DGFT Committee Minutes
Case No.B 418
M/s. Sandoz Pvt. Ltd. Norms Committee Meeting No.27/AM13 F.No. 01/82/162/00283/AM 13/DES III F.No. 01/82/162/00287/AM 13/DES III F.No. 01/82/162/00284/AM 13/DES III F.No. 01/82/162/00286/AM 13/DES III F.No. 01/82/162/00296/AM 13/DES III Meeting Date:31.12.2012 Decision: It was decided to defer the case for 24.01.2013 for comments of Department of Pharmaceuticals.
Case No.B 419
M/s. Sandoz Pvt. Ltd. F.No. 01/82/162/00285/AM 13/DES III F.No. 01/82/162/00292/AM 13/DES III F.No. 01/82/162/00303/AM 13/DES III F.No. 01/82/162/00290/AM 13/DES III Office of Directorate General of Foreign Trade New Delhi 0
Para 4.7 Decision
MEETING NUMBER : 27/82‐ALC4/2012 MEETING DATE : 29.12.2012 The Meeting No.27/82 in the year 201213 to consider the cases under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to products falling in Chapter 29 and 30 was scheduled to be held on 27.12.2012 but was actually held on 31.12.2012 under the Chairmanship of Addl DGFT, Shri Mukesh Bhatnagar in Room No. 4, Udyog Bhawan, New Delh.. Following members were present: 1. Shri S.K. Aggarwal, Jt. Development Commissioner, DC(MSME) 2. Shri D.N. Mathur, Consultant, Department of Pharmaceutical 3 Shri R.C. Meena, Dy. Director General of Foreign Trade
Case No.B 422
M/s. Sandoz Pvt. Ltd. F.No. 01/82/162/00294/AM 13/DES III F.No. 01/82/162/00293/AM 13/DES III Meeting Date:31.12.2012 Decision: It was decided to defer the case for 24.01.2013 for comments of DOP.
Case No.B 420
M/s. Sandoz Pvt. Ltd. F.No. 01/82/162/00300/AM 13/DES III F.No. 01/82/162/00301/AM 13/DES III F.No. 01/82/162/00302/AM 13/DES III F.No. 01/82/162/00289/AM 13/DES III F.No. 01/82/162/00288/AM 13/DES III Meeting Date:31.12.2012 Decision: It was decided to defer the case for 24.01.2013 for comments of Department of Pharmaceuticals.
Case No.B 421
M/s. Sandoz Pvt. Ltd. F.No. 01/82/162/00291/AM 13/DES III F.No. 01/82/162/00298/AM 13/DES III F.No. 01/82/162/00297/AM 13/DES III F.No. 01/82/162/00299/AM 13/DES III F.No. 01/82/162/00305/AM 13/DES III Meeting Date:31.12.2012 Decision: It was decided to defer the case for 24.01.2013 for comments of Department of Pharmaceuticals.
g F.No. 01/82/162/00307/AM 13/DES III F.No. 01/82/162/00306/AM 13/DES III F.No. 01/82/162/00304/AM 13/DES III F.No. 01/82/162/00308/AM 13/DES III Meeting Date:31.12.2012 Decision: It was decided to defer the case for 24.01.2013 for comments of Department of Pharmaceuticals.
Case No.B 423
M/s. Sandoz Pvt. Ltd. F.No. 01/82/162/00309/AM 13/DES III F.No. 01/82/162/00310/AM 13/DES III F.No. 01/82/162/003114/AM 13/DES III F.No. 01/82/162/00312/AM 13/DES III F.No. 01/82/162/00313/AM 13/DES III Meeting Date:31.12.2012 Decision: It was decided to defer the case for 24.01.2013 for comments of Department of Pharmaceuticals.
Case No.B 424
M/s. Shamrock Pharmachem Pvt. Ltd. F.No. 01/82/050/01448/AM11/DES III Meeting Date: 31.12.2012 Advance licence No. & date 0310609520 dated 05.01.2011 Decision: Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their F.No. No.35011/574/2012PI (Norms) dated 27.12.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg 1‐(3‐CHLOROPHENYL)‐1‐ PROPANONE 1 Kg. 1. PROPIOPHENONE 1.39 2. ETHYLENE DICHLORIDE 2.27 3. TETRA HYDRO FURAN 1.70 4. DIMETHYL FORMAMIDE 2.00 RA concerned may take further necessary action as per above decision of NC
co ce ed ay ta e u t e ecessa y act o as pe abo e dec s o o C
Case No.B 425
M/s. SALVI CHEMICAL INDUSTRIES LIMITED Norms Committee Meeting No.25/AM13 F.No. 01/82/050/00993/AM12/DES III Meeting Date: 29.11.2012 RA F.No. 03/95/040/00718/AM12 Advance licence No. & date 0310670262 dated 13.12.2011 Decision: It was decided to defer the case for 21.2.2013 for comments of Department of Pharmaceuticals..
Case No.B 426
M/s. Arch Pharmalabs Limited, Mumbai F.No. 01/82/050/00870/AM 09/DES III (Pt.) Meeting Date: 31.12.2012 R.A File No. 03/94/040/00393/AM 09 Adv. Lic. No. 0310481979 dated 8.8.2008 Decision: It was decided to send the request of the firm to Department of Pharmaceuticals again for their comments. Accordingly, the case was deferred for 24.01.2013.
Case No.B 427
M/s. PREGNA INTERNATIONAL LTD. F.No. 01/82/050/00941/AM 13/DES III Meeting Date: 31.12.2012 R.A File No. 03/95/040/006353/AM 12 Adv. Lic. No. 0310665072 dated 15.11.11 Decision: Commilee considered case as per agenda and in light of wrilen comments forwarded by Depl of C&PC vide their U.O.No. 46011/22/2008‐PC‐II dated 03.12.2012 and in consultalon with technical authority present in meelng, decided to ralfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ 1. Item to be exported Quanlty Intrauterine Contraceplve Devise Copper 380 AG 1 No. Raw material recommended to be imported Quanlty / kg 1. COPPER WIRE WITH SILVER CORE 0.000455 kg 2. HDPE GRANULES 0.000130 kg 3. POUCHES (PLASTIC) Net + 10% 4. COMPOUND OF LDPE RESIN & BARIUM SULPHATE 0.000560 kg 5. PVC GRANULES 0.000736 kg 6. HDPE GRANULES / NYLON RESIN MEDICAL GRADE 0.000059 kg k
POLYPROPYLENE GRANULES 0.002092 kg 2. Item to be exported Quanlty INTRA UTERINE CONTRACEPTIVE DEVICECU 200 AG 1 No. Raw material recommended to be imported Quanlty / kg 1. COPPER WIRE WITH SILVER CORE 0.000190 kg 2. HDPE GRANULES 0.000130 kg 3. POUCHES (PLASTIC) Net + 10% 4. COMPOUND OF LDPE RESIN & BARIUM SULPHATE 0.000557 kg 5. PVC GRANULES 0.000728 kg 6. HDPE GRANULES (OR NYLON RESIN) MEDICAL GRADE 0.000580 kg 7. POLYPROPYLENE GRANULES 0.002092 kg 3. Item to be exported Quanlty INTRA UTERINE CONTRACEPTIVE DEVICECU 375 1 No. Raw material recommended to be imported Quanlty / kg 1. COPPER WIRE (99.99% PURITY) 0.000416 kg 2. HDPE GRANULES 0.001385 kg 3. POUCHES (PLASTIC) Net + 10% 4. COMPOUND OF LDPE RESIN & BARIUM SULPHATE 0.0000775 kg 5. PVC GRANULES 0.000695 kg 6. HDPE GRANULES (OR NYLON RESIN) MEDICAL GRADE 0.000035 kg 4. Item to be exported Quanlty INTRA UTERINE CONTRACEPTIVE DEVICECOPPER T 380 A 1 No. Raw material recommended to be imported Quanlty / kg 1. COPPER WIRE (99.99% PURITY) 0.000204 kg 2. HDPE GRANULES 0.001202 kg 3. POUCHES (PLASTIC) Net + 10% 4. COPPER TUBE ( 99.99% PURITY) 0.000169 kg 5. POLYPROPYLENE GRANULES 0.0015543 kg
COMPOUND OF LDPE RESIN & BARIUM SULPHATE 0.000415 kg 7. PVC GRANULES 0.000658 kg 8. HDPE GRANULES (OR NYLON RESIN) MEDICAL GRADE 0.000177 kg 5. Item to be exported Quanlty INTRA UTERINE CONTRACEPTIVE DEVICE COPPER T 380 A WITH SAFE LOAD 1 No. Raw material recommended to be imported Quanlty / kg 1. COPPER WIRE (99.99% PURITY) 0.000204 kg 2. HDPE GRANULES 0.001203 kg 3. POUCHES (PLASTIC) Net + 10% 4. COPPER TUBE ( 99.99% PURITY) 0.000169 kg 5. POLYPROPYLENE GRANULES 0.001742 kg 6. COMPOUND OF LDPE RESIN & BARIUM SULPHATE 0.000415 kg 7. PVC GRANULES 0.00661 kg 8. HDPE GRANULES (OR NYLON RESIN) MEDICAL GRADE 0.000178 kg 9. POLYPROPYLENE GRANULES 0.002918 kg RA concerned may take further necessary action as per above decision of NC
Case No.B428
M/S Vivimed Labs Ltd. F.No.01/83/050/00351AM09/DESIII Meeting Date: 31.12.2012 RA F.No.09/24/040/00514/AM08 Adv.lic.No. 0910033449 dated 26.03.08 Committee decided to defer case for 24.01.2013 for comments of Department of C & PC.
Case No.B429
M/S Chiral Bioscience Ltd. F.No.01/82/050/00970/AM09/DESIII F.No.01/82/050/01618/AM11/DESIII F.No.01/82/050/01415/AM09/DESIII Meeting Date: 31.12.2012 RA F.No.09/24/040/00120/AM09 RA F.No.09/24/040/00162/AM11 RA F N 09/24/040/00005/AM11
RA F.No.09/24/040/00005/AM11 Adv.lic.No. 0910034444 dated 26.07.08 0910043817 dated 06.10.10 0910042381 dated 17.06.10 Committee decided to defer case for 24.01.2013 and again forward a copy of application to Department of Pharmaceuticals.
Case No.B430
M/S Chiral Bioscience Ltd. F.No.01/82/162/00163/AM13/DESIII Meeting Date: 31.12.2012 RA F.No.09/24/040/00102/AM10 Adv.lic.No. 0910038495 dated 08.07.2009 Committee decided to defer case for 24.01.2013 and again forward a copy of application to Department of Pharmaceuticals.
Case No.B431
M/S Chiral Bioscience Ltd. F.No.01/82/050/00113/AM11/DESIII Meeting Date: 31.12.2012 RA F.No.09/24/040/00413/AM10 Adv.lic.No. 0910040795 dated 02.02.2010 Committee decided to defer case for 24.01.2013 and again forward a copy of application to Department of Pharmaceuticals. 1
Case No.:54/41/82‐ALC4/2010
Party Name:GLAND PHARMA LIMITED Meet No/Date:27/82‐ALC4/2012 29.12.2012 Status:Case Deferred HQ File :01/82/050/01402/AM11/ RLA File :09/24/040/00289/AM11/ Lic.No/Date:0910043863 08.10.2010 Defer Date:24.01.2013 Decision :The case is under examinalon of NC. It was decided to defer for 24.1.2013
2
Case No.:3/31/82‐ALC4/2010
Party Name:EMAMI LIMITED, 29.12.2012 HQ File :01/82/050/00928/AM11/ RLA File :02/24/040/00119/AM11/ Lic.No/Date:0210149202 12.10.2010 Defer Date:24.01.2013 Decision :It was decided to give a last reminder to the firm to furnish requisite informalon within 15 days otherwise the case will be closed. The case was deferred for 24.01.2013. 3
Case No.:8/31/82‐ALC4/2010
Party Name:GLAND PHARMA LIMITED 29.12.2012 HQ File :01/82/050/00933/AM11/ RLA File :09/24/040/00290/AM11/ Lic.No/Date:0910043914 14.10.2010 Defer Date:24.01.2013 Decision : The case is under examinalon of NC. It was decided to defer for 24.1.2013 4
Case No.:48/31/82‐ALC4/2010
Party Name:GLAND PHARMA LIMITED 29.12.2012 Status:Deffered and Re‐indexed HQ File :01/82/050/00973/AM11/ RLA File :09/24/040/00297/AM11/ Lic.No/Date:0910043978 20.10.2010 Defer Date: 24.01.2013 Decision : The case is under examinalon of NC. It was decided to defer for 24.1.2013 5
Case No.:125/40/82‐ALC4/2010
Party Name:DSM ANTI‐INFECTIVES INDIA LTD 29.12.2012 HQ File :01/82/050/01324/AM11/ RLA File :22/24/040/00055/AM11/ Lic.No/Date:2210010568 25.10.2010 Defer Date:24.01.2013 Decision :It was decided to send the reminder to the firm to furnish the requisite informalon accordingly the case was deferred 24.01.2013. 6
Case No.:8/32/82‐ALC4/2010
Party Name:SAURAV CHEMICALS LTD, 29.12.2012 HQ File :01/82/050/00990/AM11/ RLA File :22/24/040/00050/AM11/ Lic No/Date:2210010581 Defer
6 HQ File :01/82/050/00990/AM11/ RLA File :22/24/040/00050/AM11/ Lic.No/Date:2210010581 28.10.2010 Defer Date:24.01.2013 Decision :It was decided to defer the case 24.01.2013 for comments for D/o Pharmaceulcals. 7
Case No.:2/34/82‐ALC4/2010
Party Name:ALEMBIC LIMITED 29.12.2012 HQ File :01/82/050/01008/AM11/ RLA File :34/24/040/00207/AM11/ Lic.No/Date:3410028544 09.11.2010 Defer Date:24.01.2013 Decision :It was decided to defer the case 24.01.2013 for comments for D/o Pharmaceulcals. 8
Case No.:30/41/82‐ALC4/2010
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 29.12.2012 HQ File :01/82/050/01378/AM11/ RLA File :05/23/040/00270/AM11/ Lic.No/Date:0510280724 30.12.2010 Defer Date:24.01.2013 Decision :It was decided to send a reminder to the firm to furnish the requisite informalon. Accordingly the case was deferred 24.01.2013. 9
Case No.:23/6/82‐ALC4/2011
Party Name:MATRIX LABORATORIES LTD 29.12.2012 HQ File :01/82/050/00141/AM12/ RLA File :09/24/040/00484/AM11/ Lic.No/Date:0910045232 27.01.2011 Defer Date:24.01.2013 Decision :It was decided to defer the case 24.01.2013 for comments for D/o Pharmaceulcals.
Case No.:15/12/82‐ALC4/2011
Party Name:ENCUBE ETHICALS PVT LTD 27.12.2012 Status:Case Approved HQ File :01/82/050/00348/AM12/ RLA File :03/94/040/00052/AM12/ Lic.No/Date:0310627904 25.04.2011 Defer Date: 27.12.2012 Decision : Committee considered case as per agenda and in light of written comments forwarded by DC(MSME) vide their U.O. No.23(10)2012/Chem/390 dated 18.12.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
10 Export product Exp. Qty. Sl.No. Import items Qty. allowed Secura Proteclve Ointment 2.47 oz 70 gm , ( Product Code No. 59431500) 100 Kg. 1. Petrolatum White Fonoline 98.789 kg Secura Proteclve Ointment 70 gm , ( Product Code No. 59431579 ) 2. Clove Bud Oil 0.300 kg 3. Vitamin A & D3 in Corn oil 0.010 kg Secura Proteclve Ointment 5.6 oz 159 gm , ( Product Code No. 59431600 ) 4. DYE D & C GREEN No 6 0.001 kg 11
Case No.:6/8/82‐ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 29.12.2012 HQ File :01/82/050/00206/AM12/ RLA File :09/24/040/00032/AM12/ Lic.No/Date:0910046590 02.05.2011 Defer Date:24.01.2013 Decision :It was decided to deferred the case for 24.01.2013 for comments of Department of Pharmaceulcals. 12
Case No.:20/14/82‐ALC4/2012
Party Name:RANBAXY LABORATORIES LTD 29.12.2012 HQ File :01/82/050/00397/AM13/ RLA File :05/24/040/00082/AM12/ Lic.No/Date:0510292925 10.06.2011 Defer Date:24.01.2013 Decision :It was decided to defer the case for 24.01.2013 for comments Department of Pharmaceulcals.
Case No.:4/16/82‐ALC4/2011
Party Name:BOSTIK INDIA PRIVATE LIMITED 29.12.2012 Status:Deffered and Re‐indexed
13 9. . 0 Re indexed HQ File :01/82/050/00462/AM12/ RLA File :07/24/040/00073/AM12/ Lic.No/Date:0710079777 13.06.2011 Defer Date:24.01.2013 Decision : It was decided to defer the case for 24.1.2013 for comments of Petrochemical division of Department of Chemicals and Petrochemicals. 14
Case No.:47/14/82‐ALC4/2011
Party Name:FDC LTD 29.12.2012 HQ File :01/82/050/00438/AM12/ RLA File :03/94/040/00152/AM12/ Lic.No/Date:0310637790 22.06.2011 Defer Date:24.01.2013 Decision :Commilee decided to defer case for 24.01.2012 for comments of Department of Pharmaceulcals. 15
Case No.:31/21/82‐ALC4/2011
Party Name:MATRIX LABORATORIES LIMITED 29.12.2012 HQ File :01/82/050/00613/AM12/ RLA File :09/24/040/00143/AM12/ Lic.No/Date:0910047366 29.06.2011 Defer Date:24.01.2013 Decision :Commilee decided to defer the case for 24.01.2012 for Dept. of Pharmaceulcals. 16
Case No.:1/35/82‐ALC4/2011
Party Name:PIRAMAL HEALTHCARE LTD.(FORMERLY NICHOLAS PIRAMAL) 29.12.2012 HQ File :01/82/050/00928/AM12/ RLA File :03/95/040/00278/AM12/ Lic.No/Date:0310642739 18.07.2011 Defer Date:24.01.2013 Decision :In the light of wrilen comments received from Department of Pharmaceulcals leler dated 27.12.2012 , it was decided to call from the firm the following informalon: 1. Copy of Master batch Formula duly cerlfied by Quality ‐Control Incharge 2. Copy of Drug Manufacturing Licence along with approved item. Accordingly the case was deferred 24 01 2013
Accordingly the case was deferred 24.01.2013. 17
Case No.:28/21/82‐ALC4/2011
Party Name:HETERO DRUGS LIMITED, 29.12.2012 HQ File :01/82/050/00610/AM12/ RLA File :09/24/040/00178/AM12/ Lic.No/Date:0910047796 21.07.2011 Defer Date:24.01.2013 Decision : It was decided to again forward a copy of applicalon to Department of Pharmaceulcals for their comments. Accordingly, the case was deferred for 24.01.2013. 18
Case No.:19/20/82‐ALC4/2011
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 29.12.2012 HQ File :01/82/050/00581/AM12/ RLA File :04/24/040/00363/AM11/ Lic.No/Date:0410126761 03.08.2011 Defer Date:24.01.2013 Decision :It was decided to remind the firm to furnish a copy of technical literature for conversion of 1 u to mg. The case was therefore deferred for 24.01.2013. 19
Case No.:13/25/82‐ALC4/2011
Party Name:EMAMI LIMITED, 29.12.2012 HQ File :01/82/050/00680/AM12/ RLA File :02/24/040/00060/AM12/ Lic.No/Date:0210163383 05.08.2011 Defer Date:24.01.2013 Decision :it was decided to remind the firm to furnish the requisite informalon immediately. Accordingly, the case was deferred for 24.01.2013. 20
Case No.:38/32/82‐ALC4/2011
Party Name:GRANULES INDIA LIMITED 29.12.2012 HQ File :01/82/050/00919/AM12/ RLA File :09/24/040/00239/AM12/ Lic.No/Date:0910048379 25.08.2011 Defer Date:24.01.2013 Decision :It was decided to defer the case for 24.01.2013 for comments of Dept. of pharmaceulcals.
ecision :It was decided to defer the case for 4.0 . 0 3 for comments of ept. of pharmaceulcals. 21
Case No.:114/42/82‐ALC4/2011
Party Name:ANUS LABORATORIES LTD., 29.12.2012 HQ File :01/82/050/01149/AM12/ RLA File :09/24/040/00306/AM11/ Lic.No/Date:0910049026 23.09.2011 Defer Date:24.01.2013 Decision :It was decided to give a final reminder to the firm to furnish requisite informalon within 15 days failing which the case would be closed. Accordingly the case was deferred for 24.01.2013. 22
Case No.:90/42/82‐ALC4/2011
Party Name:VIVIMED LABS LIMITED 29.12.2012 Status:Case Rejected HQ File :01/82/050/01125/AM12/ RLA File :09/24/040/00318/AM12/ Lic.No/Date:0910049191 30.09.2011 Defer Date: 24.01.2013 Decision : The last reminder was given to the firm to send the reply within 15 days but, the same has not been received lll date. Hence the case is closed. 23
Case No.:113/42/82‐ALC4/2011
Party Name:NEULAND LABORATORIES LTD 29.12.2012 Status:Deffered and Re‐indexed HQ File :01/82/050/01148/AM12/ RLA File :09/24/040/00310/AM12/ Lic.No/Date:0910049392 19.10.2011 Defer Date:27.12.2012 Decision : It was decided to defer the case for 24.01.2013 for comments of Department of Pharmaceulcals. 24
Case No.:25/41/82‐ALC4/2011
Party Name:CADILA HEALTHCARE LTD., 29.12.2012 Status:Deffered and Re‐indexed HQ File :01/82/050/01026/AM12/ RLA File :08/24/040/00179/AM12/ Lic.No/Date:0810105257 08.11.2011 Defer Date:24.01.2013 Decision : It was decided to again forward a copy of applicalon to Department of Pharmaceulcals for their comments. Accordingly, the case was deferred for 24.01.2013.
25
Case No.:70/42/82‐ALC4/2011
Party Name:ORGANICA AROMATICS PVT LTD 29.12.2012 Status:Deffered and Re‐indexed HQ File :01/82/050/01105/AM12/ RLA File :07/24/040/00314/AM12/ Lic.No/Date:0710084171 23.11.2011 Defer Date: 24.01.2013 Decision :The commilee decided to defer the case for 24.01.2013 for comments of Depl. of Pharmaceulcals. 26
Case No.:7/45/82‐ALC4/2011
Party Name:SANO MEDICAL KITS PVT. LTD., 29.12.2012 Status:Deffered and Re‐indexed HQ File :01/82/050/01184/AM12/ RLA File :04/24/040/00244/AM12/ Lic.No/Date:0410131205 01.12.2011 Defer Date: 24.01.2013 Decision : It was decided to send a final reminder to the firm to furnish the requisite informalon with in 15 days failing which the case would be closed. Accordingly the case was deferred for 24.01.2013. 27
Case No.:6/38/82‐ALC4/2011
Party Name:INDO GERMAN ALKALOIDS 29.12.2012 Status:Deffered and Re‐indexed HQ File :01/82/050/00992/AM12/ RLA File :03/94/040/00776/AM12/ Lic.No/Date:0310669794 09.12.2011 Defer Date: 24.01.2013 Decision :It was decided to remind the firm to furnish the informalon sought vide minutes of earlier meelng within 15 days failing when the case would be closed Accordingly, the case was deferred for 24.01.2013 28
Case No.:23/3/82‐ALC4/2012
Party Name:PORUS LABORATORIES PVT LTD. 29.12.2012 Status:Case Approved HQ File :01/82/050/00027/AM13/ RLA File :09/24/040/00434/AM12/ Lic.No/Date:0910050371 22.12.2011 Defer Date: 27.12.2012 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their F.No. No.46011/77/2012PCII dated 18.12.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed
C884083 ‐ Capped 0.09 IV BIFUNCTIONAL PPO 1 Kg. 1. MX 90 / SA90‐100‐0‐50ST 1.53 kg 2. METHACRYLIC ANHYDRIDE / MAAH 0.32 kg 3. 4‐DIMETHYL AMINO PYRIDINE 0.02 kg 29
Case No.:79/4/82‐ALC4/2012
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 29.12.2012 Status:Case Approved HQ File :01/82/050/00159/AM13/ RLA File :05/23/040/00364/AM12/ Lic.No/Date:0510312169 22.12.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their F.No. No.35011/422/2012PI (Norms) dated 21.12.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Risedronate Sodium 5 mg Tablets 1000 Nos 1. Risedronate Sodium 5.1 gm Risedronate Sodium 30 mg Tablets 1000 Nos 2. Risedronate Sodium 30.6 gm RA may take appropriate aclon as per the decision of Norms Commilee. 30
Case No.:1/47/82‐ALC4/2011
Party Name:BROOKS LABORATORIES LTD., 29.12.2012 Status:Deffered and Re‐indexed HQ File :01/82/050/01301/AM12/ RLA File :22/24/040/00067/AM12/ Lic.No/Date:2210012351 23.12.2011 Defer Date: 24.01.2013 Decision :It was decided to remind the firm to furnish the requisite informalon immediately , accordingly the case was deferred for 24.01.2013 for comments of Depl. of Pharmaceulcals.
31
Case No.:2/47/82‐ALC4/2011
Party Name:BROOKS LABORATORIES LTD., 29.12.2012 Status:Deffered and Re‐indexed HQ File :01/82/050/01302/AM12/ RLA File :22/24/040/00066/AM12/ Lic.No/Date:2210012352 23.12.2011 Defer Date: 24.01.2013 Decision :It was decided to remind the firm to furnish the requisite informalon within 15 days. Accordingly, the case was deferred for 24.01.2013. 32
Case No.:3/41/82‐ALC4/2011
Party Name:RUSAN PHARMA LTD. 29.12.2012 Status:Deffered and Re‐indexed HQ File :01/82/050/01004/AM12/ RLA File :03/95/040/00803/AM12/ Lic.No/Date:0310673724 30.12.2011 Defer Date: 24.01.2013 Decision : It was decided to remind the firm to furnish the requisite informalon immediately. accordingly the was deferred for 24.01.2013 33
Case No.:13/3/82‐ALC4/2012
Party Name:INCHEM LABORATORIES PRIVATE LIMITED 29.12.2012 Status:Deffered and Re‐indexed HQ File :01/82/050/00017/AM13/ RLA File :09/24/040/00467/AM12/ Lic.No/Date:0910050600 03.01.2012 Defer Date:24.01.2013 Decision : It was decided to remind the firm to furnish the requisite informalon immediately. accordingly the was deferred for 24.01.2013 34
Case No.:16/29/85‐ALC3/2011
Party Name:S.R.S.PHARMACEUTICALS PVT. LTD. 29.12.2012 Status:Deffered and Re‐ indexed HQ File :01/85/050/00173/AM12/ RLA File :03/95/040/00831/AM12/ Lic.No/Date:0310674968 05.01.2012 Defer Date: 24.01.2013 Decision :The commilee decided to defer the case for 24.01.2013 for comments of Depl. of Pharmaceulcals.
Case No.:23/51/82‐ALC4/2011
Party Name:IND‐SWIFT LABORATORIES LTD., 29.12.2012 Status:Case Approved HQ File 01/82/050/01416/AM12/ RLA File 22/24/040/00084/AM12/ Lic No/Date 2210012473 Defer Date
35 HQ File :01/82/050/01416/AM12/ RLA File :22/24/040/00084/AM12/ Lic.No/Date:2210012473 25.01.2012 Defer Date: 27.12.2012 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their F.No. No.35011/535/2012PI (Norms) dated 27.12.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Nitazoxanide 1 kg 1. Methylene Chloride 3.17 2. 2‐(Acetyloxy)‐Benzoic Acid (Aspirin) 0.916 3. N,N Dimethyl Formamide 0.069 4. Thionyl Chloride 0.92 5. 2‐Amino‐5‐Nitro Thiazole 0.59 6. Triethylamine 0.1288 7. Acetone 2.00 36
Case No.:56/3/82‐ALC4/2012
Party Name:VINDHYA PHARMA (INDIA)PVT LTD. 29.12.2012 Status:Deffered and Re‐indexed HQ File :01/82/050/00060/AM13/ RLA File :09/24/040/00494/AM12/ Lic.No/Date:0910051044 31.01.2012 Defer Date: 24.01.2013 Decision :The commilee decided to defer the case for 24.01.2013 for comments of Depl. of pharmaceulcals. 37
Case No.:5/3/82‐ALC4/2012
Party Name:RA CHEM PHARMA LIMITED 29.12.2012 Status:Deffered and Re‐indexed HQ File :01/82/050/00009/AM13/ RLA File :09/24/040/00519/AM12/ Lic.No/Date:0910051057 01.02.2012 Defer Date: 24.01.2013 fi f f f f
Decision :It was decided to remind the firm to furnish requisite informalon within 15 days. Accordingly, the case was deferred for 24.01.2013. 38
Case No.:37/3/82‐ALC4/2012
Party Name:ORTIN LABORATORIES LTD. 29.12.2012 Status:Case Approved HQ File :01/82/050/00041/AM13/ RLA File :09/24/040/00492/AM12/ Lic.No/Date:0910051112 03.02.2012 Defer Date: 27.12.2012 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their F.No. No.35011/571/2012PI (Norms) dated 26.12.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Amino Carbinol 1 kg 1. 4‐CHLORO‐2‐TRIFLUORO ACETYL‐ ANILINE HYDROCHLORIDE HYDRATE 1.30 2. CYCLOPROPYL ACETYLENE 0.395 3. CITRIC ACID 0.61 4. LITHIUM METAL 0.257 5. TETRAHYDROFURAN 5.32 6. N HEXANE(EXXSOL HEXANE) 2.25 7. N‐BUTYL CHLORIDE 1.21 8. TRIFLUORO ETHANOL 0.500 39
Case No.:4/3/82‐ALC4/2012
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 29.12.2012 Status:Deffered and Re‐indexed HQ File :01/82/050/00008/AM13/ RLA File :09/24/040/00509/AM12/ Lic.No/Date:0910051114 03.02.2012 Defer Date:24.01.2013
Decision : It was decided to remind the firm to furnish the technical details as per Appendix 33. Accordingly, the case was deferred for 24.01.2013. 40
Case No.:29/3/82‐ALC4/2012
Party Name:PORUS LABORATORIES PVT LTD. 29.12.2012 Status:Case Approved HQ File :01/82/050/00033/AM13/ RLA File :09/24/040/00521/AM12/ Lic.No/Date:0910051178 09.02.2012 Defer Date: 27.12.2012 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their F.No. No.46011/77/2012PCII dated 18.12.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed C884083 ‐ Capped 0.09 IV BIFUNCTIONAL PPO 1 Kg. 1. MX 90 / SA90‐100‐0‐50ST 1.53 kg 2. METHACRYLIC ANHYDRIDE / MAAH 0.32 kg 3. 4‐DIMETHYL AMINO PYRIDINE 0.02 kg 41
Case No.:43/3/82‐ALC4/2012
Party Name:NECTAR LIFESCIENCES LIMITED, 29.12.2012 Status:Case Approved HQ File :01/82/050/00047/AM13/ RLA File :22/24/040/00087/AM12/ Lic.No/Date:2210012518 10.02.2012 Defer Date: 27.12.2012 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their F.No. No.35011/544/2012PI (Norms) dated 27.12.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Celazidime for Injeclon. "The export product shall account for 55 1 Kg. 1. Celazidime Pentahydrate Sterile (Un‐Buffered) 0.928 2. Sodium Carbonate 0.082
Nos. Aluminium Bolle Anodized with Tear of alu & Chlorobutyl plug" 3. Aluminium Bolle Anodized with Tear off alu cap & chlorobutyl plug Relevant , As per packing policy 42
Case No.:18/8/82‐ALC4/2012
Party Name:SYMBIOTEC PHARMALAB LTD., 29.12.2012 Status:Case Approved HQ File :01/82/050/00210/AM13/ RLA File :56/24/040/00001/AM12/ Lic.No/Date:5610000024 13.02.2012 Defer Date: 27.12.2012 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their F.No. No.35011/568/2012PI (Norms) dated 26.12.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Desoximetasone USP ORGANIC CHEMICALS 1 Kg. 1. 4 TR (9 beta 11 beta epoxy 21‐ hydroxy pregna‐1,4,16 triene‐3,20‐dione 21‐ acetate ) 2.03 43
Case No.:55/4/82‐ALC4/2012
Party Name:MANGALAM DRUGS & ORGANICS LIMITED 29.12.2012 HQ File :01/82/050/00135/AM13/ RLA File :03/95/040/00886/AM12/ Lic.No/Date:0310681867 14.02.2012 Defer Date:24.01.2013 Decision : In the light of wrilen comments received from Department of Pharmaceulcals leler dated 27.12.2012 , it was decided to call technical details as per Appendix 33 from the firm. Accordingly, the case was deferred for 24.01.2013.
44
Case No.:49/1/82‐ALC4/2012
Party Name:BLUE CIRCLE ORGANICS PVT. LTD. 29.12.2012 HQ File :01/82/050/01491/AM12/ RLA File :03/94/040/00757/AM12/ Lic.No/Date:0310682083 15.02.2012 Defer Date:24.01.2013 Decision : The commilee decided to defer the case for 24.01.2013 for comments of Department of Chemicals and Petrochemicals. 45
Case No.:20/4/82‐ALC4/2012
Party Name:ARCH PHARMALABS LTD 29.12.2012 HQ File :01/82/050/00100/AM13/ RLA File :03/94/040/01027/AM12/ Lic.No/Date:0310683207 23.02.2012 Defer Date:24.01.2013 Decision :It was decided to remind the firm to furnish the requisite informalon within 15 days. Accordingly, the case was deferred for 24.01.2013. 46
Case No.:27/4/82‐ALC4/2012
29.12.2012 Status:Deffered and Re‐indexed HQ File :01/82/050/00107/AM13/ RLA File :03/94/040/01049/AM12/ Lic.No/Date:0310683243 24.02.2012 Defer Date:27.12.2012 Decision : It was decided to remind the firm to furnish the requisite informalon within 15 days. Accordingly, the case was deferred for 24.01.2013. 47
Case No.:66/4/82‐ALC4/2012
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 29.12.2012 HQ File :01/82/050/00146/AM13/ RLA File :07/24/040/00479/AM12/ Lic.No/Date:0710086622 28.02.2012 Defer Date:24.01.2013 Decision : The commilee decided to defer the case for 24.01.2013 for comments of Depl. of pharmaceulcals.
48
Case No.:21/4/82‐ALC4/2012
29.12.2012 HQ File :01/82/050/00101/AM13/ RLA File :03/94/040/01059/AM12/ Lic.No/Date:0310684071 29.02.2012 Defer Date:24.01.2013 Decision :It wad decided to remind the firm to furnish the requisite informalon withing 15 days. Accordingly, the case was deferred for 24.01.2012 49
Case No.:22/4/82‐ALC4/2012
29.12.2012 HQ File :01/82/050/00102/AM13/ RLA File :03/94/040/01067/AM12/ Lic.No/Date:0310684092 29.02.2012 Defer Date:24.01.2013 Decision : The commilee decided to defer the case for 24.01.2013 for comments of Depl. of pharmaceulcals. 50
Case No.:31/3/82‐ALC4/2012
29.12.2012 HQ File :01/82/050/00035/AM13/ RLA File :03/94/040/01052/AM12/ Lic.No/Date:0310684086 29.02.2012 Defer Date:24.01.2013 Decision :It was decided to remind the firm to furnish the requisite informalon within 15 days. Accordingly, the case was deferred for 24.01.2012 51
Case No.:32/3/82‐ALC4/2012
29.12.2012 HQ File :01/82/050/00036/AM13/ RLA File :03/94/040/01066/AM12/ Lic.No/Date:0310684076 29.02.2012 Defer Date:24.01.2013 Decision :It wad decided to remind the firm to furnish the requisite informalon immediately. Accordingly, the case was deferred for 24.01.2012. 52
Case No.:24/4/82‐ALC4/2012
Party Name:ENCUBE ETHICALS PVT LTD 29.12.2012 Status:Case Approved HQ File :01/82/050/00104/AM13/ RLA File :03/94/040/01071/AM12/ Lic.No/Date:0310684364 01.03.2012 Defer Date: 27.12.2012
Decision : Committee considered case as per agenda and in light of written comments forwarded by DC(MSME) vide their U.O. No.23(10)2012/Chem/381 dated 27.11.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Medichoice Heatrub Ointment 100 Gm. 100,000 Nos. 1. Chlorophyll Oil Soluble Copper (Copper Chlorophyll 15% L‐OS ) 10.20 kg 2. Birch Oil Sweet 16.32 kg 3. Cajuput Oil (Cajeput Oil) 12.903 kg 4. Eucalyptus Oil 107.10 kg 5. Medichoice Heatrub Ointment 100 Gm. Aluminium Tube / Cartridge As per packing policy 53
Case No.:19/3/82‐ALC4/2012
29.12.2012 HQ File :01/82/050/00023/AM13/ RLA File :03/94/040/01095/AM12/ Lic.No/Date:0310684494 02.03.2012 Defer Date:24.01.2013 Decision :It was decided to remind the firm to furnish the requisite informalon withing 15 days. Accordingly, the case was deferred for 24.01.2012 54
Case No.:19/4/82‐ALC4/2012
29.12.2012 HQ File :01/82/050/00099/AM13/ RLA File :03/94/040/01081/AM12/ Lic.No/Date:0310684500 02.03.2012 Defer Date:24.01.2013 Decision :It was decided to remind the firm to furnish the requisite informalon within 15 days. Accordingly, the case was deferred for 24.01.2013
55
Case No.:23/4/82‐ALC4/2012
29.12.2012 HQ File :01/82/050/00103/AM13/ RLA File :03/94/040/01085/AM12/ Lic.No/Date:0310684507 02.03.2012 Defer Date:24.01.2013 Decision :It was decided to remind the firm to furnish the requisite informalon withing 15 days. Accordingly, the case was deferred for 24.01.2013 56
Case No.:25/4/82‐ALC4/2012
29.12.2012 HQ File :01/82/050/00105/AM13/ RLA File :03/94/040/01078/AM12/ Lic.No/Date:0310684488 02.03.2012 Defer Date:24.01.2013 Decision :It was decided to remind the firm to furnish the requisite informalon withing 15 days. Accordingly, the case was deferred for 24.01.2013 57
Case No.:74/4/82‐ALC4/2012
Party Name:PORUS LABORATORIES PVT LTD. 29.12.2012 Status:Case Approved HQ File :01/82/050/00154/AM13/ RLA File :09/24/040/00597/AM12/ Lic.No/Date:0910051589 02.03.2012 Defer Date: 27.12.2012 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their F.No. No.46011/77/2012PCII dated 18.12.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed C884083 ‐ Capped 0.09 IV BIFUNCTIONAL PPO 1 Kg. 1. MX 90 / SA90‐100‐0‐50ST 1.53 kg 2. METHACRYLIC ANHYDRIDE / MAAH 0.32 kg 3. 4‐DIMETHYL AMINO PYRIDINE 0.02 kg RA concerned may take further necessary action as per above decision of NC
58
Case No.:16/11/82‐ALC4/2012
Party Name:HETERO LABS LIMITED 29.12.2012 Status:Case Approved HQ File :01/82/050/00283/AM13/ RLA File :09/24/040/00609/AM12/ Lic.No/Date:0910051695 12.03.2012 Defer Date: 27.12.2012 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their F.No. No.35011/599/2012PI (Norms) dated 26.12.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg S‐4‐BOC‐piperazine‐2‐ carboxy tert.Butyl amide 1 kg 1. 2‐Cyano pyrazine 1.57 2. Tert.Butanol 1.47 3. Triethyl amine 0.47 4. L‐Phenyl alanine 2.36 5. n‐Hexane 2.82 6. Di‐tert.Butyl dicarbonate (DIBOC) 0.63 59
Case No.:2/52/82‐ALC4/2011
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 29.12.2012 Status:Case Approved HQ File :01/82/050/01437/AM12/ RLA File :03/95/040/00859/AM12/ Lic.No/Date:0310686264 14.03.2012 Defer Date: 27.12.2012 Decision :It was seen that this case has already been approved in 52/82 dated 27.3.2012. Therefore, the case was withdrawn.
Case No.:21/8/82‐ALC4/2012
Party Name:ALEMBIC PHARMACEUTICALS LTD 29 12 2012
60 29.12.2012 HQ File :01/82/050/00213/AM13/ RLA File :34/24/040/00289/AM12/ Lic.No/Date:3410033599 19.03.2012 Defer Date:24.01.2013 Decision :It was decided to defer the case for 24.1.2013 for comments of Department of Pharmaceulcals. 61
Case No.:34/16/82‐ALC4/2012
Party Name:MYLAN LABORATORIES LIMITED 29.12.2012 HQ File :01/82/050/00470/AM13/ RLA File :09/24/040/00658/AM12/ Lic.No/Date:0910052048 04.04.2012 Defer Date:24.01.2013 62
Case No.:36/11/82‐ALC4/2012
Party Name:LAKE CHEMICALS PRIVATE LIMITED 29.12.2012 HQ File :01/82/050/00303/AM13/ RLA File :07/24/040/00004/AM13/ Lic.No/Date:0710087698 16.04.2012 Defer Date:24.01.2013 63
Case No.:18/18/82‐ALC4/2012
29.12.2012 HQ File :01/82/050/00513/AM13/ RLA File :09/24/040/00034/AM13/ Lic.No/Date:0910052325 25.04.2012 Defer Date:24.01.2013 64
Case No.:9/18/82‐ALC4/2012
29.12.2012 HQ File :01/82/050/00504/AM13/ RLA File :09/24/040/00032/AM13/ Lic.No/Date:0910052326 25.04.2012 Defer Date:24.01.2013
65
Case No.:21/18/82‐ALC4/2012
29.12.2012 Status:Case Approved HQ File :01/82/050/00516/AM13/ RLA File :09/24/040/00095/AM13/ Lic.No/Date:0910052779 25.05.2012 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their F.No. No.35011/599/2012PI (Norms) dated 26.12.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg QUETIAPINE HEMIFUMARATE 1 kg 1. Thiophenol 0.553 2. Phenyl chloroformate 0.64 3. Polyphosphoric acid 3.78 4. 2‐Chloro ethoxy ethanol 0.36 5. Toluene 8.48 6. Acetone 1.05 7. n‐Hexane 0.81 8. Methanol 1.13 9. Isopropyl alcohol 1.36 66
Case No.:23/18/82‐ALC4/2012
29.12.2012 Status:Case Approved HQ File :01/82/050/00518/AM13/ RLA File :09/24/040/00116/AM13/ Lic.No/Date:0910052859 01.06.2012 Defer Date: 27.12.2012
Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their F.No. No.35011/599/2012PI (Norms) dated 26.12.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg 3‐[(4‐Fluorophenyl)‐1‐ (1‐methylethyl)‐1H‐indol ‐2‐yl]‐2‐propenal 1 kg 1. N‐Methyl ‐N‐ phenyl ‐3‐ amino acrolein 0.708 2. 3‐(4‐Fluorophenyl )‐1‐(1‐ methylethyl)‐1H‐indole 1.114 3. Acetonitrile 1.94 67
Case No.:24/18/82‐ALC4/2012
Party Name:HETERO DRUGS LIMITED, 29.12.2012 HQ File :01/82/050/00519/AM13/ RLA File :09/24/040/00111/AM13/ Lic.No/Date:0910052860 01.06.2012 Defer Date:24.01.2013 68
Case No.:19/14/82‐ALC4/2012
Party Name:NEULAND LABORATORIES LTD 29.12.2012 Status:Deffered and Re‐indexed HQ File :01/82/050/00396/AM13/ RLA File :09/24/040/00101/AM13/ Lic.No/Date:0910052939 08.06.2012 Defer Date:24.01.2013 Decision : It was decided to defer the case for 24.1.2013 for comments of Department of Pharmaceulcals. 69
Case No.:84/18/82‐ALC4/2012
Party Name:STERICON PHARMA PVT.LTD., 29.12.2012 HQ File :01/82/050/00579/AM13/ RLA File :07/24/040/00108/AM13/ Lic.No/Date:0710088798 Defer
Q / / / / / / / / / / / 13.06.2012 Date:24.01.2013 Decision :It was decided to defer the case for 24.1.2013 for comments of Department of Biotechnology. 70
Case No.:2/23/82‐ALC4/2012
Party Name:IND‐SWIFT LABORATORIES LTD., 29.12.2012 HQ File :01/82/050/00802/AM13/ RLA File :22/24/040/00012/AM13/ Lic.No/Date:2210013015 14.06.2012 Defer Date:24.01.2013 71
Case No.:87/18/82‐ALC4/2012
Party Name:BILCARE LIMITED 29.12.2012 HQ File :01/82/050/00582/AM13/ RLA File :31/83/040/00051/AM13/ Lic.No/Date:3110054688 15.06.2012 Defer Date:24.01.2013 Decision :It was decided to call the firm for personal hearing on 24.1.2013 with all their files which are pending in DGFT. It was also decided to seek clarificalon from the firm whether they have taken permission from the Drug Controller of India. The firm is also requested to bring with them the complete process of manufacturing. The case was deferred for 24.1.2013 72
Case No.:14/18/82‐ALC4/2012
Party Name:MYLAN LABORATORIES LIMITED 29.12.2012 HQ File :01/82/050/00509/AM13/ RLA File :09/24/040/00604/AM12/ Lic.No/Date:0910053078 18.06.2012 Defer Date:24.01.2013 73
Case No.:40/18/82‐ALC4/2012
Party Name:MYLAN LABORATORIES LIMITED 29.12.2012 HQ File :01/82/050/00535/AM13/ RLA File :09/24/040/00399/AM12/ Lic.No/Date:0910053076 18.06.2012 Defer Date:24.01.2013
74
Case No.:44/18/82‐ALC4/2012
Party Name:MYLAN LABORATORIES LIMITED 29.12.2012 HQ File :01/82/050/00539/AM13/ RLA File :09/24/040/00666/AM12/ Lic.No/Date:0910053075 18.06.2012 Defer Date:24.01.2013 75
Case No.:86/18/82‐ALC4/2012
Party Name:ADCOCK INGRAM LTD, 29.12.2012 HQ File :01/82/050/00581/AM13/ RLA File :07/24/040/00115/AM13/ Lic.No/Date:0710089034 19.06.2012 Defer Date:24.01.2013 76
Case No.:50/18/82‐ALC4/2012
Party Name:AMI LIFESCIENCES P LTD 29.12.2012 HQ File :01/82/050/00545/AM13/ RLA File :34/24/040/00072/AM13/ Lic.No/Date:3410034467 22.06.2012 Defer Date:24.01.2013 77
Case No.:4/18/82‐ALC4/2012
Party Name:MYLAN LABORATORIES LIMITED 29.12.2012 HQ File :01/82/050/00499/AM13/ RLA File :09/24/040/00110/AM13/ Lic.No/Date:0910053114 25.06.2012 Defer Date:24.01.2013
Case No.:108/18/82‐ALC4/2012
Party Name:FRESENIUS KABI ONCOLOGY LIMITED
78 / / / y / / / 29.12.2012 HQ File :01/82/050/00603/AM13/ RLA File :05/23/040/00471/AM12/ Lic.No/Date:0510328338 27.06.2012 Defer Date:24.01.2013 79
Case No.:111/18/82‐ALC4/2012
Party Name:JAGSONPAL PHARMACEUTICALS LTD. 29.12.2012 HQ File :01/82/050/00606/AM13/ RLA File :05/23/040/00075/AM13/ Lic.No/Date:0510328346 27.06.2012 Defer Date:24.01.2013 80
Case No.:20/18/82‐ALC4/2012
29.12.2012 HQ File :01/82/050/00515/AM13/ RLA File :09/24/040/00146/AM13/ Lic.No/Date:0910053163 03.07.2012 Defer Date:24.01.2013 81
Case No.:45/18/82‐ALC4/2012
29.12.2012 HQ File :01/82/050/00540/AM13/ RLA File :09/24/040/00152/AM13/ Lic.No/Date:0910053161 03.07.2012 Defer Date:24.01.2013 82
Case No.:74/18/82‐ALC4/2012
29.12.2012 Status:Case Approved HQ File :01/82/050/00569/AM13/ RLA File :09/24/040/00147/AM13/ Lic.No/Date:0910053162 03.07.2012 Defer Date: 27.12.2012
Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their F.No. No.35011/599/2012PI (Norms) dated 26.12.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg TORSEMIDE 1 kg 1. 4‐(3‐Methylphenyl)amino]‐3‐ pyridine sulfonamide 1.386 2. Isopropyl isocyanate 1.73 83
Case No.:31/18/82‐ALC4/2012
Party Name:SRIAM LABS PRIVATE LIMITED 29.12.2012 HQ File :01/82/050/00526/AM13/ RLA File :09/24/040/00143/AM13/ Lic.No/Date:0910053188 04.07.2012 Defer Date:24.01.2013 Decision : It was decided to defer the case for 24.1.2013 for comments of Department of Pharmaceulcals. 84
Case No.:28/18/82‐ALC4/2012
Party Name:DIVIS LABORATORIES LTD., 29.12.2012 Status:Case Approved HQ File :01/82/050/00523/AM13/ RLA File :09/24/040/00165/AM13/ Lic.No/Date:0910053195 05.07.2012 Defer Date: 27.12.2012 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their F.No. No.35011/615/2012PI (Norms) dated 27.12.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg LEVETIRACETAM 1 kg 1. 2‐(2‐Oxo‐Pyrrolidin‐1‐yl) butanoic acid 1.84 2 D(+)Alphaphenyletheylamine 0 43
D(+)Alphaphenyletheylamine 0.43 3. Ethyl Chloro Formate 1.13 4. Isopropyl Alcohol 1.39 85
Case No.:15/18/82‐ALC4/2012
Party Name:ASCENT FINECHEM PVT. LTD., 29.12.2012 HQ File :01/82/050/00510/AM13/ RLA File :08/24/040/00112/AM13/ Lic.No/Date:0810113196 09.07.2012 Defer Date:24.01.2013 Decision : It was decided to call from the firm to end use of export product and defer the case for 24.1.2013 for comments of Department of Chemicals and Petrochemicals. 86
Case No.:68/18/82‐ALC4/2012
Party Name:SMILAX LABORATORIES LIMITED 29.12.2012 Status:Deffered and Re‐ indexed HQ File :01/82/050/00563/AM13/ RLA File :09/24/040/00148/AM13/ Lic.No/Date:0910053214 09.07.2012 Defer Date:24.01.2013 Decision : Committee decided to defer case for 24.01.2013 for comments of Dept. of Pharmaceuticals 87
Case No.:79/18/82‐ALC4/2012
Party Name:KUDOS CHEMIE LTD., 29.12.2012 Status:Case Approved HQ File :01/82/050/00574/AM13/ RLA File :22/24/040/00016/AM13/ Lic.No/Date:2210013078 09.07.2012 Defer Date: 27.12.2012: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their F.No. No.35011/616/2012PI (Norms) dated 27.12.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed
kg/kg ADENINE 1 kg 1. MALONONITRILE 0.95 88
Case No.:81/18/82‐ALC4/2012
29.12.2012 Status:Case Approved HQ File :01/82/050/00576/AM13/ RLA File :22/24/040/00015/AM13/ Lic.No/Date:2210013077 09.07.2012 Defer Date: 27.12.2012 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their F.No. No.35011/616/2012PI (Norms) dated 27.12.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg ADENINE 1 kg 1. MALONONITRILE 0.95 89
Case No.:60/18/82‐ALC4/2012
Party Name:PIRAMAL HEALTHCARE LTD.(FORMERLY NICHOLAS PIRAMAL) 29.12.2012 Status:Case Approved HQ File :01/82/050/00555/AM13/ RLA File :03/95/040/00225/AM13/ Lic.No/Date:0310701398 10.07.2012 Defer Date: 27.12.2012 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their F.No. No.35011/539/2012PI (Norms) dated 26.12.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items For export of 1 No. Tablets
50 mg 100 mg Cilostazol Tablets 50 m.g. and 100 m.g. 1 kg 1. Cilostazol 51.0 102.0 2. Microcrystalline celluose NFAvicelPH102 20.0 40.0 3. Povidone USP (PVP K 30) 3.0 6.0 4. Corn starch NF 16.75 33.50 5. Crospovidone NF 5.0 10.0 6. Bolle HDPE 60CC White 33/400 NECK(DPG) Relevant , as per packing policy 7. Plaslc CR Closur PP 33‐ 400/FS M1(GREEN) Relevant , as per packing policy 90
Case No.:61/18/82‐ALC4/2012
Party Name:PIRAMAL HEALTHCARE LTD.(FORMERLY NICHOLAS PIRAMAL) 29.12.2012 HQ File :01/82/050/00556/AM13/ RLA File :03/95/040/00226/AM13/ Lic.No/Date:0310701402 10.07.2012 Defer Date:24.01.2013 Decision : In the light of wrilen comments received from Department of Pharmaceulcals leler dated 27.12.2012 , it was decided to call from the firm a copy of Master Batch formula duly cerlfied by Quality ‐ Control Incharge. Accordingly, the case was deferred for 24.01.2013. 91
Case No.:62/18/82‐ALC4/2012
Party Name:PIRAMAL HEALTHCARE LTD.(FORMERLY NICHOLAS PIRAMAL) 29.12.2012 HQ File :01/82/050/00557/AM13/ RLA File :03/95/040/00227/AM13/ Lic.No/Date:0310701405 10.07.2012 Defer Date:24.01.2013 Decision : It was decided to defer the case for 24.1.2013 for comments of Department of Pharmaceulcals.
92
Case No.:82/18/82‐ALC4/2012
29.12.2012 Status:Case Approved HQ File :01/82/050/00577/AM13/ RLA File :22/24/040/00017/AM13/ Lic.No/Date:2210013080 10.07.2012 Defer Date: 27.12.2012 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their F.No. No.35011/616/2012PI (Norms) dated 27.12.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg ADENINE 1 kg 1. MALONONITRILE 0.95 93
Case No.:85/18/82‐ALC4/2012
29.12.2012 Status:Case Approved HQ File :01/82/050/00580/AM13/ RLA File :22/24/040/00018/AM13/ Lic.No/Date:2210013079 10.07.2012 Defer Date: 27.12.2012 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their F.No. No.35011/616/2012PI (Norms) dated 27.12.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg ADENINE 1 kg 1. MALONONITRILE 0.95
94
Case No.:91/18/82‐ALC4/2012
29.12.2012 Status:Case Approved HQ File :01/82/050/00586/AM13/ RLA File :22/24/040/00020/AM13/ Lic.No/Date:2210013092 12.07.2012 Defer Date: 27.12.2012 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their F.No. No.35011/616/2012PI (Norms) dated 27.12.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg ADENINE 1 kg 1. MALONONITRILE 0.95 95
Case No.:22/14/82‐ALC4/2012
Party Name:EMCURE PHARMACEUTICALS LTD. 29.12.2012 HQ File :01/82/050/00399/AM13/ RLA File :31/83/040/00070/AM13/ Lic.No/Date:3110054967 13.07.2012 Defer Date:24.01.2013 96
Case No.:53/18/82‐ALC4/2012
Party Name:ENCUBE ETHICALS PVT LTD 29.12.2012 HQ File :01/82/050/00548/AM13/ RLA File :03/94/040/00304/AM13/ Lic.No/Date:0310702050 17.07.2012 Defer Date:24.01.2013
Case No.:104/18/82‐ALC4/2012
Party Name:NECTAR LIFESCIENCES LIMITED, 29.12.2012
97 HQ File :01/82/050/00599/AM13/ RLA File :22/24/040/00014/AM13/ Lic.No/Date:2210013107 17.07.2012 Defer Date:24.01.2013 98
Case No.:5/18/82‐ALC4/2012
Party Name:SWISS PARENTERALS PVT.LTD. 29.12.2012 HQ File :01/82/050/00500/AM13/ RLA File :08/24/040/00122/AM13/ Lic.No/Date:0810113430 17.07.2012 Defer Date:24.01.2013 99
Case No.:51/18/82‐ALC4/2012
Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 29.12.2012 HQ File :01/82/050/00546/AM13/ RLA File :04/24/040/00074/AM13/ Lic.No/Date:0410138168 17.07.2012 Defer Date:24.01.2013 100
Case No.:98/18/82‐ALC4/2012
Party Name:NECTAR LIFESCIENCES LIMITED, 29.12.2012 HQ File :01/82/050/00593/AM13/ RLA File :22/21/040/00063/AM13/ Lic.No/Date:2210013106 17.07.2012 Defer Date:24.01.2013 Decision : It was decided to defer the case for 24.1.2013 for comments of Department of Pharmaceulcals. 101
Case No.:41/18/82‐ALC4/2012
Party Name:CADILA HEALTHCARE LTD., 29.12.2012 HQ File :01/82/050/00536/AM13/ RLA File :08/24/040/00131/AM13/ Lic.No/Date:0810113485 18.07.2012 Defer Date:24.01.2013
102
Case No.:47/18/82‐ALC4/2012
Party Name:ALEMBIC PHARMACEUTICALS LTD 29.12.2012 HQ File :01/82/050/00542/AM13/ RLA File :34/24/040/00103/AM13/ Lic.No/Date:3410034667 18.07.2012 Defer Date:24.01.2013 103
Case No.:70/18/82‐ALC4/2012
Party Name:INGA LABORATORIES PVT LIMITED 29.12.2012 HQ File :01/82/050/00565/AM13/ RLA File :03/94/040/00284/AM13/ Lic.No/Date:0310702227 18.07.2012 Defer Date:24.01.2013 104
Case No.:23/21/82‐ALC4/2012
Party Name:ASTRIX LABORATORIES LTD., 29.12.2012 HQ File :01/82/050/00653/AM13/ RLA File :09/24/040/00155/AM13/ Lic.No/Date:0910053315 20.07.2012 Defer Date:24.01.2013 105
Case No.:31/21/82‐ALC4/2012
Party Name:MSN LABORATORIES LIMITED 29.12.2012 HQ File :01/82/050/00661/AM13/ RLA File :09/24/040/00171/AM13/ Lic.No/Date:0910053316 20.07.2012 Defer Date:24.01.2013
Case No.:35/18/82‐ALC4/2012
Party Name:INTAS PHARMACEUTICALS LTD., 29.12.2012
106 HQ File :01/82/050/00530/AM13/ RLA File :08/24/040/00128/AM13/ Lic.No/Date:0810113566 20.07.2012 Defer Date:24.01.2013 107
Case No.:61/21/82‐ALC4/2012
Party Name:SATYADEVA PHARMACEUTICALS /P/ LTD., 29.12.2012 HQ File :01/82/050/00691/AM13/ RLA File :09/24/040/00184/AM13/ Lic.No/Date:0910053311 20.07.2012 Defer Date:24.01.2013 108
Case No.:97/18/82‐ALC4/2012
29.12.2012 Status:Case Approved HQ File :01/82/050/00592/AM13/ RLA File :22/24/040/00022/AM13/ Lic.No/Date:2210013115 20.07.2012 Defer Date: 27.12.2012 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their F.No. No.35011/715/2012PI (Norms) dated 27.12.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg 2‐(1‐CYCLOHEXENYL) ETHYLAMINE 1 kg 1. CYANOACETIC ACID ‐ 70% 1.63 2. RANEY COBALT CATALYST 0.010 109
Case No.:99/18/82‐ALC4/2012
29.12.2012 Status:Case Approved HQ File :01/82/050/00594/AM13/ RLA File :22/24/040/00023/AM13/ Lic No/Date:2210013116 Defer Date:
HQ File :01/82/050/00594/AM13/ RLA File :22/24/040/00023/AM13/ Lic.No/Date:2210013116 20.07.2012 Defer Date: 27.12.2012 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their F.No. No.35011/715/2012PI (Norms) dated 27.12.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg 2‐(1‐CYCLOHEXENYL) ETHYLAMINE 1 kg 1. CYANOACETIC ACID ‐ 70% 1.63 2. RANEY COBALT CATALYST 0.010 110
Case No.:48/18/82‐ALC4/2012
Party Name:RONAK CHEMICALS 29.12.2012 HQ File :01/82/050/00543/AM13/ RLA File :34/24/040/00109/AM13/ Lic.No/Date:3410034708 23.07.2012 Defer Date:24.01.2013 Decision :It was decided to defer the case for 24.1.2013 for comments of Department of Chemicals and Petrochemicals. 111
Case No.:1/15/82‐ALC4/2012
Party Name:EMCURE PHARMACEUTICALS LTD. 29.12.2012 HQ File :01/82/050/00436/AM13/ RLA File :31/83/040/00067/AM13/ Lic.No/Date:3110055076 24.07.2012 Defer Date:24.01.2013 112
Case No.:58/21/82‐ALC4/2012
Party Name:SRINI PHARMACEUTICALS LTD., 29.12.2012 HQ File :01/82/050/00688/AM13/ RLA File :09/24/040/00166/AM13/ Lic.No/Date:0910053338 24.07.2012 Defer Date:24.01.2013
113
Case No.:101/18/82‐ALC4/2012
Party Name:NECTAR LIFESCIENCES LIMITED, 29.12.2012 HQ File :01/82/050/00596/AM13/ RLA File :22/24/040/00025/AM13/ Lic.No/Date:2210013124 25.07.2012 Defer Date:24.01.2013 114
Case No.:11/21/82‐ALC4/2012
Party Name:ANUH PHARMA LTD. 29.12.2012 HQ File :01/82/050/00641/AM13/ RLA File :03/94/040/00293/AM13/ Lic.No/Date:0310703076 25.07.2012 Defer Date:24.01.2013 115
Case No.:14/21/82‐ALC4/2012
Party Name:SALVI CHEMICAL INDUSTRIES LIMITED 29.12.2012 HQ File :01/82/050/00644/AM13/ RLA File :03/95/040/00259/AM13/ Lic.No/Date:0310703111 25.07.2012 Defer Date:24.01.2013 116
Case No.:55/21/82‐ALC4/2012
Party Name:AUROBINDO PHARMA LIMITED 29.12.2012 HQ File :01/82/050/00685/AM13/ RLA File :09/24/040/00203/AM13/ Lic.No/Date:0910053388 31.07.2012 Defer Date:24.01.2013
117
Case No.:100/18/82‐ALC4/2012
29.12.2012 Status:Case Approved HQ File :01/82/050/00595/AM13/ RLA File :22/24/040/00026/AM13/ Lic.No/Date:2210013133 01.08.2012 Defer Date: 27.12.2012 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their F.No. No.35011/716/2012PI (Norms) dated 27.12.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg CYANOACETIC ACID 1 kg 1. CYANOACETIC ACID ‐ 70% (Contains 30% water) 1.587 118
Case No.:17/20/82‐ALC4/2012
Party Name:RANBAXY LABORATORIES LTD 29.12.2012 HQ File :01/82/050/00628/AM13/ RLA File :05/24/040/00148/AM13/ Lic.No/Date:0510331126 01.08.2012 Defer Date:24.01.2013 119
Case No.:17/21/82‐ALC4/2012
Party Name:LUPIN LIMITED 29.12.2012 HQ File :01/82/050/00647/AM13/ RLA File :03/95/040/00304/AM13/ Lic.No/Date:0310704078 03.08.2012 Defer Date:24.01.2013 120
Case No.:18/21/82‐ALC4/2012
Party Name:LUPIN LIMITED 29 12 2012
29.12.2012 HQ File :01/82/050/00648/AM13/ RLA File :03/95/040/00303/AM13/ Lic.No/Date:0310704080 03.08.2012 Defer Date:24.01.2013 121
Case No.:35/21/82‐ALC4/2012
Party Name:PADMINI AROMATICS PVT. LTD 29.12.2012 HQ File :01/82/050/00665/AM13/ RLA File :07/24/040/00177/AM13/ Lic.No/Date:0710090045 03.08.2012 Defer Date:24.01.2013 122
Case No.:48/21/82‐ALC4/2012
Party Name:ALEMBIC PHARMACEUTICALS LTD 29.12.2012 HQ File :01/82/050/00678/AM13/ RLA File :34/24/040/00118/AM13/ Lic.No/Date:3410034784 03.08.2012 Defer Date:24.01.2013 123
Case No.:63/21/82‐ALC4/2012
Party Name:ASTRIX LABORATORIES LTD., 29.12.2012 HQ File :01/82/050/00693/AM13/ RLA File :09/24/040/00227/AM13/ Lic.No/Date:0910053422 03.08.2012 Defer Date:24.01.2013 124
Case No.:19/21/82‐ALC4/2012
Party Name:LUPIN LIMITED 29.12.2012 HQ File :01/82/050/00649/AM13/ RLA File :03/95/040/00305/AM13/ Lic.No/Date:0310704227 06.08.2012 Defer Date:24.01.2013
125
Case No.:3/18/82‐ALC4/2012
Party Name:UNITED BIOTECH PVT.LTD. 29.12.2012 HQ File :01/82/050/00498/AM13/ RLA File :05/24/040/00185/AM13/ Lic.No/Date:0510331907 14.08.2012 Defer Date:24.01.2013 126
Case No.:65/21/82‐ALC4/2012
Party Name:INCHEM LABORATORIES PRIVATE LIMITED 29.12.2012 HQ File :01/82/050/00695/AM13/ RLA File :09/24/040/00239/AM13/ Lic.No/Date:0910053490 14.08.2012 Defer Date:24.01.2013 Decision :It was decided to remind the firm to furnish the technical details as per Appendix 33 within 15 days failing which the case would be closed. The case was deferred for 24.1.2013 127
Case No.:70/21/82‐ALC4/2012
29.12.2012 Status:Case Approved HQ File :01/82/050/00700/AM13/ RLA File :22/24/040/00028/AM13/ Lic.No/Date:2210013172 14.08.2012 Defer Date: 27.12.2012 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their F.No. No.35011/716/2012PI (Norms) dated 27.12.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg CYANOACETIC ACID 1 kg 1. CYANOACETIC ACID ‐ 70% (Contains 30% water) 1.587
128
Case No.:32/21/82‐ALC4/2012
Party Name:BIO‐TECH OPHTHALMICS PVT. LTD., 29.12.2012 Status:Case Approved HQ File :01/82/050/00662/AM13/ RLA File :08/24/040/00137/AM13/ Lic.No/Date:0810114338 17.08.2012 Defer Date: 27.12.2012 Decision : Committee considered case as per agenda and it was decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Nos. Sl.No. Import items For export of 1 No. Tablets SODIUM HYALURONATE OPHTHALMICS SOLUTION (PREFILLED SYRINGE) 50000 1. BARRELS (HYPAK SCF 3 ML RF PRTC FM 27) COMPONNENT FOR PREFILLED SYRINGE) (HEIGHT 91.7 MM, DIAMETER (EXTERNAL) 10.85 MM, DIAMETER (INTERNAL) 8.65 & WEIGHT 7.8233 GM ( 10% + / ‐ ) ) Relevant as per packing policy 2. PLUNGER ROD (HYPAK PR 3 ML PP EPL) ( COMPONENT FOR PREFILLED SYRINGE ) (LENGTH 74.75 MM , WIDTH 7.87 MM (+ / ‐ 10%) ) Relevant as per packing policy 3. PLUNGER STOPPER ( HYPAK BSCF 1‐3 ML PH 701/50 BLACK LID) ( COMPONENT FOR PREFILLED SYRINGE) (HEIGHT 7.7 MM , OUTER DIAMETER 9.15 MM, INNER DIAMETER 6.25 MM ( + / ‐ 10%) ) Relevant as per packing policy 4. BACK STOP (1‐3 ML PP CLEAR) (COMPONENT FOR PREFILLED SYRINGE) LENGTH 24.2 MM, WIDTH Relevant as per packing policy
16.50 MM, HEIGHT 5.1 MM ( + /‐ 10%) ) 5. BLISTER ( PP BLISTER 2.25 ML / 3.0 ML) (PACKING MATERIAL FOR PREFILLED SYRINGE) Relevant as per packing policy 6. TYVEK ROLL (PACKING MATERIAL FOR PREFILLED SYRINGE) (WIDTH 65 MM ) ( THIS LICENCE IS ISSUED AS PER
PARA 4.7 OF H.B.AM2009‐14
& SUBJECT TO FIXATION OF NORMS BY ALC N.DELHI.) Relevant as per packing policy 129
Case No.:40/21/82‐ALC4/2012
Party Name:VITAL LABORATORIES PVT. LTD. 29.12.2012 HQ File :01/82/050/00670/AM13/ RLA File :03/95/040/00254/AM13/ Lic.No/Date:0310705409 17.08.2012 Defer Date:24.01.2013 130
Case No.:41/21/82‐ALC4/2012
Party Name:MEDLEY PHARMACEUTICALS LIMITED 29.12.2012 HQ File :01/82/050/00671/AM13/ RLA File :03/95/040/00273/AM13/ Lic.No/Date:0310705411 17.08.2012 Defer Date:24.01.2013 131
Case No.:62/21/82‐ALC4/2012
Party Name:VASUDHA PHARMA CHEM LTD 29.12.2012 HQ File :01/82/050/00692/AM13/ RLA File :09/24/040/00204/AM13/ Lic.No/Date:0910053534 Defer
17.08.2012 Date:24.01.2013 132
Case No.:64/21/82‐ALC4/2012
Party Name:ECOLOGIC CHEMICALS LIMITED 29.12.2012 HQ File :01/82/050/00694/AM13/ RLA File :09/24/040/00199/AM13/ Lic.No/Date:0910053533 17.08.2012 Defer Date:24.01.2013 133
Case No.:36/21/82‐ALC4/2012
Party Name:CADILA HEALTHCARE LTD., 29.12.2012 HQ File :01/82/050/00666/AM13/ RLA File :08/24/040/00147/AM13/ Lic.No/Date:0810114381 21.08.2012 Defer Date:24.01.2013 134
Case No.:69/21/82‐ALC4/2012
Party Name:ASCENT FINECHEM PVT. LTD., 29.12.2012 HQ File :01/82/050/00699/AM13/ RLA File :08/24/040/00160/AM13/ Lic.No/Date:0810114398 21.08.2012 Defer Date:24.01.2013 135
Case No.:24/21/82‐ALC4/2012
Party Name:R L FINE CHEM 29.12.2012 HQ File :01/82/050/00654/AM13/ RLA File :07/24/040/00218/AM13/ Lic.No/Date:0710090322 22.08.2012 Defer Date:24.01.2013
136
Case No.:33/21/82‐ALC4/2012
Party Name:SYMBIOTEC PHARMALAB LTD., 29.12.2012 Status:Case Approved HQ File :01/82/050/00663/AM13/ RLA File :56/24/040/00014/AM13/ Lic.No/Date:5610000958 22.08.2012 Defer Date: 27.12.2012 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their F.No. No.35011/568/2012PI (Norms) dated 26.12.2012, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Methylprednisolone Sodium Succinate USP (Methylprednisolone Sodium Succinate Buffered 3% Sterile) 1 Kg. 1. Methylprednisolone Hemisuccinate USP Organic Chemicals 0.966 137
Case No.:52/21/82‐ALC4/2012
Party Name:BAL PHARMA LTD 29.12.2012 HQ File :01/82/050/00682/AM13/ RLA File :07/24/040/00221/AM13/ Lic.No/Date:0710090348 23.08.2012 Defer Date:24.01.2013 138
Case No.:6/21/82‐ALC4/2012
Party Name:UNITED BIOTECH PVT.LTD. 29.12.2012 HQ File :01/82/050/00636/AM13/ RLA File :05/24/040/00202/AM13/ Lic.No/Date:0510332772 28.08.2012 Defer Date:24.01.2013
139
Case No.:25/21/82‐ALC4/2012
Party Name:DHANUKA LABORATORIES LTD. 29.12.2012 HQ File :01/82/050/00655/AM13/ RLA File :05/23/040/00183/AM13/ Lic.No/Date:0510333412 03.09.2012 Defer Date:24.01.2013 140
Case No.:69/24/82‐ALC4/2012
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 29.12.2012 HQ File :01/82/050/00873/AM13/ RLA File :03/95/040/00323/AM13/ Lic.No/Date:0310707470 03.09.2012 Defer Date:24.01.2013 141
Case No.:39/26/82‐ALC4/2012
Party Name:AUCTUS PHARMA LIMITED 29.12.2012 HQ File :01/82/050/00947/AM13/ RLA File :09/24/040/00276/AM13/ Lic.No/Date:0910053682 06.09.2012 Defer Date:24.01.2013 142
Case No.:83/22/82‐ALC4/2012
Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 29.12.2012 HQ File :01/82/050/00786/AM13/ RLA File :03/94/040/00498/AM11/ Lic.No/Date:0310707992 06.09.2012 Defer Date:24.01.2013
143
Case No.:99/24/82‐ALC4/2012
Party Name:AMI LIFESCIENCES P LTD 29.12.2012 HQ File :01/82/050/00903/AM13/ RLA File :34/24/040/00153/AM13/ Lic.No/Date:3410035105 10.09.2012 Defer Date:24.01.2013 144
Case No.:2/21/82‐ALC4/2012
Party Name:ZEE LABORATORIES 29.12.2012 HQ File :01/82/050/00632/AM13/ RLA File :05/24/040/00220/AM13/ Lic.No/Date:0510334505 12.09.2012 Defer Date:24.01.2013 145
Case No.:3/21/82‐ALC4/2012
Party Name:CADILA HEALTHCARE LTD., 29.12.2012 HQ File :01/82/050/00633/AM13/ RLA File :08/24/040/00144/AM13/ Lic.No/Date:0810115056 12.09.2012 Defer Date:24.01.2013 146
Case No.:62/24/82‐ALC4/2012
Party Name:AMBUJA INTERMEDIATES LIMITED 29.12.2012 HQ File :01/82/050/00866/AM13/ RLA File :03/94/040/00383/AM13/ Lic.No/Date:0310709139 14.09.2012 Defer Date:24.01.2013 147
Case No.:66/24/82‐ALC4/2012
Party Name:IPCA LABORATORIES LIMITED 29.12.2012 HQ File :01/82/050/00870/AM13/ RLA File :03/94/040/00423/AM13/ Lic.No/Date:0310709103 14.09.2012 Defer Date:24.01.2013
148
Case No.:77/24/82‐ALC4/2012
Party Name:ASHISH LIFE SCIENCE PVT.LTD. 29.12.2012 HQ File :01/82/050/00881/AM13/ RLA File :03/94/040/00378/AM13/ Lic.No/Date:0310709108 14.09.2012 Defer Date:24.01.2013 149
Case No.:63/24/82‐ALC4/2012
Party Name:GOPALDAS VISRAM & CO.LTD. 29.12.2012 HQ File :01/82/050/00867/AM13/ RLA File :03/94/040/00409/AM13/ Lic.No/Date:0310709515 18.09.2012 Defer Date:24.01.2013 150
Case No.:74/24/82‐ALC4/2012
Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 29.12.2012 HQ File :01/82/050/00878/AM13/ RLA File :03/94/040/00460/AM13/ Lic.No/Date:0310709540 18.09.2012 Defer Date:24.01.2013 151
Case No.:75/24/82‐ALC4/2012
Party Name:IPCA LABORATORIES LIMITED 29.12.2012 Status:Case Approved HQ File :01/82/050/00879/AM13/ RLA File :03/94/040/00300/AM13/ Lic.No/Date:0310709528 18.09.2012 Defer Date: 27.12.2012 Decision : Commilee considered case as per agenda for ralficalon of norms and in light of earlier decision taken in 42/82 dated 17.01.2012 and in consultalon with the technical authoriles present in the meelng, decided to ralfy 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 per unit of export product CLOBETASOL ‐ 17 PROPIONATE 1 Kg. 1. Betamethasone 1.04 kg/kg RA concerned may take further necessary aclon as per above decision of NC. 152
Case No.:70/24/82‐ALC4/2012
Party Name:BAYER CROPSCIENCE LIMITED 29.12.2012 Status:Transferred to Different Seclon HQ File :01/82/050/00874/AM13/ RLA File :03/94/040/00321/AM13/ Lic.No/Date:0310709768 20.09.2012 Defer Date:27.12.2012 Decision :The case was transferred to DES IV Seclon in meelng no. 25/82 dated 29.11.2012. Therefore the case was withdrawn. 153
Case No.:72/21/82‐ALC4/2012
Party Name:BELCO PHARMA 29.12.2012 HQ File :01/82/050/00702/AM13/ RLA File :05/23/040/00176/AM13/ Lic.No/Date:0510335291 20.09.2012 Defer Date:24.01.2013 154
Case No.:72/24/82‐ALC4/2012
Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. 29.12.2012 HQ File :01/82/050/00876/AM13/ RLA File :03/94/040/00393/AM13/ Lic.No/Date:0310709757 20.09.2012 Defer Date:24.01.2013
Case No.:88/24/82‐ALC4/2012
Party Name:CHEMSPEC CHEMICALS PVT LTD Meet No/Date:27/82‐ALC4/2012 Status:Case Deferred
155
Case No.:88/ 4/8
A C4/ 0 Party Name:CH MSP C CH MICA S PVT T Meet No/ ate: 7/8 A C4/ 0 29.12.2012 Status:Case eferred HQ File :01/82/050/00892/AM13/ RLA File :03/94/040/00230/AM13/ Lic.No/Date:0310709870 21.09.2012 Defer Date:24.01.2013 156
Case No.:97/24/82‐ALC4/2012
Party Name:KUTCH CHEMICAL INDUSTRIES LTD., 29.12.2012 HQ File :01/82/050/00901/AM13/ RLA File :34/24/040/00164/AM13/ Lic.No/Date:3410035217 21.09.2012 Defer Date:24.01.2013 157
Case No.:87/24/82‐ALC4/2012
Party Name:METROPOLITAN EXIMCHEM LTD. 29.12.2012 HQ File :01/82/050/00891/AM13/ RLA File :03/95/040/00466/AM13/ Lic.No/Date:0310710207 24.09.2012 Defer Date:24.01.2013 158
Case No.:98/24/82‐ALC4/2012
Party Name:ENVEE DRUGS PVT LTD 29.12.2012 Status:Case Approved HQ File :01/82/050/00902/AM13/ RLA File :34/24/040/00163/AM13/ Lic.No/Date:3410035223 25.09.2012 Defer Date: 27.12.2012 Decision : Commilee considered case as per agenda for ralficalon of norms and in light of earlier decision taken in 42/82 dated 17.01.2012 and in consultalon with the technical authoriles present in the meelng, decided to ralfy 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 per unit of export product CLOBETASOL PROPIONATE BP/USP 1 Kg 1 Betamethasone BP/USP 1 04 kg/kg
CLOBETASOL PROPIONATE BP/USP 1 Kg. 1. Betamethasone BP/USP 1.04 kg/kg RA concerned may take further necessary aclon as per above decision of NC. 159
Case No.:85/24/82‐ALC4/2012
Party Name:MAKSON INDUSTRIES PVT. LTD. 29.12.2012 HQ File :01/82/050/00889/AM13/ RLA File :03/95/040/00394/AM13/ Lic.No/Date:0310710561 26.09.2012 Defer Date:24.01.2013 Decision :It was decided to defer the case for 24.1.2013 for comments of Department of MSME. 160
Case No.:86/24/82‐ALC4/2012
Party Name:RUPA ORGANICS PVT. LTD. 29.12.2012 HQ File :01/82/050/00890/AM13/ RLA File :03/95/040/00478/AM13/ Lic.No/Date:0310710764 27.09.2012 Defer Date:24.01.2013 161
Case No.:76/24/82‐ALC4/2012
Party Name:ENCUBE ETHICALS PVT LTD 29.12.2012 HQ File :01/82/050/00880/AM13/ RLA File :03/94/040/00500/AM13/ Lic.No/Date:0310711014 28.09.2012 Defer Date:24.01.2013 162
Case No.:84/24/82‐ALC4/2012
Party Name:NANDOLIA ORGANIC CHEMICALS PVT.LTD 29.12.2012 HQ File :01/82/050/00888/AM13/ RLA File :03/95/040/00483/AM13/ Lic.No/Date:0310710875 28.09.2012 Defer Date:24.01.2013
163
Case No.:96/24/82‐ALC4/2012
Party Name:TIDE INDUSTRIES 29.12.2012 HQ File :01/82/050/00900/AM13/ RLA File :34/24/040/00158/AM13/ Lic.No/Date:3410035264 01.10.2012 Defer Date:24.01.2013 164
Case No.:68/24/82‐ALC4/2012
Party Name:STERLING AUXILIARIES PVT LTD 29.12.2012 HQ File :01/82/050/00872/AM13/ RLA File :03/95/040/00427/AM13/ Lic.No/Date:0310711299 03.10.2012 Defer Date:24.01.2013 165
Case No.:52/24/82‐ALC4/2012
Party Name:INDO PHYTO CHEMICALS PVT LTD 29.12.2012 HQ File :01/82/050/00856/AM13/ RLA File :05/23/040/00253/AM13/ Lic.No/Date:0510336431 04.10.2012 Defer Date:24.01.2013 166
Case No.:91/24/82‐ALC4/2012
Party Name:SMB MEDICAL DEVICES PVT. LTD. 29.12.2012 HQ File :01/82/050/00895/AM13/ RLA File :03/95/040/00446/AM13/ Lic.No/Date:0310712446 11.10.2012 Defer Date:24.01.2013 Decision : It was decided to defer the case for 24.1.2013 for comments of Department of IPP.
Case No.:92/24/82‐ALC4/2012
Party Name:UNITED MUD‐CHEM PVT. LTD. 29.12.2012
167 HQ File :01/82/050/00896/AM13/ RLA File :03/95/040/00527/AM13/ Lic.No/Date:0310712861 16.10.2012 Defer Date:24.01.2013 168
Case No.:3/23/82‐ALC4/2012
Party Name:TITAN LABORATORIES PVT. LTD. 29.12.2012 HQ File :01/82/050/00803/AM13/ RLA File :03/95/040/00544/AM13/ Lic.No/Date:0310713360 22.10.2012 Defer Date:24.01.2013 169
Case No.:95/24/82‐ALC4/2012
Party Name:SOLARIS CHEMTECH INDUSTRIES LTD. 29.12.2012 HQ File :01/82/050/00899/AM13/ RLA File :34/24/040/00188/AM13/ Lic.No/Date:3410035412 01.11.2012 Defer Date:24.01.2013 170
Case No.:1/25/82‐ALC4/2012
Party Name:SWISS PARENTERALS PVT.LTD. 29.12.2012 HQ File :01/82/050/00905/AM13/ RLA File :08/24/040/00271/AM13/ Lic.No/Date:0810116219 09.11.2012 Defer Date:24.01.2013 171
Case No.:1/27/82‐ALC4/2012
Party Name:PORUS LABORATORIES PVT LTD. 29.12.2012 HQ File :01/82/050/00956/AM13/ RLA File :09/24/040/00426/AM13/ Lic.No/Date:0910054427 03.12.2012 Defer Date:24.01.2013
172
Case No.:2/27/82‐ALC4/2012
Party Name:GOPINATH CHEM‐TECH LTD., 29.12.2012 HQ File :01/82/050/00957/AM13/ RLA File :08/24/040/00295/AM13/ Lic.No/Date:0810116627 04.12.2012 Defer Date:24.01.2013 173
Case No.:3/27/82‐ALC4/2012
Party Name:SHIVA PHARMACHEM LTD, 29.12.2012 HQ File :01/82/050/00958/AM13/ RLA File :34/24/040/00211/AM13/ Lic.No/Date:3410035623 06.12.2012 Defer Date:24.01.2013 174
Case No.:4/27/82‐ALC4/2012
Party Name: LABORATORIES PVT LTD. 29.12.2012 HQ File :01/82/050/00959/AM13/ RLA File :09/24/040/00408/AM13/ Lic.No/Date:0910054464 07.12.2012 Defer Date:24.01.2013 Decision : It was decided to defer the case for 24.1.2013 for comments of Department of Chemicals and Petrochemicals. 175
Case No.:5/27/82‐ALC4/2012
Party Name:TORRENT PHARMACEUTICALS LTD. 29.12.2012 Status:Case Approved HQ File :01/82/050/00960/AM13/ RLA File :08/24/040/00310/AM13/ Lic.No/Date:0810116742 07.12.2012 Defer Date: 27.12.2012 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under Para 4.7 of HBP v1 as per SION A412 with 2 % wastage. Export product Exp Qty Sl No Import items Qty allowed
Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Acemetacin Capsules Acemetacin 30 Heumann (Pack Size 20, 50 & 100 Capsules) Each capsule contains Acemetacin 30mg, excipient q.s. Net content of aclve ingredient Acemetacin should not be less than 70 kgs in export product 1 Number 1. Acemetacin Condn.:‐This licence issued under
para 4.7 of H.B. 2009‐14 for
fixalon of norms by ALC.,New Delhi. (2) This license is issued in terms of policy circular No.9 dtd.30.06.2003 and public nolce No.31 dtd.14.02.2011 30.6 mg Acemetacin Capsules Acemetacin 60 Heumann (Pack Size 20, 50 & 100 Capsules) Each capsule contains Acemetacin 60mg, excipient q.s. Net content of aclve ingredient Acemetacin should not be less than 70 kgs in export product 2. Acemetacin Condn.:‐This licence issued under
para 4.7 of H.B. 2009‐14 for
fixalon of norms by ALC.,New Delhi. (2) This license is issued in terms of policy circular No.9 dtd.30.06.2003 and public nolce No.31 dtd.14.02.2011 61.2 mg RA concerned may take further necessary action as per above decision of NC. 176
Case No.:6/27/82‐ALC4/2012
Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. Meet No/Date:27/82‐ALC4/2012 29.12.2012 HQ File :01/82/050/00961/AM13/ RLA File :31/83/040/00149/AM13/ Lic.No/Date:3110056435 07.12.2012 Defer Date:24.01.2013
Case No.:7/27/82‐ALC4/2012
Party Name:TORRENT PHARMACEUTICALS LTD. 29.12.2012
177 HQ File :01/82/050/00962/AM13/ RLA File :08/24/040/00293/AM13/ Lic.No/Date:0810116756 10.12.2012 Defer Date:24.01.2013 178
Case No.:8/27/82‐ALC4/2012
Party Name:RA CHEM PHARMA LIMITED 29.12.2012 Status:Case Approved HQ File :01/82/050/00963/AM13/ RLA File :09/24/040/00433/AM13/ Lic.No/Date:0910054465 10.12.2012 Defer Date: 27.12..2012 Decision : Committee considered case as per agenda and in light of SION A322 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Export Qty. Sl.No. Import items Qty. allowed Flurbiprofen Pellets 60% 1 KG. 1. Flurbiprofen 0.606 kg RA concerned may take further necessary action as per above decision of NC. 179
Case No.:10/27/82‐ALC4/2012
Party Name:AUROBINDO PHARMA LIMITED 29.12.2012 HQ File :01/82/050/00965/AM13/ RLA File :09/24/040/00416/AM13/ Lic.No/Date:0910054496 12.12.2012 Defer Date:24.01.2013 180
Case No.:9/27/82‐ALC4/2012
Party Name:AUROBINDO PHARMA LIMITED 29.12.2012 HQ File :01/82/050/00964/AM13/ RLA File :09/24/040/00418/AM13/ Lic.No/Date:0910054495 12.12.2012 Defer Date:24.01.2013
Case No.:11/27/82‐ALC4/2012
Party Name:IND‐SWIFT LABORATORIES LTD., 29.12.2012
181 HQ File :01/82/050/00966/AM13/ RLA File :22/24/040/00051/AM13/ Lic.No/Date:2210013450 17.12.2012 Defer Date:24.01.2013 182
Case No.:12/27/82‐ALC4/2012
Party Name:POLYGON CHEMICALS 29.12.2012 HQ File :01/82/050/00967/AM13/ RLA File :08/24/040/00327/AM13/ Lic.No/Date:0810116927 18.12.2012 Defer Date:24.01.2013 Date:07.01.2013 Place:New Delhi Lalita Maini Foreign Trade Development Officer
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