IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2011-07-05

DGFT Committee Minutes

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Office of Directorate General of Foreign Trade New Delhi 0

Para 4.7 Decision(DRAFT)

MEETING NUMBER : 14/82ALC4/2011 MEETING DATE : 05.07.2011 The Meeting No.14/82 in the year 201112 to consider the cases under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to products falling in Chapter 29 and 30 was held on 05.07.2011 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present: 1. Shri V.K. Tyagi, Dy.I.A, Department of Pharmaceuticals 2. Shri Jasbir Singh, Consultant, Department of C&PC 3. Shri S.S. Bose, Sr. D.O., DIPP 4. Shri D. Dwarkanath, DDG 5. Shri Shyam Lal, FTDO At the outset, minutes of Norms Committee Meeting No.13/82 dated 28.06.2011 were ratified by the Committee.

Case No.B127

M/S Anuh Pharma Ltd. Norms Committee Meeting No.14/12 F.No.01/82/050/01408/AM09/DESIII Meeting Date:05.07.2011 RA F.No.03/94/040/00866/AM09 Adv.Lic.No.0310497908 dated 15.12.2008 Committee considered case as per agenda and observed that the firm was requested to appear for personal hearing to explain their case, but they have sought postponement for 19.07.2011. Accordingly, it was decided to call the firm for personal hearing on 19.07.2011 and defer the case for 19.07.2011.

Case No.B128

M/S Alembic Ltd. F.No.01/82/050/01228/AM08/DESIII RA F.No.34/24/040/00140/AM08 Adv.Lic.No.3410019698 dated 25.09.2007 Committee decided to defer case for 02.08.2011 for comments of Department of Pharmaceuticals.

Case No.B129

M/S Alembic Ltd. F.No.01/82/050/01117/AM08/DESIII RA F.No.34/24/040/00110/AM08 Adv.Lic.No.3410019573 dated 06.09.20047 Committee decided to defer case for 02.08.2011 for comments of Department of Pharmaceuticals.

Case No.B129A

M/S Intas Pharma Ltd. F.No.01/82/050/01420/AM09/DESIII RA F.No.08/24/040/00073/AM10 Adv.Lic.No.0810076754 dated 15.07.2009 Committee decided to defer case for 30.08.2011 for comments of Department of Pharmaceuticals.

Case No.B130

M/S PI Industries Ltd. F.No.01/82/050/01275/AM10/DESIII RA F.No.13/24/040/00023/AM10 Adv.Lic.No.1310030771 dated 16.12.2009 Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.15022/76/2008Ch.II dated 04.07.2011 and in consultation with technical authority present in meeting, decided to amend the description of import item No.3 to read as “Platinum Vanadium Catalyst (1%Pt + 2% V on activated carbon, Water wet LOD 55%75%)” without any other change in the decision taken in 22/82 meeting held on 31.08.2010. RA concerned may take further necessary action as per above decision of NC.

Case No.B131

M/S Yasho Industries Ltd. F.No.01/82/050/01769/AM09/DESIII RA F.No.03/95/040/01002/AM09 Adv.Lic.No.0310513238 dated 25.03.2009 Committee considered case as per agenda and observed that the firm was requested to furnish production and consumption data certified by Central Excise Authority, but the same has not been received and norms can not be revised in absence of required data. It was, therefore, decided to reject the case.

Case No.C26

M/S Shasun Pharmaceuticals Ltd. F.No.01/82/162/00267/AM12/DESIII Committee decided to defer case for 30.08.2011 for comments of Department of Pharmaceuticals.

Case No.C27

M/S Shasun Pharmaceuticals Ltd. F.No.01/82/162/00261/AM12/DESIII Committee decided to defer case for 30.08.2011 for comments of Department of Pharmaceuticals. 1

Case No.:76/42/82ALC4/2007

Party Name:CAPLIN POINT LABORATORIES LTD., Meet No/Date:14/82ALC4/2011 05.07.2011 Status:Case Approved HQ File :01/82/050/00412/AM08/ RLA File :04/24/040/00151/AM08/ Lic.No/Date:0410090415 03.08.2007 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 with 10% wastage.

Case No.:8/7/82ALC4/2009

Party Name:MAKSON INDUSTRIES PVT. LTD. 05.07.2011 Status:Case Deferred HQ File :01/82/050/00079/AM10/ RLA File :03/95/040/00025/AM10/ Lic.No/Date:0310518715 06.05.2009 Defer Date:02.08.2011 Decision :Committee decided to defer case for 02.08.2011 for comments of DC(MSME). 3

Case No.:30/13/82ALC4/2009

Party Name:SHILPA MEDICARE LTD., 05.07.2011 Status:Case Deferred HQ File :01/82/050/00170/AM10/ RLA File :07/24/040/00103/AM10/ Lic.No/Date:0710065349 11.06.2009 Defer Date:02.08.2011 Decision :Committee decided to defer case for 02.08.2011 for comments of Department of Pharmaceuticals. 4

Case No.:7/28/82ALC4/2009

Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/00567/AM10/ RLA File :03/94/040/01121/AM09/ Lic.No/Date:0310524602 17.06.2009 Defer Date:02.08.2011 Decision :Committee decided to forward a copy of application to Department of Biotechnology for their comments. Accordingly, case was deferred for 02.08.2011. 5

Case No.:30/19/82ALC4/2009

Party Name:SURYA PHARMACEUTICAL LTD 05.07.2011 Status:Case Deferred HQ File :01/82/050/00408/AM10/ RLA File :22/24/040/00015/AM10/ Lic.No/Date:2210009018 22.06.2009 Defer Date:30.08.2011 Decision :Committee decided to defer case for 30.08.2011 for comments of Department of Pharmaceuticals. 6

Case No.:74/5/82ALC4/2010

Party Name:CHIRAL BIOSCIENCES LTD., 05.07.2011 Status:Case Deferred HQ File :01/82/050/00108/AM11/ RLA File :09/24/040/00203/AM10/ Lic.No/Date:0910039636 16.10.2009 Defer Date:30.08.2011 Decision : Committee decided to defer case for 30.08.2011 for comments of Department of Pharmaceuticals. 7

Case No.:14/33/82ALC4/2009

Party Name:VIJAYASRI ORGANICS LTD 05.07.2011 Status:Case Deferred HQ File :01/82/050/00642/AM10/ RLA File :09/24/040/00262/AM10/ Lic.No/Date:0910039756 29.10.2009 Defer Date:30.08.2011 8

Case No.:27/34/82ALC4/2009

Party Name:VIVIMED LABS LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/00672/AM10/ RLA File :09/24/040/00310/AM10/ Lic.No/Date:0910039804 05.11.2009 Defer Date:02.08.2011 Decision : Committee decided to defer case for 02.08.2011 for comments of Department of C&PC.

Case No.:14/41/82ALC4/2009

Party Name:RANBAXY LABORATORIES LTD 05.07.2011 Status:Case Deferred

9 HQ File :01/82/050/00849/AM10/ RLA File :05/24/040/00414/AM10/ Lic.No/Date:0510255098 22.12.2009 Defer Date:30.08.2011 10

Case No.:83/46/82ALC4/2009

Party Name:EUROLIFE HEALTHCARE PVT. LTD. Meet No/Date:14/82ALC4/2011 05.07.2011 Status:Case Rejected HQ File :01/82/050/00999/AM10/ RLA File :03/94/040/00805/AM10/ Lic.No/Date:0310552288 23.12.2009 Decision :Withdrawn as the case has already been rejected by NC in 9/82 meeting held on 31.05.2011. 11

Case No.:81/5/82ALC4/2010

Party Name:MATRIX LABORATORIES LTD 05.07.2011 Status:Case Rejected HQ File :01/82/050/00115/AM11/ RLA File :09/24/040/00390/AM10/ Lic.No/Date:0910040690 28.01.2010 Decision : Withdrawn as the case has already been rejected by NC in 9/82 meeting held on 31.05.2011. 12

Case No.:81/9/82ALC4/2010

Party Name:MSN PHARMACHEM PRIVATE LIMITED 05.07.2011 Status:Case Approved HQ File :01/82/050/00296/AM11/ RLA File :09/24/040/00429/AM10/ Lic.No/Date:0910040725 29.01.2010 Decision : Committee considered case as per agenda and in light of written comments of Department of Pharmaceuticals and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Export Qty. Sl.No. Import items Qty. allowed Sitagliptin Phosphate Monohydrate 1 KG. 1. Ethyl Trifluoroacetate 18.26 kg 2. 2,4,5Trifluorophenyl Acetic Acid 4.673 kg 3. Sodium Borohydrate 0.597 kg 4. Acetonitrile 12.50 kg 5. (3Trifluoromethyl)5,6,7,8 Tetrahydro[1,2,4]Triazolo[4,3a] Pyrazine Hydrochloride 3.022 kg 13

Case No.:41/9/82ALC4/2010

Party Name:CIPLA LIMITED 05.07.2011 Status:Case Approved HQ File :01/82/050/00256/AM11/ RLA File :03/94/040/00980/AM10/ Lic.No/Date:0310559358 09.02.2010 Decision :Withdrawn as the case has already been approved by NC in 4/82 meeting held on 26.04.2011. 14

Case No.:49/22/82ALC4/2010

Party Name:ASTRIX LABORATORIES LTD., 05.07.2011 Status:Case Deferred HQ File :01/82/050/00702/AM11/ RLA File :09/24/040/00250/AM10/ Lic.No/Date:0910040873 09.02.2010 Defer Date:23.08.2011 Decision : Committee decided to defer case for 23.08.2011 for comments of Department of Pharmaceuticals.

Case No :44/39/82 ALC4/2010

Party Name:ASTRIX LABORATORIES LTD Meet No/Date:14/82 ALC4/2011 Status:Case Deferred

Case No.:44/39/82ALC4/2010

Party Name:ASTRIX LABORATORIES LTD., 05.07.2011 Status:Case Deferred HQ File :01/82/050/01125/AM11/ RLA File :09/24/040/00301/AM10/ Lic.No/Date:0910040874 09.02.2010 Defer Date:30.08.2011 Decision :Committee decided to defer case for 30.08.2011 for comments of Department of Pharmaceuticals. 16

Case No.:53/5/82ALC4/2010

Party Name:CADILA PHARMACEUTICALS LTD. 05.07.2011 Status:Case Deferred HQ File :01/82/050/00087/AM11/ RLA File :08/24/040/00004/AM11/ Lic.No/Date:0810088011 07.04.2010 Defer Date:23.08.2011 17

Case No.:48/14/82ALC4/2010

Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 05.07.2011 Status:Case Deferred HQ File :01/82/050/00410/AM11/ RLA File :03/94/040/00933/AM10/ Lic.No/Date:0310570355 20.04.2010 Defer Date:30.08.2011 18

Case No.:11/5/82ALC4/2010

Party Name:PARABOLIC DRUGS LTD., 05.07.2011 Status:Case Deferred HQ File :01/82/050/00045/AM11/ RLA File :05/24/040/00017/AM11/ Lic.No/Date:0510262860 22.04.2010 Defer Date:30.08.2011 19

Case No.:20/6/82ALC4/2010

Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 05.07.2011 Status:Case Approved HQ File :01/82/050/00167/AM11/ RLA File :07/24/040/00002/AM11/ Lic.No/Date:0710071273 28.04.2010 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 with 10% wastage. 20

Case No.:56/14/82ALC4/2010

Party Name:MIDAS CARE PHARMACEUTICALS PVT LTD 05.07.2011 Status:Case Deferred HQ File :01/82/050/00418/AM11/ RLA File :03/95/040/00081/AM11/ Lic.No/Date:0310573993 12.05.2010 Defer Date:30.08.2011 21

Case No.:135/9/82ALC4/2010

Party Name:SAINOR LABORATORIES PVT LTD 05.07.2011 Status:Case Deferred HQ File :01/82/050/00350/AM11/ RLA File :09/24/040/00040/AM11/ Lic.No/Date:0910042075 19.05.2010 Defer Date:02.08.2011 Decision :Committee decided to defer case for 19.08.2011 for comments of Department of C&PC.

Case No.:7/26/82ALC4/2010

Party Name:SMILAX LABORATORIES LIMITED 05.07.2011 Status:Case Approved HQ File :01/82/050/00825/AM11/ RLA File :09/24/040/00061/AM11/ Lic.No/Date:0910042109 25.05.2010 Decision :Withdrawn as the case has already been approved by NC in 4/82 meeting held on 26.04.2011. 23

Case No.:62/15/82ALC4/2010

Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHE 05.07.2011 Status:Case Deferred HQ File :01/82/050/00499/AM11/ RLA File :05/23/040/00041/AM11/ Lic.No/Date:0510265059 31.05.2010 Defer Date:23.08.2011 24

Case No.:15/22/82ALC4/2010

Party Name:SUNWAYS LABORATORIES PVT. LTD. 05.07.2011 Status:Case Deferred HQ File :01/82/050/00668/AM11/ RLA File :03/95/040/00140/AM11/ Lic.No/Date:0310576643 31.05.2010 Defer Date:30.08.2011 25

Case No.:10/26/82ALC4/2010

Party Name:VIVIMED LABS LIMITED 05.07.2011 Status:Case Rejected HQ File :01/82/050/00828/AM11/ RLA File :09/24/040/00058/AM11/ Lic.No/Date:0910042154 31.05.2010 Decision :Committee considered case as per agenda and observed that the firm was requested to furnish percentage content of API in the export product, but the same has not been received and norms can not be fixed in absence to required information. Accordingly, it was decided to reject the case. 26

Case No.:77/40/82ALC4/2010

Party Name:SHREE VINAYAKA LIFE SCIENCES PVT LTD. 05.07.2011 Status:Case Approved HQ File :01/82/050/01276/AM11/ RLA File :09/24/040/00512/AM10/ Lic.No/Date:0910042212 02.06.2010 Decision :Withdrawn as the case has already been approved by NC in 2/82 meeting held on 12.04.2011. 27

Case No.:83/40/82ALC4/2010

Party Name:SHREE VINAYAKA LIFE SCIENCES PVT LTD. 05.07.2011 Status:Case Approved HQ File :01/82/050/01282/AM11/ RLA File :09/24/040/00444/AM09/ Lic.No/Date:0910042211 02.06.2010 Decision : Withdrawn as the case has already been approved by NC in 2/82 meeting held on 12.04.2011. 28

Case No.:147/40/82ALC4/2010

Party Name:AUCTUS PHARMA LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/01346/AM11/ RLA File :09/24/040/00072/AM11/ Lic.No/Date:0910042270 07.06.2010 Defer Date:30.08.2011

Case No :34/39/82 ALC4/2010

Party Name:SMILAX LABORATORIES LIMITED Meet No/Date:14/82 ALC4/2011 Status:Case

Case No.:34/39/82ALC4/2010

Party Name:SMILAX LABORATORIES LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/01115/AM11/ RLA File :09/24/040/00089/AM11/ Lic.No/Date:0910042293 10.06.2010 Defer Date:30.08.2011 30

Case No.:71/15/82ALC4/2010

Party Name:NECTAR LIFESCIENCES LIMITED, 05.07.2011 Status:Case Deferred HQ File :01/82/050/00508/AM11/ RLA File :22/24/040/00010/AM11/ Lic.No/Date:2210010065 14.06.2010 Defer Date:30.08.2011 31

Case No.:38/41/82ALC4/2010

Party Name:COVALENT LABORATORIES PRIVATE LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/01386/AM11/ RLA File :09/24/040/00029/AM11/ Lic.No/Date:0910042383 17.06.2010 Defer Date:30.08.2011 32

Case No.:67/41/82ALC4/2010

Party Name:CHIRAL BIOSCIENCES LTD., 05.07.2011 HQ File :01/82/050/01415/AM11/ RLA File :09/24/040/00005/AM11/ Lic.No/Date:0910042381 17.06.2010 33

Case No.:20/15/82ALC4/2010

Party Name:MEDREICH LIMITED 05.07.2011 HQ File :01/82/050/00457/AM11/ RLA File :07/24/040/00072/AM11/ Lic.No/Date:0710072323 18.06.2010 Defer Date:23.08.2011 34

Case No.:79/41/82ALC4/2010

Party Name:EXPO FINE CHEMICAL INDUSTRIES 05.07.2011 HQ File :01/82/050/01427/AM11/ RLA File :24/24/040/00004/AM11/ Lic.No/Date:2410028786 22.06.2010 Defer Date:26.07.2011 Decision : Committee decided to defer case for 26.07.2011 for comments of Department of C&PC. 35

Case No.:5/15/82ALC4/2010

Party Name:SHODHANA LABORATORIES LTD 05.07.2011 Status:Case Deferred HQ File :01/82/050/00442/AM11/ RLA File :09/24/040/00113/AM11/ Lic.No/Date:0910042470 25.06.2010 Defer Date:16.08.2011 Decision : Committee decided to defer case for 16.08.2011 for comments of Department of Pharmaceuticals. 36

Case No.:28/31/82ALC4/2010

Party Name:MATRIX LABORATORIES LTD 05.07.2011 HQ File :01/82/050/00953/AM11/ RLA File :09/24/040/00083/AM11/ Lic.No/Date:0910042514 25 06 2010

25.06.2010 Decision :Committee considered case as per agenda and observed that the firm has given the description of export product to read as Lamivudine (NI)EU Route. It was, therefore, decided to seek a clarification from the firm as to what is the meaning of (NI)EU Route. Accordingly, case was deferred for 30.08.2011. 37

Case No.:51/41/82ALC4/2010

Party Name:MATRIX LABORATORIES LTD 05.07.2011 Status:Case Deferred HQ File :01/82/050/01399/AM11/ RLA File :09/24/040/00091/AM11/ Lic.No/Date:0910042508 25.06.2010 Defer Date:23.08.2011 38

Case No.:29/31/82ALC4/2010

Party Name:MATRIX LABORATORIES LTD 05.07.2011 HQ File :01/82/050/00954/AM11/ RLA File :09/24/040/00082/AM11/ Lic.No/Date:0910042522 28.06.2010 Decision : Committee considered case as per agenda and observed that the firm has given the description of export product to read as Lamivudine (US Route). It was, therefore, decided to seek a clarification from the firm as to what is the meaning of US Route. Accordingly, case was deferred for 30.08.2011. 39

Case No.:12/15/82ALC4/2010

Party Name:MEDREICH LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/00449/AM11/ RLA File :07/24/040/00099/AM11/ Lic.No/Date:0710072561 29.06.2010 Defer Date:23.08.2011 40

Case No.:67/22/82ALC4/2010

Party Name:MADHUKAR HORMONES & STERODIS [P] LTD. 05.07.2011 Status:Case Deferred HQ File :01/82/050/00720/AM11/ RLA File :03/95/040/00210/AM11/ Lic.No/Date:0310581119 29.06.2010 Defer Date:30.08.2011 41

Case No.:78/15/82ALC4/2010

Party Name:ALEMBIC LIMITED 05.07.2011 Status:Case Approved HQ File :01/82/050/00515/AM11/ RLA File :34/24/040/00070/AM11/ Lic.No/Date:3410027389 30.06.2010 Decision :Withdrawn as the case has already been approved by NC in 51/82 meeting held on 22.03.2011. 42

Case No.:49/41/82ALC4/2010

Party Name:INDIAN IMMUNOLOGICALS LTD., 05.07.2011 Status:Case Deferred HQ File :01/82/050/01397/AM11/ RLA File :09/24/040/00004/AM11/ Lic.No/Date:0910042621 06.07.2010 Defer Date:02.08.2011 Decision :Committee considered case as per agenda and in light of EMail dated 07.04.2011 received from Department of Biotechnology, decided to call the firm for personal hearing on 02.08.2011. Accordingly, case was deferred for 02.08.2011. 43

Case No.:11/16/82ALC4/2010

Party Name:ALEMBIC LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/00527/AM11/ RLA File :34/24/040/00077/AM11/ Lic.No/Date:3410027449 07 07 2010 Defer D t 30 08 2011

07.07.2010 Date:30.08.2011 44

Case No.:28/26/82ALC4/2010

Party Name:VASUDHA PHARMA CHEM LTD 05.07.2011 Status:Case Deferred HQ File :01/82/050/00846/AM11/ RLA File :09/24/040/00397/AM10/ Lic.No/Date:0910042652 08.07.2010 Defer Date:30.08.2011 45

Case No.:97/22/82ALC4/2010

Party Name:TONIRA PHARMA LTD, 05.07.2011 Status:Case Deferred HQ File :01/82/050/00750/AM11/ RLA File :34/24/040/00073/AM11/ Lic.No/Date:3410027520 16.07.2010 Defer Date:30.08.2011 46

Case No.:1/18/82ALC4/2010

Party Name:SUPER URECOAT INDUSTRIES 05.07.2011 Status:Case Approved HQ File :01/82/050/00544/AM11/ RLA File :08/24/040/00112/AM11/ Lic.No/Date:0810090597 19.07.2010 Decision :Withdrawn as the case has already been approved by NC in 50/82 meeting held on 15.03.2011. 47

Case No.:42/41/82ALC4/2010

Party Name:GENEX PHARMA 05.07.2011 Status:Case Approved HQ File :01/82/050/01390/AM11/ RLA File :03/94/040/00283/AM11/ Lic.No/Date:0310584078 19.07.2010 Decision :Withdrawn as the case has already been approved by NC in 9/82 meeting held on 31.05.2011. 48

Case No.:122/40/82ALC4/2010

Party Name:SURYA PHARMACEUTICAL LTD 05.07.2011 Status:Case Deferred HQ File :01/82/050/01321/AM11/ RLA File :22/24/040/00025/AM11/ Lic.No/Date:2210010236 03.08.2010 Defer Date:30.08.2011 49

Case No.:6/20/82ALC4/2010

Party Name:VASUDHA PHARMA CHEM LTD 05.07.2011 Status:Case Approved HQ File :01/82/050/00632/AM11/ RLA File :09/24/040/00167/AM11/ Lic.No/Date:0910043026 10.08.2010 Decision :Withdrawn as the case has already been approved by NC in 4/82 meeting held on 26.04.2011.

Case No.:59/41/82ALC4/2010

Party Name:LUPIN LIMITED 05.07.2011 Status:Case Approved HQ File :01/82/050/01407/AM11/ RLA File :03/95/040/00267/AM11/ Lic.No/Date:0310586682 10.08.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/168/2009 PI (Norms) dated 22.02.2010 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

50 ( ) y p g, y p p applied by firm whichever is lower: Export Product Quantity Sl.No. Import items Quantity allowed Rifampicin BP/USP 1 kg 1. Sodium RifaS 0.98 kga 2. Chloroform 0.661 kg 3. Acetic Acid 0.16 kg 4. Piperzine Anhydrous 0.12 kg 5. Methylene Chloride 0.933 kg 6. Isopropyl Alcohol 0.51 kg 7. Dimethyl Formamide 0.75 kg 8. Tert. Butylamine 0.19 kg 9. Acetone 0.832 kg 10. 1Amino4Methyl Piperazine 0.16 kg 51

Case No.:4/21/82ALC4/2010

Party Name:HERBERT BROWN PHARMACEUTICAL & RESEARCH LABS 05.07.2011 Status:Case Deferred HQ File :01/82/050/00642/AM11/ RLA File :03/94/040/00440/AM11/ Lic.No/Date:0310587202 12.08.2010 Defer Date:30.08.2011 Decision :Committee decided to defer case for 30.08.2011 for reply from the firm. 52

Case No.:15/31/82ALC4/2010

Party Name:R L FINE CHEM 05.07.2011 HQ File :01/82/050/00940/AM11/ RLA File :07/24/040/00156/AM11/ Lic.No/Date:0710073569 12.08.2010 53

Case No.:1/22/82ALC4/2010

Party Name:RANBAXY LABORATORIES LTD 05.07.2011 Status:Case Deferred HQ File :01/82/050/00654/AM11/ RLA File :05/24/040/00171/AM11/ Lic.No/Date:0510270699 17.08.2010 Defer Date:23.08.2011 54

Case No.:121/40/82ALC4/2010

Party Name:SAURAV CHEMICALS LTD, 05.07.2011 Status:Case Deferred HQ File :01/82/050/01320/AM11/ RLA File :22/24/040/00030/AM11/ Lic.No/Date:2210010307 18.08.2010 Defer Date:30.08.2011 55

Case No.:13/14/82ALC4/2011

Party Name:INDSWIFT LABORATORIES LTD., 05.07.2011 Status:Case Deferred HQ File :01/82/050/00404/AM12/ RLA File :22/24/040/00037/AM11/ Lic.No/Date:2210010336 25.08.2010 Defer Date:30.08.2011

Case No.:57/41/82ALC4/2010

Party Name:LUPIN LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/01405/AM11/ RLA File :03/95/040/00382/AM11/ Lic.No/Date:0310589551 26.08.2010 Defer Date:23.08.2011 57

Case No.:30/23/82ALC4/2010

Party Name:MEDREICH LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/00798/AM11/ RLA File :07/24/040/00200/AM11/ Lic.No/Date:0710073911 30.08.2010 Defer Date:30.08.2011 58

Case No.:32/23/82ALC4/2010

Party Name:SUVEN LIFE SCIENCES LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/00800/AM11/ RLA File :09/24/040/00211/AM11/ Lic.No/Date:0910043338 31.08.2010 Defer Date:30.08.2011 59

Case No.:9/24/82ALC4/2010

Party Name:RAMPEX LABS PVT. LTD. 05.07.2011 Status:Case Deferred HQ File :01/82/050/00809/AM11/ RLA File :09/24/040/00194/AM11/ Lic.No/Date:0910043391 07.09.2010 Defer Date:30.08.2011 60

Case No.:12/24/82ALC4/2010

Party Name:VHB MEDISCIENCES LTD. 05.07.2011 Status:Case Approved HQ File :01/82/050/00812/AM11/ RLA File :03/95/040/00447/AM11/ Lic.No/Date:0310591500 08.09.2010 Decision :Withdrawn as the case has already been approved by NC in 4/82 meeting held on 26.04.2011. 61

Case No.:2/25/82ALC4/2010

Party Name:CADILA HEALTHCARE LTD., 05.07.2011 Status:Case Approved HQ File :01/82/050/00816/AM11/ RLA File :08/24/040/00169/AM11/ Lic.No/Date:0810092030 09.09.2010 Decision :Withdrawn as the case has already been approved by NC in 51/82 meeting held on 22.03.2011. 62

Case No.:3/25/82ALC4/2010

Party Name:APEX DRUGS & INTERMEDIATES LIMITED 05.07.2011 Status:Case Approved HQ File :01/82/050/00817/AM11/ RLA File :09/70/040/00082/AM11/ Lic.No/Date:0910043460 09.09.2010 Decision : Committee considered the case as per agenda and in light of earlier decision taken in 35/82 meeting held on 24.11.2009 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed Clopidogrel bisulphate 1 kg. 1. Couple amine Hcl 1.05 kg 2 M th l 4 25 k

Methanol 4.25 kg 3. Methylene dichloride 1.03 kg 4. Acetone 1.68 kg 5. Formic acid 0.185 kg 63

Case No.:45/26/82ALC4/2010

Party Name:MEDREICH LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/00863/AM11/ RLA File :07/24/040/00222/AM11/ Lic.No/Date:0710074194 16.09.2010 Defer Date:30.08.2011 64

Case No.:47/26/82ALC4/2010

Party Name:VIRCHOW PETROCHEMICAL PVT LTD. 05.07.2011 Status:Case Approved HQ File :01/82/050/00865/AM11/ RLA File :09/24/040/00120/AM11/ Lic.No/Date:0910043539 17.09.2010 Decision :Withdrawn as the case has already been approved by NC in 5/82 meeting held on 03.05.2011. 65

Case No.:43/31/82ALC4/2010

Party Name:MADHUKAR HORMONES & STERODIS [P] LTD. 05.07.2011 HQ File :01/82/050/00968/AM11/ RLA File :03/95/040/00341/AM11/ Lic.No/Date:0310593360 22.09.2010 66

Case No.:20/39/82ALC4/2010

Party Name:MADHUKAR HORMONES & STERODIS [P] LTD. 05.07.2011 Status:Case Deferred HQ File :01/82/050/01101/AM11/ RLA File :03/95/040/00321/AM11/ Lic.No/Date:0310593366 22.09.2010 Defer Date:23.08.2011 67

Case No.:70/40/82ALC4/2010

Party Name:INDSWIFT LABORATORIES LTD., 05.07.2011 Status:Case Deferred HQ File :01/82/050/01269/AM11/ RLA File :22/24/040/00042/AM11/ Lic.No/Date:2210010445 24.09.2010 Defer Date:30.08.2011 68

Case No.:5/28/82ALC4/2010

Party Name:ANUS LABORATORIES LTD., 05.07.2011 Status:Case Deferred HQ File :01/82/050/00887/AM11/ RLA File :09/24/040/00137/AM11/ Lic.No/Date:0910043673 28.09.2010 Defer Date:30.08.2011 69

Case No.:141/40/82ALC4/2010

Party Name:PERKIN LABORATORIES 05.07.2011 Status:Case Deferred HQ File 01/82/050/01340/AM11/ RLA File 09/24/040/00406/AM10/ Lic No/Date 0910043680 Defer

69 HQ File :01/82/050/01340/AM11/ RLA File :09/24/040/00406/AM10/ Lic.No/Date:0910043680 28.09.2010 Defer Date:30.08.2011 70

Case No.:23/28/82ALC4/2010

Party Name:ANDHRA ORGANICS LIMITED 05.07.2011 Status:Case Approved HQ File :01/82/050/00905/AM11/ RLA File :09/24/040/00233/AM11/ Lic.No/Date:0910043787 01.10.2010 Decision :Withdrawn as the case has already been approved by NC in 3/82 meeting held on 19.04.2011. 71

Case No.:9/29/82ALC4/2010

Party Name:AUROBINDO PHARMA LIMITED 05.07.2011 HQ File :01/82/050/00919/AM11/ RLA File :09/24/040/00255/AM11/ Lic.No/Date:0910043812 06.10.2010 72

Case No.:54/41/82ALC4/2010

Party Name:GLAND PHARMA LIMITED 05.07.2011 HQ File :01/82/050/01402/AM11/ RLA File :09/24/040/00289/AM11/ Lic.No/Date:0910043863 08.10.2010 73

Case No.:55/41/82ALC4/2010

Party Name:GLAND PHARMA LIMITED 05.07.2011 HQ File :01/82/050/01403/AM11/ RLA File :09/24/040/00298/AM11/ Lic.No/Date:0910043877 11.10.2010 74

Case No.:80/41/82ALC4/2010

Party Name:CHIRAG ENTERPRISE 05.07.2011 Status:Case Deferred HQ File :01/82/050/01428/AM11/ RLA File :24/24/040/00009/AM11/ Lic.No/Date:2410029974 27.10.2010 Defer Date:26.07.2011 Decision :Committee decided to remind the firm to furnish the required technical information. Accordingly, case was deferred for 26.07.2011. 75

Case No.:5/33/82ALC4/2010

Party Name:FORACE POLYMERS (P) LTD. 05.07.2011 Status:Case Approved HQ File :01/82/050/00999/AM11/ RLA File :05/23/040/00201/AM11/ Lic.No/Date:0510276254 03.11.2010 Decision :Withdrawn as the case has already been approved by NC in 5/82 meeting held on 03.05.2011. 76

Case No.:7/33/82ALC4/2010

Party Name:BLISS GVS PHARMA LTD. 05.07.2011 Status:Case Approved HQ File :01/82/050/01001/AM11/ RLA File :03/94/040/00708/AM11/ Lic.No/Date:0310600070 03.11.2010 Decision : Withdrawn as the case has already been approved by NC in 51/82 meeting held on 22.03.2011.

Case No.:9/33/82ALC4/2010

Party Name:DR REDDYS LABORATORIES LTD 05.07.2011 HQ File :01/82/050/01003/AM11/ RLA File :09/24/040/00321/AM11/ Lic.No/Date:0910044180 04.11.2010 78

Case No.:11/33/82ALC4/2010

Party Name:RANBAXY LABORATORIES LTD 05.07.2011 Status:Case Deferred HQ File :01/82/050/01005/AM11/ RLA File :05/24/040/00274/AM11/ Lic.No/Date:0510276395 04.11.2010 Defer Date:23.08.2011 79

Case No.:91/41/82ALC4/2010

Party Name:SOFTGEL HEALTH CARE PVT. LTD., 05.07.2011 Status:Case Approved HQ File :01/82/050/01439/AM11/ RLA File :04/24/040/00206/AM11/ Lic.No/Date:0410118692 08.11.2010 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. 80

Case No.:2/34/82ALC4/2010

Party Name:ALEMBIC LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/01008/AM11/ RLA File :34/24/040/00207/AM11/ Lic.No/Date:3410028544 09.11.2010 Defer Date:30.08.2011 81

Case No.:3/40/82ALC4/2010

Party Name:PADMINI AROMATICS PVT. LTD 05.07.2011 Status:Case Approved HQ File :01/82/050/01202/AM11/ RLA File :07/24/040/00316/AM11/ Lic.No/Date:0710075478 18.11.2010 Decision :Withdrawn as the case has already been approved by NC in 7/82 meeting held on 17.05.2011. 82

Case No.:59/40/82ALC4/2010

Party Name:MEDCHL CHEMICALS AND PHARMACEUTICALS PVT LTD 05.07.2011 Status:Case Deferred HQ File :01/82/050/01258/AM11/ RLA File :09/24/040/00324/AM11/ Lic.No/Date:0910044428 24.11.2010 Defer Date:30.08.2011 Decision :Committee decided to defer case for 30.08.2011 for comments of Department of Pharmaceuticals. 83

Case No.:76/41/82ALC4/2010

Party Name:ESTEEM INDUSTRIES PVT. LTD, 05.07.2011 Status:Case Approved HQ File :01/82/050/01424/AM11/ RLA File :17/24/040/00085/AM09/ Lic.No/Date:1710003597 07.12.2010 Decision :Withdrawn as the case has already been approved by NC in 13/82 meeting held on 28.06.2011.

Case No.:82/41/82ALC4/2010

Party Name:METROPOLITAN EXIMCHEM LTD. 05.07.2011 HQ File :01/82/050/01430/AM11/ RLA File :03/95/040/00674/AM11/ Lic.No/Date:0310604838 07.12.2010 Decision : Withdrawn as the case has already been approved by NC in 9/82 meeting held on 31.05.2011. 85

Case No.:81/41/82ALC4/2010

Party Name:IPCA LABORATORIES LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/01429/AM11/ RLA File :03/94/040/00723/AM11/ Lic.No/Date:0310605141 08.12.2010 Defer Date:23.08.2011 86

Case No.:73/41/82ALC4/2010

Party Name:GOPINATH CHEMTECH LTD., 05.07.2011 Status:Case Approved HQ File :01/82/050/01421/AM11/ RLA File :08/24/040/00270/AM11/ Lic.No/Date:0810094594 13.12.2010 Decision : Withdrawn as the case has already been approved by NC in 1/82 meeting held on 05.04.2011. 87

Case No.:77/41/82ALC4/2010

Party Name:BLISS GVS PHARMA LTD. 05.07.2011 Status:Case Approved HQ File :01/82/050/01425/AM11/ RLA File :03/94/040/00836/AM11/ Lic.No/Date:0310605981 13.12.2010 Defer Date: Decision : Withdrawn as the case has already been approved by NC in 51/82 meeting held on 22.03.2011. 88

Case No.:64/40/82ALC4/2010

Party Name:AUROBINDO PHARMA LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/01263/AM11/ RLA File :09/24/040/00416/AM11/ Lic.No/Date:0910044737 16.12.2010 Defer Date:30.08.2011 89

Case No.:3/41/82ALC4/2010

Party Name:ESTEEM INDUSTRIES PVT. LTD, 05.07.2011 Status:Case Approved HQ File :01/82/050/01351/AM11/ RLA File :17/24/040/00034/AM10/ Lic.No/Date:1710003639 22.12.2010 Decision : Withdrawn as the case has already been approved by NC in 5/82 meeting held on 03.05.2011. 90

Case No.:4/41/82ALC4/2010

Party Name:ESTEEM INDUSTRIES PVT. LTD, 05.07.2011 Status:Case Approved HQ File :01/82/050/01352/AM11/ RLA File :17/24/040/00014/AM11/ Lic.No/Date:1710003640 22.12.2010 Decision : Withdrawn as the case has already been approved by NC in 5/82 meeting held on 03.05.2011. 91

Case No.:5/41/82ALC4/2010

Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 05 07 2011

PHARMACEUTICALS LTD 05.07.2011 HQ File :01/82/050/01353/AM11/ RLA File :09/24/040/00415/AM11/ Lic.No/Date:0910044855 22.12.2010 92

Case No.:18/41/82ALC4/2010

Party Name:ESTEEM INDUSTRIES PVT. LTD, 05.07.2011 HQ File :01/82/050/01366/AM11/ RLA File :17/24/040/00148/AM08/ Lic.No/Date:1710003645 23.12.2010 Decision : Withdrawn as the case has already been approved by NC in 9/82 meeting held on 31.05.2011. 93

Case No.:10/41/82ALC4/2010

Party Name:AARTI ORGANIC 05.07.2011 HQ File :01/82/050/01358/AM11/ RLA File :08/24/040/00286/AM11/ Lic.No/Date:0810094954 27.12.2010 Defer Date:26.07.2011 Decision :Committee decided to remind the firm to furnish the required technical information. Accordingly, case was deferred for 26.07.2011. 94

Case No.:12/41/82ALC4/2010

Party Name:RANBAXY LABORATORIES LTD 05.07.2011 Status:Case Deferred HQ File :01/82/050/01360/AM11/ RLA File :05/24/040/00323/AM11/ Lic.No/Date:0510280422 27.12.2010 Defer Date:23.08.2011 95

Case No.:14/41/82ALC4/2010

Party Name:ANDHRA ORGANICS LIMITED 05.07.2011 Status:Case Approved HQ File :01/82/050/01362/AM11/ RLA File :09/24/040/00405/AM11/ Lic.No/Date:0910044913 27.12.2010 Decision : Withdrawn as the case has already been approved by NC in 3/82 meeting held on 19.04.2011. 96

Case No.:15/41/82ALC4/2010

Party Name:ANDHRA ORGANICS LIMITED 05.07.2011 HQ File :01/82/050/01363/AM11/ RLA File :09/24/040/00379/AM11/ Lic.No/Date:0910044914 27.12.2010 Decision : Withdrawn as the case has already been approved by NC in 3/82 meeting held on 19.04.2011. 97

Case No.:30/41/82ALC4/2010

Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 05.07.2011 Status:Case Deferred HQ File :01/82/050/01378/AM11/ RLA File :05/23/040/00270/AM11/ Lic.No/Date:0510280724 30.12.2010 Defer Date:23.08.2011 Decision :Committee decided to forward a copy of application to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 23.08.2011. 98

Case No.:97/41/82ALC4/2010

Party Name:ESTEEM INDUSTRIES PVT. LTD, 05.07.2011 Status:Case Approved HQ File :01/82/050/01445/AM11/ RLA File :17/24/040/00020/AM11/ Lic.No/Date:1710003665 30.12.2010

Decision : Withdrawn as the case has already been approved by NC in 9/82 meeting held on 31.05.2011. 99

Case No.:33/41/82ALC4/2010

Party Name:AUROBINDO PHARMA LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/01381/AM11/ RLA File :09/24/040/00447/AM11/ Lic.No/Date:0910044965 31.12.2010 Defer Date:30.08.2011 100

Case No.:98/41/82ALC4/2010

Party Name:ESTEEM INDUSTRIES PVT. LTD, 05.07.2011 Status:Case Approved HQ File :01/82/050/01446/AM11/ RLA File :17/24/040/00005/AM09/ Lic.No/Date:1710003673 31.12.2010 Decision : Withdrawn as the case has already been approved by NC in 5/82 meeting held on 03.05.2011. 101

Case No.:99/41/82ALC4/2010

Party Name:ESTEEM INDUSTRIES PVT. LTD, 05.07.2011 Status:Case Approved HQ File :01/82/050/01447/AM11/ RLA File :17/24/040/00093/AM09/ Lic.No/Date:1710003677 31.12.2010 Decision : Withdrawn as the case has already been approved by NC in 5/82 meeting held on 03.05.2011. 102

Case No.:10/42/82ALC4/2010

Party Name:TRIGON CHEMICALS PVT. LTD. 05.07.2011 Status:Case Deferred HQ File :01/82/050/01457/AM11/ RLA File :31/24/040/00179/AM11/ Lic.No/Date:3110046350 10.01.2011 Defer Date:02.08.2011 103

Case No.:11/42/82ALC4/2010

Party Name:SOFTGEL HEALTH CARE PVT. LTD., 05.07.2011 Status:Case Approved HQ File :01/82/050/01458/AM11/ RLA File :04/24/040/00274/AM11/ Lic.No/Date:0410120514 10.01.2011 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. 104

Case No.:12/42/82ALC4/2010

Party Name:SMILAX LABORATORIES LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/01459/AM11/ RLA File :09/24/040/00423/AM11/ Lic.No/Date:0910045104 11.01.2011 Defer Date:30.08.2011 105

Case No.:14/42/82ALC4/2010

Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 05.07.2011 Status:Case Deferred HQ File :01/82/050/01461/AM11/ RLA File :05/24/040/00334/AM11/ Lic.No/Date:0510281231 11.01.2011 Defer Date:30.08.2011

106

Case No.:44/48/82ALC4/2010

Party Name:NECTAR LIFESCIENCES LIMITED, 05.07.2011 HQ File :01/82/050/01687/AM11/ RLA File :22/24/040/00082/AM11/ Lic.No/Date:2210010840 12.01.2011 107

Case No.:22/6/82ALC4/2011

Party Name:HERBOCHEM 05.07.2011 HQ File :01/82/050/00140/AM12/ RLA File :09/24/040/00469/AM11/ Lic.No/Date:0910045206 19.01.2011 Defer Date:19.07.2011 Decision :Committee decided to defer case for 19.07.2011 for comments of DC(MSME). 108

Case No.:27/6/82ALC4/2011

Party Name:DR REDDYS LABORATORIES LTD 05.07.2011 Status:Case Deferred HQ File :01/82/050/00145/AM12/ RLA File :09/24/040/00466/AM11/ Lic.No/Date:0910045215 20.01.2011 Defer Date:30.08.2011 109

Case No.:3/45/82ALC4/2010

Party Name:MEDREICH LIMITED 05.07.2011 HQ File :01/82/050/01543/AM11/ RLA File :07/24/040/00433/AM11/ Lic.No/Date:0710076954 27.01.2011 Decision : Withdrawn as the case has already been approved by NC in 51/82 meeting held on 22.03.2011. 110

Case No.:23/6/82ALC4/2011

Party Name:MATRIX LABORATORIES LTD 05.07.2011 Status:Case Deferred HQ File :01/82/050/00141/AM12/ RLA File :09/24/040/00484/AM11/ Lic.No/Date:0910045232 27.01.2011 Defer Date:30.08.2011 111

Case No.:26/6/82ALC4/2011

Party Name:AUCTUS PHARMA LIMITED 05.07.2011 Status:Case Approved HQ File :01/82/050/00144/AM12/ RLA File :09/24/040/00446/AM11/ Lic.No/Date:0910045268 27.01.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 39/82 meeting held on 28.12.2010 and in consultation with technical authority present in meeting, decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed Rifaximin 1kg. 1. RifamycinO 1.52 kg 2. 2Amino4Picoline 0.43 kg 3. Methanol 2.56 kg

112

Case No.:7/45/82ALC4/2010

Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 05.07.2011 HQ File :01/82/050/01547/AM11/ RLA File :03/95/040/00836/AM11/ Lic.No/Date:0310612992 28.01.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/81/2005/Ch.II dated 01.07.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed 4 Fluorobenzyl Amine (Assay 99%) 1kg. 1. 4 Fluoro Toluene (PFT) 1.1 kg 2. 4 Fluoro Benzaldehyde (ALD4) 1.24 kg 113

Case No.:8/45/82ALC4/2010

Party Name:SIDDHI VINAYAKA SPECHEM PVT.LTD., 05.07.2011 Status:Case Deferred HQ File :01/82/050/01548/AM11/ RLA File :07/24/040/00386/AM11/ Lic.No/Date:0710076995 28.01.2011 Defer Date:26.07.2011 Decision :Committee considered case as per agenda and noted that Department of C&PC vide their letter No.14010/10/2006Ch.II dated 10.03.2011, have called from the firm production and consumption data certified by CA, but the same has not been received. It was, therefore, decided to remind the firm to furnish the same. Accordingly, the case was deferred for 26.07.2011. 114

Case No.:12/45/82ALC4/2010

Party Name:DR REDDYS LABORATORIES LTD 05.07.2011 HQ File :01/82/050/01552/AM11/ RLA File :09/24/040/00482/AM11/ Lic.No/Date:0910045338 31.01.2011 Decision : Withdrawn as the case has already been approved by NC in 9/82 meeting held on 31.05.2011. 115

Case No.:14/45/82ALC4/2010

Party Name:RANBAXY LABORATORIES LTD 05.07.2011 Status:Case Deferred HQ File :01/82/050/01554/AM11/ RLA File :05/24/040/00349/AM11/ Lic.No/Date:0510282602 31.01.2011 Defer Date:30.08.2011 116

Case No.:32/48/82ALC4/2010

Party Name:DR. SABHARWALS WOUND CARE 05.07.2011 Status:Case Deferred HQ File :01/82/050/01675/AM11/ RLA File :06/24/040/00057/AM11/ Lic.No/Date:0610020786 01.02.2011 Defer Date:02.08.2011 Decision : Committee decided to defer case for 02.08.2011 for comments of DIPP.

Case No.:5/48/82ALC4/2010

Party Name:ALKYL AMINES CHEMICALS LTD 05.07.2011 Status:Case Approved HQ File :01/82/050/01648/AM11/ RLA File :03/94/040/00428/AM10/ Lic.No/Date:0310615980 14.02.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/27/2009Ch.II dated 30.06.2011 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

117 y p g y p p pp y whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed 3(2Ethoxy Hexoxy) Propylamine 1kg. 1. Acrylonitrile 0.375 kg 2. 2Ethyl Hexanol 0.813 kg 3. Nickel Catalyst 0.013 kg 4. Methanol 0.265 kg 118

Case No.:6/48/82ALC4/2010

Party Name:ALKYL AMINES CHEMICALS LTD 05.07.2011 HQ File :01/82/050/01649/AM11/ RLA File :03/94/040/00124/AM10/ Lic.No/Date:0310615982 14.02.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/27/2009Ch.II dated 08.06.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed 2 Ethyl Hexylamine 1kg. 1. 2 Ethyl Hexanol 1.06 kg Note: Methanol has no role to play and hence not allowed. 119

Case No.:47/48/82ALC4/2010

Party Name:VIVIMED LABS LIMITED 05.07.2011 Status:Case Rejected HQ File :01/82/050/01690/AM11/ RLA File :09/24/040/00420/AM11/ Lic.No/Date:0910045587 18.02.2011 Decision : Committee considered case as per agenda and observed that the firm was requested to furnish percentage content of API in the export product, but the same has not been received and norms can not be fixed in absence to required information. Accordingly, it was decided to reject the case. 120

Case No.:49/48/82ALC4/2010

Party Name:AUROBINDO PHARMA LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/01692/AM11/ RLA File :09/24/040/00540/AM11/ Lic.No/Date:0910045594 18.02.2011 Defer Date:30.08.2011 121

Case No.:50/48/82ALC4/2010

Party Name:SVR LABORATORIES PRIVATE LIMITED 05.07.2011 HQ File :01/82/050/01693/AM11/ RLA File :09/24/040/00523/AM11/ Lic.No/Date:0910045599 18.02.2011

Case No.:52/48/82ALC4/2010

Party Name:ANSHUL SPECIALTY MOLECULES LTD 05.07.2011

122 HQ File :01/82/050/01695/AM11/ RLA File :03/94/040/00976/AM11/ Lic.No/Date:0310616939 21.02.2011 Defer Date:02.08.2011 123

Case No.:53/48/82ALC4/2010

Party Name:ANSHUL SPECIALTY MOLECULES LTD 05.07.2011 HQ File :01/82/050/01696/AM11/ RLA File :03/94/040/00978/AM11/ Lic.No/Date:0310616944 21.02.2011 124

Case No.:54/48/82ALC4/2010

Party Name:RANBAXY LABORATORIES LTD 05.07.2011 HQ File :01/82/050/01697/AM11/ RLA File :05/24/040/00368/AM11/ Lic.No/Date:0510284434 22.02.2011 125

Case No.:58/48/82ALC4/2010

Party Name:MANNAN POLYMERS 05.07.2011 HQ File :01/82/050/01701/AM11/ RLA File :24/24/040/00018/AM11/ Lic.No/Date:2410030958 22.02.2011 Decision :Committee considered case as per agenda and in light of letter No.46011/41/2011PC.II dated 03.05.2011 issued to the firm by Department of C&PC, Petrochemicals Division, decided to remind the firm to furnish the following information: 1. Technical specifications, %age purity of Regenerated Methyl Methacrylate Monomer to be exported alongwith copy of export order. 2. Detailed manufacturing process alongwith technical justification for wastages/yield at each stage of manufacturing process and also on each of the raw materials. 3. Material balance indicating input and output material at each stage of distillation/manufacturing process. 4. Details of Regenerated Methyl Methacrylate Monomer under reference to be exported and corresponding consumption of all the raw materials (both imported and indigenous) during the last three years duly certified by CA. If the production has not commenced in the past, details from commencement of production may be furnished duly certified by CA. 5. Any other relevant information. Accordingly, case was deferred for 126

Case No.:65/48/82ALC4/2010

Party Name:EMAMI LIMITED, 05.07.2011 HQ File :01/82/050/01708/AM11/ RLA File :02/24/040/00202/AM11/ Lic.No/Date:0210155350 24.02.2011 Decision :Committee decided to defer case for 07.06.2011 for comments of DC(MSME). 127

Case No.:70/48/82ALC4/2010

Party Name:ALKALOIDS CORPORATION 05.07.2011 HQ File :01/82/050/01713/AM11/ RLA File :02/24/040/00209/AM11/ Lic.No/Date:0210155399 25.02.2011

Case No.:73/48/82ALC4/2010

Party Name:SUVEN LIFE SCIENCES

128 LIMITED 05.07.2011 HQ File :01/82/050/01716/AM11/ RLA File :09/24/040/00535/AM11/ Lic.No/Date:0910045717 25.02.2011 129

Case No.:9/6/82ALC4/2011

Party Name:GOPALDAS VISRAM & CO.LTD. Meet No/Date:14/82ALC4/2011 05.07.2011 HQ File :01/82/050/00127/AM12/ RLA File :03/94/040/01040/AM11/ Lic.No/Date:0310618766 01.03.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 51/82 meeting held on 22.03.2011 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 the firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed FunbactA Cream 30 mg Tube 1. Clotrimazole USP 0.306 gm/30 gm Tube 2. Neomycin Sulphate USP 0.153 gm/30 gm Tube RA concerned may take further necessary action as per above decision of Norms. 130

Case No.:4/52/82ALC4/2010

Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 05.07.2011 Status:Case Approved HQ File :01/82/050/01773/AM11/ RLA File :09/24/040/00556/AM11/ Lic.No/Date:0910045892 11.03.2011 Decision : Withdrawn as the case has already been approved by NC in 13/82 meeting held on 28.06.2011. 131

Case No.:3/6/82ALC4/2011

Party Name:AARTI INDUSTRIES LIMITED 05.07.2011 HQ File :01/82/050/00121/AM12/ RLA File :03/94/040/01068/AM11/ Lic.No/Date:0310620821 11.03.2011 132

Case No.:7/6/82ALC4/2011

Party Name:GOPALDAS VISRAM & CO.LTD. 05.07.2011 Status:Case Approved HQ File :01/82/050/00125/AM12/ RLA File :03/94/040/01090/AM11/ Lic.No/Date:0310620712 11.03.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 51/82 meeting held on 22.03.2011 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 the firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed FunbactA Cream 30 mg Tube 1. Clotrimazole USP 0.306 gm/30 gm Tube 2. Neomycin Sulphate USP 0.153 gm/30 gm Tube RA concerned may take further necessary action as per above decision of Norms.

133

Case No.:29/6/82ALC4/2011

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 05.07.2011 HQ File :01/82/050/00147/AM12/ RLA File :03/94/040/01046/AM11/ Lic.No/Date:0310621245 15.03.2011 Decision : Committee decided to forward a copy of application to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 30.08.2011. 134

Case No.:18/52/82ALC4/2010

Party Name:ALKYL AMINES CHEMICALS LTD 05.07.2011 HQ File :01/82/050/01787/AM11/ RLA File :03/94/040/00471/AM11/ Lic.No/Date:0310621836 17.03.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/27/2009Ch.II dated 08.06.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed 2(2Aminoethoxy) Ethanol (Aldega 105) 1kg. 1. Diethylene Glycol 1.12 kg 135

Case No.:4/6/82ALC4/2011

Party Name:ARCH PHARMALABS LTD 05.07.2011 HQ File :01/82/050/00122/AM12/ RLA File :03/94/040/00947/AM11/ Lic.No/Date:0310621827 17.03.2011 136

Case No.:2/6/82ALC4/2011

Party Name:AARTI INDUSTRIES LIMITED 05.07.2011 HQ File :01/82/050/00120/AM12/ RLA File :03/94/040/01113/AM11/ Lic.No/Date:0310622223 21.03.2011 137

Case No.:5/6/82ALC4/2011

Party Name:CIPLA LIMITED 05.07.2011 HQ File :01/82/050/00123/AM12/ RLA File :03/94/040/01132/AM11/ Lic.No/Date:0310622881 23.03.2011 Decision : Committee decided to remind Ministry of Environment and Forests for their NOC/comments. Accordingly, case was deferred for 30.08.2011. 138

Case No.:28/6/82ALC4/2011

Party Name:EXCEL INDUSTRIES LIMITED 05.07.2011 HQ File :01/82/050/00146/AM12/ RLA File :03/94/040/00781/AM11/ Lic.No/Date:0310623267 25.03.2011

Case No.:37/6/82ALC4/2011

Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 05.07.2011

139 HQ File :01/82/050/00155/AM12/ RLA File :05/24/040/00437/AM11/ Lic.No/Date:0510286990 28.03.2011 140

Case No.:19/6/82ALC4/2011

Party Name:SHALINA LABORATORIES PVT. LTD. 05.07.2011 HQ File :01/82/050/00137/AM12/ RLA File :03/95/040/01014/AM11/ Lic.No/Date:0310624194 30.03.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 18/82 meeting held on 29.07.2008 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import item Qty. allowed Germol Antiseptic Liquid (50 ml pack) [each 100ml contain Chloroxylenol BP 4.896% W/V inclusive of 2% wastage] 1 No. 1. Chloroxylenol 2.448 gm/50 ml bottle Germol Antiseptic Liquid (100 ml pack) [each 100ml contain Chloroxylenol BP 4.896% W/V inclusive of 2% wastage] 1 No. 1. Chloroxylenol 4.896 gm/100 ml bottle Germol Antiseptic Liquid (250 ml pack) [each 100ml contain Chloroxylenol BP 4.896% W/V inclusive of 2% wastage] 1 No. 1. Chloroxylenol 12.24 gm/250 ml bottle Germol Antiseptic Liquid (500 ml pack) [each 100ml contain Chloroxylenol BP 4.896% W/V inclusive of 2% wastage] 1 No. 1. Chloroxylenol 24.48 gm/500 ml bottle Germol Antiseptic Liquid (1000 ml pack) [each 100ml contain Chloroxylenol BP 4.896% W/V inclusive of 2% wastage] 1 No. 1. Chloroxylenol 48.96 gm/1000 ml bottle 141

Case No.:30/6/82ALC4/2011

Party Name:CIPLA LIMITED 05.07.2011 HQ File :01/82/050/00148/AM12/ RLA File :03/94/040/01160/AM11/ Lic.No/Date:0310624368 30.03.2011 Decision : Committee considered case as per agenda and observed that Ministry of Environment and Forests (Ozone Cell) have given their No Objection Certificate for import of Zephex 134a (1,1,1,2 Tetrafluoroethane) (HFA 134A Propolen) vide their O.M. No.11/10/2011OC dated 18.05.2011. It was, therefore, in light of earlier decision taken in 52/82 meeting held on 23.03.2010 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed Aerobud 100mcg Inhaler 1 No. 1. Budenoside 0.02 gm.

e obud 00 cg a e (200MD) with 50mcl Aerosol Valve (Budenoside inhaler 100mcg (200MD)) with 50 mcl Aerosol Valve) o ude os de 0 0 g 2. Aerosol Valves 50mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. 0.5 mm OD Acuators with dust covers/caps fitting to 19ml Aluminium Can As per packing policy 5. Zephex 134 A (1,1,1,2 Tetrafluoro ethane)(HFA 134 A Propellant) 14.4 gm. Aerobud 200mcg Inhaler (200MD) with 50mcl Aerosol 200mcg (200MD)) with 50 mcl Aerosol Valve) 1 No. 1. Budenoside 0.04 gm. 2. Aerosol Valves 50mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 14.4 gm. Aerobud 100mcg Inhaler (200MD) with 58mcl Aerosol 100mcg (200MD)) with 58 mcl Aerosol Valve) 1 No. 1. Budenoside 0.02 gm. 2. Aerosol Valves 58mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 18.2 gm. (200MD) with 58mcl Aerosol 200mcg (200MD)) with 58 mcl Aerosol Valve) 1 No. 1. Budenoside 0.04 gm. 2. Aerosol Valves 58mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 18.2 gm. (200MD) with 63mcl Aerosol 200mcg (200MD)) with 63 mcl Aerosol Valve (Contains Zephex 134 A & Ethanol) 1 No. 1. Budenoside 0.04 gm. 2. Aerosol Valves 63 mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 15.5 gm. 6. Ethanol 2.73 gm. Aerobud 100mcg Inhaler (300MD) with 40mcl Aerosol 1 No. 1. Budenoside 0.03 gm. 2. Aerosol Valves 40mcl As per packing policy

100mcg (300MD)) with 40 mcl Aerosol Valve) 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 17.0 gm. (300MD) with 40mcl Aerosol 200mcg (300MD)) with 40 mcl Aerosol Valve) 1 No. 1. Budenoside 0.06 gm. 2. Aerosol Valves 40mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 17.0 gm. Salbutamol 100mcg Inhaler (200MD) with 50mcl Aerosol Valve (Asthavent 100 mcg inhaler (200MD)) with 50 mcl Aerosol Valve) 1 No. 1. Salbutamol 0.02 gm. 2. Aerosol Valves 50mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 14.4 gm. Salbutamol 100mcg Inhaler (200MD) with 58mcl Aerosol Valve (Asthavent 100 mcg inhaler (200MD)) with 58 mcl Aerosol Valve) 1 No. 1. Salbutamol 0.02 gm. 2. Aerosol Valves 58mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 18.2 gm. Salbutamol 300mcg Inhaler (300MD) with 40mcl Aerosol Valve (Asthavent 100 mcg inhaler (300MD)) with 40 mcl Aerosol Valve) 1 No. 1. Salbutamol 0.03 gm. 2. Aerosol Valves 40mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 17.00 gm. Beclate 50mcg Inhaler Valve (Beclomethasone Dipropionate50 mcg inhaler (200MD)) with 63 mcl Aerosol Valve) 1 No. 1. Beclomethasone Dipropionate 0.01 gm. 2. Aerosol Valves 63mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. / fitti t 19 l As per packing li

Aluminium Can policy 5. 17.74 gm. 6. Ethanol 0.455 gm. Beclate 100mcg Inhaler Dipropionate100 mcg inhaler (200MD)) with 63 mcl Aerosol Valve) 1 No. 1. 0.02 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 17.30 gm. 6. Ethanol 0.91 gm. Beclate 200mcg Inhaler Dipropionate200 mcg inhaler (200MD)) with 63 mcl Aerosol Valve) 1 No. 1. 0.04 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 16.4 gm. 6. Ethanol 1.82 gm. Beclate 250mcg Inhaler Dipropionate250 mcg inhaler (200MD)) with 63 mcl Aerosol Valve) 1 No. 1. 0.05 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 15.9 gm. 6. Ethanol 2.27 gm. The above norms have been ratified by NC subject to the following conditions: The quantity of HFA 134A Propellant Gas in the above norms is inclusive of 20% overages to compensate leakage, priming and non retrieval dose remaining inside the Can and and allowance for shot weight variation. However no wastage is claimed for APIs by the firm. The firm will maintain a separate record for the actual consumption of HFA 134A Propellant Gas and will pay duty on the surplus quantity of gas remained unutilized, if any. 142

Case No.:17/6/82ALC4/2011

Party Name:TRIGON ANTIOXIDANTS PVT. LTD, 05.07.2011 Status:Case Deferred HQ File :01/82/050/00135/AM12/ RLA File :03/95/040/01026/AM11/ Lic.No/Date:0310624764 01.04.2011 Defer Date:02.08.2011

143

Case No.:11/6/82ALC4/2011

Party Name:UNI WORLD PHARMA PVT LTD Meet No/Date:14/82ALC4/2011 05.07.2011 HQ File :01/82/050/00129/AM12/ RLA File :03/95/040/00005/AM12/ Lic.No/Date:0310625122 05.04.2011 Decision : Committee considered case as per agenda and observed that Ministry of Environment and Forests (Ozone Cell) have given their No Objection Certificate for import of Zephex 134a (1,1,1,2 Tetrafluoroethane) (HFA 134A Propolen) vide their O.M. No.11/10/2011OC dated 24.06.2011. It was, therefore, in light of earlier decision taken in 52/82 meeting held on 23.03.2010 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed Aerobud 100mcg Inhaler (200MD) with 50mcl Aerosol 100mcg (200MD)) with 50 mcl Aerosol Valve) 1 No. 1. Budenoside 0.02 gm. 2. Aerosol Valves 50mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 14.4 gm. (200MD) with 50mcl Aerosol 200mcg (200MD)) with 50 mcl Aerosol Valve) 1 No. 1. Budenoside 0.04 gm. 2. Aerosol Valves 50mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 14.4 gm. Aerobud 100mcg Inhaler (200MD) with 58mcl Aerosol 100mcg (200MD)) with 58 mcl Aerosol Valve) 1 No. 1. Budenoside 0.02 gm. 2. Aerosol Valves 58mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 18.2 gm. (200MD) with 58mcl Aerosol 200mcg (200MD)) with 58 mcl Aerosol Valve) 1 No. 1. Budenoside 0.04 gm. 2. Aerosol Valves 58mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 18.2 gm. A b d 200 I h l 1 N 1 B d id 0 04

200mcg (200MD)) with 63 mcl Aerosol Valve (Contains Zephex 134 A & Ethanol) 1 No. 1. Budenoside 0.04 gm. 2. Aerosol Valves 63 mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 15.5 gm. 6. Ethanol 2.73 gm. Aerobud 100mcg Inhaler (300MD) with 40mcl Aerosol 100mcg (300MD)) with 40 mcl Aerosol Valve) 1 No. 1. Budenoside 0.03 gm. 2. Aerosol Valves 40mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 17.0 gm. (300MD) with 40mcl Aerosol 200mcg (300MD)) with 40 mcl Aerosol Valve) 1 No. 1. Budenoside 0.06 gm. 2. Aerosol Valves 40mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 17.0 gm. Salbutamol 100mcg Inhaler (200MD) with 50mcl Aerosol Valve (Asthavent 100 mcg inhaler (200MD)) with 50 mcl Aerosol Valve) 1 No. 1. Salbutamol 0.02 gm. 2. Aerosol Valves 50mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 14.4 gm. Salbutamol 100mcg Inhaler (200MD) with 58mcl Aerosol Valve (Asthavent 100 mcg inhaler (200MD)) with 58 mcl Aerosol Valve) 1 No. 1. Salbutamol 0.02 gm. 2. Aerosol Valves 58mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 18.2 gm. Salbutamol 300mcg Inhaler (300MD) with 40mcl Aerosol Valve (Asthavent 100 mcg 1 No. 1. Salbutamol 0.03 gm. 2. Aerosol Valves 40mcl As per packing policy

Valve (Asthavent 100 mcg inhaler (300MD)) with 40 mcl Aerosol Valve) policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 17.00 gm. Beclate 50mcg Inhaler Dipropionate50 mcg inhaler (200MD)) with 63 mcl Aerosol Valve) 1 No. 1. 0.01 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 17.74 gm. 6. Ethanol 0.455 gm. Beclate 100mcg Inhaler Dipropionate100 mcg inhaler (200MD)) with 63 mcl Aerosol Valve) 1 No. 1. 0.02 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 17.30 gm. 6. Ethanol 0.91 gm. Beclate 200mcg Inhaler Dipropionate200 mcg inhaler (200MD)) with 63 mcl Aerosol Valve) 1 No. 1. 0.04 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 16.4 gm. 6. Ethanol 1.82 gm. Beclate 250mcg Inhaler Dipropionate250 mcg inhaler (200MD)) with 63 mcl Aerosol Valve) 1 No. 1. 0.05 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. Aluminium Can As per packing policy 5. 15.9 gm. 6. Ethanol 2.27 gm. The above norms have been ratified by NC subject to the following conditions:

The above norms have been ratified by NC subject to the following conditions: The quantity of HFA 134A Propellant Gas in the above norms is inclusive of 20% overages to compensate leakage, priming and non retrieval dose remaining inside the Can and and allowance for shot weight variation. However no wastage is claimed for APIs by the firm. The firm will maintain a separate record for the actual consumption of HFA 134A Propellant Gas and will pay duty on the surplus quantity of gas remained unutilized, if any. 144

Case No.:18/6/82ALC4/2011

Party Name:MOHINI ORGANICS PVT. LTD., 05.07.2011 Status:Case Approved HQ File :01/82/050/00136/AM12/ RLA File :03/95/040/01029/AM11/ Lic.No/Date:0310625084 05.04.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/80/2010Ch.II dated 04.07.2011 and in consultation with technical authorities present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm Export product Exp. Qty. Sl.No. Import items Qty. allowed Multifunctional High Molecular Weight Complex Fatty Acid Ester (Condensed Product of Pentaerythritol with Adipic Acid and Stearic Acid) 1 Kg. 1. Pentaerythritol 0.150 kg 2. Adipic Acid 0.106 kg 3. Stearic Acid 0.819 kg 145

Case No.:41/14/82ALC4/2011

Party Name:VIVIMED LABS LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/00432/AM12/ RLA File :09/24/040/00609/AM11/ Lic.No/Date:0910046267 05.04.2011 Defer Date:02.08.2011 Decision :Committee decided to defer case for 02.08.2011 for comments of Department of C&PC. 146

Case No.:16/4/82ALC4/2011

Party Name:ALKYL AMINES CHEMICALS LTD 05.07.2011 HQ File :01/82/050/00067/AM12/ RLA File :03/94/040/00646/AM11/ Lic.No/Date:0310625305 06.04.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/27/2009Ch.II dated 30.06.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed NEthyl1,2Dimethylpropylamine 1kg. 1. Methyl Isopropyl Ketone 0.830 kg 147

Case No.:17/4/82ALC4/2011

Party Name:ALKYL AMINES CHEMICALS LTD 05.07.2011 Status:Case Approved HQ File :01/82/050/00068/AM12/ RLA File :03/94/040/00616/AM11/ Lic.No/Date:0310625317 06.04.2011

Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/27/2009Ch.II dated 30.06.2011 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 Export product Export Qty. Sl.No. Import items Qty. allowed Furfurylamine 1kg. 1. Furfuraldehyde 1.164 kg 2. Methanol 0.200 kg 148

Case No.:47/10/82ALC4/2011

Party Name:INDO AMINES LIMITED 05.07.2011 HQ File :01/82/050/00306/AM12/ RLA File :03/94/040/00990/AM11/ Lic.No/Date:0310625341 06.04.2011 Decision :Committee decided to defer case for 02.08.2011 for comments of Department of C&PC. 149

Case No.:38/6/82ALC4/2011

Party Name:SUPREEM PHARMACEUTICALS MYSORE PVT LTD. 05.07.2011 HQ File :01/82/050/00156/AM12/ RLA File :07/24/040/00521/AM11/ Lic.No/Date:0710078544 08.04.2011 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 allowing 1% wastage. 150

Case No.:14/6/82ALC4/2011

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 05.07.2011 HQ File :01/82/050/00132/AM12/ RLA File :07/24/040/00003/AM12/ Lic.No/Date:0710078566 13.04.2011 Defer Date:19.07.2011 Decision : Committee decided to defer case for 19.07.2011 for comments of Department of C&PC. 151

Case No.:1/5/82ALC4/2011

Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 05.07.2011 Status:Case Approved HQ File :01/82/050/00103/AM12/ RLA File :03/94/040/00029/AM12/ Lic.No/Date:0310626724 15.04.2011 Decision: Withdrawn as the case has already been approved by NC in 13/82 meeting held on 28.06.2011. 152

Case No.:4/5/82ALC4/2011

Party Name:HERBOCHEM 05.07.2011 HQ File :01/82/050/00106/AM12/ RLA File :09/24/040/00576/AM11/ Lic.No/Date:0910046396 15.04.2011 Defer Date:19.07.2011 Decision : Committee decided to defer case for 19.07.2011 for comments of DC(MSME). 153

Case No.:49/10/82ALC4/2011

Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 05.07.2011 HQ File :01/82/050/00308/AM12/ RLA File :03/94/040/00028/AM12/ Lic.No/Date:0310626747 15.04.2011

Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/14/2005Ch.II dated 04.07.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed Hexyl Salicylate 1kg. 1. nHexanol 0.511 kg 2. Methyl Salicylate 0.760 kg 154

Case No.:5/5/82ALC4/2011

Party Name:S.R.S.PHARMACEUTICALS PVT. LTD. 05.07.2011 Status:Case Approved HQ File :01/82/050/00107/AM12/ RLA File :03/95/040/00828/AM11/ Lic.No/Date:0310626928 18.04.2011 Decision :Withdrawn as the case has already been approved by NC in 13/82 meeting held on 28.06.2011. 155

Case No.:6/5/82ALC4/2011

Party Name:VIVIMED LABS LIMITED 05.07.2011 HQ File :01/82/050/00108/AM12/ RLA File :09/24/040/00004/AM12/ Lic.No/Date:0910046405 18.04.2011 Defer Date:26.07.2011 Decision :Committee decided to defer case for 26.07.2011 for comments of Department of Pharmaceuticals. 156

Case No.:7/5/82ALC4/2011

Party Name:NEULAND LABORATORIES LTD 05.07.2011 HQ File :01/82/050/00109/AM12/ RLA File :09/24/040/00561/AM11/ Lic.No/Date:0910046412 19.04.2011 157

Case No.:5/14/82ALC4/2011

Party Name:IPCA LABORATORIES LIMITED 05.07.2011 Status:Case Approved HQ File :01/82/050/00396/AM12/ RLA File :03/94/040/00950/AM11/ Lic.No/Date:0310627259 19.04.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 7/11 meeting held on 18.05.2010 and in consultation with technical authority present in meeting, decided to revise 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 Metoprolol Succinate 1 Kg. 1. Para Methoxy Ethyl Phenol 0.7955 kg 2. Epichlorohydrine 0.6179 kg 3. Succinic Acid 0.4508 kg 4. Mono Isopropyl Amine 0.6285 kg 158

Case No.:8/5/82ALC4/2011

Party Name:PROMED EXPORTS PVT.LTD. 05.07.2011 Status:Case Approved HQ File :01/82/050/00110/AM12/ RLA File :05/24/040/00003/AM12/ Lic.No/Date:0510288385 20 04 2011 :

20.04.2011 Decision : Withdrawn as the case has already been approved by NC in 13/82 meeting held on 28.06.2011. 159

Case No.:9/5/82ALC4/2011

Party Name:KLJ PLASTICIZERS LTD, 05.07.2011 Status:Case Approved HQ File :01/82/050/00111/AM12/ RLA File :05/23/040/00012/AM12/ Lic.No/Date:0510288426 20.04.2011 Decision : Withdrawn as the case has already been approved by NC in 13/82 meeting held on 28.06.2011. 160

Case No.:10/5/82ALC4/2011

05.07.2011 HQ File :01/82/050/00112/AM12/ RLA File :05/23/040/00007/AM12/ Lic.No/Date:0510288427 20.04.2011 Decision :Committee decided to forward a copy of application to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 23.08.2011. 161

Case No.:11/5/82ALC4/2011

05.07.2011 HQ File :01/82/050/00113/AM12/ RLA File :05/23/040/00008/AM12/ Lic.No/Date:0510288428 20.04.2011 Decision : Committee decided to forward a copy of application to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 23.08.2011. 162

Case No.:12/5/82ALC4/2011

05.07.2011 HQ File :01/82/050/00114/AM12/ RLA File :05/23/040/00026/AM12/ Lic.No/Date:0510288429 20.04.2011 Decision : Committee decided to forward a copy of application to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 23.08.2011. 163

Case No.:13/5/82ALC4/2011

Party Name:EMBIO LTD 05.07.2011 HQ File :01/82/050/00115/AM12/ RLA File :03/94/040/00009/AM12/ Lic.No/Date:0310627428 20.04.2011 164

Case No.:14/5/82ALC4/2011

Party Name:EMBIO LTD 05.07.2011 Status:Case Deferred HQ File :01/82/050/00116/AM12/ RLA File :03/94/040/00008/AM12/ Lic.No/Date:0310627429 20.04.2011 Defer Date:23.08.2011 165

Case No.:37/10/82ALC4/2011

Party Name:ESTEEM INDUSTRIES PVT. LTD, 05.07.2011 HQ File :01/82/050/00296/AM12/ RLA File :17/24/040/00084/AM09/ Lic.No/Date:1710003962 20.04.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/13/2011Ch.II dated 02.07.2011 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

y p g y p p pp y Export product Exp.Qty S.No. Item of import Qty. allowed Product PE17 R (Oxirane, Methyl, Polymer with Oxirane) (Molecular weight 2170) 1 kg 1. Ethylene Oxide (colourless clear liquid) 0.243 kg 2. Propylene Oxide (Colourless liquid) 0.695 kg 166

Case No.:31/6/82ALC4/2011

Party Name:AUROBINDO PHARMA LIMITED 05.07.2011 HQ File :01/82/050/00149/AM12/ RLA File :09/24/040/00044/AM12/ Lic.No/Date:0910046438 21.04.2011 167

Case No.:32/6/82ALC4/2011

Party Name:AUROBINDO PHARMA LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/00150/AM12/ RLA File :09/24/040/00037/AM12/ Lic.No/Date:0910046439 21.04.2011 Defer Date:30.08.2011 168

Case No.:33/6/82ALC4/2011

Party Name:AUROBINDO PHARMA LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/00151/AM12/ RLA File :09/24/040/00031/AM12/ Lic.No/Date:0910046440 21.04.2011 Defer Date:30.08.2011 169

Case No.:34/6/82ALC4/2011

Party Name:DALAS BIOTECH LTD. 05.07.2011 Status:Case Deferred HQ File :01/82/050/00152/AM12/ RLA File :05/23/040/00025/AM12/ Lic.No/Date:0510288517 21.04.2011 Defer Date:30.08.2011 170

Case No.:24/10/82ALC4/2011

Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD 05.07.2011 HQ File :01/82/050/00283/AM12/ RLA File :34/24/040/00007/AM12/ Lic.No/Date:3410029987 21.04.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/37/2011Ch.II dated 14.06.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed Methoxy Methyl Triphenyl Phosphonium Chloride 1kg. 1. Triphenyl Phosphine 98% 0.806 kg 2 Methylal 99% 0233 kg

Phosphonium Chloride 2. Methylal 99% 0233 kg 171

Case No.:35/6/82ALC4/2011

Party Name:PARABOLIC DRUGS LTD., 05.07.2011 Status:Case Deferred HQ File :01/82/050/00153/AM12/ RLA File :05/24/040/00001/AM12/ Lic.No/Date:0510288662 25.04.2011 Defer Date:30.08.2011 172

Case No.:23/10/82ALC4/2011

Party Name:GULBRANDSEN CHEMICALS PVT LTD 05.07.2011 HQ File :01/82/050/00282/AM12/ RLA File :34/24/040/00009/AM12/ Lic.No/Date:3410029995 25.04.2011 Decision :Committee decided to defer case for 02.08.2011 for comments of Department of C&PC. 173

Case No.:39/6/82ALC4/2011

Party Name:SATYADEVA PHARMACEUTICALS /P/ LTD., 05.07.2011 Status:Case Deferred HQ File :01/82/050/00157/AM12/ RLA File :09/24/040/00622/AM11/ Lic.No/Date:0910046495 26.04.2011 Defer Date:30.08.2011 174

Case No.:20/14/82ALC4/2011

Party Name:ADCOCK INGRAM LTD, 05.07.2011 Status:Case Approved HQ File :01/82/050/00411/AM12/ RLA File :07/24/040/00021/AM12/ Lic.No/Date:0710078772 26.04.2011 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. 175

Case No.:32/14/82ALC4/2011

Party Name:AUROBINDO PHARMA LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/00423/AM12/ RLA File :09/24/040/00605/AM11/ Lic.No/Date:0910046500 26.04.2011 Defer Date:30.08.2011 Decision :Committee decided to defer case for 30.08.2011 for comments of Department of Pharmaceuticals. 176

Case No.:41/6/82ALC4/2011

Party Name:SATYAM PHARMA CHEM PVT LTD 05.07.2011 HQ File :01/82/050/00159/AM12/ RLA File :03/95/040/01046/AM11/ Lic.No/Date:0310628344 27.04.2011

Case No.:43/6/82ALC4/2011

Party Name:POLYDRUG LABORATORIES PVT.LTD. 05.07.2011 HQ File :01/82/050/00162/AM12/ RLA File :03/95/040/00048/AM12/ Lic.No/Date:0310628588 28 04 2011

177 28.04.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 3/82 meeting held on 20.04.2010 and in consultation with technical authority present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed Ferrous Fumarate 1 Kg. 1. Fumaric Acid 0.769 kg 178

Case No.:44/6/82ALC4/2011

Party Name:SUVEN LIFE SCIENCES LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/00163/AM12/ RLA File :09/24/040/00038/AM12/ Lic.No/Date:0910046559 28.04.2011 Defer Date:30.08.2011 Decision :Committee decided to defer case for 30.08.2011 for comments of Department of Pharmaceuticals. 179

Case No.:45/6/82ALC4/2011

Party Name:RA CHEM PHARMA LIMITED 05.07.2011 HQ File :01/82/050/00164/AM12/ RLA File :09/24/040/00024/AM12/ Lic.No/Date:0910046561 28.04.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 52/82 meeting held on 23.03.2010 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 2(2,3Dichlorophenyl) Methylene Hydazine Carboximidamidine 1 Kg. 1. 2,3Dichloro Benzoyl Chloride 2.045 kg 2. Amino Guanidine Bicarbonate 1.06 kg 3. Cuprous Cyanide 1.09 kg 4. Hexane 2.03 kg 180

Case No.:46/6/82ALC4/2011

Party Name:DHANUKA LABORATORIES LTD. 05.07.2011 Status:Case Approved HQ File :01/82/050/00165/AM12/ RLA File :05/23/040/00011/AM12/ Lic.No/Date:0510289089 28.04.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 42/82 meeting held on 18.01.2011 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 Tan Endo Powder 1 Kg. 1. PenGK 1.089 kg 2. Dimethyl formamide 4.685 kg 3. Acetone 2.525 kg 4. Methylene Chloride 2.783 kg 5. Para Nitro Benzyl Bromide 0.632 kg 6. Trimethyl Phosphite 0.342 kg 7. Triethyl Amine 0.279 kg 8. Toluene 0.852 kg

181

Case No.:23/14/82ALC4/2011

Party Name:R L FINE CHEM 05.07.2011 Status:Case Deferred HQ File :01/82/050/00414/AM12/ RLA File :07/24/040/00018/AM12/ Lic.No/Date:0710078830 28.04.2011 Defer Date:30.08.2011 182

Case No.:47/6/82ALC4/2011

Party Name:JOCIL LTD., 05.07.2011 Status:Case Deferred HQ File :01/82/050/00166/AM12/ RLA File :09/24/040/00051/AM12/ Lic.No/Date:0910046581 29.04.2011 Defer Date:02.08.2011 Decision :Committee considered case as per agenda and in light of written comments of DIPP dated 05.07.2011, decided to call for the following information from the firm. 1. Production and the consumption certificate indicating the consumption of all raw materials (both indigenous and imported) of same or similar product during the past two years duly certified by the concerned Central Excise. 2. Quantity of Glycerine obtained as a by product and its commercial value. 3. Percentage TFM in the export product. Accordingly, case was deferred for 02.08.2011. 183

Case No.:21/14/82ALC4/2011

Party Name:R L FINE CHEM 05.07.2011 Status:Case Approved HQ File :01/82/050/00412/AM12/ RLA File :07/24/040/00017/AM12/ Lic.No/Date:0710078885 29.04.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 44/82 meeting held on 27.01.2010 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 Nortriptyline Hcl 1 kg. 1. 1,Bromo 3 Chloro Propane 0.96 kg 2. Tetra Hydro Furan 0.71 kg 3. Ethyl Chloro Formate 0.46 kg 184

Case No.:22/14/82ALC4/2011

Party Name:R L FINE CHEM 05.07.2011 Status:Case Deferred HQ File :01/82/050/00413/AM12/ RLA File :07/24/040/00016/AM12/ Lic.No/Date:0710078875 29.04.2011 Defer Date:30.08.2011 185

Case No.:24/14/82ALC4/2011

Party Name:RAY CHEMICALS PRIVATE LIMITED, 05.07.2011 Status:Case Approved HQ File :01/82/050/00415/AM12/ RLA File :07/24/040/00019/AM12/ Lic.No/Date:0710078878 29.04.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 45/82 meeting held on 02.02.2010 dated 19.07.2005 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

Export product Export Qty. Sl.No. Import items Qty. allowed Doxepin Hcl BP/USP 1kg. 1. 1Bromo3Chloro Propane 1.12 kg 2. Magnisium Metal 0.19 kg 3. Tetrahydrofuran 0.68 kg 186

Case No.:25/14/82ALC4/2011

Party Name:RAY CHEMICALS PRIVATE LIMITED, 05.07.2011 Status:Case Approved HQ File :01/82/050/00416/AM12/ RLA File :07/24/040/00020/AM12/ Lic.No/Date:0710078884 29.04.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 10/82 meeting held on 09.06.2009 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 Dothiepin Hcl 1 Kg. 1. Thiophenol 0.65 kg 2. 1 Bromo 3 Chloro Propane 0.92 kg 3. Tetra Hydro Furan 0.50 kg 4. Acetone Not allowed since not shown in manufacturing process. 187

Case No.:9/10/82ALC4/2011

Party Name:GULBRANDSEN CHEMICALS PVT LTD 05.07.2011 HQ File :01/82/050/00268/AM12/ RLA File :34/24/040/00013/AM12/ Lic.No/Date:3410030091 04.05.2011 188

Case No.:7/10/82ALC4/2011

Party Name:KLJ PLASTICIZERS LTD, 05.07.2011 Status:Case Deferred HQ File :01/82/050/00266/AM12/ RLA File :05/23/040/00038/AM12/ Lic.No/Date:0510289756 05.05.2011 Defer Date:02.08.2011 189

Case No.:3/14/82ALC4/2011

Party Name:IPCA LABORATORIES LIMITED 05.07.2011 Status:Case Approved HQ File :01/82/050/00394/AM12/ RLA File :03/94/040/00081/AM12/ Lic.No/Date:0310629733 05.05.2011 Defer Date:30.08.2011

Case No.:8/14/82ALC4/2011

Party Name:BLISS GVS PHARMA LTD. 05.07.2011 Status:Case Approved HQ File :01/82/050/00399/AM12/ RLA File :03/94/040/00115/AM12/ Lic.No/Date:0310629717

190 Q e 0 /8 /050/00399/ / e 03/9 /0 0/00 5/ / c o/ ate 03 06 9 05.05.2011 Decision : Committee considered case as per agenda and in line with SION A412 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 Gynospan Suppositories (Net weight 15.200 kg) Net content of Anhydrous Phloroglucinol 76.32 kgs. And net content of Trimethyl Phloroglucinol 98.10 kgs. 15.200 kgs. 1. Anhydrous Phloroglucinol 77.84 kg 2. Trimethylm Phloroglucinol 100.00 kg 191

Case No.:9/14/82ALC4/2011

Party Name:IPCA LABORATORIES LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/00400/AM12/ RLA File :03/94/040/00091/AM12/ Lic.No/Date:0310629729 05.05.2011 Defer Date:30.08.2011 192

Case No.:2/14/82ALC4/2011

Party Name:ELPPE CHEMICALS PRIVATE LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/00393/AM12/ RLA File :03/94/040/00122/AM12/ Lic.No/Date:0310630488 10.05.2011 Defer Date:02.08.2011 Decision :Committee decided to defer case for 02.08.2011 for comments of Department of C&PC. 193

Case No.:4/14/82ALC4/2011

Party Name:ALTA LABORATORIES LTD. 05.07.2011 Status:Case Approved HQ File :01/82/050/00395/AM12/ RLA File :03/94/040/01131/AM11/ Lic.No/Date:0310630444 10.05.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/289/2009 PIIII dated 24.12.2009 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 Sodium Salicylate 1 Kg. 1. Salicylic Acid 0.88 kg 194

Case No.:17/14/82ALC4/2011

Party Name:ADCOCK INGRAM LTD, 05.07.2011 Status:Case Approved HQ File :01/82/050/00408/AM12/ RLA File :07/24/040/00039/AM12/ Lic.No/Date:0710079098 10.05.2011 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. C N 19/14/82 ALC4/2011 P t N ADCOCK INGRAM LTD M t N /D t 14/82 ALC4/2011 St t C

195

Case No.:19/14/82ALC4/2011

Party Name:ADCOCK INGRAM LTD, 05.07.2011 Status:Case Deferred HQ File :01/82/050/00410/AM12/ RLA File :07/24/040/00040/AM12/ Lic.No/Date:0710079103 10.05.2011 Defer Date:30.08.2011 196

Case No.:7/14/82ALC4/2011

Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 05.07.2011 Status:Case Approved HQ File :01/82/050/00398/AM12/ RLA File :03/95/040/00999/AM11/ Lic.No/Date:0310630757 11.05.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/99/2008/Ch.II dated 24.06.2010 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 Export product Exp. Qty. Sl.No. Import items Qty. allowed 2 Chloro 4 Fluoro Tri Fluoride 1 Kg. 1. Para Fluoro Toluene/4 Fluoro Toluene 0.924 kg 197

Case No.:11/14/82ALC4/2011

Party Name:LUPIN LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/00402/AM12/ RLA File :03/95/040/00106/AM12/ Lic.No/Date:0310630659 11.05.2011 Defer Date:30.08.2011 198

Case No.:52/10/82ALC4/2011

Party Name:TIDE INDUSTRIES 05.07.2011 Status:Case Deferred HQ File :01/82/050/00311/AM12/ RLA File :34/24/040/00320/AM11/ Lic.No/Date:3410030202 12.05.2011 Defer Date:02.08.2011 199

Case No.:40/14/82ALC4/2011

Party Name:DEEPAK NITRITE LIMITED 05.07.2011 Status:Case Approved HQ File :01/82/050/00431/AM12/ RLA File :31/24/040/00205/AM11/ Lic.No/Date:3110048116 12.05.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/66/2007/Ch.II dated 05.07.2011 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 Export product Exp. Qty. Sl.No. Import items Qty. allowed 2Ethyl Hexyl Nitrate 1 Kg. 1. 2Ethyl Hexanol 0.765 kg

Case No.:6/14/82ALC4/2011

Party Name:AARTI INDUSTRIES LIMITED 05.07.2011 Status:Case Deferred

200 HQ File :01/82/050/00397/AM12/ RLA File :03/94/040/01151/AM11/ Lic.No/Date:0310631308 13.05.2011 Defer Date:30.08.2011 201

Case No.:5/9/82ALC4/2011

Party Name:SUPREET CHEMICALS PVT.LTD. 05.07.2011 Status:Case Approved HQ File :01/82/050/00256/AM12/ RLA File :03/95/040/00134/AM12/ Lic.No/Date:0310631532 18.05.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/37/2007/Ch.II dated 01.07.2011 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 Export product Exp. Qty. Sl.No. Import items Qty. allowed 5Amino1,2Xylene3Sulfo 2’DMABS or Ash Acid 1 Kg. 1. 4NitroOXylene (4NOX) 1.074 kg 2. Ethanol Amine (2Ethanol Amines) 0.865 kg 202

Case No.:10/14/82ALC4/2011

Party Name:METROPOLITAN EXIMCHEM LTD. 05.07.2011 Status:Case Approved HQ File :01/82/050/00401/AM12/ RLA File :03/95/040/00112/AM12/ Lic.No/Date:0310631539 18.05.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/48/2008/Ch.II dated 05.07.2011 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 Export product Exp. Qty. Sl.No. Import items Qty. allowed CESBS RESTD 4(2Chloro Ethylsulfonyl) Butyric Acid 1 Kg. 1. Gamma Butyrolactone 0.665 kg 2. 2Mercapto Ethanol 0.691 kg 203

Case No.:31/14/82ALC4/2011

Party Name:MATRIX LABORATORIES LTD 05.07.2011 Status:Case Deferred HQ File :01/82/050/00422/AM12/ RLA File :09/24/040/00023/AM12/ Lic.No/Date:0910046786 19.05.2011 Defer Date:30.08.2011 204

Case No.:12/14/82ALC4/2011

Party Name:VISWAAT CHEMICALS LIMITED 05.07.2011 Status:Case Approved HQ File :01/82/050/00403/AM12/ RLA File :03/95/040/00140/AM12/ Lic.No/Date:0310632273 23.05.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/128/2010/Ch.II dated 04.07.2011 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 VICASOL MV01 Diethanol Isopropanol Amine (DEIPA) 1 Kg. 1. Diethanol Amine 0.580 kg 2. Propylene Oxide 0.360 kg 205

Case No.:33/10/82ALC4/2011

05.07.2011 HQ File :01/82/050/00292/AM12/ RLA File :05/23/040/00045/AM12/ Lic.No/Date:0510291486 24.05.2011 206

Case No.:34/10/82ALC4/2011

05.07.2011 HQ File :01/82/050/00293/AM12/ RLA File :05/23/040/00046/AM12/ Lic.No/Date:0510291487 24.05.2011 207

Case No.:35/10/82ALC4/2011

05.07.2011 Status:Case Deferred HQ File :01/82/050/00294/AM12/ RLA File :05/23/040/00048/AM12/ Lic.No/Date:0510291488 24.05.2011 Defer Date:30.08.2011 208

Case No.:42/14/82ALC4/2011

Party Name:BEST VALUE CHEM PVT. LTD. 05.07.2011 Status:Case Approved HQ File :01/82/050/00433/AM12/ RLA File :34/24/040/00001/AM12/ Lic.No/Date:3410030347 24.05.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/14/2005Ch.II dated 25.06.2009 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 Export product Exp. Qty. Sl.No. Import items Qty. allowed Hexyl Salicylate 1 Kg. 1. nHexanol 0.511 kg 2. Salicylic Acid 0.691 kg 209

Case No.:15/14/82ALC4/2011

Party Name:MEDREICH LIMITED 05.07.2011 Status:Case Approved HQ File :01/82/050/00406/AM12/ RLA File :07/24/040/00052/AM12/ Lic.No/Date:0710079379 25.05.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 52/82 meeting held on 23.03.2010 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 Cli d i C l 150 1 N 1 Cli d i H l BP 173 53

Clindamycin Capsules 150 mg 1 No. 1. Clindamycin Hcl BP 173.53 mg Clindamycin Capsules 300 mg 1 No. 1. Clindamycin Hcl BP 347.06 mg 210

Case No.:45/10/82ALC4/2011

Party Name:DEEPAK NITRITE LIMITED 05.07.2011 HQ File :01/82/050/00304/AM12/ RLA File :31/24/040/00008/AM12/ Lic.No/Date:3110048261 26.05.2011 Decision :Committee decided to defer case for 02.08.2011 for comments of Department of C&PC. 211

Case No.:46/10/82ALC4/2011

Party Name:GOLD STAR CHEMICALS PVT.LTD. 05.07.2011 Status:Case Approved HQ File :01/82/050/00305/AM12/ RLA File :03/94/040/00004/AM12/ Lic.No/Date:0310633089 26.05.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 40/82 meeting held on 04.01.2011 and in consultation with technical authorities 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 Dehydro ThioPara Toluidine Sulfonic Acid 1 Kg. 1. Para Toluidine 1.852 kg 212

Case No.:14/14/82ALC4/2011

Party Name:ALKALOIDS CORPORATION 05.07.2011 Status:Case Deferred HQ File :01/82/050/00405/AM12/ RLA File :02/24/040/00033/AM12/ Lic.No/Date:0210159560 26.05.2011 Defer Date:30.08.2011 213

Case No.:43/14/82ALC4/2011

Party Name:BEST VALUE CHEM PVT. LTD. 05.07.2011 Status:Case Deferred HQ File :01/82/050/00434/AM12/ RLA File :34/24/040/00027/AM12/ Lic.No/Date:3410030384 26.05.2011 Defer Date:02.08.2011 214

Case No.:1/14/82ALC4/2011

Party Name:STERLING AUXILIARIES PVT LTD 05.07.2011 Status:Case Deferred HQ File :01/82/050/00392/AM12/ RLA File :03/95/040/00138/AM12/ Lic.No/Date:0310633159 27.05.2011 Defer Date:02.08.2011 215

Case No.:16/14/82ALC4/2011

Party Name:P.D. NAVKAR BIOCHEM PVT.LTD, 05.07.2011 Status:Case Deferred HQ File :01/82/050/00407/AM12/ RLA File :07/24/040/00055/AM12/ Lic.No/Date:0710079420 27.05.2011 Defer Date:02.08.2011

p 216

Case No.:30/14/82ALC4/2011

Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:14/82ALC4/2011 05.07.2011 Status:Case Approved HQ File :01/82/050/00421/AM12/ RLA File :34/24/040/00034/AM12/ Lic.No/Date:3410030397 30.05.2011 217

Case No.:35/14/82ALC4/2011

Party Name:ALEMBIC LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/00426/AM12/ RLA File :34/24/040/00031/AM12/ Lic.No/Date:3410030413 30.05.2011 Defer Date:30.08.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 6/82 meeting held on 11.05.2010 and in consultation with technical authority present in meeting, decided to ratify norms on repeat bais 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 Fenofibrate 1 Kg. 1. 4Chloro,4 Hydroxybenzophenone 1.316 kg 2. Acetone 2.71 kg 3. Ethyl Acetate 4.47 kg 4. Iso Propyl Alcohol 5.43 kg 5. Methylene Chloride 4.92 kg 6. Activated Charcoal 0.100 kg 218

Case No.:44/14/82ALC4/2011

Party Name:ONEIRO CHEMICALS LTD 05.07.2011 Status:Case Deferred HQ File :01/82/050/00435/AM12/ RLA File :34/24/040/00037/AM12/ Lic.No/Date:3410030415 30.05.2011 Defer Date:30.08.2011 219

Case No.:18/14/82ALC4/2011

Party Name:LAKE CHEMICALS PRIVATE LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/00409/AM12/ RLA File :07/24/040/00059/AM12/ Lic.No/Date:0710079495 31.05.2011 Defer Date:30.08.2011 220

Case No.:45/14/82ALC4/2011

Party Name:GULBRANDSEN CHEMICALS PVT LTD 05.07.2011 Status:Case Deferred HQ File :01/82/050/00436/AM12/ RLA File :34/24/040/00035/AM12/ Lic.No/Date:3410030424 31.05.2011 Defer Date:30.08.2011 221

Case No.:34/14/82ALC4/2011

Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:14/82ALC4/2011 05.07.2011 Status:Case Deferred HQ File :01/82/050/00425/AM12/ RLA File :34/24/040/00042/AM12/ Lic.No/Date:3410030477 02.06.2011 Defer Date:30.08.2011 Decision : Committee decided to defer case for 30 08 2011 for comments of Department of Pharmaceuticals

222

Case No.:33/14/82ALC4/2011

Party Name:AARTI ORGANIC 05.07.2011 Status:Case Deferred HQ File :01/82/050/00424/AM12/ RLA File :08/24/040/00050/AM12/ Lic.No/Date:0810100306 09.06.2011 Defer Date:02.08.2011 223

Case No.:27/14/82ALC4/2011

Party Name:GURUDEV DYESTUFF INDIA PVT.LTD. 05.07.2011 Status:Case Approved HQ File :01/82/050/00418/AM12/ RLA File :08/24/040/00009/AM12/ Lic.No/Date:0810100342 10.06.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 3/82 meeting held on 20.04.2010 and in consultation with technical authority present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed 4,4 Diamino Sulphanilide 1 kg. 1. Aniline Oil 0.458 kg 2. Acetic Acid 0.317 kg 3. Para Nitro Aniline 0.728 kg 4. Caustic Soda Flakes 0.545 kg 5. Soda Ash 0.350 kg 224

Case No.:28/14/82ALC4/2011

Party Name:CADILA HEALTHCARE LTD., 05.07.2011 Status:Case Approved HQ File :01/82/050/00419/AM12/ RLA File :08/24/040/00047/AM12/ Lic.No/Date:0810100309 10.06.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 45/82 meeting held on 02.02.2010 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 Warfarin 1 mg Tablets 1 Million 1. Warfarin Sodium Clatharate USP 1.09 kg 2. Hydroxypropyl Cellulose 3.67 kg 3. Lactose Monohydrate 168.08 kg 4. Magnesium Stearate 1.37 kg 5. 60 CC White HDPE Round Bottle As per packing policy 6. Bottle 300 CC White HDPE 7. 33 MM White PP Screw Cap 8. 45 MM White PP Screw Cap Warfarin 2 mg Tablet 1 Million 1. 2.18 kg 2. 3.66 kg 3. Lactose Monohydrate 167.12 kg 4. Magnesium Stearate 1.38 kg 5. 6. 7. 8. 1. 2.725 kg 2. Hydroxypropyl Cellulose 3.68 kg

Warfarin 2.5 mg Tablets 1 Million 2. 3.68 kg 3. Lactose Monohydrate 166.98 kg 4. Magnesium Stearate 1.38 kg 5. 6. 7. 8. Warfarin 3 mg Tablets 1 Million 1. 3.27 kg 2. 3.66 kg 3. Lactose Monohydrate 165.53 kg 4. Magnesium Stearate 1.37 kg 5. 6. 7. 8. Warfarin 4.0 mg Tablets 1 Million 1. 4.36 kg 2. 3.67 kg 3. Lactose Monohydrate 165.12 kg 4. Magnesium Stearate 1.38 kg 5. 6. 7. 8. Warfarin 5.0 mg Tablets 1 Million 1. 5.45 kg 2. 3.67 kg 3. Lactose Monohydrate 159.50 kg 4. Magnesium Stearate 1.38 kg 5. 6. 7. 8. Warfarin 6.0 mg Tablets 1 Million 1. 6.54 kg 2. 3.66 kg 3. Lactose Monohydrate 156.07 kg 4. Magnesium Stearate 1.37 kg 5. 6. 7. 8. Warfarin 7.5 mg Tablets 1 Million 1. 8.175 kg 2. 3.66 kg 3. Lactose Monohydrate 156.87 kg 4. Magnesium Stearate 1.37 kg 5. 6. 7. 8. Warfarin 10 mg Tablets 1 Million 1. 10.90 kg 2. 3.66 kg 3. Lactose Monohydrate 154.67 kg 4. Magnesium Stearate 1.37 kg 5. 6 B ttl 300 CC Whit HDPE A ki li

225

Case No.:26/14/82ALC4/2011

Party Name:KLJ PLASTICIZERS LTD, 05.07.2011 Status:Case Deferred HQ File :01/82/050/00417/AM12/ RLA File :05/23/040/00100/AM12/ Lic.No/Date:0510293856 20.06.2011 Defer Date:02.08.2011 226

Case No.:29/14/82ALC4/2011

Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/00420/AM12/ RLA File :03/95/040/00094/AM12/ Lic.No/Date:0310637252 20.06.2011 Defer Date:02.08.2011 227

Case No.:36/14/82ALC4/2011

Party Name:SHASUN PHARMACEUTICALS LIMITED 05.07.2011 Status:Case Deferred HQ File :01/82/050/00427/AM12/ RLA File :04/24/040/00069/AM12/ Lic.No/Date:0410125143 20.06.2011 Defer Date:31.08.2011 Decision :Committee decided to defer case for 31.08.2011 for comments of Department of Pharmaceuticals. 228

Case No.:37/14/82ALC4/2011

Party Name:TRIGON CHEMICALS PVT. LTD. 05.07.2011 Status:Case Deferred HQ File :01/82/050/00428/AM12/ RLA File :31/83/040/00045/AM12/ Lic.No/Date:3110048740 20.06.2011 Defer Date:02.08.2011 Decision :Committee decided to defer case for 02.08.2011 for comments of Department of C&PC. 229

Case No.:38/14/82ALC4/2011

Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 05.07.2011 Status:Case Approved HQ File :01/82/050/00429/AM12/ RLA File :03/95/040/00113/AM12/ Lic.No/Date:0310637533 21.06.2011 Decision : : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/99/2008Ch.II dated 03.01.2011 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 Export product Exp. Qty. Sl.No. Import items Qty. allowed Brontrifluoride Tetrahydrofuranpure BF3THF Pure (47.5%) 1 Kg. 1. Brontrifluoride Tetrahydrofuran (46%) 1.06 kg 230

Case No.:39/14/82ALC4/2011

Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 05.07.2011 Status:Case Approved HQ File :01/82/050/00430/AM12/ RLA File :03/95/040/00132/AM12/ Lic.No/Date:0310637536

21.06.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/27/2008Ch.II dated 10.07.2009 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 Export product Exp. Qty. Sl.No. Import items Qty. allowed Fluoro Benzene (Purity 99.9%) 1 Kg. 1. Fluoro Benzene (Purity 99.5%) 1.02 kg 231

Case No.:46/14/82ALC4/2011

05.07.2011 Status:Case Deferred HQ File :01/82/050/00437/AM12/ RLA File :05/23/040/00105/AM12/ Lic.No/Date:0510294191 21.06.2011 Defer Date:30.08.2011 232

Case No.:47/14/82ALC4/2011

Party Name:FDC LTD 05.07.2011 Status:Case Deferred HQ File :01/82/050/00438/AM12/ RLA File :03/94/040/00152/AM12/ Lic.No/Date:0310637790 22.06.2011 Defer Date:30.08.2011 233

Case No.:48/14/82ALC4/2011

Party Name:DORFKETAL CHEMICALS INDIA PVT.LTD. 05.07.2011 Status:Case Approved HQ File :01/82/050/00439/AM12/ RLA File :03/94/040/00260/AM12/ Lic.No/Date:0310637998 22.06.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 41/82 meeting held on 11.01.2011 and in consultation with technical authorities 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 Chemical Antlifoulant Trade Name DA 2339/DA2313/DA2316/DA2339M/DA 2394/DA2304C/DA2309 (Organic mixture containing 8% of Benzylidene2,6 DitertiarybutylCyclohex 2one 18% of Decanedioic Acid 1Hydroxy2,6 DimethylenePiperidin4yl Methyl Ester 75% of Aromatic Solvent C10C11) 1 Kg. 1. 2,6,Di Tertiary Butyl Phenol 0.070 kg 2. DinPropyl Amine 0.0045 kg 3. Di Methyl Sebacate 0.069 kg 4. 4 Hydroxy Tempo/4 Hydroxy/2,2,6,6 Tetramethyl/Piperridine NOxyl 0.115 kg 5. Di Butyl Tin Oxide 0.0028 kg 6. Aromatic Solvent 0.750 kg

Case No.:49/14/82ALC4/2011

Party Name:NEW ALLIANCE DYECHEM PVT. Status:Case

234 LTD., 05.07.2011 Approved HQ File :01/82/050/00440/AM12/ RLA File :03/95/040/00227/AM12/ Lic.No/Date:0310638201 23.06.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 39/82 meeting held on 28.12.2010 and in consultation with technical authority present in meeting, decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export Product Export Qty. Sl.No. import items Qty. allowed EDTA Diammonium (Liquid) Assay Min. 40% 1 kg 1. EDTA (Ethylene Diamine Tetra Acetic Acid) Assay Min. 98% 0.377 kg

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Para 4.7 Decision(DRAFT)

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