IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2015-10-15

DGFT Committee Minutes

Document text

Office of Directorate General of Foreign Trade
New Delhi -110011

Para 4.7 Decision

Meeting No. 10/82/2015 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 15.10.2015 under the Chairmanship of Dr. S.K. Bansal, Jt. DGFT in Room No.11, Udyog Bhawan, New Delhi.

Following members were present:-

Shri D.N. Mathur, Consultant, Department of Pharmaceutical Shri Nirmal Kumar, Dy.DGFT Shri Mahendra Vikram Singh, Foreign Trade Development Officer

The committee went through the minutes of earlier NC –III meeting No. 09/82 was scheduled for 30.09.2015 but actually held on 09.10.2015 and approved the same.

Note:

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

The following cases/issues were discussed and the committee took the decision as mentioned against each case.

MEETING NUMBER
: 10/82-ALC4/2015 MEETING DATE : 15.10.2015

Case No.:132/8/82-

ALC4/2014
Party Name:PROVENTUS LIFE SCIENCES PRIVATE LIMITED, Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00796/AM15/
RLA File :04/24/040/00395/AM08/
Lic.No/Date:0410094357 12.03.2008 Defer Date:18.11.2015 Decision : Information called for firm is awaited and deferred the case.

Case No.:353/5/82-

ALC4/2015
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00493/AM16/
RLA File :03/95/040/00130/AM11/
Lic.No/Date:0310575673 24.05.2010 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of comments of D/o C&PC(Petrochemical) .

Case No.:14/24/82-

ALC4/2010
Party Name:SAINOR LABORATORIES PVT LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File RLA File Lic.No/Date:0910043414 Defer

:01/82/050/00814/AM11/
:09/24/040/00210/AM11/
08.09.2010 Date:18.11.2015 Decision : It was decided to defer the case for want of comments of D/o C&PC(Chemicals).

Case No.:42/20/82-

ALC4/2013
Party Name:GLAND PHARMA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/01028/AM14/
RLA File :09/24/040/00058/AM14/
Lic.No/Date:0910056110 23.05.2013 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of comments of D/o Pharmaceuticals .

Case No.:173/5/82-

ALC4/2015
Party Name:FORACE POLYMERS (P) LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00313/AM16/
RLA File :05/23/040/00069/AM14/
Lic.No/Date:0510356983 13.06.2013 Defer Date: Decision : The Committee decided to ratify norms for the export product based on the recommendation of D/o C&PC forwarded vide O.M. No.46011/38/2015-PC dated 29.09.2015 , 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.:45/14/82-

ALC4/2013
Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, Meet No/Date:10/82- ALC4/2015 15.10.2015 Approved HQ File :01/82/050/00630/AM14/
RLA File :07/24/040/00137/AM14/
Lic.No/Date:0710097392 06.08.2013 Date:15.10.2015

Decision : The Committee decided to ratify norms for the export product Tenofovir Disoproxil fumarate based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/434/2015-PI (Norms) dated October.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.:43/16/82-

ALC4/2013
Party Name:SYMBIOTEC PHARMALAB LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00856/AM14/
RLA File :56/24/040/00017/AM14/
Lic.No/Date:5610002765 03.09.2013 Defer Date:18.11.2015 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. 35011/364/2014-PI (Norms) dated January, 2015, uploaded along with these minutes, decided to call for technical information from the firm and deferred the case.

Case No.:82/23/82-

ALC4/2013
Party Name:DEEPAK NITRITE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/01129/AM14/
RLA File :34/24/040/00212/AM14/
Lic.No/Date:3410038711 12.12.2013 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of comments of D/o C&PC(Chemicals)

9 Case No.:45/3/82- ALC4/2014
Party Name:AKZO NOBEL INDIA LIMITED Meet No/Date:10/82- ALC4/2015 Status:Case Deferred

15.10.2015 HQ File :01/82/050/00049/AM15/
RLA File :02/24/040/00168/AM13/
Lic.No/Date:0210198458 03.01.2014 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of comments of D/o C&PC(Chemicals)

Case No.:374/5/82-

ALC4/2015
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00514/AM16/
RLA File :03/95/040/01015/AM14/
Lic.No/Date:0310775114 20.03.2014 Defer Date:18.11.2015

Case No.:35/8/82-

ALC4/2014
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case

HQ File :01/82/050/00699/AM15/
RLA File :09/24/040/00639/AM14/
Lic.No/Date:0910059643 27.03.2014 Defer Date: Decision : The Committee decided to ratify norms for the export product 1,1-Cyclohexane diacetic Anhydride based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/253/2015-PI (Norms) dated Sept. 2015 , uploaded along with these minutes or as

Case No.:92/8/82-

ALC4/2015
Party Name:YASHASHVI RASAYAN PVT.LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00888/AM16/
RLA File :52/24/040/00055/AM14/
Lic.No/Date:5210040903 02.04.2014 Defer Date:15.10.2015 Decision : The Committee decided to ratify norms for the export product Thisa based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/36/2011-Ch-II dated 14.07. 2015,

Case No.:1/13/85-

ALC3/2014
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/85/050/00104/AM15/
RLA File :09/24/040/00007/AM15/
Lic.No/Date:0910059734 08.04.2014 Defer Date:18.11.2015 Decision: Committee considered the case as per agend and decided to advise the firm to chek the ITCHS code of export product.

Case No.:53/5/82-

ALC4/2014
Party Name:UNIMAX CHEMICALS PVT LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status: Approved HQ File :01/82/050/00370/AM15/
RLA File :03/95/040/00015/AM15/
Lic.No/Date:0310779156 23.04.2014 Defer Date:15.10.2015 Decision : It was decided to defer the case for want of comments of DoP .

Case No.:1/9/85-

ALC3/2014
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred

HQ File :01/85/050/00067/AM15/
RLA File :09/24/040/00049/AM15/
Lic.No/Date:0910059919 28.04.2014 Defer Date:18.11.2015 Decision : Committee considered the case as per agend and decided to advise the firm to chek the ITCHS code of export product.

Case No.:76/10/82-

ALC4/2014
Party Name:KUDOS CHEMIE LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00990/AM15/
RLA File :22/24/040/00099/AM14/
Lic.No/Date:2210014839 29.04.2014 Defer Date:18.11.2015 Decision : : It was decided to defer the case for want of comments of DoP .

Case No.:57/5/82-

ALC4/2014
Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00374/AM15/
RLA File :03/95/040/00085/AM15/
Lic.No/Date:0310780627 05.05.2014 Defer Date:15.10.2015 recommendation of D/o C&PCs forwarded vide U.O.No.14010/13/2012-Ch-II dated 5.10.2015 ,

Case No.:238/6/82-

ALC4/2014
Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : It was decided to defer the case for want of comments of DC&PC(Petrochemical).

Case No.:383/5/82-

ALC4/2015
Party Name:DR REDDYS LABORATORIES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Deferred HQ File :01/82/050/00523/AM16/
RLA File :09/24/040/00019/AM15/
Lic.No/Date:0910060081 13.05.2014 Defer Date: Decision : It was decided to defer the case for want of comments of DoP.

Case No.:14/5/82-

ALC4/2015
Party Name:YASHASHVI RASAYAN PVT.LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00154/AM16/
RLA File :52/24/040/00009/AM15/
Lic.No/Date:5210041040 13.05.2014 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of comments of DC&PC.

Case No.:15/5/82-

ALC4/2015
Party Name:ASCENT FINECHEM PVT. LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00155/AM16/
RLA File :08/24/040/00055/AM15/
Lic.No/Date:0810131405 19.05.2014 Defer Date:18.11.2015

Case No.:88/6/82-

ALC4/2014
Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

Case No.:9/10/82-

ALC4/2014
Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00923/AM15/
RLA File :31/83/040/00032/AM15/
Lic.No/Date:3110064004 21.05.2014 Defer Date:18.11.2015 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. 35011/638/2014-PI (Norms) dt. 06.10.2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

Case No.:1/3/82-

ALC4/2015
Party Name:BALAJI AMINES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00031/AM16/
RLA File :31/83/040/00006/AM15/
Lic.No/Date:3110064305 05.06.2014 Defer Date:15.10.2015 Decision : The Committee decided to ratify norms for the export product Gama Butyrolactone based on the recommendation of D/o Pharmaceuticals forwarded vide U.O. No.14010/122/2011- Ch-II dated 05.10.2015 , 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.:61/4/82-

ALC4/2014
Party Name:V & V PHARMA INDUSTRIES Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

Case No.:364/5/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00504/AM16/
RLA File :09/24/040/00124/AM15/
Lic.No/Date:0910060469 17.06.2014 Defer Date: Decision : The Committee decided to ratify norms for the export product based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/276/2015-PI(Norms) dated 01.09. 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.:164/6/82-

ALC4/2014
Party Name:VDH CHEM TECH PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00566/AM15/
RLA File :05/24/040/00085/AM15/
Lic.No/Date:0510388792 18.06.2014 Defer Date:18.11.2015

Case No.:170/6/82-

ALC4/2014
Party Name:SOFTGEL HEALTH CARE PVT. LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00572/AM15/
RLA File :04/24/040/00032/AM15/
Lic.No/Date:0410158822 24.06.2014 Defer Date:18.11.2015

Case No.:69/4/82-

ALC4/2014
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

Case No.:73/9/82-

ALC4/2014
Party Name:D. R. COATS INK & RESINS PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

Case No.:204/6/82-

ALC4/2014
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00606/AM15/
RLA File :05/24/040/00192/AM14/
Lic.No/Date:0510389448 08.07.2014 Defer Date: recommendation of D/o C&PC forwarded vide U.O.No.14010/18/2014-Ch-II dated 02.09.2015 ,

Case No.:211/6/82-

ALC4/2014
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00613/AM15/
RLA File :05/24/040/00191/AM14/
Lic.No/Date:0510389447 08.07.2014 Defer Date: recommendation of D/o C&PC forwarded vide U.O.No.14010/18/2014-Ch-II dated 02.09.2015 ,

Case No.:370/5/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

Case No.:26/9/82-

ALC4/2014
Party Name:ALMELO PVT LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved

HQ File :01/82/050/00823/AM15/
RLA File :09/24/040/00188/AM15/
Lic.No/Date:0910060660 11.07.2014 Defer Date: Decision : The Committee decided to ratify norms for the export product Oxo-Erythronolide A- 11,12-Carbamate based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/604/2014-PI(Norms) dated 05.10.2015 , uploaded along with these minutes or as

Case No.:375/5/82-

ALC4/2015
Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00515/AM16/
RLA File :22/24/040/00023/AM15/
Lic.No/Date:2210015018 12.07.2014 Defer Date: Decision : The Committee decided to ratify norms for the export product Cefoperazone sodium Sterile based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/284/2015-PI(Norms) dated 07.10.2015 , uploaded along with these minutes or as

3 6

Case No.:88/9/82-

ALC4/2014
Party Name:MAC CHEM PRODUCTS (INDIA) PRI VATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Cas e Deferred HQ File :01/82/050/00885/ AM15/
RLA File :03/95/040/00302/AM15/
Lic.No/Date:03107 86782 14.07.2014 Defer Date:18.11. 2015 Decision : Information called for firm in the meeting no. 3/82 AM16 (minutes uploaded) is awaited. The case was deferred.

Case No.:365/5/82-

ALC4/2015
Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00505/AM16/
RLA File :22/24/040/00028/AM15/
Lic.No/Date:2210015020 15.07.2014 Defer Date: Decision : The Committee decided to ratify norms for the export product Cephalothin for injection based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/283/2015- PI(Norms) dated 07.10.2015 , 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.:108/9/82-

ALC4/2014
Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00905/AM15/
RLA File :22/24/040/00083/AM14/
Lic.No/Date:2210015019 15.07.2014 Defer Date:18.11.2015 Decision : Information called for firm in the meeting no. 19/82 AM 14 & 3/82 AM16 (minutes uploaded) is awaited. The case was deferred.

Case No.:94/5/82-

ALC4/2015
Party Name:SHREE BANKEY BEHARI LAL BOARD MILLS Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred

HQ File :01/82/050/00234/AM16/
RLA File :05/24/040/00126/AM15/
Lic.No/Date:0510389737 16.07.2014 Defer Date:18.11.2015

Case No.:248/13/82-

ALC4/2014
Party Name:REANNON PHARMACEUTICALS Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/01251/AM15/
RLA File :03/95/040/00325/AM15/
Lic.No/Date:0310786993 17.07.2014 Defer Date:18.11.2015 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. 35011/120/2015-PI(Norms) dt.30.09.2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

Case No.:1/6/82-

ALC4/2014
Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00403/AM15/
RLA File :04/24/040/00061/AM15/
Lic.No/Date:0410159021 18.07.2014 Defer Date:18.11.2015 Decision : It was decided to send a copy of application to D/o pharmaceuticals.

Case No.:79/9/82-

ALC4/2014
Party Name:METROPOLITAN EXIMCHEM LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00876/AM15/
RLA File :03/95/040/00337/AM15/
Lic.No/Date:0310787073 18.07.2014 Defer Date:18.11.2015

Case No.:24/9/82-

ALC4/2014
Party Name:BRUNDAVAN LABORATORIES PRIVATE LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00821/AM15/
RLA File :09/24/040/00104/AM15/
Lic.No/Date:0910060703 22.07.2014 Defer Date:18.11.2015

Case No.:78/9/82-

ALC4/2014
Party Name:PACE PHARMATECH PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00875/AM15/
RLA File :03/95/040/00347/AM15/
Lic.No/Date:0310787160 22.07.2014 Defer Date:18.11.2015 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. 35011/583/2014-PI(Norms) dt.09.03.2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

Case No.:396/5/82-

ALC4/2015
Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

Decision : It was decided to defer the case for want of comments of DC&PC(Petrochemical).

Case No.:8/6/82-

ALC4/2014
Party Name:V & V PHARMA INDUSTRIES Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

Case No.:209/13/82-

ALC4/2014
Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/01212/AM15/
RLA File :03/94/040/00379/AM15/
Lic.No/Date:0310787473 31.07.2014 Defer Date:18.11.2015 Decision : Information called for firm is awaited and hence it was decieded to deferred the case.

Case No.:58/9/82-

ALC4/2014
Party Name:G AMPHRAY LABORATORIES, Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : It was decided to send a copy of application to DoP.

Case No.:49/9/82-

ALC4/2014
Party Name:SANMAR SPECIALITY CHEMICALS LIMITED, Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

Case No.:31/9/82-

ALC4/2014
Party Name:AMBERNATH ORGANICS PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

Case No.:44/9/82-

ALC4/2014
Party Name:INTAS PHARMACEUTICALS LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00841/AM15/
RLA File :08/24/040/00173/AM15/
Lic.No/Date:0810132883 04.08.2014 Defer Date:18.11.2015 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. 35011/57/2015-PI(Norms) dt. Sept. 2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

Case No.:373/5/82-

ALC4/2015
Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred

HQ File :01/82/050/00513/AM16/
RLA File :22/24/040/00039/AM15/
Lic.No/Date:2210015055 06.08.2014 Defer Date:18.11.2015

Case No.:203/5/82-

ALC4/2015
Party Name:ALKALOIDS CORPORATION Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00343/AM16/
RLA File :02/24/040/00080/AM15/
Lic.No/Date:0210204732 07.08.2014 Defer Date:18.11.2015

Case No.:42/13/82-

ALC4/2014
Party Name:INCHEM LABORATORIES PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/01045/AM15/
RLA File :09/24/040/00242/AM15/
Lic.No/Date:0910060833 07.08.2014 Defer Date: Decision : The Committee decided to ratify norms for the export product Ractopamine Hcl based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/105/2015- PI(Norms) dated 07.10.2015 , 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.:105/9/82-

ALC4/2014
Party Name:SCOTT-EDIL PHARMACIA LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00902/AM15/
RLA File :22/24/040/00035/AM15/
Lic.No/Date:2210015058 07.08.2014 Defer Date:18.11.2015 Decision : Information called for from the firm is awaited and deferred the case.

Case No.:53/9/82-

ALC4/2014
Party Name:ONEIRO CHEMICALS LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00850/AM15/
RLA File :34/24/040/00111/AM15/
Lic.No/Date:3410040436 11.08.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/282/2015-PI(Norms) dated 07.10.2015 , uploaded along with these minutes or as applied by the firm whichever is less

Case No.:8/9/82-

ALC4/2014
Party Name:RANBAXY LABORATORIES LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00805/AM15/
RLA File :05/24/040/00202/AM15/
Lic.No/Date:0510390250 11.08.2014 Defer Date: Decision : The Committee decided to ratify norms for the export product Meropenem Sterile based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/252/2015- PI(Norms) dated 01.10.2015 , 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.:93/9/82-

ALC4/2014
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00890/AM15/
RLA File :03/95/040/00412/AM15/
Lic.No/Date:0310787910 11.08.2014 Defer Date:15.10.2015 recommendation of DC&PCs forwarded vide U.O.No.14010/95/2011-Ch-II dated 11.09.2015 ,

Case No.:23/9/82-

ALC4/2014
Party Name:BIO-TECH OPHTHALMICS PVT. LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00820/AM15/
RLA File :08/24/040/00176/AM15/
Lic.No/Date:0810132955 12.08.2014 Defer Date:18.11.2015 Decision :Information called for from the firm is awaited and deferred the case.

Case No.:21/9/82-

ALC4/2014
Party Name:PI INDUSTRIES LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status: Approved HQ File :01/82/050/00818/AM15/
RLA File :13/24/040/00020/AM15/
Lic.No/Date:1310047575 12.08.2014 Defer Date:15.10.2015 Decision : The Committee decided to ratify norms for the export product Ethyl 4-Chloro-2-Fluoro- 5 based on the recommendation of DC&PCs forwarded vide U.O.No.15022/6/2010-Ch-II dated 10.03.2015 , 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.:211/13/82-

ALC4/2014
Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/01214/AM15/
RLA File :03/94/040/00423/AM15/
Lic.No/Date:0310788032 14.08.2014 Defer Date:15.10.2015 Decision : The Committee decided to ratify norms for the export product EDTA based on the recommendation of D/o C&PC, forwarded vide U.O. No.14010/67/2011-Ch-II dated 30.09.2015 ,

Case No.:48/5/82-

ALC4/2015
Party Name:VISION DRUGS PVT LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

Case No.:378/5/82-

ALC4/2015
Party Name:CATAPHARMA CHEMICALS PVT. LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00518/AM16/
RLA File :31/83/040/00115/AM15/
Lic.No/Date:3110064753 19.08.2014 Defer Date:18.11.2015

Decision : The Committee considered the case for ratification of norms as per agenda. Since the export product and import item has same description and chemical compound, the committee decided that while fixing wastage it is necessary to specify the purity of export and import items in the comments of each case. DC&PC may accordingly furnish revised recommendations. The committee accordingly decided to defer the case.

Case No.:60/13/82-

ALC4/2014
Party Name:VERDANT LIFE SCIENCES PVT LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/01063/AM15/
RLA File :09/24/040/00238/AM15/
Lic.No/Date:0910060869 20.08.2014 Defer Date: Decision : The Committee decided to ratify norms for the export product Carisoprodol based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/176/2015-PI(Norms) dated 1.10.2015, uploaded along with these minutes or as applied by the firm whichever is less

Case No.:240/5/82-

ALC4/2015
Party Name:VIC INDUSTRIES, Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00380/AM16/
RLA File :17/24/040/00054/AM15/
Lic.No/Date:1710005896 22.08.2014 Defer Date:18.11.2015 Decision : Information called for from the firm is awaited and deferred the case.

Case No.:229/13/82-

ALC4/2014
Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/01232/AM15/
RLA File :03/94/040/00465/AM15/
Lic.No/Date:0310788333 25.08.2014 Date:15.10.2015 Decision : The Committee decided to ratify norms for the export product Disodium Megnesuim based on the recommendation of D/o C&PC, forwarded vide U.O. No.14010/67/2011-Ch-II dated 30.09.2015 , 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.:215/13/82-

ALC4/2014
Party Name:GOLD STAR CHEMICALS PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : It was decided to defer the case for want of comments of D/o C&PC(Chemicals)

Case No.:45/13/82-

ALC4/2014
Party Name:HETERO DRUGS LIMITED, Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/01048/AM15/
RLA File :09/24/040/00275/AM15/
Lic.No/Date:0910060885 25.08.2014 Defer Date:18.11.2015 Decision : Information called for from the firm is awaited and deferred the case.

Case No.:264/13/82-

ALC4/2014
Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

Case No.:42/9/82-

ALC4/2014
Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00839/AM15/
RLA File :08/24/040/00197/AM15/
Lic.No/Date:0810133103 26.08.2014 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of comments of DoP.

Case No.:255/13/82-

ALC4/2014
Party Name:THE DHARAMSI MORARJI CHEMICAL CO LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

Case No.:382/5/82-

ALC4/2015
Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00522/AM16/
RLA File :34/24/040/00129/AM15/
Lic.No/Date:3410040491 27.08.2014 Defer Date:18.11.2015

Case No.:377/5/82-

ALC4/2015
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

Case No.:43/9/82-

ALC4/2014
Party Name:SARV BIO LABS PVT.LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00840/AM15/
RLA File :05/24/040/00203/AM15/
Lic.No/Date:0510390783 27.08.2014 Defer Date:18.11.2015

Case No.:456/5/82-

ALC4/2015
Party Name:CLARION DRUGS LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00596/AM16/
RLA File :50/24/040/00006/AM15/
Lic.No/Date:5010002152 28.08.2014 Defer Date:18.11.2015

Case No.:224/13/82-

ALC4/2014
Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File RLA File Lic.No/Date:0310788515 Defer

:01/82/050/01227/AM15/
:03/94/040/00391/AM15/
28.08.2014 Date:18.11.2015

Case No.:225/13/82-

ALC4/2014
Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

Case No.:256/13/82-

ALC4/2014
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/01259/AM15/
RLA File :03/95/040/00371/AM15/
Lic.No/Date:0310788509 28.08.2014 Defer Date:18.11.2015

Case No.:262/13/82-

ALC4/2014
Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

Case No.:263/13/82-

ALC4/2014
Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

Case No.:223/13/82-

ALC4/2014
Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

Case No.:3/7/82-

ALC4/2014
Party Name:S V CHEM INTERMEDIATES P LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

Case No.:75/9/82-

ALC4/2014
Party Name:NEUTEC HEALTHCARE (P) LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File RLA File Lic.No/Date:0510390973 Defer

:01/82/050/00872/AM15/
:05/24/040/00235/AM15/
04.09.2014 Date:18.11.2015

Case No.:401/5/82-

ALC4/2015
Party Name:ONEIRO CHEMICALS LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00541/AM16/
RLA File :34/24/040/00141/AM15/
Lic.No/Date:3410040510 04.09.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/282/2015-PI(Norms) dated 07.10.2015 , uploaded along with these minutes or as applied by the firm whichever is less

Case No.:71/13/82-

ALC4/2014
Party Name:INCHEM LABORATORIES PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/01074/AM15/
RLA File :09/24/040/00313/AM15/
Lic.No/Date:0910060931 10.09.2014 Defer Date: Decision : The Committee decided to ratify norms for the export product Ractopamine Hcl based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/105/2015- PI(Norms) dated 07.10.2015 , 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.:81/5/82-

ALC4/2015
Party Name:RUCHI INFRASTRUCTURE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00221/AM16/
RLA File :56/24/040/00034/AM15/
Lic.No/Date:5610004407 15.09.2014 Defer Date:18.11.2015 Decision :Information called for from the firm is awaited accordingly decided to defer the case.

87 Case No.:65/13/82- ALC4/2014
Party Name:MSN LABORATORIES PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/01068/AM15/
RLA File :09/24/040/00283/AM15/
Lic.No/Date:0910060955 12.09.2014 Defer Date: Decision :This case has already been approved in NC 09/AM16 dt. 30.09.2015.

Case No.:391/5/82-

ALC4/2015
Party Name:TIDE INDUSTRIES Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00531/AM16/
RLA File :34/24/040/00138/AM15/
Lic.No/Date:3410040551 15.09.2014 Defer Date:18.11.2015 Decision : Information called for from the firm is awaited accordingly decided to defer the case.

Case No.:398/5/82-

ALC4/2015
Party Name:YASH RASAYAN & CHEMICALS Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00538/AM16/
RLA File :34/24/040/00122/AM15/
Lic.No/Date:3410040555 15.09.2014 Defer Date:

recommendation of D/o C&PC, forwarded vide U.O. No.14010/42/2015-Ch-II dated 7.10.2015 ,

Case No.:400/5/82-

ALC4/2015
Party Name:YASH RASAYAN & CHEMICALS Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

Case No.:12/15/82-

ALC4/2014
Party Name:JINDAL DRUGS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : It was decided to defer the case for want of comments of DC&PC(Petrochemicals)

Case No.:380/5/82-

ALC4/2015
Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

Case No.:399/5/82-

ALC4/2015
Party Name:ALCHEM INTERNATIONAL LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00539/AM16/
RLA File :05/23/040/00235/AM15/
Lic.No/Date:0510391191 18.09.2014 Defer Date:18.11.2015 Decision : Information called for firm in the meeting no. 5/82 AM16 (minutes uploaded) is awaited. The case was deferred.

Case No.:381/5/82-

ALC4/2015
Party Name:ASCENT FINECHEM PVT. LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00521/AM16/
RLA File :08/24/040/00207/AM15/
Lic.No/Date:0810133388 19.09.2014 Defer Date:18.11.2015

Case No.:390/5/82-

ALC4/2015
Party Name:ATUL LIMITED, Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00530/AM16/
RLA File :08/24/040/00225/AM15/
Lic.No/Date:0810133394 19.09.2014 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of comments of DC&PC(Petrochemicals).

96 Case No.:376/5/82- Party Meet No/Date:10/82- Status:Case

ALC4/2015
Name:R.K.INDUSTRIES, ALC4/2015 15.10.2015 Approved HQ File :01/82/050/00516/AM16/
RLA File :08/24/040/00231/AM15/
Lic.No/Date:0810133412 23.09.2014 Defer Date: Decision : The Committee decided to ratify norms for the export product based on the recommendation of D/o C&PC, forwarded vide U.O. No.14010/71/2013-Ch-II dated 06.10.2015 ,

97 Case No.:59/13/82- ALC4/2014
Party Name:HELLO PAINTS (P) LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision :The committee considered the case and deferred the case for want of comments from D/o C&PC(Chemicals)

Case No.:49/5/82-

ALC4/2015
Party Name:VISION DRUGS PVT LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00189/AM16/
RLA File :09/24/040/00336/AM15/
Lic.No/Date:0910061013 23.09.2014 Defer Date:18.11.2015

Case No.:176/13/82-

ALC4/2014
Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/01179/AM15/
RLA File :03/94/040/00361/AM15/
Lic.No/Date:0310789985 07.10.2014 Defer Date: 27.11.2015

100

Case No.:179/13/82-

ALC4/2014
Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/01182/AM15/ RLA File :03/94/040/00622/AM15/ Lic.No/Date:0310790000 08.10.2014 Defer Date:15.10.2015 Decision : The Committee decided to ratify norms for the export product EDTA Diammonium based on the recommendation of D/o C&PC, forwarded vide U.O. No.14010/67/2011-Ch-II dated 30.09.2015 , uploaded along with these minutes or as applied by the firm whichever is less

101

Case No.:372/5/82-

ALC4/2015
Party Name:DR J PHARMACHEM (INDIA)(PROP.ADITYA PRAMOD JOGDEO) Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

102

Case No.:29/13/82-

ALC4/2014
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/01032/AM15/ RLA File :05/23/040/00268/AM15/ Lic.No/Date:0510391490 08.10.2014 Defer Date:18.11.2015

103

Case No.:356/5/82-

ALC4/2015
Party Name:GLAND PHARMA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00496/AM16/ RLA File :09/24/040/00350/AM15/ Lic.No/Date:0910061069 09.10.2014 Defer Date:18.11.2015

104

Case No.:350/5/82-

ALC4/2015
Party Name:AMBE PHYTOEXTRACTS PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00490/AM16/ RLA File :05/23/040/00238/AM15/ Lic.No/Date:0510391555 13.10.2014 Defer Date:18.11.2015

105

Case No.:124/5/82-

ALC4/2015
Party Name:DORF- KETAL CHEMICALS INDIA PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00264/AM16/ RLA File :03/94/040/00684/AM15/ Lic.No/Date:0310790248 14.10.2014 Defer Date:15.10.2015 Decision : The Committee decided to ratify norms for the export product Calcium Removal Agent Sr.8104 based on the recommendation of D/o C&PC, forwarded vide U.O. No.14010/176/2011-Ch-II dated 20.10.2015 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.

106

Case No.:384/5/82-

ALC4/2015
Party Name:SATYADEVA PHARMACEUTICALS /P/ LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00524/AM16/
RLA File :09/24/040/00382/AM15/
Lic.No/Date:0910061123 20.10.2014 Defer Date: Decision : The Committee decided to ratify norms for the export product N-(N-Methyl-N-(2- Isopropyl… based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/409/2015-PI(Norms) dated 29.09.2015 uploaded along with these minutes or as

107

Case No.:125/5/82-

ALC4/2015
Party Name:DORF- KETAL CHEMICALS INDIA PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00265/AM16/ RLA File :03/94/040/00605/AM15/ Lic.No/Date:0310790441 21.10.2014 Defer Date:15.10.2015

recommendation of D/o C&PC, forwarded vide U.O. No.14010/176/2011-Ch-II dated 20.10.2015 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.

108

Case No.:352/5/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00492/AM16/ RLA File :09/24/040/00398/AM15/ Lic.No/Date:0910061128 22.10.2014 Defer Date:18.11.2015 Decision : The Committee decided to ratify norms for the export product Reversacol Pennine Green based on the recommendation of DC&PCs forwarded vide U.O.No.14010/138/2011-Ch-II dated 19.09.2015 , uploaded along with these minutes or as applied by the firm whichever is NC.

109

Case No.:1/19/85-

ALC3/2014
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/85/050/00156/AM15/
RLA File :09/24/040/00411/AM15/
Lic.No/Date:0910061136 27.10.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/223/2015-PI(Norms) dated 11.09.2015, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. However, ITCHS code of export product need to be corrected by the firm. RA concerned may take necessary action as per decision of NC.

110

Case No.:387/5/82-

ALC4/2015
Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00527/AM16/
RLA File :09/24/040/00412/AM15/
Lic.No/Date:0910061152 29.10.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/420/2015-PI(Norms) dated October.2015 , uploaded along with these minutes or as applied by the firm whichever is NC.

111 Case No.:171/13/82- ALC4/2014
Party Name:PRASOL CHEMICALS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/01174/AM15/ RLA File :03/95/040/00588/AM15/ Lic.No/Date:0310790482 22.10.2014 Defer Date:18.11.2015 Decision :it was decided to defer the case for want of comments of D/o C&PC(Chemicals)

112

Case No.:70/18/82-

ALC4/2014
Party Name:GLENMARK GENERICS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/01436/AM15/
RLA File :03/94/040/00557/AM15/
Lic.No/Date:0310790636 30.10.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/66/2015-PI(Norms)

dated September 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.

113

Case No.:388/5/82-

ALC4/2015
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00528/AM16/ RLA File :09/24/040/00396/AM15/ Lic.No/Date:0910061183 05.11.2014 Defer Date:18.11.2015 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. No.35011/102/2014-PI(Norms) dt. October 2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

114

Case No.:1/13/82-

ALC4/2014
Party Name:HETERO LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/01004/AM15/
RLA File :09/24/040/00417/AM15/
Lic.No/Date:0910061188 07.11.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/406/2015-PI(Norms) dated September 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.

115

Case No.:359/5/82-

ALC4/2015
Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00499/AM16/ RLA File :22/24/040/00067/AM15/ Lic.No/Date:2210015119 10.11.2014 Defer Date:18.11.2015 Decision :It was decided to defer the case for want of comments of DoP.

116

Case No.:358/5/82-

ALC4/2015
Party Name:SHEETAL CHEMICALS PVT LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00498/AM16/
RLA File :09/24/040/00422/AM15/
Lic.No/Date:0910061196 10.11.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/286/2015-PI(Norms) dated 07.10. 2015 , uploaded along with these minutes or as applied by the firm whichever is NC.

117

Case No.:393/5/82-

ALC4/2015
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision :It was decided to defer the case for want of comments of DoP.

118 Case No.:198/5/82- ALC4/2015
Party Name:SHASUN PHARMACEUTICALS Meet No/Date:10/82- ALC4/2015 Status:Case Deferred

LIMITED 15.10.2015 HQ File :01/82/050/00338/AM16/ RLA File :04/24/040/00205/AM15/ Lic.No/Date:0410159704 11.11.2014 Defer Date:18.11.2015

119

Case No.:392/5/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00532/AM16/ RLA File :09/24/040/00405/AM15/ Lic.No/Date:0910061222 13.11.2014 Defer Date:18.11.2015

120

Case No.:126/8/82-

ALC4/2015
Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

121

Case No.:129/5/82-

ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00269/AM16/ RLA File :03/94/040/00740/AM15/ Lic.No/Date:0310791183 18.11.2014 Defer Date:18.11.2015

122

Case No.:366/5/82-

ALC4/2015
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00506/AM16/
RLA File :09/24/040/00424/AM15/
Lic.No/Date:0910061281 20.11.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/422/2015-PI(Norms) dated October 2015 , uploaded along with these minutes or as applied by the firm whichever is NC.

123

Case No.:371/5/82-

ALC4/2015
Party Name:MYLAN Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00511/AM16/
RLA File :09/24/040/00463/AM15/
Lic.No/Date:0910061295 24.11.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/423/2015-PI(Norms) dated 8th October 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.

124

Case No.:357/5/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved

HQ File :01/82/050/00497/AM16/
RLA File :09/24/040/00435/AM15/
Lic.No/Date:0910061305 25.11.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/276/2015-PI(Norms) dated 1.09.2015 , uploaded along with these minutes or as applied by the firm whichever is less

125

Case No.:355/5/82-

ALC4/2015
Party Name:GRANULES INDIA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision :It was decided to defer the case for want of comments of D/o C&PC(Chemicals)

126

Case No.:94/13/82-

ALC4/2014
Party Name:HETERO DRUGS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. No.35011/143/2015-PI(Norms) dt. October 2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

127

Case No.:367/5/82-

ALC4/2015
Party Name:MYLAN Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00507/AM16/
RLA File :09/24/040/00476/AM15/
Lic.No/Date:0910061308 25.11.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/421/2015-PI(Norms) dated October 2015 , uploaded along with these minutes or as applied by the firm whichever is NC.

128

Case No.:126/5/82-

ALC4/2015
Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00266/AM16/ RLA File :22/24/040/00074/AM15/ Lic.No/Date:2210015136 28.11.2014 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of comments of DoP

129

Case No.:362/5/82-

ALC4/2015
Party Name:KLJ PLASTICIZERS LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : It was decided to defer the case for want of comments of DC&PC.

130 Case No.:247/5/82- ALC4/2015
Party Name:SHREEGEN PHARMA LTD Meet No/Date:10/82- ALC4/2015 Status:Case Deferred

15.10.2015 HQ File :01/82/050/00387/AM16/ RLA File :09/24/040/00467/AM15/ Lic.No/Date:0910061323 28.11.2014 Defer Date:18.11.2015

131

Case No.:257/5/82-

ALC4/2015
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00397/AM16/ RLA File :03/95/040/00706/AM15/ Lic.No/Date:0310791534 28.11.2014 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of comments of DC&PC(Petrochemicals).

132

Case No.:360/5/82-

ALC4/2015
Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00500/AM16/
RLA File :05/23/040/00386/AM15/
Lic.No/Date:0510392229 01.12.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/224/2015-PI(Norms) dated 29.09.2015 , uploaded along with these minutes or as applied by the firm whichever is NC.

133

Case No.:361/5/82-

ALC4/2015
Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00501/AM16/
RLA File :05/23/040/00380/AM15/
Lic.No/Date:0510392228 01.12.2014 Defer Date: Decision : The Committee decided to ratify norms for the export product Tan-Endo Powder based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/224/2015- PI(Norms) dated 29.09.2015 , 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.

134

Case No.:245/5/82-

ALC4/2015
Party Name:GLAND PHARMA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00385/AM16/ RLA File :09/24/040/00470/AM15/ Lic.No/Date:0910061327 02.12.2014 Defer Date:18.11.2015

135

Case No.:264/5/82-

ALC4/2015
Party Name:GLAND PHARMA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00404/AM16/ RLA File :09/24/040/00471/AM15/ Lic.No/Date:0910061328 02.12.2014 Defer Date:18.11.2015

136

Case No.:128/5/82-

ALC4/2015
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred

HQ File :01/82/050/00268/AM16/ RLA File :03/95/040/00733/AM15/ Lic.No/Date:0310791625 02.12.2014 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of comments of D/o C&PC(Petrochemicals)

137

Case No.:68/18/82-

ALC4/2014
Party Name:CROWN CHEMICALS PVT.LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/01434/AM15/ RLA File :03/94/040/00838/AM15/ Lic.No/Date:0310791657 03.12.2014 Defer Date:18.11.2015

138

Case No.:50/5/82-

ALC4/2015
Party Name:RAJ PIONEER LABORATORIES INDIA PRIVATE LIMITED, Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00190/AM16/
RLA File :56/24/040/00040/AM15/
Lic.No/Date:5610004489 03.12.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/414/2015-PI(Norms) dated 07.10.2015 , uploaded along with these minutes or as applied by the firm whichever is NC.

13 9

Case No.:261/5/82-

ALC4/2015
Party Name:SMILAX LABORATORIES LI MITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00401/A M16/
RLA File :09/24/040/00493/AM15/
Lic.No/Date:0910061 345 04.12.2014 Defer Date:18.11.20 15

140

Case No.:207/5/82-

ALC4/2015
Party Name:SRINI PHARMACEUTICALS LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00347/AM16/ RLA File :09/24/040/00474/AM15/ Lic.No/Date:0910061343 04.12.2014 Defer Date:18.11.2015

141

Case No.:385/5/82-

ALC4/2015
Party Name:AMI ORGANICS PVT LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00525/AM16/ RLA File :52/24/040/00044/AM15/ Lic.No/Date:5210041339 05.12.2014 Defer Date:18.11.2015

142

Case No.:154/5/82-

ALC4/2015
Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

143

Case No.:265/5/82-

ALC4/2015
SCIENCES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00405/AM16/
RLA File :09/24/040/00479/AM15/
Lic.No/Date:0910061351 05.12.2014 Defer Date: Decision : The Committee decided to ratify norms for the export product Methyl (E) based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/538/2013-PI(Norms) dated 26.09.2013 , uploaded along with these minutes or as applied by the firm whichever is NC.

144

Case No.:244/5/82-

ALC4/2015
Party Name:VIVIN LABORATORIES PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00384/AM16/ RLA File :09/24/040/00420/AM15/ Lic.No/Date:0910061353 05.12.2014 Defer Date:18.11.2015

145

Case No.:248/5/82-

ALC4/2015
Party Name:VIVIN LABORATORIES PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00388/AM16/ RLA File :09/24/040/00483/AM15/ Lic.No/Date:0910061354 05.12.2014 Defer Date:18.11.2015

146

Case No.:280/13/82-

ALC4/2014
Party Name:HETERO LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/01283/AM15/
RLA File :09/24/040/00498/AM15/
Lic.No/Date:0910061364 09.12.2014 Defer Date: Decision : The Committee decided to ratify norms for the export product Atazanavir Sulphate based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/247/2015- PI(Norms) dated 05.10..2015 , uploaded along with these minutes or as applied by the firm per decision of NC.

147

Case No.:279/13/82-

ALC4/2014
Party Name:HONOUR LAB LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/01282/AM15/ RLA File :09/24/040/00510/AM15/ Lic.No/Date:0910061362 09.12.2014 Defer Date:18.11.2015 Decision :Information called for from the firm is awaited, accordingly deferred the case.

148

Case No.:146/5/82-

ALC4/2015
Party Name:IPCA LABORATORIES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00286/AM16/ RLA File :03/94/040/00852/AM15/ Lic.No/Date:0310791848 09.12.2014 Defer Date:18.11.2015

149 Case No.:139/5/82- Party Name:J.B. Meet No/Date:10/82- Status:Case

ALC4/2015
CHEMICALS & PHARMACEUTICALS LIMITED ALC4/2015 15.10.2015 Deferred HQ File :01/82/050/00279/AM16/ RLA File :03/94/040/00872/AM15/ Lic.No/Date:0310791890 10.12.2014 Defer Date:18.11.2015 Decision : In light of comments of the representative of DoP, it was decided to call for copy of DML and master batch formula from the firm and deferred the case.

150

Case No.:153/5/82-

ALC4/2015
Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00293/AM16/ RLA File :34/24/040/00244/AM15/ Lic.No/Date:3410040785 12.12.2014 Defer Date:18.11.2015

151

Case No.:260/5/82-

ALC4/2015
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00400/AM16/ RLA File :09/24/040/00488/AM15/ Lic.No/Date:0910061381 12.12.2014 Defer Date:18.11.2015

152

Case No.:206/5/82-

ALC4/2015
SCIENCES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00346/AM16/ RLA File :09/24/040/00511/AM15/ Lic.No/Date:0910061382 12.12.2014 Defer Date:18.11.2015

153

Case No.:246/5/82-

ALC4/2015
Party Name:RAKSHIT DRUGS PVT LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00386/AM16/
RLA File :09/24/040/00426/AM15/
Lic.No/Date:0910061387 15.12.2014 Defer Date: Decision : The Committee decided to ratify norms for the export product Diacerein based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/281/2015-PI(Norms) dated 07.10.2015, uploaded along with these minutes or as applied by the firm whichever is less

154

Case No.:145/5/82-

ALC4/2015
Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : It was decided to defer the case for want of comments of D/o C&PC(Petrocamicals)

155

Case No.:130/5/82-

ALC4/2015
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred

HQ File :01/82/050/00270/AM16/ RLA File :03/95/040/00652/AM15/ Lic.No/Date:0310792103 17.12.2014 Defer Date:18.11.2015

156

Case No.:104/18/82-

ALC4/2014
Party Name:SHREE GANESH REMEDIES PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/01470/AM15/ RLA File :34/24/040/00245/AM15/ Lic.No/Date:3410040803 17.12.2014 Defer Date:18.11.2015

157

Case No.:127/5/82-

ALC4/2015
Party Name:EMAMI LIMITED, Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00267/AM16/ RLA File :02/24/040/00183/AM15/ Lic.No/Date:0210205355 18.12.2014 Defer Date:18.11.2015

158

Case No.:133/5/82-

ALC4/2015
Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

159

Case No.:99/5/82-

ALC4/2015
Party Name:FDC LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00239/AM16/
RLA File :03/94/040/00674/AM15/
Lic.No/Date:0310792173 19.12.2014 Defer Date: Decision :This case has already been approved in NC 08/AM16

160

Case No.:143/5/82-

ALC4/2015
Party Name:FDC LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00283/AM16/ RLA File :03/94/040/00834/AM15/ Lic.No/Date:0310792175 19.12.2014 Defer Date:18.11.2015

161

Case No.:97/5/82-

ALC4/2015
Party Name:INDOFIL INDUSTRIES LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00237/AM16/
RLA File :03/94/040/00896/AM15/
Lic.No/Date:0310792172 19.12.2014 Defer Date: Decision : The Committee decided to ratify norms for the export product Cymoxanil technical based on the recommendation of D/o C&PC, forwarded vide U.O. No.15022/17/2012-Ch-II dated 5.10.2015 , 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.

162

Case No.:205/5/82-

ALC4/2015
Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00345/AM16/ RLA File :09/24/040/00517/AM15/ Lic.No/Date:0910061414 19.12.2014 Defer Date:18.11.2015

163

Case No.:123/5/82-

ALC4/2015
Party Name:CADILA HEALTHCARE LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00263/AM16/ RLA File :08/24/040/00347/AM15/ Lic.No/Date:0810134112 22.12.2014 Defer Date:18.11.2015

164

Case No.:144/5/82-

ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00284/AM16/ RLA File :03/94/040/00892/AM15/ Lic.No/Date:0310792262 22.12.2014 Defer Date:18.11.2015

165

Case No.:224/5/82-

ALC4/2015
SCIENCES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. 35011/412/2015-PI(Norms) dt. October 2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

166

Case No.:262/5/82-

ALC4/2015
Party Name:VARAHI PHARMA PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00402/AM16/
RLA File :09/24/040/00481/AM15/
Lic.No/Date:0910061416 22.12.2014 Defer Date: Decision : The Committee decided to ratify norms for the export product Clopidogrel Bisulfate based on the recommendation of

D/o Pharmaceuticals forwarded vide O.M. No.35011/280/2015-PI(Norms) dated October 2015, uploaded along with these minutes or as

167

Case No.:216/5/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00356/AM16/
RLA File :09/24/040/00538/AM15/
Lic.No/Date:0910061424 22.12.2014 Defer Date:

Decision : The Committee decided to ratify norms for the export product Reversacol Saddle brown based on the recommendation of D/o C&PC forwarded vide U.O. No. 14010/138/2011-Ch- II dated 14.09.2015, uploaded along with these minutes or as applied by the firm whichever is NC.

168

Case No.:136/5/82-

ALC4/2015
Party Name:AVIGNON EXIM PVT.LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision :It was decided to defer the case for want of comments of D/o C&PC(Chemicals)

169

Case No.:96/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision :It was decided to call for copy DML and master batch formula from the firm and deferred the case.

170

Case No.:221/5/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

171

Case No.:329/5/82-

ALC4/2015
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00469/AM16/ RLA File :03/94/040/00899/AM15/ Lic.No/Date:0310792365 24.12.2014 Defer Date:18.11.2015

172

Case No.:114/5/82-

ALC4/2015
Party Name:NATIONAL TUBE INDUSTRIES, Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : It was decided to defer the case for want of comments of DC&PC(Petrochemicals).

173

Case No.:113/5/82-

ALC4/2015
Party Name:VEXTA LABORATORIES PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00253/AM16/ RLA File :03/95/040/00792/AM15/ Lic.No/Date:0310792352 24.12.2014 Defer Date:18.11.2015

174

Case No.:108/5/82-

ALC4/2015
Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00248/AM16/ RLA File :03/94/040/00908/AM15/ Lic.No/Date:0310792384 26.12.2014 Defer Date:15.10.2015 Decision : The Committee decided to ratify norms for the export product EDTA Diammonium based on the recommendation of D/o C&PC, forwarded vide U.O. No.14010/67/2011-Ch-II dated 30.09.2015 , uploaded along with these minutes or as applied by the firm whichever is less

175

Case No.:115/5/82-

ALC4/2015
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00255/AM16/ RLA File :03/95/040/00816/AM15/ Lic.No/Date:0310792387 26.12.2014 Defer Date:18.11.2015 Decision : The Committee decided to ratify norms for the export product Yantq 2020 based on the recommendation of DC&PCs forwarded vide U.O.No.14010/95/2011-Ch-II dated 11.09.2015 , 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.

176

Case No.:271/5/82-

ALC4/2015
Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00411/AM16/ RLA File :03/94/040/00882/AM15/ Lic.No/Date:0310792412 29.12.2014 Defer Date:18.11.2015

177

Case No.:241/5/82-

ALC4/2015
Party Name:ASTRIX LABORATORIES LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00381/AM16/ RLA File :09/24/040/00516/AM15/ Lic.No/Date:0910061461 29.12.2014 Defer Date:18.11.2015

178

Case No.:90/5/82-

ALC4/2015
Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00230/AM16/ RLA File :34/24/040/00254/AM15/ Lic.No/Date:3410040841 29.12.2014 Defer Date:18.11.2015

179

Case No.:218/5/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : It was decided to defer the case for want of comments of DoP

180 Case No.:65/5/82- ALC4/2015
Party Name:CLEAN SCIENCE AND Meet No/Date:10/82- ALC4/2015 Status:Case Deferred

TECHNOLOGY PVT.LTD. 15.10.2015 HQ File :01/82/050/00205/AM16/ RLA File :31/83/040/00204/AM15/ Lic.No/Date:3110065167 31.12.2014 Defer Date:18.11.2015

181

Case No.:222/5/82-

ALC4/2015
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00362/AM16/
RLA File :09/24/040/00553/AM15/
Lic.No/Date:0910061469 31.12.2014 Defer Date: Decision : The Committee decided to ratify norms for the export product (2R,3S) based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No. 35011/253/2015-PI(Norms) dated 08.10.2015, uploaded along with these minutes or as applied by the firm whichever is less

182

Case No.:134/5/82-

ALC4/2015
Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00274/AM16/ RLA File :03/94/040/00712/AM15/ Lic.No/Date:0310792545 01.01.2015 Defer Date:18.11.2015 Decision : : It was decided to defer the case for want of comments of DoP.

183

Case No.:226/5/82-

ALC4/2015
Party Name:EYTAN LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00366/AM16/ RLA File :09/24/040/00554/AM15/ Lic.No/Date:0910061471 01.01.2015 Defer Date:18.11.2015 Decision : : It was decided to defer the case for want of comments of DC&PC.

184

Case No.:137/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00277/AM16/ RLA File :03/94/040/00931/AM15/ Lic.No/Date:0310792547 01.01.2015 Defer Date:18.11.2015 Decision :It was decided to call for copy of DML and master bacth fourmula from the firm and deferred the case.

185

Case No.:138/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision: It was decided to call for copy of DML and master bacth fourmula from the firm and deferred the case.

186

Case No.:69/5/82-

ALC4/2015
Party Name:LUPIN LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00209/AM16/ RLA File :03/95/040/00807/AM15/ Lic.No/Date:0310792533 01.01.2015 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of comment from DoP.

187

Case No.:70/5/82-

ALC4/2015
Party Name:LUPIN LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00210/AM16/ RLA File :03/95/040/00606/AM15/ Lic.No/Date:0310792532 01.01.2015 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of comment from DoP.

188

Case No.:84/5/82-

ALC4/2015
Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00224/AM16/
RLA File :34/24/040/00259/AM15/
Lic.No/Date:3410040852 01.01.2015 Defer Date: recommendation of D/o C&PC, forwarded vide U.O.No.14010/164/2011-Ch-II dated 5.10.2015 ,

189

Case No.:105/5/82-

ALC4/2015
Party Name:CROWN CHEMICALS PVT.LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00245/AM16/ RLA File :03/94/040/00864/AM15/ Lic.No/Date:0310792569 02.01.2015 Defer Date:18.11.2015 Decision : : It was decided to defer the case for want of comment from D/o C&PC(Chemicals)

190

Case No.:106/5/82-

ALC4/2015
Party Name:CROWN CHEMICALS PVT.LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00246/AM16/ RLA File :03/94/040/00863/AM15/ Lic.No/Date:0310792568 02.01.2015 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of comment from D/o C&PC(Chemicals)

191

Case No.:68/5/82-

ALC4/2015
Party Name:POLYDRUG LABORATORIES PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00208/AM16/
RLA File :03/95/040/00810/AM15/
Lic.No/Date:0310792570 02.01.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No. 35011/415/2015-PI(Norms) dated 1.10.2015, uploaded along with these minutes or as applied by the firm whichever is less

192

Case No.:45/5/82-

ALC4/2015
SCIENCES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

193

Case No.:102/5/82-

ALC4/2015
Party Name:ALTA LABORATORIES LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

194

Case No.:107/5/82-

ALC4/2015
Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00247/AM16/ RLA File :03/94/040/00933/AM15/ Lic.No/Date:0310792634 07.01.2015 Date:15.10.2015 Decision : The Committee decided to ratify norms for the export product EDTA Diammonium based on the recommendation of D/o C&PC, forwarded vide U.O. No.14010/67/2011-Ch-II dated 30.09.2015 , uploaded along with these minutes or as applied by the firm whichever is less

195

Case No.:74/5/82-

ALC4/2015
Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 recommendation of D/o C&PCs forwarded vide U.O.No.14010/13/2012-Ch-II dated 5.10.2015 ,

196

Case No.:149/5/82-

ALC4/2015
Party Name:ALCHEMIE LABORATORIES Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

197

Case No.:62/5/82-

ALC4/2015
Party Name:INDO AMINES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00202/AM16/ RLA File :03/94/040/00928/AM15/ Lic.No/Date:0310792678 08.01.2015 Defer Date:18.11.2015 Decision : Information called for firm in the meeting no. 5/82 AM16 (minutes uploaded) is awaited. The case was deferred.

198 Case No.:63/5/82- ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:10/82- ALC4/2015 Status:Case Deferred

15.10.2015 HQ File :01/82/050/00203/AM16/ RLA File :03/94/040/00936/AM15/ Lic.No/Date:0310792676 08.01.2015 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of comment from DoP.

199

Case No.:122/5/82-

ALC4/2015
Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 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: Decision : The Committee decided to ratify norms for the export product NTA Trisodium based on the recommendation of D/o C&PC, forwarded vide U.O.No.14010/13/2012-Ch-II dated 5.10.2015 , 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.

200

Case No.:121/5/82-

ALC4/2015
Party Name:UNIJULES LIFE SCIENCES LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : It was decided to defer the case for want of comment from D/o C&PC(Chemicals)

201

Case No.:220/5/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00360/AM16/
RLA File :09/24/040/00560/AM15/
Lic.No/Date:0910061516 09.01.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Benzoyl cyano based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/276/2015- PI(Norms) dated 01.09.2015 , uploaded along with these minutes or as applied by the firm per decision of NC.

202

Case No.:219/5/82-

ALC4/2015
Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : It was decided to defer the case for want of comment from DC&PC

203

Case No.:80/5/82-

ALC4/2015
Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00220/AM16/
RLA File :05/23/040/00465/AM15/
Lic.No/Date:0510392782 09.01.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Cefixime based on the

recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/426/2015-PI(Norms) dated October 2015 , uploaded along with these minutes or as applied by the firm whichever is NC.

204

Case No.:239/5/82-

ALC4/2015
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : It was decided to defer the case for want of comment from DoP.

205

Case No.:150/5/82-

ALC4/2015
Party Name:ALKYL AMINES CHEMICALS LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00290/AM16/ RLA File :03/94/040/00866/AM15/ Lic.No/Date:0310792839 12.01.2015 Defer Date:18.11.2015

206

Case No.:141/5/82-

ALC4/2015
Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

207

Case No.:151/5/82-

ALC4/2015
Party Name:AGIO PHARMACEUTICALS LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00291/AM16/ RLA File :03/94/040/00902/AM15/ Lic.No/Date:0310792875 13.01.2015 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of comment from DoP

208

Case No.:119/5/82-

ALC4/2015
Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : It was decided to defer the case for want of comment from DoP

209

Case No.:92/5/82-

ALC4/2015
Party Name:ALKALOIDS CORPORATION Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00232/AM16/ RLA File :02/24/040/00203/AM15/ Lic.No/Date:0210205448 14.01.2015 Defer Date:18.11.2015

210 Case No.:59/5/82- ALC4/2015
Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:10/82- ALC4/2015 Status:Case Deferred

15.10.2015 HQ File :01/82/050/00199/AM16/ RLA File :03/94/040/00793/AM15/ Lic.No/Date:0310792911 14.01.2015 Defer Date:18.11.2015

211

Case No.:64/5/82-

ALC4/2015
Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00204/AM16/ RLA File :31/83/040/00200/AM15/ Lic.No/Date:3110065202 14.01.2015 Defer Date:18.11.2015 Decision : Information called for from the firm is awaited. The Committee accordingly decided to defer the case.

212

Case No.:66/5/82-

ALC4/2015
Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00206/AM16/ RLA File :31/83/040/00219/AM15/ Lic.No/Date:3110065206 14.01.2015 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of comment from DoP

213

Case No.:243/5/82-

ALC4/2015
SCIENCES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. 35011/412/2015-PI(Norms) dt.8.10.2015, uploaded along with these minutes decided to call for information from the firm and deferred the case.

214

Case No.:60/5/82-

ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00200/AM16/
RLA File :03/94/040/00963/AM15/
Lic.No/Date:0310793006 16.01.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/116/2015-PI(Norms) dated Sept. 2015 , uploaded along with these minutes or as applied by the firm whichever is less

215

Case No.:78/5/82-

ALC4/2015
Party Name:LAXMI ORGANIC INDUSTRIES LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00218/AM16/
RLA File :03/95/040/00814/AM15/
Lic.No/Date:0310793011 16.01.2015 Defer Date: recommendation of DC&PCs forwarded vide U.O.No.14010/49/2015-Ch-II dated 14.10.2015 ,

216

Case No.:72/5/82-

ALC4/2015
Party Name:MICRO INKS PRIVATE LIMITED. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00212/AM16/ RLA File :03/95/040/00658/AM15/ Lic.No/Date:0310793017 16.01.2015 Defer Date:18.11.2015

217

Case No.:111/5/82-

ALC4/2015
Party Name:MICRO INKS PRIVATE LIMITED. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00251/AM16/ RLA File :03/95/040/00648/AM15/ Lic.No/Date:0310792988 16.01.2015 Defer Date:18.11.2015

218

Case No.:89/5/82-

ALC4/2015
Party Name:CADILA HEALTHCARE LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00229/AM16/ RLA File :08/24/040/00253/AM15/ Lic.No/Date:0810134341 19.01.2015 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of comment from DoP

219

Case No.:242/5/82-

ALC4/2015
Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00382/AM16/
RLA File :09/24/040/00577/AM15/
Lic.No/Date:0910061545 19.01.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No. 35011/175/2015-PI(Norms) dated 05.10.2015, uploaded along with these minutes or as applied by the firm whichever is less

220

Case No.:249/5/82-

ALC4/2015
Party Name:PERKIN LABORATORIES Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00389/AM16/
RLA File :09/24/040/00588/AM15/
Lic.No/Date:0910061539 19.01.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/221/2015-PI (Norms) dated October 2015 , uploaded along with these minutes or as applied by the firm whichever is NC.

221

Case No.:79/5/82-

ALC4/2015
Party Name:UNIJULES LIFE SCIENCES LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00219/AM16/ RLA File :03/95/040/00877/AM15/ Lic.No/Date:0310793058 19.01.2015 Defer Date:18.11.2015 Decision :It was decided to defer the case for want of comments of DoP.

222

Case No.:110/5/82-

ALC4/2015
Party Name:UNIMAX CHEMICALS PVT LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Rejected HQ File :01/82/050/00250/AM16/
RLA File :03/95/040/00811/AM15/
Lic.No/Date:0310793038 19.01.2015 Defer Date: Decision : In view of the facts brough to the notice by DoP, the case was rejected, copy of DoP O.M. No. 35011/315/2014-PI (norms) dated 30.09.2015 uploaded alongwith these minutes.

223

Case No.:52/5/82-

ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00192/AM16/ RLA File :03/94/040/00953/AM15/ Lic.No/Date:0310793104 20.01.2015 Defer Date:18.11.2015

224

Case No.:147/5/82-

ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00287/AM16/ RLA File :03/94/040/00964/AM15/ Lic.No/Date:0310793105 20.01.2015 Defer Date:18.11.2015

225

Case No.:55/5/82-

ALC4/2015
Party Name:IPCA LABORATORIES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00195/AM16/ RLA File :03/94/040/00975/AM15/ Lic.No/Date:0310793123 20.01.2015 Defer Date:18.11.2015

226

Case No.:88/5/82-

ALC4/2015
Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

227

Case No.:132/5/82-

ALC4/2015
Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00272/AM16/
RLA File :03/94/040/00947/AM15/
Lic.No/Date:0310793170 21.01.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No35011/175(i)/2015-PI(Norms) dated October 2015 , uploaded along with these minutes or as applied by the firm whichever is NC.

228

Case No.:56/5/82-

ALC4/2015
Party Name:IPCA Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00196/AM16/
RLA File :03/94/040/00973/AM15/
Lic.No/Date:0310793182 21.01.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No. 35011/244/2015-PI(Norms) dated 29th Sept. 2015 , uploaded along with these minutes or as applied by the firm whichever is NC.

229

Case No.:131/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00271/AM16/ RLA File :03/94/040/00988/AM15/ Lic.No/Date:0310793181 21.01.2015 Defer Date:18.11.2015

230

Case No.:87/5/82-

ALC4/2015
Party Name:SHREE BANKEY BEHARI LAL BOARD MILLS Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00227/AM16/ RLA File :05/24/040/00454/AM15/ Lic.No/Date:0510392955 21.01.2015 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of comments of DC&PC

231

Case No.:86/5/82-

ALC4/2015
Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00226/AM16/ RLA File :05/24/040/00489/AM15/ Lic.No/Date:0510392966 22.01.2015 Defer Date:18.11.2015

232

Case No.:165/5/82-

ALC4/2015
Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00305/AM16/
RLA File :22/24/040/00091/AM15/
Lic.No/Date:2210015173 23.01.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No. 35011/407/2015-PI(Norms) dated 01.10.2015, uploaded along with these minutes or as applied by the firm whichever is less

233

Case No.:71/5/82-

ALC4/2015
Party Name:MELOG SPECIALITY CHEMICALS PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00211/AM16/ RLA File :03/95/040/00868/AM15/ Lic.No/Date:0310793254 23.01.2015 Defer Date:18.11.2015 Decision : The Committee based on the written comments forwarded by the D/o C&PC, vide letter No.14010/22/2012-Ch-II dt. 7th October 2015, uploaded along with these minutes decided

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

234

Case No.:76/5/82-

ALC4/2015
Party Name:MELOG SPECIALITY CHEMICALS PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00216/AM16/ RLA File :03/95/040/00891/AM15/ Lic.No/Date:0310793255 23.01.2015 Defer Date:18.11.2015 Decision : The Committee based on the written comments forwarded by the D/o C&PC, vide letter No.14010/22/2012-Ch-II dt. 7th October 2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

235

Case No.:77/5/82-

ALC4/2015
Party Name:THINQ PHARMA-CRO LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00217/AM16/
RLA File :03/95/040/00857/AM15/
Lic.No/Date:0310793256 23.01.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Ractopamine Hcl based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/105/2015- PI(Norms) dated 07.10.2015 , uploaded along with these minutes or as applied by the firm per decision of NC.

236

Case No.:204/5/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00344/AM16/ RLA File :09/24/040/00596/AM15/ Lic.No/Date:0910061555 23.01.2015 Defer Date:18.11.2015 Decision :It was decided to defer the case for want of Comments from D/o C&PC.

237

Case No.:229/5/82-

ALC4/2015
Party Name:ATUL LIMITED, Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00369/AM16/ RLA File :08/24/040/00391/AM15/ Lic.No/Date:0810134402 27.01.2015 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of Comments from D/o C&PC(Petrochemicals)

238

Case No.:269/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : It was decided to call for copy DML and master batch formula from the firm and deferred the case.

239

Case No.:85/5/82-

ALC4/2015
Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File RLA File Lic.No/Date:0510392989 Defer

:01/82/050/00225/AM16/ :05/24/040/00500/AM15/ 27.01.2015 Date:18.11.2015 Decision : It was decided to defer the case for want of Comments from D/o C&PC(Chemicals)

240

Case No.:58/5/82-

ALC4/2015
Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00198/AM16/ RLA File :03/94/040/00980/AM15/ Lic.No/Date:0310793360 28.01.2015 Defer Date:18.11.2015

241

Case No.:230/5/82-

ALC4/2015
Party Name:R.K.INDUSTRIES, Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00370/AM16/
RLA File :08/24/040/00394/AM15/
Lic.No/Date:0810134414 28.01.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product based on the recommendation of D/o C&PC, forwarded vide U.O. No.14010/71/2013-Ch-II dated 06.10.2015 , 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.

242

Case No.:168/5/82-

ALC4/2015
Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00308/AM16/
RLA File :34/24/040/00277/AM15/
Lic.No/Date:3410040906 29.01.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/73/2015-PI(Norms) dated Sept. 2015 , uploaded along with these minutes or as applied by the firm whichever is less

243

Case No.:163/5/82-

ALC4/2015
Party Name:RANBAXY LABORATORIES LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : It was decided to defer the case for want of Comments from DoP.

244

Case No.:166/5/82-

ALC4/2015
Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00306/AM16/ RLA File :08/24/040/00386/AM15/ Lic.No/Date:0810134454 30.01.2015 Defer Date:18.11.2015

245

Case No.:274/5/82-

ALC4/2015
Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00414/AM16/
RLA File :03/94/040/01017/AM15/
Lic.No/Date:0310793439 30.01.2015 Defer Date:

recommendation of D/o C&PC forwarded vide U.O. No.14010/96/2011-Ch-II dated 8.10.2015 ,

246

Case No.:138/8/82-

ALC4/2015
Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

247

Case No.:209/5/82-

ALC4/2015
Party Name:TRIMAX BIO SCIENCES PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00349/AM16/ RLA File :09/24/040/00442/AM15/ Lic.No/Date:0910061573 02.02.2015 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of Comments from DC&PC

248

Case No.:208/5/82-

ALC4/2015
Party Name:ASTRIX LABORATORIES LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00348/AM16/ RLA File :09/24/040/00534/AM15/ Lic.No/Date:0910061583 03.02.2015 Defer Date:18.11.2015

249

Case No.:275/5/82-

ALC4/2015
Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

250

Case No.:158/5/82-

ALC4/2015
Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00298/AM16/ RLA File :30/24/040/00051/AM15/ Lic.No/Date:3010103361 03.02.2015 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of Comments from DC&PC(Petrochemicals).

251

Case No.:233/5/82-

ALC4/2015
Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00373/AM16/
RLA File :05/24/040/00525/AM15/
Lic.No/Date:0510393079 04.02.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Atorvastatin Calcium based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/141/2015- PI(Norms) dated October 2015 , uploaded along with these minutes or as applied by the firm per decision of NC.

252

Case No.:234/5/82-

ALC4/2015
Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00374/AM16/ RLA File :05/24/040/00526/AM15/ Lic.No/Date:0510393080 04.02.2015 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of Comments from DoP

253

Case No.:164/5/82-

ALC4/2015
Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00304/AM16/ RLA File :05/24/040/00513/AM15/ Lic.No/Date:0510393078 04.02.2015 Defer Date:18.11.2015

254

Case No.:157/5/82-

ALC4/2015
Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00297/AM16/ RLA File :22/24/040/00100/AM15/ Lic.No/Date:2210015187 05.02.2015 Defer Date:18.11.2015

255

Case No.:284/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision :It was decided to call for copy of DML and master batch formula from the firm and deferred the case.

256

Case No.:238/5/82-

ALC4/2015
Party Name:KLJ PLASTICIZERS LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00378/AM16/ RLA File :05/23/040/00504/AM15/ Lic.No/Date:0510393099 05.02.2015 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of Comments from DC&PC(Petrochemicals)

257

Case No.:169/5/82-

ALC4/2015
Party Name:TIDE INDUSTRIES Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

258

Case No.:268/5/82-

ALC4/2015
Party Name:CATAPHARMA CHEMICALS PVT. LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00408/AM16/ RLA File :31/83/040/00209/AM15/ Lic.No/Date:3110065261 06.02.2015 Defer Date:18.11.2015

259

Case No.:227/5/82-

ALC4/2015
Party Name:MICRO LABS LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00367/AM16/ RLA File :07/24/040/00378/AM15/ Lic.No/Date:0710107574 09.02.2015 Defer Date:18.11.2015

260

Case No.:342/5/82-

ALC4/2015
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00482/AM16/ RLA File :03/95/040/00585/AM15/ Lic.No/Date:0310793707 09.02.2015 Defer Date:18.11.2015

261

Case No.:344/5/82-

ALC4/2015
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00484/AM16/ RLA File :03/95/040/00445/AM15/ Lic.No/Date:0310793706 09.02.2015 Defer Date:18.11.2015

262

Case No.:161/5/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00301/AM16/ RLA File :05/24/040/00472/AM15/ Lic.No/Date:0510393118 09.02.2015 Defer Date:18.11.2015 recommendation of D/o C&PC forwarded vide U.O.No.14010/18/2014-Ch-II dated 02.09.2015 ,

263

Case No.:346/5/82-

ALC4/2015
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00486/AM16/
RLA File :03/95/040/00947/AM15/
Lic.No/Date:0310793722 09.02.2015 Defer Date: recommendation of D/o C&PC forwarded vide U.O.No.14010/95/2011-Ch-II dated 11.09.2015 ,

264

Case No.:319/5/82-

ALC4/2015
Party Name:EXEMED PHARMACEUTICALS Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00459/AM16/ RLA File :34/24/040/00297/AM15/ Lic.No/Date:3410040950 10.02.2015 Defer Date:18.11.2015

265

Case No.:190/5/82-

ALC4/2015
Party Name:HONOUR LAB LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00330/AM16/
RLA File :09/24/040/00629/AM15/
Lic.No/Date:0910061597 10.02.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/245/2015-PI(Norms) dated Sept. 2015 , uploaded along with these minutes or as applied by the firm whichever is less

266

Case No.:290/5/82-

ALC4/2015
Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

267

Case No.:13/18/82-

ALC4/2014
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/01379/AM15/
RLA File :09/24/040/00605/AM15/
Lic.No/Date:0910061603 10.02.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/292/2015-PI(Norms) dated 07.10.2015 , uploaded along with these minutes or as applied by the firm whichever is less

268

Case No.:231/5/82-

ALC4/2015
Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00371/AM16/ RLA File :08/24/040/00403/AM15/ Lic.No/Date:0810134561 10.02.2015 Defer Date:18.11.2015

269

Case No.:167/5/82-

ALC4/2015
Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00307/AM16/ RLA File :05/23/040/00435/AM15/ Lic.No/Date:0510393162 11.02.2015 Defer Date:18.11.2015

270 Case No.:171/5/82- Party Name:FRESENIUS Meet No/Date:10/82- Status:Case

ALC4/2015
KABI ONCOLOGY LIMITED ALC4/2015 15.10.2015 Deferred HQ File :01/82/050/00311/AM16/ RLA File :05/23/040/00434/AM15/ Lic.No/Date:0510393163 11.02.2015 Defer Date:18.11.2015

271

Case No.:286/5/82-

ALC4/2015
Party Name:GALAXY SURFACTANTS LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00426/AM16/
RLA File :03/94/040/01054/AM15/
Lic.No/Date:0310793796 11.02.2015 Defer Date: recommendation of D/o C&PC, forwarded vide U.O.No.14010/148/2011-CH-II dated 30.09.2015 , 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.

272

Case No.:348/5/82-

ALC4/2015
Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00488/AM16/
RLA File :03/95/040/00895/AM15/
Lic.No/Date:0310793791 11.02.2015 Defer Date: recommendation of D/o C&PC, forwarded vide U.O.No.14010/13/2012-CH-II dated 05.10.2015 ,

273

Case No.:159/5/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00299/AM16/
RLA File :05/24/040/00484/AM15/
Lic.No/Date:0510393136 11.02.2015 Defer Date: recommendation of D/o C&PC forwarded vide U.O.No.14010/18/2014-Ch-II dated 02.09.2015,

274

Case No.:160/5/82-

ALC4/2015
Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00300/AM16/ RLA File :05/24/040/00389/AM15/ Lic.No/Date:0510393132 11.02.2015 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of Comments from DC&PC(Petrochemicals)

275

Case No.:127/8/82-

ALC4/2015
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00923/AM16/ RLA File :03/94/040/01056/AM15/ Lic.No/Date:0310793858 12.02.2015 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of Comments from DC&PC(Chemicals)

276

Case No.:333/5/82-

ALC4/2015
Party Name:MEHTA API PVT LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

277

Case No.:345/5/82-

ALC4/2015
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00485/AM16/ RLA File :03/95/040/00909/AM15/ Lic.No/Date:0310793856 12.02.2015 Defer Date:18.11.2015

278

Case No.:347/5/82-

ALC4/2015
Party Name:ROYAL PHARMA Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00487/AM16/ RLA File :03/95/040/00958/AM15/ Lic.No/Date:0310793866 12.02.2015 Defer Date:18.11.2015

279

Case No.:201/5/82-

ALC4/2015
Party Name:AKZO NOBEL INDIA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00341/AM16/ RLA File :02/24/040/00178/AM15/ Lic.No/Date:0210205557 13.02.2015 Defer Date:18.11.2015

280

Case No.:330/5/82-

ALC4/2015
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00470/AM16/ RLA File :03/95/040/00901/AM15/ Lic.No/Date:0310793891 16.02.2015 Defer Date:18.11.2015

281

Case No.:42/5/82-

ALC4/2015
SCIENCES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00182/AM16/
RLA File :09/24/040/00633/AM15/
Lic.No/Date:0910061619 16.02.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/278/2015-PI(Norms) dated 05.10.2015 , uploaded along with these minutes or as applied by the firm whichever is less

282

Case No.:235/5/82-

ALC4/2015
Party Name:AMANTA HEALTHCARE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred

HQ File :01/82/050/00375/AM16/ RLA File :08/24/040/00413/AM15/ Lic.No/Date:0810134610 18.02.2015 Defer Date:18.11.2015

283

Case No.:281/5/82-

ALC4/2015
Party Name:IPCA Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00421/AM16/
RLA File :03/94/040/01069/AM15/
Lic.No/Date:0310793943 18.02.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No. 35011/106/2015-PI(Norms) dated August, 2015, uploaded along with these minutes or as applied by the firm whichever is NC.

284

Case No.:283/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

285

Case No.:285/5/82-

ALC4/2015
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00425/AM16/ RLA File :03/94/040/01092/AM15/ Lic.No/Date:0310793985 19.02.2015 Defer Date:18.11.2015 Decision : It was decided to call for copy DML and master batch formula from the firm and deferred the case.

286

Case No.:279/5/82-

ALC4/2015
Party Name:CROWN CHEMICALS PVT.LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

287

Case No.:288/5/82-

ALC4/2015
Party Name:CROWN CHEMICALS PVT.LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

288

Case No.:237/5/82-

ALC4/2015
Party Name:INTAS PHARMACEUTICALS LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File RLA File Lic.No/Date:0810134636 Defer

:01/82/050/00377/AM16/ :08/24/040/00423/AM15/ 19.02.2015 Date:18.11.2015

289

Case No.:332/5/82-

ALC4/2015
Party Name:O C SPECIALITIES PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

290

Case No.:317/5/82-

ALC4/2015
Party Name:AMI LIFESCIENCES P LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00457/AM16/
RLA File :34/24/040/00305/AM15/
Lic.No/Date:3410040974 20.02.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No. 35011/431/2015-PI(Norms) dated October 2015, uploaded along with these minutes or as applied by the firm whichever is NC.

291

Case No.:38/5/82-

ALC4/2015
Party Name:MYLAN Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00178/AM16/
RLA File :09/24/040/00591/AM15/
Lic.No/Date:0910061638 20.02.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/279/2015-PU(Norms) dated 05.10.2015 , uploaded along with these minutes or as applied by the firm whichever is less

292

Case No.:335/5/82-

ALC4/2015
Party Name:PRIVI ORGANICS LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

293

Case No.:31/5/82-

ALC4/2015
Party Name:SRIAM LABS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00171/AM16/
RLA File :09/24/040/00630/AM15/
Lic.No/Date:0910061641 23.02.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No. 35011/277/2015-PI-(Norms) dated 05.10.2015, uploaded along with these minutes or as applied by the firm whichever is less

294

Case No.:318/5/82-

ALC4/2015
Party Name:TIDE INDUSTRIES Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00458/AM16/ RLA File :34/24/040/00310/AM15/ Lic.No/Date:3410040978 23.02.2015 Defer Date:18.11.2015

295

Case No.:280/5/82-

ALC4/2015
Party Name:FERMENTA BIOTECH LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

296

Case No.:293/5/82-

ALC4/2015
Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00433/AM16/ RLA File :08/24/040/00426/AM15/ Lic.No/Date:0810134657 24.02.2015 Defer Date:18.11.2015 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. 35011/260/2015-PI(Norms) dt. Sept. 2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

297

Case No.:232/5/82-

ALC4/2015
Party Name:RANBAXY LABORATORIES LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

298

Case No.:334/5/82-

ALC4/2015
Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

299

Case No.:277/5/82-

ALC4/2015
Party Name:INDO AMINES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00417/AM16/ RLA File :03/94/040/01024/AM15/ Lic.No/Date:0310794134 25.02.2015 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of Comments from DC&PC

300

Case No.:308/5/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved

HQ File :01/82/050/00448/AM16/
RLA File :05/24/040/00511/AM15/
Lic.No/Date:0510393355 25.02.2015 Defer Date: recommendation of D/o C&PC forwarded vide U.O.No.14010/18/2014-Ch-II dated 02.09.2015 ,

301

Case No.:309/5/82-

ALC4/2015
Party Name:SHREE VALLABH CHEMICAL Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

302

Case No.:259/5/82-

ALC4/2015
Party Name:VIRDEV INTERMEDIATES PVT LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00399/AM16/ RLA File :52/24/040/00067/AM15/ Lic.No/Date:5210041437 25.02.2015 Defer Date:18.11.2015 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. 35011/92/2015-PI(Norms) dt. Sept. 2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

303

Case No.:41/5/82-

ALC4/2015
Party Name:DR REDDYS LABORATORIES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00181/AM16/ RLA File :09/24/040/00657/AM15/ Lic.No/Date:0910061651 26.02.2015 Defer Date:18.11.2015

304

Case No.:314/5/82-

ALC4/2015
Party Name:R L FINE CHEM Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00454/AM16/ RLA File :07/24/040/00416/AM15/ Lic.No/Date:0710107713 26.02.2015 Defer Date:18.11.2015

305

Case No.:325/5/82-

ALC4/2015
Party Name:SWISS EXPORTS PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00465/AM16/ RLA File :08/24/040/00401/AM15/ Lic.No/Date:0810134676 26.02.2015 Defer Date:18.11.2015

306

Case No.:273/5/82-

ALC4/2015
Party Name:BHARAT SERUMS & VACCINES LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00413/AM16/ RLA File :03/94/040/01055/AM15/ Lic.No/Date:0310794262 27.02.2015 Defer Date:18.11.2015

Decision : It was decided to defer the case for want of Comments from DBT

307

Case No.:452/5/82-

ALC4/2015
Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

308

Case No.:297/5/82-

ALC4/2015
Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00437/AM16/
RLA File :05/23/040/00510/AM15/
Lic.No/Date:0510393404 27.02.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Kinox-24 based on the recommendation of D/o C&PC U.O.No.14010/7/2011-Ch-II dated 15.9.2015 , 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.

309

Case No.:298/5/82-

ALC4/2015
Party Name:MEDICEF PHARMA, Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00438/AM16/ RLA File :22/24/040/00095/AM15/ Lic.No/Date:2210015200 27.02.2015 Defer Date:18.11.2015

310

Case No.:414/5/82-

ALC4/2015
Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00554/AM16/ RLA File :03/94/040/01090/AM15/ Lic.No/Date:0310794291 02.03.2015 Defer Date:18.11.2015

311

Case No.:337/5/82-

ALC4/2015
Party Name:MANGALAM DRUGS & ORGANICS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00477/AM16/
RLA File :03/95/040/01001/AM15/
Lic.No/Date:0310794280 02.03.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Tenofovir Disoproxil fumarate based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/434/2015-PI (Norms) dated October.2015 , uploaded along with these minutes or as

312

Case No.:341/5/82-

ALC4/2015
Party Name:MANGALAM DRUGS & ORGANICS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00481/AM16/
RLA File :03/95/040/01002/AM15/
Lic.No/Date:0310794281 02.03.2015 Defer Date:

recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/103/2014-PI (Norms) dated Sept. 2014 , uploaded along with these minutes or as applied by the firm whichever is less

313

Case No.:316/5/82-

ALC4/2015
Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00456/AM16/ RLA File :34/24/040/00280/AM15/ Lic.No/Date:3410041005 03.03.2015 Defer Date:18.11.2015

314

Case No.:295/5/82-

ALC4/2015
Party Name:PROLIFE INDUSTRIES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : The Committee based on the written comments forwarded by the D/o C&PC, 14010/74/2014-CH-II dated 30.09.2015 uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

315

Case No.:294/5/82-

ALC4/2015
Party Name:ATUL INTERMEDIATES Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00434/AM16/ RLA File :08/24/040/00264/AM15/ Lic.No/Date:0810134727 04.03.2015 Defer Date:18.11.2015 Decision : : It was decided to defer the case for want of Comments from DC&PC(Petrochemicals)

316

Case No.:326/5/82-

ALC4/2015
Party Name:ATUL INTERMEDIATES Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00466/AM16/ RLA File :08/24/040/00429/AM15/ Lic.No/Date:0810134726 04.03.2015 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of Comments from DC&PC(Petrochemicals)

317

Case No.:415/5/82-

ALC4/2015
Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00555/AM16/ RLA File :03/94/040/01111/AM15/ Lic.No/Date:0310794368 04.03.2015 Defer Date:18.11.2015

318

Case No.:422/5/82-

ALC4/2015
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00562/AM16/ RLA File :03/94/040/01120/AM15/ Lic.No/Date:0310794347 04.03.2015 Defer Date:18.11.2015

319

Case No.:451/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : In light of comments of the representative of DoP, it was decided to call for copy of DML and master batch formula from the firm and deferred the case.

320

Case No.:324/5/82-

ALC4/2015
Party Name:SWISS PARENTERALS PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00464/AM16/ RLA File :08/24/040/00439/AM15/ Lic.No/Date:0810134729 04.03.2015 Defer Date:18.11.2015

321

Case No.:303/5/82-

ALC4/2015
Party Name:ASSOCIATED DYESTUFF PVT. LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

322

Case No.:39/5/82-

ALC4/2015
Party Name:GRANULES INDIA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00179/AM16/
RLA File :09/24/040/00650/AM15/
Lic.No/Date:0910061669 05.03.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/262/2015-PI(Norms) dated October, 2015 , uploaded along with these minutes or as applied by the firm whichever is NC.

323

Case No.:323/5/82-

ALC4/2015
Party Name:ADCOCK INGRAM LTD, Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00463/AM16/ RLA File :07/24/040/00444/AM15/ Lic.No/Date:0710107772 09.03.2015 Defer Date:18.11.2015

324

Case No.:299/5/82-

ALC4/2015
Party Name:G.G.CHEMICALS & PHARMACEUTICALS PVT.LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00439/AM16/
RLA File :22/24/040/00106/AM15/
Lic.No/Date:2210015206 09.03.2015 Defer Date: recommendation of D/o Pharmaceuticals provided vide O.M.no.35011/226/2015-PI (Norms)

dated 29.09.2015, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA may take further action accordingly

325

Case No.:423/5/82-

ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00563/AM16/
RLA File :03/94/040/01116/AM15/
Lic.No/Date:0310794418 09.03.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Dorzolamide Hcl based on the recommendation of D/o Pharmaceuticals provided vide O.M.no.35011/134/2012-PI (Norms) dated July, 2012 uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA may take further action accordingly

326

Case No.:445/5/82-

ALC4/2015
Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00585/AM16/
RLA File :03/94/040/01143/AM15/
Lic.No/Date:0310794485 10.03.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Niclosamide Anhydrous based on the recommendation of D/o Pharmaceuticals provided vide O.M.no.35011/410/2015-PI (Norms) dated 29.09.2015, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA may take further action accordingly

327

Case No.:13/5/82-

ALC4/2015
Party Name:MYLAN Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00153/AM16/
RLA File :09/24/040/00343/AM15/
Lic.No/Date:0910061674 10.03.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Valganciclovir Hcl based on the recommendation of D/o Pharmaceuticals provided vide O.M.no.35011/272/2015-PI (Norms) dated 07.10.2015, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA may take further action accordingly

328

Case No.:434/5/82-

ALC4/2015
Party Name:POLYDRUG LABORATORIES PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00574/AM16/ RLA File :03/95/040/01025/AM15/ Lic.No/Date:0310794472 10.03.2015 Defer Date:18.11.2015

329

Case No.:300/5/82-

ALC4/2015
Party Name:ADVANCE PETROCHEMICALS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : It was decided to defer the case for want of Comments from DC&PC(petrochemicals)

330

Case No.:450/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

331

Case No.:4/2/82-

ALC4/2015
Party Name:VIRUPAKSHA ORGANICS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00019/AM16/
RLA File :09/24/040/00674/AM15/
Lic.No/Date:0910061679 11.03.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Sofosbuvir based on the recommendation of D/o Pharmaceuticals provided vide O.M.no.35011/179/2015-PI (Norms) dated 14.09.2015, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA may take further action accordingly.

332

Case No.:9/4/82-

ALC4/2015
Party Name:VIRUPAKSHA ORGANICS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00048/AM16/
RLA File :09/24/040/00673/AM15/
Lic.No/Date:0910061680 11.03.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Sofosbuvir based on the recommendation of D/o Pharmaceuticals provided vide O.M.no.35011/179/2015-PI (Norms) dated 14.09.2015, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA may take further action accordingly.

333

Case No.:447/5/82-

ALC4/2015
Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

334

Case No.:412/5/82-

ALC4/2015
Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00552/AM16/ RLA File :03/94/040/00983/AM15/ Lic.No/Date:0310794539 12.03.2015 Defer Date:18.11.2015

335

Case No.:301/5/82-

ALC4/2015
Party Name:CADILA HEALTHCARE LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00441/AM16/ RLA File :08/24/040/00460/AM15/ Lic.No/Date:0810134780 12.03.2015 Defer Date:18.11.2015

336

Case No.:305/5/82-

ALC4/2015
Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00445/AM16/
RLA File :05/23/040/00555/AM15/
Lic.No/Date:0510393548 12.03.2015 Defer Date:

Decision : The Committee decided to ratify norms for the export product Ceftibuten based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/224/2015-PI(Norms) dated 29.09.2015 , uploaded along with these minutes or as applied by the firm whichever is NC.

337

Case No.:413/5/82-

ALC4/2015
Party Name:INDO AMINES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00553/AM16/ RLA File :03/94/040/01145/AM15/ Lic.No/Date:0310794545 12.03.2015 Defer Date:18.11.2015 Decision : : It was decided to defer the case for want of Comments from DC&PC(Chemicals)

338

Case No.:34/5/82-

ALC4/2015
Party Name:ASCENT FINECHEM PVT. LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00174/AM16/ RLA File :08/24/040/00397/AM15/ Lic.No/Date:0810134800 13.03.2015 Defer Date:18.11.2015

339

Case No.:425/5/82-

ALC4/2015
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00565/AM16/ RLA File :03/94/040/01126/AM15/ Lic.No/Date:0310794611 16.03.2015 Defer Date:18.11.2015

340

Case No.:33/5/82-

ALC4/2015
Party Name:CADILA HEALTHCARE LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00173/AM16/ RLA File :08/24/040/00466/AM15/ Lic.No/Date:0810134816 16.03.2015 Defer Date:18.11.2015

341

Case No.:421/5/82-

ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00561/AM16/
RLA File :03/94/040/01151/AM15/
Lic.No/Date:0310794615 16.03.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Chlordiazepoxide Capsules BP based on the recommendation D/o Pharmaceuticals forwarded vide O.M. No.35011/111/2015-PI(Norms) dated Sept. 2015 uploaded along with these minutes or as

342

Case No.:409/5/82-

ALC4/2015
Party Name:NOCIL LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

Decision : The Committee based on the written comments forwarded by the D/o C&PC, letter No.14010/32/2012-Ch-II dated 29.09.2015 uploaded along with these minutes decided to call for information from the firm and deferred the case.

343

Case No.:302/5/82-

ALC4/2015
Party Name:STERILE INDIA PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00442/AM16/ RLA File :05/24/040/00589/AM15/ Lic.No/Date:0510393585 16.03.2015 Defer Date:18.11.2015 Decision : The Committee based on the written comments forwarded by the DoP letter No.35011/416/2015-PI(Norms) dated 08.10.2015 uploaded along with these minutes decided to call for information from the firm and deferred the case.

344

Case No.:9/5/82-

ALC4/2015
SCIENCES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00149/AM16/
RLA File :09/24/040/00671/AM15/
Lic.No/Date:0910061707 16.03.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product methyl ( E ) based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/275/2015-PI(Norms) dated 07.10.2015 , uploaded along with these minutes or as applied by the firm whichever is less

345

Case No.:45/4/82-

ALC4/2015
Party Name:TIDE INDUSTRIES Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

346

Case No.:429/5/82-

ALC4/2015
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00569/AM16/ RLA File :03/95/040/01056/AM15/ Lic.No/Date:0310794585 16.03.2015 Defer Date:18.10.2015 recommendation of DC&PCs forwarded vide U.O.No.14010/95/2011-Ch-II dated 11.09.2015 ,

347

Case No.:6/8/82-

ALC4/2015
Party Name:YELURI FORMULATIONS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

348 Case No.:289/5/82- ALC4/2015
Party Name:HPL ADDITIVES Meet No/Date:10/82- ALC4/2015 Status:Case Deferred

LIMITED(FORMERLY KNOWN HIGH POLYMER 15.10.2015 HQ File :01/82/050/00429/AM16/ RLA File :05/23/040/00560/AM15/ Lic.No/Date:0510393593 17.03.2015 Defer Date:18.11.2015 Decision : The Committee decided to ratify norms for the export product p- Toluene based on the recommendation of D/o C&PC U.O.No.14010/7/2011-Ch-II dated 15.9.2015 , 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.

349

Case No.:44/5/82-

ALC4/2015
Party Name:SRIAM LABS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00184/AM16/
RLA File :09/24/040/00666/AM15/
Lic.No/Date:0910061718 17.03.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Telmisartan based on the recommendation of D/o Pharmaceuticals O.M.No.35011/270/2015-PI(Norms) dated 07.10.2015 , 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.

350

Case No.:291/5/82-

ALC4/2015
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

351

Case No.:426/5/82-

ALC4/2015
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00566/AM16/ RLA File :03/94/040/01162/AM15/ Lic.No/Date:0310794710 19.03.2015 Defer Date:18.11.2015

352

Case No.:420/5/82-

ALC4/2015
Party Name:KUSUMA PHARMA Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00560/AM16/ RLA File :03/94/040/01175/AM15/ Lic.No/Date:0310794718 19.03.2015 Defer Date:18.11.2015 recommendation of D/o C&PCs forwarded vide U.O.No.14010/31/2009-Ch-II dated 11.09.2015 ,

353

Case No.:192/5/82-

ALC4/2015
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00332/AM16/ RLA File :04/24/040/00009/AM15/ Lic.No/Date:0410160310 19.03.2015 Defer Date:18.11.2015

354

Case No.:311/5/82-

ALC4/2015
Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00451/AM16/
RLA File :05/24/040/00597/AM15/
Lic.No/Date:0510393646 19.03.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Atorvastatin Calcium based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/141/2015- PI(Norms) dated October 2015 , uploaded along with these minutes or as applied by the firm per decision of NC.

355

Case No.:407/5/82-

ALC4/2015
Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00547/AM16/ RLA File :03/95/040/00934/AM15/ Lic.No/Date:0310794735 20.03.2015 Defer Date:18.11.2015

356

Case No.:408/5/82-

ALC4/2015
Party Name:SHIRDI CHEMICALS PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00548/AM16/
RLA File :03/95/040/01059/AM15/
Lic.No/Date:0310794798 23.03.2015 Defer Date Decision : The Committee decided to ratify norms for the export product based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/105/2011-Ch-II dated30.09.2015 ,

357

Case No.:183/5/82-

ALC4/2015
Party Name:SPAK ORGOCHEM (INDIA) PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

358

Case No.:310/5/82-

ALC4/2015
Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00450/AM16/
RLA File :05/23/040/00562/AM15/
Lic.No/Date:0510393721 24.03.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Cefixime based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/426/2015-PI(Norms) dated October 2015 , uploaded along with these minutes or as applied by the firm whichever is NC.

359

Case No.:410/5/82-

ALC4/2015
Party Name:INDO AMINES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00550/AM16/ RLA File :03/94/040/01184/AM15/ Lic.No/Date:0310794835 24.03.2015 Defer Date:18.11.2015

360

Case No.:191/5/82-

ALC4/2015
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00331/AM16/ RLA File :04/24/040/00309/AM15/ Lic.No/Date:0410160331 24.03.2015 Defer Date:18.11.2015 Decision : The Committee in light of comment of DoP forwarded vide OM.No.35011/202/2015- PI(Norms) dated October 2015, uploaded along with these minutes, decided to call for information from the firm and deferred the case.

361

Case No.:193/5/82-

ALC4/2015
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00333/AM16/ RLA File :04/24/040/00310/AM15/ Lic.No/Date:0410160332 24.03.2015 Defer Date:18.11.2015 Decision: The Committee in light of comment of DoP forwarded vide OM.No.35011/202/2015- PI(Norms) dated October 2015, uploaded along with these minutes, decided to call for information from the firm and deferred the case.

362

Case No.:178/5/82-

ALC4/2015
Party Name:WINTAC LIMITED, Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00318/AM16/ RLA File :07/24/040/00437/AM15/ Lic.No/Date:0710107914 24.03.2015 Defer Date:18.11.2015

363

Case No.:29/5/82-

ALC4/2015
Party Name:ASSOCIATED DYESTUFF PVT. LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

364

Case No.:427/5/82-

ALC4/2015
Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

365

Case No.:431/5/82-

ALC4/2015
Party Name:EUROLIFE HEALTHCARE PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

366 Case No.:448/5/82- ALC4/2015
Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:10/82- ALC4/2015 Status:Case Deferred

15.10.2015 HQ File :01/82/050/00588/AM16/ RLA File :03/94/040/01211/AM15/ Lic.No/Date:0310795048 31.03.2015 Defer Date:18.11.2015

367

Case No.:16/5/82-

ALC4/2015
Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.35011/243/2015-PI(Norms) dt. 29.09.2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

368

Case No.:405/5/82-

ALC4/2015
Party Name:CTX LIFESCIENCES PVT LTD, Meet No/Date:10/82- ALC4/2015 15.10.2015 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: 18.11.2015 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.35011/413/2015-PI(Norms) dt. 01.09.2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

369

Case No.:438/5/82-

ALC4/2015
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00578/AM16/ RLA File :03/94/040/01196/AM15/ Lic.No/Date:0310795049 31.03.2015 Defer Date:18.11.2015

370

Case No.:19/5/82-

ALC4/2015
Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00159/AM16/
RLA File :08/24/040/00485/AM15/
Lic.No/Date:0810134977 31.03.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Mometasone Furoate based on the recommendation of

D/o Pharmaceuticals forwarded vide O.M. No.35011/241/2015-PI(Norms) dated 29.09.2015, uploaded along with these minutes or as

371

Case No.:27/5/82-

ALC4/2015
Party Name:POSY PHARMACHEM PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00167/AM16/ RLA File :08/24/040/00449/AM15/ Lic.No/Date:0810134978 31.03.2015 Defer Date:18.11.2015

372

Case No.:28/5/82-

ALC4/2015
Party Name:RUCHI SOYA INDUSTRIES LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : The Committee based on the written comments forwarded by the D/o C&PC, vide letter No.14010/31/2015-Ch-II dt.7.10.2015 2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

373

Case No.:24/5/82-

ALC4/2015
Party Name:SATYADEVA PHARMACEUTICALS /P/ LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00164/AM16/
RLA File :09/24/040/00729/AM15/
Lic.No/Date:0910061845 31.03.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product N-(N-Methyl-N.. based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/242/2015- PI(Norms) dated 29.09.2015 , uploaded along with these minutes or as applied by the firm per decision of NC.

374

Case No.:40/5/82-

ALC4/2015
Party Name:VASUDHA PHARMA CHEM LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00180/AM16/
RLA File :09/24/040/00691/AM15/
Lic.No/Date:0910061852 31.03.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Pantoprazole based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/256/2015-PI(Norms) dated 05.10.2015 , uploaded along with these minutes or as applied by the firm whichever is less

375

Case No.:10/4/82-

ALC4/2015
Party Name:VIRUPAKSHA ORGANICS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00049/AM16/
RLA File :09/24/040/00727/AM15/
Lic.No/Date:0910061808 31.03.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Sofosbuvir based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/179/2015-PI(Norms) dated 14.09.2015 , uploaded along with these minutes or as applied by the firm whichever is less

376

Case No.:11/4/82-

ALC4/2015
Party Name:VIRUPAKSHA ORGANICS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00050/AM16/
RLA File :09/24/040/00726/AM15/
Lic.No/Date:0910061807 31.03.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Sofosbuvir based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/179/2015-PI(Norms) dated 14.09.2015 , uploaded along with these minutes or as applied by the firm whichever is less

377

Case No.:12/5/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00152/AM16/
RLA File :09/24/040/00627/AM15/
Lic.No/Date:0910061822 31.03.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Reversacol Saddle brown based on the recommendation of D/o C&PC forwarded vide U.O. No. 14010/138/2011-Ch- II dated 14.09.2015, uploaded along with these minutes or as applied by the firm whichever is NC.

378

Case No.:432/5/82-

ALC4/2015
Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00572/AM16/ RLA File :03/94/040/01212/AM15/ Lic.No/Date:0310795110 06.04.2015 Defer Date:18.11.2015

379

Case No.:419/5/82-

ALC4/2015
Party Name:FDC LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00559/AM16/ RLA File :03/94/040/01173/AM15/ Lic.No/Date:0310795100 06.04.2015 Defer Date:18.11.2015

380

Case No.:449/5/82-

ALC4/2015
Party Name:INDOFIL INDUSTRIES LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00589/AM16/ RLA File :03/94/040/01208/AM15/ Lic.No/Date:0310795116 06.04.2015 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of Comments from DC&PC.

381

Case No.:416/5/82-

ALC4/2015
Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00556/AM16/ RLA File :03/94/040/01197/AM15/ Lic.No/Date:0310795139 07.04.2015 Defer Date:18.11.2015

382

Case No.:26/5/82-

ALC4/2015
Party Name:CONTINENTAL CHEMICALS Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

383

Case No.:411/5/82-

ALC4/2015
Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

384

Case No.:424/5/82-

ALC4/2015
Party Name:UNICHEM Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00564/AM16/
RLA File :03/95/040/01083/AM15/
Lic.No/Date:0310795220 09.04.2015 Defer Date: 27.11.2015

385

Case No.:406/5/82-

ALC4/2015
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00546/AM16/ RLA File :03/94/040/01225/AM15/ Lic.No/Date:0310795279 13.04.2015 Defer Date:18.11.2015

386

Case No.:139/8/82-

ALC4/2015
Party Name:S.M. CHEMICALS Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00935/AM16/ RLA File :03/95/040/01120/AM15/ Lic.No/Date:0310795271 13.04.2015 Defer Date:18.11.2015

387

Case No.:124/8/82-

ALC4/2015
Party Name:GUJARAT ORGANICS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00920/AM16/ RLA File :03/94/040/00664/AM15/ Lic.No/Date:0310795311 15.04.2015 Defer Date:15.10.2015 Decision : The Committee decided to ratify norms for the export product methyl Paraben based on the recommendation of D/o C&PC, forwarded vide U.O. No.14010/67/2011-Ch-II dated 30.09.2015 , 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.

388

Case No.:5/5/82-

ALC4/2015
Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. 35011/260/2015-PI(Norms) dt.29.09.2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

389

Case No.:6/5/82-

ALC4/2015
Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00146/AM16/
RLA File :08/24/040/00004/AM16/
Lic.No/Date:0810135050 17.04.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Beclomethasone

dipropionate based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/273/2015-PI(Norms) dated 01.09.2015 , uploaded along with these minutes or as

390

Case No.:10/5/82-

ALC4/2015
Party Name:PI INDUSTRIES LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00150/AM16/
RLA File :13/24/040/00056/AM15/
Lic.No/Date:1310047840 17.04.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product AE-473 based on the recommendation of D/o C&PC, forwarded vide U.O. No.15022/6/2010-Ch-II dated 30.09.2015 ,

391

Case No.:35/5/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

392

Case No.:32/5/82-

ALC4/2015
Party Name:LANTECH PHARMACEUTICALS LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00172/AM16/ RLA File :09/24/040/00011/AM16/ Lic.No/Date:0910061900 20.04.2015 Defer Date:18.11.2015 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.35011/259/2015-PI(Norms) dt. 29.09.2015. uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

393

Case No.:64/8/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00860/AM16/
RLA File :09/24/040/00006/AM16/
Lic.No/Date:0910061905 21.04.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Losartan Potassium based on the recommendation of

D/o Pharmaceuticals forwarded vide O.M. No.35011/165/2015-PI(Norms) dated October 2015, uploaded along with these minutes or as

394

Case No.:22/5/82-

ALC4/2015
Party Name:KLJ PLASTICIZERS LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00162/AM16/ RLA File :05/23/040/00587/AM15/ Lic.No/Date:0510393920 23.04.2015 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of Comments from

DC&PC(Petrochemicals).

395

Case No.:36/5/82-

ALC4/2015
Party Name:KLJ PLASTICIZERS LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00176/AM16/ RLA File :05/23/040/00597/AM15/ Lic.No/Date:0510393894 23.04.2015 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of Comments from DC&PC(Petrochemicals).

396

Case No.:115/7/82-

ALC4/2015
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00720/AM16/ RLA File :03/95/040/00042/AM16/ Lic.No/Date:0310795524 24.04.2015 Date:15.10.2015 Decision : The Committee decided to ratify norms for the export product Aromatice Derivative based on the recommendation of D/o C&PC, forwarded vide U.O. No.14010/95/2011-Ch-II dated 11.09.2015 , uploaded along with these minutes or as applied by the firm whichever is less

397

Case No.:40/8/82-

ALC4/2015
Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : It was decided to defer the case for want of Comments from DC&PC.

398

Case No.:35/8/82-

ALC4/2015
Party Name:EYTAN LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00831/AM16/ RLA File :09/24/040/00068/AM16/ Lic.No/Date:0910061940 28.04.2015 Defer Date:18.11.2015

399

Case No.:36/8/82-

ALC4/2015
Party Name:EYTAN LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00832/AM16/ RLA File :09/24/040/00067/AM16/ Lic.No/Date:0910061939 28.04.2015 Defer Date:18.11.2015

400

Case No.:17/5/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00157/AM16/ RLA File :05/24/040/00030/AM16/ Lic.No/Date:0510394006 28.04.2015 Defer Date:18.11.2015

401 Case No.:34/8/82- ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:10/82- ALC4/2015 Status:Case Approved

15.10.2015 HQ File :01/82/050/00830/AM16/
RLA File :09/24/040/00014/AM16/
Lic.No/Date:0910061946 29.04.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Reversacol Saddle brown based on the recommendation of D/o C&PC forwarded vide U.O. No. 14010/138/2011-Ch- II dated 14.09.2015, uploaded along with these minutes or as applied by the firm whichever is NC.

402

Case No.:174/5/82-

ALC4/2015
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

403

Case No.:176/5/82-

ALC4/2015
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

404

Case No.:177/5/82-

ALC4/2015
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

405

Case No.:62/8/82-

ALC4/2015
Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

406

Case No.:61/8/82-

ALC4/2015
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00857/AM16/ RLA File :09/24/040/00045/AM16/ Lic.No/Date:0910061970 01.05.2015 Defer Date:18.11.2015

407

Case No.:21/5/82-

ALC4/2015
Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00161/AM16/
RLA File :05/23/040/00003/AM16/
Lic.No/Date:0510394100 05.05.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Cefuroxime Axetil

based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No. 35011/403/2015-PI(Norms) dated 29.09.2015, 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.

408

Case No.:20/5/82-

ALC4/2015
Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00160/AM16/ RLA File :05/24/040/00040/AM16/ Lic.No/Date:0510394095 05.05.2015 Defer Date:18.11.2015

409

Case No.:37/5/82-

ALC4/2015
Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00177/AM16/
RLA File :05/24/040/00039/AM16/
Lic.No/Date:0510394094 05.05.2015 Defer Date: Decision: The Committee decided to ratify norms for the export product Atorvastatin Calcium
based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/141/2015- PI(Norms) dated October 2015 , uploaded along with these minutes or as applied by the firm per decision of NC.

410

Case No.:77/8/82-

ALC4/2015
Party Name:GRANULES INDIA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : It was decided to defer the case for want of Comments from DC&PC(Petorchemicals)

411

Case No.:78/8/82-

ALC4/2015
Party Name:GRANULES INDIA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : It was decided to defer the case for want of Comments from DC&PC(Petrochemicals)

412

Case No.:75/8/82-

ALC4/2015
Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

413

Case No.:65/8/82-

ALC4/2015
Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : It was decided to defer the case for want of Comments from DBT

414

Case No.:3/5/82-

ALC4/2015
Party Name:S.M. HERBALS PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00143/AM16/ RLA File :05/24/040/00014/AM16/ Lic.No/Date:0510394126 07.05.2015 Defer Date:18.11.2015

415

Case No.:7/5/82-

ALC4/2015
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : It was decided to defer the case for want of Comments from DC&PC

416

Case No.:38/8/82-

ALC4/2015
Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

417

Case No.:69/8/82-

ALC4/2015
Party Name:SRINI PHARMACEUTICALS LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00865/AM16/ RLA File :09/24/040/00742/AM15/ Lic.No/Date:0910061999 08.05.2015 Defer Date:18.11.2015

418

Case No.:2/5/82-

ALC4/2015
Party Name:UNITED BIOTECH PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00142/AM16/ RLA File :05/24/040/00009/AM16/ Lic.No/Date:0510394187 11.05.2015 Defer Date:18.11.2015

419

Case No.:76/8/82-

ALC4/2015
Party Name:AKTINOS PHARMA PVT LTD, Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

420

Case No.:91/8/82-

ALC4/2015
Party Name:MEDREICH LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00887/AM16/ RLA File :07/24/040/00025/AM16/ Lic.No/Date:0710108182 12.05.2015 Defer Date:18.11.2015

421

Case No.:94/8/82-

ALC4/2015
Party Name:PI INDUSTRIES LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00890/AM16/ RLA File :13/24/040/00005/AM16/ Lic.No/Date:1310047866 12.05.2015 Defer Date:18.11.2015

422

Case No.:95/8/82-

ALC4/2015
Party Name:PI INDUSTRIES LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00891/AM16/ RLA File :13/24/040/00004/AM16/ Lic.No/Date:1310047865 12.05.2015 Defer Date:18.11.2015 Decision : : It was decided to defer the case for want of Comments from DC&PC(Chemicals)

423

Case No.:31/8/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00827/AM16/ RLA File :09/24/040/00083/AM16/ Lic.No/Date:0910062012 13.05.2015

Date:15.10.2015 Decision : : It was decided to defer the case for want of Comments from DC&PC(Chemicals)

424

Case No.:32/8/82-

ALC4/2015
Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : : It was decided to defer the case for want of Comments from DC&PC(Chemicals)

425

Case No.:30/8/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00826/AM16/ RLA File :09/24/040/00058/AM16/ Lic.No/Date:0910062018 14.05.2015 Defer Date:18.11.2015 Decision : : It was decided to defer the case for want of Comments from DoP.

426

Case No.:41/8/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00837/AM16/ RLA File :09/24/040/00074/AM16/ Lic.No/Date:0910062016 14.05.2015 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of Comments from DoP.

42 7

Case No.:46/8/82-

ALC4/2015
Party Name:SMILAX LABORATORIES LIMI TED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Ca se Approved HQ File :01/82/050/00842/AM 16/
RLA File :09/24/040/00027/AM16/
Lic.No/Date:0910062 040 19.05.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Clopidogrel Camphorsulfonate based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.

No. 35011/189/2015-PI(Norms) dated October 2015, uploaded along with these minutes or as

428

Case No.:42/8/82-

ALC4/2015
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

429

Case No.:199/5/82-

ALC4/2015
Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

430

Case No.:200/5/82-

ALC4/2015
Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

431

Case No.:66/8/82-

ALC4/2015
SCIENCES LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00862/AM16/
RLA File :09/24/040/00084/AM16/
Lic.No/Date:0910062054 21.05.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Methyl ( E ) based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No. 35011/275/2015- PI(Norms) dated October 2015, uploaded along with these minutes or as applied by the firm per decision of NC.

432

Case No.:97/8/82-

ALC4/2015
Party Name:ASCENT FINECHEM PVT. LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : The Committee based on the written comments forwarded by the D/o C&PC vide U.O.No.14010/1/2012-CH-II dt.07.10.2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

433

Case No.:140/8/82-

ALC4/2015
Party Name:SAIBABA SURFACTANTS (P) LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred

HQ File :01/82/050/00936/AM16/ RLA File :08/24/040/00015/AM16/ Lic.No/Date:0810135345 22.05.2015 Defer Date:18.11.2015

434

Case No.:29/8/82-

ALC4/2015
Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

435

Case No.:45/8/82-

ALC4/2015
Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

436

Case No.:136/8/82-

ALC4/2015
Party Name:SEBACIC INDIA LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00932/AM16/ RLA File :34/24/040/00049/AM16/ Lic.No/Date:3410041253 28.05.2015 Defer Date:18.11.2015

437

Case No.:86/8/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

438

Case No.:90/8/82-

ALC4/2015
Party Name:UNITED BIOTECH PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

439

Case No.:7/8/82-

ALC4/2015
Party Name:RAMPEX LABS PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

440

Case No.:59/7/82-

ALC4/2015
Party Name:GRANULES INDIA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File RLA File Lic.No/Date:0910062152 Defer

:01/82/050/00664/AM16/ :09/24/040/00149/AM16/ 10.06.2015 Date:18.11.2015 Decision : It was decided to defer the case for want of Comments from DC&PC(Petrochemicals)

441

Case No.:59/8/82-

ALC4/2015
Party Name:GRANULES INDIA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00855/AM16/ RLA File :09/24/040/00140/AM16/ Lic.No/Date:0910062148 10.06.2015 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of Comments from DC&PC(Petrochemicals)

442

Case No.:68/8/82-

ALC4/2015
Party Name:GRANULES INDIA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00864/AM16/ RLA File :09/24/040/00156/AM16/ Lic.No/Date:0910062147 10.06.2015 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of Comments from DC&PC(Petrochemicals)

443

Case No.:74/8/82-

ALC4/2015
Party Name:GRANULES INDIA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : It was decided to defer the case for want of Comments from DC&PC(Petrochemicasl)

444

Case No.:88/8/82-

ALC4/2015
Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00884/AM16/ RLA File :31/83/040/00005/AM16/ Lic.No/Date:3110065476 16.06.2015 Defer Date:18.11.2015 Decision : The Committee based on the written comments forwarded by the D/o C&PC, letter No.14010/3/2012-Ch-II dated 29.09.2015 uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

445

Case No.:185/5/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00325/AM16/
RLA File :09/24/040/00161/AM16/
Lic.No/Date:0910062185 16.06.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Levetiracetam based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/247/2015- PI(Norms) dated Sept. 2015 , uploaded along with these minutes or as applied by the firm per decision of NC.

446

Case No.:186/5/82-

ALC4/2015
Party Name:DR REDDYS Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred

HQ File :01/82/050/00326/AM16/
RLA File :09/24/040/00150/AM16/
Lic.No/Date:0910062206 17.06.2015 Defer Date:

447

Case No.:189/5/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00329/AM16/ RLA File :09/24/040/00163/AM16/ Lic.No/Date:0910062218 19.06.2015 Defer Date:18.11.2015

448

Case No.:454/5/82-

ALC4/2015
Party Name:CADILA HEALTHCARE LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00594/AM16/
RLA File :08/24/040/00081/AM16/
Lic.No/Date:0810135519 22.06.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Buspirone Hydrochloride tablets on repeat basis as per earlier decision taken by NC in its meeting No.15/82 dated 12.1.2015 uploaded along with these minutes or as applied by the firm whichever is less

449

Case No.:455/5/82-

ALC4/2015
Party Name:CADILA HEALTHCARE LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00595/AM16/
RLA File :08/24/040/00082/AM16/
Lic.No/Date:0810135520 22.06.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Potassium Citrate Extended release tablest on repeat basis as per earlier decision taken by NC in its meeting No.23/82 dated 06.03.2014 uploaded along with these minutes or as applied by the firm per decision of NC.

450

Case No.:108/8/82-

ALC4/2015
Party Name:METROPOLITAN EXIMCHEM LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00904/AM16/ RLA File :03/95/040/00041/AM16/ Lic.No/Date:0310796749 22.06.2015 Defer Date:18.11.2015 Decision : The Committee based on the written comments forwarded by the D/o C&PC, letter No.14010/40/2012-Ch-II dated 07.10.2015 uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

451

Case No.:2/6/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00598/AM16/
RLA File :09/24/040/00165/AM16/
Lic.No/Date:0910062242 23.06.2015 Defer Date: Decision The Committee decided to ratify norms for the export product Paroxetine hydrochloride Hemihydrate based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No. 35011/276/2015-PI(Norms) dated Sept. 2015, uploaded along with these minutes or as applied

by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

452

Case No.:1/6/82-

ALC4/2015
Party Name:HERBOCHEM Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00597/AM16/ RLA File :09/24/040/00148/AM16/ Lic.No/Date:0910062238 23.06.2015 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of Comments from DC&PC

453

Case No.:121/8/82-

ALC4/2015
Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

45 4 Case No.:110/8/82- ALC4/2015
Party Name:MAC CHEM PRODUCTS (INDIA) PRI VATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Cas e Deferred HQ File :01/82/050/00906/ AM16/
RLA File :03/95/040/00205/AM16/
Lic.No/Date:03107 96822 24.06.2015 Defer Date:18.11. 2015

455

Case No.:107/8/82-

ALC4/2015
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00903/AM16/ RLA File :03/95/040/00084/AM16/ Lic.No/Date:0310796841 24.06.2015 Defer Date:18.11.2015

456

Case No.:111/8/82-

ALC4/2015
Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00907/AM16/ RLA File :03/95/040/00184/AM16/ Lic.No/Date:0310796820 24.06.2015 Defer Date:18.11.2015

457

Case No.:100/8/82-

ALC4/2015
Party Name:REANNON PHARMACEUTICALS Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00896/AM16/
RLA File :03/95/040/00134/AM16/
Lic.No/Date:0310796838 24.06.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Renontrikal Injection based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No. 35011/50/2015- PI(Norms) dated Sept. 2015, uploaded along with these minutes or as applied by the firm

per decision of NC.

458

Case No.:56/8/82-

ALC4/2015
Party Name:TRIMAX BIO SCIENCES PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00852/AM16/ RLA File :09/24/040/00718/AM15/ Lic.No/Date:0910062245 24.06.2015 Defer Date:18.11.2015 Decision :It was decided to defer the case for want of comments of DC&PC(Chemicals)

459

Case No.:3/6/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00599/AM16/
RLA File :09/24/040/00179/AM16/
Lic.No/Date:0910062259 30.06.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Valacyclovir Hcl based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/276/2015- PI(Norms) dated Sept. 2015 , uploaded along with these minutes or as applied by the firm per decision of NC.

460

Case No.:4/6/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

461

Case No.:89/8/82-

ALC4/2015
Party Name:CATAPHARMA CHEMICALS PVT. LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00885/AM16/ RLA File :31/83/040/00027/AM16/ Lic.No/Date:3110065523 01.07.2015 Defer Date:18.11.2015 Decision : The Committee considered the case for ratification of norms as per agenda. Since the export product and import item has same description and chemical compound, the committee decided that while fixing wastage it is necessary to specify the purity of export and import items in the comments of each case. DC&PC may accordingly furnish revised recommendations. The committee accordingly decided to defer the case.

462

Case No.:5/6/82-

ALC4/2015
Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : It was decided to defer the case for want of comments of DC&PC(Chemicals)

463

Case No.:109/8/82-

ALC4/2015
Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

464

Case No.:9/6/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00605/AM16/ RLA File :09/24/040/00176/AM16/ Lic.No/Date:0910062314 07.07.2015 Defer Date:18.11.2015

465

Case No.:98/8/82-

ALC4/2015
Party Name:HONEST BIO-VET PVT. LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

466

Case No.:104/8/82-

ALC4/2015
Party Name:POLYDRUG LABORATORIES PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00900/AM16/
RLA File :03/95/040/00219/AM16/
Lic.No/Date:0310797101 07.07.2015 Defer Date: Decision The Committee decided to ratify norms for the export product Metoprolol base based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/415/2015- PI(Norms) dated October 2015 , uploaded along with these minutes or as applied by the firm per decision of NC.

467

Case No.:129/8/82-

ALC4/2015
Party Name:SUPREET CHEMICALS PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00925/AM16/ RLA File :03/95/040/00237/AM16/ Lic.No/Date:0310797113 08.07.2015 Defer Date:18.11.2015

468

Case No.:57/8/82-

ALC4/2015
Party Name:JAGSONPAL PHARMACEUTICALS LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00853/AM16/
RLA File :05/23/040/00114/AM16/
Lic.No/Date:0510394864 09.07.2015 Defer Date: 27.11.2015 Decision : It was decided to defer the case for want of comments of DoP.

469

Case No.:54/8/82-

ALC4/2015
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

Decision : It was decided to defer the case for want of comments of DoP

470

Case No.:50/8/82-

ALC4/2015
Party Name:PUSILIN BIOTECHNOLOGY PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

471

Case No.:103/8/82-

ALC4/2015
Party Name:SUNSHIELD CHEMICALS LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00899/AM16/ RLA File :03/95/040/00266/AM16/ Lic.No/Date:0310797135 09.07.2015 Date:15.10.2015 Decision : The Committee decided to ratify norms for the export product Theic - Tris (2-Hydroxy Ethyl Isocyanurate based on the recommendation of D/o C&PC, forwarded vide U.O. No. 14010/107/2010-Ch-II dated 22.7.2015, 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.

472

Case No.:106/8/82-

ALC4/2015
Party Name:LUPIN LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00902/AM16/ RLA File :03/95/040/00149/AM16/ Lic.No/Date:0310797161 10.07.2015 Defer Date:18.11.2015

473

Case No.:58/8/82-

ALC4/2015
Party Name:INDO PHYTO CHEMICALS PVT LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00854/AM16/ RLA File :05/23/040/00069/AM16/ Lic.No/Date:0510394892 14.07.2015 Defer Date:18.11.2015

474

Case No.:72/8/82-

ALC4/2015
Party Name:INDO PHYTO CHEMICALS PVT LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00868/AM16/ RLA File :05/23/040/00068/AM16/ Lic.No/Date:0510394891 14.07.2015 Defer Date:18.11.2015

475

Case No.:85/8/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00881/AM16/ RLA File :05/24/040/00167/AM16/ Lic.No/Date:0510394902 15.07.2015 Defer Date:18.11.2015

476 Case No.:113/8/82- Party Name:UNIJULES Meet No/Date:10/82- Status:Case

ALC4/2015
LIFE SCIENCES LTD. ALC4/2015 15.10.2015 Deferred HQ File :01/82/050/00909/AM16/ RLA File :03/95/040/00299/AM16/ Lic.No/Date:0310797251 15.07.2015 Defer Date:18.11.2015

477

Case No.:70/8/82-

ALC4/2015
Party Name:ZEISS PHARMACEUTICALS PVT.LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

478

Case No.:52/8/82-

ALC4/2015
Party Name:AMI ORGANICS PVT LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00848/AM16/ RLA File :52/24/040/00026/AM16/ Lic.No/Date:5210041581 16.07.2015 Defer Date:18.11.2015

479

Case No.:49/8/82-

ALC4/2015
Party Name:M.L.A. INDUSTRIES Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : It was decided to defer the case for want of comments of DC&PC

480

Case No.:120/8/82-

ALC4/2015
Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

481

Case No.:116/8/82-

ALC4/2015
Party Name:PRASOL CHEMICALS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00912/AM16/ RLA File :03/95/040/00216/AM16/ Lic.No/Date:0310797284 16.07.2015 Defer Date:18.11.2015

482

Case No.:93/8/82-

ALC4/2015
Party Name:DR J PHARMACHEM (INDIA)(PROP.ADITYA PRAMOD JOGDEO) Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00889/AM16/ RLA File :31/83/040/00050/AM16/ Lic.No/Date:3110065541 17.07.2015 Defer Date:18.11.2015

483 Case No.:55/8/82- Party Name:JUBILANT Meet No/Date:10/82- Status:Case

ALC4/2015
LIFE SCIENCES LIMITED ALC4/2015 15.10.2015 Deferred HQ File :01/82/050/00851/AM16/ RLA File :05/23/040/00142/AM16/ Lic.No/Date:0510394969 17.07.2015 Defer Date:18.11.2015

484

Case No.:44/8/82-

ALC4/2015
Party Name:SUBHASH CHEMICAL INDUSTRIES PVT LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00840/AM16/ RLA File :31/83/040/00057/AM16/ Lic.No/Date:3110065540 17.07.2015 Defer Date:18.11.2015

485

Case No.:84/8/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00880/AM16/ RLA File :05/24/040/00121/AM16/ Lic.No/Date:0510394909 17.07.2015 Defer Date:18.11.2015

486

Case No.:102/8/82-

ALC4/2015
Party Name:LUPIN LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00898/AM16/ RLA File :03/95/040/00297/AM16/ Lic.No/Date:0310797490 21.07.2015 Defer Date:18.11.2015

487

Case No.:122/8/82-

ALC4/2015
Party Name:LUPIN LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00918/AM16/ RLA File :03/95/040/00300/AM16/ Lic.No/Date:0310797471 21.07.2015 Defer Date:18.11.2015

488

Case No.:123/8/82-

ALC4/2015
Party Name:LUPIN LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00919/AM16/ RLA File :03/95/040/00298/AM16/ Lic.No/Date:0310797489 21.07.2015 Defer Date:18.11.2015

489

Case No.:71/8/82-

ALC4/2015
Party Name:KLJ PLASTICIZERS LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00867/AM16/ RLA File :05/23/040/00161/AM16/ Lic.No/Date:0510395027 22.07.2015 Defer Date:18.11.2015 Decision : It was decided to defer the case for want of comments of DC&PC(Petrochemicals)

490 Case No.:83/8/82- ALC4/2015
Party Name:VARUN MEDIMPEX INC. Meet No/Date:10/82- ALC4/2015 Status:Case Deferred

15.10.2015 HQ File :01/82/050/00879/AM16/ RLA File :05/24/040/00195/AM16/ Lic.No/Date:0510395044 22.07.2015 Defer Date:18.11.2015

491

Case No.:1/8/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00797/AM16/ RLA File :09/24/040/00236/AM16/ Lic.No/Date:0910062367 23.07.2015 Defer Date:18.11.2015

492

Case No.:2/8/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

493

Case No.:3/8/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

494

Case No.:4/8/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

495

Case No.:80/8/82-

ALC4/2015
Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00876/AM16/
RLA File :05/24/040/00192/AM16/
Lic.No/Date:0510395055 23.07.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Atorvastatin Calcium based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/141/2015- PI(Norms) dated October 2015 , uploaded along with these minutes or as applied by the firm per decision of NC.

496

Case No.:119/8/82-

ALC4/2015
Party Name:SI GROUP INDIA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00915/AM16/
RLA File :03/95/040/00322/AM16/
Lic.No/Date:0310797595 23.07.2015 Defer Date:

497

Case No.:79/8/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

498

Case No.:10/8/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

499

Case No.:115/8/82-

ALC4/2015
Party Name:MERCK LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

500

Case No.:117/8/82-

ALC4/2015
Party Name:PRASOL CHEMICALS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00913/AM16/ RLA File :03/95/040/00250/AM16/ Lic.No/Date:0310797677 27.07.2015 Defer Date:18.11.2015

501

Case No.:11/8/82-

ALC4/2015
Party Name:INTER LABS (INDIA)PVT LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

502

Case No.:118/8/82-

ALC4/2015
Party Name:ORION CHEM PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00914/AM16/ RLA File :03/95/040/00337/AM16/ Lic.No/Date:0310797764 28.07.2015 Defer Date:18.11.2015

503

Case No.:73/8/82-

ALC4/2015
Party Name:RECKITT BENCKISER HEALTHCARE INDIA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

504

Case No.:1/10/82-

ALC4/2015
Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

505

Case No.:12/8/82-

ALC4/2015
Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

506

Case No.:13/8/82-

ALC4/2015
Party Name:HETERO DRUGS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

507

Case No.:14/8/82-

ALC4/2015
Party Name:HETERO DRUGS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

508

Case No.:15/8/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00811/AM16/ RLA File :09/24/040/00261/AM16/ Lic.No/Date:0910062400 29.07.2015 Defer Date:18.11.2015

509

Case No.:99/8/82-

ALC4/2015
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00895/AM16/ RLA File :03/95/040/00313/AM16/ Lic.No/Date:0310797796 29.07.2015 Defer Date:18.11.2015

510

Case No.:16/8/82-

ALC4/2015
Party Name:AKTINOS PHARMA PVT LTD, Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

511

Case No.:37/8/82-

ALC4/2015
Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Approved HQ File :01/82/050/00833/AM16/
RLA File :05/23/040/00183/AM16/
Lic.No/Date:0510395134 30.07.2015 Defer Date: Decision : The Committee decided to ratify norms for the export product Ceftibuten based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/224/2015-PI(Norms) dated 29.09.2015 , uploaded along with these minutes or as applied by the firm whichever is NC.

512

Case No.:17/8/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

513

Case No.:96/8/82-

ALC4/2015
Party Name:OTSUKA CHEMICAL ( INDIA ) PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00892/AM16/ RLA File :05/24/040/00216/AM16/ Lic.No/Date:0510395233 06.08.2015 Defer Date:18.11.2015 Decision : : It was decided to defer the case for want of comments of DC&PC(Chemicals)

514

Case No.:19/8/82-

ALC4/2015
Party Name:HETERO DRUGS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

515

Case No.:18/8/82-

ALC4/2015
Party Name:HONOUR LAB LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00814/AM16/ RLA File :09/24/040/00270/AM16/ Lic.No/Date:0910062454 07.08.2015 Defer Date:18.11.2015

516

Case No.:23/8/82-

ALC4/2015
Party Name:ALPHAMED FORMULATIONS P LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : : It was decided to defer the case for want of comments of DC&PC(Chemicals)

517

Case No.:22/8/82-

ALC4/2015
Party Name:GRANULES INDIA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File RLA File Lic.No/Date:0910062467 Defer

:01/82/050/00818/AM16/ :09/24/040/00287/AM16/ 11.08.2015 Date:18.11.2015 Decision : : It was decided to defer the case for want of comments of DC&PC(Petrochemicals)

518

Case No.:25/8/82-

ALC4/2015
Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : : It was decided to defer the case for want of comments of DC&PC(Chemicals)

519

Case No.:24/8/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00820/AM16/ RLA File :09/24/040/00262/AM16/ Lic.No/Date:0910062490 13.08.2015 Defer Date:18.11.2015

520

Case No.:27/8/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00823/AM16/ RLA File :09/24/040/00271/AM16/ Lic.No/Date:0910062515 18.08.2015 Defer Date:18.11.2015

521

Case No.:26/8/82-

ALC4/2015
Party Name:HONOUR LAB LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

522

Case No.:28/8/82-

ALC4/2015
Party Name:HETERO DRUGS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

523

Case No.:133/8/82-

ALC4/2015
Party Name:AKTINOS HEALTHCARE PRIVATE LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015 Decision : : It was decided to defer the case for want of comments of DC&PC(Chemicals)

524

Case No.:131/8/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

525

Case No.:132/8/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

526

Case No.:134/8/82-

ALC4/2015
Party Name:HETERO DRUGS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

527

Case No.:4/10/82-

ALC4/2015
Party Name:HETERO DRUGS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

528

Case No.:3/10/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00959/AM16/ RLA File :09/24/040/00378/AM16/ Lic.No/Date:0910062661 24.09.2015 Defer Date:18.11.2015

529

Case No.:2/10/82-

ALC4/2015
Party Name:HONOUR LAB LIMITED Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

530

Case No.:5/10/82-

ALC4/2015
Party Name:CONCORD BIOTECH LTD Meet No/Date:10/82- ALC4/2015 15.10.2015 Status:Case Deferred HQ File :01/82/050/00961/AM16/ RLA File :08/24/040/00181/AM16/ Lic.No/Date:0810136115 28.09.2015 Defer Date:18.11.2015

531

Case No.:6/10/82-

ALC4/2015
Party Name:ARCHIMEDIS LABORATORIES PVT. LTD. Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

Decision : : It was decided to defer the case for want of comments of DC&PC(Chemicals)

532

Case No.:7/10/82-

ALC4/2015
Party Name:DIVIS LABORATORIES LTD., Meet No/Date:10/82- ALC4/2015 15.10.2015 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:18.11.2015

Manual Agenda of NC Meeting No. 10/82/2015 Scheduled to be held on 15.10.2015

Case No. B- 01

M.No.10/16 Date 15.10.2015

M/s. Organica Aromatics Pvt Ltd File No. 01/82/050/01612/AM 09 RLA No.07/24/040/00564/AM 09 Adv.Auth. No. 0710062745 dt. 04.02.2009

Decision: The Committee considered the case for revision of norms as per agenda. The Committee decided to defer the case.

Case No. B- 02

M.No.10/16 Date 15.10.2015

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 dt. 27.11.2007

Decision: The Committee considered the case for revision of norms as per agenda. The Committee decided to defer the case. The Committee decided to send a copy of representation to DBT and deferred the case.

Case No. B- 03

M.No.10/16 Date 15.10.2015

M/s. Lotus Enterprise
File No.01/82/050/01148/AM 07 RLA No.03/95/040/00588/AM 07 Adv.Auth. No.0310403889 dt 12.09.2006

Decision: The Committee considered the case for correction in the description of export product from “Acid Blue 25-200% (Dye content 70-72%)” to “Acid Blue 25 SPL” as per agenda. The Committee decided to correct the description of export product as per recommendation of DC&PC uploaded along with these minutes to read as “Acid Blue 25 SPL” for EODC/Regularisation purpose only, without any change in the norms.
RA concerned may take further necessary action as per decision of NC.

Case No. B- 04

M.No.10/16 Date 15.10.2015

M/s. Gopinath Chem tech Ltd File No.01/82/050/01421/AM 11 RLA No.08/24/040/00270/AM11 Adv.Auth. No.0810094594 dt 13.12.2010

Decision: The Committee considered the case for ratification of norms as per agenda under Para

4.07 of HBP. The Committee decided to defer the case as the representative from the Deptt. of Chemical and Petrochemical was not present in the meeting to explain the reasons for enhancement of the quantity of raw materials against the said advance licence.

Case No. B- 05

M.No.10/16 Date 15.10.2015

M/s. Gopinath Chem tech Ltd File No.01/82/050/00562/AM 14 RLA No.08/24/040/00231/AM14 Adv.Auth. No.0810124122 dt 26.08.2013

Decision: Decision: The Committee considered the case for ratification of norms as per agenda under Para 4.07 of HBP. The Committee decided to defer the case as the representative from the Deptt. of Chemical and Petrochemical was not present in the meeting to explain the reasons for enhancement of the quantity of raw materials against the said advance licence..

Case No. B- 06

M.No.10/16 Date 15.10.2015

M/s. Gopinath Chem tech Ltd File No.01/82/050/00104/AM 14 RLA No.08/24/040/00436/AM13 Adv.Auth. No.0810119304 dt 13.03.2013 Decision: The Committee considered the case for ratification of norms as per agenda under Para 4.07 of HBP. The Committee decided to defer the case as the representative from the Deptt. of Chemical and Petrochemical was not present in the meeting to explain the reasons for enhancement of the quantity of raw materials against the said advance licence.

Case No. B- 07

M.No.10/16 Date 15.10.2015

M/s. FDC Ltd File No.01/82/050/01201/AM 15 RLA No.03/94/040/00259/AM15 Adv.Auth. No.0310788130 dt 19.08.2014

Decision: The Committee considered the case for ratification of norms for the export product as per agenda under Para 4.07 of HBP.

The Committee decided to defer the case as the representative of DoP present in the meeting would furnishing comment.

Case No. B- 08

M.No.10/16 Date 15.10.2015

M/s. Melzer Chemicals Pvt Ltd File No.01/82/050/00363/AM 13 RLA No.31/83/040/00060/AM13 Adv.Auth. No.3110054836 dt. 26.06.2012 Decision: The Committee considered the case for ratification of norms for the export product Hexahydro-1,3,5-Tris (2-Hydroxyethyl)-S-triazine as per agenda under Para 4.07 of HBP.

The Committee in light of earlier decision taken by NC in its meeting No.1/82/2014 dated 10.04.2014 uploaded along with these minutes decided to ratify norms on repeat basis or as applied by the firm whichever is less.

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

Case No. B- 09

M.No.10/16 Date 15.10.2015

M/s. Melzer Chemicals Pvt Ltd File No.01/82/050/00974/AM 13 RLA No.31/83/040/00134/AM13 Adv.Auth. No.3110056196 dt. 05.11.2012

Decision: The Committee considered the case for ratification of norms for the export product Hexahydro-1,3,5-Tris (2-Hydroxyethyl)-S-triazine as per agenda under Para 4.07 of HBP.

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

Case No. B- 10

M.No.10/16 Date 15.10.2015

M/s. Unichem Laboratories Ltd File No.01/82/050/00002/AM 16 RLA No.03/95/040/00884/AM15 Adv.Auth. No.0310793384 dt. 29.01.2015 Decision: The Committee considered the case for correction in UOM of export product Clopidogrel 75 MG Table as per agenda. The Committee decided to amend the UOM of export product Clopidogrel 75 MG Tablet to read as 1Number.

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

Case No. B- 11

M.No.10/16 Date 15.10.2015

M/s. Camphor & Allied Products Ltd File No.01/82/050/01098/AM 14 RLA No.03/94/040/00715/AM14 Adv.Auth. No.0310762311 dt. 18.12.2013

Decision: The Committee considered the case for correction in import items No.2 of norms already ratified by NC in its meeting No.01/82 dated 14.08.2015. The committee decided to defer the case as no comments were received from technical authority.

Case No. B- 12

M.No.10/16 Date 15.10.2015

M/s. Camphor & Allied Products Ltd File No.01/82/050/00950/AM 14 RLA No.03/94/040/00626/AM14 Adv.Auth. No.0310754842 dt. 22.10.2013

Decision: The Committee considered the case for correction in import items already ratified by NC in its meeting No.19/82 dated 02.1.2014. The committee decided to defer the case as no comments were received from technical authority.

Case No. B- 13

M.No.10/16 Date 15.10.2015 M/s. Camphor & Allied Products Ltd File No.01/82/050/00741/AM 13 RLA No.03/94/040/00222/AM13

Adv.Auth. No.0310706272 dt. 24.08.2012 Decision: The Committee considered the case for correction in import items already ratified by NC in its meeting No.22/82 dated 18.10.2012. The committee decided to defer the case as no comments were received from technical authority.

Case No. B- 14

M.No.10/16 Date 15.10.2015

M/s. Camphor & Allied Products Ltd File No.01/82/050/00623/AM 13 RLA No.03/94/040/00363/AM13 Adv.Auth. No.0310704836 dt. 10.08.2012 Decision: The Committee considered the case for correction in import items already ratified by NC in its meeting No.22/82 dated 18.10.2012. The committee decided to defer the case as no comments were received from technical authority.

Case No. B- 15

M.No.10/16 Date 15.10.2015

M/s. Camphor & Allied Products Ltd File No.01/82/050/01071/AM 13 RLA No.03/94/040/00543/AM13 Adv.Auth. No.0310712193 dt. 9.10.2012 Decision: The Committee considered the case for mentioning quantity of import items Norms already ratified by NC in its meeting No.31/82 dated 21.2.2013. The committee decided to defer the case as no comments were received from technical authority.

Case No. B- 16

M.No.10/16 Date 15.10.2015

M/s. DSM Sinochem Pharmaceuticals India Pvt Ltd File No.01/82/050/00645/AM 07 RLA No.22/24/040/00152/AM07 Adv.Auth. No.2210005831 dt. 31.07.2006

Decision: The Committee considered the case of revision of norms for the export product as per agenda under para 4.07 of HBP. The Committee decided to call for complete set of application from the firm and deferred the case.

Case No. B- 17

M.No.10/16 Date 15.10.2015

File No.01/82/050/00056/AM 08 RLA No.22/21/042/00006/AM 05 Adv.Auth. No.2210006467 dt. 02.02.2007

Case No. B- 18

M.No.10/16 Date 15.10.2015

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

Case No. B- 19

M.No.10/16 Date 15.10.2015

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

Case No. B- 20

M.No.10/16 Date 15.10.2015

File No.01/82/050/00253/AM 08 RLA No.22/24/040/00007/AM 08 Adv.Auth. No.2210006705 dt. 03.05.2007

Case No. B- 21

M.No.10/16 Date 15.10.2015

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

Case No. B- 22

M.No.10/16 Date 15.10.2015

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

Case No. B- 23

M.No.10/16 Date 15.10.2015

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

Case No. B- 24

M.No.10/16 Date 15.10.2015

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

Case No. B- 25

M.No.10/16 Date 15.10.2015

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

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Office of Directorate General of Foreign Trade New Delhi -110011

Para 4.7 Decision

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

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

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Office of Directorate General of Foreign Trade
New Delhi -110011