DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi 0
Para 4.7 Decision(DRAFT)
MEETING NUMBER : 5/82ALC4/2014 MEETING DATE : 24.07.2014 Actually held on 22.08.2014 The Meeting No. 5/82 of 201415 to consider the cases/issues under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to Chemical and Allied products and falling under Chapter 29 and 30 was scheduled for 24.07.2014 but actually held on 22.08.2014 under the Chairmanship of Shri Jaikant Singh, Addl. DGFT in Room No.11, Udyog Bhawan, New Delhi. Following members were present: Shri D.N. Mathur. Consultant, Department of Pharmaceutical Shri O.P. Sharma, Joint, Industrial adviser, Department of C&PC Shri Nirmal Kumar, Deputy Director General of Foreign Trade Dr. Nitin Jain D/o Biotechnology The committee went through the minutes of earlier NC –III meeting No. 4/82 dated 03.07.2014 and approved the same. The following cases/issues were discussed and the committee took the decision as mentioned against the each case.
Case No. B39
M/s Rohan Exports India Ltd. & M/a Mahesh Raj Chemicals Ltd. . Meeting No.05/AM15 dated – 25.07.2014 F.No. 01/83/162/00654/AM12/DESIII Appeals filed Against order of the Jt. DGFT, Ahmedabad in pursuance of order dated 20.01.2010 of the Hon’ble High Court of Gujarat. Decision: Committee considered case as per agenda and in consultation with technical authority present in the meeting and it has been found that despite of repeated reminder the Institute of Chemical Technology Mumbai, has not been given their opinion whether the export product “4, 4 Diamino Sulfanilide “ is manufactured only of purity 93% on commercial scale. Further the product will always contained 7% or more of impurities. It was also decided to remind the Department of C&PC to take appropriate action and furnish their comments as the case is long pending. The case is defer red for 11.09.2014
Case No. B40
M/s Saurav Chemicals Ltd.
F.No. 01/82/050/00865/AM12/DESIII F.No. 01/82/050/01382/AM13/DESIII RLA’s File no. 22/24/040/00039/AM12 RLA’s File no. 22/24/040/00074/AM13 Adv. Lic. No. 2210011843 dt. 01.09.2011 Adv. Lic. No. 2210013689 dt. 05.03.2013 Decision: Copy of fresh representation, received from the firm, has been already sent to Department of Pharmaceuticals for their comments. The case was deferred for 11.09.2014.
Case No. B41
M/s Otsuka Chemical (India) Pvt Ltd. F.No. 01/82/050/00434/AM14/DESIII RA No. 05/24/040/00137/AM14 Adv. Lic. No. 0510360662 dt. 24.07.2013 Decision: Committee considered the case as per agenda and it was decided to call for technical literature in support of description of export product. The case is deferred for 11.09.2014.
Case No. B42
M/s Vindhya Pharma (India) Pvt Ltd. F.No. 01/82/050/00660/AM14/DESIII RLA’s File no. 09/24/040/122/AM12 Adv. Lic. No. 0910056447 dt. 25.06.2013 Decision: It was decided to defer the case for 11.09.2014 for comments of Department of Pharmaceuticals.
Case No. B43
M/s Padmini Aromatics Pvt. Ltd. F.No. 01/82/050/00375/AM10/DESIII F.No. 01/82/050/00375/AM10/DESIII RLA’s File no. 07/24/040/136/AM10 RLA’s File no. 07/24/040/294/AM10 Adv. Lic. No. 0710066165 dt. 24.07.2009 Adv. Lic. No. 0710068389 dt. 19.11.2009 Decision: It was decided to defer the case for 11.09.2014 for comments of Department of C&PC
Case No. B44
M/s Varun Medimpex Inc. F.No. 01/83/050/01147/AM13/DESIII RLA’s File no. 05/24/040/00405/AM13 Adv. Lic. No. 0510347194 dt. 22.02.2013 Decision: It was decided to discuss the case in next NC meeting with concerned technical authority. The case is deferred 11.09.2014.
Case No. B45
M/s Sequent Scientific Ltd. F.No. 01/83/050/01659/AM08/DESIII F.No. 01/83/050/00078/AM08/DESIII RLA’s File no. 03/95/040/00807/AM08 RLA’s File no. 03/95/040/00018/AM08 Adv. Lic. No. 0310451861 dt. 28.11.2007 Adv. Lic. No. 0310426069 dt. 10.04.2007 Decision: In the light of wri⯒en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/6/2014‐Ch II dated 23.07.2014, it was decided to ra㘐�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 2,3,4, TRIHYDROXY BANZALDEHYDE 1 kg 1 PYROGALLIC ACID 1.090 KG RA may take appropriate action as per the decision of Norms Committee.
Case No. B46
M/s Pharmazell (India) Pvt Ltd. F.No. 01/82/162/00419/AM14/DESIII Decision: It was decided to defer the case for 11.09.2014 for comments of Department of Pharmaceuticals.
Case No. B47
M/s Aarti Drugs Ltd. F.No. 01/82/050/427/AM13/DESIII RA. No. 03/81/040/241/AM13 RA No. 03/81/040/00072/AM14 Adv. Lic. No. 0310714511 dt. 07.11.2012 Adv. Lic. No. 0310737543 dt. 13.06.2013 Decision: It was decided to remind the firm to furnish relevant portion of British Pharmacopeia to show that 2 Thiophene Ethylamine and Thiophene2Ethanol are one and same. The case was deferred for 11.09.2014.
Case No. B48
M/s. Vivimed Labs. Ltd., File No. 01/82/162/00050/AM15/DESIII File No. 01/82/162/00053/AM15/DESIII Adv. Lic. No 0910052425 dated 30.04.2012 Adv. Lic. No 0910052164 dated 13.04.2012 RA.No.09/24/040/00044/AM13 RA.No.09/24/040/00016/AM13
Decision: It was decided to defer the case for 11.09.2014 for comments of Department of Chemicals and Petrochemicals.
Case No. B49
M/s. PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) F. No.01/82/50/00557/AM13/DES‐III adv. Lic. No. 0310701405 dated 10.07.2012 Decision: Commi⯒ee considered the case as per agenda and it has been observed that the Norms have been finalized on the basis of CA cer㘐�ficate furnish by the party. Now, they have requested for revision of the same. If wrong CA cer㘐�ficate was furnished why ac㘐�on should not be ini㘐�ated against the concerned CA and the party which had also accepted and forwarded the CA cer㘐�ficate.
Case No. B50
M/s. PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) F. No.01/82/50/00556/AM13/DESIII F. No.01/82/50/00001/AM13/DESIII F. No.01/82/50/01173/AM13/DESIII adv. Lic. No. 0310701402 dated 10.07.2012 adv. Lic. No. 0310688849 dated 30.03.2012 adv. Lic. No. 0310721416 dated 18.01.2013 Decision: Commi⯒ee considered the case as per agenda and it has been observed that the Norms have been finalized on the basis of CA cer㘐�ficate furnish by the party. Now, they have requested for revision of the same. If wrong CA cer㘐�ficate was furnished why ac㘐�on should not be ini㘐�ated against the concerned CA and the party which had also accepted and forwarded the CA cer㘐�ficate.
Case No. B51
M/s Chirag Enterprise, Jamnagar, Gujarat F.No. 01/82/050/00256/AM11/DESIII F.No. 01/82/050/01090/AM11/DESIII RLA’s File no. 24/24/040/00009/AM11 RLA’s File no. 24/24/040/00014/AM11 Adv. Lic. No. 2410029974 dt. 27.10.2010 Adv. Lic. No. 2410030871 dt. 27.10.2010 Decision: It was decided to defer the case for 11.09.2014 for comments of Petrochemical division of Department of C&PC
Case No. B‐52
M/s Haldia Petrochemicals Ltd. F.No. 01/82/050/01534/AM09/DES‐III Adv. Lic.No. 0210122139 dated 13.01.2009 RA F.No. 02/24/040/00248/AM09 Decision: It was decided to defer the case for 11.09.2014 for comments of Petrochemical division of Department of C&PC. 1
Case No.:28/28/82ALC4/2012
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:5/82ALC4/2014 24.07.2014 Status:Deffered and Reindexed HQ File :01/82/050/00995/AM13/ RLA File :09/24/040/00270/AM13/ Lic.No/Date:0910053660 04.09.2012 Defer Date:25.09.2014 Decision : It was decided to remind the firm to furnish the details of Past Production visa vis Actual consumption of inputs duly certified by Central Excise Authorities. The case was deferred for 25.09.2014. 2
Case No.:3/23/82ALC4/2012
Party Name:TITAN LABORATORIES PVT. LTD. Meet No/Date:5/82ALC4/2014 24.07.2014 Status:Case Rejected HQ File :01/82/050/00803/AM13/ RLA File :03/95/040/00544/AM13/ Lic.No/Date:0310713360 22.10.2012 Defer Date: Decision :withdrawn the case is already rejected by NC in its 4/82 meeting dated 03.07.2014 3
Case No.:15/33/82ALC4/2012
Party Name:INDSWIFT LABORATORIES LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/01162/AM13/ RLA File :22/24/040/00039/AM13/ Lic.No/Date:2210013390 09.11.2012 Defer Date:11.09.2014 Decision :It was decided to defer the case for 11.09.2014 for comments of Department of Pharmaceuticals. 4
Case No.:171/33/82ALC4/2012
Party Name:CADILA HEALTHCARE LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/01318/AM13/ RLA File :08/24/040/00256/AM13/ Lic.No/Date:0810117315 02.01.2013 Defer Date:11.09.2014 Decision :It was decided to remind the firm to furnish a copy of Master batch Formula duly certified by Quality Control Incharge. The case was deferred for 29.09.2014 5
Case No.:28/4/82ALC4/2013
24.07.2014 Status:Case Approved HQ File :01/82/050/00069/AM14/ RLA File :09/24/040/00520/AM13/ Lic.No/Date:0910054940 Defer Date:
05.02.2013 Decision :Withdrawn the case has been already approved by NC in its 3/82 meeting dated 08.05.2014. 6
Case No.:151/33/82ALC4/2012
Party Name:FORACE POLYMERS (P) LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/01298/AM13/ RLA File :05/23/040/00459/AM13/ Lic.No/Date:0510345208 07.02.2013 Defer Date:11.09.2014 Decision :It was decided to defer the case for 11.09.2014 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals. 7
Case No.:33/2/82ALC4/2013
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 24.07.2014 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:11.09.2014 8
Case No.:71/4/82ALC4/2013
Party Name:CHIRAG ENTERPRISE 24.07.2014 Status:Case Deferred HQ File :01/82/050/00112/AM14/ RLA File :24/24/040/00001/AM14/ Lic.No/Date:2410038645 09.04.2013 Defer Date:11.09.2014 Decision :It was decided to defer the case for 11.09.2014 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals 9
Case No.:3/3/82ALC4/2013
Party Name:LAKE CHEMICALS PRIVATE LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00036/AM14/ RLA File :07/24/040/00003/AM14/ Lic.No/Date:0710094921 18.04.2013 Defer Date:11.09.2014 10
Case No.:87/14/82ALC4/2013
Party Name:ASTRIX LABORATORIES LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00672/AM14/ RLA File :09/24/040/00009/AM14/ Lic.No/Date:0910055844 23.04.2013 Defer Date:25.09.2014 Decision :It was decided to defer the case for 29.09.2014 for comments of Department of Pharmaceuticals. 11
Case No.:170/10/82ALC4/2013
Party Name:AGOG PHARMA LTD. Status:Case
24.07.2014 Deferred HQ File :01/82/050/00353/AM14/ RLA File :03/94/040/00075/AM14/ Lic.No/Date:0310733767 09.05.2013 Defer Date:11.09.2014 12
Case No.:142/10/82ALC4/2013
Party Name:WOCKHARDT LIMITED 24.07.2014 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:25.09.2014 Decision :It was decided to remind DCGI to furnish their comments. The case was deferred for 29.09.2014. 13
Case No.:132/14/82ALC4/2013
Party Name:BLUE DIP ORGANIC INDUSTRIES, 24.07.2014 Status:Case Deferred HQ File :01/82/050/00717/AM14/ RLA File :03/94/040/00067/AM14/ Lic.No/Date:0310735418 23.05.2013 Defer Date:11.09.2014 Decision :It was decided to defer the case 11.09.2014 for comments of Department of Chemicals and Petrochemicals. 14
Case No.:42/20/82ALC4/2013
Party Name:GLAND PHARMA LIMITED 24.07.2014 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:25.09.2014 Decision :It was decided to defer the case for 29.09.2014 for comments of Department of Pharmaceuticals. 15
Case No.:44/15/82ALC4/2013
Party Name:IPCA LABORATORIES LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00806/AM14/ RLA File :03/94/040/00103/AM14/ Lic.No/Date:0310735991 29.05.2013 Defer Date:11.09.2014 16
Case No.:133/14/82ALC4/2013
Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00718/AM14/ RLA File :03/94/040/00537/AM13/ Lic.No/Date:0310736138 30.05.2013 Defer Date:25.09.2014 Decision :It was decided to defer the case for 29.09.2014 for comments of Department of Pharmaceuticals. 17
Case No.:156/14/82ALC4/2013
Party Name:EYTAN LABS LIMITED Status:Case
24.07.2014 Deferred HQ File :01/82/050/00741/AM14/ RLA File :09/24/040/00087/AM14/ Lic.No/Date:0910056288 07.06.2013 Defer Date:25.09.2014 Decision :It was decided to defer the case for 29.09.2014 for comments of Department of Pharmaceuticals. 18
Case No.:77/14/82ALC4/2013
Party Name:GLAND PHARMA LIMITED 24.07.2014 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:25.09.2014 Decision :It was decided to defer the case for 25.09.2014 for comments of Department of Pharmaceuticals. 19
Case No.:199/10/82ALC4/2013
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 24.07.2014 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:11.09.2014 20
Case No.:40/12/82ALC4/2013
Party Name:SMILAX LABORATORIES LIMITED Meet No/Date:5/82ALC4/2014 24.07.2014 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:11.09.2014 Decision :Reply received from the firm and sent to Department of Pharmaceuticals for their comments. The case was deferred for 11.09.2014. 21
Case No.:28/12/82ALC4/2013
Party Name:BLISS GVS PHARMA LTD. 24.07.2014 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:25.09.2014 Decision :it was decided to remind the firm to furnish 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 29.09.2014. 22
Case No.:183/10/82ALC4/2013
Party Name:VIVEK PHARMACHEM (INDIA) LTD., 24.07.2014 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:25.09.2014
Decision :It was decided to remind the firm to furnish a copy DML (Drug Manufacturing Licence) from the firm. The case was deferred for 29.09.2014 23
Case No.:22/12/82ALC4/2013
Party Name:INDOFIL INDUSTRIES LTD. 24.07.2014 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:11.09.2014 24
Case No.:111/10/82ALC4/2013
Party Name:STERICAT GUTSTRINGS PVT. LTD. Meet No/Date:5/82ALC4/2014 24.07.2014 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:11.09.2014 Decision :It was decided to defer the case for 11.09.2014 for comments of Department of IPP.. 25
Case No.:90/14/82ALC4/2013
24.07.2014 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:11.09.2014 26
Case No.:172/14/82ALC4/2013
Party Name:RECKON DIAGNOSTICS PVT. LTD. Meet No/Date:5/82ALC4/2014 24.07.2014 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:25.09.2014 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 29.09.2014. 27
Case No.:201/10/82ALC4/2013
Party Name:SHASUN PHARMACEUTICALS LIMITED 24.07.2014 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:25.09.2014 Decision :It was decided to remind the firm to furnish a copy of Master Batch Formula duly certified by Quality Control Incharge. The case was deferred for 29.09.2014.
28
Case No.:173/14/82ALC4/2013
Party Name:ALEMBIC PHARMACEUTICALS LTD 24.07.2014 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:11.09.2014 29
Case No.:24/12/82ALC4/2013
Party Name:WOCKHARDT LIMITED 24.07.2014 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:25.09.2014 Decision ::It was decided to remind DCGI to furnish their comments. The case was deferred for 29.09.2014. 30
Case No.:44/12/82ALC4/2013
Party Name:ENCUBE ETHICALS PVT LTD 24.07.2014 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:11.09.2014 31
Case No.:160/14/82ALC4/2013
Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 24.07.2014 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:11.09.2014 32
Case No.:60/14/82ALC4/2013
Party Name:GLAND PHARMA LIMITED 24.07.2014 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:25.09.2014 Decision :It was decided to defer the case for 29.09.2014 for comments of Department of Pharmaceuticals. 33
Case No.:28/14/82ALC4/2013
Party Name:STERICON PHARMA PVT.LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00613/AM14/ RLA File :07/24/040/00107/AM14/ Lic.No/Date:0710096793 17.07.2013 Defer Date:11.09.2014
34
Case No.:21/12/82ALC4/2013
Party Name:WOCKHARDT LIMITED 24.07.2014 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:25.09.2014 Decision ::It was decided to remind DCGI to furnish their comments. The case was deferred for 29.09.2014. 35
Case No.:68/17/82ALC4/2013
Party Name:BHARAT PARENTERALS LTD, 24.07.2014 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:25.09.2014 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 29.09.2014 36
Case No.:52/12/82ALC4/2013
Party Name:UNIJULES LIFE SCIENCES LTD. 24.07.2014 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:25.09.2014 Decision :It was decided to remind the firm to furnish the following technical details: 1. Technical details as per Appendix 33 for conversion of Gadolinium to Gadopenteate Dimeglumine. 2. Volume of the Injection /Vial to be exported. The case was deferred for 29.09.2014 37
Case No.:1/19/82ALC4/2013
Party Name:AUROBINDO PHARMA LIMITED 24.07.2014 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:11.09.2014 38
Case No.:46/14/82ALC4/2013
24.07.2014 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:11.09.2014 39
Case No.:24/17/82ALC4/2013
Party Name:SMILAX LABORATORIES LIMITED Meet No/Date:5/82ALC4/2014 Status:Case
24.07.2014 Deferred HQ File :01/82/050/00886/AM14/ RLA File :09/24/040/00180/AM14/ Lic.No/Date:0910056902 25.07.2013 Defer Date:11.09.2014 40
Case No.:23/14/82ALC4/2013
Party Name:RA CHEM PHARMA LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00608/AM14/ RLA File :09/24/040/00191/AM14/ Lic.No/Date:0910056934 29.07.2013 Defer Date:11.09.2014 41
Case No.:28/19/82ALC4/2013
Party Name:SMILAX LABORATORIES LIMITED Meet No/Date:5/82ALC4/2014 24.07.2014 Status:Case Deferred HQ File :01/82/050/00973/AM14/ RLA File :09/24/040/00181/AM14/ Lic.No/Date:0910056940 29.07.2013 Defer Date:11.09.2014 42
Case No.:43/12/82ALC4/2013
Party Name:AMI ORGANICS PVT LTD. 24.07.2014 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:11.09.2014 Decision :It was decided to defer the case for 11.09.2014 for comments of Department of C&PC. 43
Case No.:1/10/82ALC4/2013
Party Name:MICRO LABS LTD 24.07.2014 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:25.09.2014 Decision :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 29.09.2014. 44
Case No.:22/14/82ALC4/2013
Party Name:MSN LABORATORIES PRIVATE LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00607/AM14/ RLA File :09/24/040/00192/AM14/ Lic.No/Date:0910056971 31.07.2013 Defer Date:11.09.2014
45
Case No.:17/13/82ALC4/2013
Party Name:PAB ORGANICS PVT.LTD, 24.07.2014 Status:Case Deferred HQ File :01/82/050/00493/AM14/ RLA File :34/24/040/00085/AM14/ Lic.No/Date:3410037541 31.07.2013 Defer Date:25.09.2014 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 29.09.2014 46
Case No.:31/4/82ALC4/2014
Party Name:UNIVERSAL BIOFUELS PRIVATE LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00279/AM15/ RLA File :09/24/040/00155/AM14/ Lic.No/Date:0910056959 31.07.2013 Defer Date:25.09.2014 Decision :It was decided to defer the case for 29.09.2014 for comments of Department of C&PC. 47
Case No.:61/14/82ALC4/2013
Party Name:HETERO DRUGS LIMITED, 24.07.2014 Status:Case Deferred HQ File :01/82/050/00646/AM14/ RLA File :09/24/040/00206/AM14/ Lic.No/Date:0910057007 02.08.2013 Defer Date:11.09.2014 48
Case No.:48/14/82ALC4/2013
Party Name:LOUIS PHARMACEUTICALS PVT LTD 24.07.2014 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:25.09.2014 Decision :It was decided remind the firm to furnish the following information: (a) Complete technical details as per Appendix 33. (b) COA of imported R.M. from the Foreign Supplier. (c) COA of the export item. (d) Past production visàvis actual consumption of inputs duly certified by Central Excise Authority. The case was deferred for 29.09.2014 49
Case No.:148/14/82ALC4/2013
Party Name:SUVEN LIFE SCIENCES LIMITED 24.07.2014 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:11.09.2014
50
Case No.:42/14/82ALC4/2013
Party Name:AVA CHEMICALS PVT.LTD., 24.07.2014 Status:Case Rejected HQ File :01/82/050/00627/AM14/ RLA File :03/94/040/00220/AM14/ Lic.No/Date:0310744155 05.08.2013 Defer Date: Decision :withdrawn the case has been already rejected by the NC in its 4/82 meeting dated 03.07.2014 51
Case No.:5/4/82ALC4/2014
Party Name:SANMAR SPECIALITY CHEMICALS LIMITED, 24.07.2014 Status:Case Deferred HQ File :01/82/050/00253/AM15/ RLA File :04/24/040/00046/AM14/ Lic.No/Date:0410148580 05.08.2013 Defer Date:25.09.2014 Decision :It was decided to defer the case for 29.09.2014 for comments of Department of Chemicals and Petrochemicals. 52
Case No.:45/14/82ALC4/2013
Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 24.07.2014 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:25.09.2014 Decision :It was decided to remind the firm to furnish complete technical details as per Appendix 33. The case was deferred for 29.09.2014. 53
Case No.:40/14/82ALC4/2013
Party Name:CTX LIFESCIENCES PVT LTD, 24.07.2014 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:25.09.2014 Decision :It was decided to call from the firm following information: (a) Complete technical details as per Appendix 33. (b) Past production visàvis actual consumption of inputs duly certified by Central Excise Authority. The case was deferred for 29.09.2014 54
Case No.:165/14/82ALC4/2013
Party Name:MEDREICH LIMITED 24.07.2014 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:11.09.2014 Decision :It was decided to defer the case for 11.09.2014 for comments of Department of Pharmaceuticals 55
Case No.:22/13/82ALC4/2013
Party Name:PROMED EXPORTS PVT.LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00498/AM14/ RLA File :05/24/040/00171/AM14/ Lic.No/Date:0510362268 Defer
07.08.2013 Date:11.09.2014 Decision :It was decided to defer the case for 11.09.2014 for comments of Department of Pharmaceuticals 56
Case No.:20/14/82ALC4/2013
Party Name:SRIAM LABS PRIVATE LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00605/AM14/ RLA File :09/24/040/00177/AM14/ Lic.No/Date:0910057053 07.08.2013 Defer Date:11.09.2014 57
Case No.:11/13/82ALC4/2013
Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 24.07.2014 Status:Case Deferred HQ File :01/82/050/00487/AM14/ RLA File :03/95/040/00134/AM14/ Lic.No/Date:0310744468 07.08.2013 Defer Date:25.09.2014 Decision :It was decided to defer the case for 29.09.2014 for comments of Department of Pharmaceuticals 58
Case No.:34/13/82ALC4/2013
Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 24.07.2014 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:25.09.2014 Decision :It was decided to call from the firm complete technical details as per Appendix 33. The case was deferred for 29.09.2014. 59
Case No.:73/13/82ALC4/2013
Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 24.07.2014 Status:Case Deferred HQ File :01/82/050/00549/AM14/ RLA File :03/95/040/00133/AM14/ Lic.No/Date:0310744832 12.08.2013 Defer Date:25.09.2014 Decision :It was decided to call from the firm complete technical details as per Appendix 33. The case was deferred for 29.09.2014. 60
Case No.:76/13/82ALC4/2013
Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 24.07.2014 Status:Case Deferred HQ File :01/82/050/00552/AM14/ RLA File :03/95/040/00125/AM14/ Lic.No/Date:0310744834 12.08.2013 Defer Date:25.09.2014 Decision :it was decided to remind the firm to furnish the following information : i) Complete technical details as per Appendix 33 for the export product (ii) Past production visàvis actual consumption of input duly certified by Central Excise Authorities.
The case was deferred for 29.09.2014 61
Case No.:75/13/82ALC4/2013
Party Name:WOCKHARDT LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00551/AM14/ RLA File :03/95/040/00320/AM14/ Lic.No/Date:0310744861 12.08.2013 Defer Date:25.09.2014 Decision :It was decided to remind DCGI to furnish their comments. The case was deferred for 25.09.2014. 62
Case No.:107/13/82ALC4/2013
Party Name:DR REDDYS LABORATORIES LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00583/AM14/ RLA File :09/24/040/00222/AM14/ Lic.No/Date:0910057189 14.08.2013 Defer Date:25.09.2014 Decision :It was decided to remind the firm to furnish the following information : i) Complete details as per Appendix 33. ii) Copy relevant technical literature in support of yields envisaged iii) Past production visàvis actual consumption of input duly certified by Central Excise Authorities. The case was deferred for 25.09.2014 63
Case No.:147/14/82ALC4/2013
24.07.2014 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:11.09.2014 64
Case No.:122/14/82ALC4/2013
Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 24.07.2014 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:11.09.2014 Decision :It was decided to defer the case for 11.09.2014 for comments of Department of Pharmaceuticals 65
Case No.:66/14/82ALC4/2013
Party Name:SRINI PHARMACEUTICALS LTD., 24.07.2014 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:11.09.2014
66
Case No.:121/14/82ALC4/2013
Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 24.07.2014 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:11.09.2014 67
Case No.:34/14/82ALC4/2013
Party Name:SMILAX LABORATORIES LIMITED Meet No/Date:5/82ALC4/2014 24.07.2014 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:11.09.2014 68
Case No.:1/5/82ALC4/2014
Party Name:SPAK ORGOCHEM (INDIA) PVT. LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00318/AM15/ RLA File :03/95/040/00167/AM14/ Lic.No/Date:0310745808 19.08.2013 Defer Date:11.09.2014 Decision :It was decided to defer the case 11.09.2014 for comments of Department of Chemicals and Petrochemicals. 69
Case No.:2/5/82ALC4/2014
Party Name:SPAK ORGOCHEM (INDIA) PVT. LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00319/AM15/ RLA File :03/95/040/00131/AM14/ Lic.No/Date:0310745809 19.08.2013 Defer Date:11.09.2014 Decision :It was decided to defer the case 11.09.2014 for comments of Department of Chemicals and Petrochemicals. 70
Case No.:117/14/82ALC4/2013
Party Name:MAC CHEM PRODUCTS (INDIA) PRIVATE LIMITED 24.07.2014 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:25.09.2014 Decision :It was decided to call for DML (Drug Manufacturing Licence) percentage content of buffering agent in the export product from the firm. The case was deferred for 29.09.2014 71
Case No.:26/14/82ALC4/2013
24.07.2014 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:11.09.2014
72
Case No.:20/13/82ALC4/2013
Party Name:VARUN MEDIMPEX INC. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00496/AM14/ RLA File :05/24/040/00134/AM14/ Lic.No/Date:0510363085 21.08.2013 Defer Date:29.08.2014 Decision : It was decided to defer the case 29.08.2014 for comments of Department of Chemicals and Petrochemicals. 73
Case No.:3/12/82ALC4/2013
Party Name:ACTAVIS PHARMA MANUFACTURING PVT.LTD 24.07.2014 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:25.09.2014 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 29.09.2014. 74
Case No.:32/14/82ALC4/2013
Party Name:ALEMBIC PHARMACEUTICALS LTD 24.07.2014 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:11.09.2014 75
Case No.:10/17/85ALC3/2013
Party Name:BELOOR BAYIR BIOTECH LTD, 24.07.2014 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:11.09.2014 76
Case No.:47/14/82ALC4/2013
Party Name:VIVIMED LABS LIMITED 24.07.2014 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:11.09.2014 77
Case No.:90/13/82ALC4/2013
Party Name:CATAPHARMA CHEMICALS PVT. LTD., 24.07.2014 Status:Case Rejected HQ File :01/82/050/00566/AM14/ RLA File :31/83/040/00054/AM14/ Lic.No/Date:3110060069 Defer Date:
23.08.2013 Decision :Withdrawn the case has been already rejected by the NC in its 4/82 meeting dated 03.07.2014. 78
Case No.:115/14/82ALC4/2013
Party Name:RIOCARE INDIA PRIVATE LIMITED. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00700/AM14/ RLA File :03/95/040/00402/AM14/ Lic.No/Date:0310746634 23.08.2013 Defer Date:11.09.2014 Decision :Reply received and sent to Department of Pharmaceuticals for their comments. The case is deferredfor 11.09.2014. 79
Case No.:4/4/82ALC4/2014
LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00252/AM15/ RLA File :04/24/040/00107/AM14/ Lic.No/Date:0410148932 23.08.2013 Defer Date:11.09.2014 Decision :It was decided to defer the case for 11.09.2014 for comments of Department of Pharmaceuticals 80
Case No.:88/13/82ALC4/2013
Party Name:MAKCUR LABORATORIES LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00564/AM14/ RLA File :08/24/040/00232/AM14/ Lic.No/Date:0810124120 26.08.2013 Defer Date:25.09.2014 Decision :It was decided to remind the firm copy of Drug Manufacturing Licence alongwith list of Approved items showing composition of export product. The case was deferred for 25.09.2014. 81
Case No.:1/15/82ALC4/2013
Party Name:CORAL LABORATORIES LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00763/AM14/ RLA File :03/94/040/00389/AM14/ Lic.No/Date:0310747134 27.08.2013 Defer Date:11.09.2014 82
Case No.:152/14/82ALC4/2013
24.07.2014 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:11.09.2014
83
Case No.:116/14/82ALC4/2013
Party Name:UNIJULES LIFE SCIENCES LTD. 24.07.2014 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:11.09.2014 84
Case No.:25/15/82ALC4/2013
Party Name:IPCA LABORATORIES LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00787/AM14/ RLA File :03/94/040/00992/AM13/ Lic.No/Date:0310747414 28.08.2013 Defer Date:11.09.2014 85
Case No.:43/16/82ALC4/2013
Party Name:SYMBIOTEC PHARMALAB LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00856/AM14/ RLA File :56/24/040/00017/AM14/ Lic.No/Date:5610002765 03.09.2013 Defer Date:11.09.2014 86
Case No.:53/14/82ALC4/2013
Party Name:STERILE INDIA PRIVATE LIMITED 24.07.2014 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:11.09.2014 87
Case No.:176/14/82ALC4/2013
Party Name:AMI LIFESCIENCES P LTD 24.07.2014 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:11.09.2014 88
Case No.:103/14/82ALC4/2013
Party Name:INTAS PHARMACEUTICALS LTD., 24.07.2014 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:11.09.2014
89
Case No.:2/12/82ALC4/2013
Party Name:VIVEK PHARMACHEM (INDIA) LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00426/AM14/ RLA File :13/24/040/00022/AM14/ Lic.No/Date:1310044274 09.09.2013 Defer Date:11.09.2014 90
Case No.:56/14/82ALC4/2013
Party Name:VIVEK PHARMACHEM (INDIA) LTD., 24.07.2014 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:11.09.2014 91
Case No.:54/17/82ALC4/2013
Party Name:CIREX PHARMACEUTICALS LIMITED 24.07.2014 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:11.09.2014 92
Case No.:16/16/82ALC4/2013
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00829/AM14/ RLA File :07/24/040/00189/AM14/ Lic.No/Date:0710098183 10.09.2013 Defer Date:11.09.2014 93
Case No.:149/14/82ALC4/2013
Party Name:MACLEODS PHARMACEUTICALS LTD. 24.07.2014 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:11.09.2014 94
Case No.:105/13/82ALC4/2013
Party Name:RA CHEM PHARMA LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00581/AM14/ RLA File :09/24/040/00265/AM14/ Lic.No/Date:0910057516 10.09.2013 Defer Date:11.09.2014 Decision :It was decided to remind the firm to furnish complete technical details as per Appendix 33. The case was deferred for 11.09.2014
95
Case No.:11/15/82ALC4/2013
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 24.07.2014 Status:Case Deferred HQ File :01/82/050/00773/AM14/ RLA File :03/94/040/00352/AM14/ Lic.No/Date:0310749169 11.09.2013 Defer Date:11.09.2014 96
Case No.:47/16/82ALC4/2013
LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00860/AM14/ RLA File :04/24/040/00130/AM14/ Lic.No/Date:0410149741 11.09.2013 Defer Date:25.09.2014 Decision :It was decided to call from the firm a copy of Master Batch Formula duly certified by Quality Control In charge. The case was deferred for 25.09.2014 97
Case No.:33/16/82ALC4/2013
Party Name:HETERO DRUGS LIMITED, 24.07.2014 Status:Case Deferred HQ File :01/82/050/00846/AM14/ RLA File :09/24/040/00278/AM14/ Lic.No/Date:0910057537 12.09.2013 Defer Date:11.09.2014 98
Case No.:32/15/82ALC4/2013
Party Name:KOPRAN LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00794/AM14/ RLA File :03/94/040/00487/AM14/ Lic.No/Date:0310749296 12.09.2013 Defer Date:11.09.2014 99
Case No.:55/4/82ALC4/2014
Party Name:NECTAR LIFESCIENCES LIMITED, 24.07.2014 Status:Case Deferred HQ File :01/82/050/00303/AM15/ RLA File :22/24/040/00044/AM14/ Lic.No/Date:2210014211 12.09.2013 Defer Date:11.09.2014 100 Case No.:220/3/82ALC4/2014 Party Name:YASHASHVI RASAYAN PVT.LTD 24.07.2014 Status:Case Approved HQ File :01/82/050/00224/AM15/ RLA File :52/24/040/00022/AM14/ Lic.No/Date:5210040190 12.09.2013 Defer Date: Decision :In the light of wri⯒en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/36/2010‐Ch II dated
23.07.2014, it was decided to ra㘐�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 THISA 1 kg 1. THIOPHANONE 1.480 kg RA may take appropriate ac㘐�on as per the decision of Norms Commi⯒ee. 101
Case No.:63/17/82ALC4/2013
Party Name:DR REDDYS LABORATORIES LIMITED 24.07.2014 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:11.09.2014 Decision :It was decided to defer the case for 11.09.2014 for comments of Department of Pharmaceuticals 102
Case No.:35/15/82ALC4/2013
24.07.2014 Status:Case Deferred HQ File :01/82/050/00797/AM14/ RLA File :03/94/040/00472/AM14/ Lic.No/Date:0310749439 13.09.2013 Defer Date:11.09.2014 Decision :It was decided to defer the case for 11.09.2014 for comments of Department of Pharmaceuticals 103
Case No.:26/4/82ALC4/2014
Party Name:RANBAXY LABORATORIES LTD 24.07.2014 Status:Case Deferred HQ File :01/82/050/00274/AM15/ RLA File :05/24/040/00212/AM14/ Lic.No/Date:0510365650 16.09.2013 Defer Date:11.09.2014 104
Case No.:10/16/82ALC4/2013
Party Name:STERICON PHARMA PVT.LTD., 24.07.2014 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:25.09.2014 Decision :It was decided to remind the firm to furnish a copy of Drug Manufacturing licence, from the firm, for each export item. The case was deferred for 25.09.2014 105 Case No.:151/14/82ALC4/2013 Party Name:THINQ PHARMACRO LIMITED 24.07.2014 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:11.09.2014 Decision :It was decided to remind the firm to furnish complete technical details as per Appendix 33. The case was deferred for 11.09.2014 106
Case No.:35/17/82ALC4/2013
Party Name:S M S PHARMACEUTICALS LTD 24.07.2014 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:25.09.2014 Decision :It was decided to call from the firm complete technical details as per Appendix 33. The case was deferred for 25.09.2014. 107
Case No.:46/16/82ALC4/2013
LIMITED 24.07.2014 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:25.09.2014 Decision :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 25.09.2014 108
Case No.:49/16/82ALC4/2013
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 24.07.2014 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:11.09.2014 109
Case No.:68/14/82ALC4/2013
Party Name:NIFTY LABS PVT LTD., 24.07.2014 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:11.09.2014 110
Case No.:30/4/82ALC4/2014
Party Name:RA CHEM PHARMA LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00278/AM15/ RLA File :09/24/040/00119/AM14/ Lic.No/Date:0910057629 19.09.2013 Defer Date:11.09.2014 111
Case No.:64/17/82ALC4/2013
Party Name:RA CHEM PHARMA LIMITED Status:Case
24.07.2014 Deferred HQ File :01/82/050/00926/AM14/ RLA File :09/24/040/00120/AM14/ Lic.No/Date:0910057630 19.09.2013 Defer Date:11.09.2014 112
Case No.:81/23/82ALC4/2013
Party Name:RANBAXY LABORATORIES LTD 24.07.2014 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:11.09.2014 113
Case No.:18/4/82ALC4/2014
LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00266/AM15/ RLA File :04/24/040/00137/AM14/ Lic.No/Date:0410150092 19.09.2013 Defer Date:11.09.2014 114
Case No.:53/17/82ALC4/2013
Party Name:HETERO DRUGS LIMITED, 24.07.2014 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:11.09.2014 115
Case No.:48/16/82ALC4/2013
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00861/AM14/ RLA File :04/24/040/00099/AM14/ Lic.No/Date:0410150142 20.09.2013 Defer Date:11.09.2014 116
Case No.:48/15/82ALC4/2013
LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00810/AM14/ RLA File :04/24/040/00128/AM14/ Lic.No/Date:0410150198 23.09.2013 Defer Date:11.09.2014 Decision :It was decided to call from the firm a copy of Master Batch Formula duly certified by Quality Control In charge. The case was deferred for 11.09.2014 .
117
Case No.:41/4/82ALC4/2014
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 24.07.2014 Status:Case Deferred HQ File :01/82/050/00289/AM15/ RLA File :09/24/040/00297/AM14/ Lic.No/Date:0910057666 24.09.2013 Defer Date:11.09.2014 118
Case No.:62/17/82ALC4/2013
Party Name:SMILAX LABORATORIES LIMITED Meet No/Date:5/82ALC4/2014 24.07.2014 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:11.09.2014 119
Case No.:36/16/82ALC4/2013
Party Name:CADILA HEALTHCARE LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00849/AM14/ RLA File :08/24/040/00259/AM14/ Lic.No/Date:0810125075 25.09.2013 Defer Date:11.09.2014 120
Case No.:21/19/82ALC4/2013
Party Name:GOPALDAS VISRAM & CO.LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00966/AM14/ RLA File :03/94/040/00502/AM14/ Lic.No/Date:0310751325 26.09.2013 Defer Date:11.09.2014 121
Case No.:14/16/82ALC4/2013
Party Name:SHAMSHREE LIFESCIENCES LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00827/AM14/ RLA File :22/24/040/00046/AM14/ Lic.No/Date:2210014253 30.09.2013 Defer Date:11.09.2014 122
Case No.:41/17/82ALC4/2013
Party Name:HETERO LABS LIMITED 24.07.2014 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:11.09.2014
123 Case No.:46/17/82ALC4/2013 Party Name:INCHEM LABORATORIES PRIVATE LIMITED 24.07.2014 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:11.09.2014 124
Case No.:48/17/82ALC4/2013
Party Name:INCHEM LABORATORIES PRIVATE LIMITED 24.07.2014 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:11.09.2014 125
Case No.:32/16/82ALC4/2013
Party Name:FINE CURE PHARMACEUTICALS LTD. 24.07.2014 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:11.09.2014 126
Case No.:39/16/82ALC4/2013
Party Name:SANMAR SPECIALITY CHEMICALS LIMITED, 24.07.2014 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:11.09.2014 127
Case No.:26/17/82ALC4/2013
24.07.2014 Status:Case Deferred HQ File :01/82/050/00888/AM14/ RLA File :09/24/040/00302/AM14/ Lic.No/Date:0910057816 04.10.2013 Defer Date:11.09.2014 128
Case No.:34/19/82ALC4/2013
Party Name:ELPPE CHEMICALS PRIVATE LIMITED 24.07.2014 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:11.09.2014
129 Case No.:12/16/82ALC4/2013 Party Name:INTAS PHARMACEUTICALS LTD., 24.07.2014 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:11.09.2014 130
Case No.:26/16/82ALC4/2013
Party Name:INTAS PHARMACEUTICALS LTD., 24.07.2014 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:11.09.2014 131
Case No.:27/17/82ALC4/2013
Party Name:EYTAN LABS LIMITED 24.07.2014 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:11.09.2014 132
Case No.:73/14/82ALC4/2013
Party Name:MSN LABORATORIES PRIVATE LIMITED 24.07.2014 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:11.09.2014 133
Case No.:36/17/82ALC4/2013
24.07.2014 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:11.09.2014 134
Case No.:28/16/82ALC4/2013
Party Name:NECTAR LIFESCIENCES LIMITED, 24.07.2014 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:11.09.2014
135 Case No.:6/17/82ALC4/2013 Party Name:AMI ORGANICS PVT LTD. 24.07.2014 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:11.09.2014 136
Case No.:55/17/82ALC4/2013
Party Name:SHODHANA LABORATORIES LTD 24.07.2014 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:11.09.2014 137
Case No.:137/23/82ALC4/2013
Party Name:MANGALAM DRUGS & ORGANICS LIMITED 24.07.2014 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:11.09.2014 138
Case No.:37/17/82ALC4/2013
24.07.2014 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:11.09.2014 139
Case No.:38/16/82ALC4/2013
Party Name:INTAS PHARMACEUTICALS LTD., 24.07.2014 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:11.09.2014 140
Case No.:38/17/82ALC4/2013
24.07.2014 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:11.09.2014
141 Case No.:18/16/82ALC4/2013 Party Name:NEULAND LABORATORIES LTD 24.07.2014 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:11.09.2014 142
Case No.:39/17/82ALC4/2013
Party Name:ASTRIX LABORATORIES LTD., 24.07.2014 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:11.09.2014 143
Case No.:22/17/82ALC4/2013
Party Name:ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED 24.07.2014 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:11.09.2014 144
Case No.:67/17/82ALC4/2013
Party Name:COVALENT LABORATORIES PRIVATE LIMITED 24.07.2014 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:11.09.2014 145
Case No.:17/4/82ALC4/2014
Party Name:NAPROD LIFE SCIENCES PVT. LTD. Meet No/Date:5/82ALC4/2014 24.07.2014 Status:Case Deferred HQ File :01/82/050/00265/AM15/ RLA File :03/95/040/00563/AM14/ Lic.No/Date:0310754049 17.10.2013 Defer Date:11.09.2014 146
Case No.:19/4/82ALC4/2014
Party Name:SAVLA CHEMICALS LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00267/AM15/ RLA File :03/95/040/00566/AM14/ Lic.No/Date:0310754070 17.10.2013 Defer Date:11.09.2014 Decision :It was decided to defer the case for 11.09.2014 for comments of Department of C&PC..
147 Case No.:59/17/82ALC4/2013 Party Name:INDSWIFT LABORATORIES LTD., 24.07.2014 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:11.09.2014 148
Case No.:108/23/82ALC4/2013
Party Name:SYMBIOTEC PHARMALAB LTD., 24.07.2014 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:11.09.2014 149
Case No.:138/23/82ALC4/2013
Party Name:MIDAS CARE PHARMACEUTICALS PVT LTD 24.07.2014 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:11.09.2014 Decision :Decision :It was decided to send a copy of application again to Department of C&PC for their comments. The case was deferred for 11.09.2014 150
Case No.:100/23/82ALC4/2013
Party Name:SYMBIOTEC PHARMALAB LTD., 24.07.2014 Status:Deffered and Reindexed HQ File :01/82/050/01147/AM14/ RLA File :56/24/040/00025/AM14/ Lic.No/Date:5610003085 25.10.2013 Defer Date:24.07.2014 151
Case No.:14/19/82ALC4/2013
Party Name:BLISS GVS PHARMA LTD. 24.07.2014 Status:Deffered and Reindexed HQ File :01/82/050/00959/AM14/ RLA File :03/94/040/00687/AM14/ Lic.No/Date:0310756546 01.11.2013 Defer Date:24.07.2014 152 Case No.:7/23/82ALC4/2013 Party Name:JESONS INDUSTRIES LTD. 24.07.2014 Status:Approved HQ File :01/82/050/01054/AM14/ RLA File :03/94/040/00713/AM14/ Lic.No/Date:0310757929 14.11.2013 Defer Date: Decision :In the light of wri⯒en comments received from Petrochemical Division of Department of Chemicals and Petrochemicals vide their U.O No. 46011/93/2011‐PC‐ II dated 14.08.2014, it was decided to ra㘐�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 CHEMCOAT V V 10 1 kg 1. VINYL ACETATE MONOMER 0.050 kg 2. VEOVA 10 Monomer 0.950 kg 153
Case No.:66/23/82ALC4/2013
Party Name:STERICON PHARMA PVT.LTD., 24.07.2014 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:11.09.2014 Decision :Decision :It was decided to defer the case for 11.09.2014 for comments of Department of Pharmaceuticals. 154
Case No.:40/19/82ALC4/2013
Party Name:INDO PHYTO CHEMICALS PVT LTD 24.07.2014 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:11.09.2014 155
Case No.:140/23/82ALC4/2013
Party Name:UNITED PHOSPHORUS LTD. 24.07.2014 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:11.09.2014 156
Case No.:101/23/82ALC4/2013
Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 24.07.2014 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:11.09.2014 157
Case No.:129/23/82ALC4/2013
Party Name:HETERO LABS LIMITED 24.07.2014 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:11.09.2014 Decision : It was decided to defer the case for 11.09.2014 for comments of Department of Pharmaceuticals.
158
Case No.:77/23/82ALC4/2013
LIMITED 24.07.2014 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:11.09.2014 159
Case No.:94/23/82ALC4/2013
Party Name:DHANUKA LABORATORIES LTD. 24.07.2014 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:11.09.2014 160
Case No.:148/23/82ALC4/2013
Party Name:CTX LIFESCIENCES PVT LTD, 24.07.2014 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:11.09.2014 161
Case No.:147/23/82ALC4/2013
Party Name:AGIO PHARMACEUTICALS LTD 24.07.2014 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:11.09.2014 162
Case No.:112/23/82ALC4/2013
Party Name:CADILA HEALTHCARE LTD., 24.07.2014 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:11.09.2014 163
Case No.:66/3/82ALC4/2014
Party Name:GLAND PHARMA LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00070/AM15/ RLA File :09/24/040/00422/AM14/ Lic.No/Date:0910058454 04.12.2013 Defer Date:11.09.2014
164
Case No.:116/23/82ALC4/2013
Party Name:ALCHEM INTERNATIONAL LTD. 24.07.2014 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:11.09.2014 165
Case No.:18/23/82ALC4/2013
Party Name:NAPROD LIFE SCIENCES PVT. LTD. Meet No/Date:5/82ALC4/2014 24.07.2014 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:11.09.2014 166
Case No.:138/3/82ALC4/2014
24.07.2014 Status:Case Deferred HQ File :01/82/050/00142/AM15/ RLA File :09/24/040/00424/AM14/ Lic.No/Date:0910058481 06.12.2013 Defer Date:11.09.2014 167
Case No.:120/3/82ALC4/2014
Party Name:INCHEM LABORATORIES PRIVATE LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00124/AM15/ RLA File :09/24/040/00416/AM14/ Lic.No/Date:0910058483 06.12.2013 Defer Date:11.09.2014 168
Case No.:115/3/82ALC4/2014
Party Name:NECTAR LIFESCIENCES LIMITED, 24.07.2014 Status:Case Deferred HQ File :01/82/050/00119/AM15/ RLA File :22/24/040/00068/AM14/ Lic.No/Date:2210014426 06.12.2013 Defer Date:11.09.2014 169
Case No.:4/5/82ALC4/2014
LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00321/AM15/ RLA File :04/24/040/00198/AM14/ Lic.No/Date:0410152693 06.12.2013 Defer Date:11.09.2014
170
Case No.:96/23/82ALC4/2013
Party Name:MOREPEN LABORATORIES LTD., 24.07.2014 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:11.09.2014 171
Case No.:63/23/82ALC4/2013
Party Name:AMI ORGANICS PVT LTD. 24.07.2014 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:11.09.2014 Decision :Decision :It was decided to defer the case for 11.09.2014 for comments of Department of C&PC. 172
Case No.:95/23/82ALC4/2013
Party Name:JAGSONPAL PHARMACEUTICALS LTD. 24.07.2014 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:11.09.2014 173
Case No.:137/3/82ALC4/2014
Party Name:SUVEN LIFE SCIENCES LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00141/AM15/ RLA File :09/24/040/00427/AM14/ Lic.No/Date:0910058555 11.12.2013 Defer Date:11.09.2014 174
Case No.:141/3/82ALC4/2014
Party Name:COVALENT LABORATORIES PRIVATE LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00145/AM15/ RLA File :09/24/040/00418/AM14/ Lic.No/Date:0910058567 12.12.2013 Defer Date:11.09.2014 175
Case No.:115/23/82ALC4/2013
Party Name:ALCHEM INTERNATIONAL LTD. 24.07.2014 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:11.09.2014
176
Case No.:136/3/82ALC4/2014
24.07.2014 Status:Case Approved HQ File :01/82/050/00140/AM15/ RLA File :09/24/040/00438/AM14/ Lic.No/Date:0910058582 13.12.2013 Defer Date: Decision :Withdrawn the case has been already approved by NC in its 3/82 meeting dated 08.05.2014. 177
Case No.:139/3/82ALC4/2014
Party Name:SMILAX LABORATORIES LIMITED Meet No/Date:5/82ALC4/2014 24.07.2014 Status:Case Deferred HQ File :01/82/050/00143/AM15/ RLA File :09/24/040/00441/AM14/ Lic.No/Date:0910058595 13.12.2013 Defer Date:11.09.2014 178
Case No.:83/23/82ALC4/2013
Party Name:SHIVA PHARMACHEM LTD, 24.07.2014 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:11.09.2014 179
Case No.:33/3/82ALC4/2014
Party Name:HETERO DRUGS LIMITED, 24.07.2014 Status:Case Deferred HQ File :01/82/050/00037/AM15/ RLA File :09/24/040/00466/AM14/ Lic.No/Date:0910058622 17.12.2013 Defer Date:11.09.2014 180
Case No.:119/3/82ALC4/2014
Party Name:HETERO LABS LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00123/AM15/ RLA File :09/24/040/00470/AM14/ Lic.No/Date:0910058620 17.12.2013 Defer Date:11.09.2014 Decision : It was decided to defer the case 11.09.2014 for comments of Department of Pharmaceuticals. 181
Case No.:98/3/82ALC4/2014
24.07.2014 Status:Case Deferred HQ File :01/82/050/00102/AM15/ RLA File :09/24/040/00448/AM14/ Lic.No/Date:0910058626 17.12.2013 Defer Date:11.09.2014 Decision : It was decided to defer the case 11.09.2014 for comments of Department of Chemicals and Petrochemicals.
182
Case No.:39/23/82ALC4/2013
Party Name:AARTI INDUSTRIES LIMITED 24.07.2014 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:11.09.2014 Decision : It was decided to defer the case 11.09.2014 for comments of Department of Chemicals and Petrochemicals. 183
Case No.:50/23/82ALC4/2013
Party Name:AARTI INDUSTRIES LIMITED 24.07.2014 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:11.09.2014 Decision : It was decided to defer the case 11.09.2014 for comments of Department of Pharmaceuticals. 184
Case No.:68/3/82ALC4/2014
Party Name:PORUS LABORATORIES PVT LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00072/AM15/ RLA File :09/24/040/00463/AM14/ Lic.No/Date:0910058633 18.12.2013 Defer Date:11.09.2014 Decision : It was decided to send a copy of application to Department of Pharmaceuticals for their comments. The case is deferred for 11.09.2014. 185
Case No.:146/3/82ALC4/2014
Party Name:LOUIS PHARMACEUTICALS PVT LTD 24.07.2014 Status:Case Deferred HQ File :01/82/050/00150/AM15/ RLA File :09/24/040/00476/AM14/ Lic.No/Date:0910058653 19.12.2013 Defer Date:11.09.2014 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/724/2013PI(Norms) dated 21.04.2014, it was decided to call from the firm following information: (a) Complete technical details as per Appendix 33. (b) COA of imported R.M. from the Foreign Supplier. (c) COA of the export item. (d) Past production visàvis actual consumption of inputs duly certified by Central Excise Authority. The case was deferred for 11.09.2014 186 Case No.:89/23/82ALC4/2013 Party Name:RENOWN PHARMACEUTICALS PVT LTD 24.07.2014 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:11.09.2014
187
Case No.:85/23/82ALC4/2013
Party Name:PARENTERAL DRUGS (INDIA) LTD., 24.07.2014 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:11.09.2014 188
Case No.:145/3/82ALC4/2014
24.07.2014 Status:Case Deferred HQ File :01/82/050/00149/AM15/ RLA File :09/24/040/00465/AM14/ Lic.No/Date:0910058692 23.12.2013 Defer Date:11.09.2014 189
Case No.:11/3/82ALC4/2014
Party Name:MICRO LABS LTD 24.07.2014 Status:Case Deferred HQ File :01/82/050/00015/AM15/ RLA File :07/24/040/00318/AM14/ Lic.No/Date:0710100791 23.12.2013 Defer Date:11.09.2014 190
Case No.:41/23/82ALC4/2013
Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED 24.07.2014 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:11.09.2014 191
Case No.:27/23/82ALC4/2013
Party Name:SANDOZ PRIVATE LIMITED 24.07.2014 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:11.09.2014 192 Case No.:142/3/82ALC4/2014 Party Name:SRIAM LABS PRIVATE LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00146/AM15/ RLA File :09/24/040/00439/AM14/ Lic.No/Date:0910058708 24.12.2013 Defer Date:11.09.2014
Decision : It was decided to defer the case 11.09.2014 for comments of Department of Chemicals and Petrochemicals 193
Case No.:157/3/82ALC4/2014
Party Name:ATLAS FINE CHEMICALS PVT LTD Meet No/Date:5/82ALC4/2014 24.07.2014 Status:Case Deferred HQ File :01/82/050/00161/AM15/ RLA File :03/94/040/00647/AM14/ Lic.No/Date:0310763403 26.12.2013 Defer Date:11.09.2014 Decision : It was decided to defer the case 11.09.2014 for comments of Department of Chemicals and Petrochemicals. 194
Case No.:97/3/82ALC4/2014
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 24.07.2014 Status:Case Deferred HQ File :01/82/050/00101/AM15/ RLA File :09/24/040/00482/AM14/ Lic.No/Date:0910058730 26.12.2013 Defer Date:11.09.2014 195
Case No.:144/3/82ALC4/2014
Party Name:SRINI PHARMACEUTICALS LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00148/AM15/ RLA File :09/24/040/00471/AM14/ Lic.No/Date:0910058728 26.12.2013 Defer Date:11.09.2014 196
Case No.:71/23/82ALC4/2013
Party Name:RANBAXY LABORATORIES LTD 24.07.2014 Status:Case Deferred HQ File :01/82/050/01118/AM14/ RLA File :05/24/040/00317/AM14/ Lic.No/Date:0510374576 27.12.2013 Defer Date:11.09.2014 Decision :Decision :It was decided to defer the case for 11.09.2014 for comments of Department of Pharmaceuticals 197
Case No.:64/23/82ALC4/2013
Party Name:S.M. HERBALS PVT.LTD. 24.07.2014 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:11.09.2014 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 11.09.2014. 198 Case No.:143/3/82ALC4/2014 24.07.2014 Status:Case Deferred
HQ File :01/82/050/00147/AM15/ RLA File :09/24/040/00461/AM14/ Lic.No/Date:0910058745 27.12.2013 Defer Date:11.09.2014 Decision :Decision :It was decided to defer the case 11.09.2014 for comments of Department of Chemicals and Petrochemicals. 199
Case No.:43/23/82ALC4/2013
Party Name:ANUH PHARMA LTD. 24.07.2014 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:11.09.2014 200
Case No.:48/23/82ALC4/2013
Party Name:EXCEL INDUSTRIES LIMITED 24.07.2014 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:11.09.2014 201
Case No.:22/3/82ALC4/2014
Party Name:GLAND PHARMA LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00026/AM15/ RLA File :09/24/040/00485/AM14/ Lic.No/Date:0910058787 31.12.2013 Defer Date:11.09.2014 202
Case No.:96/3/82ALC4/2014
Party Name:GLAND PHARMA LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00100/AM15/ RLA File :09/24/040/00481/AM14/ Lic.No/Date:0910058788 31.12.2013 Defer Date:11.09.2014 203
Case No.:23/3/82ALC4/2014
Party Name:MSN LABORATORIES PRIVATE LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00027/AM15/ RLA File :09/24/040/00486/AM14/ Lic.No/Date:0910058791 31.12.2013 Defer Date:11.09.2014 204 Case No.:88/3/82ALC4/2014 24.07.2014 Status:Case Deferred
HQ File :01/82/050/00092/AM15/ RLA File :09/24/040/00451/AM14/ Lic.No/Date:0910058792 31.12.2013 Defer Date:11.09.2014 205
Case No.:244/3/82ALC4/2014
Party Name:SAFECON LIFESCIENCES 24.07.2014 Status:Case Deferred HQ File :01/82/050/00248/AM15/ RLA File :61/24/040/00023/AM14/ Lic.No/Date:6110001119 31.12.2013 Defer Date:11.09.2014 Decision : It was decided to defer the case for 11.09.2014 for comments of Department of Pharmaceuticals 206
Case No.:55/23/82ALC4/2013
Party Name:SATYAJIT CHEMICALS PVT.LTD., 24.07.2014 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:11.09.2014 Decision : It was decided to defer the case for 11.09.2014 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals 207
Case No.:53/23/82ALC4/2013
Party Name:EXCEL INDUSTRIES LIMITED 24.07.2014 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:11.09.2014 208
Case No.:114/3/82ALC4/2014
Party Name:HETERO LABS LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00118/AM15/ RLA File :09/24/040/00497/AM14/ Lic.No/Date:0910058802 02.01.2014 Defer Date:11.09.2014 209
Case No.:38/3/82ALC4/2014
Party Name:PARENTERAL DRUGS (INDIA) LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00042/AM15/ RLA File :56/24/040/00036/AM14/ Lic.No/Date:5610003472 02.01.2014 Defer Date:11.09.2014 210 Case No.:118/3/82ALC4/2014 Party Name:PARENTERAL DRUGS (INDIA) Status:Case
LTD., 24.07.2014 Deferred HQ File :01/82/050/00122/AM15/ RLA File :56/24/040/00035/AM14/ Lic.No/Date:5610003471 02.01.2014 Defer Date:11.09.2014 211
Case No.:24/3/82ALC4/2014
24.07.2014 Status:Case Deferred HQ File :01/82/050/00028/AM15/ RLA File :09/24/040/00492/AM14/ Lic.No/Date:0910058808 02.01.2014 Defer Date:11.09.2014 Decision :It was decided to defer the case for 11.09.2014 for comments of Department of C&PC. 212
Case No.:45/3/82ALC4/2014
Party Name:AKZO NOBEL INDIA LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00049/AM15/ RLA File :02/24/040/00168/AM13/ Lic.No/Date:0210198458 03.01.2014 Defer Date:11.09.2014 213
Case No.:89/3/82ALC4/2014
Party Name:ASTRIX LABORATORIES LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00093/AM15/ RLA File :09/24/040/00496/AM14/ Lic.No/Date:0910058826 06.01.2014 Defer Date:11.09.2014 214
Case No.:186/3/82ALC4/2014
24.07.2014 Status:Case Deferred HQ File :01/82/050/00190/AM15/ RLA File :09/24/040/00484/AM14/ Lic.No/Date:0910058825 06.01.2014 Defer Date:11.09.2014 215
Case No.:193/3/82ALC4/2014
Party Name:NATCO PHARMA LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00197/AM15/ RLA File :09/24/040/00494/AM14/ Lic.No/Date:0910058829 06.01.2014 Defer Date:11.09.2014 216 Case No.:37/3/82ALC4/2014 Party Name:NECTAR LIFESCIENCES LIMITED, Status:Case
24.07.2014 Deferred HQ File :01/82/050/00041/AM15/ RLA File :22/24/040/00077/AM14/ Lic.No/Date:2210014502 07.01.2014 Defer Date:11.09.2014 217
Case No.:121/3/82ALC4/2014
Party Name:NECTAR LIFESCIENCES LIMITED, 24.07.2014 Status:Case Deferred HQ File :01/82/050/00125/AM15/ RLA File :22/24/040/00078/AM14/ Lic.No/Date:2210014501 07.01.2014 Defer Date:11.09.2014 218
Case No.:116/3/82ALC4/2014
Party Name:VIJAYASRI ORGANICS LTD 24.07.2014 Status:Case Deferred HQ File :01/82/050/00120/AM15/ RLA File :09/24/040/00402/AM14/ Lic.No/Date:0910058840 07.01.2014 Defer Date:11.09.2014 219
Case No.:180/3/82ALC4/2014
Party Name:VISION DRUGS PVT LTD 24.07.2014 Status:Case Deferred HQ File :01/82/050/00184/AM15/ RLA File :09/24/040/00426/AM14/ Lic.No/Date:0910058839 07.01.2014 Defer Date:11.09.2014 220
Case No.:90/3/82ALC4/2014
Party Name:SUVEN LIFE SCIENCES LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00094/AM15/ RLA File :09/24/040/00468/AM14/ Lic.No/Date:0910058858 08.01.2014 Defer Date:11.09.2014 221 Case No.:203/3/82ALC4/2014 Party Name:VINS BIOPRODUCTS LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00207/AM15/ RLA File :09/24/040/00362/AM14/ Lic.No/Date:0910058863 08.01.2014 Defer Date:11.09.2014 Decision : Department of Biotechnology vide their letter No. BT/IL/05/382/2013PID dated 29.08.2013 has mentioned that the norms for the export item called DTPHEPB (Pentavalent Vaccine) fully liquid combination vaccine single does vial, Pediatric does Diphtheria, Tetanus, Pertussis, Hepatitis B Recombinant and Heamophilus Type in the application. You are requested to furnish the following information:
Drug Manufacturing Licensing of the export product (DML enclosed with the application does not mention the export product. To submit QA approved Batch Manufacturing Record. Complete technical details as per Appendix 33. The case was deferred for 11.09.2014. 222
Case No.:200/3/82ALC4/2014
Party Name:WEXFORD LABORATORIES P LTD 24.07.2014 Status:Case Deferred HQ File :01/82/050/00204/AM15/ RLA File :07/24/040/00333/AM14/ Lic.No/Date:0710101186 08.01.2014 Defer Date:11.09.2014 223
Case No.:21/23/82ALC4/2013
Party Name:UNITED PHOSPHORUS LTD. 24.07.2014 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:11.09.2014 Decision :Decision :It was decided to defer the case for 11.09.2014 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals 224
Case No.:194/3/82ALC4/2014
Party Name:LOUIS PHARMACEUTICALS PVT LTD 24.07.2014 Status:Case Deferred HQ File :01/82/050/00198/AM15/ RLA File :09/24/040/00520/AM14/ Lic.No/Date:0910058903 10.01.2014 Defer Date:11.09.2014 225
Case No.:192/3/82ALC4/2014
24.07.2014 Status:Case Deferred HQ File :01/82/050/00196/AM15/ RLA File :09/24/040/00513/AM14/ Lic.No/Date:0910058896 10.01.2014 Defer Date:11.09.2014 Decision : It was decided to defer the case for 11.09.2014 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals 226
Case No.:204/3/82ALC4/2014
24.07.2014 Status:Case Deferred HQ File :01/82/050/00208/AM15/ RLA File :09/24/040/00514/AM14/ Lic.No/Date:0910058895 10.01.2014 Defer Date:11.09.2014
227
Case No.:19/23/82ALC4/2013
Party Name:DANOPHARM CHEMICALS PRIVATE LTD. 24.07.2014 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:11.09.2014 228
Case No.:197/3/82ALC4/2014
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00201/AM15/ RLA File :04/24/040/00218/AM14/ Lic.No/Date:0410154188 13.01.2014 Defer Date:11.09.2014 229
Case No.:134/3/82ALC4/2014
LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00138/AM15/ RLA File :04/24/040/00226/AM14/ Lic.No/Date:0410154220 13.01.2014 Defer Date:11.09.2014 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/715/2013PI(Norms) dated 21.04.2014, 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 11.09.2014. 230
Case No.:179/3/82ALC4/2014
Party Name:VENUS REMEDIES LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00183/AM15/ RLA File :22/24/040/00079/AM14/ Lic.No/Date:2210014517 13.01.2014 Defer Date:11.09.2014 231
Case No.:196/3/82ALC4/2014
Party Name:ARUDAA VIS LABS PRIVATE LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00200/AM15/ RLA File :04/24/040/00219/AM14/ Lic.No/Date:0410154292 15.01.2014 Defer Date:11.09.2014 232 Case No.:182/3/82ALC4/2014 24.07.2014 Status:Case Deferred HQ File :01/82/050/00186/AM15/ RLA File :09/24/040/00516/AM14/ Lic.No/Date:0910058925
Q 15.01.2014 Defer Date:11.09.2014 233
Case No.:26/23/82ALC4/2013
Party Name:RIOCARE INDIA PRIVATE LIMITED. 24.07.2014 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:11.09.2014 Decision :Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/635/2013 PI(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 11.09.2014. 234
Case No.:202/3/82ALC4/2014
Party Name:PARENTERAL DRUGS (INDIA) LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00206/AM15/ RLA File :56/24/040/00041/AM14/ Lic.No/Date:5610003580 16.01.2014 Defer Date:11.09.2014 235
Case No.:198/3/82ALC4/2014
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 24.07.2014 Status:Case Deferred HQ File :01/82/050/00202/AM15/ RLA File :09/24/040/00523/AM14/ Lic.No/Date:0910058953 16.01.2014 Defer Date:11.09.2014 236
Case No.:32/3/82ALC4/2014
Party Name:DISTO PHARMACEUTICALS PRIVATE LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00036/AM15/ RLA File :09/24/040/00519/AM14/ Lic.No/Date:0910058977 17.01.2014 Defer Date:11.09.2014 237 Case No.:42/3/82ALC4/2014 Party Name:PAYAL POLYPLAST PVT.LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00046/AM15/ RLA File :05/24/040/00204/AM14/ Lic.No/Date:0510376324 Defer
17.01.2014 Date:11.09.2014 Decision :Decision :It was decided to defer the case for 11.09.2014 for comments of Department of C&PC. 238
Case No.:103/3/82ALC4/2014
Party Name:BLISS GVS PHARMA LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00107/AM15/ RLA File :03/94/040/00942/AM14/ Lic.No/Date:0310767119 21.01.2014 Defer Date:11.09.2014 239
Case No.:156/3/82ALC4/2014
Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00160/AM15/ RLA File :03/95/040/00796/AM14/ Lic.No/Date:0310767045 21.01.2014 Defer Date:11.09.2014 Decision :Decision :It was decided to defer the case for 11.09.2014 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals 240
Case No.:55/3/82ALC4/2014
24.07.2014 Status:Case Deferred HQ File :01/82/050/00059/AM15/ RLA File :09/24/040/00529/AM14/ Lic.No/Date:0910059025 23.01.2014 Defer Date:11.09.2014 241
Case No.:60/3/82ALC4/2014
24.07.2014 Status:Case Deferred HQ File :01/82/050/00064/AM15/ RLA File :09/24/040/00541/AM14/ Lic.No/Date:0910059028 23.01.2014 Defer Date:11.09.2014 242
Case No.:21/3/82ALC4/2014
Party Name:KUDOS CHEMIE LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00025/AM15/ RLA File :22/24/040/00075/AM14/ Lic.No/Date:2210014543 23.01.2014 Defer Date:11.09.2014 243 Case No.:12/21/82ALC4/2013 Party Name:KUDOS CHEMIE LTD., 24.07.2014 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:11.09.2014 244
Case No.:187/3/82ALC4/2014
Party Name:ALCHEM INTERNATIONAL LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00191/AM15/ RLA File :05/23/040/00413/AM14/ Lic.No/Date:0510376990 24.01.2014 Defer Date:11.09.2014 245
Case No.:108/3/82ALC4/2014
Party Name:CROPNOSYS (INDIA) PRIVATE LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00112/AM15/ RLA File :03/94/040/00908/AM14/ Lic.No/Date:0310767733 24.01.2014 Defer Date:11.09.2014 Decision :Decision :It was decided to defer the case for 11.09.2014 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals. 246
Case No.:158/3/82ALC4/2014
Party Name:PRACHI PHARMACEUTICALS PVT LTD 24.07.2014 Status:Case Deferred HQ File :01/82/050/00162/AM15/ RLA File :03/95/040/00862/AM14/ Lic.No/Date:0310768015 27.01.2014 Defer Date:11.09.2014 247
Case No.:159/3/82ALC4/2014
Party Name:PRACHI PHARMACEUTICALS PVT LTD 24.07.2014 Status:Case Deferred HQ File :01/82/050/00163/AM15/ RLA File :03/95/040/00861/AM14/ Lic.No/Date:0310768009 27.01.2014 Defer Date:11.09.2014 248
Case No.:19/3/82ALC4/2014
Party Name:VARUN MEDIMPEX INC. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00023/AM15/ RLA File :05/24/040/00374/AM14/ Lic.No/Date:0510377141 27.01.2014 Defer Date:11.09.2014 Decision :Decision :It was decided to defer the case for 11.09.2014 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals
249 Case No.:174/3/82ALC4/2014 Party Name:IPCA LABORATORIES LIMITED 24.07.2014 Status:Case Approved HQ File :01/82/050/00178/AM15/ RLA File :03/94/040/00923/AM14/ Lic.No/Date:0310768207 28.01.2014 Defer Date: Decision :withdrawn the case has been already approved by the NC in its 3/82 meeting dated 08.05.2014 250
Case No.:175/3/82ALC4/2014
Party Name:IPCA LABORATORIES LIMITED 24.07.2014 Status:Case Approved HQ File :01/82/050/00179/AM15/ RLA File :03/94/040/00932/AM14/ Lic.No/Date:0310768214 28.01.2014 Defer Date: Decision : withdrawn the case has been already approved by the NC in its 3/82 meeting dated 08.05.2014 251
Case No.:104/3/82ALC4/2014
Party Name:SIRMAXO CHEMICALS PVT LTD 24.07.2014 Status:Case Approved HQ File :01/82/050/00108/AM15/ RLA File :03/95/040/00863/AM14/ Lic.No/Date:0310768423 29.01.2014 Defer Date: Decision : withdrawn the case has been already approved by the NC in its 3/82 meeting dated 08.05.2014 252
Case No.:230/3/82ALC4/2014
Party Name:SWISS EXPORTS PVT. LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00234/AM15/ RLA File :08/24/040/00474/AM14/ Lic.No/Date:0810128498 29.01.2014 Defer Date:11.09.2014 253
Case No.:209/3/82ALC4/2014
Party Name:DR REDDYS LABORATORIES LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00213/AM15/ RLA File :09/24/040/00540/AM14/ Lic.No/Date:0910059127 30.01.2014 Defer Date:11.09.2014 254
Case No.:177/3/82ALC4/2014
Party Name:INDO AMINES LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00181/AM15/ RLA File :03/94/040/00958/AM14/ Lic.No/Date:0310768616 30.01.2014 Defer Date:11.09.2014 Decision :Decision :It was decided to defer the case for 11.09.2014 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals
255
Case No.:223/3/82ALC4/2014
Party Name:UNIJULES LIFE SCIENCES LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00227/AM15/ RLA File :03/95/040/00867/AM14/ Lic.No/Date:0310768632 30.01.2014 Defer Date:11.09.2014 256
Case No.:206/3/82ALC4/2014
24.07.2014 Status:Case Deferred HQ File :01/82/050/00210/AM15/ RLA File :09/24/040/00556/AM14/ Lic.No/Date:0910059129 31.01.2014 Defer Date:11.09.2014 257
Case No.:165/3/82ALC4/2014
Party Name:MANGALAM ORGANICS LIMITED. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00169/AM15/ RLA File :03/94/040/00448/AM14/ Lic.No/Date:0310768928 03.02.2014 Defer Date:11.09.2014 Decision :Decision :It was decided to defer the case for 11.09.2014 for comments of Department of C&PC. 258
Case No.:111/3/82ALC4/2014
Party Name:SRIAM LABS PRIVATE LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00115/AM15/ RLA File :09/24/040/00509/AM14/ Lic.No/Date:0910059150 03.02.2014 Defer Date:11.09.2014 259
Case No.:201/3/82ALC4/2014
Party Name:YASHASHVI RASAYAN PVT.LTD 24.07.2014 Status: Approved HQ File :01/82/050/00205/AM15/ RLA File :52/24/040/00045/AM14/ Lic.No/Date:5210040666 03.02.2014 Defer Date: Decision : In the light of wri⯒en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/36/2010‐Ch II dated 23.07.2014, it was decided to ra㘐�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 THISA 1 kg 1. THIOPHANONE 1.480 kg
260
Case No.:26/3/82ALC4/2014
Party Name:MEDICEF PHARMA, 24.07.2014 Status:Case Deferred HQ File :01/82/050/00030/AM15/ RLA File :22/24/040/00080/AM14/ Lic.No/Date:2210014587 04.02.2014 Defer Date:11.09.2014 261
Case No.:27/3/82ALC4/2014
Party Name:MEDICEF PHARMA, 24.07.2014 Status:Case Deferred HQ File :01/82/050/00031/AM15/ RLA File :22/24/040/00081/AM14/ Lic.No/Date:2210014589 04.02.2014 Defer Date:11.09.2014 262
Case No.:28/3/82ALC4/2014
Party Name:MEDICEF PHARMA, 24.07.2014 Status:Case Deferred HQ File :01/82/050/00032/AM15/ RLA File :22/24/040/00082/AM14/ Lic.No/Date:2210014588 04.02.2014 Defer Date:11.09.2014 263
Case No.:87/3/82ALC4/2014
24.07.2014 Status:Case Deferred HQ File :01/82/050/00091/AM15/ RLA File :09/24/040/00544/AM14/ Lic.No/Date:0910059155 04.02.2014 Defer Date:11.09.2014 Decision :Decision :It was decided to defer the case 11.09.2014 for comments of Department of Chemicals and Petrochemicals 264
Case No.:117/3/82ALC4/2014
24.07.2014 Status:Case Deferred HQ File :01/82/050/00121/AM15/ RLA File :09/24/040/00543/AM14/ Lic.No/Date:0910059156 04.02.2014 Defer Date:11.09.2014 Decision :Decision :It was decided to defer the case 11.09.2014 for comments of Department of Chemicals and Petrochemicals 265
Case No.:232/3/82ALC4/2014
Party Name:CADILA HEALTHCARE LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00236/AM15/ RLA File :08/24/040/00485/AM14/ Lic.No/Date:0810128700 05.02.2014 Defer Date:11.09.2014
266
Case No.:221/3/82ALC4/2014
Party Name:CIPLA LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00225/AM15/ RLA File :03/94/040/00995/AM14/ Lic.No/Date:0310769240 05.02.2014 Defer Date:11.09.2014 267
Case No.:222/3/82ALC4/2014
Party Name:CIPLA LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00226/AM15/ RLA File :03/94/040/00985/AM14/ Lic.No/Date:0310769244 05.02.2014 Defer Date:11.09.2014 268
Case No.:224/3/82ALC4/2014
Party Name:CIPLA LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00228/AM15/ RLA File :03/94/040/00979/AM14/ Lic.No/Date:0310769253 05.02.2014 Defer Date:11.09.2014 269
Case No.:225/3/82ALC4/2014
Party Name:CIPLA LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00229/AM15/ RLA File :03/94/040/00991/AM14/ Lic.No/Date:0310769247 05.02.2014 Defer Date:11.09.2014 270
Case No.:149/3/82ALC4/2014
Party Name:MOREPEN LABORATORIES LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00153/AM15/ RLA File :05/24/040/00420/AM14/ Lic.No/Date:0510378413 05.02.2014 Defer Date:11.09.2014 271
Case No.:168/3/82ALC4/2014
Party Name:CIPLA LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00172/AM15/ RLA File :03/94/040/01009/AM14/ Lic.No/Date:0310769592 06.02.2014 Defer Date:11.09.2014
272
Case No.:150/3/82ALC4/2014
Party Name:MACLEODS PHARMACEUTICALS LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00154/AM15/ RLA File :03/95/040/00879/AM14/ Lic.No/Date:0310769509 06.02.2014 Defer Date:11.09.2014 273
Case No.:8/3/82ALC4/2014
Party Name:ALEKHYA DRUGS PVT LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00012/AM15/ RLA File :09/24/040/00548/AM14/ Lic.No/Date:0910059218 07.02.2014 Defer Date:11.09.2014 274
Case No.:10/3/82ALC4/2014
Party Name:ARENE LIFE SCIENCES LIMITED. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00014/AM15/ RLA File :09/24/040/00534/AM14/ Lic.No/Date:0910059227 07.02.2014 Defer Date:11.09.2014 275
Case No.:59/3/82ALC4/2014
Party Name:ARENE LIFE SCIENCES LIMITED. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00063/AM15/ RLA File :09/24/040/00551/AM14/ Lic.No/Date:0910059222 07.02.2014 Defer Date:11.09.2014 276
Case No.:49/3/82ALC4/2014
24.07.2014 Status:Case Deferred HQ File :01/82/050/00053/AM15/ RLA File :09/24/040/00562/AM14/ Lic.No/Date:0910059197 07.02.2014 Defer Date:11.09.2014 277
Case No.:151/3/82ALC4/2014
Party Name:CIPLA LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00155/AM15/ RLA File :03/94/040/01022/AM14/ Lic.No/Date:0310769755 07.02.2014 Defer Date:11.09.2014
278
Case No.:211/3/82ALC4/2014
Party Name:DEEPAK NITRITE LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00215/AM15/ RLA File :34/24/040/00201/AM14/ Lic.No/Date:3410039219 07.02.2014 Defer Date:25.09.2014 Decision :Decision :It was decided to defer the case 25.09.2014 for comments of Department of Chemicals and Petrochemicals. 279
Case No.:84/3/82ALC4/2014
Party Name:STERICON PHARMA PVT.LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00088/AM15/ RLA File :07/24/040/00419/AM14/ Lic.No/Date:0710102047 07.02.2014 Defer Date:11.09.2014 280
Case No.:54/3/82ALC4/2014
Party Name:ASTRIX LABORATORIES LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00058/AM15/ RLA File :09/24/040/00552/AM14/ Lic.No/Date:0910059230 10.02.2014 Defer Date:25.09.2014 Decision :Decision :It was decided to defer the case for 25.09.2014 for comments of Department of Pharmaceuticals. 281
Case No.:167/3/82ALC4/2014
Party Name:CIPLA LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00171/AM15/ RLA File :03/94/040/01028/AM14/ Lic.No/Date:0310769983 10.02.2014 Defer Date:25.09.2014 282
Case No.:64/3/82ALC4/2014
Party Name:ARENE LIFE SCIENCES LIMITED. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00068/AM15/ RLA File :09/24/040/00554/AM14/ Lic.No/Date:0910059247 11.02.2014 Defer Date:25.09.2014 283
Case No.:92/3/82ALC4/2014
LIMITED 24.07.2014 Status:Case Approved HQ File :01/82/050/00096/AM15/ RLA File :04/24/040/00244/AM14/ Lic.No/Date:0410155099 11.02.2014 Defer Date: Decision : withdrawn the case has been already approved by the NC in its 3/82 meeting dated 08.05.2014
284
Case No.:46/3/82ALC4/2014
Party Name:ARENE LIFE SCIENCES LIMITED. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00050/AM15/ RLA File :09/24/040/00555/AM14/ Lic.No/Date:0910059260 12.02.2014 Defer Date:25.09.2014 285
Case No.:47/3/82ALC4/2014
Party Name:ARENE LIFE SCIENCES LIMITED. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00051/AM15/ RLA File :09/24/040/00535/AM14/ Lic.No/Date:0910059259 12.02.2014 Defer Date:25.09.2014 286
Case No.:61/3/82ALC4/2014
Party Name:INCHEM LABORATORIES PRIVATE LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00065/AM15/ RLA File :09/24/040/00568/AM14/ Lic.No/Date:0910059258 12.02.2014 Defer Date:25.09.2014 Decision :Decision :It was decided to defer the case for 25.09.2014 for comments of Department of Pharmaceuticals 287
Case No.:113/3/82ALC4/2014
Party Name:RANBAXY LABORATORIES LTD 24.07.2014 Status:Case Deferred HQ File :01/82/050/00117/AM15/ RLA File :05/24/040/00332/AM14/ Lic.No/Date:0510379132 12.02.2014 Defer Date:25.09.2014 288
Case No.:48/3/82ALC4/2014
24.07.2014 Status:Case Deferred HQ File :01/82/050/00052/AM15/ RLA File :09/24/040/00582/AM14/ Lic.No/Date:0910059263 12.02.2014 Defer Date:25.09.2014 Decision :Decision :It was decided to defer the case for 25.09.2014 for comments of Department of C&PC. 289
Case No.:112/3/82ALC4/2014
24.07.2014 Status:Case Deferred HQ File :01/82/050/00116/AM15/ RLA File :09/24/040/00564/AM14/ Lic.No/Date:0910059262 12.02.2014 Defer Date:25.09.2014 Decision :Decision :It was decided to defer the case for 25.09.2014 for comments of Department of C&PC
290
Case No.:205/3/82ALC4/2014
Party Name:FORACE POLYMERS (P) LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00209/AM15/ RLA File :05/23/040/00466/AM14/ Lic.No/Date:0510379284 13.02.2014 Defer Date:24.07.2014 Decision :Decision :It was decided to defer the case for 25.09.2014 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals 291
Case No.:2/3/82ALC4/2014
Party Name:SCOTTEDIL PHARMACIA LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00006/AM15/ RLA File :22/24/040/00089/AM14/ Lic.No/Date:2210014609 13.02.2014 Defer Date:25.09.2014 Decision :Decision :It was decided to defer the case for 25.07.2014 for comments of Department of Pharmaceuticals. 292
Case No.:73/3/82ALC4/2014
Party Name:ARENE LIFE SCIENCES LIMITED. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00077/AM15/ RLA File :09/24/040/00536/AM14/ Lic.No/Date:0910059285 14.02.2014 Defer Date:25.09.2014 293
Case No.:9/3/82ALC4/2014
Party Name:SMILAX LABORATORIES LIMITED Meet No/Date:5/82ALC4/2014 24.07.2014 Status:Case Deferred HQ File :01/82/050/00013/AM15/ RLA File :09/24/040/00584/AM14/ Lic.No/Date:0910059308 14.02.2014 Defer Date:25.09.2014 294
Case No.:29/3/82ALC4/2014
Party Name:R L FINE CHEM 24.07.2014 Status:Case Deferred HQ File :01/82/050/00033/AM15/ RLA File :07/24/040/00422/AM14/ Lic.No/Date:0710102208 17.02.2014 Defer Date:25.09.2014 295 Case No.:130/3/82ALC4/2014 24.07.2014 Status:Case Deferred HQ File :01/82/050/00134/AM15/ RLA File :09/24/040/00587/AM14/ Lic.No/Date:0910059321 18.02.2014 Defer Date:25.09.2014
296
Case No.:242/3/82ALC4/2014
Party Name:CADILA HEALTHCARE LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00246/AM15/ RLA File :08/24/040/00505/AM14/ Lic.No/Date:0810128924 18.02.2014 Defer Date:25.09.2014 Decision :In the light of wri⯒en comments received from Department of Pharmaceu㘐�cals vide their OM No. 35011/466/2013‐PI(Norms) dated 21.11.2013, it was decided to ra㘐�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 Etodolac Extended Release Tablets 400 MG, 500 MG and 600 MG TAB S.NO. Import Items For export of 1 Million Tablets 400 mg 500 mg 600 mg 1 LACTOSE MONOHYDRATE NF/PH 35.5 kg 44.375 kg 86.850 kg 2 MAGNESIUM STEARATE 17.5 21.875 26.250 3 7ETHYL TRYPTOPHOL (76%) 386.376 482.970 579.564 4 METHYL3OXO VALERATE 220.320 275.400 330.480 5 5 to 12 Relevant as per packing policy 297
Case No.:166/3/82ALC4/2014
Party Name:VIJAY PERFUMES PVT.LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00170/AM15/ RLA File :03/95/040/00916/AM14/ Lic.No/Date:0310770668 18.02.2014 Defer Date:25.09.2014 Decision :Decision :It was decided to defer the case for 25.09.2014 for comments of Department of C&PC. 298
Case No.:52/3/82ALC4/2014
Party Name:ALEMBIC PHARMACEUTICALS LTD 24.07.2014 Status:Case Deferred HQ File :01/82/050/00056/AM15/ RLA File :34/24/040/00282/AM14/ Lic.No/Date:3410039321 19.02.2014 Defer Date:25.09.2014 299 Case No.:125/3/82ALC4/2014 24.07.2014 Status:Case Deferred
HQ File :01/82/050/00129/AM15/ RLA File :09/24/040/00570/AM14/ Lic.No/Date:0910059353 19.02.2014 Defer Date:25.09.2014 300
Case No.:47/23/82ALC4/2013
Party Name:PORUS LABORATORIES PVT LTD. 24.07.2014 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:25.09.2014 301
Case No.:216/3/82ALC4/2014
Party Name:SENTISS PHARMA PVT.LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00220/AM15/ RLA File :05/24/040/00431/AM14/ Lic.No/Date:0510379833 19.02.2014 Defer Date:25.09.2014 302
Case No.:86/3/82ALC4/2014
Party Name:AKZO NOBEL INDIA LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00090/AM15/ RLA File :02/24/040/00197/AM14/ Lic.No/Date:0210200380 21.02.2014 Defer Date:25.09.2014 303
Case No.:241/3/82ALC4/2014
Party Name:ATUL LIMITED, 24.07.2014 Status:Case Deferred HQ File :01/82/050/00245/AM15/ RLA File :08/24/040/00483/AM14/ Lic.No/Date:0810129084 21.02.2014 Defer Date:25.09.2014 304
Case No.:15/3/82ALC4/2014
24.07.2014 Status:Case Deferred HQ File :01/82/050/00019/AM15/ RLA File :09/24/040/00598/AM14/ Lic.No/Date:0910059372 21.02.2014 Defer Date:25.09.2014 Decision :Decision :It was decided to defer the case for 25.09.2014 for comments of Department of C&PC. 305 Case No.:16/3/82ALC4/2014 24.07.2014 Status:Case Deferred
HQ File :01/82/050/00020/AM15/ RLA File :09/24/040/00592/AM14/ Lic.No/Date:0910059375 21.02.2014 Defer Date:25.09.2014 306
Case No.:237/3/82ALC4/2014
Party Name:CADILA HEALTHCARE LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00241/AM15/ RLA File :08/24/040/00523/AM14/ Lic.No/Date:0810129092 24.02.2014 Defer Date:25.09.2014 Decision :Decision :It was decided to defer the case for 25.09.2014 for comments of Department of Pharmaceuticals 307
Case No.:105/3/82ALC4/2014
Party Name:THINQ PHARMACRO LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00109/AM15/ RLA File :03/95/040/00842/AM14/ Lic.No/Date:0310771596 24.02.2014 Defer Date:25.09.2014 308
Case No.:161/3/82ALC4/2014
Party Name:UNIMAX CHEMICALS PVT LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00165/AM15/ RLA File :03/95/040/00889/AM14/ Lic.No/Date:0310771527 24.02.2014 Defer Date:25.09.2014 Decision :Decision :It was decided to defer the case for 25.09.2014 for comments of Department of Pharmaceuticals 309
Case No.:233/3/82ALC4/2014
Party Name:CADILA HEALTHCARE LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00237/AM15/ RLA File :08/24/040/00526/AM14/ Lic.No/Date:0810129185 25.02.2014 Defer Date:25.09.2014 Decision :Decision :It was decided to defer the case for 25.09.2014 for comments of Department of Pharmaceuticals 310
Case No.:14/3/82ALC4/2014
Party Name:RA CHEM PHARMA LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00018/AM15/ RLA File :09/24/040/00589/AM14/ Lic.No/Date:0910059417 25.02.2014 Defer Date:25.09.2014 Decision : It was decided to defer the case for 25.09.2014 for comments of Department of Pharmaceuticals 311
Case No.:7/3/82ALC4/2014
24.07.2014 Status:Case Deferred
HQ File :01/82/050/00011/AM15/ RLA File :09/24/040/00604/AM14/ Lic.No/Date:0910059427 26.02.2014 Defer Date:25.09.2014 Decision : It was decided to defer the case for 25.09.2014 for comments of Department of Pharmaceuticals 312
Case No.:5/3/82ALC4/2014
Party Name:INDO PHYTO CHEMICALS PVT LTD 24.07.2014 Status:Case Deferred HQ File :01/82/050/00009/AM15/ RLA File :05/23/040/00494/AM14/ Lic.No/Date:0510380433 27.02.2014 Defer Date:25.09.2014 Decision :Decision :It was decided to defer the case for 25.09.2014 for comments of Department of Pharmaceuticals 313
Case No.:162/3/82ALC4/2014
Party Name:ZIM LABORATORIES LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00166/AM15/ RLA File :03/95/040/00967/AM14/ Lic.No/Date:0310772330 27.02.2014 Defer Date:25.09.2014 Decision :Decision :It was decided to defer the case for 25.09.2014 for comments of Department of Pharmaceuticals 314
Case No.:79/3/82ALC4/2014
Party Name:GLAND PHARMA LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00083/AM15/ RLA File :09/24/040/00610/AM14/ Lic.No/Date:0910059455 28.02.2014 Defer Date:25.09.2014 Decision :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 25.09.2014 315
Case No.:133/3/82ALC4/2014
Party Name:NECTAR LIFESCIENCES LIMITED, 24.07.2014 Status:Case Deferred HQ File :01/82/050/00137/AM15/ RLA File :22/24/040/00096/AM14/ Lic.No/Date:2210014646 28.02.2014 Defer Date:25.09.2014 316
Case No.:106/3/82ALC4/2014
Party Name:PERFECT VITAMINS PVT.LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00110/AM15/ RLA File :03/95/040/00960/AM14/ Lic.No/Date:0310772411 28.02.2014 Defer Date:25.09.2014 Decision :Decision :It was decided to defer the case for 25.09.2014 for comments of Department of Pharmaceuticals 317 Case No.:184/3/82ALC4/2014 Party Name:ARUDAA VIS LABS PRIVATE Status:Case
LIMITED 24.07.2014 Deferred HQ File :01/82/050/00188/AM15/ RLA File :04/24/040/00266/AM14/ Lic.No/Date:0410155776 03.03.2014 Defer Date:25.09.2014 318
Case No.:228/3/82ALC4/2014
Party Name:GOPINATH CHEMTECH LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00232/AM15/ RLA File :08/24/040/00521/AM14/ Lic.No/Date:0810129315 03.03.2014 Defer Date:25.09.2014 Decision :Decision :It was decided to defer the case for 25.09.2014 for comments of Department of C&PC. 319
Case No.:122/3/82ALC4/2014
Party Name:NANDU CHEMICAL INDUSTRIES 24.07.2014 Status:Case Deferred HQ File :01/82/050/00126/AM15/ RLA File :07/24/040/00408/AM14/ Lic.No/Date:0710102530 03.03.2014 Defer Date:25.09.2014 Decision :Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 25.09.2014 320
Case No.:25/3/82ALC4/2014
Party Name:CATAPHARMA CHEMICALS PVT. LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00029/AM15/ RLA File :31/83/040/00207/AM14/ Lic.No/Date:3110062928 04.03.2014 Defer Date:25.09.2014 Decision :Decision :It was decided to call from the firm COA of import item from the foreign supplier for the relevant consignment . The case was deferred for 25.09.2014 321
Case No.:3/3/82ALC4/2014
LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00007/AM15/ RLA File :04/24/040/00258/AM14/ Lic.No/Date:0410156078 11.03.2014 Defer Date:25.09.2014 Decision :Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/633/2013 PI(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 29.09.2014 322 Case No.:6/3/82ALC4/2014 LIMITED 24.07.2014 Status:Case Deferred Lic.No/Date:0410156076
HQ File :01/82/050/00010/AM15/ RLA File :04/24/040/00257/AM14/ 11.03.2014 Defer Date:25.09.2014 Decision :Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/633/2013 PI(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 25.09.2014 323
Case No.:62/3/82ALC4/2014
LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00066/AM15/ RLA File :04/24/040/00259/AM14/ Lic.No/Date:0410156077 11.03.2014 Defer Date:25.09.2014 Decision :Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/633/2013 PI(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 29.09.2014 324
Case No.:231/3/82ALC4/2014
Party Name:SWISS EXPORTS PVT. LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00235/AM15/ RLA File :08/24/040/00537/AM14/ Lic.No/Date:0810129646 13.03.2014 Defer Date:25.09.2014 325
Case No.:13/3/82ALC4/2014
Party Name:INDSWIFT LABORATORIES LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00017/AM15/ RLA File :22/24/040/00101/AM14/ Lic.No/Date:2210014693 14.03.2014 Defer Date:25.09.2014 326 Case No.:24/5/82ALC4/2014 Party Name:R L FINE CHEM 24.07.2014 Status: Approved HQ File :01/82/050/00341/AM15/ RLA File :07/24/040/00471/AM14/ Lic.No/Date:0710102942 17.03.2014 Defer Date: Decision :In the light of earlier decision taken in mee㘐�ng no. 14/82 dated 24.10.2013, it was decided to ra㘐�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 kg/kg CHLORPROMAZINE HCL IP 1 1 BROMO 3 CHLORO PROPANE 0.95 2 2 CHLORO PHENOTHAZINE 0.90
3 ACETONE 3.33 327
Case No.:57/3/82ALC4/2014
Party Name:JUBILANT LIFE SCIENCES LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00061/AM15/ RLA File :05/23/040/00506/AM14/ Lic.No/Date:0510382053 18.03.2014 Defer Date:25.09.2014 328
Case No.:26/5/82ALC4/2014
Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 24.07.2014 Status:Case Added HQ File :01/82/050/00343/AM15/ RLA File :07/24/040/00469/AM14/ Lic.No/Date:0710103055 20.03.2014 Defer Date: Decision : 329
Case No.:123/3/82ALC4/2014
Party Name:JUBILANT LIFE SCIENCES LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00127/AM15/ RLA File :05/23/040/00508/AM14/ Lic.No/Date:0510382292 20.03.2014 Defer Date:25.09.2014 330
Case No.:25/5/82ALC4/2014
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 24.07.2014 Status:Case Deferred HQ File :01/82/050/00342/AM15/ RLA File :07/24/040/00340/AM14/ Lic.No/Date:0710103209 26.03.2014 Defer Date:25.09.2014 331
Case No.:81/5/82ALC4/2014
24.07.2014 Status:Case Deferred HQ File :01/82/050/00398/AM15/ RLA File :03/94/040/01160/AM14/ Lic.No/Date:0310775960 26.03.2014 Defer Date:25.09.2014 Decision :Decision :It was decided to defer the case for 25.05.2014 for comments of Department of Pharmaceuticals. 332 Case No.:82/5/82ALC4/2014 24.07.2014 Status:Case Deferred
HQ File :01/82/050/00399/AM15/ RLA File :03/94/040/01152/AM14/ Lic.No/Date:0310775954 26.03.2014 Defer Date:25.09.2014 333
Case No.:50/5/82ALC4/2014
Party Name:ALTA LABORATORIES LTD. 24.07.2014 Status:Case Approved HQ File :01/82/050/00367/AM15/ RLA File :03/94/040/01075/AM14/ Lic.No/Date:0310776102 27.03.2014 Defer Date: Decision :In the light of earlier decision taken in mee㘐�ng no. 17/82 dated 05.12.2013, it was decided to ra㘐�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 334
Case No.:43/5/82ALC4/2014
Party Name:FINE ORGANIC INDUSTRIES PVT. LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00360/AM15/ RLA File :03/94/040/01145/AM14/ Lic.No/Date:0310776137 27.03.2014 Defer Date:25.09.2014 Decision :It was decided to defer the case for 25.09.2014 for comments of Department of C&PC. 335
Case No.:51/5/82ALC4/2014
Party Name:JINDAL DRUGS LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00368/AM15/ RLA File :03/94/040/01098/AM14/ Lic.No/Date:0310776087 27.03.2014 Defer Date:25.09.2014 336
Case No.:48/5/82ALC4/2014
24.07.2014 Status:Case Deferred HQ File :01/82/050/00365/AM15/ RLA File :03/94/040/01168/AM14/ Lic.No/Date:0310776170 27.03.2014 Defer Date:25.09.2014 337 Case No.:49/5/82ALC4/2014 24.07.2014 Status:Case Deferred HQ File :01/82/050/00366/AM15/ RLA File :03/94/040/01158/AM14/ Lic.No/Date:0310776158 27.03.2014 Defer Date:25.09.2014
338
Case No.:44/5/82ALC4/2014
24.07.2014 Status:Case Deferred HQ File :01/82/050/00361/AM15/ RLA File :03/94/040/01157/AM14/ Lic.No/Date:0310776372 28.03.2014 Defer Date:25.09.2014 339
Case No.:45/5/82ALC4/2014
24.07.2014 Status:Case Deferred HQ File :01/82/050/00362/AM15/ RLA File :03/94/040/01170/AM14/ Lic.No/Date:0310776360 28.03.2014 Defer Date:25.09.2014 340
Case No.:46/5/82ALC4/2014
24.07.2014 Status:Case Deferred HQ File :01/82/050/00363/AM15/ RLA File :03/94/040/01172/AM14/ Lic.No/Date:0310776367 28.03.2014 Defer Date:25.09.2014 341
Case No.:47/5/82ALC4/2014
24.07.2014 Status:Case Deferred HQ File :01/82/050/00364/AM15/ RLA File :03/94/040/01169/AM14/ Lic.No/Date:0310776351 28.03.2014 Defer Date:25.09.2014 342
Case No.:83/5/82ALC4/2014
Party Name:VEGESNA LABORATORIES PRIVATE LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00400/AM15/ RLA File :09/24/040/00666/AM14/ Lic.No/Date:0910059688 01.04.2014 Defer Date:25.09.2014 343 Case No.:73/5/82ALC4/2014 Party Name:ARIHANTANAM LIFECARE PVT. LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00390/AM15/ RLA File :03/94/040/01189/AM14/ Lic.No/Date:0310776770 02.04.2014 Defer Date:25.09.2014
344
Case No.:70/5/82ALC4/2014
Party Name:ASHU ORGANICS (INDIA) PVT. LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00387/AM15/ RLA File :03/94/040/01138/AM14/ Lic.No/Date:0310776777 02.04.2014 Defer Date:25.09.2014 345
Case No.:11/5/82ALC4/2014
Party Name:AROMA AROMATICS & FLAVOURS 24.07.2014 Status:Case Deferred HQ File :01/82/050/00328/AM15/ RLA File :05/23/040/00507/AM14/ Lic.No/Date:0510383624 03.04.2014 Defer Date:25.09.2014 Decision :It was decided to defer the case for 25.05.2014 for comments of Department of C&PC. 346
Case No.:23/5/82ALC4/2014
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 24.07.2014 Status:Case Deferred HQ File :01/82/050/00340/AM15/ RLA File :07/24/040/00484/AM14/ Lic.No/Date:0710103375 03.04.2014 Defer Date:25.09.2014 Decision :It was decided to defer the case for 25.05.2014 for comments of Department of C&PC. 347
Case No.:62/5/82ALC4/2014
Party Name:YASHO INDUSTRIES PVT.LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00379/AM15/ RLA File :03/95/040/00004/AM15/ Lic.No/Date:0310777048 04.04.2014 Defer Date:25.09.2014 Decision :It was decided to defer the case for 25.05.2014 for comments of Department of C&PC. 348
Case No.:75/5/82ALC4/2014
Party Name:GALAXY SURFACTANTS LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00392/AM15/ RLA File :03/94/040/01196/AM14/ Lic.No/Date:0310777284 07.04.2014 Defer Date:25.09.2014 Decision :It was decided to defer the case for 25.05.2014 for comments of Department of C&PC. 349 Case No.:33/5/82ALC4/2014 Party Name:JAINEX SPECIALITY CHEMICAL 24.07.2014 Status:Case Deferred HQ File :01/82/050/00350/AM15/ RLA File :34/24/040/00321/AM14/ Lic.No/Date:3410039746 07.04.2014 Defer Date:25.09.2014
Decision :It was decided to defer the case for 25.05.2014 for comments of Department of C&PC. 350
Case No.:28/5/82ALC4/2014
Party Name:BALAJI AMINES LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00345/AM15/ RLA File :31/83/040/00217/AM14/ Lic.No/Date:3110063437 09.04.2014 Defer Date:25.09.2014 Decision :It was decided to defer the case for 25.05.2014 for comments of Department of C&PC. 351
Case No.:29/5/82ALC4/2014
Party Name:BALAJI AMINES LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00346/AM15/ RLA File :31/83/040/00216/AM14/ Lic.No/Date:3110063438 09.04.2014 Defer Date:25.09.2014 Decision :It was decided to defer the case for 25.05.2014 for comments of Department of C&PC. 352
Case No.:67/5/82ALC4/2014
Party Name:FDC LTD 24.07.2014 Status:Case Deferred HQ File :01/82/050/00384/AM15/ RLA File :03/94/040/00001/AM15/ Lic.No/Date:0310777658 09.04.2014 Defer Date:25.09.2014 353
Case No.:72/5/82ALC4/2014
Party Name:GLOBE TROTTERS PVT LTD 24.07.2014 Status:Case Deferred HQ File :01/82/050/00389/AM15/ RLA File :03/94/040/01100/AM14/ Lic.No/Date:0310777795 09.04.2014 Defer Date:25.09.2014 354
Case No.:79/5/82ALC4/2014
Party Name:AARTI INDUSTRIES LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00396/AM15/ RLA File :03/94/040/00015/AM15/ Lic.No/Date:0310777966 10.04.2014 Defer Date:25.09.2014 355 Case No.:65/5/82ALC4/2014 Party Name:CROWN CHEMICALS PVT.LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00382/AM15/ RLA File :03/94/040/00004/AM15/ Lic.No/Date:0310777887 10.04.2014 Defer Date:25.09.2014
356
Case No.:66/5/82ALC4/2014
Party Name:CROWN CHEMICALS PVT.LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00383/AM15/ RLA File :03/94/040/00005/AM15/ Lic.No/Date:0310777897 10.04.2014 Defer Date:25.09.2014 357
Case No.:32/5/82ALC4/2014
Party Name:EMCURE PHARMACEUTICALS LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00349/AM15/ RLA File :31/83/040/00008/AM15/ Lic.No/Date:3110063481 11.04.2014 Defer Date:25.09.2014 358
Case No.:68/5/82ALC4/2014
Party Name:FDC LTD 24.07.2014 Status:Case Deferred HQ File :01/82/050/00385/AM15/ RLA File :03/94/040/01125/AM14/ Lic.No/Date:0310778140 11.04.2014 Defer Date:25.09.2014 359
Case No.:27/5/82ALC4/2014
Party Name:ALEMBIC PHARMACEUTICALS LTD 24.07.2014 Status:Case Deferred HQ File :01/82/050/00344/AM15/ RLA File :34/24/040/00006/AM15/ Lic.No/Date:3410039801 15.04.2014 Defer Date:25.09.2014 360
Case No.:34/5/82ALC4/2014
Party Name:ALEMBIC PHARMACEUTICALS LTD 24.07.2014 Status:Case Deferred HQ File :01/82/050/00351/AM15/ RLA File :34/24/040/00003/AM15/ Lic.No/Date:3410039800 15.04.2014 Defer Date:25.09.2014 361 Case No.:80/5/82ALC4/2014 Party Name:AARTI INDUSTRIES LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00397/AM15/ RLA File :03/94/040/00027/AM15/ Lic.No/Date:0310778437 16.04.2014 Defer Date:25.09.2014
362
Case No.:30/5/82ALC4/2014
Party Name:PRECISE CHEMIPHARMA PVT.LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00347/AM15/ RLA File :31/83/040/00013/AM15/ Lic.No/Date:3110063517 16.04.2014 Defer Date:25.09.2014 363
Case No.:69/5/82ALC4/2014
Party Name:FDC LTD 24.07.2014 Status:Case Deferred HQ File :01/82/050/00386/AM15/ RLA File :03/94/040/00041/AM15/ Lic.No/Date:0310778812 21.04.2014 Defer Date:25.09.2014 Decision : It was decided to defer the case for 25.09.2014 for comments of Department of Pharmaceuticals. 364
Case No.:31/5/82ALC4/2014
Party Name:GOPINATH CHEMTECH LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00348/AM15/ RLA File :08/24/040/00017/AM15/ Lic.No/Date:0810130717 21.04.2014 Defer Date:25.09.2014 365
Case No.:61/5/82ALC4/2014
Party Name:LITMUS ORGANICS P. LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00378/AM15/ RLA File :03/95/040/00044/AM15/ Lic.No/Date:0310778780 21.04.2014 Defer Date:25.09.2014 366
Case No.:59/5/82ALC4/2014
Party Name:SUNSHIELD CHEMICALS LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00376/AM15/ RLA File :03/95/040/00021/AM15/ Lic.No/Date:0310778745 21.04.2014 Defer Date:25.09.2014 367 Case No.:78/5/82ALC4/2014 Party Name:IPCA LABORATORIES LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00395/AM15/ RLA File :03/94/040/00012/AM15/ Lic.No/Date:0310779054 22.04.2014 Defer Date:25.09.2014
368
Case No.:58/5/82ALC4/2014
Party Name:MICRO ORGOCHEM 24.07.2014 Status:Case Deferred HQ File :01/82/050/00375/AM15/ RLA File :03/95/040/00003/AM15/ Lic.No/Date:0310778885 22.04.2014 Defer Date:25.09.2014 369
Case No.:56/5/82ALC4/2014
Party Name:SHIRDI CHEMICALS PVT. LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00373/AM15/ RLA File :03/95/040/00051/AM15/ Lic.No/Date:0310778879 22.04.2014 Defer Date:25.09.2014 370
Case No.:60/5/82ALC4/2014
Party Name:YASHO INDUSTRIES PVT.LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00377/AM15/ RLA File :03/95/040/00040/AM15/ Lic.No/Date:0310778874 22.04.2014 Defer Date:25.09.2014 371
Case No.:76/5/82ALC4/2014
Party Name:GLENMARK GENERICS LIMITED 24.07.2014 Status:Case Approved HQ File :01/82/050/00393/AM15/ RLA File :03/94/040/00050/AM15/ Lic.No/Date:0310779212 23.04.2014 Defer Date: Decision :Commi⯒ee considered case as per agenda and in light of earlier decision taken in 42/82 mee㘐�ng held on 17.01.2012 and in consulta㘐�on with technical authority present in mee㘐�ng, decided to ra㘐�fy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Linezilid 1 kg 1. Thioace㘐�c Acid 1.77 kg 2. Methylene Chloride/Methylene Dichloride/MDC 10.30 kg 3. R Glycidyl Butyrate 1.07 kg 4. Dimethyl Formamide 4.275 kg 5. Tetrahydrofuran 5.44 kg 6. 3,4‐Difluoronitrobenzene 1.76 kg 7. Methanol 7.75 kg RA concerned may take further necessary ac㘐�on as per above decision of NC
372
Case No.:77/5/82ALC4/2014
Party Name:INDOCO REMEDIES LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00394/AM15/ RLA File :03/94/040/00997/AM14/ Lic.No/Date:0310779207 23.04.2014 Defer Date:25.09.2014 373
Case No.:53/5/82ALC4/2014
Party Name:UNIMAX CHEMICALS PVT LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00370/AM15/ RLA File :03/95/040/00015/AM15/ Lic.No/Date:0310779156 23.04.2014 Defer Date:25.09.2014 374
Case No.:84/5/82ALC4/2014
Party Name:MICRO LABS LTD 24.07.2014 Status:Case Approved HQ File :01/82/050/00401/AM15/ RLA File :07/21/040/00060/AM15/ Lic.No/Date:0710103725 24.04.2014 Defer Date: Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per SION A412 with 2% wastage. RA concerned may take further necessary action as per above decision of NC. 375
Case No.:6/5/82ALC4/2014
Party Name:UNITED BIOTECH PVT.LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00323/AM15/ RLA File :05/24/040/00034/AM15/ Lic.No/Date:0510384810 24.04.2014 Defer Date:25.09.2014 376 Case No.:42/5/82ALC4/2014 Party Name:CIRON DRUGS & PHARMACEUTICALS P. LTD., 24.07.2014 Status:Case Approved HQ File :01/82/050/00359/AM15/ RLA File :03/94/040/00018/AM15/ Lic.No/Date:0310779457 25.04.2014 Defer Date: Decision :Committee considered case as per agenda and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed CANC EYE DROPS 1 No. vial 1. NAcetylCarnosine 0.051 gm per 5 ml
(COMPOSITION GLYCERIN USP 1% W/V, CARBOXY METHYLCELLULOSE USP 0.3%W/V,EXCIPIENTS: BENZYL ALCOHOL USP 0.3% (AS PERSERVATIVE), NACETYL CARNOSINE 1%w/v POTASSIUM BICARBONATE USP QS BORIC ACID NF q.s (2 X5 ML) NET CONTENT : 1)N ACETYLCARNOSINE :9.524 KILOGRAM vial RA may take appropriate action as per the decision of Norms Committee. 377
Case No.:63/5/82ALC4/2014
Party Name:MACLEODS PHARMACEUTICALS LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00380/AM15/ RLA File :03/95/040/00028/AM15/ Lic.No/Date:0310779501 25.04.2014 Defer Date:25.09.2014 378
Case No.:8/5/82ALC4/2014
Party Name:MOREPEN LABORATORIES LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00325/AM15/ RLA File :05/24/040/00016/AM15/ Lic.No/Date:0510384943 25.04.2014 Defer Date:25.09.2014 379
Case No.:7/5/82ALC4/2014
Party Name:S.M. HERBALS PVT.LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00324/AM15/ RLA File :05/24/040/00007/AM15/ Lic.No/Date:0510385061 25.04.2014 Defer Date:25.09.2014 380
Case No.:64/5/82ALC4/2014
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00381/AM15/ RLA File :03/95/040/00026/AM15/ Lic.No/Date:0310779504 25.04.2014 Defer Date:25.09.2014 381 Case No.:55/5/82ALC4/2014 Party Name:O C SPECIALITIES PVT.LTD. 24.07.2014 Status:Case Deferred
HQ File :01/82/050/00372/AM15/ RLA File :03/95/040/00076/AM15/ Lic.No/Date:0310779584 28.04.2014 Defer Date:25.09.2014 382
Case No.:52/5/82ALC4/2014
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00369/AM15/ RLA File :03/95/040/01033/AM14/ Lic.No/Date:0310779872 29.04.2014 Defer Date:25.09.2014 Decision :It was decided to request the firm to furnish their justification for seeking fixation of adhoc norms in respect of above advance authorization where both import and export items are same. 383
Case No.:74/5/82ALC4/2014
Party Name:ARIHANTANAM LIFECARE PVT. LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00391/AM15/ RLA File :03/94/040/00080/AM15/ Lic.No/Date:0310780141 30.04.2014 Defer Date:25.09.2014 384
Case No.:3/5/82ALC4/2014
Party Name:NEW ALLIANCE DYECHEM PVT. LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00320/AM15/ RLA File :03/95/040/00017/AM15/ Lic.No/Date:0310780255 01.05.2014 Defer Date:25.09.2014 385 Case No.:20/5/82ALC4/2014 Party Name:INDO PHYTO CHEMICALS PVT LTD 24.07.2014 Status: Approved HQ File :01/82/050/00337/AM15/ RLA File :05/23/040/00036/AM15/ Lic.No/Date:0510385550 02.05.2014 Defer Date: Decision : In the light of earlier decision taken in mee㘐�ng no. 2/82 dated 18.04.2013, it was decided to ra㘐�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 Quan㘐�ty S.No Import Product Quan㘐�ty Allowed Allylestrenol Bulk Drug 1 kg 1. Sitolactone Intermediate 1.95 kg 2. 5‐Chloro‐2‐pentanone Reagent 1.81 kg 3. Tetrahydroforan Solvent 5.80 kg
386
Case No.:9/5/82ALC4/2014
Party Name:DHANUKA LABORATORIES LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00326/AM15/ RLA File :05/23/040/00041/AM15/ Lic.No/Date:0510385706 05.05.2014 Defer Date:25.09.2014 387
Case No.:12/5/82ALC4/2014
Party Name:DHANUKA LABORATORIES LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00329/AM15/ RLA File :05/23/040/00042/AM15/ Lic.No/Date:0510385707 05.05.2014 Defer Date:25.09.2014 388
Case No.:36/5/82ALC4/2014
Party Name:ENVEE DRUGS PVT LTD 24.07.2014 Status:Case Approved HQ File :01/82/050/00353/AM15/ RLA File :34/24/040/00015/AM15/ Lic.No/Date:3410039935 05.05.2014 Defer Date: Decision :In the light of earlier decision taken in mee㘐�ng no. 3/82 dated 08.05.2014, it was decided to ra㘐�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 Quan㘐�ty S.No Import items Quan㘐�ty Allowed kg/kg Clobetasole Propionate BP/USP 1 kg 1 Betamethasone BP/USP/IP 1.04 389
Case No.:39/5/82ALC4/2014
Party Name:INTAS PHARMACEUTICALS LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00356/AM15/ RLA File :08/24/040/00048/AM15/ Lic.No/Date:0810131081 05.05.2014 Defer Date:25.09.2014 390 Case No.:54/5/82ALC4/2014 Party Name:NEW ALLIANCE DYECHEM PVT. LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00371/AM15/ RLA File :03/95/040/00077/AM15/ Lic.No/Date:0310780621 05.05.2014 Defer Date:25.09.2014
Decision :It was decided to defer the case for 24.09.2014 for comments of Department of C&PC. 391
Case No.:57/5/82ALC4/2014
Party Name:NEW ALLIANCE DYECHEM PVT. LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00374/AM15/ RLA File :03/95/040/00085/AM15/ Lic.No/Date:0310780627 05.05.2014 Defer Date:25.09.2014 392
Case No.:10/5/82ALC4/2014
Party Name:JUBILANT LIFE SCIENCES LIMITED 24.07.2014 Status: Approved HQ File :01/82/050/00327/AM15/ RLA File :05/23/040/00015/AM15/ Lic.No/Date:0510385902 06.05.2014 Defer Date: Decision :In the light of earlier decision taken by NC in its 1/82 mee㘐�ng dated 10.04.2014, it was decided to ra㘐�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: Atovastatin Tablets 5mg and 10 mg S.NO. Import Items For export of 1 No. tablet (Qty in mg) 5 mg 10mg 1. Atorvastatin Calcium 5.42 10.84 2. Microcrystalline Cellulose (PH101) 12.48 8.66 3. Calmellose Calcium (ECG 505) 16.00 20.0 4. Hydroxypropylcellulose (SSL) 0.70 1.0 5. Magnesium Oxide (XP103) 15.0 16.0 6. Magnesium Oxide JP 8.0 30.0 7. Microcrystalline Cellulose (KG 1000) 2.0 ‐‐‐‐ 8. Magnesium stearate 0.40 0.50 9. Methylene Chloride 45.0 61.0 10. Anhydrous Ethanol 5.0 16.0 393
Case No.:71/5/82ALC4/2014
Party Name:ARIHANTANAM LIFECARE PVT. LTD. 24.07.2014 Status:Case Deferred HQ File :01/82/050/00388/AM15/ RLA File :03/94/040/00076/AM15/ Lic.No/Date:0310780901 07.05.2014 Defer Date:25.09.2014
394 Case No.:35/5/82ALC4/2014 Party Name:ELIXIR PHARMA 24.07.2014 Status:Case Deferred HQ File :01/82/050/00352/AM15/ RLA File :08/24/040/00047/AM15/ Lic.No/Date:0810131142 07.05.2014 Defer Date:25.09.2014 395
Case No.:13/5/82ALC4/2014
Party Name:PARABOLIC DRUGS LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00330/AM15/ RLA File :05/24/040/00049/AM15/ Lic.No/Date:0510386137 09.05.2014 Defer Date:25.09.2014 396
Case No.:15/5/82ALC4/2014
Party Name:PARABOLIC DRUGS LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00332/AM15/ RLA File :05/24/040/00036/AM15/ Lic.No/Date:0510386135 09.05.2014 Defer Date:25.09.2014 397
Case No.:21/5/82ALC4/2014
Party Name:PARABOLIC DRUGS LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00338/AM15/ RLA File :05/24/040/00039/AM15/ Lic.No/Date:0510386136 09.05.2014 Defer Date:25.09.2014 398
Case No.:14/5/82ALC4/2014
Party Name:PAYAL PETROCHEM PRIVATE LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00331/AM15/ RLA File :05/24/040/00293/AM14/ Lic.No/Date:0510386127 09.05.2014 Defer Date:25.09.2014 399
Case No.:16/5/82ALC4/2014
Party Name:PAYAL PETROCHEM PRIVATE LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00333/AM15/ RLA File :05/24/040/00443/AM14/ Lic.No/Date:0510386128 09.05.2014 Defer Date:25.09.2014
400 Case No.:17/5/82ALC4/2014 Party Name:RECKITT BENCKISER HEALTHCARE INDIA LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00334/AM15/ RLA File :05/24/040/00053/AM15/ Lic.No/Date:0510386224 09.05.2014 Defer Date:25.09.2014 401
Case No.:18/5/82ALC4/2014
Party Name:RECKITT BENCKISER HEALTHCARE INDIA LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00335/AM15/ RLA File :05/24/040/00021/AM15/ Lic.No/Date:0510386223 09.05.2014 Defer Date:25.09.2014 402
Case No.:19/5/82ALC4/2014
Party Name:RECKITT BENCKISER HEALTHCARE INDIA LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00336/AM15/ RLA File :05/24/040/00020/AM15/ Lic.No/Date:0510386217 09.05.2014 Defer Date:25.09.2014 403
Case No.:37/5/82ALC4/2014
Party Name:ATUL BIOSCIENCE LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00354/AM15/ RLA File :52/24/040/00002/AM15/ Lic.No/Date:5210041051 19.05.2014 Defer Date:25.09.2014 404
Case No.:40/5/82ALC4/2014
Party Name:SHIVAM OILS & PROTEINS INDUSTRY, 24.07.2014 Status:Case Deferred HQ File :01/82/050/00357/AM15/ RLA File :56/24/040/00007/AM15/ Lic.No/Date:5610004192 19.05.2014 Defer Date:25.09.2014 405
Case No.:38/5/82ALC4/2014
Party Name:INTAS PHARMACEUTICALS LTD., 24.07.2014 Status:Case Deferred HQ File :01/82/050/00355/AM15/ RLA File :08/24/040/00076/AM15/ Lic.No/Date:0810131456 20.05.2014 Defer Date:25.09.2014
406 Case No.:22/5/82ALC4/2014 Party Name:STERILE INDIA PRIVATE LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00339/AM15/ RLA File :05/24/040/00040/AM15/ Lic.No/Date:0510387173 22.05.2014 Defer Date:25.09.2014 407
Case No.:41/5/82ALC4/2014
Party Name:ALMELO PVT LTD 24.07.2014 Status:Case Deferred HQ File :01/82/050/00358/AM15/ RLA File :09/24/040/00096/AM15/ Lic.No/Date:0910060207 23.05.2014 Defer Date:25.09.2014 408
Case No.:5/5/82ALC4/2014
24.07.2014 Status:Case Approved HQ File :01/82/050/00322/AM15/ RLA File :09/24/040/00166/AM15/ Lic.No/Date:0910060560 01.07.2014 Defer Date: Decision :The Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/4/2011PI(Norms) dated 28.11.2011 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 Exp. Qty. Sl.No. Import items Qty. allowed Tenofovir Disoproxil Fumarate 1 Kg. 1 Adenine 0.914 kg 2 (R)(+)Propylene Carbonate 0.7938 kg 3 Carbon Enoanticormos ( Activated Carbon ) 0.016 kg 4 Chloromethyl Isopropyl Carbonate 2.0867 kg 5 DiethylpToluenesulfonyloxymethyl Phosphonate 2.025 kg 6 Dimethyl Formamide ( DMF ) 3.404 kg 7 Hydrobromic acid 48% 6.54 kg 8 Isopropyl Acetate 4.498 kg 9 Isopropyl Alcohol 2.765 kg 10 Methane Sulphonic acid 0.1074 kg 11 Methylene Chloride 4.119 kg 12 N Methyl 2 Pyrrolidone 3.297 kg 13 Triethylamine 0.905 kg 14 Steam/Thermal Coal (NonCooking) As per Fuel Policy RA concerned may take further necessary action as per above decision of NC. 409 Case No.:85/5/82ALC4/2014 Party Name:S M S PHARMACEUTICALS LTD Status:Case
24.07.2014 Deferred HQ File :01/82/050/00402/AM15/ RLA File :09/24/040/00185/AM15/ Lic.No/Date:0910060654 11.07.2014 Defer Date:25.09.2014 410
Case No.:7/20/82ALC4/2013
Party Name:HONEST BIOVET PVT. LTD 24.07.2014 Status: Approved HQ File :01/82/050/00993/AM14/ RLA File :08/24/040/00339/AM14/ Lic.No/Date:0810126094 29.10.2013 Defer Date: Decision :In the light of wri⯒en comments received from Department of Pharmaceu㘐�cals vide their OM No. 35011/730/2013‐PI(Norms) dated 21.04.2014, it was decided to ra㘐�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 kg/kg MENADIONE DIMETHYL PYRIMIDINOL BISULPHITE (FEED SUPPLEMENT) 1kg 1. MENADIONE SODIUM BISULPHATE 0.918 2. ACETYL ACETONE 0.40 3. N – BUTANOL 0.40 411
Case No.:91/23/82ALC4/2013
Party Name:INTAS PHARMACEUTICALS LTD., 24.07.2014 Status: Approved HQ File :01/82/050/01138/AM14/ RLA File :08/24/040/00408/AM14/ Lic.No/Date:0810127281 20.12.2013 Defer Date: Decision :.withdrawn the case has been already approved by the NC in its 3/82 meeting dated 08.05.2014 412
Case No.:47/15/82ALC4/2013
Party Name:PI INDUSTRIES LTD., 24.07.2014 Status:Deffered and Reindexed HQ File :01/82/050/00809/AM14/ RLA File :13/24/040/00026/AM14/ Lic.No/Date:1310044452 24.09.2013 Defer Date:25.09.2014 Decision : It was decided to defer the case for 25.09.2014 for comments of Department of C&PC.
413
Case No.:38/15/82ALC4/2013
Party Name:FDC LTD 24.07.2014 Status:Deffered and Reindexed HQ File :01/82/050/00800/AM14/ RLA File :03/94/040/00256/AM14/ Lic.No/Date:0310751024 25.09.2013 Defer Date:25.09.2014 Decision : It was decided to defer the case for 25.09.2014 for comments of Department of Pharmaceuticals. 414
Case No.:6/20/82ALC4/2013
Party Name:ZIM LABORATORIES LTD. 24.07.2014 Status:Deffered and Reindexed HQ File :01/82/050/00992/AM14/ RLA File :03/95/040/00591/AM14/ Lic.No/Date:0310754588 21.10.2013 Defer Date:25.09.2014 Decision : It was decided to defer the case for 25.09.2014 for comments of Department of Pharmaceuticals. 415
Case No.:213/3/82ALC4/2014
Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD 24.07.2014 Status:Deffered and Reindexed HQ File :01/82/050/00217/AM15/ RLA File :34/24/040/00184/AM14/ Lic.No/Date:3410038266 21.10.2013 Defer Date:25.09.2014 Decision : It was decided to defer the case for 25.09.2014 for comments of Department of C&PC. 416
Case No.:28/4/82ALC4/2014
Party Name:S.R.S.PHARMACEUTICALS PVT. LTD. 24.07.2014 Status:Deffered and Re indexed HQ File :01/82/050/00276/AM15/ RLA File :03/95/040/00575/AM14/ Lic.No/Date:0310754848 22.10.2013 Defer Date:25.09.2014 Decision : It was decided to defer the case for 25.09.2014 for comments of Department of Pharmaceuticals. 417
Case No.:46/4/82ALC4/2014
Party Name:ZIM LABORATORIES LTD. 24.07.2014 Status:Deffered and Reindexed HQ File :01/82/050/00294/AM15/ RLA File :03/95/040/00595/AM14/ Lic.No/Date:0310754827 22.10.2013 Defer Date:25.09.2014 Decision : It was decided to defer the case for 25.09.2014 for comments of Department of Pharmaceuticals. 418 Case No.:60/17/82ALC4/2013 Party Name:SHAMSHREE LIFESCIENCES LTD., 24.07.2014 Status:Deffered and Reindexed Lic.No/Date:2210014319
HQ File :01/82/050/00922/AM14/ RLA File :22/24/040/00051/AM14/ 24.10.2013 Defer Date:25.09.2014 Decision : It was decided to defer the case for 25.09.2014 for comments of Department of Pharmaceuticals. 419
Case No.:17/24/82ALC4/2013
Party Name:EYTAN LABS LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/01216/AM14/ RLA File :09/24/040/00355/AM14/ Lic.No/Date:0910057998 24.10.2013 Defer Date:11.09.2014 420
Case No.:1/3/82ALC4/2014
Party Name:EYTAN LABS LIMITED 24.07.2014 Status:Case Deferred HQ File :01/82/050/00005/AM15/ RLA File :09/24/040/00354/AM14/ Lic.No/Date:0910057999 24.10.2013 Defer Date:25.09.2014 421
Case No.:48/4/82ALC4/2014
Party Name:MANGALAM DRUGS & ORGANICS LIMITED 24.07.2014 Status:Deffered and Reindexed HQ File :01/82/050/00296/AM15/ RLA File :03/95/040/00571/AM14/ Lic.No/Date:0310755274 24.10.2013 Defer Date:11.09.2014 422
Case No.:35/24/82ALC4/2013
24.07.2014 Status:Deffered and Reindexed HQ File :01/82/050/01234/AM14/ RLA File :09/24/040/00346/AM14/ Lic.No/Date:0910058043 28.10.2013 Defer Date:11.09.2014 Decision : It was decided to defer the case for 11.09.2014 for comments of Department of Pharmaceuticals 423
Case No.:21/24/82ALC4/2013
Party Name:SIFLON DRUGS 24.07.2014 Status:Deffered and Reindexed HQ File :01/82/050/01220/AM14/ RLA File :09/24/040/00338/AM14/ Lic.No/Date:0910058067 29.10.2013 Defer Date:11.09.2014 Decision : It was decided to defer the case for 11.09.2014 for comments of Department of Pharmaceuticals
Case No.:31/24/82ALC4/2013
Party Name:SIFLON DRUGS Status:Deffered
424 y 24.07.2014 and Reindexed HQ File :01/82/050/01230/AM14/ RLA File :09/24/040/00335/AM14/ Lic.No/Date:0910058070 29.10.2013 Defer Date:11.09.2014 Decision : It was decided to defer the case for 11.09.2014 for comments of Department of Pharmaceuticals 425
Case No.:37/24/82ALC4/2013
Party Name:SIFLON DRUGS 24.07.2014 Status:Deffered and Reindexed HQ File :01/82/050/01236/AM14/ RLA File :09/24/040/00336/AM14/ Lic.No/Date:0910058069 29.10.2013 Defer Date:11.09.2014 Decision : It was decided to defer the case for 11.09.2014 for comments of Department of Pharmaceuticals 426
Case No.:78/23/82ALC4/2013
Party Name:AMI ORGANICS PVT LTD. 24.07.2014 Status:Deffered and Reindexed HQ File :01/82/050/01125/AM14/ RLA File :52/24/040/00031/AM14/ Lic.No/Date:5210040368 31.10.2013 Defer Date:11.09.2014 Decision : It was decided to defer the case for 11.09.2014 for comments of Department of C&PC 427
Case No.:33/24/82ALC4/2013
Party Name:PORUS LABORATORIES PVT LTD. 24.07.2014 Status:Deffered and Reindexed HQ File :01/82/050/01232/AM14/ RLA File :09/24/040/00375/AM14/ Lic.No/Date:0910058093 31.10.2013 Defer Date:11.09.2014 Decision : It was decided to defer the case for 11.09.2014 for comments of Department of C&PC. 428
Case No.:12/24/82ALC4/2013
Party Name:ASTRIX LABORATORIES LTD., 24.07.2014 Status:Deffered and Reindexed HQ File :01/82/050/01211/AM14/ RLA File :09/24/040/00359/AM14/ Lic.No/Date:0910058146 05.11.2013 Defer Date:11.09.2014 Decision : It was decided to defer the case for 11.09.2014 for comments of Department of Pharmaceuticals 429 Case No.:34/24/82ALC4/2013 Party Name:HETERO LABS LIMITED 24.07.2014 Status:Deffered and Reindexed HQ File :01/82/050/01233/AM14/ RLA File :09/24/040/00378/AM14/ Lic.No/Date:0910058148 05.11.2013 Defer Date:11.09.2014
430
Case No.:33/17/82ALC4/2013
Party Name:EMCURE PHARMACEUTICALS LTD. 24.07.2014 Status:Deffered and Reindexed HQ File :01/82/050/00895/AM14/ RLA File :31/83/040/00149/AM14/ Lic.No/Date:3110061033 11.11.2013 Defer Date:11.09.2014 Date:15.07.2014 Place:New Delhi Nirmal Kumar Dy. Director General of Foreign Trade
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