IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2013-04-18

DGFT Committee Minutes

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Office of Directorate General of Foreign Trade New Delhi 0

Para 4.7 Decision

MEETING NUMBER : 2/82ALC4/2013 MEETING DATE : 18.04.2013 The Meeting No. 2/82 in the year 201314 to consider the cases under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to products falling in Chapter 29 and 30 was scheduled to be held on 18.4.2013 but was actually held on 26.4.2013 under the Chairmanship of, Shri Mukesh Bhatnagar, Addl DGFT in Room No.11, Udyog Bhawan, New Delhi.. Following members were present: 1. Shri D.N. Mathur. Advisor, Department of Pharmaceutical 2. hri Shri S.K. Aggarwal, Asstt. Development Commissioner, DC(MSME) 3. Shri R.C. Meena, Deputy Director General of Foreign Trade

Case No. B12

M/s. Aurobindo Pharma Limited, Hyderabad Meeting no. 2/AM 13 Dated 18.4.2013 01/82/162/00894/AM 13/DES III RLA File No. 09/70/040/00378/AM 13 Advance Authorisation No. 0910054262 dated 6.11.2011 Decision: It was decided to revise 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 Exp. Qty. Sl.No. Import items Qty. allowed Levetiracetam 1 kg 1 (s)+2 Amino butyramide HCL 0.95 kg 2. Methylene Chloride 4.514 kg 3. Carbon enonticromos (Activated Carbon) 0.0120 kg 4. Steam/Thermal Coal As per fuel policy RA may take appropriate action as per the decision of Norms Committee.

Case No. B13

M/s. Crown Chemicals Pvt. Limited 01/82/162/00622/AM 13/DES III RLA File No. 03/94/40/00309/AM 13 0310703754 dated 1.8.2012 Decision: It was decided to defer the case for 16.5.2013 for comments of Department of Chemicals and Petrochemicals.

Case No. B14

M/s. Jubilant Lifesciences Limited 01/82/50/00248/AM 10/DES III RLA File No. 05/24/040/00146/AM 10 0510244396 dated 24.6.2009 Decision: It was noticed that the case was already approved in NC meeting no. 31 dated 21.2.2013. The case was, therefore, withdrawn.

Case No. B15

M/s. Medchl Chem. & Pharma Limited File No. 01/82/50/01760/AM 11 File No. 01/82/50/00911/AM 11 File No. 01/82/50/01258/AM 11 RLA File No. 09/24/40/00539/AM 11 RLA File No. 09/24/40/00231/AM 12 RLA File No. 09/24/40/00324/AM 11 Advance Authorisaฺon No. 0910045802 dated 4.3.2011 0910048496 dated 29.8.2011 0910044428 dated 24.11.2010 Decision: It was decided to defer the case for 16.5.2013 for comments of Department of Pharmaceuticals.

Case No. B16

M/s. Metropolitan Exim Chem Limited, Mumbai 01/82/050/00532/AM 13/DES III RLA File No. 03/95/040/000290/AM 13 0310702889 dated 24.7.2012 Decision: It was decided to defer the case for 16.5.2013 for comments of Department of Chemicals and Petrochemicals.

Case No. B17

M/s. Coral Drugs Pvt. Limited 01/82/50/01398/AM 07/DES III RLA File No. 05/24/040/00739/AM 07 0510195766 dated 6.12.2006 Decision: It was decided to revise 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 Exp. Qty. Sl.No. Import items Qty. allowed Flutamide EP/BP/USP 1 kg 1. 5Amino2 Nitrobenzotrifluoride or 2 Nitro5Aminobenzotrifluoride or 4Nitro3Trifluoromethyl Aniline 1.04kg

Case No. B18

M/s. Lupin Limited 01/82/50/00417/Am 11/DES III RLA File No. 03/95/40/00127/AM 11 0310575276 dated 20.5.2010

Decision: It was decided to remind the firm to furnish the following information:  Copy of DML with approved composition for each formulated product of Cefprozil now intended to for export.  Copy of earlier approved norms for Cefprozil API received from DGFT and now shown in the calculation.  For export of 7APCA, 9 import items were allowed whereas 19 imported inputs have been shown for Cefprozil. Technical justification and policy under which additional imported inputs have been applied by the firm, for changing the export item.  Detailed working on utilization of balance quantity of 7 APCA against each of the export product now envisaged by the firm.  Requirement of 7 APCA for 1 kg Cefprozil API. The case was deferred for 16.5.2013.

Case No. B19

M/s. Panacea Biotec Limited, New Delhi 01/82/050/00427/AM 10/DES III 01/82/050/00927/AM 11/DES III 01/82/050/00327/AM 12/DES III RLA File No. 05/24/040/00156/AM 11 05/24/040/00235/AM 11 05/24/040/00070/AM 12 0510269042 dated 26.7.2010 0510274701 dated 11.10.2010 and 0510292280 dated 31.05.2011 Decision: It was decided to defer the case for comments of Department of Biotechnology.

Case No. B20

M/s. Medreich Limited, Bangalore 01/82/050/00048/AM 08/DES III RLA File No. 07/21/040/00810/AM 07 0710050467 d d 6 3 2007

0710050467 dated 6.3.2007 Decision The norms for the above mentioned license were ratified in NC meeting no. 38/08 dated 22.1.2008. At that time one of the ingredients i.e. colours were not recommended as the same was not matching with Master Batch Formula. The firm has since represented and furnished a revised Master Batch Formula’. In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/363/2012PI(Norms) dated 25.4.2013, the committee 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 Qty. Import items Qty allowed per unit of export product Paracetamol 450mg + Caffiene Anhydrous 45mg or 50 mg or 30 mg + Doxylamine Succinate 5mg + Codeine Phosphate 10mg tablets (ITC(HS)No.30049039) 1 tablet 1.Paracetamol 459mg/tab. 2.Doxylamine Succinate 5.1mg/tab. 3.Spectracolquinoline yellow 800744 B‐20 2.43 mg/tab. 4.Spectracolquinoline Yellow LK 805002 4.56 mg/tablet

Case No. B21

M/s. PI Industries Limited, Udaipur 01/82/050/00703/AM 13/DES III RLA File No. 13/24/040/00028/AM 13 1310041094 dated 20.9.2012 Decision: It was decided to defer the case for comments of Department of Chemicals and Petrochemicals.

Case No. C 1

M/s. Riocare India Private Limited, Mumbai 01/82/162/210/AM 13/DES III 01/82/050/353/AM 12/DES III Decision: The Committee deliberated upon the issue and recommended addition in the description of the export product as per details given below: SION No. Current Description of Export Product Export Description Recommended by Norms Committee A 3530 Activated Polydimethyl Siloxane Activated Polydimethyl Siloxane (Simethicone 100% USP/EP/BP) A 3529 Simethicone Simethicone (Simethicone Emulsion BP/USP/EP) . However, the NC did not agree to indicate the strength in respect of export product (SION A 3529) as the relevant inputs have been allowed based on the contents. As regards the firm’s request for change in the classification of ITC(HS) , this may be examined by Policy II. The case has already been referred to Policy II Section for consideration.

Case No. C2

M/s. Encee Aromatics Pvt. Limited 01/82/162/00745/AM 12/DES III Decision: It was decided to defer the case for comments of Department of Chemicals and Petrochemicals.

Case No.:28/2/82ALC4/2013

Party Name:BIOSTADT INDIA LIMITED Meet No/Date:2/82ALC4/2013 18 04 2013 Status:Case A

1 18.04.2013 Approved HQ File :01/82/050/00028/AM14/ RLA File :03/94/040/00259/AM09/ Lic.No/Date:0310473370 05.06.2008 Defer Date: Decision :In the light of written comments received from Department of Biotechnology vide their OM No. BT/IL/05/366/2012PID dated 8.8.2012, 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 Product Quantity Allowed ENVIRON AC (Biofixation of NIP GG and Lithothmme GG Mixture) 1 kg 1. Biofixation NIP GG 0.185 kg 2. Lithothamme GG 1.015 kg 2

Case No.:2/36/82ALC4/2009

Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 18.04.2013 Status:Case Deferred HQ File :01/82/050/00727/AM10/ RLA File :03/95/040/00485/AM10/ Lic.No/Date:0310545426 13.11.2009 Defer Date:16.05.2013 Decision :The case was deferred for 16.05.2013 for comments of Department of C&PC. 3

Case No.:26/2/82ALC4/2013

Party Name:LUPIN LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/00026/AM14/ RLA File :03/95/040/00564/AM10/ Lic.No/Date:0310549173 04.12.2009 Defer Date: 30.5.2013 Decision : It was decided to defer the case for 30.5.2013 for comments of Department of Pharmaceuticals. 4

Case No.:5/44/82ALC4/2009

Party Name:IPCA LABORATORIES LIMITED 18.04.2013 Status:Case Approved HQ File :01/82/050/00890/AM10/ RLA File :03/94/040/00809/AM10/ Lic.No/Date:0310555126 13.01.2010 Defer Date: Decision : In the light of earlier decision taken in meeting no. 10/82 dated 5.6.2012, 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 HYDROXY CHLOROQUINE SULPHATE 1 kg 1. Ethoxy Methylene Malonic Acid Ester [ EMME ] 1.1481 kg/kg 2. Metachloro Aniline 0.6756 kg/kg 3. Hydroxy Novaldiamine 0.9988 kg/kg 4 S B Toluene 0 702 kg/kg

S. B. Toluene 0.702 kg/kg 5. Methanol 2.7796 kg/kg 6. Iso Propyl Alcohol 1.49 kg/.kg 7. Methylene Chloride 2.29 kg/kg 8. Activated Carbon 0.100 kg/kg 5

Case No.:27/2/82ALC4/2013

18.04.2013 Status:Case Approved HQ File :01/82/050/00027/AM14/ RLA File :03/95/040/00704/AM10/ Lic.No/Date:0310559731 11.02.2010 Defer Date: Decision : In the light of earlier decision taken in meeting no. 18/82 dated 2.8.2011, it was decided to ratify norms under Para 4.7 of HBP v 1 as per Export Product Quantity Sl.No. Import items Quantity allowed Ethambutol HCL 1 Kg. 1. DL2 Amino Butanol 1.6014 kg 2. Tartaric Acid 0.153 kg 3. Methanol 0.562 kg 4. Isopropyl Alcohol 0.278 kg 5. Ethylene Dichloride 0.490 kg 6. Caustic Soda Flakes 0.424 kg 7. Cyclohexane 0.0056 kg 8. Calcium Hydroxide 1.4239 kg 6

Case No.:15/50/82ALC4/2009

Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 18.04.2013 Status:Case Deferred HQ File :01/82/050/01169/AM10/ RLA File :03/95/040/00779/AM10/ Lic.No/Date:0310561977 25.02.2010 Defer Date:16.05.2013 Decision :The case was deferred for 16.05.2013 for comments of Department of C&PC. 7

Case No.:16/2/82ALC4/2013

18.04.2013 Status:Case Approved HQ File :01/82/050/00016/AM14/ RLA File :03/95/040/00872/AM10/ Lic.No/Date:0310570559 21.04.2010 Defer Date: Decision : In the light of earlier decision taken in meeting no. 49/82 dated 6.3.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Export Qty. Sl.No. Import items Qty. allowed

Qty. Rifampicin 450 mg/ Capsules Rifampicin 75 mg Capsule [ Rifampicin 150 mg Capsule 1 No. 1 Sodium RIFAS 0.98 kgA/kg of Rifampicin 2. Chloroform 0.661 kg/kg of Rifampicin 3. Acetic Acid 0.16 kg/kg of Rifampicin 4. Piperazine Anhydrous 0.12 kg/kg of Rifampicin 5. Methylene Chloride 0.933 kg/kg of Rifampicin 6. Isopropyl Alcohol 0.615 kg/kg of Rifampicin 7. Dimethyl Formamide 0.80 kg/kg of Rifampicin 8. Tertiary Butyl Amine 0.314 kg/kg of Rifampicin 9. Acetone 0.832 kg/kg of Rifampicin 10. 1Amino4Methyl Piperazine 0.16 kg/kg of Rifampicin Isoniazid 300 mg Tablets 1 No. 1. Isoniazid 306 mg/tablet Isoniazid 75 mg Tablet 1 No. 1. Isoniazid 76.5 mg/tablet Isoniazid 150 mg Tablets 1 No. 1. Isoniazid 153 mg/tablet Ethambutol 600 mg Tablet [Ethambutol =612 mg/Tablet] Ethambutol 200 mg Tablet [Ethambutol =204 mg/tablet] Ethambutol =400 mg/tablet] [Ethambutol =408mg/tablet] 1 No. 1. DL2 Aminobutanol 1.6014 kg/kg of Ethambutol 2. Tartaric Acid 0.1977 kg/kg of Ethambutol 3. Methanol 0.5620 kg/kg of Ethambutol 4. Isopropyl Alcohol 0.3436 kg/kg of Ethambutol 5. Ethylene Dichloride 0.490 kg/kg of Ethambutol 6. Caustic Soda Flakes 0.4264 kg/kg of Ethambutol 7. Cyclohexane 0.0056 kg/kg of Ethambutol 8. Calcium Hydroxide 2.4525 kg/kg of Ethambutol Pyrazinamide 750 mg Tablets i id 1 No. 1. 2Cyano Pyrazine 0.952 kg/kg of Pyrazinamide

[Pyrazinamide=765 mg/tablet] Pyrazinamide 250 mg Tablets [Pyrazinamide=255 mg/tablet] Pyrazinamide 500 mg Tablets [Pyrazinamide=510 mg/tablet] Pyridoxine 5 mg Tablets [Pyridoxine=5.01mg/tablet] 1 No. 1. Pyridoxine 5.01 mg/tablet 8

Case No.:7/14/82ALC4/2010

Party Name:ARCH PHARMALABS LTD 18.04.2013 Status:Case Deferred HQ File :01/82/050/00369/AM11/ RLA File :03/94/040/01082/AM10/ Lic.No/Date:0310571324 26.04.2010 Defer Date:16.05.2013 Decision :The case was deferred for 16.05.2013 for comments of Department of Pharmaceuticals. 9

Case No.:22/6/82ALC4/2010

Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 18.04.2013 Status:Case Deferred HQ File :01/82/050/00169/AM11/ RLA File :03/95/040/00396/AM10/ Lic.No/Date:0310571937 29.04.2010 Defer Date:16.05.2013 Decision :The case was deferred for 16.05.2013 for comments of Department of Pharmaceuticals. 10

Case No.:17/2/82ALC4/2013

Party Name:WOCKHARDT LIMITED 18.04.2013 Status:Case Approved HQ File :01/82/050/00017/AM14/ RLA File :03/95/040/00083/AM11/ Lic.No/Date:0310573747 11.05.2010 Defer Date: Decision : In the light of earlier decision taken in meeting no. 21/82 dated 4.10.2012, 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 item Qty. allowed Vitamin B12 (Cyanocobalamin) USP Micronised As per particle size A) Minimum 80% Less 1 Kg. 1. Vitamin B12 Micronised Not more than 66% less 1.01 kg

) than 125 Microns B) Minimum 98% Less than 150 Microns than 125 Microns and Not more than 77% less than 150 Microns 11

Case No.:20/2/82ALC4/2013

Party Name:RELIANCE INDUSTRIES LTD. 18.04.2013 Status:Case Approved HQ File :01/82/050/00020/AM14/ RLA File :03/95/040/00189/AM11/ Lic.No/Date:0310578113 09.06.2010 Defer Date: Decision : In the light of earlier decision taken in meeting no. 13/82 dated 28.6.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Paraxylene 1 MT 1. Reformate 1.376 MT 2. Relevant Catalyst and Chemicals used in the manufacture of Paraxylene CIF value limited to 0.90% FOB value of exports RA may take appropriate action as per the decision of Norms Committee. Party to be advised to apply for fixation of SION through EPC. 12

Case No.:18/2/82ALC4/2013

Party Name:METROPOLITAN EXIMCHEM LTD. 18.04.2013 Status:Case Approved HQ File :01/82/050/00018/AM14/ RLA File :03/95/040/00126/AM11/ Lic.No/Date:0310578630 14.06.2010 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/60/2010Ch.II dated 4.3.2013, 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 5Amino 6 methyl Benzimidazolone 1 kg. 1. 3,4Diamino Toluene (Melene) 1.200 kg 13

Case No.:19/2/82ALC4/2013

18.04.2013 Status:Case Approved HQ File :01/82/050/00019/AM14/ RLA File :03/95/040/00186/AM11/ Lic.No/Date:0310578623 14.06.2010 Defer Date: Decision : In the light of earlier decision taken in meeting no. 20/82 dated 16.8.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Acrylonitrile 1 MT 1. Naphtha 1.2808 MT 2. Ammonia 0.5200 MT RA k i i h d i i f N C i

Case No.:21/2/82ALC4/2013

18.04.2013 Status:Case Approved HQ File :01/82/050/00021/AM14/ RLA File :03/95/040/00282/AM11/ Lic.No/Date:0310583253 13.07.2010 Defer Date: Decision : In the light of earlier decision taken in meeting no. 19/82 dated 9.8.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Orthoxylene 1 MT. 1. Reformate 1.2565 MT 2. Relevant Catalyst and Chemicals used in manufacture of Orthoxylene CIF value limited to 0.90% of FOB value of exports RA may take appropriate action as per the decision of Norms Committee. Party to be advised to apply for fixation of SION through EPC. 15

Case No.:22/2/82ALC4/2013

18.04.2013 Status:Case Approved HQ File :01/82/050/00022/AM14/ RLA File :03/95/040/00317/AM11/ Lic.No/Date:0310586293 06.08.2010 Defer Date: Decision : In the light of earlier decision taken in meeting no. 13/82 dated 28.6.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Paraxylene 1 MT 1. Reformate 1.376 MT 2. Relevant Catalyst and Chemicals used in the manufacture of Paraxylene CIF value limited to 0.90% FOB value of exports 16

Case No.:23/2/82ALC4/2013

Party Name:PERFECT BIOTECH 18.04.2013 Status:Case Approved HQ File :01/82/050/00023/AM14/ RLA File :03/95/040/00326/AM11/ Lic.No/Date:0310587494 13.08.2010 Defer Date: Decision : In the light of earlier decision taken in meeting no. 4/82 dated 26.4.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Soya Lecithin Powder 1 MT. 1. Soya Liquid Lecithin 1.20 MT 2. Acetone 690 Ltr. 3. Hydrogen Pexoxide 0.002 MT 4. Printed Bags 630x890 MMX 100 Microns As per packing policy

Case No.:24/2/82ALC4/2013

Party Name:WOCKHARDT LIMITED 18.04.2013 Status:Case Approved HQ File :01/82/050/00024/AM14/ RLA File :03/95/040/00359/AM11/ Lic.No/Date:0310587622 13.08.2010 Defer Date: Decision : In the light of earlier decision taken in meeting no. 21/82 dated 4.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Export Qty. Sl.No. Import item Qty. allowed Vitamin B12 Micronised A) Minimum 80% Less than 125 Microns B) Minimum 98% Less than 150 Microns 1 Kg. 1. Vitamin B12 Micronised Not more than 66% less than 125 Microns and Not more than 77% less than 150 Microns 1.01 kg 18

Case No.:7/24/82ALC4/2010

Party Name:YASHO INDUSTRIES PVT.LTD. 18.04.2013 Status:Case Approved HQ File :01/82/050/00807/AM11/ RLA File :03/95/040/00419/AM11/ Lic.No/Date:0310591096 06.09.2010 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011Ch. II dated 2.4.2013, 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 Export Qty. Sl.No. Import item Qty. allowed Dipentamethylene Thiuram Tetra Sulfide (Qureacc DPTT) 1 kg 1. Piperidine 0.466 kg 19

Case No.:15/2/82ALC4/2013

Party Name:LAKELAND CHEMICALS (INDIA) LTD. 18.04.2013 Status:Case Approved HQ File :01/82/050/00015/AM14/ RLA File :03/95/040/00456/AM11/ Lic.No/Date:0310592383 15.09.2010 Defer Date: Decision : In the light of earlier decision taken in meeting no. 46 dated 14.2.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Exp. Qty. Sl. No. Import items Qty. allowed Lakpol EI 250 (Sorbitan Mono Oleate) 1kg. 1. Oleic Acid 0.658 kg 2. Sorbitol (70%) 0.425 kg

Case No.:11/2/82ALC4/2013

18.04.2013 Status:Case Approved HQ File :01/82/050/00011/AM14/ RLA File :03/95/040/00511/AM11/ Lic.No/Date:0310595112 04.10.2010 Defer Date: Decision : In the light of earlier decision taken in meeting no. 19/82 dated 9.8.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Orthoxylene 1 MT. 1. Reformate 1.2565 MT 2. Relevant Catalyst and Chemicals used in manufacture of Orthoxylene CIF value limited to 0.90% of FOB value of exports 21

Case No.:13/2/82ALC4/2013

18.04.2013 Status:Case Approved HQ File :01/82/050/00013/AM14/ RLA File :03/95/040/00518/AM11/ Lic.No/Date:0310595097 04.10.2010 Defer Date: Decision : In the light of earlier decision taken in meeting no. 13/82 dated 28.6.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Paraxylene 1 MT 1. Reformate 1.376 MT 2. Relevant Catalyst and Chemicals used in the manufacture of Paraxylene CIF value limited to 0.90% FOB value of exports 22

Case No.:25/2/82ALC4/2013

18.04.2013 Status:Case Deferred HQ File :01/82/050/00025/AM14/ RLA File :03/95/040/00418/AM11/ Lic.No/Date:0310595268 05.10.2010 Defer Date: 16.5.2013 Decision : It was decided to defer the case for 16.5.2013 for comments of Department of Pharmaceuticals. 23

Case No.:12/2/82ALC4/2013

Party Name:WOCKHARDT LIMITED 18.04.2013 Status:Case Approved HQ File :01/82/050/00012/AM14/ RLA File :03/95/040/00517/AM11/ Lic.No/Date:0310597258 15.10.2010 Defer Date: Decision : In the light of earlier decision taken in meeting no. 21/82 dated 4.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Export Qty. Sl.No. Import item Qty. allowed Vitamin B12 Micronised 1 Kg. 1. Vitamin B12 Micronised 1.01 kg

Micronised A) Minimum 80% Less than 125 Microns B) Minimum 98% Less than 150 Microns Micronised Not more than 66% less than 125 Microns and Not more than 77% less than 150 Microns 24

Case No.:14/2/82ALC4/2013

18.04.2013 Status:Case Deferred HQ File :01/82/050/00014/AM14/ RLA File :03/95/040/00580/AM11/ Lic.No/Date:0310598211 21.10.2010 Defer Date:16.05.2013 Decision :The case was deferred for 16.05.2013 for comments of Department of Pharmaceuticals 25

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

Party Name:SAURAV CHEMICALS LTD, 18.04.2013 Status:Case Deferred HQ File :01/82/050/00990/AM11/ RLA File :22/24/040/00050/AM11/ Lic.No/Date:2210010581 28.10.2010 Defer Date:16.05.2013 Decision :Firm as well as RA was requested to furnish a copy of application . However, the same has not been received so far. It was decided to remind them to furnish a copy of application immediately. The case was deferred for 16.5.2013. 26

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

Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 18.04.2013 Status:Case Approved HQ File :01/82/050/01378/AM11/ RLA File :05/23/040/00270/AM11/ Lic.No/Date:0510280724 30.12.2010 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/337/2011PI(Norms) dated 1.4.2013, 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 Qty. Sl.No. Import item Qty. allowed 4Bromomethyl2 biphenylcarbonitrile 1 kg 1. 4methyl2cyano biphenyl (CMB) 0.785 kg 2. Hydrogen Peroxide (50%) 0.645 kg 3. Aq. Hydrogen Bromide (47%) [(Aq.Hbr (47%)] 0.813 kg 4. Dichloromethane (MDC) 0.77 kg 5. Isopropyl Alcohol (IPA) 0.45 kg

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

Party Name:MATRIX LABORATORIES LTD 18.04.2013 Status:Case Approved HQ File :01/82/050/00141/AM12/ RLA File :09/24/040/00484/AM11/ Lic.No/Date:0910045232 27 01 2011 Defer Date:

27 27.01.2011 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/126/2011PI(Norms) dated 25.4.2013, 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 Export Qty. Sl.No. Import item Qty. allowed Lopinavir (THP Route) 1 kg 1. (2S,3S,5S)2Amino3 hydroxy5(1tetra hydropyrimid2onyl)3 methyl butanoyl)amino1,6 diphenyl hexaneS pyroglutamate (THP) 1.426 kg 2. 2,6Dimethyl phenol 0.618 kg 3. Dimethyl Formamide 0.007 kg 4. Methylene dichloride 3.17 kg 5. Toluene 5.32 kg 28

Case No.:29/2/82ALC4/2013

Party Name:MERCK LIMITED 18.04.2013 Status:Case Approved HQ File :01/82/050/00030/AM14/ RLA File :03/95/040/00979/AM11/ Lic.No/Date:0310620575 10.03.2011 Defer Date: Decision : In the light of earlier decision taken in meeting no. 14/82 dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Thiamine Disulfide 1 Kg. 1. Thiamine Hcl IP/BP/USP (Vit.B1 Hcl) 1.4199 kg 2. Sodium Hydroxide Pellets 0.4634 kg 3. Potassium hexacyanoferate III GR 0.0022 kg 4. Hydrochloric Acid Fuming 37% 0.3356 kg 5. Hydrogen Peroxide Solution 35% extra pure 0.2157 kg 6. Acetone 0.8702 Ltr. 29

Case No.:3/2/82ALC4/2013

Party Name:MEHTA (API) PVT.LTD 18.04.2013 Status:Case Approved HQ File :01/82/050/00003/AM14/ RLA File :03/95/040/00982/AM11/ Lic.No/Date:0310620569 10.03.2011 Defer Date: Decision : In the light of earlier decision taken in meeting no. 46/82 dated 15.2.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Des Azithromycin/Desmethyl Azithromycin CAS Registry No.76801859 1 Kg. 1. Erythromycin Thiocynate 1.640 KGA 2. Hydroxyamine Hydrochloride 0.87 kg 3. Para Toluene Sulfonyl Chloride 0.407 kg 4. Methanol 3.00 kg 5. Methylene Chloride/Acetone 1.27 kg 6 5% Platinum on Charcoal 0 00105 kg

5% Platinum on Charcoal 0.00105 kg 30

Case No.:5/2/82ALC4/2013

18.04.2013 Status:Case Approved HQ File :01/82/050/00005/AM14/ RLA File :03/95/040/00984/AM11/ Lic.No/Date:0310620941 14.03.2011 Defer Date: Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/152/2010PI(Norms) dated 25.11.2010, 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 Levetiracetam 1 kg 1. Ethyl Acetate 1.49 kg 2. Methanol 0.71 kg 3. Methylene Chloride 3.74 kg 4. Methyl 2 Bromo Butyrate 2.9117 kg 5. Potassium Carbonate 1.0925 kg 6. L(+) Tartaric Acid 0.87 kg 7. Methanol 7.2656 kg 8. Caustic Soda Lye 0.4892 kg 9. Iso Propyl Alcohol 1.3119 kg 10. Activated Carbon 0.0384 kg 31

Case No.:6/2/82ALC4/2013

18.04.2013 Status:Case Approved HQ File :01/82/050/00006/AM14/ RLA File :03/95/040/00992/AM11/ Lic.No/Date:0310620945 14.03.2011 Defer Date: Decision : In the light of earlier decision taken in meeting no. 18/82 dated 2.8.2011, it was decided to ratify norms under Para 4.7 of HBP v 1 as per Export Product Quantity Sl.No. Import items Quantity allowed Ethambutol HCL 1 Kg. 1. DL2 Amino Butanol 1.6014 kg 2. Tartaric Acid 0.153 kg 3. Methanol 0.562 kg 4. Isopropyl Alcohol 0.278 kg 5. Ethylene Dichloride 0.490 kg 6. Caustic Soda Flakes 0.424 kg 7. Cyclohexane 0.0056 kg 8. Calcium Hydroxide 1.4239 kg

Case No.:2/2/82ALC4/2013

Party Name:WOCKHARDT LIMITED 18.04.2013 Status:Case Approved HQ File :01/82/050/00002/AM14/ RLA File :03/95/040/00967/AM11/ Lic.No/Date:0310622511 22.03.2011 Defer Date: Decision : In the light of earlier decision taken in meeting no 21/82 dated 4 10 2012 it was decided to ratify norms under Para 4 7 of HBP v1 as

32 Decision : In the light of earlier decision taken in meeting no. 21/82 dated 4.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Export Qty. Sl.No. Import item Qty. allowed Vitamin B12 Micronised A) Minimum 80% Less than 125 Microns B) Minimum 98% Less than 150 Microns 1 Kg. 1. Vitamin B12 Micronised Not more than 66% less than 125 Microns and Not more than 77% less than 150 Microns 1.01 kg RA may take appropriate action as per the decision of Norms Committee 33

Case No.:7/2/82ALC4/2013

18.04.2013 Status:Case Approved HQ File :01/82/050/00007/AM14/ RLA File :03/95/040/01034/AM11/ Lic.No/Date:0310623274 25.03.2011 Defer Date: Decision : In the light of earlier decision taken in meeting no. 18/82 dated 2.8.2011, it was decided to ratify norms under Para 4.7 of HBP v 1 as per Export Product Quantity Sl.No. Import items Quantity allowed Ethambutol HCL 1 Kg. 1. DL2 Amino Butanol 1.6014 kg 2. Tartaric Acid 0.153 kg 3. Methanol 0.562 kg 4. Isopropyl Alcohol 0.278 kg 5. Ethylene Dichloride 0.490 kg 6. Caustic Soda Flakes 0.424 kg 7. Cyclohexane 0.0056 kg 8. Calcium Hydroxide 1.4239 kg 34

Case No.:8/2/82ALC4/2013

Party Name:SUPREET CHEMICALS PVT.LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/00008/AM14/ RLA File :03/95/040/01043/AM11/ Lic.No/Date:0310623747 28.03.2011 Defer Date:16.05.2013 Decision :The case was deferred for 16.05.2013 for comments of Department of C&PC 35

Case No.:10/2/82ALC4/2013

Party Name:RATNAGIRI CHEMICALS PVT. LTD. 18.04.2013 Status:Case Approved HQ File :01/82/050/00010/AM14/ RLA File :03/95/040/01053/AM11/ Lic.No/Date:0310624772 01.04.2011 Defer Date: Decision : In the light of earlier decision taken in meeting no. 44/82 dated 1.2.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per

Export product Exp. Qty. Sl.No. Import items Qty. allowed Hydroquinone Monomethyl Ether (Purity Min.99.5%) 1 kg 1. Hydroquinone 1.11 kg 2. Para Benzoquinone 0.15 kg 36

Case No.:9/2/82ALC4/2013

Party Name:SUPREET CHEMICALS PVT.LTD. 18.04.2013 Status:Case Approved HQ File :01/82/050/00009/AM14/ RLA File :03/95/040/01052/AM11/ Lic.No/Date:0310625304 06.04.2011 Defer Date: Decision : In the light of earlier decision taken in meeting no. 40/82 dated 4.1.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Exp. Qty. Sl.No. Import items Qty. allowed 5Acetamido2Amino Benzotrifluoride 1 Kg. 1. 3Amino Benzo Trifluoride 1.172 kg 37

Case No.:31/2/82ALC4/2013

Party Name:SUPREET CHEMICALS PVT.LTD. 18.04.2013 Status:Case Approved HQ File :01/82/050/00032/AM14/ RLA File :03/95/040/00013/AM12/ Lic.No/Date:0310625975 11.04.2011 Defer Date: Decision : In the light of earlier decision taken in meeting no. 44/82 dated 1.2.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Acid Blue 277 (ABR Acid or SP 92 or Acid BlueRR) 1 Kg. 1. Bromamine Acid 1.160 kg 2. 3,4Dimethyl Nitro Benzene (4 NOX or 3,4Nitro Xylene) 0.340 kg 38

Case No.:32/2/82ALC4/2013

18.04.2013 Status:Case Approved HQ File :01/82/050/00033/AM14/ RLA File :03/95/040/00028/AM12/ Lic.No/Date:0310626805 15.04.2011 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011Ch. II dated 2.4.2013, 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 Copper Dibutyl Dithiocarbamate (CDBC) 1 kg 1. DINButylamine (Dibutylamine) 0.600 kg 39

Case No.:4/2/82ALC4/2013

Party Name:METROPOLITAN EXIMCHEM LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/00004/AM14/ RLA File :03/95/040/00983/AM11/ Lic No/Date:0310626783 Defer

39 HQ File :01/82/050/00004/AM14/ RLA File :03/95/040/00983/AM11/ Lic.No/Date:0310626783 15.04.2011 Defer Date:16.05.2013 Decision :The case was deferred for 16.05.2013 for comments of Department of C&PC 40

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

Party Name:AUROBINDO PHARMA LIMITED 18.04.2013 Status:Case Approved HQ File :01/82/050/00206/AM12/ RLA File :09/24/040/00032/AM12/ Lic.No/Date:0910046590 02.05.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/190./2011PI(Norms) dated 25.4.2013, 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 (kg/kg) Ritonavir 1 kg 1 CARBONIC ACID4NITROPHENYL5 THIAZOLYLMETHYLESTER (NCT) 0.72 2 THIONYL CHLORIDE 0.768 3 4DIMETHYL AMINO PYRIDINE 0.068 4 METHANESULFONIC ACID 2.229 5 MONOETHYLENE GLYCOL DIMETHYL ETHER (MONOGLYME) 10.415 6 nHEPTANE 2.22 7 TRIETHYLAMINE 0.341 8 TRIFLUOROACETIC ACID 2.167 9 IODINE 0.001 10 LPHENYL ALANINE 0.853 11 ANHYDROUS POTASSIUM CARBONATE 3.72 12 SODIUM BOROHYDRIDE 0.79 13 DITERTIARYBUTYL DICARBONATE 0.773 14 CARBON ENOANTICROMOS [ ACTIVATED CARBON ] 0.0368 15 ACETONE 0.698 16 ACETONITRILE 0.329 17 HEXANES 0.488 18 ISOPROPYL ALCOHOL 0.83 19 METHANOL 6.25 20 METHYLENE CHLORIDE 11.70 21 n HEXANE 3.49 22 TETRAHYDROFURAN [ THF ] 3.54

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

Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:2/82ALC4/2013 18.04.2013 Status:Case Approved HQ File :01/82/050/00369/AM12/ RLA File :34/24/040/00016/AM12/ Lic.No/Date:3410030199 12.05.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/604/2012PI(Norms) dated 6 2 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:

41 6.2.2013, 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 (kg/kg) Candesartan Cilexetil 1 kg 1. 2Ethoxy1[2{1 HTetrazole5 yl}Biphenyl4yl)Methyl] Benzimidazole7Carboxylic Acid (EBCIII) 1.35 2. Triethyl amine 0.31 3. Acetone 4.32 4. Methanol 4.58 5. Methylene Chloride (or Dichloromethane) 6.88 6. 1chloroethyl cyclohexyl carbonate 0.49 7. Dimethyl Formamide 0.83 8. Cyclohexane 2.06 42

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

Party Name:FDC LTD 18.04.2013 Status:Case Deferred HQ File :01/82/050/00438/AM12/ RLA File :03/94/040/00152/AM12/ Lic.No/Date:0310637790 22.06.2011 Defer Date:16.05.2013 Decision :The case was deferred for 16.05.2013 for comments of Department of Pharmaceuticals 43

Case No.:25/26/82ALC4/2011

Party Name:ENCUBE ETHICALS PVT LTD 18.04.2013 Status:Case Deferred HQ File :01/82/050/00708/AM12/ RLA File :03/94/040/00385/AM12/ Lic.No/Date:0310646711 05.08.2011 Defer Date:16.05.2013 Decision :Reply received from the firm sent to Department of Pharmaceuticals. Accordingly, the case was deferred for 16.05.2013 for comments of Department of Pharmaceuticals 44

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

Party Name:GRANULES INDIA LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/00919/AM12/ RLA File :09/24/040/00239/am 12 Lic.No/Date:0910048379 DATED 25.8.2011 Defer Date:16.05.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/697/2012PI(Norms) dated 1.4.2013, it was decided to remind the firm to furnish a copy of Drug Manufacturing License along with list of approved items with their composition. The case was deferred for 16.5.2013. 45

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

Party Name:CADILA HEALTHCARE LTD., 18.04.2013 Status:Case Approved

HQ File :01/82/050/01026/AM12/ RLA File :08/24/040/00179/AM12/ Lic.No/Date:0810105257 08.11.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/393/2012PI(Norms) dated 25.4.2013, 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 Metformin HCL ER500 Mg Tabs 1 tablet 1. Metformin HCL BP 510.0 mg 2. Hypromellose USP (Methocel K 15 M) 400.0 mg 3. Povidone K 90 USP 66.0 mg 4. Microcrystalline Cellulose (Avicel PH 101) 51.0 mg 5. Bottles and Caps (Packing material in finished form) a. 950 CC White HDPE Bottle Relevant, as per packing policy 6. NCRC white cap 53 MM Metformin HCL ER 750 mg tables (Active Ingredient Metformin HCL 71604.75 kgs) 1 tablet 1 Metformin HCL BP 765.0 mg 2 Hypromellose USP (Methocel K 15 M) 220.0 mg 3 Povidone K 90 USP 30.0 mg 4 Microcrystalline Cellulose (Avicel PH 101) 100.0 mg 5 Bottles and Caps (Packing material in finished form) a. 950 CC White HDPE Bottle Relevant, as per packing policy 6 NCRC white cap 53 MM 46

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

Party Name:SANO MEDICAL KITS PVT. LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/01184/AM12/ RLA File :04/24/040/00244/am 12/ Lic.No/Date:0410131205 DATED 1.12.20111 Defer Date:16.05.2013 Decision :Department of Industrial Policy and Promotion vide their U.O No. 7/88/2013TSW/52 dated 15.4.2013 has communicated that license may be ratified as applied for. The Committee deliberated upon the comments given by the DIPP and decided to request the Department of Industrial Policy and Promotion to furnish the wastage in each import item separately. The case was deferred for 16.5.2013.

Case No.:2/39/82ALC4/2011

Party Name:BILCARE LIMITED 18.04.2013 Status:Case Rejected HQ File :01/82/050/00994/AM12/ RLA File :31/83/040/00167/AM12/ Lic.No/Date:3110051868 13.12.2011 Defer Date: Decision :It was decided to close the case and will reopen when the firm will come for Personal hearing. 48

Case No.:38/3/82ALC4/2012

Party Name:BROOKS LABORATORIES LTD., 18.04.2013 Status:Case Deferred HQ File :01/82/050/00042/AM13/ RLA File :22/24/040/00068/AM12/ Lic.No/Date:2210012375 29.12.2011 Defer Date:16.05.2013 Decision :It was decided to defer the case for 16.05.2013 or comments of D/o Pharmaceuticals 49

Case No.:41/1/82ALC4/2012

Party Name:VIVIMED LABS LIMITED 18.04.2013 Status:Case Approved HQ File :01/82/050/01483/AM12/ RLA File :09/24/040/00459/AM12/ Lic.No/Date:0910050480 29.12.2011 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/138/2011Ch II dated 4.4.2013, 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 Reversacol Heather 1 kg 1. 4,4 Dimethoxy Benzophenone 3.100 kg 2. Tolune 17.350 kg 3. THF (Tetra Hydro Furan) 9.205 kg 4. 4Fluro4Methyl Benzophenone 1.050 kg 5. Pyrrolidine 1.100 kg 6. PuralMG70 0.260 kg 7. TMSA (Tri Methyl Silyl Acetylene) 0.710 kg 8. Methanol 27.630 kg 50

Case No.:3/41/82ALC4/2011

Party Name:RUSAN PHARMA LTD. 18.04.2013 Status:Case Approved HQ File :01/82/050/01004/AM12/ RLA File :03/95/040/00803/AM12/ Lic.No/Date:0310673724 30.12.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/82/2013PI(Norms) dated 1.4.2013, 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 Bisoprolol Fumarate 1 kg 1. 1[4[[2(1 Methylethoxy)Ethoxy]Methyl]Phenoxy]3 [(1Methylethyl)Amino]2Propanol (Technical) 1.00 kg RA may take appropriate action as per the decision of Norms Committee

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

Party Name:INCHEM LABORATORIES PRIVATE LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/00017/AM13/ RLA File :09/24/040/00467/AM12/ Lic.No/Date:0910050600 03.01.2012 Defer Date:16.05.2013 Decision :Reply received from the firm was sent to Department of Pharmaceuticals. The case was deferred for the comments of Department of Pharmaceuticals. 52

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

Party Name:S.R.S.PHARMACEUTICALS PVT. LTD. 18.04.2013 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:16.05.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/112/2013PI(Norms) dated 1.4.2013, it was decided to call from the firm a copy of Drug Manufacturing License alongwith list of approved items showing composition of export product from the firm. The case was deferred for 16.5.2013. 53

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

Party Name:VINDHYA PHARMA (INDIA)PVT LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/00060/AM13/ RLA File :09/24/040/00494/AM12/ Lic.No/Date:0910051044 31.01.2012 Defer Date:16.05.2013 Decision :It was decided to defer the case for 16.05.2013 for comments of Department of Pharmaceuticals. 54

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

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/00135/AM13/ RLA File :03/95/040/00886/AM12/ Lic.No/Date:0310681867 14.02.2012 Defer Date:16.05.2013 Decision :It was decided to remind the firm to furnish the technical details as per Appendix 33 without any further delay otherwise their case would be closed. The case was deferred for 16.05.2013. 55

Case No.:26/4/82ALC4/2012

18.04.2013 Status:Case Rejected HQ File :01/82/050/00106/AM13/ RLA File :03/94/040/01048/AM12/ Lic.No/Date:0310683210 23.02.2012 Defer Date: Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders and also did not attend the PH. 56

Case No.:14/4/82ALC4/2012

18.04.2013 Status:Case Approved HQ File :01/82/050/00094/AM13/ RLA File :03/94/040/01044/AM12/ Lic.No/Date:0310683238 Defer Date:

24.02.2012 Decision : In the light of earlier decision taken in meeting no.21/82 dated 4.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export Product Export Quantity S.No Import Product Quantity Allowed (4RCis)1,1 dimethylethyl6cyano methyl2, 2dimthyl1, 3 dioxane4acetate ATS8 1 kg 1. Ethyl R4Cyano3 Hydroxy Butanoate 0.82 kg 2. nButyl Lithium in Hexane 30.0% 0.95 kg 3. Tertiary Butyl Acetate 2.11 kg 4. Tetrahydrofuran (THF) 4.10 kg 5. Lyophilised Enzyme Powder CDX 041 0.0125 kg 6. Lyophilised Enzyme Powder CDX 901 0.0045 kg 7. NADPSP, CoenzymeII 0.0009 kg 8. 2,2Dimethoxy Propane 1.79 kg 57

Case No.:88/4/82ALC4/2012

Party Name:VIVIMED LABS LIMITED 18.04.2013 Status:Case Approved HQ File :01/82/050/00168/AM13/ RLA File :09/24/040/00601/AM12/ Lic.No/Date:0910051490 28.02.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/138/2011Ch. II dated 4.4.2013, 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 Product Quantity Allowed Hydroxy MethylMethyl Phenidone (HMP) 1 kg 1. Dimethylol Propionic Acid DMPA 1.203 kg 2. Phenyl Hydrazine (PH) 0.928 kg 3. Methanol 0.411 kg 4. Toluene 0.928 kg 5. Amberlyst (Resin) 0.171 kg

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

18 04 2013 Status:Case D f d

58 18.04.2013 Deferred HQ File :01/82/050/00102/AM13/ RLA File :03/94/040/01067/AM12/ Lic.No/Date:0310684092 29.02.2012 Defer Date:16.05.2013 Decision :It was decided to defer the case for 16.05.2013 for comments of Department of Pharmaceuticals 59

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

18.04.2013 Status:Case Rejected HQ File :01/82/050/00036/AM13/ RLA File :03/94/040/01066/AM12/ Lic.No/Date:0310684076 29.02.2012 Defer Date: Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders and also did not attend the PH 60

Case No.:60/49/82ALC4/2011

18.04.2013 Status:Case Approved HQ File :01/82/050/01369/AM12/ RLA File :03/94/040/00125/AM12/ Lic.No/Date:0310683824 29.02.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/150/2013PI(Norms) dated 25.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed Zidovudine USP from Azido Compound 1 kg 1. 1(4Azido5 Trityloxymethyl Tetrahydrofuran2 yl)5methyl1H Pyrimidine2,4diione (Azido Compound) 2.00 kg 61

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

18.04.2013 Status:Case Rejected HQ File :01/82/050/00105/AM13/ RLA File :03/94/040/01078/AM12/ Lic.No/Date:0310684488 02.03.2012 Defer Date: Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders and also did not attend the PH 62

Case No.:33/4/82ALC4/2012

18.04.2013 Status:Case Rejected HQ File :01/82/050/00113/AM13/ RLA File :03/94/040/01099/AM12/ Lic.No/Date:0310684919 05.03.2012 Defer Date: Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders and also did not attend the PH

Case No.:34/4/82ALC4/2012

18.04.2013 Status:Case Deferred HQ File :01/82/050/00114/AM13/ RLA File :03/94/040/01077/AM12/ Lic.No/Date:0310684930 05.03.2012 Defer Date:16.05.2013 64

Case No.:28/4/82ALC4/2012

18.04.2013 Status:Case Rejected HQ File :01/82/050/00108/AM13/ RLA File :03/94/040/01102/AM12/ Lic.No/Date:0310684966 06.03.2012 Defer Date: Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders and also did not attend the PH 65

Case No.:29/4/82ALC4/2012

18.04.2013 Status:Deffered HQ File :01/82/050/00109/AM13/ RLA File :03/94/040/01104/AM12/ Lic.No/Date:0310684961 06.03.2012 Defer Date:16.05.2013 Decision : It was decided to defer the case for 16.5.2013 for comments of Department of Pharmaceuticals. 66

Case No.:31/4/82ALC4/2012

18.04.2013 Status:Case Rejected HQ File :01/82/050/00111/AM13/ RLA File :03/94/040/01101/AM12/ Lic.No/Date:0310684973 06.03.2012 Defer Date: Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders and also did not attend the PH 67

Case No.:41/4/82ALC4/2012

18.04.2013 Status:Case Rejected HQ File :01/82/050/00121/AM13/ RLA File :03/94/040/01105/AM12/ Lic.No/Date:0310684976 06.03.2012 Defer Date: Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders and also did not attend the PH 68

Case No.:1/2/82ALC4/2012

Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 18.04.2013 Status:Case Deferred HQ File :01/82/050/00001/AM13/ RLA File :03/95/040/00970/AM12/ Lic.No/Date:0310688849 30.03.2012 Defer Date:16.05.2013 Decision :It was decided to give a final reminder to the firm to furnish a copy of Mater batch Formula duly certified by Quality control Incharge. The case was deferred for 16.05.2013

Case No :36/11/82 ALC4/2012

Party Name:LAKE CHEMICALS PRIVATE Meet No/Date:2/82 ALC4/2013 Status:Case

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

Party Name:LAKE CHEMICALS PRIVATE LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/00303/AM13/ RLA File :07/24/040/00004/AM13/ Lic.No/Date:0710087698 16.04.2012 Defer Date:16.05.2013 Decision :It was decided to remind the firm to furnish a copy of complete set of technical details as per Appendix 33. The case was deferred for 16.05.2013 70

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

Party Name:HETERO LABS LIMITED 18.04.2013 Status:Case Approved HQ File :01/82/050/00513/AM13/ RLA File :09/24/040/00034/AM13/ Lic.No/Date:0910052325 25.04.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/14/2012PI(Norms) dated 25.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed Bicalutamide 1 kg 1. 4Amino2Trifluoro MethylBenzonitrile 1.395 kg 2. PFluoro Thiophenol 0.50 kg 3. Tetrahydrofuran 1.04 kg 71

Case No.:59/1/82ALC4/2013

Party Name:ALKALOIDS CORPORATION 18.04.2013 Status:Case Approved HQ File :01/82/050/01417/AM13/ RLA File :02/24/040/00002/AM13/ Lic.No/Date:0210177059 30.04.2012 Defer Date: Decision : Withdrawn as the case was already approved in 1/82 meeting dated 4.4.2013. 72

Case No.:13/1/82ALC4/2013

Party Name:DSM ANTIINFECTIVES INDIA LTD 18.04.2013 Status:Case Approved HQ File :01/82/050/01371/AM13/ RLA File :22/21/040/00024/AM13/ Lic.No/Date:2210012792 02.05.2012 Defer Date: Decision : Withdrawn as the case was already approved in 1/82 meeting dated 4.4.2013. 73

Case No.:46/14/82ALC4/2012

Party Name:ENCUBE ETHICALS PVT LTD 18.04.2013 Status:Case Deferred HQ File :01/82/050/00423/AM13/ RLA File :03/94/040/00188/AM13/ Lic.No/Date:0310697620 06.06.2012 Defer Date:16.05.2013 Decision : The firm was requested to furnish Master Batch Formula. However, the firm has submitted a copy of Certificate of Pharmaceutical product. A copy of COP was sent to Department of Pharmaceuticals for examination. The case was deferred for 16.5.2013 for comments of Department of Pharmaceuticals.

Department of Pharmaceuticals. 74

Case No.:53/14/82ALC4/2012

Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/00430/AM13/ RLA File :03/94/040/00888/AM12/ Lic.No/Date:0310697981 08.06.2012 Defer Date:16.05.2013 Decision :it was decided to remind the firm to furnish following technical details: • Complete and balanced chemical reaction at each stage showing correct molecular weight of each input and their molar requirement. • Chemical description of intermediates formed in the process and their molecular weight. • % yield on molar basis for each step of manufacturing process. • Copy of technical literature in support of yields envisaged and molar requirement of each input. The case was deferred for 16.05.2013. 75

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

Party Name:STERICON PHARMA PVT.LTD., 18.04.2013 Status:Case Deferred HQ File :01/82/050/00579/AM13/ RLA File :07/24/040/00108/AM13/ Lic.No/Date:0710088798 13.06.2012 Defer Date:16.05.2013 Decision :it was decided to remind the firm to furnish following technical details: DML for the export item no. 2 & 3 as the same is not found in the approved list of DML furnished by them. The case was deferred for 16.05.2013. 76

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

Party Name:INDSWIFT LABORATORIES LTD., 18.04.2013 Status:Case Deferred HQ File :01/82/050/00802/AM13/ RLA File :22/24/040/00012/AM13/ Lic.No/Date:2210013015 14.06.2012 Defer Date:16.05.2013 77

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

Party Name:BILCARE LIMITED 18.04.2013 Status:Case Rejected HQ File :01/82/050/00582/AM13/ RLA File :31/83/040/00051/AM13/ Lic.No/Date:3110054688 15.06.2012 Defer Date: Decision :It was decided to close the case and will reopen when the firm will come for Personal hearing 78

Case No.:3/12/82ALC4/2012

Party Name:BILCARE LIMITED 18.04.2013 Status:Deffered and Reindexed HQ File :01/82/050/00333/AM13/ RLA File :31/83/040/00057/AM13/ Lic.No/Date:3110054717 18.06.2012 Defer Date:18.04.2013 Decision :It was decided to close the case and will reopen when the firm will come for Personal Hearing

Decision :It was decided to close the case and will reopen when the firm will come for Personal Hearing. 79

Case No.:109/18/82ALC4/2012

Party Name:FRESENIUS KABI ONCOLOGY LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/00604/AM13/ RLA File :05/23/040/00491/AM12/ Lic.No/Date:0510328334 27.06.2012 Defer Date: 16.05.2013 80

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

Party Name:ASCENT FINECHEM PVT. LTD., 18.04.2013 Status:Case Approved HQ File :01/82/050/00510/AM13/ RLA File :08/24/040/00112/AM13/ Lic.No/Date:0810113196 09.07.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/1/2012Ch. II dated 1.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed Tyramine Base White to off white powder 1 kg 1. Para Cresol Colourless Liquid 3.01 kg 2. Sodium Cyanide White Powder/Tablets 0.929 kg 3. Hydrobromic Acid 48% Colourless Liquid 1.89 kg 81

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

Party Name:SWISS PARENTERALS PVT.LTD. 18.04.2013 Status:Case Approved HQ File :01/82/050/00500/AM13/ RLA File :08/24/040/00122/AM13/ Lic.No/Date:0810113430 17.07.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/647/2012PI(Norms) dated 12.3.2013, 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 Export Quantity S.No Import Product Quantity Allowed 40 mg 500 mg Methyl Prednisolone Sodium Succinate for Inj. USP 40 mg & 500 mg 1 no. of vial 1. Methyl Prednisolone Sodium Succinate USP 55.688 mg 696.0 mg

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

Party Name:INTAS PHARMACEUTICALS LTD., 18.04.2013 Status:Case Deferred HQ File :01/82/050/00530/AM13/ RLA File :08/24/040/00128/AM13/ Lic.No/Date:0810113566 20.07.2012 Defer Date:16.05.2013 Decision :it was decided to remind the firm to furnish complete technical details as per Appendix 33. The case was deferred for 16.05.2013. 83

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

Party Name:SATYADEVA PHARMACEUTICALS /P/ LTD., 18.04.2013 Status:Case Deferred HQ File :01/82/050/00691/AM13/ RLA File :09/24/040/00184/AM13/ Lic.No/Date:0910053311 20.07.2012 Defer Date:16.05.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/31/2013PI(Norms) dated 1.4.2013, it was decided to call from the firm the complete technical details as per Appendix 33. The case was deferred for 16.5.2013. 84

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

Party Name:RONAK CHEMICALS 18.04.2013 Status:Case Approved HQ File :01/82/050/00543/AM13/ RLA File :34/24/040/00109/AM13/ Lic.No/Date:3410034708 23.07.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/5/2013Ch. II dated 12.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed Barbituric Acid 1 kg 1. DiEthyl Malonate 1.46 kg 2. Sodium Metal 0.179 kg 85

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

Party Name:ANUH PHARMA LTD. 18.04.2013 Status:Case Approved HQ File :01/82/050/00641/AM13/ RLA File :03/94/040/00293/AM13/ Lic.No/Date:0310703076 25.07.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/16/2013PI(Norms) dated 1.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed Erythromycin Stearate Granules 86% w/w (Direct compressible into tablets as per USP 23) 1 kg 1. Erythromycin Thiocyanate 0.5385 KGA/kg 86

Case No :27/21/82 ALC4/2012

Part Name:STELLENCE PHARMSCIENCE PVT Meet No/Date:2/82 ALC4/2013 Status:Case

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

Party Name:STELLENCE PHARMSCIENCE PVT LTD 18.04.2013 Status:Case Deferred HQ File :01/82/050/00657/AM13/ RLA File :07/24/040/00183/AM13/ Lic.No/Date:0710089972 31.07.2012 Defer Date:16.05.2013 Decision : It was decided to remind the firm to furnish the following details: Complete technical details as per Appendix 33. End use of the export product. It was decided to defer the case for 16.05.2013. 87

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

Party Name:PADMINI AROMATICS 18.04.2013 Status:Case Deferred HQ File :01/82/050/00665/AM13/ RLA File :07/24/040/00177/AM13/ Lic.No/Date:0710090045 03.08.2012 Defer Date:16.05.2013 Decision : It was decided to remind the firm to furnish production consumption data duly verified by Central Excise Authority. Department of Chemicals and Petrochemicals also to give comments whether the export product is perfume or perfumery compound. The case was deferred for 16.5.2013 88

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

Party Name:AUCTUS Pharma Limited 18.04.2013 Status:Case Approved HQ File :01/82/050/00725/AM13/ RLA File :09/24/040/00206/AM 13/ Lic.No/Date:0910053463 dated 9.8.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/709/2012PI(Norms) dated 1.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed Clopidogrel Hydrochloride 1 kg 1. 2Thiophene ethylamine (or) thiophene2Ethyl Amine 1.76 kg 2. L() Camphor Sulphonic Acid 0.828 kg 3. Methylene Di Chloride (MDC) 7.62 kg

Case No.:44/22/82ALC4/2012

18.04.2013 Status:Case Approved HQ File :01/82/050/00747/AM13/ RLA File :03/94/040/00347/AM13/ Lic.No/Date:0310704825 10.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/38/2013PI(Norms) dated 1.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed (s)2 ((methoxycarbonyl)amino)3,3 dimethylbutanoic acid (L MOCTLeucine) 1 kg 1. Trimethyl Pyruvic acid 0.95 kg 2. Lyophilised Enzyme Powder CDX012 3.10 gm/kg 3. Lyophilised Enzyme Powder CDX013 8.65 gm/kg 4. BNicotinamideadenine Dinucloetide Oxidised Form (NADG3) 4.66 gm/kg 90

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

Party Name:INCHEM LABORATORIES PRIVATE LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/00695/AM13/ RLA File :09/24/040/00239/AM13/ Lic.No/Date:0910053490 14.08.2012 Defer Date:16.05.2013 Decision :Reply received from the firm sent to Department of Pharmaceuticals. The case was deferred for the comments of Department of Pharmaceuticals. 91

Case No.:24/22/82ALC4/2012

Party Name:HETERO LABS LIMITED 18.04.2013 Status:Case Approved HQ File :01/82/050/00727/AM13/ RLA File :09/24/040/00174/AM13/ Lic.No/Date:0910053519 16.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/12/2013PI(Norms) dated 1.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed Rosuvastatin Calcium 1 kg 1. 5Bromomethyl4 fluorophenyl6isopropryl2 methyl methyl sulfonyl amino pyridine 2.20 kg 2. Tertiary butyl (4R, CIS)6 acetoxymethyl2,2 1.683 kg

dimethyl1,3dioxane4 acetate 3. Acetonitrile 5.238 kg 4. Tertiary butyl acetate 1.40 kg 92

Case No.:65/22/82ALC4/2012

18.04.2013 Status:Case Approved HQ File :01/82/050/00768/AM13/ RLA File :03/94/040/00380/AM13/ Lic.No/Date:0310705390 16.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/39/2013PI(Norms) dated 1.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed 6(3tert butyl)5(2,4dioxo3,4 dihydropyrimidin1(2H) yl)2methoxyphenyl)naphthalene 2yl I, 1,2,2,3,3,4,4,4 nonafluorobutane1sulfonate Nonaflate (A1204533.0) 1 kg 1. Phosphine Ligand (1,3,5,7Tetramethyl 2,4,8trioxa6phenyl6 phosphaadamantane) 0.016 kg 2. LCysteine 0.1036 kg 3. Perfluoro Butanesulfonyl Fluoride 0.4064 kg 93

Case No.:25/22/82ALC4/2012

Party Name:GRANULES INDIA LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/00728/AM13/ RLA File :09/24/040/00250/AM13/ Lic.No/Date:0910053546 17.08.2012 Defer Date:16.05.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/669/2012PI(Norms) dated 12.3.2013, it was decided to call from the firm the complete technical details as per Appendix 33. The case was deferred for 16.5.2013. 94

Case No.:27/22/82ALC4/2012

Party Name:GRANULES INDIA LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/00730/AM13/ RLA File :09/24/040/00249/AM13/ Lic.No/Date:0910053547 17.08.2012 Defer Date:16.05.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/669/2012PI(Norms) dated 12.3.2013, it was decided to call from the firm the complete technical details as per Appendix 33. The case was deferred for 16.5.2013. 95

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

Party Name:VITAL LABORATORIES PVT. LTD. 18.04.2013 Status:Case Deferred HQ Fil 01/82/050/00670/AM13/ RLA Fil 03/95/040/00254/AM13/ Li N /D 0310705409 D f

HQ File :01/82/050/00670/AM13/ RLA File :03/95/040/00254/AM13/ Lic.No/Date:0310705409 17.08.2012 Defer Date:16.05.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/28/2013PI(Norms) dated 1.4.2013, it was decided to call from the firm the complete technical details as per Appendix 33. The case was deferred for 16.5.2013. 96

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

Party Name:MEDLEY PHARMACEUTICALS LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/00671/AM13/ RLA File :03/95/040/00273/AM13/ Lic.No/Date:0310705411 17.08.2012 Defer Date:16.05.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/681/2012PI(Norms) dated 1.4.2013, it was decided to call from the firm a copy of DML for the export product. The case was deferred for 16.5.2013. 97

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

Party Name:VASUDHA PHARMA CHEM LTD 18.04.2013 Status:Case Approved HQ File :01/82/050/00692/AM13/ RLA File :09/24/040/00204/AM13/ Lic.No/Date:0910053534 17.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/23/2013PI(Norms) dated 1.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed Losartan Potassium (or) Losartan Potassium USP 1 kg 1. Methanol 0.51 kg 2. Toluene 0.59 kg 3. 1,3Dibromo5,5Dimethyl Hydantoin 0.205 kg 4. 2(nButyl)4Chloro5 Formyl Imidazole 0.50 kg 5. 2Cyano4Methyl Biphenyl 0.68 kg 6. Chloroform 1.20 kg 7. Sodium Borohydride 0.048 kg 8. Tri Ethyl Amine 0.196 kg 98

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

Party Name:ECOLOGIC CHEMICALS LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/00694/AM13/ RLA File :09/24/040/00199/AM13/ Lic.No/Date:0910053533 17.08.2012 Defer Date:16.05.2013 99

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

18 04 2013 Status:Case Deferred

18.04.2013 Deferred HQ File :01/82/050/00666/AM13/ RLA File :08/24/040/00147/AM13/ Lic.No/Date:0810114381 21.08.2012 Defer Date:16.05.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/663/2012PI(Norms) dated 12.3.2013, it was decided to call from the firm the following details:  Complete description and quantitative requirement applied for import for the manufacture of 1 kg Omeprazole API.  There are 3 export products. The norms applied for import against each export product may be given separately. 100

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

Party Name:ASCENT FINECHEM PVT. LTD., 18.04.2013 Status:Case Approved HQ File :01/82/050/00699/AM13/ RLA File :08/24/040/00160/AM13/ Lic.No/Date:0810114398 21.08.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/1/2012Ch. II dated 1.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed Raspberry Ketone/4(4 Hydroxyphenyl)Butane2 one white crystalline Powder Packed in G2 Pac Assembly 700 Liter/250 Kgs 35 inchx35 inch polyprpelene woven fabric bags 110 Nos. 1 kg 1. pHydroxy Benzaldehyde Light Yellow Crystalline Powder 1.69 kg 2. Acetone Colourless liquid 0.802 kg 3. G2 Pac Assembly 700 Liter/250 kgs 35 inch x 35 inch polypropylene woven fabric bags 700 liter/250 Kgs 35 inch x 35 inch x 35 inch polypropylene woven fabric bags Relevant, as per packing policy 101

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

Party Name:BAL PHARMA LTD 18.04.2013 Status:Case Approved HQ File :01/82/050/00682/AM13/ RLA File :07/24/040/00221/AM13/ Lic.No/Date:0710090348 23.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/680/2012PI(Norms) dated 1.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed

Amiloridel HCL 1 kg 1. Methyl3,5Diamino6 Chloro Pyrazine2 Carboxylate 0.836 kg 2. Guanidine HCL 0.40 kg 102

Case No.:5/22/82ALC4/2012

Party Name:SANOFI INDIA LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/00708/AM13/ RLA File :03/95/040/00318/AM13/ Lic.No/Date:0310706473 27.08.2012 Defer Date:16.05.2013 103

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

Party Name:UNITED BIOTECH PVT.LTD. 18.04.2013 Status:Case Approved HQ File :01/82/050/00636/AM13/ RLA File :05/24/040/00202/AM13/ Lic.No/Date:0510332772 28.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/29/2013PI(Norms) dated 1.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed Oxaliplatin Injection 50 MG/25 ML (Oplatin 50) 5000 Nos. 1. Oxaliplatin Raw Pharmaceutical Ingredient 262.50 gms Oxaliplatin Injection 100 MG/50 ML 4500 Nos. 1. Oxaliplatin Raw Pharmaceutical Ingredient 472.50 gms Noradrenaline Acid Tartrate Injection BP 4 MG (Noralin) Amploules 213750 Nos 1. Noradrenaline B1 Tartarate Raw Pharmaceutical Ingredient The composition of the Export product does not match with DML furnished. 104

Case No.:35/24/82ALC4/2012

Party Name:DR REDDYS LABORATORIES LIMITED 18.04.2013 Status:Case Approved HQ File :01/82/050/00839/AM13/ RLA File :09/24/040/00245/AM13/ Lic.No/Date:0910053622 29.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/111/2013PI(Norms) dated 25.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed

Q y Valsartan 1 kg 1. N(2Cyanobiphenyl4 Methyl)(L) Valine Methyl Ester HCL 1.40 kg 2. Activated Carbon 0.100 kg 3. Methylene Chloride 8.22 kg 4. nHeptane 9.75 kg 105

Case No.:40/22/82ALC4/2012

Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/00743/AM13/ RLA File :03/94/040/00109/AM13/ Lic.No/Date:0310707803 05.09.2012 Defer Date:16.05.2013 Decision : Department of Pharmaceuticals vide their OM No. 35011/686/2012PI(Norms) dated 12.3.2013, has informed that the firm has applied for the import of 2cyano4methyl biphenyl (OTBN) whereas the chemistry and other details shows the starting stage of 2cyano4bromomethyl biphenyl. It was decided to call from the firm to furnish actual import and the relevant chemistry. 106

Case No.:62/22/82ALC4/2012

18.04.2013 Status:Case Approved HQ File :01/82/050/00765/AM13/ RLA File :03/94/040/00429/AM13/ Lic.No/Date:0310707808 05.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/706/2012PI(Norms) dated 25.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed 4chloro2,6Di (Pyrrolidin1 yl)Pyrimidine 1 kg 1. 2,4,6Trichloro Pyrimidine 0.773 kg 107

Case No.:78/22/82ALC4/2012

18.04.2013 Status:Case Approved HQ File :01/82/050/00781/AM13/ RLA File :03/94/040/00430/AM13/ Lic.No/Date:0310707806 05.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/706/2012PI(Norms) dated 25.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed 4chloro2,6Di 1 kg 1. 2,4,6Trichloro Pyrimidine 0.773 kg

(Pyrrolidin1 yl)Pyrimidine 108

Case No.:39/26/82ALC4/2012

Party Name:AUCTUS PHARMA LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/00947/AM13/ RLA File :09/24/040/00276/AM13/ Lic.No/Date:0910053682 06.09.2012 Defer Date:16.05.2013 109

Case No.:58/22/82ALC4/2012

18.04.2013 Status:Case Deferred HQ File :01/82/050/00761/AM13/ RLA File :03/94/040/00113/AM13/ Lic.No/Date:0310707983 06.09.2012 Defer Date:16.05.2013 Decision : Department of Pharmaceuticals vide their OM No. 35011/686/2012PI(Norms) dated 12.3.2013, has informed that the firm has applied for the import of 2cyano4methyl biphenyl (OTBN) whereas the chemistry and other details shows the starting stage of 2cyano4bromomethyl biphenyl. It was decided to call from the firm to furnish actual import and the relevant chemistry. 110

Case No.:76/22/82ALC4/2012

18.04.2013 Status:Case Approved HQ File :01/82/050/00779/AM13/ RLA File :03/94/040/00437/AM13/ Lic.No/Date:0310708094 07.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/706/2012PI(Norms) dated 25.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed 4chloro2,6Di (Pyrrolidin1 yl)Pyrimidine 1 kg 1. 2,4,6Trichloro Pyrimidine 0.773 kg 111

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

Party Name:ZEE LABORATORIES 18.04.2013 Status:Case Deferred HQ File :01/82/050/00632/AM13/ RLA File :05/24/040/00220/AM13/ Lic.No/Date:0510334505 12.09.2012 Defer Date:16.05.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/37/2013PI(Norms) dated 1.4.2013, it was decided to call from the firm the following technical details:

 Copy of DML for 2 export products.  Copy of MBF duly authenticated by Quality Control Incharge  Reasons for variations in wastage claimed for the two export products. 112

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

18.04.2013 Status:Case Deferred HQ File :01/82/050/00633/AM13/ RLA File :08/24/040/00144/AM13/ Lic.No/Date:0810115056 12.09.2012 Defer Date:16.05.2013 113

Case No.:62/24/82ALC4/2012

Party Name:AMBUJA INTERMEDIATES LIMITED Meet No/Date:2/82ALC4/2013 18.04.2013 Status:Case Deferred HQ File :01/82/050/00866/AM13/ RLA File :03/94/040/00383/AM13/ Lic.No/Date:0310709139 14.09.2012 Defer Date:18.04.2013 Decision :It was decided to remind the firm to furnish the following information : Details of manufacturing process with chemical equations, molecular formula, molecular weight. Yield obtained in each step. Authentic technical literature in support of yield obtained. CA certificate certifying the production of export item achieved by the firm for the last three years and corresponding consumption of each input. The case was deferred for 16.05.2013. 114

Case No.:66/24/82ALC4/2012

Party Name:IPCA LABORATORIES LIMITED 18.04.2013 Status:Case Rejected HQ File :01/82/050/00870/AM13/ RLA File :03/94/040/00423/AM13/ Lic.No/Date:0310709103 14.09.2012 Defer Date: Decision :Withdrawn as the case was already approved in 33/82 meeting. 115

Case No.:77/24/82ALC4/2012

Party Name:ASHISH LIFE SCIENCE PVT.LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/00881/AM13/ RLA File :03/94/040/00378/AM13/ Lic.No/Date:0310709108 14.09.2012 Defer Date:16.05.2013 Decision :It was decided to give a final reminder to the firm to furnish the complete details of their export product and also a copy of valid Drug Manufacturing License, within 15 days else their case would be closed. The case was deferred for 16.05.2013.

Case No.:74/24/82ALC4/2012

Status:Case

116 y 18.04.2013 Approved HQ File :01/82/050/00878/AM13/ RLA File :03/94/040/00460/AM13/ Lic.No/Date:0310709540 18.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/168/2013PI(norms) dated 25.4.2013, 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 Product Quantity Allowed Lumefantrine 1 kg 1. 2(Dibutylamino)1(2,7 dichloro9HFluoren4yl) Ethanol 0.96 kg 2. pChlorobenzaldehyde 0.3478 kg 117

Case No.:87/24/82ALC4/2012

Party Name:METROPOLITAN EXIMCHEM LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/00891/AM13/ RLA File :03/95/040/00466/AM13/ Lic.No/Date:0310710207 24.09.2012 Defer Date:16.05.2013 Decision :It was decided to defer the case for 16.05.2013 for comments of Department of Chemicals and Petrochemicals 118

Case No.:85/24/82ALC4/2012

Party Name:MAKSON INDUSTRIES PVT. LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/00889/AM13/ RLA File :03/95/040/00394/AM13/ Lic.No/Date:0310710561 26.09.2012 Defer Date:16.05.2013 Decision :It was decided to remind the firm to furnish the following information sought by DC(MSME) vide their letter dated 12.2.2013: • Consumption data of imported and indigenous inputs used for the manufacture of export product quantitywise duly certified by excise department for the last three years. • Detailed justification of wastage claimed at each stage. • Copy of the formulation of export product duly approved by concerned authority under drug and cosmetic act. • Earlier authorization of the above product, if any. The case was deferred for 16.05.2013 119

Case No.:76/24/82ALC4/2012

Party Name:ENCUBE ETHICALS PVT LTD 18.04.2013 Status:Case Deferred HQ File :01/82/050/00880/AM13/ RLA File :03/94/040/00500/AM13/ Lic.No/Date:0310711014 28.09.2012 Defer Date:16.05.2013 Decision :A copy of reply received from the firm was sent to Department of Pharmaceuticals for their comments. The case was deferred for 16.05.2013

Case No.:96/24/82ALC4/2012

Party Name:TIDE INDUSTRIES 18.04.2013 Status:Case Deferred

120 HQ File :01/82/050/00900/AM13/ RLA File :34/24/040/00158/AM13/ Lic.No/Date:3410035264 01.10.2012 Defer Date:16.05.2013 Decision :It was decided to defer the case for 16.05.2013 for comments of Department of Chemicals and Petrochemicals 121

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

18.04.2013 Status:Case Approved HQ File :01/82/050/00919/AM13/ RLA File :03/94/040/00481/AM13/ Lic.No/Date:0310711379 03.10.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/129/2013PI(Norms) dated 25.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed Azithromycin Monohydrate 1 kg 1. Erythromycin Oxime 1.36 kg 122

Case No.:12/26/82ALC4/2012

18.04.2013 Status:Case Deferred HQ File :01/82/050/00920/AM13/ RLA File :03/94/040/00522/AM13/ Lic.No/Date:0310711393 03.10.2012 Defer Date:18.04.2013 Decision :It was decided to defer the case for 16.05.2013 for comments of Department of C&PC 123

Case No.:13/26/82ALC4/2012

18.04.2013 Status:Case Approved HQ File :01/82/050/00921/AM13/ RLA File :03/94/040/00482/AM13/ Lic.No/Date:0310711389 03.10.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/129/2013PI(Norms) dated 25.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed Azithromycin Monohydrate 1 kg 1. Erythromycin Oxime 1.36 kg

Case No.:10/26/82ALC4/2012

18.04.2013 Status:Case Approved HQ File :01/82/050/00918/AM13/ RLA File :03/94/040/00024/AM13/ Lic.No/Date:0310711638 04.10.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/153/2013PI(Norms) dated 25 4 2013 it d id d t tif d P 4 7 f HBP 1 d t il i b l li d b th fi hi h i l

124 25.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed NBenzyl2(1H Imidazol1 yl)Acetamide 1 kg 1. Ethyl2(1HImidazole1 yl) Acetate 0.909 kg 125

Case No.:3/22/82ALC4/2012

Party Name:ULTRATECH INDIA LTD. 18.04.2013 Status:Case Approved HQ File :01/82/050/00706/AM13/ RLA File :03/95/040/00310/AM13/ Lic.No/Date:0310711590 04.10.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/55/2013PI(Norms) dated 1.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed 2[((3Methyl4(2,2,2 Trifluoro Ethoxy)2 Pyridinyl)Methyl) Thio]—1H Benzimidazole 1 kg 1. 2,2,2Trifluoro Ethanol 0.65 kg 2. 2,3Lutidine 0.65 kg 126

Case No.:52/24/82ALC4/2012

Party Name:INDO PHYTO CHEMICALS PVT LTD 18.04.2013 Status:Case Approved HQ File :01/82/050/00856/AM13/ RLA File :05/23/040/00253/AM13/ Lic.No/Date:0510336431 04.10.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/74/2013PI(Norms) dated 25.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed Allylestrenol Bulk Drug 1 kg 1. Sitolactone Intermediate 1.95 kg 2. 5Chloro2pentanone Reagent 1.81 kg 3. Tetrahydrofuran Solvent 5.80 kg 4. Pyridine Reagent 0.87 kg RA may take appropriate action as per the decision of Norms Committee

127

Case No.:9/26/82ALC4/2012

18.04.2013 Status:Case Approved HQ File :01/82/050/00917/AM13/ RLA File :03/94/040/00099/AM13/ Lic.No/Date:0310711648 04.10.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/683/2012PI(Norms) dated 1.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed 2((1HImidazole1 YL)Methyl)1HBenzo [D] Imidazole 1 kg 1. 1carboxymethyl Imidazole 0.86 kg 128

Case No.:14/28/82ALC4/2012

Party Name:BILCARE LIMITED 18.04.2013 Status:Case Rejected HQ File :01/82/050/00981/AM13/ RLA File :31/83/040/00123/AM13/ Lic.No/Date:3110056018 09.10.2012 Defer Date: Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders and also did not attend the PH 129

Case No.:91/24/82ALC4/2012

Party Name:SMB MEDICAL DEVICES PVT. LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/00895/AM13/ RLA File :03/95/040/00446/AM13/ Lic.No/Date:0310712446 11.10.2012 Defer Date:16.05.2013 Decision : Department of Chemicals and Petrochemicals vide their letter no. 46011/20/2013PC II dated 4.4.2013 has requested the firm to furnish following information: Technical specifications, % composition 9by weight), weight per piece and the copy of export order for the export product i.e. Intrauterine Contraceptive Device Copper T 380 Ag may be furnished. Details and quantity of other indigenous inputs to be used in the manufacture of the export product may be indicated. Detailed manufacturing process along with justification for wastages at each stage and also on each of the raw material may be furnished. The net weight of item of import i.e. Copper Silver 10 Alloy Silver Content 10% Nominal) in one piece of export product and quantity applied (net content+wastages, if any) may be furnished with technical justification. Complete material balance indicating input and output material at each stage of manufacturing process. Details of production of export product under reference and corresponding consumption of raw material in the year 201112 and 201213 (April to December) 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. Any other relevant information. The case was deferred for 16.5.2013

130

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

Party Name:ADESHWAR MEDITEX PVT. LTD 18.04.2013 Status:Case Deferred HQ File :01/82/050/01061/AM13/ RLA File :03/94/040/00597/AM13/ Lic.No/Date:0310712671 12.10.2012 Defer Date:16.05.2013 Decision :In the light of written comments received from Department of industrial Policy and Promotion, vide their U.O No. 7/92/2013TSW/41 dated 25.3.2013, it was decided to call from the firm the following information:  Complete manufacturing process involved in the item of export indicating the wastage generated at each stage of manufacture, duly certified by a Chartered Engineer.  Description of import and export item are the same and both are of standard size. Therefore, complete justification may be provided for exporting the item and the actual activity involved.  Commercial value of the wastage generated during the manufacturing process.  Production of the item of export cisavis consumption of raw materials (both imported and indigenous) during the past three years, separately for each export item, duly certified by Chartered Accountant. 131

Case No.:9/24/82ALC4/2012

Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/00813/AM13/ RLA File :02/24/040/00119/AM13/ Lic.No/Date:0210183299 17.10.2012 Defer Date:16.05.2013 132

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

Party Name:TITAN LABORATORIES PVT. LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/00803/AM13/ RLA File :03/95/040/00544/AM13/ Lic.No/Date:0310713360 22.10.2012 Defer Date:16.05.2013 Decision :It was decided to defer the case for 16.05.2013 for comments of Department of Chemicals and Petrochemicals 133

Case No.:42/31/82ALC4/2012

Party Name:AARTI INDUSTRIES LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01082/AM13/ RLA File :03/94/040/00574/AM13/ Lic.No/Date:0310713516 23.10.2012 Defer Date:16.05.2013 134

Case No.:51/28/82ALC4/2012

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01018/AM13/ RLA File :03/95/040/00495/AM13/ Lic.No/Date:0310713489 23 10 2012 Defer D t 16 05 2013

134 23.10.2012 Date:16.05.2013 Decision :It was decided to remind the firm to furnish the technical details as per Appendix 33 without any further delay otherwise their case would be closed. The case was deferred for 16.05.2013. 135

Case No.:36/31/82ALC4/2012

18.04.2013 Status:Case Deferred HQ File :01/82/050/01076/AM13/ RLA File :03/94/040/00642/AM13/ Lic.No/Date:0310713679 29.10.2012 Defer Date:16.05.2013 136

Case No.:9/28/82ALC4/2012

Party Name:MEDCHL CHEMICALS AND PHARMACEUTICALS PVT LTD 18.04.2013 Status:Deffered HQ File :01/82/050/00976/AM13/ RLA File :09/24/040/00374/AM13/ Lic.No/Date:0910054204 30.10.2012 Defer Date:16.5.2013 137

Case No.:105/33/82ALC4/2012

Party Name:AUROBINDO PHARMA LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01252/AM13/ RLA File :09/24/040/00361/AM13/ Lic.No/Date:0910054229 01.11.2012 Defer Date:16.05.2013 138

Case No.:37/31/82ALC4/2012

18.04.2013 Status:Case Deferred HQ File :01/82/050/01077/AM13/ RLA File :03/94/040/00641/AM13/ Lic.No/Date:0310714114 01.11.2012 Defer Date:16.05.2013 139

Case No.:50/31/82ALC4/2012

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 18.04.2013 Status:Case Deferred HQ File :01/82/050/01090/AM13/ RLA File :03/94/040/00495/AM13/ Lic.No/Date:0310714105 01.11.2012 Defer Date:16.05.2013 Decision :In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/29/20111/Ch II dated 4.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed 3Chloro Benzyl Chloride or Meta Chloro Benzyl Chloride 1 kg 1. Meta Chloro Toluene 0.982 kg 2. Azo Bis Isobutyro Nitrile 0.011 kg

140

Case No.:95/24/82ALC4/2012

Party Name:SOLARIS CHEMTECH INDUSTRIES LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/00899/AM13/ RLA File :34/24/040/00188/AM13/ Lic.No/Date:3410035412 01.11.2012 Defer Date:16.05.2013 141

Case No.:7/31/82ALC4/2012

Party Name:RANBAXY LABORATORIES LTD 18.04.2013 Status:Case Deferred HQ File :01/82/050/01047/AM13/ RLA File :05/24/040/00277/AM13/ Lic.No/Date:0510338116 02.11.2012 Defer Date:16.05.2013 142

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

18.04.2013 Status:Case Approved HQ File :01/82/050/00930/AM13/ RLA File :03/95/040/00370/AM13/ Lic.No/Date:0310714238 05.11.2012 Defer Date: Decision :Withdrawn as the case was approved in 1/82 meeting dated 4.4.2013 143

Case No.:89/33/82ALC4/2012

Party Name:RA CHEM PHARMA LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01236/AM13/ RLA File :09/24/040/00376/AM13/ Lic.No/Date:0910054253 05.11.2012 Defer Date:16.05.2013 144

Case No.:95/33/82ALC4/2012

Party Name:MYLAN LABORATORIES LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01242/AM13/ RLA File :09/24/040/00342/AM13/ Lic.No/Date:0910054286 08.11.2012 Defer Date:16.05.2013

Case No.:1/25/82ALC4/2012

Party Name:SWISS PARENTERALS PVT.LTD. 18.04.2013 Status:Case Approved HQ File :01/82/050/00905/AM13/ RLA File :08/24/040/00271/AM13/ Lic.No/Date:0810116219 09.11.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/647/2012PI(Norms) dated 12.3.2013, 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: E t P d t E t S N I t P d t Q tit All d

145 Export Product Export Quantity S.No Import Product Quantity Allowed 40 mg 500 mg Methyl Prednisolone Sodium Succinate for Inj. USP 40 mg & 500 mg 1 no. of vial 1. Methyl Prednisolone Sodium Succinate USP 55.688 mg 696.0 mg 146

Case No.:15/33/82ALC4/2012

Party Name:INDSWIFT LABORATORIES LTD., 18.04.2013 Status:Case Deferred HQ File :01/82/050/01162/AM13/ RLA File :22/24/040/00039/AM13/ Lic.No/Date:2210013390 09.11.2012 Defer Date:16.05.2013 Decision ::It was decided to defer the case for 16.05.2013 for comments of Department of Pharmaceuticals 147

Case No.:170/33/82ALC4/2012

Party Name:RANTUS PHARMA PVT LTD 18.04.2013 Status:Case Deferred HQ File :01/82/050/01317/AM13/ RLA File :09/24/040/00367/AM13/ Lic.No/Date:0910054294 09.11.2012 Defer Date:16.05.2013 Decision ::It was decided to defer the case for 16.05.2013 for comments of Department of Pharmaceuticals 148

Case No.:23/31/82ALC4/2012

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01063/AM13/ RLA File :03/95/040/00555/AM13/ Lic.No/Date:0310714767 09.11.2012 Defer Date:16.05.2013 Decision :it was decided to remind the firm to furnish technical details as per Appendix 33. The case was deferred for 16.05.2013 149

Case No.:25/31/82ALC4/2012

Party Name:THINQ PHARMACRO LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01065/AM13/ RLA File :03/95/040/00602/AM13/ Lic.No/Date:0310714790 09.11.2012 Defer Date:16.05.2013 Decision ::It was decided to defer the case for 16.05.2013 for comments of Department of Pharmaceuticals. 150

Case No.:8/31/82ALC4/2012

Party Name:ADVANCE PETROCHEMICALS LIMITED 18.04.2013 Status:Case Approved HQ File :01/82/050/01048/AM13/ RLA File :08/24/040/00283/AM13/ Lic.No/Date:0810116295 12.11.2012 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 26.3.2013, 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 Export S No Import Product Quantity Allowed

Export Product Export Quantity S.No Import Product Quantity Allowed 2Methoxy Ethanol 1 kg 1 Methanol 0.589 kg 2. Ethylene Oxide 0.443 kg 151

Case No.:148/33/82ALC4/2012

Party Name:MYLAN LABORATORIES LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01295/AM13/ RLA File :09/24/040/00359/AM13/ Lic.No/Date:0910054335 15.11.2012 Defer Date:16.05.2013 Decision ::It was decided to defer the case for 16.05.2013 for comments of Department of Pharmaceuticals 152

Case No.:39/31/82ALC4/2012

Party Name:CIPLA LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01079/AM13/ RLA File :03/94/040/00696/AM13/ Lic.No/Date:0310715048 16.11.2012 Defer Date: 16.5.2013 153

Case No.:90/33/82ALC4/2012

Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 18.04.2013 Status:Case Deferred HQ File :01/82/050/01237/AM13/ RLA File :09/24/040/00394/AM13/ Lic.No/Date:0910054339 19.11.2012 Defer Date:16.05.2013 Decision ::It was decided to defer the case for 16.05.2013 for comments of Department of Pharmaceuticals 154

Case No.:16/33/82ALC4/2012

Party Name:PROMED EXPORTS PVT.LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/01163/AM13/ RLA File :05/24/040/00308/AM13/ Lic.No/Date:0510339206 20.11.2012 Defer Date:16.05.2013 Decision ::It was decided to defer the case for 16.05.2013 for comments of Department of Pharmaceuticals 155

Case No.:179/33/82ALC4/2012

Party Name:SRINI PHARMACEUTICALS LTD., 18.04.2013 Status:Case Deferred HQ File :01/82/050/01326/AM13/ RLA File :09/24/040/00393/AM13/ Lic.No/Date:0910054348 20.11.2012 Defer Date:16.05.2013 Decision ::It was decided to defer the case for 16.05.2013 for comments of Department of Pharmaceuticals 156

Case No.:181/33/82ALC4/2012

Party Name:RA CHEM PHARMA LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01328/AM13/ RLA File :09/24/040/00401/AM13/ Lic.No/Date:0910054361 22 11 2012 Defer Date:16 05 2013

22.11.2012 Date:16.05.2013 Decision ::It was decided to defer the case for 16.05.2013 for comments of Department of Pharmaceuticals 157

Case No.:190/33/82ALC4/2012

Party Name:SRINI PHARMACEUTICALS LTD., 18.04.2013 Status:Case Approved HQ File :01/82/050/01337/AM13/ RLA File :09/24/040/00406/AM13/ Lic.No/Date:0910054373 23.11.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/84/2013PI(Norms) dated 1.4.2013, 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 Product Quantity Allowed Pregablin 1 kg 1. R()3(Carbamoyl Methyl5Methyl Hexanoic Acid 1.47 kg 158

Case No.:22/31/82ALC4/2012

18.04.2013 Status:Approved HQ File :01/82/050/01062/AM13/ RLA File :03/95/040/00643/AM13/ Lic.No/Date:0310715596 23.11.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011Ch. II dated 2.4.2013, 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 Copper Dibutyl Dithiocarbamate (CDBC) 1 kg 1. DINButylamine (Dibutylamine) 0.600 kg 2. Copper Sulphate 0.476 kg RA may take appropriate action as per the decision of Norms Committee 159

Case No.:48/31/82ALC4/2012

Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01088/AM13/ RLA File :03/94/040/00711/AM13/ Lic.No/Date:0310715606 23.11.2012 Defer Date:16.05.2013 Decision :it was decided to remind the firm to furnish technical details as per Appendix 33 mainly molecular weight of imported inputs and % yield on molar basis alongwith copy of relevant technical literature. The case was deferred for 16.05.2013.

Case No.:13/33/82ALC4/2012

Party Name:DEEPAK NITRITE LIMITED 18.04.2013 Status:Case Approved HQ File :01/82/050/01160/AM13/ RLA File :34/24/040/00181/AM13/ Lic.No/Date:3410035545 26.11.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/36/2012Ch. II dated 24 3 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:

160 dated 24.3.2013, 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 Export Quantity S.No Import Product Quantity Allowed 3Trifluoromethyl Aceto Phenone 1 kg 1 3 Amino Benzo Trifluoride 99.5% Min. 1.606 kg 2. Acetaldoxime 50% min. solution in water 1.178 kg 3. Sodium Nitrite 0.708 kg 4. Toluene 0.730 kg 5. Caustic Soda Lye 47% 1.028 kg 6. Copper Sulphate 0.155 kg 7. Acetic Acid 0.200 kg 8. Sulphamic Acid 0.020 kg 9. Soda Ash 0.069 kg 10 Sulphuric Acid 71% Not feasible to import. Therefore, no norms fixed 11. Hydrochloric Acid 30% 181

Case No.:191/33/82ALC4/2012

Party Name:VANI PHARMA LABS LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/01338/AM13/ RLA File :09/24/040/00357/AM13/ Lic.No/Date:0910054379 26.11.2012 Defer Date:16.05.2013 162

Case No.:120/33/82ALC4/2012

Party Name:AUROBINDO PHARMA LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01267/AM13/ RLA File :09/24/040/00396/AM13/ Lic.No/Date:0910054387 27.11.2012 Defer Date:16.05.2013 163

Case No.:166/33/82ALC4/2012

Party Name:PERKIN LABORATORIES 18.04.2013 Status:Case Deferred HQ File :01/82/050/01313/AM13/ RLA File :09/24/040/00382/AM13/ Lic.No/Date:0910054386 27.11.2012 Defer Date:16.05.2013

Case No.:167/33/82ALC4/2012

Party Name:AUROBINDO PHARMA LIMITED 18 04 2013 Status:Case f

164 18.04.2013 Deferred HQ File :01/82/050/01314/AM13/ RLA File :09/24/040/00391/AM13/ Lic.No/Date:0910054388 27.11.2012 Defer Date:16.05.2013 165

Case No.:73/31/82ALC4/2012

Party Name:ALKYL AMINES CHEMICALS LTD 18.04.2013 Status:Case Approved HQ File :01/82/050/01113/AM13/ RLA File :03/94/040/00689/AM13/ Lic.No/Date:0310715835 27.11.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/85/2012Ch. II dated 2.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed Acetonitrile 1 kg 1 Acetic Acid 1.460 kg 166

Case No.:72/31/82ALC4/2012

Party Name:ALKYL AMINES CHEMICALS LTD 18.04.2013 Status:Case Approved HQ File :01/82/050/01112/AM13/ RLA File :03/94/040/00398/AM13/ Lic.No/Date:0310715907 29.11.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/85/2012Ch. II dated 2.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed Acetonitrile 1 kg 1 Acetic Acid 1.460 kg 167

Case No.:9/31/82ALC4/2012

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01049/AM13/ RLA File :04/24/040/00182/AM13/ Lic.No/Date:0410141372 29.11.2012 Defer Date:16.05.2013 168

Case No.:108/33/82ALC4/2012

Party Name:VIVIMED LABS LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01255/AM13/ RLA File :09/24/040/00424/AM13/ Lic.No/Date:0910054414 30.11.2012 Defer Date:16.05.2013 Decision :It was decided to defer the case for 16.05.2013 for comments of Department of C7PC

169

Case No.:109/33/82ALC4/2012

Party Name:AUCTUS PHARMA LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01256/AM13/ RLA File :09/24/040/00409/AM13/ Lic.No/Date:0910054415 30.11.2012 Defer Date: 16.5.2013 170

Case No.:51/31/82ALC4/2012

Party Name:STERLING AUXILIARIES PVT LTD 18.04.2013 Status:Case Approved HQ File :01/82/050/01091/AM13/ RLA File :03/95/040/00632/AM13/ Lic.No/Date:0310716072 30.11.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their U.O No. 14010/74/2011Ch. II dated 23.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed STERO DMEA (Di Methyl Ethanol Amine) 1 kg 1. Di methyl amine (40%) 1.289 kg 2. Ethylene Oxide 0.504 kg STERO DMEA (Di Methyl Ethanol Amine) 1 kg 1. Luryl Alcohol 0.495 kg 2. Ethylene Oxide 0.505 kg STEROL 1312 (Iso Tri Decanol 9 mole Ethoxylated) 1 kg 1 ISO TRI Decanol (ITDA) 0.335 kg 2. Ethylene Oxide 0.664 kg STEROL 1850 (F) (Polyoxyethylene Stearyl ether/Stearyl) 1 kg 1. Stearyl Alcohol 0.135 kg 2. Ethylene Oxide 0.884 kg 171

Case No.:1/27/82ALC4/2012

Party Name:PORUS LABORATORIES PVT LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/00956/AM13/ RLA File :09/24/040/00426/AM13/ Lic.No/Date:0910054427 03.12.2012 Defer Date:16.05.2013 172

Case No.:123/33/82ALC4/2012

Party Name:MYLAN LABORATORIES LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01270/AM13/ RLA File :09/24/040/00405/AM13/ Lic.No/Date:0910054430 03.12.2012 Defer Date:16.05.2013

173

Case No.:128/33/82ALC4/2012

18.04.2013 Status:Case Deferred HQ File :01/82/050/01275/AM13/ RLA File :08/24/040/00304/AM13/ Lic.No/Date:0810116598 03.12.2012 Defer Date:16.05.2013 174

Case No.:112/33/82ALC4/2012

Party Name:STERICAT GUTSTRINGS PVT. LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/01259/AM13/ RLA File :05/24/040/00304/AM13/ Lic.No/Date:0510340033 04.12.2012 Defer Date:16.05.2013 Decision :In the light of written comments received from Department of Industrial Policy and Promotion vide their U.O No. 7/106/2013TSW/45 dated 3.4.2013, it was decided to call from the firm the following technical details:  An undertaking clearly indicting the import content of each input in the export product along with its specification like weight, width, thickness of import item No. 1, 7,13,19 and 24.  A detailed calculation sheet may be furnished accounting for the total individual item of proposed import as also to the net content of individual item in the 5 individual consignment of the proposed item of export in 540, 28735, 25, 1260 and 1440 boxes respectively. 175

Case No.:14/33/82ALC4/2012

Party Name:RANBAXY LABORATORIES LTD 18.04.2013 Status:Case Deferred HQ File :01/82/050/01161/AM13/ RLA File :05/24/040/00324/AM13/ Lic.No/Date:0510340056 04.12.2012 Defer Date:16.05.2013 176

Case No.:18/33/82ALC4/2012

Party Name:RANBAXY LABORATORIES LTD 18.04.2013 Status:Case Deferred HQ File :01/82/050/01165/AM13/ RLA File :05/24/040/00325/AM13/ Lic.No/Date:0510340057 04.12.2012 Defer Date:16.05.2013 177

Case No.:2/27/82ALC4/2012

Party Name:GOPINATH CHEMTECH LTD., 18.04.2013 Status:Case Deferred HQ File :01/82/050/00957/AM13/ RLA File :08/24/040/00295/AM13/ Lic.No/Date:0810116627 04.12.2012 Defer Date: 16.5.2013 Decision : It was decided to defer the case for 16.5.2013 for comments of Department of Chemicals and Petrochemicals.

Case No :24/31/82 ALC4/2012

Part Name:METROPOLITAN EXIMCHEM LTD Meet No/Date:2/82 ALC4/2013 Status:Case

178

Case No.:24/31/82ALC4/2012

Party Name:METROPOLITAN EXIMCHEM LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/01064/AM13/ RLA File :03/95/040/00661/AM13/ Lic.No/Date:0310716278 04.12.2012 Defer Date:16.05.2013 179

Case No.:29/31/82ALC4/2012

18.04.2013 Status:Case Approved HQ File :01/82/050/01069/AM13/ RLA File :03/95/040/00677/AM13/ Lic.No/Date:0310716279 04.12.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011Ch. II dated 2.4.2013, 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 Methyl Eugenol 1 kg 1 Clove Leaf Oil (Eugenol Content 78%) 1.40 kg 180

Case No.:185/33/82ALC4/2012

Party Name:S.M. HERBALS PVT.LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/01332/AM13/ RLA File :05/24/040/00331/AM13/ Lic.No/Date:0510340123 05.12.2012 Defer Date:16.05.2013 181

Case No.:187/33/82ALC4/2012

Party Name:MICRO LABS LTD 18.04.2013 Status:Case Deferred HQ File :01/82/050/01334/AM13/ RLA File :07/24/040/00344/AM13/ Lic.No/Date:0710092287 05.12.2012 Defer Date:16.05.2013 182

Case No.:73/33/82ALC4/2012

Party Name:SRINI PHARMACEUTICALS LTD., 18.04.2013 Status:Case Deferred HQ File :01/82/050/01220/AM13/ RLA File :09/24/040/00429/AM13/ Lic.No/Date:0910054448 05.12.2012 Defer Date:16.05.2013 183

Case No.:30/31/82ALC4/2012

Party Name:S.KANT HEALTHCARE LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/01070/AM13/ RLA File :03/95/040/00670/AM13/ Lic.No/Date:0310716370 05.12.2012 Defer Date:16.05.2013

05.12.2012 Date:16.05.2013 184

Case No.:57/31/82ALC4/2012

Party Name:ACTGEN PHARMA PVT. LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/01097/AM13/ RLA File :03/94/040/00728/AM13/ Lic.No/Date:0310716371 05.12.2012 Defer Date:16.05.2013 185

Case No.:93/33/82ALC4/2012

Party Name:DR REDDYS LABORATORIES LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01240/AM13/ RLA File :09/24/040/00237/AM13/ Lic.No/Date:0910054437 05.12.2012 Defer Date:16.05.2013 Decision :It was decided to defer the case for 16.5.2013 for comments of Department of Pharmaceuticals. 186

Case No.:127/33/82ALC4/2012

18.04.2013 Status:Case Deferred HQ File :01/82/050/01274/AM13/ RLA File :08/24/040/00155/AM13/ Lic.No/Date:0810116730 07.12.2012 Defer Date:16.05.2013 187

Case No.:168/33/82ALC4/2012

18.04.2013 Status:Case Deferred HQ File :01/82/050/01315/AM13/ RLA File :08/24/040/00253/AM13/ Lic.No/Date:0810116731 07.12.2012 Defer Date:16.05.2013 188

Case No.:172/33/82ALC4/2012

Party Name:CADILA PHARMACEUTICALS LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/01319/AM13/ RLA File :08/24/040/00303/AM13/ Lic.No/Date:0810116727 07.12.2012 Defer Date:16.05.2013 189

Case No.:176/33/82ALC4/2012

18.04.2013 Status:Case Deferred HQ File :01/82/050/01323/AM13/ RLA File :08/24/040/00301/AM13/ Lic.No/Date:0810116729 07.12.2012 Defer Date:16.05.2013

190

Case No.:188/33/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01335/AM13/ RLA File :05/23/040/00345/AM13/ Lic.No/Date:0510340432 07.12.2012 Defer Date:16.05.2013 191

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

Party Name:PORUS LABORATORIES PVT LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/00959/AM13/ RLA File :09/24/040/00408/AM13/ Lic.No/Date:0910054464 07.12.2012 Defer Date:16.05.2013 Decision :It was decided to defer the case for 16.05.2013 for comments of Department of C&PC. 192

Case No.:41/33/82ALC4/2012

Party Name:GITANJALI CHEMICALS PVT LTD 18.04.2013 Status:Case Deferred HQ File :01/82/050/01188/AM13/ RLA File :03/94/040/00747/AM13/ Lic.No/Date:0310716657 07.12.2012 Defer Date:16.05.2013 193

Case No.:43/33/82ALC4/2012

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 18.04.2013 Status:Case Deferred HQ File :01/82/050/01190/AM13/ RLA File :03/94/040/00727/AM13/ Lic.No/Date:0310716674 07.12.2012 Defer Date:16.05.2013 194

Case No.:175/33/82ALC4/2012

Party Name:DHANUKA LABORATORIES LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/01322/AM13/ RLA File :05/23/040/00356/AM13/ Lic.No/Date:0510340518 10.12.2012 Defer Date:16.05.2013 195

Case No.:76/33/82ALC4/2012

Party Name:MYLAN LABORATORIES LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01223/AM13/ RLA File :09/24/040/00411/AM13/ Lic.No/Date:0910054467 10.12.2012 Defer Date:16.05.2013 196

Case No.:177/33/82ALC4/2012

18 04 2013 Status:Case Approved

18.04.2013 Approved HQ File :01/82/050/01324/AM13/ RLA File :08/24/040/00251/AM13/ Lic.No/Date:0810116810 11.12.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 18/82 dated 30.8.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Metformin HCL 500 mg tabs. 1000 tablets 1. Metformin HCL USP. 0.5100 kg 2. Microcrystalline Cellulose, NF (Avicel PH 101) 0.0225 kg 3. Povidone K 30 0.0200 kg 4. Microcrystalline Cellulose (Avicel PH 102) 0.0200 kg 5. Magnesium Stearate 0.0015 kg 6. Hypermellose 6 CPS 2910 0.0045 kg 716. Bottles & Caps (packing material in finished form) As per packing policy. Metformin HCL 850 mg Tabs 1000 Tablets 1. Meformin HCL USP 0.8670 kg 2. Microcrystalline cellulose, NF (Avicel PH 101) 0.03825 kg 3. Povidone K 30 0.0340 kg 4. Micrystalline cellulose (Avicel PH 102) 0.0340 kg 5. Magnesium Stearate 0.00255 kg 6. Hypermellose 6 CPS 2910 0.00765 kg 716. Bottles & Caps (packing material in finished form) As per packing policy Metformin HCL 1000 mg tablets 1000 tablets 1 Meformin HCL USP 1.0200 kg 2 Microcrystalline cellulose, NF (Avicel PH 101) 0.0450 kg 3 Povidone K 30 0.0400 kg 4 Micrystalline cellulose (Avicel PH 102) 0.0400 kg 5 Magnesium Stearate 0.0030 kg 6 Hypermellose 6 CPS 2910 0.0090 kg 716 Bottles & Caps (packing material in finished form) As per packing policy RA may take appropriate action as per the packing policy. 197

Case No.:10/27/82ALC4/2012

Party Name:AUROBINDO PHARMA LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/00965/AM13/ RLA File :09/24/040/00416/AM13/ Lic.No/Date:0910054496 12.12.2012 Defer Date:16.5.2013

Case No.:13/31/82ALC4/2012

Party Name:SHIVA PHARMACHEM LTD, 18.04.2013 Status:Case Deferred

198 HQ File :01/82/050/01053/AM13/ RLA File :34/24/040/00218/AM13/ Lic.No/Date:3410035633 12.12.2012 Defer Date:16.05.2013 199

Case No.:66/33/82ALC4/2012

Party Name:AUCTUS PHARMA LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01213/AM13/ RLA File :09/24/040/00443/AM13/ Lic.No/Date:0910054499 12.12.2012 Defer Date:16.05.2013 200

Case No.:126/33/82ALC4/2012

18.04.2013 Status:Case Deferred HQ File :01/82/050/01273/AM13/ RLA File :08/24/040/00315/AM13/ Lic.No/Date:0810116862 13.12.2012 Defer Date:16.05.2013 Decision :It was decided to remind the firm to furnish full description of export items. The case was deferred for 16.05.2013. 201

Case No.:77/33/82ALC4/2012

Party Name:GRANULES INDIA LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01224/AM13/ RLA File :09/24/040/00404/AM13/ Lic.No/Date:0910054501 13.12.2012 Defer Date:16.05.2013 202

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

18.04.2013 Status:Case Approved HQ File :01/82/050/01122/AM13/ RLA File :03/95/040/00691/AM13/ Lic.No/Date:0310717131 13.12.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011Ch. II dated 2.4.2013, 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 Methyl Eugenol 1 kg 1 Clove Leaf Oil (Eugenol Content 78%) 1.40 kg 203

Case No.:10/33/82ALC4/2012

Party Name:NEOGEN CHEMICALS LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01157/AM13/ RLA File :03/95/040/00569/AM13/ Lic.No/Date:0310717225 14.12.2012 Defer Date:16.05.2013

204

Case No.:140/33/82ALC4/2012

Party Name:HETERO DRUGS LIMITED, 18.04.2013 Status:Case Deferred HQ File :01/82/050/01287/AM13/ RLA File :09/24/040/00448/AM13/ Lic.No/Date:0910054511 14.12.2012 Defer Date:16.05.2013 205

Case No.:64/31/82ALC4/2012

Party Name:CONCEPT PHARMACEUTICALS LTD., 18.04.2013 Status:Case Deferred HQ File :01/82/050/01104/AM13/ RLA File :03/94/040/00700/AM13/ Lic.No/Date:0310717229 14.12.2012 Defer Date:16.05.2013 206

Case No.:84/31/82ALC4/2012

18.04.2013 Status:Case Approved HQ File :01/82/050/01124/AM13/ RLA File :03/95/040/00696/AM13/ Lic.No/Date:0310717237 14.12.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their U.O No. 14010/95/2011Ch. II dated 2.4.2013, 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 Yantq 3030 B (30% solution of Tertiary Butyl Hydroquinone) 1 kg 1 Hydroquinone 0.423 kg 2. Tertiary Butanol 0.312 kg 3. Propylene Glycol 0.700 kg 207

Case No.:85/31/82ALC4/2012

Party Name:SANOFI INDIA LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01125/AM13/ RLA File :03/95/040/00465/AM13/ Lic.No/Date:0310717240 14.12.2012 Defer Date:16.05.2013 208

Case No.:11/27/82ALC4/2012

Party Name:INDSWIFT LABORATORIES LTD., 18.04.2013 Status:Case Deferred HQ File :01/82/050/00966/AM13/ RLA File :22/24/040/00051/AM13/ Lic.No/Date:2210013450 17.12.2012 Defer Date:16.05.2013 209

Case No.:83/31/82ALC4/2012

18.04.2013 Status:Case Deferred HQ File :01/82/050/01123/AM13/ RLA File :03/95/040/00709/AM13/ Lic No/Date:0310717365 Defer

209 HQ File :01/82/050/01123/AM13/ RLA File :03/95/040/00709/AM13/ Lic.No/Date:0310717365 17.12.2012 Defer Date:16.05.2013 210

Case No.:9/33/82ALC4/2012

Party Name:NEOGEN CHEMICALS LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01156/AM13/ RLA File :03/95/040/00683/AM13/ Lic.No/Date:0310717358 17.12.2012 Defer Date:16.05.2013 211

Case No.:104/33/82ALC4/2012

Party Name:FRESENIUS KABI ONCOLOGY LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01251/AM13/ RLA File :05/23/040/00239/AM13/ Lic.No/Date:0510341177 18.12.2012 Defer Date:16.05.2013 212

Case No.:110/33/82ALC4/2012

Party Name:INTAS PHARMACEUTICALS LTD., 18.04.2013 Status:Case Deferred HQ File :01/82/050/01257/AM13/ RLA File :08/24/040/00324/AM13/ Lic.No/Date:0810116928 18.12.2012 Defer Date:16.05.2013 213

Case No.:116/33/82ALC4/2012

Party Name:BAL PHARMA LTD 18.04.2013 Status:Case Approved HQ File :01/82/050/01263/AM13/ RLA File :07/24/040/00376/AM13/ Lic.No/Date:0710092545 18.12.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/680/2012PI(Norms) dated 1.4.2013, 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 Amiloride HCL 1 kg 1. Methyl 3,5Diamino 6Chloro Pyrazine2Carboxylate 0.836 kg 2. Guanidine HCL 0.40 kg 214

Case No.:125/33/82ALC4/2012

Party Name:SYMBIOTEC PHARMALAB LTD., 18.04.2013 Status:Case Deferred HQ File :01/82/050/01272/AM13/ RLA File :56/24/040/00032/AM13/ Lic.No/Date:5610001382 18.12.2012 Defer Date:16.05.2013

215

Case No.:131/33/82ALC4/2012

Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 18.04.2013 Status:Case Deferred HQ File :01/82/050/01278/AM13/ RLA File :07/24/040/00377/AM13/ Lic.No/Date:0710092564 18.12.2012 Defer Date:16.05.2013 216

Case No.:169/33/82ALC4/2012

Party Name:FRESENIUS KABI ONCOLOGY LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01316/AM13/ RLA File :05/23/040/00238/AM13/ Lic.No/Date:0510341172 18.12.2012 Defer Date:16.05.2013 217

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

Party Name:MYLAN LABORATORIES LIMITED 18.04.2013 Status:Case Approved HQ File :01/82/050/01229/AM13/ RLA File :09/24/040/00421/AM13/ Lic.No/Date:0910054540 18.12.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/72/2013PI(Norms) dated 1.4.2013, 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 Quinapril HCL 1 kg 1. N(1(S)Ethoxy Carbonyl3Phentyl) LAlmine 0.88 kg 2. TIQBenzyl Ester PTSA Salt (Benzyl (S) 1,2,34Tetrahydro3 Isoquinoline 1.263 kg 3. Methylene Dichlroide 10.21 kg 4. 1,3Dicyclohexyl carbomide 0.59 kg 5. HOBT (Hydroxy Benzotriazole) 0.39 kg 6. Triethylamine 0.144 kg 7. Tetrahydrofuran 5.91 kg 8. Iso Propyl Ether 0.171 kg 9. Acetonitrile 0.114 kg 218

Case No.:184/33/82ALC4/2012

Party Name:RANBAXY LABORATORIES LTD 18.04.2013 Status:Case Deferred HQ File :01/82/050/01331/AM13/ RLA File :05/24/040/00347/AM13/ Lic.No/Date:0510341261 19.12.2012 Defer Date:16.05.2013 219

Case No.:44/33/82ALC4/2012

Party Name:CIPLA LIMITED 18.04.2013 Status:Case Approved

HQ File :01/82/050/01191/AM13/ RLA File :03/94/040/00796/AM13/ Lic.No/Date:0310717688 19.12.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 31/82 dated 2.11.2010, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Amoxicillin & Clavulanate Potassium for Suspension USP 75 ml pack 1. Amoxycillin Trihydrate 4.200 2. Clavulanate Potassium Syloid 2.3444 3. Silicon Dioxide (Syloid AL 1FP)NF 1.500 4. 115 CC N/M Pen RD Nat 28.0 GR SN (For MGP) As per packing policy 5 Cap 28/400 WHT CRC W/FS M1 As per packing policy Amoxicillin & Clavulanate Potassium for Suspension USP 100 ml pack 1. Amoxycillin Trihydrate 5.649 2. Clavulanate Potassium Syloid 3.126 3. Silicon Dioxide (Syloid AL 1FP)NF 2.00 4. 185 CC N/M Pen RND Material Natural 36GR SN (For MGP) As per packing policy 5. Cap 28/400 WHT CRC W/FS M1 As per packing policy Amoxicillin & Clavulanate Potassium for Suspension USP 150 ml pack 1. Amoxycillin Trihydrate 8.274 2. Clavulanate Potassium Syloid 4.6888 3. Silicon Dioxide (Syloid AL 1FP)NF 3.00 4 225 CC N/M Pen RD NAT.43.00 GRN (For MGP) As per packing policy 5. Cap 28/400 WHT CRC W/FS M1 As per packing policy 220

Case No.:53/31/82ALC4/2012

Party Name:S.KANT HEALTHCARE LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/01093/AM13/ RLA File :03/95/040/00702/AM13/ Lic.No/Date:0310717633 19.12.2012 Defer Date:16.05.2013

Case No.:55/31/82ALC4/2012

Party Name:S.KANT HEALTHCARE LTD. 18.04.2013 Status:Case Deferred

221 HQ File :01/82/050/01095/AM13/ RLA File :03/95/040/00701/AM13/ Lic.No/Date:0310717631 19.12.2012 Defer Date:16.05.2013 222

Case No.:182/33/82ALC4/2012

Party Name:INDSWIFT LABORATORIES LTD., 18.04.2013 Status:Case Deferred HQ File :01/82/050/01329/AM13/ RLA File :22/24/040/00055/AM13/ Lic.No/Date:2210013463 20.12.2012 Defer Date:16.05.2013 223

Case No.:186/33/82ALC4/2012

Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 18.04.2013 Status:Case Deferred HQ File :01/82/050/01333/AM13/ RLA File :07/24/040/00387/AM13/ Lic.No/Date:0710092620 20.12.2012 Defer Date:16.05.2013 224

Case No.:45/33/82ALC4/2012

Party Name:CONCEPT PHARMACEUTICALS LTD., 18.04.2013 Status:Case Deferred HQ File :01/82/050/01192/AM13/ RLA File :03/94/040/00421/AM13/ Lic.No/Date:0310717803 20.12.2012 Defer Date:16.05.2013 225

Case No.:46/33/82ALC4/2012

Party Name:IPCA LABORATORIES LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01193/AM13/ RLA File :03/94/040/00769/AM13/ Lic.No/Date:0310717816 20.12.2012 Defer Date:16.05.2013 226

Case No.:164/33/82ALC4/2012

Party Name:UNITED BIOTECH PVT.LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/01311/AM13/ RLA File :05/24/040/00360/AM13/ Lic.No/Date:0510341511 21.12.2012 Defer Date:16.05.2013 227

Case No.:135/33/82ALC4/2012

Party Name:VIRAT EXPORTS P.LTD., 18.04.2013 Status:Case Deferred HQ File :01/82/050/01282/AM13/ RLA File :05/24/040/00365/AM13/ Lic.No/Date:0510341550 24.12.2012 Defer Date:16.05.2013

228

Case No.:80/31/82ALC4/2012

18.04.2013 Status:Case Approved HQ File :01/82/050/01120/AM13/ RLA File :03/95/040/00753/AM13/ Lic.No/Date:0310718342 27.12.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011Ch. II dated 2.4.2013, 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 Copper Dibutyl Dithiocarbamate (CDBC) 1 kg 1. DINButylamine (Dibutylamine) 0.600 kg RA may take appropriate action as per the decision of Norms Committee 229

Case No.:113/33/82ALC4/2012

Party Name:RIDDHI PHARMA 18.04.2013 Status:Case Deferred HQ File :01/82/050/01260/AM13/ RLA File :34/24/040/00225/AM13/ Lic.No/Date:3410035749 28.12.2012 Defer Date:16.05.2013 230

Case No.:114/33/82ALC4/2012

Party Name:TRANSPEK INDUSTRY LIMITED 18.04.2013 Status:Case Approved HQ File :01/82/050/01261/AM13/ RLA File :34/24/040/00221/AM13/ Lic.No/Date:3410035747 28.12.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/6/2011Ch. II dated 22.4.2013, 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 4Chloro Butyryl Chloride Liquid 1 kg 1. Gamma Butyrolactone Liquid 0.820 kg 231

Case No.:53/33/82ALC4/2012

Party Name:AVIGNON EXIM PVT.LTD., 18.04.2013 Status:Case Deferred HQ File :01/82/050/01200/AM13/ RLA File :03/94/040/00820/AM13/ Lic.No/Date:0310718503 28.12.2012 Defer Date:16.05.2013 232

Case No.:136/33/82ALC4/2012

Party Name:HETERO LABS LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01283/AM13/ RLA File :09/24/040/00457/AM13/ Lic.No/Date:0910054624 31.12.2012 Defer Date:16.05.2013

p 233

Case No.:183/33/82ALC4/2012

Party Name:S.M. HERBALS PVT.LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/01330/AM13/ RLA File :05/24/040/00366/AM13/ Lic.No/Date:0510342102 01.01.2013 Defer Date:16.05.2013 234

Case No.:70/33/82ALC4/2012

Party Name:RAY CHEMICALS PRIVATE LIMITED, 18.04.2013 Status:Case Deferred HQ File :01/82/050/01217/AM13/ RLA File :07/24/040/00398/AM13/ Lic.No/Date:0710092831 01.01.2013 Defer Date:16.05.2013 Decision :It was decided to defer the case for 16.05.2013 for comments of Department ofC&PC. 235

Case No.:100/31/82ALC4/2012

Party Name:SUN PHARMA MEDICATION PVT. LTD. 18.04.2013 Status:Case Rejected HQ File :01/82/050/01140/AM13/ RLA File :03/95/040/00721/AM13/ Lic.No/Date:0310719057 02.01.2013 Defer Date: Decision :The firm has surrendered their licence and it was decided to close the case. 236

Case No.:129/33/82ALC4/2012

18.04.2013 Status:Case Deferred HQ File :01/82/050/01276/AM13/ RLA File :08/24/040/00336/AM13/ Lic.No/Date:0810117326 02.01.2013 Defer Date:16.05.2013 237

Case No.:130/33/82ALC4/2012

18.04.2013 Status:Case Deferred HQ File :01/82/050/01277/AM13/ RLA File :08/24/040/00161/AM13/ Lic.No/Date:0810117325 02.01.2013 Defer Date:16.05.2013 238

Case No.:165/33/82ALC4/2012

18.04.2013 Status:Case Deferred HQ File :01/82/050/01312/AM13/ RLA File :08/24/040/00257/AM13/ Lic.No/Date:0810117317 02.01.2013 Defer Date:16.05.2013

Case No.:171/33/82ALC4/2012

Status:Case

239 y , 18.04.2013 Deferred HQ File :01/82/050/01318/AM13/ RLA File :08/24/040/00256/AM13/ Lic.No/Date:0810117315 02.01.2013 Defer Date:16.05.2013 240

Case No.:52/33/82ALC4/2012

Party Name:DORFKETAL CHEMICALS INDIA PVT.LTD. 18.04.2013 Status:Case Approved HQ File :01/82/050/01199/AM13/ RLA File :03/94/040/00846/AM13/ Lic.No/Date:0310719099 02.01.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/176/2011Ch. II dated 21.3.2013, 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 Chemicals – Organic Mixture Trade Name 8114 R 1 kg 1. Glyoxylic Acid 50% 0.632 kg 2. Glyoxal 40% 0.200 kg 241

Case No.:74/33/82ALC4/2012

Party Name:MELZER CHEMICALS PVT. LTD 18.04.2013 Status:Case Deferred HQ File :01/82/050/01221/AM13/ RLA File :31/83/040/00168/AM13/ Lic.No/Date:3110056651 02.01.2013 Defer Date:16.05.2013 242

Case No.:124/33/82ALC4/2012

Party Name:GOPINATH CHEMTECH LTD., 18.04.2013 Status:Case Approved HQ File :01/82/050/01271/AM13/ RLA File :08/24/040/00341/AM13/ Lic.No/Date:0810117376 04.01.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/60/2012Ch II dated 22.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed 4,4Diamino Diphenyl Amine 2Sulphonic Acid 1 kg 1. Para Nitro aniline 0.950 kg 2. Para Nitro Chloro Benzene 1.290 kg 4. Soda Ash 2.800 kg 243

Case No.:40/31/82ALC4/2012

Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. 18.04.2013 Status:Case Deferred HQ Fil 01/82/050/01080/AM13/ RLA Fil 03/95/040/00777/AM13/ Li N /D t 0310719514 D f

243 HQ File :01/82/050/01080/AM13/ RLA File :03/95/040/00777/AM13/ Lic.No/Date:0310719514 07.01.2013 Defer Date:16.05.2013 244

Case No.:132/33/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01279/AM13/ RLA File :05/23/040/00410/AM13/ Lic.No/Date:0510342696 08.01.2013 Defer Date:16.05.2013 245

Case No.:134/33/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01281/AM13/ RLA File :05/23/040/00408/AM13/ Lic.No/Date:0510342701 08.01.2013 Defer Date:16.05.2013 246

Case No.:52/31/82ALC4/2012

Party Name:MELOG SPECIALITY CHEMICALS PVT. LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/01092/AM13/ RLA File :03/95/040/00708/AM13/ Lic.No/Date:0310719783 08.01.2013 Defer Date:16.05.2013 247

Case No.:74/31/82ALC4/2012

Party Name:MELOG SPECIALITY CHEMICALS PVT. LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/01114/AM13/ RLA File :03/95/040/00724/AM13/ Lic.No/Date:0310719791 08.01.2013 Defer Date:16.05.2013 248

Case No.:96/33/82ALC4/2012

Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 18.04.2013 Status:Case Deferred HQ File :01/82/050/01243/AM13/ RLA File :07/24/040/00419/AM13/ Lic.No/Date:0710092979 08.01.2013 Defer Date:16.05.2013 249

Case No.:23/33/82ALC4/2012

18.04.2013 Status:Case Approved HQ File :01/82/050/01170/AM13/ RLA File :03/95/040/00656/AM13/ Lic.No/Date:0310719988 09.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 19/82 dated 9.8.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per

g g , y p Export product Exp. Qty. Sl.No. Import items Qty. allowed Orthoxylene 1 MT. 1. Reformate 1.2565 MT 2. Relevant Catalyst and Chemicals used in manufacture of Orthoxylene CIF value limited to 0.90% of FOB value of exports 250

Case No.:101/31/82ALC4/2012

Party Name:PI INDUSTRIES LTD., 18.04.2013 Status:Case Approved HQ File :01/82/050/01141/AM13/ RLA File :13/24/040/00045/AM13/ Lic.No/Date:1310041867 10.01.2013 Defer Date: Decision :In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 15022/28/2012Ch. II dated 10.4.2013, 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 747Ether Chemical Name: 2chloro4 (methylsulfonyl)3 [{2,2,2 trifluoethoxy)methyl)] benzoic acid 1 kg 1. 3 chloro2Methyl Aniline 98% Min. 0.625 kg 2. Sodium Nitrite 97% Min. 0.350 kg 3. Sodium Methyl Mercaptide 20% Min. 3.126 kg 4. Methanol 99% Min. 2.600 kg 5. Bromine 99% Min. 0.650 kg 6. Acetonitrile 99% Min. 1.136 kg 7. Trifluoro Ethanol 98% Min. 1.112 kg 251

Case No.:117/33/82ALC4/2012

Party Name:MAHESHRAJ CHEMICALS PVT.LTD 18.04.2013 Status:Case Deferred HQ File :01/82/050/01264/AM13/ RLA File :08/24/040/00339/AM13/ Lic.No/Date:0810117495 10.01.2013 Defer Date:16.05.2013 252

Case No.:147/33/82ALC4/2012

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 18.04.2013 Status:Case Deferred HQ File :01/82/050/01294/AM13/ RLA File :07/24/040/00429/AM13/ Lic.No/Date:0710093054 11.01.2013 Defer Date: 16.5.2013 Decision : It was decided to defer the case for 16.5.2013 for comments of Department of Chemicals and Petrochemicals. 253

Case No.:203/33/82ALC4/2012

Party Name:SUBHASH CHEMICAL INDUSTRIES PVT LTD 18.04.2013 Status:Case Deferred HQ File :01/82/050/01350/AM13/ RLA File :31/83/040/00137/AM13/ Lic.No/Date:3110056802 11 01 2013 Defer Date:16 05 2013

11.01.2013 Date:16.05.2013 254

Case No.:4/29/82ALC4/2012

Party Name:GLAND PHARMA LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01036/AM13/ RLA File :09/24/040/00497/AM13/ Lic.No/Date:0910054771 11.01.2013 Defer Date:16.05.2013 255

Case No.:55/33/82ALC4/2012

18.04.2013 Status:Case Approved HQ File :01/82/050/01202/AM13/ RLA File :03/95/040/00800/AM13/ Lic.No/Date:0310720410 11.01.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011Ch. II dated 2.4.2013, 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 Zinc Piperidine Dithioc Carbamate (ZPD) 1 kg 1. Piperidine 0.542 kg 256

Case No.:56/33/82ALC4/2012

Party Name:MIDAS CARE PHARMACEUTICALS PVT LTD 18.04.2013 Status:Case Deferred HQ File :01/82/050/01203/AM13/ RLA File :03/95/040/00801/AM13/ Lic.No/Date:0310720417 11.01.2013 Defer Date:16.05.2013 257

Case No.:58/33/82ALC4/2012

Party Name:METROPOLITAN EXIMCHEM LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/01205/AM13/ RLA File :03/95/040/00788/AM13/ Lic.No/Date:0310720530 14.01.2013 Defer Date:16.05.2013 258

Case No.:199/33/82ALC4/2012

Party Name:INDO AMINES LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01346/AM13/ RLA File :03/94/040/00630/AM13/ Lic.No/Date:0310720784 15.01.2013 Defer Date:16.05.2013

259

Case No.:24/33/82ALC4/2012

Party Name:NEW ALLIANCE DYECHEM PVT. LTD., 18.04.2013 Status:Case Deferred HQ File :01/82/050/01171/AM13/ RLA File :03/95/040/00806/AM13/ Lic.No/Date:0310720729 15.01.2013 Defer Date:16.05.2013 260

Case No.:11/31/82ALC4/2012

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01051/AM13/ RLA File :04/24/040/00217/AM13/ Lic.No/Date:0410142687 18.01.2013 Defer Date:16.05.2013 261

Case No.:22/33/82ALC4/2012

18.04.2013 Status:Case Deferred HQ File :01/82/050/01169/AM13/ RLA File :03/95/040/00815/AM13/ Lic.No/Date:0310721364 18.01.2013 Defer Date:16.05.2013 262

Case No.:28/33/82ALC4/2012

18.04.2013 Status:Case Approved HQ File :01/82/050/01175/AM13/ RLA File :03/95/040/00814/AM13/ Lic.No/Date:0310721359 18.01.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011Ch. II dated 2.4.2013, 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 Methyl Eugenol 1 kg 1 Clove Leaf Oil (Eugenol Content 78%) 1.40 kg 263

Case No.:98/33/82ALC4/2012

Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 18.04.2013 Status:Case Approved HQ File :01/82/050/01245/AM13/ RLA File :07/24/040/00414/AM13/ Lic.No/Date:0710093152 18.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 20/82 dated 20.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Kanamycin Acid S lphate for Injectin 1 Vial 1. Kanamycin Acid Sulphate Sterile BP 1.39 gm

Sulphate for Injectin BP 1 gm, Vial Size 10 ml Sterile BP RA nay take appropriate action as per the decision of Norms Committee. 264

Case No.:99/33/82ALC4/2012

Party Name:PARAMOUNT AROMACHEM PVT.LTD., 18.04.2013 Status:Case Deferred HQ File :01/82/050/01246/AM13/ RLA File :05/24/040/00381/AM13/ Lic.No/Date:0510343720 18.01.2013 Defer Date:16.05.2013 265

Case No.:87/33/82ALC4/2012

Party Name:R L FINE CHEM 18.04.2013 Status:Case Deferred HQ File :01/82/050/01234/AM13/ RLA File :07/24/040/00428/AM13/ Lic.No/Date:0710093201 21.01.2013 Defer Date:16.05.2013 266

Case No.:88/33/82ALC4/2012

Party Name:R L FINE CHEM 18.04.2013 Status:Case Deferred HQ File :01/82/050/01235/AM13/ RLA File :07/24/040/00425/AM13/ Lic.No/Date:0710093199 21.01.2013 Defer Date:16.05.2013 267

Case No.:91/33/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01238/AM13/ RLA File :05/23/040/00415/AM13/ Lic.No/Date:0510343812 21.01.2013 Defer Date:16.05.2013 268

Case No.:102/33/82ALC4/2012

Party Name:SHIVA PHARMACHEM LTD, 18.04.2013 Status:Case Deferred HQ File :01/82/050/01249/AM13/ RLA File :34/24/040/00239/AM13/ Lic.No/Date:3410035900 22.01.2013 Defer Date:16.05.2013 Decision :vIt was decided to defer the case for 16.05.2013 for comments of Department of C&PC 269

Case No.:80/33/82ALC4/2012

Party Name:SARNA CHEMICALS PVT.LTD. 18.04.2013 Status:Case Approved HQ File :01/82/050/01227/AM13/ RLA File :52/24/040/00041/AM13/ Lic.No/Date:5210039377 Defer Date:

HQ File :01/82/050/01227/AM13/ RLA File :52/24/040/00041/AM13/ Lic.No/Date:5210039377 22.01.2013 Defer Date: Decision :In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/48/2008Ch. II dated 11.4.2013, 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 2(2Amino Ethoxy)2 Chloro Diethyl Sulfone/Ethermaine 1 kg 1. 2Amino Ethoxy Ethanol 0.874 kg 2. 2Mercapto Ethanol 0.800 kg 3. Caustic Soda (100%) 0.850 kg 270

Case No.:145/33/82ALC4/2012

Party Name:SHILPA MEDICARE LTD., 18.04.2013 Status:Case Deferred HQ File :01/82/050/01292/AM13/ RLA File :07/24/040/00454/AM13/ Lic.No/Date:0710093290 23.01.2013 Defer Date:16.05.2013 271

Case No.:146/33/82ALC4/2012

Party Name:SHILPA MEDICARE LTD., 18.04.2013 Status:Case Deferred HQ File :01/82/050/01293/AM13/ RLA File :07/24/040/00453/AM13/ Lic.No/Date:0710093292 23.01.2013 Defer Date:16.05.2013 Decision :It was decided to defer the case for 16.05.2013 for comments of Department of Pharmaaceuticals 272

Case No.:193/33/82ALC4/2012

Party Name:GLENMARK GENERICS LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01340/AM13/ RLA File :03/94/040/00800/AM13/ Lic.No/Date:0310721794 23.01.2013 Defer Date:16.05.2013 273

Case No.:158/33/82ALC4/2012

Party Name:FERMENTA BIOTECH LTD., 18.04.2013 Status:Deffered HQ File :01/82/050/01305/AM13/ RLA File :03/94/040/00683/AM13/ Lic.No/Date:0310721893 24.01.2013 Defer Date:16.05.2013 Decision : It was decided to call from the firm the production consumption data duly certified by Central Excise Authority. The case was deferred for 16.5.2013. 274

Case No.:38/33/82ALC4/2012

Party Name:R L FINE CHEM 18.04.2013 Status:Case Deferred HQ File :01/82/050/01185/AM13/ RLA File :07/24/040/00449/AM13/ Lic.No/Date:0710093355 28.01.2013 Defer Date:16.5.2013 Decision : It was decided to defer the case for 16 5 2013 for comments of Department of Pharmaceuticals

275

Case No.:64/33/82ALC4/2012

Party Name:GOPINATH CHEMTECH LTD., 18.04.2013 Status:Case Approved HQ File :01/82/050/01211/AM13/ RLA File :08/24/040/00361/AM13/ Lic.No/Date:0810117886 28.01.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/60/2012Ch II dated 22.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed 4,4Diamino Diphenyl Amine 2Sulphonic Acid 1 kg 1. Para Nitro aniline 0.950 kg 2. Para Nitro Chloro Benzene 1.290 kg 4. Soda Ash 2.800 kg 276

Case No.:153/33/82ALC4/2012

Party Name:ZYTEX BIOTECH PVT. LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/01300/AM13/ RLA File :03/95/040/00816/AM13/ Lic.No/Date:0310722230 29.01.2013 Defer Date:16.05.2013 Decision :It was decided to send a copy of application to Department of Biotechnology for their comments. The case was deferred for 16.05.2013. 277

Case No.:197/33/82ALC4/2012

Party Name:FERMENTA BIOTECH LTD., 18.04.2013 Status:Case Deferred HQ File :01/82/050/01344/AM13/ RLA File :03/94/040/00917/AM13/ Lic.No/Date:0310722266 29.01.2013 Defer Date:16.05.2013 Decision : The representative from Department of Pharmaceuticals in the meeting has assured the Chairman that he will send the written comments by the time minutes will be prepared. In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/105/2013PI(Norms) dated 1.5.2013, it was decided to call from the firm the following technical details: a) 2,4,6Colidine is not required from the cholesteryl stage. Technical justification for applying this. b) The firm has given the chemistry again from chloesteryl Acetate whereas they have applied cholesterol as starting material. The firm may, therefore, be advised to furnish complete technical details as per Appendix 33 from Cholesterol Stage. © Recovery of Chloestrol in the process may be quanitified along with copy of relevant technical literature. Copy of Post production visàvis actual consumption of inputs duly certified by Central Excise Authority maybe furnished.

Case No :201/33/82ALC4/2012

Party Name:ENALTEC LABS PVTLTD Meet No/Date:2/82ALC4/2013 Status:Case

278

Case No.:201/33/82ALC4/2012

Party Name:ENALTEC LABS PVT.LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/01348/AM13/ RLA File :03/94/040/00933/AM13/ Lic.No/Date:0310722303 29.01.2013 Defer Date:16.05.2013 Decision :It was decided to defer the case for 16.05.2013 for comments of Department of pharmaceuticals 279

Case No.:79/33/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01226/AM13/ RLA File :05/23/040/00430/AM13/ Lic.No/Date:0510344338 29.01.2013 Defer Date:16.05.2013 280

Case No.:154/33/82ALC4/2012

Party Name:SATYAM PHARMA CHEM PVT LTD 18.04.2013 Status:Case Deferred HQ File :01/82/050/01301/AM13/ RLA File :03/95/040/00787/AM13/ Lic.No/Date:0310722449 30.01.2013 Defer Date:16.05.2013 281

Case No.:60/33/82ALC4/2012

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 18.04.2013 Status:Case Deferred HQ File :01/82/050/01207/AM13/ RLA File :07/24/040/00430/AM13/ Lic.No/Date:0710093432 30.01.2013 Defer Date:16.05.2013 282

Case No.:152/33/82ALC4/2012

18.04.2013 Status:Case Deferred HQ File :01/82/050/01299/AM13/ RLA File :08/24/040/00363/AM13/ Lic.No/Date:0810117991 31.01.2013 Defer Date:16.05.2013 Decision :It was decided to defer the case for 16.05.2013 for comments of Department of pharmaceuticals 283

Case No.:2/31/82ALC4/2012

Party Name:GRANULES INDIA LIMITED 18.04.2013 Status:Case Approved HQ File :01/82/050/01042/AM13/ RLA File :09/24/040/00511/AM13/ Lic.No/Date:0910054886 01.02.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 28/82 dated 11.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Compresso Cotrim 90 (Sulfamethoxazole 1 kg 1. Sulfamethoxazole 0.750 kg 2. Trimethoprim 0.150 kg 3 Pregelatinised starch 0 043 kg

(Sulfamethoxazole and Trimethoprim Granules DC) 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 284

Case No.:209/33/82ALC4/2012

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01356/AM13/ RLA File :03/95/040/00804/AM13/ Lic.No/Date:0310722788 04.02.2013 Defer Date:16.05.2013 Decision :It was decided to defer the case for 16.05.2013 for comments of Department of pharmaceuticals 285

Case No.:61/33/82ALC4/2012

Party Name:DISHMAN PHARMACEUTICALS & CHEMICALS LTD 18.04.2013 Status:Case Deferred HQ File :01/82/050/01208/AM13/ RLA File :08/24/040/00184/AM13/ Lic.No/Date:0810118080 05.02.2013 Defer Date:16.05.2013 286

Case No.:67/33/82ALC4/2012

Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 18.04.2013 Status:Case Deferred HQ File :01/82/050/01214/AM13/ RLA File :07/24/040/00461/AM13/ Lic.No/Date:0710093544 05.02.2013 Defer Date:16.05.2013 287

Case No.:1/1/82ALC4/2013

Party Name:ARJUN CHEMICALS PVT. LTD., 18.04.2013 Status:Case Approved HQ File :01/82/050/01359/AM13/ RLA File :04/24/040/00245/AM13/ Lic.No/Date:0410143108 06.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/150/2011Ch. II dated 18.4.2013, 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 KEYMIDEAKDAlkyl Ketene Dimer Emulsion 1 kg 1 AKDAlkyl Ketene Dimer 0.100 kg 2. SOLBOND C40SCationic Potato Starch 0.070 kg

Case No.:20/33/82ALC4/2012

Party Name:SARNA CHEMICALS PVT.LTD. 18.04.2013 Status:Case Approved HQ File :01/82/050/01167/AM13/ RLA File :52/24/040/00042/AM13/ Lic.No/Date:5210039408 06.02.2013 Defer Date:

288 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/48/2008Ch. II dated 11.4.2013, 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 2(2Amino Ethoxy)2 Chloro Diethyl Sulfone/Ethermaine 1 kg 1. 2Amino Ethoxy Ethanol 0.874 kg 2. 2Mercapto Ethanol 0.800 kg 3. Caustic Soda (100%) 0.850 kg 289

Case No.:62/33/82ALC4/2012

Party Name:MINAL INTERMEDIATES 18.04.2013 Status:Case Approved HQ File :01/82/050/01209/AM13/ RLA File :08/24/040/00385/AM13/ Lic.No/Date:0810118226 06.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/112/2012Ch. II dated 12.4.2013, 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 1 Phenyl 3 Carbethoxy 5 Pyrazolone 1 kg 1 Aniline Oil 0.673 kg 2. Sodium Nitrite 0.462 kg 3. Sodium Metal 0.123 kg 290

Case No.:83/1/82ALC4/2013

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 18.04.2013 Status:Case Approved HQ File :01/82/050/01441/AM13/ RLA File :03/94/040/00811/AM13/ Lic.No/Date:0310723118 06.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/29/2011Ch. II dated 4.4.2013, 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 4Chloro Benzyl Cyanide 75% in N Butyl Acetate or Para Chloro Benzyl Cyanide 75% in N Butyl Acetate 1 kg 1. Para Chloro Benzyl Cyanide 0.787 kg 2. NButyl Acetate 0.262 kg 291

Case No.:100/1/82ALC4/2013

Party Name:GLENMARK GENERICS LIMITED 18.04.2013 Status:Case Rejected HQ File :01/82/050/01458/AM13/ RLA File :03/94/040/00894/AM13/ Lic.No/Date:0310723234 07.02.2013 Defer Date: Decision :Withdrawn as the case was already approved in 1/82 meeting dated 4.4.2013.

Case No.:139/33/82ALC4/2012

Party Name:HPL ADDITIVES Meet No/Date:2/82ALC4/2013 Status:Case

292

Case No.:139/33/82 ALC4/2012

Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:2/82 ALC4/2013 18.04.2013 Status:Case Approved HQ File :01/82/050/01286/AM13/ RLA File :05/23/040/00446/AM13/ Lic.No/Date:0510345185 07.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/7/2011/Ch. II dated 26.3.2013, 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 1,3,5Trimethyl2,4,6 TRIS (3,5DiTert Butyl4 Hydroxybenzyl) Benzene (Kinox 30) 1 kg 1 2,6 Ditertiary butyl Phenol 1.12 kg 2. Paraformaldehyde (PF) 96% 0.172 kg 3. Mesitylene 0.198 kg 4. Methylenedichloride 1.00 kg 5. Methanol 1.00 kg 293

Case No.:151/33/82ALC4/2012

Party Name:FORACE POLYMERS (P) LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/01298/AM13/ RLA File :05/23/040/00459/AM13/ Lic.No/Date:0510345208 07.02.2013 Defer Date:16.05.2013 Decision :It was decided to defer the case for 16.05.2013 for comments of Petrochemical Division of Department of Chemicals & Petrochemicals. 294

Case No.:210/33/82ALC4/2012

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01357/AM13/ RLA File :03/95/040/00836/AM13/ Lic.No/Date:0310723378 07.02.2013 Defer Date:16.05.2013 Decision :It was decided to remind the firm to furnish the technical details as per Appendix 33. The case was deferred for 16.05.2013. 295

Case No.:93/31/82ALC4/2012

Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01133/AM13/ RLA File :03/94/040/00926/AM13/ Lic.No/Date:0310723236 07.02.2013 Defer Date:16.05.2013 296

Case No.:48/1/82ALC4/2013

Party Name:SOMU ORGANO CHEM PVT.LTD., 18.04.2013 Status:Case Approved HQ File :01/82/050/01406/AM13/ RLA File :07/24/040/00471/AM13/ Lic.No/Date:0710093635 08.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/151/2011Ch. II dated 21.3.2013, 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 1,3Cyclohexanedione (Cyclohexane1,3 Dione) Dihydro 1 kg 1 Resorcinol 1.24 kg

Dione) Dihydro Resorcinol 297

Case No.:84/33/82ALC4/2012

Party Name:INDO PHYTO CHEMICALS PVT LTD 18.04.2013 Status:Case Approved HQ File :01/82/050/01231/AM13/ RLA File :05/23/040/00449/AM13/ Lic.No/Date:0510345251 08.02.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/102/2013PI(Norms) dated 25.4.2013, 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 Lynestrenol Bulk Drug 1 kg 1. Sitolactone Intermediate 1.95 kg 2. 5Chloro2Pentanone Reagent 1.81 kg 3. Tetrahydrofuran Solvent 5.80 kg 4. Pyridine Reagent 0.87 kg 298

Case No.:161/33/82ALC4/2012

Party Name:RONAK CHEMICALS 18.04.2013 Status:Case Approved HQ File :01/82/050/01308/AM13/ RLA File :34/24/040/00257/AM13/ Lic.No/Date:3410036096 12.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/5/2013Ch. II dated 12.4.2013, 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 Export Quantity S.No Import Product Quantity Allowed Barbituric Acid 1 kg 1. DiEthyl Malonate 1.46 kg 2. Sodium Metal 0.179 kg 299

Case No.:163/33/82ALC4/2012

Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 18.04.2013 Status:Case Deferred HQ File :01/82/050/01310/AM13/ RLA File :03/94/040/00972/AM13/ Lic.No/Date:0310724040 13.02.2013 Defer Date:16.05.2013

Case No.:68/33/82ALC4/2012

Party Name:INDO PHYTO CHEMICALS PVT LTD 18.04.2013 Status:Case Approved HQ File :01/82/050/01215/AM13/ RLA File :05/23/040/00456/AM13/ Lic.No/Date:0510345898 Defer Date:

300 Q 13.02.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/102/2013PI(Norms) dated 25.4.2013, 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 Allylestrenol Bulk Drug 1 kg 1. Sitolactone Intermediate 1.95 kg 2. 5Chloro2Pentanone Reagent 1.81 kg 3. Tetrahydrofuran Solvent 5.80 kg 4. Pyridine Reagent 0.87 kg 301

Case No.:2/33/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED 18.04.2013 Status:Case Approved HQ File :01/82/050/01149/AM13/ RLA File :05/23/040/00474/AM13/ Lic.No/Date:0510347744 28.02.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 16 dated 23.8.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Valacyclovir Hydrochloride Tablets 500 mg (each tablet contains valacyclovir HCL equivalent to valacyclovir 500 mg) 1 tablet 1. Valacyclovir HCL BP/USP 556 mg/tablet Valacyclovir Hydrochloride Tablets 1000 mg (Each tablet contains valacyclovir HCL equivalent to valacyclovir 1000 mg) 1 tablet 1. Valacyclovir HCL BP/USP 1112 mg/tablet 302

Case No.:3/33/82ALC4/2012

Party Name:UNITED BIOTECH PVT.LTD. 18.04.2013 Status:Case Deferred HQ File :01/82/050/01150/AM13/ RLA File :05/24/040/00448/AM13/ Lic.No/Date:0510347967 01.03.2013 Defer Date:16.05.2013 Decision :It was decided to defer the case for 16.05.2013 for comments of Department of pharmaceuticals

Case No.:33/2/82ALC4/2013

Party Name:MOREPEN LABORATORIES LTD & Meet No/Date:2/82ALC4/2013 Status:Case

303

Case No.:33/2/82 ALC4/2013

Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION Meet No/Date:2/82 ALC4/2013 18.04.2013 Status:Case Deferred HQ File :01/82/050/01480/AM13/ RLA File :05/24/040/00481/AM13/ Lic.No/Date:0510350279 26.03.2013 Defer Date:16.05.2013 Decision :It was decided to defer the case for 16.05.2013 for comments of Department of pharmaceuticals 304

Case No.:34/2/82ALC4/2013

Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 18.04.2013 Status:Case Approved HQ File :01/82/050/01481/AM13/ RLA File :05/24/040/00482/AM13/ Lic.No/Date:0510350280 26.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 21.82 dated 4.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Rosuvastatin Calcium 1 kg. 1. (4RCis) 6[(Acetyloxy) Methyl]2,2 Dimethyl1,3Dioxane4Acetic Acid1,1 Dimethylethyl Ester (DS) 1.871 kg 2. 4(4Fluorophenyl)6Isopropyl2[(N MethylN Methylsulphonl)Amino] Pyrimidine 5YLMethanol (Z7) 1.871 kg RA concerned may take further necessary action as per above decision of NC. 305

Case No.:1/2/82ALC4/2013

Party Name:METROPOLITAN EXIMCHEM LTD. 18.04.2013 Status:Case Approved HQ File :01/82/050/00001/AM14/ RLA File :03/95/040/00994/AM13/ Lic.No/Date:0310730417 04.04.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 22/82 dated 18.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg MR3 (2,4 Dihlydroxy 3 Methyl) Phenyl, 1,3,5Triazine) 1 kg 1. 2. 3. 2Methyl Resorcinol Cyanuric Chloride Sulfolane 1.140 kg 0.479 kg 1.800 kg

Case No.:30/2/82ALC4/2013

Party Name:RANBAXY LABORATORIES LTD 18.04.2013 Status:Case Approved HQ File :01/82/050/00031/AM14/ RLA File :05/24/040/00473/AM13/ Lic.No/Date:0510350966 08.04.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no 31/82 dated 2 11 2010 it was decided to ratify norms under Para 4 7 of HBP v1 as

306 Decision : In the light of earlier decision taken in meeting no. 31/82 dated 2.11.2010, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Volini Gel 30 gm tube (Each tube contains 1.5 gm Racementhol) 1 No. 1. Raccmenthol 1.575 gm/30 gm tube RA may take appropriate action as per the decision of Norms Committee. Party to be advised to apply for fixation of SION through EPC. Outside Agenda No. 1 M/s Dorf Ketal Chemicals (I) pvt. Limited 01/82/050/00369/AM 10 01/82/050/1512/AM 09/DES III RLA File No. 03/94/040/00280/AM 10 03/94/040/00838/AM 09 0310529903 dated 21.7.2009 0310501369 dated 6.1.2009 Decision: The norms for the above mentioned advance licenses were ratified by NC in its meeting no. 10 dated 9.6.2009 and meeting no.25 dated 15.9.2009 respectively. It noticed that inadvertently the norms for the import items sodium Diphenyl Oxide Disulfonate and Alkoxylated Alkanolamine got interchanged. The Committee decided to amend the same as per details given below: Export product Export Qty. Sl.No. Import items Qty. allowed Solid Weฺng Agent (RNB‐ 51232/SR 1165 Containing: 50% of Mono Ethylene Glycol 18% of Sodium Diphenyl Oxide Disulfonate 2% of Alkoxylated Alkanolamine 1 Kg. 1. Mono Ethylene Glycol 0.500 kg 2. Sodium Diphenyl Oxide Disulfonate 0.020 kg 3. Alkoxylated Alkanolamine 0.180 kg Outside Agenda No. 2 M/s. Indian Immunologicals Limited 01/82/050/01379/AM 11 01/82/050/01259/AM 11/DES III Advance License NO.

0910042621 dated 6.7.2010 0910042621 dated 6.7.2010 Decision: The norms for the above mentioned advance licenses were ratified by NC in its meeting no. 20/82 dated 16.8.2011. It was decided to amend the export quantity from “1 Unit (1000 vials) to 1 unit (1000 doses). Rest of the minutes would remain same. Date:29.04.2013 Place:New Delhi Lalita Maini Foreign Trade Development Officer

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Para 4.7 Decision

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