IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2014-07-24

DGFT Committee Minutes

Document text

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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