IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2015-06-25

DGFT Committee Minutes

Document text

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Office of Directorate General of Foreign Trade
New Delhi

Para 4.7 Decision (Norms Committee - III)

MEETING NUMBER
: 5/82-ALC4/2015 MEETING DATE : 25.06.2015

Meeting No. 05/82/2015 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 25.06.2015 but actually held on 05.08.2015 under the Chairmanship of Dr. S.K. Bansal, Jt. DGFT in Room No.11, Udyog Bhawan, New Delhi.

Following members were present:-

Shri A.K. Agarwal, Addl. Ind. Adviser, Department of C&PC
Shri O.P. Sharma, Joint Industrial Adviser, Department of C&PC Shri D.N. Mathur, Consultant, Department of Pharmaceutical
Shri Mahendra Vikram Singh, Foreign Trade Development Officer

The committee went through the minutes of earlier NC–III meeting No. 04/82 dated 12.06.2015 but actually held on 24.06.2015 and approved the same.

The following cases/issues were discussed and the committee took the decision as mentioned against each case. 1

Case No.:132/8/82-ALC4/2014 Party Name:PROVENTUS

LIFE SCIENCES PRIVATE LIMITED, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00796/AM15/
RLA File :04/24/040/00395/AM08/
Lic.No/Date:0410094357 12.03.2008 Defer Date 16.09.2015

Decision : The Committee observed that firm was requested to furnish Production and Consumption data duly certified by Central Excise Authority in its meeting held on 29.04.2015 but same has not received so far. The Committee decided to remind the firm to furnish required information immediately and defer the case.

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Case No.:353/5/82-ALC4/2015 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00493/AM16/
RLA File :03/95/040/00130/AM11/
Lic.No/Date:0310575673 24.05.2010 Defer Date 16.09.2015

Decision : The Committee consider the case for ratification of norms and decided to defer the case for want of comments from D/o C&PC (Chemicals).

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Case No.:14/24/82-

ALC4/2010
Party Name:SAINOR LABORATORIES PVT LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred

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HQ File :01/82/050/00814/AM11/
RLA File :09/24/040/00210/AM11/
Lic.No/Date:0910043414 08.09.2010 Defer Date 16.09.2015

the case for want of comments from D/o C&PC (Chemicals).

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Case No.:47/5/82-ALC4/2015 Party Name:SATYA

DEEPTHA PHARMACEUTICALS LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00187/AM16/
RLA File :09/24/040/00009/AM13/
Lic.No/Date:0910052284 24.04.2012

Decision : The committee decided to ratify the norms based on the recommendation of Department of Pharmaceuticals vide O.M.No35011/793/2013-PI (Norms) dt. August 2014 as per details given below or as applied by the firm whichever is less:-
Export product Qty. Import items Qty. in kg (1S, 4R)-4-(2-AMINO-6-CHLORO- 5-FORMAMIDO-4- PYRIMIDINYL)AMINO--2- CYCLOPENTENE-1-METHANOL 1kg N-(2-AMINO-4,6-DICHLORO-5- PYRIMIDINYL) FORMAMIDE
0.764 (+)-2-AZABICYCLO[2.2.1]HEPT- EN-3-ONE (VANCELACTAM)
1.832 D(-)TARTARIC ACID 1.06 SODIUM BOROHYDRIDE 0.226 ISOPROPYL ALCOHOL 4.70 METHANOL 4.23 DICHLORO METHANE 2.47 RA may take further action accordingly.

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Case No.:30/13/82-ALC4/2012 Party Name:HALDIA

PETROCHEMICALS LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00365/AM13/
RLA File :02/24/040/00029/AM13/
Lic.No/Date:0210177518 14.05.2012

Department of C&PC vide O.M.46011/54/2008-PC-II dt. 23.7.2015 as per details given below or as applied by the firm whichever is less:-
Export product Qty. Import item Qty.kg/kg Benzene (from Olefinic complex 1kg Naphtha 1.194

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Case No.:24/1/82-ALC4/2015 Party Name:VIJAYASRI

ORGANICS LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/01550/AM15/
RLA File :09/71/040/00073/AM13/
Lic.No/Date:0910053465 09.08.2012

Decision : The committee decided to ratify the norms based on written comments provided by

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technical authority from Department of Pharmaceuticals as per details given below or as applied by the firm whichever is less:-
Export product Qty. Import items Qty.kg/kg 4-FLUORO-a-2-METHYL-1- OXOPROPYL,)-G-OXO-N-B- DIPHENYL BENZENE BUTANEAMIDE (DIKETONE- INTERMEDIATE FOR ATORVASTATIN)/DKT-3 1kg
FLUOROBENZENE 0.52 METHELENE DICHLORIDE (MDC) 2.00 METHYL ISO BUTYRYL ACETATE (MIBA) 0.76 METHANOL 0.50

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Case No.:42/20/82-ALC4/2013 Party Name:GLAND

PHARMA LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred
HQ File :01/82/050/01028/AM14/
RLA File :09/24/040/00058/AM14/
Lic.No/Date:0910056110 23.05.2013 Defer Date 16.09.2015

Decision : The committee in light of the written comments of Department of Pharmaceuticals vide O.M.No35011/5/2014-PI (Norms) dt. 4.6.2015 decided to call for following information from the firm:-

  1. Literature reference about conversion of IUs to weight of various Low Molecular Weight Heparins i.e. Nadroparin, Enoxaprin and Dalteparin Sodium.
  2. Consumption data for all raw materials used in the production of Low Molecular Weight Heparin-dalteparin Sodium injections, duly certified from central excise authorities for the years 2012-13, 2013-14 and April to December 2014.
  3. Copies of batch log sheets for last 5 consecutive batches for conversion of Heparin powder into Dalteparin Sodium indicating the actual consumption of all raw materials consumed for getting the API used in the Dalteparin sodium injections.
  4. Copies of batch log sheets for last 5 consecutive batches indicating actual consumption of 16 raw materials applied for import in all applications against export of Low Molecular Weight Heparin Dalteparin Sodium injections in PFS.

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Case No.:173/5/82-ALC4/2015 Party Name:FORACE

POLYMERS (P) LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00313/AM16/
RLA File :05/23/040/00069/AM14/
Lic.No/Date:0510356983 13.06.2013 Defer Date 16.09.2015

the case for want of comments from D/o C&PC Chemicals.

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Case No.:131/3/82-ALC4/2014 Party Name:ASTRIX

LABORATORIES LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Status: Reject HQ File :01/82/050/00135/AM15/
RLA File :09/24/040/00576/AM14/
Lic.No/Date:0910059289 14.02.2014

Decision : D/o Pharmaceuticals vide O.M.No.35011/332/2014-PI (Norms) dated

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December 2014 has informed that the matter has been examined and seen that export product and import item are chemically same. COA of the import item is not given from foreign supplies, it is felt that no manufacturing activity is involved which may account for 34.3% wastage.

Based on recommendation of Department of Pharmaceuticals, the committee has decided to reject the case.

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Case No.:374/5/82-ALC4/2015 Party Name:SURVIVAL

TECHNOLOGIES PVT.LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00514/AM16/
RLA File :03/95/040/01015/AM14/
Lic.No/Date:0310775114 20.03.2014 Defer Date 16.09.2015

the case for want of comments from D/o C&PC Chemicals.

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Case No.:95/5/82-ALC4/2015 Party Name:OTSUKA

CHEMICAL ( INDIA ) PRIVATE LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00235/AM16/
RLA File :05/24/040/00484/AM14/
Lic.No/Date:0510383070 28.03.2014

Decision : In the light of earlier decision taken in meeting no. 3/82 dated 08.05.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is lower: Item of Export Quantity S.No Item of Import Quantity Allowed kg/kg 7-Phenylacetamideo-3- Chloromethyl Cephalosporanic Acid Para Methoxybenzyl Ester (GCLE) While/Light Yellow Powder 1 kg 1. Penicillin G Potassium
1stCrystals 2.85 2. Methanol 2.00 3. Dimethyl Formamide 3.86 4. Methylene Chloride 2.09 5. 2-Mercaptobenzothiazole 0.511
6. Isopropyl Alcohol 1.25 RA may take appropriate action as per the decision of Norms Committee.

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Case No.:202/5/82-ALC4/2015 Party Name:HALDIA

PETROCHEMICALS LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00342/AM16/
RLA File :02/24/040/00007/AM15/
Lic.No/Date:0210202658 23.04.2014

Department of C&PC vide O.M.46011/54/2008-PC-II dt. 23.7.2015 as per details given below or as applied by the firm whichever is less:-
Export product Qty. Import item Qty.kg/kg Benzene (from Olefinic complex 1kg Naphtha 1.194

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Case No.:76/10/82-ALC4/2014 Party Name:KUDOS CHEMIE

LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00990/AM15/
RLA File :22/24/040/00099/AM14/
Lic.No/Date:2210014839 29.04.2014 Defer Date 02.09.2015 Decision : The committee in light of the written comment of D/o Pharmaceuticals forwarded vide O.M.No.35011/642/2014-PI(Norms) dated May 2015 decided to call for Past Production vis-à-vis Actual Consumption of all the imported inputs year wise for last 3 years duly certified by Central Excise Authorities from the firm and defer the case.

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Case No.:383/5/82-ALC4/2015 Party Name:DR REDDYS

LABORATORIES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00523/AM16/
RLA File :09/24/040/00019/AM15/
Lic.No/Date:0910060081 13.05.2014 Defer Date 02.09.2015: the case for want of comments from D/o C&PC Chemicals.

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Case No.:14/5/82-ALC4/2015 Party Name:YASHASHVI

RASAYAN PVT.LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00154/AM16/
RLA File :52/24/040/00009/AM15/
Lic.No/Date:5210041040 13.05.2014 Defer Date 16.09.2015 the case for want of comments from D/o C&PC Chemicals.

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

FINECHEM PVT. LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00155/AM16/
RLA File :08/24/040/00055/AM15/
Lic.No/Date:0810131405 19.05.2014 Defer Date 16.09.2015 Decision : The committee in light of the written comment of D/o C&PC forwarded vide O.M.No.14010/1/2012-CH-II dated July 2015 decided to call for following information from the firm:-

  1. Detailed manufacturing process with balanced chemical reactions indicating number of moles of all the reactants, products and by-products with corresponding molecular Formula structural formula molecular weight and process flow diagram.
  2. Stage wise percentage yield with respect of each of the reactant and products and the relevant justification enclosing therewith authentic printed technical literature in support of yield or quantity of items for import.
  3. Complete material balance indicating input and output material on weight to weight basis at each stage of manufacturing process.
  4. Details of byproducts formed during the process and the recovery of solvents in terms of quantity and value.
  5. Details of production of export product under reference and corresponding consumption of raw material in the year 2014-15, 2015-16 (April to June)

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  1. Any other relevant information, if any.

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Case No.:79/8/82-ALC4/2014 Party Name:BDR

PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00743/AM15/
RLA File :03/94/040/00040/AM15/
Lic.No/Date:0310782569 22.05.2014 Defer Date 30.09.2015 the case for want of comments from D/o C&PC Chemicals.

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Case No.:197/5/82-ALC4/2015 Party Name:SHASUN

PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Status: HQ File :01/82/050/00337/AM16/
RLA File :04/24/040/00048/AM15/
Lic.No/Date:0410158491 06.06.2014 Approved Department of Pharmaceuticals vide O.M.No35011/410/2014-PI (Norms) dt. January, 2015 as per details given below or as applied by the firm whichever is less:-
Export product Import item & Qty. Paroxetine Tablets PAROXETINE HYDROCHLORIDE -----------11.10mg/10mg tablets -----------22.20mg/20mg tablets -----------33.30mg/30mg tablets -----------44.40mg/40mg tablets

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Case No.:364/5/82-ALC4/2015 Party Name:AUROBINDO

PHARMA LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00504/AM16/
RLA File :09/24/040/00124/AM15/
Lic.No/Date:0910060469 17.06.2014 Defer Date 16.09.2015 the case for want of comments from D/o Pharmaceuticals.

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Case No.:394/5/82-ALC4/2015 Party Name:INDO HERBAL

EXTRACTIONS Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00534/AM16/
RLA File :22/24/040/00020/AM15/
Lic.No/Date:2210015010 08.07.2014

Department of Pharmaceuticals vide O.M.No35011/675/2013-PI (Norms) dt. 01.04.2014 as per Export product Qty. Import items Qty.kg/kg

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Yohimbine Hydrocloride USP 1kg Yohimbine bark with Yohimbine content not more than 1% 133.42

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Case No.:370/5/82-ALC4/2015 Party Name:HETERO LABS

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00510/AM16/
RLA File :09/24/040/00193/AM15/
Lic.No/Date:0910060634 09.07.2014 Defer Date 16.09.2015 the case for want of comments from D/o Pharmaceuticals.

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Case No.:375/5/82-ALC4/2015 Party Name:NECTAR

LIFESCIENCES LIMITED, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00515/AM16/
RLA File :22/24/040/00023/AM15/
Lic.No/Date:2210015018 12.07.2014 Defer Date 16.09.2015 Decision : : The Committee consider the case for ratification of norms and decided to defer the case for want of comments from D/o Pharmaceuticals.

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Case No.:365/5/82-ALC4/2015 Party Name:NECTAR

LIFESCIENCES LIMITED, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00505/AM16/
RLA File :22/24/040/00028/AM15/
Lic.No/Date:2210015020 15.07.2014 Defer Date 16.09.2015 the case for want of comments from D/o Pharmaceuticals.

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Case No.:94/5/82-ALC4/2015 Party Name:SHREE BANKEY

BEHARI LAL BOARD MILLS Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00234/AM16/
RLA File :05/24/040/00126/AM15/
Lic.No/Date:0510389737 16.07.2014 Defer Date 16.09.2015 the case for want of comments from D/o C&PC Chemicals.

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Case No.:354/5/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00494/AM16/
RLA File :09/24/040/00209/AM15/
Lic.No/Date:0910060668 17.07.2014

Department of C&PC vide U.O.No.14010/138/2011-CH-II dt. 7.7.2015 as per details given below or as applied by the firm whichever is less:-

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Export product Qty. Import items Qty.kg/kg Nitro Blue/Jarocol Blue - 12 1kg VIOLET 1,4 D OR JAROCOL VIOLET 1,4 D N,N-BIS(2-HYDROXYETHYL)-2- NITRO-P-PHEYLENEDIAMINE 1.70

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Case No.:396/5/82-ALC4/2015 Party Name:ESTEEM

INDUSTRIES PVT. LTD, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00536/AM16/
RLA File :17/24/040/00047/AM15/
Lic.No/Date:1710005887 24.07.2014 Defer Date 16.09.2015 the case for want of comments from D/o C&PC Chemicals.

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Case No.:93/5/82-ALC4/2015 Party Name:OTSUKA

CHEMICAL ( INDIA ) PRIVATE LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00233/AM16/
RLA File :05/24/040/00193/AM15/
Lic.No/Date:0510390052 01.08.2014

Decision : In the light of earlier decision taken in meeting no. 3/82 dated 08.05.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is lower: Item of Export Quantity S.No Item of Import Quantity Allowed kg/kg 7-Phenylacetamideo-3- Chloromethyl Cephalosporanic Acid Para Methoxybenzyl Ester (GCLE) While/Light Yellow Powder 1 kg 1. Penicillin G Potassium
1stCrystals 2.85 2. Methanol 2.00 3. Dimethyl Formamide 3.86 4. Methylene Chloride 2.09 5. 2-Mercaptobenzothiazole 0.511
6. Isopropyl Alcohol 1.25

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Case No.:373/5/82-ALC4/2015 Party Name:NECTAR

LIFESCIENCES LIMITED, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00513/AM16/
RLA File :22/24/040/00039/AM15/
Lic.No/Date:2210015055 06.08.2014 Defer Date 16.09.2015 the case for want of comments from D/o C&PC Pharmaceuticals.

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Case No.:203/5/82-ALC4/2015 Party Name:ALKALOIDS

CORPORATION Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00343/AM16/
RLA File :02/24/040/00080/AM15/
Lic.No/Date:0210204732 07.08.2014 Defer Date 16.09.2015

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Decision : : The Committee consider the case for ratification of norms and decided to defer the case for want of comments from D/o C&PC Pharmaceuticals.

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

PVT LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00188/AM16/
RLA File :09/24/040/00260/AM15/
Lic.No/Date:0910060860 18.08.2014 Defer Date 16.09.2015 Decision : : The Committee consider the case for ratification of norms and decided to defer the case for want of comments from D/o C&PC Pharmaceuticals.

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Case No.:378/5/82-ALC4/2015 Party Name:CATAPHARMA

CHEMICALS PVT. LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00518/AM16/
RLA File :31/83/040/00115/AM15/
Lic.No/Date:3110064753 19.08.2014 Defer Date 16.09.2015 Decision : : The Committee consider the case for ratification of norms and decided to defer the case for want of comments from D/o C&PC Pharmaceuticals.

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Case No.:397/5/82-ALC4/2015 Party Name:ALEMBIC

PHARMACEUTICALS LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00537/AM16/
RLA File :34/24/040/00128/AM15/
Lic.No/Date:3410040471 21.08.2014

Decision : Committee considered case as per agenda and in the light of earlier decision taken by NC in its meeting No.09/82 dated 20.10.2014 decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less:

Export Product IRBESARTAN HEUMANN 75 Mg, 150 Mg and 300 MG FILMTABLETTEN S.No Import item For 1 No. Tablet 75 mg
150 mg
300 mg 1. IRBESARTAN 75 mg 150 mg 300 mg 2. LACTOSE MONOHYDRATE ( GRANULAC- 200) 62.375 124.75 249.50 3 CROSCARMELLOSE SODIUM ( Ac Di Sol) 7.00 14.00 28.00 4. MAGNESIUM STEARATE 1.125 2.25 4.50

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Case No.:240/5/82-ALC4/2015 Party Name:VIC

INDUSTRIES, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00380/AM16/
RLA File :17/24/040/00054/AM15/
Lic.No/Date:1710005896 22.08.2014 Defer Date 16.09.2015 O.M.No.14010/70/2011-CH-II dated July 2015 decided to call for following information from the firm:-

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number of moles of all the reactants, products and by-products with corresponding molecular Formula structural formula molecular weight and process flow diagram. 3. Complete material balance indicating input and output material on weight to weight basis at each stage of manufacturing process. 4. Details of by products formed during the process and the recovery of solvents in 5. Details of production of export product under reference and corresponding 6. Any other relevant information, if any.

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Case No.:368/5/82-ALC4/2015 Party Name:MICRO LABS

LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00508/AM16/
RLA File :07/24/040/00108/AM15/
Lic.No/Date:0710106537 25.08.2014 Defer Date 16.09.2015 Decision : : The Committee consider the case for ratification of norms and decided to defer the case for want of comments from D/o C&PC Pharmaceuticals.

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Case No.:382/5/82-ALC4/2015 Party Name:ALEMBIC

PHARMACEUTICALS LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00522/AM16/
RLA File :34/24/040/00129/AM15/
Lic.No/Date:3410040491 27.08.2014 Defer Date 16.09.2015 Decision : : The Committee consider the case for ratification of norms and decided to defer the case for want of comments from D/o C&PC Pharmaceuticals.

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Case No.:377/5/82-ALC4/2015 Party Name:ENCUBE

ETHICALS PVT LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00517/AM16/
RLA File :03/94/040/00493/AM15/
Lic.No/Date:0310788472 27.08.2014 Defer Date 16.09.2015 Decision : : The Committee consider the case for ratification of norms and decided to defer the case for want of comments from D/o C&PC Pharmaceuticals.

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Case No.:389/5/82-ALC4/2015 Party Name:SHIVA

PHARMACHEM LTD, Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00529/AM16/
RLA File :34/24/040/00131/AM15/
Lic.No/Date:3410040489 27.08.2014

Decision : Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/164/2011/Ch II dated 12.12.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Export Product Export Quantity S.No Import Product Quantity Allowed

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3,5-Dimethylbenzoyl Chloride (DMBC) Assay Min 99% 1 kg 1. Mesitylene / 1,3,5- Trimethyl Benzene. Assay Min 99% 1.128 kg

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Case No.:456/5/82-ALC4/2015 Party Name:CLARION DRUGS

LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00596/AM16/
RLA File :50/24/040/00006/AM15/
Lic.No/Date:5010002152 28.08.2014 Defer Date 16.09.2015 Decision : The Committee consider the case for ratification of norms under para 4.07 of HBP vol1. and decided to defer the case for want of comments from D/o C&PC Pharmaceuticals.

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Case No.:379/5/82-ALC4/2015 Party Name:PRECISE

CHEMIPHARMA PVT.LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00519/AM16/
RLA File :31/83/040/00135/AM15/
Lic.No/Date:3110064830 03.09.2014

Decision : In the light of earlier decision taken in meeting no. 02/82/15 dated 29.04.2015, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Export product Export Qty. Sl.No. Import items Qty. allowed Orlistat Pellets 50% 1 kg 1. Orlistat 0.505/kg RA may take appropriate action as per the decision of Norms committee

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Case No.:401/5/82-ALC4/2015 Party Name:ONEIRO

CHEMICALS LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00541/AM16/
RLA File :34/24/040/00141/AM15/
Lic.No/Date:3410040510 04.09.2014 Defer Date 16.09.2015 Pharmaceuticals.

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Case No.:81/5/82-ALC4/2015 Party Name:RUCHI

INFRASTRUCTURE LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00221/AM16/
RLA File :56/24/040/00034/AM15/
Lic.No/Date:5610004407 15.09.2014 Defer Date 16.09.2015 Decision : The Committee in light of written comments of D/o C&PC letter No.14010/31/2015-CH-II dated 15.7.2015 decided to call for following information from the firm:-

  1. Specific chemical name and technical specifications of Bio Diesel to be exported

12

along with copy of export order. 2. Detailed manufacturing process with balanced chemical reactions indicating number of moles of all the reactants, products and by products with corresponding molecular formulae, structural formulae, molecular weight and process flow diagram. 3. Stage wise percentage yield with respect of each of the reactants and products and 4. Details of by product formed during the process and their recovery in terms of quantity and value. 5. Details of production of export product under reference from your supporting manufacturer and corresponding consumption of raw materials in the year 2013-14 and 2014-15 duly certified by CA may be furnished, if the production has not commenced in the past, the details from commencement of production ;may be furnished duly certified by CA. 6. Any other relevant information, if any.

42

Case No.:391/5/82-ALC4/2015 Party Name:TIDE

INDUSTRIES Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00531/AM16/
RLA File :34/24/040/00138/AM15/
Lic.No/Date:3410040551 15.09.2014 Defer Date 16.09.2015 O.M.No.14010/40/2011-CH-II dated 28 July 2015 decided to call for following information from the firm:- number of moles of all the reactants, products and by-products with corresponding molecular Formula structural formula molecular weight and process flow diagram. 3. Complete material balance indicating input and output material on weight to weight basis at each stage of manufacturing process. 4. Details of by products formed during the process and the recovery of solvents in 5. Details of production of export product under reference and corresponding 6. Any other relevant information, if any.

43

Case No.:398/5/82-ALC4/2015 Party Name:YASH RASAYAN

& CHEMICALS Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00538/AM16/
RLA File :34/24/040/00122/AM15/
Lic.No/Date:3410040555 15.09.2014 Defer Date 16.09.2015 O.M.No.14010/70/2011-CH-II dated July 2015 decided to call for following information from the firm:- number of moles of all the reactants, products and by-products with corresponding

13

molecular Formula structural formula molecular weight and process flow diagram. 3. Complete material balance indicating input and output material on weight to weight basis at each stage of manufacturing process. 4. Details of by products formed during the process and the recovery of solvents in 5. Details of production of export product under reference and corresponding 6. Any other relevant information, if any.

44

Case No.:400/5/82-ALC4/2015 Party Name:YASH RASAYAN

& CHEMICALS Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00540/AM16/
RLA File :34/24/040/00120/AM15/
Lic.No/Date:3410040554 15.09.2014 Defer Date 16.09.2015 Chemicals.

45

Case No.:380/5/82-ALC4/2015 Party Name:THEON

PHARMACEUTICALS LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00520/AM16/
RLA File :22/24/040/00054/AM15/
Lic.No/Date:2210015086 16.09.2014 Defer Date 16.09.2015 Pharmaceuticals.

46

Case No.:399/5/82-ALC4/2015 Party Name:ALCHEM

INTERNATIONAL LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00539/AM16/
RLA File :05/23/040/00235/AM15/
Lic.No/Date:0510391191 18.09.2014 Defer Date 16.09.2015 Decision :The Committee in light of written comments of D/o Pharmaceuticals O.M. No.35011/168/2014-PI (Norms) September, 2014 decided to call for following a) Actual content of digoxin in imported digitalis lanata Leares supported by COA from foreign supplier. b) Assay of export product. c) Past production vis-à-vis actual consumption of Leaves for the last 3 years duly certified by Central Excise Authorities.

47

Case No.:381/5/82-ALC4/2015 Party Name:ASCENT

FINECHEM PVT. LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00521/AM16/
RLA File :08/24/040/00207/AM15/
Lic.No/Date:0810133388 19.09.2014 Defer Date 16.09.2015

14

Pharmaceuticals.

48

Case No.:390/5/82-ALC4/2015 Party Name:ATUL LIMITED,

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00530/AM16/
RLA File :08/24/040/00225/AM15/
Lic.No/Date:0810133394 19.09.2014 Defer Date 16.09.2015 Pharmaceuticals.

49

Case No.:376/5/82-ALC4/2015 Party Name:R.K.INDUSTRIES, Meet No/Date:5/82-

ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00516/AM16/
RLA File :08/24/040/00231/AM15/
Lic.No/Date:0810133412 23.09.2014 Defer Date 16.09.2015 Chemicals.

50

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

PVT LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00189/AM16/
RLA File :09/24/040/00336/AM15/
Lic.No/Date:0910061013 23.09.2014 Defer Date 16.09.2015 Pharmaceuticals.

51

Case No.:176/13/82-

ALC4/2014
Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Status:Deffered and Re-indexed HQ File :01/82/050/01179/AM15/
RLA File :03/94/040/00361/AM15/
Lic.No/Date:0310789985 07.10.2014 Defer Date 16.09.2015 Pharmaceuticals.

52

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

PHARMACHEM (INDIA)(PROP.ADITYA PRAMOD JOGDEO) Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00512/AM16/
RLA File :31/83/040/00154/AM15/
Lic.No/Date:3110064948 08.10.2014 Defer Date 16.09.2015

15

HBP vol1. and decided to call for COA of import and export product as import and export items are same.

53

Case No.:356/5/82-ALC4/2015 Party Name:GLAND PHARMA

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00496/AM16/
RLA File :09/24/040/00350/AM15/
Lic.No/Date:0910061069 09.10.2014 Defer Date 16.09.2015 Pharmaceuticals.

54

Case No.:350/5/82-ALC4/2015 Party Name:AMBE

PHYTOEXTRACTS PVT.LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00490/AM16/
RLA File :05/23/040/00238/AM15/
Lic.No/Date:0510391555 13.10.2014 Defer Date 16.09.2015 Chemicals

55

Case No.:124/5/82-ALC4/2015 Party Name:DORF-KETAL

CHEMICALS INDIA PVT.LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00264/AM16/
RLA File :03/94/040/00684/AM15/
Lic.No/Date:0310790248 14.10.2014 Defer Date 16.09.2015 Chemicals.

56

Case No.:369/5/82-ALC4/2015 Party Name:GLAND PHARMA

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00509/AM16/
RLA File :09/24/040/00344/AM15/
Lic.No/Date:0910061096 15.10.2014 Defer Date 16.09.2015 Pharmaceuticals.

57

Case No.:384/5/82-ALC4/2015 Party Name:SATYADEVA

PHARMACEUTICALS /P/ LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00524/AM16/
RLA File :09/24/040/00382/AM15/
Lic.No/Date:0910061123 20.10.2014 Defer Date 16.09.2015 Pharmaceuticals.

16

58

Case No.:125/5/82-ALC4/2015 Party Name:DORF-KETAL

CHEMICALS INDIA PVT.LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00265/AM16/
RLA File :03/94/040/00605/AM15/
Lic.No/Date:0310790441 21.10.2014 Defer Date 16.09.2015 Chemicals.

59

Case No.:352/5/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00492/AM16/
RLA File :09/24/040/00398/AM15/
Lic.No/Date:0910061128 22.10.2014 Defer Date 16.09.2015 Chemicals.

60

Case No.:387/5/82-ALC4/2015 Party Name:SUVEN LIFE

SCIENCES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00527/AM16/
RLA File :09/24/040/00412/AM15/
Lic.No/Date:0910061152 29.10.2014 Defer Date 16.09.2015 Pharmaceuticals.

61

Case No.:388/5/82-ALC4/2015 Party Name:MYLAN

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00528/AM16/
RLA File :09/24/040/00396/AM15/
Lic.No/Date:0910061183 05.11.2014 Defer Date 16.09.2015 Pharmaceuticals.

62

Case No.:386/5/82-ALC4/2015 Party Name:SRINI

PHARMACEUTICALS LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00526/AM16/
RLA File :09/24/040/00416/AM15/
Lic.No/Date:0910061191 07.11.2014 Defer Date 16.09.2015 Pharmaceuticals.

63

Case No.:359/5/82-ALC4/2015 Party Name:NECTAR

LIFESCIENCES LIMITED, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred

17

HQ File :01/82/050/00499/AM16/
RLA File :22/24/040/00067/AM15/
Lic.No/Date:2210015119 10.11.2014 Defer Date 16.09.2015 Pharmaceuticals.

64

Case No.:358/5/82-ALC4/2015 Party Name:SHEETAL

CHEMICALS PVT LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00498/AM16/
RLA File :09/24/040/00422/AM15/
Lic.No/Date:0910061196 10.11.2014 Defer Date 16.09.2015 Chemicals

65

Case No.:393/5/82-ALC4/2015 Party Name:MYLAN

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00533/AM16/
RLA File :09/24/040/00387/AM15/
Lic.No/Date:0910061210 11.11.2014 Defer Date 16.09.2015 Pharmaceuticals.

66

Case No.:198/5/82-ALC4/2015 Party Name:SHASUN

PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00338/AM16/
RLA File :04/24/040/00205/AM15/
Lic.No/Date:0410159704 11.11.2014 Defer Date 16.09.2015 Pharmaceuticals.

67

Case No.:351/5/82-ALC4/2015 Party Name:RAY

CHEMICALS PRIVATE LIMITED, Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00491/AM16/
RLA File :07/24/040/00286/AM15/
Lic.No/Date:0710106968 13.11.2014

Department of Pharmaceuticals vide O.M.No35011/551/2013-PI (Norms) dt21.11.2013 as per Export product Qty. Import items Qty.kg/kg Doxepin Hcl 1kg 1-Bromo 3 chlorom propane 1.12 Tetra hydro furan 0.68 Magnesium ingot 0.19

18

68

Case No.:392/5/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00532/AM16/
RLA File :09/24/040/00405/AM15/
Lic.No/Date:0910061222 13.11.2014 Defer Date 16.09.2015 Chemicals.

69

Case No.:196/5/82-

ALC4/2015
Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00336/AM16/
RLA File :04/24/040/00211/AM15/
Lic.No/Date:0410159749 17.11.2014 Defer Date
Decision : In the light of earlier decision taken in the meeting no. 14/28/2014 dated 22.12.2014, it was decided to ratify norms under Para 4.07 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed PAROXETINE TABLETS 10 MG 1 million tablet 1. PAROXETINE HYDROCHLORIDE 11.10 mg/10 mg Tablet RA concerned may take further necessary action as per above decision of NC

70

Case No.:129/5/82-ALC4/2015 Party Name:INDOCO

REMEDIES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00269/AM16/
RLA File :03/94/040/00740/AM15/
Lic.No/Date:0310791183 18.11.2014 Defer Date 16.09.2015 Pharmaceuticals.

71

Case No.:366/5/82-ALC4/2015 Party Name:MYLAN

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00506/AM16/
RLA File :09/24/040/00424/AM15/
Lic.No/Date:0910061281 20.11.2014 Defer Date 16.09.2015 Pharmaceuticals.

72

Case No.:371/5/82-ALC4/2015 Party Name:MYLAN

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00511/AM16/
RLA File :09/24/040/00463/AM15/
Lic.No/Date:0910061295 24.11.2014 Defer Date 16.09.2015

19

Pharmaceuticals.

73

Case No.:357/5/82-ALC4/2015 Party Name:AUROBINDO

PHARMA LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00497/AM16/
RLA File :09/24/040/00435/AM15/
Lic.No/Date:0910061305 25.11.2014 Defer Date 16.09.2015 Pharmaceuticals.

74

Case No.:355/5/82-ALC4/2015 Party Name:GRANULES

INDIA LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00495/AM16/
RLA File :09/24/040/00433/AM15/
Lic.No/Date:0910061297 25.11.2014 Defer Date 16.09.2015 Pharmaceuticals.

75

Case No.:367/5/82-ALC4/2015 Party Name:MYLAN

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00507/AM16/
RLA File :09/24/040/00476/AM15/
Lic.No/Date:0910061308 25.11.2014 Defer Date 16.09.2015 Pharmaceuticals.

76

Case No.:126/5/82-ALC4/2015 Party Name:IND-SWIFT

LABORATORIES LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00266/AM16/
RLA File :22/24/040/00074/AM15/
Lic.No/Date:2210015136 28.11.2014 Defer Date 16.09.2015 Pharmaceuticals.

77

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

PLASTICIZERS LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00502/AM16/
RLA File :05/23/040/00377/AM15/
Lic.No/Date:0510392211 28.11.2014 Defer Date 16.09.2015 Chemicals.

20

78

Case No.:395/5/82-ALC4/2015 Party Name:KRISHNA

ANTIOXIDANTS PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00535/AM16/
RLA File :03/94/040/00820/AM15/
Lic.No/Date:0310791544 28.11.2014

Department of C&PC U.O.No.14010/100/2012-CH-II dt. 15.4.2015 as per details given below or as applied by the firm whichever is less:-
Export product Qty. Import items Qty.kg/kg Triphenyl Phosphite 1kg Phenol 0.937 Yellow Phosphorus 0.100

79

Case No.:247/5/82-ALC4/2015 Party Name:SHREEGEN

PHARMA LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00387/AM16/
RLA File :09/24/040/00467/AM15/
Lic.No/Date:0910061323 28.11.2014 Defer Date 16.09.2015 Pharmaceuticals.

80

Case No.:257/5/82-ALC4/2015 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00397/AM16/
RLA File :03/95/040/00706/AM15/
Lic.No/Date:0310791534 28.11.2014 Defer Date 16.09.2015 Chemicals.

81

Case No.:360/5/82-ALC4/2015 Party Name:DHANUKA

LABORATORIES LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00500/AM16/
RLA File :05/23/040/00386/AM15/
Lic.No/Date:0510392229 01.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

82

Case No.:361/5/82-ALC4/2015 Party Name:DHANUKA

LABORATORIES LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00501/AM16/
RLA File :05/23/040/00380/AM15/
Lic.No/Date:0510392228 01.12.2014 Defer Date 16.09.2015

21

Pharmaceuticals.

83

Case No.:363/5/82-ALC4/2015 Party Name:DHANUKA

LABORATORIES LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00503/AM16/
RLA File :05/23/040/00385/AM15/
Lic.No/Date:0510392246 02.12.2014

Department of Pharmaceuticals vide O.M.No35011/425/2014-PI (Norms) dt. February, 2014 as Export product Qty. Import items Qty.kg/kg Cefpodoxime Proxetil USP/BP/ IP/JP/EP POWDER 1kg 1 7 Amino Cephalosporanic Acid ( 7-ACA ) 0.956 2
MAEM (2- Mercaptobenzothiazolyl (z)-2- (2-Aminothaizole-4-yl)-2- Methoxyimino Acetate 0.956 3 TRIETHYLAMINE 0.47 4 1 Chloro ethyl Isopropyl Carbonate 0.55 5 Acetone 2.475 6 Methylene Chloride 3.541 7 N,N-dimethyl Acetamide 2.02 8
METHANOL 1.481 9 1,8 Diazabicylo(5.4.0) under 7-ENE 0.319

84

Case No.:245/5/82-ALC4/2015 Party Name:GLAND PHARMA

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00385/AM16/
RLA File :09/24/040/00470/AM15/
Lic.No/Date:0910061327 02.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

85

Case No.:264/5/82-ALC4/2015 Party Name:GLAND PHARMA

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00404/AM16/
RLA File :09/24/040/00471/AM15/
Lic.No/Date:0910061328 02.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

22

86

Case No.:128/5/82-ALC4/2015 Party Name:STERLING

AUXILIARIES PVT LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00268/AM16/
RLA File :03/95/040/00733/AM15/
Lic.No/Date:0310791625 02.12.2014 Defer Date 16.09.2015 Chemicals.

87

Case No.:68/18/82-

ALC4/2014
Party Name:CROWN CHEMICALS PVT.LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Status:Deffered and Re-indexed HQ File :01/82/050/01434/AM15/
RLA File :03/94/040/00838/AM15/
Lic.No/Date:0310791657 03.12.2014 Defer Date 16.09.201525.06.2015 Chemicals.

88

Case No.:50/5/82-ALC4/2015 Party Name:RAJ PIONEER

LABORATORIES INDIA PRIVATE LIMITED, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00190/AM16/
RLA File :56/24/040/00040/AM15/
Lic.No/Date:5610004489 03.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

89

Case No.:261/5/82-ALC4/2015 Party Name:SMILAX

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00401/AM16/
RLA File :09/24/040/00493/AM15/
Lic.No/Date:0910061345 04.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

90

Case No.:207/5/82-ALC4/2015 Party Name:SRINI

PHARMACEUTICALS LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00347/AM16/
RLA File :09/24/040/00474/AM15/
Lic.No/Date:0910061343 04.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

91

Case No.:385/5/82-ALC4/2015 Party Name:AMI ORGANICS

PVT LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred

23

HQ File :01/82/050/00525/AM16/
RLA File :52/24/040/00044/AM15/
Lic.No/Date:5210041339 05.12.2014 Defer Date 16.09.2015 Chemicals.

92

Case No.:154/5/82-ALC4/2015 Party Name:SHALINA

LABORATORIES PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00294/AM16/
RLA File :03/95/040/00740/AM15/
Lic.No/Date:0310791735 05.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

93

Case No.:265/5/82-ALC4/2015 Party Name:SUVEN LIFE

SCIENCES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00405/AM16/
RLA File :09/24/040/00479/AM15/
Lic.No/Date:0910061351 05.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

94

Case No.:244/5/82-ALC4/2015 Party Name:VIVIN

LABORATORIES PRIVATE LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00384/AM16/
RLA File :09/24/040/00420/AM15/
Lic.No/Date:0910061353 05.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

95

Case No.:248/5/82-ALC4/2015 Party Name:VIVIN

LABORATORIES PRIVATE LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00388/AM16/
RLA File :09/24/040/00483/AM15/
Lic.No/Date:0910061354 05.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

96

Case No.:258/5/82-ALC4/2015 Party Name:HETERO DRUGS

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00398/AM16/
RLA File :09/24/040/00497/AM15/
Lic.No/Date:0910061363 09.12.2014

24

Department of Pharmaceuticals vide O.M.No35011/580/2015-PI (Norms) dt. May 2015 as per Export product Qty. Import items Qty.kg/kg Lisinopril 1kg 2,2,2-Trifluoro acetic acid 1.26 L-Lysine monohydrochloride 1.545 3-Benzoyl acrylic acid ethyl ester 0.85 Lithium hydroxide 0.184 L-Proline 0.84 N,N-Carbonyl diimidazole 0.400 Methylene Chloride 3.43 Acetone 7.00

97

Case No.:146/5/82-ALC4/2015 Party Name:IPCA

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00286/AM16/
RLA File :03/94/040/00852/AM15/
Lic.No/Date:0310791848 09.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

98

Case No.:140/5/82-ALC4/2015 Party Name:ALKYL AMINES

CHEMICALS LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00280/AM16/
RLA File :03/94/040/00709/AM15/
Lic.No/Date:0310791867 10.12.2014

Department of C&PC U.O.No.14010/85/2012-CH-II dt. 18.6.2015 as per details given below or as applied by the firm whichever is less:-
Export product Qty. Import items Qty.kg/kg 2-Ethyl Hexyl amine 1kg 2-Ethyl Hexanol 1.011

99

Case No.:139/5/82-ALC4/2015 Party Name:J.B. CHEMICALS

& PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00279/AM16/
RLA File :03/94/040/00872/AM15/
Lic.No/Date:0310791890 10.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

25

100

Case No.:153/5/82-ALC4/2015 Party Name:ALEMBIC

PHARMACEUTICALS LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00293/AM16/
RLA File :34/24/040/00244/AM15/
Lic.No/Date:3410040785 12.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

101

Case No.:101/5/82-ALC4/2015 Party Name:IPCA

Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00241/AM16/
RLA File :03/94/040/00851/AM15/
Lic.No/Date:0310791942 12.12.2014

Decision : In the light of earlier decision taken by NC in its meeting No.18/82/2014dated 18.02.2015 , it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Item of Export Qty. Sl.No. Item of Import Quantity allowed kg/kg Etodolac 1 kg 1. 7-Ethyl Tryptophol

0.72 2. Methyl-3-Oxopentonoate

0.54 3. Methanol

1.14

102

Case No.:260/5/82-ALC4/2015 Party Name:MYLAN

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00400/AM16/
RLA File :09/24/040/00488/AM15/
Lic.No/Date:0910061381 12.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

103

Case No.:172/5/82-ALC4/2015 Party Name:RA CHEM

PHARMA LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00312/AM16/
RLA File :09/24/040/00514/AM15/
Lic.No/Date:0910061384 12.12.2014

Department of Pharmaceuticals vide O.M.No35011/109/2013-PI (Norms) dt. 29.04.2013 as per Export product Qty. Import items Qty.kg/kg

26

Efavirenz

(s)-5-Chloro-Alpha-(Cyclopropylethnyl)- 2-Amino-Alpha(Trifluoromethyl)Benzene Methanol 0.987 Triphosgene 0.431

104

Case No.:206/5/82-ALC4/2015 Party Name:SUVEN LIFE

SCIENCES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00346/AM16/
RLA File :09/24/040/00511/AM15/
Lic.No/Date:0910061382 12.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

105

Case No.:263/5/82-ALC4/2015 Party Name:SUVEN LIFE

SCIENCES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00403/AM16/
RLA File :09/24/040/00512/AM15/
Lic.No/Date:0910061383 12.12.2014

Department of Pharmaceuticals vide O.M.No35011/285/2014-PI (Norms) dt. October, 2014 as Export product Qty. Import items Qty.kg/kg Gabapentin 1kg 1,1 CYCLOHEXANE DIACETIC ACID MONOAMIDE
1.63 ACETONE 1.541

106

Case No.:246/5/82-ALC4/2015 Party Name:RAKSHIT DRUGS

PVT LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00386/AM16/
RLA File :09/24/040/00426/AM15/
Lic.No/Date:0910061387 15.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

107

Case No.:145/5/82-ALC4/2015 Party Name:JINDAL DRUGS

PRIVATE LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00285/AM16/
RLA File :03/94/040/00877/AM15/
Lic.No/Date:0310792112 17.12.2014 Defer Date 16.09.2015

27

Chemicals.

108

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

FLUORINE INTERNATIONAL LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00270/AM16/
RLA File :03/95/040/00652/AM15/
Lic.No/Date:0310792103 17.12.2014 Defer Date 16.09.2015 Chemicals.

109

Case No.:127/5/82-ALC4/2015 Party Name:EMAMI

LIMITED, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00267/AM16/
RLA File :02/24/040/00183/AM15/
Lic.No/Date:0210205355 18.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

110

Case No.:217/5/82-ALC4/2015 Party Name:LEE PHARMA

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00357/AM16/
RLA File :09/24/040/00513/AM15/
Lic.No/Date:0910061406 18.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

111

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

INDUSTRIES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00273/AM16/
RLA File :03/94/040/00883/AM15/
Lic.No/Date:0310792178 19.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

112

Case No.:98/5/82-ALC4/2015 Party Name:BLUE CIRCLE

ORGANICS PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00238/AM16/
RLA File :03/94/040/00790/AM15/
Lic.No/Date:0310792183 19.12.2014

Department of Pharmaceuticals vide O.M.No35011/413/2012-PI (Norms) dt. September, 2012 as per details given below or as applied by the firm whichever is less:-
Export product Qty. Import items Qty.kg/kg

28

5-NITRO ISOPHTHALIC ACID DIMETHYL ETSER 1kg Isophthalic Acid 0.90

113

Case No.:99/5/82-ALC4/2015 Party Name:FDC LTD

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00239/AM16/
RLA File :03/94/040/00674/AM15/
Lic.No/Date:0310792173 19.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

114

Case No.:100/5/82-ALC4/2015 Party Name:FDC LTD

Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00240/AM16/
RLA File :03/94/040/00599/AM15/
Lic.No/Date:0310792174 19.12.2014

Decision : In the light of earlier decision taken in meeting no. 13/82/14 dated 19.12.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Export Product Export Qty. Sl.No. import items Qty. allowed Chloramphenicol Eye Drops 0.5% w/v 10 ml Vial made out of LDPE 1 No. 1. Chloramphenicol 0.05 gram

115

Case No.:143/5/82-ALC4/2015 Party Name:FDC LTD

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00283/AM16/
RLA File :03/94/040/00834/AM15/
Lic.No/Date:0310792175 19.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

116

Case No.:97/5/82-ALC4/2015 Party Name:INDOFIL

INDUSTRIES LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00237/AM16/
RLA File :03/94/040/00896/AM15/
Lic.No/Date:0310792172 19.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

29

117

Case No.:205/5/82-ALC4/2015 Party Name:SALICYLATES &

CHEMICALS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00345/AM16/
RLA File :09/24/040/00517/AM15/
Lic.No/Date:0910061414 19.12.2014 Defer Date 16.09.2015 O.M.No.14010/34/2011-CH-II dated 31st July 2015 decided to call for following number of moles of all the reactants, products and by-products with corresponding molecular Formula structural formula molecular weight and process flow diagram. 3. Complete material balance indicating input and output material on weight to weight basis at each stage of manufacturing process. 4. Details of by products formed during the process and the recovery of solvents in 5. Any other relevant information, if any.

118

Case No.:123/5/82-ALC4/2015 Party Name:CADILA

HEALTHCARE LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00263/AM16/
RLA File :08/24/040/00347/AM15/
Lic.No/Date:0810134112 22.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

119

Case No.:144/5/82-ALC4/2015 Party Name:INDOCO

REMEDIES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00284/AM16/
RLA File :03/94/040/00892/AM15/
Lic.No/Date:0310792262 22.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

120

Case No.:256/5/82-ALC4/2015 Party Name:PERKIN

LABORATORIES Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00396/AM16/
RLA File :09/24/040/00520/AM15/
Lic.No/Date:0910061418 22.12.2014

Department of Pharmaceuticals vide O.M.No35011/561/2015-PI (Norms) dt. April 2015 as per

30

Export product Qty. Import items Qty.kg/kg Bromo Ketorolac (or) 5-Benzoyl, 3bromo-2,3- Dihydro, 1-H pyrrolizine-1- carboxylic acid 1kg 1 Pyrrole 0.79 2 Isopropenyl Acetate 0.90 3 Dimethyl Sulphoxide 1.71 4 DMF 1.53 5 Potassium Carbonate 4.16 6 Di-ethyl malonate 2.29

121

Case No.:224/5/82-ALC4/2015 Party Name:SUVEN LIFE

SCIENCES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00364/AM16/
RLA File :09/24/040/00531/AM15/
Lic.No/Date:0910061427 22.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

122

Case No.:262/5/82-ALC4/2015 Party Name:VARAHI

PHARMA PRIVATE LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00402/AM16/
RLA File :09/24/040/00481/AM15/
Lic.No/Date:0910061416 22.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

123

Case No.:216/5/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00356/AM16/
RLA File :09/24/040/00538/AM15/
Lic.No/Date:0910061424 22.12.2014 Defer Date 16.09.2015 Chemicals.

124

Case No.:136/5/82-ALC4/2015 Party Name:AVIGNON EXIM

PVT.LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00276/AM16/
RLA File :03/94/040/00843/AM15/
Lic.No/Date:0310792314 23.12.2014 Defer Date 16.09.2015 Chemicals.

31

125

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

& PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00236/AM16/
RLA File :03/94/040/00912/AM15/
Lic.No/Date:0310792310 23.12.2014 Defer Date 16.09.2015 Chemicals.

126

Case No.:221/5/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00361/AM16/
RLA File :09/24/040/00537/AM15/
Lic.No/Date:0910061442 23.12.2014 Defer Date 16.09.2015 Chemicals.

127

Case No.:329/5/82-ALC4/2015 Party Name:CAMPHOR &

ALLIED PRODUCTS LIMITED, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00469/AM16/
RLA File :03/94/040/00899/AM15/
Lic.No/Date:0310792365 24.12.2014 Defer Date 16.09.2015 Chemicals.

128

Case No.:135/5/82-ALC4/2015 Party Name:IPCA

Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00275/AM16/
RLA File :03/94/040/00818/AM15/
Lic.No/Date:0310792344 24.12.2014

Department of Pharmaceuticals vide O.M.No35011/338/2014-PI (Norms) dt. January, 2015 as Export product Import items Qty.kg/kg A. Allopurinol -306 mg tablet B. Allopurinol -300mg tablet 3-Amino Pyrazole Carboxamide Hemisulphate 1.5380 Formamide 1.50

129

Case No.:114/5/82-ALC4/2015 Party Name:NATIONAL

TUBE INDUSTRIES, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00254/AM16/
RLA File :03/95/040/00756/AM15/
Lic.No/Date:0310792363 24.12.2014 Defer Date 16.09.2015

32

Pretrochemicals.

13 0

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

INDUSTRIES PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00222/AM16/
RLA File :34/24/040/00249/AM15/
Lic.No/Date:3410040837 24.12.2014

Decision : : In the light of the earlier decision taken by NC in its meeting No.08/82/2014 dated 25.09.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Sl. No. Export product Exp. Qty. Import items Qty. Allowed 1 CALCIUM OROTATE 1 kg OROTIC ACID
1.059

131

Case No.:113/5/82-ALC4/2015 Party Name:VEXTA

LABORATORIES PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00253/AM16/
RLA File :03/95/040/00792/AM15/
Lic.No/Date:0310792352 24.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

132

Case No.:236/5/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00376/AM16/
RLA File :09/24/040/00527/AM15/
Lic.No/Date:0910061446 24.12.2014

Department of Pharmaceuticals vide O.M.No35011/23/2015-PI (Norms) dt. 16.6.2015 as per Export product Qty. Import items Qty.kg/kg SODIUM ASCORBYL PHOSPHATE OR C- VITE 1kg L-ASCORBATE 2-PHOSPHATE 35% OR CALCIUM ASCORBYL PHOSPHATE 1.940 ION EXCHANGE RESIN SUQING 001X8 H OR RESINE 4.00 METHANOL 3.00

133 Case No.:108/5/82-ALC4/2015 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:5/82- ALC4/2015 Deferred

33

25.06.2015 HQ File :01/82/050/00248/AM16/
RLA File :03/94/040/00908/AM15/
Lic.No/Date:0310792384 26.12.2014 Defer Date 16.09.2015 Chemicals.

134

Case No.:115/5/82-ALC4/2015 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00255/AM16/
RLA File :03/95/040/00816/AM15/
Lic.No/Date:0310792387 26.12.2014 Defer Date 16.09.2015 Chemicals.

135

Case No.:271/5/82-ALC4/2015 Party Name:AARTI

INDUSTRIES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00411/AM16/
RLA File :03/94/040/00882/AM15/
Lic.No/Date:0310792412 29.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

136

Case No.:241/5/82-ALC4/2015 Party Name:ASTRIX

LABORATORIES LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00381/AM16/
RLA File :09/24/040/00516/AM15/
Lic.No/Date:0910061461 29.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

137

Case No.:90/5/82-ALC4/2015 Party Name:BEST VALUE

CHEM PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00230/AM16/
RLA File :34/24/040/00254/AM15/
Lic.No/Date:3410040841 29.12.2014 Defer Date 16.09.2015 Chemicals.

138

Case No.:215/5/82-ALC4/2015 Party Name:EYTAN LABS

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00355/AM16/
RLA File :09/24/040/00530/AM15/
Lic.No/Date:0910061459 29.12.2014 Defer Date 16.09.2015

34

Pharmaceuticals.

139

Case No.:218/5/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00358/AM16/
RLA File :09/24/040/00552/AM15/
Lic.No/Date:0910061462 29.12.2014 Defer Date 16.09.2015 Chemicals.

140

Case No.:120/5/82-ALC4/2015 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00260/AM16/
RLA File :03/95/040/00820/AM15/
Lic.No/Date:0310792428 29.12.2014 Defer Date 16.09.2015 Chemicals.

141

Case No.:142/5/82-ALC4/2015 Party Name:FDC LTD

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00282/AM16/
RLA File :03/94/040/00923/AM15/
Lic.No/Date:0310792455 30.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

142

Case No.:65/5/82-ALC4/2015 Party Name:CLEAN SCIENCE

AND TECHNOLOGY PVT.LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00205/AM16/
RLA File :31/83/040/00204/AM15/
Lic.No/Date:3110065167 31.12.2014 Defer Date 16.09.2015 O.M.No.14010/3/2012-CH-II dated 31st July 2015 decided to call for following 3. Details of by products formed during the process and the recovery of solvents in

35

  1. Details of production of export product under reference and corresponding

143

Case No.:91/5/82-ALC4/2015 Party Name:EMCURE

PHARMACEUTICALS LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00231/AM16/
RLA File :31/83/040/00172/AM15/
Lic.No/Date:3110065164 31.12.2014

Department of Pharmaceuticals vide O.M.No35011/493/2014-PI (Norms) dt. March, 2015 as per Export product Qty. Import items Qty.kg/kg DEXKETOPROFEN TROMETAMOL 1kg 3(1-CYANOETHYL) BENZOPHENONE 1.82 N-OCTYL-D-GLUCAMINE 0.36

144

Case No.:222/5/82-ALC4/2015 Party Name:SATYA

DEEPTHA PHARMACEUTICALS LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00362/AM16/
RLA File :09/24/040/00553/AM15/
Lic.No/Date:0910061469 31.12.2014 Defer Date 16.09.2015 Pharmaceuticals.

145

Case No.:134/5/82-ALC4/2015 Party Name:BDR

PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00274/AM16/
RLA File :03/94/040/00712/AM15/
Lic.No/Date:0310792545 01.01.2015 Defer Date 16.09.2015 Pharmaceuticals

146

Case No.:226/5/82-ALC4/2015 Party Name:EYTAN LABS

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00366/AM16/
RLA File :09/24/040/00554/AM15/
Lic.No/Date:0910061471 01.01.2015 Defer Date 16.09.2015 Pharmaceuticals

147 Case No.:137/5/82-ALC4/2015 Party Name:J.B. CHEMICALS Meet No/Date:5/82- Deferred

36

& PHARMACEUTICALS LIMITED ALC4/2015 25.06.2015 HQ File :01/82/050/00277/AM16/
RLA File :03/94/040/00931/AM15/
Lic.No/Date:0310792547 01.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

148

Case No.:138/5/82-ALC4/2015 Party Name:J.B. CHEMICALS

& PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00278/AM16/
RLA File :03/94/040/00920/AM15/
Lic.No/Date:0310792544 01.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

149

Case No.:214/5/82-ALC4/2015 Party Name:LEE PHARMA

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00354/AM16/
RLA File :09/24/040/00418/AM15/
Lic.No/Date:0910061472 01.01.2015 Defer Date 16.09.2015 Pharmaceuticals

150

Case No.:225/5/82-ALC4/2015 Party Name:LEE PHARMA

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00365/AM16/
RLA File :09/24/040/00419/AM15/
Lic.No/Date:0910061473 01.01.2015 Defer Date 16.09.2015 Pharmaceuticals

151

Case No.:69/5/82-ALC4/2015 Party Name:LUPIN LIMITED

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00209/AM16/
RLA File :03/95/040/00807/AM15/
Lic.No/Date:0310792533 01.01.2015 Defer Date 16.09.2015 Pharmaceuticals

152

Case No.:70/5/82-ALC4/2015 Party Name:LUPIN LIMITED

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File RLA File Lic.No/Date:0310792532 Defer Date

37

:01/82/050/00210/AM16/
:03/95/040/00606/AM15/
01.01.2015 16.09.2015 Pharmaceuticals

153

Case No.:75/5/82-ALC4/2015 Party Name:RIOCARE INDIA

PRIVATE LIMITED. Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00215/AM16/
RLA File :03/95/040/00686/AM15/
Lic.No/Date:0310792549 01.01.2015

Decision : Committee considered the case and decided to ratify norms as per earlier decision taken in its meeting No.08/82/2014 dated 25.09.2014 under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-

Export Product Simethicone (3 Export Item)

Sl. No.
Export product Import items Qty. Allowed 1 kg Export Product

1 Simethicone 100% USP or BP or EP Silicone Fluid / Oil of relevant Viscosity
0.96 kg/kg 2 Simethicone Emulsion USP 30% Silicone Fluid / Oil of relevant Viscosity 0.288 kg/kg 3 Dimethicone USP or BP or EP (Various Viscosity) Silicone Fluid / Oil of relevant Viscosity 1.01 kg/kg

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

154

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

PHARMACHEM LTD, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00224/AM16/
RLA File :34/24/040/00259/AM15/
Lic.No/Date:3410040852 01.01.2015 Defer Date 16.09.2015 Chemicals.

155

Case No.:105/5/82-ALC4/2015 Party Name:CROWN

CHEMICALS PVT.LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00245/AM16/
RLA File :03/94/040/00864/AM15/
Lic.No/Date:0310792569 02.01.2015 Defer Date 16.09.2015 Chemicals.

156 Case No.:106/5/82-ALC4/2015 Party Name:CROWN Meet No/Date:5/82- Deferred

38

CHEMICALS PVT.LTD., ALC4/2015 25.06.2015 HQ File :01/82/050/00246/AM16/
RLA File :03/94/040/00863/AM15/
Lic.No/Date:0310792568 02.01.2015 Defer Date 16.09.2015 Chemicals.

157

Case No.:104/5/82-ALC4/2015 Party Name:ENALTEC LABS

PVT.LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00244/AM16/
RLA File :03/94/040/00929/AM15/
Lic.No/Date:0310792566 02.01.2015

Department of Pharmaceuticals vide O.M.No35011/727/2013-PI (Norms) dt. 21.4.2014 as per Export product Qty. Import items Qty.kg/kg Clopidogrel Bisulfate 1kg DL-(2-Chlorophenyl) glycine 1.05 2-Thiophene ethanol 0.707

158

Case No.:68/5/82-ALC4/2015 Party Name:POLYDRUG

LABORATORIES PVT.LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00208/AM16/
RLA File :03/95/040/00810/AM15/
Lic.No/Date:0310792570 02.01.2015 Defer Date 16.09.2015 Pharmaceuticals

159

Case No.:223/5/82-ALC4/2015 Party Name:RA CHEM

PHARMA LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00363/AM16/
RLA File :09/24/040/00559/AM15/
Lic.No/Date:0910061477 02.01.2015

Department of Pharmaceuticals vide O.M.No35011/485/2014-PI (Norms) dt. March, 2015 as per Export product Qty. Import items Qty.kg/kg Articaine Hcl 1kg Methyl-3-Amino-4-methyl Thiophene-2-Carboxylate 1.02

160 Case No.:45/5/82-ALC4/2015 Party Name:SUVEN LIFE Meet No/Date:5/82- Deferred

39

SCIENCES LIMITED ALC4/2015 25.06.2015 HQ File :01/82/050/00185/AM16/
RLA File :09/24/040/00558/AM15/
Lic.No/Date:0910061483 05.01.2015 Defer Date 16.09.2015 Pharmaceuticals

161

Case No.:255/5/82-ALC4/2015 Party Name:SUVEN LIFE

SCIENCES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00395/AM16/
RLA File :09/24/040/00548/AM15/
Lic.No/Date:0910061481 05.01.2015

Decision : In the light of the earlier decision taken by NC in its meeting No.10/82/2014 dated 12.11.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Export product Exp. Qty. Sl.No. Import items Qty. Allowed kg/kg GABAPENTIN/ 1 kg 1 1,1-Cyclohexane Diacetic Acid Monoamide 1.63 3. Acetone 1.541

162

Case No.:67/5/82-ALC4/2015 Party Name:METROPOLITAN

EXIMCHEM LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00207/AM16/
RLA File :03/95/040/00735/AM15/
Lic.No/Date:0310792622 06.01.2015 Defer Date 16.09.2015 Decision : The Committee noted that advance authorisation issued on repeat basis.
Therefore, the Committee has decided to withdraw the case.

163

Case No.:103/5/82-ALC4/2015 Party Name:AARTI

INDUSTRIES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00243/AM16/
RLA File :03/94/040/00745/AM15/
Lic.No/Date:0310792633 07.01.2015

Department of Pharmaceuticals vide O.M.No35011/459/2014-PI (Norms) dt. February, 2015 as Export product Qty. Import items Qty.kg/kg Mometasone Furoate 1kg 16 Alpha methyl Expoxide (8DM) 1.04

40

164

Case No.:102/5/82-ALC4/2015 Party Name:ALTA

LABORATORIES LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00242/AM16/
RLA File :03/94/040/00836/AM15/
Lic.No/Date:0310792635 07.01.2015 Defer Date 16.09.2015 Chemicals.

165

Case No.:116/5/82-ALC4/2015 Party Name:ARIHANTANAM

LIFECARE PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00256/AM16/
RLA File :52/24/040/00053/AM15/
Lic.No/Date:5210041380 07.01.2015

Decision : In the light of earlier decision taken in its 21/82 meeting dated 06.02.2014 , it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Export Product Export Qty. Sl.No. Import items Qty. allowed
Artemether 1 Kg. 1. Artemisinin 1.235 kg

166

Case No.:118/5/82-ALC4/2015 Party Name:ARIHANTANAM

LIFECARE PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00258/AM16/
RLA File :52/24/040/00054/AM15/
Lic.No/Date:5210041377 07.01.2015

Decision The committee decided to ratify the norms based on the recommendation of Department of Pharmaceuticals vide O.M.No35011/296/2013-PI (Norms) dt. 03.07.2015 as per Export product Qty. Import items Qty.kg/kg Dihydro Artemisinin 1kg Artemisinin 1.11

167

Case No.:107/5/82-ALC4/2015 Party Name:AVA

CHEMICALS PVT.LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00247/AM16/
RLA File :03/94/040/00933/AM15/
Lic.No/Date:0310792634 07.01.2015 Defer Date 16.09.2015 Chemicals.

168

Case No.:73/5/82-ALC4/2015 Party Name:NEW ALLIANCE

DYE-CHEM PVT. LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved

41

HQ File :01/82/050/00213/AM16/
RLA File :03/95/040/00834/AM15/
Lic.No/Date:0310792645 07.01.2015 Defer Date 16.09.2015 Decision : The Committee noted that advance authorisation issued on repeat basis.
Therefore, the Committee has decided to withdraw the case.

169

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

DYE-CHEM PVT. LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00214/AM16/
RLA File :03/95/040/00833/AM15/
Lic.No/Date:0310792647 07.01.2015 Defer Date 16.09.2015 Chemicals.

170

Case No.:149/5/82-ALC4/2015 Party Name:ALCHEMIE

LABORATORIES Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00289/AM16/
RLA File :03/94/040/00813/AM15/
Lic.No/Date:0310792673 08.01.2015 Defer Date 16.09.2015 Chemicals.

171

Case No.:148/5/82-ALC4/2015 Party Name:GLENMARK

GENERICS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00288/AM16/
RLA File :03/94/040/00948/AM15/
Lic.No/Date:0310792671 08.01.2015

Department of Pharmaceuticals vide O.M.No35011/659/2012-PI (Norms) dt. 12.3.2013 as per Export product Qty. Import items Qty.kg/kg Olmesartan Medoxomill 1kg 1 4-(1-Hydroxy-1-Methyl- Ethyl)-2-Propyl-1H- Imidazole 5-Carboxylic Acid Ethyl Ester 0.70 2 5-(4-Bromomethyl) (1,1- Biphenyl)-2YL Triphenyl-1- H Tetrazole 95% 1.786 3 4-Chloromethyl-5-Methyl- 1,3-Dioxolen 2 One 0.48 4 Dimethyl Formamide 6.72 5 Tetrahydrofuran 3.43 6 Potassium Carbonate 0.57 7 Toluene 2.41

42

172

Case No.:62/5/82-ALC4/2015 Party Name:INDO AMINES

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00202/AM16/
RLA File :03/94/040/00928/AM15/
Lic.No/Date:0310792678 08.01.2015 Defer Date 16.09.2015 O.M.No.14010/81/2010-CH-II dated 23rd July 2015 decided to call for following 3. Details of by products formed during the process and the recovery of solvents in 4. Details of production of export product under reference and corresponding

173

Case No.:63/5/82-ALC4/2015 Party Name:INDOCO

REMEDIES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00203/AM16/
RLA File :03/94/040/00936/AM15/
Lic.No/Date:0310792676 08.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

174

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

DYE-CHEM PVT. LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00262/AM16/
RLA File :03/95/040/00682/AM15/
Lic.No/Date:0310792689 08.01.2015 Defer Date 16.09.2015 Chemicals.

175

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

SCIENCES LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00261/AM16/
RLA File :03/95/040/00835/AM15/
Lic.No/Date:0310792685 08.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

43

176

Case No.:220/5/82-ALC4/2015 Party Name:AUROBINDO

PHARMA LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00360/AM16/
RLA File :09/24/040/00560/AM15/
Lic.No/Date:0910061516 09.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

177

Case No.:219/5/82-ALC4/2015 Party Name:BHAGIRADHA

CHEMICALS & INDUSTRIES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00359/AM16/
RLA File :09/24/040/00549/AM15/
Lic.No/Date:0910061517 09.01.2015 Defer Date 16.09.2015 Chemicals.

178

Case No.:80/5/82-ALC4/2015 Party Name:DHANUKA

LABORATORIES LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00220/AM16/
RLA File :05/23/040/00465/AM15/
Lic.No/Date:0510392782 09.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

179

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

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00379/AM16/
RLA File :09/24/040/00555/AM15/
Lic.No/Date:0910061520 09.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

180

Case No.:150/5/82-ALC4/2015 Party Name:ALKYL AMINES

CHEMICALS LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00290/AM16/
RLA File :03/94/040/00866/AM15/
Lic.No/Date:0310792839 12.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

181

Case No.:152/5/82-ALC4/2015 Party Name:AVA

CHEMICALS PVT.LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred

44

HQ File :01/82/050/00292/AM16/
RLA File :03/94/040/00943/AM15/
Lic.No/Date:0310792841 12.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

182

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

INDUSTRIES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00281/AM16/
RLA File :03/94/040/00746/AM15/
Lic.No/Date:0310792870 13.01.2015 Defer Date 16.09.2015 Chemicals.

183

Case No.:61/5/82-ALC4/2015 Party Name:AGIO

PHARMACEUTICALS LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00201/AM16/
RLA File :03/94/040/00868/AM15/
Lic.No/Date:0310792874 13.01.2015

Decision : In the light of the earlier decision taken by NC in its meeting No.16/82 dated 23.1.2015, it was decided to ratify the norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Export Product Export Quantity S. No. Import Item
Qty. Allowed Prednisol Solution for Injection 30mg/1ml vial Packs 1. PREDNISOLONE SOLUTION PHOSPHATE BP 40.348 mg for 1 ml vial

184

Case No.:151/5/82-ALC4/2015 Party Name:AGIO

PHARMACEUTICALS LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00291/AM16/
RLA File :03/94/040/00902/AM15/
Lic.No/Date:0310792875 13.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

185

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

LABORATORIES PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00259/AM16/
RLA File :03/95/040/00843/AM15/
Lic.No/Date:0310792869 13.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

45

186

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

CORPORATION Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00232/AM16/
RLA File :02/24/040/00203/AM15/
Lic.No/Date:0210205448 14.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

187

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

AROMATICS PVT.LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00199/AM16/
RLA File :03/94/040/00793/AM15/
Lic.No/Date:0310792911 14.01.2015 Defer Date 16.09.2015 Chemicals.

188

Case No.:64/5/82-ALC4/2015 Party Name:CLEAN SCIENCE

AND TECHNOLOGY PVT.LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00204/AM16/
RLA File :31/83/040/00200/AM15/
Lic.No/Date:3110065202 14.01.2015 Defer Date 16.09.2015 O.M.No.14010/3/2012-CH-II dated 31st July 2015 decided to call for following 3. Details of by products formed during the process and the recovery of solvents in 4. Details of production of export product under reference and corresponding

189

Case No.:66/5/82-ALC4/2015 Party Name:EMCURE

PHARMACEUTICALS LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00206/AM16/
RLA File :31/83/040/00219/AM15/
Lic.No/Date:3110065206 14.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

46

190

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

SCIENCES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00383/AM16/
RLA File :09/24/040/00589/AM15/
Lic.No/Date:0910061530 14.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

191

Case No.:51/5/82-ALC4/2015 Party Name:UNIMAX

LABORATORIES PVT.LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00191/AM16/
RLA File :03/95/040/00860/AM15/
Lic.No/Date:0310792918 14.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

192

Case No.:60/5/82-ALC4/2015 Party Name:INDOCO

REMEDIES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00200/AM16/
RLA File :03/94/040/00963/AM15/
Lic.No/Date:0310793006 16.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

193

Case No.:78/5/82-ALC4/2015 Party Name:LAXMI

ORGANIC INDUSTRIES LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00218/AM16/
RLA File :03/95/040/00814/AM15/
Lic.No/Date:0310793011 16.01.2015 Defer Date 16.09.2015 Chemicals.

194

Case No.:109/5/82-ALC4/2015 Party Name:MANGALAM

DRUGS & ORGANICS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00249/AM16/
RLA File :03/95/040/00828/AM15/
Lic.No/Date:0310793022 16.01.2015

Decision: The committee decided to ratify the norms based on the recommendation of Department of Pharmaceuticals vide O.M.No35011/434/2014-PI (Norms) dt. February, 2015 as Export product Qty. Import items Qty.kg/kg Artemether 1kg Artemisinin 1.235 Sodium Borohydride 0.188

47

Trimethyl Ortho Acetate Not required in process

195

Case No.:72/5/82-ALC4/2015 Party Name:MICRO INKS

PRIVATE LIMITED. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00212/AM16/
RLA File :03/95/040/00658/AM15/
Lic.No/Date:0310793017 16.01.2015 Defer Date 16.09.2015 Decision : : The Committee consider the case for ratification of norms under para 4.07 of Chemical.s.

196

Case No.:111/5/82-ALC4/2015 Party Name:MICRO INKS

PRIVATE LIMITED. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00251/AM16/
RLA File :03/95/040/00648/AM15/
Lic.No/Date:0310792988 16.01.2015 Defer Date 16.09.2015 Chemical.s.

197

Case No.:83/5/82-ALC4/2015 Party Name:MOREPEN

LABORATORIES LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00223/AM16/
RLA File :05/24/040/00488/AM15/
Lic.No/Date:0510392885 16.01.2015

Department of Pharmaceuticals vide O.M.No35011/488/2014-PI (Norms) dt. March, 2015 as per Export product Qty. Import items Qty.kg/kg Rosuvastatin Calcium 1kg Tert-Butyl-2-((4R,6S)-6-((E)-2-(4(- (4-fluorophenyl)- 6-isopropyl-2-[N-methyl (methylsulphonyl)amino] pyrimidin- 5-yl) vinyl)-2,2-dimethyl-1,3- dioxane-4-yl)acetate 1.425 Methanol 2.53 Tert-butyl methyl ether (MTBE) 0.79

198

Case No.:89/5/82-ALC4/2015 Party Name:CADILA

HEALTHCARE LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred

48

HQ File :01/82/050/00229/AM16/
RLA File :08/24/040/00253/AM15/
Lic.No/Date:0810134341 19.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

199

Case No.:242/5/82-ALC4/2015 Party Name:OPTIMUS

DRUGS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00382/AM16/
RLA File :09/24/040/00577/AM15/
Lic.No/Date:0910061545 19.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

200

Case No.:249/5/82-ALC4/2015 Party Name:PERKIN

LABORATORIES Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00389/AM16/
RLA File :09/24/040/00588/AM15/
Lic.No/Date:0910061539 19.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

201

Case No.:79/5/82-ALC4/2015 Party Name:UNIJULES LIFE

SCIENCES LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00219/AM16/
RLA File :03/95/040/00877/AM15/
Lic.No/Date:0310793058 19.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

202

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

CHEMICALS PVT LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00250/AM16/
RLA File :03/95/040/00811/AM15/
Lic.No/Date:0310793038 19.01.2015 Defer Date 30.09.2015 Decision : The committee observed that the CA certificate furnished by the firm in two applications reflects contradictory production and consumption data for the year 2013-14. Further ITCHS code of import and export product also needs to be corrected.

49

203

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

CHEMICALS PVT LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00252/AM16/
RLA File :03/95/040/00812/AM15/
Lic.No/Date:0310793039 19.01.2015 Defer Date 30.09.2015 Decision : The committee observed that the CA certificate furnished by the firm in two applications reflects contradictory production and consumption data for the year 2013-14. Further ITCHS code of import and export product also needs to be corrected.

20 4

Case No.:179/5/82-

ALC4/2015
Party Name:ADCOCK INGRAM LTD, Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00319/AM16/
RLA File :07/24/040/00379/AM15/
Lic.No/Date:0710107469 20.01.2015

Decision : In the light of earlier decision taken in meeting no. 04/82 dated 16.05.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed
Neulin 125 mg tablets
Theophylline 125 mg+Guar gum 4.375 mg
1 no. of Neulin Tablet 1. Theophylline BP/EP/USP Ph. EUR Anhydrous powder 127.5 mg 2. Guar Gum, 1 H (BP/EP/USP/PH. EUR) 4.375 mg Neulin 200 mg tablets Theophylline 200 mg+ Guar Gum 7.00 mg 1 no. of neuline tablet 1 Theophylline BP/EP/USP Ph. EUR Anhydrous powder 204.0 mg 2 Guar Gum, 1 H (BP/EP/USP/PH. EUR) 7.00 mg Neulin 250 mg tablets Theophylline 250 mg+ Guar Gum 8.750 mg 1 no. of neuline tablet 1 Theophylline BP/EP/USP Ph. EUR Anhydrous powder 255.0 mg 2 Guar Gum, 1 H (BP/EP/USP/PH. EUR) 8.75 mg Neulin 300 mg tablets Theophylline 300 mg+ Guar Gum 10.5 mg 1 no. of neuline tablet 1 Theophylline BP/EP/USP Ph. EUR Anhydrous powder 306.0 mg 2 Guar Gum, 1 H (BP/EP/USP/PH. EUR) 10.5 mg

50

20 5

Case No.:180/5/82-

ALC4/2015
Party Name:ADCOCK INGRAM LTD, Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00320/AM16/
RLA File :07/24/040/00380/AM15/
Lic.No/Date:0710107470 20.01.2015

Decision : In the light of earlier decision taken in meeting no. 04/82 dated 16.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed
Neulin 125 mg tablets
Theophylline 125 mg+Guar gum 4.375 mg
1 no. of Neulin Tablet 1. Theophylline BP/EP/USP Ph. EUR Anhydrous powder 127.5 mg 2. Guar Gum, 1 H (BP/EP/USP/PH. EUR) 4.375 mg Neulin 200 mg tablets Theophylline 200 mg+ Guar Gum 7.00 mg 1 no. of neuline tablet 1 Theophylline BP/EP/USP Ph. EUR Anhydrous powder 204.0 mg 2 Guar Gum, 1 H (BP/EP/USP/PH. EUR) 7.00 mg Neulin 250 mg tablets Theophylline 250 mg+ Guar Gum 8.750 mg 1 no. of neuline tablet 1 Theophylline BP/EP/USP Ph. EUR Anhydrous powder 255.0 mg 2 Guar Gum, 1 H (BP/EP/USP/PH. EUR) 8.75 mg Neulin 300 mg tablets Theophylline 300 mg+ Guar Gum 10.5 mg 1 no. of neuline tablet 1 Theophylline BP/EP/USP Ph. EUR Anhydrous powder 306.0 mg 2 Guar Gum, 1 H (BP/EP/USP/PH. EUR) 10.5 mg

206

Case No.:53/5/82-ALC4/2015 Party Name:ENALTEC LABS

PVT.LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00193/AM16/
RLA File :03/94/040/00965/AM15/
Lic.No/Date:0310793107 20.01.2015

Department of Pharmaceuticals vide O.M.No35011/619/2014-PI (Norms) dt. April, 2015 as per

Export product Qty. Import items Qty.kg/kg ROSUVASTATIN CALCIUM (R-10 ROUTE) 1kg 6-[ (1E)-2-[4-(4-FLUROPHENYL)-6- (1- METHYLETHYL)-2-[METHYL (METHYLSULFONYL)AMINO] -5-PYRIMIDINYL]ETHENYL] -2,2-DIMETHYL L-1,3-DIOXANE-4-ACETIC ACID 1,1- DIMETHYLETHYL ESTER 1.425

51

207

Case No.:54/5/82-ALC4/2015 Party Name:ENALTEC LABS

PVT.LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00194/AM16/
RLA File :03/94/040/00976/AM15/
Lic.No/Date:0310793103 20.01.2015

Department of Pharmaceuticals vide O.M.No35011/493/2014-PI (Norms) dt. March, 2015 as per Export product Qty. Import items Qty.kg/kg DEXKETOPROFEN TROMETAMOL 1kg 2-(3-BENZOYLPHENYL) PROPIONITRILE 99% MIN (KETOPROFEN NITRILE) 1.82 N-OCTYL-D-GLUCAMINE 0.36

208

Case No.:52/5/82-ALC4/2015 Party Name:INDOCO

REMEDIES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00192/AM16/
RLA File :03/94/040/00953/AM15/
Lic.No/Date:0310793104 20.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

209

Case No.:147/5/82-ALC4/2015 Party Name:INDOCO

REMEDIES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00287/AM16/
RLA File :03/94/040/00964/AM15/
Lic.No/Date:0310793105 20.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

210

Case No.:55/5/82-ALC4/2015 Party Name:IPCA

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00195/AM16/
RLA File :03/94/040/00975/AM15/
Lic.No/Date:0310793123 20.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

211

Case No.:57/5/82-ALC4/2015 Party Name:IPCA

Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved

52

HQ File :01/82/050/00197/AM16/
RLA File :03/94/040/00962/AM15/
Lic.No/Date:0310793121 20.01.2015

Department of Pharmaceuticals vide O.M.No35011/579/2014-PI (Norms) dt. May, 2015 as per Export product Qty. Import items Qty.kg/kg HYDROXY CHLOROQUINE SULPHATE 1kg 1 Acetobutyrolactone
1.4515 2 2-Ethylamino-Ethanol(Mono Ethyl Ethanolamine)

1.8434 3 Ethoxy Methylene Malonic Acid Ester [ EMME ]

1.1464 4 Metachloro Aniline 0.6746 5 S.B. Toluene 1.6773 6 Methanol 3.48 7 Iso Propyl Alcohol 1.49 8 Methylene Di Chloride

5.18

212

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

PHARMACEUTICALS PVT LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00228/AM16/
RLA File :05/23/040/00486/AM15/
Lic.No/Date:0510392949 21.01.2015 Defer Date 16.09.2015 HBP vol1. and decided to defer the case for want of comments from D/o Ayush.

213

Case No.:132/5/82-ALC4/2015 Party Name:BDR

PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00272/AM16/
RLA File :03/94/040/00947/AM15/
Lic.No/Date:0310793170 21.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

214

Case No.:56/5/82-ALC4/2015 Party Name:IPCA

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00196/AM16/
RLA File :03/94/040/00973/AM15/
Lic.No/Date:0310793182 21.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

53

215

Case No.:131/5/82-ALC4/2015 Party Name:J.B. CHEMICALS

& PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00271/AM16/
RLA File :03/94/040/00988/AM15/
Lic.No/Date:0310793181 21.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

216

Case No.:87/5/82-ALC4/2015 Party Name:SHREE BANKEY

BEHARI LAL BOARD MILLS Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00227/AM16/
RLA File :05/24/040/00454/AM15/
Lic.No/Date:0510392955 21.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

217

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

PHARMA PVT.LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00226/AM16/
RLA File :05/24/040/00489/AM15/
Lic.No/Date:0510392966 22.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

218

Case No.:170/5/82-ALC4/2015 Party Name:ALEMBIC

PHARMACEUTICALS LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00310/AM16/
RLA File :34/24/040/00278/AM15/
Lic.No/Date:3410040893 23.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

219

Case No.:165/5/82-ALC4/2015 Party Name:IND-SWIFT

LABORATORIES LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00305/AM16/
RLA File :22/24/040/00091/AM15/
Lic.No/Date:2210015173 23.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

220 Case No.:71/5/82-ALC4/2015 Party Name:MELOG SPECIALITY CHEMICALS Meet No/Date:5/82- ALC4/2015 Approved

54

PVT. LTD. 25.06.2015 HQ File :01/82/050/00211/AM16/
RLA File :03/95/040/00868/AM15/
Lic.No/Date:0310793254 23.01.2015 Defer Date 16.09.2015 Decision : The Committee noted that advance authorisation issued on repeat basis.
Therefore, the Committee has decided to withdraw the case.

221

Case No.:76/5/82-ALC4/2015 Party Name:MELOG

SPECIALITY CHEMICALS PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00216/AM16/
RLA File :03/95/040/00891/AM15/
Lic.No/Date:0310793255 23.01.2015 Defer Date 16.09.2015 Chemicals.

222

Case No.:77/5/82-ALC4/2015 Party Name:THINQ PHARMA-

CRO LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00217/AM16/
RLA File :03/95/040/00857/AM15/
Lic.No/Date:0310793256 23.01.2015 Defer Date 16.09.2015 Pharmaceutical.

223

Case No.:204/5/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00344/AM16/
RLA File :09/24/040/00596/AM15/
Lic.No/Date:0910061555 23.01.2015 Defer Date 16.09.2015 Chemicals.

224

Case No.:229/5/82-ALC4/2015 Party Name:ATUL LIMITED,

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00369/AM16/
RLA File :08/24/040/00391/AM15/
Lic.No/Date:0810134402 27.01.2015 Defer Date 16.09.2015 Chemicals.

225

Case No.:270/5/82-ALC4/2015 Party Name:INDOCO

REMEDIES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved. HQ File :01/82/050/00410/AM16/
RLA File :03/94/040/00994/AM15/
Lic.No/Date:0310793302 27.01.2015

55

Decision : The Committee decided to ratify the norms as per SION A-412 or as applied by the firm whichever is less.

226

Case No.:269/5/82-ALC4/2015 Party Name:J.B. CHEMICALS

& PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00409/AM16/
RLA File :03/94/040/01006/AM15/
Lic.No/Date:0310793301 27.01.2015 Defer Date 16.09.2015 Phamaceuticals.

227

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

ORGANICS PVT. LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00225/AM16/
RLA File :05/24/040/00500/AM15/
Lic.No/Date:0510392989 27.01.2015 Defer Date 16.09.2015 Chemical.

228

Case No.:276/5/82-ALC4/2015 Party Name:IPCA

Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00416/AM16/
RLA File :03/94/040/00997/AM15/
Lic.No/Date:0310793355 28.01.2015

Department of Pharmaceuticals vide O.M.No35011/556 /2015-PI (Norms) dt. April, 2015 as Export product Qty. Import items Qty.kg/kg Etodolac 1kg 7-Ethyl Triptophol 0.72 Methyl-3-Oxopentonoate 0.54 Methanol 1.14

229

Case No.:58/5/82-ALC4/2015 Party Name:JINDAL DRUGS

PRIVATE LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00198/AM16/
RLA File :03/94/040/00980/AM15/
Lic.No/Date:0310793360 28.01.2015 Defer Date 16.09.2015 Decision : : The Committee in light of written comments of D/o C&PC letter No.14010/31/2015-CH-II dated 15.7.2015 decided to call for following information from the firm:-

56

  1. Technical specifications , certificate of Analysis (COA) and copy of export order.
  2. Detailed manufacturing process with balanced chemical reactions indicating number of moles of all the reactants, products and by products with corresponding molecular formulae, structural formulae, molecular weight and process flow diagram.
  3. Details of other indigenous inputs to be used in the manufacture of export product.
  4. Complete material balance indicating input and output material at each stage of manufacturing process and basis of applied quantity of raw materials.
  5. Details of by product generated in the process along with their quantity and value.
  6. Details of production of export product under reference from your supporting manufacturer and corresponding consumption of raw materials in the year 2014- 15 and 2015-16 duly certified by CA may be furnished, if the production has not commenced in the past, the details from commencement of production ;may be furnished duly certified by CA.
  7. Any other relevant information, if any.

230

Case No.:230/5/82-ALC4/2015 Party Name:R.K.INDUSTRIES, Meet No/Date:5/82-

ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00370/AM16/
RLA File :08/24/040/00394/AM15/
Lic.No/Date:0810134414 28.01.2015 Defer Date 16.09.2015 Chemicals.

231

Case No.:168/5/82-ALC4/2015 Party Name:ALEMBIC

PHARMACEUTICALS LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00308/AM16/
RLA File :34/24/040/00277/AM15/
Lic.No/Date:3410040906 29.01.2015 Defer Date 16.09.2015 Phamaceuticals.

232

Case No.:282/5/82-ALC4/2015 Party Name:KRISHNA

ANTIOXIDANTS PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00422/AM16/
RLA File :03/94/040/01004/AM15/
Lic.No/Date:0310793397 29.01.2015

Department of C&PC U.O.No.14010/100/2012-CH-II dt. 15.4.2015 as per details given below or as applied by the firm whichever is less:-
Export product Qty. Import items Qty.kg/kg Triphenyl Phosphite 1kg Phenol 0.937 Yellow Phosphorus 0.100

57

233

Case No.:163/5/82-ALC4/2015 Party Name:RANBAXY

LABORATORIES LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00303/AM16/
RLA File :05/24/040/00503/AM15/
Lic.No/Date:0510393026 29.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

234

Case No.:210/5/82-

ALC4/2015
Party Name:BRUNDAVAN LABORATORIES PRIVATE LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00350/AM16/
RLA File :09/24/040/00581/AM15/
Lic.No/Date:0910061568 30.01.2015

Department of Pharmaceuticals vide O.M.No35011/ 592 /2015-PI (Norms) dt. April, 2015 as Export product Qty. Import items Qty.kg/kg 4-(2,2-Epoxypropoxy)- 9H-carbazole Powder 1kg 1 1,3-Cyclohexanedione 1.80 2 Phenylhydrazine Hydrochloride 2.56 3 Methanol 2.00 4 Hydrochloric acid(35%) Not an importable item 5 Raney Nickel 0.100 6 Potassium Hydroxide 0.591 7 Toulene 0.355 8 Epichlorohydrin 0.915 9 Dimethyl Sulfoxide Not shown in process 10 Sodium Hydroxide 0.25

235

Case No.:166/5/82-ALC4/2015 Party Name:CADILA

PHARMACEUTICALS LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00306/AM16/
RLA File :08/24/040/00386/AM15/
Lic.No/Date:0810134454 30.01.2015 Defer Date 16.09.2015 Decision : It was decided to call from the firm Past production vis-à-vis actual consumption of imported inputs duly certified by Central Excise Authorities. It was decided to deferred the case for 20.05.2015.

58

236

Case No.:274/5/82-ALC4/2015 Party Name:ELPPE

CHEMICALS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00414/AM16/
RLA File :03/94/040/01017/AM15/
Lic.No/Date:0310793439 30.01.2015 Defer Date 16.09.2015 O.M.No.14010/96/2012-CH-II dated July 2015 decided to call for following information from the firm:- 3. Details of production of export product under reference and corresponding 4. Any other relevant information, if any.

237

Case No.:211/5/82-ALC4/2015 Party Name:LEE PHARMA

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00351/AM16/
RLA File :09/24/040/00602/AM15/
Lic.No/Date:0910061571 30.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

238

Case No.:212/5/82-ALC4/2015 Party Name:LEE PHARMA

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00352/AM16/
RLA File :09/24/040/00606/AM15/
Lic.No/Date:0910061572 30.01.2015 Defer Date 16.09.2015 Pharmaceuticals.

239

Case No.:181/5/82-ALC4/2015 Party Name:R L FINE CHEM

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00321/AM16/
RLA File :07/24/040/00387/AM15/
Lic.No/Date:0710107544 02.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

240

Case No.:209/5/82-ALC4/2015 Party Name:TRIMAX BIO

SCIENCES PRIVATE LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred

59

HQ File :01/82/050/00349/AM16/
RLA File :09/24/040/00442/AM15/
Lic.No/Date:0910061573 02.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

241

Case No.:343/5/82-ALC4/2015 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00483/AM16/
RLA File :03/95/040/00905/AM15/
Lic.No/Date:0310793484 02.02.2015 Defer Date 16.09.2015 Chemicals.

242

Case No.:162/5/82-ALC4/2015 Party Name:ALKALOIDS

CORPORATION Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00302/AM16/
RLA File :02/24/040/00205/AM15/
Lic.No/Date:0210205504 03.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

243

Case No.:272/5/82-ALC4/2015 Party Name:ALKYL AMINES

CHEMICALS LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00412/AM16/
RLA File :03/94/040/00937/AM15/
Lic.No/Date:0310793546 03.02.2015

Department of C&PC U.O.No.14010/85/2012-CH-II dt. 18.6. 2015 as per details given below or as applied by the firm whichever is less:-
Export product Qty. Import items Qty.kg/kg Acetonitrile 1kg Acetic Acid 1.766

244

Case No.:208/5/82-ALC4/2015 Party Name:ASTRIX

LABORATORIES LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00348/AM16/
RLA File :09/24/040/00534/AM15/
Lic.No/Date:0910061583 03.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

60

245

Case No.:275/5/82-ALC4/2015 Party Name:BAYER

CROPSCIENCE LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00415/AM16/
RLA File :03/94/040/00930/AM15/
Lic.No/Date:0310793539 03.02.2015 Defer Date 16.09.2015 Chemicals.

246

Case No.:158/5/82-ALC4/2015 Party Name:DYNAMIC

SPECIALITY CHEMICALS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00298/AM16/
RLA File :30/24/040/00051/AM15/
Lic.No/Date:3010103361 03.02.2015 Defer Date 16.09.2015 Chemicals.

247

Case No.:233/5/82-ALC4/2015 Party Name:MOREPEN

LABORATORIES LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00373/AM16/
RLA File :05/24/040/00525/AM15/
Lic.No/Date:0510393079 04.02.2015 Defer Date 16.09.2015 Chemicals.

248

Case No.:234/5/82-ALC4/2015 Party Name:MOREPEN

LABORATORIES LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00374/AM16/
RLA File :05/24/040/00526/AM15/
Lic.No/Date:0510393080 04.02.2015 Defer Date 16.09.2015 Chemicals.

249

Case No.:213/5/82-ALC4/2015 Party Name:SATYA

DEEPTHA PHARMACEUTICALS LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00353/AM16/
RLA File :09/24/040/00615/AM15/
Lic.No/Date:0910061584 04.02.2015

Department of Pharmaceuticals vide O.M.No35011/480/2015-PI (Norms) dt. March, 2015 as Export product Qty. Import items Qty.kg/kg (1S,4R)-4-[(2-AMINO-6- CHLORO-5-FORMAMIDO-4-

N-(2-AMINO-4,6-DICHLORO-5- PYRIMIDINYL) FORMAMIDE 0.764

61

PYRIMIDINYL)AMINO]-2- CYCLO PENTENE-1- METHANOL (+)-2- AZABICYCLO[2.2.1]HEPT-5- EN-3-ONE(VINCELACTAM) 1.41 D(-)TARTARIC ACID 0.78 SODIUM BOROHYDRIDE 0.226 ISOPROPYL ALCOHOL 4.70 METHANOL 4.23 L(+) Tartaric Acid 1.23

250

Case No.:164/5/82-ALC4/2015 Party Name:SENTISS

PHARMA PVT.LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00304/AM16/
RLA File :05/24/040/00513/AM15/
Lic.No/Date:0510393078 04.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

251

Case No.:117/5/82-ALC4/2015 Party Name:ARIHANTANAM

LIFECARE PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00257/AM16/
RLA File :52/24/040/00064/AM15/
Lic.No/Date:5210041422 05.02.2015

Department of Pharmaceuticals vide O.M.No35011/ 434 /2014-PI (Norms) dt. February, 2015 Export product Qty. Import items Qty.kg/kg Artemether 1kg Artemisinin 1.235

252

Case No.:157/5/82-ALC4/2015 Party Name:IND-SWIFT

LABORATORIES LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00297/AM16/
RLA File :22/24/040/00100/AM15/
Lic.No/Date:2210015187 05.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

253

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

& PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00424/AM16/
RLA File :03/94/040/01053/AM15/
Lic.No/Date:0310793620 05.02.2015 Defer Date 16.09.2015

62

Pharmaceuticals.

254

Case No.:238/5/82-ALC4/2015 Party Name:KLJ

PLASTICIZERS LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00378/AM16/
RLA File :05/23/040/00504/AM15/
Lic.No/Date:0510393099 05.02.2015 Defer Date 16.09.2015 Chemicals.

255

Case No.:182/5/82-ALC4/2015 Party Name:MICRO LABS

LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00322/AM16/
RLA File :07/24/040/00398/AM15/
Lic.No/Date:0710107559 05.02.2015 Defer Date 16.09.2015 HBP vol1. and decided to defer the case for want of comments from D/o C&PCChemicals.

256

Case No.:155/5/82-ALC4/2015 Party Name:ONEIRO

CHEMICALS LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00295/AM16/
RLA File :34/24/040/00291/AM15/
Lic.No/Date:3410040925 05.02.2015 Defer Date 16.09.2015 O.M.No.14010/39/2012-CH-II dated 31st July 2015 decided to call for following 3. Details of by products formed during the process and the recovery of solvents in 4. Details of production of export product under reference and corresponding consumption of raw material in the year 2014-15duly certified by CA.

257

Case No.:169/5/82-ALC4/2015 Party Name:TIDE

INDUSTRIES Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00309/AM16/
RLA File :34/24/040/00290/AM15/
Lic.No/Date:3410040927 05.02.2015 Defer Date 16.09.2015 HBP vol1. and decided to defer the case for want of comments from D/o

63

C&PCChemicals.

258

Case No.:268/5/82-ALC4/2015 Party Name:CATAPHARMA

CHEMICALS PVT. LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00408/AM16/
RLA File :31/83/040/00209/AM15/
Lic.No/Date:3110065261 06.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

259

Case No.:287/5/82-ALC4/2015 Party Name:BLUE CIRCLE

ORGANICS PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00427/AM16/
RLA File :03/94/040/00925/AM15/
Lic.No/Date:0310793728 09.02.2015 Defer Date
Decision : : The committee decided to ratify the norms based on the recommendation of Department of Pharmaceuticals vide O.M.No35011/413/2012-PI (Norms) dt. September, 2012 Export product Qty. Import items Qty.kg/kg 5-NITRO ISOPHTHALIC ACID DIMETHYL ETSER 1kg Isophthalic Acid 0.90

  1. RA may take further action accordingly.

260

Case No.:227/5/82-ALC4/2015 Party Name:MICRO LABS

LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00367/AM16/
RLA File :07/24/040/00378/AM15/
Lic.No/Date:0710107574 09.02.2015 Defer Date 16.09.2015 Chemicals.

261

Case No.:342/5/82-ALC4/2015 Party Name:NAVIN

FLUORINE INTERNATIONAL LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00482/AM16/
RLA File :03/95/040/00585/AM15/
Lic.No/Date:0310793707 09.02.2015 Defer Date 16.09.2015 Chemicals.

262

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

FLUORINE INTERNATIONAL LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00484/AM16/
RLA File :03/95/040/00445/AM15/
Lic.No/Date:0310793706 09.02.2015 Defer Date 16.09.2015

64

Chemicals.

263

Case No.:161/5/82-ALC4/2015 Party Name:PAYAL

PETROCHEM PRIVATE LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00301/AM16/
RLA File :05/24/040/00472/AM15/
Lic.No/Date:0510393118 09.02.2015 Defer Date 16.09.2015 Chemicals.

264

Case No.:346/5/82-ALC4/2015 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00486/AM16/
RLA File :03/95/040/00947/AM15/
Lic.No/Date:0310793722 09.02.2015 Defer Date 16.09.2015 Chemicals.

265

Case No.:319/5/82-ALC4/2015 Party Name:EXEMED

PHARMACEUTICALS Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00459/AM16/
RLA File :34/24/040/00297/AM15/
Lic.No/Date:3410040950 10.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

266

Case No.:190/5/82-ALC4/2015 Party Name:HONOUR LAB

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00330/AM16/
RLA File :09/24/040/00629/AM15/
Lic.No/Date:0910061597 10.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

267

Case No.:290/5/82-ALC4/2015 Party Name:IND-SWIFT

LABORATORIES LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00430/AM16/
RLA File :22/24/040/00098/AM15/
Lic.No/Date:2210015190 10.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

65

268

Case No.:231/5/82-ALC4/2015 Party Name:MAHARSHI

PHARMA CHEM PVT.LTD, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00371/AM16/
RLA File :08/24/040/00403/AM15/
Lic.No/Date:0810134561 10.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

269

Case No.:278/5/82-ALC4/2015 Party Name:AGIO

PHARMACEUTICALS LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00418/AM16/
RLA File :03/94/040/00941/AM15/
Lic.No/Date:0310793767 11.02.2015

Decision : In the light of the earlier decision taken by NC in its meeting No.16/82 dated 23.1.2015, it was decided to ratify the norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Export Product Export Quantity S. No. Import Item
Qty. Allowed Prednisol Solution for Injection 30mg/1ml vial Packs 1. PREDNISOLONE SOLUTION PHOSPHATE BP 40.348 mg for 1 ml vial

270

Case No.:167/5/82-ALC4/2015 Party Name:FRESENIUS

KABI ONCOLOGY LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00307/AM16/
RLA File :05/23/040/00435/AM15/
Lic.No/Date:0510393162 11.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

271

Case No.:171/5/82-ALC4/2015 Party Name:FRESENIUS

KABI ONCOLOGY LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00311/AM16/
RLA File :05/23/040/00434/AM15/
Lic.No/Date:0510393163 11.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

272

Case No.:286/5/82-ALC4/2015 Party Name:GALAXY

SURFACTANTS LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File RLA File Lic.No/Date:0310793796 Defer Date

66

:01/82/050/00426/AM16/
:03/94/040/01054/AM15/
11.02.2015 16.09.2015 Chemicals.

273

Case No.:348/5/82-ALC4/2015 Party Name:NEW ALLIANCE

DYE-CHEM PVT. LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00488/AM16/
RLA File :03/95/040/00895/AM15/
Lic.No/Date:0310793791 11.02.2015 Defer Date 16.09.2015 Decision : : The committee in light of the written comment of D/o C&PC forwarded vide O.M.No.14010/39/2012-CH-II dated 31st July 2015 decided to call for following 3. Details of production of export product under reference and corresponding consumption of raw material in the year 2014-15duly certified by CA. 4. Any other relevant information, if any.

274

Case No.:159/5/82-ALC4/2015 Party Name:PAYAL

PETROCHEM PRIVATE LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00299/AM16/
RLA File :05/24/040/00484/AM15/
Lic.No/Date:0510393136 11.02.2015 Defer Date 16.09.2015 Chemicals.

275

Case No.:160/5/82-ALC4/2015 Party Name:PCL OIL &

SOLVENTS LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00300/AM16/
RLA File :05/24/040/00389/AM15/
Lic.No/Date:0510393132 11.02.2015 Defer Date 16.09.2015 Chemicals.

276

Case No.:333/5/82-ALC4/2015 Party Name:MEHTA API PVT

LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00473/AM16/
RLA File :03/95/040/00903/AM15/
Lic.No/Date:0310793861 12.02.2015 Defer Date 16.09.2015

67

Pharmaceuticals.

277

Case No.:345/5/82-ALC4/2015 Party Name:NAVIN

FLUORINE INTERNATIONAL LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00485/AM16/
RLA File :03/95/040/00909/AM15/
Lic.No/Date:0310793856 12.02.2015 Defer Date 16.09.2015 Chemicals.

278

Case No.:347/5/82-ALC4/2015 Party Name:ROYAL PHARMA Meet No/Date:5/82-

ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00487/AM16/
RLA File :03/95/040/00958/AM15/
Lic.No/Date:0310793866 12.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

279

Case No.:201/5/82-ALC4/2015 Party Name:AKZO NOBEL

INDIA LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00341/AM16/
RLA File :02/24/040/00178/AM15/
Lic.No/Date:0210205557 13.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

28 0

Case No.:228/5/82-

ALC4/2015
Party Name:ARIHANTANAM LIFECARE PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00368/AM16/
RLA File :52/24/040/00066/AM15/
Lic.No/Date:5210041427 13.02.2015

Decision : In the light of earlier decision taken in meeting no. 03/82 dated 08.05.2014, it was decided to ratify norms under Para 4.07 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Export product Exp. Qty. Sl.No. Import items Qty. allowed (kg) Lumefantrine 1 kg 1. (Dibutylamine Methyl)- 2,7-Dichloro-4-fluoren Methanol (DBA) 0.8693 kg

281 Case No.:330/5/82-ALC4/2015 Party Name:SURVIVAL Meet No/Date:5/82- Deferred

68

TECHNOLOGIES PVT.LTD. ALC4/2015 25.06.2015 HQ File :01/82/050/00470/AM16/
RLA File :03/95/040/00901/AM15/
Lic.No/Date:0310793891 16.02.2015 Defer Date 16.09.2015 Chemicals.

282

Case No.:42/5/82-ALC4/2015 Party Name:SUVEN LIFE

SCIENCES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00182/AM16/
RLA File :09/24/040/00633/AM15/
Lic.No/Date:0910061619 16.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

283

Case No.:331/5/82-ALC4/2015 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00471/AM16/
RLA File :03/95/040/00971/AM15/
Lic.No/Date:0310793898 16.02.2015 Defer Date 16.09.2015 Chemicals.

284

Case No.:253/5/82-ALC4/2015 Party Name:MOREPEN

LABORATORIES LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00393/AM16/
RLA File :05/24/040/00548/AM15/
Lic.No/Date:0510393250 17.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

285

Case No.:30/5/82-ALC4/2015 Party Name:SRINI

PHARMACEUTICALS LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00170/AM16/
RLA File :09/24/040/00597/AM15/
Lic.No/Date:0910061627 17.02.2015

Department of Pharmaceuticals vide O.M.No35011/ 508 /2013-PI (Norms) dt. June, 2015 as Export product Qty. Import items Qty.kg/kg METHYL ALPHA-(4,5,6,7- TETRAHYDRA-5-THIENO(3,2- C)PYRIDYL)(2- CHLOROPHENYL)ACETATE 1kg 4,5,6,7 - TETRAHYDROTHIENO (3,2 -C) PYRIDINE HYDROCHLORIDE
0.74

69

HYDROCHLORIDE (CPG-20) METHYL ISO BUTYL KETONE (MIBK) 1.092 ETHYLENE DI CHLORIDE / DI CHLORO ETHANE 2.508

286

Case No.:235/5/82-ALC4/2015 Party Name:AMANTA

HEALTHCARE LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00375/AM16/
RLA File :08/24/040/00413/AM15/
Lic.No/Date:0810134610 18.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

287

Case No.:281/5/82-ALC4/2015 Party Name:IPCA

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00421/AM16/
RLA File :03/94/040/01069/AM15/
Lic.No/Date:0310793943 18.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

288

Case No.:283/5/82-ALC4/2015 Party Name:J.B. CHEMICALS

& PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00423/AM16/
RLA File :03/94/040/01084/AM15/
Lic.No/Date:0310793953 18.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

289

Case No.:349/5/82-ALC4/2015 Party Name:PREGNA

INTERNATIONAL LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00489/AM16/
RLA File :03/95/040/00984/AM15/
Lic.No/Date:0310793937 18.02.2015 Defer Date 16.09.2015 HBP vol1. and decided to defer the case for want of comments from D/o C&PC Petro Chemicals.

290

Case No.:285/5/82-ALC4/2015 Party Name:CAMPHOR &

ALLIED PRODUCTS LIMITED, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00425/AM16/
RLA File :03/94/040/01092/AM15/
Lic.No/Date:0310793985 19.02.2015 Defer Date 16.09.2015

70

Chemicals.

291

Case No.:279/5/82-ALC4/2015 Party Name:CROWN

CHEMICALS PVT.LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00419/AM16/
RLA File :03/94/040/01088/AM15/
Lic.No/Date:0310793983 19.02.2015 Defer Date 16.09.2015 Chemicals.

292

Case No.:288/5/82-ALC4/2015 Party Name:CROWN

CHEMICALS PVT.LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00428/AM16/
RLA File :03/94/040/01089/AM15/
Lic.No/Date:0310793982 19.02.2015 Defer Date 16.09.2015 Chemicals.

293

Case No.:237/5/82-ALC4/2015 Party Name:INTAS

PHARMACEUTICALS LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00377/AM16/
RLA File :08/24/040/00423/AM15/
Lic.No/Date:0810134636 19.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

294

Case No.:332/5/82-ALC4/2015 Party Name:O C

SPECIALITIES PVT.LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00472/AM16/
RLA File :03/95/040/00991/AM15/
Lic.No/Date:0310794000 19.02.2015 Defer Date 16.09.2015 Chemicals.

295

Case No.:194/5/82-ALC4/2015 Party Name:SHASUN

PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00334/AM16/
RLA File :04/24/040/00278/AM15/
Lic.No/Date:0410160175 19.02.2015

Department of Pharmaceuticals vide O.M.No35011/ 15 /2015-PI (Norms) dt. 22nd July, 2015 as

71

Export product Qty. Import items Qty.allowed per tablet METOPROLOL TARTRATE TABLETS USP 25 MG 1 tablet METOPROLOL TARTRATE 25.50mg Magnesium Stearate 1.49mg Micro Crystalline Cellulose
75.21mg Croscarmellose Sodium 11.92mg Closure As per packing policy Plastic Bottles As per packing policy

296

Case No.:195/5/82-ALC4/2015 Party Name:SHASUN

PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00335/AM16/
RLA File :04/24/040/00277/AM15/
Lic.No/Date:0410160174 19.02.2015

Decision : : The committee decided to ratify the norms based on the recommendation of Department of Pharmaceuticals vide O.M.No35011/ 15 /2015-PI (Norms) dt. 22nd July, 2015 as Export product Qty. Import items Qty.allowed per tablet METOPROLOL TARTRATE TABLETS USP 25 MG 1 tablet METOPROLOL TARTRATE 25.50mg Magnesium Stearate 1.49mg Micro Crystalline Cellulose
75.21mg Croscarmellose Sodium 11.92mg Closure As per packing policy Plastic Bottles As per packing policy

297

Case No.:317/5/82-ALC4/2015 Party Name:AMI

LIFESCIENCES P LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00457/AM16/
RLA File :34/24/040/00305/AM15/
Lic.No/Date:3410040974 20.02.2015 Defer Date 16.09.2015

72

Pharmaceuticals.

298

Case No.:38/5/82-ALC4/2015 Party Name:MYLAN

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00178/AM16/
RLA File :09/24/040/00591/AM15/
Lic.No/Date:0910061638 20.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

299

Case No.:335/5/82-ALC4/2015 Party Name:PRIVI ORGANICS

LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00475/AM16/
RLA File :03/95/040/00978/AM15/
Lic.No/Date:0310794038 20.02.2015 Defer Date 16.09.2015 Chemicals.

300

Case No.:320/5/82-ALC4/2015 Party Name:GULBRANDSEN

CHEMICALS PVT LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00460/AM16/
RLA File :34/24/040/00313/AM15/
Lic.No/Date:3410040975 23.02.2015 Defer Date 16.09.2015 Chemicals.

301

Case No.:31/5/82-ALC4/2015 Party Name:SRIAM LABS

PRIVATE LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00171/AM16/
RLA File :09/24/040/00630/AM15/
Lic.No/Date:0910061641 23.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

302

Case No.:318/5/82-ALC4/2015 Party Name:TIDE

INDUSTRIES Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00458/AM16/
RLA File :34/24/040/00310/AM15/
Lic.No/Date:3410040978 23.02.2015 Defer Date 16.09.2015 Chemicals.

73

303

Case No.:267/5/82-ALC4/2015 Party Name:EMCURE

PHARMACEUTICALS LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00407/AM16/
RLA File :31/83/040/00247/AM15/
Lic.No/Date:3110065295 24.02.2015

Department of Pharmaceuticals vide O.M.No35011/ 537 /2014-PI (Norms) dt. April, 2015 as Export product Qty. Import items Qty.kg/kg ATAZANAVIR SULFATE 1kg EPOXIDE{BOC-Epoxide} 0.49 T-BOC HYDRAZINE 0.50 N-METHOXYCARBONYL-L- TERT LEUCINE 0.77 EDAC-HCL 1-(3- DIMETHYLAMINOPROPYL)- 3-ETHYLCARBODIIMIDE HYDROCHLORIDE 0.79

304

Case No.:280/5/82-ALC4/2015 Party Name:FERMENTA

BIOTECH LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00420/AM16/
RLA File :03/94/040/01110/AM15/
Lic.No/Date:0310794101 24.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

305

Case No.:293/5/82-ALC4/2015 Party Name:MAHARSHI

PHARMA CHEM PVT.LTD, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00433/AM16/
RLA File :08/24/040/00426/AM15/
Lic.No/Date:0810134657 24.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

306

Case No.:250/5/82-ALC4/2015 Party Name:PAYAL

PETROCHEM PRIVATE LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00390/AM16/
RLA File :05/24/040/00528/AM15/
Lic.No/Date:0510393339 24.02.2015 Defer Date 16.09.2015 HBP vol1. and decided to defer the case for want of comments from D/o C&PC Petro Chemcials.

74

307

Case No.:251/5/82-ALC4/2015 Party Name:PAYAL

PETROCHEM PRIVATE LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00391/AM16/
RLA File :05/24/040/00538/AM15/
Lic.No/Date:0510393340 24.02.2015 Defer Date 16.09.2015 Chemicals..

308

Case No.:252/5/82-ALC4/2015 Party Name:PAYAL

PETROCHEM PRIVATE LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00392/AM16/
RLA File :05/24/040/00544/AM15/
Lic.No/Date:0510393341 24.02.2015 Defer Date 16.09.2015 Chemicals.

309

Case No.:232/5/82-ALC4/2015 Party Name:RANBAXY

LABORATORIES LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00372/AM16/
RLA File :05/24/040/00560/AM15/
Lic.No/Date:0510393348 24.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

310

Case No.:254/5/82-ALC4/2015 Party Name:RANBAXY

LABORATORIES LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00394/AM16/
RLA File :05/24/040/00554/AM15/
Lic.No/Date:0510393347 24.02.2015

Department of Pharmaceuticals vide O.M.No35011/ 186 /2015-PI (Norms) dt. 9th May, 2015

Export product Qty. Import items Qty.kg/kg Orlistat 1kg 1 (S)-(-)-2,2- Bis(diphenylphosphino)-1,1- binaphthyl 0.003 2 2 Methoxy Propene 3.246 3 Acetone 3.82 4 Activated Carbon 0.100 5 Dicyclohexyl carbodiimide 1.003 6 DIISOBUTYL ALUMINIUM 6.606

75

HYDRIDE 7 Dimethyl Formamide 0.057 8 Formic Acid 0.52 9 L-Leucine 0.46 10 Lithium Hexamethyldisilazide in THF (UNDISTILLED) 1.971 11 Methylene Chloride 12.23 12 Meldrum Acid 2.095 13 Methanol 19.45 14 N-Hexane 4.15 15 N-Octanoyl Benzotriazole 2.809 16 Palladium Sponge 0.0004 17 Pivaloyl Chloride 0.841 18 Pyridine 0.58 19 Dichloro-(p-cymene)-ruthenium (II)-dimer 0.001 20 Tetrahydrofuran 4.53 21 Toluene 12.78 22 Triethylamine 0.774

311

Case No.:334/5/82-ALC4/2015 Party Name:UPL

LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00474/AM16/
RLA File :03/95/040/00862/AM15/
Lic.No/Date:0310794100 24.02.2015 Defer Date 16.09.2015 Chemicals.

312

Case No.:327/5/82-ALC4/2015 Party Name:GLENMARK

GENERICS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00467/AM16/
RLA File :03/94/040/01068/AM15/
Lic.No/Date:0310794143 25.02.2015

Department of Pharmaceuticals vide O.M.No35011/ 448 /2014-PI (Norms) dt. January, 2015 as Export product Qty. Import items Qty.kg/kg Bupropion Hydrochloride USP 1kg M-Chloropiophenone 0.85 Methylene Chloride 2.00 Methanol 0.23

313 Case No.:328/5/82-ALC4/2015 Party Name:GLENMARK Meet No/Date:5/82- Approved

76

GENERICS LIMITED ALC4/2015 25.06.2015 HQ File :01/82/050/00468/AM16/
RLA File :03/94/040/01076/AM15/
Lic.No/Date:0310794141 25.02.2015

Department of Pharmaceuticals vide O.M.No35011/ 447/2014-PI (Norms) dt. January, 2015 as Export product Qty. Import items Qty.kg/kg Telmisartan 1kg 1 2n-Propyl-4-methyl-6-(1- methyl benzimidazole-2- yl)benzimidazole 0.82 2 4-Methyl- 2biphenylcarboxylic Acid Methyl Ester 0.60 3 Acetone 0.46 4 Ethylene Dichloride 1.69 5 Methanol 0.43 6 Methylene Chloride 2.96 7 Methylisobutyl ketone 0.72 8 N-Bromo Succinimide 0.52

314

Case No.:277/5/82-ALC4/2015 Party Name:INDO AMINES

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00417/AM16/
RLA File :03/94/040/01024/AM15/
Lic.No/Date:0310794134 25.02.2015 Defer Date 16.09.2015 O.M.No.14010/81/2010-CH-II dated 23rd July 2015 decided to call for following information from the firm:

  1. Details of production of export product under reference and corresponding consumption of raw materials in the year 2014-15 duly certified by CA. Any other relevant information, if any.

315

Case No.:308/5/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00448/AM16/
RLA File :05/24/040/00511/AM15/
Lic.No/Date:0510393355 25.02.2015 Defer Date 16.09.2015 HBP vol1. and decided to defer the case for want of comments from D/o C&PC Petro- Chemicals.

316

Case No.:309/5/82-ALC4/2015 Party Name:SHREE

VALLABH CHEMICAL Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred

77

HQ File :01/82/050/00449/AM16/
RLA File :08/24/040/00417/AM15/
Lic.No/Date:0810134670 25.02.2015 Defer Date 16.09.2015 Chemicals.

317

Case No.:259/5/82-

ALC4/2015
Party Name:VIRDEV INTERMEDIATES PVT LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00399/AM16/
RLA File :52/24/040/00067/AM15/
Lic.No/Date:5210041437 25.02.2015 Defer Date 16.09.2015 O.M.No.14010/34/2015-CH-II dated 31st July 2015 decided to call for following 3. Details of by products formed during the process and the recovery of solvents in 4. Details of production of export product under reference and corresponding

318

Case No.:307/5/82-ALC4/2015 Party Name:ZEE

LABORATORIES Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00447/AM16/
RLA File :05/24/040/00561/AM15/
Lic.No/Date:0510393357 25.02.2015 Defer Date 16.09.2015 Decision : The Committee decided to ratify norms as per SION A-412 or as applied by the firm whichever is less. RA concerned may take action accordingly.

319

Case No.:41/5/82-ALC4/2015 Party Name:DR REDDYS

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00181/AM16/
RLA File :09/24/040/00657/AM15/
Lic.No/Date:0910061651 26.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

320

Case No.:314/5/82-ALC4/2015 Party Name:R L FINE CHEM

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00454/AM16/
RLA File :07/24/040/00416/AM15/
Lic.No/Date:0710107713 26.02.2015 Defer Date 16.09.2015

78

Pharmaceuticals.

321

Case No.:325/5/82-ALC4/2015 Party Name:SWISS EXPORTS

PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00465/AM16/
RLA File :08/24/040/00401/AM15/
Lic.No/Date:0810134676 26.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

322

Case No.:273/5/82-ALC4/2015 Party Name:BHARAT

SERUMS & VACCINES LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00413/AM16/
RLA File :03/94/040/01055/AM15/
Lic.No/Date:0310794262 27.02.2015 Defer Date 16.09.2015 HBP vol1. and decided to defer the case for want of comments from D/o Biotechnology.

323

Case No.:452/5/82-ALC4/2015 Party Name:BLUE CIRCLE

ORGANICS PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00592/AM16/
RLA File :03/94/040/01091/AM15/
Lic.No/Date:0310794261 27.02.2015 Defer Date 16.09.2015 Chemicals.

324

Case No.:296/5/82-ALC4/2015 Party Name:HPL ADDITIVES

LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00436/AM16/
RLA File :05/23/040/00524/AM15/
Lic.No/Date:0510393405 27.02.2015

Department of C&PC U.O. No.14010/7/2011 Ch-II dt. 29.5.2015 as per details given below or as applied by the firm whichever is less:-
Export product Qty. Import items Qty.kg/kg Azodicarbonamide 1kg Hydrazine Hydrate (100%) 0.548 Technical Grade Urea 1.316

325

Case No.:297/5/82-ALC4/2015 Party Name:HPL ADDITIVES

LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred

79

HQ File :01/82/050/00437/AM16/
RLA File :05/23/040/00510/AM15/
Lic.No/Date:0510393404 27.02.2015 Defer Date 16.09.2015 Chemicals.

326

Case No.:298/5/82-ALC4/2015 Party Name:MEDICEF

PHARMA, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00438/AM16/
RLA File :22/24/040/00095/AM15/
Lic.No/Date:2210015200 27.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

327

Case No.:312/5/82-ALC4/2015 Party Name:R L FINE CHEM

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00452/AM16/
RLA File :07/24/040/00415/AM15/
Lic.No/Date:0710107728 27.02.2015 Defer Date 16.09.2015 Pharmaceuticals.

328

Case No.:414/5/82-ALC4/2015 Party Name:KRISHNA

ANTIOXIDANTS PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00554/AM16/
RLA File :03/94/040/01090/AM15/
Lic.No/Date:0310794291 02.03.2015 Defer Date 16.09.2015 Chemicals.

329

Case No.:336/5/82-ALC4/2015 Party Name:MANGALAM

DRUGS & ORGANICS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00476/AM16/
RLA File :03/95/040/00998/AM15/
Lic.No/Date:0310794278 02.03.2015

Department of Pharmaceuticals vide O.M.No35011/ 434 /2014-PI (Norms) dt. February, 2015 Export product Qty. Import items Qty.kg/kg Artemether 1kg Artemisinin 1.235 Sodium Borohydride 0.188 Trimethyl Ortho Acetate Not required in process

80

330

Case No.:337/5/82-ALC4/2015 Party Name:MANGALAM

DRUGS & ORGANICS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00477/AM16/
RLA File :03/95/040/01001/AM15/
Lic.No/Date:0310794280 02.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

331

Case No.:341/5/82-ALC4/2015 Party Name:MANGALAM

DRUGS & ORGANICS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00481/AM16/
RLA File :03/95/040/01002/AM15/
Lic.No/Date:0310794281 02.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

332

Case No.:338/5/82-ALC4/2015 Party Name:UNICHEM

Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00478/AM16/
RLA File :03/95/040/01006/AM15/
Lic.No/Date:0310794283 02.03.2015

Decision : : In the light of the earlier decision taken by NC in its meeting No.17/82 dated
5.2.2015, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Export product Exp. Qty. Sl.No. Import items Qty. allowed /75 mg tablet CLOPIDOGREL 75MG TABLET Number 1. CLOPIDOGREL HYDROGENSULPHATE 99.82 mg

333

Case No.:339/5/82-ALC4/2015 Party Name:UNICHEM

Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00479/AM16/
RLA File :03/95/040/01007/AM15/
Lic.No/Date:0310794284 02.03.2015

Decision : : In the light of In the light of the earlier decision taken by NC in its meeting No.17/82 dated 5.2.2015, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Export product Exp. Qty. Sl.No. Import items Qty. allowed /75 mg

81

tablet CLOPIDOGREL 75MG TABLET Number 1. CLOPIDOGREL HYDROGENSULPHATE 99.82 mg

334

Case No.:316/5/82-ALC4/2015 Party Name:ALEMBIC

PHARMACEUTICALS LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00456/AM16/
RLA File :34/24/040/00280/AM15/
Lic.No/Date:3410041005 03.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

335

Case No.:295/5/82-ALC4/2015 Party Name:PROLIFE

INDUSTRIES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00435/AM16/
RLA File :08/24/040/00395/AM15/
Lic.No/Date:0810134703 03.03.2015 Defer Date 16.09.2015 Chemicals.

336

Case No.:313/5/82-ALC4/2015 Party Name:STERICON

PHARMA PVT.LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00453/AM16/
RLA File :07/24/040/00431/AM15/
Lic.No/Date:0710107750 03.03.2015

Decision : Committee considered the case as per agenda and in light of earlier decision taken by NC in its meeting No.07/82 dated 11.9.2014 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-

Export Product
VIZULIZE MOISTURIZING AND COMFORT EYE DROPS

Sl. No.
Import Item

For Export of 1 No. Bottle Export Item No. 1 Export Item No. 2 Export Item No. 3 Export Item No. 4 1 SOFT BOTTLE 7906/0007 Relevant as per packing policy 2 WHITE CAP 8417/0001 3 DROPPER 6049/0001 4 SODIUM HYALURONATE
0.01 gm 0.03 gm N.A. N.A

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

337 Case No.:294/5/82-ALC4/2015 Party Name:ATUL INTERMEDIATES Meet No/Date:5/82- ALC4/2015 Deferred

82

25.06.2015 HQ File :01/82/050/00434/AM16/
RLA File :08/24/040/00264/AM15/
Lic.No/Date:0810134727 04.03.2015 Defer Date 16.09.2015 Chemicals.

338

Case No.:326/5/82-ALC4/2015 Party Name:ATUL

INTERMEDIATES Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00466/AM16/
RLA File :08/24/040/00429/AM15/
Lic.No/Date:0810134726 04.03.2015 Defer Date 16.09.2015 Chemicals.

339

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

PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00555/AM16/
RLA File :03/94/040/01111/AM15/
Lic.No/Date:0310794368 04.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

340

Case No.:422/5/82-ALC4/2015 Party Name:ENCUBE

ETHICALS PVT LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00562/AM16/
RLA File :03/94/040/01120/AM15/
Lic.No/Date:0310794347 04.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

341

Case No.:451/5/82-ALC4/2015 Party Name:J.B. CHEMICALS

& PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00591/AM16/
RLA File :03/94/040/01097/AM15/
Lic.No/Date:0310794354 04.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

342

Case No.:324/5/82-ALC4/2015 Party Name:SWISS

PARENTERALS PVT.LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00464/AM16/
RLA File :08/24/040/00439/AM15/
Lic.No/Date:0810134729 04.03.2015 Defer Date 16.09.2015

83

Pharmaceuticals.

343

Case No.:340/5/82-ALC4/2015 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00480/AM16/
RLA File :03/95/040/01027/AM15/
Lic.No/Date:0310794375 04.03.2015 Defer Date 16.09.2015 Chemicals.

344

Case No.:303/5/82-ALC4/2015 Party Name:ASSOCIATED

DYESTUFF PVT. LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00443/AM16/
RLA File :08/24/040/00422/AM15/
Lic.No/Date:0810134739 05.03.2015 Defer Date 16.09.2015 Chemicals.

345

Case No.:304/5/82-ALC4/2015 Party Name:DHANUKA

LABORATORIES LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00444/AM16/
RLA File :05/23/040/00538/AM15/
Lic.No/Date:0510393485 05.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

346

Case No.:306/5/82-ALC4/2015 Party Name:DHANUKA

LABORATORIES LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00446/AM16/
RLA File :05/23/040/00537/AM15/
Lic.No/Date:0510393484 05.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

347

Case No.:39/5/82-ALC4/2015 Party Name:GRANULES

INDIA LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00179/AM16/
RLA File :09/24/040/00650/AM15/
Lic.No/Date:0910061669 05.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

84

348

Case No.:11/5/82-ALC4/2015 Party Name:LEE PHARMA

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00151/AM16/
RLA File :09/24/040/00670/AM15/
Lic.No/Date:0910061666 05.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

349

Case No.:444/5/82-ALC4/2015 Party Name:AARTI

INDUSTRIES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00584/AM16/
RLA File :03/94/040/01132/AM15/
Lic.No/Date:0310794412 09.03.2015 Defer Date 16.09.2015 Decision : The Committee in light of written comment of D/o C&PC No.14010/21/2013/CH-II dt. 31st July, 2015 decided to call for following information from the firm:-

  1. Details of production of export product under reference and corresponding consumption of raw material in the year 2013-14 and 2014-15 duly certified by CA.
  2. Any other relevant information.

350

Case No.:323/5/82-ALC4/2015 Party Name:ADCOCK

INGRAM LTD, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00463/AM16/
RLA File :07/24/040/00444/AM15/
Lic.No/Date:0710107772 09.03.2015 Defer Date 16.09.2015 Chemicals.

351

Case No.:453/5/82-ALC4/2015 Party Name:BLUE CIRCLE

ORGANICS PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00593/AM16/
RLA File :03/94/040/01016/AM15/
Lic.No/Date:0310794413 09.03.2015

Department of Pharmaceuticals vide O.M.No35011/413/2012-PI (Norms) dt. September, 2012 Export product Qty. Import items Qty.kg/kg 5-NITRO ISOPHTHALIC ACID DIMETHYL ETSER 1kg Isophthalic Acid 0.90

352

Case No.:299/5/82-ALC4/2015 Party Name:G.G.CHEMICALS

& PHARMACEUTICALS PVT.LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred

85

HQ File :01/82/050/00439/AM16/
RLA File :22/24/040/00106/AM15/
Lic.No/Date:2210015206 09.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

353

Case No.:423/5/82-ALC4/2015 Party Name:INDOCO

REMEDIES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00563/AM16/
RLA File :03/94/040/01116/AM15/
Lic.No/Date:0310794418 09.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

354

Case No.:445/5/82-ALC4/2015 Party Name:ELPPE

CHEMICALS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00585/AM16/
RLA File :03/94/040/01143/AM15/
Lic.No/Date:0310794485 10.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

355

Case No.:13/5/82-ALC4/2015 Party Name:MYLAN

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00153/AM16/
RLA File :09/24/040/00343/AM15/
Lic.No/Date:0910061674 10.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

356

Case No.:402/5/82-ALC4/2015 Party Name:POLYDRUG

LABORATORIES PVT.LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00542/AM16/
RLA File :03/95/040/01024/AM15/
Lic.No/Date:0310794467 10.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

357

Case No.:434/5/82-ALC4/2015 Party Name:POLYDRUG

LABORATORIES PVT.LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00574/AM16/
RLA File :03/95/040/01025/AM15/
Lic.No/Date:0310794472 10.03.2015 Defer Date 16.09.2015

86

Pharmaceuticals.

358

Case No.:300/5/82-ALC4/2015 Party Name:ADVANCE

PETROCHEMICALS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00440/AM16/
RLA File :08/24/040/00448/AM15/
Lic.No/Date:0810134768 11.03.2015 Defer Date 16.09.2015 petrochemicals.

359

Case No.:450/5/82-ALC4/2015 Party Name:J.B. CHEMICALS

& PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00590/AM16/
RLA File :03/94/040/01114/AM15/
Lic.No/Date:0310794517 11.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

360

Case No.:435/5/82-ALC4/2015 Party Name:MANGALAM

DRUGS & ORGANICS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00575/AM16/
RLA File :03/95/040/01037/AM15/
Lic.No/Date:0310794511 11.03.2015

Department of Pharmaceuticals vide O.M.No35011/434/2014-PI (Norms) dt. February, 2015 as Export product Qty. Import items Qty.kg/kg Artemether 1kg Artemisinin 1.235 Sodium Borohydride 0.188 Trimethyl Ortho Acetate Not required in process

36 1

Case No.:437/5/82-

ALC4/2015
Party Name:MANGALAM DRUGS & ORGANICS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00577/AM16/
RLA File :03/95/040/01038/AM15/
Lic.No/Date:0310794513 11.03.2015

Decision : : In the light of earlier decision taken in meeting no. 03/82 dated 08.05.2014, it was decided to ratify norms under Para 4.07 of HBP v1 as per details given below or as applied by the firm, whichever is less:

87

Export product Exp. Qty. Sl.No. Import items Qty. allowed (kg) Lumefantrine 1 kg 1. 2, 7-DICHLORO - A - (DIBUTYLAMINO) METHYL-9H-FLUORENE-4- METHANOL (DBA) 0.8691
2. 4 - CHLOROBENZALDEHYDE 0.3476

362

Case No.:447/5/82-ALC4/2015 Party Name:AARTI

INDUSTRIES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00587/AM16/
RLA File :03/94/040/01131/AM15/
Lic.No/Date:0310794543 12.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

363

Case No.:412/5/82-ALC4/2015 Party Name:BDR

PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00552/AM16/
RLA File :03/94/040/00983/AM15/
Lic.No/Date:0310794539 12.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

364

Case No.:301/5/82-ALC4/2015 Party Name:CADILA

HEALTHCARE LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00441/AM16/
RLA File :08/24/040/00460/AM15/
Lic.No/Date:0810134780 12.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

365

Case No.:305/5/82-ALC4/2015 Party Name:DHANUKA

LABORATORIES LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00445/AM16/
RLA File :05/23/040/00555/AM15/
Lic.No/Date:0510393548 12.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

366

Case No.:446/5/82-ALC4/2015 Party Name:ELPPE

CHEMICALS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved

88

HQ File :01/82/050/00586/AM16/
RLA File :03/94/040/01144/AM15/
Lic.No/Date:0310794542 12.03.2015

Department of Pharmaceuticals vide O.M.No35011/84 /2014-PI (Norms) dt. October, 2014 as Export product Qty. Import items Qty.kg/kg PHENYL THIO PROLINE 1kg TRANS-4-HYDROXY-L- PROLINE 1.574 ISOBUTYL ACETATE 4.56 METHANE SULFONYL CHLORIDE 1.68 THIO PHENOL 0.839

367

Case No.:413/5/82-

ALC4/2015
Party Name:INDO AMINES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00553/AM16/
RLA File :03/94/040/01145/AM15/
Lic.No/Date:0310794545 12.03.2015 Defer Date 16.09.2015 O.M.No.14010/81/2010-CH-II dated 23rd July 2015 decided to call for following 3. Basis of applied quantity of import with complete material balance at each stage of manufacturing process. 4. Any other relevant information, if any.

368

Case No.:34/5/82-ALC4/2015 Party Name:ASCENT

FINECHEM PVT. LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00174/AM16/
RLA File :08/24/040/00397/AM15/
Lic.No/Date:0810134800 13.03.2015 Defer Date 16.09.2015 O.M.No.14010/1/2012-CH-II dated 27th July 2015 decided to call for following

89

  1. Complete material balance indicating input and output material on weight to weight basis at each stage of manufacturing process.
  2. Details of by products formed during the process and the recovery of solvents in
  3. Details of production of export product under reference and corresponding
  4. Any other relevant information, if any.

369

Case No.:321/5/82-ALC4/2015 Party Name:R L FINE CHEM

Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00461/AM16/
RLA File :07/24/040/00411/AM15/
Lic.No/Date:0710107823 13.03.2015

Department of Pharmaceuticals vide O.M.No35011/677 /2012-PI (Norms) dt. 12th March 2015 Export product Qty. Import items Qty.kg/kg Nortriptyline Hcl 1kg 1,Bromo 3 Chloro propane 0.96 Tetra Hydro Furan 0.71 Ethyl Chloro formate 0.46

370

Case No.:322/5/82-ALC4/2015 Party Name:R L FINE CHEM

Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00462/AM16/
RLA File :07/24/040/00414/AM15/
Lic.No/Date:0710107818 13.03.2015

Department of Pharmaceuticals vide O.M.No35011/599 /2014-PI (Norms) dt. April 2015 as Export product Qty. Import items Qty.kg/kg Doxilamine Succinate 1kg 2-Acetyl Pyridine 0.58 Tetrahydrofuran 1.03

371

Case No.:425/5/82-ALC4/2015 Party Name:BENZO CHEM

INDUSTRIES PRIVATE LIMITED, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File RLA File Lic.No/Date:0310794611 Defer Date

90

:01/82/050/00565/AM16/
:03/94/040/01126/AM15/
16.03.2015 16.09.2015 Chemicals.

372

Case No.:33/5/82-ALC4/2015 Party Name:CADILA

HEALTHCARE LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00173/AM16/
RLA File :08/24/040/00466/AM15/
Lic.No/Date:0810134816 16.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

373

Case No.:421/5/82-ALC4/2015 Party Name:INDOCO

REMEDIES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00561/AM16/
RLA File :03/94/040/01151/AM15/
Lic.No/Date:0310794615 16.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

374

Case No.:409/5/82-ALC4/2015 Party Name:NOCIL LIMITED Meet No/Date:5/82-

ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00549/AM16/
RLA File :03/95/040/00974/AM15/
Lic.No/Date:0310794587 16.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

375

Case No.:8/5/82-ALC4/2015

Party Name:RA CHEM PHARMA LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00148/AM16/
RLA File :09/24/040/00692/AM15/
Lic.No/Date:0910061705 16.03.2015

Decision : The committee decided to ratify the norms as per SION A-412 or as applied by the firm whichever is less.

376

Case No.:302/5/82-ALC4/2015 Party Name:STERILE INDIA

PRIVATE LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00442/AM16/
RLA File :05/24/040/00589/AM15/
Lic.No/Date:0510393585 16.03.2015 Defer Date 16.09.2015

91

Decision : The Committee in light of written comments of D/o Pharmaceuticals O.M. No.35011/178/2014-PI (Norms) dated October, 2014 decided to call for following information from the firm:- a. Complete description of export product showing ratio of Piperacillin and Tazobactam in the export product. b. Copy of DML for the above composition c. Complete technical details as per Apendix-33.

377

Case No.:9/5/82-ALC4/2015

Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00149/AM16/
RLA File :09/24/040/00671/AM15/
Lic.No/Date:0910061707 16.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

378

Case No.:43/5/82-ALC4/2015 Party Name:SUVEN LIFE

SCIENCES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00183/AM16/
RLA File :09/24/040/00694/AM15/
Lic.No/Date:0910061706 16.03.2015

Department of Pharmaceuticals vide O.M.No35011/ 761 /2013-PI (Norms) dt. 4th March 2014 Export product Qty. Import items Qty.kg/kg Gabapentin 1kg Cyclohexane-1,1-Diacetic Acid Monoamide (CDAM) 1.63 Acetone 1.541

379

Case No.:429/5/82-ALC4/2015 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00569/AM16/
RLA File :03/95/040/01056/AM15/
Lic.No/Date:0310794585 16.03.2015 Defer Date 16.09.2015 Chemicals.

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

92

LIMITED(FORMERLY KNOWN HIGH POLYMER ALC4/2015 25.06.2015 HQ File :01/82/050/00429/AM16/
RLA File :05/23/040/00560/AM15/
Lic.No/Date:0510393593 17.03.2015 Defer Date 16.09.2015 Chemicals.

381

Case No.:44/5/82-ALC4/2015 Party Name:SRIAM LABS

PRIVATE LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00184/AM16/
RLA File :09/24/040/00666/AM15/
Lic.No/Date:0910061718 17.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

382

Case No.:291/5/82-ALC4/2015 Party Name:JUBILANT LIFE

SCIENCES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00431/AM16/
RLA File :05/23/040/00544/AM15/
Lic.No/Date:0510393616 18.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

383

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

ETHICALS PVT LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00566/AM16/
RLA File :03/94/040/01162/AM15/
Lic.No/Date:0310794710 19.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

384

Case No.:420/5/82-ALC4/2015 Party Name:KUSUMA

PHARMA Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00560/AM16/
RLA File :03/94/040/01175/AM15/
Lic.No/Date:0310794718 19.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

385

Case No.:156/5/82-ALC4/2015 Party Name:MALLADI

DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred

93

HQ File :01/82/050/00296/AM16/
RLA File :04/24/040/00266/AM15/
Lic.No/Date:0410160309 19.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

386

Case No.:192/5/82-ALC4/2015 Party Name:MALLADI

DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00332/AM16/
RLA File :04/24/040/00009/AM15/
Lic.No/Date:0410160310 19.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

387

Case No.:292/5/82-ALC4/2015 Party Name:MOREPEN

LABORATORIES LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00432/AM16/
RLA File :05/24/040/00598/AM15/
Lic.No/Date:0510393647 19.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

388

Case No.:311/5/82-ALC4/2015 Party Name:MOREPEN

LABORATORIES LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00451/AM16/
RLA File :05/24/040/00597/AM15/
Lic.No/Date:0510393646 19.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

389

Case No.:315/5/82-ALC4/2015 Party Name:ACEBRIGHT

(INDIA) PHARMA PVT LTD, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00455/AM16/
RLA File :07/24/040/00461/AM15/
Lic.No/Date:0710107895 20.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

390

Case No.:25/5/82-ALC4/2015 Party Name:SHREE JAYA

LABORATORIES PVT LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00165/AM16/
RLA File :09/24/040/00695/AM15/
Lic.No/Date:0910061734 20.03.2015

94

Department of Pharmaceuticals vide O.M.No. 35011/581 /2014-PI (Norms) dt. May, 2015 as per Export product Qty. Import items Qty.kg/kg

  • 2-CHLOROMETHYL- 4-METHOXY-3, 5- DIMETHYLPYRIDINE HCL 1kg 1 3,5 Lutidine 1.04 2 Hydrogen peroxide 1.13 3 Chloroform 5.20 4 Ammonium per Sulphate 1.80 5 Thionyl Chloride 0.80

391

Case No.:403/5/82-ALC4/2015 Party Name:WANBURY

LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00543/AM16/
RLA File :03/95/040/00921/AM15/
Lic.No/Date:0310794737 20.03.2015

Department of Pharmaceuticals vide O.M.No. 35011/710 /2014-PI (Norms) dt. February 2015 Export product Qty. Import items Qty.kg/kg Sertraline Hydrochloride 1kg 1 Methanol 3.78 2 Isopropyl Alcohol 0.75 3 D Mandelic Acid 0.392 4 Tetraloneimine 3.27 5 n-Hexane 0.47

392

Case No.:404/5/82-ALC4/2015 Party Name:WANBURY

LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00544/AM16/
RLA File :03/95/040/00944/AM15/
Lic.No/Date:0310794730 20.03.2015

Decision:The committee decided to ratify the norms based on the recommendation of Department of Pharmaceuticals vide O.M.No. 35011/805/2014-PI (Norms) dt. June, 2015 as Export product Qty. Import items Qty.kg/kg Metformin Hcl 1kg 1 Dicyanodimide 0.567 2 DMA Hcl (Di- Methylamine Hydrochloride) 0.60 3 Methanol 0.237 4 (PACKING MATERIAL) HDPE DRUM / FBER As per packing

95

DRUM ) policy 5 (PACKING MATERIAL) INNER POLYTHIN ) BAGS ( 32 X 50 / 24 X 36
As per packing policy

393

Case No.:407/5/82-ALC4/2015 Party Name:WANBURY

LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00547/AM16/
RLA File :03/95/040/00934/AM15/
Lic.No/Date:0310794735 20.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

394

Case No.:417/5/82-ALC4/2015 Party Name:WANBURY

LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00557/AM16/
RLA File :03/95/040/00919/AM15/
Lic.No/Date:0310794738 20.03.2015

Department of Pharmaceuticals vide O.M.No. 35011/35 /2014-PI (Norms) dt. February, 2015 Export product Qty. Import items Qty.
PAROXETINE HYDROCHLORIDE EP 1kg 1 (3S,4R(-4- FLUOROPHENYL)-3- HYDROXYMETHYL-1- METHYLPIPERDINE(S- CARBOINOL) 0.810 kg /kg 2 TOSYL CHLORIDE 0.98 kg /kg 3 TRIETHYLAMINE 0.68 kg /kg 4 DIMETHYL AMINO PYRIDINE 0.017 kg /kg 5 DICHLOROMETHANE 7.95 lit./kg 6 SESAMOL 0.55 kg/kg 7 TOLUENE 4.65 lit./kg 8 PHENYL CHLOFORMATE 0.64 lit/kg 9 METHANOL 0.40 lit/kg

395

Case No.:430/5/82-ALC4/2015 Party Name:WANBURY

LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00570/AM16/
RLA File :03/95/040/00933/AM15/
Lic.No/Date:0310794741 20.03.2015

96

Department of Pharmaceuticals vide O.M.No. 35011/805/2014-PI (Norms) dt. June, 2015 as Export product Qty. Import items Qty.kg/kg Metformin Hcl 1kg 1 Dicyanodimide 0.567 2 DMA Hcl (Di- Methylamine Hydrochloride) 0.60 3 Methanol 0.237 4 (PACKING MATERIAL) HDPE DRUM / FBER DRUM ) As per packing policy 5 (PACKING MATERIAL) INNER POLYTHIN ) BAGS ( 32 X 50 / 24 X 36
As per packing policy

396

Case No.:433/5/82-ALC4/2015 Party Name:WANBURY

LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00573/AM16/
RLA File :03/95/040/00918/AM15/
Lic.No/Date:0310794728 20.03.2015

Department of Pharmaceuticals vide O.M. No. 35011/704 /2013-PI (Norms) dt. January, 2015 Export product Qty. Import items Qty.
Tramadol HYDROCHLORIDE
1kg 1 Cyclohexanone 1.00kg 2 N, Bromo Anisole 1.93kg 3 Tetrahydrofuran 1.57kg 4 Isopropyl Alcohol 1.18kg 5 n-Hexane 0.58kg 6 Paraformaldehyde 0.29kg 7 TOLUENE 0.51kg 8 Methanol 1.66kg
9 Dimethylamine Hcl 0.81 10 (PACKING MATERIAL ) HDPE DRUM/FIBER DRUM
As per packing policy 11 (PACKING MATERIAL) INNER POLYTHIN BAGS (32 X 50 / 24 X 36)
As per packing policy

397

Case No.:436/5/82-ALC4/2015 Party Name:WANBURY

LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00576/AM16/
RLA File :03/95/040/00945/AM15/
Lic.No/Date:0310794733 20.03.2015

97

Department of Pharmaceuticals vide O.M.No. 35011/805/2014-PI (Norms) dt. June, 2015 as Export product Qty. Import items Qty.kg/kg Metformin Hcl 1kg 1 Dicyanodimide 0.567 2 DMA Hcl (Di- Methylamine Hydrochloride) 0.60 3 Methanol 0.237 4 (PACKING MATERIAL) HDPE DRUM / FBER DRUM ) As per packing policy 5 (PACKING MATERIAL) INNER POLYTHIN ) BAGS ( 32 X 50 / 24 X 36
As per packing policy

398

Case No.:439/5/82-ALC4/2015 Party Name:WANBURY

LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00579/AM16/
RLA File :03/95/040/00936/AM15/
Lic.No/Date:0310794739 20.03.2015

Department of Pharmaceuticals vide O.M.No. 35011/805/2014-PI (Norms) dt. June, 2015 as Export product Qty. Import items Qty.kg/kg Metformin Hcl 1kg 1 Dicyanodimide 0.567 2 DMA Hcl (Di- Methylamine Hydrochloride) 0.60 3 Methanol 0.237 4 (PACKING MATERIAL) HDPE DRUM / FBER DRUM ) As per packing policy 5 (PACKING MATERIAL) INNER POLYTHIN ) BAGS ( 32 X 50 / 24 X 36
As per packing policy

399

Case No.:440/5/82-ALC4/2015 Party Name:WANBURY

LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00580/AM16/
RLA File :03/95/040/00923/AM15/
Lic.No/Date:0310794731 20.03.2015

Decision : : The committee decided to ratify the norms based on the recommendation of Department of Pharmaceuticals vide O.M. No. 35011/704 /2013-PI (Norms) dt. January, 2015

98

Export product Qty. Import items Qty.
Tramadol HYDROCHLORIDE
1kg 1 Cyclohexanone 1.00kg 2 N, Bromo Anisole 1.93kg 3 Tetrahydrofuran 1.57kg 4 Isopropyl Alcohol 1.18kg 5 n-Hexane 0.58kg 6 Paraformaldehyde 0.29kg 7 TOLUENE 0.51kg 8 Methanol 1.66kg
9 Dimethylamine Hcl 0.81 10 (PACKING MATERIAL ) HDPE DRUM/FIBER DRUM
As per packing policy 11 (PACKING MATERIAL) INNER POLYTHIN BAGS (32 X 50 / 24 X 36)
As per packing policy

400

Case No.:441/5/82-ALC4/2015 Party Name:WANBURY

LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00581/AM16/
RLA File :03/95/040/00924/AM15/
Lic.No/Date:0310794736 20.03.2015

Decision : : The committee decided to ratify the norms based on the recommendation of Department of Pharmaceuticals vide O.M. No. 35011/704 /2013-PI (Norms) dt. January, 2015 Export product Qty. Import items Qty.
Tramadol HYDROCHLORIDE
1kg 1 Cyclohexanone 1.00kg 2 N, Bromo Anisole 1.93kg 3 Tetrahydrofuran 1.57kg 4 Isopropyl Alcohol 1.18kg 5 n-Hexane 0.58kg 6 Paraformaldehyde 0.29kg 7 TOLUENE 0.51kg 8 Methanol 1.66kg
9 Dimethylamine Hcl 0.81 10 (PACKING MATERIAL ) HDPE DRUM/FIBER DRUM
As per packing policy 11 (PACKING MATERIAL) INNER POLYTHIN BAGS (32 X 50 / 24 X 36)
As per packing policy

99

401

Case No.:442/5/82-ALC4/2015 Party Name:WANBURY

LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00582/AM16/
RLA File :03/95/040/00922/AM15/
Lic.No/Date:0310794732 20.03.2015

Department of Pharmaceuticals vide O.M.No. 35011/705 /2014-PI (Norms) dt. February, 2015 Export product Qty. Import items Qty.kg/kg Mefenamic Acid 1kg 1 Orthochloro Benzoic Acid 1.053 2 2,3-Xylidine 0.806 3 Isoprpyl Alcohol 1.763 4 Methanol Not shown in the process

402

Case No.:443/5/82-ALC4/2015 Party Name:WANBURY

LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00583/AM16/
RLA File :03/95/040/00920/AM15/
Lic.No/Date:0310794742 20.03.2015

Decision: The committee decided to ratify the norms based on the recommendation of Department of Pharmaceuticals vide O.M.No. 35011/706/2013-PI (Norms) dt. January, 2015 Export product Qty. Import items Qty.kg/kg Diphenhydramine Hcl 1kg 1 Bromine 0.57 2 Dimethyl Amino Ethanol 0.527 3 Isopropyl alchohol 1.00 4 Mono Chloro Benzene 0.58 5 Diphenylemethane 0.997

403

Case No.:266/5/82-ALC4/2015 Party Name:GOPINATH

CHEM-TECH LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00406/AM16/
RLA File :08/24/040/00479/AM15/
Lic.No/Date:0810134881 23.03.2015

Department of C&PC vide U.O.No.114010/22/2015/CH-II dated 9.7.2015 as per details given below or as applied by the firm whichever is less:-
Export product Qty. Import items Qty.kg/kg Coper formazone base 1kg 1 Ortho Amino Phenol 0.614 2 Toluene 2.205 3 Caustic Soda Lye (on 7.200

100

100% Real Basis) 4 Soda Ash 2.700 5 Sodium Nitrite 0.750

404

Case No.:408/5/82-ALC4/2015 Party Name:SHIRDI

CHEMICALS PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00548/AM16/
RLA File :03/95/040/01059/AM15/
Lic.No/Date:0310794798 23.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

405

Case No.:183/5/82-ALC4/2015 Party Name:SPAK

ORGOCHEM (INDIA) PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00323/AM16/
RLA File :03/95/040/00964/AM15/
Lic.No/Date:0310794811 23.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

406

Case No.:428/5/82-ALC4/2015 Party Name:WANBURY

LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00568/AM16/
RLA File :03/95/040/00935/AM15/
Lic.No/Date:0310794795 23.03.2015

Department of Pharmaceuticals vide O.M.No. 35011/805/2014-PI (Norms) dt. June, 2015 as Export product Qty. Import items Qty.kg/kg Metformin Hcl 1kg 1 Dicyanodimide 0.567 2 DMA Hcl (Di- Methylamine Hydrochloride) 0.60 3 Methanol 0.237 4 (PACKING MATERIAL) HDPE DRUM / FBER DRUM ) As per packing policy 5 (PACKING MATERIAL) INNER POLYTHIN ) BAGS ( 32 X 50 / 24 X 36
As per packing policy

407 Case No.:310/5/82-ALC4/2015 Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:5/82- ALC4/2015 Deferred

101

25.06.2015 HQ File :01/82/050/00450/AM16/
RLA File :05/23/040/00562/AM15/
Lic.No/Date:0510393721 24.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

408

Case No.:410/5/82-ALC4/2015 Party Name:INDO AMINES

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00550/AM16/
RLA File :03/94/040/01184/AM15/
Lic.No/Date:0310794835 24.03.2015 Defer Date 16.09.2015 O.M.No.14010/81/2010-CH-II dated 23rd July 2015 decided to call for following 3. Basis of applied quantity of import with complete material balance at each stage of manufacturing process 4. You have indicated details of production during the last years as nil. The details of production of export product under reference and corresponding consumption of raw material in the year 2015-16 (April to till date) duly certified by CA.

409

Case No.:191/5/82-ALC4/2015 Party Name:MALLADI

DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00331/AM16/
RLA File :04/24/040/00309/AM15/
Lic.No/Date:0410160331 24.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

410

Case No.:193/5/82-ALC4/2015 Party Name:MALLADI

DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00333/AM16/
RLA File :04/24/040/00310/AM15/
Lic.No/Date:0410160332 24.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

102

411

Case No.:178/5/82-ALC4/2015 Party Name:WINTAC

LIMITED, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00318/AM16/
RLA File :07/24/040/00437/AM15/
Lic.No/Date:0710107914 24.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

412

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

DYESTUFF PVT. LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00169/AM16/
RLA File :08/24/040/00483/AM15/
Lic.No/Date:0810134917 25.03.2015 Defer Date 16.09.2015 Chemicals.

413

Case No.:427/5/82-ALC4/2015 Party Name:SHALINA

LABORATORIES PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00567/AM16/
RLA File :03/95/040/01071/AM15/
Lic.No/Date:0310794916 26.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

414

Case No.:431/5/82-ALC4/2015 Party Name:EUROLIFE

HEALTHCARE PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00571/AM16/
RLA File :03/94/040/01086/AM15/
Lic.No/Date:0310794964 27.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

415

Case No.:448/5/82-ALC4/2015 Party Name:AARTI

INDUSTRIES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00588/AM16/
RLA File :03/94/040/01211/AM15/
Lic.No/Date:0310795048 31.03.2015 Defer Date 16.09.2015 Chemicals.

416

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

SCIENCES LIMITED. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred

103

HQ File :01/82/050/00156/AM16/
RLA File :09/24/040/00736/AM15/
Lic.No/Date:0910061856 31.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

417

Case No.:405/5/82-ALC4/2015 Party Name:CTX

LIFESCIENCES PVT LTD, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00545/AM16/
RLA File :03/94/040/00521/AM15/
Lic.No/Date:0310795052 31.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

418

Case No.:438/5/82-ALC4/2015 Party Name:ENCUBE

ETHICALS PVT LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00578/AM16/
RLA File :03/94/040/01196/AM15/
Lic.No/Date:0310795049 31.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

419

Case No.:19/5/82-ALC4/2015 Party Name:MAHARSHI

PHARMA CHEM PVT.LTD, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00159/AM16/
RLA File :08/24/040/00485/AM15/
Lic.No/Date:0810134977 31.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

420

Case No.:27/5/82-ALC4/2015 Party Name:POSY

PHARMACHEM PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00167/AM16/
RLA File :08/24/040/00449/AM15/
Lic.No/Date:0810134978 31.03.2015 Defer Date 16.09.2015 Decision : The committee in light of the written comment of D/o Pharmaceuticals forwarded vide O.I.No.35011/609/2014-PI(Norms) dated April 2015 decided to call for following information from the firm:-

  1. COA of export product
  2. COA of import item from Foreign supplier.

421

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

INDUSTRIES LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File RLA File Lic.No/Date:5610004573 Defer Date

104

:01/82/050/00168/AM16/
:56/24/040/00064/AM15/
31.03.2015 16.09.2015 Decision : The Committee in light of written comments of D/o C&PC letter No.14010/31/2015-CH-II dated 15.7.2015 decided to call for following information from the firm:-

  1. Comparative Technical specifications of Soya Lecithin Liquid (Food Grade) and Crude soya lecithin and copy of export order/proforma invoice of import product may be furnished.
  2. Detailed manufacturing process along with technical justification for wastages on each of the raw materials and each stage of manufacturing process.
  3. Material balance on weight to weight basis at each stage of manufacturing process.
  4. Details of production of export product under reference and corresponding consumption of war material in the year 2013-14, 2014-15 and 2015-16 (April to June duly certified by CA.

422

Case No.:24/5/82-ALC4/2015 Party Name:SATYADEVA

PHARMACEUTICALS /P/ LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00164/AM16/
RLA File :09/24/040/00729/AM15/
Lic.No/Date:0910061845 31.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

423

Case No.:40/5/82-ALC4/2015 Party Name:VASUDHA

PHARMA CHEM LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00180/AM16/
RLA File :09/24/040/00691/AM15/
Lic.No/Date:0910061852 31.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

424

Case No.:12/5/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00152/AM16/
RLA File :09/24/040/00627/AM15/
Lic.No/Date:0910061822 31.03.2015 Defer Date 16.09.2015 Pharmaceuticals.

425

Case No.:46/5/82-ALC4/2015 Party Name:JUBILANT LIFE

SCIENCES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 approved HQ File :01/82/050/00186/AM16/
RLA File :05/23/040/00594/AM15/
Lic.No/Date:0510393819 01.04.2015

105

Department of Pharmaceuticals vide O.M.No35011/ 552 /2012-PI (Norms) dt. 27.12 2012 as per Export product Qty. Import items Qty.kg/kg Azacyclonol 1kg 1 THF 2.81 2 Gamma Picoline 0.74 3 Magnesium Turning 0.30 4 Toluene 0.405 5 Monochloro Benzene 1.40 6 Methanol
0.375

426

Case No.:432/5/82-ALC4/2015 Party Name:AVA

CHEMICALS PVT.LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00572/AM16/
RLA File :03/94/040/01212/AM15/
Lic.No/Date:0310795110 06.04.2015 Defer Date 16.09.2015 Chemicals.

427

Case No.:418/5/82-ALC4/2015 Party Name:FDC LTD

Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00558/AM16/
RLA File :03/94/040/01109/AM15/
Lic.No/Date:0310795101 06.04.2015

Department of Pharmaceuticals vide O.M.No35011/643 /2012-PI (Norms) dt. 12.3. 2015 as per Export product Import items Qty. Brimonidine Eye Drops 5ml. Brimonidine L-Tartrate 0.0102gm/vial

428

Case No.:419/5/82-ALC4/2015 Party Name:FDC LTD

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00559/AM16/
RLA File :03/94/040/01173/AM15/
Lic.No/Date:0310795100 06.04.2015 Defer Date 16.09.2015 Pharmaceuticals.

429 Case No.:449/5/82-ALC4/2015 Party Name:INDOFIL Meet No/Date:5/82- Deferred

106

INDUSTRIES LTD. ALC4/2015 25.06.2015 HQ File :01/82/050/00589/AM16/
RLA File :03/94/040/01208/AM15/
Lic.No/Date:0310795116 06.04.2015 Defer Date 16.09.2015 Chemicals.

430

Case No.:416/5/82-ALC4/2015 Party Name:BLUE CIRCLE

ORGANICS PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00556/AM16/
RLA File :03/94/040/01197/AM15/
Lic.No/Date:0310795139 07.04.2015 Defer Date 16.09.2015 Decision : : The committee in light of the written comment of D/o C&PC forwarded vide O.M.No.14010/21/2013-CH-II dated 31st July 2015 decided to call for following 3. Details of by products formed during the process and the recovery of solvents in 4. Details of production of export product under reference and corresponding consumption of raw material in the year 2014-15 duly certified by CA.

431

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

CHEMICALS Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00166/AM16/
RLA File :08/24/040/00470/AM15/
Lic.No/Date:0810134992 07.04.2015 Defer Date 16.09.2015 Decision : In the light of written comments received from D/o C&CP letter No.14010/15/2013- Ch-II dt. July.2015, it was decided to call for information from the firm:-

  1. Details of production of export product under reference in 2014-15 and corresponding consumption of raw materials duly certified by CA.
  2. Any other relevant information, if any.

432

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

LABORATORIES PVT. LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00551/AM16/
RLA File :03/95/040/01033/AM15/
Lic.No/Date:0310795186 08.04.2015 Defer Date 16.09.2015

107

Pharmaceuticals.

433

Case No.:424/5/82-ALC4/2015 Party Name:UNICHEM

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00564/AM16/
RLA File :03/95/040/01083/AM15/
Lic.No/Date:0310795220 09.04.2015 Defer Date 16.09.2015 Pharmaceuticals.

434

Case No.:406/5/82-ALC4/2015 Party Name:ENCUBE

ETHICALS PVT LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00546/AM16/
RLA File :03/94/040/01225/AM15/
Lic.No/Date:0310795279 13.04.2015 Defer Date 16.09.2015 Pharmaceuticals.

435

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

Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00145/AM16/
RLA File :08/24/040/00003/AM16/
Lic.No/Date:0810135051 17.04.2015 Defer Date 16.09.2015 Pharmaceuticals.

436

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

Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00146/AM16/
RLA File :08/24/040/00004/AM16/
Lic.No/Date:0810135050 17.04.2015 Defer Date 16.09.2015 Pharmaceuticals.

437

Case No.:10/5/82-ALC4/2015 Party Name:PI INDUSTRIES

LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00150/AM16/
RLA File :13/24/040/00056/AM15/
Lic.No/Date:1310047840 17.04.2015 Defer Date 16.09.2015 Chemicals.

108

438

Case No.:175/5/82-ALC4/2015 Party Name:STERICON

PHARMA PVT.LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00315/AM16/
RLA File :07/24/040/00010/AM16/
Lic.No/Date:0710108077 17.04.2015

Decision : Committee considered the case as per agenda and in light of earlier decision taken by NC in its meeting No.09/82/2014 dated 20.10.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Sl. No.
Export Product

Import Items SOFT BOTTLE WHITE CAP DROPPER SODIUM HYALURONATE NaF100 1 VIZULIZE MOISTURIZING AND COMFORT EYE DROPS 0.1% -10ML Relevant as per packing policy 0.01 gm per bottle 2 VIZULIZE LUBRICATING AND REWETTING EYE DROPS 15ML -Do- NIL

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

439

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

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00175/AM16/
RLA File :09/24/040/00739/AM15/
Lic.No/Date:0910061891 17.04.2015 Defer Date 16.09.2015 Pharmaceuticals.

440

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

PHARMACEUTICALS LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00172/AM16/
RLA File :09/24/040/00011/AM16/
Lic.No/Date:0910061900 20.04.2015 Defer Date 16.09.2015 Pharmaceuticals.

441

Case No.:22/5/82-ALC4/2015 Party Name:KLJ

PLASTICIZERS LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00162/AM16/
RLA File :05/23/040/00587/AM15/
Lic.No/Date:0510393920 23.04.2015 Defer Date 16.09.2015

109

Chemicals.

442

Case No.:36/5/82-ALC4/2015 Party Name:KLJ

PLASTICIZERS LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00176/AM16/
RLA File :05/23/040/00597/AM15/
Lic.No/Date:0510393894 23.04.2015 Defer Date 16.09.2015 Chemicals.

443

Case No.:187/5/82-ALC4/2015 Party Name:VASUDHA

PHARMA CHEM LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00327/AM16/
RLA File :09/24/040/00033/AM16/
Lic.No/Date:0910061926 24.04.2015

Department of Pharmaceuticals vide O.M.No35011/ 798 /2013-PI (Norms) dt. September 2014 as per details given below or as applied by the firm whichever is less:-
Export product Qty. Import items Qty.kg/kg 2-BUTYL-4-FORMYL IMIDAZOLE (OR) 2- BUTYL-1H-IMIDAZOLE-5- CARBOXALDEHYDE 1kg 2(N-BUTYL)-4-CHLORO-5- FORMYL IMIDAZOLE 1.45

Methanol 0.96 Methylene Dichloride 0.83 Activated carbon 0.05

444

Case No.:17/5/82-ALC4/2015 Party Name:SUN

PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00157/AM16/
RLA File :05/24/040/00030/AM16/
Lic.No/Date:0510394006 28.04.2015 Defer Date 16.09.2015 Pharmaceuticals.

445

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

PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00158/AM16/
RLA File :04/24/040/00011/AM16/
Lic.No/Date:0410160467 30.04.2015

Department of Pharmaceuticals vide O.M.No35011/ 15 /2015-PI (Norms) dt. 22nd July, 2015 as

110

Export product Qty. Import items Qty.kg/kg METOPROLOL TARTRATE TABLETS USP 25 MG 1 tablet METOPROLOL TARTRATE 25.50mg Magnesium Stearate 1.49mg Micro Crystalline Cellulose
75.21mg Croscarmellose Sodium 11.92mg Closure As per packing policy Plastic Bottles As per packin g policy

446

Case No.:174/5/82-ALC4/2015 Party Name:GLOBAL

CALCIUM PRIVATE LIMITED, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00314/AM16/
RLA File :07/24/040/00393/AM15/
Lic.No/Date:0710108142 01.05.2015 Defer Date 16.09.2015 Chemicals.

447

Case No.:176/5/82-ALC4/2015 Party Name:GLOBAL

CALCIUM PRIVATE LIMITED, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00316/AM16/
RLA File :07/24/040/00389/AM15/
Lic.No/Date:0710108141 01.05.2015 Defer Date 16.09.2015 Chemicals.

448

Case No.:177/5/82-ALC4/2015 Party Name:GLOBAL

CALCIUM PRIVATE LIMITED, Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00317/AM16/
RLA File :07/24/040/00390/AM15/
Lic.No/Date:0710108143 01.05.2015 Defer Date 16.09.2015 Chemicals.

449

Case No.:188/5/82-ALC4/2015 Party Name:VASUDHA

PHARMA CHEM LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00328/AM16/
RLA File :09/24/040/00004/AM16/
Lic.No/Date:0910061956 01.05.2015

111

Department of Pharmaceuticals vide O.M.No35011/ 23/2013-PI (Norms) dt 1.4.2013 as Export product Qty. Import items Qty.kg/kg Losartan Potassium 1kg 1 Methanol 0.713 2 Toluene 0.623 3 Sodium Azide 0.35 4 2(N-BUTYL)-4- CHLORO-5- FORMYL IMIDAZOLE 0.50 5 2-CYANO-4- BROMOMETHYL BIPHENYL
0.80 6 Iso propyl alcohol 0.964 7 Sodium Borohydride 0.048 8 Activated carbon
0.100

450

Case No.:21/5/82-ALC4/2015 Party Name:DHANUKA

LABORATORIES LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00161/AM16/
RLA File :05/23/040/00003/AM16/
Lic.No/Date:0510394100 05.05.2015 Defer Date 16.09.2015 Pharmaceuticals.

451

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

LABORATORIES LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00160/AM16/
RLA File :05/24/040/00040/AM16/
Lic.No/Date:0510394095 05.05.2015 Defer Date 16.09.2015 Pharmaceuticals.

452

Case No.:37/5/82-ALC4/2015 Party Name:MOREPEN

LABORATORIES LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00177/AM16/
RLA File :05/24/040/00039/AM16/
Lic.No/Date:0510394094 05.05.2015 Defer Date 16.09.2015

112

Pharmaceuticals.

453

Case No.:23/5/82-ALC4/2015 Party Name:SOHAN

HEALTHCARE PVT. LTD Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00163/AM16/
RLA File :31/83/040/00250/AM15/
Lic.No/Date:3110065410 05.05.2015

Department of Pharmaceuticals vide O.M.No35011/346 /2013-PI (Norms) dt. 30.7. 2015 as per Export product Qty. Import items Qty.kg/kg Metformin Hydrochloride BP/EP/USP 1kg Dicyandiamide 0.567 Di Methyl Amine Hcl 0.60 Mix Zylene 0.027 methanol 0.237

454

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

Party Name:S.M. HERBALS PVT.LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00143/AM16/
RLA File :05/24/040/00014/AM16/
Lic.No/Date:0510394126 07.05.2015 Defer Date 16.09.2015 Decision : In the light of written comments received from D/o Pharmaceuticals vide their OM No35011/388/2013-PI(Norms) dt.26.9.2013, it was decided to call for information from the firm:-

  1. COA from foreign Supplier for relevant import consignments for the imported input.
  2. COA from independent & Approval Testing laboratory for export product
  3. Stepwise process with wastage envisaged in the process.

455

Case No.:4/5/82-ALC4/2015

Party Name:S.M. HERBALS PVT.LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00144/AM16/
RLA File :05/24/040/00034/AM16/
Lic.No/Date:0510394128 07.05.2015

Department of Pharmaceuticals vide O.M.No35011/ 347 /2013-PI (Norms) dt. 11.9. 2013 as per Export product Qty. Import items Qty.kg/kg Quinoline Based Alkaloid-Camptothecin (Chemical) HPLC Purity Not Less Than 98.5% 1kg Camptothecin (HPLC NLT 90% and NMT 96.8%) 1.0346

113

456

Case No.:7/5/82-ALC4/2015

Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00147/AM16/
RLA File :05/23/040/00037/AM16/
Lic.No/Date:0510394177 08.05.2015 Defer Date 16.09.2015 Pharmaceuticals.

457

Case No.:2/5/82-ALC4/2015

Party Name:UNITED BIOTECH PVT.LTD. Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00142/AM16/
RLA File :05/24/040/00009/AM16/
Lic.No/Date:0510394187 11.05.2015 Defer Date 16.09.2015 Pharmaceuticals.

458

Case No.:1/5/82-ALC4/2015

Party Name:KLJ PLASTICIZERS LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00141/AM16/
RLA File :05/23/040/00039/AM16/
Lic.No/Date:0510394196 12.05.2015

Department of C&PC U.O.No.14010/36/2011 Ch-II dt. 8.3. 2015 as per details given below or as applied by the firm whichever is less:-
Export product Qty. Import items Qty.kg/kg Kanatol-400 (N) 1kg Phthalic Andydride 0.560 Normal Butanol 0.550

459

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

PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00339/AM16/
RLA File :04/24/040/00040/AM16/
Lic.No/Date:0410160570 21.05.2015 Defer Date 16.09.2015 Pharmaceuticals.

460

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

PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred

114

HQ File :01/82/050/00340/AM16/
RLA File :04/24/040/00038/AM16/
Lic.No/Date:0410160569 21.05.2015 Defer Date 16.09.2015 Pharmaceuticals.

461

Case No.:184/5/82-ALC4/2015 Party Name:ZENITH

DYEINTERMEDIATES LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Approved HQ File :01/82/050/00324/AM16/
RLA File :03/95/040/00181/AM16/
Lic.No/Date:0310796621 15.06.2015

Decision : In the light of decision taken by NC in its meeting No.03/82/2013 dated 02.05.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed NAS-5 (2-Diazo- 1-Napthol-5 Sulfonic Acid, Sodium Salt 1 kg 1. Tobias Acid 97% Min.

Or
1.618 kg

Sulfo Tobias (Purity 65% min on 100% basis) 1.798 kg

462

Case No.:185/5/82-ALC4/2015 Party Name:HETERO LABS

LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00325/AM16/
RLA File :09/24/040/00161/AM16/
Lic.No/Date:0910062185 16.06.2015 Defer Date 16.09.2015 Pharmaceuticals.

463

Case No.:186/5/82-ALC4/2015 Party Name:DR REDDYS

Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00326/AM16/
RLA File :09/24/040/00150/AM16/
Lic.No/Date:0910062206 17.06.2015 Defer Date 16.09.2015 Pharmaceuticals.

464

Case No.:189/5/82-ALC4/2015 Party Name:AUROBINDO

PHARMA LIMITED Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00329/AM16/
RLA File :09/24/040/00163/AM16/
Lic.No/Date:0910062218 19.06.2015 Defer Date 16.09.2015

115

Pharmaceuticals.

465

Case No.:454/5/82-ALC4/2015 Party Name:CADILA

HEALTHCARE LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00594/AM16/
RLA File :08/24/040/00081/AM16/
Lic.No/Date:0810135519 22.06.2015 Defer Date 16.09.2015 Pharmaceuticals.

466

Case No.:455/5/82-ALC4/2015 Party Name:CADILA

HEALTHCARE LTD., Meet No/Date:5/82- ALC4/2015 25.06.2015 Deferred HQ File :01/82/050/00595/AM16/
RLA File :08/24/040/00082/AM16/
Lic.No/Date:0810135520 22.06.2015 Defer Date 16.09.2015 Pharmaceuticals.

Manual Agenda of NC Meeting No.05/82/2015
Scheduled to be held on 25.06.2015 but actually held on 05/08/2015

Case No. B-01

Meeting No.5/AM16
dated 25.06.2015
M/s. PI Industries Ltd. F. No.01/82/050/001017/AM15/DES-III RAF. No. 13/24/040/0025/AM 15 Adv. Lic. No. 1310047642 dated 26.9.2014

Decision: The Committee in light of the written comments of D/o C&PC Chemicals and Petrochemicals vide U.O.No.15022/6/2010-Ch-II dated 20.3.2015 decided to ratify the norms under para 4.07 of HBP vol.1 as per details given below or as applied by the firm whichever is less:-

Export product Qty. Import items Qty.

116

Ethyl 4-Chloro-2 Fluoro- 5[({[isopropyl(methyl)ami no]sulfonyl}amino)carbon yl]phenylcarbamate (PCM)

1kg 1 2-Chloro-4-Fluoro Toluene 0.599 kg 2 Methyl Iso Propyl Amine 0.322 kg 3 Noblyst (R) P8086 1% Pt 0.006 kg 4 Methanol 1.959 kg 5 Toluene 0.680 kg 6 Ethyl Chloroformate 0.370 kg 7 Sulfuryl Chloride 0.659 kg 8 n-Hexane 0.386 kg

RA concerned may take necessary action accordingly.

Case No. B-02

Meeting No.5/AM16
dated 25.06.2015 M/s. Navin Fluorine International Limited F. No.01/82/050/00446/AM15/DES-III RAF. No. 03/95/040/00915/AM 14 Adv. Lic. No. 0310772674 dated 03.03.2014
Decision: The Committee consider the case for ratification of norms under para 4.07 of HBP vol.1 as per agend and decided to defer the case for want of comments of D/o C&PC Chemicals.

Case No. B-03

Meeting No.5/AM16
dated 25.06.2015 M/s. Sainor Laboratories Pvt Ltd F. No.01/82/050/00528/AM10/DES-III 01/82/050/00621/AM10/DES-III RAF. No. 09/24/040/00040/AM 11 09/24/040/00040/AM 11 Adv. Lic. No.0910039225 dated 01.09.2009 0910039590 dated 14.10.2009 The Committee consider the case for ratification of norms under para 4.07 of HBP vol.1 as per agenda and decided to maintain status quo.

Case No. B-04

Meeting No.5/AM16
dated 25.06.2015 M/s. Sainor Laboratories Pvt Ltd F. No.01/82/050/00350/AM11/DES-III
RAF. No. 09/24/040/00040/AM 11 Adv. Lic. No.0910042075 dated 19.05.2010 Decision: The Committee consider the case for ratification of norms under para 4.07 of HBP vol.1 as per agenda and decided to defer the case for want of comments of D/o C&PC Chemicals.

Case No. B-05

Meeting No.5/AM16
dated 25.06.2015
M/s. Chirag Enterprise F. No.01/82/050/00256/AM11/DES-III 01/82/050/01090/AM11/DES-III RAF. No. 24/24/040/00009/AM 11 24/24/040/00014/AM 11 Adv. Lic. No. 2410029974 dated 27.10.2010 2410030871 dated 27.10.2010 Decision:
The Committee consider the case for ratification of norms under para 4.07 of HBP vol.1 as per agenda and decided to defer the case for want of comments of D/o C&PC PetroChemicals.

Case No. B-06

Meeting No.5/AM16
dated 25.06.2015 M/s. AVA Chemicals Pvt Ltd F. No.01/82/050/00793/AM14/DES-III RAF. No. 03/94/040/00485/AM 14 Adv. Lic. No. 0310749510 dated 13.09.2013

117

Decision: The Committee consider the case as per agenda and decided to correct the description to export product to be read as “Disodium Magnesium EDTA (Magnisium Content 6%+/-0.5)”. Rest of contents of the minutes of meeting no. 15/82 dated 31.10.2013 shall remain same.

Case No. B-07

Meeting No.5/AM16
dated 25.06.2015 Ref. From CSEZ Cochin M/s. Hikal Ltd.
F. No.01/82/162/117/AM14/DES-III Decision: In the light of written comments received from D/o Pharmaceuticals vide their OM No35011/607/2013-PI(Norms) dt.24.12.2013, it was decided to call for information from the firm: a. Certification from MSME, Bangalore on waste generated/solvent waste etc. b. Certification from Central Excise Authorities on past production consumption data of the firm for various export items c. Complete technical details as per Appendix-33 for each export items.

Case No. B-8

Meeting No.5/AM16
dated 25.06.2015 M/s. AVA Chemicals Pvt Ltd F. No.01/82/050/00864/AM13/DES-III RAF. No. 03/94/040/00448/AM 13 Adv. Lic. No. 0310709883 dated 21.09.2012
Decision: The Committee consider the case for ratification of norms under para 4.07 of HBP vol.1 as per agenda and decided to defer the case for want of comments of D/o C&PC Chemicals.

Case No. B- 9

Meeting No.5/AM16
dated 25.06.2015 M/s. Pharmazel (India) Pvt Ltd F. No.01/82/162/00138/AM15/DES-III

Decision: The Committee consider the case for ratification of norms under para 4.07 of HBP vol.1 as per agend and decided to defer the case for want of comments of D/o C&PC Chemicals.

Case No. B- 10

Meeting No.5/AM16
dated 25.06.2015 M/s. Saurav Chemicals Ltd F. No.01/82/050/00865/AM12/DES-III F. No.01/82/050/01382/AM13/DES-III RAF. No. 22/24/040/00039/AM 12 RAF. No. 22/24/040/00074/AM 13 Adv. Lic. No. 2210011843 dated 01.09.2011 Adv. Lic. No. 2210013689 dated 05.03.2013 Decision: The Committee consider the case for ratification of norms under para 4.07 of HBP vol.1 as per agend and decided to defer the case for want of comments of D/o C&PC Chemicals.

Case No. B-11

Meeting No.5/AM16
dated 25.06.2015 M/s. RA Chem Pharma Ltd F. No.01/82/050/00219/AM12/DES-III
RAF.No.09/24/040/00071/AM 12 Adv. Lic. No.0910046667 dated 06.05.2011 Decision: The Committee consider the case for ratification of norms under para 4.07 of HBP vol.1 as per agend and decided to defer the case for want of comments of D/o C&PC Pharmaceuticals.

Case No. B-12

Meeting No.5/AM16
dated 25.06.2015 M/s. Piramal Healthcare Ltd (Formely Nicholas Piramal) F. No.01/82/050/00557/AM13/DES-III RA No. 03/95/040/00227/AM 13 Adv. Lic. No. 0310701405 dated 10.07.2012

118

Decision: The Committee consider the case for revision of norms under para 4.07 of HBP vol.1 as per agenda and decided to defer the case for want of comments of D/o C&PC Pharmaceuticals.

Case No. B-13

Meeting No.5/AM16
dated 25.06.2015

M/s. Piramal Healthcare Ltd (Formely Nicholas Piramal) F. No.01/82/050/00556/AM13/DES-III F. No.01/82/050/00001/AM13/DES-III F. No.01/82/050/01173/AM13/DES-III Adv. Lic. No. 0310701402 dated 10.07.2012 Adv. Lic. No. 0310688849 dated 30.03.2012 Adv. Lic. No. 0310721416 dated 18.01.2013 Decision: Decision: The Committee consider the case for ratification of norms under para 4.07 of HBP vol.1 and decided to ratify norms as per details given below or as applied by the firm whichever is less:

Export product qty. Import items

for export of 1 no. tables 3.125mg 6.25mg
12.5mg
25.0mg
Carvedilol Tablets 1 no. tablet 1 Carvedilol 3.1875mg 6.375 mg 12.75 mg 25.5 mg 2 Lactose Monohydrate NF/BP (200 Mesh) Teva 10.0mg 20.0 mg 40.0 mg 80.0 mg 3 Povidone USP (PVP K 30) 1.50 mg 3.0 mg 6.0 mg 12.0 mg 4 Crospovidone NF 1.50 mg 3.0 mg 6.0 mg 12.0 mg 5 Lactose Monohydrate (pray dried) 32.75 mg 65.5 mg 131.0 mg 262.0 mg 6 to 15 Packing materials Relevant as per packing policy RA concerned may take action accordingly.

Case No. B-14

Meeting No.5/AM16
dated 25.06.2015 M/s. Piramal Healthcare Ltd (Formely Nicholas Piramal) F. No.01/82/050/00256/AM13/DES-III F. No.01/82/050/00261/AM13/DES-III F. No.01/82/050/00260/AM13/DES-III F. No.01/82/050/00255/AM13/DES-III F. No.01/82/050/00928/AM12/DES-III

Adv. Lic. No. 0310694731 dated 15.05.2012 Adv. Lic. No. 0310694936 dated 16.05.2012 Adv. Lic. No. 0310694925 dated 16.05.2012 Adv. Lic. No. 0310694706 dated 15.05.2012 Adv. Lic. No. 0310642739 dated 18.07.2011 Decision: The Committee considered this case for revision of norms under para 4.07 of HBP as per agenda. The Comittee in light of comment of the representative of D/o Pharamaceuticals in the meeting decided to revise the norms as per details given below or as applied by the firm:

Export product Qty Import items Qtykg./kg. Sterile polygeline solutions, Infusion for intravenous administration

Plasma Expander, 500ml PAUR size 1kg 1 Gelatin IP/PH/EUR 18.375 gm / 500ml pack 2 Purell RP 270G 1.05kg/kg content in the export product

119

3 4180 PP INSO CAPS
1.01 number RA may take further action as per decision of NC.

Case No. B-15

Meeting No.5/AM16
dated 25.06.2015

M/s. Encure Pharmaceuticals Ltd F. No.01/82/050/00297/AM15/DES-III RA F.No. 31/83/040/00197/AM 14 Adv. Lic. No. 3110062302 dated 27.01.2014 Decision: The Committee consider the case for ratification of norms under para 4.07 of HBP vol.1 as per agenda and decided to defer the case for want of comments of D/o C&PC Pharmaceuticals.

Case No. B-16

Meeting No.5/AM16
dated 25.06.2015
M/s. Makson Inds. Pvt Ltd F. No.01/82/050/00889/AM13/DES-III
RAF.No.03/95/040/00394/AM 13 Adv. Lic. No. 0310710561 dated 26.09.2012 Decision: The Committee consider the case for amendment in description of the items of export. The Committee in light of the written comment of O/o Development Commissioner (MSME) forwarded vide O.M.No.23(2)/2014-Chem dated 30.7.2015 decided to call for copy of a copy of export order in respect of said advance authorisation to make necessary correction in the description from the firm.

Case No. B-17

Meeting No.5/AM16
dated 25.06.2015
M/s. Dorf Ketal F. No.01/82/050/00594/AM12/DES-III
RAF.No.03/94/040/00203/AM 12 Adv. Lic. No. 0310636351 dated 15.06.2011 Decision: The committee decided to ratify the norms based on the recommendation of Department of C&PC U.O.No.14010/176/2011 Ch-II dt.09.01.2014 as per details given below or as applied by the firm whichever is less:-
Export product Qty. Import items Qty.kg. 62/0 – Chemical –solid wetting agent trade name RNB-51232/SR 1165YS SR 1165/SR 1182YS SR 1147 Trade name RNB-51232 (Plyglycol) 1kg Mono Ethylene Glycol/MEG 0.500 Witbreak DRI 9045 0.020 Alkyldiphenyloxide Di sulfonate/Calfax DB- 45/Dowfax2A1 0.180

Case No. B-18

Meeting No.5/AM16
dated 25.06.2015
M/s. Reliance Industries Ltd. F. No.01/82/050/790/AM15/DES-III
RAF.No.03/95/040/00269/AM 15 Adv. Lic. No. 0310789468 dated 19.09.2014 Decision: The Committee consider this case for correction in UOM of export product from kg. to MT as per agenda wherein norms has already ratified by NC in its meeting No.18/82 dated 18.2.2015 under

para 4.07 of HBP vol.1.

The Committee decided to correct the UOM of export produc “Acrylonitrile” from kg to MT.

RA may take necessary action accordingly.

120

Case No. B-19

Meeting No.5/AM16
dated 25.06.2015
M/s. Gulbrandsen F. No.01/82/050/00140/AM14/DES-III
RAF.No.34/24/040/00311/AM13 Adv. Lic. No. 3410036520 dated 25.03.2013 Decision: The committee decided to ratify the norms based on the recommendation C&PC U.O.No.14010/49/2011/Ch-II dt. 03.02.2015 as per details given below or as applied by the firm whichever is less:-
Export product Qty. Import items Qty. Mono butyl Tin Trichloride (MBTC) 1kg Tin Ingots 0.497 kg. Aluminium granules/Grits 0.062 kg. Butene-1 0.451 kg. Di-Butyl Tin Oxide (DBTO) 1kg Tin Ingots 0.564 kg. Aluminium granules/Grits 0.096 kg.

Butene-1 0.731 kg.

Case No. B-20

Meeting No.5/AM16
dated 25.06.2015
M/s. Gopinath Chem Tech Ltd. F. No.01/82/050/001421/AM11/DES-III
RAF.No.08/24/040/00270/AM11 Adv. Lic. No. 0810094594 dated 13.12.2010 Decision: The Committee consider the case for ratification of norms under para 4.07 of HBP vol.1 as per agenda and decided to defer the case for want of comments of D/o C&PC Pharmaceuticals.

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