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

DGFT Committee Minutes

Document text

Government of India Ministry of Commerce and Industry Directorate General of Foreign Trade
Maulana Azad Road, New Delhi 110011

Norms Committee-III

Para 4.7 Decision

Meeting No. 07/82/2016 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, scheduled to be held on 07.07.2016 but actually held on 20.07.2016 under the Chairmanship of Shri J.V. Patil, Addl. Director General of Foreign Trade in Room No.04, Udyog Bhawan, New Delhi.

Following members were present:-

Shri Nirmal Kumar, Dy. Director General of Foreign Trade Shri D.N.Mathur, Consultant, D/o Pharmaceuticals.

Note: In certain cases the decision of the Norms Committee refers to the Recommendations/ Observations / Deficiencies received from the concerned Technical authority in the same case or a different case of another firm with the same product. A scanned copy of such document is placed at the end of the Minutes. In some cases, the scanned copy uploaded may be unsigned.
In both these instances, the scanned copy uploaded is to be accepted. The Committee does not approve SCOMET items and all applicants are understood to have furnished a declaration to RA that the items of import/export are not SCOMET items. MEETING NUMBER
: 7/82-ALC4/2016 MEETING DATE : 07.07.2016

Case No.:13/12/82-

ALC4/2013
Party Name:HETERO DRUGS LIMITED, Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Approved HQ File :01/82/050/00437/AM14/
RLA File :09/24/040/00495/AM13/
Lic.No/Date:0910054735 09.01.2013 Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/652/2013-PI(Norms) dated 17.06.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.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:7/82- ALC4/2016 07.07.2016 Status:Approved HQ File :01/82/050/01309/AM16/
RLA File :03/95/040/00881/AM10/
Lic.No/Date:0310726567 04.03.2013 Defer Date:
Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC for the same export product of same firm in NC meeting No.04/82 dated 16.05.2013, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07

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

Case No.:30/7/82-ALC4/2016 Party Name:NECTAR

LIFESCIENCES LIMITED, Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Case Deferred. HQ File :01/82/050/00204/AM17/
RLA File :22/24/040/00069/AM14/
Lic.No/Date:2210014463 20.12.2013 Defer Date: 10.08.2016 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/128/2016-PI(Norms) dated 11.07.2016, uploaded at the end of these minutes and deferred the case.

Case No.:52/6/82-ALC4/2014 Party Name:UPL LTD.

Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00454/AM15/
RLA File :03/95/040/01043/AM14/
Lic.No/Date:0310776594 01.04.2014 Defer Date:10.08.2016 Decision :Deferred

Case No.:88/6/82-ALC4/2014 Party Name:UPL

LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00490/AM15/
RLA File :03/95/040/00033/AM15/
Lic.No/Date:0310782129 20.05.2014 Defer Date:10.08.2016 Decision :Deferred

Case No.:61/4/82-ALC4/2014 Party Name:V & V PHARMA

INDUSTRIES Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00309/AM15/
RLA File :03/95/040/00190/AM15/
Lic.No/Date:0310785305 13.06.2014 Defer Date:10.08.2016 Decision :Deferred

Case No.:69/4/82-ALC4/2014 Party Name:RA CHEM

PHARMA LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Rejected HQ File :01/82/050/00317/AM15/
RLA File :09/24/040/00175/AM15/
Lic.No/Date:0910060550 27.06.2014 Defer Date:
Decision :The Committee observed that complete set of application has been called for from the firm as well as RA by NC in its meeting dated 18.11.2015 but same has not been received so far. In absence of the above norms cannot be ratified. The Committee accordingly, decided to reject the case.

Case No.:73/9/82-ALC4/2014 Party Name:D. R. COATS INK

& RESINS PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00870/AM15/
RLA File :03/94/040/00755/AM14/
Lic.No/Date:0310786181 30.06.2014 Defer Date:10.08.2016

Decision :Deferred.

Case No.:79/9/82-ALC4/2014 Party

Name:METROPOLITAN EXIMCHEM LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00876/AM15/
RLA File :03/95/040/00337/AM15/
Lic.No/Date:0310787073 18.07.2014 Defer Date:10.08.2016 Decision :Deferred.

Case No.:396/5/82-

ALC4/2015
Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00536/AM16/
RLA File :17/24/040/00047/AM15/
Lic.No/Date:1710005887 24.07.2014 Defer Date:10.08.2016 Decision :Deferred.

Case No.:63/8/82-ALC4/2014 Party Name:ADCOCK

INGRAM LTD, Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00727/AM15/
RLA File :07/24/040/00148/AM15/
Lic.No/Date:0710106181 25.07.2014 Defer Date:10.08.2016 Decision :The committee decided to send copy of application to DoP and deferred the case.

Case No.:32/9/82-ALC4/2014 Party Name:CHEMCON

SPECIALITY CHEMICALS P LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00829/AM15/
RLA File :34/24/040/00102/AM15/
Lic.No/Date:3410040406 28.07.2014 Defer Date:10.08.2016 Decision :Deferred.

Case No.:8/6/82-ALC4/2014 Party Name:V & V PHARMA

INDUSTRIES Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00410/AM15/
RLA File :03/95/040/00331/AM15/
Lic.No/Date:0310787382 28.07.2014 Defer Date:10.08.2016 Decision :Deferred.

Case No.:58/9/82-ALC4/2014 Party Name:G AMPHRAY

LABORATORIES, Meet No/Date:7/82- ALC4/2016 07.07.2016 Rejected HQ File :01/82/050/00855/AM15/
RLA File :03/94/040/00171/AM15/
Lic.No/Date:0310787536 01.08.2014 Defer Date:
Decision : The Committee observed that copy of application has been called for from RA as well as from the firm by NC in its meeting dated 18.11.2015 but same has not been received so far. In absence of the above norms cannot be ratified. The Committee accordingly, decided to reject the case.

Case No.:49/9/82-ALC4/2014 Party Name:SANMAR

SPECIALITY CHEMICALS LIMITED, Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00846/AM15/
RLA File :04/24/040/00106/AM15/
Lic.No/Date:0410159125 01.08.2014 Defer Date:10.08.2016 Decision :Deferred.

Case No.:31/9/82-ALC4/2014 Party Name:AMBERNATH

ORGANICS PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00828/AM15/
RLA File :03/94/040/00074/AM15/
Lic.No/Date:0310787610 04.08.2014 Defer Date:10.08.2016 Decision :Deferred.

Case No.:2/14/82-ALC4/2015 Party Name:SHREE

SHIVSHANKAR DRUGS & PHARMACEUTICALS P. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01138/AM16/
RLA File :03/95/040/00425/AM15/
Lic.No/Date:0310788055 14.08.2014 Defer Date:10.08.2016 Decision :Deferred.

Case No.:48/5/82-ALC4/2015 Party Name:VISION DRUGS

PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00188/AM16/
RLA File :09/24/040/00260/AM15/
Lic.No/Date:0910060860 18.08.2014 Defer Date:10.08.2016 Decision : The Committee noted that information called for from the firm by NC in its meeting No.05/82 dated 08.06.2016 is awaited. The Committee accordingly decided to await the reply from the firm and deferred the case.

Case No.:215/13/82-

ALC4/2014
Party Name:GOLD STAR CHEMICALS PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01218/AM15/
RLA File :03/94/040/00358/AM15/
Lic.No/Date:0310788338 25.08.2014 Defer Date:10.08.2016 Decision :Deferred.

Case No.:45/13/82-ALC4/2014 Party Name:HETERO DRUGS

LIMITED, Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/01048/AM15/
RLA File :09/24/040/00275/AM15/
Lic.No/Date:0910060885 25.08.2014 Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/630/2014-PI(Norms) dated 17.06.2016,

Case No.:377/5/82-

ALC4/2015
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00517/AM16/
RLA File :03/94/040/00493/AM15/
Lic.No/Date:0310788472 27.08.2014 Defer Date:10.08.2016 Decision : The Committee noted that information has been called for from the firm in NC meeting No.05/82 dated 08.06.2016 is awaited. The Committee accordingly decided to await the reply from the firm and deferred the case.

Case No.:224/13/82-

ALC4/2014
Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01227/AM15/
RLA File :03/94/040/00391/AM15/
Lic.No/Date:0310788515 28.08.2014 Defer Date:10.08.2016 Decision :Deferred.

Case No.:225/13/82-

ALC4/2014
Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01228/AM15/
RLA File :03/94/040/00397/AM15/
Lic.No/Date:0310788514 28.08.2014 Defer Date:10.08.2016 Decision :Deferred.

Case No.:262/13/82-

ALC4/2014
Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01265/AM15/
RLA File :03/94/040/00971/AM14/
Lic.No/Date:0310788560 01.09.2014 Defer Date:10.08.2016 Decision :Deferred.

Case No.:223/13/82-

ALC4/2014
Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01226/AM15/
RLA File :03/94/040/00508/AM15/
Lic.No/Date:0310788647 02.09.2014 Defer Date:10.08.2016 Decision :Deferred.

Case No.:3/7/82-ALC4/2014 Party Name:S V CHEM

INTERMEDIATES P LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00647/AM15/
RLA File :04/24/040/00139/AM15/
Lic.No/Date:0410159328 02.09.2014 Defer Date:10.08.2016 Decision :Deferred.

Case No.:400/5/82-

ALC4/2015
Party Name:YASH RASAYAN & CHEMICALS Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred

HQ File :01/82/050/00540/AM16/
RLA File :34/24/040/00120/AM15/
Lic.No/Date:3410040554 15.09.2014 Defer Date:10.08.2016 Decision :Deferred.

Case No.:12/15/82-

ALC4/2014
Party Name:JINDAL DRUGS LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01299/AM15/
RLA File :03/94/040/00460/AM15/
Lic.No/Date:0310789265 16.09.2014 Defer Date:10.08.2016 Decision :Deferred.

Case No.:15/13/82-

ALC4/2014
Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01018/AM15/
RLA File :34/24/040/00161/AM15/
Lic.No/Date:3410040594 30.09.2014 Defer Date:10.08.2016 Decision :Deferred.

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

AROMATICS PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01545/AM15/
RLA File :03/94/040/00594/AM15/
Lic.No/Date:0310789922 01.10.2014 Defer Date:10.08.2016 Decision :Deferred.

Case No.:372/5/82-ALC4/2015 Party Name:DR J

PHARMACHEM (INDIA)(PROP.ADITYA PRAMOD JOGDEO) Meet No/Date:7/82- ALC4/2016 07.07.2016 approved HQ File :01/82/050/00512/AM16/
RLA File :31/83/040/00154/AM15/
Lic.No/Date:3110064948 08.10.2014 Defer Date:
taken by NC for same export product in its meeting No.16/82 dated 21.11.2013, as per the details given below or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.

Export product Exp. Qty. Sl. No. Import items Qty. allowed
Sodium Benzoate Micronised 1kg 1 Sodium Benzoate 1.01 kg

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

Case No.:29/13/82-

ALC4/2014
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01032/AM15/
RLA File :05/23/040/00268/AM15/
Lic.No/Date:0510391490 08.10.2014 Defer Date:10.08.2016 Decision :Deferred.

Case No.:124/13/82-

ALC4/2014
Party Name:PANACEA BIOTEC LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01127/AM15/
RLA File :05/24/040/00319/AM15/
Lic.No/Date:0510391623 17.10.2014 Defer Date:10.08.2016 Decision : Information called for in NC meeting No.03/AM17 is awaited. The Committee accordingly deferred the case.

Case No.:198/5/82-

ALC4/2015
Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00338/AM16/
RLA File :04/24/040/00205/AM15/
Lic.No/Date:0410159704 11.11.2014 Defer Date:10.08.2016 Decision : The Committee decided to defer the case for want of comments of DoP.

Case No.:126/8/82-

ALC4/2015
Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00922/AM16/
RLA File :03/94/040/00710/AM15/
Lic.No/Date:0310791177 18.11.2014 Defer Date:10.08.2016 Decision :Deferred.

Case No.:43/18/82-

ALC4/2014
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01409/AM15/
RLA File :03/95/040/00701/AM15/
Lic.No/Date:0310791419 26.11.2014 Defer Date:10.08.2016 Decision :Deferred.

Case No.:362/5/82-ALC4/2015 Party Name:KLJ

PLASTICIZERS LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Approved HQ File :01/82/050/00502/AM16/
RLA File :05/23/040/00377/AM15/
Lic.No/Date:0510392211 28.11.2014 Defer Date:
Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.6 dated 29.08.2014 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No.:145/5/82-

ALC4/2015
Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00285/AM16/
RLA File :03/94/040/00877/AM15/
Lic.No/Date:0310792112 17.12.2014 Defer Date:10.08.2016 Decision :Deferred.

39 Case No.:127/5/82- ALC4/2015
Party Name:EMAMI LIMITED, Meet No/Date:7/82- ALC4/2016 Deferred

07.07.2016 HQ File :01/82/050/00267/AM16/
RLA File :02/24/040/00183/AM15/
Lic.No/Date:0210205355 18.12.2014 Defer Date:10.08.2016 Decision :The Committee decided to send copy of application to MSME and deferred the case.

Case No.:133/5/82-ALC4/2015 Party Name:AARTI

INDUSTRIES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Approved HQ File :01/82/050/00273/AM16/
RLA File :03/94/040/00883/AM15/
Lic.No/Date:0310792178 19.12.2014 Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/824/2015-PI(Norms) dated 06.06.2016 , uploaded

Case No.:136/5/82-

ALC4/2015
Party Name:AVIGNON EXIM PVT.LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00276/AM16/
RLA File :03/94/040/00843/AM15/
Lic.No/Date:0310792314 23.12.2014 Defer Date:10.08.2016 Decision :Deferred.

Case No.:221/5/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00361/AM16/
RLA File :09/24/040/00537/AM15/
Lic.No/Date:0910061442 23.12.2014 Defer Date:10.08.2016 Decision :Deferred.

Case No.:114/5/82-

ALC4/2015
Party Name:NATIONAL TUBE INDUSTRIES, Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00254/AM16/
RLA File :03/95/040/00756/AM15/
Lic.No/Date:0310792363 24.12.2014 Defer Date:10.08.2016 Decision :Deferred.

Case No.:218/5/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00358/AM16/
RLA File :09/24/040/00552/AM15/
Lic.No/Date:0910061462 29.12.2014 Defer Date:10.08.2016 Decision :Deferred.

Case No.:99/18/82-

ALC4/2014
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File RLA File Lic.No/Date:0710107307 Defer

:01/82/050/01465/AM15/
:07/24/040/00302/AM15/
30.12.2014 Date:10.08.2016 Decision :Deferred.

Case No.:111/18/82-

ALC4/2014
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01477/AM15/
RLA File :07/24/040/00307/AM15/
Lic.No/Date:0710107306 30.12.2014 Defer Date:10.08.2016 Decision :Deferred.

Case No.:28/7/82-ALC4/2015 Party Name:PARAMOUNT

AROMACHEM PVT.LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/00633/AM16/
RLA File :05/24/040/00428/AM15/
Lic.No/Date:0510392678 05.01.2015 Defer Date:
Decision : The Committee decided to ratify norms repeat basis based on the earlier decision taken by NC in its meeting No.11 dated 26.11.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take

Case No.:45/5/82-ALC4/2015 Party Name:SUVEN LIFE

SCIENCES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00185/AM16/
RLA File :09/24/040/00558/AM15/
Lic.No/Date:0910061483 05.01.2015 Defer Date:10.08.2016 Decision :Deferred for want of comments from DoP.

Case No.:102/5/82-

ALC4/2015
Party Name:ALTA LABORATORIES LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00242/AM16/
RLA File :03/94/040/00836/AM15/
Lic.No/Date:0310792635 07.01.2015 Defer Date:10.08.2016 Decision :Deferred.

Case No.:74/5/82-ALC4/2015 Party Name:NEW ALLIANCE

DYE-CHEM PVT. LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00214/AM16/
RLA File :03/95/040/00833/AM15/
Lic.No/Date:0310792647 07.01.2015 Defer Date:10.08.2016 Decision :Deferred.

Case No.:149/5/82-

ALC4/2015
Party Name:ALCHEMIE LABORATORIES Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00289/AM16/
RLA File :03/94/040/00813/AM15/
Lic.No/Date:0310792673 08.01.2015 Defer Date:10.08.2016 Decision :Deferred.

Case No.:121/5/82-ALC4/2015 Party Name:UNIJULES LIFE

SCIENCES LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Rejected HQ File :01/82/050/00261/AM16/
RLA File :03/95/040/00835/AM15/
Lic.No/Date:0310792685 08.01.2015 Defer Date:
Decision : The Committee observed that technical information has been called for from the firm by NC in its meeting dated 16.11.2015 and 14.01.2016 but reply has not been received so far. In absence of these information norms cannot be ratified. The Committee accordingly, decided to reject the case.

Case No.:219/5/82-

ALC4/2015
Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00359/AM16/
RLA File :09/24/040/00549/AM15/
Lic.No/Date:0910061517 09.01.2015 Defer Date:10.08.2016 Decision :Deferred.

Case No.:239/5/82-ALC4/2015 Party Name:MYLAN

LABORATORIES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Rejected HQ File :01/82/050/00379/AM16/
RLA File :09/24/040/00555/AM15/
Lic.No/Date:0910061520 09.01.2015 Defer Date:
Decision : The Committee noted that Central Excise Certification for production consumption called for from the firm by NC in its meeting dated 16.09.2015 has not been received so far. Firm has sent their reply but Central Excise Certification for production consumption not furnished. In absence of the above norms cannot be ratified. The Committee accordingly, decided to reject the case.

Case No.:141/5/82-ALC4/2015 Party Name:AARTI

INDUSTRIES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Approved HQ File :01/82/050/00281/AM16/
RLA File :03/94/040/00746/AM15/
Lic.No/Date:0310792870 13.01.2015 Defer Date:
taken by NC in its meeting No.03 dated 08.05.2014 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take

Case No.:119/5/82-ALC4/2015 Party Name:SHALINA

LABORATORIES PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Rejected HQ File :01/82/050/00259/AM16/
RLA File :03/95/040/00843/AM15/
Lic.No/Date:0310792869 13.01.2015 Defer Date:
Decision : The Committee observed that information called for from the firm by NC in its meeting dated 16.12.2015 and 09.03.2016 has not been received so far. In absence of these information norms cannot be ratified. The Committee accordingly, decided to reject the case.

Case No.:243/5/82-ALC4/2015 Party Name:SUVEN LIFE

SCIENCES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Rejected HQ File :01/82/050/00383/AM16/
RLA File :09/24/040/00589/AM15/
Lic.No/Date:0910061530 14.01.2015 Defer Date:
Decision : The Committee observed that information has been called by NC in its meeting dated 18.11.2015 and 16.12.2015 but reply has not been received so far. In absence of these information norms cannot be ratified. The Committee accordingly, decided to reject the case.

Case No.:112/5/82-

ALC4/2015
Party Name:UNIMAX CHEMICALS PVT LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00252/AM16/
RLA File :03/95/040/00812/AM15/
Lic.No/Date:0310793039 19.01.2015 Defer Date:10.08.2016 Decision :The Committee noted that an investigation in the matter is under process. The Committee accordingly, decided to defer the case.

Case No.:88/5/82-ALC4/2015 Party Name:ABEERS

PHARMACEUTICALS PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00228/AM16/
RLA File :05/23/040/00486/AM15/
Lic.No/Date:0510392949 21.01.2015 Defer Date:10.08.2016 Decision :Deferred for want of comments from AYUSH.

Case No.:138/8/82-

ALC4/2015
Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00934/AM16/
RLA File :03/94/040/01099/AM14/
Lic.No/Date:0310793426 30.01.2015 Defer Date:10.08.2016 Decision : Information called for from the firm in NC meeting No.18/82 dated 10.02.2016 is awaited. The committee decided to await the reply and deferred the case.

Case No.:275/5/82-

ALC4/2015
Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00415/AM16/
RLA File :03/94/040/00930/AM15/
Lic.No/Date:0310793539 03.02.2015 Defer Date:10.08.2016 Decision :Deferred.

Case No.:284/5/82-ALC4/2015 Party Name:J.B. CHEMICALS

& PHARMACEUTICALS LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Approved HQ File :01/82/050/00424/AM16/
RLA File :03/94/040/01053/AM15/
Lic.No/Date:0310793620 05.02.2015 Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/383/2015-PI(Norms) dated 17.03.2016,

Case No.:133/7/82-ALC4/2016 Party Name:SIRMAXO

CHEMICALS PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Case Deferred HQ File :01/82/050/00307/AM17/
RLA File :03/95/040/00911/AM15/
Lic.No/Date:0310793837 12.02.2015 Defer Date: 10.08.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.No.35011/851/2015-PI(Norms) dated June 2016, uploaded at the end of these minutes decided to call for technical information from the firm and deferred the case.

Case No.:285/5/82-

ALC4/2015
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00425/AM16/
RLA File :03/94/040/01092/AM15/
Lic.No/Date:0310793985 19.02.2015 Defer Date:10.08.2016 Decision :Deferred.

Case No.:279/5/82-

ALC4/2015
Party Name:CROWN CHEMICALS PVT.LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00419/AM16/
RLA File :03/94/040/01088/AM15/
Lic.No/Date:0310793983 19.02.2015 Defer Date:10.08.2016 Decision :Deferred.

Case No.:288/5/82-

ALC4/2015
Party Name:CROWN CHEMICALS PVT.LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00428/AM16/
RLA File :03/94/040/01089/AM15/
Lic.No/Date:0310793982 19.02.2015 Defer Date:10.08.2016 Decision :Deferred.

Case No.:335/5/82-

ALC4/2015
Party Name:PRIVI ORGANICS LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00475/AM16/
RLA File :03/95/040/00978/AM15/
Lic.No/Date:0310794038 20.02.2015 Defer Date:10.08.2016 Decision :Deferred.

Case No.:334/5/82-

ALC4/2015
Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00474/AM16/
RLA File :03/95/040/00862/AM15/
Lic.No/Date:0310794100 24.02.2015 Defer Date:18.06.2016

Decision :Deferred.

Case No.:309/5/82-

ALC4/2015
Party Name:SHREE VALLABH CHEMICAL Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00449/AM16/
RLA File :08/24/040/00417/AM15/
Lic.No/Date:0810134670 25.02.2015 Defer Date:10.08.2016 Decision :Deferred.

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

Party Name:PARAMOUNT AROMACHEM PVT.LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/00001/AM16/
RLA File :05/24/040/00563/AM15/
Lic.No/Date:0510393385 26.02.2015 Defer Date: Decision : The Committee decided to ratify norms repeat basis based on the earlier decision taken by NC in its meeting No.11 dated 26.11.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take

Case No.:273/5/82-

ALC4/2015
Party Name:BHARAT SERUMS & VACCINES LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00413/AM16/
RLA File :03/94/040/01055/AM15/
Lic.No/Date:0310794262 27.02.2015 Defer Date:10.08.2016 Decision :Deferred for want of comments fromDBT.

Case No.:452/5/82-

ALC4/2015
Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00592/AM16/
RLA File :03/94/040/01091/AM15/
Lic.No/Date:0310794261 27.02.2015 Defer Date:10.08.2016 Decision :Deferred.

Case No.:295/5/82-

ALC4/2015
Party Name:PROLIFE INDUSTRIES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00435/AM16/
RLA File :08/24/040/00395/AM15/
Lic.No/Date:0810134703 03.03.2015 Defer Date:10.08.2016 Decision :Deferred.

Case No.:303/5/82-

ALC4/2015
Party Name:ASSOCIATED DYESTUFF PVT. LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00443/AM16/
RLA File :08/24/040/00422/AM15/
Lic.No/Date:0810134739 05.03.2015 Defer Date:10.08.2016 Decision :Deferred.

Case No.:300/5/82-

ALC4/2015
Party Name:ADVANCE PETROCHEMICALS LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00440/AM16/
RLA File :08/24/040/00448/AM15/
Lic.No/Date:0810134768 11.03.2015 Defer Date:10.08.2016 Decision :Deferred.

Case No.:447/5/82-

ALC4/2015
Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00587/AM16/
RLA File :03/94/040/01131/AM15/
Lic.No/Date:0310794543 12.03.2015 Defer Date:10.08.2016 Decision :Committee decided to sent copy of application to DoP and deferred the case.

Case No.:45/4/82-ALC4/2015 Party Name:TIDE

INDUSTRIES Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00084/AM16/
RLA File :34/24/040/00325/AM15/
Lic.No/Date:3410041050 16.03.2015 Defer Date:10.08.2016 Decision :Deferred.

Case No.:291/5/82-

ALC4/2015
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00431/AM16/
RLA File :05/23/040/00544/AM15/
Lic.No/Date:0510393616 18.03.2015 Defer Date:10.08.2016 Decision :Deferred

Case No.:183/5/82-

ALC4/2015
Party Name:SPAK ORGOCHEM (INDIA) PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00323/AM16/
RLA File :03/95/040/00964/AM15/
Lic.No/Date:0310794811 23.03.2015 Defer Date:10.08.2016 Decision :Deferred.

Case No.:29/5/82-ALC4/2015 Party Name:ASSOCIATED

DYESTUFF PVT. LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00169/AM16/
RLA File :08/24/040/00483/AM15/
Lic.No/Date:0810134917 25.03.2015 Defer Date:10.08.2016 Decision :Deferred.

Case No.:16/5/82-ALC4/2015 Party Name:ARENE LIFE

SCIENCES LIMITED. Meet No/Date:7/82- ALC4/2016 07.07.2016 Rejected HQ File :01/82/050/00156/AM16/
RLA File :09/24/040/00736/AM15/
Lic.No/Date:0910061856 31.03.2015 Defer Date:
Decision : The Committee observed that information has been called for from the firm

in NC meeting dated 18.11.2015 and 16.12.2015 but reply has not been received so far.
In absence of these information norms cannot be ratified. The Committee accordingly, decided to reject the case.

Case No.:26/5/82-ALC4/2015 Party Name:CONTINENTAL

CHEMICALS Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00166/AM16/
RLA File :08/24/040/00470/AM15/
Lic.No/Date:0810134992 07.04.2015 Defer Date:10.08.2016 Decision :Deferred.

Case No.:411/5/82-ALC4/2015 Party Name:SHALINA

LABORATORIES PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Rejected HQ File :01/82/050/00551/AM16/
RLA File :03/95/040/01033/AM15/
Lic.No/Date:0310795186 08.04.2015 Defer Date:
Decision : The Committee observed that technical information has been called for from the firm in NC meeting dated 16.12.2015 and 14.01.2016 but reply has not been received so far. In absence of these information norms cannot be ratified. The Committee accordingly, decided to reject the case.

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

Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:7/82- ALC4/2016 07.07.2016 Rejected HQ File :01/82/050/00145/AM16/
RLA File :08/24/040/00003/AM16/
Lic.No/Date:0810135051 17.04.2015 Defer Date:
Decision : The Committee observed that technical information has been called for from the firm by NC meeting dated 18.11.2015 but reply has not been received so far. In absence of these information norms cannot be ratified. The Committee accordingly, decided to reject the case.

Case No.:35/5/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00175/AM16/
RLA File :09/24/040/00739/AM15/
Lic.No/Date:0910061891 17.04.2015 Defer Date:10.08.2016 Decision :The Committee decided to call for a complete set of application from the firm and defer the case.

Case No.:132/7/82-

ALC4/2015
Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 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:10.08.2016 Pharmaceuticals vide O.M.No.35011/617/2015-PI(Norms) dated 21.03.2016, uploaded at the end of these minutes decided to call for technical information from the firm and deferred the case.

Case No.:153/7/82-ALC4/2015 Party Name:DR. ACHARYA

LABORATORIES PVT. LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/00758/AM16/
RLA File :03/94/040/00039/AM16/
Lic.No/Date:0310795534 24.04.2015 Defer Date
Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC for the same export product in its meeting No.08/82 dated 25.09.2014 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No.:29/7/82-ALC4/2015 Party Name:NUTRA

SPECIALITIES PVT. LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Rejected HQ File :01/82/050/00634/AM16/
RLA File :04/24/040/00003/AM16/
Lic.No/Date:0410160438 24.04.2015 Defer Date:
Decision : The Committee observed that technical information has been called from the firm NC meeting dated 16.12.2015 but reply has not been received so far. In absence of these information norms cannot be ratified. The Committee accordingly, decided to reject the case.

Case No.:40/8/82-ALC4/2015 Party Name:SYNTHO

CHIRALS PVT. LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00836/AM16/
RLA File :09/24/040/00042/AM16/
Lic.No/Date:0910061937 27.04.2015 Defer Date:10.08.2016 Decision :Deferred.

Case No.:174/5/82-

ALC4/2015
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00314/AM16/
RLA File :07/24/040/00393/AM15/
Lic.No/Date:0710108142 01.05.2015 Defer Date:10.08.2016 Decision :Deferred.

Case No.:176/5/82-

ALC4/2015
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00316/AM16/
RLA File :07/24/040/00389/AM15/
Lic.No/Date:0710108141 01.05.2015 Defer Date:10.08.2016 Decision :Deferred.

Case No.:177/5/82-

ALC4/2015
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00317/AM16/
RLA File :07/24/040/00390/AM15/
Lic.No/Date:0710108143 01.05.2015 Defer Date:10.08.2016

Decision :Deferred.

Case No.:75/8/82-ALC4/2015 Party Name:PORUS

LABORATORIES PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00871/AM16/
RLA File :09/24/040/00051/AM16/
Lic.No/Date:0910061986 06.05.2015 Defer Date:10.08.2016 Decision : The Committee noted that Information has been called for from the firm in NC meeting No.20 dated 09.03.2016 is awaited. The Committee accordingly deferred the case.

Case No.:65/8/82-ALC4/2015 Party Name:VIRCHOW

BIOTECH PV T LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00861/AM16/
RLA File :09/24/040/00052/AM16/
Lic.No/Date:0910061973 06.05.2015 Defer Date:10.08.2016 Decision :The Committee noted that Information has been called for from the firm in NC meeting No.03 dated 12.05.2016 is awaited. The Committee accordingly deferred the case.

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

PVT.LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00147/AM16/
RLA File :05/23/040/00037/AM16/
Lic.No/Date:0510394177 08.05.2015 Defer Date:08.06.2016 Decision : The Committee noted that Information has been called for from the firm in NC meeting No.03 dated 12.05.2016 is awaited. The Committee accordingly deferred the case.

Case No.:38/8/82-ALC4/2015 Party Name:OPTIMUS DRUGS

PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Rejected HQ File :01/82/050/00834/AM16/
RLA File :09/24/040/00060/AM16/
Lic.No/Date:0910061998 08.05.2015 Defer Date:
Decision : The Committee observed that technical information has been called for from the firm by NC in its meeting dated 16.12.2015 but reply has not been received so far. In absence of these information norms cannot be ratified. The Committee accordingly, decided to reject the case.

Case No.:200/5/82-ALC4/2015 Party Name:SHASUN

PHARMACEUTICALS LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Rejected HQ File :01/82/050/00340/AM16/
RLA File :04/24/040/00038/AM16/
Lic.No/Date:0410160569 21.05.2015 Defer Date:
Decision : The Committee observed that technical information has been called for from the firm by NC in its meeting dated 18.11.2015 &16.12.2015 but reply has not been received so far. In absence of these information norms cannot be ratified. The Committee accordingly, decided to reject the case.

Case No.:97/8/82-ALC4/2015 Party Name:ASCENT

FINECHEM PVT. LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00893/AM16/
RLA File :08/24/040/00051/AM16/
Lic.No/Date:0810135338 22.05.2015 Defer Date:10.08.2016 Decision :Deferred.

Case No.:45/8/82-ALC4/2015 Party Name:MOREPEN

LABORATORIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00841/AM16/
RLA File :05/24/040/00073/AM16/
Lic.No/Date:0510394342 25.05.2015 Defer Date:10.08.2016 Decision : The Committee noted that Information has been called for from the firm in NC meeting No.20 dated 09.03.2016 is awaited. The Committee accordingly deferred the case.

100

Case No.:86/8/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00882/AM16/
RLA File :09/24/040/00131/AM16/
Lic.No/Date:0910062091 29.05.2015 Defer Date:10.08.2016 Decision :Deferred.

101

Case No.:187/7/82-

ALC4/2015
Party Name:ATUL LIMITED, Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00792/AM16/
RLA File :08/24/040/00057/AM16/
Lic.No/Date:0810135435 05.06.2015 Defer Date:10.08.2016 Decision :Deferred.

102

Case No.:121/8/82-

ALC4/2015
Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00917/AM16/
RLA File :03/95/040/00190/AM16/
Lic.No/Date:0310796766 23.06.2015 Defer Date:10.08.2016 Decision :Deferred.

103

Case No.:41/7/82-

ALC4/2016
Party Name:DEEPAK NITRITE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00215/AM17/
RLA File :34/24/040/00082/AM16/
Lic.No/Date:3410041319 24.06.2015 Defer Date: 10.08.2016 Decision :Deferred.

104

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

PETROCHEMICALS LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred

HQ File :01/82/050/00694/AM16/
RLA File :02/24/040/00045/AM16/
Lic.No/Date:0210205925 26.06.2015 Defer Date:10.08.2016 Decision :Deferred.

105

Case No.:5/6/82-ALC4/2015

Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/00601/AM16/
RLA File :34/24/040/00091/AM16/
Lic.No/Date:3410041336 01.07.2015 Defer Date:
Decision : The Committee decided to ratify norms repeat basis based on the earlier decision taken by NC in its meeting No.11 dated 26.11.2014 for same firm, 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.

106

Case No.:97/14/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01233/AM16/
RLA File :09/24/040/00186/AM16/
Lic.No/Date:0910062271 01.07.2015 Defer Date:10.08.2016 Decision :Deferred.

107

Case No.:109/14/82-

ALC4/2015
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01245/AM16/
RLA File :09/24/040/00195/AM16/
Lic.No/Date:0910062283 02.07.2015 Defer Date:10.08.2016 Decision :The committee decided to send copy of application to DoP and deferred the case.

108

Case No.:54/8/82-ALC4/2015 Party Name:JODAS EXPOIM

PVT.LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00850/AM16/
RLA File :05/23/040/00150/AM16/
Lic.No/Date:0510394862 09.07.2015 Defer Date:08.06.2016 Decision : The Committee noted that Information has been called for from the firm in NC meeting No.03 dated 12.05.2016 is awaited. The Committee accordingly deferred the case.

109

Case No.:50/8/82-ALC4/2015 Party Name:PUSILIN

BIOTECHNOLOGY PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00846/AM16/
RLA File :06/24/040/00014/AM16/
Lic.No/Date:0610038189 09.07.2015 Defer Date:10.08.2016 Decision :Deferred for want of comments from DBY.

110

Case No.:54/14/82-

ALC4/2015
Party Name:BIOLOGICAL E LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred

HQ File :01/82/050/01190/AM16/
RLA File :09/24/040/00524/AM15/
Lic.No/Date:0910062332 15.07.2015 Defer Date:10.08.2016 Decision :Deferred.

111

Case No.:59/14/82-

ALC4/2015
Party Name:BIOLOGICAL E LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01195/AM16/
RLA File :09/24/040/00525/AM15/
Lic.No/Date:0910062331 15.07.2015 Defer Date:10.08.2016 Decision :The Committee noted that information has been called for from the firm in NC meeting No.03 dated 12.05.2016 is awaited. The Committee decided to await the reply and deferred the case.

112

Case No.:41/14/82-

ALC4/2015
Party Name:DEEPAK NITRITE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01177/AM16/
RLA File :34/24/040/00031/AM16/
Lic.No/Date:3410041376 15.07.2015 Defer Date:10.08.2016 Decision :Deferred.

113

Case No.:49/8/82-ALC4/2015 Party Name:M.L.A.

INDUSTRIES Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00845/AM16/
RLA File :06/24/040/00015/AM16/
Lic.No/Date:0610038193 16.07.2015 Defer Date:10.08.2016 Decision :Deferred.

114

Case No.:120/8/82-

ALC4/2015
Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00916/AM16/
RLA File :03/95/040/00304/AM16/
Lic.No/Date:0310797293 16.07.2015 Defer Date:10.08.2016 Decision :Deferred.

115

Case No.:49/14/82-

ALC4/2015
Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01185/AM16/
RLA File :09/24/040/00205/AM16/
Lic.No/Date:0910062344 17.07.2015 Defer Date:10.08.2016 Decision :Deferred.

116

Case No.:39/14/82-

ALC4/2015
Party Name:JAGSONPAL PHARMACEUTICALS LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deffered HQ File :01/82/050/01175/AM16/
RLA File :05/23/040/00165/AM16/
Lic.No/Date:0510395004 20.07.2015 Defer Date:10.08.2016

Pharmaceuticals vide O.M.No.35011/769/2015-PI(Norms) dated 27.06.2016, uploaded deferred the case.

117

Case No.:21/16/82-

ALC4/2015
Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01341/AM16/
RLA File :09/24/040/00223/AM16/
Lic.No/Date:0910062361 22.07.2015 Defer Date:10.08.2016 meeting No.05 dated 08.06.2016 is awaited. The Committee decided to await the reply

118

Case No.:149/14/82-

ALC4/2015
Party Name:VISION DRUGS PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01285/AM16/
RLA File :09/24/040/00230/AM16/
Lic.No/Date:0910062365 23.07.2015 Defer Date:10.08.2016 meeting No.03 dated 12.05.2016 is awaited. The Committee decided to await the reply

119

Case No.:79/8/82-ALC4/2015 Party Name:SUN

PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00875/AM16/
RLA File :05/24/040/00110/AM16/
Lic.No/Date:0510395084 24.07.2015 Defer Date:10.08.2016

120

Case No.:164/7/82-ALC4/2016 Party Name:AARTI DRUGS

LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/00338/AM17/
RLA File :03/94/040/00321/AM16/
Lic.No/Date:0310797751 28.07.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/175/2016-PI(Norms) dated July, 2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

121

Case No.:1/10/82-ALC4/2015 Party Name:SALICYLATES

& CHEMICALS PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred

HQ File :01/82/050/00957/AM16/
RLA File :09/24/040/00211/AM16/
Lic.No/Date:0910062393 28.07.2015 Defer Date:10.08.2016 Decision :Deferred.

122

Case No.:170/14/82-

ALC4/2015
Party Name:PI INDUSTRIES LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01306/AM16/
RLA File :13/24/040/00015/AM16/
Lic.No/Date:1310047932 29.07.2015 Defer Date:10.08.2016 Decision :Deferred.

123

Case No.:131/14/82-

ALC4/2015
Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01267/AM16/
RLA File :09/24/040/00212/AM16/
Lic.No/Date:0910062413 30.07.2015 Defer Date:10.08.2016 Decision :Deferred.

124

Case No.:60/14/82-

ALC4/2015
Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01196/AM16/
RLA File :09/24/040/00256/AM16/
Lic.No/Date:0910062418 31.07.2015 Defer Date:10.08.2016 Decision :Deferred.

125

Case No.:84/1/82-ALC1/2016 Party Name:CADILA

Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01858/AM16/
RLA File :08/91/040/00210/AM16/
Lic.No/Date:0810135770 03.08.2015 Defer Date:10.08.2016 Decision :Deferred.

126

Case No.:169/14/82-

ALC4/2015
Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01305/AM16/
RLA File :31/83/040/00018/AM16/
Lic.No/Date:3110065573 03.08.2015 Defer Date:10.08.2016 Decision :Deferred.

127

Case No.:17/8/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00813/AM16/
RLA File :09/24/040/00251/AM16/
Lic.No/Date:0910062426 03.08.2015 Defer Date:10.08.2016 Decision :Deferred.

128 Case No.:168/14/82- Party Name:DEEPAK Meet No/Date:7/82- Deferred

ALC4/2015
NOVOCHEM TECHNOLOGIES LTD ALC4/2016 07.07.2016 HQ File :01/82/050/01304/AM16/
RLA File :31/83/040/00024/AM16/
Lic.No/Date:3110065579 04.08.2015 Defer Date:10.08.2016 Decision :Deferred.

129

Case No.:166/13/82-

ALC4/2015
Party Name:PARAMOUNT AROMACHEM PVT.LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Approved HQ File :01/82/050/01129/AM16/
RLA File :05/24/040/00235/AM16/
Lic.No/Date:0510395245 07.08.2015 Defer Date: Decision : The Committee decided to ratify norms repeat basis based on the earlier decision taken by NC in its meeting No.11 dated 26.11.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take

130

Case No.:18/14/82-

ALC4/2015
Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01154/AM16/
RLA File :03/95/040/00317/AM16/
Lic.No/Date:0310798039 10.08.2015 Defer Date:10.08.2016 Decision :Deferred.

131

Case No.:115/16/82-

ALC4/2015
Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deffered HQ File :01/82/050/01435/AM16/
RLA File :03/95/040/00164/AM16/
Lic.No/Date:0310798051 10.08.2015 Defer Date:10.08.2016 Pharmaceuticals vide O.M.No.35011/779/2015-PI(Norms) dated 27.06.2016, uploaded deferred the case.

132

Case No.:23/8/82-ALC4/2015 Party Name:ALPHAMED

FORMULATIONS P LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00819/AM16/
RLA File :09/24/040/00091/AM16/
Lic.No/Date:0910062478 11.08.2015 Defer Date:10.08.2016

133

Case No.:155/14/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01291/AM16/
RLA File :05/24/040/00237/AM16/
Lic.No/Date:0510395271 11.08.2015 Defer Date:10.08.2016

134

Case No.:11/18/82-

ALC4/2015
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01476/AM16/
RLA File :03/95/040/00327/AM16/
Lic.No/Date:0310798117 13.08.2015 Defer Date:10.08.2016 Decision :Deferred.

135

Case No.:34/14/82-

ALC4/2015
Party Name:TRANSPEK INDUSTRY LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01170/AM16/
RLA File :34/24/040/00144/AM16/
Lic.No/Date:3410041464 17.08.2015 Defer Date:10.08.2016 Decision :Deferred.

136

Case No.:99/14/82-

ALC4/2015
Party Name:OPTIMUS Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01235/AM16/
RLA File :09/24/040/00231/AM16/
Lic.No/Date:0910062516 18.08.2015 Defer Date:10.08.2016 meeting No203 dated 09.03.2016 is awaited. The Committee decided to await the reply

137

Case No.:56/13/82-

ALC4/2015
Party Name:PANACEA BIOTEC LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01019/AM16/
RLA File :05/24/040/00183/AM16/
Lic.No/Date:0510395354 18.08.2015 Defer Date:10.08.2016

138

Case No.:154/14/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01290/AM16/
RLA File :05/24/040/00381/AM15/
Lic.No/Date:0510395357 19.08.2015 Defer Date:10.08.2016 Decision :Deferred.

139

Case No.:68/14/82-

ALC4/2015
& CHEMICALS PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01204/AM16/
RLA File :09/24/040/00368/AM15/
Lic.No/Date:0910062518 19.08.2015 Defer Date:10.08.2016

Decision :Deferred.

140

Case No.:30/14/82-

ALC4/2015
Party Name:BHARAT PARENTERALS LTD, Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Approved HQ File :01/82/050/01166/AM16/
RLA File :34/24/040/00143/AM16/
Lic.No/Date:3410041467 20.08.2015 Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/770/2015-PI(Norms) dated 27.06.2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

141

Case No.:3/14/82-ALC4/2015 Party Name:SHIRDI

CHEMICALS PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: approved HQ File :01/82/050/01139/AM16/
RLA File :03/95/040/00401/AM16/
Lic.No/Date:0310798433 25.08.2015 Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of C&PC forwarded vide U.O.No.14010/105/2011-Ch-II dated 30.09.2015 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP

142

Case No.:24/14/82-

ALC4/2015
Party Name:SHUBHAM SPECIALTY PRODUCTS Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01160/AM16/
RLA File :03/95/040/00348/AM16/
Lic.No/Date:0310798516 27.08.2015 Defer Date:10.08.2016 Decision :Deferred.

143

Case No.:35/14/82-ALC4/2015 Party Name:VENUS

REMEDIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/01171/AM16/
RLA File :22/24/040/00032/AM16/
Lic.No/Date:2210015295 27.08.2015 Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/767/2015-PI(Norms) dated 28.06.2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

144

Case No.:82/14/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01218/AM16/
RLA File :05/24/040/00233/AM16/
Lic.No/Date:0510395480 31.08.2015 Defer Date:10.08.2016

Decision :Deferred.

145

Case No.:89/14/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01225/AM16/
RLA File :05/24/040/00224/AM16/
Lic.No/Date:0510395479 31.08.2015 Defer Date:10.08.2016 Decision :Deferred.

146

Case No.:94/14/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01230/AM16/
RLA File :05/24/040/00202/AM16/
Lic.No/Date:0510395481 31.08.2015 Defer Date:10.08.2016 Decision :Deferred.

147

Case No.:116/16/82-

ALC4/2015
Party Name:PANERA BIOTEC PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01436/AM16/
RLA File :05/24/040/00181/AM16/
Lic.No/Date:0510395496 01.09.2015 Defer Date:10.08.2016 Decision :Deferred for want of comments from DBT.

148

Case No.:93/14/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01229/AM16/
RLA File :05/24/040/00244/AM16/
Lic.No/Date:0510395493 01.09.2015 Defer Date:10.08.2016 meeting No.05 dated 08.06.2016 is awaited. The Committee decided to await the reply

149

Case No.:124/7/82-

ALC4/2016
Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00298/AM17/
RLA File :03/94/040/00424/AM16/
Lic.No/Date:0310798671 04.09.2015 Defer Date:10.08.2016

150

Case No.:5/18/82-ALC4/2015 Party Name:AMI ORGANICS

PVT LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01470/AM16/
RLA File :52/24/040/00039/AM16/
Lic.No/Date:5210041625 04.09.2015 Defer Date:10.08.2016 Decision :Deferred.

151

Case No.:141/14/82-

ALC4/2015
Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01277/AM16/
RLA File :17/24/040/00050/AM16/
Lic.No/Date:1710006170 04.09.2015 Defer Date:10.08.2016 Decision :Deferred.

152

Case No.:52/14/82-

ALC4/2015
Party Name:OPTIMUS Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01188/AM16/
RLA File :09/24/040/00323/AM16/
Lic.No/Date:0910062554 04.09.2015 Defer Date:10.08.2016

153

Case No.:10/20/82-ALC4/2015 Party Name:U SQUARE

LIFESCIENCE PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Approved HQ File :01/82/050/01593/AM16/
RLA File :08/24/040/00153/AM16/
Lic.No/Date:0810135975 04.09.2015 Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/816/2015-PI(Norms) dated June 2016, uploaded

154

Case No.:119/16/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Approved HQ File :01/82/050/01439/AM16/
RLA File :03/94/040/00402/AM16/
Lic.No/Date:0310798725 08.09.2015 Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/774/2015-PI(Norms) dated 05.07.2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

155

Case No.:56/14/82-

ALC4/2015
& CHEMICALS PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01192/AM16/
RLA File :09/24/040/00134/AM16/
Lic.No/Date:0910062560 08.09.2015 Defer Date:10.08.2016 Decision :Deferred

156

Case No.:124/16/82-

ALC4/2015
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred

HQ File :01/82/050/01444/AM16/
RLA File :03/94/040/00399/AM16/
Lic.No/Date:0310798771 09.09.2015 Defer Date:10.08.2016 Decision :Deferred.

157

Case No.:46/14/82-

ALC4/2015
Party Name:MALWA OXYGEN & INDUSTRIAL GASES PVT.LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01182/AM16/
RLA File :56/24/040/00005/AM16/
Lic.No/Date:5610004674 09.09.2015 Defer Date:10.08.2016 Decision :Deferred.

158

Case No.:53/14/82-

ALC4/2015
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01189/AM16/
RLA File :09/24/040/00315/AM16/
Lic.No/Date:0910062581 09.09.2015 Defer Date:08.06.2016

159

Case No.:157/14/82-

ALC4/2015
Party Name:AETHER INDUSTRIES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01293/AM16/
RLA File :52/24/040/00042/AM16/
Lic.No/Date:5210041630 10.09.2015 Defer Date:10.08.2016 Decision :Deferred

160

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

Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01329/AM16/
RLA File :09/24/040/00328/AM16/
Lic.No/Date:0910062593 11.09.2015 Defer Date:10.08.2016 meeting No.05 dated 08.06.2016 is awaited. The Committee decided to await the reply

161

Case No.:56/16/82-

ALC4/2015
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01376/AM16/
RLA File :03/94/040/00435/AM16/
Lic.No/Date:0310798876 14.09.2015 Defer Date:10.08.2016 Decision :Deferred

162

Case No.:8/14/82-ALC4/2015 Party Name:PRIVI

ORGANICS LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01144/AM16/
RLA File :03/95/040/00343/AM16/
Lic.No/Date:0310798846 14.09.2015 Defer Date:10.08.2016

Decision :Deferred.

163

Case No.:110/14/82-

ALC4/2015
& CHEMICALS PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01246/AM16/
RLA File :09/24/040/00305/AM16/
Lic.No/Date:0910062601 14.09.2015 Defer Date:10.08.2016 Decision :Deferred.

164

Case No.:134/14/82-

ALC4/2015
& CHEMICALS PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01270/AM16/
RLA File :09/24/040/00273/AM16/
Lic.No/Date:0910062602 14.09.2015 Defer Date:10.08.2016 Decision :Deferred.

165

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

LABORATORIES PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deffered HQ File :01/82/050/01143/AM16/
RLA File :03/95/040/00426/AM16/
Lic.No/Date:0310798872 14.09.2015 Defer Date:10.08.2016 Pharmaceuticals vide O.M.No.35011/779/2015-PI(Norms) dated 27.06.2016, uploaded deferred the case.

166

Case No.:74/14/82-

ALC4/2015
Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01210/AM16/
RLA File :34/24/040/00120/AM16/
Lic.No/Date:3410041510 15.09.2015 Defer Date:10.08.2016 Decision :Deferred.

167

Case No.:15/14/82-

ALC4/2015
Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01151/AM16/
RLA File :03/95/040/00360/AM16/
Lic.No/Date:0310798909 15.09.2015 Defer Date:10.08.2016 Decision :Deferred.

168

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

VITAMINS PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01145/AM16/
RLA File :03/95/040/00434/AM16/
Lic.No/Date:0310798944 16.09.2015 Defer Date:10.08.2016 Decision :Deferred.

169

Case No.:124/14/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01260/AM16/
RLA File :09/24/040/00355/AM16/
Lic.No/Date:0910062622 16.09.2015 Defer Date:10.08.2016 Decision :Deferred.

170

Case No.:35/16/82-

ALC4/2015
Party Name:D. R. COATS INK & RESINS PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01355/AM16/
RLA File :03/94/040/00415/AM16/
Lic.No/Date:0310798977 21.09.2015 Defer Date:10.08.2016 Decision :Deferred.

171

Case No.:34/16/82-

ALC4/2015
Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01354/AM16/
RLA File :03/94/040/00472/AM16/
Lic.No/Date:0310798979 21.09.2015 Defer Date:10.08.2016

172

Case No.:71/14/82-ALC4/2015 Party Name:MYLAN

LABORATORIES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/01207/AM16/
RLA File :09/24/040/00376/AM16/
Lic.No/Date:0910062633 21.09.2015 Defer Date:
Decision :This case already approved in NC meeting No.05/82 dated 08.06.2016

173

Case No.:64/21/82-

ALC4/2015
Party Name:CADILA HEALTHCARE LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01769/AM16/
RLA File :08/24/040/00137/AM16/
Lic.No/Date:0810136085 22.09.2015 Defer Date:10.08.2016 Decision :The Committee decided to send copy of application to DoP and deferred the case.

174

Case No.:64/14/82-

ALC4/2015
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01200/AM16/
RLA File :09/24/040/00375/AM16/
Lic.No/Date:0910062644 22.09.2015 Defer Date:10.08.2016 meeting No.20 dated 09.03.2016 is awaited. The Committee decided to await the reply

175

Case No.:117/14/82-

ALC4/2015
Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Deferred
HQ File :01/82/050/01253/AM16/
RLA File :04/24/040/00140/AM16/
Lic.No/Date:0410161044 22.09.2015 Defer Date:10.08.2016 Pharmaceuticals vide O.M.No.35011/776/2015-PI(Norms) dated June 2016, uploaded deferred the case.

176

Case No.:118/14/82-

ALC4/2015
Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deffered HQ File :01/82/050/01254/AM16/
RLA File :04/24/040/00139/AM16/
Lic.No/Date:0410161045 22.09.2015 Defer Date:10.08.2016 Pharmaceuticals vide O.M.No.35011/776/2015-PI(Norms) dated June 2016, uploaded deferred the case.

177

Case No.:103/14/82-

ALC4/2015
Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01239/AM16/
RLA File :09/24/040/00362/AM16/
Lic.No/Date:0910062635 22.09.2015 Defer Date:10.08.2016

178

Case No.:25/20/82-

ALC4/2015
Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01608/AM16/
RLA File :13/24/040/00027/AM16/
Lic.No/Date:1310047981 23.09.2015 Defer Date:10.08.2016

179

Case No.:106/14/82-

ALC4/2015
Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01242/AM16/
RLA File :09/24/040/00373/AM16/
Lic.No/Date:0910062649 23.09.2015 Defer Date:10.08.2016

180 Case No.:91/14/82- ALC4/2015
Party Name:CURETECH SKINCARE Meet No/Date:7/82- ALC4/2016 Status:Deffered

07.07.2016 HQ File :01/82/050/01227/AM16/
RLA File :22/21/040/00029/AM16/
Lic.No/Date:2210015316 24.09.2015 Defer Date:10.08.2016 Pharmaceuticals vide O.M.No.35011/792/2015-PI(Norms) dated 27th June 2016, uploaded at the end of these minutes decided to call for technical information from the firm and deferred the case.

181

Case No.:5/20/82-ALC4/2015 Party Name:DORF-KETAL

CHEMICALS INDIA PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Approved HQ File :01/82/050/01588/AM16/
RLA File :03/94/040/00471/AM16/
Lic.No/Date:0310799047 24.09.2015 Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O. No. 14010/176/2011-Ch-II dated 15.12.2015, 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.

182

Case No.:86/14/82-

ALC4/2015
Party Name:BELLAPREMIER HAPPY HYGIENECARE PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01222/AM16/
RLA File :35/24/040/00005/AM16/
Lic.No/Date:3510044794 25.09.2015 Defer Date:10.08.2016 Decision :Deferred.

183

Case No.:8/16/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01328/AM16/
RLA File :09/24/040/00294/AM16/
Lic.No/Date:0910062666 28.09.2015 Defer Date:10.08.2016 Decision :Deferred.

184

Case No.:79/14/82-

ALC4/2015
Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01215/AM16/
RLA File :05/23/040/00274/AM16/
Lic.No/Date:0510395773 30.09.2015 Defer Date:10.08.2016 Decision :Deferred for want of comments from AYUSH.

185

Case No.:69/16/82-

ALC4/2015
Party Name:PIDILITE INDUSTRIES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01389/AM16/
RLA File :03/95/040/00350/AM15/
Lic.No/Date:0310799113 30.09.2015 Defer Date:10.08.2016 Decision :Deferred.

186

Case No.:33/16/82-

ALC4/2015
Party Name:BLISS INDASI LIFESCIENCES PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Approved HQ File :01/82/050/01353/AM16/
RLA File :03/94/040/00483/AM16/
Lic.No/Date:0310799128 01.10.2015 Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/787/2015-PI(Norms) dated 14.06.2016,

187

Case No.:55/16/82-ALC4/2015 Party Name:DORF-KETAL

CHEMICALS INDIA PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/01375/AM16/
RLA File :03/94/040/00525/AM16/
Lic.No/Date:0310799188 05.10.2015 Defer Date:
taken by NC for same export product of same firm in its meeting No.13/82 dated 19.12.2014,

188

Case No.:43/16/82-

ALC4/2015
Party Name:INDOFIL INDUSTRIES LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01363/AM16/
RLA File :03/94/040/00423/AM16/
Lic.No/Date:0310799184 05.10.2015 Defer Date:10.08.2016 Decision :Deferred.

189

Case No.:67/16/82-

ALC4/2015
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01387/AM16/
RLA File :03/95/040/00485/AM16/
Lic.No/Date:0310799241 06.10.2015 Defer Date:10.08.2016 Decision :Deferred.

190

Case No.:139/14/82-

ALC4/2015
Party Name:MAMTA POLYCOATS Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01275/AM16/
RLA File :34/24/040/00178/AM16/
Lic.No/Date:3410041581 08.10.2015 Defer Date:10.08.2016 Decision :Deferred.

191

Case No.:126/16/82-

ALC4/2015
Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01446/AM16/
RLA File :03/95/040/00445/AM16/
Lic.No/Date:0310799287 08.10.2015 Defer Date:10.08.2016 Decision :Deferred.

192

Case No.:61/16/82-

ALC4/2015
Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deffered HQ File :01/82/050/01381/AM16/
RLA File :03/95/040/00483/AM16/
Lic.No/Date:0310799284 08.10.2015 Defer Date:10.08.2016 Pharmaceuticals vide O.M.No.35011/779/2015-PI(Norms) dated 27.06.2016, uploaded deferred the case.

193

Case No.:62/16/82-

ALC4/2015
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01382/AM16/
RLA File :03/95/040/00491/AM16/
Lic.No/Date:0310799292 08.10.2015 Defer Date:10.08.2016 Decision :Deferred.

194

Case No.:17/16/82-

ALC4/2015
Party Name:VISION DRUGS PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01337/AM16/
RLA File :09/24/040/00402/AM16/
Lic.No/Date:0910062693 08.10.2015 Defer Date:10.08.2016 Decision : : The Committee noted that information has been called for from the firm in NC meeting No.03 dated 12.05.2016 is awaited. The Committee decided to await the reply and deferred the case.

195

Case No.:164/14/82-

ALC4/2015
Party Name:AASHA BIOCHEM Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01300/AM16/
RLA File :10/24/040/00049/AM16/
Lic.No/Date:1010059293 12.10.2015 Defer Date:10.08.2016 meeting No.05 dated 08.06.2016 is awaited. The Committee decided to await the reply

196

Case No.:140/14/82-

ALC4/2015
Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01276/AM16/
RLA File :34/24/040/00175/AM16/
Lic.No/Date:3410041586 12.10.2015 Defer Date:10.08.2016 Decision :Deferred.

197

Case No.:144/14/82-

ALC4/2015
Party Name:AMI ORGANICS PVT LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01280/AM16/
RLA File :52/24/040/00049/AM16/
Lic.No/Date:5210041658 14.10.2015 Defer Date:10.08.2016

Decision :Deferred.

198

Case No.:58/16/82-

ALC4/2015
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01378/AM16/
RLA File :03/94/040/00497/AM16/
Lic.No/Date:0310799433 14.10.2015 Defer Date:10.08.2016 meeting No.05 dated 08.06.2016 is awaited. The Committee decided to await the reply

199

Case No.:132/14/82-

ALC4/2015
Party Name:RIDDHI PHARMA Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01268/AM16/
RLA File :34/24/040/00180/AM16/
Lic.No/Date:3410041592 14.10.2015 Defer Date:10.08.2016 Decision :Deferred.

200

Case No.:60/16/82-

ALC4/2015
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01380/AM16/
RLA File :03/94/040/00486/AM16/
Lic.No/Date:0310799460 15.10.2015 Defer Date:10.08.2016

201

Case No.:92/16/82-

ALC4/2015
Party Name:TRANSPEK INDUSTRY LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01412/AM16/
RLA File :34/24/040/00185/AM16/
Lic.No/Date:3410041600 15.10.2015 Defer Date:10.08.2016

202

Case No.:158/14/82-

ALC4/2015
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/01294/AM16/
RLA File :05/23/040/00305/AM16/
Lic.No/Date:0510395945 16.10.2015 Defer Date:
Pharmaceuticals forwarded vide O.M. No. 35011/789/2015-PI(Norms) dated 18.07.2016,

203

Case No.:72/16/82-

ALC4/2015
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01392/AM16/
RLA File :03/95/040/00102/AM16/
Lic.No/Date:0310799579 21.10.2015 Defer Date:10.08.2016

Decision :Deferred.

204

Case No.:73/16/82-

ALC4/2015
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01393/AM16/
RLA File :03/95/040/00087/AM16/
Lic.No/Date:0310799578 21.10.2015 Defer Date:10.08.2016 Decision :Deferred.

205

Case No.:29/16/82-

ALC4/2015
& CHEMICALS PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01349/AM16/
RLA File :09/24/040/00379/AM16/
Lic.No/Date:0910062768 23.10.2015 Defer Date:10.08.2016 Decision :Deferred.

206

Case No.:30/16/82-

ALC4/2015
& CHEMICALS PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01350/AM16/
RLA File :09/24/040/00383/AM16/
Lic.No/Date:0910062767 23.10.2015 Defer Date:10.08.2016 Decision :Deferred.

207

Case No.:129/16/82-

ALC4/2015
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01449/AM16/
RLA File :03/95/040/00505/AM16/
Lic.No/Date:0310799628 23.10.2015 Defer Date:10.08.2016 Decision :Deferred.

208

Case No.:161/14/82-

ALC4/2015
Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01297/AM16/
RLA File :03/94/040/01226/AM15/
Lic.No/Date:0310799680 26.10.2015 Defer Date:10.08.2016 Decision :Deferred.

209

Case No.:78/16/82-

ALC4/2015
Party Name:MOHINI ORGANICS PVT. LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01398/AM16/
RLA File :03/95/040/00777/AM15/
Lic.No/Date:0310799666 26.10.2015 Defer Date:10.08.2016 Decision :Deferred.

210

Case No.:53/20/82-

ALC4/2015
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred

HQ File :01/82/050/01636/AM16/
RLA File :03/95/040/00529/AM16/
Lic.No/Date:0310799675 26.10.2015 Defer Date:10.08.2016 Decision :Deferred.

21 1

Case No.:93/16/82-

ALC4/2015
Party Name:JAINEX SPECIALITY CHEMIC AL Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01413/AM1 6/
RLA File :34/24/040/00196/AM16/
Lic.No/Date:34100416 26 28.10.2015 Defer Date:10.08.201 6 Decision :Deferred.

212

Case No.:31/16/82-

ALC4/2015
Party Name:MSN LABORATORIES PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01351/AM16/
RLA File :09/24/040/00423/AM16/
Lic.No/Date:0910062790 28.10.2015 Defer Date:10.08.2016 meeting No.03 dated 08.06.2016 is awaited. The Committee decided to await the reply

213

Case No.:74/16/82-

ALC4/2015
Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01394/AM16/
RLA File :03/95/040/00518/AM16/
Lic.No/Date:0310799705 28.10.2015 Defer Date:10.08.2016 Decision :Deferred

214

Case No.:75/16/82-

ALC4/2015
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01395/AM16/
RLA File :03/95/040/00525/AM16/
Lic.No/Date:0310799704 28.10.2015 Defer Date:10.08.2016 Decision :Defered.

215

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

LIFESCIENCE PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Approved HQ File :01/82/050/01592/AM16/
RLA File :08/24/040/00237/AM16/
Lic.No/Date:0810136380 28.10.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/816/2015-PI(Norms) dated June 2016, uploaded

216

Case No.:47/16/82-

ALC4/2015
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred

HQ File :01/82/050/01367/AM16/
RLA File :03/95/040/00526/AM16/
Lic.No/Date:0310799853 29.10.2015 Defer Date:10.08.2016 Decision :Deferred.

217

Case No.:136/14/82-

ALC4/2015
Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01272/AM16/
RLA File :05/23/040/00293/AM16/
Lic.No/Date:0510396078 30.10.2015 Defer Date:10.08.2016 Decision : Information called for from the firm in NC meeting No.03/AM17 is awaited and deferred the case.

218

Case No.:48/16/82-ALC4/2015 Party Name:O C

SPECIALITIES PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:
Deferred HQ File :01/82/050/01368/AM16/
RLA File :03/95/040/00549/AM16/
Lic.No/Date:0310799873 30.10.2015 Defer Date: 10.08.2016 Decision : Deferred.

219

Case No.:87/16/82-ALC4/2015 Party Name:SCOTT-EDIL

PHARMACIA LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/01407/AM16/
RLA File :22/24/040/00020/AM16/
Lic.No/Date:2210015341 30.10.2015 Defer Date:
Pharmaceuticals forwarded vide O.M. No. 35011/788/2015-PI(Norms) dated 14.07.2016,

220

Case No.:159/14/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01295/AM16/
RLA File :05/24/040/00343/AM16/
Lic.No/Date:0510396075 30.10.2015 Defer Date:10.08.2016 Decision : Information called for from the firm in NC meeting No.03/AM17 is awaited. The committee accordingly deferred the case.

221

Case No.:118/16/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01438/AM16/
RLA File :05/24/040/00345/AM16/
Lic.No/Date:0510396076 30.10.2015 Defer Date:10.08.2016 Decision : Information called for from the firm in NC meeting No.03/AM17 is awaited. The committee accordingly deferred the case.

222

Case No.:84/16/82-ALC4/2015 Party Name:VENUS

REMEDIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Deferred HQ File :01/82/050/01404/AM16/
RLA File :22/24/040/00055/AM16/
Lic.No/Date:2210015339 30.10.2015 Defer Date 10.08.2016 Decision : Information called for from the firm in NC meeting No.03/AM17 is awaited. The committee accordingly deferred the case.

223

Case No.:67/21/82-ALC4/2015 Party Name:CADILA

HEALTHCARE LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/01772/AM16/
RLA File :08/24/040/00258/AM16/
Lic.No/Date:0810136406 02.11.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No. 35011/65/2016-PI(Norms) dated June 2016, uploaded

224

Case No.:112/16/82-

ALC4/2015
Party Name:BELCO PHARMA Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01432/AM16/
RLA File :05/23/040/00273/AM16/
Lic.No/Date:0510396205 03.11.2015 Defer Date:10.08.2016 Decision : Deferred for want of comments from DoP.

225

Case No.:107/16/82-

ALC4/2015
Party Name:HELLO PAINTS (P) LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01427/AM16/
RLA File :05/23/040/00326/AM16/
Lic.No/Date:0510396204 03.11.2015 Defer Date:10.08.2016 Decision :Deferred.

226

Case No.:19/16/82-

ALC4/2015
Party Name:MEDICLONE BIO-TECH PRIVATE LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Approved HQ File :01/82/050/01339/AM16/
RLA File :04/24/040/00181/AM16/
Lic.No/Date:0410161279 04.11.2015 Defer Date:
Pharmaceuticals forwarded vide O.M. No. 35011/799/2015-PI(Norms) dated 18.07.2016,

227

Case No.:90/16/82-

ALC4/2015
Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01410/AM16/
RLA File :34/24/040/00207/AM16/
Lic.No/Date:3410041662 05.11.2015 Defer Date:10.08.2016 Decision :Deferred.

228

Case No.:88/16/82-

ALC4/2015
Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01408/AM16/
RLA File :34/24/040/00202/AM16/
Lic.No/Date:3410041663 05.11.2015 Defer Date:10.08.2016 Decision :Deferred.

229

Case No.:37/16/82-

ALC4/2015
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01357/AM16/
RLA File :03/94/040/00561/AM16/
Lic.No/Date:0310800114 06.11.2015 Defer Date:10.08.2016

230

Case No.:53/16/82-

ALC4/2015
Party Name:LAXMI ORGANIC INDUSTRIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01373/AM16/
RLA File :03/95/040/00540/AM16/
Lic.No/Date:0310800090 06.11.2015 Defer Date:10.08.2016 Decision :Deferred.

231

Case No.:89/16/82-

ALC4/2015
Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01409/AM16/
RLA File :34/24/040/00203/AM16/
Lic.No/Date:3410041666 09.11.2015 Defer Date:10.08.2016 Decision :Deferred.

232

Case No.:2/16/82-ALC4/2015 Party Name:SANO

MEDICAL KITS PVT. LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01322/AM16/
RLA File :04/24/040/00175/AM16/
Lic.No/Date:0410161296 09.11.2015 Defer Date:10.08.2016 Decision : Information called for from the firm in NC meeting No.18/AM16 dated 10.02.2016 is awaited. The committee accordingly deferred the case.

233

Case No.:34/1/82-ALC1/2016 Party Name:GLAND

PHARMA LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01808/AM16/
RLA File :09/24/040/00469/AM16/
Lic.No/Date:0910062848 10.11.2015 Defer Date:10.08.2016

234

Case No.:114/16/82-

ALC4/2015
Party Name:SHIVA BIOCHEM INDUSTRIES Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File RLA File Lic.No/Date:5010002240 Defer

:01/82/050/01434/AM16/
:50/24/040/00017/AM16/
16.11.2015 Date:10.08.2016 Decision :Deferred.

235

Case No.:52/20/82-

ALC4/2015
Party Name:RELIANCE INDUSTRIES LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01635/AM16/
RLA File :03/95/040/00551/AM16/
Lic.No/Date:0310800331 19.11.2015 Defer Date:10.08.2016 Decision :Deferred.

236

Case No.:104/16/82-

ALC4/2015
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01424/AM16/
RLA File :05/23/040/00339/AM16/
Lic.No/Date:0510396384 20.11.2015 Defer Date:10.08.2016 Decision :Deferred.

237

Case No.:4/20/82-ALC4/2015 Party Name:AIMS IMPEX

PVT. LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01587/AM16/
RLA File :03/94/040/00656/AM16/
Lic.No/Date:0310800363 23.11.2015 Defer Date:10.08.2016 Decision :Deferred.

238

Case No.:31/1/82-ALC1/2016 Party Name:PAYAL

PETROCHEM PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01805/AM16/
RLA File :05/24/040/00347/AM16/
Lic.No/Date:0510396399 23.11.2015 Defer Date:10.08.2016 Decision :Deferred.

239

Case No.:2/20/82-ALC4/2015 Party Name:PCL OIL &

SOLVENTS LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01585/AM16/
RLA File :05/24/040/00400/AM16/
Lic.No/Date:0510396400 23.11.2015 Defer Date:10.08.2016 Decision :Deferred.

240

Case No.:79/16/82-ALC4/2015 Party Name:VENUS

REMEDIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/01399/AM16/
RLA File :22/24/040/00074/AM16/
Lic.No/Date:2210015349 23.11.2015 Defer Date:
Pharmaceuticals forwarded vide O.M. No. 35011/767/2015-PI(Norms) dated 28.06.2016,

241

Case No.:81/16/82-ALC4/2015 Party Name:VENUS

REMEDIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/01401/AM16/
RLA File :22/24/040/00075/AM16/
Lic.No/Date:2210015348 23.11.2015 Defer Date:
Pharmaceuticals forwarded vide O.M. No. 35011/767/2015-PI(Norms) dated 28.06.2016,

242

Case No.:105/16/82-

ALC4/2015
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/01425/AM16/
RLA File :05/23/040/00356/AM16/
Lic.No/Date:0510396410 24.11.2015 Defer Date:
Pharmaceuticals forwarded vide O.M. No. 35011/789/2015-PI(Norms) dated 18.07.2016,

243

Case No.:33/1/82-ALC1/2016 Party Name:INCHEM

LABORATORIES PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deffered HQ File :01/82/050/01807/AM16/
RLA File :09/24/040/00486/AM16/
Lic.No/Date:0910062902 26.11.2015 Defer Date:10.08.2016 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No. 35011/70/2016-PI(Norms) dated June 2016, uploaded at the end of these minutes and deferred the case.

244

Case No.:32/16/82-

ALC4/2015
Party Name:INTERMED, Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01352/AM16/
RLA File :04/24/040/00177/AM16/
Lic.No/Date:0410161343 26.11.2015 Defer Date:10.08.2016 Decision : Information called for from the firm in NC meeting No.05/AM17 dated 08.06.2016 is awaited. The committee accordingly deferred the case.

245

Case No.:2/1/82-ALC1/2016 Party Name:UNIJULES LIFE

SCIENCES LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01776/AM16/
RLA File :03/95/040/00632/AM16/
Lic.No/Date:0310800416 26.11.2015 Defer Date:10.08.2016

246

Case No.:23/1/82-ALC1/2016 Party Name:UNILINK

PHARMA PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred

HQ File :01/82/050/01797/AM16/
RLA File :04/24/040/00170/AM16/
Lic.No/Date:0410161342 26.11.2015 Defer Date:10.08.2016

247

Case No.:58/20/82-

ALC4/2015
Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01641/AM16/
RLA File :03/95/040/00182/AM15/
Lic.No/Date:0310800550 01.12.2015 Defer Date:10.08.2016 Decision :Deferred.

248

Case No.:3/1/82-ALC1/2016 Party Name:NEOGEN

CHEMICALS LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01777/AM16/
RLA File :03/95/040/00529/AM15/
Lic.No/Date:0310800547 01.12.2015 Defer Date:10.08.2016 Decision :Deferred.

249

Case No.:5/1/82-ALC1/2016 Party Name:NEOGEN

CHEMICALS LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01779/AM16/
RLA File :03/95/040/00239/AM15/
Lic.No/Date:0310800551 01.12.2015 Defer Date:10.08.2016 Decision :Deferred.

250

Case No.:33/20/82-

ALC4/2015
Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01616/AM16/
RLA File :03/94/040/00532/AM16/
Lic.No/Date:0310800597 02.12.2015 Defer Date:10.08.2016 Decision :Deferred.

251

Case No.:54/20/82-

ALC4/2015
Party Name:MELOG SPECIALITY CHEMICALS PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01637/AM16/
RLA File :03/95/040/00631/AM16/
Lic.No/Date:0310800619 03.12.2015 Defer Date:10.08.2016 Decision :Deferred.

252

Case No.:112/20/82-

ALC4/2015
Party Name:SUPREET CHEMICALS PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01695/AM16/
RLA File :03/95/040/00646/AM16/
Lic.No/Date:0310800620 03.12.2015 Defer Date:10.08.2016 Decision :Deferred.

253 Case No.:86/20/82- Party Name:REANNON Meet No/Date:7/82- Status:Approved

ALC4/2015
PHARMACEUTICALS ALC4/2016 07.07.2016 HQ File :01/82/050/01669/AM16/
RLA File :03/95/040/00494/AM16/
Lic.No/Date:0310800662 04.12.2015 Defer Date:
Pharmaceuticals forwarded vide O.M. No. 35011/845/2015-PI(Norms) dated 10.06.2016,

254

Case No.:87/20/82-

ALC4/2015
Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01670/AM16/
RLA File :03/95/040/00605/AM16/
Lic.No/Date:0310800715 07.12.2015 Defer Date:10.08.2016

255

Case No.:127/16/82-

ALC4/2015
Party Name:BLUELINE FOODS (INDIA) PVT.LTD, Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01447/AM16/
RLA File :07/24/040/00267/AM16/
Lic.No/Date:0710109146 08.12.2015 Defer Date:10.08.2016 Decision : Information called for from the firm in NC meeting No.03/AM17 dated 12.05.2016 is awaited. The committee accordingly deferred the case.

256

Case No.:36/20/82-

ALC4/2015
Party Name:BAYER VAPI PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01619/AM16/
RLA File :03/94/040/00651/AM16/
Lic.No/Date:0310800833 09.12.2015 Defer Date:10.08.2016 Decision :Deferred.

257

Case No.:67/20/82-

ALC4/2015
Party Name:MANGALAM ORGANICS LIMITED (FORMERLY DUJODWALA Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01650/AM16/
RLA File :03/95/040/00054/AM16/
Lic.No/Date:0310800865 10.12.2015 Defer Date:10.08.2016

258

Case No.:108/20/82-

ALC4/2015
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Approved HQ File :01/82/050/01691/AM16/
RLA File :09/24/040/00506/AM16/
Lic.No/Date:0910062961 10.12.2015 Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/05/2016-PI(Norms) dated 6.6.2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP

259

Case No.:110/20/82-

ALC4/2015
Party Name:PROCESS AGROCHEM INDUSTRIES PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/01693/AM16/
RLA File :56/24/040/00040/AM16/
Lic.No/Date:5610004767 10.12.2015 Defer Date:
Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.07/82 dated 24.07.2015 as details given below or as applied by the firm or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.

Export product Qty. Import items Qty.in kg. Soya Lecithin (Feed Grade) 1kg Liquid lecithin (Non Edible Grade) 1.01

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

260

Case No.:39/20/82-

ALC4/2015
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01622/AM16/
RLA File :03/94/040/00088/AM16/
Lic.No/Date:0310800889 11.12.2015 Defer Date:10.08.2016 Decision :Deferred.

261

Case No.:41/20/82-

ALC4/2015
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01624/AM16/
RLA File :03/94/040/00648/AM16/
Lic.No/Date:0310800905 11.12.2015 Defer Date:10.08.2016 Decision :Deferred.

262

Case No.:9/1/82-ALC1/2016 Party Name:CAMPHOR &

ALLIED PRODUCTS LIMITED, Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01783/AM16/
RLA File :03/94/040/00490/AM16/
Lic.No/Date:0310800912 11.12.2015 Defer Date:10.08.2016 Decision :Deferred.

263

Case No.:66/20/82-

ALC4/2015
Party Name:PRIVI ORGANICS LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01649/AM16/
RLA File :03/95/040/00633/AM16/
Lic.No/Date:0310800935 11.12.2015 Defer Date:10.08.2016 Decision :Deferred.

264

Case No.:45/20/82-

ALC4/2015
Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01628/AM16/
RLA File :03/94/040/00736/AM16/
Lic.No/Date:0310800992 14.12.2015 Defer Date:10.08.2016 Decision :Deferred.

265

Case No.:24/20/82-

ALC4/2015
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01607/AM16/
RLA File :03/95/040/00088/AM16/
Lic.No/Date:0310800991 14.12.2015 Defer Date:10.08.2016 Decision :Deferred.

266

Case No.:49/20/82-

ALC4/2015
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01632/AM16/
RLA File :03/94/040/00714/AM16/
Lic.No/Date:0310801093 16.12.2015 Defer Date:10.08.2016 Decision :Deferred.

267

Case No.:10/1/82-ALC1/2016 Party Name:BENZO CHEM

INDUSTRIES PRIVATE LIMITED, Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01784/AM16/
RLA File :03/94/040/00630/AM16/
Lic.No/Date:0310801130 16.12.2015 Defer Date:10.08.2016 Decision :Deferred.

268

Case No.:44/20/82-ALC4/2015 Party Name:CELOGEN

PHARMA PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Approved HQ File :01/82/050/01627/AM16/
RLA File :03/94/040/00720/AM16/
Lic.No/Date:0310801132 16.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No. 35011/859/2015-PI(Norms) dated 20.06.2016,

269

Case No.:46/20/82-

ALC4/2015
Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01629/AM16/
RLA File :03/94/040/00692/AM16/
Lic.No/Date:0310801111 16.12.2015 Defer Date:10.08.2016

270

Case No.:23/20/82-

ALC4/2015
Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01606/AM16/
RLA File :03/95/040/00697/AM16/
Lic.No/Date:0310801116 16.12.2015 Defer Date:10.08.2016

271 Case No.:8/20/82-ALC4/2015 Party Name:SHREE Meet No/Date:7/82- Deferred

BANKEY BEHARI LAL BOARD MILLS ALC4/2016 07.07.2016 HQ File :01/82/050/01591/AM16/
RLA File :05/24/040/00427/AM16/
Lic.No/Date:0510396637 16.12.2015 Defer Date:10.08.2016

272

Case No.:8/1/82-ALC1/2016 Party Name:CAMPHOR &

ALLIED PRODUCTS LIMITED, Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01782/AM16/
RLA File :03/94/040/00754/AM16/
Lic.No/Date:0310801214 18.12.2015 Defer Date:10.08.2016

273

Case No.:83/1/82-ALC1/2016 Party Name:JINDAL DRUGS

PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01857/AM16/
RLA File :03/94/040/00752/AM16/
Lic.No/Date:0310801211 18.12.2015 Defer Date:10.08.2016

274

Case No.:14/20/82-

ALC4/2015
Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01597/AM16/
RLA File :03/94/040/00728/AM16/
Lic.No/Date:0310801252 21.12.2015 Defer Date:10.08.2016

275

Case No.:15/20/82-

ALC4/2015
Party Name:CELOGEN PHARMA PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Approved HQ File :01/82/050/01598/AM16/
RLA File :03/94/040/00721/AM16/
Lic.No/Date:0310801298 22.12.2015 Defer Date:
Pharmaceuticals forwarded vide O.M. No. 35011/859/2015-PI(Norms) dated 20.06.2016,

276

Case No.:19/20/82-

ALC4/2015
Party Name:LAXMI ORGANIC INDUSTRIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01602/AM16/
RLA File :03/95/040/00009/AM16/
Lic.No/Date:0310801275 22.12.2015 Defer Date:10.08.2016 Decision :Deferred.

277

Case No.:20/20/82-

ALC4/2015
Party Name:LAXMI ORGANIC INDUSTRIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File RLA File Lic.No/Date:0310801273 Defer

:01/82/050/01603/AM16/
:03/95/040/00267/AM16/
22.12.2015 Date:10.08.2016 Decision :Deferred.

278

Case No.:48/20/82-

ALC4/2015
Party Name:ALCHEMIE LABORATORIES Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01631/AM16/
RLA File :03/94/040/00683/AM16/
Lic.No/Date:0310801362 28.12.2015 Defer Date:10.08.2016 Decision :Deferred.

279

Case No.:7/7/82-ALC4/2016 Party Name:CADILA

Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00181/AM17/
RLA File :08/24/040/00333/AM16/
Lic.No/Date:0810136798 29.12.2015 Defer Date:10.08.2016

280

Case No.:80/20/82-

ALC4/2015
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01663/AM16/
RLA File :03/95/040/00736/AM16/
Lic.No/Date:0310801389 29.12.2015 Defer Date:10.08.2016 Decision :Deferred.

281

Case No.:81/20/82-

ALC4/2015
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01664/AM16/
RLA File :03/95/040/00735/AM16/
Lic.No/Date:0310801388 29.12.2015 Defer Date:10.08.2016

282

Case No.:22/20/82-

ALC4/2015
Party Name:S M B CORPORATION OF INDIA Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01605/AM16/
RLA File :03/95/040/00738/AM16/
Lic.No/Date:0310801409 30.12.2015 Defer Date:10.08.2016 Decision :Deferred.

283

Case No.:84/20/82-

ALC4/2015
Party Name:SIRMAXO CHEMICALS PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01667/AM16/
RLA File :03/95/040/00730/AM16/
Lic.No/Date:0310801411 30.12.2015 Defer Date:10.08.2016

284 Case No.:47/20/82- ALC4/2015
Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:7/82- ALC4/2016 Deferred

07.07.2016 HQ File :01/82/050/01630/AM16/
RLA File :03/94/040/00792/AM16/
Lic.No/Date:0310801428 31.12.2015 Defer Date:10.08.2016 Decision :Deferred.

285

Case No.:98/20/82-

ALC4/2015
Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deffered HQ File :01/82/050/01681/AM16/
RLA File :05/23/040/00338/AM16/
Lic.No/Date:0510397164 31.12.2015 Defer Date:10.08.2016 Pharmaceuticals vide O.M.No.35011/68/2016-PI(Norms) dated June 2016, uploaded at the end of these minutes decided to call for technical information from the firm and deferred the case.

286

Case No.:99/20/82-

ALC4/2015
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01682/AM16/
RLA File :05/23/040/00389/AM16/
Lic.No/Date:0510397158 31.12.2015 Defer Date:10.08.2016 Decision :Deferred.

287

Case No.:101/20/82-

ALC4/2015
Party Name:SONGWON SPECIALTY CHEMICALS INDIA PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01684/AM16/
RLA File :34/24/040/00226/AM16/
Lic.No/Date:3410041775 31.12.2015 Defer Date:10.08.2016 Decision :Deferred.

288

Case No.:119/20/82-

ALC4/2015
Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01702/AM16/
RLA File :09/24/040/00582/AM16/
Lic.No/Date:0910063066 31.12.2015 Defer Date:10.08.2016 Decision :Deferred.

289

Case No.:104/20/82-

ALC4/2015
Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01687/AM16/
RLA File :34/24/040/00253/AM16/
Lic.No/Date:3410041778 04.01.2016 Defer Date:10.08.2016 Decision :Deferred.

290

Case No.:82/20/82-

ALC4/2015
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred

HQ File :01/82/050/01665/AM16/
RLA File :03/95/040/00750/AM16/
Lic.No/Date:0310801522 04.01.2016 Defer Date:10.08.2016 Decision :Deferred.

291

Case No.:83/20/82-

ALC4/2015
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01666/AM16/
RLA File :03/95/040/00749/AM16/
Lic.No/Date:0310801521 04.01.2016 Defer Date:10.08.2016 Decision :Deferred.

292

Case No.:105/20/82-

ALC4/2015
Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01688/AM16/
RLA File :34/24/040/00252/AM16/
Lic.No/Date:3410041782 05.01.2016 Defer Date:10.08.2016 Decision :Deferred.

293

Case No.:78/20/82-

ALC4/2015
Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01661/AM16/
RLA File :03/95/040/00652/AM16/
Lic.No/Date:0310801554 05.01.2016 Defer Date:10.08.2016 Decision :Deferred.

294

Case No.:26/20/82-

ALC4/2015
Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01609/AM16/
RLA File :03/94/040/00802/AM16/
Lic.No/Date:0310801601 06.01.2016 Defer Date:10.08.2016 Decision :Deferred.

295

Case No.:7/1/82-ALC1/2016 Party Name:PRIVI

ORGANICS LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01781/AM16/
RLA File :03/95/040/00688/AM16/
Lic.No/Date:0310801600 06.01.2016 Defer Date:10.08.2016 Decision :Deferred.

296

Case No.:76/20/82-

ALC4/2015
Party Name:AIMS IMPEX PVT. LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01659/AM16/
RLA File :03/94/040/00790/AM16/
Lic.No/Date:0310801644 07.01.2016 Defer Date:10.08.2016 Decision :Deferred.

297 Case No.:103/20/82- Party Name:JUBILANT LIFE Meet No/Date:7/82- Deferred

ALC4/2015
SCIENCES LIMITED ALC4/2016 07.07.2016 HQ File :01/82/050/01686/AM16/
RLA File :05/23/040/00404/AM16/
Lic.No/Date:0510397232 07.01.2016 Defer Date:10.08.2016 Decision :Deferred.

298

Case No.:6/1/82-ALC1/2016 Party Name:MEDISPRAY

LABORATORIES PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01780/AM16/
RLA File :03/95/040/00676/AM16/
Lic.No/Date:0310801634 07.01.2016 Defer Date:10.08.2016

299

Case No.:32/1/82-ALC1/2016 Party Name:PAYAL

PETROCHEM PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01806/AM16/
RLA File :05/24/040/00431/AM16/
Lic.No/Date:0510397230 07.01.2016 Defer Date:10.08.2016 Decision :Deferred.

300

Case No.:95/20/82-

ALC4/2015
Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deffered HQ File :01/82/050/01678/AM16/
RLA File :05/24/040/00499/AM16/
Lic.No/Date:0510397256 08.01.2016 Defer Date:10.08.2016 Pharmaceuticals vide O.M.No.35011/850/2015-PI(Norms) dated 10.06..2016, uploaded deferred the case.

301

Case No.:79/20/82-

ALC4/2015
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01662/AM16/
RLA File :03/95/040/00765/AM16/
Lic.No/Date:0310801655 08.01.2016 Defer Date:10.08.2016 Decision :Deferred.

302

Case No.:21/20/82-

ALC4/2015
Party Name:SHREE LIFE SCIENCES PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deffered HQ File :01/82/050/01604/AM16/
RLA File :03/95/040/00762/AM16/
Lic.No/Date:0310801691 11.01.2016 Defer Date:10.08.2016 Pharmaceuticals vide O.M.No.35011/847/2015-PI(Norms) dated 10.06.2016, uploaded

deferred the case.

303

Case No.:19/1/82-ALC1/2016 Party Name:STRIDES

SHASUN LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01793/AM16/
RLA File :04/24/040/00214/AM16/
Lic.No/Date:0410161494 11.01.2016 Defer Date:10.08.2016

304

Case No.:60/1/82-ALC1/2016 Party Name:BDR

PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01834/AM16/
RLA File :03/94/040/00828/AM16/
Lic.No/Date:0310801732 12.01.2016 Defer Date:10.08.2016

305

Case No.:61/1/82-ALC1/2016 Party Name:BDR

PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01835/AM16/
RLA File :03/94/040/00820/AM16/
Lic.No/Date:0310801731 12.01.2016 Defer Date:10.08.2016

306

Case No.:48/1/82-ALC1/2016 Party Name:INDO AMINES

LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01822/AM16/
RLA File :03/94/040/00785/AM16/
Lic.No/Date:0310801728 12.01.2016 Defer Date:10.08.2016

307

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

ORGANICS LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01856/AM16/
RLA File :03/95/040/00690/AM16/
Lic.No/Date:0310801719 12.01.2016 Defer Date:10.08.2016 Decision :Deferred.

308

Case No.:62/1/82-ALC1/2016 Party Name:BDR

PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01836/AM16/
RLA File :03/94/040/00833/AM16/
Lic.No/Date:0310801811 15.01.2016 Defer Date:10.08.2016

309

Case No.:66/1/82-ALC1/2016 Party Name:BTL EXPORTS

PVT. LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01840/AM16/
RLA File :03/94/040/00831/AM16/
Lic.No/Date:0310801850 18.01.2016 Defer Date:10.08.2016

310

Case No.:64/1/82-ALC1/2016 Party Name:ETERNIS FINE

CHEMICALS LIMITED, Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01838/AM16/
RLA File :03/94/040/00840/AM16/
Lic.No/Date:0310801857 18.01.2016 Defer Date:10.08.2016 Decision :Deferred.

311

Case No.:79/1/82-ALC1/2016 Party Name:PRIVI

ORGANICS LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01853/AM16/
RLA File :03/95/040/00689/AM16/
Lic.No/Date:0310801831 18.01.2016 Defer Date:10.08.2016 Decision :Deferred.

312

Case No.:80/1/82-ALC1/2016 Party Name:SUNSHIELD

CHEMICALS LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01854/AM16/
RLA File :03/95/040/00771/AM16/
Lic.No/Date:0310801856 18.01.2016 Defer Date:10.08.2016 Decision :Deferred.

313

Case No.:63/1/82-ALC1/2016 Party Name:BDR

PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01837/AM16/
RLA File :03/94/040/00846/AM16/
Lic.No/Date:0310801882 19.01.2016 Defer Date:10.08.2016

314

Case No.:65/1/82-ALC1/2016 Party Name:BDR

PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01839/AM16/
RLA File :03/94/040/00857/AM16/
Lic.No/Date:0310801883 19.01.2016 Defer Date:10.08.2016

315

Case No.:70/7/82-

ALC4/2016
Party Name:EYTAN LABS LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File RLA File Lic.No/Date:0910063146 Defer Date:

:01/82/050/00244/AM17/
:09/24/040/00543/AM16/
19.01.2016

316

Case No.:59/1/82-ALC1/2016 Party Name:GLOBE

TROTTERS PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01833/AM16/
RLA File :03/94/040/00589/AM16/
Lic.No/Date:0310801896 19.01.2016 Defer Date:10.08.2016 Decision : Information has been called for from the firm in NC meeting No.05 dated 08.06.2016 is awaited. The Committee accordingly deferred the case.

317

Case No.:114/20/82-

ALC4/2015
Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01697/AM16/
RLA File :34/24/040/00263/AM16/
Lic.No/Date:3410041814 19.01.2016 Defer Date:10.08.2016

318

Case No.:77/1/82-ALC1/2016 Party Name:MEDISPRAY

LABORATORIES PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01851/AM16/
RLA File :03/95/040/00657/AM16/
Lic.No/Date:0310801888 19.01.2016 Defer Date:10.08.2016

319

Case No.:36/1/82-ALC1/2016 Party Name:SI GROUP INDIA

LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/01810/AM16/
RLA File :03/95/040/00779/AM16/
Lic.No/Date:0310801890 19.01.2016 Defer Date:
Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting no.06/82 dated 29.08.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

320

Case No.:76/1/82-ALC1/2016 Party Name:TITAN

LABORATORIES PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01850/AM16/
RLA File :03/95/040/00790/AM16/
Lic.No/Date:0310801892 19.01.2016 Defer Date:10.08.2016

321

Case No.:50/1/82-ALC1/2016 Party Name:AMINES &

PLASTICIZERS LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01824/AM16/
RLA File :03/94/040/00861/AM16/
Lic.No/Date:0310801928 20.01.2016 Defer Date:10.08.2016

Decision :Deferred.

322

Case No.:68/1/82-ALC1/2016 Party Name:BTL EXPORTS

PVT. LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01842/AM16/
RLA File :03/94/040/00834/AM16/
Lic.No/Date:0310801927 20.01.2016 Defer Date:10.08.2016 Decision :Deferred.

323

Case No.:106/20/82-

ALC4/2015
Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01689/AM16/
RLA File :05/24/040/00515/AM16/
Lic.No/Date:0510397367 20.01.2016 Defer Date:10.08.2016

324

Case No.:38/1/82-ALC1/2016 Party Name:SURVIVAL

TECHNOLOGIES PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01812/AM16/
RLA File :03/95/040/00798/AM16/
Lic.No/Date:0310801923 20.01.2016 Defer Date:10.08.2016 Decision :Deferred.

325

Case No.:115/20/82-

ALC4/2015
Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/01698/AM16/
RLA File :34/24/040/00268/AM16/
Lic.No/Date:3410041823 21.01.2016 Defer Date:
Pharmaceuticals forwarded vide O.M. No. 35011/768/2015-PI(Norms) dated June 2016,

326

Case No.:49/1/82-ALC1/2016 Party Name:AMINES &

PLASTICIZERS LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01823/AM16/
RLA File :03/94/040/00869/AM16/
Lic.No/Date:0310801950 21.01.2016 Defer Date:10.08.2016 Decision :Deferred

327

Case No.:47/1/82-ALC1/2016 Party Name:BDR

PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01821/AM16/
RLA File :03/94/040/00864/AM16/
Lic.No/Date:0310801994 22.01.2016 Defer Date:10.08.2016

328

Case No.:67/1/82-ALC1/2016 Party Name:INDOCO

REMEDIES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01841/AM16/
RLA File :03/94/040/00880/AM16/
Lic.No/Date:0310802014 22.01.2016 Defer Date:10.08.2016

329

Case No.:24/1/82-ALC1/2016 Party Name:MALLADI

DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deffered HQ File :01/82/050/01798/AM16/
RLA File :04/24/040/00210/AM16/
Lic.No/Date:0410161548 22.01.2016 Defer Date:10.08.2016 Pharmaceuticals vide O.M.No.35011/66/2016-PI(Norms) dated June 2016, uploaded at the end of these minutes decided to call for technical information from the firm and deferred the case.

330

Case No.:83/7/82-ALC4/2016 Party Name:METROCHEM

API PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Case Approved HQ File :01/82/050/00257/AM17/
RLA File :09/24/040/00610/AM16/
Lic.No/Date:0910063152 22.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No. 35011/557/2015-PI(Norms) dated 18.07.2016,

331

Case No.:81/7/82-

ALC4/2016
Party Name:NEULAND LABORATORIES LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00255/AM17/
RLA File :09/24/040/00621/AM16/
Lic.No/Date:0910063150 22.01.2016 Defer Date:10.08.2016 Decision :Deferred.

332

Case No.:72/7/82-

ALC4/2016
Party Name:OGENE SYSTEMS INDIA LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00246/AM17/
RLA File :09/24/040/00620/AM16/
Lic.No/Date:0910063151 22.01.2016 Defer Date:10.08.2016 Decision :Deferred.

333

Case No.:71/7/82-

ALC4/2016
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00245/AM17/
RLA File :09/24/040/00626/AM16/
Lic.No/Date:0910063149 22.01.2016 Defer Date:10.08.2016

334

Case No.:97/20/82-

ALC4/2015
Party Name:SHREE BANKEY BEHARI LAL AROMATICS Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01680/AM16/
RLA File :05/24/040/00522/AM16/
Lic.No/Date:0510397405 22.01.2016 Defer Date:10.08.2016 Decision :Deferred.

335

Case No.:96/20/82-

ALC4/2015
Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01679/AM16/
RLA File :02/24/040/00178/AM16/
Lic.No/Date:0210206458 22.01.2016 Defer Date:10.08.2016

336

Case No.:51/1/82-ALC1/2016 Party Name:BDR

PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01825/AM16/
RLA File :03/94/040/00877/AM16/
Lic.No/Date:0310802029 25.01.2016 Defer Date:10.08.2016 Decision :Deferred for want of comments from DOP.

337

Case No.:52/1/82-ALC1/2016 Party Name:INDO AMINES

LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01826/AM16/
RLA File :03/94/040/00888/AM16/
Lic.No/Date:0310802024 25.01.2016 Defer Date:10.08.2016 Decision :Deferred.

338

Case No.:53/1/82-ALC1/2016 Party Name:DR. ACHARYA

LABORATORIES PVT. LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/01827/AM16/
RLA File :03/94/040/00881/AM16/
Lic.No/Date:0310802057 27.01.2016 Defer Date:
taken by NC in its meeting No.17/82 dated 05.12.2013 uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take

339

Case No.:89/7/82-

ALC4/2016
Party Name:GLAND PHARMA LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00263/AM17/
RLA File :09/24/040/00623/AM16/
Lic.No/Date:0910063196 29.01.2016 Defer Date:10.08.2016

340

Case No.:88/7/82-

ALC4/2016
& CHEMICALS PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00262/AM17/
RLA File :09/24/040/00304/AM16/
Lic.No/Date:0910063190 29.01.2016 Defer Date: Decision :Deferred.

341

Case No.:86/7/82-

ALC4/2016
Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00260/AM17/
RLA File :09/24/040/00633/AM16/
Lic.No/Date:0910063191 29.01.2016 Defer Date:

342

Case No.:27/1/82-ALC1/2016 Party Name:BODAL

CHEMICALS LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01801/AM16/
RLA File :08/24/040/00325/AM16/
Lic.No/Date:0810137105 01.02.2016 Defer Date:10.08.2016 Decision :Deferred.

343

Case No.:44/1/82-ALC1/2016 Party Name:ELPPE

CHEMICALS PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01818/AM16/
RLA File :03/94/040/00886/AM16/
Lic.No/Date:0310802172 02.02.2016 Defer Date:10.08.2016

344

Case No.:40/1/82-ALC1/2016 Party Name:MAGNOLIA

LIMITED. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01814/AM16/
RLA File :03/95/040/01074/AM15/
Lic.No/Date:0310802175 02.02.2016 Defer Date:10.08.2016

345

Case No.:3/5/82-ALC4/2016 Party Name:PCL OIL &

SOLVENTS LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00162/AM17/
RLA File :05/24/040/00537/AM16/
Lic.No/Date:0510397479 03.02.2016 Defer Date:10.08.2016 Decision :Deferred.

346

Case No.:37/1/82-ALC1/2016 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01811/AM16/
RLA File :03/95/040/00639/AM16/
Lic.No/Date:0310802231 04.02.2016 Defer Date:10.08.2016 Decision :Deferred.

347

Case No.:43/1/82-ALC1/2016 Party Name:AARTI

INDUSTRIES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01817/AM16/
RLA File :03/94/040/00882/AM16/
Lic.No/Date:0310802261 05.02.2016 Defer Date:10.08.2016

348

Case No.:58/1/82-ALC1/2016 Party Name:SURVIVAL

TECHNOLOGIES PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01832/AM16/
RLA File :03/95/040/00819/AM16/
Lic.No/Date:0310802266 05.02.2016 Defer Date:10.08.2016 Decision :Deferred.

349

Case No.:42/1/82-ALC1/2016 Party Name:CELOGEN

PHARMA PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Approved HQ File :01/82/050/01816/AM16/
RLA File :03/94/040/00929/AM16/
Lic.No/Date:0310802331 08.02.2016 Defer Date:
Pharmaceuticals forwarded vide O.M. No. 35011/859/2015-PI(Norms) dated 20.06.2016,

350

Case No.:69/1/82-ALC1/2016 Party Name:ENCUBE

ETHICALS PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01843/AM16/
RLA File :03/94/040/00922/AM16/
Lic.No/Date:0310802291 08.02.2016 Defer Date:10.08.2016

351

Case No.:74/1/82-ALC1/2016 Party Name:HUBERGROUP

INDIA PRIVATE LIMITED. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01848/AM16/
RLA File :03/94/040/00810/AM16/
Lic.No/Date:0310802333 08.02.2016 Defer Date:10.08.2016 Decision :Deferred.

352

Case No.:39/1/82-ALC1/2016 Party Name:PERFECT

VITAMINS PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01813/AM16/
RLA File :03/95/040/00847/AM16/
Lic.No/Date:0310802292 08.02.2016 Defer Date:10.08.2016 Decision :Deferred.

353 Case No.:60/7/82- ALC4/2016
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:7/82- ALC4/2016 Status:Deferred

07.07.2016 HQ File :01/82/050/00234/AM17/
RLA File :09/24/040/00643/AM16/
Lic.No/Date:0910063227 08.02.2016 Defer Date:

354

Case No.:75/1/82-ALC1/2016 Party Name:BLISS GVS

PHARMA LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01849/AM16/
RLA File :03/94/040/00948/AM16/
Lic.No/Date:0310802382 09.02.2016 Defer Date:10.08.2016 Decision :Deferred for want of comments from DOP.

355

Case No.:71/1/82-ALC1/2016 Party Name:HALCYON LABS

PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/01845/AM16/
RLA File :03/94/040/00916/AM16/
Lic.No/Date:0310802390 09.02.2016 Defer Date:
Pharmaceuticals forwarded vide O.M. No. 35011/67/2015-PI(Norms) dated June 2016, uploaded

356

Case No.:72/1/82-ALC1/2016 Party Name:HALCYON LABS

PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Approved HQ File :01/82/050/01846/AM16/
RLA File :03/94/040/00915/AM16/
Lic.No/Date:0310802387 09.02.2016 Defer Date:
Decision : : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No. 35011/67/2015-PI(Norms) dated June 2016, uploaded

357

Case No.:45/1/82-ALC1/2016 Party Name:KAIRAV

CHEMOFARBE INDUSTRIES LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01819/AM16/
RLA File :03/94/040/00859/AM16/
Lic.No/Date:0310802380 09.02.2016 Defer Date:10.08.2016 Decision :Deferred.

358

Case No.:114/7/82-

ALC4/2016
Party Name:VENUS REMEDIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00288/AM17/
RLA File :22/24/040/00101/AM16/
Lic.No/Date:2210015410 09.02.2016 Defer Date: Decision :Deferred

359 Case No.:70/1/82-ALC1/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:7/82- ALC4/2016 Deferred

07.07.2016 HQ File :01/82/050/01844/AM16/
RLA File :03/94/040/00935/AM16/
Lic.No/Date:0310802452 10.02.2016 Defer Date:10.08.2016

360

Case No.:79/7/82-

ALC4/2016
Party Name:OPTIMUS Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00253/AM17/
RLA File :09/24/040/00586/AM16/
Lic.No/Date:0910063240 10.02.2016 Defer Date:

361

Case No.:41/1/82-ALC1/2016 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01815/AM16/
RLA File :03/95/040/00826/AM16/
Lic.No/Date:0310802395 10.02.2016 Defer Date:10.08.2016 Decision :Deferred.

362

Case No.:78/1/82-ALC1/2016 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01852/AM16/
RLA File :03/95/040/00752/AM16/
Lic.No/Date:0310802451 10.02.2016 Defer Date:10.08.2016 Decision :Deferred.

363

Case No.:77/7/82-

ALC4/2016
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred. HQ File :01/82/050/00251/AM17/
RLA File :09/24/040/00664/AM16/
Lic.No/Date:0910063251 11.02.2016 Defer Date:10.08.2016

364

Case No.:80/7/82-

ALC4/2016
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred. HQ File :01/82/050/00254/AM17/
RLA File :09/24/040/00646/AM16/
Lic.No/Date:0910063250 11.02.2016 Defer Date:10.08.2016

365

Case No.:2/7/82-ALC4/2016 Party Name:COVALENT

LABORATORIES PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00176/AM17/
RLA File :09/24/040/00647/AM16/
Lic.No/Date:0910063256 12.02.2016 Defer Date:10.08.2016

366

Case No.:90/7/82-

ALC4/2016
Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00264/AM17/
RLA File :09/24/040/00653/AM16/
Lic.No/Date:0910063257 12.02.2016 Defer Date:10.08.2016 Decision :Deferred for want of comment from DoP.

367

Case No.:73/1/82-ALC1/2016 Party Name:HUBERGROUP

INDIA PRIVATE LIMITED. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01847/AM16/
RLA File :03/94/040/00953/AM16/
Lic.No/Date:0310802552 12.02.2016 Defer Date:10.08.2016 Decision :Deferred.

368

Case No.:117/7/82-ALC4/2016 Party Name:SAURAV

CHEMICALS LTD, Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Case Approved HQ File :01/82/050/00291/AM17/
RLA File :22/24/040/00110/AM16/
Lic.No/Date:2210015413 12.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No. 35011/134/2016-PI(Norms) dated 15.07.2016,

369

Case No.:26/1/82-ALC1/2016 Party Name:UMA

ENTERPRISE Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01800/AM16/
RLA File :08/24/040/00396/AM16/
Lic.No/Date:0810137202 15.02.2016 Defer Date:10.08.2016 Decision :Deferred.

370

Case No.:84/7/82-

ALC4/2016
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00258/AM17/
RLA File :09/24/040/00663/AM16/
Lic.No/Date:0910063276 16.02.2016 Defer Date:

371

Case No.:56/1/82-ALC1/2016 Party Name:ZIM

LABORATORIES LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01830/AM16/
RLA File :03/95/040/00887/AM16/
Lic.No/Date:0310802649 16.02.2016 Defer Date:10.08.2016

372

Case No.:17/1/82-ALC1/2016 Party Name:ARJUN

CHEMICALS PVT. LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred

HQ File :01/82/050/01791/AM16/
RLA File :04/24/040/00229/AM16/
Lic.No/Date:0410161613 17.02.2016 Defer Date:10.08.2016 Decision :Deferred.

373

Case No.:57/1/82-ALC1/2016 Party

Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01831/AM16/
RLA File :03/95/040/00895/AM16/
Lic.No/Date:0310802676 17.02.2016 Defer Date:10.08.2016 Decision :Deferred.

374

Case No.:63/7/82-

ALC4/2016
Party Name:NIFTY LABS PVT LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00237/AM17/
RLA File :09/24/040/00660/AM16/
Lic.No/Date:0910063291 17.02.2016 Defer Date:10.08.2016

375

Case No.:64/7/82-

ALC4/2016
Party Name:NIFTY LABS PVT LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00238/AM17/
RLA File :09/24/040/00658/AM16/
Lic.No/Date:0910063293 17.02.2016 Defer Date:10.08.2016

376

Case No.:65/7/82-

ALC4/2016
Party Name:NIFTY LABS PVT LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00239/AM17/
RLA File :09/24/040/00661/AM16/
Lic.No/Date:0910063292 17.02.2016 Defer Date:10.08.2016

377

Case No.:85/7/82-

ALC4/2016
Party Name:NIFTY LABS PVT LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00259/AM17/
RLA File :09/24/040/00659/AM16/
Lic.No/Date:0910063294 17.02.2016 Defer Date:10.08.2016

378

Case No.:91/7/82-ALC4/2016 Party Name:OPTIMUS

Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/00265/AM17/
RLA File :09/24/040/00670/AM16/
Lic.No/Date:0910063290 17.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No. 35011/132/2016-PI(Norms) dated 18.07 2016,

379

Case No.:73/7/82-

ALC4/2016
Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Approved HQ File :01/82/050/00247/AM17/
RLA File :09/24/040/00671/AM16/
Lic.No/Date:0910063289 17.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No. 35011/869/2015-PI(Norms) dated 24.05.2016,

380

Case No.:1/20/82-

ALC4/2015
Party Name:DIVIS LABORATORIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Approved HQ File :01/82/050/01584/AM16/
RLA File :09/24/040/00689/AM16/
Lic.No/Date:0910063311 22.02.2016 Defer Date:
Pharmaceuticals forwarded vide O.M. No. 35011/174/2015-PI(Norms) dated 19.07.2016,

381

Case No.:87/7/82-

ALC4/2016
Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00261/AM17/
RLA File :09/24/040/00696/AM16/
Lic.No/Date:0910063310 22.02.2016 Defer Date:10.08.2016

382

Case No.:56/7/82-

ALC4/2016
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00230/AM17/
RLA File :09/24/040/00677/AM16/
Lic.No/Date:0910063309 22.02.2016 Defer Date:10.08.2016

383

Case No.:68/7/82-

ALC4/2016
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00242/AM17/
RLA File :09/24/040/00683/AM16/
Lic.No/Date:0910063308 22.02.2016 Defer Date:10.08.2016

384

Case No.:78/7/82-

ALC4/2016
Party Name:VIVIMED LABS LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00252/AM17/
RLA File :09/24/040/00592/AM16/
Lic.No/Date:0910063303 22.02.2016 Defer Date:10.08.2016

Decision :Deferred.

385

Case No.:97/7/82-

ALC4/2016
Party Name:SRINI PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00271/AM17/
RLA File :09/24/040/00694/AM16/
Lic.No/Date:0910063328 26.02.2016 Defer Date:10.08.2016

386

Case No.:116/7/82-

ALC4/2016
Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00290/AM17/
RLA File :22/24/040/00111/AM16/
Lic.No/Date:2210015421 26.02.2016 Defer Date:10.08.2016 Decision :Deferred.

387

Case No.:66/7/82-ALC4/2016 Party Name:VIRUPAKSHA

ORGANICS LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/00240/AM17/
RLA File :09/24/040/00701/AM16/
Lic.No/Date:0910063329 26.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No. 35011/136/2015-PI(Norms) dated 15.07.2016,

388

Case No.:96/7/82-ALC4/2016 Party Name:VISION DRUGS

PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/00270/AM17/
RLA File :09/24/040/00675/AM16/
Lic.No/Date:0910063331 29.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No. 35011/131/2016-PI(Norms) dated 18.07.2016,

389

Case No.:12/7/82-

ALC4/2016
Party Name:MEDICLONE BIO-TECH PRIVATE LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00186/AM17/
RLA File :04/24/040/00250/AM16/
Lic.No/Date:0410161677 01.03.2016 Defer Date: Decision :Deferred for want of comments from DBT.

390

Case No.:18/1/82-ALC1/2016 Party Name:STRIDES

SHASUN LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01792/AM16/
RLA File :04/24/040/00248/AM16/
Lic.No/Date:0410161671 01.03.2016 Defer Date:10.08.2016

391

Case No.:20/1/82-ALC1/2016 Party Name:STRIDES

SHASUN LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01794/AM16/
RLA File :04/24/040/00247/AM16/
Lic.No/Date:0410161672 01.03.2016 Defer Date:10.08.2016

392

Case No.:21/1/82-ALC1/2016 Party Name:STRIDES

SHASUN LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01795/AM16/
RLA File :04/24/040/00246/AM16/
Lic.No/Date:0410161670 01.03.2016 Defer Date:10.08.2016

393

Case No.:67/7/82-

ALC4/2016
Party Name:BIOLOGICAL E LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00241/AM17/
RLA File :09/24/040/00714/AM16/
Lic.No/Date:0910063353 03.03.2016 Defer Date:

394

Case No.:25/7/82-

ALC4/2016
Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Approved HQ File :01/82/050/00199/AM17/
RLA File :31/83/040/00164/AM16/
Lic.No/Date:3110066028 03.03.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/3/2012-Ch-II Vol-I dated 16.2.2016, 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.

395

Case No.:40/7/82-

ALC4/2016
Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Approved HQ File :01/82/050/00214/AM17/
RLA File :31/83/040/00169/AM16/
Lic.No/Date:3110066029 03.03.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/3/2012-Ch-II Vol-I dated 16.2.2016, 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.

396

Case No.:82/7/82-

ALC4/2016
Party Name:OPTIMUS Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00256/AM17/
RLA File :09/24/040/00721/AM16/
Lic.No/Date:0910063357 03.03.2016 Defer Date:

Decision :Deferred for want of comments from DOP.

397

Case No.:92/7/82-

ALC4/2016
Party Name:OPTIMUS Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00266/AM17/
RLA File :09/24/040/00720/AM16/
Lic.No/Date:0910063358 03.03.2016 Defer Date:

398

Case No.:119/7/82-

ALC4/2016
Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00293/AM17/
RLA File :22/24/040/00121/AM16/
Lic.No/Date:2210015426 04.03.2016 Defer Date:

399

Case No.:26/7/82-ALC4/2016 Party Name:EMCURE

Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/00200/AM17/
RLA File :31/83/040/00171/AM16/
Lic.No/Date:3110066039 08.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No. 35011/19/2016-PI(Norms) dated June 2016, uploaded

400

Case No.:118/7/82-

ALC4/2016
Party Name:CHIROS PHARMA Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00292/AM17/
RLA File :22/24/040/00114/AM16/
Lic.No/Date:2210015440 09.03.2016 Defer Date:

401

Case No.:120/7/82-

ALC4/2016
Party Name:CHIROS PHARMA Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00294/AM17/
RLA File :22/24/040/00113/AM16/
Lic.No/Date:2210015441 09.03.2016 Defer Date:

402

Case No.:113/7/82-

ALC4/2016
Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Approved HQ File :01/82/050/00287/AM17/
RLA File :22/24/040/00123/AM16/
Lic.No/Date:2210015437 09.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No. 35011/64/2016-PI(Norms) dated June 2016, uploaded

403

Case No.:115/7/82-

ALC4/2016
Party Name:SAURAV CHEMICALS LTD, Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Approved HQ File :01/82/050/00289/AM17/
RLA File :22/24/040/00120/AM16/
Lic.No/Date:2210015439 09.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No. 35011/134/2016-PI(Norms) dated 15.07.2016,

404

Case No.:93/7/82-

ALC4/2016
Party Name:SHREE JAYA LABORATORIES PVT LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Approved HQ File :01/82/050/00267/AM17/
RLA File :09/24/040/00712/AM16/
Lic.No/Date:0910063390 10.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No. 35011/137/2016-PI(Norms) dated 15.07.2016,

405

Case No.:94/7/82-

ALC4/2016
Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Approved HQ File :01/82/050/00268/AM17/
RLA File :09/24/040/00722/AM16/
Lic.No/Date:0910063394 11.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No. 35011/132/2016-PI(Norms) dated 18.07.2016,

406

Case No.:59/7/82-

ALC4/2016
Party Name:RUCHI SOYA INDUSTRIES LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00233/AM17/
RLA File :56/24/040/00054/AM16/
Lic.No/Date:5610004864 11.03.2016 Defer Date: Decision :Deferred.

407

Case No.:28/7/82-

ALC4/2016
Party Name:BALAJI AMINES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Approved HQ File :01/82/050/00202/AM17/
RLA File :31/83/040/00177/AM16/
Lic.No/Date:3110066048 14.03.2016 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.04 dated 03.07.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as

per decision of NC.

408

Case No.:102/7/82-

ALC4/2016
Party Name:BALAJI AMINES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Approved HQ File :01/82/050/00276/AM17/
RLA File :31/83/040/00176/AM16/
Lic.No/Date:3110066047 14.03.2016 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.08 dated 25.09.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

409

Case No.:100/7/82-

ALC4/2016
Party Name:CATAPHARMA CHEMICALS PVT. LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Deferred HQ File :01/82/050/00274/AM17/
RLA File :31/83/040/00174/AM16/
Lic.No/Date:3110066051 14.03.2016 Defer Date:10.08.2016

410

Case No.:101/7/82-ALC4/2016 Party Name:CLEAN SCIENCE

AND TECHNOLOGY PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/00275/AM17/
RLA File :31/83/040/00172/AM16/
Lic.No/Date:3110066050 14.03.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/3/2012-Ch-II Vol.1 dated 16.2.2016 dated 15.07.2016, uploaded

411

Case No.:13/1/82-ALC1/2016 Party Name:ONEIRO

CHEMICALS LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01787/AM16/
RLA File :34/24/040/00286/AM16/
Lic.No/Date:3410041972 14.03.2016 Defer Date:10.08.2016 Decision :Deferred.

412

Case No.:15/1/82-ALC1/2016 Party Name:COVALENT

LABORATORIES PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01789/AM16/
RLA File :09/24/040/00713/AM16/
Lic.No/Date:0910063416 15.03.2016 Defer Date:10.08.2016

413

Case No.:14/1/82-ALC1/2016 Party Name:DIVIS

LABORATORIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01788/AM16/
RLA File :09/24/040/00716/AM16/
Lic.No/Date:0910063414 15.03.2016 Defer Date:10.08.2016

Decision :The Committee decided to send copy of application to DoP.

414

Case No.:110/7/82-

ALC4/2016
Party Name:TIDE INDUSTRIES Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00284/AM17/
RLA File :34/24/040/00338/AM16/
Lic.No/Date:3410041981 16.03.2016 Defer Date:10.08.2016 Decision :Deferred.

415

Case No.:107/7/82-

ALC4/2016
Party Name:ASTRAL STERITECH PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00281/AM17/
RLA File :34/24/040/00345/AM16/
Lic.No/Date:3410041995 21.03.2016 Defer Date:10.08.2016

416

Case No.:109/7/82-

ALC4/2016
Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00283/AM17/
RLA File :34/24/040/00336/AM16/
Lic.No/Date:3410041989 21.03.2016 Defer Date:10.08.2016 Decision :Deferred

417

Case No.:111/7/82-

ALC4/2016
Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00285/AM17/
RLA File :34/24/040/00346/AM16/
Lic.No/Date:3410041992 21.03.2016 Defer Date:10.08.2016 Decision :Deferred

418

Case No.:122/7/82-

ALC4/2016
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00296/AM17/
RLA File :03/94/040/01019/AM16/
Lic.No/Date:0310803499 22.03.2016 Defer Date:10.08.2016 Decision :Deferred.

419

Case No.:69/7/82-

ALC4/2016
Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Approved HQ File :01/82/050/00243/AM17/
RLA File :22/24/040/00131/AM16/
Lic.No/Date:2210015452 22.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/75/2016-PI(Norms) dated July 2016, uploaded

420

Case No.:48/4/82-ALC4/2016 Party Name:AVA

CHEMICALS PVT.LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00111/AM17/
RLA File :03/94/040/01067/AM16/
Lic.No/Date:0310803525 23.03.2016 Defer Date:10.08.2016 Decision :Deferred.

421

Case No.:57/7/82-

ALC4/2016
Party Name:CHIROS PHARMA Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00231/AM17/
RLA File :22/24/040/00125/AM16/
Lic.No/Date:2210015455 23.03.2016 Defer Date:10.08.2016

422

Case No.:61/7/82-

ALC4/2016
Party Name:CHIROS PHARMA Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00235/AM17/
RLA File :22/24/040/00127/AM16/
Lic.No/Date:2210015457 23.03.2016 Defer Date:10.08.2016

423

Case No.:62/7/82-

ALC4/2016
Party Name:CHIROS PHARMA Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00236/AM17/
RLA File :22/24/040/00128/AM16/
Lic.No/Date:2210015456 23.03.2016 Defer Date:10.08.2016

424

Case No.:85/1/82-ALC1/2016 Party Name:DIVIS

LABORATORIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/01859/AM16/
RLA File :09/24/040/00730/AM16/
Lic.No/Date:0910063440 23.03.2016 Defer Date:10.08.2016

425

Case No.:108/7/82-

ALC4/2016
Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Approved HQ File :01/82/050/00282/AM17/
RLA File :05/23/040/00518/AM16/
Lic.No/Date:0510398017 23.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No. 35011/68/2016-PI(Norms) dated June 2016, uploaded

426

Case No.:112/7/82-

ALC4/2016
Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Approved

HQ File :01/82/050/00286/AM17/
RLA File :05/23/040/00517/AM16/
Lic.No/Date:0510398025 23.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No. 35011/116/2016-PI(Norms) dated July 2016,

427

Case No.:3/7/82-ALC4/2016 Party Name:DHANUKA

LABORATORIES LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00177/AM17/
RLA File :05/23/040/00551/AM16/
Lic.No/Date:0510398033 28.03.2016 Defer Date: 10.08.2016

428

Case No.:5/7/82-ALC4/2016 Party Name:CADILA

Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00179/AM17/
RLA File :08/24/040/00466/AM16/
Lic.No/Date:0810137553 30.03.2016 Defer Date: 10.08.2016

429

Case No.:95/7/82-

ALC4/2016
Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00269/AM17/
RLA File :22/24/040/00132/AM16/
Lic.No/Date:2210015462 30.03.2016 Defer Date: 10.08.2016

430

Case No.:39/7/82-

ALC4/2016
Party Name:POSY PHARMACHEM PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00213/AM17/
RLA File :08/24/040/00426/AM16/
Lic.No/Date:0810137551 30.03.2016 Defer Date:10.08.2016

431

Case No.:16/7/82-ALC4/2016 Party Name:U SQUARE

LIFESCIENCE PRIVATE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/00190/AM17/
RLA File :08/24/040/00453/AM16/
Lic.No/Date:0810137554 30.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/816/2015-PI(Norms) dated June 2016, uploaded

432

Case No.:58/7/82-

ALC4/2016
Party Name:VENUS REMEDIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred

HQ File :01/82/050/00232/AM17/
RLA File :22/24/040/00133/AM16/
Lic.No/Date:2210015463 31.03.2016 Defer Date: Decision : Deferred for want of comments from DoP.

433

Case No.:138/7/82-

ALC4/2016
Party Name:ALTA LABORATORIES LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00312/AM17/
RLA File :03/94/040/01112/AM16/
Lic.No/Date:0310803707 01.04.2016 Defer Date: 10.08.2016

434

Case No.:103/7/82-

ALC4/2016
Party Name:JUBILANT GENERICS LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00277/AM17/
RLA File :05/23/040/00555/AM16/
Lic.No/Date:0510398126 01.04.2016 Defer Date: 10.08.2016 Decision :Deferred.

435

Case No.:104/7/82-

ALC4/2016
Party Name:JUBILANT GENERICS LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00278/AM17/
RLA File :05/23/040/00556/AM16/
Lic.No/Date:0510398125 01.04.2016 Defer Date: 10.08.2016 Decision :Deferred.

436

Case No.:121/7/82-

ALC4/2016
Party Name:VARUN MEDIMPEX INC. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00295/AM17/
RLA File :05/24/040/00632/AM16/
Lic.No/Date:0510398119 01.04.2016 Defer Date: 10.08.2016 Decision : Deferred for want of comments form DoP.

437

Case No.:4/7/82-ALC4/2016 Party Name:CADILA

Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00178/AM17/
RLA File :08/24/040/00001/AM17/
Lic.No/Date:0810137612 05.04.2016 Defer Date: 10.08.2016 Decision : Deferred for want of comments form DoP.

438

Case No.:6/7/82-ALC4/2016 Party Name:CADILA

Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00180/AM17/
RLA File :08/24/040/00470/AM16/
Lic.No/Date:0810137611 05.04.2016 Defer Date: 10.08.2016 Decision : Deferred for want of comments form DoP.

439 Case No.:24/7/82- Party Name:DEEPAK Meet No/Date:7/82- Status:Deferred

ALC4/2016
NOVOCHEM TECHNOLOGIES LTD ALC4/2016 07.07.2016 HQ File :01/82/050/00198/AM17/
RLA File :31/83/040/00186/AM16/
Lic.No/Date:3110066111 05.04.2016 Defer Date: 10.08.2016 Decision :Deferred.

440

Case No.:38/7/82-

ALC4/2016
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00212/AM17/
RLA File :05/23/040/00571/AM16/
Lic.No/Date:0510398134 05.04.2016 Defer Date: 10.08.2016

441

Case No.:105/7/82-

ALC4/2016
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00279/AM17/
RLA File :05/23/040/00573/AM16/
Lic.No/Date:0510398133 05.04.2016 Defer Date: 10.08.2016

442

Case No.:106/7/82-

ALC4/2016
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00280/AM17/
RLA File :05/23/040/00570/AM16/
Lic.No/Date:0510398132 05.04.2016 Defer Date: 10.08.2016 Decision Deferred for want of comments from DoP.

443

Case No.:123/7/82-

ALC4/2016
Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00297/AM17/
RLA File :03/94/040/01038/AM16/
Lic.No/Date:0310803819 06.04.2016 Defer Date: 10.08.2016

444

Case No.:42/7/82-

ALC4/2016
Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00216/AM17/
RLA File :34/24/040/00325/AM16/
Lic.No/Date:3410042036 07.04.2016 Defer Date: 10.08.2016

445

Case No.:43/7/82-

ALC4/2016
Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00217/AM17/
RLA File :34/24/040/00355/AM16/
Lic.No/Date:3410042037 07.04.2016 Defer Date: 10.08.2016

446

Case No.:27/7/82-ALC4/2016 Party Name:DSM SINOCHEM

PHARMACEUTICALS INDIA PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/00201/AM17/
RLA File :22/24/040/00002/AM17/
Lic.No/Date:2210015464 08.04.2016 Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/75/2016-PI(Norms) dated July 2016, uploaded

447

Case No.:23/7/82-ALC4/2016 Party Name:SENTISS

PHARMA PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/00197/AM17/
RLA File :05/24/040/00006/AM17/
Lic.No/Date:0510398158 08.04.2016 Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/778/2015-PI(Norms) dated June 2016,

448

Case No.:150/7/82-

ALC4/2016
Party Name:CLARIANT INDIA LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00324/AM17/
RLA File :03/94/040/00003/AM17/
Lic.No/Date:0310803875 11.04.2016 Defer Date: 10.08.2016 Decision :Deferred.

449

Case No.:151/7/82-

ALC4/2016
Party Name:CLARIANT INDIA LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00325/AM17/
RLA File :03/94/040/00002/AM17/
Lic.No/Date:0310803873 11.04.2016 Defer Date: 10.08.2016 Decision :Deferred.

450

Case No.:52/7/82-

ALC4/2016
Party Name:FINE CURE Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00226/AM17/
RLA File :08/24/040/00460/AM16/
Lic.No/Date:0810137652 11.04.2016 Defer Date: 10.08.2016

451

Case No.:45/7/82-

ALC4/2016
Party Name:ASTRAL STERITECH PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00219/AM17/
RLA File :34/24/040/00009/AM17/
Lic.No/Date:3410042064 13.04.2016 Defer Date: 10.08.2016

452

Case No.:44/7/82-

ALC4/2016
Party Name:AMI LIFESCIENCES P LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00218/AM17/
RLA File :34/24/040/00356/AM16/
Lic.No/Date:3410042066 15.04.2016 Defer Date: 10.08.2016 Pharmaceuticals forwarded vide O.M. No.35011/825/2015-PI(Norms) dated 01.06.2016,

453

Case No.:50/7/82-

ALC4/2016
Party Name:BODAL CHEMICALS LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00224/AM17/
RLA File :08/24/040/00005/AM17/
Lic.No/Date:0810137692 18.04.2016 Defer Date: 10.08.2016 Decision :Deferred

454

Case No.:10/7/82-

ALC4/2016
Party Name:STRIDES SHASUN LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00184/AM17/
RLA File :04/24/040/00002/AM17/
Lic.No/Date:0410161814 18.04.2016 Defer Date: 10.08.2016

455

Case No.:11/7/82-

ALC4/2016
Party Name:STRIDES SHASUN LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00185/AM17/
RLA File :04/24/040/00003/AM17/
Lic.No/Date:0410161815 18.04.2016 Defer Date: 10.08.2016

456

Case No.:13/7/82-

ALC4/2016
Party Name:STRIDES SHASUN LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00187/AM17/
RLA File :04/24/040/00004/AM17/
Lic.No/Date:0410161816 18.04.2016 Defer Date: 10.08.2016

457

Case No.:98/7/82-

ALC4/2016
Party Name:CADILA HEALTHCARE LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00272/AM17/
RLA File :08/24/040/00015/AM17/
Lic.No/Date:0810137712 21.04.2016 Defer Date: 10.08.2016

458 Case No.:34/7/82-ALC4/2016 Party Name:SUN PHARMACEUTICAL Meet No/Date:7/82- ALC4/2016 Status: Approved

INDUSTRIES LTD., 07.07.2016 HQ File :01/82/050/00208/AM17/
RLA File :05/24/040/00015/AM17/
Lic.No/Date:0510398256 21.04.2016 Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/18/2016-PI(Norms) dated June 2016, uploaded

459

Case No.:35/7/82-

ALC4/2016
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00209/AM17/
RLA File :05/24/040/00016/AM17/
Lic.No/Date:0510398257 21.04.2016 Defer Date: 10.08.2016

460

Case No.:33/7/82-

ALC4/2016
Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00207/AM17/
RLA File :05/23/040/00018/AM17/
Lic.No/Date:0510398279 22.04.2016 Defer Date: 10.08.2016

461

Case No.:29/7/82-

ALC4/2016
Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00203/AM17/
RLA File :05/24/040/00028/AM17/
Lic.No/Date:0510398295 25.04.2016 Defer Date: 10.08.2016

462

Case No.:31/7/82-

ALC4/2016
Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00205/AM17/
RLA File :05/24/040/00030/AM17/
Lic.No/Date:0510398296 25.04.2016 Defer Date: 10.08.2016

463

Case No.:22/7/82-

ALC4/2016
Party Name:S.M. HERBALS PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Approved HQ File :01/82/050/00196/AM17/
RLA File :05/24/040/00012/AM17/
Lic.No/Date:0510398297 25.04.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No. 35011/133/2015-PI(Norms) dated 18.07.2016,

464 Case No.:15/7/82- ALC4/2016
Party Name:SUPREET CHEMICALS PVT.LTD. Meet No/Date:7/82- ALC4/2016 Status:Deferred

07.07.2016 HQ File :01/82/050/00189/AM17/
RLA File :52/24/040/00006/AM17/
Lic.No/Date:5210041869 25.04.2016 Defer Date: 10.08.2016 Decision :Deferred.

465

Case No.:99/7/82-

ALC4/2016
Party Name:SUPREET CHEMICALS PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00273/AM17/
RLA File :52/24/040/00007/AM17/
Lic.No/Date:5210041868 25.04.2016 Defer Date: 10.08.2016 Decision :Deferred.

466

Case No.:125/7/82-

ALC4/2016
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00299/AM17/
RLA File :03/95/040/00061/AM17/
Lic.No/Date:0310804144 25.04.2016 Defer Date: 10.08.2016 Decision :Deferred.

467

Case No.:126/7/82-

ALC4/2016
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00300/AM17/
RLA File :03/95/040/00064/AM17/
Lic.No/Date:0310804154 25.04.2016 Defer Date: 10.08.2016 Decision :Deferred.

468

Case No.:145/7/82-

ALC4/2016
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00319/AM17/
RLA File :03/94/040/00072/AM17/
Lic.No/Date:0310804202 26.04.2016 Defer Date: 10.08.2016

469

Case No.:144/7/82-

ALC4/2016
Party Name:GOLD STAR CHEMICALS PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00318/AM17/
RLA File :03/94/040/01042/AM16/
Lic.No/Date:0310804172 26.04.2016 Defer Date: 10.08.2016 Decision :Deferred.

470

Case No.:148/7/82-

ALC4/2016
Party Name:HEMA DYE CHEM PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00322/AM17/
RLA File :03/94/040/00055/AM17/
Lic.No/Date:0310804211 26.04.2016 Defer Date: 10.08.2016 Decision :Deferred.

471

Case No.:149/7/82-

ALC4/2016
Party Name:IPCA LABORATORIES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00323/AM17/
RLA File :03/94/040/00070/AM17/
Lic.No/Date:0310804209 26.04.2016 Defer Date: taken by NC in its meeting No.03/82 dated 20.05.2015 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

472

Case No.:127/7/82-

ALC4/2016
Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00301/AM17/
RLA File :03/95/040/00048/AM17/
Lic.No/Date:0310804183 26.04.2016 Defer Date: 10.08.2016 Decision :Deferred.

473

Case No.:128/7/82-

ALC4/2016
Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00302/AM17/
RLA File :03/95/040/00049/AM17/
Lic.No/Date:0310804184 26.04.2016 Defer Date: 10.08.2016 Decision :Deferred.

474

Case No.:32/7/82-

ALC4/2016
Party Name:HELLO PAINTS (P) LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00206/AM17/
RLA File :05/23/040/00036/AM17/
Lic.No/Date:0510398321 27.04.2016 Defer Date: 10.08.2016 Decision :Deferred.

475

Case No.:130/7/82-

ALC4/2016
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00304/AM17/
RLA File :03/95/040/00068/AM17/
Lic.No/Date:0310804238 27.04.2016 Defer Date: 10.08.2016 Decision :Deferred.

476

Case No.:146/7/82-

ALC4/2016
Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00320/AM17/
RLA File :03/94/040/00012/AM17/
Lic.No/Date:0310804283 29.04.2016 Defer Date: 10.08.2016

477 Case No.:147/7/82- ALC4/2016
Party Name:BENZO CHEM INDUSTRIES PRIVATE Meet No/Date:7/82- ALC4/2016 Status:Deferred

LIMITED, 07.07.2016 HQ File :01/82/050/00321/AM17/
RLA File :03/94/040/00063/AM17/
Lic.No/Date:0310804284 29.04.2016 Defer Date: 10.08.2016 Decision :Deferred.

478

Case No.:143/7/82-

ALC4/2016
Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00317/AM17/
RLA File :03/94/040/00064/AM17/
Lic.No/Date:0310804295 29.04.2016 Defer Date: 10.08.2016

479

Case No.:36/7/82-

ALC4/2016
Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00210/AM17/
RLA File :22/24/040/00004/AM17/
Lic.No/Date:2210015474 29.04.2016 Defer Date: 10.08.2016

480

Case No.:37/7/82-

ALC4/2016
Party Name:SAURAV CHEMICALS LTD, Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Approved HQ File :01/82/050/00211/AM17/
RLA File :22/24/040/00006/AM17/
Lic.No/Date:2210015472 29.04.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No. 35011/134/2016-PI(Norms) dated 15.07.2016,

481

Case No.:142/7/82-

ALC4/2016
Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00316/AM17/
RLA File :03/94/040/01101/AM16/
Lic.No/Date:0310804342 02.05.2016 Defer Date: 10.08.2016

482

Case No.:129/7/82-

ALC4/2016
Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00303/AM17/
RLA File :03/95/040/00004/AM17/
Lic.No/Date:0310804339 02.05.2016 Defer Date: 10.08.2016 Decision :Deferred.

483

Case No.:14/7/82-

ALC4/2016
Party Name:CADILA HEALTHCARE LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00188/AM17/
RLA File :08/24/040/00035/AM17/
Lic.No/Date:0810137832 03.05.2016 Defer Date: 10.08.2016

484

Case No.:75/7/82-

ALC4/2016
Party Name:ALKALOIDS CORPORATION Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00249/AM17/
RLA File :02/24/040/00016/AM17/
Lic.No/Date:0210206661 04.05.2016 Defer Date: 10.08.2016

485

Case No.:21/7/82-

ALC4/2016
Party Name:CADILA HEALTHCARE LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00195/AM17/
RLA File :08/24/040/00049/AM17/
Lic.No/Date:0810137835 04.05.2016 Defer Date: 10.08.2016

486

Case No.:46/7/82-

ALC4/2016
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00220/AM17/
RLA File :05/24/040/00041/AM17/
Lic.No/Date:0510398375 04.05.2016 Defer Date: 10.08.2016

487

Case No.:48/7/82-

ALC4/2016
Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Approved HQ File :01/82/050/00222/AM17/
RLA File :05/24/040/00049/AM17/
Lic.No/Date:0510398391 05.05.2016 Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/120/2016-PI(Norms) dated July 2016, uploaded

488

Case No.:49/7/82-

ALC4/2016
Party Name:PANACEA BIOTEC LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00223/AM17/
RLA File :05/24/040/00009/AM17/
Lic.No/Date:0510398392 05.05.2016 Defer Date: 10.08.2016

489

Case No.:8/7/82-ALC4/2016 Party Name:STRIDES

SHASUN LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00182/AM17/
RLA File :04/24/040/00009/AM17/
Lic.No/Date:0410161871 05.05.2016 Defer Date: 10.08.2016

490

Case No.:9/7/82-ALC4/2016 Party Name:STRIDES

SHASUN LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00183/AM17/
RLA File :04/24/040/00010/AM17/
Lic.No/Date:0410161872 05.05.2016 Defer Date: 10.08.2016

491

Case No.:163/7/82-

ALC4/2016
Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00337/AM17/
RLA File :03/94/040/00090/AM17/
Lic.No/Date:0310804480 09.05.2016 Defer Date:10.08.2016

492

Case No.:141/7/82-

ALC4/2016
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00315/AM17/
RLA File :03/94/040/00041/AM17/
Lic.No/Date:0310804465 09.05.2016 Defer Date: 10.08.2016 Decision :Deferred.

493

Case No.:17/7/82-

ALC4/2016
Party Name:CONTINENTAL CHEMICALS Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00191/AM17/
RLA File :08/24/040/00045/AM17/
Lic.No/Date:0810137878 09.05.2016 Defer Date: 10.08.2016 Decision :Deferred

494

Case No.:18/7/82-

ALC4/2016
Party Name:CONTINENTAL CHEMICALS Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00192/AM17/
RLA File :08/24/040/00044/AM17/
Lic.No/Date:0810137877 09.05.2016 Defer Date: 10.08.2016 Decision :Deferred.

495

Case No.:161/7/82-

ALC4/2016
Party Name:GITANJALI CHEMICALS PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00335/AM17/
RLA File :03/94/040/00026/AM17/
Lic.No/Date:0310804504 09.05.2016 Defer Date: 10.08.2016 Decision :Deferred.

496

Case No.:51/7/82-

ALC4/2016
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00225/AM17/
RLA File :05/23/040/00539/AM16/
Lic.No/Date:0510398432 09.05.2016 Defer Date: 10.08.2016 Decision :Deferred.

497

Case No.:159/7/82-

ALC4/2016
Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00333/AM17/
RLA File :03/94/040/00061/AM17/
Lic.No/Date:0310804534 10.05.2016 Defer Date: 10.08.2016 Decision :Deferred.

498

Case No.:160/7/82-

ALC4/2016
Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00334/AM17/
RLA File :03/94/040/00036/AM17/
Lic.No/Date:0310804533 10.05.2016 Defer Date: 10.08.2016 Decision :Deferred.

499

Case No.:76/7/82-

ALC4/2016
Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00250/AM17/
RLA File :05/23/040/00031/AM17/
Lic.No/Date:0510398443 10.05.2016 Defer Date: 10.08.2016

500

Case No.:162/7/82-

ALC4/2016
Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Approved HQ File :01/82/050/00336/AM17/
RLA File :03/94/040/00107/AM17/
Lic.No/Date:0310804532 10.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No. 35011/179/2016-PI(Norms) dated 19.07.2016,

501

Case No.:47/7/82-

ALC4/2016
Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00221/AM17/
RLA File :05/24/040/00053/AM17/
Lic.No/Date:0510398448 10.05.2016 Defer Date: 10.08.2016

502

Case No.:137/7/82-

ALC4/2016
Party Name:RELIANCE INDUSTRIES LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00311/AM17/
RLA File :03/95/040/00763/AM16/
Lic.No/Date:0310804513 10.05.2016 Defer Date: 10.08.2016 Decision :Deferred.

503 Case No.:157/7/82- ALC4/2016
Party Name:APEX PHARMA, Meet No/Date:7/82- ALC4/2016 Status:Deferred

07.07.2016 HQ File :01/82/050/00331/AM17/
RLA File :03/94/040/00122/AM17/
Lic.No/Date:0310804628 12.05.2016 Defer Date: 10.08.2016

504

Case No.:74/7/82-

ALC4/2016
Party Name:KLJ PLASTICIZERS LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00248/AM17/
RLA File :05/23/040/00050/AM17/
Lic.No/Date:0510398481 12.05.2016 Defer Date: 10.08.2016 Decision :Deferred.

505

Case No.:158/7/82-

ALC4/2016
Party Name:KUBO COMBUSTION EFFICIENCY CHEMICALS PVT LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00332/AM17/
RLA File :03/94/040/01064/AM16/
Lic.No/Date:0310804642 12.05.2016 Defer Date: 10.08.2016 Decision :Deferred.

506

Case No.:19/7/82-

ALC4/2016
Party Name:CADILA HEALTHCARE LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Approved HQ File :01/82/050/00193/AM17/
RLA File :08/24/040/00062/AM17/
Lic.No/Date:0810137906 13.05.2016 Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/435/2013-PI(Norms) dated 11.09.2013,

507

Case No.:20/7/82-

ALC4/2016
Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00194/AM17/
RLA File :22/24/040/00011/AM17/
Lic.No/Date:2210015481 13.05.2016 Defer Date: 10.08.2016 Decision :Deferred.

508

Case No.:131/7/82-

ALC4/2016
Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00305/AM17/
RLA File :03/95/040/00016/AM17/
Lic.No/Date:0310804666 13.05.2016 Defer Date: 10.08.2016 Decision :Deferred.

509

Case No.:135/7/82-

ALC4/2016
Party Name:UNIMAX CHEMICALS PVT LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File RLA File Lic.No/Date:0310804670 Defer Date:

:01/82/050/00309/AM17/
:03/95/040/00093/AM17/
13.05.2016 10.08.2016 Decision :Deferred.

510

Case No.:136/7/82-

ALC4/2016
Party Name:ROYAL PHARMA Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00310/AM17/
RLA File :03/95/040/00098/AM17/
Lic.No/Date:0310804724 17.05.2016 Defer Date: 10.08.2016

511

Case No.:54/7/82-

ALC4/2016
Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00228/AM17/
RLA File :05/23/040/00064/AM17/
Lic.No/Date:0510398544 18.05.2016 Defer Date: 10.08.2016

512

Case No.:55/7/82-

ALC4/2016
Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00229/AM17/
RLA File :05/23/040/00063/AM17/
Lic.No/Date:0510398543 18.05.2016 Defer Date: 10.08.2016

513

Case No.:53/7/82-

ALC4/2016
Party Name:CADILA Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00227/AM17/
RLA File :08/24/040/00069/AM17/
Lic.No/Date:0810137950 19.05.2016 Defer Date: 10.08.2016

514

Case No.:2/5/82-ALC4/2016 Party Name:ACEBRIGHT

(INDIA) PHARMA PVT LTD, Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00161/AM17/
RLA File :07/24/040/00036/AM17/
Lic.No/Date:0710109851 20.05.2016 Defer Date:10.08.2016

515

Case No.:155/7/82-ALC4/2016 Party Name:IPCA

LABORATORIES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status: Approved HQ File :01/82/050/00329/AM17/
RLA File :03/94/040/00158/AM17/
Lic.No/Date:0310804889 20.05.2016 Defer Date: taken by NC in its meeting No.03/82 dated 08.05.2014 uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take

516

Case No.:1/5/82-ALC4/2016 Party Name:RA CHEM

PHARMA LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Deferred HQ File :01/82/050/00160/AM17/
RLA File :09/24/040/00083/AM17/
Lic.No/Date:0910063660 20.05.2016 Defer Date:10.08.2016

517

Case No.:132/7/82-

ALC4/2016
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00306/AM17/
RLA File :03/95/040/00118/AM17/
Lic.No/Date:0310804885 20.05.2016 Defer Date: 10.08.2016 Decision :Deferred.

518

Case No.:156/7/82-

ALC4/2016
Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00330/AM17/
RLA File :03/94/040/00147/AM17/
Lic.No/Date:0310804903 23.05.2016 Defer Date: 10.08.2016 Decision :Deferred.

519

Case No.:139/7/82-

ALC4/2016
Party Name:GANGWAL CHEMICALS (P) LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00313/AM17/
RLA File :03/94/040/00149/AM17/
Lic.No/Date:0310804914 23.05.2016 Defer Date: 10.08.2016 Decision :Deferred.

520

Case No.:140/7/82-

ALC4/2016
Party Name:GANGWAL CHEMICALS (P) LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00314/AM17/
RLA File :03/94/040/00148/AM17/
Lic.No/Date:0310804913 23.05.2016 Defer Date: 10.08.2016 Decision :Deferred.

521

Case No.:153/7/82-

ALC4/2016
Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00327/AM17/
RLA File :03/94/040/00115/AM17/
Lic.No/Date:0310804948 24.05.2016 Defer Date: 10.08.2016 Decision :Deferred.

522

Case No.:152/7/82-

ALC4/2016
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00326/AM17/
RLA File :03/94/040/00152/AM17/
Lic.No/Date:0310804950 24.05.2016 Defer Date: 10.08.2016

Decision :Deferred.

523

Case No.:134/7/82-

ALC4/2016
Party Name:ORBIT LIFE SCIENCE PVT. LTD. Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00308/AM17/
RLA File :03/95/040/00069/AM17/
Lic.No/Date:0310804944 24.05.2016 Defer Date: 10.08.2016

524

Case No.:154/7/82-

ALC4/2016
Party Name:IPCA LABORATORIES LIMITED Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Approved HQ File :01/82/050/00328/AM17/
RLA File :03/94/040/00159/AM17/
Lic.No/Date:0310804960 25.05.2016 Defer Date: taken by NC in its meeting No.28/82 dated 10.01.2013 uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take

525

Case No.:1/7/82-ALC4/2016 Party Name:NEULAND

LABORATORIES LTD Meet No/Date:7/82- ALC4/2016 07.07.2016 Status:Deferred HQ File :01/82/050/00175/AM17/
RLA File :09/24/040/00139/AM17/
Lic.No/Date:0910063809 21.06.2016 Defer Date: 10.08.2016

/ ヘ ro benzothiazole 2 This issues uiith the approval of competent authority. de丁] ‐ 」 Under Secretary to the(3overnment oflndia PH:-23071162 Directorate General of Foreign Trade, Department of Commerce, (Shri M.V. Singh, FTDO), Udyog Bhawan, New Delhr /′ θ ・子 f F. No.35011 16521201 3-Pl (Norms) Government of lndia Ministry of Chemical & Fertilizers Department of Pharmaceuticals Udyog Bhawan,New Delhi, Datedil干」une,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. 0118215014371AM-14|DES- 3/569 dated the 30/9/13 vide which application from M/s Hetero Drugs Ltd. was sentto this Deparlment for fixation of norms under para: 4.7 for the export of Pramipexole dihydrochloride monohydrate. 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)-2, 6-d iam i no-4, !,q;ftgtq y

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Case No.:9/33182-ALC4/2012 Parry Name:NEOGEN Meet No/Daii:qlSl - - Strtrrd;

CHEMICALS LIMITED ALC4l20l3 Approved 16.05.2013 HQ File RLA File Lic.No/Date:03 l07l 7358

biTe. Oate, :0lt82t05Ol0l 156/AM l3l :03t951040100683/AM l31 17.12.2012 , Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/ll7lz}ll-Ch. II dated 29.5.2011, it was decided to ratify norrns under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less: つ４ Export product Exp. Qty. Sl.No. Import items Qty. allowed 2-Bromo Iso Butyric Iso Propyl Ester (lsopropyl- 2-Bromo Isobutyrate/2- Bromo Isobutyrate D Isopropryl) l kg 1 Iso Butyric Acid 0.701 kg う４ Liquid Bromine 1.276 kg

Iso Propanol 1.078 kg RA may take appropriate action as per the decision of Norms Committee. 」

F No.3501 1/12812016-Pl (Norms) Government of lndia Udyog Bhawan, New Delhi, Dated: \ July, 2016 Office Memorandum Case of M/s Nectar Life Sciences Ltd. The undersigned is directed to referto DGFT U.O.No. 01l\2l50l204lAM-17lDES- 3/190 dated lhe 417116 vide which application from M/s Nectar Life Sciences Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Cefuroxime Axetil (DC Grade). 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 following details from the firm viz.-

Copy of drug manufacturing licence showing composition/content of API in the export product.
Copy of master-batch formula duly certified by Q.C. lncharge.

This issues with the approval of competent authority (RaJkumar) Under Secretary to the Government of lndia PH:- 23071162 (Shri M.V Singh, FTDO), Udyog Bhawan, New Delhi

⌒ F No.3501'1/63012014-Pl (Norms) Government of lndia Dated: l/une, 2016 Office Memorandum Case of M/s Hetero Drugs Ltd. The undersigned is dlrected to refer to DGFT U.O.No. 01182150110481AM- 15/DES-3/919 dated the 26112114 vide which application from M/s Hetero Drugs Ltd. was sent to this Department for fixation of norms under paru.4.7 for the export of Perindropril Tert.Butylamine. 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.- う４ This issues with the approval of competent authority. PH.- 23071162 S.No. lmport item Norms Recommended for 1 kq Export 1 Octahydro indole-2-carboxylic acid benzyl ester p- toluene sulphonate salt 1.B45kg 2 N-(S)- 1 -ca rbethoxvb utvl-L-ala n ine 0.9'16kq

４１１３（ ′ Mcet No/Date:16/82‐ ALC4/2013 121.112013 Lic NI 310520 whichever is less: :3 1 I 83 I 040 I 00(t 9 I AM 1 4 I :01/82/050/00470/AM14/ Export product Exp.Qtv. SI.No. lmport items Qtv. allowed Sodium Benzoate Micronised lkg Sodium Benzoate 1.01 kg RA may take appropriate action as per the decision of Norms Committee.

67 一Fつ― | (lase N().:136/6/82- Parり Nanlc KLl lMeet No/Datc:6/82- Status: IAI´(4/2()14 PLASTICiZERS L「D IALC4/2014 1Approved 129082014 1 1 1HQ Filc RIンA Filc tiC No/Datci0510382642 1Dclcr Datc: :01/82/050/()0538/AM15/ ()5/23/040/0()524/AM14/ 25032014 ‐ Decision:ln the light of wrltten comments received from Department of Chemicais and Petrochemicals lvidc their U O No 14010/36/2011/Ch ll dated 23 07 2014,it was declded to ratify norms under Para 4 7 1 10f卜lBP Vl as per details given below or as applied by the firm′ whicheveris iessi Export Product Ex port Oua ntitv S No lmport Product Quantity Allowed KANATOL― 1001 (PACKED IN l、334 NOS OF Hヽ4‐ HDPE DRUMS MADE OF HM‐ Hl)PF B1 0WING GRADF) PHTHALiC ANHYDRIDE 0 349 kg 2‐PROPYL HEPTANOL 0 590 kg ISO DECANOL 0 197 kg IINI HDPE DRUMヽMADF OF HM― HDPE BL(〕WING GRADE As per packing policy RA maV take appropriate action as per the decision of Norms Committee.

θフオ Ч θ i:. No.350 1 1 18241201 5-Pl (Norms) Governnrent of lndia ilinistry of Chemical & Fertilizers Udyog Bhawan, Neur Delhi Dated. 6 June 2016 Office Memorandum SubleCti― FI× ation of∩oril13 under para 4 7 of Hand 8ook of Procedures(Voll)2009-14 Case of M′ s Aarilindustries Ltd. The undersigned i$Jlrected to referto DGFT U O No 01/82/50/96′ AM‐ 17/DES― 3/129 dateclthe 23/5/16vにlc RA/hiCh application from～ 1/s∧artilndustries Ltd vvas sentto this Departillent for fixation of norms under para:4.7 forthe export of Budesonide.This departinent has exarnined tlle rnatter and the fo‖ owing norrlls are ftirntshed tinder para 4 7 of Hand Book of ProccllにlreS(VOll)2009-141- lnrport itent Norms Recommencied ＯＮ　　ｌＳ　　　・ 1011卜9F¥p9Ⅲ … _ 1 __ _1lQpettg 16「alpぃいydgyり19dniSO10ne This issues witlr the anproval of conrpetent authority (Ralkunlar) Under Secretary to the Goverininent oflndia PH:… 23071162 Directorate General of Foroi9n Trade Department of Comnnerce (Shrl M_∨Singh,FTDO), Udyo9 Bhawan,New Delヤ ll ⌒ 2

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Case No.:134/6ノ82‐

Party Name:PARAMOTJNT Meet No/Date:11/82‐ ALC4/2014 AROMACHEM PVT.LTD., ALC4/2014 ‐ 26.11.2014 Defer Date: : ln the light of written comments received from Department of Chemicals and Petrochemicals their u.o No. 14010/61l2OtOlCh ll dated 28.L.2ot4, it was decided to ratify norms under Para 4.7 HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Quantity S.No lmport Product Quantity Allowed 3ARVACROL l kg D―LIMONENE(LIMONENE, CITRUS TERPENE,ORANGE TERPENE,BRAZALIAN CITRUS TERPENE STANDARD CITRUS TERPENE ORANGE OIL) 3.20 kg may take appropriate action as per the decision of Norms Committee. 1鵠晶児 5α0053αAMl夕陽ち

Stn tu s: (lasr A pproved (lascヽo.:152/3/82-AL(:4/2014 Partゝ Na11lc AARTI INDUSTRIES l´ lヽ41TED Mect No/Datc 3/82- ALC4/2014 08052014 HQ Fiに 101/X2/()5()/()()156/Aヽ415′ RLA「ile t()3/94/040/()0708/AM14/ 1´ ic No/Datc 0310768714 Dcibr Datc 31()1 2014 and in consultation with technical para 4 7 of HBP as per details given Decision : Committee considered case as per agenda authority present in meeting decided to ratify norms under below or as applied by the firm, whichever is less: ‐ 繭品5面 lmport items Qty k l kg 1 0947 L-NARVAT.TNE | 1.123 RA concerned may take further necessarY action as per above decision of NC IT威1飩

o"/ {z- F. No.350'1 1138312015-Pl (Norms) Government of lndia Shastri Bhawan, New Delhi, Dated: March 17,2016 Office Memorandum Sub: - Fixation of norms under para 4.7- Applicaiion of M/s J.B. Chemicals & Pharmaceuticals Ltd. The undersigned is directed to refer to DGFT U.O. No. 01l92l50l424lAM-161DES-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) Andclex 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.No Description Quantity Description Quantity in gm Diffiam Sugar Free Lozenges in Raspberry/ Eucalyptus & MentholiHoney & Lemon/ ,Orange/ Double Mint flavours 100 lozenges Benzydamine hydrochloride 0.306 lsomalt ST―M 257 Cetylpyridinium Chloride Not needed as per DML ２一 A.ndolex Lozenges Sugar Free Mint 100 lozenges Benzydamine hydrochloride 0.306 lsomalt ST―M 258.60 2. This issues wtth the aDOrOVal of DlrectoL(Pharlrlュ lndustry)._ (Raj Kumar) Phone: 23071162 Uspi3-Pharma@nic.in (Shri MVSingh,FTDO),

ヘもう F. No.3501 1 /851 12015-Pl (Norms) Government of lndia Dated: June, 2016 Office Memorandum

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

14 Case of M/s Sirmaxo Chemicals (P) Ltd. The undersigned is directed to refer to DGFT U O.No. 0118215011667lAM- 16/DES-3/1758 dated the 213116 vide which application from M/s Sirmaxo Chemicals (P) Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Povidone lodine Topical Solution USP. This department has examined the matter and the followrng norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- DGFT is advised to call following detail from the firm viz:- 'l . Complete description of export product showing % content of Povidone lodine and available lodine in the export product. 2. Unit of expo( product is show in numbers. The same may be given in Kgs and Litres. 3. Detailed working on the requirement of import input. 2. (Ralkumar) ∪nder Secretary to the Government oflndia PH■23071162 (shn M v singh,FTDO), Udy。9 Bhawan,New Delhi

へ F No.3501 1161712015-Pl (Norms) Government of lndia Dated: 21 March,2016 Office Memorandum Sublect. - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case of M/s Globe Trotters Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01l12l50l737lAM- 16/DES-3/811 dated the 2018/15 vide which application from M/s Globe Trotters Pvt Ltd. was sent to this Department for fixation of norms under para: 4.7 for lhe 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) 2009-14.- DGFT is advised to call following details from the firm viz.-

Size fo the bottles to be exported/volume of syrup. 2 Copy of master-batch formula duly certified by Q.C. incharge.

(Ra,;ku ma r) PH - 23071162

ハゞ′M.g:た A LC4/2014 25092014 Status: Approved / 79 1Defer Date: IPart、NalllciS ‖c Decision : ln the Petrochemicals vide ratify norms under whichever is less: ‖ght of written comments received from Department of Chemicals and their U O No 14010/105/2011-Ch ‖dated 09 10 2014, it was decided to Para 4 7 of HBP vl as per detalls given belo、v or as apphed by the firm′ RA may' take appropriate action as per the decision of Norms Committee. "… … ″… : Export product Exp Qtv SI No lmport items Qtv allowed CAME crude (Methyl-2-arnino- -i-chlorohenzoate) OR 2-Amino- i-chlorohcrrzoic acid rnethy'l cstcr. crude l Kg 2-3-dichlorobenzoic acid Minimum 99% l.318 kg

年７字 ~冨続続甲調漑諄鞣" | 270 田蕊蕊薦iξ ~~蹄蹴蕊蔦高丁需需繭面F面「 received from Department of Chenlicals and 011-Ch.‖ dated 17.09.2014′ it was decided to deta‖s given below or as app‖ ed by the firm′ Export product Exp. Qty. Sl.No. Import items Qty. DiBu″l tin Diacetate(DBTDA) lKg 1 Tin Ingots 0.418 kg 2 Aluminium Grit/ Granules 0.071 kg ● フ Butene-l 0.542 kg 60/40 Mix Butyl Tin Chloride (60140 MBTC) lkg 1 Tin Ingots 0.447 kg 2 Aluminium GriV Granules 0.048 kg 3 Butene-1 0.368 kg 3F-200(Blend Of40%mono― butyl― tin 「Hchlo面de and 3.5%ofHF) lkg 1 Tin Ingots 0.199 kg 2 Aluminium GriV Granules 0.025 kg ０フ Butene-l 0.180 kg RA may take appropriate action as per the decision of Norms Committee.

oT ⌒ ヽ t\a F. No.3501 1 /76912015-Pl (Norms) Government of lndia Dated2jJune,2016 Office Memorandum

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

PH.- 23071162 Case of M/s Jagsonpal Pharmaceuticals Ltd' ,.-- a'' The undersigned is directed to refer to DGFT U.O.No. 01lg2l50l1175lAW 16/DES-3/1371 dated the 21t12115 vide which application from M/s Bharat Parenterais Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Mifepristone Tablests 200mg and Misoprostol Tablets 200mcg. 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 coA of Misoprostol Dispersion API from the firm from their forign supplier. 2. Department of Commerce.

⌒ 120 F.No.35011/175/2016-PI(Norms) Government oflndia Ministry of Chemical&Fertilizers Department of Pharrnaceuticals Udyog Bhawan,New Delhi, Dated: 」uly,2016 0ffice Memorandum SubieCt:― F破ation of norms under para 4 7 of Hand Book of Procedures(∨ ol l)2009- 14 Case of M′s Aarti Drugs Ltd. 丁he undersigned is directed to refer to DGFT U O No 01/82/50/338/AAll― 17/DES-3/246 dated the 8/7/1 6 vide which application from N1/s Aarti Drugs Ltd was sent to this Department for fixation of norrrns under parai 4.7 for the export of Clopidogre:Bisulphate.Thls department has exarYlined the rnatter and the fo‖ ovving norrns are furnished under para 4 7 of Hand Book of Procedures(Vol.|)2009-14:― 2 (Ralkumar) Under Secretary to the(3overnment oflndia PHi-23071162 Udyog Bhawan, New Delhi. S No lmport item Norms Recommended for 1kq Export 1 2-ch lorophenvl q lvcine 105 2 Methanol 3 27kq 3 Toluene 1 36kq 4 Methvlene dichloride 2 82kq 5 L― (十)_tartaric acid 0 70kq 6 Acetone 2.36kg 7 2-thiophene ethanol 0 707kg 8 Activated carbon 0.039kg

c+ Br F. No.3501'1/7791201 5-Pl (Norms) Government of lndia Dated:4]June, 20'16 Office Memorandum Case of M/s Shalina Laboratories (P) Ltd. The undersigned is directed to refer to DGFT U.O.No. 01l12l50l1435lAM- 16/DES-3/1406 dated the 1111116 vide which application from M/s Shalina Laboratories (P) Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Epiderm Cream 1Sgm and 30gm Tube. 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 for each export product. 2. PH:- 23071162

ヘ 0キ 1吻θ F. No.3501 1 /7701201 s-Pl (Norms) Government of lndia Dated:;fqJune, 2016 Office Memorandum Case of M/s Bharat Parenterals Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011166/AM- 16/DES-3/'1335 dated the 18112t15 vide which application from M/s Bharat Parenterals Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Fosfomycin Sodium 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.- 2 Under Secretary to the Government oflndia PH■23071162 Depanment Of Commerce, (Sh面M∨Singh,FTDO), Udyog Bhawan,New Delhi S No lmport item Norms Recommended 1 Fosfomycin Sodium 1.449gmlvial

｀0+ ‐ ‐=｀■、二_一ヽt41 ヘ Government of lndia Ministry of Chemicals and Fertilizers Department of Chemicals and Petrochemicals ダ／タ … ノ Sutted ttRCl今廿常¶雪 :1:1嘲1響ll」 r誅鷲Ь PI麗』T踏:鳥選出革 hydroxyphenyl)phthalirrllde (Advance Authorization No.0310794798 dated 23 03 2015) Ret UO No.01/83′ 50/548/AM16/DES‖ l dated 23.06.2015 `Mた胤骨 Ft∬響1謄[熟鳳肝Ъ P竃「δ認謙:置::lξ軍I調:x‰騎||∬:liぶdξ W norrnsI:l:‖ξ :::::1:11」〕賃 l::ス]:h:吾]:ll::1ョ and the Departrnent recornrnends the fo‖ owing pplicatlon. ltem Qllmp9は__________ l kg. PHENOL ANILINE Tltis issues with the approval of competent authority' (A.K. AGARWAL) Addl lndustrial Adviser-- Tel. No. 01G2338 1430 .,.','u sfi;.i Mahendglvit{ram sioq?,rl-;?(I,(DES-llJ) Q/? pG"t-T, Udvoq Bhawan'New Delhi-11' -.' 1-CH-ll dated1o.9.2015 IЪ戸 : ■■hisF4

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牝（ヘ F. No.3501 1 /767 1201 s-Pl (Norms) Government of lndia Dated:BgJune, 20'16 Offlce Memorandum Case of M/s Venus Remedies Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501117114M- 16/DES-3/1291 dated the 16112115 vide which application from M/s Venus Remedies Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Topotecan for injection 2.5m9 and 4.0m9. 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:- う乙 PH■23071162 (Shl M V Singh,FTDO), Udyog Bhawan,New Delhi S No lmport item Norms Recommended 1 Topotecan Hcl 2 909mg/2 5mg vial And 4 656mg/4 0mg val

^ 汐瀾震 F No.3501 1t81612015-Pl (Norms) Government of lndia UdyOg31雷ι皿,現l: Sutted L7規∬∬ぶ =ll:諄 L薔[:こ∬混 :早「譜 d Pr°CeduЮ S Ⅳ d⇒2009- The undersigned iS direCted tO refer to DGFT tJ O No 01/82ノ 50/1524ノANl― 16′ DES-3′ 1637 dated the 16′ 2/16 vide whiCh applicatiδ F~■om M/s U Square Lre 譴詢計 t可輛著模i劉榊WI響i提l獅櫨 Procedtires(∨011)2009-14: lmport item つ４ This issues with tlre approval of competent authority' Norms Recommended for 784. 411ni vial 1 (Ralkumar) Under Secretary tO the Gove「IFF':::キI:: Directorate Genera1 0f Foreign Trade, 爾∬節鱗il

´ ′ F. No.3501 1 177412015-Pl (Norms) Government of lndia Shastri Bhawan, New Delhi, Dated: July 5, 2016 Office Memorandum Sub: - Fixation of norms - Application of M/s J.B. Chemical & Pharmaceuticals Ltd. The undersigned is directed to refer to DGFT U.O. No. 011821050/01439/AM-16/DES-3 11597 dated 1510112016 forwarding an application of M/s J.B. Chemical & Pharmaceuticals Ltd. for fixation of norms against export of 1 composition of Difflam Brand Sugar Free lozenges and 2 compositions of DURO-TUSS dry cough 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: 2307 1 1 62lUspi3-Pharma@nic. in (Shri M V Singh, FTDO),Udyog Bhawan, New Delhi. (Rai Kumar) Product to be Exported Raw materials to be imported Ｓ．助 Description Quantity S NO Description Quantity in gm for 100 lozenges Difflam Blackcurrant Sugar Free Lozenges. Each lozenge contains Pholcodine 5.50 mg, Benzydamine Hydrochloridel.50 mg, Cetylpyridinium Chloride 1.33 mg mg and lsomalt ST-M 2141.64 mg 100 lozenges Pholcodine 0.561 2. Benzydamine hydrochloride 0.153 3. Cetylpyridinium Chloride 0.1356 4. lsomalt ST― M 214.164 2 Duro Tuss Dry Gough Lozenges Sugar Free Orange, Each lozenge contains Pholcodine 5.50 mg, Cetylpyridinium Chloride 1.33 mg and lsomalt ST-M 2141.64 mo. 100 1ozenges Pholcodine 5.61 mg 2. Cetylpyridinium Chloride 0.1356 3. lsomalt ST― M 214.64 3. Duro Tuss Dry Cough Lozenges Sugar Lemon. Each lozenge contains Pholcodine 5.50 mg, Cetylpyridinium Chloride 1.33 mg and lsomalt ST-M 2141.64 mg. 100 !ozenges Pholcodine 5.61 mg 2 Cetylpyridinium Chloride 0。1356 3. lsomalt ST¨ M 214.64

c F No.35011/779l2015-Pl (Norms) 'l Government of lndia Dated:p2June, 2016 Office Memorandum Case of M/s Shalina Laboratories (P) Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182150111431AM- 16|DES-311277 dated the 16112115 vide which application from M/s Shalina Laboratories (P) Ltd. was sent to this Department for fixation of norms under para:4.7 for the export of Epiderm Cream 't 5gm and 30gm Tube. 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 ca‖ copy Of Master― Batch formula for each export product ｀フ// 2. PH:-23071162 Depanment Of Commerce, (Shn M V Singh,FTDO), Udyo9 Bhawan,New Delhi

F No.3501 117761201s-Pl (Norms) Government of lndia Dated: June,2016 Office Memorandum Case of M/s Shasun Pharmaceuticals Ltd. The undersigned is directed to refer to DGFT U.O.No. 01lB2l50l1253lAM- 16|DES-311472 dated the 1211116 vide which application from M/s Shasun Pharmaceuticals Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Gabapentin Tablets USP 800m9. 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 a:- DGFT is advised to call copy of Master-Batch formula from the firm. 2. PH- 23071162

⌒ F. No.3501 1 /77612015-Pl (Norms) Government of lndia Dated: June,2016 Office Memorandum Case of M/s Shasun Pharmaceuticals Ltd. The undersigned is directed to refer to DGFT U.O.No. 01lB2l50l1254lAM- 16/DES-3/1273 dated the 16112115 vide which application from M/s Shasun Pharmaceuticals Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Gabapentin Tablets USP 600m9. 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. 2. PH:- 23071162

^ ヽ F. No.350'1'1 /7921201 s-Pl (Norms) Government of lndia Dated:.1!une, 2016 Office Memorandum

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

Case of M/s Curetech Skincare. The undersigned is directed to refer to DGFT U.O.No. 01l\215011227lAM- 16/DES-3/1487 dated the 1211116 vide which application from M/s Curetech Skincare. was Sent to this Department for fixation of norms under para.4.7 for the export of (1)Bacitracin with Neomycin Sulphate Ointment 159m, (2)Nystatin Ointment BP 1Sgm. 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 complete set of application on the prescribed proforma showing export products, export quantity and per unit requirement of input for each of the two export products. 2. (Rajku ma r) PH:- 23071162 Department of Commerce. (Shri MV Singh,FTDO),

^ /

´ 〓・八ヘ Governrnent ofindia Ministry oi Chernicals attd Fert‖ 2ers Depattment of Chemicale and Petrochemicals 「百ポ驚器響ツク 1鵠ギ幽働― 1 4,4-Met r Dialkyamino- :・ 1225/Unili 4200 /CN" i3.3%PI “ Jゴ五寧繁=～凛犠二=‐ [ This issues with the approval of competent autnority 2冬笹競__ ……………―― 一一 rn Cata:yst― (2020 Carbon 。イ慨鰹膠幽L爾孵懺轟トー髪多il唾Ⅲ亜菱亜壼嘔独菫III理璽亜画 :f~ z ダ髪肇生_ 0′ 7200 kg l O、00013 1 i3,71,19些i狙■…… | :Suttded£ l Rヽ″ S DOPED 43515 SubieCti Advance Authorizatton application from M/s Dorf‐ Ketal Chemicals india Pvt Ltd.for the import of raw materia:agalnstthe export of Polymer Addに ives‐ NlN, Dialkyarnino‐ Diphenlmethane― UOP No.225ノUnilink 4200/CN… 2357/Stock‐ 2357) . etc. M/s_Dorf― Ketal Chernicals india)ヽ. Ltd.have sub■litted present applications for the irnpclrt of ra■v rnaterial against the export of Chbrnical‐ Polソmer Additives The application ttas been exanlined iarld the Depattment recoFnmends the following nOrFnS fOr tれe present Advance Atlthorization applications :Qty i 二 rギ| ～― ― ― ¨ ― ― ― 一 ― ― ¨ ― ― ― ― ― :～1lli～1:111:[:::1… … 1 体
｀イ Addl.industrial Adviser Tel.No、011-23381430 dated 15.12,2015 l kg

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F. No.3501 1/787/201s-Pt (Norms) Government of lndia Shastri Bhawan, New Delhi, Dated: July 14,2016 Office Memorandum sub: - Fixation of norms - Application of M/s Bliss lndasi Lifescience pvt. Ltd. The undersigned is directed to refer to DGFT U.o. No. o1lg2to5olo1353/AM-16/DES-3 /1562 dated 1510112016 fonivarding an application of M/s Bliss lndasi Lifescience pvt. Ltd. for fixation of norms against export of Fosfomycin for lnjection 1 gm. 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 This issues with the approval of Director (pharma lndustry). Phone: 2307 1 1 62lUspi3-Pharma@nic. in (Shri MVSingh, FTDO), (Rtt Kumar) Product to be Exported Raw material to be imported Desciption Quantity Description Quantity per 100 vials Fosfomycin for lnjection 1 gm 1 00 vials Fosfomycin sodium EP 134.50 gm

iCase No.:239/13/82- IA LC4/2014 :Pany Nanle:DORF―KETAL ICHEMICALSINDIA :PVT.LTD. IMeet No/Date:13/82- :ALC4/2014 11912.2014 Status: Approved :Defer Date: IHQ File l:01/82/050/01242/AM15/ IRLA File r:03/94/040/00390/AM15/ :Lic.No/Date:0310787602 10408.2014 :Decision:in the“ ght Of Wtttten comments received from Department Of ChemicalS and Petrochemicals lvide thcir uiO No 14010/176/2011/Ch‖ dated 10 10.2014′ t was decided to ratify norms under Para 4.7 of lHBP Vl as per deta‖ s given below or as applied by the firm′ whicheveris less: Export Product Export Quantity S.No lmport Product Quantity Allowed Polymer Aclclitives - Bis (N-A Ikylam inocycohexyI) rnethane Tracle Nante: Clearlirrk 1000 l kg PAC-2M(4,4- Methylenebi Scyclo Hexanamine),SynOnym: Bis(paranlinocvclohexvl) 0.665 kg 2. McthyI Etllyl Kelone/ MEK 0.798 kg 3. Catalyst: 30% Platinum on carbon por,vder (on dry' basis) 0.00022 kg , .R1T:v l:l: 'pp,.11'r1t: 1'liol '-' ?-"_' the decision of Norms Committee.

´ ´

F No.3501 1177912015-Pl (Norms) Government of lndia Dated:1/une,2016 Office Memorandum Case of M/s Shalina Laboratories (P) Ltd. The undersigned is directed to refer to DGFT U.O.No. 01lB2l50l1381lAM- 16/DES-3/1476 dated the 1211116 vide which application from M/s Shalina Laboratories (P) Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Epiderm Cream 1Sgm and 30gm Tube. 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 for each export product. 2. PH.- 23071162

ヘ F. No.3501 1178912015-Pl (Norms) Government of lndia Shastri Bhawan,New Delhi, Datedi」uly 18,2016 Office Memorandum Sub: - Fixation of norms - Application of M/s Jodas Expoim Pvt. Ltd., New Delhi. The undersigned is directed to refer to DGFT U.O. No. 0118210501012941AM-16/DES- 311491 dated 1210112016 fonryarding an application of M/s Jodas Expoim Pvt. Ltd. for fixation of norms against export of Temozolomide Capsules in 5 m9,20 mg, 100 mg, 140 mg, 180 mg and 250 mg strengths and (ii) Carboplatin lnjections in 50 mg/Sml vial, 100 mg/10 ml vial, 150 mg/15 ml vial, 450 mgl45 ml vial and 600 mg/60 ml vial. This department has examined the matter and the following norms are furnished: - (A)Export Product Temozolomide Capsules: - Strength 5 mq 20 rlng 100 rnq 140 rng 180 rng 250 rng Quantity of Temozolom ide for 1000 Capsules 5。100 gm 20.400 gm 102.000 gm 142.800 0m 183.600 0m 255.000 0m (B) Export Product Carboplatin lnjections This issues with the approval of Director (Pharma lndustry). Phone: 2307 11 62lUspi3-Pharma@nic.in (Shri MVSingh,FTDO), Strength 50 rng/5 rnl vlal 100 rng/10 ml vial 150 rng/15 ml vial 450 rng/45 ml vlal 600 rng/60 ml vial Quantity of Carboplatin for 100 vials for lniection 5.50 gm 11.00 gm 15.75 gm 47.25 gm 63.00 gm 2.

o+ 7{ F. No.3501 1/78812015-Pl (Norms) Government of lndia Shastri Bhawan, New Delhi, Dated: July 14,2016 Office Memorandum Sub: - Fixation of norms - Application of M/s Scott-Edil pharmacia Ltd. The undersigned is directed to refer to DGFT U.o. No. o'ttl2losotol4oTlAW- 16/DES-3 /1533 dated 1410112016 fonrvarding an application of M/s scott-Edil Pharmacia Ltd. for fixation of norms against export of Meropenem 1 gm lnjection. This department has examined the matter and the following norms are furnished: - This issues with the approval of Director (pharma lndustry). (Shri MVSingh,FTDO), Phone: 23071 1 62lUspi3-pharma@nic.in Product to be Exported Raw material to be imported Description Quantity Description Quantity per 100 vials Meropenem t gm lnjection (each vial contain Meropenem Trihydrate equivalent to 1gm Meropenem) 1 00 viais Meropenem Trihydrate 125.501 gm

F. No.350 1 1 16512016-Pl (Norms) Government of lndia Dated: June, 2016 Office Memorandum Case of M/s Cadila Healthcare Ltd. The undersigned is directed to refer to DGFT U.O.No. O1lB2l5Ot1772tAM- 16/DES-3/45 dated the 614116 vide which application from M/s Cadila Healthcare Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Paroxetine Hcl. 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 PH.- 23071162 S.No. lmport item Norms Recommended for 1kg Export 1 Piperidine alcohol methyl-4-(4-fluoro [Trans- 1 -N-methyl-3-hyd roxy phenvl) piperidine 0.B1kg 2 Sesamol 0 55kq 3 Dimethyl sulfoxide 1 916kq 4 lsopropyl alcohol 2 523kq 5 Methanol 1.367kq 6 Acetone 7 195kQ

義 F. No.3501 1 179912015-Pl (Norms) Government of lndia Shastri Bhawan, New Delhi, Dated: July 18,2016 Office Memorandum Sub: - Fixation of norms - Application of M/s Mediclone Biotech Pvt. Ltd. The undersigned is directed to refer to DGFT U.O. No. 011821050/01339/AM16/DES- 311425 dated 1110112016 forwarding an application of M/s Mediclone Biotech PvL Ltd. for fixation of norms against export of Carmustine lnjection 100 mg/30 ml vial. This department has examined the matter and the following norms are furnished: - Product to be Exported Raw material to be lmported Description & Pack Size Quanuty Description Quantity for 100 viais Carmustine lnjection 100 mg per 30 ml vial 1 00 vials Carmustine 10.500 gm 2. This issues with the approval of Director (Pharma lndustry). Phone: 2307 1 1 62lUspi3-Pharma@nic.in (Shri MVSingh,FTDO),

F. No.3501 1176712015-Pl (Norms) Government of lndia DatedP$June,2016 Office Memorandum Case of M/s Venus Remedies Ltd. The undersigned is directed to refer to DGFT U.O.No. 0.1/82/50/1 399/AM- 16/DES-3/1594 dated the 1511116 vide which application from M/s Venus Remedies Ltd. was sent to this Department for fixation of norms under para.4.7 for the export of Ornitox (59m/10m1) L-Ornithine L-Aspartate 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:- つ ‘ (Rajku ma r) PH.- 23071162 S.No. lmport item Norms Recommended 1 L-Ornithine L-Aspartate 5.5qm/10m1 Vial

F. No.350 1 1 1767 1201 s-Pl (Norms) Government of lndia Dated:{} June, 2016 Office Memorandum Case of M/s Venus Remedies Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011401/AM- 16/DES-3i 1538 dated the 1411116 vide which application from M/s Venus Remedies Ltd. was sent to this Department for fixation of norms under parc'. 4.7 for the export of Docetaxel lnjection Concentrate 80mg/2.0m1, 20mg/0.5m1, 120m9/3.0m1. 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 Under Secretary to the(3overnment oflndia PH:-23071162 Depanment Of Commerce, (Shtt M.V Singh,FttDO), Udyog Bhawan,New Delhi S No lmport item Norms Recommended 1 Docetaxel Anhydrous 22.Omg/20mg vial And 88 0mg/80mg vial And 132.Omg/120mg vial

F. No.3501 1 178912015-Pl (Norms) Government of lndia Shastri Bhawan, New Delhi, Dated: July 18, 2016 Office Memorandum Sub: - Fixation of norms - Application of M/s Jodas Expoim Pvt. Ltd., New Delhi. The undersigned is directed to refer to DGFT U.O. No. 0118210501014251AM-16/DES- 311517 dated 1210112016 forwarding an application of M/s Jodas Expoim Pvt. Ltd. for fixation of norms against export of (i) Cefuroxime Sodium for lnjections 750 mg, (ii) Cefuroxime Sodium for lnjection 1.5 gm, (iii) Ceftazidime 1 gm lnjection and (iv) Polymyxin B for lnjection 5, 00,000 units/vial. This department has examined the matter and the following norms are furnished: - (A)Export Product : - Cefuroxime Sodium for lnjection Strength 750 rng 1.5gm Quantity of Cefuroxime Sodium against 100 vials 86.774 gm 173.548 gm (B) Export Product : - Ceftazidime 1 gm lnjection Strength 1.O orn/vlal Quantity of Ceftazidime against 100 vials of 1 qm for lniection 1.281 9m (C)Export Product:- Polymyxin B for lnjection 5,00,000 units/vial Strength 5,00,000 units/lniectiOn Quantity of Polymyxin B Sulphate against 100 vials of 5,00,000 units/!njection 6.2gm This issues with the approval of Director (Pharma lndustry). Phone:23071162/Uspi3-Pharrna@niC.in (Shri MVSingh,FTDO),

ル 9ヽ? F No.3501 117012016-Pl (Norms) Government of lndia Dated: June,2016 Office Memorandum

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

Case of M/s lnchem Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 01l92l50l1907lAM- 16/DES-3/42 dated the 514116 vide which application from M/s lnchem Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Amisulpride. 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 following detail from the firm viz:-

Complete technical details as per appendix-33 indicating mol.wt. of each input and output product.
o/o yield on molar basts for single step reation.
Copy of technical literature in support of yield envisaged. うこ (Raikumar) ∪nder Secretary to the Government ofindia PH■23071162 (shn M∨s ngh,FTDO), Udyog Bhawan,New Delhi

４／鰯 F. No.3501 118451201s-Pl (Norms) Government of lndia Dated: 10 June, 2016 Office Memorandum

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

Case of M/s Reannon Pharmaceuticals. The undersigned is directed to refer to DGFT U.O.No. 01lB2l50l1669lAM- 16/DES-3/1748 dated lhe 2/3116 vide which application from M/s Reannon Pharmaceuticals. was sent to this Department for fixation of norms under para: 4.7 for the export of Renontrikal injection (aprotinin 10,000 lU) Lyophilized injections. 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 PH:- 23071162 (Shri MV Singh,FTDO), S.No. lmport item Norms Recommended for 1 kq Export 1 Aprotin in 2.244sm11000 vials

夢 F. No.350 1 1 1512016-Pl (Norms) Government of lndia Dated: 6 June, 2016 Office Memorandum 14 Case of M/s Mylan Labs Ltd. The undersigned is directed to refer to DGFT U O No 01182150/1691/AM- 16/DES-3/1801 dated the 1513116 vide which application from M/s Mylan Labs Ltd. was sent to thjs Department for fixation of norms under para: 4.7 for the exporl of (1 S,4R)-4-[(2-Amino-6-Chloro-5-Formamide-4-Pyrimidi nyl)Amino]-2- Cyclopentene-1-Methanol. 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 item Norms Recommended for lkg Export 1 Vince lactam '1 298kq 2 L(+)tartaric acid 0.519kq 3 Triethylamine 1.142kq 4 N-(2-amino-4,6-d ichloro-5-pvrimidinyl) formamide 0 764kq 5 D(-) tartaric acid 0 78kq 6 Sodium borohvdride 0 226kQ 7 Methanol 4 53kq 8 lsopropyl alcohol 440k

Case No.:147/13/82‐

ALC4/2014 Party Name:SHIV PROTEINS ion : The committee decided to ratify the norms based on the recommendation of of C&PC Chemicals vide letter No.14010/17/2014-Ch― |l dt. 9.7.2015 as per deta‖ s below or as applied by the firm whichever is less:- & Meet No/Date17/82‐ Lic No/Da`:56,Ю004362 Export product Qty. lmport items Qty in kg Soya Lecithin (Feed Grade) lkg Liquid lecithin(Non Edible Grade) 101 may take further action accordingly.

F. No.3501 1 /85912015-Pl (Norms) Government of lndia 7b3, s+q Dated:pa June, 2016 Office Memorandum Case of M/s Celogen Pharma (P) Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82150/1598/AM- 16/DES-3/1761 dated the 213116 vide which application from M/s Celogen Pharma (P) Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Hi trisulf(Sulphadimethoxine & trimethoprim 30% Powder). 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:- つ４ PH- 23071162 S.No lmport item Norms Recommended 1 su lphad imethoxine 25.25qm1100sm Sachet

わ77 F. No.3501 116812016-Pl (Norms) Government of lndia Dated: June,2016 Office Memorandum Subject. - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol l) 2009-14 Case of M/s Fresenius Kabi Oncology Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011681lAM- 1 6/DES-3/1829 dated the 1513116 vide which application from M/s Fresenius Kabi Oncology Ltd. was sent to this Department for fixation of norms under para: 4.7 fot the export of lrinotecan Hcl injections 500m9, 300m9, 100m9, 40m9. 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 following details from the firm viz:-

Complete technical details as per appendix-33 for the manufacture of irinotecan Hcl 3H2o (APl)showing mol.M., % yield on molar basis for each step.
Consumption-coefficient of R.M for l kg APl.
% wastage claimed on API in the manufacture of injections of different strength/vial size. 2 This issues with the approval of comp Under Secretary to the Government ofindia PHl-23071162 D reёtorate General of Foreign Trade, (Shtt M∨Singh,FTDO), Udyog Bhawan,New Delhi

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F No.3501 1/85012015-Pl (Norms) Government of lndia Dated: 10 June,2016 Office Memorandum Sub.lect: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s Sentiss Pharma (P) Ltd. The undersigned is directed to refer to DGFT U.O.No. 01lB2l50l1678lAM- 16/DES-3/1737 dated the 213116 vide which application from M/s Sentiss Pharma (P) Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Visallergel eye drops 0.2"/.,2.5m1 . This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14:- DGFT may therefore advise the firm to furnish valid DML for 2.5m1 packsize export. 2. (Rajkumar) PH.- 23071162

F No 35011/847ノ2015-PI(Norms) Government oflndia Ministry of Chemical&Fertilizers Department of PharmaceuJcals Dated: 10 June, 2016 Office Memorandum Case of M/s Shree Life Sciences (P) Ltd. The undersigned is directed to refer to DGFT U.O No. 01182150116041AM' 16/DES-3/1745 dated the 213116 vide which application from M/s Shree Life Sciences (P) Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Phosphocreatine 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 following details from the firm viz:-

Copy of valid drug manufacturing licence for above export.
Size of the vials to be exported.
Justification/working on the quantitative requirement of API

(Rajkumar) PH:-23071162 Depanment Of Commerce, (shn M∨singh,FTDO), Udyo9 Bhawan,New Delhi

摯I黎騨9

Case No.:47/6/82-ALC4/2014

Case No.:47/6/82-ALC4'2614 PirT'ヽよ118:ζ i ёk6もPIヽbiA IMeet No/Date:6/82- IStatusl l

:ALC4/2014 1Approved lLlヽ41TED 129082014 1 1 )- i.oilszlo-solo0449/AN,ll5/:O3l95l040l0(:|944lNMl4l:03.04.2014 :1 :^、l^′ 1ヽ0+0・n :01/bZ/UDU/UU44ソ/ハ1ヽ′liD/ Vυ ′ノ′′ViV′ Vヽ′´''●｀…・・・ IDecision:in the light Of wntten comments reCeived from Department of Chemicals and Petrochemicalsi ● , 1● : ^… ―■^rDへro/17^f: vide their:U'o No. 14010/2 l2otzlch ll dated 2!.05.201'4, it was decided to ratify norms under Para 4.7 of . , ^n ;;; "rlt o"t details given below or as applied by the firm' whichever is less: YCL′OHEXANOLE RA mavねke ap「o"試e ttOnぉpg tte dedgon J NormsComttea

F. No.350 1 1 17681201 s-Pl (Norms) Government of lndia Dated: June, 2016 Office Memorandum 14 Case of M/s Alembic Pharmaceuticals Ltd. The undersigned is directed to refer to DGFT U.O.No. 01l92l50l1213lAM- 16/DES-3/1368 dated the 21112115 vide which application from M/s Alembic Pharmaceuticals Ltd. was sent to this Department for fixation of norms under para'. 4.7 for the export of Benzathine Pencillin 2.4 Mega 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'.- 2 (Rajkumar) PH.- 23071162 (Shri M V. Singh, FTDO), S.No. lmport item Norms Recommended 1 Benzathine Benzvl Penicillin Sterile lP/BP 2.52BOU/1 000 vials

F. No.3501 116612016-Pl (Norms) Government of lndia Dated: June,2016 Office Memorandum Case of M/s Malladi Drugs & Pharmaceuticals Ltd. The undersigned is directed to refer to DGFT U.O.No. 01l32l50l1799lAM- 16/DE5-3/44 dated the 6/4/16 vide which application from M/s Malladi Drugs & Pharmaceuticals Ltd. was sent to this Department for fixation of norms under para. 4.7 for the export of 4-methyl-5-phenyl-2-oxazolidinone(Racemic Oxazolidinone). 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 following details from the firm viz:-

Complete technical details as per appendix-33.
Past productions vis-d-vis actual consumption of imported inputs duly certified by Central Excise Authorities. 2 PH:- 23071162 (Shri MV Singh,FTDO),

F No 3501115571201s-Pl (Norms) Government of lndia Dated: $ July, 2016 Office Memorandum Case of M/s Metrochem API Pvt. Ltd. The undersigned is directed to refer to DGFT U.O No 011121501257|AM-17/DES- 31259 dated the Bl7l16 vide which application from M/s Metrochem API Pvt Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Omerazole Pellets 7.5%. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14.- lmport item mtoi lkq E 3,5-Lutidine 008484k Methylene chloride 0lqQzl(g Methanol 02954k Acetic acid 011475k ! t g_o_?skg_ Ammonium Qlz!?t!L 004534 2 PH'.- 23071162 l methvl cellulose(HPMC― E」

y,″`,マ『ζ LABORATORIES PVT.LTD., lALC4/2013 | :HQ File | |:01/82/050/00875/AM14/ : :E)ecision:in the light of wtttten comments received from Department of Chemicals and Petrochemicalsi l ,vide their U.O No.14010/105/2011-Ch‖ dated 21.112013′ it was decided to ra●fy norms under Para 4.7 ofi : IHBPvl as perdetallsg市en below or as applied by the irm′ whicheveris less: : '1ヽ κ : Export product Exp Qtv. SI.No. lmport items Qty. allowed 2-ⅣIcthoxy-6‐ chlorotoluene/3‐ Chloro― 2-methylanisole CAS No.:3260-88-6 3-Chloro-2-methylani line CAS No.:87-60-5 1 20 kg 2 Sodiunl nitrite CAS No.:7632-00-0 0 587 kg RA may take appropriate action as per the decision of Norms committee. ，（、 1
耐~電

ヘヽ F. No.350 1 I 167 12016-Pl (Norms) Government of lndia Dated: June, 2016 Office Memorandum Case of M/s Halcyon Labs (P) Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011845 & 1846/AM-16/DES-3/41 &47 dated the 514116 &614116 vide which application from M/s Halcyon Labs (P) Ltd. was sent to this Depaftment for fixation of norms under para. 4.7 for the export of (1)Betamethasone Dipropionate, (2)Betamethasone Sodium Phosphate, (3)Clobetasol Propionate. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14.- 2 (Rajkumar) PH.- 23071162 (Shri MV Singh,FTDO), S.No. Export item S.No lmport item Norms Recommended for 1kq Export Betamethasone Dipropionate 1 Betamethasone 0.868kq 2 Triethyl orthopropionate OR Tri methyl orthopropionate 0.77k9 2 Betamethasone sodium phosphate Betamethasone 0.7Bkg 3 Clobetasol propionate Betamethasone 1.00kq 2 Triethyl orthop rop ionate OR Trimethvl orthopropionate 0.8B5kg

F. No.350 1 1 11341201 6-Pl (Norms) Government of lndia Dated: tSJuly, 2016 Office Memorandum

subject: - Fixation of norms under para 4.7 of Hand Book of procedures

(Vol.l) 2009-14 Case of M/s Saurav Chemicals Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501291/AM-17/DES-3/197 dated lhe 417116 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 Loxoprofen sodium Hydrate. 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. PH- 23071162 S.No. lmport item Norms Recommended for 1kg Export 1 2-(4-bromomethyl) phenyl propionic acid 1.315kq 2 Methyl-2-oxocyclopenta ne carboxylate 0.B5kq

F No.3501 1 113212016-Pl (Norms) Government of lndia Dated: t$ Juty, 2016 Office Memorandum Subject. - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s Optimus Drugs (P) Ltd. The undersigned is directed to refer to DGFT U.O.No. 01lB2l5Ol265lAM-17/DES- 3/180 dated lhe 417116 vide which application from M/s Optimus Drugs (P) Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Sofosbuvir. 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 PH:-23071162 (Shri M.V Singh, FTDO), S.No lmport item Norms Recommended for 1kq Export 2-deoxv -2-fl u oro-2 -c-methyl u rid i ne 0.90kq 2 N-[(S)-(2,3,4,5,6-Penta fluoro phenoxy) phenoxy ploqplllyll_L:al_anine __ 1.92k9

F. No.350 1 1 18691201 5-Pl (Norms) Government of lndia アタ9 Dated: 24 May,2016 Office Memorandum 14 Case of M/s Suven Life Sciences Ltd. The undersigned is directed to refer to DGFT U O No. 0118215011692/AM- 16/DES-3/1739 dated the 2t3t16 vide which application from M/s Suven Life Sciences Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of (2-chloro-5-iodophenyl)-(4-fluoro phenyl)-methanone. 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 (Ralkumar) PHi-23071162 S No lmport item Norms Recommended for 1kq of export 1 Ethvl anthran‖ ate 0 963kg 2 Potassium iodide 0 713kg 3 Potassium iodate 0 419kg 4 Oxalyl chloride 0 509kg 5 Fluoro benzene 2 498kg

o? @ F No.35011117412016-Pl (Norms) Government of lndia Dated l{ Juty, 2016 Office Memorandum Case of M/s Divi's Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011584/AM-16/DES- 31242 dated lheBl7l16 vide which application from M/s Divi's Labs Ltd. was sentto this Department for fixation of norms under para'. 4.7 for the export of Naproxen. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- lmport item Norrns Recommended foi '1kq E QL-lgprgrq!- -D-Glucamine 00882k Acetic acid 054k Methanol 202k

toluene .qq_4!s_ 2 This issues with the approval of competent authority PH - 2307 1162 Department of Commerge,

6+,- F No 35o 11t136t2016-Pt (Norms) 6r Government of lndia Dated: f(July, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures

(Vol.l) 2009-14 Case of M/s Virupaksha Organics Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501240/AM-1 T IDES-31213 dated the 617116 vide which application from M/s Virupaksha Organics Ltd. was sent to this Department for fixation of norms under para. 4.7 for the exporl of Daclatasvir Dihydrochloride. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol l) 2009-14.- S No lmport item Norms Recommended for 1kq Export 1 4,4-Bis(2-bromoacetvl)biphenvl 1 00kg 2 MOC― L―Valine 0.55kg 3 N―(3-dimethyl aminopropyリー N―ethyl carbodiinlide Hcl 0 60kg 4 N-(te rt- B Lrtylca rbonvl )- L-prol i ne 1 1 5kcI 2. (Rajkumar) PH'.- 23071162

ハ F No 35011113112016-Pl (Norms) Government of lndia Department of Pharmaceutica ls Dated: \Bluty, 2016 Office Memorandum

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

Case of M/s Vision Drugs (P) Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501270/AM-16/DES- 3t181dated lhe 417116 vide which application from M/s Vision Drugs (P) Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Homo Veratronitrile. 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.- SNo lmport item Norms Recommended for 1kg Export 1 veratrole 1 231k9 2 Sodium cyanide 0 90k9 3 Paraformaldehyde 0.423k9 4 Methanol 0 46k9 5 Chloroform 1.385kg つ乙 Under Secretary to the Directorate General of Forergn Trade, (Shri M.V Singh, FTDO), Udyog Bhawan, New Dellti (Ralkumar) Government of lndia PH:-23071162

ヘ Government of lndia fuiinistry of Chemicals and Fertilizers Department of Chemicals and Petrochemicals ≦P/Aノo. SubieCt:Advance AuthottzaJon appllcauon from M/s.Clean Science and Technology Pvt.Ltd. forthe import of raw mate面al againstthe export of 4-METHOXY ACETOPHENONE(4 MAP)/ACETYL ANISOLE 99%PURITY. lAdvance Authorization No.311006572o dated 23.10.2015) (Advance Authorization No.3110065632 dated 16.09.2015) Ref: U.〇.No.01/82ノ050/01419/AM-16ノDES― l‖ ノ1553 dated 14.01.2016 U.〇.No.01ノ82/050/01416/AM-16ノDES― l‖ ノ1530 dated 12.01.2016 Mノs. Clean Science and ttechnology Pvt. Ltd. have submitted present applications for th9 im16rt of raw matettal against the export of 4-METHOXY ACETOPHENONE (4 MAP)ノACETYL ANISOLE 99%PURI丁Y. !he application have been exanlined based on the addition inforFnatiOn furnish by the firrn. The Department recornrnends the fo‖ owing norrFIS fOr the present Advance Authorization application. Item of Ex Qtv Item cf lmport Qty 4¨METHOXY ACE丁OPHENttNE(4 MAP)/ACETYL ANISOLE (PURITY 99%MINIMUM). l kg. 1.PHENOXY MEttHANE/ANISOLE (PURITY 93%MAXIMUM) 0.990 kg 2.ACETIC ANHYDRIDE 0.755 kg This issue with the approval of competent authority' Addl.industrial Adviser Tel.No.011-23381430 (A.K.AGARulAL) der ○/o Deptt.of C&PC U.〇 . No. IcH_ll(vOl.― |)dated 16.2.2016 冤筆

^ F No.35011/19/2016-PI(Norms) Government oflndia Ministry of Chemical&Fertilizers ´ ) 一面今 Dated: June, 2016 Office Memorandum Subject. - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case of M/s Encure Pharmaceuticals Ltd. The undersigned is directed to refer to DGFT U O,No. 01lB2l50l1725lAM- 16/DES-3/1904 dated the 30/3/16 vide which application from M/s Encure Pharmaceuticals Ltd. was sent to this Department for fixation of norms under para. 4.7 for the export of Dexketoprofen Trometamol. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol. l) 2009-1 4.- (Ralkumar) PH:-23071162 2. S No lmport item Norms Recommended for 1kg Export 1 3-( 1 -cyanoethyl) benzophenone 1.82kg ・2 N-Octyl-D-glucamine 0 36kq

0'l Lp- ,-
F. No.350 1 1 16412016-Pl (Norms) Government of lndia Dated: June, 2016 Office Memorandum 14 Case of M/s lnd. Swift Labs Ltd. The undersigned is directed to refer to DGFT U O No. 0118215011705/AM- 16/DES-3/1800 dated the 15t3t16 vide which application from M/s lnd Swift Labs Ltd was sent to this Department for fixation of norms under paru'. 4.7 for the export of Atorvastatin Calcium. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14.- 2 (Rajkumar) PH.- 23071162 (Shri M V. Singh, FTDO), S No. lmport item Norms Recommended for 1kg Export 1 Methvl isobutyl acetate 1.423kq 2 Beta alanine 0.100kq 3 3-ethyl-5-(2-hyd roxyethyl)-4-methyl th iazoliu m bromide 0.262k9 4 lsopropvl alcohol 5.60k9 5 ( R-C is)- 1, 1 -d i m ethylethyl-6-cya nomethyl-2,2- d imethyl- 1, 3-d ioxane-4-acetate 0.708k9 6 Tert. Butyl methyl ether 2.7Bks

化 F. No.350 1 1 11341201 6-Pl (Norms) Government of lndia Dated: lSJuly, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures

(Vol.l) 2009-14 Case of M/s Saurav Chemica)sfid.--- / The undersigned is directed to refer to DGFT U.O.No. 011821501289/AM-171DES-31225 dated the 617116 vide which application from M/s Saurav Chemicals Ltd. was sent to this Department for fixation of norms under para. 4.7 for the export of Dexketoprofen Trometamol. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14'.- 2. PH'.- 23071162 S No. lmport item Norms Recommended for 1kq Export Ketoprofen 15 2 N-octvl-D-Glucamine 0 3 Tromethamine 036k

F. No.350 1 1 1137 1201 6-Pl (Norms) Government of lndia Dated: lfJuly, 2015 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures

(Vol.l) 2009-14 Case of M/s Shree Jaya Laboratories Ltd. The undersigned is directed to refer to DGFT U.O.No. 01l82t50t267lAM-171DES-31223 dated the 617116 vide which application from M/s Shree Jaya Laboratories Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of 3,4 Dimethoxy-2-Chloromethyl Pyridine Hcl. 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 SNo lmport item Norms Recommended for 1kg f4qrt Maltol 0.91kq 2 Soda ash 3.23kg 3 Phosphorus oxych loride 1.64k9 4 Hvdroqen peroxide 2.1 6kq 5 Chloroform 1.035ks 6 Toluene 0.650ks 7 Acetone _a B19!g- 8 Methvlene dichloride 0.986ks 9 Methanol 1 327kg

ハ F No.350 11 I13212016-Pl (Norms) Government of lndia Deparlment of Pharmaceuticals Udyog Bhawan,New Delhi, Datedilb」uly,2016 Office Memorandum Case of M/s Optimus Drugs (P) Ltd. The undersigned is directed to refer to DGFT U.O.No. 01lB2l50l26BlAM-17/DES- 31179 dated lhe 417116 vide which application from M/s Optimus Drugs (P) Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Ledipasvir. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14.- lmport item AoroWyl)-2- ) heptane-2-carboxylic acid 1,1- er romo-9, 9-d ifl uoro-9 H-fluoren-2-yl )- -yl-5-azas piro Q.a) heptane-5- 1-dirrlethvl ethvl ester Diboron -tert butylphenyl phosphine) 2 S No 1 (lR,3S,4S)-3-(6- a―zabicyclo(22′ dirllethvl ethvl es 2 3 (6S)-6-(5¨ (7-bror lH― irnidazol-2-yl 望rbOXylic add l BiS(Pinacolato) 4 Dichloro Bis(dl pelledium(||) 0 86kg 1 25kg 00516k9 一―一―」 Under Secretary to the(3overnment oflndia PH:-23071162 粗讐肝° mmendedb l

Case No.:11/4/82-ALC4/2014 1Partv NamelBALAJI AMINES Meet No/Date:4/82‐

IStatus:Casel

:LIMITED ALC4/2014 Approved ‐ 03.072014 1 HQ Filc lRLA File
‐Lic No/Datei3110061053 1Defer Date: 1 101/82/050/00259/AM15/ 1:31/83/040/00136/AM14/ 13112013 1 ‐ Decision:in the light of written comments received from Department of Chemicals and Petrochemicals 1′ CCIS10El:ln lne llBnt ol vv子 :ttC:lしυ ::‖ ‖ピI:Lb:じしClVCu[:υ ‖ [L/C PCI[t‖ ]▼‖ t ViヽI:ヽ:'::‐ u,υ u,lЧ ,ヽヽ,v‐ …ヽ… ●,‐ ―・‐ 189も略」 :1111まもよ :♀:よl』〔憎 :流lよ:需亀肌 ;iぱl需1濡ポξ ;:li!1屋よ面 fy norms under Pan 471 Export Product Export Quantity S No lmport Product Quantity Allowed GAMMA BtlTYROLACTONE L kg 1 4 BllTANEI)1()L 1.16 kg GBL CATALYST 0 001 kg RA may take appropriate action as per the decision of Norms committee. 脚一

⌒ 玲 Aヽ41NES LIヽ41TED ZD.Uソ.ZU14 1 1 Lic No/Date:3110063437 1Defer Date: | HQ Filc RLA File :O1/82/050/00345/AM15/ :31/83/040/00217/AM14/ 09042014 1Decision : ln the light of written comments recelved from Department of Chemicals andl ‐Petrochemicals vide their U.O No.14010/122/2011-Ch.‖ dated 25.08.2014′ it was decided tol lratify norms under Para 4.7 of HBP vl as per detalls g市 en below or as applied by the nrm′ | whicheveris less: Export product Exp. Qtv SI No lmport items Qty. Allowed N‐ M FTH YI′ -2-I)YRR()I′ II)ONE l kg METHANOl′ 0 370 kg 2 AMMONIA ANHYDROUS 0.160 kg 3 l、4 BUTANED10L 1 044 kg 4 METHYIンAMINE CATALYST 0 00080 kg 5 GBL CATAI´ YST 0.00075 kg RA may take appropriate action as per the decision of Norms Committee. ey/ Mcet No/Date:8/82- IALC4/2014 Status: IALC4/2014 1Approved 25.09.2014 1

Case No.:28/5/82-

ALC4/2014 Parly Narne:BALAJI

署印0 〃ν:・多争 ' Government of lndia Ministry of Chemicals and Fertilizers Department of Chemicals and Petrochemicals

Subject: Advance Authorization application from M/s. Clean Science and Technology Pvt. Ltd.

(Advance Authorization No. 3110065713 dated 20.10.2015) ^ Ref: u.o. No. 01t82lo5ol1417tAM16/DES-|ll/1552 dated 14.1.2016 M/s. Clean Science and Technology Pvt. Ltd. have submitted present applications for the import of raw material against the export of GUAIACOL 99% PURITY' 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 GUAIACOL 99%PURITY l kg。 METHANEノANISOLE (PURI丁Y93%MAXIMUM) _ 1.287 kg … GEN PEROXIDE(60%) 0.687 kg 3.ACETONE 0.270 kg This issue with the approval of competent authority' Addl.industrial Adviser Tel.No.011-23381430 (A.K. AGAR\A/AL) | Deptt. of C&PC U.〇.No.14010ノ3/201芝―CH-11(V01.― |)dated 16.2.2016

F No.35011 17512016-Pl (Norms) Government of lndia Dated: July,2016 Office Memorandum Subject. - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case of M/s DSM Sinochem Phamaceuticals lndia Pvt. Ltd. The undersigned is directed to refer to DGFT U O.No. 011821501201/AM- 17IDES-3/270 dated lhe Bl7116 vide which application from M/s DSM Sinochem Pharmaceuticals lndia 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 Enzymatic route. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14.- S.No. lmport item Norms Recommended for 1kq Export 6-arYlinO penicillanic acid(6-APA) 0.55kq 2 Elcolase (Enzvme) 0 005kq 3 D(-) P-hydroxy phenyl glycine methyl ester 0.47Bkg 2 (Rajkumar) PH'.- 23071162 (Shri M V. Singh, FTDO),

VbE F. No.350 I 1 16812016-Pl (Norms) Government of lndia Dated: June, 2016 Office Memorandum Subject. - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case of M/s Fresenius Kabi Oncology Ltd. The undersigned is directed to refer to DGFT U O.No. 011821501171514M- 16/DES-3/1922 dated the 3013116 vide which application from M/s Fresenius Kabi Oncology Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of (1)Carboplatin injections 600m9/60m1, 450m9/45m1, 150m9/15m1, 50mg/5m1. This department has examined the matter and the following norms are furnished under para4.7 of Hand Book of Procedures (Vol.l) 2009-14'.- 2 (Rajkumar) PH'.- 23071162 S.No. lmport item For the Export of 'lNo. injection (Qty. in gms) 600mqノ60rnl 450mq/45m1 150mq/1 5rnl 50mq/5ml I Platinum (sponge powder) 045675 034256 01142 00381 2 1 ,1-cyclobutane dicarboxylic acid 0306 02295 00765 00255 3 Glass bottles Relevant, As per packing PolicY 4 Rubber stopper 5 Flip off Al-seals

F No.35011/116/2016-PI(Norms) Government oflndia Ministry of Chemical&Fertilizers Dated: July,2016 Office Memorandum 14 Case of M/s Fresenius Kabi Oncology Ltd. The undersigned is directed to refer to DGFT U.O No. 01182150178/AM-17/DES- 31117 dated the 2315116 vide which application from M/s Fresenius Kabi Oncology Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Oxaliplatin lnjections 200mg/40m1, 100mg/20m1, 100m9/50m1, 50mg/25m1, 50mg/10m1. 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 (Ralkumar) PH:-23071162 Directorate General of Foreign ttrade, Depanment Of Commerce, (Sh面MV・Singh,FTDO), Udyog Bhawan,New Delhi S No lmport item For Export of 1No. injection (Qty. in gms) 200mg/ 40ml 100mg/ 20rYll 100mg/ 50rYll 50mg/ 25ml 50mg/ 10ml Platinum (sponqe powder) 0.184 00919 00919 0046 0046 2 (lR,2R)― (― )-1,2-diamino― cvclohexane 01029 00515 00515 00257 00257 3 Glass vials Relevant, As per packing PolicY 4 Rubber stopper

a7 -"--qq7- F. No 3501117781201s-Pl (Norms) Government of lndia Dated: June, 2016 Office Memorandum 14 Case of M/s Sentiss Pharma (P) Ltd. The undersigned is directed to refer to DGFT U O.No. 01182150111731A.M- 16/DES-3/1285 dated the 16112115 vide which application from M/s Sentiss Pharma (P) Ltd. was sent to this Department for fixation of norms under paru'. 4.7 for the export of Broxinac Eye Drops, 0.09%, 1.7m1. 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 SNo lmport item Norms Recommended 1 Bromfenac Sod ium Hydrate 1 8475mc1/1 7rvll

of \5 2- F No.3501118251201s-Pl (Norms) Government of lndia Dated: 1 June, 2016 Office Memorandum 14 Case of M/s Ami Life Sciences Pvt. Ltd. The undersigned is directed to refer to DGFT U O No 0118215010013/AM- 17IDES-3/92 dated the 11 tll16 vide which application from M/s Ami Life Sciences Pvt Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of ftavoxate Hcl. This department has examined the matter and the following norms are turnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14.- 2 (Rajkumar) PH.- 23071162 (Shri M V. Singh, FTDO), S.No. lmport item Norms Recommended for 1kq Export 3-methvl-flavo ne-B-carboxyl ic acid 0.730ks

()'t \E* F. No.3501 1 11812016-Pl (Norms) Government of lndia Udyog Bhawan, Dated: New Delhi, June,2016 Office Memorandum Subject. - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s Sun Pharmaceuticals Industries Ltd. The undersigned is directed to referto DGFT U.O No. 01182150117161AM-161DES-3/1874 dated the 22t3116 vide which application from M/s Sun Pharmaceuticals lndustries Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Menopenem sterile and Meropenem injection 500mg. 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'.- (A) Meropenem Sterile (B) Norms Recommended for Meropenem Sterile つ乙 (Rajkumar) PH.- 23071162 (Shri M.V Singh, FTDO), S No lmport item Norms Recommended 1 Meropenem Stertle 627 . Smql 500mq i n jection S.No lmport item Norms Recommended for 1kg Export 1 2-dimethylamino-4-mercapto Pnz Proline '1 .133kq つ４ Acetone 11 92kq 3 Activated carbon 0.1 '14kq 4 Dimethvl formamide 5 09kq tr lsopropvl alcohol 3.58kq 6 Methylene chloride 0 79kq 7 Palladium sponqe 3 856qm 8 p-nitrobenzyl ( I R, 5R,6S)-6-[( 1 R)-1 -hydroxy ethyl]-2-[(d iphenyl ohosohono)oxvl- 1 -methvl carbapen-2-EM-3-carboxylate 1.B0Bkg

つ４ rt 1.03k9 PH1 23071162 (Shri M.V. Sinsh, FTDO). Udyog Bhawan, New Delhr F No 3501II13312016-Pl (Norms) Government of lndia Dated IBJuly 2016 Office Memorandum Case of M/s S.M. Herbals (P) Ltd. The undersigned is directed to refer to DGFT U.O.No. 01l12l50l196lAM-17/DES- 3/194 dated the 417116 vide which application from M/s S.M. Herbals (P) Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of 10 Deacetyl Baccatin-lll HPLC Purity Not Less Than 98.5%. 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:- No rms Recommended for 1k Xelones rn carbonyl Group-10 Deacetyl Baccaln l‖ HPLC Purttv Not More Than 95 5%

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Case No.:205/13/82-

Al」C4/2014 HQ「ile :01/82/050/01208/AM15/ Party Nanle:IPcA LABORATORIES LIMITED νleet No/Datei3/82- ALC4/2015 20_052015 Sta tus: Approved RLA File i03/94/040/00402/AM15/ Lic.No/Date:0310787783 07082014 Decis10n:丁hc committee decided to ratify the norms based on the reCOmmendatiOn Of Department of pharmaceuticals vide o.M.No . 3s01,1./42/2015-pl (Nor:ms) Dated 29.0:5 2015 as 100 per detalis given beloMノ Or aS apphed by the firm whicheverisless:― Export product Qty Irrport iterns Qty KゴKq I,!orantel Cilrate しヽ 3-lVlethyl Thiophene 0330 Acetorritrile 0 !80 Il!n1e!1, I fornranr ide 0270 Citric Acid 0640 Iso propyl Alcohol 0225

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ヽ F. No.350 1 1 11341201 6-Pl (Norms) Government of lndia Dated: l5.July, 2016 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures

(Vol.l) 2009-14 Case of M/s Saurav Chemicals Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501211/AM-17/DES-3/191 dated lhe 417116 vide which application from M/s Saurav Chemicals Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Dexketoprofen Trometamol. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14.- 2. PH'- 23071162 SNo lmport item Norms Recommended for 1kq Export Ketoprofen rcAls 2 N-octyl-D-Glucamine 0.36kq 3 Tromethamine 0.36kq

s7 ---'qg?- F. No.350 1 1 11201201 6-Pl (Norms) Government of lndia Dated: July, 2016 Office Memorandum 14 Case of M/s Morepen Labs Ltd. The undersigned is directed to referto DGFT U O No. 01182150179/AM-17/DES- 31113 dated the 2315116 vide which application from M/s Morepen Labs Ltd. was sent to this Department for fixation of norms under paru'. 4.7 for the export of Montelukast Sodium. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14.- 2 (Rajkumar) PH.- 23071162 SNo lmport item Norms Recommended for 1kq Export ( S ) - ( E ) -2 -t 2-13 -12- (7 -c h I o ro-2 -q u i n o I i n y I ) -eth e n y I phenvll-3-hydroxy propyll phenyll-2-propanol 1.24kg 2 Methanol 2 325ks 3 N, N-DiisopropVlethylamine 0 30kq 4 Tetrahydrofuran 3.1 5ks 5 Acetonitrile 2 95kq 6 2-[ 1 -(mercaptornethyl)cvclopropyllacetic acid 0.40ks

5+ gbo F No.35011117912016-Pl (Norms) Government of lndia Dated: lfJuly, 2016 Office Memorandum Case of M/s Glenmark Pharmaceuticals Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501336/AM-17/DES- 31260 dated the Bl7116 vic.le which application from M/s Glenmark Pharmaceuticals Ltd. was sent to this Department for fixation of norms under para. 4.7 for the export of Cilostazol. This department has examined the matter and the following norms are furnished under para4.7 of Hand Book of Procedures (Vol.l) 2009-14.- lmport item Recommended I*l ort s (4-l!lprqqqt_yl) t "v_s_lq! 0 BB[g_ l -l 6-hyd tgy-3,4-d i tr vtp lH inolin-2-one 0.59k9 _--l I This issues with the approval of competent authority PH!-23071162 (Shri MV Singh,FTDO), Norms

´フ 5% ヘ F. No.3501 1143512013-PI (Norms) Government of India UdyOg Bhawan, 1lth September,2013 Offlce Memorandum SutteCt:― F破ation of nolllls under para 4.7 of Hand Book Of Procedures(Vol・1)2009-14 Case of N1/s.Cadila Healthcare Ltd. The undersigned is directed to refer to DGFT U.OoNo.01/82/50/1418/AM13/DES-3/64 dated the 10/04/13 vide which representation frorn N1/s.Cadila Healthcare Ltd was sent to this Department for flxation of norl■s under para:4.7 for the export of Silnvastatin Tablets.This department has exanlined the matter and the following norms are furrlished under para 4.7 of Hand Book of Procedurcs(Vol.1)2009-14:― 2. This issues with the approval of Director (Cost)' (Raj Kumar) Under Secretary to the Government of India PI-Norms (Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi' New Delhi,the S.No. Import Item For Export of lNo.Tablets Qty in mg _ Dmg 10mg 20mg 40mg 80mg 1 Simvastatin 5.10 10.20 20.40 40。80 81.60 2. Lactose anhydrous 39.55 77.42 154.84 309.68 619.36 3. Citric acid, anhYdrous 0.75 1.50 3.00 6.00 12.00 4. Magnesium stearate 0.50 1.00 2.00 4.00 8.00 5. Dehydrated alcohol 0.85 1.70 3.40 6.80 13.60 6. Bottles and caPs Relevant,As pQr paCking policy. __

ゞ1,ハム"5だ〕こ焉∬よuMrED f irm, whichever is less: #---' t"rthedecisionof 1,.p. r*f, iake furiher appropriate actton as 1 Meet No/Date:3/82‐ ALC4/2014 080512014 Status:Case APProved RLA F-ile Lic'NolDate:0i 10769229 Det-er Date: li?il','ito,ro I 57/AM I -ii :0 j/e4l040/00e76/AN4l4/ 05 '02'2014 3/82 dated 06'03'2013' it was Decision lln the light of earlier decision taken in meeting no' 2 decided to ratify riorms under para 4.-7 of HBp v 1 as per details given below or as applied by the 326 lmport Product QuantitV Allowed Export ProduCt Export Quantity S No 1.5384 kg l kg 1 3-Amino PYrazole Carboxamide HemisulPhate Alloourinol 2 Formamide 1 50 kg Norms Committee. ハ

(lasc No.:37/14/82-ALC4/2012 Palty Nanlc:IPCA ヽlcct No/Date:28/82‐ Status:Case Approved LABORATORIES LIヽ41TED ALC4/2012 10012013 HQ「ilc F RLA Filc 'Lic No/Date:0310696330 Defer Date: ,01/82/050/00414/Aヽ413/ ■03/94/040/00143/ANl13/ 128052012 Decition l ih tiさ lLit 6fwrittさncも11ふさ Aiζ 穐 ``i↓ きさfr8ふDcpariふさ nt oF Iおa111:`きitical:↓iきさtheir 6M｀も 350H/578/2012-PI(NOrnls)dated 27 12.2012、 it was decided to rati～ nOrnls undcr Para 4 7 of HBP vl as per cletails qiven belorv or as icd bv thc flrrn, u,hichever is less: L',xport Procluct Export Qtl SI No Inrport items Qty. allorved GIinrc'piride l k3 l 4-[ 2-( 3-Eth,r:l-:l- N'l ethl | -2- Carbonyl-Pyrrolidonylarlino )-Ethyl l-Phen_vl SulforrrideI i\4PR-lI I 0 80 kg Trans-4-Methvl Cvclohcxvlanlinc 0 39 kg 4-( Dimethl"l anrino )Pvlicline 0 100 kg Eth、l Chloro Fo「lnatc 0.3761<g N/1ethvlenc Di Chloridc 0 93 kg Acetone 223k_4 S.B. Toluene 1 84 kg R..\ nral take appropriate actiolt as pel the decisiorr of Norms Cornmittee 脂 ?/, l-/", S ,L/

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