DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi 0
Para 4.7 Decision(DRAFT)
MEETING NUMBER : 23/82ALC4/2013 MEETING DATE : 06.03.2014 but actually held on 13.03.2014 The Meeting No. 23/82 of 201314 to consider the cases/issues under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to products and falling under Chapter 29 and 30 was held on 06.03.2014 but actually held on 13.03.2014 under the Chairmanship of, Shri Jaikant Singh, Addl DGFT in Room No.11, Udyog Bhawan, New Delhi. Following members were present: 1. Shri D.N. Mathur. Consultantr, Department of Pharmaceutical 2. Shri Jasbir Singh, Consultantr, Department of C&PC 3. Shri R.C. Meena, Deputy Director General of Foreign Trade 4. Dr. Nitin Jain D/o Biotechnology 1. Since no communication /comments were received from any of the Administrative Departments. The minutes of the meeting held on 20.02.2014 was treated as approved. 2. The following cases/issues were discussed and the committee took the decision as mentioned against the case:
Case No. B‐271
M/s Aurobindo Pharma Ltd., Mee韣�ng No. 23/AM14 dated – 06.03.2014 F.No.01/82/162/00005/AM14/DESIII Licence No. 0910024757 dated 30.11.2005 RA File No. 09/24/040/331/AM06 Decision: Committee considered the case and it was decided to refer the case to PRC Section with the details received from RA Hyderabad.
Case No. B‐272
M/s Gitanjali Chemicals Pvt Ltd. Mee韣�ng No. 23/AM14 dated – 06.03.2014 F.No.01/82/050/01188/AM13/DESIII Licence No. 0310716657 dated 07.12.2012 RA File No. 03/94/040/747/AM13 Decision: In the light of wri埜�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/105/2011‐Ch II dated 13.03.2014, it was decided to ra韣�fy
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 item Qty. allowed Anisole Pure (Min.99%) 1 Kg. 1. Anisole Crude (Max. 96%) 1. 05 kg 2. Caustic Soda Flakes 0.120 kg RA concerned may take further necessary action as per above decision of NC.
Case No. B 273
M/s. Shiva Pharma Ltd. Mee韣�ng No. 23/AM14 dated – 06.03.2014 F. No. 01/82/162/00016AM13/DES‐III Adv. Lic. No 3410025487 dated 30.10.09 Adv. Lic. No 3410025693 dated 25.11.09 Adv. Lic. No 3410026511 dated 03.03.10 Adv. Lic. No 3410027522 dated 16.07.10 Decision: It was decided to defer the case for 10.04.2014 for comments of Department of C&PC. 1
Case No.:1/21/82ALC4/2010
Party Name:OGENE SYSTEMS INDIA PVT. LTD. Meet No/Date:23/82ALC4/2013 06.03.2014 Status:Case Deferred HQ File :01/82/050/00639/AM11/ RLA File :09/24/040/00182/AM11/ Lic.No/Date:0910043061 12.08.2010 Defer Date:10.04.2014 Decision :It was decided to defer the case 10.04.2014 for comments of Department of Chemicals and Petrochemicals 2
Case No.:28/28/82ALC4/2012
Party Name:MYLAN LABORATORIES LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00995/AM13/ RLA File :09/24/040/00270/AM13/ Lic.No/Date:0910053660 04.09.2012 Defer Date:10.04.2014 Decision :it was decided to remind the firm the following technical details: • Stepwise complete chemistry, mol. Wt of each input/output items and there Molar requirement alongwith technical justification. • % yield on molar basis for each step. • Quantity and Recovery of Solvents at each stage. • Past Production visàvis Actual consumption of all the inputs duly certified by Central Excise Authorities. The case was deferred for 10.04.2014
3
Case No.:120/23/82ALC4/2013
Party Name:ALKALOIDS CORPORATION 06.03.2014 Status:Case Approved HQ File :01/82/050/01167/AM14/ RLA File :02/24/040/00097/AM13/ Lic.No/Date:0210182063 13.09.2012 Defer Date: Decision : In t In the light of earlier decision taken in mee韣�ng no. 11/82 dated 05.09.2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v1 as per details given below or as applied bythe firm, whichever is less: Export product Export Quantity Sl.No. Import items Qty. allowed Noscapine BP/Noscapine Hcl BP 0.049 kg 1 1 X Papaverine (Wet)Crude containing Noscapine not more than 8% and crude Papaverine not more than 25% (on dry basis) Moisture content NLT 32% w/w 1kg Papaverine Hcl BP 0.153 kg RA may take appropriate ac韣�on as per the decision of Norms Commi埜�ee. 4
Case No.:9/31/82ALC4/2012
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/01049/AM13/ RLA File :04/24/040/00182/AM13/ Lic.No/Date:0410141372 29.11.2012 Defer Date:10.04.2014 Decision :It was decided to defer the case for 10.04.2014 for comments of Department of Pharmaceuticals. 5
Case No.:188/33/82ALC4/2012
Party Name:JUBILANT LIFE SCIENCES LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/01335/AM13/ RLA File :05/23/040/00345/AM13/ Lic.No/Date:0510340432 07.12.2012 Defer Date:10.04.2014 Decision: Reply received and sent to D/o Pharmaceuticals on 20.11.2013 for their comment. The case was deferred for 10.04.2014. 6
Case No.:96/33/82ALC4/2012
Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 06.03.2014 Status:Case Rejected HQ File :01/82/050/01243/AM13/ RLA File :07/24/040/00419/AM13/ Lic.No/Date:0710092979 08.01.2013 Defer Date: Decision: It was decided to reject the case as the firm has not furnished information despite repeated reminders.
7
Case No.:4/29/82ALC4/2012
Party Name:GLAND PHARMA LIMITED 06.03.2014 HQ File :01/82/050/01036/AM13/ RLA File :09/24/040/00497/AM13/ Lic.No/Date:0910054771 11.01.2013 Defer Date: Decision: It was decided to reject the case as the firm has not furnished information despite repeated reminders. 8
Case No.:2/30/82ALC4/2012
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 06.03.2014 Status:Case Deferred HQ File :01/82/050/01038/AM13/ RLA File :05/24/040/00389/AM13/ Lic.No/Date:0510343975 23.01.2013 Defer Date:10.04.2014 Decision: Request the firm to furnish the copy of application alonwith technical details as per appendix 33. The case was deferred for 10.04.2014. 9
Case No.:28/4/82ALC4/2013
06.03.2014 HQ File :01/82/050/00069/AM14/ RLA File :09/24/040/00520/AM13/ Lic.No/Date:0910054940 05.02.2013 Defer Date: Decision: It was decided to reject the case as the firm has not furnished information despite repeated reminders. 10
Case No.:37/1/82ALC4/2013
Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 06.03.2014 HQ File :01/82/050/01395/AM13/ RLA File :07/24/040/00487/AM13/ Lic.No/Date:0710093719 15.02.2013 Defer Date: Decision: It was decided to reject the case as the firm has not furnished information despite repeated reminders. 11
Case No.:131/23/82ALC4/2013
Party Name:SHIRDI CHEMICALS PVT. LTD. 06.03.2014 Status:Case Approved HQ File :01/82/050/01178/AM14/ RLA File :03/95/040/00900/AM13/ Lic.No/Date:0310724936 20.02.2013 Defer Date: Decision :In the light of wri埜�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/105/2011‐Ch II dated 13.03.2014, it was decided to ra韣�fy 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 CAME crude (Methyl2amino3 chlorobenzoate) OR 2Amino3 chlorobenzoic acid methyl ester, 1 kg 1. 23dichlorobenzoic acid 1.318 kg
crude CAS 77820587 A may take appropriate ac韣�on as per the decision of Norms Commi埜�ee. 12
Case No.:117/23/82ALC4/2013
Party Name:ALKALOIDS CORPORATION 06.03.2014 Status:Case Approved HQ File :01/82/050/01164/AM14/ RLA File :02/24/040/00194/AM13/ Lic.No/Date:0210187805 20.03.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/340/2012PI(Norms) dated 26.09.2013, 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 Exp. Qty. Sl.No. Import items Qty. allowed Noscapine BP/Noscapine Hcl BP 1 kg 1. Noscapine crude 95% 1.185 kg 13
Case No.:33/2/82ALC4/2013
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 06.03.2014 Status:Case Deferred HQ File :01/82/050/01480/AM13/ RLA File :05/24/040/00481/AM13/ Lic.No/Date:0510350279 26.03.2013 Defer Date:10.04.2014 Decision :it was decided to remind the firm to furnish the following technical details: (a) Yield on molar basis for each step along with copy of technical literature in support of the yield envisaged. (b) BatchLog sheet for the last 3 batches. The case was deferred for 10.04.2014. 14
Case No.:4/8/82ALC4/2013
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 06.03.2014 HQ File :01/82/050/00135/AM14/ RLA File :03/95/040/00899/AM13/ Lic.No/Date:0310729960 01.04.2013 Defer Date: Decision :It was decided to reject the case as the firm has not furnished information despite repeated reminders. 15
Case No.:42/10/82ALC4/2013
Party Name:BIOLOGICAL E LTD 06.03.2014
HQ File :01/82/050/00225/AM14/ RLA File :09/24/040/00635/AM13/ Lic.No/Date:0910055653 02.04.2013 Defer Date: 16
Case No.:85/10/82ALC4/2013
Party Name:BIOLOGICAL E LTD 06.03.2014 HQ File :01/82/050/00268/AM14/ RLA File :09/24/040/00636/AM13/ Lic.No/Date:0910055652 02.04.2013 Defer Date: 17
Case No.:142/10/82ALC4/2013
Party Name:WOCKHARDT LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00325/AM14/ RLA File :03/95/040/00101/AM14/ Lic.No/Date:0310734494 15.05.2013 Defer Date:10.04.2014 Decision :The firm was requested to furnish the production and consumption data for the last three years certified by Central Excise Authority , reminder letter has been also sent on 09.01.2014. Copy of application has been already sent to DCGI for their comments. 18
Case No.:39/10/82ALC4/2013
Party Name:SCOTTEDIL PHARMACIA LTD., 06.03.2014 HQ File :01/82/050/00222/AM14/ RLA File :22/24/040/00015/AM14/ Lic.No/Date:2210013866 17.05.2013 Defer Date: 19
Case No.:42/20/82ALC4/2013
Party Name:GLAND PHARMA LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/01028/AM14/ RLA File :09/24/040/00058/AM14/ Lic.No/Date:0910056110 23.05.2013 Defer Date:10.04.2014 Decision :It was decided to request the firm to furnish Central Excise Data and also Batch Log Sheet for last 5 batches . The case was deferred for 14.04.2014. 20
Case No.:41/19/82ALC4/2013
Party Name:CIPLA LIMITED 06.03.2014 Status:Case Approved HQ File :01/82/050/00986/AM14/ RLA File :03/94/040/01130/AM13/ Lic.No/Date:0310736948 06.06.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/45/2014PI(Norms) dated 04.03.2014, 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 Exp. Qty. Sl. No. Import items Qty. allowed kg/kg RAMIPRIL Kg 1. (1S,3S,5S)2Azabicyclo (3,3,0) Octane3Carboxylic Acid benzyl ester (RMP3) 0.83 2. 5Ethoxy Carbonyl 3 Phenyl Propyl alanine 0.98 21
Case No.:156/14/82ALC4/2013
Party Name:EYTAN LABS LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00741/AM14/ RLA File :09/24/040/00087/AM14/ Lic.No/Date:0910056288 07.06.2013 Defer Date:10.04.2014 22
Case No.:77/14/82ALC4/2013
Party Name:GLAND PHARMA LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00662/AM14/ RLA File :09/24/040/00106/AM14/ Lic.No/Date:0910056304 10.06.2013 Defer Date:10.04.2014 Decision :It was decided to remind the firm to furnish Central Excise Data and also Batch Log Sheet for last 5 batches . The case was deferred for 10.04.2014. 23
Case No.:88/10/82ALC4/2013
Party Name:MAHESHRAJ CHEMICALS PVT.LTD 06.03.2014 HQ File :01/82/050/00271/AM14/ RLA File :08/24/040/00099/AM14/ Lic.No/Date:0810121913 13.06.2013 Defer Date: 24
Case No.:199/10/82ALC4/2013
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00382/AM14/ RLA File :04/24/040/00048/AM14/ Lic.No/Date:0410147196 17.06.2013 Defer Date:10.04.2014 Decision :it was decided to give last reminder the firm to furnish the following technical details:
• The firm has applied the norms from Guannosine. However, the chemistry is given from 2Amino Adenosine Stage. • Copy of technical literature in support of yields envisaged may be furnished. • Past production visavis Actual consumption of all the imported inputs duly certified by Central Excise Authority for past 3 years may be furnished The case was deferred for 10.04..2014. 25
Case No.:40/12/82ALC4/2013
Party Name:SMILAX LABORATORIES LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00464/AM14/ RLA File :09/24/040/00113/AM14/ Lic.No/Date:0910056355 17.06.2013 Defer Date:10.04.2014 26
Case No.:28/12/82ALC4/2013
Party Name:BLISS GVS PHARMA LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/00452/AM14/ RLA File :03/94/040/00245/AM14/ Lic.No/Date:0310738193 19.06.2013 Defer Date:10.04.2014 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/660/2013PI(Norms) dated 22..01.2014, it was decided to call from the firm the following technical details: 1. COA for foreign supplier indicating Potency of Nystatin imported under present A.A 2. Detailed calculation of arriving at the quantity of API applied. The case was deferred for 10.04.2014. 27
Case No.:183/10/82ALC4/2013
Party Name:VIVEK PHARMACHEM (INDIA) LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/00366/AM14/ RLA File :13/24/040/00032/AM12/ Lic.No/Date:1310043416 19.06.2013 Defer Date:10.04.2014 28
Case No.:22/12/82ALC4/2013
Party Name:INDOFIL INDUSTRIES LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/00446/AM14/ RLA File :03/94/040/00197/AM14/ Lic.No/Date:0310738404 20.06.2013 Defer Date:10.04.2014 Decision :It was decided to defer the case 10.04.2014 for comments of Department of Chemicals and Petrochemicals. 29
Case No.:126/14/82ALC4/2013
Party Name:ZIM LABORATORIES LTD. 06.03.2014 Status:Case Deferred
HQ File :01/82/050/00711/AM14/ RLA File :03/95/040/00225/AM14/ Lic.No/Date:0310738604 21.06.2013 Defer Date:14.04.2014 Decision :It was decided to defer the case 10.04.2014 for comments of Department of Chemicals and Petrochemicals. 30
Case No.:111/10/82ALC4/2013
Party Name:STERICAT GUTSTRINGS PVT. LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/00294/AM14/ RLA File :05/24/040/00091/AM14/ Lic.No/Date:0510358000 25.06.2013 Defer Date:10.04.2014 Decision :It was decided to defer the case for 10.04.2014 for comments of Department of IPP. 31
Case No.:90/14/82ALC4/2013
06.03.2014 Status:Case Deferred HQ File :01/82/050/00675/AM14/ RLA File :09/24/040/00128/AM14/ Lic.No/Date:0910056460 26.06.2013 Defer Date:10.04.2014 32
Case No.:39/12/82ALC4/2013
Party Name:RA CHEM PHARMA LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00463/AM14/ RLA File :09/24/040/00138/AM14/ Lic.No/Date:0910056466 26.06.2013 Defer Date:10.04.2014 33
Case No.:172/14/82ALC4/2013
Party Name:RECKON DIAGNOSTICS PVT. LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/00757/AM14/ RLA File :34/24/040/00044/AM14/ Lic.No/Date:3410037268 27.06.2013 Defer Date:10.04.2014 Decision :Department of Biotechnology vide their letter NO. BT/IL/05/398/2013PID dated 26.12.2013 has requested the firm to furnish the copy of Manufacturing process flow chart, copy DML (Drug Manufacturing Licence),Batch Manufacturing Record and clarification on the quantities of import inputs (whether it is in Grams or in Milligrams) mentioned in the application. The case was deferred for 10.04.2014. 34
Case No.:201/10/82ALC4/2013
Party Name:SHASUN PHARMACEUTICALS LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00384/AM14/ RLA File :04/24/040/00063/AM14/ Lic.No/Date:0410147551 27.06.2013 Defer Date:10.04.2014
Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/633/2013PI(Norms) dated 22.01.2014, it was decided to call from the firm a copy of Master Batch Formula duly certified by Quality Control Incharge. The case was deferred for 10.04.2014 35
Case No.:204/10/82ALC4/2013
Party Name:SHASUN PHARMACEUTICALS LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00387/AM14/ RLA File :04/24/040/00065/AM14/ Lic.No/Date:0410147559 27.06.2013 Defer Date:06.03.2014 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/633/2013PI(Norms) dated 22.01.2014, it was decided to call from the firm a copy of Master Batch Formula duly certified by Quality Control Incharge. The case was deferred for 10.04.2014 36
Case No.:222/10/82ALC4/2013
Party Name:ANUPAM RASAYAN (INDIA) LTD 06.03.2014 Status:Case Approved HQ File :01/82/050/00405/AM14/ RLA File :52/24/040/00009/AM14/ Lic.No/Date:5210039910 28.06.2013 Defer Date: Decision: In the light of wri埜�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/30/2013‐Ch II dated 20.02.2014, it was decided to ra韣�fy 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 3AMINO4METHYL BENZOIC ACID ISOPROPYL ESTER (AMINO BENZOIC ACID ESTER) 1 kg 1. PTOLUIC ACID (4METHYL BENZOIC ACID) 1.532 kg 2. ISOPROPYL ALCOHOL 1.17 kg 3. PER CHLORO ETHYLENE 0.214 kg 4. DIMETHYL SULFOXIDE 0.225 kg 37
Case No.:223/10/82ALC4/2013
Party Name:ANUPAM RASAYAN (INDIA) LTD 06.03.2014 Status:Case Approved HQ File :01/82/050/00406/AM14/ RLA File :52/24/040/00011/AM14/ Lic.No/Date:5210039911 28.06.2013 Defer Date: Decision :In the light of wri埜�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/30/2013‐Ch II dated 20.02.2014, it was decided to ra韣�fy 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 AMINO METHYL BENZOIC ACID CHLORO ETHYL ESTER 1 kg 1. PTOLUIC ACID (4METHYL BENZOIC ACID) 1.807 kg 2. PER CHLORO ETHYLENE 0.350 kg 3. DIMETHYL SULFOXIDE 0.300 kg 38
Case No.:224/10/82ALC4/2013
Party Name:ANUPAM RASAYAN (INDIA) LTD 06.03.2014 Status:Case Approved HQ File :01/82/050/00407/AM14/ RLA File :52/24/040/00008/AM14/ Lic.No/Date:5210039909 28.06.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/30/2013‐Ch II dated 20.02.2014, it was decided to ra韣�fy 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 2AMINO4TRIFLUORO METHYL 4 CHLORO DIPHENYL ETHER 1 kg 1. 3NITRO 4CHLORO BENZOTRIFLUORIDE 1.232 kg 2. PARA CHLORO PHENOL 0.803 kg 39
Case No.:173/14/82ALC4/2013
Party Name:ALEMBIC PHARMACEUTICALS LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/00758/AM14/ RLA File :34/24/040/00065/AM14/ Lic.No/Date:3410037281 01.07.2013 Defer Date:10.04.2014 40
Case No.:1/8/85ALC3/2013
Party Name:SRIAM LABS PRIVATE LIMITED 06.03.2014 Status: Reject HQ File :01/85/050/00054/AM14/ RLA File :09/24/040/00115/AM14/ Lic.No/Date:0910056522 01.07.2013 Defer
Date:06.03.2014 41
Case No.:24/12/82ALC4/2013
Party Name:WOCKHARDT LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00448/AM14/ RLA File :03/95/040/00256/AM14/ Lic.No/Date:0310739850 02.07.2013 Defer Date:10.04.2014 Decision :The firm was requested to furnish the production and consumption data for the last three years certified by Central Excise Authority , reminder letter has been also sent on10.04.2014. Copy of application has been already sent to DCGI for their comments. 42
Case No.:159/14/82ALC4/2013
Party Name:RUCHI INFRASTRUCTURE LTD. 06.03.2014 Status: Reject HQ File :01/82/050/00744/AM14/ RLA File :56/24/040/00010/AM14/ Lic.No/Date:5610002426 04.07.2013 Defer Date:06.03.2014 43
Case No.:44/12/82ALC4/2013
Party Name:ENCUBE ETHICALS PVT LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/00468/AM14/ RLA File :03/94/040/00306/AM14/ Lic.No/Date:0310740922 10.07.2013 Defer Date:10.04.2014 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/647/2013PI(Norms) dated 22.01.2014, it was decided to call from the firm copy of Master Batch Formula duly certified by Quality control Incharge. The case was deferred for 10.04.2014 44
Case No.:175/14/82ALC4/2013
Party Name:ONEIRO CHEMICALS LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/00760/AM14/ RLA File :34/24/040/00071/AM14/ Lic.No/Date:3410037375 10.07.2013 Defer Date:10.04.2014 Decision :It was decided to send a copy of application to Department of Pharmaceuticals for their comments. The case was deferred for 10.04.2014. 45
Case No.:160/14/82ALC4/2013
Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00745/AM14/ RLA File :04/24/040/00050/AM14/ Lic.No/Date:0410147942 11.07.2013 Defer Date:10.04.2014
46
Case No.:26/12/82ALC4/2013
Party Name:SANOFI INDIA LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00450/AM14/ RLA File :03/95/040/00227/AM14/ Lic.No/Date:0310741158 11.07.2013 Defer Date:10.04.2014 47
Case No.:5/21/82ALC4/2013
Party Name:TORRENT PHARMACEUTICALS LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01035/AM14/ RLA File :08/24/040/00157/AM14/ Lic.No/Date:0810122789 15.07.2013 Defer Date:10.04.2014 48
Case No.:60/14/82ALC4/2013
Party Name:GLAND PHARMA LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00645/AM14/ RLA File :09/24/040/00085/AM14/ Lic.No/Date:0910056772 16.07.2013 Defer Date:10.04.2014 Decision :It was decided to request the firm to furnish Central Excise Data and also Batch Log Sheet for last 5 batches . The case was deferred for 10.04.2014. 49
Case No.:21/12/82ALC4/2013
Party Name:WOCKHARDT LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00445/AM14/ RLA File :03/95/040/00306/AM14/ Lic.No/Date:0310741992 18.07.2013 Defer Date:10.04.2014 Decision :The firm was requested to furnish the production and consumption data for the last three years certified by Central Excise Authroity reminder letter has been also snet on 09.01.2014. Copy of application has been already sent to DCGI for their comments. The case was deferred for 10.04.2014. 50
Case No.:68/17/82ALC4/2013
Party Name:BHARAT PARENTERALS LTD, 06.03.2014 Status:Case Deferred HQ File :01/82/050/00930/AM14/ RLA File :34/21/040/00163/AM14/ Lic.No/Date:3410037475 23.07.2013 Defer Date:10.04.2014 51
Case No.:52/12/82ALC4/2013
Party Name:UNIJULES LIFE SCIENCES LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/00476/AM14/ RLA File :03/95/040/00305/AM14/ Lic.No/Date:0310742481 23.07.2013 Defer
Date:10.04.2014 52
Case No.:1/19/82ALC4/2013
Party Name:AUROBINDO PHARMA LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00946/AM14/ RLA File :09/24/040/00176/AM14/ Lic.No/Date:0910056894 24.07.2013 Defer Date:10.04.2014 53
Case No.:46/14/82ALC4/2013
06.03.2014 Status:Case Deferred HQ File :01/82/050/00631/AM14/ RLA File :09/24/040/00185/AM14/ Lic.No/Date:0910056909 25.07.2013 Defer Date:10.04.2014 54
Case No.:24/17/82ALC4/2013
Party Name:SMILAX LABORATORIES LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00886/AM14/ RLA File :09/24/040/00180/AM14/ Lic.No/Date:0910056902 25.07.2013 Defer Date:10.04.2014 55
Case No.:43/12/82ALC4/2013
Party Name:AMI ORGANICS PVT LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/00467/AM14/ RLA File :52/24/040/00015/AM14/ Lic.No/Date:5210040038 30.07.2013 Defer Date:10.04.2014 Decision :It was decided to send a copy of application again to Department of C&PC for their comments. The case was deferred for 10.04.2014. 56
Case No.:1/10/82ALC4/2013
Party Name:MICRO LABS LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/00184/AM14/ RLA File :07/24/040/00111/AM14/ Lic.No/Date:0710097180 30.07.2013 Defer Date:10.04.2014 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/729/2013PI(Norms) dated 04.03.2014, it was decided to call from the firm detailed justification for the import of 1039.076 kg of API against the present advance authorization. The case was deferred for 10.04.2014. 57
Case No.:22/14/82ALC4/2013
Party Name:MSN LABORATORIES PRIVATE Status:Case
LIMITED 06.03.2014 Deferred HQ File :01/82/050/00607/AM14/ RLA File :09/24/040/00192/AM14/ Lic.No/Date:0910056971 31.07.2013 Defer Date:10.04.2014 58
Case No.:48/14/82ALC4/2013
Party Name:LOUIS PHARMACEUTICALS PVT LTD Meet No/Date:23/82ALC4/2013 06.03.2014 Status:Case Deferred HQ File :01/82/050/00633/AM14/ RLA File :09/24/040/00200/AM14/ Lic.No/Date:0910057008 02.08.2013 Defer Date:10.04.2014 59
Case No.:148/14/82ALC4/2013
Party Name:SUVEN LIFE SCIENCES LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00733/AM14/ RLA File :09/24/040/00189/AM14/ Lic.No/Date:0910057006 02.08.2013 Defer Date:06.03.2014 60
Case No.:42/14/82ALC4/2013
Party Name:AVA CHEMICALS PVT.LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/00627/AM14/ RLA File :03/94/040/00220/AM14/ Lic.No/Date:0310744155 05.08.2013 Defer Date:06.03.2014 Decision :It was decided to defer the case 10.04.2014 for comments of Department of Chemicals and Petrochemicals. 61
Case No.:18/14/82ALC4/2013
Party Name:SUVEN LIFE SCIENCES LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00603/AM14/ RLA File :09/24/040/00207/AM14/ Lic.No/Date:0910057031 05.08.2013 Defer Date:10.04.2014 Decision :No Data available for the Given file number (as per case history) The case was deferred for 10.04.2014. 62
Case No.:45/14/82ALC4/2013
Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 06.03.2014 Status:Case Deferred HQ File :01/82/050/00630/AM14/ RLA File :07/24/040/00137/AM14/ Lic.No/Date:0710097392 06.08.2013 Defer Date:10.04.2014 Decision :It was decided to call from the complete technical details as per Appendix 33. The case was deferred for 10.04.2014
63
Case No.:40/14/82ALC4/2013
Party Name:CTX LIFESCIENCES PVT LTD, 06.03.2014 Status:Case Deferred HQ File :01/82/050/00625/AM14/ RLA File :03/94/040/00307/AM14/ Lic.No/Date:0310744552 07.08.2013 Defer Date:10.04.2014 Decision :It was decided to call from the firm complete technical details as per Appendix 33. The case was deferred for 10.04.2014 64
Case No.:165/14/82ALC4/2013
Party Name:MEDREICH LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00750/AM14/ RLA File :07/24/040/00135/AM14/ Lic.No/Date:0710097410 07.08.2013 Defer Date:10.04.2014 65
Case No.:34/13/82ALC4/2013
Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 06.03.2014 Status:Case Deferred HQ File :01/82/050/00510/AM14/ RLA File :03/95/040/00132/AM14/ Lic.No/Date:0310744838 12.08.2013 Defer Date:10.04.2014 66
Case No.:36/14/82ALC4/2013
Party Name:GLOBE TROTTERS PVT LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/00621/AM14/ RLA File :03/94/040/00359/AM14/ Lic.No/Date:0310745177 13.08.2013 Defer Date:10.04.2014 67
Case No.:147/14/82ALC4/2013
06.03.2014 Status:Case Deferred HQ File :01/82/050/00732/AM14/ RLA File :09/24/040/00201/AM14/ Lic.No/Date:0910057191 14.08.2013 Defer Date:10.04.2014 68
Case No.:122/14/82ALC4/2013
Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 06.03.2014 Status:Case Deferred HQ File :01/82/050/00707/AM14/ RLA File :03/95/040/00203/AM14/ Lic.No/Date:0310745264 14.08.2013 Defer Date:10.04.2014
69
Case No.:66/14/82ALC4/2013
Party Name:SRINI PHARMACEUTICALS LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/00651/AM14/ RLA File :09/24/040/00216/AM14/ Lic.No/Date:0910057203 16.08.2013 Defer Date:10.04.2014 70
Case No.:121/14/82ALC4/2013
Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 06.03.2014 Status:Case Deferred HQ File :01/82/050/00706/AM14/ RLA File :03/95/040/00505/AM13/ Lic.No/Date:0310745576 16.08.2013 Defer Date:10.04.2014 Decision :It was decided to defer the case for 10.04.2014 for comments of Department of Pharmaceuticals 71
Case No.:62/14/82ALC4/2013
Party Name:DR REDDYS LABORATORIES LIMITED 06.03.2014 Status:Case Approved HQ File :01/82/050/00647/AM14/ RLA File :09/24/040/00223/AM14/ Lic.No/Date:0910057232 19.08.2013 Defer Date: Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/731/2013PI(Norms) dated 04.03.2014, 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 Exp. Qty. Sl. No. Import items Qty. allowed Kg/kg Naproxen Sodium Kg 1. D,L2(6Methoxy2Naphthyl) Propionic Acid (DLAcid) 1.182 2. NOctylDGlucamine 0.100 72
Case No.:34/14/82ALC4/2013
Party Name:SMILAX LABORATORIES LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00619/AM14/ RLA File :09/24/040/00231/AM14/ Lic.No/Date:0910057244 19.08.2013 Defer Date:10.04.2014 73
Case No.:117/14/82ALC4/2013
Party Name:MAC CHEM PRODUCTS (INDIA) PRIVATE LIMITED 06.03.2014 Status:Case Deferred
HQ File :01/82/050/00702/AM14/ RLA File :03/95/040/00407/AM14/ Lic.No/Date:0310745962 20.08.2013 Defer Date:10.04.2014 74
Case No.:26/14/82ALC4/2013
06.03.2014 Status:Case Deferred HQ File :01/82/050/00611/AM14/ RLA File :09/24/040/00190/AM14/ Lic.No/Date:0910057247 20.08.2013 Defer Date:10.04.2014 75
Case No.:57/14/82ALC4/2013
06.03.2014 Status:Case Deferred HQ File :01/82/050/00642/AM14/ RLA File :09/24/040/00229/AM14/ Lic.No/Date:0910057251 20.08.2013 Defer Date:10.04.2014 76
Case No.:65/14/82ALC4/2013
Party Name:SRIAM LABS PRIVATE LIMITED 06.03.2014 HQ File :01/82/050/00650/AM14/ RLA File :09/24/040/00178/AM14/ Lic.No/Date:0910057260 21.08.2013 Defer Date: 77
Case No.:3/12/82ALC4/2013
Party Name:ACTAVIS PHARMA MANUFACTURING PVT.LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/00427/AM14/ RLA File :04/24/040/00095/AM14/ Lic.No/Date:0410148864 22.08.2013 Defer Date:10.04.2014 Decision :It was decided to send a copy of application again to DCGI for their comments (solution of import items contains 8% water). The case was deferred for 10.04.2014. 78
Case No.:32/14/82ALC4/2013
Party Name:ALEMBIC PHARMACEUTICALS LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/00617/AM14/ RLA File :34/24/040/00110/AM14/ Lic.No/Date:3410037709 22.08.2013 Defer Date:10.04.2014
79
Case No.:10/17/85ALC3/2013
Party Name:BELOOR BAYIR BIOTECH LTD, 06.03.2014 Status:Case Deferred HQ File :01/85/050/00113/AM14/ RLA File :07/24/040/00150/AM14/ Lic.No/Date:0710097664 22.08.2013 Defer Date:10.04.2014 80
Case No.:47/14/82ALC4/2013
Party Name:VIVIMED LABS LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00632/AM14/ RLA File :09/24/040/00251/AM14/ Lic.No/Date:0910057280 22.08.2013 Defer Date:10.04.2014 81
Case No.:152/14/82ALC4/2013
06.03.2014 Status:Case Deferred HQ File :01/82/050/00737/AM14/ RLA File :09/24/040/00211/AM14/ Lic.No/Date:0910057368 27.08.2013 Defer Date:10.04.2014 82
Case No.:116/14/82ALC4/2013
Party Name:UNIJULES LIFE SCIENCES LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/00701/AM14/ RLA File :03/95/040/00215/AM14/ Lic.No/Date:0310747079 27.08.2013 Defer Date:10.04.2014 83
Case No.:146/14/82ALC4/2013
Party Name:MACLEODS PHARMACEUTICALS LTD. 06.03.2014 Status:Case Approved HQ File :01/82/050/00731/AM14/ RLA File :03/95/040/00429/AM14/ Lic.No/Date:0310747495 29.08.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/777/2013PI(Norms) dated 04.03.2014, 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 Exp. Qty. Sl. No. Import items Qty. allowed kg/kg LEVOFLOXACIN 500MG TABLETS Kg 1. (S) 9,10DIFLUORO3 METHYL7OXO 2,3DIHYDRO7H 492.8 mg/ 500 mg Tablets
PYRIDO(1,2,3DE)1,4 BENZOXAZINE6 CARBOXYLIC ACID ETHYL ESTER 84
Case No.:51/14/82ALC4/2013
Party Name:RATNAMANI BIO CHEMICALS & PHARMACEUTICALS PVT. LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/00636/AM14/ RLA File :34/24/040/00125/AM14/ Lic.No/Date:3410037783 02.09.2013 Defer Date:10.04.2014 Decision :It was decided to defer the case 10.04.2014 for comments of Department of Chemicals and Petrochemicals. 85
Case No.:54/14/82ALC4/2013
Party Name:INDO PHYTO CHEMICALS PVT LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/00639/AM14/ RLA File :05/23/040/00233/AM14/ Lic.No/Date:0510364656 05.09.2013 Defer Date:10.04.2014 86
Case No.:29/14/82ALC4/2013
Party Name:MAITHRI LABORATORIES (P) LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/00614/AM14/ RLA File :09/24/040/00242/AM14/ Lic.No/Date:0910057495 05.09.2013 Defer Date:10.04.2014 87
Case No.:53/14/82ALC4/2013
Party Name:STERILE INDIA PRIVATE LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00638/AM14/ RLA File :05/24/040/00203/AM14/ Lic.No/Date:0510364653 05.09.2013 Defer Date:10.04.2014 88
Case No.:176/14/82ALC4/2013
Party Name:AMI LIFESCIENCES P LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/00761/AM14/ RLA File :34/24/040/00132/AM14/ Lic.No/Date:3410037845 06.09.2013 Defer Date:10.04.2014
89
Case No.:30/14/82ALC4/2013
Party Name:HONEST BIOVET PVT. LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/00615/AM14/ RLA File :08/24/040/00250/AM14/ Lic.No/Date:0810124568 06.09.2013 Defer Date:10.04.2014 90
Case No.:103/14/82ALC4/2013
Party Name:INTAS PHARMACEUTICALS LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/00688/AM14/ RLA File :08/24/040/00242/AM14/ Lic.No/Date:0810124544 06.09.2013 Defer Date:10.04.2014 91
Case No.:56/14/82ALC4/2013
Party Name:VIVEK PHARMACHEM (INDIA) LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/00641/AM14/ RLA File :13/24/040/00021/AM14/ Lic.No/Date:1310044273 09.09.2013 Defer Date:10.04.2014 92
Case No.:54/17/82ALC4/2013
Party Name:CIREX PHARMACEUTICALS LIMITED Meet No/Date:23/82ALC4/2013 06.03.2014 Status:Case Deferred HQ File :01/82/050/00916/AM14/ RLA File :09/24/040/00258/AM14/ Lic.No/Date:0910057517 10.09.2013 Defer Date:10.04.2014 93
Case No.:149/14/82ALC4/2013
Party Name:MACLEODS PHARMACEUTICALS LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/00734/AM14/ RLA File :03/95/040/00465/AM14/ Lic.No/Date:0310748925 10.09.2013 Defer Date:10.04.2014 94
Case No.:150/14/82ALC4/2013
Party Name:MACLEODS PHARMACEUTICALS LTD. 06.03.2014 Status:Case Approved HQ File :01/82/050/00735/AM14/ RLA File :03/95/040/00459/AM14/ Lic.No/Date:0310748979 Defer Date:
10.09.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/777/2013PI(Norms) dated 04.03.2014, 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 Exp. Qty. Sl. No. Import items Qty. allowed kg/kg LEVOFLOXACIN 250MG TABLETS Kg 1. (S) 9,10DIFLUORO3 METHYL7OXO 2,3DIHYDRO7H PYRIDO(1,2,3DE)1,4 BENZOXAZINE6 CARBOXYLIC ACID ETHYL ESTER 246.35 mg/ 250 mg Tablets 95
Case No.:69/14/82ALC4/2013
Party Name:ONEIRO CHEMICALS LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/00654/AM14/ RLA File :34/24/040/00138/AM14/ Lic.No/Date:3410037862 11.09.2013 Defer Date:10.04.2014 96
Case No.:63/17/82ALC4/2013
Party Name:DR REDDYS LABORATORIES LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00925/AM14/ RLA File :09/24/040/00261/AM14/ Lic.No/Date:0910057546 13.09.2013 Defer Date:10.04.2014 97
Case No.:10/16/82ALC4/2013
Party Name:STERICON PHARMA PVT.LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/00823/AM14/ RLA File :07/24/040/00201/AM14/ Lic.No/Date:0710098284 16.09.2013 Defer Date:10.04.2014
98
Case No.:151/14/82ALC4/2013
Party Name:THINQ PHARMACRO LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00736/AM14/ RLA File :03/95/040/00432/AM14/ Lic.No/Date:0310749651 16.09.2013 Defer Date:10.04.2014 99
Case No.:35/17/82ALC4/2013
Party Name:S M S PHARMACEUTICALS LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/00897/AM14/ RLA File :09/24/040/00083/AM14/ Lic.No/Date:0910057602 18.09.2013 Defer Date:10.04.2014 100
Case No.:46/16/82ALC4/2013
Party Name:SHASUN PHARMACEUTICALS LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00859/AM14/ RLA File :04/24/040/00127/AM14/ Lic.No/Date:0410149960 18.09.2013 Defer Date:10.04.2014 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/633/2013PI(Norms) dated 22.01.2014.2014, it was decided to call from the firm a copy of Master Batch Formula duly certified by Quality Control Incharge. The case was deferred for 10.04.2014 101
Case No.:49/16/82ALC4/2013
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/00862/AM14/ RLA File :04/24/040/00100/AM14/ Lic.No/Date:0410149961 18.09.2013 Defer Date:10.04.2014 102
Case No.:28/17/82ALC4/2013
Party Name:SUVEN LIFE SCIENCES LIMITED 06.03.2014 Status:Case Approved HQ File :01/82/050/00890/AM14/ RLA File :09/24/040/00267/AM14/ Lic.No/Date:0910057604 18.09.2013 Defer Date: Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/761/2013PI(Norms) dated 04.03.2014, 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 Exp. Sl. No. Import items Qty. allowed
Qty. kg/kg BENZHYDRYL THIOACETAMIDE Kg 1. HYDRO BROMIC ACID 1.20 2. THIO UREA 0.45 3. BENZHYDROL 0.99 4. 2CHLORO ACETAMIDE 0.50 103
Case No.:50/17/82ALC4/2013
Party Name:GLAND PHARMA LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00912/AM14/ RLA File :09/24/040/00294/AM14/ Lic.No/Date:0910057628 19.09.2013 Defer Date:10.04.2014 104
Case No.:68/14/82ALC4/2013
Party Name:NIFTY LABS PVT LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/00653/AM14/ RLA File :09/24/040/00283/AM14/ Lic.No/Date:0910057606 19.09.2013 Defer Date:10.04.2014 105
Case No.:64/17/82ALC4/2013
Party Name:RA CHEM PHARMA LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00926/AM14/ RLA File :09/24/040/00120/AM14/ Lic.No/Date:0910057630 19.09.2013 Defer Date:10.04.2014 106
Case No.:81/23/82ALC4/2013
Party Name:RANBAXY LABORATORIES LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/01128/AM14/ RLA File :05/24/040/00207/AM14/ Lic.No/Date:0510366184 19.09.2013 Defer Date:10.04.2014 107
Case No.:55/14/82ALC4/2013
Party Name:SAIBABA SURFACTANTS (P) LTD., 06.03.2014 Status:Case Deferred
HQ File :01/82/050/00640/AM14/ RLA File :08/24/040/00268/AM14/ Lic.No/Date:0810124942 19.09.2013 Defer Date:10.04.2014 108
Case No.:53/17/82ALC4/2013
Party Name:HETERO DRUGS LIMITED, 06.03.2014 Status:Case Deferred HQ File :01/82/050/00915/AM14/ RLA File :09/24/040/00293/AM14/ Lic.No/Date:0910057642 20.09.2013 Defer Date:10.04.2014 109
Case No.:73/23/82ALC4/2013
Party Name:ESTEEM INDUSTRIES PVT. LTD, 06.03.2014 Status:Case Deferred HQ File :01/82/050/01120/AM14/ RLA File :17/24/040/00068/AM14/ Lic.No/Date:1710005519 24.09.2013 Defer Date:10.04.2014 110
Case No.:62/17/82ALC4/2013
Party Name:SMILAX LABORATORIES LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00924/AM14/ RLA File :09/24/040/00292/AM14/ Lic.No/Date:0910057671 24.09.2013 Defer Date:10.04.2014 111
Case No.:121/23/82ALC4/2013
Party Name:STERLING HEALTHCARE LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/01168/AM14/ RLA File :31/83/040/00096/AM14/ Lic.No/Date:3110060426 24.09.2013 Defer Date:10.04.2014 112
Case No.:30/17/82ALC4/2013
Party Name:BRUNDAVAN LABORATORIES PRIVATE LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/00892/AM14/ RLA File :09/24/040/00296/AM14/ Lic.No/Date:0910057708 25.09.2013 Defer Date:10.04.2014 113
Case No.:21/19/82ALC4/2013
Party Name:GOPALDAS VISRAM & CO.LTD. Status:Case
06.03.2014 Deferred HQ File :01/82/050/00966/AM14/ RLA File :03/94/040/00502/AM14/ Lic.No/Date:0310751325 26.09.2013 Defer Date:10.04.2014 114
Case No.:25/19/82ALC4/2013
Party Name:BLUE CIRCLE ORGANICS PVT. LTD. 06.03.2014 Status:Case Approved HQ File :01/82/050/00970/AM14/ RLA File :03/94/040/00153/AM14/ Lic.No/Date:0310751581 27.09.2013 Defer Date: Decision :In the light of wri埜�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/21/2011‐Ch II dated 25.01.2014, it was decided to ra韣�fy 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 SODIUM SACCHARIN 1 kg 1. SACCHARIN INSOLUBLE 0.910 kg 115
Case No.:43/17/82ALC4/2013
Party Name:SUVEN LIFE SCIENCES LIMITED 06.03.2014 Status:Case Approved HQ File :01/82/050/00905/AM14/ RLA File :09/24/040/00307/AM14/ Lic.No/Date:0910057723 27.09.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 20/82 dated 16.01.2014, 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 Gabapentin Kg 1. CYCLOHEXANE1,1DIACETIC ACID MONOAMIDE (CDAM) 0.988 2. Acetone 0.785 116
Case No.:14/16/82ALC4/2013
Party Name:SHAMSHREE LIFESCIENCES LTD., 06.03.2014 Status:Case Deferred Lic.No/Date:2210014253
HQ File :01/82/050/00827/AM14/ RLA File :22/24/040/00046/AM14/ 30.09.2013 Defer Date:10.04.2014 117
Case No.:41/17/82ALC4/2013
Party Name:HETERO LABS LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00903/AM14/ RLA File :09/24/040/00317/AM14/ Lic.No/Date:0910057783 01.10.2013 Defer Date:10.04.2014 118
Case No.:46/17/82ALC4/2013
Party Name:INCHEM LABORATORIES PRIVATE LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00908/AM14/ RLA File :09/24/040/00288/AM14/ Lic.No/Date:0910057784 01.10.2013 Defer Date:10.04.2014 119
Case No.:48/17/82ALC4/2013
Party Name:INCHEM LABORATORIES PRIVATE LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00910/AM14/ RLA File :09/24/040/00287/AM14/ Lic.No/Date:0910057785 01.10.2013 Defer Date:10.04.2014 120
Case No.:32/16/82ALC4/2013
Party Name:FINE CURE PHARMACEUTICALS LTD. Meet No/Date:23/82ALC4/2013 06.03.2014 Status:Case Deferred HQ File :01/82/050/00845/AM14/ RLA File :08/24/040/00292/AM14/ Lic.No/Date:0810125295 03.10.2013 Defer Date:10.04.2014 121
Case No.:42/16/82ALC4/2013
Party Name:INDIA GLYCOLS LTD., 06.03.2014 Status:Case Approved HQ File :01/82/050/00855/AM14/ RLA File :05/23/040/00269/AM14/ Lic.No/Date:0510367396 03.10.2013 Defer Date: Decision :In the light of wri埜�en comments received from Petrochemical Division of Department of Chemicals and Petrochemicals vide their U.O No. 46011/89‐ A/2007‐PC‐ II dated 10.03.2014, it was decided to ra韣�fy 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
Mono Ethylene Glycol (MEG) 1 kg 1. Denatured Ethyl Alcohol 1.123 kg 2. Silver Catalyst 0.000228 kg 3. Alumina Catalyst 0.000362 kg 122
Case No.:39/16/82ALC4/2013
Party Name:SANMAR SPECIALITY CHEMICALS LIMITED, 06.03.2014 Status:Case Deferred HQ File :01/82/050/00852/AM14/ RLA File :04/24/040/00146/AM14/ Lic.No/Date:0410150519 03.10.2013 Defer Date:10.04.2014 123
Case No.:7/17/82ALC4/2013
Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/00869/AM14/ RLA File :34/24/040/00159/AM14/ Lic.No/Date:3410038104 03.10.2013 Defer Date:10.04.2014 124
Case No.:107/23/82ALC4/2013
Party Name:ESTEEM INDUSTRIES PVT. LTD, 06.03.2014 Status:Case Deferred HQ File :01/82/050/01154/AM14/ RLA File :17/24/040/00070/AM14/ Lic.No/Date:1710005529 04.10.2013 Defer Date:10.04.2014 125
Case No.:15/17/82ALC4/2013
Party Name:AGIO PHARMACEUTICALS LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/00877/AM14/ RLA File :03/94/040/00542/AM14/ Lic.No/Date:0310752494 07.10.2013 Defer Date:06.03.2014 126
Case No.:25/16/82ALC4/2013
Party Name:ATUL LIMITED, 06.03.2014 Status:Case Approved HQ File :01/82/050/00838/AM14/ RLA File :08/24/040/00244/AM14/ Lic.No/Date:0810125378 07.10.2013 Defer Date:
Decision :In the light of wri埜�en comments received from Petrochemical Division of Department of Chemicals and Petrochemicals vide their U.O No. 46011/105/2005‐PC‐ II dated 26.02.2014, it was decided to ra韣�fy 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 REACTIVE DILUENT LAPOX 1 kg 1. EPICHLOROHYDRIN ORGANIC CHEMICAL 0.920 kg 2. PHENOL ORGANIC CHEMICAL 0.941 kg 127
Case No.:34/19/82ALC4/2013
Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:23/82ALC4/2013 06.03.2014 Status:Case Deferred HQ File :01/82/050/00979/AM14/ RLA File :03/94/040/00552/AM14/ Lic.No/Date:0310752484 07.10.2013 Defer Date:10.04.2014 128
Case No.:12/16/82ALC4/2013
Party Name:INTAS PHARMACEUTICALS LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/00825/AM14/ RLA File :08/24/040/00303/AM14/ Lic.No/Date:0810125470 08.10.2013 Defer Date:10.04.2014 129
Case No.:26/16/82ALC4/2013
Party Name:INTAS PHARMACEUTICALS LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/00839/AM14/ RLA File :08/24/040/00302/AM14/ Lic.No/Date:0810125462 08.10.2013 Defer Date:10.04.2014 130
Case No.:134/23/82ALC4/2013
Party Name:MAKSON INDUSTRIES PVT. LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01181/AM14/ RLA File :03/95/040/00014/AM14/ Lic.No/Date:0310752666 08.10.2013 Defer Date:06.03.2014 131
Case No.:24/16/82ALC4/2013
Party Name:S.M. HERBALS PVT.LTD. Status:Case
06.03.2014 Deferred HQ File :01/82/050/00837/AM14/ RLA File :05/24/040/00232/AM14/ Lic.No/Date:0510367885 08.10.2013 Defer Date:10.04.2014 Decision :It was decided to call from the firm the following technical details: • COA from foreign supplier for relevant import consignment for the imported input. • COA from Independent and approved Testing Laboratory for export product. • Stepwise process with wastage envisaged in the process. The case was deferred for 10.04.2014. 132
Case No.:13/16/82ALC4/2013
Party Name:TORRENT PHARMACEUTICALS LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/00826/AM14/ RLA File :08/24/040/00296/AM14/ Lic.No/Date:0810125464 08.10.2013 Defer Date:10.04.2014 133
Case No.:18/17/82ALC4/2013
Party Name:CIPLA LIMITED 06.03.2014 Status:Deffered and Reindexed HQ File :01/82/050/00880/AM14/ RLA File :03/94/040/00591/AM14/ Lic.No/Date:0310753016 09.10.2013 Defer Date:06.03.2014 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/611/2013PI(Norms) dated 24.12.2013, 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: [A] Imports of API`s Recommended for each export product Sl. No. Export Product Export Qty. Import recommended per Tablets (Qty. In mg) Tenofovir Disoproxil Fumarate Emtricitabine Efavirenz Lamivudine 1. Tenofovir Disoproxil Fumarate 300mg/ Tablets 306.0 NIL NIL NIL 2. Tenofovir Disoproxil Fumarate 300mg + Emtricitabine 200mg Tablets 306.0 204.0 NIL NIL
Lamivudine 300mg Tenofovir Disoproxil Fumarate 300mg 306.0 NIL NIL 306.0 4. Efavirenz 600mg, Emtricitabine 200mg,Tenofovir Disoproxil Fumarate 300mg Tablets 306.0 204.0 612.0 NIL 5. Efavirenz 600mg + Tenofovir Disoproxil Fumarate300mg + Emtricitabine 200mg Tablets 306.0 204.0 612.0 NIL 6. Tenofovir Disoproxil fumarate 300mg Lamivudine 300mg Efavirenz 600mg 306.0 NIL 612.0 306.0 [B] Norms Recommended for Tenofovir Disoproxil Fumarate S. No. Import Items Qty. recommended kg/kg 1. 9[2(Phosphonyl Methoxy) Propyl] Adenine (PMPA) 0.80 2. Chloromethyl Isopropyl Carbonate 1.3527 3. NMethyl 2Pyrrolidone 1.4878 4. Fumaric Acid 0.26 5. Methylene Dichloride 6.70 6. Isopropyl Acetate 2.35 [C] Norms Recommended for Emtricitabine S. No. Import Items Qty. recommended kg/kg 1. (2R,5R)5(4amino5fluoro2oxo2HPyrimidin1yl)[1,3] oxathiolane2carboxylic acid, 2Sisopropyl5RMethyl1Rcyclohexyl ester. (FCME Compound) 2.50 2. Sodium Borohydride 0.51 3. Dipotassium Hydrogen Phosphate 3.425 [D] Norms Recommended for Lamivudine
S. No. Import Items Qty. recommended kg/kg 1. (1 R, 2 S, 5 R)MENTHYL5S(CYTOSINE1 YL)1,3 OXATHIOLANE2RCARBOXYLATE / CME COMPOUND 2.19 2. SODIUM BOROHYDRIDE 0.48 3. DIPOTASSIUM HYDROGEN PHOSPHATE 2.3684 4. SALICYLIC ACID 0.79 5. TRIETHYLAMINE 0.575 6. ETHYL ACETATE 1.795 [E] Norms Recommended for Efavirenz S. No. Import Items Qty. recommended kg/kg 1. (S)5Chloroalpha(Cyclopropylethynyl)2Aminoalpha (Trifluoromethyl) Benzenemethanol (EVI compound) 0.987 2. nHEPTANE 3.653 RA may take appropriate action as per the decision of Norms Committee. 134
Case No.:20/17/82ALC4/2013
Party Name:CIPLA LIMITED 06.03.2014 Status:Case Approved HQ File :01/82/050/00882/AM14/ RLA File :03/94/040/00588/AM14/ Lic.No/Date:0310753013 09.10.2013 Defer Date: Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/44/2014PI(Norms) dated 04.03.2014, 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: [A] Norms recommended for Lamivudine for each export product S. No. Export Product Import of Lamivudine recommended per Tablet/ per pack of oral solution (Qty. in mg) 1. Lamivudine 150mg Tablets/ Ciplabudina 150 Tab / Lamivir 150 mg Tablets 153.0 mg/tablet 2. Lamivudine Oral Solution 50mg / 5ml / ( Per Pack 100ml) 1050.0 mg/pack 3. Lamivudine Oral Solution 50mg / 5ml / ( Per Pack 2520 mg/pack
240ml) 4. Lamivudine 100mg Tablets / Lamivir Hbv Tablets [Lamivudine 100mg / Tablets ] 102.0 mg/tablet 5. Abamune L Baby Tablets / Abacavir Sulfate & Lamivudine Tablets For Oral Susp 60/30 mg 30.6 mg/tablet 6. Abamune L Junior Tablets / Abacavir Sulphate 120mg+Lamivudine 60mg Tablet 61.2 mg/tablet 7. Bivir Tablets / Duovir D Tab /Duovir Tabs Lamivudine 150mg+Zidovudine 300mg Tablets 153.0 mg/tablet 8. Cipla Lamivudine 300mg Tablet / Lamivudine Tablets 300mg 306.0 mg/tablet 9. Cipla Duovir & Efavirenz 600 Tablets /Lamivudine 150mg+Zidovudine 300mg Tablets+Efavirenz Tablets 600mg 153.0 mg/tablet 10. Cipla Lamivudine & Tenofovir 300 / 300mg Tab / Duomune Tablet / Lamivudine 300mg+Tenofovir Disoproxil Fumarate 300mg Bilayered Tablets 306.0 mg/tablet 11. Duovir N Tablet / Lamivudine 150mg+Zidovudine 300mg+Nevirapine 200mg Tablets 153.0 mg/tablet 12. Duovir N Baby / Lamivudine 30mg+Zidovudine 60mg+Nevirapine 50mg Tablets 30.6 mg/tablet 13. Lamivir S 30 Tablets / Lamivudine 150mg+Stavudine 30mg Bilayer Tablets 153.0 mg/tablet 14. Lamivir S Baby Lamivudine 30mg+Stavudine 6mg Bilayered Tablets 30.6 mg/tablet 15. Lamivir S Junior/ Lamivudine 60mg+Stavudine 12mg Bilayered Tablets 61.2 mg/tablet 16. Lamivudine And Tenofovir Disoproxil Fumarate Tab 300/300mg / Lavudine TF 306.0 mg/tablet
Lamivudine 300mg+Tenofovir Disoproxil Fumarate 300mg Bilayer Tab 17. Duovir Babay Lamivudine 30mg+Zidovudine 60mg Tablet 30.6 mg/tablet 18. Triomune 30 Tablet Lamivudine 150mg+Stavudine 30mg+Nevirapine 200mg Bilayer Tab 153.0 mg/tablet 19. Triomune40 Tab / Ciplatriomune 40 / Lamivudine 150mg+Stavudine 40mg+Nevirapine 200mg Tablets 153.0 mg/tablet 20. Triomune Baby Tablet Stavudine 6mg+Lamivudine 30mg+Nevirapine 50mg Bilayered Dispersible Tablets 30.6 mg/tablet 21. Triomune Junior Tablet Stavudine 12mg+Lamivudine 60mg+Nevirapine 100mg Bilayered Dispersible Tablets 61.2 mg/tablet [B] Norms recommended for Lamivudine S. No. Import Items Qty. recommended kg/kg 1. (1R, 2 S, 5 R)MENTHYL5S(CYTOSINE1 YL)1,3 OXATHIOLANE2RCARBOXYLATE / CME COMPOUND 2.19 2. SODIUM BOROHYDRIDE 0.48 3. DIPOTASSIUM HYDROGEN PHOSPHATE 2.3684 4. SALICYLIC ACID 0.79 5. TRIETHYLAMINE 0.575 6. ETHYL ACETATE 1.795 RA may take appropriate action as per the decision of Norms Committee. 135
Case No.:21/17/82ALC4/2013
Party Name:CIPLA LIMITED 06.03.2014 Status:Case Approved HQ File :01/82/050/00883/AM14/ RLA File :03/94/040/00601/AM14/ Lic.No/Date:0310753018 09.10.2013 Defer Date: Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/42/2014PI(Norms) dated 04.03.2014, 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 Exp. Qty. Sl. No. Import items Qty. allowed kg/kg EXEMESTANE Kg 1. Androstenedione 2.38 2. Dichloro Dicyano Benzoquinone (DDQ) 1.70 136
Case No.:27/17/82ALC4/2013
Party Name:EYTAN LABS LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00889/AM14/ RLA File :09/24/040/00340/AM14/ Lic.No/Date:0910057882 09.10.2013 Defer Date:10.04.2014 137
Case No.:122/23/82ALC4/2013
Party Name:MELZER CHEMICALS PVT. LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/01169/AM14/ RLA File :31/83/040/00116/AM14/ Lic.No/Date:3110060644 09.10.2013 Defer Date:10.04.2014 138
Case No.:73/14/82ALC4/2013
Party Name:MSN LABORATORIES PRIVATE LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00658/AM14/ RLA File :09/24/040/00325/AM14/ Lic.No/Date:0910057878 09.10.2013 Defer Date:10.04.2014 139
Case No.:36/17/82ALC4/2013
06.03.2014 Status:Case Deferred HQ File :01/82/050/00898/AM14/ RLA File :09/24/040/00300/AM14/ Lic.No/Date:0910057877 09.10.2013 Defer Date:10.04.2014 140
Case No.:28/16/82ALC4/2013
Party Name:NECTAR LIFESCIENCES LIMITED, 06.03.2014 Status:Case Deferred HQ File :01/82/050/00841/AM14/ RLA File :22/24/040/00048/AM14/ Lic.No/Date:2210014277 09.10.2013 Defer
Date:10.04.2014 141
Case No.:6/17/82ALC4/2013
Party Name:AMI ORGANICS PVT LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/00868/AM14/ RLA File :52/24/040/00024/AM14/ Lic.No/Date:5210040263 10.10.2013 Defer Date:10.04.2014 142
Case No.:135/23/82ALC4/2013
Party Name:N S CHEMICALS 06.03.2014 Status:Case Deferred HQ File :01/82/050/01182/AM14/ RLA File :03/95/040/00535/AM14/ Lic.No/Date:0310753107 10.10.2013 Defer Date:10.04.2014 143
Case No.:55/17/82ALC4/2013
Party Name:SHODHANA LABORATORIES LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/00917/AM14/ RLA File :09/24/040/00315/AM14/ Lic.No/Date:0910057889 10.10.2013 Defer Date:10.04.2014 144
Case No.:136/23/82ALC4/2013
Party Name:MANGALAM DRUGS & ORGANICS LIMITED 06.03.2014 Status:Case Approved HQ File :01/82/050/01183/AM14/ RLA File :03/95/040/00455/AM14/ Lic.No/Date:0310753226 11.10.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/526/2012PI(Norms) dated 26.09.2013, 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 Exp. Qty. Sl. No. Import items Qty. allowed kg/kg ARTEMETHER Kg 1. ARTEMISININ 1.235 2. SODIUM BOROHYDRIDE 0.188 3. TRIMETHYL ORTHO ACETATE Not shown in process
145
Case No.:137/23/82ALC4/2013
Party Name:MANGALAM DRUGS & ORGANICS LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/01184/AM14/ RLA File :03/95/040/00454/AM14/ Lic.No/Date:0310753231 11.10.2013 Defer Date:10.04.2014 146
Case No.:37/17/82ALC4/2013
06.03.2014 Status:Case Deferred HQ File :01/82/050/00899/AM14/ RLA File :09/24/040/00316/AM14/ Lic.No/Date:0910057908 11.10.2013 Defer Date:10.04.2014 147
Case No.:38/16/82ALC4/2013
Party Name:INTAS PHARMACEUTICALS LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/00851/AM14/ RLA File :08/24/040/00321/AM14/ Lic.No/Date:0810125616 14.10.2013 Defer Date:10.04.2014 148
Case No.:38/17/82ALC4/2013
06.03.2014 Status:Case Deferred HQ File :01/82/050/00900/AM14/ RLA File :09/24/040/00322/AM14/ Lic.No/Date:0910057914 14.10.2013 Defer Date:10.04.2014 149
Case No.:18/16/82ALC4/2013
Party Name:NEULAND LABORATORIES LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/00831/AM14/ RLA File :09/24/040/00323/AM14/ Lic.No/Date:0910057916 14.10.2013 Defer Date:10.04.2014 150
Case No.:133/23/82ALC4/2013
Party Name:STERLING AUXILIARIES PVT LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/01180/AM14/ RLA File :03/95/040/00501/AM14/ Lic.No/Date:0310753527 14.10.2013 Defer Date:10.04.2014
Decision : It was decided to defer the case for 10.04.2014 for comments of Department of C&PC. 151
Case No.:39/17/82ALC4/2013
Party Name:ASTRIX LABORATORIES LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/00901/AM14/ RLA File :09/24/040/00312/AM14/ Lic.No/Date:0910057944 17.10.2013 Defer Date:10.04.2014 152
Case No.:22/17/82ALC4/2013
Party Name:ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00884/AM14/ RLA File :03/94/040/00458/AM14/ Lic.No/Date:0310753955 17.10.2013 Defer Date:10.04.2014 153
Case No.:67/17/82ALC4/2013
Party Name:COVALENT LABORATORIES PRIVATE LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00929/AM14/ RLA File :09/24/040/00286/AM14/ Lic.No/Date:0910057945 17.10.2013 Defer Date:10.04.2014 154
Case No.:23/17/82ALC4/2013
Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:23/82ALC4/2013 06.03.2014 Status:Case Approved HQ File :01/82/050/00885/AM14/ RLA File :03/94/040/00586/AM14/ Lic.No/Date:0310754273 18.10.2013 Defer Date: Decision :Committee considered the case as per agenda and in light of earlier decision taken in 29/82 meeting held on 18.10.2011 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed Niclosamide Piperazine Salt 1kg. 1. Salicylic acid 0.65kg 2. Triethylamine 0.26kg 3. Piperazine Anhydrous 0.13kg 4. Thionyl chloride 0.20kg 5. IPA 0.30kg RA concerned may take further necessary ac韣�on as per above decision of Norms Commi埜�ee.
155
Case No.:5/17/82ALC4/2013
Party Name:TIDE INDUSTRIES 06.03.2014 Status:Case Deferred HQ File :01/82/050/00867/AM14/ RLA File :34/24/040/00177/AM14/ Lic.No/Date:3410038223 18.10.2013 Defer Date:10.04.2014 156
Case No.:58/17/82ALC4/2013
Party Name:INDSWIFT LABORATORIES LTD., 06.03.2014 Status:Case Approved HQ File :01/82/050/00920/AM14/ RLA File :22/24/040/00052/AM14/ Lic.No/Date:2210014299 21.10.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/535/2012PI(Norms) dated 27.12.2012, 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: Item of Export Quan韣�ty S,No Item of Import Quan韣�ty allowed kg/kg Nitazoxanide 1 kg 1. Methylene Chloride 3.17 2. 2(Acetyloxy)Benzoic Acid (Aspirin) 0.916 3. N,N Dimethyl Formamide 0.069 4. Thionyl Chloride 0.92 5. 2Amino5Nitro Thiazole 0.59 6. Triethylamine 0.1288 7 Acetone 2.00 157
Case No.:59/17/82ALC4/2013
Party Name:INDSWIFT LABORATORIES LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/00921/AM14/ RLA File :22/24/040/00050/AM14/ Lic.No/Date:2210014300 21.10.2013 Defer Date:10.04.2014 158
Case No.:73/17/82ALC4/2013
Party Name:RELIANCE INDUSTRIES LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/00935/AM14/ RLA File :03/95/040/00515/AM14/ Lic.No/Date:0310754530 21.10.2013 Defer Date:06.03.2014 Decision :It was decided to defer the case for 10.04.2014 for comments of Department of C&PC(PC Divi).
159
Case No.:108/23/82ALC4/2013
Party Name:SYMBIOTEC PHARMALAB LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/01155/AM14/ RLA File :56/24/040/00020/AM14/ Lic.No/Date:5610003035 21.10.2013 Defer Date:10.04.2014 Decision :It was decided to defer the case for 10.04.2014 for comments of Department of C&PC. 160
Case No.:106/23/82ALC4/2013
Party Name:ESTEEM INDUSTRIES PVT. LTD, 06.03.2014 Status:Case Deferred HQ File :01/82/050/01153/AM14/ RLA File :17/24/040/00074/AM14/ Lic.No/Date:1710005551 22.10.2013 Defer Date:10.04.2014 161
Case No.:60/17/82ALC4/2013
Party Name:SHAMSHREE LIFESCIENCES LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/00922/AM14/ RLA File :22/24/040/00051/AM14/ Lic.No/Date:2210014319 24.10.2013 Defer Date:10.04.2014 162
Case No.:138/23/82ALC4/2013
Party Name:MIDAS CARE PHARMACEUTICALS PVT LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/01185/AM14/ RLA File :03/95/040/00599/AM14/ Lic.No/Date:0310755504 25.10.2013 Defer Date:10.04.2014 163
Case No.:100/23/82ALC4/2013
Party Name:SYMBIOTEC PHARMALAB LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/01147/AM14/ RLA File :56/24/040/00025/AM14/ Lic.No/Date:5610003085 25.10.2013 Defer Date:10.04.2014 164
Case No.:36/19/82ALC4/2013
Party Name:SOHAM ORGANICS PVT LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/00981/AM14/ RLA File :31/83/040/00124/AM14/ Lic.No/Date:3110060943 29.10.2013 Defer Date:10.04.2014
165
Case No.:6/19/82ALC4/2013
Party Name:IPCA LABORATORIES LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00951/AM14/ RLA File :03/94/040/00632/AM14/ Lic.No/Date:0310756255 30.10.2013 Defer Date:10.03.2014 166
Case No.:78/23/82ALC4/2013
Party Name:AMI ORGANICS PVT LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01125/AM14/ RLA File :52/24/040/00031/AM14/ Lic.No/Date:5210040368 31.10.2013 Defer Date:10.03.2014 167
Case No.:130/23/82ALC4/2013
Party Name:BALAJI AMINES LIMITED 06.03.2014 Status:Case Approved HQ File :01/82/050/01177/AM14/ RLA File :31/83/040/00137/AM14/ Lic.No/Date:3110060974 01.11.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/122/2011‐Ch II dated 24.12.2013, it was decided to ra韣�fy 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 DIETHYL AMINO ETHANOL 1 kg 1. ETHANOL 0.834 kg 2. AMMONIA ANHYDROUS 0.154 kg 3. ETHYLENE OXIDE 0.395 kg 168
Case No.:14/19/82ALC4/2013
Party Name:BLISS GVS PHARMA LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/00959/AM14/ RLA File :03/94/040/00687/AM14/ Lic.No/Date:0310756546 01.11.2013 Defer Date:10.04.2014 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/660/2013PI(Norms) dated 22..01.2014, it was decided to call from the firm the following technical details: 1. COA for foreign supplier indicating Potency of Nystatin imported under present A.A
2. Detailed calculation of arriving at the quantity of API applied. The case was deferred for 10.04..2014 169
Case No.:9/21/82ALC4/2013
Party Name:YASHO INDUSTRIES PVT.LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01039/AM14/ RLA File :03/95/040/00617/AM14/ Lic.No/Date:0310756660 01.11.2013 Defer Date:10.04.2014 170
Case No.:3/16/82ALC4/2013
Party Name:AUROBINDO PHARMA LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00816/AM14/ RLA File :09/24/040/00366/AM14/ Lic.No/Date:0910058142 05.11.2013 Defer Date:10.04.2014 171
Case No.:2/19/82ALC4/2013
Party Name:GLENMARK GENERICS LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00947/AM14/ RLA File :03/94/040/00668/AM14/ Lic.No/Date:0310756884 06.11.2013 Defer Date:10.04.2014 172
Case No.:109/23/82ALC4/2013
Party Name:AMI LIFESCIENCES P LTD 06.03.2014 Status:Case Approved HQ File :01/82/050/01156/AM14/ RLA File :34/24/040/00199/AM14/ Lic.No/Date:3410038409 11.11.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 20/82 dated 16.01.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export Product 1. RUTOSIDE TRIHYDRATE EP EP ………………….1 kg 2. QUERCETIN DIHYDRATE …………………0.445 kg Sl.No Import Item Quan韣�ty allowed kg/kg 1. FAVA POWDER (RUTIN‐30%) 5.27 kg 2. CRUDE RUTIN (UNCARIA) 0.42 kg
ASSAY BY HPLC : Between 85 % to 92 % ON ANHYDROUS BASIS 173
Case No.:110/23/82ALC4/2013
Party Name:AMI LIFESCIENCES P LTD 06.03.2014 Status:Case Approved HQ File :01/82/050/01157/AM14/ RLA File :34/24/040/00200/AM14/ Lic.No/Date:3410038410 11.11.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 20/82 dated 16.01.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export Product 1. RUTOSIDE TRIHYDRATE EP EP ………………….1 kg 2. QUERCETIN DIHYDRATE …………………0.445 kg Sl.No Import Item Quan韣�ty allowed kg/kg 1. FAVA POWDER (RUTIN‐30%) 5.27 kg 2. CRUDE RUTIN (UNCARIA) ASSAY BY HPLC : Between 85 % to 92 % ON ANHYDROUS BASIS 0.42 kg 174
Case No.:33/17/82ALC4/2013
Party Name:EMCURE PHARMACEUTICALS LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/00895/AM14/ RLA File :31/83/040/00149/AM14/ Lic.No/Date:3110061033 11.11.2013 Defer Date:10.04.2014 175
Case No.:79/23/82ALC4/2013
Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/01126/AM14/ RLA File :52/24/040/00028/AM14/ Lic.No/Date:5210040395 13.11.2013 Defer Date:10.04.2014 176
Case No.:80/23/82ALC4/2013
Party Name:MAHAVIR SYNTHESIS PRIVATE Status:Case
LIMITED 06.03.2014 Deferred HQ File :01/82/050/01127/AM14/ RLA File :52/24/040/00032/AM14/ Lic.No/Date:5210040396 13.11.2013 Defer Date:10.04.2014 177
Case No.:3/19/82ALC4/2013
Party Name:SIRMAXO CHEMICALS PVT LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/00948/AM14/ RLA File :03/95/040/00625/AM14/ Lic.No/Date:0310757730 13.11.2013 Defer Date:10.03.2014 Decision :It was decided to defer the case for 10.04.2014 for comments of Department of Pharmaceuticals. It was decided to defer the case for 10.04.2014 for comments of Department of Pharmaceuticals. 178
Case No.:6/23/82ALC4/2013
Party Name:AMINES & PLASTICIZERS LIMITED 06.03.2014 Status:Case Approved HQ File :01/82/050/01053/AM14/ RLA File :03/94/040/00710/AM14/ Lic.No/Date:0310757925 14.11.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/61/2013‐Ch II dated 09.01.2014, it was decided to ra韣�fy 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 AMINOSOL CST 115 1 kg 1. PIPERAZINE (N,N DIETHYLENEDIAMINE) 68% 0.227 kg 179
Case No.:7/23/82ALC4/2013
Party Name:JESONS INDUSTRIES LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01054/AM14/ RLA File :03/94/040/00713/AM14/ Lic.No/Date:0310757929 14.11.2013 Defer Date:10.04.2014 Decision : It was decided to defer the case for 10.04.2014 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals. 180
Case No.:66/23/82ALC4/2013
Party Name:STERICON PHARMA PVT.LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/01113/AM14/ RLA File :07/24/040/00259/AM14/ Lic.No/Date:0710099690 18.11.2013 Defer Date:10.04.2014
Decision : It was decided to defer the case for 10.04.2014 for comments of Department of Pharmaceuticals. 181
Case No.:45/17/82ALC4/2013
Party Name:TORRENT PHARMACEUTICALS LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/00907/AM14/ RLA File :08/24/040/00352/AM14/ Lic.No/Date:0810126495 18.11.2013 Defer Date:10.04.2014 182
Case No.:114/23/82ALC4/2013
Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER 06.03.2014 Status:Case Approved HQ File :01/82/050/01161/AM14/ RLA File :05/23/040/00339/AM14/ Lic.No/Date:0510371306 20.11.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/7/2011‐Ch II dated 05.03.2013, it was decided to ra韣�fy 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 Benzenepropanamide, N,N1,6 Hexanediylbis [1,1 Dimethylethyl)4hydroxy (Kinox 98) 1 kg 1. Hexamethylenediamine (HMD) 0.210 kg 2. 2,6Di Tert butyl Phenol (2,6 DTBP) 0.888 kg 3. Methyl Acrylate (MA) 0.375 kg 4. Methanol 0.300 kg 5. Ortho Xylene 0.400 kg 183
Case No.:40/19/82ALC4/2013
Party Name:INDO PHYTO CHEMICALS PVT LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/00985/AM14/ RLA File :05/23/040/00334/AM14/ Lic.No/Date:0510371304 20.11.2013 Defer Date:10.04.2014 184
Case No.:10/17/82ALC4/2013
Party Name:RA CHEM PHARMA LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/00872/AM14/ RLA File :09/24/040/00407/AM14/ Lic.No/Date:0910058254 20.11.2013 Defer Date:10.04.2014
185
Case No.:111/23/82ALC4/2013
Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/01158/AM14/ RLA File :34/24/040/00202/AM14/ Lic.No/Date:3410038488 20.11.2013 Defer Date:10.04.2014 186
Case No.:99/23/82ALC4/2013
Party Name:ESTEEM INDUSTRIES PVT. LTD, 06.03.2014 Status:Case Deferred HQ File :01/82/050/01146/AM14/ RLA File :17/24/040/00080/AM14/ Lic.No/Date:1710005576 21.11.2013 Defer Date:10.04.2014 187
Case No.:119/23/82ALC4/2013
Party Name:RATNAMANI BIO CHEMICALS & PHARMACEUTICALS PVT. LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/01166/AM14/ RLA File :34/24/040/00207/AM14/ Lic.No/Date:3410038507 21.11.2013 Defer Date:10.04.2014 188
Case No.:11/17/82ALC4/2013
Party Name:SPAK ORGOCHEM (INDIA) PVT. LTD. 06.03.2014 Status:Case Approved HQ File :01/82/050/00873/AM14/ RLA File :03/95/040/00573/AM14/ Lic.No/Date:0310758641 21.11.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/5/2009‐Ch II dated 07.03.2014, it was decided to ra韣�fy 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 Sorbitan Mono Laurate 1 kg 1. Palm Kernel Fatty Acid/Coconut Fatty Acid 0.660 kg 5. Sorbitol 70% 0.710 kg
189
Case No.:74/23/82ALC4/2013
Party Name:SWISS EXPORTS PVT. LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01121/AM14/ RLA File :08/24/040/00351/AM14/ Lic.No/Date:0810126591 21.11.2013 Defer Date:06.03.2014 190
Case No.:140/23/82ALC4/2013
Party Name:UNITED PHOSPHORUS LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01187/AM14/ RLA File :03/95/040/00495/AM14/ Lic.No/Date:0310758627 21.11.2013 Defer Date:10.04.2014 191
Case No.:149/23/82ALC4/2013
Party Name:YASHO INDUSTRIES PVT.LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01196/AM14/ RLA File :03/95/040/00658/AM14/ Lic.No/Date:0310758646 21.11.2013 Defer Date:10.04.2014 192
Case No.:2/23/82ALC4/2013
Party Name:CROWN CHEMICALS PVT.LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/01049/AM14/ RLA File :03/94/040/00735/AM14/ Lic.No/Date:0310758837 22.11.2013 Defer Date:10.04.2014 193
Case No.:101/23/82ALC4/2013
Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 06.03.2014 Status:Case Deferred HQ File :01/82/050/01148/AM14/ RLA File :07/24/040/00269/AM14/ Lic.No/Date:0710099923 25.11.2013 Defer Date:10.04.2014 194
Case No.:67/23/82ALC4/2013
Party Name:ALEMBIC PHARMACEUTICALS LTD 06.03.2014 Status:Case Approved HQ File :01/82/050/01114/AM14/ RLA File :34/24/040/00213/AM14/ Lic.No/Date:3410038534 25.11.2013 Defer Date: Decision :In the light of earlier decision taken in meeting no. 14/82 dated 31.07.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per
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. Ac韣�vated Carbon 0.01 kg 9. Pla韣�num Catalyst with base Ac韣�vated Carbon 0.001 kg RA may take appropriate action as per the decision of Norms Committee. 195
Case No.:105/23/82ALC4/2013
Party Name:R L FINE CHEM 06.03.2014 Status:Case Deferred HQ File :01/82/050/01152/AM14/ RLA File :07/24/040/00264/AM14/ Lic.No/Date:0710099933 25.11.2013 Defer Date:10.04.2014 196
Case No.:139/23/82ALC4/2013
Party Name:YASHO INDUSTRIES PVT.LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01186/AM14/ RLA File :03/95/040/00673/AM14/ Lic.No/Date:0310758995 25.11.2013 Defer Date:10.04.2014 Decision : It was decided to defer the case for 10.04.2014 for comments of Department of C&PC. 197
Case No.:1/23/82ALC4/2013
Party Name:CROWN CHEMICALS PVT.LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/01048/AM14/ RLA File :03/94/040/00733/AM14/ Lic.No/Date:0310759268 26.11.2013 Defer Date:10.04.2014 198
Case No.:3/23/82ALC4/2013
Party Name:CROWN CHEMICALS PVT.LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/01050/AM14/ RLA File :03/94/040/00734/AM14/ Lic.No/Date:0310759273 Defer
26.11.2013 Date:10.04.2014 Decision :It was decided to defer the case for 10.04.2014 for comments of Department of C&PV. 199
Case No.:129/23/82ALC4/2013
Party Name:HETERO LABS LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/01176/AM14/ RLA File :09/24/040/00421/AM14/ Lic.No/Date:0910058346 26.11.2013 Defer Date:10.04.2014 200
Case No.:132/23/82ALC4/2013
Party Name:NECTAR LIFESCIENCES LIMITED, 06.03.2014 Status:Case Deferred HQ File :01/82/050/01179/AM14/ RLA File :22/24/040/00063/AM14/ Lic.No/Date:2210014401 26.11.2013 Defer Date:06.03.2014 201
Case No.:4/21/82ALC4/2013
Party Name:DIVIS LABORATORIES LTD., 06.03.2014 Status:Case Approved HQ File :01/82/050/01034/AM14/ RLA File :09/24/040/00411/AM14/ Lic.No/Date:0910058365 27.11.2013 Defer Date: Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/646/2013PI(Norms) dated 04.03.2014, 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: Item of Export Quan韣�ty S,No Item of Import Quan韣�ty allowed kg/kg IOPAMIDOL (Tech) 1 kg 1. ATIPA DI CHLORIDE 1.26 2. 2ACETOXY PROPIONYL CHLORIDE 0.441 3. DI METHYL FORMAMIDE 0.702 4. ISO PROPYL ALCOHOL 7.317 5. METHANOL 2.889 6. N,NDI METHYL ACETAMIDE 1.314 7. NITRO METHANE 0.432 8. TOLUENE 0.90 202
Case No.:70/23/82ALC4/2013
Party Name:LAKE CHEMICALS PRIVATE LIMITED Meet No/Date:23/82ALC4/2013 06.03.2014 Status:Case Approved
HQ File :01/82/050/01117/AM14/ RLA File :07/24/040/00272/AM14/ Lic.No/Date:0710100027 27.11.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 1/82 dated 04.04.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Export Qty. Sl.No. Import items Qty. allowed Bromazepam 1 kg 1. 2Amino Benzonitrile 0.99 kg 203
Case No.:76/23/82ALC4/2013
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/01123/AM14/ RLA File :04/24/040/00161/AM14/ Lic.No/Date:0410152306 27.11.2013 Defer Date:06.03.2014 204
Case No.:77/23/82ALC4/2013
Party Name:SHASUN PHARMACEUTICALS LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/01124/AM14/ RLA File :04/24/040/00183/AM14/ Lic.No/Date:0410152258 27.11.2013 Defer Date:10.04.2014 205
Case No.:4/23/82ALC4/2013
Party Name:DELTA FINOCHEM PVT.LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01051/AM14/ RLA File :03/94/040/00514/AM14/ Lic.No/Date:0310759628 28.11.2013 Defer Date:10.04.2014 206
Case No.:94/23/82ALC4/2013
Party Name:DHANUKA LABORATORIES LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01141/AM14/ RLA File :05/23/040/00342/AM14/ Lic.No/Date:0510372219 28.11.2013 Defer Date:10.04.2014 Decision : It was decided to defer the case for 10.04.2014 for comments of Department of Pharmaceuticals. 207
Case No.:75/23/82ALC4/2013
Party Name:PCL OIL & SOLVENTS LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/01122/AM14/ RLA File :05/24/040/00221/AM14/ Lic.No/Date:0510372153 Defer
28.11.2013 Date:10.04.2014 208
Case No.:141/23/82ALC4/2013
Party Name:NOCIL LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/01188/AM14/ RLA File :03/95/040/00684/AM14/ Lic.No/Date:0310759810 29.11.2013 Defer Date:10.04.2014 Decision : It was decided to defer the case for 10.04.2014 for comments of Department of C&PC. 209
Case No.:102/23/82ALC4/2013
Party Name:OTSUKA CHEMICAL ( INDIA ) PRIVATE LIMITED 06.03.2014 Status:Case Approved HQ File :01/82/050/01149/AM14/ RLA File :05/24/040/00288/AM14/ Lic.No/Date:0510372248 29.11.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 11/82 dated 05.09.2013, 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: Item of Export Quantity S.No Item of Import Quantity Allowed kg/kg 7Phenylacetamideo3 Chloromethyl Cephalosporanic Acid Para Methoxybenzyl Ester (GCLE) While/Light Yellow Powder 1 kg 1. Penicillin G Potassium 1stCrystals 2.85 2. Methanol 2.00 3. Dimethyl Formamide 3.86 4. Methylene Chloride 2.09 5. 2Mercaptobenzothiazole 0.511 6. Isopropyl Alcohol 1.25 210
Case No.:104/23/82ALC4/2013
Party Name:PCL OIL & SOLVENTS LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/01151/AM14/ RLA File :05/24/040/00201/AM14/ Lic.No/Date:0510372321 29.11.2013 Defer Date:06.03.2014 Decision :It was decided to defer the case for 10.04.2014 for comments of Department of C&PC 211
Case No.:5/23/82ALC4/2013
Party Name:ARIHANTANAM LIFECARE PVT. LTD. Meet No/Date:23/82ALC4/2013 06.03.2014 Status:Case Deferred HQ File :01/82/050/01052/AM14/ RLA File :03/94/040/00759/AM14/ Lic.No/Date:0310760168 02.12.2013 Defer Date:06.03.2014
212
Case No.:148/23/82ALC4/2013
Party Name:CTX LIFESCIENCES PVT LTD, 06.03.2014 Status:Case Deferred HQ File :01/82/050/01195/AM14/ RLA File :03/94/040/00598/AM14/ Lic.No/Date:0310760166 02.12.2013 Defer Date:10.04.2014 213
Case No.:113/23/82ALC4/2013
Party Name:MARCK BIOSCIENCES LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01160/AM14/ RLA File :08/24/040/00385/AM14/ Lic.No/Date:0810126809 02.12.2013 Defer Date:10.04.2014 Decision : It was decided to defer the case for 10.04.2014 for comments of Department of Pharmaceuticals. 214
Case No.:103/23/82ALC4/2013
Party Name:R L FINE CHEM 06.03.2014 Status:Case Approved HQ File :01/82/050/01150/AM14/ RLA File :07/24/040/00265/AM14/ Lic.No/Date:0710100167 02.12.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 16/82 dated 21.11.2013, 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 Clomipramine Hcl 1 Kg. 1. 1 Bromo 3 Chloro Propane 0.85 kg 2. 3 Chloro Iminodibenzyl 0.91 kg 215
Case No.:13/23/82ALC4/2013
Party Name:YASHO INDUSTRIES PVT.LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01060/AM14/ RLA File :03/95/040/00696/AM14/ Lic.No/Date:0310759990 02.12.2013 Defer Date:10.04.2014 216
Case No.:147/23/82ALC4/2013
Party Name:AGIO PHARMACEUTICALS LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/01194/AM14/ RLA File :03/94/040/00705/AM14/ Lic.No/Date:0310760371 03.12.2013 Defer Date:10.04.2014
217
Case No.:150/23/82ALC4/2013
Party Name:AGIO PHARMACEUTICALS LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/01197/AM14/ RLA File :03/94/040/00706/AM14/ Lic.No/Date:0310760378 03.12.2013 Defer Date:10.04.2014 Decision : It was decided to defer the case for 10.04.2014 for comments of Department of Pharmaceuticals. 218
Case No.:152/23/82ALC4/2013
Party Name:ALTA LABORATORIES LTD. 06.03.2014 Status:Case Approved HQ File :01/82/050/01199/AM14/ RLA File :03/94/040/00724/AM14/ Lic.No/Date:0310760282 03.12.2013 Defer Date: Decision : In the light of earlier decision taken in mee韣�ng no. 31/82 dated 21.02.2013, it was decided to ra韣�fy 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 item Qty. allowed Sodium Salicylate 1 Kg. 1. Salicylic Acid 0.80 kg 219
Case No.:151/23/82ALC4/2013
Party Name:IPCA LABORATORIES LIMITED 06.03.2014 Status:Case Approved HQ File :01/82/050/01198/AM14/ RLA File :03/94/040/00731/AM14/ Lic.No/Date:0310760279 03.12.2013 Defer Date: Decision : In the light of earlier decision taken in mee韣�ng no. 21/82 dated 04.10.2012, it was decided to ra韣�fy 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 Paroxetine Hydrochloride Hemihydrate 1 kg 1. ()Trans4R(4 Fluorophenyl)3S HydroxymthylN Methyl Piperidine 0.9511 kg 2. Sesamol 0.55 kg 3. Dimethyl Sulfoxide 2.9293 kg Ra may take appropriate action as per the decision of Norms Committee.
220
Case No.:12/23/82ALC4/2013
Party Name:MOHINI ORGANICS PVT. LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/01059/AM14/ RLA File :03/95/040/00631/AM14/ Lic.No/Date:0310760264 03.12.2013 Defer Date:10.04.2014 221
Case No.:142/23/82ALC4/2013
Party Name:NOCIL LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/01189/AM14/ RLA File :03/95/040/00554/AM14/ Lic.No/Date:0310760329 03.12.2013 Defer Date:10.04.2014 222
Case No.:72/17/82ALC4/2013
Party Name:RA CHEM PHARMA LIMITED 06.03.2014 Status:Case Approved HQ File :01/82/050/00934/AM14/ RLA File :09/24/040/00413/AM14/ Lic.No/Date:0910058435 03.12.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 52/82 dated 27.03.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export Product Export Quantity S.No. Import Product Quantity Allowed kg/kg Oxolamine Citrate 1 kg 1. 3Chlorpropionyl Chloride 1.16 2. Benzonitrile 1.00 Ra may take appropriate action as per the decision of Norms Committee. 223
Case No.:98/23/82ALC4/2013
Party Name:CADILA HEALTHCARE LTD., 06.03.2014 Status:Case Approved HQ File :01/82/050/01145/AM14/ RLA File :08/24/040/00345/AM14/ Lic.No/Date:0810126890 04.12.2013 Defer Date: Decision :In the light of earlier decision taken in meeting no. 18/82 dated 19.12.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export Product: POTASSIUM CITRATE EXTENDED RELEASE TABLETS S.NO. Import Items For export of 1 Million No. Tablets
5 m Eq 10.0m Eq 15.0m Eq 1. POTASSIUM CITRATE USP 550.8 kg 1101.60 kg 1652.40 kg 2. CARNAUBA WAX (EZCOAT CWM) NF 137.85 275.70 290.0 3 to 7 Bottles and Caps Relevant as per packing policy 224
Case No.:112/23/82ALC4/2013
Party Name:CADILA HEALTHCARE LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/01159/AM14/ RLA File :08/24/040/00387/AM14/ Lic.No/Date:0810126887 04.12.2013 Defer Date:10.04.2014 225
Case No.:15/23/82ALC4/2013
Party Name:MELOG SPECIALITY CHEMICALS PVT. LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01062/AM14/ RLA File :03/95/040/00700/AM14/ Lic.No/Date:0310760526 04.12.2013 Defer Date:10.04.2014 226
Case No.:116/23/82ALC4/2013
Party Name:ALCHEM INTERNATIONAL LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01163/AM14/ RLA File :05/23/040/00341/AM14/ Lic.No/Date:0510372635 05.12.2013 Defer Date:10.04.2014 227
Case No.:144/23/82ALC4/2013
Party Name:IPCA LABORATORIES LIMITED 06.03.2014 Status:Case Approved HQ File :01/82/050/01191/AM14/ RLA File :03/94/040/00763/AM14/ Lic.No/Date:0310760708 05.12.2013 Defer Date: Decision : In the light of earlier decision taken in mee韣�ng no. 18/82 dated 19.12.2013, it was decided to ra韣�fy 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
Allopurinol 1 kg 1. 3‐Amino Pyrazole Carboxamide Hemisulphate 1.5382 2. Formamide 1.50 228
Case No.:72/23/82ALC4/2013
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 06.03.2014 Status:Case Approved HQ File :01/82/050/01119/AM14/ RLA File :07/24/040/00273/AM14/ Lic.No/Date:0710100271 05.12.2013 Defer Date: Decision :. Committee considered case as per agenda and in light of earlier decision taken in meeting no. 14/82 dated 24.10.2013 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Export Qty. Sl.No. Import items Qty. allowed Cefuroxime 750 mg Inj. USP Vial size 10 ml each vial contains cefuroxime sodium USP equivalent to Cefuroxime 750 mg 1 vial 1. Cefuroxime Sodium Sterile USP 820.0 mg/vial RA may take appropriate action as per the decision of Norms Committee. 229
Case No.:62/23/82ALC4/2013
Party Name:LAKE CHEMICALS PRIVATE LIMITED Meet No/Date:23/82ALC4/2013 06.03.2014 Status:Case Deferred HQ File :01/82/050/01109/AM14/ RLA File :07/24/040/00238/AM14/ Lic.No/Date:0710100274 05.12.2013 Defer Date:10.04.2014 230
Case No.:18/23/82ALC4/2013
Party Name:NAPROD LIFE SCIENCES PVT. LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01065/AM14/ RLA File :03/95/040/00712/AM14/ Lic.No/Date:0310760768 05.12.2013 Defer Date:10.04.2014 231
Case No.:17/23/82ALC4/2013
Party Name:YASHO INDUSTRIES PVT.LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01064/AM14/ RLA File :03/95/040/00705/AM14/ Lic.No/Date:0310760774 Defer
05.12.2013 Date:10.04.2014 232
Case No.:146/23/82ALC4/2013
Party Name:CHIRAG ENTERPRISE 06.03.2014 Status:Case Deferred HQ File :01/82/050/01193/AM14/ RLA File :24/24/040/00022/AM14/ Lic.No/Date:2410040396 06.12.2013 Defer Date:10.04.2014 Decision :It was decided to defer the case for 10.04.2014 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals 233
Case No.:145/23/82ALC4/2013
Party Name:AVA CHEMICALS PVT.LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/01192/AM14/ RLA File :03/94/040/00741/AM14/ Lic.No/Date:0310761092 09.12.2013 Defer Date:10.04.2014 234
Case No.:96/23/82ALC4/2013
Party Name:MOREPEN LABORATORIES LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/01143/AM14/ RLA File :05/24/040/00313/AM14/ Lic.No/Date:0510372885 09.12.2013 Defer Date:10.04.2014 235
Case No.:118/23/82ALC4/2013
Party Name:RANBAXY LABORATORIES LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/01165/AM14/ RLA File :05/24/040/00312/AM14/ Lic.No/Date:0510372882 09.12.2013 Defer Date:10.04.2014 236
Case No.:11/23/82ALC4/2013
Party Name:SCITECH SPECIALITIES PVT. LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01058/AM14/ RLA File :03/95/040/00603/AM14/ Lic.No/Date:0310761103 09.12.2013 Defer Date:10.04.2014 237
Case No.:10/23/82ALC4/2013
Party Name:YASHO INDUSTRIES PVT.LTD. 06.03.2014 Status:Case Deferred
HQ File :01/82/050/01057/AM14/ RLA File :03/95/040/00720/AM14/ Lic.No/Date:0310761106 09.12.2013 Defer Date:10.03.2014 238
Case No.:63/23/82ALC4/2013
Party Name:AMI ORGANICS PVT LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01110/AM14/ RLA File :52/24/040/00037/AM14/ Lic.No/Date:5210040485 10.12.2013 Defer Date:10.04.2014 239
Case No.:143/23/82ALC4/2013
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 06.03.2014 Status:Case Deferred HQ File :01/82/050/01190/AM14/ RLA File :03/94/040/00776/AM14/ Lic.No/Date:0310761498 11.12.2013 Defer Date:10.04.2014 240
Case No.:95/23/82ALC4/2013
Party Name:JAGSONPAL PHARMACEUTICALS LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01142/AM14/ RLA File :05/23/040/00368/AM14/ Lic.No/Date:0510373220 11.12.2013 Defer Date:10.04.2014 241
Case No.:97/23/82ALC4/2013
Party Name:RANBAXY LABORATORIES LTD 06.03.2014 Status:Case Approved HQ File :01/82/050/01144/AM14/ RLA File :05/24/040/00257/AM14/ Lic.No/Date:0510373261 11.12.2013 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting no. 1/82 dated 04.04.2013 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed Candesartan Cilexetil 1 kg 1. 1chloroethyl chloroformate 0.45 kg 2. 4(Bromomethyl)2 cyanobiphenyl 1.66 kg 3. Acetone 3.45 kg 4. Acetonitrile 2.50 kg 5. Activated Carbon 0.100 kg 6. Cyclohexane 5.88 kg
Dimethyl formamide 1.52 kg 8. Ethyl acetate 10.00 9. Formic Acid 1.30 kg 10. Iso Propyl Alcohol 0.50 kg 11. Methanol 10.00 kg 12. Methylene Chloride 5.00 kg 13. Tertiary butanol 2.00 kg 14. Tetra ethyl ortho carbonate 1.19 kg 15 Tetra butyl ammonium bromide (TBAB) 0.18 kg 16. Toluene 5.00 kg 17 Triethylamine 0.31 kg 242
Case No.:8/23/82ALC4/2013
Party Name:SIRMAXO CHEMICALS PVT LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/01055/AM14/ RLA File :03/95/040/00725/AM14/ Lic.No/Date:0310761482 11.12.2013 Defer Date:10.04.2014 243
Case No.:82/23/82ALC4/2013
Party Name:DEEPAK NITRITE LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/01129/AM14/ RLA File :34/24/040/00212/AM14/ Lic.No/Date:3410038711 12.12.2013 Defer Date:10.04.2014 244
Case No.:9/23/82ALC4/2013
Party Name:NAWAL PRAKASH AVIKEM PVT.LTD., Meet No/Date:23/82ALC4/2013 06.03.2014 Status:Case Deferred HQ File :01/82/050/01056/AM14/ RLA File :03/95/040/00434/AM14/ Lic.No/Date:0310761637 12.12.2013 Defer Date:10.04.2014 245
Case No.:115/23/82ALC4/2013
Party Name:ALCHEM INTERNATIONAL LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01162/AM14/ RLA File :05/23/040/00365/AM14/ Lic.No/Date:0510373480 13.12.2013 Defer Date:10.04.2014
246
Case No.:83/23/82ALC4/2013
Party Name:SHIVA PHARMACHEM LTD, 06.03.2014 Status:Case Deferred HQ File :01/82/050/01130/AM14/ RLA File :34/24/040/00231/AM14/ Lic.No/Date:3410038734 16.12.2013 Defer Date:10.04.2014 247
Case No.:14/23/82ALC4/2013
Party Name:TITAN LABORATORIES PVT. LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01061/AM14/ RLA File :03/95/040/00753/AM14/ Lic.No/Date:0310761930 16.12.2013 Defer Date:10.04.2014 248
Case No.:126/23/82ALC4/2013
Party Name:TRIGON CHEMICALS PVT. LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01173/AM14/ RLA File :31/83/040/00134/AM14/ Lic.No/Date:3110061568 16.12.2013 Defer Date:10.04.2014 249
Case No.:127/23/82ALC4/2013
Party Name:TRIGON CHEMICALS PVT. LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01174/AM14/ RLA File :31/83/040/00133/AM14/ Lic.No/Date:3110061567 16.12.2013 Defer Date:10.04.2014 250
Case No.:128/23/82ALC4/2013
Party Name:TRIGON CHEMICALS PVT. LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01175/AM14/ RLA File :31/83/040/00132/AM14/ Lic.No/Date:3110061569 16.12.2013 Defer Date:10.04.2014 251
Case No.:88/23/82ALC4/2013
Party Name:DHANUKA LABORATORIES LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01135/AM14/ RLA File :05/23/040/00375/AM14/ Lic.No/Date:0510373696 17.12.2013 Defer Date:10.04.2014
252
Case No.:39/23/82ALC4/2013
Party Name:AARTI INDUSTRIES LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/01086/AM14/ RLA File :03/94/040/00760/AM14/ Lic.No/Date:0310762301 18.12.2013 Defer Date:10.04.2014 253
Case No.:50/23/82ALC4/2013
Party Name:AARTI INDUSTRIES LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/01097/AM14/ RLA File :03/94/040/00761/AM14/ Lic.No/Date:0310762302 18.12.2013 Defer Date:10.04.2014 254
Case No.:51/23/82ALC4/2013
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 06.03.2014 Status:Case Deferred HQ File :01/82/050/01098/AM14/ RLA File :03/94/040/00715/AM14/ Lic.No/Date:0310762311 18.12.2013 Defer Date:10.04.2014 Decision : It was decided to defer the case for 10.04.2014 for comments of Department of C&PC. 255
Case No.:86/23/82ALC4/2013
Party Name:INDO PHYTO CHEMICALS PVT LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/01133/AM14/ RLA File :05/23/040/00384/AM14/ Lic.No/Date:0510373927 18.12.2013 Defer Date:10.04.2014 Decision : It was decided to defer the case for 10.04.2014 for comments of Department of Pharmaceuticals. 256
Case No.:87/23/82ALC4/2013
Party Name:INDO PHYTO CHEMICALS PVT LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/01134/AM14/ RLA File :05/23/040/00385/AM14/ Lic.No/Date:0510373925 18.12.2013 Defer Date:10.04.2014 Decision : It was decided to defer the case for 10.04.2014 for comments of Department of Pharmaceuticals. 257
Case No.:37/23/82ALC4/2013
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/01084/AM14/ RLA File :03/95/040/01042/AM13/ Lic.No/Date:0310762360 Defer
18.12.2013 Date:10.04.2014 258
Case No.:36/23/82ALC4/2013
Party Name:ORION CHEM PVT.LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01083/AM14/ RLA File :03/95/040/00729/AM14/ Lic.No/Date:0310762471 18.12.2013 Defer Date:10.04.2014 259
Case No.:124/23/82ALC4/2013
Party Name:BALAJI AMINES LIMITED 06.03.2014 Status:Case Approved HQ File :01/82/050/01171/AM14/ RLA File :31/83/040/00156/AM14/ Lic.No/Date:3110061589 19.12.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/122/2011‐Ch II dated 08.01.2014, it was decided to ra韣�fy 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 MORPHOLINE 1 kg 1. DIETHYLENE GLYCOL 1.354 kg 2. AMMONIA ANHYDROUS 0.217 kg 3. HYDROGEN 0.200 kg 4. MORPHOLINE CATALYST 0.008 kg 260
Case No.:125/23/82ALC4/2013
Party Name:EMCURE PHARMACEUTICALS LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01172/AM14/ RLA File :31/83/040/00170/AM14/ Lic.No/Date:3110061658 19.12.2013 Defer Date:10.04.2014 261
Case No.:38/23/82ALC4/2013
Party Name:METROPOLITAN EXIMCHEM LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01085/AM14/ RLA File :03/95/040/00736/AM14/ Lic.No/Date:0310762602 19.12.2013 Defer Date:10.04.2014
Decision : It was decided to defer the case for 10.04.2014 for comments of Department of C&PC. 262
Case No.:89/23/82ALC4/2013
Party Name:RENOWN PHARMACEUTICALS PVT LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/01136/AM14/ RLA File :34/24/040/00225/AM14/ Lic.No/Date:3410038760 19.12.2013 Defer Date:10.04.2014 Decision : It was decided to defer the case for 10.04.2014 for comments of Department of Pharmaceuticals. 263
Case No.:84/23/82ALC4/2013
Party Name:TRANSPEK INDUSTRY LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/01131/AM14/ RLA File :34/24/040/00236/AM14/ Lic.No/Date:3410038767 19.12.2013 Defer Date:10.04.2014 Decision : It was decided to defer the case for 10.04.2014 for comments of Department of C&PC. 264
Case No.:40/23/82ALC4/2013
Party Name:AARTI INDUSTRIES LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/01087/AM14/ RLA File :03/94/040/00745/AM14/ Lic.No/Date:0310762897 20.12.2013 Defer Date:10.04.2014 265
Case No.:91/23/82ALC4/2013
Party Name:INTAS PHARMACEUTICALS LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/01138/AM14/ RLA File :08/24/040/00408/AM14/ Lic.No/Date:0810127281 20.12.2013 Defer Date:10.04.2014 266
Case No.:85/23/82ALC4/2013
Party Name:PARENTERAL DRUGS (INDIA) LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/01132/AM14/ RLA File :56/24/040/00033/AM14/ Lic.No/Date:5610003400 20.12.2013 Defer Date:10.04.2014 267
Case No.:29/23/82ALC4/2013
Party Name:AVA CHEMICALS PVT.LTD., 06.03.2014 Status:Case Approved HQ File :01/82/050/01076/AM14/ RLA File :03/94/040/00786/AM14/ Lic.No/Date:0310763107 Defer Date:
23.12.2013 Decision : In the light of wri埜�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/175/2011‐Ch II dated 29.10.2013, it was decided to ra韣�fy 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 EDTA FERRIC SODIUM Fe content 13% (+/ 0.5) 1 kg 1. ETHYLENE DIAMINE TETRA ACETIC ACID 0.0730 kg 268
Case No.:123/23/82ALC4/2013
Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/01170/AM14/ RLA File :31/83/040/00164/AM14/ Lic.No/Date:3110061675 23.12.2013 Defer Date:10.04.2014 269
Case No.:92/23/82ALC4/2013
Party Name:ESTEEM INDUSTRIES PVT. LTD, 06.03.2014 Status:Case Deferred HQ File :01/82/050/01139/AM14/ RLA File :17/24/040/00099/AM14/ Lic.No/Date:1710005619 23.12.2013 Defer Date:10.04.2014 270
Case No.:44/23/82ALC4/2013
Party Name:ALKYL AMINES CHEMICALS LTD 06.03.2014 Status:Case Approved HQ File :01/82/050/01091/AM14/ RLA File :03/94/040/00609/AM14/ Lic.No/Date:0310763298 24.12.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/85/2012‐Ch II dated 12.11.2013, it was decided to ra韣�fy 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 Acetonitrile 1 kg 1. Ace韣�c Acid 1.46 kg
271
Case No.:30/23/82ALC4/2013
Party Name:AVA CHEMICALS PVT.LTD., 06.03.2014 Status:Case Approved HQ File :01/82/050/01077/AM14/ RLA File :03/94/040/00814/AM14/ Lic.No/Date:0310763215 24.12.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/175/2011‐Ch II dated 29.10.2013, it was decided to ra韣�fy 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 EDTA TETRA AMMONIUM LIQUID ASSAY Min. 40% 1 kg 1. ETHYLENE DIAMINE TETRA ACETIC ACID (EDTA) 0.341 kg 272
Case No.:90/23/82ALC4/2013
Party Name:CADILA PHARMACEUTICALS LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01137/AM14/ RLA File :08/24/040/00403/AM14/ Lic.No/Date:0810127360 24.12.2013 Defer Date:10.04.2014 273
Case No.:41/23/82ALC4/2013
Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/01088/AM14/ RLA File :03/94/040/00749/AM14/ Lic.No/Date:0310763218 24.12.2013 Defer Date:10.04.2014 274
Case No.:54/23/82ALC4/2013
Party Name:O C SPECIALITIES PVT.LTD. 06.03.2014 Status:Case Approved HQ File :01/82/050/01101/AM14/ RLA File :03/95/040/00768/AM14/ Lic.No/Date:0310763290 24.12.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/108/2012‐Ch II dated 09.01.2014, it was decided to ra韣�fy 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 2,6‐Dichloro Benzoyl Chloride 1 kg 1. 2, 6 Dichloro Benzaldehyde 0.948 kg
275
Case No.:27/23/82ALC4/2013
Party Name:SANDOZ PRIVATE LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/01074/AM14/ RLA File :03/95/040/00758/AM14/ Lic.No/Date:0310763292 24.12.2013 Defer Date:10.04.2014 276
Case No.:52/23/82ALC4/2013
Party Name:ALKYL AMINES CHEMICALS LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/01099/AM14/ RLA File :03/94/040/00740/AM14/ Lic.No/Date:0310763366 26.12.2013 Defer Date:10.04.2014 277
Case No.:46/23/82ALC4/2013
Party Name:GUJARAT ORGANICS LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/01093/AM14/ RLA File :03/94/040/00820/AM14/ Lic.No/Date:0310763352 26.12.2013 Defer Date:10.04.2014 278
Case No.:49/23/82ALC4/2013
Party Name:INDO AMINES LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/01096/AM14/ RLA File :03/94/040/00804/AM14/ Lic.No/Date:0310763384 26.12.2013 Defer Date:10.04.2014 279
Case No.:65/23/82ALC4/2013
Party Name:RANBAXY LABORATORIES LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/01112/AM14/ RLA File :05/24/040/00258/AM14/ Lic.No/Date:0510374575 27.12.2013 Defer Date:10.04.2014 280
Case No.:71/23/82ALC4/2013
Party Name:RANBAXY LABORATORIES LTD Status:Case
06.03.2014 Deferred HQ File :01/82/050/01118/AM14/ RLA File :05/24/040/00317/AM14/ Lic.No/Date:0510374576 27.12.2013 Defer Date:10.04.2014 281
Case No.:64/23/82ALC4/2013
Party Name:S.M. HERBALS PVT.LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01111/AM14/ RLA File :05/24/040/00321/AM14/ Lic.No/Date:0510374573 27.12.2013 Defer Date:10.04.2014 Decision : It was decided to remind the firm to furnish the following technical details: • COA from foreign supplier for relevant import consignment for the imported input. • COA from Independent and approved Testing Laboratory for export product. • Stepwise process with wastage envisaged in the process. The case was deferred for 10.04.2014. 282
Case No.:43/23/82ALC4/2013
Party Name:ANUH PHARMA LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01090/AM14/ RLA File :03/94/040/00770/AM14/ Lic.No/Date:0310763631 30.12.2013 Defer Date:10.04.2014 283
Case No.:48/23/82ALC4/2013
Party Name:EXCEL INDUSTRIES LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/01095/AM14/ RLA File :03/94/040/00719/AM14/ Lic.No/Date:0310763628 30.12.2013 Defer Date:10.04.2014 284
Case No.:45/23/82ALC4/2013
Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. 06.03.2014 Status:Case Approved HQ File :01/82/050/01092/AM14/ RLA File :03/94/040/00831/AM14/ Lic.No/Date:0310763640 30.12.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/100/2012‐Ch II dated 12.11.2013, it was decided to ra韣�fy 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 DIPHENYL OCTYL PHOSPHITE 1 kg 1. YELLOW PHOSPHORUS 0.096 kg 2. PHENOL 0.603 kg 3. 2ETHYL HEXYL ALCOHOL / 2 0.418 kg
ETHYL HEXANOL 285
Case No.:93/23/82ALC4/2013
Party Name:PARAGON INDUSTRIES 06.03.2014 Status:Case Deferred HQ File :01/82/050/01140/AM14/ RLA File :08/24/040/00430/AM14/ Lic.No/Date:0810127594 31.12.2013 Defer Date:10.04.2014 286
Case No.:55/23/82ALC4/2013
Party Name:SATYAJIT CHEMICALS PVT.LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/01102/AM14/ RLA File :03/95/040/00791/AM14/ Lic.No/Date:0310763764 31.12.2013 Defer Date:10.04.2014 287
Case No.:53/23/82ALC4/2013
Party Name:EXCEL INDUSTRIES LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/01100/AM14/ RLA File :03/94/040/00744/AM14/ Lic.No/Date:0310764365 02.01.2014 Defer Date:10.04.2014 288
Case No.:28/23/82ALC4/2013
Party Name:GLENMARK GENERICS LIMITED 06.03.2014 Status:Case Approved HQ File :01/82/050/01075/AM14/ RLA File :03/94/040/00851/AM14/ Lic.No/Date:0310764371 02.01.2014 Defer Date: Decision :In the light of earlier decision taken in mee韣�ng No.4/82 dated 16.05.2013, it was decided to ra韣�fy 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 CILOSTAZOL 1 kg 1. 5(4Chlorobutyl)1cyclohexyl 1HTetrazole 0.88 2. 6Hydroxy3,4Dihydro1H Quinolin2One 0.59
289
Case No.:69/23/82ALC4/2013
Party Name:ASCENT FINECHEM PVT. LTD., 06.03.2014 Status:Case Approved HQ File :01/82/050/01116/AM14/ RLA File :08/24/040/00415/AM14/ Lic.No/Date:0810127686 03.01.2014 Defer Date: Decision : In the light of wri埜�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/1/2012‐Ch II dated 01.04.2013, it was decided to ra韣�fy 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 RASPBERRY KETONE / 4 (4 HYDROXYPHYENYL) BUTANE 2 ONE WHITE CRYSTALLINE POWDER PACKED IN G2PAC ASSEMBLY 700 LITER / 250 KGS 35 INCH x 35 INCH x 35 INCH POLYPRPELENE WOVEN FABRIC BAGS 110 NOS. 1 kg 1. pHYDROXY BENZALDEHYDE LIGHT YELLOW CRYSTALLINE POWDER 1.69 kg 2. ACETONE COLORLESS LIQUID 0.802 kg 3. G2PAC ASSEMBLY 700 LITTER / 250 KGS 35 INCH x 35 INCH x 35 INCH POLYPROPYLENE WOVEN FABRIC BAGS 700 LITTER / 250 KGS 35 INCH x 35 INCH x 35 INCH POLYPROPYLENE WOVEN FABRIC BAGS ( THIS LICENCE IS ISSUED AS PER PARA 4.7 OF H.B AM200914 WITH SUBJECT TO FIXATION OF NORMS BY N.C.DELHI.) Relevant as per packing policy 290
Case No.:68/23/82ALC4/2013
Party Name:H.J.AROCHEM PVT. LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/01115/AM14/ RLA File :08/24/040/00418/AM14/ Lic.No/Date:0810127690 03.01.2014 Defer Date:10.04.2014 291
Case No.:34/23/82ALC4/2013
Party Name:MACLEODS PHARMACEUTICALS LTD. 06.03.2014 Status:Case Approved HQ File :01/82/050/01081/AM14/ RLA File :03/95/040/00793/AM14/ Lic.No/Date:0310764442 03.01.2014 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/777/2013PI(Norms) dated 04.03.2014, 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:
y p p g pp y , Export product Exp. Qty. Sl. No. Import items Qty. allowed kg/kg LEVOFLOXACIN 500MG TABLETS Kg 1. (S) 9,10DIFLUORO3 METHYL7OXO 2,3DIHYDRO7H PYRIDO(1,2,3DE)1,4 BENZOXAZINE6 CARBOXYLIC ACID ETHYL ESTER 492.8 mg/ 500 mg Tablets 292
Case No.:20/23/82ALC4/2013
Party Name:ALTA LABORATORIES LTD. 06.03.2014 Status:Case Approved HQ File :01/82/050/01067/AM14/ RLA File :03/94/040/00842/AM14/ Lic.No/Date:0310765129 08.01.2014 Defer Date: Decision : In the light of earlier decision taken in mee韣�ng no. 31/82 dated 21.02.2013, it was decided to ra韣�fy 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 item Qty. allowed Sodium Salicylate 1 Kg. 1. Salicylic Acid 0.80 kg 293
Case No.:56/23/82ALC4/2013
Party Name:AVA CHEMICALS PVT.LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/01103/AM14/ RLA File :03/94/040/00822/AM14/ Lic.No/Date:0310765132 08.01.2014 Defer Date:10.04.2014 294
Case No.:35/23/82ALC4/2013
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 06.03.2014 Status:Case Deferred HQ File :01/82/050/01082/AM14/ RLA File :03/94/040/00871/AM14/ Lic.No/Date:0310765141 08.01.2014 Defer Date:10.04.2014
295
Case No.:42/23/82ALC4/2013
Party Name:ARIHANTANAM LIFECARE PVT. LTD. Meet No/Date:23/82ALC4/2013 06.03.2014 Status:Case Deferred HQ File :01/82/050/01089/AM14/ RLA File :03/94/040/00881/AM14/ Lic.No/Date:0310765339 09.01.2014 Defer Date:10.04.2014 296
Case No.:21/23/82ALC4/2013
Party Name:UNITED PHOSPHORUS LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01068/AM14/ RLA File :03/95/040/00590/AM14/ Lic.No/Date:0310765258 09.01.2014 Defer Date:10.04.2014 297
Case No.:23/23/82ALC4/2013
Party Name:BLISS GVS PHARMA LTD. 06.03.2014 Status:Case Approved HQ File :01/82/050/01070/AM14/ RLA File :03/94/040/00892/AM14/ Lic.No/Date:0310766067 13.01.2014 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/659/2013PI(Norms) dated 22.01.2014, 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 Exp. Qty. Sl. No. Import items Qty. allowed kg/kg RECTICIN100 SUPPOSITORY NET CONTENT OF IMPORT ITEM USEDINDOMETHACIN Kg 1. INDOMETHACIN BP 102 mg/ 100 mg Suppository 298
Case No.:19/23/82ALC4/2013
Party Name:DANOPHARM CHEMICALS PRIVATE LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01066/AM14/ RLA File :03/94/040/00772/AM14/ Lic.No/Date:0310766076 13.01.2014 Defer Date:10.04.2014 299
Case No.:32/23/82ALC4/2013
Party Name:STERLING AUXILIARIES PVT LTD 06.03.2014 Status:Case Deferred
HQ File :01/82/050/01079/AM14/ RLA File :03/95/040/00769/AM14/ Lic.No/Date:0310766054 13.01.2014 Defer Date:10.04.2014 300
Case No.:25/23/82ALC4/2013
Party Name:GLENMARK GENERICS LIMITED 06.03.2014 Status:Case Deferred HQ File :01/82/050/01072/AM14/ RLA File :03/94/040/00885/AM14/ Lic.No/Date:0310766291 15.01.2014 Defer Date:10.04.2014 301
Case No.:22/23/82ALC4/2013
Party Name:NEW ALLIANCE DYECHEM PVT. LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/01069/AM14/ RLA File :03/95/040/00802/AM14/ Lic.No/Date:0310766188 15.01.2014 Defer Date:10.04.2014 302
Case No.:33/23/82ALC4/2013
Party Name:NEW ALLIANCE DYECHEM PVT. LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/01080/AM14/ RLA File :03/95/040/00804/AM14/ Lic.No/Date:0310766192 15.01.2014 Defer Date:10.04.2014 303
Case No.:26/23/82ALC4/2013
Party Name:RIOCARE INDIA PRIVATE LIMITED. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01073/AM14/ RLA File :03/95/040/00822/AM14/ Lic.No/Date:0310766258 15.01.2014 Defer Date:10.04.2014 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/635/2013PI(Norms) dated 04.03.2014, it was decided to call from the firm the following technical details: i) Export Items 1 and 3 are API`s (100%) and should not fall under chapter 30. The firm should be advised to give correct and relevant HS code ii) whether any chemical reaction is involved in the manufacture of Dimethicone. If so, complete details of reaction, Mol. weight and % yield on molar basis may be furnished. iii) Past production visavis actual consumption of inputs duly certified by Central Excise Authorities be furnished for last 3 years. The case was deferred for 10.04.2014.
304
Case No.:16/23/82ALC4/2013
Party Name:NEW ALLIANCE DYECHEM PVT. LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/01063/AM14/ RLA File :03/95/040/00801/AM14/ Lic.No/Date:0310766418 16.01.2014 Defer Date:10.04.2014 305
Case No.:31/23/82ALC4/2013
Party Name:NEW ALLIANCE DYECHEM PVT. LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/01078/AM14/ RLA File :03/95/040/00803/AM14/ Lic.No/Date:0310766423 16.01.2014 Defer Date:10.04.2014 306
Case No.:24/23/82ALC4/2013
Party Name:BLUE CIRCLE ORGANICS PVT. LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01071/AM14/ RLA File :03/94/040/00829/AM14/ Lic.No/Date:0310766713 17.01.2014 Defer Date:10.04.2014 307
Case No.:2/21/82ALC4/2013
Party Name:HONEST BIOVET PVT. LTD 06.03.2014 Status:Case Deferred HQ File :01/82/050/01032/AM14/ RLA File :08/24/040/00456/AM14/ Lic.No/Date:0810128144 20.01.2014 Defer Date:10.04.2014 308
Case No.:12/21/82ALC4/2013
Party Name:KUDOS CHEMIE LTD., 06.03.2014 Status:Case Deferred HQ File :01/82/050/01042/AM14/ RLA File :22/21/040/00096/AM14/ Lic.No/Date:2210014544 23.01.2014 Defer Date:10.04.2014 309
Case No.:60/23/82ALC4/2013
Party Name:ALKYL AMINES CHEMICALS LTD 06.03.2014 Status:Case Approved HQ File :01/82/050/01107/AM14/ RLA File :03/94/040/00497/AM14/ Lic.No/Date:0310770983 19.02.2014 Defer Date: Decision : In the light of wri埜�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/85/2012‐Ch II dated 12.11.2013, it
was decided to ra韣�fy 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 Acetonitrile 1 kg 1. Ace韣�c Acid 1.46 kg 310
Case No.:47/23/82ALC4/2013
Party Name:PORUS LABORATORIES PVT LTD. 06.03.2014 Status:Case Deferred HQ File :01/82/050/01094/AM14/ RLA File :09/24/040/00585/AM14/ Lic.No/Date:0910059356 19.02.2014 Defer Date:10.04.2014 311
Case No.:57/23/82ALC4/2013
Party Name:CADILA HEALTHCARE LTD., 06.03.2014 Status:Case Approved HQ File :01/82/050/01104/AM14/ RLA File :08/24/040/00506/AM14/ Lic.No/Date:0810129079 21.02.2014 Defer Date: Decision :In the light of earlier decision taken in mee韣�ng no. 2/82 dated 18.04.2013, it was decided to ra韣�fy 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 Metformin HCL 500 mg tabs. 1000 tablets 1. Metformin HCL USP. 0.5100 kg 2. Microcrystalline Cellulose, NF (Avicel PH 101) 0.0225 kg 3. Povidone K 30 0.0200 kg 4. Microcrystalline Cellulose (Avicel PH 102) 0.0200 kg 5. Magnesium Stearate 0.0015 kg 6. Hypermellose 6 CPS 2910 0.0045 kg 716. Bottles & Caps (packing material in finished form) As per packing policy. Metformin HCL 850 mg Tabs 1000 Tablets 1. Meformin HCL USP 0.8670 kg 2. Microcrystalline cellulose, NF (Avicel PH 101) 0.03825 kg 3. Povidone K 30 0.0340 kg 4. Micrystalline cellulose (Avicel PH 102) 0.0340 kg 5. Magnesium Stearate 0.00255 kg 6. Hypermellose 6 CPS 2910 0.00765 kg
716. Bottles & Caps (packing material in finished form) As per packing policy Metformin HCL 1000 mg tablets 1000 tablets 1 Meformin HCL USP 1.0200 kg 2 Microcrystalline cellulose, NF (Avicel PH 101) 0.0450 kg 3 Povidone K 30 0.0400 kg 4 Micrystalline cellulose (Avicel PH 102) 0.0400 kg 5 Magnesium Stearate 0.0030 kg 6 Hypermellose 6 CPS 2910 0.0090 kg 716 Bottles & Caps (packing material in finished form) As per packing policy RA may take appropriate action as per the packing policy. 312
Case No.:58/23/82ALC4/2013
Party Name:CADILA HEALTHCARE LTD., 06.03.2014 Status:Case Approved HQ File :01/82/050/01105/AM14/ RLA File :08/24/040/00513/AM14/ Lic.No/Date:0810129080 21.02.2014 Defer Date: Decision :In the light of earlier decision taken in mee韣�ng no. 12/82 dated 12.09.2013, it was decided to ra韣�fy 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 Benzonatate 100 mg Capsules 1 Million 1. Benzonanate USP 102 kg 2. Gela韣�n NF 168 kg 3. Glycerin USP 24 kg 4. Noncrystallizing Sorbitol Solu韣�on NF 72 kg 5. Triethyl Nitrate NF 75 kg 6. Bo埜�les and Caps (packing material in finished form a. 60 CC White HDPE Round Bo埜�le As per packing policy 7. 75 CC White HDPE Round Bo埜�le ‐do‐ 8. 33 MM White PP NCRC CAP ‐do‐ Benzonatate 200 mg Capsules 1 million 1. Benzonanate 204 kg 2. Gela韣�n NF 231 kg 3. Glycerin USP 33 kg 4. Noncrystallizing Sorbitol Solu韣�on NF 99 kg 5. Triethyl Nitrate NF 75 kg 6. 225 CC white HDPE CRC Bo埜�le As per packing policy 7. 45 MM white NCRC Cap ‐do‐
313
Case No.:59/23/82ALC4/2013
Party Name:CADILA HEALTHCARE LTD., 06.03.2014 Status:Case Approved HQ File :01/82/050/01106/AM14/ RLA File :08/24/040/00524/AM14/ Lic.No/Date:0810129093 24.02.2014 Defer Date: Decision : In the light of earlier decision taken in meeting no. 11/82 dated 05.09.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export Product Export Qty. Sl.No. Import items Quantity allowed TAMSULOSIN HCL 0.4 MG. CAPS (ACTIVE INGREDIENT : TAMSULOSIN HYDROCHLORIDE 101.60 KGS.) 1 No. 1. TAMSULOSIN HYDROCHLORIDE 0.408 mg 2. METHACRYLIC ACID COPOLYMER DISPERSION NF 170.012 mg 3. MICROCRYSTALLINE CELLULOSE (AVICEL PH 102) 233 mg 4. Import items at Sl. No.4 to 8 As per packing policy RA may take appropriate action as per the decision of Norms Committee. 314
Case No.:61/23/82ALC4/2013
Party Name:CADILA HEALTHCARE LTD., 06.03.2014 Status:Case Approved HQ File :01/82/050/01108/AM14/ RLA File :08/24/040/00530/AM14/ Lic.No/Date:0810129172 25.02.2014 Defer Date: Decision : In the light of earlier decision taken in meeting no. 15/82 dated 31.10.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export Product Export Qty. S.No Import Product Quantity Allowed kg/kg 2chloromethyl4Methyl Quinazoline(CD 605 BS) 1 kg 1. 2amino Acetophenone 1.04 2. Methyl Cyclohexane 1.954 RA may take appropriate action as per the decision of Norms Committee.
Date:18.03.2014 Place:New Delhi R.C.Meena Dy. Director General of Foreign Trade
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