DGFT Committee Minutes
Office of Dircctorate Gcncral of Forcign Tradc Ncw Dclhi -0
Para 4.7 Dccision (DRAFT)
MEETTNG NUMBER : l/82-ALC4/2015 MEETING DATE: 15.04.2015 But actually held on 29.04.2015 Meeting No. 19182 of 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 18.03.2015 but actually held on 29.04.2015 under the Chairmanship of Shri Jaikant Singh, Addl. DGFT in Room No.11, Udyog Bhawan, New Delhi. Following members were presenti Shri Nirmal Kumar, Deputy Director General of Foreign Trade 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. 19/82 was scheduled for 18.03.2015 but actually held on 29.04.2015 and approved the same. The following cases/issues were discussed and the committee look the decision as mentioned against each case. Casc No:30/13/82- IPalty Nainnc:HALDIA Iヽ4cct No/Datc:1/82- ‐ ALC4/2012 PETROCHEMICALS IALC4/2015 LTD IRLA F‖ c Status: Dcflcrcd and llc-indcrcd Stfl tus: Dcllcrcd xnd llc-indcrc(l :15.042015 lLic No/Datc1021 01 7751 8 1DcFcr l HQ File 1 101/82/050/00365/AM13/ :02/24/040/00029/AM13/ 114052012 1)atc:20052015 1 1Dccision:It was dccided to dcfcrthc casc for 20 05 2015 for coinmcnts ofDcpartmcnt ofC&PC I(PC D市ision) Cnsc No.:24/1/82- Al,C4ノ2015 Party Namc:VIJAYASRI 10RGANICS LTD IMcct No/Datc:1/82‐ IALC4/2015 115042015 21HQ Filc RLA File ILic No/Datc:091005346S I)oたr :01/82/050/01550/AM15/ :09/71/040/00073/AM13/ 109082012 I)atc:20052015 Dccision : It was decided to defer the case for 20.05.2015 for comrnents of Dcpartmcnt o f Pharmaceuticals. Casc No.:25/1/82- Pa“ y NamciVI」AYASRI Mcct No/1)atc:1/82- Status:Dcffcrcd l ALC4/2015 0RGANICS LTD ALC4/2015 and Rc― indc、cd | 115042015 1RLA F‖ c iLic No/Datc:0910056835 1DcFcr :01/82/050/01551/ノヽヽ415′ :09/24/040/00152/ノヽヽ414/ 19072013 1)atc120 05 2015 Dccision : It rvas dccided to defer the case for 20.05.2015 for comments of Departrncnt o f Pharmaceuticals. 31HQ Filc 鵬
⌒ Casc No.:82/5/82_ ALC4/2014 HQ Filc :O1/82/050/00399/AM15/ Party Name:KOPRAN ILIMITED Mect No/Date:1/82- IALC4/2015 115042015 Status: Dcffcrcd and Rc-indexcd 脇 棚 蒜 152/AMW辮 辮 憫Юη "yB忠 4m51 Dccision :lt was decided to defer the Pharmaccuticals. case for 14.06.2015 lor commcnts of Department Of Casc No.:32/5/82- ParサNamc:EMCURE PHARMACEUTlCALS LTD Status:Dcffcrcd and Rc-indcxcd IALC4/2014 Mcct No/Date:1/82- ALC4/2015 ]5042015 1198捻5餅0034ツAMlシ L鴇馴i90000vAM lyキ|ザZttα 3110063481:窮ち OЮ,2015 1 1Dccision:It、vas dccidcd to ca‖ from thc frm a copy of valid Drug ManuFacturing Licence fOr thc export product namely Fomepizole Injection l.5gm/ml vial indicating volume and composition of each vials ofcxport product. The case is deferred from 20.05.2015. Casc No.:15/5/82- ‐ Al,C4/2014 Pany Namc:PARA30LIC McctNo/Datc:1/82- DRUGS LTD, IALC4/2015 15042015 Statu s: Approvcd ´ ０ HQ Filc RLA Filc 10386135 Dctr Dac: :Ol'82/050/00332/AM15/ :05/24/040/00036/AN415/ 09052014 1)ccision : In the light of written comments received from Department of Pharmaceuticals vide ther OM No 35011/440/2014-PI(Norms)dated 06 02 2015′ t was dedded to ratify norms under Para 4 7 of HBP vl as per deta‖ s given below or as applied by the firm′ whicheveris less: Item of Export Qty SI No Item of lmport Quantity allowed kg/kg Ccfdinir l kg 7-Phcnylacetamido-3-Chloromethyl Ccphalosporanic Acid Para Mcthoxybenzyl Ester (GCLE) 2263 2 CAEM(S-2-Benothiazoly(Z)-2-(2- Amino Thi″ o14-y卜)‐ 2‐ Acctyioxyimino Thioacctate 1397 'friethvlamine 0377 4 n cctone 624 Methanol 655 6 Methylene Chloride 741 7 Activated Carbon 0055 8 'l'riphenylPhospine 1 234 N-Bu1yl Acetate 085 RA may take appropriate action as per the decision of Norms Committee. 瘍 li鸞] マFトロfヽT″ Deparlmcnt of Commerce u続聾轟謀誡 in
Casc No.:88/13/82- AI´ C4/2014 Pa“y Nalnc:MAITHRI Mcct No/Datc:1/82- Status:Dcrrcrcd LABORATORIES(P) ALC4/2015 and Rc― ind●、cd LTD, 15042015 101/82/050/01091/AN415/ :09/24/040/00061/AM15/ 12052014 Dなc:20052015 7 HQ Filc RLA Filc Lic No/Datc:09100600581)cft‐ r Dccision:It、vas dccidcd to dcfcrthe casc fOr 20 05 2015 for commcnts OfDcpartmcnt of Phannaccuticals ‐Casc No.:9/10/82‐ ‐Party Namc:EMCURE IMec・tNo/Datc:1/82- Status:Dcrrc・rcd lALC4/2014 1PHARMACEUTiCALS IALC4/2015 and Rc_indcxcd l lLTD 15 04 2015 HQ Filc RLA Filc Lic No/Date:3H0064004 Dctr :01/82/050/00923/AM15/ :31/83/040/00032/AM15/ 121 05 2014 Date:20052015 Dccision :It was decided to call from the firm a copy of valid Drug Manufacturing Licence for thc cxport product namely Fomepizole lnjection 1.5 gm/ml vial indicating volumc and composition ol' cach vial ofexport product. Casc No.:87/8/82- ALC4/2014 Party Namc:GLENMARK IGENERICS LIMITED Mcct No/Datc:1/82- IALC4/2015 115042015 Status: Approved HQ Filc RLA Filc ILic No/Datc:03107841 Dctr Datc: :O1/82/050/00751/AM15/ :03/94/040/001561ヽN415/ ‐77 03062014 1 Dccision:In thc lighl o「、vrittcn commcnts rcccivcd from Dcpartmcnt ofPhanllaccuticals vidc thcir 1 0M No 350H/448/2014‐ PI(Norms)dated Januaげ 2015,■was dccidcd tO rai″ thC nOrms undcr Para 4 7 ofHBP vl as pcrdcta‖ s givcn bclo、v or as applicd by thc irinn,、vhichcvcr is lcss: 9 ExOort Product:Cabapcntin Tabicts S No Import ltcm For Export of I No.Tablct 600nlE 800m■ 1 Gabapcntin 612.0 mg 8 I 6.0mg 2 Poloxamcr 407 75.0 mg 100.0 mg D Copovidone 600 mg 80.0 mg Paty Namc:HALDIA IMcct No/1)atc:1/82- PETROCHEMICALS IALC4/2015 LTD 10 HQ File IRLA Filc :01/82/050/00567/AM15/ :02/24/040/00037/AM15/ 105 06 2014 Dttc:20052015 11)ocision:Itwasdccidcdtodcfcrthecasefor20052015forcOmmcntsofDcpartmentoFC&PC (PC Division) Casc No.:165/6/82- ALC4/2014 Status: I)cl lcrcd and lle-indcxcrl 115042015 1Lic No/Datc:0210203844 DcFcr Party Name:BLISS GVS Meet No/Date:l/82- S ta tu s: I)cffcrcd ∩百o3",_′ , D蒲i評|| 鍮 11‐ ud凛編 ヽ ll Casc No.:85/9ノ82- “ : IヽOW Delhi
:01/82/050/00882/AM15/ 1:03/94/040/00178/AM15/ 126062014 Datc:20052015 I)ecision : It was dccided to cdefcr thc case for 20.05.2015 for comments of Department of Phamaccuticals. Department of umJ I ‐ ‐Casc No.:74/9/82_ Pa■y Namc:BLISS GVS IMcCt No/Datc:1/82- Status:Dcfrcrcd: ALC4/2014 1PHARMA LTD ‐ALC4/2015 and Rc― indcxcd i 115042015 12 HQ File lRLA Filc Lic No/Date:0310786144 Dcた r Ю1/82/050/00871/AM15/Ю 3/94Ю40/00277/AM15/ 27 06 2014 Date20 05 2015 ', lDecision : It was decided to defer the case for 20.05.2015 for comments ofDepartment of I ,Pharmaceuticals. I I | ICasc No.:248/13/82‐ Party Name:REANNON Meet No/Date:1/82- Status:DcFrcrcd l ALC4/2014 .PHARMACEUTICALS IALC4/2015 and Rc― indcxcd l 115042015 13 HQ F‖c RLA File Lic No/Datc:0310786993 Dcfcr l :01/82/050/01251/AM15/ :03/95/040/00325/AM15/ 17 07 2014 1Date:200520151 1Dccおion:■was dccidcd to dercrthe casc for 20 05 2015 for commcnts ofDcpartmcnt of l lPhanllaccuticals , ‐Casc No.:208ノ13ノ82- Pany Namc:IPCA ALC4/2014 LABORATORIES LIMITED Mcct No/Datc■/82‐ IALC4/2015 115042015 Status:Dcffcrcd and llc-indcxcd 141HQ Filc ltLA Filc Lic No/Dat 101/82/050/01211/AM15/ :03/94/040/00372/AM15/ 128072014 Dccision : It was dccidcd to deler the casc for 20.05.20I 5 for comments of Department of Phanraccuticals. Casc No.:209/13/82- Party Namc:AVA IMect No/Datc:1/82- Status:Dcrrcrcd ALC4/2014 CHEMICALS PVT LTD,ALC4/2015 and Rc― indcxcd HQ Filc ~~面 函Fi蔦 l15042015 Lic No/Date:0310787473 Dcrer :01182/050/01212/AMl5/ :03194/040/003'79/AMl5l 31.07.2014 Date:20.05.2015 Dccision :ln thc Iight of written commcnts rcceived lrom Petrochcmical Division of Dcpartmcnt of Chcrnicals and Petrochemicals vidc thcir OM No. 14010167/Z0l l-CH-ll dated 29.03.2015, it was dccidcd to call lrom the firm the following technical details: l5 i) Dctailed mzmufacturing process along with balanced chemical reaction indicating numbcr of moles ofall the reactions, products and by-products with concsponding molecular Formulae, structural formulae, molecular wcight and process flow diagram. ii) Stagc-wisc pcrcentagc yield wilh rcspect ofeach ofthe reactants and products and the rclevant justification enclosing therewith authentic printed technical literature in support ofyield or quantity of items for import. iii) Dctail of by-products formed during the process and their recovery value.
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11漱シ3/82_椰硫藻 |:書:嚢磐 1施 I昇商醜飩 Casc\o.:229l13/gZ- O"ry^r,n",Aiio ALC{/201{ r_rrirr,..^1.. ^il_. __ rvreer No/Dare:t/82_ c+_r..-.h .^ _. ぶ [Ш ・ _芯 I[:ド PV・ 『 臥 1シ麟∫ 岬 ム
濡 恐 聴 | :01 82050/01232/AMi5 :03/94/040/oo465 A〕 Dcc`bn:In thc light Or、vlttcn cOmmcnts recd、 卜晰圏鳳 l:哩l罵W総‖ !腎1:I:ュ ilDetailedmanufactui'cp:::':":-1',:':T:i:T:1-l':::::I"":"::::*-.:X5:' 蘇Wm砧響彎1?ヽ燎辮庶Ⅷ岨∬∞讐¨ :酬征 Tlll Ⅷu糠櫛こ垂需船翠滞撚群顆 搬#裂砕ギ難1淋1淋鶯1癬藷鷲躙l酬手糧il lや 麟 漁 纂脚 淵朧 艦鵬 稿 dll StlppOm電 'qurntitY ol items lor )rrrPU"'
ハ iii) Dctail of by-products formed during the proccss and thcir recovery in tcnns of quantity and value- iv) Details ofproduction ofexport product undcr rcfcrcncc and corrcsponding consumption ofraw material in the year 2013-14 and 2014-15 (April to October) duly ccrtificd by CA may be furnishcd. lf thc production has not commenced in the past, the details Irorn commcnccmcnt of production may bc furnishcd duly certified by CA. The case was deferred for 20.05.2015 Casc No.:227/13/82- Party Namc:CROWN Mcct No/Datc:1/82- Status:DcFcrrcd ALC4/2014 CHEMICALS PVT LTD,ALC4/2015 15042015 261。File ~ 良」Arlle~― ― ― tlciNo b滸き :“ lb788329 Dこ rc・r batc: :O1/82/050/01230/ノヽM15/ :03/94/040/00458//ヽヽ415/ 25082014 12062015 Dccision : [t was decided to deler the case for 12.06.2015 for comments of[)cpar(mcnt ofC&PC. Casc No.:228/13/82- ALC4/2014 27 HQ File Pa“y Narnc:CROWN CHEMICALS PVT LTD, RLA Filc Mcet No/Datc:1/82- ALC4/2015 15042015 Stalus: l)cferrcd Stalus: I)cffcrcd and Ilc-indcrcd Lic No/Datc:0310788328 Dcたr Datc: :01/82/050/01231//ヽ 1ヽ415/ :03/94/040/00456/AM15/ 25082014 12062015 Decision : tt was dccidcd to defcr the case for 12.06.2015 for commenls of Dcparttncnt of C&PC. Casc No.:215/13/82- ALC4/2014 HQ Filc ParサNamc:GOLD STAR McctNo/Datc:1/82- CHEMICALS PVT LTD ALC4/2015 15042015 RLA Filc Lic No/Datc:0310788338 Dcrc・ r :01/82/050/01218/AMi5/ :03/94/040/00358/AN415/ 25082014 1)atc:20052015 Dccision : [t was dccidcd to defcr the casc for 20.05.2015 for commcnts of [)cpartmcnt o I C&PC. Casc No.:45/13/82- ALC4/2014 29 HQ Filc Party Namc:HETERO Mcct No/Datc:1/82- DRUGS LIMITED, ALC4/2015 15042015 Lic No/Date:09100608851)crt・ r Status: l)cffcrcd and llc-indcrcd 1)atc:20052015 RLA Filc 101/82/050/01048/AM15/ :09/24/040/00275/Aヽ415/ 25082014 Dccision : It was decided to defer the case for 20.05.2015 for commenls ol Dcpartmcnt of Pharmaceuticals. Casc No.:46/13/82- ALC4/2014 30 HQ Fllc Party Namc:HETERO LABS LIMITED RLA F‖ c Mcct No/Datc:1/82‐ IAlンC4/2015 15042015 Sta tus: I)cl fcrcd and llc-indcxcd Lic No/Datc:0910060886 1)cibr :01/82/050/01049/ノヽN/115/ :09/24/040/00271/AN415/ 25082014 I)atc:20052015 Dccision : It was dccided to defer the case for 20.05.2015 lor commenls of Dcpartment of Pharmaceuticals. Partv Name:BAYEII Status: I)cffcrcd 雪ぶ D瑶野雪 紺鶴駐 Ｌ ヽ １ １ヽ ト R ■oF Commerce tよ『 gLlhi 31 Casc No.:264/13′ 82- ヽ4cct No/Datc:1/82‐
ヘ Al.C4/2014 CROPSCIENCE IALC4/2015 and Rc― indcxcd l LIN41TED ■5042015 1 ‖Q111c RLA F‖ c lLic No/Datc:0310788397‐ Dctr l :01/82/050/01267/AM15/103/94/040/00405ノAM15/'6 08 2014 Dac20 05 20151 1)ccヽ:on:Itwasdccidcdtodcrcrthccascfor20052015forcomllncntsofDcpartmcntOrC&PC I Casc No:2/7/82- Al.C4/2014 IALC4/2015 115042015 Status:Dcffcrcd and lle-indcxcd ― ; Party Namc:DR I{EDDYS Meet No/Datc: l/82- 32 HQ File l A30RATORIES ILIMITED 晨ラ(1誦ざ Lic No/Date:0910060892 DcFcr :01/82/050/00646/AMi5/ :09/24/040/00263/AM15/ 26082014 Datc:20052015 l)ccision : Il was decidcd to dcfcr lhc case for 20.05.201 5 for commcnts o f Dcpartmcnt ol Phamacculicals. C:lsc No.:255/13/82‐ AI′C4/2014 HQF‖ c 101/82/050/01258/AM15/ ILic No′つatc:0310788373 1Detr RLA Filc :03/95/040/00431/AM15/ 126082014 Dccision : It was decided to dcfer the casc for 20.05.2015 for comments of Dcparlmcnt ofC&PC. l Datc:200520151 Casc No.:43/9/82- Al.C4/2014 Party Namc:SARV BIO LA13S PVT I´ TD, ― : Meet No/Date:1/82- IALC4/2015 115042015 Slatus:Deffcrcd and llc-indcxcd HQ 1llC RLA Filc ‐Lic No/Datc10510390783 Deたr :01/82/050/00840//ヽM15/ :05/24/040/00203/Aヽ415/ .27082014 Datc:20052015 Dccision : It was dccide to call from the firm following information: i) Whcthcr thc export is Rescrpinc ofrclcvant pharmacopeia or Rcserpinc (+10%) as described in ANF 4l\ and Appcndix 33 ii) COA ofimport ilcm from Foreign supplier. The technical specification should spccifo the contcnt olRcscrpine in the import description l hc case is deferred for 20.05.2015. Casc No.:224/13/82- Al′C4/2014 t'arlyNamc:DELTA McctNo/Datc:l/82- Status:Dcffcrcd FINOCHEM PVT LTD :ALC4/2015 :1504.2015 and llc-indexed ‖Q1llc RLA Filc lLic No/Datc:0310788515 Dert・r i01/82/050/01227/AM15/ :03/94/040/00391/ンヽM15/ 128 08 2014 Date:20052015 Dccヽion:It was decided lo dcrc・rthc casc for 20 05 2015 for commcnts of Dcpartment of C&PC I Casc No.:225/13/82_ ALC4/2014 HQ F‖ e :01/82/050/01228//ヽM15/ I)alty Namc:DELTA FINOCHEM PVT LTD IMcct No/1)atc■/82- IALC4/2015 Status: Dcffcrcd and lle-indcxcd ゝ l)ccision : lt rvas dccidcd 1o dclcr thc casc lor 20.05.2015 Jbr comnrcnls ol l)cparlmcnt oiC&PC. 115042015 RLA Fnc lLic No Datc:0310788514 :03/94/040/00397/AM15/ 128082014 Deler Date:20.05.2015 Strtus:Dcffcrcd' and llc-indcxed '
Casc No.:256/13/82-
ALC4/2014
ParりNamelNAVIN
FLUORINE
INTERNAT10NAL
LIMITED
Mcct No/Datc:1/82‐
ALC4/2015
15042015
Status: l)cffcrcd
and Ilc-indcrcd
37
HQ File
RLA Filc
Lic No/Datc:0310788509 Dcrcr
:01/82/050/01259/AM15/ :03/95/040/00371/AM157 .28082014
Datc:20052015
Dccision : It was decided to defer the case for 20.05.2015 for comments of Dcpartment of C&PC.
38
Casc No.:257/13/82-
ALC4/2014
Paty Namc:NAVIN
FLUORINE
INTERNAT10NAL
LIMITED
‐Mcct No/Datc:1/82-
ALC4/2015
115042015
Status: I)cl ltred
rnd lLc-indcrcd
HQ Filc
RLA F‖ e
ILic No/Datc:0310788508 Dctr
:01/82/050/01260/AM15/ 103/95/040/00369/AM15/ 28 08 2014 Datc:20052015
Dccision:It was dccidcd to dcFcrthc casc for 20 05 2015 for cominlcnts of Dcpartmcnt o「C&I)C
CascNo.:254l13/82- PartyName:SEQUENT MeetNo/Date:1/82- Status:Dcffcrcd
ALC4l20l4
SCIENTIFIC LTD
ALC4l20l5
and Re-indcxcd
15.04.201 5
." HQ File
RLA File
Lic.No/Date:03 107885 13 Defer
:01182105O/01257 /AM l5/ :03/95/040/00459/AM l5/ 28.08.2014
Date:20.05.2015
Dccision : It was decidcd to defcr the case lor 20.05.2015 lor cotnments of Dcpanrncnt olC&PC.
Casc No.:262/13/82- Party Naine:ANTHEA Mcct No/Datc:1/82- Status:Dcrrc・
rcd
ALC4′2014 AROMATICS ALC4/2015 and Rc―
indcxcd
PVT LTD, 15042015
oo
t Iq Fil"
RLA Filc Lic No/Datc:0310788560 Dcた
r
101/82/050/01265/AM15/ :03/94/040/00971/AM14/ 101092014
Datc120 05 2015
Dccision:it、vas dccidcd to dcfcr thc casc for 20 05 2015 for coinillcnts or Dcpartmcnt o「C&I)C
Casc No.:263/13/82- Ptt Namc:ANTHEA Mcct No/Datc:1/82- Status:Dcrrcrcd
.ALC4/2014 1AROMATICS IALC4/2015 and Rc―indcxcd
PVT LTD,
■5042015
HQ Filc
RLA Filc
ILic No/Datc:0310788558 DcFcr
:01/82/050/01266/Aヽ415/ :03/94/040700962/AM14/ 01 09 2014 Datc120 05 2015
1)ccision: It、vas dccidcd to dcfcr thc casc for 20 05.2015 for comincnts oF Dcpaltincnt ofC&PC
‐
41
Casc No.:54/13/82‐
IALC4/2014
42,HQ Filc
Patt Namc:RA CHEM N4cct No/Datc:1/82- Status:Dcrrcrcd l
PHARMA LIMITED
‐ALC4/2015 and Rc― indcxcd l
115042015 1
RLA Flc Lic No/Datc10910060900 1DcFcr l
Datc:20052015
:01/82/050/01057/AM15/ :09/24ノ040′00272/AM15/ 101092014
Dccision : lt was decidcd to derer ttre case ioi i0.b5.2015 fo, "o,r-cnts
of Dcpartmcnt ol
Pharmaceuticals.
一
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43 Casc No.:63/13/82-
Stxtus: I)cl li'r'cd
Pa“y
晰鮮
Mcct No/1)atc:1/82-
ALC4/2014 1Namc:SATYADEVA IALC4/2015 and Rc‐
indcxcd l
PHARMACEUTICALS 15 04 2015 1
1 /P/LTD" | : |
|1 /P/LTD"
| IHQ File RLA File
l Ю1/82/050/01066/AM15/ :09/24/040/00268/A
I :DccisiOn:It was decidedtgここ
fcrthc case for 2
1 Pharmaccuticals.
‐Casc No.:217/13/82-
‐ALC4/2014
Decision : lt was decided to
Pharmaceulicals.
Palty Namc:ENCUBE Mcct No/Datc:1/82- Status:1)crrcrcd
ETHlCALS PVT LTD ALC4/2015 and Rc indcxcd
115.042015
44 HQ 1llc
RLA Filc
Lic No/Datc:0310788620 Dcfc・
r
:01/82/050/01220/Aヽ415/ :03/94/040/00494/AM15/ 102 09 2014 Datc120.05.2015
defcli16t基ざfOr,6:b:云5「ζ fOr t品島ι
ntζ OfDepanふ6ntOF I
Casc No.:223/13/82‐ Party Namc:KRISHNA Mec・tNo/Datc:1/82‐ Status:DcrScrcd,
‐ALC4/2014 ANTIOXIDANTS PVT ALC4/2015 and ltc―
indcxcd l
LTD 15 04 2015 1
45 nQ Filさ ~ ~ RLAriざ
~―
― Lic No/Datc:0310788647 Dcfer i
l :01/82/050/01226/AM15/1:03,4/040/00508/AM15/102 09 2014 Date:20052015i
l Dcd●on:It was dcddcd lo detrthc casc for 2,9,′ 91'やrc9mT,1'♀lP"攣T,11ヴ9些:9:|
Casc No.:259/13/82_ Party :Mect No/DateJ/82- IStatus:DcfFcrcd l
‐ALC4/2014 Namc:DANOPHARM IALC4/2015 and Rc‐
indcxcd i
'CHEヽ41CALS PRIVATE ■5042015 1 1
46. LTD
‐ HQ Fne RLA Fnc Lic No/Date:03 10788693 1Dcrcr l
:01/82/050/01262/AM15/ :03/94/040/00370/AM15/ 103092014 1)atc:200520151
‐ ‐Dccision:It was dccidcd lo deferthc casc fOr 20 05 2015 for commcnts ofDepartmcnt orC&PC I
| IDccislon:ln the nght Of wntten cOmments received from Department of ChemicaL and
‐
Petrochemicals vide their U O No 14010/64/2013‐ Ch H dated 15 04 2015′ lt was decided to
471『|よょよ:∬
er Para 4 7 of HBP vl as per detaik」ven below or as ap口た
d by the irm′
Export product
Exp
Qty
SI No
lm port items
Qty. allowed
STEROSOL ACT(BP2)
(BlendS OfIヽpcr″inc&
lヽ
`cthyl Di Ethanol
Aminc)
l kg
MONO METHYL AMINE
0 1144 kg
ETHYLENE OXIDE
0 3240 kg
3
PIPERAZINE 68%
0 1500 Кg
―
―
―
繰
ゴ
｀4AL Kυ MAR
I蕊翼iilll=ギ壁
徊
禽憚
Casc No.:251/13/82_
ALC4/2014
IPany NamciSTERLING IMect No/Datc:1/82-
IAUXlLIARIES PVT ,ALC4/2015
LTD 15 04 2015
Status:
Approvcd
RA may take appropriate action as per the decision of Norms Committee.. ICasc No.:253/13/82- PなりNamc:STERLING IMcct No/Datc:1/82‐ Status: ‐ALC4/2014 1AUXILIARIES PVT IALC4/2015 Approvcd LTD 15 04 2015 ‐HQ Filc RLA Filc Lic No/Datc:0310788657 Dclcr Datc: :01/82/050/01256/AM15/ 10395/040/00462/AM15/ 103092014 1Dccision :n the ight of written comments received from Department Of Chemicals and Petrochemicals vide their u o No 14010/64/2013‐ Ch ll dated 15 04 2015′ it was decided to lratify norms under Para 4 7 of HBP vl as per detaiに given below or as appled by the trm′ 48 WhiCheveris less: Export product Exp Qty SI No lm port items Qty. allowed Stcro PEA(Poly Ethoxylatcd Mcthyl Aminc) l kg MONO METHYL AMINE 0 1940 kg 2 ETHYLENE OXII)E 0 8260 kg Casc No.:84/13/82- ParりNamc:EMCURE Mcct No/Datc:1/82‐ Status: ALC4/2014 PHARMACEUTICALS ALC4/2015 Approvcd LTD 15 04 2015 1HQ Filc lRLA Filc llc No/Datc:3110064857 Dcた「 101/82/050/01087/AIヽ415/ 131/83/040/001321ヽM15ノ 105092014 1)atc: IDccision :In thc light of writtcn cOmmcnts rcccivcd froln Dcpallincnt o「 Pharitnaccuticals vidc thcir OM No 350H/537/2014-PI(Norms)datcd 07 04 2015,lw¨ dccidcd to rai″ thc nOnns undcr Para 4 7 o「IIBP vl as pcr dctans given bclo、v or as applicd by thc irm,whichcvcr is lcss::‐ 149 Export product Export Qty. SI No Import items Qty.a110WCd (kg/kg) ATAZANAVHく SULFATE l kg 1 EPOXIDE CHEMICAL 049 つ ‘ T―BOC HYDRAZINE 050 N―METHOXYCAR30NYL‐ I´ ‐ TERT LEUCINE 077 4 EDAC― HCL l― (3- DIMETHYLAMINOPROPYL)‐ 3‐ETHYLCARBODHMIDE HYDROCHLORIDE 079 takc action as thc dccision of Norms Committce. may takc appropriate action as per 50 Casc No:234/13/82- :Party Naillc:KUSUMA Mcct No/Datc:1/82- Status: 肛 猾 :鶯 饉 黒拙Te
:ALC4/2014 lIQ FHc 101/82/050/01237/AM 15/ IDccision:in the light of wntten cOmments received from Department of Chemicak and Petrochemicaにvide their U O No 14010/32/2013-Ch‖ dated 15 04 2015,t was dedded to lraJfv nOrms under Para 4 7 of HBP vl as per deta‖ s given below or as applied by the irm′ ヽvhichever is less: Export product Exp Qty SI No lmport items Qty. allowed SODIUM SACCHARIN(PURE DENTAL GRADE) l kg 1 SODlUM SACCHARIN 1 02 kg '責 A- lAL04/2015 ■pproVCd i l15 04 2015 1 Pa町 IMeet No/Data 1/82- INamc:MANGALAM IALC4/2015 10RGANICS LIMITED 15 04 2015 KFORMERLY I IDUJODIVALA I Slatus:Deffercd Casc No.:22/13/82- ALC4/2014 1521 IHQ F‖ c 101/82/050/01025/AM15/ RLA File Lic No/Date:0310788810:Dcfer Ю3/95/040/00379AM15/b5092014 Date:20052015 l)ccision: It was dccidcd to defcr the case lor 20.05.2015 for commeflts of Department ofC&PC. ‐ 一 一 Casc No:196/13/82_ ALC4/2014 53,HQ File PartD Namc:KOPRAN LIMITED RLA Filc :03/94/040/00545/AM15/ Mect No/Date:1/82- ‐ALC4/2015 ‐15042015 Status:Dcffercd and Rc-indcxcd ,Lic No/Date:0310788934 109092014 IDefer IDate:20052015 :01/82/050/01199/AM15/ Dccision : lt was decided to defer the case for 20.05.2015 for comments of Department of Pharmaceuticals. Casc No.:201/13/82- iParty Name:KRISHNA ,Mect No/Datc: t/82- Status: Dcffcrcd ALC4l20l4 ;ANTIOXIDANTS PVT. ALC4|2015 and Rc-indexcd l iLTD. l s.o4.2o l s . /,-- ItQ File RLA file Lic.No/Date:0310788928 Defer l :011821050/012041AM15/ ::03/94/040/004991AM15/ 09.09.2014 Date:20.05.2015l Dccision : lt was decidcd to dcfcr lhe casc for 20.05.2015 for commenls of DepaflmdfE&Pc. 軸 1lζ |=Tq ,,Trade nDe:hi ICasc No.:235/13/82- IALC4/2014 rany NamoKUSUⅣ晨 PWゝb4A 51責。● iさ :RLA Πに :01/82/050/01238/AM15/ :03/94/040/005007AM15/ I)ccision:lt was decided to deferthe case for 20 05 2015 for comments ofDepartment ofC&PC I
Casc No.:26/13/82- ALC4/2014 Party Name:STERLING ‐AUXILIARIES PVT LTD IMeet No/Date:1/82- IALC4/2015 115042015 Status: Approvcd Filc :01782/050/01029/AM15/ RLA Flc :0395/040/00493/AM15/ ILic No/Datc:0310788939 1Dcrcr 09092014 ‐ Datc: Petrochemicals vide their U.O No. ratify norms under Para 4.7 of HBP whichever is less: IDccision :In thc light of wdttcn commcnts rcccived from Dcpartmcnt of Chcmicals and 14010/64/2013‐ Ch II datcd 15 04 2015, it ヽvas dccidcd to ' v l as pcr dctails givcn bolo、v or as applicd by thc flrill. 晒 l.Export ltem Qty SL N lmport Product Quanity STERO DIPA 85 (Dilsopropanolaminc) l kg 1 D‖ SOPROPANOLAMINE (DIPA 99) 0 925 kg | 2.Export ltem l kg 1 NONYL PHENOL 0 204 kg STERO NC 200(NonyI Phcnol Polyglycol Ethcr) 2 ETHYLENE OXIDE 0 816 kg 3.Export ltem l kg 1 ETHYLENE OXIDE 0 8900 kg STERO TEA(MX) (T●CthanOlallninc Mixturc) 2 MONO METHYL AMINE 0 0427 kg 4. Export ltem l kg LAURYL ALCOHOL 0 478 kg STEROL 1205(Lauryl Alcoho1 3 molc Ethoxylatc) ETHYLENE OXIDE 0 542 kg 5. Export ltem l kg 1 NONYL PHENOL 0 4857 kg STERO NC 080(NonyI Phcno15 5 molc Ethoxylatcd) 2 ETHYLENE OXIDE 0 5343 kg 6. Export ltem l kg 1 ISO TRI DECANOL (ITDA) 0 3423 kg STEROL 1312 (Iso TH Dccano1 9 molcs Ethoxylatcdllso Tri Dccyl AIcohol Ethoxylatc) 2 E「HYl.ENE OXIDE 0 6777 kg take aDDropriate action as Per the decision of Norms Committcc. 又 de qrFlq ffirvl ,ぃ暉VElepanmcnt oi COTrnerce L魚誡 IⅢ appropriate 凛愈Ъ凛顧LF
Casc No.:27/13ノ82- Party Namc:STERLING IMcct No/Datc:1/82- status:Approvcdl
A:′C4/2014 1AUXILIARIES PVT ALC4/2015
Lη｀1) 15042015
HQF‖ c RLA Filc Lic No/Datc:03 10788943 1DcFcr Date: |
| :01/82/050/O1030/ノヽヽ415/1:03/95/040/00494/AM15/109092014 1 :
I)ccision :ln the lighl of written comments received from Depanment of Chcmicals and
Pctrochemicals vidc their U.O No. 14010/64 /20'13-Ch. ll dated 15.04.2015, it was dccidcd to
ratify norms undcr Para 4.7 of HBI, v I as per dctails given below or as applied by the firm,
whichevcr is less:
l.Export ltem
Qty
SI N
lmport Product
Quanity
STER PEG 400(Polycthylcne Glycol
400)
l kg
1
DI ETHYLENE
GLYCOL
0 261l kg
2
ETHYLENE OXIDE
0 7589 kg
2.Export ltem
l kg
1
DI ETHYLENE
CLYCOL
0 0469 kg
STER PEG 4000(POlycthylcne
Clyco1 4000)
2
ETHYLENE OXIDE
0 9731 kg
IIA may take appropriate action as per the decision ofNorms Conrmittee..
Casc No.:23/13/82_ Party Namc:YASHO Mcct No/Date:1/82‐
status:Dcfrcrcd‐
ALC4/2014 1NDUSTRIES PVT LTD IALC4/2015 and Rc―
indcxcd
115042015
57 HQ Filc RLA Filc tic N″
Datc103107889 H Dきたr
Ю1/82/050/01026/AM15/Ю 3/95/040/00496ハM15/ρ909 2014 Dac20.o5.2015
V,′ ψ‐lv´ υ′0■υ4V′ ハ■,11′ ′ lυ 」′フυ′V"υ ′VV十フ0′ ′ヽlVII D′ :υ ソυソZυ 14 1DatC:zυ
.oO.2015,
一―― ― ―――― ―――■―,「三~~■~r― ■―― ―=~~~~―
‐――――_____―
―ヽ一―――- 1
DccisiOn:It was dccided to defer thc case for 20 05.2015 for comments of Dcpartmcnt Ofc&Pc I
CascNo.:250/13/82- PartyNamc:YASIIO MectNo/Datc:l/g2- Starus:Dcffcrcd,
ALC4l20l4
.INDUSTI{IES PVT.LTD. ALC4/2O]rS
and llc_indcxcd i
5r{
15.04.20 t5
'" I lQ Filc
RLn Filc
Lic.No,Datc:0i 10788892 Defer
:0]/821050101253/AMts/ :03r95/0i0t00490/AMr5/ 0rJd;0r4
Dare:20.05.20r5
l)cciskrn : It was decidcd to defer thc case for 20.05.201 5 for comments of Depanment of c&l)c.
15042015
59‖ Q Filc RI´ A FHc ‐Lic No/Datc:0910060924 Detr
Ю1/82/050/01065AM i5/ Ю9/24Ю40/00257れMi5/10092014 D籠
o200520151
1)ocision:ltwasdccidcdtodcfcrthccascfOr20052015forcOmmcntsOfDcpartmentOf l
I)harmaccuticals
Casc No.:62/13/82-
AI′C4/2014
Casc No.:71/13/82-
AlッC4/2014
Parly Namc:EYTAN
LABS LIMITED
Party Nanlc:INCHEM
I´ABORATORIES
PRIVATE LIMITED
IMcet No/Date:1/82‐
lALC4/2015
Mcct No Datc:1/82-
ALC4/2015
15042015
Status: Deffcrcd
and llc-indcrcd
Status: Dcffcrcd
and llc-indcxcd
HQ Filc RLA FHc Lic No/Datc109100609ol pctr
‐
:O1/82′050/01074/AM15/ :09/24/040/00313/AM15/ 10092014 ,Date120 05 2015
輻
:轟Delhi
60
I)ccision : Ir was dcc idcd ro defer the casc lor 20.05.20 I 5
Pharmaceuticals.
for commcnts of Dcpartmcnt of
161
Casc No.:53/13/82-
ALC4/2014
1HQ Filc
PaロッNamoMYLAN
LABORATORIES
LIMITED
Mcct No/Datc:1/82-
ALC4/2015
115042015
Status:Deffcrcd
and llc-indcxcd
RLA Filc lLic No/Dttc:0910060930 Dcfcr
:01/82/050/01056/ノヽM15/ :09/24/040/00240/AM 15/
■0092014
Datc:20052015
Dccision : It was decided to defer the case for 20.05.20 [ 5 for comments of Dcpartmcnt of
Pharmaceuticals.
ICasc No.:64/13/82-
ALC4/2014
Pary Namc:MYLAN
LABORATORIES
LIMITED
IALC4/2015
115042015
Status: Dcffcrctl
antl llc-indcxcd
62 HQ Filc
RLA Filc
Lic No/Datc:0910060929 Dcfcr
:01/82/050/01067/AM15/ :09/24/040/00247ノAM15/ 10092014
Datc:20052015
Decision : It was decided to defer lhe case for 20.05.2015 for comments of Department of
Pharmaceuticals.
Mcct No/Datc:1/82-
ALC4/2015
15042015
IHQ Filc RLA Fnc lLic No/Datc:0910060941 Dcrcr
101/82/050/01069/AN415/ :09/24/040/00303/AM15/ 11 09 2014 Datc:20052015
Dccision:It was dccidcd to detr thc casc fOr 20 05 2015 for cOinnincnts or Dcpartincnt of
Phannaccuticals
´
０
64
Casc No.:66/13/82-
ALC4/2014
Party Namc:DIVIS
LABORATORIES LTD,
Strtus:Deffcrcd
and llc-indcxcd
Casc No.:69/13/82-
ALC4/2014
Paty Namc:DIVIS Mcct No/Datc:1/82- Status:Dcfrcrcd
‐LABORATORIES LTD, ALC4ノ2015
and llc-indcxcd
‐15042015
HQ Filc RLA Filc Lic No/Datc:0910060942 Dctr
:01/82/050/01072/AM15/ 109/24/040/00302/AM15/
■1 09 2014 Datc:20052015
Dccision : It was dccidcd to defer the case for 20.05.201 5 for commcnts ol Dcpartment of
Phannaceuticals.
Casc No.:85/13/82-
AI´ C4/20:4
Party Nainc:EMCURE
PHARMACEUTICALS
LTD
Mcct No/Datc:1/82- Status:
ALC4つ015 1Approvcd
15042015
I HQ Filc RLA Filc Lic No/Datc:3H0064875 Dctr
1 101/82/050/01088/AM15/ :31/83/040/00137/AM15/ H092014
‐
Datc:
`5 Dccision:In thc light of writen commcnts rcccivcd froin Department of Pharmaccuticals vidc
1 lhClr oM No 35011/537/2014-PI(Norms)datcd 07 04 2015,it was dccidcd to rati～
thC nOnms
l undCr Para 4 7 ofHBP vl as pcr dctails givcn bclow or¨
applicd by thc nrm,whichcvcr is lcss:■
||
Export product
Export
Qty.
SI No
Import itcms
Qty a110WCd
(kykg)
|ゝ
ff<
gtqrY
O!. Oirector G,
器謂鶴お蹴篤[=毬織
udy。聾置L「議勝乱lロ
ATAZANAVIR SUI′ FATE l kg 1 EPOXIDE CHEMICAL 049 2 T―BOC HYDRAZINE 050 D N―METHOXYCARBONYL‐ L‐ TERT LEUCINE 077 4 EDAC‐HCL l― (3- DIMETIIYLAMINOPROPYし) 3‐ETHYLCARBODHMIDE HYDROCHLORIDE 079 thc of Norms Committec. Rn may take appropriale aclion as per Casc No.:197/13/82- Al′C4/2014 I)arty Namc:KOPRAN LIMITED Mcct No/Date:1/82- Status:Dcrrcrcd and lle-indcxcd IALC4/2015 115042015 66 HQ Filc RLA File Lic No/Date:0310789054 Defer :O1/82/050/01200/′ ヽヽ415/ :03/94/040/00547/Aヽ415/ 11092014 Datc:20052015 Dccision : It was dccidcd to defer the casc for 20.05.2015 for comments of Department of Phanraccuticals. Casc No.:72/13/82- Patt Namc:SRIAN4 Mcct No Datc:1/82- Status:Dcrrcrcd ALC4/2014 LABS PRIVATE ALC4/2015 and ltc― indcxcd LIMITED 1 5 04 2015 HQ 1llc RLA Filc Lic No/Datc:0910060939 Dctr :O1/82/050/01075/Aヽ415/ :09/24/040/00287//ヽヽ415/ 11 09 2014 Datc:20052015 Dccision : lt was decidcd to defer the case for 20.05.2015 for commcnts of Department of Pharmaceuticals. Casc No:68/13/82- IPa■y lヽ4cct No/Date:1/82‐ IStatus:Approvcd Al,C4/2014 1Narnc:AUROBINDO IALC4/2015 1 PHARMA LIMITED 115 04 2015 1 HQ lllc RLA Filc Lic No/Datc:0910060958‐ Defer Date: :O1/82/050/01071/AN415/ :09/24/040/00296/AM15/ 12092014 1)ccision : In thc light of writen commcnts rcccived from Dcpartmcnt of Pharmaceuticals vidc thcir OM No 350Hノ597/2014‐ PI(Norms)datcd 29 04 2015 2015,it was dccidcd to ratitt nOrms ‐undcrI)ara47oFIIBPvl asperdcta‖ s givcn bclow or as applicd by thc rlrm,、vhichever is iess: 167 Item of Export Quantity S No Item of lmport Quantity a‖owed kg/kg rlNASTERIDl: l kg 1 2,3-Dichloro-5,6-dicyano-1,4- benzoquinone 086 2 4-Dimcthyl Aminopyridine 100 3 Azaandrostanccarboxam ide (Androsr4-Aza-3-One-1TBeta-N-, r' . 17647 糀 :嶽ぶ墓^鵬 in
4
BiS(Trimcthylsilyl)t‖ nuOroacctamidc
(BSTFA)
147
5
Activated Carbon
0012
6
Methanol
466
7
Methylcnc chloride
750
8
Tctrahvrlroluran
300
9
Toluene
484
10
Trifl uoromethane sulfonic acid
0004
ICasc No.:65/13/82-
ParりNar
LABORA
Casc No.:65/13/82- IParりNamαMSN I Mcct No/Datc:1/82-
Status:Dcffcrcd
and llc-indcxcd
IALC4/2014
TORIES
IALC4/2015
115,042015
PRIVATE LIMlTED
691HQ Fnc lRLA File Lic No/Datc:0910060955‐
Dctr
101/82/050/01068/AM15/ 109/24/040/002837Aヽ415/ 112092014 ‐Datc:20052015
Decision : it was'decided'io defer the case for 20.05.2015 for comments of Dcpanrncnt o f
Pharmaceuticals.
| ICasc No.:70/13/82- Paty Namc:SUVEN IMect No′
Datc:1/82- Status:Dcfrcrcd l
l lALC4/2014 1LIFE SCIENCES IALC4/2015 and Rc indcxcdl
l l lLIMITED 115 04 2015
‐
7●HQ Filc lRLA Filc Lic No/Datc:0910060954 1Dclt・
r
‐
| :01/82/050/01073/AM15/ 109ノ24/040/00310/AM15/ 12 09 2014 1Datc:200520151
1 1Dccision:It was dccided to dcfcrthc casc for 20 05 2015 for commcnts ofDcparlincnt of
‐
| IPha111laccuticals
l lCascNo.:25/13/82- ParッNamc:TITAN IMcct No/Datc:1/82- Status:Dcrfcrcd i
l lALC4/2014 1LABORATORIES PVT IALC4/2015 and Rc―
indcxcd l
l l lLTD 15 04 2015 1 1
721HQ Filc RLA Filc lLic No/Dttc:0310789100 1Dcfcr
l lЮ 1/82/050/01028/AM15/Ю 3795/040/00465ムM15/12 09 2014 1Datc20 05 2015
1 1)ocision:It wおdccidcd to dcfcrthc case for 20 05 2015 for cOmments or Dcpartincnt of l
l lPharmaccuticals
ParりName:TITAN IMect No/Datcl1/82‐
ILA30RATORIES PVT IALC4/2015
1LTD 15 04 2015
| ICasc No.:28/13/82-
| IALC4/2014
Status: I)cl lcrcd
and llc-indcrcd
1731
IDcfcr
阻
蜃
魃
、
ミ劇T
HQ Filc
ItLA Filc
ILic No/Datc10310789099
| ICasc No.:61ノ13/82- Pary Namc:SHODHANA IMcct No/Date:1/82- Status:Dcrlcrcd
l lALC4/2014 LABORATORIES LTD IALC4/2015 and Rc―
indcxcd
115042015 1
701HQ Filc RLA F‖ c Lic No/Datc:0910060952 1Dcfcr
101/82/050/01064/AM15/109/24/040/00291/AM15/12092014
IDatc:20052015
was decided to defer the case for 20.05.2015 for comments of Departmcnt of
biた2/036んibbi′ÅM15'b3/95/040/003す意/AM15/貶扇函面 Datc:20052015 I)ccis ion : It was dccided to dcfcr the case for 20.05.201 5 for comments of Depafimcnt o f Phanracculicals. 」 Casc No.:39/13/82- Al′C4/2014 ~¬ 研面悪函預N Med No/Dac1/82~再 而而crcrcdl LABS LIMITED ALC4/2015 15042015 :and Rc‐indcx●d 74 HQ F‖ e RLA File ‐ Lic No′1)ate:0910060979 Derer :01/82/050/01042/7｀M15/ :09/24/040/00270/AM15/ 16092014 IDate:20052015 Dccision : It was dccidcd to defer the case for 20.05.2015 for comments ofDepartment of Phannaceuticals 」 Casc No.:188/13/82- ALC4/2014 75 HQI、 lc Pany Namc:DELTA ,Mcct No/D・ate:1/82- FINOCHEM PVT LTD IALC4/2015 115042015 RI´A Filc Status: Dcffcrcd and llc-indexed | ILic No′Date:0310789322 1Defer 102/AM15/ 117 09 2014 1Date:20052015 :O1/82/050/01191/ノ｀M15/ :03/94/040/00 I)ccision : It was dccided 10 dcfcr lhc case for 20.05.2015 for commcnts of Dcpartmcnt of C&PC. Casc No.:101/13/82- Pany Namc:RELIANCE Meet No/Date:1/82- Status: AI´C4/2014 1NDUSTRIES LTD IALC4/2015 1Approvcd 115042015 1 HQ Filc RLA Filc tic No/Date10310789416‐ Dercr :01/82/050/01104/′ ヽM15/ 103/95/040/004061NM 15/ 18 09 2014 Date:200520151 1)●cision:ln the light of written comments received from Petrochemical Division of Department of Chemica s and Petrochemica s vide their U O No 46011/98/2006-PC― ‖dated 23 03 2015,it‐ %篇蒲 1常li鯉RWSm“ rPara 47 d H絆4¨ "r dettts」 wn晩る W¨ "p ed" Export product Exp Qty SI No Import items Qty Allowcd MT Para Diethyl llcnzcnc (PDEB) lMT 1 Naphtha 12567 Casc No.:18/13/82_ A【ンC4/2014 77 HQ「 ilc Party Namc:BEST Mcct No/Date:1/82- Slatus: Dcffcrcd and Ilc-indexcd VALUE CHEM PVT IALC4/2015 1´TD 15 04 2015 ― | :O1/82/050/01021/AM15/ :34/24/040/00152/AM15/ ■9092014 ‐Datc:20052015 ii".iri"rilt "s a..ilAi" d"f th";" f"r 20.05201if".;"-il;. "f D"pat..rt oiC -i Casc No.:57/13/82- 78 AI´ C4/2014 Party Name:HELLO PAINTS(P)1.TD llN4eet No/Datc:1/82- IALC4/2015 15042015 IW 4AL КuMAR l i 可fT I〕ヽl・3de '‐ 0 ノI Trude nt o`Cornmerce R軸:Ы
⌒ : It was decided to defer the case for 20.05.2015 for comments of Dcpartmcnt ofC&PC. No.:59/13ノ82_ Nallnc:HELL0 Mcct No/Datc:1/82‐ 14 AI■lTS(P)LTD ALC4/2015 Ilc-indcrcd 15042015 052015 Decision : It was decided to dcfcr the case for 20.05.2015 for comments of Dcpartmcnr o f Casc No.:249ノ13/82- Party Name:YASHO ALC4/2014 1NDUSTRIES PVT LTD 8011。118 ■RLAnic 10789471 1/82/050/01252/AM15/ 18/AM15/ 19092014 : [t was dccided to defer the case for 20.05.2015 for comments of Department of C&PC. 15042015 No.:75/13/82‐ ` Nalnc:DHANUKA TORIES LTD Mcct No/Datc:1/82‐ IALC4/2015 115042015 and llc-indcxcd Namc:GMSIM No/Datc:1/82- Stntus: l)cflcrcd and lic-indcxed LTD, 15042015 : lt was decidcd to dclcr the case for 20.05.2015 for comments of Department of C&pC. No:115/13/82- Namc:WEST NO/Datcl1/82- 11 CHEMICAL LIMITED 15 04 2015 Filc 1/82/050/O1118/AM15/ :It、vasdccidcdtOdcrcrthccascfOr20052015 forcommcntsOfDcparlincntOfc&Pc L■鵡誌め龍面 蔽 辮 油般~淵 柱摯需 ENTERPRISES IALC PVT LTD 150` ユ19_ IRLA「 “ ` 1/82/050/olo777AM 15/ 'AMts/ .24.09.20t4 10391308 Deter .1.VA,ZV I + : tt was dccided lo deler [he case fc . :.--: :l_. ?-0.0:.2qt 5 for commenb or r"r._:H:?:r#, fft{ grqr<I rurnvau xut,l, gq e<rFrl,r.r, iilyr =-- Ot: Djrodrr C I'r.,rt ,{ I . " -,. r;: ftq arr r ,, t, ,'- -'- Dt€ctor.rre G" ,",., ,. I ",. ,,', i,; QIFIf,I l+$.r/orern",ent or c:,m-, u,ffinTf,S,ffi, 1/82′050/01078/AM15/ : AIヽ415/ 23092014 : [t was decided to defer the case for 20.05.2015 for comments of Department of 82 1riO 111ぎ｀ 良Lズr"ざ― ――― |しic No/Datc:3410040570 101/82/050/01020/AN415/ 134/24/040/00155/AM15/ 123092014 I).lrcrcd |へM15/ 23092014 Cnsc No.:74/13/82- Al.C4/2014 HQ File RLA Filc Lic No/Datc10510391246 Dcfcr 101/82/050/01060/AM15/ :05/23/040/00277/AM15/ 119 09 2014 Datc120 05 2015 Al.C4/2014
No.:192/13/82_ 14 Iζ c―indcxcd RLA F‖ c :01/82/050/01195/AM15/ :03/94/040/00539/AM15/ 124092014 : It was dccidcd to defer the case for 20.05.2015 lor commcnts of Department of C&PC. No.:148/13/82- Nainc:MICRO Mcet No/Date:1/82- 14 LTD ALC4/2015 15042015 Rc-indcxcd : It was dccidcd to dcfcr the case for 20.05.2015 for commenls ofDcpartment of Casc No.:30/13/tl2- Parly Name:R L FINE ALC4/2014 Ilc-indcrcd Meet No/Datc:1/82- IALC4/2015 15042015 Filc RLA File :01/82/050/01033/Aヽ415/ :07/24/040/00218/AM15/ : It rvas decided to dcfer the casc for 20.05.2015 for commcnts ofDepartmcnt of :lt rvas dccidcd to rcjcct the casc as the firm has not fumishcd infonnation despite rcminders. 89 Casc No.:158/13/82- ALC4/2014 l'ilc casc No.:159/13/82- AIフC4′2014 Party Name:BDR PIIARMACEUTICALS INTERNATIONAL PVT ILTD 1/82/050/01 :It、vas dcCided to F‖ c 161/′ヽM15/ :03ノ94/040/00522/ the case for Of Depamment Of 應 υ 一 ｒ Ｄ つ ‘ 一 １ １ 一 〇 夕 一 ” Ｍ ‐ 一 ∞ Ａ 一 ２ No/Datc:1/82‐ llc-indcxcd NoノDate:1/82- 1504.2015 Lic No′1)atc:0310789636 No/Datc:1/82- 15 15042015 ilgzlosoto t t ezlruta t sl INTERNATIONAL PVT. 15042015 Ilc-indcrcd Patt Namc:INDOFIL INDUSTRIES LTD 861HQ Filc RLA File :01/82/050/01151/AM15/ :07/24/040/00208/AM15/ 24092014 IDatc:20052015 Datc:20052015 Casc No.:47/13/82- Al.C4/2014 PartyName:ALCI'lEM MeetNo/Date:l/82- Status: INTERNAT10NAL LTD ALC4/2015 llcicctcrl
l)ccision : It rvas dccided to defcr the case for 20.05.201 5 for commcnts of Dcparlmcnt of ['harmaceuticals. 191 Casc No.:20/13/82- ALC4/2014 HQ Fnc Party Namc:PROLIFE lNDUSTRIES LIMITED RLA Filc Mcet No/1)atc:1/82- ALC4/2015 15042015 Status:Deffcrcd and Rc-indcxcd Lic No/Datc:0810133449 Dclcr :01/82/050/01023/AM15/ 108/24/040/00124/AM15/ 125092014 Datc120 05 2015 I)ccislon:It was dccidcd to dcrcrthc casc ror 20 05 2015 for commcnts of Dcpartincnt ofC&I)C Casc No.:21/13/82‐ ALC4/2014 Party Name:JUBILANT GENERICS LTD Mcct No/1)atc:1/82- Sta tu s: I)cffc rcd and llc-indcrctl ALC4/2015 15042015 92 HQ File RLA Filc Lic No/Datc:0510391357 Dcrcr . :O1/82/050/01024/ノヽM15/ :05/23/040/00260/AM15/ 126092014 1)atc:20052015 1)ccision:lt was dccidcd to dcrcrthc casc for 20 05 2015 for conlmcnts of Dcpartinlcnl of I)harmaccuticals. Casc No:50/13/82‐ ALC4/2014 Pa“y Namc:PAYAL Mcct No/Datc:1/82- Status:Dcrrt・rcd PETROCHEM PRIVATE ALC4/2015 and Rc― indcxcd LIN41「ED 15042015 93 HQ Filc RLA I■lc Lic NolDatc:05103913681)cltr : Casc No.:51/13′ 82- ALC4/2014 :01/82/050/01053/AM15/ :05/24/040/00211/AM15/ 26092014 I)atc:20052015 Dccision : It was dccided to dcfcr thc case for 20.05.201 5 for cornmcnts of Dcpartmcnt of C&PC. PartyName:PAYAL MectNo/Datc:l/82- Status:Dcffcrcd IPETROCHEM PRIVATE:ALC4/2015 and Rc― indc、cd LIN41TED 15042015 IHQ F‖ c lRLA Filc lLic No/Datc:05103913671)crc・r 101/82/050/01054/AM15/ :05/24/040/00444/AN414/ 126092014 1)atc:20052015 1)ccision:It、vasdccidcdtodcrcrthccascfor20052015forcomincntsofDcpanincntoFC&I)C 194 I Casc No.:52/13/82- | ‐ALC4/2014 95 HQ「 ilc Party Name:PAYAL IMcct No/Datc:1/82‐ Strr t us: I)cl li'rc(l rund llc-indcrcrl PETROCHEM PRIVATE IALC4/2015 LIMITED 15 04 2015 RLA Filc Lic No/Datc:0510391369 1)cncr :01/82/050/01055/AM15ノ :05/24/040/00231/Aヽ415/ 126092014 I)atc120 05 2015 l)ccision : lt was dccided to dclcr the case for 20.05.201 5 for comrncnts of Departmcnt of C&l'C Mcct No/Datc:1/82‐ Casc No.:49/13/82- ALC4/2014 Party Name:SENTISS PHARMA PVT LTD Str tus: l)cl lcrc(l and llc-indcrcd IALC4/2015 115042015 ,6 HQ File RLA Filc Lic No/Datc:05103913891)crcr :O1/82/050/01052/Alヽ415/ :05/24/040/00284/AN415/ 126092014 1)atc:20052015 6""1.tr, , Itffi052015 f". "",r.trtt oioepa.t."nt ot Pharmaceuticals. h
ICasc No.:19/13/82- Par,Namc:SANO IMcct No/Datc:1/82- Status:Dcrrcrcd l
l ‐
Al′C4/2014 MEDICAL KITS PVT IALC4/2015 and ltc―
indcxcd l
l lLTD, 15042015
‐ |
97 HQ lllC RLA Fnc Lic No/Datc:0410159504 Defer
‐
:01/82/050/01022/AM15/ :04′ 24/040/00171/AM15/ 129 09 2014 Datc:200520151
1 1)ccヽk)n:It was dccidcd tO deferthc casc fOr 20 05 2015 for commcnts of Dcpartmcnt of i
‐
Pharmaccuticals
Casc No.:178/13/82‐
AI´C4/2014
Paiy
Name:HINDUSTAN
POLYAMIDES&
FIBttS LIMITED
| |
Mcct No/DatcJ/82‐ status:Dcfrcrcd
iALC4/2015 and Rc― indcxcd
:5042015
HQ F‖ e RLA F‖ c Lic No/Datc:03 10789838 1Defer
101/82/050/01181/ノヽM15/ :03/94/040/00602/AM15/ 130 09 2014 1Datc:20052015
1)ccision:It w¨ dccidcd 10 dcfcrthc casc for 20 05 2015 for commcnts of Dcpartment ofC&PC
Casc No.:177/13/82-
Al´C4/2014
Pary Namc:KRISHNA ‐Mcct No Datc:1/82-
ANT10XIDANTS PVT IALC4/2015
115042015
Lic No/Date:03 10789849 1Dercr
lDatc:20052015
Status: Dcffcrcd
a nrl llc-indcrotl
I.TD
|‖ Q Filc
RLA Filc
:O1/82/050/01180/AM15/ :03/94/040/00586/AM15/ 130092014
Dccision : It was dccidcd to dcfer thc case for 20.05.2015 for commcnts of Dcpartmcnt ofC&pC.
C′lsc No:82/13/82-
Al′C4/2014
Pa“y Namc:MALLADI
IDRUGS&
PHARMACEUTiCALS
LIMITED
IMcct No/D7ate:1/82-
IALC4/2015
115042015
Status:Deffcrcd
and Rc-indcxcrl
loo ttg l,il"
RLA Filc
Lic No/Datc:041015951l Dcfcr
Palty Namc:TATVA Mcct No/Date:1/82‐
CHINTAN PHARMA ALC4/2015
101/82/050/01085/AM15/1:04/24/040/00160/AM15/i30092014
Datc:20052015
l)ccision : It was decided to defer the case for 20.05.2015 for comments of Department of
Phannaccuticals.
Casc No.:15/13ノ82_
Al′C4/2014
Status:Dcffcrcd
and Rc-indcxcd
CHEM PVT LTD
15042015
IHQ F‖ c lRLA Filc Lic No/Datc:3410040594 Dcrcr
Ю1/82/050/01018/AM15/S4/24/040/00161/AM15/30 09 2014 Date20 05 2015
Dccision:It was decided to defer thc case for 20.05.2015 for comments of Dcpartment of
C&1)C
1102
C.Isc No.:128/13/82_
Al′C4/2014
Party Namc:ALEMBIC
LIMITED
Mcct No/Date:1/82‐ status:Dcrrcrcd
ALC4/2015 and Rc― indcxcd
15042015
HQ File
RLA Filc
Lic No/Date:3410040601 Defcr
:01/82/050/01131/ノヽM15/ :34/24/040/00167/′ ヽM15/ 01 10 2014 Datc:20052015
1)ccision:It、vas dccidcd to dcferthc casc「Or 20 05 2015 for commcnts of Dcpartl■mt Of
駈
ヽ古ゞ3L!hi
Pharmaceuticals. Dccision :ln the light of written comments received from Petrochcrnical Division ofDepartrncnr of Chemicals and Petrochemicals vide their OM No. 14010167 /20t I -CHJI datcd 29.03.20 t 5, it was decided to call from the firm the following technical details: i) Dctailed manufacturing process along with balanced chemical rcaction indicating numbcr ol ,^. molcs ofall the rcactions. products and by-products with corresponding molecular Fonnulae, rur structural formulae, molecular weight and proccss flow diagram. ii) Stagc-wise perccntage yicld with respect ofcach of the reactants and products and the rclcvant justification enclosing therewith authentic printed tcchnical literaturc in support olyield or quantity of items for import. iii) Dctail ofby-products fonncd during the process and their rccovcry in terms ofqrantity and value. iv) Dctails of production of export product under reference and corresponding consumption of raw material in the year 2013-14 and 2014-15 (April to October) duly certificd by CA may bc fumishcd. If the production has not commenced in the past, the dctails from commencerncnt of .production may bc furnishcd duly certified by CA. The case was delerrcd for 29.04.2015 Party Narne:GUM Mcct No/Datc; l/82- ICasc No.:157/13/82- Pa■y Namc:AVA IALC4/2014 CHEヽ41CALS ‐ PVT LTD, IHQ Filc RLA Filc :01/82/050/01160/AIヽ415/ :03/94/040/00603/Aヽ415/ ICasc No.:19/1/82- AROMATICS PVT LTD Mcct No/Datc:1/82- ALC4/2015 15042015 ILic No/Datc:0310789905 Dcfcr l 01 10 2014 Datc:200520151 Strtus: t)cffcrcd and llc-indcrcd Status: I)cl lcl'cd and lte-indcrcd ‐ALC4/2015 ALC4/2015 115042015 1041HQ Filc RLA Filc Lic No/Datc10310789922 1)crc・r 101/82/050/01545/AM15/1:03/94/040/00594/AM15/101 102014 D.lte:20052015 1Dccislon:It was dccidcd to dcrcrthe case for 20 05 2015 for commcnts or Dcpartmcnt or C&PC ICasc No.:77/13/82- Party NamclMALLADI ALC4/2014 DRUGS& 1051繭訂― 101/82/050701080/AM15/ ‐RLA F‖ c 104/24/040/00164 AM15/ ‐Lic No/Datc10410159520 Dctr PHARMACEUTICALS iLIMITED ヽ4cct No/Datc:1/82‐ ALC4/2015 15042015 Sta tus: l)clTcrcd and Ilc-intlcxcd Status: I)cffcrcd and lle-indcxcd 01 102014 1)atc:20052015 Dccision : It was dccided to defcr the case for 20.05.2015 for comments of Dcparlment of Pharmaceuticals. CascNo.:160/13/82- PartyName:BAYER Mcct No/Datc:1/82- IA LC4/2015 115042015 Lic No/Datc:0310789976 Defc・r l 07 10 2014 Date,200520151 猟
コ Casc No.:13/13/82‐ IAl,C4/2014 107 HQ File Pany Name:FINE CURE McctNo/Date:1/82‐ IPHARMACEUTICALS IALC4/2015 1LTD 15 04 2015 Lic No/Datc:0810133503 Dcrcr Status:Dcffcrcd and llc-indcxcd RLA Filc 101/82/050/O1016/′ ヽM15/1:08/24/040/00233/AM15/ 107 10 2014 1Datc:20052015 :)ccision:it、vas dccidcd to dcrcrthe casc for 20 05 2015 for comments of Dcpartnnent of Phannaceuticals Ｆ Ｉ (〕asc No.:34/13/82- ALC4/2014 Party NameJUBILANT GENERICS LTD v."iNolort",ilsz- strtus:Approvc HQ Flle :01/82/050/01037/AM15 / RLA Filc :05/23/040/00258/AM15 1/ 10 18 Dccision : Commiltce considcrcd the case as pcr agenda and in light of writtcn comments i received from Departmcnt of Pharmaceuticals vide their OM No. 3501l/251l2014-Pl(Norms)' dated 18.03.2015 and in consultation wilh tcchnical authority present in meeting, dccidcd to, ratify norms under para 4.7 ofHBP as per details given below or as applicd by firm whichever is I lowcr:- I I Export product Exp Qty SI No lmport itcnrs Qty in mg for export of I Pantoprazole tablet 20 mR Tabs 40 mg tabs Pantoprazole Tablet l kg l Pantoprazole Sodiurn 21571 43 143 つ Mannitol USP (PCarlit。125C) 4244 8488 つ Sucrosc USNII 800 1600 4 Hypromellose (Pharmacoat 603 3cps) USP 186 372 RA concerned may take further necessary action as per above decision of NC. Party Namc:KしJ IMeet No/Date:1/82- IPLASTICIZERS LTD, IALC4/2015 115042015 (〕asc No:33/13/82- Al.C4/2014 Status: Approvcd HQ File :01/82/050/01036/AN415/ ,RLA File ,Lic.No/Date:05 10391459 Dcler :05/23/040/002561AM l51 107.10.2014 Darc:20.05.2015' 1109 1)ccision :ln the ight of written comments received from Department of Chemicals andl Petrochemica s vide their U O No 14010/36/2011-Ch ll dated 03 03 2015′ it was decided tol raJfy norms under Para 4 7 of HBP vl as per deta‖ s given below or as apphed by the irm,| Export product Exp Qty SI No lmport items Qty. allowed :い ,: 鰊盤 | whichever is less: C&1)C ― |
KANATOL-8080 1lkg 1 TERE PHTHALIC ACID 0 447 kg ETHYL HEXANOL 0 740 kg ― 一 RA may take appropriate action as per the decision of Norms Committee.. Casc No.:134/13/82- ALC4/2014 Party Name:MAHAVIR ,Meet No/Date: I /82- Status: Dcffcrcd and ll,e-indcrcd 110 HQ File :01/82/050/01 SYNTHESIS PRIVATE ALC4/2015 LIヽ41TED 15042015 IRLA Filc lLic No/Dttc:5210041251 Dcた r 137//ヽM15/1:52/24ノ040/00031/ノヽM15/ 107 10 2014 Datc:20052015 occi.ioo . it as A""io.a t" a"fo tft" "" f* zoofio f s fo. colnt*,ntt of o"punrn.nt oi C&PC. Casc No.■79/13/82- ALC4/2014 Party Name:AVA ICHEMICALS PVT LTD, Mect No/Datc:1/82- IALC4′ 2015 15042015 Status: Dcffclc(l and llc-indcrctl HQ Filc RLA Filc Lic No/Date10310790000 Doたr :01/82/050/01182/AM15/‐ :03/94/040/00622Aヽ415/ 108102014 I)atc:20052015 Dccision :ln the light oi written comments received from Petrochcmical Division ofDepartmcnt of Chemicals and Pelrochemicals vide their OM No. 14010/67i201 l-CHJI dated 29.03.201 5' it was decided to call from the finn the following tcchnical details: i) Detailed manufacturing process along with balanced chemical reaction indicating number ol'
- . - moles ofall the reactions, products and by-products with coresponding molecular Formulae, I I I slrucnrral lormutac. molecular weighl and proccss flow diagrarn. ii) Stage-wisc perccntage yield with respect ofcach ofthe reactants and products and the relcvant justification enclosing thercwith aulhentic printcd lechnical Iituaturc in support of yicld or quantity of itcms for import. iii) Detail ofby-products formcd during the proccss and their rccovcry in tcrms ofquantity and valuc. iv) Details of production ol export product undcr reference and corresponding consumption ol raw material in lhe year 2013-14 and 2014-15 (April to Octobcr) duly certificd by CA may bc furnished. If the production has not commenccd in the past, the details from commencemsnt of production may bc furnishcd duly ccrtified by CA. The case was dcferred for 29.04.2015 Casc No.:182/13/82‐ ALC4/2014 Party Name:AVA ICHEMICALS IPVT LTD, IHQ Filc ‐RLA Filc :01/82/050/01185/ノヽM15/ :03/94/040/00626/AIヽ415/ Mcct No/Datc:1/82- IALC4/2015 115042015 ILic No/Date10310790001 1)cたr 108102014 1)atc:20052015 Status: Dcl fcrcd nnd li.c-indcrcd 1 I 2 Dccision :ln the light ofwritten comments rcccived from Petrochemical Division of Dcpartmcnt ofchemicals and Petrochemicals vide their oM No. 14010167 /2011-cH-tl datcd 29.0i.2015, it .was decided to call lrom the firm the following technical details: i) Detailed manufacturing process along with balanced chemical reaction indicating numbcr of moles ofall thc rcactions, products and by-products with corresponding molccular Formulac, structural formulac, molecular weight and process flow diagram. 阻
ii) Stage-wise percentage yicld with respect ofeach ofthe reactants and products and the relevant justificalion cnclosing thcrewith authcntic printed technical literature in support ofyicld or quantity of items for import. iii) Dctail ofby-products formcd during the process and their rccovcry in tcrms ofquantity and valuc. iv) Details of production of cxport product undcr reference and corrcsponding consumption rarv rnaterial in the ycar 2013-14 and 2014-15 (April to October) duly ccrtified by CA may furnishcd. Ifthe production has not commenccd in the past, thc dctails lrom commencemcnt production may be furnishcd duly ccrtified by CA. The case was dcfcrrcd ror 29 04 2015 ｏｆ ｂ ｅ Ｊ Casc No.:29/13/82- AI′C4/2014 Casc No.:35/13/82- AI′C4/2014 Party NamcJUBILANT LIFE SCIENCES LIMITED Status: Deffcrcd and llc-indcxcd IDetr Date:15042015 Stalus: Dcffcrcd and llc-indexed IMcct No/Datc:1/82- IALC4/2015 115042015 1Lic No/Date:0510391491 :08102014 Party Namc:JUBILANT Mect No/Datc:1/82- LIFE SCIENCES IALC4/2015 LIMITED 15 04 2015 113 HQF‖ c RLA F‖ c lLic No/Date 101/82/050/01032/AM15/1:05/23/040/00268/AM15/:08102014 :0510391490‐ Derer IDate:20052015 I)ccision : It rvas dccidcd to dclcr thc casc for 20.05.)015 for commcnts of Dcparlrncnt ol Pharmaceuticals. ‖4 HQ Filc :01/82/050/01038/AM15/ RLA F‖c :05/23/040/00218/AM15/ I)ccision : It was decided to dcfer the casc for 20.05.2015 for comments ofDepartmcnt of l)harmaceuticals. Pany NamcSHASUN IMcet No/Dato 1/82- PHARMACEUTICALS IALC4/2015 LIM I「ED 15 04 2015 ‖5 HQ Filc RIンA「ilc ILic No/Date:0410159539 Defcr Datc: :01/82/050/01081/AM15/ :04/24/040/001731ヽM15/ 108102014 Dccヽion:It was dccidc‐ d to rc・」cctthC Casc as the■1‖ l has not furnishcd informajon desphe rcpcatcd reminders Casc No.:E6/13/82- Parly Name:SHASUN Meet No/Datc: l/82- Stttus: ALC4/2014 PHARMACEUTICALS IALC4/2015 1R● cctcd .LIMITED l15 04 2015 1 HQ Filc lRLA Filc iLic NげDatc:0410159540 1Dcrcr Date: Ю1/82/050/01089/AM15/ Ю4つ4/040/00172/AM15/18102014 1 19既 :話鳳 1話j棚 ::::iち蔦語 「 :轟 綱 “ 価 銚 お 1面 | 1)●cision:It was decidcd to rc」cctthe casc as thc rlrm has not furnishcd infoll‖ ation dcspltc l rcpeatcd rcminders l Casc No.:146/13/82- Pany Namc:RECKITT BENCKISER HEALTHCARE INDIA LIMITED (〕:tst・No.:78/13/82- Al′C4/2014 ´ ０ Mect No/Datc:1/82- IALC4/2015 115042015 Status: I)cffcrcd and llc-indcrcd |｀1) Al′C4/2014 ヽぎガうと!hi
HQ Filc RLA Filc Lic No/Datc:051039151l Dcrcr
i01/82/050/01149/Aヽ415/ :0524/040/00304/AM15/ 09 10 2014 Datc:20052015
Dccision : lt was decided to defer the case for 20.05.2015 for comments of Department of
Pharmaceuticals.
IParty Name:SHASUN Mcct No/Datc:1/82 Status:RcicctCd
PHARMACEUTICALS ALC4′
2015
1LIMITED 15 04 2015
118 HQ Filc RLA File Lic No/Datc:0410159552 Dcfcr Datc:
:01/82/050/01086/AM15/1:04/24/040/00187/AM15/ 109102014
Dccision : tt was decided to reject the case as the firm has not furnished infonnation dcspitc
rcpcated rcminders.
Casc No.:83ノ13′82-
ALC4/2014
Casc No.:275/13/82‐
ALC4ノ2014
H9HQ Filc
:01/82/050/01278/AM15/1:08/24/040/00259/AM15/110102014
15042015
Lic No/Datc:0810133557 Dcfcr
Dttc:20052015
occhion : it *as aeiia"o to aiiiiitJ"J r io.osi0t5 for comments otbefa.fient or
Pharmaceuticals.
Party Namc:CAPLIN Mcct No/Datc:1/82‐ Status:Dcrrcrcd
lPONT IALC4/2015 and Rc―
indcxcd
LABORATORIES LTD, 15042015
‐
120 HQ File lRLA Filc Lic No/Date:0410159566 1Dcfcr
:O1/82/050/01079/AN415/1:04/24/040/00163/Aヽ415/ 113 10 2014 1Datc:20052015
:)ccision:It、vas dccidcd to dcrcrthc casc for 20 05 2015「
or coinmcnts of Dcpanincnt Of
Pharinaccuticals
Casc No.:76/13/82-
ALC4/2014
Casc No.:140/13/82-
ALC4/2014
Party Namc:MICRO Mcct No/Datc:1/82-
LABS LTD ALC4/2015
Status: I)cffcrcd
and llc-indcxcd
15042015
12「HQ File :RLA File Lic No/Datc:0710106816 Dcrcr
:01/82/050/O1143/AM15/1:07/24/040/00228/AM15/ ‐13.10 2014 1Datc:20052015
Dccision : It was decided to defer the case for 20.05.2015 for comments of Department of
Pharmaceuticals.
lヽ4cct No/Date:1/82‐ Status:I)crrcrcd
IALC4ノ2014 CIIEMICALS& AI_C4/2015 and ltc―
indc、cd
‐ PHARMACEUTICALS 15 04 2015
1LIMITED
HQ F‖ c RLA File Lic No/Datc:03107902371Dctr
:01/82/050/01187/AM15/1:03/94/040/00675 AM 15/114 10 2014 1Datc120 05 2015
1)●cision:it、vasdccidcdlodcFcrthccascfor20052015 forcOmmcntsofDcparimcntor
Pharmaccuticals
Status: l)cffcrcd 儡
123 Casc No.:272/13/82-
Parfy Name:SAIBABA Meet No/Date:l /82-
:LTD
:RLA Filc
Party Name:CADILA Mcct No/Datc:1/82- Status:Dcrrt・rcd
PHARMACEUTICALS ALC4/2015 and Rc―
in(Icxc(l
Al′C4/2014 SURFACTANTS(P) Al´ C4/2015 and ltc― indoxcd LTD, 15042015 HQ「‖c RLA Filc Lic No/Datc:0810133587 1Dcrcr :01/82/050/01275/AM15/1:08/24/040/002491ヽM15/ l14.10 2014 1Datc:20052015 1)ccision:It was dccided to deferthc case for 20 05 2015 for comments ofDepartment of C&PC Casc No.:163/13/82- A LC4/2014 HQ Filc :01/82/050/01166/AMi5/ Party Namc:SM .Mcct No/Date:1/82- ICHEMICALS IALC4/2015 ‐ 15042015 ‐RLA Filc :03/95/040/00450,Nヽ415/ Status: I)cffcrcd and l{e-indcxcd 124 Lic No/Date:03 10790285 1Dcfcr 16 10 2014 1Date:20052015 l)rcision :ln thc light of written commenls rcccivcd from Pctrochcmical Division ofDepartrnent of Chcmicals and Petrochemicals vide their OM No. 14010/641201l-CH-ll dared 25.03.2015, ir rvas dccidcd to call ftom the firm the following tcchnical details: i) Dctailed manufacturing process along with balanced chemical reaction indicating number of moles ofall the reactions, products and by-products with corresponding molecular Formulae, structural formulae, molecular wcight and process flow diagram. ii) Stagc-wisc percentage yield with respcct ofeach ofthe reactants and products and the relevant justification enclosing therewith authentic printed technical literature in support ofyield or quantily of items for import. iii) Dctail ofby-products formed during the proccss and their rccovery in terms ofquantity and valuc. iv) Dctails of production of export product under referencc and corresponding consumption of raw matcrial in the year 2013-14 and 2014-15 (April to Octobcr) duly certified by CA may be furnished. Ifthc production has not commcnccd in thc past, the details from commcnccment of production may be furnished duly certified by CA. 'I'hc case was dcfcrred for 29.04.2015 N4cct No/Datc:1/82- ALC4/2015 15042015 1Lic No/Datc:0310790361 17102014 Casc No.:155/13/82‐ Al´ C4′ 2014 HQ「ilC Party Namc:AVA ICHEMICALS IPVT LTD, RLA Filc Status: Deffcrcd and I{c-indcxcd Dcfcr Datc:20.05.20I 5 :01/82/050/O1158/Aヽ415/103/94/040/00658/AM15/ l)ecision :ln the light of written commcnts rcceived from Petrochcmical Division ofDepartmcnt ol Chcrnicals and Perrochcmicals vide their OM No. l40l 0/671201 l -CH-ll dated 29.03.2015. it was decided to call from the firm the following tcchnical dctails: 125 i) Delailcd manufacturing process along with balanced chemical reaction indicating number of rroles olall the reactions, products and by-products with corresponding molecular [ormulae, structural formulac, molecular weight and process flow diagram. ii) Stage-wisc pcrccntage yield with respcct ofcach ofthe rcactants and products and the relevant justification cnclosing therewith aulhcntic printcd tcchnical litcrature in support ofyield or quantity of items for import. iii) Dctail olby-products formed during the proccss and thcir recovery in lcrms ofquanrity and valuc. iv) Details of production of export product undcr rclcrcnce and corrcsponding consumption of raw matcrial in the year 2013-14 and 2014-15 (April to Ocrober) duly certified by CA may bc furnished. If the production has not commenccd in the past, the details from comitr'etrcement ol, 駈 へL К υ MAR Iマ子 =「ЧTて γじ10`ヽTrade 1 :じじ Dt: Onector G.',rd,. &r ..arqr-. Dla€ctorale Gener. 司やヽo鰤囁,〃oepa“ moハtO(Co●l‐ rce udy。泥摺蔦議肝乱lm
production may be furnishcd duly certified by CA. The case was dclcrred for 29.04.201 5 Casc No.:183/13/82- iALC4t20t4 i r26 iHQ File--. P征りName:BLISS GVS IMcct No/Datc:1/82‐ IPHARMA LTD IALC4/2015 1 11504.2015 Stalus: l)cffcrcd and llc-indcxcd RLA Filc Lic No,I)atc10310790362 1)crt・r 101/82/050/01186/AM 15/ :03/94/040/00689/AM15/ 17102014 Datc120 05 2015 Dechion : li was decided to deler the case for 20.05.2015 lor commenrs ofDepartmenr of Pharmaceuticals. Casc No.:136/13/82- Party Namc:DHANUKA McctNo/Datc:1/82‐ ALC4/2014 LABORATORIES LTD ‐ALC4/2015 115042015 Status: Dcffcrcd and llc-indcxcd 1127 HQ Filc ltLA Filc Lic No/Datc:0510391614 Dcrcr :01/82/050/O1139/Aヽ415/ :05/23/040/003091ヽヽ415/17102014 Datc:20052015 Dccision : It rvas dccidcd to defcr tle Li" fo, iO.OS.zo t i tor commenrs of Dclarrmenr of Pharmaccuticals. Casc No.:154/13/82- ALC4/2014 Pary Namc:GEM AROMATICS PVT LTD Mcct No/Datc:1/82‐ ALC4/2015 115042015 Status: l)cffcrcd and llc-indcxed 128 IHQ Filc RLA Fllc Lic No/Datc:0310790351 Derer :01/82/050/01157/AM15/ :03/り4/040/00680/AM15/ 17 10 2014 Datc:20052015 ‐Dccision:It was dccidcd to dcfcrthc casc ror 20 05 2015 for commcnts Of Dcpartincnl o「 C&PC Casc No.:164/13/82- 131 ALC4/2014 Pa“y Namc:SUN PHARMACEUTICAL INDUSTRIES LTD, Mcct No/Datc:1/82- A LC4/2015 15042015 Status: l)clfcrcd and llc-indcrcd S(atus: l)cfl'crcrl and llc-indcrctl Casc No.:124/13/82- P征りName:PANACEA Mcct No/Datc:1/82- ALC4/2014 BIOTEC LTD, ALC4/2015 115042015 1291HQ Filc RLA Filc Lic No/Datc:0510391623 Dcfcr :01/82/050/01127/AM15/1:05/24/040/00319/AM15/ 17102014 Datc:20052015 ticcision r ir was dccided ro deler the casc l-or 20.05.201 5 lor commcnrs of Deparlrnenr of Biotechnology. Casc No.:135ノ13/82- Pally Nainc:SHREE Mcct No/Datc:1/82- Status:Dcfttrcd ALC4/2014 BANKEY BEHARILAL ALC4/2015 and Rc_indcxcd AROMATICS 15 04 2015 130 HQ Filc itLA Filc Lic No/Date10510391639 DcFcr :01/82/050/01138/AM15/ :05/24/040/003061ヽM15/ 117102014 I)atc:20052015 Decision : tt was decided to defcr the case for 20.05.2015 for commcnts of Dcpartmcnt of C&PC.
IHQ F‖ c lRLA File Lic No/Date:0310790332 1Dcrcr l :O1/82/050/01167/Aヽ415/::03/95/040/005931ヽM15/ 117 10 2014 1Datc:200520151 ＝ 一 D""i.i;;lt ;* d""id"d to d"f
I
Pharmaceuticals.
i
Casc No.:165/13/82‐
AI′C4/2014
Party Name:SUN Meet No/Datc:1/82‐
PHARMACEUTICAL IALC4/2015
1NDUSTRIES LTD, 15042015
Status:Dcffcrcd
and l{c-indcxcd
132 HQ File RLA File Lic.No/Datc:0310790350:Defer l
輩鮮器尋∬蝋鶴辮磋器鵞品橘轟需Ψ写
Pharmaceuticals. I
I Casc No:152ノ13/82- Party NameJNDOCO IMeet No/Datc:1/82- Status:Dcrrc・
rcd l
AI´C4/2014 REMEDIES LIMITED IALC4/2015 1nd Rc―
indcxcd l
15042015 1
133 HQ Fnc lRLA File Lic No/Datc:0310790392 1Dcrcr i
:01/82/050/01155/AM15/:03/947040/00692/AM15/20 10 2014 Datc20 05 20151
1)ccision: lt、vas dccidcd to dcrcrthc casc for 20 05 2015 for comments of Dcpaimcnt of
‐
I Pharmaccuticals
Casc No.:132/13/82- Party Namc:MOREPEN Mcct No/Date:1/82-
Al′C4/2014 1LA30RATORIES LTD,IALC4/2015
15042015
StatusiDcffcrcd
and llc-indcxcd
134 HQ「ile lRLA Filc Lic No/Datc:0510391643 Dcrcr l
:01/82/050/O1135/AIヽ415/1:05/24/040/00322/AM 15/ 120 10 2014 1Datc:200520151
Dccもlon:It was dccidcd to dctrthc casc ror 20 05 2015 for commcnts orDepartmcnt Of l
I'harmaccuticals.
Casc No:144/13/82- Party Name:PAYAL Meet No/Datc:1/82‐
Status:Dcffcrcd
Al.C4/2014
PETROCHEM
ALC4/2015
and llc-indcrcd
IPRIVATE LIヽ41TED 15 04 2015
1135 HQ Filc lRLA Filc Lic No/D・atc:0510391660‐ Dcrcr
:01/82/050/O1147/7ヽM15/1:0524/040/00293/AM15/ 20 10 2014 Datc120 05 2015
I)ccision : It \yas decidcd to dcfcr the casc for 20.05.2015 for commcnts ofDeparlment of
C&PC.
Casc No.:145/13/82- Party Name:PAYAL Meet No/Datc:1/82‐
Status:Dcfrcrcd
ALC4/2014 PETItOCHEM .ALC4/2015 and ltc―
indcxcd l
PRIVATE LlMITED 15 04 2015 1 1
r―‐u…ν…脚lLttbc缶 |
HQ File lRLA Filc :LicNo/Da
鶉
臨
譜
詈
|:01/82/050/0‖ 48/AM15/:05/2
1Dccision:It was decidcd to def
C&PC
」
1136
137X従漁llyBお
2_
キ、
Party Namc:RI]CKIT「 ヽ4cct No'I)atc:1/82- Status:Dcfft・
icd
BENCKISER ALC4′ 2015 and la`indcxcd
py得罫蹴憚引:謙輔
赫
n■■Do,3■,■
'ハ
t。I COmmerce
ud寅聾轟慕誡
IⅢ
HQ Filc HEALTHCARE INDIA 15 04 2015 LIMITED RLA Filc Lic No/Datc:0510391644 Dctr :01/82′050/01141/AN415/ .:05/24/040/00330/AM15/ 20102014 Datc:20052015 Dccision : It was decided to defer the case for ZO.OS.ZO t S for comments of Department ol Phannaceuticals. Casc No.:139/13/82‐ Pary Namc:RECK17‐「 Mcct No/Datcl1/82‐ Status:Dcrrcrcd ALC4/2014 BENCKISER IALC4/2015 and Rc― indc、cd HEALTHCARE INDIA 15 04 2015 LIMITED 138‐ HQ Filc RLA rilし Lic No/Datc:0510391645 Dctr 101/82/050/01142/AM15/ 105/24/040/00325/AM15/.20 10 2014 Datc:20052015 Dccision:It was dccl‐ dcd to deferthe casc For 20 05 2015「 orcommcnts orI)。partmcnt of Pharmaccuticals Casc No.:169/13/82- ALC4/2014 ‐Party Namc:YASIIO IMCCt No/Datc:1/82‐ INDUSTRIES PVT LTD IALC4/2015 115042015 Strtus: I)cffcro(l rnd llc-indcrctl 1391HQ Filc RLA Filc Lic No/1)atc:0310790376 Dclt‐ r | :01/82/050/01172/AM15/ :03/95/040/00602/AM15/ 20 102014 D7atc:20052015 1 1Dccision:It was dccided to dcfcr thc casc for 20 05 2015 ror colllmcnts of Dcpartincnt of l lc&Pc Casc No.:153/13/82- ALC4/2014 PなりNamc:DORF― Mcct No/Datc:1/82- KETAL CHEMICALS A LC4ノ2015 INDIA PVT LTD 15042015 HQ F‖ c RLA Filc Lic No/Datc:0310790442 Dctt・r 101/82/050/01156/AMi5/1:03/94/040/00677 AM15/121 102014 D“ c:20052015 1)ccislon:It was dccidcd to dcfcrthc casc for 20 05 2015 for coinmcnts o「 I)cparilncnt or C&I)C Status: l)cffcrc(l and llc-indcrcd i140 Casc No.:129ノ13/82_ ALC4/2014 Party Mect No/Datc:1/82- INamc:GULBRANDSEN ‐ AIレC4/2015 1CHEMICALS PVT LTD 15 042015 Status: Dcffcrcd 1lnd I{c-indcxc(l 1411 IlQ File RLA File Lic.No/Date:3410040631 Defer :01/821050/01132/AMl5/ :34124/040/00189/AM l5/ 21.10.2014 Date:20.05.2015 Dccision :lt was decided to remind the firm to furnish the following information:
- Detailed manufacturing process along with balanced chemical reactions indicating number of moles of all the reactants, products and by-products with corresponding molecular formulae, structural formulae, molecular weight and process flow diagram.
- Stage-wise percentage yield with respect of each of the reactants and products and the relevant justification enclosing therewith authentic printed technical literature in support of yield or quantity of items for import.
- Details of by products formed during the process and their recovery in terms of quantity and value .
- Denials of production of export product under reference and corresponding ¨ ′ “ ヽ い指器 ↑l「 ヘ Dy磐罫lli、 精 鶴|「1_ ud課鵡認占 rヽ 温 lhi
consumption of raw material in the year 2013-14 and 2014-15 (April to October) duly
certified by CA may be furnished duly certified by CA. lf the production has not
commenced in the past the details from commencement of production may be
furnished duly certified by CA. Any other relevant information.
5. Any other relevant information, if any
The case was deferred for 20.05.2015.
Party NalllciS M B IMcct No/Datc:1/82- Status:Dcrrc・rcd
CORPORAT10N OF AI′ C4/2015 and Rc― indcxcd
INDIA 15 04 2015
‐
142 HQ Filc lRLA Fne Lic No/Datc:0310790431 Dcfcr
:O1/82/050/01170/AM15/1:03/95/040/00610/AM15/121 102014 1)atc:20052015
1)ccision:It、vas dccidcd tO dcrcrthc casc ror 20 05 2015 for cOmmcnts OfDepanment OF C&PC
(PC D市iison)
Casc No.:130/13/82-Pany Mcct No/Date:1/82‐ ‐Status:Dcrrcrcd
Al.C4/2014 Name:ALEMBICPHARMACEUT ALC4/2015 and Rc―
indcxcd
ICALS LTD 15 04 2015
‐
Casc No.:167/13/82-
AI′C4/2014
14
D
HQ Filc
ltLA File
:O1/82/050/01133/A :34/24/040/00187/AM15/
M15/ 1
l)ccision : It was dccidcd to defer the case for 20.05.2015 for comments of Oefu.tment of
Pharmaceuticals.
一
Casc No:171/13/82_
AI′C4/2014
Party Namc:PIIASOL
Mcct No Datc:1/82-
IALC4/2015
15042015
CHEMICALS LIMITED
Status: I)cffcrcd
and llc-indcxcd
: |
144 HQ Filc
IRLA File
Lic No/Date:0310790482 Defer
:01/82/050/01174/AM15/1:03795/040/00588/AM15/ 22102014
Date:20052015
Dccision : It was decided to defer lhe case for 20.05.2015 for comments ofDepartment of
C&PC.
Casc No:172/13/82-
Palty Namc:PRASOL Mcct No/Datc:1/82- Status:Dcrfcrcd
CHEMICALS LIMr「ED AI´ C4/2015 and Rc― indcxcd
A:′C4/2014
15042015 1
145 HQIヽlC IRLA Filc Lic No/Datc:0310790480 1Dcrcr
:O1/82/050/01175/AM15/1:03/95/040/00362/AM15/ 22 10 2014 1Datc:20052015
1)ccision:Itwasdccidedlodeferthecasefor20052015forcommcntsofDcpanmcntOr
C&1)C
Casc No.:170/13/82_
Al.C4/2014
IParty Namc:SAVLA
ICHEMICALS LIMITED
Mcct No/Date:1/82-
Status:Dcffcrcd
and llc-indcxcd
ALC4/2015
15042015
146 l tq l,it"
RLA Firc
:0 I /821 050 t 0l l7i / AMI 5 / :03 /9 5 I 040 I 006 I 9/AM I 5/
Lic No/Dttc:03!0790490‐ Dcrcr
22102014 1)ate:20052015
l)ccision : lr rr as dccidcrl to dcfer thc casc lor 20.05.2015 lbr commcnls of Dc-partnrcnt of
⌒ Ilc-indcrrtl Ilc-indcrttl llc-indcrcd 15042015 I]ilc 196/AM15/ 27102014 10159624 1Dcrcr iDatc:20052015 :01/82/050ノ01090/AM15/ : It rvas dccided to dcfcr the case lbr 20.05.2015 for commcnts of Dcpartmcnt of No.::25/13/82- Name:KLJ No/Datc:1/82- 14 15 Ilc-indcxcd 15042015 Filc 10391766 1/82/050/01128ノンヽM15/ 13/ノヽM15/ 28102014 : It was decided to defcr thc casc for 20.05.201 5 for com ments o f Departmcnt ol Namc:KLJ No/Datc:1/82- llc-indcrcd 15042015 : It、vas dccidcd to dcfcrthc casc ror 20 05 2015 for commcnts or Dcparinlcnt of : It was decidcd to defer the casc for 20.05.2015 lor comments of Departmcnt of No:110′ 13/82- Namc:TATVA No/Datc:1/82‐ 148 HQ Filc lRLA Filc Lic No/Datc:3410040635 111/82/050/OI H3/AMi5/34つ4Ю407o0188/AM15/22102014 14 AN PHARヽlA PVT LTD 15042015 : It was decidcd to defcr the case for 20.05.20 I 5 lor commcnts of Dcpartmcnl of No/Datc:1/82‐ No.:141/13′ 82- Party Mect No/Datc:1/82- INamc:YASHASHVI .ALC4/2015 1RASAYAN PVT LTD ■5042015 4 10041283 Ilc-indcrcd C&PC Casc No.: I l6113/82- Party Name:SHANPAR Meet No/Date: I /82- A LC4/2014 NDUSTRIES PVT LTD A LC4/2015 15042015 C&PC HQ Filc RLA Filc it」乱い
Ю1/82/050/O H44/AM15/5224/040/00040ハM15/う01ibわbi4 Dac20 05 20151 1)ccおlonJn thc light Of writcn commcnts rcccivcd from Pctrochcmical D市 islon of Depanmentl of Chcinicals and i〕ctrochcmicals vidc thcir Oヽ4 NO. 15022/17/2012‐ PC-1l datcd 17 03 2015,it l ヽヽ′●OH‐´ :月^月1^´ 。11「^,l.0■… ,l.●、 11^、,,:～ `^^I● |●:^1月^●:: was dccidcd to call from the firm the following technical details: i) Detailed manulacturing process along with balanced chemical reaction indicaling numbcr of moles ofall thc rcactions, producls and by-products with corresponding molecular l.ormulae, structural formulac, molccular weight and process flow diagram. ii) Stage-wisc pcrccntage yicld with respcct ofeach ofthe rcactants and products and the relevant justification enclosing therewith authentic printcd technical literature in support ofyield or quantity of itcms for import. iii) Detail ofby-products formcd during thc proccss and thcir rccovcry in tums ofquantity and value. iv) Dctails of production of export product undcr reference and corresponding consumption of raw material in the year 2013-14 and 2014-15 (April to Ocrober) duly certified by CA may bc fumishcd. Ifthe production has not commenced in the past, the details from commencement of production may be furnishcd duly certified by CA. The case was delcrred for 20.05.2015 ICasc No.■04/13/82- IAl,C4/2014 153 HQ Filc Party ilame:AMOL Mect No Datc:1/82- PHARMACEUTICALS ALC4/2015 PVT LTD 15042015 Sla tus: I)cffcrcd and llc-indcxcd RLA Filc Lic No′1)ate■310047687 Dercr :01/82/050/01107/AM15/ .:13/24/040/00029/AM15/105 112014 Datc:20052015 Dccision : II was dccided to defer the case for 20.05.2015 for commenrs of Ocpa.tment oi C&PC. Casc No.:266/13/82- AI′C4/2014 154 HQ Filc Party Name:ATUI´ LIMITED, Mcct No7Datc:1/82- IALC4/2015 15042015 Status:Dcffcrcd' and Rc-indcxcd. Casc No.:268/13/82‐ AI´C4/2014 155‐ HQ File Party Namc:ATUL LIMITED, RLA Filc Lic NoノDate10810133735 Dcfcr 101/82/050/O1269/AM15/1:08/24/040/00289/AM15/ 05112014 Datc:20052015 Dccision : It was dccided to defer the casc for 20.05.2015 lor comments of Dcpartmcnt of C&PC. ヽ4cct No/Datc:1/82‐ ALC4/2015 15042015 RLA Flle IJc No/Date10810133734 Dercr :01/82/050/01271/AIN11 5/ :08/24/040/00283/AM15/ 105112014 Datc:20052015 Dccision : tt was dccided to defer the case lor 20.05.2015 for comments of Dcpartment of C&PC. 扇 iWII IW帯Iむ'IW‖ “"Wih 1)atci20 05 201が :01/82/050/01110/AIヽ415/ :34/24/040/00196んへM15/ 105 112014 Status: Deffcrcd and llc-indcxcd l
Decision : It was decided to defer the case for 20.05.2015 for commcnts of Dcpartment of
IC&PC
Status: l)cffcred
and Rc-indcxcd
:ALC4/2014
1571HQ File
NOBEL rNDIA
LIMF「ED
RLA File
ALC4/2015
15042015
1_ic No/Datc:0210205126 1)cた
r
:01/82/050/O1124/AM15/ :02/24/040/00111/ノヽM15/ 0711 2014
Datc:20052015
Decision : It was dccided to dcfer the case for 20.05.2015 for comments o[ Dcpartment o I
C&PC.
CascNo.:267lt3/82- Pa(yName:ELIXIR
IALC4/2014
Mcct No′ 1)atc:1/82-
ALC4/2015
Status: I)cffcrcd
and Re-indcxcd
PHARMA
| | 115.042015
‐
1581HQ Filc lRLA Filc Lic.No/Datc:0810133743 1Dcfcr
:01/82/050/01270/AM15/1:08/24/040/00294/AM15/ 07112014
Datc:20052015
Dccision : It was dccided to dcfer the casc for 20.05.2015 for commcnts of Dcpartment of
Pharmaccuticals.
ICasc No.:1/13/82‐
:ALC4/2014
IParty Namc:HETERO Mcct No/Datc:1/82- status:Dcrrcrcd
lLABS LIMITED .ALC4/2015 and Rc― indcxcd‐
: ‐ 115042015 1
1591HO●le :、
LA Rlc l日
c No′ЭatcЮ 91006H 88 Dcrcr
101/82/050Ю 1004/AM15/:09/24/040/00417/AM15/07H2014 Datc:20052015
Dccision : It was dccided to delcr the case tor 20.05.20 l5 for commcnts of Dcpartrnent ol
Pharmaceuticals.
ICasc No.:2ノ13/82- 1)arty Namc:ATUL N4cct No/Datc■ノ
82‐ Status:Dcrrt・lcd
lALC4/2014 LIMITED, ALC4/2015 and Rc―
indcxcd
15042015
IC&PC
IParty lMcct No/Datc:1/82‐ status:1)crrcrcd
Namc:AUROBINDO
‐ALC4/2015 and Rc■ndcxcd
PHARMA LIMITED 15 04 2015
161 HQ Filc RLA Filc Lic No/Datc:0910061197 DcFcr l
101/82/050/01006/AM15/:09/24/040/00377/AM15/10H2014 Datc:200520151
1Dccision:It was dccidcd to scnd thc copy ofapplicatiOn tO Dcpanmcnt OfPharmaccudcalsおr
thcir cOmmcnts l｀he case was dcfcrrcd for 20 05 2015
Casc No.:3/13/82-
‐ALC4/2014
Casc
1162 ALC4/2014
1 :HQ Filc ~
No.:265/13/82- Party
Mect No/Datc: l/82-
Sratus:Dcffcrcd
Namc:HJ AROCHEM ALC4ρ 015 and Rc― indcxcd
PVT LTD,
15042015
~IRLA RL ~~~~~Uα
No/Datα 0810153768 Dcfcr
:h
1601HQ Filc RLA F‖ c Lic No/Datc:08101337621)●「cr
l11/82/050/01005/AM15/:08/24/040/00290AM 15/‐ 10H2014 Dato20 05 2015
1Dccislon:It was dccidcd to dcferthe casc for 20 05 2015 for comincnts of Dcpartmcnt of
:01/82/050/01268/AM15/ :08/24/040/00265/メヽヽ415/ 1101:2014
Date:20052015
Dccision : h was decidcd to dcfcr the casc for 20.05.2015 for commcnts of Dcpartment o I
C&P(｀
Casc No.:151/13/82-
Status: Defferctl
,rnd Ilc-indcxcd
AI′C4/2014
163
Casc No.:114/13′ 82- 1)arty Name:V‖ tDEV Mect No′Datc:1/82- Status:Dcrrcrcd‐
ALC4/2014 1NTERMEDIATES PVT IALC4/2015 and ltc― indcxcd‐
LTD 15 04 2015
1641HQ Filc RLA Filc Lic No/Date:5210041292 1Defer
:01/82/050/01l17/AM!5/1:52/24/040/00042/AM15/ 110 11 2014 Date:20052015
Dccision : It was dccidcd to defer the case for 20.05.2015 for comments ofDcpartment of
C&PC.
Casc No.:4/13/82- Parly Namc:ASTRIX Meet No/Date: l/82-
Casc No.:111/13/82- Palty Name:ABEERS IMeet No/Datc■/82- Status:DcfFcrcd
ALC4/2014 ,PHARMACEUTICALS IALC4/2015 and ltc―
indcxcd
lPVT LTD 15 04 2015
165 HQ「ilC IRLA File Lic No/Datc:0510391927 Dcfc・
r
:01/82/050/01114/´ 、Mi5/1:05/23/040/00352/AM 15/:ll 11 2014 Datc:20052015
Dccision:It was decidcd to dcrcrthe casc for 20 05 2015 for commcnts ofDcparimcnt of
AYUSH
ンヽ1,C4/2014
166 HQ Filc RLA Filc Lic No Datc:09100612 H Dcfer
:01/82/050/01007/AM157 1:09つ4/040/00409/AM15/111 11 2014 Date:20052015
Dccision:it was dccidcd to defcrthc casc for 20 05 2015 1Dr commcnts orDcpartment of
Pharinaceuticals
ILABO時ヽTORIES LTD, ALC4/2015
15042015
Status: Dcffcrcd
and llc-indcxcd
Casc No.:5/13′ 82- ‐Party Name:ASTRIX Meet No Datc■
/82- Status:Dcffcrcd
lAl.C4/2014 1LABO時ヽTORIES LTD,IALC4/2015 and Rc‐ indcxcd
115042015
167 HQIヽlC
‐RLA Filc Lic No/Datc:0910061212 Derer
101/82/050/01008/AM15/ 1:0924/040/003257AM 15/111 11 2014 11)ate:20052015
Dccision:It was decidcd to dcrcrthe casc for 20 05 2015 for commcnts of Dcpartmcnl of
l)harinaceuticals
Casc No.:108/13/82-
168‐ AI′C4/2014
Party Namc:SHREE
BANKEY BEHAtt LAlッ
BOARDヽ41L[′ S
Mect No/Datc:1/82-
StNtus: l)cffcrc(l
lnd ltc-indcrcrl
ALC4/2015
15042015
tl
l.{ew oelhr
:01/82/050/01154/AM15/ 1:03/95/040/00631/AM15/11011 2014
Datc120 05 2015
Dccision : lt was decided ro deler the case for 20.05.2015 for commenls of Dcpartment of
Pharmaccuticals.
IIQ Filc RLA Filc Lic No/Datc:0510391926 Dcrcr l
101/82/050/01111/AM15/1:05/24/040/00347 AM 15/111 11 2014 1Datc:200520151
1Dccision:It、vas dccidcd to dcFcrthe casc for 20 05 2015 for commcnts ofDcpartmcnt of
‐
IC&PC
| ICasc No.:112/13/82_ Palty Nalne:SOLARIS i卜leC・t No Datc:1/82‐ Status:Dcrrcrcd
i lALC4/2014 .CHEMTECH IALC4/2015 and ltc indcxcd
l 1 lNDUSTRIES LTD 15 04 2015 1 1
169 HQ Filc RLA Filc Lic Noノ
つatc:3410040672 1Dcfcr l
: :01/82/050/01115/AM15/1:34/24/040/00193/AM15/111 11 2014 1Date:20052015
: IDccision:It was dccidcd to dcfcrthc casc for 20 05 2015 for cOmmcnts of Dcpartmcnt Of
l lC&PC
CascNo.:7/13/82- PartyName:HETEIIO MectNo/Date:1/82- Status:Dcffcrcd
ALcl/20t4
LABS LTMITED iir?illT
and lrc-indcxcd
I 70 HQ File
RLA File
Lic.No/Date:0910061 2ll Delcr
:01/821050/01010/1.'}ll5/ :091241040100446/AMl5l 12.11.2014
Datc:20.05.2015
Dccision : It was decidcd to deler the case for 20.05.2015 lor comments of Dcpartmcnt oI
Pharmaceuticals.
I Casc No■120/13/82- Farty Name」UBILANT IMca NoDate1/82- Statu∬
DcfFcrcd
l lALC4/2014 1LIFE SCIENCES IALC4/2015 1nd Rc―
indcxcd l
l : ILIMITED
■5042015 ‐ |
,71 HQ Filc~~~~~ ~~― llRLA rilc~
――― ――――
lidNo75ム16ib,id5,1,47Dさ
“
F I
I IЮ 1/82/050/01123AM15/Ю 523/040Ю 0325/AM15/12H2014 1Date20 05 20151
1 1Dccision:It was decidcd to dcfcrthc casc for 20 05 2015 for commcnts ofDcpartincnt of l
l lPha‖ ‖accuticals
| ICasc No.:105/13/82- Pany Namc:PAYAL
I IALC4/2014 PETROCHEM
I I :PRIVATE LIMITED
Mcct No/Datc:1/82-
:ALC4/2015
115、042015
Status: l)effercd
and llc-indexcd
７
一
IHQ Filc :RLA Filc
101/82/050/O1108/Aヽ415/1:05/24/040/00336/AM15/
Lic No/Datc:0510391957 Dctr
12 11 2014 Datc:20 052015
IDocision:It was dccidcd to dcfcrthc casc for 20 05 2015「or comlncnts orDcpartinncnt of
IC&PC
1
,
|
ICasc No.:9/13/82-
IALC4/2014
IALC4/2015
115042015
Party Namc:HETERO IMcct No/Datc:1/82-
:DRUGS LIMITED
Status: DclTcrcd
and llc-indcxcd
1731HQ Filc lRLA Filc Lic No/Datc:0910061268 1Dcfcr
101/82/050/01012/AMi5/1:09/24/040/004531ヽM15/119 11 2014 1Datc120 05 2015
1Dccision:Itwasdccidcdtodcfcrthccascfor20052015forcOinmcntsofDcpartmcntof l
lPha:‖ [accuticals
Party Namc:HETERO
LABS LIMITED
曰
4愛縫胤響脚8ト
Mcct No/Datc:1/82‐
IALC4/2015
Strtus: Dcffercd
and llc-indcxcd
D)
焦がい
…
'1‐ “ le 」 ギ
1・|.il・I・J∝
15042015
HQ F‖c RLA File Lic No/Date:0910061269 1Dcfcr
:01/82/050/01013//ヽMi5/1:09/24/040/00449 AM15/ 119 11 2014 1Datc:20052015
1)ccision:It、vas dccidcd to defcrthc casc for 20 05 2015 for comments of Dcpartmcnt of
I)harmaccuticals
Casc No.:11/13/82- Party Nainc:HETERO ,Mcct No/Datc:1/82- Status:Dcfrcrcd
Al,C4/2014 ‐LABS LIMITED IALC4/2015 and Rc‐ indcxcd
15042015
175 HQ Filc RLA Filc Lic No/Date:0910061271 Dcfer
101/82/050/01014/′ ヽNl1 5/ :09/24/040/00460/ノヽM15/ 19 11 2014 Date:20052015
l)ccision : It was dccided to defcr thc case for 20.05.2015 for comments of Dcpartment of
Phannaceuticals.
Casc No.:122/13/82- Pany Namc■)AYAL IMcct No Datc:1/82- Status:Dcrrcrcd
Al′C4/2014 PETROCHEM ALC4/2015 and Rc_indcxcd
PRIVATE LIMITED 15 04 2015
176 HQ Filc
RLA 「ile
Lic No/Datc10510392082 Dcrcr
:01/82/050/01125/Aヽ415/1:05/24/040/00353/AM15/120112014
‐Date:20052015
I)ccision : lt was decided to defer the casc for 20.05.2015 for comments of Dcpartment of
C&PC.
Casc No.:123ノ13/82- Party Nailnc:PAYAL Mcct No/Datc:1/82- Status:Dcrrcrcd
Al´C4/2014 PETROCHEM ALC4/2015 and Rc―
indcxcd
lPRIVATE LIMITED 15 04 2015
HQ Filc lRLA Filc Lic No/Datc:0510392087 Dcfer
:O1/82/050/01126/ANl15/ 1:0524/040/00376/AM15/120 11 2014 Date:20052015
1)ccision:It、vas dccidcd to dcrcrthc casc for 20 05 2015 for comments of Dcpartmcnt Of
C&PC
I
1177
Casc No.:269/13/82-
Al.C4/2014
1)a■y Name:SIIIこE
IVALLABH CHEMICAL
ltLA Filc
Mcct No/D・ate:1/82‐
ALC4/2015
178 HQIヽlc
15042015
Lic No/Datc:0810133875 Defer
Casc No:91/13′ 82‐
AI′C4/2014
Party Narnc:lNCHEM IMect No/Datc:1/82-
ILABORATORIES IALC4/2015
1PRIVATE LIMITED 15 04 2015
Status: Dcffcrcd
and Rc-indcxcd
1179 HQ Filc RI.A Filc Lic No/D7ate:0910061287 DefL・r
:01/82/050/0109″ AM15/:0924/040/00421AM15/21.H.2014 Date:20.05.2015
o""isi- r It ** O""iO"a to a"f"r tt " *r" f-ZO.OS:OIS fo;;omr"rts of D"p"rt ""t"f -
I lI-
____ _l I N
Fr{q
StqF/ N'F'"AL ri('j\l,lR
語欝
t、1■|■p。
軸
踪
Status: Dcfl'crcd
and llc-indcrctl
:01/82/050/01272//ヽN415/1:08/24/040/00315/Aヽ415/120112014
Date:20052015
Dccision : It was dccidcd to defer the casc for 20.05.2015 for comments of Dcpartment of
C&PC.
ICasc No.:98/13/82-
ALC4/2014
Palty Namc:AUROBINDO IMcctNo/Datc:1/82-
PHARIvIA LIMITED
IALC4/2015
■5042015
HQ Filc RLA Filc Lic No/Datc:0910061307 Dcrcr
:01/82/050/O1101/AM15/ :09/24/040/00456/AM15/ 125 11 2014 Datc:
Dccision:ln the light of written comments received from Department of Pharmaceutica s vide
their oM No 35011/597/2014P(Norms)dated 29 04 2015,■
was dedded to raufv nOrms
lunder Para 4 7 of H8P vl as per details given below or as app‖
ed by the firm′ whicheveris less:
Status:
Approvcd
180
Item of Export
Quantity
S′ No
Item of lmport
Quantity
allowed kg/kg
LAMIVUDINE
l kg
1
Activated Carbon
0100
2
'fricthyl Amine
1544
3
Methanol
0336
4
Acetone
0558
5
Sodium Borohvdridc
0480
6
Toluene
239
7
Hcxamcthyldヽ‖Я7Я nC(
HMDS)
1689
8
Methanesulfonic Acid
0020
9
Methylene Chloridc
6535
10
Cytosine
0955
11
Dimethylformamide
075
12
Glyoxalic Acid(50%)
1738
13
2,5-Di hydroxyl,4-
Dithainc
0739
14
[]exanes
3046
Salicylic′ ヽcid
0832
´
０
Steam/Thermal Coal (Non-
Cooking)
As per fuel
Policy
181
ICasc No.:93/13/82-
Al.C4/2014
Party Name:HETERO
DRUGS LIMITED
‐Mcct No/Datc:1/82-
ALC4/2015
15042015
Status: I)cffcrcd
and llc-indcxcd
RLA Filc
ILic No/Datc10910061299 DcFcr
:01/82/050/01096/AM15/ :09/24/040/004681ヽ
M15/ 125 112014
Datc:20052015
| ‐Dccision:It was dccided to dcFcrthc casc FOr 20 05 2015 for commcnts of Dcpartmcnt or
l lPharmaceuticals
Casc No.:94/13ノ82- Pa“ y Namc:HETERO Mcct No/Datc:1/82- Status:Dcrrcrcd
ALC4/2014 DRUGS LIMITED ALC4/2015 and Rc― indcxcd
15042015 ‐
1田2■
。由ぉ kLA Rお
jcNυ
Dttα 091006 B00 Dctr
l 101/82/050/01097AM 15/1:09つ
4Ю40Ю0469んへM15/25H2014 1Datc:20052015
' iDccision:It was dccidcd to dcFcr thc casc for 20.05.2015 for commcnts oF Dcpartmcnt of
HQ Filc
' iり
CCISIOn:lt w^OCCl●
じO t0 0CICr inc c^じ
lor`v.υ p.zυ :D IOr COmmcnls ol
υ cp狐Imcni oI
―
―
― ―
―
―
fぃ
キ
a
l'harrnaccuticals.
Casc No:95/13/82- 1)arty Namc:HETERO Meet No/Date:1/82- IStatus:Dcrrcrcd
Al′C4/2014 LABS LIMITED IALC4/2015 and Rc―
indcxcd
115042015 ‐
183 HQ Filc RLA Filc lLic No/Date:0910061301 1Defer
:01/82/050/01098/′ ヽN415/ :09/24/040/00465/AM15/125112014 11)ate:20052015
1)ccision: lt、vas dccidcd to dcrcrthc casc fOr 20 05 2015 for commcnts OfDcparimcnt O「
I〕harinaccuticals
Casc No.:96/13/82-
Al′C4/2014
Party Namc■IETERO
LABS LIMITED
Mcct No/Datc:1/82‐ Status:Dc■brcd
.ALC4/2015 and llc― indcxcd
15042015
184 HQ Filc RLA Filc Lic No/Date:0910061302‐
Defer
:01/82/050/01099/′ ヽヽ415/ :09/24/040/00466/AM15/.25112014 ‐Datc:20052015
I)ccision : It was dccided to dclcr the case lor 20.05.201 5 for comments of Department of
Pharmacculicals.
Casc No.:99/13/82-
‐
Al′C4/2014
Party NamcllETERO Meet No/Datc:1/82-
IDItUGS LIヽ41TED IALC4/2015
■5042015
Slrtus: Dcffcrcd
and llc-indcxcd
HQl■IC IヽLA Filc Lic No/Date:0910061318 Defer
101/82/050/01102//ヽN415/ 1:09/24/040/00472//ヽM15/126 11 2014 Date:20052015
Dccision : lt was dccided to defer the case for 20.05.2015 for commcnts of Department of
Pharmaccuticals.
Casc No.:100ノ13/82-
AlンC4/2014
186 HQ Filc
Party Name:HETEIiO Meet No/Date :1/82-
I´ABS LIMITED IALC4/2015
15042015
Status: I)clfcrcd
and llc-indcrcd
RI´ A Filc l icやヾ。,Datc:0910061319 1)citr
:01/82/050/01103/Aヽ415/ :09/24/040/00473/Aヽ415/ 126112014
IDate:20052015
Dccision : It ,yas dccidcd to defer the case for 20.05.2015 for comments of Department of
Pharmaccuticals.
Casc No.:102/13/82- I)arty Namc:DR Mcct No/Datc:1/82‐ Status:Dcfrcrcd
AI,C4/2014 REDDYS IALC4/2015 ●nd Rc― indcxcd
LA30RATORIES
■5042015 1
LIMITED
187 HQ Filc RLA F‖
c Lic No7Date:0910061336 1Dcfer
:01/82/050/01105/AM15/ :09/24/040/00487/AM15/104 12 2014 1Datc120 05 2015
Dccision : It was dccided to defcr thc case for 20.05.2015 for comments of Department of
Pharmaceuticals.
一
８
Casc No.:280/13/82‐
AI.C4/2014
P7arty Namc:HETERO
LABS LIヽ41TED
HQ rilc
RI´ ンヽF‖ c
⌒ 101/82/050/01283/AM15/1:0924/040/00498/AN415/ 09 12 2014 Datc:20052015 1)ccision:It was dccidcd to dcrcrthe casc fOr 20 05 2015 for cOmmcnts OfI)cpartmcnt Of ‐Phannaccuticals Casc No.:281/13/82- ALC4/2014 ILABS LIMITED 1891責Q File~~~｀
照Ettittξ
Pa“y Namc:HETERO Mcct No/Datc:1/82-
‐ALC4/2015
15042015
Status: I)cffcrcd
and llc-indc\cd
Lic No/Datc:0910061365 Dcたr
:O1/82/050/01284/AM15/1:09/24/040/004991ヽM15/ 09122014
Datc120 05 2015
Dccision : [t was dccided to deler the case lor 20.05.2015 for comments of Dcpartment of
Pharmaceuticals.
Casc No.:282113/{12- Party Name:HETEIIO Mect No/Date: I /lt2-
Status: l)effcrcd
‐A LC4/2014 ‐LABS LIMITED ALC4/2015 and Rc indcxcd
15042015
1901HQ Filc RLA Filc Lic No/Datc:0910061366‐ Dcrc・r
:01/82/050/01285//ヽM15/1:09/24/040/00505Aヽ415/ 09 12 2014 Date120 05 2015
1)ccisiOn:It was dccidcd to dcFcr the casc for 20 05 20 15 rOr commcnts Of Dcpartillcnt()f
Pharmaccuticals
Casc N。.:283/13/82-
A:′C4/2014
Parly Na:nc:HETERO
LABS LIMITED
Mcct No/Datcl1/82‐
ALC4/2015
15042015
Strlus: I)cl'l'crcd
and lic-indrrcd
19「HQ Filc RLA Filc Lic No Datc:0910061367 Dcrcr
‐ :O1/82/050/01286/AM15/ .:09/24/040/00501/AM15/ 109 12 2014 Datc:20052015
1Dccision:1l was dccidcd to dcfcr thc case for 20 05 2015 for cOmmcnts Of Dcpartilncnt Of
‐
IPhanllaccuticals
Casc No.:279/13/82- Party Namc:HONOUR
ALC4/2014 LAB LIMITED
N4cct No/Datc:1/82-
ALC4/2015
15042015
Status: l)cffcrcd
and llc-indcrcd
1921HQ Filc ‐RLA Filc ‐Lic No/Datc:09100613621Dctr
:01/82/050Ю 1282/AMi5/:0924/0407005107AM 15/09122014
‐Datc:20052015
11)ccislon:It was dccidcd tO dcrcrthe casc ror 20 05 2015 for colnmcnts Of Dcpartmcnt or
‐
IPharmaccuticals
ICasc No.:284/13/82- Party Namc:HONOUR Mcct No/Datc:1/82- status:Dcffcrcd.
IALC4/2014 LAB LIMITED ALC4/2015 and Rc― indcxcd.
115042015 1 ‐
lHQ Filc RLA Filc Lic No/Datc:091006i372 Dcrcr
Ю1/82/050Ю 1287/AM15/:09/24/040/00509ハM15/12 12 2014 Datα
20 05 2015
Dccision : It was dccided to defcr the case lor 20.05.2015 for comments of Dcparlmcnt ol
Pharmaceuticals.
（
ソ
Pally Namc:VIJAYASRI
ORGANICS LTD
Mcct No/Datc■/82-
IALC4/2015
15042015
ICasc No.:26/1/82_
1941ALC4/2015
Sta tus: l)cffcrcd
HQF‖c ltLA Filc Lic No/Datc:0910061385 Defcr i
Ю1/82/050/01552/AM15/Ю9/24/040/00444AM 15/12122014 ‐
Datα 20 05 20151
1)ccision: lt、vas dccided to dcferthc case for 20 05 2015 for comments of Depanmcnt Of
‐
Pharmaccuticals.
」
Casc No.:27/1/82- Party Namc:VIJAYASRI IMcct No/Datc:1/82- Status:Dorrcrcd l
A LC4/2015 0RGANICS LTD IALC4/2015 and Rc―
indcxcd l
115042015 1 1
195 HQ Filc RLA Fnc Lic No′ Datc:0910061386 Dcたr i
:01/82/050/01553/AM15/.:09/24/040/00443//ヽM15/112 12 2014 Datc:20052015
1)ccision: It、vas dccided to dcrerthc casc for 20 05 2015「
or commcnts of Dcparti1lcnt of ‐
― -1
Party lMCet No/Datc:1/82-
Namc:JAGSONPAL ‐ALC4/2015
PHAlせヽ4ACEUTICALS 15 04 2015
LTD
HQ F‖c RLA Filc Lic No/Datc:0510392649 Dercr
:01/82/050/00003/AM16/ .:05′ 23/040/00450/AM15/101 01 2015 Datc:200520151
l)ccision : It was dccided to dcfer the casc for 20.05.2015 for commcnts ofDepaltmcnt of
l)harmaccuticals.
1)hal H:accuticals
‐
Casc No.:3ノ1/82-
AI´C4/2015
Casc No.::4/1/82-
Al′C4/20:5
Party Name:ANUH
PHARMA LTD
Mcct No/Datc:1/82‐
ALC4/2015
‐15042015
Status: Dcffcred
and llc-indcxcd
197 HQ「ilC IRI´ AF‖ c Lic No/Datc:0310793308 Dctr
:O1/82/050/00014/AIヽ416/ :03/94/040/00985ノAM15/ 27 01 2015 Datc:20052015
1)ccision:It was dccidcd lo dcfcrthe casc for 20 05 2015 for commcnts of Departmcnt of
‐
I)harmaceulicals.
cascヽも
.:2'i′82‐ ':“ yN:ふι
:もヽ
iё HЁM IMきまヽレbiti1/を
'l isi」
liζ人|1島|ご
|
・ALC4/2015 LABORATORIES IALC4/2015 1 '
ILIMITED 15 04 2015
HQ Filc RLA Fne lLic No/Datc1031079338 1Defer Datc:
:01/82/050/00002/AM16 :0395/040/00884/AM15 14
/ / 29012015
19
8
1)ccision:In thc light o「、vritcn commcnts rcccivcd from Dcpartmcnt of Pharmaccuticals vide
thcir OM No 350H/487/2014-PI(Norms)dated 06 02 2015,it was dccidcd to raj"nOrms
tlndcr Para 4 7 ofHBP vl as pcr dctails givcn belo、v or as applicd by the rl11:1,whichcvcr is lcss:
Item of Export
Quantity
S,No
Item of lmport
quantity
allowed
CLOPIDOGREL 75MG
TABLET
l kg
1
Clopidogrcl Hydrogcn
sulphate
99 8146 mg
鍼醐
⌒
Stalus: Dcffered
and Rc-indcxcd
J
196
may take appropriate action as per the decision of Norms Committee.
l iCasc No.:13/1/82-
IMcaNo/Datc:1/82- sぬtu゛Dcfrcrcd
IALC4/2015 REMEDIES LIMITED ALC4/2015 and Rc―
indcxcd
15042015
199 HQ File RLA Filc Lic No/Datc:0310793672 Dcfcr l
:01/82/050/00013/Aヽ416/ :03/94/040/01049/Aヽ415/ 106 02 2015 Datc:200520151
Decision : It was decided to defcr the case for 20.05.2015 for commenls of Departmenl of
Pharmaceuticals.
Casc No:7/1/82-
‐ALC4/2015
IPary NamclBDR IMect No/Datcl1/82- status:Dcrrcrcd
lPHARMACEUTICALS IALC4/2015 and Rc indcxcd
INTERNAT10NAL i5 04 2015
2001。血` PV・
LTD I
RLA File lLic No/Date:0310793727 Dcfcr
101/82/050/00007/AM16/ :03/94/040/009711ヽM15/109022015
Datc:20052015
Export Product
Export Qty.
SI No
Import item
Qty
A lowed
Kg/kg
NITAZOXANIDE
l Kg
1
2‐AMINO-5-NITRO
THIAZOLE
059
Dccision : It was dccided to defe. the case foi ZO.OS.ZO t S lor comments of Dcparrment of
Phannaccuticals.
ICasc No.:12ノ1/82‐ Pany Namc:INDOCO IMcct No/Datc:1/82- Status:DcFrcrcd
‐ IALC4/2015 1REMEDIES LIMITED :ALC4/2015 and Rc―
indcxcd‐
15042015
201 HQ Filc RLA Filc Lic.No/Datc:0310793729 Dcfc・
r
101/82/050/00012/AM16/ :03/94/040/O1005/AM15/ .09 02 2015 Datc:20052015
:Dccision:It was dccidcd to dcrcrthc casc for 20 05 2015 for cOmmcnts OfDcpartmcnt Or
‐
| ,Pha:l‖ accuticals
iCasc No.:10/1/82‐ :Pa“y Namc:ENALTEC Mcct No/Date:1/82‐ status:
IALC4/2015 1LABS PVT LTD ALC4/2015 Approvcd
15042015
1HQ Filc lRLA Filc Lic No/Datc:0310793947 Dcrt‐ r Datc:
|:01/82/050/00010/AM16/ :03/94/040/01082/AM15/ 18022015
IDccision:In thc light Of writtcn cominlcnts rcccivcd rlo!n Dcpaninncnt Or Pharillaccuticals vidc
thcir oM No. 3501l/621/2014-Pl(Norms) dated 29.04.2015, it was decidcd to ratify nonns undcr
202 Para4.7 of IIBP vl as per details given bclow or as applicd by the firrn, whicheverls lcss:
ICasc No.:11/1/82-
IALC4/20:5
2031
Party NalllclNDOCO
REMEDIES LIMITED
ヽ4cct No/Datc:1/82-
:ALC4つ015
115042015
:Lic No′1)atc:0310793939
Status: I)effcrcd
and llc-indcxcd
IHQ File
RLA Filc
I)cncr
:01/82/050/00011//ヽM16/ :03/94/040/01070/ノ｀Mi5/ 118 02 2015 1Datc:200520151
1)ccヽlon:h was dccidcd to deferthc casc for 20 05 2015 for commcnts ofDcpartmcnt of l
Pharmaccuticals
Casc No.:8/1782- Party Nainc:BDR Meet No/Datc:1/82‐
Status:Dcrfcrcd
Al′C4/2015 PIIARMACEUTICALS ALC4/2015 and Rc― indcxcd l
l INTERNATIONAL 15 04 2015
PVT LTD
204 HQ Filさ Rし
AFilc Llci｀o/Dtte10310ケリ398715ごおr
:01/82/050/00008/AM16/:03/94/040/00917/AM15/19 02 2015 Datc120 05 2015
1)ccision: It、vas dccidcd to dcfcrthc casc ror 20 05 2015 for commcnts of Dcpartmcnt of
Pharmaccuticals
Casc No.:4/1/82-
AI´C4/2015
205110118 ‐
☆LArilt ~ Litiヽも
,DatciOなibib′
``う
lb:ヽF ~ 1
:01/82/050/00004/AM16/Ю 8/24/040/00436/AM15/'5 02 2015 Datc20 05 20151
1Dccision:■wasdccidedlodeferthccasefor20052015forcomlncntsofDcpanmcntOf i
C&PC I
Casc No.:1/1/82_ Party
Al.C4/2015 Name:PARAMOUNT
‐ IAROMACHEM
PVT LTD,
‐
lヽ4cct No/Dac:1/82- IStatus:I)crrc・rcd l
ALC4/2015 and itc indc、cd
15042015
206 uq fi|"
RLA Filc
Lic.No/Date:05103933 85 Dclcr
:01/82/050/00001/A Ml6/ :05/241040/00563/AM l5/ 26.02.2015
Datc:20.05.2015
Dc lcr
Dccision : It was decided to defer the case for 20.05.2015 for comments of Department of
i
C&PC.
Pa■y Name:MICRO Meet No/Datc:1/82- Status:Dcrhrcd
l′ABS LTD ALC4/2015 and itc― indcxcd
15042015
207.HQ File ‐RLA Filc Lic No/Datc10710107776 1DcFcr
101/82/050/00006/AN116/ :07/24/040/00446/AM15/ 10 03 2015 1Datc:20052015
Dccision:It、vas dccided to deferthc casc for 20 05 2015 for commcnts of Dcpanrncnt of
Pharmaceuticals
Casc No.:6/1/82-
IAl,C4/2015
Casc No.:15/1/82-
Al´C4/2015
Parly lMCCt No/Datc■/82‐
Nalnc:ALCHYMARS ALC4/2015
'lCM SM PRMTE
;1s.04.2015
lluraneo _
_i
HQ Filc
RLA Filc
:O1/82/050/00015/′ ヽヽ416/ :04/24/040/00272//ヽM15/ 11 032015
IDatc:20052015
l)ccision : lt was dccided 1o defcr thc case for 20.05.2015 for commcnts of Dcpaflment ol
Pharmaceuticals.
……
D,pi
MバR
TI勇。
‐
`de
傲競彙盤百
e
⌒
Casc No.:16/1/82‐
:ALC4/2015
2091HQ Filc
Casc No:17ノ1/82_
AI′C4/2015
HQ Filc
Party Namc:HETERO
LABS LlMITED
RLA Filc
‐Mcct No/Datc:1/82-
IALC4/2015
115042015
Sta (us: Dcffcrcd
and llc-indcxcd
:01/82/050/01542/AM15/ :09/24/040/00703/Aヽ
415/ 17032015
Dccision : It was decided to dcfer the case fo r 20.05.2015
Pharmaceuticals.
Lic No/Datc:09100617161)ofcr
Date:20052015
for comments of Departmcnt of
|ヽ4cct No/Datc:1/82- Status:
‐ALC4/2015 1Approvcd
15042015
Lic No Datc:22100152 Dctr Datc:
15
18032015
in ts 8/82 meeung datOd 25 09 2014′
“
as per detais given below or as applied
Pary Name:SAURAV
ICHEMICALS LTD,
RLA Filc
:01/82/050/01543/AM15/ :22′ 24/040/00107 AM15/
.Dccision:in the Hght of earlier decision taken by NC
IWaS dedded to raJfy norms under Para 4 7 of HBP vl
210 ‐
by the firm′ whicheveris less:
Export product
Exp
Qty
SI No
lmport items
Qty. allowed (kgl
DEXKETOPROFEN
TROMETAMOL
l kg
1
KETOPROFEN
178
2
N-OCTYL‐ D‐
GLUCAMINE
036
3
TROMEIIIAMINE
036
ICasc No.:18/1/82-
ALC4/2015
Party Namc:DHANUKA
LABORATORIES LTD
|
Mcct No/Date:1/82-
ALC4/2015
15042015
Status:
A p p rovrd
1責0 1ilさ 1良LA lilc tiしヽ
Io/Datc:0510393648 Dcrcr Datc:
101/82/050/01544/AM15/ :05/23/040/00547/AM15/ 19032015
I)ccision :In the Iight of written commcnts reccivcd from Dcpanmcnt of Phamaccuticals vidc
thcir OM No. 3501 l/349/2014-PI(Norms) datcd 28.11.2014, it was dccidcd to ratit-y rhc norms
undcr Para 4.7 ofHBP vl as per details given bclow or as applied by thc lim, rvhichcvcr is lcss:
Export Product
Expon
Quantity
S No
lmport Item
Qty Allowed
kノkg
CEFIXIME USP
/BP/1P/EP
Powder
l kg
l
7-AVCA(7-Amino‐ 3-
Vinyl―Ccphalosporanic
Acid)
0571
Dimcthyl Acetarnide
165
MICA Estcr
082
4
Ethyl Acetate
095
つ
‘
＾
２
5
Methylcne Chloride
384
IIA may takc appropriate action as pcr the dccision of Norms Committcc.
Casc No.:20/l/tl2-
Party Namc:CADILA Meet No/Date:1/82- Status:Dcffcrcd
Al,C4t2(115
FIEALTHCARE LTD., ALC412015
and Ilc-indcxcd
15.04.2015
IIQ File
I{LA File
Lic.No/Datc:08101i4879 Defcr
:01182/050/01546/AMl5l :08/241040100474/AMl51 23.03.2015
Date:20.05.2015
l)ccision : lt was dccidcd ro dcfer thc casc for 20.05.2015 for comments ofDeparlment of
I)hanraccuticals.
HQ Filc RLA Filc Lic No/Date:0910061740 1Dcrcr Date:
:01/82/050/O1547/Aヽ415/ :09/24/040/00683/AM15/ 123032015 ‐
1)●cision : In the light of carlier dccision taken in meeting no 18/82 dated 18 02 2015, it、
vas
劉3躍
憮
絆
i:1∬
m“ r hm 47 JHBP」
ぉ
"r dctalls ttn ttOW∝
as ap"“
け
市C
Export
product
Export
Qty
SI No
Import items
Qty. allowed
onistat
Pclcts 5000
l kg
Orlistat
0505/kg
I{A may takc appropriate action as pcr the decision of Norms commiltec
1214
l)ccision : It was decided to dcfer the case for 20.05.2015 for commenls of Department of
Pharmaceuticals.
Casc No:23/1/82- Party Namc:SMS MCCt No/Date:1/82-
:ヽ1´C4/2015
HQ Filc RLA Filc Lic No/Datc:0910061762 DeFcr
:01/82/050/01549/AM15/1:09/24/040/00579/AM15/124 03 2015 1Date:`
う
ι
HQ Filc
I Casc No.:21/1′ 82‐
やany Name:DISTO IMeet No/Datc:1/82- Status:
AI′C4/2015 PHARMACEUTICALS ALC4/2015 1Approvcd
IPRIVATE LIMITED 15 04 2015 1
216(〕asc No:5/1/82- Party NanlcilNllCRO ヽ4cct No/Datc■
'82- Statusil)cfft・
rcd
■ ,■1 = || | 1 1___ _ _‐ = ~~~
■14 /｀、^ ヽi ._‐ ′
1′ 0つ I)、,1、.ヽ10,、、_ヽイir｀1,∩ 、4`ヽ′ヽ1ヽJ∩ア
Iヽ
`、
i`ヽ 1,Rつ_ S,nil,、:1)ρ r戯、
!`、fl
JF1lM軍1尋ギ響
1等響
:ギ警
iすIIャ響Ψ
翻師"f抑
口。■由‐1●■1警:蚊
u:寅聾編占
rヽ騎3し,“
|
Casc No.:22/1/82- Party Namc:HETERO Meet No Date:1/82-
Al′C4/2015 LABS LIMITED IALC4/2015
115042015
Status:Deffcrcd
and ltc-indcxctl
No.:32/1/82-
Party Name:DIVIS
Mcct No/Datc:1/82-
LABORATORIES LTD,IALC4/2015
15042015
Itc― indc、
t・d
I{c-ind crctl
HQ File
:O1/82/050/01558/AM15/
AM15/31032015
: lt was decidcd to defer lhc casc for 20.05.2015 for comments of Departtncnt oF
I'arty Narnc:l)IVIS
Mcct No/Datc:1/82-
LABORATORIES LTD, ALC4/2015
15042015
1/82/050/01559/AM15/
′
Aヽ415/ 31032015
It was decidcd to defer the case for 20.05.2015 for comments ofDepartment of
Datc:13042015
Placc:Ncw Dclhi
(,::sc No.:33/1/82-
A LC4/2015
鶉
鮮
ヽ
‐ALC4/2015
1HQ Filc
:01/82/050/00005/AM16/
IDccislon:It was decidcd
and Re-indcxcd
LABS LTD
IALC4/2015
115042015
RLA Filc
Lic No/Date:0710107918 Dcたr
:07/24/040/00457/AM15/ 125032015
Datc:20052015
to deler the case for 20.05.2015 lor commcnts of Dcpartmcnt of
iCasc No.:28/1/82- Pa●y Namc:DHANUKA IMcctNo/Datc:1/82- Status:Dcrrcrcd
lALC4/2015 LA30RATORIES LTD IALC4/2015 and Rc―
indcxcd
115042015
217 HQ Filc RLA Filc Lic No/Datc:05103937451)cたr
. |:01/82/050/01554/AM15/:0523Ю 40/00556/AM15/26032015
【)atc:20052015
i E;t.t"" '. It ** d""td"d t" defer the case for 20.05.2015 for comments of Department of
;
Pharmaceuticals.
Party Namc:HETERO Mcct No/Datc:1/82-
LABS LIヽ41TED
ALC4/2015
115042015
2181HQ F‖c lRLA File Lic No/Date:0910061790 Dctr l
:O1/82/050701556/AM15/ :09/24/040/007131ヽ
M15/ 130 03 2015 Datc:200520151
1Dccision:It was dccidcd to dcfcrthc casc for 20 05 2015 for comments ofDcpartmcnt of
l :Pharinaccuticals
Casc No.:30/:/82-
ALC4/2015
Strtus: l)cllcrcd
and llc-in(lc\cd
‐ ICasc No.:29/1ノ82-
IALC4/2015
Ptty Namc:HONOUR
LAB LIMITED
Strtus: I)cl li'rod
r ntl Rc-inrlcrcd
IMcct No/Datcl1/82-
IALC4/2015
115042015
RLA F‖c ,Lic No/Datc:0910061789 Dcrcr
:09/24/040/00722/AM15/ 130 03 2015 Datc:20052015
dcler the case for 20.05.2015 lbr commcnts of Dcpartmcnt of
2191HQ Filc
:O1/82/050/01555/AM15/
l)ccision : It was decided to
Pharmaceuticals.
Pany Name:VIVIMED :Mect No/Datc:1/82-
LABS(ALATHUR) IALC4/2015
PRIVATE LIMITED 15 04 2015
2201HQ Filc RLA File Lic No/Datc:0410160364 Dcたr
l :01/82/050/00009/AM16/ :04/24/040/00292/AM15/130 03 2015 Datc:20052015‐
Dccision: It、vas dccidcd to dcFcrthc casc ror 20 05 2015 1or commcnts or Dcpartincnt of
Pharinaccuticals
‐Mcct No/Datc:1/82‐
Casc No.:9/1/82-
A LC4/2015
Status:Dcffcrcd
and llc-indr:xed
ICasc No.:31/1/82‐ Party
Status: l)cl fcrcd
and llc-indcrcd
つ
ι
う
る
ALC4/2015
Nme:AUROBINDO ALC4/2015
PHARMA LIMITED 15 04 2015
IHQ Filc RLA Filc Lic No/Datc:0910061820 Dcrcr
Ю1/82/050Ю 1557/AM15/:09/24/040/00707/AM15/31032015 1)atc 20 05 2015
1Dccision:It was dccidcd to dcfcrthc case for 20 05 2015 for commcnts ofDcpartmcnt or
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