/050/01440/AM16/
RLA File :03/94/040/00403/AM16/
Lic.No/Date:0310798726 08.09.2015 Defer Date: 12.05.2016

228

Case No.:121/16/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01441/AM16/
RLA File :03/94/040/00405/AM16/
Lic.No/Date:0310798727 08.09.2015 Defer Date: 12.05.2016

229

Case No.:56/14/82-

ALC4/2015
Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01192/AM16/
RLA File :09/24/040/00134/AM16/
Lic.No/Date:0910062560 08.09.2015 Defer Date:12.05.2016 Decision :Deferred.

230

Case No.:124/16/82-

ALC4/2015
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01444/AM16/
RLA File :03/94/040/00399/AM16/
Lic.No/Date:0310798771 09.09.2015 Defer Date:12.05.2016 Decision :Deferred.

231

Case No.:46/14/82-

ALC4/2015
Party Name:MALWA OXYGEN & INDUSTRIAL GASES PVT.LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01182/AM16/
RLA File :56/24/040/00005/AM16/
Lic.No/Date:5610004674 09.09.2015 Defer Date:12.05.2016 Decision :Deferred.

232

Case No.:53/14/82-

ALC4/2015
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01189/AM16/
RLA File :09/24/040/00315/AM16/
Lic.No/Date:0910062581 09.09.2015 Defer Date:12.05.2016 Decision : : The Committee decided to defer the case for want of comments of DoP.

233

Case No.:157/14/82-

ALC4/2015
Party Name:AETHER INDUSTRIES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01293/AM16/
RLA File :52/24/040/00042/AM16/
Lic.No/Date:5210041630 10.09.2015 Defer Date:12.05.2016 Decision :Deferred.

234 Case No.:122/16/82- ALC4/2015
Party Name:KOPRAN RESEARCH Meet No/Date:1/82- ALC4/2016 Status:Case Deferred

LABORATORIES LTD. 07.04.2016 HQ File :01/82/050/01442/AM16/
RLA File :03/94/040/00462/AM16/
Lic.No/Date:0310798808 10.09.2015 Defer Date:12.05.2016 Decision : Deferred.

235

Case No.:123/16/82-

ALC4/2015
Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01443/AM16/
RLA File :03/94/040/00463/AM16/
Lic.No/Date:0310798809 10.09.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/724/2015-PI(Norms) dated 4.4.2016, uploaded

236

Case No.:125/14/82-

ALC4/2015
Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01261/AM16/
RLA File :09/24/040/00345/AM16/
Lic.No/Date:0910062589 10.09.2015 Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/175/2015-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

237

Case No.:78/14/82-

ALC4/2015
Party Name:AMI LIFESCIENCES P LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01214/AM16/
RLA File :34/24/040/00148/AM16/
Lic.No/Date:3410041505 11.09.2015 Defer Date:12.05.2016 Decision :Deferred.

238

Case No.:4/16/82-

ALC4/2015
Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01324/AM16/
RLA File :09/24/040/00297/AM16/
Lic.No/Date:0910062594 11.09.2015 Defer Date:12.05.2016

239

Case No.:9/16/82-

ALC4/2015
Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01329/AM16/
RLA File :09/24/040/00328/AM16/
Lic.No/Date:0910062593 11.09.2015 Defer Date:12.05.2016 Decision : The Committee decided to defer the case for want of comments of DoP..

240

Case No.:56/16/82-

ALC4/2015
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred

HQ File :01/82/050/01376/AM16/
RLA File :03/94/040/00435/AM16/
Lic.No/Date:0310798876 14.09.2015 Defer Date:12.05.2016 Decision :Deferred.

241

Case No.:59/16/82-

ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01379/AM16/
RLA File :03/94/040/00474/AM16/
Lic.No/Date:0310798877 14.09.2015 Defer Date:12.05.2016 Decision : : The Committee decided to send a copy of application to DOP.

242

Case No.:8/14/82-

ALC4/2015
Party Name:PRIVI ORGANICS LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01144/AM16/
RLA File :03/95/040/00343/AM16/
Lic.No/Date:0310798846 14.09.2015 Defer Date:12.05.2016 Decision :Deferred.

243

Case No.:110/14/82-

ALC4/2015
Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01246/AM16/
RLA File :09/24/040/00305/AM16/
Lic.No/Date:0910062601 14.09.2015 Defer Date:12.05.2016 Decision :Deferred.

244

Case No.:134/14/82-

ALC4/2015
Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01270/AM16/
RLA File :09/24/040/00273/AM16/
Lic.No/Date:0910062602 14.09.2015 Defer Date:12.05.2016 Decision :Deferred.

245

Case No.:7/14/82-

ALC4/2015
Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01143/AM16/
RLA File :03/95/040/00426/AM16/
Lic.No/Date:0310798872 14.09.2015 Defer Date:12.05.2016 Decision : The Committee decided to call for copy of DML and Master Batch Formula from the firm and deferred the case.

246

Case No.:74/14/82-

ALC4/2015
Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01210/AM16/
RLA File :34/24/040/00120/AM16/
Lic.No/Date:3410041510 15.09.2015 Defer Date:12.05.2016 Decision :Deferred.

247 Case No.:15/14/82- Party Name:NEW Meet No/Date:1/82- Status:Case

ALC4/2015
ALLIANCE DYE-CHEM PVT. LTD., ALC4/2016 07.04.2016 Deferred HQ File :01/82/050/01151/AM16/
RLA File :03/95/040/00360/AM16/
Lic.No/Date:0310798909 15.09.2015 Defer Date:12.05.2016 Decision :Deferred.

248

Case No.:77/14/82-

ALC4/2015
Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01213/AM16/
RLA File :34/24/040/00164/AM16/
Lic.No/Date:3410041519 16.09.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/582/2015-PI(Norms) dated 10.03.2016,

249

Case No.:9/14/82-

ALC4/2015
Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01145/AM16/
RLA File :03/95/040/00434/AM16/
Lic.No/Date:0310798944 16.09.2015 Defer Date:12.05.2016 Decision :Deferred.

250

Case No.:98/14/82-

ALC4/2015
Party Name:SRINI PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01234/AM16/
RLA File :09/24/040/00333/AM16/
Lic.No/Date:0910062625 16.09.2015 Defer Date:12.05.2016

251

Case No.:124/14/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01260/AM16/
RLA File :09/24/040/00355/AM16/
Lic.No/Date:0910062622 16.09.2015 Defer Date:12.05.2016

252

Case No.:35/16/82-

ALC4/2015
Party Name:D. R. COATS INK & RESINS PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01355/AM16/
RLA File :03/94/040/00415/AM16/
Lic.No/Date:0310798977 21.09.2015 Defer Date:12.05.2016

253

Case No.:34/16/82-

ALC4/2015
Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01354/AM16/
RLA File :03/94/040/00472/AM16/
Lic.No/Date:0310798979 21.09.2015 Defer Date:12.05.2016

254

Case No.:71/14/82-

ALC4/2015
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01207/AM16/
RLA File :09/24/040/00376/AM16/
Lic.No/Date:0910062633 21.09.2015 Defer Date:12.05.2016

255

Case No.:64/14/82-

ALC4/2015
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01200/AM16/
RLA File :09/24/040/00375/AM16/
Lic.No/Date:0910062644 22.09.2015 Defer Date:12.05.2016 Decision : The Committee noted that information has been called for from the firm in NC meeting No.20 dt. 09.03.2016 and same is awaited. The Committee accordingly deferred the case.

256

Case No.:117/14/82-

ALC4/2015
Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01253/AM16/
RLA File :04/24/040/00140/AM16/
Lic.No/Date:0410161044 22.09.2015 Defer Date:12.05.2016 deferred the case.

257

Case No.:118/14/82-

ALC4/2015
Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01254/AM16/
RLA File :04/24/040/00139/AM16/
Lic.No/Date:0410161045 22.09.2015 Defer Date:12.05.2016 deferred the case.

258

Case No.:103/14/82-

ALC4/2015
Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01239/AM16/
RLA File :09/24/040/00362/AM16/
Lic.No/Date:0910062635 22.09.2015 Defer Date:12.05.2016 deferred the case

259

Case No.:25/20/82-

ALC4/2015
Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01608/AM16/
RLA File :13/24/040/00027/AM16/
Lic.No/Date:1310047981 23.09.2015 Defer Date:12.05.2016

260

Case No.:106/14/82-

ALC4/2015
SCIENCES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01242/AM16/
RLA File :09/24/040/00373/AM16/
Lic.No/Date:0910062649 23.09.2015 Defer Date:12.05.2016

261

Case No.:91/14/82-

ALC4/2015
Party Name:CURETECH SKINCARE Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01227/AM16/
RLA File :22/21/040/00029/AM16/
Lic.No/Date:2210015316 24.09.2015 Defer Date:12.05.2016

262

Case No.:5/20/82-

ALC4/2015
Party Name:DORF- KETAL CHEMICALS INDIA PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01588/AM16/
RLA File :03/94/040/00471/AM16/
Lic.No/Date:0310799047 24.09.2015 Defer Date:12.05.2016

263

Case No.:86/14/82-

ALC4/2015
Party Name:BELLAPREMIER HAPPY HYGIENECARE PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01222/AM16/
RLA File :35/24/040/00005/AM16/
Lic.No/Date:3510044794 25.09.2015 Defer Date:12.05.2016

264

Case No.:65/14/82-

ALC4/2015
Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01201/AM16/
RLA File :09/24/040/00291/AM16/
Lic.No/Date:0910062665 28.09.2015 Defer Date:12.05.2016 Decision : The Committee decided to send a copy of application to DOP.

265

Case No.:8/16/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01328/AM16/
RLA File :09/24/040/00294/AM16/
Lic.No/Date:0910062666 28.09.2015 Defer Date:12.05.2016 Decision :Deferred.

266

Case No.:68/16/82-

ALC4/2015
Party Name:ZIM LABORATORIES LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01388/AM16/
RLA File :03/95/040/00454/AM16/
Lic.No/Date:0310799077 28.09.2015 Defer Date:12.05.2016

267

Case No.:79/14/82-

ALC4/2015
Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01215/AM16/
RLA File :05/23/040/00274/AM16/
Lic.No/Date:0510395773 30.09.2015 Defer Date:12.05.2016 Decision : The Committee decided to defer the case for want of comments of AYUSH.

268

Case No.:6/10/82-

ALC4/2015
Party Name:ARCHIMEDIS LABORATORIES PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/00962/AM16/
RLA File :09/24/040/00321/AM16/
Lic.No/Date:0910062670 30.09.2015 Defer Date:12.05.2016

269

Case No.:69/16/82-

ALC4/2015
Party Name:PIDILITE INDUSTRIES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01389/AM16/
RLA File :03/95/040/00350/AM15/
Lic.No/Date:0310799113 30.09.2015 Defer Date:12.05.2016 Decision :Deferred.

270

Case No.:33/16/82-

ALC4/2015
Party Name:BLISS INDASI LIFESCIENCES PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01353/AM16/
RLA File :03/94/040/00483/AM16/
Lic.No/Date:0310799128 01.10.2015 Defer Date:12.05.2016

271

Case No.:55/16/82-

ALC4/2015
Party Name:DORF- KETAL CHEMICALS INDIA PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01375/AM16/
RLA File :03/94/040/00525/AM16/
Lic.No/Date:0310799188 05.10.2015 Defer Date:12.05.2016

272

Case No.:43/16/82-

ALC4/2015
Party Name:INDOFIL INDUSTRIES LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01363/AM16/
RLA File :03/94/040/00423/AM16/
Lic.No/Date:0310799184 05.10.2015 Defer Date:12.05.2016 Decision :Deferred.

273

Case No.:10/16/82-

ALC4/2015
Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred

HQ File :01/82/050/01330/AM16/
RLA File :09/24/040/00266/AM16/
Lic.No/Date:0910062673 05.10.2015 Defer Date:12.05.2016 Decision :Deferred.

274

Case No.:65/16/82-

ALC4/2015
Party Name:RELIANCE INDUSTRIES LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01385/AM16/
RLA File :03/95/040/00355/AM16/
Lic.No/Date:0310799215 06.10.2015 Defer Date: Chemicals and Petrochemicals forwarded vide O.M. No.46011/57/2009-PC-II dated 06.04.2016,

275

Case No.:67/16/82-

ALC4/2015
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01387/AM16/
RLA File :03/95/040/00485/AM16/
Lic.No/Date:0310799241 06.10.2015 Defer Date:12.05.2016 Decision :Deferred.

276

Case No.:6/16/82-

ALC4/2015
Party Name:HETERO DRUGS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01326/AM16/
RLA File :09/24/040/00404/AM16/
Lic.No/Date:0910062686 07.10.2015 Defer Date: 12.05.2016

277

Case No.:45/16/82-

ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01365/AM16/
RLA File :03/94/040/00529/AM16/
Lic.No/Date:0310799266 07.10.2015 Defer Date:12.05.2016

278

Case No.:25/16/82-

ALC4/2015
Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01345/AM16/
RLA File :09/24/040/00347/AM16/
Lic.No/Date:0910062681 07.10.2015 Defer Date:12.05.2016

279

Case No.:139/14/82-

ALC4/2015
Party Name:MAMTA POLYCOATS Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01275/AM16/
RLA File :34/24/040/00178/AM16/
Lic.No/Date:3410041581 08.10.2015 Defer Date:12.05.2016 Decision :Deferred.

280 Case No.:126/16/82- Party Name:NEW Meet No/Date:1/82- Status:Case

ALC4/2015
ALLIANCE DYE-CHEM PVT. LTD., ALC4/2016 07.04.2016 Deferred HQ File :01/82/050/01446/AM16/
RLA File :03/95/040/00445/AM16/
Lic.No/Date:0310799287 08.10.2015 Defer Date:12.05.2016 Decision :Deferred.

281

Case No.:61/16/82-

ALC4/2015
Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01381/AM16/
RLA File :03/95/040/00483/AM16/
Lic.No/Date:0310799284 08.10.2015 Defer Date:12.05.2016 Decision :The Committee noted that information has been called for from the firm in NC Meeting No.20 dated 09.03.2016 and reply is awaited. The Committee accordingly decided to defer the case.

282

Case No.:62/16/82-

ALC4/2015
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01382/AM16/
RLA File :03/95/040/00491/AM16/
Lic.No/Date:0310799292 08.10.2015 Defer Date:12.05.2016 Decision :Deferred.

283

Case No.:17/16/82-

ALC4/2015
Party Name:VISION DRUGS PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01337/AM16/
RLA File :09/24/040/00402/AM16/
Lic.No/Date:0910062693 08.10.2015 Defer Date:12.05.2016 Decision : The Committee noted that information has been called for from the firm in NC Meeting No.20 dated 09.03.2016 and reply is awaited. The Committee accordingly decided to defer the case.

284

Case No.:23/16/82-

ALC4/2015
Party Name:SHREEGEN PHARMA LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01343/AM16/
RLA File :09/24/040/00359/AM16/
Lic.No/Date:0910062695 09.10.2015 Defer Date:12.05.2016

285

Case No.:164/14/82-

ALC4/2015
Party Name:AASHA BIOCHEM Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01300/AM16/
RLA File :10/24/040/00049/AM16/
Lic.No/Date:1010059293 12.10.2015 Defer Date:12.05.2016

286

Case No.:82/16/82-

ALC4/2015
Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01402/AM16/
RLA File :22/24/040/00048/AM16/
Lic.No/Date:2210015329 12.10.2015 Defer Date:

Pharmaceuticals forwarded vide O.M. No.35011/735/2015-PI(Norms) dated 28.03.2016,

287

Case No.:38/16/82-

ALC4/2015
Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01358/AM16/
RLA File :03/94/040/00536/AM16/
Lic.No/Date:0310799342 12.10.2015 Defer Date:12.05.2016

288

Case No.:140/14/82-

ALC4/2015
Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01276/AM16/
RLA File :34/24/040/00175/AM16/
Lic.No/Date:3410041586 12.10.2015 Defer Date:12.05.2016 Decision :Deferred.

289

Case No.:144/14/82-

ALC4/2015
Party Name:AMI ORGANICS PVT LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01280/AM16/
RLA File :52/24/040/00049/AM16/
Lic.No/Date:5210041658 14.10.2015 Defer Date:12.05.2016 Decision :Deferred.

290

Case No.:58/16/82-

ALC4/2015
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01378/AM16/
RLA File :03/94/040/00497/AM16/
Lic.No/Date:0310799433 14.10.2015 Defer Date:12.05.2016

291

Case No.:132/14/82-

ALC4/2015
Party Name:RIDDHI PHARMA Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01268/AM16/
RLA File :34/24/040/00180/AM16/
Lic.No/Date:3410041592 14.10.2015 Defer Date:12.05.2016 Decision :Deferred.

292

Case No.:60/16/82-

ALC4/2015
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01380/AM16/
RLA File :03/94/040/00486/AM16/
Lic.No/Date:0310799460 15.10.2015 Defer Date:12.05.2016

293 Case No.:92/16/82- ALC4/2015
Party Name:TRANSPEK INDUSTRY LIMITED Meet No/Date:1/82- ALC4/2016 Status:Case Deferred

07.04.2016 HQ File :01/82/050/01412/AM16/
RLA File :34/24/040/00185/AM16/
Lic.No/Date:3410041600 15.10.2015 Defer Date:12.05.2016

294

Case No.:57/16/82-

ALC4/2015
Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01377/AM16/
RLA File :03/94/040/00470/AM16/
Lic.No/Date:0310799489 16.10.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/67/2011-Ch-II dated 04.03.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

295

Case No.:158/14/82-

ALC4/2015
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01294/AM16/
RLA File :05/23/040/00305/AM16/
Lic.No/Date:0510395945 16.10.2015 Defer Date:12.05.2016

296

Case No.:77/16/82-

ALC4/2015
Party Name:LACTOSE (INDIA) LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01397/AM16/
RLA File :03/95/040/00481/AM16/
Lic.No/Date:0310799561 20.10.2015 Defer Date:21.05.2016

297

Case No.:26/16/82-

ALC4/2015
Party Name:NEULAND LABORATORIES LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01346/AM16/
RLA File :09/24/040/00370/AM16/
Lic.No/Date:0910062746 20.10.2015 Defer Date:12.05.2016

298

Case No.:11/16/82-

ALC4/2015
Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01331/AM16/
RLA File :09/24/040/00425/AM16/
Lic.No/Date:0910062758 20.10.2015 Defer Date:12.05.2016

299

Case No.:156/14/82-

ALC4/2015
Party Name:SOFTGEL HEALTH CARE PVT. LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01292/AM16/
RLA File :04/24/040/00158/AM16/
Lic.No/Date:0410161133 20.10.2015 Defer Date:12.05.2016

300

Case No.:27/16/82-

ALC4/2015
SCIENCES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01347/AM16/
RLA File :09/24/040/00420/AM16/
Lic.No/Date:0910062753 20.10.2015 Defer Date:12.05.2016

301

Case No.:72/16/82-

ALC4/2015
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01392/AM16/
RLA File :03/95/040/00102/AM16/
Lic.No/Date:0310799579 21.10.2015 Defer Date:12.05.2016 Decision :Deferred.

302

Case No.:73/16/82-

ALC4/2015
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Approved HQ File :01/82/050/01393/AM16/
RLA File :03/95/040/00087/AM16/
Lic.No/Date:0310799578 21.10.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/64/2013-Ch-II dated 4.03.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

303

Case No.:29/16/82-

ALC4/2015
Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01349/AM16/
RLA File :09/24/040/00379/AM16/
Lic.No/Date:0910062768 23.10.2015 Defer Date:12.05.2016 Decision :Deferred.

304

Case No.:30/16/82-

ALC4/2015
Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01350/AM16/
RLA File :09/24/040/00383/AM16/
Lic.No/Date:0910062767 23.10.2015 Defer Date:12.05.2016 Decision :Deferred.

305

Case No.:129/16/82-

ALC4/2015
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01449/AM16/
RLA File :03/95/040/00505/AM16/
Lic.No/Date:0310799628 23.10.2015 Defer Date:12.05.2016 Decision :Deferred.

306 Case No.:161/14/82- ALC4/2015
Party Name:KAIRAV CHEMOFARBE Meet No/Date:1/82- ALC4/2016 Status:Case Deferred

INDUSTRIES LTD. 07.04.2016 HQ File :01/82/050/01297/AM16/
RLA File :03/94/040/01226/AM15/
Lic.No/Date:0310799680 26.10.2015 Defer Date:12.05.2016 Decision :Deferred.

307

Case No.:78/16/82-

ALC4/2015
Party Name:MOHINI ORGANICS PVT. LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01398/AM16/
RLA File :03/95/040/00777/AM15/
Lic.No/Date:0310799666 26.10.2015 Defer Date:12.05.2016 Decision :Deferred.

308

Case No.:53/20/82-

ALC4/2015
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01636/AM16/
RLA File :03/95/040/00529/AM16/
Lic.No/Date:0310799675 26.10.2015 Defer Date:12.05.2016 Decision :Deferred.

30 9

Case No.:93/16/82-

ALC4/2015
Party Name:JAINEX SPECIALITY CHEMICAL Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01413/AM 16/
RLA File :34/24/040/00196/AM16/
Lic.No/Date:3410041626 28.10.2015 Defer Date: 12.05.2016 Decision :Deferred.

310

Case No.:31/16/82-

ALC4/2015
Party Name:MSN LABORATORIES PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01351/AM16/
RLA File :09/24/040/00423/AM16/
Lic.No/Date:0910062790 28.10.2015 Defer Date:12.05.2016

311

Case No.:74/16/82-

ALC4/2015
Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01394/AM16/
RLA File :03/95/040/00518/AM16/
Lic.No/Date:0310799705 28.10.2015 Defer Date:12.05.2016 Decision :Deferred.

312

Case No.:86/16/82-

ALC4/2015
Party Name:SAURAV CHEMICALS LTD, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01406/AM16/
RLA File :22/24/040/00056/AM16/
Lic.No/Date:2210015337 28.10.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/709/2015-PI(Norms) dated 22.03.2016,

313

Case No.:75/16/82-

ALC4/2015
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01395/AM16/
RLA File :03/95/040/00525/AM16/
Lic.No/Date:0310799704 28.10.2015 Defer Date:12.05.2016 Decision :Deferred.

314

Case No.:9/20/82-

ALC4/2015
Party Name:U SQUARE LIFESCIENCE PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01592/AM16/
RLA File :08/24/040/00237/AM16/
Lic.No/Date:0810136380 28.10.2015 Defer Date:12.05.2016

315

Case No.:47/16/82-

ALC4/2015
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01367/AM16/
RLA File :03/95/040/00526/AM16/
Lic.No/Date:0310799853 29.10.2015 Defer Date:12.05.2016 Decision :Deferred.

316

Case No.:136/14/82-

ALC4/2015
Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01272/AM16/
RLA File :05/23/040/00293/AM16/
Lic.No/Date:0510396078 30.10.2015 Defer Date:12.05.2016 Decision :Deferred.

317

Case No.:48/16/82-

ALC4/2015
Party Name:O C SPECIALITIES PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01368/AM16/
RLA File :03/95/040/00549/AM16/
Lic.No/Date:0310799873 30.10.2015 Defer Date:12.05.2016 Decision :Deferred.

318

Case No.:87/16/82-

ALC4/2015
Party Name:SCOTT-EDIL PHARMACIA LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01407/AM16/
RLA File :22/24/040/00020/AM16/
Lic.No/Date:2210015341 30.10.2015 Defer Date:12.05.2016

319

Case No.:159/14/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01295/AM16/
RLA File :05/24/040/00343/AM16/
Lic.No/Date:0510396075 30.10.2015 Defer Date:12.05.2016

320

Case No.:118/16/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01438/AM16/
RLA File :05/24/040/00345/AM16/
Lic.No/Date:0510396076 30.10.2015 Defer Date:12.05.2016

321

Case No.:84/16/82-

ALC4/2015
Party Name:VENUS REMEDIES LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01404/AM16/
RLA File :22/24/040/00055/AM16/
Lic.No/Date:2210015339 30.10.2015 Defer Date:12.05.2016

322

Case No.:7/20/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01590/AM16/
RLA File :03/94/040/00552/AM16/
Lic.No/Date:0310799930 02.11.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/371/2015-PI(Norms) dated 15.3.2016 ,

323

Case No.:112/16/82-

ALC4/2015
Party Name:BELCO PHARMA Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01432/AM16/
RLA File :05/23/040/00273/AM16/
Lic.No/Date:0510396205 03.11.2015 Defer Date:12.05.2016

324

Case No.:107/16/82-

ALC4/2015
Party Name:HELLO PAINTS (P) LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01427/AM16/
RLA File :05/23/040/00326/AM16/
Lic.No/Date:0510396204 03.11.2015 Defer Date:12.05.2016 Decision :Deferred.

325

Case No.:19/16/82-

ALC4/2015
Party Name:MEDICLONE BIO-TECH PRIVATE LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01339/AM16/
RLA File :04/24/040/00181/AM16/
Lic.No/Date:0410161279 04.11.2015 Defer Date:12.05.2016

326 Case No.:90/16/82- Party Name:BEST Meet No/Date:1/82- Status:Case

ALC4/2015
VALUE CHEM PVT. LTD. ALC4/2016 07.04.2016 Deferred HQ File :01/82/050/01410/AM16/
RLA File :34/24/040/00207/AM16/
Lic.No/Date:3410041662 05.11.2015 Defer Date:12.05.2016 Decision :Deferred.

327

Case No.:108/16/82-

ALC4/2015
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01428/AM16/
RLA File :05/23/040/00330/AM16/
Lic.No/Date:0510396254 05.11.2015 Defer Date:12.05.2016 Decision : The Committee based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/696/2015-PI(Norms) dated 21.03.2016, uploaded at the end of these minutes decided to call for information from the firm and deferred the case.

328

Case No.:88/16/82-

ALC4/2015
Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01408/AM16/
RLA File :34/24/040/00202/AM16/
Lic.No/Date:3410041663 05.11.2015 Defer Date:12.05.2016

329

Case No.:49/16/82-

ALC4/2015
Party Name:UNIMAX LABORATORIES PVT.LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01369/AM16/
RLA File :03/95/040/00500/AM16/
Lic.No/Date:0310800048 05.11.2015 Defer Date:12.05.2016

330

Case No.:52/16/82-

ALC4/2015
Party Name:UNIMAX LABORATORIES PVT.LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01372/AM16/
RLA File :03/95/040/00555/AM16/
Lic.No/Date:0310800046 05.11.2015 Defer Date:12.05.2016

331

Case No.:37/16/82-

ALC4/2015
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01357/AM16/
RLA File :03/94/040/00561/AM16/
Lic.No/Date:0310800114 06.11.2015 Defer Date:12.05.2016

332

Case No.:53/16/82-

ALC4/2015
Party Name:LAXMI ORGANIC INDUSTRIES LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01373/AM16/
RLA File :03/95/040/00540/AM16/
Lic.No/Date:0310800090 06.11.2015 Defer Date:12.05.2016

333

Case No.:89/16/82-

ALC4/2015
Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01409/AM16/
RLA File :34/24/040/00203/AM16/
Lic.No/Date:3410041666 09.11.2015 Defer Date:12.05.2016 Decision :Deferred.

334

Case No.:2/16/82-

ALC4/2015
Party Name:SANO MEDICAL KITS PVT. LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01322/AM16/
RLA File :04/24/040/00175/AM16/
Lic.No/Date:0410161296 09.11.2015 Defer Date:12.05.2016

335

Case No.:34/1/82-

ALC1/2016
Party Name:GLAND PHARMA LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01808/AM16/
RLA File :09/24/040/00469/AM16/
Lic.No/Date:0910062848 10.11.2015 Defer Date 12.05.2016:

336

Case No.:18/16/82-

ALC4/2015
Party Name:CAPLIN POINT LABORATORIES LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01338/AM16/
RLA File :04/24/040/00172/AM16/
Lic.No/Date:0410161300 12.11.2015 Defer Date:12.05.2016

337

Case No.:110/16/82-

ALC4/2015
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01430/AM16/
RLA File :05/23/040/00329/AM16/
Lic.No/Date:0510396325 13.11.2015 Defer Date:12.05.2016

338

Case No.:106/16/82-

ALC4/2015
Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01426/AM16/
RLA File :05/24/040/00384/AM16/
Lic.No/Date:0510396340 16.11.2015 Defer Date:12.05.2016

339

Case No.:114/16/82-

ALC4/2015
Party Name:SHIVA BIOCHEM INDUSTRIES Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01434/AM16/
RLA File :50/24/040/00017/AM16/
Lic.No/Date:5010002240 16.11.2015 Defer Date:12.05.2016 Decision :Deferred.

340

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

LABORATORIES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01775/AM16/
RLA File :03/95/040/00591/AM16/
Lic.No/Date:0310800303 18.11.2015 Defer Date: Decision : The Committee decided to send a copy of application to DoP.

341

Case No.:52/20/82-

ALC4/2015
Party Name:RELIANCE INDUSTRIES LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01635/AM16/
RLA File :03/95/040/00551/AM16/
Lic.No/Date:0310800331 19.11.2015 Defer Date: Chemicals and Petrochemicals forwarded vide O.M. No.46011/6/2013-PC.II dated 05.04.2016,

342

Case No.:104/16/82-

ALC4/2015
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01424/AM16/
RLA File :05/23/040/00339/AM16/
Lic.No/Date:0510396384 20.11.2015 Defer Date:12.05.2016 Decision :Deferred.

343

Case No.:4/20/82-

ALC4/2015
Party Name:AIMS IMPEX PVT. LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01587/AM16/
RLA File :03/94/040/00656/AM16/
Lic.No/Date:0310800363 23.11.2015 Defer Date:12.05.2016 Decision :Deferred.

344

Case No.:103/16/82-

ALC4/2015
Party Name:JUBILANT GENERICS LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01423/AM16/
RLA File :05/23/040/00337/AM16/
Lic.No/Date:0510396395 23.11.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/365/2015-PI(Norms) dated 19.11.2015,

345

Case No.:31/1/82-

ALC1/2016
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01805/AM16/
RLA File :05/24/040/00347/AM16/
Lic.No/Date:0510396399 23.11.2015 Defer Date:12.05.2016 Decision :Deferred.

346 Case No.:2/20/82- ALC4/2015
Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:1/82- ALC4/2016 Status:Case Deferred

07.04.2016 HQ File :01/82/050/01585/AM16/
RLA File :05/24/040/00400/AM16/
Lic.No/Date:0510396400 23.11.2015 Defer Date:12.05.2016 Decision :Deferred.

347

Case No.:79/16/82-

ALC4/2015
Party Name:VENUS REMEDIES LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01399/AM16/
RLA File :22/24/040/00074/AM16/
Lic.No/Date:2210015349 23.11.2015 Defer Date:12.05.2016

348

Case No.:81/16/82-

ALC4/2015
Party Name:VENUS REMEDIES LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01401/AM16/
RLA File :22/24/040/00075/AM16/
Lic.No/Date:2210015348 23.11.2015 Defer Date:12.05.2016

349

Case No.:105/16/82-

ALC4/2015
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01425/AM16/
RLA File :05/23/040/00356/AM16/
Lic.No/Date:0510396410 24.11.2015 Defer Date:12.05.2016

350

Case No.:33/1/82-

ALC1/2016
Party Name:INCHEM LABORATORIES PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01807/AM16/
RLA File :09/24/040/00486/AM16/
Lic.No/Date:0910062902 26.11.2015 Defer Date:12.05.2016

351

Case No.:32/16/82-

ALC4/2015
Party Name:INTERMED, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01352/AM16/
RLA File :04/24/040/00177/AM16/
Lic.No/Date:0410161343 26.11.2015 Defer Date:12.05.2016

352

Case No.:2/1/82-

ALC1/2016
Party Name:UNIJULES LIFE SCIENCES LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01776/AM16/
RLA File :03/95/040/00632/AM16/
Lic.No/Date:0310800416 26.11.2015 Defer Date:12.05.2016

353

Case No.:23/1/82-

ALC1/2016
Party Name:UNILINK PHARMA PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred

HQ File :01/82/050/01797/AM16/
RLA File :04/24/040/00170/AM16/
Lic.No/Date:0410161342 26.11.2015 Defer Date:12.05.2016

354

Case No.:57/20/82-

ALC4/2015
Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01640/AM16/
RLA File :03/95/040/00628/AM16/
Lic.No/Date:0310800470 30.11.2015 Defer Date:12.05.2016

355

Case No.:58/20/82-

ALC4/2015
Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01641/AM16/
RLA File :03/95/040/00182/AM15/
Lic.No/Date:0310800550 01.12.2015 Defer Date:12.05.2016 Decision :Deferred.

356

Case No.:3/1/82-

ALC1/2016
Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01777/AM16/
RLA File :03/95/040/00529/AM15/
Lic.No/Date:0310800547 01.12.2015 Defer Date:12.05.2016 Decision :Deferred.

357

Case No.:5/1/82-

ALC1/2016
Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01779/AM16/
RLA File :03/95/040/00239/AM15/
Lic.No/Date:0310800551 01.12.2015 Defer Date:12.05.2016 Decision :Deferred.

358

Case No.:90/20/82-

ALC4/2015
Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01673/AM16/
RLA File :03/95/040/00629/AM16/
Lic.No/Date:0310800552 01.12.2015 Defer Date:12.05.2016

359

Case No.:3/20/82-

ALC4/2015
Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01586/AM16/
RLA File :22/24/040/00062/AM16/
Lic.No/Date:2210015358 02.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/342/2013-PI(Norms) dated 26.09.2013,

360

Case No.:33/20/82-

ALC4/2015
Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01616/AM16/
RLA File :03/94/040/00532/AM16/
Lic.No/Date:0310800597 02.12.2015 Defer Date:12.05.2016 Decision :Deferred.

361

Case No.:88/20/82-

ALC4/2015
Party Name:LUPIN LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01671/AM16/
RLA File :03/95/040/00452/AM16/
Lic.No/Date:0310800578 02.12.2015 Defer Date:12.05.2016

362

Case No.:54/20/82-

ALC4/2015
Party Name:MELOG SPECIALITY CHEMICALS PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01637/AM16/
RLA File :03/95/040/00631/AM16/
Lic.No/Date:0310800619 03.12.2015 Defer Date:12.05.2016 Decision :Deferred.

363

Case No.:112/20/82-

ALC4/2015
Party Name:SUPREET CHEMICALS PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01695/AM16/
RLA File :03/95/040/00646/AM16/
Lic.No/Date:0310800620 03.12.2015 Defer Date:12.05.2016 Decision :Deferred.

364

Case No.:89/20/82-

ALC4/2015
Party Name:MANGALAM DRUGS & ORGANICS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01672/AM16/
RLA File :03/95/040/00524/AM16/
Lic.No/Date:0310800661 04.12.2015 Defer Date:12.05.2016

365

Case No.:86/20/82-

ALC4/2015
Party Name:REANNON PHARMACEUTICALS Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01669/AM16/
RLA File :03/95/040/00494/AM16/
Lic.No/Date:0310800662 04.12.2015 Defer Date:12.05.2016

366

Case No.:62/20/82-

ALC4/2015
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01645/AM16/
RLA File :03/95/040/00522/AM16/
Lic.No/Date:0310800711 07.12.2015 Defer Date:12.05.2016

Decision :Deferred.

367

Case No.:87/20/82-

ALC4/2015
Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01670/AM16/
RLA File :03/95/040/00605/AM16/
Lic.No/Date:0310800715 07.12.2015 Defer Date:12.05.2016 Decision :Deferred.

368

Case No.:35/20/82-

ALC4/2015
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01618/AM16/
RLA File :03/94/040/00480/AM16/
Lic.No/Date:0310800769 08.12.2015 Defer Date:12.05.2016 Decision :Deferred.

369

Case No.:127/16/82-

ALC4/2015
Party Name:BLUELINE FOODS (INDIA) PVT.LTD, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01447/AM16/
RLA File :07/24/040/00267/AM16/
Lic.No/Date:0710109146 08.12.2015 Defer Date:12.05.2016

370

Case No.:34/20/82-

ALC4/2015
Party Name:JESONS INDUSTRIES LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01617/AM16/
RLA File :03/94/040/00682/AM16/
Lic.No/Date:0310800771 08.12.2015 Defer Date:12.05.2016 Decision :Deferred.

371

Case No.:85/20/82-

ALC4/2015
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01668/AM16/
RLA File :03/95/040/00201/AM16/
Lic.No/Date:0310800751 08.12.2015 Defer Date:12.05.2016 Decision :Deferred.

372

Case No.:109/20/82-

ALC4/2015
SCIENCES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01692/AM16/
RLA File :09/24/040/00505/AM16/
Lic.No/Date:0910062944 08.12.2015 Defer Date:12.05.2016

373

Case No.:36/20/82-

ALC4/2015
Party Name:BAYER VAPI PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01619/AM16/
RLA File :03/94/040/00651/AM16/
Lic.No/Date:0310800833 09.12.2015 Defer Date:12.05.2016

Decision :Deferred.

374

Case No.:61/20/82-

ALC4/2015
Party Name:PRASOL CHEMICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01644/AM16/
RLA File :03/95/040/00683/AM16/
Lic.No/Date:0310800825 09.12.2015 Defer Date:12.05.2016 Decision :Deferred.

375

Case No.:67/20/82-

ALC4/2015
Party Name:MANGALAM ORGANICS LIMITED (FORMERLY DUJODWALA Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01650/AM16/
RLA File :03/95/040/00054/AM16/
Lic.No/Date:0310800865 10.12.2015 Defer Date:12.05.2016 Decision :Deferred.

376

Case No.:108/20/82-

ALC4/2015
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01691/AM16/
RLA File :09/24/040/00506/AM16/
Lic.No/Date:0910062961 10.12.2015 Defer Date:12.05.2016

377

Case No.:59/20/82-

ALC4/2015
Party Name:PRASOL CHEMICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01642/AM16/
RLA File :03/95/040/00593/AM16/
Lic.No/Date:0310800879 10.12.2015 Defer Date:12.05.2016 Decision :Deferred.

378

Case No.:68/20/82-

ALC4/2015
Party Name:PRASOL CHEMICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01651/AM16/
RLA File :03/95/040/00684/AM16/
Lic.No/Date:0310800864 10.12.2015 Defer Date:12.05.2016 Decision :Deferred.

379

Case No.:110/20/82-

ALC4/2015
Party Name:PROCESS AGROCHEM INDUSTRIES PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01693/AM16/
RLA File :56/24/040/00040/AM16/
Lic.No/Date:5610004767 10.12.2015 Defer Date:12.05.2016

380

Case No.:70/20/82-

ALC4/2015
Party Name:SUNSHIELD CHEMICALS LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01653/AM16/
RLA File :03/95/040/00598/AM16/
Lic.No/Date:0310800862 10.12.2015 Defer Date:12.05.2016

Decision :Deferred.

381

Case No.:39/20/82-

ALC4/2015
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01622/AM16/
RLA File :03/94/040/00088/AM16/
Lic.No/Date:0310800889 11.12.2015 Defer Date:12.05.2016 Decision :Deferred.

382

Case No.:41/20/82-

ALC4/2015
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01624/AM16/
RLA File :03/94/040/00648/AM16/
Lic.No/Date:0310800905 11.12.2015 Defer Date:12.05.2016 Decision :Deferred.

383

Case No.:9/1/82-

ALC1/2016
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01783/AM16/
RLA File :03/94/040/00490/AM16/
Lic.No/Date:0310800912 11.12.2015 Defer Date:12.05.2016 Decision :Deferred.

384

Case No.:66/20/82-

ALC4/2015
Party Name:PRIVI ORGANICS LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01649/AM16/
RLA File :03/95/040/00633/AM16/
Lic.No/Date:0310800935 11.12.2015 Defer Date:12.05.2016 Decision :Deferred.

385

Case No.:45/20/82-

ALC4/2015
Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01628/AM16/
RLA File :03/94/040/00736/AM16/
Lic.No/Date:0310800992 14.12.2015 Defer Date:12.05.2016 Decision :Deferred.

386

Case No.:63/20/82-

ALC4/2015
Party Name:MANGALAM DRUGS & ORGANICS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01646/AM16/
RLA File :03/95/040/00673/AM16/
Lic.No/Date:0310800977 14.12.2015 Defer Date:12.05.2016

387

Case No.:24/20/82-

ALC4/2015
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01607/AM16/
RLA File :03/95/040/00088/AM16/
Lic.No/Date:0310800991 14.12.2015 Defer Date:12.05.2016

Decision :Deferred.

388

Case No.:69/20/82-

ALC4/2015
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01652/AM16/
RLA File :03/95/040/00661/AM16/
Lic.No/Date:0310800980 14.12.2015 Defer Date:12.05.2016 Decision :Deferred.

389

Case No.:4/1/82-

ALC1/2016
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01778/AM16/
RLA File :03/95/040/00660/AM16/
Lic.No/Date:0310800993 14.12.2015 Defer Date:12.05.2016 Decision :Deferred.

390

Case No.:64/20/82-

ALC4/2015
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01647/AM16/
RLA File :03/95/040/00702/AM16/
Lic.No/Date:0310801034 15.12.2015 Defer Date:12.05.2016 Decision :Deferred.

391

Case No.:65/20/82-

ALC4/2015
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01648/AM16/
RLA File :03/95/040/00703/AM16/
Lic.No/Date:0310801051 15.12.2015 Defer Date:12.05.2016 Decision :Deferred.

392

Case No.:49/20/82-

ALC4/2015
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01632/AM16/
RLA File :03/94/040/00714/AM16/
Lic.No/Date:0310801093 16.12.2015 Defer Date:12.05.2016

393

Case No.:10/1/82-

ALC1/2016
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01784/AM16/
RLA File :03/94/040/00630/AM16/
Lic.No/Date:0310801130 16.12.2015 Defer Date:12.05.2016

394 Case No.:44/20/82- ALC4/2015
Party Name:CELOGEN PHARMA PVT.LTD. Meet No/Date:1/82- ALC4/2016 Status:Case Deferred

07.04.2016 HQ File :01/82/050/01627/AM16/
RLA File :03/94/040/00720/AM16/
Lic.No/Date:0310801132 16.12.2015 Defer Date:12.05.2016

395

Case No.:74/20/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01657/AM16/
RLA File :03/94/040/00684/AM16/
Lic.No/Date:0310801092 16.12.2015 Defer Date:12.05.2016

396

Case No.:75/20/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01658/AM16/
RLA File :03/94/040/00695/AM16/
Lic.No/Date:0310801091 16.12.2015 Defer Date:12.05.2016

397

Case No.:46/20/82-

ALC4/2015
Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01629/AM16/
RLA File :03/94/040/00692/AM16/
Lic.No/Date:0310801111 16.12.2015 Defer Date:12.05.2016 Decision :Defered.

398

Case No.:120/20/82-

ALC4/2015
Party Name:MAITHRI LABORATORIES (P) LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01703/AM16/
RLA File :09/24/040/00524/AM16/
Lic.No/Date:0910062974 16.12.2015 Defer Date:12.05.2016

399

Case No.:23/20/82-

ALC4/2015
Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01606/AM16/
RLA File :03/95/040/00697/AM16/
Lic.No/Date:0310801116 16.12.2015 Defer Date:12.05.2016 Decision :Deferred.

400

Case No.:8/20/82-

ALC4/2015
Party Name:SHREE BANKEY BEHARI LAL BOARD MILLS Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01591/AM16/
RLA File :05/24/040/00427/AM16/
Lic.No/Date:0510396637 16.12.2015 Defer Date:12.05.2016 Decision :Deferred.

401

Case No.:135/16/82-

ALC4/2015
Party Name:METROCHEM API PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred

HQ File :01/82/050/01455/AM16/
RLA File :09/24/040/00534/AM16/
Lic.No/Date:0910062981 17.12.2015 Defer Date:12.05.2016 Decision :Deferred.

402

Case No.:136/16/82-

ALC4/2015
Party Name:METROCHEM API PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01456/AM16/
RLA File :09/24/040/00533/AM16/
Lic.No/Date:0910062980 17.12.2015 Defer Date:12.05.2016 Decision :Deferred.

403

Case No.:8/1/82-

ALC1/2016
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01782/AM16/
RLA File :03/94/040/00754/AM16/
Lic.No/Date:0310801214 18.12.2015 Defer Date:12.05.2016 Decision :Deferred.

404

Case No.:73/20/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01656/AM16/
RLA File :03/94/040/00697/AM16/
Lic.No/Date:0310801217 18.12.2015 Defer Date:12.05.2016

405

Case No.:83/1/82-

ALC1/2016
Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01857/AM16/
RLA File :03/94/040/00752/AM16/
Lic.No/Date:0310801211 18.12.2015 Defer Date:12.05.2016 Decision :Deferred.

406

Case No.:14/20/82-

ALC4/2015
Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01597/AM16/
RLA File :03/94/040/00728/AM16/
Lic.No/Date:0310801252 21.12.2015 Defer Date:12.05.2016

407

Case No.:30/1/82-

ALC1/2016
Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01804/AM16/
RLA File :07/24/040/00198/AM16/
Lic.No/Date:0710109193 22.12.2015 Defer Date:12.05.2016

408

Case No.:15/20/82-

ALC4/2015
Party Name:CELOGEN PHARMA PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:0310801298 Defer

:01/82/050/01598/AM16/ :03/94/040/00721/AM16/ 22.12.2015 Date:12.05.2016

409

Case No.:19/20/82-

ALC4/2015
Party Name:LAXMI ORGANIC INDUSTRIES LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01602/AM16/
RLA File :03/95/040/00009/AM16/
Lic.No/Date:0310801275 22.12.2015 Defer Date:12.05.2016 Decision :Deferred.

410

Case No.:20/20/82-

ALC4/2015
Party Name:LAXMI ORGANIC INDUSTRIES LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01603/AM16/
RLA File :03/95/040/00267/AM16/
Lic.No/Date:0310801273 22.12.2015 Defer Date:12.05.2016 Decision :Deferred.

411

Case No.:111/20/82-

ALC4/2015
Party Name:PARENTRAL DRUGS INDIA LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01694/AM16/
RLA File :56/24/040/00045/AM16/
Lic.No/Date:5610004780 22.12.2015 Defer Date:12.05.2016

412

Case No.:48/20/82-

ALC4/2015
Party Name:ALCHEMIE LABORATORIES Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01631/AM16/
RLA File :03/94/040/00683/AM16/
Lic.No/Date:0310801362 28.12.2015 Defer Date:12.05.2016

413

Case No.:17/20/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01600/AM16/
RLA File :03/94/040/00767/AM16/
Lic.No/Date:0310801358 28.12.2015 Defer Date:12.05.2016

414

Case No.:18/20/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01601/AM16/
RLA File :03/94/040/00781/AM16/
Lic.No/Date:0310801341 28.12.2015 Defer Date:12.05.2016

415

Case No.:71/20/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01654/AM16/
RLA File :03/94/040/00698/AM16/
Lic.No/Date:0310801355 28.12.2015 Defer Date:12.05.2016

416

Case No.:72/20/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01655/AM16/
RLA File :03/94/040/00768/AM16/
Lic.No/Date:0310801340 28.12.2015 Defer Date:12.05.2016

417

Case No.:16/20/82-

ALC4/2015
Party Name:FINE ORGANIC INDUSTRIES PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01599/AM16/
RLA File :03/94/040/00780/AM16/
Lic.No/Date:0310801349 28.12.2015 Defer Date:12.05.2016 Decision :Deferred.

418

Case No.:131/16/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01451/AM16/
RLA File :09/24/040/00578/AM16/
Lic.No/Date:0910063038 28.12.2015 Defer Date:12.05.2016

419

Case No.:102/20/82-

ALC4/2015
Party Name:STERMONE CHEMICALS PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01685/AM16/
RLA File :34/24/040/00243/AM16/
Lic.No/Date:3410041764 29.12.2015 Defer Date:12.05.2016

420

Case No.:80/20/82-

ALC4/2015
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01663/AM16/
RLA File :03/95/040/00736/AM16/
Lic.No/Date:0310801389 29.12.2015 Defer Date:12.05.2016 Decision :Deferred.

421

Case No.:81/20/82-

ALC4/2015
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01664/AM16/
RLA File :03/95/040/00735/AM16/
Lic.No/Date:0310801388 29.12.2015 Defer Date:12.05.2016 Decision :Deferred.

422

Case No.:22/20/82-

ALC4/2015
Party Name:S M B CORPORATION OF INDIA Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01605/AM16/
RLA File :03/95/040/00738/AM16/
Lic.No/Date:0310801409 30.12.2015 Defer Date:12.05.2016 Decision :Deferred.

423

Case No.:84/20/82-

ALC4/2015
Party Name:SIRMAXO CHEMICALS PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01667/AM16/
RLA File :03/95/040/00730/AM16/
Lic.No/Date:0310801411 30.12.2015 Defer Date:12.05.2016

424

Case No.:116/20/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01699/AM16/
RLA File :05/24/040/00463/AM16/
Lic.No/Date:0510397108 30.12.2015 Defer Date:12.05.2016

425

Case No.:117/20/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01700/AM16/
RLA File :05/24/040/00462/AM16/
Lic.No/Date:0510397106 30.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/588/2015-PI(Norms) dated 21.03.2016,

426

Case No.:47/20/82-

ALC4/2015
Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01630/AM16/
RLA File :03/94/040/00792/AM16/
Lic.No/Date:0310801428 31.12.2015 Defer Date:12.05.2016 Decision :Deferred.

427

Case No.:92/20/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01675/AM16/
RLA File :03/94/040/00696/AM16/
Lic.No/Date:0310801442 31.12.2015 Defer Date:12.05.2016

428

Case No.:98/20/82-

ALC4/2015
Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01681/AM16/
RLA File :05/23/040/00338/AM16/
Lic.No/Date:0510397164 31.12.2015 Defer Date:12.05.2016

429

Case No.:28/20/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved

HQ File :01/82/050/01611/AM16/
RLA File :03/94/040/00799/AM16/
Lic.No/Date:0310801430 31.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/636/2015-PI(Norms) dated 14.03.2016 ,

430

Case No.:99/20/82-

ALC4/2015
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01682/AM16/
RLA File :05/23/040/00389/AM16/
Lic.No/Date:0510397158 31.12.2015 Defer Date:12.05.2016

431

Case No.:101/20/82-

ALC4/2015
Party Name:SONGWON SPECIALTY CHEMICALS INDIA PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01684/AM16/
RLA File :34/24/040/00226/AM16/
Lic.No/Date:3410041775 31.12.2015 Defer Date:12.05.2016 Decision :Deferred.

432

Case No.:119/20/82-

ALC4/2015
Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01702/AM16/
RLA File :09/24/040/00582/AM16/
Lic.No/Date:0910063066 31.12.2015 Defer Date:12.05.2016 Decision :Deferred.

433

Case No.:77/20/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01660/AM16/
RLA File :03/94/040/00788/AM16/
Lic.No/Date:0310801491 01.01.2016 Defer Date:12.05.2016

434

Case No.:91/20/82-

ALC4/2015
Party Name:CIPLA LIMITED. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01674/AM16/
RLA File :03/94/040/00789/AM16/
Lic.No/Date:0310801492 01.01.2016 Defer Date:12.05.2016

435

Case No.:118/20/82-

ALC4/2015
Party Name:AMI LIFESCIENCES P LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01701/AM16/
RLA File :34/24/040/00256/AM16/
Lic.No/Date:3410041779 04.01.2016 Defer Date:12.05.2016

436

Case No.:104/20/82-

ALC4/2015
Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01687/AM16/
RLA File :34/24/040/00253/AM16/
Lic.No/Date:3410041778 04.01.2016 Defer Date:12.05.2016

437

Case No.:27/20/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01610/AM16/
RLA File :03/94/040/00800/AM16/
Lic.No/Date:0310801515 04.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/371/2015-PI(Norms) dated 15.03.2016,

438

Case No.:82/20/82-

ALC4/2015
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01665/AM16/
RLA File :03/95/040/00750/AM16/
Lic.No/Date:0310801522 04.01.2016 Defer Date:12.05.2016 Decision :Deferred.

439

Case No.:83/20/82-

ALC4/2015
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01666/AM16/
RLA File :03/95/040/00749/AM16/
Lic.No/Date:0310801521 04.01.2016 Defer Date:12.05.2016 Decision :Deferred.

440

Case No.:105/20/82-

ALC4/2015
Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01688/AM16/
RLA File :34/24/040/00252/AM16/
Lic.No/Date:3410041782 05.01.2016 Defer Date:12.05.2016 Decision :Deferred.

441

Case No.:31/20/82-

ALC4/2015
Party Name:CTX LIFESCIENCES PVT LTD, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01614/AM16/
RLA File :03/94/040/00699/AM16/
Lic.No/Date:0310801560 05.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/413/2015-PI(Norms) dated 22.03.2016 ,

442 Case No.:32/20/82- ALC4/2015
Party Name:J.B. CHEMICALS & Meet No/Date:1/82- ALC4/2016 Status:Case Approved

PHARMACEUTICALS LIMITED 07.04.2016 HQ File :01/82/050/01615/AM16/
RLA File :03/94/040/00815/AM16/
Lic.No/Date:0310801571 05.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/383/2015-PI(Norms) dated 17.03.2016 and O.M. No.35011/396/2015-PI(Norms) dated 06.04.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

443

Case No.:78/20/82-

ALC4/2015
Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01661/AM16/
RLA File :03/95/040/00652/AM16/
Lic.No/Date:0310801554 05.01.2016 Defer Date:12.05.2016

444

Case No.:26/20/82-

ALC4/2015
Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01609/AM16/
RLA File :03/94/040/00802/AM16/
Lic.No/Date:0310801601 06.01.2016 Defer Date:12.05.2016 Decision :Deferred

445

Case No.:29/20/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01612/AM16/
RLA File :03/94/040/00814/AM16/
Lic.No/Date:0310801603 06.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/383/2015-PI(Norms) dated 17.03.2016 and O.M. No.35011/396/2015-PI(Norms) dated 06.04.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

446

Case No.:30/20/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01613/AM16/
RLA File :03/94/040/00817/AM16/
Lic.No/Date:0310801604 06.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/383/2015-PI(Norms) dated 17.03.2016 and O.M. No.35011/396/2015-PI(Norms) dated 06.04.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

447

Case No.:7/1/82-

ALC1/2016
Party Name:PRIVI ORGANICS LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred

HQ File :01/82/050/01781/AM16/
RLA File :03/95/040/00688/AM16/
Lic.No/Date:0310801600 06.01.2016 Defer Date:12.05.2016 Decision :Deferred.

448

Case No.:76/20/82-

ALC4/2015
Party Name:AIMS IMPEX PVT. LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01659/AM16/
RLA File :03/94/040/00790/AM16/
Lic.No/Date:0310801644 07.01.2016 Defer Date:12.05.2016 Decision :Deferred.

449

Case No.:42/20/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01625/AM16/
RLA File :03/94/040/00816/AM16/
Lic.No/Date:0310801629 07.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/383/2015-PI(Norms) dated 17.03.2016 and O.M. No.35011/396/2015-PI(Norms) dated 06.04.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

450

Case No.:103/20/82-

ALC4/2015
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01686/AM16/
RLA File :05/23/040/00404/AM16/
Lic.No/Date:0510397232 07.01.2016 Defer Date:12.05.2016 Decision : The Committee decided to defer the case for want of comment from DoP.

451

Case No.:6/1/82-

ALC1/2016
Party Name:MEDISPRAY LABORATORIES PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01780/AM16/
RLA File :03/95/040/00676/AM16/
Lic.No/Date:0310801634 07.01.2016 Defer Date:12.05.2016

452

Case No.:32/1/82-

ALC1/2016
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01806/AM16/
RLA File :05/24/040/00431/AM16/
Lic.No/Date:0510397230 07.01.2016 Defer Date:12.05.2016 Decision :Deferred.

453

Case No.:95/20/82-

ALC4/2015
Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01678/AM16/
RLA File :05/24/040/00499/AM16/
Lic.No/Date:0510397256 08.01.2016 Defer Date:12.05.2016

454

Case No.:79/20/82-

ALC4/2015
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01662/AM16/
RLA File :03/95/040/00765/AM16/
Lic.No/Date:0310801655 08.01.2016 Defer Date:12.05.2016 Decision :Deferred.

455

Case No.:21/20/82-

ALC4/2015
Party Name:SHREE LIFE SCIENCES PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01604/AM16/
RLA File :03/95/040/00762/AM16/
Lic.No/Date:0310801691 11.01.2016 Defer Date:12.05.2016

456

Case No.:19/1/82-

ALC1/2016
Party Name:STRIDES SHASUN LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01793/AM16/
RLA File :04/24/040/00214/AM16/
Lic.No/Date:0410161494 11.01.2016 Defer Date:12.05.2016

457

Case No.:60/1/82-

ALC1/2016
Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01834/AM16/
RLA File :03/94/040/00828/AM16/
Lic.No/Date:0310801732 12.01.2016 Defer Date:12.05.2016 Decision :Deferred.

458

Case No.:61/1/82-

ALC1/2016
Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01835/AM16/
RLA File :03/94/040/00820/AM16/
Lic.No/Date:0310801731 12.01.2016 Defer Date:12.05.2016 Decision :Deferred.

459

Case No.:48/1/82-

ALC1/2016
Party Name:INDO AMINES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01822/AM16/
RLA File :03/94/040/00785/AM16/
Lic.No/Date:0310801728 12.01.2016 Defer Date:12.05.2016 Decision :Deferred.

460

Case No.:82/1/82-

ALC1/2016
Party Name:PRIVI ORGANICS LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01856/AM16/
RLA File :03/95/040/00690/AM16/
Lic.No/Date:0310801719 12.01.2016 Defer Date:12.05.2016 Decision :Deferred.

461

Case No.:81/1/82-

ALC1/2016
Party Name:VITAL HEALTHCARE PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01855/AM16/
RLA File :03/95/040/00776/AM16/
Lic.No/Date:0310801722 12.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/719/2015-PI(Norms) dated 22.02.2016,

462

Case No.:62/1/82-

ALC1/2016
Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01836/AM16/
RLA File :03/94/040/00833/AM16/
Lic.No/Date:0310801811 15.01.2016 Defer Date:12.05.2016 Decision :Deferred.

463

Case No.:66/1/82-

ALC1/2016
Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01840/AM16/
RLA File :03/94/040/00831/AM16/
Lic.No/Date:0310801850 18.01.2016 Defer Date:12.05.2016 Decision :Deferred.

464

Case No.:64/1/82-

ALC1/2016
Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01838/AM16/
RLA File :03/94/040/00840/AM16/
Lic.No/Date:0310801857 18.01.2016 Defer Date:12.05.2016 Decision :Deferred.

465

Case No.:22/1/82-

ALC1/2016
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01796/AM16/
RLA File :04/24/040/00220/AM16/
Lic.No/Date:0410161521 18.01.2016 Defer Date:12.05.2016

466

Case No.:79/1/82-

ALC1/2016
Party Name:PRIVI ORGANICS LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01853/AM16/
RLA File :03/95/040/00689/AM16/
Lic.No/Date:0310801831 18.01.2016 Defer Date:12.05.2016 Decision :Deferred.

467 Case No.:80/1/82- ALC1/2016
Party Name:SUNSHIELD CHEMICALS LTD. Meet No/Date:1/82- ALC4/2016 Status:Case Deferred

07.04.2016 HQ File :01/82/050/01854/AM16/
RLA File :03/95/040/00771/AM16/
Lic.No/Date:0310801856 18.01.2016 Defer Date:12.05.2016 Decision :Deferred.

468

Case No.:63/1/82-

ALC1/2016
Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01837/AM16/
RLA File :03/94/040/00846/AM16/
Lic.No/Date:0310801882 19.01.2016 Defer Date:12.05.2016 Decision :Deferred.

469

Case No.:65/1/82-

ALC1/2016
Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01839/AM16/
RLA File :03/94/040/00857/AM16/
Lic.No/Date:0310801883 19.01.2016 Defer Date:12.05.2016 Decision :Deferred.

470

Case No.:59/1/82-

ALC1/2016
Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01833/AM16/
RLA File :03/94/040/00589/AM16/
Lic.No/Date:0310801896 19.01.2016 Defer Date:12.05.2016 Decision :Deferred.

471

Case No.:114/20/82-

ALC4/2015
Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01697/AM16/
RLA File :34/24/040/00263/AM16/
Lic.No/Date:3410041814 19.01.2016 Defer Date:12.05.2016 Decision :Deferred.

472

Case No.:77/1/82-

ALC1/2016
Party Name:MEDISPRAY LABORATORIES PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01851/AM16/
RLA File :03/95/040/00657/AM16/
Lic.No/Date:0310801888 19.01.2016 Defer Date:12.05.2016

473

Case No.:36/1/82-

ALC1/2016
Party Name:SI GROUP INDIA LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01810/AM16/
RLA File :03/95/040/00779/AM16/
Lic.No/Date:0310801890 19.01.2016 Defer Date:12.05.2016 Decision :Deferred.

474 Case No.:113/20/82- Party Name:STERMONE Meet No/Date:1/82- Status:Case

ALC4/2015
CHEMICALS PVT LTD ALC4/2016 07.04.2016 Deferred HQ File :01/82/050/01696/AM16/
RLA File :34/24/040/00177/AM16/
Lic.No/Date:3410041821 19.01.2016 Defer Date:12.05.2016 Decision : The Committee decided to send a copy of application to DoP.

475

Case No.:76/1/82-

ALC1/2016
Party Name:TITAN LABORATORIES PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01850/AM16/
RLA File :03/95/040/00790/AM16/
Lic.No/Date:0310801892 19.01.2016 Defer Date:12.05.2016

476

Case No.:50/1/82-

ALC1/2016
Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01824/AM16/
RLA File :03/94/040/00861/AM16/
Lic.No/Date:0310801928 20.01.2016 Defer Date:12.05.2016 Decision :Deferred.

477

Case No.:68/1/82-

ALC1/2016
Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01842/AM16/
RLA File :03/94/040/00834/AM16/
Lic.No/Date:0310801927 20.01.2016 Defer Date:12.05.2016 Decision :Deferred.

478

Case No.:106/20/82-

ALC4/2015
Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01689/AM16/
RLA File :05/24/040/00515/AM16/
Lic.No/Date:0510397367 20.01.2016 Defer Date:12.05.2016

479

Case No.:38/1/82-

ALC1/2016
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01812/AM16/
RLA File :03/95/040/00798/AM16/
Lic.No/Date:0310801923 20.01.2016 Defer Date:12.05.2016 Decision :Deferred.

480

Case No.:115/20/82-

ALC4/2015
Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01698/AM16/
RLA File :34/24/040/00268/AM16/
Lic.No/Date:3410041823 21.01.2016 Defer Date: 12.05.2016 Decision :The Committee deferred the case for want of comments of DoP.

481 Case No.:49/1/82- ALC1/2016
Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:1/82- ALC4/2016 Status:Case Deferred

07.04.2016 HQ File :01/82/050/01823/AM16/
RLA File :03/94/040/00869/AM16/
Lic.No/Date:0310801950 21.01.2016 Defer Date:12.05.2016 Decision :Deferred.

482

Case No.:47/1/82-

ALC1/2016
Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01821/AM16/
RLA File :03/94/040/00864/AM16/
Lic.No/Date:0310801994 22.01.2016 Defer Date:12.05.2016 Decision :Deferred.

483

Case No.:2/18/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01467/AM16/
RLA File :09/24/040/00617/AM16/
Lic.No/Date:0910063157 22.01.2016 Defer Date:
Decision : Committee decided to send a copy of application to DOP.

484

Case No.:67/1/82-

ALC1/2016
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01841/AM16/
RLA File :03/94/040/00880/AM16/
Lic.No/Date:0310802014 22.01.2016 Defer Date:12.05.2016 Decision : The committee deferred the case for want of comment of DoP.

485

Case No.:24/1/82-

ALC1/2016
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01798/AM16/
RLA File :04/24/040/00210/AM16/
Lic.No/Date:0410161548 22.01.2016 Defer Date:12.05.2016 Decision : The committee deferred the case for want of comment of DoP.

486

Case No.:97/20/82-

ALC4/2015
Party Name:SHREE BANKEY BEHARI LAL AROMATICS Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01680/AM16/
RLA File :05/24/040/00522/AM16/
Lic.No/Date:0510397405 22.01.2016 Defer Date:12.05.2016 Decision :Deferred.

487

Case No.:96/20/82-

ALC4/2015
Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01679/AM16/
RLA File :02/24/040/00178/AM16/
Lic.No/Date:0210206458 22.01.2016 Defer Date:12.05.2016 Decision : The committee deferred the case for want of comment of DoP.

488 Case No.:51/1/82- Party Name:BDR Meet No/Date:1/82- Status:Case

ALC1/2016
PHARMACEUTICALS INTERNATIONAL PVT. LTD. ALC4/2016 07.04.2016 Deferred HQ File :01/82/050/01825/AM16/
RLA File :03/94/040/00877/AM16/
Lic.No/Date:0310802029 25.01.2016 Defer Date:12.05.2016 Decision :Deferred.

489

Case No.:52/1/82-

ALC1/2016
Party Name:INDO AMINES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01826/AM16/
RLA File :03/94/040/00888/AM16/
Lic.No/Date:0310802024 25.01.2016 Defer Date:12.05.2016 Decision :Deferred.

490

Case No.:53/1/82-

ALC1/2016
Party Name:DR. ACHARYA LABORATORIES PVT. LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01827/AM16/
RLA File :03/94/040/00881/AM16/
Lic.No/Date:0310802057 27.01.2016 Defer Date:12.05.2016 Decision : The committee deferred the case for want of comment of DoP.

491

Case No.:27/1/82-

ALC1/2016
Party Name:BODAL CHEMICALS LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01801/AM16/
RLA File :08/24/040/00325/AM16/
Lic.No/Date:0810137105 01.02.2016 Defer Date:12.05.2016 Decision :Deferred.

492

Case No.:44/1/82-

ALC1/2016
Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01818/AM16/
RLA File :03/94/040/00886/AM16/
Lic.No/Date:0310802172 02.02.2016 Defer Date:12.05.2016 Decision :Deferred.

493

Case No.:40/1/82-

ALC1/2016
Party Name:MAGNOLIA LIMITED. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01814/AM16/
RLA File :03/95/040/01074/AM15/
Lic.No/Date:0310802175 02.02.2016 Defer Date:12.05.2016 Decision :Deferred.

494

Case No.:35/1/82-

ALC1/2016
Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01809/AM16/
RLA File :31/82/040/00270/AM16/
Lic.No/Date:3110065907 04.02.2016 Defer Date:12.05.2016 Decision: The Committee deferred the case for want of comments of DoP.

495

Case No.:37/1/82-

ALC1/2016
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01811/AM16/
RLA File :03/95/040/00639/AM16/
Lic.No/Date:0310802231 04.02.2016 Defer Date:12.05.2016 Decision :Deferred.

496

Case No.:43/1/82-

ALC1/2016
Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01817/AM16/
RLA File :03/94/040/00882/AM16/
Lic.No/Date:0310802261 05.02.2016 Defer Date:12.05.2016 Decision : The Committee deferred the case for want of comments of DoP.

497

Case No.:11/1/82-

ALC1/2016
Party Name:GANGWAL CHEMICALS (P) LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01785/AM16/
RLA File :03/94/040/00919/AM16/
Lic.No/Date:0310802255 05.02.2016 Defer Date:12.05.2016 Decision :Deferred.

498

Case No.:58/1/82-

ALC1/2016
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01832/AM16/
RLA File :03/95/040/00819/AM16/
Lic.No/Date:0310802266 05.02.2016 Defer Date:12.05.2016 Decision :Deferred.

499

Case No.:42/1/82-

ALC1/2016
Party Name:CELOGEN PHARMA PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01816/AM16/
RLA File :03/94/040/00929/AM16/
Lic.No/Date:0310802331 08.02.2016 Defer Date:12.05.2016 Decision :Deferred.

500

Case No.:46/1/82-

ALC1/2016
Party Name:ENALTEC LABS PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01820/AM16/
RLA File :03/94/040/00906/AM16/
Lic.No/Date:0310802288 08.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/748/2015-PI(Norms) dated 03.03.2016,

501

Case No.:69/1/82-

ALC1/2016
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:0310802291 Defer

:01/82/050/01843/AM16/ :03/94/040/00922/AM16/ 08.02.2016 Date:12.05.2016 Decision : The Committee decided to send a copy of application to MSME.

502

Case No.:74/1/82-

ALC1/2016
Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01848/AM16/
RLA File :03/94/040/00810/AM16/
Lic.No/Date:0310802333 08.02.2016 Defer Date:12.05.2016 Decision :Deferred.

503

Case No.:39/1/82-

ALC1/2016
Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01813/AM16/
RLA File :03/95/040/00847/AM16/
Lic.No/Date:0310802292 08.02.2016 Defer Date:12.05.2016 Decision :Deferred.

504

Case No.:75/1/82-

ALC1/2016
Party Name:BLISS GVS PHARMA LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01849/AM16/
RLA File :03/94/040/00948/AM16/
Lic.No/Date:0310802382 09.02.2016 Defer Date:12.05.2016

505

Case No.:71/1/82-

ALC1/2016
Party Name:HALCYON LABS PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01845/AM16/
RLA File :03/94/040/00916/AM16/
Lic.No/Date:0310802390 09.02.2016 Defer Date:12.05.2016

506

Case No.:72/1/82-

ALC1/2016
Party Name:HALCYON LABS PVT. LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01846/AM16/
RLA File :03/94/040/00915/AM16/
Lic.No/Date:0310802387 09.02.2016 Defer Date:12.05.2016

507

Case No.:45/1/82-

ALC1/2016
Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01819/AM16/
RLA File :03/94/040/00859/AM16/
Lic.No/Date:0310802380 09.02.2016 Defer Date:12.05.2016 Decision :Deferred.

508

Case No.:70/1/82-

ALC1/2016
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:0310802452 Defer

:01/82/050/01844/AM16/ :03/94/040/00935/AM16/ 10.02.2016 Date:12.05.2016

509

Case No.:2/1/82-ALC4/2016 Party Name:GRANULES

INDIA LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01861/AM16/
RLA File :09/24/040/00667/AM16/
Lic.No/Date:0910063236 10.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/746/2015-PI(Norms) dated 7.03.2016, uploaded

510

Case No.:41/1/82-

ALC1/2016
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01815/AM16/
RLA File :03/95/040/00826/AM16/
Lic.No/Date:0310802395 10.02.2016 Defer Date:12.05.2016 Decision :Deferred.

511

Case No.:78/1/82-

ALC1/2016
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01852/AM16/
RLA File :03/95/040/00752/AM16/
Lic.No/Date:0310802451 10.02.2016 Defer Date:12.05.2016 Decision :Deferred.

512

Case No.:55/1/82-

ALC1/2016
Party Name:UNIMAX LABORATORIES PVT.LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01829/AM16/
RLA File :03/95/040/00846/AM16/
Lic.No/Date:0310802440 10.02.2016 Defer Date:12.05.2016

513

Case No.:73/1/82-

ALC1/2016
Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01847/AM16/
RLA File :03/94/040/00953/AM16/
Lic.No/Date:0310802552 12.02.2016 Defer Date:12.05.2016 Decision :Deferred.

514

Case No.:26/1/82-

ALC1/2016
Party Name:UMA ENTERPRISE Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01800/AM16/
RLA File :08/24/040/00396/AM16/
Lic.No/Date:0810137202 15.02.2016 Defer Date:12.05.2016 Decision :Deferred.

515

Case No.:56/1/82-

ALC1/2016
Party Name:ZIM LABORATORIES LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01830/AM16/
RLA File :03/95/040/00887/AM16/
Lic.No/Date:0310802649 16.02.2016 Defer Date:12.05.2016

516

Case No.:17/1/82-

ALC1/2016
Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01791/AM16/
RLA File :04/24/040/00229/AM16/
Lic.No/Date:0410161613 17.02.2016 Defer Date:12.05.2016 Decision :Deferred.

517

Case No.:57/1/82-

ALC1/2016
Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01831/AM16/
RLA File :03/95/040/00895/AM16/
Lic.No/Date:0310802676 17.02.2016 Defer Date:12.05.2016 Decision :Deferred.

518

Case No.:54/1/82-

ALC1/2016
Party Name:SUPRIYA LIFESCIENCE LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01828/AM16/
RLA File :03/95/040/00825/AM16/
Lic.No/Date:0310802720 19.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/741/2015-PI(Norms) dated 19.02.2016,

519

Case No.:1/20/82-

ALC4/2015
Party Name:DIVIS LABORATORIES LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01584/AM16/
RLA File :09/24/040/00689/AM16/
Lic.No/Date:0910063311 22.02.2016 Defer Date:12.05.2016

520

Case No.:1/1/82-

ALC4/2016
Party Name:GRANULES INDIA LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01860/AM16/
RLA File :09/24/040/00687/AM16/
Lic.No/Date:0910063325 24.02.2016 Defer Date:12.05.2016 Pharmaceuticals forwarded vide O.M. No.35011/746/2015-PI(Norms) dated 7.03.2016, uploaded

521

Case No.:18/1/82-

ALC1/2016
Party Name:STRIDES SHASUN LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01792/AM16/
RLA File :04/24/040/00248/AM16/
Lic.No/Date:0410161671 01.03.2016 Defer Date:12.05.2016

522

Case No.:20/1/82-

ALC1/2016
Party Name:STRIDES SHASUN LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01794/AM16/
RLA File :04/24/040/00247/AM16/
Lic.No/Date:0410161672 01.03.2016 Defer Date:12.05.2016

523

Case No.:21/1/82-

ALC1/2016
Party Name:STRIDES SHASUN LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01795/AM16/
RLA File :04/24/040/00246/AM16/
Lic.No/Date:0410161670 01.03.2016 Defer Date:12.05.2016

524

Case No.:3/1/82-ALC4/2016 Party Name:ORCH

LABORATORIES INDIA PVT LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01862/AM16/
RLA File :09/24/040/00704/AM16/
Lic.No/Date:0910063356 03.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/601/2014-PI(Norms) dated April, 2015,

525

Case No.:12/1/82-

ALC1/2016
Party Name:VASUDHA PHARMA CHEM LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Approved HQ File :01/82/050/01786/AM16/
RLA File :09/24/040/00699/AM16/
Lic.No/Date:0910063386 10.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/641/2015-PI(Norms) dated December 2015,

526

Case No.:13/1/82-

ALC1/2016
Party Name:ONEIRO CHEMICALS LTD Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01787/AM16/
RLA File :34/24/040/00286/AM16/
Lic.No/Date:3410041972 14.03.2016 Defer Date:12.05.2016

527

Case No.:15/1/82-

ALC1/2016
Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01789/AM16/
RLA File :09/24/040/00713/AM16/
Lic.No/Date:0910063416 15.03.2016 Defer Date:12.05.2016

528

Case No.:14/1/82-

ALC1/2016
Party Name:DIVIS LABORATORIES LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01788/AM16/
RLA File :09/24/040/00716/AM16/
Lic.No/Date:0910063414 15.03.2016 Defer Date:12.05.2016

529

Case No.:85/1/82-

ALC1/2016
Party Name:DIVIS LABORATORIES LTD., Meet No/Date:1/82- ALC4/2016 07.04.2016 Status:Case Deferred HQ File :01/82/050/01859/AM16/
RLA File :09/24/040/00730/AM16/
Lic.No/Date:0910063440 23.03.2016 Defer Date:12.05.2016

Manual Agenda of NC Meeting No. 1/82/2016 Held on 07.04.2016

Case No. B- 01

M.No.1/AM-17 Date 07.04.2016

M/s. Yasho Industries Pvt Ltd File No. 01/82/050/01121/AM13 RLA No 03/95/040/00735/AM13 Adv.Auth. No. 0310718082 dated 24.12.2012

Decision: The Committee considered the representation of the firm for ratification of norms under Para 4.07 of HBP. The committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/95/2011-Ch-II dated 23.11.2015, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No. B- 02

M.No.1/AM-17 Date 07.04.2016

M/s. Aurobindo Pharma Ltd File No. 01/82/050/00826/AM16 RLA No 09/24/040/00058/AM16 Adv.Auth. No. 0910062018 dated 14.05.2015

Decision: The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/651/2015-PI(Norms) dated 01.02.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No. B- 03

M.No.1/AM-17 Date 07.04.2016 M/s. SMB Corporation of India File No. 01/82/050/01016/AM13 RLA No 03/95/040/00568/AM13

Adv.Auth. No. 0310713614 dated 25.10.2012

Decision: The Committee considered this case for amendment of UOM of export product as per agenda.
The Committee deferred the case.

Case No. B- 04

M.No.1/AM-17 Date 07.04.2016

M/s. Meteropolitan Exichem Ltd File No. 01/82/050/01085/AM14 RLA No 03/95/040/00736/AM14 Adv.Auth. No. 0310762602 dated 19.12.2013

Decision: The Committee considered this case for correction of norms of ratified by NC in earlier as per agenda. The Committee deferred the case.

Case No. B- 05

M.No.1/AM-17 Date 07.04.2016

M/s. Bharat Parenterals Ltd File No. 01/82/162/00279/AM16 RLA No 34/21/040/00131/AM15 Adv.Auth. No. 3410040292 dated 20.06.2014

Decision: The Committee considered this case for amendment of the description of export product as per agenda. The Committee noted that both the items are liquid preparations. The Export Product is under a valid DML which indicates two composition of the liquid preparation. For the purpose of closure, the wastage of 5% on the API (bulk drugs) may be permitted. RA concerned take action as per the decision.

Case No. B- 06

M.No.1/AM-17 Date 07.04.2016

M/s. Bharat Parenterals Ltd File No. 01/82/162/00278/AM16 RLA No 34/21/040/00246/AM15 Adv.Auth. No. 3410040492 dated 27.08.2014

Decision: The Committee noted that the issue is regarding UOI being IU instead of mg/kg. The firm has submitted the explanation in their letter dated 01.01.2016, stating that conversion of IU to mg is given in the Pharmacopia, which the RA may verify. The converted strength in mg can be multiplied by number of tablets. RA may proactively examine the matter in terms of DoP O.M.No.35011/714/2015-PI(Norms) dated 25.2.2016.

Case No. B- 07

M.No.1/AM-17 Date 07.04.2016

M/s. Bharat Parenterals Ltd File No. 01/82/162/00270/AM16 RLA No 34/21/040/00282/AM14 Adv.Auth. No. 3410038122 dated 04.10.2013

Case No. B- 08

M.No.1/AM-17 Date 07.04.2016

M/s. Pace Pharmatech Pvt Ltd File No. 01/82/050/00875/AM15 RLA No 03/95/040/00347/AM15 Adv.Auth. No. 0310787160 dated 22.07.2014

Decision: The Committee considered the case for ratification of norms as per agenda. The Committee decided to defer the case for want of comment of DoP.

Case No. B- 09

M.No.1/AM-17 Date 07.04.2016

M/s. Scitech Specialities Pvt Ltd File No. 01/82/050/00667/AM10 RLA No 03/95/040/00470/AM10 Adv.Auth. No. 0310543476 dated 30.10.2009

Decision: The committee considered this case for amendment the description of export product as per agenda. The Committee decided to amend the description of export product to read as “Cevamune Tablets” as per the earlier decision of NC taken in its meeting No. 01/12 dated 05.04.2011, uploaded at the end of these minutes without any other changes. RA concerned may take further necessary action as per the decision of NC.

Case No. B- 10

M.No.1/AM17 Date 07.04.2016

M/s. Saurav Chemicals Ltd File No. 01/82/050/00865/AM 12 File No. 01/82/050/01382/AM 13 RLA No.22/24/040/00039/AM 12 RLA No.22/24/040/00074/AM 13 Adv Auth No. 2210011843 dated 01.09.2011 Adv Auth No. 2210013689 dated 05.03.2013 Decision: The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/297/2015-PI(Norms) dated 15.03.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No. B- 11

M.No.1/AM-17 Date 07.04.2016

M/s. M/s Shiva Pharmachem Pvt Ltd File No. 01/82/162/00004/AM17 Adv.Auth. No. 3410040849 dated 31.12.2014

Decision: The Committee considered this case for amendment in the description of export product from “2- Methoxy Ethyl Chloride” to “Methoxy Ethyl Chloride” as per agenda. The Committee noted that the firm in their email dated 19.11.2015 stated that the said authorisation was issued by RA on repeat basis as per norms ratified by NC in its meeting No.01/82/2013 dated 4.4.2013 in respect of Adv. Auth.No.3410035547 wherein description of export product is mentioned as “2-Methoxy Ethyl Chloride” as mentioned in the authorisation. While filing of Shipping Bill, description of export item indicates as “Methoxy Ethyl Chloride” instead of “2-Methoxy Ethyl Chloride”. It is noted that firm has not furnished copy of Shipping Bills or any communication from RA in respect of any of the authorisations. Therefore the Committee decided to call for copy of Shipping Bills of both the authorisations and deferred the case.

Case No.B-12

M.No.1/AM-17 Date 07.04.02016

M/s. Camphor & Allied Products Ltd File No. 01/82/050/00623/AM13 RLA No.03/94/040/00363/AM13 Adv.Auth. No. 0310704836 dated.10.08.2012 Decision: The Committee decided to correct the norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/47/2014-Ch-II dated 04.03.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No.B-13

M.No.1/AM-17 M/s. Camphor & Allied Products Ltd File No. 01/82/050/00741/AM13

Date 07.04.2016

RLA No.03/94/040/00222/AM13 Adv.Auth. No. 0310706272 dated.24.08.2012

Decision: The Committee decided to correct the norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/47/2014-Ch-II dated 04.03.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No.B-14

M.No.1/AM-17 Date 07.04.2016

M/s. Camphor & Allied Products Ltd File No. 01/82/050/01071/AM13 RLA No.03/94/040/00543/AM13 Adv.Auth. No. 0310712193dated.09.10.2012

ノ~~ | √ヽ F. No 3 oi 1ts2ot2o1s_pt (Norms) Government of lndia t Ministry of Chemicals & Fertitizers Department of pha rmaceuticals

鏡ざ鷺 :官::ザ,LT牝 . : Office lVtemoranOum subjecr: ;ffil'3ffJ*ffi:,.# Tir;;:' of Hand Book of procedures about request The undersigned is directed to refer to DGFT U.o.No. o1tg2to50/6g2rAM- 16/DEs-3/654 dated tne zgd:jioi?1,;: n'.n'loo',lcation from M/s. sentiss pharma Pvt' Ltd was sent to this o"p,tr"ni for fixation ,;";;;, under para: 4.7for the export of (1) Mydrimax Eye Dro[; ;;i viars (eac; ; containing 8 mg Tropicamide ffil1?"'l},:,1;ffi0,"nt"i. Li' deparrmeni r,rr'"rrrined thI ,rtt-, and fo,owi,s Ｓ ‐ ．ｈ ‐ oescripEon oFEiffi ' product Mydrim@ vials υじ0し′′〃110Jl l ropicarnide 40.80 rlng ,, This issues with the approval of competent authority.. ・ unф [secreねry t04he Gover詰爵。fttia ―― ‐ Phone:- 230t1162 DirectOrate Ceneral of Foreign丁lade, Department Of commerce, (Shtt M.V.Singh,FTDO), UdyOg Bha氏はil,Nevv Delhi 2. C)几

´ ||け千キ1 F. No.350 1 I I 572/2015-PI (Norms) Government of India Ministry of Chemical & Fertilizers Department of Pharmaceuti cals New Dclhi,the Udyog Bhawan. December, 2015 Office Memorandum

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

of M/s RA Chem Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 0ll82l5O!685/AM-16/DES-3/670 dated the 30107115 vide which application from M/s. RA Chem Pharma Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Articaine Hydrochloride. This department has examined the matter and the following norns are furnished under para 4.7 of Hand Book of Procedures (Vol.l) ZO0g-14> S.No. Import Item Qty. Recommended kg/kg. 1 i -Amino-4-Methyl-2-Thiophene Carbxylic Acid Methyl Ester 0.677 2. This issues with the approval of competent authority. (Raj Kumar) Under Secretary to the Government of India Phone:23071162 Dircctorate Gcneral of Forcign Tradc, Dcpartmcnt of Colllllnerce, (Shl・iM.V.Singh,FTDO), Udyog Bhawan,Ncw Delhi

or|+n'lT / lθ Government of lndia Ministry of Chemicals and Fertilizers Department of Chemicals and Petrochemicals

Subject: Advance Authorization application from M/s. Esteem lndustries Pvt. Ltd. for the

import of raw material against the export of Venoxy-HXF (Fatty Alcolhol Polyglycol Etheo. (Advance Authorization No. 1710005809 dated 09.05.2014) Ref : U.O. No. 01 /821050/1 257lAM-1 6/DES -lll I 1 21 5 dated I 5.12.201 5 M/s. Esteem lndustries Pvt. Ltd. has submitted present application for the import of raw material against the export of Venoxy-HXF (Fatty Alcolhol Polyglycol Ether). The application has been examined and the Department recommends the following norms for the present Advance Authorization application. This issue with the approval of competent authority 1 ltem of ExpOrt Qty Item of lmport Qty Venoxy― HXF (Fatty Alcolhol Polyglycol Ether) l kg l Tndecyl Alcohol(lSO T‖ decyl AlcohoD 0 4904 kg 2. Ethylene Oxide 0 5396 kg ぃ蝙・ Addl lndustrial Adviser Tel No 011-23381430 Deptt of C&PC U O No 14010/78/2012-CH― |l dated C■032016

参ゴ F No.35011ノ683/2015-PI(Norms) Government oflndia Ministry of Chemlcal&Fertilizers Department of Pharrnaceuticals ⊆ “ ヽiS Udyog Bhawan, New Delhi, Dated: 21 March, 2016 Office Memorandum

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

Case of M/s lndo Phyto Chemicals Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011638/AM- 16/DES-3/1756 dated the 2t3t16 vide which application from M/s lndo Phyto Chemicals Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Norethisterone Enanthate Bulk Drug. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14.- S.No. lmport ltem Norms Recommended for 1kg Export 3, 3-d imethoxv-5( 1 0)-estrene-'1 7-one intermed iate 0.892kg 2 Under Secretary to the Government oflndia PH:-23071162 Directorate(3eneral of Foreign Trade, Depattment of Commerce, (Shtt M.V.Singh,FTDO), Udyog Bhawan,New Delhi

F. No.350 I 1 14521201 s-Pl (Norms) Government of lndia Department of Pharmaceuticals Dated: 11 APril, 2016 Office Memorandum Case of M/s Hetero Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501510/AM-16/DES- 3t548 dated the 917t15 vide which application from M/s Hetero Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Lamivudine (Purity 99.3%). 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:- Export Product :- Lamivudine (Purity 99.3%) - 1kg 2. This issues with the approval of competent authority' (Rajkumar) Under Secretary to the Government of lndia PH'.- 23071162 Directorate General of Foreign Trade, Department of Commerce, (Shri M.V. Singh, FTDO), Udyog Bhawan, New Delhi S No. lmport ltem Norms Recommended for 1kq Export 1 Lamivudine(Purnv 95%) 1.025kq

，１「 ― 「、 ― ― ゴー F) F. No.3501 1tSO6t2O15_pl (Norms) Government of lndia Department ofpha rmaceutica ls Office Memorandum 1- copy of varid Drug Manuacturing License issued l Controller for each of the pack sizes of g creams, Clotrimazole to be exported. Ⅷ:拠悧押粍

subject: - Fixation :i Tt': under para 4.7 of Hand Book of procedures (vol.l) 2oog-14

Case of M/s Encube Ethicals pvt. Ltd. ' The undersigned is directed to refer to DGFT u.o. No. 01tg2l5ot517lAM- 16/DES-3/611 dated the 15107t15 vide which rppri."ron from M/s Encube Ethicals pvt. Ltd' was sent to this Department for the *p;;;?'] "."r, ( 5 of them based on Miconazole 2% and 4 based on clotrim a,zole ]%f rfis department has exarnined the gXH,il""i;J?i;#'ir%':1"J,[:l?: '' not avairabie in the ipprication;; ;c;il;; by respective State Drug based on Miconazole & ■・Y7甲,V望り19,W9199旦§り即p19, of_each oi the inputs/applied_fOr imp卿 1,fO[ differentTexport products durittg the last 3 years certined by an independent Charfハr●バΔ^ハハ::n+^ハ= 2' copy of Master Batch Formula for each of the export productaduly authenticated by production in-charge of the company. --'r- 3 3|.:5I'::"':1''::'i'1-1'::::l'::-[: ::'oers 3r tubes) or each or the g export s_certified by ah indきp:i言dentとhIIきIL」k:どIiltll:Y二 P19三りotS山亘ng!■1_■yeal nぅ+ぅ _Aハ:,4 ^^` ]
… _ 1・P9,902り19,坤9199旦§り即p191 Chartered Accountant. 2 This issuCS with thc approva1 0f c6m戸 ёient buthO「ity Under secretary to the c"r"rrJ5;l[i'X;? Phone.230T1162 3∂ (Shri MVSingh,FTDO), Udyog Bhawan, New Delhi.

‐ Sub: The undersigned is directed to refer to DGFT U.o. No. oltl2rsorsgorAM-16/DES_3 /334 dated the 021071201s vide which an apprication from M/s J.B. chemicars & Pharmaceuticals Ltd was sent to this Department for fixation or ntrr.lg;si export or Sugar based Medicated Medi-keer A Throat Lozenges. This departmeni has examined the matter and the foflowing norms are furnished under para 4.7 of Hand Book of Procedures (Vol.t) 2009-1 4:- 9′部、|ラ16りの 5 F No 35011/37′ ノ2015-PI(Norms) Government oflndia Ministry Of Chemical&Fertilizers Shastn Bhawan,New Delhi, DatedI March 15,2016 留吾 :‖品 :c』J・JFξ晃 :d unde'と ::予」」号 F)]コ云 ::掃taton of M/s ょ B… chenηに引 s & (Ral KOhar) Under Secretary to the Government oflndia Phone:23071162 Uspi3-Pharma@nrc. in Productto be ExpOrted Descrrprror7 1 1tlaη rrry Raw mate面a:stO bさ:mported Description Quantily in gm bugar DaSed Medicated Medi_ keel A Throat Lozenges 100 lozenges Benzocaine 1.224 gm Cetylpyridinium chloride 0.153 gm mmtthlhe approva Of D rectorlPharma lndlJSt・鵞 3[::羅it讐辮』:冨咆 n予測Q (Sh“ M∨Singh,FTDO), Udyo9 Bhawan,New Delhi

F No.35011/145/2015-PI(Norms) Government ofindia Ministry of Chemical&Fertilizers 午| Dated: 11 APril, 2016 Office Memorandum Subject. - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case of M/s Hetero Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501994/AM- .15/DES-3/1286dated the 413t15 vide which application from M/s Hetero Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Lamivudine. 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:- Export Product :- Lamivudine - 1kg 2. (Ralkumar) Under Secretary to the Government oflndia PH:… 23071162 Directorate(3eneral of Foreign Trade, (Sh画M・∨・Singh,FttDO), S.No lmpoft ltem 1kq Export 駆 i黒∫脚り軍 `枷需さ紀 :よ糧'墨 1 10kg

F. No.350 11 11951201 5-Pl (Norms) Government of lndia Dated: 1'1 APril, 2016 Office Memorandum Case of M/s Hetero Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501793/AM-1S/DES- 3t1424dated the 12t3t15 vide which application from M/s Hetero Labs Ltd. was sent to this Department for fixation of norms under para'. 4.7 for the export of Nevirapine. 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:- Export Product:- Nevirapine - 1kg 2. (Ralkumar) Under Secretary to the Government oflndia PH:… 23071162 S.No lmpoft ltem 1kq Export 1 :諦露;ザ」 :長明雅鼎 `蝋 ∈張 .1 ツ 1・ 10kg

otf ra"'t -11 s{ F. No.350 1 1 16241201 5-Pl (Norms) Government of lndia Dated: 21 March, 2016 Office Memorandum Case of M/s Granules lndia Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501664/AM-16/DES- 31807 dated lhe 2018115 vide which application from M/s Granules lndia Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Compresso Cotrim 90 (sulfamethoxazole and trimethoprim granules DC). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14.- S.No. lmport ltem Norms Recommended for 1kq Export 1 sulfamethoxazole 0.750kq 2 Trimethoprim 0.150kq 3 Preqelatinised starch 0.043kg 4 Croscarmellose sodium 0.040kg 5 Pov:done K-30 0.006kq 6 Sodium lauryl sulfate 0.001kg 7 Stearic acid 0.010kq 2. PH.- 23071162

F. N0.3501 1138312015-Pl (Norms) Government of lndia Department of Pharmaceutlcals Shast‖ Bhawan,New Delhi, Dated:March 171 2016 Office Memorandum Sub: - Fixation of norms under para 4.7- Application of M/s J.B. Chemicals & Pharmaceuticals Ltd. The undersigned is directed to referto DGFT U.O. No. 011821501279/AM-16/DES-3/447dated the OZtO7t2015 vide which an application from M/s J.B. Chemicals & Pharmaceuticals Ltd. was sent to this Department for fixation of norms against export of (i) Difflam Raspberry Sugar Free Lozenges , (ii) Difflam Eucalyptus & Menthol Sugar Free Lozenges, (iii) Difflam Honey & Lemon Sugar Free Lozenges, (iv) Difflam Orange Sugar Free Lozenges and (v) Difflam Sugar Free Double Mint Lozenges. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14.- Product to be Exported Raw materials to be lmported S IVο Description Quantity Description Qυ aη″ly加 gm Difflam Ra'pberry Sugar Free Lozenges 100 lozenges Benzydami ne Hydrochloride 0.306 Cetylpyridinium Chloride 0.135 lsomaI ST―M 258.460 Custard Flavour 52940 A 0.520 Raspberry Flavour 580004 A 0.520 2. Difflam Eucalyptus & Menthol Sugar Free Lozenges 100 lozenges Benzydamine hydrochloride 0.306 Cetvlpv百dinium Chloride 0.135 lsomaL ST―M 258.600 3. Difflam Honey & Lemon Sugar Free Lozenges 100 lozenges Benzvdami ne Hvdrochloride 0.306 Cetvlpv百dinlum Chlo百de 0.135 lsomalt ST― M 258.300 Flavour Lemon Tetramone 100 % 0.520 Honev Flavour 503666 A 0.075 4. Difflam Orange Sugar Free Lozenges 100 lozenges Benzvdamine hvdrochloride 0.306 Cetylpv百dinium Chlo百de 0.135 lsoman ST―M 258.100 Oranqe Flavour 51239 A 0,780 5 Difflam Sugar Free Double Mint Lozenges 100 lozenges Benzvdamine hvdrochloride 0.306 Cetvlpvttdinium Chloride 0.135 lsomal ST―M 259.186 Flavour Aromalc 52503丁 0.312 2. This issues with the approval of Director (Pharma lndustry). Phone. 23071162 Uspi3-Pharma@nic.in Department of COmmerce, (Sh百M V Singh,FttPO), Udyog Bhawan,New Delhl イナの“ ″ )■ 弥/`Q

atl* F. No.350 1 | 125612015-PI (Nlorms) Government of India Ministry of Chemicals & Fertilizers Udyog Bhawan,New Delhi, Dated the October, 20i5 Office Memorandum

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

of M/s Auctus Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011288/AM-151DES-3127 dated the 0ll05ll5 vide which application from M/s. Auctus Pharma Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Rifaximin. This department has examined the matter and the following norrns are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009 -1 4:- S. No. Import Item Qty. Recommended kg/kg. 1 Rifamysin-O t.52 (Barnali Khastgir) Phone:23071162

2 F.No.35011/395/2015-PI(Norms) Government oflndia Ministry of Chemical&Fertilizers Shastri Bhawan, New Delhi, Dated. March 15, 2016 Office Memorandum Sub: - Fixation of norms under para 4.7- Application of M/s J.B. Chemicals & Pharmaceuticals Ltd. The undersigned is directed to refer to DGFT U.O. No. 011821501278/AM-16/DES-3 /410 dated the 0710712015 vide which an application from M/s J.B. Chemicals & Pharmaceuticals Ltd was sent to this Depaftment for fixation of norms against export of Medi-kee! A Throat Sugar based Medicated Lozenges. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-1 4:- Phone:23071162 Uspi3-Pharma@nic.in Depanment Of Commercel (Shtt M∨Singh,FttDO), Udyog Bhawan,New Delhi. Product to be Exported Raw materials to be lmported Description Qυaη″ly Description Qυ aη `′ fyわ mg/rOzenge Medi-keel A Throat Sugar based Medicated Lozenges. 1 lozenge Benzocaine 12.24 rng Cetylpyridinium chloride 1.53 rng . This issues with the approval of Director (Pharma lndustry). ―_

I'n^-,> 51ヽい。｀9ξ Office Memorandum sub: _ Fixation of norms under v;;:i-.?- Application of M/s J.B. chemicals & Pharmaceuticals Ltd' The undersigned is directed to refer to DGFT U.o. No. 01l,2lsol4.g/AM-16/DEs-3 /407 dated the ottotizdli- vide *rricr,- an application- from M/s J'B' chemicals & pharmaceuticars Ltd. was sent to tnis oepartmLnt for.fixation of norms against export of Difflam AAA Sugar Free Lozenges-i" di""x"urranuHoney & Lemon/Eucalyptus and Menthor Fravours. This department rras examined the matter and the foilowing norms are furnishedunderpatra4.TofHandBookofProcedures(Vol.l)2009-14- F. No.3501 1t3gOt2O15-Pl (Norms) Government of lndia Depariment of Pharmaceuticals 2. ThisissueswiththeapprovalofDirector(Pharmalndustry). shastri BhaWan,New Delhl, Dated:March 17,2016 (Rai Kumar) Under Secretary tO the Government oflndia PhOnei 23071162 Us仰3-Pharma@niC・in Directorate(3enera1 0f Foreign ttrade, 障∬∬響蘇 i 市ported Product to be ExPorted 100 1ozenges Difflam~AAA Sugar Lozenges BlackcurranUHoneY Lemon/EucalYPtus Menthol Flavours ｅｅｉｎ＆ｎｄＦｒ　　　ａ lsomalt ST-M

F. No.3501 1 138312015-Pl (Norms) Government of lndia 例ナ仲‐ l・ト Shastri Bhawan,New Delhi, Dated:March 17,2016 Office Memorandum Sub: - Fixation of norms under para 4.7- Application of M/s J.B. Chemicals & Pharmaceuticals Ltd. The undersigned is directed to refer to DGFT U.O. No. 0118215014241AM-16/DES-3 /426 dated the 07lO7l2O15 vide which an application from M/s J.B. Chemicals & pharmaceuticals Ltd. was sent to this Department for fixation of norms against export of (1) Difflam Sugar Free Lozenges in Raspberry/ Eucalyptus & Menthol/Honey & Lemon/ ,Orange/ Double Mint flavours (2) Andolex Lozenges Sugar Free Mint. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14- Product to be ExPorted Raw materials to be lmported S N0 Description QuantitY Description Quantity in gm Difflam Sugar Free Lozenges in Raspberry/ Eucatyptus & Menthol/Honey & Lemon/ ,Orange/ Double Mint flavours 100 1ozenges Benzydamine hydrochloride 0.306 lsomalt ST― M 257 Cetylpyttdinium Chlo百de Not needed as per DML 2. Andolex Lozenges Sugar Free Mint 100 1ozenges Benzydamine hydrochloride 0.306 lsomalt S丁―M 258.60 2. This issues with the approval of Director (Pharma lndustry). (Raj Kumar) Phone: 23071162 Uspi3-Pharma@nic.in Directorate(3eneral of Foreign Tradel Department of Commerce】 (Shtt M V Singh,FTDO),

F. No.3501 1 /43012015-Pl (Norms) Government of lndia Dated: 29 March,2016 Office Memorandum Case of M/s Mehta API Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215014731AM-16/DES- 3/506 dated lhe 8llt15 vide which application from M/s Mehta API Pvt. Ltd was sent to this Department for fixation of norrhs under para: 4 7 for the export of Azithromycin/Azithromycin Dihydrate EP/BP/USP. This department has examined the mattei and the following noims are furnished under para 4.7 of Hand Bciok of Procedures (Vol.l) 2009-1 4:- つ４ alil′ 卜、 92 ∪nder Secretary to the Government ofindia PH■23071162 Directorate General of Fore19n Trade, Depanment Of CommerCe, (Shn M∨Singh,FTDO), Udyo9 Bhawan,New Delhi S No 1 lmport item 1kq Export Azithromycin Amine havinq purity NMT 94% 1 07kg

o, I t1 S. bto- t I F. No.3501 1 138312015-Pt (Norms) Government of lndia Shastri Bhawan, New Delhi, Dated: March 17,201G Office Memorandum Sub: - Fixation of norms under para 4.7- Application of M/s J.B. Chemicals & Pharmaceuticals Ltd. The undersigned is directed to refer to DGFT U.O. No. O1tB2tSOt423lAM-16/DES-3 /440 dated the 0710712015 vide which an application from M/s J.B. Chemicals & Pharmaceuticals Ltd. was sent to this Department for fixation of norms against export of Difflam Black Currant Sugar Free Lozenges . This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14- 2. This issues with the approval of Director (Pharma lndustry). Phone: 23071162 Uspi3-Pharma@nic.in (Shri MVSingh, FTDO), Product to be Exported Raw materials to be lmported Description Quantity Description Quantity Difflam Black Currant Sugar Free Lozenges 100 lozenges Benzydamine hydrochloride 0.235 gm Cetylpyridi nium Ch loride Not needed as per DML lsomalt ST―M 257.397 gm

芦・，ｔＯ F. No.350 l 1 13651201 5-PI (Norrns) Govemment of India Deparlment of Phanlaceutical s Udyog Bhawan, New Delhi, the ff Noveniber, 2015 Office Memorandum

Subject: - Fixation of norms uncler para 4.7 of Hand Book of procedures (Vol.l)

2009-14 Case of M/s Sun pharma Industries Ltd. The undersignecl is directed to refer to DGFT U.o.No. ollg2l50ll57lAM- l6IDES-31314 dated the 02107115 vide which application fro6 M/s. Sr-rn pha,ra Irrdustries Ltd was sent to this Depaftrnent for frxation of norrns uncler para: 4.7 fo[ the export of Valacyclovir/Valaciclovir Hydrochlorir]e Tablets/Capsules. Tliis depatlmetlt has examined the matter and the followipg norms are fur,ishecl under paru 4.7 of Ifa,d Book of procedures (vol.l) 2oog-ru;- S. No. Impolt Itent Qty. Recouimended. ] Valacyclvoir i{cl BP/USP 556mg/500rrg rabler & 1 1 l2n'tgl l00Omg tabler つん (Rai l(r-rmar') Under Secretary to the Governntent of Inclia Pho ne:2307 I l6? Directorate General ol' Foreign Tracle, Departurent of Coultrerce, (Shri M.V. Singh, F1'DO), Udyog Bhau,an, Neu, Delhi

Sub: F. No.350 11 t37 1 1201 5-Pl (Norms) Government of lndia Office Memorandum Fixationofnormsunderpara4.T-Application Pharmaceuticals Ltd. ″ソ |:t7 Shasttt Bhawan,New Delhi, Datedi March 16,2016 of M/S JB.ChemiCalS & Under Secretary tO the Government oflndia PhOne:23071162 Usp13-Pharma@niC・in The undersigned is directed to refer to DGFT U.o. No. 01l,zlsots'./AM-16/DES-3 /335 dated the O2lO7l2O15 vide wtrictr- an application from M/s J'B' Chemicals & pharmaceuticars Ltd. was sent to tN. o"prrtment for fixation of norms against export of Difflam Lozenges Mint Fresn ftavou, brg", Free and Andolex-C Lozenges Sugar Free Fravour. ttrrs Jepartment has examined the matter and the foilowing norms are 「 Iじじ :laV υul・ ::‖ ツ VVドい… '・・~… ‐ ―― 〕dureS(∨01.|)2009-14:― furnished under para 4.7 of Hand BoOk Of ProC( Directorate(3enera1 0f Foreign Trade, Department of COmmerce, (Shtt M V Singh,FTDO), Udyog Bhawan,New Delhi_ productto be E】ported Raw materials to ne lmPorted 話 S.rVo I DescriPtion I @ I Fresh Sugar j I Free Lozenges I I 2. I Andolec-C I Lozenges Sugar I Free Qυ an″ケ DescriPtion Qυ anf′ryわgm 100 lozenges 100 lozenges Benzydamine hydrochloride 0.306 lsomatt S丁―M 259。48 Benzydamine hydrochloride 0.306 lsomatt ST― M 258.60 Cetylpyridinium Chloride 0.135 lopromide 52.368 2~~~丁雨了蔭頭更悪雨面th the approvalЮ f―Directo「(PharmaJndu stry). -(Ri

,tlan-rT lι 0 Government of lndia Department of Chemicals and Petrochemicals

Subject:-Advance Authorization application from M/s. Nocil Pvt. Ltd. for the import of raw

material against the export of N-(Cyclohexylthio) Phthalimide (PILGARD PVI) (Advance Authorization No. 0310794587 dated 16.3.1 5 Ref: U.O. No. O3l95lO40l00974lAM 15 dated 12.2.15 M/s. Nocil P!,1. Ltd. have submitted present applications for the import of raw material against the export of N-(Cyclohexylthio) Phthalimide (PILGARD PVI). The application have been examined based on the addition information furnish by the firm. The Department recommends the following norms for the present Advance Authorization application. Item of Export Qtv Item of lmport Qty N―(CyclohexyLhio) Phtha‖mide(PiLGARD PVI) l kg 1 Phthalic Anhydride(PA) 0 617 kg 2. Dicyclohexyl Disulphide(DCDS) 0 485 kg 2 CauStic Potash Flakes 0 233 kg シ ´ い聰 AddI lndustrial Adviser Tel No 011-23381430 Deptt Of C&PC U O No 14010/32/2012-CH― ll dated 032016

グ′″リケ I t'>- F. No.3501 1 /6451201 s-Pl (Norms) Government of lndia Dated: 21 March,2016 Office Memorandum Case of M/s Yeluri Formulations Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01l82l50lB02lAM-16/DES- 3/899 dated the 8/9/15 vide which application from M/s Yeluri Formulations Pvt. Ltd. was sent to this Department for fixation of norms under para'. 4.7 for the export of Amoxicillin & Clavulanate Potassium Tablets USP 625m9. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S No lmport ltem For ExpOrt ofl No Tablet 625mq 1000mg 1 Amoxic‖ lin丁nhydrate USP 585 36mg 1024 38mg 2 Potassium Clavulanate Diluted USP 127 563mg activity 127 563mg activity 2 (Raijkumar) Under Secretary to the Government oflndia PH: 23071162 Depanment Of Commerce, (shn M v singh,FTDO),

F. No.350'1 1i41312015-Pl (Norms) Government of lndia Daled:22 March, 2016 Office Memorandum Case of M/s CTX Life Science Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. O1t82t5Ol545lAM-16/DES- 3/328 dated the2l7115 vide which application from M/s CTX Lifescience Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Oxcarbazepine. 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:- ヽ S.No. lmport ltem Norms Recommended for 1 kq Export 1. 1 0- methoxv iminostilbene 1.26ks う乙 PH- 23071162 lLe:

o)l}A]-r 1´ Government of lndia Department of Chemicals and petrochemicals

subject: Advance Authorization application from M/s. Ruchi soya lndustries Ltd. for the

import of raw material against the export of Soya Lecithin Liquid (Food Grade). Ref: DGFT U.O. No. 01t82ts0t16gt AM- 16/DES-ily145(i) dated 17.06.211|s M/s. Ruchi Soya lndustries Ltd.. have submitted present application for the import of raw material against the export of Soya Lecithin Liquid (Food Grade). The application has been examined and the Department recommends the following norms for the present Advance Authorization application. (A K AGARWAL) Addl lndustrial Adviser Tel No 011-23381430 Shn Mahender Vikram Singh,FTDO,(DES■ll)○ノo DGFT,Udyoq Bhawan,New Delhi-11 Deptt of C&PC U tt No 14010/31/2015-CH― ll dated 04 03 2016 1 !tem of Export Qty Item of lmport Qty Soya Lecithin Liquid (Food Grade). Technical Specification: i) Moisture - 1% Maximum ii) Color - 60 unit Maximum (lCV) iii) Viscosity at 25oc - 120 Poise Maximum iv) Peroxide Value - 3 Meq/ kg Maximum l kg l.Crude Soya Lecithin Liquid rechrca!-Spcsfleeiie!. i) Moisture - 2% Maximum ii) Color - 80 unit Maximum (lCV) iii) Viscosity at 25oc - 130 Poise Maximum 1 00 kg 2.Soya Fatty Acid 0 010 kg 3. Hydrogen Peroxide 0 002 kg ヽ

PH'.- 23071162 F. No.3501 1/61 7 12015-Pl (Norms) Government of lndia Dated: 21 March,2016 Office Memorandum Case of M/s Globe Trott€rs Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501737IAM-16/DES- 3/811 dated lhe 20l\l15 vide which application from M/s Globe Trotters Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Rifampicin syrup/suspension. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14i DGFT is advised to call following details from the firm viz:- 1 . Size fo the bottles to be exported/volume of syrup. 2. Copy of master-batch formula duly certified by Q.C. incharge. 2.

ヘ I:. Ntl,"i5(l l I,'660r'10 l 5-PI (Norms) Crt'ernlncnl of'India i\l in isrr.r. ol' C'hcnr icals & lrerti lizers I )cpa rlrnent ol' Irharmaceuticals t'dyog Bhawan、Nc、vl)clhi. I)(licd: 12「じ卜ru〔l、.201() omcc Mc,1。1■nJulp ｀uliCCt:‐ 1'i、ati()n ofn゛自1lS undcr para 4.7()flland 3ook t)1｀Proccdurs(v()|.|)2009_14 (losc()1｀、4/sP()1・ti、 l′ ahS I)、`t.1.td. 1‐ hc ti1ldet・siglled i、dircctcd to:でibr10 1)GFl・ tl,0.ヽ0.o1/82150/871「Aヽ1‐ 16■)LS‐ 1ヽ/900d〔ttcd thc 8/9/15、1(lc、、hich applicati゛:1 lr()111｀4/sP()rti、 1.ab、Pvt,Lttl.、、as、cnt t()thi、 1)epattnlcnt k)r il、 atiOn o:｀ nく、mls undcr para:4.7 1iDr thc c、pOH()|｀SMKl:(S,‐ 卜1{||‐ 13‐ 12(E,‐ (7‐ chl●r02tllli1lolin)l,ctilcil)llPhCn〉 |||_312‐ (l‐ 1lydrO、y‐ 1-inethyl ctilyl)Phenyl]^l‐ propa1101.l his dcpa:■ 1110:lt haヽcxa11lincd thc 11lattcr and thc fb‖ ()、、′ ing nOrnls arc illrnishcd ヒ :1ldcr p(lra 4.7()f卜land i〕 (ヽok()1｀Pr()ccdtirc、(ヽ「011)2009_14:‐ vrc llla)′ thcrcfk)「c iltlマ)rill DGFl lllat 60th i111,o!・ 1モindぜ、P()rt prc)dticts ttic onc and tilぜ、ぉnc ttanにJ cttnpOmd、胡dttc nm ha、n d hn hmATdぃ Sup口た「md ttc c、Юtt POdua t… nc m御Ⅷねduttn3 0∝i宙い hЮ 卜cd. N(｀1ll(1)takc a ri111:l vic、、 . 2. l hi、issues、vith t1lc approval()i｀ cく、 ini,ctent at:th()rity. (R〔liktl!11〔ll・) tilldcr Sccrctary t()thc(1()vcrnillcntにヽ1 1ndia Phone:23('71162 [)irectoratc(lcncral()|｀「ぃ「ぜign Tradc. Dcp〔trilllclit Of〔・ ollnillcitc、 (｀hri M.V.Singh、「 ‖)()) 【 jd)'()彗13hawain、Nc、vI)clhi

F. No.350111682t2015-Pl (Norms) I ) I Government of lndia Dated: 22 March,2016 Office Memorandum

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

Case of M/s RA Ghem Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 01lBZl50l838/AM-16/DES- 3lg3zdated the 9/9/15 vide which application from M/s RA Chem Pharma Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Diflunisal. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S.No. lmport ltem Norms Recommended for 1kq Export 1 2,4-Difluoro Biphenyl 1.64kg 2 Methylene Dichloride 1.47kq 3 Maleic Anhvd面de 3.44ks 4 lsopropyl alcohol 0.31ks 5 Methanol 0.97kg 6 N, N-Dimethyl Acetamide 0.43kg 7 Chloroform 1.39ks 8 Ethyl Acetate 0.77lkq 2. This issues with the approva1 0f competent authority PH- 23071162 (Rajkumar) (

F. No.350 | I 1657 12015-PI (Norrns) Government of India Dated: l2 February, 2016 Office Memorandum Case of M/s Morepen Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501841/AM-16/DES- 3/855 dated the ll9l15 vide which application from M/s. Morepen Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Sitagliptin Phosphate Monohydrate. This department has examined the matter and DGFT is advised to call following details from the firm viz:- Complete and balanced chemical reactions especially step-l alongwith mol. wt. of each reactant their moler requirement. %o yield on molar basis for each step. Past production vis-a-vis actual consumption of all imported inputs duly certified by Central Excise Authorities. (Rajkumar) Department of Commerce. 4. ５６

ot) n S t'lo. lttl F. No.3501 1/679/201 5-Pl (Norms) Government of lndia Dated: 21 March,2016 Office Memorandum Case of M/s United Biotech Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01l82l50l8B6lAM-16/DES- 3/904 dated the 8/9/15 vide which application from M/s United Biotech Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Ticarcillin & Glavulanic Acid for lnjection USP 3.29m Ticarnic 3.29m. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S.No. lmport ltem Norms Recommended 1 Ticarcillin Disodium and Potassium Clavulanate 1 5:1 Raw Pharmaceutical lngreident 3.369m/3.29m vial 2 PH:- 23071162

+- xr0 F. No.350 l 1 1267 12015-PI (Norms) Government of India Ministry of Chemicals & Fertilizers Department of Pharmaceutical s Udyog Bhawan,New Delhi' Dated the October, 2015 Office Memorandum

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

of M/s Smilax Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 0ll82l50ll17lAM-L61DE'S-3/18 dated the 11106115 vide which application from M/s. Smilax Labs Ltd was sent to this Department for fixation of norms ,rnd". para: 4.7 for the export of (R)-3-(Tert-Butyl Dimethyl Sitytoxy)-pentane-Dioic Acid Monotert-Butyl Ester (TB-17) Tert-Butyl 3R-Tert-Butyl Dimethyl Sityloxy-Glutarate. 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:' (Bamali Khastgir) Phone:23071162 S. No. Import Item Qty. Recommended kg/kg. 1 D irnethyl-3 -Hydroxy G lutarate 1.106 つ４ Ditertbutyl Dicarbonate 1.564 り， Iertiary Butyl Dirnethyl Silyl Chloride 2.136 4. lmidazole 1.319 ５．一６． R-Phenylethyl Arnine 0.480 Tertiary Butanol つ，

F. No.350 1 1 /6621201 s-Pl (Norms) Government of lndia Dated: 21 March, 2016 Office Memorandum

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

Case of M/s Jodas Expoim Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215018501AM-16/DES- 3/889 dated the 3/9/15 vide which application from M/s Jodas Expoim Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Cefoperezone & sulabactum for injection 1gm. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14'.- DGFT is advised to call copy of the DML from the firm alongwith COA of the imported item from the foreign supplier l ~~ 2 PH- 23071162

びIAジ lらレ Shastri Bhawan, New Delhi, Dated. March 15,2016 Office Memorandum Sub: - Fixation of norms under para +.2- Apptication of tvt/s Unijules Life Sciences Ltd. The undersigned is directed to refer to DGFT U.o. No. 01tg2tsotoogog/AM-16/DES-3 i926 dated the 09/0912015 vide which an application from M/s Unijules Life Sciences Ltd. Nagpur was sent to this Department for fixation of norms against export of lopromide lnje-ction 300 mg lodine/ ml and lopromide lnjection 3zo nig lodinei ml in S0 ml, 100 ml & 200 ml vials and lopromide tnjection 24ti mg lodine/ ri-tn 50 ml & 100 mt packs. This department has examined the matter and the following norms are furnished under

para 4.7 of Hand Book of procedures (Vol.l) 2OOg_14._

F.No 35011/622/2015-PI(Norms) Government oflndia Ministry of chemical&Fertilizers Department of PharrTlaceuticals (Raj Kttfal) Under Secretary to the(3overnment oflndia Phone: 23071162 Uspi3-Pharma@nic.in (Shri MVSingh,FTDO), Udyog Bhawan, New Delhi. Product to be Exported Raw materials to be lmported S IVο Description PacたSレθ Description Qυ anrlilyわgm/ylia′ lopromide lnjection 300 mg lodine/ ml 50 rnl lopromide 32.728 100 rni lopromide 65.457 200 rnl lopromide 130.914 2 lopromide lnjection 370 mg lodine/ ml 50 rnl lopromide 40.365 100 rnl lopromide 80.730 200 rnl lopromide 161.460 3. lopromide lnjection 240 mg lodine/ ml 50 rnl lopromide 26.184 100 rnl lopromide 52.368 . This issues with the approval of Director (pharma lndustry). ]・ハ′ uma

clf n.-t.t- l6{ F. No.3501 1 /6651201 s-Pl (Norms) Government of lndia Dated: 21 March, 2016 Office Memorandum Case of M/s Zeiss Pharmaceuticals Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215018661AM-16/DES- 31912 daled the 8/9/15 vide which application from M/s Zeiss Pharmaceuticals P,rt. Ltd. was sent to this Department for fixation of norms under paru 4.7 for the export of Santron 1.0 G (Each Vial contain Aztreonam Sterile Powder 1.8649m). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S.No. lmport ltem Norms Recommended for 1 kq Export 1 Aztreonam Sterile Powder for lniection USP '1 .864qm/vial 2 PH:- 23071162

Dated: 21 March, 2016 Office Memorandum

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

Case of M/s Jubilant Life Sciences Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215018511AM-16/DES- 3/890 dated the 3/0/15 vide which application from M/s Jubilant Life Sciences Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export- of Zinc pyrithone sO"/ FpS. This department has examined the matter and the following norrr "r" furnished under para 4.7 of Hand Book of Procedures (vol.l) 2009-14:- The firm has applied import of Zinc Pyrithone on net to net basis i.e. 0.50k9 per kg of export. Norms committee may take a final view in consultation with deptt. of chemical & Petrochemicals also. F. No. 350 1 1 /667 12015-Pl (Norms) Government of lndia 2. This issues with the approval of competent authority' lrnder secretary to the "*"ffi-"!iSilit;

F. No.3501 1/659/201 s-Pl (Norms) Government of lndia Dated: 21 March' 2016 Office Memorandum Case of M/s Jagsonpal Pharmaceuticals Ltd' The undersigned is directed to refer to DGFT U.O.No. 01l'2l50l853lAM-16/DES- 3/865 dated the 2tgt15 vide which application from M/s Jagsonpal Pharmaceuticals Ltd was sent to this Department for fixation of norms under parc: 4.7 for the export of tttifepristone Tableis 200mg. This department ha.s examined the matter and the ioiroriring norms are furnished-under para 4.7 of Hand Book of Procedures (Vol l) 2009- 14.- DGFT is advised to call following details from the firm viz:-

COA of imported misoprostol dispersion from the foreign supplier'

This issues with the approval of competent authority' (Ralkumar) Under Secretary to the Government oflndia PH:-23071162 Directorate General of Fore19n Trade, Depattment of COmmerce, (Shn M∨Singh,FTDO),

F No 35011t511t201S_pt (Nornrs) Government of lndia '-/ Ministry of Chenrical & Fertilizers Deparinrent of pharrlaceLr ticals Shastri Bha,,^yan. Nevrr Delhi, Datecl Decentber SO ZOli ellLce_!lertar_alfur sLrbject - Frxation of trortlls tttrcler para 4 7 of Harcr Book,f pr-ocecrures (Vor r)2oog-14 Case of |,rlls 7lM Laltoratories Ltcl The unclersignecl is clrrectecj to refer to DGFT U.O No 01/g2lSO|T16/AIV_ 16/DES 3/688 ciateci tl-te 31loi/is ui,ru rn,crrlpp]i.""t)on fronr l\rrls ZIM Laboratories Ltcl rrras se't to this Depari,rert for frxarron or nol,.,rr''irncrer p"rrr ;;, ;, the export of fij[:fl,1i#,3;#?j :H#mr,im,"..jHxr:# !:: m:1,,..1r,]: , sttei an. the [r c-rr-rt ihe applrcant -

ttt t' rs d*-(rrr(:alloll arrlr u'.ii i iray caii for tnu,rr"u $"Jiii::'11i:,i,x:n :;:; ;iilT:bottre/anrpo'l 'Ie or other conra ner or the label. by the-st.t" DrLrg controil",]t" normally approvecl alongwrth 2 This issues r,,rzith the approval of competent auihonty Uncier Sec.etai-y- r.o rire "orurnnl3;i5rT;3 phone 23C71162 Department of Conrmerce. (Shri M_V Singh, FTDO), Udycg Ehawan. New Delhi.

´1´ 松‐ N7 雨 F. No.3501 1 /6901201 s-Pl (Norms) Government of lndia Dated: 21 March, 20't6 Office Memorandum Case of M/s Alphamed Formulations Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182150181914M-16/DES- 3/1005 dated the 27110115 vide which application from M/s Alphamed Formulations Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Guronsan C Effervescent Tablets. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14.- DGFT is advised to call copy of master-Batch formula from the firm duly certified by Q.C. lncharge. 2. PH:- 23071162

or lA4-tv F. No.350 1 I I 1 6612013-PI (Irlorms) Government of India tr{ Udyog Bhawan, New Delhi, the 09th May,ZOl3 Office Memorandum

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

of M/s. Granules India Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501948/AMl3/DES- 311047 dated the 06112112 vide which an application from M/s. Granules India Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Compresso CIP 65. This department has examined the matter and the following comments are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- つ４ This issues with the approval of Director (Cost). Under Secretary, (Raj Kumar) to the Government of India PI-Norms (Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi' S. No. Import Item Qty. Recommended kg/kg. l iprofloxacin Hcl 0.757 2. Maize Starch 0.159 3. Sodium Starch Glycollate 0.040 4. Povidone K-30 0.005 くリ Pregalatinised Starch 0.025 6. Magnesium Stearate 0.009 7. Silica Colloidal Anhydrous 0.005

No.46011/22/2008¨ PC.H Govemment oflndia Ministry ofChemicals`とFertHizers Department ofChemicals&Petrochemicals …2ケ Room No.223, A Wing, Shastri Bhawan, New Delhi-l l0 001 Dated the 5th April,2016 --1-, OFFICE MEMORANDUM Sub: Application from M/s. Pregna International Ltd. for the import of raw material against the export of Intra Uterine Contraceptive - Copper T 380 A for issue of advance licence (DGFT Ref. No. 01182/050l0ll42lNl-l6tDES-IIVl240 dated 10.12.2015) - reg The undersigned is directed to refer to DGFT U.O. No. 011821050101142/M-16/DES- Illl1240 dated 10.12.2015 forwarded an application for issue of advance licence from M/s. Pregna International Ltd. for the import of rarv rnaterial against the export of Intra Uterine Contraceptive - Copper T 380 A for issue of advance licence (Licence No. NOT GIVEN). The application has been examined in Department of Chemicals and Petrochemicals and the following norms are recommended for the reference licence application:- Joint lndustrial Adviser Tel:011… 23071442 Telefax:011-23071187 Emai1l ol■shamlaのnic.in Name of Export ltem(s) Qty in Nos. Name of import Item(s) Qty.in kg Intra Uterine Contraceptive Copper T 380 A l No. Copper wire with (99.99% purity) 0.000204 Granules (moulding grade) 0.0012 Pouches (plastics) Nct+10% Copper Tube(99.99° /o purity) 0.000169 Polypropylene Granules 0.0015543 Compound of LDPE resin &, barium sulphate 0.000415 PVC granules 0.000658 HDPE Granules (or nylon resin) medical grade 0.000177 This has approval of the competent authority. Shri Mahender Vikaram Singh, Foreign Trade Development Officer, Ministry of Commerce and Industry, Fax: 2306 2225 123061613

F. No.3501 I 1317 12015-PI (Norms) Government of India Department of Pharmaceutical s Ncw Dclhi,the Udyog Bhawan, November,20l5 Offlcc NIlemorandum SutteCt:― Fixation of norms undCr para 4.7 of Hand B00k of Procedures(VOl・ 1)2009-14 Case of Ⅳ1/s Venus Rernedies Ltd. Thc undersigned is directed to refer to DGFT U.O.No.01/82/50/123/AⅣ l-16/DES-3/10 datcd thc l1/06/15 vidc which application from M/s.Venus RcFnCdiCs Ltd was sellt to thiS 器側鼎篤悧朧富∬謡 ξ鳳酔脚ぶ織盤 T淋ぶ )1.1)2009-14:― (Rtt Kumar) Under Secretary to the Govcrnmcnt oflndia PhOnc:23071162 (Shri M.V. Singh, FTDO)' 157.5mg/1 5nll And 472.5mg/45nll Import Item

F. No.350 11 16881201 s-Pl (Norms) Government of lndia Dated: 29 March,2016 Office Memorandum Subject. - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s Aktinos Healthcare Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. O1t82l50l929lAM-16/DES- 3t11z4 dated tne ian0/15 vide which application from M/s Aktinos Healthcare Pvt. Ltd. was sent to this Department for fixation of norms under para: 4-7 for the export of (1R,2S)-1-phenyt-2-(t-pyrrolidinyl)-1-propanol. This department has examined the matter and the following norms are'fuinished under para 4.7 of Hand Book of Procedures (Vol. l) 2009-1 4'.- S.No. 1 lmport item 1kq Export Propiophenone 3.21k9 2 Pvrrolidine 1.90k9 3 Sodium Borohydride 0.77k9 4 Zinc Chloride 0.80k9 5 L-(+)-Tartaric Acid 2.419k9 6 D-(-)-Tartaric Acid 0.775k9 2 This issues with the approval of competent authority' PH- 23071162

c,tln.,4-tv dLv ぃ鼈い Addl lndustrial Adviser Tel No 011-23381430 / Government of lndia Department of Chemicals and Petrochemicals

subject: Advance Authorization application from M/s. Esteem lndustries Pvt. Ltd. for the

import of raw material against the export of Glycerin Ester (Advance Authorization No. 1710006170 dated 04.9.2015) Ref: U.O. No. 01/821050/1277lAM-16/DES-|ll/1310 dated 16 12 2015 M/S.EsteemlndustriesPvt.Ltd'hassubmittedpresentapplicationfortheimport of raw material against the export of Glycerin Ester TheapplicationhasbeenexaminedandtheDepartmentrecommendsthe following norms for the present Advance Authorization application' This issue with the approval of competent authority.

ltem of Export Qty Item of lmport Qty Glycerin Ester l kg 1 . Ethylene Oxide 0 6483 kg 2 Stearic Acid 0 2790 kg Deptt of C&PC U O No 14010/78/2012-CH■ l datedキ032016

.- t !/4"4-t) (!t' I-;<- F. No.3501 1 /72412015-Pl (Norms) Government of lndia Dated: 04 April, 2016 Office Memorandum Case of M/s Kopran Research Laboratories Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182150198914M-16/DES- 311127 daled lhe 26111/15 vide which application from M/s Kopran Research Laboratories Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Azithromycin dihydrate. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14- S.No. lmport item 1 kq Export 1 Azithromycin amine 1.00kq 2 Acetone 0.90kq 2 PH- 23071162

4 「.No.35(111/175/2015-PI(ヽ ()1・nls, (1()vcrnil〕cllt ol｀India ヽlinistl・、o「C1lc:1lical、&IIcl.tili/cr、 |)cI)a:・t nlぜnt(Drl)llarntacetllic〔11、 ′ 一27` 1ldyos Bllawtin.ヽじ、、1)clhi、 1)ated thc Scptenlhcr.2015 (〕Ficcヽlclll()randunl SuhieCt:-lli、ation t)「:10rllls tindCr ptill1 4.7(ガHand Bo〔)k()1｀1)rocedtl「cs(Vol.|)2009‐ 14 Clasc ()FM/s()ptinlll、 Dl・t:=｀P｀.11´ td l hc tilldcl・、isnccl is dil・cctctl t(、 1・efむr tt)1)(lF・r tI().、().01F8215013821Aヽ「1‐ 1611)liS‐ 3/417 datcd thc()7/07/15 、'idc、vhichそtpplicatioll li・olll 卜11s C)|)tinlLiS DrLlぎヽ I)vt i td、、tisヽCllt to thi、 1)epal・111lcnt ibr il、ation of n()rnls tilltler pant:4.7 1brthc c、P011 0f SO■,sbuvir(S)‐ lS()prOp)・ l‐2- ((S)‐(((2R,3R,4R,5R)-5‐ (2,4‐ I)lo■o‐3,4‐ Dihydr(〉pyrintidin‐1 (2H)‐ 4‐「luoro-3-11)=droxy‐ 4‐ Metil)':letrahydrofuran‐ 2‐y:)Mctho■)')― ll》hCno、y)PhOSpho■llantino)Pro:〕anOate Thi、 departillじnt has c、anlillc(l thc I、lattcr and thc,い1lo、villじ 111)rills arc llll・nished ttndcI・ P〔tra 4 7 ol｀ IIancl lふ()ok Of Pr(,cc(llll・じ、(ヽイ ()l.l)2009‐ 14:‐ (pl), ltcc()nllllcntictl kじ /k8. llt10ro-2-(｀‐nlct11、ltlridillc) 00(} 卜}yk2釣⊇ =10そmmmmハm。、xhふ3(「 II arrrino I propaucrate 1l ctt・ah、dr()illrtt!1 l )i rct:turate ( icnera l o l- Iro rci Llrr'l-r.acle. I )cpry1p1.r"r, o l' ('orn nrerce. tShri '1.\r. Singh. Ft-DO). t itllog lJharurn. Neu l)r.llri l()2 6.(X)litrk= 、 | (l]arnali Khastgir) t indcr Secrctar-v to the Covcntnlent ol'lncliu I,lront::li07l l6l |)'1・inlidi1lc_2、4(lII.31i,‐ (11(、lle(2‐ dじo、、 :_2-nti()rt、_2‐

F. No.350 1 1 tSB2t2O15-pt (Norms) GoVernment of lndia Department of pharmaceuticals Shastri Bhawan, New Delhi, Dated: March 10,2016 Sub:-Fixationofnormsunder,u,uffi/sAlembicPharmaceuticalsLtd. The undersigned is directed to refer to DGFT U.o. No. ollB2lSolooTo2lAM-16/DES-3 lB41 dated the 31/08r201s vide whi-ch an application from 1,yr.-nrlr;il;,h;;ffi;; Ltd was sent to this Department for fixation ol norms against export oi genzathine ,'. Peni.cillin 2'4 .Mega lnjections in 20 ml vials. This department n6 u*rri"u;'il:'matter and the following norms are furnished under para 4.7 of Hand Book ,f i;;;;;r;;r'ir;i:i 2009-14- Name of Export Products Quantity Raw Material to be imported Quantity recommended. 0.252 BOU Benzathine Pe nicillin 2.4 Mega lnjections in 20 ml vials(each vial contains 24,00,000 units of Benzathine Benzyl Penicillin 1 00 vials Benzathine Benzyl Penicillin sterile 2. This issues with the approval of Director (pharma lndustry). Phone: 23071162 Uspi3-Pharma@nic.in (Shri MVSingh,FTDO), Udyog Bhawan, New Delhi.

F. No.350 1 1 17351201 s-Pl (Norms) Government of lndia Dated: 28 March, 2016 Office Memorandum Case of M/s lnd-Swift Laboratories Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182150114021AM- 16/DES-3/1569 dated the 1511116 vide which application from M/s lnd-Swift Laboratories Ltd. was sent to this Department for fixation of norms under para. 4.7 for the export of Methyl-2-(SX2-Chlorophenyl)(2-thiene-2yl-ethylamino) Acetate HCL (lntermediate for Clopidogrel Hydrogen Sulphate). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol. l) 2009-1 4.- 2 (Rajkumar) PH'.- 23071162 S.No. lmport item 1kq Export 1 DL-2 chlorophenyl glycine 1 00kq 2 Methanol 4.87kq 3 Methvlene chloride 2.03ks 4 L(+)丁artarlc Acid 0.60kg 5 Acetone 0.34kg 6 Thiophene-2-ethanol 0 60kg 7 Toluene 1.11kq 8 P-Toluene sulfonvl chloride 1.029kq

No 46011/57ノ2009-PC― ll Government ofindia Ministry of Chemicals&FertiHzers Department of Chemicals&Petrochemicals οl l櫂ノト γ,% Room No. 223, A Wing, Shastri Bhawan, New Delhi-1 10 001 Dated the April 06, 2016 OFF]CE MEMORANDUM Sub: Application from M/s. Reliance lndustries Limited, Mumbai for issue of advance licence (Licence No. not given) for export of Paraxylene and corresponding import - reg. The undersigned is directed to refer to U.O. No. 01/82l050/01385/AM- 16/DES-lll/1540 dated 14.01.2016 from D.G.F.T on the subject cited above. The proposal of the firm has been examined in this office. The Department of Chemicals & Petrochemicals recommends the present Advance Authorization Application on the following basis :- Name of Export Items (s) Qty in MT Name of import ltem (s) Quantity Paraxylene One MT Reformate 1.376 MT Relevant Catalyst and Chemicals used in manufacture of Orthoxylene C:F va:ue to 90%ofFOB Va:ue of export This has approval of the competent authority. 」oint!ndustrial Adviser 丁el:011-23071442 Telefax1 011‐ 23071187 Email:omsharma@niC in shn Mahendra Vikram Singh, Foreign ttrade Development OfFicer, Directorate General of Foreign ttrade, Depanment Of Commerce, Ministry of Commerce and lndustry, Tel No 23061562,Extn 269 Fax:23062225/23061613 紫

Government of lndia Department of Chemicals and petrochemicals

Subject:-Advance Authorization application from M/s. AVA Chemicals Ltd. for the import of

raw material against the export export of Copper EDTA, cu Content 14o/o(+t-1)/EDTA Tetrasodium/ Disodium Manganese EDTA (Manganese content 12.5o/o (+^O.Solo)e-$-. The application has been examined and the Department recommends the following norms for the present Advance Authorization application.

ltem of Expor.t Qtv. Item of lmport Qty Disodium Manganese EDTA (Manganese content 12.5% (+l-0.5%) l kg EDTA (Ethylene Diamine Tetra Acetic Acid) 0.690 kg. ryffiffi (A.K. AGARWAL) Addl. lndustrial Adviser Tel. No. 011-2338 1430 Deptt. of C&PC U.O. No. 1401016712011-CH-ll dated 04.03.2016
ltem of Export Qty. Item of lmport Qty Copper EDTA, cu Content 14o/o(+l-1o7r1 l kg 1 Ethylene Diamine Tetra Acetic Acid
730 kg.
ltem of Export Qtv Item of lmport Qty EDTA Tetrasodium 1kg Ethylene Diamine Tetra Acetic Acid
750 kg.

0ノ|み /η ´/ヲーレらル Government of lndia Department of Chemicals and Petrochemicals

Subject: Advance Authorization application from M/s Sterling Auxilaries Pvt. Ltd. for the import

of raw material against the export of Surfectants. (Advance Authorization No. 0310799578 dated 2'l . 'l 0.20'1 5) Ref:- DGFT/ U.O. No. 01 l82l 50101 3931 AM 1 6/DES-| ll/1 455 dated "l 2.01.201 6. M/s. Sterling Auxilaries Pvt. Ltd. has submitted present applications for the import of raw materials against the export of Surfectants. The application has been examined and the Department recommends the following norms for the present Advance Authorization application. This issue with the approval of competent authority. Addl industrial Adviser Tel No 011-23381430 Deptt of C&PC U O No 14010/64ノ2013‐CH‐ !ldated 04 03 2016 1 . ltem of Export Qty Item of lmport Qty l Stersol EDGA(Diethylene Glycol A』ono Ethyl Ether Acetate) l kg l Ethano1 93% 0 3090 kq 2Ethvlene Oxide 0 5500 kq 3. Toluene 0 1500 kq 2. Stero CO 320 (Polyoxyethylene Triglyceride Ricinoleic Acid) l kg 1 . Ethylene Oxide 0 665 kg, ぃK儡い

oilfrnfi 3lY F. No.350'l 1/7091201s-Pl (Norms) Government of lndia Daled:22 March, 2016 Office Memorandum Case of M/s Saurav Chemicals Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501140614M- 16iDES-3/1543 dated the 1411116 vide which application from M/s Saurav Chemicals Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Alpha Lipoic Acid. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S.No. lmport ltem Norms Recommended for 1kq Export Ethyl 6,8-dichloro caprylate 2.166kq 2 PH:- 23071162

″ 34 Чζ} Shastri Bhawan, New Delhi, Dated: March 15, 2016 Sub:-Fixationofnorms,nouffi,.,onofM/sJ.B.Chemicals& Pharmaceuticals Ltd. The undersigned is directed to refer to DGFT U.o. No, 01lg2lsolsgo/AM-16/DES-3 /334 dated the 0210712015 vide which an application from M/s J.B. Chemicals & Pharmaceuticals Ltd was sent to this Department for fixation of norms against export of Sugar based Medicated Medi-keel A Throat Lozenges. This department has examined the matter and the- following norms are furnished:rnderr para'4.7 .of Hr;;-B;;k';; Procedures (Vol.l) 2009-14:- (Rai K面而ムr) Under Secretary to the Governmeni of lndia Phone: 23071162 Uspi3-Pharma@nic.in ,, l*rav 「 Nα 遁:|:儒』∫:鴻ir∝ m⇒ Ministry of Chemical&Fertilizers Product to be Exported Description m Raw materials tO Ъ … Description Quantity in gm Sugar based Medicated Medi- keel A Throat Lozenges. 100 lozenges Benzocaine 1.224 gm Cetylpyridinium chloride 0.153 gm ハ This issues with the approvar of Director (pharma rndustry). つ」 Depaftment of Commerce, (Shri MVSingh,FTDO), Udyog Bhawan, New Delhi.

F. No.3501 1 /69612015-Pl (Norms) Government of lndia Dated: 21 March,2016 Office Memorandum

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

Case of M/s Jodas ExPoim Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01l82l5Ol658lAM-16/DES- 3/802 dated lhe 14t\t15 vide which application from M/s Jodas Expoim Pvt. Ltd. was sent to this Department for fixation of norms under para: 4-7 for the export of Vancomycin HCL 1gm 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- DGFT is advised to call copy of drug manufacturing licence for the above export product and working on the requirement of imported APl. 2. (Rajku ma r) PH:- 23071162 Z升

No.46011/6/2013¨PC.H Govcrnment oflndia Ministry ofChemicals`と Fertilizcrs Departmcnt ofChcmicals&Petrochcmicals Room No.223, A Wing, Shastri Bhawan, New Delhi-l l0 001 Dated the 5th April,2016 OFFICE MEMORANDUM Sub: Application from IWs. Reliance Industries Ltd. for the import of raw material against the export of Benzene for issue of advance licence (DGFT Ref. No. 0 l/82/050/0 I 635/M- I 6/DES-III/I 794 dated. 03.3.20 I 6) - reg The undersigned is directed to refer to DGFT U.O. No. 011821050101635/M-16/DES- Illll794 dated. 03.3.2016 forwarded an application for issue of advance licence from IWs. Reliance Industries Ltd. for the import of raw material against the export of Benzene for issue of advance licence (Licence No. NOT GIVEN). The application has been examined in Department of Chemicals and Petrochemicals and the following norms are recommended for the reference licence application:- This has approval of the competent authority. / (0.Po Sharma) Joint lndustrial Adviser Tel:011-23071442 Telefax:011-23071187 Email:omsharlnaのnt.in Shri Mahender Vikaram Singh, Foreign Trade Development Officer, Ministry of Commerce and Industry, F ax: 2306 2225 123061 613 3Ч I Name of Export ltem(s) Qty in MT. Name of import ttem(s) Qty. in MT Benzene l MT Reformate 0。866ヽ4T :・

ハアЧ¬ F. No.350 |I1365l20i5-PI (Norms) Govemment of India Depaftment of Pharmaceutical s New Ddhュhe♂(耀i£lwi Office Memorandum Sub.iect: - Fixation of norms uncler para 4.7 of Hand Book of Proceclures (Vol.l) 2009- 14 Case of M/s Sun pl-rarrna h-rdustries Ltd. Tl-re undersignecl is directed to refer to DGFT U.O.No. 0lll2l50ll57lAM- l6/DES-31314 dated the 02101115 vide which application frorn M/s. Sun phamra Industries Ltd was serrt to this Depaftment for fixation of nonns uncler para: 4.7 for the expott of Valacyclovir/Valaciclovir Hydrochloride Tablets/Capsules. This depatttlent has exatnined the matter ar-rd the followilg nolrs are fugrisl-red under para 4.7 of l{and Book of procedures (vol .r) 2009-14:- つ一 This issues witl-r the approval of cornpetent authority. (Rai Kumar) Pl-rone:2307 I 162 Directorate General ol. Foreign Trade, Departrlent of Comnrerce, (Shri M.V. Singh, FT'DO), Udyog Bharvan, Neu, Delhi S.No. 1. Irnport Iteru Qty. Recornmended. Valacyclvoil・HcI BP/usP 5561ng/500nlg tablet & 上H2mg/1 000111g tablet

F. No.3 50 1 | 13421201 3-PI (Norms) Government of India Udyog Bhawan, New Delhi, the26th September,2013 Office Memorandum

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

2009-14 case of Nzvs DSM sinochem pharma India pvt Ltd. The undersigned is directed to refer to DGFT U.o.No. 01182/5011336/N}dl3/DES-3 11433 dated the 20103/13 vide which representation from M/s. DSM Sinochem Pharma India Pvt Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Amoxycillin Trihydrate Through 6-APA Route Through Enzymaiic Route. This department has examined the matter and the following norms are fumished under para 4.7 of Hand Book of Procedures (Vol .l) 2009-14:- つ ´ This issues with the approval of Director (Cost). (Raj Kumar) PI-Norms (Shri R.C. Meena, Dy. DGFT), Udyog Bhawan, New Delhi. S.No. Import Itern Qty. Recommended kg/kg. 1 6-APA 0.568 つ４ D(-)P-Hydroxy Phenyl Glycine M.tlryl.rt* 0.608 3. 7me) 5.0 gm/kg

@tltT F. No.350 1 1 1588120'1 s-Pl (Norms) Government of lndia Dated'.21 March, 2016 Office Memorandum Case of M/s Sun Pharma Industries Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501610/AM-16/DES- 31771 dated the 1018115 vide which application from M/s Sun Pharma lndustries Ltd. was sent to this Department for fixation of norms under para: 4.7 'for the export of Amoxycillin Trihydrate & Clavulanate Potassium+Avicel 1:1. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14'.- S.No. lmport ltem For Export of 1No. Tablet/Capsule 375mq 625mq 1000mq 1 Amoxvcillin Trihvd rate 289.017mg 578.03mq 1011 56mq 2 Clavu lanate Potassi um+Avicel 1:1 303.60m9 303.60m9 303.60m9 2 (Ralkumar) ∪nder Secretary to the(3overnment oflndia PH:-23071162

F. No 35011rcq1t2}15-pt (Norms) Government of lndia Ministry of Chemicals & Fertilizers Depa rtm ent of pJra rmace utica ls Shastri Bhawan, New Delhi, Dated the March 14,2016 Office Memorandum subject' - Fixation of norms under para 4.7 of Hand Book of procedures about request of Mis J.B. chemicars pharmaceuticars Ltd. The undersigned is directed to refer to DGFT U.o.No. 01lL2to50lo0742lAM- 16/DES-3/814 dated the 2olo/201S^vide which apptication from M/s J.B. chemicals Pharmaceuticals Ltd was sent to this Department rof iixation of norms under para.. 4.7 for the export of Kanamycin Acid Sulpirate tnleclion 1 gm/3ml Ampoules This department has examined the matter and foilowing norms are furnrshed._ i Ploduc.t to be Exported I Raw matlriats to be rmported I i Description I- I ' --,'i-r:-:-*- i i xanamycin Acjd. surphate l:':!:::,i r,rii, :i:' ::',, i,:;'#r,,,1 I lnjection 1 gm/3mt Ampoutes I j Sutphate I I l_1I""'P"qLc_li 2. Under se眈ね ry b he Govem話酬拙躙! Phonei_23071162 e mail:_uspi3 pharrlna@niC in

司η 俳ル “ 賊ゞ房漏 0.306 lozenges i hydrochloride This issues with the approval of Director (pharma lndustry) F No.3501 1138312015-Pl (Norms) Government of lndia [/linialrrr nf /-hnminrl Q. Enrliliznro rvrrl rrof rJl vl vl lul I llvur u I ul LllrLvi u Shastri Bhawan,New Delhil Datedi March 17,2016 Office Memorandum Sub. - Fixation of norms under para 4.7- Application of M/s J.B. Chemicals & Pharmaceuticals Ltd. The undersigned is directed to refer to DGFT U O. No. 01l92l50l424lAM-16/DES-3 /426 dated the 0710712015 vide which an application from M/s J.B. Chemicals & Pharmaceuticals Ltd. was sent to this Department for fixation of norms against export of (1) Difflam Sugar Free Lozenges in Raspberry/ Eucalyptus & Menthol/Honey & Lemon/ ,Orange/ Double Mint flavours (2) Andolex Lozenges Sugar Free Mint. 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.- Difflam Sugar Free Lozenges in Raspberrlr/ Eucalyptus & Menthol/Honey & 100 lozenges 暑―― ｎ　　　・Ｍ　　一ｅ　　　一ｅ　　　・Ｆ　　　　　一ａ　　　一ｕｇ　　一Ｓ　　一一一 (Raj Kumar) Phone: 23071162 Uspi3-Pharma@nic.in (Shri M V Singh,FttDO), Product to be Exported Description I Quantity Raw materials to be lmported

-|re,iir r pt r o n -- | -A u-a n t i t - * Benzydamine hydrochloride lsomalt S丁―M Cetylpyridinium Not needed as per DML S.A/0 257 2 0.306 258.60

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ちlι И暉 Governrnent of lndia Ministry r.ri Chemicai & Fertilizers Shastri Bhawan,New Delhi, Dated:Apri1 6,2016 0ffice Memorandum Sub: ― Fixation of nOrrns under para 4 7- ApplicatiOn of A/1/s 」.B.Chemical & Pharrnaceuticals Ltd The undersigned is directed to refer to DGFtt u.o.No 01′ 82/162/29/AM-16′ DES-3 /1687 dated 14/03/2016 fon″ arding additional inforrnatiOn about 7 pending app‖ cations of M/s」.B chernical&Pharrllaceuticals Ltd.Out Of the 7 applications,DoP has already conveyed its viellvs about app‖ cations listed at serial no.2,3,4,5&7 ofthe DGFT letter. (2)The remaining 2 app‖ catiOns listed at serial no l and 6 ofthe DGFT letter pertain to norrns against expOrt Of same prOducts namely Difflam sugar Free Lozenges in various flavours This department has exarnined the matter and the fo‖Owing norrns for each Of the 3 export products againstthese applications are furnished atfO‖ Ows:_ ノ
′ I Productto b6ビ支百6ied~ ~~~1良L"品aお薔 alこtOЪb品百6rtea l i bδ3″昴昴~~~~~l QLが r/ry寸―房Jδr/pみδ万可 ~o3Jttσ 扇1 |つ4∠イ ∩И n.A tt4t.o4mg | ; i Difftam AAA sugai rree Lozenges in j 100 | Benzydamine i o.abo BlackcurranuHoney & Lemon I rozenge i r,vorLrrr"riJ" i /Eucalyptus and Menthol Flavours.L- j i_ Each lozenge contains aenzyoamin; j ] , ^_ I Hvclrchlorirle 3 oo rnn rnr{ tcnmalr e-r r/r I I lsomall ST_M i 214-164 I iittlt lXA,.sugar Free Lozenges in j ,oo i a"n.yo,,,n" i 0 ab6 Hydrchlo百de 3 00 mg and lsOmlt sT_MI I !SOmali s「_M 1 214.164 91z11∩∠,■■∩ | ` ′ ~~~
コ ~… ~.ψ V,,,ult v[iV:
〕 | | 214■o4mg l l l l 2. This issues with the approvar of Director (pharma rndustry). Uirdei Secretary to the oorurn.,\X;i[',ffi? phone: 2307 1 t OZi_,rspr:_pha rma@nic. in Directorate General of Foreign Trade. (Shrr M V Singh, FTDO),Udyog Bhawan, New Delhi.

F. No.350 1 1 17 1912015-Pl (Norms) Government of lndia Dated: 22 F ebruary, 2016 Office Memorandum

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

14 Case of M/s Vital Healthcare Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182116212331A.M- 16/DES-3/1608 dated the 812116 vide which application from M/s Vital Healthcare Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of (1)Artemether, (2)Artesunate, (3)Dihydroartemisinin, (4)Lumefantrine 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.-

o. fC' t<-tl -*)-- (Rajkumar) 2. R6/ * ^-tiy' o"zi^o o.a e_.- Export Product S.No lmport ltem Norms Recommended for 1kq Export (1)Anemether 1(n Artemisin n 1 235kq (2) Artesunate Artemisin n 0.889kq (3)Dihvdroartemisinin Artemisin n 1 0989kq (4) Lumefantrine 9H Fluorene 0.90kq 2. Para Chloro Benzaldehvde 0.3476ks 3. Methanol 7.55kq 4. Methylene Dichloride 1 83kq

F. No.350 11 17461201 s-Pl (Norms) Government of lndia Dated: 7 March, 2016 Office Memorandum

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

14 Case of M/s Granules lndia Ltd. The undersigned is directed to refer to DGFT U.O.No.0'1 18215011283/AM- 16/DES-3/1329 dated the 18112115 vide which application from M/s Granules lndia Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of (2S,5R)-s-fluorocytosine-1-YL-[1 ,3]-oxathiolane-2-carboxylic acid menthyl ester (FCE). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14.- 2 (Rajkumar) PH- 23071162 S.No. lmport ltem Norms Recommended for '1kq Export Glyoxalic acid 50% 0.68kQ 2 Cyclohexane 1 227kQ 3 2, 5-d ihyd roxy-'1,4-d ithiane 0 28kq 4 5-fluoro cytosine 0.50kq 5 Methvlene chloride 3 671kQ 6 HMDS 0 53kq

F. No.350 1 1 17481201 s-Pl (Norms) Government of lndia Dated: 3 March, 2016 Office Memorandum

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

14 Case of M/s Hetero Drugs Ltd. The undersigned is directed to refer to DGFT U.O.No. O1t82tSOtg30/AM- 16/DES-3/1336 dated the 18112115 vide which application from M/s Hetero Drugs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the ex[ort of Montelukast sodium. This department has examined the matter and the foilowing norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2OOg-14:- 2. (Rajkumar) PH:- 23071162 S.No. lmport ltem Norms Recommended for 1kq Export 2-(2-3S-3, 2,7 -chloro-2-q uinolinyl)-ethynytpfrenyry;- hyd roxy propyl)-phenyl-2-propanol 1.24k9 2 1 -(mercapto methyl)-1 -cyclopropane acetic acid 0 40kq

F. No.3501 1 17 41 12015-Pl (Norms) Government of lndia Dated: 19 February, 2016 Office Memorandum

Subject: - Fixation o-f norms under para 4.7 of Hand Book of Procedures (Vol.l) 2OOg-

14 Case of M/s Supriya Lifescience Ltd. The undersigned is directed to refer to DGFT U.o.No. o1tg2l5ot1152lAw- 16/DES-3/1293 dated the 16112115 vide which application from M/s Supriya Lifescience Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Bupropion Hydrochloride. This department has examined the matter and the fo‖ owing nOrrns are furnished under para 4.7 of Hand Book of Procedures 2. Under Secretary to the oou"rn.S?.|ji,ffi? Department of Com merce, .t) 2009-14'.- S No lmport ltem 1kg Export 3-Chloro Propiophenone 0.85kq● 2 N-Methyl 2-Pyrrolidone 1 036kq 3. Tertiary Butylamine 1.21ks

F. No.3 50 | I I 601 12014-PI (Norms) Govemment of India Udyog Bhawan, New Delhi, the April, 2015 Office Memorandum

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

2009-14 Case of M/s Eytan Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501659/AM- 15/DES-31879 dated the 03ll2ll4 vide which application from M/s. Eytan Labs Ltd was sent to this Department for fixation of norrns under para: 4.7 for the export of L-Menthyl Glyoxylate Hydrate(McH). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol .l) 2009-14.- S. No. Import Item Qty. Recommended kg/kg. 1 Glyoxylic Acid 50% 0。752 ９一 Cyclohexane 1.41 2. This issues with the approval of Director (PI). (Barnali Khastgir) Phone:23 071162

/11オイ 5影 F. No.3501 1 I 641 12015-PI (Norms) Government of India Ne、v Dclhi,thc Udyog Bhawan, December, 2015 Office Memorandum

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

of M/s Vasudha Pharma Chem Ltd. The undersigned is directed to refer to DGFT U.O.No. 0ll82l501327lAM-l6lDES-3l788 dated the 13/08/15 vide which application from M/s. Vasudha Pharma Chem Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of 2-Bufyl-4-Formyl Imidazole (Or) 2-Butyl-lH-Imidazole-5-Carboxaldehyde. This department has examined the matter and the following norns are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14- S.No. Import Item Qty. Recommended kg/kg. 1 2Q.J-Butyl)-4-Chloro-5 -Formayl Imidazole 1.45 うん Methanol 0.96 3. Methylene Dichloride 0.83 4. Activated Carbon 0.05 つ乙 (Raj Kumar) Phone:23071162

F. No.350 1 1 17461201 s-Pl (Norms) Government of lndia Dated: 7 March, 2016 Office Memorandum

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

14 Case of M/s Granules lndia Ltd. The undersigned is directed to refer to DGFT U.O.No.01 18215011250/AM- 16/DES-3/1365 dated the 21112115 vide which application from M/s Granules lndia Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of 1-(2,4-datluoro phenyl)-2-(1H-1 ,2,4-triazole-1-yl) ethanone (Ethanone Derivate). 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'.-

(Rajkumar) PH.- 23071162 S.No. lmport ltem Norms Recommended for 1kq Export 1 1,3-difluoro benzene 0 60kq 2 4-am i no- 1,2,4 -triazole 0 47kq 3 Methylene chloride 1.41kq 2

/ ト ― ノ ′ ０ / Governrnent of lndia lvlinistry of Chemicals and Fertilizers Deparirnenl of Chemicals and Petrochemicals Su"ljecl A,jvarrce Aulhorization applicalion from Mis. Yasho lndusiries Pr,'t- Ltd. lor the impo( o[ rav; materrals againsi the export of EUTYLATED HYDROXY ANISOLE(BFiA), etc. The applications has been examineo' and the Department recommends the following norms for the present Advance AL〕thOrization No_ 03107ヨ8032 dated 24.122012 llem si lnrport (Adソance ALlthOriヱation No_ 0310795524 dated 24.4.201 Item of lmport -Aromatic-derivative of I 1 k(l. ' diphenylamine(ADA) ME (Adr,ance Authorization IJYDROXY 1 l k9 o31o/s85Bs c31079323S 31.8,2015) /" 20.8.2015,イ Oty_ ltdm oFlmpOrt ０　０ＮＮ dated dated 「芋籠篇聾撮器塑:望 YA『02020120%SOLじT10N OF TERTIARY 8UTYL HYDROQU!NONE〕 l kg 11, HYD■0001NONE ′ ntutho「:こュilon rlo. Ool11'l」,241 dalじJ O′ 10.20 1 llern ol Export YANT Q 3030 B(300/。SOL OF EPT,ARY BIJttYL HYDR001り |卜′0卜J「) This issues viith the approval of competent authority- Shl Mnl,endCr VikaranSinch.興QES-310ノoDG「F.Udvocl Bhawan,New Delhi-11. Deptt.oFCaPC U.o.No´ 14010/95ノ2011‐CHヽll dated 23 11_2015 七 P/フ晨戸」江2≠ア 5 | | 0.200 kg (AK,ACARWAL)‐ Addl.indust,3:A山薇o「 Tel.No.011‐23381430 ; Advance Authorization applications Itenr of Export 2丁ERT:ARY BUTANOL

llem oi E.rpcrt ' =:l LIヽ lFバlくYけtJ}ハ140L 3 PROpvLEl,EらLYC OL l k9′ !1, HYDF00UINONE ― ― ― ― ― ― ― ― ― ― ― ― ― ― ＩＩＩＩＩ ‥ ‥ ‥ ‥ ‥ ‥ １１１１１日Ｅｌ日日 ― 日日 ― ― ― ― ― ― ― ― ― ― ― ― ■ ■ ― ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ 日 ■ ■ ■ ■ ■ ■ ■ ■ ■

ntll-V ,rl 0- 07- F. No.3 50 I 1 I 65 I 12015-PI (Norms) Government of India Ministry of Chemicals & Fertilizers Udyog Bhawan,New Delhi. Dated: 1 February,2016 Office Memorandum

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

of M/s Aurobindo Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182150100826/AM-16/DES- 31878 dated the 2l09ll5 vide which application from M/s. Aurobindo Pharma Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Simvastatin. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book Of 2. (Rttkuma⇒ Undcr Sccrctary to the Govemmcnt oflndia Phonc:23071162 DircctOrttc Genera1 0f Foreign Trade, Departmcnt of COllllinerce, (Sl■ri M.V.singh,FTDO), ol Procedures(Vol.1)2009-14:― S.No. Import Item Norms Recommended for lke Export 1 Activated Carbon 0.035kg うん Cyclohexane 1.77kg 3. Dimethyl fOrmalnide 1.33kg 4. Imidazole 0.58kg 5。 Lovastatin 1.39kg 6. Methane Sulphonic Acid 0.060kg 7. Methanol 8.63kg 8. Methylene Chloride 2.43kg 9. n-Butyllithium( I 5% solution in hexane) 0.610kg 10. Pyrrolidine 0.778kR Tertiary butyldinlethylsilyl ch10ride 0.779kg 12. Tetra Hydrofuran 3.04kg うＤ Methyl― IOdde 0.166kg

`´ ο7 ′ ／ ′ （　一洒響ポ齢野｀‐ F・li:J 正‐ ″ 1‐ l・ ^ill 酔喚臨轟私轟藝桑F16語i緊税鴛‖Wttp為鷹 r」 committee conside「ed ca〔 before the Committee and explalned the case.He in licence they have obtained for export of Cevamune・ product application oniy Comnlittee, after detaled de!ibe「ations and ri:1器Ll:鮮魚『洲穏鵠∬Tり謬烈、 M喫岬 IW墜亜型H嘩里■型呻燿 ""… ⅢO頸_三賀「蝕鳳」 before the Committee and explalned the case.He informed that Committee thatthis is the Firm advance ▼ ‐ ~

醍ル /0 F.No.35011/297/2014-PI(Norms) Government oflndia Ministry Of Chemical&Fertilizers Dated: 15 March, 2016 Office Memorandum

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

Case of M/s Saurav Chemicals Ltd. The undersigned is directed to refer to DGFT U.o.No. 01tg2t5otg65/AM-12IDES- 311624 dated the 1612116 vide which representation from M/s Saurav Chemicals Ltd. was sent to this Department for fixation of norms under para: 4.T for the export of ILC (1s,4s,5s)-4-toDo-6-oxABrcycLo[3,2,1]ocrAN-7-oNE. This department has examined the matter and considering tne t,echnical unviability of using sodium hydride forFeyelinlrof-R:lsorne-r-n-dfi-lin-twith-centrat-rxase-ceniricate--tffi--- revised as under:- S.No. |… Revised Norms Recommended for'1kg EIport 1 d 3 00kg 2 r-(-fl- r pnenytethytamtne lodine

Potassiumioffi 2.50kg 3 1.18kg 4 0.35kg 2. Under Secretary to the Directorate General of Foreign Tr'ade, (triljkumar) Government of lndia PH:-23071162 可′ ifヱ｀賓ξ平要墓轟璽国□ ||■1.二十==二~~―一一一

σ r/β″一ノア lζ″′つ :′ Government of lndia linistry of Chcmicals and l-ei-tilizei-s Department of Chemicals and Petrochemicals Sublecti― Representation from M/s CAMPHOR&ALLIED PRODUCTS Ltd forthe raw matettals against the export of Astrolide(lPM/BB)Astrolide ih Myristate/Benttyl BenzOate total Astrolide content 62 5%minimum) (Advance Autho「ization No 0310704836 dated 10 8 2012) Rei UO No 01/82/50/623/AM13/DES― l‖ /1602,dated 5 2 2016 丁he application has been exarnined alld the Department recorllmends the norrlls for thё present Advance Authorization application This issues with the approval of competent authority import of lsopropyl following (A K ACARIA/AL) Addl lndustrial Adviser Tel No 011-23381430 .Sh『iヽ』ahendl Deptt Of C&Pc No.14010/47/2014-CH― |l dated 04 03 2016

ltem of Export Qty Item of lmport Qtv Astrolide(lPM/BB) Astrolide in Isopropyi Myristate/Benzyl Benzoate . Total Astrolide content 62.5% minimum). l k9 1 1SOAMYLEN巨 0 100 Kg 2 PROPYLENE OXIDE 0_280 kg 3 ALPHA MEttHYL SttYRENE 0,500 kg― 4 PARAFORMALDEHYDE 0,088 k9 5 1SOPROPYL MYRISTATE 0.350 kg ´ |

爵 ∫ ■ 一ｒ ξ ご Government of lndia Department of Chemicals and petrochemicals SubieCt―Advance Authottzation applicalon from M/s.CAMPHOR&ALLIED PRODUCTS Ltd. for the import Of raw matettals against the export Of Astrolide(DEPttPM/BB)(Astrolide in Diethylphthalate/ lsOpropyl A/1yristate/ Benzyl Benzoate/ Dipropylene Glycol total Astrolide content 62.5%minimum) (Advance Authottzation No.0310706272 dated 24.82012) Rei U.O No 01/82/50/741/AM13/DES― l‖ /1603,dated 5 2.2016 The application has been examined and the Department norms for the present Advance.Authorization application. recommends the following

ltem of Export Qty. Item of lmport ―Qty ' Astrolide(DEP/l PM/BB/Dpc) (Astrolide in Diethylphth atatel lsopropyl Myristate/ Benzyl Benzoatel Dipropylene Glycol total Astrolide content 62.5o/o minimum). l kg. l lSOAMYLENE 0.380 Kg. 2 PROPYLENE OXIDE 0.280 kg 3 ALPHA MET自 0.500 kg 4 PARAFORMALDEHYDE 0.0880 kg 件
も Addl.lndustrial Adviser Tel.No.011-23381430 n ra | 丁 Deptt.of c&Pc U.〇.No. 14010/47/2014¨ CH― ll dated 04.032016

●

了ノノ ′ 　　亀） ′ ′ ｒ ¨ 　　　　　　　ブＦ ′ ′ ´ ノ √ 〇//64-′ 7 Government of lndia Depa rtment of Chem icals a nd p"iro.f..,uri.rf . SutteCti― RepresentaIOn from M/s.cAMPHoR&ALLIED PRODUctts Ltd.fOr 騨 isL冦「型 izittl魂」 [t淵ょ r』Lょ淵翼£砒襦im需釧 de (Advance Authoriza‖ On No.0310712193 dated 9.10.2012) Rei u.o.No.o1/82/50/1o71/AM13/DES― ll1/1601 dated 5.2.2016 θ_′ タノ the import of in lsopropyl norms r]iirJ3:J::lil.ffi""T;,ffili1""t#fl.j?:,Deparrment recommends the foilowins 珈嘲 inoh of C&Pc No. 14o1oJiJfrTq_cu_u dated o… 1.llem ofT l咄 Benzoate, Totil Astrolide content 62.5% minim um). 1.ISOAM面 2 PROPYLENE OxlDE 3.ALPHA METHYL STYRENE 4.PARAFORMALDEHYDE 5.lsoPROPYL MYRISTATE

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