DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi 0
Para 4.7 Decision
MEETING NUMBER : 27/82ALC4/2010 MEETING DATE : 05.10.2010 The Meeĕng No.27/82 in the year 2010‐11 to consider the cases under Duty Exempĕon Scheme (Chapter‐4) of Foreign Trade Policy, 2009‐14 pertaining to products falling in Chapter 29 and 30 was held on 05.10.2010 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 D.N. Mathur, Dy. IA, Department of Pharmaceuĕcals 4. Shri Krishan Kumar, Dy. DGFT 5. Shri Shyam Lal, FTDO At the outset, minutes of Norms Commiĥee Meeĕng No. 25/82 dated 21.09.2010 were raĕfied by the Commiĥee. Commiĥee requested the members from technical authoriĕes viz.Shri Jasbir Singh, IA, Department of C&PC, Shri Shaish Kumar, IA, DIPP and Shri D.N. Mathur, Dy. IA, Department of Pharmaceuĕcals to idenĕfy the Scomet and ODS items and to submit a report in the maĥer to the Commiĥee.
Case No. B229
M/s Alembic Ltd. Norms Committee Meeting No. 27/11 F.No.01/82/162/00064/AM08/DESIII Meeting Date 05.10.2010 RLA F. No. 34/24/040/00045/AM08 Adv. Lic. No.3410018932 dated 07.06.2007 Committee considered case as per agenda and in light of its earlier decision taken in its 28/82 meeting held on 13.11.2007 and in consultation with technical authority present in meeting, decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower on repeat basis: Export product Export Qty. Sl.No. Import item Qty. allowed Azithromycin Step IV (Azithromycin Crude Purity not less than 94.5%) 1 Kg. 1. Erythromycin Base 1.75 kg 2. Acetone 6.45 kg 3. Ethyl Alcohol 2.81 kg 4. Hydroxylamine Hcl 0.91 kg 5. Methane Sulfonyl Chloride 0.72 kg 6. Methanol 2.72 kg 7. Platinum Catalyst with base of activated carbon (5% platinum on carbon 1.00 Gram RA concerned may take further necessary action as per above decision of NC.
Case No. B230
M/s India Glycol Ltd. F.No.01/82/050/00232/AM06/DESIII RLA F. No. 05/24/40/156/AM06 Adv. Lic. No.0510159282 dt. 07.06.05 Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their O.M. No.46011/89/2007PC.II dated 31.08.2010 and in consultation with technical authority present in meeting, decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower on repeat basis: Export product Export Qty. Sl.No. Import item Qty. allowed Diethylene Glycol (DEG) 1 MT. 1. Denatured Ethyl Alcohol 1.441 MT
Case No. B231
M/s Reliance Industries Ltd. F.No.01/82/162/00765/AM10/DESIII Committee considered case as per agenda for fixation of value addition for DEPB for the export product Benzene and observed that as per the import and export data furnished by DGCIS, the value addition works out 47.33%. However, the Committee decided to recommend 50% value addition for fixation of DEPB rate.
Case No. B232
M/s Ratnagiri Chemicals Pvt. Ltd, F.No.01/82/050/00077/AM11/DESIII RLA F. No. 03/95/040/00745/AM10 Adv. Lic. No.0310560168 dated 15.02.2010 Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/97/2006‐Ch.II dated 05.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Hydroquinone Monomethyl Ether (Purity Min.99.5%) 1 kg 1. Hydroquinone 1.11 kg 2. Para Benzoquinone 0.15 kg RA concerned may take further necessary action as per above decision of NC. The earlier decision takne in 5/82 meeting held on 04.05.2010 stands withdrawn.
Case No. B233
M/s Punjab Chemicals & Crop Protection Ltd. F.No.01/82/050/00106/AM10/DESIII RLA F. No. 03/95/040/01022/AM09
Adv. Lic. No.0310513269 dated 25.03.2010 Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to maintain earlier decision taken in 17/82 meeting held on 27.07.2010 as there is no justification for enhancement in the quantity of inputs. However, on the recommendation of T.A. from Department of C&PC, Committee decided to change description of import items as under, as per request of the firm: (1) 3,4,5‐Tri Methoxy Benzaldehyde. (2) Hydrazine Hydrate 100%: and (3) Polyethylene Glycol (PEG‐600) Further the Committee noted that quantity of import item of Sl.No.(2) above was not shown correctly and accordingly decided to change quantity of this item as 0.420 kg/kg of export product instead of 4.20 kg/kg of export product. RA may take action accordingly.
Case No. A32
M/s Intas Pharma Ltd. F.No.01/82/162/00205/AM10/DESIII RLA F. No. 08/24/040/00007/AM10 Adv. Lic. No.0810079232 dated 09.04.2009 Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/98/2010‐PI (Norms) dated 01.10.2010 and in consultaĕon with representaĕve of Department of Pharmaceuĕcals present in meeĕng, decided to raĕfy 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 Tarazosin Hydrochloride Tabs 1.0 mg 1 No. 1. Tarazosin Hcl (As Dihydrate) USP 1.2129 mg 2. EHG cap White Opaque (0999) white opaque3 As per packing policy 3. 33 MM PP CTC with T. Seal HS130 PTD WADDMF 4. 1 G Silica Gel Canister (Sorbcap) DMF 5. 53 MM PPCTC with T. Seal HS130 PTD WADDMF Tarazosin Hydrochloride Tabs 2.0 mg 1 No. 1. Tarazosin Hcl (As Dihydrate) USP 2.4217 mg 2. EHG cap White Opaque (0999) white opaque3 3. 33 MM PP CTC with T. Seal HS130 PTD WADDMF 4. 1 G Silica Gel Canister (Sorbcap) DMF
53 MM PPCTC with T. Seal HS130 PTD WADDMF Tarazosin Hydrochloride Tabs 5.0 mg 1 No. 1. Tarazosin Hcl (As Dihydrate) USP 6.0544 mg 2. EHG cap White Opaque (0999) white opaque3 3. 33 MM PP CTC with T. Seal HS130 PTD WADDMF 4. 1 G Silica Gel Canister (Sorbcap) DMF 5. 53 MM PPCTC with T. Seal HS130 PTD WADDMF Tarazosin Hydrochloride Tabs 10.0 mg 1 No. 1. Tarazosin Hcl (As Dihydrate) USP 12.1087 mg 2. EHG cap White Opaque (0999) white opaque3 3. 33 MM PP CTC with T. Seal HS130 PTD WADDMF 4. 1 G Silica Gel Canister (Sorbcap) DMF 5. 53 MM PPCTC with T. Seal HS130 PTD WADDMF Commiĥee has not allowed import of items at sl. No. 2 to 7 and the same are not required for manufacturing tablets as per details furnished by the firm.
Case No. A33
M/s Oleofine Organics (India) Ltd, Mumbai F.No.01/82/162/00550/AM11/DESIII RLA F. No. 03/95/040/00361/AM11 Adv. Lic. No.Case under para 4.4.2 of HBP Committee considered case as per agenda and observed that there is no condition for import item items falling under Chapter 15 for Advance Authorisation to be issued under para 4.4.2 of HBP, but the Directorate of Vanaspati, Vegetable Oils and Fats in the case of M/S Medreich Ltd has advised to obtain NOC from their Department on case to case basis. Committee also observed that the written technical comments have been received from Department of C&PC. After detailed deliberations and in consultation with technical authorities present in meeting, Committee decided to seek comments/NOC from Directorate of Vanaspati, Vegatable Oils and Fats. Accordingly, the case was deferred for 30.11.2010.
Case No. A34
M/s Oleofine Organics (India) Ltd, Mumbai F.No.01/82/162/00551/AM11/DESIII
RLA F. No. 03/95/040/00257/AM11 Adv. Lic. No.Case under para 4.4.2 of HBP Committee considered case as per agenda and observed that there is no condition for import item items falling under Chapter 15 for Advance Authorisation to be issued under para 4.4.2 of HBP, but the Directorate of Vanaspati, Vegetable Oils and Fats in the case of M/S Medreich Ltd has advised to obtain NOC from their Department on case to case basis. Committee also observed that the written technical comments have been received from Department of C&PC. After detailed deliberations and in consultation with technical authorities present in meeting, Committee decided to seek comments/NOC from Directorate of Vanaspati, Vegatable Oils and Fats. Accordingly, the case was deferred for 30.11.2010. 1
Case No.:29/41/82ALC4/2008
Party Name:ARCH PHARMALABS LTD Meet No/Date:27/82ALC4/2010 05.10.2010 Status:Case Deferred HQ File :01/82/050/01469/AM09/ RLA File :03/94/040/00752/AM09/ Lic.No/Date:0310493255 06.11.2008 Defer Date:30.11.2010 Decision :Committee decided to defer case for 30.11.2010 for comments of Department of Pharmaceuticals. 2
Case No.:19/35/82ALC4/2008
Party Name:VIJAYASRI ORGANICS LTD 05.10.2010 Status:Case Deferred HQ File :01/82/050/01275/AM09/ RLA File :09/24/040/00287/AM09/ Lic.No/Date:0910035950 17.11.2008 Defer Date:30.11.2010 Decision : Committee noted that reply is not forthcoming from office of DC(MSME). T.A. from Department of Pharmaceuticals mentioned that the export product is also used in Pharma industry and they he would pay special attention to see that comments of Department of Pharma are received by the defer date of 30.11.2010. 3
Case No.:1/40/82ALC4/2008
Party Name:INTAS PHARMACEUTICALS LTD., 05.10.2010 Status:Case Approved HQ File :01/82/050/01420/AM09/ RLA File :08/24/040/00187/AM09/ Lic.No/Date:0810076754 16.12.2008 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments of Department of Pharmaceuĕcals and in consultaĕon with representaĕve of Department of Pharmaceuĕcals present in meeĕng, decided to raĕfy 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 Labetalol Hydrochloride Tabs 50 mg 600000 Nos 1. Hypromellose E15[E] Not shown in Master Batch Formula. Hence not allowed. 2. Lactose Mono (Pharma 200M) DMVP EUR and USNF 44.966 kg 3. Sodium Starch Glycoate Type A(E) 10.20 kg Labetalol Hydrochloride 600000 Nos.
Tabs 100 mg 4. Maize Starch BP 45.52 kg 5. Labetalol Hydrochloride EP/BP/USP 260.10 kg Labetalol Hydrochloride Tabs 200 mg 825000 Nos. 6. 33 MM PP CRC with Selig Seal WadDMF 4
Case No.:27/42/82ALC4/2008
05.10.2010 Status:Case Deferred HQ File :01/82/050/01505/AM09/ RLA File :03/94/040/00904/AM09/ Lic.No/Date:0310501134 05.01.2009 Defer Date:30.11.2010 Decision : The Committee noted that reply from office of DC(MSME) was not coming and decided to defer case for 30.11.2010 with a request to Department of Pharmaceuticals to expedite their comments. 5
Case No.:28/42/82ALC4/2008
05.10.2010 Status:Case Deferred HQ File :01/82/050/01506/AM09/ RLA File :03/94/040/00920/AM09/ Lic.No/Date:0310501141 05.01.2009 Defer Date:30.11.2010 Decision :Committee decided to forward a copy of application to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 30.11.2010. 6
Case No.:55/18/82ALC4/2009
05.10.2010 Status:Case Deferred HQ File :01/82/050/00329/AM10/ RLA File :03/94/040/00949/AM09/ Lic.No/Date:0310503316 21.01.2009 Defer Date:30.11.2010 Decision :Committee decided to forward a copy of application alongwith a copy of reply received from the firm to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 30.11.2010. 7
Case No.:4/54/82ALC4/2008
Party Name:PADMINI AROMATICS PVT. LTD 05.10.2010 Status:Case Approved HQ File :01/82/050/01706/AM09/ RLA File :07/24/040/00660/AM09/ Lic.No/Date:0710063727 19.03.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/113/2007‐Ch.II dated 04.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Sabanol SA (2Methyl4(2,2,3trimethyl3 1 kg. 1. Alpha Pinene 1.600 kg
Cyclopentenyl)2buten1ol) 2. Sodium Borohydride 0.076 kg Woodamber SA (1,(2,2,6Trimethyl Cyclohexyl)Hexan3ol) 1 kg. 1. Citral 1.25 jg 2. Methyl Propyl Ketone 1.50 kg 3. Nickel Catalysts 0.06 kg Alpha Damascone 1 kg 1. Citral 1.583 kg 8
Case No.:54/1/82ALC4/2009
Party Name:RA CHEM PHARMA LIMITED 05.10.2010 Status:Case Approved HQ File :01/82/050/01774/AM09/ RLA File :09/24/040/00460/AM09/ Lic.No/Date:0910037582 31.03.2009 Decision :Withdrawn as the case has already been approved by NC in its 24/82 meeting held on 14.09.2010. 9
Case No.:9/2/82ALC4/2009
05.10.2010 Status:Case Deferred HQ File :01/82/050/00009/AM10/ RLA File :03/94/040/01131/AM09/ Lic.No/Date:0310514341 02.04.2009 Defer Date:30.11.2010 Decision : Committee decided to defer case for 30.11.2010 for comments of Department of Pharmaceuticals. 10
Case No.:66/18/82ALC4/2009
Party Name:CORVINE CHEMICALS & PHARMACEUTICALS LIMITED, 05.10.2010 Status:Case Deferred HQ File :01/82/050/00340/AM10/ RLA File :07/24/040/00009/AM10/ Lic.No/Date:0710064113 13.04.2009 Defer Date:30.11.2010 Decision :Committee decided to defer case for 30.11.2010 for comments of Department of C&PC. 11
Case No.:21/18/82ALC4/2009
Party Name:ELPPE CHEMICALS PRIVATE LIMITED 05.10.2010 Status:Case Deferred HQ File :01/82/050/00295/AM10/ RLA File :03/94/040/01082/AM09/ Lic.No/Date:0310515875 16.04.2009 Defer Date:30.11.2010 Decision : Committee decided to defer case for 30.11.2010 for comments of Department of C&PC. 12
Case No.:7/9/82ALC4/2009
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 05.10.2010 Status:Case Deferred HQ File :01/82/050/00120/AM10/ RLA File :04/24/040/00040/AM10/ Lic.No/Date:0410104760 21.05.2009 Defer Date:30.11.2010 Decision :Committee considered case as per agenda and observed that the required information has been received from the firm and a copy of reply alongwith a
copy of application has been sent to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 30.11.2010. 13
Case No.:36/18/82ALC4/2009
Party Name:CHEMILL NUTRACEUTICALS PVT.LTD. 05.10.2010 Status:Case Rejected HQ File :01/82/050/00310/AM10/ RLA File :03/94/040/00148/AM10/ Lic.No/Date:0310521537 27.05.2009 Decision :Withdrawn as the case has already been rejected by NC in its 22/82 meeting held on 31.08.2010. 14
Case No.:13/10/82ALC4/2009
Party Name:VASUDHA PHARMA CHEM LTD Meet No/Date:27/82ALC4/2010 05.10.2010 Status:Case Deferred HQ File :01/82/050/00137/AM10/ RLA File :09/24/040/00055/AM10/ Lic.No/Date:0910038020 28.05.2009 Defer Date:30.11.2010 15
Case No.:9/13/82ALC4/2009
Party Name:ENCUBE ETHICALS PVT LTD 05.10.2010 Status:Case Deferred HQ File :01/82/050/00149/AM10/ RLA File :03/94/040/00063/AM10/ Lic.No/Date:0310522513 03.06.2009 Defer Date:30.11.2010 Decision : Committee decided to defer case for 30.11.2010 for reply from the firm. 16
Case No.:30/13/82ALC4/2009
Party Name:SHILPA MEDICARE LTD., 05.10.2010 Status:Case Approved HQ File :01/82/050/00170/AM10/ RLA File :07/24/040/00103/AM10/ Lic.No/Date:0710065349 11.06.2009 Decision :Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/76/2010PI (Norms) dated 05.10.2010, decided to call for the following information from the firm: 1. % yield on molar basis for each step of manufacturing process. 2. Molar requirement of input in the process. 3. Requirement & recovery of solvent of each step. 4. Producĕon and actual past consumpĕon data duly cerĕfied by Central Excise Authority for the last 3 years. Accordingly, case was deferred for 30.11.2010. 17
Case No.:20/18/82ALC4/2009
05.10.2010 Status:Case Deferred HQ File :01/82/050/00294/AM10/ RLA File :03/94/040/00087/AM10/ Lic.No/Date:0310524765 18.06.2009 Defer Date:30.11.2010
18
Case No.:13/21/82ALC4/2009
Party Name:SURYA PHARMACEUTICAL LTD 05.10.2010 Status:Case Deferred HQ File :01/82/050/00440/AM10/ RLA File :22/24/040/00014/AM10/ Lic.No/Date:2210009017 22.06.2009 Defer Date:30.11.2010 Decision : Committee considered case as per agenda and observed that the required information has been received from the firm and a copy of reply alongwith a copy of application has been sent to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 30.11.2010. 19
Case No.:23/15/82ALC4/2009
Party Name:VIVIMED LABS LIMITED 05.10.2010 Status:Case Deferred HQ File :01/82/050/00252/AM10/ RLA File :09/24/040/00109/AM10/ Lic.No/Date:0910038369 29.06.2009 Defer Date:30.11.2010 Decision :Committee decided to defer case for 30.11.2010 for comments of Department of C&PC. 20
Case No.:4/17/82ALC4/2009
Party Name:SARAF CHEMICALS LTD. 05.10.2010 Status:Case Approved HQ File :01/82/050/00267/AM10/ RLA File :03/95/040/00207/AM10/ Lic.No/Date:0310527468 06.07.2009 Decision : Commiĥee considered case as per agenda and taking 80% yield and in consultaĕon with technical authoriĕes present in meeĕng, decided to raĕfy 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 5Ethyl Pyridine2Ethanol 1 Kg. 1. 5Ethyl2Methyl Pyridine 1.00 kg 21
Case No.:7/17/82ALC4/2009
Party Name:LAKE CHEMICALS PRIVATE LIMITED 05.10.2010 Status:Case Approved HQ File :01/82/050/00270/AM10/ RLA File :07/24/040/00051/AM10/ Lic.No/Date:0710065810 07.07.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/64/2010‐PI (Norms) dated 01.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 8Chloro3A, 4Dihydro6(2 Fluorophenyl)1Methyl3H Imidazo(1,5A)(1,4) Benzodiazepine 1 Kg. 1. 2Amino Methyl7Chloro23Dihydro 5(2Flurophenyl) 1H1,4 Benzodiazepine Dimaleate 2.52 kg 2. Triethyl Ortho Acetate 0.90 kg
22
Case No.:10/17/82ALC4/2009
Party Name:PARABOLIC DRUGS LTD., 05.10.2010 Status:Case Deferred HQ File :01/82/050/00273/AM10/ RLA File :05/24/040/00203/AM10/ Lic.No/Date:0510245516 10.07.2009 Defer Date:30.11.2010 Decision : Committee considered case as per agenda and observed that the required information has been received from the firm and a copy of reply alongwith a copy of application has been sent to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 30.11.2010. 23
Case No.:15/29/82ALC4/2009
Party Name:AUROBINDO PHARMA LIMITED 05.10.2010 Status:Case Approved HQ File :01/82/050/00585/AM10/ RLA File :09/24/040/00006/AM10/ Lic.No/Date:0910038659 23.07.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/88/2010‐PI (Norms) dated 05.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Valsartan 1 Kg. 1. LValine 0.935 kg 2. 2Cyano 4Methyl Bi Phenyl/Ortho Toluyl Benzonitrile 2.33 kg 3. Triethylamine (TEA) 4.417 kg 4. Carbon Eoanticromos (Activated Carbon) 0.100 kg 5. Acetone 0.90 kg 6. Dimethyl Formamide (DMF) 0.855 kg 7. Methanol 6.46 kg 8. Isopropyl Alcohol 0.20 kg 9. Steam/Thermal Coal RA concerned may take further necessary acĕon as per above decision of NC. 24
Case No.:5/19/82ALC4/2010
Party Name:ASTRIX LABORATORIES LTD., 05.10.2010 Status:Case Deferred HQ File :01/82/050/00590/AM11/ RLA File :09/24/040/00119/AM10/ Lic.No/Date:0910038697 24.07.2009 Defer Date:30.11.2010 Decision :Committee decided to call for a copy of application, copy of Advance Authorisation, copy of DML and technical details from RA/firm. Accordingly, case was deferred for 30.11.2010. 25
Case No.:26/21/82ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD Status:Case
05.10.2010 Deferred HQ File :01/82/050/00453/AM10/ RLA File :09/24/040/00112/AM10/ Lic.No/Date:0910038897 12.08.2009 Defer Date:30.11.2010 Decision : Committee considered case as per agenda and observed that the required information has been received from the firm and a copy of reply alongwith a copy of application has been sent to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 30.11.2010. 26
Case No.:60/5/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 05.10.2010 Status:Case Approved HQ File :01/82/050/00094/AM11/ RLA File :09/24/040/00198/AM10/ Lic.No/Date:0910039255 08.09.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/58/2010‐PI (Norms) dated 01.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Tenofovir Disoproxil Fumarate 1 Kg. 1. Adenine (6 Amino Purine) 0.914 kg 2. (R) Propylene Carbonate 0.7938 kg 3. Diethyl PToluene Sulphonyloxy Methyl Phosphonate 2.025 kg 4. Chloromethyl Iso Propyl Carbonate 2.0867 kg 5. Magnesium Tert Butoxide 0.536 kg 6. Hydrobromic Acid (48% w/w Aq. Solution) 6.54 kg 7. Triethylamine 1.028 kg 8. Dimethyl Formamide 2.04 kg 9. NMethyl Pyrrolidinone 3.92 kg 10. Methylene Chloride 8.82 kg 11. Acetone 0.71 kg 12. Iso Propyl Alcohol 4.65 kg 13. Cyclohexane 1.79 kg 27
Case No.:46/46/82ALC4/2009
Party Name:TADIMETY AROMATICS PVT. LTD 05.10.2010 Status:Case Approved HQ File :01/82/050/00962/AM10/ RLA File :07/24/040/00221/AM10/ Lic.No/Date:0710067059 17.09.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/57/2010‐Ch.II dated 21.06.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by
Export product Exp. Qty. Sl.No. Import items Qty. allowed Isononyl Acetate 1 Kg. 1. Nonanol (Isononyl Alcohol) 0.862 kg 28
Case No.:6/28/82ALC4/2009
Party Name:PARABOLIC DRUGS LTD., 05.10.2010 Status:Case Deferred HQ File :01/82/050/00566/AM10/ RLA File :05/24/040/00275/AM10/ Lic.No/Date:0510249610 18.09.2009 Defer Date:30.11.2010 29
Case No.:3/29/87ALC1/2009
Party Name:PARABOLIC DRUGS LTD., 05.10.2010 Status:Case Deferred HQ File :01/87/050/00216/AM10/ RLA File :05/24/040/00302/AM10/ Lic.No/Date:0510250358 06.10.2009 Defer Date:30.11.2010 Decision : Committee considered case as per agenda and observed that the required information has been received from the firm and a copy of reply alongwith a copy of application has been sent to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 30.11.2010. 30
Case No.:22/34/82ALC4/2009
Party Name:SCITECH SPECIALITIES PVT. LTD. 05.10.2010 Status:Case Approved HQ File :01/82/050/00667/AM10/ RLA File :03/95/040/00470/AM10/ Lic.No/Date:0310543476 30.10.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments of Department of C&PC and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Cevamune Tablets Chlorine Nutrilizer 1 No. 1. Stablizer/AntiOxidant Blend 0.0041 kg Thio Tracer (Chlorine Nutrilizer) Tablets 1 No. 1. Stablizer/AntiOxidant Blend 0.0041 kg 31
Case No.:70/48/82ALC4/2009
Party Name:CHEMPRO EXPORTS (INDIA) 05.10.2010 Status:Case Approved HQ File :01/82/050/01133/AM10/ RLA File :03/94/040/00613/AM10/ Lic.No/Date:0310544665 09.11.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/15/2007‐Ch.II dated 22.09.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by
Export product Exp. Qty. Sl.No. Import items Qty. allowed Dehydro ThioPara Toluidine Sulfonic Acid 1 Kg. 1. Para Toluidine 1.852 kg 32
Case No.:96/46/82ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 05.10.2010 Status:Case Deferred HQ File :01/82/050/01012/AM10/ RLA File :09/24/040/00268/AM10/ Lic.No/Date:0910039892 12.11.2009 Defer Date:30.11.2010 Decision : Committee considered case as per agenda and observed that the required information has been received from the firm and a copy of reply alongwith a copy of application has been sent to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 30.11.2010. 33
Case No.:13/36/82ALC4/2009
Party Name:CIPLA LIMITED 05.10.2010 Status:Case Approved HQ File :01/82/050/00738/AM10/ RLA File :03/94/040/00684/AM10/ Lic.No/Date:0310545824 16.11.2009 Decision : Commiĥee considered case as per agenda and in consultaĕon with representaĕve of Department of Pharmaceuĕcals present in meeĕng, decided to raĕfy 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 TyloDox Plus Powder/Tylosin and Doxycycline Powder (Pack size 1 kg) 1 No. 1. Tylosin Tartrate BP (Vet) 0.101 kg/pack 2. Doxycycline Hydrochloride 0.202 kg/pack 34
Case No.:29/5/82ALC4/2010
Party Name:AVA CHEMICALS PVT.LTD., 05.10.2010 Status:Case Approved HQ File :01/82/050/00063/AM11/ RLA File :03/94/040/00657/AM10/ Lic.No/Date:0310547230 24.11.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/110/2007‐Ch.II dated 17.05.2010 and U.O. No.14010/110/2007/Ch.II dated 14.06.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Disodium Zinc EDTA (Zinc content 1415%) 1 Kg. 1. Ethylene Diamine Tetra Acetic Acid (EDTA) 0.690 kg
Zinc Diammonium EDTA Liquid Zinc content 9% (+1) 1 Kg. 1. Ethylene Diamine Tetra Acetic Acid (EDTA) 0.422 kg Copper Diammonium EDTA – Liquid Copper content 9% (+1) 1 kg. 1. Ethylene Diamine Tetra Acetic Acid (EDTA) 0.436 kg 35
Case No.:15/38/82ALC4/2009
Party Name:VIVIMED LABS LIMITED 05.10.2010 Status:Case Deferred HQ File :01/82/050/00788/AM10/ RLA File :09/24/040/00362/AM10/ Lic.No/Date:0910040144 03.12.2009 Defer Date:30.11.2010 36
Case No.:16/38/82ALC4/2009
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 05.10.2010 Status:Case Rejected HQ File :01/82/050/00789/AM10/ RLA File :09/24/040/00352/AM10/ Lic.No/Date:0910040145 03.12.2009 Decision :Committee considered case as per agenda and observed that the firm was requested to furnish technical information vide letter dated 21.06.2010, but the same have not been received and norms can not be fixed in absence of the required information. It was, accordingly, decided to reject the case. 37
Case No.:20/38/82ALC4/2009
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 05.10.2010 Status:Case Rejected HQ File :01/82/050/00793/AM10/ RLA File :09/24/040/00355/AM10/ Lic.No/Date:0910040146 03.12.2009 Decision : Committee considered case as per agenda and observed that the firm was requested to furnish technical information vide letter dated 21.06.2010, but the same have not been received and norms can not be fixed in absence of the required information. It was, accordingly, decided to reject the case. 38
Case No.:29/38/82ALC4/2009
Party Name:PARABOLIC DRUGS LTD., 05.10.2010 Status:Case Deferred HQ File :01/82/050/00802/AM10/ RLA File :05/24/040/00383/AM10/ Lic.No/Date:0510253942 04.12.2009 Defer Date:30.11.2010 Decision : Committee considered case as per agenda and observed that the required information has been received from the firm and a copy of reply alongwith a copy of application has been sent to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 30.11.2010. 39
Case No.:113/46/82ALC4/2009
Party Name:MATRIX LABORATORIES LTD Status:Case
05.10.2010 Deferred HQ File :01/82/050/01029/AM10/ RLA File :09/24/040/00216/AM10/ Lic.No/Date:0910040167 04.12.2009 Defer Date:30.11.2010 Decision :Committee considered case as per agenda and observed that the firm was requested to furnish revised application which has been received. It was, therefore, decided to furnish a copy of revised application to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 30.11.2010. 40
Case No.:49/46/82ALC4/2009
Party Name:MAHAVIR INTERMEDIATES 05.10.2010 Status:Case Rejected HQ File :01/82/050/00965/AM10/ RLA File :52/24/040/00018/AM10/ Lic.No/Date:5210029042 07.12.2009 Decision : Committee considered case as per agenda and observed that the firm was requested to furnish technical information vide Department of C&PC letter No.14010/45/2010Ch.II dated 20.07.2010, but the same have not been received and norms can not be fixed in absence of the required information. It was, accordingly, decided to reject the case. 41
Case No.:73/46/82ALC4/2009
Party Name:YASHO INDUSTRIES PVT.LTD. 05.10.2010 Status:Case Deferred HQ File :01/82/050/00989/AM10/ RLA File :03/95/040/00575/AM10/ Lic.No/Date:0310550407 11.12.2009 Defer Date:30.11.2010 42
Case No.:79/9/82ALC4/2010
Party Name:MANTENA LABORATORIES LIMITED 05.10.2010 Status:Case Approved HQ File :01/82/050/00294/AM11/ RLA File :09/24/040/00350/AM10/ Lic.No/Date:0910040204 14.12.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/66/2010‐PI (Norms) dated 01.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed 1,2Epoxy2(2,4 Difluorophenyl)3(1 (H)Triazole1YL) Propane Methane Sulphonate 1 Kg. 1. 1,3Difluoro Benzene 0.65 kg 2. Dichloro Methane 1.25 kg 3. Acetonitrile 1.00 kg 4. Ethylene Dichloride 1.25 kg
43
Case No.:82/9/82ALC4/2010
Party Name:MANTENA LABORATORIES LIMITED 05.10.2010 Status:Case Approved HQ File :01/82/050/00297/AM11/ RLA File :09/24/040/00353/AM10/ Lic.No/Date:0910040205 14.12.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/66/2010‐PI (Norms) dated 01.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed 1,2Epoxy2(2,4 Difluorophenyl)3(1 (H)Triazole1YL) Propane Methane Sulphonate 1 Kg. 1. 1,3Difluoro Benzene 0.65 kg 2. Dichloro Methane 1.25 kg 3. Acetonitrile 1.00 kg 4. Ethylene Dichloride 1.25 kg 44
Case No.:94/9/82ALC4/2010
LIMITED 05.10.2010 Status:Case Approved HQ File :01/82/050/00309/AM11/ RLA File :09/24/040/00342/AM10/ Lic.No/Date:0910040200 14.12.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/69/2010‐PI (Norms) dated 05.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Cefepime for Injection/Cefepime Hcl Sterile (Buffered with LArginine) 1 Kg. 1. “(6R.7R)7[(Z)2(2Amino4 Thiazolyl)2Methoxyimino) Acetamido]3[1(1 Methylpy4rrolidinyl) Methyl)8oxo5 thia1azabicyclo[4.2.0]oct2en 2Carboxylic Acid Hydrochloride Monohydrate” (Cefepime Hcl non sterile) 0.655 kg 2. LArginine 0.37 kg 3. Acetone 1.816 kg 4. Methanol 1.134 kg 5. Activated Carbon 0.034 kg 6. Aluminium Canisters As per packing policy
45
Case No.:14/40/82ALC4/2009
05.10.2010 Status:Case Deferred HQ File :01/82/050/00829/AM10/ RLA File :03/94/040/00513/AM10/ Lic.No/Date:0310551191 16.12.2009 Defer Date:30.11.2010 46
Case No.:62/5/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 05.10.2010 Status:Case Deferred HQ File :01/82/050/00096/AM11/ RLA File :09/24/040/00321/AM10/ Lic.No/Date:0910040280 16.12.2009 Defer Date:30.11.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/63/2010PI (Norms) dated 05.10.2010, decided to call for the following information from the firm: 1. Step wise complete chemical reacĕon showing Molecular weight of each input and output producĕon and their molar requirement. 2. % yield on molar basis for each step. 3. Requirement and recovery of solvent on each step. 4. Technical literature in support of yields envisaged, and 5. Actual past producĕon and consumpĕon data duly cerĕfied by Central Excise Authority. 47
Case No.:36/46/82ALC4/2009
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 05.10.2010 Status:Case Deferred HQ File :01/82/050/00952/AM10/ RLA File :07/24/040/00356/AM10/ Lic.No/Date:0710069013 21.12.2009 Defer Date:30.11.2010 48
Case No.:83/46/82ALC4/2009
Party Name:EUROLIFE HEALTHCARE PVT. LTD. 05.10.2010 Status:Case Deferred HQ File :01/82/050/00999/AM10/ RLA File :03/94/040/00805/AM10/ Lic.No/Date:0310552288 23.12.2009 Defer Date:30.11.2010 Decision: Committee decided to defer case for 30.11.2010 for comments of Department of Pharmaceuticals. 49
Case No.:67/9/82ALC4/2010
Party Name:HETERO LABS LTD. 05.10.2010 Status:Case Deferred HQ File :01/82/050/00282/AM11/ RLA File :09/24/040/00393/AM10/ Lic.No/Date:0910040408 23.12.2009 Defer Date:16.11.2010 Decision : Commiĥee considered case as per agenda and observed that the case was earlier considered in 25/82 meeĕng held on 21.09.2010 and it was decided to call for the following informaĕon from the firm and defer the case for 16.11.2010:‐
1. Cerĕficate of Analysis from foreign supplier for import item ‘3‐Azido‐3‐Deoxy Thymidine’; and 2. Pharma specificaĕon for export item. Accordingly, case was deferred for 16.11.2010. 50
Case No.:96/9/82ALC4/2010
LIMITED 05.10.2010 Status:Case Approved HQ File :01/82/050/00311/AM11/ RLA File :09/24/040/00391/AM10/ Lic.No/Date:0910040412 23.12.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/69/2010‐PI (Norms) dated 05.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Cefdinir 1 Kg. 1. Acetone 13.12 kg 2. (Z)2(2Amino4Thiazp;u;)2Hydroxyimino Acetic Acid Ethyl Ester (ATHAET) 1.07 kg 3. Activated Carbon (Carbon Enoanticromos) 0.100 kg 4. Dimethyl formamide 0.865 kg 5. GCLE 2.44 kg 6. Iodine 0.094 kg 7. Methanol 4.68 kg 8. Methylene Chloride 16.88 kg 9. Phenol 2.751 kg 10. Potassium Carbonate 0.637 kg 11. Tetrahydrofuran (THF) 2.34 kg 12. Trifluoro Acetic Acid 0.020 kg 13. Triphenyl Phosphine 2.037 kg 14. Triethylamine 0.962 kg 51
Case No.:84/9/82ALC4/2010
Party Name:DR REDDYS LABORATORIES LTD 05.10.2010 Status:Case Approved HQ File :01/82/050/00299/AM11/ RLA File :09/24/040/00318/AM10/ Lic.No/Date:0910040461 30.12.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/79/2010‐PI (Norms) dated 01.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed
Finasteride Form III 1 Kg. 1. 3oxo4aza5aandrostane17bCarboxylic Acid 1.90 kg 2. BSTFA (Bis(Trimethylsilyl)Trifluoro Acetamide) 1.47 kg 3. DDQ (2,3Dichloro5,6Dicyano Benzo Quinone) 0.86 kg 4. Methylene Chloride 16.90 kg 5. Tetrahydrofuran 0.43 kg 6. Methanol 2.22 kg 52
Case No.:43/9/82ALC4/2010
Party Name:HETERO LABS LTD. 05.10.2010 Status:Case Approved HQ File :01/82/050/00258/AM11/ RLA File :09/24/040/00405/AM10/ Lic.No/Date:0910040496 01.01.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/68/2010‐PI (Norms) dated 05.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Irbesartan 1 Kg. 1. 2nbutyl1,3diazaspiro(4,4)non1en4one Hcl 0.88 kg 2. N(Triphenylmethyl)5(4bromomethylbiphenyl 2yl) tetrazole 92% 2.28 kg 3. Toluene 0.760 kg 4. Methylene Chloride 4.44 kg 53
Case No.:66/9/82ALC4/2010
Party Name:HETERO LABS LTD. 05.10.2010 Status:Case Deferred HQ File :01/82/050/00281/AM11/ RLA File :09/24/040/00404/AM10/ Lic.No/Date:0910040497 01.01.2010 Defer Date:30.11.2010 Decision : Commiĥee considered case as per agenda and in consultaĕon with representaĕve of Department of Pharmaceuĕcals decided to call for the following informaĕon from the firm:‐ 1. Cerĕficate of Analysis from foreign supplier for import item ‘3‐Azido‐3‐Deoxy Thymidine’; and 2. Pharma specificaĕon for export item. 54
Case No.:34/5/82ALC4/2010
Party Name:AVA CHEMICALS PVT.LTD., Status:Case
05.10.2010 Approved HQ File :01/82/050/00068/AM11/ RLA File :03/94/040/00778/AM10/ Lic.No/Date:0310554129 07.01.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/110/2007‐Ch.II dated 17.05.2010 and U.O. No.14010/110/2007/Ch.II dated 14.06.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Disodium Zinc EDTA (Zinc content 1415%) 1 Kg. 1. Ethylene Diamine Tetra Acetic Acid (EDTA) 0.690 kg Zinc Diammonium EDTA Liquid Zinc content 9% (+1) 1 Kg. 1. Ethylene Diamine Tetra Acetic Acid (EDTA) 0.422 kg 55
Case No.:9/43/82ALC4/2009
Party Name:RA CHEM PHARMA LIMITED 05.10.2010 Status:Case Rejected HQ File :01/82/050/00883/AM10/ RLA File :09/24/040/00354/AM10/ Lic.No/Date:0910040592 12.01.2010 Decision :Committee considered case as per agenda and observed that the firm was requested to clarify that the description of export product does not match with the export product given in the Drug Manufacturing Licence, but no reply has been received and norms can not be fixed in absence of the required information. It was, therefore, decided to reject the case. 56
Case No.:11/43/82ALC4/2009
Party Name:CADILA HEALTHCARE LTD., 05.10.2010 Status:Case Approved HQ File :01/82/050/00885/AM10/ RLA File :08/24/040/00277/AM10/ Lic.No/Date:0810085697 12.01.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/108/2010‐PI (Norms) dated 05.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Divalproex Sodium Sprinkle 125 mg Capsule 1 No. 1. Divalproex Sodium 134.625 mg 2. Hypermellose 3 CPS 12.688 kg 3. Methacrylic Acid Copoly Dipersion 184.25 kg 4. Microcrystalline Cellulose Spheres) 89.667 kg 5. Triethyl Citrate 5.583 kg 6. Bottles & Caos (A to E) As per packing policy
57
Case No.:77/9/82ALC4/2010
LIMITED 05.10.2010 Status:Case Approved HQ File :01/82/050/00292/AM11/ RLA File :09/24/040/00401/AM10/ Lic.No/Date:0910040590 12.01.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/69/2010‐PI (Norms) dated 05.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Lopinavir 1 Kg. 1. LPhenyl Alanine 0.710 kg 2. LValine 0.761 kg 3. Methane Sulphonic Acid 1.867 kg 4. Mono Ethylene Glycol Dimethyl Ether (Monoglyme) 14.746 kg 5. nHeptane 4.348 kg 6. Trifluoro Acetic Acid 1.816 kg 7. Methyl Tertiary Butyl Ether (MTBE) 6.421 kg 8. Potassium Carbonate (Anhydrous) 1.368 kg 9. Sodium Boro Hydride 0.819 kg 10. LPyro Glutamic Acid 0.316 kg 11. 2,6 Xylenol (2,6 Dimethyl Phenol) 0.618 kg 12. NNCarbonyl Di Imidazole 0.647 kg 13. Activated Carbon (Carbon Enoanticromos) 0.100 kg 14. Acetonitrile 0.195 kg 15. Dimethyl Formamide 3.72 kg 16. Isopropyl Alcohol 6.603 kg 17. Methanol 13.184 kg 18. Methylene Chloride 8.457 kg 19. Tetrahydrofuran 9.034 kg 20. Steam/Thermal Coal As per packing policy 58
Case No.:6/2/82ALC4/2010
Party Name:STERLING AUXILIARIES PVT LTD 05.10.2010 Status:Case Approved HQ File :01/82/050/00006/AM11/ RLA File :03/95/040/00677/AM10/ Lic.No/Date:0310555187 13.01.2010
Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/10/2010‐Ch.II dated 04.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed STERO AEEA (Amino Ethyl EthanolAmine) 1 Kg. 1. Ethylene Di Amine 0.588 kg 2. Ethylene Oxide 0.431 kg STERO TRS 20 (Sodium Salt of Iso Tri Decanol 13 moles Ethoxylated Sulphonate 70%) 1 kg. 1. Iso Tri Decanol (ITDA) 0.163 kg 2. Ethylene Oxide 0.467 kg STEROL 132570 (Iso Tri Decanol 12 mole Ethoxylate 85%) 1 kg. 1. Iso Tri Decanol (ITDA) 0.238 kg 2. Ethylene Oxide 0.628 kg STEROL 120G (BG) (Fatty Alcohol Poly Glycol Ether/Lauryl Alcohol 4.5 mole Ethoxylated) 1 kg 1. Lauryl Alcohol 0.504 kg 2. Ethylene Oxide 0.515 kg STEROL 161811 (Cetostearyl Alcohol Poly Glycol Ether/Cetostearyl Alcohol 10 mole Ethoxylated) 1 kg. 1. Ceto Stearyl Alcohol 0.375 kg 2. Ethylene Oxide 0.644 kg STEROL CO 100 (Polyethylene Triglyceride Ricinoleic Acid 15 mole Ethoxylated 1 kg. 1. Ethylene Oxide 0.423 kg STEROL CO 400 (Polyethylene Triglyceride Ricinoleic Acid 50 mole Ethoxylated 1 kg. 1. Ethylene Oxide 0.716 kg 59
Case No.:23/9/82ALC4/2010
Party Name:GLENMARK GENERICS LIMITED 05.10.2010 Status:Case Approved HQ File :01/82/050/00238/AM11/ RLA File :03/94/040/00826/AM10/ Lic.No/Date:0310555276 14.01.2010 Defer Date: Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/84/2010‐PI (Norms) dated 01.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Olmesartan Medoxomill 1 Kg. 1. 4(1Hydroxy1MethylEthyl)2Propyl1H Imidazole 5Carboxylic Acid Ethyl Ester 0.78 kg 2. 5(4Bromomethyl)(1,1Bromomethyl)2YL Triphenyl1H Tetrazole 1.81 kg 3. 4Chloromethyl5Methyl1,3dioxolen2one 0.48 kg 4. Dimethyl Formamide 6.72 kg
Tetrahydrofuran 3.43 kg 6. Potassium Carbonate 0.57 kg 7. Toluene 2.41 kg 60
Case No.:18/5/82ALC4/2010
05.10.2010 Status:Case Deferred HQ File :01/82/050/00052/AM11/ RLA File :03/94/040/00795/AM10/ Lic.No/Date:0310555546 15.01.2010 Defer Date:30.11.2010 61
Case No.:21/5/82ALC4/2010
Party Name:LAFFANS PETROCHEMICALS LTD., 05.10.2010 Status:Case Deferred HQ File :01/82/050/00055/AM11/ RLA File :03/95/040/00663/AM10/ Lic.No/Date:0310555780 18.01.2010 Defer Date:30.11.2010 Decision :Committee decided to forward a copy of Application to Petrochemicals Division of Department of C&PC for their comments. Accordingly, case was deferred for 30.11.2010. 62
Case No.:84/5/82ALC4/2010
Party Name:SAURAV CHEMICALS LTD, 05.10.2010 Status:Case Deferred HQ File :01/82/050/00118/AM11/ RLA File :22/24/040/00047/AM10/ Lic.No/Date:2210009594 19.01.2010 Defer Date:30.11.2010 Decision :Committee decided to defer case for 30.11.2010 for comments of Department of Pharmaceuticals. 63
Case No.:16/45/82ALC4/2009
Party Name:RA CHEM PHARMA LIMITED 05.10.2010 Status:Case Approved HQ File :01/82/050/00911/AM10/ RLA File :09/24/040/00364/AM10/ Lic.No/Date:0910040620 20.01.2010 Decision :Withdrawn as the case has already been approved by NC in its 23/82 meeting held on 07.09.2010. 64
Case No.:26/9/82ALC4/2010
Party Name:ENALTEC LABS PVT.LTD. 05.10.2010 Status:Case Approved HQ File :01/82/050/00241/AM11/ RLA File :03/94/040/00896/AM10/ Lic.No/Date:0310556539 21.01.2010 Decision : Withdrawn as the case has already been approved by NC in its 25/82 meeting held on 21.09.2010. 65
Case No.:25/9/82ALC4/2010
Party Name:ELPPE CHEMICALS PRIVATE Status:Case
LIMITED 05.10.2010 Deferred HQ File :01/82/050/00240/AM11/ RLA File :03/94/040/00912/AM10/ Lic.No/Date:0310556696 22.01.2010 Defer Date:30.11.2010 Decision :Committee decided to defer case for 30.11.2010 for comments of Department of C&PC. 66
Case No.:59/9/82ALC4/2010
Party Name:ELPPE CHEMICALS PRIVATE LIMITED 05.10.2010 Status:Case Approved HQ File :01/82/050/00274/AM11/ RLA File :03/94/040/00890/AM10/ Lic.No/Date:0310556699 22.01.2010 Decision :Withdrawn as the case has already been approved by NC in its 25/82 meeting held on 21.09.2010. 67
Case No.:38/5/82ALC4/2010
Party Name:MSN PHARMACHEM PRIVATE LIMITED 05.10.2010 Status:Case Deferred HQ File :01/82/050/00072/AM11/ RLA File :09/24/040/00359/AM10/ Lic.No/Date:0910040696 28.01.2010 Defer Date:19.10.2010 Decision :Withdrawn as the case has already been considered by NC in its 25/82 meeting held on 21.09.2010 and it has been decided to call the firm for personal hearing on 19.10.2010. 68
Case No.:40/5/82ALC4/2010
Party Name:MSN LABORATORIES LIMITED Meet No/Date:27/82ALC4/2010 05.10.2010 Status:Case Deferred HQ File :01/82/050/00074/AM11/ RLA File :09/24/040/00427/AM10/ Lic.No/Date:0910040698 28.01.2010 Defer Date:19.10.2010 Decision : Committee decided to defer case for 19.10.2010 for comments of Department of Pharmaceuticals. 69
Case No.:81/5/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 05.10.2010 Status:Case Deferred HQ File :01/82/050/00115/AM11/ RLA File :09/24/040/00390/AM10/ Lic.No/Date:0910040690 28.01.2010 Defer Date:30.11.2010 Decision :Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/63/2010PI (Norms) dated 05.10.2010, decided to call for the following information from the firm: 6. Step wise complete chemical reacĕon showing Molecular weight of each input and output producĕon and their molar requirement. 7. % yield on molar basis for each step. 8. Requirement and recovery of solvent on each step. 9. Technical literature in support of yields envisaged, and 10. Actual past producĕon and consumpĕon data duly cerĕfied by Central Excise Authority.
70
Case No.:24/9/82ALC4/2010
Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 05.10.2010 Status:Case Approved HQ File :01/82/050/00239/AM11/ RLA File :03/94/040/00871/AM10/ Lic.No/Date:0310557308 28.01.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/83/2010‐PI (Norms) dated 01.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Lumefantrine 1 Kg. 1. 2,7Dichloro Fluorene 1.134 kg 2. Chloro Acetyl Chloride 0.64 kg 3. Sodium Borohydride 0.07 kg 4. DiNButyl Amine 1.23 kg 5. 4Chloro Benzaldehyde 0.42 kg 6. NButanol 9.38 kg 71
Case No.:117/9/82ALC4/2010
Party Name:CHEMPRO EXPORTS (INDIA) 05.10.2010 Status:Case Approved HQ File :01/82/050/00332/AM11/ RLA File :03/94/040/00910/AM10/ Lic.No/Date:0310557320 28.01.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/15/2007‐Ch.II dated 22.09.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Dehydro ThioPara Toluidine Sulfonic Acid 1 Kg. 1. Para Toluidine 1.852 kg 72
Case No.:14/9/82ALC4/2010
Party Name:AVA CHEMICALS PVT.LTD., 05.10.2010 Status:Case Approved HQ File :01/82/050/00229/AM11/ RLA File :03/94/040/00924/AM10/ Lic.No/Date:0310557720 29.01.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/110/2007‐Ch.II dated 14.06.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by
Export product Exp. Qty. Sl.No. Import items Qty. allowed Diethylene Triamine Penta Acetic Acid (DTPA Acid) 1 Kg. 1. Diethylene Triamine 0.393 kg 73
Case No.:81/9/82ALC4/2010
Party Name:MSN PHARMACHEM PRIVATE LIMITED 05.10.2010 Status:Case Deferred HQ File :01/82/050/00296/AM11/ RLA File :09/24/040/00429/AM10/ Lic.No/Date:0910040725 29.01.2010 Defer Date:30.11.2010 Decision :Committee decided to defer case for 30.11.2010 for comments of Department of Pharmaceuticals. 74
Case No.:49/5/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 05.10.2010 Status:Case Approved HQ File :01/82/050/00083/AM11/ RLA File :09/24/040/00314/AM10/ Lic.No/Date:0910040762 01.02.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/71/2010‐PI (Norms) dated 05.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Clindamycin Palmitate Hcl 1 Kg. 1. Cyclohexane 0.814 kg 2. Palmitoyl Chloride 1.227 kg 3. Methanol 0.543 kg 4. Acetonitrile 6.33 kg 5. Dimethyl Formamide 0362 kg 6. Clindamycin Hcl 1.288 kg 75
Case No.:39/5/82ALC4/2010
Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 05.10.2010 Status:Case Deferred HQ File :01/82/050/00073/AM11/ RLA File :03/95/040/00654/AM10/ Lic.No/Date:0310558977 08.02.2010 Defer Date:30.11.2010 Decision :Committee decided to defer case for 30.11.2010 for comments of Department of Biotechnology. 76
Case No.:37/9/82ALC4/2010
Party Name:HETERO LABS LIMITED 05.10.2010 Status:Case Approved HQ File :01/82/050/00252/AM11/ RLA File :09/24/040/00468/AM10/ Lic.No/Date:0910040869
09.02.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/68/2010‐PI (Norms) dated 05.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Lamivudine (Purity NLT 99.8%) 1 Kg. 1. (2RCis)4Amino1(2Hydroxy Methyl)1,3 Oxathiolan5YL2(!H)Pyrimidinone 1.10 kg 2. Salicylic Acid 0.395 kg 3. Dimethyl Formamide 0.29 kg 4. Methanol 2.51 kg 5. Isopropyl Alcohol 0.35 kg 77
Case No.:83/9/82ALC4/2010
Party Name:APITHECARY PHARMA PVT LTD. 05.10.2010 Status:Case Approved HQ File :01/82/050/00298/AM11/ RLA File :09/24/040/00425/AM10/ Lic.No/Date:0910040885 10.02.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/80/2010‐PI (Norms) dated 01.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed (2RCis)5(4 Amino1,2 Hihydro2oxo 1 Pyrimidinyl)1,3 Oxathiolane2 Carboxylic Acid (2S,5R)Methyl Ester 1 Kg. 1. Glyoxalic Acid (50%) 0.90 kg 2. Sulphuric Acid Non importable item hence not allowed 3. Formaldehyde 0.546 kg 4. Sodium Bi Sulphite 0.658 kg 5. Sodium Carbonate 0.125 kg 6. Cyclo Hexane 0.86 kg 7. 2,5 Dehydroxy1,4Diethane 0.365 kg 8. Acetic Acid 0.100 kg 9. Triethylamine 0.67 kg 10. Di Methyl Formamide 0.23 kg 11. Hexa Methyl Di Silizane 0.75 kg 12. Thionyl Chloride 0.59 kg 13. Methane Sulphonic Acid 0.01 kg 14. Cytosine 0.455 kg 15. Hyflow Not a raw material. Hence not allowed 16. Toluene 1.82 kg
NHexane 3.00 kg 18. Ethyl Acetate 1.22 kg 19. Methylene Di Chloride 2.03 kg 78
Case No.:63/9/82ALC4/2010
Party Name:KOPRAN LIMITED 05.10.2010 Status:Case Approved HQ File :01/82/050/00278/AM11/ RLA File :03/94/040/00936/AM10/ Lic.No/Date:0310559797 11.02.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/77/2010‐PI (Norms) dated 01.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Pregabalin 1 Kg. 1. (+) 3(Carbamoylmethyl)5Methylhexanoic Acid 2.94 kg 79
Case No.:68/5/82ALC4/2010
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 05.10.2010 Status:Case Deferred HQ File :01/82/050/00102/AM11/ RLA File :07/24/040/00438/AM10/ Lic.No/Date:0710070041 16.02.2010 Defer Date:30.11.2010 80
Case No.:27/2/83ALC1/2010
Party Name:ROHA DYE CHEM PVT. LIMITED, 05.10.2010 Status:Case Deferred HQ File :01/83/050/00027/AM11/ RLA File :03/95/040/00729/AM10/ Lic.No/Date:0310560702 17.02.2010 Defer Date:30.11.2010 81
Case No.:48/9/82ALC4/2010
Party Name:K R R DRUGS & INTERMEDIATES PVT LTD 05.10.2010 Status:Case Approved HQ File :01/82/050/00263/AM11/ RLA File :09/24/040/00385/AM10/ Lic.No/Date:0910040985 17.02.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M.
No.35011/74/2010‐PI (Norms) dated 05.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed 7Phenyl Acetamido3Vinyl Cephalosporanic Acid PMethoxy BenzylEster 1 Kg. 1. GCLE 1.274 kg 2. Triphenyl Phosphine 0.70 kg 82
Case No.:73/9/82ALC4/2010
05.10.2010 Status:Case Approved HQ File :01/82/050/00288/AM11/ RLA File :03/94/040/01012/AM10/ Lic.No/Date:0310560981 18.02.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/87/2010‐PI (Norms) dated 05.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Dicyclomine Hydrochloride, Dried Aluminium Hydroxide Gel Light Magnesium Oxide Oral Suspension/Gelumen Oral Suspension/Syrup 200 ml pack 1. Dicyclomene Hcl BP 0.105 gm 2. Dried Aluminium Hydroxide 4.536 gm 3. Compressed Aluminium Hudroxide Gel 19.488 gm 4. Light Magnesium Oxide BP 4.20 gm 83
Case No.:95/9/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 05.10.2010 Status:Case Approved HQ File :01/82/050/00310/AM11/ RLA File :09/24/040/00463/AM10/ Lic.No/Date:0910041043 22.02.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/58/2010‐PI (Norms) dated 01.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Tenofovir Disoproxil Fumarate 1 Kg. 1. Adenine (6 Amino Purine) 0.914 kg 2. (R) Propylene Carbonate 0.7938 kg 3. Diethyl PToluene Sulphonyloxy Methyl 2.025 kg
Phosphonate 4. Chloromethyl Iso Propyl Carbonate 2.0867 kg 5. Magnesium Tert Butoxide 0.536 kg 6. Hydrobromic Acid (48% w/w Aq. Solution) 6.54 kg 7. Triethylamine 1.028 kg 8. Dimethyl Formamide 2.04 kg 9. NMethyl Pyrrolidinone 3.92 kg 10. Methylene Chloride 8.82 kg 11. Acetone 0.71 kg 12. Iso Propyl Alcohol 4.65 kg 13. Cyclohexane 1.79 kg 84
Case No.:2/19/82ALC4/2010
Party Name:HETERO LABS LIMITED 05.10.2010 Status:Case Deferred HQ File :01/82/050/00587/AM11/ RLA File :09/24/040/00492/AM10/ Lic.No/Date:0910041056 24.02.2010 Defer Date:30.11.2010 Decision :Committee decided to call for a copy of application, copy of Advance Authorisation, copy of DML and technical details as per Appendix 33 from RA/firm. Accordingly, case was deferred for 30.11.2010. 85
Case No.:41/5/82ALC4/2010
LIMITED 05.10.2010 Status:Case Approved HQ File :01/82/050/00075/AM11/ RLA File :09/24/040/00503/AM10/ Lic.No/Date:0910041155 03.03.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/88/2010‐PI (Norms) dated 05.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Nevirapine Anhydrous/Nevirapine 1 Kg. 1. 2Chloro Nicotinic Acid 0.902 kg 2. Acetone 1.513 kg 3. Carbon Enoanticromos (Activated Carbon) 0.100 kg 4. Cyclohexane 1.109 kg 5. Cyclo Propylamine 0.57 kg 6. Diethylene Glycol Dimethyl Ether (Diglyme) 2.16 kg 7. Malano Nitrile 0.84 kg 8. Methanol 8.43 kg 9. Methylene Chloride 1.30 kg
Phosphorous Oxychloride 2.884 kg 11. Phosphorous Pentachloride 0.392 kg 12. Pyridine 0.47 kg 13. Steam/Thermal As per packing policy 86
Case No.:42/5/82ALC4/2010
LIMITED 05.10.2010 Status:Case Approved HQ File :01/82/050/00076/AM11/ RLA File :09/24/040/00502/AM10/ Lic.No/Date:0910041152 03.03.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/69/2010‐PI (Norms) dated 05.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Lopinavir 1 Kg. 1. LPhenyl Alanine 0.710 kg 2. LValine 0.761 kg 3. Methane Sulphonic Acid 1.867 kg 4. Mono Ethylene Glycol Dimethyl Ether (Monoglyme) 14.746 kg 5. nHeptane 4.348 kg 6. Trifluoro Acetic Acid 1.816 kg 7. Methyl Tertiary Butyl Ether (MTBE) 6.421 kg 8. Potassium Carbonate (Anhydrous) 1.368 kg 9. Sodium Boro Hydride 0.819 kg 10. LPyro Glutamic Acid 0.316 kg 11. 2,6 Xylenol (2,6 Dimethyl Phenol) 0.618 kg 12. NNCarbonyl Di Imidazole 0.647 kg 13. Activated Carbon (Carbon Enoanticromos) 0.100 kg 14. Acetonitrile 0.195 kg 15. Dimethyl Formamide 3.72 kg 16. Isopropyl Alcohol 6.603 kg 17. Methanol 13.184 kg 18. Methylene Chloride 8.457 kg 19. Tetrahydrofuran 9.034 kg 20. Steam/Thermal Coal As per packing policy
87
Case No.:70/9/82ALC4/2010
05.10.2010 Status:Case Approved HQ File :01/82/050/00285/AM11/ RLA File :03/94/040/01049/AM10/ Lic.No/Date:0310563301 08.03.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments of Department of Pharmaceuĕcals and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Lamivudine 1 Kg. 1. (2R,5S)5[4Acetamido2Oxo1(2H)Pyrimidinyl] 1,3Oxathiolan2YL Methyl Menthyl Carbonate 2.63 kg 88
Case No.:1/52/82ALC4/2009
Party Name:RA CHEM PHARMA LIMITED 05.10.2010 Status:Case Approved HQ File :01/82/050/01194/AM10/ RLA File :09/24/040/00488/AM10/ Lic.No/Date:0910041233 09.03.2010 Decision :Withdrawn as the case has already been approved by NC in its 25/82 meeting held on 21.09.2010. 89
Case No.:57/9/82ALC4/2010
Party Name:MAKSON INDUSTRIES PVT. LTD. 05.10.2010 Status:Case Deferred HQ File :01/82/050/00272/AM11/ RLA File :03/95/040/00799/AM10/ Lic.No/Date:0310563993 10.03.2010 Defer Date:30.11.2010 Decision :Committee decided to defer case for 30.11.2010 for comments of DC(MSME). 90
Case No.:56/9/82ALC4/2010
05.10.2010 Status:Case Approved HQ File :01/82/050/00271/AM11/ RLA File :03/94/040/01069/AM10/ Lic.No/Date:0310564080 11.03.2010 91
Case No.:31/9/82ALC4/2010
05.10.2010 Status:Case Approved HQ File :01/82/050/00246/AM11/ RLA File :03/94/040/01077/AM10/ Lic.No/Date:0310564818 15.03.2010 92
Case No.:5/9/82ALC4/2010
Party Name:AVA CHEMICALS PVT.LTD., Status:Case
05.10.2010 Approved HQ File :01/82/050/00220/AM11/ RLA File :03/94/040/01075/AM10/ Lic.No/Date:0310565589 19.03.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/110/2007‐Ch.II dated 14.06.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed DTPA Potassium (DTPA K 5Liquid) Active content= 40% + 1) 1 Kg. 1. Diethylene Triamine (DETA) 0.125 kg EDTA Diammonium (Liquid) Assay Min. 40% 1 Kg. 1. Ethylene Diamine Tetra Acetic Acid (EDTA) 0.377 kg EDTA Tetra AmmoniumLiquid Assay Min – 40% 1 kg. 1. Ethylene Diamine Tetra Acetic Acid (EDTA) 0.341 kg 93
Case No.:9/9/82ALC4/2010
Party Name:AVA CHEMICALS PVT.LTD., 05.10.2010 Status:Case Approved HQ File :01/82/050/00224/AM11/ RLA File :03/94/040/01087/AM10/ Lic.No/Date:0310565583 19.03.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/110/2007‐Ch.II dated 17.05.2010 and U.O. No.14010/110/2007/Ch.II dated 14.06.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Disodium Zinc EDTA (Zinc content 1415%) 1 Kg. 1. Ethylene Diamine Tetra Acetic Acid (EDTA) 0.690 kg Zinc Diammonium EDTA Liquid Zinc content 9% (+1) 1 Kg. 1. Ethylene Diamine Tetra Acetic Acid (EDTA) 0.422 kg Copper Diammonium EDTA – Liquid Copper content 9% (+1) 1 kg. 1. Ethylene Diamine Tetra Acetic Acid (EDTA) 0.436 kg 94
Case No.:20/9/82ALC4/2010
05.10.2010 Status:Case Approved HQ File :01/82/050/00235/AM11/ RLA File :03/94/040/01100/AM10/ Lic.No/Date:0310565614 19.03.2010 Decision :Committee considered case as per agenda and taking cue from SION A1931 and in consultation with representative of Department of Pharmaceuticals present in meeting decided to ratify norms under para 4.7 of HBP as applied by the firm with 2% wastage.
95
Case No.:71/9/82ALC4/2010
05.10.2010 Status:Case Approved HQ File :01/82/050/00286/AM11/ RLA File :03/94/040/01118/AM10/ Lic.No/Date:0310565867 22.03.2010 Decision :Withdrawn as the case has already been approved by NC in its 25/82 meeting held on 21.09.2010. 96
Case No.:93/9/82ALC4/2010
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 05.10.2010 Status:Case Deferred HQ File :01/82/050/00308/AM11/ RLA File :03/95/040/00826/AM10/ Lic.No/Date:0310566202 24.03.2010 Defer Date:30.11.2010 97
Case No.:90/9/82ALC4/2010
Party Name:BHARAT SERUMS & VACCINES LTD 05.10.2010 Status:Case Approved HQ File :01/82/050/00305/AM11/ RLA File :03/94/040/01113/AM10/ Lic.No/Date:0310566481 25.03.2010 Decision :Committee considered case as per agenda and taking cue from SION A269 and in consultation with representative of Department of Pharmaceuticals present in the meeting, decided to ratify norms under para 4.7 of HBP with 10% wastage. 98
Case No.:7/9/82ALC4/2010
Party Name:AVA CHEMICALS PVT.LTD., 05.10.2010 Status:Case Approved HQ File :01/82/050/00222/AM11/ RLA File :03/94/040/01093/AM10/ Lic.No/Date:0310567048 29.03.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/110/2007‐Ch.II dated 14.06.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Cobalt EDTA (Co content 13% +) 1 Kg. 1. Ethylene Diamine Tetra Acetic Acid (EDTA) 0.716 kg 99
Case No.:85/5/82ALC4/2010
Party Name:SAURAV CHEMICALS LTD, Status:Case
05.10.2010 Approved HQ File :01/82/050/00119/AM11/ RLA File :22/24/040/00057/AM10/ Lic.No/Date:2210009830 30.03.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/91/2010‐PI (Norms) dated 01.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Homatropine Methyl Bromide Synonyms N,Ndimethyl8 Azoniabicyclo(3.2.1)octane3yl)2 hydroxy2phenylacetate bromide C.A.S. No.80499 formula C6H4CH2Bro2N Quality 99% Purity 1 kg 1. Tropine 0.718 kg 2. DLMandelic Acid 0.862 kg 3. Methylene Dichloride 5.20 kg 4. Acetone 5.37 kg 100
Case No.:131/9/82ALC4/2010
Party Name:GODAVARI BIOREFINERIES LTD. 05.10.2010 Status:Case Approved HQ File :01/82/050/00346/AM11/ RLA File :03/94/040/01025/AM10/ Lic.No/Date:0310567684 31.03.2010 Decision :Withdrawn as the case has already been approved by NC in its 25/82 meeting held on 21.09.2010. 101
Case No.:107/5/82ALC4/2010
Party Name:VDH INTERNATIONAL 05.10.2010 Status:Case Approved HQ File :01/82/050/00141/AM11/ RLA File :05/24/040/00516/AM10/ Lic.No/Date:0510261663 01.04.2010 102 Case No.:106/5/82ALC4/2010 Party Name:DHANUKA LABORATORIES LTD. 05.10.2010 Status:Case Approved HQ File :01/82/050/00140/AM11/ RLA File :05/23/040/00169/AM10/ Lic.No/Date:0510261709 05.04.2010 Defer Date: Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/43/2010‐PI (Norms) dated 01.07.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Cefixime USP Powder 1 Kg. 1. 7AVCA 0.571 kg 2. Dimethyl Acetamide 1.936 kg
Mica Ester 1.11 kg 4. Ethyl Acetate 1.10 kg 5. Methylene Chloride 4.494 kg 103
Case No.:53/5/82ALC4/2010
Party Name:CADILA PHARMACEUTICALS LTD. 05.10.2010 Status:Case Deferred HQ File :01/82/050/00087/AM11/ RLA File :08/24/040/00004/AM11/ Lic.No/Date:0810088011 07.04.2010 Defer Date:30.11.2010 Decision :Committee considered case as per agenda and decided to call for Production and Consumption data certified by Central Excise Authority from the firm. 104
Case No.:118/9/82ALC4/2010
05.10.2010 Status:Case Approved HQ File :01/82/050/00333/AM11/ RLA File :03/94/040/00002/AM11/ Lic.No/Date:0310569755 16.04.2010 Defer Date: 105
Case No.:104/9/82ALC4/2010
05.10.2010 Status:Case Approved HQ File :01/82/050/00319/AM11/ RLA File :03/94/040/00073/AM11/ Lic.No/Date:0310570345 20.04.2010 106
Case No.:3/5/82ALC4/2010
Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 05.10.2010 Status:Case Approved HQ File :01/82/050/00037/AM11/ RLA File :03/94/040/01130/AM10/ Lic.No/Date:0310570607 21.04.2010 Defer Date: 107 Case No.:6/5/82ALC4/2010 Party Name:INTAS PHARMACEUTICALS LTD., 05.10.2010 Status:Case Approved HQ File :01/82/050/00040/AM11/ RLA File :08/24/040/00024/AM11/ Lic.No/Date:0810088431 22.04.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/98/2010‐PI (Norms) dated 01.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per
Export product Exp. Qty. Sl.No. Import items Qty. allowed Tarazosin Hcl Capsule 1.0 mg 1 No. 1. Tarazosin Hcl (Asdihydrate) USP 1.2109 mg 2. LACTOSE Monohydrate USNF (Impalpable) NF 30.0 mg 3. Lactose Monohydrate Spray Dired NF(A) 85.31 mg 4. Starch (Corn 400L) NF (A) 20.0 mg 5. Crospovidone USNF (IVAX) 9.0 mg 6. Talc USNF (IVAX) 3.0 mg 7. Magnesium Stearate (VEG) 1.50 mg 8. EHG Cap White OPAQUE (0999) Whitopaque3 As per packing policy 9. 33 MM PPCTC with T. Seal HS 130 PTDWADDMF As per packing policy 10. IG Silica Gel Canister (SORBCAP)DMF As per packing policy 11. 53 mm PPCTC with T. Seal HS130 PTDWAD DMF As per packing policy Tarazosin Hcl Capsule 2.0 mg 1 No. 1. Tarazosin Hcl (Asdihydrate) USP 2.4217 mg 2. LACTOSE Monohydrate USNF (Impalpable) NF 30.0 mg 3. Lactose Monohydrate Spray Dired NF(A) 84.12 mg 4. Starch (Corn 400L) NF (A) 20.0 mg 5. Crospovidone USNF (IVAX) 9.0 mg 6. Talc USNF (IVAX) 3.0 mg 7. Magnesium Stearate (VEG) 1.50 mg 8. EHG Cap White OPAQUE (0999) Whitopaque3 As per packing policy 9. 33 MM PPCTC with T. Seal HS 130 PTDWADDMF As per packing policy 10. IG Silica Gel Canister (SORBCAP)DMF As per packing policy 11. 53 mm PPCTC with T. Seal HS130 PTDWAD DMF As per packing policy Tarazosin Hcl Capsule 5.0 mg 1 No. 1. Tarazosin Hcl (Asdihydrate) USP 6.0544 mg 2. LACTOSE Monohydrate USNF (Impalpable) NF 30.0 mg 3. Lactose Monohydrate Spray Dired NF(A) 80.55 mg 4. Starch (Corn 400L) NF (A) 20.0 mg 5. Crospovidone USNF (IVAX) 9.0 mg 6. Talc USNF (IVAX) 3.0 mg 7. Magnesium Stearate (VEG) 1.50 mg 8. EHG Cap White OPAQUE (0999) Whitopaque3 As per packing policy
33 MM PPCTC with T. Seal HS 130 PTDWADDMF As per packing policy 10. IG Silica Gel Canister (SORBCAP)DMF As per packing policy 11. 53 mm PPCTC with T. Seal HS130 PTDWAD DMF As per packing policy Tarazosin Hcl Capsule 10.0 mg 1 No. 1. Tarazosin Hcl (Asdihydrate) USP 12.1087 mg 2. LACTOSE Monohydrate USNF (Impalpable) NF 30.0 mg 3. Lactose Monohydrate Spray Dired NF(A) 74.60 mg 4. Starch (Corn 400L) NF (A) 20.0 mg 5. Crospovidone USNF (IVAX) 9.0 mg 6. Talc USNF (IVAX) 3.0 mg 7. Magnesium Stearate (VEG) 1.50 mg 8. EHG Cap White OPAQUE (0999) Whitopaque3 As per packing policy 9. 33 MM PPCTC with T. Seal HS 130 PTDWADDMF As per packing policy 10. IG Silica Gel Canister (SORBCAP)DMF As per packing policy 11. 53 mm PPCTC with T. Seal HS130 PTDWAD DMF As per packing policy 108
Case No.:121/9/82ALC4/2010
05.10.2010 Status:Case Approved HQ File :01/82/050/00336/AM11/ RLA File :03/94/040/00082/AM11/ Lic.No/Date:0310570681 22.04.2010 109
Case No.:13/5/82ALC4/2010
Party Name:DR REDDYS LABORATORIES LTD 05.10.2010 Status:Case Approved HQ File :01/82/050/00047/AM11/ RLA File :09/24/040/00003/AM11/ Lic.No/Date:0910041794 23.04.2010 110
Case No.:102/9/82ALC4/2010
Party Name:CODEXIS LABORATORIES INDIA PVT.LTD, 05.10.2010 Status:Case Approved HQ File :01/82/050/00317/AM11/ RLA File :05/23/040/00011/AM11/ Lic.No/Date:0510263007 26.04.2010
Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/81/2010‐PI (Norms) dated 01.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed 4FCE(2Methyl1oxo Propyl)RoxoNBDiphenyl Benzene ButanamideDKT3 OR 4(4Fluorophenyl)2 Isobutyryl*D Iketone 1 Kg. 1. Methyl Iso Butyryl Acetate 0.706 kg 2. Methylene Chloride 1.77 kg 3. Iso Propyl Alcohol 1.10 kg 4. Methanol 0.26 kg 111
Case No.:4/10/82ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 05.10.2010 Status:Case Deferred HQ File :01/82/050/00357/AM11/ RLA File :08/24/040/00036/AM11/ Lic.No/Date:0810089052 18.05.2010 Defer Date:02.11.2010 Decision : Committee decided to defer case for 02.11.2010 for comments of Department of Pharmaceuticals. 112
Case No.:6/19/82ALC4/2010
Party Name:DIVIS LABORATORIES LTD., 05.10.2010 Status:Case Deferred HQ File :01/82/050/00591/AM11/ RLA File :09/24/040/00064/AM11/ Lic.No/Date:0910042200 01.06.2010 Defer Date:02.11.2010 Decision : Committee decided to defer case for 02.11.2010 for comments of Department of Pharmaceuticals. 113
Case No.:1/12/85ALC3/2010
Party Name:BALAJI AMINES LIMITED 05.10.2010 Status:Case Deferred HQ File :01/85/050/00035/AM11/ RLA File :31/24/040/00037/AM11/ Lic.No/Date:3110043498 08.06.2010 Defer Date:30.11.2010 114
Case No.:25/15/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 05.10.2010 Status:Case Deferred HQ File :01/82/050/00462/AM11/ RLA File :09/24/040/00118/AM11/ Lic.No/Date:0910042554 30.06.2010 Defer Date:30.11.2010 Decision : Committee noted that application has not been received and decided to defer case for 30.11.2010. 115
Case No.:74/15/82ALC4/2010
Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 05.10.2010 Status:Case Deferred
HQ File :01/82/050/00511/AM11/ RLA File :31/24/040/00042/AM11/ Lic.No/Date:3110043796 30.06.2010 Defer Date:30.11.2010 116
Case No.:76/15/82ALC4/2010
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 05.10.2010 Status:Case Deferred HQ File :01/82/050/00513/AM11/ RLA File :03/95/040/00120/AM11/ Lic.No/Date:0310581500 30.06.2010 Defer Date:30.11.2010 117
Case No.:90/22/82ALC4/2010
05.10.2010 Status:Case Approved HQ File :01/82/050/00743/AM11/ RLA File :03/94/040/00351/AM11/ Lic.No/Date:0310584095 19.07.2010 Defer Date: Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/87/2010‐PI (Norms) dated 05.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Qty. of Tenofovir Disoproxil Fumarate Sl.No. Import items Qty. allowed Tenofovir Disoproxil Fumarate Tablets 300 mg/Tenvir Tablets Tenofovir Disoproxil Fumarate = 306 mg/tablet 1 Kg. 1. 9(2(Phosphonyl Methoxy) Adenine (PMPA) 0.8026 kg 2. Chloromethyl Isopropyl Carbonate 2.0867 kg 3. NMethyl 2Pyrrolidone 3.297 kg 4. Fumaric Acid 0.304 kg 5. Methylene Dichloride 6.70 kg 6. Isopropyl Acetate 2.35 kg 118
Case No.:105/22/82ALC4/2010
Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 05.10.2010 Status:Case Approved HQ File :01/82/050/00758/AM11/ RLA File :03/94/040/00307/AM11/ Lic.No/Date:0310584083 19.07.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O.No.14010/83/2006‐Ch.II dated 22.07.08 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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
Ortho Terĕary Butyl Cyclohexyl Acetate/ Ortho Terĕary Butyl Cyclohexyl Acetate Super 1 KG. 1. Ortho Terĕary Butyl Phenol 0.820 kg 2. 5% Ruthenium on Carbon Catylyst 0.000015 kg 3. Aceĕc Anhydride 0.575 kg 4. Methanol 0.330 kg 119
Case No.:15/19/82ALC4/2010
Party Name:SRINI PHARMACEUTICALS LTD., 05.10.2010 Status:Case Deferred HQ File :01/82/050/00600/AM11/ RLA File :09/24/040/00136/AM11/ Lic.No/Date:0910042745 20.07.2010 Defer Date:30.11.2010 Decision :Committee decided to call for the copy of application, copy of Advance Authorisation, copy of DML and technical details as per Appendix 33 from RA/firm. Accordingly, case was deferred for 30.11.2010. 120
Case No.:16/19/82ALC4/2010
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 05.10.2010 Status:Case Deferred HQ File :01/82/050/00601/AM11/ RLA File :09/24/040/00135/AM11/ Lic.No/Date:0910042749 20.07.2010 Defer Date:30.11.2010 Decision :Committee decided to defer case for 30.11.2010 for reply from firm. 121
Case No.:20/19/82ALC4/2010
Party Name:HETERO LABS LIMITED 05.10.2010 Status:Case Approved HQ File :01/82/050/00605/AM11/ RLA File :09/24/040/00159/AM11/ Lic.No/Date:0910042763 20.07.2010 Decision :Committee decided to close the case as Advance Authorisation has been issued under para 4.7.1 of HBPas informed by the firm vide its letter dated 06.10.2010. 122
Case No.:22/19/82ALC4/2010
LIMITED 05.10.2010 Status:Case Deferred HQ File :01/82/050/00607/AM11/ RLA File :09/24/040/00131/AM11/ Lic.No/Date:0910042765 20.07.2010 Defer Date:30.11.2010 123 Case No.:23/19/82ALC4/2010 Party Name:HERBOCHEM 05.10.2010 Status:Case Deferred HQ File :01/82/050/00608/AM11/ RLA File :09/24/040/00127/AM11/ Lic.No/Date:0910042768 20.07.2010 Defer Date:30.11.2010
Decision :Committee considered case as per agenda and decided to remind DC(MSME), Department of C&PC and Department of Ayush for their comments. 124
Case No.:24/19/82ALC4/2010
Party Name:MSN LABORATORIES LIMITED Meet No/Date:27/82ALC4/2010 05.10.2010 Status:Case Deferred HQ File :01/82/050/00609/AM11/ RLA File :09/24/040/00143/AM11/ Lic.No/Date:0910042769 20.07.2010 Defer Date:30.11.2010 Decision :Committee decided to call for the copy of application, copy of advance authorization, copy of DML and technical details as per Appendix 33 from RA/firm. Accordingly, case was deferred for 30.11.2010. 125
Case No.:102/22/82ALC4/2010
Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. 05.10.2010 Status:Case Deferred HQ File :01/82/050/00755/AM11/ RLA File :31/24/040/00070/AM11/ Lic.No/Date:3110044017 20.07.2010 Defer Date:30.11.2010 126
Case No.:106/22/82ALC4/2010
Party Name:ENALTEC LABS PVT.LTD. 05.10.2010 Status:Case Deferred HQ File :01/82/050/00759/AM11/ RLA File :03/94/040/00303/AM11/ Lic.No/Date:0310584220 20.07.2010 Defer Date:30.11.2010 127
Case No.:25/19/82ALC4/2010
Party Name:NEULAND LABORATORIES LTD 05.10.2010 Status:Case Deferred HQ File :01/82/050/00610/AM11/ RLA File :09/24/040/00128/AM11/ Lic.No/Date:0910042800 21.07.2010 Defer Date:30.11.2010 128 Case No.:86/22/82ALC4/2010 05.10.2010 Status:Case Approved HQ File :01/82/050/00739/AM11/ RLA File :03/94/040/00368/AM11/ Lic.No/Date:0310584871 23.07.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/87/2010‐PI (Norms) dated 05.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Qty. of Tenofovir Disoproxil Fumarate Sl.No. Import items Qty. allowed
Tenofovir Disoproxil Fumarate Tablets 300 mg/Tenvir Tablets Tenofovir Disoproxil Fumarate = 306 mg/tablet 1 Kg. 1. 9(2(Phosphonyl Methoxy) Adenine (PMPA) 0.8026 kg 2. Chloromethyl Isopropyl Carbonate 2.0867 kg 3. NMethyl 2Pyrrolidone 3.297 kg 4. Fumaric Acid 0.304 kg 5. Methylene Dichloride 6.70 kg 6. Isopropyl Acetate 2.35 kg 129
Case No.:94/22/82ALC4/2010
Party Name:HONEST BIOVET PVT. LTD 05.10.2010 Status:Case Approved HQ File :01/82/050/00747/AM11/ RLA File :08/24/040/00132/AM11/ Lic.No/Date:0810090720 23.07.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/67/2010‐PI (Norms) dated 01.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Menadione Sodium Bisulphite Complex (containing Menadione Sodium Bisulphite NLT 65%) 1 Kg. 1. Menadione Sodium Bisulphite (Assay NMT 94%) 0.695 kg 130
Case No.:96/22/82ALC4/2010
Party Name:HONEST BIOVET PVT. LTD 05.10.2010 Status:Case Approved HQ File :01/82/050/00749/AM11/ RLA File :08/24/040/00133/AM11/ Lic.No/Date:0810090721 23.07.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/67/2010‐PI (Norms) dated 01.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Menadione Nicotinamide Bisulphite 1 Kg. 1. Menadione Sodium Bisulphite 94% 0.917 kg 2. Niacinamide 0.40 kg
131
Case No.:1/19/82ALC4/2010
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 05.10.2010 Status:Case Deferred HQ File :01/82/050/00586/AM11/ RLA File :07/24/040/00135/AM11/ Lic.No/Date:0710073163 26.07.2010 Defer Date:30.11.2010 Decision :Committee considered case as per agenda and decided to call for a copy of Drug Manufacturing Licence from the firm. Accordingly, case was deferred for 30.11.2010. 132
Case No.:9/19/82ALC4/2010
05.10.2010 Status:Case Deferred HQ File :01/82/050/00594/AM11/ RLA File :03/94/040/00308/AM11/ Lic.No/Date:0310584959 26.07.2010 Defer Date:30.11.2010 133
Case No.:11/19/82ALC4/2010
Party Name:DORFKETAL CHEMICALS INDIA PVT.LTD. 05.10.2010 Status:Case Deferred HQ File :01/82/050/00596/AM11/ RLA File :03/94/040/00379/AM11/ Lic.No/Date:0310585032 26.07.2010 Defer Date:30.11.2010 134
Case No.:12/19/82ALC4/2010
Party Name:DORFKETAL CHEMICALS INDIA PVT.LTD. 05.10.2010 Status:Case Deferred HQ File :01/82/050/00597/AM11/ RLA File :03/94/040/00378/AM11/ Lic.No/Date:0310585034 26.07.2010 Defer Date:30.11.2010 135
Case No.:40/19/82ALC4/2010
Party Name:PANACEA BIOTEC LTD., 05.10.2010 Status:Case Deferred HQ File :01/82/050/00625/AM11/ RLA File :05/24/040/00156/AM11/ Lic.No/Date:0510269042 26.07.2010 Defer Date:30.11.2010 Decision : Committee decided to defer case for 30.11.2010 for comments of Department of Biotechnology. 136
Case No.:8/19/82ALC4/2010
Party Name:SHASUN CHEMICALS & DRUGS LIMITED 05.10.2010 Status:Case Deferred HQ File :01/82/050/00593/AM11/ RLA File :04/24/040/00085/AM11/ Lic.No/Date:0410115832 27.07.2010 Defer Date:02.11.2010 Decision : Commiĥee decided to defer case for 02.11.2010 for comments of Department of Pharmaceuĕcals.
137 Case No.:33/19/82ALC4/2010 Party Name:HERBOCHEM 05.10.2010 Status:Case Deferred HQ File :01/82/050/00618/AM11/ RLA File :09/24/040/00153/AM11/ Lic.No/Date:0910042877 28.07.2010 Defer Date:30.11.2010 Decision :Committee considered case as per agenda and decided to remind DC(MSME), Department of C&PC and Department of Ayush for their comments. 138
Case No.:10/19/82ALC4/2010
Party Name:GOPINATH CHEMTECH LTD., 05.10.2010 Status:Case Deferred HQ File :01/82/050/00595/AM11/ RLA File :08/24/040/00126/AM11/ Lic.No/Date:0810090811 29.07.2010 Defer Date:30.11.2010 139
Case No.:35/19/82ALC4/2010
Party Name:DISCOVERY INTERMEDIATES PVT LTD. 05.10.2010 Status:Case Deferred HQ File :01/82/050/00620/AM11/ RLA File :09/24/040/00045/AM11/ Lic.No/Date:0910042935 29.07.2010 Defer Date:30.11.2010 Decision :Committee decided to call for a copy of application, copy of advance authorization, copy of DML and technical details as per Appendix 33 from RA/firm. 140
Case No.:36/19/82ALC4/2010
Party Name:MSN PHARMACHEM PRIVATE LIMITED 05.10.2010 Status:Case Deferred HQ File :01/82/050/00621/AM11/ RLA File :09/24/040/00160/AM11/ Lic.No/Date:0910042936 29.07.2010 Defer Date:30.11.2010 141
Case No.:41/19/82ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 05.10.2010 Status:Case Deferred HQ File :01/82/050/00626/AM11/ RLA File :05/24/040/00158/AM11/ Lic.No/Date:0510269343 29.07.2010 Defer Date:30.11.2010 142
Case No.:28/19/82ALC4/2010
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 05.10.2010 Status:Case Deferred HQ File :01/82/050/00613/AM11/ RLA File :03/95/040/00134/AM11/ Lic.No/Date:0310585530 30.07.2010 Defer Date:30.11.2010
143
Case No.:32/19/82ALC4/2010
Party Name:SHILPA MEDICARE LTD., 05.10.2010 Status:Case Deferred HQ File :01/82/050/00617/AM11/ RLA File :07/24/040/00137/AM11/ Lic.No/Date:0710073295 30.07.2010 Defer Date:30.11.2010 Decision :Committee considered case as per agenda for ratification of norms for the export product Gemcitabine Hcl and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/93/2010PI (Norms) dated 05.10.2010, decided to call for the following information from the firm: 1. Technicaljusĕficaĕon for such a lower yield of 11.66% in step VI of their reacĕon scheme. 2. Copy of technical literature in support of yield envisaged above. 3. Producĕon and consumpĕon data for the above export product for the past 3 years duly cerĕfied by Central Excise Authority. 144
Case No.:37/19/82ALC4/2010
Party Name:SAINOR LABORATORIES PVT LTD 05.10.2010 Status:Case Deferred HQ File :01/82/050/00622/AM11/ RLA File :09/24/040/00147/AM11/ Lic.No/Date:0910042939 30.07.2010 Defer Date:30.11.2010 145
Case No.:38/19/82ALC4/2010
Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 05.10.2010 Status:Case Approved HQ File :01/82/050/00623/AM11/ RLA File :09/24/040/00165/AM11/ Lic.No/Date:0910042940 30.07.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O.No.14010/107/2008‐Ch.II dated 04.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by Export Product Export Qty. Sl.No. Import items Qty. allowed Homosalate (3,3,5‐ Trimethyl Cyclohexyl Salicylate) 1 kg 1. 3,3,5‐Trimethyl Cyclohexanol 0.571 kg 2. Methyl Salicylate 0.610 kg 146
Case No.:39/19/82ALC4/2010
Party Name:NEULAND LABORATORIES LTD 05.10.2010 Status:Case Deferred HQ File :01/82/050/00624/AM11/ RLA File :09/24/040/00158/AM11/ Lic.No/Date:0910042941 30.07.2010 Defer Date:30.11.2010
147
Case No.:1/22/82ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 05.10.2010 Status:Case Deferred HQ File :01/82/050/00654/AM11/ RLA File :05/24/040/00171/AM11/ Lic.No/Date:0510270699 17.08.2010 Defer Date:30.11.2010 148
Case No.:2/22/82ALC4/2010
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 05.10.2010 Status:Case Deferred HQ File :01/82/050/00655/AM11/ RLA File :07/24/040/00171/AM11/ Lic.No/Date:0710073644 17.08.2010 Defer Date:30.11.2010 149
Case No.:3/22/82ALC4/2010
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 05.10.2010 Status:Case Deferred HQ File :01/82/050/00656/AM11/ RLA File :07/24/040/00168/AM11/ Lic.No/Date:0710073645 17.08.2010 Defer Date:30.11.2010 150
Case No.:39/22/82ALC4/2010
Party Name:UNICHEM LABORATORIES LIMITED 05.10.2010 Status:Case Deferred HQ File :01/82/050/00692/AM11/ RLA File :03/95/040/00365/AM11/ Lic.No/Date:0310588002 17.08.2010 Defer Date:30.11.2010 151
Case No.:40/22/82ALC4/2010
Party Name:S.R.S.PHARMACEUTICALS PVT. LTD. 05.10.2010 Status:Case Approved HQ File :01/82/050/00693/AM11/ RLA File :03/95/040/00305/AM11/ Lic.No/Date:0310588014 17.08.2010 Defer Date: Decision :Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per SION A412 with 2% wastage. 152 Case No.:41/22/82ALC4/2010 Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 05.10.2010 Status:Case Deferred HQ File :01/82/050/00694/AM11/ RLA File :03/95/040/00338/AM11/ Lic.No/Date:0310588148 17.08.2010 Defer Date:30.11.2010
153
Case No.:43/22/82ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 05.10.2010 Status:Case Deferred HQ File :01/82/050/00696/AM11/ RLA File :08/24/040/00159/AM11/ Lic.No/Date:0810091377 18.08.2010 Defer Date:30.11.2010 154
Case No.:44/22/82ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 05.10.2010 Status:Case Deferred HQ File :01/82/050/00697/AM11/ RLA File :08/24/040/00158/AM11/ Lic.No/Date:0810091380 18.08.2010 Defer Date:07.12.2010 Decision :Commiĥee decided to defer case for 07.12.2010 for comments of Department of Pharmaceuĕcals. 155
Case No.:45/22/82ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 05.10.2010 Status:Case Deferred HQ File :01/82/050/00698/AM11/ RLA File :08/24/040/00154/AM11/ Lic.No/Date:0810091381 18.08.2010 Defer Date:30.11.2010 156
Case No.:114/22/82ALC4/2010
Party Name:GALAXY SURFACTANTS LTD., 05.10.2010 Status:Case Approved HQ File :01/82/050/00767/AM11/ RLA File :03/94/040/00020/AM11/ Lic.No/Date:0310588363 18.08.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O.No.14010/16/2008‐Ch.II dated 05.03.2009 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Octyl Diphenyl Cyanoacrylate 1 kg 1. Methyl Cyanoacetate 0.289 kg 2. 2‐Ethyl Hexyl Alcohol 0.379 kg 3. Benzophenone 0.560 kg 157 Case No.:103/22/82ALC4/2010 Party Name:MEDREICH LIMITED 05.10.2010 Status:Case Approved HQ File :01/82/050/00756/AM11/ RLA File :07/24/040/00194/AM11/ Lic.No/Date:0710073685
19.08.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their U.O. No.35011/94/2009‐PI‐III dated 26.10.2009 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Clindamycin Capsules 150 mg 1 No. 1. Clindamycin Hcl BP 173.53 mg Clindamycin Capsules 300 mg 1 No. 1. Clindamycin Hcl BP 347.06 mg 158
Case No.:109/22/82ALC4/2010
Party Name:HETERO LABS LIMITED 05.10.2010 Status:Case Deferred HQ File :01/82/050/00762/AM11/ RLA File :09/24/040/00203/AM11/ Lic.No/Date:0910043139 19.08.2010 Defer Date:30.11.2010 159
Case No.:115/22/82ALC4/2010
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 05.10.2010 Status:Case Deferred HQ File :01/82/050/00768/AM11/ RLA File :03/95/040/00307/AM11/ Lic.No/Date:0310588444 19.08.2010 Defer Date:30.11.2010 160
Case No.:111/22/82ALC4/2010
Party Name:HETERO LABS LIMITED 05.10.2010 Status:Case Deferred HQ File :01/82/050/00764/AM11/ RLA File :09/24/040/00190/AM11/ Lic.No/Date:0910043160 20.08.2010 Defer Date:30.11.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/68/2010‐PI (Norms) dated 05.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Irbesartan 1 Kg. 1. 2nbutyl1,3diazaspiro(4,4)non1en4one Hcl 0.88 kg 2. N(Triphenylmethyl)5(4bromomethylbiphenyl 2yl) tetrazole 92% 2.28 kg 3. Toluene 0.760 kg 4. Methylene Chloride 4.44 kg
161
Case No.:112/22/82ALC4/2010
Party Name:VIJAYASRI ORGANICS LTD 05.10.2010 Status:Case Deferred HQ File :01/82/050/00765/AM11/ RLA File :09/24/040/00181/AM11/ Lic.No/Date:0910043179 20.08.2010 Defer Date:30.11.2010 162
Case No.:113/22/82ALC4/2010
Party Name:VIJAYASRI ORGANICS LTD 05.10.2010 Status:Case Deferred HQ File :01/82/050/00766/AM11/ RLA File :09/24/040/00180/AM11/ Lic.No/Date:0910043180 20.08.2010 Defer Date:30.11.2010 163
Case No.:21/23/82ALC4/2010
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 05.10.2010 Status:Case Deferred HQ File :01/82/050/00789/AM11/ RLA File :03/95/040/00328/AM11/ Lic.No/Date:0310589372 25.08.2010 Defer Date:30.11.2010 164 Case No.:2/27/82ALC4/2010 Party Name:AKZO NOBEL CHEMICALS (INDIA) LIMITED. 05.10.2010 Status:Case Approved HQ File :01/82/050/00869/AM11/ RLA File :31/24/040/00122/AM11/ Lic.No/Date:3110044708 21.09.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/315/2000‐Ch.III dated 15.11.2004 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by Export product Export Qty. Sl.No. Import items Qty allowed Trigonox‐EHP W50 bis (2‐ ethylhexyl) peroxydicarbonate (50%) 1 kg. 1. 2‐Ethyl hexyl chloroformae (2‐EHCF) 0.583 kg 2. Polyvinyl Alcohol 0.30 kg 3. Anĕ‐foaming agent (Dequest) 0.0005 kg 4. CONTAINER HDPE 30 LTR. LOOSE, WITH 2 LABELS 30 LTR, CR CANS, FROM HDPE, NATURAL, WITH K 60 OPENING AND RED K29 SCREW CAP, 6 PIECES IN PLASTIC BAG, INCLUDING CAPS As per packing policy 5. Screwcap K60 with Pregasket As per packing policy
165
Case No.:1/27/82ALC4/2010
Party Name:YASHO INDUSTRIES PVT.LTD. 05.10.2010 Status:Case Approved HQ File :01/82/050/00868/AM11/ RLA File :03/95/040/00498/AM11/ Lic.No/Date:0310593381 22.09.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/120/2002‐Ch.III dated 16.10.2006 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by Export product Export Qty. Sl.No. Import items Qty allowed Copper Dibutyl Dithiocarbamate 1 kg. 1. Dibutyl Amine 0.600 kg 166
Case No.:3/27/82ALC4/2010
Party Name:VIVIMED LABS LIMITED 05.10.2010 Status:Case Deferred HQ File :01/82/050/00870/AM11/ RLA File :09/24/040/00139/AM11/ Lic.No/Date:0910043602 23.09.2010 Defer Date:30.11.2010 167
Case No.:4/27/82ALC4/2010
Party Name:INTAS PHARMACEUTICALS LTD., 05.10.2010 Status:Case Approved HQ File :01/82/050/00871/AM11/ RLA File :08/24/040/00183/AM11/ Lic.No/Date:0810092438 23.09.2010 Decision :Committee decided to close the case as Advance Authorisation has been issued under para 4.7.1 of HBP. 168 Case No.:5/27/82ALC4/2010 Party Name:OCEAN PHARMA COAT PVT LTD. 05.10.2010 Status:Case Approved HQ File :01/82/050/00872/AM11/ RLA File :09/24/040/00222/AM11/ Lic.No/Date:0910043619 23.09.2010 Decision : Committee considered case as per agenda for ratification of norms and in light of its earlier decision taken in its 16/82 meeting held on 20.07.2010 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
Orlistat Pellets 50% 1 Kg. 1. Orlistat 0.505 kg 169
Case No.:6/27/82ALC4/2010
05.10.2010 Status:Case Deferred HQ File :01/82/050/00873/AM11/ RLA File :03/94/040/00561/AM11/ Lic.No/Date:0310593686 23.09.2010 Defer Date:30.11.2010 170
Case No.:7/27/82ALC4/2010
Party Name:VIVIMED LABS LIMITED 05.10.2010 Status:Case Deferred HQ File :01/82/050/00874/AM11/ RLA File :09/24/040/00129/AM11/ Lic.No/Date:0910043626 24.09.2010 Defer Date:30.11.2010 Decision :Committee decided to defer case for 30.11.2010 for comments of Department of Pharmaceuticals. 171
Case No.:8/27/82ALC4/2010
Party Name:VIVIMED LABS LIMITED 05.10.2010 Status:Case Deferred HQ File :01/82/050/00875/AM11/ RLA File :09/24/040/00105/AM11/ Lic.No/Date:0910043635 24.09.2010 Defer Date:30.11.2010 172 Case No.:9/27/82ALC4/2010 Party Name:AVON ORGANICS LTD., 05.10.2010 Status:Case Approved HQ File :01/82/050/00876/AM11/ RLA File :09/24/040/00243/AM11/ Lic.No/Date:0910043640 24.09.2010 Defer Date: Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/165/2009‐PI‐(Norms) dated 16.01.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Valacyclovir Hydrochloride 1 Kg. 1. Acyclovir 0.78 kg 2. NBenzyloxy CarbonylLValine 1.1824 kg 3. Dicyclohexyl Carbodimide 1.3871 kg 4. 4Dimethyl Amino Pyridine 0.028 kg 5. Dimethyl Formamide 3.515 kg 6. Methanol 3.156 kg 7. 5% Palladium on Charcoal 0.100 kg 8. Acetone 3.090 kg
Activated Carbon 0.0242 kg 10. Sodium Borohydride 0.38 kg RA concerned may take further necessary acĕon as per above decision of NC. 173
Case No.:10/27/82ALC4/2010
LIMITED 05.10.2010 Status:Case Deferred HQ File :01/82/050/00877/AM11/ RLA File :09/24/040/00242/AM11/ Lic.No/Date:0910043641 24.09.2010 Defer Date:30.11.2010 174
Case No.:11/27/82ALC4/2010
LIMITED 05.10.2010 Status:Case Approved HQ File :01/82/050/00878/AM11/ RLA File :09/24/040/00231/AM11/ Lic.No/Date:0910043642 24.09.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/88/2010‐PI‐(Norms) dated 05.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Nevirapine Anhydrous/Nevirapine 1 Kg. 1. 2Chloro Nicotinic Acid 0.902 kg 2. Acetone 1.513 kg 3. Carnon Enoanticromos (Activated Carbon) 0.100 kg 4. Cyclohexane 1.109 kg 5. Cyclo Propylamine 0.57 kg 6. Diethylene Glycol Dimethyl Ether (Diglyme) 2.16 kg 7. Malano Nitrile 0.84 kg 8. Methanol 8.43 kg 9. Methylene Chloride 1.30 kg 10. Phosphorus Oxychloride 2.884 kg 11. Phosphorus Pentachloride 0.392 kg 12. Pyridine 0.47 kg 13. Steam/Thermal coal As per packing policy 175 Case No.:12/27/82ALC4/2010 Party Name:METROPOLITAN EXIMCHEM LTD. 05.10.2010 Status:Case Deferred HQ File :01/82/050/00879/AM11/ RLA File :03/95/040/00490/AM11/ Lic.No/Date:0310593852 Defer
24.09.2010 Date:30.11.2010 176
Case No.:13/27/82ALC4/2010
Party Name:AMBUJA INTERMEDIATES PVT. LTD. 05.10.2010 Status:Case Approved HQ File :01/82/050/00880/AM11/ RLA File :03/94/040/00474/AM11/ Lic.No/Date:0310593858 24.09.2010 Defer Date: Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/1/2008/Ch.II dated 30.07.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed 2R Acid (2Amino8Naphthol3,6 Disulfonic Acid) 1 kg 1. K Acid 2.500 kg 177
Case No.:14/27/82ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 05.10.2010 Status:Case Deferred HQ File :01/82/050/00881/AM11/ RLA File :05/24/040/00228/AM11/ Lic.No/Date:0510273723 27.09.2010 Defer Date:30.11.2010 178
Case No.:15/27/82ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 05.10.2010 Status:Case Deferred HQ File :01/82/050/00882/AM11/ RLA File :05/24/040/00210/AM11/ Lic.No/Date:0510273747 27.09.2010 Defer Date:30.11.2010
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