DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi 0
Para 4.7 Decision
MEETING NUMBER : 14/82ALC4/2012 MEETING DATE : 31.07.2012 The Meeting No. 14/82 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 held on 31.07.2012 under the Chairmanship of Addl DGFT, Shri Mukesh Bhatnagar, in Room No.4, Udyog Bhawan, New Delh.. Following members were present: 1. Shri Jasbir Singh, Consultant, Department of Chemicals and Petrochemicals 2. Shri D.N. Mathur, Consultant, Department of Pharmaceutical 3. Shri R.C. Meena, Dy. Director General of Foreign Trade
Case No.A 3
M/s. Kopran Limited Norms Committee Meeting No.14/AM13 F.No.01/82/162/00212/AM12/DESIII Meeting Date:31.07.2012 Decision: It was decided to remind the firm to furnish copies of Bills of Entry and Shipping Bills. Accordingly, the case was deferred for 30.08.2012
Case No.B 219
M/s. Actavis Pharma Manufacturing Pvt. Limited, Chennai F.No.01/82/050/00178/AM 12/DES III F.No 01/82/050/00172/Am 12/DES III F.No 01/82/050/00176/AM 12/DES III Advance Authorisation No. 0410122523 dated 15.3.2011 0410122929 dated 25.3.2012 0410123157 dated 01.04.2011 RLA File No. 04/24/040/00331/AM 11 04/24/040/00355/AM 11 04/24/040/00359/AM 11 Decision: It was decided to send the application to Department of Pharmaceuticals for their comments. Accordingly, the case was deferred for 30.08.2012
Case No. B 220
M/s. Divis Laboratories Limited F.No.01/82/162/00113/AM13/DESIII Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/234/2012PI (Norms) dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is lower:
Export product Export Qty. Sl.No. Import items Qty. allowed (kg/kg) Dextromethorphan HBr 1 kg 1. NFormylOctabase [Sigma] 1.35 2. Phosphorus Pentoxide 1.30 3. Toluene 1.10 4. C S Flakes 2.90 5. Methanol 0.725 6. Vacuum Salt 0.13 7. Formaldehyde (40%) 0.66 8. Formic Acid (85%) 0.34 9. CS Lye 0.65 10 Activated Carbon 0.06 11 Acetone 0.208 12 HBr (47%) 0.66 RA may take appropriate action as per the decision of Norms Committee
Case No.B 221
M/s. Divis Laboratories Limited F.No.01/82/162/00112/AM13/DESIII Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No.35011/235/2012PI (Norms) dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed (kg/kg) Naproxen Sodium 1 kg 1. BNaphtol 1.29
Nitromethane 0.40 3. Acetyl Chloride 0.79 4. Aluminium Chloride 1.56 5. Mono Chloro Acetic Acid 1.02 6. 2Butanol 1.27 7. KOH Flakes 1.32 8. Acetic Acid 0.83 9. Hydroxylamine Sulfate (or) Hydroxylamine HCL 0.63 (or) 0.54 10. Activated Carbon 0.100 11. NOctylDGlucamine 0.100 12. Methanol 2.63 13. Ethylene Dichloride 0.89 14. Acetone 0.60 15. Toluene 1.80 16. Sulfuric Acid As per Central Excise Certificate 17. Sodium Carbonate 18. Sodium Hydrosulfite 19. pToluene Sulfonic Acid 20. HCL
21 Hyflo Super Cel 22 Ammonia Gas 23 Disodium EDTA 24 Vacuum Salt 25. C S Lye 4.00 RA may take appropriate action as per the decision of Norms Committee.
Case No. B 222
M/s. Divis Laboratories Limited F.No.01/82/162/00111/AM13/DESIII Decision: It was decided to send the application to the Department of Pharmaceuticals for their comments. Accordingly, the case was deferred for 30.08.2012
Case No. B 223
M/s. Divis Laboratories Limited F.No.01/82/162/00114/AM13/DESIII Decision: It was decided to defer the case for 30.8.2012 for comments of Department of Pharmaceuticals.
Case No. B 224
M/s. Vivimed Labs Limited F.No.01/82/162/0351/AM09/DESIII RLA File No. 09/24/040/00514/AM 08 Adv. Lic. No. 0910033449 dated 26.3.2008 Decision: It was decided to call from the production and consumption data duly certified by Central Excise Authorities for the last three years. Accordingly, the case was deferred for 30.8.2012.
Case No. B 225
M/s. Kedia Organic Chemicals Pvt. Ltd. F.No.01/82/50/01349/AM 11/DES III RLA File No. 03/94/40/00792/AM 11 Adv. Lic. No. 0310607421 dated 22.12.10 Decision: It was decided to amend the unit of export quantity from 1 kg to 1 litre. However, the request of the firm for enhancement of norms fixed by NC in its earlier meeting held on 45/82 dated 8.2.11 was rejected as there was no justification for enhancement. C N B 226 M/ J bil t Lif i Li it d
Case No. B 226
M/s. Jubilant Lifesciences Limited F.No.01/82/50/00921/AM 11/DES III RLA File No. 05/23/040/00168/AM 11 Adv. Lic. No. 0510274506 dated 8.10.10 Decision: It was decided to defer the case for 30.8.2012 for comments of Department of Chemicals and Petrochemicals.
Case No. B 227
M/s. Jubilant Lifesciences Limited F.No.01/82/50/00114/AM 12/DES III F.No. 01/82/50/00293/AM 12/DES III RLA File No. 05/24/040/00026/AM 12 RLA File No. 05/24/040/00046/AM 12 Adv. Lic. No. 0510288429 dated 20.4.2011 Adv. Lic. No. 0510291487 dated 24.05.2011 Decision: It was decided to defer the case for 30.8.2012 for comments of Department of Chemicals and Petrochemicals.
Case No. B 228
M/s. Jubilant Lifesciences Limited F.No.01/82/50/01481/AM 07/DES III F.No. 01/82/50/01710/AM07/DES III RLA File No. 05/24/040/00782/AM 07 RLA File No. 05/24/040/00972/AM 07 Adv. Lic. No. 0510196612 dated 21.12.2006 Adv. Lic. No. 0510200116 dated 27.02.2007 Decision: It was decided to maintain the decision taken by the Norms Committee in its earlier meeting No. 25/12 dated 20.9.2011. The Committee noted that there exist SION for Azacyclonol and further there is no justification for enhancement as the norms were fixed on the basis of comparative data.
Case No. C 32
M/s. Shasun Pharmaceuticals Limited F.No.01/82/162/01146/Am 11/DES III Decision: It was decided to close the case as the Committee noted that SION A 3249 exist for “Methohexital USP”.
Case No. C 33
M/s. Shasun Pharmaceuticals Limited F.No.01/82/162/00267/Am 11/DES III Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/231/2012PI (Norms) dated 24.7.2012, it was decided to include “Sodium Dichromate” in SION (A266) under Para 4.9 of HBP v1 as per details given below : Export product Export Qty. Sl.No. Import items Qty. allowed (kg/kg) Ib f 1 k 1 I b t l B 0 952
Ibuprofen 1 kg 1. Isobutyl Benzene 0.952 2. Acetyl Chloride 0.714 3. Isopropyl Alcohol 0.952 4 Sodium Metal 0.285 5. Monochloro Acetic Acid 1.25 6. Isopropyl Alcohol 1.00 7. Sodium Dichromate 0.63 Necessary Public Notice may be issued after approval of DG for publication of SION.
Case No. C 34
M/s. Shasun Pharmaceuticals Limited F.No.01/82/162/00261/Am 11/DES III Decision: It was decided to send the application to Department of Pharmaceuticals for their comments. Accordingly, the case was deferred for 30.8.2012. 1
Case No.:71/15/82ALC4/2010
Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:14/82ALC4/2012 31.07.2012 Status:Case Rejected HQ File :01/82/050/00508/AM11/ RLA File :22/24/040/00010/AM11/ Lic.No/Date:2210010065 14.06.2010 Defer Date: Decision : It was decided to close the case as despite reminder the firm has not submitted the requisite information. 2
Case No.:68/39/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 31.07.2012 Status:Case Rejected HQ File :01/82/050/01149/AM11/ RLA File :09/24/040/00054/AM11/ Lic.No/Date:0910042623 06.07.2010 Defer Date: Decision : It was decided to close the case as neither the firm’s representative come for Personal Hearing nor furnish the requisite documents.
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Case No.:72/39/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 31.07.2012 Status:Case Rejected HQ File :01/82/050/01153/AM11/ RLA File :09/24/040/00146/AM11/ Lic.No/Date:0910042671 12.07.2010 Defer Date: Decision : It was decided to close the case as the firm has not furnished information despite repeated reminders. 4
Case No.:19/28/82ALC4/2010
Party Name:ALEMBIC LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/00901/AM11/ RLA File :34/24/040/00121/AM11/ Lic.No/Date:3410028152 30.09.2010 Defer Date: 30.08.2012 Decision : It was decided to defer the case for 30.8.2012 for comments of Department of Pharmaceuticals. 5
Case No.:3/31/82ALC4/2010
Party Name:EMAMI LIMITED, 31.07.2012 Status:Case Deferred HQ File :01/82/050/00928/AM11/ RLA File :02/24/040/00119/AM11/ Lic.No/Date:0210149202 12.10.2010 Defer Date:30.08.2012 Decision : It was decided to defer the case for 30.8.2012 for comments of DC(MSME). 6
Case No.:124/40/82ALC4/2010
Party Name:SURYA PHARMACEUTICAL LTD 31.07.2012 Status:Case Approved HQ File :01/82/050/01323/AM11/ RLA File :22/24/040/00049/AM11/ Lic.No/Date:2210010535 18.10.2010 Defer Date: Decision : It was decided that RA may be advised to fix norms as per revised SION issued vide Public Notice 71 dated 12.8.2011. 7
Case No.:57/40/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 31.07.2012 Status:Case Deferred HQ File :01/82/050/01256/AM11/ RLA File :09/24/040/00237/AM11/ Lic.No/Date:0910043987 20.10.2010 Defer Date:30.08.2012 Decision : It was decided to send the application to Department of Pharmaceuticals for their comments. Accordingly, the case was deferred for 30.8.2012. 8
Case No.:63/40/82ALC4/2010
Party Name:EMAMI LIMITED, 31.07.2012 Status:Case Deferred HQ File :01/82/050/01262/AM11/ RLA File :02/24/040/00120/AM11/ Lic.No/Date:0210149565 25.10.2010 Defer Date:30.08.2012 Decision : It was decided to defer the case for 30.8.2012 for comments of DC(MSME).
Case No.:56/40/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 31 07 2012 Status:Case Deferred
9 31.07.2012 Deferred HQ File :01/82/050/01255/AM11/ RLA File :09/24/040/00236/AM11/ Lic.No/Date:0910044022 26.10.2010 Defer Date:30.08.2012 Decision : It was decided to send the application to Department of Pharmaceuticals for their comments. Accordingly, the case was deferred for 30.08.2012. 10
Case No.:8/32/82ALC4/2010
Party Name:SAURAV CHEMICALS LTD, 31.07.2012 Status:Case Deferred HQ File :01/82/050/00990/AM11/ RLA File :22/24/040/00050/AM11/ Lic.No/Date:2210010581 28.10.2010 Defer Date:30.08.2012 Decision : It was decided to call from Regional Authority, Calcutta a complete set of application. Accordingly, the case was deferred for 30.8.2012. 11
Case No.:2/34/82ALC4/2010
Party Name:ALEMBIC LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01008/AM11/ RLA File :34/24/040/00207/AM11/ Lic.No/Date:3410028544 09.11.2010 Defer Date:30.08.2012 Decision : It was decided to defer the case for 30.8.2012 for comments of Department of Pharmaceuticals. 12
Case No.:44/40/82ALC4/2010
Party Name:LUPIN LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01243/AM11/ RLA File :03/95/040/00638/AM11/ Lic.No/Date:0310600874 11.11.2010 Defer Date:30.08.2012 Decision : It was decided to send the application to Department of Pharmaceuticals for their comments. Accordingly, the case was deferred for 30.8.2012. 13
Case No.:25/40/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 31.07.2012 Status:Case Deferred HQ File :01/82/050/01224/AM11/ RLA File :09/24/040/00238/AM11/ Lic.No/Date:0910044429 25.11.2010 Defer Date:30.08.2012 Decision : It was decided to send the application to Department of Pharmaceuticals for their comments. Accordingly, the case was deferred for 30.8.2012. 14
Case No.:24/47/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01614/AM11/ RLA File :09/24/040/00404/AM11/ Lic.No/Date:0910044631 10.12.2010 Defer Date:30.08.2012 Decision : It was decided to send the application to Department of Pharmaceuticals for their comments. Accordingly, the case was deferred for 30.8.2012.
15
Case No.:43/3/82ALC4/2011
Party Name:MATRIX LABORATORIES LTD 31.07.2012 Status:Case Rejected HQ File :01/82/050/00043/AM12/ RLA File :09/24/040/00452/AM11/ Lic.No/Date:0910045290 28.01.2011 Defer Date: Decision : It was decided to close the case as the firm has not furnished information despite repeated reminders. 16
Case No.:44/3/82ALC4/2011
Party Name:MATRIX LABORATORIES LTD 31.07.2012 Status:Case Rejected HQ File :01/82/050/00044/AM12/ RLA File :09/24/040/00422/AM11/ Lic.No/Date:0910045287 28.01.2011 Defer Date: Decision : It was decided to close the case as the firm has not furnished information despite repeated reminders. 17
Case No.:32/48/82ALC4/2010
Party Name:DR. SABHARWALS WOUND CARE 31.07.2012 Status:Case Deferred HQ File :01/82/050/01675/AM11/ RLA File :06/24/040/00057/AM11/ Lic.No/Date:0610020786 01.02.2011 Defer Date:30.08.2012 Decision : In the light of written comments received from DIPP vide their note dated 30.7.2012, it was decided to call from the firm production and consumption data duly certified by Central Excise Authority. Accordingly, the case was deferred for 30.8.2012. 18
Case No.:5/4/82ALC4/2011
Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 31.07.2012 Status:Case Deferred HQ File :01/82/050/00056/AM12/ RLA File :03/95/040/00949/AM11/ Lic.No/Date:0310620143 08.03.2011 Defer Date:30.08.2012 Decision : It was decided to remind the Department of Biotechnology to furnish comments. Accordingly, the case was deferred for 30.8.2012. 19
Case No.:25/14/82ALC4/2012
Party Name:CIPLA LIMITED 31.07.2012 Status:Case Approved HQ File :01/82/050/00402/AM13/ RLA File :03/94/040/01121/AM11/ Lic.No/Date:0310622682 22.03.2011 Defer Date: Decision : In the light of earlier decision taken in meeting no. 30/82 dated 25.10.11, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Aerobud 100mcg Inhaler (200MD) with 50mcl Aerosol Valve (Budenoside inhaler 100mcg (200MD)) with 50 mcl Aerosol Valve) 1 No. 1. Budenoside 0.02 gm. 2. Aerosol Valves 50mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. 0.5 mm OD Acuators with dust As per packing
covers/caps fitting to 19ml Aluminium Can p p g policy 5. Zephex 134 A (1,1,1,2 Tetrafluoro ethane)(HFA 134 A Propellant) 14.4 gm. Aerobud 200mcg Inhaler (200MD) with 50mcl Aerosol Valve (Budenoside inhaler 200mcg (200MD)) with 50 mcl Aerosol Valve) 1 No. 1. Budenoside 0.04 gm. 2. Aerosol Valves 50mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 14.4 gm. Aerobud 100mcg Inhaler (200MD) with 58mcl Aerosol Valve (Budenoside inhaler 100mcg (200MD)) with 58 mcl Aerosol Valve) 1 No. 1. Budenoside 0.02 gm. 2. Aerosol Valves 58mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 18.2 gm. Aerobud 200mcg Inhaler (200MD) with 58mcl Aerosol Valve (Budenoside inhaler 200mcg (200MD)) with 58 mcl Aerosol Valve) 1 No. 1. Budenoside 0.04 gm. 2. Aerosol Valves 58mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 18.2 gm. Aerobud 200mcg Inhaler (200MD) with 63mcl Aerosol Valve (Budenoside inhaler 200mcg (200MD)) with 63 mcl Aerosol Valve (Contains Zephex 134 A & Ethanol) 1 No. 1. Budenoside 0.04 gm. 2. Aerosol Valves 63 mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 15.5 gm. 6. Ethanol 2.73 gm. Aerobud 100mcg Inhaler (300MD) with 40mcl Aerosol Valve (Budenoside inhaler 100mcg (300MD)) with 40 mcl Aerosol Valve) 1 No. 1. Budenoside 0.03 gm. 2. Aerosol Valves 40mcl As per packing policy 3. 19ml Aluminium Cans As per packing polic
mcl Aerosol Valve) policy 4. Aluminium Can As per packing policy 5. 17.0 gm. Aerobud 200mcg Inhaler (300MD) with 40mcl Aerosol Valve (Budenoside inhaler 200mcg (300MD)) with 40 mcl Aerosol Valve) 1 No. 1. Budenoside 0.06 gm. 2. Aerosol Valves 40mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 17.0 gm. Salbutamol 100mcg Inhaler (200MD) with 50mcl Aerosol Valve (Asthavent 100 mcg inhaler (200MD)) with 50 mcl Aerosol Valve) 1 No. 1. Salbutamol 0.02 gm. 2. Aerosol Valves 50mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 14.4 gm. Salbutamol 100mcg Inhaler (200MD) with 58mcl Aerosol Valve (Asthavent 100 mcg inhaler (200MD)) with 58 mcl Aerosol Valve) 1 No. 1. Salbutamol 0.02 gm. 2. Aerosol Valves 58mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 18.2 gm. Salbutamol 300mcg Inhaler (300MD) with 40mcl Aerosol Valve (Asthavent 100 mcg inhaler (300MD)) with 40 mcl Aerosol Valve) 1 No. 1. Salbutamol 0.03 gm. 2. Aerosol Valves 40mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 17.00 gm. Beclate 50mcg Inhaler (200MD) with 63mcl Aerosol Valve (Beclomethasone Dipropionate50 mcg inhaler (200MD)) with 63 mcl 1 No. 1. Beclomethasone Dipropionate 0.01 gm. 2. Aerosol Valves 63mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy
( )) Aerosol Valve) policy 4. Aluminium Can As per packing policy 5. 17.74 gm. 6. Ethanol 0.455 gm. Beclate 100mcg Inhaler (200MD) with 63mcl Aerosol Valve (Beclomethasone Dipropionate100 mcg inhaler (200MD)) with 63 mcl Aerosol Valve) 1 No. 1. Beclomethasone Dipropionate 0.02 gm. 2. Aerosol Valves 63mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 17.30 gm. 6. Ethanol 0.91 gm. Beclate 200mcg Inhaler (200MD) with 63mcl Aerosol Valve (Beclomethasone Dipropionate200 mcg inhaler (200MD)) with 63 mcl Aerosol Valve) 1 No. 1. Beclomethasone Dipropionate 0.04 gm. 2. Aerosol Valves 63mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 16.4 gm. 6. Ethanol 1.82 gm. Beclate 250mcg Inhaler (200MD) with 63mcl Aerosol Valve (Beclomethasone Dipropionate250 mcg inhaler (200MD)) with 63 mcl Aerosol Valve) 1 No. 1. Beclomethasone Dipropionate 0.05 gm. 2. Aerosol Valves 63mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 15.9 gm. 6. Ethanol 2.27 gm. The above norms have been ratified by NC subject to the following conditions: The quantity of HFA 134A Propellant Gas in the above norms is inclusive of 20% overages to compensate leakage, priming and non retrieval dose remaining inside the Can and and allowance for shot weight variation. However no wastage is claimed for APIs by the firm. The firm will maintain a separate record for the actual consumption of HFA 134A Propellant Gas and will pay duty on the surplus quantity of gas remained unutilized, if any. RA concerned may take further necessary action as per above decision of NC.
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Case No.:13/5/82ALC4/2011
Party Name:EMBIO LTD 31.07.2012 Status:Case Approved HQ File :01/82/050/00115/AM12/ RLA File :03/94/040/00009/AM12/ Lic.No/Date:0310627428 20.04.2011 Defer Date: Decision : In the light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/403/2011PI(Norms) dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Kg/kg PyrrolidinylLNorrephedrine Base or (1R,2S)Pyrrolidinyl Norrephedrine 1 kg 1. Benzaldehyde 3.24 2. Hydroxylamine HCL/Hydroxylamine Sulphate 1.71 3. Caustic Soda Lye 9.38 4. Oxalic Acid 2.00 5. EDTA 0.120 6. Methanol 3.15 7. Toluene 4.94 8. Potassium Hydroxide Flakes 2.78 9. Acetone 0.80 10. Activated Carbon 0.036 11 1,4 Dibromobutane 2.36 21
Case No.:14/5/82ALC4/2011
31.07.2012 Status:Case Approved HQ File :01/82/050/00116/AM12/ RLA File :03/94/040/00008/AM12/ Lic.No/Date:0310627429 20.04.2011 Defer Date: Decision : In the light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/403/2011PI(Norms) dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Kg/kg PyrrolidinylLNorrephedrine Base or (1R,2S)Pyrrolidinyl Norrephedrine 1 kg 1. Benzaldehyde 3.24 2. Hydroxylamine HCL/Hydroxylamine Sulphate 1.71 3. Caustic Soda Lye 9.38 4. Oxalic Acid 2.00 5. EDTA 0.120 6. Methanol 3.15 7. Toluene 4.94 8. 2.78 9. Acetone 0.80 10. Activated Carbon 0.036 11 1,4 Dibromobutane 2.36 RA may take appropriate action as per the decision of Norms Committee
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Case No.:32/6/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/00150/AM12/ RLA File :09/24/040/00037/AM12/ Lic.No/Date:0910046439 21.04.2011 Defer Date:30.08.2012 Decision : It was decided to again send a copy of application to Department of Pharmaceutical for their comments. Accordingly, the case was deferred for 30.8.2012. 23
Case No.:33/6/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/00151/AM12/ RLA File :09/24/040/00031/AM12/ Lic.No/Date:0910046440 21.04.2011 Defer Date:30.08.2012 24
Case No.:19/10/82ALC4/2011
Party Name:PLANET HERBS LIFE SCIENCES PVT.LTD. 31.07.2012 Status:Case Deferred HQ File :01/82/050/00278/AM12/ RLA File :61/24/040/00097/AM11/ Lic.No/Date:6110000608 03.05.2011 Defer Date:30.08.2012 Decision : It was decided to defer the case for 30.8.2012 for comments of DC(MSME). 25
Case No.:2/8/82ALC4/2011
31.07.2012 Status:Case Approved HQ File :01/82/050/00202/AM12/ RLA File :03/94/040/01025/AM11/ Lic.No/Date:0310629987 06.05.2011 Defer Date: Decision : In the personal Hearing held on 7.2.2012, the firm was requested to submit the revised application. On the basis of revised application submitted by the firm and in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/294/2011 PI(Norms) dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Kg/kg PyrrolidinylLNorephedrine HCL 1 kg 1. Benzaldehyde 3.14 2. Caustic Soda Lye 9.10 3. HAH/HAS 1.66 4 Oxalic Acid 1.94 5. Activated Carbon 0.035 6. Acetone 1.00 7. Caustic Pottash Flakes 2.165 8. Methanol 3.06 9 EDTA 0.116 10 Toluene 4.80 11 1 4 Dibromob tane 2 29
11 14 Dibromobutane 2.29 26
Case No.:43/8/82ALC4/2011
31.07.2012 Status:Case Approved HQ File :01/82/050/00243/AM12/ RLA File :03/94/040/01024/AM11/ Lic.No/Date:0310630508 10.05.2011 Defer Date: Decision : In the personal Hearing held on 7.2.2012, the firm was requested to submit the revised application On the basis of revised application submitted by the firm and in the light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/403/2011 PI(Norms) dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Kg/kg PyrrolidinylLNorrephedrine Base or (1R,2S)Pyrrolidinyl Norrephedrine 1 kg 1. Benzaldehyde 3.24 2. Hydroxylamine HCL/Hydroxylamine Sulphate 1.71 3. Caustic Soda Lye 9.38 4. Oxalic Acid 2.00 5. EDTA 0.120 6. Methanol 3.15 7. Toluene 4.94 8. 2.78 9. Acetone 0.80 10. Activated Carbon 0.036 11 1,4 Dibromobutane 2.36 27
Case No.:44/8/82ALC4/2011
31.07.2012 Status:Case Approved HQ File :01/82/050/00244/AM12/ RLA File :03/94/040/01023/AM11/ Lic.No/Date:0310630510 10.05.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/295/2011PI(Norms) dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Kg/kg LNorephedrine Base 1 kg 1. Benzaldehyde 5.22 2 HAH/HAS 2.76 3. Caustic Soda Lye 15.13 4. Oxalic Acid 3.16 5. EDTA 0.193 6. Methanol 5.08 7 Toluene 7 97
Toluene 7.97 8. 2.00 28
Case No.:36/12/82ALC4/2011
Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:14/82ALC4/2012 31.07.2012 Status:Case Deferred HQ File :01/82/050/00369/AM12/ RLA File :34/24/040/00016/AM12/ Lic.No/Date:3410030199 12.05.2011 Defer Date:30.08.2012 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/371/2011PI(Norms) dated 6.3.2012, it was decided to call from the firm the complete technical details as per Appendix 33 of the policy. Accordingly, the case was deferred for 30.8.2012. 29
Case No.:3/9/82ALC4/2011
31.07.2012 Status:Case Approved HQ File :01/82/050/00254/AM12/ RLA File :03/94/040/00120/AM12/ Lic.No/Date:0310631346 16.05.2011 Defer Date: Decision : In the personal Hearing held on 7.2.2012, the firm was requested to submit the revised application On the basis of revised application submitted by the firm and in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/295/2011 PI(Norms) dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Kg/kg LNorephedrine Base 1 kg 1. Benzaldehyde 5.22 2 HAH/HAS 2.76 3. Caustic Soda Lye 15.13 4. Oxalic Acid 3.16 5. EDTA 0.193 6. Methanol 5.08 7. Toluene 7.97 8. 2.00
Case No.:4/9/82ALC4/2011
31.07.2012 Status:Case Approved HQ File :01/82/050/00255/AM12/ RLA File :03/94/040/00121/AM12/ Lic.No/Date:0310631350 16.05.2011 Defer Date: Decision : In the personal Hearing held on 7.2.2012, the firm was requested to submit the revised application On the basis of revised application submitted by the firm and in the light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/403/2011 PI(Norms) dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty Sl No Import items Qty allowed
30 Export product Export Qty. Sl.No. Import items Qty. allowed Kg/kg PyrrolidinylLNorrephedrine Base or (1R,2S)Pyrrolidinyl Norrephedrine 1 kg 1. Benzaldehyde 3.24 2. Hydroxylamine HCL/Hydroxylamine Sulphate 1.71 3. Caustic Soda Lye 9.38 4. Oxalic Acid 2.00 5. EDTA 0.120 6. Methanol 3.15 7. Toluene 4.94 8. 2.78 9. Acetone 0.80 10. Activated Carbon 0.036 11 1,4 Dibromobutane 2.36 31
Case No.:1/10/82ALC4/2011
31.07.2012 Status:Case Approved HQ File :01/82/050/00260/AM12/ RLA File :03/94/040/00148/AM12/ Lic.No/Date:0310631875 19.05.2011 Defer Date: Decision : : In the personal Hearing held on 7.2.2012, the firm was requested to submit the revised application On the basis of revised application submitted by the firm and in the light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/297/2011 PI(Norms) dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Kg/kg LNorephedrine HCL 1 kg 1. Benzaldehyde 4.165 2. Hydroxylamine Hcl/Hydroxylamine Sulphate 2.208 3. Caustic Soda Lye 12.104 4. Oxalic Acid 2.528 5. EDTA 0.155 6. Methanol 4.50 7. 1.60 8. Toluene 5.94 9. Activated Carbon 0.030 10. Acetone 0.80
Case No.:2/10/82ALC4/2011
31.07.2012 Status:Case Approved HQ File :01/82/050/00261/AM12/ RLA File :03/94/040/00151/AM12/ Lic.No/Date:0310631883 19.05.2011 Defer Date: Decision : In the personal Hearing held on 7.2.2012, the firm was requested to submit the revised application On the basis of revised application submitted by the firm and in the light of written comments forwarded by Department of Pharmaceuticals vide their OM No 35011/403/2011
32 submitted by the firm and in the light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/403/2011 PI(Norms) dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Kg/kg PyrrolidinylLNorrephedrine Base or (1R,2S)Pyrrolidinyl Norrephedrine 1 kg 1. Benzaldehyde 3.24 2. Hydroxylamine HCL/Hydroxylamine Sulphate 1.71 3. Caustic Soda Lye 9.38 4. Oxalic Acid 2.00 5. EDTA 0.120 6. Methanol 3.15 7. Toluene 4.94 8. 2.78 9. Acetone 0.80 10. Activated Carbon 0.036 11 1,4 Dibromobutane 2.36 33
Case No.:41/10/82ALC4/2011
Party Name:HETERO LABS LIMITED 31.07.2012 Status:Case Approved HQ File :01/82/050/00300/AM12/ RLA File :09/24/040/00111/AM12/ Lic.No/Date:0910046916 26.05.2011 Defer Date: Decision : It was noticed that this case has already been approved in NC meeting no. 52/82 dated 27.3.2011. Hence the case was withdrawn. 34
Case No.:44/14/82ALC4/2011
Party Name:ONEIRO CHEMICALS LTD 31.07.2012 Status:Case Approved HQ File :01/82/050/00435/AM12/ RLA File :34/24/040/00037/AM12/ Lic.No/Date:3410030415 30.05.2011 Defer Date: Decision : In the light of earlier decision taken in meeting no. 49/82 dated 6.3.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed 2Chloromethyl3,5 Dimethyl4Methoxy Pyridine Hydrochloride 1 Kg. 1. 3,5 Lutidine 1.77 kg 2. Toluene 5.20 kg 3. Methanol 4.14 kg 4. Acetone 2.07 kg 5. Activated Carbon 0.100 kg 6. Ammonium Persulphates 2.43 kg RA concerned may take further necessary action as per above decision of NC.
35
Case No.:2/15/82ALC4/2011
Party Name:ACHARYA CHEMICALS 31.07.2012 Status:Case Deferred HQ File :01/82/050/00442/AM12/ RLA File :03/94/040/00130/AM12/ Lic.No/Date:0310633824 31.05.2011 Defer Date:30.08.2012 Decision :It was decided to give final reminder to the firm to furnish the following information within 15 days, failing which the case would be closed: End use of the export product In case it is drug, a copy of Drug Manufacturing License. Accordingly, the case was deferred for 30.8.2012. 36
Case No.:25/19/82ALC4/2011
Party Name:VIVIMED LABS LIMITED 31.07.2012 Status:Case Rejected HQ File :01/82/050/00539/AM12/ RLA File :09/24/040/00085/AM12/ Lic.No/Date:0910046996 06.06.2011 Defer Date: Decision : It was decided to close the case as the firm has not furnished the information despite repeated reminders. 37
Case No.:20/14/82ALC4/2012
Party Name:RANBAXY LABORATORIES LTD 31.07.2012 Status:Case Deferred HQ File :01/82/050/00397/AM13/ RLA File :05/24/040/00082/AM12/ Lic.No/Date:0510292925 10.06.2011 Defer Date:30.08.2012 38
Case No.:27/16/82ALC4/2011
Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:14/82ALC4/2012 31.07.2012 Status:Case Deferred HQ File :01/82/050/00485/AM12/ RLA File :34/24/040/00039/AM12/ Lic.No/Date:3410030563 10.06.2011 Defer Date:30.08.2012 Decision : It was decided to give a last reminder to the firm to furnish the following information within 15 days failing which the case would be closed: Complete and balanced chemical reaction with Mol. Wt. and molar requirement of each input % yield on molar basis for each step. Material balance for entire process. Requirement and Recovery of solvent at each step of manufacturing process. Accordingly, the case was deferred for 30.8.2012.
Case No.:36/14/82ALC4/2011
Party Name:SHASUN PHARMACEUTICALS Status:Case
39 LIMITED 31.07.2012 Approved HQ File :01/82/050/00427/AM12/ RLA File :04/24/040/00069/AM12/ Lic.No/Date:0410125143 20.06.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/231/2012PI (Norms) dated 24.7.2012, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg Ibuprofen (Sodium Metal Route) 1 kg 1. Isobutyl Benzene 0.952 2. Acetyl Chloride 0.714 3. Isopropyl Alcohol 0.952 4. Sodium Metal 0.285 5. Monochloro Acetic Acid 1.25 6. Isopropyl Alcohol 1.00 7. Sodium Dichromate 0.63 40
Case No.:35/19/82ALC4/2011
Party Name:NECTAR LIFESCIENCES LIMITED, 31.07.2012 Status:Case Deferred HQ File :01/82/050/00549/AM12/ RLA File :22/24/040/00022/AM12/ Lic.No/Date:2210011532 28.06.2011 Defer Date:30.08.2012 Decision : It was decided to send a copy of application to Department of Pharmaceuticals for their comments. Accordingly, the case was deferred for 30.8.2012. 41
Case No.:16/20/82ALC4/2011
Party Name:SAURAV CHEMICALS LTD, 31.07.2012 Status:Case Approved HQ File :01/82/050/00578/AM12/ RLA File :22/24/040/00024/AM12/ Lic.No/Date:2210011568 01.07.2011 Defer Date: Decision : It was noted that this case has already been approved in NC meeting no. 13 dated 17.7.2012. Therefore, the case was withdrawn. 42
Case No.:1/24/82ALC4/2011
Party Name:PARABOLIC DRUGS LTD., 31.07.2012 Status:Case Deferred HQ File :01/82/050/00662/AM12/ RLA File :05/24/040/00150/AM12/ Lic.No/Date:0510298306 01.08.2011 Defer Date:30.08.2012 Decision : It was decided to call from the firm the technical details in Appendix 33 of the Policy. The case was deferred for 30.8.2012. 43
Case No.:2/24/82ALC4/2011
Party Name:PARABOLIC DRUGS LTD., 31.07.2012 Status:Case Deferred HQ File :01/82/050/00663/AM12/ RLA File :05/24/040/00149/AM12/ Lic.No/Date:0510298304 01.08.2011 Defer Date:30.08.2012
Decision : It was decided to call from the firm the technical details in Appendix 33 of the Policy. The case was deferred for 30.8.2012. 44
Case No.:3/24/82ALC4/2011
Party Name:PARABOLIC DRUGS LTD., 31.07.2012 Status:Case Deferred HQ File :01/82/050/00664/AM12/ RLA File :05/24/040/00083/AM12/ Lic.No/Date:0510298301 01.08.2011 Defer Date:30.08.2012 Decision : It was decided to call from the firm the technical details in Appendix 33 of the Policy. The case was deferred for 30.8.2012. 45
Case No.:12/25/82ALC4/2011
Party Name:GOPINATH CHEMTECH LTD., 31.07.2012 Status:Case Approved HQ File :01/82/050/00679/AM12/ RLA File :08/24/040/00107/AM12/ Lic.No/Date:0810102095 03.08.2011 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/60/2012Ch II dated 12.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed 1Amino2,5 Dimethoxy4 Sulphananilide 1 kg 1. Hydroquinone 1.990 kg 2. Caustic Soda Flakes or Caustic Soda Lye (on 100% real basis) 8.194 kg 3. Soda Ash 2.500 kg 4. Aniline Oil 0.782 kg 46
Case No.:39/31/82ALC4/2011
Party Name:SAURAV CHEMICALS LTD, 31.07.2012 Status:Case Deferred HQ File :01/82/050/00865/AM12/ RLA File :22/24/040/00039/AM12/ Lic.No/Date:2210011843 01.09.2011 Defer Date:30.08.2012 47
Case No.:16/32/82ALC4/2011
Party Name:AUCTUS PHARMA LIMITED 31.07.2012 Status:Case Approved HQ File :01/82/050/00897/AM12/ RLA File :09/24/040/00257/AM12/ Lic.No/Date:0910048616 06.09.2011 Defer Date: Decision : It was noted that this case has already been approved in NC meeting No. 12 held on 3.7.2012. Hence, the case was withdrawn.
Case No.:15/32/82ALC4/2011
Party Name:RAMPEX LABS PVT. LTD. 31.07.2012 Status:Case Approved
48 HQ File :01/82/050/00896/AM12/ RLA File :09/24/040/00273/AM12/ Lic.No/Date:0910048689 09.09.2011 Defer Date: Decision : It was noted that this case has already been approved in NC meeting No. held on 3.7.2012. Hence, the case was withdrawn 49
Case No.:28/32/82ALC4/2011
Party Name:RAMPEX LABS PVT. LTD. 31.07.2012 Status:Case Approved HQ File :01/82/050/00909/AM12/ RLA File :09/24/040/00272/AM12/ Lic.No/Date:0910048688 09.09.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/53/2012PI (Norms), it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg 6Fluoro3,4 Dihydro2H1 Benzopyran2 Carboxylic Acid/Chroman Acid 1 kg 1. 4Fluoro Phenol (Para Fluoro Phenol) 1.076 2. Acetic Acid 9.28 3. Chloroform 2.54 4. Diethyl Oxalate 1.16 5. Methanol 10.27 6. Toluene 1.22 7. 10% Palladium on Carbon (50% Wet) 0.0935 50
Case No.:39/32/82ALC4/2011
Party Name:NECTAR LIFESCIENCES LIMITED, 31.07.2012 Status:Case Approved HQ File :01/82/050/00920/AM12/ RLA File :22/24/040/00046/AM12/ Lic.No/Date:2210011928 22.09.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/21/2012PI (Norms) dated 13.6.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg Cefotaxime Sodium Sterile 1 kg 1. Cefotaxime Acid 0.989 2. Ethyl Acetate 3.16 3. Methanol 0.44 4. Triethylamine (TEA) 0.178 5 Eno Carbon 0.031 6. Sod2Ethyl Hexanoate 0.44 7. Methyl Iso Butyl Ketone 0.25
51
Case No.:25/32/82ALC4/2011
Party Name:RANBAXY LABORATORIES LTD 31.07.2012 Status:Case Approved HQ File :01/82/050/00906/AM12/ RLA File :05/24/040/00194/AM12/ Lic.No/Date:0510304240 29.09.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/52/2012PI (Norms) dated 4.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg pNitrobenzyl (1R,5R,6S)6[(1R)1 Hydroxyethyl]2 [(Diphenylphosphone) Oxy]1 Methylcarbapen2EM 3Carboxylate 1 kg 1. (3R,4R)4Acetoxy3(® (Tert Butyldimethylsilyloxy) Ethyl2Azetidinone 1.38 2. Acetone 0.827 3. Dilsopropyl ethylamine 0.313 4/ Diphenyl Chlorophosphate 0.595 5. Imidazole 0.675 6. Magnesium Chloride, Anhydrous 0.259 7. Methanol 2.06 8. Methyl Iso Butyl Ketone 1.25 9. Toluene 1.77 10. Triethylamine 1.16 52
Case No.:16/35/82ALC4/2011
Party Name:HIRAN ORGOCHEM LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/00943/AM12/ RLA File :03/94/040/00474/AM12/ Lic.No/Date:0310657248 30.09.2011 Defer Date:30.08.2012 Decision : It was decided to call from the firm the technical details in Appendix 33 of the Policy. Accordingly, the case was deferred for 30.8.2012.
Case No.:2/35/82ALC4/2011
31.07.2012 Status:Case Approved HQ File :01/82/050/00929/AM12/ RLA File :03/94/040/00572/AM12/ Lic.No/Date:0310658087 05.10.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/295/2011PI(Norms) dated 31 7 2012 it was decided to ratify norms under Para 4 7 of HBP v1 as per details given below or as applied by the firm whichever is less:
53 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Kg/kg LNorephedrine Base 1 kg 1. Benzaldehyde 5.22 2 HAH/HAS 2.76 3. Caustic Soda Lye 15.13 4. Oxalic Acid 3.16 5. EDTA 0.193 6. Methanol 5.08 7. Toluene 7.97 8. 2.00 54
Case No.:24/35/82ALC4/2011
Party Name:LUPIN LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/00951/AM12/ RLA File :03/95/040/00562/AM12/ Lic.No/Date:0310658391 07.10.2011 Defer Date:30.08.2012 Decision : It was decided to send a copy of application to Department of Pharmaceuticals for their comments. Accordingly, the case was deferred for 30.8.2012. 55
Case No.:9/35/82ALC4/2011
Party Name:UNITED BIOTECH PVT.LTD. 31.07.2012 Status:Case Deferred HQ File :01/82/050/00936/AM12/ RLA File :05/24/040/00226/AM12/ Lic.No/Date:0510304974 11.10.2011 Defer Date:30.08.2012 Decision:It was decided to defer the case for 30.8.2012 for comments of D/o Pharmaceuticals. 56
Case No.:7/31/82ALC4/2011
31.07.2012 Status:Case Approved HQ File :01/82/050/00833/AM12/ RLA File :03/94/040/00612/AM12/ Lic.No/Date:0310659475 13.10.2011 Defer Date: Decision : : In the personal Hearing held on 7.2.2012, the firm was requested to submit the revised application On the basis of revised application submitted by the firm and in the light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/297/2011 PI(Norms) dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Kg/kg LNorephedrine HCL 1 kg 1. Benzaldehyde 4.165 2. Hydroxylamine Hcl/Hydroxylamine Sulphate 2.208 3. Caustic Soda Lye 12.104 4. Oxalic Acid 2.528
EDTA 0.155 6. Methanol 4.50 7. 1.60 8. Toluene 5.94 9. Activated Carbon 0.030 10. Acetone 0.80 57
Case No.:8/31/82ALC4/2011
31.07.2012 Status:Case APPROVED HQ File :01/82/050/00834/AM12/ RLA File :03/94/040/00611/AM 12/ Lic.No/Date:0310659491 13.10.2011 Defer Date Decision : : In the personal Hearing held on 7.2.2012, the firm was requested to submit the revised application On the basis of revised application submitted by the firm and in the light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/297/2011 PI(Norms) dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Kg/kg LNorephedrine HCL 1 kg 1. Benzaldehyde 4.165 2. Hydroxylamine Hcl/Hydroxylamine Sulphate 2.208 3. Caustic Soda Lye 12.104 4. Oxalic Acid 2.528 5. EDTA 0.155 6. Methanol 4.50 7. 1.60 8. Toluene 5.94 9. Activated Carbon 0.030 10. Acetone 0.80 58
Case No.:11/41/82ALC4/2011
Party Name:INDIA GLYCOLS LTD., 31.07.2012 Status:Case Deferred HQ File :01/82/050/01012/AM12/ RLA File :05/23/040/00237/AM12/ Lic.No/Date:0510305501 17.10.2011 Defer Date:30.08.2012 Decision : It was decided to defer the case for 30.8.2012 for comments of Department of Chemicals and Petrochemicals. 59
Case No.:25/42/82ALC4/2011
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. 31.07.2012 Status:Case Approved HQ File :01/82/050/01060/AM12/ RLA File :03/95/040/00462/AM12/ Lic.No/Date:0310662886 02.11.2011 Defer Date:
Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/62/2010Ch. II dated 13.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed SUR 742 [1,2,4] Triazole[1,5 a]pyridine6carbonitrile,8[{2 (dubutylamino)4phenyl5 thiazolyl]2(1 ethylpentyl)5,8dihydro7 methyl5oxo 1 kg 1. 2Ethylhexanoic Acid 2.395 kg 2. Hydrazine Hydrate 99100% 0.707 kg 3. Ethyl Cyano Acetate 1.757 kg 4. 3Amino Crotononitrile 1.625 kg 5. Triethylamine 1.396 kg 6. Thiourea 1.792 kg 7. Acetone 4.450 kg 8. Sodium Hydroxide Pellets 22.500 kg 9. Methylene Dichloride 6.564 kg 10. Sulfolane 2.268kg 11 BOC Anhydride 1.902 kg 12 THF 3.800 kg 13 NHeptane 6.365 kg 14 Triflic Acid 1.425 kg 15 Trifluoro Acetic Acid 2.850 kg 16 2Methyl Tetra Hydro Furan 2.860 kg 60
Case No.:28/41/82ALC4/2011
Party Name:LIV MEDICA PRODUCTS PVT. LTD. 31.07.2012 Status:Case Deferred HQ File :01/82/050/01029/AM12/ RLA File :04/24/040/00210/AM12/ Lic.No/Date:0410130168 09.11.2011 Defer Date:30.08.2012 Decision : It was decided to defer the case for 30.8.2012 for comments of Department of Industrial Policy and Promotion. 61
Case No.:3/45/82ALC4/2011
Party Name:ENCUBE ETHICALS PVT LTD 31.07.2012 Status:Case Deferred HQ File :01/82/050/01180/AM12/ RLA File :03/94/040/00691/AM12/ Lic.No/Date:0310664617 14.11.2011 Defer Date:30.08.2012 Decision : It was decided to defer the case for 30.8.2012 for comments of DC(MSME). 62
Case No.:4/45/82ALC4/2011
Party Name:KOPRAN LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01181/AM12/ RLA File :03/94/040/00521/AM12/ Lic.No/Date:0310664771 14.11.2011 Defer Date:30.08.2012 63
Case No.:4/9/82ALC4/2012
Party Name:ESTEEM INDUSTRIES PVT. LTD, 31 07 2012 Status:Case D f d
31.07.2012 Deferred HQ File :01/82/050/00249/AM13/ RLA File :17/24/040/00067/AM12/ Lic.No/Date:1710004590 15.11.2011 Defer Date:30.08.2012 Decision : It was decided to give l reminder to the firm to furnish the requisite information within 15 days failing which the case would be closed: Balanced chemical reaction showing all the reactants, product and by product with their molecular formula and molecular weight. Stagewise % yield on molecular weight basis alongwith justification supported with authentic/printed technical literature. Authentic/printed technical literature in support of % yield or norms applied for import. Complete material balance. The % active content of export item and composition of export item. . Accordingly, the case was deferred for 30.6.2012 64
Case No.:31/49/82ALC4/2011
Party Name:SMILAX LABORATORIES LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01340/AM12/ RLA File :09/24/040/00332/AM12/ Lic.No/Date:0910049719 16.11.2011 Defer Date:30.08.2012 65
Case No.:27/49/82ALC4/2011
Party Name:ANDHRA ORGANICS LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01336/AM12/ RLA File :09/24/040/00344/AM12/ Lic.No/Date:0910049777 18.11.2011 Defer Date:30.08.2012 Decision : It was decided to send the application to Department of Pharmaceuticals for their comments. Accordingly, the case was deferred for 30.8.2012. 66
Case No.:31/45/82ALC4/2011
Party Name:MYLAN LABORATORIES LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01208/AM12/ RLA File :09/24/040/00348/AM12/ Lic.No/Date:0910049778 18.11.2011 Defer Date:30.08.2012 Decision : It was decided to defer the case for 30.8.2012 for comments of Department of Pharmaceuticals 67
Case No.:2/36/82ALC4/2011
Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:14/82ALC4/2012 31.07.2012 Status:Case Approved HQ File :01/82/050/00959/AM12/ RLA File :31/83/040/00170/AM12/ Lic.No/Date:3110051562 21 11 2011 Defer Date:
21.11.2011 Decision : It was noted that this case has already been approved in 12th meeting of the NC held on 3.7.2012. Hence, the case was withdrawn. 68
Case No.:33/41/82ALC4/2011
Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01034/AM12/ RLA File :52/24/040/00036/AM12/ Lic.No/Date:5210037111 21.11.2011 Defer Date:30.08.2012 Decision : Department of Chemicals and Petrochemicals vide their letter No. 14010/45/2010Ch. II dated 18th July 2012 has requested the firm to furnish the following information: 1. Manufacturing process in brief 2. Balanced chemical reaction showing all the reactants, product and by product with their molecular formula and molecular weight. 3. Complete material balance with the formation of isomers. 4. Stagewise % yield on molecular weight basis alongwith justification supported with authentic/printed technical literature. 5. Quanity of solvents charged, recovered and loss in process for per kg of export item along with justification. 6. Production of export item for the past 3 years and corresponding consumption of each input duly certified by C.A 7. Photocopy of the earlier norms fixed by ALC for same export item in the recent past. 8. Detail of isomers/byproducts formed during the process and its recovered in terms of quantity and value for per kg of export item. It was decided to remind the firm to furnish the above information within 15 days or the case would be closed. Accordingly, the case was deferred for 30.8.2012. 69
Case No.:29/49/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01338/AM12/ RLA File :09/24/040/00379/AM12/ Lic.No/Date:0910049906 24.11.2011 Defer Date:30.08.2012 70
Case No.:63/46/82ALC4/2011
Party Name:ANDHRA ORGANICS LIMITED 31.07.2012 Status:Case Approved HQ File :01/82/050/01279/AM12/ RLA File :09/24/040/00387/AM12/ Lic.No/Date:0910049937 29.11.2011 Defer Date: Decision : In the light of earlier decision taken in meeting no. 13/82 dated 17.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed D+Ester[(2S,3S)‐2‐ Hydroxy‐3‐(2‐ aminophenylthio)‐3‐(4‐ methoxyphenyl)‐propionic acid methyl ester] 1 kg 1. Para Cresol 2.4375 kg/kg 2. Causퟣ�c Soda Flakes 0.90 kg/kg 3. Toluene 1.0125 kg/kg 4 M th l Chl 1 532 kg/kg
Methyl Chloro Acetate 1.532 kg/kg 5. Banzothiazole 2.09 kg/kg 6. Methanol 3.617 kg/kg 7. L‐Tartaric Acid 0.280 kg/kg RA concerned may take further necessary action as per above decision of NC 71
Case No.:33/49/82ALC4/2011
Party Name:DR REDDYS LABORATORIES LIMITED 31.07.2012 Status:Case Approved HQ File :01/82/050/01342/AM12/ RLA File :09/24/040/00396/AM12/ Lic.No/Date:0910049978 30.11.2011 Defer Date: Decision : It was decided in the meeting to advice RA to fix norms of all the import items as per prevalent packing policy. 72
Case No.:7/45/82ALC4/2011
Party Name:SANO MEDICAL KITS PVT. LTD., 31.07.2012 Status:Case Deferred HQ File :01/82/050/01184/AM12/ RLA File :04/24/040/00244/AM12/ Lic.No/Date:0410131205 01.12.2011 Defer Date:30.08.2012 Decision : In the light of written comments received from Department of Industrial Policy and Promotion vide their note dated 30.7.2012 to ask the firm to furnish the following information: A declaration, indicating quantity/number and specification including sizes (if applicable) of each imported item which are containing in export item separately for each. Wastage of imported items, if any, with complete justification. Accordingly, the case was deferred for 30.8.2012. 73
Case No.:6/29/85ALC3/2011
Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 31.07.2012 Status:Case Deferred HQ File :01/85/050/00163/AM12/ RLA File :04/24/040/00239/AM12/ Lic.No/Date:0410131226 02.12.2011 Defer Date:30.08.2012 Decision : It was decided to remind RA. Chennai to furnish hard copy of the application without any further delay and on receipt the same may be sent to Department of Pharmaceuticals. Accordingly, the case was deferred for 30.8.2012. 74
Case No.:54/46/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01270/AM12/ RLA File :09/24/040/00398/AM12/ Lic.No/Date:0910050048 05.12.2011 Defer Date:30.08.2012
p 75
Case No.:34/49/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01343/AM12/ RLA File :09/24/040/00358/AM12/ Lic.No/Date:0910050099 08.12.2011 Defer Date:30.08.2012 76
Case No.:82/46/82ALC4/2011
Party Name:VIVIN LABORATORIES PRIVATE LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01298/AM12/ RLA File :09/24/040/00127/AM12/ Lic.No/Date:0910050138 09.12.2011 Defer Date:30.08.2012 Decision : It was decided to defer the case for 30.8.2012 for comments of Department of Chemicals and Petrochemicals. 77
Case No.:1/39/82ALC4/2011
Party Name:SALVI CHEMICAL INDUSTRIES LIMITED 31.07.2012 Status:Case Approved HQ File :01/82/050/00993/AM12/ RLA File :03/95/040/00718/AM12/ Lic.No/Date:0310670262 13.12.2011 Defer Date: Decision :In consultation with the technical member from Department of Pharmaceuticals and on the basis of the past decision taken in the meeting, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Ferrous Fumarate BP (Purity not less than 93%) 1 Kg. 1. Fumaric Acid (Technical Grade) 0 769 kg 2. Ferrous Sulphate 1.78.l kg 3. Soda Ash 0.065 kg 78
Case No.:2/39/82ALC4/2011
Party Name:BILCARE LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/00994/AM12/ RLA File :31/83/040/00167/AM12/ Lic.No/Date:3110051868 13.12.2011 Defer Date:30.08.2012 79
Case No.:23/45/82ALC4/2011
Party Name:SUTURES INDIA PRIVATE LIMITED, 31.07.2012 Status:Case Deferred HQ File :01/82/050/01200/AM12/ RLA File :07/24/040/00341/AM12/ Lic.No/Date:0710084630 13.12.2011 Defer Date:30.08.2012 Decision : It was decided to defer the case for 30.8.2012 for comments of Department of Industrial Policy and Promotion. 80
Case No.:23/46/82ALC4/2011
Party Name:ROYAL PHARMA Status:Case
31.07.2012 Approved HQ File :01/82/050/01239/AM12/ RLA File :03/95/040/00738/AM12/ Lic.No/Date:0310670268 13.12.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/180/2012PI(Norms) dated 24.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Bicalutamide Sulfide Chemical Name: N[4Cyano3 (Trifluoro Methyl) Phenyl]3[(4 Flurophenyl thio)]2Hydroxy2 Methyl Propionalide 1 kg 1. N[4Cyano3(Trifluoro Methyl)phenyl] Methacrylamide 0.80 2. 4Flurothiopehnol 0.40 81
Case No.:8/45/82ALC4/2011
Party Name:SHASUN PHARMACEUTICALS LIMITED 31.07.2012 Status:Case Approved HQ File :01/82/050/01185/AM12/ RLA File :04/24/040/00253/AM12/ Lic.No/Date:0410131573 13.12.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/205/2012PI(Norms) dated 24.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg ®(+)2Carbomethoxy3 Tropinone Bitartrate[®(+)2CMT BT] 1 kg 1. 3Tropinone 3.56 2. LTartaric Acid 1.92 3. Isopropyl Alcohol 2.88 4. Acetone 2.36 5. Methanol 9.97 82
Case No.:24/46/82ALC4/2011
Party Name:ASHISH LIFE SCIENCE PVT.LTD. 31.07.2012 Status:Case Deferred HQ File :01/82/050/01240/AM12/ RLA File :03/94/040/00737/AM12/ Lic.No/Date:0310670672 14.12.2011 Defer Date:30.08.2012 Decision : It was decided to give final reminder to the firm to furnish the information requested for in minutes dated 14.2.2012, within 15 days failing which the case would be closed. 83
Case No.:74/46/82ALC4/2011
Party Name:HETERO DRUGS LIMITED, 31.07.2012 Status:Case Approved HQ File :01/82/050/01290/AM12/ RLA File :09/24/040/00421/AM12/ Lic.No/Date:0910050231 14.12.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No 35011/241/2012 PI(Norms) dated
Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/241/2012PI(Norms) dated 24.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Lercanidipine Hydrochloride 1 kg 1. 1[(3,3Diphenylpropyl)methyl amino]2methyl2propanol 1.35 2. 2,6Dimethyl5methoxycarbonyl4 (3nitrophenyl)1,4dihydro pyridine 3carboxylic acid 1.51 3. Trimethyl chlorosilane 0.594 83
Case No.:81/46/82ALC4/2011
Party Name:HETERO DRUGS LIMITED, 31.07.2012 Status:Case Approved HQ File :01/82/050/01297/AM12/ RLA File :09/24/040/00422/AM12/ Lic.No/Date:0910050232 14.12.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/202/2012PI(Norms) dated 24.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Lisinopril 1 kg 1. 3Benxoyl acrylic acid ethyl ester 1.77 2. N6TrifluoroacetylLLysine 1.231 3 Lithium hydroxide 0.455 4. LProline 0.927 5. N,NCarbonyldiimidazole 0.400 6. Toluene 6.20 7. Acetone 7.00 8. Methanol 1.00 9. Isopropyl alcohol 1.37 10. Methylene chloride 3.43 85
Case No.:59/46/82ALC4/2011
Party Name:INCHEM LABORATORIES PRIVATE LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01275/AM12/ RLA File :09/24/040/00413/AM12/ Lic.No/Date:0910050238 15.12.2011 Defer Date:30.08.2012 86
Case No.:2/40/82ALC4/2011
Party Name:FDC LTD 31.07.2012 Status:Case Approved HQ File :01/82/050/00998/AM12/ RLA File :03/94/040/00819/AM12/ Lic.No/Date:0310671854 20.12.2011 Defer Date:
Decision : It was noted that this case has already been approved in meeting no. 12 held on 3.7.2012. Hence the case was withdrawn. 87
Case No.:2/9/82ALC4/2012
Party Name:GRAND ORGANICS PVT.LTD. 31.07.2012 Status:Case Approved HQ File :01/82/050/00247/AM13/ RLA File :17/24/040/00009/AM11/ Lic.No/Date:1710004681 20.12.2011 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their note dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Product229 (Amino Ethyl Ethanol Amine) (Appearance at 25 deg. C: Clear liquid, Assay: Min. 99.5% Moisture: Max 0.2%) 1 kg 1. Aminoethyl Ethanol Amine (Appearance at 25 deg C: Clear Liquid) 1.005 kg 88
Case No.:3/9/82ALC4/2012
Party Name:GRAND ORGANICS PVT.LTD. 31.07.2012 Status:Case Approved HQ File :01/82/050/00248/AM13/ RLA File :17/24/040/00047/AM09/ Lic.No/Date:1710004679 20.12.2011 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/46/2012Ch. II dated 13.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed ProductETH2702 (Dipropylene Glycol Lauryl Myristyl Ether) (Colourless clear liquid) 1 kg 1 Lauryl Myristyl Alcohol (Colourless clear insoluble liquid) 0.623 kg 2. Propylene Oxide (colourless liquid) 0.376 kg RA may take appropriate action as per the decision of Norms Committee. 89
Case No.:56/14/82ALC4/2012
Party Name:GRAND ORGANICS PVT.LTD. 31.07.2012 Status:Case Deferred HQ File :01/82/050/00433/AM13/ RLA File :17/24/040/00048/AM09/ Lic.No/Date:1710004680 20.12.2011 Defer Date:30.08.2012 Decision : It was decided to send again a copy of application to Department of Chemicals and Petrochemicals for their comments. Accordingly, the case was deferred for 30.8.2012. 90
Case No.:30/46/82ALC4/2011
Party Name:DSM ANTIINFECTIVES INDIA LTD 31.07.2012 Status:Case Approved HQ File :01/82/050/01246/AM12/ RLA File :22/24/040/00076/AM12/ Lic.No/Date:2210012341 22.12.2011 Defer Date: D i i I h li h f i i d f D f Ph i l id h i U O N 35011/166/2012 PI(N ) d d
Decision : In the light of written comments received from Department of Pharmaceuticals vide their U.O No. 35011/166/2012PI(Norms) dated 24.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Amoxycillin Trihydrate through Pen G Route through Enzymatic Route 1 kg 1. Penicillin G Potassium 1st Crystal 1.664 BOU/kg 2. Formidase Enzyme 0.005 kg/kg 3. Methanol 0.002 4. D()PHydroxy phenyl glycine methyl ester 0.608 RA may take appropriate action as per the decision of NC. 91
Case No.:4/40/82ALC4/2011
Party Name:DEEPAK NITRITE LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01000/AM12/ RLA File :31/83/040/00137/AM12/ Lic.No/Date:3110052056 22.12.2011 Defer Date:23.08.2012 Decision : It was decided to defer the case for 23.8.2012 for comments of Department of Chemicals and Petrochemicals. 92
Case No.:46/49/82ALC4/2011
Party Name:ANDHRA ORGANICS LIMITED 31.07.2012 Status:Case Approved HQ File :01/82/050/01355/AM12/ RLA File :09/24/040/00418/AM12/ Lic.No/Date:0910050347 22.12.2011 Defer Date: Decision : In the light of earlier decision taken in meeting no. 13/82 dated 17.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed D+Ester[(2S,3S)2 Hydroxy3(2 aminophenylthio)3(4 methoxyphenyl)propionic acid methyl ester] 1 kg 1. Para Cresol 2.4375 kg/kg 2. Caustic Soda Flakes 0.90 kg/kg 3. Toluene 1.0125 kg/kg 4. Methyl Chloro Acetate 1.532 kg/kg 5. Banzothiazole 2.09 kg/kg 6. Methanol 3.617 kg/kg 7. LTartaric Acid 0.280 kg/kg RA concerned may take further necessary action as per above decision of NC 93
Case No.:1/47/82ALC4/2011
Party Name:BROOKS LABORATORIES LTD., 31.07.2012 Status:Case Deferred HQ File :01/82/050/01301/AM12/ RLA File :22/24/040/00067/AM12/ Lic.No/Date:2210012351 Defer
23.12.2011 Date:30.08.2012 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/237/2012PI dated 23.7.2012, it was decided to call from the firm the following technical details: Copy of relevant Drug Manufacturing Licence. Copy of Master Batch Formula duly certified by Quality Control Incharge. Accordingly, the case was deferred for 30.8.2012. 94
Case No.:2/47/82ALC4/2011
Party Name:BROOKS LABORATORIES LTD., 31.07.2012 Status:Case Deferred HQ File :01/82/050/01302/AM12/ RLA File :22/24/040/00066/AM12/ Lic.No/Date:2210012352 23.12.2011 Defer Date:30.08.2012 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/237/2012PI dated 23.7.2012, it was decided to call from the firm the following technical details: Copy of relevant Drug Manufacturing Licence. Copy of Master Batch Formula duly certified by Quality Control Incharge. Accordingly, the case was deferred for 30.8.2012. 95
Case No.:14/46/82ALC4/2011
Party Name:STAR DRUGS & RESEARCH LABS LTD 31.07.2012 Status:Case Deferred HQ File :01/82/050/01230/AM12/ RLA File :04/24/040/00242/AM12/ Lic.No/Date:0410132171 27.12.2011 Defer Date:30.08.2012 96
Case No.:15/46/82ALC4/2011
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 31.07.2012 Status:Case Deferred HQ File :01/82/050/01231/AM12/ RLA File :04/24/040/00259/AM12/ Lic.No/Date:0410132173 27.12.2011 Defer Date:30.08.2012 97
Case No.:4/46/82ALC4/2011
Party Name:AMI LIFESCIENCES P LTD 31.07.2012 Status:Case Deferred HQ File :01/82/050/01220/AM12/ RLA File :34/24/040/00189/AM12/ Lic.No/Date:3410032719 27.12.2011 Defer Date:30.08.2012 d id d d f h f f f f h i l
98
Case No.:3/41/82ALC4/2011
Party Name:RUSAN PHARMA LTD. 31.07.2012 Status:Case Deferred HQ File :01/82/050/01004/AM12/ RLA File :03/95/040/00803/AM12/ Lic.No/Date:0310673724 30.12.2011 Defer Date:30.08.2012 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/186/2012PI (norms) dated 23.7.2012, it was decided to call from the firm the complete technical details as per Appendix 33. Accordingly, the case was deferred for 30.8.2012. 99
Case No.:5/41/82ALC4/2011
Party Name:SOHAN HEALTHCARE PVT. LTD 31.07.2012 Status:Case Deferred HQ File :01/82/050/01006/AM12/ RLA File :31/83/040/00195/AM12/ Lic.No/Date:3110052178 30.12.2011 Defer Date: 30.8.2012 100
Case No.:5/45/82ALC4/2011
Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01182/AM12/ RLA File :03/94/040/00755/AM12/ Lic.No/Date:0310674056 02.01.2012 Defer Date:30.08.2012 Decision : It was noticed that Department of Chemicals and Petrochemicals vide their letter No. 14010/90/2011Ch. 2 dated 7.5.2012 has requested the firm to furnish the following information : Yield obtained in each step supported with authentic technical literature. Detailed calculations of arriving at the norms applied for. Central Excise Certificate certifying production of Hambet (7Acetyl1,2,3,4.5.6.7.8Octahydro I, 1,6,7 – Tetramethyl Naphthalne) achieved in the last three years and corresponding consumption of different raw materials. However, the firm has not furnished the information till data. It was decided to remind the firm to furnish information within 15 days failing which the case would be closed. Accordingly, the case was deferred for 30.8.2012. 101
Case No.:16/29/85ALC3/2011
Party Name:S.R.S.PHARMACEUTICALS PVT. LTD. 31.07.2012 Status:Case Deferred HQ File :01/85/050/00173/AM12/ RLA File :03/95/040/00831/AM12/ Lic.No/Date:0310674968 05.01.2012 Defer Date:30.08.2012 Decision : It was decided to remind the firm to furnish information sought vide minutes dated 12.1.2012 within 15 days failing which the case would be closed. The case was deferred for 30.8.2012.
102
Case No.:20/51/82ALC4/2011
Party Name:POLYDRUG LABORATORIES PVT.LTD. 31.07.2012 Status:Case Approved HQ File :01/82/050/01413/AM12/ RLA File :03/95/040/00819/AM12/ Lic.No/Date:0310674929 05.01.2012 Defer Date: Decision : In the light of earlier decision taken in meeting No. 3/82 dated 20.4.2010, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as approved by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Ferrous Fumarate Tech Spec.: Pharmacoepial Grade 1 kg 1. Fumaric Acid 0.769 kg 103
Case No.:14/45/82ALC4/2011
Party Name:DIVIS LABORATORIES LTD., 31.07.2012 Status:Case Approved HQ File :01/82/050/01191/AM12/ RLA File :09/24/040/00468/AM12/ Lic.No/Date:0910050661 06.01.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/258/2012PI(Norms) dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg 2 {[(Benzyloxy)carbonyl]amino}2 (3hydroxy adamantan1yl)acetic acid 1 kg 1. 1Adamantaneacetic Acid 5.55 2. (1R2S)()2Amino1,2 Diphenylethanol 3.44 3. Tetra Hydrofuran 13.47 104
Case No.:47/1/82ALC4/2012
Party Name:SUVEN LIFE SCIENCES LIMITED 31.07.2012 Status:Case Approved HQ File :01/82/050/01489/AM12/ RLA File :09/24/040/00477/AM12/ Lic.No/Date:0910050664 06.01.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/260/2012PI(Norms) dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg 2,4Dimethyl Thiophenol 1 kg 1 Meta Xylene 1.37
105
Case No.:34/45/82ALC4/2011
Party Name:PARAGON INDUSTRIES 31.07.2012 Status:Case Rejected HQ File :01/82/050/01211/AM12/ RLA File :08/24/040/00233/AM12/ Lic.No/Date:0810107536 09.01.2012 Defer Date: Decision : It was decided to close the case as the firm has not furnished information despite repeated reminders. 106
Case No.:36/1/82ALC4/2012
Party Name:MYLAN LABORATORIES LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01478/AM12/ RLA File :09/24/040/00489/AM12/ Lic.No/Date:0910050751 12.01.2012 Defer Date:30.08.2012 107
Case No.:52/1/82ALC4/2012
Party Name:HETERO LABS LIMITED 31.07.2012 Status:Case Approved HQ File :01/82/050/01494/AM12/ RLA File :09/24/040/00461/AM12/ Lic.No/Date:0910050752 12.01.2012 Defer Date: Decision : It was noticed that the case was earlier approved in meeting no. 12 dated 3.7.2012. Hence the case was withdrawn. 108
Case No.:18/1/82ALC4/2012
Party Name:RA CHEM PHARMA LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01460/AM12/ RLA File :09/24/040/00493/AM12/ Lic.No/Date:0910050772 13.01.2012 Defer Date:30.08.2012 109
Case No.:65/1/82ALC4/2012
Party Name:SUVEN LIFE SCIENCES LIMITED 31.07.2012 Status:Case Approved HQ File :01/82/050/01507/AM12/ RLA File :09/24/040/00483/AM12/ Lic.No/Date:0910050770 13.01.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/263/2012PI(Norms) dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg 5Bromo2Iodopyrimidine 1 kg 1. 1,1,3,3Tetra Methoxy Propane 1.43 2. Bromine Liquid 1.25 3. Phosphorous Oxy Chloride 1.27 4. Hydroiodic Acid 55% 1.34 \RA may take appropriate action as per the decision of Norms Committee
Case No :69/1/82ALC4/2012
Party Name:VIVIMED LABS LIMITED Meet No/Date:14/82ALC4/2012 Status:Case
110
Case No.:69/1/82ALC4/2012
Party Name:VIVIMED LABS LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01511/AM12/ RLA File :09/24/040/00496/AM12/ Lic.No/Date:0910050771 13.01.2012 Defer Date:30.08.2012 Decision : It was decided to call from the firm production and consumption data duly certified by the Central Excise Authority for the last three years. Accordingly, the case was deferred for 30.8.2012. 111
Case No.:21/1/82ALC4/2012
Party Name:AUROBINDO PHARMA LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01463/AM12/ RLA File :09/24/040/00447/AM12/ Lic.No/Date:0910050799 17.01.2012 Defer Date:30.08.2012 112
Case No.:66/1/82ALC4/2012
Party Name:SUVEN LIFE SCIENCES LIMITED 31.07.2012 Status:Case Approved HQ File :01/82/050/01508/AM12/ RLA File :09/24/040/00479/AM12/ Lic.No/Date:0910050800 17.01.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/263/2012PI(Norms) dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg 1Bromo2Iodobenzene 1 kg 1. 2Bromo Aniline 1.086 2. Potassium Iodide 0.733 3. Cyclohexane 2.75 113
Case No.:11/49/82ALC4/2011
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01320/AM12/ RLA File :04/24/040/00280/AM12/ Lic.No/Date:0410132899 18.01.2012 Defer Date:30.08.2012 Decision : : It was decided to defer the case for 30.8.2012 for comments of Department of Pharmaceuticals 114
Case No.:26/14/82ALC4/2012
Party Name:IPCA LABORATORIES LIMITED 31.07.2012 Status:Case Approved HQ File :01/82/050/00403/AM13/ RLA File :03/94/040/00900/AM12/ Lic.No/Date:0310677713 19.01.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 6/82 dated 8.5.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
Export Product Export Quantity S.No Import Product Quantity Allowed Artemether 20 mg & Lumefantrine 120 mg Tablets 1 million tablets 1. Artemisinin 30.6 kg 2. Boron Trifluoride Ethyl Etherate 1.428 kg 3. Sodium Borohydride 12.17 kg 4. Methanol 320.0 kg 5. Iso Propyl Alcohol 163.0 kg 6. 2,7 Dichloroflourene 104.444 kg 7. Parachloro Benzyldehyde 42.5707 kg 8. N,NDibutylamine 131.715 kg RA may take appropriate action as per the decision of NC. 115
Case No.:39/1/82ALC4/2012
Party Name:SUVEN LIFE SCIENCES LIMITED 31.07.2012 Status:Case Approved HQ File :01/82/050/01481/AM12/ RLA File :09/24/040/00505/AM12/ Lic.No/Date:0910050872 19.01.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/261/2012PI(Norms) dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg 5Chlorothiophene2carboxylic Acid (5CTA) 1 kg 1. 2Chlorothiophene 1.126 116
Case No.:45/1/82ALC4/2012
Party Name:SMILAX LABORATORIES LIMITED 31.07.2012 Status:Case Approved HQ File :01/82/050/01487/AM12/ RLA File :09/24/040/00474/AM 12// Lic.No/Date:0910050867 19.01.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/212/2012PI(Norms) dated 24.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg ®3(Tertbutyl dimethyl silyloxy) pentanedioic acid mono tert butyl ester (TB17) 1 kg 1. Anhydrous sodium sulphate 0.184 2. Lipozyme CALB L 0.0556 3. Dimethyl3hydroxy glutarate 1.106 4. Diterbutyl dicarbonate 1.564 5. Ethyl Acetate 3.18 6. Imidazole 1.319 7. Methanol 2.80 8. Dichloromethane 1.96
nHexane 3.12 10. NMethyl morpholine 0.579 11. Potassium carbonate 0.631 12. RPhenylethyl amine 0.480 13. Tertiary butanol 1.31 14. Toluene 9.88 15 Tertiary butyl dimethyl silyl chloride 2.136 16 N,NDimethylaminopyridine 0.0933 17. Dimethylamino1propylamine 0.222 117
Case No.:44/49/82ALC4/2011
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01353/AM12/ RLA File :03/94/040/00911/AM12/ Lic.No/Date:0310677527 19.01.2012 Defer Date:30.08.2012 118
Case No.:70/1/82ALC4/2012
Party Name:SUVEN LIFE SCIENCES LIMITED 31.07.2012 Status:Case Approved HQ File :01/82/050/01512/AM12/ RLA File :09/24/040/00504/AM12/ Lic.No/Date:0910050873 19.01.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/262/2012PI(Norms) dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg 1,2,3,5TetraOAcetylBD Ribofuranose 1 kg 1. Iso Propyl Alcohol 3.12 2. Toluene 0.35 3. DRibose 1.123 119
Case No.:25/49/82ALC4/2011
31.07.2012 Status:Case Approved HQ File :01/82/050/01334/AM12/ RLA File :03/94/040/00925/AM12/ Lic.No/Date:0310677829 20.01.2012 Defer Date: Decision : In the personal Hearing held on 7.2.2012, the firm was requested to submit the revised application On the basis of revised application submitted by the firm and in the light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/297/2011 PI(Norms) dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty Sl No Import items Qty allowed
Export product Export Qty. Sl.No. Import items Qty. allowed Kg/kg LNorephedrine HCL 1 kg 1. Benzaldehyde 4.165 2. Hydroxylamine Hcl/Hydroxylamine Sulphate 2.208 3. Caustic Soda Lye 12.104 4. Oxalic Acid 2.528 5. EDTA 0.155 6. Methanol 4.50 7. 1.60 8. Toluene 5.94 9. Activated Carbon 0.030 10. Acetone 0.80 120
Case No.:23/49/82ALC4/2011
Party Name:SALVI CHEMICAL INDUSTRIES LIMITED 31.07.2012 Status:Case Approved HQ File :01/82/050/01332/AM12/ RLA File :03/95/040/00884/AM12/ Lic.No/Date:0310678434 24.01.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/253/2012PI(Norms) dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Halquinol 60% 1 kg 1. 8Hydroxy Quinoline 0.462 RA may take appropriate action as per the decision of NC. 121
Case No.:2/1/82ALC4/2012
Party Name:RA CHEM PHARMA LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01444/AM12/ RLA File :09/24/040/00511/AM12/ Lic.No/Date:0910050974 25.01.2012 Defer Date:30.08.2012 Decision : : It was decided to defer the case for 30.8.2012 for comments of Department of Pharmaceuticals. 122
Case No.:79/49/82ALC4/2011
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 31.07.2012 Status:Case Deferred HQ File :01/82/050/01388/AM12/ RLA File :07/24/040/00425/AM12/ Lic.No/Date:0710085812 25.01.2012 Defer Date: 30.8.2012 123
Case No.:2/45/82ALC4/2011
Party Name:FDC LTD 31.07.2012 Status:Case Deferred HQ File :01/82/050/01179/AM12/ RLA File :03/94/040/00938/AM12/ Lic.No/Date:0310678976 27.01.2012 Defer Date:30.08.2012
Decision : : It was decided to defer the case for 30.8.2012 for comments of Department of Pharmaceuticals. 124
Case No.:39/49/82ALC4/2011
Party Name:AMI LIFESCIENCES P LTD 31.07.2012 Status:Case Deferred HQ File :01/82/050/01348/AM12/ RLA File :34/24/040/00226/AM12/ Lic.No/Date:3410033054 27.01.2012 Defer Date:30.08.2012 Decision : : It was decided to defer the case for 30.8.2012 for comments of Department of Pharmaceuticals. 125
Case No.:42/49/82ALC4/2011
Party Name:CADILA HEALTHCARE LTD., 31.07.2012 Status:Case Deferred HQ File :01/82/050/01351/AM12/ RLA File :08/24/040/00236/AM12/ Lic.No/Date:0810108169 27.01.2012 Defer Date:30.08.2012 Decision : : It was decided to defer the case for 30.8.2012 for comments of Department of Pharmaceuticals. 126
Case No.:56/49/82ALC4/2011
Party Name:IPCA LABORATORIES LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01365/AM12/ RLA File :03/94/040/00927/AM12/ Lic.No/Date:0310678993 27.01.2012 Defer Date:30.08.2012 Decision : : It was decided to defer the case for 30.8.2012 for comments of Department of Pharmaceuticals. 127
Case No.:32/46/82ALC4/2011
31.07.2012 Status:Case Approved HQ File :01/82/050/01248/AM12/ RLA File :03/94/040/00942/AM12/ Lic.No/Date:0310679417 31.01.2012 Defer Date: Decision : In the personal Hearing held on 7.2.2012, the firm was requested to submit the revised application. On the basis of revised application submitted by the firm and in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/294/2011 PI(Norms) dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Kg/kg PyrrolidinylLNorephedrine HCL 1 kg 1. Benzaldehyde 3.14 2. Caustic Soda Flakes 9.10 3. HAH/HAS 1.66 4. Catalyst P99 5. Oxalic Acid 1.94 6. Activated Carbon 0.035 7. Acetone 1.00 8. Caustic Pottash Flakes 2.165 9. Methanol 3.06 10. EDTA 0.116
11 Toluene 4.80 12 14 Dibromobutane 2.29 128
Case No.:47/46/82ALC4/2011
31.07.2012 Status:Case Approved HQ File :01/82/050/01263/AM12/ RLA File :03/94/040/00943/AM12/ Lic.No/Date:0310679893 02.02.2012 Defer Date: Decision : : In the personal Hearing held on 7.2.2012, the firm was requested to submit the revised application On the basis of revised application submitted by the firm and in the light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/297/2011 PI(Norms) dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Kg/kg LNorephedrine HCL 1 kg 1. Benzaldehyde 4.165 2. Hydroxylamine Hcl/Hydroxylamine Sulphate 2.208 3. Caustic Soda Lye 12.104 4. Oxalic Acid 2.528 5. EDTA 0.155 6. Methanol 4.50 7. 1.60 8. Toluene 5.94 9. Activated Carbon 0.030 10. Acetone 0.80 129
Case No.:26/1/82ALC4/2012
Party Name:METROCHEM API PVT. LTD. 31.07.2012 Status:Case Deferred HQ File :01/82/050/01468/AM12/ RLA File :09/24/040/00480/AM12/ Lic.No/Date:0910051119 06.02.2012 Defer Date:30.08.2012 130
Case No.:34/1/82ALC4/2012
Party Name:CADILA HEALTHCARE LTD., 31.07.2012 Status:Case Deferred HQ File :01/82/050/01476/AM12/ RLA File :08/24/040/00238/AM12/ Lic.No/Date:0810108441 06.02.2012 Defer Date:30.08.2012
Case No.:41/49/82ALC4/2011
Party Name:CADILA HEALTHCARE LTD., 31.07.2012 Status:Case Deferred
131 HQ File :01/82/050/01350/AM12/ RLA File :08/24/040/00244/AM12/ Lic.No/Date:0810108442 06.02.2012 Defer Date:30.08.2012 132
Case No.:12/49/82ALC4/2011
Party Name:AMI LIFESCIENCES P LTD 31.07.2012 Status:Case Deferred HQ File :01/82/050/01321/AM12/ RLA File :34/24/040/00237/AM12/ Lic.No/Date:3410033146 07.02.2012 Defer Date:30.08.2012 133
Case No.:29/1/82ALC4/2012
Party Name:HETERO DRUGS LIMITED, 31.07.2012 Status:Case Deferred HQ File :01/82/050/01471/AM12/ RLA File :09/24/040/00546/AM12/ Lic.No/Date:0910051150 07.02.2012 Defer Date:30.08.2012 134
Case No.:50/49/82ALC4/2011
Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:14/82ALC4/2012 31.07.2012 Status:Case Approved HQ File :01/82/050/01359/AM12/ RLA File :34/24/040/00239/AM12/ Lic.No/Date:3410033158 08.02.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 2/11 dated 13.4.2010, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Qty. Sl.No. Import items Qty. allowed Azithromycin Step‐4 1 KGA. 1. Erythromycin Thiocyanate 2.00 KGA 2. Hydroxylamine Hydrochloirde 0.91 kg 3. Methanol 2.72 kg 4. Methane Sulfonyl Chloride 0.72 kg 5. Acetone 6.45 kg 6. Ethyl Alcohol 2.81 liter 7. Methylene Chloride Not allowed 8. Acퟣ�vated Carbon 0.01 kg 9. Plaퟣ�num Catalyst with base Acퟣ�vated Carbon 0.001 kg
Case No.:51/46/82ALC4/2011
Party Name:RELIANCE INDUSTRIES LTD. 31.07.2012 Status:Case Deferred HQ File :01/82/050/01267/AM12/ RLA File :03/95/040/00867/AM12/ Lic.No/Date:0310680799 08.02.2012 Defer Date:30.08.2012
135 08.02.2012 Date:30.08.2012 Decision : It was noticed that Department of Chemicals and Petrochemicals vide their letter no. 46011/80/2012PC.II dated 25.6.2012 has requested the firm to furnish the following information: Basis/justification for the applied quanity of Naphtha for the export of Butene1. In the process flow chart the LPG Feed (C4 Raffinate) has been indicated as starting raw material whereas Naphtha has been applied for import. The reasons for the same may be furnished. Detailed manufacturing process along with justification for yields/wastages at each stage along with the value of byproducts/coproducts from Naphtha and LPG Feed (C 4 Raffinate) separately. Guaranteed norms of foreign collaborator, if any, for the consumption/requirement of raw material for the manufacture of Butene1. Complete material balance indicating input and output material at each stage of manufacturing process. Details of production of export product under reference and corresponding consumption of raw material in the year 200910, 201011 and 201112 duly certified by CA may be furnished. Any other relevant information. It was decided to remind the firm to furnish the above information within 15 days failing which the case would be closed. Accordingly, the case was deferred for 30.8.2012. 136
Case No.:40/1/82ALC4/2012
Party Name:MEDREICH LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01482/AM12/ RLA File :07/24/040/00455/AM12/ Lic.No/Date:0710086215 10.02.2012 Defer Date:30.08.2012 137
Case No.:63/1/82ALC4/2012
Party Name:IPCA LABORATORIES LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01505/AM12/ RLA File :03/94/040/00965/AM12/ Lic.No/Date:0310681706 13.02.2012 Defer Date:30.08.2012 138
Case No.:7/1/82ALC4/2012
Party Name:HETERO LABS LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01449/AM12/ RLA File :09/24/040/00562/AM12/ Lic.No/Date:0910051229 13.02.2012 Defer Date:30.08.2012 139
Case No.:12/1/82ALC4/2012
Party Name:ARCH PHARMALABS LTD 31.07.2012 Status:Case Deferred HQ File :01/82/050/01454/AM12/ RLA File :03/94/040/00984/AM12/ Lic.No/Date:0310681831 14 02 2012 Defer Date:30 08 2012
14.02.2012 Date:30.08.2012 140
Case No.:16/1/82ALC4/2012
Party Name:MYLAN LABORATORIES LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01458/AM12/ RLA File :09/24/040/00526/AM12/ Lic.No/Date:0910051248 14.02.2012 Defer Date:30.08.2012 141
Case No.:27/1/82ALC4/2012
31.07.2012 Status:Case Deferred HQ File :01/82/050/01469/AM12/ RLA File :03/94/040/00983/AM12/ Lic.No/Date:0310681784 14.02.2012 Defer Date:30.08.2012 142
Case No.:38/1/82ALC4/2012
31.07.2012 Status:Case Deferred HQ File :01/82/050/01480/AM12/ RLA File :03/94/040/00992/AM12/ Lic.No/Date:0310681860 14.02.2012 Defer Date:30.08.2012 143
Case No.:55/1/82ALC4/2012
31.07.2012 Status:Case Deferred HQ File :01/82/050/01497/AM12/ RLA File :03/94/040/00996/AM12/ Lic.No/Date:0310681891 14.02.2012 Defer Date:30.08.2012 144
Case No.:56/1/82ALC4/2012
31.07.2012 Status:Case Deferred HQ File :01/82/050/01498/AM12/ RLA File :03/94/040/00991/AM12/ Lic.No/Date:0310681844 14.02.2012 Defer Date:30.08.2012 145
Case No.:57/1/82ALC4/2012
31.07.2012 Status:Case Deferred HQ File :01/82/050/01499/AM12/ RLA File :03/94/040/00995/AM12/ Lic.No/Date:0310681873 14.02.2012 Defer Date:30.08.2012
146
Case No.:49/1/82ALC4/2012
Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:14/82ALC4/2012 31.07.2012 Status:Case Deferred HQ File :01/82/050/01491/AM12/ RLA File :03/94/040/00757/AM12/ Lic.No/Date:0310682083 15.02.2012 Defer Date:30.08.2012 Decision : It was decided to defer the case for 30.8.2012 for comments of Department of Chemicals and Petrochemicals. 147
Case No.:67/1/82ALC4/2012
Party Name:CHEMSPEC CHEMICALS PVT LTD 31.07.2012 Status:Case Deferred HQ File :01/82/050/01509/AM12/ RLA File :03/94/040/01007/AM12/ Lic.No/Date:0310682171 15.02.2012 Defer Date:30.08.2012 Decision : It was decided to defer the case for 30.8.2012 for comments of Department of Chemicals and Petrochemicals. 148
Case No.:35/1/82ALC4/2012
Party Name:SPECTRUM LIFE SCIENCES PRIVATE LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01477/AM12/ RLA File :04/24/040/00309/AM12/ Lic.No/Date:0410133868 16.02.2012 Defer Date:30.08.2012 149
Case No.:28/1/82ALC4/2012
31.07.2012 Status:Case Deferred HQ File :01/82/050/01470/AM12/ RLA File :03/94/040/01016/AM12/ Lic.No/Date:0310682483 17.02.2012 Defer Date:30.08.2012 150
Case No.:31/1/82ALC4/2012
31.07.2012 Status:Case Approved HQ File :01/82/050/01473/AM12/ RLA File :03/94/040/01011/AM12/ Lic.No/Date:0310682526 17.02.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/111/2012PI(Norms) dated 13.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Gemicitabine Hydrochloride 1 kg 1. 3,5 ODibenzoyl 2Deoxy2,2 Diflurocytidine 1.753 2. Methanol 1.31
Case No :64/1/82 ALC4/2012
Party Name:ARCH PHARMALABS LTD Meet No/Date:14/82 ALC4/2012 Status:Case
151
Case No.:64/1/82ALC4/2012
31.07.2012 Status:Case Approved HQ File :01/82/050/01506/AM12/ RLA File :03/94/040/01012/AM12/ Lic.No/Date:0310682484 17.02.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/111/2012PI(Norms) dated 13.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Gemicitabine Hydrochloride 1 kg 1. 3,5 ODibenzoyl 2Deoxy2,2 Diflurocytidine 1.753 2. Methanol 1.31 152
Case No.:51/1/82ALC4/2012
Party Name:INCHEM LABORATORIES PRIVATE LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01493/AM12/ RLA File :09/24/040/00579/AM12/ Lic.No/Date:0910051360 21.02.2012 Defer Date:23.08.2012 Decision : It was decided to defer the case for 23.8.2012 for comments of Department of Pharmaceuticals. 153
Case No.:3/49/82ALC4/2011
Party Name:KOPRAN LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01312/AM12/ RLA File :03/94/040/01022/AM 12/ Lic.No/Date:0310683054 22.02.2012 Defer Date:23.08.2012 154
Case No.:58/1/82ALC4/2012
Party Name:RA CHEM PHARMA LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01500/AM12/ RLA File :09/24/040/00564/AM12/ Lic.No/Date:0910051391 22.02.2012 Defer Date:23.08.2012 155
Case No.:5/2/82ALC4/2012
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 31.07.2012 Status:Case Deferred HQ File :01/82/050/01522/AM12/ RLA File :04/24/040/00314/AM12/ Lic.No/Date:0410134051 23.02.2012 Defer Date:23.08.2012
Case No.:7/49/82ALC4/2011
Party Name:EMCURE PHARMACEUTICALS LIMITED 31 07 2012 Status:Case Deferred
156 LIMITED 31.07.2012 Deferred HQ File :01/82/050/01316/AM12/ RLA File :31/83/040/00236/AM 12/ Lic.No/Date:3110053141 dated 24.02.2011 Defer Date:23.08.2012 Decision : It was decided to defer the case for 23.8.2012 for comments of Department of Pharmaceuticals 157
Case No.:60/49/82ALC4/2011
31.07.2012 Status:Case Deferred HQ File :01/82/050/01369/AM12/ RLA File :03/94/040/00125/AM 12 Lic.No/Date:0310683824 29.02.2012 Defer Date:23.08.2012 158
Case No.:63/49/82ALC4/2011
Party Name:s.r.s PHARMACEUTICALS LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01372/AM12/ RLA File :03/95/040/00967/AM 12// Lic.No/Date:0310683994 29.02.2012 Defer Date:23.08.2012 Decision : : It was decided to defer the case for 23.8.2012 for comments of Department of Pharmaceuticals 159
Case No.:10/1/82ALC4/2012
Party Name:ANUPAM RASAYAN (INDIA) LTD. 31.07.2012 Status:Case Deferred HQ File :01/82/050/01452/AM12/ RLA File :52/24/040/00052/AM 12/ Lic.No/Date:5210037972 01.03.2012 Defer Date:23.08.2012 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/97/2008Ch. II dated 28.9.2010, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed 2Chloro4(4Chloro Phenoxy) Acetophenone 1 kg 1. Para Chloro Phenol 0.967 kg 2. Meta Dichloro Benzene 1.350 kg 160
Case No.:61/1/82ALC4/2012
Party Name:RANBAXY LABORATORIES LTD 31.07.2012 Status:Case Deferred HQ File :01/82/050/01503/AM12/ RLA File :05/24/040/00429/AM12/ Lic.No/Date:0510319400 02.03.2012 Defer Date:23.08.2012
Case No.:77/1/82ALC4/2012
Party Name:UNIMARK REMEDIES LIMITED., 31.07.2012 Status:Case Deferred
161 HQ File :01/82/050/01519/AM12/ RLA File :03/95/040/00865/AM11/ Lic.No/Date:0310687522 22.03.2012 Defer Date:23.08.2012 162
Case No.:78/1/82ALC4/2012
Party Name:UNIMARK REMEDIES LIMITED., 31.07.2012 Status:Case Deferred HQ File :01/82/050/01520/AM12/ RLA File :03/95/040/00719/AM12/ Lic.No/Date:0310687530 22.03.2012 Defer Date:23.08.2012 163
Case No.:8/2/82ALC4/2012
Party Name:KOPRAN LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/01525/AM12/ RLA File :03/94/040/01020/AM12/ Lic.No/Date:0310688092 27.03.2012 Defer Date:23.08.2012 164
Case No.:1/2/82ALC4/2012
31.07.2012 Status:Case Deferred HQ File :01/82/050/00001/AM13/ RLA File :03/95/040/00970/AM12/ Lic.No/Date:0310688849 30.03.2012 Defer Date:23.08.2012 Decision : It was decided to defer the case for 23.8.2012 for comments of Department of Pharmaceuticals 165
Case No.:2/2/82ALC4/2012
31.07.2012 Status:Case Deferred HQ File :01/82/050/00002/AM13/ RLA File :03/95/040/01032/AM12/ Lic.No/Date:0310688856 30.03.2012 Defer Date:23.08.2012 166
Case No.:3/2/82ALC4/2012
31.07.2012 Status:Case Deferred HQ File :01/82/050/00003/AM13/ RLA File :03/95/040/01037/AM12/ Lic.No/Date:0310688874 30.03.2012 Defer Date:23.08.2012
Case No.:4/2/82ALC4/2012
Party Name:WOCKHARDT LIMITED 31.07.2012 Status:Case Approved HQ File :01/82/050/00004/AM13/ RLA File :03/95/040/01085/AM12/ Lic.No/Date:0310689242 02.04.2012 Defer Date: D i i I th li ht f li d i i t k i ti 24/82 d t d 13 9 2011 it d id d t tif d P 4 7 f HBP 1
167 Decision : In the light of earlier decision taken in meeting no. 24/82 dated 13.9.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Export Qty. Sl.No. Import item Qty. allowed Vitamin B12 (Cyanocobalamin) USP Micronised As per particle size A) Minimum 80% Less than 125 Microns B) Minimum 98% Less than 150 Microns 1 Kg. 1. Vitamin B12 (Cyanocobalamin) USP Micronised As per particle size Not more than 66% less than 125 Microns and Not more than 77% less than 150 Microns 1.01 kg 168
Case No.:19/9/82ALC4/2012
31.07.2012 Status:Case Deferred HQ File :01/82/050/00264/AM13/ RLA File :03/95/040/00963/AM12/ Lic.No/Date:0310690704 13.04.2012 Defer Date:23.08.2012 169
Case No.:2/5/82ALC4/2012
Party Name:TITAN LABORATORIES PVT. LTD. 31.07.2012 Status:Case Deferred HQ File :01/82/050/00174/AM13/ RLA File :03/95/040/00048/AM13/ Lic.No/Date:0310691572 20.04.2012 Defer Date:23.08.2012 170
Case No.:3/6/82ALC4/2012
Party Name:ROYAL PHARMA 31.07.2012 Status:Case Approved HQ File :01/82/050/00181/AM13/ RLA File :03/95/040/00056/AM13/ Lic.No/Date:0310692521 27.04.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/180/2012PI(Norms) dated 24.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Bicalutamide Sulfide Chemical Name: N[4Cyano3 (Trifluoro Methyl) Phenyl]3[(4 Flurophenyl thio)]2Hydroxy2 Methyl Propionalide 1 kg 1. N[4Cyano3(Trifluoro Methyl)phenyl] Methacrylamide 0.80 2. 4Flurothiopehnol 0.40
171
Case No.:6/6/82ALC4/2012
Party Name:BALAJI AMINES LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/00184/AM13/ RLA File :31/83/040/00262/AM12/ Lic.No/Date:3110053954 30.04.2012 Defer Date:23.08.2012 172
Case No.:2/14/82ALC4/2012
Party Name:ENCUBE ETHICALS PVT LTD 31.07.2012 Status:Case Deferred HQ File :01/82/050/00379/AM13/ RLA File :03/94/040/00006/AM13/ Lic.No/Date:0310693056 01.05.2012 Defer Date:23.08.2012 Decision : It was decided to defer the case for 23.8.2012 for comments of DC(MSME). 173
Case No.:3/14/82ALC4/2012
Party Name:ENCUBE ETHICALS PVT LTD 31.07.2012 Status:Case Deferred HQ File :01/82/050/00380/AM13/ RLA File :03/94/040/00053/AM13/ Lic.No/Date:0310692961 01.05.2012 Defer Date:23.08.2012 Decision : It was decided to defer the case for 23.8.2012 for comments of DC(MSME). 174
Case No.:13/14/82ALC4/2012
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/00390/AM13/ RLA File :03/94/040/00068/AM13/ Lic.No/Date:0310693154 02.05.2012 Defer Date:23.08.2012 Decision : It was decided to defer the case for 23.8.2012 for comments of Department of Chemicals and Petrochemicals. 175
Case No.:1/14/82ALC4/2012
Party Name:GLENMARK GENERICS LIMITED 31.07.2012 Status:Case Approved HQ File :01/82/050/00378/AM13/ RLA File :03/94/040/00057/AM13/ Lic.No/Date:0310693327 03.05.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 46/82 dated 14.2.2012, it was decided to ratify norms under Para 4.7 of HBP v1 on prorata basis, as per details given below or as applied by the firm, whichever is less: Export Product Exp. Qty. S.No Import Item Qty. allowed/kg Ciclopirox Gel 0.77%, 30 gm 110000Numbers Ciclopirox USP 25.96 kg Ciclopirox Gel 0.77%, 45 gm 55500 Numbers Ciclopirox USP 19.576 kg Ciclopirox Gel 0.77%, 100 gm 31200 Numbers Ciclopirox USP 24.492 kg RA k i i h d i i f N C i
176
Case No.:14/14/82ALC4/2012
Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/00391/AM13/ RLA File :03/94/040/00070/AM13/ Lic.No/Date:0310693809 08.05.2012 Defer Date:23.08.2012 177
Case No.:15/14/82ALC4/2012
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 31.07.2012 Status:Case Approved HQ File :01/82/050/00392/AM13/ RLA File :03/94/040/00082/AM13/ Lic.No/Date:0310693787 08.05.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/20/2012Ch. II dated 22.5.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Camphor USP 1 kg 1. Alpha Pinene 1.146 kg 178
Case No.:4/14/82ALC4/2012
Party Name:ARIHANTANAM LIFECARE PVT. LTD. 31.07.2012 Status:Case Approved HQ File :01/82/050/00381/AM13/ RLA File :52/24/040/00005/AM13/ Lic.No/Date:5210038410 10.05.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 25/82 dated 20.9.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Artemether 1 Kg 1. Artemisinin 1.50 kg 179
Case No.:6/9/82ALC4/2012
Party Name:DEEPAK NITRITE LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/00251/AM13/ RLA File :31/83/040/00018/AM13/ Lic.No/Date:3110054170 10.05.2012 Defer Date:23.08.2012 Decision : It was decided to defer the case for 23.8.2012 for comments of Department of Chemicals and Petrochemicals.
Case No.:7/9/82ALC4/2012
Party Name:RELIANCE INDUSTRIES LTD. 31.07.2012 Status:Case Approved Q il 01/82/0 0/002 2/A 13/ A il 03/9 /040/00013/A 13/ i / 031069410 f
180 HQ File :01/82/050/00252/AM13/ RLA File :03/95/040/00013/AM13/ Lic.No/Date:0310694105 10.05.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their OM No. 46011/36/2012PC II dated 23.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Methyl Tertiary Butyl Ether (MTBE) 1 MT 1. Naphtha 0.908 MT 2. Methanol 0.345 MT 181
Case No.:8/9/82ALC4/2012
Party Name:RELIANCE INDUSTRIES LTD. 31.07.2012 Status:Case Approved HQ File :01/82/050/00253/AM13/ RLA File :03/95/040/00067/AM13/ Lic.No/Date:0310694114 10.05.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their OM No. 46011/36/2012PC II dated 23.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Methyl Tertiary Butyl Ether (MTBE) 1 MT 1. Naphtha 0.908 MT 2. Methanol 0.345 MT 182
Case No.:16/14/82ALC4/2012
Party Name:ENALTEC LABS PVT.LTD. 31.07.2012 Status:Case Approved HQ File :01/82/050/00393/AM13/ RLA File :03/94/040/00092/AM13/ Lic.No/Date:0310694521 14.05.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 10/82 dated 5.6.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Rosuvastatin Calcium 1 kg. 1. (4RCis) 6(Acetyloxy) –Methyl)2,2 Dimethyl1,3Dioxane4Acetic Acid1,1 Dimethylethyl Ester 1.871 kg 2. 4(4Fluorophenyl)6Isopropyl2[(N MethylN Methylsulphonyl)Amino)] Pyrimidine 5YLMethanol 1.871 kg RA concerned may take further necessary action as per above decision of NC.
Case No.:21/14/82ALC4/2012
Party Name:FORACE POLYMERS (P) LTD. Status:Case
183 31.07.2012 Deferred HQ File :01/82/050/00398/AM13/ RLA File :05/23/040/00037/AM13/ Lic.No/Date:0510324671 14.05.2012 Defer Date:23.08.2012 Decision : In the light of written comments received from Department of Industrial Policy and Promotion received vide their note dated 30.7.2012, it was decided to call from the firm the following details: Manufacturing process indicating stage wise wastage of all the raw materials. Consumption of all the raw materials (both imported and indigenous) with corresponding production of export items duly certified by concerned Central Excise/Chartered Accountant for three years. Accordingly, the case was deferred for 23.8.2012. 184
Case No.:10/9/82ALC4/2012
31.07.2012 Status:Case Deferred HQ File :01/82/050/00255/AM13/ RLA File :03/95/040/00094/AM13/ Lic.No/Date:0310694706 15.05.2012 Defer Date:23.08.2012 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/68/2012PI (Norms), it was decided to call from the firm the following technical details: Copy of Drug Manufacturing License alongwith list of approved items and approved composition of export product. Copy of Master Batch formula duly certified by Quality Control Incharge. Accordingly, the case was deferred for 23.8.2012 185
Case No.:11/14/82ALC4/2012
31.07.2012 Status:Case Approved HQ File :01/82/050/00388/AM13/ RLA File :03/94/040/00108/AM13/ Lic.No/Date:0310694765 15.05.2012 Defer Date: Decision : In the personal Hearing held on 7.2.2012, the firm was requested to submit the revised application On the basis of revised application submitted by the firm and in the light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/297/2011 PI(Norms) dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Kg/kg LNorephedrine HCL 1 kg 1. Benzaldehyde 4.165 2. Hydroxylamine Hcl/Hydroxylamine Sulphate 2.208 3. Caustic Soda Lye 12.104 4. Oxalic Acid 2.528
EDTA 0.155 6. Methanol 4.50 7. 1.60 8. Toluene 5.94 9. Activated Carbon 0.030 10. Acetone 0.80 186
Case No.:11/9/82ALC4/2012
31.07.2012 Status:Case Deferred HQ File :01/82/050/00256/AM13/ RLA File :03/95/040/00093/AM13/ Lic.No/Date:0310694735 15.05.2012 Defer Date:23.08.2012 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/68/2012PI (Norms), it was decided to call from the firm the following technical details: Copy of Drug Manufacturing License alongwith list of approved items and approved composition of export product. Copy of Master Batch formula duly certified by Quality Control Incharge. Accordingly, the case was deferred for 23.8.2012 187
Case No.:12/14/82ALC4/2012
Party Name:CIPLA LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/00389/AM13/ RLA File :03/94/040/00103/AM13/ Lic.No/Date:0310694809 16.05.2012 Defer Date:23.08.2012 188
Case No.:12/9/82ALC4/2012
Party Name:KEDIA ORGANIC CHEMICALS PVT.LTD. 31.07.2012 Status:Case Deferred HQ File :01/82/050/00257/AM13/ RLA File :03/94/040/00085/AM13/ Lic.No/Date:0310694811 16.05.2012 Defer Date:23.08.2012 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/105/2010Ch. II dated 7.2.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Mixture of Methyl Esters derived from Acid Oil (RE 100) 1 litre 1. Acid Oil 0.970 kg
189
Case No.:15/9/82ALC4/2012
31.07.2012 Status:Case Deferred HQ File :01/82/050/00260/AM13/ RLA File :03/95/040/00089/AM13/ Lic.No/Date:0310694925 16.05.2012 Defer Date:23.08.2012 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/68/2012PI (Norms), it was decided to call from the firm the following technical details: Copy of Drug Manufacturing License alongwith list of approved items and approved composition of export product. Copy of Master Batch formula duly certified by Quality Control Incharge. Accordingly, the case was deferred for 23.8.2012 190
Case No.:16/9/82ALC4/2012
31.07.2012 Status:Case Deferred HQ File :01/82/050/00261/AM13/ RLA File :03/95/040/00090/AM13/ Lic.No/Date:0310694936 16.05.2012 Defer Date:23.08.2012 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/68/2012PI (Norms), it was decided to call from the firm the following technical details: Copy of Drug Manufacturing License alongwith list of approved items and approved composition of export product. Copy of Master Batch formula duly certified by Quality Control Incharge. Accordingly, the case was deferred for 23.8.2012 191
Case No.:48/14/82ALC4/2012
Party Name:GEM AROMATICS PVT.LTD. 31.07.2012 Status:Case Deferred HQ File :01/82/050/00425/AM13/ RLA File :03/94/040/00091/AM13/ Lic.No/Date:0310694978 16.05.2012 Defer Date:23.08.2012 Decision : It was decided to defer the case for 23.8.2012 for comments of Department of Chemicals and Petrochemicals. 192
Case No.:35/14/82ALC4/2012
Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 31.07.2012 Status:Case Deferred HQ File :01/82/050/00412/AM13/ RLA File :03/94/040/00801/AM12/ Lic.No/Date:0310695056 17.05.2012 Defer Date:23.08.2012
Case No.:29/14/82ALC4/2012
Status:Case
193 y 31.07.2012 Deferred HQ File :01/82/050/00406/AM13/ RLA File :03/94/040/00705/AM12/ Lic.No/Date:0310695318 18.05.2012 Defer Date:23.08.2012 194
Case No.:30/14/82ALC4/2012
31.07.2012 Status:Case Deferred HQ File :01/82/050/00407/AM13/ RLA File :03/94/040/00706/AM12/ Lic.No/Date:0310695305 18.05.2012 Defer Date:23.08.2012 195
Case No.:31/14/82ALC4/2012
31.07.2012 Status:Case Deferred HQ File :01/82/050/00408/AM13/ RLA File :03/94/040/00807/AM12/ Lic.No/Date:0310695310 18.05.2012 Defer Date:23.08.2012 196
Case No.:32/14/82ALC4/2012
31.07.2012 Status:Case Deferred HQ File :01/82/050/00409/AM13/ RLA File :03/94/040/00802/AM12/ Lic.No/Date:0310695307 18.05.2012 Defer Date:23.08.2012 197
Case No.:33/14/82ALC4/2012
31.07.2012 Status:Case Deferred HQ File :01/82/050/00410/AM13/ RLA File :03/94/040/00815/AM12/ Lic.No/Date:0310695316 18.05.2012 Defer Date:23.08.2012 198
Case No.:5/14/82ALC4/2012
Party Name:NEW ALLIANCE DYECHEM PVT. LTD., 31.07.2012 Status:Case Deferred HQ File :01/82/050/00382/AM13/ RLA File :03/95/040/00105/AM13/ Lic.No/Date:0310695332 18.05.2012 Defer Date:23.08.2012 Decision : It was decided to defer the case for 23.8.2012 for comments of Department of Chemicals and Petrochemicals 199
Case No.:18/9/82ALC4/2012
Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. 31.07.2012 Status:Case Deferred HQ File :01/82/050/00263/AM13/ RLA File :03/94/040/00111/AM13/ Lic.No/Date:0310695465 21 05 2012 Defer Date:23 08 2012
21.05.2012 Date:23.08.2012 200
Case No.:27/14/82ALC4/2012
31.07.2012 Status:Case Deferred HQ File :01/82/050/00404/AM13/ RLA File :03/94/040/00804/AM12/ Lic.No/Date:0310695480 21.05.2012 Defer Date:23.08.2012 201
Case No.:28/14/82ALC4/2012
31.07.2012 Status:Case Deferred HQ File :01/82/050/00405/AM13/ RLA File :03/94/040/00805/AM12/ Lic.No/Date:0310695474 21.05.2012 Defer Date:23.08.2012 202
Case No.:36/14/82ALC4/2012
31.07.2012 Status:Case Deferred HQ File :01/82/050/00413/AM13/ RLA File :03/94/040/00811/AM12/ Lic.No/Date:0310695482 21.05.2012 Defer Date:23.08.2012 203
Case No.:21/9/82ALC4/2012
Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:14/82ALC4/2012 31.07.2012 Status:Case Deferred HQ File :01/82/050/00266/AM13/ RLA File :31/83/040/00026/AM13/ Lic.No/Date:3110054379 22.05.2012 Defer Date:23.08.2012 Decision : It was decided to defer the case for 23.8.2012 for comments of Department of Pharmaceuticals. 204
Case No.:54/14/82ALC4/2012
Party Name:AVA CHEMICALS PVT.LTD., 31.07.2012 Status:Case Deferred HQ File :01/82/050/00431/AM13/ RLA File :03/94/040/00066/AM13/ Lic.No/Date:0310695643 22.05.2012 Defer Date:23.08.2012 Decision : It was decided to defer the case for 23.8.2012 for comments of Department of Chemicals and Petrochemicals
Case No.:6/14/82ALC4/2012
Party Name:SHALINA LABORATORIES PVT. LTD. 31.07.2012 Status:Case Approved HQ File :01/82/050/00383/AM13/ RLA File :03/95/040/00077/AM13/ Lic.No/Date:0310695641 22.05.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 19/82 dated 9.8.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as
205 Export product Export Qty. Sl.No. Import item Qty. allowed Betasol Lotion 30 ml (Clobetasol Propionate Topical Solution 0.05% (w/v) 1 No. 1. Clobetasol Propionate 15.15 mg/30 ml bottle 2. Propylene Glycol BP 18.00 gm/30 ml bottle 3. Purell [packing material] As per packing policy. 206
Case No.:7/14/82ALC4/2012
Party Name:TITAN LABORATORIES PVT. LTD. 31.07.2012 Status:Case Approved HQ File :01/82/050/00384/AM13/ RLA File :03/95/040/00139/AM13/ Lic.No/Date:0310695840 23.05.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 1/82 dated 3.4.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Orlistat Pellets 50% 1 kg Orlistat 0.505/kg RA may take appropriate action as per the decision of Norms committee. 207
Case No.:8/14/82ALC4/2012
Party Name:MICRO INKS LTD. 31.07.2012 Status:Case Deferred HQ File :01/82/050/00385/AM13/ RLA File :03/95/040/00136/AM13/ Lic.No/Date:0310695836 23.05.2012 Defer Date:23.08.2012 Decision : It was decided to defer the case for 23.8.2012 for comments of Department of Chemicals and Petrochemicals. 208
Case No.:55/14/82ALC4/2012
Party Name:ANUH PHARMA LTD. 31.07.2012 Status:Case Deferred HQ File :01/82/050/00432/AM13/ RLA File :03/94/040/00094/AM13/ Lic.No/Date:0310696080 24.05.2012 Defer Date:23.08.2012 209
Case No.:10/14/82ALC4/2012
Party Name:UNITED BIOTECH PVT.LTD. 31.07.2012 Status:Case Deferred HQ File :01/82/050/00387/AM13/ RLA File :05/24/040/00062/AM13/ Lic.No/Date:0510325995 25.05.2012 Defer Date:23.08.2012 D i i I d id d d f h f 23 8 2012 f f D f Ph i l
210
Case No.:38/14/82ALC4/2012
31.07.2012 Status:Case Deferred HQ File :01/82/050/00415/AM13/ RLA File :03/94/040/00026/AM13/ Lic.No/Date:0310696238 25.05.2012 Defer Date:23.08.2012 211
Case No.:37/14/82ALC4/2012
Party Name:IPCA LABORATORIES LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/00414/AM13/ RLA File :03/94/040/00143/AM13/ Lic.No/Date:0310696330 28.05.2012 Defer Date:23.08.2012 212
Case No.:9/14/82ALC4/2012
Party Name:RANBAXY LABORATORIES LTD 31.07.2012 Status:Case Deferred HQ File :01/82/050/00386/AM13/ RLA File :05/24/040/00063/AM13/ Lic.No/Date:0510326034 28.05.2012 Defer Date:23.08.2012 213
Case No.:44/14/82ALC4/2012
Party Name:MELOG SPECIALITY CHEMICALS PVT. LTD. 31.07.2012 Status:Case Deferred HQ File :01/82/050/00421/AM13/ RLA File :03/95/040/00091/AM13/ Lic.No/Date:0310696608 29.05.2012 Defer Date:23.08.2012 214
Case No.:24/14/82ALC4/2012
Party Name:ANUPAM RASAYAN (INDIA) LTD 31.07.2012 Status:Case Deferred HQ File :01/82/050/00401/AM13/ RLA File :52/24/040/00008/AM13/ Lic.No/Date:5210038504 30.05.2012 Defer Date:23.08.2012 215
Case No.:51/14/82ALC4/2012
Party Name:AGIO PHARMACEUTICALS LTD 31.07.2012 Status:Case Deferred HQ File :01/82/050/00428/AM13/ RLA File :03/94/040/01186/AM12/ Lic.No/Date:0310696799 30.05.2012 Defer Date:23.08.2012
Case No :52/14/82 ALC4/2012
Part Name:CIPLA LIMITED Meet No/Date:14/82 ALC4/2012 Status:Case
216
Case No.:52/14/82ALC4/2012
Party Name:CIPLA LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/00429/AM13/ RLA File :03/94/040/00157/AM13/ Lic.No/Date:0310696798 30.05.2012 Defer Date:23.08.2012 217
Case No.:17/14/82ALC4/2012
Party Name:ACTAVIS PHARMA MANUFACTURING PVT.LTD 31.07.2012 Status:Case Approved HQ File :01/82/050/00394/AM13/ RLA File :04/24/040/00036/AM13/ Lic.No/Date:0410137015 05.06.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 30/82 dated 25.10.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Gabapentin Capsules 300 mg 1 No. 1. Gabapentin USP 300 mg 2. Corn Starch NF (Unipure F) 30 mg 3. Mannitol USP 39 mg 4. Talc USP 30 mg 5. Capsule # 1 Empty Gelatin As per packing policy RA may take appropriate action as per the decision of NC. 218
Case No.:42/14/82ALC4/2012
Party Name:MERCK LIMITED 31.07.2012 Status:Case Approved HQ File :01/82/050/00419/AM13/ RLA File :03/95/040/01116/AM12/ Lic.No/Date:0310697685 06.06.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 36/82 dated 6.12.2011, it was decided to ratify norms under Para 4.7of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Thiamine Disulfide 1 Kg. 1. Thiamine Hcl IP/BP/USP (Vit.B1 Hcl) 1.4199 kg 2. Sodium Hydroxide Pellets 0.4634 kg 3. Potassium hexacyanoferate III GR 0.0022 kg 4. Hydrochloric Acid Fuming 37% 0.3356 kg 5. Hydrogen Peroxide Solution 35% extra pure 0.2157 kg 6. Acetone 0.8702 Ltr. RA may take appropriate action as per the decision of Norms Committee. 219
Case No.:46/14/82ALC4/2012
Party Name:ENCUBE ETHICALS PVT LTD 31.07.2012 Status:Case Deferred HQ File :01/82/050/00423/AM13/ RLA File :03/94/040/00188/AM13/ Lic.No/Date:0310697620 06.06.2012 Defer Date:23.08.2012 Decision : It was decided to defer the case for 23.8.2012 for comments of Department of Pharmaceuticals.
220
Case No.:19/14/82ALC4/2012
Party Name:NEULAND LABORATORIES LTD 31.07.2012 Status:Case Deferred HQ File :01/82/050/00396/AM13/ RLA File :09/24/040/00101/AM13/ Lic.No/Date:0910052939 08.06.2012 Defer Date:23.08.2012 221
Case No.:53/14/82ALC4/2012
Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/00430/AM13/ RLA File :03/94/040/00888/AM12/ Lic.No/Date:0310697981 08.06.2012 Defer Date:23.08.2012 222
Case No.:1/12/82ALC4/2012
Party Name:TRADEWELL CORPORATION. 31.07.2012 Status:Case Approved HQ File :01/82/050/00331/AM13/ RLA File :03/95/040/00164/AM13/ Lic.No/Date:0310698125 11.06.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/270/2012PI(Norms) dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Cholic Acid 1 kg 1. Ox Bile Solids 2.93 kg 223
Case No.:18/14/82ALC4/2012
Party Name:ASTRIX LABORATORIES LTD., 31.07.2012 Status:Case Deferred HQ File :01/82/050/00395/AM13/ RLA File :09/24/040/00088/AM13/ Lic.No/Date:0910052978 12.06.2012 Defer Date:23.08.2012 Decision : It was decided to defer the case for 23.8.2012 for comments of Department of Pharmaceuticals. 224
Case No.:47/14/82ALC4/2012
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 31.07.2012 Status:Case Approved HQ File :01/82/050/00424/AM13/ RLA File :03/94/040/00203/AM13/ Lic.No/Date:0310698228 12.06.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/20/2012Ch. II dated 5.6.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed
Astrolide (DEP/IPM/BB) Astrolidein Diethyl Phthalate/Isopropyl Myristate/Benzyl Benzoate. Astrolide content 62.5% min) 1 kg 1. Isoamylene 0.380 kg 2. Propylene Oxide 0.280 kg 3. Alpha Methyl Styrene 0.500 kg 4. Paraformaldehyde 0.088 kg 225
Case No.:49/14/82ALC4/2012
Party Name:GEM AROMATICS PVT.LTD. 31.07.2012 Status:Case Deferred HQ File :01/82/050/00426/AM13/ RLA File :03/94/040/00207/AM13/ Lic.No/Date:0310698463 13.06.2012 Defer Date:23.08.2012 Decision : It was decided to defer the case for 23.8.2012 for comments of Department of Chemicals and Petrochemicals 226
Case No.:2/12/82ALC4/2012
Party Name:MELZER CHEMICALS PVT. LTD 31.07.2012 Status:Case Deferred HQ File :01/82/050/00332/AM13/ RLA File :31/83/040/00050/AM13/ Lic.No/Date:3110054679 14.06.2012 Defer Date:23.08.2012 Decision : It was decided to defer the case for 23.8.2012 for comments of Department of Chemicals and Petrochemicals. 227
Case No.:34/14/82ALC4/2012
Party Name:ENALTEC LABS PVT.LTD. 31.07.2012 Status:Case Approved HQ File :01/82/050/00411/AM13/ RLA File :03/94/040/00191/AM13/ Lic.No/Date:0310698661 14.06.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 10/82 dated 5.6.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Rosuvastatin Calcium 1 kg. 1. (4RCis) 6(Acetyloxy) –Methyl)2,2 Dimethyl1,3Dioxane4Acetic Acid1,1 Dimethylethyl Ester 1.871 kg 2. 4(4Fluorophenyl)6Isopropyl2[(N MethylN Methylsulphonyl)Amino)] Pyrimidine 5YLMethanol 1.871 kg RA concerned may take further necessary action as per above decision of NC. 228
Case No.:50/14/82ALC4/2012
Party Name:AARTI INDUSTRIES LIMITED 31.07.2012 Status:Case Deferred HQ Fil 01/82/050/00427/AM13/ RLA Fil 03/94/040/00187/AM13/ Li N /D t 0310698861 D f
228 HQ File :01/82/050/00427/AM13/ RLA File :03/94/040/00187/AM13/ Lic.No/Date:0310698861 15.06.2012 Defer Date:23.08.2012 Decision : It was decided to defer the case for 23.8.2012 for comments of Department of Chemicals and Petrochemicals. 229
Case No.:3/12/82ALC4/2012
Party Name:BILCARE LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/00333/AM13/ RLA File :31/83/040/00057/AM13/ Lic.No/Date:3110054717 18.06.2012 Defer Date:23.08.2012 230
Case No.:45/14/82ALC4/2012
Party Name:MANGALAM DRUGS & ORGANICS LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/00422/AM13/ RLA File :03/95/040/00081/AM13/ Lic.No/Date:0310699034 18.06.2012 Defer Date:23.08.2012 231
Case No.:39/14/82ALC4/2012
Party Name:CIPLA LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/00416/AM13/ RLA File :03/94/040/00225/AM13/ Lic.No/Date:0310699167 19.06.2012 Defer Date:23.08.2012 232
Case No.:43/14/82ALC4/2012
Party Name:ROYAL PHARMA 31.07.2012 Status:Case Approved HQ File :01/82/050/00420/AM13/ RLA File :03/95/040/00194/AM13/ Lic.No/Date:0310699174 19.06.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/180/2012PI(Norms) dated 24.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Bicalutamide Sulfide Chemical Name: N[4Cyano3 (Trifluoro Methyl) Phenyl]3[(4 Flurophenyl thio)]2Hydroxy2 Methyl Propionalide 1 kg 1. N[4Cyano3(Trifluoro Methyl)phenyl] Methacrylamide 0.80 2. 4Flurothiopehnol 0.40
Case No.:40/14/82ALC4/2012
Party Name:CIPLA LIMITED 31.07.2012 Status:Case Deferred
233 HQ File :01/82/050/00417/AM13/ RLA File :03/94/040/00224/AM13/ Lic.No/Date:0310699235 20.06.2012 Defer Date:23.08.2012 Decision : It was decided to defer the case for 23.8.2012 for comments of Department of Pharmaceuticals. 234
Case No.:41/14/82ALC4/2012
Party Name:METROPOLITAN EXIMCHEM LTD. 31.07.2012 Status:Case Approved HQ File :01/82/050/00418/AM13/ RLA File :03/95/040/00189/AM13/ Lic.No/Date:0310699267 20.06.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/75/2008Ch. II dated 9.5.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed NEthyl Carbazole 1 kg 1. Carbazole 1.13 kg 235
Case No.:22/14/82ALC4/2012
Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:14/82ALC4/2012 31.07.2012 Status:Case Deferred HQ File :01/82/050/00399/AM13/ RLA File :31/83/040/00070/AM13/ Lic.No/Date:3110054967 13.07.2012 Defer Date:23.08.2012 Decision : It was decided to defer the case for 23.8.2012 for comments of Department of Pharmaceuticals. 236
Case No.:23/14/82ALC4/2012
Party Name:BALAJI AMINES LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/00400/AM13/ RLA File :31/83/040/00061/AM13/ Lic.No/Date:3110054974 13.07.2012 Defer Date:23.08.2012 Decision : : It was decided to defer the case for 23.8.2012 for comments of Department of Chemicals and Petrochemicals. 237
Case No.:57/14/82ALC4/2012
Party Name:BALAJI AMINES LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/00434/AM13/ RLA File :31/83/040/00075/AM13/ Lic.No/Date:3110055038 19.07.2012 Defer Date:23.08.2012 238
Case No.:58/14/82ALC4/2012
Party Name:BALAJI AMINES LIMITED 31.07.2012 Status:Case Deferred HQ File :01/82/050/00435/AM13/ RLA File :31/83/040/00073/AM13/ Lic.No/Date:3110055046 19.07.2012 Defer Date:23.08.2012
Date:01.08.2012 Place:New Delhi Lalita Maini Foreign Trade Development Officer Export product Export Qty. Sl.No. Import items Qty. allowed (kg/kg) DLNaproxen 1 kg 1. BNaphthol 1.14 2. Methanol 1.29 3. Sulfuric Acid As per Central Excise Certificate 4. Ethylene Chloride 0.78 5. C S Lye 2.51 6. Nitro Methane 2.51 7. Acetyl Chloride 0.35 8. Aluminium Chloride 1.37 9. Sodium Carbonate As per Central Excise Certificate 10. Sodium Hydro Sulfite 11. Monochloro Acetic Acid 0.89 12. 2Butanol 0.95 13 Toluene 0.38 14 ptoluene sulfonic acid As per central i tifi t
excise certificate 15 KOH Flakes 1.14 16. Acetic Acid 0.70 17. Hydroxylamine Sulfate Or Hydroxylamine HCL 0.55 Or 0.47 18 to 22
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