IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2012-11-01

DGFT Committee Minutes

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Case No. B 348

M/s. Medreich Limited Norms Committee Meeting No.23/AM13 F.No. 01/82/50/00798/AM 11 F. No 01/82/50/00457/AM 11 F. No. 01/82/50/00863/AM 11 Meeting Date:1.11.2012 RA F. No. 07/24/40/00200/AM 11 RA F. No. 07/24/40/00072/AM 11 RA F. No. 07/24/40/00222/AM 11 Adv. Lic. No. & Date 0710073911 dated 30.8.2010 0710072323 dated 18.6.2010 0710074194 dated 16.9.2010 Decision: The firm was requested to appear before the Committee for personal hearing. However, the firm through email has requested for some other date as they were not able to get production and consumption data from Central Excise Department. It was decided to call the firm for PH on 16.11.2012. The case was deferred for 16.11.2012.

Case No. B 349

M/s. Coral Drugs Pvt. Ltd. F.No. 01/82/50/00226/AM 09/DES III Meeting Date:01.11.2012 05/24/040/00699/AM 08 0510213410 dated 12.7.2007 Decision: It was decided to defer the case for 29.11.2012 for comments of Department of Pharmaceuticals.

Case No. B 350

M/s. Divi’s Laboratories Limited N C itt M ti N 23/AM13 F N 01/82/50/01151/AM 12/DES III Office of Directorate General of Foreign Trade New Delhi 0

Para 4.7 Decision(DRAFT)

MEETING NUMBER : 23/82ALC4/2012 MEETING DATE : 01.11.2012 The Meeting No. 23/82 in the year 201213 to consider the cases under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to products falling in Chapter 29 and 30 was held on 01.11.2012 under the Chairmanship of, Shri Mukesh Bhatnagar, Addl DGFT in Room No.11, Udyog Bhawan, New Delhi.. Following members were present: 1. Shri S.K. Aggarwal, Jt. Development Commissioner, DC(MSME) 2. Shri D.N. Mathur, Consultant, Department of Pharmaceutical 3. Shri Jasbir Singh, Consultant, Department of Chemicals and Petrochemicals. 4. Shri R.C. Meena, Dy. Director General of Foreign Trade

F.No. 01/82/50/01151/AM 12/DES III 09/24/040/00369/AM 12 0910049648 dated 9.11.2011 Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/507/2012PI(Norms) dated 18.10.2012, it was decided to revise 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 items Quantity Allowed kg/kg Dextromethorphan HBr 1 kg 1. NFormal Octabase 1.35 2. Phosphorous Pentoxide 1.30 3. Hydrobromic Acid 47% 0.66 4. Methanol 2.033 Development Commissioner may take appropriate action as per the decision of Norms Committee.

Case No. B 351

M/s. Ruby Fragrance Pvt. Ltd. Vickramasigapuram (TN) F.No. 01/82/50/00966/AM 12/DES III F.No 01/82/050/00295/AM 12/DES III 35/24/040/0045/AM 12 35/24/040/00025/AM 12 3510035931 dated 25.5.2011 & 3510034005 dated 25.6.2011 Decision: It was decided to defer the case for 29.11.2012 for comments of Department of Chemicals and Petrochemicals.

Case No. B 352

M/s. Sandoz Pvt. Ltd. F.No. 01/82/50/00226/AM 09/DES III Decision: It was decided to defer the case for 29.11.2012 for comments of Department of Pharmaceuticals.

Case No. B 353

M/s. Yasho Industries Pvt. Ltd. F.No. 01/82/50/00220/AM 10/DES III 03/95/040/00163/AM 10 Adv Lic No & Date 0310524509 dated 17 6 2009

0310524509 dated 17.6.2009 Decision: It was decided to amend the description of export product from “Aromatic Derivative of Diphenylamine (Qureanti ADA) (Cumylated diphenul Amine/(4,4Dimethyl Benzyl)Diphenyl Amine)” to “Aromatic Derivative of Diphenylamine (ADA)”. RA may appropriate action as per the decision of Norms Committee.

Case No. B 354

M/s. Aqua Pharma Limited, Pune F.No. 01/82/162/01187/AM 11/DES III (Pt) 03/94/040/00428/AM 10 3110035873 dated 14.2.2008 Decision: It was decided to add words “Maxinol 5160 (Liquid Form)” in the export product. The Export item would be read as Partial Sodium Salt of Phosphine Polyacrylic Acid (Active content 50+3%): Maxinol 5160 (Liquid form). Development Commissioner may take appropriate action as per the decision of Norms Committee.

Case No. B 355

M/s. Alembic Limited, Vadodara F.No. 01/82/50/00095/AM 12/DES III (Pt) 34/24/040/00018/AM 10 3410024139 dated 8.5.2009 Decision: It was decided to examine the case on file. Accordingly, the case was deferred for 29.11.2012.

Case No. B 356

M/s. Pregna International Limited, Mumbai F.No. 01/82/50/00941/AM 13/DES III 03/95/040/00635/AM 12 0310665072 dated 15.11.2011 Decision: It was decided to defer the case for 29.11.2012 for comments of Petrochemical Division of Department of Chemicals and Petrochemicals.

Case No. B 357

M/s. Divi’s Laboratories Limited F.No. 01/82/50/00038/AM 12/DES III 09/24/040/00497/AM 11 0910045589 dated 18.2.2011 Decision: As far as delay in filing the representation is concerned, NC has recommended for consideration. However, the case was deferred for 29.11.2012 for comments of Department of Pharmaceuticals.

Case No. B 358

M/s. SI Group India Limited Norms Committee Meeting No 23/AM13 F No 01/82/50/01226/AM 09/DES III

F.No. 01/82/50/01226/AM 09/DES III 03/95/040/00306/AM 08 0310492305 dated 31.10.2008 Decision: It was decided to amend the description of export product from “3,3,5Trimethyl Cyclohexane” to “ Trimethylcyclohexanon”. RA may take appropriate action as per the decisionof Norms Committee.

Case No. B 359

M/s. Alkyl Amines Chemicals Limited, Mumbai F.No. 01/82/162/01648/AM 11/DES III (Pt.) 03/94/040/00428/AM 10 0310615980 dated 14.2.2011 Decision: It was decided to amend the description of export product from 3(2Ethoxy Hexoxy Propylamine) to “ 3(2Ethyl Hexoxy Propylamine)”. RA may take appropriate action as per the decision of Norms Committee.

Case No. B 360

M/s. Divis Laboratories Limited F.No. 01/82/50/01163/AM 12/DES III 09/24/040/00370/AM 12 0910049642 dated Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/506/2012PI(Norms) dated 18.10.2012, it was decided to revise 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 items Quantity Allowed kg/kg Nabumetone 1 kg 1. 2Acetyl6Methoxy Naphthalene 2.00 2. Methanol 6.54 Development Commissioner may take appropriate action as per the decision of Norms Committee.

Case No. B 361

M/s. Alembic Limited, Ahmedabad F.No. 01/82/050/01359/AM 12/DES III 34/24/040/00239/AM 12 3410033158 dated 8.2.2012 Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/319/2012PI(Norms) dated 12.9.2012, it was decided to revise the earlier norms fixed in NC meeting no. 14/82 dated 31.7.2012, under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export S.No Import items Quantity

p p p Quantity p Q y Allowed kg/kg Azithromycin Step 4 1 kg 1. Erythromycin Base USP 1.75 2. Hydroxylamine Hydrochloride 0.91 3. Methanol 2.72 4 Methane Sulfonyl Chloride 0.72 5. Acetone 6.45 6. Ethyl Alcohol 2.81 7. Platinum Catalyst with base of Activated Carbon 1.00 RA may take appropriate action as per the decision of Norms Committee.

Case No. B 362

M/s. J.B Chemicals Pharma Limited F.No. 01/82/50/179/AM 12/DES III 03/94/040/00055/AM 13 0310692273 dated 26.4.2012 Decision: It was decided to amend the description of import item from “Kanamycin Acid Sulphate” to “Kanamycin Acid Sulphate BP 2010”. RA may take appropriate action as per the decision of Norms Committee.

Case No. B 363

M/s. Lupin Limited F.No. 01/82/50/00417/AM 11/DES III 03/95/40/00127/AM 11 0310575276 dated 20.5.2010 Decision: It was decided to examine the case on file with regard to :  Validity of License  Reasons for delay It was also decided to send the application to the Department of Pharmaceuticals for their comments. Accordingly, the case was deferred for 29.11.2012.

Case No. B 364

M/s. Best Value Chem. Pvt. Ltd. F.No. 01/82/050/00290/AM 13/DES III F. No 01/82/050/00296/AM 13/DES III 34/24/040/00004/AM 13 34/24/040/00304/AM 12 3410033929 dated 23.4.2012 3410033928 dated 23.4.2012

Decision: It was decided to amend the description of first import item from Dichlopentadilene to “Dicyclopentadiene”. Rest of the minutes would remain same. RA may take appropriate action as per the decision of Norms Committee.

Case No. B 365

M/s. Vivimed Labs Limited F.No. 01/3/00351/AM 09/DES III 09/24/040/00514/AM 08 0910033449 dated 26.3.2008 Decision: It was decided to defer the case for 29.11.2012 for comments of Department of Chemicals and Petrochemicals.

Case No. B 366

M/s. Vivimed Labs Limited F.No. 01/82/50/01689/AM 11/DES III 09/24/040/00344/AM 11 0910045586 dated 18.2.2011 Decision: It was decided to give a last opportunity to the firm to appear before the Committee for personal hearing on 16.11.2012 otherwise the case would be closed. Accordingly, the case was deferred for 16.12.2012

Case No. B 367

M/s. Divis Laboratories Limited F.No. 01/82/162/00759/AM 12/DES III Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/503/2012PI (Norms) dated 18.10.2012, it was 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 Export Quantity S.No Import items Quantity Allowed kg/kg Naproxen 1 kg 1. BNaphthol 1.30 2. Methanol 3.34 3. Sulfuric Acid As per Central Excise Certificate 4. Ethylene Dichloride 0.89 5. C S Lye 4.014 6. Nitromethane 0.40 7 Acetyl Chloride 0.79 8. Aluminium Chloride 1.56 9 Sodium Carbonate As per Central Excise Certificate 10. Sodium Hydrosulfite

Monochloro acetic acid 1.02 12 2butanol 1.27 13 Toluene 1.80 14 ptoluenesulfonic acid 0.007 15 KOH flakes 1.32 16 Acetic Acid 1.04 17 Hydroxylamine sulfate or Hydroxylamine HCL 0.63 or 0.54 18 HCL As per Central Excise Certificate 19 Hyflo super cel 20 Activated carbon 0.10 21 Ammonia gas As per Central Excise Certificate 22 Disodium EDTA 23 NOctylDglucamine 0.10

Case No. B 368

M/s. Divis Laboratories Limited F.No. 01/82/162/00111/AM 13/DES III Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/467/2012PI(Norms) dated 18.10.2012, 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 items Quantity Allowed kg/kg Naproxen 1 kg 1. Mono chloro acetic acid 1.02 2. 2butanol 1.27 3. Toluene 1.80 4. Para toluene sulfonic acid 0.007 5. KOH flakes 1.32 6. 2Acetyl6 methoxynaphthalene 1.38 7. C S Lye 3.71 8. Acetic Acid 1.04 9. Hydroxylamine sulfate (or) Hydroxylamine HCL 0.63 or 0.54 10 HCL As per Central Excise Certificate 11 Sulfuric Acid 12 Hyflo super cell

13 Activated carbon 0.10 14. Ammonia gas As per Central Excise Certificate 15 Disodium EDTA 16 NOctylDglucamine 0.10 17 Methanol 1.87 18 Isopropyl alcohol 0.004

Case No. B 369

M/s. Yasho Industries Pvt. Ltd. F.No. 01/82/050/00424/AM 10 03/95/040/00251/AM 10 0310532642 dated 6.8.2009 Decision: It was decided to amend the description in the export product from Aromatic Derivative of Diphenylamine (Qureanti ADA) (Cumylated Diphenyl amine (4,4 Dimethyl Benzyl)Diphenyl Amine) to “Aromatic Derivative of Diphenylamine (ADA)”. Rest of the minutes would remain same.

Case No. B 370

F.No. 01/82/0162/00670/AM 12/DES III Decision: In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/68/2012Ch. II dated 30.10.2012, 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 items Quantity Allowed kg/kg 1, Hydroxy Ethylidene1,1 Diphosphonic Acid (Aquacid 105) 1 kg 1. 1 Hydroxy Ethylidene 1,1 diphosphonic Acid (60%) 0.835

Case No. B 371

F.No. 01/82/0162/00673/AM 12/DES III

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 items Quantity Allowed kg/kg Tetra Sodium Salt of 1, Hydroxy Ethylidene 1, 1 diphosphonic Acid (Aquacid 1054 EX) 1 kg 1. Caustic Soda Lye 0.360 kg 2. 1 Hydroxy Ethylidene 1,1 Diphosphonic Acid (60%) 0.355 kg

Case No. B 372

F.No. 01/82/0162/00674/AM 12/DES III 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 items Quantity Allowed kg/kg Aquacid 105 EX 1 Hydroxy Ethylidene Diphosphonic Acid (50%) 1 kg 1. 1 Hydroxy Ethylidene 1,1 Diphosphonic Acid (60%) 0.835

Acid (50%)

Case No. B 373

F.No. 01/82/0162/00671/AM 12/DES III 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 items Quantity Allowed kg/kg Aquacid 400 1 Hydroxy Ethylidene 11 Diphosphonic Acid (47%) 1 kg 1. 1 Hydroxy Ethylidene 1,1 Diphosphonic Acid (60%) 0.790

Case No. B 374

F.No. 01/82/0162/00672/AM 12/DES III 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 items Quantity Allowed kg/kg

Quantity Allowed kg/kg Sodium Salt of 1, Hydroxy Ethylidene 1, 1 Diphosphonic acid (92%) (Aquacid 1052 P) 1 kg 1. Caustic Soda Lye 0.880 2. 1 Hydroxy Ethylidene 1,1 Diphosphonic Acid (60%) 1.33

Case No. B 375

F.No. 01/82/0162/00679/AM 12/DES III Decision: It was decided to defer the case for 29.11.2012 for comments of Department of Chemicals and Petrochemicals.

Case No. B 375

F.No. 01/82/0162/00170/AM 12/DES III 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 Export Quantity S.No Import items Quantity Allowed kg/kg Aquacid 1054 P 1 kg 1. Caustic Soda Lye 1.046 kg 2. 1 Hydroxy Ethylidene 1,1 diphosphonic Acid (60%) 1.119 kg

Case No B 375

M/s Aqua Pharma Limited Pune

Case No. B 375

F.No. 01/82/0162/00171/AM 12/DES III less: Export product Export Quantity S.No Import items Quantity Allowed kg/kg Aquacid 106 EX Diethylene Tri Amine Penta (methylene Phosphonic Acid 50%) 1 kg 1. Diethylene Tri Amine (DETA) 0.090 kg 2. Phosphorous Trichloride Or Phosphorous Acid 0.620 Or 0.378

Case No. B 375

F.No. 01/82/0162/00172/AM 12/DES III less: Export product Export Quantity S.No Import items Quantity Allowed kg/kg Aquacid 1067 EXN Diethylene Tri Amine Methylene Phosphonic Acid Sodium Salt (53%) 1 kg 1. Caustic Soda Lye 0.300

Diethyelene Triamine (DETA) 0.085 3 Phosphorous Trichoride Or Phosphorous Acid 0.593 Or 0.352

Case No. B 375

F.No. 01/82/0162/00173/AM 12/DES III less: Export product Export Quantity S.No Import items Quantity Allowed kg/kg Aquacid 1067 EX Diethylene Tri Amine Hepta Sodium Salt (32%) 1 kg 1. Diethylene Tri Amine (DETA) 0.053 kg 2. Yellow Phosphorous Or Phosphorous Acid 0.083 0.190 3. Caustic Soda Lye 0.340

Case No. B 375

F.No. 01/82/0162/00174/AM 12/DES III

less: Export product Export Quantity S.No Import items Quantity Allowed kg/kg Aquacid 1068 EX Diethylene Tri Amine Penta (Methylene Phosphonic Acid Hepta Sodium Salt (41%) 1 kg 1. Diethylene Triamine (DETA) 0.057 2. Caustic Soda Lye 0.400 3 Phosphorous Trichloride Or Phosphorous Acid 0.403 Or 0.239

Case No. B 375

F.No. 01/82/0162/00175/AM 12/DES III less: Export product Export Quantity S.No Import items Quantity Allowed kg/kg Aquacid 108 EX Amino Tri Methylene Phosphonic Acid (50%) 1 kg 1. Yellow Phosphorous Or Phosphorous Acid 0.172 Or 0.420 2. Ammonium Chloride 0.089 Development Commissioner may take appropriate action as per the decision of Norms Committee

Case No. B 375

F.No. 01/82/0162/00176/AM 12/DES III less: Export product Export Quantity S.No Import items Quantity Allowed kg/kg Aquacid 1086 EX Amino Tri Methylene Phosphonic Acid Penta Sodium Salt (40%) 1 kg 1. Caustic Soda Lye 0.430 2. Amino Tri Methylene Phosphonic Acid (50%) 0.600

Case No. B 375

F.No. 01/82/0162/00177/AM 12/DES III less: Export product Export Quantity S.No Import items Quantity Allowed kg/kg Aquacid 1095 EX Ethylene Diamine Tetra 1 kg 1. Ethylene Diamine 0.0326

Diamine Tetra (Methylene Phsophonic Acid) Penta Sodium Salt (31.3%) 2. Caustic Soda Lye 0.330 3. Phosphorous Trichloride Or Phosphorous Acid 0.332 Or 0.200

Case No. B 375

F.No. 01/82/0162/00178/AM 12/DES III less: Export product Export Quantity S.No Import items Quantity Allowed kg/kg Aquacid 1076 EX Hexamethylene Diamine Tetra (Methylene Phosphonic Acid) Hexa Potassium Salt (33%) 1 kg 1. Hexamethylene Diamine (HMDA) 0.056 2. Phosphorous Trichloride Or Phosphorous Acid 0.265 Or 0.163

Case No. B 375

F.No. 01/82/0162/00179/AM 12/DES III less: Export product Export Quantity S.No Import items Quantity Allowed kg/kg Aquacid 1084 EXNO Amino Tri Methylene Phosphonic Acid Noxide Penta Potassium Salt (40%) 1 kg 1. Amino Tri Methylene Phosphonic Acid (50%) 0.500 2. Caustic Potash 0.233 Development Commissioner may take appropriate action as per the decision of Norms Committee.

Case No. B 375

F.No. 01/82/0162/00180/AM 12/DES III less: Export product Export Quantity S.No Import items Quantity Allowed kg/kg Aquacid 101 EX 2 Phsophonobutane 1,2,4 Tricarboxylic Acid (50%) 1 kg 1. Maleic Anhydride Or Dimethyl Maleate 0.190 Or 0.273 2. Dimethyl Phosphite 0.210 3 M th l A l t 0 170

Methyl Acrylate 0.170

Case No. B 375

F.No. 01/82/0162/00181/AM 12/DES III less: Export product Export Quantity S.No Import items Quantity Allowed kg/kg Aquacid 108 NS Amino Tri Methylene Phosphonic Acid (50%) 1 kg 1. Yellow Phosphorous Or Phosphorous Acid 0.172 Or 0.420 2. Ammonium Chloride 0.089

Case No. B 375

F.No. 01/82/0162/00182/AM 12/DES III less: Export product Export Quantity S.No Import items Quantity Allowed kg/kg

Quantity Allowed kg/kg Aquacid 106 NS Diethylene Tri amine Methylene Phosphonic Acid Sodium Salt (53%) 1 kg 1. Caustic Soda Lye 0.300 2. Diethyelene Triamine (DETA) 0.085 3. Phosphorous Trichloride Or Phosphorous Acid 0.593 Or 0.352

Case No. B 375

F.No. 01/82/0162/00183/AM 12/DES III less: Export product Export Quantity S.No Import items Quantity Allowed kg/kg Aquacid 105 NS 1 Hydroxy Ethylidene Diphosphonic Acid (50%) 1 kg 1. 1 Hydroxy Ethylidene 1,1 Diphosphonic Acid (60%) 0.835

Case No. B 375

F.No. 01/82/0162/00184/AM 12/DES III Adv Lic No & Date

less: Export product Export Quantity S.No Import items Quantity Allowed kg/kg Aquacid 108 EXLC Amino Tri Methylene Phosphonic Acid (50%) 1 kg 1. Yellow Phosphorous Or Phosphorous Acid 0.172 Or 0.420 2 Ammonium Chloride 0.089

Case No. B 375

F.No. 01/82/0162/00185/AM 12/DES III less: Export product Export Quantity S.No Import items Quantity Allowed kg/kg Aquacid 1082 EX Amino Tri Methylene Phosphonic Acid Ammonium Salt (18%) 1 kg 1. Amino Tri Methylene Phosphonic Acid (50%) 0.301 2 Liquor Ammonia (25%) 0.110

Case No. B 375

F.No. 01/82/0162/00186/AM 12/DES III less: Export product Export Quantity S.No Import items Quantity Allowed kg/kg Aquacid 1061 EX Diethylene Tri Amine Penta (Methylene Phosphonic) Acid (15.5%) 1 kg 1. Diethylene Tri Amine Penta (Methylene Phosphonic) Acid (50%) 0.310

Case No. B 375

F.No. 01/82/0162/00187/AM 12/DES III less: Export product Export Quantity S.No Import items Quantity Allowed kg/kg Aquacid 1051 P DiSodium Salt of 1 Hydroxy Ethylidene Diphosphonic 1 kg 1. Caustic Soda Lye 0.740

Diphosphonic Acid (92%) 2 1 Hydroxy Ethylidene 1,1 Diphosphonic Acid (60%) 1.362

Case No. B 375

F.No. 01/82/0162/00188/AM 12/DES III less: Export product Export Quantity S.No Import items Quantity Allowed kg/kg Aquacid 109 EX Ethylene Diamine Tetra Methylene Phosphonic Acid (92%) 1 kg 1. Ethylene Diamine 0.162 2. Yellow Phosphorous Or Phosphorous Acid 0.335 1.00

Case No. B 375

F.No. 01/82/0162/00189/AM 12/DES III

Export product Export Quantit S.No Import items Quantity Allowed kg/kg Aquacid 105 EXSP 1 hydroxy Ethylidene Diphosphonic Acid (58%) 1 kg 1. Phosphorous Acid 0.040 2 1 Hydroxy Ethylidene 1,1 Diphosphonic Acid (60%) 0.965 less:

Case No. B 375

F.No. 01/82/0162/00190/AM 12/DES III Decision: It was decided to defer the case for 29.11.2012 for comments of Department of Chemicals and Petrochemicals. 1

Case No.:54/41/82ALC4/2010

Party Name:GLAND PHARMA LIMITED Meet No/Date:23/82ALC4/2012 01.11.2012 Status:Case Deferred HQ File :01/82/050/01402/AM11/ RLA File :09/24/040/00289/AM11/ Lic.No/Date:0910043863 08.10.2010 Defer Date:29.11.2012 Decision :In the light of written comments received from Department of Pharmaceuticals, it was decided to put up the case on file for the approval of Director General of Foreign Trade. 2

Case No.:55/41/82ALC4/2010

Party Name:GLAND PHARMA LIMITED 01.11.2012 HQ File :01/82/050/01403/AM11/ RLA File :09/24/040/00298/AM11/ Lic.No/Date:0910043877 11.10.2010 Defer Date:29.11.2012 Decision :In the light of written comments received from Department of Pharmaceuticals, it was decided to put up the case on file for the approval of Director General of Foreign Trade.

Case No.:3/31/82ALC4/2010

Party Name:EMAMI LIMITED,

3 01.11.2012 HQ File :01/82/050/00928/AM11/ RLA File :02/24/040/00119/AM11/ Lic.No/Date:0210149202 12.10.2010 Defer Date:29.11.2012 Decision :It was decided to remind the firm to furnish the details sought vide DC(MSME) letter dated 12.9.2012. Accordingly, the case was defered for 29.11.2012. 4

Case No.:8/31/82ALC4/2010

Party Name:GLAND PHARMA LIMITED 01.11.2012 HQ File :01/82/050/00933/AM11/ RLA File :09/24/040/00290/AM11/ Lic.No/Date:0910043914 14.10.2010 Defer Date:29.11.2012 Decision :It was decided to defer the case for 29.11.2012 for comments of Department of Pharmaceuticals. 5

Case No.:48/31/82ALC4/2010

Party Name:GLAND PHARMA LIMITED 01.11.2012 HQ File :01/82/050/00973/AM11/ RLA File :09/24/040/00297/AM11/ Lic.No/Date:0910043978 20.10.2010 Defer Date:29.11.2012 6

Case No.:125/40/82ALC4/2010

Party Name:DSM ANTIINFECTIVES INDIA LTD 01.11.2012 HQ File :01/82/050/01324/AM11/ RLA File :22/24/040/00055/AM11/ Lic.No/Date:2210010568 25.10.2010 Defer Date:29.11.2012 Decision :It was decided to remind the firm to furnish the following without any further delay, otherwise the case would be closed: It was decided to remind the firm to furnish the following information immediately: • Complete chemical reactions for each step showing Mol. Wt. and molar requirement of each reactant and output product. • % yield on Molar Basis for each step for manufacturing process. • Material Balance for entire process showing justification for requirement of enzymes used in the process. • Requirement & Recovery of solvents of each step of manufacturing process • Past production visàvis actual consumption of raw material duly certified by Central Excise Authorities. The case was deferred for 29.11.2012. 7

Case No.:8/32/82ALC4/2010

Party Name:SAURAV CHEMICALS LTD, 01.11.2012 HQ File :01/82/050/00990/AM11/ RLA File :22/24/040/00050/AM11/ Lic.No/Date:2210010581 28.10.2010 Defer Date:29.11.2012

Case No.:2/34/82ALC4/2010

Party Name:ALEMBIC LIMITED 01.11.2012 HQ File :01/82/050/01008/AM11/ RLA File :34/24/040/00207/AM11/ Lic.No/Date:3410028544 09.11.2010 Defer Date:29.11.2012 9

Case No.:30/41/82ALC4/2010

Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 01.11.2012 HQ File :01/82/050/01378/AM11/ RLA File :05/23/040/00270/AM11/ Lic.No/Date:0510280724 30.12.2010 Defer Date:29.11.2012 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/337/2011PI(Norms) dated 14.3.2012, it was decided to call from the firm the following details: i) Complete technical details as per Appendix 33. ii) End use of the export product. iii) Complete chemical description of import items namely CMB. Accordingly the case was deferred for 29.11.2012. 10

Case No.:14/51/82ALC4/2010

Party Name:TITAN LABORATORIES PVT. LTD. 01.11.2012 Status:Case Approved HQ File :01/82/050/01731/AM11/ RLA File :03/95/040/00694/AM11/ Lic.No/Date:0310609837 06.01.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/518/2012PI(Norms) dated 18.10.2012, 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 items Quantity Allowed kg/kg Tamsulosin HCL SR Pellets 1 kg 1. Tamsulosin HCL 0.0016 2. Kollidon 30 (Povidone USP, NF, EP, JP (PVPK30) Polyvinylpyrro 0.1475 3. Starlac (Spay dried compound of maize starch USP/MF, EP & Lactose USP/NF, EP) 0.1100 4. Ethyl Cellulose N 10 USP (Ethyl cellulose USP/NF, EP, JP (10 CPS) 0.1380 d i ( i l d

Eudragit EPO (Basic Butylated Methacrylate Copolmer) 0.1100 6. Eudragit L 30 D55 (methacryclic Acid Copolymer Dispersion) 0.1680 7. Eudragit Rs 100 (Ammonia Methacrylate Copolymer) 0.1400 11

Case No.:23/6/82ALC4/2011

Party Name:MATRIX LABORATORIES LTD 01.11.2012 HQ File :01/82/050/00141/AM12/ RLA File :09/24/040/00484/AM11/ Lic.No/Date:0910045232 27.01.2011 Defer Date:29.11.2012 12

Case No.:15/12/82ALC4/2011

Party Name:ENCUBE ETHICALS PVT LTD 01.11.2012 HQ File :01/82/050/00348/AM12/ RLA File :03/94/040/00052/AM12/ Lic.No/Date:0310627904 25.04.2011 Defer Date:29.11.2012 Decision :It was decided to remind the firm to furnish the information sought by DC(MSME) vide their letter dated26.9.2012 within 15 days failing which their case would be closed. The case was deferred for 29.11.2012 13

Case No.:6/8/82ALC4/2011

Party Name:AUROBINDO PHARMA LIMITED 01.11.2012 HQ File :01/82/050/00206/AM12/ RLA File :09/24/040/00032/AM12/ Lic.No/Date:0910046590 02.05.2011 Defer Date:29.11.2012 14

Case No.:19/8/82ALC4/2011

Party Name:RA CHEM PHARMA LIMITED 01.11.2012 Status:Case Rejected HQ File :01/82/050/00219/AM12/ RLA File :09/24/040/00071/AM12/ Lic.No/Date:0910046667 06.05.2011 Defer Date: Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders. 15

Case No.:36/12/82ALC4/2011

Party Name:ALEMBIC PHARMACEUTICALS LTD 01.11.2012 Status:Case Rejected HQ File :01/82/050/00369/AM12/ RLA File :34/24/040/00016/AM12/ Lic.No/Date:3410030199 12.05.2011 Defer Date: Decision : The reply received from the firm has been forwarded to the Department of Pharmaceuticals The case was deferred for 29 11 2012 for comments of

Decision : The reply received from the firm has been forwarded to the Department of Pharmaceuticals. The case was deferred for 29.11.2012 for comments of Department of Pharmaceuticals. 16

Case No.:20/14/82ALC4/2012

Party Name:RANBAXY LABORATORIES LTD 01.11.2012 HQ File :01/82/050/00397/AM13/ RLA File :05/24/040/00082/AM12/ Lic.No/Date:0510292925 10.06.2011 Defer Date:29.11.2012 17

Case No.:4/16/82ALC4/2011

Party Name:BOSTIK INDIA PRIVATE LIMITED 01.11.2012 HQ File :01/82/050/00462/AM12/ RLA File :07/24/040/00073/AM12/ Lic.No/Date:0710079777 13.06.2011 Defer Date:29.11.2012 Decision : In the light of written comments received from Department of Industrial Policy and Promotion vide their note dated 1.11.2012, it was decided to call from the firm the following technical details:  Complete manufacturing process of the Export item ‘Hardener for Water Based Polyurethane’ using all imported and other indigenous raw material indicating loss at each stage of manufacture.  Justification for the quantity of import item i.e. ‘Poly isocyanate’ – 1350.00 Kgs for the manufacture of ‘Hardener for Water Based Polyurethane’1500.00 Kgs.  Quantity of production of Hardener for ‘Water Based Polyurethane’ visàvis consumption of both imported and indigenous raw material in the past 3 years, year wise separately, duly certified by a Chartered Accountant. The case was deferred for 29.11.2012. 18

Case No.:47/14/82ALC4/2011

Party Name:FDC LTD 01.11.2012 HQ File :01/82/050/00438/AM12/ RLA File :03/94/040/00152/AM12/ Lic.No/Date:0310637790 22.06.2011 Defer Date:29.11.2012 19

Case No.:31/21/82ALC4/2011

Party Name:MATRIX LABORATORIES LIMITED 01.11.2012 HQ File :01/82/050/00613/AM12/ RLA File :09/24/040/00143/AM12/ Lic.No/Date:0910047366 29.06.2011 Defer Date:29.11.2012

Case No.:1/35/82ALC4/2011

Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 01.11.2012

20 HQ File :01/82/050/00928/AM12/ RLA File :03/95/040/00278/AM12/ Lic.No/Date:0310642739 18.07.2011 Defer Date:29.11.2012 Decision :It was decided to remind the firm the furnish the following information within 15 days failing which the case would be closed: 1) Copy of Drug Manufacturing License alongwith list of approved items and approved composition of export product. 2) Copy of Master Batch Formula duly certified by Quality Control Incharge. The case was deferred for 29.11..2012 21

Case No.:28/21/82ALC4/2011

Party Name:HETERO DRUGS LIMITED, 01.11.2012 HQ File :01/82/050/00610/AM12/ RLA File :09/24/040/00178/AM12/ Lic.No/Date:0910047796 21.07.2011 Defer Date:29.11.2012 22

Case No.:19/20/82ALC4/2011

Party Name:SOFTGEL HEALTH CARE PVT. LTD., 01.11.2012 HQ File :01/82/050/00581/AM12/ RLA File :04/24/040/00363/AM11/ Lic.No/Date:0410126761 03.08.2011 Defer Date:29.11.2012 Decision :It was decided to remind the firm to furnish a copy of technical literature for conversion of 1 u to mg. The case was therefore, deferred for 29.11.2012. 23

Case No.:14/27/82ALC4/2011

Party Name:ARCH PHARMALABS LTD 01.11.2012 Status:Case Rejected HQ File :01/82/050/00764/AM12/ RLA File :03/94/040/00395/AM12/ Lic.No/Date:0310646407 04.08.2011 Defer Date: Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders. 24

Case No.:13/25/82ALC4/2011

Party Name:EMAMI LIMITED, 01.11.2012 HQ File :01/82/050/00680/AM12/ RLA File :02/24/040/00060/AM12/ Lic.No/Date:0210163383 05.08.2011 Defer Date:29.11.2012 Decision :It was decided to remind the firm to furnish the information sought vide DC(MSME) letter dated 12.9.2012. Accordingly, the case was deferred for 29.11.2012. 25

Case No.:28/26/82ALC4/2011

Party Name:INTAS PHARMACEUTICALS LTD., 01.11.2012 HQ File :01/82/050/00711/AM12/ RLA File :08/24/040/00114/AM12/ Lic No/Date:0810102412 Defer

25 HQ File :01/82/050/00711/AM12/ RLA File :08/24/040/00114/AM12/ Lic.No/Date:0810102412 11.08.2011 Defer Date:29.11.2012 26

Case No.:11/27/82ALC4/2011

Party Name:INDOFIL INDUSTRIES LTD. 01.11.2012 HQ File :01/82/050/00761/AM12/ RLA File :03/94/040/00465/AM12/ Lic.No/Date:0310650141 24.08.2011 Defer Date:29.11.2012 Decision :It was decided to defer the case for 29.11.2012 for comments of Department of Chemicals and Petrochemicals. 27

Case No.:9/27/82ALC4/2011

Party Name:INDOFIL INDUSTRIES LTD. 01.11.2012 HQ File :01/82/050/00759/AM12/ RLA File :03/94/040/00464/AM12/ Lic.No/Date:0310650335 25.08.2011 Defer Date:29.11.2012 28

Case No.:38/32/82ALC4/2011

Party Name:GRANULES INDIA LIMITED 01.11.2012 HQ File :01/82/050/00919/AM12/ RLA File :09/24/040/00239/AM12/ Lic.No/Date:0910048379 25.08.2011 Defer Date:29.11.2012 29

Case No.:89/42/82ALC4/2011

Party Name:VIVIMED LABS LIMITED 01.11.2012 HQ File :01/82/050/01124/AM12/ RLA File :09/24/040/00276/AM12/ Lic.No/Date:0910048679 08.09.2011 Defer Date:15.11.2012 Decision :It was decided to give a final opportunity to the firm to appear before the Committee on 16.11.2012 failing which the case would be closed. Accordingly the case was deferred for 16.11.2012 30

Case No.:114/42/82ALC4/2011

Party Name:ANUS LABORATORIES LTD., 01.11.2012 Status:Deffered HQ File :01/82/050/01149/AM12/ RLA File :09/24/040/00306/AM11/ Lic.No/Date:0910049026 23.09.2011 Defer Date:29.11.2012 Decision : It was decided to remind the firm to furnish the following information:  Complete technical details as per Appendix 33 of the proforma.  Past production visàvis actual consumption of all inputs duly certified by Central Excise Authority.

Accordingly, the case was deferred for 29.11.2012. 31

Case No.:14/41/82ALC4/2011

Party Name:MEDREICH LIMITED 01.11.2012 HQ File :01/82/050/01015/AM12/ RLA File :07/24/040/00254/AM12/ Lic.No/Date:0710083012 04.10.2011 Defer Date:15.11.2012 Decision :It was decided to call the firm for Personal Hearing on 16.11.2012 as desired by them. The case was therefore, deferred for 15.11.2012. 32

Case No.:113/42/82ALC4/2011

Party Name:NEULAND LABORATORIES LTD 01.11.2012 HQ File :01/82/050/01148/AM12/ RLA File :09/24/040/00310/AM12/ Lic.No/Date:0910049392 19.10.2011 Defer Date:29.11.2012 Decision :It was decided to remind the firm to furnish the technical details as sought vide minutes dated 4.10.2012 immediately. Accordingly, the case was deferred for 29.11.2012. 33

Case No.:25/41/82ALC4/2011

Party Name:CADILA HEALTHCARE LTD., 01.11.2012 HQ File :01/82/050/01026/AM12/ RLA File :08/24/040/00179/AM12/ Lic.No/Date:0810105257 08.11.2011 Defer Date:29.11.2012 34

Case No.:102/18/82ALC4/2012

Party Name:ADCOCK INGRAM LTD, 01.11.2012 Status:Case Approved HQ File :01/82/050/00597/AM13/ RLA File :07/24/040/00316/AM12/ Lic.No/Date:0710083853 11.11.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/459/2012PI(Norms) dated 31.10.2012, 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 items Quantity Allowed kg/kg Calcium Carbonate 1250 mg+Glycine 535.7 MGCAL SUP Tablets 1000 tablets 1. Glycine USP/BP Not shown in DML 2. Calcium Carbonate Dense BP/USP 1.25 kg RA may take appropriate action as per the decision of Norms Committee

RA may take appropriate action as per the decision of Norms Committee. 35

Case No.:4/9/82ALC4/2012

Party Name:ESTEEM INDUSTRIES PVT. LTD, 01.11.2012 Status:Case Approved HQ File :01/82/050/00249/AM13/ RLA File :17/24/040/00067/AM12/ Lic.No/Date:1710004590 15.11.2011 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their UO No. 14010/111/2011/Ch. II dated 30.10.2012, 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 items Quantity Allowed kg/kg NC Flakes (Stearic Diethanol Amine Condensate) (Appearance Creamish Flakes) 1 kg 1. Stearic Acid (Appearance off while flakes 0.765 kg 2. Diethanol Amine (Colourless clear liquid) 0.191 kg 3. Olelyl Alcohol 80/85 (Appearance liquid) 0.038 kg 4. Ethylene Oxide (Colourless Clear Liquid) 0.073 kg 36

Case No.:70/42/82ALC4/2011

Party Name:ORGANICA AROMATICS PVT LTD Meet No/Date:23/82ALC4/2012 01.11.2012 HQ File :01/82/050/01105/AM12/ RLA File :07/24/040/00314/AM12/ Lic.No/Date:0710084171 23.11.2011 Defer Date:29.11.2012 Decision :It was decided to remind the firm to furnish the details sought vide minutes of the previous meeting within 15 days failing which the case would be closed. Accordingly, the case was deferred for 29.11.2012. 37

Case No.:7/45/82ALC4/2011

Party Name:SANO MEDICAL KITS PVT. LTD., 01.11.2012 HQ File :01/82/050/01184/AM12/ RLA File :04/24/040/00244/AM12/ Lic.No/Date:0410131205 01.12.2011 Defer Date:29.11.2012 Decision :It was decided to remind the firm to furnish information sought vide minutes of earlier meetings immediately failing which the case would be closed. Accordingly, the case was deferred for 29.11.2012. C N 6/38/82 ALC4/2011 P N INDO GERMAN ALKALOIDS M N /D 23/82 ALC4/2012 St t C D f d

Case No.:6/38/82ALC4/2011

Party Name:INDO GERMAN ALKALOIDS 01.11.2012 HQ File :01/82/050/00992/AM12/ RLA File :03/94/040/00776/AM12/ Lic.No/Date:0310669794 09.12.2011 Defer Date:29.11.2012 Decision :It was decided to remind the firm to furnish the information sought vide minutes of earlier meeting within 15 days failing which the case would be closed. Accordingly, the case was deferred for 29.11.2012. 39

Case No.:23/3/82ALC4/2012

Party Name:PORUS LABORATORIES PVT LTD. 01.11.2012 HQ File :01/82/050/00027/AM13/ RLA File :09/24/040/00434/AM12/ Lic.No/Date:0910050371 22.12.2011 Defer Date:29.11.2012 Decision :It was decided to remind the firm to furnish the information sought vide minutes of earlier meetins within 15 days failing which the case would be closed. Accordingly, the case was deferred for 29.11.2012. 40

Case No.:4/40/82ALC4/2011

Party Name:DEEPAK NITRITE LIMITED 01.11.2012 Status:Case Rejected HQ File :01/82/050/01000/AM12/ RLA File :31/83/040/00137/AM12/ Lic.No/Date:3110052056 22.12.2011 Defer Date: Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders. 41

Case No.:79/4/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 01.11.2012 HQ File :01/82/050/00159/AM13/ RLA File :05/23/040/00364/AM12/ Lic.No/Date:0510312169 22.12.2011 Defer Date:29.11.2012 Decision :It was decided to send a copy of reply received from the firm along with the application to Department of Pharmaceuticals for their comments. Accordingly, the case was deferred for 29.11.2012. 42

Case No.:1/47/82ALC4/2011

Party Name:BROOKS LABORATORIES LTD., 01.11.2012 HQ File :01/82/050/01301/AM12/ RLA File :22/24/040/00067/AM12/ Lic.No/Date:2210012351 23.12.2011 Defer Date:29.11.2012 Decision :It was decided to remind the firm to furnish a copy of Drug Manufacturing License and also a copy of Master Batch Formula within 15 days failing which the case would be closed. Accordingly, the case was deferred for 29.11.2012. 43

Case No.:2/47/82ALC4/2011

Party Name:BROOKS LABORATORIES LTD., 01.11.2012 HQ File :01/82/050/01302/AM12/ RLA File :22/24/040/00066/AM12/ Lic.No/Date:2210012352 23 12 2011 Defer Date:29 11 2012

23.12.2011 Date:29.11.2012 Decision :It was decided to remind the firm to furnish a copy of Drug Manufacturing License and also a copy of Master Batch Formula within 15 days failing which the case would be closed. Accordingly, the case was deferred for 29.11.2012. 44

Case No.:43/21/82ALC4/2012

01.11.2012 HQ File :01/82/050/00673/AM13/ RLA File :09/24/040/00458/AM12/ Lic.No/Date:0910050481 29.12.2011 Defer Date:15.11.2012 Decision :It was decided to give a final opportunity to the firm to appear before the Committee for PH on 16.11.2012. The case was deferred for 16.11.2012 45

Case No.:5/45/82ALC4/2011

Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 01.11.2012 Status:Case Approved HQ File :01/82/050/01182/AM12/ RLA File :03/94/040/00755/AM12/ Lic.No/Date:0310674056 02.01.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/90/2011Ch. II dated 31.10.2012, 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 items Quantity Allowed kg/kg Hamber (7Acetyl 1,2,3,4,5,6,7,8 Octahydro 1,1,6,7=Tetramehtyl Naphthaline) 1 kg 1. Methyl Ethyl Ketone (MEK) 0.600 kg 2. Myrcene 1.00 kg 46

Case No.:57/3/82ALC4/2012

Party Name:ASCENT FINECHEM PVT. LTD., 01.11.2012 Status:Case Approved HQ File :01/82/050/00061/AM13/ RLA File :08/24/040/00224/AM12/ Lic.No/Date:0810107290 02.01.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their UO No. 14010/2012Ch. II dated 30.5.2012, 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 items Quantity Allowed kg/kg Para Methoxyphenyl Acetic Acid While Powder 1 kg 1 Para Cresol Clear colourless liquid 1.501 kg

While Powder 47

Case No.:13/3/82ALC4/2012

Party Name:INCHEM LABORATORIES PRIVATE LIMITED 01.11.2012 HQ File :01/82/050/00017/AM13/ RLA File :09/24/040/00467/AM12/ Lic.No/Date:0910050600 03.01.2012 Defer Date:29.11.2012 Decision :It was decided to remind the firm to furnish the technical details as per Appendix 33 immediately. The case was deferred for 29.11.2012. 48

Case No.:16/29/85ALC3/2011

Party Name:S.R.S.PHARMACEUTICALS PVT. LTD. 01.11.2012 Status:Case Deferred HQ File :01/85/050/00173/AM12/ RLA File :03/95/040/00831/AM12/ Lic.No/Date:0310674968 05.01.2012 Defer Date:29.11.2012 49

Case No.:69/1/82ALC4/2012

01.11.2012 HQ File :01/82/050/01511/AM12/ RLA File :09/24/040/00496/AM12/ Lic.No/Date:0910050771 13.01.2012 Defer Date:15.11.2012 Decision :It was decided to give a final opportunity to the firm to appear before the Committee for Personal Hearing on 16.11.2012 failing which their case would be closed. Accordingly, the case was deferred for 16.11.2012. 50

Case No.:23/51/82ALC4/2011

Party Name:INDSWIFT LABORATORIES LTD., 01.11.2012 HQ File :01/82/050/01416/AM12/ RLA File :22/24/040/00084/AM12/ Lic.No/Date:2210012473 25.01.2012 Defer Date:29.11.2012 51

Case No.:35/3/82ALC4/2012

01.11.2012 HQ File :01/82/050/00039/AM13/ RLA File :09/24/040/00532/AM12/ Lic.No/Date:0910051038 31.01.2012 Defer Date:15.11.2012 Decision :It was decided to give a final opportunity to the firm to appear for PH before the Committee on 16.11.2012 failing which their case would be closed. Accordingly, the case was deferred for 16.11.2012 52

Case No.:39/3/82ALC4/2012

01.11.2012 HQ File :01/82/050/00043/AM13/ RLA File :09/24/040/00528/AM12/ Lic.No/Date:0910051037 Defer

52 Q 31.01.2012 Date:15.11.2012 Decision :It was decided to give a final opportunity to the firm to appear for PH before the Committee on 16.11.2012 failing which their case would be closed. Accordingly, the case was deferred for 16.11.2012 53

Case No.:56/3/82ALC4/2012

Party Name:VINDHYA PHARMA (INDIA)PVT LTD. 01.11.2012 HQ File :01/82/050/00060/AM13/ RLA File :09/24/040/00494/AM12/ Lic.No/Date:0910051044 31.01.2012 Defer Date:29.11.2012 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for thier comments. Accordingly, the case was deferred for 29.11.2012. 54

Case No.:5/3/82ALC4/2012

Party Name:RA CHEM PHARMA LIMITED 01.11.2012 HQ File :01/82/050/00009/AM13/ RLA File :09/24/040/00519/AM12/ Lic.No/Date:0910051057 01.02.2012 Defer Date:29.11.2012 Decision :It was decided to remind the firm to furnish information sought vide minutes dated 4.10.2012 immediately. The case was deferred for 29.11.2012. 55

Case No.:28/3/82ALC4/2012

01.11.2012 HQ File :01/82/050/00032/AM13/ RLA File :09/24/040/00527/AM12/ Lic.No/Date:0910051095 02.02.2012 Defer Date:15.11.2012 Decision :It was decided to give a final opportunity to the firm to appear for PH before the Committee on 16.11.2012 failing which their case would be closed. Accordingly, the case was deferred for 16.11.2012 56

Case No.:37/3/82ALC4/2012

Party Name:ORTIN LABORATORIES LTD. 01.11.2012 Status:Deffered HQ File :01/82/050/00041/AM13/ RLA File :09/24/040/00492/AM12/ Lic.No/Date:0910051112 03.02.2012 Defer Date:29.11.2012 Decision : It was decided to defer the case for 29.11.2012 for comments of Department of Pharmaceuticals. 57

Case No.:4/3/82ALC4/2012

Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 01.11.2012 HQ File :01/82/050/00008/AM13/ RLA File :09/24/040/00509/AM12/ Lic.No/Date:0910051114 03.02.2012 Defer Date:29.11.2012 Decision :It was decided to remind the firm to furnish the technical details as per Appendix 33 immediately. The case was, therefore, deferred for 29.11.2012. 58

Case No.:29/3/82ALC4/2012

Party Name:PORUS LABORATORIES PVT LTD.

01.11.2012 HQ File :01/82/050/00033/AM13/ RLA File :09/24/040/00521/AM12/ Lic.No/Date:0910051178 09.02.2012 Defer Date:29.11.2012 Decision :In the light of written comments received from Department of Pharmaceuticals vide thier OM No. 35011/454/2012PI(Norms) dated 31.10.2012, it was decided to transfer the case to Department of Chemicals and Petrochemicals. Accordingly, the case was deferred for 29.11.2012. 59

Case No.:30/3/82ALC4/2012

Party Name:VIJAYASRI ORGANICS LTD 01.11.2012 Status:Case Approved HQ File :01/82/050/00034/AM13/ RLA File :09/24/040/00529/AM12/ Lic.No/Date:0910051204 10.02.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/433/2012PI(Norms) dated 30.09.2012, 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 items Quantity Allowed kg/kg 2Butyl5Chloro 3HImidazole4 Carbaldehyde (IMAL) 1 kg 1. Valeronitrile 1.19 2. Glycine 0.80 3. Dimethyl Formamide (DMF) 1.16 60

Case No.:40/1/82ALC4/2012

Party Name:MEDREICH LIMITED 01.11.2012 HQ File :01/82/050/01482/AM12/ RLA File :07/24/040/00455/AM12/ Lic.No/Date:0710086215 10.02.2012 Defer Date:15.11.2012 Decision :It was decided to call the firm for PH on 16.11.2012 as requested by them. Accordingly, the case was deferred for 16.11.2012. 61

Case No.:43/3/82ALC4/2012

Party Name:NECTAR LIFESCIENCES LIMITED, 01.11.2012 HQ File :01/82/050/00047/AM13/ RLA File :22/24/040/00087/AM12/ Lic.No/Date:2210012518 10.02.2012 Defer Date:29.11.2012 62

Case No.:18/8/82ALC4/2012

Party Name:SYMBIOTEC PHARMALAB LTD., 01.11.2012 HQ File :01/82/050/00210/AM13/ RLA File :56/24/040/00001/AM12/ Lic.No/Date:5610000024 Defer

62 HQ File :01/82/050/00210/AM13/ RLA File :56/24/040/00001/AM12/ Lic.No/Date:5610000024 13.02.2012 Defer Date:29.11.2012 63

Case No.:26/3/82ALC4/2012

Party Name:VIJAYASRI ORGANICS LTD 01.11.2012 Status:Case Approved HQ File :01/82/050/00030/AM13/ RLA File :09/24/040/00559/AM12/ Lic.No/Date:0910051239 13.02.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/433/2012PI(Norms) dated 30.09.2012, 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 items Quantity Allowed kg/kg 2Butyl5Chloro 3HImidazole4 Carbaldehyde (IMAL) 1 kg 1. Valeronitrile 1.19 2. Glycine 0.80 3. Dimethyl Formamide (DMF) 1.16 4. Phosphorous Oxy Chloride 64

Case No.:55/4/82ALC4/2012

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 01.11.2012 HQ File :01/82/050/00135/AM13/ RLA File :03/95/040/00886/AM12/ Lic.No/Date:0310681867 14.02.2012 Defer Date:29.11.2012 65

Case No.:49/1/82ALC4/2012

Party Name:BLUE CIRCLE ORGANICS PVT. LTD. 01.11.2012 HQ File :01/82/050/01491/AM12/ RLA File :03/94/040/00757/AM12/ Lic.No/Date:0310682083 15.02.2012 Defer Date:29.11.2012 Decision :It was decided to transfer the case to Department of Pharmaceuticals. The case was deferred for 29.11.2012 for comments of Department of Pharmaceuticals. 66

Case No.:73/4/82ALC4/2012

Party Name:DIVIS LABORATORIES LTD., 01.11.2012 Status:Case Approved HQ File :01/82/050/00153/AM13/ RLA File :09/24/040/00552/AM12/ Lic.No/Date:0910051394 22.02.2012 Defer Date:

Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/453/2012PI(Norms) dated 17.10.2012, 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 items Quantity Allowed kg/kg Iopamidol 1 kg 1. Dimethyl Formamide 0.710 2. N,N Dimethyl Acetamide 1.273 3. Methanol 2.92 4. Isopropyl Alcohol 7.39 5. Atipa Di Chloride 1.273 6. 2Acetoxy Propionyl Chloride 0.44 67

Case No.:20/4/82ALC4/2012

01.11.2012 HQ File :01/82/050/00100/AM13/ RLA File :03/94/040/01027/AM12/ Lic.No/Date:0310683207 23.02.2012 Defer Date:29.11.2012 Decision :It was decided to remind the firm to furnish information sought vide minutes dated 4.10.2012. The case was deferred for 29.11.2012. 68

Case No.:27/4/82ALC4/2012

01.11.2012 HQ File :01/82/050/00107/AM13/ RLA File :03/94/040/01049/AM12/ Lic.No/Date:0310683243 24.02.2012 Defer Date:29.11.2012 Decision :It was decided to remind the firm to furnish information sought vide minutes dated 4.10.2012. Accordingly, the case was deferred for 29.11.2012. 69

Case No.:63/4/82ALC4/2012

Party Name:DIVIS LABORATORIES LTD., 01.11.2012 HQ File :01/82/050/00143/AM13/ RLA File :09/24/040/00553/AM12/ Lic.No/Date:0910051453 27.02.2012 Defer Date: 29.11.2012 Decision : It was decided to defer the case for 29.11.2012 for comments of Department of Pharmaceuticals. 70

Case No.:66/4/82ALC4/2012

Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 01.11.2012 HQ File :01/82/050/00146/AM13/ RLA File :07/24/040/00479/AM12/ Lic.No/Date:0710086622 28.02.2012 Defer Date:29.11.2012

Case No.:69/3/82ALC4/2012

Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED 01.11.2012 Status:Case Approved HQ File :01/82/050/00073/AM13/ RLA File :52/24/040/00047/AM12/ Lic.No/Date:5210037956 28.02.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/45/2010Ch. II dated 4.7.2012, 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 items Quantity Allowed kg/kg 2 Carbetoxyamino 5Naphthol7 Sulfonic Acid 1 kg 1. J Acid 0.904 kg 2. Ethyl Chloro Formate 0.530 72

Case No.:83/4/82ALC4/2012

Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 01.11.2012 Status:Case Approved HQ File :01/82/050/00163/AM13/ RLA File :07/24/040/00477/AM12/ Lic.No/Date:0710086624 28.02.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/455/2012PI(Norms) dated 18.10.2012, 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 on prorata basis: Export product Export Quantity S.No Import items Quantity Allowed Amikacin Sulphate Injection USP 250 MG/ML, 2 ml vial 1000 nos. 1. Amikacin Sulphate USP/BP 366.98 gm 73

Case No.:21/4/82ALC4/2012

01.11.2012 HQ File :01/82/050/00101/AM13/ RLA File :03/94/040/01059/AM12/ Lic.No/Date:0310684071 29.02.2012 Defer Date:29.11.2012 Decision :It was decided to remind the firm to furnish the information sought vide minutes dated 4.10.2012. Accordingly, the case was deferred for 29.11.2012. 74 C 22/4/ 2 A C4/2012 A C A A A S / 23/82 A C4/2012 St t C D f d

Case No.:22/4/82ALC4/2012

01.11.2012 HQ File :01/82/050/00102/AM13/ RLA File :03/94/040/01067/AM12/ Lic.No/Date:0310684092 29.02.2012 Defer Date: 29.11.2012 Decision : It was decided to defer the case for 29.11.2012 for comments of Department of Pharmaceuticals. 75

Case No.:31/3/82ALC4/2012

01.11.2012 HQ File :01/82/050/00035/AM13/ RLA File :03/94/040/01052/AM12/ Lic.No/Date:0310684086 29.02.2012 Defer Date:29.11.2012 Decision :It was decided to remind the firm to furnish the information sought vide minutes dated 4.10.2012. Accordingly, the case was deferred for 29.11.2012. 76

Case No.:32/3/82ALC4/2012

01.11.2012 HQ File :01/82/050/00036/AM13/ RLA File :03/94/040/01066/AM12/ Lic.No/Date:0310684076 29.02.2012 Defer Date:29.11.2012 Decision :It was decided to remind the firm to furnish the information sought vide minutes dated 4.10.2012. Accordingly, the case was deferred for 29.11.2012. 77

Case No.:24/4/82ALC4/2012

Party Name:ENCUBE ETHICALS PVT LTD 01.11.2012 HQ File :01/82/050/00104/AM13/ RLA File :03/94/040/01071/AM12/ Lic.No/Date:0310684364 01.03.2012 Defer Date:29.11.2012 Decision :It was decided to remind the firm to furnish the details sought by DC(MSME) vide thier letter dated 12.9.2012. Accordingly, the case was deferred for 29.11.2012. 78

Case No.:19/3/82ALC4/2012

01.11.2012 HQ File :01/82/050/00023/AM13/ RLA File :03/94/040/01095/AM12/ Lic.No/Date:0310684494 02.03.2012 Defer Date:29.11.2012 Decision :It was decided to remind the firm to furnish the information sought vide minutes dated 4.10.2012. Accordingly, the case was deferred for 29.11.2012. 79

Case No.:19/4/82ALC4/2012

01.11.2012 HQ File :01/82/050/00099/AM13/ RLA File :03/94/040/01081/AM12/ Lic.No/Date:0310684500 02.03.2012 Defer Date:29.11.2012

Decision :It was decided to remind the firm to furnish the information sought vide minutes dated 4.10.2012. Accordingly, the case was deferred for 29.11.2012. 80

Case No.:23/4/82ALC4/2012

01.11.2012 HQ File :01/82/050/00103/AM13/ RLA File :03/94/040/01085/AM12/ Lic.No/Date:0310684507 02.03.2012 Defer Date:29.11.2012 Decision :It was decided to remind the firm to furnish the information sought vide minutes dated 4.10.2012. Accordingly, the case was deferred for 29.11.2012. 81

Case No.:25/4/82ALC4/2012

01.11.2012 HQ File :01/82/050/00105/AM13/ RLA File :03/94/040/01078/AM12/ Lic.No/Date:0310684488 02.03.2012 Defer Date:29.11.2012 Decision :It was decided to remind the firm to furnish the information sought vide minutes dated 4.10.2012. Accordingly, the case was deferred for 29.11.2012. 82

Case No.:74/4/82ALC4/2012

Party Name:PORUS LABORATORIES PVT LTD. 01.11.2012 HQ File :01/82/050/00154/AM13/ RLA File :09/24/040/00597/AM12/ Lic.No/Date:0910051589 02.03.2012 Defer Date:29.11.2012 83

Case No.:16/11/82ALC4/2012

Party Name:HETERO LABS LIMITED 01.11.2012 HQ File :01/82/050/00283/AM13/ RLA File :09/24/040/00609/AM12/ Lic.No/Date:0910051695 12.03.2012 Defer Date:29.11.2012 84

Case No.:2/4/82ALC4/2012

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 01.11.2012 Status:Case Approved HQ File :01/82/050/00082/AM13/ RLA File :07/24/040/00512/AM12/ Lic.No/Date:0710087004 15.03.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/56/2011Ch. II dated 28.5.2012, it was decided to ratify norms under Para 4.7of HBP v1 as per details given below or as applied by the firm, whichever is lower: Export product Export Q i S.No Import items Quantity Allowed k /k

Quantity kg/kg Magnesium Lacatate Gluconate 1 kg 1. Glucono Delta Lactone 0.755 kg Cobalt Gluconate 1 kg 1. 1.036 kg Zinc Gluconate 1 kg 1. 0.945 kg Magnesium Gluconate 1 kg 1. 0.945 kg Potassium Gluconate 1 kg 1. 0.930 kg Ferrous Gluconate 1 kg 1. 0.887 kg Manganese Gluconate 1 kg 1 0.945 kg Calcium Magnesium Lactate Gluconate 1 kg 1 0.831 kg 85

Case No.:21/8/82ALC4/2012

Party Name:ALEMBIC PHARMACEUTICALS LTD 01.11.2012 HQ File :01/82/050/00213/AM13/ RLA File :34/24/040/00289/AM12/ Lic.No/Date:3410033599 19.03.2012 Defer Date:29.11.2012 Decision :It was decided to defer the case for 29.11.2012 for comment of Department of Pharmaceuticals. 86

Case No.:17/11/82ALC4/2012

01.11.2012 HQ File :01/82/050/00284/AM13/ RLA File :09/24/040/00646/AM12/ Lic.No/Date:0910051917 28.03.2012 Defer Date:15.11.2012 Decision :It was decided to give a last opportunity to the firm to appear before Committee for PH on 16.11.2012 failing which the case would be closed. Accordingly, the case was deferred for 16.11.2012 87

Case No.:27/16/82ALC4/2012

01.11.2012 HQ File :01/82/050/00463/AM13/ RLA File :09/24/040/00671/AM12/ Lic.No/Date:0910052024 30.03.2012 Defer Date:15.11.2012 Decision :It was decided to give a last opportunity to the firm to appear before Committee for PH on 16.11.2012 failing which the case would be closed. Accordingly, the case was deferred for 16.11.2012

Case No.:36/11/82ALC4/2012

Party Name:LAKE CHEMICALS PRIVATE LIMITED 01.11.2012 HQ File :01/82/050/00303/AM13/ RLA File :07/24/040/00004/AM13/ Lic.No/Date:0710087698 16.04.2012 Defer Date:29.11.2012 89

Case No.:18/18/82ALC4/2012

01.11.2012 HQ File :01/82/050/00513/AM13/ RLA File :09/24/040/00034/AM13/ Lic.No/Date:0910052325 25.04.2012 Defer Date:29.11.2012 90

Case No.:9/18/82ALC4/2012

01.11.2012 HQ File :01/82/050/00504/AM13/ RLA File :09/24/040/00032/AM13/ Lic.No/Date:0910052326 25.04.2012 Defer Date:29.11.2012 91

Case No.:23/16/82ALC4/2012

01.11.2012 HQ File :01/82/050/00459/AM13/ RLA File :09/24/040/00043/AM13/ Lic.No/Date:0910052448 02.05.2012 Defer Date:15.11.2012 Decision :It was decided to give a last opportunity to the firm to appear before Committee for PH on 16.11.2012 failing which the case would be closed. Accordingly, the case was deferred for 16.11.2012 92

Case No.:26/11/82ALC4/2012

Party Name:BEST VALUE CHEM PVT. LTD. 01.11.2012 HQ File :01/82/050/00293/AM13/ RLA File :34/24/040/00025/AM13/ Lic.No/Date:3410034071 08.05.2012 Defer Date:29.11.2012 93

Case No.:17/18/82ALC4/2012

01.11.2012 HQ File :01/82/050/00512/AM13/ RLA File :09/24/040/00047/AM13/ Lic.No/Date:0910052581 10.05.2012 Defer Date:15.11.2012 Decision :It was decided to give a last opportunity to the firm to appear before Committee for PH on 16.11.2012 failing which the case would be closed. Accordingly, the case was deferred for 16.11.2012

Case No.:16/18/82ALC4/2012

Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED 01.11.2012 HQ File :01/82/050/00511/AM13/ RLA File :09/24/040/00074/AM13/ Lic.No/Date:0910052614 15.05.2012 Defer Date:29.11.2012 95

Case No.:5/9/83ALC1/2012

Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 01.11.2012 HQ File :01/83/050/00179/AM13/ RLA File :03/95/040/00088/AM13/ Lic.No/Date:0310695328 18.05.2012 Defer Date:29.11.2012 Decision :It was decided to remind the firm to furnish a copy of Drug Manufacturing License and Master Batch Formula. Accordingly, the case was deferred for 29.11.2012 96

Case No.:21/18/82ALC4/2012

01.11.2012 HQ File :01/82/050/00516/AM13/ RLA File :09/24/040/00095/AM13/ Lic.No/Date:0910052779 25.05.2012 Defer Date:29.11.2012 97

Case No.:23/18/82ALC4/2012

01.11.2012 HQ File :01/82/050/00518/AM13/ RLA File :09/24/040/00116/AM13/ Lic.No/Date:0910052859 01.06.2012 Defer Date:29.11.2012 98

Case No.:24/18/82ALC4/2012

Party Name:HETERO DRUGS LIMITED, 01.11.2012 HQ File :01/82/050/00519/AM13/ RLA File :09/24/040/00111/AM13/ Lic.No/Date:0910052860 01.06.2012 Defer Date:29.11.2012 99

Case No.:19/14/82ALC4/2012

Party Name:NEULAND LABORATORIES LTD 01.11.2012 HQ File :01/82/050/00396/AM13/ RLA File :09/24/040/00101/AM13/ Lic.No/Date:0910052939 08.06.2012 Defer Date:29.11.2012

100

Case No.:84/18/82ALC4/2012

Party Name:STERICON PHARMA PVT.LTD., 01.11.2012 HQ File :01/82/050/00579/AM13/ RLA File :07/24/040/00108/AM13/ Lic.No/Date:0710088798 13.06.2012 Defer Date:29.11.2012 Decision :It was decided to defer the case for 29.11.2012 for comments of Department of Biotechnology. 101

Case No.:13/18/82ALC4/2012

Party Name:AUROBINDO PHARMA LIMITED 01.11.2012 HQ File :01/82/050/00508/AM13/ RLA File :09/24/040/00132/AM13/ Lic.No/Date:0910053043 14.06.2012 Defer Date:29.11.2012 102

Case No.:2/23/82ALC4/2012

Party Name:INDSWIFT LABORATORIES LTD., 01.11.2012 HQ File :01/82/050/00802/AM13/ RLA File :22/24/040/00012/AM13/ Lic.No/Date:2210013015 14.06.2012 Defer Date:29.11.2012 103

Case No.:87/18/82ALC4/2012

Party Name:BILCARE LIMITED 01.11.2012 HQ File :01/82/050/00582/AM13/ RLA File :31/83/040/00051/AM13/ Lic.No/Date:3110054688 15.06.2012 Defer Date:29.11.2012 Decision :It was decided to examine the case on file. Accordingly, case was deferred for 29.11.2012. 104

Case No.:14/18/82ALC4/2012

Party Name:MYLAN LABORATORIES LIMITED 01.11.2012 HQ File :01/82/050/00509/AM13/ RLA File :09/24/040/00604/AM12/ Lic.No/Date:0910053078 18.06.2012 Defer Date:29.11.2012 105

Case No.:40/18/82ALC4/2012

Party Name:MYLAN LABORATORIES LIMITED 01.11.2012 HQ File :01/82/050/00535/AM13/ RLA File :09/24/040/00399/AM12/ Lic.No/Date:0910053076 18.06.2012 Defer Date:29.11.2012

106

Case No.:44/18/82ALC4/2012

Party Name:MYLAN LABORATORIES LIMITED 01.11.2012 HQ File :01/82/050/00539/AM13/ RLA File :09/24/040/00666/AM12/ Lic.No/Date:0910053075 18.06.2012 Defer Date:29.11.2012 107

Case No.:86/18/82ALC4/2012

Party Name:ADCOCK INGRAM LTD, 01.11.2012 HQ File :01/82/050/00581/AM13/ RLA File :07/24/040/00115/AM13/ Lic.No/Date:0710089034 19.06.2012 Defer Date:29.11.2012 108

Case No.:50/18/82ALC4/2012

Party Name:AMI LIFESCIENCES P LTD 01.11.2012 HQ File :01/82/050/00545/AM13/ RLA File :34/24/040/00072/AM13/ Lic.No/Date:3410034467 22.06.2012 Defer Date:29.11.2012 109

Case No.:4/18/82ALC4/2012

Party Name:MYLAN LABORATORIES LIMITED 01.11.2012 HQ File :01/82/050/00499/AM13/ RLA File :09/24/040/00110/AM13/ Lic.No/Date:0910053114 25.06.2012 Defer Date:29.11.2012 110

Case No.:108/18/82ALC4/2012

Party Name:FRESENIUS KABI ONCOLOGY LIMITED 01.11.2012 HQ File :01/82/050/00603/AM13/ RLA File :05/23/040/00471/AM12/ Lic.No/Date:0510328338 27.06.2012 Defer Date:29.11.2012 111

Case No.:111/18/82ALC4/2012

Party Name:JAGSONPAL PHARMACEUTICALS LTD. Meet No/Date:23/82ALC4/2012 01.11.2012 HQ File :01/82/050/00606/AM13/ RLA File :05/23/040/00075/AM13/ Lic.No/Date:0510328346 27.06.2012 Defer Date:29.11.2012

Case No.:20/18/82ALC4/2012

112 y 01.11.2012 HQ File :01/82/050/00515/AM13/ RLA File :09/24/040/00146/AM13/ Lic.No/Date:0910053163 03.07.2012 Defer Date:29.11.2012 113

Case No.:32/18/82ALC4/2012

Party Name:PMC RUBBER CHEMICALS INDIA PRIVATE LIMITED, 01.11.2012 HQ File :01/82/050/00527/AM13/ RLA File :02/24/040/00060/AM13/ Lic.No/Date:0210179279 03.07.2012 Defer Date:01.11.2012 Decision :It was decided to remind the firm to furnish the information sought vide minutes dated 4.10.2012. Accordingly, case was deferred for 29.11.2012. 114

Case No.:45/18/82ALC4/2012

01.11.2012 HQ File :01/82/050/00540/AM13/ RLA File :09/24/040/00152/AM13/ Lic.No/Date:0910053161 03.07.2012 Defer Date:29.11.2012 115

Case No.:74/18/82ALC4/2012

01.11.2012 HQ File :01/82/050/00569/AM13/ RLA File :09/24/040/00147/AM13/ Lic.No/Date:0910053162 03.07.2012 Defer Date:29.11.2012 116

Case No.:78/18/82ALC4/2012

01.11.2012 Status:Case Approved HQ File :01/82/050/00573/AM13/ RLA File :09/24/040/00145/AM13/ Lic.No/Date:0910053160 03.07.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/492/2012PI(Norms) dated 17.10.2012, it was decided to ratify norms under Para 4.7of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Quantity S.No Import items Quantity Allowed kg/kg Gefitinib 1 kg 1. 3Hydroxy4methoxy benzoic acid 0.892 2. 3Chloro4fluoro aniline 0.463

117

Case No.:31/18/82ALC4/2012

Party Name:SRIAM LABS PRIVATE LIMITED 01.11.2012 HQ File :01/82/050/00526/AM13/ RLA File :09/24/040/00143/AM13/ Lic.No/Date:0910053188 04.07.2012 Defer Date:29.11.2012 118

Case No.:28/18/82ALC4/2012

Party Name:DIVIS LABORATORIES LTD., 01.11.2012 HQ File :01/82/050/00523/AM13/ RLA File :09/24/040/00165/AM13/ Lic.No/Date:0910053195 05.07.2012 Defer Date:29.11.2012 119

Case No.:15/18/82ALC4/2012

Party Name:ASCENT FINECHEM PVT. LTD., 01.11.2012 HQ File :01/82/050/00510/AM13/ RLA File :08/24/040/00112/AM13/ Lic.No/Date:0810113196 09.07.2012 Defer Date:29.11.2012 120

Case No.:68/18/82ALC4/2012

Party Name:SMILAX LABORATORIES LIMITED 01.11.2012 HQ File :01/82/050/00563/AM13/ RLA File :09/24/040/00148/AM13/ Lic.No/Date:0910053214 09.07.2012 Defer Date:29.11.2012 121

Case No.:79/18/82ALC4/2012

Party Name:KUDOS CHEMIE LTD., 01.11.2012 HQ File :01/82/050/00574/AM13/ RLA File :22/24/040/00016/AM13/ Lic.No/Date:2210013078 09.07.2012 Defer Date:29.11.2012 122

Case No.:81/18/82ALC4/2012

01.11.2012 HQ File :01/82/050/00576/AM13/ RLA File :22/24/040/00015/AM13/ Lic.No/Date:2210013077 09.07.2012 Defer Date:29.11.2012

Case No :59/18/82 ALC4/2012

Part Name:S M CHEMICALS Meet No/Date:23/82 ALC4/2012 Status:Case

123

Case No.:59/18/82ALC4/2012

Party Name:S.M. CHEMICALS 01.11.2012 Status:Case Approved HQ File :01/82/050/00554/AM13/ RLA File :03/95/040/00234/AM13/ Lic.No/Date:0310701391 10.07.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/64/2010/Ch. II dated 26.10.2012, 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 items Quantity Allowed kg/kg 2 Ethylhexyl Diphenyl Phosphite (2 EHDP) 1 kg 1. Phenol 0.604 2. White/Yellow Phosphorous 0.0966 3. 2 Ethylhexanol 0.386 124

Case No.:60/18/82ALC4/2012

Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 01.11.2012 Status:Deffered HQ File :01/82/050/00555/AM13/ RLA File :03/95/040/00225/AM13/ Lic.No/Date:0310701398 10.07.2012 Defer Date:29.11.2012 Decision : It was decided to remind the firm to furnish a copy of Master Batch Formula for the export product duly certified by the Quality Control/Production Incharge of the company. Accordingly the case was deferred for 29.11.2012. 125

Case No.:61/18/82ALC4/2012

Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 01.11.2012 HQ File :01/82/050/00556/AM13/ RLA File :03/95/040/00226/AM13/ Lic.No/Date:0310701402 10.07.2012 Defer Date:29.11.2012 Decision :It was decided to remind the firm to furnish a copy of Drug Manufacturing License and also Master Batch Formula. Accordingly, the case was deferred for 29.11.2012. 126

Case No.:62/18/82ALC4/2012

Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 01.11.2012 HQ File :01/82/050/00557/AM13/ RLA File :03/95/040/00227/AM13/ Lic.No/Date:0310701405 10.07.2012 Defer Date:29.11.2012 Decision : It was decided to remind the firm to furnish a copy of Master Batch Formula for the export product duly certified by the Quality Control/Production Incharge of the company. Accordingly the case was deferred for 29.11.2012. 127

Case No.:82/18/82ALC4/2012

01.11.2012 HQ File :01/82/050/00577/AM13/ RLA File :22/24/040/00017/AM13/ Lic.No/Date:2210013080 Defer

10.07.2012 Date:29.11.2012 128

Case No.:85/18/82ALC4/2012

01.11.2012 HQ File :01/82/050/00580/AM13/ RLA File :22/24/040/00018/AM13/ Lic.No/Date:2210013079 10.07.2012 Defer Date:29.11.2012 129

Case No.:103/18/82ALC4/2012

Party Name:BALAJI AMINES LIMITED 01.11.2012 HQ File :01/82/050/00598/AM13/ RLA File :31/83/040/00071/AM13/ Lic.No/Date:3110054954 11.07.2012 Defer Date:29.11.2012 130

Case No.:7/18/82ALC4/2012

Party Name:PI INDUSTRIES LTD., 01.11.2012 HQ File :01/82/050/00502/AM13/ RLA File :13/24/040/00020/AM13/ Lic.No/Date:1310040327 11.07.2012 Defer Date:29.11.2012 131

Case No.:8/18/82ALC4/2012

Party Name:PI INDUSTRIES LTD., 01.11.2012 HQ File :01/82/050/00503/AM13/ RLA File :13/24/040/00022/AM13/ Lic.No/Date:1310040329 11.07.2012 Defer Date:29.11.2012 132

Case No.:91/18/82ALC4/2012

01.11.2012 HQ File :01/82/050/00586/AM13/ RLA File :22/24/040/00020/AM13/ Lic.No/Date:2210013092 12.07.2012 Defer Date:29.11.2012 133

Case No.:22/14/82ALC4/2012

Party Name:EMCURE PHARMACEUTICALS LTD. 01.11.2012 HQ File :01/82/050/00399/AM13/ RLA File :31/83/040/00070/AM13/ Lic.No/Date:3110054967 13.07.2012 Defer Date: 29.11.2012

Decision : It was decided to defer the case for 29.11.2012 for comments of Department of Pharmaceuticals. 134

Case No.:104/18/82ALC4/2012

Party Name:NECTAR LIFESCIENCES LIMITED, 01.11.2012 HQ File :01/82/050/00599/AM13/ RLA File :22/24/040/00014/AM13/ Lic.No/Date:2210013107 17.07.2012 Defer Date:29.11.2012 135

Case No.:26/18/82ALC4/2012

Party Name:DIVIS LABORATORIES LTD., 01.11.2012 HQ File :01/82/050/00521/AM13/ RLA File :09/24/040/00200/AM13/ Lic.No/Date:0910053258 17.07.2012 Defer Date: 13.12.2012 Decision : It was decided to defer the case for 13.12.2012 for comments of Department of Pharmaceuticals. 136

Case No.:27/18/82ALC4/2012

Party Name:DIVIS LABORATORIES LTD., 01.11.2012 Status:Case Approved HQ File :01/82/050/00522/AM13/ RLA File :09/24/040/00191/AM13/ Lic.No/Date:0910053259 17.07.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/507/2012PI(Norms) dated 18.10.2012, it was decided to ratify norms under Para 4.7of 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 Dextromethorphan Base 1 kg 1. NFormal Octabase 1.35 2. Phosphorous Pentoxide 1.30 3. Methanol 2.033 137

Case No.:30/18/82ALC4/2012

Party Name:UNITED PHOSPHORUS LTD. 01.11.2012 Status:Case Approved HQ File :01/82/050/00525/AM13/ RLA File :03/95/040/00114/AM13/ Lic.No/Date:0310702082 17.07.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 15022/22/2012Ch. II dated 1.11.2012, 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 Tris Tri Decyl Phsophite 1 kg 1. Yellow Phosphorous 0.069 kg

p 2. Methanol 0.215 kg 3. Iso Tri Decyl Alcohol (Tri Decyl Alcohol) 0.975 kg 138

Case No.:5/18/82ALC4/2012

Party Name:SWISS PARENTERALS PVT.LTD. 01.11.2012 HQ File :01/82/050/00500/AM13/ RLA File :08/24/040/00122/AM13/ Lic.No/Date:0810113430 17.07.2012 Defer Date:29.11.2012 139

Case No.:51/18/82ALC4/2012

Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 01.11.2012 HQ File :01/82/050/00546/AM13/ RLA File :04/24/040/00074/AM13/ Lic.No/Date:0410138168 17.07.2012 Defer Date:29.11.2012 140

Case No.:53/18/82ALC4/2012

Party Name:ENCUBE ETHICALS PVT LTD 01.11.2012 HQ File :01/82/050/00548/AM13/ RLA File :03/94/040/00304/AM13/ Lic.No/Date:0310702050 17.07.2012 Defer Date:29.11.2012 Decision :This case has been transferred to Department of Pharmaceuticals. It was decided to send a copy of application to Department of Pharmaceuticals for their comments. Accordingly, the case was deferred for 29.11.2012. 141

Case No.:98/18/82ALC4/2012

Party Name:NECTAR LIFESCIENCES LIMITED, 01.11.2012 HQ File :01/82/050/00593/AM13/ RLA File :22/21/040/00063/AM13/ Lic.No/Date:2210013106 17.07.2012 Defer Date:29.11.2012 142

Case No.:41/18/82ALC4/2012

Party Name:CADILA HEALTHCARE LTD., 01.11.2012 HQ File :01/82/050/00536/AM13/ RLA File :08/24/040/00131/AM13/ Lic.No/Date:0810113485 18.07.2012 Defer Date:29.11.2012 143

Case No.:47/18/82ALC4/2012

Party Name:ALEMBIC PHARMACEUTICALS LTD 01.11.2012 HQ File :01/82/050/00542/AM13/ RLA File :34/24/040/00103/AM13/ Lic No/Date:3410034667 Defer

143 HQ File :01/82/050/00542/AM13/ RLA File :34/24/040/00103/AM13/ Lic.No/Date:3410034667 18.07.2012 Defer Date:29.11.2012 144

Case No.:56/21/82ALC4/2012

Party Name:GRANULES INDIA LIMITED 01.11.2012 Status:Case Approved HQ File :01/82/050/00686/AM13/ RLA File :09/24/040/00187/AM13/ Lic.No/Date:0910053277 18.07.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 19/82 dated 9.8.2006, 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 Compresso Cotrim 90 (Sulfamethoxazole and Trimethoprim Granules DC) 1 kg 1. Sulfamethoxazole 0.750 kg 2. Trimethoprim 0.150 kg 3. Pregelatinised starch 0.043 kg 4. Croscarmellose sodium 0.040 kg 5. Povidone K 30 0.006 kg 6. Sodium Lauryl Sulfate 0.001 kg 7. Stearic Acid 0.010 kg 145

Case No.:70/18/82ALC4/2012

Party Name:INGA LABORATORIES PVT LIMITED 01.11.2012 HQ File :01/82/050/00565/AM13/ RLA File :03/94/040/00284/AM13/ Lic.No/Date:0310702227 18.07.2012 Defer Date:29.11.2012 146

Case No.:23/21/82ALC4/2012

Party Name:ASTRIX LABORATORIES LTD., 01.11.2012 HQ File :01/82/050/00653/AM13/ RLA File :09/24/040/00155/AM13/ Lic.No/Date:0910053315 20.07.2012 Defer Date:29.11.2012 147

Case No.:31/21/82ALC4/2012

Party Name:MSN LABORATORIES LIMITED 01.11.2012 HQ File :01/82/050/00661/AM13/ RLA File :09/24/040/00171/AM13/ Lic.No/Date:0910053316 20 07 2012 Defer Date:29 11 2012

20.07.2012 Date:29.11.2012 148

Case No.:35/18/82ALC4/2012

Party Name:INTAS PHARMACEUTICALS LTD., 01.11.2012 HQ File :01/82/050/00530/AM13/ RLA File :08/24/040/00128/AM13/ Lic.No/Date:0810113566 20.07.2012 Defer Date:29.11.2012 149

Case No.:61/21/82ALC4/2012

Party Name:SATYADEVA PHARMACEUTICALS /P/ LTD., 01.11.2012 HQ File :01/82/050/00691/AM13/ RLA File :09/24/040/00184/AM13/ Lic.No/Date:0910053311 20.07.2012 Defer Date:29.11.2012 150

Case No.:97/18/82ALC4/2012

01.11.2012 HQ File :01/82/050/00592/AM13/ RLA File :22/24/040/00022/AM13/ Lic.No/Date:2210013115 20.07.2012 Defer Date:29.11.2012 151

Case No.:99/18/82ALC4/2012

01.11.2012 HQ File :01/82/050/00594/AM13/ RLA File :22/24/040/00023/AM13/ Lic.No/Date:2210013116 20.07.2012 Defer Date:29.11.2012 152

Case No.:48/18/82ALC4/2012

Party Name:RONAK CHEMICALS 01.11.2012 HQ File :01/82/050/00543/AM13/ RLA File :34/24/040/00109/AM13/ Lic.No/Date:3410034708 23.07.2012 Defer Date:29.11.2012 153

Case No.:1/15/82ALC4/2012

Party Name:EMCURE PHARMACEUTICALS LTD. 01.11.2012 HQ File :01/82/050/00436/AM13/ RLA File :31/83/040/00067/AM13/ Lic.No/Date:3110055076 24.07.2012 Defer Date:29.11.2012 D i i It d id d t d f th f 29 11 2012 f t f D t t f Ph ti l

154

Case No.:58/21/82ALC4/2012

Party Name:SRINI PHARMACEUTICALS LTD., 01.11.2012 HQ File :01/82/050/00688/AM13/ RLA File :09/24/040/00166/AM13/ Lic.No/Date:0910053338 24.07.2012 Defer Date:29.11.2012 155

Case No.:59/21/82ALC4/2012

Party Name:SRINI PHARMACEUTICALS LTD., 01.11.2012 HQ File :01/82/050/00689/AM13/ RLA File :09/24/040/00201/AM13/ Lic.No/Date:0910053339 24.07.2012 Defer Date: 29.11.2012 Decision : It was decided to defer the case for 29.11.2012 for comments of Department of Pharmaceuticals. 156

Case No.:101/18/82ALC4/2012

Party Name:NECTAR LIFESCIENCES LIMITED, 01.11.2012 HQ File :01/82/050/00596/AM13/ RLA File :22/24/040/00025/AM13/ Lic.No/Date:2210013124 25.07.2012 Defer Date:29.11.2012 157

Case No.:11/21/82ALC4/2012

Party Name:ANUH PHARMA LTD. 01.11.2012 HQ File :01/82/050/00641/AM13/ RLA File :03/94/040/00293/AM13/ Lic.No/Date:0310703076 25.07.2012 Defer Date:29.11.2012 158

Case No.:13/21/82ALC4/2012

Party Name:SUNSHIELD CHEMICALS LTD. 01.11.2012 Status:Case Approved HQ File :01/82/050/00643/AM13/ RLA File :03/95/040/00035/AM13/ Lic.No/Date:0310703114 25.07.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/107/2012Ch. II dated 29.10.2012, 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 SDPA (Styrenated Di Phenylamine) 1 kg 1. DiPhenylamine 0.547 kg

y ) 159

Case No.:14/21/82ALC4/2012

Party Name:SALVI CHEMICAL INDUSTRIES LIMITED 01.11.2012 HQ File :01/82/050/00644/AM13/ RLA File :03/95/040/00259/AM13/ Lic.No/Date:0310703111 25.07.2012 Defer Date:29.11.2012 160

Case No.:27/21/82ALC4/2012

Party Name:STELLENCE PHARMSCIENCE PVT LTD 01.11.2012 HQ File :01/82/050/00657/AM13/ RLA File :07/24/040/00183/AM13/ Lic.No/Date:0710089972 31.07.2012 Defer Date:01.11.2012 161

Case No.:55/21/82ALC4/2012

Party Name:AUROBINDO PHARMA LIMITED 01.11.2012 HQ File :01/82/050/00685/AM13/ RLA File :09/24/040/00203/AM13/ Lic.No/Date:0910053388 31.07.2012 Defer Date:29.11.2012 162

Case No.:68/21/82ALC4/2012

Party Name:R L FINE CHEM 01.11.2012 Status:Case Approved HQ File :01/82/050/00698/AM13/ RLA File :07/24/040/00184/AM13/ Lic.No/Date:0710089982 31.07.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 40/82 dated 14.2.2012, 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 Clomipramine Hcl 1 Kg. 1. 1 Bromo 3 Chloro Propane 0.85 kg 2. 3 Chloro Iminodibenzyl 0.91 kg 163

Case No.:100/18/82ALC4/2012

01.11.2012 HQ File :01/82/050/00595/AM13/ RLA File :22/24/040/00026/AM13/ Lic.No/Date:2210013133 01.08.2012 Defer Date:29.11.2012

164

Case No.:12/21/82ALC4/2012

Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. 01.11.2012 HQ File :01/82/050/00642/AM13/ RLA File :03/95/040/00313/AM13/ Lic.No/Date:0310703725 01.08.2012 Defer Date:29.11.2012 165

Case No.:16/21/82ALC4/2012

Party Name:NEOGEN CHEMICALS LIMITED 01.11.2012 Status:Case Approved HQ File :01/82/050/00646/AM13/ RLA File :03/95/040/00275/AM13/ Lic.No/Date:0310703979 03.08.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/117/2011Ch. II dated 29.5.2012, 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 2Bromo Iso Butyric Iso Propyl Ester (2 Bromo Isobutyrated Isopropyl/Iso propyl 2Bromo Isobutyrate) 1 kg 1. Iso Butyric Acid 0.701 kg 2. Liquid Bromine 1.276 kg 3. Iso Propanol 1.078 kg 166

Case No.:17/21/82ALC4/2012

Party Name:LUPIN LIMITED 01.11.2012 HQ File :01/82/050/00647/AM13/ RLA File :03/95/040/00304/AM13/ Lic.No/Date:0310704078 03.08.2012 Defer Date:29.11.2012 167

Case No.:18/21/82ALC4/2012

Party Name:LUPIN LIMITED 01.11.2012 HQ File :01/82/050/00648/AM13/ RLA File :03/95/040/00303/AM13/ Lic.No/Date:0310704080 03.08.2012 Defer Date:29.11.2012 168

Case No.:35/21/82ALC4/2012

Party Name:PADMINI AROMATICS PVT. LTD 01.11.2012 HQ File :01/82/050/00665/AM13/ RLA File :07/24/040/00177/AM13/ Lic.No/Date:0710090045 03.08.2012 Defer Date:29.11.2012 D i i I d id d d f h f 29 11 2012 f f D f Ch i l d P h i l

169

Case No.:48/21/82ALC4/2012

Party Name:ALEMBIC PHARMACEUTICALS LTD 01.11.2012 HQ File :01/82/050/00678/AM13/ RLA File :34/24/040/00118/AM13/ Lic.No/Date:3410034784 03.08.2012 Defer Date:29.11.2012 170

Case No.:63/21/82ALC4/2012

Party Name:ASTRIX LABORATORIES LTD., 01.11.2012 HQ File :01/82/050/00693/AM13/ RLA File :09/24/040/00227/AM13/ Lic.No/Date:0910053422 03.08.2012 Defer Date:29.11.2012 171

Case No.:19/21/82ALC4/2012

Party Name:LUPIN LIMITED 01.11.2012 HQ File :01/82/050/00649/AM13/ RLA File :03/95/040/00305/AM13/ Lic.No/Date:0310704227 06.08.2012 Defer Date:29.11.2012 172

Case No.:9/21/82ALC4/2012

Party Name:GLENMARK GENERICS LIMITED 01.11.2012 Status:Case Approved HQ File :01/82/050/00639/AM13/ RLA File :03/94/040/00319/AM13/ Lic.No/Date:0310704095 06.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/447/2012PI(Norms) dated 18.10.2012, 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 Telmisartan 1 kg 1 2npropyl4methyl6(1methyl benzimidazole2yl) benzimidazole 0.82 2. 4Methyl2biphenylcarboxylic Acid Methyl Ester 0.65 3. Acetone 0.46 4. Ethylene Dichloride 1.69 5. Methanol 0.43 6. Methylene Chloride 2.96 7. Methyl Isobutyl Ketone 0.72 8. NBromo Succinimide 0.56

173

Case No.:28/21/82ALC4/2012

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 01.11.2012 Status:Case Approved HQ File :01/82/050/00658/AM13/ RLA File :07/24/040/00142/AM13/ Lic.No/Date:0710090154 09.08.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 36 dated 7.12.2010, 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 Calcium Gluconate Injectable Grade USP 1 kg 1. Calcium Gluconate (Oral Grade) 1.09 kg Calcium Boro Gluconate 1 kg. 1. Calcium Gluconate (Oral Grade) 0.946 kg Calcium Glubionate 1 kg. 1. Calcium Gluconate (Oral Grade) 0.430 kg 174

Case No.:29/21/82ALC4/2012

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 01.11.2012 HQ File :01/82/050/00659/AM13/ RLA File :07/24/040/00143/AM13/ Lic.No/Date:0710090155 09.08.2012 Defer Date:29.11.2012 175

Case No.:26/22/82ALC4/2012

01.11.2012 HQ File :01/82/050/00729/AM13/ RLA File :09/24/040/00243/AM13/ Lic.No/Date:0910053480 10.08.2012 Defer Date:15.11.2012 Decision :It was decided to give a last opportunity to the firm to appear before the Committee for PH on 16.11.2012. The case was therefore, deferred for 16.11.2012. 176

Case No.:3/18/82ALC4/2012

Party Name:UNITED BIOTECH PVT.LTD. 01.11.2012 HQ File :01/82/050/00498/AM13/ RLA File :05/24/040/00185/AM13/ Lic.No/Date:0510331907 14.08.2012 Defer Date:29.11.2012 177

Case No.:65/21/82ALC4/2012

Party Name:INCHEM LABORATORIES PRIVATE LIMITED 01.11.2012 HQ File :01/82/050/00695/AM13/ RLA File :09/24/040/00239/AM13/ Lic.No/Date:0910053490 14.08.2012 Defer Date:29.11.2012 Decision :It was decided to remind the firm to furnish the details in Annexure 33. Accordingly, the case was deferred for 29.11.2012.

178

Case No.:70/21/82ALC4/2012

01.11.2012 HQ File :01/82/050/00700/AM13/ RLA File :22/24/040/00028/AM13/ Lic.No/Date:2210013172 14.08.2012 Defer Date:29.11.2012 179

Case No.:37/21/82ALC4/2012

Party Name:GULBRANDSEN CHEMICALS PVT LTD 01.11.2012 HQ File :01/82/050/00667/AM13/ RLA File :34/24/040/00127/AM13/ Lic.No/Date:3410034859 16.08.2012 Defer Date:29.11.2012 180

Case No.:32/21/82ALC4/2012

Party Name:BIOTECH OPHTHALMICS PVT. LTD., 01.11.2012 HQ File :01/82/050/00662/AM13/ RLA File :08/24/040/00137/AM13/ Lic.No/Date:0810114338 17.08.2012 Defer Date:29.11.2012 181

Case No.:40/21/82ALC4/2012

Party Name:VITAL LABORATORIES PVT. LTD. 01.11.2012 HQ File :01/82/050/00670/AM13/ RLA File :03/95/040/00254/AM13/ Lic.No/Date:0310705409 17.08.2012 Defer Date:29.11.2012 182

Case No.:41/21/82ALC4/2012

Party Name:MEDLEY PHARMACEUTICALS LIMITED 01.11.2012 HQ File :01/82/050/00671/AM13/ RLA File :03/95/040/00273/AM13/ Lic.No/Date:0310705411 17.08.2012 Defer Date:29.11.2012 183

Case No.:62/21/82ALC4/2012

Party Name:VASUDHA PHARMA CHEM LTD 01.11.2012 HQ File :01/82/050/00692/AM13/ RLA File :09/24/040/00204/AM13/ Lic.No/Date:0910053534 17.08.2012 Defer Date:29.11.2012

Case No.:64/21/82ALC4/2012

Party Name:ECOLOGIC CHEMICALS LIMITED

184 01.11.2012 HQ File :01/82/050/00694/AM13/ RLA File :09/24/040/00199/AM13/ Lic.No/Date:0910053533 17.08.2012 Defer Date:29.11.2012 185

Case No.:114/18/82ALC4/2012

Party Name:PCL OIL & SOLVENTS LTD., 01.11.2012 Status:Case Approved HQ File :01/82/050/00609/AM13/ RLA File :05/24/040/00186/AM13/ Lic.No/Date:0510332132 21.08.2012 Defer Date: Decision : In the light of written comments received from Petrochemical Division of Department of Chemicals and Petrochemicals vide their OM No. 46011/119/2012PCII dated 18.10.2012, 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 PVC Plasticizer 1 kg 1. Phthalic Anhydride 0.400 kg 2. 2 Ethylhexanol (Octaonol) 0.700 kg 186

Case No.:36/21/82ALC4/2012

Party Name:CADILA HEALTHCARE LTD., 01.11.2012 HQ File :01/82/050/00666/AM13/ RLA File :08/24/040/00147/AM13/ Lic.No/Date:0810114381 21.08.2012 Defer Date:29.11.2012 187

Case No.:69/21/82ALC4/2012

Party Name:ASCENT FINECHEM PVT. LTD., 01.11.2012 HQ File :01/82/050/00699/AM13/ RLA File :08/24/040/00160/AM13/ Lic.No/Date:0810114398 21.08.2012 Defer Date:29.11.2012 188

Case No.:24/21/82ALC4/2012

Party Name:R L FINE CHEM 01.11.2012 HQ File :01/82/050/00654/AM13/ RLA File :07/24/040/00218/AM13/ Lic.No/Date:0710090322 22.08.2012 Defer Date:29.11.2012

Case No.:33/21/82ALC4/2012

Party Name:SYMBIOTEC PHARMALAB LTD., 01.11.2012

189 HQ File :01/82/050/00663/AM13/ RLA File :56/24/040/00014/AM13/ Lic.No/Date:5610000958 22.08.2012 Defer Date:29.11.2012 190

Case No.:34/21/82ALC4/2012

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 01.11.2012 Status:Case Approved HQ File :01/82/050/00664/AM13/ RLA File :07/24/040/00141/AM13/ Lic.No/Date:0710090320 22.08.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/56/2011Ch. II dated 23.5.2012, it was 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 Exp. Qty. Sl.No. Import items Qty. allowed Calcium Lactate Gluconate 1 kg 1. Lactic AcidAny grade 0.560 kg 2. Calcium Gluconate Oral Grade 0.686 kg 3. Calcium Carbonate 0.310 kg Ferrous Lactate 1 kg 1 Lactic Acid any grade 1.028 kg Magnesium Lactate 1 kg 1. Lactic Acidany grade 1.19 kg Zinc Lactate 1 kg 1 Lactic Acidany grade 0.990 kg Magnesium Lactate Gluconate 1 kg 1. Lactic Acidany grade 0.390 kg 2. Gluconate Delta Lactone 0.755 kg 191

Case No.:52/21/82ALC4/2012

Party Name:BAL PHARMA LTD 01.11.2012 HQ File :01/82/050/00682/AM13/ RLA File :07/24/040/00221/AM13/ Lic.No/Date:0710090348 23.08.2012 Defer Date:29.11.2012 192

Case No.:66/21/82ALC4/2012

Party Name:SHIVA PHARMACHEM LTD, 01.11.2012 HQ File :01/82/050/00696/AM13/ RLA File :34/24/040/00139/AM13/ Lic.No/Date:3410034986 27.08.2012 Defer Date:29.11.2012 193

Case No.:6/21/82ALC4/2012

Party Name:UNITED BIOTECH PVT.LTD. 01.11.2012 HQ File :01/82/050/00636/AM13/ RLA File :05/24/040/00202/AM13/ Lic.No/Date:0510332772 28.08.2012 Defer Date:29.11.2012 Decision :It was decided to defer the case for 29 11 2012 for comments of Department of Pharmaceuticals

194

Case No.:25/21/82ALC4/2012

Party Name:DHANUKA LABORATORIES LTD. 01.11.2012 HQ File :01/82/050/00655/AM13/ RLA File :05/23/040/00183/AM13/ Lic.No/Date:0510333412 03.09.2012 Defer Date:29.11.2012 195

Case No.:2/21/82ALC4/2012

Party Name:ZEE LABORATORIES 01.11.2012 HQ File :01/82/050/00632/AM13/ RLA File :05/24/040/00220/AM13/ Lic.No/Date:0510334505 12.09.2012 Defer Date:29.11.2012 196

Case No.:3/21/82ALC4/2012

Party Name:CADILA HEALTHCARE LTD., 01.11.2012 HQ File :01/82/050/00633/AM13/ RLA File :08/24/040/00144/AM13/ Lic.No/Date:0810115056 12.09.2012 Defer Date:29.11.2012 197

Case No.:4/23/82ALC4/2012

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 01.11.2012 Status:Case Approved HQ File :01/82/050/00804/AM13/ RLA File :04/24/040/00103/AM13/ Lic.No/Date:0410139890 20.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/328/2012PI(Norms) dated 10.9.2012, 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 Gabapentin 1 kg 1. 1,1Cyclohexane Diacetic Acid Monamide 1.63 kg 2. Methanol 0.445 kg 3. Toluene 0.89 kg 4. Isopropyl alcohol 2.165 kg 5. Caustic Soda Flakes 0.723 kg 198

Case No.:72/21/82ALC4/2012

Party Name:BELCO PHARMA 01.11.2012 HQ File :01/82/050/00702/AM13/ RLA File :05/23/040/00176/AM13/ Lic.No/Date:0510335291 Defer

198 HQ File :01/82/050/00702/AM13/ RLA File :05/23/040/00176/AM13/ Lic.No/Date:0510335291 20.09.2012 Defer Date:29.11.2012 199

Case No.:73/21/82ALC4/2012

Party Name:PI INDUSTRIES LTD., 01.11.2012 HQ File :01/82/050/00703/AM13/ RLA File :13/24/040/00028/AM13/ Lic.No/Date:1310041094 20.09.2012 Defer Date:29.11.2012 200

Case No.:1/23/82ALC4/2012

Party Name:RANBAXY LABORATORIES LTD 01.11.2012 HQ File :01/82/050/00801/AM13/ RLA File :05/24/040/00235/AM13/ Lic.No/Date:0510336113 28.09.2012 Defer Date: 13.12.2012 Decision : : It was decided to defer the case for 13.12.2012 for comments of Department of Pharmaceuticals. 201

Case No.:3/23/82ALC4/2012

Party Name:TITAN LABORATORIES PVT. LTD. 01.11.2012 HQ File :01/82/050/00803/AM13/ RLA File :03/95/040/00544/AM13/ Lic.No/Date:0310713360 22.10.2012 Defer Date:29.11.2012 Date:05.11.2012 Place:New Delhi Lalita Maini Foreign Trade Development Officer

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