DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi 0
Para 4.7 Decision
MEETING NUMBER : 30/82ALC4/2010 MEETING DATE : 26.10.2010 The Meeting No.30/82 in the year 201011 to consider the cases under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to products falling in Chapter 29 and 30 was held on 26.10.2010 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present: 1. Shri Shaish Kumar, IA, DIPP 2. Shri Jasbir Singh, IA, Department of C&PC 3. Shri DN Mathur,DY.I.A.,Department of Pharmaceuticals 4. Shri Krishan Kumar, Dy. DGFT 5. Shri Shyam Lal, FTDO Manual Cases
Case No. B251
M/s Deepak Nitrite Ltd. N C Meeting No. 30/11 F.No.01/162/50/01601/AM09/DESIII Meeting Date 26.10.2010 Decision: On the recommendations of representative from D/O C&PC, it was decided to call for following information from the firm: (i)Process details with Chemical equation; (ii) Malecular formula & yields & (iii) Production & Consumption data duly certified by Jurisdictional Central Excise Authority. The case was deferred for 21.12.10.
Case No. B252
M/s Porus Laboratories Pvt. Ltd. N C Meeting No. 30/11 F.No.01/82/50/00322/AM10/DESIII F.No.01/82/50/00035/AM11/DESIII Meeting Date 26.10.2010 RLA F.No.09/24/040/00118/AM10 RLA F.No.09/24/040/00529/AM10 Adv. Lic. No. 0910038561 dt. 13.07.09 Adv. Lic. No. 0910041750 dt. 21.04.10 Decision: The Committee considered the agenda placed before it. From the firm, Dr. S.C.Chaturvedi, Dy. General MangerR&D appeared for PH. After hearing Dr.Chaturvedi, on the recommendation of TAs present in the meeting NC decided to maintain statusquo, as the earlier recommendations of NC were based on technical information furnished by the firm.
Case No. B253
M/s Vivimed Labs Ltd. Ltd. N C Meeting No. 30/11 F.No.01/82/50/00236/AM10/DESIII Meeting Date 26.10.2010 RLA F.No.09/24/040/00504/AM10 Adv. Lic. No. 0910041262 dt. 11.03.10 Decision : The case was deferred for comments of C&PC for 23.11.10
Case No. B254
M/s Hetro Labs. Ltd. N C Meeting No. 30/11 F.No.01/82/50/01100/AM08/DESIII Meeting Date 26.10.2010 RLA F.No.09/24/040/00227/08 Adv. Lic. No0910031385 dated 03.09.07 Decision:The Committee decided to defer the case for 21.12.10.
Case No. B255
M/s Pab Orgainics Pvt. Ltd. N C Meeting No. 30/11 F.No.01/82/50/01042/AM10/DESIII F.No.01/82/50/01119/AM10/DESIII Meeting Date 26.10.2010 RLA F.No.34/24/040/00154/AM10 RLA F.No.34/24/040/00153/AM10 Adv. Lic. No. 3410025955 dt. 22.12.09 Adv. Lic. No. 3410025954 dt. 22.12.09 Decision: It was decided to forward a copy of application to D/o Pharmaceuticals and to defer the case for 21.12.2010.
Case No. B256
M/s Span Diagnostics Ltd. N C Meeting No. 30/11 F.No.01/82/50/01536/AM09/DESIII Meeting Date 26.10.2010 RLA F.No.52/24/040/00028/AM09 Adv. Lic. No. 5210025186 dt. 12.01.09 Decision:The Committee considered the case as per agenda and in view of D/o BioTechnology OM No.BT/IL/05/308/2009PID dt.20.6.10 and in consultation with TAs present meeting decide to ratify adhoc norms as under or as applied by the firm whichever is lower: Export Product Export Qty. Sl.No. Import items Qty. allowed Parahitf (Device) Test Kit (50 tests per Kit) 56000 Nos. 1. Brij35(NonIonic Detergent ) 1000 gm. 2. Gold Chloride 6.791 litre 3. Triton X100 (NonIonic Detergent ) 27.733 gm. 4. Anti Mouse 1 gG (Goat) 2500 gm. 5. Bovine Albumin Powder Standard 666.670 gm. 6. Bovine Albumin Protease Free Powder. 29.0 gm. 7. MAB to P. Falciparum for NCM 28.833 gm. 8. MAB for P. Falciparum Colloidal Gold Rea 40000 Nos. 9. Absorbent Pad 30 MM x 500 Ft. 40000 Nos. 10. Conjugate Releasing Pad (2040/2033) Parahit 2800000 Nos. 11. Disposable lancets pack each contain25 112000 Nos.
Heparinized Capallaries pack cont25 112000 Nos. 13. Disposable Swab pack each contain25 112000 Nos. 14. Arrow sign printed self adhesive tape size 91.670 gm. Decision taken in Meeting No.17/11 dt.21.07.09 withdrawn .RA may take action accordingly.
Case No. B257
M/s Harman Finochem Ltd. N C Meeting No. 30/11 F.No. 01/82/50/00155 /AM07/DESIII F.No. 01/82/50/01768 /AM07/DESIII F.No. 01/82/50/00103 /AM08/DESIII F.No. 01/82/50/00181 /AM08/DESIII FNo. 01/82/50/00014 /AM08/DESIII Meeting Date 26.10.2010 Adv.Lic.No.0310378665 dated 02.05.2006 Adv.Lic.No. 0310422394 dated 08.03.2007 Adv.Lic.No.0310431949 dated 07.06.2007 Adv.Lic.No.0310443468 dated 18.09.2007 Adv.Lic.No.0310433397 dated 21.06.2007 Decision : The Committee considered the case as per agenda and on the written comments furnished by Representative of D/o pharmaceuticals decided to revise ad –hoc norms as under or as applied by the firm whichever is lower : Export Product Export Qty. Sl.No. Import items Qty. allowed Phenobarbital 1 kg 1. Benzyl Cynaide 0.662 kg 2. Dimethyl Carbonate 0.59 kg 3. Methanol 0.6935 kg 4. Sodium Methoxide Powder 0.66 kg Earlier NC’s decision taken in meeting No. 12/82 dated 10.04.2006 is withdrawn. RA may take action accordingly. On Line Cases 1
Case No.:3/32/82ALC4/2008
Party Name:D.TOTLA PLASTIC Meet No/Date:30/82ALC4/2010 26.10.2010 Status:Case Deferred HQ File :01/82/050/01178/AM09/ RLA File :03/94/040/00710/AM09/ Lic.No/Date:0310491145 20.10.2008 Defer Date:07.12.2010
Decision :It was decided to remind PC Division of D/o C&PC for coments and to defer the case for07.12.2010. 2
Case No.:13/10/82ALC4/2009
Party Name:VASUDHA PHARMA CHEM LTD 26.10.2010 Status:Case Approved HQ File :01/82/050/00137/AM10/ RLA File :09/24/040/00055/AM10/ Lic.No/Date:0910038020 28.05.2009 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O.No.14010/77/2010 Ch.II dated 11.10.2010 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 Export Qty. Sl.No. Import items Qty. allowed Methyl1,3,4 Trimethyl1H Pyrazole5Carboxylate 1 kg 1. Dimethyl Oxalate 1.402 kg 2. Methanol 1.000 kg 3. Sodium Methoxide 0.642 kg 4. Hydrazine Hydrate 0.516 kg 5. Paraformaldehyde 0.238 kg Other import items are not recommended. RA concerned may take further necessary action as per above decision of NC. 3
Case No.:4/19/82ALC4/2009
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 26.10.2010 Status:Case Deferred HQ File :01/82/050/00382/AM10/ RLA File :03/94/040/00307/AM10/ Lic.No/Date:0310531016 28.07.2009 Defer Date:23.11.2010 Decision : The Committee decided to defer the case for comments of D/o C&PC for 23.11.2010. 4
Case No.:19/24/82ALC4/2009
Party Name:PANACEA BIOTEC LTD., 26.10.2010 Status:Case Rejected HQ File :01/82/050/00516/AM10/ RLA File :05/24/040/00299/AM10/ Lic.No/Date:0510248628 28.08.2009 Defer Date: Decision : The Committee decided to reject the case, as the information sought vide this Directorate’s letter dated 20.6.10 has not so far been made available by the firm. 5
Case No.:21/24/82ALC4/2009
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 26.10.2010 Status:Case rejected HQ File :01/82/050/00518/AM10/ RLA File :03/95/040/00331/AM10/ Lic.No/Date:0310535917 31.08.2009 Defer Date: Decision : The Committee decided to reject the case, as the firm did not furnish Central Excise Certified production & Consumption data sought for vide letter dated 16.9.2010.
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Case No.:27/24/82ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 26.10.2010 Status:Case Deferred HQ File :01/82/050/00524/AM10/ RLA File :09/24/040/00196/AM10/ Lic.No/Date:0910039221 01.09.2009 Defer Date:23.11.2010 Decision : The Committee decided to defer the case for 23.11.10 for comments of D/o Pharmaceuticals. 7
Case No.:28/24/82ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 26.10.2010 Status:Case Deferred HQ File :01/82/050/00525/AM10/ RLA File :09/24/040/00199/AM10/ Lic.No/Date:0910039222 01.09.2009 Defer Date:23.11.2010 Decision : The Committee decided to defer the case for 23.11.10 for comments of D/o Pharmaceuticals. 8
Case No.:29/24/82ALC4/2009
Party Name:VIVIN LABORATORIES PRIVATE LIMITED 26.10.2010 Status:Case Approved HQ File :01/82/050/00526/AM10/ RLA File :09/24/040/00208/AM10/ Lic.No/Date:0910039223 01.09.2009 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M.No.35011/65/2010PI (Norms) dated 01.10.2010 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 Export Qty. Sl.No. Import items Qty. allowed (2R,5R)5Hydroxy(1,3) Oxathiolane2Carboxylic Acid,2S ISOPROPYL5R methylIR Cyclohexylester. 1 kg 1. Glyoxalic Acid 50% 0.717 kg 2. 2,5 Di Hydroxy 1,4 Di Thiane 0.30 Kg 3. NHexane 1.10 Kg 4. Cyclohexane 1.48 Kg 5. Toluene 0.67 Kg 9
Case No.:2/26/82ALC4/2009
Party Name: VIVIMED LABS LIMITED 26.10.2010 Status:Case Approved HQ File :01/82/050/00534/AM10/ RLA File :09/24/040/00185/AM10/ Lic.No/Date:0910039258 09.09.2009 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M.No.14010/68/2010/Ch.II 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 Export Qty. Sl.No. Import items Qty. allowed N, NBis (2 Hydroxyethyl)P Phenylendiamine Sulfate Monohydrate/BHP 1 kg 1. 2. N.N.Bis(2Hydroxy Ethyl Aniline) Sodium Nitrite 1.10 kg 0.430 kg
y RA concerned may take further necessary action as per above decision of NC 10
Case No.:9/28/82ALC4/2009
Party Name:EMCURE PHARMACEUTICALS LTD. 26.10.2010 Status:Case Approved HQ File :01/82/050/00569/AM10/ RLA File :31/24/040/00110/AM10/ Lic.No/Date:3110040034 23.09.2009 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M.No.35011/9 5/2010PI (Norms) dated 01.10.2010 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 Export Qty. Sl.No. Import items Qty. allowed Sevelamer Hydrocloride 1 kg 1. Polyallylamine Hydrochloride Chemical (Assay by titration between 48% W/W and 52% W/W 2.7 kg 11
Case No.:3/30/82ALC4/2009
Party Name:VIVIMED LABS LIMITED 26.10.2010 Status:Case Approved HQ File :01/82/050/00604/AM10/ RLA File :09/24/040/00260/AM10/ Lic.No/Date:0910039512 08.10.2009 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M.No.14010/68/2010/Ch.II/ 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 Export Qty. Sl.No. Import items Qty. allowed EHT (Ethyl Hexyl Triazone)/Etone 1 kg 1. 2. 3. 4. 5. 6. 7. Para Nitro Benzoic Acid (PNBA) Perchloro Ethylene (PCE) Methanol 2 Ethyl Hexanol Aceto Nitrile Xylene (Ortho xylene) Cyanuric Chloride 2.510 0.606 3.324 2.150 2.636 1.00 0.64 12
Case No.:9/30/82ALC4/2009
Party Name:EMCURE PHARMACEUTICALS LTD. 26.10.2010 Status:Case Approved HQ File :01/82/050/00610/AM10/ RLA File :31/24/040/00123/AM10/ Lic.No/Date:3110040264 09.10.2009 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M.No.35011/9 5/2010PI (Norms) dated 01.10.2010 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 Export Qty. Sl.No. Import items Qty. allowed Sevelamer Hydrocloride 1 kg 1. Polyallylamine Hydrochloride Chemical (Assay by titration between 48% W/W and 52% W/W 2.7 kg 13
Case No.:15/33/82ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 26.10.2010 Status:Case Deferred HQ File :01/82/050/00643/AM10/ RLA File :09/24/040/00240/AM10/ Lic.No/Date:0910039761 29.10.2009 Defer Date:23.11.2010 Decision : The Committee decided to defer the case for 23.11.10 for comments of D/o Pharmaceuticals 14
Case No.:21/2/82ALC4/2010
Party Name:THERMAX LTD., 26.10.2010 Status:Case Deferred HQ File :01/82/050/01255/AM10/ RLA File :31/24/040/00138/AM10/ Lic.No/Date:3110040580 10.11.2009 Defer Date:21.12.2010 Decision : The Committee decided to forward a copy of application to P.C. Division of D/o C&PC and to defer the case for 21.12.10 15
Case No.:20/2/82ALC4/2010
Party Name:THERMAX LTD., 26.10.2010 Status:Case Approved HQ File :01/82/050/01254/AM10/ RLA File :31/24/040/00139/AM10/ Lic.No/Date:3110040645 13.11.2009 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O.No. 14010/78/2010 Ch.II dated 25.10.2010 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 Export Qty. Sl.No. Import items Qty. allowed (Biocide1(2750) (containing THPS 10% min. and LA 22 Ethylene Oxide 5%) 1 kg. 1. Tetrakis Hydroxymethyl Phosphonium Sulphate 75% 0.133 kg Biocide2 (4020) (Containing Gluteraldehyde 10% min. and Benzalkonium Quaternary 10% min. in water. 1 kg. 1. Myristyl Dimethyl Amine 0.065 kg 2. Gluteraldehyde 0.100 kg 16
Case No.:2/37/82ALC4/2009
Party Name:PADMINI AROMATICS PVT. LTD 26.10.2010 Status:Case Rejected
HQ File :01/82/050/00745/AM10/ RLA File :07/24/040/00294/AM10/ Lic.No/Date:0710068389 19.11.2009 Defer Date: Decision : The Committee decided to reject the case as the firm had not furnished information sought vide DGFT’s letter dated 28.4.10. 17
Case No.:5/37/82ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 26.10.2010 Status:Case Deferred HQ File :01/82/050/00748/AM10/ RLA File :09/24/040/00325/AM10/ Lic.No/Date:0910039975 19.11.2009 Defer Date:23.11.2010 Decision: The Committee decided to defer the case for 23.11.10 for comments of D/o Pharmaceuticals 18
Case No.:6/37/82ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 26.10.2010 Status:Case Deferred HQ File :01/82/050/00749/AM10/ RLA File :09/24/040/00326/AM10/ Lic.No/Date:0910039976 19.11.2009 Defer Date:23.11.2010 19
Case No.:9/40/82ALC4/2009
Party Name:RANBAXY LABORATORIES LTD 26.10.2010 Status:Case Approved HQ File :01/82/050/00824/AM10/ RLA File :05/24/040/00404/AM10/ Lic.No/Date:0510254651 16.12.2009 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M.No.35011/99/2010PI (Norms) dated 11.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export Product Export Qty. Sl.No. Import items Qty. allowed Ortistat 1 kg. 1. (S)()2,2bis(diphenylphosphino)1,1 Binaphthyl 0.0166 kg 2. 2 Methoxy Propene 13.10 kg 3. Acetone 0.95 kg 4. Activated Carbon 0.100 kg 5. Diicyclohexyl carbodiimide 1.189 kg 6. Diisobutyl Aluminium hydride 10.76 kg 7. Dimethyl Formamide 0.194 kg 8. Ethyl Acetate 0.40 kg
y g 9. Formic Acid 0.643 kg 10 Lithium Hexamethyldisilazide 2.865 kg 11. LLeucine 0.921 kg 12. Meldrum Acid 2.985 kg 13. Methanol 19.70 kg 14. Methylene Chloride 11.08 kg 15. Palladium Spong 0.00618 16. Pivaloyl chloride 0.848 kg 17. Tetrachlorobis(Pcymene) Diruthenium(II) 0.0083 kg 18. Tetrahydrofuran 3.97 kg 19. Toluene 21.305 kg 20. Triiethylamine 0.780 kg 20
Case No.:57/2/82ALC4/2010
Party Name:ALEMBIC LIMITED 26.10.2010 Status:Case Approved HQ File :01/82/050/01291/AM10/ RLA File :34/24/040/00169/AM10/ Lic.No/Date:3410025988 24.12.2009 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/115/2010PI(Norms) dated 11.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export product Exp. Qty. Sl.No. Import items Qty. allowed Clarithromycin Coated Granules (28% to 44%, as per DML) 1 KG 1. Clarithromycin Net Content (as per DML) +1% WASTAGE OR Its raw material as per SION A2263 on prorata basis. 21
Case No.:2/6/82ALC4/2010
Party Name:ALEMBIC LIMITED 26.10.2010 Status:Case Approved HQ File :01/82/050/00149/AM11/ RLA File :34/24/040/00168/AM10/ Lic.No/Date:3410025987 24.12.2009 Defer Date:
Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/115/2010PI(Norms) dated 11.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export product Exp. Qty. Sl.No. Import items Qty. allowed Clarithromycin Coated Granules (28% to 44%, as per DML) 1 KG 1. Clarithromycin Net Content (as per DML) +1% WASTAGE OR Its raw material as per SION A2263 on prorata basis. 22
Case No.:8/6/82ALC4/2010
Party Name:ALEMBIC LIMITED 26.10.2010 Status:Case Approved HQ File :01/82/050/00155/AM11/ RLA File :34/24/040/00167/AM10/ Lic.No/Date:3410025994 29.12.2009 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/115/2010PI(Norms) dated 11.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export product Exp. Qty. Sl.No. Import items Qty. allowed Clarithromycin Coated Granules (28% to 44%, as per DML) 1 KG 1. Clarithromycin Net Content (as per DML) +1% WASTAGE OR Its raw material as per SION A2263 on prorata basis. 23
Case No.:36/2/82ALC4/2010
Party Name:VIVEK PHARMACHEM (INDIA) LTD., 26.10.2010 Status:Case Rejected HQ File :01/82/050/01270/AM10/ RLA File :13/24/040/00025/AM10/ Lic.No/Date:1310030993 31.12.2009 Defer Date: Decision : The Committee decided to reject the case as the firm had not furnished a copy of DML, as asked for vide DGFT’s letter dt.23.7.10 24
Case No.:4/44/82ALC4/2009
Party Name:SARNA CHEMICALS PVT.LTD. 26.10.2010 Status:Case Approved HQ File :01/82/050/00889/AM10/ RLA File :03/95/040/00601/AM10/ Lic.No/Date:0310555001 13.01.2010 Defer Date:
Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O.No.14010/77/2006 Ch.II dated 12.10.2010 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 Export Qty. Sl.No. Import items Qty. allowed 1Bromo4Cyclohexyl Amino Anthraquinone/XAO Base. 1 kg. 1Chloro Anthraquinone 1.000 kg Cyclohexyl Amine 1.390 kg Caustic Soda Flakes 0.145 kg 25
Case No.:8/44/82ALC4/2009
Party Name:EMAMI LIMITED, 26.10.2010 Status:Case Deferred HQ File :01/82/050/00893/AM10/ RLA File :02/24/040/00173/AM10/ Lic.No/Date:0210136503 14.01.2010 Defer Date:21.12.2010 Decision : The Committee decided to remind DC(MSME) again through a DO reminder at the level of Chairman,NC3 for expediting their comments and to defer the case for 21.12.2010. 26
Case No.:63/22/82ALC4/2010
Party Name:INDSWIFT LABORATORIES LTD., 26.10.2010 Status:Case Deferred HQ File :01/82/050/00716/AM11/ RLA File :22/24/040/00046/AM10/ Lic.No/Date:2210009581 14.01.2010 Defer Date:23.11.2010 27
Case No.:3/45/82ALC4/2009
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 26.10.2010 Status:Case Approved HQ File :01/82/050/00898/AM10/ RLA File :05/24/040/00410/AM10/ Lic.No/Date:0510256550 18.01.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M.No.35011/78/2010PI (Norms) dated 01.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export Product Export Qty. Sl.No. Import items Qty. allowed 2(3(S)(3(2(7Chloro2 quinolinyl)Ethenyl) Phenyl)3 Hydroxypropyl)Benzoic Acid Methyl Ester Hydrate (MT7). 1 kg 1. 7Chloroquinaldine 1.22 kg 2. Isophthaldehyde 1.10 kg 3. Methyl2Iodobenzoate 1.074 kg 4. ()Diisopinocampheyl chloroborane in Heptane(60 65% Solution)(active)(UOM KGA) 1.427 kga 5. Toluene 2.668 kg
Tetrahydrofuran 4.84 kg 28
Case No.:2/16/82ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 26.10.2010 Status:Case Approved HQ File :01/82/050/00518/AM11/ RLA File :08/24/040/00260/AM10/ Lic.No/Date:0810085873 20.01.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M.No.35011/108/2010PI (Norms) dated 05.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export Product Export Qty. Sl.No. Import items Qty. allowed in mg for tablet of 12.5 25.0 50.0 mg mg mg Promethazine 12.5 MG Tablet 73.63 Kgs, 25MG Tablet 1240.50 kgs &50 MG tablet 77.00Kgs 1 Tablet 1. Promethazine Hcl USP 12.75 25.50 51.0 2. Hydroxypropyl Cellulose NF 4.0 8.0 16.0 3. Lacotse Monohydrate NF 81.0 162.0 324.0 4. Other items As per packing policy 29
Case No.:71/14/82ALC4/2010
Party Name:RELIABLE DYECHEM PVT. LTD. Meet No/Date:30/82ALC4/2010 26.10.2010 Status:Case Deferred HQ File :01/82/050/00433/AM11/ RLA File :24/24/040/00016/AM10/ Lic.No/Date:2410027269 29.01.2010 Defer Date:23.11.2010 Decision :The Committee noted that reply was received for the firm and therefore decided to defer the case for comments of D/o C&PC for 23.11.10.
30
Case No.:7/48/82ALC4/2009
Party Name:PARABOLIC DRUGS LTD., 26.10.2010 Status:Case Rejected HQ File :01/82/050/01070/AM10/ RLA File :05/24/040/00407/AM10/ Lic.No/Date:0510257661 03.02.2010 Defer Date: Decision : The Committee noted that the firm had not furnished technical details sought for vide DGFT;s letter dated 13.9.10 and therefore decided to reject the case. 31
Case No.:17/48/82ALC4/2009
Party Name:AMOLI ORGANICS PVT. LTD., 26.10.2010 Status:Case Deferred HQ File :01/82/050/01080/AM10/ RLA File :03/94/040/00025/AM10/ Lic.No/Date:0310558999 08.02.2010 Defer Date:23.11.2010 Decision : As per D/o Pharmaceuticals OM No. 35011/97/2010PI (Norms) dated 5.10.10 . the Committee decided to call for following information from the firm and decided to defer the case for 21.12.2010 : 1. Stepwise complete and balanced chemical reaction for each step, Mol. WT. of each reacted& output product alongwith their molar ratio. 2. % yield on molar basis for each step. 3. Material balance for entire process. 4. Requirement & Recovery of solvent of each step. 5. Production & Consumption data of raw material duly certified by Central Excise. 32
Case No.:47/22/82ALC4/2010
Party Name:EMAMI LIMITED, 26.10.2010 Status:Case Approved HQ File :01/82/050/00700/AM11/ RLA File :02/24/040/00223/AM10/ Lic.No/Date:0210137616 08.02.2010 Defer Date: Decision : : Committee considered case as per agenda and in light of decision taken in meeting no.52/09 dated17.03.09 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 Emami Mentho Plus Balm (MPB) (i)MPB(9 ml) – 11648000 pcs (ii)MPB (1.2 ml) – 70500 pcs (iii)MPB (4ml)1250000 pcs. Total:149932 litres 250928.57 kgs. 1. Micro Crystalline Wax 16492.52 kg 2. Paraffin Wax (Hard Paraffin) 23989.11 kg 3. Light Liquid Paraffin 50317.18 kg 4. Methyl Salicylate (Wintergreen Oil) 14993.20 kg 33
Case No.:49/22/82ALC4/2010
Party Name:ASTRIX LABORATORIES LTD., 26.10.2010 Status:Case Deferred HQ File :01/82/050/00702/AM11/ RLA File :09/24/040/00250/AM10/ Lic.No/Date:0910040873 09.02.2010 Defer
Date:23.11.2010 34
Case No.:49/2/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 26.10.2010 Status:Case Approved HQ File :01/82/050/01283/AM10/ RLA File :09/24/040/00474/AM10/ Lic.No/Date:0910041038 22.02.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M.No.35011/121/2010PI (Norms) dated 11.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export Product Export Qty. Sl.No. Import items Qty. allowed Mirtazapine 1 kg 1. 1Methyl3Phenyl Piperazine 1.446 kg 2. 2Chloro Nicotino Nitrile 1.290 kg 3. Carbon (Activated Carbon) 0.070 kg 4. Cyclohexane 2.434 kg 5. DI ISOpropyl Ether 1.600 kg 6. Dimethyl Formamide 2.156 kg 7. Uthhium Aluminium Hydride 0.203 kg 8. Methylene Chloride 4.071 kg 9. Methanol 1.370 kg 10. Tetrahydrofuran 2.711 kg 35
Case No.:48/2/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 26.10.2010 Status:Case Approved HQ File :01/82/050/01282/AM10/ RLA File :09/24/040/00486/AM10/ Lic.No/Date:0910041063 25.02.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M.No.35011/88/2010PI (Norms) dated 05.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export Product Export Qty. Sl.No. Import items Qty. allowed Paroxetine Hcl Hemihydrate 1 kg 1. Paroxetine carbinol 0.9511 kg 2. 4(Dimethyl amino Pyridine 0.017 kg 3. Activated Carbon) 0.088 kg 4. Cyclohexane 6.827 kg
Methane sulphonyl Chloride 0.580 kg 6. Methanol 1.248 kg 7. Methylene Chloride 4.925 kg 8. Potassium Carbonate (anhydrous) 1.429 kg 9. Sesamol(3,4Methylenedioxyphenol) 0.55 kg 36
Case No.:10/14/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 26.10.2010 Status:Case Approved HQ File :01/82/050/00372/AM11/ RLA File :09/24/040/00507/AM10/ Lic.No/Date:0910041153 03.03.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M.No.35011/88/2010PI (Norms) dated 05.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export Product Export Qty. Sl.No. Import items Qty. allowed Emtricitabine 1 kg 1. 5Fluorocytosine 1.348 kg 2. Glyoxylic acid (as 50%) 2.234 kg 3. Methanesulfonic Acid 0.029 kg 4. Triethyl amine 2..23 kg 5. Triethyl chlorosilane (TMCS) 2.654 kg 6. 2,5Dihydroxy,14Dithiane 0.90 kg 7. Sodium borohydide 0.510 kg 8. Activated Carbon) (Carbon Enoanticromos) 0.100 kg 9. Cyclohexane 1.40 kg 10. Dimethylformamide(DMF) 0.46 kg 11. Methanol 2.44 kg 37
Case No.:11/14/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 26.10.2010 Status:Case Approved HQ File :01/82/050/00373/AM11/ RLA File :09/24/040/00509/AM10/ Lic.No/Date:0910041154 03.03.2010 Defer Date: Decision: : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M.No.35011/88/2010PI (Norms) dated 05.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of
Export Product Export Qty. Sl.No. Import items Qty. allowed Perindopril Tertbutyl Amine 1 kg 1. O H I Acid ((2S,3AS,7AS)OctahydroH Indole2 Carboxylic acid 0.947 kg 2. 4(Dimethylamino)Pyridine 1.247 kg 3. TertButyl amine 0.381 kg 4. Methyl tertButyl Ether 30.66 kg 5. Carbon (Activated Carbon) 0.100 kg 6. LNorvaline 1.423 kg 7. Acetonitrile 13.04 kg 8. Cyclohexane 5.83 kg 38
Case No.:9/6/82ALC4/2010
Party Name:YASHASHVI RASAYAN PVT.LTD 26.10.2010 Status:Case Approved HQ File :01/82/050/00156/AM11/ RLA File :52/24/040/00038/AM10/ Lic.No/Date:5210029879 04.03.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M.No.35011/88/2010PI (Norms) dated 05.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export Product Export Qty. Sl.No. Import items Qty. allowed Chlorhexidine base 1 kg 1. Hexamethylene Diamine 0.3967 kg 2. Sodium dicynamide 0.608 kg 3. Para Nitro Chloro Benene 0.961 kg 4. N. Butanol 2.13 kg 39
Case No.:50/2/82ALC4/2010
Party Name:ARCHIMEDIS LABORATORIES PVT. LTD. 26.10.2010 Status:Case Approved HQ File :01/82/050/01284/AM10/ RLA File :09/24/040/00483/AM10/ Lic.No/Date:0910041210 08.03.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M.No.35011/114/2010PI(norms)/ dated 21.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export Product Export Qty. Sl.No. Import items Qty. allowed CIS[2[2,4Dichlorophenyl] 2[1 H 1 kg 1. 1,2,4Triazole 0.61 kg
[ [ , p y ] [ 1,2,4Triazole1YL Methyl 13 Dioxalan4YL]Methanol g , , g 2. Dimethyl Sulfoxide 1.35 kg 40
Case No.:51/2/82ALC4/2010
Party Name:ARCHIMEDIS LABORATORIES PVT. LTD. 26.10.2010 Status:Case Approved HQ File :01/82/050/01285/AM10/ RLA File :09/24/040/00480/AM10/ Lic.No/Date:0910041209 08.03.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M.No.35011/114/2010PI (Norms) dated 21.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export Product Export Qty. Sl.No. Import items Qty. allowed 2,4Dihydro4[4[(4Hydroxy phenyl)1 Piperazinyl]phenyl]2(1 methyl propyl)3H1,2,4 Trizol3one 1 kg 1. Hydrazine Hydrate 1.443 kg 2. Triethyl Ortho Formate 2.79 kg 3. Dimethyl Formide 4.93 kg 4. Dimethyl Sulfoxide 2.10 kg 5. Chloroform 1.00 kg 41
Case No.:52/2/82ALC4/2010
Party Name:ARCHIMEDIS LABORATORIES PVT. LTD. 26.10.2010 Status:Case Approved HQ File :01/82/050/01286/AM10/ RLA File :09/24/040/00479/AM10/ Lic.No/Date:0910041212 08.03.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M.No.35011/114/2010PI (Norms) dated 21.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export Product Export Qty. Sl.No. Import items Qty. allowed 2,4Dihydro4[4[(4Methoxy phenyl)1 Piperazinyl]phenyl]2(1 methyl propyl)3H1,2,4 Trizol3one 1 kg 1. Hydrazine Hydrate 1.166 kg 2. Triethyl Ortho Formate 2.248 kg 3. Dimethyl Formide 3.95 kg 4. Dimethyl Sulfoxide 1.69 kg 5. Chloroform 0.79 kg 42
Case No.:54/2/82ALC4/2010
Party Name:ARCHIMEDIS LABORATORIES 26.10.2010 Status:Case
PVT. LTD. Approved HQ File :01/82/050/01288/AM10/ RLA File :09/24/040/00484/AM10/ Lic.No/Date:0910041211 08.03.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M.No.35011/114/2010PI(norms)/ dated 21.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export Product Export Qty. Sl.No. Import items Qty. allowed CIS[2[2,4Dichlorophenyl] 2[1 H 1,2,4Triazole1YL Methyl 13 Dioxalan4YL]Methyl Methane Sulfonate 1 kg 1. 1,2,4Triazole 0.576 kg 2. Dimethyl Sulfoxide 1.25 kg 43
Case No.:10/6/82ALC4/2010
Party Name:ALEMBIC LIMITED 26.10.2010 Status:Case Approved HQ File :01/82/050/00157/AM11/ RLA File :34/24/040/00234/AM10/ Lic.No/Date:3410026619 17.03.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/115/2010PI(Norms) dated 11.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export product Exp. Qty. Sl.No. Import items Qty. allowed Clarithromycin Coated Granules (28% to 44%, as per DML) 1 KG 1. Clarithromycin Net Content (as per DML) +1% WASTAGE OR Its raw material as per SION A2263 on prorata basis. 44
Case No.:11/6/82ALC4/2010
Party Name:ALEMBIC LIMITED 26.10.2010 Status:Case Approved HQ File :01/82/050/00158/AM11/ RLA File :34/24/040/00233/AM10/ Lic.No/Date:3410026618 17.03.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/115/2010PI(Norms) dated 11.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export product Exp. Qty. Sl.No. Import items Qty. allowed Clarithromycin Coated Granules (28% to 44%, as per DML) 1 KG 1. Clarithromycin Net Content (as per DML) +1% WASTAGE OR
p ) Its raw material as per SION A2263 on prorata basis. 45
Case No.:65/14/82ALC4/2010
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 26.10.2010 Status:Case Approved HQ File :01/82/050/00427/AM11/ RLA File :03/94/040/01083/AM10/ Lic.No/Date:0310565063 17.03.2010 Defer Date: Decision : : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O.No.14010/9/2005 Ch.II dated 25.10.2010 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 Export Qty. Sl.No. Import items Qty. allowed Astrolide in Diethyl Phthalate/Isopropyl Myristate/Benzyl Benzoate Main Total Astrolide content 62.5% minimum 1 kg 2. Isoamylene 0.380 kg 3. Propylene Oxide 0.280 kg 5. Isopropyl Myristrate 0.350 kg 46
Case No.:6/53/82ALC4/2009
Party Name:HETERO LABS LIMITED 26.10.2010 Status:Case Approved HQ File :01/82/050/01229/AM10/ RLA File :09/24/040/00534/AM10/ Lic.No/Date:0910041332 18.03.2010 Defer Date: Decision: Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M.No.35011/96/2010PI(norms)/ dated 05.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export Product Export Qty. Sl.No. Import items Qty. allowed ATAZANAVIR BISULPHATE 1 kg 1. Tert. Butyl carbazate 0.493 kg 2. (2R,3S)NTBOC3Amino 1,2Epoxy4Phenyl Butane 0.59 kg 3. LTert.Leucine 0.80 kg 4. NEthylN(3Dimethyl Aminopropyl) Carbodiimide Hcl 0.79 kg 5. Acetonitrile 4.04 kg
Tetrahydrofuran 2.44 kg 7. toluene 1.56 kg 8. Isopropyl Aalcohol 4.96 kg 9. Acetone 4.78 kg 10. Methylene Chloride 3.04 kg 47
Case No.:13/6/82ALC4/2010
Party Name:ALEMBIC LIMITED 26.10.2010 Status:Case Approved HQ File :01/82/050/00160/AM11/ RLA File :34/24/040/00235/AM10/ Lic.No/Date:3410026639 18.03.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/115/2010PI(Norms) dated 11.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export product Exp. Qty. Sl.No. Import items Qty. allowed Clarithromycin Coated Granules (28% to 44%, as per DML) 1 KG 1. Clarithromycin Net Content (as per DML) +1% WASTAGE OR Its raw material as per SION A2263 on prorata basis. 48
Case No.:22/14/82ALC4/2010
Party Name:DIVIS LABORATORIES LTD., 26.10.2010 Status:Case Approved HQ File :01/82/050/00384/AM11/ RLA File :09/24/040/00532/AM10/ Lic.No/Date:0910041417 24.03.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM. No.35011/90/2010PI(Norms) dated 1.10.2010 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 BIonylideneethyl Triphenyl Phosphonium Bromide 1 KG 1. Ethylene Dibromide 1.35 kg 2. Tetrahydrofuran 1.25 kg
Triphenylphosphine 0.69 kg 4. Methanol 2.32 kg 49
Case No.:9/1/82ALC4/2010
Party Name:HETERO LABS LIMITED 26.10.2010 Status:Case Approved HQ File :01/82/050/01240/AM10/ RLA File :09/24/040/00547/AM10/ Lic.No/Date:0910041459 25.03.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/68/2010PI(Norms) dated 5.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP Export product Exp. Qty. Sl.No. Import items Qty. allowed Didanosine 1 KG 1. 2,3Dideoxy Inosine 1.05 kg 2. Acetonitrile 2.50 kg 50
Case No.:13/1/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 26.10.2010 Status:Case Approved HQ File :01/82/050/01244/AM10/ RLA File :09/24/040/00546/AM10/ Lic.No/Date:0910041467 25.03.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/69/2010PI(Norms) dated 5.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP Export product Exp. Qty. Sl.No. Import items Qty. allowed Saquinavir Mesylate 1 KG 1. 1,3Dicyclohexyl Carbodiimide 1.10 kg 2. Activated Carbon 0.098 kg
Bromochloromethane 1.44 kg 4. Di Methyl formamide 1.40 kg 5. Iso Propyl Alcohol 1.81 kg 6. Lphenylalanine 1.151 kg 7. Asparagine Monohydrate 0.421 kg 8. Methane Sulphonic Acid 0.338 kg 9. Methanol 1.09 kg 10. Methylene Chloride 2.19 kg 11. NHydroxy Succinamide 0.344 kg 12. Tetrahydrofuran 4.05 kg 13. Tri Methyl Chlorosilane 0.778 kg 51
Case No.:15/2/82ALC4/2010
Party Name:COMBITIC GLOBAL CAPLET PVT. LTD. 26.10.2010 Status:Case Deferred HQ File :01/82/050/01249/AM10/ RLA File :33/24/040/00016/AM10/ Lic.No/Date:3310015180 Defer
26.03.2010 Date:21.12.2010 Decision : The Committee decided to call for a coy of DML from the firm and to defer the case for 21.12.10. 52
Case No.:4/2/82ALC4/2010
Party Name:HETERO LABS LIMITED 26.10.2010 Status:Case Deferred HQ File :01/82/050/00004/AM11/ RLA File :09/24/040/00568/AM10/ Lic.No/Date:0910041513 01.04.2010 Defer Date:23.11.2010 Decision :The case was deferred for comments of D/o Pharmaceuticals for 23.11.2010. 53
Case No.:29/18/82ALC4/2010
Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. 26.10.2010 Status:Case Deferred HQ File :01/82/050/00572/AM11/ RLA File :31/24/040/00001/AM11/ Lic.No/Date:3110042802 08.04.2010 Deferdate:23.11.2010 Decision :The Committee decided to defer the case for comments of D/o C&PC for 23.11.2010. 54
Case No.:48/22/82ALC4/2010
Party Name:AUCTUS PHARMA LIMITED 26.10.2010 Status:Case Deferred HQ File :01/82/050/00701/AM11/ RLA File :09/24/040/00535/AM10/ Lic.No/Date:0910041595 08.04.2010 Defer Date: 21.12.10 Decision :The Committee decided to defer the case for comments of D/o Pharmaceuticals for 21.12.2010. 55
Case No.:53/14/82ALC4/2010
Party Name:AUCTUS PHARMA LIMITED 26.10.2010 Status:Case Approved HQ File :01/82/050/00415/AM11/ RLA File :09/24/040/00557/AM10/ Lic.No/Date:0910041709 19.04.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM. No.35011/109/2010PI(Norms) dated 18.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export product Exp. Qty. Sl.No. Import items Qty. allowed (2S,5R)5Fluorocytosine1YL[1,3] Oxathiolane2 Carboxylic Acid Menthyl Ester (FCME) 1 kg 1. Glyoxalic Acid 0.34 kg 2. Cyclohexane 1.27 kg 3. 2,5Dihyroxy1,4 Diethane 0.28 kg
5Fluorocystone 0.531 kg 5. Methylene Chloride 8.54 kg RA may take action accordingly. 56
Case No.:48/14/82ALC4/2010
Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 26.10.2010 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 written comments forwarded by Department of Pharmaceuticals vide their OM. No.35011/120/2010PI(Norms) dated 18.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of 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 action accordingly. 57
Case No.:47/14/82ALC4/2010
Party Name:CHEMPRO EXPORTS (INDIA) 26.10.2010 Status:Case Rejected HQ File :01/82/050/00409/AM11/ RLA File :03/94/040/00028/AM11/ Lic.No/Date:0310570620 21.04.2010 Defer Date: Decision :The Committee noted that the firm has not submitted Central Excise Certified data ,as sought for vide DGFT’s letter dated 16.09.2010 and therefore decided to reject the case.
y y p 58
Case No.:20/14/82ALC4/2010
Party Name:AUCTUS PHARMA LIMITED 26.10.2010 Status:Case Approved HQ File :01/82/050/00382/AM11/ RLA File :09/24/040/00014/AM11/ Lic.No/Date:0910041796 23.04.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM. No.35011/109/2010PI(Norms) dated 18.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export product Exp. Qty. Sl.No. Import items Qty. allowed LMethyl Glyoxylate Hydrate (MGH) 1 kg 1. Glyoxalic Acid 0.39 kg 2. Cyclohexane 0.533 kg RA may take action accordingly. 59
Case No.:73/22/82ALC4/2010
Party Name:DIVIS LABORATORIES LTD., 26.10.2010 Status:Case Deferred HQ File :01/82/050/00726/AM11/ RLA File :09/24/040/00015/AM11/ Lic.No/Date:0910041826 27.04.2010 Defer Date:23.11.2010 60
Case No.:99/22/82ALC4/2010
Party Name:AUCTUS PHARMA LIMITED 26.10.2010 Status:Case Deferred HQ File :01/82/050/00752/AM11/ RLA File :09/24/040/00011/AM11/ Lic.No/Date:0910041827 27.04.2010 Defer Date:23.11.2010 61
Case No.:100/22/82ALC4/2010
Party Name:DIVIS LABORATORIES LTD., 26.10.2010 Status:Case Deferred HQ File :01/82/050/00753/AM11/ RLA File :09/24/040/00562/AM10/ Lic.No/Date:0910041845 28.04.2010 Defer Date:23.11.2010 62
Case No.:30/6/82ALC4/2010
Party Name:ALEMBIC LIMITED Status:Case
26.10.2010 Deferred HQ File :01/82/050/00177/AM11/ RLA File :34/24/040/00020/AM11/ Lic.No/Date:3410026932 29.04.2010 Defer Date:21.12.2010 Decision : : As per D/o Pharmaceuticals OM No. 35011/11/2010PI (Norms) dated 11.10.10 . the Committee decided to call for following information from the firm and decided to defer the case for 21.12.2010 : 1. Copy of Valid DML for each export product. 2. Copy of master batch formula for each export product duly certified by their Q.C. in charge showing net content and wastage claimed for each excipient. 63
Case No.:33/6/82ALC4/2010
Party Name:ARCH PHARMALABS LTD 26.10.2010 Status:Case Deferred HQ File :01/82/050/00180/AM11/ RLA File :03/94/040/00030/AM11/ Lic.No/Date:0310572376 30.04.2010 Defer Date:23.11.2010 64
Case No.:35/6/82ALC4/2010
Party Name:BALAJI AMINES LIMITED 26.10.2010 Status:Case Approved HQ File :01/82/050/00182/AM11/ RLA File :31/24/040/00011/AM11/ Lic.No/Date:3110043098 30.04.2010 Defer Date: Decision : : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/113/2008/Ch.II 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 NMethyl2Pyrrolidone 1 KG 1. Methanol 0.377 kg 2. Ammonia 0.164 kg 3. 1,4 Butanediol 1.01 kg 4. Methylamine Catalyst 0.00080 kg 5. GBL Catalyst 0.00075 kg
65
Case No.:4/7/82ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 26.10.2010 Status:Case Approved HQ File :01/82/050/00187/AM11/ RLA File :05/24/040/00001/AM11/ Lic.No/Date:0510263627 04.05.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/75/2010PI(Norms) dated 1.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP Export product Exp. Qty. Sl.No. Import items Qty. allowed Cilazapril 1 kg 1. () Rhydoxy4 phenylbutyric Acid Ethyl Este 1.20 kg 2. 1,2Dimethoxy Ethane (Monoglyme) 9.90 kg 3. 5 Bromo Valeric Acid 13.60 kg 4. Acetone 32.29 kg 5. Activated Carbon 0.100 kg 6. BF3 Etherate 7.51 kg 7. Dicyclohexyl Carbodimide (DCC) 15.49 kg 8. Diisopropyl Ether 6.77 kg 9. DMAP(4Dimtyyl Aminopyridine) 0.91 kg
Liquid Bromine 24.20 kg 11. Methanol 12.87 kg 12. Palladium 0.005 kg 13. P Nitrobenzene Sulfonyl Chloride 1.29 kg 14. Pyridine 6.54 kg 15. Tetrahydrofuran 13.94 kg 16. Triethylamine 5.22 kg 66
Case No.:61/14/82ALC4/2010
Party Name:JAYANT AGRO ORGANICS LTD., Meet No/Date:30/82ALC4/2010 26.10.2010 Status:Case Deferred HQ File :01/82/050/00423/AM11/ RLA File :03/94/040/00059/AM11/ Lic.No/Date:0310573847 12.05.2010 Defer Date:23.11.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/78/2010PI(Norms) dated 1.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP Export product Exp. Qty. Sl.No. Import items Qty. allowed 2(3(S)(3(2(7Chloro2Quinolinyl) Ethenyl)3Hydroxypropyl)Benzoic Acid Methylester Hydrate(MT7). 1 KG 1. 7Chloroquinaldine 1.22 kg 2. Isophthaladehyde 1.10 kg 3. Methyl2Iodobenzoate 1.074 kg
()Diisopinocampheyl Chloroborane in Heptane(6065% Solution)Active)UOM KGA) 1.427 kg 5. Toluene 2.668 kg 6. Tetrahydrofuran 4.84 kg 67
Case No.:17/8/82ALC4/2010
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 26.10.2010 Status:Case Approved HQ File :01/82/050/00206/AM11/ RLA File :05/24/040/00033/AM11/ Lic.No/Date:0510264144 12.05.2010 Defer Date: 23.11.2010 Decision : The Committee decided to defer the case for 23.11.10 for comments of D/o C&PC. 68
Case No.:55/14/82ALC4/2010
Party Name:LUPIN LIMITED 26.10.2010 Status:Case Approved HQ File :01/82/050/00417/AM11/ RLA File :03/95/040/00127/AM11/ Lic.No/Date:0310575276 20.05.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/78/2010PI(Norms) dated 1.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP Export product Exp. Qty. Sl.No. Import items Qty. allowed 7APCA 1 KG 1. GCLE(4 Methoxybenzyl 3Chloromethyl 7(2 Phenylacetamido)3 Cephem4 Carboxylate) 4.0323 kg 2. Dimthyl Formamide 0.50 kg 3. Triphenyl Phosphine 2.367 kg
Methylene Chloride 14.75 kg 5. Isopropyl Alcohol 10.90 kg 6. Tri Metyl Chloro Silane 0.221 kg 7. Acetone 1.51 kg 8. Tri Fluoro Acetic Acid 3.7102 kg 9. Activated Carbon 0.100 kg 69
Case No.:59/14/82ALC4/2010
Party Name:CIPLA LIMITED 26.10.2010 Status:Case Deferred HQ File :01/82/050/00421/AM11/ RLA File :03/94/040/00186/AM11/ Lic.No/Date:0310575233 20.05.2010 Defer Date:23.11.2010 Decision : The committee decided to remind M/o Environment & Forest for their comments and to defer the case for 23.11.2010 70
Case No.:6/22/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 26.10.2010 Status:Case Approved HQ File :01/82/050/00659/AM11/ RLA File :09/24/040/00070/AM11/ Lic.No/Date:0910042126 25.05.2010 Defer Date: Decision : : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/279/2010PI(Norms) dated 28.04.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export product Exp. Qty. Sl.No. Import items Qty. allowed Simvastatin 1 Kg. 1. Lovastatin 1.39 kg 2. Carbon DC Enoanticromos (Activated Carbon) 0.035 kg 3. Cyclohexane 6.66 kg
Methanol 16.01 kg 5. Iodine 0.5917 kg 6. Methane Sulfonic Acid 0.06 kg 7. Methylene Chloride 2.42 kg 8. N,NDimethyl formamide (DMF) 1.59 kg 9. Pyrrolidine 0.81 kg 10. TertButyldimethylsilyl Chloride 0.81 kg 11. Tetra Hydrofuran (THF) 6.58 kg 12. Imidazole 0.58 kg 13. nButyl Lithium (15% Solution in Hexane) As 100% 0.610 kg RA may take action accordingly. 71
Case No.:6/26/82ALC4/2010
Party Name:VIVIN LABORATORIES PRIVATE LIMITED 26.10.2010 Status:Case Approved HQ File :01/82/050/00824/AM11/ RLA File :09/24/040/00567/AM10/ Lic.No/Date:0910042108 25.05.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/78/2010PI(Norms) dated 1.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP Export product Exp. Qty. Sl.No. Import items Qty. allowed (2R,5R)5Hydroxy –(1,3) Oxathiolane2Carboxylic Acid,2S Isoppropyl5R Methyl1R Cyclohexylester. 1 kg 1. Glyoxalic Acid 50% 0.717 kg 2. 2,5 Di Hydroxy 1,4,Di Thiane 0.30 kg 3. NHexane 1.10 kg 4. Cyclohexane 1.48 kg 5. Toluene 0.67 kg 72
Case No.:9/22/82ALC4/2010
Party Name:K R R DRUGS & INTERMEDIATES PVT LTD 26.10.2010 Status:Case Deferred
HQ File :01/82/050/00662/AM11/ RLA File :09/24/040/00044/AM11/ Lic.No/Date:0910042151 26.05.2010 Defer Date:21.12.2010 Decision : The Committee decided to defer the case for 21.12.10 for comments of D/o Pharmaceuticals. 73
Case No.:10/22/82ALC4/2010
Party Name:FDC LTD 26.10.2010 Status:Case Deferred HQ File :01/82/050/00663/AM11/ RLA File :03/94/040/00954/AM10/ Lic.No/Date:0310576214 26.05.2010 Defer Date:21.12.10 Decision : The Committee decided to defer the case for 21.12.10 for comments of D/o Pharmaceuticals 74
Case No.:15/22/82ALC4/2010
Party Name:SUNWAYS LABORATORIES PVT. LTD. 26.10.2010 Status:Case Deferred HQ File :01/82/050/00668/AM11/ RLA File :03/95/040/00140/AM11/ Lic.No/Date:0310576643 31.05.2010 Defer Date:23.11.2010 75
Case No.:3/16/82ALC4/2010
Party Name:CADILA PHARMACEUTICALS LTD. 26.10.2010 Status:Case Approved HQ File :01/82/050/00519/AM11/ RLA File :08/24/040/00069/AM11/ Lic.No/Date:0810089371 02.06.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/279/2010PI(Norms) dated 28.04.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export product Exp. Qty. Sl.No. Import items Qty. allowed Nebivolol HCL 1 kg 1. 4Fluoro Anisole 10.15 kg 2. Ethylene Di Chloride 14.38 kg 3. Hexane 20.50 kg 4. Ethyl Acetate 18.58 kg 5. Acetic Acid 60.89 kg 6. Sodium Borohdride 1.678 kg 7. Tetra Hydrofuran 2.54 kg 8. Dichloro Methana 21.01 kg 9. Dimethyle Sulphoxide 5.81 kg 10. Methanol 21.57 kg 11. Isopropyl Alcohol 0.64 kg 12. Acetonitrile 0.34 kg RA may take action accordingly. 76
Case No.:20/22/82ALC4/2010
Party Name:ARCH PHARMALABS LTD 26.10.2010 Status:Case Deferred HQ File :01/82/050/00673/AM11/ RLA File :03/94/040/00211/AM11/ Lic.No/Date:0310577127 Defer
03.06.2010 Date:21.12.2010 Decision : The Committee decided to defer the case for 21.12.10 for comments of D/o Pharmaceuticals 77
Case No.:28/22/82ALC4/2010
Party Name:ARCH PHARMALABS LTD 26.10.2010 Status:Case Deferred HQ File :01/82/050/00681/AM11/ RLA File :03/94/040/00922/AM10/ Lic.No/Date:0310577746 07.06.2010 Defer Date:23.11.2010 78
Case No.:30/22/82ALC4/2010
Party Name:ADCOCK INGRAM LTD, 26.10.2010 Status:Case Approved HQ File :01/82/050/00683/AM11/ RLA File :07/24/040/00077/AM11/ Lic.No/Date:0710072219 14.06.2010 Defer Date: Decision :On the recommendations of TA from D/o Pharmaceuticals, the Committee 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 79
Case No.:32/22/82ALC4/2010
Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. 26.10.2010 Status:Case Deferred HQ File :01/82/050/00685/AM11/ RLA File :03/94/040/00230/AM11/ Lic.No/Date:0310579071 16.06.2010 Defer Date: 21.12.10 Decision : The Committee decided to defer the case for 21.12.10 for comments of D/o Pharmaceuticals 80
Case No.:34/22/82ALC4/2010
Party Name:WEXFORD LABORATORIES P LTD 26.10.2010 Status:Case Deferred HQ File :01/82/050/00687/AM11/ RLA File :07/24/040/00074/AM11/ Lic.No/Date:0710072310 17.06.2010 Defer Date:23.11.2010
Case No.:7/15/82ALC4/2010
Party Name:CADILA HEALTHCARE LTD.,
81 y , 26.10.2010 Status:Case Approved HQ File :01/82/050/00444/AM11/ RLA File :08/24/040/00096/AM11/ Lic.No/Date:0810090061 25.06.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/108/2010PI(Norms) dated 5.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP Export product Exp. Qty. Sl.No. Import items Qty. allowed Hydroxychloroquine Sulfate 200 mg tablet. 6958.00 kg 1 Tablet 1. Hydroxychloroquine Sulfate 204.00 mg 2. Dibasic Calcium Phosphate Dihydrate 106.00 mg 3. Other Items As per packing policy 82
Case No.:11/15/82ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 26.10.2010 Status:Case Approved HQ File :01/82/050/00448/AM11/ RLA File :08/24/040/00099/AM11/ Lic.No/Date:0810090128 29.06.2010 Defer Date: 23.11.10 Decision : : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/108/2010PI(Norms) dated 5.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP Export product Felodipine ER 5mg Tabket..86.25kgs &10 mg Tablet..172.50 kgs Exp. Qty. 1 Tablet Sl.No. Import items Qty. allowed 5.0 mg 10.0 mg Tablet tablet 1. Felodipine USP 5.1 10.0 2. Hydroxypropyl Cellulose NF (Klucel LF 23.0 23.0 3. Lactose Anhydrous NF (Pharmatose DCL21) 71.24 56.24 4. Hypromellose 50 CPS 157.50 157.50
Hypromellose 15 CPS 90.0 90.0 6. Bottles & Caps As per packing policy 83
Case No.:67/22/82ALC4/2010
Party Name: MADHUKAR HORMONES & STERODIS [P] LTD. 26.10.2010 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:23.11.2010 Decision : The Committee decided to defer the case for 23.11.10 for comments of D/o Pharmaceuticals. 84
Case No.:66/22/82ALC4/2010
Party Name:CIPLA LIMITED 26.10.2010 Status:Case Approved HQ File :01/82/050/00719/AM11/ RLA File :03/94/040/00296/AM11/ Lic.No/Date:0310581762 02.07.2010 Defer Date: Decision : : On the recommendations of TA from D/o Pharmaceuticals, the Committee decided to ratify adhoc norms under para 4.7 as under or as applied for whichever is lower: Export product Exp. Qty. Sl. No. Import items Qty. allowed Ivocip Drench 0.08%/ Ivermectin Drench 0.08% 1 litre pack 1. Ivermectin BP 0.808 gm 500 ml pack 1. Ivermectin BP 0.404 gm 85
Case No.:70/22/82ALC4/2010
Party Name:S.R.S.PHARMACEUTICALS PVT. LTD. 26.10.2010 Status:Case Approved HQ File :01/82/050/00723/AM11/ RLA File :03/95/040/00237/AM11/ Lic.No/Date:0310582031 06.07.2010 Defer Date: Decision : : On the recommendations of TA from D/o Pharmaceuticals, the Committee decided to ratify adhoc norms under para 4.7 as under or as applied for whichever is lower: Export product Exp. Qty. Sl. No. Import items Qty. allowed Capsule(Silymarine 140 mg, Thiamine NItrate 4mg, Riboflavan 4 mg, Pyridoxin HCL4 mg,Nicotinamide 12 mg,Paantothenate 8mg) 1 Capsule 1. Silymarine 80% Silybum Marianmum Extract 178.5 mg
86
Case No.:98/22/82ALC4/2010
Party Name:SYMBIOTEC PHARMALAB LTD., Meet No/Date:30/82ALC4/2010 26.10.2010 Status:Case Approved HQ File :01/82/050/00751/AM11/ RLA File :11/24/040/00042/AM09/ Lic.No/Date:1110022752 07.07.2010 Defer Date: Decision : : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM. No.35011/117/2010PI(Norms) dated 18.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export product Exp. Qty. Sl.No. Import items Qty. allowed Tiramcinoline Acetonide 1 kg 1. Prednisolone 1.334 kg RA may take action accordingly. 87
Case No.:87/22/82ALC4/2010
Party Name:CIPLA LIMITED 26.10.2010 Status:Case Approved HQ File :01/82/050/00740/AM11/ RLA File :03/94/040/00319/AM11/ Lic.No/Date:0310582931 12.07.2010 Defer Date: Decision : On the recommendations of TA from D/o Pharmaceuticals, the Committee decided to ratify adhoc norms under para 4.7 as under or as applied for whichever is lower: Export product Exp. Qty. Sl. No. Import items Qty. allowed Mycomulin 45%/Mycomulin 45% feed Premix /(Per Pack 100 gm) 1 Pack 1. Tiamulin Hydrogen Fumarate 45.45 gm 88
Case No.:108/22/82ALC4/2010
Party Name:MEDCHL CHEMICALS AND PHARMACEUTICALS PVT LTD 26.10.2010 Status:Case Deferred HQ File :01/82/050/00761/AM11/ RLA File :09/24/040/00028/AM11/ Lic.No/Date:0910042684 14.07.2010 Defer Date:21.12.2010 Decision : The Committee decided to defer the case for 21.12.10 for comments of D/ 0 C&PC. 89
Case No.:97/22/82ALC4/2010
Party Name:TONIRA PHARMA LTD, 26.10.2010 Status:Case Deferred HQ File :01/82/050/00750/AM11/ RLA File :34/24/040/00073/AM11/ Lic.No/Date:3410027520 16.07.2010 Defer Date:21.12.2010 Decision : The Committee decided to defer the case for 21.12.10 for comments of D/o Pharmaceuticals. 90
Case No.:101/22/82ALC4/2010
Party Name:TONIRA PHARMA LTD, 26.10.2010 Status:Case Deferred
HQ File :01/82/050/00754/AM11/ RLA File :34/24/040/00072/AM11/ Lic.No/Date:3410027519 16.07.2010 Defer Date:21.12.2010 Decision : The Committee decided to send a copy of application to D/o Pharmaceuticals and to defer the case for 21.12.10. 91
Case No.:85/22/82ALC4/2010
Party Name:CIPLA LIMITED 26.10.2010 Status:Case Deferred HQ File :01/82/050/00738/AM11/ RLA File :03/94/040/00350/AM11/ Lic.No/Date:0310584093 19.07.2010 Defer Date:23.11.2010 92
Case No.:4/22/82ALC4/2010
Party Name:MEHTA (API) PVT.LTD 26.10.2010 Status:Case Deferred HQ File :01/82/050/00657/AM11/ RLA File :03/95/040/00358/AM11/ Lic.No/Date:0310587875 16.08.2010 Defer Date:21.12.2010 Decision : The Committee decided to defer the case for 21.12.10 for comments of D/o Pharmaceuticals. 93
Case No.:46/22/82ALC4/2010
Party Name:MAHAVIR INTERMEDIATES 26.10.2010 Status:Case Deferred HQ File :01/82/050/00699/AM11/ RLA File :52/24/040/00005/AM11/ Lic.No/Date:5210031651 18.08.2010 Defer Date:23.11.2010 Decision : The Committee noted that the firm has sent its reply and decided to defer the case for 23.11.10 for comments of D/o C&PC. 94
Case No.:1/30/82ALC4/2010
Party Name:N S CHEMICALS 26.10.2010 Status:Case Approved HQ File :01/82/050/00920/AM11/ RLA File :03/95/040/00306/AM11/ Lic.No/Date:0310595343 06.10.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14110/2010Ch.) dated 29.3..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 Sodium Saccharin USP 1 KG 1. Sodium Saccharin Technical Grade 1.02 kg RA may take action accordingly. 95
Case No.:4/30/82ALC4/2010
Party Name:PRACHI PHARMACEUTICALS PVT LTD 26.10.2010 Status:Case Deferred HQ File :01/82/050/00923/AM11/ RLA File :03/95/040/00095/AM11/ Lic.No/Date:0310595471 Defer
06.10.2010 Date:21.12.2010 Decision : The Committee decided to defer the case for 21.12.10 for comments of D/o Pharmaceuticals. 96
Case No.:6/30/82ALC4/2010
Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 26.10.2010 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:21.12.2010 Decision : The Committee decided to defer the case for 21.12.10 for comments of D/o C&PC. 97
Case No.:5/30/82ALC4/2010
Party Name:VIC INDUSTRIES, 26.10.2010 Status:Case Deferred HQ File :01/82/050/00924/AM11/ RLA File :17/24/040/00064/AM09/ Lic.No/Date:1710003530 07.10.2010 Defer Date:21.12.2010 Decision : The Committee decided to defer the case for 21.12.10 for comments of D/o C&PC. 98
Case No.:2/30/82ALC4/2010
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 26.10.2010 Status:Case Deferred HQ File :01/82/050/00921/AM11/ RLA File :05/23/040/00168/AM11/ Lic.No/Date:0510274506 08.10.2010 Defer Date:21.12.2010 Decision : The Committee decided to defer the case for 21.12.10 for comments of D/o Pharmaceuticals. 99
Case No.:3/30/82ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 26.10.2010 Status:Case Deferred HQ File :01/82/050/00922/AM11/ RLA File :05/24/040/00233/AM11/ Lic.No/Date:0510274511 08.10.2010 Defer Date:23.11.2010 Decision : The Committee decided to defer the case for 23.11.10 for comments of D/o Pharmaceuticals. OutsideAgenda The Committee considered M/s Cipla Ltd.’s request for correction in description of import item as ‘2Amino1,9dihydro9(IS,3R,4S)4(benzyloxy)3( Benzyloxymethyl).2 Methylenecyclopentyl]6Hpurin6one[ECR4]’ in place of ‘ 2Amino1,9(IS,3R,4S)4(benzyloxy)3(Benzyloxymethyl).2 Methylenecyclopentyl]6Hpurin6one[ECR4]’ in Advance Licenses No.03105352511 dated 26.08.09; 0310552339 dated 23.12.09 and 0310554460 dated 08.10.10 and decided to change it as ‘2Amino1,9dihydro9(IS,3R,4S)4(benzyloxy)3(benzyloxy)3( Benzyloxymethyl).2 Methylenecyclopentyl]6Hpurin6one[ECR4]‘ There will be no other change in earlier relevant NCs’ decisions . RA may take action accordingly.
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