DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi 0
Para 4.7 Decision(DRAFT)
MEETING NUMBER : 51/82ALC4/2010 MEETING DATE : 22.03.2011 The Meeting No.51/82 in the year 201011 to consider the cases under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to products falling in Chapter 29 and 30 scheduled to be held on 22.03.2011 was actually held on 24.03.2011 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present: 1. Shri Jasbir Singh, IA, Department of C&PC 2. Shri M. Mitra, Dy. DCGI, Office of DCGI 3. Shri D.N. Mathur, Dy.I.A, Department of Pharmaceuticals 4. Shri Krishan Kumar, Dy. DGFT 5. Shri Shyam Lal, FTDO
Case No.B428
M/S Shalina Laboratories Pvt. Ltd. Norms Committee Meeting No.51/11 F.No.01/82/050/00725/AM11/DESIII Meeting Date:22.03.2011 RA F.No.03/95/040/00214/AM11 Adv.Lic.No.0310582836 dated 09.07.2010 Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to enhance the quantity of Gentamycin Sulphate to the extent of 51.408 mg/30 mg tube without any other change in the decision taken in 26/82 meeting held on 28.09.2010. RA concerned may take further necessary action as per above decision of NC.
Case No.B429
M/S Chempro Exports (India) F.No.01/82/050/00409/AM11/DESIII RA F.No.03/94/040/00028/AM11 Adv.Lic.No.0310570620 dated 21.04.2010 Committee considered case as per agenda and in light of earlier decision taken in 27/82 meeting held on 05.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed Dehydro ThioPara Toluidine Sulfonic Acid 1 kg 1. Para Toluidine 1.852 kg
Case No.B430
M/S FMC India Pvt. Ltd.
F.No.01/83/050/01854/AM08/DESIII RA F.No.07/24/040/00727/AM07 Adv.Lic.No.0710049839 dated 29.01.2007 Committee considered case as per agenda and in light of production and consumption data certified by Central Excise Authority and in consultation with technical authority present in meeting, decided to enhance the quantity of Lithium Metal Catalyst Grade to the extent of 0.307 kg/kg of export product without any other change in the decision taken in 35/82 meeting held on 10.11.2009.
Case No.B431
M/S Jubilant Organosys Ltd. F.No.01/82/050/00651/AM07/DESIII RA F.No.05/24/040/00330/AM07 Adv.Lic.No.0510187592 dated 27.07.2006 Committee decided to defer case for 05.04.2011 for comments of Department of C&PC.
Case No.B432
M/S Akzo Noble (India) Ltd. F.No.01/82/050/00366/AM06/DESIII RA F.No.02/24/040/00079/AM06 Adv.Lic.No.0210080075 dated 25.07.2005 Committee considered case as per agenda and in line with SION A1421 and in consultation with technical authority present in meeting, decided to amend the description and quantity of import item No.1 to read as “Phthalic Anhydride – 0.66 kg/kg of export product” without any other change in the decision taken in 20/82 meeting held on 24.08.2005.
Case No.B433
M/S Aarti Industries Ltd. F.No.01/82/162/00332/AM11/DESIII RA F.No.03/94/040/00848/AM10 RA F.No.03/94/040/01063/AM10 Adv.Lic.No.0310553773 dated 05.01.2010 Adv.Lic.No.0310564399 dated 11.03.2010 Committee decided to defer case for 05.04.2011.
Case No.C41
M/S Laffans Petrochemicals Ltd F.No.01/82/162/01205/AM10/DESIII Committee decided to defer case for 19.07.2011 for comments of Department of C&PC. 1
Case No.:3/29/87ALC1/2009
Party Name:PARABOLIC DRUGS LTD., Meet No/Date:51/82ALC4/2010 Status:Case
22.03.2011 Deferred HQ File :01/87/050/00216/AM10/ RLA File :05/24/040/00302/AM10/ Lic.No/Date:0510250358 06.10.2009 Defer Date:19.04.2011 Decision :Committee decided to defer case for 19.04.2011 for comments of Department of Pharmaceuticals. 2
Case No.:27/34/82ALC4/2009
Party Name:VIVIMED LABS LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/00672/AM10/ RLA File :09/24/040/00310/AM10/ Lic.No/Date:0910039804 05.11.2009 Defer Date:05.04.2011 Decision :Committee decided to defer case for 05.04.2011 for comments of Department of C&PC. 3
Case No.:2/47/82ALC4/2010
Party Name:MEDREICH LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01592/AM11/ RLA File :07/21/040/00729/AM10/ Lic.No/Date:0710068320 17.11.2009 Defer Date:19.04.2011 Decision : Committee decided to defer case for 19.04.2011 for comments of Department of Pharmaceuticals. 4
Case No.:2/37/82ALC4/2009
Party Name:PADMINI AROMATICS PVT. LTD 22.03.2011 Status:Case Rejected HQ File :01/82/050/00745/AM10/ RLA File :07/24/040/00294/AM10/ Lic.No/Date:0710068389 19.11.2009 : Decision :Withdrawn as the case has already been rejected by NC in 30/82 meeting held on 26.10.2010. 5
Case No.:62/5/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 22.03.2011 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:19.04.2011 6
Case No.:14/41/82ALC4/2009
Party Name:RANBAXY LABORATORIES LTD 22.03.2011 Status:Case Deferred HQ File :01/82/050/00849/AM10/ RLA File :05/24/040/00414/AM10/ Lic.No/Date:0510255098 22.12.2009 Defer Date:19.04.2011 7
Case No.:8/44/82ALC4/2009
Party Name:EMAMI LIMITED, 22.03.2011 Status:Case Deferred HQ File :01/82/050/00893/AM10/ RLA File :02/24/040/00173/AM10/ Lic.No/Date:0210136503 14.01.2010 Defer Date:19.04.2011
Decision :Committee decided to defer case for 19.04.2011 for comments of DC(MSME). 8
Case No.:39/5/82ALC4/2010
Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 22.03.2011 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:19.04.2011 Decision :Committee decided to remind Department of Biotechnology for their comments through D.O. at the level of Chairman, NC3. Accordingly, case was deferred for 19.04.2011. 9
Case No.:33/48/82ALC4/2010
Party Name:KDAC CHEM PVT LTD 22.03.2011 Status:Case Approved HQ File :01/82/050/01676/AM11/ RLA File :34/24/040/00223/AM10/ Lic.No/Date:3410026557 09.03.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/97/2007 Ch.II dated 05.04.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Phenyl Ethyl Alcohol 1 Kg. 1. Styrene Monomer 1.00 kg 2. Hydrogen Peroxide 0.654 kg 3. Sodium Bicarbonate 0.250 kg 10
Case No.:30/14/82ALC4/2010
Party Name:PADMINI AROMATICS PVT. LTD 22.03.2011 Status:Case Deferred HQ File :01/82/050/00392/AM11/ RLA File :07/24/040/00037/AM11/ Lic.No/Date:0710071792 26.05.2010 Defer Date:19.04.2011 Decision :Committee decided to defer case for 19.04.2011 for comments of Department of C&PC. 11
Case No.:31/14/82ALC4/2010
Party Name:PADMINI AROMATICS PVT. LTD 22.03.2011 Status:Case Deferred HQ File :01/82/050/00393/AM11/ RLA File :07/24/040/00035/AM11/ Lic.No/Date:0710071909 31.05.2010 Defer Date:19.04.2011 Decision : Committee decided to defer case for 19.04.2011 for comments of Department of C&PC. 12
Case No.:2/43/82ALC4/2010
22.03.2011 Status:Case Deferred HQ File :01/82/050/01465/AM11/ RLA File :09/24/040/00090/AM11/ Lic.No/Date:0910042511 25.06.2010 Defer Date:19.04.2011
13
Case No.:18/47/82ALC4/2010
22.03.2011 Status:Case Deferred HQ File :01/82/050/01608/AM11/ RLA File :09/24/040/00505/AM10/ Lic.No/Date:0910042504 25.06.2010 Defer Date:19.04.2011 14
Case No.:78/15/82ALC4/2010
Party Name:ALEMBIC LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/00515/AM11/ RLA File :34/24/040/00070/AM11/ Lic.No/Date:3410027389 30.06.2010 Decision : Committee considered case as per agenda and in light of written comments of Department of Pharmaceuticals 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 Azirheomyxin Tablet 250 mg 1 No.. 1. Azithromycin Dihydrate 259.50 mg 2. Pregelatinized Starch (Starch 1500) 26.21 mg 3. Calcium Phosphate Dibasic Anhydrous 134.80 mg 4. Croscarmellose Sodium (AC Di Sol) 8.74 mg 5. Magnesium Stearate 3.628 mg 6. Sodium Lauryl Sulphate 0.900 mg 7. Aluminium Foil As per packing policy 8. PVC Foil As per packing policy 15
Case No.:63/39/82ALC4/2010
22.03.2011 Status:Case Deferred HQ File :01/82/050/01144/AM11/ RLA File :09/24/040/00116/AM11/ Lic.No/Date:0910042624 06.07.2010 Defer Date:19.04.2011 16
Case No.:68/39/82ALC4/2010
22.03.2011 Status:Case Deferred HQ File :01/82/050/01149/AM11/ RLA File :09/24/040/00054/AM11/ Lic.No/Date:0910042623 06.07.2010 Defer Date:19.04.2011 17
Case No.:71/39/82ALC4/2010
22.03.2011 Status:Case Deferred
HQ File :01/82/050/01152/AM11/ RLA File :09/24/040/00008/AM11/ Lic.No/Date:0910042622 06.07.2010 Defer Date:19.04.2011 18
Case No.:72/39/82ALC4/2010
22.03.2011 Status:Case Deferred HQ File :01/82/050/01153/AM11/ RLA File :09/24/040/00146/AM11/ Lic.No/Date:0910042671 12.07.2010 Defer Date:19.04.2011 19
Case No.:10/47/82ALC4/2010
Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHE 22.03.2011 Status:Case Approved HQ File :01/82/050/01600/AM11/ RLA File :05/23/040/00082/AM11/ Lic.No/Date:0510267990 13.07.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.14010/82/2010Ch.II dated 04.02.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Export Qty. Sl.No. Import items Qty. allowed 3Amino Methyl Pyridine 1 KG. 1. 3Cyanopyridine 1.13 kg 20
Case No.:22/19/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 22.03.2011 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:19.04.2011 21
Case No.:24/19/82ALC4/2010
Party Name:MSN LABORATORIES LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/00609/AM11/ RLA File :09/24/040/00143/AM11/ Lic.No/Date:0910042769 20.07.2010 : Decision : Committee considered case as per agenda and in line with SION A2637and on the basis of recommendations of representative from Department of Pharmaceuticals, the Committee decided to fix adhoc norms as under or as applied by the firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Finasteride 1 kg 1. NTButyl4aza5 AlphaAndrosta3one 17BetaCarboxamide 1.90 kg 2. Bis(trimethylsilyl) trifluoroacetamide (BSTFA) 1.47 kg
2,3dichloro5,6dicyano1,4 benzoquinone (DDQ) 0.86 kg 22
Case No.:102/22/82ALC4/2010
Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. 22.03.2011 Status:Case Approved HQ File :01/82/050/00755/AM11/ RLA File :31/24/040/00070/AM11/ Lic.No/Date:3110044017 20.07.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/6/2009 Ch.II dated 28.02.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Export Qty. Sl.No. Import items Qty. allowed Acetyl Anisole 1 KG. 1. Phenol 0.885 kg 2. Caustic Soda Lye 0.440 kg 3. Dimethyl Sulfate 0.680 kg 23
Case No.:25/19/82ALC4/2010
Party Name:NEULAND LABORATORIES LTD 22.03.2011 Status:Case Approved HQ File :01/82/050/00610/AM11/ RLA File :09/24/040/00128/AM11/ Lic.No/Date:0910042800 21.07.2010 Decision : Committee considered case as per agenda and in light of written comments of Department of Pharmaceuticals 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: Export product Export Qty. Sl.No. Import items Qty. allowed Levetiracetam 1kg. 1. (S)+2Amino Butyramide Hcl 0.95 kg 2. 4Chlorobutyryl Chloride 1.35 kg 3. Acetonitrile 2.71 kg 4. Potassium Carbonate 0.838 kg 5. Methylene Chloride 1.93 kg 6. DiIsopropyl Ether 1.30 kg 24
Case No.:14/23/82ALC4/2010
Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHE 22.03.2011 Status:Case Approved HQ File :01/82/050/00782/AM11/ RLA File :05/23/040/00212/AM10/ Lic.No/Date:0510268833 22.07.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 47/82 meeting held on 22.02.2011 in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
Export product Exp. Qty. Sl.No. Import items Qty. allowed Azacyclonol 1 Kg. 1. Tetrahydrofuran 2.81 kg 2. Gamma Picoline 0.74 kg 3. Magnesium Turning 0.30 kg 4. Toluene 0.405 kg 5. Monochloro Benzene 1.40 kg 6. Methanol 0.375 kg 25
Case No.:1/19/82ALC4/2010
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 22.03.2011 Status:Case Approved HQ File :01/82/050/00586/AM11/ RLA File :07/24/040/00135/AM11/ Lic.No/Date:0710073163 26.07.2010 : Decision : Committee considered case as per agenda and in line with SION A269 and in consultation with technical authority present in meeting, decided to ratify norms under Para 4.7 of Handbook of Procedures as per details below or as applied for by firm whichever is lower: Export Product Export Qty. S.No. Name of Item of import Quantity allowed Ceftriaxone for Injection USP 250 mg Vial Size 7.5 ml 1 Vial 1. Ceftriaxone Sodium USP Sterile 278.25 mg/vial RA concerned may take necessary action as per above decision of NC. 26
Case No.:32/19/82ALC4/2010
Party Name:SHILPA MEDICARE LTD., 22.03.2011 Status:Case Approved HQ File :01/82/050/00617/AM11/ RLA File :07/24/040/00137/AM11/ Lic.No/Date:0710073295 30.07.2010 : Decision : Committee considered case as per agenda and in light of earlier decision taken in 48/82 meeting held on 01.03.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. S.No. Import items Qty. allowed Gemcitabine Hcl 1 kg 1. 2Deoxy2,2DifluoroDErythro Pentafuranous1Ulose3,5Dibenzoate 5.14 kg 2. Tetra Hydro Furan 4.609 kg 3. Methylene Dichloride 6.285 kg 4. NAcetyl Cytosine 7.46 kg 5. Trimethyl Silyl Trifluoromethane Sulfonate 8.358 kg 6. Methanol 6.285 kg
27
Case No.:61/39/82ALC4/2010
Party Name:MEDCHL CHEMICALS AND PHARMACEUTICALS PVT LTD 22.03.2011 Status:Case Deferred HQ File :01/82/050/01142/AM11/ RLA File :09/24/040/00132/AM11/ Lic.No/Date:0910043003 06.08.2010 Defer Date:19.04.2011 28
Case No.:15/31/82ALC4/2010
Party Name:R L FINE CHEM 22.03.2011 Status:Case Deferred HQ File :01/82/050/00940/AM11/ RLA File :07/24/040/00156/AM11/ Lic.No/Date:0710073569 12.08.2010 Defer Date:19.04.2011 Decision :Committee decided to defer case for 19.04.2011 for comments of department of Pharmaceuticals. 29
Case No.:28/51/82ALC4/2010
Party Name:KUDOS CHEMIE LTD., 22.03.2011 Status:Case Approved HQ File :01/82/050/01745/AM11/ RLA File :22/21/040/00041/AM11/ Lic.No/Date:2210010306 18.08.2010 Decision : Committee considered case as per agenda for ratification of norms and in light of its earlier decision taken in its 45/82 meeting held on 02.02.2009 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 Caffeine (Synthetic Caffeine Anhydrous) 1kg. 1. Crude Theophylline 80% w/w (wet) Loss on Drying NLT 15% 1.15 kg 2. Caustic Soda (flakes of Lye) 0.24 kg 3. Dimethyl sulphate 0.68 kg 4. Activated Carbon 0.100 kg 30
Case No.:62/39/82ALC4/2010
Party Name:MEDCHL CHEMICALS AND PHARMACEUTICALS PVT LTD 22.03.2011 Status:Case Deferred HQ File :01/82/050/01143/AM11/ RLA File :09/24/040/00204/AM11/ Lic.No/Date:0910043136 19.08.2010 Defer Date:19.04.2011 31
Case No.:17/39/82ALC4/2010
22.03.2011 Status:Case Deferred HQ File :01/82/050/01098/AM11/ RLA File :09/24/040/00151/AM11/ Lic.No/Date:0910043227 24.08.2010 Defer Date:19.04.2011
32
Case No.:70/39/82ALC4/2010
Party Name:METROCHEM API PVT. LTD. 22.03.2011 Status:Case Approved HQ File :01/82/050/01151/AM11/ RLA File :09/24/040/00171/AM11/ Lic.No/Date:0910043238 24.08.2010 Decision : Committee considered case as per agenda and in light of written comments of Department of Pharmaceuticals and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl. No. Import items Qty. allowed 2Hydroxy Methyl3Methyl4 (2,2,2 Trifluoro Ethoxy) Pyridine Hydrochloride 1kg. 1. 2,3DimethylPyridine 0.79 kg 2. 2,2,2Trifluoro Ethanol 0.936 kg 33
Case No.:48/41/82ALC4/2010
Party Name:MEDITAB SPECIALITIES PVT. LTD. 22.03.2011 Status:Case Deferred HQ File :01/82/050/01396/AM11/ RLA File :03/95/040/00356/AM11/ Lic.No/Date:0310589522 25.08.2010 Defer Date:17.05.2011 Decision : Committee decided to defer case for 17.05.2011 for comments of Department of Pharmaceuticals. 34
Case No.:32/23/82ALC4/2010
Party Name:SUVEN LIFE SCIENCES LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/00800/AM11/ RLA File :09/24/040/00211/AM11/ Lic.No/Date:0910043338 31.08.2010 Defer Date:19.04.2011 Decision :Committee decided to defer case for 19.04.2011 for comments of Department of Pharmaceuticals. 35
Case No.:2/25/82ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 22.03.2011 Status:Case Approved HQ File :01/82/050/00816/AM11/ RLA File :08/24/040/00169/AM11/ Lic.No/Date:0810092030 09.09.2010 Decision : Committee considered case as per agenda and in light of written comments of Department of Pharmaceuticals and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl. No. Import items Qty. allowed Pravastatin 10 mg tablet 1No. 1. Pravastatin Sodium 10.2 mg 2. Microcrystalline Cellulose NF (Avicel PH 102) 32.25 mg 3. Lactose Anhydrous NF (Pharmatose DCL21) 51.24 mg 4. 60 CC White HDPE Bottle As per packing policy 5. Bottle 75 CC White HDPE Bottle As per packing policy
150 CC White HDPE Bottle As per packing policy 7. CRC White Cap 33 MM As per packing policy 8. CRC White Cap 38 MM As per packing policy Pravastatin 20 mg tablet 1 No. 1. Pravastatin Sodium 20.4 mg 2. Microcrystalline Cellulose NF (Avicel PH 102) 64.50 mg 3. Lactose Anhydrous NF (Pharmatose DCL21) 102.48 mg 4. 60 CC White HDPE Bottle As per packing policy 5. Bottle 75 CC White HDPE Bottle As per packing policy 6. 150 CC White HDPE Bottle As per packing policy 7. CRC White Cap 33 MM As per packing policy 8. CRC White Cap 38 MM As per packing policy Pravastatin 40 mg tablet 1 No. 1. Pravastatin Sodium 40.8 mg 2. Microcrystalline Cellulose NF (Avicel PH 102) 129.00 mg 3. Lactose Anhydrous NF (Pharmatose DCL21) 204.97 mg 4. 60 CC White HDPE Bottle As per packing policy 5. Bottle 75 CC White HDPE Bottle As per packing policy 6. 150 CC White HDPE Bottle As per packing policy 7. CRC White Cap 33 MM As per packing policy 8. CRC White Cap 38 MM As per packing policy Pravastatin 80 mg Tablet 1 No. 1. Pravastatin Sodium 81.6 mg 2. Microcrystalline Cellulose NF (Avicel PH 102) 258.0 mg 3. Lactose Anhydrous NF (Pharmatose DCL21) 409.94 mg 4. 60 CC White HDPE Bottle As per packing policy 5. Bottle 75 CC White HDPE Bottle As per packing policy 6. 150 CC White HDPE Bottle As per packing policy
CRC White Cap 33 MM As per packing policy 8. CRC White Cap 38 MM As per packing policy 36
Case No.:7/27/82ALC4/2010
Party Name:VIVIMED LABS LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/00874/AM11/ RLA File :09/24/040/00129/AM11/ Lic.No/Date:0910043626 24.09.2010 Decision : Committee considered case as per agenda and in light of written comments of Department of Pharmaceuticals 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 Triclosan/2,4,4Trichloro2 Hydroxy Diphenyl Ether/VIV2 1kg. 1. 2,4 dichloro Phenol 1.35 kg 2. Perchloro Ethylene 4.57 kg 3. Sodium Nitrite 0.59 kg 4. NHexane 3.00 kg 37
Case No.:9/39/82ALC4/2010
Party Name:CIPLA LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01090/AM11/ RLA File :03/94/040/00560/AM11/ Lic.No/Date:0310594225 28.09.2010 Defer Date:12.04.2011 Decision :Committee decided to defer case for 12.04.2011 for NOC from Ministry of E&F. 38
Case No.:23/28/82ALC4/2010
Party Name:ANDHRA ORGANICS LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/00905/AM11/ RLA File :09/24/040/00233/AM11/ Lic.No/Date:0910043787 01.10.2010 Defer Date:19.04.2011 39
Case No.:74/39/82ALC4/2010
Party Name:CIPLA LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01155/AM11/ RLA File :03/94/040/00601/AM11/ Lic.No/Date:0310594787 01.10.2010 Defer Date:05.04.2011 Decision : Committee decided to defer case for 05.04.2011 for NOC from Ministry of E&F.. 40
Case No.:16/39/82ALC4/2010
Party Name:CTX LIFESCIENCES PVT Status:Case Deferred
LTD, 22.03.2011 HQ File :01/82/050/01097/AM11/ RLA File :03/94/040/00500/AM11/ Lic.No/Date:0310595131 04.10.2010 Defer Date:17.05.2011 41
Case No.:9/29/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/00919/AM11/ RLA File :09/24/040/00255/AM11/ Lic.No/Date:0910043812 06.10.2010 Defer Date:17.05.2011 Decision :Committee decided to defer case for 17.05.2011 for comments of Department of Pharmaceuticals. 42
Case No.:28/47/82ALC4/2010
Party Name:CHIRAL BIOSCIENCES LTD., 22.03.2011 Status:Case Deferred HQ File :01/82/050/01618/AM11/ RLA File :09/24/040/00162/AM11/ Lic.No/Date:0910043817 06.10.2010 Defer Date:17.05.2011 43
Case No.:40/39/82ALC4/2010
Party Name:ACTAVIS PHARMA MANUFACTURING PVT.LTD 22.03.2011 Status:Case Deferred HQ File :01/82/050/01121/AM11/ RLA File :04/24/040/00167/AM11/ Lic.No/Date:0410117838 07.10.2010 Defer Date:17.05.2011 44
Case No.:83/39/82ALC4/2010
Party Name:ALEMBIC LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/01164/AM11/ RLA File :34/24/040/00161/AM11/ Lic.No/Date:3410028223 07.10.2010 Decision : Committee considered case as per agenda and in light of written comments of Department of Pharmaceuticals 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 Azirheomyxin Tablet 250 mg 1 No.. 1. Azithromycin Dihydrate 259.50 mg 2. Pregelatinized Starch (Starch 1500) 26.21 mg 3. Calcium Phosphate Dibasic Anhydrous 134.80 mg 4. Croscarmellose Sodium (AC Di Sol) 8.74 mg 5. Magnesium Stearate 3.628 mg 6. Sodium Lauryl Sulphate 0.900 mg Azithromycin Tablet 500 mg 1 No. 1. Azithromycin Dihydrate 519.02 mg 2. Pregelatinized Starch (Starch 1500) 52.42 mg 3. Calcium Phosphate Dibasic Anhydrous 269.58 mg 4. Croscarmellose Sodium (AC Di Sol) 17.48 mg
Magnesium Stearate 7.348 mg 6. Sodium Lauryl Sulphate 1.80 mg 45
Case No.:85/39/82ALC4/2010
Party Name:TRANSPEK INDUSTRY LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01166/AM11/ RLA File :34/24/040/00179/AM11/ Lic.No/Date:3410028299 13.10.2010 Defer Date:19.04.2011 Decision :Committee decided to forward a copy of application to Department of C&PC for their comments. Accordingly, case was deferred for 19.04.2011. 46
Case No.:8/31/82ALC4/2010
Party Name:GLAND PHARMA LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/00933/AM11/ RLA File :09/24/040/00290/AM11/ Lic.No/Date:0910043914 14.10.2010 Defer Date:17.05.2011 47
Case No.:33/39/82ALC4/2010
Party Name:STAR ORECHEM INTERNATIONAL PVT. LTD. 22.03.2011 Status:Case Approved HQ File :01/82/050/01114/AM11/ RLA File :50/24/040/00013/AM11/ Lic.No/Date:5010000420 14.10.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 41/11 meeting held on 11.01.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl. No. Import items Qty. allowed Metal ExtractantT 30 1kg. 1. Nonyl Phenol 0.628 kg 2. Paraformaldehyde 96% 0.260 kg 3. Hydroxylamine Sulphate Monohydrate 0.197 kg 4. Hydrocarbon Solvent 0.165 kg 5. Texamol Isobutyrate (TXIB) 0.300 kg 6. Toluene 0.296 kg 48
Case No.:53/39/82ALC4/2010
Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 22.03.2011 Status:Case Approved HQ File :01/82/050/01134/AM11/ RLA File :03/95/040/00540/AM11/ Lic.No/Date:0310597325 18.10.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/43/2007 Ch.II dated 10.05.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or
Export product Exp. Qty. Sl.No. Import items Qty. allowed 2[(Chloro Methyl) Mercapto] Benzo Thiazole (CMBT) 1 Kg. 1. 2Mercapto Benzo Thiazole 0.910 kg 2. Methylene Chloride 0.272 kg 3. Di Bromo Methane 0.557 kg 49
Case No.:38/40/82ALC4/2010
Party Name:LUPIN LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01237/AM11/ RLA File :03/95/040/00564/AM11/ Lic.No/Date:0310597425 18.10.2010 Defer Date:19.04.2011 Decision :Committee decided to defer case for 19.04.2011 for comments of Department of Pharmaceuticals. 50
Case No.:124/40/82ALC4/2010
Party Name:SURYA PHARMACEUTICAL LTD Meet No/Date:51/82ALC4/2010 22.03.2011 Status:Case Deferred HQ File :01/82/050/01323/AM11/ RLA File :22/24/040/00049/AM11/ Lic.No/Date:2210010535 18.10.2010 Defer Date:19.04.2011 51
Case No.:19/40/82ALC4/2010
Party Name:BOSTIK INDIA PRIVATE LIMITED Meet No/Date:51/82ALC4/2010 22.03.2011 Status:Case Deferred HQ File :01/82/050/01218/AM11/ RLA File :07/24/040/00427/AM10/ Lic.No/Date:0710074879 19.10.2010 Defer Date:19.04.2011 Decision :Committee decided to forward a copy of application to Department of C&PC, Petrochemicals Division for their comments. Accordingly, case was deferred for 19.04.2011. 52
Case No.:48/31/82ALC4/2010
Party Name:GLAND PHARMA LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/00973/AM11/ RLA File :09/24/040/00297/AM11/ Lic.No/Date:0910043978 20.10.2010 Defer Date:17.05.2011 53
Case No.:21/39/82ALC4/2010
Party Name:ALEMBIC LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/01102/AM11/ RLA File :34/24/040/00178/AM11/ Lic.No/Date:3410028407 25.10.2010 Decision : Committee considered case as per agenda and in light of written comments of Department of Pharmaceuticals 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 Azirheomyxin Tablet 1 No.. 1. Azithromycin Dihydrate 259.50 mg
250 mg 2. Pregelatinized Starch (Starch 1500) 26.21 mg 3. Calcium Phosphate Dibasic Anhydrous 134.80 mg 4. Croscarmellose Sodium (AC Di Sol) 8.74 mg 5. Magnesium Stearate 3.628 mg 6. Sodium Lauryl Sulphate 0.900 mg Azithromycin Tablet 500 mg 1 No. 1. Azithromycin Dihydrate 519.02 mg 2. Pregelatinized Starch (Starch 1500) 52.42 mg 3. Calcium Phosphate Dibasic Anhydrous 269.58 mg 4. Croscarmellose Sodium (AC Di Sol) 17.48 mg 5. Magnesium Stearate 7.348 mg 6. Sodium Lauryl Sulphate 1.80 mg 54
Case No.:56/40/82ALC4/2010
22.03.2011 Status:Case Deferred HQ File :01/82/050/01255/AM11/ RLA File :09/24/040/00236/AM11/ Lic.No/Date:0910044022 26.10.2010 Defer Date:17.05.2011 55
Case No.:2/32/82ALC4/2010
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 22.03.2011 Status:Case Approved HQ File :01/82/050/00984/AM11/ RLA File :07/24/040/00286/AM11/ Lic.No/Date:0710075068 27.10.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 47/11 meeting held on 22.02.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Export Qty. Sl.No. Import items Qty. allowed Kanamycin Acid Sulphate for Inj. BP 1 gm Vial Size:10 ml 1 Vial 1. Kanamycin Acid Sulphate Sterile BP 1.466 gram 56
Case No.:140/40/82ALC4/2010
Party Name:ARCH PHARMALABS LTD 22.03.2011 Status:Case Approved HQ File :01/82/050/01339/AM11/ RLA File :05/23/040/00179/AM11/ Lic.No/Date:0510275915 28.10.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments of Department of Pharmaceuticals 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 Perindopril DC Granules 4.92% Drug Formulation 6958.000 kg 1. (2s,3as,7as) Octahydro indole2 Carboxylic Acid NLT 98% 350.000 kg
dispersible/Soluble Powder and Granules 2. LNorvaline NLT 98% 560.000 kg 3. Acetonitrile NLT 98% 7350.000 kg 4. Hydroxy Benzotrazole NLT 98% 350.000 kg 5. N,NDiclohexylcarbodaminde (DCC) NLT 98% 350.000 kg 57
Case No.:7/33/82ALC4/2010
Party Name:BLISS GVS PHARMA LTD. 22.03.2011 Status:Case Approved HQ File :01/82/050/01001/AM11/ RLA File :03/94/040/00708/AM11/ Lic.No/Date:0310600070 03.11.2010 Decision : Committee considered case as per agenda and in light of written comments of Department of Pharmaceuticals and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed FunbactA Cream 30 mg Tube 1. Clotrimazole USP 0.306 gm/30 gm Tube 2. Neomycin Sulphate USP 0.153 gm/30 gm Tube RA concerned may take further necessary action as per above decision of Norms. 58
Case No.:15/40/82ALC4/2010
Party Name:CIPLA LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/01214/AM11/ RLA File :03/94/040/00724/AM11/ Lic.No/Date:0310600251 04.11.2010 Decision : Committee considered case as per agenda and in light of written comments of Department of Pharmaceuticals 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 Piperacillin Sodium and Tazobactam Sodium Injection 4.5 gm/Tazact Inj 4.5 gm 400000 Vials 1. Tazobactam Sodium + Piperacillin Sodium (Sterile) 2071.548 kg 59
Case No.:3/35/82ALC4/2010
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 22.03.2011 Status:Case Deferred HQ File :01/82/050/01019/AM11/ RLA File :04/24/040/00215/AM11/ Lic.No/Date:0410118914 16.11.2010 Defer Date:17.05.2011 Decision :Committee decided to call for a copy of relevant Drug Manufacturing Licence from the firm. Accordingly, case was deferred for 17.05.2011.
py g g g y 60
Case No.:26/51/82ALC4/2010
Party Name:KUDOS CHEMIE LTD., 22.03.2011 Status:Case Approved HQ File :01/82/050/01743/AM11/ RLA File :22/21/040/00077/AM11/ Lic.No/Date:2210010633 16.11.2010 : Decision : Committee considered case as per agenda for ratification of norms and in light of its earlier decision taken in its 45/82 meeting held on 02.02.2009 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 Caffeine (Synthetic Caffeine Anhydrous) 1kg. 1. Crude Theophylline 80% w/w (wet) Loss on Drying NLT 15% 1.15 kg 2. Caustic Soda (flakes of Lye) 0.24 kg 3. Dimethyl sulphate 0.68 kg 4. Activated Carbon 0.100 kg 61
Case No.:7/35/82ALC4/2010
Party Name:RA CHEM PHARMA LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01023/AM11/ RLA File :09/24/040/00359/AM11/ Lic.No/Date:0910044295 18.11.2010 Defer Date:17.05.2011 62
Case No.:12/35/82ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 22.03.2011 Status:Case Deferred HQ File :01/82/050/01028/AM11/ RLA File :05/24/040/00286/AM11/ Lic.No/Date:0510277419 22.11.2010 Defer Date:17.05.2011 Decision :Committee decided to defer case for 17.05.2011 for comments of Department of Pharmaceuticals. 63
Case No.:13/35/82ALC4/2010
Party Name:SAINOR LABORATORIES PVT LTD 22.03.2011 Status:Case Approved HQ File :01/82/050/01029/AM11/ RLA File :09/24/040/00323/AM11/ Lic.No/Date:0910044371 22.11.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/112/2010 Ch.II dated 28.02.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or Export Product Export Qty. Sl.No. Import items Qty. allowed nButyl Magnesium Chloride 24% 1 KG. 1. nButyl Chloride 0.200 kg 2. Tetrahydrofuran 1.00 kg
64
Case No.:17/35/82ALC4/2010
Party Name:ALEMBIC LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01033/AM11/ RLA File :34/24/040/00216/AM11/ Lic.No/Date:3410028617 22.11.2010 Defer Date:17.05.2011 65
Case No.:19/35/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01035/AM11/ RLA File :09/24/040/00319/AM11/ Lic.No/Date:0910044382 22.11.2010 Defer Date:19.04.2011 66
Case No.:20/35/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01036/AM11/ RLA File :09/24/040/00333/AM11/ Lic.No/Date:0910044383 22.11.2010 Defer Date:19.04.2011 67
Case No.:107/39/82ALC4/2010
Party Name:CIPLA LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/01188/AM11/ RLA File :03/94/040/00757/AM11/ Lic.No/Date:0310602264 22.11.2010 Decision :Withdrawn as the case has already been approved by NC in its 47/82 meeting held on 22.02.2011. 68
Case No.:22/35/82ALC4/2010
Party Name:GRANULES INDIA LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/01038/AM11/ RLA File :09/24/040/00338/AM11/ Lic.No/Date:0910044392 23.11.2010 Decision : Withdrawn as the case has already been approved by NC in its 47/82 meeting held on 22.02.2011. 69
Case No.:106/39/82ALC4/2010
Party Name:CIPLA LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/01187/AM11/ RLA File :03/94/040/00786/AM11/ Lic.No/Date:0310603094 25.11.2010 Decision : Withdrawn as the case has already been approved by NC in its 47/82 meeting held on 22.02.2011. 70
Case No.:26/40/82ALC4/2010
Party Name:HETERO LABS LIMITED Status:Case
22.03.2011 Approved HQ File :01/82/050/01225/AM11/ RLA File :09/24/040/00357/AM11/ Lic.No/Date:0910044448 25.11.2010 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 details below or as applied by firm whichever is lower: Export Product Export Qty. Sl.No. Import items Qty. allowed Losartan Potassium 1 KG. 1. 2Butyl4Chloro5Formyl Imidazole 0.62 kg 2. 4Bromomethyl2Cyano Biphenyl 1.117 kg 3. Sodium Borohydride 0.048 kg 4. Toluene 3.42 kg 5. Methanol 2.00 kg 6. NMethyl Pyrrolidone 1.20 kg 71
Case No.:6/43/82ALC4/2010
Party Name:ASTRIX LABORATORIES LTD., 22.03.2011 Status:Case Deferred HQ File :01/82/050/01469/AM11/ RLA File :09/24/040/00292/AM11/ Lic.No/Date:0910044462 25.11.2010 Defer Date:17.05.2011 72
Case No.:19/47/82ALC4/2010
Party Name:ASTRIX LABORATORIES LTD., 22.03.2011 Status:Case Deferred HQ File :01/82/050/01609/AM11/ RLA File :09/24/040/00291/AM11/ Lic.No/Date:0910044461 25.11.2010 Defer Date:17.05.2011 73
Case No.:91/39/82ALC4/2010
Party Name:FRESENIUS KABI ONCOLOGY LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01172/AM11/ RLA File :05/23/040/00176/AM11/ Lic.No/Date:0510278093 29.11.2010 Defer Date:19.04.2011 74
Case No.:93/39/82ALC4/2010
Party Name:FRESENIUS KABI ONCOLOGY LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01174/AM11/ RLA File :05/23/040/00175/AM11/ Lic.No/Date:0510278092 29.11.2010 Defer Date:19.04.2011
75
Case No.:97/39/82ALC4/2010
Party Name:FRESENIUS KABI ONCOLOGY LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01178/AM11/ RLA File :05/23/040/00010/AM11/ Lic.No/Date:0510278091 29.11.2010 Defer Date:19.04.2011 76
Case No.:102/39/82ALC4/2010
Party Name:LUPIN LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01183/AM11/ RLA File :03/95/040/00687/AM11/ Lic.No/Date:0310603435 29.11.2010 Defer Date:17.05.2011 Decision :Committee considered case as per agenda and decided to ask the firm to indicate whether the export product Ramipril is being manufactured through Noninfringing process and if there is noninfringing process, the firm may furnish production and consumption data certified by Central Excise Authority. Accordingly, case was deferred for 17.05.2011. 77
Case No.:47/40/82ALC4/2010
Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/01246/AM11/ RLA File :03/94/040/00728/AM11/ Lic.No/Date:0310603965 01.12.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/83/2006 Ch.II dated 22.07.2008 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Para Teritiary Butyl Cyclohexyl Acetate 1 Kg. 1. Para Tertiary Butyl Phenol 0.820 kg 2. 5% Ruthenium on Carbon Catalyst 0.00003 kg 3. Acetic Acid 0.300 kg 4. Methanol 0.330 kg 78
Case No.:25/47/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01615/AM11/ RLA File :09/24/040/00346/AM11/ Lic.No/Date:0910044599 07.12.2010 Defer Date:17.05.2011 Decision :Committee decided to defer case for 17.05.2011 for comments of Department of Pharmaceuticals. 79
Case No.:17/51/82ALC4/2010
Party Name:SUVEN LIFE SCIENCES LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/01734/AM11/ RLA File :09/24/040/00368/AM11/ Lic.No/Date:0910044622 09.12.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/332/2009PI(Norms) dated 09.01.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of
HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Methyl 22 Chloromethylphenyl3 Methoxy2Acrylate 1 Kg. 1. 3Isochromanone 0.957 kg 2. OXylene 1.04 kg 3. Sodium Methoxide Powder 0.416 kg 4. NMethylformaniolde 0.083 kg 5. Methanol 2.31 kg 80
Case No.:18/51/82ALC4/2010
Party Name:SUVEN LIFE SCIENCES LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/01735/AM11/ RLA File :09/24/040/00393/AM11/ Lic.No/Date:0910044624 09.12.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/332/2009PI(Norms) dated 09.01.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Methyl 22 Chloromethylphenyl3 Methoxy2Acrylate 1 Kg. 1. 3Isochromanone 0.957 kg 2. OXylene 1.04 kg 3. Sodium Methoxide Powder 0.416 kg 4. NMethylformaniolde 0.083 kg 5. Methanol 2.31 kg 81
Case No.:19/51/82ALC4/2010
Party Name:SUVEN LIFE SCIENCES LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01736/AM11/ RLA File :09/24/040/00372/AM11/ Lic.No/Date:0910044623 09.12.2010 Defer Date:17.05.2011 Decision :Committee decided to defer case for 17.05.2011 for comments of Department of Pharmaceuticals. 82
Case No.:78/39/82ALC4/2010
Party Name:METROPOLITAN EXIMCHEM LTD. 22.03.2011 Status:Case Deferred HQ File :01/82/050/01159/AM11/ RLA File :03/95/040/00657/AM11/ Lic.No/Date:0310605745 10.12.2010 Defer Date:19.04.2011 Decision :Committee decided to forward a copy of application to Department of C&PC for their comments. Accordingly, case was deferred for 19.04.2011. 83
Case No.:77/41/82ALC4/2010
Party Name:BLISS GVS PHARMA LTD. 22.03.2011 Status:Case Approved
HQ File :01/82/050/01425/AM11/ RLA File :03/94/040/00836/AM11/ Lic.No/Date:0310605981 13.12.2010 Decision : Committee considered case as per agenda and in light of written comments of Department of Pharmaceuticals and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed FunbactA Cream 30 mg Tube 1. Clotrimazole USP 0.306 gm/30 gm Tube 2. Neomycin Sulphate USP 0.153 gm/30 gm Tube RA concerned may take further necessary action as per above decision of Norms. 84
Case No.:65/40/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 22.03.2011 Status:Case Deffered HQ File :01/82/050/01264/AM11/ RLA File :09/24/040/00417/AM11/ Lic.No/Date:0910044738 16.12.2010 Defer Date:17.05.2011 Decision :Committee decided to defer case for 17.05.2011 for comments of Department of Pharmaceuticals. 85
Case No.:20/47/82ALC4/2010
Party Name:COVALENT LABORATORIES PRIVATE LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01610/AM11/ RLA File :09/24/040/00230/AM11/ Lic.No/Date:0910044835 21.12.2010 Defer Date:19.04.2011 86
Case No.:28/43/82ALC4/2010
Party Name:GLENMARK GENERICS LIMITED Meet No/Date:51/82ALC4/2010 22.03.2011 Status:Case Deferred HQ File :01/82/050/01491/AM11/ RLA File :03/94/040/00850/AM11/ Lic.No/Date:0310607789 24.12.2010 Defer Date:19.04.2011 Decision :Committee decided to defer case for 19.04.2011 for comments of Department of Pharmaceuticals. 87
Case No.:14/41/82ALC4/2010
Party Name:ANDHRA ORGANICS LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01362/AM11/ RLA File :09/24/040/00405/AM11/ Lic.No/Date:0910044913 27.12.2010 Defer Date:19.04.2011 88
Case No.:15/41/82ALC4/2010
Party Name:ANDHRA ORGANICS LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01363/AM11/ RLA File :09/24/040/00379/AM11/ Lic.No/Date:0910044914 Defer
27.12.2010 Date:19.04.2011 89
Case No.:16/44/82ALC4/2010
Party Name:GLENMARK GENERICS LIMITED Meet No/Date:51/82ALC4/2010 22.03.2011 Status:Case Deferred HQ File :01/82/050/01515/AM11/ RLA File :03/94/040/00851/AM11/ Lic.No/Date:0310608261 28.12.2010 Defer Date:19.04.2011 Decision :Committee decided to defer case for 19.04.2011 for comments of Department of Pharmaceuticals. 90
Case No.:33/41/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01381/AM11/ RLA File :09/24/040/00447/AM11/ Lic.No/Date:0910044965 31.12.2010 Defer Date:17.05.2011 91
Case No.:95/41/82ALC4/2010
Party Name:RA CHEM PHARMA LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01443/AM11/ RLA File :09/24/040/00443/AM11/ Lic.No/Date:0910045024 03.01.2011 Defer Date:19.04.2011 Decision :Committee decided to call for a copy of valid Drug Manufacturing Licence issued in favour of RA Chem Pharma Ltd. According, case was deferred for 19.04.2011. 92
Case No.:10/51/82ALC4/2010
Party Name:CIPLA LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/01727/AM11/ RLA File :03/94/040/00879/AM11/ Lic.No/Date:0310609046 03.01.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/15/2010PI (Norms) dated 08.06.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Amoxicillin & Clavulanate Potassium for Suspension USP 75 ml pack 1. Amoxycillin Trihydrate 4.200 gm 2. Clavulanate Potassium Syloid 2.3444 gm 3. Silicon Dioxide (Syloid AL1FP)NF 1.500 gm 4. 115 CC N/M Pen RD Nat 28.0 GR SN (For MGP) As per packing policy 5. 185 CC N/M Pen RND Material Natural 36GR SN (For MGP) 6. 225 CC N/M Pen RD NAT.43.00 GRN (For MGP) 7. Cap 28/400 WHT CRC W/FS M1 Amoxicillin & 100 ml pack 1. Amoxycillin Trihydrate 5.649 gm
Clavulanate Potassium for Suspension USP 2. Clavulanate Potassium Syloid 3.126 gm 3. Silicon Dioxide (Syloid AL1FP)NF 2.00 gm 4. 115 CC N/M Pen RD Nat 28.0 GR SN (For MGP) 5. 185 CC N/M Pen RND Material Natural 36GR SN (For MGP) 6. 225 CC N/M Pen RD NAT.43.00 GRN (For MGP) 7. Cap 28/400 WHT CRC W/FS M1 Amoxicillin & Clavulanate Potassium for Suspension USP 150 ml pack 1. Amoxycillin Trihydrate 8.274 gm 2. Clavulanate Potassium Syloid 4.6888 gm 3. Silicon Dioxide (Syloid AL1FP)NF 3.00 gm 4. 115 CC N/M Pen RD Nat 28.0 GR SN (For MGP) 5. 185 CC N/M Pen RND Material Natural 36GR SN (For MGP) 6. 225 CC N/M Pen RD NAT.43.00 GRN (For MGP) 7. Cap 28/400 WHT CRC W/FS M1 93
Case No.:15/44/82ALC4/2010
Party Name:BLISS GVS PHARMA LTD. 22.03.2011 Status:Case Approved HQ File :01/82/050/01514/AM11/ RLA File :03/94/040/00887/AM11/ Lic.No/Date:0310609857 06.01.2011 Decision : Committee considered case as per agenda and in light of written comments of Department of Pharmaceuticals and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed FunbactA Cream 30 mg Tube 1. Clotrimazole USP 0.306 gm/30 gm Tube 2. Neomycin Sulphate USP 0.153 gm/30 gm Tube RA concerned may take further necessary action as per above decision of Norms. 94
Case No.:48/47/82ALC4/2010
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 22.03.2011 Status:Case Approved HQ File :01/82/050/01638/AM11/ RLA File :03/94/040/00854/AM11/ Lic.No/Date:0310609825 06.01.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/11/2008 Ch.II dated 11.05.2010 and in consultation with technical authorities present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or
Export product Exp. Qty. Sl.No. Import items Qty. allowed 2,5Dimethyl Phenyl Acetyl chloride 1 Kg. 1. Para Xylene 1.485 kg 2. Paraformaldehyde 1.032 kg 3. Sodium Cyanide 0.570 kg 4. Caustic Soda Flakes 0.500 kg 5. Thionyl Chloride 0.980 kg 95
Case No.:14/51/82ALC4/2010
Party Name:TITAN LABORATORIES PVT. LTD. 22.03.2011 Status:Case Deferred HQ File :01/82/050/01731/AM11/ RLA File :03/95/040/00694/AM11/ Lic.No/Date:0310609837 06.01.2011 Defer Date:17.05.2011 96
Case No.:15/47/82ALC4/2010
Party Name:TRIGON CHEMICALS PVT. LTD. 22.03.2011 Status:Case Approved HQ File :01/82/050/01605/AM11/ RLA File :31/24/040/00177/AM11/ Lic.No/Date:3110046349 10.01.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/113/2010 Ch.II dated 10.03.2011 and in consultation with technical authorities present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or Export product Exp. Qty. Sl.No. Import items Qty. allowed Lithium Benzoate 1 Kg. 1. Benzoic Acid 1.00 kg Note:As per the chemical dictionary, Lithium Benzoate is derived by reaction of Benzoic Acid with Lithium Carbonate. Also as per chemical dictionary, Lithium Hydroxide is derived by causticising Lithium Carbonate. Therefore, Lithium Carbonate has not been allowed. 97
Case No.:14/43/82ALC4/2010
Party Name:VITAL LABORATORIES PVT. LTD. 22.03.2011 Status:Case Deferred HQ File :01/82/050/01477/AM11/ RLA File :03/95/040/00790/AM11/ Lic.No/Date:0310610687 12.01.2011 Defer Date:17.05.2011 Decision :Committee decided to defer case for 17.05.2011for comments of Department of Pharmaceuticals. 98
Case No.:15/43/82ALC4/2010
Party Name:PORUS LABORATORIES PVT LTD. 22.03.2011 Status:Case Deferred HQ File :01/82/050/01478/AM11/ RLA File :09/24/040/00457/AM11/ Lic.No/Date:0910045121 12.01.2011 Defer Date:19.04.2011
Decision : Committee decided to defer case for 19.04.2011 for comments of Department of C&PC. 99
Case No.:18/43/82ALC4/2010
Party Name:CIPLA LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/01481/AM11/ RLA File :03/94/040/00904/AM11/ Lic.No/Date:0310610747 12.01.2011 Decision :Committee considered case as per agenda and in light of written comments of Department of Pharmaceuticals and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as applied by the firm. RA concerned may take further necessary action as per above decision of NC. 100
Case No.:22/43/82ALC4/2010
Party Name:YASHO INDUSTRIES PVT.LTD. 22.03.2011 Status:Case Approved HQ File :01/82/050/01485/AM11/ RLA File :03/95/040/00841/AM11/ Lic.No/Date:0310611297 17.01.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/46/2009 Ch.II dated 21.03.2011 and in consultation with technical authorities present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or Export product Exp. Qty. Sl.No. Import items Qty. allowed Tetrabenzyl Thiuram Disulfide 1 Kg. 1. Dibenzylamine 0.743 kg 101
Case No.:24/43/82ALC4/2010
Party Name:NEULAND LABORATORIES LTD 22.03.2011 Status:Case Approved HQ File :01/82/050/01487/AM11/ RLA File :09/24/040/00456/AM11/ Lic.No/Date:0910045161 17.01.2011 Decision : Committee considered case as per agenda and in light of written comments of Department of Pharmaceuticals 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 Salmeterol Xinafoate 1kg. 1. 1Hydroxy 2Napthoic Acid 1.00 kg 2. 20% Palladium on Carbon 0.200 kg 3. N,NDiisopropyl Ethylamine 3.33 kg 4. NHeptane 10.00 kg 5. Sodium Borohydride 5.47 kg 6. Dimethyl Formamide 1.90 kg 102 Case No.:25/43/82ALC4/2010 Party Name:NEULAND LABORATORIES LTD Status:Case
22.03.2011 Approved HQ File :01/82/050/01488/AM11/ RLA File :09/24/040/00458/AM11/ Lic.No/Date:0910045162 17.01.2011 Decision : Committee considered case as per agenda and in light of written comments of Department of Pharmaceuticals dated 04.02.2003 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Isopropyl(Z)7{(1R,2R,3R,5S)3,5 Dihydroxy2{(3R)3Hydroxy5 Phenylpentyllcyclopentyl}5 Heptenoate {Latonoprost} 1 Kg. 1. Tris Tes 3.69 kg 2 Pyridinium Tosylate 0.100 kg 3. Acetone 18.45 ltrs. 4. Ethyl Acetate 80.74 ltrs. 5. Hexane Hipersoly 15.35 ltrs. 6. Silica Gel 60 4063 mm 13.17 kg 7. NHeptane 944.64 ltrs 8. Acetonitrile Hipersoly 36.90 ltrs 9. HPLC Grade Isoprppyl Alcohol 55.35 ltrs. 103
Case No.:23/43/82ALC4/2010
Party Name:SHASUN PHARMACEUTICALS LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/01486/AM11/ RLA File :04/24/040/00281/AM11/ Lic.No/Date:0410120793 18.01.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 20/04 meeting held on 21.08.2003 and in consultation with technical authority from Department of Pharmaceuticals, 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: Export product Exp. Qty. Sl.No. Import items Qty. allowed Methohexital USP 1 kg 1. 3Butyn2OL (50%) 9.50 kg 2. Ethyl Vinyl Ether 5.48 kg 3. Ethyl Cyano Acetate 3.62 kg 4. Tetra Hydro Furan 5.42 kg 5. Sodium Metal 0.45 kg 6. Methylene Chloride 3.68 kg 7. NMethyl Urea 1.35 kg 8. Isopropyl Alcohol 2.29 kg 9. Pyridine 0.16 kg 10. Allyl Chloride 1.08 kg 11. Dichloro Acetic Acid 0.50 kg 104 Case No.:27/47/82ALC4/2010 Party Name:R.R.J. DYES & INTERMEDIATES Meet No/Date:51/82ALC4/2010 Status:Case
LTD. 22.03.2011 Deferred HQ File :01/82/050/01617/AM11/ RLA File :08/24/040/00307/AM11/ Lic.No/Date:0810095587 19.01.2011 Defer Date:19.04.2011 105
Case No.:15/51/82ALC4/2010
Party Name:TITAN LABORATORIES PVT. LTD. 22.03.2011 Status:Case Approved HQ File :01/82/050/01732/AM11/ RLA File :03/95/040/00845/AM11/ Lic.No/Date:0310611821 19.01.2011 Decision : Committee considered case as per agenda and in consultation with technical authorities present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Flurbiprofen SR Pellets 88.9% 1 Kg. 1. Flurbiprofen 0.8979 kg 106
Case No.:46/47/82ALC4/2010
Party Name:INDOCO REMEDIES LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01636/AM11/ RLA File :03/94/040/00948/AM11/ Lic.No/Date:0310612215 21.01.2011 Defer Date:19.04.2011 107
Case No.:11/47/82ALC4/2010
Party Name:VIVEK PHARMACHEM (INDIA) LTD., 22.03.2011 Status:Case Deferred HQ File :01/82/050/01601/AM11/ RLA File :13/24/040/00029/AM11/ Lic.No/Date:1310034441 24.01.2011 Defer Date:17.05.2011 108
Case No.:16/51/82ALC4/2010
Party Name:TITAN LABORATORIES PVT. LTD. 22.03.2011 Status:Case Approved HQ File :01/82/050/01733/AM11/ RLA File :03/95/040/00863/AM11/ Lic.No/Date:0310612374 24.01.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 2/82 meeting held on 13.04.2010 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: Export product Export Qty. Sl.No. Import items Qty. allowed Orlistat Pellets 50% 1 kg. 1. Orlistat 0.505 kg
109
Case No.:22/51/82ALC4/2010
Party Name:BALAJI AMINES LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01739/AM11/ RLA File :31/24/040/00062/AM11/ Lic.No/Date:3110046571 24.01.2011 Defer Date:17.05.2011 Decision : Committee decided to defer case for 17.05.2011 for comments of Department of C&PC. 110
Case No.:23/51/82ALC4/2010
Party Name:BALAJI AMINES LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/01740/AM11/ RLA File :31/24/040/00185/AM11/ Lic.No/Date:3110046568 24.01.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/113/2008 Ch.III dated 29.03.2009 and in consultation with technical authorities present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Gamma Butyrolactone 1 Kg. 1. Butanediol 1.16 kg 2. GBL Dehydrogenation Catalyst 0.001 kg 111
Case No.:24/51/82ALC4/2010
Party Name:BALAJI AMINES LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01741/AM11/ RLA File :31/24/040/00128/AM11/ Lic.No/Date:3110046569 24.01.2011 Defer Date:17.05.2011 Decision : Committee decided to defer case for 17.05.2011 for comments of Department of C&PC. 112
Case No.:25/51/82ALC4/2010
Party Name:BALAJI AMINES LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01742/AM11/ RLA File :31/24/040/00147/AM11/ Lic.No/Date:3110046572 24.01.2011 Defer Date:17.05.2011 Decision : Committee decided to defer case for 17.05.2011 for comments of Department of C&PC. 113 Case No.:3/45/82ALC4/2010 Party Name:MEDREICH LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/01543/AM11/ RLA File :07/24/040/00433/AM11/ Lic.No/Date:0710076954 27.01.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 21/82 meeting held on 25.09.2007 and in consultation with technical authorities present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed
Doxycycline Capsules 100 mg 1 No. 1. Doxycycline Hydrochloride Hemihydrate (Doxycycline Hyclate) 108.06 mg/tablet 114
Case No.:49/47/82ALC4/2010
Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/01639/AM11/ RLA File :03/94/040/00920/AM11/ Lic.No/Date:0310613412 31.01.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/77/2004 Ch.II dated 05.11.2009 and in consultation with technical authorities present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or Export product Exp. Qty. Sl.No. Import items Qty. allowed Hamber (7Acetyl1,2,3,4,5,6,7,8 Octahydro 1,1,6,7Tetramethyl Naphthalne) 1 Kg. 1. Myrcene 1.00 kg 2. 3Methyl3Penten2 one (MPO) 0.600 kg 115
Case No.:51/47/82ALC4/2010
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 22.03.2011 Status:Case Approved HQ File :01/82/050/01641/AM11/ RLA File :07/24/040/00424/AM11/ Lic.No/Date:0710077027 31.01.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 47/11 meeting held on 22.02.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Export Qty. Sl.No. Import items Qty. allowed Kanamycin Acid Sulphate for Inj. BP 1 gm Vial Size:10 ml 1 Vial 1. Kanamycin Acid Sulphate Sterile BP 1.466 gram 116
Case No.:6/51/82ALC4/2010
Party Name:LAKELAND CHEMICALS (INDIA) LTD. 22.03.2011 Status:Case Deferred HQ File :01/82/050/01723/AM11/ RLA File :03/95/040/00807/AM11/ Lic.No/Date:0310613564 01.02.2011 Defer Date:17.05.2011 Decision : Committee decided to defer case for 17.05.2011 for comments of Department of C&PC. 117 Case No.:8/51/82ALC4/2010 Party Name:SALVI CHEMICAL INDUSTRIES LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/01725/AM11/ RLA File :03/95/040/00659/AM11/ Lic.No/Date:0310614170
03.02.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/72/2005 Ch.II dated 29.03.2010 and in consultation with technical authorities present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or Export product Exp. Qty. Sl.No. Import items Qty. allowed 3,5, DiIodo Salicylic Acid 1 Kg. 1. Salicylic Acid 0.414 kg 2. Iodine Crude 0.762 kg 118
Case No.:9/51/82ALC4/2010
Party Name:SALVI CHEMICAL INDUSTRIES LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/01726/AM11/ RLA File :03/95/040/00655/AM11/ Lic.No/Date:0310614172 03.02.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/72/2005 Ch.II dated 29.03.2010 and in consultation with technical authorities present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or Export product Exp. Qty. Sl.No. Import items Qty. allowed 3,5, DiIodo Salicylic Acid 1 Kg. 1. Salicylic Acid 0.414 kg 2. Iodine Crude 0.762 kg 119
Case No.:5/51/82ALC4/2010
Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/01722/AM11/ RLA File :52/24/040/00039/AM11/ Lic.No/Date:5210033910 04.02.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/118/2004 Ch.III dated 16.09.2008 and in consultation with technical authorities present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed 2(3Amino Phenyl Sulfonamide) Naphthalene 6,8 Disulfonic Acid 1 Kg. 1. Beta Naphthol 0.875 kg 120 Case No.:20/51/82ALC4/2010 Party Name:HETERO LABS LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/01737/AM11/ RLA File :09/24/040/00516/AM11/ Lic.No/Date:0910045427 04.02.2011
Decision : Committee considered case as per agenda and in light of written comments of Department of Pharmaceuticals 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: Export product Export Qty. Sl.No. Import items Qty. allowed Terbinafine Hcl 1kg. 1. NMethyl1Naphthalene Methanamine Hydrochloride 1.14 kg 2. 1Chloro6,6Dimethyl2Hepten4yne 0.87 kg 3. Methylene Chloride 2.37 kg 4. Dimethyl Formamide 0.85 kg 5. Acetone 1.94 kg 6. Cyclohexane 1.17 kg 7. Diisopropylether 1.30 kg 121
Case No.:21/51/82ALC4/2010
Party Name:HETERO LABS LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/01738/AM11/ RLA File :09/24/040/00517/AM11/ Lic.No/Date:0910045431 04.02.2011 Decision : Committee considered case as per agenda and in light of written comments of Department of Pharmaceuticals 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: Export product Export Qty. Sl.No. Import items Qty. allowed Capecitabine 1kg. 1. 2,3DiOAcetyl5,Deoxy5Fluorocytidine 1.527 kg 2. Methylene Chloride 4.70 kg 3. Methanol 0.82 kg 122 Case No.:16/47/82ALC4/2010 Party Name:RANBAXY LABORATORIES LTD 22.03.2011 Status:Case Approved HQ File :01/82/050/01606/AM11/ RLA File :05/24/040/00367/AM11/ Lic.No/Date:0510283436 08.02.2011 Decision : Committee considered case as per agenda and in light of written comments of Department of Pharmaceuticals 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: Export product Export Qty. Sl.No. Import items Qty. allowed Doxycycline Monohydrate 1kg. 1. Acetone 1.867 kg 2. Activated Carbon 0.100 kg 3. Cyclohexane 0.085 kg 4. Isopropyl Alcohol 0.931 kg 5. Methanol 2.722 kg 6. Oxytetracycline Hydrochloride 2.18 kg
Rhodium Sponge 0.048 gram 8. Triethylamine 0.50 kg 9. Triphenyl Phosphine 0.025 kg 123
Case No.:7/51/82ALC4/2010
Party Name:LUPIN LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01724/AM11/ RLA File :03/95/040/00869/AM11/ Lic.No/Date:0310614766 08.02.2011 Defer Date:17.05.2011 Decision : Committee considered case as per agenda and decided to ask the firm to indicate whether the export product Ramipril is being manufactured through Noninfringing process and if there is noninfringing process, the firm may furnish production and consumption data certified by Central Excise Authority. Accordingly, case was deferred for 17.05.2011. 124
Case No.:31/47/82ALC4/2010
Party Name:VIVIMED LABS LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01621/AM11/ RLA File :09/24/040/00510/AM11/ Lic.No/Date:0910045498 09.02.2011 Defer Date:17.05.2011 Decision : Committee decided to defer case for 17.05.2011 for comments of Department of C&PC. 125
Case No.:36/47/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01626/AM11/ RLA File :09/24/040/00509/AM11/ Lic.No/Date:0910045516 11.02.2011 Defer Date:17.05.2011 126
Case No.:40/47/82ALC4/2010
Party Name:PERKIN LABORATORIES 22.03.2011 Status:Case Deferred HQ File :01/82/050/01630/AM11/ RLA File :09/24/040/00460/AM10/ Lic.No/Date:0910045524 11.02.2011 Defer Date:17.05.2011 127 Case No.:40/51/82ALC4/2010 Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/01757/AM11/ RLA File :52/24/040/00048/AM11/ Lic.No/Date:5210034176 21.02.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/45/2010 Ch.II dated 27.09.2010 and in consultation with technical authorities present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or Export product Exp. Qty. Sl.No. Import items Qty. allowed
7Amino1Naphthol3,6Disulfonic Acid 1 Kg. 1. K Acid 2.500 kg 128
Case No.:41/51/82ALC4/2010
Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/01758/AM11/ RLA File :52/24/040/00049/AM11/ Lic.No/Date:5210034177 21.02.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/118/2004 Ch.III dated 18.05.2010 and in consultation with technical authorities present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed 2Carbethoxy Amino5Naphthol7 Sulphonic Acid 1 Kg. 1. J Acid 0.904 kg 129 Case No.:1/51/82ALC4/2010 Party Name:CADILA HEALTHCARE LTD., 22.03.2011 Status:Case Approved HQ File :01/82/050/01718/AM11/ RLA File :08/24/040/00328/AM11/ Lic.No/Date:0810096696 28.02.2011 Decision : Committee considered case as per agenda and in light of written comments of Department of Pharmaceuticals and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl. No. Import items Qty. allowed Venlafaxine ER 37.5 mg Capsule 1No. 1. Venlafaxine Hcl 43.277 mg 2. Microcrystalline Cellulose NF 51.385 mg 3. Polyacrylate Dispersion 30 Percent 1H 30.603 mg 4. Isopropyl Alcohol USP 36.928 mg 5. 60 CC White HDPE Bottle As per packing policy 6. CRC White Cap 33 MM As per packing policy 7. 100 CC White HDPE Bottle As per packing policy 8. CRC White Cap 38 MM As per packing policy Venlafaxine ER 75 mg Capsule 1 No. 1. Venlafaxine Hcl 86.552 mg 2. Microcrystalline Cellulose NF 102.769 mg 3. Polyacrylate Dispersion 30 Percent 1H 61.206 mg 4. Isopropyl Alcohol USP 73.857 mg
60 CC White HDPE Bottle As per packing policy 6. CRC White Cap 33 MM As per packing policy 7. 100 CC White HDPE Bottle As per packing policy 8. CRC White Cap 38 MM As per packing policy Venlafaxine ER 150 mg Capsule 1 No. 1. Venlafaxine Hcl 173.10 mg 2. Microcrystalline Cellulose NF 205.538 mg 3. Polyacrylate Dispersion 30 Percent 1H 122.411 mg 4. Isopropyl Alcohol USP 147.71 mg 5. 60 CC White HDPE Bottle As per packing policy 6. CRC White Cap 33 MM As per packing policy 7. 100 CC White HDPE Bottle As per packing policy 8. CRC White Cap 38 MM As per packing policy 130
Case No.:2/51/82ALC4/2010
Party Name:BALAJI AMINES LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/01719/AM11/ RLA File :31/24/040/00261/AM11/ Lic.No/Date:3110047134 28.02.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/113/2008/ Ch.II dated 26.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or Export product Exp. Qty. Sl.No. Import items Qty. allowed NMethyl2Pyrrolidone 1 KG 1. Methanol 0.377 kg 2. Ammonia 0.164 kg 3. 1,4 Butanediol 1.01 kg 4. Methylamine Catalyst 0.00080 kg 5. GBL Catalyst 0.00075 kg RA concerned may take further necessary action as per above decision of NC 131 Case No.:3/51/82ALC4/2010 Party Name:OTSUKA CHEMICAL ( INDIA ) PRIVATE LIMITED 22.03.2011 Status:Case Approved
HQ File :01/82/050/01720/AM11/ RLA File :05/24/040/00397/AM11/ Lic.No/Date:0510284821 01.03.2011 Decision :Committee decided to close the case as Advance Authorisation has been issued under para 4.7.1 of HBP. 132
Case No.:4/51/82ALC4/2010
Party Name:OTSUKA CHEMICAL ( INDIA ) PRIVATE LIMITED 22.03.2011 Status:Case HQ File :01/82/050/01721/AM11/ RLA File :05/24/040/00403/AM11/ Lic.No/Date:0510284822 01.03.2011 Defer Date: Decision : Committee decided to close the case as Advance Authorisation has been issued under para 4.7.1 of HBP. 133
Case No.:27/51/82ALC4/2010
Party Name:SUVEN LIFE SCIENCES LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/01744/AM11/ RLA File :09/24/040/00543/AM11/ Lic.No/Date:0910045757 01.03.2011 Decision : Committee considered case as per agenda and in light of its earlier decision taken in its 35/82 meeting held on 30.11.2010 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: Export product Export Qty. Sl.No. Import items Qty. allowed 5Cyano Phthalide 1kg. 1. Sulfolane 6.184 kg 2. Sulfamide 1.020 kg 3. Para Formaldehyde 0.53 kg 134
Case No.:29/51/82ALC4/2010
Party Name:HETERO LABS LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/01746/AM11/ RLA File :09/24/040/00548/AM11/ Lic.No/Date:0910045759 01.03.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 45/82 meeting held on 08.02.2011 and in consultation with representative of Department of Pharmaceuticals 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 Quetiapine Hemifumarate 1 kg 1. 1[2(2Hydroxyethoxy)Ethyl]Piperazine 0.714 kg 2. Toluene 1.40 kg 3. Methanol 1.06 kg 4. Dibenzo(1,4)Thazepine11(10H)one 0.80 kg 5. Phosphorous Oxychloride 0.50 kg
135
Case No.:38/51/82ALC4/2010
Party Name:PARABOLIC DRUGS LTD., 22.03.2011 Status:Case Approved HQ File :01/82/050/01755/AM11/ RLA File :05/24/040/00400/AM11/ Lic.No/Date:0510284826 01.03.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/273/2009PI (Norms) dated 30.04.2010 and in consultation with technical authorities present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Cefixime Trihydrate 1 Kg. 1. 7 Phenylacetamideo3Chloromethyl Cephalosporanic Acid Para Methoxybenzyl Ester (GCLE) 1.555 kg 2. Triphenyl Phosphine 1.22 kg 3. Activated Carbon 0.100 kg 4. Actone 10.93 kg 5. Methylene Chloride 0.647 kg 6. Methanol 6.708 kg 7. 2Mercaptobenzothiazoyl(Z)2(2 Aminothazole4yl)2 (Methoxycarbonymethoyimino acetate MICA Easter) 0.820 kg 136
Case No.:39/51/82ALC4/2010
Party Name:PARABOLIC DRUGS LTD., 22.03.2011 Status:Case Approved HQ File :01/82/050/01756/AM11/ RLA File :05/24/040/00410/AM11/ Lic.No/Date:0510284827 01.03.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/205/2009PI(Norms) dated 20.01.2010 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: Export product Exp. Qty. Sl.No. Import items Qty. allowed Ceftriaxone Sodium Sterile 1 Kg. 1. Ceftriaxone Sodium (Non Sterile) 1.04 kg 2. Acetone 1.72 kg 3. Eno Carbon 51.66 gm 137 Case No.:11/51/82ALC4/2010 Party Name:IPCA LABORATORIES LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01728/AM11/ RLA File :03/94/040/01049/AM11/ Lic.No/Date:0310619151 03.03.2011 Defer Date:17.05.2011
Decision :Committee decided to defer case for 17.05.2011 for comments of Department of Pharmaceuticals. 138
Case No.:12/51/82ALC4/2010
Party Name:KUSUMA PHARMA 22.03.2011 Status:Case Deferred HQ File :01/82/050/01729/AM11/ RLA File :03/94/040/01067/AM11/ Lic.No/Date:0310619161 03.03.2011 Defer Date:19.04.2011 Decision : Committee decided to defer case for 19.04.2011 for comments of Department of C&PC. 139
Case No.:13/51/82ALC4/2010
Party Name:PI INDUSTRIES LTD., 22.03.2011 Status:Case Approved HQ File :01/82/050/01730/AM11/ RLA File :13/24/040/00038/AM11/ Lic.No/Date:1310034755 03.03.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.15022/6/2010 Ch.II dated 18.05.2010 and in consultation with technical authorities present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or Export product Exp. Qty. Sl.No. Import items Qty. allowed AE473 (2{2Chloro4mesyl3 [(RS)}tetrahydro2 furylmethoxymethyl}benzoyl) cyclohexane1,3Dione) Min.97%) 1 Kg. 1. 3Chloro2Methyl Aniline 0.746 kg 2. Methanol 3.380 kg 3. Toluene 3.190 kg 4. Bromine 1.404 kg 5. Tetrahydrofurfuryl Alcohol 2.170 kg 6. 1,3Cyclohexanedione 0.357 kg 7. Acetonitrile (Methyl Cyanide) 1.068 kg 8. Caustic Soda Lye (47%) 4.096 kg 140 Case No.:30/51/82ALC4/2010 Party Name:KAMUD DRUGS PVT.LIMITED., 22.03.2011 Status:Case Approved HQ File :01/82/050/01747/AM11/ RLA File :31/24/040/00271/AM11/ Lic.No/Date:3110047186 03.03.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/110/2010PI (Norms) dated 18.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Ketamine Hcl 1 Kg. 1. Cyclo Pentyl Chloride 1.876 kg 2. O Chloro Benzonitril 1.684 kg 3. Magnesium Turning 0.467 kg 4. Bromoine 1.83 kg 5. Methanol 6.81 kg 6. Toluene 10.32 kg
Acetone 0.031 kg 8. Iso Propyl Alcohol 2.71 kg 141
Case No.:31/51/82ALC4/2010
Party Name:MASS DYECHEM PVT LTD., 22.03.2011 Status:Case Deferred HQ File :01/82/050/01748/AM11/ RLA File :31/24/040/00263/AM11/ Lic.No/Date:3110047188 03.03.2011 Defer Date:19.04.2011 Decision : Committee decided to defer case for 19.04.2011 for comments of Department of C&PC. 142
Case No.:32/51/82ALC4/2010
Party Name:PERKIN LABORATORIES 22.03.2011 Status:Case Approved HQ File :01/82/050/01749/AM11/ RLA File :09/24/040/00251/AM11/ Lic.No/Date:0910045763 03.03.2011 Defer Date: 143
Case No.:33/51/82ALC4/2010
Party Name:PERKIN LABORATORIES 22.03.2011 Status:Case Deferred HQ File :01/82/050/01750/AM11/ RLA File :09/24/040/00541/AM11/ Lic.No/Date:0910045764 03.03.2011 Defer Date:17.05.2011 144
Case No.:34/51/82ALC4/2010
Party Name:PERKIN LABORATORIES 22.03.2011 Status:Case Deferred HQ File :01/82/050/01751/AM11/ RLA File :09/24/040/00503/AM11/ Lic.No/Date:0910045771 03.03.2011 Defer Date:17.05.2011 145
Case No.:35/51/82ALC4/2010
Party Name:PERKIN LABORATORIES 22.03.2011 Status:Case Approved HQ File :01/82/050/01752/AM11/ RLA File :09/24/040/00062/AM11/ Lic.No/Date:0910045773 03.03.2011 Defer Date: 146 Case No.:36/51/82ALC4/2010 Party Name:PERKIN LABORATORIES 22.03.2011 Status:Case Deferred HQ File :01/82/050/01753/AM11/ RLA File :09/24/040/00449/AM11/ Lic.No/Date:0910045776 03.03.2011 Defer Date:17.05.2011
p 147
Case No.:37/51/82ALC4/2010
Party Name:PERKIN LABORATORIES 22.03.2011 Status:Case Deferred HQ File :01/82/050/01754/AM11/ RLA File :09/24/040/00074/AM11/ Lic.No/Date:0910045777 03.03.2011 Defer Date:17.05.2011 148
Case No.:42/51/82ALC4/2010
Party Name:MSN LABORATORIES LIMITED 22.03.2011 Status:Case Approved HQ File :01/82/050/01759/AM11/ RLA File :09/24/040/00538/AM11/ Lic.No/Date:0910045801 04.03.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/82/2010PI (Norms) dated 01.10.2011 and in consultation with representative of Department of Pharmaceuticals 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 Rosuvastatin Calcium 1 kg 1. (4RCis)6((Acetyloxy)Methyl)2,2 Dimethyl1,3Dioxane4Acetic Acid1,1 Dimethylethyl Ester 1.871 kg 2. 4(4Fluorophenyl)6Isopropyl2[(NMethyl NMethylsulphonyl)Amino]Pyrimidine5YL Methanol 1.871 kg 149
Case No.:43/51/82ALC4/2010
Party Name:MEDCHL CHEMICALS AND PHARMACEUTICALS PVT LTD 22.03.2011 Status:Case Deferred HQ File :01/82/050/01760/AM11/ RLA File :09/24/040/00539/AM11/ Lic.No/Date:0910045802 04.03.2011 Defer Date:17.05.2011 150 Case No.:44/51/82ALC4/2010 Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. 22.03.2011 Status:Case Approved HQ File :01/82/050/01761/AM11/ RLA File :31/24/040/00267/AM11/ Lic.No/Date:3110047211 04.03.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/6/2009 Ch.II dated 28.02.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or Export Product Export Qty. Sl.No. Import items Qty. allowed Monomethyl Ether of Hydroquinone MEHQ 1 KG. 1. Phenol 1.19 kg 2. Dimethyl Sulphate 0.640 kg 3. Caustic Soda Flakes 0.415 kg
g 4. Hydrogen Peroxide (50%) 0.610 kg 5. Acetone 0.300 kg 151
Case No.:45/51/82ALC4/2010
Party Name:EMCURE PHARMACEUTICALS LTD. 22.03.2011 Status:Case Approved HQ File :01/82/050/01762/AM11/ RLA File :31/24/040/00270/AM11/ Lic.No/Date:3110047212 04.03.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 49/82 meeting held on 08.03.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Ciprofloxacin Tablets 500 mg 1 No. 1. Ciprofloxacin Hcl 555.0 mg 152
Case No.:46/51/82ALC4/2010
Party Name:HETERO LABS LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01763/AM11/ RLA File :09/24/040/00544/AM11/ Lic.No/Date:0910045817 07.03.2011 Defer Date:17.05.2011 Decision :Committee decided to defer case for 17.05.2011 for comments of Department of Pharmaceuticals. 153
Case No.:47/51/82ALC4/2010
Party Name:SHASUN PHARMACEUTICALS LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01764/AM11/ RLA File :04/24/040/00321/AM11/ Lic.No/Date:0410122330 08.03.2011 Defer Date:17.05.2011 154
Case No.:52/51/82ALC4/2010
Party Name:IPCA LABORATORIES LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01769/AM11/ RLA File :03/94/040/01002/AM11/ Lic.No/Date:0310620013 08.03.2011 Defer Date:17.05.2011 155
Case No.:48/51/82ALC4/2010
Party Name:ADVANCE PETROCHEMICALS LIMITED 22.03.2011 Status:Case Deferred HQ File :01/82/050/01765/AM11/ RLA File :08/24/040/00374/AM11/ Lic.No/Date:0810097060 09.03.2011 Defer Date:19.04.2011 Decision : Committee decided to defer case for 19.04.2011 for comments of Department of C&PC.
156
Case No.:49/51/82ALC4/2010
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 22.03.2011 Status:Case Deferred HQ File :01/82/050/01766/AM11/ RLA File :04/24/040/00333/AM11/ Lic.No/Date:0410122404 09.03.2011 Defer Date:17.05.2011 157
Case No.:50/51/82ALC4/2010
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 22.03.2011 Status:Case Deferred HQ File :01/82/050/01767/AM11/ RLA File :04/24/040/00335/AM11/ Lic.No/Date:0410122405 09.03.2011 Defer Date:17.05.2011 158
Case No.:51/51/82ALC4/2010
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 22.03.2011 Status:Case Deferred HQ File :01/82/050/01768/AM11/ RLA File :04/24/040/00334/AM11/ Lic.No/Date:0410122406 09.03.2011 Defer Date:17.05.2011
Case No.Outside Agenda1
M/S Cipla Ltd. F.No.01/82/050/00264/AM09/DESIII RA F.No.03/94/040/01232/AM08 Adv.Lic.No.0310464263 dated 10.03.2008 Committee considered case and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/83/2007PIIII dated Nil and U.O. No.35011/168/2008PIIII dated 24.11.2008 and in consultation with technical authority present in meeting, decided to revise 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 Lamivir 150mg tablet [Lamivudine =153.0 mg/tablet] 1 No. 1. (1’R,2’S,5’R)Menthyl5S (Cytosine1” YL)1,3Oxathiolane2R carboxylate/CME compound 2.19 kg/kg of Lamivudine Lamivir S30 tablet [Lamivudine =153.0 mg/tablet] [Stavudine =30.6 mg/tablet] 1 No. Lamivir S40 tablet [Lamivudine 153.0 mg/tablet] [Stavudine= 40.8 mg/tablet] 1 No. 2. Sodium Borohydride 0.48 kg/kg of Lamivudine Lamivir S Junior tablet [Lamivudine 61.20 mg/tablet] [Stavudine= 12.24 mg 1 No. 3. Dipotassium Hydrogen Phosphate 2.582 kg/kg of Lamivudine 4. 2’,3’Dihydro,5’O Benzoyl,5Methyl Uridine 2.00 kg/kg of Stavudine Lamivir S Baby Tablet 1 No.
[Lamivudine 30.6 mg/tablet] [Stavudine= 6.12 mg/tablet 5. Butyl Acetate 2.09 kg/kg of Stavudine Lamivir HBV Tablet [Lamivudine=102.20 mg] 1 No.
Case No.Outside Agenda2
M/S Cipla Ltd. F.No.01/82/050/00476/AM09/DESIII RA F.No.03/94/040/00085/AM09 Adv.Lic.No.0310469925 dated 29.04.2008 Committee considered case and in light of earlier decision taken in 7/11 meeting held on 18.05.2010 and in consultation with technical authority present in meeting, decided to allow import of Dipotassium Hydrogen Phosphate to the extent of 2.582 kg/kg of Lamivudine without any other change in the decision taken in 12/82 meeting held on 17.06.2008.
Case No.Outside Agenda3
M/S Cipla Ltd. F.No.01/82/050/00501/AM10/DESIII F.No.01/82/050/01032/AM10/DESIII F.No.01/82/050/01033/AM10/DESIII RA F.No.03/94/040/00454/AM10 RA F.No.03/94/040/00821/AM10 RA F.No.03/94/040/00865/AM10 Adv.Lic.No.0310535251 dated 26.08.2009 Adv.Lic.No.0310552339 dated 23.12.2009 Adv.Lic.No.0310554460 dated 08.01.2010 Committee considered case and in consultation with technical authority present in meeting, decided to amend the description of import item to read as “2Amino1,9dihydro9[(1S,3R,4S)4(Benzyloxy)3 (Benzyloxymethyl)2Methylenecyclopentyl]6Hpurin6one ECR4]” without any other change in the earlier decisions taken by NC.
Case No.Outside Agenda4
M/S Cipla Ltd. F.No.01/82/050/00057/AM10/DESIII
RA F.No.03/94/040/00031/AM10 Adv.Lic.No.0310517566 dated 28.04.2009 Committee considered case and in consultation with technical authority present in meeting, decided to amend the description of export product No.2 and 3 to read as “GCS Max Powder” without any other change in the decision taken in 6/82 meeting held on 12.05.2009.
Case No.Outside Agenda5
M/S Cipla Ltd. F.No.01/82/050/01185/AM10/DESIII F.No.01/82/050/00737/AM11/DESIII RA F.No.03/94/040/01036/AM10 RA F.No.03/94/040/01036/AM10 Adv.Lic.No.0310562806 dated 03.03.2010 Adv.Lic.No.0310582173 dated 06.07.2010 Committee considered case and in consultation with technical authority present in meeting, decided to amend the description of export product to read as “Sulfamethazine & Trimethoprim Oral Powder/Cobact Powder” without any other change in the decision taken in 52/82 meeting held on 23.03.2010 and 22/82 meeting held on 31.08.2010.
Case No.Outside Agenda6
M/S Cipla Ltd. F.No.01/82/050/00936/AM09/DESIII F.No.01/82/050/00961/AM09/DESIII RA F.No.03/94/040/00073/AM09 RA F.No.03/94/040/00555/AM09 Adv.Lic.No.0310468658 dated 16.04.2008 Adv.Lic.No.0310484907 dated 02.09.2008 Committee considered case and in consultation with technical authority present in meeting, decided to amend the UOM of import item No.5 i.e. “HFA227 Propellant (1,1,1,2,3,3,3Heptafluoropropane Gas)” to read as “21.12 gram” without any other change in the decision taken in 52/82 meeting held on 17.03.2009.
Case No.Outside Agenda7
M/S Cipla Ltd. F.No.01/82/050/00421/AM11/DESIII RA F.No.03/94/040/00186/AM11 Adv.Lic.No.0310575233 dated 20.05.2010 Committee considered case and in consultation with technical authority present in meeting, decided to revise norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed
Ipratropium Bromide 20 mcg inhaler (200MD) with 50 mcl Aerosol Valves 1 No. 1. Ipratropium Bromide 4.00 mg 2. 50 mcl Aerosol valve As per packing policy 3. 19 ml Aluminium Can 4. Activators with dust covers/caps fitting to 19ml Aluminium can 5. HFA227 Propellant (1,1,1,2,3,3,3 Heptafluoropropane gas) 16.76 gram Salbutamol 100 mcg and Ipratropium Bromide 20 mcg inhaler (200MD) with 50 mcl Aerosol valves 1 No. 1. Sulbutamol 20.00 mg 2. Ipratropium Bromide 4.00 mg 3. 19 ml Aluminium Can As per packing policy 4. 50 mcl Aerosol valve 5. Activators with dust covers/caps fitting to 19ml Aluminium can 6. HFA227 Propellant (1,1,1,2,3,3,3 Heptafluoropropane gas) 16.76 gram Budesonide 100 mcg inhaler (200MD) with 50 mcl Aerosol valves 1 No. 1. Budesonide 20.00 mg 2. 50 mcl Aerosol valve As per packing policy 3. 19 ml Aluminium Can 4. Activators with dust covers/caps fitting to 19ml Aluminium can 5. HFA227 Propellant (1,1,1,2,3,3,3 Heptafluoropropane gas) 16.76 gra, Budesonide 200 mcg inhaler (200MD) with 50 mcl Aerosol valves 1 No. 1. Budesonide 40.00 mg 2. 50 mcl Aerosol valve As per packing policy 3. 19 ml Aluminium Can 4. Activators with dust covers/caps fitting to 19ml Aluminium can 5. HFA227 Propellant (1,1,1,2,3,3,3 Heptafluoropropane gas) 16.76 gram
Case No.Outside Agenda8
M/S Best Value Chem Pvt. Ltd. F.No.01/82/050/01584/AM07/DESIII
F.No.01/83/050/01002/AM08/DESIII F.No.01/82/050/01153/AM09/DESIII F.No.01/82/050/01424/AM09/DESIII RA F.No.34/24/040/00224/AM07 RA F.No.34/24/040/00099/AM08 RA F.No.34/24/040/00130/AM09 RA F.No.34/24/040/00156/AM09 Adv.Lic.No.3410017898 dated 18.01.2007 Adv.Lic.No.3410019462 dated 21.08.2007 Adv.Lic.No.3410022514 dated 14.10.2008 Adv.Lic.No.3410022945 dated 17.12.2008 Committee considered case and in view of clarifications furnished by the firnished by the firm vide their letter dated 17.01.2011, the Committee decided to amend the description of export product as “Amyl Salicylate” and of import items as “Pentanol Mixture” and “Salicylic Acid”. There will be no change in quantities allowed by NC.
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