DGFT Committee Minutes

Oflice of Directorate General of Foreign Trade New Delhi -0

Para 4.7 Decision

MEETING I\UMBER : 12182-ALC41?014 MEETING DATE : 10.12.2014 But actually held on 15.12.2014 The Meeting No. 12182 ol 2014-15 to consider the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2OO9-14 pertaining to Chemical and Allied products and falling under Chapter 29 and 30 was scheduled lor 10.12.2014 but actually held on 15.12.2014 under the Chairmanship of Shri Jaikant Singh, Addl. DGFT in Room No.11, Udyog Bhawan, New Delhi. Following members were present:- Dr. Nitin Jain D/o Biotechnology Shri Nirmal Kumar, Deputy Director General of Foreign Trade Ms. Swati Kumari, O/o Dc (MSME) Shri D.N. Mathur. Consultant, Department of Pharmaceutical Shri Jasbir Singh, Consultant, Department of C&PC Shri Mahendra Vikram Singh, Foreign Trade Development Officer The committee went through the minutes of earlier NC -lll meeting No. 11/82 scheduled for 26.11.2014 but actually held on 01.12.2014 and approved the same. The following cases/issues were discussed and the committee took the decision as mentioned against each case.

Case No A-12

M/s Pharmazcl(India)PVt Ltd Meeting No.l2lAMl5 dated - 15.12.2014 FNo 01/82/162/00059/AM14/DES― III Decision: It was decided to defer the case for 12.01.2015 for comments of Department of Pharmaceuticals. s SATYA DEEPTHA PHARMACEUTICALS LTD

Case No B― l12

FNo 01/82/050/01540/AM09/DES I‖ FNo 01/82/050/00254/AM10/DES■ 11 FNo 01/82/050/00163/AM10/DES‐ :‖ FNo 01/82/050/OC1793/AM10/DES■|| Meeting No.12lAM l5 dated - 15.12.2014 adv Licc No 0910036722 datcd i5 01 09 adv Licc No 0910038375 datcd 29 06 09 adv Licc No 0910038170 datcd 10 06 09 adv Licc No 0910040146 datcd 03 12 09 RAF No 09/24/040/00350/AM09 RAF No 09/24/040/00087/AM10 RAF No 09/24/040/00018/AM10 RAF No 09/24/040/00355/AM10 Decision:In the light of written comments rcccivcd from Departmcnt of Pha111laceuticals vide their OM No 35011/268/2014-PINorms)datCd 28 H 2014,l was dccided to rati″ thC nO‖ :Is undcr Para, 4 7 ofHBP vl as pcr dctails given belo、v or as app‖cd by thc frm,whichcvcr is lcss:

fu{ may take appropriate action as per the decision of Norms Committee. l―(3-ChlorophenyりPiprazine HcI

Case No B l13

M/s ALCHYMARSICM SM PRIVATE UMITED Meeting No 12/AM 15 datcd-15 122014 F No 01/82/50/00111/AM14/DES― |‖ Adv Lic No 0410144366 dated 25 03 2013 RLA F No 04/24/40/00279/AM-13 Decision : lnformation received from the firm and sent to Department of Pharmaceuticals for their comments. The case is deferred for 12.01.2015. Casc No B― l14 M/sV市in Labs Ltd Mccting No 12/AM 15 datcd-15 122014 FNo 01/82/50/00871/AM08/DES-lⅡ RAF No 09/24/040/00138/AM08 Adv Lic No 0910031028 datcd 01 08 2007 Decision: It was decided to defer the case for 12.0 I .2015 for comments of Department of Pharmaceuticals.

Case No B-115

M/s. Sainor Laboratories Pvt.Ltd.. Ltd Meeting No.l2lAM l5 dated - 15.lZ.Z0l4 Filc No 01/82/50/528/AM10/DES― IH Filc No 01/82/50/621/AM10/DES― IH RAF No 09/24/040/00040/AMll RAF No 0924/040/00040/AMll Adv Licc No 0910039225 datcd O1 09 2009 Adv Lice No 0910039590 datcd 14 10 2009 Decision: It was decided to defer the case for 12.01.2015 for comments of Department ofC&PC

Case No B-116

M/s. Sainor Laboratories Pvt.Ltd.. Ltd Meeting No 12/AM 15 datcd-15 122014 F No 01/82/050/00350/AMl1/DES― |‖ RAF No09/24/040/00040/AMll Adv Lice No 0910042075 datcd 19 05 2010 Decision : lt was decided to defer the case for 12.01.2015 for comments of Departme,nt of C&pC --S ヽ ′ヽハ

M/S lndia G

Case No 3‐ 117

F No01/82/50/01012/AM 12/DES‐ |‖ Mee■ng No 12/AM15 dated-15122014 Adv‖c No 0510305501 dated 17 10 11 committee considered the case as per agenda and in consultation with the technical authority present in the meeting, it was decided to amend the description of import items at serial No. 1 in respect of above advance authorization as per details given below From To Ethyl Alcohol(90± 1%) DENATURED ETHYL ALCOHOL The rest of the minutes would remain same RA may take appropriate action as per the decision of Norms Committee' M/s DiVIS LABORATORIES LTD′ Casc No B-l18 F No 01/82/050/00461/AM 14/DES I‖ Meeting No.l2lAM15 dated - 15.12.2014 Adv lic No 0910056692 dated 05.072013 RLA F No 09/24/040/00150/AM14 Decisioll:In tlle light ofヽvritten comments receivcd from Departmcnt of Pha‖ ‖accuticals vidc thcir OM No 350H/645/2014-PIぃo‖llS)dated 28 H 2014,I was decidcd to cnhance tlle no‖ :ls for DimethyI Formamide to 8.70 kg/kg from the eartier 6.10 kg/kg. The decision taken in meeting no. 50/82 dated 13.3.2012 stands ameided to the extent mentioned above. There is no change in rest of the minutes. RA

Case No B-119

M/s DEEPAK NOVOCHEM TECHNOLOGIES LTD′ Meeung No 12/AM15 dated-15122014 F No 01/82/050/00248/AM 14/DES i‖ RLA F No 31/83/040/00221/AM13 Adv lic No 3110058085 dated 26 04 2013 oecision, ln the light of written comments received from Department of chemicals and Petrochemicals vide their U.O No. 14010/39l2OLf-Ch. ll dated 12.12.2014, it was decided to revise the norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Quantity S No Import items Quantity Allowed 2,6 Xylidine l kg 1 2,5 xylenol 1 90 kg RA mav take appropriate action as per the decision of Norms Committee.

Case No 3-120

M/s. Wanbury LTD. (Formerly Known as Doctors Organic Chemicals Ltd.) Meeing No 12/AM15 dated-15122014 FNo 01/82/50/01175/AM08/DES■ !l RLA F No 05/23/040/237/AM12 い

Adv.Lic.No.2610006381dated 14.09.2007 RAF.No.26/80/040/00002/AM08 Decision: It was decided to defer the case for 12.01.2015 for comments of Department of Pharmaceuticals. Paty Name:PROVENTUS iMCet No/Date:12/82¨ LIFE SCIENCES PRIVATE LIMITED, ALC4/2014 10.12.2014 1臨高蔦囲蕊扁~開 嗣耐 Decision: Itwasdecidedtodeferthecasefor 12.01.2015 forcommentsof Departmentof Pharmaceuticals. ヽ4eet No/Date:12/82¨ ALC4/2014 10.12.2014 12.01.2015 pproved Defer Date: ParサName:NEULAND LABORATORIES LTD RLA File :09/24/040/00144/AM10/¬温辮α酬∞ 38818 Status:Deffered and Re-indexed

Case No.:11/20/82…

|:01/82/050/00422/Aヽ410/ cision : In the light of written comments received from Department of Pharmaceuticals vide ir OM No.3501116212014-PI(Norms) dated 28.11.2014, it was decided to ratifu the norms ler Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less: Export Product Export Ouantity Ｓ 。 Ｎ 。 Import Item Qty. Allowed ke/ke lsopropyl-(z)-7-[( I R,2R,3R,5 S)-3, 5- lihydroxy-2- [(3 R)-3 -Hydroxy-5 - Phenylpentyl)l Cyclopentyll-5 - Fleptenoate (Latanoprost) l kg 1 Tris Tes 1.69 2 Pyridinium tosylate 0.090 3 Acetone 18.45 1it/kg 4 Ethyl Acetate 80.74 1it/kg 5 n-Hexane 15.35 1it/kg 6 Silica Gel 13.17 kg/kg 7 N-Heptane 944.64 1it/kg 8 Acetonitrile 36.9 1it/kg 9 HPLC Grade lsopropyl Alcohol 55,35 1it/kg RA may take ippropriate action as per the decision of Norms Committee.

Case No.:14/24/82…

ALC4/2010 Name:SAINOR ▼ TORIES PVT

一 |::‖:翌:IЁIl:l:liliЁfli ision:Copy of production and consumption data of allinputs has been received from the flHn same has been sent to Department ofPha11llaceuticals fbr their corninents.Case is deferred for 12.01.2015. ニユυ■■●νυr′ V八r^▼―――‐ ^― ――一―――― ・ ^ ,comments.Case is deferred for same has been sent to Departrnent ofPhallllaceuticals for their 12.01.2015. Party Name:VIVIMED LABS LIMITED trfi t C"py "f p."drtt -d **rrpti"" autu of un inputs has been received from the firm same has been sent to Department of Pharmaceuticals for their comments. Case is deferred for 12.01.2015. Pa●y Name:MYLAN LABORATORIES LIMITED 「 8 B為 0脚4 Decision:It was decided to deferthe case fbr 12.01.2015 for comments ofIDepartment of ticals. : In the light of written comments received from Department of Pharmaceuticals vide their M No.350H/243/2014-PIo(0111lS)dated OCtober 2014,it was decided to call from the f11111 Meet No/Date:12/82‐ Status:Deffered ‐

Case No.:17/19/82‐

Case No.:90/42ノ82¨

Party Name:VIVIMED ゝ江ect No/Date:12/82‐ Status:Deffered LABS LIMITED

Case No.:93/42/82‐

ALC4/2011

Case No.:28/28/82‐

ALC4/2012 Status:Deffered Date:12.01.2015 following information : VI 器3月5γ008WAMW IЪ ち属:υoo2WAMlソ RLA File :It was decided to deferthe case for 12.01.2015 for comments ofDepartment ofC&PC. 14 Re-indexed File 1/82/050/00531/AM12/ 137/AM12/ Re-indexed No/]Date:12/82- Re-indexed File 1/82/050/01128/AM12/ 7/AM12/ 114.10.2011 Re-indexed 10.12.2014

(a) Certificate of Analysis from Foreign supplier for the relevant .onrign.*t of irrport.a crude product. (b) COA of Export product as per shipping Bill/purchase Order. The case is deferred for 12.01.2015 「蹴1嚇IttM | Lic.No/Date:0910054777 1Defer Date: :01/85/050/00016/AMl4t 1:09t24t04OtOO46BtAMt3t lrS.Or.zOr: 12.01.2015 n:Committeeconsiderthecaseanditisobservedthatthe.@ ized by the firm under chapter 23. Being the Bulk Drug, tire eiport product n."-di to b" lassified under chapter 29. Accordingly, it was decided to advise the firm to revise the application rith proper ITC (HS) codes for the export product. case is defelTed for 12.01.2015 Paゥ Meet No/Date:12/82¨ tatus:■pellered nd Re¨indexed Name:BIOLOGICALE lX-C+tZOru 10.12.2014

Case No.:16/3/85‐

Status:Deffered

Case No.:32/8/82-

ALC4/2013 Decision : It was decided to defer the case for 12.01 .20 I 5 for comments of Departmeni of Pharmaceuticals. Meet No/Date:12/82‐ Name:WOCKHARDT IALC4/2014 10.12.2014 Status:Deffered and Re-indexed : The firm was requested to furnish the production and consumption data for the last years certified by Central Excise Authority , reminder letter has been also sent on .01.2014. Copy of application has been already sent to DCGI for their comments. fer Date:12.01.2015 Lic.No/Date:0910056HOIDefer :01/82/050/01028/ANI11 4/ 1:09/24/040/00058/AⅣl14/ 123.05.2013 Date:12.01.2015 Mcet No/Date:12/82‐ ALC4/2014 '鯰 鱚

Case No.:142/10/82‐

ALC4/2013 Party Name:GLAND PHARMA LITИITED Status:Deffered : It was decided to defer the case for 12.01.2015 for comments of Department of ALC4/2014 10.12.2014

Case No.:134/14/82-

Status:Deffered 131ALC4/2013 10.12.2014 No/Date:12/82‐ Re-indexed 0.12.2014 Ю目漱蔦蔦蕉肝鷺図 0“7晨M「臨鸞 10055421 12.01.2015 File File 10734494 Date: 1/82/050/00325/AR/114/ 01/AM14/ 115.05.2013 12.01.2015 No.:42/20/82- No/1Date:12/82‐ Re-indexed

:0 1)82l0s0/007 1 9/AM 1 4 t l:$ Da fia0/00s08/AM B I 124.0s.2013 Decision:,It was decided to renlind the f1111l to fumish the foHoWing infollllation: l. Complete technical details as per Appendix 33 2. Past production vis-i-vis actual coniumption of input duly certified by Central Excise Authorities. The case was deferred for 12.01.2015. Pa●y Name:BLISS GVS PHARMA LTD. us:Deffered nd Re‐ lndexed Ｆ ‐ ‐ ８ ト for 12.01.2015 for comments of Department of Pharmaceuticals. fu.tyN"..:VIVEK lMeetNo/Date:12182' tus:Deffered PHARVIACHEM ALC4/2014 nd Re-indexed 10.12.2014 Lic.No/Date: l3 10043416 lDefer :0ル82/050/00366/AM14/1:13/24/040/00032/AM12/119.06・ 2013 Date:12.01.2015 : It was decided to call from the firm copy of relevant DML for each export product with detailed working on the requirement of API in each case. The case was deferred for 12.01.2015。 Party Name:STERICAT lMeet No/Date:12182- IGUTSTRINGS PVT. IALC4/2014 10.12.2014 : It was decided to remind the firm to furnish the copy of Manufacturing process flow copy DML (Drug Manufacturing Licence),Batch Manufacturing Record and clarification on quantities ofimport inputs(Whether itis in Grams or in Milligrams)mentiOned in the pplication. The case was deferred for 12.01.2015

Case No.:201/10/82‐

ALC4/2013 した .No/Dttα 0410147551

Case No.:28/12/82‐

ALC4/2013 ALC4/2014 10.12.2014

Case No.:183/10ノ82‐

Case No.:111/10/82-

ALC4/2013 Status:Deffered 13∫:|:50/00294/AM14/ 1:ド:;ら:λ10/00091/AM14/ Tbj380001〕][12.01.2015 ision:It was decided to deferthe case for 12.01.2015 for conllnents of Department ofIPP. Status:Deffered Status:Deffered luq rite IRLAFne 10735499 No/Date:12/82- )LTD., Re-indexed No.:172/14/82- Name:RECKON No/Date:12/82- Re-indexed Date: 12.01.2015 Re-indexed No/Datc:12/82-

l@Ww6*.rr0r2or5 II lcertified by Quality control Incharge. The case was deferred for 12.0r.2015. 19 Status:Deffered and Re-indexed HQ File RLA File Lic.No/Date:0310739850 1Defer :01 1821050t00448t AMlt4t l:03 t95 t04ot\O256t Al/ll4t 102.07 .2013 Date:12.01.2015 P;"t.t", , C;.rritt."."mid"..d;G.^ffid it h* b* lTablets 200 mg and the input is also Entacapone Tablets 200 mg with 2oh wastage. It appears to lbe a case of refer ding only and no manufacturing activity is involved. It was decided to remind IDCGI to furnish their comments. The case was deferred for 12.01.2015. ヽ4eet No/Date:12/82- ALC4/2014 10.12.2014 HQ File :01/82/050/00503/Aゝ/114/ :03/94/040/00269/ANI114/ 悧鼎α“Ю科 "η開=

Case No.:27/13/82…

IALC4/2013 Party Name:ADVY CHEMICAL PVT.LTD. Decision : ln the light of written comments received from Department of Biotechnology vide their OM No. BT/|L/OS l23Ll2OO6-PlD dated 27.71.2074, it was decided to ratify norms under

Para 4.7 of HBP v1. as per details given below or as applied by the firm, whichever is less:

Item of Export Qty. S′ No Item of lmport Quantity allowed C.Reactive Protein Human Gram 1. Immobilized P- Aminophenyl Phosphoryl Choline 0.64 ml 2. PhenylMethyl Sulphonyl Fluoride 5.2 gm 3. Phosphocholine Chloride Calcium Salt,(P0378-SPEC) 4.Ogm 4. Calcium Chloride-2-Hydrate R.G Reag. 0.514 gm 5. DE 52 Pre― Swollen AIEC 0.042 gm may take appropriate action as per the decision of Norms Committee's.

Case No.:44/12/82…

P".ly N"."fNC[JBE - Mcet No/Date:12/82‐ ETHICALS PVT LTD :ALC4/2014 10.12.2014 HQ File :01/82/050/00468/Aヽ414/ Decision : Matter is under active consideration in Department of Pharmaceuticals. The case is felTed for 12.01.2015. Ｆ 購 “ ― Meet No/]Date:12/82- ALC4/2014 10.12.2014 Status:Deffered ParサName:GLAND PHARMA LIヽ江ITED lnq rit" fnr.A rit" lt-ic.NotOat e:09 100 5 67 7 2 Defer Date: No.:24/12/82¨ No/Date:12/82- WOCKHARDT Re-indexed AM14/110.07.2013

[A] |“ .0■29ぬ す | comments received Department of Pharmaceuticals vide their OM No. 35011122212014-PI(Norms) dated l.l2.2}l4 and in consultation with technical authority present in meeting, decided to ratiff under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- S.No. Import Item (1) Nolllis Applied (2) As per Central Excise Certificate (3) Batch Logshect (4) Lowest of (2)to(4) (5) 1 RCB Diol 71.51ng As per SION 57.75mg 2 Glass Vials 1.064nos. 1.0617 1.0565 1.0565nos ０ ， Rubber Stoppers 1.076nos. 1.0832 1.0794 1.076nos 4 Seals, Plastic and Rubber 1.064nos. 1.048 1.0310 1.031nos 5 Sodium chloride BP 0.000022kg Excipients & Consumables. Relevant, Net to Net 6 Benzyl alcohol BP 0.0000441it 7 Sodiunl hvdroxide USP 0.0000001kg 8 Hvdrochloric USP 0.00000041it 9 Tubing,Plastic 0.0006731it 10 Filters. Plastic 0.000181nos. Ant factor xa test kits 0.000101nos. 12 Ant factor lla test kits 0.000101nos. つ ′ Analvtical columns 0.000022nos. 14 Analytical guard columns 0.000022nos. Note:‐ These nolllls are specinc to Us FDA praCCt.The higher nolllls for packing materials shall be permissible only in respect of export to USA and will not be applicable on repeat basis. B]For Export of Rocuronium Bromide lniection 10mノ ml,10mi Vial USP… …………lNo. S.No. Import Item Nolllls Applied (2) As per Central Excise Certificate (3) Batch Logsheet (4) Lowest of (2)to(4) (5) 1 RCB Diol 142mg As per SIC)N 115.5mg 2 Glass Vials 1.07nos. 1.0927 1.0922 1.07nos ● ， Rubber Stoppers 1 . I 0nos. 1.1067 1.1053 1.10nos 4 Plastic Seals 1.05nos. 1.0643 1.0413 1.0413nos く υ Sodium chloride 0.000022kg Excipients & Consumables. Relevant, Net to Net 6 Benzyl alcohol 0.0000441it 7 Sodium hydroxide 0.0000001kg 8 Hvdrochloric 0.00000041it 9 Tubins 0.0006731it 10 Filters 0.000181nos. Ant factor xa test kits 0.000101nos. つ ４ Ant factor lla test kits 0.000101nos. For Exnort of Rocuronium Bromide Iniection l0me/ml.5ml Vial USP--------.---1No.

ξ ′ う 乙 Status:Deffered and Re-indexed ision : Committee considered the case and it has been observed that the export of Entacapone ablets 200 mg and the input is also Entacapone Tablets 200 mg with2%o wastage. It appears to a case of refer ding only and no manufacturing activity is involved. It was decided to remind I to furnish their comments. The case was deferred for 12.01.2015. ALC4/2014 10.12.2014 Re-indexed HQ File RLA File Lic.No/Date:3410037475 1Defer :01 1821050100930/AM 1 4 I i :34121 1040/00 1 63/AM I 4/ .23.07 .2013 12.01.2015 Decision : It was decided to call from the firm detailed justification for the import of 1039.076 kg API against the present advance authorization. The case was deferred for 12.01.2015 Party Name:PAB Meet No/Date:12/82- Status:Deffered and Re-indexed 10RGANICS PVT.LTD, ALC4/2014 10.12.2014 19島掲5剛術σAM″ 陽 λ監 0側05/AM‖ 匿 ∬器 α “ Ю7ZttB鳶 12劇2∝5 器3児5υ剛8仏MW闘 :OЮm l1/AMW Iギ器 α "Ю"・"B荒10.2知4 Decision : It was decided to remind the firm to furnish the following technical details: 1. echnical details as per Appendix 33 for conversion of Gadolinium to Gadopenteate Dimeglumine. 2. Volume of the Injection A/ial to be exported. The case was deferred for 12.01.201s Meet No/Date:12/82- ALC4/2014 10.12.2014 26 ● Ｄ Anahtical columns 0.000021nos. 14 Analyical guard columns 0.000021nos. te:- These norrns are specific to US FDA project. The higher noffns for packing materials shall permissible only in respect of export to USA and will not be applicable on repeat basis. may take appropriate action as per the decision of Norms Committee.

Case No.:21/12/82-

ALC4/2013 ParサName:BHARAT PARENTERALS LTD, Decision : It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 12.0 I .20 1 5 Party Name:UNIJULES LIFE SCIENCES LTD. Status:Deffered ALC4/2014 10.12.2014

Case No.:1/10/82-

ALC4/2013 Status:Deffered

Case No.:17/13/82-

ALC4/2013 [Hq rite lnr.a rit" 10 ILic,No/Date:3410037541 Defer No/Date:12/82- 4 AM14/ 18.07.2013 No.:68/17/82¨ No/]Date:12/82- No/Date:12/82- Re-indexed Re-indexed Ю Ｃ Ｍ Ｎ ａ ｍ ｅ ｍ

卜 01/82/050/00493/AM14/1:34/24/040/00085/AM14/Fl.07.2013 Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) ision : It was decided to send a copy of application again to Department of Pharmaceuticals their comments. The case was deferred for 12.01 .2015- Party Name:UNIVERSAL lMeet No/Date: l2l 82- Status:Deffered BIOFUELS PRIVATE IALC4/2014 and Re-indexed 10.12.2014 lDate:12.01.2015 tus:Deffered Re-indexed Defer Date:12.01 .2015 11)|]:):50/00279/AⅣl15/ F::'::;:':/0。155/AM14/ 圏ち :l」 e:0910056959[;r:12012015 Decision : It was decided to defer the case for I 2.01 .20 I 5 for comments of Department of C&PC. Party Name:CTX ヽ4cet No/Date:12/82- LIFESCIENCES PVT IALC4/2014 10.12.2014 Lic.No/Date:0310744552 1Defer :0 t I 821 050 I 0o 62s I A}/lI 4 / l:$ 19 4 / 040/003 07lA M t 4 I ,07 .05.20 t 3 Datc:12.01.2015 Decision : It was decided to call from the firm following information:- (a) Complete technical ils as per Appendix 33. (b) Past production vis-i-vis actual consumption of inputs duly by Central Excise Authority. The case was deferred for 12.01.2015 iffi.t", r It was a*ia.O t" *ff trc f"ff"ifi"f".r"'rti f.", tfr. f,., , il C"*pf.t. t..tri."f ldetails as per Appendix 33 for the export product (ii) Past production vis-d-vis actual consumption lof input duly certified by Central Excise Authorities. The case was deferred for 12.01.2015. ヽ4cet No/Date:12/82‐ ALC4/2014 10.12.2014 鵬 掲5m“ 椰A剛″
躙 辮 憫Ю7黎 “ B鳶12回 5 11)13:):50/00510/AⅣl14/ 剛 iO/00132/A〕И 14/ [111::I::e:0310744838[;r:120.2015 [ユ]Ili11::I11;::II:電〈驚FyttЪ懲肥」 l:f裏:_:鼻fⅧit:li:l雷:itn i Excise Authorities.The case was deferred fbr 12.01.2015。 Mcet No/Date:12/82‐ ALC4/2014 10.12.2014 HQ File :01/82/050/00549/Aヽ/114/ 胤監γ剛 "晨剛ィ1蹴鼎α "Ю科 4832

Case No.:31/4/82-

Case No.:40/14/82‐

Status:Deffered

Case No.:11/13/82‐

ALC4/2013 Meet No/Date:12/82-

Case No.:34/13/82‐

Party Name:WANBURY LIMITED(FORNIERLY PEARL ORGANICS Status:Deffered Status:Deffered 11 Re-indexed File 10.12.2014 Re-indexed No.:73/13/82- Re-indexed

: It was decided to call the following information from the firm : i) Complete technical ils as per Appendix 33 for the export product (ii) Past production vis-d-vis actual consumption input duly certified by Central Excise Authorities. The case was deferred for 12.01 .2015. li: Mcet No/Date:12/82‐ ALC4/2014 10.12.2014 34 12.01.2015 ision : It was decided to call the following information from the firm : i) Complete technical ils as per Appendix 33 for the export product (ii) Past production vis-d-vis actual consumption of input duly certified by Central Excise Authorities. The case was deferred for 12.01.2015. Pany Meet No/Date:12/82- Name:WOCKHARDT IALC4/2014 LINIIITED 10.12.2014 HQ File RLA File Lic.No/Date:0310744861 lDefer :01/82/050/00551/AM14/1:03/95/040/00320/AM14/ 112.08.2013 Date:12.01.2015 Decision : Committee considered the case and it has been observed that the export of Entacapone Tablets 200 mg and the input is also Entacapone Tablets 200 mg with2Yo wastage. It appears to be a case of refer ding only and no manufacturing activity is involved. It was decided to remind DCGI to furnish their comments. The case was deferred for 12.01.2015. Paty Name:DR REDDYS LABORATORIES LINIIITED 造き淵に嘘~醤∬ぱ:鷲I:: 10122014 1 鷺ち爵浙OЮ0222/AMイ 1悧鼎 α酬00571"B鳶 12■2∝5 く υ り ， HQ File :01/82/050/00583/ANl11 4/ Reply received from the firm and sent to Department of Pharmaceuticals for their The case is deferred for 12.01 .2015. Mcet No/Date:12/82¨ ALC4/2014 10.12.2014 36 HQ File RLA File :01/82/050/00702/AM14/103/95/040/00407/ANI114/ Decision : It was decided to call from the firm following technical details: D Content of Buffering agent in the export product. iD Complete technical details as per Appendix 33 case was deferred for 12.01.2015 Paty Name:ACTAVIS PHARNIIA MANUFACTURING PVT.LTD RLA File l:0 4 124 I 040 10009s/AM I 4/

Case No.:76/13/82‐

ALC4/2013 Status:Deffered

Case No.:75/13/82-

ALC4/2013

Case No.:107/13/82…

ALC4/2013

Case No.:117/14/82‐

Party Name:MAC CmM IPRODUCTS(INDIA) IPRIVATE LIMITED 撚器α“Ю 75962B鳶 12■2m5 Case No。:3/12/82… ALC4/2013 [:'1llli;::127/AM14/ Meet No/Date:12/82‐ Status:Deffered and Re-indexed Date:12.01.2015 Lic.No/Date:0410148864 22.08.2013 12 Re-indexed 10744834 AM14/ 125/AM14/ Re-indexed Ｄ 一 」 Ａ Ｆ ｉ ‐ ｅ 4 10.12.2014

solution of import items contains 8% water). The case was deferred for 12.01 .2015. Ｆ Ｉ Ｌ Ｆ Ｉ Ｉ Decision : It was decided to send a copy of application again to DCGI for their comments Mect No/Date:12/82‐ ALC4/2014 10.12.2014 Lic.No/Date:0710097668 1Defer :01/83/050/00471/AM14/1:07/24/040/00152/AM14/ 22.08.2013 Decision : It was decided to defer the case for 12.01.2015 for comments of Department of Pharmaceuticals. Date:12.01.2015

Case No.:43/16/82中

ALC4/2013 Pa“y Name:SYMBIOTEC PHARNIIALAB LTD。, Status:Deffered and Re-indexed : It was decided to defer the case for 12.01.2015 for oomments of Department of : It was decided to call from the firm a copy of Master Batch Formula duly certified by lity Control In charge. The case was deferred for 12.01 .201 5 :01/82/050/00897/AM14/ Decision : It was decided remind the firm to furnish complete technical details as per Appendix 33. The case was deferred for 12.01 .2015. Deffered Re-indexed Decision : It was decided to call from the firm a copy of Master Batch Formula duly certified by ality Controlln charge. The case was deferred for 12.01.2015 tus:Deffered Re-indexed ]Lic.No/Oate:09 1 005 79 t 4 lDefer 躙 掲5υ∞お9晨MW膨 淵 α∞鯰7ハⅢ″ 1悧鼎 αmの %OB鳶 12劇2例5 Ｆ Ｌ ｒ ｌ Pa●y Name:STERICON PHARMA PVToLTD., Status:Deffered Status:Deffered

Case No.:35/17/82‐

ALC4/2013 :響霊併瓶ドド鮒~ Status:Deffered

Case No.:46/16/82…

jru-n rit" .lni No.:9/30/83- No/Date:12/82- Re-indexed 11早)lll):50/008o6/AM14/ Re-indexed 「AM14/ 118.09.2013 Name:SI‐ IASLIN No/Date:12/82- No.:38/17/82- Party Name:MYLAN IMcet No/Date:12/82-

l:o t I s2t 0s0 100900/AM l al l:09 Da fi40 t oo322t AMt 4 I I r +. r o.zo r : IDate:12.01.2015 Decision : It was decided to call from the firm the following technical details : Molecular weight of each input and output product. % Yield on molar basis along with copy of technical literature in support of yield envisaged. Past production vis-a-vis actual consumption of inputs duly certified by Central Excise Authorities. The case was deferred for 12.01.2015. ¶ 脇蕊蔦
語 B忠2叩 : It was decided to call from the firm copy of relevant Drug Manufacturing Licence. The was deferred ibr 12.01.2015 Mcet No/Date:12/82- IALC4/2014 10.12.2014 HQ File RLA File 鷹 Cぶ鼎α ttЮ“紗66函 :01/82/050/00217/AM15/:34/24/040/00184/AM14/ 21.10.2013 Date:12.01.2015 n : It was decided call form the firm following information: Details of manufacturing process with chemical equations, molecular formula, molecular weights ii) Yield obtained in each step iii) Authentic technical literature in support of yield obtained iv) CA certificate certiffing the production of export item achieved by you for the past three years and corresponding consumption ofeach input. case is deferred for 12.01.2015 Mect No/Date:12/82‐ ALC4/2014 10.12.2014 Status:Deffered Re-indexed O"cisioo : It was decided to defer the case for I 2.0 I .20 I 5 for comments of Department of Pharmaceuticals. HQ File :01/82/050/00884/Aヽ414/ RLA File :03/94/040/00458/AM14/ LicoNo/Date:0310753955 17.10.2013 Defer Date:12.01.2015 Status:Deffer ed and Re- NIteet No/Date:12/82‐ ALC4/2014 10.12.2014 ４ ７ HQ File :01/82/050/00276/ANII 15/ RLA File :03/95/040/00575/AM14/ ision : It was decided to defer the case for I 2.0 1 .20 I 5 for comments of Department of

Case No.:22/17/82‐

Party Name:ATHENA DRUG DELIVERY SOLUTIONS PRIVATE Meet No/Date:12/82‐ Status:Deffered

Case No.:6/20/82¨

Party Name:ZIM LABORATORIES LTD.

Case No.:28/4/82-

ALC4/2014 Re‐indexed No。:213/3/82‐ Name:TATVA AN PHARNIA Re-lndexed PVT LTD

Case No.:46/4/82¨

48 ParサName:ZIM LABORATORIES LTD. HQ File RLA File Lic.No/Date:0310754827 1Defer fi 1 I 82 I 050 I OO2g 4 I AMI 5 I :03 19 5 I 040/005 95/AM I 4/ 1,22. I 0.20 13 Date:12.01.2015 : It was decided to defer the case for 12.01.201 5 for comments of Department of icals. HQ File Lic.No/Date:0910057999 1Defer :01 l82l 050 I 00005/AM I 5 I i:09 l24l 040/003 54 I AMt 4l i24.1 0.20 | 3 Date:12.01.2015 Decision : Committee considered the case and it has been observed that both import and export items are same. As per the details given by the firm, purity of import item is Not Less Than 99.0Yo w/w) and that of export item is NLT 97.5% and NMTI02.0% (wlw). It was decided to take ments ofDCGI. Defer Date:12.01.2005 Patt Name:EMCUIじ IMeetNo/Dtte:12/82‐ PHARMACEUTICALS IALC4/2014 LTD. 10.12.2014 NIteet No/Date:12/82- ALC4/2014 10.12.2014 49 "賜星月 "Ю舵ぉ晨my囲濡蕊而階∬器 CmЮttb2B鳶12m2m5 1:Iill胤」 I」Illde`ided tO deferthe cttζ し fbr 12.0112biS fOrc61ilients Ofうも partment 6r ξ υ HQ File :01/82/050/00070/AM15/ Ъ ち刷iυ∞蜆νAM″ 囲 器 α酬∞賀 “ 4B荒 12m2m5 : It was decided to defer the case for 12.01 .2015 for comments of Department of icals. -ffi lx.cqtzots I I ParけName:ALCHEM INTERNATIONAL LTD. 諄鮒~ Defer Date: I 2.01 .201 5 : It was decided to remind the firm to fumish following technical details: Actual content of Digoxin in imported digitalis Lanata Leaves supported foreign supplier Assay of Export Product NIlect No/Date:12/82- Status:Deffered and Re-indexed

Case No.:1/3/82‐

Party Name:EYTAN LABS LIMITED

Case No.:37/4/82‐

ALC4/2014 Status:Deffered

Case No.:66/3/82‐

Party Name:GLAND PI‐IARMA LIMITED Status:Deffered Status:Deffered 15 by COA from 14 No/Date:12/82‐ Re-indexed Re-indexed Re-indexed Re-indexed 審》瀬らニ ぶ ＞ 　 　 ぅ 跳1品`゛

iii) Past production vis-a-vis Actual consumption of leaves for the last 3years duly certified by Central Excise Authorities. case was deferred for 12.01 .2015. Party Name:TITAN Meet No/Date:12/82‐ :Deffered LABORATORIES PVT. IALC4/2014 Re-indexed 10.12.2014 Lic.No/Date:0310761921 1Defer :01/82/050/00943/AM14/:03'5/040/00637/AM14/ 16.12.2013 Date:12.01.2015 Mcet No/Date:12/82- ALC4/2014 10.12.2014 Lic.No/Date:0210198392 1Defer :01/82/050/00185/AM15/ 卜02/24/040/00053/AM14/ 102.01.2014 Date:12.01.2015 PartyNamo:GLOBAL jMeetNo/Date:12182- :Deffered CALCIUM PRIVATE .ALC4/2014 Re‐indexed LIMITED, 10.12.2014 ision : It was decided to defer the case for l2.0l.20l5for comments of Department of Party Name:AKZO Mect No/Date:12/82- ALC4/2014 10.12.2014 Status:Deffered INOBEL INDIA LIMITED nd Re-lndexed Lic.No/Date:02101984581Defer :01/82/050/00049/AM15/:02/24/040/00168/AM13/ 103.01.2014 Date:12.01.2015 Decision : It was decided to deferthe case for l2.0l.20l5for comments of Department of Pharmaceuticals. ParけName:ASTRIX LABORATORIES LTD., Meet No/Date: ALC4/2014 10.12.2014 12/82- us:Dellereo Re-indexed 571器 島児50Ю9093/AMly陽ち刷:α0049αAML/賭∬3mα 0910058826BttL」 .0.::i5 : It was decided to defer the case for 12.01.2015for comments of Department of ticals. tus:

Case No.:8/18/82-

: It was decided to defer the case for I 2.0 1 .201 5 for comments of Department of

Case No.:181/3/82…

IALC4/2014 Party Name:AKZO NOBEL INDIA LIMITED Status:Deffered Decision : It was decided to defer the case for l2.0l.20l5for comments of Department of

Case No.:24/8/82‐

ALC4/2014

Case No.:45/3/82¨

ALC4/2014

Case No.:89/3/82-

Case No.:117/6/82-

Party Name:VIVIMED 581ALC4/2014 LABS LIIⅥITED Approved File Re-indexed 4/ 102.01.2014 ALC4/2014 梅静「 撃褥 File 跡 瀑ニ

59 : ln the light of written comments received from Department of chemicals and s vide their U.O No. 14010/138/2011/Ch ‖dated 12.12.2014′ it was dec:ded to norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, ichever is less: Export Product Export Quantity S.No lmport Product Quantity Allowed TCC OR VIVILIDE OR 3,3,4'―TRICHLORO CARBANILIDE L kg 1. PARA CHLORO ANILINE 0.546 kg 2. 3,4‐DICHLORO PHENYL ISOCYANATE 0.627 kg 3. TOLUENE 2.000 kg 4. METHANOL 0.500 kg RA may take appropriate action as per the decision of Norms Committee Mcet No/Date:12/82‐ tus:Deffered ALC4/2014 Re‐indexed 10.12.2014 ision : It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 12.01 .2015. No.:204ノ3/82‐ Meet No/Date:12/82- ALC4/2014 10.12.2014 Deffered ALC4/2014 Re-indexed HQ File RLA File Lic.No/Date:0910058895 Defer Date:12.01.2015 :01/82/050/00208/Aヽ/115/ 1:09/24/040/00514/AM14/ 110,01.2014 : lt was decided to send a copy of application again to Department of Pharmaceuticals their comments. The case was defened for 12.01.2015. 器疏5α0019σAMlylЪち刷 iυ005BハMW陪ざ究 Tα 0910058896B鳶 12Ю L2015 Parυ Name:OGENE SYSTEMSINDIA PVT. LTD. Status:Deffered ParけName:VIVIMED LABS LIMITED

Case No.:192/3/82‐

ALC4/2014 Pa●y Name:VIVIMED LABS LIMITED ALC4/2014 10.12.2014 : It was decided to defer the case for 12.01 .201 5for comments of Department of ― 器 星児5υ00059/AMⅣ I鷺危鵬 α00529晨Ⅲ″ 17 |ぶ鼎 揃 ∞ "舵 5PI缶Dttα Y 19/AM15/ 7/AM14/ 109.01.2014 No.:208/3/82- No/Date:12/82- Re-indexed 611器島児 50Ю0212晨Mlyl鷺ち刷 :υ00515ハMW囲 12.01.2015

)ecision : Committee considered the case as per agenda and in light of written comments received rom Department of Pharmaceuticals vide their OM No. 3501 l/3lll20l4-Pl(Norms) dated l1.l I 1014 and in consultation with technical authority present in meeting, decided to ratifo norrns nder para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Exp. Qtv. SI.No. lmport items Qty.AIlowed Kq/kq IRBESARTAN l k9 1 Ortho Toluyl Benzonitrile / 2- Cyano-4-Methvl Biphenvl 0.891 2 2-n-Butyl-4-spirocyclopentane- 2-imidazoline-5 -One Hcl 0.88 3 Activated Carbon 0.100 4 Di-isooroovl ether 1.25 5 DimethvI Follllamide(DMF) 1.67 6 Methyl alcohol(Methanol) 4.28 7 NItethylene Chloride 1.35 concerned may take further necessary action as per above decision of NC.

Case No.:87/3/82…

Ｆ ‐ ‐ ６ ３ ‐ ‐ Ｆ ‐ ‐ ６ ４ ‐ ‐ Mcet No/Date:12/82- IALC4/2014 10。12.2014 Lic.No/Date:0910059155 1Defer :01/82/050/00091/AM15/ :09/24/040/00544/AⅣl14/ 104.02.2014 Date:12.01.2015 lDecision : It was decided to defer the case for 12.01.2015 for comments of Department of C&PC. lf薔棚‖ 7/3182‐ Paty Name:VIVIMED LABS LITИITED Status:Deffered and Re-indexed Ｆ ‐ ‐ ‐ ‐ ‐ ６ ５ ‐ ‐ ‐ ‐ ‐ lDecision : It was decided to deferthe case for 12.01.2015 for comments of Department of C&PC. HQ File lRLA File Lic.No/Date:09100592301Defer :01/82/050/00058/AM15/1:09/24/040/00552/AM14/ 10.02.2014 1Date:12.01.2015 Dl 1鱚緻 D" 貯鮒~ Decision:In the light ofwritten comments received their OM No.350H/331/2014-PI①(Orms)dated 01.1 following infollllation/technical details: Complete technical details as per Appendix -3 ing complete and balance chemical %Yield etc. Requirement and recovery of solvent at each st Technical Justification for requirement of each Past Production vis-i-vis Actual consumption < from Department of Pha111laccuticals vide 2.2014,it was decided to caH frorn the fll111 Status:Deffered ALC4/2014 10,12.2014 was deferred for 12.01.2015. 18 duly certified by Central Excise V Re-indexed No/Date:12/82- 1器島児 5υOm21晨Mly File 10059156 AM14/ 12.01.2015 だ 〔〕 ゞ

Case No.:167/3/82‐

ALC4/2014 ParりName:CIPLA LIMITED HQ File :01/82/050/00171/ANI11 5/ Decision : Committee considered case as per agenda and in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/292120L4-Pl(Norms) dated nil, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or applied by the firm, whichever is less: ] allowed for Lamivudine concerned may take further necessary action as per above decision of NC. IPa●y Name:ARENE LIFE ISCIENCES LIMITED. | | 鷺危刷iα∞ “ 薇MI「日明鰤隊 α "Ю“ 斃″ Defer Date:12.01.2015 : It was decided remind the firm to furnish complete technical details as per A Norms allowed for 1 No. Tablet Export ltems Abamune - L Baby Tablets / Abacavir Sulfate & Lamivudine Tablets For Oral Susp 60/30 mg Abamune - L Junior Tablets / Abacavir Sulphate I 2Omg+Lamivudine 60mg Tablet 612.O mg Abacavir and Lamivudine Tablets 600i300mg/ Abacavir Sulphate 600mg+Lamivudine 300mg Tablet (lR,2S,5R)―MENTHYL‐ 5S¨(CYTOSINE… 1- YL)‐ 1,3-OXATHIOLANE-2R‐CARBOXYLATE/ CME COMPOUND SODIUM BOROHYDRIDE DIPOTASSIUIⅥ HYDROGEN PHOSPHATE SALICYLIC ACID ETHYL ACETATE Status:Deffered ALC4/2014 110。12.2014 :01/82/050/00068/AM15/ 3.The casc was defelTed for 12.01.2015. 19 ▼ S.No Lamivudine Abacavir Sulphatt 1. 30.6 mg 51.2 mg 2. 61.2 mg L22.4 mg 3 306.O mg Sl.No. lmport items Qty allowed kg/kg 1. 2.19 2. 0.48 3. 1.9849 4. 0.79 5. TRIETHYLANIIINE 0.575 6 1.795 File No/]Date:12/82‐ Re-indexed IW 嘲 。ヽい1

群鮒~ Party Name:INCHEM LABORATORIES PRIVATE LIMITED RLA File :09/24/040/00568/AM14/ Lic.No/Date:09100592581Defer 12.02.2014 1Date:12.01.2015 Decision : It was decided to call from the firm the complete technical details as per Appendix 33 (ii) past production vis-avis actual consumption of inputs duly certified by Central Excise Authority. The case was deferred for 12.01 .2015. Mcet No/Date:12/82‐ Lic.No/Date:0510379132 12.02.2014 Defer Date: :01/82/050/00065/ANI11 5/

Case No.3113/3/82-

Party Name:RANBAXY LABORATORIES LTD ALC4/2014 10.12.2014 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1153312012-PI(Norms) dated 27.12.2012, it was decided to ratifr norms under

Para 4.7 of FIBP vl as per details given below or as applied by the firm, whichever is less:

Export Product Export Qtv. SI.No. lmport items Qtv. allowed Imipenem Technical (Crude) l kg 1 (3R,4R)-4-ACETOXY-3‐ ((R)‐ (TERT― BUTYLDIMETHYLSILYLOXY)― ETHYL‐2-AZETIDINONE 3.44 kg 2 4 DIMETHYL AMINOPYRIDINE 0.021 kg 3 ACETONITRILE 0,768 kg 4 ACETONE 10.975 kg 5 CYCLOHEXANE 14.22 kg 6 CYSTEAMINE HYDROCHLORIDE 0.78 kg 7 DIPI‐IENYL CHLOROPHOSPHATE 2.44 kg 8 N,N‐DHSOPROPYL ETHYLAMINE 3.52 kg 9 FORMIC ACID 3.15 kg 0 ISOPROPYL ALCOHOL 0.505 kg 1 METHYLENE CHLORIDE 14.269 kg 2 METHANOL 1.37 kg り ， METI‐IANE SULFONIC ACID 0.51 kg 4 N‐lИETHYL MORPHOLINE 0.39 kg PALLADIUM SPONGE 8.65 gΠゴkg 16 TETRAHYDROFURAN 2.768 kg/kg 17 TOLUENE 2.526 kg 18 TRIETHYLAMINE 2.03 kg may take appropriate action as Pe the decision of Norms Committee. 20 Re-indexed File 賓 財 黒醇籠

Party Name:VIVIMED LABS LINIIITED ALC4/2014 10.12.2014 HQ File RLA File Lic.No/Date:0910059263 1Defer :0 1 I 821 050 I 0005 2/AM I 5 / l:09 /2a I 040 I 00 5 821 AMr 41 12.02.20 t 4 Date:12.01.2015 D""t.ir, , It *"i decided to defer the case for 12.01 .2015 for comments of Department of Mect No/Date:12/82‐ ALC4/2014 10.12.2014 1器島児 50Ю 01lαAMlダ : ln the light of written comments received from Department of Chemicals and rochemicals vlde their U.O No.14010/138/2011/Ch l:dated 12.12.2014′ it was decided to tify norms under Para 4.7 of HBP v1. as per details given below or as applied by the firm, Export Product Export Quantity S.No lmport Product Quantity Allowed DISODIUM PAヽ40ATE/DSP l kg 1. 3 HYDROXY 2 NAPTHOIC ACID (BON ACID) 1.19 kg 2. PARA FORNIALDEHYDE 0.120 kg 3. SODIUM HYDROXIDE 0.300 kg 4. SODIUM CHLORIDE 0.450 kg RA may take appropriate action as per the decision of Norms Committee Mcet No/Date:12/82- ALC4/2014 |:llilll:[lll」Itidecidedtodeferthecasefor12.01.2015 for comments ofI)epartment of

Case No.:112/3/82-

Party Name:VIVIMED LABS LIMITED Status: Party Name:ARENE LIFE SCIENCES LIMITED. Status:Deffered 110.12.2014 ICase No.:64/6/82¨ HQ File :01/82/050/00466/Aゝ/115/ RLA File Lic.No/Date:0310770862 1Defer ic.No/Date:01 :03194104010}7}7lAMt4l llS.O2.2Ol4 jDate:12.01.2015 Decision : It was decided to defer the case for 12.01 .201 5 for comments of Department of Pharmaceuticals. 「 猥謎胤響 6溜82 降濫買Ъ:Rlビ IMedNo/Dttα 12/82‐ IALC4/2014 21 No.:48/3/82‐ No/Date:12/82- Re-indexed 70 is less: Re-indexed File File 0059285 1/82/050/00077/AR/115/ AM14/ 114.02.2014 12.01.2015 No/Date:12/82- 14 Re-indexed 10.12.2014 ●・

Ito.rz.zot+ HQ File :01/82/050/00220/AM15/ RLA File :05/24/040/00431/AM14/ Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 350l1l32Ol2Ol4-PI(Norms) dated 28.11.2014, it was decided to ratiff norms under

Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less:

Export product Export Qtv. Sl.No. lmport items Qty. allowed Kombinil-Duo Eye/Ear Drops 5ml pack 1. Dexamethasone 3.6863 kg against export of 744′ 000 No.of5 mlpack ICase No.:86/3/82‐ Status:Deffered INOBEL INDIA LIMITED ALC4/2014 ,亜mments ofDepartment ofC&PC. ⅣIcet No/Date:12/82- ALC4/2014 10.12.2014 HQ File RLA File :01/82/050/00020/AM15/ :09/24/040/00592/AM14/ Decision : ln the light of written comments received fronn Department of Chemicals and Petrochemicals vide their U.O No.14010/138/2011/Ch:l dated 12.12.2014′ it was decided to ratify norms under para 4.7 of HBP v1 as per details given below or as applied by the firm, is less: Export Product Export QuantitY S.No lmport Product Quantity Allowed DANTUFF‐ C (CLIMBAZOLE) l kg CHLORO ETHER KETONE or (1,CHLORO,(4‐ CHLOROPHENOXY 3,3-DINIIETI‐IYL 2- BUTANONE) 1.110 kg 2. IMIDAZOLE 0.289 kg 3. POTASSIUM CARBONATE 0.600 kg may take apprOpriate action as perthe decision of Norms Committee HQ File Date:12.01.2015 嘱期 騒鰹 lhし 。 剛趣副鏑嚢ε む"° 鷺岬 蜘か 竃ふ冨 襦 脚ぶ

Case No.:16/3ノ82-

ALC4/2014 ParけName:VIVIMED LABS LINIIITED Lic.No/Date:0910059375 21.02.2014

case No.:105/3/82‐

Status:Deffered ALC4/2014 :01/82/050/00109/A卜/115/ 22 Udy°9 V Name:AKZO No/Date:12/82- Re-indexed 10.12.2014 10200380 12.01.2015 Date:

Decision : lt was decided to call from the firm the complete technical details as per Appendix 33. case was deferred for L2.OL.20L5.

Case No.:161/3/82¨

ALC4/2014 1器3児5νOm6yAMly 日本 12m2m5 Party Name:UNIMAX Meet No/Date:12/82‐ Re-lndexed ICHEMICALS PVT LTD. ALC4/2014 10.12.2014 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/315/2014-PI(Norms) dated 01.12.2014, it was decided to call from the firm the following technical details: i) Copy of certificate of Analysis of lmported Azithromycin Dihydrate IP grade on Actual content basis vis-a-vis specifications under Indian Pharmacopia. ii) A similar COA of the Export Product vis-avis the specifications laid down in USP -36 iii) Justification / Reasons for Reprocessing. case was defelTed for 12.01.2015. ０ ０ ， ′ fst"tr.D"ff*.d land Re-indexed I Decision : It was decided to defer the case for 12.0 I .201 5 for comments of Department of Pharmaceuticals. 押押i器 EЮ ‐ ヽ4cet No/]Date:12/82‐ ALC4/2014 10.12.2014 |::し 'ilλ :0/00605/AM14/ 1:|:::】ら 1lTe:0910059425 80

Case No.:233/3/82‐

ALC4/2014 :01/82/050/00237/AM15/ l:08 Da fi40 I 00 5261 AMt 4l Lic.No/Date:0810129185 25.02.2014 Date:12.01.2015

Case No.:129/3ノ82‐

ALC4/2014 :01/82/050/00133/Aヽ/115/ Decision : Committee considered the case as per agenda and in light of written comments receir from Department of Pharmaceuticals vide their OM No. 35011128012014-PI(Norms) da 01.12.2014 and in consultation with technical authority present in meeting, decided to rat nonns under para 4.7 of FIBP as per details below or as applied by firm whichever is lower:- Export product Exp. Otv. SI.No. Import items Qty.A1lowed K」kg CAPECITABINE l kg 1 2,3 -Di-O-Acetyl-5 -Deoxy-5- Fluorocytidine 1.19 2 Methylene Chloride 3.575 ● フ Methanol 0.625 concerned may take further necessary action as per above decision of NC. LABORATORIES LINIIITED

Case No.:7/3/82‐

ALC4/2014 Status: 23 Name:CADILA No/Date:12/82- THCARE LTD., 10。12.2014 File 膨 ／ 10.12.2014

1器島児 5υ00011晨Mly l飩蕊 扁 Lic.No/Date:0910059427 Defer Date: 26.02.2014 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 350111327/2014-PI(Norms) dated 28.11.2014 and in consultation with technical authority present in meeting, decided to ratifu norrns under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product 恥 Ｑ ｔ ｙ ． SI.No. lmport items Qty.AIlowed Kgノkg Pemetrexed Disodium Hemipentahydrate l kg 1 4 -[2 - (2 - Amino-4, 7 -d ihydro -4 - oxo-3 h-pyrrolo [2,3 -pyrimidin- 5-yllethyll-benzoic acid ξ υ う Ｚ 2 2-chloro‐4,6-dirnethoxy l,3,5,triazine 1.00 3 Acetonitrile 3.762 4 Acetone 3.791 5 N,N-dimethylformam i de 1.575 6 Toluene 1.854 7 Dichloromethane or Methylene chloride 9.689 8 Isopropyl alchohol 6.288 RA concerned may take further necessary action as per above decision of NC.

Case No.:5/3/82-

Parly Name:INDO Meet No/Date:12/82- PHYTO CHEMICALS ALC4/2014 PVT LTD 10.12.2014 Lic.No/Date:0510380433 1Defer :01/82/050/00009/AM15/:05/23/040/00494/AM14/ 127.02.2014 Date:12.01.2015

Case No.:118/6/82‐

ALC4/2014 ParりName:SPECTRUM IMeetNo/Date:12/82- Status:Deffered LIFE SCIENCES and Re-indexed PRIVATE LINIIITED 10.12.2014 12.01.2015 ision : It was decided to defer the case for 12.01.2015 for comments of Department of Paty Name:ZIM LABORATORIES LTD. R4eet No/Date:12/82- ALC4/2014 10.12.2014 Status:Deffered

Case No.:162/3/82-

ALC4/2014 lHq rite れた。 No/Dtte: 2330 lDefer Date: -NUEU KUMAR | |liii:::||:l:ill:il:i:lil:] [:||:ill:::||:||:||:lil:|:: 欄re Re-indexed : It was decided to defer the case for 12.01.2015 for comments of Department 1111)∫;):50/00520/AM15/ 14/AM14/ 127.02.2014

， ― ― l:0 I I 821 05 0 /00 I 66lAM 1 5 / l:03 19 5 I 040 I oog 67 I AMlt 4 I l,zt .oz.zo t + ision : It was decided to defer the case for 12.01.201 5 for comments of Department of Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011132312014-PI(Norms) dated 01.12.2014 and in consultation with technical authority present in meeting, decided to ratifu norns under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product 町 韓 SI.No. Import items Qty. Allowed FEEFUL(Capsules OfFerrous Sulphate with Folic Acid)(460 mg) l kg 1 Ferrous Sulphate Dried 153 mg/capsule concerned may take further necessary action as per above decision of NC.

Case No.:58/6/82…

ALC4/2014 Status:Deffered

Case No.:79/3/82-

ALC4/2014 ParサName:GLAND PHARMA LIヽ41TED Mcet No/Date:12/82- ALC4/2014 10.12.2014 Lic.No/Date:0910059455 :01/82/050/00083/AM15/1:09/24/040/00610/AM14/ 128.02.2014 : Committee considered the case as per agenda and in light of written comments received Department of Pharmaceuticals vide their OM No.350H/346/2014‐ PIoJ0111iS)dated 1.12.2014 and in consultation with technical authority present in meeting, decided to ratift under para 4.7 of FIBP as per details below or as applied by firm whichever is lower:- Product: Rocuronium Bromide Injection l0mg/ml,5ml Vial and l0mg/ml, 10ml Viat. A]For ExDOrt Of Rocuronium Bromide lniection 10mゴ m195mi Vial USP… …一――――-lNo. S,No. Import Item (1) Norms Applied (21 As per Central Exclse Certiflcate f3) Batch Logsheet (4) Lowest of (2)to(4) (5) 1 RCB Diol 71.51ng As per SION 57.75mA 2 Glass Vials l.064nos. 1.0617 1.0565 1.0565nos ● ′ Rubber Stoppers 1.076nos. 1.0832 1.0794 1.076nos 4 Seals, Plastic and Rubber 1.064nos. 1.048 1.0310 1.031nos ξ υ Sodium chloride BP 0.000022kg 6 Benzyl alcohol BP 0.0000441it 7 Sodiunl hydroxidc I」SP 0.0000001kg 8 Hydrochloric USP 0.00000041it 25 111)13:):50/00460/ANI11 5/ Re‐lndexed 12.01.2015

ｂ ‐ Ｒ 9 Tubing,Plastic 0.0006731it Excipients & Consumables. Relevant, Net to Net 10 Filters,Plastic 0.000181nos. Anti factor xa test kits 0_000101nOs. 12 Anti factor lla test kits 0.000101nos. り ， Analytical columns 0.000022nos. 14 Analyical guard columns 0.000022nos. lote:- These norns are specific to US FDA project. T e permissible only in respect of export to USA and wi B] For Exnort of Rocuronium Bromide Iniection 1( I I Appried I ttt tlt|(r)|(2)l I I RCB Diot I t42ms I 2 I Glass Vials I t.0znos. I 3 I Rubber Stoooers I t. I onos. I 4 I Plastic Seals I l.05nor. I 5 I Sodium chloride I 0.000022kg I 6 I Benrvlalcohol I o.oooo++tit I z I Sodium hvdroxide I 0.0000001ks I 8 I Hvdrochloric I O.oooooo+tit I 9 I tubins I o.ooo673lit I to Inihers | 0.ooot8tnos. I I I I Anti factor xa test kits | 0.000101nos. I 12 I Anti factor lla test kits I 0.000t0tnos. I 13 I Analvtical columns I 0.00002t nos. I 14 | Analytical guard | 0.000021nos. I l.otrrn. " | | lg!g:- These norrns are specific to US FDA project. 1 e permissible only in respect of export to USA and wil A concerned may take further necessary action i he higher nolllls fOr packing ll not be applicable on repeat )mノml。10mi Vial USP……… 「he hi8her noms for packh8 1i not be applicable on repeat ls per above decision of N materials shal basis. basis. C. …………lNo。

Case No.:106/3/82…

ALC4/2014 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:12/82‐ ALC4/2014 10。12.2014 HQ File :01/82/050/00110/AM15/ Decision : It was decided to send a copy of application to Department of C&PC. The case is deferred for I 2.0 1.20 I 5. P"rtyNaT.ARUDAA RLA File :03/95/040/00960/Aヽ414/ 1翻鼎α“Юη劉1 II:1ル駆 ):50/00188/AM15/ VIS LABS PRIVATE LIMITED RLA File :04/24/040/00266/AM14/ Meet No/Date:1 ALC4/2014 10.12.2014 Lic.No/Date:0410155776 1Defer 2/82‐ Date:12.01.2015 Status:Deffered Date:12.01.2015

Case No.:184/3/82¨

ALC4/2014 Status:Deffered Lowest of (2)to(4) rs、 115.5m2 1.07nos 1.10nos 1.0413nos Relevant, Net to Net Re-indexed Re-indexed 26

Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011131812014-PI(Norms) dated Ol.l2.2}l4 and in consultation with technical authority present in meeting, decided to ratiff norrns under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Exp. Otv. Sl,No. Import items Qty.Allowed kg Tartaric Acid BP/USP l kg 1 Tartaric Acld lndustrial Grade (Purity NMT96%) ξ υ ハ υ concerned may take further necessary action as per above decision of NC. 貯ザT卜 1甲酬通 S Status:Deffered 器晶児 5υ00521晨Ⅲダ閉蔦蔵薫二 ;1悧鼎α tt Ю %知∽ B荒12劇2m5

Case No.:122/3/82-

ALC4/2014 Party Name:NANDU ヽ4eet No/Date:12/82‐ Lic.No/Date:0710102530 1Defer Date: p3.03.2014 :01/82/050/00126/AM15/ :07/24/040/00408/AM14/ 諄鮒~ 4 File Re-indexed 10.12.2014 File 1/82/050/00941/AM15/ : ln the light of earlier decision taken by NC in its meeting No. 4182 meeting dated .2073, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or applied by the firm, whichever is less:

Qtv. Rosuvastatin Calcium l kg 1 Te■‐ butyl-2‐ {(4R,6S)-2,2- dimethy卜6¨[(methylcarbonyloxy) methyl]‐ 1,3-dioxan… 4-yl}aCetate (KSM,Side Chain) 1.871 kg 2. 4-(4-fl uorophenyl)-6-i sopropyl-2- (N-methyl-N- methanesulfonyl)amino)pyrimidine- 5-yl-Methanol 1.871 kg

Case No.:57/3/82¨

ALC4/2014 Party Name:JUBILANT lMeet No/Date:12182- LIFE SCIENCES LIMITED ALC4/2014 10.12.2014 Lic.No/Date:0510382053 1Defer :01/82/050/00061/AⅣl15/ :05/23/040/00506/AM14/ 18.03.2014 Date:12.01.2015 : It was decided to defer the case for 1 2.0 I .201 5 for comments of Department of C&PC. Party Name:BEST Mcet No/Date:12/82¨ Status:Deffered VALUE CHEM PVT. IALC4/2014 and Re-indexed 10.12.2014 Li"N"/Drt"34 10039601 E"* :01/82/050/00582/AM15/ 1:34/24/040/00298/AM14/ 19.03.2014 IDate:12.01.2015 lDecision : It was decided to defer the case for 12.01.2015 for comments of Department of C&PC. ヽlcet No/Date:12/82- ALC4/2014 10.12.2014 Status: Approved 調器 C“Юη "犯 95 Status:Deffered

Case No.:180/6/82-

ALC4/2014

Case No.:38/6/82-

Parly Name:CROWN CHEMICALS PVT.LTD., cision : Committee considered the case as per agenda and in the light of earlier decision taken NC in its 6/82 meeting dated 29.08.2074, it was decided to ratify norms under Para 4.7 of HBP as per details given below or as applied by the firm, whichever is less: Export product 恥 Ｑ ｔ ｖ ． SI.No. lmport items Qtv allowed Piperonal Min. Purity 98o/o l kg 1 Catechol(Min.PuHty 99%) 0.862 kg 2. Dichlo「omethane(Min.Pu百ty 990/0) 0.703 kg 3. DimethylsurOxide(Min.Puttty 990/0) 0.875 kg 4. Hexamine(Min.Pu‖ty 96%) 1.000 kq 5. Toluene(Min.Purity 970/0) 0.430 kg 6. lsopropyl Alcohol(Min.Pu面ty 990/0) 0.220 kg may take appropriate a<:tion as per the decision of Norms Committee. 28 W Ｆ Ｉ ‐ ” ― ト Re-indexed File lRLA File TD. File 135/AM14/

‐

Case No.:55/10/82‐

ALC4/2014 Party Name:SATYA PHARNIIACEUTICALS LTD ヽ江cet No/]Date:12/82¨ ALC4/2014 10.12.2014 Lic.No/Date:0910059590 1Defer 19.03.2014 1Date:12.01.2015 O""irion : It was decided to defer the case for 12.01.2015 for comments of Department of Pharmaceuticals. pproved Defer Date: ALC4/2014 10.12.2014 : It was decided to defer the case for 12.0 I .20 I 5 for comments of Department of Pharmaceuticals. Status:Deffered

Case No.:45/24/82‐

,eci-iil : Committee considered the case as per agenda and in light of written comments received .om Department of Pharmaceuticals vide their OM No. 35011131612014-PI(Norms) dated l.l2.21l4 and in consultation with technical authority present in meeting, decided to ratifu orms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Exp. Otv. SI.No. Import items Qty.Allowed kR Valacyclovir Hydrochloride Tablets l kg 1 Valacyclvoir I‐IcI BP/USP 556mg/500mg tablet & H12mg/1000mg tablet RA may take appropriate action as per the decision of Norms Committee.

Case No.:13/10/82-

IName:BRUNDAVAN LABORATORIES PRIVATE LTD., Date:12.01.2015

Case No.:123/3/82-

:01/82/050/00127/AⅣl15/ Status:Deffered :05/23/040/00508/AM14/ ぶ鼎α“Ю鬱"開蔦蔦 ALC4/2014 10.12.2014 LIFE SCIENCES lDecision : It was decided to callfrom the firm Drug Manufacturing Licence alongwith 雪器錆踏器 R D摺 鼎 『 辮 de 器響l等需:淵席F:恕ふ鷺足 : u調兜織議誡 :‖ File Name:VIVIMED No/Date:12/82‐ (ALATHUR) 4 ATE LIMITED Re-indexed Re¨lndexed Re-indexed 1器島児 5α01244晨M脚 No/Date:12/82‐

of approved items), and copy of Master Batch Formula duly authenticated by Quality Control The case was deferred for 12.01.2015. No.:181/6/82- ヽ4ect No/Date:12/82- ALC4/2014 ALC4/2014 10.12.2014 HQ File :01/82/050/00583/AM15/ Decision : ln the ‖ght of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/58/2011/Ch !l dated 15.12.2014′ it was decided to rat:fy norms under Para 4.7 of HBP vl as per details g市 en below or as applied by the nrm′ is less: Export Product Export Quantity S.No lmport Product Quantity Allowed Vlethyl Heptine Carbonate l kg 1. l-Heptyne Technical 0.890 kg 2. 1-Pentano1/N― Amyl Alcohol 0.805 kg may take appropriate action as per the decision of Norms Committee Defer Date: HQ File ParけName:KOPRAN LIヽ41TED RLA File Meet No/Date:12/82- ALC4/2014 10.12.2014 Lic.No/Date:0310775960 1Defer :01/82/050/00398/AM15/卜03'4/040/01160/AM14/26.03.2014 囲 Date:12.01.2015 Party Name:BEST VALUE CHEM PVT. :34/24/040/00299/ANI114/ Lic.No/Date:3410039647 25.03.2014

Case No.:81/5/82‐

ALC4/2014 Status:Deffered ision : It was decided to defer the case for 1 2.01 .20 I 5 for comments of Department of

Case No.:82/5/82¨

ParサName:KOPRAN LIヽ41TED Status:Deffered ALC4/2014 10.12.2014 Decision : It was decided to defer the case for 12.0 I .20 I 5 for comments of Department of Pharmaceuticals. It was decided to deferthe case for 12.01.2015 for comments ofIDepartment of S. Mcet No/Date:12/82- ALC4/2014 us:Deffered nd Re-indexed 毬

Case No.:57/10/82‐

Mcet No/Date:12/82- Status:Deffered ALC4/2014 Name:AUROBINDO PHAM LIMITED 10,12.2014 Party Name:JINDAL DRUGS LIヽ41TED ICase No.:51/5/82‐ 30 10.12.2014 プ TD. File Re-indexed No/Date:12/82- Re-indexed 10775954 12.01.2015 Re-indexed 10059640 ′ AM14/127.03.2014 12.01.2015

HQ File RLA File fi t I 821 O5O I 003 68iAM I 5 I i:03 19 4 I 040/0 1 098/AM 1 4 I 127 .03 .20 | 4 O""iiioo : It was decided to defer the case for I 2.0 I .20 I 5 for comments of Department of Pharmaceuticals. ParサName:KOPRAN LIMITED ヽ4eet No/Date:12/82- ALC4/2014 10.12.2014 師甍雇 :λi36:lMiζ 既蕊蔦語蔦 =IT閉 習雰T雨而面而 B施12.01.'115 1061133):50/00512/Av15/115蓼 ]:0/00606/AM14/F:蕊電P再 「Ⅸ荘覆百戻西】 [;it12012015 Paty Name:NEULAND LABORATORIES LTD Pharmaceuticals.

Case No.:48/5/82‐

ALC4/2014 Status:Deffered and Re-indexed

Case No.:110/6/82‐

ALC4/2014 Status:Deffered

Case No.:56/10/82-

ALC4/2014 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011123812014'PI(Norms) dated 10.10.2014 and in consultation with technical authority present in meeting, decided to ratifu norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- 107 Export product Exp. Qty. SI.No. lmport items Qty. AIlowed Kqノka (lS,4R)-4¨ [(2-AMINO‐ 6¨ CHLORO¨ 5-FORMAMIDO-4‐ PYRIMIDINYL)AMINO]‐2- CYCLO PENTENE‐ 1‐ METHANOL l kg N‐(2‐AMINO‐4,6- DICHLORO‐ 5- PYRIMIDINYL) FORMAMIDE 0.764 2 (+)-2- AZABICYCLO[2.2.1]HEPT‐ 5-EN‐ 3‐ ONE(VINCELACTANl) 1.41 3 D(―)TARTARIC ACID 0.78 4 SODIUM BOROHYDRIDE 0.226 5 ISOPROPYL ALCOHOL 4.70 6 METHANOL 4.23 7 L(+)TARTARIC ACID 1.23 31 0.12.2014 10776087 12.01.2015 Re‐lndexed く υ ハ υ No/]Date:12/82¨

RA concerned may take further necessary action as per above decision of NC.

Case No.:40/10/82¨

108 器 3掲5υ00954ハMy陽;翔濡屁蔦万踊淑膏画面面 B鳶12劇.2創5 Status:Deffered and Re-indexed uticals. Meet No/]Date:12/82- Deffered IALC4/2014 and Re-indexed 10.12.2014 Lic.No/Date:09100596781Defer :01/82/050/00514/AM15/1:09'4/040/00658/AM14/28.03.2014 Date:12.01.2015 Decision : [t was decided to defer the case for 12.01 .20 I 5 for comments of Depart;ent of Pharmaceuticals. Pa●y Name:DIVIS LABORATORIES LTD., ParサName:KOPRAN LINIIITED Meet No/Date:12/82- ALC4/2014 10.12.2014 LicoNo/Date:0310776372 1Defer :01/82/050/00361/AM15/:03/94/040/OH57/AM14/'8.03.2014 :12.01.2015 112 Decision : It was decided to defer the case for 12.01.201 5 for comments of Department of Pharmaceuticals. Mcet No/Date:12/82‐ tus:Deffered ALC4/2014 Re-indexed Lic.No/Date:03107763511Defer :0 1 I 82 I 050 I 003 64 I AMl 5 I t:03 t9 4 I 040 I 0 | t 69 I AMl 4 I 128.03 _20 | 4 Date:12.01.2015 Pany Name:SATYADEVA PHARMACEUTICALS Decision : It was decided to defer the case for 1 2.01 .20 I 5 for comments of Department of Pharmaceuticals. 器島掲50/00922/AM15/1鷺ち刷:υ0065νAMИ/ロギ究 "α 09100596848章 12.∝.2015

Case No.:52/6/82…

ALC4/2014 0

Case No.:112/6/82-

Case No.:44/5/82‐

ALC4/2014 Status:Deffered

Case No.:47/5/82-

Party Name:KOPRAN 10.12.2014

Case No.:8/10/82-

ALC4/2014 Mcet No/Date:12/82- Status:Deffered Meet No/Date:12/82- ALC4/2014 「 Party Name:UPL LTD. Re-indexed Re-indexed File File File : It was decided to defer the case for I 2.0 1 .20 1 5 for comments of Department of 14

Iro.tz.zot+ ision:It was decided to deferthe case for 12.01.2015 for comments ofI)epartment of &PC. No.:73/5/82‐ :Deffered Re-indexed Status:Deffered and Re-indexed ALC4/2014 Pharmaceuticals. 榊罫諄鮒~ HQ File RLA File Lic.No/Date:0910059694 1Defer :0 I I 82 I 0 5 0 I 0096 I /AM 1 5 I l:09 124 I 040/0063 8/A Mr 4 I 102.04.20 t 4 Date:12.01.2015 I)ecision : It was decided to defer the case for 12.01.2015 for comments of Department of Pharmaceuticals. Pa町 Status:Deffered IName:BIOLOGICAL E IALC4/2014 LTD 10.12.2014 Decision : It was decided to defer the case for I 2.0 I .20 I 5 for comments of Department of Pharmaceuticals. Pany :Deffered Name:BIOLOGICAL E IALC4/2014 nd Re-indexed LTD 10.12.2014 : It was decided to defer the case for 12.0 L20 I 5 for comments of Department of ticals. HQ File RLA File Lic.No/Date:0910059697 1Defer :01/82/050/00936/ANI11 5/1:09/24/040/00669/AM14/ 103.04.2014 Date:12.01.2015

Case No.:47/10/82‐

ALC4/2014

Case No.:4/10/82‐

ALC4/2014 and Re-indexed

Case No.:15/10/82‐

ALC4/2014 Case No。:22/10/82… ALC4/2014 33 File ANAM PVT.LTD. 10.12.2014 10.12.2014 AM l s/ l:$1951040101 043/AMl 41 1,01.04.2014 No/Date:12/82- 12.01.2015 12.01.2015 12.01.2015 12.01.2015 Re-indexed File 1/82/050/00390/ANI11 5/ 1189/AM14/ No/Date:12/82- No/Date:12/82‐ NalneiOGENE No/Date:12/82‐ INDIA PVT. 4

Case No.:67/5/82-

ALC4/2014 Pa●y Name:FDC LTD H9鵬 島児5γ0038仏myl鵬 艦 υ∞∞鳳Ⅲyl認 需 α “ Ю η %∬ B諸12].知 5 Status:Deffered ALC4/2014 10.12.2014 and Re-indexed Decision : It was decided to defer the case fo, f Z.O f : Pharmaceuticals. Mect No/Date:12/82- nd Re-indexed NIleet No/Date:12/82‐ ALC4/2014 Decision:Itwasdecidedtodeferthecaseforl2.0l.z0rsfoi.@ Pharmaceuticals. ALC4/2014 10.12.2014 Status:Deffered and Re-indexed Decision : It was decided to defer the case for 12.01.2015 for comments ;aa"p..tr"rt "f Pharmaceuticals. Mcet No/Date:12/82- ALC4/2014 |:3:〕):50/00382/AM15/ 1飩悩蔦 悧辮憫Юη賀"肝

Case No.:72/5/82‐

ALC4/2014 Party Name:GLOBE TROTTERS PVT LTD ALC4/2014 10.12.2014 隔蔦蕊萬誌1翻器α“Юηη %B席 12劇2m5

Case No.:23/6/82‐

Patty Name:KUDOS Status:Deffered 10.12.2014

Case No.:24/6/82¨

ALC4/2014 Party Name:KUDOS CHEヽ(IE LTD., Case No。:65/5/82- ALC4/2014 Party Name:CROWN CHEMICALS PVT.LTD., 110.12.2014 Decision : Committee considered the case as per agenda and in the light of earlier decision taken by NC in its 6/82 meeting dated 29.08.20L4, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Piperonal Min. Purity 98o/o Dichloromethane (Min. Purity 0.875 kg 。lhl 34 No/Date:12/82- Re-indexed :It was decided tO deferthe case for 12.01.2015 for comments OfDepartment of CHEMIE LTD., No/Date:2210014787 107/AM14/Ю9.04.2014

Hexamine (Min. Purity 90%) 1.000 kg 5. Toluene(Mln.Pu画ty 97%) 0.430 kg 6. lsopropyl Alcohol(Min.Puttty 990/0) 0.220 kg may take appropriate action as per the dccision ofNollllS COmmittee.

Case No.:66/5/82‐

ParりName:CROWN CHEMICALS PVT.LTD., ALC4/2014 10.12.2014 HQ File :01/82/050/00383/Aヽ415/ RLA File :03/94/040/00005/AM15/ 124 Ｆ Ｌ Ｆ Ｉ ParりName:CADILA HEALTHCARE LTD., Lic.No/Date:0810130534 1Dcfer :08/24/040/00008/AM15/111.04.2014 Date:12.01.2015 Pharmaceuticals. Ｆ Ｌ Ｆ Ｉ Ｆ ‐ ‐ ２ ７ ‐

Case No.:68/5/82‐

ALC4/2014 Decision : Committee considered the case as per agenda and in the light of earlier decision taken by NC in its 6/82 meeting dated 29.08.2OL4, it was decided to ratify norms under Para 4.7 of HBP vL as per details given below or as applied by the firm, whichever is less: Export product 恥 Ｑ ｔ ｖ ． SI.No. lmport items Qty. a‖owed Piperonal Min. Purity 98% l kg Catechol(Min.Pu面ty 99%) 0.862 kg 2. Dichloromethane(Min.Puttty 990/0) _ 0。703 kg 3. DimethylsurOxide(Min.Puttty 99%) ____ 0,875 kg 4. Hexamine(Min.Pu面ty 96%〕 1.000 kq 5. Toluene(Min.Punty 97%) 0.430 kq 6. lsopropyl Alcohol(Min.Puttty 990/0) __ 0.220 kg

Case No.:1/2/82‐

Meet No/Date:12/82 Status:Deffered Status:Deffered and Re-indexed ALC4/2014 10.12.2014 luq rite IRLA File lLic.No/Date:03 I 0778 I 4O jOeter 14 No.:32/5/82‐ Name:EMCURE No/】Date:12/82‐ Re-indexed Re-indexed : It was decided to defer the case for I 2.01 .20 I 5 for comments of Department of No/Date:12/82‐

‐ l:0 t I s2/ 05 0 1003 8 5/AM l 5 I l:$ D a fi40 I O | 125 I AM I 4/ I I t .04.20 t 4 lDate:12.01.2015 : It was decided to defer the case for 12.01 .2015 for comments of Department of icals. PaゥName:ALEMBIC Mcet No/Dttα 12/82- Deffered PHARMACEUTICALS iALC4/2014 Re-indexed 10.12.2014 Lic.No/Date:3410039800 1Defer :0 I I 82 I 050 I 003 5 I /AM I 5 / i:3 4 124 I 040/00003/AM 1 s I il 5 .0 4 .20 1 4 Date:12.01.2015

Case No.:39/8/82-

PaゥName:MYLAN IMeetNo/Dttα 12/82‐ ALC4/2014 Decision:It was decided to deferthe case for 12.01.2015 for comments ofIDepartment of Meet No/Date:12/82- ALC4/2014 10.12.2014 LABORATORIES LIMITED ALC4/2014 10.12.2014

Case No.:27 tslSz- -@@Ft"tr-

ALC4t2Ot4 iprmnVeCEUTrCALS ieLC+tZOA lapproved lrro lro.tz,.zor+ I HaFn" ry@E"r*- :011821050100344/AMl5l i:341241040/00006/AMl s/ 1t5.04.2014 lDate: Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 350111329/2014-PI(Norms) dated December 2014 and in consultation with technical authority present in meeting, decided to ratifu norns under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- 128 Export product 賄 韓 SI.No. Import items Qty.A1lowed kg Dn77idime (Cefetamet Pivoxil Hc1 500 mg tabs) l kg l Cefetamet Pivoxil Hydrochloride 510 mg/500 mg tablet And 255 mg/250 mg tablet

Case No.:34/5/82¨

ALC4/2014

Case No.:21/10/82‐

ALC4/2014 IName:BIOLOGICAL E Re-indexed 12.01.2015 Ｆ Ｌ Ｆ Ｉ File 5/116.04.2014 Ｆ Ｉ Ｉ Ｉ Ｉ ト ー

Case No.:69/5/82¨

Party Name:FDC LTD : It was decided call from the firm a copy of Certificate of Analysis of export product COA).The Case is deferred for 12.01.2015. ヽ4eet No/]Date:12/82¨ Deffered ALC4/2014 Re…lndexed 10.12.2014 Lic.No/Date:0310778812 1Defer :0 I I 82 I 050 I 003 86/AM I 5 I I :$ /9 4 I 040/0004 I /AM I 5 I lzt .0 4.20 1 4 Date:12.01.2015 icals. Status:Deffered and Re-indexed Lic.No/Date:0310779054 1Defer :01/82/050/00395/AM15/1:03/94/040/00012/AM15/122.04.2014 Date:12.01.2015 Decision : It was decided to defer the case for I 2.0 I .201 5 for comments of Department of Pharmaceuticals.

Case No.:48/10/82-

Patt Name:MYLAN IMeetNo/Date:12/82‐ Status:Deffered and Re-indexed ALC4/2014 LABORATORIES ALC4/2014 10.12.2014

Case No.:58ノ10/82‐

Case No.:78/5/82-

ALC4/2014 Status:Deffered LABORATORIES 朧 霊|』llldecidedtodeferthecasefbr12.01.2015 for comments ofI)epartment of PartyName:MYLAN lMeetNo/Date:12182- : It was decided to defer the case for I 2.0 I .20 I 5 for comments of Department of ALC4/2014 10.12.2014 :]Deffered Re‐lndexed Status:Deffered and Pharmaceuticals. 剛 需腸 ツ 10/82‐ 鴇 漁 器 ERO匿 棚 T引 2/82- KuMAR ICase No.:49ノ10/82‐ 篤 File 1/82/050/00935/Aヽ/115/ AM14/121.04.2014 File No/Date:12/82- LIMITED 110.12.2014 Namc:IPCA Re-indexed File 1/82/050/00962/Aゝ/115/

Iro.tz.zot+

Case No.:77/5/82‐

ParりName:INDOCO REMEDIES LllИITED Decision : It was decided to defer the case for 12.01.2015 for comments of Departmeni of Pharmaceuticals. Meet No/Date:12/82- Status:Deffered ALC4/2014 and Re-indexed 10.12.2014 Decision : It was decided to defer the case for 12.0 L20 I 5 for comments of Departmeni of Pharmaceuticals. ParけName:LINIMAX CHEMICALS PVT LTD. HQ File Lic.No/Date:0310779156 1Defer :011821050/003 70lAM I 5 I l:$ t95 tOa0l000 1 5/AM I s/ lZl .O+ .ZOt q Date:12.01.2015 ision : It was decided to defer the case for 1 2.01 .20 I 5 for comments of Departmeni of rmaceuticals. PaゥName:EMCURE IMeetNo/Date:12/82‐ Status:Deffered PHARMACEUTICALS iALC4/2014 nd Re-indexed 10.12.2014 n : It was decided to defer the case for 12.01.201 5 for comments of Department of Pharmaceuticals. 器 3児5υ∞ 540/AⅢy隔瓢1話孤百1蹴鼎副Ю %3590瞬蕊蔦 141 器航5γ00323/AMly陽危刷iυ90034ハMl:/閉:∬究Tα 05103848Ю B鳶12劇.2∝5 10.12.2014 ParサName:UNITED BIOTECH PVToLTD. Mcet No/Datc:12/82¨ Status:Deffered ALC4/2014 and Re-indexed Pharmaceuticals. Pany Name:BRUNDAVAN LABORATORIES PRIVATE LTD。, Decision : It was decided to defer the case for 12.01.2015 for Pharmaceuticals.

Case No.:53/5/82‐

Status:Deffered ALC4/2014 10.12.2014

Case No.:6/5/82-

ALC4/2014

Case No.:53/10/82-

Meet No/Date:12/82‐ Status:Deffered ts of Department of ′ 12.01.2015 12.01.2015 Re-indexed Re-indexed 12.01.2015 File 1/82/050/00394/AM15/ ′TD. 10.12.2014 No/Date:12/82- No.:138/6/82‐ 前 ゛ 岬 ふ1愉e 螂 眸 Udy●g ttha"an`

ffi- IlCasexo.,zllolgz--ffilMeetNo/Date:l2l82-|Status:Deffered| I l.ucllzorc lLasoRAroRIES LTD., lALC4l2014 land Re'indexed I I I I lto'r2'2014 I I lr+rffiffi@P"f* i I I,OVgZtOsOtOo4T6tAMtv l:091241040/ooOr4/AMls/tzs.o+.zot+ lDate:12.01.201s i l, ::;l lffiedtodeferthecaseforl2,0l.20l5forcommentsofDepartmentofl I lPn"t uceuticals. Ｆ Ｌ Ｆ Ｉ ｄ ｄ ｈ ｄ ｅ ｘ ｅ ｅ 　 ｎ 耐 Ｒ ｅ ． ｉ Ｆ Ｌ Ｆ Ｉ Status:Deffered and Re-indexed indthefirmtofurnishacopyofDML(DrugManufacturing Licence). The case was deferred for 12.01 .2015.

Case No.:8/5/821 "att Name:MOREPEN IMeaNo/Dttα 12/82-

tus:Deffered LABORATORI ES LTD.,',ALC4I}OI 4 and Re-indexed Decision:It was decided to defer the case lor 12.01.2015 for comments ofI〕epartment of PaゥNamcSURVⅣAL IMeetNo/Dttα 12/82‐ Ft"twD.ff"*d land Re-indexed I TECHNOLOGIES IALC4/2014 器晶児5γ∞賀νAtty脇監 OЮ∞26/A叩ダ1瑚器 α “ Юη%“ 囲 2劇ふ15 Decision : It was decided to defer the case for 12.0 I .201 5 for comments of Department of PC. NIlect No/Date:12/82- ALC4/2014 10.12.2014 111;危:λ:0/00 Lic.No/Date:0910059852 1Defer :01/82/050/00955/AM15/:09/24/040/00028/AM15/125.04.2014 Date:12.01.2015

Case No.:63/5/82-

ALC4/2014 1常 "盤 Υ

Case No.:64/5/82‐

ALC4/2014

Case No.:41/10/82‐

Party Name:VIVIMED LABS LIヽ41TED : It was decided to defer the case for 12.01.2015 for comments No/Date:12/82- 12.01.2015 10.12.2014 12.01.2015 No。:46/10/82- Name:VIVIMED No/1Date:12/82- LIMITED 14 Re-indexed 10.12.2014 12.01.2015 KUMAR 39 一 頭 ﹈ 10n Trad0

50鵬 星帰5剛%5晨Ⅲy陽 ち蔦 蕊 薦 万 1翻 鼎 α酬 ∞ "田 7B度 12劇洲 5 lf謎 胤 留 /1°/82- PC. &PC. Pa“y Name:VIVIMED LABS LIMITED Status:Deffered and Re-indexed : It was decided to defer the case for 12.01.2015 for comm.ntr of b.pu.trn*t or Status:Deffered ALC4/2014 10.12.2014 and Re-indexed : It was decided to defer the case for 12.0 L20 I 5 for comments of oepartmeni oT Status:Deffered nd Re-indexed : It was decided to defer the case for 12.01.201 5 for comments of Department of uticals. R4eet No/Date:12/82- ALC4/2014 10.12.2014 us:lrenered Re-indexed Lic.No/Date:2210014839:Defer :0 t I 82 I 0 5 0 I 00990/AM I 5 I l:22 I 24 I 0 40 I OOO99 I AMt 4 I 1,29 .O 4 .20 t 4 Date:12.01.2015 : It was decided to defer the case for 12.01 .20 I 5 for comments of Department of Pharmaceuticals. Party Meet No/Date:12/82- Status:Deffered IName:METROCHEM IALC4/2014 and Re-indexed APIPVT.LTD. 10.12.2014 Paty Name:NECTAR IMeetNo/Date:12/82‐ Deffered 棚 児50Ю "0独 剛y腸ち臆 OЮ剛独Ⅲyl淵 鼎 α "Ю ∝ "Ю B鳶12劇2m5 1521HQ File 扁 LIFESCIENCES LIMITED, ALC4/2014 10.12.2014 and Re-indexed Date:12.01.2015 申 酬 岬 握 諄♯~

Case No.:51/10/82‐

Paty Name:VIVIMED LABS LIMITED

Case No.:43/8/82‐

Case No.:76/10/82-

ALC4/2014 Pa●y Name:KUDOS CHEMIE LTD.,

Case No.:75/8/82‐

ALC4/2014

Case No.:77/10/82-

ALC4/2014 籾 File No/Date:12/82- ion Trade Name:COVALENTlMcet No/Date:12/82- ATE LIMITED l10.12.2014 15/129.04.2014

: It was decided to defer the case for 1 2.01 .20 I 5 for comments of Department of

Case No.:61/10/82-

PaゥName:STERLING IMcetNo/Dtte:12/82‐ 常 IЫAⅢESPVT I常 "盤 Υ HQ File Lic.No/Date:0310779831 1Defer :01/82/050/00975/AM15/1:03/95/040/00913/Aヽ /114/ 129.04.2014 Date:12.01.2015 Decision : It was decided to defer the case for 12.01 .20 I 5 for comments of Department of : us:Deffered nd Re-indexed : It was decided to defer the case for 12.01 .20 I 5 for comments of Department of ticals. Mcct No/Date:12/82- ALC4/2014 10.12.2014 RLA File Lic.No/Date:0310780255 1Defer :01/82/050/00320/AM15/1:03/95/040/00017/AⅣ l15/101.05.2014 Date:12.01.2015 Mect No/Date:12/82- ALC4/2014 10.12.2014 HQ File Lic.No/Date:0910059967 1Defer :01/82/050/00933/AM15/1:09/24/040/00020/AM15/Ю l.05.2014 Date:12.01.2015 D".t.'t". t ft r""r d" .r""tr "f D.p".tr*t "f Pharmaceuticals. Pharmaceuticals. 鵬 月W∞%7AMy陽 ち鵬 剛 ∽鳳Ⅲy躍 鼎 α酬∞ "%8B荒 12m2m5 Party Name:DHANUKA LABORATORIES LTD. ― Status:Deffered and Re-indexed Status:Deffered Decision : It was decided to defer the case for 12.01 .2015 for comments of Department of

Case No.:19/10/82-

Case No.343/10/82-

Party Name:SRINI PHARMACEUTIC Status:Deffered

Case No.:9/5/82‐

Status:Deffered luq rite iRL,q. r'le I lLic.No/Oate:05 I 03 85706 File No.:20/10/82¨ Re‐EndeXed Re-lndexed Re-lndexed No.:3/5/82- Party Name:NEW DYE― Name:SRINI No/Date:12/82- Re-indexed

@@Fos:ot+ lDate:12.01.2015 Decision : It was decided to defer the case for 1 2.0 I .20 I 5 for comments of Department of Pharmaceuticals. Decision : It was decided to defer the case for I 2.0 I .20 I 5 for comments of Department of Pharmaceuticals. ParサName:DHANUKA LABORATORIES LTD. ParサName:NEW ALLIANCE DYE‐ ParサName:NEW ALLIANCE DYE¨ Mect No/Datei1 2/82- ALC4/2014 10.12.2014 :Deffered Re-indexed NIteet No/Date:12/82- ALC4/2014 Deffered Re-indexed Meet No/Date:12/82- Status:Deffered IALC4/2014 and Re-indexed ICHEM PVT.LTD., 110.12.2014 Lic.No/Date:0310780621 1Defer :0U82105010037l/AMls I l:$l9sfia0/00077/AMl5/ 10s.05.2014 Date:12.01.2015 Decision : It was decided to defer the case for 1 2.0 I .20 1 5 for comments of Department of 脇監0岬∴。 庶ダ
囲 ']洲 5 CHEM PVT.LTD., 110.12.2014 NIleet No/1Date:12/82- ALC4/2014 10.12.2014 悧器α“Ю賀""開 :01/82/050/00327/AM15/ :05/23/040/00015/AM15/ Decision:ln the iight of written comments received from Department of Pharmaceuticals vide their OM No.35011/291/2013-PI(Norms)dated 01.04.2014′ it was decided to raJfy norms under Para 4.7 of HBP vl as per details given below oras app‖ ed by the firm′ whicheveris:ess: Export Product: Atorvastatin Tablets 5mg and l0 mg S.NO. lmport ltems :or export of 1 No. tablet (Qty in ns) 5 mg L0mg 1. Atorvastatin Calcium 5.42 10.84 2. Microcrystalline Cellulose (PH- 101) 12.48 8.66 3. Calmellose Calcium (ECG 505) 16.00 20.0 4. Hydroxypropylcellulose (SSL) 0。70 1.0

Case No.:12/5/82-

Case No.:54/5/82‐

Case No.:57/5/82-

ALC4/2014

Case No.:10/5/82-

Paty Name:JUBILANT LIFE SCIENCES LIMITED 12.01.2015 1/82/050/00329/AM15/ File File File

5 MaBpes um Oxide(XP-103) 15.0 16.0 6. Maqnes um Oxide JP 8.0 30.0 7. Microcrystalline Cellulose(KG― 1000) _ 2.0 8. Masnesium stearate 0.40 0.50 9. Methvlene Chloride 45.0 61.0 10. Anhydrous Ethanol 5.0 16.0 may take appropriate action as per the decision of Norms committee. Decision:It was decided to defer the case for 12.01.2015 for comments of Department of Pharmaceuticals. HQ File Datc:12.01.2015 :0 t I 821 050 I 003 3 0/AM 1 5 I l:05 l24l 040 I 00049 I AM I 5/ 109.0s.20 I 4 Decision:It was decided to deferthe case for 12.01.2015 for comments ofIDepartment of Pharmaceuticals.

Case No.:13/5/82-

ALC4/2014 Mcet No/Date:12/82‐ 10.12.2014 IName:PARABOLIC DRUGS LTD.,

Case No.:15/5/82‐

Case No。:21/5/82- ALC4/2014 鵬 晶児5υ∞ "ν AM y膨 鵬 υ∞ “ りAMyl認 器 αいЮ賀 “ %B鳶 12劇2m5 Pany Name:PARABOLIC DRUGS LTD., RLA File :05/24/040/00053/AM15/ Status:Deffered and Re-indexed Defer Date:12.01.2015 Pharmaceuticals ParけName:RECKITT BENCKISER HEALTHCARE INDIA LIⅣIITED HQ File :01/82/050/00334/AR415/ Lic.No/Date:0510386224 09.05.2014 Ｆ Ｌ Ｆ Ｉ No.:35/5/82- Name:ELIXIR No/Date:12/82‐ Re¨Indexed 10.12.2014 AM15/107.05.2014 12.01.2015 PaJy Re-indexed No/1Date:12/82‐ 4 Re-indexed AM15/09.05.2014 12.01.2015 : It was decided to defer the case for 12.01.2015 for comments of Department No/Date:12/82‐ 4 10.12.2014 No.:17/5/82- No/Date:12/82- 4 Re-indexed 10.12.2014

:Itwasdecidedtodeferthecaseforl2.0l.20tsro'"o..ffi ,uticals

Case No.:18/5/82‐

ParサName:RECKITT BENCKISER Ⅳ〔eet No/Date:12/82- IALC4/2014 10.12.2014 Decision:Itwasdecidedtodeferthecaseforl2.0l.20ts Pharmaceuticals and Re-indexed Decision : It was decided to defer the case for 12.01.2015 for .o-rn"nii of O.pu.tr*"t of Pharmaceuticals Pa●y Name:RECKITT BENCKISER HEALTHCARE INDIA LIⅣIITED Status:Deffered ALC4/2014 10.12.2014 R4eet No/Date:12/82¨ Status:Deffered ALC4/2014 10.12.2014 曖 and Re-indexed : It was decided to defer the case for 12.01 .2015 for comments of Department of Patty Name:SATYA DEEPTHA PHARMACEUTICALS Paty Name:SATYA DEEPTI‐IA PHARNIACEUTICALS LTD h4eet No/Date:12/82- ALC4/2014 10.12.2014 Status:Deffered and Re-indexed 173 躙 児5υ∞%鳳Ⅲy陽ち漏精ν∞%νAM y圏 器 酬Я ∞ “ “ 2B鳶 12劇洲 5 Decision : It was decided to defer the case for 12.01 .2015 for comments of Department of Pharmaceuticals Mcet No/Date:12/82‐ Status:Deffered ALC4/2014 and Re-indexed 10.12.2014 Defer Date: I 2.01 .20 I 5 ision : It was decided to defer the case for 12.01 .2015 for comments of Status:Deffered

Case No.:19/5/82-

ALC4/2014

Case No.:18/10/82…

Case No.:37/10/82…

ALC4/2014

Case No.:17/10/82¨

Party Name:HETERO LABS LIIИITED Pharmaceuticals 44 搬割搬檬親 :l No/]Date:0510386217 AMr 5/ 109.0s.2014 η Re-indexed 12.01.2015 12.01.2015 No/Date:12/82- Of

Party Name:MYLAN LABORATORIES

Case No.:5/10/82¨

ヽ4cet No/Date:12/82 ALC4/2014 10.12.2014 ALC4/2014 Defer :12.01.2015 ffith""u'.forl2.0l.20l5forcommentsofDepartmentof Pharmaceuticals. tatus: pproved HQ File :01/82/050/00924/AM15/ Decision : It was decided to defer the case for I 2.0 I .20 I 5 for comments of Department of Pharmaceuticals Mcet No/Date:12/82‐ ALC4/2014 10.12.2014 HQ File :01/82/050/00948/AM15/1:09/24/040/00017/AM15/113.05.2014 Date:12.01.2015 ision : It was decided to defer the case for 12.0 I .201 5 for comments of Department of Pharmaceuticals tus:Deffered Re-indexed NMF 鎖 駆 軍、 Df嬰喜ま螺f義謂艶ト 彙鵠野廻1 蝦 lゴiaFI 壇躊 dい Status:Deffered

Case No.:10ノ10/82‐

ALC4/2014 Decision : ln the ‖ght of written comments received from Department of Chemicals and Petrochemicals vide the:rU.O No.14010/138/2011-Ch.‖ dated 09.12.2013′ it was decided to ratify norms under Para 4.7 of HBP vl as per details g市 en below or as applied by the nrm′ whicheveris less: Export product Exp. Qtv. Sl.No. lmport items Qty. allowed AVIS(AVOBENZONE) l kg 1 PARA TERTIATORY BUTYL BENZOIC ACID (PTBBA) 1.148 kg 2. ACETYL ANISOLE 0,929 kg 3. ACTIVATED CARBON 0.025 kg 4. SODAMIDE 0.206 kg 5. METHANOL 4.θθ kg 6. TOLUENE 1.00kg

Case No.:52/10/82‐

Status:Deffered

Case No.:34/10/82‐

ALC4/2014 LABORATORIES 巨ほ霊胤glυ8ト 45 Udy° 9‐もいび ● ′ Re-lndexed File 10060057 /82/050/00919/AM15/ AM14/112.05.2014 Name:VIVIMED No/Date:12/82‐ LINIIITED 10。12.2014 File 10060073 Date: 151 t12.05.2014 No/1Date:12/82- Re-indexed LIMITED 0.12.2014 File 10060080 5/113.05.2014 12.01.2015 Name:DR Re-indexed File 10060082 File No/Date:12/82‐

:It was decided to deferthe case fbr 12.01.2015 for comments ofI〕epartment of S

Case No.:44/10/82-

Pa●y Name:MYLAN IMcet No/Date:12/82- ALC4/2014 Deffered Re-indexed LABORATORIES LIMITED ALC4/2014 10.12.2014 Pharmaceuticals ParけName:NIYLAN IMeetNo/Date:12/82‐ Status:Deffered LABORATORIES LIMITED ALC4/2014 and Re-indexed 10.12.2014 Pharmaceuticals Paty Name:ASTRIX LABORATORIES LTD., ALC4/2014 10.12.2014 RLA File :09/24/040/00069/AM15/ Lic.No/Date:0910060121 15.05.2014

Case No.:59/10/82‐

ALC4/2014 Ⅲ 厩 悪 '0""/AMly陽 蹴 υ∞餌5ハⅢy圏 鼎 酬鈍∞ω ∝4B鳶 12劇洲 5 : [t was decided to defer the case for 12.01.2015 for comments of Department of HQ File :01/82/050/00925/AM15/ Decision :ln the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/78412o13-Pl(Norms) dated 09.09 .2074, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity S′No Item of lmport Quantity allowed ke/ke LAMIVUDINE (CYCLOHEXYL ESTER ROUTE) l kg 1. CYCLOHEXYL ESTER 2.19 2. SODIUM BOROIIYDRIDE 0。48 3. DIPOTASSIUM HYDROGEN PHOSPHATE 1.9849 4. METHANOL 0.167 5. TOLUENE 0.200 6. TRIETHYLANIIINE 0.575 7 ISOPROPYL ALCOHOL 1.427

Case No.:11/10/82‐

ALC4/2014 F膿 淵 ソ 1船卜 「 霞 緞3冊 灘 s aa NIleet No/Date:12/82- ALC4/2014 46 ・ t 7 / AMt 5 / i:09 t24to40 I 00065 I AM I 5/ i I 3 .05.20 1 4 File 1/82/050/00958/AM15/ 15/113.05.2014 No/Date:12/82‐

IroJz.zor+ Defer Date:12.01.201 5 t ti *ur decided to defer the case for 12.01.2015 for comments of Department of Pharmaceuticals Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011122212014-PI(Norms) Ol.lzj}l4 and in consultation with technical authority present in meeting, decided to ratifr norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- [A] For Export of Rocuronium Bromide Iniection 10ms/ml.5ml Vial USP------------lNo. S.No. Import Item (1) Norms Applied ol As per Central Excise Certificate (3) Batch Logsheet (4) Lowest of (2)to (4) (5) 1 RCB Diol 71.5rng As per S10N 57.75mg 2 Glass Vials 1.064nos. 1.0617 1.0565 1.0565nos Ｏ Ｄ Rubber Stoppers 1.076nos. 1.0832 1.0794 1.076nos 4 Seals, Plastic and Rubber 1.064nos. 1.048 1.0310 1.031nos 5 Sodiunl chioride 13P 0.000022kR Excipients & Consumables. Relevant, Net to Net 6 Benzvl alcohol BP 0.0000441it 7 Sodiunl hvdroxide l」SP 0.0000001kg 8 Hydrochloric USP 0.00000041it 9 Tubine, Plastic 0.0006731it 0 Filters.Plastic 0。000181nos. 1 Anti factor xa test kits 0.000101nos. 2 Anti factor lla test kits 0.000101nos. 3 Analytical columns 0.000022nos. 14 Analyical guard columns 0.000022nos. :- These norrns are specific to US FDA project. The higher nonns for packing materials be permissible only in respect of export to USA and will not be applicable on repeat basis. [B] For Exnort of Rocuronium Bromide Iniection l0me/ml. 10ml Vial USP-----------1No. S.No. lmport Item (1) Norms Applied o
As per Central Excise Certificate (3) Batch Logsheet (4) Lowest of (2)to (4) f5) 47 File 110063976 AMI 5/ Bt l$fia0100035/AM I 5/ i I s.0s.2014 No.:25/10ノ82‐ Name:GLAND No/Date:12/82‐ LIMITED File 10060107 AM15/ AM15/ 115.05.2014 TD. 10.12.2014

1 RCB Diol 142m2 As per SIC)N 115.5mg 2 Glass Vials 1.07nos. 1.0927 1.0922 l.07nos 3 Rubber Stoppers 1.10nos. 1.1067 1.1053 1.10nos 4 Plastic Seals 1.05nos. 1.0643 1.0413 1.0413nos Sodium chloride 0.000022kg Excipients & Consumables. Relevant, Net to Net 6 Benzyl alcohol 0.0000441it 7 Sodium hydroxide 0.0000001kg 8 Hydrochloric 0.00000041it 9 Tubing 0.0006731it 10 Filters 0.000181nos. Anti factor xa test kits 0.000101nos. 12 Anti factor lla test kits 0.000101nos. り ， Analytical columns 0.000021nos. 14 Analyical guard columns 0.000021nos. [9:- These norrns are specific to US FDA project. The higher norrns for packing materials ll be permissible only in respect of export to USA and will not be applicable on repiat basis. may take appropriate action as per the decision of Norms committee.

Case No.:39/10/82¨

Paty Name:MYLAN LABORATORIES Mcet No/Date:12/82‐ 10.12.2014 HQ File RLA File Lic.No/Date:0910060145 1Defer :01/821050t009s3/AM I 5 I l:09t24t040/00060/AM tst lls .os .2014 Date:12.01.2015 aceuticals ParサName:PuGNA IMcet No/Date:12/82- tatus:Deffered HQ File INTERNATIONAL LTD. RLA File ALC4/2014 10.12.2014 Lic.No/Date:0310781971 Defer Re-indexed Date:12.01.2015 :01/82/050/00503/AM15/:03/95/040/00122/AM15/119.05.2014 Status:Deffered

Case No.:101/6/82‐

ALC4/2014 Decision : It was decided to defer the case for 12.01 .2015 for comments of Department of &PC. Mcet No/Date:12/82- HQ File RLA File Lic.No/Date:0310782171 1Defer :01/82/050/00784/Aル115/ :03/94/040/00H1/AⅣl15/120.05.2014 Date:12.01.2015 ヽ4eet No/]Date:12/82‐ ALC4/2014 10.12.2014 Status:Deffered HQ File :01/82/050/00355/AM15/ Comm6rce RLA File :08/24/040/00076/Aヽ415/ 織 臨 聴1朧鷺珈 亀 : 48 ICase No.:120/8/82… Pa●y Name:INDOCO Status:Deffered ALC4/2014 10.12.2014 Case No。:38/5/82… Party Name:INTAS PHARMACEUTICALS LTD., Lic.No/Date:0810131456 120.05.2014 明熱臨蔦灘l nd Re-indexed V 4 Re-indexed Re-indexed LINIIITED : It was decided to defer the case for 12.01 .20 I 5 for comments of Department of 188 |、暴 :L ど ず豫麗誉βボ

Pharmaceuticals

Case No.:9/10/82‐

ALC4/2014 P"rtyN"..fN,ICURE @ Status:Deffered PHARNIACEUTICALS IALC4/2014 10.12.2014 Mcet No/Date:12/82- ALC4/2014 10.12.2014 鵬 児 "Ю"郎 晨my臨 荒 υ∞ “ νAM y孵 器 αtt Ю%舶餌 B鳶12m2m5 HQ File :01/82/050/00920/ANI115/ RLA File :05/23/040/00067/ANI11 5/ タギ辮m舒"8「 190 Decision : In the light of earlier decision taken by NC in its l/AMl5 meeting dated2 it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or by the firm, whichever is less: [1f Export Product : Enrofloxacin Flavored Tablets 22.7 mg S.NO. lmport ltem Quantity recommended for 1 No. of tablet 1 Enrofloxacin 23.154 mg tablet 2. Art:ficial Powder Beef Flavor 79.282 mg [2] Export Product: Enrofloxacin Flavored Tablets 68 mg S.NO. lmport ltem Quantky recommended for l No.of tablet 1 Enrofloxacin 69.36mg 2. Artificial Powder Beef Flavor 237.5 mg [3] Export Product: Enrofloxacin Flavored Tablets 136 mg S.NO. lmport ltem Quantity recommended for l No.of tablet 1 Enrofloxacin 138.72 mg tablet 2. Artificial Powder Beef Flavor 475 mgtab:et ParけName:ⅣnアLAN LABORATORIES LIⅣIITED にた。 No/Dtte:09100601661Deおr 1.04.2014, as applied fulel EtqxrNIRMAL KUMAR sq qgrRcr€ fr*qr aqrqrc Dy. Diractor Gen€ral of Foreign Trado fuic, zqrqY qrrRqrrmq Directorate G6n6ral of Foreign Trade glFrq ft{r.rDepartment ot c;mmerce sdrrr crcq. rii Rffi Udyog Bhawan, New Dethi and Re-indexed Decision : It was decided to defer the case for 12.0 I .20 I 5 for comments of Department of Pharmaceuticals

Case No.:6/10/82‐

ALC4/2014 Pa■y Name:JUBILANT LIFE SCIENCES LIMITED

Case No.:35/10/82‐

ALC4/2014 Status:Deffered ALC4/2014 10.12.2014 IHQ File lru-e rite 49 TD. No/]Date:12/82- Re-indexed Ｆ ト ト ー ー ー ー

IЮ 1/82/050/00949/AM15/IЮ 924/0191922z竺整:: pate:12.01.2o15 :It was decided to defer the case for 12.01.2015 for comments ofI)epartlnent of )uticals Party Name:MYLAN Mcet No/Date:12/82- ALC4/2014 10.12.2014 LIMITED ffi case for lz.ol.zol5 for comments of Department of icals NIlect No/Date:12/82‐ ALC4/2014 10.12.2014 HQ File RLA File Lic,No/Date:0310782487 :01/82/050/00622/ANI11 5/ :03/94/040/00122/AM15/ 122.05.2014 Decision : It was decided ffiOtS fo. comments of Department of ticals . .ur" for 12.01.2015 for comments of Department of ticals 開蕊 t It "r diaia to defer the case for 12.01.2015 for comments of Department of ticals Pany Meet No/Date:12/82‐ ALC4/2014 10.12.2014 : ln the light of Written comments received from Department of Chemicals and vide their U.O No. 14010/90/2011-Ch. ‖dated 19.11.2014′ it was decided to norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm,

Case No.:36ノ10ノ82-

Status:Deffered iCase No.:220/6/82-

Case No.:221/6/82-

Party Name:ANUH Status:Deffered IALC4/2014 PHARMA LTD.

Case No.:79/8/82‐

NIleet No/Date:12/82- Status:Deffered PHARNIIACEUTICALS INTERNAT10NAL

Case No.:115/6/82‐

ALC4/2014 IName:HINDUSTAN POLYAMIDES& FIBRES LINIIITED (Joyog orrawa. r. lYerv us.i rl 50 け Ｆ Ｉ Ｌ ド ー ー Re-indexed .05.2014 12.01.2015 Re-indexed File 10782489 1/82/050/00623/AM15/ 12.01.2015 Name:BDR Re-indexed .LTD. File File 1/82/050/00743/AM15/ File Party Name:ANUH

is less: Export product Export Quantity S.No. Import items Quantity AHowed HEXYL SALICYLATE l kg 1 n―HEXANOL 0.510 kg つ ん METI‐IYL SALICYLATE 0.760 kg

Case No.:41/5/82-

ALC4/2014 ParけName:ALMELO PVT LTD NIleet No/Date:12/82¨ ALC4/2014 10.12.2014 Lic.No/Date:0910060207 1Defer :01/82/050/00358/AM15/1:09/24/040/00096/AM15/23.05。2014 Date:12.01.2015 Pharmaceuticals. CasevΨ882 ヒ3ぜlT19L翌 ffimt"r,D"ff"""d rl 198 IALC4/2014 HQ File :01/82/050/00680/AM15/ PHARMA LIMITED 1常 "盤 Υ and Re-indexed Date:12.01.2015 Status:Deffered Date:12.01.2015 Lic.No/Date:0910060220 1Defer :09/24/040/00094/AM15/126.05.2014 Decision : It was decided to defer the case for 12.01 .20 I 5 for comments of Department of Pharmaceuticals Par″ Name:INDOCO REMEDIES LIMITED Lic.No/Date:0310782942 1Defer :01/82/050/00778/ANI11 5/1:03/94/040/00133/Aゝ/115/126.05.2014 Status:Deffered

Case No.:114/8/82-

ALC4/2014 ALC4/2014 10.12.2014 Decision : It was decided to defer the case for 12.0 I .201 5 for comments of Department of Pharmaceuticals

Case No.:119/8/82‐

ALC4/2014 ParサName:KUSUMA PHARMA Mcet No/Date:12/82- Status:I)effered ALC4/2014 and Re-indexed 10.12.2014 ALC4/2014

Case No.:29/10/82‐

Status:Deffered and Re-indexed 10.12.2014 luq rite lru-n nte No/Date:12/82¨ Re-indexed Re-indexed 鵬星児知ρO割 ^Ⅲ 夕陽念刷iνOm5/AMW際

卜01/82/050/00943/AM15/卜0924/040/00HO/AM15/レ7.05.2014 Date:12.01.2015 器3月5υ∞%5ハⅢy膿ち臆 γ∞∞9ハⅢyl用 器 α知000420日 鳶12劇2m5 Decision : It was decided to defer the case for 12.0 1 .20 I 5 for comments of Department of Pharmaceuticals. ⅣIcet No/Date:12/82- tus:Deffered IName:SYMBIOTEC IALC4/2014 nd Re-indexed PHARMALAB LTD., I.TO.TZ2OTq :It was decided to defer the case for 12.01.2015 for comments ofDepartment of S Meet No/Date:12/82- ALC4/2014 10.12.2014 tatus:Deffered Re-indexed Lic.No/Date:0310783328 :0 t I 82 I 050 I 007 7 9 I AM I s I l:$ I 9 a / 040/00 I s I /AM I s/ lzg.o s .zo A 12.01.2015 Ｆ 鷹 障 ―

Case No.:71/10/82‐

ALC4/2014

Case No.:115/8/82-

ALC4/2014 Paty Name:INDOCO RENIIEDIES LIMITED Pharmaceuticals PaゥName:LAKE CHEMICALS PRIVATE LINIIITED HQ File Lた。No/Dtte:07101045651Detr :01/82/050/00547/AM15/:07/24/040/00003/AM15/128.05.2014 Date:12.01.2015 icals. ParサName:MYLAN IMeet No/Date:12/82- Status:Deffered and Re-indexed LABORATORIES LIⅣlITED ALC4/2014 10.12.2014 Pharmaceuticals PartyName:MYLAN lMeetNo/Date:12/82- 10.12.2014 RLA File Lic.No/Date:09100602581Defer :01/82/050/00702/AM15/:09/24/040/00108/AM15/128.05.2014 Date:12.01.2015 S Pa●y Name:PVS LABORATORIES LTD Mcet No/Datei1 2/82¨ ALC4/2014 10.12.2014

Case No.:145/6/82‐

ALC4/2014 ALC4/2014 10.12.2014

Case No.:34/8/82-

ALC4/2014

Case No.:38/8/82‐

ALC4/2014 Status:Deffered

Case No.:51/8/82‐

Status:Deffered Re-indexed Re-lndexed File No/Date:12/82¨ No/Date:0910060257 103/AⅣ115/ 4

Case No。:101/8/82¨ ALC4/2014 ision : It was decided to defer the case for 12.01 .2015 for comments of Department of Pa●y Name:ENCUBE ETⅢCALS PVT LTD Mcet No/Date:12/82‐ ALC4/2014 10.12.2014 Status:Deffered and Re-indexed 2081器 晶泥5υ00765晨Mlyl鷺 念刷:α00154晨Mly芳 ∬究TC03Ю 783435B章 120.2m5 Patty Name:HINDUSTAN POLYAMIDES&FIBRES LIMITED RLA File :03/94/040/00132/AM15/ Decision : ln the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/9Ol2Ott-Ch. ll dated 31.L0.20L2, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Quantity S,No. Import items Quantity Allowed HAMBER(7-Acetyl― 1,2,3,4,5,6,7,8‐ Octahydro l,1,6,7- TetramethyI Naphthaline) l kg l NIIETHYL ETI‐WL KETONE(Mer) 0.600 kg 2 MYRCENE 1.00 kg Lic.NoノDate:0310783592 1Defer :01/82/050/00764/AR415/1:03/94/040/00129/ANI11 5/129.05.2014 Date:12.01.2015 Pharmaceuticals No.:37/8/82‐ ALC4/2014 P比測田ⅥACHEM PRIVATE LIMITED 10.12.2014 HQ File Defer Date:12.01.2015 :O1/82/050/00701/AM15/:09/24/040/00113/AM15/129.05.2014 comments of Department of Meet No/Date:12/82- ALC4/2014 10.12.2014 Decision : It was decided to defer the case for 12.01.2015 for Pharmaceuticals.

Case No.:114/6/82¨

ALC4/2014 :01/82/050/00516/AM15/ Lic.No/Date:0310783464 29.05.2014

Case No.:100/8/82-

Party Name:IPCA Mcet No/Date:12/82‐ 10。12.2014 1器3月50Ю071yAMlylЪ危刷 iυ00022/AMly 12.01.2015 4 Re-indexed Name:MSN No/Date:12/82- Re-indexed File 53

Case No.:25/8/82‐

ALC4/2014

Case No.:44/8/82-

ALC4/2014 Pa●y Name:VIV1lИ ED LABS LIMITED RLA File :09/24/040/00117/AM15/ Patty Name:PERKIN LABORATORIES ⅣIcet No/Date:12/82- ALC4/2014 10.12.2014 NIleet No/Date:12/82- ALC4/2014 10.12.2014 ision : It was decided to defer the case for 12.01.2015 for comments of Department of Pharmaceuticals Ⅳleet No/Date:12/82- ALC4/2014 Lic.No/Date:0910060340 1Defer :01/82/050/00944/AM15/1:09/24/040/00097/AM15/103.06.2014 Date:12.01.2015 ticals IName:GLENMARK IALC4/2014 GENERICS LIMITED l10.12.2014 Lic.No/Date:0310784177 Defer :0 t l82l 050 I 007s I /AM I 5 / i:03 194 I 040/00 I 56/AM I 5 I 03.06.20 1 4 Date:12.01.2015 Pharmaceuticals ｄ ｅ Ｓ ｔ ａ ｔ ｕ ｓ ‥ ¨ Lic.No/Date:0910060289 1Defer Date: 29.05.2014 Decision : ln the light of written comments received from Department of Chemicals and Petrochenl:cals vide their U.O No. 14010/64/2013-Ch. ‖dated ll.11.2014′ it was decided to ratify norms under Para 4.7 of HBP vl as per details g市 en below or as applied by the nrm′ whicheveris less: Export product 呻 ¨ S.No. Import items Quantity AHowed SODIUM ASCORBYL PHOSPHATE OR C‐ VITE l kg 1 L‐ASCORBATE 2‐ PHOSPHATE 35% OR CALCIUM ASCORBYL PHOSPHATE 1.94 kg う ん METHANOL 3.00

Case No.:30/10/82‐

Party Name:EYTAN LABS LIⅣIITED Status:Deffered 10.12.2014

Case No.:87/8/82‐

ALC4/2014 Status:Deffered

Case No.:113/6/82‐

Name:HINDUSTAN Mcet No/Date:12/82‐ 西 File File 0060298 Re-indexed 12.01.2015 Re-indexed Re-indexed No/]Date:12/82‐

HQ File :01/82/050/00515/AⅣl15/ 「臆電器 「 RLA File :03/94/040/00162/AM15/ 10.12.2014 Mcet No/Date:12/82‐ ALC4/2014 10.12.2014 10.12.2014 Defer Date:12.01.2015 ParサName:SUN PHARNIIACEUTICAL INDUSTRIES LTD., Decision : It was decided to defer the case for I 2.0 I .201 5 for comments of Department of Pharmaceuticals Status:Deffered Meet No/Date:12/82- ALC4/2014 10.12.2014 HQ File Lic.No/Date:0910060380 :01/82/050/00713/A卜115/1:09/24/040/00121/AR415/ 105.06.2014 Date:12.01.2015 Pharmaceuticals :]Deffered ALC4/2014 nd Re-indexed 10.12.2014 Lic.No/Date:0310784160 03.06.2014 Decision : in the light of written comments received frorn Department of Chemicals and Petrochemica:s vide their u.O No.14010/90/2011-Ch.‖ dated 31.10.2012′ it was decided to ratify norms under Para 4.7 of HBP vl as per detalls g市 en below or as applied by the nrm′ whichever is less: Export product Export Quantity S.No. Import items Quantity Allowed HAMBER(7-Acetyl‐ 1,2,3,4,5,6,7,8-Octahydro l,1,6,7‐ Tetramethyl Naphthaline) l kg l METHYL ETHYL KETONE(Mer) 0。600 kg 2 MYRCENE 1.00 kg

Case No.:68/6/82‐

ALC4/2014 Status:Deffered Paty Name:HETERO LABS LIMITED

Case No.:47/8/82¨

: It was decided to defer the case for 12.0 I .201 5 for comments of Department of

Case No.:49/8/82‐

ALC4/2014 Party Name:HETERO LABS LIMITED Status:Deffered Case No。:15/8/82‐ ParサName:ALMELO PVT LTD 55 剛 /NIRMAL T<UMAR Ｆ 巨 No/Date:12/82‐ Re‐indexed Re-indexed Re-indexed 14 Ｆ Ｌ Ｆ Ｉ No/Date:12/82‐

Pharmaceuticals

Case No.:48/8/82‐

ALC4/2014 ParサName:ALMELO PVT LTD Decision : It was decided to defer the case for I 2.0 I .20 I 5 for comments of Department of Pharmaceuticals ALC4/2014 10.12.2014 ⅣIect No/Date:12/82- ALC4/2014 10.12.2014 Re-indexed LicoNo/Date:0910060402 :01/82/050/00712/AM15/1:09/24/040/00118/ANI11 5/109.06.2014 12.01.2015 Re-indexed Lic.No/Date:0910060413 :01 I 821 050 / 007 I 8/AM I 5 I l:09 124 I 040 / 00 I 23 I AMI 5 I ll 0.06.20 1 4 12.01.2015 PaゥName:MYLAN IMcetNo/Date:12/82- tatus:Deffered 箆31器 3月5υ∞η4晨Ⅲy膨 臆 γ剛3mmyl撚 鼎 α "Ю %m18荒 12劇2m5

Case No.:40/8/82¨

ALC4/2014 LABORATORIES LINIIITED Pa●y Name:INDOCO RENIIEDIES LINIIITED ALC4/2014 10.12.2014 Re-indexed NIleet No/Date:12/82‐ Status:Deffered ALC4/2014 10.12.2014 and Re-indexed 箆4器 島児5υ∞ηは剛y閉蔦 /剛m.叩yl蹴鼎 α “ Ю賀""B鳶12劇2m5 ision : It was decided to defer the case for 12.01.2015 for comments of Department of S ParけName:BAYER IMcetNo/Date:12/82- Status:Deffered IALC4/2014 and Re-indexed 10.12.2014 : It was decided to defer the case for 12.01 .20 1 5 for comments of Department of S

Case No.:105/8/82-

ALC4/2014 S IName:AUROBINDO PHARVIA LINIIITED ic.No/Date:0910060441

Case No.:54/8/82‐

ALC4/2014 PびけName:GLAND PHARNIA LIⅣIITED

Case No.:106/8/82-

ALC4/2014

Case No.:58/8/82¨

ALC4/2014 ALC4/2014 10.12.2014 Status:Deffered lRra rit" 56 -lLi: File File 1/82/050/00769/AM15/ 5/112.06.2014 12.01.2015 File

l:0 t t 821 0 s0 I oo7 22/ AMt s t l:09 124 I 040 I oo 1 37 I AM 1 s/ | B .06.20 1 4 lDate: 12.01 .201 5 Party Name:BIO‐ TECH IMcetNo/Date:12/82- Status:Deffered 10PHTHALMICS PVT. IALC4/2014 10.12.2014 2271111)I〕 ):50/00974/AM15/11]:チ〕 :λi Ｆ Ｌ Ｆ Ｉ Lic.No/Date:0810132332 1Defer 卜01/82/050/00974/AM15/1:08/24/040/00116/AM15/113.06.2014 ticals [騨棚 &昴ド鮒~ Party Name:VIJAYASRI Mect No/Date:12/82- ORGANICS LTD ALC4/2014 10。12.2014 Defer Date: :01/82/050/00719/AM15/ 1:09/24/040/00127/AM15/ : Committee considered the case as per agenda and in light of written comments from Department of Pharmaceuticals and in consultation with technical authority in meeting, decided to rati″ n0111lS under para 4.7 of HBP as per details below or as ied by firm whichever is lower:- concerned may take further necessary action as per above decision of NC. ヽ4eet No/Date:12/82- ALC4/2014 10.12.2014 ffi< qrqrglNIRMAL KUMAR gq qerrq-(qrm' r+qql qrqr{ Dv. Oirector General of Foreign Trade frr<cl rryIqr{ :rsrr+<vrrgq Direclorate General of Foreign Trade qIFFq f${FlDepartment of commerce sdr.r areq. Eg GrGfr Udyog Bhawan, N€w Delhi

Case No.:60/10/82-

ALC4/2014

Case No.:149/6/82…

ALC4/2014 Status:Deffered

Case No.:55/8/82¨

ALC4/2014 Lic.No/Date:09100604 13.06.2014 Export product 4-FLUORO‐ a‐ 2‐METHYL-1- OXOPROPYL)‐g-OXO― N―B‐ DIPHENYL BENZENE BUTANEAMIDE(DIKETONE ‐INTERNIIEDIATE FOR ATORVASTATIN)/DKT‐ 3 FLUOROBENZENE METHYLISO BUTYRYL ACETATE(MIBA POTASSIUM CARBONATE

Case No.:57/8/82¨

Party Name:VIJAYASRI ORGANICS LTD Re-indexed Re-lndexed TD., Ｆ ト ー ト ト ト 1229 眸 叫 SIoNo. Import items Qtv. Allowed Koko l kg 0.58 2 0.80 ０ フ 1.00

Lic.No/Date:09100604 :01/82/050/00721/AM15/ :09/24/040/00128/AM15/ 13.06.2014 ision : Committee considered the case as per agenda and in light of written comments ived from Department of Pharmaceuticals and in consultation with technical authority ,ent in meeting, decided to ratiff norns under para 4.7 of HBP as per details below or as lied by firm whichever is lower:- Export product Exp.Qty. SI.No. lmport items Qty. A:lowed Kg/kg 4-FLUORO― a-2-METHYL-1- OXOPROPYL)― g-OXO― N― B― DIPHENYL BENZENE BUTANEAMIDE(DIKETONE― !NttERMED!ATE FOR ATORVASTATIN)/DKT-3 l kg 1 FLUOROBENZENE 0.58 2 M EttHYL ISO BUTγRYL ACETAttE (M IBA} 0.80 3 POttASSIUM CARBONAttE 1.00 concerned may take further necessary action as per above decision of NC.

Case No.:154/6/82‐

ALC4/2014 ParサName:MOREPEN LABORATORIES LTD., :01/82/050/00556/ANI11 5/1:05/24/040/00132/ANI11 5/116.06.2014 NIleet No/Date:12/82- ALC4/2014 10.12.2014 Lic.No/Date:0510388703 Meet No/Date:12/82- ALC4/2014 10.12.2014 tatus:1りellerea nd Re-lndexed 12.01.2015 Pharmaceuticals tatus:Deffered Re-lndexed 2321HQ File Lお.No/Dttα 03107855011Deたr :01/82/050/00741/Aヽ415/1:03/94/040/00196/AM15/117.06.2014 Date:12.01.2015 lDecision : It was decided to defer the case for 1 2.01 .20 I 5 for comments of Department of C&PC

Case No.:30/8ノ82-

PaゥName:INDIAN IMcetNo/Dttα 12/82- Status:Deffered ALC4/2014 INIIMUNOLOGICALS iALC4/2014 and Re-indexed 10.12.2014 lDecision : It was decided to defer the case for 12.01.2015 for comments of Department of DBT.

Case No.:77/8/82¨

ALC4/2014

Pa●y Name:PORUS LABORATORIES PVT LTD. Meet No/Date:12/82- ALC4/2014 Status:Deffered

Case No.:72/8/82…

10.12.2014 ▼ File File 1/82/050/00694/AM15/ 15/ 117.06.2014 58

sion : In the light of written comments received from Department of Pharmaceuticals vide OM No. 35011124312014-PI(Norms) dated October 2014, it was decided to cal from the irm fol lowing information : (a) Certificate of Analysis from Foreign supplier for the relevant consignment of imported crude product. (b) COA of Export product as per shipping Bill/Purchase Order. case is deferred for 12.01.2015 RLA File :34/24/040/00070/ANI11 5/ ξ υ う ０ う ∠ 1騨買柵AL「 NIleet No/1Date:12/82‐ ALC4/2014 10.12.2014 HQ File RLA File Lic.No/Date:0910060467 1Defer :0 1 I 82/ 0 5 0 I 006 84/AM I 5 / i:09 124 I 040 I 00 139 I AMI 5 I 17.06.2014 Date:12.01.2015 ヽ4cet No/Date:12/82¨ ALC4/2014 10.12.2014 HQ File Lic.No/Date:0510388783 1Defer :0 t I 82 I 05 0 I 00 s 62t AM t 5 I l:0 5 t23 I 040/0005 3/AM I s/ I I 8.06.20 I 4 Date:12.01.2015 NIleet No/Date:12/82¨ ALC4/2014 10.12.2014 Deffered Re-indexed 響 惑曜 : Dyttr融 | 聰 需要塾:逗どT ] : UttgrJ 製鷲れ蘇発雨 ParサName:SHIVA PHARNIIACHEM LTD,

Case No.:235/6/82‐

ALC4/2014 ALC4/2014 10.12.2014 :01/82/050/00637/Aヽ415/ Lic.No/Date:3410040261 17.06.2014 )ecision : !n the ‖ght of written comments received from Department of Chemicals and 》etrochemicals v:de their u.O No.14010/164/2011-Ch.‖ dated 12.12.2014′ it was decided to atify norms under Para 4.7 of HBP vl as per detalL g市en below or as applied by the nrm′ vhichever is less: Export product Export Quantity S.No. Import items Quantity Allowed NEO DECANOYL CHLORIDE Min 99% l kg 1 NEODECANOIC ACID Min。99% 0.970 kg

Case No.:20/8/82-

ALC4/2014 Status:Deffered : It was decided to defer the case for I 2.0 I .20 I 5 for comments of Department of

Case No.:160/6/82-

Party Name:ALCHEM INTERNATIONAL

Case No.:19ノ8/82-

Party Name:HETERO ALC4/2014 LABS LIMITED 59 Udy09 BhaWan, Ｆ Ｌ ド ー File 1/82/050/00736/ANI11 5/ 105/AM15/117.06.2014 No/Date:12/82‐ F‖ e Re-indexed Re-indexed

1:1)3):50/00683/AM15/111'チらう liO/00153/AM15/1:::lさら 1lTe:09100604患`|:;『:12.01.2015 : It was decided to defer the case for 12.01.201 5 for comments of Department of icals

Case No.:73/8/82-

Paゥ Mcet No/Date:12/82- Status:Deffered ALC4/2014 Name:METROCHEM IALC4/2014 and Re-indexed APIPVT.LTD. 10.12.2014 ision : It was decided to defer the case for 12.01.2015 for comments of Department of Mcet No/Date:12/82- latus: pproved IALC4/2014 10.12.2014 HQ File :01/82/050/00626/AM15/

Case No.:68/10/82¨

PartyName:LEBEN jMeetNo/Date:12182- Status:Deffered ALC4/2014 ALC4/2014 and Re-indexed 10.12.2014 S Meet No/Date:12/82- ALC4/2014 10.12.2014 Status:Deffered Lic.No/Date:5610004310 :01/82/050/00632/AM15/:56/24/040/00010/AM15/23.06.2014 12.01.2015 LABORATORIES PVT.LTD., Decision : It was decided to defer the case for 12.01.201 5 for comments of Department of Pharmaceuticals 舗 Case No。:224/6/82‐ Party Name:SHIVA PHARMACI・IEM LTD, :34/24/040/00069/AM15/ Decision : ln the ‖ght of written comments received from Department of chemicals and Petrochemicals vide the:ru.O No.14010/164/2011-Ch.‖ dated 12.12.2014′ it was decided to rat:fv normS under Para 4.7 of HBP vl as per details g市 en below or as applied by the nrm′ whichever is less: Export product Export Quantity S.No. Import items Quantity Allowed 2-Ethyl HexanoyI Chloride (99%minium) l kg 1 2-Ethyl Hexanoic Acid 0.952 kg

Case No.:230/6/82‐

ALC4/2014 60 File File 1/82/050/00737/ANI11 5/ 151/AM15/119.06.2014 ′ic.No/Dat 9.06.2014 Re-indexed File 1/82/050/00982/AM15/

Case No.:111/8/82-

Status:Deffered and Re-indexed Decision : It was decided to defer the case for I 2.0 I .20 I 5 for comments of Department of Pharmaceuticals [辮響Q諄灘~ ParサName:LUPIN LIⅣIITED :Deffered Re-indexed Status:Deffered and Re-indexed 24椰 33月5剛η νAⅢy脇 酬:OЮ 鯰仰AMy猪 調器 α “ Ю ・ ""B誰 12劇2m5 す 鵬 星児5υ∞ "2晨 Ⅲy膨 鵬 γ∞ “ νAⅢyl淵 鼎 α0410158822B寛 12劇2∝5 Pharmaceuticals : It was decided to defer the case for I 2.0 I .201 5 for comments of Department of Pharmaceuticals HQ File :01/82/050/00980/Aヽ/115/ Lic.No/Date:0310785910 1Defer :03/95/040/00224/AM15/ 124.06.2014 Decision : ln the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/64/20L3-Ch. ll dated t2.t2.20L4, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product 呻 ¨ S,No. Import items Quantity Allowed STERO NFM(N‐FORⅣ〔YL MORPHOLINE) l kg 1 MORPHOLINE 0.890 kg ParサName:ALEMBIC PHARMACEUTICALS LTD 肩臨辮習而雨 B鳶12劇.卸b り

Case No.:107/8/82-

W鮒~

Case No.:170/6/82‐

ALC4/2014 PaゥName:SOFTGEL IMedNo/Dtte:12/82- Status:Deffered and Re-indexed

Case No.:231/6/82¨

ALC4/2014 ALC4/2014 10.12.2014 61 78/AM15/ File 10.12.2014 12.01.2015 TH CARE PVT. TD。, No.:66/10/82- Name:STERLING No/Date:12/82¨ 10.12.2014 No/Date:12/82- File lRLA File

Decision : It was decided to defer the case for I 2.0 I .20 1 5 for comments of Department of Pharmaceuticals 器星児50Ю0489ハMil陽 が liυ00И9/AMi;♭::∬3冊 α0910060537B鳶 12.0■2015

Case No.:87/6/82‐

ALC4/2014 ParサName:DⅣIS LABORATORIES LTD., Pa●y Name:DIVIS LABORATORIES LTD., Mcet No/Date:12/82- ALC4/2014 10.12.2014 :Deffered nd Re-indexed 12.01.2015 us:Lrefiered Re-indexed 10.12.2014 Decision : It was decided to defer the case for 12.01 .20 I 5 for comments of Department of Pharmaceuticals R4eet No/Date:12/82- ALC4/2014 10.12.2014 HQ File Lた。No/Dtte:09100605361Detr :01/82/050/00491/AM15/1:09/24/040/00150/AM15/125.06.2014 LABS PRIVATE LINIIITED ALC4/2014 10.12.2014 1/ 25 1 NIteet No/Date:12/82¨ Pharmaceuticals 133泥5剛θσAM y陽角帰liυ∞ИνAMy猪∬鼎 α酬∞ωttB府 12m2鋭5 Decision : It was decided to defer the case for 12.01 .20 I 5 for comments of Department of Pharmaceuticals Parly Name:SURVIVAL Mcet No/Date:12/82- TECHNOLOGIES ALC4/2014 PVT.LTD. 10.12.2014 HQ File :01/82/050/00772/ANI11 5 :03/95/040/00214/ANI11 5 賓

Case No.:89/6/82‐

ALC4/2014

Case No.:32/8/82‐

Case No.:108/8/82‐

IALC4/2014 Lic.No/Date:031078602 Decision : !n the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No.14010/62/2010‐ Ch.‖ dated 08.01.2014′ it was decided to ratify norms under Para 4.7 of HBP vl as per details g市 en below or as applied by the nrm′ whichever is less: Export product Export Quantity S.No. Import items Quantity Allowed N-Methoxy-N-Methyl Acetamide l kg 1 N;o- Dimethylhydroxylamine Hydrochloride 1.431kg 匹ICaseNo.:52/8/82‐ ParりName:LAKE Re-indexed File

CHENIIICALS PRIVATE IALC4/2014 LIMITED 10.12.2014 HQ File RLA File Lic.No/Date:0710105418 1Defer :01/82/050/00716/AN115/ :07/24/040/00096/AM15/26.06.2014 Date:12.01.2015 ALC4/2014 10.12.2014 HQ File Lic.No/Date:0310786143 1Defer :01/82/050/00744/Aゝ/115/1:03/95/040/00250/AM15/ 127.06.2014 Date:12.01.2015 lDecision: Itwasdecidedtodeferthecasefor 12.01.2015 forcommentsof Departmentof C&PC 一 LicoNo/Date:0310786H41Defer Status:Deffered Date:12.01.2015 HQ File :01/82/050/00977/Aゝだ15/ :03/95/040/00254/AM15/127.06.2014 : It was decided to defer the case for I 2.0 I .20 I 5 for comments of Department of

Case No.:80/8/82¨

ALC4/2014 Status:Deffered

Case No.:63/10/82‐

ALC4/2014 ALC4/2014 10.12.2014 Decision : It was decided to defer the case for 12.0 I .20 I 5 for comments of Department of Pharmaceuticals Casc No.:219/6/82- ALC4/2014 Status:Deffered and Re-indexed 躙 児5γ∞のぬMダ 鵬 監 OЮ囲 ハ剛yl淵 器 α “ Ю ・ 6118B鳶 12■2m5 Decision : It was decided to defer the case for 12.0 I .201 5 for comments of Department of Pharmaceuticals ド鮒~ HQ File lnre rite llic.NoノDate:0810132520 1Defer :01/82/050/00601/AM15/ :08/24/040/00569/ANl14/30.06。2014 Date:12.01.2015 Status:Deffered and Re-indexed : It was decided to defer the case for 12.0 I .20 I 5 for comments of Department of

Case No.:199/6/82‐

ALC4/2014 Status:Deffered Decision : It was decided to call from the firm CA certificate certiffing past production and umption data for the last 3 years. The case is deferred for 12.01 .2015. IName:H.J.AROCHEM ALC4/2014 10.12.2014 icals. 63 Re‐lndexed Name:PREGNA Mcet No/Date:12/82- TIONAL Re-indexed No/Date:12/82‐ Re-indexed Name:UNICHEM No/]Date:12/82- TORIES 10.12.2014 Re-indexed .LTD., No.:202/6/82- Name:FORACE No/Date:12/82- YMERS(P)LTD.

Case No.:62/8/82‐

Party Name:ADCOCK INGRAM LTD, :01/82/050/00726/AM15/卜07/24/040/001H/AM15/102.07.2014 HQ File HQ Filc :01/82/050/00620/Aヽ/115/ Pa“y Name:RA CHEM PHARMA LINIIITED Lic.No/Date:0710105491 1Defer Meet No/Date:12/82- ALC4/2014 10.12.2014 :12.01.2015 Status:Deffered and Re-indexed Petrochemicals.

Case No.:29/8/82‐

ALC4/2014 Party Name:DIVIS Mect No/Date:12/82‐ PHARMACEUTICALS IALC4/2014 PRIVATE LIⅣIITED i10.12.2014 : It was decided to defer the case for I 2.0 I .20 1 5 for comments of Department of S Lic.No/Date:03107864181Defer :0 I I 821 050 I 007 47 I AMI 5 I l:03 19 5 I 040/00 I 09/AM I 5 I 104.07 .20 | 4 Date:12.01.2015 Decision : It was decided to defer the case for I 2.0 I .20 1 5 for comments of Department of ision : [t was decided to defer the case for 12.01.2015 for comments of Department of

Case No.:64/10/82-

Party Name:SATYAJIT lMeet No/D ate:12182- Status:Deffered ALC4/2014 ALC4/2014 10.12.2014 and Re-indexed PVT.LTD., : It was decided to defer the case for I 2.0 I .20 1 5 for comments of Department of Pharmaceuticals Mcet No/Date:12/82- ALC4/2014 10。12.2014 Status:Deffered RLA Filo :03/95/040/00246/AM15/ :12.01.2015 -3■ :、′NlRYttL KUMttR 丸1赫 1癖器d評幅。 D慨 寧 r郷 gitt de arFrq frqrryoepartment of comm€rce sd.r rrqq, q-€.ffi t l.l,^^ PL ^ ' "- ' - Status:Deffered ALC4/2014 10.12.2014

Case No.:83/8/82‐

ALC4/2014 Meet No/Date:12/82- Status:Deffered Name:MANGALAM ORGANICS LIMITED

Case No.:218/6/82-

Party Name:UNICHEM LABORATORIES and Re-indexed Lic.No/Datc:0310786466 107.07.2014 Filc 1/82/050/00682/Aヽ415/ File 81/AM15/04.07.2014 Y ALA 76/AM15/104.07.2014 AM15/107.07.2014 Re-lndexed Re-lndexed 12.01.2015 Re‐lndexed 12.01.2015 12.01.2015 No.:18/8/82-

Pharmaceuticals

Case No.:28ノ10/82‐

ALC4/2014 P".ty N"r""'CLOC HEI,I Status:Deffered INDUSTRIES LINIIITED and Re-indexed : It was decided to defer the case for 12.0L20I5 for comments of Department of Pharmaceuticals PaゥName:NAPROD IMeetNo/Dtte:12/82- Status:Deffered LIFE SCIENCES PVT. IALC4/2014 and Re-indexed 10.12.2014 Decision: Itwasdecidedtodeferthecasefor 12.01.2015 forcommentsof Departmentof Pharmaceuticals xTa)路視γ 10/82‐ [1:至露露吾霞ξ ,翼 下 G 111)i3:):50/00976/AM15/111;::テli;:::;1,111::テ Mcet No/Date:12/82‐ IStatus:Deffered ALC4/2014 and Re-indexed 10.12.2014 ALC4/2014 10.12.2014 Lic.No/Date:03 10786523 1Defer 08.07.2014 Date:12.01.2015 C&PC. PaゥNamcMYLAN IMeetNo/Dtte:12/82¨ LABORATORIES LIMITED 267 133児5α∞ “ yAM夕 陽ち臆 OЮO134/AMyl脚 器 α "Ю %%28鳶 12劇2m5 Decision : [t was decided to defer the case for 12.01 .2015 for comments of Department of Pharmaceuticals Name:AUROBINDO IALC4/2014 PHARMA LIMITED 10.12.2014 1lf)13:):50/00946/AM15/ Lic.No/Date:0910060655 Defer :09/24/040/00182/AM15/111.07.2014 Date:12.01.2015 ParりName:MOuPEN LABORATORIES LTD., NIleet No/Date:12/82- ALC4/2014 10.12.2014 ALC4/2014 10.12.2014

Case No.:84/8/82‐

Case No.:21/8/82‐

ALC4/2014 Status:Deffered

Case No.:32/10/82‐

Status:Deffered and Re-indexed

Case No.:194/6/82‐

Status:Deffered ALC4/2014 lHq rite ¨ iLi".No/oute:05 I 03 89654 lDefer 111)i3:):50/00942/AM15/lli'チら刷 10/00143/AM15/ 戸 Ｌ Ｆ Ｉ No/Date:12/82‐ 12.01.2015 12.01.2015 Re‐lndexed 5/108.07.2014 No/]Date:12/82‐

l:0 t I 821 0s0 /00s 96lAM I s / l:os /2a/ 040 t oo t 47 t AM I s/ I I t .o7 .20 t 4 : [t was decided to defer the case for 12.01.2015 for comments of Department of Is ParサName:SATYA DEEPTHA PHARNIIACEUTICALS LTD Date:12.01.2015

Case No.:14/8/82‐

Meet No/Date:12/82- cision : The Committee considered the case as per agenda and in light of written comments ;eived from Department of Pharmaceuticals vide their OM No. 350lll34ll20l4-Pl(Norms) ted 28.11.2014 and in consultation with technical authority present in meeting, decided to ifu norms under para 4.7 of FIBP as per details below or as applied by firm whichever is ver:- Export product Export Qty. Sl.No. Import items Qty. aHowed kg/kg (2S,3S)1,2-epoxy-3- (butoxycarbonyl) amino-4- phenylbutane[(S,S)-BOC Epoxidel l kg 1 (3 S)-3 -(tert-Butoxycarbonyl) amino- I -chloro-4-phenyl-2 - butanone (Chloroketone) 1.60

Case No.:36/8/82‐

ALC4/2014 :01/82/050/00700/AM15/1:09/24/040/00198/Aヽ 415/114.07.2014 ParりName:RA CHEM PHARNIIA LIMITED Paty Name:PANACEA BIOTEC LTD., Meet No/Date:12/82- ALC4/2014 10。12.2014 Lic.No/Date:0910060661 1Defer HQ File Mcet No/Date:12/82- ALC4/2014 Lic.No/Date:0410159026 18.07.2014 Datei1 2.01.2015 Defer Date:12.01.2015 10.12.2014 RLA File Lic.No/Date:0510389734 1Defer :01/82/050/00602/AM15/ :05/24/040/00168/AM15/116.07.2014 Date:12.01.2015 Biotecnology. HQ Filc :01 Status:Deffered and Re-indexed

Case No.:200/6/82-

Status:Deffered 10.12.2014 :04/24/040/00067/AM15/ … =pttTTt′ MAL KUMAR File Re¨indexed : It was decided to defer the case for 12.0 I .20 1 5 for comments of Department of No.:214/6/82- No/Date:12/82‐ 14 66 Re-lndexed

Pharmaceuticals

Case No.:72/10/82‐

ALC4/2014 Party Name:GLOBAL CALCIUM PRIVATE Status:Deffered and Re-indexed ALC4/2014 10.12.2014 HQ File :01/82/050/00986/AM15/卜07/24/040/00H2/AM15/ : It was decided to defer the case for 12.01 .201 5 for comments of Department of ParサName:DEEPAK NITRITE LIMITED RLA File Lic.No/Date:0710105884 18.07.2014 Defer Date:12.01 .2015 Deffered Re-indexed 品鑽 諄 雪趙 根鐸 葛醒狐繁難:: 歳 臨 ボ隅秘量i鍵 薫酔舗雷累む逗癬:T utatus: Approved P".ty N"T.SHANPAR INDUSTRIES PVT. LTD. HQ File Lic.No/Date:3410040385 1Defer :01/82/050/00734/AⅣl15/ :34/24/040/00097/AⅣl15/ Date:12.01.2015 : It was decided to defer the case for I 2.01 .201 5 for comments of Department of

Case No.:103/8/82-

Mcet No/Date:12/82¨ Status:Deffered ALC4/2014 and Re-indexed 10.12.2014 ticals 薄謎胤r"‐ 障湘:員題冊 紳

Case No.:69/8/82‐

ALC4/2014 ALC4/2014 10.12.2014 Lic.No/Date:3410040383 21.07.2014 Decision : ln the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 1,4010/3612OL2-C. ll dated L2.L2.2OL4, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Quantity S,No. Import items Quantity Allowed 2,3 Xylidine l kg 1 Ortho Xylene 1.21 kg

Case No.:70/8/82‐

Status:Deffered ALC4/2014 10.12.2014 Mect No/Date:12/82- ALC4/2014 67 部鷲黒郡籠 No/Date:12/82- No/Date:12/82‐ Re-indexed Name:IPCA TORIES 4 AM15/22.07.2014 12.01.2015

Ito.tz.zot+

Case No.:71/8/82-

ALC4/2014 : It was decided to defer the case for 12.0 I .20 1 5 for comments of Department of ticals Party Name:ALEMBIC lMeet No/Date:12/82- PHARNllACEUTICALS LTD ALC4/2014 10.12.2014 Paty NameiCADILA HEALTHCARE LTD。 , ALC4/2014 10.12.2014 Status:Deffered and Re-indexed : It was decided to defer the case for 1 2.0 I .20 1 5 for comments of Department of icals Meet No/Date:12/82‐ ALC4/2014 10.12.2014 Decision : ln the ‖ght of wr:tten comments received from Department of Chemicals and Petrochemica:s vide their U.O No.14010/164/2011-Ch.‖ dated 12.12.2014′ it was decided to raJfy norms under Para 4.7 of HBP vl as per detaiL g市en below or as applied by the nrm′ Patty Name:EMCURE IMectNo/Date:12/82¨ Status:Deffered and Re-indexed PHARMACEUTICALS iALC4/2014 10.12.2014 Decision : It was decided to defer the case for I 2.0 I .20 I 5 for comments of Department of 雪署暴返需dが。 ｔ ｔ ｅ Ｃ 　 ａ Ｄ Ｄ Status:Deffered : It was decided to deferthe case for 12.01.2015 for comments of Department of

Case No.:3/6/82¨

ALC4/2014

Case No.:12/10/82‐

Party Name:SHIVA PHARNIIACIIEM LTD, Export Qty. 3,5-Dimethylbenzoyl Chloride (DMBC) Assay: Min99% Mesiyylene / 1,3,5-Trimethyl benzene Assay: Min99%

Case No.:122/8/82‐

鱚 膜ふ纂h V File 1/82/050/00404/AM15/ 1/AM15/22.07.2014 12.01.2015 Re-indexed Filc /82/050/00735/AM15/ 5/123.07.2014 12.01.2015 65/AM15/23.07.2014 12.01.2015 100/AM15/ ′TD. 1器屋児 5υ00786/AMyl鷺允荒γ Ommハmy 110064607 12.01.2015

lPharmaceuticals

Case No.:64/8/82-

ALC4/2014 2831器島児 5υ00728晨Mlyl鷺ち刷 iυOm89/AM15/[::∬究 Tα 0510389956B鳶12m2m5 ParサName:MOREPEN LABORATORIES LTD., Meet No/Date:12/82- ALC4/2014 Status:Deffered and Re-indexed Date:12.01.2015 tus:Deffered Re-indexed 1棚::[l:|」ItSdecidedtodeferthecasefor12.01.2015 for cornlnents ofDepartment of ALC4/2014 10.12.2014 tus:Deffered Re-indexed HQ File Lic.No/Date:0710106215 1Defer :01/82/050/00987/AM15/1:07/21/040/00370/AM15/128.07.2014 Date:12.01.2015 : It was decided to defer the case for 12.01.201 5 for comments of Department of Pharmaceuticals. PHYTO CHEMICALS IALC4/2014 10.12.2014 ision : It was decided to defer the case for 12.01.2015 for comments of Department of Pharmaceuticals ParサName:RECKITT BENCKISER HEALTHCARE INDIA LINIIITED 躙 掲5γ叩ⅣAMyl鶴鵬υ∞η5/AMlyl撚鼎 α “ Ю"mttB鳶12劇2m5 Decision : It was decided to defer the case for I 2.0 I .20 1 5 for comments of Department of Pharmaceuticals F藤薇下落高 =▼百百ESNA I珈朧D 器星児 5γ0100νAMly Lic.No/Date:0910060837 1Defer 11.08.2014 Decision : It was decided to defer the case for I 2.0 1 .20 1 5 for comments of Department of Pharmaceuticals. 諄♯~ 10.12.2014

Case No.:73/10/82‐

Party Name:ADCOCK INGRAM LTD,

Case No.:26/10/82…

Case No.:66/8/82‐

ALC4/2014 Mcet No/Date:12/82- Status:Deffered and Re-indexed

Case No.:87/10/82‐

Status:Deffered ALC4/2014 10.12.2014

Case No.:2/8/82¨

lHq rite lnra rite 69 ILic,No/Date:2210015079 T Namc:INDO No/Date:12/82‐ 4 Re-indexed File 1/82/050/00940/AM15/ 170/AM15/101.08.2014 」 Ｔ Ｄ 一 Ｆ ｉ ‐ ｅ 10.12.2014 Re-indexed No/Date:12/82-

l:0 t / szt 050 t00666/AM I s t l:22 t2a fi40l000s r iArr,fl v lo: "0q20 I + lDate:12.01.2015 Pharmaceuticals HQ File RLA File Lic.No/Date:0910060946 1Defer :011821050100930/AM l s I l:09124/040t00297 /AMl s/ ll L09.z}t4 Date:12.01.2015 S Pa●y Name:HONOUR LAB LINIIITED Meet No/Date:12/82‐ ALC4/2014 10.12.2014 Pharmaceuticals 器3月5α00668/AMly鵬が liα00318/AMly鵬:∬究γα 0910060963B鳶 12劇.2015 Ｆ Ｌ Ｆ Ｉ HQ File RLA File Lic.No/Date:0910060964 1Defer :0 I I 82 I 050 I 00670/AM I 5 / i:09 /24 I 040 I 003 I 4 I A}..{t 5 I t, tZ.0g .ZO t q Date:12.01.2015 Pharmaceuticals Mcet No/Date:12/82‐ Status:Deffered and Re-indexed ALC4/2014 10.12.2014 :諦3児50/00671/AM15/1鷺ち刷 10Ю0317/AMi5/ Lic.No/Date:0910060965 1Defer 12.09.2014 Date:12.01.2015 Pharmaceuticals

Case No.:8/8/82‐

Pa●y Name:HONOUR LAB LIMITED h4eet No/Date:12/82- ,tatus:lrell-ered nd Re-indexed Status:Deffered and Re-indexed ALC4/2014 Pa■y Name:HONOUR LAB LIヽ41TED : It was decided to defer the case for 12.01 .20 I 5 for comments of Department of Mect No/Date:12/82- ALC4/2014 10.12.2014 and Re-indexed

Case No.:16/10/82‐

Party Name:GLAND PHARMA LIMITED ALC4/2014 10.12.2014

Case No.:4/8/82¨

ALC4/2014 Status:Deffered

Case No.:6/8/82‐

ALC4/2014 IALC4/2014 10.12.2014

Case No.:7/8/82…

Party Name:HONOUR LAB LIMITED

Case No.:9/8/82‐

ALC4/2014 Paty Name:HETERO LABS LIIИITED ‐ Re-indexed Re-indexed 12.01.2015 No/Date:12/82- No/Date:12/82- 15/AM15/12.09.2014

:01/82/050/00673/AM15/卜09/24/040/00320/AM15/115.09.2014 Pharmaceuticals RLA File Patty Name:HETERO LABS LINIIITED Lic.No/Date:0910060967 Ⅳreet No/Date:12/82‐ ド鮒~ 12.01.2015 Status:Deffered and Re-indexed Status:Deffered Date:12.01.2015 隔33月5剛御7AMy膨 臆0側ηハⅢζl悧器 α酬∞ “ %98鳶 12劇2鋭5 Decision : It was decided to defer the case for 12.01 .20 I 5 for comments of Department of Pharmaceuticals Ｆ 巨 Ｆ Ｉ

Case No.:125/8/82‐

ALC4/2014 HQ File Lic.No/Date:0910061000 1Defer :011821050/00789/AM I 5 I i:091241040/00345/AM 15/ itg .09 .2014

Case No.:13/8/82-

ALC4/2014 Pa●y Name:HETERO DRUGS LIMITED, and Re-indexed Decision : It was decided to defer the case for I 2.0 I .201 5 for comments of Department of Pharmaceuticals NIteet No/Date:12/82- ALC4/2014 10.12.2014 Lic.No/Date:0310789468 1Defer 19.09,2014 Date:12.01.2015 ision : It was decided to defer the case for 12.01.2015 for comments of Department of PC.

Case No.:126/8/82‐

Party Name:RELIANCE INDUSTRIES LTD.

Case No.:127/8/82‐

ALC4/2014 Pa●y Name:HETERO LABS LITИITED Status:Deffered and Re-indexed 鵬星児5γ∞"ぬ Ⅲy陽ち臆0側39/AMζ l淵鼎 α酬∞aO"B鳶 12劇2m5 ticals

Case No.:128/8/82…

: It was decided to defer the case for 12.01 .2015 for comments of Department of Party Name:HETERO ILABS LIMITED Ⅳleet No/Date:12/82‐ ALC4/2014 lSt"tr*D"ff"*d land Re-indexed 阿慣霊胤″ 988年 71 File File 1/82/050/00790/ANI11 5/ 10。12.2014 Re-indexed Re-indexed 12.01.2015 Ｆ Ｌ Ｆ Ｉ No/Date:12/82¨ 4 Name:HETERO No/Date:12/82- LIMITED 10.12.2014 10.12.2014 鵬 島児5υ00792晨話 :「IЪち臆 υ0034鳳Ⅲζ

| 鵬島児5γ∞明 ^mダ 陽が脱υ∞釧A叩ダ1淵鼎 α酬∞a∞4B寛 12劇2帆5 : It was decided to defer the case for 12.01.201 5 for comments of Department of and Re-indexed HQ File RLA File ic.No/Date:0910061005 1Defer :01/82/050/00794/AM15/:09/24/040/00332/AM15/122.09.2014 Date:12.01.2015 Decision: Itwasdecidedtodeferthecasefor 12.01.2015 forcommentsof Departmentof Pharmaceuticals

Case No.:131/8/82¨

ALC4/2014 Mect No/Date:12/82‐ Status:Deffered IALC4/2014 and Re-indexed 10.12.2014 Decision : It was decided to defer the case for I 2.0 I .20 I 5 for comments of Department of Pharmaceuticals 脚 @Ft"tr-D.ff"."d 知3鵬 島児5υ∞ "ν AM夕 陽ち臆 γ∞ "3晨 My囲 器 α酬∞ “ 30B鳶 12劇2鋭5

Case No.:78/10/82‐

ALC4/2014 ision : It was decided to defer the case for 12.01.201 5 for comments of Department of HQ File Lic.No/Date:0910061131 :0 t I 821 050 / 00993/AM 1 s I i:09 Da I 040/003 9 I /AM | 5 I 122.1 0.20 1 4 Meet No/Date:12/82¨ ALC4/2014 10.12.2014 NIleet No/Date:12/82‐ ALC4/2014 10.12.2014 Status:Deffered and Re-indexed 12.01.2015 Pharmaceuticals

Case No.:80/10/82-

ALC4/2014 Pa●y Name:HETERO LABS LIMITED tatus:Deffered Re‐lndexed 雪器鉗踏Ⅷ ] : lt was decided to defer the case for 12.01 .201 5 for comments of Department of 脚 鱚 : 写鶏燎拙Te Iro.tz.zot+ Case No。:130/8/82- ALC4/2014 Party Name:HETERO LABS LIMITED

Case No.:79/10/82-

Status:Deffered and Re-indexed ALC4/2014 10.12.2014 icals 72 File 12.01.2015 12.01.2015 Name:HONOUR LINIIITED 1/82/050/00795/AM15/ Name:HttTERO No/Datc:12/82- LIMITED

Paty Name:HONOUR LAB LINIIITED

Case No.381/10/82‐

ALC4/2014 Status:Deffered and Re-indexed ALC4/2014 10.12.2014 HQ File Lic.No/Date:091006H33 1Defer :01/82/050/00995/AM15/1:09/24/040/00407/AM15/122_10.2014 Date:12.01.2015 Pharmaceuticals Decision : It was decided to defer the case for I 2.0 I .20 I 5 for comments of Department of C&PC Patty Name:HETERO DRUGS LIMITED Mcet No/Date:12/82- ALC4/2014 10.12.2014 Status:Deffered and Re-indexed : It was decided to defer the case for 12.0 I .201 5 for comments of Department of ticals 10.12.2014 ParけName:SHIVA PHARMACHEM LTD, HQ File Lic.No/Date:3410040644:Defer :01 1821050101 000/AM 1 5l ;:34124/0401001941 AM I 5/ 130. lO.20l4 Date:12.01.2015 Decision : It was decided to defer the case for 12.01 .2015 for comments of Department of Pa●y Name:HETERO LABS LIMITED Nirmal Kumar Dy. Director General of Foreign Trade ⅣIcet No/Date:12/82- Status:Deffered ALC4/2014 and Re-indexed Date:O4.12.2014 Place:New Delhi

Case No.:82/10/82‐

Case No.:85/10/82‐

ALC4/2014

Case No.:86/10/82‐

Status:Deffered ALC4/2014 10.12.2014 73 No/Date:12/82‐ Name:DEEPAK No/Date:12/82¨ Re-indexed LTD 10.12.2014 File 110065004 5/1:31/83/040/00151/AM15/127.10.2014 12.01.2015 No.:84/10/82¨ File lRLA File 1 I 82 I 0s 0 I 00998t AMt s I i :09 t24 I 040 t00400/AM 1 5 I 127 .1 0 .20 1 4 No/1Date:12/82- Re-indexed 1器3泥50Ю0999/AMlyl鷺ち刷 :γ00403ハMlyl芳∬ 3冊α 091006H41B鳶 :120.2015

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