DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi ‐0 ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
Para 4.7 Decision(DRAFT)
MEETING NUMBER : 44/82‐ALC4/2010 MEETING DATE : 01.02.2011 The Meeng No.44/82 in the year 2010‐11 to consider the cases under Duty Exempon Scheme (Chapter‐4) of Foreign Trade Policy, 2009‐14 pertaining to products falling in Chapter 29 and 30 was held on 01.02.2011 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present:‐ 1. Shri Jasbir Singh, I.A., Department of C&PC 2. Shri M. Mitra, Dy, DCGI, DCGI 3. Shri Shaish Kumar, IA, DIPP 4. Shri D.N. Mathur, Dy.I.A, Department of Pharmaceucals 5. Shri Krishan Kumar, Dy. DGFT 6. Shri Shyam Lal, FTDO
Case No. B‐365
M/s Pab Organic Pvt. Ltd. Norms Commi쏧ee Meeng No. 44/11 F.No.01/82/050/01042/AM10/DES‐III F.No.01/82/050/01119/AM10/DES‐III Meeng Date 01.02.2011 RA F.No. 34/24/040/00154/AM10 RA F.No. 34/24/040/00153/AM10 Adv. Lic. No.3410025955 dt. 22.12.09 Adv. Lic. No.3410025954 dt. 22.12.09 Commi쏧ee considered case as per agenda The Managing Director of the company appeared before the Commi쏧ee and explained the case. He informed the Commi쏧ee that he is the only manufacturer of 5 Cyano Phthalide and during manufacturing the export product, praccal yield is very low. A챦er detailed deliberaons and in view of wri쏧en comments of Department of Pharmaceucicals and in consultaon with technical authority present in meeng, Commi쏧ee decided to rafy revise 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 5 Cyano Phthalide 1 Kg. 1. 5 Amino Phthalide 1.50 kg RA concerned may take further necessary acon as per above decision of NC.
Case No. B‐366
M/s Prachi Pharmaceucals Pvt. Ltd. F.No.01/83/050/01323/AM09/DES‐III F.No.01/82/162/01008/AM10/DES‐III RLA F. No. 03/95/040/00723/AM09
RLA F. No. 03/95/040/00404/AM07 Adv. Lic. No.0310508539 dated 20.02.2009 Adv. Lic. No.0310390437 dated 28.07.2006 Commi쏧ee considered case as per agenda and observed that SION for the export product Povidone Iodine Powder are available at Sl.No.A‐367 which meant for 100% Povidone Iodine Powder while the firm has obtained advance authorizaon for export of Povidone Iodine 20% powder and therefore norms has been fixed correctly on pro‐rata basis. According, in consultaon with technical authority present in meeng, Commi쏧ee decided to amend the descripon of export product to read as “Povidone Iodine 20% Powder” without any other change in the decision taken in 42/82 meeng held on 12.01.2010.
Case No. B‐367
M/s Glenmark Pharma Ltd. F.No.01/82/050/00212/AM11/DES‐III RLA F. No. 03/94/040/00146/AM11 Adv. Lic. No.0310574318 dated 14.05.2010 Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M. No.35011/142/2010‐PI (Norms) dated 06.12.2010 and in consultaon with technical authority present in meeng decided to rafy 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 Erbumins 1 kg. 1. 2(S)‐Indoline‐2‐Carboxylic acid 0.947kg 2. Methanol 1.43 kg 3. Toluene 3.22 kg 4. Methylene Chloride/Methylene Dichloride/MDC 15.19 kg 5. L‐Norvaline 1.423 kg 6. Acetonitrile 3.57 kg 7. Sodium Pyruvate 1.42 kg
Case No. B‐368
M/s Emami Ltd. F.No.01/82/050/00808/AM09/DES‐III RLA F. No. 02/24/040/00183/AM08 Adv. Lic. No.0210106154 dated 19.11.2007 Commi쏧ee considered case as per agenda and in consultaon with technical authority present in meeng decided to allow import of Ozokirite Wax Melng Point 70‐85 degree to the extent of 0.09 kg/kg of export product without any other change in the decision taken in 52/82 meeng held on 17.03.2009.
RA concerned may take further necessary acon as per above decision of NC
Case No. B‐369
M/s FDC Ltd. F.No.01/82/162/00315/AM04/DES‐III RLA F. No. 03/94/040/00781/AM01 Adv. Lic. No.0310072318 dated 08.02.2001 Commi쏧ee considered case as per agenda and in light of earlier decision taken in 32/2003 meeng held on 27.11.2002 and in consultaon with technical authority present in meeng, decided to rafy 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 Timolol Maleate 1 kg 1. Dimethoxy Propane 2.05 kg 2. 7‐Butylanine 1.20 kg 3. Sodium Borohydride 0.17 kg 4. Sodium Hydride 0.26 kg
Case No. B‐370
M/s Hindustan Polyamides & Fibres Ltd. F.No.01/83/050/00875/AM07/DES‐III RLA F. No.03/94/040/00577/AM07 Adv. Lic. No.0310398486 dated 07.09.2006 Commi쏧ee considered case as per agenda and in consultaon with technical authority present in meeng decided to amend the descripon of export product to read as “Menthanol (4‐Isopropyl Cyclohexyl)” without any other change in the decision taken in 41/08 meeng held on 16.01.2008. RA concerned may take further necessary acon as per above decision of NC
Case No. B‐371
M/s Vins Bioproducts Ltd. F.No.01/82/162/00939/AM11/DES‐III Commi쏧ee considered case as per agenda and decided to refer the case to Department of Bio‐technology for their comments under inmaon to PC‐IV(B) Secon. Accordingly case was deferred for 29.03.2011.
Case No. B‐372
M/s Aurobindo Pharma Ltd. F.No.01/82/050/00071/AM11/DES‐III
F.No.01/82/050/01250/AM10/DES‐III RLA F. No. 09/24/040/00264/AM10 RLA F. No. 09/24/040/00461/AM10 Adv. Lic. No.0910039746 dated 28.10.2009 Adv. Lic. No.0910041036 dated 22.02.2010 Commi쏧ee considered case as per agenda and in consultaon with technical authority present in meeng decided to descripon and quanty of import item No.8 to read as “Mica Ester” and to allow its quanty as 0.82 kg/kg of export product. The Commi쏧ee also dicided to allow import of Iodine as applied by the firm without any other change in the decision taken in 5/82 meeng held on 04.05.2010 and 6/82 meeng held on 11.05.2010. RA concerned may take further necessary acon as per above decision of NC
Case No. B‐373
M/s GVS Ltd. F.No.01/82/050/001367/AM07/DES‐III F.No.01/82/050/001368/AM07/DES‐III RLA F. No. 03/94/040/00842/AM07 RLA F. No. 03/94/040/00843/AM07 Adv. Lic. No.0310410371 dated 30.11.2006 Adv. Lic. No.0310410389 dated 30.11.2006 Commi쏧ee considered case as per agenda. The representaves of the company appeared before the Commi쏧ee and explained the case. They clarified the rao of both the import items and export product. They also informed the Commi쏧ee that there was certain administrave problems in their company and therefore they could not make representaon earlier. A챦er detailed deliberaons and in consultaon with technical authority present in meeng, Commi쏧ee decided to rafy rafy 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 Clavumoccid 125 Oral Suspension in 60 ml Bo쏧le containing Amoxicilline Trihydrate 88.81% and Clavulanate Potassium 11.19%) 40000 Nos. 1. Amoxicilline Trihydrate 88.81% and Clavulanate Potassium 11.19% Mixed form 74.93 kg Clavumoccid 250 Oral Suspension in 60 ml Bo쏧le containing Amoxicilline Trihydrate 88.81% and Clavulanate Potassium 11.19%) 40000 Nos. 1. Amoxicilline Trihydrate 88.81% and Clavulanate Potassium 11.19% Mixed form 149.86 kg
Case No. B‐374
M/s Inderprastha Labs Ltd. F.No.01/82/162/00983/AM11/DES‐III Commi쏧ee considered case as per agenda. The representaves of Department of Pharmaceucals and DCGI informed the Commi쏧ee that Visa Gold is an Ayurvedic Medicament Capsule while Sl. No.42C of DEPB Schedule is applicable for Allopathic Capsule and hence Visa Gold is not covered under the said entry. Accordingly, it was decided to convey the above decision to PC‐IV(B) Secon. 1
Case No.:34/44/82‐ALC4/2010
Party Name:SHODHANA LABORATORIES LTD. Meet No/Date:44/82‐ALC4/2010 01.02.2011 Status:Case Deferred HQ File :01/82/050/01533/AM11/ RLA File :09/24/040/00602/AM08/ Lic.No/Date:0910033919 14.05.2008 Defer Date:29.03.2011 Decision :Commi쏧ee decided to defer case for 29.03.2011 for comments of Department of Pharmaceucals. 2
Case No.:8/7/82‐ALC4/2009
Party Name:MAKSON INDUSTRIES PVT. LTD. 01.02.2011 Status:Case Deferred HQ File :01/82/050/00079/AM10/ RLA File :03/95/040/00025/AM10/ Lic.No/Date:0310518715 06.05.2009 Defer Date:22.02.2011 Decision :Commi쏧ee considered case as per agenda and observed that the firm was requested to appear for personal hearing, but they have requested for postponement of personal hearing for 22.02.2011. It was, therefore, decided to call the firm for personal hearing on 22.02.2011. Accordingly, case was deferred for 22.02.2011. 3
Case No.:7/8/82‐ALC4/2009
Party Name:SHILPA MEDICARE LTD., 01.02.2011 Status:Case Deferred HQ File :01/82/050/00102/AM10/ RLA File :07/24/040/00053/AM10/ Lic.No/Date:0710064718 13.05.2009 Defer Date:01.03.2011 Decision : Commi쏧ee decided to defer case for 01.03.2011 for comments of Department of Pharmaceucals. 4
Case No.:27/34/82‐ALC4/2009
Party Name:VIVIMED LABS LIMITED 01.02.2011 Status:Case Rejected HQ File :01/82/050/00672/AM10/ RLA File :09/24/040/00310/AM10/ Lic.No/Date:0910039804 05.11.2009 Decision :Commi쏧ee considered case as per agenda and observed that the firm was requested to furnish Producon and Consumpon data cerfied by Central Excise Authority vide le쏧er dated 02.08.2010, but the same has not been received and norms can not be fixed in absence of required data. It was, therefore, decided to reject the case.
5
Case No.:21/2/82‐ALC4/2010
Party Name:THERMAX LTD., 01.02.2011 Status:Case Approved HQ File :01/82/050/01255/AM10/ RLA File :31/24/040/00138/AM10/ Lic.No/Date:3110040580 10.11.2009 Decision :Withdrawn as the case has already been approved by NC in its 43/82 meeng held on 25.01.2011. 6
Case No.:66/9/82‐ALC4/2010
Party Name:HETERO LABS LTD. 01.02.2011 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:01.03.2011 7
Case No.:3/43/82‐ALC4/2009
Party Name:ARCH PHARMALABS LTD 01.02.2011 Status:Case Deferred HQ File :01/82/050/00877/AM10/ RLA File :03/94/040/00784/AM10/ Lic.No/Date:0310554371 08.01.2010 Defer Date:01.03.2011 8
Case No.:16/49/82‐ALC4/2009
Party Name:HONEST BIO‐VET PVT. LTD 01.02.2011 Status:Case Deferred HQ File :01/82/050/01151/AM10/ RLA File :08/24/040/00322/AM10/ Lic.No/Date:0810086636 18.02.2010 Defer Date:29.03.2011 Decision : Commi쏧ee decided to defer case for 29.03.2011 for comments of Department of Pharmaceucals. 9
Case No.:17/50/82‐ALC4/2009
Party Name:RANBAXY LABORATORIES LTD 01.02.2011 Status:Case Deferred HQ File :01/82/050/01171/AM10/ RLA File :05/24/040/00486/AM10/ Lic.No/Date:0510259472 25.02.2010 Defer Date:29.03.2011 10
Case No.:26/50/82‐ALC4/2009
Party Name:CENTURY PHARMACEUTICALS LTD. 01.02.2011 Status:Case Deferred Lic.No/Date:3410026508
HQ File :01/82/050/01180/AM10/ RLA File :34/24/040/00208/AM10/ 02.03.2010 Defer Date:01.03.2011 11
Case No.:28/50/82‐ALC4/2009
Party Name:SMILAX LABORATORIES LIMITED 01.02.2011 Status:Case Deferred HQ File :01/82/050/01182/AM10/ RLA File :09/24/040/00446/AM10/ Lic.No/Date:0910041147 03.03.2010 Defer Date:29.03.2011 12
Case No.:47/2/82‐ALC4/2010
Party Name:MEDREICH LIMITED 01.02.2011 Status:Case Deferred HQ File :01/82/050/01281/AM10/ RLA File :07/24/040/00488/AM10/ Lic.No/Date:0710070729 30.03.2010 Defer Date:29.03.2011 13
Case No.:35/2/83‐ALC1/2010
Party Name:ADVY CHEMICAL 01.02.2011 Status:Case Deferred HQ File :01/83/050/00035/AM11/ RLA File :03/94/040/01124/AM10/ Lic.No/Date:0310568188 06.04.2010 Defer Date:29.03.2011 Decision :Commi쏧ee decided to remind Department of Bio‐technology for their comments. Accordingly, the case was deferred for 29.03.2011. 14
Case No.:7/26/82‐ALC4/2010
Party Name:SMILAX LABORATORIES LIMITED 01.02.2011 Status:Case Deferred HQ File :01/82/050/00825/AM11/ RLA File :09/24/040/00061/AM11/ Lic.No/Date:0910042109 25.05.2010 Defer Date:01.03.2011 15
Case No.:8/26/82‐ALC4/2010
Party Name:SMILAX LABORATORIES LIMITED 01.02.2011 Status:Case Deferred HQ File :01/82/050/00826/AM11/ RLA File :09/24/040/00060/AM11/ Lic.No/Date:0910042112 25.05.2010 Defer Date:01.03.2011 16
Case No.:21/26/82‐ALC4/2010
Party Name:VIRCHOW PETROCHEMICAL PVT LTD. 01.02.2011 Status:Case Deferred
HQ File :01/82/050/00839/AM11/ RLA File :09/24/040/00550/AM10/ Lic.No/Date:0910042135 25.05.2010 Defer Date:01.03.2011 17
Case No.:14/31/82‐ALC4/2010
Party Name:HETERO LABS LIMITED 01.02.2011 Status:Case Deferred HQ File :01/82/050/00939/AM11/ RLA File :09/24/040/00086/AM11/ Lic.No/Date:0910042201 01.06.2010 Defer Date:01.03.2011 18
Case No.:77/40/82‐ALC4/2010
Party Name:SHREE VINAYAKA LIFE SCIENCES PVT LTD. 01.02.2011 Status:Case Deferred HQ File :01/82/050/01276/AM11/ RLA File :09/24/040/00512/AM10/ Lic.No/Date:0910042212 02.06.2010 Defer Date:01.03.2011 Decision : Commi쏧ee decided to defer case for 01.03.2011 for comments of Department of C&PC. 19
Case No.:83/40/82‐ALC4/2010
Party Name:SHREE VINAYAKA LIFE SCIENCES PVT LTD. 01.02.2011 Status:Case Deferred HQ File :01/82/050/01282/AM11/ RLA File :09/24/040/00444/AM09/ Lic.No/Date:0910042211 02.06.2010 Defer Date:01.03.2011 20
Case No.:10/18/82‐ALC4/2010
Party Name:VIVEK PHARMACHEM (INDIA) LTD., 01.02.2011 Status:Case Approved HQ File :01/82/050/00553/AM11/ RLA File :13/24/040/00007/AM11/ Lic.No/Date:1310032417 14.06.2010 Decision : Commi쏧ee considered case as per agenda and in consultaon with technical authories present in meeng, decided to rafy norms with 5% wastage 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 Cloxacillin Sodium for Injecon BP 250 mg 100% Potency 2175000 Vials 1. Cloxacillin Sodium (Sterile) BP 570.94 kg 2. Vials Relevant as per packing policy
21
Case No.:11/18/82‐ALC4/2010
Party Name:VIVEK PHARMACHEM (INDIA) LTD., 01.02.2011 Status:Case Approved HQ File :01/82/050/00554/AM11/ RLA File :13/24/040/00012/AM11/ Lic.No/Date:1310032416 14.06.2010 Decision : Commi쏧ee considered case as per agenda and in consultaon with technical authories present in meeng, decided to rafy norms with 5% wastage 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 Hydrocorsone Sodium Succinate for Injecon USP 1000 mg 600000 Vials 1. Hydrocorsone Sodium Succinate Sterile Buffered (Blend of Hydrocorsone Sodium Succinate USP & Sterile Sodium Carbonate 63 kg 2. Vials Relevant as per packing policy 22
Case No.:12/26/82‐ALC4/2010
Party Name:SRINI PHARMACEUTICALS LTD., 01.02.2011 Status:Case Deferred HQ File :01/82/050/00830/AM11/ RLA File :09/24/040/00093/AM11/ Lic.No/Date:0910042310 14.06.2010 Defer Date:01.03.2011 23
Case No.:13/26/82‐ALC4/2010
Party Name:SMILAX LABORATORIES LIMITED 01.02.2011 Status:Case Approved HQ File :01/82/050/00831/AM11/ RLA File :09/24/040/00097/AM11/ Lic.No/Date:0910042361 16.06.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their U.O. No.35011/251/2008‐PI‐III dated 23.04.2009 and in consultaon with technical authority present in meeng, decided to rafy 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 5‐(Difluoromethoxy)‐2‐((3,4‐ Dimethoxypyridin‐2‐ YL)Methylthio)‐1H‐Benzimidazole [Pantoprazole‐Sulphide] 1 Kg. 1. 3‐Hydroxy‐2‐Methyl‐4H‐Pyran‐4‐ One[Maltol] 1.32 kg 2. Toluene 4.60 kg 3. Methanol 2.458 kg 4. Methylene dichloride 2.457 kg 5. Acetone 0.35 kg
5‐Difluoromethoxy‐2‐mercapto 1H‐ Benzimidazole 0.70 kg 24
Case No.:24/18/82‐ALC4/2010
Party Name:SALVI CHEMICAL INDUSTRIES LIMITED Meet No/Date:44/82‐ALC4/2010 01.02.2011 Status:Case Deferred HQ File :01/82/050/00567/AM11/ RLA File :03/95/040/00196/AM11/ Lic.No/Date:0310579194 17.06.2010 Defer Date:01.03.2011 25
Case No.:14/26/82‐ALC4/2010
Party Name:DIVIS LABORATORIES LTD., 01.02.2011 Status:Case Approved HQ File :01/82/050/00832/AM11/ RLA File :09/24/040/00088/AM11/ Lic.No/Date:0910042382 17.06.2010 Decision : Commi쏧ee considered case as per agenda and in light of earlier decision taken in 5/82 meeng held on 29.04.2008 and in consultaon with technical authority present in meeng, decided to rafy 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 Levodopa 1 Kg. 1. L‐Tyrosine 2.33 kg 2. Methanol 1.38 kg 26
Case No.:59/22/82‐ALC4/2010
Party Name:EUROMED HEALTH PRIVATE LIMITED 01.02.2011 Status:Case Rejected HQ File :01/82/050/00712/AM11/ RLA File :35/24/040/00018/AM11/ Lic.No/Date:3510030697 21.06.2010 Defer Date: Decision :Commi쏧ee considered case as per agenda and observed that the firm was requested to furnish technical informaon vide le쏧er dated 09.12.2010, but the same has not been received and norms can not be fixed in absence of the required informaon. Accordingly, it was decided to reject the case. 27
Case No.:28/31/82‐ALC4/2010
Party Name:MATRIX LABORATORIES LTD 01.02.2011 Status:Case Deferred HQ File :01/82/050/00953/AM11/ RLA File :09/24/040/00083/AM11/ Lic.No/Date:0910042514 25.06.2010 Defer Date:01.03.2011
28
Case No.:56/22/82‐ALC4/2010
Party Name:AARTI INDUSTRIES LIMITED 01.02.2011 Status:Case Approved HQ File :01/82/050/00709/AM11/ RLA File :03/94/040/00282/AM11/ Lic.No/Date:0310581151 29.06.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M. No.35011/150/2010‐PI (Norms) dated 06.12.2010 and in consultaon with technical authories present in meeng, decided to rafy 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 Benazepril Hcl 1 Kg. 1. (R)‐2‐Hydroxy‐4‐Phenylbutanoic Acid (R)‐2‐Hydroxy‐ 4‐Phenylbutanoic Acid Ethyl Ester 0.762 kg 2. T‐Butyl‐3S‐Amino‐2,3,4,5‐Tetrahydro‐L‐H‐(1)‐ Benazepin‐2‐One‐L‐Acetate 0.8873 kg 29
Case No.:64/22/82‐ALC4/2010
Party Name:GLENMARK GENERICS LIMITED 01.02.2011 Status:Case Approved HQ File :01/82/050/00717/AM11/ RLA File :03/94/040/00287/AM11/ Lic.No/Date:0310581185 29.06.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M. No.35011/142/2010‐PI (Norms) dated 06.12.2010 and in consultaon with technical authority present in meeng decided to rafy 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 Erbumins 1 kg. 1. 2(S)‐Indoline‐2‐Carboxylic acid 0.947kg 2. Methanol 1.43 kg 3. Toluene 3.22 kg 4. Methylene Chloride/Methylene Dichloride/MDC 15.19 kg 5. L‐Norvaline 1.423 kg 6. Acetonitrile 3.57 kg 7. Sodium Pyruvate 1.42 kg 30
Case No.:24/15/82‐ALC4/2010
Party Name:SUVEN LIFE SCIENCES LIMITED Status:Case
01.02.2011 Approved HQ File :01/82/050/00461/AM11/ RLA File :09/24/040/00115/AM11/ Lic.No/Date:0910042551 30.06.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals and in consultaon with technical authority present in meeng, decided to rafy 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 Gabapenn 1 kg 1. Cyclohexane‐1,1‐Diacec Acid monoamide (CDAM) 1.765 kg 2. Acetone 3.50 kg 31
Case No.:32/26/82‐ALC4/2010
Party Name:CIPLA LIMITED 01.02.2011 Status:Case Approved HQ File :01/82/050/00850/AM11/ RLA File :03/94/040/00304/AM11/ Lic.No/Date:0310581968 02.07.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their U.O. No.35011/241/2008‐PI‐III dated 17.03.2009 and in consultaon with technical authority present in meeng decided to rafy 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 Nevirapine 200 mg tablet (Nevirapine = 204 mg/200 mg tablet) 1 No. 1. 3‐(2‐Chloro‐3‐Pyridine‐Carbonyl)‐Amino‐2‐ Chloro‐4‐Methyl Pyridine/NVP(II) Compound 1.428 kg/kg of Nevirapine 2. Cyclopropylamine 0.57 kg/kg of Nevirapine 3. Diglyme 2.76 kg/kg of Nevirapine 4. Calcium Oxide 0.55 kg/kg of Nevirapine Nevirapine Oral Soluon 50 mg/5 ml, 100 ml bo쏧le (Nevirapine = 1020 mg/100 ml bo쏧le) 1 No. 5. Sodium Hydride 0.44 kg/kg of Nevirapine 6. Ethyl Acetate 1.70 kg/kg of Nevirapine 32
Case No.:14/16/82‐ALC4/2010
Party Name:SRINI PHARMACEUTICALS LTD., Status:Case
01.02.2011 Deferred HQ File :01/82/050/00530/AM11/ RLA File :09/24/040/00109/AM11/ Lic.No/Date:0910042643 08.07.2010 Defer Date:01.03.2011 33
Case No.:28/26/82‐ALC4/2010
Party Name:VASUDHA PHARMA CHEM LTD 01.02.2011 Status:Case Deferred HQ File :01/82/050/00846/AM11/ RLA File :09/24/040/00397/AM10/ Lic.No/Date:0910042652 08.07.2010 Defer Date:01.03.2011 34
Case No.:67/39/82‐ALC4/2010
Party Name:KREATIVE ORGANICS (P) LTD., 01.02.2011 Status:Case Approved HQ File :01/82/050/01148/AM11/ RLA File :09/24/040/00067/AM11/ Lic.No/Date:0910042698 16.07.2010 Decision :Withdrawn as the case has already been approved by NC in 43/82 meeng held on 25.02.2011. 35
Case No.:1/18/82‐ALC4/2010
Party Name:SUPER URECOAT INDUSTRIES 01.02.2011 Status:Case Deferred HQ File :01/82/050/00544/AM11/ RLA File :08/24/040/00112/AM11/ Lic.No/Date:0810090597 19.07.2010 Defer Date:01.03.2011 36
Case No.:32/18/82‐ALC4/2010
Party Name:PARABOLIC DRUGS LTD., 01.02.2011 Status:Case Deferred HQ File :01/82/050/00575/AM11/ RLA File :05/24/040/00465/AM10/ Lic.No/Date:0510268627 21.07.2010 Defer Date:29.03.2011 37
Case No.:123/40/82‐ALC4/2010
Party Name:SAURAV CHEMICALS LTD, 01.02.2011 Status:Case Deferred HQ File :01/82/050/01322/AM11/ RLA File :22/24/040/00015/AM11/ Lic.No/Date:2210010200 21.07.2010 Defer Date:01.03.2011
38
Case No.:39/18/82‐ALC4/2010
Party Name:RELIANCE INDUSTRIES LTD. 01.02.2011 Status:Case Deferred HQ File :01/82/050/00582/AM11/ RLA File :03/95/040/00277/AM11/ Lic.No/Date:0310584525 22.07.2010 Defer Date:01.03.2011 Decision :Commi쏧ee considered case as per agenda and observed that certain technical informaon have been called by Department of C&PC from the firm. It was, therefore, decided to call the firm for personal hearing on 01.03.2011 alongwith their reply. Accordingly, case was deferred for 01.03.2011. 39
Case No.:40/18/82‐ALC4/2010
Party Name:RELIANCE INDUSTRIES LTD. 01.02.2011 Status:Case Deferred HQ File :01/82/050/00583/AM11/ RLA File :03/95/040/00278/AM11/ Lic.No/Date:0310584527 22.07.2010 Defer Date:01.03.2011 Decision : Commi쏧ee considered case as per agenda and observed that certain technical informaon have been called by Department of C&PC from the firm. It was, therefore, decided to call the firm for personal hearing on 01.03.2011 alongwith their reply. Accordingly, case was deferred for 01.03.2011. 40
Case No.:19/26/82‐ALC4/2010
Party Name:PRASOL CHEMICALS LIMITED 01.02.2011 Status:Case Approved HQ File :01/82/050/00837/AM11/ RLA File :03/95/040/00156/AM11/ Lic.No/Date:0310584802 23.07.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their 14010/90/2010‐Ch.II dated 08.12.2010 and in consultaon with technical authority present in meeng, decided to rafy 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 Hexylene Glycol 1 Kg. 1. Acetone 1.200 kg 41
Case No.:12/19/82‐ALC4/2010
Party Name:DORF‐KETAL CHEMICALS INDIA PVT.LTD. 01.02.2011 Status:Case Approved HQ File :01/82/050/00597/AM11/ RLA File :03/94/040/00378/AM11/ Lic.No/Date:0310585034 26.07.2010 Decision :withdrawn as the case has already been closed by NC in 43/82 meeng held on 25.01.2011. 42
Case No.:3/28/82‐ALC4/2010
Party Name:FORACE POLYMERS (P) LTD. 01.02.2011 Status:Case Deferred HQ File :01/82/050/00885/AM11/ RLA File :05/23/040/00111/AM11/ Lic.No/Date:0510269207 28.07.2010 Defer Date:29.03.2011 Decision : Commi쏧ee decided to defer case for 29.03.2011 for comments of Department of C&PC.
43
Case No.:61/39/82‐ALC4/2010
Party Name:MEDCHL CHEMICALS AND PHARMACEUTICALS PVT LTD 01.02.2011 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:22.02.2011 Decision : Commi쏧ee decided to defer case for 22.02.2011 for comments of Department of Pharmaceucals. 44
Case No.:6/20/82‐ALC4/2010
Party Name:VASUDHA PHARMA CHEM LTD 01.02.2011 Status:Case Deferred HQ File :01/82/050/00632/AM11/ RLA File :09/24/040/00167/AM11/ Lic.No/Date:0910043026 10.08.2010 Defer Date:01.03.2011 45
Case No.:2/39/82‐ALC4/2010
Party Name:BLUE CIRCLE ORGANICS PVT. LTD. 01.02.2011 Status:Case Deferred HQ File :01/82/050/01083/AM11/ RLA File :03/94/040/00331/AM11/ Lic.No/Date:0310588174 17.08.2010 Defer Date:22.02.2011 Decision : Commi쏧ee decided to defer case for 22.02.2011 for comments of Department of Pharmaceucals. 46
Case No.:44/22/82‐ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 01.02.2011 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:01.03.2011 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments Department of Pharmaceucals and in consultaon with technical authority present in meeng, decided to rafy 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 DR 125 mg tabs. 1 No. 1. Divalproex Sodium USP 134.625 mg 2. Povidone K‐30 USP 9.50 mg 3. Microcrystalline Cellulose NF 52.94 mg 4. Magnesium Stearate NF 2.37 mg 5. Methacrylic Acid Copoly Disperson NF 43.04 mg 6. Triethyl Citrate NF 1.50 mg 7. 950 CC White HDPE Bo쏧le Relevant as per packing policy 8. 500 CC White HDPE Bo쏧le policy
75 CC White HDPE Round Bo쏧le policy 10. NCRC white Cap 53 mm policy 11. CRC White Cap 33 MM policy Divalproex Sodium DR 250 mg tabs. 1 No. 1. Divalproex Sodium USP 269.25 mg 2. Povidone K‐30 USP 19.0 mg 3. Microcrystalline Cellulose NF 105.87 mg 4. Magnesium Stearate NF 4.75 mg 5. Methacrylic Acid Copoly Disperson NF 80.00 mg 6. Triethyl Citrate NF 2.40 mg 7. 950 CC White HDPE Bo쏧le policy 8. 500 CC White HDPE Bo쏧le policy 9. 75 CC White HDPE Round Bo쏧le policy 10. NCRC white Cap 53 mm policy 11. CRC White Cap 33 MM policy Divalproex Sodium DR 500 mg tabs. 1 No. 1. Divalproex Sodium USP 538.5 mg 2. Povidone K‐30 USP 38.0 mg 3. Microcrystalline Cellulose NF 211.75 mg 4. Magnesium Stearate NF 9.50 mg 5. Methacrylic Acid Copoly Disperson NF 160.00 mg 6. Triethyl Citrate NF 4.80 mg 7. 950 CC White HDPE Bo쏧le policy 8. 500 CC White HDPE Bo쏧le policy 9. 75 CC White HDPE Round Bo쏧le policy 10. NCRC white Cap 53 mm policy 11. CRC White Cap 33 MM policy
47
Case No.:101/40/82‐ALC4/2010
Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 01.02.2011 Status:Case Approved HQ File :01/82/050/01300/AM11/ RLA File :31/24/040/00087/AM11/ Lic.No/Date:3110044406 19.08.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/111/2008‐Ch.II dated 02.11.2010 and in consultaon with technical authority present in meeng, decided to rafy 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 2,6 Xylidine 1 kg 1. Phenol 1.770 kg 2. Methanol 1.345 kg 48
Case No.:18/23/82‐ALC4/2010
Party Name:NEULAND LABORATORIES LTD 01.02.2011 Status:Case Deferred HQ File :01/82/050/00786/AM11/ RLA File :09/24/040/00196/AM11/ Lic.No/Date:0910043220 24.08.2010 Defer Date:29.03.2011 49
Case No.:23/23/82‐ALC4/2010
Party Name:DELTA FINOCHEM PVT.LTD. 01.02.2011 Status:Case Deferred HQ File :01/82/050/00791/AM11/ RLA File :03/94/040/00249/AM11/ Lic.No/Date:0310589441 25.08.2010 Defer Date:01.03.2011 50
Case No.:2/24/82‐ALC4/2010
Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. 01.02.2011 Status:Case Approved HQ File :01/82/050/00802/AM11/ RLA File :03/94/040/00488/AM11/ Lic.No/Date:0310590420 31.08.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their O.M. No.46011/89/2010‐PC‐II dated 24.12.2010 and in consultaon with technical authority present in meeng, decided to rafy 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 Aqueous Soluon of 2‐Hydroxy 3‐ Dimethyl amine Chloride Propane 1 kg 1. Epichlorohydrin 0.377 kg 2. Dimethylamine (40%) 0.460 kg
Polymer (Acve Content 55% Minimum) 51
Case No.:82/40/82‐ALC4/2010
Party Name:RATNAGIRI CHEMICALS PVT. LTD. 01.02.2011 Status:Case Approved HQ File :01/82/050/01281/AM11/ RLA File :03/95/040/00410/AM11/ Lic.No/Date:0310590642 01.09.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/97/2006‐Ch.II dated 05.10.2010 and in consultaon with technical authority present in meeng, decided to rafy 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 Hydroquinone Monomethyl Ether (Purity Min.99.5%) 1 kg 1. Hydroquinone 1.11 kg 2. Para Benzoquinone 0.15 kg 52
Case No.:11/24/82‐ALC4/2010
Party Name:ARCH PHARMALABS LTD 01.02.2011 Status:Case Deferred HQ File :01/82/050/00811/AM11/ RLA File :03/94/040/00502/AM11/ Lic.No/Date:0310591355 07.09.2010 Defer Date:01.03.2011 53
Case No.:43/31/82‐ALC4/2010
Party Name:MADHUKAR HORMONES & STERODIS [P] LTD. 01.02.2011 Status:Case Deferred HQ File :01/82/050/00968/AM11/ RLA File :03/95/040/00341/AM11/ Lic.No/Date:0310593360 22.09.2010 Defer Date:01.03.2011 Decision :Commi쏧ee decided to remind the firm to furnish technical details as per Appendix 33. Accordingly, case was deferred for 01.03.2011. 54
Case No.:2/28/82‐ALC4/2010
Party Name:ALEMBIC LIMITED 01.02.2011 Status:Case Approved HQ File :01/82/050/00884/AM11/ RLA File :34/24/040/00112/AM11/ Lic.No/Date:3410028120 28.09.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments Department of Pharmaceucals and in consultaon with technical authority present in meeng, decided to rafy 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 Azithromycin Isopropanolate Monohydrate 1 kg. 1. Acetone 7.285 kg 2. Ethyl Acetate 1.34 kg 3. Isopropyl Alcohol 2.54 kg 4. Hydroxylamine Hydrochloride 1.036 kg 5. Ammonium Thiocyanate 0.088 kg 6. Methanol 3.078 kg 7. Methylene Chloride 3.18 kg 8. Absolute Ethyl Alcohol with DE 1.14 kg 9. Planum Metal 99.95% 0.101 gram 10. Acvated Carbon Qualigens SQ 0.027 kg 55
Case No.:5/28/82‐ALC4/2010
Party Name:ANUS LABORATORIES LTD., 01.02.2011 Status:Case Deferred HQ File :01/82/050/00887/AM11/ RLA File :09/24/040/00137/AM11/ Lic.No/Date:0910043673 28.09.2010 Defer Date:01.03.2011 56
Case No.:7/28/82‐ALC4/2010
Party Name:UNIMARK REMEDIES LIMITED., 01.02.2011 Status:Case Deferred HQ File :01/82/050/00889/AM11/ RLA File :03/95/040/00403/AM11/ Lic.No/Date:0310594441 29.09.2010 Defer Date:29.03.2011 57
Case No.:8/28/82‐ALC4/2010
Party Name:UNIMARK REMEDIES LIMITED., 01.02.2011 Status:Case Deferred HQ File :01/82/050/00890/AM11/ RLA File :03/95/040/00466/AM11/ Lic.No/Date:0310594450 29.09.2010 Defer Date:29.03.2011 58
Case No.:9/28/82‐ALC4/2010
Party Name:SUVEN LIFE SCIENCES LIMITED 01.02.2011 Status:Case Approved HQ File :01/82/050/00891/AM11/ RLA File :09/24/040/00256/AM11/ Lic.No/Date:0910043740 29.09.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M.
No.35011/332/2009‐PI‐(Norms) dated 09.01.2010 and in consultaon with technical authority present in meeng, decided to rafy 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 2‐2‐ Chloromethylphenyl‐3‐ Methoxy‐2‐Acrylate 1 Kg. 1. 3‐Isochromanone 0.957 kg 2. O‐Xylene 1.04 kg 3. Sodium Methoxide Powder 0.416 kg 4. Thionyl Chloride 1.24 kg 5. Methanol 2.31 kg 59
Case No.:10/28/82‐ALC4/2010
Party Name:VIVIMED LABS LIMITED 01.02.2011 Status:Case Deferred HQ File :01/82/050/00892/AM11/ RLA File :09/24/040/00273/AM11/ Lic.No/Date:0910043757 30.09.2010 Defer Date:01.03.2011 60
Case No.:11/28/82‐ALC4/2010
Party Name:S M S PHARMACEUTICALS LTD 01.02.2011 Status:Case Deferred HQ File :01/82/050/00893/AM11/ RLA File :09/24/040/00271/AM11/ Lic.No/Date:0910043759 30.09.2010 Defer Date:29.03.2011 61
Case No.:12/28/82‐ALC4/2010
Party Name:S M S PHARMACEUTICALS LTD 01.02.2011 Status:Case Deferred HQ File :01/82/050/00894/AM11/ RLA File :09/24/040/00278/AM11/ Lic.No/Date:0910043760 30.09.2010 Defer Date:29.03.2011 62
Case No.:14/28/82‐ALC4/2010
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 01.02.2011 Status:Case Deferred HQ File :01/82/050/00896/AM11/ RLA File :09/24/040/00272/AM11/ Lic.No/Date:0910043780 01.10.2010 Defer Date:29.03.2011 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M. No.35011/217/2009‐PI‐(Norms) dated 01.02.2010, decided to call for the following informaon from the firm.
1. Complete chemical reacon indicang molar weight of each import of output material and % yield on molar basis. 2. Material balance for the enre process. 3. Requirement and recovery of solvents at each step of manufacturing process. Accordingly, case was deferred for 29.03.2011. 63
Case No.:17/28/82‐ALC4/2010
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 01.02.2011 Status:Case Approved HQ File :01/82/050/00899/AM11/ RLA File :07/24/040/00257/AM11/ Lic.No/Date:0710074553 01.10.2010 Decision : Commi쏧ee considered case as per agenda and in consultaon with technical authority present in meeng, decided to rafy 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 Co‐Amoxiclav Injecon BP 600 mg Verclav 600 mg Vial Size 7.5 ml Each Vial contains: Clavulonic Acid 100 mg As Sterile Clavulanate Potassium BP equivalent to Amoxycillin 500 mg As Sterile Amoxycillin Sodium BP 1Vial 1. Sterile Clavulanate Potassium BP with Sterile Amoxicillin Sodium BP Mixture (1:5) 612 mg 64
Case No.:20/28/82‐ALC4/2010
Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. 01.02.2011 Status:Case Deferred HQ File :01/82/050/00902/AM11/ RLA File :03/94/040/00567/AM11/ Lic.No/Date:0310594816 01.10.2010 Defer Date:01.03.2011 65
Case No.:25/28/82‐ALC4/2010
Party Name:BLISS GVS PHARMA LTD. 01.02.2011 Status:Case Deferred HQ File :01/82/050/00907/AM11/ RLA File :03/94/040/00593/AM11/ Lic.No/Date:0310594844 01.10.2010 Defer Date:29.03.2011 66
Case No.:18/28/82‐ALC4/2010
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 01.02.2011 Status:Case Approved HQ File :01/82/050/00900/AM11/ RLA File :07/24/040/00263/AM11/ Lic.No/Date:0710074559
04.10.2010 Decision : Commi쏧ee considered case as per agenda and in consultaon with technical authority present in meeng, decided to rafy 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 Ce챦azidime for Injecon USP 1 gm Vial Size:20 ml 1Vial 1. Ce챦azimide USP (As Ce챦azidime Pentahydrate) (As Blend of Sterile Ce챦azidime Pentahydrate & Sterile Sodium Carbonate) USP 1.13 gram 67
Case No.:21/28/82‐ALC4/2010
Party Name:PRAVEEN LABORATORIES PVT LTD, 01.02.2011 Status:Case Deferred HQ File :01/82/050/00903/AM11/ RLA File :52/24/040/00021/AM11/ Lic.No/Date:5210032090 04.10.2010 Defer Date:29.03.2011 68
Case No.:24/28/82‐ALC4/2010
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 01.02.2011 Status:Case Deferred HQ File :01/82/050/00906/AM11/ RLA File :07/24/040/00264/AM11/ Lic.No/Date:0710074577 04.10.2010 Defer Date:29.03.2011 Decision :Commi쏧ee considered case as per agenda and observed that the Drug Manufactured Licence furnished by the firm alongwith their applicaon is not for Kanamycin Acid Sulphate for Injecon BP 1 gm. It was, therefore, decided to call for the relevant DML from the firm. Accordingly, case was deferred for 29.03.2011. 69
Case No.:3/31/82‐ALC4/2010
Party Name:EMAMI LIMITED, 01.02.2011 Status:Case Deferred HQ File :01/82/050/00928/AM11/ RLA File :02/24/040/00119/AM11/ Lic.No/Date:0210149202 12.10.2010 Defer Date:29.03.2011 Decision :Commi쏧ee decided to forward a copy of applicaon to Department of Pharmaceucals for their comments. Accordingly, case was deferred for 29.03.2011. 70
Case No.:13/31/82‐ALC4/2010
Party Name:SRINI PHARMACEUTICALS LTD., 01.02.2011 Status:Case Approved HQ File :01/82/050/00938/AM11/ RLA File :09/24/040/00303/AM11/ Lic.No/Date:0910043939 15.10.2010 Decision : Commi쏧ee considered case as per agenda and in light wri쏧en comments of Department of Pharmaceucals and in consultaon with technical authority
present in meeng, decided to rafy 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 Levofloxacin Hemihydrate 1 kg 1. 9,10‐Difluoro‐2,3‐dihydro‐3‐methyl‐7‐ oxo‐(3S)‐7H‐pyrido[1,2,3‐de]‐1,4‐ benzoxazine‐6‐carboxylic Acid (LVF40) 1.01 kg 2. Hexamethyl disiloxane (HMDS) 0.582 kg 3. N‐Methylpiperazine 0.432 kg 71
Case No.:124/40/82‐ALC4/2010
Party Name:SURYA PHARMACEUTICAL LTD 01.02.2011 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:01.03.2011 Decision :Commi쏧ee decided to defer case for 01.03.2011 for comments of Department of Pharmaceucals. 72
Case No.:47/31/82‐ALC4/2010
Party Name:SUPREET CHEMICALS PVT.LTD. 01.02.2011 Status:Case Approved HQ File :01/82/050/00972/AM11/ RLA File :03/95/040/00554/AM11/ Lic.No/Date:0310597803 20.10.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/42/2005‐Ch.II dated 01.02.2011 and in consultaon with technical authories present in meeng, decided to rafy 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 4‐Methyl‐3‐Nitro Phenyl Methyl Sulfone (NMST or 4‐NT Acid) 1 Kg. 1. Para Toluene Sulfonylchloride (PTSC) 2.087 kg 73
Case No.:57/40/82‐ALC4/2010
Party Name:MATRIX LABORATORIES LTD 01.02.2011 Status:Case Deferred HQ File :01/82/050/01256/AM11/ RLA File :09/24/040/00237/AM11/ Lic.No/Date:0910043987 20.10.2010 Defer Date:01.03.2011 74
Case No.:57/31/82‐ALC4/2010
Party Name:VIVIMED LABS LIMITED 01.02.2011 Status:Case
Deferred HQ File :01/82/050/00982/AM11/ RLA File :09/24/040/00296/AM11/ Lic.No/Date:0910044017 22.10.2010 Defer Date:01.03.2011 75
Case No.:63/40/82‐ALC4/2010
Party Name:EMAMI LIMITED, 01.02.2011 Status:Case Deferred HQ File :01/82/050/01262/AM11/ RLA File :02/24/040/00120/AM11/ Lic.No/Date:0210149565 25.10.2010 Defer Date:29.03.2011 Decision :Commi쏧ee decided to forward a copy of applicaon to Department of Pharmaceucals for their comments. Accordingly, case was deferred for 29.03.2011. 76
Case No.:7/32/82‐ALC4/2010
Party Name:ARCH PHARMALABS LTD 01.02.2011 Status:Case Deferred HQ File :01/82/050/00989/AM11/ RLA File :03/94/040/00657/AM11/ Lic.No/Date:0310599277 28.10.2010 Defer Date:01.03.2011 77
Case No.:87/40/82‐ALC4/2010
Party Name:SYMBIOTEC PHARMALAB LTD., 01.02.2011 Status:Case Approved HQ File :01/82/050/01286/AM11/ RLA File :11/24/040/00033/AM11/ Lic.No/Date:1110023536 15.11.2010 Decision : Commi쏧ee considered case as per agenda and in consultaon with technical authories present in meeng, decided to rafy 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 Beclomethasone Dipropionate IP/BP/EP/USP 1 Kg. 1. 17 Alpha 21‐Dihydroxy‐16‐Beta Methyl‐9‐Beta‐Epoxy‐Pregna‐1,4‐ Diene‐3,20‐Dione (DB‐XI) 0.95 kg 78
Case No.:3/40/82‐ALC4/2010
Party Name:PADMINI AROMATICS PVT. LTD 01.02.2011 Status:Case Deferred HQ File :01/82/050/01202/AM11/ RLA File :07/24/040/00316/AM11/ Lic.No/Date:0710075478 18.11.2010 Defer Date:01.03.2011 79
Case No.:5/36/82‐ALC4/2010
Party Name:JUBILANT LIFE SCIENCES LIMITED Status:Case
(FORMERLY JUBILANT 01.02.2011 Deferred HQ File :01/82/050/01043/AM11/ RLA File :05/23/040/00219/AM11/ Lic.No/Date:0510277735 24.11.2010 Defer Date:01.03.2011 80
Case No.:6/36/82‐ALC4/2010
Party Name:GALPHA LABORATORIES LIMITED, 01.02.2011 Status:Case Deferred HQ File :01/82/050/01044/AM11/ RLA File :03/94/040/00747/AM11/ Lic.No/Date:0310602797 24.11.2010 Defer Date:29.03.2011 81
Case No.:7/36/82‐ALC4/2010
Party Name:ALKALOIDS CORPORATION 01.02.2011 Status:Case Approved HQ File :01/82/050/01045/AM11/ RLA File :02/24/040/00152/AM11/ Lic.No/Date:0210151006 24.11.2010 Decision : Commi쏧ee considered case as per agenda and in light of its earlier decision taken in its 41/82 meeng held on 11.01.2011 and in consultaon with technical authority present in meeng decided to rafy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Quanty Sl.No. Import items Total Quanty Digoxin Powder BP/USP 1 Kg. 1. Digitalis Lanata Leaves 444.4 kg 82
Case No.:8/36/82‐ALC4/2010
Party Name:ALKALOIDS CORPORATION 01.02.2011 Status:Case Deferred HQ File :01/82/050/01046/AM11/ RLA File :02/24/040/00149/AM11/ Lic.No/Date:0210151007 24.11.2010 Defer Date:01.03.2011 83
Case No.:59/40/82‐ALC4/2010
Party Name:MEDCHL CHEMICALS AND PHARMACEUTICALS PVT LTD 01.02.2011 Status:Case Deferred HQ File :01/82/050/01258/AM11/ RLA File :09/24/040/00324/AM11/ Lic.No/Date:0910044428 24.11.2010 Defer Date:01.03.2011 84
Case No.:9/36/82‐ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED Status:Case
01.02.2011 Deferred HQ File :01/82/050/01047/AM11/ RLA File :09/24/040/00311/AM11/ Lic.No/Date:0910044459 25.11.2010 Defer Date:01.03.2011 85
Case No.:22/40/82‐ALC4/2010
Party Name:HETERO LABS LIMITED 01.02.2011 Status:Case Deferred HQ File :01/82/050/01221/AM11/ RLA File :09/24/040/00358/AM11/ Lic.No/Date:0910044449 25.11.2010 Defer Date:01.03.2011 86
Case No.:25/40/82‐ALC4/2010
Party Name:MATRIX LABORATORIES LTD 01.02.2011 Status:Case Deferred HQ File :01/82/050/01224/AM11/ RLA File :09/24/040/00238/AM11/ Lic.No/Date:0910044429 25.11.2010 Defer Date:01.03.2011 87
Case No.:79/40/82‐ALC4/2010
Party Name:SUPREET CHEMICALS PVT.LTD. 01.02.2011 Status:Case Approved HQ File :01/82/050/01278/AM11/ RLA File :03/95/040/00696/AM11/ Lic.No/Date:0310603141 26.11.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/106/2010‐Ch.II dated 01.02.2011 and in consultaon with technical authories present in meeng, decided to rafy 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 Acid Blue 277 (ABR Acid or SP‐92 or Acid Blue‐RR) 1 Kg. 1. Bromamine Acid 1.160 kg 2. 3,4‐Dimethyl Nitro Benzene (4 NOX or 3,4‐Nitro Xylene) 0.340 kg 88
Case No.:30/40/82‐ALC4/2010
Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 01.02.2011 Status:Case Approved HQ File :01/82/050/01229/AM11/ RLA File :03/94/040/00611/AM11/ Lic.No/Date:0310604615 06.12.2010 Decision :Withdrawn as the case has already been approved by NC in 40/82 meeng held on 04.01.2011.
89
Case No.:11/44/82‐ALC4/2010
Party Name:PARABOLIC DRUGS LTD., 01.02.2011 Status:Case Approved HQ File :01/82/050/01510/AM11/ RLA File :05/24/040/00260/AM11/ Lic.No/Date:0510278891 08.12.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M. No.35011/205/2009‐PI‐(Norms) dated 20.01.2010 and in consultaon with technical authority present in meeng, decided to rafy 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 Ce챦riaxone Sodium Sterile 1 Kg. 1. Ce챦riaxone Sodium (Non Sterile) 1.04 kg 2. Acetone 1.72 kg 3. Eno Carbon 51.66 gm 90
Case No.:10/44/82‐ALC4/2010
Party Name:TRIGON CHEMICALS PVT. LTD. 01.02.2011 Status:Case Deferred HQ File :01/82/050/01509/AM11/ RLA File :31/24/040/00178/AM11/ Lic.No/Date:3110045863 13.12.2010 Defer Date:01.03.2011 91
Case No.:12/44/82‐ALC4/2010
Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. 01.02.2011 Status:Case Deferred HQ File :01/82/050/01511/AM11/ RLA File :31/24/040/00133/AM11/ Lic.No/Date:3110045861 13.12.2010 Defer Date:01.03.2011 92
Case No.:37/44/82‐ALC4/2010
Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. 01.02.2011 Status:Case Deferred HQ File :01/82/050/01536/AM11/ RLA File :31/24/040/00187/AM11/ Lic.No/Date:3110045874 13.12.2010 Defer Date:01.03.2011 93
Case No.:73/40/82‐ALC4/2010
Party Name:ESTEEM INDUSTRIES PVT. LTD, 01.02.2011 Status:Case Deferred HQ File :01/82/050/01272/AM11/ RLA File :17/24/040/00086/AM09/ Lic.No/Date:1710003611 Defer
14.12.2010 Date:01.03.2011 94
Case No.:7/40/82‐ALC4/2010
Party Name:SUVEN LIFE SCIENCES LIMITED 01.02.2011 Status:Case Deferred HQ File :01/82/050/01206/AM11/ RLA File :09/24/040/00414/AM11/ Lic.No/Date:0910044683 15.12.2010 Defer Date:01.03.2011 95
Case No.:8/40/82‐ALC4/2010
Party Name:RA CHEM PHARMA LIMITED 01.02.2011 Status:Case Deferred HQ File :01/82/050/01207/AM11/ RLA File :09/24/040/00413/AM11/ Lic.No/Date:0910044684 15.12.2010 Defer Date:29.03.2011 96
Case No.:11/40/82‐ALC4/2010
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 01.02.2011 Status:Case Deferred HQ File :01/82/050/01210/AM11/ RLA File :05/23/040/00250/AM11/ Lic.No/Date:0510279466 15.12.2010 Defer Date:01.03.2011 Decision :Commi쏧ee decided to remind the firm to furnish copy of DML and Master Batch Formula. Accordingly, case was deferred for 01.03.2011. 97
Case No.:74/40/82‐ALC4/2010
Party Name:ESTEEM INDUSTRIES PVT. LTD, 01.02.2011 Status:Case Deferred HQ File :01/82/050/01273/AM11/ RLA File :17/24/040/00165/AM08/ Lic.No/Date:1710003615 15.12.2010 Defer Date:01.03.2011 98
Case No.:75/40/82‐ALC4/2010
Party Name:ESTEEM INDUSTRIES PVT. LTD, 01.02.2011 Status:Case Deferred HQ File :01/82/050/01274/AM11/ RLA File :17/24/040/00045/AM09/ Lic.No/Date:1710003616 16.12.2010 Defer Date:01.03.2011 99
Case No.:66/40/82‐ALC4/2010
Party Name:STERLING AUXILIARIES PVT LTD 01.02.2011 Status:Case Approved
HQ File :01/82/050/01265/AM11/ RLA File :03/95/040/00287/AM11/ Lic.No/Date:0310606895 20.12.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/93/2007‐Ch.II dated 05.05.2010 and U.O. No.14010/10/2010‐Ch.II dated 24.11.2010 and in consultaon with technical authority present in meeng, decided to rafy 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 Stero DIPA 90 (Diisopropanolamine) 1 Kg. 1. Propylene Oxide 0.870 kg STERO NC 090 (Nonyl Phenol Polyglycol Ether) (Nonyl Phenol 7 mole Ethoxylated) 1 kg. 1. Nonyl Phenol 0.425 kg 2. Ethylene Oxide 0.127 kg 100
Case No.:76/40/82‐ALC4/2010
Party Name:ESTEEM INDUSTRIES PVT. LTD, 01.02.2011 Status:Case Deferred HQ File :01/82/050/01275/AM11/ RLA File :17/24/040/00033/AM10/ Lic.No/Date:1710003624 20.12.2010 Defer Date:01.03.2011 101
Case No.:142/40/82‐ALC4/2010
Party Name:ESTEEM INDUSTRIES PVT. LTD, 01.02.2011 Status:Case Deferred HQ File :01/82/050/01341/AM11/ RLA File :17/24/040/00167/AM08/ Lic.No/Date:1710003626 21.12.2010 Defer Date:01.03.2011 102
Case No.:143/40/82‐ALC4/2010
Party Name:ESTEEM INDUSTRIES PVT. LTD, 01.02.2011 Status:Case Deferred HQ File :01/82/050/01342/AM11/ RLA File :17/24/040/00153/AM08/ Lic.No/Date:1710003627 21.12.2010 Defer Date:01.03.2011 103
Case No.:28/44/82‐ALC4/2010
Party Name:SAVLA CHEMICALS LIMITED 01.02.2011 Status:Case Deferred HQ File :01/82/050/01527/AM11/ RLA File :03/95/040/00633/AM11/ Lic.No/Date:0310607359 22.12.2010 Defer Date:29.03.2011 Decision :Commi쏧ee considered case as per agenda and in light of wri쏧en comments of Department of C&PC, decided to call for the following informaon from the
firm:‐ 1. Purity of import item. 2. Purity of export product. 3. Jusficaon for export. Accordingly, case was deferred for 29.03.2011. 104
Case No.:32/44/82‐ALC4/2010
Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. 01.02.2011 Status:Case Deferred HQ File :01/82/050/01531/AM11/ RLA File :31/24/040/00188/AM11/ Lic.No/Date:3110046108 23.12.2010 Defer Date:01.03.2011 105
Case No.:23/44/82‐ALC4/2010
Party Name:CENTURY PHARMACEUTICALS LTD. 01.02.2011 Status:Case Deferred HQ File :01/82/050/01522/AM11/ RLA File :34/24/040/00240/AM11/ Lic.No/Date:3410028935 27.12.2010 Defer Date:29.03.2011 106
Case No.:29/44/82‐ALC4/2010
Party Name:UNICURE REMEDIES PVT. LTD. 01.02.2011 Status:Case Deferred HQ File :01/82/050/01528/AM11/ RLA File :34/24/040/00234/AM11/ Lic.No/Date:3410028934 27.12.2010 Defer Date:29.03.2011 107
Case No.:16/44/82‐ALC4/2010
Party Name:GLENMARK GENERICS LIMITED 01.02.2011 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:01.03.2011 108
Case No.:27/44/82‐ALC4/2010
Party Name:SARAF CHEMICALS LTD. 01.02.2011 Status:Case Deferred HQ File :01/82/050/01526/AM11/ RLA File :03/95/040/00788/AM11/ Lic.No/Date:0310608152 28.12.2010 Defer Date:01.03.2011
p 109
Case No.:26/44/82‐ALC4/2010
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 01.02.2011 Status:Case Approved HQ File :01/82/050/01525/AM11/ RLA File :03/94/040/00840/AM11/ Lic.No/Date:0310608725 30.12.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O.No.14010/9/2005‐Ch.II dated 04.09.2006 and in consultaon with technical authority present in meeng, decided to rafy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export Product Export Qty. Sl.No. Import items Qty. allowed Astrolide (S) (Astrolide content : 100%) 1 kg 1. Alpha Methyl Styrene 0.769 kg 2. Isoamylene 0.584 kg 3. Propylene Oxide 0.430 kg 4. Para Formaldehyde 0.135 kg 110
Case No.:31/44/82‐ALC4/2010
Party Name:MELZER CHEMICALS PVT. LTD 01.02.2011 Status:Case Approved HQ File :01/82/050/01530/AM11/ RLA File :31/24/040/00215/AM11/ Lic.No/Date:3110046238 31.12.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O.No.14010/139/2005‐Ch.II dated 09.08.2007 and in consultaon with technical authority present in meeng, decided to rafy 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 Santreat MZ 3060 Dimethyl Lauryl Benzyl Ammonium Chloride 60% 1 kg 1. Dimethyl Lauryl Amine 0.385 kg 111
Case No.:21/44/82‐ALC4/2010
Party Name:BEST VALUE CHEM PVT. LTD. 01.02.2011 Status:Case Approved HQ File :01/82/050/01520/AM11/ RLA File :34/24/040/00260/AM11/ Lic.No/Date:3410029013 03.01.2011 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/112/2005/Ch.II dated 03.01.2011 and in consultaon with technical authority present in meeng, decided to rafy 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 Amyl Salicylate 1 Kg. 1. Primary Amyl Alcohol 0.470 kg 2. Salicylic Acid 0.737 kg 112
Case No.:22/44/82‐ALC4/2010
Party Name:BEST VALUE CHEM PVT. LTD. 01.02.2011 Status:Case Approved HQ File :01/82/050/01521/AM11/ RLA File :34/24/040/00258/AM11/ Lic.No/Date:3410029012 03.01.2011 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/112/2005/Ch.II dated 03.01.2011 and in consultaon with technical authority present in meeng, decided to rafy 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 Amyl Salicylate 1 Kg. 1. Primary Amyl Alcohol 0.470 kg 2. Salicylic Acid 0.737 kg 113
Case No.:25/44/82‐ALC4/2010
Party Name:MAHAVIR INTERMEDIATES 01.02.2011 Status:Case Deferred HQ File :01/82/050/01524/AM11/ RLA File :52/24/040/00028/AM11/ Lic.No/Date:5210033299 05.01.2011 Defer Date:01.03.2011 114
Case No.:15/44/82‐ALC4/2010
Party Name:BLISS GVS PHARMA LTD. 01.02.2011 Status:Case Deferred HQ File :01/82/050/01514/AM11/ RLA File :03/94/040/00887/AM11/ Lic.No/Date:0310609857 06.01.2011 Defer Date:01.03.2011 115
Case No.:14/44/82‐ALC4/2010
Party Name:CIPLA LIMITED 01.02.2011 Status:Case Deferred HQ File :01/82/050/01513/AM11/ RLA File :03/94/040/00892/AM11/ Lic.No/Date:0310610020 07.01.2011 Defer Date:01.03.2011
116
Case No.:24/44/82‐ALC4/2010
Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED 01.02.2011 Status:Case Approved HQ File :01/82/050/01523/AM11/ RLA File :52/24/040/00042/AM11/ Lic.No/Date:5210033337 07.01.2011 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/ /2008/Ch.II dated 13.07.2010 and in consultaon with technical authority present in meeng, decided to rafy 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 4‐(2‐Chloro Ethylsulfonyl) Butyric Acid (XAZ Base) 1 Kg. 1. Gamma Butyrolactone 0.665 kg 2. 2‐Mercapto Ethanol 0.691 kg 117
Case No.:13/44/82‐ALC4/2010
Party Name:WEXFORD LABORATORIES P LTD 01.02.2011 Status:Case Approved HQ File :01/82/050/01512/AM11/ RLA File :07/24/040/00407/AM11/ Lic.No/Date:0710076670 11.01.2011 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M. 35011/237/2009‐ PI‐(Norms) dated 27.01.2010 and in consultaon with technical authority present in meeng decided to rafy 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 Ce챦riaxone for Injecon 1 gm vial 1 Vial 1. Ce챦riaxone Sodium Sterile USP 1.113 gm/vial 118
Case No.:17/44/82‐ALC4/2010
Party Name:ENALTEC LABS PVT.LTD. 01.02.2011 Status:Case Deferred HQ File :01/82/050/01516/AM11/ RLA File :03/94/040/00867/AM11/ Lic.No/Date:0310610417 11.01.2011 Defer Date:29.03.2011 119
Case No.:18/44/82‐ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 01.02.2011 Status:Case Approved
HQ File :01/82/050/01517/AM11/ RLA File :08/24/040/00305/AM11/ Lic.No/Date:0810095479 12.01.2011 Decision : Commi쏧ee considered case as per agenda and in light of earlier decision taken in 6/82 meeng held on 06.05.2008 and in consultaon with technical authority present in meeng, decided to rafy 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 Me娷�ormin Tablets 850 mg 1 million 1. Me娷�ormin Hcl 867.0 kg 2. Povidone K 30 58.641 kg 3. Microcrystalline Cellulose 45.90 kg 4. Magnesium Stearate 3.315 kg 5. Hypermellose 40.715 kg 6 to 12 Bo쏧les & Caps As per packing policy 120
Case No.:19/44/82‐ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 01.02.2011 Status:Case Approved HQ File :01/82/050/01518/AM11/ RLA File :08/24/040/00304/AM11/ Lic.No/Date:0810095478 12.01.2011 Decision : Commi쏧ee considered case as per agenda and in light of earlier decision taken in 50/10 meeng held on 09.03.2010 and in consultaon with technical authority present in meeng, decided to rafy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower on repeat basis as per NC decision taken on 06.05.2008:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Me娷�ormin tablets 1000 mg 1 Million 1. Me娷�ormin Hcl 1020.00 kg 2. Povidone K 30 69.00 kg 3. Microcrystalline Cellulose 54.00 kg 4. Magnesium Stearate 3.90 kg 5. Hypermellose 79.90 kg 6. Bo쏧les and Caps As per packing policy 121
Case No.:20/44/82‐ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 01.02.2011 Status:Case Approved HQ File :01/82/050/01519/AM11/ RLA File :08/24/040/00303/AM11/ Lic.No/Date:0810095477 12.01.2011 Decision : Commi쏧ee considered case as per agenda and in light of earlier decision taken in 32/82 meeng held on 03.11.2009 and in consultaon with technical authority present in meeng, decided to rafy 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 Me娷�ormin tablets 500 mg 1 Million 1. Me娷�ormin Hcl 510.00 kg 2. Povidone K 30 34.50 kg 3. Microcrystalline Cellulose 27.00 kg 4. Magnesium Stearate 1.95 kg 5. Hypermellose 23.95 kg 6. Bo쏧les and Caps As per packing policy 122
Case No.:33/44/82‐ALC4/2010
Party Name:CLARION DRUGS LTD., 01.02.2011 Status:Case Deferred HQ File :01/82/050/01532/AM11/ RLA File :50/24/040/00023/AM11/ Lic.No/Date:5010000500 13.01.2011 Defer Date:01.03.2011 123
Case No.:1/44/82‐ALC4/2010
Party Name:VISEN INDUSTRIES LIMITED 01.02.2011 Status:Case Deferred HQ File :01/82/050/01500/AM11/ RLA File :03/95/040/00749/AM11/ Lic.No/Date:0310611695 19.01.2011 Defer Date:01.03.2011 Decision : Commi쏧ee decided to defer case for 01.03.2011 for comments of Department of C&PC, PC Division. 124
Case No.:2/44/82‐ALC4/2010
Party Name:ARCH PHARMALABS LTD 01.02.2011 Status:Case Deferred HQ File :01/82/050/01501/AM11/ RLA File :03/94/040/00901/AM11/ Lic.No/Date:0310611746 19.01.2011 Defer Date:01.03.2011 125
Case No.:3/44/82‐ALC4/2010
Party Name:STERLING AUXILIARIES PVT LTD 01.02.2011 Status:Case Deferred HQ File :01/82/050/01502/AM11/ RLA File :03/95/040/00797/AM11/ Lic.No/Date:0310611792 19.01.2011 Defer Date:01.03.2011 126
Case No.:4/44/82‐ALC4/2010
Party Name:VIJAYASRI ORGANICS LTD 01.02.2011 Status:Case Deferred
HQ File :01/82/050/01503/AM11/ RLA File :09/71/040/00083/AM11/ Lic.No/Date:0910045205 19.01.2011 Defer Date:29.03.2011 127
Case No.:5/44/82‐ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 01.02.2011 Status:Case Deferred HQ File :01/82/050/01504/AM11/ RLA File :05/24/040/00342/AM11/ Lic.No/Date:0510281982 19.01.2011 Defer Date:29.03.2011 128
Case No.:6/44/82‐ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 01.02.2011 Status:Case Approved HQ File :01/82/050/01505/AM11/ RLA File :09/24/040/00460/AM11/ Lic.No/Date:0910045213 20.01.2011 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M. No.35011/279/2009‐PI‐III dated 28.04.2010 and in consultaon with technical authority present in meeng, decided to rafy 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 Gabapenn 1 Kg. 1. 1,1‐Cyclohexane Diacec Acid 1.941 kg 2. Acetone 1.35 kg 3. Carbon Enoancromos (Acvated Carbon) 0.0143 kg 4. Iso propyl Alcohol 1.84 kg 5. Methanol 0.31 kg 129
Case No.:7/44/82‐ALC4/2010
Party Name:SAIRAM ORGANICS PVT. LTD., 01.02.2011 Status:Case Deferred HQ File :01/82/050/01506/AM11/ RLA File :09/24/040/00488/AM11/ Lic.No/Date:0910045214 20.01.2011 Defer Date:29.03.2011 130
Case No.:8/44/82‐ALC4/2010
Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED 01.02.2011 Status:Case Deferred HQ File :01/82/050/01507/AM11/ RLA File :03/94/040/00811/AM11/ Lic.No/Date:0310612024 20.01.2011 Defer Date:29.03.2011
131
Case No.:9/44/82‐ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 01.02.2011 Status:Case Approved HQ File :01/82/050/01508/AM11/ RLA File :05/24/040/00344/AM11/ Lic.No/Date:0510282089 21.01.2011 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their U.O. No.35011/19/2009‐PI‐III dated 01.06.2009 and in consultaon with technical authority present in meeng, decided to rafy 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 Simvastan Bulk Drug/Pharmaceucal Grade) 1 Kg. 1. Acetone 1.042 kg 2. Acvated Carbon 0.035 kg 3. Causc Soda Flakes 0.484 kg 4. Cylohexane 1.33 kg 5. Cyclopropylamine 1.23 kg 6. Ethyl Acetate 4.49 kg 7. Iodine 0.5917 kg 8. Lovastan 1.648 kg 9. Methanol 19.82 kg 10. N‐Butyl Lithium (30% in Hexane) 2.382 kg 11. Pyrrolidine 1.53 kg 12. Tetrahydrofuran 6.58 kg 132
Case No.:30/44/82‐ALC4/2010
Party Name:KUMAR ORGANIC PRODUCTS LIMITED, 01.02.2011 Status:Case Approved HQ File :01/82/050/01529/AM11/ RLA File :07/24/040/00408/AM11/ Lic.No/Date:0710076883 24.01.2011 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/62/2009/Ch.II dated 20.07.2010 and in consultaon with technical authority present in meeng, decided to rafy 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 Zinc Pyrithione (Assay 48‐50%) 1 Kg. 1. 2 Chloro Pyridine (Assay 85%) 0.600 kg
133
Case No.:38/44/82‐ALC4/2010
Party Name:BALAJI AMINES LIMITED 01.02.2011 Status:Case Approved HQ File :01/82/050/01537/AM11/ RLA File :31/24/040/00184/AM11/ Lic.No/Date:3110046570 24.01.2011 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/68/2006‐Ch.II dated 10.05.2010 and in consultaon with technical authories present in meeng, decided to rafy 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 Morpholine 1 Kg. 1. Diethylene Glycol 1.354 kg 2. Ammonia Anhydrous 0.217 kg The firm has not given the details of Catalyst and hence not allowed. Further, Hydrogen is not a importable commodity and therefore not allowed. 134
Case No.:35/44/82‐ALC4/2010
Party Name:VASUDHA PHARMA CHEM LTD 01.02.2011 Status:Case Deferred HQ File :01/82/050/01534/AM11/ RLA File :09/24/040/00421/AM11/ Lic.No/Date:0910045225 25.01.2011 Defer Date:01.03.2011 135
Case No.:36/44/82‐ALC4/2010
Party Name:VASANT CHEMICALS PRIVATE LIMITED Meet No/Date:44/82‐ALC4/2010 01.02.2011 Status:Case Deferred HQ File :01/82/050/01535/AM11/ RLA File :09/24/040/00480/AM11/ Lic.No/Date:0910045226 25.01.2011 Defer Date:01.03.2011 136
Case No.:39/44/82‐ALC4/2010
Party Name:PERKIN LABORATORIES 01.02.2011 Status:Case Deferred HQ File :01/82/050/01538/AM11/ RLA File :09/24/040/00415/AM10/ Lic.No/Date:0910045227 25.01.2011 Defer Date:29.03.2011 137
Case No.:40/44/82‐ALC4/2010
Party Name:PERKIN LABORATORIES 01.02.2011 Status:Case Deferred HQ File :01/82/050/01539/AM11/ RLA File :09/24/040/00459/AM10/ Lic.No/Date:0910045228 25.01.2011 Defer Date:29.03.2011
138
Case No.:41/44/82‐ALC4/2010
Party Name:AUROLAB 01.02.2011 Status:Case Deferred HQ File :01/82/050/01540/AM11/ RLA File :35/24/040/00035/AM11/ Lic.No/Date:3510032550 25.01.2011 Defer Date:29.03.2011
Case No. Outside Agenda‐1
M/s Global Calcium P. Ltd. F.No.01/82/050/00485/AM08/DES‐III RLA F. No. 07/24/040/00725/AM08 Adv. Lic. No.0710055635 dated 29.01.2008 Commi쏧ee considered case and in consultaon with technical authority present in meeng, decided to amend the descripon of import item to read as “Calcium Gluconate Granuler” without any other change in the decision taken in 37/11 held on 14.12.2010.
Case No. Outside Agenda‐2
M/s Srini Pharmaceucals Ltd. F.No.01/87/050/00237/AM06/DES‐III RLA F. No. 09/24/040/00068/AM06 Adv. Lic. No.0910023041 dated 02.06.2005 Commi쏧ee considered case and in consultaon with technical authority present in meeng, decided to amend the descripon of export product to read as “Trans‐3‐(Methanesulfonyloxy Methyl)‐4‐(4‐Fluorophenyl)‐1‐ Methyl Piperidine (PX‐2)” without any other change in the decision taken in 16/87 meeng held on 27.07.2005.
Case No. Outside Agenda‐3
M/s Srini Pharmaceucals Ltd. F.No.01/83/050/00720/AM07/DES‐III RLA F. No. 09/24/040/00253/AM07 Adv. Lic. No.0910027673 dated 26.09.2006 Commi쏧ee considered case as per agenda and in light of earlier decision taken in 9/08 meeng held on 03.07.2007 and in consultaon with technical authories present in meeng, decided to revise 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 Trans‐3‐(Methanesulfonyloxy Methyl)‐4‐Fluorophenyl)‐1‐ Methyl Piperidine(Px2) 1 Kg. 1. (‐)‐trans‐4‐(4‐fluoro phenyl)‐ 3‐hydroxy methyl‐N‐Methyl piperidine 1.016 kg
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