DGFT Committee Minutes
Oflice of Directorate General of Foreign Trade New Delhi -
Para 4.7 Decision(DRAFT)
MEETINGNUMBER :2/82-ALC4I20ISMEETINGDATE :29.04.2015
But actuaf ly held on21.05.2015
Meeting No. 2182 of 2014-15, to consider the cases/issues under Duty Exemption
Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 perlaining to Chemical and Allied
products and falling under Chapter 29 and 30, was scheduled fot 29.04.2015 but actually
held on 21.05.2015 under the Chairmanship of Shri Jaikant Singh, Addl. DGFT in Room
No.11, Udyog Bhawan, New Delhi.
Following members were present:-
Shri Nirmal Kumar, Deputy Director General of Foreign Trade
Dr. Nitin Jain, Scientist 'D', Department of Biotechnology
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. 1/82 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 took the decision as
mentioned against each case.
IALC4/2014
1■3児5υ0079ダAMly
LIFE SCIENCES PRIVATE IALC4/2015
Status:
Deferred
Defer
Date:
25.06.2015
LIMITED,
RLA Filc
P9042015
面
I雨謳百o41009435'
:04/24/040/00395/AM08/ 12032008
Decision : It was decided to request the firm to fumish Production and Consumption data
duty certified by Central Excise Authority. The case is defened for29.04.2015.
iCase No.:14/24/82‐ Party Name:SAINOR Meet No/Datc:2/82-
IALC4/2010 LA30RATORIES PVT IALC4/2015
「
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Decision : It was decided to defer the case for 25.06.2015 for comments of Department of
Pharmaceuticals.
Case No.:28/28/82‐
ALC4/2012 Party Name:MYLAN LABORATORIES ヘ ~ RLA RL Lic No′lDate:0910053660 :01/82/050/00995/AM13/ :09/24/040/00270/AM13/ 04092012 : Withdrawn as the case was already rejected by the NC in its l8/82 meeting dated 18022015 一 ― 一 ― LABORATORIES PVT LTD Meet No/Datc:2/82- ALC4/2015 29042015 厩扇蘊蔦戸膨鵬υ∞ 4蕊蔦戸 | : Withdrawn as the case was already rejected by the NC in its l8/82 meeting dated 18022015
Case No.:16/3/8多
ALC3/2013 18022015 Meet No/Datc12/82- ALC4/2015 29042015 : Withdrawn as the case was already rejected by the NC in its l8/82 meeting dated : It was decided to defer the case for 12.06.2015 for comments of Department of Ipp. Partv Name:GLAND mate:2/82- 1錯″盤∵ PHARMA LIMITED : It was decided to defer the case for 25.06.2015 for comments of Department of
Case No.:4/27/82‐
Status: Rejected 覇囲F薦~饉 蔽I B憩2‐劉 5
Case No.:42/20/82-
ALC4/2013
Case No.:68/17/82-
ALC4/2013 : It was decided to defer the case for 12.06.2015 for comments of Department of AM13/ F33児 50/01028/AM14/ ¨ =― ― 一―― lDefer 響 嘘″ “ 0/00剛AM Ⅳ 「■ “ 2釧3 1鶏 知 5 Re-indexed
1需
N帥oMCЮ 鳳
::
l p9.042015
1鷺ち糀OЮm HハⅢ″
Re-indexed
「田酉
ド繹RI穆ル師
Dtte:12062015
: was decided to defer the case for 12.06.201 5 for comments of Department of
Pc続
oB PRGANICSⅣ
■LTD,1翼
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r_ __ _ : |
D;i"ioo ,-1fiu. d""ided 6 .":."t tt " "^" * . nr fru. not n -itt "O
information despite
repeated reminders.
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ICALS PVT LTD
F]:]こ3万51晨F551o75484
8
22102013
驚
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:03/95/040/00575/AM14/
No.:31/4/82‐
No/Datc:2/82-
5
Re-indexed
15
AM15/
55/AM14/31072013
12062015
Ee"i.i", , ft lr* d""td"d t" d"ib. th" "u"" fot t2.06.2011 fo, .oi.gtt:f D:!*i""lf9{I9
No.:9/30/83‐
Re-indexed
一
Ｆ
扁1
隔源
4/
: It was decided to defer the case for 12.06.2015 for comments of Department
No.:22/17/82‐
Name:ATHENA
No/Date:2/82-
DELIVERY
Re-indexed
PRIVATE
:it was decidcd tO defcrthe casc for 12 06 2015 for comments of Department of
い
Ｆ
;Lffi:.:*,*o to,"jA the.a.e "s @ [壁ジ 1濶ル ぶ総誕 :ddedゎ崎。∝品 cぉe as the■mhぉnd imおhd hぉm面。ボロ“ liぢilデ:デ言浩 it卜1:‖il薦of Department ofC&pC. NO/Date:2/82- 15 Re-indexed 12062015 Date: No.:28/24/82- 郷 38帰50/01227/AMI″ 隔蒻顧薦ζttTI竹#』TЮ 910058239 鷲::滉讐ぶ漁113としdb呵耐I:凛1朧 'iLilIXl.鍋 cd hぉ品liふ「d“ ・ ic 1辮戸 藤
LIMITED '9042015
: lt was decided to defer the case for 12.06.2015 for comments of Department ofC&PC.
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ision : In the light of earlier decision taken in meeting no.23182 dated 01.11.2012, it
r decided to ratify norms under Para 4.7 of HBP vl as per details given below or as
lied by the firm, whichever is less:
Export product
Exp
Qtv
SI No
lmport items
Qtv.
allowed
Calcium Gluconate-
lnjectable Grade USP
l kg
1
Calcium Gluconate (Oral Grade)
1 05kg
Calcium Boro Gluconate
l kq
1
Calcium Gluconate (Oral Grade)
0 946 kq
Calc um Glubionate
l kq
1
Calcium Gluconate (Oral Grade)
0 430 kq
may take appropriate action as per the decision of Norms Committee.
Status:Deffered
函高而It was dcctted to defcrthcあ面
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需
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一
4/ 102012014
No.:204/3/82‐
Namc:VIVIMED
No/Datci2/82-
LIMITED
Re-indexed
lDetisi。.:Itwasdecidedtodeferthecascfor12062015forcommentsofDepmmeliofC&Pc
No.:208/3/82-
File lLic No/Datc:0910059017
1/82/050/00212/Alヽ415/
Namc:VIVIMED
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No.:87/3/82-
LIMITED
Re-indexed
| 1蹴1206知5 Decision : lt was decided to defer the case for 12.06.2015 for comments of Department ofC&PC.
Case No:117/3/82-
Partv Name:VIVIMED Mcct No/Datc:2/82- Status:Deffered ALC4/2014 LABS LIMITED ALC4/2015 Re-indexed 29042015 12062015 : It was decided to defer the case for 12.06.2015 for comments of Department of C&PC. Rejected : It was decided to reject the case as the firm has not fumished information despite reminders. Mcct No/Datc12/82- ALC4/2015 29042015 10059289 Defer Date: :01/82/050/00135/AM15/ :09/24/040/00576/AM14/ l14022014 062015 : It was decided to defer the case for 25.06.2015 for comments of Department of Re-indexed 12062015 : It was decided to defer the case for I 2.06.201 5 for comments of Department of C&PC. F‖ e No.:118/6/82- 4/2014 No/Date:2/82- 4/2015 Rejected 29042015 Lic No/Date:0910059155 04022014 Casc No.:73/3/82- ALC4/2014 27 HQ Πに ァ彫蔦/∞ "6ハ扁囲鼎“Я∞ "25 :01/82/050/00077/AMll Mcct No/Datc:2/82- Ｆ ‐ ‐ ‐ ‐ ‐ ２ ８ ‐ ‐ ‐ ‐ ， 29 F蕊 評 戸~臨 蔀蕊 万~陣 ea Noわたν "― 口MrED ‖ 9.“盤∵ 1難湘鮒∬ UM諄謝r納― 器星鷺 5υ∞")AMy脇糀υ∞創″AMWI翔鼎 : It was decided to reject the case as the firm has not fumished information despite reminders.
Case No.:131/3/82‐
ALC4/2014 Partv Name:ASTRIX LABORATORIES LTD, Status: Deffered 「F鱚=[驚響総駅 042015 Re-indexed 56 Name:ARENE SCIENCES
Case No.:106/3/82‐ Party NamcPERFECT IMcct No7Date2/82- IStatusDeffered
.ALC4/2014 ‐VITAMINS PVT LTD IALC4/2015 and Re‐ indexed
l :29042015
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3itO defcrthc casc for 12 06 2015 for comments ofDepartrnent ofC&PC
「
Party Namc:PE
: It was decided to defer the case for 29.04.2015 for comments of Depanment of C&PC.
Re-indexed
: It was decided to defer the case for 12.06.2015 for comments ofDepartment of
Case No.:51/3/82‐
ALC4/2014
Case No.:33/10/82‐
ALC4/2014 Ptt NamcSMLAX~図 電頭層 面元 「 ~~ Re-indexed : lt was decided to defer the case for 12.06.201 5 for comments of Department of
Case No.:57/3/82-
ALC4/2014
LIFE SCIENCES
LIMITED
Status:Deffered
and Re-indexed
35日
圃
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15: 「 「モ
「
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7テ5 [ 「
[:i:i::i:::ii:::i;i::~|
: It was decided to defer the case for 12.06.2015 for comments of Department of C&PC.
: It was decided to defer the case for 12.06.2015 for comments ofDepartment ofC&PC.
36
Mcct NoノlDatc:2/82-
1鱚
隔蕊扁囲鶉蔦明
扇
0039601臨蕊
4/ 112032014
7/AM14/ 13032014
No.:48/15/82-
Namc:SATYA
^ | :0 r /rzroso/o r :ivarvr r v W tr4 t o4u 0064 q Alr:Utt [tfi 20 I 4 12062015 :It was decided to deferthe case for 12 06 2015 for comments of Department of No.:26/y82- 14 ALC4/2015 29042015 : It was decided to reject the case as the firm has not furnished information despite reminders.
Case No.:13/10/82‐
ALC4/2014 )ecisioll : In the light c lo 350Hκ 592014-Plo l as per details given bel )f wrinen comments received fiom Department of pharmaceuticals vide their Ol lorms) dated 18.05.2015, it was decided to ratify the norms under pam 4.7 ofHB ow or as applied by the firm, whichever is less: И Ｐ Export Product Export Quantity S No Import Item Qty A‖owed kg/kg 2-Hydroxymethyl-3- methyl-4-(2,2,2- trifluoroethoxy) pyridine hydrochloride 鰊 l kg 1 2,3 Lutidinc 0714 2 2,2,2 Trifluoroethanol 0714 3 Accdc Acid 0250 4 Hydrogen Peroxide 50% O180 5 Sulphuric Acid (CPGrade) Not an importable item. 6 Nitric Acid 70% Not an importable item. 7 Ammonica Gas Not an importable item. 8 MDC (Methyle chloride) 024 9 MIBK 016 10 Potassium carbonate powder 0420 11 TBAB 0035 つ ι Acetic anhydride 1 00 13 Sodium hydroxide 0376 開脇瓢而厩脇高蕊 4
appropriate action as per the Party Name:JINDAL 一 ４ ０ :01/82/050/00368/AMi5/Ю 3/94/040/01098/AM14/p7032014 Decision : It was decided to defer the case for 12.06.2015 for comments ofDepartment ofC&PC. :0 | I 82 I 050 I 009221 AMt s I i:09 /24 I 040 t 006 5 t I AM 1 4 I O t .O 4.20 t 4 「 RA may take appropriate action as per the decision of Norms Committee. 41 :12062015 1 : ln the light of written comments received from Department of Pharmaceuticals vide ir OM No. 3507L/647/20t4-Pl(Norms) dated May 2015, it was decided to ratify norms under 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: (2S)― (1- Tetrahydropyralnid― 2-One)‐ 3- Methylbutanoic Acid(TPA) 一 ４ ２ 甲¨ 冨… 濶納 ~ Deffered Re-indexed .Decision : It was decided to defer the case for 12.06.2015 for comments of Department of C&pC. ¨ LA薇 LABORATORIES LIMITED 1器3児50Ю0454晨Mly蕩扁蕊而贖悧辮Ю 3Ю7765貿臨 蒻 脚 i 畷 | 14 Carbon 0055 Toluene 0040 16 IPA 0038 may No.:51/y82- LIMITED 5 and Re-indexed Item of Export Qty SI No Item of lmport Quantity allowed kP./ks. l kg L―Valinc 104 2 Methylene Chloride 314 3 Iso Propyl Alcohol 104 4 Acrylonitrile 023 Ｃ Ｊ Methyl Chloroformate 084 6 Methanol 152 9
囲辮 JЮ“ %% lecision : In the light of written comments received from Department of Pharmaceuticals vide tl lo. 35011156712014-PI(Norms) dated 16.04.2015, it was decided to ratifu the norms under Para 4.7 I as per details given below or as applied by the firm, whichever is less: Export Product Export Quantity S No Import ltem Qty. Allowed ke/ks TENOFOVIR DISOPROXIL FUMARATE FROM PMPA l kg 1 TenofoYir Fumarate (TCX) II 080 2 Chloromethyl isopropyl carbonate( 13527 3 Triethyl amine Ａ Ｖ ｎ フ ０ 4 Fumaric acid 026 Cyclohexane 339 ´ ０ N‐methylo2‐ pンπolidone OMPO) 14878 7 Isopropyl alcohol 339 8 Methvlene dichloride 226 may take appropriate action as per the decision ofNorms Committee. 「
Case No.:4/10/82-
ALC4/2014 HQ Filc :01/82/050/00918/AM15/ ame:BIOLOGICAL TD their OM HBP vl aS 巨LA Flle~~~~~~~― LたNo/Datα 091005970g Detr D江o l:09/24/040/00670/AM14/p3042014 1 :ision : ln the light of written comments received from Department of Biotechnology vide l BT lL/05/382/2O13-PlD dated 26.02.20L5, it was decided to ratify norms under Para 4.7 of details given below or as applied by the firm, whichever is less: Item of Export Quantity S No Item of lmport Quantity allowed per million vials (PENTAVALENT VACCINE) FULLY LiQUlD COMBNAT10N VACCINE SINGLE DOSE VlAL, PEDIATRIC DOSE DIPHTHERIA,TETANUS PERTUSSIS,HEPATITIS B RECOMBINANT AND HAEMOPHILUS NFLUEhlZA TYPE B(HIB) COMBNED VACCINE WITH VACCNE VIAL MONITOR (VVM) Vials POLVETHYLENE CLYCOL 61XXl(MACROCOL) 76 848 kg 2 AEROSIL 380V(COLLIDAL ANH SILiCA BP) 20 375 kg 3 GLYCEROL 122 8411tr 4 TヽVEEN‐20(POLYSORBATE 20) 7 685 1tr 5 POTASSiUM THYOCYNATE 169 742 gms ´ ｂ TRIS BUFFER 10 216 kg 7 ALUMNIUM CHLORIDE 6 HYDRATE EXTRA 27 665 kg 8 YEAST EXTRACT 22 447 kg 9 DEXTROSE(CLuCOSE) 35 937 kg 10 L‐CYSTINE 0 437 kg 11 BACTO CASAMINO ACID 31 758 kg TH10MERSOL 0 379 kg 13 SiしICON EMULS10N 16 5 kg 10 1器星掲 5ν0096νAMl夕Ъち尻 iν00638ハMlイ
14 ADIPIC DIHYDRAZIDE (ADHヽ 1 686 kg Ｃ υ N‐ 3‐ DIMETHYLAMINOPROPYL‐ N‐ETHYLCARBODIMIDE HCL rEDCヽ 167 545 gm 16 2(N‐ MORPHOLINO) ETHANE SULFONIC ACID (MES) 1 441 kg 17 CETAVLON 1537 gm 18 ALUMNIUM PHOSPHATE CEL 2%(ADJU PHOS 296) 76 991 kg 19 L‐TYROSlNE 0 7841 kg 20 NZ CASE TT(CASEIN PEPTONE PLUS) 39 12 kg 21 VITハ4■ヽBI HCL (■■AMNE HYDROCHLORIDE) 1 14gm CLASS VIALS 1100000 nos 23 RUBBER STOPPERS 1095638 nos 24 ALUMINIUM CAPS′ SEALS 1088334 nos 25 HEATMARKER VACCINE VIAL MONITOR(VVM LABELS) 1086508 nos 26 SHIPPnヾG「NDICATORS(Q TAC 2PLuS) 902 nos 27 FILTERS&FIt TER AlDS 250 nos 田 : : ln the light of written comments received from Department of Biotechnology vide their OM BT/\VOS|382/2O73-P|D dated 26.02.2075, it was decided to ratify norms under Para 4.7 of HBP v1 as details given below or as applied by the firm, whichever is less: (PENTAVALENT VACCINE) FULLY LIQUID CONIBANITA10N VACCNE 10 DOSE VIAL PEDIATRIC DOSE DIPHTHERIA, TETANUS, PERTUSSIS,HEPATITIS B RECOMBINANT AND HAEMOPHlしLuS INFLUENZA TYPE B(HIB) COMBNED VACCINE WITH VACCINE VIAL MONITOR (VVM) 224 47 kg Item of Export Quantity S No Item of lmport Quantity allowed per million vials via I POLYETHVLENE CLYCOL 6000(MACROCOL) 768 48 kg 2 AEROSIL 380 V(COLLIDAL ANH SiLiCA) 203 75 kg 3 CLYCEROL 1228 411tr 4 TヽVEEN-20 (POLYSORBATE) 76 58 1tr Ｅ Ｊ POTASSIUM THYOCYNATE 1697 42 gms 6 TRIS BUFFER 102 16 kg 7 AしUMINlUM CHLORIDE 6 HYDRATE EXTRA 276 65 kg 8 YEAST EXTRACT 9 DEXTROSE(CLUCOSE) 359 37 kg 10 LCYSTNE 4 37 kg V TH10MERSOL 3 79 kg 12 ADIPIC DIHYDRAZIDE (ADH) 16 86 kg hera1 0f FO( 陽 撫 雛樵
13 N‐ 3‐ DIMETHYLAMNOPROPYL‐ N ETHYLCARBODIMIDE HCL(EDC) 1675 45 gm 14 SiLICON EMULS10N 165 00 kg Ｅ コ ■ ■ 2‐銀‐MORPHOLINO) ETHANE SULFONIC AClD (MESヽ 14 41 kg ´ ｂ CETAVLON 15 369 kg 17 ALUM:NIUM PHOSPHATE CEL 2% 769 91 kg 18 L‐TYROSINE 7 81 kg 19 NZ CASE TT(CASEIN PEPTONE PLUS) 391 2 kg 20 VITABIN BI HCL (THlAMINE HYDROCHLORIDE) 11 45 gm 21 GLASS VlALS SILCONlSED 5ML 1100000 nos 22 RUBBER STOPPERS 1085430 nos 23 ALUMiNlUM CAPS′ SEALS 1076890 nos 24 HEATMARKER VACCiNE VIAL MONITOR LABELS (VVM LABELS) 1100000 nos 25 SHIPPING INDICATORS (OTAC 2PLuS) 1790 nos 26 FlLTERS&FILTER AIDS 2500 oos 27 BACTO CASAMINO ACID 317 58 kg : It was decided to defer the case for 12.06.2015 for comments of Department of C&PC. 吻 翻 :| 陽警 :1ヽと ぶI 暉 ， ― ― ‐ ‐ ― １ ４ ８ Ｆ ‐ ‐ ‐ ‐ ‐ Rejected 47 F‖ c 10014788 I I 821 050 I 00425 I AM t 5 I :22/24 / 040/00098/AM I 4/ 09.04.20 I 4 : It was decided to reject the case as the firm has not fumished information despite reminders. No.:24/6/82- Name:KUDOS No/Date:2/82- 14 LTD, : lt was decided to re.iect the case as the firm has not furnished information despite reminders. No.:1/2/82- Party Name:CADILA Mcct No/Datc:2/82- 雨蕊鳳:薦 15 15
HEALTHCARE LTD, Lic No/Datc:0810130534 Defcr Re-indexed Datc:12062015 IDecision 11■懸dccdcd to send a copy ofapplた “ ontoDeFttmentoFPharmaceu■cJs forthdr .comments. The case is deferred for 12.06.2015. todeferthecasefor12062015for3ふmmcnts ofI)epartmcnt of lヽ4cct No/Datc:2/82- IALC4ノ2015 129042015 Re-indexed Decision : It was decided to defer the case for 12.06.2015 for comments of Department of Biotechnology Re-indexed 12062015 : In the light of written comments received from Department of Pharmaceuticals their OM No 35011/568/2014‐ PI(NollllS)dated 29 04 2015,it was dccided to call following information from the firm : I . Stepwise yield on molar basis for each step of manufacturing process. Material balance for each step. . Requirement & recovery ofsolvents at each step. . Copy ofTechnical Literature in support olyield claimed. Past production vis-d-vis actual consumption ofall imported input duly certified by Excise Authorities. casc、vas dcfcrrcd for 12 06 2015 No.:49/10/82- 4/2014 -_- -----: '--'-"- -'--' I 3ln the light of written corr"ntr ,"."ir"J fr", D"p"rt.".t of-pn.rrr."rti..f, ,ia" ‐ ５ ５ 劇 ２ ０ ‐ Ａ 」 Ｃ ４ 独 一 鵬星児 50Ю"5面百1鶴雅 OЮ∞“晨Ⅲ ]1吾蘊膏而繭躊12Ю6m5 Name:BIOLOGICAL E OM No.35011/569/2014-Pt(Norms) dated 29.04 2015, it was decided to ratify norms under 11042014 No.:34/5/82- Namc:ALEMBIC No/Datc:2/82- Re-indexed No.:21/10/82‐ File 1/82/050/00935/AM15/ 4/ 121042014 12062015 No.:48/10/82- Name:MYLAN TORIES つ ４ ０ ０ ２ ｅ ｈ ‐ ５ ５Ｍ 卿 洲 AM15テl:;ち漏liO/00650/AM14/
ra 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Qty SI No Item of lmport Quantlty allowed kg/kg FOSAMPRENAVIR CALCIUM l kg (2S,3 S)- I ,2-Epoxy-3-(Boc- amino)-4-Dhenylbutane 087 (S)― (+)‐ 3- Hvdrox■tetrahvdrofllran 034 3 4- Nitrobenzenesulfonvlchloride 0814 4 Dichloromethane/ Methylene Chloride 495 Ｅ υ Isobutylamine 130 ´ ｂ Methanol 573 7 Triethylamine 0972
Case No.:38/10/82-
ALC4/2014 ~|:ii::lili:::::こ 頂 R5 )(::;lあlll「 t'2ノ82- 29042015 田島児Ю畑%η蔦 脇 詰∽0蕊 硼 ポ 面 “ %"PttrDた s vide under f hA ,.y t"k" ,pp.pri"t" ..tlon as per the decision of Norms Committee. ,lon:ln the light of written comments received from Department of Pharmaceuticals OM No 35011/629/2014‐ Pl(Norms)dated Mav 2015′ I was decided to rajfy norms u 4 7 of HBP vl as per details given below oras applied by the firm′ whicheveris less: Item of Export Qty SI No Item of lmport QuanJty allowed kg/kg Abacavir Sulphate l kg 1 Vincelactam 250 2 Di Tert Butyl Dicarbonatc 500 3 Dimethyl Formamide 700 4 Sodium Borohydride 0946 一 ｂ N‐ (2‐Amino‐ 4,6- Dichloro Pyridinc-5-Yl) Follllarnlde 1042 6 Triethyl Ortho Formate 150 7 Tetrahvdrofuran 415 ; iiirhi 14 Approved No.:6/5/82-
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Status: Approved
4.7 of HBP vl as per details given below or as applied by the firm, whichever is less:
Item of Export
Qty
SI No
Item of lmport
Quantity allowed
kg/kg
4-(2,2‐
Epoxypropoxy)-9H―
carbazole
powdcr
l kg
1,3-Cyclohexanedione
1 80
2
Phenylhydrazine
Hydrochloride
256
3
Methanol
200
4
Hydrochloric acid(3 5%)
Not an importable
item
Ｅ
Ｊ
Raney Nickel
0100
6
Potassium Hydroxide
0591
7
Toluene
0355
8
Epichlorohydrin
0915
9
Dimethyl Sulfoxide
Not shown in process
10
Sodium Hydroxide
025
「
IDecision:Itwasdecidedt3deferthecasefor12062015for‐
“
mment:51Dcpanmttt Ofc&Pc
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鯰 I PVTLTD 29 04 2015 1 1器脇 50Ю03譴ハⅢダ [聡輛膏麗Ю 7795“ B施12Ю62m5 :01/82/050/00955/AM15/ Date:12062015 ハ No/Datc:2/82- VAN TORIES ATE LTD, : ln the light of written comments received from Department of Pharmaceuticals vide No/Date:2/82-
Case No.:53/10/82‐
ALC4/2014 No.:41/10/82- Namc:VIVIMED
: In the light of written comments received from Department of
OM No 350H/618/2014-PIぃorms)dated o5 05 2015,I was decided
PrOduCtiOn vis― a―vis actual consumption of a‖ imported inputs duly
Authorities.
casc was defercd for 12 06 2015
Pharmaceuticals vide
to call from the firm
certified by Central
―
趾
非謝rd般―ド蹴脚
鵬
3月Ю Ю
"側
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Lic No/Datc:0910059853 1Defer
25042014
Datc:12062015
: In the light of written comments received from Department of Pharmaceuticals vide
OM No. 35011/618/2014-PI(Norms) dated 05.05.2015, it was decided to call from the firm
production vis-a-vis actual consumption of all imported inputs duly certified by Central
Authorities.
cぉe、vas dcfercd for 12 06 2015
Deffered
Re-indexed
IDecisiOn:It was dccidcd to dcfcrthc casc for 12 06 2015 for comments of Departmenl of C&PC
IDecision:It was decided to deferthc case fOr 12 06 2015 for commcnts of Dcpartment of C&PC
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ALC4/2015
Deffered
Pa¨y Namc:VIVIMED
ILABS LIMITED
Status:Deffered
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澁
薦
RLA Filc
~¨
α2210014839
Date:
|:"扇扇OЮ0099/AM14/Ь 而うJЙ
062015
Meet No/Date:2/82-
File
:01/82/050/00991/AM15/
Case No.:77/10/82-
Party Name:NECTAR ALC4/2014 LIFESCIENCES 16 29042015 Re-indexed No:54/10/82-
64鵬 3月5剛"yAM夕脇誌υ 00913″蔦iF囲齋戸両面瞬1蔦蔦
Case No.:61/10/82- Par″ Namc:STERLING IMeet No/Datc:2/82-
AUXlLIARIES PVT IALC4/2015 : It was decided to defer the case for 12.06.2015 for comments of Department of C&PC. : [t was decided to remind the firm to fumish complete technical details as per Appendix and (ii) past production vis-avis actual consumption of inputs duly certified by Central Excise The case was defcrcd fbr 12 06 2015 66 器3月50Ю0320/AMlyl鷺尤男10Ю0017AMIダぼぜ盤TC0310780255 珈 :面 : It was decided to defer the case for 12.06.2015 for comments of Department ofC&PC.
Case No.:43/10/82- Party Name:SRINI Meet NolDate2182-
PHARMACEUTICALS IALC4/2015
Case No.:3/y82‐
ALC4/2014
Case No.:54/5/82-
ALC4/2014 Re-indexed 15 Party Name:INCHEM LABORATORIES PRIVATE LIMITED Re-indexed File 12062015 Name:NEW No/Datc:2/82‐ DYE‐CHEM 5 Re-indexed No.:19ノ10ノ82- Name:SRINI No/Date:2/82- Re-indexed TD、 5 File Re-indexed 15 1/AM15/ 101052014 12062015 0059967 1Defer lDate:12062015
Case No.:20/10/82-
Case No.:57/5/82‐
ALC4/2014 'Decision : It was decided to defer the case for 12.06.2015 for comments of Department ofC&PC. Party Name:NEW Meet No/Datc:2/82- Status:Deffered ALLIANCE DYE― CHEM IALC4/2015 Re-indexed PVT LTD, 29042015 70庫面〒―~~~~卜LA RL Lic No/Datc:0310780627 Ю1/82/050/00374/AM15/:03/95/040/00085/AM15/05052014 :12062015 IDecision:It was decided tO deferthe case for 12 04 2015 for comments ofDepartment ofC&PC 田所覇 ii3'AⅢy「蕩濡i蕊蕊蕊T[蕊齋菅而面万 ALC4/2014 Status: Rejected Date: :05/24/040/00020/AM15/ 109052014 : It was decided to reject the case as the firm has not fumished information despite reminders. Re-indexed LABS LIMITED ALC4/2011 29042015 Lic No/DateJ091 0060072 74 F‖ c :01/82/050/00931/AM15/ 109/24/040/00054/AM15/ 12052014 囮 凛姦dded to deferthe casc罵Fπ06 2015 forcommettξ ofbあartment of No.:y10/82- 4/2014 No/Date:2/82- νペ 19■06イムJr' :12062015 : It was decided to reject the case as the firm has not furnished information despite reminders. Status: Rejected
Case No.:19/5/82-
ALC4/2014 042015 Re-indexed No.:17/5/82- Nalne:RECKITT THCAREINDIA つ ‘ ８ つ ‘ ｅ ｍ ｍ 郷 Filc 1/82/050/00334/AM15/ :05/24/040/00053/AM15/ 109052014 No.:18/5/82- Namc:RECKITT No/Date:2/82- 15 THCARE INDIA 15 Decision : it was decided to reject the case as the firm has not furnished informarion despite repeated reminders. Namc:RECKITT No/Datc:2/82- THCARE INDIA ７ ′
Decision:ln the nght Of written comments received from Department of Pharmaceuticals their OM No 35011/637/2014-PI(Norms}dated 18 05 2015′ ■was decided to raJfy norms u para 4 7 of HBP vl as per details given below or as applied by the firm,whicheveris less: Item of Export Qty SI No Item of lmport Quantity allowed kglkg Levetiracetam l kg (S)-2-Amino Butyramide Hcl 095 2 Methylene Chloride 312 3 Caustic Potash Flakes 115 ｖ ｉ ｄ ｅ ｎ ｄ ｅ ｒ Ｓ ｕ tlr ll r t IRA may take appropriate action as per the decision of Norms Committee. 二 「1 鯰 ~財 藤 || ‐Lic No/Datc:0910060092 :O1/82/050/00917/AM15/ :09/24/040/00065/AMi5/ 13052014 :ln the light of written comments received from Department of Pharmaceuticals vide OM No.35011/653/2014-Pl(Norms) dated 20.05 2015, it was decided to ratify norms under
Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
Heparin Sodium lttCCtiOn uSP, 100001U/ml,lml Vial USP 1 No.:34/10/82- Name:DR REDDYS No/Date:2/82- TORIES 17/AM15/ 13052014 Item of Export Qty SI No Item of lmport Quantitv allowed 罫 墨 Number 茫 Heparin Sodium USP 6341m1/vial 2 Glass Vials 1 06 nos/vial 3 Rubber Stopper 1 06 nos/vial 4 Seals Plastic 1 048 nos/vial Ｅ Ｊ Sodium Chloridc BP 8.35 mg/vial 6 Benzyl Alcohol BP 001 m1/vial 7 Sodium Hydroxide USP 0 1l m1/vial 8 Hydrochloric Acid USP 0.235 m{vial 0' 19
^ 「 9 Tubing Plastic Not admissiblc 10 Filters Plastic Not admissible Anti Factor Xa Test Kits Kits Not admissible 12 Anti Factor IIa Test Kits Not admissible 13 AnalメiCal COlumns Kits Not admissible 14 AnalメiCal Guard Columns Kits Not admissible
Case No.:44/10/82-
Meet No/Date:2/82- ALC4/2014 LABORATORIES Party Name:MYLAN Mcct No7Date:2/82- LABORATORIES ALC4/2015 Re-indexed Re-indexed 12062015 隔 五」 LIMITED RLA Filc :09/24/040/00045/AM15/ 29042015 o/Datc:0910060084 13052014 :12062015 : In the light of written comments received from Department of Pharmaceuticals vide OM No. 3501l/568/2014-Pl(Norms) dated 05.05.2015, it was decided to call from the firm production vis-a-vis actual consumption of all imported inputs duly certified by Central case was deferred for 12.06.2015. Mcct No/Date:2/82- ALC4/2015 Filc :01/82/050/00488/AM15/ 「蹴賛Ъ ttyH | RLA Filc :03/95/040/00129/AM15/ 29042015 Meet No/Date:2/82- ALC4/2015 29042015 ヽf Dy. Di.€clc, fr*gt ':: .,1 Dlrecbrat€ G! n ., slFroq ft{r,lor,"n"...
Case No.:59/10/82-
ALC4/2014 Party Name:MYLAN LABORATORIES LIMITED Status:Deffered Lic No/Datc:0910060145 19052014
Case No.:86/6/82-
Status:Approved ALC4/2014 ud凛棚占どヽおbL:Ⅲ 20 052014 0310782139 Defer Date: No.:39/10/82- Re-indexed
lon:in the light of written comments received from Department of Pharmaceuticals vide
OM No 35011/507/2014‐PI(Norms)dated 07 04 2015,l was decided to rajfy norms
Para 4 7 of HBP vl as per details given below or as applied by the firm′ whicheveris less:
SI No
Item of Export
Qty
Item of lmport
Quantity
allowed kg/kg
Testosterone Enanthate
l kg
Testosterone
0720
Testosterone Decanoate
l kg
Testosterone
0652
3
Testosterone lsocaproate
l kg
Testosterone
0746
4
Testosterone Phenylpropionate
l kg
Testosterone
0685
〓
υ
Iestosterone Propionate
l kg
Testosterone
0837
No.:35/10/82-
PaゥNalnαMYLAN Me∝No/Datc2/82-
14
LABORATORIES
饉
「
しご
「
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― ― ― ― ― ― __.―
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=~IT二
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22
:01/82/050/00358/AM15/ 109/24/040/00096/AM15/
レ3 05 2014 Date:120a2015
: It was decided to defer the case for 12.06.2015 for comments of Department
Mcct No/Datc:2/82-
ALC4/2015
29042015
%1爾鳳蔦蕊π脇蔦蕊蕊π器器α酬∞ω
20
Date:
: It was decided to reject the case as the firm has not furnished information despite
reminders.
Status:Deffered
and Re-indexed
脚
87 1鷺
ら糀α
Om 5ハmダ
12062015
1
面]高he case for 12 06 2015 forcommentζ ofDepaltmcntofC&PC
―
Mcct No/Date:2/82-
ALC4/2015
29042015
Re-indexed
89
Datcl12 06 2015
Status:Deffered
and Re-indexed
Re-indexed
〒
~
Meet No/Date:2/82-
ALC4/2015
29042015
λhi
Casc No.:16/8/82-
ALC4/2014
Party Name:GLAND
Case No.:71/10/82‐
ALC4/2014 NamctSYMBIOTEC PHARMALAB LTD, ALC4/2015 29042015 Status:Deffered No.:29/10/82- 10/AM15/27052014 No/Date:2/82‐ :01/82/050/00985/AM15/ 15/ 127052014
Ｆ Ｉ Ｌ Ｆ Ｉ Ｉ Ｆ Ｉ Ｌ ｒ ｌ ｌ : lt was decided to defer the case for 12.06.201 5 for comments of Department of Decision : It was decided to defer the case for 12.06.201 5 for comments of Department of Pharmaceuticals Decision: It was decided to defer the case for 12.06.2015 for comments of Department of
Case No.:100/8/82- Par,NameIPCA IMcct No/Datc:2/82-
: lt was decided to defer the case for 12.06.201 5 for comments of Department of Status:Deffered and Re-indexed ~ド…Ⅲ pu¬ 鵬 星児50Ю∞2VAM16/彫 慌 OЮ∞8はⅢyl器 鼎 Decision : It was decided to defer the case for 12.06.2015 for comments of Department of Pharmaceuticals No.:145/6/82‐ Namc:LAKE No/Date:2/82- Re-indexed 111)I:児50/00547/AM15/ No.:34/8/82- Name:MYLAN No/Datc:2/82- Re-indexed E""iri", , It *"r d""id"d t" d"f.r the case for 12.06.2015 for comments of Department of ]Pharmaceuticals No.:38/8/82- Name:MYLAN TORIES ２ ８ ２ ¨ 師 郷 Re-indexed No.:51/8/82- Name:PVS TORIES LTD F‖ e 1/82/050/00715/AM15/ No.:37/8/82‐ Namc:MSN
PRIVATE LIMITED HQ File lnr.n rit" :01 1821050100701 I ANltsl l:091241040/001 l3lAM I s/ 町 國 戸 靡 i器:3K I ~再 需 129042015 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 3501t/641l2014-Pl(Norms) dated 18.05.2015 and in consultation with technical authority present in meeting, decided to ratiry under para 4.7 of IIBP as per details below or as applied by firm whichever is lower:- Export product Export Qty. SI No Import items Q″ a110Wed kg/kg DARUNAVIR l Kg 1 2,5-Dioxopyrrolidin- I - yl(3R,3aS,6aR)- hexahydrofuro [2,3 -b] furan- 3-yl carbonate 0787 つ ４ 4-Amino-N-((2R,3 S)-3- amino-2-hydroxy-4- phenylbutyl)-N - isobutylbenzenesulfonamide l14 : It was decided to defer the case for I 2.06.20 I 5 for comments of Department of C&PC. Item of Export Qty SI No Item of lmport Quantity allowed kglkg 4-Amino-5-Fluoro-1- (2R-Hydroxymethyl- [ 1,3]-Oxathiolane-5S- yl)-1H-pyrimidin-2- one-Emtricitabine (EMS.II) l kg 1 Glyoxylic Acid 50% 160 2 2,5 Dihydroxy l,4 Dithiane 0730 3 5-Fluoro Cytosine 1.13 4 Hexamethyl Disilazane 164 Ｃ υ Dimethyl Formamide 070 98 Lic No/Date:0910060282 29052014 11♀)3月50/00944/AM15/1説;た5::0/00097/AM 1剰T聴脇臨瓢鋼齢罵騨脚F咽 IPara 4 7 of H8P vl as per deta‖s given below orそ ov l' siFr.q iirt'ri)" I sei.r qq.t. .r Udyog Ahawan' 24 IHQ F‖ e lRLA Filc :O1/82/050/01374/Aヽ115/ :34/24/040/00037/Aヽ415/ ― ― ― ― ∃
6 Triethylamine 223 7 N-Hexane 5038 8 Methylene Chloride 11908 9 Cyclohexane 126 10 Sodium Borohvdride 046 Dipotassium Hydrogen Phosphate 190 It was decided to defer the case for 12.06.2015 for comments of Department of Thc casc was dcfcrcd for 12 06 2015 Status:Deffered and Re-indexed Ⅲ器3鷺、Ⅳ。。 719/AM百隔繭蕊 Ъ ttυ側 "晨Ⅲy問器酬∞ω 43 F鰊略[鮒鵬N〕鋼ぽ″ 1器3児5ν0070″AMly陽 が::900130/AM Ⅳ におNo/D配09100604H /110062014 : It was decided to defer the case for I 2.06.2015 for comments of Department of icals. The case was defened for 12.06.2015 No.:54/8/82- 14 : It was decided to reject the case as the firm has not fumished information despite reminders. ion : ln the light of written comments received from Department of Pharmaceuticals vide OM No. 3501.1/563/2014-Pl(Norms) dated 16.04.2015, it was decided to ratify norms Party Name:ALMELO PVT LTD
Case No.:48/8/82-
ALC4/2014 under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: No.:15/8/82- Namc:ALMELO LTD F‖ c 19/AM15/ No/Date:2/82- 5 No/Datc:2/82- 15 5 Re-indexed Rejected Namc:GLAND No/Date:2/82‐ LIMITED 5 Date: Date:
allowed kslks Darunavir l kg Chloroketone[(S)-tert-butyl 4-chloro-3-oxo- I - phenylbutan-2- ylcarbamatel (or) (3S)-3-(Tert- Butoxycarbonyl) Amino-l- Chloro-4-Phenyl-2- Butanone 159 2 p-Nitro benzene sulphnyl chloride 130 3 Isobutvlamine 206 4 Triethanolamine 00429 亡 Ｊ Activated Carbon 0100 6 4-Dimethyl aminopyridine 0024 7 Potassium carbonate 00H 8 Sodium borohvdride 100 9 N-Methy[ pynolidone Notc rcquircd in RXN 10 2,3 dihydrofuran 145 11 Triethylamine 540 12 Methanol 320 13 Isopropyl alcohol 3764 14 Hexane 037 Ｅ Ｊ ４ ■ Toluene 050 16 Methvlene chloride 14366
Case No.:106/8/82‐
ALC4/2014 Parw Name:BAYER Mcct No/Date:2/82- CROPSCIENCE ALC4/2015 LIMITED 29042015 1淵鼎α“Юラ晨萌 12062015 It was decided to defer the case for 12.06.2015 for comments of Department of C&PC. Status:Deffered No.:60/10/82‐ 4/2014 and Re-indexed 12062015 : lt was decided to defer the case for 12.06.2015 for comments of Department of 26 Name:BIO― TECH iMcctNo/Datc:2/82- PVT IALC4/2015 」 一 ¨
― No/Datc:2/82- Re-indexed 042015 :01/82/050/00741/AM15/ 12062015 [""i.il. ,l-*". d""id"d io Jeiir the case for 12.06.2015 for comments of Department of C&PC Status:Deffered Re-indexed Lic No/Datc:0910060470 17062014 :12062015 「Ю 8器 3児50ЮO"6/AMこ隔瓢蕊蔦Ⅷ鼎α "Ю““θ阿 ~ :蹴懸冊AIttF雨~ |… Re-indexed 109 : ln the light of written comments received from r OM No 35011/676/2014-PI(Norms)dated February import itcms frOm foreign supplicr and Past production inputs duly ccrtiflcd by Central Excisc Authoritics for the firm. case was dcfcrrcd for 12 06 2015 12062015 Department of Pha rmaceuticals vide 2015, It was decided to call COA of vis-a-vis Actual consumption of all the period 2013-2014 and 2014-15 No/Date:2/82- 042015 ― | 1:01/82/050/00562/AM15/ : Il was decided to reject the case as the firm has not furnished information despite reminders. ALC4/2015 29042015
Case No.:20/8/82‐
ALC4/2014 沢謎胤ツν"~認鵠器 ERO Re-indexed No.:77/8/82‐ No.:30/8/82- Name:INDIAN No/Datc:2/82- IRLA F■c AM15/: 139/AM15/117062014 No.:160ノ6/82‐
rion : In the light of written comments received from Department of Pharmaceuticals vide OM No. 3501 I /5 80/201S-PI(Norms) dated May 2015, it was decided to call from the firm following technical details: (a) COA of the Export Product of relevant batches. (b) COA from Foreign Supplier for the relevant consignment of Import Item. case is deferred for 12.06.2015 No.:83/18/82- Par,Name:INDIAN ‐ Mcct No Date:2/82- 4 IMMUNOLOGICALS ALC4/2015 Lic No/Datc:0310785856 :01/82/050/00982/AM15/1:03/95/040/00230/AM15/23062014 ¨ ¨ｉ ｎｄ ｅ ｘ ｅｄ 岨 Ｒ ｅ ｍ ｎｄ Ｓ ａ No.:111/8/82- Party Namc:THINQ PHARMA‐ CRO No/Date:2/82- 129042015 う ι C"* N.r?3/E/EL F* M""t N"/D"t"r/8} l6t"tr- ALC4?O]4 IName:METROCHEM l,etC+tZOtS ].l,pprovea lepl pvr. lro. 1ze.o4.zots HQ File lnla rite ]Li".N"tO"t".le rOOO05 15 F"f"r D"r" :Ol l82l 0501007 37 / AM | 5 t :09 t24t 040/00 I 5 I /AM I 5/ I 9.06.20 I 4 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/645/2014-PI(Norms) dated 29.04.2015 and in consultation with technical authority present in meeting, decided to ratifu norms under para 4.7 of HBP as per details below or as applied by firm whichever is Export product Export Qty. Si No Import items Qty. allowed kg^g LEVOSUしP!RIDE l Kg 1 METHYL‐ 5‐(AMNOSULFONLY)‐ 2‐ METHOXYBENZOATE 091 つ ４ (S)(‐ )‐2 AMNOETHYL‐ 1■ (ETHYLPYRROLIDNE) 052 Status:Deffered and Re-indexed 14 15 Re-indexed 15/ H3田既蕊扇蔦 iξ
"MITED 棚 児5α∞η5/AMⅣ隔 乳 υ話;」1蔦 画 O/Datc 0310785804 23062014 匿雷漱習萄 82 12062015 Re-indexed 29042015 :01/82/050/00716/AM15/ 聯た5110/00096/AM15/:lill::::5馬 雨可5155718 12062015 Re-indexed RLA Filc No/Datc:0310786143 :03/95/040/00250/AM15/ 27062014 :12062015 Parυ NamaSAWY IMeetNo/Date2/82- CARE&COSMETICS IALC4/2015 Re-indexed PVT LTD 29042015 :12062015 「M | Pary Name:HJ AROCHEM IALC42015 PVT LTD, 29042015 1幣賃茫 _2/82- Re-indexed Parw Name:FORACE Meet No/Date:2/82- POLYMERS(P)LTD ALC42015 29042015 No/Datc:0510389232 1072014 12062015 comments of Department of Re-indexed :12062015 ♭9042015 ILIMITED 29 No.:52/8/82‐ No月)ate:2/82- 5 Filc 5/.27062014 Name:PREGNA 魃
F濡而~鯰雫 : It was decided to defer the case for I 2.06.201 5 for comments of Department of Status:Deffered and Re-indexed 12062015 : It was decided to defer the case for 12.06.2015 for comments of Department ofC&PC. Mcct No/Datc:2/82- Status:Deffered No/Datc:2/82- 12062015 Re-indexed :12062015 Re-indexed 10060577 1語屁 |:脚冊 No/Datc12/82- ヽ
Case No.:64/10/82-
ALC4/2014 モ鼈 [=nt No.:83/8/82- Re-indexed 109/AM15/104072014 'aゥ NamcSATYAЛ T F絆畦 LS No/Date:2/82- 123[i,『 ]::7::;;:::iflテ[::'1;l,:;:::::,1↓i:; 10786462 Dcfcr No.:44/15/82‐ Namc:HETERO Re-indexed LIMITED
IPhannaccuicJs
: ln the light of written comments received from Department of Pharmaceuticals vide
OM No 35011/563/2014-PI(Norms)dated 16 04 2015′
t was decided to ratify norms
## Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
DARUNAVIR(DAR)
Tert-butyl(S)- 1 -[(2 S)-
oxiran-2-yll-2-
phenylethylcarbamate
(S,S)-(BOC Epoxide)
(or) (2S,3 S)- 1,2-Epoxy-3-
(Boc-amino)-4-
phenylbutane (or)(2s,3s)-
1,2-epoxy-3-
(butoxycarbonyl)amino-4-
phenyl butane or (2s,3s)-
1,2-epoxy-3-
(butoxycarbonyl) amino-
4phenyl butane (S,S)-BOC
Isobutyl amine
p-Nitro benzene sulphonyl
chloride
2,3 Dihydrofuran
N-Methyl pyrrolidone
も∫秘ぴ
つ
Ｄ
No.:21/8/82‐ IPatt Name:MYLAN IMeet No/Datc2/82-
TORIES
5
ｒ
ｉ
聟
」
♂
Ｆ
」
「
15
Toluene
050
## Case No.:50/18/82-
ALC4ノ2014
ParッNamciSRINI
PHARMACEUTICALS
LTD,
No/Date12/82-
Re-indexed
12062015
: lt was decided to defer the case for 12.06.2015 for comments of Department of
Mcct No/Datc:2/82-
ALC4/2015
29042015
鵬
3児5α∞η はMⅣI粉淵
υ剛%晨剛yl悧
辮
ЮЯ ∞ω 飽
: lt was decided to reject the case as the firm has not fumished information despite
reminders.
Meet No/Datc:2/82‐
ALC4/2015
Re-indexed
29042015
1麒
I蔦膨靡
蕊研需需肩¨
31鵬
3児5υ0098αAM Ⅳ陪翻扇品II百 1蹴12Ю6知5
12062015
: In the light of written comments received from Department of Biotechnology vide
letter No.BT/lLl05131612010 dated 15.05.02015, it was decided to request the firm to
the strength ofthe pertussis bulk in terms of OU/IU.
casc is dcfcrrcd for 12 06 2015
No/Datc:2/82-
Re-indexed
042015
: It was decided to defer the case for 12.06.2015 for comments ofDepartment of C&PC
Re-indexed
:12062015
鵬高蕊漏」隔ち漏精∽∞り
AMξぼギ鼎“
4∞“翼
5
~脚鰹滲韓
~
綸
:,
｀
マ疇 可]TI .
つ
y澤野■■ 〔
躙編どふ
Iミ11ヽぶ
e
Casc No.:36/8/82‐
ALC4/2014
Partv Name:RA CHEM
## Case No.:200/6ノ82-
ALC4/2014
Parw Name:PANACEA
BIOTEC LTD,
## Case No.:72/10/82‐
ALC4/2014
CALCIUM PRIVATE
## Case No.:70/8/82-
ALC4/2014
32
10072014
LIMITED
Party Name:IPCA
No.:103ノ8/82-
~1基
動傾偶
T2/82‐
ALC4/2014
LIMITED
1器3場5υ∞
%7ハi蔦囲蕊扁
Lic No/Datc:0310787202
220720]4
ion : ln the light of written comments received from Department of Pharmaceuticals vide
OM No. 35011/662l2014-Pl(Norms) dated 18.05.2015, it was decided to ratify norms
' Para 4.7 of HBP v1 as per details given below or as applled by the firm, whichever is less:
Item of Export
Qty
SI No
Item of lmport
Quantity
allowed kglkg
Benzyl-(2S)-2-Amino-3-[3-
Methylsulfonyl)Phenyll Propanoate
HydrochlorideI Synthon C ]
l kg
1
L-Proline
055
2
Ciric Acid
1368
3
(S)‐ N‐ Butoxycarbonyl‐ 3‐
Bromo Phcnylalaninine(or)
(S)‐ N‐30C‐ 3‐
Bromophenylalaninc
1909
4
Dimethyl Sulfoxidc
(DMSO)
８
う
ι
う
ι
5
Iso Propyl Alcohol
684
6
Methylene Chloride (or)
Dichloromethane (or)
Methylene Dichloride
1306
f
hA ,.y t.k" .pp.pr"t" *ti-n as per the decision of Norms Committee.
Re-indexed
面
3]二TItwasdecidedtodeferthecasefor12062015forconlmentsofDepartmentof
IC&PC
脚町IW万[冨
reminders.
Status:Deffered
[;「雪ヨ
ll1/3/82‐
―一一―一-2聖2里1______土_____―J
TORIES
No.:2/6/82‐
U Aulsl 122.07 .20t4
12062015
:It was decided to reJcctthC Casc as the fl■
ln has not imished infoH:lation dcsplte
Namc:ALEMBIC
鵬
星児5υ∞
"yAm」
| 1器
器
αⅢ∞
“"4躊
12Ю6矧5
rion : In the light of written comments received from Department of Pharmaceuticals vide
OM No. 3501l/41712014-PI(Norms) dated 22.01.2015, it was decided to call from the firm
of Master Batch Formula for each strengths of export product duly certified by their Quality
Incharge, showing net content of APIs and each ofthe excipients.
casc is defcrred for 12 06 2015
No/Date:2/82-
4/2015
Re-indexed
042015
RLA F‖ e
ILic No/Datc:0510390158
HΨ rne lKLA rllC L:●
lNυ′りal
:01/82/050/00730/AM15/:05/24/040/00205/AM15/106082014
12062015
: It was decided to call from the firm following information:
Copy of Drug Manufacturing License (DML) indicating approved
export products.
Pharmaceuticals specification for each ofthe export products.
Packaging /presentation of export products specirying quantity of contents of export
products in each ofthe packs
iv)
Master Batch Formula indicating quantitative requirement for each of the ingredients
duly certified by the production and qualities control in charge.
v)
Manufacturing process involved in production ofthe export products indicating the level
of wastage /recoveries ofvarious solvents / raw material during the process.
The case was deferred for 12.06.201 5
―
一
躙
1
財
Re-indexed
B8鵬
星児5υm m5AM百1 1冨
鼎
α側創
"22B諸
12Ю6狙5
Decision : it was decided to remind the firm to fumish a copy of Master Batch Formula
duly certified by Quality Control In charge.
Namc:RECKITT
THCAREINDIA
No/Date:2/82-
TD,
臨
鳳
蕊
|…
~~~
Ю7/24/040/00179/AM15/
O106502隋
lts received frOm Department of Pharmaceuticais vide
dated 13 05 2015,and in cOnsultation with technical
)revise norms under para 4 7 of HBP as per deta‖ s
eris lower:
Export product
Export
Qtv.
SI No
lmport items
Qty. allowed per
unit of export
product
KANAMYCN ACID SuLPHATE
FOR NJ BP 2CM, IN 15 ML
VIAL
Vial
1
KANAMYCIN ACID SULPHATE
2.8225gmlvial
concerned may take further necessary action as per above decision of Norms committee.
No.:17/15/82‐
Pa●y Name:SURVIVAL
14
TECHNOLOGIES
Re-indexed
PVT LTD
:12062015
Status:Deffered
Re-indexed
Partv Name:ENCUBE
ETHICALS PVT LTD
Re-indexed
HQ Fnc RLA Filc
:01/82/050/01220/AM15/103/94/040/00494/AM15/
12062015
:Dcpartmcnt of Pha‖ 1laccuticals vide their OM No 350 H/633/2014-PI(No:11lS)datCd
10.04.2015 stated that they have examined the matter and some discrepancies have been
in the quantities of various inputs applied for import and the certificate about past
of various export products and corresponding consumption of different inputs.
in view of above it was decided to seek clarification / Confirmation from the applicant
the CA certified consumption / production data enclosed with the application has correct
On receipt ofresponse from the company the matter would be processed further.
casc was dcfcrrcd for 12 06 2014
爾紆牌 1翻F
File l
## Case No.:254/13/82-
ALC4/2014
Party Name:SEQUENT
## Case No.:217/13/82‐
ALC4/2014
:01/82/050/00666/AIヽ415/
⌒
File
140
F‖e
10788314
LTD
10788513
12062015
腰F
10788620
141
Filc
43
Decisioll:ln the light of written comments received from Department of Pharmaceuticals vide
their OM No 35011/570/2014 Pl(Norms)dated 16 04 2015,and in consuLaJon wth technical
authority present in meeting, decided to revise norms under para 4 7 of HBP as per deta‖ s
given below or as applied by firm whicheverislower:‐
Export product
ExpOrt
Qty
SI No
lmport items
Qty. allowed
LEVOFLOXACIN
HEMIHYDRATE
lkg
1
LEVOFLOXACIN Q ACID
0 8571 kg/kg
RA concerned may take further necessary action as per above decision of Norms committee.
NamclCOVALENT
LABORATORIES
## Case No.:55/15/82_
ALC4/2014
И
41器
島児
5剛34νAMly
Re-indexed
Re-indexed
Date:
12062015
## Case No.:16/10/82-
Partv Name:GLAND
Mcct No/Datc12/82-
ALC4/2014
PHARMA LIMITED
ALC4/2015
No.:45/15/82-
4/2014
29042015
: It was decided to reject the case as the firm has not furnished information despite
reminders.
Name:GLAND
Mcct No/Date12/82-
LIMITED
ALC4/2015
29042015
1棚‰腑““
db“b tt mscfor 2に劉5b∞繭is OfDepament Of
No/Datc:2/82-
No.:4/8/82-
4/2014
Party Name:HONOUR
LAB LIMITED
Lic No/Date:0910060963
Re-indexed
Meet No/Date:2/82-
Datc:12062015
´
ｂ
12092014
12062015
一 |
:12062015
: In the light of written comments received from Department of Pharmaceuticals vide
OM No. 3501 I /41 7/2014-PI(Norms) dated 22.01.2015, it was decided to call fiom the firm
ofProduction and consumption certificate from the firm duly certified by Central Excise
casc is dcfcrrcd for 12 06 2015
1蹴辮似∞ω%5
Re-indexed
148
畷
149
:12062015
: It was decided to defer the case for 12.06.2015 for comments of Department ofc&pc
: ln the light of written comments received from Department of pharmaceuticals vide
oM No. 35011/580/2014-Pr(Norms) dated May 2015, and in consultation with technical
rrity present in meeting, decided to revise norms under para 4.7 of HBp as per detairs
:01/82/050/00670/Aヽ415/
rion : ln the light of written comments received from Department of pharmaceuticals vide
OM No. 35011/582/2014-Pl(Norms) dated 18.05.2015, and in consultation with technical
)rity present in meeting, decided to revise norms under para 4.7 of HBp as per details
below or as applied by firm whichever is lower:-
Export prod uct
Export
Qtv.
SI No
lmport items
Qtv.
allowed
kc/kc
(2R,5 S)-5-(4-amino-5-fl uoro-2-
oxo-2H-pyrimidin- l-yl)-
[ 1,3]oxathiolane-2-carboxylic
acid-( I R,2S,5R)-methyl ester
lkg
1
5-Fluoro Cyosine
050
Hexamethyl Disilazane
053
3
Mcthanc Sulfonic Acid
0007
RA concerned may take further necessary action as per above decision of Norms committee.
## Case No.:8/8/82-
ALC4/2014
37
bl器3児50/00673/AMlyl鷺危刷
:υ00320/AME「雨
`0た
o9Ю060967
711509.2014
隕
い・
う
‘
８
，
４
ｅ
ｈ
‐
５
Ｍ
卿
F‖e lRLA File
No/Datc:2/82-
15
15
Name:HONOUR
LIMITED
No/Date:2/82-
Re-indexed
No.:9/8/82‐
Name:HETERO
No/Datc:2/82-
LIMITED
。おο
・
below or as applied by firm whichever is lower:-
Export product
E xpo rt
Qty.
Si No
lmport items
Qty
a‖owed
kg/kg
TE■10FOVIR
DISOPROXIL
lkg
(R)-9-[2-
(phOSphonOmethoxy)prOpyl]adCninc
monohydratc
080
RA concerned may take further necessary action as per above decision of Norms committee.
ハ
## Case No.:115/18/82-
Party Name:ADCOCK
No/Datc:2/82-
ALC4/2014
INGRAM LTD,
ALC4/2015
29042015
HQ Filc
ALC4/2015
29042015
Lic No/1Datc:0910060989
17092014
to defer the case for 12.06.2015 for comments of Department of
: tt was decided to defer the case for 12.06.201 5 for comments of Department of
Mcct No/Date:2/82-
Re-indexed
Re-indexed
12062015
Re-indexed
12062015
Re-indexed
101/82/050/01299/AM15/
: lt was decided to deferthe case for 12.06.2015 for comments of Department of
Mect NcノDate:2/82-
備50/O1325/A岬| 1 艦
Mcct No/Datc:2/82-
ALC4/2015
Party Name:JNDAL
Party Name:HETERO
LABS LIMITED
:09/24/040/00324/AM15/
: It was decided
29042015
No.:12/15/82‐
LIヽ41TED
No.:38/15ノ82-
No/Datc:2/82-
lLtvlteo
「
: ln the light of written comments received from Department of Pharmaceuticals vide
OM No. 35011/644l2014-Pl(Norms) dated May 2015, and in consultation with technical
uthority present in meeting, decided to revise norms under para 4.7 of HBP as per details
below or as applied by firm whichever is lower:-
No.:125/8/82‐
Party Name:HETERO
14
DRUGS LIMITED,
Re-indexed
:09/24/040/00345/AM15/
:12062015
: It was decided to defer the case for 12-06-2015 for comments of Department of
: It was decided to send a copy of application to Department of Biotechnology. The
is deferred for 12 06 2015
Ю1/82/050/01347/AM15/:31/83/040/00136/AM15/'2092014
LたNoDatcS 110064915医肩
r
22 09 2014 nЯ te
Date:12062015
Decisio■:It was decidcd to deferthe case for 12 06 2015 for commcnts of Departmcnt Of
C&PC
Pa崚ゾName:HETERO
LABS LIMITED
Export product
ExpOrt
Qty
SI No
lmport items
Qty
a‖owed
kg/kg
Atorvastatin Calcium
(Amorphous/Form-
P/Crystall ine/lC H/Trihydrate)
lkg
1
(4R-cis)- l,l -dimethyl ethyl-
6-(2-am i no ethy l)-2,2 -
dimethyl- 1,3-dioxane-4-
acetate
078
Acetonitrile
537
3
Methanol
301
concerned may take further necessary action as per above decision of Norms committee.
ALC42015
29042015
## Case No.:60/15/82-
ALC4/2014
Meet No/Date:2/82-
ALC4/2015
No.:127/8/82-
Re-indexed
F‖ e
1/82/050/01296/AMi5/
129042015
AM15/19092014
Re-indexed
No.:9/15/82‐
ヽ
Mcct No/Date:2/82-
ALC4/2015
29042015
11006493
12062015
Re-indexed
翻鼎α酬
0061∞4B誰
12Ю6ふ:
“
3冊既蕊頭扁ξ匿翻i蕊::罵丁
HQ File
12062015
: It was decided to reject the case as the firm has not fumished information despite
reminders.
Datc:12062015
## Case No.:128/8/82-
ALC4/2014
浙
蔦
i」鵬蔦蕊蔦囲辮側∞御∞
3
Pharmaceuticals
Pary Namc:HETERO
LABS LIMITED
RLA File
:01/82/050/01348/Aヽ415
:31/83/040/00148/AM15
## Case No.:129/8/82-
ALC4/2014
Partv Name:HETERO
LABS LIMITED
## Case No.:3/13/82‐
Mcct No/Datc:2/82-
ALC4/2014
## Case No.:61/15/82-
ALC4/2014
: ln the light of earlier decision taken by NC in its 7 /82 meeting dated 11.09.2014, it
decided to ratify norms under Para 4 7 of HBP vl as per deta‖
s given below or as applied by
Par"Namc:EMCURE Mcct No/Datc:2/82- Statu絣
IPHARMACEUTICALS IALC4/2015 ‐Approved
lLTD 29 04 2015 '
/
1lf)星児
50/00791/AM15/
Name:HETERO
LIMITED
Re-indexed
No.:130/8/82‐
Re-indexed
銚∬
「
firm, whichever is less:
Item of Export
Quantity
S′ No
Item of lmport
quantity
recommended
PrOchlorperazinc
Ediッlatc lnJec■on USP
10 mg/2 ml
l kg
1
Prochlorperazine
Edisylate
16.60 mg/vial
2
V9239 FM259/O FLCO
006 Scnlm Stopper
Relevant, As per
packing policy.
（
３
13Mヽ4 Flip― Off Scal
4020 Dark Blue
Decision : It was decided to defer the case for 12.06.201 5 for comments of Department of
Pharmaceuticals.
ALC4/2014
## Case No.:29/18/82‐
Re-indexed
: It was decided to defer the case for 12.06.2015 for comments of Department of C&PC.
1 1
No.:176/13/82‐
Mcet No/Datc:2/82-
14
ALC4/2015
29042015
Decision : It was decided to defer the case for 12.06.201 5 for comments of Department of
Pharmaceuticals.
No.:37/15/82-
颯
14
: lt was decided to reject the case as the firm has not furnished information despite
reminders.
Parw Name:BDR
PHARNIACEUTICALS
NTERNATIONAL
Parw Name:GLAND
PHARMA LIヽ41TED
Par″ NamelM J
ヽ「万FC五再下高肩面憂両面丙百1~~
No.:9/2/82‐
and Re-indexed
つ
４
８
つ
４
¨
ｍ
那
Ｔ
Ｎ
Ａ
Ｌ
Ｊ
Ｕ
Ｂ
‐
」
Ｔ
Ｄ
Ｎ
ａ
ｍ
虹
LTD
Filc
179/AM15/
1/AM15/07102014
0061067 Dcfcr Datc:
Ｆ
Ｉ
Ｉ
Ｉ
:In thc light of carlier decision takcn in mceting n0 18/82 datcd 18 02 2015,it
decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as
ied by the firm, whichever is less:
may take appropriate action as per the decision of Norms committee
Namc:PORUS
TORIES PVT
，
４
８
つ
４
ｅ
ｍ
ｍ
郷
15/ 09102014
臨‖
:鳳1腑“
dd“Ю“お“
he ca“お‖
2“ 2創5缶comments of Department of
No.:49/18/82‐
Name:PRECISE
No.:42/15/82-
N"**PVSACRO lM""tNo/Drt"2/82- ;Sr"tr"D"ff"."d
つ
４
０
４
Ｄ
ａ
‐
５
Ｍ
脚
NmcPVSAGROI
畷
Ⅲe ~~~~~日面馬雁扇百万ioo61105 1Defcr ~~~
1濶
d2/82咄
¨
ｍ
Export
Qty.
SI No
Import items
Qty. allowed
Orlistat
Pcllets 50%
l kg
Orlistat
0505/kg
η瓢
]蕊扁
囮
鸞
浙
面∞a"3淋
s
1訥111:ellililldCCidedtodcferthecasefor12.06 2015 for comments ofI)cpartmcnt of
BIOPRODUCTS LTD,
IALC4/2014
1器3児50/O1300晨Mly Ъ 危刷:υ00290AMly脊
∬盤
Tα
091006HHB誰
12Ю62015
Decision : It was decided to send the copy ofapplication to Department of Biotechnology. The
case was defer for 12.06.2015.
4/2015
042015
IRLARL Lた
No/Dttα 0910061113
Re-indexed
Re-indexed
Re-indered
12062015
師戸甲蜃廠囲町
~~IMeet雨
扇面】藤
:LIFE SCIENCES
LIMITED
## Case No.:152/13/82-
IALC4/2014
1濶
納
~
## Case No.:78/10/82-
ALC4/2014
Re-indexed
浙
蔦」 B府
1別"師
: lt was decided to defer the case for I 2.06.201 5 for comments of Department of
43
No.:58/15/82-
Name:INDOCO
Re-indexed
Re-indexed
う
ん
８
つ
４
ｅ
ｍ
ｍ
郷
つ
４
８
つ
４
Ｃ
ｈ
‐
５
５Ｍ
閉
釧
No.:79/10/82-
Namc:HETERO
LIMITED
Namc:HETERO
## Case No.:80/10/82-
ALC4/2014
Party Name:HETERO
LABS LIMITED
Mect No/Datc:2/82‐
ALC4/2015
29042015
: It was decided to defer the case for 12.06.20l5 for comments of Department of
No/Datc12/82-
Re‐ indexed
: In the light of written comments received from Department of Pharmaceuticals vide
OM No. 3501 I /66412014-Pl(Norms) dated 22.01.2015, it was decided to call from the firm
of Production and consumption certificate from the firm duly certified by Central Excise
casc is dcfcrrcd for 12 06 2015
‖∬艦脚
|
No.:36/18/82‐
4ノ2014
Partv Name:APEX
Mcct No/Datc:2/82‐
PHARMA,
ALC4/2015
29042015
12062015
Mcct No/Datc:2/82-
ALC4/2015
RLA File
Lic No/Date:3110065004
Date:
:31/83/040/00151/AM15/127102014
12062015
: Itwas decided to defer the case for 12.06.2015 for comments of Department of
Meet No/Date:2/82-
ALC4/2015
29042015
岡雨ヒ
1鍬Ё
EPAK
ITECHNOLOGIES LTD
29042015
85円既
5α∞
"8ハⅢy匠翻蕊扁蔦けら鼎
C働0061ИOB施
12Ю6期「
## Case No.:81/10/82-
ALC4/2014
Status:Deffered
## Case No.:84/10/82-
ALC4/2014
Partv Name:HETERO
Status:Deffered
Pharmaceuticals.
44
1麒馬
11↓li
LIMITED
F‖ e
Name:HONOUR
Re-indexed
/94/040/00551/AM15/
No.:82/10/82‐
Re-indexed
ヽ
ぃ
一
一
一
一
一
一
一
一
一
一
一
一
・
・
一
一
一
一
一
一
一
一
一
一
一
一
一
一
一
一
一
一
一
一
Name:HETERO
No/Datc:2/82-
5
Re-indexed
LIMITED
15
1鷺就編面」
lMlξ Wttlili
Re-indexed
０
０
匠ち」務υO"05/AMy l蹴
12Ю6節T
1麗莞
「
耳而面而面蔽藤而再1蒸罵覇蔦面百肩F面扁翫:。f Deparment Of
ALC4/2014
## Case No.:276/13/82-
Pharmaceuticals.
Re-indexed
29042015
1器3児50畑403晨Mly圏蹴
00679晨Mly囲吻面繭臨
に
:i吉::n:It Was decided tO dcfcrthe casc for 12 06 2015 for commenl『。
fDepartment of ~~
|
HQ File
RLA File
Lic.No/Date:0910061 t4l Defer Date:
:01 18210501009991 AMl5l :091241040i00403/AMl 5/ 21.10.2014
Decision : ln the light of written comments received from Department of pharmaceuticals vide
their oM No. 35Oll/62912014-Pt(Norms) dated May 201.5, it was decided to ratify norms under
## Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
Item of Export
Qty
Si No
Item of lmport
Quantity
allowed kglkg
Abacavir Sulphate
l kg
1
Vincelactam
250
2
Di.tert.butyl dicarbonate
500
3
Dimethyl forrnamide
700
4
Sodium borohydride
0946
Ｅ
Ｊ
N-(2-Amino-4,6-dichloro
pyrimidin-5-yl) formamide
＾
，
４
４
０
6
Triethyl ortho formate
150
7
Tetrahydrofuran
415
|~~~IRAmaytakeappropriateactionasperthedecisionofNormsCommittee.
## Case No.:37/18/82-
ALC4/2014
CHEMICALS
PVT LTD,
Par,Name:CROWN
189
Meet No/Date:2/82-
No.:64/15782‐
No′lDate:2/82-
Name:CROWN
15/128102014
Re-indexed
詫暴誉ゞ黙i
り21瓢蕊
扁
1鷺念臆υ00557扁剛
戸
耐
F離
PHARMACHEM LTD,
t tt was d"cided to defer the case for 12.06.2015 for comments of Department of
ヘ
No.:141/13/82‐
14
No.:70/18/82-
No/Date:2/82-
Partv Name:SHIVA
No/Datc:2/82-
Re-indexed
Re-indexed
:12062015
Re-indexed
Re-indexed
14
Namc:GLENMARK
GENERICS LIMITED
LIMITED
う
^
隔
Re-indexed
ASIIASHVI
YAN PVT LTD
F‖ e
No.:6/15ノ82-
Namc:SMILAX
No/Date:2/82-
TORIES
ξ囲需爾面囲蕊
5
144/AM15/
15
No.:57/15/82-
46
Party Name:BAYER
VAPIPVT LTD
Mcct No/Datc:2/82-
ALC4/2015
Re-indexed
29042015
Decision:It、vas dccidcd to dcfcrthc case for 12 06 2015 for comments of Dcpartmcnt of
Pharmaceuticals.
貯
淵
/15/82‐
「
蹴
買
翻
乱∞
腰
謝
r":∬
鷲ぶ
留
り7開面::漁厩蕊鳳;蔦置需而91872厩蕊蔦
No.:49/15/82-
14
: lt was decided to defer the case for 12.06.201 5 for comments of Department of
Re-indexed
12062015
「
剛
200119:財
):50/01442/AM15/1甘:λ漏:,0/00734/AM15/F:il「::::5Rヌ
「Rテスヌ雨
『テF[]][:i:i「
:::i:
: It was decided to defer the case for 12.06.2015 for comments of D€partment of
Re-indexed
12062015
: It was decided to defer the case for 12.06.20l5 for comments of DepartmeDt of
No.:45/18/82‐
File
411/AM15/
AM15/61102014
12062015
Namc:EYTAN
LIMITED
Re-indexed
12062015
つ
４
８
つ
４
ｅ
ｍ
師
瑯
13/AM15/Ю 7H2014
No.:23/15/82‐
No/Date:2/82-
No.:81/18/82-
Namc:RLFNE
No/Datc:2/82-
憔繰熟担i
No.:19/15/82‐
NamclMALLADI
&
1器3児5υm30θAMIダ顆
15/11 112014
12062015
No.:20/15/82‐
NamclMALLADI
No/Datc:2/82-
&
5
File
PVT LTD
Namc:AVA
98/AM15/H H 2014
Re-indexed
12062015
Re-indexed
12062015
Re-indexed
Re-indexed
12062015
Name:TATVA
PHARMA
う
ん
８
う
４
Ｃ
ｍ
師
瑯
No.:41/18/82‐
File
No/Datc:2/82-
LTD,
15/ 12112014
PHARMACEUTICALS
LTD,
15/ 12112014
囲蕊蕊蔦
Re-indexed
^
Namc:KARNATAKA
ANTIBIOTICS&
LTD
鵬星児50/Ol“3ハMふ1粉馳OЮ
“
2ワAMI″ 雷齋
戸
而5966躊12蔦創5
No.:24/15/82-
Namc:SHIVAM
&PROTEINS
No/Date:2ノ82-
1/2015
Re-indexed
No.:46/18/82-
Namc:AVA
No/Date:2/82‐
Re-indexed
LTD,
5
F‖ e
1/82/050/01412/AN115/
15/ 13 112014
No.:65/18/82‐
Namc:DEEPAK
LIMITED
F‖ c
1/82/050/01431/Aヽ415/
99/AM15/113 112014
No.:72/18/82‐
NO.:42/18/82-
No/Date:2/82-
Re-indexcd
Re-indexed
5
13112014
ざpξ野■111
一
‐
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[liiii:::i][:i:「
[55ibta to dcferthe case for 12 06 2015 forcommcnts ofI)cpartment of
: In the light of written comments received from Department of AYUSH vide
nO T 12016/2/2015-DCC(AYUSH)dated 23 03 2015,it was decided to request
12062014
firm to provide at the earliest details ofthe herbal extracts used in formulation as required in
rs & Cosmetics Rule I 58 B for consideration of fixation of norms. The case was deferred for
No.:56/18/82-
No.:14/1y82-
Re-indexed
Namc:STERICON
PVT LTD,
つ
４
８
つ
４
０
ｍ
ｍ
郷
И囲蕊蕊雇;| 「禅器
Re-indexed
12062015
No.:65/15/82-
F‖ e
Name:ABEERS
Noノ1)atc:2/82-
Re-indexed
12062015
Re-indexed
」
Ｔ
Ｄ
一
Ｆ
ｉ
‐
ｅ
1/82/050/01352/Aヽ415/
12062015
Name:VIVIMED
: It was decided to defer the case for 12.2015 for comments of Department ofC&PC.
No/Date:2/82-
ヽ
50
HQ F‖ e
:O1/82/050/01349/Aヽ415/ :09/24/040/00438/AM15/117112014
RLA Filc
||
|
Date:12062015
Lic No/Date10910061248 1Dcfer
Status:Deffered
and Re-indexed
:12062015
: lt was decided to defer the case for 12.06.20'15 for comments of Department of
: lt was decided to defer the case for I 2.06.201 5 foi comments of Department of
|~ Case No.:41/15/82‐
ALC4/2014
緻
Re-indexed
:12062015
Re-indexed
12062015
No/Date:0910061256
|
: lt was decided to defer the case for 12.06.201 5 for comments of Department of
## Case No.:20/18/82-
ALC4/2014
Party Name:CROWN
匝正ItNo/Date:2/82-
letcqtzots
17112014
PVT.LTD..
129.04.20ts
鵬児剛創“
7Am y隔淋面蔦階∬鼎α“Ю
"2創
Party Namc:NATCO
## Case No.:39/1y82-
ALC4/2014
Partv Name:MYLAN
LABORATORIES
しIMITED
## Case No.:21/18/82‐
ALC4/2014
No.:8/15/82‐
Ｅ
υ
IMcct No/Datc:2/82-
Slatus:Deffered
No.:59/1y82‐ Par″ NamclMALLADl lMeet No/Datc:2/82-
Name:MYLAN
No/Datc:2/82-
TORIES
15/l18112014
Re-indexed
12062015
Re-indexed
12062015
15
Name:CROWN
No/Date:2/82-
ALC4/2015
29042015
”
一
ｍ
一
一
AM15/17112014
Pharmaceuticals.
## Case No.:24/18/82‐
Party Name:SUSHANT
ALC4/2014
INDUSTRIES
10791170
Ю1/82/050/01390/AM15/103/95/040/00672/AM15/118‖ 2014
12062015
: lt was decided to defer the case for 12.06.2015 for comments of Department of
No.:50/15/82‐
Patt NamcStJVEN Mcd No/D江o2/82-
Status:Deffered
14
LIFE SCIBNCES
ALC4/2015
Re-indexed
LIヽ41TED
29042015
11♀)星児
50/01337/AM15/
ALC4/2014
RLA Filc
LABORATORIES
ALC4/2015
LIMITED
29042015
Lic NolDatc:0910061263
Lic No/Date:0910061280
:09/24/040/00448/AM15/ 18112014
Lic No/Datc:0310791253
12062015
12062015
Re-indexed
Re.indexed
12062015
:01/82/050/01389/Aヽ415/ 103/95/040/00697/Aヽ414/ 20112014
## Case No.:110/18/82-
Party Name:MEDREICH
No/Date:2/82-
う
ι
つ
´
LIMITED
: tt was decided to defer the case for 12.06.201 5 for comments of Department of
Party Name:MYLAN
Meet No/Date:2/82-
RLA Filc
Aヽ115/ :09/24/040/00408/AM15/ 20112014
Mcct No/Datc:2/82-
## Case No.:23/18/82-
ALC4/2014
Mect No/Datc:2/82-
Name:LAKELAND
CHEMICALS(InlDIA)
## Case No.:52/15/82-
II[Ⅲas dccided to deferthe case for 12 06 2015 for commcnts of Dcpartmcnt of
隔:応扁剛麒蒜肩
「W両面臨蕊
Re-indexed
Status:Deffered
and Re-indexed
No.:23/13/82-
4/2014
us:DelIered
Re-indexed
Re-indexed
l M扁
臨
ぼ譜
r・W6d面“
do“缶ぬ
ette b 2“洲5b∞mmcnts ofD"artment」
iCase No.:30/18/82‐
IALC4/2014
|
Re-indexed
Lic No/Date:3410040705
:34/24/040/00218/AM15/121 112014
:12062015
| [::li::E「
「]「こ屍長
「EEE属]二『15deferthecase for 12 06 2015 forcomments ofI)epartment of
Status:Deffered
Re-indexed
12062015
## Case No.:59/18/82‐
ALC4/2014
] ~鱚
11)[〕):`0/01425/AM15/F::5漏:,0/00220/AM15/1:iil「:::ie:34100407081::112_062015
No.:yly82-
No/Datc:2/82-
TORIES LTD
Re-indexed
Name:ALKYL
No/Datc:2/82-
田所覇
=薦
肩隔面扇而薦蔦囲蕩〒面而309臓
:112Ю62∝5
CHEMICALS
15
br contments of Dcpartment of
No.:94/18/82-
Name:BEST
No/Datc:2/82-
ALUE CHEM PVT
5
lPharmaceuticals.
Ｅ
Ｉ
ヽ4cct No/Datc12/82-
ALC4/2015
29042015
Re-indexed
Re-indexed
Re-indexed
12062015
12062015
Ｆ
‐
‐
‐
２
３
８
‐
‐
‐
239
## Case No.:19/18/82‐
IALC4/2014
Party Name:NDOCO
Mcct No/Datc:2/82-
REMEDIES LIヽ41TED
ALC4/2015
MEDITEX PVT LTD 29 04 2015
29042015
No.:74/18/82- Pa中
No/Date:2/82-
4/2014
Namc:ADESHWAR
円脇蕊
i」浙
蔦肥繭而
No.:18/18/82-
4
Pa●y Namc:ANTHEA
IAROMATICS
PVT LTD,
Paty Namc:BDR
PIIARMACEUTICALS
INTERNAT10NAL
IPVT LTD
: lt was decided to defer the case for 12.06.2015 for comments of Department of
貯饗
:
IHQ File
No.:93/18/82‐
Status:Deffered
Mcct No/Datc:2/82-
Lic No/Datc:0310791380
Status:Deffered
レ・
RLA Filc
No.:16/18/82‐ Pa″
Namc:KAIRAV IMeet No/Date:2/82‐
5/ 24 112014
剛扁:1瓦jttζ l競浙品扁階吻
う
４
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Ｃ
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廓
郷
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Re-indexed
Re-indexed
画
5W∝
"8ハM百F繭両面菰蔚匠T2創4
12062015
us:lrellered
Re-indexed
:鯛脚灘き路厩璃酉万~
Decision : It was decided to defer the case for 12.06.2015 for comments ofDepartment of
Pharmaceuticals.
「 ~5:
而階淵仰791375B忠2¨ 5
12.06 2015 for comments ofDepartment of
## Case No.:15/2/82-
ALC4/2015
| ILTD 29 04.2015 1 ~
1棚児
"Ю∞
3mmσ l鵬詰∽“
3颯m夕1頭財面疏
B席1¨″∴
## Case NO.:17/18/82‐
ALC4ノ2014
Lic No/Date:03 10791453 1Defer
: 0 I /82/05 0/0 I 3 83 / AMt 5 I :03 19 4 I 040/0069 I /AM I 5/ )26. t t .20 1 4
Date:12062015
:It was decidcd tO dcfcrthe case for 12 06 2015 for commcnts of Dcparmcnt Of
に
: In th9 1ight Of earlicr dccision taken by NC in its 23/82 meeting dated
.2012, it was decided to ratify norms under para 4.7 of HBp v I as per detaiL given
/ or as applied by the firm, whichever is less:
Ｍ
叫
一
勁
Status:Deffered
Namc:DANOPHARM
CHEMICALS PRIVATE
LTD
No.:53/18/82-
TAPHARMA
PVT
File lLic No/Datc:3110065095
lglAMl5/:31/83l040l00057lAMt't25.tt.Z}t4 )Date:tZ.O6.2Ot5
^
Export product
ExP
Qtv
SLNo
lmport items
Qty a‖oWed kg′ kg
Telmisartan
l kg
2n"o16py-4-6g1fi yl$-(1 -methYl
benzimidazloe-2-yl)
benzimidazole
0 82 kg
つ
４
4-Methyl-2biphenylcarboXy‖ c
Acid Methyl Ester
0 65 kg
3
Acetone
046k
4
Ethylene Dichlonde
1
5
Methanol
04(
6
Methvlene Chlonde
296
7
Methyl lsobutyl Ketone
072
8
N-Bromo Succinimide
056
## Case No.:15/1y82-
ALC4/2014
and Re-indexed
:It was dccided to dcfcrthc casc for 12 06 2015 for commcnts ofI〕epartment of
Mcct No/Datc12/82- Status:DefFered
ALC4/2015
and Re-indexed
29042015
1
漂≧
:Itヽvas decidcd to defcrthC CasC fOr 12 06 2015 for commcnts ofDcpartmcnt of
No.:103/18/82‐
4
10040726
Status:Deffered
12062015
厩罵:蔦AMダ
50
:
:ItwasdccidcdtOdcferthecasefor12062015forcommcntsofI)cParment Of
ン 2511魃√
Party Name:ALEMBIC
PLヽRNIACEUTICALS
Status:Deffered
and R←indexed
i
「
し7… 「~~~~
匹“2m5 1
j´
Party Name:JUBILANT
Mect No/DttΣ
`j2-
Status:Deffered
H2014 1Datc:12062015
No.:43/18/82-
No.:10/2/82-
Namc:RANBAXY
TORIES LTD
Namc:YASHO
No/Datc:2/82-
15
う
４
８
う
４
Ｃ
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Ｉ
Ｉ
Ｉ
Ｉ
~1紙
1鶴、
『
Re-indexed
Re-indexed
Date:12062015
: In the light of wfitten comments received from Department of Chemicals and
cals vidc thcir U O No 14010/64/2013-Ch II dated 15 04 2015, it
、vas
to ratify norms under Para 4.7 of HBP v I as per details given below or as
by the firm, whichever is less:
1輻
DI闊
~IRLARL Lに
No/Datc2910025174扇
GENERICS LTD
四¨ 1勒師躙¨ 町
~
M扁
剛蕊∞
%0ハⅢ
yレぶ器α
"Ю"Иη
PCtrDに
Exoort Product
Qty
SI N
lmport Product
Quanity
STERO TAM 200(Tal10W Alllinc Ethoxylatc/Ta1low
Aminc 20 mole Ethoxylate)
l kg
TALLOW AMINE
0 2361 kg
2
ETHYLENE OXlDE
0 7839 kg
STEROL 161811(A)(CctOStCtt Alctlhd 14 moに
Ethoxylatc)
l kg
1
CETO STEARYL
ALCOHOL
0 3250 kg
2
ETHYLENE OXIDE
0 1807 kg
STER PEC 4∞ (PolyCthylcne Clyco1 400)
l kg
DIETHYLENE CLYCOL
0 261l kg
2
ETHYしENE OXlDE
0 7589 kg
STER PEG 4000 (Polyethylene Glycol 4000)
l kg
DIETHYLENE CLYCOL
0 0469 kg
2
ETHYLENE OXIDE
0 9731 kg
STERO DEEA‐ EX(N,N‐ DicthylcmanOlalninc)
l kg
DIETHANOL AMINE
0 6551 kg
2
ETHYLENE OXIDE
0 3949 kg
,■H20И
ALC4/2014
## Case No.:64/18/82-
12062015
Re-indexed
Partv Name:lND-SWIFT Meet No/Date:2/82-
Status:Deffered
No.:114/18/82-
4/2014
LABORATORIES LTD,
ALC4/2015
and Re-indexed
29042015
## Case No.:26/18/82‐
Partv Name:SADHANA
Mcct No/Datc:2/82-
ALC4/2014
NITRO CHEM
ALC4/2015
Re-indexed
LIMITED
29042015
No.:22/15/82-
Par″ Narne:SHASUN
Meet No/Date:2/82-
4
PHARMACEUTICALS
LIMITED
ALC4/2015
29042015
Party Name:DEEPAK
NITRITE LIMITED 鱚
Lic NoノlDate:0410159798
Ol 12 2014
: In the light of earlier decision taken by NC in its l8/82 meeting dated 18.02.2015, it
decided to ratifu norms under Para 4.7 of HBP vl as per details given below or as applied by
firm, whichever is less:
12062015
12062015
12062015
Re-indexed
12062015
430/AN115/
No.:92/18/82-
Name:TATVA
PHARMA
つ
４
８
う
´
Ｃ
ｍ
ｍ
那
PVT LTD
臨
菰肩ξ
Filc
C&PC
Filc
PAROXETINE TABLETS
20 MG
l kg
1
PAROXETrNE
HYDROCHLOR:DE
22 20 mg/20 mg
Tablet
PAROXETINE TABLETS
30 MG
l kg
1
PAROXETINE
HYDROCHLORIDE
33 30 mg/30 mg
Tablet
PAROXETINE TABLETS
40 MG
l kg
PAROXETINE
HYDROCHLORIDE
44 40 mg/40 mg
Tablet
RA COncerned may
necessary action as per above decision of Nc
:It、vas decided tO defcrthe case for 12 06 2015 for commcnts of Department of
:It was decided to deferthe case for 12 06 2015 for comments of Department of
ヽ
No.:89/18/82-
NamclBALAJI
LIMITED
鱚
| I P9 04 2015
1棚
児5υ釧65ハmy猟
監
OЮ創剣ハmy厩
蜃
110065116
12062015
No.:67/18/82-
Namc:BENZO
INDUSTRIES
ATE LIMITED,
Filc
No/Date:2/82-
5
Re-indexed
10791619
12062015
12.06.2015 for comments of Department of
F33児50/01426/AM15/
No.:15/18/82‐
Namc:CORAL
No/Datc:2/82-
5
NoノlDate:2ノ82-
Re-indexed
12062015
TORIES LTD,
15
19/AM15/
15
Re-indexed
|:::::]liO/00838/AM15/1:::|】
llP「|°
0310791657[:i:12162015
: It was dccidcざto defcr the casc for 12 06 2015 for comments of Dcpaiment of
us:lrellereo
Re-indexed
;i&* d;;id"d i;-a"r.. fi" "ur"
ro, r z.oo.zois lot
"ornrntnts
of Department of
## Case No.:87/18/82-
慧花
l鵬淵ギG鵬棚TCν"~
ALC4/2014
29042015
12062015
一
一一――一――― ~―
|。mments Of Department of
:It was decided to dcferthe case for 12 06 2015 for c
Party Name:MOREPEN
No/Datc:2/82-
Re-indexed
LABORATORIES LTD,
: It was decided to defer the case for 12 06'201 5 for comments of Department of
HQFile l
Name:ABEERS
CEUTICALS 躙II田空三
## Case No.:68/18/82-
ALC4/2014
CHEMICALS
PVT LTD,
Stalus:Deffered
60
No/Date12/82-
No.:32/15/82-
Namc:AMINES&
No/Datc:2/82-
Re-indexed
Re-indexed
12062015
: In the light of written comments received from Department of AYUSH vide
lmunicatiOn no T 12016/2つO15-DCC(AYUSH)datCd 23 03 2015,l was dccided tO rcquest
flllll tO providc at the carlicst dctails ofthe hcrbal extracts used in f0111:ulation as required in
&CosmeticsRule 158BforcOnsiderationofixationofnorms ThccascwasdcfcrcdfOr
:It、vas dccidcd tO dcferthc casc fOr 12 06 2015 for cOmments of Department of
Case No,:57l18/82- Party Name:PAYAL Meet No/Dare:2/g2-
ALC4I}OI4
PETROCHEM ALC4/20I5
PRIVATELIMITED 29.04.20l|5
448/AM15/
10122014
12062015
Re-indexed
12062015
Re-indexed
12062015
No.:120/18/82‐
File
1/82/050/01486/AM15/
1/82/050/01423/AM15/
No7Date:2/82-
Щ
一
乱
AM15/‐ 10122014
5/ 10122014
1/AM15/H122014
and Re-indexed
12062015
Re-indexed
No.:97ノ18/82-
NainnclDYNAMIC
つ
４
８
つ
４
ｅ
Ｄ
ａ
‐
５
５
Ｍ
脚
洲
No.:119/18/82‐
Name:V.D.H.
No/Datc:2/82-
PVT LTD
:It was decided tO deferthe casc fOr 12 06 2015 for commcnts of Depa■mcnt of
19/AM15/15122014
12062015
No.:118/18/82-
Pa■y
Mcct No/Datc:2/82-
14
Name:HJ AROCHEM
ALC4/2015
Re-indexed
PVT LTD,
29042015
Lic No/Datc:0810134067
16122014
12062015
: lt was decided to defer the case for 12.06.2015 for cosmments of Department
Party Name:INDO
Mcct No/Datc:2/82-
PHYTO CHEMICALS ,ALC4/2015
Re-indexed
29042015
鷺角刷
:υ00337AMly「遡尉α
0810134056
PVT LTD
Mcet No/Datc12/82-
ALC4/2015
29042015
Re-indexed
12062015
:12062015
Ｆ
Ｉ
Ｉ
Ｉ
Ｉ
』
Ｆ
Ｉ
Ｉ
Ｉ
Ｉ
Ｉ
■ |
HQ File
:01/82/050/01472/AM15/ :05/24/040/00424/AM15/ 16122014
Biotechnology.
No.:104/18/82-
PartyName:SHREE MeetNo/Dateizl&2'
14
GANESH REMEDIES 'ALC4/2015
PVT LTD
29042015
浙」薦翻淋扁
Lic No/Datc:3410040803
:34/24/040/00245/Aヽ415/l17122014
RLA File
Lic No/Datc:0510392439 Dcfcr
:05/23/040/00417/AM15/16122014
Date:12062015
## Case No.:106/18/82-
Party Name:PANACEA
Meet No/Datc:2/82-
ALC4/2014
BIOTEC LTD,
ALC4/2015
Re indexed
29042015
IRLA F‖ c Lic No/Date:0510392443
Mlヽ7 0ヽ/24/040/00424/AM15/ 16122014
1吻
: lt was decided to defer the case for 12.06.201 5 for comments of Department of
Party Name:CADILA
HEAI´ THCARE LTD、
## Case No.:100/18/82-
ALC4/2014
Status:Deffered
Lic No/Date:2910025185
us:lrellereo
Re-indexed
1臨
No.:116/18/82-
Filc
Re-indexed
ヽ
中
゛
卍
No.:2/18/82-
Ｆ
Ｉ
: lt was decided to defer the case for 12.06.2015 for comments of Department of
う
ι
284
1型=甲
FI穆死
1璃蕊蕊淵濡蕊蔦階悩辮似∞°43臨
:It was dccided to deferthe case for 12 06 2015 for commcnts of Departrncnt of
ｄ
ｄ
．
伽
ｄ
ｅ
ｘ
ｅ
ｅ
ｎ
一
ｕ
ｓ
‥Ｄ
Ｒ
ｅ
¨ｉ
・
饉
ｎ
ｄ
Ｓ
ａ
No.:1/15/82-
Name:AUCTUS
No/Datc:2/82‐
Re-indexed
LIMITED
No/Date12/82-
454/AN115/
15/18122014
Re-indexed
12062015
No.:69/18/82‐
Name:NEW
DYE―
PVT LTD,
No/Date12/82-
Re-indexed
5/ 19122014
:It was decidcd to defcrthe case for 12 06 2015 for comments of Department of
ILIFE SCIENCES
LIMITED
Filc
ALC4/2015
29042015
and Re-indexed
12062015
Re-indexed
Decislo■:It was decided tO defcrthc case for 12 06 2015 for comments ofI)cpartmcnt of
C&PC
Ｆ
Ｌ
Ｆ
‐
２
И
Ｎ
ｏ
・
‥
２
６
帥
1躙縣器Ю
隔臨
:扁1 石P面扇
:
Mcct No/Date:2/82-
ALC4/2015
29042015
1瓢罵f百五蔦
i」
ｖｉ
ｄ
ｅ
ｎ
ｄ
ｅ
ｒ
‐
ｓ
ｕ
Decision:in the light Of writt
the計OM No 35011/628/2014
Para 4 7 of HBP vl as perdetal
en comments received from Department of pharmaceuticals
f-Pl(Norms) dated May 2015, it was decided to ratiry norms u
ils given below or as applied by the firm, whichever is less:
Item of Export
Qty
SI No
Item of lmport
ｄ
ｅ
Ｗ
Ｏ
ｙ
ｎ
ｇ
Ｑ
ｕ
ａ
嗽
t enotovrr Disoproxil
Fumarate
l kg
Adenine
0914
2
R-Propylene Carbonate
07938
3
Methanol
295
4
Diethyl-
Tosyloxymethyl
Phosphonate
2025
5
Tetrahydrofuran
428
6
Lithiuln tert Butoxide~
0536
7
Methylcne Dich10Hd3
784
8
Acetonitrile
294
9
Chloromethyl
13527
File
1/82/050/01471/AM15/
Status:I)effered
and Re-indexed
12062015
Lc No/Datc:0510392604"etr Datc
1鵠柵:器
LAN下
1棚児
"畑悦
7ハⅢσ厩脇蕊蔦階だ器がЮ〕
and
para
Par,Name:GLOBAL tt15」[R。/Datcl'/8が
CALCIUM PRIVATE .ALC4/2015
:O1/82/050/O1465/AM15/:07/24/040/00302/AM15/30122014
Re-indexed
:12062015
293 1HQ File ¨
Lic No/Date:0710107307
|
ferthe case for 12 06 2015 for commcnts ofDepartment of
霜癬謳
ILIMITED,
鯉静
IRA may take appropriate action as per the decision of Norms Committee.
## Case No.:27/15/82-
ALC4/2014
Partv Name:HETERO
LABS LIヽ41TED
Meet No/Date:2/82-
## Case No.:12/2/82‐
ALC4/2015
Decision : In the light of earlier decision taken by NC in its I 8/82 meeting dated 18.02.2015
in consultation with technical authority present in meeting, decided to ratif, norms under
4.7 of HBP as per details given below or as applied by firm whichever is lower:-
Export product
Exp
Qty
SI No
Import items
Qty in mg for export of
I Pantoprazole tablet
20 mg Tabs
40 mg tabs
Pantoprazole
Tablet
l kg
l
Pantoprazole
Sodium
21571
43 143
2
Mannitol USP
(PCarl■0125C)
4244
8488
3
Sucrose USNF
800
1600
4
Hypromcl10sc
(PharmacOat 603
3cps)USP
1 86
372
concerned may take further necessary action as per above decision of NC.
## Case No.:99/18/82‐
ALC4/2014
## Case No.:111/18/82‐
ALC4/2014
Iospropyl Carbonate
10
N-Methyl-2-
Pyrrolidone
14878
No Datc:2/82-
鵬3児wm“α
AⅢ y膨粘υ∞
%2晨Ⅵy囲鼎硼O1341η 開面扁
ecision : It was decided to defer the case for 12.06.2015 for comments of Department of
iotechnolory
IM膠
諸だ鼎α田
"斃御9淋
l丁
棚
肥ell腑“
d“dt° defe"詭螂eお‖ 2“ 2釧5お
“
ommmsJD"altmm J
隔蕊薦薫温面扇蕊瓦肩 B憩2Ю6矧5
:It、vas dccided tO dcFcrthe case fOr 12 06 2015 for commcnts of Deparrnent Of
130弔画面而
「
~価輌扁DIVIS~亜壼亜亜亘三
…
No.:84/18/82-
Namc:HESTER
No/Datc12/82-
No/Date:2/82-
5
Re-indexed
Re-indexed
12062015
鱚
躙
磁
,
decided to defer the case for 12.06.2015 for comments of Department of
Name:MOREPEN
TORIES LTD,
つ
‘
０
０
●
４
ｅ
ｍ
師
郷
No.:28/1y82-
Pary Name:DR
REDDYS
ILABORATORIES
‐LIMITED
No/Datc:2/82-
Re-indexed
Re-indexed
5
15
452/AM15/
66
IALC4/2014
HQ Filc
:01/82/050/01414/AM15/
Decision : In the light of earlier decision taken by NC in its 22/82 meeting dated
18.10.2012, it was decided to ratiff norms under Para 4.7 of HBP vl as per details given
below or as applied by the firm, whichever is less:
ExDort Product
Export Qty.
SLNo
lmport items
Qty a‖owed
Dimethyl
Acetylenedicarboxylate
Crude
l kg
1
Hydrobromic Acid
1 59 kg
2
Fumaric Acid
1 44 kq
3
Caustic Potash Flakes
3 95 kq
4
Methanol
3 00 kq
: lt was decided to defer the case for 12.06.2015 for comments ofDepartment of
decided to defer the case for 12.06.2015 for comments of Department of
「
「爾
評
面
~
囲
孵
翫
戸
F蘊
評
期
鵬
島児5υm引6/AMⅣ膨
臆
υ∞И3ハⅢダ翻
鼎
°
"Ю
的期
B諸12Ю6知5
Ｆ
Ｌ
ド
ー
洲
IALl■開PV■
1獅
盤F
[寧酬雨~翻F/82~幽
Ｆ
Ｌ
ド
ー
一
‐
３
０
４
‐
囃麒需if
15
5
File
1/82/050/01462/AM15/
No.:2/2/82-
## Case No.:3/2/82-
ALC4/2015
: lt was decided to defer the case for 12.06.2015 for comments ofDepartment of
Meet No/Date:2/82-
ALC4/2015
29042015
Meet No/Date2/82‐
Status:Deffered
Re-indexed
12062015
12062015
Re-indexed
10159999
12062015
12062015
ヽ4cct No/Datc:2/82-
ALC4/2015
Re-indexed
29042015
10134344
19012015
12062015
Ｆ
Ｌ
ド
ー
ALC4/2014
Pharmaceuticals.
Mcct No/Datc:2/82-
ALC4/2015
29042015
HQF‖ e lRLA F‖ e Lic No/Date:0910061522
101/82/050/01321/AM15/:09/24/040/00528/AM15/09012015
: [t was decided to defer the case for 12.06.201 5 for comments of Department of
1器∬
ACTANTS e)
309日間|兆、
PC
「霊胤r般‐~~
ParけNamctSHREE
BANKEY BEHARILAL
BOARD MILLS
Mcct No/Datc12/82‐
ALC4/2015
Re-indexed
ｋ
１
１
１
＝
“
―
―
29042015
## Case No.:33/15/82-
ALC4/2014
Party Name:HETERO
## Case No.:34/15/82-
Partv Name:JODAS
ALC4/2014
EXPOIM PVT LTD.
## Case No.:9/18/82-
ALC4/2014
引01
LIヽ41TED
嗣
ダ
|
Re-indexed
No.:78/18/82-
Namc:SAIBABA
赫
一
Ⅳ
Ｆ
‐
‐
‐
‐
３
‐
２
‐
‐
‐
‐
‐
:It was dccided to dcfcrthe case for 12 06 2015 for cOmments of Dcpaltment of
貯淵Д路21甲認雨可謝ド
器か
「出繭
圃
50Ю И13/AM15/1監ち漏雷υ00268ハhi百
鵬l12062015
踊
鵬
3月50畑
"8晨
m夕| 1悧
鼎
α醐
∞aω 2躊
12Ю6矧
5
No.:1/18/82-
F‖ e
Name■ODAS
PVT LTD,
No/Datc:2/82-
F‖ c
0061562
Re-indexed
12062015
15/
1/AM15/27012015
'Decision : It was decided to defer the case for I 2.06.201 5 for comments of Departmenr of
Pharmaceuticals.
No:11/18/82-
Name:ARENE
SCIENCES
No/Datc:2/82-
Lic No/Date:0910061577
13022015
No/Datc:2/82-
15
5
15/110022015
Name:HONOUR
LIMITED
No/Datc:2/82-
Re-indexed
Re-indexed
12062015
Re-indexed
File
AM15/
:It、vas dccidcd tO dcfcrthe casc for 12 06 2015 for conlmcnts of Dcpartmcnt of
No.:10/18/82-
5
5
5/
: lt was decided to defer the case for 12.06.2015 for comments of Department of
No.:12/18/82-
Namc:JODAS
No/Datc:2/82-
PVT LTD,
Re-indexed
Party Name:JODAS
EXPOIM PVT LTD,一
Status:Deffered
and Re-indexed
12062015
12062015
Mcct No/Datc:2/82-
ALC4/2015
29042015
ALC4/2015
Mcct No/Datc:2/82-
ヽ
,1 1 ,
録
1鳳、ふド
## Case No.:14/18/82-
Status:Deffered
ALC4/2014
## Case No.:121/18/82-
ALC4/2014
Status:Deffered
Lic No/Datc:0910061606
12022015
り四島児
5αmi話肩開刷
10Ю0645ハⅢ
y
## Case No.:4/2/82-
ALC4/2015
r It was decided to defer the case for 12.06.2015 for comments of Department of
No.:14/2/82‐
Name:JUBILANT
SCIENCES
Meet No/Date:2/82-
29042015
:It was dccided to deferthe case for 12 06 2015 for comments of Departmcnt of
Namc:VIRUPAKSHA IALC4/2015
Re‐ indexed
ORGANICS LIMITED 29 04 2015
12062015
Party Name:ARENE
Mcct No/Datc:2/82-
LIFE SCIENCES
ALC4/2015
LIMITED
29042015
Status:Deffered
## Case No.:5/2ノ82-
ALC4/2015
HQ Filc RLA File
Lic No/Date:0910061894
Re-indexed
Pharmaceuticals.
No.:13/18/82‐
「
1
冊
Name:HEMMO
No/Date:2/82-
ATE LIヽイITED
Re-indexed
Re‐ indexed
F‖ c
1/82/050/00029/AM16/
「
¨
50/0002はⅢθ
…
|
IDecision:It was decidcd to def
IPhal‖ :aceuticals
Status:Deffered
and Re-indexed
loll:in the light of written comments received from Department of Pharmaceuticals vide
OM No 35011/414/2014‐ PI(Norms)dated 21 01 2015,It was dccidcd to cali frOm thc flrm
production vis-a-vis Actual consumption of all the inputs duly certified by Central Excise
for the period 2013-2014 and 2014-l 5.
case was defcrcd for 12 06 2015
う
４
~臨
潔7~~~鰤
雨
ｖ
ｉ
ｄ
ｅ
ｎ
ｄ
ｅ
ｒ
Ｓ
ｕ
４
つ
乙
つ
Ｄ
Decisloll:!n the light of written comments received from Department of Pharmaceuticals
their OM No 35011/629/2014-PI(Norms)dated MaY 2015′
t was decided to ratify norms u
Para 4 7 of HBP vl as perdeta‖
s given below or as applied by the firm,whicheveris less:
Item of Export
Qty
SI No
Item of lmport
Quanuty allowed
kg/kg
Abacavir Sulphate
l kg
Vincelactam
250
Di Tcrt Butyl
Dicarbonatc
500
3
Dimethyl Formamide
700
4
Sodium Borohvdride
0946
Ｅ
Ｊ
N‐ (2‐ Amino-4,6-
DichioЮ Pyridine-5-Yl)
FoHnamlde
1042
6
Triethyl Ortho Formate
150
7
Tetrahydrofuran
415
ロギ鼎α
"Ю田"4P
No.:6/2/82-
Namc:ALMELO
LTD
12062015
3251ALC4/2015
|ヽ
F01ノ82/050/00023/AM16/:09/24/040/00043/AM16/p1042015
Date:12062015
of Department of
Out Side agenda Part B‐ ‖
Pharmaceutica:s cases
## Case No. B- L
M/s. Pharmazel (India) Prt Ltd
Meeting No 2/AM16 dated-29 04 2015 but
actua‖y held on 21 05 2015
F No01/82/162/00138/AM15/DES―
III
Decision: lt was decide to defer the case for next NC meeting for comments of Department of
Pharmaceuticals.
## Case No. B- 2
M/s. Saurav Chemicals Ltd
Mee■ng No 2/AM16 dated-29 04 2015 but
actua‖y heid on 21 05 2015
F No01/82/050/00865/Aヽ4]2/DES― IH
F No01/82/050/01382/AMi3/DES― IH
RAF No 22/24/040/00039/AM
RAF No 22/241040/00074/AM
つ
４
う
，
Adv Lic No 2210011843 dated 01 09 2011
Adv Lic No 2210013689 datcd 05 03 2013
Oecision: lt was decide to send a copy of representation of the firm to Department of
Pharmaceuticals for their comments. The case is deferred for next NC meeting.
M/s SATYA DEEPTHA PHARMACEUTiCALS LTD
F No 01/82/50/00789/AM10/DES― IH
RAF No 09/24/040/00352/AM10
Adv Lic No 0910040145 dated 03 12 2009
Decision:in the light of written comments recelved from Department of Pharmaceuticals vide
their OM No 35011ノ793/2014‐ PI(Norms)dated 18 05 2015,l was decided to ratify norms under
para 4 7 of HBP vl as per deta‖ s given below or as applied by the firm′
whichever:s less:
Item of lmport
2,5 Dialnino 4,6 Dihydroxy
Py五midine Hcl
ひ
螺
器
UdV。9。
72
Formamido-4-
Pyrimidinyl)Aminol-
2-Cyclo Pentene- 1-
Methanol
2.
(+)-2-Azabicyclo [2.2. l] Hept-5-
Ene-3-One (Vince Lactam)1 00%
1832
3
Propionic Acid
1.35
4
D(-)Tartaric Acid
1.06
5.
Dimethyl Formamide
t.t2
6
Sodium Borohydride
0226
7
Pyridine
1.00
8
Iso PropyI Alcohol
2.96
9
Methanol
5.09
10
Dichloro Methane
2.37
Toluene
r.00
## Case No. B- 4
M/s. Alchymars ICM SM Pv1. Ltd
Meeting No.2/AM16 dated - 29.04.2015 but
actually held on 21.05.2015
F No01/82/050/00H1/AM14/DES― IH
RAF.No. 04 I 24 I 04O I 0027 9 I AM 73
Adv Lic No 0410144366 dated 25 03 2013
Decision: ln the light of written comments received from Department of Pharmaceuticals vide their
OM No. 35011/549/2014-Pl(Norms) dated 18.05. 2015, and in consultation with technical
authority present in meeting, decided to revise norms under para 4.7 of HBP as per details given
below or as applied by firm whichever is lower:-
RA concerned may take further necessary action as per above decision of Norms committee.
Export product
Export
Qtv.
SI No
lm port items
Qty. allowed per
unit of export
product
Clindamycin Hydrochloride
Active
Pharmaceutical
Ingedient
1kg.
L,
Lincomycin Hydrochloride
1.222BOUtkg
## Case No B‐5
ヽ4/s RA Chcm Pharnla Ltd
F NoO1/82/050/00219/AM12/DES‐ lH
RAF No 09/24/040/00071/AM 12
Adv Lic No 0910046667 datcd 06 05 2011
73
n oi COmmei
Decision: lt was decide to send a copy of representation of the firm to Department of
Pharmaceuticals for their comments. The case is deferred for next NC meeting.
## Case No 3-6
M/s Piralllal Hcalthcare Ltd(Follllely Nicholas
Piratnal)
F No01/82/050/00557/AM13/DES-111
RAF No 03/95/040/00227/AM 13
Adv Lic No 0310701405 datcd 10 07 2012
Decision: lt was decide to defer the case for next NC meeting for comments of Department of
Pharmaceuticals.
## Case No B-7
M/s. Piramal Healthcare Ltd (Formely Nicholas
Piramal)
Mee■ng No 2/AM16 dated-29 04 2015 but
actua‖y held on 21.05.2015
No 01/82/050/00556/AM13/DES― IH
N001/82/050/00001/AM13/DES IH
No 01/82/050/01173/AM13/DES-lH
Ｆ
Ｆ
Ｆ
RAF No 03/95/040/00226/AM 13
RAF No 03/95/040/00970/Aヽ412
RAF No 03/95/040/00374/AM 13
Lic No 0310701402 dated 10 07 2012
Lic No 0310688849 datcd 30 03 2012
Lic No 0310721416 datcd 18 01 2013
Ｖ
Ｖ
Ｖ
ｄ
ｄ
ｄ
Ａ
Ａ
Ａ
Decision: lt was decide to defer the case for next NC meeting for comments of Department of
Pharmaceuticals.
## Case No 8‐8
lWs. Piramal Healthcare Ltd (Formely Nicholas
Piramal)
actua‖ y held on 21 05 2015
No 01/82/050/00256/AM13/DES―
III
No 01/82/050/00261/AM13/DES― II
No 01/82/050/00260/AM13/DES―
III
No 01/82/050/00255/AM13/DES-1‖
No 01/82/050/00928/AM12/DES―
III
Ｆ
Ｆ
Ｆ
Ｆ
Ｆ
Lic No 0310694731 dated 15 05 2012
Lic No 0310694936 datcd 16 05 2012
Lic No 0310694925 dated 16 05 2012
Lic No 0310694706 datcd 15 05 2012
Lic No 0310642739 datcd 18 07 2011
Ｖ
Ｖ
Ｖ
Ｖ
Ｖ
ｄ
ｄ
ｄ
ｄ
ｄ
Ａ
Ａ
Ａ
Ａ
Ａ
Decision: lt was decide to defer the case for next NC meeting for comments of Department of
Pharmaceuticals
## Case No. B-9
M/s. Emcure Pharmaceuticals Ltd
Mee■ng No 2/AMl`dated_29 04 2015 but
Fl●
F No01/82/050/00297/AM15/DES‐ lH
尋纂°
74
ヽ
．
RAFNo 31/83/040/00197/AM 14
Adv Lic N0 3110062302datcd2701 2014
Decision: lt was decide to send a copy of representation of the firm to Department of
Pharmaceuticals for their comments. The case is deferred for next NC meeting.
## Case No B-10
M/s Makson lnds Pvt Ltd
F No01/82/050/00889/AM13/DES― IH
RAF No 03/95/040/00394/AM 13
Adv Lic No 0310710561 dated 26 09 2012
Decision: lt was decide to send a copy of representation of the firm to Department of
Pharmaceuticals for their comments. The case is deferred for next NC meeting.
srqr
Case No
B-11 (a)
M/s. Cipla Ltd
F No01/82/050/00226/AM15/DES-1‖
RAF No 03/94/040/00985/AM 14
Adv Lic No 0310769244 datcd 05 02 2014
Decision: Committee considered case as per representation of the firm and in consultation with the
technical authority present in the meeting and observed that there is typographical error in the
recording of description of import / export item. lt was decided to correct the description of import /
export it€m in the minutes of the NC meeting no. I I /82 dated 26. I I .2014 as details given below :
From
To
ENTECAVR MONOHYDRATE
ENTECAVIR MONOHYDRATE
The rest of the minutes would remain same.
RA may take appropriate action as per the decision ofNorms Commiftee.
鴨
Ｅ
，７
′
## Case No B-11(b)
M/s. Cipla Ltd
Meeting No 2/AM16 dated-29 04 201S but
F No01/82/050/00225/AM15/DES―
III
RAF No 03/94/040/00995/AM 14
Adv Lic No 0310769240 datcd 05 02 2014
Decision: Committee considered case as per representation of the firm and in consultation with the
technical authority present in the meeting and observed that there is typographical error in the
recording of description of import / export item. lt was decided to correct the description of import /
export item in the minutes ofthe NC meeting no. lll82 dated26.11.2014 as details given below :.
From
To
Amoxicillin and Clavunlanate Potassium
for Oral Suspension
Amoxicillin and Clavulanate Potassium for Oral
Suspension USP 600m9 / 42.90m9
The rest of the minutes would remain same.
M/s. Cipla Ltd
## Case No B-11(c)
F No01/82/050/00229/AM15/DES― IH
F No01/82/050/00172/AM15/DES―
I‖
Meejng No 2/AM16 dated-29 04 2015 but
RAF No 03/94/040/00991/AM 14
RAF No 03/94/040/01009/AM 14
Adv Lic No 0310769247 datcd 05 02 2014
Adv Lic No 0310769592 datcd 06 02 2014
Decision: Committee considered case as per representation of the firm and in consultation with the
technical authority present in the meeting and observed that there is typographical error in the
recording of description of import / export item. lt was decided to correct the description of import /
export item in the minutes ofthe NC meeting no. lll82 dared26.1l.20l4 as details given below :
SI
No
From
[mport Item at column 4 for export
product Tenofovir Disoproxil fumarate
(6 export items)
'l
To
Umport Item at column 4 for export product
Tenofovir Disoproxil fumarate (6 export
items) l
A
Lamuvdine
Lamivudine
Tenofovir Disoproxil Fumarate
Tenofovir Disproxil Fumrate
,dttЪ機。だ｀よOt
76
The rest of the minutes would remain same.
## Case No B‐ 12
M/s. Cipla Ltd
F No01/82/050/00738/Aヽ411/DES― HI
RAF No 03/94/040/00350/AM ll
Adv Lic No 0310584093 dated 19 07 2010
Decision: lt was decide to send
Pharmaceuticals for their comments.
a copy of representation of the firm to Department
The case is deferred for next NC meeting.
Of
## Case No B-13
M/s. Cipla Ltd
F No01/82/050/00228/AIヽ415/DES― ‖I
RAF No 03/94/040/00979/AN4 14
Adv Lic No 0310769253 datcd 05 02 2014
Decision: lt was decide to send a copy of representation of the firm to Department of
Pharmaceuticals for their comments. The case is deferred for next NC meeting.
## Case No B-14
lWs. Perfect Biotech
MeetinB No.2/AM15 dated - 29.M.2015 but
F NoO1/82/050/00172/AM10/DES-lⅡ
RAF No 03/95/040/00026/AM 10
Adv Lic No 0310517481 datcd 27 04 2009
Decision: committee considered case as per agenda and in light of decision Gken in ,eeirg
no.42/82 dated 12.01.10 as modified in meetinB no. 53/82 dated 30.03.10, decided to ratifi/ norms
under para 4.7 of HBP as per details below or as applied by firm whichever is lower:_
77
\/[
RA concerned may take further necessary action as per above decision of NC.
Soya Lecithin
Granules
## Case No B-15
M/s lndo Phyto Chcmicals Pvt Ltd
F No01/84/050/00318/AM13/DES‐ IH
RAF No 05/23/040/00252/AM 13
Adv Lic No 0510336430 datcd 04 10 2012
Oecision: tt was decide to send a copy of representation of the firm to Department of
Pharmaceuticals for their comments. The case is deferred for next NC meeting.
Out Side agenda Part B-ll
Chemicals & Petrochemicals cases
Ⅷ
## case No B-1
M/s Shiva Pha....achem Ltd
F NoO1/82/162/00016/AM13/DES-1‖
RAF No 34/24/040/00117/AM 10
RAF No 34/24/040/00136/AM 10
RAF No 34/24/040/00206/AM!0
RAF No34/24/040/00086/AM ll
Adv Lic No 3410025487 datcd 30 10 2009
3410025693 dated 25 11 2009
3410026511 dated 03 03 2010
3410027522 dated 16 07 2010
Dec'"',o":|t *as detide to send a copy of representation of the firm to Department of C&PC for
their comments. The case is deferred for next NC meeting.
## Case No. B-2
M/s. Survival TechnologY Pv1. Ltd
Meeung No 2/AM16 dated-29 04 2015 but
F No01/82/050/00133/Aヽ412/DES― IH
RAF No 03/957040/00536ノAM 14
Adv Lic No 0310678569 dated 25 01 2012
Dec"''on, lt *.r de.id" to send a copy of representation of the firm to Department of C&PC for
their comments.,The case is deferred for next NC meeting.
0｀
Ψ
78
## Case No. B-3
M/s. Deepak Nitrite Limited
actua lly held on 21.05.2015
F No01/82/050/01000/AM12/DES―
III
RAF. No. 31/83/040 /oo737 / AM 72
Adv Lic No 3110052056 dated 22 12 2011
Decision: lt was decide to send a copy of representation of the firm to Department of C&PC for
## Case No. B-4
M/s DoriKctal Chcmicals lndia Pvt Ltd
F No01/82/050/01242/AM15/DES―
IⅡ
RAF. No. 03/941040/00390/AM 15
Adv Lic No 0310787602 datcd 04 08 2014
## Case No B-5
M/s DoriKctal Chcmicals lndia P、■Ltd
Meeting No.2/AM16 dated - 29.04.20L5 but
F No01/82/050/01243/AM15/DES‐ ⅡI
RAF. No. 03/941040 / OO247/ AM 75
Adv Lic N0 0310787845 datcd 08 08 2014
## Case No B-6
M/s. Paramount Aromachem Pr.t Ltd
F No01/82/050/01246/AM13/DES‐
IⅡ
RAF. No. 0sl24l040/00381/AM 13
Adv Lic No 0510343720 datcd 18 01 2013
F
79
## Case No. B-7
M/sV市imed Labs Limited
MeetinB No.2/AM16 dated - 29.04.2015 but
F No01/82/050/00019/Aヽ415/DES-111
RAF. No. 09/241040/00598/AM 14
Adv Lic No 0910059372 datcd 21 02 2014
their comments. The case is deferred for next NC meeting..
## Case No B-8
M/s. Hindustan Polyamides & Fibres Limited
Meeting No.2/AM15 dated - 29.04.2015 but
F No01/82/050/00516/AIヽ415/DES III
RAF. No. 03/94l040/00132/AM 1s
Adv Lic No 0310783464 datcd 29 05 2014
## Case No B-9
M/s. Hindustan Polyamides & Fibres Limited
F No01/82/050/00182/AMi5/DES‐
III
RAF. No. 03/941040/0083s/AM 14
Adv Lic No 0310765125 datcd 08 01 2014
Decision: lt was decide to send a copy of representation of the firm to Oepartment of C&PC for
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0
"S'z1s
## Case No B-10
M/s. Gopinath Chem-Tech Ltd
Meeting No.2/AM15 dated - 29.04.2015 but
F No01/82/050/00104/AM14/DES―
III
Adv Lic No 0810119304 datcd 13 03 2013
,d'l'
80
Decision: lt was decide to send a copy of representation of the firm to Department of C&pC for
## Case No B‐ 11
M/s. Navin Fluorine Intemational Limited
F No01/82/050/00446/Aヽ415/DES― HI
RAF No 03/95/040/00915/AM 14
Adv Lic No 0310772674 datcd 03 03 2014
Decision: lt was decide to send a copy of representation of the firm to Department of C&pC for
## Case No B‐ 14
M/s Gopinath Chcm― Tech Ltd
科
F No01/82/050/00562/AM14/DES■
III
価棚
'議[=範喜』
## Case No B-12
M/s. Sainor Laboratories Pvt Ltd
F No01/82/050/00528/Aヽ410/DES― IH
01/82/050/00621/Aヽ410/DES IH
RAF No 09/24/040/00040/AM ll
09724/040/00040/AM ll
Adv Lic No 0910039225 datcd 01 09 2009
0910039590 datcd 14 10 2009
Decision: lt was decide to send a copy of representation of the firm to oepartn er,t or caec rol,
## Case No B-13
M/s. Sainor Laboratories Plt Ltd
MeeJng No 2/AM16 dated-29 04 2015 but
F No01/82/050/00350/AMllノlDES― III
RAF No 0924/040/00040/AM ll
Adv Lic No 0910042075 datcd 19 05 2010
Decision: lt was decide to send a copy of representation of the firm to Department of c&pc for
81
aCtua‖Y held on 21 05 2015
RAF No 08/24/040/00231/AM 14
Adv Lic No 0810124122 dated 26 08 2013
## Case No B‐ 15
lv{./s. Chirag Enterprise
Meeung No 2/AM16 dated-29 04 2015 but
F No01/82/050/00256/AMl1/DES-lⅡ
O1/82/050/01090/AMl1/DES‐ lH
RAF No 24/24/040/00009/AM ll
24/24/040/00014/AM ll
Adv Lic No 2410029974 dated 27 10 2010
2410030871 dated 27 10 2010
Decision: lt was decided to the case is deferred for next Nc meeting for comments of Department
of C&PC.
## Case No B-16
M/s AVA Chcmicals Pvt Ltd
actua‖v held on 21 05 2015
F NoO1/82/050/00793/AM14/DES―
III
RAF No 03/94/040/00485/AM 14
Adv Lic No 0310749510 datcd 13 09 2013
## Case No 3-17
ヽ4/s Bclchcm lnds lndia Pvt Ltd
F No01/82/050/00955/AM14/DES-lII
RAF No 03/94/040/00633/AM 14
Adv Lic No 0310755691 dated 28 10 2013
Oecision, lt was decide to send a copy of representation of the firm to Department of C&PC for
their comments. The'case is deferred for next NC meeting.
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82
ヽ4/s AVA Chcmicals Pvt Ltd
Meelng No 2/AM16 dated-29 04 2015 but
F No01/82/050/00864/AM13/DES―
III
RAF No 03/94/040/00448/AM 13
Adv Lic No 0310709883 dated 21 09 2012
Decision: lt was decide to send a copy of representation of the firm to Department of C&pC for
Date:2g.04.2015
Place:New Delhi
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## Case No B-18
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