DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi ‐0 ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
Para 4.7 Decision(DRAFT)
MEETING NUMBER : 46/82‐ALC4/2010 MEETING DATE : 15.02.2011 The MeeƟng No.46/82 in the year 2010‐11 to consider the cases under Duty ExempƟon Scheme (Chapter‐4) of Foreign Trade Policy, 2009‐14 pertaining to products falling in Chapter 29 and 30 was held on 15.02.2011 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 Shaish Kumar, IA, DIPP 3. Shri D.N. Mathur, Dy.I.A, Department of PharmaceuƟcals 4. Shri Krishan Kumar, Dy. DGFT 5. Shri Shyam Lal, FTDO At the outset, minutes of Norms CommiƩee MeeƟng No.44/82 dated 01.02.2011 and 45/82 dated 08.02.2011 were raƟfied by the CommiƩee.
Case No. A‐49
M/s Watson Pharma Pvt. Ltd. N C MeeƟng No. 46/11 F.No.01/82/162/00773/AM11/DES‐III MeeƟng Date 15.02.2011 CommiƩee considered case as per agenda and in consultaƟon with technical authority present in meeƟng, decided to call for the following informaƟon/documents from the firm:‐ 1. Master Batch Formula duly cerƟfied by Quality Control Incharge showing the content of each input in the export product alongwith wastage claimed. Accordingly case was deferred for 12.04.2011.
Case No. A‐49A
M/s Watson Pharma Pvt. Ltd. F.No.01/82/162/00776/AM11/DES‐III 1. Master Batch Formula duly certified by Quality Control Incharge showing the content of each input in the export product alongwith wastage claimed.
Case No. A‐50
M/s Watson Pharma Pvt. Ltd. F.No.01/82/162/00774/AM11/DES‐III 1. Master Batch Formula duly certified by Quality Control Incharge showing the content of each input in the export product alongwith wastage claimed.
Case No. A‐51
M/s Watson Pharma Pvt. Ltd. F.No.01/82/162/00768/AM11/DES‐III 1. Master Batch Formula duly cerƟfied by Quality Control Incharge showing the content of each input in the export product alongwith wastage claimed.
Case No. A‐52
M/s Watson Pharma Pvt. Ltd. F.No.01/82/162/00772/AM11/DES‐III 1. Master Batch Formula duly cerƟfied by Quality Control Incharge showing the content of each input in the export product alongwith wastage claimed.
Case No. A‐53
M/s Watson Pharma Pvt. Ltd. F.No.01/82/162/00775/AM11/DES‐III
1. Master Batch Formula duly cerƟfied by Quality Control Incharge showing the content of each input in the export product alongwith wastage claimed.
Case No. A‐54
M/s Watson Pharma Pvt. Ltd. F.No.01/82/162/00777/AM11/DES‐III 1. Master Batch Formula duly cerƟfied by Quality Control Incharge showing the content of each input in the export product alongwith wastage claimed.
Case No. A‐55
M/s Watson Pharma Pvt. Ltd., Goa F.No.01/82/162/00769/AM11/DES‐III 1. Master Batch Formula duly cerƟfied by Quality Control Incharge showing the content of each input in the export product alongwith wastage claimed.
Case No. A‐56
M/s Watson Pharma Pvt. Ltd., Goa F.No.01/82/162/00770/AM11/DES‐III
1. Master Batch Formula duly cerƟfied by Quality Control Incharge showing the content of each input in the export product alongwith wastage claimed.
Case No. B‐389
M/s Gopinath Chem‐tech Ltd. Norms CommiƩee MeeƟng No. 46/11 F.No.01/82/050/01215/AM10/DES‐III RLA F. No. 08/24/040/00313/AM10 Adv. Lic. No.0810087248 dated 11.03.2010 CommiƩee decided to defer case for 01.03.2011 for comments of Department of C&PC.
Case No. B‐390
M/s FMC India Pvt. Ltd. F.No.01/82/50/00776/AM09/DES‐III RLA F.No.07/24/040/00192/AM10 Adv. Lic. No. 0710058651 dt. 22.07.08 CommiƩee decided to defer case for 01.03.2011 for comments of Department of C&PC.
Case No. B‐391
M/s Sarna Chemicals (P) Ltd. F.No.01/82/50/00093/AM11/DES‐III RLA F.No.03/95/040/00463/AM10 Adv. Lic. No. 0310546241 dated 18.11.2009 decided to amend the descripƟon of export product to read as “N‐Hydroxy Methyl 2‐Chloro Acetamide/XAW Base” without any other change in the decision taken in 5/82 meeƟng held on 04.05.2010. RA concerned may take further necessary acƟon as per above decision of NC.
Case No. B‐392
M/s Shilpa Medicare Ltd. F.No.01/83/50/00095/AM07/DES‐III RLA F.No.07/24/040/00046/AM07 Adv. Lic. No. 0710044550 dt. 26.04.2006 CommiƩee considered case as per agenda and in light of producƟon and consumpƟon data cerƟfied by Central Excise Authority and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 N‐[B‐D‐ 1 kg 1. Acetyl Tribenzoyl Ribofurnose 10.00 kg
Ribofuranosyl]‐5‐ Hydroxyimidazole‐4‐ Carboxamide Technical Grade 2. Stannic Chloride 6.00 kg 3. Tetrahydrofuran 7.04 kg 4. Methylene Dichloride 20.00 kg Note: Other items were not allowed as Central Excise cerƟfied ‘nil’ consumpƟon in respect of them.
Case No. B‐393
M/s Shilpa Medicare Ltd. F.No.01/83/50/01382/AM07/DES‐III RLA F.No.07/24/040/00879/AM07 Adv. Lic. No. 0710050972 dt. 29.03.2007 CommiƩee considered case as per agenda and in light of producƟon and consumpƟon data cerƟfied by Central Excise Authority and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 N‐[B‐D‐ Ribofuranosyl]‐5‐ Hydroxyimidazole‐4‐ Carboxamide Technical Grade 1 kg 1. Acetyl Tribenzoyl Ribofurnose 10.00 kg 2. Stannic Chloride 6.00 kg 3. Tetrahydrofuran 7.04 kg 4. Methylene Dichloride 20.00 kg Note:Other item were not allowed as Central Excise cerƟfied ‘nil’ consumpƟon in respect of them. RA concerned may take further necessary action as per above decision of NC.
Case No. B‐394
M/s Prachi PharmaceuƟcals Pvt. Ltd. F.No.01/82/50/00790/AM10/DES‐III RLA F.No.03/95/040/00565/AM10 Adv. Lic. No. 0310549028 dated 03.12.2009 decided to call for technical literature indicaƟng use of Potassium Iodide SoluƟon (Iodine content 25%) in the manufacture of export product from the firm. Accordingly, case was deferred for 12.04.2011.
Case No. B‐395
M/s Oneiro Chemicals Ltd. F.No.01/82/050/00460/AM09/DES‐III F.No.01/82/050/01101/AM09/DES‐III
F.No.01/82/050/01533/AM09/DES‐III F.No.01/82/050/00688/AM10/DES‐III F.No.01/82/050/01280/AM10/DES‐III F.No.01/82/050/00906/AM10/DES‐III RLA F.No.34/24/040/00024/AM09 RLA F.No.34/24/040/00123/AM09 RLA F.No.34/24/040/00188/AM09 RLA F.No.34/24/040/00099/AM10 RLA F.No.34/24/040/00127/AM10 RLA F.No.34/24/040/00182/AM10 Adv. Lic. No. 3410021377 dated 12.05.2008 Adv. Lic. No. 3410022428 dated 09.01.2009 Adv. Lic. No. 3410023179 dated 12.05.2008 Adv. Lic. No. 3410025106 dated 17.09.2009 Adv. Lic. No. 3410025589 dated 13.11.2010 Adv. Lic. No. 3410026154 dated 15.01.2010 Adv. Lic. No. 3410028128 dated 28.09.2010 CommiƩee considered case as per agenda. The representaƟve of Department of PharmaceuƟcals informed the CommiƩee that they have recommended import of Ammonium Persulphates to the extent of 2.43 kg/kg of export product in the case of this firm. CommiƩee also observed that the enhanced quanƟty of said input was allowed against old advance licences for regularizaƟon purpose only, on the basis of Central Excise data for the cases considered in NC MeeƟng No.33/11 dated 16.11.2010. A࿚�er detailed deliberaƟons and in consultaƟon with technical authoriƟes present in meeƟng, CommiƩee decided to reject the request of the firm for enhancement in the quanƟty of Ammonium Persulphates.
Case No. B‐396
M/s Aurobindo Pharma Ltd. F.No.01/82/50/01244/AM10/DES‐III RLA F.No.09/24/040/00546/AM10 Adv. Lic. No. 0910041467 dated 25.03.2010 CommiƩee considered case as per agenda and in light of ProducƟon and ConsumpƟon data cerƟfied by CA and in consultaƟon with technical authority present in meeƟng, decided to allow import of Quinaldic Acid [2‐ Quinoline Carboxylic Acid] to the extent of 0.4778 kg/kg of export product. CommiƩee also decided to delete import item No.2 i.e. AcƟvated Carbon and import item No.13 i.e. Tri Methyl Chlorosilane.
Case No. B‐362
M/s Vivimed Labs. Ltd. F.No.01/85/50/00236/AM10/DES‐III RLA F.No.09/24/040/00504/AM10
Adv. Lic. No. 0910041262 dt. 11.03.10 Withdrawn as the case has already been approved by NC in 42/11 meeƟng held on 18.01.2011. 1
Case No.:30/19/82‐ALC4/2009
Party Name:SURYA PHARMACEUTICAL LTD Meet No/Date:46/82‐ALC4/2010 15.02.2011 Status:Case Deferred HQ File :01/82/050/00408/AM10/ RLA File :22/24/040/00015/AM10/ Lic.No/Date:2210009018 22.06.2009 Defer Date:01.03.2011 Decision :CommiƩee considered case as per agenda and observed that the informaƟon received from the firm is incomplete because they have not given percentage yield. It was, therefore, decided to call the firm for personal hearing on 01.03.2011 alongwith complete informaƟon called from them. Accordingly, case was deferred for 01.03.2011. 2
Case No.:15/33/82‐ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 15.02.2011 Status:Case Rejected HQ File :01/82/050/00643/AM10/ RLA File :09/24/040/00240/AM10/ Lic.No/Date:0910039761 29.10.2009 Decision :CommiƩee considered case as per agenda and observed that the firm was requested to furnish technical informaƟon vide leƩer dated 23.07.2010, but no reply has been received and norms can not be fixed in absence of required technical informaƟon. It was, therefore, decided to reject the case. 3
Case No.:5/37/82‐ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 15.02.2011 Status:Case Deferred HQ File :01/82/050/00748/AM10/ RLA File :09/24/040/00325/AM10/ Lic.No/Date:0910039975 19.11.2009 Defer Date:15.03.2011 Decision :CommiƩee decided to defer case for 15.03.2011 for comments of Department of PharmaceuƟcals. 4
Case No.:19/46/82‐ALC4/2010
Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 15.02.2011 Status:Case Deferred HQ File :01/82/050/01574/AM11/ RLA File :03/94/040/01076/AM09/ Lic.No/Date:0310557395 28.01.2010 Defer Date:15.03.2011 Decision : CommiƩee considered case as per agenda and observed that the firm has not furnished technical details as per Appendix 33. It was, therefore, decided to call the firm for personal hearing alongwith technical details as per Appendix 33 on 15.03.2011. Accordingly, case was deferred for 15.03.2011. 5
Case No.:12/49/82‐ALC4/2009
Party Name:B. BRAUN MEDICAL (INDIA) PVT. LTD 15.02.2011 Status:Case Deferred
HQ File :01/82/050/01147/AM10/ RLA File :04/24/040/00144/AM10/ Lic.No/Date:0410111650 17.02.2010 Defer Date:15.03.2011 Decision : CommiƩee decided to defer case for 15.03.2011 for comments of Department of Animal Husbandary. It was alo decided to remind that Department in wriƟng as well as telephonically. 6
Case No.:15/2/82‐ALC4/2010
Party Name:COMBITIC GLOBAL CAPLET PVT. LTD. 15.02.2011 Status:Case Deferred HQ File :01/82/050/01249/AM10/ RLA File :33/24/040/00016/AM10/ Lic.No/Date:3310015180 26.03.2010 Defer Date:01.03.2011 Decision :CommiƩee considered case as per agenda. The representaƟve of the firm appeared before the CommiƩee for personal hearing and explained the case. A࿚�er hearing, CommiƩee asked the representaƟve of the firm to furnish AnalyƟc Report, copy of shipping bills and ConfirmaƟon from the buyer about the descripƟon of export product for which the representaƟve promised to furnish within 15 days. Accordingly, case was deferred for 01.03.2011. 7
Case No.:12/14/82‐ALC4/2010
Party Name:VDH INTERNATIONAL 15.02.2011 Status:Case Deferred HQ File :01/82/050/00374/AM11/ RLA File :05/24/040/00514/AM10/ Lic.No/Date:0510261659 01.04.2010 Defer Date:15.03.2011 Decision :CommiƩee considered case as per agenda and in light of Department of C&PCs leƩer No.14010/58/2010/Ch.II dated 14.09.2010, decided to remind the firm to furnish the following informaƟon:‐ 1. Chemical reacƟons with molecular and structural formula and molecular weight. 2. Stage‐wise percentage yields. 3. Material balance. 4. Chartered Accountant’s cerƟficate regarding past three years producƟon of export item and corresponding consumpƟon of different raw materials. 5. Details of by‐product/co‐products formed in the above producƟon with quanƟƟes and values cerƟfied by CA. 6. AuthenƟc technical literature in support of manufacturing process and norms applied for import. 7. ComposiƟon of Metal Para Cresol supported with authenƟc technical literature. Accordingly, the case was deferred for 15.03.2011. 8
Case No.:33/6/82‐ALC4/2010
Party Name:ARCH PHARMALABS LTD 15.02.2011 Status:Case Approved HQ File :01/82/050/00180/AM11/ RLA File :03/94/040/00030/AM11/ Lic.No/Date:0310572376 30.04.2010 Decision : CommiƩee considered case as per agenda and in light of earlier decision taken in 45/82 meeƟng held on 08.02.2011 and in consultaƟon with representaƟve of Department of PharmaceuƟcals present in meeƟng, decided to raƟfy 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 (1R,2S,5S)‐6,6‐Dimethyl‐3‐ 1 kg 1. Caronic Anhydrate 3.029 kg
Azabicyclo[3.1.0]Hexane‐2‐ Carboxylic Acid methyl Ester hydrochloride (BPVR503034‐ T) 2. Vitride [Sodium Bis(2‐Methoxyethoxy) Aluminium 20.00 kg 3. Lypholized Enzyme Powder (CDX‐616) 0.076 kg 9
Case No.:135/9/82‐ALC4/2010
Party Name:SAINOR LABORATORIES PVT LTD 15.02.2011 Status:Case Deferred HQ File :01/82/050/00350/AM11/ RLA File :09/24/040/00040/AM11/ Lic.No/Date:0910042075 19.05.2010 Defer Date:15.03.2011 Decision : CommiƩee decided to defer case for 15.03.2011 for comments of Department of C&PC. 10
Case No.:10/26/82‐ALC4/2010
Party Name:VIVIMED LABS LIMITED 15.02.2011 Status:Case Deferred HQ File :01/82/050/00828/AM11/ RLA File :09/24/040/00058/AM11/ Lic.No/Date:0910042154 31.05.2010 Defer Date:15.03.2011 Decision :CommiƩee considered case as per agenda and observed that the descripƟon of export product given by the firm is incomplete because they have not given percentage of Grannules. It was, therefore, decided to call from the firm complete descripƟon of export product including percentage of Grannules alongwith copy of corresponding Drug Manufacturing Licence. Accordingly, case was deferred for 15.03.2011. 11
Case No.:33/26/82‐ALC4/2010
Party Name:CIPLA LIMITED 15.02.2011 Status:Case Approved HQ File :01/82/050/00851/AM11/ RLA File :03/94/040/00216/AM11/ Lic.No/Date:0310576655 01.06.2010 Decision : CommiƩee considered case as per agenda and in light of earlier decision taken in 45/82 meeƟng held on 081.02.2011 and in consultaƟon with representaƟve of Department of PharmaceuƟcals present in meeƟng, decided to raƟfy 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 Levofloxacin Hemihydrate 1 kg 1. (S)9,10‐Difluoro‐3‐Methyl‐7‐oxo‐2,3‐ Dihydro‐7H‐Pyrido[1,2,3‐de] [1,4]benzoxazine‐6‐carboxylic acid ethyl ester (LVF‐3) 1.265 kg 2. N‐Methyl Piperazine 0.432 kg
12
Case No.:34/22/82‐ALC4/2010
Party Name:WEXFORD LABORATORIES P LTD 15.02.2011 Status:Case Approved HQ File :01/82/050/00687/AM11/ RLA File :07/24/040/00074/AM11/ Lic.No/Date:0710072310 17.06.2010 Decision : CommiƩee considered case as per agenda and in consultaƟon with technical authority present in meeƟng decided to raƟfy 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 InjecƟon of Vitamin B1,B6 & B12 with Hydroxocobalamin‐3 ml (MEGABION) 1 Vial 1. Vitamin B12 (Hydroxocobalamin acetate) 13.75 mg/vial 13
Case No.:108/22/82‐ALC4/2010
Party Name:MEDCHL CHEMICALS AND PHARMACEUTICALS PVT LTD 15.02.2011 Status:Case Deferred HQ File :01/82/050/00761/AM11/ RLA File :09/24/040/00028/AM11/ Lic.No/Date:0910042684 14.07.2010 Defer Date:15.03.2011 Decision : CommiƩee decided to defer case for 15.03.2011 for comments of Department of PharmaceuƟcals. 14
Case No.:97/22/82‐ALC4/2010
Party Name:TONIRA PHARMA LTD, 15.02.2011 Status:Case Deferred HQ File :01/82/050/00750/AM11/ RLA File :34/24/040/00073/AM11/ Lic.No/Date:3410027520 16.07.2010 Defer Date:15.03.2011 Decision : CommiƩee decided to defer case for 15.03.2011 for comments of Department of PharmaceuƟcals. 15
Case No.:85/22/82‐ALC4/2010
Party Name:CIPLA LIMITED 15.02.2011 Status:Case Approved HQ File :01/82/050/00738/AM11/ RLA File :03/94/040/00350/AM11/ Lic.No/Date:0310584093 19.07.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their U.O. No.35011/241/2008‐PI‐III dated 17.03.2009 and in consultaƟon with technical authority present in meeƟng decided to raƟfy 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 SoluƟon 50 mg/5 ml, 100 ml boƩle (Nevirapine = 1020 mg/100 ml boƩle) 1 No. 5. Sodium Hydride 0.44 kg/kg of Nevirapine 6. Ethyl Acetate 1.70 kg/kg of Nevirapine 16
Case No.:22/46/82‐ALC4/2010
Party Name:GITANJALI CHEMICALS PVT LTD 15.02.2011 Status:Case Approved HQ File :01/82/050/01577/AM11/ RLA File :03/94/040/00262/AM11/ Lic.No/Date:0310584760 23.07.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their 14010/6/2008‐Ch.III dated 2306.2008 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm Export product Exp. Qty. Sl.No. Import items Qty. allowed 2,4,6 Trichloro Phenol 1 Kg. 1. Phenol 0.602 kg 17
Case No.:29/26/82‐ALC4/2010
Party Name:SARACA LABORATORIES LTD 15.02.2011 Status:Case Approved HQ File :01/82/050/00847/AM11/ RLA File :09/24/040/00163/AM11/ Lic.No/Date:0910042998 06.08.2010 Decision : CommiƩee considered case as per agenda and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 GabapenƟn Hcl (Technical Powder) 1 Kg. 1. 1,1 Cyclohexane Di AceƟc Acid Monoamide (CAM) 0.988 kg 2. Bromine 0.923 kg
18
Case No.:20/46/82‐ALC4/2010
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 15.02.2011 Status:Case Approved HQ File :01/82/050/01575/AM11/ RLA File :03/94/040/00390/AM11/ Lic.No/Date:0310586284 06.08.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O.No.14010/9/2005‐Ch.II dated 25.10.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm Export Product Export Qty. Sl.No. Import items Qty. allowed Astrolide in Diethyl Phthalate/Isopropyl Myristate/Benzyl Benzoate Main Total Astrolide content 62.5% minimum 1 kg 1. Isoamylene 0.380 kg 2. Propylene Oxide 0.280 kg 3. Isopropyl Myristrate 0.350 kg 19
Case No.:13/46/82‐ALC4/2010
Party Name:FINE ORGANIC INDUSTRIES PVT. LTD. 15.02.2011 Status:Case Approved HQ File :01/82/050/01568/AM11/ RLA File :03/94/040/00393/AM11/ Lic.No/Date:0310586845 10.08.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their 14010/39/2008‐Ch.II dated 04.12.2009 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm Export product Exp. Qty. Sl.No. Import items Qty. allowed Glyceryl Oleate 1 Kg. 1. Glycerine 0.273 kg 2. Oleic Acid Commercial 0.832 kg 20
Case No.:34/26/82‐ALC4/2010
Party Name:DALAS BIOTECH LTD. 15.02.2011 Status:Case Approved HQ File :01/82/050/00852/AM11/ RLA File :05/23/040/00122/AM11/ Lic.No/Date:0510270364 11.08.2010 Decision : CommiƩee considered case as per agenda and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Pavest 1 Kg. 1. 7‐Pheylacetamideo‐3‐Chloromethyl Cephalosporanic Acid Para Methoxybenzyl Ester (GCLE) 1.274 kg 2. Tri Phenyl Phosphine 0.70 kg 3. Methylene Chloride 2.45 kg 21
Case No.:14/46/82‐ALC4/2010
Party Name:FINE ORGANIC INDUSTRIES, 15.02.2011 Status:Case Approved HQ File :01/82/050/01569/AM11/ RLA File :03/94/040/00399/AM11/ Lic.No/Date:0310587052 11.08.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their 14010/153/2001‐Ch.III dated 12.02.2011 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm Export product Exp. Qty. Sl.No. Import items Qty. allowed Neutralized Amide Ester (Ethanol Amide Stearate) 1 Kg. 1. Stearic Acid 1.064 kg 2. Mono Ethanol Amine 0.114 kg 22
Case No.:21/46/82‐ALC4/2010
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 15.02.2011 Status:Case Approved HQ File :01/82/050/01576/AM11/ RLA File :03/94/040/00422/AM11/ Lic.No/Date:0310587047 11.08.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/53/2010‐Ch.II dated 10.06.2010 and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy 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 Camphor USP 1 Kg. 1. Alpha Pinene 1.15 kg 23
Case No.:4/22/82‐ALC4/2010
Party Name:MEHTA (API) PVT.LTD 15.02.2011 Status:Case Approved
HQ File :01/82/050/00657/AM11/ RLA File :03/95/040/00358/AM11/ Lic.No/Date:0310587875 16.08.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments of Department of PharmaceuƟcals and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy 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 Des Azithromycin/Desmethyl Azithromycin CAS Registry No.76801‐85‐9 1 Kg. 1. Erythromycin Thiocynate 1.640 KGA 2. Hydroxyamine Hydrochloride 0.87 kg 3. Para Toluene Sulfonyl Chloride 0.407 kg 4. Methanol 3.00 kg 5. Methylene Chloride/Acetone 1.27 kg 6. 5% PlaƟnum on Charcoal 0.00105 kg 24
Case No.:35/26/82‐ALC4/2010
Party Name:DHANUKA LABORATORIES LTD. 15.02.2011 Status:Case Approved HQ File :01/82/050/00853/AM11/ RLA File :05/23/040/00085/AM11/ Lic.No/Date:0510271131 20.08.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/43/2008‐PI‐III dated 17.07.2008 and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Cefdinir 1 Kg. 1. 7‐Phenylacetamideo‐3 Chloromethyl Cephalosporanic Acid Para Methoxy Benzyl Ester (GCLE) 2.44 kg 2. Triphenyl Phosphene 2.249 kg 3. Phenol 2.42 kg 4. Methanol 7.12 kg 5. Methylene Chloride 23.64 kg 6. Tetra Hydro Furan 3.91 kg 7. Acetone 3.21 kg 8. (Z)‐2‐(2‐Zminothiazole‐4YL)‐2‐Hydroxyimino AceƟc (ATHIAA) 1.097 kg 9. Sodium Iodide 0.76 kg 25
Case No.:26/26/82‐ALC4/2010
Party Name:NECTAR LIFESCIENCES LIMITED, 15.02.2011 Status:Case Approved
HQ File :01/82/050/00844/AM11/ RLA File :22/24/040/00035/AM11/ Lic.No/Date:2210010327 24.08.2010 Decision :CommiƩee considered case as per agenda and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as applied by the firm. 26
Case No.:3/24/82‐ALC4/2010
Party Name:ARCH PHARMALABS LTD 15.02.2011 Status:Deffered and Re‐indexed HQ File :01/82/050/00803/AM11/ RLA File :03/94/040/00487/AM11/ Lic.No/Date:0310590555 01.09.2010 Defer Date:15.02.2011 Decision : CommiƩee considered case as per agenda and in light of earlier decision taken in 45/82 meeƟng held on 08.02.2011 and in consultaƟon with representaƟve of Department of PharmaceuƟcals present in meeƟng, decided to raƟfy 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 (1R,2S,5S)‐6,6‐Dimethyl‐3‐ Azabicyclo[3.1.0]Hexane‐2‐ Carboxylic Acid methyl Ester hydrochloride (BPVR503034‐ T) 1 kg 1. Caronic Anhydrate 3.029 kg 2. Vitride [Sodium Bis(2‐Methoxyethoxy) Aluminium 20.00 kg 3. Lypholized Enzyme Powder (CDX‐616) 0.076 kg 27
Case No.:16/46/82‐ALC4/2010
Party Name:LUPIN LIMITED 15.02.2011 Status:Case Approved HQ File :01/82/050/01571/AM11/ RLA File :03/95/040/00415/AM11/ Lic.No/Date:0310591519 08.09.2010 Decision : CommiƩee considered case as per agenda and in light of earlier decision taken in 23/82 meeƟng held on 07.09.2010 and in consultaƟon of Technical authoriƟes present in the meeƟng decided to raƟfy 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 RifapenƟne 150 mg tablets(Rifapex150 mg) 1 kg 1. RifapenƟne) 1.02kg 28
Case No.:2/26/82‐ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 15.02.2011 Status:Case Deferred
HQ File :01/82/050/00820/AM11/ RLA File :09/24/040/00226/AM11/ Lic.No/Date:0910043503 14.09.2010 Defer Date:15.03.2011 Decision : CommiƩee decided to defer case for 15.03.2011 for comments of Department of PharmaceuƟcals. 29
Case No.:37/26/82‐ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 15.02.2011 Status:Case Deferre HQ File :01/82/050/00855/AM11/ RLA File :09/24/040/00252/AM11/ Lic.No/Date:0910043534 16.09.2010 Defer Date:15.03.2011 Decision : CommiƩee decided to defer case for 15.03.2011 for comments of Department of PharmaceuƟcals. 30
Case No.:49/26/82‐ALC4/2010
Party Name:SUVEN LIFE SCIENCES LIMITED 15.02.2011 Status:Case Approved HQ File :01/82/050/00867/AM11/ RLA File :09/24/040/00245/AM11/ Lic.No/Date:0910043540 17.09.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/332/2009‐PI‐(Norms) dated 09.01.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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. N‐Methylformaniolde 0.083 kg 5. Methanol 2.31 kg 31
Case No.:35/46/82‐ALC4/2010
Party Name:STERLING AUXILIARIES PVT LTD 15.02.2011 Status:Case Deferred HQ File :01/82/050/01590/AM11/ RLA File :03/95/040/00482/AM11/ Lic.No/Date:0310594709 01.10.2010 Defer Date:15.03.2011 Decision : CommiƩee decided to defer case for 15.03.2011 for comments of Department of C&PC. 32
Case No.:6/30/82‐ALC4/2010
Party Name:ALCON BIOSCIENCES PRIVATE LIMITED Meet No/Date:46/82‐ALC4/2010 15.02.2011 Status:Case Deferred HQ File :01/82/050/00925/AM11/ RLA File :03/94/040/00472/AM11/ Lic.No/Date:0310595543 06.10.2010 Defer Date:12.04.2011
Decision :CommiƩee decided to call for a copy of applicaƟon from RA/firm. Accordingly, case was deferred for 12.04.2011. 33
Case No.:5/30/82‐ALC4/2010
Party Name:VIC INDUSTRIES, 15.02.2011 Status:Case Approved HQ File :01/82/050/00924/AM11/ RLA File :17/24/040/00064/AM09/ Lic.No/Date:1710003530 07.10.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/115/2007/Ch.II dated 06.05.2008 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Product AP‐05 Containing 50% of Phosphated Ester of 2 Ethyl Hexanol (50%) 10%of Propylene Glycol 40% in water 1 Kg. 1. 2 Ethyl Hexanol 0.365 kg 2. Phosphorous Pentoxide 0.135 kg 3. Propylene Glycol 0.100 kg 34
Case No.:17/46/82‐ALC4/2010
Party Name:LUPIN LIMITED 15.02.2011 Status:Case Approved HQ File :01/82/050/01572/AM11/ RLA File :03/95/040/00519/AM11/ Lic.No/Date:0310596109 11.10.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/152/2010‐PI‐(Norms) dated 25.11.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 LeveƟracetam 1 Kg. 1. Ethyl Acetate 1.49 kg 2. Methanol 0.71 kg 3. Methylene Chloride 3.74 kg 4. AcƟvated Carbon 0.0128 kg 5. Methyl 2 Bromo Butyrate 2.9117 kg 6. Potassium Carbonate 1.0925 kg 7. L(+) Tartaric Acid 0.87 kg 8. Methanol 7.2656 kg 9. CausƟc Soda Lye 0.4892 kg 10. Iso Propyl Alcohol 1.3119 kg
35
Case No.:18/46/82‐ALC4/2010
Party Name:ENALTEC LABS PVT.LTD. 15.02.2011 Status:Case Approved HQ File :01/82/050/01573/AM11/ RLA File :03/94/040/00587/AM11/ Lic.No/Date:0310596381 12.10.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/238/2009‐PI‐(Norms) dated 28.01.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Montelukast Sodium 1 Kg. 1. 2[3(S)‐[3‐[2‐[7‐Chloroquinoline‐2‐yl)Ethyl Phenyl]‐3‐ Hydroxyproane]Benzene‐2‐Propanol 1.43 kg 2. 2‐(1‐Mercaptomethyl) Cyclopropyl)AceƟc Acid 0.60 kg 36
Case No.:23/46/82‐ALC4/2010
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 15.02.2011 Status:Case Approved HQ File :01/82/050/01578/AM11/ RLA File :03/94/040/00624/AM11/ Lic.No/Date:0310597668 19.10.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/9/2005‐Ch.II dated 25.10.2010 and earlier decision taken in 36/82 meeƟng held on 07.12.2010 and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy 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 Astrolide in Diemethyl Phthalate.Isopropyl Myristate/Benzyl Benzoate Main Total Astrolide content 62.5% Minimum 1 Kg. 1. Alpha Methyl Styrene 0.500 kg 2. Isoamylene 0.380 kg 3. Propylene Oxide 0.280 kg 4. Para Formaldehyde 0.088 kg 5. Dipropylene Glycol 0.350 kg 37
Case No.:15/46/82‐ALC4/2010
Party Name:FINE ORGANIC INDUSTRIES PVT. LTD. 15.02.2011 Status:Case Approved HQ File :01/82/050/01570/AM11/ RLA File :03/94/040/00648/AM11/ Lic.No/Date:0310598246 22.10.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/39/2008‐Ch.II
p g g y p / / dated 27.03.2009 and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy 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 Sorbitan Tristearate 1 Kg. 1. Stearic Acid (Stearic Acid content 50 + 10% Stearic Acid + PlamiƟc Acid content 90% Min.) 0.915 kg 2. Sorbitol 0.195 kg 38
Case No.:3/34/82‐ALC4/2010
Party Name:GALPHA LABORATORIES LIMITED, 15.02.2011 Status:Case Deferred HQ File :01/82/050/01009/AM11/ RLA File :03/94/040/00638/AM11/ Lic.No/Date:0310600646 09.11.2010 Defer Date:15.03.2011 Decision :CommiƩee decided to defer case for 15.03.2011 for comments of Department of PharmaceuƟcals. 39
Case No.:7/34/82‐ALC4/2010
Party Name:SUPREET CHEMICALS PVT.LTD. 15.02.2011 Status:Case Approved HQ File :01/82/050/01013/AM11/ RLA File :03/95/040/00643/AM11/ Lic.No/Date:0310600876 11.11.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/42/2005‐Ch.II dated 01.02.2011 and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy 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 40
Case No.:24/46/82‐ALC4/2010
Party Name:KLJ PLASTICIZERS LTD, 15.02.2011 Status:Case Approved HQ File :01/82/050/01579/AM11/ RLA File :05/23/040/00230/AM11/ Lic.No/Date:0510278037 26.11.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/2/2010‐Ch.II dated 13.09.2010 and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm Export product Exp. Qty. Sl.No. Import items Qty. allowed
Kanatol 1010 (Di‐Propyl Heptyl Phthalate) 1 Kg. 1. Propyl Heptanol 0.746 kg 2. Phthalic Anhydride 0.350 kg 41
Case No.:25/46/82‐ALC4/2010
Party Name:KLJ PLASTICIZERS LTD, 15.02.2011 Status:Case Approved HQ File :01/82/050/01580/AM11/ RLA File :05/23/040/00231/AM11/ Lic.No/Date:0510278040 26.11.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/2/2010‐Ch.II dated 13.09.2010 and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm Export product Exp. Qty. Sl.No. Import items Qty. allowed Kanatol 1010 (Di‐Propyl Heptyl Phthalate) 1 Kg. 1. Propyl Heptanol 0.746 kg 2. Phthalic Anhydride 0.350 kg 42
Case No.:34/46/82‐ALC4/2010
Party Name:KLJ PLASTICIZERS LTD, 15.02.2011 Status:Case Approved HQ File :01/82/050/01589/AM11/ RLA File :05/23/040/00232/AM11/ Lic.No/Date:0510278042 26.11.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/2/2010‐Ch.II dated 13.09.2010 and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm Export product Exp. Qty. Sl.No. Import items Qty. allowed Kanatol 1010 (Di‐Propyl Heptyl Phthalate) 1 Kg. 1. Propyl Heptanol 0.746 kg 2. Phthalic Anhydride 0.350 kg 43
Case No.:28/46/82‐ALC4/2010
Party Name:VIVIMED LABS LIMITED 15.02.2011 Status:Case Deferred HQ File :01/82/050/01583/AM11/ RLA File :09/24/040/00295/AM11/ Lic.No/Date:0910044520 01.12.2010 Defer Date:15.03.2011 Decision :CommiƩee decided to defer case for 15.03.2011 for comments of Department of C&PC.
44
Case No.:30/46/82‐ALC4/2010
Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 15.02.2011 Status:Case Approved HQ File :01/82/050/01585/AM11/ RLA File :09/24/040/00390/AM11/ Lic.No/Date:0910044557 03.12.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments of Department of C&PC dated 11.02.2011 and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy 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 Imidazolidinyl Urea 46% (Liquid) 1 Kg. 1. Imidazolidinyl Urea (White Fine Powder) 0.460 kg 45
Case No.:32/46/82‐ALC4/2010
Party Name:LEPRO HERBALS PVT. LTD. 15.02.2011 Status:Case Approved HQ File :01/82/050/01587/AM11/ RLA File :05/23/040/00235/AM11/ Lic.No/Date:0510278803 07.12.2010 Decision : CommiƩee considered case as per agenda and in light of earlier decision taken in 38/82 meeƟng held on 01.01.2008 and 26/11 meeƟng held on 28.09.2010 and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy 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 GlycyrrheƟnic Acid (18 Beta GlycyrrheƟnic Acid) 1 Kg. 1. Glycyrrhizic Acid 11.50 kg 46
Case No.:33/46/82‐ALC4/2010
Party Name:LEPRO HERBALS PVT. LTD. 15.02.2011 Status:Case Approved HQ File :01/82/050/01588/AM11/ RLA File :05/23/040/00238/AM11/ Lic.No/Date:0510278805 07.12.2010 Decision : CommiƩee considered case as per agenda and in light of earlier decision taken in 4/82 meeƟng held on 30.05.2007 and 26/11 meeƟng held on 28.09.2010 and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy 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 Enoxolone EO/BP 1 Kg. 1. Glycyrrhizic Acid 25% 12.65 kg
47
Case No.:12/46/82‐ALC4/2010
Party Name:FINE ORGANIC INDUSTRIES, 15.02.2011 Status:Case Approved HQ File :01/82/050/01567/AM11/ RLA File :03/94/040/00803/AM11/ Lic.No/Date:0310605996 13.12.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their 14010/153/2001‐Ch.III dated 12.02.2011 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm Export product Exp. Qty. Sl.No. Import items Qty. allowed Neutralized Amide Ester (Ethanol Amide Stearate) 1 Kg. 1. Stearic Acid 1.064 kg 2. Mono Ethanol Amine 0.114 kg 48
Case No.:29/46/82‐ALC4/2010
Party Name:SRINI PHARMACEUTICALS LTD., 15.02.2011 Status:Case Deferred HQ File :01/82/050/01584/AM11/ RLA File :09/24/040/00389/AM11/ Lic.No/Date:0910044669 13.12.2010 Defer Date:15.03.2011 Decision : CommiƩee decided to defer case for 15.03.2011 for comments of Department of PharmaceuƟcals. 49
Case No.:10/46/82‐ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 15.02.2011 Status:Case Deffered HQ File :01/82/050/01565/AM11/ RLA File :09/24/040/00427/AM11/ Lic.No/Date:0910044877 24.12.2010 Defer Date:12.04.2011 Decision : CommiƩee decided to defer case for 12.04.2011 for comments of Department of PharmaceuƟcals. 50
Case No.:11/46/82‐ALC4/2010
Party Name:BIOLOGICAL E LTD 15.02.2011 Status:Case Added HQ File :01/82/050/01566/AM11/ RLA File :09/24/040/00353/AM11/ Lic.No/Date:0910044878 24.12.2010 Decision : CommiƩee considered case as per agenda and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Heparin Sodium BP 1 Kg. 1. Crude Heparin Sodium Potency: 145 IU/MG 1.055 kg 51
Case No.:9/46/82‐ALC4/2010
Party Name:MECK PHARMACEUTICALS AND Status:Case
CHEMICALS PVT.LTD. 15.02.2011 Deferred HQ File :01/82/050/01564/AM11/ RLA File :08/24/040/00165/AM11/ Lic.No/Date:0810094956 27.12.2010 Defer Date:15.03.2011 Decision :CommiƩee decided to forward a copy of applicaƟon to Department of C&PC for their comments. Accordingly, case was deferred for 15.03.2011. 52
Case No.:26/46/82‐ALC4/2010
Party Name:SHIVA PHARMACHEM LTD, 15.02.2011 Status:Case Approved HQ File :01/82/050/01581/AM11/ RLA File :34/24/040/00252/AM11/ Lic.No/Date:3410028991 31.12.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their 14010/101/2002‐Ch.II dated 04.10.2007 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm Export product Exp. Qty. Sl.No. Import items Qty. allowed 2‐Ethyl Hexanoyl Chloride 1 Kg. 1. 2‐Ethyl Hexanoic Acid 0.925 kg 2. Thionyl Chloride 0.638 kg 53
Case No.:27/46/82‐ALC4/2010
Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD 15.02.2011 Status:Case Approved HQ File :01/82/050/01582/AM11/ RLA File :34/24/040/00266/AM11/ Lic.No/Date:3410029093 13.01.2011 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their 14010/34/2003‐Ch.III dated 13.07.2007 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm Export product Exp. Qty. Sl.No. Import items Qty. allowed Tetra Octyl Ammonium Bromide 1 Kg. 1. Tri‐n‐Octyl Amine 0.718 kg 2. Octyl Alcohol 0.294 kg 54
Case No.:31/46/82‐ALC4/2010
Party Name:SHIVA PHARMACHEM LTD, 15.02.2011 Status:Case Approved HQ File :01/82/050/01586/AM11/ RLA File :34/24/040/00271/AM11/ Lic.No/Date:3410029154 24.01.2011 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their 14010/84/2006‐Ch.II dated 11.10.2006 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm
Export product Exp. Qty. Sl.No. Import items Qty. allowed n‐Valery Chloride 1 Kg. 1. n‐Valeric Acid 0.891 kg 2. Thionyl Chloride 0.932 kg 55
Case No.:1/46/82‐ALC4/2010
Party Name:TECKBOND LABORATORIES PRIVATE LIMITED 15.02.2011 Status:Case Deferred HQ File :01/82/050/01556/AM11/ RLA File :09/24/040/00498/AM11/ Lic.No/Date:0910045399 03.02.2011 Defer Date:15.03.2011 Decision : CommiƩee decided to defer case for 15.03.2011 for comments of Department of PharmaceuƟcals. 56
Case No.:2/46/82‐ALC4/2010
Party Name:KLJ PLASTICIZERS LTD, 15.02.2011 Status:Case Approved HQ File :01/82/050/01557/AM11/ RLA File :05/23/040/00313/AM11/ Lic.No/Date:0510283073 03.02.2011 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their 14010/2/2010‐Ch.II dated 04.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm Export product Exp. Qty. Sl.No. Import items Qty. allowed Kanatol 400 (Di‐Iso/N‐Butyl Phthalate) 1 Kg. 1. Phthalic Anhydride 0.560 kg 2. Iso/Normal Butanol 0.560 kg 57
Case No.:3/46/82‐ALC4/2010
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 15.02.2011 Status:Case Approved HQ File :01/82/050/01558/AM11/ RLA File :03/95/040/00852/AM11/ Lic.No/Date:0310614296 04.02.2011 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments of Department of C&PC dated 12.02.2011 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 1 Amino Benzotrifluoride (99.5% extra pure) 1 Kg. 1. 2 Amino Benzo Trifluoride (99%) 1.05 kg
58
Case No.:4/46/82‐ALC4/2010
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 15.02.2011 Status:Case Approved HQ File :01/82/050/01559/AM11/ RLA File :09/24/040/00502/AM11/ Lic.No/Date:0910045454 07.02.2011 Decision : CommiƩee considered case as per agenda and in light of earlier decision taken in 31/82 meeƟng held on 02.11.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 1,1‐Cyclohexane DiaceƟc Anhydride 1 Kg. 1. 1,1 Cyclohexane DiaceƟc Acid 1.145 kg 59
Case No.:5/46/82‐ALC4/2010
Party Name:TORRENT PHARMACEUTICALS LTD. 15.02.2011 Status:Case Approved HQ File :01/82/050/01560/AM11/ RLA File :08/24/040/00335/AM11/ Lic.No/Date:0810096099 07.02.2011 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/185/2009‐PI‐(Norms) dated 01.01.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Acemetacin 30 mg Capsule 1 No. 1. Acemetacin 30.6 mg/capsule Acemetacin 60 mg Capsule 1 No. 1. Acemetacin 61.20 mg/capsule 60
Case No.:6/46/82‐ALC4/2010
Party Name:TORRENT PHARMACEUTICALS LTD. 15.02.2011 Status:Case Approved HQ File :01/82/050/01561/AM11/ RLA File :08/24/040/00336/AM11/ Lic.No/Date:0810096100 07.02.2011 Decision : CommiƩee considered case as per agenda and taking cue from SION at Sl.No.A‐412 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Propafenone Tablet 150 mg Propafenone 150 Heumann 1 No. 1. Propafenone Hcl 153 mg Propafenone Tablet 300 mg Propafenone 300 Heumann 1 No. 1. Propafenone Hcl 306 mg
61
Case No.:7/46/82‐ALC4/2010
Party Name:INDO PHYTOCHEM PHARMACEUTICALS 15.02.2011 Status:Case Approved HQ File :01/82/050/01562/AM11/ RLA File :05/23/040/00314/AM11/ Lic.No/Date:0510283333 07.02.2011 Decision : CommiƩee considered case as per agenda and in light of its earlier decision taken in its 18/82 meeƟng held on 29.07.2008 vide case No.15/18/82‐ ALC4/2008 and in consultaƟon with technical authority present in meeƟng decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm Export product Export Qty. Sl.No. Import items Qty. allowed Yohimbine Hydrochloride USP 1 Kg. 1. Yohimbine Bark (containing Yohimbine content maximum 1‐1.2%) 133.44 kg 62
Case No.:8/46/82‐ALC4/2010
Party Name:VARUN MEDIMPEX INC. 15.02.2011 Status:Case Deferred HQ File :01/82/050/01563/AM11/ RLA File :05/24/040/00363/AM11/ Lic.No/Date:0510283385 08.02.2011 Defer Date:15.03.2011 Decision : CommiƩee decided to defer case for 15.03.2011 for comments of Department of C&PC, PC Division.
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