DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi 0
Para 4.7 Decision
MEETING NUMBER : 44/82ALC4/2011 MEETING DATE : 31.01.2012 The Meeting No.44/82 in the year 201112 to consider the cases under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to products falling in Chapter 29 and 30 was actually held on 31.01.2012 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present: 1. Shri Jasbir Singh, Consultation, Department of C&PC 2. Shri D.N. Mathur, Consultation, Department of Pharmaceuticals 3. Ms.Lalita Maini, FTDO At the outset, minutes of Norms Committee Meeting No.43/82 dated 24.01.2012 were ratified by the Committee.
Case No.B 462
M/s. DSM AntiInfectives India Limited Norms Committee Meeting No.44/AM12 dated F.No. 01/82/050/01305/AM 11/DES III F.No 01/82/050/01440/AM 11/DES III F.No. 01/82/050/01309/AM 11/DES III F.No 01/82/050/01109/AM 11/DES III Meeting Date:31.01.2012 Adv. Lic. No. 2210010237 dated 4.8.2010 Adv. Lic. No. 2210010247 dated 5.8.2010 Adv. Lic. No. 2210010202 dated 21.7.2010 Adv Lic. No. 2210010203 dated 21.7.2010 R.A F.No, 22/24/040/00021/AM 11 RA F.No. 22/24/040/00024/AM 11 RA F.No. 22/24/040/00016/AM 11 RA F No. 22/24/040/00017/AM 11 Decision: The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 28.2.2012 for comments of technical authority.
Case No.B 463
M/s. DSM AntiInfectives India Limited F.No. 01/82/050/01319/AM 11/DES III F.No 01/82/050/01106/AM 11/DES III Adv. Lic. No. 2210010536 dated 18.10.2010 Adv. Lic. No. 2210010163 dated 9.7.2010 R.A F.No, 22/24/040/00048/AM 11 RA F.No. 22/24/040/00020/AM 11
Case No.B 464
M/s. Vivimed Labs Limited F.No. 01/83/050/00443/AM 07/DES III Adv. Lic. No. 0910026921 dated 20.07.2006 R.A F.No, 09/24/040/00103/AM07
Case No.B 465
M/s. Siddhi Vinayaka Spechem Pvt. Ltd. F.No. 01/82/050/01548/AM 11/DES IIII Adv. Lic. No. 0710076995 dated 28.01.2011 R.A F.No07/24/040/00386/AM 11
Case No.B 466
M/s. Ultratech India Limited F.No. 01/82/050/00446/AM 08/DES III F.No 01/82/050/00119/AM 09/DES III F.No. 01/82/050/00259/AM 12/DES III Adv. Lic. No. 0310450707 dated 19.11.2007 Adv. Lic. No. 031045922 dated 30.01.2008 Adv. Lic. No. 0310631866 dated 19.06.2011 R.A F.No, 03/95/040/00813/AM 08 RA F.No 03/95/040/01080/AM 08 RA F.No 03/95/040/00078/AM 12
Case No.B 467
M/s. Shasun Pharmaceuticals Ltd. F.No. 01/82/162/01146/AM 11/DES III present in the meeting decided to call from the firm production and consumption duly certified by Central Excise Authority for the last three years and also remind the firm to send their application through Pharmexcil alongwith All Industry data. Accordingly, the case has been deferred for 28.2.2012.
Case No.B 468
M/s. Aqua Pharma Limited, Pune
F.No. 01/87/050/00665/AM 11/DES III Adv. Lic. No. 3110043418 dated 31.05.2010 RA No. 31/24/040/00026/AM 11
Case No.B 469
M/s. Shasun Pharmaceuticals Limited F.No. 01/82/162/00261/AM 12/DES III present in the meeting decided to call from the firm the production and consumption data certified by Central Excise Authority. Accordingly, the case has been deferred for 28.2.2012.
Case No.B 470
M/s. Shasun Pharmaceuticals Limited F.No. 01/82/162/00267/AM 12/DES III present in the meeting decided to call from the firm the production and consumption data certified by Central Excise Authority. Accordingly, the case has been deferred for 28.2.2012.
Case No.B 471
M/s. Divis Laboratories Limited F.No. 01/82/162/00153/AM 12/DES III F.No 01/82/162/00158/AM 12/DES III F.No. 01/82/162/00160/AM 12/DES III F.No 01/82/162/00161/AM 12/DES III F.No. 01/82/162/00162/AM 12/DES III F.No 01/82/162/00163/AM 12/DES III F.No. 01/82/162/00165/AM 12/DES III F.No 01/82/162/00166/AM 12/DES III Decision: . The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to defer the case for 28.2.2012 for comments of technical authority
Case No.B 472
M/s. Divis Laboratories Limited F.No. 01/82/162/00177/AM 12/DES III F.No 01/82/162/00178/AM 12/DES III
F.No. 01/82/162/00179/AM 12/DES III F.No 01/82/162/00180/AM 12/DES III F.No. 01/82/162/00182/AM 12/DES III F.No 01/82/162/00183/AM 12/DES III F.No. 01/82/162/00184/AM 12/DES III F.No 01/82/162/00185/AM 12/DES III F.No 01/82/162/00186/AM 12/DES III F.No 01/82/162/00187/AM 12/DES III F.No 01/82/162/00188/AM 12/DES III F.No 01/82/162/00189/AM 12/DES III F.No 01/82/162/00190/AM 12/DES III F.No 01/82/162/00191/AM 12/DES III F.No 01/82/162/00192/AM 12/DES III F.No 01/82/162/00193/AM 12/DES III F.No 01/82/162/00194/AM 12/DES III Decision: . The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to defer the case for 28.2.2012 for comments of technical authority
Case No.B 473
M/s. Zenith Dyeintermediates Ltd. F.No. 01/82/162/00563/AM 12/DES III Adv. Lic. No. 0310645518 dated 1.8.2011 RA F.No. 03/95/040/00310/AM 12
Case No.B 474
M/s. Balaji Amines Ltd. F.No. 01/82/050/00458/AM 12/DES III Adv. Lic. No. 3110048921 dated 28.6.2011 RA F.No. 31/83/040/00053/AM 12
Case No.B 475
M/s. Elfa Laboratories F.No. 01/82/162/00353/AM 12/DES III Adv. Lic. No. 0510215792 dated 4.2.08 RA F.No. 05/25/40/00483/AM 08 present in the meeting decided to call the firm for personal hearing on 28.2.2012 along with complete application, Drug Manufacturing License and Justification/working of the norms applied.
Case No.B 476
M/s. Euromed Health Pvt. Ltd. F.No. 01/82/50/00712/AM 11/DES III Adv. Lic. No. 3510030697 dated 21.06.11 RA F.No. 35/83/040/00018/AM 11 Decision: The Committee considered the case as per agenda and in the light of written comments received from Department of Industrial Policy and Promotion vide their letter dated 30.1.2012 and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v 1 as per details below or as applied by firm whichever is lower: Export Product Exp. Qty. S.No Import Items (in Kgs) Qty. Allowed (Kgs) Absorbent Medical Pad 10x10 CMS. Packed with Medical paper) 12700.00 Kg Absorbent Medical Pad 10x10 CMS 5066.00 The firm has claimed 1% wastage, which is justified. RA may accordingly take appropriate action. 1
Case No.:24/28/82ALC4/2011
Party Name:SARNA CHEMICALS PVT.LTD. Meet No/Date:44/82ALC4/2011 31.01.2012 Status:Case Deferred HQ File :01/82/050/00794/AM12/ RLA File :03/88/040/00005/AM10/ Lic.No/Date:0310517425 27.04.2009 Defer Date: 28.2.2012 Decision : The Committee considered the case as per agenda and in light of the written comments received from the Department of Chemicals and Petrochemicals vide their letter No. 14010/48/2008Ch. II dated 10.10.2011 and in consultation with the technical authority, decided to call from the firm the following information : Manufacturing process in brief. Balanced chemical reaction showing all the reactants, product and by product with their molecular formula and molecular weight. Complete material balance with the formation of isomers. Stagewise % yield on molecular weight basis alongwith justification supported with authentic printed technical literature. Quantity of solvents charged, recovered and loss in process for per kg of export item along with justification. Production of export item for the past 3 years and corresponding consumption of each input duly certified by CA. Accordingly, the case has been deferred for 28.2.2012 2
Case No.:44/39/82ALC4/2010
Party Name:ASTRIX LABORATORIES LTD., 31.01.2012 Status:Case Deferred HQ File :01/82/050/01125/AM11/ RLA File :09/24/040/00301/AM10/ Lic.No/Date:0910040874 09.02.2010 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to
defer the case for 28.2.2012 for comments of technical authority. 3
Case No.:48/14/82ALC4/2010
Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 31.01.2012 Status:Case Approved HQ File :01/82/050/00410/AM11/ RLA File :03/94/040/00933/AM10/ Lic.No/Date:0310570355 20.04.2010 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in 30/82 meeting dated 26.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Bis Mercaptoethyl Isophthalimide 1 kg 1. Cysteamine HCL 1.07 kg 2. Isophthaloyl Chloride 0.735 kg 3. Triethylamine 1.90 kg RA may take appropriate action as per the decision of Norms Committee. 4
Case No.:11/5/82ALC4/2010
Party Name:PARABOLIC DRUGS LTD., 31.01.2012 Status:Case Approved HQ File :01/82/050/00045/AM11/ RLA File :05/24/040/00017/AM11/ Lic.No/Date:0510262860 22.04.2010 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorites present in the meeting, decided to ratify norms under Para 4.7 of HBP v1 as per comparative data available, as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Piperacillin Sodium+ Tazobactum Sodium (8:1) (Sterile, for injection) 1 kg 1. 2 3 6APA Methylene Chloride Triethylamine 0.4837 kg 2.70 kg 0.466 kg
4 5 6 7 8 9 10 11 (R){[4Ethyl2,3dioxopiperazin1yl) carbonyl]amino}phenylacetic acid [EPCP(Side Chain)] [EPCP (Side Chain)] Pyridine Pivaloyal Chloride Activated Carbon Ethyl Acetate Hydrochloride Acid HCL Tazobactum Acid Sodium Carbonate 0.658 kg 0.002 kg 0.251 kg 0.05 kg 2.36 kg Not an importable item 0.113 kg 0.110 kg 5
Case No.:62/15/82ALC4/2010
Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHE 31.01.2012 Status:Case Approved HQ File :01/82/050/00499/AM11/ RLA File :05/23/040/00041/AM11/ Lic.No/Date:0510265059 31.05.2010 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting, as per SION A412 , decided to ratify norms under Para 4.7 of HBP v1, as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed (mg per tablet) Atorvastatin Tablets 5 mg 1 no of tablet 1 2 3 4 5 6 Atorvastatin Calcium Microcrystallin Cellulose (PH101) Calmellose Calcium (ECG 505) Hydroxypropylcellulose (SSL) Magnesium Oxide (XP103) Mircrocrystalline Cellulose (KG1000) 5.42 12.48 16.00 0.700 15.00 2.00
7 Magnesium Stearate 0.4 Atorvastatin Tablets 10 mg 1 no of tablet 1 2 3 4 5 6 7 Atorvastatin Calcium Microcrystallin Cellulose (PH101) Calmellose Calcium (ECG 505) Hydroxypropylcellulose (SSL) Magnesium Oxide (XP103) Mircrocrystalline Cellulose (KG1000) Magnesium Stearate 10.84 8.66 20.00 1.00 16.00 Not applicable 0.5 6
Case No.:71/15/82ALC4/2010
Party Name:NECTAR LIFESCIENCES LIMITED, 31.01.2012 Status:Case Deferred HQ File :01/82/050/00508/AM11/ RLA File :22/24/040/00010/AM11/ Lic.No/Date:2210010065 14.06.2010 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 7
Case No.:67/22/82ALC4/2010
Party Name:MADHUKAR HORMONES & STERODIS [P] LTD. 31.01.2012 Status:Case Deferred HQ File :01/82/050/00720/AM11/ RLA File :03/95/040/00210/AM11/ Lic.No/Date:0310581119 29.06.2010 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to remind the firm to furnish consumption and production data duly certified by Central Excise Authority. Accordingly, the case has been deferred for 28.2.2012. 8
Case No.:12/15/82ALC4/2010
Party Name:MEDREICH LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/00449/AM11/ RLA File :07/24/040/00099/AM11/ Lic.No/Date:0710072561 29.06.2010 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to remind the firm to furnish consumption and production data duly certified by Central Excise Authority. Accordingly, the case has been
deferred for 28.2.2012. 9
Case No.:63/39/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 31.01.2012 Status:Case Approved HQ File :01/82/050/01144/AM11/ RLA File :09/24/040/00116/AM11/ Lic.No/Date:0910042624 06.07.2010 Defer Date: Decision : Commi컦�ee considered case as per agenda and in light of wri컦�en comments forwarded by Department of Pharmaceu솗cals vide their OM No. 35011/221/2010‐PI(Norms) dated 25.11.2011 and in consulta솗on with technical authority present in mee솗ng, decided to ra솗fy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg Pyronaridine Tetra Phosphate 1 kg 1 2 3 4 5 6 7,10‐Dichloro‐2‐Methoxy[B][1,5]Naphthyridine Dichloro Methane Methanol N‐Hexane Pyrrolidine Toluene 1.34 4.54 4.04 0.14 0.41 3.83 10
Case No.:122/40/82ALC4/2010
Party Name:SURYA PHARMACEUTICAL LTD 31.01.2012 Status:Case Deferred HQ File :01/82/050/01321/AM11/ RLA File :22/24/040/00025/AM11/ Lic.No/Date:2210010236 03.08.2010 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting, decided to call from the firm complete technical details as per Appendix 33 and also production and consumption data duly certified by Central Excise Authority. Accordingly, the case has been deferred for 28.2.2012. 11
Case No.:15/31/82ALC4/2010
Party Name:R L FINE CHEM 31.01.2012 Status:Case Deferred HQ File :01/82/050/00940/AM11/ RLA File :07/24/040/00156/AM11/ Lic.No/Date:0710073569 12.08.2010 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to defer the case for 28.2.2012 for comments of technical authority
12
Case No.:57/41/82ALC4/2010
Party Name:LUPIN LIMITED 31.01.2012 Status:Case Approved HQ File :01/82/050/01405/AM11/ RLA File :03/95/040/00382/AM11/ Lic.No/Date:0310589551 26.08.2010 Defer Date: Decision : Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/08/2010PI(Norms) dated 28.11.2011, and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Exp. Qty. S.No Import Item Qty. allowed STERILE CEFTRIAXONE SODIUM (Non Infringing) (STERILE CEFTRIAXONE SODIUM 275 mg/250 mg) 3000 kg 1. ETHYL ACETATE 2.181kg/kg of Sterile Ceftriaxone Sodium 2. METHYLENE CHLORIDE 2.00kg/kg of Sterile Ceftriaxone Sodium 3. SODIUM HYDROSULPHITE 0.0049 kg/kg of Sterile Ceftriaxone Sodium 4. 7 AMINO CEPHALOSPORANIC ACID 0.668 kg/kg of Sterile Ceftriaxone Sodium 5. 2,5,DIHYDRO6HYDROXY3 MERCAPTO2METHYL5OXO 1,2,4TRIAZENE 0.360 kg/kg of Sterile Ceftriaxone Sodium 6. BORON TRIFLUORIDE GAS 0.611 kg/kg of Sterile Ceftriaxone Sodium 7. ACETONITRILE 2.60 kg/kg of Sterile
Ceftriaxone Sodium 8. ACETONE 11.50 kg/kg of Sterile Ceftriaxone Sodium 9. ACTIVATED CARBON 0.100 kg/kg of Sterile Ceftriaxone Sodium 10. TETRA HYDROFURAN 1.23 kg/kg of Sterile Ceftriaxone Sodium 11. FORMIC ACID 3.158 kg/kg of Sterile Ceftriaxone Sodium 12. HEXAMETHYL DISILAZANE 0.540 kg/kg of Sterile Ceftriaxone Sodium 13. TRIETHYL AMINE 0.514 kg/kg of Sterile Ceftriaxone Sodium 14. PHOSPHOROUS PENTACHLORIDE 0.474 kg/kg of Sterile Ceftriaxone Sodium 15. ISOPROPYL ALCOHOL 0.400 kg/kg of Sterile Ceftriaxone Sodium 16. THIOUREA 0.180 kg/kg of Sterile Ceftriaxone Sodium 17. ETHYLENE DIAMINE TETRA ACETIC ACID DISODIUM SALT 0.040 kg/kg of Sterile
(E.D.T.A DI SODIM) Ceftriaxone Sodium 18. SODIUM BICARBONATE 0.511 kg/kg of Sterile Ceftriaxone Sodium 19. TRIMETHYL CHLOROSILANE 0.079 kg/kg of Sterile Ceftriaxone Sodium 20. SODIUM 2ETHYL HEXANOATE 0.684 kg/kg of Sterile Ceftriaxone Sodium 21. 4BROMO2METHOXYIMINO3 OXO BUTYRIC ACID (BROMO ACID) 0.485 kg/kg of Sterile Ceftriaxone Sodium RA concerned may take further necessary action as per above decision of NC. 13
Case No.:32/23/82ALC4/2010
Party Name:SUVEN LIFE SCIENCES LIMITED 31.01.2012 Status:Case Approved HQ File :01/82/050/00800/AM11/ RLA File :09/24/040/00211/AM11/ Lic.No/Date:0910043338 31.08.2010 Defer Date: Decision : The Committee considered the case as per agenda and in the light of earlier decision taken in meeting No. 41/82 dated 10.1.2012 and consultation with the technical authorities present in the meeting, based on the Central Excise data provided by the firm, decided to ratify norms under Para 4.7 of HBP v 1 as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed 2Amino 5Chloro Benzamide (ACBAM) 1 kg 1 2 3 Isatoic Anhydride Sulfolane Ammonium Carbonate 1.51 kg 1.30 1.07 RA may take appropriate action as per the decision of Norms Committee
14
Case No.:9/24/82ALC4/2010
Party Name:RAMPEX LABS PVT. LTD. 31.01.2012 Status:Case Deferred HQ File :01/82/050/00809/AM11/ RLA File :09/24/040/00194/AM11/ Lic.No/Date:0910043391 07.09.2010 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 15
Case No.:43/31/82ALC4/2010
Party Name:MADHUKAR HORMONES & STERODIS [P] LTD. 31.01.2012 Status:Case Deferred HQ File :01/82/050/00968/AM11/ RLA File :03/95/040/00341/AM11/ Lic.No/Date:0310593360 22.09.2010 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to remind the firm to furnish consumption and production data duly certified by Central Excise Authority. Accordingly, the case has been deferred for 28.2.2012. 16
Case No.:20/39/82ALC4/2010
Party Name:MADHUKAR HORMONES & STERODIS [P] LTD. 31.01.2012 Status:Case Deferred HQ File :01/82/050/01101/AM11/ RLA File :03/95/040/00321/AM11/ Lic.No/Date:0310593366 22.09.2010 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to remind the firm to furnish consumption and production data duly certified by Central Excise Authority. Accordingly, the case has been deferred for 28.2.2012. 17
Case No.:5/28/82ALC4/2010
Party Name:ANUS LABORATORIES LTD., 31.01.2012 Status:Case Deferred HQ File :01/82/050/00887/AM11/ RLA File :09/24/040/00137/AM11/ Lic.No/Date:0910043673 28.09.2010 Defer Date:28.02.2012 Decision : the Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting, decided to remind the firm to furnish the following information: Stepwise chemical reaction showing Mol. Weight of each reactant and output product. % yield on molar basis for each step. Material balance for entire process. Requirement and recovery of solvents of each step of manufacturing process. End use of the export product. Accordingly, the case has been deferred for 28.2.2012.
18
Case No.:10/28/82ALC4/2010
Party Name:VIVIMED LABS LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/00892/AM11/ RLA File :09/24/040/00273/AM11/ Lic.No/Date:0910043757 30.09.2010 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 19
Case No.:6/30/82ALC4/2010
Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/00925/AM11/ RLA File :03/94/040/00472/AM11/ Lic.No/Date:0310595543 06.10.2010 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to remind the firm to furnish the following technical details: Stepswise chemical reaction showing Mol. Wt. of each input and output product. % yield on molar basis for each step. Certificate of Analysis for Benzil (Tech.) from the foreign supplier. Copy of technical literature in support of yield claimed. Production –consumption data duly certified by Central Excise Authority. Accordingly the case has been deferred for 28.2.2012. 20
Case No.:124/40/82ALC4/2010
Party Name:SURYA PHARMACEUTICAL LTD 31.01.2012 Status:Case Deferred HQ File :01/82/050/01323/AM11/ RLA File :22/24/040/00049/AM11/ Lic.No/Date:2210010535 18.10.2010 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 21
Case No.:125/40/82ALC4/2010
Party Name:DSM ANTIINFECTIVES INDIA LTD Meet No/Date:44/82ALC4/2011 31.01.2012 Status:Case Deferred HQ File :01/82/050/01324/AM11/ RLA File :22/24/040/00055/AM11/ Lic.No/Date:2210010568 25.10.2010 Defer Date:28.02.2012 Decision :The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to remind the firm to furnish following information:
Technical details as per Appendix 33. Justification for the requirement of Enzyme 22
Case No.:53/40/82ALC4/2010
31.01.2012 Status:Case Approved HQ File :01/82/050/01252/AM11/ RLA File :09/24/040/00281/AM11/ Lic.No/Date:0910044023 26.10.2010 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in Meeting No. 27/82 dated 30.9.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed Tolmetin Sodium Dihydrate 1 Kg. 1. pToluoyl Chloride 0.958 kg 2. Toluene 3.10 kg 3. NHexane 1.94 kg 4. Methanol 2.43 kg 5. Dichloromethane 4.37 kg 6. Methyl1Methyl Pyrrole 2 Acetate 0.784 kg 7. Morpholine 0.54 kg RA concerned may take further necessary action as per above decision of NC. 23
Case No.:56/40/82ALC4/2010
31.01.2012 Status:Case Deferred HQ File :01/82/050/01255/AM11/ RLA File :09/24/040/00236/AM11/ Lic.No/Date:0910044022 26.10.2010 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to call from the firm production and consumption data duly certified by Central Excise Authority. Accordingly, the case has been deferred for 28.3.2012. 24
Case No.:8/32/82ALC4/2010
Party Name:SAURAV CHEMICALS LTD, 31.01.2012 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:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to
p g y p g 25
Case No.:12/32/82ALC4/2010
31.01.2012 Status:Case Approved HQ File :01/82/050/00994/AM11/ RLA File :09/24/040/00300/AM11/ Lic.No/Date:0910044098 02.11.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/05/2011PI(Norms)I dated 28.11.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed Sitagliptin Phsophate 1 Kg 1 2 3 4 (Z)methyl3amino4(2,4,5 trifluorophenyl) but2enoate 3(Trifluoromethyl)5,6,7,8tetrahydro [1,2,4]triazolo[4,3a]pyrazine hydrochloride Tetrahydrofuran Methanol 7.00 1.82 10.33 14.67 26
Case No.:44/40/82ALC4/2010
Party Name:LUPIN LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/01243/AM11/ RLA File :03/95/040/00638/AM11/ Lic.No/Date:0310600874 11.11.2010 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 27
Case No.:3/35/82ALC4/2010
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 31.01.2012 Status:Case Deferred HQ File :01/82/050/01019/AM11/ RLA File :04/24/040/00215/AM11/ Lic.No/Date:0410118914 16.11.2010 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in light of written comments of Department of Pharmaceuticals forwarded vide their OM No. 45011/217/2010PI(Norms) dated 12.9.2011 decided to call from the firm proper DML for the export product from the firm.
28
Case No.:59/40/82ALC4/2010
Party Name:MEDCHL CHEMICALS AND PHARMACEUTICALS PVT LTD 31.01.2012 Status:Case Approved HQ File :01/82/050/01258/AM11/ RLA File :09/24/040/00324/AM11/ Lic.No/Date:0910044428 24.11.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/157/2011PI(Norms)I dated 3.1.2012 and in consultation with technical authority present in meeting, decided to ratify norms Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg D2 Aminobutanol 1 kg 1 2 3 DL2 Aminobutanol Monosodium Glutamate Toluene 2.2642 0.647 0.60 29
Case No.:25/40/82ALC4/2010
31.01.2012 Status:Case Deferred HQ File :01/82/050/01224/AM11/ RLA File :09/24/040/00238/AM11/ Lic.No/Date:0910044429 25.11.2010 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 30
Case No.:28/46/82ALC4/2010
31.01.2012 Status:Case Deferred HQ File :01/82/050/01583/AM11/ RLA File :09/24/040/00295/AM11/ Lic.No/Date:0910044520 01.12.2010 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 31
Case No.:13/7/82ALC4/2011
Party Name:GRANULES INDIA LIMITED 31.01.2012 Status:Case Approved HQ File :01/82/050/00179/AM12/ RLA File :09/24/040/00385/AM11/ Lic.No/Date:0910044627 10.12.2010 Defer Date:
Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/118/2011PI(Norms)I dated 3.1.2012 and in consultation with technical authority present in meeting, decided to ratify norms Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg Naproxen Sodium granules DC Grade 80% (Compresso NAP 80S) 1 kg 1 2 3 4 5 6 Naproxen Sodium Starch Sodium Starch Glycollate Silica Colloidal Anhydrous Povidone K30 Stearic Acid 0.800 0.140 0.030 0.015 0.005 0.010 32
Case No.:23/4/82ALC4/2011
Party Name:PADMINI AROMATICS PVT. LTD 31.01.2012 Status:Case Rejected HQ File :01/82/050/00074/AM12/ RLA File :07/24/040/00352/AM11/ Lic.No/Date:0710075977 13.12.2010 Defer Date: Decision : The committee considered the case as per agenda in consultation with the technical authorities present in the meeting and decided to close the case as the firm has not furnished Production and Consumption data duly certified by Central Excise Data. 33
Case No.:11/40/82ALC4/2010
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 31.01.2012 Status:Case Approved HQ File :01/82/050/01210/AM11/ RLA File :05/23/040/00250/AM11/ Lic.No/Date:0510279466 15.12.2010 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting, on the basis of comparative data available with the committee of other firms, decided to ratify norms under Para 4.7 of HBP v 1 as per details below, or as applied by the firm, whichever is lower Export product Export Qty. Sl.No. Import items Qty. allowed mg/tablet Pantoprazole 1No 1 Pantoprazole Sodium Monohydrate 22.53
p Tablet 2 3 4 p y Mannitol USP (Pearlitol 25 C) Sucrose USNF Hypromellose (Pharmacoat 6033 cps) USP 42.44 8.00 1.86 Pantoprazole Tablets 40 mg 1 no 1 2 3 4 Pantoprazole Sodium Mannitol USP (Pearlitol 25 C) Sucrose USNF Hypromellose (Pharmacoat 6033 cps) USP 45.06 84.88 16.00 3.72 RA may take appropriate action as per the decisionof Norms Committee. 34
Case No.:5/41/82ALC4/2010
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 31.01.2012 Status:Case Deferred HQ File :01/82/050/01353/AM11/ RLA File :09/24/040/00415/AM11/ Lic.No/Date:0910044855 22.12.2010 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to call the representative of the firm for personal hearing on 28.2.2012. 35
Case No.:30/41/82ALC4/2010
31.01.2012 Status:Case Deferred HQ File :01/82/050/01378/AM11/ RLA File :05/23/040/00270/AM11/ Lic.No/Date:0510280724 30.12.2010 Defer Date:28.02.2012 Decision : Committee decided to remind the firm to furnish end use of the export product . Accordingly, the case has been deferred for 28.2.2012. 36
Case No.:1/42/82ALC4/2010
Party Name:SHAMROCK PHARMACHEMI PRIVATE LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/01448/AM11/ RLA File :03/95/040/00825/AM11/ Lic.No/Date:0310609520 05.01.2011 Defer Date:28.02.2012 Decision : Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting, decided to call from the firm complete technical details as per Appendix 33. Accordingly, the case has been deferred for 28.2.2012.
37
Case No.:14/51/82ALC4/2010
Party Name:TITAN LABORATORIES PVT. LTD. 31.01.2012 Status:Case Deferred HQ File :01/82/050/01731/AM11/ RLA File :03/95/040/00694/AM11/ Lic.No/Date:0310609837 06.01.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in the light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/27/2011PI (Norms) dated 28.11.2012 decided to call from the firm the following details: Copy of valid Drug Manufacturing License Copy of Master Batch Formula duly certified by Quality Control Incharge. 38
Case No.:4/44/82ALC4/2010
Party Name:VIJAYASRI ORGANICS LTD 31.01.2012 Status:Case Approved HQ File :01/82/050/01503/AM11/ RLA File :09/71/040/00083/AM11/ Lic.No/Date:0910045205 19.01.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/110/2011PI(Norms)I dated 6.1.2012 and in consultation with technical authority present in meeting, decided to ratify norms Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg 4Fluoroa2 Methyl1 Oxopropyl)g OxoNB Diphenyl Benzene Butaneamide (Diketone, Intermediate for Atorvastatin) 1 kg 1 2 3 Flurobenzene Methylene Dichloride (MDC) Methyl Iso Butyryl Acetate (MIBA) 0.47 2.87 0.706 39
Case No.:7/44/82ALC4/2010
Party Name:SAIRAM ORGANICS PVT. LTD., 31.01.2012 Status:Case Approved HQ File :01/82/050/01506/AM11/ RLA File :09/24/040/00488/AM11/ Lic.No/Date:0910045214 20.01.2011 Defer Date:
Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/103/2011PI(Norms)I dated 3.1.2012 and in consultation with technical authority present in meeting, decided to ratify norms Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg Flavoxate HCL 1 kg 1 3Methyl Flavone8Carboxylic Acid 0.883 40
Case No.:23/6/82ALC4/2011
31.01.2012 Status:Case Deferred HQ File :01/82/050/00141/AM12/ RLA File :09/24/040/00484/AM11/ Lic.No/Date:0910045232 27.01.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 41
Case No.:31/47/82ALC4/2010
31.01.2012 Status:Case Deferred HQ File :01/82/050/01621/AM11/ RLA File :09/24/040/00510/AM11/ Lic.No/Date:0910045498 09.02.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 42
Case No.:36/47/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/01626/AM11/ RLA File :09/24/040/00509/AM11/ Lic.No/Date:0910045516 11.02.2011 Defer Date:28.02.2012 Decision : Committee considered the case as per agenda and in consultation with technical authorities observed that the firm has submitted two applications with different inputs. Committee decided to call the firm for personal hearing on 28.2.2012 and also to furnish Past production visàvis actual consumption data duly certified by Central Excise Authorities. 43
Case No.:53/47/82ALC4/2010
Party Name:NEULAND LABORATORIES LTD 31.01.2012 Status:Case Deferred HQ File :01/82/050/01643/AM11/ RLA File :09/24/040/00519/AM11/ Lic.No/Date:0910045550 14.02.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to
44
Case No.:7/48/82ALC4/2010
Party Name:ALKYL AMINES CHEMICALS LTD 31.01.2012 Status:Case Approved HQ File :01/82/050/01650/AM11/ RLA File :03/94/040/00121/AM10/ Lic.No/Date:0310615984 14.02.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Chemicals and Petrochemicals vide their UO No. 14010/27/2009Ch. II dated 31.1.2012 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg TRIS2ETHYL HEXYLAMINE 1 kg 1 2 2 Ethyl Hexanal 2 Ethyl Hexylamine 0.805 kg 0.405 kg 45
Case No.:11/8/82ALC4/2011
31.01.2012 Status:Case Approved HQ File :01/82/050/00211/AM12/ RLA File :09/24/040/00499/AM11/ Lic.No/Date:0910045601 18.02.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their UO No. 35011/136/2011PI (Norms) dated 3.1.2012 and in consultation with technical authority present in meeting, decided to ratify norms Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg Valganciclovir Hydrochloride 1 kg 1 2 3 4 5 6 ZValine NCA Dimethyl Formamide Methylene Dichloride Methanol Isopropyl Alcohol CecaCarbon 2.72 6.476 16.190 24.286 8.095 0.100
7 8 Cyclohexane Acetone 8.095 8.095 46
Case No.:27/3/82ALC4/2011
Party Name:IPCA LABORATORIES LIMITED 31.01.2012 Status:Case Approved HQ File :01/82/050/00027/AM12/ RLA File :03/94/040/01009/AM11/ Lic.No/Date:0310616955 21.02.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their UO No. 35011/68/2011PI (Norms) dated 8.12.2011 and in consultation with technical authority present in meeting, decided to ratify norms Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg Methyl Testosterone 1 kg 1 4Androstene3,17Dione 1.00 47
Case No.:43/51/82ALC4/2010
Party Name:MEDCHL CHEMICALS AND PHARMACEUTICALS PVT LTD 31.01.2012 Status:Case Approved HQ File :01/82/050/01760/AM11/ RLA File :09/24/040/00539/AM11/ Lic.No/Date:0910045802 04.03.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/157/2011PI(Norms)I dated 3.1.2012 and in consultation with technical authority present in meeting, decided to ratify norms Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg D2 Aminobutanol 1 kg 1 2 3 DL2 Aminobutanol Monosodium Glutamate Toluene 2.2642 0.647 0.60
48
Case No.:5/4/82ALC4/2011
Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 31.01.2012 Status:Case Deferred HQ File :01/82/050/00056/AM12/ RLA File :03/95/040/00949/AM11/ Lic.No/Date:0310620143 08.03.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 49
Case No.:29/8/82ALC4/2011
Party Name:IPCA LABORATORIES LIMITED 31.01.2012 Status:Case Approved HQ File :01/82/050/00229/AM12/ RLA File :03/94/040/01012/AM11/ Lic.No/Date:0310620022 08.03.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/124/2011PI(Norms)I dated 3.1.2012 and in consultation with technical authority present in meeting, decided to ratify norms Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg Testosterone Isocaproate 1 kg 1 4Androstene3,17Dione 1.00 50
Case No.:16/10/82ALC4/2011
Party Name:VASUDHA PHARMA CHEM LTD 31.01.2012 Status:Case Approved HQ File :01/82/050/00275/AM12/ RLA File :09/24/040/00327/AM11/ Lic.No/Date:0910045893 11.03.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/226/2011PI(Norms)I dated 3.1.2012 and in consultation with technical authority present in meeting, decided to ratify norms Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg Donepezil HCL 1 kg 1 2 3 4 5,6Dimethoxy Indanone Pyridine4Aldehyde Toluene Chloroform 1.423 0.957 3.75 3.125
5 6 7 Methanol Methyl Iso Butyl Ketone Methylene Di Chloride 5.667 2.183 2.50 51
Case No.:29/6/82ALC4/2011
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 31.01.2012 Status:Case Approved HQ File :01/82/050/00147/AM12/ RLA File :03/94/040/01046/AM11/ Lic.No/Date:0310621245 15.03.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/287/2011PI(Norms)I dated 4.1.2012 and in consultation with technical authority present in meeting, decided to ratify norms Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg 2(N.N Dimethylamino)2 Phenyl1Butanol 1 kg 1 2 3 4 5 6 7 Propiophenone Methanol Sodium Cyanide Caustic Soda Flakes Dimethyl Sulphate Fomaldehyde Synhydride/Vitride 2.10 2.88 0.768 1.00 1.019 0.66 2.412 52
Case No.:17/10/82ALC4/2011
31.01.2012 Status:Case Deferred HQ File :01/82/050/00276/AM12/ RLA File :09/24/040/00521/AM11/ Lic.No/Date:0910045939 16.03.2011 Defer Date:28.02.2012
Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 53
Case No.:21/10/82ALC4/2011
31.01.2012 Status:Case Approved HQ File :01/82/050/00280/AM12/ RLA File :09/24/040/00500/AM11/ Lic.No/Date:0910045938 16.03.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/273/2011PI(Norms)I dated 4.1.2012 and in consultation with technical authority present in meeting, decided to ratify norms Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg Valsartan 1 kg 1 2 3 4 5 Methyl N(2Cyanobiphenyl4yl) methyl) LValinate HydrochlorideCMVEH Valeryl Chloride Tri Ethyl Amine Iso Propyl Ether Methylene Dichloride 1.525 0.82 1.45 3.02 14.95 54
Case No.:5/2/82ALC4/2011
Party Name:SMRUTHI ORGANICS LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/01795/AM11/ RLA File :31/24/040/00281/AM11/ Lic.No/Date:3110047488 22.03.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 55
Case No.:11/2/82ALC4/2011
Party Name:NIFTY LABS PVT LTD., 31.01.2012 Status:Case Approved
HQ File :01/82/050/01801/AM11/ RLA File :09/24/040/00588/AM11/ Lic.No/Date:0910046079 25.03.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/172/2011PI(Norms)I dated 4.1.2012 and in consultation with technical authority present in meeting, decided to ratify norms Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg Rabeprazole 1 kg 1 2 3 4 5 6 7 2,3Lutidine Methanol Iso Propyl Alcohol Toluene 3Methoxy1Propanol Acetone Methylene Chloride 1.344 0.337 0.961 0.641 1.30 0.961 1.30 56
Case No.:12/2/82ALC4/2011
Party Name:NIFTY LABS PVT LTD., 31.01.2012 Status:Case Deferred HQ File :01/82/050/01802/AM11/ RLA File :09/24/040/00589/AM11/ Lic.No/Date:0910046080 25.03.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 57
Case No.:13/2/82ALC4/2011
Party Name:NIFTY LABS PVT LTD., 31.01.2012 Status:Case Approved HQ File :01/82/050/01803/AM11/ RLA File :09/24/040/00590/AM11/ Lic.No/Date:0910046081 25.03.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/176/2011PI(Norms)I dated 3.1.2012 and in consultation with technical authority present in meeting, decided to ratify norms Export product Export Qty. Sl.No. Import items Qty. allowed
kg/kg Dibenzo [b,f] [1,4] thiazepin 11(10 H)one 1 kg 1 2 3 4 Thiophenol Phenyl Chloro Formate Hydrasien Hydrate 80% Poly Phosphoric Acid 84% 0.68 1.062 0.793 5.10 58
Case No.:14/2/82ALC4/2011
Party Name:NIFTY LABS PVT LTD., 31.01.2012 Status:Case Approved HQ File :01/82/050/01804/AM11/ RLA File :09/24/040/00591/AM11/ Lic.No/Date:0910046082 25.03.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/179/2011PI(Norms)I dated 3.1.2012 and in consultation with technical authority present in meeting, decided to ratify norms Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg N[dibenzo[b,f] [1,4] thiazepin 11YL] Piperazine Hydrochloride 1 kg 1 2 3 4 5 6 Thiophenol Hydrazien Hydrate 80% Acetone Poly Phosphoric Acid 84% Piperzine Anhydrous Iso Propyl Alcohol 0.68 0.793 0.661 5.10 1.41 0.938 59
Case No.:15/2/82ALC4/2011
Party Name:VIJETA LIFE SCIENCES PVT LTD., 31.01.2012 Status:Case Approved HQ File :01/82/050/01805/AM11/ RLA File :09/24/040/00571/AM11/ Lic.No/Date:0910046087 25.03.2011 Defer Date:
Decision : : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/237/2011PI(Norms)I dated 3.1.2012 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg Adenine 1 kg 1 Hypoxanthine 1.33 60
Case No.:30/8/82ALC4/2011
Party Name:KOPRAN LIMITED 31.01.2012 Status:Case Approved HQ File :01/82/050/00230/AM12/ RLA File :03/94/040/01136/AM11/ Lic.No/Date:0310623342 25.03.2011 Defer Date: Decision : : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/121/2011PI(Norms)I dated 3.1.2012 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg Meropenem for Injection USP 1 kg 1 Meropenem Trihydrate NonSterile 1.032 61
Case No.:37/6/82ALC4/2011
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 31.01.2012 Status:Case Deferred HQ File :01/82/050/00155/AM12/ RLA File :05/24/040/00437/AM11/ Lic.No/Date:0510286990 28.03.2011 Defer Date:28.02.2012 Decision : Committee decided to remind the firm to furnish complete chemical name of the export product. Accordingly, the case has been deferred for 28.02.2012. 62
Case No.:15/19/82ALC4/2011
Party Name:HETERO LABS LIMITED 31.01.2012 Status:Case Approved HQ File :01/82/050/00529/AM12/ RLA File :09/24/040/00597/AM11/ Lic.No/Date:0910046128 29.03.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting, on the basis of comparative data available, decided to ratify norms under Para 4.7 of HBP v1 as per details below or as applied by firm whichever is
lower: Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg Bicalutamide 1 kg 1 2 3 4 2,3EPOXY2METHYLN[4CYANO3 (TRIFLUOROMETHYL)PHENYL]PROPANAMIDE PFLUORO THIO PHENOL DIISOPROPYL ETHER METHYLENE CHLORIDE 1.11 0.50 0.925 2.062 63
Case No.:41/14/82ALC4/2011
31.01.2012 Status:Case Deferred HQ File :01/82/050/00432/AM12/ RLA File :09/24/040/00609/AM11/ Lic.No/Date:0910046267 05.04.2011 Defer Date:28.02.2012 Decision : Committee decided to remind the firm to furnish complete chemical name of the export product. Accordingly, the case has been deferred for 28.02.2012. 64
Case No.:18/4/82ALC4/2011
31.01.2012 Status:Case Approved HQ File :01/82/050/00069/AM12/ RLA File :05/23/040/00380/AM11/ Lic.No/Date:0510287716 07.04.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in Meeting No. 35/82 held on 29.11.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed 2,3Difluro5 Chloro Pyridine 1 kg. 1. Potassium Fluoride 1.180 kg 2. Sulpholane 0.320 kg 3. Toluene 0.318 kg 4. Tetraglyme 0.023 kg 5. Denatured Ethyl Alcohol 3.776 kg 6. Methanol 2.270 kg 7. Alumino Silicate Catalyst 0.0310 kg 8. Toluene 0.199 kg
Sodium Nitrite 0.894 kg 10. Thionyl Chloride 1.517 kg 11. DMF (Di Methyl Formamide) 0.553 kg 12. Stergene 0.002 kg 13. Caustic 3.160 kg RA concerned may take further necessary action as per above decision of NC. 65
Case No.:19/4/82ALC4/2011
31.01.2012 Status:Case Deferred HQ File :01/82/050/00070/AM12/ RLA File :05/23/040/00381/AM11/ Lic.No/Date:0510287719 07.04.2011 Defer Date:28.02.2012 Decision : Committee decided to remind the firm to furnish following information: 1. Details of manufacturing process with chemical equations, molecular formula and molecular weight. 2. Yields obtained in each step. 3. Printed technical literature in support of yield obtained in each step supported with authentic technical literature and norms claimed. 4. CA certificate regarding past three years production and corresponding consumption of different raw materials. 5. Central Excise data. 66
Case No.:32/8/82ALC4/2011
Party Name:ENCUBE ETHICALS PVT LTD 31.01.2012 Status:Case Deferred HQ File :01/82/050/00232/AM12/ RLA File :03/94/040/01167/AM11/ Lic.No/Date:0310625603 07.04.2011 Defer Date:28.02.2012 Decision : Committee considered the case as per agenda and in consultation with the technical authorities present in the case decided to call from the firm Drug Manufacturing License and also Master Batch Formula. Accordingly, the case has been deferred for 28.2.2012. 67
Case No.:41/8/82ALC4/2011
Party Name:ENCUBE ETHICALS PVT LTD 31.01.2012 Status:Case Deferred HQ File :01/82/050/00241/AM12/ RLA File :03/94/040/01171/AM11/ Lic.No/Date:0310625608 07.04.2011 Defer Date:28.02.2012 Decision : : Committee considered the case as per agenda and in consultation with the technical authorities present in the case decided to call from the firm Drug Manufacturing License and also Master Batch Formula. Accordingly, the case has been deferred for 28.2.2012. 68
Case No.:48/4/82ALC4/2011
31.01.2012 Status:Case Deferred Lic.No/Date:0910046368
HQ File :01/82/050/00099/AM12/ RLA File :09/24/040/00003/AM12/ 12.04.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 69
Case No.:6/5/82ALC4/2011
31.01.2012 Status:Case Deferred HQ File :01/82/050/00108/AM12/ RLA File :09/24/040/00004/AM12/ Lic.No/Date:0910046405 18.04.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 70
Case No.:16/12/82ALC4/2011
Party Name:ENCUBE ETHICALS PVT LTD 31.01.2012 Status:Case Deferred HQ File :01/82/050/00349/AM12/ RLA File :03/94/040/00042/AM12/ Lic.No/Date:0310627685 21.04.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 71
Case No.:15/12/82ALC4/2011
Party Name:ENCUBE ETHICALS PVT LTD 31.01.2012 Status:Case Deferred HQ File :01/82/050/00348/AM12/ RLA File :03/94/040/00052/AM12/ Lic.No/Date:0310627904 25.04.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 72
Case No.:32/14/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/00423/AM12/ RLA File :09/24/040/00605/AM11/ Lic.No/Date:0910046500 26.04.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 73
Case No.:44/6/82ALC4/2011
Party Name:SUVEN LIFE SCIENCES LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/00163/AM12/ RLA File :09/24/040/00038/AM12/ Lic.No/Date:0910046559 28.04.2011 Defer Date:28.02.2012
Decision : The Committee decided to call from the firm production and consumption data duly certified by Central Excise Authority. 74
Case No.:47/6/82ALC4/2011
Party Name:JOCIL LTD., 31.01.2012 Status:Case Deferred HQ File :01/82/050/00166/AM12/ RLA File :09/24/040/00051/AM12/ Lic.No/Date:0910046581 29.04.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 75
Case No.:4/8/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/00204/AM12/ RLA File :09/24/040/00606/AM11/ Lic.No/Date:0910046587 02.05.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 76
Case No.:6/8/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/00206/AM12/ RLA File :09/24/040/00032/AM12/ Lic.No/Date:0910046590 02.05.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 77
Case No.:8/8/82ALC4/2011
Party Name:MAITHRI LABORATORIES (P) LTD., Meet No/Date:44/82ALC4/2011 31.01.2012 Status:Case Deferred HQ File :01/82/050/00208/AM12/ RLA File :09/24/040/00015/AM12/ Lic.No/Date:0910046598 03.05.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 78
Case No.:18/16/82ALC4/2011
Party Name:MATRIX LABORATORIES LIMITED Meet No/Date:44/82ALC4/2011 31.01.2012 Status:Case Approved HQ File :01/82/050/00476/AM12/ RLA File :09/24/040/00011/AM12/ Lic.No/Date:0910046614 03.05.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their UO No. 35011/136/2011PI (Norms) dated 3.1.2012 and in consultation with technical authority present in meeting, decided to ratify norms
Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg Valganciclovir Hydrochloride 1 kg 1 2 3 4 5 6 7 8 ZValine NCA Dimethyl Formamide Methylene Dichloride Methanol Isopropyl Alcohol CecaCarbon Cyclohexane Acetone 2.72 6.476 16.190 24.286 8.095 0.100 8.095 8.095 RA may take appropriate action as per the decision of NC. 79
Case No.:3/8/82ALC4/2011
Party Name:NAPROD LIFE SCIENCES PVT. LTD. Meet No/Date:44/82ALC4/2011 31.01.2012 Status:Case Approved HQ File :01/82/050/00203/AM12/ RLA File :03/95/040/00084/AM12/ Lic.No/Date:0310629782 05.05.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their UO No. 35011/165/2011PI (Norms) dated 3.1.2012 and in consultation with technical authority present in meeting, decided to ratify norms Export product Export Qty. Sl.No. Import items Qty. allowed Asparaginase for injection 1 kg 1 Asparaginase 10,500IU/VIAL RA may take appropriate action as per the decision of NC. 80
Case No.:9/14/82ALC4/2011
Party Name:IPCA LABORATORIES LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/00400/AM12/ RLA File :03/94/040/00091/AM12/ Lic.No/Date:0310629729 05.05.2011 Defer Date:28.02.2012
Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 81
Case No.:2/8/82ALC4/2011
Party Name:EMBIO LTD 31.01.2012 Status:Case Deferred HQ File :01/82/050/00202/AM12/ RLA File :03/94/040/01025/AM11/ Lic.No/Date:0310629987 06.05.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per the agenda and in the light of written comments from Department of Pharmaceuticals vide their OM No. 35011/279/2011PI(Norms) dated 23.12.2011 and in consultation with technical authority it has been decided to call from the firm the following technical details: Stepwise complete and balanced chemical reaction showing mol. Wt. of all inputs and output production and their molar requirements. % yield on molar basis for each step and its justification. Materail balance for entire process. Detailed working with technical justification for utilizing 36.0 kg molasses per kg export product. Requirement & Recovery of solvent at each step. The Committee decided to call the firm for Personal Hearing on 7.2.2012. 82
Case No.:19/8/82ALC4/2011
Party Name:RA CHEM PHARMA LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/00219/AM12/ RLA File :09/24/040/00071/AM12/ Lic.No/Date:0910046667 06.05.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to call from the firm production and consumption data duly certified by Central Excise Authority. Accordingly, the case has been deferred for 28.2.2012. 83
Case No.:15/16/82ALC4/2011
Party Name:RA CHEM PHARMA LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/00473/AM12/ RLA File :09/24/040/00035/AM12/ Lic.No/Date:0910046677 09.05.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to call from the firm production and consumption data duly certified by Central Excise Authority. Accordingly, the case has been deferred for 28.2.2012. 84
Case No.:42/8/82ALC4/2011
Party Name:FRESENIUS KABI ONCOLOGY LIMITED 31.01.2012 Status:Case Approved
HQ File :01/82/050/00242/AM12/ RLA File :05/23/040/00366/AM11/ Lic.No/Date:0510290205 10.05.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their UO No. 35011/288/2011PI (Norms) dated 3.1.2012 and in consultation with technical authority present in meeting, decided to ratify norms Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg Pacitaxel 1 kg 1 2 3 4 (4S,5R)2(4Methoxy Phenyl)NBenzoyl 4PhenylOxazolidine5Carboxylic Acid Silica Gel 60 4Dimethyl Amino Pyridine 10Deacetyl BaccatinIII 1.12 20.00 0.100 1.50 RA may take appropriate action as per the decision of Norms Committee. 85
Case No.:5/12/82ALC4/2011
Party Name:LUPIN LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/00338/AM12/ RLA File :03/95/040/00067/AM12/ Lic.No/Date:0310630428 10.05.2011 Defer Date: 28.2.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to . 86
Case No.:45/8/82ALC4/2011
31.01.2012 Status:Case Deferred HQ File :01/82/050/00245/AM12/ RLA File :09/24/040/00078/AM12/ Lic.No/Date:0910046700 11.05.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 87
Case No.:31/14/82ALC4/2011
31.01.2012 Status:Case Approved
HQ File :01/82/050/00422/AM12/ RLA File :09/24/040/00023/AM12/ Lic.No/Date:0910046786 19.05.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/273/2011PI(Norms)I dated 4.1.2012 and in consultation with technical authority present in meeting, decided to ratify norms Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg Valsartan 1 kg 1 2 3 4 5 6 Methyl N(2Cyanobiphenyl4yl) methyl) LValinate HydrochlorideCMVEH Valeryl Chloride Tri Ethyl Amine Iso Propyl Ether Methylene Dichloride Tributyl in Chloride 1.525 0.82 1.45 3.02 14.95 3.80 88
Case No.:5/10/82ALC4/2011
Party Name:HETERO LABS LIMITED 31.01.2012 Status:Case Approved HQ File :01/82/050/00264/AM12/ RLA File :09/24/040/00087/AM12/ Lic.No/Date:0910046811 20.05.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting, on the basis of comparative data available, decided to decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg Abacavir Sulphate 1 kg 1 2 Vincelactam Di.tert.butyl.dicarbonate 2.50 5.00
3 4 5 6 7 8 9 10 11 Dimethyl formamide Sodium borohydride nHexane D() Tartaric Acid N(2Amino4,6Dichloropyridin5yl) formamide Triethyl ortho formate Tetrahydrofuran Methanol Cyclopropylamine 7.00 0.946 4.98 1.45 1.042 1.50 4.15 1.52 0.19 RA may take appropriate action as per the decision of NC. 89
Case No.:33/10/82ALC4/2011
31.01.2012 Status:Case Deferred HQ File :01/82/050/00292/AM12/ RLA File :05/23/040/00045/AM12/ Lic.No/Date:0510291486 24.05.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 90
Case No.:35/10/82ALC4/2011
31.01.2012 Status:Case Deferred HQ File :01/82/050/00294/AM12/ RLA File :05/23/040/00048/AM12/ Lic.No/Date:0510291488 24.05.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 91
Case No.:43/10/82ALC4/2011
Party Name:DR REDDYS LABORATORIES LTD 31.01.2012 Status:Case Deferred HQ File :01/82/050/00302/AM12/ RLA File :09/24/040/00093/AM12/ Lic.No/Date:0910046918 26.05.2011 Defer
Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 92
Case No.:41/10/82ALC4/2011
Party Name:HETERO LABS LIMITED 31.01.2012 Status:Case Approved HQ File :01/82/050/00300/AM12/ RLA File :09/24/040/00111/AM12/ Lic.No/Date:0910046916 26.05.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting, on the basis of comparative data available, decided to decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg 3,5 Bis(methane sulfonyl)2,2 anhydro5 methyl uridine 1 kg 1 2 3 4 5Methyl Uridine NMethyl morpholine Methane Sulfonyl Chloride Acetone 0.814 0.386 0.752 1.10 93
Case No.:51/10/82ALC4/2011
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 31.01.2012 Status:Case Deferred HQ File :01/82/050/00310/AM12/ RLA File :09/24/040/00095/AM12/ Lic.No/Date:0910046934 27.05.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in the light of written comments of Department of Pharmaceuticals forwarded vide OM No. 35011/42/2011PI (Norms) dated 8.12.2011 decided to call from the firm the following details: Stepwise complete and balanced chemical reaction showing Mol. Wt. of each input & output and molar requirement of each reactant. %yield on molar basis for each step. Requirement & Recovery of solvent at each step of manufacturing process. 94
Case No.:1/14/82ALC4/2011
Party Name:STERLING AUXILIARIES PVT LTD Status:Case
31.01.2012 Deferred HQ File :01/82/050/00392/AM12/ RLA File :03/95/040/00138/AM12/ Lic.No/Date:0310633159 27.05.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 95
Case No.:55/10/82ALC4/2011
Party Name:GRANULES INDIA LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/00314/AM12/ RLA File :09/24/040/00108/AM12/ Lic.No/Date:0910046940 27.05.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 96
Case No.:44/14/82ALC4/2011
Party Name:ONEIRO CHEMICALS LTD 31.01.2012 Status:Case Deferred HQ File :01/82/050/00435/AM12/ RLA File :34/24/040/00037/AM12/ Lic.No/Date:3410030415 30.05.2011 Defer Date: 28.02.2012 Decision : Committee considered case as per agenda and decided to defer the case for comments of Departmentof Pharmaceuticals for 28.2.2012. 97
Case No.:2/15/82ALC4/2011
Party Name:ACHARYA CHEMICALS 31.01.2012 Status:Case Deferred HQ File :01/82/050/00442/AM12/ RLA File :03/94/040/00130/AM12/ Lic.No/Date:0310633824 31.05.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 98
Case No.:14/11/82ALC4/2011
Party Name:HETERO DRUGS LIMITED, 31.01.2012 Status:Case Approved HQ File :01/82/050/00328/AM12/ RLA File :09/24/040/00106/AM12/ Lic.No/Date:0910046965 01.06.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in Meeting No. 50/82 dated 15.3.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower:
Export product Export Qty. Sl.No. Import items Qty. allowed Indinavir Sulphate 1kg. 1. {3aS[3s*(R*)]3a alphe,8a alpha} (3,3a,8,8a)tetrahydro2,2dimethyl3(2 oxyranylmethyl)1oxo3phenyl propyl)2Hindino(1,2d)oxazole 0.754 kg 2. 2Cyano Pyrazine 0.839 kg 3. Tert. Butanol 2.00 kg 4. Triethyl Amine 1.106 kg 5. Methylene Chloride 5.94 kg 6. Ditert. Butyl dicarbonate (DIBOC) 0.489 kg 7. nHexane 1.90 kg 8. Isopropyl Acetate 3.00 kg 9. 3Chloromethyl Pyridine Hcl 0.5322 kg 10. Dimethyl Formamide 2.05 kg RA concerned may take further necessary action as per above decision of Norms 99
Case No.:5/15/82ALC4/2011
Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/00445/AM12/ RLA File :03/94/040/00139/AM12/ Lic.No/Date:0310634097 01.06.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 100
Case No.:19/11/82ALC4/2011
31.01.2012 Status:Case Deferred HQ File :01/82/050/00333/AM12/ RLA File :09/24/040/00079/AM12/ Lic.No/Date:0910046974 02.06.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 101 Case No.:38/12/82ALC4/2011 Party Name:SRINI PHARMACEUTICALS LTD., 31.01.2012 Status:Case Approved HQ File :01/82/050/00371/AM12/ RLA File :09/24/040/00113/AM12/ Lic.No/Date:0910046991 03.06.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No 35011/244/2011PI(Norms) dated 4.1.2012 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower:
Export product Export Qty. Sl.No. Import items Qty. allowed Mirtazapine 1 kg 1 24Methyl2PhenylPiperazin1YL) Nicotinic Acid 1.591 2 Sodium BIS(2Methoxyethoxy Aluminium Hydride (Vitride) 2.97 102
Case No.:27/19/82ALC4/2011
31.01.2012 Status:Case Deferred HQ File :01/82/050/00541/AM12/ RLA File :09/24/040/00086/AM12/ Lic.No/Date:0910046997 06.06.2011 Defer Date:28.02.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 103
Case No.:34/12/82ALC4/2011
Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/00367/AM12/ RLA File :03/94/040/01112/AM11/ Lic.No/Date:0310634571 06.06.2011 Defer Date:28.02.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 104
Case No.:6/18/82ALC4/2011
31.01.2012 Status:Case Deferred HQ File :01/82/050/00510/AM12/ RLA File :09/24/040/00094/AM12/ Lic.No/Date:0910047017 06.06.2011 Defer Date:28.02.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 105
Case No.:25/19/82ALC4/2011
31.01.2012 Status:Case Deferred HQ File :01/82/050/00539/AM12/ RLA File :09/24/040/00085/AM12/ Lic.No/Date:0910046996 06.06.2011 Defer Date:28.02.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 106 Case No.:10/19/82ALC4/2011 Party Name:AUROBINDO PHARMA LIMITED Status:Case
31.01.2012 Deferred HQ File :01/82/050/00524/AM12/ RLA File :09/24/040/00128/AM12/ Lic.No/Date:0910047036 07.06.2011 Defer Date:28.02.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 107
Case No.:27/16/82ALC4/2011
Party Name:ALEMBIC PHARMACEUTICALS LTD 31.01.2012 Status:Case Deferred HQ File :01/82/050/00485/AM12/ RLA File :34/24/040/00039/AM12/ Lic.No/Date:3410030563 10.06.2011 Defer Date:28.02.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 108
Case No.:34/19/82ALC4/2011
Party Name:COVALENT LABORATORIES PRIVATE LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/00548/AM12/ RLA File :09/24/040/00616/AM11/ Lic.No/Date:0910047091 10.06.2011 Defer Date:28.02.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 109
Case No.:4/16/82ALC4/2011
Party Name:BOSTIK INDIA PRIVATE LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/00462/AM12/ RLA File :07/24/040/00073/AM12/ Lic.No/Date:0710079777 13.06.2011 Defer Date:28.02.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 110
Case No.:21/19/82ALC4/2011
31.01.2012 Status:Case Deferred HQ File :01/82/050/00535/AM12/ RLA File :09/24/040/00138/AM12/ Lic.No/Date:0910047112 14.06.2011 Defer Date:28.02.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 111
Case No.:26/16/82ALC4/2011
Party Name:NECTAR LIFESCIENCES LIMITED, 31.01.2012 Status:Case Approved Lic.No/Date:2210011505
HQ File :01/82/050/00484/AM12/ RLA File :22/24/040/00018/AM12/ 14.06.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting , based on the comparison of data available, decided to ratify norms under Para 4.7 of HBP v 1 as per details below or as applied by the firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg Cefoperazone Sodium 1 kg 1 2 3 4 Cefoperazone Acid Sodium bicarbonate Activated Carbon Acetone 1.11 0.15 0.02 2.95 112
Case No.:12/19/82ALC4/2011
Party Name:BALAJI AMINES LIMITED 31.01.2012 Status:Case Approved HQ File :01/82/050/00526/AM12/ RLA File :31/83/040/00047/AM12/ Lic.No/Date:3110048658 15.06.2011 Defer Date: Decision : : Committee considered case as per agenda and in light of written comments of Department of Chemicals and Petrochemicals forwarded vide U.O No. 14010/122/Ch.II dated 23.12.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed NEthyl2 Pyrrolidone 1 kg 1 2 3 4 1.4 Butanediol Ammonia Anhydrous Ethyl Alcohol (95% Minimum) (denatured) Ethylamine Catalyst 0.882 kg 0.176 kg 0.512 kg 0.001 kg 113
Case No.:23/19/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 31.01.2012 Status:Case Deferred
HQ File :01/82/050/00537/AM12/ RLA File :09/24/040/00105/AM12/ Lic.No/Date:0910047123 15.06.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 114
Case No.:24/19/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/00538/AM12/ RLA File :09/24/040/00125/AM12/ Lic.No/Date:0910047121 15.06.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 115
Case No.:33/19/82ALC4/2011
31.01.2012 Status:Case Deferred HQ File :01/82/050/00547/AM12/ RLA File :09/24/040/00130/AM12/ Lic.No/Date:0910047113 15.06.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 116
Case No.:13/19/82ALC4/2011
Party Name:NIFTY LABS PVT LTD., 31.01.2012 Status:Case Deferred HQ File :01/82/050/00527/AM12/ RLA File :09/24/040/00148/AM12/ Lic.No/Date:0910047160 16.06.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 117
Case No.:32/19/82ALC4/2011
Party Name:MAITHRI LABORATORIES (P) LTD., Meet No/Date:44/82ALC4/2011 31.01.2012 Status:Case Deferred HQ File :01/82/050/00546/AM12/ RLA File :09/24/040/00139/AM12/ Lic.No/Date:0910047161 16.06.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 118
Case No.:5/19/82ALC4/2011
Party Name:CIPLA LIMITED 31.01.2012 Status:Case Approved HQ File :01/82/050/00519/AM12/ RLA File :03/94/040/00258/AM12/ Lic.No/Date:0310636879 17.06.2011 Defer Date:
Decision : Committee considered case as per agenda and based on comparison of data of the the past cases and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowedkg/kg Finasteride 1 kg 1 2 3 4 (3oxo4aza5AlphaAndrostane17 Beta1butyl Carboxamide)P7 Compound 1,4 Dioxane Dichloro Dicyano Benzoquinone (DDQ) BisTrimethyl Silyl trifluoro Acetamide (BSTFA) 1.7647 12.50 0.86 1.47 RA may take appropriate action as per the decision of NC. 119
Case No.:36/14/82ALC4/2011
Party Name:SHASUN PHARMACEUTICALS LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/00427/AM12/ RLA File :04/24/040/00069/AM12/ Lic.No/Date:0410125143 20.06.2011 Defer Date:28.02.2012 Decision : Committee considered the case as per agenda and in consultation with the technical authorities decided to remind the firm to furnish production and consumption data duly certified by Central Excise Authority. Accordingly, the case has been deferred for 28.2.2012 120
Case No.:17/19/82ALC4/2011
31.01.2012 Status:Case Deferred HQ File :01/82/050/00531/AM12/ RLA File :09/24/040/00137/AM12/ Lic.No/Date:0910047175 20.06.2011 Defer Date:28.02.2012 Decision : Committee considered the case as per agenda and in consultation with the technical authorities decided to remind the firm to furnish production and consumption data duly certified by Central Excise Authority. Accordingly, the case has been deferred for 28.2.2012 121
Case No.:23/21/82ALC4/2011
31.01.2012 Status:Case Deferred HQ File :01/82/050/00605/AM12/ RLA File :09/24/040/00129/AM12/ Lic.No/Date:0910047176 20.06.2011 Defer Date:28.02.2012 Decision : Committee considered the case as per agenda and in consultation with the technical authorities decided to remind the firm to furnish production and consumption data duly certified by Central Excise Authority. Accordingly, the case has been deferred for 28.2.2012
122
Case No.:46/14/82ALC4/2011
31.01.2012 Status:Case Deferred HQ File :01/82/050/00437/AM12/ RLA File :05/23/040/00105/AM12/ Lic.No/Date:0510294191 21.06.2011 Defer Date:28.02.2012 Decision : Committee considered the case as per agenda and in consultation with the technical authorities decided to remind the firm to furnish Master Batch Formula certified by Quality Control Incharge. Accordingly, the case has been deferred for 28.2.2012. 123
Case No.:47/14/82ALC4/2011
Party Name:FDC LTD 31.01.2012 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:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 124
Case No.:35/19/82ALC4/2011
Party Name:NECTAR LIFESCIENCES LIMITED, 31.01.2012 Status:Case Deferred HQ File :01/82/050/00549/AM12/ RLA File :22/24/040/00022/AM12/ Lic.No/Date:2210011532 28.06.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 125
Case No.:31/21/82ALC4/2011
Party Name:MATRIX LABORATORIES LIMITED Meet No/Date:44/82ALC4/2011 31.01.2012 Status:Case Deferred HQ File :01/82/050/00613/AM12/ RLA File :09/24/040/00143/AM12/ Lic.No/Date:0910047366 29.06.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 126
Case No.:25/21/82ALC4/2011
Party Name:MATRIX LABORATORIES LIMITED Meet No/Date:44/82ALC4/2011 31.01.2012 Status:Case Deferred HQ File :01/82/050/00607/AM12/ RLA File :09/24/040/00039/AM12/ Lic.No/Date:0910047386 30.06.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 127 Case No.:32/21/82ALC4/2011 Party Name:MATRIX LABORATORIES LIMITED Meet No/Date:44/82ALC4/2011 Status:Case
31.01.2012 Deferred HQ File :01/82/050/00614/AM12/ RLA File :09/24/040/00041/AM12/ Lic.No/Date:0910047385 30.06.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 128
Case No.:16/20/82ALC4/2011
Party Name:SAURAV CHEMICALS LTD, 31.01.2012 Status:Case Deferred HQ File :01/82/050/00578/AM12/ RLA File :22/24/040/00024/AM12/ Lic.No/Date:2210011568 01.07.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 129
Case No.:32/16/82ALC4/2011
Party Name:RANBAXY LABORATORIES LTD 31.01.2012 Status:Case Deferred HQ File :01/82/050/00490/AM12/ RLA File :05/24/040/00116/AM12/ Lic.No/Date:0510295739 05.07.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to call from the firm Certificate of Analysis for import items from the foreign supplier. Accordingly, the case has been deferred for 28.2.2012. 130
Case No.:34/16/82ALC4/2011
Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 31.01.2012 Status:Case Deferred HQ File :01/82/050/00492/AM12/ RLA File :03/95/040/01038/AM11/ Lic.No/Date:0310641073 07.07.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 131
Case No.:17/26/82ALC4/2011
Party Name:CTX LIFESCIENCES PVT LTD, 31.01.2012 Status:Case Deferred HQ File :01/82/050/00700/AM12/ RLA File :03/94/040/00302/AM12/ Lic.No/Date:0310642596 15.07.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 132 Case No.:1/23/82ALC4/2011 Party Name:MEDISPRAY LABORATORIES PVT. LTD. 31.01.2012 Status:Case Approved Lic.No/Date:0310642543
HQ File :01/82/050/00653/AM12/ RLA File :03/95/040/00264/AM12/ 15.07.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities decided to ratify norms under Para 4.7 of HBP in line with the earlier cases approved as per details below, or as applied by the firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed 1 no. of inhaler Aerodini 100 mg Inhaler (200 MD)/Bulmol 100 mcg inhaler (200 MD)/Salcross HFA 100 mcg Inhaler (200 MD)/Salbutamol Pressurised Inhalation BP 100 mcg (200 MD) with 58 mcl Aerosol Valve and 19 ml Aluminium can. 1 No inhaler 1 2 3 4 5 Salbutamol 58 mcl Aerosol Valves 19 ml aluminium Can 0.48 mm OD Actuators with Dust Cover/caps 1,1,1,2 Tetrafluoroethane (HFA 134A Propellant) 0.02 gms As per packing policy As per packing policy As per packing policy 18.20 gms Salbutamol 100 mcg Inhaler (200 MD)/Asthalin HFA 100 mcg Inhaler (200 MD)/Salvent HFA 100 mcg Inhaler (200 MD)/Salbutateg 100 mcg Inhaler (200 MD)/Salbutamol Pressurised Inhalation BP 100 1 no of inhaler 1 2 3 4 5 Salbutamol 50 mcl Aerosol Valves 19 ml aluminium can 0.48 mm OD Actuators with Dus covers/caps 0.020 gms As per packing policy As per packing policy As per packing policy 14.40 gms
mcg (200 MD) with 50 mcl Aerosol Valve and 19 ml Aluminium Can 1,1,1,2,Tetrafluoroethane (HFA 134 A Propellant) Beclometasona Dipropionate 50 mcg Inhaler (200 MD)/Beclocross 50 mcg Inhaler (200 MD)/Beclocip 50 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 50 mcg Inhaler (200 MD) with 63 mcl Aerosol Valve and 19 ml aluminium Can. 1 2 3 4 5 6 Beclomethasone Dipropionate 63 mcl Aerosol Valves 19 ml aluminium Can 0.48 mm OD Actuators with Dus covers/caps 1,1,1,2,Tetrafluoroethane (HFA 134 A Propellant) Ethanol 0.01 gms as per packing policy as per packing policy as per packing policy 17.74 gms 0.456 gms Beclometasona Dipropionate 250mcg Inhaler (200MD) / Beclocip 250mcg HFA Inhaler (200MD) / Beclometasone Pressurised 250mcg Inhaler (200MD) with 63mcl Aerosol Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 BECLOMETHASONE DIPROPIONATE 63mcl AEROSOL VALVES 19ml ALUMINIUM CAN 0.48 mm OD ACTUATORS WITH DUST COVERS /CAPS 1,1,1,2,Tetrafluoroethane (HFA 134A Propellant) ETHANOL 0.05 gms As per packing policy As per packing policy As per packing policy 15.90 gms 2.28 gms Budespray 200mcg 1 no of 1 BUDESONIDE 0.04 gms
HFA Inhaler (200MD) / Budesonide Inhaler 200mcg (200MD) with 58mcl Aerosol Valve and 19ml Aluminium Can inhaler 2 3 4 5 58 mcl AEROSOL VALVES 19ml ALUMINIUM CAN 0.48 mm OD ACTUATORS WITH DUST COVERS /CAPS 1,1,1,2,Tetrafluoroethane (HFA 134A Propellant) As per packing policy As per packing policy As per packing policy 18.2 gms Budespray 100mcg HFA Inhaler (200MD) / Budesonide Inhaler 100mcg (200MD) Valve and 19ml Aluminium Can 1 no. of inhaler 1 2 3 4 5 BUDESONIDE 19ml ALUMINIUM CAN 0.48 mm OD ACTUATORS WITH DUST COVERS /CAPS 1,1,1,2,Tetrafluoroethane (HFA 134A Propellant) 0.02 gms As per packing policy As per packing policy As per packing policy 18.2 gms Asthalin 100 mcg HFA Inhaler (300 MD)/Asthavent 100 1 no of inhaler 1 SALBUTAMOL 0.03 gms
mcg HFA inhaler (300 MD)/Salbutamol Pressurised Inhalation BP 100 mcg (300 MD) with 50 mcl Aerosol Valve and 20 ml Aluminium Can 2 3 4 5 50 mcl AEROSOL VALVES 20 ml ALUMINIUM CAN 0.48 mm OD ACTUATORS WITH DUST COVERS /CAPS 1,1,1,2,Tetrafluoroethane (HFA 134A Propellant) As per packing policy As per packing policy As per packing policy 19.8 gms Fluticort Plus 25mcg HFA Inhaler (120MD) / Salmeterol 25mg and Fluticasone Propionate 125mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 SALMETEROL FLUTICASONE PROPIONATE 14ml ALUMINIUM CAN 0.48 mm OD ACTUATORS WITH DUST COVERS /CAPS 1,1,1,2,Tetrafluoroethane (HFA 134A Propellant) 0.003 gms 0.015 gms As per packing policy As per packing policy As per packing policy 12.5 gms
7 ETHANOL 0.256 gms Fluticort Plus 250mcg HFA Inhaler (120MD) / Salmeterol 25mcg and Fluticasone Propionate 250mcg Inhaler (120MD) / Flunacross S 250mcg HFA Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALMETEROL 14ml ALUMINIUM CAN 0.48 mm OD ACTUATORS WITH DUST COVERS /CAPS 1,1,1,2,Tetrafluoroethane (HFA 134A Propellant) ETHANOL 0.003 gms 0.03 gms As per packing policy As per packing policy As per packing policy 12.5 gms 0.256 gms The above norms are applicable subject to the condition that: Import of HFA 134 A Propellant and its quantity is subject to NOC from Ministry of Environment and Forests. Requirement of HFA 134 A Propellant is inclusive of allowances for permissible loss in weight on storage and primary losses. The firm will maintain separate record on HFA 134 A Propellant import and consumption. 133 Case No.:11/26/82ALC4/2011 Party Name:ARCH PHARMALABS LTD 31.01.2012 Status:Case Deferred
HQ File :01/82/050/00694/AM12/ RLA File :03/94/040/00317/AM12/ Lic.No/Date:0310642955 19.07.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 134 Case No.:5/23/82ALC4/2011 Party Name:MEDISPRAY LABORATORIES PVT. LTD. 31.01.2012 Status:Case Approved HQ File :01/82/050/00657/AM12/ RLA File :03/95/040/00297/AM12/ Lic.No/Date:0310643130 19.07.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities decided to ratify norms under Para 4.7 of HBP in line with the earlier cases approved as per details below, or as applied by the firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed 1 no. of inhaler Aerodini 100 mg Inhaler (200 MD)/Bulmol 100 mcg inhaler (200 MD)/Salcross HFA 100 mcg Inhaler (200 MD)/Salbutamol Pressurised Inhala솗on BP 100 mcg (200 MD) with 58 mcl Aerosol Valve and 19 ml Aluminium can. 1 no of inhaler 1 2 3 4 5 Salbutamol 58 mcl Aerosol Valves 19 ml aluminium Can 0.48 mm OD Actuators with Dust Cover/caps 1,1,1,2 Tetrafluoroethane (HFA 134A Propellant) 0.02 gms As per packing policy As per packing policy 18.20 gms Salbutamol 100 mcg Inhaler (200 MD)/Asthalin HFA 100 mcg Inhaler (200 MD)/Salvent HFA 100 1 no of inhaler 1 2 Salbutamol 50 mcl Aerosol Valves 0.020 gms
mcg Inhaler (200 MD)/Salbutateg 100 mcg Inhaler (200 MD)/Salbutamol with 50 mcl Aerosol Valve and 19 ml Aluminium Can 3 4 5 19 ml aluminium can 0.48 mm OD Actuators with Dus covers/caps 1,1,1,2,Tetrafluoroethane (HFA 134 A Propellant) 14.40 gms Beclometasona Dipropionate 50 mcg Inhaler (200 MD)/Beclocross 50 mcg Inhaler (200 MD)/Beclocip 50 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 50 mcg Inhaler (200 MD) with 63 mcl Aerosol Valve and 19 ml aluminium Can. 1 2 3 4 5 6 Beclomethasone Dipropionate 63 mcl Aerosol Valves 19 ml aluminium Can (HFA 134 A Propellant) Ethanol 0.02 gms as per packing policy 17.74 gms 0.456 gms Beclometasona Dipropionate 250mcg Inhaler (200MD) / Beclocip 250mcg HFA Inhaler (200MD) / Beclometasone Pressurised 250mcg Inhaler (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 BECLOMETHASONE DIPROPIONATE 19ml ALUMINIUM CAN 0.48 mm OD ACTUATORS WITH DUST COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.06gms 15.90 gms 2.28 gms
Budespray 200mcg HFA Inhaler (200MD) / Budesonide Inhaler 200mcg (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 BUDESONIDE 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.04 gms 18.2 gms Budespray 100mcg HFA Inhaler (200MD) 100mcg (200MD) Valve and 19ml Aluminium Can 1 2 3 4 5 BUDESONIDE 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.02 gms 18.2 gms Asthalin 100 mcg HFA Inhaler (300 MD)/Asthavent 100 1 no of inhaler 1 SALBUTAMOL 0.04 gms
mcg HFA inhaler (300 MD)/Salbutamol Pressurised Inhala솗on BP 100 mcg (300 MD) with 50 mcl Aerosol Valve and 20 ml Aluminium Can 2 3 4 5 50 mcl AEROSOL VALVES 20 ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 19.8 gms Flu솗cort Plus ‐ 25mcg HFA Inhaler (120MD) / Salmeterol 25mg and Flu솗casone Propionate 125mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.003 gms 0.015 gms 12.5 gms 0.256 gms
7 Flu솗cort Plus ‐ (120MD) / Salmeterol 25mcg and Flu솗casone Propionate 250mcg Inhaler (120MD) / Flunacross S ‐ (120MD) with 63mcl Aerosol Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.003 gms 0.03 gms 12.5 gms 0.256 gms The above norms are applicable subject to the condition that: Import of HFA 134 A Propellant and its quantity is subject to NOC from Ministry of Environment and Forests. Requirement of HFA 134 A Propellant is inclusive of allowances for permissible loss in weight on storage and primary losses. The firm will maintain separate record on HFA 134 A Propellant import and consumption. 135 Case No.:10/18/82ALC4/2011 Party Name:ELDER PHARMACEUTICALS LTD., Meet No/Date:44/82ALC4/2011 31.01.2012 Status:Case Deferred HQ File :01/82/050/00514/AM12/ RLA File :03/94/040/00289/AM12/ Lic.No/Date:0310643401 20.07.2011 Defer Date:28.02.2012
Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 136
Case No.:2/19/82ALC4/2011
Party Name:ARCH PHARMALABS LTD 31.01.2012 Status:Case Deferred HQ File :01/82/050/00516/AM12/ RLA File :03/94/040/00014/AM12/ Lic.No/Date:0310643597 21.07.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 137
Case No.:4/26/82ALC4/2011
Party Name:GALENTIC PHARMA (INDIA) PVT.LTD. 31.01.2012 Status:Case Deferred HQ File :01/82/050/00687/AM12/ RLA File :03/94/040/00352/AM12/ Lic.No/Date:0310643997 22.07.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 138
Case No.:12/26/82ALC4/2011
Party Name:CTX LIFESCIENCES PVT LTD, 31.01.2012 Status:Case Deferred HQ File :01/82/050/00695/AM12/ RLA File :03/94/040/00244/AM12/ Lic.No/Date:0310644247 25.07.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 139 Case No.:36/26/82ALC4/2011 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 31.01.2012 Status:Case Approved HQ File :01/82/050/00719/AM12/ RLA File :31/83/040/00084/AM12/ Lic.No/Date:3110049428 26.07.2011 Defer Date: Decision : The Committee considered the case as per agenda and in the light of written comments forwarded by Department of Chemicals and Petrochemicals vide their U.O No. 14010/39/2011Ch. II dated 16.1.2012 and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v1 HBP as per details below or as applied by the firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowedkg/kg 2,3,6 Trimethyl Phenol (TMO) 1 kg 1 2 Meta Cresol Methanol 0.882 0.575
3 Catalyst 0.027 140
Case No.:42/19/82ALC4/2011
Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 31.01.2012 Status:Case Approved HQ File :01/82/050/00556/AM12/ RLA File :31/83/040/00080/AM12/ Lic.No/Date:3110049430 26.07.2011 Defer Date: Decision : The Committee considered the case as per agenda and in the light of written comments forwarded by Department of Chemicals and Petrochemicals vide their U.O No. 14010/39/2011Ch. II dated 16.1.2012 and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v1 HBP as per details below or as applied by the firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowedkg/kg 2,5Dimethyl Phenol (2,5 Xylenol) solid 1 kg 1 2 3 Meta Cresol Methanol Catalyst 0.984 0.349 0.027 141
Case No.:45/19/82ALC4/2011
Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 31.01.2012 Status:Case Approved HQ File :01/82/050/00559/AM12/ RLA File :31/83/040/00081/AM12/ Lic.No/Date:3110049481 27.07.2011 Defer Date: Decision : The Committee considered the case as per agenda and in the light of written comments forwarded by Department of Chemicals and Petrochemicals vide their U.O No. 14010/39/2011Ch. II dated 16.1.2012 and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v1 HBP as per details below or as applied by the firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowedkg/kg Tetra Methyl BisphenolA (TMBPA)) 1 kg 1 2 3 Meta Cresol Methanol Catalyst 0.853 1.201 0.800 142 Case No.:55/26/82ALC4/2011 Party Name:TIDE INDUSTRIES 31.01.2012 Status:Case Deferred
HQ File :01/82/050/00738/AM12/ RLA File :34/24/040/00075/AM12/ Lic.No/Date:3410031091 28.07.2011 Defer Date:28.02.2012 Decision : The committee considered the case as per agenda and in the light of written comments of Department of Chemicals and Petrochemicals forwarded vide letter dated 3.11.2011 decided to call following information from the firm: Authentic/printed technical literature in support of % yield or norms applied for import. Chemical composition and specification of export item and import item. Production of export item for the past two years upto September, 2011 and corresponding consumption of each input duly certified by CA. Details of byproducts/coproduces formed and their recovery in quantity and value. 143
Case No.:1/24/82ALC4/2011
Party Name:PARABOLIC DRUGS LTD., 31.01.2012 Status:Case Deferred HQ File :01/82/050/00662/AM12/ RLA File :05/24/040/00150/AM12/ Lic.No/Date:0510298306 01.08.2011 Defer Date:28.02.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 144
Case No.:2/24/82ALC4/2011
Party Name:PARABOLIC DRUGS LTD., 31.01.2012 Status:Case Deferred HQ File :01/82/050/00663/AM12/ RLA File :05/24/040/00149/AM12/ Lic.No/Date:0510298304 01.08.2011 Defer Date:28.02.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 145
Case No.:3/24/82ALC4/2011
Party Name:PARABOLIC DRUGS LTD., 31.01.2012 Status:Case Deferred HQ File :01/82/050/00664/AM12/ RLA File :05/24/040/00083/AM12/ Lic.No/Date:0510298301 01.08.2011 Defer Date:28.02.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 146 Case No.:12/25/82ALC4/2011 Party Name:GOPINATH CHEMTECH LTD., 31.01.2012 Status:Case Deferred HQ File :01/82/050/00679/AM12/ RLA File :08/24/040/00107/AM12/ Lic.No/Date:0810102095 Defer
03.08.2011 Date:28.02.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 147
Case No.:21/28/82ALC4/2011
Party Name:AMOLI ORGANICS PVT. LTD., 31.01.2012 Status:Case Deferred HQ File :01/82/050/00791/AM12/ RLA File :03/94/040/00337/AM12/ Lic.No/Date:0310646104 03.08.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to call from the firm the Certificate of Analusis for import items from the foreign supplier. Accordingly, the case has been deferred for 28.2.2012. 148
Case No.:20/29/82ALC4/2011
Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. 31.01.2012 Status:Case Deferred HQ File :01/82/050/00819/AM12/ RLA File :03/94/040/00413/AM12/ Lic.No/Date:0310646512 04.08.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in light of written comments of Department of Chemicals and Petrochemicals forwarded vide their letter No. 14010/127/2011Ch. II dated 28.10.2011 decided to call from the firm the following information: Balanced chemical reaction showing all the reactants, product and by product with their molecular formula and molecular formula. Stagewise % yield on molecular weight basis alongwith justification supported with authentic/printed technical literature. Production of export item for the past three years and corresponding consumption of each input duly certified by Chartered Accountant. Details of isomers/by products formed in the process and its recovery in terms of quantity and value supported with documentary evidence. 149
Case No.:13/25/82ALC4/2011
Party Name:EMAMI LIMITED, 31.01.2012 Status:Case Deferred HQ File :01/82/050/00680/AM12/ RLA File :02/24/040/00060/AM12/ Lic.No/Date:0210163383 05.08.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to
150
Case No.:25/26/82ALC4/2011
Party Name:ENCUBE ETHICALS PVT LTD 31.01.2012 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:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 151
Case No.:50/26/82ALC4/2011
Party Name:PAB ORGANICS PVT.LTD, 31.01.2012 Status:Case Deferred HQ File :01/82/050/00733/AM12/ RLA File :34/24/040/00090/AM12/ Lic.No/Date:3410031224 08.08.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 152
Case No.:43/26/82ALC4/2011
Party Name:NECTAR LIFESCIENCES LIMITED, 31.01.2012 Status:Case Deferred HQ File :01/82/050/00726/AM12/ RLA File :22/24/040/00036/AM12/ Lic.No/Date:2210011760 09.08.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 153 Case No.:18/26/82ALC4/2011 31.01.2012 Status:Case Approved HQ File :01/82/050/00701/AM12/ RLA File :03/94/040/00425/AM12/ Lic.No/Date:0310647629 10.08.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v 1 in line with the earlier recommendations, as per details below or as applied by the firm, whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed 1 no. of inhaler Aerodini 100 mg Inhaler (200 MD)/Bulmol 100 mcg inhaler (200 MD)/Salcross HFA 100 mcg Inhaler (200 MD)/Salbutamol 1 no of inhaler 1 2 3 Salbutamol 58 mcl Aerosol Valves 19 ml aluminium Can 0.02 gms
with 58 mcl Aerosol Valve and 19 ml Aluminium can. 4 5 0.48 mm OD Actuators with Dust Cover/caps 1,1,1,2 Tetrafluoroethane (HFA 134A Propellant) 18.20 gms Salbutamol 100 mcg Inhaler (200 MD)/Asthalin HFA 100 mcg Inhaler (200 MD)/Salvent HFA 100 mcg Inhaler (200 MD)/Salbutateg 100 mcg Inhaler (200 MD)/Salbutamol with 50 mcl Aerosol Valve and 19 ml Aluminium Can 1 no of inhaler 1 2 3 4 5 Salbutamol 50 mcl Aerosol Valves 19 ml aluminium can (HFA 134 A Propellant) 0.020 gms 14.40 gms Beclometasona Dipropionate 50 mcg Inhaler (200 MD)/Beclocross 50 mcg Inhaler (200 MD)/Beclocip 50 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 50 mcg Can. 1 no of inhaler 1 2 3 4 5 Beclomethasone Dipropionate 63 mcl Aerosol Valves 19 ml aluminium Can (HFA 134 A Propellant) 0.07gms 17.74 gms 0.456 gms
6 Ethanol Beclometasona Dipropionate 100 mcg Inhaler (200 MD)/Beclocip 100 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 100 mcg Can 1 no of inhaler 1 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.08gms As pr packing policy 17.288 gms 0.912 gms Beclometasona Dipropionate 200mcg Inhaler 200mcg HFA Inhaler (200MD) / Beclometasone Pressurised 200mcg Inhaler (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.04 gms 16.37 gms 1.824 gms Beclometasona Dipropionate 1 no of inhaler 1 0.05gms
250mcg Inhaler (200MD) / Beclometasone Pressurised 250mcg Inhaler (200MD) Valve and 19ml Aluminium Can 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 15.90 gms 2.28 gms Budespray 200mcg HFA Inhaler (200MD) 200mcg (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 BUDESONIDE 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.09gms 18.2 gms Budespray 100mcg HFA Inhaler (200MD) 100mcg (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 BUDESONIDE 19ml ALUMINIUM CAN 0.02 gms
4 5 COVERS /CAPS (HFA 134A Propellant) 18.2 gms Salmeterol Inhaler 25mcg (120MD) with 63mcl Aerosol Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.05 gms 12.50 gms 0.256 gms Flu솗cort Plus ‐ 25mcg HFA Inhaler (120MD) / Salmeterol 25mg and Flu솗casone Propionate 125mcg Inhaler (120MD) 1 no of inhaler 1 2 3 SALMETEROL 0.003 gms 0.015 gms
Valve and 14ml Aluminium Can 4 5 6 7 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 12.5 gms 0.256 gms Flu솗cort Plus ‐ (120MD) / Salmeterol 25mcg and Flu솗casone Propionate 250mcg Inhaler (120MD) / Flunacross S ‐ (120MD) with 63mcl Aerosol Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.003 gms 0.03 gms 12.5 gms 0.256 gms Flu솗cort Plus ‐ 50mcg HFA Inhaler (120MD) / Salmeterol 25mcg and Flu솗casone Propionate 50mcg 1 no of inhaler 1 2 SALMETEROL 0.003 gms 0.006 gms
Inhaler (120MD) / Flunacross S ‐ 50mcg HFA Inhaler (120MD) Valve and 14ml Aluminium Can 3 4 5 6 7 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL As per packing policy As per packing policy As per packing policy 12.5 gms 0.256 gms Beclomethasone Dipropionate 50mcg and Salbutamol 100mcg Inhaler (200MD) with 50mcl Aerosol Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALBUTAMOL 50 mcl AEROSOL VALVES 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.02 gms 0.01 gms 14.04 gms 0.36 gms Flu솗casone Propionate 50mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 14ml ALUMINIUM CAN 0.006 gms
4 5 6 COVERS /CAPS (HFA 134A Propellant) ETHANOL 12.5 gms 0.256 gms Flu솗casone Propionate 125mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 14ml ALUMINIUM CAN 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.015 gms 12.5 gms 0.256 gms Flu솗casone Propionate 250mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 63 mcl Aerosol vale 14ml ALUMINIUM CAN 0.03 gms
4 5 6 COVERS /CAPS (HFA 134A Propellant) ETHANOL 12.5 gms 0.256 gms Formoterol Fumarate Inhaler 12mcg (120MD) with 40mcl Aerosol Valve and 10ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 Formoterol Fumarate 40 mcl AEROSOL VALVES 10ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.0014 gms 7.84 gms 0.16 gms Formoterol Fumarate and Budesonide Inhaler 100/6mcg (120MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 BUDESONIDE Formoterol Fumarate 0.012 gms 0.0007 gms As per packing policy
4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) As per packing policy As per packing policy 12.2 gms Formoterol Fumarate and Budesonide Inhaler 200/6mcg (120MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 BUDESONIDE Formoterol Fumarate 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) Ethanol 0.0007 gms 0.024 gms As per packing policy As per packing policy As per packing policy 12.2 gms Nil The above norms are applicable subject to the condition that: Import of HFA 134 A Propellant and its quantity is subject to NOC from Ministry of Environment and Forests. Requirement of HFA 134 A Propellant is inclusive of allowances for permissible loss in weight on storage and primary losses. The firm will maintain separate record on HFA 134 A Propellant import and consumption
154 Case No.:37/26/82ALC4/2011 Party Name:R L FINE CHEM 31.01.2012 Status:Case Approved HQ File :01/82/050/00720/AM12/ RLA File :07/24/040/00171/AM12/ Lic.No/Date:0710081348 10.08.2011 Defer Date: Decision : The Committee considered the case as per agenda in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v1 on the basis of 80% yield as per details below or as applied by the firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowedkg/kg Sulphadoxine 1 kg 1 4Sulfanilamide5Methoxyl6Chloro Pyrimidine 1.27 kg/kg 155
Case No.:28/26/82ALC4/2011
Party Name:INTAS PHARMACEUTICALS LTD., 31.01.2012 Status:Case Deferred HQ File :01/82/050/00711/AM12/ RLA File :08/24/040/00114/AM12/ Lic.No/Date:0810102412 11.08.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 156
Case No.:2/22/82ALC4/2011
Party Name:STERLING AUXILIARIES PVT LTD 31.01.2012 Status:Case Deferred HQ File :01/82/050/00645/AM12/ RLA File :03/95/040/00303/AM12/ Lic.No/Date:0310648749 16.08.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 157 Case No.:3/22/82ALC4/2011 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 31.01.2012 Status:Case Approved HQ File :01/82/050/00646/AM12/ RLA File :31/83/040/00088/AM12/ Lic.No/Date:3110049781 16.08.2011 Defer Date: Decision : The Committee considered the case as per agenda and in the light of written comments forwarded by Department of Chemicals and Petrochemicals vide their U.O No. 14010/39/2011Ch. II dated 16.1.2012 and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v1 HBP as per details below or as applied by the firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowedkg/kg
Phenol Glycidyl Ether Adduct (PGE Adduct) 1 kg 1 2 3 Meta Cresol Methanol Catalyst 0.467 kg 0.506 kg 0.407 kg 158
Case No.:16/25/82ALC4/2011
Party Name:STERICAT GUTSTRINGS PVT. LTD. Meet No/Date:44/82ALC4/2011 31.01.2012 Status:Case Deferred HQ File :01/82/050/00683/AM12/ RLA File :05/24/040/00154/AM12/ Lic.No/Date:0510299727 17.08.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 159
Case No.:5/22/82ALC4/2011
Party Name:ELPPE CHEMICALS PRIVATE LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/00648/AM12/ RLA File :03/94/040/00391/AM12/ Lic.No/Date:0310649216 18.08.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in the light of written comments of Department of Chemicals & Petrochemicals forwarded vide letter No. 14010/115/2011Ch. II dated 3.10.2011 decided for request the firm to furnish past two years production of export item and corresponding consumption of each input duly certified by CA. Accordingly the case has been deferred for 28.2.2012. 160
Case No.:8/22/82ALC4/2011
Party Name:PRASOL CHEMICALS LIMITED 31.01.2012 Status:Case Approved HQ File :01/82/050/00651/AM12/ RLA File :03/95/040/00154/AM12/ Lic.No/Date:0310649496 19.08.2011 Defer Date: Decision : The Committee considered the case as per agenda and in the light of written comments forwarded by Department of Chemicals and Petrochemicals vide their U.O No. 14010/107/2011Ch. II dated 24.10.2011 and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v1 HBP as per details below or as applied by the firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowedkg/kg Mesityl Oxide 1 kg 1 Acetone 1.580kg/kg 161 Case No.:9/22/82ALC4/2011 Party Name:EMCURE PHARMACEUTICALS Status:Case
LTD. 31.01.2012 Deferred HQ File :01/82/050/00652/AM12/ RLA File :31/83/040/00103/AM12/ Lic.No/Date:3110049873 19.08.2011 Defer Date:31.01.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 162
Case No.:67/26/82ALC4/2011
Party Name:LUPIN LIMITED 31.01.2012 Status:Case Approved HQ File :01/82/050/00750/AM12/ RLA File :03/95/040/00384/AM12/ Lic.No/Date:0310649476 19.08.2011 Defer Date: Decision : Commi컦�ee considered case as per agenda and in light of earlier decision taken in the mee솗ng No. 10/82 dated 9.6.2009 and in consulta솗on with technical authority present in mee솗ng, decided to ra솗fy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Cefprozil 1 Kg. 1. 7‐Phenylacetamido‐3‐Chloromethyl Cephalosporanic Acid P‐Methoxybenzyl Ester (GCLE) 3.238 kg 2 D(‐) Alpha Parahydroxy Phenylglycine Methyl Potassium Dane Salt (M.K.) 1.050 kg 3. Acetone 2.41 kg 4. Dimethylaniline 0.25 kg 5. Methanol 0.68 kg 6. Methylene Chloride 21.74 kg 7. Dimethyl Formamide 4.91 kg 8. Hexamethyl Disilazane 0.42 kg 9. Trimethyl Chlorosilane 0.273 kg 10. Ethyl Acetate 1.92 kg 11. N,O‐Bis (Trimethyl Silyl) Acetamide 0.004 kg 12. Ethyl Chloro Formate 0.398 kg 13. Trifluoro Ace솗c Acid 2.986 kg 14. Isopropyl Alcohol 7.38 kg 15. Triphenyl Phosphine 1.851 kg 16. Phosphorous Pentachloride (PCL5) 1.571 kg 17 Ac솗vated Carbon 0.100 kg 18. Caus솗c Soda 1.63 kg 19. Sodium Hydrosulphite 0.004 kg RA concerned may take further necessary ac솗on as per above decision of NC.
163 Case No.:47/26/82ALC4/2011 Party Name:ADCOCK INGRAM LTD, 31.01.2012 Status:Case Approved HQ File :01/82/050/00730/AM12/ RLA File :07/24/040/00204/AM12/ Lic.No/Date:0710081689 23.08.2011 Defer Date: Decision : The Committee considered the case as per agenda and in the light of earlier decision taken in Meeting No. 30/82 dated 26.10.2010 and in consultation with the technical authorities present in the meeting decided to fix adhoc norms under para 4.7 or as applied by the firm whichever is lower; Export product Exp. Qty. Sl.No. Import items Qty. allowed Mypaid capsules each containing paracetamol 260MG+ibuprofen 200MG + Sodium stearyl Fumarate 6.5 MG 1 capsule 1. Paracetamol BP/USP/EP Crystals(Rhodapapa Crystals) 255 mg 2. Ibuprofen 25 BP/USP/EP 204 mg 3. Sodium stearyl Fumarate BP/USP/EP 6.5 mg RA concerned may take further necessary action as per above decision of NC 164
Case No.:64/26/82ALC4/2011
Party Name:S.R.S.PHARMACEUTICALS PVT. LTD. 31.01.2012 Status:Case Deferred HQ File :01/82/050/00747/AM12/ RLA File :03/95/040/00396/AM12/ Lic.No/Date:0310649795 23.08.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 165
Case No.:34/32/82ALC4/2011
Party Name:VINEET LABORATORIES PRIVATE LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/00915/AM12/ RLA File :09/24/040/00157/AM12/ Lic.No/Date:0910048352 23.08.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 166 Case No.:3/27/82ALC4/2011 31.01.2012 Status:Case Approved HQ File :01/82/050/00753/AM12/ RLA File :03/94/040/00466/AM12/ Lic.No/Date:0310650270 25.08.2011 Defer Date:
Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v 1 in line with the earlier recommendations, as per details below or as applied by the firm, whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed 1 no. of inhaler Aerodini 100 mg Inhaler (200 MD)/Bulmol 100 mcg inhaler (200 MD)/Salcross HFA 100 mcg Inhaler (200 MD)/Salbutamol with 58 mcl Aerosol Valve and 19 ml Aluminium can. 1 no of inhaler 1 2 3 4 5 Salbutamol 58 mcl Aerosol Valves 19 ml aluminium Can 0.48 mm OD Actuators with Dust Cover/caps 1,1,1,2 Tetrafluoroethane (HFA 134A Propellant) 0.02 gms 18.20 gms Salbutamol 100 mcg Inhaler (200 MD)/Asthalin HFA 100 mcg Inhaler (200 MD)/Salvent HFA 100 mcg Inhaler (200 MD)/Salbutateg 100 mcg Inhaler (200 MD)/Salbutamol with 50 mcl Aerosol Valve and 19 ml Aluminium Can 1 no of inhaler 1 2 3 4 5 Salbutamol 50 mcl Aerosol Valves 19 ml aluminium can (HFA 134 A Propellant) 0.020 gms 14.40 gms Beclometasona 1 no of 1 Beclomethasone Dipropionate 0.10gms
Dipropionate 50 mcg Inhaler (200 MD)/Beclocross 50 mcg Inhaler (200 MD)/Beclocip 50 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 50 mcg Can. inhaler 2 3 4 5 6 63 mcl Aerosol Valves 19 ml aluminium Can (HFA 134 A Propellant) Ethanol 17.74 gms 0.456 gms Beclometasona Dipropionate 100 mcg Inhaler (200 MD)/Beclocip 100 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 100 mcg Can 1 no of inhaler 1 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.11gms As pr packing policy 17.288 gms 0.912 gms Beclometasona Dipropionate 200mcg Inhaler 200mcg HFA Inhaler (200MD) / 1 no of inhaler 1 2 0.06 gms
( ) / Beclometasone Pressurised 200mcg Inhaler (200MD) Valve and 19ml Aluminium Can 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 16.37 gms 1.824 gms Beclometasona Dipropionate 250mcg Inhaler (200MD) / Beclometasone Pressurised 250mcg Inhaler (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.07gms 15.90 gms 2.28 gms Budespray 200mcg HFA Inhaler (200MD) 200mcg (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 BUDESONIDE 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.12gms 18.2 gms
Budespray 100mcg HFA Inhaler (200MD) 100mcg (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 BUDESONIDE 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.02 gms 18.2 gms Salmeterol Inhaler 25mcg (120MD) with 63mcl Aerosol Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.06 gms 12.50 gms 0.256 gms
Flu솗cort Plus ‐ 25mcg HFA Inhaler (120MD) / Salmeterol 25mg and Flu솗casone Propionate 125mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.003 gms 0.015 gms 12.5 gms 0.256 gms Flu솗cort Plus ‐ (120MD) / Salmeterol 25mcg and Flu솗casone Propionate 250mcg Inhaler (120MD) / Flunacross S ‐ (120MD) with 63mcl Aerosol Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.003 gms 0.03 gms 12.5 gms 0.256 gms
7 ETHANOL Flu솗cort Plus ‐ 50mcg HFA Inhaler (120MD) / Salmeterol 25mcg and Flu솗casone Propionate 50mcg Inhaler (120MD) / Flunacross S ‐ 50mcg HFA Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.003 gms 0.006 gms As per packing policy As per packing policy As per packing policy 12.5 gms 0.256 gms Beclomethasone Dipropionate 50mcg and Salbutamol 100mcg Inhaler (200MD) with 50mcl Aerosol Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 SALBUTAMOL 50 mcl AEROSOL VALVES 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.02 gms 0.02 gms 14.04 gms 0.36 gms
7 ETHANOL Flu솗casone Propionate 50mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.006 gms 12.5 gms 0.256 gms Flu솗casone Propionate 125mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 14ml ALUMINIUM CAN 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.015 gms 12.5 gms 0.256 gms
7 ETHANOL Flu솗casone Propionate 250mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 63 mcl Aerosol vale 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.03 gms 12.5 gms 0.256 gms Formoterol Fumarate Inhaler 12mcg (120MD) with 40mcl Aerosol Valve and 10ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 Formoterol Fumarate 40 mcl AEROSOL VALVES 10ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.0014 gms 7.84 gms 0.16 gms
Formoterol Fumarate and Budesonide Inhaler 100/6mcg (120MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 BUDESONIDE Formoterol Fumarate 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.012 gms 0.0007 gms As per packing policy As per packing policy As per packing policy 12.2 gms Formoterol Fumarate and Budesonide Inhaler 200/6mcg (120MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 BUDESONIDE Formoterol Fumarate 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) Ethanol 0.0007 gms 0.024 gms As per packing policy As per packing policy As per packing policy 12.2 gms Nil The above norms are applicable subject to the condition that:
Import of HFA 134 A Propellant and its quantity is subject to NOC from Ministry of Environment and Forests. Requirement of HFA 134 A Propellant is inclusive of allowances for permissible loss in weight on storage and primary losses. The firm will maintain separate record on HFA 134 A Propellant import and consumption 167
Case No.:33/32/82ALC4/2011
Party Name:DR REDDYS LABORATORIES LIMITED 31.01.2012 Status:Case Approved HQ File :01/82/050/00914/AM12/ RLA File :09/24/040/00228/AM12/ Lic.No/Date:0910048380 25.08.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting, decided to ratify norms under Para 4.7 of HBP v1 on the basis of comparison of data available as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Ramipril 1 kg 1 N[1(S)Ethoxy Carbonyl3Phenyl Propyl] LAlanine (or) ECPP Alanine 0.98kg/kg 2. Methylene Chloride 5.01 kg/kg 3. (S,S,S)2Azabicyclo[3,3,0] Octane 3 Carboxylic Acid Benzyl Ester Hydrochloride 0.83 kg.kg 168
Case No.:38/32/82ALC4/2011
Party Name:GRANULES INDIA LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/00919/AM12/ RLA File :09/24/040/00239/AM12/ Lic.No/Date:0910048379 25.08.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 169 Case No.:21/29/82ALC4/2011 Party Name:AARTI INDUSTRIES LIMITED 31.01.2012 Status:Case Approved HQ File :01/82/050/00820/AM12/ RLA File :03/94/040/00467/AM12/ Lic.No/Date:0310650671 26.08.2011 Defer Date: Decision : The Committee considered the case as per agenda and in the light of written comments forwarded by Department of Chemicals and Petrochemicals vide their U.O No. 14010/137/2011Ch.II dated 22.12.2011 and in consultation with the technical authorities present in the meeting, decided to fix adhoc norms under para 4.7 or as applied by the firm whichever is lower;
Export product Exp. Qty. Sl.No. Import items Qty. allowed 2,4 Dichloro Aniline 1 kg 1 Meta Dichloro Benzene 1.13 kg 170
Case No.:6/28/82ALC4/2011
Party Name:CADILA HEALTHCARE LTD., 31.01.2012 Status:Case Deferred HQ File :01/82/050/00776/AM12/ RLA File :08/24/040/00092/AM12/ Lic.No/Date:0810102939 29.08.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 171
Case No.:30/32/82ALC4/2011
Party Name:MEDCHL CHEMICALS AND PHARMACEUTICALS PVT LTD 31.01.2012 Status:Case Approved HQ File :01/82/050/00911/AM12/ RLA File :09/24/040/00231/AM12/ Lic.No/Date:0910048496 29.08.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/157/2011PI(Norms)I dated 3.1.2012 and in consultation with technical authority present in meeting, decided to ratify norms Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg D2 Aminobutanol 1 kg 1 2 3 DL2 Aminobutanol Monosodium Glutamate Toluene 2.2642 0.647 0.60 172
Case No.:38/31/82ALC4/2011
Party Name:NECTAR LIFESCIENCES LIMITED, 31.01.2012 Status:Case Deferred HQ File :01/82/050/00864/AM12/ RLA File :22/24/040/00041/AM12/ Lic.No/Date:2210011844 01.09.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to
173 Case No.:22/28/82ALC4/2011 31.01.2012 Status:Case Approved HQ File :01/82/050/00792/AM12/ RLA File :03/94/040/00497/AM12/ Lic.No/Date:0310651339 02.09.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v 1 in line with the earlier recommendations, as per details below or as applied by the firm, whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed 1 no. of inhaler Aerodini 100 mg Inhaler (200 MD)/Bulmol 100 mcg inhaler (200 MD)/Salcross HFA 100 mcg Inhaler (200 MD)/Salbutamol with 58 mcl Aerosol Valve and 19 ml Aluminium can. 1 no of inhaler 1 2 3 4 5 Salbutamol 58 mcl Aerosol Valves 19 ml aluminium Can 0.48 mm OD Actuators with Dust Cover/caps 1,1,1,2 Tetrafluoroethane (HFA 134A Propellant) 0.02 gms 18.20 gms Salbutamol 100 mcg Inhaler (200 MD)/Asthalin HFA 100 mcg Inhaler (200 MD)/Salvent HFA 100 mcg Inhaler (200 MD)/Salbutateg 100 mcg Inhaler (200 MD)/Salbutamol 1 no of inhaler 1 2 3 4 Salbutamol 50 mcl Aerosol Valves 19 ml aluminium can 0.020 gms 14.40 gms
with 50 mcl Aerosol Valve and 19 ml Aluminium Can 5 (HFA 134 A Propellant) Beclometasona Dipropionate 50 mcg Inhaler (200 MD)/Beclocross 50 mcg Inhaler (200 MD)/Beclocip 50 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 50 mcg Can. 1 no of inhaler 1 2 3 4 5 6 Beclomethasone Dipropionate 63 mcl Aerosol Valves 19 ml aluminium Can (HFA 134 A Propellant) Ethanol 0.13gms 17.74 gms 0.456 gms Beclometasona Dipropionate 100 mcg Inhaler (200 MD)/Beclocip 100 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 100 mcg Can 1 no of inhaler 1 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.14gms As pr packing policy 17.288 gms 0.912 gms
Beclometasona Dipropionate 200mcg Inhaler 200mcg HFA Inhaler (200MD) / Beclometasone Pressurised 200mcg Inhaler (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.08 gms 16.37 gms 1.824 gms Beclometasona Dipropionate 250mcg Inhaler (200MD) / Beclometasone Pressurised 250mcg Inhaler (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.09gms 15.90 gms 2.28 gms Budespray 200mcg HFA Inhaler (200MD) 200mcg (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 BUDESONIDE 19ml ALUMINIUM CAN 0.15gms
4 5 COVERS /CAPS (HFA 134A Propellant) 18.2 gms Budespray 100mcg HFA Inhaler (200MD) 100mcg (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 BUDESONIDE 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.02 gms 18.2 gms Salmeterol Inhaler 25mcg (120MD) with 63mcl Aerosol Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS 0.07 gms 12.50 gms
5 6 (HFA 134A Propellant) ETHANOL 0.256 gms Flu솗cort Plus ‐ 25mcg HFA Inhaler (120MD) / Salmeterol 25mg and Flu솗casone Propionate 125mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.003 gms 0.015 gms 12.5 gms 0.256 gms Flu솗cort Plus ‐ (120MD) / Salmeterol 25mcg and Flu솗casone Propionate 250mcg Inhaler (120MD) / Flunacross S ‐ (120MD) with 63mcl 1 no of inhaler 1 2 3 4 SALMETEROL 14ml ALUMINIUM CAN 0.003 gms 0.03 gms
Aerosol Valve and 14ml Aluminium Can 5 6 7 COVERS /CAPS (HFA 134A Propellant) ETHANOL 12.5 gms 0.256 gms Flu솗cort Plus ‐ 50mcg HFA Inhaler (120MD) / Salmeterol 25mcg and Flu솗casone Propionate 50mcg Inhaler (120MD) / Flunacross S ‐ 50mcg HFA Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.003 gms 0.006 gms As per packing policy As per packing policy As per packing policy 12.5 gms 0.256 gms Beclomethasone Dipropionate 50mcg and Salbutamol 100mcg Inhaler (200MD) with 50mcl Aerosol Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 SALBUTAMOL 50 mcl AEROSOL VALVES 19ml ALUMINIUM CAN 0.02 gms 0.03 gms
5 6 7 COVERS /CAPS (HFA 134A Propellant) ETHANOL 14.04 gms 0.36 gms Flu솗casone Propionate 50mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.006 gms 12.5 gms 0.256 gms Flu솗casone Propionate 125mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 14ml ALUMINIUM CAN 19ml ALUMINIUM CAN 0.015 gms
5 6 7 COVERS /CAPS (HFA 134A Propellant) ETHANOL 12.5 gms 0.256 gms Flu솗casone Propionate 250mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 63 mcl Aerosol vale 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.03 gms 12.5 gms 0.256 gms Formoterol Fumarate Inhaler 12mcg (120MD) with 40mcl Aerosol Valve and 10ml Aluminium Can 1 no of inhaler 1 2 3 4 Formoterol Fumarate 40 mcl AEROSOL VALVES 10ml ALUMINIUM CAN COVERS /CAPS 0.0014 gms 7.84 gms
5 6 (HFA 134A Propellant) ETHANOL 0.16 gms Formoterol Fumarate and Budesonide Inhaler 100/6mcg (120MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 BUDESONIDE Formoterol Fumarate 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.012 gms 0.0007 gms As per packing policy As per packing policy As per packing policy 12.2 gms Formoterol Fumarate and Budesonide Inhaler 200/6mcg (120MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 BUDESONIDE Formoterol Fumarate 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.0007 gms 0.024 gms As per packing policy As per packing policy As per packing policy 12.2 gms
7 p ) Ethanol Nil The above norms are applicable subject to the condition that: Import of HFA 134 A Propellant and its quantity is subject to NOC from Ministry of Environment and Forests. Requirement of HFA 134 A Propellant is inclusive of allowances for permissible loss in weight on storage and primary losses. The firm will maintain separate record on HFA 134 A Propellant import and consumption 174
Case No.:23/28/82ALC4/2011
31.01.2012 Status:Case Approved HQ File :01/82/050/00793/AM12/ RLA File :03/94/040/00496/AM12/ Lic.No/Date:0310651347 02.09.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v 1 in line with the earlier recommendations, as per details below or as applied by the firm, whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg Tenofovir Disoproxil Fumarate 1 kg 1 9‐[2‐(Phosphonyl Methoxy) Propyl] Adenine (PMPA) 0.8026 kg/kg 2 Chloromethyl Isopropyl Carbonate 2.0867 kg/kg 3. N‐Methyl 2‐ Pyrrolidone 3.297 kg/kg 4. Fumaric Acid 0.304 kg/kg 5 Methylene Dichloride 6.70 kg/kg 6. Isopropyl Acetate 2.35 kg/kg 175 Case No.:29/32/82ALC4/2011 Party Name:RA CHEM PHARMA LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/00910/AM12/ RLA File :09/24/040/00259/AM12/ Lic.No/Date:0910048529 02.09.2011 Defer Date:28.02.2012
Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 176
Case No.:9/32/82ALC4/2011
31.01.2012 Status:Case Deferred HQ File :01/82/050/00890/AM12/ RLA File :09/24/040/00242/AM12/ Lic.No/Date:0910048539 05.09.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 177
Case No.:14/32/82ALC4/2011
Party Name:SRINI PHARMACEUTICALS LTD., 31.01.2012 Status:Case Deferred HQ File :01/82/050/00895/AM12/ RLA File :09/24/040/00250/AM12/ Lic.No/Date:0910048565 05.09.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 178 Case No.:16/29/82ALC4/2011 31.01.2012 Status:Case Approved HQ File :01/82/050/00815/AM12/ RLA File :03/94/040/00501/AM12/ Lic.No/Date:0310651860 06.09.2011 Defer Date: Decision :The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v 1 in line with the earlier recommendations, as per details below or as applied by the firm, whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed 1 no. of inhaler Aerodini 100 mg Inhaler (200 MD)/Bulmol 100 mcg inhaler (200 MD)/Salcross HFA 100 mcg Inhaler (200 MD)/Salbutamol with 58 mcl Aerosol Valve and 19 ml Aluminium can. 1 no of inhaler 1 2 3 4 5 Salbutamol 58 mcl Aerosol Valves 19 ml aluminium Can 0.48 mm OD Actuators with Dust Cover/caps 1,1,1,2 Tetrafluoroethane (HFA 134A Propellant) 0.02 gms 18.20 gms
Salbutamol 100 mcg Inhaler (200 MD)/Asthalin HFA 100 mcg Inhaler (200 MD)/Salvent HFA 100 mcg Inhaler (200 MD)/Salbutateg 100 mcg Inhaler (200 MD)/Salbutamol with 50 mcl Aerosol Valve and 19 ml Aluminium Can 1 no of inhaler 1 2 3 4 5 Salbutamol 50 mcl Aerosol Valves 19 ml aluminium can (HFA 134 A Propellant) 0.020 gms 14.40 gms Beclometasona Dipropionate 50 mcg Inhaler (200 MD)/Beclocross 50 mcg Inhaler (200 MD)/Beclocip 50 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 50 mcg Can. 1 no of inhaler 1 2 3 4 5 6 Beclomethasone Dipropionate 63 mcl Aerosol Valves 19 ml aluminium Can (HFA 134 A Propellant) Ethanol 0.16gms 17.74 gms 0.456 gms Beclometasona Dipropionate 100 mcg Inhaler (200 1 no of inhaler 1 0.17gms
MD)/Beclocip 100 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 100 mcg Can 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL As pr packing policy 17.288 gms 0.912 gms Beclometasona Dipropionate 200mcg Inhaler 200mcg HFA Inhaler (200MD) / Beclometasone Pressurised 200mcg Inhaler (200MD) Valve and 19ml Aluminium Can 1 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.10 gms 16.37 gms 1.824 gms Beclometasona Dipropionate 250mcg Inhaler (200MD) / Beclometasone 1 no of inhaler 1 2 0.11gms
Pressurised 250mcg Inhaler (200MD) Valve and 19ml Aluminium Can 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 15.90 gms 2.28 gms Budespray 200mcg HFA Inhaler (200MD) 200mcg (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 BUDESONIDE 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.18gms 18.2 gms Budespray 100mcg HFA Inhaler (200MD) 100mcg (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 BUDESONIDE 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.02 gms 18.2 gms
Salmeterol Inhaler 25mcg (120MD) with 63mcl Aerosol Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.08 gms 12.50 gms 0.256 gms Flu솗cort Plus ‐ 25mcg HFA Inhaler (120MD) / Salmeterol 25mg and Flu솗casone Propionate 125mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 SALMETEROL 14ml ALUMINIUM CAN 0.003 gms 0.015 gms
6 7 COVERS /CAPS (HFA 134A Propellant) ETHANOL 12.5 gms 0.256 gms Flu솗cort Plus ‐ (120MD) / Salmeterol 25mcg and Flu솗casone Propionate 250mcg Inhaler (120MD) / Flunacross S ‐ (120MD) with 63mcl Aerosol Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.003 gms 0.03 gms 12.5 gms 0.256 gms Flu솗cort Plus ‐ 50mcg HFA Inhaler (120MD) / Salmeterol 25mcg and Flu솗casone Propionate 50mcg Inhaler (120MD) / Flunacross S ‐ 50mcg HFA Inhaler (120MD) 1 no of inhaler 1 2 3 SALMETEROL 14ml ALUMINIUM CAN 0.003 gms 0.006 gms As per packing policy
Valve and 14ml Aluminium Can 4 5 6 7 COVERS /CAPS (HFA 134A Propellant) ETHANOL As per packing policy As per packing policy 12.5 gms 0.256 gms Beclomethasone Dipropionate 50mcg and Salbutamol 100mcg Inhaler (200MD) with 50mcl Aerosol Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALBUTAMOL 50 mcl AEROSOL VALVES 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.02 gms 0.04 gms 14.04 gms 0.36 gms Flu솗casone Propionate 50mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 14ml ALUMINIUM CAN COVERS /CAPS 0.006 gms
5 6 (HFA 134A Propellant) ETHANOL 12.5 gms 0.256 gms Flu솗casone Propionate 125mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 14ml ALUMINIUM CAN 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.015 gms 12.5 gms 0.256 gms Flu솗casone Propionate 250mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 63 mcl Aerosol vale 14ml ALUMINIUM CAN COVERS /CAPS 0.03 gms 12.5 gms
5 6 (HFA 134A Propellant) ETHANOL 0.256 gms Formoterol Fumarate Inhaler 12mcg (120MD) with 40mcl Aerosol Valve and 10ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 Formoterol Fumarate 40 mcl AEROSOL VALVES 10ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.0014 gms 7.84 gms 0.16 gms Formoterol Fumarate and Budesonide Inhaler 100/6mcg (120MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 BUDESONIDE Formoterol Fumarate 19ml ALUMINIUM CAN 0.012 gms 0.0007 gms As per packing policy As per packing policy
5 6 COVERS /CAPS (HFA 134A Propellant) As per packing policy 12.2 gms Formoterol Fumarate and Budesonide Inhaler 200/6mcg (120MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 BUDESONIDE Formoterol Fumarate 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) Ethanol 0.0007 gms 0.024 gms As per packing policy As per packing policy As per packing policy 12.2 gms Nil The above norms are applicable subject to the condition that: Import of HFA 134 A Propellant and its quantity is subject to NOC from Ministry of Environment and Forests. Requirement of HFA 134 A Propellant is inclusive of allowances for permissible loss in weight on storage and primary losses. The firm will maintain separate record on HFA 134 A Propellant import and consumption 179
Case No.:16/32/82ALC4/2011
Party Name:AUCTUS PHARMA LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/00897/AM12/ RLA File :09/24/040/00257/AM12/ Lic.No/Date:0910048616 06.09.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to
180
Case No.:28/28/82ALC4/2011
Party Name:DHANUKA LABORATORIES LTD. 31.01.2012 Status:Case Deferred HQ File :01/82/050/00798/AM12/ RLA File :05/23/040/00214/AM12/ Lic.No/Date:0510301712 08.09.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 181
Case No.:6/32/82ALC4/2011
31.01.2012 Status:Case Deferred HQ File :01/82/050/00887/AM12/ RLA File :09/24/040/00277/AM12/ Lic.No/Date:0910048658 08.09.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 182
Case No.:15/32/82ALC4/2011
Party Name:RAMPEX LABS PVT. LTD. 31.01.2012 Status:Case Deferred HQ File :01/82/050/00896/AM12/ RLA File :09/24/040/00273/AM12/ Lic.No/Date:0910048689 09.09.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 183
Case No.:19/32/82ALC4/2011
Party Name:MATRIX LABORATORIES LIMITED Meet No/Date:44/82ALC4/2011 31.01.2012 Status:Case Deferred HQ File :01/82/050/00900/AM12/ RLA File :09/24/040/00268/AM12/ Lic.No/Date:0910048699 09.09.2011 Defer Date: 28.2.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 184
Case No.:28/32/82ALC4/2011
Party Name:RAMPEX LABS PVT. LTD. 31.01.2012 Status:Case Deferred HQ File :01/82/050/00909/AM12/ RLA File :09/24/040/00272/AM12/ Lic.No/Date:0910048688 09.09.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to
Case No.:5/32/82ALC4/2011
185 y 31.01.2012 Status:Case Deferred HQ File :01/82/050/00886/AM12/ RLA File :09/24/040/00275/AM12/ Lic.No/Date:0910048753 13.09.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 186 Case No.:9/29/82ALC4/2011 31.01.2012 Status:Case Approved HQ File :01/82/050/00808/AM12/ RLA File :03/94/040/00519/AM12/ Lic.No/Date:0310653828 15.09.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to ratify the norms under Para 4.7 of HBP v1 as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed in Kgs Triomune Junior Tablets/Lamivudine, Stavudine and Nevirapine Tablets Each uncoated tablet contains: Stavudine 12 mg, Lamivudine 60 mg, Nevirapine 100 mg 1 million tablet 1. 2 3 Lamivudine Nevirapine 2,3‐Didehydro,5‐O‐benzoyl, 5‐methyl uridine (Z‐4 Compound) 61.2 kg 102.0 kg 24.48 kg Lamivir S‐30 Tablets/Lamivudine and Stavudine Tablets Each film coated tablet contains: Lamivudine 150 mg Stavudine 30 mg 1 million tablet 1. 2 3 Lamivudine Nevirapine 153.0 kg ‐ 61.2 g Triomune 30/Lamivudine, Stavudine and Nevirapine Tablets. Each uncoated tablet contain: Stavudine 30 mg, Lamivudine 150 mg, Nevirapine 200 mg 1 million tablet 1. 2 3 Lamivudine Nevirapine 153.0 kg 204.0 kg 61.2 kg Triomune Baby Tablets/Triomune Baby Dispersible 1 million tablet 1. 2 Lamivudine Nevirapine 30.6 kg 51.0 kg
Tablets/Lamivudine, Stavudine and Nevirapine Tablets. Each uncoated tablet contains: Stavudine 6 mg Lamivudine 30 mg, Nevirapine 50 mg 3 12.24 kg Lamivir‐S Junior Tablets/Lamivudine, Stavudine Dispersible Tablets Each Tablet contains: Lamivudine 60 mg, Stavudine 12 mg 1 million tablet 1. 2 3 Lamivudine Nevirapine 61.2 kg ‐ 24.48 kg Lamivir‐S Baby Tablets/Lamivudine, Stavudine Dispersible Tables Each tablet contains: Lamivudine 30 mg, Stavudine 6 mg 1 million tablet 1. 2 3 Lamivudine Nevirapine 30.6 kg ‐ 12.24 kg 187 Case No.:10/29/82ALC4/2011 31.01.2012 Status:Case Approved HQ File :01/82/050/00809/AM12/ RLA File :03/94/040/00526/AM12/ Lic.No/Date:0310653874 15.09.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to ratify the norms under Para 4.7 of HBP v1 as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Triomune Junior Tablets/Lamivudine, Stavudine and Nevirapine Tablets Each uncoated tablet contains: Stavudine 12 mg, Lamivudine 60 mg, Nevirapine 100 mg 1 million tablet 1. 2 3 Lamivudine Nevirapine 61.2 kg 102.0 kg 24.48 kg 1 million 1. Lamivudine 153.0 kg
Lamivir S‐30 Tablets/Lamivudine and Stavudine Tablets Each film coated tablet contains: Lamivudine 150 mg Stavudine 30 mg tablet 2 3 Nevirapine ‐ 61.2 kg Triomune 30/Lamivudine, Stavudine and Nevirapine Tablets. Each uncoated tablet contain: Stavudine 30 mg, Lamivudine 150 mg, Nevirapine 200 mg 1 million tablet 1. 2 3 Lamivudine Nevirapine 153.0 kg 204.0 kg 61.2 kg Triomune Baby Tablets/Triomune Baby Dispersible Tablets/Lamivudine, Stavudine and Nevirapine Tablets. Each uncoated tablet contains: Stavudine 6 mg Lamivudine 30 mg, Nevirapine 50 mg 1 million tablet 1. 2 3 Lamivudine Nevirapine 30.6 kg 51.0 kg 12.24 kg Lamivir‐S Junior Tablets/Lamivudine, Stavudine Dispersible Tablets Each Tablet contains: Lamivudine 60 mg, Stavudine 12 mg 1 million tablet 1. 2 3 Lamivudine Nevirapine 61.2 kg ‐ 24.48 kg Lamivir‐S Baby Tablets/Lamivudine, Stavudine Dispersible Tables Each tablet contains: Lamivudine 30 mg, Stavudine 6 mg 1 million tablet 1. 2 3 Lamivudine Nevirapine 30.6 kg ‐ 12.24 kg
188 Case No.:8/32/82ALC4/2011 Party Name:PORUS LABORATORIES PVT LTD. 31.01.2012 Status:Case Deferred HQ File :01/82/050/00889/AM12/ RLA File :09/24/040/00264/AM12/ Lic.No/Date:0910048808 15.09.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in light of written comments forwarded by Department of Chemicals and Petrochemicals forwarded vide their letter No. 46011/106/2011PC II dated 3.1.2011 decided to call from the firm the following details: 1. Technical specifications, specific chemical name, % composition (by weight) and product catalogue of export product i.e. MX 9000 along with specific end use/application and the copy of export order 2. Technical specifications, specific chemical names, % composition (by weight), product catalogue of import product i.e. MX 90/SA 90 and the copy of proforma invoice 3. Details and quantity of other indigenous inputs to be used in the manufacture of the export product 4. Detailed manufacturing process along with justification for wastages at each stage and also on each of the raw material. 5. Complete material balance indicating input and output material at each state of manufacturing process. 6. Authentic/standard technical literature in support of the requirement of raw material for the export product under reference. 7. Details of production of export product under reference and corresponding consumption of raw material in the year 200910 and 2010 11 duly certified by CA and if the production has not commenced in the past, the details from commencement of production to be certified by CA. 189
Case No.:7/29/82ALC4/2011
Party Name:MEDICAMEN BIOTECH LTD., 31.01.2012 Status:Case Deferred HQ File :01/82/050/00806/AM12/ RLA File :05/24/040/00208/AM12/ Lic.No/Date:0510302892 19.09.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 190 Case No.:6/29/82ALC4/2011 Party Name:RANBAXY LABORATORIES LTD 31.01.2012 Status:Case Deferred HQ File :01/82/050/00805/AM12/ RLA File :05/24/040/00198/AM12/ Lic.No/Date:0510303163 20.09.2011 Defer Date:28.02.2012
Decision : Committee considered case as per agenda and in light of earlier decision taken in 25/82 meeting held on 20.09.2011 and in consultation with technical authorities present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Isotretinoin 1 Kg. 1. Acetone 0.48 kg 2. Activated Carbon 0.100 kg 3. Beta Ionone 3.20 kg 4. Dimethyl Acrylic Acid 2.37 kg 5 Lithium Aluminium Hybride 0.40 kg 6 Methanol 8.56 kg 7. Methylene Chloride 9.36 kg 8. N Butyl Lithium 30% 0.89 kg 9. Tetrahydrofuran 6.59 kg 10. Toluene 7.53 kg 11 Triethylphosphone Acetate 4.10 kg RA concerned may take further necessary action as per above decision of NC 191
Case No.:8/36/82ALC4/2011
Party Name:RANBAXY LABORATORIES LTD 31.01.2012 Status:Case Approved HQ File :01/82/050/00965/AM12/ RLA File :05/24/040/00205/AM12/ Lic.No/Date:0510303164 20.09.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in 25/82 meeting held on 20.09.2011 and in consultation with technical authorities present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Isotretinoin 1 Kg. 1. Acetone 0.48 kg 2. Activated Carbon 0.100 kg 3. Beta Ionone 3.20 kg 4. Dimethyl Acrylic Acid 2.37 kg 5 Lithium Aluminium Hybride 0.40 kg 6. Methanol 8.56 kg 7. Methylene Chloride 9.36 kg 8. N Butyl Lithium 30% 0.89 kg 9. Tetrahydrofuran 6.59 kg 10 Toluene 7.53 kg 11. Triethylphosphone Acetate 4.10 kg RA concerned may take further necessary action as per above decision of NC.
192 Case No.:12/29/82ALC4/2011 Party Name:GLENMARK GENERICS LIMITED 31.01.2012 Status:Case Approved HQ File :01/82/050/00811/AM12/ RLA File :03/94/040/00530/AM12/ Lic.No/Date:0310655109 21.09.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 193
Case No.:22/32/82ALC4/2011
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 31.01.2012 Status:Case Deferred HQ File :01/82/050/00903/AM12/ RLA File :04/24/040/00155/AM12/ Lic.No/Date:0410128356 21.09.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 194
Case No.:23/32/82ALC4/2011
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 31.01.2012 Status:Case Deferred HQ File :01/82/050/00904/AM12/ RLA File :04/24/040/00153/AM12/ Lic.No/Date:0410128355 21.09.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 195
Case No.:24/32/82ALC4/2011
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 31.01.2012 Status:Case Deferred HQ File :01/82/050/00905/AM12/ RLA File :04/24/040/00154/AM12/ Lic.No/Date:0410128434 22.09.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 196
Case No.:39/32/82ALC4/2011
Party Name:NECTAR LIFESCIENCES LIMITED, 31.01.2012 Status:Case Deferred HQ File :01/82/050/00920/AM12/ RLA File :22/24/040/00046/AM12/ Lic.No/Date:2210011928 22.09.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 197 Case No.:27/32/82ALC4/2011 Party Name:FORACE POLYMERS (P) LTD. 31.01.2012 Status:Case Deferred
HQ File :01/82/050/00908/AM12/ RLA File :05/23/040/00235/AM12/ Lic.No/Date:0510303607 23.09.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 198
Case No.:18/32/82ALC4/2011
Party Name:ENVEE DRUGS PVT LTD 31.01.2012 Status:Case Approved HQ File :01/82/050/00899/AM12/ RLA File :34/24/040/00123/AM12/ Lic.No/Date:3410031758 28.09.2011 Defer Date: Decision : Committee considered case as per agenda for ratification of norms and in light of written earlier decision taken in Meeting No. 17/82 dated 22.7.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Clobetasol Propionate 1 Kg. 1. Betamethasone BP 1.04 kg/kg 199
Case No.:26/32/82ALC4/2011
Party Name:MEDICAMEN BIOTECH LTD., 31.01.2012 Status:Case Deferred HQ File :01/82/050/00907/AM12/ RLA File :05/24/040/00219/AM12/ Lic.No/Date:0510304120 28.09.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 200
Case No.:18/36/82ALC4/2011
Party Name:MEDREICH LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/00975/AM12/ RLA File :07/24/040/00178/AM12/ Lic.No/Date:0710082847 28.09.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 201 Case No.:25/32/82ALC4/2011 Party Name:RANBAXY LABORATORIES LTD 31.01.2012 Status:Case Deferred HQ File :01/82/050/00906/AM12/ RLA File :05/24/040/00194/AM12/ Lic.No/Date:0510304240 29.09.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to
202
Case No.:5/36/82ALC4/2011
Party Name:MICRO LABS LTD 31.01.2012 Status:Case Deferred HQ File :01/82/050/00962/AM12/ RLA File :07/24/040/00219/AM12/ Lic.No/Date:0710082912 29.09.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 203
Case No.:1/29/82ALC4/2011
Party Name:SANDOZ PRIVATE LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/00800/AM12/ RLA File :03/95/040/00325/AM12/ Lic.No/Date:0310657295 30.09.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 204
Case No.:10/32/82ALC4/2011
Party Name:DHANUKA LABORATORIES LTD. 31.01.2012 Status:Case Deferred HQ File :01/82/050/00891/AM12/ RLA File :05/23/040/00244/AM12/ Lic.No/Date:0510304494 03.10.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 205
Case No.:12/32/82ALC4/2011
Party Name:AMI LIFESCIENCES P LTD 31.01.2012 Status:Case Deferred HQ File :01/82/050/00893/AM12/ RLA File :34/24/040/00137/AM12/ Lic.No/Date:3410031901 12.10.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 206
Case No.:5/31/82ALC4/2011
Party Name:TITAN LABORATORIES PVT. LTD. 31.01.2012 Status:Case Deferred HQ File :01/82/050/00831/AM12/ RLA File :03/95/040/00570/AM12/ Lic.No/Date:0310659395 13.10.2011 Defer Date:28.02.2012 Decision : Committee considered the case as per agenda in consultation with the technical authority present in the meeting decided to remind the firm to furnish Master Batch Forumula certified by Quality Control Incharge. Accordingly, the case has been deferred for 28.2.2012.
207
Case No.:12/36/82ALC4/2011
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 31.01.2012 Status:Case Approved HQ File :01/82/050/00969/AM12/ RLA File :07/24/040/00275/AM12/ Lic.No/Date:0710083317 18.10.2011 Defer Date: Decision : Committee considered case as per agenda and in the light of earlier decision taken in meeting No. 44 dated 1.2.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Ceftazidime for Injection USP 1 gm Vial Size:20 ml 1Vial 1. Ceftazimide USP (As Ceftazidime Pentahydrate) (As Blend of Sterile Ceftazidime Pentahydrate & Sterile Sodium Carbonate) USP 1.13 gram RA concerned may take further necessary action as per above decision of NC. 208
Case No.:19/36/82ALC4/2011
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 31.01.2012 Status:Case Deferredd HQ File :01/82/050/00976/AM12/ RLA File :07/24/040/00274/AM12/ Lic.No/Date:0710083319 18.10.2011 Defer Date 28.2.2012: Decision The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to . 209 Case No.:23/36/82ALC4/2011 Party Name:SIDDHI VINAYAKA SPECHEM PVT.LTD., 31.01.2012 Status:Case Deferred HQ File :01/82/050/00980/AM12/ RLA File :07/24/040/00284/AM12/ Lic.No/Date:0710083443 21.10.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in the light of written comments forwarded by Department of Chemicals and Petrochemicals vide their letter NO. 14010/154/2011Ch. II dated 2.1.2012 and consultation with the technical authorities present in the meeting decided to call from the firm the following information: Balanced chemical reaction showing all the reactants, product and by product with their molecular formula and molecular weight. Complete material balance with the formation of isomers.
Stagewise % yield on molecular weight basis alongwith justification supported with authentic/printed technical literature. Prodcution of export item for the year 201011 and corresponding consumption of each input duly certified by CA. Photocopy of earlier norms fixed by DGFT in the past for same export item. Accordingly, the case has been deferred for 28.2.2012. 210
Case No.:2/32/82ALC4/2011
Party Name:RUSAN PHARMA LTD. 31.01.2012 Status:Case Deferred HQ File :01/82/050/00883/AM12/ RLA File :03/95/040/00615/AM12/ Lic.No/Date:0310662064 25.10.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 211
Case No.:24/36/82ALC4/2011
Party Name:MEDREICH LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/00981/AM12/ RLA File :07/24/040/00305/AM12/ Lic.No/Date:0710083785 08.11.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 212
Case No.:6/36/82ALC4/2011
Party Name:AUROLAB 31.01.2012 Status:Case Deferred HQ File :01/82/050/00963/AM12/ RLA File :35/24/040/00027/AM12/ Lic.No/Date:3510036087 11.11.2011 Defer Date:28.02.2012 Decision : Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to call from the firm the Drug Manufacturing License duly certified by Quality control incharge. Accordingly, the case has been deferred for 28.2.2012. 213
Case No.:2/36/82ALC4/2011
Party Name:EMCURE PHARMACEUTICALS LTD. 31.01.2012 Status:Case Deferred HQ File :01/82/050/00959/AM12/ RLA File :31/83/040/00170/AM12/ Lic.No/Date:3110051562 21.11.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 214 Case No.:1/37/82ALC4/2011 Party Name:THERMAX LTD., 31.01.2012 Status:Case Deferred
HQ File :01/82/050/00983/AM12/ RLA File :31/83/040/00157/AM12/ Lic.No/Date:3110051627 28.11.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 215
Case No.:2/37/82ALC4/2011
Party Name:POLYDRUG LABORATORIES PVT.LTD. 31.01.2012 Status:Case Deferred HQ File :01/82/050/00984/AM12/ RLA File :03/95/040/00667/AM12/ Lic.No/Date:0310667832 29.11.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 216
Case No.:3/37/82ALC4/2011
Party Name:RELIANCE LIFE SCIENCES PVT. LTD. 31.01.2012 Status:Case Deferred HQ File :01/82/050/00985/AM12/ RLA File :03/95/040/00538/AM12/ Lic.No/Date:0310668193 30.11.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 217
Case No.:3/44/82ALC4/2011
Party Name:DALAS BIOTECH LTD. 31.01.2012 Status:Case Approved HQ File :01/82/050/01175/AM12/ RLA File :05/23/040/00344/AM12/ Lic.No/Date:0510311321 15.12.2011 Defer Date: Decision : Committee considered the case as per agenda and in light of the written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/262/2009PI(Norms) dated 8.3.2010 and in consultation with the technical authority present in meeting, decided to ratify norms under Para 4.7 of HBP v 1 as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed 7AVCA 1 Kg 1 2 3 7Phenylacetamideo3Chloromethyl Cephalosporanic Acid Para Methoxybenzyl Ester (GCLE) Tri Phenyl Phospine Methylene Chloride 2.672 kg 1.260 Kg 5.488 kg
218
Case No.:5/44/82ALC4/2011
31.01.2012 Status:Case Deferred HQ File :01/82/050/01177/AM12/ RLA File :05/23/040/00349/AM12/ Lic.No/Date:0510311823 20.12.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 219
Case No.:1/40/82ALC4/2011
Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. 31.01.2012 Status:Case Deferred HQ File :01/82/050/00997/AM12/ RLA File :31/83/040/00191/AM12/ Lic.No/Date:3110051996 20.12.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 220
Case No.:2/40/82ALC4/2011
Party Name:FDC LTD 31.01.2012 Status:Case Deferred HQ File :01/82/050/00998/AM12/ RLA File :03/94/040/00819/AM12/ Lic.No/Date:0310671854 20.12.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 221
Case No.:4/40/82ALC4/2011
Party Name:DEEPAK NITRITE LIMITED 31.01.2012 Status:Case Deferred HQ File :01/82/050/01000/AM12/ RLA File :31/83/040/00137/AM12/ Lic.No/Date:3110052056 22.12.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to 222 Case No.:5/40/82ALC4/2011 Party Name:DEEPAK NITRITE LIMITED 31.01.2012 Status:Case Approved HQ File :01/82/050/01001/AM12/ RLA File :31/83/040/00174/AM12/ Lic.No/Date:3110052057 22.12.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written decision taken in meeting no. 28/82 held on 11.10.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed 2Ethyl Hexyl Nitrate 1 Kg. 1. 2Ethyl Hexanol 0.765 kg
RA concerned may take further necessary action as per above decision of NC. 223
Case No.:2/44/82ALC4/2011
Party Name:DHANUKA LABORATORIES LTD. 31.01.2012 Status:Case Deferred HQ File :01/82/050/01174/AM12/ RLA File :05/23/040/00346/AM12/ Lic.No/Date:0510312327 26.12.2011 Defer 28.2.2012Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to call from the firm the complete chemical description of their export product. Accordingly, the case has been deferred for 28.2.2012. 224
Case No.:4/44/82ALC4/2011
Party Name:DHANUKA LABORATORIES LTD. 31.01.2012 Status:Case Deferred HQ File :01/82/050/01176/AM12/ RLA File :05/23/040/00365/AM12/ Lic.No/Date:0510312325 26.12.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to call from the firm the complete chemical description of their export product. Accordingly, the case has been deferred for 28.2.2012. 225
Case No.:1/44/82ALC4/2011
Party Name:EMCURE PHARMACEUTICALS LTD. 31.01.2012 Status:Case Deferred HQ File :01/82/050/01173/AM12/ RLA File :31/83/040/00213/AM12/ Lic.No/Date:3110052544 20.01.2012 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authority present in the meeting decided to Date:02.02.2012 Place:New Delhi Lalita Maini Foreign Trade Development Officer
Verbatim extracted text (OCR/PDF). Older scans and tables may show extraction artifacts — verify against the original for anything you act on.
No analysis has been generated for this document yet.