DGFT Minutes

Offlce of Directorate General of Foreign Trade New Delhi‐ 0 Prra 4.7 Decision@RAFT) MEETING NUMBER :17182-ALC4/2014 MEETING DATE : 05.02.2015 But actually held on 17.03.2015 Meeting No. 17182 ol 2014-15, to consider the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2009-14 pertaining to Chemical and Allied products and falling under chapter 29 and 30, was scheduled for o5.o2.2ols but actually held on '17.03.201 5 under the Chairmanship of Shri Jaikant Singh, Addt. DGFT in Room No.1 I , Udyog Bhawan, New Delhi. Following members were present:- Shri Nirmal Kumar, Deputy Director General of Foreign Trade Shri A.K. Agarwal. Dy. lnd. Adviser, Department of C&pC. Ms. Swati Kumari, O/o Dc (MSME) Shri D.N. Mathur. Consultant, Department of Pharmaceutical Shri Mahendra Vikram Singh, Foreign Trade Development Officer The committee went through the minutes of earlier NC -lll meeting No. 16/82 scheduled for 23.01 .20 15 but actually held on 27 .Q2.201 5 and approved the same. The following cases/issues were discussed and the committee took the decision as mentioned against each case.

Case No.:88/13′ 82‐

IALC4/2014 ILA30RATORIES(P)LTD, Party Name:MAITHzu Meet Nυ Date:17/82- ALC4/2014 05022015 「 iat誌:5しffered and Re‐ indexed | lDcFer~~~~ IDate:15042015 IHQ Fnc :01/82/050/01091/AM15/ IRLA F‖ e :09/24/040/00061プAM15/ Lic No/Date10910060058 12052014 Decision:It、vas dccidcd to dcfcrthc casc for 15 04 2015 Pharmaceuticals. for comments of Department of

Case No:67/4/82-ALC4/2014

Pa“y Namc:DIVIS LA30RATORIES LTD, Mcct No/Date:17/82‐ ALC42014 105022015 1濡:11 IHQ File 101/82/050/00315/AM15/ 鵬鬼北 OЮ創65AM W 四面 2 Decision : commiftee considered the case as per agenda and in light of wriften comments received from Department of Pharmaceuticals vide their oM No. 35ol | 1457 Dol4-pl(Norms) dated March 2015 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- I 賠 a

ｎ 　 ｕ ｃ Ｏ ． ０ ０ ， ０ Ｅ ｘ ｐ ｒ Exp. Qty. SI No lmport items Qty alloWed kg/kg Thiol Acid Kg 1 2,2-BIS-(BromomethYl)- 1,3- Propanediol 7462 2 Dimethyl Formamide 870 3 Dibenzyl Toluene 1235 4 Potassium Thio Acetate 2181 Ｅ υ n-Hexane 039 RA may take appropriate action as per the decision of Norms Committee' 3陽 島児50/O125松my M2yAmy l悧 開 ° "Ю ・ θ%隣 15Ю4加5 Meet No Datc:17/82‐ ALC4/2014 05022015 :It was decidcd to dcferthc casc for 15 04 2015 for commcnts of Department of p5022015 1器3児50畑23AMly Lic No/Date:0310787374 is less: concerned may take further necessary action as per above decision of NC' Party Namc:IPCA LABORATORIES LIMITED ParりName:AVA CHEMICALS PVT LTD, l'dITiiro+oroo:ooraursr'pt.ot.zort )n : In the light of €artier decision taken by NC in its l3l82 meeting dated 19 122014, it was to ratiry the n6rms under para 4.7 of HBP vl as per details given below or as applied by the firm, 器 疏 50Ю りHハⅢy l鷺 ら棚 OЮ0377Amy~囲 爾 貯 Ю "0787389B υ ■411′ ハ■●■■υ′ IV´ '´ ….V'01VV´ ～ ● ‐●レ |~~ ~ ~~~ 1 -一

ara 4.7 of HBP vl as per details given below or as applied by the firm, 器 疏 50Ю りHハⅢy l鷺 ら棚 OЮ0377Amy~囲 爾 貯 Ю "0787389B υ ■411′ ハ■●■■υ′ IV´ '´ ….V'01VV´ ～ ● ‐●レ |~~ ~ ~~~ 1 -一 :It was dccided to deferthe case for 15.04 2015 for commcnts ofDepartment of

Case No.:208/13782-

ALC4/2014 No.:210/13/82- Name:ARIHANTANAM No/Date:17/82‐ PVT LTD No/Date:17/82-

ζ HQ Filc RLA Filc Lic No/Date:0310787473 :01/82/050/01212/Aヽ415/ :03/94/040/00379/AM15/ 31072014 15042015 : It was decided to defer the case for 15.04.2015 for comments of Department of 腰霞黙重証~澪霜露麗百 101/82ノ050/01150/AM15/

Case No.:42/13/82‐

ALC4/20:4 :01/82/050/01045/AM15/ 1榊揚 V冊1鰈… :0924/040/00242/AM15/ : It was decided to defer the case for 15.04.201 5 for comments of Department of 一 　 　 　 　 　 ９ l It was decided to defer the case for 15.04.2015 for comments of Department of 「 一 　 　 　 　 　 　 　 　 Ю 日鱚冊郎 S tti∬"琴閻 .2. Detailed calculation ofarriving at the quantity ofAPI applied. i lThe case was deferred for I 5.04.201 5. 15042015 ‖ 冊 3泥50Ю Ю″ A3了 ¬ 脇 鵬 ν00237/AMl夕 1蹴 辮 Ю "∞ ω ・ 3 15042015 FDecision:It was dedded b defer働e case br 15.04 2015 for comlnents of Department of Pharmaceuticals Med No/Date:17/82- 1詰″盤r DirectOrate CehcrJ of Fof09n Trade 剛 螂]T No/Date:17/82‐ Name:BLISS GVS LTD 5 鴨3児50Ю囲 7ム剛夕 ~脂 λ ttυ∞ "6:「戸~ IDecision:It was decided to rcmind the irlll to mmlsh the fo‖ owing tcchnical details

タ つ ι ν 障蹴∽ 0454/AⅢ夕 1蹴辮“Ю ・ 8餌5 glven applied ― 1器疏50/O120ν Am y : ln the light of written comments received from Department of Pharmaceuticals vide OM No 350H/492/2014-Plぃorms)da“d10022015,l was dccttcd to ra■″ the nOrllls

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

嚇 ィ C"." Nor43/lyS2-ALC420t4 iFatty NameSt'f f leX \4iet No/Date: l7182- 'status: ILABOMTORIES LIMITED lALC4t20t4 lApproved los.oz.zo t s I ,O a* |[A Fll" llicNoroare:09100608s2 ]Defer Date: :0tt82to5ot0tM6tAMt5l t,:o9t24tm0t00255tAM15l 113.08.2014 I E*t"tr" t Irrh" l@entof Pharmaceuticals vide their OM lNo. lsol t /6z8120 t 4-PI(Norms) dated 22.01.2015, it was decided to ratift the norms under Para 4.7 ofHBP lvl as per details given below or as applied by the firm, whichever is less: Export Product Export Quantity S No Import Item Q″ Allowcd kノkg 3-Isobuヮl Glutaric Acid[CMH Diacid] l kg 1 lsovelaraldehyde 06068 2 Ethyl Cyanoacetate 07814 3 Diethvl Malonate 09784 may take appropriate action as per the decision of Norms Comminee. :01/82/050/01202/AM15/ Decision : In the light of earlier decision taken by NC in its meeting No. 20182 dated 16.01.2014 and in consultation with technical members, it was decided to ratify norms under Para 4.7 ofHBP vl as per details given below or as applied by the firm, whichever is less: Export Product Export Qty. SI No lmport items Qty a‖owed Brimonidine Eye Drops 5 ml 100 vans 1 Brimonidine Tartrate 1 05 gm may take appropriate action as per the decision of Norms Committee. Partv Name:FDC LTD 1輻 103/94/040700259/AM15/ S No Export Product Quantity Raw materials allowed Quantity proposed 1 SODIUM CROMOGLICATE fl EYE DROPS135 ML VIALS l Vials ISODIUM CROMOGLICAT 0.2753 gm/vial 2 POLYETHYLENE SYNTHETIC RESIN(LDPE GRANULES) Relevant, as per

y Raw materials allowed Quantity proposed 1 SODIUM CROMOGLICATE fl EYE DROPS135 ML VIALS l Vials ISODIUM CROMOGLICAT 0.2753 gm/vial 2 POLYETHYLENE SYNTHETIC RESIN(LDPE GRANULES) Relevant, as per packing policy No.:199/13′ 82- No/Datc:17/82‐ /

Ｃ ノ つ ４ SODIUM ) CROMOGLICATE
・ EYE DROPS 10 ML VIALS l Vials SODIUM 才 CROMOGLICATE 0.204 gnlvial 2 POLYETHYLENE SYNTHETIC RESIN (LDPE GRAN■lLES) Relevant, as per packing policy may take appropriate action as per the decision of Norms Committee.

Case No:55/13/82-

ALC4/2014 IALC4/2014 105022015 b器 3児5∽Ю58/AM Ы 鵬危北 OЮ026リ Lic No/Date:0910060864 AM15/ 120082014 15042015 1躙胤譜謂“ dded b detr■e cascおr“Ю 42m5おr∞nlmems ofD"armem Of 105022015 Re-indexed

Case No:242/13/82‐

ALC4/2014 1造:淵 o17/82‐ :Defer t:ov82lo5o/ot?45/Aul5t l:$t94th0t00442tAMtst lzz.ot.zot+ Lic No/Date:0310788283:Defer 22 08 2014 1Date:15042015 : It was decided to defer the case for 15.04.2015 for comments of Department ol LIMITED

Case No.:245/13/82-

ALC4′2014 REMEDIES LIMITED p5022015 MAfi7dt ir82- lstatusDeffered 'ty'.tCqtZOtq iand Re.indexed los.oz.zor s , 1麟 ¨ 興 器3児5m22/AM剛 ~ 1蹴 辮 Ю3107“ "3騰 15劇2釧5 「 :i]:in:ltWasdecidedtodeferthec¨ ie for 15 04 2015 for commlents ofDepartment of Pa"Name:VERDANT LIFE SCIENCES PVT LTD

Case No.:229/13/82-

ALC4/2014 「 憂雨I馬でROWN Meet No/Datc:17/82‐ Status:Deffered Name:HETERO DRUGS “隔脇蕊罰蕊 Lic No/Date:0910060869 120082014 6 HQ File File 103/94/040/00300/AM15/

B宥`に加 5 :It was dccided to deferthe case for 15 04 2015 for conlrnents ofDepartment or CALS PVT LTD, ALC4'014 Re-indexed 05022015 :15042015 :It、vas decidcd to defcrthe case for 15 04 2015 for conlmcnts ofDepartmcnt of Partv Name:GOLD STAR CHEMICALS PVT LTD Re-indexed 蹴器α“Ю ・“"囲5Ю4劉5 Name:HETERO DRUGS IMeetNo/Date:17/82‐ , IALC4/2014 R€-iDdexed 05022015 15042015 No:46/13/82- Party Name:HETERO LABS Meet No/Date:17/82‐ LIMITED ALC4/2014 R€-indexed 4 05022015 1器耽50/O104りAmy 15042015 Meet No/Datel1 7/82- ALC42014 Re-indexed 05022015 15042015 Meet No/Date:17/82- Lic No/Datc:0310788328 ヽleet No/Date:17/82‐ Lic No Date10910060885 Lic No/Date:0910060886 :09/24/040/00271/AM15/ CROPSCIENCE LIMITED Lic No Date10310788397 6

Case No:228/13/82-

ALC4/2014 1器柵珊 T), | lstatus:D€ffered land Re-indexed HQ File :01/82/050/01231/AM15/ 鵬λ ttυoo45αAMЫ

Case No.:2Sy13/82-

ALC4/2014 103/95/040/00431/AM15/ PなりName:THE DHARAMSIIMCCt No/Date:17/82‐ MORARJI CHEMICAL CO iALC42014 05022015 Re-indexed 15042015 15042015 DeFre"ed Re-indexed 一 　 　 　 　 　 ２ ７ Re-indexed 105022015 [lili::[「 「]「尋三二 「8ここ I15こ1る「こ efer the case for 15.04.2015 for comments ofI)epartment of Deffered Re-indexed 1蹴鼎° "Ю ・8" 障予渭泌 いoNげD“o03Ю 7885И P&0&2014 Ｆ ‐ ‐ ２ ８ ‐ ‐ Re-indexed 15042015 IDecision:It was decided to deferthe case for 15.04.2015f br comments ofDepartment of C&PC Defer Date115 04 2015 15042015 ゝ Party Name:DELTA FINOCHEM PVT LTD ALC42014 05022015

Case No.:257/13/82_

ALC4/20:4 [lili::]「 「]「尋π二 「8ここ ]i3こlЬ ‐ 五efer the case for 15.04.2015 for conlments ofl)epartment of 釧田蕊:蕊蕊百~囮 話 ::1蔦」囲漑戸 10788513 Party Name:SEQUENT SCIENTIFIC LTD

Case No.:254/13/82‐

ALC4/2014 Meet No/Datel1 7/82- No.:224/13/82- Name:DELTA Name:NAVIN No/Date:17/82‐ 鵬 3児5∽″ "/AMЫ ttλ 棚 。/。。 "除 剛夕 1蹴 辮 Ю3107“ "9 No/Date:17/82‐ R€-indexed 5

ハ 脚 唖 り 前 8

Case No.:262/13/82-

Party Name:ANTHEA Meet No Date:17/82- ALC4/2014 AROMATICS PVT LTD, ALC4/2014 Re-indexed 05022015 15042015 Re-iIldexed RLA File :01/82/050/01266/AM15/ :03/94/040/00962/AM14ノ 15042015 Decision : It was decided to defer the case for 15.04.2015 for comments of Department of Partv Name:RA CHEM PHARMA LIMITED Re-indexed HQ File :01/82/050/01057/AM15/ 1脇乳9Ю舵 "ムmy ~[霰 酬蹴OT2総1 腔場° 1782‐~ 15042015 ALC4/2014

Case No:63/13/82-

ALC4/2014 15042015

Case No.:217/13/82-

Party Name:ENCUBE Meet No Date■ 7/82‐ ETHICALS PVT LTD ALC4/2014 Re-indexed 05022015 15042015 Party Name:KRISHNA ANTIOXIDANTS PVT LTD 15042015 Lic No Datc:0310788560

Case No.:263/13/82‐

Party Name:ANTHEA Mcct No/Date:17/82‐ ALC4/2014 AROMATICS PVT LTD, Lic No/Datc:0310788558

Case No.:54/13/82‐

Meet Nσつate:17/82- ALC4/2014 Lic No/1)ate:0910060901 Lic No/Datc:0310788620

Case No.:223/13/82-

Meet No′lDate:17/82‐ Mtr"D"ff"*d ard Re-indexed ALC4/2014 Lic No/Date:0310788647 Re-indexed

Party Name:STERLING AUXILIARIES PVT LTD 面
鱚 茫 囲需引Ю O““7囲蒜 「or 15 04.2015 for conlments ofDepartment of : It was decided to defer the case for I 5.04.201 5 for comments of Department of q No.:259/13/82- Ptt Name:DANOPHARM IMeet No/Date:17/82‐ PRIVATE IALC42014 and Re‐ indexed File lru-a rite llic.No/Dare:03 t 0788693 No:251/13/82- No:253/13/82- NameiSTERLING No.:234/13/82‐ ParりName:KUSUMA IMeet No7Date:17/82‐

ιθ |:i:1:i':ii「 :'115モ F二 F~~~~― ― ― ― 一 ― ― ,Status:Deffered and Re-indexed I 15042015 No.:196/13/82‐ Party Name:KOPRAN Meet No/Date:17/82‐ 4 LIMITED ALC42014 Re-indexed 05022015 15042015 Partv Name:KRISHNA Mect No/Date:17/82- ANT10XIDANTS PVT LTD IALC42014 05022015 15042015 : It was decided to defer the case for 15'04.2015 for comments of Department of Meet No/Date:17/82- ALC4/2014 05022015 HQ F‖ e 15042015 :01/82/050/01029/AM15/ :03/95/040/00493/AM15/

Case No.:27/13/82‐

Patt Namc:STERLING Mect No′ 1)atel1 7/82- Deffered AUXILIARIES PVT LTD Re-indexed ALC4/2014 05022015 15042015 ALC4/2014

Re-indexed 15042015 : It was decided to defer the case for 15.04.20i5 for comments of Department of Patt Name:MANGALAM ORGANICS LIMITED (FORMERLY DUJODWALA

Case No:26′ 13/82-

Party Name:STERLING AUXILIARIES PVT LTD Lic No/1)ate:0310788939 ゆ File Llic.No/Date:0310788943

|| Decision : It was decided to defer the case for 15.04.2015 for comments of Department of C&PC. 1獣ill胤」|ょlTdecidedtodefcrthccasefor15042015forcommentsofDepartmentof uttbもWJ｀… 鵬 3鷺50Ю Ю7ハm夕 陽 鵬 oЮω BAmy l悧 辮 Ю釧∞ω tt B霜 Namc:EYTAN LABS IMeet No/Datel1 7/82‐ Re-indexed 15042015

LABORATORIES LTD, ル ′ ′ ι

Case No.:67/13/82-

ALC4/20:4 Meet Nυ Date:17/82- ALC4/2014 05022015 Mcct No′つatc:17/82‐ ALC4/2014 DcrFcrcd 鵬疏50ЮЮηハm夕 陽ち雅∽ω∝/AMly H悧鼎 α酬∞ω%0陸徹D“α )14 1 "鵬 脇 50Ю Ю72晨Mり 陽ち肥 υ∞30νAMW F総 辮 Ю "0060%21謙15“2m5 ion : Committee considered the case as per agenda and in light of written comments ed from Department of Pharmaceuticals vide their OM No. 3501I/455/2014-PI(Norms) 26.02.2015 and in consultation with technical authority present in meeting, decided to norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Exp Qty SI No lmport items Qty al10Wed kg/kg (Z)‐ 2‐(2,3- DICHLOROPHENYL)‐ 2- LIQUID (GUANIDINOIMINO) ACETONITRILE l Kg AMINO GUANIDINE BI CARBONATE 106 2 ACETONITRILE 202 3 2,3-DICHLORO BENZOYL CYANIDE 123 may take appropriate action as per the decision of Norms Committee.

Case No:69/13′ 82-

ParりNalne:DiVIS LABORATORIES LTD, Mcct No/Date:17/82‐ ALC4/2014 ALC42014 Re-indexed 05022015

Case No.:85/13/82-

Party Name:EMCURE Meet No/Date:17/82- ALC4/2014 PHARMACEUTICALS LTD IALC4/2014 Re-indexed 05022015

Case No.:197/13/82-

Party Name:KOPRAN Meet No/Datc:17/82- ALC4/2014 LIMITED ALC42014 Re-indexed 05022015 : It was decided to defer the case for 15.04.201 5 for comments of Department of 男 鵬 3鷺5∽Ю “ ハm夕 陽艦 oЮ創 "ハ m夕 田 鼎 副 ЮO“ 辟5薫 鳳鳳 19鵬 島児50畑η O/AMl夕 障蹴 ν∞ “ 7/AMW 田 鼎 前劉 ""“ 4田 [胤ふL Name:SRIAM LABS ATE LIMITED Casc No.:72′ 13/82- 60 ALC4/2014 05022015 Re-indexed Name:DiVIS り

ゝ 辟 ′3 :01/82/050/01075/AM15/ :09/24/040/00287/AM15ノ 15042015 姉 :68/13/82- ~~~ IALC4/2014 | Pa●y Name:AUROBINDO Meet No′ つate:17/82‐ PHARMA LIMITED ALC42014 05022015 一 　 　 　 　 　 ６ ２ 15042015 Re-indexed 15042015 Re-indexed Re-indexed 15042015 甲酉~甲囮 「 階席" 1器3月50畑073AMly Ъ ち刷:OЮ0310/AMly Party Name:SHODHANA Meet No/Datel1 7/82- LABORATORIES LTD ALC4/2014 Re-indexed 05022015 15042015 14 Party Name:TITAN Mect No Datc:17/82‐ LA30RATORIES PVT LTD ALC4つ014 Re-indexed 05022015 Lic No/Date:0310789100 12092014 : Reply received and sent to Department of Pharmaceuticals. The case was deferred for 15042015

Case No.:61/13/82-

ALC4/2014 Lic No7Date:0910060952

Case No.:25/13/82-

ALC4/2014 F 一′ヽ日'MAL CMAК No.:65/13/82- Name:MSN

IЧ Lic No/Datc1031 0789099 12092014 Lic No/Date:0310789281 16092014 1 : ln the light of earlier decision taken in meeting no. 13/82 dated L9.r2.2oL4, it was decided to norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is rrr. N"'JS6itvs! IF"ny N"."f IPLA LN'IITED |MEt M/D"t"'. t ?/8I tSt"t,* \Lc4no'o lfr.frirllT rApproved ia Fll. lo t,f" ll-ic.t to,Oate:Ol loz89169 lDefer Date: 0l/82l0s0/01189/AMl5/ l:03/941040/00573/AM l5/ 115.09.2014 I Da Ptt rrn'.."rtit fla" :heir OM No. 35OLLl28g/2OL4-Pl(Norms) dated 20.01.2015, it was decided to ratify norms under )ara 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: ElpertlroCuct: Abamune-L Baby Tablets/Abacavir Sulfate & Lamivudine Tabs for oral susp tAt 7 S No Export Item Import ofAbaca宙r Sulfhate a■owed for l No.Tablets 1 Abamune-L-Baby Tablets (Abacavir 60mg + Lamivudine 30mg) 61.2 mg 2 Abamune-L Junior Tablets (Abacavir 120mg + Lamivudine 60mg) 122.4 mg 3 Abacavir 600mg +Lamivudine 300mg Tablets 612.0 mg 4 Abacavir Sulfhate Tablets 300mg 306 0 mg S No Import ltem Qty. allowed kg/kg. 1 Forrnamido Amino Dichioro Pyrimidine (FADCP) 1042 う ´ Methylene Chloride 525 RA may take appropriate action as per the decision of Norms Committee. Case No■93/13/82‐ ALC4/2014 :01/82′ 050/O1196/AM15/ Export product 恥 叫 Sl No lmport items Qty Allowed kq/kq NamclENALTEC LABS No/Date:17/82‐ LTD Filc

e action as per the decision of Norms Committee. Case No■93/13/82‐ ALC4/2014 :01/82′ 050/O1196/AM15/ Export product 恥 叫 Sl No lmport items Qty Allowed kq/kq NamclENALTEC LABS No/Date:17/82‐ LTD Filc

一′ぢ/ Ｆ ‐ ‐ ‐ ７ ０ ‐ ‐ ‐ ‐ 一 　 　 　 　 　 ７ ‐ Ｆ Ｉ Ｌ ｒ ｌ ｌ ROSUVASTATIN CALCIUM (ヽ10 Route) l kg 1 6-[(lE)‐ 2〔4(4-FLUROPHENYL)‐ 6-(1‐ METHYLETHYL)‐ 2‐lMETHYL (METHYLSULFONYL)AMINOl ‐ 5‐PYRIMIDINYL]ETHENYL]-2,2‐ DIMETHY L‐ 1,3-D10XANE-4‐ACETIC ACID l,卜DIMETHYLETHYL ESTER 1425 RA concerned may take further necessary action as per above decision of NC. | ヽ Name:EYTAN LABS 15/ 16092014 Decision : It was Pharmaceuticals. decided to defer the case lor 15.04.2015 for comments of Department of No:57′ 13/82‐ ~~ParyNttα HELLOPANTS 10391246 DeFer ‐Datc:15042015 l It was decided to defer the case for 15.04.2015 for comments of Department ol

器3児5∽Ю62/AMⅣ 鵬ち鵬 OЮ0276AM百 開 財 03"245B鳶 1.042∝5 ― lι ― Pany Nalne:HELLO PAINTS iMeet No/Date:17/82‐ (P)LTD ALC4/2014 趾 Z脚 宵よ柵つ[Wr 四 |、I二1蘇′ ~田 需稿:]薇面」 ~1需 需Ю獅"石睡IIJ猛: : It was decided to defer the case lor 15.04.2015 for comments of Department of

Case No.:75/13/82‐

FttNamcPHげU卜A~~lMeet No5ate■782- Lic No/Date10510391274 Partv Name:GRASIM Meet No/Date:17/82- INDUSTRIES LTD, ALC4/2014 05022015 Party Name:CONSTECH Mect No/Date:17/82‐ ENTERPRISES PVT LTD ALC42014 05022015 器3児5∽Юη/AMⅣ 瑶 蹴 OЮυ "蔦 lダ ~囲 鼎 “ Я “ 劇∞8 … 枷 Dopartment of Comm●閥 υ鋼染品話誡 :ぃ

Case No.:74/13/82-

Status:Deffered and Re-indexed

4η ALC4/2014 1器盤r 15042015 「 | LABS[覇 『 而 「需蹴 脚 劇y~1蹴鼎α "Ⅲ“%2請 li餌2m5 Meet No77Date:17/82- ALC4/2014 05022015 鵬 3泥 "畑"3ハ m夕 陽 危淵 υO囲8晨剛yl蹴 辮 Ю ・ 創∝Ъ 5B府 に “ 2∝5 : In the light of written comments received from Petrochemical Division of Depa(ment Chcmicals and Petrochemicals vide their()M No 15022/17/2012-PC― II dated 17 03 2015,it decided to call from the firm the following technical details: i) Detailed manufacturing process along with balanced chemical reaction indicating number of ofall the reactions, products and by-products with corresponding molecular Formulae, formulae, molecular weight and process flow diagram. Stage-wise percentage yield with resp€ct ofeach ofthe reactants and products and the relevant enclosing therewith authentic printed technical literature in support ofyield or of items for import. Detail of by-products formed during the process and their recovery in terms ofquantity and ) Details of production of export product under reference and corresponding consumption of raw 騰塾神部鰤誦‖ i憾1胤:器拙f器。 庶ettt撃 The casc was dcfcrrcd for 15 04 2015 Status:Deffered and Re-indexed l ferthecasefbr15.04.2015 fbr comments ofDeparment Of 甲 F~陣 器 鮒 許D朧 鮮 引ル Filc 10391347 Ю1/82/050/01050ハM15/
Ю5/23/040/00278AM 15/ 092014 Actual content of Digoxin in imported digitalis Lanata Leares supported by COA from foreigner supporter Assay of Export Product ＞ 　 　 ぅ No.:192/13/82‐ No/Date:17/82‐ Re-indexed 195/AM15/ Re-indexed : It was decided to remind the firm to fumish following technical details:

y COA from foreigner supporter Assay of Export Product ＞ 　 　 ぅ No.:192/13/82‐ No/Date:17/82‐ Re-indexed 195/AM15/ Re-indexed : It was decided to remind the firm to fumish following technical details: 15042015 No:30/13/82_ Name:R L FINE CHEM

l ζ Past production vis-a-vis Actual consumption of leaves for the last 3years duly certified by Central Excise Authorities. The case was deferred for 15.04.2015. Re-indexed Re-indered : It was decided to defer the case for 15.04.2015 for comments of Department o Status:Deffered and Re-indexed No.:21/13′ 82- Party Name:JUBILANT Meet No/Date:17/82‐ GENERICS LTD “ 器 星児5剛161/Amy障 筋 器∽ “ η ハmy l蹴 開 ° "Ю ・ %η 躊 15“2∝5 “ 鵬 島児5剛鯰3/AMW鵬 角糀 OЮttzハmy l蹴 辮 Ю田釧 "“ 9B鳳 ,餌2m5 ` ALC4つ014 05022015 Re-indexed 1器3月50畑02″AMl夕 Lic No/Date:0510391357 :05/23/040/00260/AM15/ 126092014 15042015 Status:Deffered PETROCHEM PRIVATE IALC4/2014 and Re-indexed 田 鵬 島児5υ釧 “ 3ハMI「 蔦 競 蕊 蔦 肩

悧 鼎 。 “ Ю 翔%8B席 15Ю4加5

Case No.:158/13/82‐

ALC4/2014 Meet No/Datel1 7/82‐ PHARMACEUTICALS INTERNAT10NAL PVT

Case No:159/13/82-

Meet No/Date:17/82‐ ALC4/2014

Case No.:20/13/82-

ALC4′ 2014 Partv Name:PROLIFE INDUSTRIES LIMITED ALC4/2014 05022015

Case No.:50/13/82-

ALC4/2014 89 Case No.:51/13/82- Party Name:PAYAL Meet N (t/Date:l'l/82- Status:Deffered T10NAL PVT 5 Fne lLic No/Date:0310789678 No/Datc:17/82‐ Name:PAYAL ⌒

11 26092014 Party Name:PAYAL Meet No/Date:17/82- PETROCHEM PRIVATE ALC4/2014 ｄ ｄ 徹 ｄ ｅ ｘ ． ｎ υ 　 ・１ に Ｒ ｅ 1鷺角鵬0加2釧AM剛 顆 ~瞼 謎鰊 3/82‐ F霰淑Ъ淵ざ ,ALC4/2014 '05022015 Party Name:SANO MEDICAL iMeet No/Date:17182- 厩薦蕊蕊戸 ~「 蕩脇而Amy l蹴鼎α mm"5“ 蹴15Ю4矧5 T
卜圏躙T, 1躙児5¨υAm y ~に おNo/DateЮ310789867 :03/94/040/00587/AM15/ ハ ン

Case No.:19/13/82-

Decision:in the light of wrtten comments rece:ved from Department of Chemicals and Petrochemicais vide their U O No 14010/44/2010-Ch ‖dated 12 05 2010,it was decided to revise the norms under Para 4 7 of HBP vl as per detai:s given below or as app‖ ed by the firm′ whicheveris less: Export product Exp Qty SI No lmport items Qty. allowed Ethyl Triphenyl Phosphonium Bromide l kg Tri Phenyl Phosphine 0 780 kg 2 EthyI Bromidc 0 361 kg ― | | 雪尋 器 R ツ得案器晰留:G守群裏期悟讐 de 柵鶴需:馳驚fTttλ驚竃 : udyEtt■ttILI尋氣瓢 :hi ⌒ 1器島場 5υO Ю 54ハMlシ No:52/13/82- No Date:17/82- り

20 1 :p∝he面Jon d N∝ms Com雨“"~~~~¬

Case No.:173/13/82-

1鵬鬼 5血■ 0¨ I Bttlim知5 Pany Name:HINDUSTAN Meet No/Date: l7182- POLYAMIDES&FIBRES ALC42014

Case No.:177/13/82‐

Parw Name:KRISHNA ヽleet No Date:17/82‐ ANT10XIDANTS PVT LTD IALC4/2014 No.:82/:3/82‐ 4/2014 1器疏50Ю Ю 8ダAmy 彫 糀 OЮttθ/AM“ 「 十ド∬鼎 °ⅢO餌 “ m隣 15Ю4知5 RLA File Lic No/Date:04101595H :04'4/040/00160/AM15/ ,0092014 Party Name:TATVA Meet No′1)ate:17/82 CHINTAN PHARMA CHEM IALC4/2014 Party Name:ALEMBIC LIMITED N4eet No/Date:17/82-

Case No.:123/13/82-

ヽ4eet No/Date:17/82‐

Case No.:157/13/82‐

嚇 udy。聾置■「議許乱IЫ Re-indexed 181/AM15/ Name:MALLADI & Re-indexed No:15/13/82‐ Re-indexed File

勁 夕| : It was decided to defer the case for 15.04.2015 for comments of DepMment : It was decided to defer the case for 15.04.2015 for comments of Department f Pharmaceuticals. 「 孫eN∝160/13慇2 ~FPa.NameBAYER Mcet No/Date:17/82‐ Status: Deffered ALC4/2014 CROPSCIENCE LIMITED ALC4/2014 and Re-indexed Decision : It was decided to defer the case for 15.04.2015 for comments of Department of Pharmaceuticals. Ю° 鵬 島児m畑∝Q薦 障危棚 ∽鋭 “ ハm:戸 卜F∬辮 側 “ ""OBれ に加 5 101 Case ffo.:tOililliZ- P",ly N"r"Ul.tlCHEI,t Meet No,D"t.,l?/S2- St"tr" ALC4t2ot4 LABORATORIES LIMITED ALC4t2Ot4 ]eppir""o I los--oz.zori i '" - - Ha Fit. --Jnr-e-eir" lli.Notuut"ol rozs99l6 6.f.. D"r., ,0r/82050,,0r l6411rufl 5/ t,:03t95tc/t0t}o547tAMt5t iOr.rO.ZOr+ i Decision : ln the light of written comments ,"ceirea fro, O"partr"r,t of et arrn-"."utiart. uia" their oM No. 35011/593/2014-Pt(Norms) dated 12.03.2015, it was decided to ratiry norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. SLNo lmport items Qty a‖ 。wed/75 mg tablet CLOPIDOGREL 75MG TABLET N u mber CLOPIDOGREL HYDROGENSULPHATE 99.82 mg RA may take appropriate action as per the decision of Norms Committee. Ю2嚇 願隔扁蕊蕊こ| 1需蘊 F睡璃戸薦~~陶 淑:酬肥TD ⌒ | | PHARN4ACEUTICALS INTERNAT10NAL PVT ILTD l'∽ 2釧5 15ノ 107102014

ROGENSULPHATE 99.82 mg RA may take appropriate action as per the decision of Norms Committee. Ю2嚇 願隔扁蕊蕊こ| 1需蘊 F睡璃戸薦~~陶 淑:酬肥TD ⌒ | | PHARN4ACEUTICALS INTERNAT10NAL PVT ILTD l'∽ 2釧5 15ノ 107102014

2レ | 1器3児50Ю Ю “ AMl, 医ち服 υ0023νAMW F繭 需 Ю田OB3503Bttl,餌 201 Pharmaceuticals. Partv Name:JUBILANT Meet No/Date:17/82‐ GEllERICS LTD ALC4/2014 Re-indered 05022015 : It was decided to defer the case lor 15.04.2015 for comments of Department f Pharmaceuticals. Meet No/Date:17/82- ALC4/2014 05022015 Lic No/Date:0510391459 :05/23/040/00256/AM15/ 07 102014 15042015 rcision : It was decided to defer the case for 15.04.201 5 for comments of Department C&PC. Par,NamcMAHAVIR IMeet No/Date:17/82‐ SYNITHESIS PRIVATE IALC42014 Re-indexed 05022015 Lic No/Date:5210041251 1Defer :52/24/040/00031/AM15/ 107 102014 Date:15042015 to defer the case for 15.04.2015 for comments of Department ⌒ 105器 島児59m037ムMW鵬 ち乳 ∽0258晨MW腔 ∬辮 Ю5Ю3Я455Bttl,04205 No:33/13/82- 4/2014 1珈鶴 ・m"1穆 " Re-indexed IRLA Rた
したNo/DtteЮ 310790KX10 |:03/94/040/00622/AM15/ 08102014 15042015 to defer the case for 15.04.2015 for comments of Department los.oz.zor s PLASTICIZERS LTD,

Case No:182/13/82-

Meet No/Datc:17/82- ALC4/2014 CHEMICALS PVT LTD, ALC4/2014 り 菅鍛 織Ψ D軸

「 申 累熙需踊想 ::颯認fI輩1鷲協 ud菫い轟謀miH R€-indexed 137/AM15/ C&PC No.:179/13782- 182/AM15/ C&PC Name:AVA

23 | 鵬 3鷺5m B5Am" 脇 棚 OЮ “ 26/AM15/~階 趣 踏 α "Ю "∞ ∝ B諸15“2m5 H0 Defrered Re-indexed 15042015 Pharmaceuticals. Paty Name:JUBILANT LIFE Mcct No/Date:17/82- SCIENCES LIMITED ALC4/2014 Re-indexed 05022015 躊鵬魔[鳳:d“ db“ferthe casc bに“ 2m5h conlme蒻ご Departm前 瞼器枷PB慇2 臨棚題U奮皿s Re-indexed 15042015 H3鵬 3児50畑∝弘 Ⅲ夕 陽 糀 oЮmッAm夕 階 だ鼎 Cmm"0躊 15Ю4別5 : It was decided to call from the firm a copy of Master Batch Formula duly by Quality Control In charge. The case was deferred for 05.02.2015. Re-indexed : It was decided to call from the firm a copy of Master Batch Formula duly by Quality Control In charge. The case was deferred for 05.02.2015.

Case No.:162/13/82-

ALC4/2014 Re-indexed : It was decided to defer the case for 29.04.2015 for comments of Department f Pharmaceuticals. 05.02.2015

Case No:35/13/82-

ALC4/2014

Case No.:8α 13/82-

ALC4/2014 Meet No/Date:17/82‐ BIOPHARM PVT LTD ヽ匝Ш亜Ⅷ亜唖 雪尋 柵 Dy網鼎「需 ¨ 鼎黒FT鼎需::窮認f:恕1鵬鍵 u.:■11lL乱:IRttgLlⅢ IMcct No/Date:17/82- Staius:Deffered 15/ 108102014 Pa●y Name:JUBILANT LIFE Mect No/Date:17/82‐ SCIENCES LIMITED ALC4/2014

H6器 3児5叩Ю86ムmy 障角鵬∽∝鍬AM夕 階吻 =“ 血Ь9"21蹴 15餌2m5 2Ч Re-indexed THCAREINDIA 1躙 児5剛 И 9ハm夕 陽 危鵬 ∽ "“ ¨ 「 ∬辮 “ Ю3915111蹴 l知″ ∝5 Pharmaceuticals.

Case No:83/13/82‐

ALC4/2014 : It was decided to call from the firm a copy of Master Batch Formula duly by Quality Control In charge. The case was deferred for 05.02.2015. R€-indexed Lic No/Date:0810133557 1Defer :08/24/040/00259/AM15/ 10102014 Date:15042015 to defer the case for 15.04.2015 for comments of Department Par"Name:CAPLIN PONT Meet No/Date:17/82‐ LA30RATORIES LTD, ALC4/2014 Re-indexed 05022015 15042015 No.:173/13/82- Party Name:ENCUBE Mcct No′1)ate:17/82‐ 14 ETHICALS PVT LTD ALC4/2014 05022015 H91ミ 13児50/01176/AM15プ ll卜:λ月器 0/00627/AM15/ [:「]『][]TE:051o79020913:[1,042015 : It was decided to reject the case because there are very large number of import The firm is advised to send separate applications for separate export product. No.:175/13/82- 階鮮" 4 15042015 : ln the light of written comments received from Department of Pharmaceuticals vide OM No. 35011/483/2014-Pl(Norms) dated January 2015, it was decided to ratiry norms Meet No/Datc:17/82‐ PHARMACEUTICALS No.:275/13/82- Mcct No′Date:17/82‐ PHARMACEUTICALS LTD 田

Case No.:76/13/82-

ALC4/2014 GERMAN ALKALOIDS NamciSHAStlN 5 Name:INDO 厩ら糀 OЮ0644/AMり 階 ∬器 α "Ю 7901紗

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

Export product Exp Qtv SI No lmport items Qtv. allowed IPECACUANHA EXTRACT Concentrate 9% l Kg IPECACUANHA ROOTS 4091k学 a RA concerned may take further necessary action as per above decision of NC. 2ラ Cnse No.:271/13/82- ALC4/2014 1器3児50/O1274ハMly becision:In the light of w No 350H/502/2014-PIso輌 IHBP Vl as per details given b( Pany Namell.lTl\S Meet No/Date: l7182- PHARMACEUTICALS IALC4NOI4 luro.. los.oz.zo t s lnr-e nit. lLic.No/Date:O8l O 13351 J:08t24t040t00260/AMl5t lt r. t o.zo t I i-"@ rs) dated 12.02.2015, it was decided to ratiry the norr low or as applied by the firm, whichever is less: |0 Defer lDate:15.04.2015 rticals vide their OM r under Para 4.7 of Item of Export Quantity S No Item of Import Quantity Allowed DOXYCYCLNE HYCLATE TABLETS 100 MG"DOXINE 100" l tablet l DOXYCYCLINE HYCLATE EP/BP/USP/1P/PH EUR I 17.3 mg mav tat<e appropriate action as per the decision of Norms Committee. ~甲戸=1翌里■剛璽 [図堅 | 22翻面高蕊戸務鵬υ∞η vAm夕 階∬辮Ю mm%田6B窟 1,042015 Pharmaceuticals. . ol Pharmaceuticals. ]of C&PC. り にぬ“ N∝2■月ン82~ IALC4/2014 つ ‘ Status:Deffered No.:272/13/82- Namc:SAIBABA ACTANTS(P)LTD, No/Datc:17/82- Re-indexed 鴨

25鵬疏 50/Ol κ 6ハmy ttt乳OЮ餌 "ハ剛y 厩齋戸而砺琥源蔦蕊 )ecision : It was decided to defer the case for 15.04.2015 for comments of Department fC&PC.

Case No:163/13/82‐

ALC4/2014 %ら Party Name:S.M. CHEMICALS Mcct No/Datc:17/82- ALC4/2014 05022015 Deffered Re-indexed Re-indered 鵬3澪m畑“ 6/AMⅣ 脇 続 Decision : It was decided to remind the firm to fumish the following technical detaiis: l. coA for foreign supplier indicating potency of Nystatin imported under present A.A Dctailed calculation ofarriving at the quantiけOfAPI applicd

Case No.:155/13/82‐

ALC4/2014 C&PC Filc :01/82/050/01127/AM15/ ヽ4eet No/Date:17/82‐ ALC4つ014 Re-indexed 05022015 :It was decided to dcferthe case fOr 15 04 2015 for conlments of Departnent Mcct No/Date:17/82‐ ALC42014 Re-indexed 05022015 case was dcferrcd for 05 02 2015 No:136/13/82‐ P鉗りName:DHANUKA Meet No/Date:17/82- 4 LABORATORIES LTD ALC4/2014 Re-indexed 05022015 Meet No/Datc:17/82- 鯰81棚 児5剛Bttmy膨 慌 ∽ω O殊m夕 陪 淵 r側 "釧 041鵠 5劇川 5 :cision : It was decided to defer the case for 15.04.2015 for comments of Departhent Pharmaceuticals. ALC4/2014 05022015 :cision : It was decided to defer the case for 15.04.2015 fo. corfient, of D"part-ent C&PC.

Case No.:183/13/82-

ALC4/2014 ParりName:BLISS GVS PHARMA LTD Lic No/Date:0310790362 17102014

Case No.:154/13/82-

ALC4/2014 AROMATICS PVT LTD

Case No:124/13/82‐

Pary Name:PANACEA ALC4/2014 BIOTEC LTD, Meet No/Date:17/82- :05/24/040/00319/AM15/ Re-indexed

2η : It was decided to defer the case for I 5.04.2015 for comments of Department

Case No.:135/13/82-

ALC4/2014 1蜆 酬 諄 :cision : It was decided to defer the case for 15.04.2015 for comments of Department C&PC. :011821050/01167/AMl5/ :03195/MO/0O593/AMt5/ t7.tO.2Ot4 Lic No/Date:0310790332 rision : It was decided to defer the case for 15.04.2015 for comment.;f D.p.rt."ra Pharmaceuticals. lecision : It was decided to defer the case for t 5.0+:0t s for "om-ents of Depa.trnent f Pharmaceuticals.

Case No:132/13/82-

ALC4/2014 PなりName:MoREPEN LABORATORIES LTD, t9.tl9 iRtt F.lle Llc.Noroiieos ro:s t6al p.re, p"t", :0r/82/05o/0t t35/AMts/ l:0st2a/o40/0o322tAutst )zo.to.zot+ i ' - -'-' necisio, . f" tf," ,,tn*r "r** * No.-3501 l/3892014-plNorms) dared 20.01.2015, it was decided to ratiry the norms under para 4.7 0f HBP vl as per details given below or as applied by the frm, whichever is less: Export Product ■ 的 帥 Ｑ ｕ ａ ｎ S No Import Item Q″ A‖owed kg/kg Montelukast l kg l (S)‐(E)-2‐[2-[3-(7-chioЮ ‐2- 124 1器3児5∽H3シAM膨 陽 角乳 OЮ0322ハM耐 ALC4つ014 05022015 "l器3児5∽H38晨m夕 陽角乳 OЮ0306/Am:/ F需需戸 而91639B私 5∝2m5

バ Sodium quinolinyl)-ethenylPhenYll-3- hydroxypropyll-phenYll-2- propanol 2 Methanol 2325 3 N,N-DiisopropYlethYlamine 030 4 Tetrahydrofuran 315 Acetonitrile ０ フ つ ´ 6 2‐[1- (MCrCaptomcthyl)CyciOprOpyl] Acetic Acid 040 may take approPriate action as Per decision of Norms Committee. No:145/13/82‐ Name:PAYAL No Date:17/82‐ r lt "t a"aa"a t" Gfo ttt" ." for 15'04'2015 for comments of Department 4′201 Filc 1/82/050/0 No.:139/13/82- 14 一 ― 一 　 　 　 　 　 　 ８ Ｆ Ｉ Ｉ ‐ ‐ ― １ １ ３ ‐ ‐ ‐ ‐ ‐ ‐ ¨ ‐ ４ 　 　 　 一 　 ¨ 輝 ― 臨 ■ ｅ ｍ ■ ａ ｐ ｅ Ｄ ｆ Ｏ ｍ ｅ ｍ ｍ ０ Ｃ わ ５ ０ う ん ４ ０ 一 ‐ ５ Fision:It Was decided to defer the case for PharmaceutiCals 4 ゆ ― ―――――一 ,cOmtnents OfI)epartment :It was decided to deferthe case for 15 04 2015 fol Meet No/Date:17/82‐ Party Name:RECKITT Meet No/Date:17/82‐ BENCKISER HEALTHCARE INDIA Re-indexed Re-indexed

,cOmtnents OfI)epartment :It was decided to deferthe case for 15 04 2015 fol Meet No/Date:17/82‐ Party Name:RECKITT Meet No/Date:17/82‐ BENCKISER HEALTHCARE INDIA Re-indexed Re-indexed

L1 et Phannacerrt,cal$ I No.:169/13/82- Party Name:YASHO Meet No/Date:17/82- INDUSTRIES PVT LTD ALC42014 Re―indexed Partv Name:ALEMBIC Meet No/Date:17/82‐ PHARMACEUTICALS LTD IALC4/2014 Re-indexed 05022015 Pharmaceuticals. 4 05022015 Lic No Date:0310790376 :03/95/040/00602/AM15/ 120102014 15042015 Party Name:DORF-KETAL Meet No/Date: l7182- CHEMICALSINDIA ALC4/2014 R€-indexed PVT LTD 05022015 )ecision : It was decided to defer the case for 15.04.2015 for comments of Department fC&PC. Meet No/Date:17/82‐ Name:GULBRANDSEN IALC42014 Re-indexed CHEMICALS PVT LTD 05 02 2015 15042015 No.:167/13/82- Party Name:S M B Meet No′ Date11 7/82- 14 CORPORAT10N OFINDIA IALC4/2014 Re-indexed 05022015 Lic No/Date:0310790431 :03/95/040/00610/AM15/ 121 102014 15042015 No.:130/13/82- 4/2014 `4器3児5剛Bttmヌ 膨刷 :o側"罵百~囲 陶戸両面 [蔦蔦訂

Case No.:153/13/82-

ALC4/2014

Case No.:129/13/82‐

ALC4/2014 15042015 156/AM15/ 132/AM15/ No.:171/13/82- Name:PRASOL No/Date:17/82- Re-indexed

多ο ハ И6鵬 島児m畑″夕Am夕 隔λ帖 OЮ "OAmy囲 開 ° “ Ю "餌 Ю 跳角鵬 υOm 7ツAMⅣ 階だ器 3引0040637Bttl,042m5 15042015 )ecision : It was decided to defer the case for 15.04.2015 for comments of Department fC&PC.

Case No.:170/13/82-

Partv Name:SAVLA ALC4/2014 CHEMICALS LIMITED Re-indexed )ecision : It was decided to defer the case for 15.04.2015 for comments of Department fC&PC. Re-indered Status:Deffered and Re-indexed to defer the case for 15.04.2015 for comments of Department No.:110/13/82- 4/2014 Party Name:TATVA Meet No/Datc:17/82‐ CHINTAN PHARMA CHEM IALC42014 ]nq rit" Re-indexed 05022015 15042015 Re-indexed Parw Name:INTAS Meet No/Date:17/82‐ PHARMACEUTICALS ALC4/2014 Re-indexed LTD, 05022015

Case No.:172/13/82-

ALC4/2014 Party Name:PRASOL CHEMICALS LIMITED Meet No/Date:17/82‐ Meet No Datc:17/82- No:116/13/82‐ ;43 IHQ File :01/82/050/01119/AM15/

Case No.:87λ j/82-

Mcct No7Date:17/82- ALC4/2014 Cnse No.:276/13/82- ALC4/2014 jnr-e rite Lic.No/Date:08 I 0 I 33688 ]Defer C&PC Name:SHANPAR No/Datc:17/82‐

ζヽ 中 "漏 扇ラーーЮ8/24/040Ю0288/AMlラ~~~,8102014 ~IDac29 042015 Pharmaceuticals. Ｆ ‐ ‐ ‐ ５ ３ ‐ ‐ rDecision : It was decided to defer the case for 15.04.2015 for comments of Department rof C&PC.

1器3児5∽H4夕AMⅣ 陽允監 OЮ032ンAmy Decision : ln the light of written comments received from Department of pharmaceuticals vide their oM No. 35011/403/2014-Pt(Norms) dated 22.01.2015, it was decided to ratiry 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 kg/kg CeFuroxime Axetil amorphous Stearic Acid Coat 15%POwder l kg 1 7 ACA (7 Amino Cephalosporanic Acid ) 01265 2 Phosphorous Penta Chloride 0]522 3 SMIA(Z)2- Methoxyimin∝Furyl-2- yl)Acctic Acid O1310 一 : It was decided to defer the case for 29.04.2015 for comments of Department No:125/13/82- No/Date:17/82‐ C&PC No:126/13/82- No/Datc:17/82‐ No:141/13ノ82- Name:YASHASHVI No/Date:17/82- YAN PVT LTD File Pharmaceuticals. No/Datc:17/82- r: Approved D"t*

or comments of Department No:125/13/82- No/Date:17/82‐ C&PC No:126/13/82- No/Datc:17/82‐ No:141/13ノ82- Name:YASHASHVI No/Date:17/82- YAN PVT LTD File Pharmaceuticals. No/Datc:17/82- r: Approved D"t*

3ン Ammonium Salt 4 Methanol 0156 5 Methylene Chloride 0537 6 Chlorosulphonyl Isocyanate 00832 7 Acetone 0462 8 Tetra Methyl Guanidine 00322 9 N,N Dimcthyl Acetamidc (DMAC) 0287 匡 10 Ethvl Acetate 0351 11 Stearic Acid 08455 12 Acetic Acid 000753 Activated Carbon 0016 may take appropriate action as per the decision of Norms Committee. il 継淵 釧ル

押 柵 脚 器 圏 rdル ド 嘔 “ proved 器3鬼5剛 `6ハmy囲 0畑 "″ Amy[ド ∬器 がЮttTttDな ° Decision::n the!ight of written comments received from Department of Pharmaceuticais vide ther OM No 35011/425/2014-Pl(Norms)dated February 2015,l was decided to raJfy norms under Para 4 7 of HBP vl as per deta‖ s given below or as applied by the lrm′ whicheveris less: 156 Item of Export Quantlty S′ No Item of lmport ｇ ゴ ｔ ｙ ｄ ｋ ｔ ｉ 　 ｅ ｕ ａ ｎ ‐ ｏ ｗ Ｑ ａｌ CEFUROXIME AXETIL AMORPHOUS STEARIC ACID COATED 30% POWDER l kg 1 7 ACA (7 Amino Cephalosporanic Acid ) 0253 2 PHOSPHOROUS PENTA CHLORIDE 03044 3 (Z)2-Methoxyimino― (Fuッl‐2-yl)Acetic Acid Ammonium Salt(SMIA) 0267 4 METHANOL 0311 ¨ ５ Methylene Chloride 1075 6 CHLOROSULPHONYL ISOCYANATE O166 7 ACETONE 0925 8 TETRA METHYL GUANIDNE 0064 9 N,N DIMETHYL ACETAMIDE 0574 り udソ祟11露フL瓢』蔦 「 1∫Llhl

monium Salt(SMIA) 0267 4 METHANOL 0311 ¨ ５ Methylene Chloride 1075 6 CHLOROSULPHONYL ISOCYANATE O166 7 ACETONE 0925 8 TETRA METHYL GUANIDNE 0064 9 N,N DIMETHYL ACETAMIDE 0574 り udソ祟11露フL瓢』蔦 「 1∫Llhl

33 )ecision : It was decided to defer the case for 15.04.2015 for commenir & D-purtm.nt f Pharmaceuticals. 「 1濶 " HQ Fne :0 I /82t05O/0 1269 t AM I 5 / ):08/24r040t0o289/ AM t 5 / C&PC :It、vぉdecided tO deferthe case for 15 04 2015 for comments ofDepartment 10 ETHYL ACETATE 0702 11 STEARIC ACID 06849 12 Acetic acid 00151 （ ３ ACTIVATED CARBON 00314 14 POLY VNYL PYRROLIDONE K 25 000084 RA may take appropriate action as per the decision of Norms Committee. Status:Deffered Lic No77Date:0810133735

Case No:268/13/82-

ALC4/2014 | | lυ D uz.zυ :D 鵬 島児 "畑 η 1/AM Ⅳ 陽角北 OЮ∽ “ ハm夕 賭 ∬鼎 。∝Ю 133734 lmぽ Aコ Status:Deff€red and Re-indexed 15042015 Ｆ Ｌ ド ‐ ‐ )ecision:It was decided tO deferthc casc for 15.04 2015 for conlments OfDepartment fC&PC was decided tO deferthe case for 15 04 2015 for cOmments Of Department 町 ／ [彎シ1濶岬2岡鱚 橿l塁塁型lR堅 膨鵬OЮm%ムm夕 1拙 5“訓5 肝認 ど・ m側面嗣 tO d畿品∝雛bに “ 知J面 高 品 。fD"armm No.:104/13/82- :1珈 1310047687 107/AM15/ No77Date:17/82- 124/AM15/ .11.2014 lDate:15.04.2015

Ъ｀ ⌒ FfC&PC ~~ | Ｆ Ｉ Ｉ Ｉ Ｉ Ｉ ‐ ６ ２ C"* N"rj26?/13/82- Farty Na."ELIXIR F..t M/D"t.j?/82. Etr" ALc4not4 lnHlnul letcqnotq lepproved I los.o2.2o r 5 I Ha File FLA Ftl" ILt"N"/D"t.08 t 0t 33?43 F;fer Date, '.ottl2tosototz7otAutst ):0824to4otoo2g4t AMt St lo7.|.2014 1 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No.

tz7otAutst ):0824to4otoo2g4t AMt St lo7.|.2014 1 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 3501I1422D014-PI(Norms) dated 06.02.2015 and in consultation with technical authority present in meeting decided to rati! norms under para 4.7 of HBP as per details below or as applied by firm whichever is Export product Exp Qty SI No lmport items Qty Allowed Kqノkg 3-Isobutyl(〕lutaHc A^:■/ハヽrII n:^^:J、 lkg 1 Isovaleraldehyde 06068 Aじlu kしlVIn ν 14しlu′ う ４ Ethyl Cyanoacetate 07814 3 Diethvl Malonate 09784 concerned may take further necessary action as per above decision of NC. No.:1/13/82- Ptt Name:HETERO LABS LIMITED : It was decided 1“ 1飛ら鵬 OЮ0290ハmヌ「渕画面 Meet No′つate■7/82‐ ALC4/2014 Re-indexed 05022015 Lic No Date:0910061188 :09/24/040/00417/AM15/ 107 112014 to defer the case for 15.04.2015 for comments of Department Deffered Re-indexed : It was decided to deler the case for 15.04.2015 for comments of Department 腰席" Re-indexed

Case No.:2/13/82-

ALC4/20:4 Party Name:ATUL LIMITED, ALC4/2014 05022015

Case No.:3/13/82-

ALC4/2014 “5囲蕊蕊戸囲淋蕊戸階∬開°酬∞ a'71蹴 l,“2∝5 「 :11::l‖l就:Ill::CideTtodeferthecasefor15b民'O15 for conllncnts ofDcpartment DefFered Name:HJ AROCHEM No7Datel1 7/82- Re-indexed Defer Date:15042015

Case No.:26y13/82-

ALC4/2014

ヽ 3S~ 鵬 3児 "畑 %νAmシ 隔危鵬 OЮの “ /AMW階 ∬開 °∝Ю B"“ 蹴 1,∝2∝5 )ecision : It was decided to defer the case for 15.04.2015 for comments of Department fC&PC. ]麟… Re-indexed Pharmaceuticals.

Case No.:114/13/82‐

Status:Deffered ALC4/2014 ,nd Re-indexed RLA Flle :52/24/040/00042/AM 15/ 15042015 一 　 　 ‐ ７ ０ ccision:In the light of w‖ tcn comments rcccived from Dcpartment of AYIJSH vide thcir F o T 12016/2/2015‐ DCC(AYUSH)dated 23 03 2015,■was decidcd to request thc fli‖ i to at the earliest details of the herbal extracts used in formulation as required in Drug & Rule 158 B for consideration of fixation of norms. The case was deferred for 15042014 Re-indexed Re-iDdexed 田 3児5υm∞7晨my障 危棚 0/0。4"ハm夕 「 F∬鼎 α酬 ∞御釧1蹴 1,“ 2創5 田霜瓢聴奮F面葛面面酷二`¨面 15 Partv Name:VIRDEV INTERMEDIATES PVT LTD “ 8器疏50/OI H:蔦蔦 f Pharmaceuticals. No:151/13782- Name:REANNON No/Date:17/82‐ C&PC No.:111/13/82- Name:ABEERS No/Date:17/82- No:4/13/82- Name:ASTRIX No/Datc:17/82- TORIES LTD, No:5/13′ 82- Namc:ASTRIX No/Date:17/82‐ TORIES LTD, 鵬 疏 50/Ol15″ Am夕 脇 乳 ∽ “ 釧晨m夕 「 ∬器 C"Ю "∝ η 隣 15Ю42釧5

フ6 fC&PC Deffered Re-indexed 15042015 No.:112/13/82‐ Party Name:SOLARIS Meet No/Date:17/82‐ CHEMTECH NDUSTRIES ALC4/2014 Re-indexed LTD 05022015 Lic No/Date:3410040672 :3424/040/00193/AM15/ 1l H 2014 15042015 Meet No/Datel1 7/82‐ ALC4/2014 Re-indexed 05022015 15042015 Pharmaceuticals. Party Name:JUBILANT LIFE Meet No/Date:17/82‐ SCIENCES LIMITED ALC4つ014 Re-indexed 05022015 f Pharmaceuticals. No.:105/13/82- 4/2014 Party Name:PAYAL Meet No Date:17/82‐ PETROCHEM PNVATE IALC4つ014 Re-indexed 05022015 Lic No′ 1)atc10510391957 :05/24/040/00336/AM15/ 12 112014 15042015 Party Name:JUBILANT GENERICS LTD Re-indexed 14112014 :15042015

et No Date:17/82‐ PETROCHEM PNVATE IALC4つ014 Re-indexed 05022015 Lic No′ 1)atc10510391957 :05/24/040/00336/AM15/ 12 112014 15042015 Party Name:JUBILANT GENERICS LTD Re-indexed 14112014 :15042015 Decision : It was decided to defer the case for 15.04.2015 for comments of Department of Pharmaceuticals. 4 口5鵬 島‰ 畑23晨剛 夕
階 ∬器 α “ Ю "り ″ Ettl,“ 2m5

Case No.:7/13/82-

ALC4/2014

Case No.:120/13/82-

ALC4/2014

Case No.:119/13/82-

ALC4/2014 … 3■1ヽ/N[RMAL Кυ MAR 108/AM15/ ^ C&PC ヽ

′ ¬ Party Name:HETERO Mcet No/Date:17/82-

Case No.:9/13/82-

ALC4′ 2014 DRUGS LIMITED ALC4/2014 Re-indexed 05022015 Pharmaceuticals. Re-indexed 3 It was decided to defer the case for 15.04.2015 for comments of Department Pharmaceuticals. 厠 漱2 Re-indexed Re-indexed Pharmaceuticals. 雪黒品路器 R ud菫聾蘊謀瓢 m rcision : It *as aecided to defer the case for 15.04.2015 for comments of Department C&PC.

Case No.:123/13/82-

Party Name:PAYAL Meet No′1)ate:17/82 ALC4/2014 PETROCHEM PRIVATE .ALC4/2014 105022015 :It was decided to deferthc casc for 15 04 2015 for conlmcnts ofDepartment 開蕊蕊冨蕊yF雨飛よいЮ 3920821蹴 15Ю42釧5 | 一 　 　 ‐ ８ ３ Re-indexed 20112014 :It、vas decided to dcfcrthe case for 15 04 2015 for comments ofI)cpartmcnt

Case No.:10/13782-

ALC4/2014 Ptt Namc:HETERO LABS LIMITED ALC4泡O14 05022015

Case No:11/13/82-

ALC4/2014

Case No:122/13/82‐

ALC4ノ2014 No/Date:17/82- :01/82/050/01013/AM15′ C&PC C&PC

Case No:91/13/82‐

ALC4/2014 37 Party Name:INCHEM Meet No Datel17/82‐ LABORATORIES PRIVATE ALC4/2014 LIMITED 05022015 Meet Nol)atel1 7/82- Meet No/Date:17/82‐ ALC4泡014 05022015 Meet No′1)atc:17/82- Status:Deffered 闊 田 3‰ 畑 "″ A剛夕 1脇 図 瓦ヽmy囲 鼎 αttm露 7 05022015 Re-indexed 15042015 Re-indexed 15042015 and Re-indexed 15042015 )cision : It was decided to defer the case for 15.04.2015 for comments of Deparrment Pharmaceuticals. No:97/13/82- 4 ALC4/2014 05022015 maytake appropriate action ffi :cision : It was decided to defer the case ro. ts.o+:ots ro. comrn"nts or o"pa.t nert Pharmaceuticals. ALC4つ014 :cision : It was decided to defer the case fo. t@ Pharmaceuticals. υdy郎轟瓢誡 :H Lic No/Date:0910o61306 25 112014 :rsron : In the light ofw tten comments received fiom Department of pharmaceuticals vide their oM 3501l/47'l /2014-Pr (Norms) dated February 20r5, it was deiided to ratiry the norms under para 4.2 of vl as per deta‖ s given below Or as applied"the■●n,whichevcr ls iess■ MEROPENEM FOR INJECT10N (MEROPENEM STERILE) Meropenem Trihydrate (Non Sterile) Aluminium Canisters

Case No.:93/13/82‐

ALC4/2014 Party Name:HETERO DRUCS LIMITED Name:AUROBINDO tMA LIMITED HQ Filc :01/82/050/01100/AM15/ 隔危棚蕊餌 57ハm夕 Defer Date: Export product ピ“ SI No Importitemi- 1脳1」|° WCd l kg l 0987 つ ι Carbon Enoanticromos (Activated Carbon) 0049 Acetone 264 4 Methanol 00958 Relevant as per packing policv

タタ B8鵬 3掲50畑 "7Am y 膨 淵 OЮ “ 69/AMW 医 ∬鼎・ 酬∞a mo躊 15∝2m5 Party Name:HETERO DRUGS LIMITED

Case No:94/13/82-

ALC4/2014 f Pharmaceuticals. Pharmaceuticals. Mcct No/Date:17/82‐ Status: Deffered and Re-indexed 吻 ~ Deffered Re-indexed 博9鵬 3掲 "Ю Ю%ハm夕 陽角糀 OЮ餌 “ ムm夕 階∬開 °酬∞a期 齋 6“ 2m5 ALC4/2014 05022015

Case No.:95/13/82-

ALC4/2014 Patty Name:HETERO LABS LIMITED Re-indexed Lic No/Date:0910061302 :09/24/040/00466/AM15/ 125 112014 Decision : It was decided to defer the case for 15.04.2015 for comments of Department of Pharmaceuticals. 甲… 赫腋鮮" No:96/13/82- 1/2014 「F蕊需面 「 ~~ り 11器 3児50/O H02/AMl夕

Case No:100/13/82-

ALC4/2014 Mect No/Date:17/82‐ Status: Deffered ALC42014 and Re-indexed 05022015 )ecision : It was decided to defer the case for 15.04.2015 for comments of Department f Pharmaceuticals. Status: Deffered and Re-indexed : It was decided to defer the case for I 5.04.201 5 for comments of Department Pharmaceuticals. Meet No/Date:17/82- 驚剰鰤 ALC4/2014 05022015 り 31器 3児50Ю HOシAMW Ъ角鵬OЮ“ 87晨my厩 渕 崎 厩 蕊 Party Name:HETERO ~~開 瑠輛戸面而雨雨 B諸15“ 2015

Case No.:102/13/82-

ALC4/2014 Paty Name:DR REDDYS LABORATORIES LIMITED LIMITED Name:HETERO LABS No/Date■7/82- File Ｆ ‐

″つ ALC4/2014

Case No:280/13/82‐

Party Name:HETERO LABS Status:D€ffered LIMITED and Re-indexed f Pharmaceuticals. Lic No′lDate:0910061365 :09ノ24/040/00499/AM15/ 109122014 15042015 to defer the case for 15.04.201 5 for comments of Department

Case No:282/13/82-

Partv Name:HETERO LABS Deffered ALC4/2014 LIMITED Re-indexed 15042015 f Pharmaceuticals.

Case No.:283/13/82-

Partv Name:HETERO LABS Meet Nαl)ate:17/82- ALC4/2014 LIMITED ALC4/2014 05022015 :15042015 Pharmaceuticals. No.:279/13/82- Pary Name:HONOUR LAB Meet No/Date:17/82- 14 LIMITED ALC42014 Re-indexed 050220!5 194FR履F17:ここ :こ五 I戸 ~~|ヽし た場器 0/00498/AM15/ 「 「電電 Ttte:0910061j64[;:ll,042015 り8器 3鬼5υm282/AM W陽 危服 OЮOЯ OAmy囲 ~F淵朝ル Lic No/Date10910061362 15042015 f Pharmaceuticals. Re-indexed Meet No/Date:17/82‐ : It was decided Meet No/Datc:17/82- ud語男轟瓢瓢 :ふ Re-indexed Filc Name:HONOUR LAB No/Date:17/82‐

ヽ | Out Side agenda Part B‐ ::

Case No. A- 1

lv{/s. Mepro Pharmaceuticals P}t Ltd Mee‖ng No 17/AM15 dated-17032015 F No01/82/162/00114/AM15/DES― IⅡ RAF No 03/86/040/00252/AM 11 Adv Lic No 0310621914 datcd 18 03 2011 Decision : In the light of written comments of Department of Pharmaceuticals and in consultation with technical authority present in meeting, it was decided to revise the norms under as per details below or as applied by firm whichever is lower:- Based on the above norms RA may workout the export obligation in terms of Aciclovir imported under the prescribed Advance Authorization. RA concemed may take further necessary action as D€r above decision ofNC. Export product Export ow. SI No Import items Qty. allowed Medicinal Cream Ointments:- Aciclovir 5% l0 gm Cream Nos l Aciclovir BP/USP/1P/EP/1H 0.51 gm/tube Medicinal Cream Ointments:- Aciclovir 5% 200 mg tablet Nos l Aciclovir BP/USP/1P/EP/1H 204.0 m/rablet Medicinal Cream Ointments:- Aciclovir 5% 400 mg tablet Nos 1 Aciclovir BP/USP/1P/EP/1H 408 0 mg/tablet

Case No B-1

N4/s. Ajanta Pharma Ltd Meeting No.l7lAM l5 dated - 17.03.2015 F No01/82/050/00004/AM05/DES‐ III RAF No 03/24/040/027:4/AM 04 Adv Lic No 0310262053 dated 31 03 2004 Decision: Committee considered the case as per agenda and in consultation with the technical authority present in the meeting and it was decided to amend the description of export product without any other changes as per details given below: RA may take appropriate action as per the decision of Norms Committee. From To AMOXYCILLIN AND CLAVULANATE POTASSIUM TABLET(CONTANING‐ ―… 1 MG AMOXYCILLIN TRIHYDRATE-575 MG AND CLAVULANATE POTASSIUM 135 87 MG) AMOXYCILLIN AND CLAVULANATE POTASSIUM TABLET (EACH FILM COATED TABLET CONTAINS AMOXYCILLIN TRIHYDRATE EQ TO AMOXYCILLIN 500MG AND CLAVULANAπ POTASSIUM EQ TO CLAVULANIC ACID 125 MG) ] 可,国會■■o・J・八。Ⅲ■.I■,nrrere9 ヽ

Ч2 M/s. Charm Cosmetics P;ivate Limited Meeing No 17/AM15 dated-170312015 F. No.0 I /821050/0045 I /AI\404/DES-XI RAF No 03,4Ю 40/009o8/AM 04 Adv Lic No 0310218428 datcd 12 08 2003 Decision: lt was decided to deferthe..r@ lWs. Paramount aromactrem pvt Ltd MeeJng No 17/AM15 dated-17032015 F. No.0 I /82/050/0 1 246lAMt 3/DES-IX RAF. No. 05/241040/0038 yAM 13 Adv Lic No 0510343720 dated 18 01 2013 Decision: lt was decided to deferthe..@ M/s. Deepak Nit.ite Limited Meeing No 17/AM15 dated-17032015 F. No.0 l/821050/0 I 000/AM I 2/DES-ilI MF. No. 3 l/83/040/00t37 I AMIJ Adv. Lic. No. 3l 10052056 dated 2Ltnon Decision: lt was decided to defer the M/s. Navin Fluo.ine InternationalTimited MeeJng No 17/AM15 dated-17.032015 F.

I 2/DES-ilI MF. No. 3 l/83/040/00t37 I AMIJ Adv. Lic. No. 3l 10052056 dated 2Ltnon Decision: lt was decided to defer the M/s. Navin Fluo.ine InternationalTimited MeeJng No 17/AM15 dated-17.032015 F. No.0 r /821050/00446/AMis/DES_tX RAF. No. 03/95/040/00t15/AM- l4 Adv. Lic. No. 0310772674 dared03J320l4 Decision: It was decided to a"fe, th" M/s Hindustan P61yamides&Fibres Limited Meelng No 17/AM15 dated_17032015 F. No.O r/rzlos0/oo5r o/aMTyDsS_ru RAF. No. 03/941040/00l32/Atv{ l5 Adv Lic No 0310783464 datcd 29 05 2014 DecisiOn:lt was decided tO deferthe case for comments Of Departrnent Of c&Pc

Case No B-7

M/s Hindustan P。lyatnides&Fibres Limitcd Meelng No 17/AM15 dated-17032015 F No01/82/050/00182/AM15/DES― III RAF No 03/94/040/00835/AM 14 Adv Lic No 0310765125 dated 08 01 2014 Decision: lt was decided to defer the case for comments of Department of C&PC.

Case No B‐ 8

M/s. Indo Phyto Chemicals Prt Ltd Meeting No 17/AM15 dated-17032015 F No01/84/050/00318/AM13/DES― III RAF No 05′ 23/040/00252/AM 13 Adv Lic No 0510336430 dated 04 10 2012 Decision: lt was decided to defer the case for comments of Department of Pha rmaceuticals.

Case No. B- 9

M/s AVA Chemicals Pvt Ltd MeeJng No 17/AM15 dated-17032015 F No01/82/050/00793/AM14/DES― III RAF No 03/94/040/00485/AM 14 Adv Lic No 0310749510dated 13 092013

Case No B-10

M/s AVA Chcmicals P宙Ltd Meeung No 17/AM15 dated-17032015 F No01/82/050/00864/AM13/DES― IH RAF No 03/94/040/00448/Aヽ1 13 Adv Lic No 0310709883 datcd 21 09 2012

Case No B-11

M/s DoriKetal Chemicals lndia Pvt Ltd Meelng No 17/AM15 dated-17032015 F No01/82/050/01242/AM15/DES-lH RAF No 03/94/040/00390/AM 15 Adv Lic No 0310787602 dated 04 08 2014

Case No B-12

Mノs DoriKetal Chemicals lndia PⅥ Ltd 雪尋 僻 D瑶野窯鴨宰繹編撃 柵鶴濡:電鴛fT習1駐 udPTI t森誡 :“

趾 ゝЦ MeeJng No 17/AM15 dated-17032015 F No01/82/050/01243/AM15/DES― IⅡ RAF No 03/94ノ040/00241/AM 15 Adv Lic No 0310787845 datcd 08 08 2014 Decision: lt was decided to defer the case for comments of Department of C&pC.

Case No B‐ 13

M/s Atul Bioscicncc Lilmited MeeJng No 17/AM15 dated-17032015 F No01/82/050/00574/AM15/DES― HI F No01/82/050/00575/AM15/DES― III RAF No 5224/040/00035/AM i4 RAF No 52/24/040/00039/AM 14 Adv Lic No 5210040850dated 25 03 2014 Adv Lic No 5210040851datcd 25 03 2014 Decision: lt was decided to defer the case for comments of Department of C&pC.

Case No B-17

M/s. Alkaloids Corporation MeeJng No 17/AM15 dated-17032015 F No01/82/050/00930/AM 1077DES-lH

Case No B-14

M/s Vivimed Labs Limited Mee■ng No 17/AM15 dated-17032015 F No01/82/050/00019/AM15/DES― III RAF No 09ノ24/040/00598/AM 14 Adv Lic No 0910059372 dated 21 02 2014 Decision: lt was decided to defer the case for comments of Department of C&pC.

Case No B-15

M/s. Ruchi Infrastructure Ltd Mee■ng No 17/AM15 dated-17032015 F No01/82/050/00409/AM14/DES― III RAF No 5624/040/00005/AM 14 Adv Lic No 5610002272 dated l1 06 2013 Decision: lt was decided to defer the case for comments of Department of C&pC.

Case No B-16

M/s. Ruchi Infrastructure Ltd Mee■ng No 17/AM15 dated-17032015 F No01/82/050/00744/AM14/DES― IⅡ RAF No 56/24/040/00010/AM 14 Adv Lic No 5610002426 datcd 04 07 2013 Decision: lt was decided to defer the case for comments of Department of C&pC. 軸 顎 R

Ч ' RAF No 02/24/040700127/AM 10 1 Adv Lic No 0210131698 dated 18 09 2009

Case No B-18

M/s FDC Ltd Meelng No 17/AM15 dated-17032015 F No01/82/050/00740/AM13/DES― III RAF No 03/94/040/00374/AM 13 Adv Lic No 0310706515 datcd 27 08 2012 DedJon:In the light of、vTitcn commellts received frOm Dcpartmcnt of Pharmaceuticals vidc their OM No 350H/07/2013‐ PIINonlns)dated 12 03 2015,it was dccided to rati取 no■11ls under Para 4 7 of HBP vl as per details given below or as applicd by the f11..., 、vhichcvcr is less: Export product Exp Q″ SI No Import items Qty. allowed ORAL R[HYDRAT10N SALT(ORS) l kg l Sodiurn Citrate 2.9 gm 2 Glucose Anhydrous 13.50 gm 3 Printed Laminate 2.017 gm Remaining inputs namely CITRIC ACID ANHYD and NEOTAME POWDER are not reflected as input in the DML accordingly not allowed. RA may take appropriate action as per the decision of Norms Committee.

Case No B-19

M/s GJaxy Surfactants Ltd Meeing No 17/AM15 dated-17032015 F No01/82/162/00270/AM14/DES-lII

Case No B-20

M/s. Chempo Group Mee■ng No 17/AM15 dated-17032015 F No01/82/162/00355/AM14/DES― III RAF No 03/83/040/00104/AM 14 Adv Lic No 0310741106 datcd 11 07 2013 喘 ●■[ヽ′N[RMAL KuMAR DメDirectO「 那臨 l臨i諸糧 鋪 t剰甜よ輛Of Fore19n Trade 理関暮窮窯劉T

″ι

Case No B-21

M/s. Gulbrandsen Chemicals Mee■ng No 17/AM15 dated-17032015 F No01/82/162/00329/AM14/DES― ⅡI

Case No B-22

M/s. Gulbrandsen Chemicals Meeting No.17/AM15 dated - 17.03.2015 F No01/82/162/00328/AM14/DES― III

Case No 3‐ 23

M/s. Gulbrandsen Chemicals MeeJng No 17/AM15 dated-17032015 F No01/82/162/00331/Aヽ414/DES― HI

Case No B‐ 24

IWs. Gulbrandsen Chemicals Mee■ng No 17/AM15 dated-17032015 F No01/82/162/00330/AM14/DES― III

Case No B‐ 25

M/s Belchem lnds lndia P、l Ltd MeeJng No 17/AM15 dated-17032015 F No01/82/050/00955/AM14/DES― III RAF No 03/94/040/00633/AM 14 Adv Lic No 0310755691 datcd 28 10 2013

Case No B-26

M/s Amdaa Vis Labs Private Limited Meeting No 17/AM15 dated-17032015 F No01/82/050/00385/AM14/DES-111 RAF No 04/24/040/00067/AM 14 Adv Lic No 0410147616 datcd 28 06 2013 Decision: lt was decided to defer the case for comments of Department of Pharmaceuticals. 雪勢 柵 叫網 器 営 器譜冨矯::::1鳥flttλ鷲出 ud癬話鳳 `『tξ添■:“ t

4t

Case No B‐ 27

M/s. Survival Technology Pvt. Ltd Meeting No.17lAM15 dated - 17.03.2015 F No01/82/050/00133/AM12/DES‐ lH RAF No 03/95/040/00536/AM 14 Adv Lic No 0310678569 dated 25 01 2012

Case No B‐ 28

M/s Makson lnds Pvt Ltd Meeting No.17lAM15 dated - 17.03.2015 F No01/82/050/00889/AMi3/DES-lH RAF No 03′95/040/00394/AM 13 Adv Lic No 0310710561 datcd 26 09 2012 Decision: lt was decided to defer the case for comments of O/o DC(MSME).

Case No B-29

Iv{/s. Alchymars Icm Sm Private Limited Meeting No.17lAM15 dated - 17.O3.2O75 F No01/82/050/00111/AM14/DES― IH RAF No 04/24/040/00279/AM 13 Adv Lic No 0410144366 datcd 25 03 2013 Decision: lt was decided to defer the case for comments of Department of Pharmaceuticals.

Case No B-30

M/s. DR REDDYS LABORATORIES LIMITED Meeting No.l 7/AM l5 dated - 17.03.2015 F No 01/83/050/00944/AM12/DES-lH RAF No 09/24/040/00381/AM12 Adv Lic No 0910049902 datcd 24 11 2011 Decision : In the light of written comments of Department of Pharmaceuticals and in consultation with technical authority present in meeting, it was decided to revise the norms under as per details below or as applied by firm whichever is lower:- RA concemed may take further necessary action as per above decision ofNC. Export product Export Qty. SI No Import items Qty. allowed ks/ke Dipyridamole Extended Release and Acetyl Salicylic Acid Capsules (200mq+ 25me) l lakhs Nos l Dipyridamole PH EUR 20.00 kg

雪 協鐸 `覆・ 驚珊 H .藤喫唾望?哺諸語 糖害詩墨聾嗜警寝黎 「Te Date:0502.2015 Nl.11lal Kumar udい 9●haWan, 饒 黒瓢耐 Place:New Delhi Dy. Director General of Foreign Trade