IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2016-02-16

DGFT Committee Minutes

Document text

Office of Directorate General of Foreign Trade
New Delhi -110011

Para 4.7 Decision

Meeting No. 18/82/2015 of 2015-16, to consider the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products and falling under Chapter 29 and 30, was scheduled for 10.02.2016 but actually held on 16.02.2016. The meeting was held under the Chairmanship of Dr. S.K. Bansal, Jt. DGFT in Room No.107, Udyog Bhawan, New Delhi.

Following members were present:-

Shri A.K. Aggarwal, Addl. Indl. Adviser, D/o C&PC Shashtri Bhavan, New Delhi Shri D.N.Mathur, Consultant, D/o Pharmaceuticals. Shri Nirmal Kumar, Dy. DGFT, Directorate General of Foreign Trade Shri Mahendra Vikram Singh, FTDO, Directorate General of Foreign Trade

The committee went through the minutes of earlier NC-III meeting No. 17/82 was scheduled for 27.01.2016 but actually held on 01.02.2016 and approved the same.

Note: In certain cases the decision of the Norms Committee refers to the Recommendations/ Observations / Deficiencies received from the concerned Technical authority in the same case or a different case of another firm with the same product. A scanned copy of such document is placed at the end of the Minutes. In some cases, the scanned copy uploaded may be unsigned.
In both these instances, the scanned copy uploaded is to be accepted MEETING NUMBER
: 18/82-ALC4/2015 MEETING DATE : 10.02.2016

Case No.:46/13/82-ALC4/2015 Party Name:DEEPAK NITRITE

LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01009/AM16/
RLA File :34/24/040/00241/AM13/
Lic.No/Date:3410036142 15.02.2013 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/36/2012-Ch-II dated 8.12.2015, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No.:173/14/82-

ALC4/2015
Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01309/AM16/
RLA File :03/95/040/00881/AM10/
Lic.No/Date:0310726567 04.03.2013 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comments of DC&PC(Chemicals)

Case No.:113/14/82-

ALC4/2013
Party Name:PARAMOUNT AROMACHEM PVT.LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00698/AM14/
RLA File :05/24/040/00488/AM13/
Lic.No/Date:0510350269 26.03.2013 Defer Date:09.03.2016 Decision : The Committee decided to defer the case for want of comments of DC&PC(Chemicals).

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

Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00454/AM15/
RLA File :03/95/040/01043/AM14/
Lic.No/Date:0310776594 01.04.2014 Defer Date:09.03.2016 DC&PC(Chemicals)

Case No.:54/5/82-ALC4/2014 Party Name:NEW ALLIANCE

DYE-CHEM PVT. LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/00371/AM15/
RLA File :03/95/040/00077/AM15/
Lic.No/Date:0310780621 05.05.2014 Defer Date: C&PC forwarded vide U.O.No.14010/13/2012-Ch-II dated 05.10.2015, uploaded along

Case No.:238/6/82-

ALC4/2014
Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00640/AM15/
RLA File :17/24/040/00008/AM15/
Lic.No/Date:1710005810 09.05.2014 Defer Date:09.03.2016 DC&PC(Chemicals)

Case No.:121/14/82-

ALC4/2015
Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01257/AM16/
RLA File :17/24/040/00006/AM15/
Lic.No/Date:1710005809 09.05.2014 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comments of DC&PC

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

LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00490/AM15/
RLA File :03/95/040/00033/AM15/
Lic.No/Date:0310782129 20.05.2014 Defer Date:09.03.2016 DC&PC(Chemicals)

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

INDUSTRIES Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00309/AM15/
RLA File :03/95/040/00190/AM15/
Lic.No/Date:0310785305 13.06.2014 Defer Date:09.03.2016 DC&PC(Chemicals)

Case No.:164/6/82-ALC4/2014 Party Name:VDH CHEM

TECH PVT. LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/00566/AM15/
RLA File :05/24/040/00085/AM15/
Lic.No/Date:0510388792 18.06.2014 Defer Date: C&PC forwarded vide U.O.No.14010/58/2010-Ch-II dated 16.02.2016, uploaded along

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

PHARMA LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00317/AM15/
RLA File :09/24/040/00175/AM15/
Lic.No/Date:0910060550 27.06.2014 Defer Date:09.03.2016 Decision :The Committee noted that copy of application has already been called for firm RA / Firm and the same is awaited. The committee decided to remind RA/firm to submit the same and deferred the case.

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

& RESINS PVT. LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00870/AM15/
RLA File :03/94/040/00755/AM14/
Lic.No/Date:0310786181 30.06.2014 Defer Date:09.03.2016 DC&PC(Chemicals)

Case No.:370/5/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00510/AM16/
RLA File :09/24/040/00193/AM15/
Lic.No/Date:0910060634 09.07.2014 Defer Date:09.03.2016 Decision :The Committee noted that information called for from the firm is awaited. The Committee accordingly decided await the reply and deferred the case.

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

Name:METROPOLITAN EXIMCHEM LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:0310787073 Defer

:01/82/050/00876/AM15/
:03/95/040/00337/AM15/
18.07.2014 Date:09.03.2016 DC&PC(Chemicals)

Case No.:396/5/82-

ALC4/2015
Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00536/AM16/
RLA File :17/24/040/00047/AM15/
Lic.No/Date:1710005887 24.07.2014 Defer Date:09.03.2016 DC&PC(Chemicals).

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

INDUSTRIES Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00410/AM15/
RLA File :03/95/040/00331/AM15/
Lic.No/Date:0310787382 28.07.2014 Defer Date:09.03.2016 DC&PC(Chemicals).

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

LABORATORIES, Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00855/AM15/
RLA File :03/94/040/00171/AM15/
Lic.No/Date:0310787536 01.08.2014 Defer Date:09.03.2016 Decision :Copy of application has been called for from the firm/RA and same is awaited..

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

SPECIALITY CHEMICALS LIMITED, Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00846/AM15/
RLA File :04/24/040/00106/AM15/
Lic.No/Date:0410159125 01.08.2014 Defer Date:09.03.2016 DC&PC(Chemicals).

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

ORGANICS PVT. LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00828/AM15/
RLA File :03/94/040/00074/AM15/
Lic.No/Date:0310787610 04.08.2014 Defer Date:09.03.2016 DC&PC(Chemicals)

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

SHIVSHANKAR DRUGS & PHARMACEUTICALS P. LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:0310788055 Defer

:01/82/050/01138/AM16/
:03/95/040/00425/AM15/
14.08.2014 Date:09.03.2016 DC&PC(Chemicals)

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

PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00188/AM16/
RLA File :09/24/040/00260/AM15/
Lic.No/Date:0910060860 18.08.2014 Defer Date:09.03.2016 Decision :The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.No.35011/570/2015-PI(Norms) dated December 2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

Case No.:215/13/82-

ALC4/2014
Party Name:GOLD STAR CHEMICALS PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01218/AM15/
RLA File :03/94/040/00358/AM15/
Lic.No/Date:0310788338 25.08.2014 Defer Date:09.03.2016

Case No.:264/13/82-

ALC4/2014
Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01267/AM15/
RLA File :03/94/040/00405/AM15/
Lic.No/Date:0310788397 26.08.2014 Defer Date:09.03.2016 Decision : The Committee decided to defer the case for want of comments of DC&PC.

Case No.:255/13/82-

ALC4/2014
Party Name:THE DHARAMSI MORARJI CHEMICAL CO LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01258/AM15/
RLA File :03/95/040/00431/AM15/
Lic.No/Date:0310788373 26.08.2014 Defer Date:09.03.2016 Decision :The Committee based on the written comments forwarded by the D/o C&PC vide letter No.14010/6/2015-Ch-II dated 10.04.2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

Case No.:377/5/82-

ALC4/2015
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00517/AM16/
RLA File :03/94/040/00493/AM15/
Lic.No/Date:0310788472 27.08.2014 Defer Date:09.03.2016 Decision : The Committee decided to defer the case for want of comments of DoP.

Case No.:224/13/82-

ALC4/2014
Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred

HQ File :01/82/050/01227/AM15/
RLA File :03/94/040/00391/AM15/
Lic.No/Date:0310788515 28.08.2014 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comments of DCPC

Case No.:225/13/82-

ALC4/2014
Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01228/AM15/
RLA File :03/94/040/00397/AM15/
Lic.No/Date:0310788514 28.08.2014 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comments of DCPC

Case No.:262/13/82-

ALC4/2014
Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01265/AM15/
RLA File :03/94/040/00971/AM14/
Lic.No/Date:0310788560 01.09.2014 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comments of DCPC

Case No.:263/13/82-

ALC4/2014
Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01266/AM15/
RLA File :03/94/040/00962/AM14/
Lic.No/Date:0310788558 01.09.2014 Defer Date:09.03.2016 vide letter No.14010/55/2012-Ch-II dated 19.03.2015, uploaded along with these minutes

Case No.:223/13/82-

ALC4/2014
Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01226/AM15/
RLA File :03/94/040/00508/AM15/
Lic.No/Date:0310788647 02.09.2014 Defer Date:09.03.2016 Decision : The Committee decided to defer the case for want of comments of DC&PC.

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

INTERMEDIATES P LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00647/AM15/
RLA File :04/24/040/00139/AM15/
Lic.No/Date:0410159328 02.09.2014 Defer Date:09.03.2016 Decision : The Committee decided to defer the case for want of comments of DC&PC.

Case No.:400/5/82-

ALC4/2015
Party Name:YASH RASAYAN & CHEMICALS Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00540/AM16/
RLA File :34/24/040/00120/AM15/
Lic.No/Date:3410040554 15.09.2014 Defer Date:09.03.2016 Decision : The Committee decided to defer the case for want of comments of DC&PC.

Case No.:12/15/82-

ALC4/2014
Party Name:JINDAL DRUGS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status: Case Deferred HQ File :01/82/050/01299/AM15/
RLA File :03/94/040/00460/AM15/
Lic.No/Date:0310789265 16.09.2014 Defer Date:09.03.2016 Decision : The Committee decided to defer the case for want of comments of DC&PC.

Case No.:380/5/82-

ALC4/2015
Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00520/AM16/
RLA File :22/24/040/00054/AM15/
Lic.No/Date:2210015086 16.09.2014 Defer Date:09.03.2016 Decision :Information called for from the firm is awaited. The Committee accordingly, decided to await the reply and deferred the case.

Case No.:59/13/82-

ALC4/2014
Party Name:HELLO PAINTS (P) LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01062/AM15/
RLA File :05/23/040/00276/AM15/
Lic.No/Date:0510391245 19.09.2014 Defer Date:09.03.2016 vide letter No.14010/72/2014-Ch-II dated 27.01.2016, uploaded along with these minutes

Case No.:49/5/82-ALC4/2015 Party Name:VISION DRUGS

PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/00189/AM16/
RLA File :09/24/040/00336/AM15/
Lic.No/Date:0910061013 23.09.2014 Defer Date: Decision :The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.No.35011/570/2015-PI(Norms) dated December dated 2015, uploaded along with these minutes decided to call for technical information from the firm

Case No.:372/5/82-

ALC4/2015
Party Name:DR J PHARMACHEM (INDIA)(PROP.ADITYA PRAMOD JOGDEO) Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00512/AM16/
RLA File :31/83/040/00154/AM15/
Lic.No/Date:3110064948 08.10.2014 Defer Date:09.03.2016 Decision :: DOP has informed that export product pertains to Department of Chemicals and Petrochemicals. Accordingly, copy of application has been sent to DCPC.

Case No.:29/13/82-

ALC4/2014
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:0510391490 Defer

:01/82/050/01032/AM15/
:05/23/040/00268/AM15/
08.10.2014 Date:09.03.2016 Decision :The Committee decided to defer the case for want of comments of DCPC

Case No.:124/13/82-

ALC4/2014
Party Name:PANACEA BIOTEC LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01127/AM15/
RLA File :05/24/040/00319/AM15/
Lic.No/Date:0510391623 17.10.2014 Defer Date:09.03.2016 Decision : The Committee based on the written comments forwarded by the DBT vide letter No.BT/IL/05/316/2010 dated 29.02.2016, uploaded along with these minutes

Case No.:393/5/82-

ALC4/2015
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00533/AM16/
RLA File :09/24/040/00387/AM15/
Lic.No/Date:0910061210 11.11.2014 Defer Date:09.03.2016 Decision : The Committee based on the written comments forwarded by the DBT vide letter No.35011/484/2015-PI (Norms) Dated November 2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

Case No.:198/5/82-

ALC4/2015
Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00338/AM16/
RLA File :04/24/040/00205/AM15/
Lic.No/Date:0410159704 11.11.2014 Defer Date:09.03.2016 Decision : The Committee decided to defer the case for want of comment from DoP.

Case No.:72/18/82-

ALC4/2014
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01438/AM15/
RLA File :03/94/040/00773/AM15/
Lic.No/Date:0310791044 13.11.2014 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comment from DoP.

Case No.:15/18/82-ALC4/2015 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status: Approved HQ File :01/82/050/01480/AM16/
RLA File :03/95/040/00666/AM15/
Lic.No/Date:0310791043 13.11.2014 Defer Date: C&PC forwarded vide U.O.No.14010/95/2011-Ch-II dated 23.11.2015, uploaded along

44 Case No.:65/15/82- ALC4/2014
Party Name:ABEERS PHARMACEUTICALS PVT Meet No/Date:18/82- ALC4/2015 Status:Case Deferred

LTD 10.02.2016 HQ File :01/82/050/01352/AM15/
RLA File :05/23/040/00360/AM15/
Lic.No/Date:0510392011 14.11.2014 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comment from AYUSH.

Case No.:126/8/82-

ALC4/2015
Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00922/AM16/
RLA File :03/94/040/00710/AM15/
Lic.No/Date:0310791177 18.11.2014 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comment from DCPC

Case No.:52/15/82-

ALC4/2014
Party Name:MYLAN Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01339/AM15/
RLA File :09/24/040/00408/AM15/
Lic.No/Date:0910061280 20.11.2014 Defer Date:09.03.2016 Decision :The Committee noted that information called for from the firm in NC meeting No.09 dated 30.09.2015 is awaited. The Committee accordingly decided to defer the case.

Case No.:355/5/82-

ALC4/2015
Party Name:GRANULES INDIA LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00495/AM16/
RLA File :09/24/040/00433/AM15/
Lic.No/Date:0910061297 25.11.2014 Defer Date:09.03.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.No.35011/669/2012-PI(Norms) dated 12.03.2013, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

Case No.:94/13/82-

ALC4/2014
Party Name:HETERO DRUGS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01097/AM15/
RLA File :09/24/040/00469/AM15/
Lic.No/Date:0910061300 25.11.2014 Defer Date:09.03.2016 Decision : The Committee noted that information called for from the firm in NC meeting No.12 dated 18.11.2015 is awaited. The Committee accordingly decided to defer the case

Case No.:43/18/82-

ALC4/2014
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01409/AM15/
RLA File :03/95/040/00701/AM15/
Lic.No/Date:0310791419 26.11.2014 Defer Date:09.03.2016

50 Case No.:126/5/82- ALC4/2015
Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:18/82- ALC4/2015 Status:Case Deferred

10.02.2016 HQ File :01/82/050/00266/AM16/
RLA File :22/24/040/00074/AM15/
Lic.No/Date:2210015136 28.11.2014 Defer Date:09.03.2016 No.14 dated 16.12.2015 is awaited. The Committee accordingly decided to defer the case

Case No.:362/5/82-

ALC4/2015
Party Name:KLJ PLASTICIZERS LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00502/AM16/
RLA File :05/23/040/00377/AM15/
Lic.No/Date:0510392211 28.11.2014 Defer Date:09.03.2016

Case No.:154/5/82-

ALC4/2015
Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00294/AM16/
RLA File :03/95/040/00740/AM15/
Lic.No/Date:0310791735 05.12.2014 Defer Date:09.03.2016 No.14 dated 16.12.2015 is awaited. The Committee accordingly decided to defer the case

Case No.:139/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00279/AM16/
RLA File :03/94/040/00872/AM15/
Lic.No/Date:0310791890 10.12.2014 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comment from DoP.

Case No.:145/5/82-

ALC4/2015
Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00285/AM16/
RLA File :03/94/040/00877/AM15/
Lic.No/Date:0310792112 17.12.2014 Defer Date:09.03.2016

Case No.:130/5/82-ALC4/2015 Party Name:NAVIN

FLUORINE INTERNATIONAL LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/00270/AM16/
RLA File :03/95/040/00652/AM15/
Lic.No/Date:0310792103 17.12.2014 Defer Date: C&PC forwarded vide U.O.No.14010/92/2011-Ch-II dated 08.02.2016 , uploaded along

56 Case No.:127/5/82- Party Name:EMAMI Meet No/Date:18/82- Status:Case

ALC4/2015
LIMITED, ALC4/2015 10.02.2016 Deferred HQ File :01/82/050/00267/AM16/
RLA File :02/24/040/00183/AM15/
Lic.No/Date:0210205355 18.12.2014 Defer Date:09.03.2016 Decision : The Committee decided to defer the case for want of comment from DoP.

Case No.:133/5/82-

ALC4/2015
Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00273/AM16/
RLA File :03/94/040/00883/AM15/
Lic.No/Date:0310792178 19.12.2014 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comment from DoP

Case No.:224/5/82-

ALC4/2015
Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00364/AM16/
RLA File :09/24/040/00531/AM15/
Lic.No/Date:0910061427 22.12.2014 Defer Date:09.03.2016 No.12/82 dated 18.11.2015 is awaited. The Committee accordingly decided await the reply and deferred the case.

Case No.:136/5/82-

ALC4/2015
Party Name:AVIGNON EXIM PVT.LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00276/AM16/
RLA File :03/94/040/00843/AM15/
Lic.No/Date:0310792314 23.12.2014 Defer Date:09.03.2016

Case No.:96/5/82-ALC4/2015 Party Name:J.B. CHEMICALS

& PHARMACEUTICALS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00236/AM16/
RLA File :03/94/040/00912/AM15/
Lic.No/Date:0310792310 23.12.2014 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comment from DoP

Case No.:221/5/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00361/AM16/
RLA File :09/24/040/00537/AM15/
Lic.No/Date:0910061442 23.12.2014 Defer Date:09.03.2016

Case No.:114/5/82-

ALC4/2015
Party Name:NATIONAL TUBE INDUSTRIES, Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred

HQ File :01/82/050/00254/AM16/
RLA File :03/95/040/00756/AM15/
Lic.No/Date:0310792363 24.12.2014 Defer Date:09.03.2016 Decision : Requisite information has been received and sent to DCPC. The Committee accordingly, decided to defer the case for want of comment from DCPC

Case No.:218/5/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00358/AM16/
RLA File :09/24/040/00552/AM15/
Lic.No/Date:0910061462 29.12.2014 Defer Date:09.03.2016

Case No.:138/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00278/AM16/
RLA File :03/94/040/00920/AM15/
Lic.No/Date:0310792544 01.01.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comment from DoP

Case No.:84/5/82-ALC4/2015 Party Name:SHIVA

PHARMACHEM LTD, Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00224/AM16/
RLA File :34/24/040/00259/AM15/
Lic.No/Date:3410040852 01.01.2015 Defer Date:09.03.2016

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

AROMACHEM PVT.LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00633/AM16/
RLA File :05/24/040/00428/AM15/
Lic.No/Date:0510392678 05.01.2015 Defer Date:09.03.2016

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

SCIENCES LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00185/AM16/
RLA File :09/24/040/00558/AM15/
Lic.No/Date:0910061483 05.01.2015 Defer Date:09.03.2016 Decision :Copy of application has been sent to DoP on 18.2.2016. The Committee decided to defer the case for want of comment from DoP.

Case No.:102/5/82-

ALC4/2015
Party Name:ALTA LABORATORIES LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00242/AM16/
RLA File :03/94/040/00836/AM15/
Lic.No/Date:0310792635 07.01.2015 Defer Date:09.03.2016

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

DYE-CHEM PVT. LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00214/AM16/
RLA File :03/95/040/00833/AM15/
Lic.No/Date:0310792647 07.01.2015 Defer Date:09.03.2016

Case No.:149/5/82-

ALC4/2015
Party Name:ALCHEMIE LABORATORIES Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00289/AM16/
RLA File :03/94/040/00813/AM15/
Lic.No/Date:0310792673 08.01.2015 Defer Date:09.03.2016

Case No.:122/5/82-ALC4/2015 Party Name:NEW ALLIANCE

DYE-CHEM PVT. LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/00262/AM16/
RLA File :03/95/040/00682/AM15/
Lic.No/Date:0310792689 08.01.2015 Defer Date: C&PC forwarded vide U.O.No.14010/13/2012-Ch-II dated 05.10.2015 , uploaded along

Case No.:121/5/82-

ALC4/2015
Party Name:UNIJULES LIFE SCIENCES LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00261/AM16/
RLA File :03/95/040/00835/AM15/
Lic.No/Date:0310792685 08.01.2015 Defer Date:09.03.2016 No. 14 dated 16.12.2015 is awaited. The Committee accordingly decided await the

Case No.:219/5/82-

ALC4/2015
Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00359/AM16/
RLA File :09/24/040/00549/AM15/
Lic.No/Date:0910061517 09.01.2015 Defer Date:09.03.2016

Case No.:239/5/82-

ALC4/2015
Party Name:MYLAN Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00379/AM16/
RLA File :09/24/040/00555/AM15/
Lic.No/Date:0910061520 09.01.2015 Defer Date:09.03.2016

No. 12 dated 18.11.2015 is awaited. The Committee accordingly decided await the reply

Case No.:141/5/82-

ALC4/2015
Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00281/AM16/
RLA File :03/94/040/00746/AM15/
Lic.No/Date:0310792870 13.01.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comments of DoP

Case No.:119/5/82-

ALC4/2015
Party Name:SHALINA Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00259/AM16/
RLA File :03/95/040/00843/AM15/
Lic.No/Date:0310792869 13.01.2015 Defer Date:09.03.2016 No. 14 dated 16.12.2015 is awaited. The Committee accordingly decided await the reply

Case No.:59/5/82-ALC4/2015 Party Name:ANTHEA

AROMATICS PVT.LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00199/AM16/
RLA File :03/94/040/00793/AM15/
Lic.No/Date:0310792911 14.01.2015 Defer Date:09.03.2016 vide letter No.14010/55/2012-Ch-II dated 28.10.2015, uploaded along with these minutes

Case No.:243/5/82-

ALC4/2015
Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00383/AM16/
RLA File :09/24/040/00589/AM15/
Lic.No/Date:0910061530 14.01.2015 Defer Date:09.03.2016 No. 12dated 18.11.2015 is awaited. The Committee accordingly decided await the reply

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

PHARMACEUTICALS PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00228/AM16/
RLA File :05/23/040/00486/AM15/
Lic.No/Date:0510392949 21.01.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comments of AYUSH.

Case No.:1/2/82-ALC4/2015

Party Name:SHREE BANKEY BEHARI LAL BOARD MILLS Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/00016/AM16/
RLA File :05/24/040/00453/AM15/
Lic.No/Date:0510392953 21.01.2015 Defer Date: C&PC forwarded vide U.O.No.14010/28/2012-Ch-II dated 30.9.2015, uploaded along

Case No.:269/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00409/AM16/
RLA File :03/94/040/01006/AM15/
Lic.No/Date:0310793301 27.01.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comment from DoP

Case No.:85/5/82-ALC4/2015 Party Name:V.D.H.

ORGANICS PVT. LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/00225/AM16/
RLA File :05/24/040/00500/AM15/
Lic.No/Date:0510392989 27.01.2015 Defer Date: C&PC forwarded vide U.O.No.14010/58/2015 dated 16.2.2016, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No.:163/5/82-

ALC4/2015
Party Name:RANBAXY LABORATORIES LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00303/AM16/
RLA File :05/24/040/00503/AM15/
Lic.No/Date:0510393026 29.01.2015 Defer Date:09.03.2016 No. 12 dated 18.11.2015 is awaited. The Committee accordingly decided await the reply

Case No.:138/8/82-

ALC4/2015
Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00934/AM16/
RLA File :03/94/040/01099/AM14/
Lic.No/Date:0310793426 30.01.2015 Defer Date:09.03.2016 Decision :The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.No.35011/653/2015-PI(Norms) dated 01.02.2016, uploaded along with these minutes decided to call for technical information from the firm and

deferred the case.

Case No.:275/5/82-

ALC4/2015
Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00415/AM16/
RLA File :03/94/040/00930/AM15/
Lic.No/Date:0310793539 03.02.2015 Defer Date:09.03.2016

Case No.:284/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00424/AM16/
RLA File :03/94/040/01053/AM15/
Lic.No/Date:0310793620 05.02.2015 Defer Date:09.03.2016 Decision :It was decided to defer the case for want of comments of D/o Pharmaceuticals.

Case No.:169/5/82-

ALC4/2015
Party Name:TIDE INDUSTRIES Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00309/AM16/
RLA File :34/24/040/00290/AM15/
Lic.No/Date:3410040927 05.02.2015 Defer Date:09.03.2016 No.14 dated 16.12.2015 is awaited. The Committee accordingly decided await the reply and deferred the case

Case No.:344/5/82-ALC4/2015 Party Name:NAVIN

FLUORINE INTERNATIONAL LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/00484/AM16/
RLA File :03/95/040/00445/AM15/
Lic.No/Date:0310793706 09.02.2015 Defer Date: C&PC forwarded vide U.O.No.14010/92/2011-Ch-II dated 8.02.2016 uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No.:290/5/82-

ALC4/2015
Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00430/AM16/
RLA File :22/24/040/00098/AM15/
Lic.No/Date:2210015190 10.02.2015 Defer Date:09.03.2016 No.14 dated 16.12.2015 is awaited. The Committee accordingly decided await the reply and deferred the case

90 Case No.:348/5/82-ALC4/2015 Party Name:NEW ALLIANCE Meet No/Date:18/82- Status:Case

DYE-CHEM PVT. LTD., ALC4/2015 10.02.2016 Approved HQ File :01/82/050/00488/AM16/
RLA File :03/95/040/00895/AM15/
Lic.No/Date:0310793791 11.02.2015 Defer Date: C&PC forwarded vide U.O.No.14010/13/2012-Ch-II dated 05.10.2015 uploaded along

Case No.:333/5/82-

ALC4/2015
Party Name:MEHTA API PVT LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00473/AM16/
RLA File :03/95/040/00903/AM15/
Lic.No/Date:0310793861 12.02.2015 Defer Date:09.03.2016 Decision : It was decided to defer the case for want of comments of DOP.

Case No.:283/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00423/AM16/
RLA File :03/94/040/01084/AM15/
Lic.No/Date:0310793953 18.02.2015 Defer Date:09.03.2016 Decision :The Committee noted that information called for from the firm is awaited. The Committee accordingly decided await the reply and deferred the case.

Case No.:279/5/82-

ALC4/2015
Party Name:CROWN CHEMICALS PVT.LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00419/AM16/
RLA File :03/94/040/01088/AM15/
Lic.No/Date:0310793983 19.02.2015 Defer Date:09.03.2016 Decision :It was decided to defer the case for want of comments of D/o C&PC (Chemicals)

Case No.:288/5/82-

ALC4/2015
Party Name:CROWN CHEMICALS PVT.LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00428/AM16/
RLA File :03/94/040/01089/AM15/
Lic.No/Date:0310793982 19.02.2015 Defer Date:09.03.2016 Decision :It was decided to defer the case for want of comments of D/o C&PC (Chemicals).

Case No.:332/5/82-

ALC4/2015
Party Name:O C SPECIALITIES PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00472/AM16/
RLA File :03/95/040/00991/AM15/
Lic.No/Date:0310794000 19.02.2015 Defer Date:09.03.2016 vide letter No.14010/108/2012-Ch-II dated 11.02.2016, uploaded along with these minutes

Case No.:335/5/82-

ALC4/2015
Party Name:PRIVI ORGANICS LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00475/AM16/
RLA File :03/95/040/00978/AM15/
Lic.No/Date:0310794038 20.02.2015 Defer Date:09.03.2016

Case No.:280/5/82-

ALC4/2015
Party Name:FERMENTA BIOTECH LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00420/AM16/
RLA File :03/94/040/01110/AM15/
Lic.No/Date:0310794101 24.02.2015 Defer Date:09.03.2016 No. 14 dated 16.12.2015 is awaited. The Committee accordingly decided await the

Case No.:232/5/82-

ALC4/2015
Party Name:RANBAXY LABORATORIES LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00372/AM16/
RLA File :05/24/040/00560/AM15/
Lic.No/Date:0510393348 24.02.2015 Defer Date:09.03.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.No.35011/378/2015-PI(Norms) dated December 2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

Case No.:334/5/82-

ALC4/2015
Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00474/AM16/
RLA File :03/95/040/00862/AM15/
Lic.No/Date:0310794100 24.02.2015 Defer Date:09.03.2016 Decision :It was decided to defer the case for want of comments of D/o C&PC

100

Case No.:309/5/82-

ALC4/2015
Party Name:SHREE VALLABH CHEMICAL Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00449/AM16/
RLA File :08/24/040/00417/AM15/
Lic.No/Date:0810134670 25.02.2015 Defer Date:09.03.2016 Decision :It was decided to defer the case for want of comments of D/o C&PC

101

Case No.:273/5/82-

ALC4/2015
Party Name:BHARAT SERUMS & VACCINES LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:0310794262 Defer

:01/82/050/00413/AM16/
:03/94/040/01055/AM15/
27.02.2015 Date:09.03.2016 Decision :The Committee decided to defer the case for want of comment from DBT

102

Case No.:452/5/82-

ALC4/2015
Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00592/AM16/
RLA File :03/94/040/01091/AM15/
Lic.No/Date:0310794261 27.02.2015 Defer Date:09.03.2016

103

Case No.:295/5/82-

ALC4/2015
Party Name:PROLIFE INDUSTRIES LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00435/AM16/
RLA File :08/24/040/00395/AM15/
Lic.No/Date:0810134703 03.03.2015 Defer Date:09.03.2016

104

Case No.:451/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00591/AM16/
RLA File :03/94/040/01097/AM15/
Lic.No/Date:0310794354 04.03.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comment from DoP.

105

Case No.:303/5/82-

ALC4/2015
Party Name:ASSOCIATED DYESTUFF PVT. LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00443/AM16/
RLA File :08/24/040/00422/AM15/
Lic.No/Date:0810134739 05.03.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comment from DoP

106

Case No.:300/5/82-

ALC4/2015
Party Name:ADVANCE PETROCHEMICALS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00440/AM16/
RLA File :08/24/040/00448/AM15/
Lic.No/Date:0810134768 11.03.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comment from DCPC.

107

Case No.:450/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00590/AM16/
RLA File :03/94/040/01114/AM15/
Lic.No/Date:0310794517 11.03.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comment from DoP

108

Case No.:447/5/82-

ALC4/2015
Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00587/AM16/
RLA File :03/94/040/01131/AM15/
Lic.No/Date:0310794543 12.03.2015 Defer Date:09.03.2016 Decision :The was decided to send a copy of application to DOP.

109

Case No.:409/5/82-

ALC4/2015
Party Name:NOCIL LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00549/AM16/
RLA File :03/95/040/00974/AM15/
Lic.No/Date:0310794587 16.03.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comment from DCPC.

110

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

INDUSTRIES Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00084/AM16/
RLA File :34/24/040/00325/AM15/
Lic.No/Date:3410041050 16.03.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comment from DCPC.

111

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

FORMULATIONS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00802/AM16/
RLA File :09/24/040/00690/AM15/
Lic.No/Date:0910061710 16.03.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comment from DoP

112

Case No.:291/5/82-

ALC4/2015
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00431/AM16/
RLA File :05/23/040/00544/AM15/
Lic.No/Date:0510393616 18.03.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comment from DCPC.

113

Case No.:426/5/82-ALC4/2015 Party Name:ENCUBE

ETHICALS PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/00566/AM16/
RLA File :03/94/040/01162/AM15/
Lic.No/Date:0310794710 19.03.2015 Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/216/2015-PI(Norms) dated 10.02.2016 uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

114 Case No.:407/5/82- Party Name:WANBURY Meet No/Date:18/82- Status:Case

ALC4/2015
LIMITED(FORMERLY PEARL ORGANICS LTD) ALC4/2015 10.02.2016 Deferred HQ File :01/82/050/00547/AM16/
RLA File :03/95/040/00934/AM15/
Lic.No/Date:0310794735 20.03.2015 Defer Date:09.03.2016 Decision :It was decided to send a copy of application to DoP.

115

Case No.:183/5/82-

ALC4/2015
Party Name:SPAK ORGOCHEM (INDIA) PVT. LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00323/AM16/
RLA File :03/95/040/00964/AM15/
Lic.No/Date:0310794811 23.03.2015 Defer Date:09.03.2016

116

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

DYESTUFF PVT. LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00169/AM16/
RLA File :08/24/040/00483/AM15/
Lic.No/Date:0810134917 25.03.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comment from DCPC.

117

Case No.:427/5/82-

ALC4/2015
Party Name:SHALINA Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00567/AM16/
RLA File :03/95/040/01071/AM15/
Lic.No/Date:0310794916 26.03.2015 Defer Date:09.03.2016 Decision The Committee noted that information called for from the firm in NC meeting No. 12 dated 18.11.2015 is awaited. The Committee accordingly decided await the

118

Case No.:431/5/82-

ALC4/2015
Party Name:EUROLIFE HEALTHCARE PVT. LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00571/AM16/
RLA File :03/94/040/01086/AM15/
Lic.No/Date:0310794964 27.03.2015 Defer Date:09.03.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.No. 35011/582/2013-PI(Norms) dated 24.12.2013, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

119

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

SCIENCES LIMITED. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00156/AM16/
RLA File :09/24/040/00736/AM15/
Lic.No/Date:0910061856 31.03.2015 Defer Date:09.03.2016

No. 12 dated 18.11.2015 is awaited. The Committee accordingly decided await the

120

Case No.:405/5/82-

ALC4/2015
Party Name:CTX LIFESCIENCES PVT LTD, Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00545/AM16/
RLA File :03/94/040/00521/AM15/
Lic.No/Date:0310795052 31.03.2015 Defer Date:09.03.2016 Decision : The Committee decided to defer the case for want of comments of DC&PC(Chemicals)/DOP.

121

Case No.:28/5/82-ALC4/2015 Party Name:RUCHI SOYA

INDUSTRIES LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00168/AM16/
RLA File :56/24/040/00064/AM15/
Lic.No/Date:5610004573 31.03.2015 Defer Date:09.03.2016 Decision :The Committee noted that information called for from the firm is awaited. The Committee accordingly decided await the reply and deferred the case.

122

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

CHEMICALS Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00166/AM16/
RLA File :08/24/040/00470/AM15/
Lic.No/Date:0810134992 07.04.2015 Defer Date:09.03.2016 No. 05 dated 25.06.2015 is awaited. The Committee accordingly decided await the

123

Case No.:411/5/82-

ALC4/2015
Party Name:SHALINA Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00551/AM16/
RLA File :03/95/040/01033/AM15/
Lic.No/Date:0310795186 08.04.2015 Defer Date:09.03.2016 No. 14 dated 16.12.2015 is awaited. The Committee accordingly decided await the

124

Case No.:139/8/82-ALC4/2015 Party Name:S.M. CHEMICALS Meet No/Date:18/82-

ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/00935/AM16/
RLA File :03/95/040/01120/AM15/
Lic.No/Date:0310795271 13.04.2015 Defer Date: D/o C&PC forwarded vide U.O.No.14010/64/2010-Ch-II dated 8.2.2016, uploaded along

125

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

PHARMA CHEM PVT.LTD, Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00145/AM16/
RLA File :08/24/040/00003/AM16/
Lic.No/Date:0810135051 17.04.2015 Defer Date:09.03.2016 No. 12 dated 18.11.2015 is awaited. The Committee accordingly decided await the

126

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

LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00175/AM16/
RLA File :09/24/040/00739/AM15/
Lic.No/Date:0910061891 17.04.2015 Defer Date:09.03.2016 Decision :The Committee considered the case for ratification of Norms and decided send a copy of application to DoP

127

Case No.:132/7/82-

ALC4/2015
Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 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:09.03.2016 DC&PC(Chemicals)

128

Case No.:153/7/82-

ALC4/2015
Party Name:DR. ACHARYA LABORATORIES PVT. LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00758/AM16/
RLA File :03/94/040/00039/AM16/
Lic.No/Date:0310795534 24.04.2015 Defer Date:09.03.2016 Decision :In the light of written comments received from D/o C&PC vide letter No.14010/9/2016-CH-II dated 11.2.2016, uploaded along with these minutes, it was decided to call for information from the firm:

129

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

SPECIALITIES PVT. LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00634/AM16/
RLA File :04/24/040/00003/AM16/
Lic.No/Date:0410160438 24.04.2015 Defer Date:09.03.2016 No. 14 dated 16.12.2015 is awaited. The Committee accordingly decided await the

130

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

CHIRALS PVT. LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00836/AM16/
RLA File :09/24/040/00042/AM16/
Lic.No/Date:0910061937 27.04.2015 Defer Date:09.03.2016

131

Case No.:174/5/82-

ALC4/2015
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00314/AM16/
RLA File :07/24/040/00393/AM15/
Lic.No/Date:0710108142 01.05.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comments of DC&PC.

132

Case No.:176/5/82-

ALC4/2015
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00316/AM16/
RLA File :07/24/040/00389/AM15/
Lic.No/Date:0710108141 01.05.2015 Defer Date:09.03.2016

133

Case No.:177/5/82-

ALC4/2015
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00317/AM16/
RLA File :07/24/040/00390/AM15/
Lic.No/Date:0710108143 01.05.2015 Defer Date:09.03.2016

134

Case No.:62/8/82-ALC4/2015 Party Name:OPTIMUS

DRUGS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00858/AM16/
RLA File :09/24/040/00028/AM16/
Lic.No/Date:0910061955 01.05.2015 Defer Date:09.03.2016 No. 14 dated 16.12.2015 is awaited. The Committee accordingly decided await the

135

Case No.:61/8/82-ALC4/2015 Party Name:RA CHEM

PHARMA LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/00857/AM16/
RLA File :09/24/040/00045/AM16/
Lic.No/Date:0910061970 01.05.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No35011/376/2012-PI(Norms) dated 1.4.2014 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

136

Case No.:111/7/82-

ALC4/2015
Party Name:ZIM LABORATORIES LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:0310795699 Defer

:01/82/050/00716/AM16/
:03/95/040/00058/AM16/
05.05.2015 Date:09.03.2016

137

Case No.:77/8/82-ALC4/2015 Party Name:GRANULES

INDIA LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case deferred HQ File :01/82/050/00873/AM16/
RLA File :09/24/040/00022/AM16/
Lic.No/Date:0910061978 06.05.2015 Defer Date: 22.03.2016

138

Case No.:78/8/82-ALC4/2015 Party Name:GRANULES

INDIA LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00874/AM16/
RLA File :09/24/040/00021/AM16/
Lic.No/Date:0910061977 06.05.2015 Defer Date:09.03.2016 Decision : The Committee based on the written comments forwarded by the D/o C&PC vide letter No.35011/648/2015-PI(Norms) dated 21.01.2016 uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

139

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

LABORATORIES PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00871/AM16/
RLA File :09/24/040/00051/AM16/
Lic.No/Date:0910061986 06.05.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comments of DoP.

140

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

BIOTECH PV T LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00861/AM16/
RLA File :09/24/040/00052/AM16/
Lic.No/Date:0910061973 06.05.2015 Defer Date:09.03.2016 No. 12 dated 18.11.2015 is awaited. The Committee accordingly decided await the

141

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

Party Name:S.M. HERBALS PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/00143/AM16/
RLA File :05/24/040/00014/AM16/
Lic.No/Date:0510394126 07.05.2015 Defer Date: Decision The Committee considered the case for revision of Norms under Para 4.07 of HBP as per agenda. It was observed that the D/o Pharmaceuticals has already forwarded their written comments vide O.M. No. 35011/417/2013-PI (Norms) dated 21.10.2013. The COA etc.

was available with them. In written comments of DCPC submitted on 16.2.2016 the wastage is given as 4%. In the DoP recommendation the wastage is 3.46 %. The representation of the firm is that the purity of export and import item was altered by the Norms Committee 5 years after completion of export and import at which time alteration of description endorsed on documents as per the licence is not possible. Accordingly the recommendation of DoP is adopted and the description of import as well as export will be same as already endorsed in the licence. The wastage allowed by the DCPC is 4%. The wastage allowed by DoP is 3.46% taking purity not more than 96.8%. Accordingly the wastage of 4% allowed by DCPC was found to be acceptable and the Committee allowed 4% wastage.

142

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

PVT.LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00147/AM16/
RLA File :05/23/040/00037/AM16/
Lic.No/Date:0510394177 08.05.2015 Defer Date:09.03.2016 No. 12 dated 18.11.2015 is awaited. The Committee accordingly decided await the

143

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

Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00834/AM16/
RLA File :09/24/040/00060/AM16/
Lic.No/Date:0910061998 08.05.2015 Defer Date:09.03.2016 No. 14 dated 16.12.2015 is awaited. The Committee accordingly decided await the

144

Case No.:69/8/82-ALC4/2015 Party Name:SRINI

PHARMACEUTICALS LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/00865/AM16/
RLA File :09/24/040/00742/AM15/
Lic.No/Date:0910061999 08.05.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No. 35011/681/2015-PI(Norms) dated 1.2.2016, uploaded along with these minutes or as applied by the firm whichever is less of NC.

145

Case No.:76/8/82-ALC4/2015 Party Name:AKTINOS

PHARMA PVT LTD, Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00872/AM16/
RLA File :09/24/040/00062/AM16/
Lic.No/Date:0910062007 12.05.2015 Defer Date:09.03.2016

146

Case No.:32/8/82-ALC4/2015 Party Name:ARENE LIFE

SCIENCES LIMITED. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00828/AM16/
RLA File :09/24/040/00040/AM16/
Lic.No/Date:0910062015 14.05.2015 Defer Date:09.03.2016 Decision :The Committee considered the case for ratification of Norms and decided send a copy of application to DoP.

147

Case No.:41/8/82-ALC4/2015 Party Name:AUROBINDO

PHARMA LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/00837/AM16/
RLA File :09/24/040/00074/AM16/
Lic.No/Date:0910062016 14.05.2015 Defer Date: D/o D/o Pharmaceuticals forwarded vide O.M. No.35011/651/2015-PI(Norms) dated 1.2.2016 , uploaded along with these minutes or as applied by the firm whichever is less of NC.

148

Case No.:42/8/82-ALC4/2015 Party Name:RA CHEM

PHARMA LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00838/AM16/
RLA File :09/24/040/00097/AM16/
Lic.No/Date:0910062057 21.05.2015 Defer Date:09.03.2016

149

Case No.:199/5/82-ALC4/2015 Party Name:SHASUN

PHARMACEUTICALS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00339/AM16/
RLA File :04/24/040/00040/AM16/
Lic.No/Date:0410160570 21.05.2015 Defer Date: No. 12 date18.11.2015 is awaited. The Committee accordingly decided await the reply

150

Case No.:200/5/82-

ALC4/2015
Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00340/AM16/
RLA File :04/24/040/00038/AM16/
Lic.No/Date:0410160569 21.05.2015 Defer Date:09.03.2016 No. 12 date18.11.2015 is awaited. The Committee accordingly decided await the reply

151

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

FINECHEM PVT. LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00893/AM16/
RLA File :08/24/040/00051/AM16/
Lic.No/Date:0810135338 22.05.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comments of DC&PC.

152

Case No.:29/8/82-ALC4/2015 Party Name:COVALENT

LABORATORIES PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00825/AM16/
RLA File :09/24/040/00734/AM15/
Lic.No/Date:0910062067 25.05.2015 Defer Date:09.03.2016

153

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

LABORATORIES LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00841/AM16/
RLA File :05/24/040/00073/AM16/
Lic.No/Date:0510394342 25.05.2015 Defer Date:09.03.2016

154

Case No.:136/8/82-ALC4/2015 Party Name:SEBACIC INDIA

LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/00932/AM16/
RLA File :34/24/040/00049/AM16/
Lic.No/Date:3410041253 28.05.2015 Defer Date:
D/o C&PC forwarded vide U.O.No.14010/79/2015-Ch-II dated 12.2.2016, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

155

Case No.:113/7/82-

ALC4/2015
Party Name:S.M. CHEMICALS Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/00718/AM16/
RLA File :03/95/040/00115/AM16/
Lic.No/Date:0310796312 29.05.2015 Defer Date:09.03.2016 D/o C&PC forwarded vide U.O.No.14010/64/2010-Ch-II dated 8.12.2015, uploaded

156

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

LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00882/AM16/
RLA File :09/24/040/00131/AM16/
Lic.No/Date:0910062091 29.05.2015 Defer Date:09.03.2016

157

Case No.:90/8/82-ALC4/2015 Party Name:UNITED

BIOTECH PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00886/AM16/
RLA File :05/24/040/00072/AM16/
Lic.No/Date:0510394446 04.06.2015 Defer Date:09.03.2016

158

Case No.:187/7/82-

ALC4/2015
Party Name:ATUL LIMITED, Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00792/AM16/
RLA File :08/24/040/00057/AM16/
Lic.No/Date:0810135435 05.06.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comments of DC&PC.

159

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

PVT. LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00803/AM16/
RLA File :09/24/040/00139/AM16/
Lic.No/Date:0910062135 05.06.2015 Defer Date:09.03.2016

160

Case No.:59/7/82-ALC4/2015 Party Name:GRANULES

INDIA LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Defer HQ File :01/82/050/00664/AM16/
RLA File :09/24/040/00149/AM16/
Lic.No/Date:0910062152 10.06.2015 Defer Date09.03.2016: Decision : The committee decided to defer the case for want of comment of DOP.

161

Case No.:59/8/82-ALC4/2015 Party Name:GRANULES

INDIA LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/00855/AM16/
RLA File :09/24/040/00140/AM16/
Lic.No/Date:0910062148 10.06.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No. 35011/648/2015-PI(Norms) dated 21.1.2016, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

162

Case No.:68/8/82-ALC4/2015 Party Name:GRANULES

INDIA LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/00864/AM16/
RLA File :09/24/040/00156/AM16/
Lic.No/Date:0910062147 10.06.2015 Defer Date:

D/o Pharmaceuticals forwarded vide O.M. No. 35011/648/2015-PI(Norms) dated 21.1.2016, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

163

Case No.:74/8/82-ALC4/2015 Party Name:GRANULES

INDIA LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00870/AM16/
RLA File :09/24/040/00127/AM16/
Lic.No/Date:0910062151 10.06.2015 Defer Date:22.03.2016 Decision : The committee decided to defer the case for want of comment of DOP.

164

Case No.:122/14/82-

ALC4/2015
Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01258/AM16/
RLA File :03/94/040/00914/AM15/
Lic.No/Date:0310796567 11.06.2015 Defer Date: D/o C&PC forwarded vide U.O.No.14010/57/2015-Ch-II dated 11.2.2016 uploaded

165

Case No.:177/7/82-ALC4/2015 Party Name:S.M. CHEMICALS Meet No/Date:18/82-

ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/00782/AM16/
RLA File :03/95/040/00124/AM16/
Lic.No/Date:0310796577 11.06.2015 Defer Date: D/o C&PC forwarded vide U.O.No.14010/64/2010-Ch-II dated 8.12.2015, uploaded

16 6

Case No.:47/14/82-

ALC4/2015
Party Name:SMILAX LABORATORIES LIMI TED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01183/AM 16/
RLA File :09/24/040/00155/AM16/
Lic.No/Date:09100621 67 11.06.2015 Defer Date:09.03.20 16

167

Case No.:121/8/82-

ALC4/2015
Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00917/AM16/
RLA File :03/95/040/00190/AM16/
Lic.No/Date:0310796766 23.06.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comments of DC&PC.

168

Case No.:56/8/82-ALC4/2015 Party Name:TRIMAX BIO

SCIENCES PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/00852/AM16/
RLA File :09/24/040/00718/AM15/
Lic.No/Date:0910062245 24.06.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/649/2015-PI(Norms) dated 21.1.2016 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

169

Case No.:128/16/82-

ALC4/2015
Party Name:FLAGSHIP BIOTECH INTERNATIONAL PVT. LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01448/AM16/
RLA File :03/94/040/00217/AM16/
Lic.No/Date:0310796903 26.06.2015 Defer Date:09.03.2016

170

Case No.:3/6/82-ALC4/2015 Party Name:AUROBINDO

PHARMA LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00599/AM16/
RLA File :09/24/040/00179/AM16/
Lic.No/Date:0910062259 30.06.2015 Defer Date:22.03.2016

171

Case No.:4/6/82-ALC4/2015 Party Name:HETERO LABS

LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00600/AM16/
RLA File :09/24/040/00188/AM16/
Lic.No/Date:0910062261 30.06.2015 Defer Date:09.03.2016

172

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

Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00601/AM16/
RLA File :34/24/040/00091/AM16/
Lic.No/Date:3410041336 01.07.2015 Defer Date:09.03.2016

173

Case No.:109/8/82-

ALC4/2015
Party Name:SHALINA Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00905/AM16/
RLA File :03/95/040/00038/AM16/
Lic.No/Date:0310796997 01.07.2015 Defer Date:09.03.2016 Decision :The Committee noted that information called for from the firm in Meeting no.

14/82 dated 16.12.2015 is awaited. The Committee accordingly decided await the reply

174

Case No.:97/14/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01233/AM16/
RLA File :09/24/040/00186/AM16/
Lic.No/Date:0910062271 01.07.2015 Defer Date:09.03.2016

175

Case No.:109/14/82-

ALC4/2015
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01245/AM16/
RLA File :09/24/040/00195/AM16/
Lic.No/Date:0910062283 02.07.2015 Defer Date:09.03.2016

176

Case No.:7/18/82-ALC4/2015 Party Name:SHODHANA

LABORATORIES LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Added HQ File :01/82/050/01472/AM16/
RLA File :09/24/040/00198/AM16/
Lic.No/Date:0910062275 02.07.2015 Defer Date:09.03.2016

177

Case No.:39/13/82-

ALC4/2015
Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case deferred HQ File :01/82/050/01002/AM16/
RLA File :03/94/040/00260/AM16/
Lic.No/Date:0310797052 03.07.2015 Defer Date:22.03.2016

178

Case No.:105/14/82-

ALC4/2015
Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01241/AM16/
RLA File :09/24/040/00191/AM16/
Lic.No/Date:0910062299 03.07.2015 Defer Date:09.03.2016

179

Case No.:28/14/82-

ALC4/2015
Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01164/AM16/
RLA File :05/24/040/00153/AM16/
Lic.No/Date:0510394804 06.07.2015 Defer Date:09.03.2016

180 Case No.:45/14/82-ALC4/2015 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:18/82- ALC4/2015 Status:Case Approved

10.02.2016 HQ File :01/82/050/01181/AM16/
RLA File :05/24/040/00162/AM16/
Lic.No/Date:0510394805 06.07.2015 Defer Date: D/o C&PC forwarded vide U.O.No.14010/58/2010-CH-II dated 16.2.2016 , uploaded

181

Case No.:98/8/82-ALC4/2015 Party Name:HONEST BIO-

VET PVT. LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00894/AM16/
RLA File :08/24/040/00109/AM16/
Lic.No/Date:0810135630 07.07.2015 Defer Date:09.03.2016

182

Case No.:43/14/82-

ALC4/2015
Party Name:INDO PHYTO CHEMICALS PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01179/AM16/
RLA File :05/23/040/00146/AM16/
Lic.No/Date:0510394837 08.07.2015 Defer Date:09.03.2016

183

Case No.:104/14/82-

ALC4/2015
Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01240/AM16/
RLA File :09/24/040/00701/AM15/
Lic.No/Date:0910062324 09.07.2015 Defer Date:09.03.2016

184

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

PVT.LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00850/AM16/
RLA File :05/23/040/00150/AM16/
Lic.No/Date:0510394862 09.07.2015 Defer Date:09.03.2016

185

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

BIOTECHNOLOGY PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00846/AM16/
RLA File :06/24/040/00014/AM16/
Lic.No/Date:0610038189 09.07.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comments of DBT.

186

Case No.:51/14/82-

ALC4/2015
Party Name:SRIAM LABS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred

HQ File :01/82/050/01187/AM16/
RLA File :09/24/040/00197/AM16/
Lic.No/Date:0910062326 13.07.2015 Defer Date:09.03.2016

187

Case No.:58/8/82-ALC4/2015 Party Name:INDO PHYTO

CHEMICALS PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/00854/AM16/
RLA File :05/23/040/00069/AM16/
Lic.No/Date:0510394892 14.07.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/683/2015-PI(Norms) dated 1.2.2016 , uploaded along with these minutes or as applied by the firm whichever is less of NC.

188

Case No.:72/8/82-ALC4/2015 Party Name:INDO PHYTO

CHEMICALS PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/00868/AM16/
RLA File :05/23/040/00068/AM16/
Lic.No/Date:0510394891 14.07.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/683/2015-PI(Norms) dated 1.2.2016 , uploaded along with these minutes or as applied by the firm whichever is less of NC.

189

Case No.:54/14/82-

ALC4/2015
Party Name:BIOLOGICAL E LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01190/AM16/
RLA File :09/24/040/00524/AM15/
Lic.No/Date:0910062332 15.07.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comments of DBT.

190

Case No.:59/14/82-

ALC4/2015
Party Name:BIOLOGICAL E LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01195/AM16/
RLA File :09/24/040/00525/AM15/
Lic.No/Date:0910062331 15.07.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comments of DBT.

191

Case No.:41/14/82-

ALC4/2015
Party Name:DEEPAK NITRITE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01177/AM16/
RLA File :34/24/040/00031/AM16/
Lic.No/Date:3410041376 15.07.2015 Defer Date:09.03.2016

192

Case No.:114/14/82-

ALC4/2015
Party Name:GRANULES INDIA LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01250/AM16/
RLA File :09/24/040/00651/AM15/
Lic.No/Date:0910062336 15.07.2015 Defer Date:09.03.2016

193

Case No.:20/16/82-

ALC4/2015
Party Name:MYLAN Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01340/AM16/
RLA File :09/24/040/00032/AM16/
Lic.No/Date:0910062338 15.07.2015 Defer Date:09.03.2016

194

Case No.:113/8/82-

ALC4/2015
Party Name:UNIJULES LIFE SCIENCES LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00909/AM16/
RLA File :03/95/040/00299/AM16/
Lic.No/Date:0310797251 15.07.2015 Defer Date:09.03.2016

195

Case No.:70/8/82-ALC4/2015 Party Name:ZEISS

PHARMACEUTICALS PVT.LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00866/AM16/
RLA File :22/24/040/00024/AM16/
Lic.No/Date:2210015267 15.07.2015 Defer Date:09.03.2016

196

Case No.:3/7/82-ALC4/2015

Party Name:DR REDDYS Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/00608/AM16/
RLA File :09/24/040/00202/AM16/
Lic.No/Date:0910062341 16.07.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/689/2015-PI(Norms) dated 1.2.2016 , uploaded along with these minutes or as applied by the firm whichever is less of NC.

197

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

INDUSTRIES Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00845/AM16/
RLA File :06/24/040/00015/AM16/
Lic.No/Date:0610038193 16.07.2015 Defer Date:09.03.2016 No.14 dated 16.12.2015 is awaited. The Committee accordingly decided await the

198

Case No.:113/14/82-

ALC4/2015
Party Name:NEULAND LABORATORIES LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01249/AM16/
RLA File :09/24/040/00192/AM16/
Lic.No/Date:0910062343 16.07.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/676/AM15-PI(Norms) dated 1.2.2016 , uploaded along with these minutes or as applied by the firm whichever is less of NC.

199

Case No.:120/8/82-

ALC4/2015
Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00916/AM16/
RLA File :03/95/040/00304/AM16/
Lic.No/Date:0310797293 16.07.2015 Defer Date:09.03.2016 vide letter No.14010/6/2016-Ch-II dated 27.01.2016, uploaded along with these minutes

200

Case No.:116/8/82-ALC4/2015 Party Name:PRASOL

CHEMICALS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/00912/AM16/
RLA File :03/95/040/00216/AM16/
Lic.No/Date:0310797284 16.07.2015 Defer Date: D/o C&PC forwarded vide U.O.No.14010/107/2011-Ch-II date 12.1.2016, uploaded

201

Case No.:55/8/82-ALC4/2015 Party Name:JUBILANT LIFE

SCIENCES LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00851/AM16/
RLA File :05/23/040/00142/AM16/
Lic.No/Date:0510394969 17.07.2015 Defer Date:09.03.2016

202

Case No.:49/14/82-

ALC4/2015
Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01185/AM16/
RLA File :09/24/040/00205/AM16/
Lic.No/Date:0910062344 17.07.2015 Defer Date:09.03.2016

203 Case No.:39/14/82- ALC4/2015
Party Name:JAGSONPAL PHARMACEUTICALS LTD. Meet No/Date:18/82- ALC4/2015 Status:Case Deferred

10.02.2016 HQ File :01/82/050/01175/AM16/
RLA File :05/23/040/00165/AM16/
Lic.No/Date:0510395004 20.07.2015 Defer Date:09.03.2016

204

Case No.:42/14/82-

ALC4/2015
Party Name:MEDICAMEN ORGANICS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01178/AM16/
RLA File :05/24/040/00193/AM16/
Lic.No/Date:0510395021 21.07.2015 Defer Date:09.03.2016

205

Case No.:112/14/82-

ALC4/2015
Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01248/AM16/
RLA File :09/24/040/00221/AM16/
Lic.No/Date:0910062348 21.07.2015 Defer Date:09.03.2016

206

Case No.:169/13/82-

ALC4/2015
Party Name:VASUDHA PHARMA CHEM LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01132/AM16/
RLA File :09/24/040/00177/AM16/
Lic.No/Date:0910062350 21.07.2015 Defer Date: Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.05/82 dated 25.6.2015, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

207

Case No.:21/16/82-

ALC4/2015
Party Name:OPTIMUS Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01341/AM16/
RLA File :09/24/040/00223/AM16/
Lic.No/Date:0910062361 22.07.2015 Defer Date:09.03.2016

208

Case No.:22/16/82-

ALC4/2015
Party Name:OPTIMUS Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01342/AM16/
RLA File :09/24/040/00224/AM16/
Lic.No/Date:0910062360 22.07.2015 Defer Date:09.03.2016

209

Case No.:150/14/82-

ALC4/2015
Party Name:HETERO DRUGS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:0910062366 Defer

:01/82/050/01286/AM16/
:09/24/040/00242/AM16/
23.07.2015 Date:09.03.2016

210

Case No.:1/8/82-ALC4/2015

Party Name:HETERO LABS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/00797/AM16/
RLA File :09/24/040/00236/AM16/
Lic.No/Date:0910062367 23.07.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/141/2015-PI(Norms) dated Oct. 2015 on repeat basis , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

211

Case No.:2/8/82-ALC4/2015 Party Name:HETERO LABS

LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00798/AM16/
RLA File :09/24/040/00246/AM16/
Lic.No/Date:0910062368 23.07.2015 Defer Date:09.03.2016

212

Case No.:3/8/82-ALC4/2015 Party Name:HETERO LABS

LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00799/AM16/
RLA File :09/24/040/00235/AM16/
Lic.No/Date:0910062369 23.07.2015 Defer Date:09.03.2016

213

Case No.:4/8/82-ALC4/2015 Party Name:HETERO LABS

LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00800/AM16/
RLA File :09/24/040/00237/AM16/
Lic.No/Date:0910062370 23.07.2015 Defer Date:09.03.2016

214

Case No.:50/14/82-

ALC4/2015
Party Name:SRIAM LABS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01186/AM16/
RLA File :09/24/040/00226/AM16/
Lic.No/Date:0910062363 23.07.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comments of DoP

215

Case No.:149/14/82-

ALC4/2015
Party Name:VISION DRUGS PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:0910062365 Defer

:01/82/050/01285/AM16/
:09/24/040/00230/AM16/
23.07.2015 Date:09.03.2016 Decision :The Committee based on the written comments forwarded by the D/o Pharmaceuticals O.M.No.35011/570/2015-PI(Norms) dated December 2015 , uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

216

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

PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00875/AM16/
RLA File :05/24/040/00110/AM16/
Lic.No/Date:0510395084 24.07.2015 Defer Date:09.03.2016

217

Case No.:10/8/82-ALC4/2015 Party Name:AUROBINDO

PHARMA LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00806/AM16/
RLA File :09/24/040/00215/AM16/
Lic.No/Date:0910062383 27.07.2015 Defer Date:09.03.2016

218

Case No.:115/8/82-

ALC4/2015
Party Name:MERCK LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00911/AM16/
RLA File :03/95/040/00321/AM16/
Lic.No/Date:0310797685 27.07.2015 Defer Date:09.03.2016

219

Case No.:117/8/82-ALC4/2015 Party Name:PRASOL

CHEMICALS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/00913/AM16/
RLA File :03/95/040/00250/AM16/
Lic.No/Date:0310797677 27.07.2015 Defer Date: D/o C&PC forwarded vide U.O.No.14010/107/2011-Ch-II dated 12.1.2016, uploaded

220

Case No.:11/8/82-ALC4/2015 Party Name:INTER LABS

(INDIA)PVT LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00807/AM16/
RLA File :09/24/040/00249/AM16/
Lic.No/Date:0910062391 28.07.2015 Defer Date:09.03.2016

221 Case No.:148/14/82- ALC4/2015
Party Name:MYLAN Meet No/Date:18/82- ALC4/2015 Status:Case Approved

10.02.2016 HQ File :01/82/050/01284/AM16/
RLA File :09/24/040/00099/AM16/
Lic.No/Date:0910062389 28.07.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/187/2015-PI(Norms) dated Oct. 2015, uploaded along with these minutes or as applied by the firm whichever is less of NC.

222

Case No.:73/8/82-ALC4/2015 Party Name:RECKITT

BENCKISER HEALTHCARE INDIA LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00869/AM16/
RLA File :05/24/040/00213/AM16/
Lic.No/Date:0510395102 28.07.2015 Defer Date:22.03.2016

223

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

& CHEMICALS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00957/AM16/
RLA File :09/24/040/00211/AM16/
Lic.No/Date:0910062393 28.07.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comments of DCPC

224

Case No.:12/8/82-ALC4/2015 Party Name:COVALENT

LABORATORIES PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00808/AM16/
RLA File :09/24/040/00250/AM16/
Lic.No/Date:0910062397 29.07.2015 Defer Date:09.03.2016

225

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

DRUGS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00809/AM16/
RLA File :09/24/040/00243/AM16/
Lic.No/Date:0910062398 29.07.2015 Defer Date:09.03.2016

226

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

DRUGS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00810/AM16/
RLA File :09/24/040/00241/AM16/
Lic.No/Date:0910062399 29.07.2015 Defer Date:09.03.2016

227 Case No.:15/8/82-ALC4/2015 Party Name:HETERO LABS Meet No/Date:18/82- Status:Case

LIMITED ALC4/2015 10.02.2016 Deferred HQ File :01/82/050/00811/AM16/
RLA File :09/24/040/00261/AM16/
Lic.No/Date:0910062400 29.07.2015 Defer Date:09.03.2016

228

Case No.:170/14/82-

ALC4/2015
Party Name:PI INDUSTRIES LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01306/AM16/
RLA File :13/24/040/00015/AM16/
Lic.No/Date:1310047932 29.07.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comments of DCPC.

229

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

PHARMA PVT LTD, Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00812/AM16/
RLA File :09/24/040/00229/AM16/
Lic.No/Date:0910062415 30.07.2015 Defer Date:09.03.2016

230

Case No.:131/14/82-

ALC4/2015
Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01267/AM16/
RLA File :09/24/040/00212/AM16/
Lic.No/Date:0910062413 30.07.2015 Defer Date:09.03.2016

231

Case No.:60/14/82-

ALC4/2015
Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01196/AM16/
RLA File :09/24/040/00256/AM16/
Lic.No/Date:0910062418 31.07.2015 Defer Date:09.03.2016

232

Case No.:169/14/82-

ALC4/2015
Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01305/AM16/
RLA File :31/83/040/00018/AM16/
Lic.No/Date:3110065573 03.08.2015 Defer Date:09.03.2016

233

Case No.:12/14/82-ALC4/2015 Party Name:MAC CHEM

PRODUCTS (INDIA) PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01148/AM16/
RLA File :03/95/040/00326/AM16/
Lic.No/Date:0310797879 03.08.2015 Defer Date:

D/o Pharmaceuticals forwarded vide O.M. No.35011/656/2015-PI(norms) dated 21.1.2016 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

234

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

LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00813/AM16/
RLA File :09/24/040/00251/AM16/
Lic.No/Date:0910062426 03.08.2015 Defer Date:09.03.2016

235

Case No.:165/14/82-

ALC4/2015
Party Name:BALAJI AMINES LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01301/AM16/
RLA File :31/83/040/00055/AM16/
Lic.No/Date:3110065577 04.08.2015 Defer Date: D/o C&PC forwarded vide U.O.No.14010/122/2011-Ch-II dated 11.2.2016, uploaded

236

Case No.:166/14/82-

ALC4/2015
Party Name:BALAJI AMINES LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01302/AM16/
RLA File :31/83/040/00054/AM16/
Lic.No/Date:3110065576 04.08.2015 Defer Date: D/o C&PC forwarded vide U.O.No.14010/122/2011-Ch-II dated 11.2.2016, uploaded

237

Case No.:167/14/82-

ALC4/2015
Party Name:BALAJI AMINES LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01303/AM16/
RLA File :31/83/040/00053/AM16/
Lic.No/Date:3110065578 04.08.2015 Defer Date: D/o C&PC forwarded vide U.O.No.14010/122/2011-Ch-II dated 11.2.2016, uploaded

238

Case No.:168/14/82-

ALC4/2015
Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred

HQ File :01/82/050/01304/AM16/
RLA File :31/83/040/00024/AM16/
Lic.No/Date:3110065579 04.08.2015 Defer Date:09.03.2016

239

Case No.:13/18/82-

ALC4/2015
Party Name:FINE ORGANIC INDUSTRIES PVT. LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01478/AM16/
RLA File :03/94/040/00334/AM16/
Lic.No/Date:0310797973 05.08.2015 Defer Date:09.03.2016

240

Case No.:12/18/82-

ALC4/2015
Party Name:OMTECH CHEMICAL INDUSTRIES PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01477/AM16/
RLA File :03/95/040/00345/AM16/
Lic.No/Date:0310797967 05.08.2015 Defer Date:09.03.2016

241

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

TECHNOLOGIES PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01149/AM16/
RLA File :03/95/040/00325/AM16/
Lic.No/Date:0310797969 05.08.2015 Defer Date: D/o C&PC forwarded vide U.O.No.14010/62/2010-CH-II dated 11.02.2016, uploaded

242

Case No.:95/14/82-

ALC4/2015
Party Name:BRUNDAVAN LABORATORIES PRIVATE LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01231/AM16/
RLA File :09/24/040/00216/AM16/
Lic.No/Date:0910062459 07.08.2015 Defer Date:09.03.2016

243

Case No.:19/8/82-ALC4/2015 Party Name:HETERO

DRUGS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00815/AM16/
RLA File :09/24/040/00267/AM16/
Lic.No/Date:0910062455 07.08.2015 Defer Date:09.03.2016

244

Case No.:18/8/82-ALC4/2015 Party Name:HONOUR LAB

LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:0910062454 Defer

:01/82/050/00814/AM16/
:09/24/040/00270/AM16/
07.08.2015 Date:09.03.2016

245

Case No.:14/14/82-

ALC4/2015
Party Name:ZIM LABORATORIES LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01150/AM16/
RLA File :03/95/040/00356/AM16/
Lic.No/Date:0310798008 07.08.2015 Defer Date:09.03.2016

246

Case No.:4/14/82-ALC4/2015 Party

Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01140/AM16/
RLA File :03/95/040/00350/AM16/
Lic.No/Date:0310798032 10.08.2015 Defer Date:09.03.2016

247

Case No.:18/14/82-

ALC4/2015
Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01154/AM16/
RLA File :03/95/040/00317/AM16/
Lic.No/Date:0310798039 10.08.2015 Defer Date:09.03.2016

248

Case No.:115/16/82-

ALC4/2015
Party Name:SHALINA Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01435/AM16/
RLA File :03/95/040/00164/AM16/
Lic.No/Date:0310798051 10.08.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comments of DoP..

249

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

FORMULATIONS P LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00819/AM16/
RLA File :09/24/040/00091/AM16/
Lic.No/Date:0910062478 11.08.2015 Defer Date:09.03.2016

250

Case No.:22/8/82-ALC4/2015 Party Name:GRANULES

INDIA LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00818/AM16/
RLA File :09/24/040/00287/AM16/
Lic.No/Date:0910062467 11.08.2015 Defer Date:09.03.2016

251 Case No.:31/14/82-ALC4/2015 Party Name:SONGWON SPECIALTY CHEMICALS Meet No/Date:18/82- ALC4/2015 Status:Case Approved

INDIA PVT. LTD. 10.02.2016 HQ File :01/82/050/01167/AM16/
RLA File :34/24/040/00134/AM16/
Lic.No/Date:3410041440 11.08.2015 Defer Date: D/o C&PC forwarded vide U.O.No.14010/10/2015-CH-II dated 12.2.2016 , uploaded

252

Case No.:155/14/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01291/AM16/
RLA File :05/24/040/00237/AM16/
Lic.No/Date:0510395271 11.08.2015 Defer Date:09.03.2016

253

Case No.:160/14/82-

ALC4/2015
Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01296/AM16/
RLA File :09/24/040/00286/AM16/
Lic.No/Date:0910062483 12.08.2015 Defer Date:09.03.2016

254

Case No.:25/8/82-ALC4/2015 Party Name:ARENE LIFE

SCIENCES LIMITED. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00821/AM16/
RLA File :09/24/040/00112/AM16/
Lic.No/Date:0910062498 13.08.2015 Defer Date:09.03.2016

255

Case No.:11/18/82-

ALC4/2015
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01476/AM16/
RLA File :03/95/040/00327/AM16/
Lic.No/Date:0310798117 13.08.2015 Defer Date:09.03.2016

256

Case No.:133/14/82-

ALC4/2015
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01269/AM16/
RLA File :09/24/040/00298/AM16/
Lic.No/Date:0910062500 14.08.2015 Defer Date:09.03.2016

257

Case No.:20/14/82-ALC4/2015 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File RLA File Lic.No/Date:0310798188 Defer Date:

:01/82/050/01156/AM16/
:03/95/040/00130/AM16/
14.08.2015 D/o C&PC forwarded vide U.O.No.14010/64/2013-CH-II dated 15.2.2016 , uploaded

258

Case No.:22/14/82-ALC4/2015 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01158/AM16/
RLA File :03/95/040/00077/AM16/
Lic.No/Date:0310798195 14.08.2015 Defer Date: D/o C&PC forwarded vide U.O.No.14010/64/2013-CH-II dated 15.2.2016 , uploaded

259

Case No.:69/14/82-ALC4/2015 Party Name:VIJAYASRI

ORGANICS LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01205/AM16/
RLA File :09/24/040/00217/AM16/
Lic.No/Date:0910062501 14.08.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M.No.35011/377/2014-PI(Norms) dated June 2015 , uploaded along with these minutes or as applied by the firm whichever is less of NC.

260

Case No.:34/14/82-

ALC4/2015
Party Name:TRANSPEK INDUSTRY LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01170/AM16/
RLA File :34/24/040/00144/AM16/
Lic.No/Date:3410041464 17.08.2015 Defer Date:09.03.2016 Decision :Copy of application has been sent to DCPC. The Committee decided to defer the case for want of comments of DCPC.

261

Case No.:26/8/82-ALC4/2015 Party Name:HONOUR LAB

LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00822/AM16/
RLA File :09/24/040/00292/AM16/
Lic.No/Date:0910062510 18.08.2015 Defer Date:09.03.2016

262

Case No.:96/14/82-

ALC4/2015
Party Name:MAITHRI LABORATORIES (P) LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01232/AM16/
RLA File :09/24/040/00293/AM16/
Lic.No/Date:0910062511 18.08.2015 Defer Date:09.03.2016

263

Case No.:99/14/82-

ALC4/2015
Party Name:OPTIMUS Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01235/AM16/
RLA File :09/24/040/00231/AM16/
Lic.No/Date:0910062516 18.08.2015 Defer Date:09.03.2016

264

Case No.:56/13/82-

ALC4/2015
Party Name:PANACEA BIOTEC LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01019/AM16/
RLA File :05/24/040/00183/AM16/
Lic.No/Date:0510395354 18.08.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comments of DBT.

265

Case No.:70/14/82-ALC4/2015 Party Name:NEULAND

LABORATORIES LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01206/AM16/
RLA File :09/24/040/00280/AM16/
Lic.No/Date:0910062520 19.08.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M.No.35011/676/2015-PI(Norms) dated 01.02.2016 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

266

Case No.:154/14/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01290/AM16/
RLA File :05/24/040/00381/AM15/
Lic.No/Date:0510395357 19.08.2015 Defer Date:09.03.2016

267

Case No.:68/14/82-

ALC4/2015
& CHEMICALS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01204/AM16/
RLA File :09/24/040/00368/AM15/
Lic.No/Date:0910062518 19.08.2015 Defer Date:09.03.2016

268

Case No.:30/14/82-

ALC4/2015
Party Name:BHARAT PARENTERALS LTD, Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01166/AM16/
RLA File :34/24/040/00143/AM16/
Lic.No/Date:3410041467 20.08.2015 Defer Date:09.03.2016

269

Case No.:6/14/82-ALC4/2015 Party Name:PREGNA

INTERNATIONAL LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01142/AM16/
RLA File :03/95/040/00364/AM16/
Lic.No/Date:0310798287 20.08.2015 Defer Date:09.03.2016

270

Case No.:133/16/82-

ALC4/2015
Party Name:VIJAYASRI ORGANICS LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01453/AM16/
RLA File :09/24/040/00013/AM16/
Lic.No/Date:0910062523 20.08.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M.No.35011/377/2014-PI(Norms) dated June 2015 , uploaded along with these minutes or as applied by the firm whichever is less of NC.

271

Case No.:19/14/82-ALC4/2015 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01155/AM16/
RLA File :03/95/040/00389/AM16/
Lic.No/Date:0310798289 20.08.2015 Defer Date: D/o C&PC forwarded vide U.O.No.14010/95/2011-Ch-II dated 23.11.2015 , uploaded

272

Case No.:66/14/82-

ALC4/2015
Party Name:SRIAM LABS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01202/AM16/
RLA File :09/24/040/00290/AM16/
Lic.No/Date:0910062526 21.08.2015 Defer Date:09.03.2016

273

Case No.:16/16/82-

ALC4/2015
Party Name:ALCHYMARS ICM SM PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Approved HQ File :01/82/050/01336/AM16/
RLA File :04/24/040/00128/AM16/
Lic.No/Date:0410160959 25.08.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M.No.35011/377/2014-PI(Norms) dated June 2015 , uploaded along with these minutes or as applied by the firm whichever is less of NC.

274

Case No.:28/8/82-ALC4/2015 Party Name:HETERO

DRUGS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00824/AM16/
RLA File :09/24/040/00313/AM16/
Lic.No/Date:0910062532 25.08.2015 Defer Date:09.03.2016

275

Case No.:23/14/82-

ALC4/2015
Party Name:RUSAN PHARMA LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01159/AM16/
RLA File :03/95/040/00400/AM16/
Lic.No/Date:0310798441 25.08.2015 Defer Date:09.03.2016

276

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

CHEMICALS PVT. LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01139/AM16/
RLA File :03/95/040/00401/AM16/
Lic.No/Date:0310798433 25.08.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comments of DCPC

277

Case No.:24/14/82-

ALC4/2015
Party Name:SHUBHAM SPECIALTY PRODUCTS Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01160/AM16/
RLA File :03/95/040/00348/AM16/
Lic.No/Date:0310798516 27.08.2015 Defer Date:09.03.2016

278

Case No.:35/14/82-

ALC4/2015
Party Name:VENUS REMEDIES LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01171/AM16/
RLA File :22/24/040/00032/AM16/
Lic.No/Date:2210015295 27.08.2015 Defer Date:09.03.2016

279

Case No.:36/14/82-

ALC4/2015
Party Name:VENUS REMEDIES LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01172/AM16/
RLA File :22/24/040/00034/AM16/
Lic.No/Date:2210015294 27.08.2015 Defer Date:09.03.2016

280

Case No.:133/8/82-

ALC4/2015
Party Name:AKTINOS HEALTHCARE PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00929/AM16/
RLA File :09/24/040/00227/AM16/
Lic.No/Date:0910062545 28.08.2015 Defer Date:09.03.2016

281

Case No.:131/8/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00927/AM16/
RLA File :09/24/040/00324/AM16/
Lic.No/Date:0910062542 28.08.2015 Defer Date:09.03.2016

282

Case No.:132/8/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00928/AM16/
RLA File :09/24/040/00325/AM16/
Lic.No/Date:0910062543 28.08.2015 Defer Date:09.03.2016

283

Case No.:82/14/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01218/AM16/
RLA File :05/24/040/00233/AM16/
Lic.No/Date:0510395480 31.08.2015 Defer Date:09.03.2016

284

Case No.:89/14/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01225/AM16/
RLA File :05/24/040/00224/AM16/
Lic.No/Date:0510395479 31.08.2015 Defer Date:09.03.2016

285

Case No.:94/14/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01230/AM16/
RLA File :05/24/040/00202/AM16/
Lic.No/Date:0510395481 31.08.2015 Defer Date:09.03.2016

286

Case No.:17/14/82-ALC4/2015 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01153/AM16/
RLA File :03/95/040/00414/AM16/
Lic.No/Date:0310798585 31.08.2015 Defer Date: D/o C&PC forwarded vide U.O.No.14010/95/2011-Ch-II dated 23.11.2015 , uploaded

287 Case No.:116/16/82- ALC4/2015
Party Name:PANERA BIOTEC PVT.LTD. Meet No/Date:18/82- ALC4/2015 Status:Case Deferred

10.02.2016 HQ File :01/82/050/01436/AM16/
RLA File :05/24/040/00181/AM16/
Lic.No/Date:0510395496 01.09.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comments of DBT.

288

Case No.:93/14/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01229/AM16/
RLA File :05/24/040/00244/AM16/
Lic.No/Date:0510395493 01.09.2015 Defer Date:09.03.2016

289

Case No.:134/8/82-

ALC4/2015
Party Name:HETERO DRUGS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00930/AM16/
RLA File :09/24/040/00336/AM16/
Lic.No/Date:0910062550 03.09.2015 Defer Date:09.03.2016

29 0

Case No.:57/14/82-

ALC4/2015
Party Name:SMILAX LABORATORIES LIMI TED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01193/AM 16/
RLA File :09/24/040/00322/AM16/
Lic.No/Date:09100625 47 03.09.2015 Defer Date:09.03.20 16

291

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

PVT LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01470/AM16/
RLA File :52/24/040/00039/AM16/
Lic.No/Date:5210041625 04.09.2015 Defer Date:09.03.2016

292

Case No.:141/14/82-

ALC4/2015
Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01277/AM16/
RLA File :17/24/040/00050/AM16/
Lic.No/Date:1710006170 04.09.2015 Defer Date:09.03.2016

293

Case No.:125/16/82-

ALC4/2015
Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01445/AM16/
RLA File :03/94/040/00171/AM16/
Lic.No/Date:0310798674 04.09.2015 Defer Date:09.03.2016

294

Case No.:52/14/82-

ALC4/2015
Party Name:OPTIMUS Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01188/AM16/
RLA File :09/24/040/00323/AM16/
Lic.No/Date:0910062554 04.09.2015 Defer Date:09.03.2016

295

Case No.:83/14/82-ALC4/2015 Party Name:V.D.H.

ORGANICS PVT. LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01219/AM16/
RLA File :05/24/040/00271/AM16/
Lic.No/Date:0510395542 07.09.2015 Defer Date: D/o C&PC forwarded vide U.O.No.14010/58/2010-CH-II dated 16.2.2016 , uploaded

296

Case No.:119/16/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01439/AM16/
RLA File :03/94/040/00402/AM16/
Lic.No/Date:0310798725 08.09.2015 Defer Date:09.03.2016

297

Case No.:120/16/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01440/AM16/
RLA File :03/94/040/00403/AM16/
Lic.No/Date:0310798726 08.09.2015 Defer Date:09.03.2016

298

Case No.:121/16/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01441/AM16/
RLA File :03/94/040/00405/AM16/
Lic.No/Date:0310798727 08.09.2015 Defer Date:09.03.2016

299

Case No.:172/13/82-

ALC4/2015
Party Name:LAKE CHEMICALS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01135/AM16/
RLA File :07/24/040/00201/AM16/
Lic.No/Date:0710108696 08.09.2015 Defer Date:09.03.2016

300

Case No.:56/14/82-

ALC4/2015
& CHEMICALS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01192/AM16/
RLA File :09/24/040/00134/AM16/
Lic.No/Date:0910062560 08.09.2015 Defer Date:09.03.2016

301

Case No.:124/16/82-

ALC4/2015
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01444/AM16/
RLA File :03/94/040/00399/AM16/
Lic.No/Date:0310798771 09.09.2015 Defer Date:09.03.2016 Decision : The Committee based on the written comments forwarded by the D/o C&PC vide letter No.14010/29/2011-Ch-II dated 15.02.2016, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

302

Case No.:46/14/82-

ALC4/2015
Party Name:MALWA OXYGEN & INDUSTRIAL GASES PVT.LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01182/AM16/
RLA File :56/24/040/00005/AM16/
Lic.No/Date:5610004674 09.09.2015 Defer Date:09.03.2016 Decision : The Committee based on the written comments forwarded by the D/o C&PC vide letter No.14010/08/2016-Ch-II dated 11.02.2016, uploaded along with these minutes decided to call for technical information from the firm and deferred the case

303

Case No.:53/14/82-

ALC4/2015
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01189/AM16/
RLA File :09/24/040/00315/AM16/
Lic.No/Date:0910062581 09.09.2015 Defer Date:09.03.2016

304

Case No.:157/14/82-

ALC4/2015
Party Name:AETHER INDUSTRIES LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01293/AM16/
RLA File :52/24/040/00042/AM16/
Lic.No/Date:5210041630 10.09.2015 Defer Date:09.03.2016 DC&PC(Chemicals)

305

Case No.:36/16/82-

ALC4/2015
Party Name:ALKYL AMINES CHEMICALS LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01356/AM16/
RLA File :03/94/040/00142/AM16/
Lic.No/Date:0310798803 10.09.2015 Defer Date:09.03.2016

DC&PC(Chemicals)

306

Case No.:147/14/82-

ALC4/2015
Party Name:GRANULES INDIA LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01283/AM16/
RLA File :09/24/040/00335/AM16/
Lic.No/Date:0910062586 10.09.2015 Defer Date:09.03.2016 Decision : The Committee based on the written comments forwarded by the D/o C&PC
vide letter No.35011/648/2015-PI(Norms) dated 21.01.2016 uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

307

Case No.:6/18/82-ALC4/2015 Party Name:INDO PHYTO

CHEMICALS PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01471/AM16/
RLA File :05/23/040/00235/AM16/
Lic.No/Date:0510395571 10.09.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No. 35011/433/2015-PI(Norms) dated oct. 2015, uploaded along with these minutes or as applied by the firm whichever is less of NC.

308

Case No.:122/16/82-

ALC4/2015
Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01442/AM16/
RLA File :03/94/040/00462/AM16/
Lic.No/Date:0310798808 10.09.2015 Defer Date:09.03.2016

309

Case No.:123/16/82-

ALC4/2015
Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01443/AM16/
RLA File :03/94/040/00463/AM16/
Lic.No/Date:0310798809 10.09.2015 Defer Date:09.03.2016

310

Case No.:125/14/82-

ALC4/2015
Party Name:OPTIMUS Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01261/AM16/
RLA File :09/24/040/00345/AM16/
Lic.No/Date:0910062589 10.09.2015 Defer Date:09.03.2016

311

Case No.:78/14/82-

ALC4/2015
Party Name:AMI LIFESCIENCES P LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred

HQ File :01/82/050/01214/AM16/
RLA File :34/24/040/00148/AM16/
Lic.No/Date:3410041505 11.09.2015 Defer Date:09.03.2016 DC&PC(Chemicals)

312

Case No.:4/16/82-ALC4/2015 Party Name:OPTIMUS

Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01324/AM16/
RLA File :09/24/040/00297/AM16/
Lic.No/Date:0910062594 11.09.2015 Defer Date:09.03.2016

313

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

Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01329/AM16/
RLA File :09/24/040/00328/AM16/
Lic.No/Date:0910062593 11.09.2015 Defer Date:09.03.2016

314

Case No.:95/16/82-ALC4/2015 Party Name:BALAJI AMINES

LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01415/AM16/
RLA File :31/83/040/00082/AM16/
Lic.No/Date:3110065636 14.09.2015 Defer Date: D/o C&PC forwarded vide U.O.No.14010/122/2011-Ch-II dated 11.2.2016, uploaded

315

Case No.:56/16/82-

ALC4/2015
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01376/AM16/
RLA File :03/94/040/00435/AM16/
Lic.No/Date:0310798876 14.09.2015 Defer Date:09.03.2016 Decision : The Committee based on the written comments forwarded by the D/o C&PC vide letter No.14010/29/2011-Ch-II dated 15.02.2016, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

316

Case No.:59/16/82-

ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01379/AM16/
RLA File :03/94/040/00474/AM16/
Lic.No/Date:0310798877 14.09.2015 Defer Date:09.03.2016

317 Case No.:9/18/82-ALC4/2015 Party Name:MYLAN Meet No/Date:18/82- Status:Case

ALC4/2015 10.02.2016 Approved HQ File :01/82/050/01474/AM16/
RLA File :09/24/040/00207/AM16/
Lic.No/Date:0910062619 14.09.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/423/2015-PI(Norms) dated Oct. 2015, uploaded along with these minutes or as applied by the firm whichever is less of NC.

318

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

ORGANICS LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01144/AM16/
RLA File :03/95/040/00343/AM16/
Lic.No/Date:0310798846 14.09.2015 Defer Date:09.03.2016 DC&PC(Chemicals)

319

Case No.:110/14/82-

ALC4/2015
& CHEMICALS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01246/AM16/
RLA File :09/24/040/00305/AM16/
Lic.No/Date:0910062601 14.09.2015 Defer Date:09.03.2016 DC&PC(Chemicals).

320

Case No.:134/14/82-

ALC4/2015
& CHEMICALS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01270/AM16/
RLA File :09/24/040/00273/AM16/
Lic.No/Date:0910062602 14.09.2015 Defer Date:09.03.2016

321

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

Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01143/AM16/
RLA File :03/95/040/00426/AM16/
Lic.No/Date:0310798872 14.09.2015 Defer Date:09.03.2016

322

Case No.:74/14/82-

ALC4/2015
Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01210/AM16/
RLA File :34/24/040/00120/AM16/
Lic.No/Date:3410041510 15.09.2015 Defer Date:09.03.2016 DC&PC(Chemicals)

323

Case No.:15/14/82-

ALC4/2015
Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01151/AM16/
RLA File :03/95/040/00360/AM16/
Lic.No/Date:0310798909 15.09.2015 Defer Date:09.03.2016 DC&PC(Chemicals)

324

Case No.:77/14/82-

ALC4/2015
Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01213/AM16/
RLA File :34/24/040/00164/AM16/
Lic.No/Date:3410041519 16.09.2015 Defer Date:09.03.2016

325

Case No.:96/16/82-ALC4/2015 Party Name:CLEAN SCIENCE

AND TECHNOLOGY PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01416/AM16/
RLA File :31/83/040/00083/AM16/
Lic.No/Date:3110065637 16.09.2015 Defer Date: Decision : Already approved in 16/82 dated 14.1.2016.

326

Case No.:100/14/82-

ALC4/2015
Party Name:ORCH LABORATORIES INDIA PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01236/AM16/
RLA File :09/24/040/00351/AM16/
Lic.No/Date:0910062623 16.09.2015 Defer Date:09.03.2016

327

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

VITAMINS PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01145/AM16/
RLA File :03/95/040/00434/AM16/
Lic.No/Date:0310798944 16.09.2015 Defer Date:09.03.2016 Decision : The Committee based on the written comments forwarded by the D/o C&PC vide letter No.14010/3/2016-Ch-II dated 11.2.2016, uploaded along with these minutes

328

Case No.:72/14/82-ALC4/2015 Party Name:SONGWON

SPECIALTY CHEMICALS INDIA PVT. LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01208/AM16/
RLA File :34/24/040/00168/AM16/
Lic.No/Date:3410041517 16.09.2015 Defer Date: D/o C&PC forwarded vide U.O.No.14010/10/2015-CH-II dated 12.2.2016 , uploaded

329

Case No.:98/14/82-

ALC4/2015
Party Name:SRINI PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01234/AM16/
RLA File :09/24/040/00333/AM16/
Lic.No/Date:0910062625 16.09.2015 Defer Date:09.03.2016

330

Case No.:115/14/82-

ALC4/2015
Party Name:SRINI PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01251/AM16/
RLA File :09/24/040/00334/AM16/
Lic.No/Date:0910062626 16.09.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/681/2015-PI(Norms) dated 1.2.2016 , uploaded along with these minutes or as applied by the firm whichever is less of NC.

331

Case No.:124/14/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01260/AM16/
RLA File :09/24/040/00355/AM16/
Lic.No/Date:0910062622 16.09.2015 Defer Date:09.03.2016 DC&PC(Chemicals)

332

Case No.:35/16/82-

ALC4/2015
Party Name:D. R. COATS INK & RESINS PVT. LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01355/AM16/
RLA File :03/94/040/00415/AM16/
Lic.No/Date:0310798977 21.09.2015 Defer Date:09.03.2016 DC&PC(Chemicals)

333

Case No.:34/16/82-

ALC4/2015
Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01354/AM16/
RLA File :03/94/040/00472/AM16/
Lic.No/Date:0310798979 21.09.2015 Defer Date:09.03.2016

334

Case No.:71/14/82-

ALC4/2015
Party Name:MYLAN Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred

HQ File :01/82/050/01207/AM16/
RLA File :09/24/040/00376/AM16/
Lic.No/Date:0910062633 21.09.2015 Defer Date:09.03.2016

335

Case No.:173/13/82-

ALC4/2015
Party Name:LAKE CHEMICALS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01136/AM16/
RLA File :07/24/040/00200/AM16/
Lic.No/Date:0710108760 22.09.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M.No.35011/249/2015-PI(Norms) dated Sept. 2015 dated 1.2.2016 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

336

Case No.:64/14/82-

ALC4/2015
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01200/AM16/
RLA File :09/24/040/00375/AM16/
Lic.No/Date:0910062644 22.09.2015 Defer Date:09.03.2016

337

Case No.:117/14/82-

ALC4/2015
Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01253/AM16/
RLA File :04/24/040/00140/AM16/
Lic.No/Date:0410161044 22.09.2015 Defer Date:09.03.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.No.35011/342/2015-PI(Norms) dated November 2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

338

Case No.:118/14/82-

ALC4/2015
Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01254/AM16/
RLA File :04/24/040/00139/AM16/
Lic.No/Date:0410161045 22.09.2015 Defer Date:09.03.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.No.35011/342/2015-PI(Norms) dated November 2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

339

Case No.:16/14/82-

ALC4/2015
Party Name:SUPRIYA LIFESCIENCE LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:0310798994 Defer

:01/82/050/01152/AM16/
:03/95/040/01072/AM15/
22.09.2015 Date:09.03.2016

340

Case No.:103/14/82-

ALC4/2015
Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01239/AM16/
RLA File :09/24/040/00362/AM16/
Lic.No/Date:0910062635 22.09.2015 Defer Date:09.03.2016 No. 14 dated 16.12.2015 is awaited. The Committee accordingly decided await the

341

Case No.:106/14/82-

ALC4/2015
Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01242/AM16/
RLA File :09/24/040/00373/AM16/
Lic.No/Date:0910062649 23.09.2015 Defer Date:09.03.2016

342

Case No.:85/14/82-ALC4/2015 Party Name:V.D.H.

ORGANICS PVT. LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01221/AM16/
RLA File :05/24/040/00302/AM16/
Lic.No/Date:0510395716 23.09.2015 Defer Date: D/o C&PC forwarded vide U.O.No.14010/58/2010-CH-II dated 16.2.2016 , uploaded

343

Case No.:91/14/82-

ALC4/2015
Party Name:CURETECH SKINCARE Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01227/AM16/
RLA File :22/21/040/00029/AM16/
Lic.No/Date:2210015316 24.09.2015 Defer Date:09.03.2016

344

Case No.:4/10/82-ALC4/2015 Party Name:HETERO

DRUGS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00960/AM16/
RLA File :09/24/040/00385/AM16/
Lic.No/Date:0910062662 24.09.2015 Defer Date:09.03.2016

345 Case No.:3/10/82-ALC4/2015 Party Name:HETERO LABS LIMITED Meet No/Date:18/82- ALC4/2015 Status:Case Deferred

10.02.2016 HQ File :01/82/050/00959/AM16/
RLA File :09/24/040/00378/AM16/
Lic.No/Date:0910062661 24.09.2015 Defer Date:09.03.2016

346

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

LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00958/AM16/
RLA File :09/24/040/00377/AM16/
Lic.No/Date:0910062660 24.09.2015 Defer Date:09.03.2016 DC&PC(Chemicals)

347

Case No.:70/16/82-

ALC4/2015
Party Name:IPCA Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01390/AM16/
RLA File :03/94/040/00505/AM16/
Lic.No/Date:0310799056 24.09.2015 Defer Date:09.03.2016

348

Case No.:86/14/82-

ALC4/2015
Party Name:BELLAPREMIER HAPPY HYGIENECARE PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01222/AM16/
RLA File :35/24/040/00005/AM16/
Lic.No/Date:3510044794 25.09.2015 Defer Date:09.03.2016 DC&PC(Chemicals)

349

Case No.:88/14/82-ALC4/2015 Party Name:S.M. HERBALS

PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01224/AM16/
RLA File :05/24/040/00279/AM16/
Lic.No/Date:0510395748 28.09.2015 Defer Date: Decision : The Committee considered the case for revision of Norms under Para 4.07 of HBP as per agenda. It was observed that the D/o Pharmaceuticals has already forwarded their written comments vide O.M. No. 35011/417/2013-PI (Norms) dated 21.10.2013. The COA etc. was available with them. In written comments of DCPC submitted on 16.2.2016 the wastage is given as 4%. In the DoP recommendation the wastage is 3.46 %. The representation of the firm is that the purity of export and import item was altered by the Norms Committee 5 years after completion of export and import at which time alteration of description endorsed on documents as per the licence is not possible. Accordingly the recommendation of DoP is adopted and the description of import as well as export will be same as already endorsed in the licence. The wastage allowed by the DCPC is 4%. The wastage allowed by DoP is 3.46% taking purity not more than 96.8%. Accordingly the wastage of 4% allowed by DCPC was found to be acceptable and the Committee allowed 4% wastage.

350

Case No.:65/14/82-

ALC4/2015
& CHEMICALS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01201/AM16/
RLA File :09/24/040/00291/AM16/
Lic.No/Date:0910062665 28.09.2015 Defer Date:09.03.2016 DC&PC(Chemicals)

351

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

LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01328/AM16/
RLA File :09/24/040/00294/AM16/
Lic.No/Date:0910062666 28.09.2015 Defer Date:09.03.2016 DC&PC(Chemicals)

352

Case No.:68/16/82-

ALC4/2015
Party Name:ZIM LABORATORIES LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01388/AM16/
RLA File :03/95/040/00454/AM16/
Lic.No/Date:0310799077 28.09.2015 Defer Date:09.03.2016

353

Case No.:79/14/82-

ALC4/2015
Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01215/AM16/
RLA File :05/23/040/00274/AM16/
Lic.No/Date:0510395773 30.09.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comments of AYUSH.

354

Case No.:6/10/82-ALC4/2015 Party Name:ARCHIMEDIS

Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00962/AM16/
RLA File :09/24/040/00321/AM16/
Lic.No/Date:0910062670 30.09.2015 Defer Date:09.03.2016

355

Case No.:69/16/82-

ALC4/2015
Party Name:PIDILITE INDUSTRIES LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01389/AM16/
RLA File :03/95/040/00350/AM15/
Lic.No/Date:0310799113 30.09.2015 Defer Date:09.03.2016 DC&PC(Chemicals)

356 Case No.:8/18/82-ALC4/2015 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:18/82- ALC4/2015 Status:Case Approved

10.02.2016 HQ File :01/82/050/01473/AM16/
RLA File :34/24/040/00160/AM16/
Lic.No/Date:3410041570 01.10.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No. 35011/153/2014-PI(Norms) dated Oct. 2015, uploaded along with these minutes or as applied by the firm whichever is less of NC.

357

Case No.:33/16/82-

ALC4/2015
Party Name:BLISS INDASI LIFESCIENCES PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01353/AM16/
RLA File :03/94/040/00483/AM16/
Lic.No/Date:0310799128 01.10.2015 Defer Date:09.03.2016

358

Case No.:83/16/82-ALC4/2015 Party Name:DSM SINOCHEM

PHARMACEUTICALS INDIA PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01403/AM16/
RLA File :22/24/040/00045/AM16/
Lic.No/Date:2210015321 01.10.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No. 35011/437/2013-PI(Norms) dated Oct. 2013, uploaded along with these minutes or as applied by the firm whichever is less of NC.

359

Case No.:55/16/82-

ALC4/2015
Party Name:DORF-KETAL CHEMICALS INDIA PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01375/AM16/
RLA File :03/94/040/00525/AM16/
Lic.No/Date:0310799188 05.10.2015 Defer Date:09.03.2016 DC&PC(Chemicals)

360

Case No.:43/16/82-

ALC4/2015
Party Name:INDOFIL INDUSTRIES LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01363/AM16/
RLA File :03/94/040/00423/AM16/
Lic.No/Date:0310799184 05.10.2015 Defer Date:09.03.2016 DC&PC(Chemicals)

361

Case No.:10/16/82-

ALC4/2015
& CHEMICALS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred

HQ File :01/82/050/01330/AM16/
RLA File :09/24/040/00266/AM16/
Lic.No/Date:0910062673 05.10.2015 Defer Date:09.03.2016 DC&PC(Chemicals)

362

Case No.:65/16/82-

ALC4/2015
Party Name:RELIANCE INDUSTRIES LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01385/AM16/
RLA File :03/95/040/00355/AM16/
Lic.No/Date:0310799215 06.10.2015 Defer Date:09.03.2016 DC&PC(Chemicals)

363

Case No.:66/16/82-ALC4/2015 Party Name:RELIANCE

INDUSTRIES LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01386/AM16/
RLA File :03/95/040/00392/AM16/
Lic.No/Date:0310799216 06.10.2015 Defer Date: D/o C&PC forwarded vide U.O.No.46011/113/2009-PC-II dated 23.07. 2015, uploaded

364

Case No.:67/16/82-

ALC4/2015
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01387/AM16/
RLA File :03/95/040/00485/AM16/
Lic.No/Date:0310799241 06.10.2015 Defer Date:09.03.2016

365

Case No.:126/14/82-

ALC4/2015
Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01262/AM16/
RLA File :05/23/040/00285/AM16/
Lic.No/Date:0510395839 07.10.2015 Defer Date:09.03.2016

366

Case No.:129/14/82-

ALC4/2015
Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01265/AM16/
RLA File :05/23/040/00281/AM16/
Lic.No/Date:0510395837 07.10.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M. No.35011/643/2015-PI(Norms) dated 1.2.2016, uploaded along with these minutes or as applied by the firm whichever is less

of NC.

367

Case No.:7/10/82-ALC4/2015 Party Name:DIVIS

LABORATORIES LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/00963/AM16/
RLA File :09/24/040/00384/AM16/
Lic.No/Date:0910062684 07.10.2015 Defer Date:09.03.2016

368

Case No.:6/16/82-ALC4/2015 Party Name:HETERO

DRUGS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01326/AM16/
RLA File :09/24/040/00404/AM16/
Lic.No/Date:0910062686 07.10.2015 Defer Date:09.03.2016

369

Case No.:45/16/82-

ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01365/AM16/
RLA File :03/94/040/00529/AM16/
Lic.No/Date:0310799266 07.10.2015 Defer Date:09.03.2016

370

Case No.:25/16/82-

ALC4/2015
Party Name:OPTIMUS Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01345/AM16/
RLA File :09/24/040/00347/AM16/
Lic.No/Date:0910062681 07.10.2015 Defer Date:09.03.2016

371

Case No.:64/16/82-

ALC4/2015
Party Name:ORION CHEM PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01384/AM16/
RLA File :03/95/040/00493/AM16/
Lic.No/Date:0310799254 07.10.2015 Defer Date:09.03.2016 DC&PC(Chemicals)

372

Case No.:139/14/82-

ALC4/2015
Party Name:MAMTA POLYCOATS Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01275/AM16/
RLA File :34/24/040/00178/AM16/
Lic.No/Date:3410041581 08.10.2015 Defer Date:09.03.2016 DC&PC(Chemicals)

373

Case No.:126/16/82-

ALC4/2015
Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01446/AM16/
RLA File :03/95/040/00445/AM16/
Lic.No/Date:0310799287 08.10.2015 Defer Date:09.03.2016 DC&PC(Chemicals)

374

Case No.:61/16/82-

ALC4/2015
Party Name:SHALINA Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01381/AM16/
RLA File :03/95/040/00483/AM16/
Lic.No/Date:0310799284 08.10.2015 Defer Date:09.03.2016

375

Case No.:62/16/82-

ALC4/2015
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01382/AM16/
RLA File :03/95/040/00491/AM16/
Lic.No/Date:0310799292 08.10.2015 Defer Date:09.03.2016 DC&PC(Chemicals)

376

Case No.:17/16/82-

ALC4/2015
Party Name:VISION DRUGS PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01337/AM16/
RLA File :09/24/040/00402/AM16/
Lic.No/Date:0910062693 08.10.2015 Defer Date:09.03.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.No.35011/467/2015-PI(Norms) dated November 2015 uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

377

Case No.:39/16/82-ALC4/2015 Party Name:KRISHNA

ANTIOXIDANTS PVT. LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01359/AM16/
RLA File :03/94/040/00535/AM16/
Lic.No/Date:0310799307 09.10.2015 Defer Date: D/o Pharmaceuticals forwarded vide U.O.No.14010/100/2012-Ch-II dated 15.2.2016, uploaded along with these minutes or as applied by the firm whichever is less under

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

378 Case No.:40/16/82-ALC4/2015 Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:18/82- ALC4/2015 Status:Case Approved

10.02.2016 HQ File :01/82/050/01360/AM16/
RLA File :03/94/040/00534/AM16/
Lic.No/Date:0310799303 09.10.2015 Defer Date: D/o Pharmaceuticals forwarded vide U.O.No.14010/100/2012-Ch-II dated 15.2.2016 , uploaded along with these minutes or as applied by the firm whichever is less under

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

379

Case No.:23/16/82-

ALC4/2015
Party Name:SHREEGEN PHARMA LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01343/AM16/
RLA File :09/24/040/00359/AM16/
Lic.No/Date:0910062695 09.10.2015 Defer Date:09.03.2016

380

Case No.:164/14/82-

ALC4/2015
Party Name:AASHA BIOCHEM Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01300/AM16/
RLA File :10/24/040/00049/AM16/
Lic.No/Date:1010059293 12.10.2015 Defer Date:09.03.2016

381

Case No.:82/16/82-

ALC4/2015
Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01402/AM16/
RLA File :22/24/040/00048/AM16/
Lic.No/Date:2210015329 12.10.2015 Defer Date:09.03.2016

382

Case No.:38/16/82-

ALC4/2015
Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01358/AM16/
RLA File :03/94/040/00536/AM16/
Lic.No/Date:0310799342 12.10.2015 Defer Date:09.03.2016

383

Case No.:140/14/82-

ALC4/2015
Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01276/AM16/
RLA File :34/24/040/00175/AM16/
Lic.No/Date:3410041586 12.10.2015 Defer Date:09.03.2016 DC&PC(Chemicals)

384

Case No.:63/16/82-

ALC4/2015
Party Name:SUPRIYA LIFESCIENCE LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred

HQ File :01/82/050/01383/AM16/
RLA File :03/95/040/00387/AM16/
Lic.No/Date:0310799377 13.10.2015 Defer Date:09.03.2016

385

Case No.:76/16/82-

ALC4/2015
Party Name:SUPRIYA LIFESCIENCE LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01396/AM16/
RLA File :03/95/040/00357/AM16/
Lic.No/Date:0310799376 13.10.2015 Defer Date:09.03.2016

386

Case No.:144/14/82-

ALC4/2015
Party Name:AMI ORGANICS PVT LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01280/AM16/
RLA File :52/24/040/00049/AM16/
Lic.No/Date:5210041658 14.10.2015 Defer Date:09.03.2016 DC&PC(Chemicals)

387

Case No.:58/16/82-

ALC4/2015
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01378/AM16/
RLA File :03/94/040/00497/AM16/
Lic.No/Date:0310799433 14.10.2015 Defer Date:09.03.2016

388

Case No.:132/14/82-

ALC4/2015
Party Name:RIDDHI PHARMA Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01268/AM16/
RLA File :34/24/040/00180/AM16/
Lic.No/Date:3410041592 14.10.2015 Defer Date:09.03.2016 Decision :It was decided to send a copy of application to DCPC.

389

Case No.:24/16/82-

ALC4/2015
& CHEMICALS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01344/AM16/
RLA File :09/24/040/00380/AM16/
Lic.No/Date:0910062727 14.10.2015 Defer Date:09.03.2016 DC&PC(Chemicals)

390

Case No.:152/14/82-

ALC4/2015
Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01288/AM16/
RLA File :05/24/040/00335/AM16/
Lic.No/Date:0510395899 14.10.2015 Defer Date:

D/o C&PC forwarded vide U.O.No.14010/58/2010 dated 16.2.2016, uploaded along

391

Case No.:60/16/82-

ALC4/2015
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01380/AM16/
RLA File :03/94/040/00486/AM16/
Lic.No/Date:0310799460 15.10.2015 Defer Date:09.03.2016

392

Case No.:92/16/82-

ALC4/2015
Party Name:TRANSPEK INDUSTRY LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01412/AM16/
RLA File :34/24/040/00185/AM16/
Lic.No/Date:3410041600 15.10.2015 Defer Date:09.03.2016 Decision :It was decided to send a copy of application to DCPC.

393

Case No.:54/16/82-ALC4/2015 Party Name:AVA

CHEMICALS PVT.LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01374/AM16/
RLA File :03/94/040/00517/AM16/
Lic.No/Date:0310799491 16.10.2015 Defer Date: D/o Pharmaceuticals forwarded vide U.O.No.14010/67/2011-Ch-II dated 30.9.2015 , uploaded along with these minutes or as applied by the firm whichever is less under

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

394

Case No.:57/16/82-

ALC4/2015
Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01377/AM16/
RLA File :03/94/040/00470/AM16/
Lic.No/Date:0310799489 16.10.2015 Defer Date:09.03.2016 DC&PC(Chemicals)

395

Case No.:71/16/82-ALC4/2015 Party Name:AVA

CHEMICALS PVT.LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01391/AM16/
RLA File :03/94/040/00479/AM16/
Lic.No/Date:0310799490 16.10.2015 Defer Date: D/o Pharmaceuticals forwarded vide U.O.No.14010/67/2011-Ch-II dated 02.9.2015, uploaded along with these minutes or as applied by the firm whichever is less under

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

396 Case No.:158/14/82- Party Name:JODAS EXPOIM Meet No/Date:18/82- Status:Case

ALC4/2015
PVT.LTD., ALC4/2015 10.02.2016 Deferred HQ File :01/82/050/01294/AM16/
RLA File :05/23/040/00305/AM16/
Lic.No/Date:0510395945 16.10.2015 Defer Date:09.03.2016

397

Case No.:137/14/82-

ALC4/2015
Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01273/AM16/
RLA File :05/23/040/00275/AM16/
Lic.No/Date:0510395972 19.10.2015 Defer Date: DC&PC(Chemicals)

398

Case No.:101/16/82-

ALC4/2015
Party Name:SONGWON SPECIALTY CHEMICALS INDIA PVT. LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01421/AM16/
RLA File :34/24/040/00179/AM16/
Lic.No/Date:3410041611 19.10.2015 Defer Date: D/o C&PC forwarded vide U.O.No.14010/10/2015-CH-II dated 12.2.2016 , uploaded

399

Case No.:77/16/82-

ALC4/2015
Party Name:LACTOSE (INDIA) LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01397/AM16/
RLA File :03/95/040/00481/AM16/
Lic.No/Date:0310799561 20.10.2015 Defer Date:09.03.2016

400

Case No.:26/16/82-

ALC4/2015
Party Name:NEULAND LABORATORIES LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01346/AM16/
RLA File :09/24/040/00370/AM16/
Lic.No/Date:0910062746 20.10.2015 Defer Date:09.03.2016

401

Case No.:11/16/82-

ALC4/2015
Party Name:OPTIMUS Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01331/AM16/
RLA File :09/24/040/00425/AM16/
Lic.No/Date:0910062758 20.10.2015 Defer Date:09.03.2016

402

Case No.:111/16/82-

ALC4/2015
Party Name:PI INDUSTRIES LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved

HQ File :01/82/050/01431/AM16/
RLA File :13/24/040/00030/AM16/
Lic.No/Date:1310048016 20.10.2015 Defer Date: D/o C&PC forwarded vide U.O.No.15022/28/2012-Ch-II dated 04.02.2016 , uploaded

403

Case No.:156/14/82-

ALC4/2015
Party Name:SOFTGEL HEALTH CARE PVT. LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01292/AM16/
RLA File :04/24/040/00158/AM16/
Lic.No/Date:0410161133 20.10.2015 Defer Date:09.03.2016

404

Case No.:27/16/82-

ALC4/2015
Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01347/AM16/
RLA File :09/24/040/00420/AM16/
Lic.No/Date:0910062753 20.10.2015 Defer Date:09.03.2016

405

Case No.:72/16/82-

ALC4/2015
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01392/AM16/
RLA File :03/95/040/00102/AM16/
Lic.No/Date:0310799579 21.10.2015 Defer Date:09.03.2016

406

Case No.:73/16/82-

ALC4/2015
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01393/AM16/
RLA File :03/95/040/00087/AM16/
Lic.No/Date:0310799578 21.10.2015 Defer Date:09.03.2016

407

Case No.:85/16/82-

ALC4/2015
Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01405/AM16/
RLA File :22/24/040/00046/AM16/
Lic.No/Date:2210015335 23.10.2015 Defer Date:09.03.2016

408

Case No.:29/16/82-

ALC4/2015
& CHEMICALS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01349/AM16/
RLA File :09/24/040/00379/AM16/
Lic.No/Date:0910062768 23.10.2015 Defer Date:09.03.2016

409

Case No.:30/16/82-

ALC4/2015
& CHEMICALS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01350/AM16/
RLA File :09/24/040/00383/AM16/
Lic.No/Date:0910062767 23.10.2015 Defer Date:09.03.2016

410

Case No.:129/16/82-

ALC4/2015
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01449/AM16/
RLA File :03/95/040/00505/AM16/
Lic.No/Date:0310799628 23.10.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comments of DCPC

411

Case No.:161/14/82-

ALC4/2015
Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01297/AM16/
RLA File :03/94/040/01226/AM15/
Lic.No/Date:0310799680 26.10.2015 Defer Date:09.03.2016

412

Case No.:78/16/82-

ALC4/2015
Party Name:MOHINI ORGANICS PVT. LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01398/AM16/
RLA File :03/95/040/00777/AM15/
Lic.No/Date:0310799666 26.10.2015 Defer Date:09.03.2016 vide letter No.14010/10/2016-Ch-II dated 11.02.2016, uploaded along with these minutes

41 3

Case No.:93/16/82-

ALC4/2015
Party Name:JAINEX SPECIALITY CHEMIC AL Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case 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:09.03.201 6

414

Case No.:31/16/82-

ALC4/2015
Party Name:MSN LABORATORIES PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01351/AM16/
RLA File :09/24/040/00423/AM16/
Lic.No/Date:0910062790 28.10.2015 Defer Date:09.03.2016

415

Case No.:74/16/82-

ALC4/2015
Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01394/AM16/
RLA File :03/95/040/00518/AM16/
Lic.No/Date:0310799705 28.10.2015 Defer Date:09.03.2016

416

Case No.:15/16/82-ALC4/2015 Party Name:SATYADEVA

PHARMACEUTICALS PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01335/AM16/
RLA File :09/24/040/00444/AM16/
Lic.No/Date:0910062787 28.10.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M.No.35011/647/2014-PI(Norms) dated May 2015 , uploaded along with these minutes or as applied by the firm whichever is less of NC.

417

Case No.:86/16/82-

ALC4/2015
Party Name:SAURAV CHEMICALS LTD, Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01406/AM16/
RLA File :22/24/040/00056/AM16/
Lic.No/Date:2210015337 28.10.2015 Defer Date:09.03.2016

418

Case No.:75/16/82-

ALC4/2015
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01395/AM16/
RLA File :03/95/040/00525/AM16/
Lic.No/Date:0310799704 28.10.2015 Defer Date:09.03.2016

419

Case No.:46/16/82-ALC4/2015 Party Name:TITAN

Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01366/AM16/
RLA File :03/95/040/00328/AM16/
Lic.No/Date:0310799744 28.10.2015 Defer Date: D/o Pharmaceuticals forwarded vide O.M.No.35011/170/2014-PI(Norms) dated Oct. 2014 , uploaded along with these minutes or as applied by the firm whichever is less of NC.

420

Case No.:134/16/82-

ALC4/2015
Party Name:METROCHEM API PVT. LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01454/AM16/
RLA File :09/24/040/00453/AM16/
Lic.No/Date:0910062796 29.10.2015 Defer Date:09.03.2016

421

Case No.:145/14/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01281/AM16/
RLA File :05/24/040/00250/AM16/
Lic.No/Date:0510396054 29.10.2015 Defer Date:09.03.2016

422

Case No.:151/14/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01287/AM16/
RLA File :05/24/040/00308/AM16/
Lic.No/Date:0510396056 29.10.2015 Defer Date:09.03.2016

423

Case No.:10/18/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01475/AM16/
RLA File :05/24/040/00295/AM16/
Lic.No/Date:0510396055 29.10.2015 Defer Date:09.03.2016

424

Case No.:47/16/82-

ALC4/2015
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01367/AM16/
RLA File :03/95/040/00526/AM16/
Lic.No/Date:0310799853 29.10.2015 Defer Date:09.03.2016

425

Case No.:136/14/82-

ALC4/2015
Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01272/AM16/
RLA File :05/23/040/00293/AM16/
Lic.No/Date:0510396078 30.10.2015 Defer Date:09.03.2016

426

Case No.:48/16/82-

ALC4/2015
Party Name:O C SPECIALITIES PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01368/AM16/
RLA File :03/95/040/00549/AM16/
Lic.No/Date:0310799873 30.10.2015 Defer Date:09.03.2016

427

Case No.:117/16/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred

HQ File :01/82/050/01437/AM16/
RLA File :05/24/040/00255/AM16/
Lic.No/Date:0510396073 30.10.2015 Defer Date:09.03.2016

428

Case No.:87/16/82-

ALC4/2015
Party Name:SCOTT-EDIL PHARMACIA LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01407/AM16/
RLA File :22/24/040/00020/AM16/
Lic.No/Date:2210015341 30.10.2015 Defer Date:09.03.2016

429

Case No.:159/14/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01295/AM16/
RLA File :05/24/040/00343/AM16/
Lic.No/Date:0510396075 30.10.2015 Defer Date:09.03.2016

430

Case No.:118/16/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01438/AM16/
RLA File :05/24/040/00345/AM16/
Lic.No/Date:0510396076 30.10.2015 Defer Date:09.03.2016

431

Case No.:84/16/82-

ALC4/2015
Party Name:VENUS REMEDIES LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01404/AM16/
RLA File :22/24/040/00055/AM16/
Lic.No/Date:2210015339 30.10.2015 Defer Date:09.03.2016

432

Case No.:107/16/82-

ALC4/2015
Party Name:HELLO PAINTS (P) LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01427/AM16/
RLA File :05/23/040/00326/AM16/
Lic.No/Date:0510396204 03.11.2015 Defer Date:09.03.2016

433

Case No.:50/16/82-ALC4/2015 Party Name:TITAN

Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01370/AM16/
RLA File :03/95/040/00563/AM16/
Lic.No/Date:0310799971 03.11.2015 Defer Date: Decision : : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/170/2014-PI(Norms) dated Oct. 2014, uploaded along with these minutes or as applied by the firm whichever is less

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

434

Case No.:19/16/82-

ALC4/2015
Party Name:MEDICLONE BIO-TECH PRIVATE LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01339/AM16/
RLA File :04/24/040/00181/AM16/
Lic.No/Date:0410161279 04.11.2015 Defer Date:09.03.2016 Decision :The Committee decided to defer the case for want of comments of DBT.

435

Case No.:90/16/82-

ALC4/2015
Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01410/AM16/
RLA File :34/24/040/00207/AM16/
Lic.No/Date:3410041662 05.11.2015 Defer Date:09.03.2016

436

Case No.:108/16/82-

ALC4/2015
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01428/AM16/
RLA File :05/23/040/00330/AM16/
Lic.No/Date:0510396254 05.11.2015 Defer Date:09.03.2016

437

Case No.:88/16/82-

ALC4/2015
Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01408/AM16/
RLA File :34/24/040/00202/AM16/
Lic.No/Date:3410041663 05.11.2015 Defer Date:09.03.2016 Decision : The Committee based on the written comments forwarded by the D/o C&PC vide letter No.14010/164/2011-Ch-II dated 11.2.2016, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

438

Case No.:52/16/82-

ALC4/2015
Party Name:UNIMAX LABORATORIES PVT.LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01372/AM16/
RLA File :03/95/040/00555/AM16/
Lic.No/Date:0310800046 05.11.2015 Defer Date:09.03.2016

439

Case No.:37/16/82-

ALC4/2015
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01357/AM16/
RLA File :03/94/040/00561/AM16/
Lic.No/Date:0310800114 06.11.2015 Defer Date:09.03.2016

440

Case No.:53/16/82-

ALC4/2015
Party Name:LAXMI ORGANIC INDUSTRIES LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01373/AM16/
RLA File :03/95/040/00540/AM16/
Lic.No/Date:0310800090 06.11.2015 Defer Date:09.03.2016

441

Case No.:89/16/82-

ALC4/2015
Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01409/AM16/
RLA File :34/24/040/00203/AM16/
Lic.No/Date:3410041666 09.11.2015 Defer Date:09.03.2016 vide letter No.14010/49/2011-Ch-II dated 11.02.2016, uploaded along with these minutes

442

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

MEDICAL KITS PVT. LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01322/AM16/
RLA File :04/24/040/00175/AM16/
Lic.No/Date:0410161296 09.11.2015 Defer Date:09.03.2016 Decision : The Committee based on the written comments forwarded by the D/o Biotechnology vide O.M.No.BT/IL/05/420/2016-PID dated 12.2.2016 uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

443

Case No.:18/16/82-

ALC4/2015
Party Name:CAPLIN POINT LABORATORIES LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01338/AM16/
RLA File :04/24/040/00172/AM16/
Lic.No/Date:0410161300 12.11.2015 Defer Date:09.03.2016

444

Case No.:110/16/82-

ALC4/2015
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01430/AM16/
RLA File :05/23/040/00329/AM16/
Lic.No/Date:0510396325 13.11.2015 Defer Date:09.03.2016

445

Case No.:106/16/82-

ALC4/2015
Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01426/AM16/
RLA File :05/24/040/00384/AM16/
Lic.No/Date:0510396340 16.11.2015 Defer Date:09.03.2016

446

Case No.:114/16/82-

ALC4/2015
Party Name:SHIVA BIOCHEM INDUSTRIES Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01434/AM16/
RLA File :50/24/040/00017/AM16/
Lic.No/Date:5010002240 16.11.2015 Defer Date:09.03.2016 Decision : The Committee based on the written comments forwarded by the Ministry of Food Processing Industries vide O.M.No.4(4)2016-DGFT dated 05.2.2016 uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

447

Case No.:100/16/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01420/AM16/
RLA File :05/24/040/00212/AM16/
Lic.No/Date:0510396349 17.11.2015 Defer Date:09.03.2016

448

Case No.:104/16/82-

ALC4/2015
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01424/AM16/
RLA File :05/23/040/00339/AM16/
Lic.No/Date:0510396384 20.11.2015 Defer Date:09.03.2016

449

Case No.:103/16/82-

ALC4/2015
Party Name:JUBILANT GENERICS LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01423/AM16/
RLA File :05/23/040/00337/AM16/
Lic.No/Date:0510396395 23.11.2015 Defer Date:09.03.2016

450

Case No.:79/16/82-

ALC4/2015
Party Name:VENUS REMEDIES LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01399/AM16/
RLA File :22/24/040/00074/AM16/
Lic.No/Date:2210015349 23.11.2015 Defer Date:09.03.2016

451

Case No.:81/16/82-

ALC4/2015
Party Name:VENUS REMEDIES LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01401/AM16/
RLA File :22/24/040/00075/AM16/
Lic.No/Date:2210015348 23.11.2015 Defer Date:09.03.2016

452

Case No.:105/16/82-

ALC4/2015
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01425/AM16/
RLA File :05/23/040/00356/AM16/
Lic.No/Date:0510396410 24.11.2015 Defer Date:09.03.2016

453

Case No.:32/16/82-

ALC4/2015
Party Name:INTERMED, Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01352/AM16/
RLA File :04/24/040/00177/AM16/
Lic.No/Date:0410161343 26.11.2015 Defer Date:09.03.2016

454

Case No.:171/14/82-

ALC4/2015
Party Name:ALKYL AMINES CHEMICALS LTD Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01307/AM16/
RLA File :03/94/040/00533/AM16/
Lic.No/Date:0310800496 30.11.2015 Defer Date:09.03.2016

455

Case No.:175/14/82-

ALC4/2015
Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Approved HQ File :01/82/050/01311/AM16/
RLA File :09/24/040/00471/AM16/
Lic.No/Date:0910062934 04.12.2015 Defer Date: Decision :Already approved in NC 14 dated 16.12.2015

456

Case No.:127/16/82-

ALC4/2015
Party Name:BLUELINE FOODS (INDIA) PVT.LTD, Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01447/AM16/
RLA File :07/24/040/00267/AM16/
Lic.No/Date:0710109146 08.12.2015 Defer Date:09.03.2016

457

Case No.:135/16/82-

ALC4/2015
Party Name:METROCHEM API PVT. LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01455/AM16/
RLA File :09/24/040/00534/AM16/
Lic.No/Date:0910062981 17.12.2015 Defer Date:09.03.2016

458

Case No.:136/16/82-

ALC4/2015
Party Name:METROCHEM API PVT. LTD. Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01456/AM16/
RLA File :09/24/040/00533/AM16/
Lic.No/Date:0910062980 17.12.2015 Defer Date:09.03.2016

459

Case No.:130/16/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01450/AM16/
RLA File :09/24/040/00575/AM16/
Lic.No/Date:0910063030 23.12.2015 Defer Date:09.03.2016

460

Case No.:132/16/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01452/AM16/
RLA File :09/24/040/00563/AM16/
Lic.No/Date:0910063042 28.12.2015 Defer Date: 22.03.2015

461

Case No.:131/16/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01451/AM16/
RLA File :09/24/040/00578/AM16/
Lic.No/Date:0910063038 28.12.2015 Defer Date:09.03.2016

462

Case No.:1/18/82-ALC4/2015 Party Name:HETERO LABS

LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01466/AM16/
RLA File :09/24/040/00615/AM16/
Lic.No/Date:0910063156 22.01.2016 Defer Date:09.03.2016

463

Case No.:2/18/82-ALC4/2015 Party Name:HETERO LABS

LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01467/AM16/
RLA File :09/24/040/00617/AM16/
Lic.No/Date:0910063157 22.01.2016 Defer Date:09.03.2016

464

Case No.:4/18/82-ALC4/2015 Party Name:DISTO

PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01469/AM16/
RLA File :09/24/040/00579/AM16/
Lic.No/Date:0910063172 27.01.2016 Defer Date:

465

Case No.:3/18/82-ALC4/2015 Party Name:HETERO LABS

LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:0910063171 Defer

:01/82/050/01468/AM16/
:09/24/040/00631/AM16/
27.01.2016 Date:09.03.2016

466

Case No.:14/18/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:18/82- ALC4/2015 10.02.2016 Status:Case Deferred HQ File :01/82/050/01479/AM16/
RLA File :09/24/040/00624/AM16/
Lic.No/Date:0910063184 28.01.2016 Defer Date:09.03.2016

Manual Agenda of NC Meeting No. 18/82/2016 Scheduled to be held on 10.02.2016

Case No. B- 01

M.No.18/AM-16 Date 10.02.2016

M/s. S.M Herbals Pvt Ltd File No. 01/82/050/00240/AM 12 RLA No.05/24/040/00626/AM 08 Adv.Auth. No. 0510212663 dated. 27.11.2007

Decision: The Committee considered the case for revision of Norms under Para 4.07 of HBP as per agenda. It was observed that the D/o Pharmaceuticals has already forwarded their written comments vide O.M. No. 35011/417/2013-PI (Norms) dated 21.10.2013. The COA etc. was available with them.
In written comments of DCPC submitted on 16.2.2016 the wastage is given as 4%. In the DoP recommendation the wastage is 3.46 %. The representation of the firm is that the purity of export and import item was altered by the Norms Committee 5 years after completion of export and import at which time alteration of description endorsed on documents as per the licence is not possible. Accordingly the recommendation of DoP is adopted and the description of import as well as export will be same as already endorsed in the licence. The wastage allowed by the DCPC is 4%. The wastage allowed by DoP is 3.46% taking purity not more than 96.8%.
Accordingly the wastage of 4% allowed by DCPC was found to be acceptable and the Committee allowed 4% wastage.

Case No. B- 02

M.No.18/AM-16 Date 10.02.2016

M/s. S.M Herbals Pvt Ltd File No. 01/85/171/00022/AM 15 RLA No.05/24/040/00199/AM 12 Adv.Auth. No. 0510302808 dated. 19.09.2011

per agenda. It was observed that the D/o Pharmaceuticals has already forwarded their written comments vide O.M. No. 35011/417/2013-PI (Norms) dated 21.10.2013. The COA etc. was available with them.
In written comments of DCPC submitted on 16.2.2016 the wastage is given as 4%. In the DoP recommendation the wastage is 3.46 %. The representation of the firm is that the purity of export and import item was altered by the Norms Committee 5 years after completion of export and import at which time alteration of description endorsed on documents as per the licence is not

possible. Accordingly the recommendation of DoP is adopted and the description of import as well as export will be same as already endorsed in the licence. The wastage allowed by the DCPC is 4%. The wastage allowed by DoP is 3.46% taking purity not more than 96.8%.
Accordingly the wastage of 4% allowed by DCPC was found to be acceptable and the Committee allowed 4% wastage.

Case No. B- 03

M.No.18/AM-16 Date 10.02.2016

M/s. Bharat Parenterals Ltd File No. 01/82/162/00277/AM 16 RLA No.34/21/040/00231/AM 13 Adv.Auth. No. 3410035162 dated. 17.09.2012

per agenda. The Committee decided to defer the case for want of comments of DoP.

Case No. B- 04

M.No.18/AM-16 Date 10.02.2016

File No. 01/82/162/00276/AM 16 RLA No.34/21/040/00154/AM 12 Adv.Auth. No. 3410030783 dated. 30.06.2011

per agenda. The Committee decided to defer the case for want of comments of DoP.

Case No. B- 05

M.No.18/AM-16 Date 10.02.2016

File No. 01/82/162/00275/AM 16 RLA No.34/21/040/00153/AM 12 Adv.Auth. No. 3410030739 dated. 28.06.2011

per agenda. The Committee decided to defer the case for want of comments of DoP.

Case No. B- 06

M.No.18/AM-16 Date 10.02.2016

File No. 01/82/162/00274/AM 16 RLA No.34/21/040/00037/AM 14 Adv.Auth. No. 3410036739 dated. 30.04.2013

per agenda. The Committee decided to defer the case for want of comments of DoP.

Case No. B- 07

M.No.18/AM-16 Date 10.02.2016 File No. 01/82/162/00273/AM 16 RLA No.34/21/040/00281/AM 14

Adv.Auth. No. 3410038101 dated. 03.10.2013

per agenda. The Committee decided to defer the case for want of comments of DoP

Case No. B- 08

M.No.18/AM-16 Date 10.02.2016

File No. 01/82/162/00272/AM 16 RLA No.34/21/040/00235/AM 14 Adv.Auth. No. 3410037816 dated. 04.09.2013

per agenda. The Committee decided to defer the case for want of comments of DoP.

Case No. B- 09

M.No.18/AM-16 Date 10.02.2016

File No. 01/82/162/00271/AM 16 RLA No.34/21/040/00324/AM 14 Adv.Auth. No. 3410038353 dated. 29.10.2013

per agenda. The Committee decided to defer the case for want of comments of DoP.

Case No. B- 10

M.No.18/AM-16 Date 10.02.2016

File No. 01/82/162/00270/AM 16 RLA No.34/21/040/00282/AM 14 Adv.Auth. No. 3410038122 dated. 04.10.2013

per agenda. The Committee decided to defer the case for want of comments of DoP.

ノ `' ≦ /′ ′ヽ /ο ノ Govemment of lndia Ministry of Chemicals and Fertilizers Department of Chemicals and Petrochemicals

Subject: Advance Authorization application from M/s. Deepak Nitrite Ltd for the import of raw

material against the export of 3- Trifluoromethyl Aceto Phenone (Advance Authorization No. 3410036142 dated 1S2.20i3.) M/s. Deepak Nitrite Ltd have submitted present apptication for the import of raw material against the export of 3- Trifluoromethyl Aceto phenone. The application has been examined and the Department recommends the following norms for the present Advance Authorization application. Thas issues with the approval of competent authority Addl lndustrial Adviser Tel No 011‐23381430 '1. ltem of Export Qty Item of lmport Qty 3-Trifluoromethyl Aceto Phenone. l k9 3 AMINO BENZO TRIFLUORIDE 1 606 kg Sodum Nl面te 0708k9 TOLUENE 0 730 kg CAuSTiC soDA LYE 47% 4 028 kg ACETALDOXIME 50% MIN SOLUTION IN WATER 1 178 kg COPPER SuLPHATE 0155k9 ACETIC ACID 0 200 kg SuLPHAMiC ACID 0020k9 SODA ASH 0 069 kg (A K AGARWAL) Deptt Of C&Pc u o No 14010/36′2012-CH― ‖ dated 8 12 2015 Shqh FTDO(D DG De h―

′ S′ ´′。 Government of lndia Subject: Advance Authonza10n applcation from M′ s New A‖ ance Dye‐Chem Pvt Ltd,for the import of raw mate百ai against the expOrt of NTA TRISODIUM POVVDER (TRISODIUM NITRILOTRIACETATE)INTA POWDERI (Advance Autho「zation No 0310792689 dated 08 1 2015) Ref UO No 01′ 82′ 050′262/AM‐ 16.181 dated 29 6 2015 M/s NewA‖ance Dye―Chem Pvt Ltd have submitted present applcat on for the import of raw matena aga nst the export of EDTA TR:SODlUM TRIHYDRATE(TRISODlUM EDTA TRIHYDRATE) The app‖ cation has been examined and the Departmentrecoml¬ ends the fo‖ owing norlns fOr the present Advance AuthonzatiOn applcation This issues with the approval of competent authodty. Addl industrial Adviser Tel No 011-23381430

ltem of Export Qtv Item of lmport Qty NTA TRlSODIUM POWDER (TRISODIUM NITRILOTRIACETATE)[NTA POWDERl l kg l NITR LO TRIACETIC ACID(NTA ACID) 0 771 kg (A K ACARWAL) Sinqh Deptt Of C&PC U O No 14010/13′ 2012-CH ldated 5102015 -11

ノθ 一ダ厖 /´ Subject: GoVernment ofindia Dep酬‖評話器騰謂霧」席ユ i∽に Advanoe AuthOttZalon applCatton from M′ S VDH Chem Tech PVt Ltd fO「 the import Of raw material againstthe export BHT(Butylated HydiOXy TOluene) (AdVance Authorization No 0510388792 dated 18 6 2014) Refi U O No 01′ 82/050′566′ AM-15′DES‐ 3′1210 dated 3 3 2015 Mis. VDH Chem Tech Pvt' Ltd' has submitted present application for the import of raw ,rt"ri"i ,!"ii"t t. "xport of BHT (Butylated Hydroxy Toluene)' The application has been examined and the Department recommends the lollowing norms for the piesent Advance Authorization application ¨ ′Meta Para 2 1SO Butytene i. a-Ht lautYated ttYdroxY Toluene). 2. Meta Cresol This issue with the approval of competent authority' Addl lndustrial Adviser Tel No 011‐3381430 a6('^(6 (A.K, AGARWAL) | hr Deptt of C&PCu O No 14010′ 58′2010 dated 16 2 2016

To, M′s Dhanllasi Moratti ChemicaI Co Limmed Prosped Chambers,317/21 DR D N Road, Mumbai400001, Subject: Application from lr/s. Dharmasi l,ilorarji Chemical Co Limited, for the impo( of raw- material against the export of N- Phenyl Benzene Sulfonamide. I am directed to refer to your Advance Authorization application received from Office of DGFT on above mentioned subject. You are again being advised to submit the following information within 15 days ot the issue of this letter: 1. Balanced chemical reactions indicating no. of moles of reactants/producls with molecular weight, o/o yield at different stages of manufacluring process with technical justification and authentic printed literature in support ol the claims,/quantity of raw materials applied for import. Details of production of export product under reference in the yeat 2013-14 and 2014- '15 and corresponding consumption of raw-materials duly certified by C.A. Any other relevant information. Yours faithfully, (A K ACARWAL) 3 F. No 1 4010/6/201 5-C H I I Government of lndia lrinistry of Chemicals and Ferlilizers Chemical Division /8 gメんの ShastH Bhavan,New Deihi‐ 110001 Datedi 1 0th Apr‖ ,2015 Addl lndustrial Advise「 Tel No 011‐23381430 Co●vt●: Shtt Manender v k「am Singh,FTD0 01′ 82′ 050′ 1253/AM‐ 15′DES-3′ 1218, (DES-3),n reference to DGFT/UONo― dated 3 3 2015

F No 14010′ 72/2014‐ CH‐ 11 Government oflndia Dep酬∬ :kま麒謂殿」席iicds Shastri Bhavan, Dated: To, M′ s He‖ O Paints P Ltd l′2234,Ram Nagar,Shahdara, Near Pandi ChOWk, Delh‐ 110032 釦Ц e∝酬器i柵轟躍』縞覧器お蔵“ (Advance Authorization No 0510395351 dated 18'08'2015) I am directed to reter to your Advance Authorization application received through Offlce ofDGFTonthesubjectmentionedabove'lnthisconnection,youarerequestedtosubmitthe following inlormation within 15 days of the issue of this letter'

Specific details of item of export and rmport with copy.of adva":". "*ll91-t:ii""
Detailed manufaclunng process, material balance with balanced chemical reactions

i"iiliino slaqe-wise &icentage yield along with the technical justification enclosing it "r"*,tti "rri"nti" printed tecin,ial literatuie rn support of vield or quantity of items lor import. : ri"iJii!- ii production of THYMoL (ABovE 95o/" PURITY) ^and- -conesponding " ;;;;;ptiJ;i;;cific each of the raw materials in the vear 2014-'15 and 2015-16 (Aprilto September) duly certified by CA may be furnished'

Any other relevant information New Delh1110004 27th」anuary.2016 import of raw-material against the Yours fanhfu‖ y, (A K ACχRWAL) Addl lndustnal Adviser Tel No 011-23381430 Conv to: Mahender Vikram Singh, FTDO.(DES‐ 3) n reference to DGFT/UONo‐ 01′ 82/050′01623′ AM‐ 16′DES‐ |‖′1521,dated 12 01 2016 斗多メD0 、マ(ヽtlも

Sublect From Date To BT′ IL′0,′ '16′ 2010 Applicat on of M′s Panacea BiOtec Ltd`DGFT Ref 01′ 82′050′01517′ AM‐ 16′ DES‐ ‖′652 dated 16 02 2016 ′∂ ′み^ろg9 Daled:29022016 Ni」n KumarJain DBTくnilnkJain@niC in> Monday,February 29 2016 4:34 pm MahendraV kram Shgh FTDOくncO d“ @nc n> Dear Mr. SinSh This h6 reference b DOFT U. O. No. 0 u82l050/0151?/At!r- 16/DES-llr l652 dated 16.02.2016. The applicadon of Mh Poaca Bioi€c Lrd., Ncw Delhi for the cxpon of " DTwP-HepB-Hib-Pentavalent vaccine (Easy five- TT) (Each Vial of 0.5 ml contains I dose)" has been exmincd and DoFr is requested to s.ct infmarion from thc lim on following points:. L Potency ofP.rlush Bulk in temsof OU/lU 2. Ponion of Batch Producrion Record showing dispensing, use ond reconcilaalion ofPerlush Bulk. I Detaih of items southr to be ifrponcd dlty fr.€ under the authorialion s 5 impon inputs e mention€d in point 16, Part B of ANF 4A wher.ss only 03 impon inputs arc m.ntioncd at poini I (a) ofAppendix I L Kindv acknovJledge the receipt. Nirin Kuma.r JanV Rfi-n glsR iia Scientisr "E '/ taIFiS '$ Deparhrnr of Bidcchnology / jt.Iqt{I}Flifr fu3{r{ Minisry of scicNe & Technology/ fom at* utdFlift airr*+ Block 2,6-8!h Floor$r;afl?E.2. GE dB-6L c.c.o. cromplex/ {f*3i.5rtq&fi Lodi Road. Ne\x Dethi-I l0003i / AIA rlg.;refrF -IIOOO3 03‐ 03‐2016 レ

⌒ Subject /ア Governmenl of lndia Minislry of Chemicals and Ferlilizers Department ot Chemicals and Petrochemic€ls 0.メんク『 Advance Aulholzalon applca“ on fron M′s Yasho industles Pvl ud rtr the import of matena:s againstthe expoft of BuTYLATED HYDROXY ANISOLE(BHA)etc The applications has been exsmined and lhe Departmenl recommends the lottowing norms for the present This issues with the approval of compelent authorily Advance Aulhorization applications. Autholzation No 0310748002 deted 24 12 201 1 1tem o子は,oft Qty llem of lmpori Oty BUTYLATED HYDROXY ANISOLE(BHA) l k9 ` HYDR00UINONE 01247K9 2 TERTIARY BUTANOL 0339k9 3 PHOSPHORIC ACID 100k9 4 HEXANE 1 00 ko nce Autholzaton No 0310795524 dated 24 4 201 l llem of ExpOn 01y Item of lmporl Qty Aromatic derivalive of diphenylamine(ADA) l k9 l DIPHENYLAMINE 0447 K9 2 ALPHA METHYL STYRENE 4230k0 3 ACTIVATED CLAY 0200k9 lAdvance Autholzation No 0310798585 dated 31 8 2015) Autholzation No o01o798289 dated 2o 8 201

ltem of Export Oly Qty YANT 0 2020(20% SOLUT10N OF TERTIARY BUTYL HYDROQUINONE) k0 ' HYDROQulNONE 0232 K0 2 TERTIARY BUTANOL 0208 k9 3 PROPYLENE GLYCOL 0700 k9 No 0310799241 dated 6102015 ltem Of ExpOn Qty llem of lmpon Oty YANT 0 3030 B(30・/.SOLUT10N OF TERTIARY BUTYL HYDROQUINONE) l kg ` HYOR00UINONE 0423 Kg 2 TERTIARY BUTANOL 0312 k9 3 PROPYLENE OLYCOL 0700 k0 lA K ACANWAL) Addi industlal Adviser Te, No 011_2338,430 Deptr. ofc&pc u.o tto r+btorssi2oll dated 231,2015 B

,,"xfuTr{ Ir. No.l50 I 1 /570/10l 5-PI (Norms) ( iolernnrcnl ol- lndia Nlinistr') of( hcnrical & Irenilizcrs [)cpaltnrcrrt o1 l'harnraccuticats Nc、Dclhi thc I d()! l]l)a\ir). I)ecernber'. l(J l5 ( )l llcc Mcnlonrduul SLrblcct: - lriration of nornrs under pam 1.7 of lland Book ol Procedures (Vol.l) ]0()ql.l ( ase . of M/s Vision l)rug I)'l Ltd. l'he undersigned is directcd lo rclir Io D(;IrT U.O.No. 0l /tl2l50/692/AM- I 6/ Dl.-S-1i656 dated thc 29l07l15 vidc rvhich application f'ronl M/s. Vision Drug Plt l-ld was senl lo this DcpanDrent ibr tixation of rornrs under para: 4.7 for thc c\po( of llomovcratronitrils. 'Ihis departmenl has e\amincd lhe nlatter and it is rcquested tlrat DGI:T nray call follorving tcchnical dclails liorrl lhc llrnr \i7:- (a) End-use ol thc e\pofl product. (b) Complete and balanced chcnical reaclions showing % y"ield on nrolar basis. ntrlar requirement ol each inpul. (c) Requiremenl and rccoverv ofSolvents. (d) Past production vis-ii-vis n ctual consunrplion oI all imponcd inputs dulJ cerrilied by Central Excisc Authoritics. 2. fhis issucs with the approval ol cornpeteft authoril). (Riri Kuntir) lrr]dcr Secrctary to the Go\ cnrntr'nl ol lndix Phonc:ll07l I (rl l)ir'ectoratc General of li,r'eiSn l_radc. I)elaltnrcrlt ol ( onnnercc. (Shd M.V. Sineh. F l DO). I dlog llhasan. Nes l)elhi

^ $ t. No.l50l l/484/2015-PI (Norms) Coverflment oflndia Ministrl' of Chemical & Fertilizers Department of Pharmaceuticals Udyog Bhawan. New Delhi. the November. 2015 Oll'ice Memomndum Suhiect: - Fixation ofnorms under para 4_7 ofHand Book ofprocedures (Vol.l) 2009-14 Case of M/s Mylan Labs Ltd. l he undersigned is direcred ro refer to DGFT U.O.No. 0l/8215 Ot533lAM-t6/DES-31517 dated thc li/07/15 vide which application from M/s. Mylan Labs Ltd was sent to this Department for fixation of norms under p at 4.'i fot the export of Tolmctin Sodium Dihydratc. This department has examined the mafter and it is requested that DCF.T may call loll,,n inE technical details from rhe firm r iz:- (a) Complete technical details as per Appendix-33 showing Mol.wl., oZ yield on moler basis and Solvenl Recovery etc. (b) Past producrion vis-d-vis Actual consumption of all imported inpurs duly certified by Central Excise Authorities. 2. l his issues with the approval ofcompetent authority. (Raj Kumar) Under Secretary lo thc (;ovemment oflndia l,hone:2307t162 Directomle (ieneral of L-oreign l-rade. Dcpartment of Commerce. (Shri M.V. Sinsh, Fl DO), Udyog Bhawan, New Delhi

^ ９一 UdYog Bhawan, New Delhi. the l2'h March,20l3 Office Memorandum

Subject:- Fixation of norms under para 4-7 of Hand Book of Procedures (Vol'l)

2009-14 Case of M/s. Granules India Ltd. The undersigned is directed to refer to DGFT U O No' Ol/E2/50/686/AM|3/DES-3/825 dated the O4/l0l'12 vide which an application liom M/s. Granules tndia Ltd was sent to this Department for fixation of norms under para: 4.7 for the exPort of Compresso Cotrim 90(Sulfamethoxazole and Trimethoprim Granules DC). This department has examined the matter and the Ibltowing comments are fumished under para 4 7 of Hand Book of Procedures (Vol.l) 2009- 14:- l. DGF'I may call Copy of Master-Balch formula duly authenticated by Quality-Control lncharge. 3. l'his issues with the approval ofDirector (Cost). F. No.3501 l/669/2012-Pl (Norms) Govemment of lndia Ministry of Chemical & Fertilizers 1vtr g,N0 (N.N.Ahuja) Section Officer PI-Norms Directorate General of Foreign Trade, Depaftmcnt of Commerce, (Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi.

´ -,( ^"''2 Government of lndia Sublect Advance AuthoHzalon apphcatton from M′ s Navin F uo“ ne intema“ona Pvt Ltd,for the import of raw matettal againstthe export of 2-Fluoro 6 Trifluoro Methyl Pyridine (Advance Authorzation No 0310793706 dated 09 02 2015) Ref U O No 01′ 82′50′270′AM-16/DES‐ ‖/350 dated 03 07 2015 M/s Navin Fluorine internat onal Pvt Ltd have submitted present applcation for the mport ofraw material againstthe export of 2‐ Fluoro 6 TrinuOrO MethyI Pyridine The app‖ cation has been examined and the Department recommends the following norms forthe present Advance Author zation applicat on

ltem of Export Qty Item of lmport Qty 2- Fluoro 6 Trifluoro Methyl Pyridine l kg 2 Chloro 6 Trichloro Methyl Pyridine 200 kg This issue with the approval of competent authority. (A K ACARWAL) Addl lndust「ial Adviser Tel No 011-23381430 Ma n Deptt of C&PCU O No 14010′ 92/2011‐ CH‐ il dated 8022016

ヘル 9″ ′呵| Government of India Subject: Advance AuthoHza“ on app‖ calon from M′ s New Alance Dye‐ Chem Pvt Ltd,for the import of raw matenal against the export of NTA TRISODlUM POWDER (TRISODIUM NITRILOTRIACETATE)INTA PCIWDERI (Advance Autho「zation No 0310792689 dated 08 1 2015) Rer uO No 04′ 82′050/262/AM‐ 16,181 dated 29 6 2015 M/s NewA‖ance Dye―Chem Pvt Ltd have submitted present app‖ cauon fOr the import of raw matenal aga nst the export of EDTA TRISODlUM TRIHYDRATE(TRISODIUM EDTA TRIHYDRATE) The app cation has been examined and the Department recommends the fo‖ owing no「ms for the present Advance Autho「zation application This issues with the approval of competent authority. (A K AGARWAL) AddL industr al Adviser Tel No 011-23381430 Sh百Mahender Vikram S n●h FTDO(DES■ )0/o DGFT Udvoq Bhawan New Deh-11 Deptt Of C&PC U O No 14010′ 13′2012‐CH‐ ‖dated 5 10 2015

ltem of ExDort Qtv Item of lmport Qty NTA TRISODlUM POWDER (TRiSODIUM NITRILOTRIACETATE)INTA POWDERl l kg l NITR:LO TRIACETIC AC,D(NTA ACID) 0 771 kg ′ ,yr`RII:1:こてこ ´

― F No 14010′ 55′2012‐ CH‐ 11 Government oflnd a Dep淵:P∬』器留ξ謂霧」鳳i酬s g´ Shasttt BhaVan,NeW Delhl l10001 Dated1 28いOaOber.2015 To, M/s. Anthea Atomalics h/t Ltd'' R-82, T.T.C. lndustrial Area, Rabale M l.D.C. Navi Mumbai, Maharashtra-400701 Subject; Advance Authorization Application for the import of raw-malerials against the export of LILIVOL iiar"nct l,tnoti'"tion No' 03'10792911 dated 14'l'2015) Please refer to your Advance Authoazation application received throughOffice of DGFT on the subiecl mentioned "oou"' 'in -iii" "o'"i'"aion you are requested to submit the ioiiorin-rilnio-"tio" *ithin 15 davs of the issue of lhis letter' 'l Detailed manufacturing process with balanced chemical reactions indicating number of 'o'"" ii 5r'ih"- t"iitants' produas and. by-products with conesponding'o'"J'r"i"roit'i"'-itructur;l formula' molecutar weight and process flow diagramoe vield with respect of each of the reactants and 2. Stage-wise Perc€nt products and tn" '"iJ'-'tiil'istn"ttion;nclosing.therewith authentic pnnted iechnical literature rn support of yield/ quant(y of items for import 3. Details of byprodua"'ioli"i a'itng tni proclss and recovery of solvents in terms of quantity and value' 4. Details ot proauaio-n JiEport product under reference.and conesponding consumptionorrau,'iiatela-r'i'itheyear2014-15.and20'15-16(Apnlto September) oury certrriJ'ov be may b; fumished lf the produclion has not commenced in tne pasi' t'! detailsirom commencement oI production may be furnished duly certified bY CA' 5. Any other relevant information' ifany' Yours faithfullY, (A K ACARWAL) Addl industrial AdviSer TcI No 011-23381430 DGFT/UONo‐ Copv tO: Sh“ Mahender Vikram S ngh,FTDO(DES-3).in referenCe to 01′ 82′ 050′ 199′ AM‐ 16′DES‐ 3′606,Dated 15 07 2015 へ鰤 ,

Government ofindia Dep酬‖器♂ `溜闇ζ謂遭悶鳳1酬s “ SubleCt Advance AuthOnza10n applcatiOn from M′ S SHRI BAKEY BEHARI LAL BOAD MILLS fOrthe impOrt ofraw matena s againStthe export Of THYMOL 99%PURE &ABOVE (AdVance AuthOriZation No 0510392953 dated 21 1 2015) Ref:UO No 01′82′ 050′ 16′AM16′ DES―‖ |′349 dated 3 07 2015 ユμ い (A,K, AGAR^INAL) Addl lndustnal Adviser Tel No 011‐23381430 M′s SHRI BAKEY BEHARI LAL BOAD MlLLS haS Submitted preSent app‖ catiOns fOr the import of raw matenals againstthe export of THYMOL 99%PURE&ABOVE normSIliξ ]l!::‖:λ」ι:l」:i:ltf::」:Waind the Department reCOmmends the fo‖ OWing ,plicatiOn ヽヽヽぐ Item of lmPort ― E9850/o … URE&ABOVE This issues with the approvat of competent authority I Ma r h FTDO (DES― ‖ Deptt Of C&PC uO No MO10t28 12012 -CH-ll Oatea SO.g.ZOtS ^

Government of lndia Ministry of Chemicals and Fertitizers Department of Chemicals and petrochemicals Sublecl: Advance Authorレalon applca“ 。n frOm M′s vDH Organ cs Pvt Ltd fOrthe impOrt ofraw mate“ al againstthe export Thymol Crystal(3-HydrOxy P‐cymene) Rer Uo No 01/82/050′01288′ AM-16/DES‐ 3′1263 dated 16 12 2015 UO No 01′ 82′ 050′01266/AM_16′DES‐ 3/1222 dated 15 12 2015 UO No 01′82/050′01288′ AM-16/DES-3/1263 dated 15 12 2015 UO No 01′82/050/01485/AM-15′ DES-37 dated 14 2 2015 M′S VDH Organics Pvt Ltd have submitted present app“ caいon for the impOrt of raw mateHai againstthe export of Thymol crystal(3‐ Hydroxy_P_cymene) The app‖ catiOn has been examined alic」 ]:1:epartment recommends the fo‖ owing norms forthe present Advance Autho「zation apl 15122014) 2712015) 9102015) 1492015) 群棚Ь C嗚J13 Hydroxy P Meta Cresols (M-Cresol) This issue with the approvat of competent authority. ヽ Add愉詰ぜ }:含酬:『 Tel No 011_3381430 ri l\rahender Vikram FT U Deptt. ot C&eC U.o. t'.lo 14010/53/2010 dated 16 22016 八

八 F No 35011/653/2015-Pl (Norms) Government of lndia Minrstry of Chemical & Fertilizers Departnrent of Pharmaceuticals Udyog Bhawan New Delh Daled: 1 February 20'16 Offrce IMemorandum I Sub: Frxation of norms under para 4 7 of Hand Book of Procedures (Vol l) 2009-14. Application of M/s Hemmo Pharmaceuticals Pvt. Ltd The undersigned rs directed to refer to DGFT U O No 01/82/050/00934/AM 16/DES-3/903 dated the 08/09/2015 vide which an applicatron from M/s Hemmo Pharmaceuticals Pvt Ltd. was forwarded to this Department for fixation of norms for the export of Desmopressin. This department has examined the Export product is Desmopressin DGFT is advised to call production vis-a-vis actual consumption of all inputs duly certifred by Central Excise Authorities for the year 2014-15 and 2015-20'16 2 This issues wlth the approval of competenl authonty Under Secretary to the Government of lndra Phone: 23071162 Directorate General of Foreign Trade Department of Commerce (Shri MVSingh, FTDO) Udyog Bhawan, New Delhr

Government of lndia Department of Chemidals and Petrochemicals Subjecl: Advance Authorization application from M/s. Navin Fluorine lntemational Pvt. Ltd., for the import of raw material against the export of Fluoro Benzene. (Advance Authorization No. 0310793706 dated 09.02.20't5) Ref: U.O. No. 01la2lsol48r'.lAM-16|DES-Illi388 dated 07.07.2015 M/s. Navin Fluorine lntemational Pvt. Ltd. have submitted present application tor the import of raw material against the export of Fluoro Benzene. The application has been examined based on the additional information furnished by the firm. lt is indic,ted by the firm thal they are importing Fluoro Benzne in small packing of 200 kgs drums and exporting the same after adopting the procedure of distillation and filtration in ISO Tanks. The wastage applied is 2olo. Department recommends the following norms for the present Advance Authorization application.

ltem of Export Qty Item of lmport Qty Fluoro Benzene l kg 1 Fluoro Benzene 102 kg This issue with the approval of competent authority. 体K聴 Addl industrial Adviser Tel No 041‐23381430 し/´ Shr Mahender Ⅵkram 3nohFTDOイDESJ‖ )0/o DGF■Udvoo BhawanNew Ddh-1■ Deptt of C8PC U O No 14010/92′ 2011-CH‐ 11 dated 8 02 2016 ,

ノ′ 一 Subjecti Ret uO No M′s New Alance mater al against TRlHYDRATE) Advance Autho12a"On apphcalon f「om M′s New A‖ ance Dye‐Chem Pvt Ltd,for the import ofraw matenal aga nstthe export of EDTA TRISODIUM TRIHYDRATE (TRISODIUM EDTA TRlHYDRATE) (Advance Authorization No 0310793791 dated l1 02 2015) 01′ 82′0507488/AM-10′ DES‐ 1‖′465 dated 07 07 2015 Dye― Chem Pvt Ltd have submitted present app‖ cation for the import of raw the export of EDTA TRISODlUM TRIHYDRATE(TRISODIUM EDTA Government of lndia iilinistry of Chemicals and Fertilizers ンスノ 0 う0 Addl lndust百a:Adviser Tel No 011‐23381430 The application has been examined and the Department recommends the following norms for the present Advance Authorization application' This issues with the approval of competent authority' Item of lm l ETHYLENE DIAMINE TETRA ACETIC ACID(EDTA) EEITA TRISODlUM TRIHYDRATE (TRlSODlUM EDTA TRIHYDRAT 冬ヾ (AK AGバRWAL) M beptt of C&PCu O No 14010′ 13′2012‐CH‐ ‖dated 5102015 |

ハ Ir. No.l50l l/178/2015-PI (Norms) (;overnment of India Ministr) oi Chemical & FertiliT-ers Department o f Pharmacc uticals Oflice Memorandum Subiect: - Fixalion of norms under para 4.7 of Hand Book ol Procedures (Vol.l) 2009- 14 Case olM/s Ranbaxy Labs l-td. The undersigned is directed to referto DGFT U.O.No 0l/8215013721AM'I0IDES-3I456 datcd the 0?/07/15 vidc which application from M/s. Ranbaxy Labs Ltd was sent to this Dcpitflment tbr lixalion of norms under para: 4.7 for the expo( of Vrlacyclovir/Vsleciclovir hcL tablets/Capsules. fhis department has examined the matter and it is requested that DGFT may call copy ofvalid DML lbr the expofl product. 2- This issues with the approval ofcompetent authority. Dircclorate Ceneral of Foreign Trade. Departmcnt of Commerce. (Shri M.V. Singh. FTDO), tJdyog Bhawan. New Delhi Ncw Dclhi、thc Udlog Bhawan. December. 2015 (Rai Kumar) Under Sccretary to the Govemmenl oflndia Phone:23071 162

F No 35011′ 216′2015-PI(No「ms) Government oflndia Min stry of Chemica s&Fert‖ zers Department of Pharmaceut cals Quantity allowed for e で万ル「 ´ 7ノ3 Shastri Bhawan,New Delhi, Dated the February 10 2016 Off ice Memorandum Subject. - Fixation of norms under pa? 4.7 of Hand Book of Procedures about request ol l.4/s Encube Ethicals Pvt. Ltd , l.4umbai The undersigned is directed to refer to DGFT U O.No. 01/82l050/566/AM- 16/DES-3/240 dated the 30/06/2015 vide which application from M/s Encube Ethicals Pvt. Ltd . fumbat was sent to this Department for flxation of norms under pa? 47 'fot the export of (1) Fusidic Acid 2'/o and Betamethasone Valerate 0.01 % Cream '15 Gms. Tube (2) Fusidic Acid 2'/o and Betamethasone Valerate 0.01 % Cream 30 Gms (3) Fusidic Acid 2 % and Betamethasone Valerate 0.01 % cream 60 Gms' This department has examrned the mafter and following norms are furnished.- 5 Raw Materials Betamethasone Valerate Micronized Cetoslearyl Alcohol Fusidic Acid Micronized Liquid ParaffinAハ′hite minera1 0‖ Macrogol Cetostearyl Ether tAVhte Soft Paraffin Empty A um num Tubes ′q9η ′υb9_ 0 01857 gm 108009■_ 030609m __ 0 9000 gm 0 2700 gm 2 2500 gm ___ Relevant and pOLy 30gm′υle 0 0374 gm 21o009m_ pO上⊇9m _ 1 8000 gm 0 5400 gm ach 6りm′υb9_ 007439m `二 290g甲_ 1 2240 gr _ 360009m 1 0800 gm 9 00pO g吐 as per packing 一一一　　．＾一一一一一一一一一二 4 5OOO gm may be allowed ＾Ｚ Under Secretary to the Government of lndaa Phone - 23071162 Directorate General of Foreiqn Trade, Department of Commerce, (Shri [I V Singh FTDO). Udyog Bhawan, New Delhi

F. No.350l I /582/2013-PI (Norms) Govemment of India Ministry of Chemical & Fertilizers UdYog Bhawan, New Delhi, the 24'h December, 2013 Office Memorandum Subjcct: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s Eurolil'e Healthcare Pvt Ltd. l-he undersigned is directed to rel'er to DGFT U O.No. 0l/82/50/323/AM I 4/DES-31377 dated the 08/08/13 vide which application from M/s. Eurolift Healthcare P\t Ltd was sent to this Department for fixation of nnrms under para: 4.7 for the export oi Metronidazole lntraveous Infusion l00ml and Metmnidazote 500mg. This department has examined the matter and thc lbllowing norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009- l4:- DGF-1 may call Drug Manulacturing l.icense (DMI-) for thc exort itcm. l his issues with the approval ofDirector (Cost). (Raj Kumar) Under Secretary to the Govemment of India Pl-Norms Directoratc (;eneral of Foreign Trade, Dcpanment of Commercc, (Shri R.C. Meena, Dy. DGF I-), Udyog Bhawan. New Delhi.

td)>.' at4 Govemment of lndia 9'4 Deparlment of Chemicals and Petrochemicals Sublect:Advance Authorzalon app ca」on from M′s S M Chem cals Ltd forthe import ofraw matenal againstthe export of Tns(Tndecy)PhOsphte Ref: UO No 01′82/50′0935′AM-46′DES‐ ‖′958 dated 10 o9 2015 (Advance Authorzation No 0310795271 dated 31 03 2015) M/s. S.M. Chemicals. Ltd. has submitted present application for the import of raw material against the export Tris (Tridecyl) Phosphite. The application has been examined and the Department recommends the following norms for the present Advance Authorization application.

ltem of Export Qty Item of lmport Qty Tris (Tridecyl) Phosphite l k9 4 Phenol 0 0558 kg 2 T「idecvI AIcohol(T「idecano) 0 9750 kg
Phosphorus Trichloride 0 2290 kg This issue with the approval of competent aulhority. 体K楊 Addl industria:Adviser Tel No 0112338 1430 m h FTDO rDESJI Deptt of C&PCU O No 14010/64′2010‐CH i dated 8 02 2016 ew Delh-11

ノ F No 14010′ 9′2016‐CH‐ ‖ Government ofind a Ministry Of Chemicals and Fert‖izers Department of Chemicals and Pet「ochemicais Shastri Bhavan, New Delhi-1'10001 Dated: 116 February, 2016 To, M/s. Dr. Acharya Laboratoreis Pvt. Ltd. B-21 1, Jawahar Darshan, Shrikhande, Wadi, Manpada Road, Dombivli-East. 421201.

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

ol Came Crude/Methyl-2-amino-lChloro Benzoate. (Advance Authorization No 0310795534 daled 24.M.2015) I am direcled to refer to your Advance Authorization application received through Offlce ot DGFT on the subject mentioned above. ln this connec{ion, you are requested to submil the following information within 15 days of the issue of this letter. ，一　（６ Detailed manufacluring process, material balance with balanced chemical reactions indicating stage-wise percentage yield along with the technical justification enclosing therewith authentic printed technical literature in support of yield or quantity of items for import. What is the basis of applied quantity of raw materials against the export product. You have indicated the details of production and consumPtion in the past 3 years as nil. The Details of production of Came Crude/Methyl-2-amino-3-Chloro Benzoate and corresponding consumption of raw materials in the year 2015-'16 (April to December) duly certified by CA may be furnished. lf the production has not commenced in the past, the details from commencement of produclion may be fumished duly certifled by CA Any other relevant inrormation Yours faithfully, AddL lndustr al Advise「 Tel No 011‐23381430 4 艶覺ィ糟鵬;:『群 I器殿♀ll』:明t£ ETな」ち朧「 nce b DGFフUO No‐

tr

o./o'l?{ f. No.l50l I '176120 I 2-Pl (\orms) Govemmenl of lndia Ministry ofChemical & Fertilizers Udyog Bhawan, New Delhi. the 0l"tApril. 2014 Ollice Memorandum Sub.ject: - |ixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case of M/s R A Chem Pharma Ltd. The undersigned is dirccted to reler 1() DGF'l U.O.No. 0I /82/50/009.1 460. i 554/AM- l-1.12.08,/l)lis-3i l l98 dated thc 29/0 1/ 14 vide which application tiom M/s. R AChem Pharma l.ld !as scnl Io this Departmenl for lixation of norms under para: 4.7 tbr lhc export ol' Entacapone. This department has examined the malter and the lbllowing norms are furnished undcr pam 4.7 oflland Book ofProcedures (Vol.l) 2009-14:- S No. Impon ltcm Qly. Recommended kg,&8. 1 Vaili n 2306 'vridinc 102 J DicthvI Aillinc :437 4 lolucne l. i5 5. 6 \4clharo1 0.61 Ethvl Acct.ltc 2.56 This issues with lhe approval of Director (Cosl). (Barnali Khastgir) Under Secretary to the Covernment oflndia pl-Norms I)irectorate (icneral of Foreign Trade. I)epartmcnt o{-Commercc, (Shri I{.C. Mcena. Dy. DGFT). tldlog Bhawan. Ne\, t)elhi 寸寸 ■ Ⅲ l 一　一

F. No.3501 1/648/20'15-Pl (Norms) Government of lndia Ministry of Chemical & Fertrlizers Departnlent of Pharmaceuticals Udyog Bhawan, New Delh , Dated: 21 january 2016 Office Memorandum Sub: Fixation of norms under para 4 7 of Hand Book of procedures (Vol.t) 2009-14 Application of M/s Granules lndia Ltd The undersigned is directed to refer to DGFT U O No 0'1/82/050i874/AM 16/DES-3/864 dated the 02109/2015 vide which an apptrcarion from M/s Granules lndia Ltd was forwarded to this Department for fixation of norrns for ths qlpert of (2 S,5 R )-5- F tuorocytosine- 1-yL-[1 3]-Oxathiotane-2-Carboxytic Acid l\renlhyl Ester (FCE) Thrs department has examined the Export product rs FCME (MolM 399) where as the chemrstry is given for FCE (Mot.wt 3Bi). Retevant chemisky and yields etc may be lurnished as per appendix-33. 2 This issues with the approvat of competent authority (Rajkumar) Under Secretary to the Government of lndta Phoner 23071162 Directorate General of Foreign Trade Department of Commerce, (Shri Nl V Singh, FTDO). Udyog Bhawan, New Delhi

^ f . No.i50l I 168 l/20 l5-l'l (Nonns) Crrvclrrrrcnt ol lndia Ministr] ol-( henticals & Feflilire15 l)cparlnrent ol l)hannaceuticals 18 ----' e/' lql4 Ud)09 llha\rn.Ner\ l)c lh i. Dated: I |ebrnar. l{)16 Olll(. \l.rorirn(lunr Subiecl: |i\alion ol-nornr\ undcr parr -1.7 of Hand Book ol l)rocedures (Vol.l) 1009-11 ( asc ol M/s Srini Phannaceulienls l-td. 'lhc undersigncd i\ dircclcd 1() rclcr ro l)CliT (l.O.No. 0l/82/50/1165/AN1- l6i DI:S- ,1/91{ daled the 8/9/15 !idc \hich applici(ion tioDr M/s Srini Pharnraccoticals Ltd. \irs \crrl o lhis l)epannlent tbr ti\llion ol n(nra\ undcr para: .1.7 lbr the c\port ol l\l\c('d)coolirrc Moletil. This dcpannrcol hirs c\0rninrd lhe tialtcr and thc fbllorring nonns are lirflti\h.d undcr pom ,1.7 of l land lkx)k ol-llroccdufcs (Vol.l) 2009- 14:- Nofnr\ Ilc.('nrnren{lerl N4\cophenolic rci(l for lkgt\porl 0.94lLg Nlctharrol l his issues rvith thc xplrr)'nl ol !t)nrpclenl aulhorit. し 'nticr Sccrctar、 lo I lllg t.{)5k3 (liajkumar) lhe Go!ernment ol lnd ii Phone:13071 l6l l)irccto|utc (;cncral ol_lirrrign I racle. I)eprfl nrcnt of ( onrnrctte. (Shri Nl.V. Singh. lrf DO). Lld)tlg Ilha!an. Ncw I)e1h i lnrporl llrrlr

^ 肛一け ´ ´ ` (lkikUrrtlr) Ci0vernnrent ()l- ln(li.t l'h(nre:ll07l l(,1 I:. No.3i0l 1165 l/20t 5-Pl (Nornrs) Colcnrnrcnt ol Indiit MiDistr'\ ot ( hcmicals & Fcnilizcrs I )epal1nreIl ol l'harnracfl rticals Lldlog llha\an.Ne\ l)elhi. l)lled: I Fcbrua^. lol6 o L11r!Vb!\4!!lu!l Subiccl: - tii\alion ol-nomrs under parr .1.7 ol Hand Book of Pr()ccdures (Vol.l) lo()t)-l-l C ase of M/s Aurohindo l,harnlr Lld. Thc undersiglcd i: directcd to r!lar to i)CFl Ll.O.No.0l/82i50/00817/Al\l-I6/Dl:S- l/861i dated thc l/09/15 vide !\hich appliciilion trom M/s. Aurobindo Phanna Ltd. \as scnr ri, this l)epartrncnl fi)r lixuti( ot noni\ uldcr para: ,1.7 lbr the cxpon of l)oxitzo\in Mcsilfltc. l his dcplnrncnl has csanrirred lhc rtrilttcl' aod the tbllowi'rg nornt\ arc tilrnished undcr prril {.7 ol lllnd Book ol-P()ccdrrcs(Vol.l) 1009- 14:- Nor1n\ Rcc(irnnrcrl(ic(l ||ヽ1、 |)11ヾt11、llt)111:1ll tC Tctra ll、drolt an ♪ | う I his issucs \ ilh thc irpl)r()\ ill ofe(,rnpctcnl aLrlhorit. [ ]r)(lcr Sc!rc(nr\ lLi lhc I)ir'ceto|ntc (icneral ol'[orcigr] I mdc. l)cpallIrer]t ol_( (nnntcrcc. lShri lvl.V. Singh. l'l l)O). Lrd),og lJharan. Ne\ l)ellr i lrnpon ll.nr l -l (2.3-Dihl drrr l..l-benzc,Ji,,xr,n-ll Yl-)carbon) I lpiperuine l-Chloro-6.7-l)inrclho\ -:l-Quinarolioc Anrinc

ン ″ _ 肺謂柵]∴T亀嗣"sコ。「だ7 Sublecl:Advance Authonzalon appicalon from M′ s Sebacic lnd a P Ltd forthe import ofraw mater al againstthe export oF Sebacic Acid (Advance Autho口zation No 3410041253 dated 28 05 2045) Refi UO No 01′82/050′00932/AM16′ DES―‖1/959 dated 40 09 2015 M′s Sebacic india P Ltd has submitted p「 esent application forthe import of raw mater al againstthe export of Sebacic Acid The app‖ cation has been examined and the Department「ecommends the fo‖ owing norms forthe present Advance Autho「izat on app cation

ltem of Export Qty Item of lmport Qty Sebacic Acld l kg '1. Caustic Soda 1 40 kg
2-Ethyl Hexanoic Acid 0 10 kg Thjs issue with the approval of competent authority. 体隋 Add「Industrial Adviser Tel No 011‐23381430 ES― Deptt Of c&Pc No. 1401019/201 5-CH-ll dated I LO22016

Government of lndia Sublect Advance Authottza"on app‖ calon from M′s S M Chem cals Ltd forthe import ofraw material against the export of Dilsodecyl pheny:Phosph te(DDPP)and 2-Ethyl HexyI Diphenyl Phosph te Rer uO No 01′ 82′50/782′AM-16′DES‐ ‖1/696 dated 31 7 2015 U O No 01′ 82/50/718′AM‐ 16′DES‐ ‖/699 dated 31 7 2015 M/s SM Chemicals Ltd have submitled present applcanon fOr the import of raw mate面 al against the exPort of Di lsodecyi phenyl Phosphite (DDPP)and 2‐ Ethyl Hexyl DiphenyI Phosphite The apprcatiOn has been examined and the Department recommends the fo‖ owing norms fo「 the present Advance Autho「ization applcation Authorizaton No 0310796577 dated l1 62015

ltem of Export Qtv Item of lmport Qtv Dilsodecyl pheny: Phosph"e(DDPP) l kg l Phenol 0231 kg 2 lso Decyl Alcohol 0 734 kq
Yellow Phosphorus 0 075 kg nce Authorzaton No 0310796312 dated 29 5 201
ltem of Export Qty Item of lmport Qty 2 ‐EthyI Hexyl Diphenyl Phosphne l kg l Phenol 0 604kg
Yellow Phosphorus 00 966 ko
2-Ethyl hexanol 0 386 kg (A K AGARWAL) Add「Industrial Adviser Tei No 011-23381430 Deptt Of C&PC …No 14010′64/2010-CH‐ H dated 8 10 2015 hr DG FT

P F No 35011/648/2015-Pl (Norms) --- .l.l Covernment ot tndra 9 ,r" )O I Mrnistry of Chemical & Fertilizers Udyog Bhawan, New Delhi Dated 21 january.20'16 QIrqe- l4erlsrald-ull Sub Fixation of norms under para 4 7 of Hand Book of Procedures (Vol l) 2009-14. Application of M/s Granules lndra Ltd The undersigned is directed to refer to DGFT U.O No 01/82/050/855/AM16/DES-3/859 dared the 01/09/20'15 vide which an apptication from M/s Granules lndia Ltd. was forwarded to this Department for fixation of norms for the export of (2 R-Cls)-2-Hydroxymethyt-5(5-Fluorcytosrne- T - YL)-(1 ,3)Oxathiolane EMS-ll This department has examined the matter and the following norms are recommended against this application - lmport (em (rS,5R)-5-Fluorocytosine 1 YL-[1,3]- Oxathiolane-2-Carboxylic Acid Menthyl Ester Norms Recommended for 1!g Export 1726k9 This issues with the approval of competent authority (Ratkumar) Under Secretary to the Government of lndta Phone 23071162 Directorate General of Foreiqn Trade Department of Commerce. (Shri MVSingh,FTDO), Udyog Bhawan, New Delhi 一〇一Ｎ　　ｌＳ L6qE) Sod)um Borohydrade ~~T「「「「 |~~~d′&9 ~ ~

F No 35011/648′ 2015-PI(No「ms) Government oflndia Ministry of Chemical&Fert‖ zers Department Of Pharmaceulcals | 一９一９０ｋ一一　．．．．．．一一一一 ― 「 Udyog Bhawan, New Delhr Dated: 21 january 2016 Office Memorandum Sub: Fixation of norms under para 4 7 of Hand Book of procedures (Vol.l) 2OO9-14, Application of M/s Granules lndia Ltd The understgned is directed to refer to DGFT U O No. 01/82l050/864/Al\i116lDES-3/857 dated the 01109/2015 vide which an apptication from M/s Granules lndia Ltd. was forwarded to this Department for fixation'of norms for the export of Sofosbuvir. This department has examined the matter and the following norms are recommended against this application:_ lmporl tenl No「ms Recommended fo「 lkg ExpO“ 1 92kg N((S)(23456‐ Penta刊uoro PheバOxv) noxy) Phenoxy Phosphrnyl)-L-A anrne-i -Meihyl 12R)?LDqOxy′ FDお2 1vllhylI面」吊『 : 2 This issues with the approvat oi competenl authority Under seαdaりoぃe Govemm』酔躙: PhOnei 23071162 :[::躍i■Ⅷfttdgn.adQ (Shn M V Sngh FTDO) Udy09 Bhawan New Delい ,S No 1 1

´ ′ニ ′ ハん 1ヤ Addl industHal Adv ser Tel No 011-23381430 Government of lndia Sublect: Advance Autho百zauon app‖ ca"on from M/s Etemis Fine Chemicals Ltd for the import of raw matenal againstthe export of 3‐ Methy卜3‐ Penten‐ 2‐One/Methyl Penten one (AdvanceAuthorizatonNo 0310796567datedl1062015) Ref:UO No 01′82′0507001253/AM-16′ DES‐ 3′1380 dated 21 12 2015 M′s Etemis lne chemicals Ltd have subm tted present app“ cation for the mport of raw matenal againstthe export of 3‐ Methソ1‐3-Penten‐2 0ne/Methyl Penten one The app caton has been examined and the Department recommends the fo‖ owing norins forthe present Advance Authorizat on app cation

ltem of Export Qty Item of lmport Qty 3‐Methyl‐ 3‐Penten-2 0ne/Methyl Penten one l kg l Methyl Ethyl Ketone 1 065 kg This issue with the approval of competent authority 体Kズ聰憔 Deptt Of C&Pc No 14010/57/2015‐ CH lldated ll o2 2016

⌒ F No 35011′ 649′ 2015-PI(No「ms) Government ofindia Ministry Of Chemical&Fert‖ lzers 新 Udyog Bhawan, New Delhr Dated. 21 january 2016 Office Memorandum Sub: Fixation of norms under para 4 7 of Hand Book of Procedures (Vol l) 2009-14. Application of M/s Trimax Bioscrences Pvt. Ltd The undersrgned is directed to refer to DGFT U O No 01/821050/00852/AM 16/DES-3/91 1 dated the 08/09/2015 vide which an applicatron from M/s Trimax Biosciences Pvt. Ltd was forwarded to this Department for fixatron of norms for the export of Atorvastatrn Calcium. This department has examtned the matter and the following norms are recommended against this application:- 一０　　　　　　・Ｎ　　ｌ　　２Ｓ | lmport itenl 狙滉稚178裂殺,1:き選:MeW2 羅itti鍛〔肥柑° propy l l都躍J:°hl ■_T T Norms Recommended for 1kg Export 0708k9 0994k9 _2型く 9 5,31kg ３４一 2 (Rajkumar) Under Secretary to the Government of lnd a Phone 23071'162 D「ectorate Ceneral of Foreign Trade DepartmentOF Comme「ce (Sh面M V Sngh FTDO) udyog Bha、van Neヽv Delhi

Governmenl of lndia Department of Chemicals and petrochemicals /8 Sa /,{ /Ba/2q(, ?*z-- Subject: Advance Authorization application from M/s. VDH of raw material against the export Menthol (Advance Authorization No. 0510392987 dated (Advance Authorization No. 0510394805 dated (Advance Authorization No. 0510395542 dated (Advance Authorization No. 0510395716 dated Ref: Uo No 01′82′050′636/AM‐ 16/DES‐ 3/676 dated 30 7 2015 UO No 01/82/050701219′ AM-16/DES‐ 3′1309 dated 16 12 2015 UO No 01′82/050/01221/AM-16/DES-3/1308 dated 16 12 2015 M/s. VDH Organics pvt. Ltd. has submitted present application for the material against the export of Menthol. Organics Pvt Ltd fOr the import 27012015 01072015) 79 2015) 2392015) import of raw 〇〇 ⊂⊇n∝msぷ;ξ躍翼lll鳳ぶItぶ諷Fa::穐躯fepanmen ttcOmmends he ttЮ輛 ng ltem of ExpOrt Qty tem o,Import ユ Menthol l kg l Meta cresolabove 98 5%Pure 1 50 kg 2. lso Propyl Alcohol 1 80 kg, This issue with the approvat of compelent authority. &ffi-rx (A K, AGARWAL) T3l,lj1"l'tllisllli;;

ハ lr. \o.-1501 I 6lii/1015-l,l (Nonn) (io\ !rlrnre l ol htdiir \lini\tr) )l ( hcnrical\ & fcl,tili,,er
L)cpaf tnr!nr ol_ Ph6nracculierls Qlltr \lslrql.ld rl]] Subiecl: - Fi\ation ot nornrs Undef parir 1.7 ol'llaDd Book ('asc ol M/s lndo l'h\to Chcnrieals l,vt. l-ld. 'lhc undeEitned i\ direcled lo retcr ro I)Cl- l U O.No. 0l :l/8(,0 datcd thc l/9/15 'ide !,hich appticrrion ljorn M/s tndo phltcr \cnl lo lhi\ Depaflmcnl l-or ll\ation ol-ni' n\ Lrndcr para: .1.7 lbr the Acctatc. lhis deparllncnl h.ls eraminctl thc otatter.and lhe tirllorr (ndcr para 4.7 of Hand IIx'k ol-Procedufc (Vol.l)2009-1.1:- S.No. ] tnlpo llcnr rl ll.r.,,rr.1lr, I r rl,,r.l.rr.r'-,..,..r..t,r..t,\t,- ...r,rrltr\t-t..- I)i,)\lIc . lrrr:rlr.Ii tr,rrr ― に ― 5 11ヽkt う I his issucs \ ith rh. irppfor itl ()le('rnpcicnt itulhoril
I)ircclofttc Ccnerill ot F()rljign Ir.rde. l)cpnr(nrcnt ol ( ontntcrc. (Shri NI.' Sin]rh. F llX)). trd_\og llhawan. No\ t)clh i Lldlog Uhar\an.Nc\ Delhi. Dated: I Februir_.lol6 ol Proccdures ( Vol.l) ltl09-l.l l [ ]nder Sccrctar\ lo thc /82/50/854/4 M- I 6./DLS- Chemicals P!1. l-1d. \ irs e\pon of Norelhislcrone 'ing norms are lurnished Nornts Rccomrn,:ndcJ lar lkS l-.\p(xl l..i{)8k-r l.l l5k:r

Ir. No.350l l/681/2015-Pl (NonDs) Co!cflnrcnt of lndia N{inistr} of( hernicals & Fertilizcrs Dcpannrent ol Pharrnaceuticals tld!og Bhawan.Nc\ ljclhi. llated: I rchruan. l0l6 Ofllce Nlenrorandunr Subiecl: - Fixation of n(nrrs under purir J.7 of Hand Book ol Procedures (Vol.l) 1009-1.1 Casc of M/s lndo l'hllo Chcnicals I'vl. I-td. 'lhe undcrsigncd is dirccrcd l{) rclar 1() I)Clr'l tl.(l.No. 0l/82/50/868/r\i\l l6/l)l:S l/869 daled thc 2/9/lj vid.,,,hich applicalior liom M/s lndo l'hyto (hemicals I',t. l-td. \tls scnl to this Department lor tl\alion ofnornrs under para: .1.7 tbr lhe expol1 ol Norethi\tcR,0c Bulk Drug. This depat'tnrenr has e)(anrinc.l the nrattcr and fhe lbllorving nollDS arc tirrrishcd uDder para 4.7 of Hand Book of Procedures (Vol.l) 2009- l4:- Norns Rccorrnrcn(icd l ctlah、d「。ltira) I his issucs \ illr ilrr appR)vnl ()l .r)nrpcten! xuthoril. li)r lkg I \f()rt 1 343kt 1 217kt 5 25ks llndcr Sccrclxfl lo the Covernmeft ol lndiu Phonc:ll(l7ll(rl Dirccb.ale Cenelal ()1' Foreign Tradc. [)epartrDcnl of Cornn]erce. (Shri M.V. Singh. lrl I)O). tld\og Bha\an. Nc\ l)cllri l-l.lorrc( D) ( hlorJkcl.(l-1.r'rh,, 1,tro|\ I r .'.'. j l inrcth\ I l. l 「ゞヽぎ:| Inrpofl Ilcnr

lr ().lj(ll l'6lt()/1015-l,l {N()rnrs) (,o!. nnlenl ol-lndia Mini\tr) ol ( hcmicals & |.rlilirel5 l)cplrlrrrrnl ('l l'hamracculicals Lld!0g Irhat\an.Nc\ I)clhi. I)atcd thc I Fcb,1un. l0li, Qlic! lU qtrqsrIlrll Subicc!: - Firution ol nornrs under paftr 1.7 of Hand Book ol Pr()cedurcs (Vol.l) ]()0()-ll ( asc ol Nlrs t)'. Iledd)\ l.aborrtoric\ Ltd. 'lhc undersirned is dircercd lo rc,crk) txiFt tl.O.No.0l/81/5()/00(108iAN{-l6rt)l:S- 3/ll8l d.rted the 09/lll15 !ide \hich lpplicali(n) lionr M/s. Dr. Rcddls I-abol1rl\n'ics I nas scnl tr) this Depa nr.nt lir| llxatiorr Lr, nonns undcr para:.1.7 lor the c\po ol l-(6, Methor)-l-Naphth)l) Pr1)Pionic Acid (DL Acid). Ihis deparrntcnr hrs c\arnined rhc rnrlrer and the lirllou,ing nonns ilre li rishcd u dcr para.1.7 ol lland Ilook of P()cc(lurcs (Vol l) 1009-l.l:- I Il),rl l( ll I hir issuer rr ith t)rr' lp|r(J.rl ol ,,nrl)clcnl luthoril. ヽぃl 、 1、 Iくcct)]11〕ぜ‖(ヾd lt l｀ュ lr\l)ort (,(,1ヽL | | |ヽJ I ndcr Scerclrr'\ tL)llrc(;r^e 1n]rnlol l|(l ir I,h,, c llrlT l I6l Direetoratc (;cncral ol lrrrtiun lrrdc. Depannr.nt ol (irntnterec. (Shri NLV. Sinlrh- l:l lX )). tid) o! llhl\an. Nc\ I)clhl S. No. I'l-\cct\l-(F\lclh,,).rplhirl.r. ). llldh,rl lurninc \rrlplrrtt l. \cli\ rlcd ( xrl)t,r) I ( iru\ti. l)tnir\lr I iLl,e\

⌒ Ir. No.l50 I l/676/10 I 5-l'l (Nornrs) Co\c rnrcnl ol_ lndia Ministr\ ot ( hcnricals & l:cl'tilire15 Dcpa nrcnt ol_ 1)hannaceuticals Ollfuc Menxn-andunr Subiecl: - Fixalion ol nornrs under pa|a .1.7 of Hand Book ol-l)rocedures (Vol.l) 2009-ll Case of M/s Nculxnd l,aboratorics l-td. The undersigncd is directcd to rclir 1() t)CF l U.O.No. 0l/81/50/815/AN{-16/t)F-S- i/9-10 datcd the l/9/lj !idc !hich applicarion liom M/s. Neuland Laboralorics t-1d. \as sent lo lh;s l)epartnrent fbr ll\arion of nomrs undcr para: 4.7 l'or the export of [nlacrponc. _lhis dcpannlcnl ha! exanrirled lhc nater and the fbllowing no ns are firrnished Undcr part.1.7 ol' llanrl B,'nk ul Procedurc\ (V,'1.1, 'troe-' I Norms tirl lkg .l--l-dih) drox) 5 nitrotr€nzaldeh\ dc N.N dicthr l-2-cr ano rcctamirlr l rpol'l llcnr 0 'I his issucs w ith the appNval ol eorrlpetent author;t). rRrjkrrrrr"rr Undur Sc"rclir\ l,' rlr(r Co\cnrrrl.Ir ,,1 l,t.r .l Phone:2l07ll6l l)irectoratc Cicneral of Forcign liade. l)epartrncnL ol'Comtncrcc- (Shri M.V Singh. Fl lX)). I Id) og llha!an. \r\ Delhi Ud)og Bha$arr.Nc\ l).lhi. Drled: I Febftlllr- ]0 6 I SINo l 一Ｌ〓，一

/重 Government oI lndia Department of Chemacals and Petrochemicals ′//・・ Sublect: Advance Autho“ zalon app"ca輛on from M′ s Prasol Chem cals Ltd forthe import of raw mate百al againstthe export of MESITYL OXIDE (Advance Autho「zation No 0310649496 dated 19 08 2011) (Advance Autho百zation No 0310757684 dated 12 11 2013) Ref: UO No 01′ 82′050/00912′ AM-16′DES‐ ‖/943 dated 9 09 2015 M/s. Prasol Chemicals Ltd. has submitted present application for the import of raw material against the export of MESITYL OXIDE. The application has been examined and the Department recommends the following norms for the present Advance Authorization application.

ltem of Export Qty Item of lmport Qty MESITYL OXIDE l kg 4 ACETONE 2 158 kg This issues with the approval of competeni authority. AddL industr al Adviser Tel No 011-23381430 ShH Mahendra V kram FTDO(DESJ‖ )0/o DGFT Udvoq Bhawan New Delh-14 Deptt OfC8PC U O No 14010′ 107′2011-CH― ‖dated 12 01 2016 9ρ lA Kふ｀)瀧)

ヘ F No 14010/6′ 2016‐CHJI Government oflndia M n stry of Chem cals and Fert‖ zers Department of chemicals and Petrochemicals Shastri Bhavan, New Delhi-110001 Dated: 27n January, 2016 To, M/s. Perfect lndustries Pvt. Ltd. K-34/1, Five Star MIDC, Buttibori, lndustrial Area, Buttibori, Nagpur, Maharashtra-441 108.

Subject: Application from M/s. Perfect Vitamins P. Ltd. for the import of raw-material against the

export of SOYA LECITHIN POWDER. (Advance Authorization No. 031 07724'l 1 dated 28.02.201 4) I am directed to refer to your Advance Authorization application received through Office of DGFT on the subjecl mentioned above. ln this connection, you are requested to submit the following information within 15 days of the issue ot this letter. 1 . Technical specifications including certmcate of analysis of SOYA LECITHIN POWDER to be exported. 2. Details of other indigenous raw materials to be used in the manufacturer of export products. 3. Detailed manufacluring process, material balance with details of input and output material, solvent charged/recovered indicating stage-wise percentage yield/recovery along with the technical justification enclosing therewith authentic printed technical ‖terature in support of y eld/quan“ ty ofttems for mport Deta‖ s of production of sOYA LECITHIN POWDER and co「responding raw materia:s including acetone in the year 2014-15 and 2015-16(April duly certified by cA may be fu「nished Any other relevantinformalon Addl lndustna:Adv ser Tel No 011‐23381430 CODV t●: Shn Mahender vikram Singh. FTDO(DES-3), n reference tO DGFT/UONo‐ 01′ 82′050/00110′ AM‐ 15′DES‐ 3′1394,dated 30 12 2015 4 5 cκ0 consumption of to September) Yours fa thfu‖ y, (A K ACARヽ～λL)

)8-''- 9.il 2q-7 t. No..l50 I 1/l 87/2{)15-Pl (Norlns) (iovcrnment of lndia .linistn Lrl ( henricll & |e ilizers [)cpitrtDlcnl ol Phomlacculicals tId]og Llha\an' Ne$ Delhi. the oclohcr. l0l5 Olllcc Men()randunt Subjccr: - lrixation ol r)orDs uldet fnrr.1.7 ofHand Book of Procedurcs (Vol.l)l{)09-l-+ ( r:,s olM,'s lvlr lan I-ubs l-td. l'he undersigr)c(l is direcretl ro reler.to l)CiF'l U.O.No.0l/82/50/lll6,,ANl ij,t)t:S- i/Ii00 datcd lhe 05/01/15 \idc $hich lpplication lionr M/s. Mllan I-abs l-rd rrrs sen( t(, rhis Dcpaftmcnl fir' li\atiou of norlrls Lrndcr pllra: 4.7 li)r the export oI l,amivudinc (( lrkrhexr.l Ester Route). Ihis depurtnrenl has cxarnined the tDatter and the lbllo$ ir1g nornrs arc tillnishecl under para 4.7 ol HaDd llook ol P|occdures ( Vol.l) 1009- l,l: rclLrlrerrllst.' 219 iunl Bort〕h、dridc 018 I)ipollssiunr lJrrlrogcn Phosphirt.: c、 icヽcid ― ‥ |サ lr)7 1)21,() ricth、la:1li1lc 0575 soptrpl l Alcolrol l)ireclorirle (icneral ol torcign fr'lclc. Dcpafintcnl ol Conrnrerce. (Shri Nl.V. Singh. lrl D()). t'd)()g lJha\an- Ne\ l)cll)i (llarnlli Klra\t!ir) I lndcr Secleta|r, 1() lhc (;o\crnnl(nt ol lndil l'h()nr:llr)71 I 6l ヽヽo lnlport ltcnr

F. No.3501 1/656/20'15-Pl (Norms) Government of lndia Ministry of Chemical & Fertilizers Thrs issues with the approval of competent authority. 2 (Ralkumar) Under Secretary to the Government of lnd a Phone 23071'162 Directorale General of Foreign Trade. Department of Commerce (Shri MVSjngh FTDO) Udyog Bhawan, New De hi r8 ,1{zt3 Udyog Bhawan, New Delh, Dated: 21 january,2016 Office Memorandum Sub: Fixation of norms under para 4 7 of Hand Book of Procedures (Vol.l) 2009-14 Application of M/s Mac Chem Products (lndia) Private Limited. The undersigned is drrected to refer to DGFT U.O No 01l82l050l7O2lAM14lDES-3/974 dated the 30/09/2015 vide which an apptication from M/s Mac Chem Products (lndia) Private Limited was forwarded to thts Department for fixation of norms for the export of Hydrocortisone Sodium Succinate This department has examined the matter and the following norms are recommended agarnst thrs appltcatron lmport itenr Norms Recommended for 1kg Export 0.88k9

ハハノg Government of lndia Department of chemicals and Petrochemicals s"1 . ss{ Subject: Advance AuthO“ zalon applicalon from M′ s Balali Amines Pvt ttd fOr the import of raw matenal againstthe export of N‐ Ethy12‐ Pyro‖done (AdvanCe AuthonzatOnNo 3110065577 dated04082015) Ref U O No 04′ 827050′ 01301′AM-16′DESl‖′1352.dated 18 12 2015 Mis- Balaji Amines Pvt Ltd. has submitled present application for the import of raw material against the export of N-Ethyl-2-Pyrrolidone. The application has been examined and the Department recommends the following norms for the present Advance Authorization application. This issues with the approval of competent authority 雨ヽスヽ4 (A K. AGAHWAL) Addl lndustral AdViSer Tel No 011-23381430 T ono gtnYt nmine 70% Solution | Deptt oF C&PCUO No ¨ ldaed l1 02 2●6

Governmenl of lndia Departmenl of Chemicals and Petrochemicals /B _..-...-l s/" 2jb Subject Advance Authorization application from M/s. Balaji Amines Ad. Ltd. for the import of raw material against the export ot N-Methyl-2-Pynolidone. (Advance Authorization No. 3110065576 dated 04.08.2015) Ref: U.O. No. 01/82/050/01302/AM-16/DES-|ll/1349, dated 18.12.2015 M/s. Balaji Amines Pvt Ltd. has submitted present application for the import of raw malerial against the export of N-Methyl-2-Pynolidone. The application has been examined and the Department recommends the following norms for the present Advance Authorization application.

ltem of Expo( Qty Item of Impori Qty N [Iethyl-2-Pyrrolidone l k9 l Methanol 0.377 kg 2 Ammonia Anhydrous 0.164 kg
Gamma Butyrolactone 0 960 kg This issue with the approval of competent authority. Shri Mahender Vikram Sinoh.FTDO .(DESJll) O/o DGFT. Udvoo Bhawan.New Delhi-11 Deptt. ofC&PC U.O. No. 140101 122 12011-CH-ll dated 11.02.2016 (A,K, AGA}IWAL) Addl lndustrial Adviser Tel No 011‐23381430

A F No 14010729/2011-CH‐ ‖ Government oflnd a M nistry oi Chem cals and Fertllzers Department oi Chemica s and Petrochemicals Shastri Bhavan. New Delhi-110001 Dated; 15h February, 2016 To. M/s. Benzo Chem lndustries Pvt. Ltd. 26/28-A, Cawasji Patel Street, Fort, Mumbai Maharashtra- 400001 subjectApplicationM/s.BenzochemlnduskiesPvt.LtdMumbaifortheimportofraw.materials against the erport of 2,4,6- Trimethyl Phenyl Acetyl Chloride. (Advance Authorization No. 0310798771 dated 99.2015) and (Advance Autho zation No 0310798876 dated 14.9.2015) I am direcled to refer to your Advance Authorization applications received through Office of DGFT on the subject mentioned above. ln this connection, you are requested to submit the following information within 15 days ofthe issue of this letter. ,l.oetailedmanufacturingprocess,malerialbatancewithbalancedchemicalreactionsindicating stage.wisepercentageyieldalongwiththetechnicaljustificationenclosingtherewithauthentic printed technical literature in support of yield or quantity of items for import' 2. The complete matenal balance for input and output material at each stage of manufacturing process. 3. Details of production of 2,4,6- Trimethyl Phenyl Acetyl Chloride and corresponding consumption of raw materials in the yeet 2013-14,2014'15 and 2015-16 (April to December) duly certified by CA may be fumished. lf the production has not @mmenced in the past, the details from commencement of production may be turnished duly certified by CA 4. Any other relevant information Yours faithfully, (A K ACARWAL) Addl lndustr al Adviser TeINo 011‐ 23381430 %=L鵬躙Ⅷ呪即1服輛酬∫ :写『誂 eぷ淵器L16

/8 ハ covernment of tndaa 9' 'J o Ministry of Chemicab and Fertilizers Oepartment of Chemicals and Pefochemicals Subjectl M/s. Balaji Amines Pvt Ltd. have submitted present application for the import of raw material against the export of Gamma Eutyrolactone. The application has been examined and the Department recommends the following norms for the presenl Advance Authorization application. 1 ltem of Export Otv llem ollmport Oty

Gamma Butyrolactone l kg 1 1 4 Butanediol 1 16 kg

GBL Catalyst 0001k9 This issues with the approvalof competent authority. (A K AGARWAL) Addl industnal Advise「 Tet No 011‐23381430 Shl Mahender V kram S noh FTDO rDES― ‖|)0′ o DGFT Udvoo Bhawan New Delhi― |イ Deptt Of c&Pc U O No 140,0′ 122′2011-CH― ‖daled l1 02 2016 を 2」ζ '7アプ 1)′ tl Advance Authonza10n applicalon from M′ s Balali Am nes Pvt Ltd forthe impOn ofraw matena againstthe eXpOrt of Camma Butyro aclone (Advance Autholzalon No 3110065578 dated 04 08 2015) (Advance AuthonzatiOn No 3110065636dated 14092015) ReF U O No 01′ 82′050′01303′AM‐ 16′ DES‐ ‖ !′1519,dated 12 01 2016 ReF U O No 01′ 82/050′ 01415′AM‐ 16′ DES‐ ‖ !′1527.dated 12 01 2016

Government of lndia /8 g´ スん2クノ

Subject: Advance Authorization applications from M/s Survival Technologies Pvt. Ltd for the

import of raw material against the export of 1-Ethyl-3-(3-Dimethylaminopropyl) Carbodlmide Hydrochlonde ReFi U O No 01′ 82/050/011497 AM‐ 16′ DES I‖′1253,dated 16 12 2015 1Advance AuthonzatOn No 0310797969 dated 05 08 2015) M/s Survival Technologies Pvt Ltd has submited present applcation for raw mate商al against the export of l‐ Ethy卜3‐ (3‐Dimethy am nopropyり Hyd「och10ride The app‖catOn has been examined and the Department recommends nOFnS fOrthe present Advance Autho「zation applicat ons the import of Carbodiimide the following 〇 ' ltem of ExpOrt Oty Item of lmport Qty 」 :1:蔀脇 :な躙ぶ lil‖::propyl' l kg l N,N‐Dimethyl‐ 1,3‐ propanediamine 1 60 kg 2. Dichloromethane 4 05 kg 3. Potassium Hydroxide Flakea 2 25 kg 4. Potassium Carbonate Anhydrous 1 80 kg 5 Chlorofonll 6 30 kg 6 Acetonitrile 2 40 kg Bff<'i.-.r,o ^*,',lI"f,:ifff:l Tet. No. 011-2338 1430

t8 -----/ Governmentorndia fift'*a$a S Subject Advance Authorization application from M/s. Songwon Specialty Chemicals lndia Pvt. Ltd. for the import of raw material against the export of EDOT (3,4- ETHYLENEDIOXYTHIOPHENE) (Advance Authorization No. 34100416,l1 dated 19.10.2015) M/s. Songwon Specialty Chemicals lndia pvt. Ltd. have submitted present applications for the import of raw mateial against the export of EDOT (3,4- ETHYLENE DIOXYTHIOPHENE) The application have been examined based on the additional anformation furnished by the firm. The Department recommends the following norms for the present Advance Authorization application. Addl industr al Adviser Tel No 011_23381430 C｀ Item of Export Qtv nem Oflmpon ｙＯｔ一ヒDOI(3,4- ETHYLENE p10XYTHloPHENE) l kg l Dmethy1 2,2‐thiobisacetate 2160 kg 2. Dimethyloxalate 1 510 Kg 3 Sodium Methoxlde Soluton 30% … 492K9 4. Dimethyl Formamide 0360K9 5 1,2‐Dichloroethane 1 94 Kg 6. Sulfolane 0 600 Kg lA K AGAR"AL) ER M SI Deptt. of C&PC U o No 14010/10/2015‐ CH「 FT 1222016

Government of lndia SubleCt Advance Autho日za"on app cauon frOm M/s Stening Aux‖ aHes Pvt Ltd for the import of raw mateHal againstthe export of Surfectants lAdvance Authorization No 0310798188 dated 14 8 2015) Ref:- DGFT/ U.O. No. 01/82/50/01 1 56/AM'16/DESlll/'1 251 dated 16. 1 2 201 5. l\r/s. Sterling Auxilaries Pvt. Ltd. has submitted present applications for the import of raw materials against the export of Surfectants. The application has been examined and the Department recommends the following norms for the present Advance Authorization application. This issue with the approval of competent authority. /θ c′ /・ ′ダ雉 “ 面 Ⅵ府am s¨ に「 DOイDE釧)αo DG日珈 ∞師awttNew Ddh」 1 Deptt Of C&PC U O No 14010′ 64′2043-CH― ‖dated ヽ, 022016

ltem of ExDort Qty Item of lmport Qty l.Sterocare TN 80(U) (Polyxyethylene Sorbitan Mono Oleate) l kg 1 0eicAcd 0 2190 kq 2 So「bito1 70% 0 2019 ko 3 Ethylene Oxide 0 6971 kq 2.Sterol 1209 ( Lauryl Alcohol Ethoxylate/ Lauryl alcohol 7.5 mole ethoxvlated) l kg l Laurvl Alcoho 0 3770 kg, 2 Ethylene Oxide 0 6420 kg (A K ACARWAL) Addl industr al Adviser Tel No 011‐23381430 / ハ

´ ハ Government of lndia -:a?:- Ministrv of Chemicals and Fertilizers ^ ,to .72 8 Departmeniof Chemicals and Petrochemlcals I "

Subject: Advance Authorization appllcation from M/s Sterling Auxilaries Pvt' Ltd for the import

' of raw material against the export of Stero Sorbitol 70016 (Advance Authorization No' o3'10798'195 dated 14 08 2015) Ref:- DGFT/ U.O' No' O1 /82/50/0'1'1 58/AM1 6/DESllU1 252 dated'1 6'1 2'201 5' M/S.sterlingAuxilariesPvt,Ltd.hassubmittedpresentapplicationsfortheimporlof ,", ,ri"ri"t" "g"in"t the export of Stero Sorbitol 70% The application has been examined and the Department norms for the present Advance Authorization application This issue with the approval of competent authority oF C&PC -3‐ CH‐ 11 dated 022016 recommends the following Addl industnal AdViSer Tel No 011-23381430 Item of lmpo( l nem ofExPOn l So「bR01 70% (A.K, AGARWAL)

ハヘ lr. No.:150 I 11676/1015-Pl (Nofln) , Corcmnlent of lndia l\4inistry ol ( hcrnicals & lertilizers l)cpartrnc n I o l- I'harmaccut icil ls tid)og llhrNan.i\c\ l)cthi. Drled: I l:cbruirr\ . l0 l (r Olllc!:Vk!tq!r!!r1l]l SLrbiect: - Fixation rrf norrs Lrnder p m .1.7 of Iland Book ol ltoccdures (Vol.l) 2{)0()-11 C'0se ol M/s NcLrllnd Laboral(r[ies Lld. lhc undcrsirncd is directcd to rclcr to D(;FT IJ.O.No.0l/8]150/{)1106/,4N.1-l6rl)FS- l/1170 dllcd thc l(rll1l5 r.idc rrhich application lioD M/. Ncula d Laborik)rics l.ld. sLrs \cnt t() lhis l)epartrDcnl li,f li\ilti(rn ol t)(,11n\ Urrdcr para: .1.7 l()r lhe c\pol.t ol l.er,elir.r!cL.Ii). 'Ihi\ dcpl nrenl has crarniDed lhe nrillttr and the li)llowing nornls arc lirrnished Undcr purir .1.7 ()l- I krd llook oJ I'roe.drrc! (Vol.l) ll)0()- l.l:- S No 0 683kt lrrrp(,n ll.r ヽ J■ コ 1,2L‖ J‖ JiOq Hl l-('hlorobut\r\ I ( hlori(1. Acctonitfi,c I'(,tls\iu r ( a )() ltc l\lclh\ lc ne ( hlorlJr l)i-lsoffop\llJhcr I his issues l ilh Ihc lpptoral ol corrpelent authorit). (ltllikunlilr) UDdcr Sccrcun, to lhc (;olcflrn1cnr ot lr iil l'honc:li07ll6) Direct(n'ulc ( icneril ()t-lru.!.iSn [rild!. f)\jpirrtrnr t ol- ( on] rcrc(. (Shri Nl.V. Singh. F I DO). t (l(u Ilhu\. t. Nc\ I)ellri 為

ハ「 No 350111377/20141)l(Norn〕s) (it)、cHl]ncnt ol I!ldia ヽ■1〕、1 、 o「C1lcn,icals& 「ぜ111 1∠c rs l)ぜ1):‖ tぃじ],tOfPl.l「lll:lCCut C.lls tJdyrg Illrirrr rrn.Nc* l)elhi. l);rlt'(l Ih. .1Lrrte ll)li ( )llice Memorandunr Subiecl: - l-ix.rliorl ofnoltns un,Jcr purr.1.7 of lland llool of P.occdurcs (V(,1 l)l(ll)()-11 ( rsc ,', \l . Vi.i.rr. ir,r:r.uri(' I ,,,. Ihc uDdclisigned is dirrcterl lo reler 1o D(jlil tl.O.No.0litll,'50iljil & 1:51'A\l- I 5.i DES-lr 16 & I 9 (latcd the 0 I 105.' I 5 r ielc $ hich applicltior) tionr M,rs. V iilr\ x\ri ( )r-l]rnics Llrl \as senl 1() lhis I)epaltrl1cnt krr liration ol'nor-nrs un(lcr pilril: 1.7 lbr the c\f('rl ('l l_tluoro-!r 2-l!lethl l-l-()roprol)! l)-g-O\o-N-ll-l)iphen! l llenzcnc Butnnenmidc (l)ikek,n(- lnfermrdi{t( lor ,\tor{slalin)/l)Kf--l). _lhis depurlll)cnt has c\alnillcd lh( nrilll\rl rlld lllc tirlklring nonrs arc tirrnishcd undcr Dirr-1.7 oflland lltxrk oll'r'(rccdurcs (/(rl.l)1009'l-1:' lnrport ltcrn Otr lteconrurcrrrlcri kr'liu. /θ 荊 9η ヽ1ビt〕、| |、ぃ1'tli、 l、l ヽcct〔ttビ ヽ 111ヽヽ) l\rlassiunr Cirrbouatc ]1ヾ ()il l- I his issucs rr ith tlr.' approral ol I)ircclor(l'l). Dir-ecto|atc (icncral of Iirlr-ign I |adc. I)cpa(lrcnt ol ( olrnrercc- (Shri N{ V. Sirrgh. l- I I)()r. IidroS l]harrart. Nc\\ 1).lhi ()ヽ2 ()76 08) 047 (lJan)lli Khastsirl tTndcr Sccrctar] to drc Oo\ rrnrlrcnl of lndiit l'honc:ll07ll6l \ N,i I l ltror'(jh(rt,,.rtt

ノ ' Advance Aulhodzalion appljcaljons. Authorzation No 0310718082 dated 2412201 tem oF ExpOrt Oty Oty BUTYLATED HYDROXY ANISOLE(BHA) l k9 HYDROQUINONE 01247K9 2 TERTIARY BUTANOL 0839k9 3 PHOSPHORIC ACID 00 kg 4 HEXANEOO kg nce Autho「zation No 0310795524 dated 24 4 204 l llem of ExpOn Oly Oty Arcmalic derivative of diphenylamine(ADA) l kg l DIPHENYLAMINE 0447 K9 2 ALPHA METHYL STYRENE 1230k0 3 ACTIVATEO CヒAY 0200k9 (Advance Authorizalion 瓦 Govemmenl ol lndia Minislry of Chemicals aod Ferlilizers Department of Chemicals and Pelrochemicals ,′ /・′ '′ ′ Sublecl Advance Autholzalon appicalon from M/s Yasho indusl● es Pvl ttd for the imporl of raw matela s againstthe export Or BuTYLATED HYDROXY ANISOLE(BHA).elc The appicatons has been examined and the Departmentrecc mmends the rolowing noms forthe present 0340798585 0310798239 ｄｄｅｅａａｄｄ 3132015) 2082016 ００ＮＮ YANT 0 2020 120% SOLUT10N OF TERTIARY BUTYL HYDROOulNONE) l HYDROQUINONE 2 TERTIARY BUTANOL 3 PROPYLENE CLYCOL Authorizaton No 0310799241 daled 6 10 20イ l ltem of ExpOrt Oty nem Orlmpon Qty YANT 0 3030 B(30%SOLUT10N OF TERTIARY BUTYL HYDROQUlNONE) k0 HYDROQU,NONE 0423 K9 2 TERTIARY BUTANOL 0312 k9 3 PROPYLENE GLYCOL 0700 k0 This issues with the approvalo, coflpetent aulhority. Shl Mahender Vikaram sinoh FTDO (DES‐ 3)0′o DGFT Udvoo Bhawan New Delhi-11 Deptt Or C&PC uo No 1400′ 95′2011‐ CH― ‖ dated 23 11 2045 (A K ACARVVAL) Addl lndustlal Adviser Tel No 011‐20031430

´″'レ Shastri Bhavan, New Delhi-'110001 Dated: 'l lh February, 2016 To. M/s. Malwa Oxygen & lndustrial Gases P. Ltd. Sector-C. lndustrial Area, Ratlam. M.P.-457001.

Subject: Application from M/s. Malwa Oxygen & lndustrial Gases P. Ltd for the import of raw-

material against the export of BIS (4-Fluorophenyl) Ketone. (Advance Authorization No 56'10004674 dated 09.09.2015) I am directed to refer to your Advance Authorization application received from Office of DGFT on above mentioned subject. You are being advised to submit the following information within 15 days of the issue of this letteri Detailed manufacturing process, material balance with balanced chemical reactions indicating stage-wise percentage yield along with the technical justification enclosing therewith authentic printed technical literature in support of yield or quantity of items lor import. Details of production of BIS (4-Fluorophenyl) Ketone and corresponding consumption of raw materials in the year 2014-15 and 2015-16 (April to September) duly certifled by CA may be furnished. lf the production has not commenced in the past, the details from commencement of production may be furnished duly certified by CA Any other relevant information F. No. 140'1 0/08/2016-CH-ll Governmepnt of lndia Ministry of Chemicals and Ferlilizers Chemical Division 1 2 （０ Yours faithfully, (A K ACARWAL) AddL Industrial Adviser TeL No 011-23381430 shn Mahender V kram S ngh,FTDO(DES-3), n reference to DGFT′ UONo― 01′ 82′ 050′ 01182′ AM‐ 16′ DES‐ 3′1451,dated 12 01 2016 ぃlスい

F No 35011,433/2015‐ Pl(No"s) G()vcrnlnent or lndia Ministry ofChcmical&l'crlHizcrs Dcparmcnt Of Pharm¨ cuticats ″ Udyog Bhawan, New Delhi. the October. 2015 Office Memorandum Subiecl: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009- I4 Case of M/s Alchymars ICM SM Pvt Lld. Ihe undersigned is directed to refer to DCFT U.O.No. OU82/50ll5lAM-l6/DF,S-31525 datcd the 08/07/15 vide which application from Niys. Alchyrnars ICM SM Pvt Ltd was sent to this Departmcnt t-or tixation of norms under para: 4.7 for the export of 2-Methyl Mercrpto Phcnothirzine l)rug Intermediate- This department has examined lhe matter and the following norms arc I'urnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-l4:- S No Inpon ltcm Ql)'. Rccommcndcd k8/kg. | I'i\lclh) I Ilcrcapl() /\r)iline 236 (Barnali Khaslgir) IJndcr Sccrelary to the Covernment oflndia Phone:23071162 l)irectorate Ceneral of l'oreign Trade, I)epanment ol Commerce. (Shri M.V. Singh. FTDO). tJdyog Bharvan. New Delhi

^ _-E - 9 ',,/b 3t? lr No.l5{)l 1/413/201 5-l,l (Nomrs) (ior,ernrncnt ofIndia Miiislr) ol'Chemical & Fertilizels l)epa lrcnt of Pllarnlaccuticals Lld)og Bhruon. Ne\ Delhi. the Ocloher. l0I 5 ( fr'lrq ll9l]]aratldrllt! Subiecti - lii\ation ol-nr.rl,nrs under pa|rr {.7 ol'lland llook ol l)rocedures (Vol l)101)9-11( ulc of M/s Mllan l.ahs l.td. I he udersigncd is dirccted to rcltr k) DGlrl' tl.O.No. 0l/li2/50/5 1 1/.{ '1- l 6 r l)l]S-i 1j.l6 daled lhe 09/07/15 ridc s,hich apllication f'rom M/s. MvlaD l-ahs Ltd rras sc r lo rhis I)epartnrcDl tin li\aliolt ol'noo)ls rrnr.leI para: :1.7 lor the erpon ot Parr)rctinc [l]drochkrridc. 'lhis departmr'nt has exanrinc'd lhe nutlcr and the lbll()wing lonns are lunrishcd unclcr.para 4.7 ol ljnnd Ilook ol' ProcedLrrcs ( Vol.l ) 1009- I.l:- lnrprrrt ltrnr (.)lr. llecon)lrrenLlct] L! [t _)_rr.ll〕、-lR (‐ 1 1 1tlo「tll〕lC]1ヽ |)‐ 3ヽ‐ 11、(11()、、11,ct]ヽ |‐ ),lc-th\ I l'il)rri(linc I Irlr)\ ll\ll)) tcthane SLrlfirnr I ( hlorirlc 1 ヽ 6 フ (,5ヽ ()ヽ5 lr'ictltr llrnrirr. l\oprol)\ l .\lc,)lr()l l)ircclorirlc (icncrill ol t.orci!ln I t.arlc. l)cpa nrcnt (,1 (bntnlcrcr. (Shri i.1 /. Si,)gh. l:l lX ) ). Lillog llluuan. Ncrr Dclhi (lla|Itll Kha\t!it ) []nder Sccrclir\ lo lhe (;o\emnlc|l ol lndiit l,houc:l.tl)7ll()l ヽヽぃ１　　　０ ´

イ F No 14010/3/2010CHJl Government oflndia Ministry ot Chemicals and Fertilizers 9鴻 To, Shasttt Bhavan,New Delh‐ 1loool Dated:1lm February.2016 Yours faにhfu‖ y. M/s. Perfeci lndustries pvt. Ltd. K-34/1. Five Star MtDC, Buttibori, lndustrial Area, Buttibori, Nagpur, Maharashtra-44'l 108.

Subject: Application from M/s. perfecl Vttamins p. Ltd. for the import of raw-material against the

export of SOYA LECtTHtN PHOSpHATtDL CHOLTNE pC. (Advanca Authorization No. 0310799705 dated 19.10.2015) _ - , I am direcled to refer to your Advance Authorization application received through Offica of DGFT on the subjec{ mentioned above. ln this conneaion, you are requested to submlt the following information within 1S days of the issue of this letter.

Technicat specifications including certificate of analysis of SOYA LECITHIN PHOSPHATTOL CHOLINE pC to be exported. 2 Technicar specifications incruding c€rtificate of anarysis of soyA LreurD LEcrrHrN to be imported.
Details of other indigenous raw materials to be used in the manufacturer of export producls.
Detailed manufacturing process, material balance with details of input and output material, solvent charged/recovered, by produc{s received indicatang stage-wise percentage yield/recovery atong with the technical justjfication enclosing th;rewith authentic printed technical literature in support of yield/quantity of items for import.
Detaits of productjon of SOYA LECITHIN pnO6pHairof_ - CioLtNE pC and corresponding consumpiion of raw materials in the year 2014-i5 and 2015-16 (April to Oecember) duty certified by CA may be fumished.
Any other relevant information “… 批面 1鵠χ脚′理 ,1鳳 DO IDEStt hにたに濯常蹄濫 l '6,dated ll o1 2016 lA K AGAttVAL)

― l:. No.-150 I I i68 l/:0 I 5-PI (Nonns) (i(n cnrnrcrr ol_ lndia Nlinistr] o, ( hcrnicals & Fcflilircr
I )cparlnrcnl ol l'harmaceuticals Lldlog tlhr!\irrr.Nc\ l)(lhi. l)atcd: I lrcbfuilf. ll)l(, Olll{. \ l!rnoran(lunr S{Lbicct: - F;\llion of norrr\ undcr parit 1.7 (,l Hand Rook ol l)roccdurc\ (Vol.l) 100()-11 ( asc ()l M1s Srini I)hrfluitceutiexl\ Lld. lhr undcNigncd is dirceted tL, relir l() I)CFT ti.O.No.0lr8l,50i l15li.\Nl l6l)1.S, .i,ll(,8 darcd thc Ii/9/15 \i(lc \hich ilpplicirtiol llrnn M/s Srini l'hannLrccutie ls l.d. \a\ .rr lo this l)eparlnrcnt lor il\rtiorr ol Iornr! Ltndcr para: .1.7 lirr lhc e\porl ()l-llurt,r.rrrrirrt \4rlc te. _Ihis dcpartnrent hus c\unri cd rlrc nrltler and llrr lirllo\inS norrns llre tir,lri\ rc(l undcr p.ll -1.7 r)l' I land lIiLrk ol l)rrrcc'du|cs ( Vol.l ) 1009- l.l:- \rrrnrr Recr.mnrenrlcrl lar 1k3 I \Dt, r | りヽ15ヽJ t,18ヽロ 1313k蓼 | lar 1k3 I \Dt, r | .01i,! う t his irsuc\ \ ith thc irl)pr)\al ol.onrl)clcnl aulhoril]. [.lnder SecreluD to thc (i()vcDnlcnt ol lo(liir I'hone:2107111)l l)ircc1(nate (lcneral ol-l:orci3rr I radr. l)eparlnrcnt ot ( onrtrlcrce- (shri Nl V. Singh. I IDO). I dlog llharran. Ncr Dclhi lnrpoft ltcrl I-( hlolrr-,1-Mcth0r) Iltrtrrrc 1 (Tritluorlmethr I lllcnzL,|irr'rli Tcl:`11、dlolllran l-chknl)cth\ Iilnrill. ()(lir fr 1 l\ rlrr)\lLl.' \ 1iL ,,r l'cr r' .. ヽNo | | |

^ Ir. No.l50l lil4()/2015-PI (Nonrls) n (iovernmenl of hdia /d Minisnl of ('hcmicals & Fe(iliTers

^- Department of l'harmaceulicills 5y, //o gyS LJdlog Bhr\rtn.\e\ Delhi. I)alcd thc Scplcrnbcr. 2015 Ql!!c l4!t!!raldr!tr Subjecl: - lixalion ol-nonns under para {.7 olIIand Book ol Proccdurcs (V(Jl.l) l0(}+l-l ( tls. of M/s Lakc ( hcmicals P\t Lld- lhc undcrsigncd is dirccted 1o rclcr 10 DCFT U.O.No.0l/82/50/547/AM-15/l)hS-lri9 dated tlrc l4/05/15 vidc rrhich application liom Nl/s. Lake ( hcnlicals P\1 Ll(l "'.ls seDl to lhis Departnrcnt lbr lixation of nonrs Lurclct para:4.7 lbr the e\po( ol fl-Chloro-6-(2- Fluorophcnyl)-l-Mcthl l--1A, {-Dih1d ro--11l-Imidazoll,5-A | [1,4] Rcnzr)diazepinc. lhis departnrcnt has examincd lhc nrattel und tlre fbllorvilg nor'nrs arc turnishcd t)ndcr pam _1.7 ol- Hand Book ofProcedurcr (Vol.l) 20(X)-ll:- S No Inrl)ort llrnr 1-Aminomethl-7 ( hloro-l.l-l)ih)(lro-5(l I ILI{)phcnl.l)lll al-l}cnTodiil.zrpinr l)inraleale I ricthr I Oltho .\cctlt.' Qty. Recorrnrcndcd kgikg. (llafl1ali Khnslgir) Under Secrctary to the Cioycrnnlcot of lndia l'hont':ll07l 161 ― 仁 l)irectoratc' (ieneral o, li)rcilrr I radc. l)cpartnrcrt ol' ('onlnlcrcr. (Shri l\1. V. Singh.I fD()). I kl)og llhlwarr. Neu l)tlhi 資 252 ()90

∂ 多バん `で'一 ´ ∫ ^ ( l. \rr.rroll l-ll luli-Pl tN rrI.r (lor t'rrrncnt ol- lndia Nlirri.rr,, r,l t lrcttticrl & Iertiliz.'r. Deporlrrrcnt of I)harnraccuticals Ncw Dclhi thc I rcll og []hluan. Nor,crnbcr. l0I 5 L)lllcc Memorandunr

Subject: - Iiixation of norms unrlcr pam 4.7 of I land ,rouO ot Pt,,."6u1c5 1\rol.l)

2009-14 Case ol'M/s Shasun Pharma Ltd. 1he undersigned is dilectccl to lefer to DGFT U.O.No. 0l /ltl/50/140/A M- l6lDIrS-3/202 datcd the 29106/15 vidc which application fionr M/s. ShasLur Pharma l-td was scnt to this [)cpa(Dl!'nt lor lixation ol'nonns undcr para: -1.7 lirr' the exporl rtl'Gabapentin Tablets USP 800Mg. This depanl'nent has examined thc rnatter and it is lcclucsted that D(iF l rnay call copy of Mastcr-llatch firrmula duly authcntictcd by Quality-Cortrol lncharge, fi-orn thc llnn. 2. 'l'liis issues with the approval ol'cornpelent authority. (ltaj KLunar ) Undcl Sccletary to the Govclrrmcnt ol'lndia I']honc:13071 I 6l Dilcct()fa1c (icncral ol'lrorcign 'l lade. Dcpanlr)ent of ('orrrnerce. (Shri M.V. Sinsh. l: I DO). Lldlog llharvan, Ncri I)clhi t

燿一ハ F. No.350l l/34212015-PI (Nonns) (iovcrnrnent of lndia Ministry ol ('h!'mical & Fcrtilizers Depanment of Pharmaceuticals New Dclhi. the (Jflice Memorandurn

Subject: - Fixation ofnorms undcr para 4.7 olHand Book ol'Proccclulcs (Vol.l)

2009- | 4 Casc of M/s Shasun l)halma [-td. -l-he urrdersigrred is directecl 1o reler to DGI;T U.O.No. 0l/8:/50i l-.]9/A M- l6lDLS-3/338 datcd thq 02/07/15 vidc which application ftrrtn M/s. Shasutr l)harrra I-td was scnt 1tl this l)cpannrcnt lbl lixation ol'nonrs under parl: 4.7 lirr the expon ol'Gabapentin Tablets USP 600Mg. This deparlment lras cxatninccl the matter and it is requestcd that DGI:T rnay call irorn the fim copl ol'Mas1!'r- Batch firrmula duly authentictcd by Quality-Control Inchargc. 2. 'l-his issues witlr the applo\ill ol'competent authority. (Rai KLlrnar) lJndcr Secrctary to the Govcrnmcnt ol lndia Phone:ll07l l6l I)irectorutc (icnclal ol lrorcign'l'r'ade. [)epadn]ent of ('omnlelce. (Shri M.V. Singh, IIl DO), (Jdy og tlharvan, Nerr I)clhi ,g =-.-----=- w. j38 Udyog Bharvan. Novcmbcr'. l0l 5

ヽ F. No.350l l/l 53/2014-PI (Norms) Government oflndia Ministry ofChemical & Fenilizers Udyog Bhawan. New Delhi- the October. 2015 Office Memorandum Subiect: - Fixation of norms under para 4.7 oi Hand Book of Procedures (Vol.l) 2009-14 Case of M/s Alembic Pharma Ltd. l he undersigned is directed to refer to DGFT U.o.No. 0l/82/50/82lAM- l6IDES-3/54 dated the 12106/15 vide which application from lr4/s. Alembic Pharma Ltd was sent to this Department lbr fixation of norms under para: 4.? for the export ofAzithromycin Slep4. This departmcnt has examined the maiter and the following norms are fumished under para 4.7 of lland Book of Proccdures (Vol.l) 2009-14:- S. No. lmpo11 Iicrn Ql). Ilecommendcd. I -:r\thromvcin llase t JSP 1.75 kg/kg A う Hydroxylamine I Icl 0.91 Melhanol 2.'72 4 Methanc Sulfonvl Chloridc 0.72 ヽ 6..15 6 Ilthvl Alcohol 2.{i I 7 Plalinum Catalyst with base ofActivated Carbon (57o pl/c) l.oogm,/kg A (Barnali Khastgir) Undcr Secrelary to the Governmenl oflndia Phone:21071162 Dircctorate Cencral of Foreign 'I rade. Department ol Commerce, (Shri M.V. Singh. Irl-DO). Udyog llhawan. New Dclhi

ヘ t8 /3 Ir. No.i50 I I /117/201 3-l)l (Nornrs) ( it[,.'rnnlont of India \4inistr\ (){ Chenrical & Fertilizcrs I)cpatrlcnl ol l)harmacc!ticals (lt. Ilcconrurcndc(l l!g+r 0596 4,+ 5.00gn,/kg 0.a17[g lS 4:.+1+{]_J o.]rt aw L ihis issLrcs \ith tlrt ap|roral ol l)ircclof((osl) (Rui Kunrar) UDdcr Secretary lo the Govcntrncl]t ol'lndia l'l-Nornrr Dir eclorate Cencral of I olcigu 'l rade. Dcpartnrcnt olConlnlerce. (Shri R.('. Meeru. Dy. D(;FT). Lldfog llhawan. New Delhi. ル%.gs3 t cll og llhasan. Ne! Delhi. the I I'r Ocrohcr.. l0l l QItirl l4!urqa!dt!r! Suhiecl: - Irixalion ofnornrs rrndcr pa|a +-7 olIlaDd Book ol l)rccedurcs (Vol.l) 100()-ll (ls( oi ivlls l)SrVl,\rir;-Lrtccli\es Irrdia I-td. 'lhc undersisncd is directed to rclcr to I)c[-] tl.O.No.0lisl/501119lt,..\.|l l)t,S-l,.te dutcd lhe 09/0.1/l'i ridt \lrich rcprcsrlltiltion lionr M/s. DSM:\l1ri-lnt-cctircs L]din Lld \irs siJnt to this Dcparlment lbr lixation ol nonrs undcr para: ,1.7 lbr thc expor.l of Arrrpicillin 'l rih]'drate Through 6-,\PA Route 'l hrough Unz!,matic Routr. This drlanntcllr has e\llnincd the mitttel an(l thc lirllo$,ing Dornls re lirrnished under paru 4.7 Lrl Ha Ll lirok ol' Proccdurls (Vol.l) 2(XX)- l-l:- ormiclase llnzr e nrt- lnrpon IL. rtr S No １１　　　，一　　　ヽ、　　　１ ■

ヽ、__ _1:I `,'″ 。り″´ |゛In str,ci Cllen]Ca s&■c t1 2CI= Department of Chemicals&Pet oChemicals Room No 223,A VVng, Shasttt Bhawan,New Delhi410 004 Dated the 」uly 23, 2015 0FF!CE MEMORANDUM Sub: App:ication from M′ s Re‖ance!ndustries Limited,Mumbai for issue of advance licence(Licence No 0310792860 dated 13.032015)for eXport Of Orthoxylene and correspondilg impOrt― reg The undersigned is directed to refer to U O No 01′ 82′050/01359′AM― 15′DES I‖ ′287 dated 04 07 2015 from D G F T on the sublect cted above The proposal ofthe nrm has been examined in this office The Department of Chemicals& Petrochemicals recommends the present Advance Authorization App‖ catiOn on the fo‖ owing basis:― Name of Export Items (s) Qty in MT Name of import Item (s) Ouantny Orthoxylene ＯｎｅＭＴ Reformate 1 2565 MT Relevant Catalyst and Chemicals used ln manufacture of Orthoxylene CIF value‖ mned tO o 9o% of FOB value of expon This has approval of the competent authority. 尤 ´ (O P Shama) 」oint lndustrial Adviser TeL 01123071442 Telefax:011-23071187 Eman:omshamaOnicln ShH Mahendra Vikram Singh, Foreign Trade Development Ofrcer, Directorate General of Foreign Trade, Depanment Of Commerce, Ministry of Commerce and lndustry, Udyog Bhawan,New Delhi Tel No 23061562,Extn 269 Fax:23062225/23061613

ヘヽ lr. No.j50ll 6l.li l0l5-Pl lNorms) CL\cmnrant of India Minisu_\ ol ( hcmicals & Ie(ilircrs l)eparlrnenl ol l'hannaceuticals (ld)oB Bharan.Nc\ l)c hi. l)aled: I lrchfirr. ]r)16 ( )lll(. \lcnmrrndrnn Subjcct: - Fixation ol'rxfnrs under pam -1.7 ol Hand t]ook ol l]occdurcs (Vol.l) l(]09 l.l Case of l\4/s l)hnnukr Labs l-1d. 'lhc undersigned is dirccted to relcr k) D(jl"T U.O.No. 0l/82,'50/ 1049/AM- I 6/DtS- .l/l-1,17 (hicd thc llt/ll/15 !ide \hich npplicatiolr liom M/s. l)hanuka Labs Ltd. Nr\ \ent to this l)cprnnlenl tbr ll\ ti(,I ol [orms undcr nara: .1.7 lbr lhc e\por't ol_ ( cliro\inrc A\clil Aflrorpho(s Stearic acid c,)llcd 159/o p(r\dcr. lhis dcpartncnl hos c\arnincd thc rrralle[ 3nd the lblk)\ring norms arc lirnrished undcr pum .1.7 o[ Hand Book ol ,'rocedures (Vol.l) ]00q l4r- tl-i,t( e (ot:slecrl l-7-ixnirro ccph.r l'hosphorous pcrrlir rhloridc {l)-l-Medro) inrin()-(l uDl-l-\l)i\cclic acid anrnrortiunt Nlclh\ lljne eh lori(lr Methr I Cuanidine N.N Dinrelh\ I Aeet.rridc lith),1 Accratc Slea[ic acid Activat.^d CarboI l his issues $ ith the upl)r()val ol eonrpclcnl authoril)'. ic actu 0 I)rccto`atc Cenc閾l of Folcig l tradc Dcparinicnl ol(lolnl1lc「cc (Sh面M V Singh「H)(" Ud、o_t13ha、an Nc、Dc hi Nornrs Rcc(rn]lncn(lcd li)r Ikg F\B)r1 __1■壼フkg 1)Ot'2'ヽ■ (lt ikunur) tJndcr Secrcr r) t() rhe Covcrnrncrl (rl lndir Phonc:ll07lI(,1 , |, 11ヽヽせ __012,ks O l10kg (,4り、世 0311k 01)|(,ヽJ lrnporl lrrfr srr lt. | \ l.rlr.r, " l 匡 ~l c l orost lDlltDnsl〔τttnatc ~~可


＼
彦
F No350‖ ノ467/2015-PI(Norms)
(}ovemmcnt oflndia
静
Ministry of Chemical & Fertilizers
DePartment of Pharmaceuticals
UdYog Bhawan,
New Delhi, the November,20l5
Of'flce Memorandum
Subiect: - |ixation of norms under para 4.7 of Hand Book of Procedures (Vol l)
2009- l4 Case of M/s Vision Drug Prt Ltd.
't'he undersigned is directed to refer to DGFT U ONo 0l /82/50/189/AM-
l6/DFIS-3/615 dat;d the l5/07/15 vide which application from M/s Vision Drug
Pvt l-td was sent to this Department for fixation of norms under para: 4.7 for the
export of Homo Veratronitrile (HVN). This department has examin-ed the matter
and it is requested that DGF-T may catl lollowing technical details from the firm
viz-.-
(a) F-nd-use ofthe Export product.
it jCornpt.t. and Baianced chemical reactions showing molar requirement
o1'each input and 7o yield on molar basis'
(c) Rcquirenlent & Recovery of Solvents.
iaieasi production vis-2t-vis Actual consumption of all imported inputs
duly certified by Central Excise Authorities'
2. 
This issues with the approval olcompetent authority'
(Raj Kumar)
Under Secretary to the Govemment of India
Phone:23071162
Directoratc (;eneral of Foreign Trade'
Department of Commerce,
(Shri M.V. Singh, FTDO),
Udyog Bhawan, New Delhi

ハ
Government of lndia
Ministry of Chemicats and Fertilizers
SubleCti Advance Autho百zamon applCanon frOm M/s Knshna Anloxidants Pvl Ltd for the
mport of raw material againstthe export of Tri:sodecyl Phosph te
(Advance Authorization No.0310799307 dated 09.'10.2015)
Ref: u.o. No. 0'l/8250/01359/AM-16/DESIll/1524 dated 12.01.2016.
M/s. Krishna Antioxidants Pvt. Ltd. have submitted present appiication for the import ot
raw malerial against the export of Tri lsodecyl Phosphite.
The application has been examined and the Department recommends the following
norms for the present Advance Authorization application.
1 ltem of Export
Qty
Item of lmport
Oty
Tri lsodecyl Phosphite
イ kg
'1. Yellow Phosphorus
0 067 ko
2  Phenol
0 062 kq
3. lsodecvlAlcohol
0 990 ko
Addl lndustrial Adviser
Tei No 011‐23381430
shn Mahendra Vikram Sinoh FTDO(DES‐ ‖I)0′o DGFT Udvoo Bhawan NeW Delhi-11
Deptt Of C&PC U O No 14010′ 100′2012-CH‐ ll dated 15 02 2016
(A K ACARVVAL)

λ
Government of lndia
カ
―
~
,ノ
D‐
~
3
## Subject: Advance Authorization application from M/s. Krishna Antioxidants Pvt. Ltd. for the
import of raw material against the export of Di lsodecyl Phenyl Phosphite.
(Advance Authorization No 0310799303 dated 09 10 2015)
(Advance Authorizat on No 0310789849 dated 30 09 2014)
Rer u O No 01′ 82750′01360′ AM-16′DES―‖
1′1431 dated l1 01 2016
Ref U O No 01782150′ 01180′ AM-16′DES‐ l‖′1387 dated 30 12 2015
M′s Krishna Antioxidants Pvt Ltd have submitted present app‖ cation for the mport of
raw material againstthe export of Dilsodecyl Pheny:Phosphite
The application has been examined and the Department recommends the fo‖
owing
norns forthe present Advance Autho「izat on app‖ cation
l   tem of ExpOrt
Oty
Item of lmport
Qty
Di lsodecyl Phenyl Phosphite
l kg
l  Phenol
0 238 kg
2. lsodecylAlcohol
0 751 kq
3. Yellow Phosphorus
0 080 kq
(A K AGARWAL)
Addi lndustna:Adviser
Tel No 011‐23381430
shn Manendra vikram sinoh FTDO(DESJ‖
)0′o DGFT Udvo●Bhawan New Delhi-11
Deptt Of C&PC U O No 14010′ 100′2012-CH‐ ‖dated 15 02 2016

Government of lndia
lvlinistry of Chemicals and Fertilizers
Subject 
Advance Authorization application from M/s' AVA Chemicals Ltd' for the import of raw
mat;rial against the export of Disodium Zinc EDTA (Zinc c.ntent 15% (+10 5%)'
Ref: 
U.O. No. O1/82/O5O/247IAM-16/DES1|V462 dated 7 '7 2015
U.O. No. O1/8ZO5O/759/AM-16/OES-llr51 dated 10'8 2015
U.O. No. O1/82050/761/AM-16/DES-|llr22 dated 4'8 2015
U.O. No. O1/8ZO5O/248/AM-16/DES-llU393 dated 7 7'2015
M/s,AVAchemicalsLtd'havesubmittedpresentapplicationicrtheimportofrawmatedalagainst
the export of Disodium Zinc EDTA(Zinc content 15olo (+10'5%)'
The application has be€n examined and the Department recommends the following noms for the
present Advance Authorization application'
Nハ nRln 79,384 dated 26 12 2014
Item of lmPort
Oty
1. ltem of Export
Qty
,kg
,~~~ETHYLENE DIAMINE TETRA
ACETIC ACID(EDTA)
0 410 k9
EDTA DIAMMONlUM
LIQUlD ASSAY MIN 40%
"em of mp●
蔵
Oty
1. ltem of ExPort
Qv
0 750 kg
mil」
明
AS Mg)
l kg
l TET贔財旨ぼ疋8::許→
A,,hO「zatiOn N0 0310ZV0001
Oly
…
Oty
0 420 kg
l kg
IT日晶1出港難|ド版ハ
儡蜃
92634 に
Qty
Oty
0 750 kg
4 kg
1遅‖き¶5置騨ヽに
'‐ …
EDTA TETRASOυ lUM
issues with the appoval oI competent authority'
Th S
知d愉話ξ
)齢慇t」
Tel N0 011-23381430
Deptt OF C&PCUO No
14010767′ 2011-CHJl daled
3092015

r 3 ___._-- -
Govemment of lndia 
/-' 
- ^ (
Ministry of Chemicals and Fertilizers ---/ 
,^ ^/o. 
'J "t '
Department of Chemicals and Petrochemicals )
Sublect:  Advance Authon2a“ On applcalon from M/s AVA Chemca:s Ltd forthe impo"of
raw matenal aga nst the export of  Disodium Manganese EDTA (Manganese
content 12 5%(+″ 050/O)
Ref:  UO No 01′ 82′050′864′AM‐ 13′DES‐‖
1′176 dated 23 6 2015
UO No 01′827050′572/AM‐ 16/DES‐‖
l′275 dated 1 7 2015
UO No 01′ 82/050′63′AM‐ 16/DES―‖
1′125 dated 16 6 2015
M/s AVA Chemicals Ltd have submitted present apprcaton fOr the import of raw
matena aga nst the export of  D sod um Manganese EDTA(Manganese content 12 5% (+′
05%)
The app cation has been examined and the Department recommends the fo‖
owing
no「msfo「the present Advance Author zation application
1. ltem of Export
Oty
Item of lmport
Qty
Disod um Manganese EDTA
(Manganese content 12 5%
(+″05%)
l kg
l  EDTA (Ethy ene Diamine
Tetra Aceuc Acid)
0 690 k9
豫Rヽヽf
(A K AGARwAL)
Addl lndustrial Adviser
Tel No 011-23381430
shn Mahender Vikram Singh FTDO(DESJIい0′o DGFT Udvoq Bhawan New Delh-11
Dept1 0f C&PC U O No 14010′ 67′ 2011‐CH Il dated   2 9 2015

Government of lndia
′δ
Dep』朧脇鼈
撚
=臥
1鳳icJs,もЧ。し
Sublecl:Advance AuthonzauOn app‖ ca10n from M′ s P I lndusthes Ltd forthe import of raw
maend aganョhe expon d PedOxa:::i織
Fgiよ曽‐
Cmoc.cydo"nメox,2
Fluo「ophenyり‐
5‐lsopropy idene-1,3 0xl
(Advance Autho12ation No 1310048016 dated 20 10 2013)
Ref:  UO No 01/82′ 50/01431′AM‐ 16DES‐3′ 1428dated ll o1 2016
agang鷺馳W?臨霞L嫌卍
:η‖」
:聰
Sed ap口饉“
Onお「
he mportof mw mae門J
‐(4-Chloro-5‐ Cyclopentyloxy_2-Fluorophenyl)_5‐
:sop「opy‖ dene‐ 1,3 0xazo‖ dine-2,4‐ Dione
The app“ catiOn has been examined allc」
l:1:epartment recommends the fo‖
owing
norms fOrthe present Advance Autho「12at On apF
1. ltem of Export
Qtv
kem oflmpon
Qty
Pentoxazone TechniciiSl
(4-Chloro-s-Cyclopentytoxy-
2-Fluorophenyl)-5-
lsopropylidene-1,3
Oxazolidine-2,4-Dione
l Kg
豚虎
lよξ搬牝蒻
2 095 kg
2. Toluene
0 435 kq
3. Ethyl chloro Formaie
0 644 kq
4. Cyclopentyl Bro;ide
1 095 ko
…
y‐3…
0 858 kq
This issue with the approval of competent authority.
(A K ACANWAL)
AddL Industrial Adviser
Tel No 011_23381430
h
Dept Of C&Pc U O No 15022/28′ 2012-CH‐ ‖dated o4 02 2016

´
1. Detailed manulacturing process, material balance with balanced chemical reactions
inoic"ting stage-wise piicentage yield along with the technical justificatioo enclosing
thlrewitli autientic printed technical literature in support of yield or quantity of items
for import.
2. Details of production of Sorbitan Mono Stearate and corresponding consumption of
raw materLls in the year 20'14-15 and 2015-'16 (April to September) duly certifled by
cA may be furnishe;. lf the production has not commenced in the past, the details
from commencement of production may be furnished duly certified by CA
3. Any other relevant information
イ1シ
You「s'a thfu‖ y,
い｀ムヽも
(A.K, AGAXWAL)
AddI lndustHal Adviser
Tel No 011‐23381430
C黎血稀棚:臓:::「l滞1瑞:闘1霜:躯:lfな‖
2露「
nce b DGFWUONo
F. No. 14010/10/2016-CH-ll
Government of lndia
Department of Chemicals and Petrochemicels
Chemical Division
Shast商Bhavan,New Delh‐ 110001
Dated: 11° February.2046
To,
M′s Moh n Organics P Ltd
210,Mahavi「lndI Estate,
Kachpada,Ramchandra Lane Extn,
Mabd(W),
Mumbai,Maharaqshtra400064
Sutte∝記
]‖鋼卵訃電亀肥laV認1:埋
ancS P Ц°お
rhe hp“ d mw‐
mate“J
,arate
(Advance AuthOrization No 0310799666 dated 20 10 2015)
i am direded to rerertO your Advance Autho薔za“on app‖ cation received from OfFce of
DGFT on above menuoned subleCt You are being adViSed to SubmRthe fo‖ owing infomatton
within 1 5 days of the lssue ofthis letter:

ハ
　
・
/3
1,-tt€
9'fi?'
t lclyog llh.rsan.\crr l)clhi.
I)atc(l thc 
\11r. ll)li
! t r ltc!. r\1 cn!!adr!!l
subiect: - Fi\.ltion ol l1or.rDs r.rndcr pi l-1.7 of tl |d Ilook ol Proccdures (vol.l) l(x)() Il ( trsc
oI M/s Satladc\ x Phirrnla l'\ I L1(1.
IheundersiSnedi:clitcctt'dtolcl'eltoDGIrlU.O.No.0l/SliiOillliA\l-l5l)lrSllili6
dnted t6c l2lll/14 !:ide *lliclr applicrrtion lioln M/s SulJ-adcvn Pha Da Pvt l-t(l \\as scrll lo this
l)cpaftnl!'[i lbr li\atior] ol' nomrs utldcr para: '1.7 lbr the cxP()n ol (2S)-(l-
'l ctrahl-tlropyramid-2-Onc)-3-Meth\ lbutlrnoic Acid ('l'PA) This dcparltncnt h;rs txanrinc':l
th" rloit". orr'l t5c lirll.riing.ornrs irrc lirrnishecl undcr para -1.7 (rl Hancl Bool' ol I)rrccll rcs
(Vol.l) 1009- l.l:-
l . No.l50l 1 6.17,110l.l-l)l (Nornrs)
( io\cflrn1cnl o,_ lndiit
Nlinisrrl ()l Chcrnicals & lreltilizcrs
I)cpa rn!'111 ol-Pharmacculiclls
L 
lhis isstlcs \\ith lhc apfro\al ol Diruclol (Pl)'
Ql). Rcconrnr.r)dc(l lS lg.
(1■lrndli Kha、1ビr)
Ulぅdc「SCCIctそlry tO tllc(lo、ヾIn]llcnt ol lnditi
l)1lollぜ:230ワ11て
'2
l)ireclorltle (ielteral ol' Iir|cigrt Traclc.
I )epaflr]rcnt ol (lotllmcr!c.
(Sh M.V. Sirrgh- lr llX)).
{ d)og l}hr\\nrr. Nc\\ l)clhi
lnrpolt ltcrtt
iヽ4ct11、lc1lc(1ぅlo itiぜ
い
1)1lit「
ヾ
\lcthr I ( hlolololrttitte

ヘ
F. No.350l l/t 7012014-pt (Norms)
Government oflndia
Ministry of Chemical & Fertili:rers
I)epartment of Pharmaceuticals
lldyog Bhawan.
New Delhi. the Octob€r- 2014
Ollice Memorandum
Suhiect: - F ixation of norms under para 4.7 of Hand tlook of procedures (Vol.l) 2009_14 Case
ot M/s Tiran Labs p\,1 Lld.
The undersigned is directcd to refer ro DCF'T U.O.No. 0l/82l50/943/A M_ l4lDFjS_
3/ L160 datcd the I 9/03/ l4 vide which application from M/s. Titan Labs pvt Ltd was sent ro this
Dcparlment lbr fixation of norms under para: 4.2 lor the expon ofOrlislrt pellcts S09/o. l.his
department has examined the matter and the following norms are fumished under pam 4.7 of
Hand Book ol'Procedures (Vol.l) 2009- l4:-
S. No.
I-
2.
lmpon Item
Qty. Recommended kg,&g.
()Hi●01
0505
Slarlac (Comound of Maize Slarch USp,Nl'.Ep and
l,actose Monohydrate [JSPnlt.EP)
Does not malch wilh control of
Materials t'umished hv firm.
Polyvinl- l pyrolidone K-30 (PVPK-3O
0.05
This issues with the approval ofDirector (Cost).
(Bamali Khastgir)
Under Secretary to the Govemment oflndia
Dircctomtc (;cncral of Foreign Trade,
Depanment ofCommerce.
(Shri M.V. Singh. FTDO),
tldyog Bhawan. New Delhi

/2
F No 14010′ 164′2011‐CH‐‖
Government ofind a
Dep器器∫
=翼
留
:S』F殿忠晶ユ
icJs
β力′。9′>
To,
Shiva Pharma Chem Ltd,
P ot No 588,
V‖l Luna TaI Padra,
Dist Baroda‐ 391440
SubleCt‐
tl羊ξ:馬11;ll♀li;::よtilli;1811lrthe mpOrtOfraw‐
matelJS agJnstthe export
ide′3-Chlo「Omethy Heptane
lAdv Autho12atiOn No 3410041663 dated 5 11 2015)
びDGFⅧ常鋼晶器|:鰐:舎:IこnT躍等群器:歯躙舗蟹
:」ぽ珈
寵
fo‖owing infonnation w thin 15 days ofthe issue ofthis letter
`
Detailed manufacturing process, material balanc€ with balanced chemical reactions
-nii""tino ti"o"-*i"" iercentage yieto along with the technical iustification enclosing
in"r"rit'ri ,rii""ti" printeo tec[niial literatu]e in support of yield or quantily of items
for import.
d;ii'" ; 
production of lsoctyl Chloride/2-Ethylhexyl Choride/3-chloromethyl
rl"oiin" "n,i 
corresponding consumption of raw materials in the year 2014-15 and
20i5-16 (Aprilto December) duly certifled by CA may be furntshed'
Any other relevant inlormation.
＾
∠
Shastri Bhavan,NeW Delhi‐ 110001
Dated: 11訥February.2016
lA K AGARWALl
Addl industrial Adviser
Tel No 011‐23381430
跡
`Mahender Vikram S ngh,FTDO(DES 3).h reFerence
to DGFT′ UO No‐
i tgztosotomoat eu- 16/DESItu'1452, dated 12.01.2016.

10
F No 14040149′ 2011‐CHJl
Government oflndia
Ministry Of Chem ca s and Fert‖
zers
Addl lndustr al Adviser
Tel No 011‐23381430
ユ
淵J篤∫鷺」鵠1:腿冊晶
『:減口
1:雷留
i:°
DGFフUO Nα
吻9■
Shast「Bhavan,New Delhi‐ 110001
Dated:1lh February,2016
To,
GULBRANDSONS CHEMICALS PVT LTD,
RECD OFF&FACT)ON COSTAL H:GHWAY,
VILL MU」PUR,TAL PADRA,
D:STT BAROEDA 391440
Sublectl― Advance AuthoHzalon App“ ca“on for the import of raw― matetta s against the expo■
of 30%DEZ in Toluene
lAdvanceAuthorizationsNo 3410041666Dated0911 2015)
l am directed to refer to your Advance AuthOrization apprcat on received through Office
of DGFT on the sublect menloned above ln this connection,yOu are requested to submn the
fol!owing information for export prOducts w thin 15 days ofthe issue ofthis letter
'1. Specific Chemical name, technical specification including percentage composition,
certificate of analysis for the item i.e. 30% DEZ in Toluene is to be exported.
2. Detailed manufacturing process, material balance with balanced chemical reactions
indicating stage-wise percentage yield along with the technical justification enclosing
therewith authentic printed technical literature in support of yield or quantity of items
for import.
3. Details of produclion of 30% DEZ in Toluene and corresponding consumption of raw
materials in the yeat 2014-15 and 20'15-16 (April to December) duly certified by CA
may be furnished. lf the production has not commenced in the past, the details from
commencement of production may be furnished duly certified by CA
4. Any other relevant information
Yours faithfully
(r \v('.

‐バ
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Fron
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To
Cc
BTrlU057420′ 2016‐PID
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Ni‖n Kumaruain DBTくnl nk,ain@nc n>
Flday Februalγ ,2,201610:498m
MahendraV kram S ngh FTDOくnc3 dgll@nC n>
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万
OFFICE MEMORAI{DUtI
Subiect Fixa'on ot lr. no.m3 undor para 4.07 of HBp, 201$20: application from /3 Sano Modicat Xits AA
Ltd., Chennai
The undersigned is direcred ro rcfer lo Drrecrorare Generar or Forergn Trade u.o. No. 01a2lo5o/01322AM-
1 6/DES-|lU 1 5,44 dared r 4.01 .201 6 forwardrng lhe apptication of M/s Sano Me;icar x irs pu ridl chennai tor ftxarion oI
?o N_orms ror the .xpori producls ca,ed -Fir;r Aid iiti e pru s piu ivio^ru;iJri;h; ;;;;;."n 
","mrned 
and the
DGFT is requested to seek jnformation on folowing poinis trom tne firm:
1 . Labels shou/ang conlents of each of the exporl products
I)ate: 1222016
This issues with approvat of the Compelenl Aulhority, Department of Baolechnology.
Sclentist・∈'
To
Sh■Mahendra Ⅵkram singh
Fore19n Trade Development Orcer(DES‐‖|)
O rectorate Cenera1 0r Fore gn Trade
M nislry Or Commerce&industry
Udyo9 Bhawan New De hi
(Nitin K lain)
＼
15‐02‐2016

入
Sub:
Sir,
F. No. 4(4)/2016-DGFT
Govemment of India
Ministry of Food Processing Industries
Panchsheel Bhawan, August Kranti Marg,
New Delhi-l10049
Datcd:05022016
0FFICE MEMORANDUM
Rcqucst fOr RatincatiOn or thc lnpu←Output Norms for Export OF Sun■ower Lccithin
Powder by M′ s Shiva B:ochcm lndustries,Amaravathi,Maharashtrn.
L Percentage purity ofimport item i.e. Sunflower Lecithin.
2. Percentage purity ofexpon products Sunflower Lecithin Powder and Sunflower Lecithin
Granules,
3. Detailed process of manufactures and process flow chart along with material balance at
each stage.
4. Justification for high wastage claimed.
5. Quantity of difTereni raw material consume (lmported or Indigenous) and corresponding
Quantity ofresultant products duly certified by Chartered Accountant for last three years.
6. Quantity and value of Export of Sunflower Lecithin Powder and Sunflower Lecithin
Granules for the last three years duly certified by Chartered Accountant.
Undcrsigncd has bccn dircctcd to rcFcr to DCFT UO No 01/82/Sα 1434/AM 167DES I‖ /1429
datcd‖ O12016 For duty frcc impo●
ofSunnower Lcchhn and Accttnc■弄manuracturc anoしxpor of
Sun00wcr Lccithin Powdcr and Sunf10wcr Lccithin Granulcs it is requcstcd to obtain following
infollllation to enablc this Ministry tO cxaminc thc proposal to rccOmmcnd suitablc input output norrns:‐
To
Dcputy lndustrial Advisor
Tcl:26406537
織I転
トイ
Shri Ratan Lal Mccna,
FTDO、
´
鴇DP-o--
ν

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Office of Directorate General of Foreign Trade New Delhi -110011

Para 4.7 Decision

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Office of Directorate General of Foreign Trade
New Delhi -110011