DGFT Committee Minutes
Government of India Ministry of Commerce and Industry Directorate General of Foreign Trade Maulana Azad Road, New Delhi I10011 Norms Comr-nittee-III
Para 4.7 Decision
Meeting No. 07/g2ll0li of Z0l7-18 dated 22J1.2017 considered the cases/issues under Duty
Exempion Scheme (Chapter-4) of Foreign Trade Policy, 2Ol5-20 pertaining to Chemical and Allied
p.oductsfallingunderCirapt"izq and3-0,heldon 22.11.2017 underthechairmanshipof Shri J'V'
i'atil, Addl. OCff in Room No.04, Udyog Bhawan, New Delhi'
Following members were Present:-
Shri Nirmal Kumar, Dy' Director General of Foreign Trade
Shri Arun Kumar, Consultant, Department of Pharmaceuticals'
The committee went through the minutes of earrier meeting No. 06/82 dated 08.11.2017 and
approved the same.
Note:
In certain cases the decision of the Norms committee refers to ihe Recommendations/ observations /
Deficiencies received from the concerned Technical auihority in fhe same case or a dffirent case of
another firm with the same producr. ,q ,ronnri ,opy of suln document is placed at the end of the
Minutes. In some cases, the scanned "opy
upto,oari may be-unsigned' In bo1\these instances' the
scanned "rpy uptooiri is to be acceptei. ihe Commitiee does 'it opp'on' SCOMET items and all
applic ants are understood.
MEETING NUMBER :7182-ALC4I2OI7 MEETING DATE :22'II'2017
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~けγ孵~~~ 0高温T~ … IRLA Filc :04/24/040/00073/AM16/ IMeet No/Date:7/82- :ALC4/2017 122.11.2017 Status:Deferred. 1 臨 葛 「 | CaseNo.z477t4tY2- pu.ry Na..,NAiURAL ANO :M."t No/Date:7/82- ,status:Deferred. ALC4lzOl7 ESSENTIAL OILS PVT LTD ',ALC412017 i :22.11.2017 : 7 Hqrir. RLAFite - - * iL;;.N"lDil,0riolloozs l?;o... " , t:o ittztosolog485/AM I 8/ 1:07 l24l040l0or2ol A}/r|T I 112.07 .2016 ,Date:21 .r2'20r7 t | ICase ParりName:SI IMCet No/Date:7/82- IStatus:Deferred. 81No.:290/4/82-lGROUP INDIA IALC4/2017 1 1体 LC42017 1lMITED 22.H.2017_____一 ‐ 1 -一 _____爾 一 一 ― 一 一 一 μ″ ~赫
扇 赫 rred・ ― ― 一 ~~丁 IIII… … … _… … … … ‐… 一 ― 一 一 一 ― 一 ― 一 一 一 … … J IЮ 1/82/050/00485/AM13/ 1:U〃 Z4/U4U/UUl∠υ AIVll′ / 1lZ・ υ ′.´ Viυ :ν “ しV・ん′・~・´V― | ,Case No。:501/4/82- ,Party Name:ALEMBIC 'PHARMACEUTICALS LTD IRLA F‖ e l:34/24/040/00217/AM17/ Dtte:10.01.2017 1 |・:HQ File l :01/82/050/00105/AM18/ | IDecision:Deferred. iCase No.:446/4/82- lALC4/2017 Party Name:CADILA IMcet No/Date:7/82- IPHARMACEUTICALS LTD.:ALC4/2017 1 122.11.2017 :…■ Q l ′ H Ю Filc IRLA File ILic.No/Date:0810137552 1Defer 130.03.2016 IDate:27.122017 1 , tDecision :Deferred. ; | lDecision :Deferred. Mect No/Datc17/82- IALC4/2017 122.11.2017 | 19 1ンIHQ File 貯∬鼎αⅢ 0042“8B誰ち 7■2期7 |IDecision:Deferred. J 2
I ICase No.:314/4/82‐
1 :ALC4/2017
101責0+ii~~ 1 1.nl′ oぅ′Aξ ハ′An●ぅぅ′Aヽイ1 鱚 需 :~… iLIMITED, iRLA File | :07 124 I 040 I 00247 I AM|T I M赫 僣聯蕩: 1錯r盤7 肝漑鸞 b710110658 :01/82/050/00322/AMl 8/ ‐Declslon:Deferred. | IDecislon:Deferred. I : I HマrllC ・`ちち1/b10/oo397/AM17/ 107.12.2016 1Date:27.12.20171 131o1/82/050/00232/AM18/ 1:0 _ _. … ´ ● ´ ●● 1___^」^^ιL^´ ^^ハ_― △nJう+hnl li::liIII拝i:1::lililitと:i:さと |:きむ16と:il 161 1ムf。「 1鴇ati6A b:leぎ6h iムと Iさ 。
丼
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lof D/o PharmaceutiCals fOrwarded O.M.No35011/221/2016-Pl(Norms) datedl
126.09.2017′ uploaded atthe end ofthese minutes and deferred the case. |
「「 丁~~ 【
| ICase No.:199/4/82‐ IParりName:OPTIMUS
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| :
lcase No.:200/4/82-
IALC4/2017
lm漱協調II::造き淵ツα
7鯰‐
12211.2017
'status: Deferred. '
1151責011i`
IЪち刷
:υ00473/AM17
IDefer l
lDate:27.12.20171
| 101/82/050/00208/AM18/
i iDecision: Deferred.
H Q 側 一 」 File 1/82/050/00207/AM18/ IDecision:Deferred. ヽ
Case No.:163/4/82‐ ALC4/2017 Party Name:MYLAN
I ILABORATORIES LIMITED IMeet No/Datc:7/82- lStatus: :ALC4/2017 1Approved P2.11.2017 1 |∠Z・ll・ZU1/ 1 階漱f5蒟 00645丁 F語5篇 Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded O.M. No35OL1/L9612017-Pl(Norms) dated November 2OL7 , uploaded at the end ofthese minutes or as apphed by th::||:1」よ Iよ高ll「課 (=.erl
para 4.07 of HBP Vol.1. RA concerned rnay take necessary a
I ICase No.:312/4/82‐ ParサName:GLOBAL
I :ALC4/2017 1CALCIUM PRIVATE
‐ . lLIMITED,
「警訃ぼ~孵聯獅
~獅
FttlttT:
Meet No/Date:7/82‐ IStatus:Deferred.|
IALC4/2017 1 1
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| ICase No.:289/4/82-
| ‐ALC4/2017
″轟
| |:01/82/050/00297/AM18/
IDate:10.01.2018
IRLA File
ILic No/Date:0910064489 1Defer
120.12.2016
IDatc:27.12.2017 1
|
IHQ File
RLA File
17 1fl撃 9Υ
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lDecision : Deferred.
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ICase No.:230/4/82‐ ParりName:VIRCHOW
IALC4/2017 ,PETROCHEMICAL PVT
ILTD.
Mcct No/Date:7/82‐
ALC4/2017
22.11.2017
lStatus:Deferred.
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122.11.2017
10.01.2017
:Date:27.12.2017
, ,Case No;17414182-ALC4/2017 Party Name:SUVEN LIFE
Meet No/Date:7182- ,Status
l
,
SCIENCES LIMITED
"ALC4l20l7
,Approved
''
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22.11.2017
,He File
RLA File
'Lic.No/Date:0910064570 lDefer Date: :
^- :011821050/00182/AMl8/ :0912410401005391AM171 :10.01.2017
27
r rDecision : The Committee decided to ratify norms based on the recommendation of D/o,
: rpharmaceuticals forwarded O.M. No35011/1OSl2}t7-Pl(Norms) dated 23.LO.20L7,剛評諄
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| :Decision:丁he Committee dedded to ratify norms based on the recommendation of D/o
l lPharmaceuticals forwarded O.M.No35011/105/2017-PI(Norms)dated 23.10.2017′
l lup10aded at the end ofthese rninutes or as applied bythe firm whichever is less under
l ipara4.07 of HBP Vol.1. RA concerned rnay take necessary action as per decision of NC.
| ICase No.:175/4/82‐ ALC4/2017 1Party Name:SUVEN LIFE IMeet No/Date:7/82¨ iStatus:
1 1 SCIENCES LIMITED IALC4/2017 1Approved
122.11.2017 1
2g He Fite
RLA File
Lic.No/Daie:0910064571 Defer Date:
'":01-1821050/00183/AMl8/ :091241040100538/AM17/ 10.01.2017
'
'
, Decision: The Committee decided to ratify norms based on the recommendation of D/o:
, rPharmaceuticals forwarded O.M. No3501U85/2011-Pl(Norms) dated 08.t2.2OLt ,
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)Date:21 .12.2017
1241責0「iiも‐~ ‐
| |:01/82/050/00238/AM18/
iDecision: Deferred.
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1
IHQ File
l:01/82/050/00159/AM18/
Paty Name:SUVEN LIFE
SCIENCES LIMITED
: Deferred.
iCase No.:166/4/82‐
IALC4/2017
ParりName:SUVEN LIFE
ISCIENCES LIMITED
1造:』別跡
tC782-
22.11.2017
〕
mDeferr事
126 :HQ File
l:01/82/050/00174/AM18/
IRLA File
109/24/040/00527/AM17/
110.01.2017
IDefer i
:Date:27.12.2017 1
,Decision: Deferred.
| :up10aded at the end of ‐ para 4.07 of HBP Vol.1. these minutes or as app‖ ed by the firrn whichever is less underi RA concerned may take necessary action as per decision of_I9 I lRLe rite jlic.No/Date:0910064579 ':09240400}543lAM17l'.l2.Ol.2Ol7 I lnecision : Deferred. | ICase No.:311/4/82‐ 1 lALC4/2017 ,Party Name:GLOBAL ICALCIUM PRIVATE ILIMITED, ',:07 I 24 I O4O I 00332 I AM|T I tus:Deferred. 121鵠虚 15:/:::1誠↓ |:/ , tcase No.:22gl4lg2 -.,iurryNurr.,SniibVr-Ares tMeetNo/Date:7182- :status:Deferred. i ,,ALC4t20t1 ,A CHpUtCeLS PRIVATE tALC4l2Ol7 . I ' : -- - LlMlrED 'zz'tt'zotl i ' ' | --'i- .-'
| 33 Hqnit. RLA File ,Li..No/Dut":0910064580 lDefer : : I lDecision : Deferred. j ⌒ ParりName:GLAND IPHARMA LIMITED :Mcet No/Date:7/82- :ALC4/2017 :22.11.2017 iStatus:Deferred. B誰ち 7混洲71 IHQ File Paty Name:SUVEN LIFE ISCIENCES LIMITED IMcetNo/Date:7/82- lALC4/2017 b2.11.2017 iLi".No/Dat":09 1 0064575 ;Defer iStatus:Deferred. | IRLA Filc :Uソ/24/U4U/UUDDソ/AIVl1// 112.01.2017 IDate:27.12.2017 1 : : : IDecision:Deferred. 1 1ti;`不高百罰百肩 7慰う _ : :ALC4/2017 IPaty Name:AAP PHARMA ITECHNOLOGIES INDIA IPRIVATE LIMITED :Mcet No/Date:7/82‐ 1銭#獄了 lStatus:Deferred. | | ′11HQ面ざ | :01/82/050/00237/AM18/ RLA File ',:09 12410401005 I 3/AM I 7/ 需辮α酬∞“ %3B誰ち 7■2期7 ; iDecision : Deferred. | IMeet No/Dtte:7/82- :ALC4/2017 12211.2017 | | 括ざり器α 07101109648荒 :10.o・2018: rDecision: Deferred. | :case No.:160/4/82¨ :ALC4/2017 Pary NameiVIRCHOW PETROCHEMICAL PVT LTD. IMcet No/Date:7/82- :ALC4/2017 122.11.2017 ,status:Deferred. I ) I 1341責Oriiも IRLA File i:09/24/040/00542/AM17/ 身ざ %認α 0910064605B荒ち 7.1220171 :^~ICase No.:72/4/82‐ Party Name:KOPRAN IMcetNo/Date:7/82- IALC4/2017 151x■1,ダ読f IRESEARCH 'status:Deferred. 6
⌒
ILABORATORIES LTD.
teb一―
|
IRLA File
l:03/94/040/00969/AM17/
124.01.2017 1Date:27.12.2017
:器3児5υ00080AMlν
IDecision:Deferred.
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ase No.:71/4/82‐
LC4/2017
Paty Name:FERMENTA
IBIOTECH LTD
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|
109/24/040/00584/AM17/ 021
:01/821050/00194/AM I 8/
:0912410401005841AM171 02'02'2017
l
Decision : The Committee decided to ratify norms based on the recommendation of D/o
pharmaceuticals forwarded O.M. No35OItl737l2017-Pl(Norms) dated November 2Ot7 ,
lstatus:Deferred.
1 1CaseNo.:149/4/82‐
i lLC″
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1401110「ii`
1―――一―一一、T△
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RLA File
IHQ File
:01/82/050/00079/AM18/
:03/94/040/00970/AM17/
Decision : Deferred.
|」
i l:01/82/050/00157/AM18/
| IDecision:Deferred。
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uploaded at the end of these minutes or as applied by the firm I -para +,07,of HBP Vol.1. RA concerned may take necessary action whichever is less under as per decision of NC. 「F濡繭F~ 臨 [~ 鱚而~FttT 打静崩温蔦冨蔦 T一 話 I I ~~ ~~ 蒻資 =爵繭輛覇覇襄こ IttTf堅| ハ iCase No.:188/4/82¨ IALC4/2017 「祠縦Ъ ttD.嚇r盤 「 ル istatus:Deferred. I tl ;i F3101i` IRLA File i:09/24/040/00477/AM17/ ILic.No/Date:0910064627 1Defer 102.02.2017 :Date:27.12.2017 | :Decision:Deferred. Status:Deferred.| 2 8 7 e m ¨ ¨ M e A L 2 2 . Party Name:FDC LTD 2 8 4 一 N O ・ ‥ 7 3 州 一 猥 」 C 一 C A 一 ― 「 4獅Q事ゃ 44 IRLA File '03/94/040/00991/AM17/ :Lic.No/Date:0310810972 1Defer i ::01/82/050/00081/AM18/ p6.02.2017 :Date:27.12.20171 | i iDecision: Deferred. |&CHEMICALS PRIVATE :ALC4/2017 ILIMITED 145:責01iiき IRLA File :09/24/040/00569/AM17/ :Decision:Deferred.
A[:t:wr_l I lHQ ril"-- RLA Fit.
- -- lti..No/Date:091 00646st lDeio
I
I l:01/82/Os0/00198/AMl8/ l:)9/2afia)fios4zt\Mtzt iot.oz.zOn
lDate:27l2.20fi |
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III:丁~誕 全可 ::01/82/050/00067/AM18/ 1:03/94/040/00873/AM17/ iCase No。:60/4/82‐ IALC4/2017 |l HQ File~~~ |:01/82/050/00068/AM18/ Decision: Deferred. 「 ~ 『 硯鮮陽λ ttυ話 1鶴 I 'Decision: Deferred. ― l 「
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` ~| .22.11.201I ' uQ rire ir-a riie ,li..NJo"i.,oliosrl03 r Derer Daie: -^ :011821050/00055/AMl8/ :03D5rc401008661AM171 '08'02'2017 I 5i-" ,Decision i fh. Committee decided to ratify norms based on the recommendation of D/o I pharmaceuticals forwarded O.M. No35Ott/86412015-Pl(Norms) dated 10th April }OLG , lup10aded at the end of these rninutes or as apphed by the firm whichever is less underi
para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. |
「F断面蒟あ薦筋而 Party Name:OC IMeet No/Date:7/82- Status:Deferred。 | ISpFrTAIITIES pvT_LTD_ IALC4/2017 1 1 | IHQ File 卜PEChu¶ ES PVT.LTD.1抜 γ 獄 了 | | | 艶 IRLA File ‐Lic.No/Date:0310811043 1Defer Date: Pary Name:SARNA ICHEMICALS PVT LTD RLA File :52/24/040/00066/AM17/ ILic.No/Date:0310811015 108.02.2017 IStatus:Deferred.: 臨蒜五 :¬ . ICase No。:59/4/82¨ ‐ :ALC4/2017 lParw Name:CAMPHOR & IMeet No/Date7182- IJiellrEo PRODUCTS 'ittCqzOtl llrmrpo, \22.11.2017 9
―
一
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一
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― 一 | luQ pit" tnr-e r'il. 1:011821050100092/AMl8/ :031951040100884/AMl7/ ICase No.:75/4/82- IALC4/2017 IParりName:AVA iCHEMICALS PVT.LTD., | 591i01iiも ~ ‐ 101/82/050/00083/AM18/ 田hお:蕊漁1' iDecision : Deferred. 10 :08.02.2017 110.01.2018 IPaty Name:YASHO IINDUSTRIES PVT.LTD. 艦き淵να 7泌 つ2.11.2017 Status:Deferred. | 108.02.2017 IDate:10.01.2018 ILic.No/Date:03108H041 1Defer 157 iCase No.:94/4/82- :ALC4/2017 IParりName:ZYTEX IBIOTECH PVT.LTD. 2 7 ¨ ¨ ¨ M c A L 2 2 . IStatus:Deferred・ | IHQ File ,nr-A pit. ilic.No/pate:031081 1026 iDefer ,:031951040100855/AM17/ IOS.OZ.ZOtZ :Date27 '12'2017 . i't:011821050/00102/AM18/ , n..ision: Deferred. | | .Case No.:74/4/82‐ i lALC4/2017 ParりName:AVA ICHEMICALS PVT.LTD., 1造:』TTα 782‐ ,2.11.2017 :mDeferred。 | 158 1 1 | IHQ File IRLA File i:03/94/040/00999/AM17/ :Lic.No/Date:0310811094 1Defer 109.022017 :Date:10.01.2018 : Decision: Deferred. ‐ lCase No.:70/4/82- ‐ IALC4/2017 Patt Name:AMINES& IPLASTICIZERS LIMITED IMect No/Date:7/82- lALC4/2017 122.11.2017 IStatus:Deferred.: l l 60 1HO lli3 IRLA File :Lic.No/Date:03108H124 1Defer | |:01/82/050/00078/AM18/ 110.02.2017 IDatc:10.01.2018 1 li猛霊ガ∬∬“ /82‐ istatus:Deferred. 皆温1需:&詔脳PLSI鼈き淵rα 7秘
LIMITED
p2.11.2017
D 122.
も
F]尾
Lic.No/Date:0310811142
~匡面蔦
|:03/94/040/00960/AM17/ 113.02.2017
|
| ICase No.:48/4/82-
| IALC4/2017
||
f31HQ「ie
l l:01/82/050/00056/AM18/
1 :Deciζ 161 l bLfettι j:
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e end dthese mmtteloras'Pplied byth,lTttЧ:里111:Fl‖癬
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50/00188/AM18/ 1:09/24/040/00540/AM17/
1 1Decision:Deferred.
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脇:「1搬冨咽獅正
|
:ALC4/2017
Party Name:OMTECH
CHEMICAL INDUSTRIES
IMeet No/Date:7/82-
IALC4/2017
IStatus:Deferred.|
|
PVT.LTD.
IRLA File
i103/95/040/00361/AM17/
話鱚
Ю
8H21
′
|
:霰詰1:鮮捲賑LTD lx-cqnott
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IStatus:Deferred.
~画面乖
11
|
IHQ File
‐Datc:27.12.2017 .
rCase No.:58/4/82-
166:責0,iig
Icase No,:128/4/82‐
IALC4/2017
167
IHQ File
ititiヽも
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410042943 1Defer
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l up10aded atthe end Ofthese rninutes or as applied by the firm whicheveriSless under l
l ,para 4.07 of HBP VOI.1.RA concerned may take necessary aCtiOn as per decisiOn of NC.|
「
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r
1 1:01/82/050/00136/AM18/ 1 :Decision:Deferred。 画 40/00337/AM17/ 116.02.2017 |D"rj001?93 :Mcet No/Date:7/82- LABORATORIES LIMITED IALC4/2017 Status: Approved 168 1 22.11.2017 1 -――――江に.No/D嘉:0310811264~わetr Dttα :0118210501000741AM181 :03l94l040l0l036lAMl7l :16.02.2017 | Decision : The Committee decided to ratify norms based on the recommendation of D/o ,Pharmaceuticals forwarded O.M. No35011/15L12O12-Pl(Norms) dated July 2Ot2 , ruploaded at the end of these minutes or as applied by the firm whichever is less under
para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.
… … 面 | : | ,Case No.:148/4/82‐ | :ALC4/2017 ,91011`~~‐ | ::01/82/050/00156/AM18/ 1わお t蓋誌二:De籠|∴j:~ I~ 澁 鳥LttT 1需霜 轟ダ 22.11.2017 :Lic.No/Date:0910064689 1Defer 116.02.2017 11)ate:27.122017 iCase No。:33/4/82‐ ALC4/2017 ParりName:CADlLA IHEALTHCARE LTD ICase No.:50/4/82¨ IALC4/2017 1HQ File l:01/82/050/00058/AM18/ IDecision:Deferred。 :HQ File RLA File lLic.No/Date:0810139743 1Defer Date Hq nite RLA File llic.No/Date:0810139743 Defer Date: l:01/821050/0004I/AM18/ :O8l24l040l00473lAMt7l '17 .02.2017 i-
- ---' lDecision : The Committee decided to ratify norms based on the recommendation of D/o, レ o狸鰤 ?翌堕里 Pharmaceuticals forwarded O.M. No35OLtl41412016-Pl(Norms) dated November 2Ot7 , uploaded at the end of these minutes or as applied by the firm whichever is less under, 'para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. ' 1 瑶瓢蔦薦戸~目 肝而面 | 「 IMeet No/Date17/82- :ALC4/2017 122.11.2017 lStatus: lApproved | ICase No.:96ノ4/82- :卜LC″2m7 ,721責O Filざ…… ~ : |:01/82/050/00104/AM18/ IParりName:YASHO IINDUSTRIES PVT.LTD. :RLA File l:03/95/040/00907/AM17/ 獄∬器 | ~語 需齋肝而面雨294滋、 iち:L , Decision : Deferred. I ICase No.:10/4/82- 731ALC4/2017 ,Party Name:OC ISPECIALITIES PVT.LTD. I IMeetNo/Dtte:7/82- lALC4/2017 22.11.2017 'Status:Deferred. 12 :資器 eN∝66/4/"■LC42"7 1 : | IHQ Flle IRLA File lstatus:Deferred. I
HQ File 1:01/82/050/00018/AM18/ _llililill::::|:lI:::::|:::::::l::::::::::::::|::I:ll:::i::i::lilll::::::|::::|
Case No.:176 /4182-ALC4/2011 PartyName:BIOLOGICAL E
Meet No/Date:7/82- Status: ,LTD ,ALC4l20l7 iApproved r :He File n1-n iit. ,Lic.No/Date:0910064707 :01/82/050/00184/AM l8/ ,:091241040100408/AM 171 21.02.201'7 14 .'',D*.irion: The Committee decided to ratify norms based on the recommendation olDlo r tpharmaceuticals forwarded o.M. No35011/436120L5-Pl(Norms) dated oct. 2oL5 ' : uprora.d at the end of these minutes or as applied by the firm whichever is less under I ;;r. 4.O7 of HBP Vol.1. RA concerned may take necessary l:tion as per decision of NC ¨ 百一 ― :ALC4/2017 | ILABORATORIES LTD. 22.11.2017 ,71てⅢIIITTT~1鷺へ澱 , 翻評而i=囲 IDate:27.1 1 1:6)わ '350/00071/AM18/ 103/94/040/00998/AM17/ 1 ' ________… lL― ―………………………………………………――――――~― 一二 ― Decision: De ′じじユ0■υ ■■・ ν シユツニユW“ ● : Deferred. | lcase No.:64/4/82¨ 1 1▲■´ "7● n■● 師 ヽ経ILTA IALC4/2017 ilnrionaroRlEs LrD. IRLA Fne ~ [麗 '94/040/00997/AM17/ Deferred. 型 71 13 l iCaseNo。:98/4/82‐ |卜LC″2m7 iParty Name:PANACEA ierorpc Lro., IMcetNo/Date:7/82‐ 1錯γ盤了 lstatus:Deferred. I 176 iO「iit IRLA File l:05/24/040/00551/AM17/ サ i駆鸞α“Ю 4017"8荒ン 1119マ : IMもも iヽもあ農まり /恵夕 |もiitus:Deたrred.| | 1抜#鰍了
Decision: Deferred. 血 iCase No.:87/4/82‐ :ALC4/2017 801Lバき:il IHQ File 101/82/( File 01/82/050/00095/AM18/ 一 一 「 ICaseNo.:86ノ4/82‐ IALC4/2017 IPaty Name:KRISHNA IANTIOXIDANTS PVT.LTD. IMectNo/Date:7/82‐ 1什ツ賀 「 22.11.2017 Status: Deferred. 囲画面 13873驚lIII | ~ ~甲 囮 濡 酬 濡 ~胃 漏 肝 η蕊蕊蕊yW図蕊蔦戸閉需画面田0劇"B I ttcお bn:Deれ rredI~~~~~~~~― … … 一 一 一 ― 一 ― 一 一 ― ― 一 一 一 ― ― ¨ 丁 | lν じしユ。■υ ・ ■●ν じ■しニユしuo ~「 濾 雨赫 T翻 ぽ 百 ぽ わ高温 ~ ~所蒻面高]蔦3~理需獅戸TT曜蜜藁五正 ~甲辮而 「 ~~薄 夢辮 斜隧蕊i蔦y‐膨蕊薦:蕊 1耐 漏 証 一 一 一 一 一 ― 一 ― ― ― | ICase No.:182/4/82¨ ‐ IALC4/2017 1310吾ぉ 1 101/82/050/00190/AM18/ 1 1Decision:Deferred. Paty Name:GRANULES INDIA LIMITED | 51韓QΠb lRLAFne |:6):ダ650/00191/AM18/ :09/24/040/00612/AM17/ 一 2 一 慇 一 M e A L 2 2 . ハ Pa●y Namc:BAYER VAPI PVT.LTD. IMcet No/Date:7/82¨ 1銭γ盤ソ '2.02.2017 Status:Deferred. | :HQ File :RLA File i:03/94/040/01011/AM17/ lDecision: Deferred. 14
IHQ File :01/82/050/00134/AM18/ 腑 孟扁「 甲 鰐粗∬魅|:T胤縄[fTF紀酬L胤整覇認粘ⅧΨ ttr器:| .uploaded at the end of these minutes or as applied by the firm para 4.O7 of HBP Vol.1. RA concerned may take necessary action ; whichever is less underl as per decision of NC. I 1聯為 ed peferw‐ 1海置 一 一 器 茸 称 隊γ盤了 ~~睡 NqP申:¨ ,7盤鮮 :∵銹 i藻檻雲器‰薦:峰糧冨話話蔀 :諦3覇 iPharmaceuticals forwarded O.M. No35OLtlzL7/20L5-Pl(Norms) dated November 20L7 , uploaded at the end ofthese rn:nutes or as applied by the firm whichever is less underl lpara 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. | 師翻呼ぽ赫 瀞 ~1辮 需画面」圏誦蔦『 ~~StaLご漢蔽通. 「爾蕊甲藤 ~ IParりNameiOGENE SYSTEMSINDIA LTD. ´~1良 LA File 891責Ori18 ~ :01/82/050/00163/AM18/ :09/24/040/00625/AM17/ . I)eclslon:Deferred. ICast No.:76ノ4/82‐ Party Name:ATHENA DRUG IDELIVERY SOLUTIONS IPRIVATE LIMITED IRLA Fllc 103/94/040/01078/AM17/ 商品面高面藤 iStatus:Deferred. 1銭γ盤了 | [i顆赫丁B間 | IDefer lDate:27.122017 1 1ALC4/2017 1 1 PO10h僣~‐ : 101/82/050/00084/AM18/ 1 1Decision:Deferred. F ‐ ‐ 9 ‐ ICase No.:80/4/82¨ ‐ALC4/2017 .HQ File 101/82/050/00088/AM18/ ‐Declslon:Deferred。 IPaty Namc:ATHENA DRUG IDELIVERY SOLUTIONS IPRIVATE LIMITED IRLA Flle :03/94/040/01072/AM17/ jMeet No/Date:7182- \ALC412017 lzz)t.zon :Lic.No/Date:03 I 08 I I 5 I 3 01.03.201 '7 IStatus:Deferred.: | 鵬L話 121従ガ l∫″“ /82‐ : IMeetNo/Date:7/82‐ IALC4/2017 ,Status: Deferred. 15 1抜γ盤了 128.02.2017
劾I而 'お `3/Diもbjibtti i504'Defer ~ 01.03.2017 1Date:10.01.2018 P鉗りName:PARAMOUNT :AROMACHEM PVT.LTD., lRLa nte |:05/24/040/00604/AM17/ lMcet No/Date:7/82- IALC4/2017 ,2.11.2017 1面燕;扇肩面0042198 pl.03.2017 Status:Deferred. IDefer lDate:27.12.2017 ParりName:ALTA :LABORATORIES LTD. Meet No/Date:7/82- ALC4/2017 22.11.2017 囮 蕊 ;
Case No.: 171t4182-
Parry Name:AUROBINDO Meet No/Date:7182-
\ ^r r,,rnnrt
ipr+aRva LIMITED
lALC4l20l7
Ы
M「ED I銭
『獄了
Status:Deferred.|
LI鮮i
脇
三
|
i lDecision: Deferred.
壺
四眼覆駈
一
,
,
,
9
,
16
|
⌒
|
IHQ File
IRLA Flle
1貯淵
/4/82‐
:3
戸
i iDecision : Deferred.
| ICase No.:62/4/82‐
| IALC4/2017
||
195蘭びile‐
||
1 壌霊ガ∬∬ただ
2‐
1 1
招冊翻総
|
'Mcet No/Date:7/82-
IALC4/2017
122.ll.2017
| :
一
F
¨
Q
一
H
197
| |:01/82/050/00047/AM18/
IRLA File
iCase No。:443ノ4/82‐
IALC4/2017
|「……
19911i^■:f,
?91責0●お
1 101/82/050/00451/AM18/
~Pao Name菊
百
IMcct No/Date:7/82‐
:ALC4/2017
122.ll.2017
1Lic.No/Date:0510401830
102.032017
iStatus:Deferred.
I
l
I
a -.- _---___-"
.-"**"*
lDefer
lDate: 10.01 .2018
IPLASTICIZERS LIMITED
IRLA File
l:05/23/040/00554/AM17/
i iDecision: Deferred.
F
I
‐
o
o
iCase No。:79/4/82¨
:ALC4/2017
1HQ File
101/82/050/00087/AM18/
Pa●y Name:CROPNOSYS
I(INDlA)PRIVATE
LIMITED
‐RLA File
103/94/040/00466/AM16/
「1面ヽ而歴雨1081i611 FDefer~~~
ρ3.03.2017
Date:10.01.2018
FtteN∝“
α″82ALC″2m71wTSATYA
IMcetNo/Date:7/82‐
:ALC4/2017
ID/o Pharmaceuticals forwarded O.M.No35011/264/2012-PI(Norms)dated July 2012′
|
lυ ′V :‖ u:‖ :uし、uL=しulυ ,vl●●V●――― ― ●… … ●‐――― ―――′― ― ‐′~~~~
ミ ~
′
′
・
,
lup10aded at the end of these minutes or as apphed by the firm whicheveris less underl
lpara 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.
ICase No.:169/4/82‐
lALC4/2017
|
102 1HQ File
ParりNameiSUVEN LIFE
ISCIENCES LIMITED
1錯腎盤ザ |
画面面繭
落西
101/82/050/00177/AM18/
Declslon:Deferred.
iCase No.:442/4/82‐
IALC4/2017
ri臨漁驚蕊
RLA File
| :09 124 I 040 I 0063 4 I AM17 I
'03.032017
IDate:27.12.2017
ICase No.:299/4/82-ALC4/2017 ParりName:SUVEN LIFE Mcet No/Date:7/82- Status:
SCIENCES LIMITED
ALC4I2017
lApproved i
| 1 22.11.2017
HQ Fiiも
‐ ~ |ヽ
LAliお
‐
‐ ~ IЁ
ic`o775晨8:6う16o64ウ
`g。
さ拮i bli8:|
101/82/050/00307/AM18/ 1:09/24/040/00626/AM17/ 10303.2017 1 :
lbetitiふi l tthとこ。品品た
tさe aLcidさd i6 1atify norms based on the recommendation ofi
lD/o Pharmaceuticals forwarded O.M.No35011/559/2014-Pl(Norms)dated Apri1 2015′
|
lup10aded at the end ofthese rninutes or as apphed by the firm whicheveris less underl
lpara 4.07 of HBP Vol.1. RA concerned mayt,卜,Pec,'P'「ya't!?P''P'「
'9'l,19191NCi :
Paty Name:INDO AMINES
LIMITED
扁
IMcet No/Date:7/82‐
:ALC4/2017
122.11.2017
p6.03.2017
陛望lllttLI
|
17
^
Status:
Approved
|
:HQ File
l:01/82/050/00164/AM18/
IRLA Flle
ILic.No/Date:0910064769 1Defer Date:|
103.03.2017 1 1
:Lic.No/Date:03108H634 1Defer
:芦 糖 /4/82‐ F宵 `岬 訳PMM W『7冨赫 | | 1鷺ち刷:OЮ0613/AM17/ コ i i"'"" pHARMACEUTICALS LTD ALC4r2ori Approved l li ll22.n.zot7 lt I !___ r
L._',----l
I
tHe Fite
|RLA Firc
.No/Dategl0042989 fo-iir oate:
I
: , n. :011821050/00 I 32lAM I 8/
:3412410401003561AM17 I
07 '03 '2017
||
「HARMAC「U■CALSLTD I箸
_|
:011821050100132/AMl8/ :3412410401003561AM171 07.03.2017
I
106
'--
Decision : The Committee decided to ratify norms based on the recommendation of
:
D/o pharmaceuticals forwarded O.M. No35Ott/36/2017-Pl(Norms) dated 17th Oct. 2OL7 '
, uploaded at the end of these minutes or as applied by the firm whichever is less under
para 4.07 of HBp Vol.1. RA concerned may take necessary action as per decision of NC.
ParりName:ALEMBIC ‐MCet No/Date:7/82- Status: |
PHARMACEUTICALS LTD IALC4/2017 .Approved l
IHQ File
‐KLA rlle lし
1・・1ヽυ′ν Oし0・′41Vυ ‐44VO lν V'V・
1:01/82/050/00456/AM18/ 1:52/24/040/00084/AM17/ ρ7.03.2017 :Date:27.12.2017
jDecision : Deferred.
| ICase No.:81/4/82- Parり
NamciSAVLA
I IALC4/2017 1CHEMICALS LIMI「
7~τ墓高i石テ雨I面
而而再轟ご~~~稲
面高面ア…… 稿蔽面面
: :ALC4/2017 1CHEMICALS PVT LTD IALC4/2017 :
| ‐ 12211.2017 1
1 1従ガ∬″
848卜 [驚ざぼ酬札TD IH務満″¨υケ I………‐
| | 12211.2017 1
10810Aぉ ~IⅢ
^111::^:::.‐
~‐
~1由
`.、
6ゎieiS'ib642'6恵ibき`f~‐
・ヽ・・―′ |^‐ Aう^Al■ lno●
‐.っ71つつ011
| IALC4/2017 1CHEMICALS LIMITED
1 1
1091ごAlli:
‐
IRI.A File
1109 1HQ rile ‐
RLA File
i 101/82/050/00089/AM18/ 1:03/95/040/00939/AM17/
|
‐Case No.:90/4/82-
I ALC4/2017
File
1/82/050/00098/
獅
01漑
AM18/
18
:鱚需:L証
~壮霊澪町■ 1,Tイ■■
|
^
IP額りName:K V AROCHEM
IPVT.LTD
1銭腎盤了
No/Date:7/82-
IStatus:Deferred. |
IRLA Filc
B誰10.01.2018
|:03/94/040/01099/AM17/ 107.03.2017
101/82/050/00099/AM18/
'Decision : Deferred.
IMcetNo/Date:7/82‐
IALC4/2017
ド…恥
bК止
|
:ot.oz.zott
22.11.2017 :
ILic.No/Date:0310811677 1Defer
i
IHi従猟キ
|“慇
2¨
― 「 F I I I I I I I :01/82/050/00022/AM18/ 1:05/24/040/00622/AM17/ 臨覇 ICase No.:54/4/82¨ ALC4/2017 PartyName:SUNSHIELD MeetNo/Date:7182- | | iCHEMICALS LTD. :ALC4/2017 122.11.2017 112 1HQ File l:01/82/050/00062/AM18/ IDecision:Deferred. IMeet No/Date:7/82- IALC4/2017 122.11.2017 1面 扇 Defer Date.,21.12.2017 ICase No.:40/4/82- IALC4/2017 ,Decision : Deferred. ~騎 競評而 「 ~~開 鱚 | : H5篤艦藉L~閉瓢蕊I Deddon:Deferre止
¨
一
一
一
一
―
璽
聴酬P雨丁~
Ψ
ttra7/82-~
| IPOLYCOATS
卜7 遜こ競嚇藁正重麟数翌聖
I DecisionTDeferr灘
「
~~
19
⌒
IRLA File
l
IRLA File
i:03 /9 5 I 040 I 00964 I AM|T I
,Lic.No/Date:031081 l69l Defer Date
ρ8.03.2017
IDate:10.01.2018:
IH3面面こ
| |:01/82/050/00141/AM18/
: Deferred.
File
1;3 4 I 24 / 0 40 I 00322 I AM I 7 I
File
:01/82/050/00048/AM18/
No.:88/4/82‐
Party Name:KAlRAV
ICHEMOFARBE
INDUSTRIES LTD.
1銭腎盤了
IH6Ⅲ面百~~~~~画面直~丁~~~諄壼亜夢画面而理も
lr
|いル紗攣γ∞0?αAm ν 口%ЮttmmッAM7 p%∝2∝7
IDatc:10.01.2018
i
:棚協賛Ъ滞扁
ILIMITED
1181青
O ril`‐ 一―
RLA File
101/82/050/00162/AM18/ :09/24/040/00651/AM17/
1繭品154/4'821
1AI」
C4ノ2017
|
|||:::li::|||::|||||lilliiii:i:Fテ
iテi:i::::~~~~~″―
―
|::iliiii:iii:i!lii;i:lil:ii「
::i:lili`
|
11ぅn101/82/050/00142/AM18/ 1:08/24/040/00505
,,rro:Oll82l!5OlOOl42lAMl8l ,:0812410+t0100505/AM17/ '10'03'2017
-- .Uecision : The Committee decided to ratify norms based on the recommendation of
t,
Olo pharmaceuticals forwarded O.M. No35OtLlt38/2015-Pl(Norms) dated 37.t0.20L7 ,
i
uploaded at the end of these minutes or as applied by the firm whichever is less under
:
rpara 4.Ol of HBP Vol.1, RA concerned may take necessary action as per decision of NC
i17115[1(「
'715:[モ
IFテス
:う「
r~~――一―
|Status:Deferred.
蒻需…
|
可面評ア~~球尿繭需雨~聞霜万~器源~
lnlvtr.Vlt
t
I
I
--
I
i
122.fi.2017
I
t_..--
:HO Filさ ‐
1良LA llit 己
i`.`も
'bat816」
lo恵iittii
l:01/82/050/00063/AM18/ .:03/95/040/00931/AM17/ i1403.2017
122 Decision:丁he Commtttee declded to ratify norms based on the earlier decision taken by
iruC i1 its meeting No.U82 dated 04.04.2013 , uploaded at the end of these minutes or
las applied by the firm whichever is less under para 4'07 of HBP Vol'1' RA concerned
No.U82 dated 04.04.2013 , uploaded at the end of these minutes or
irnaytake necessary action as per decision ofNC。
「
『
| | |
20
⌒
1器獨Ⅲ鵬ATE
ILIMITED
RLA File
|:03/94/040/01106/AM17/ 114.03.2017
179913荒
10.01.2018
i
i:01/82/050/00054/AM18/
:08/24/040/00508/AM17/ 15.03.2017
堕
型
|
## Case No.:21/4/82‐
ALC4ノ2017
Parfv Name:BIOMIR
ENTURE LLP
RLA Filc
:31/83/040/00174/AM17/
IMeet No/Date:7/82-
:ALC4/2017
122.11.2017
簿tat蔦:DefettI
|
轟
l
v
l
田既:蕊嘉話」
Defer
Date:27.22.2017
ICase No。:42/4/82¨
IALC4/2017
H
T
A
”
N
D
―r品面
1
125 :HQ File
l:01/82/050/00050/AM18/
IRLA File
108/24/040/00487/AM17/
IDecision:Deferred.
1器柵器ぶ
'TH
|
RLA File
108/24/040/00474/AM17/
IZυ l器銑5υ0005 VAMlν
1 lDecision:Deferred.
,
―
― ―― ―
一―
―一
―
――――一――一
―'一―……―――
――
'
断郵F而
~琴∬
映
ferred。
1
m癬う
10064801纏≧
IDeclslon:Deferred。
駆 : ~蘊
I
ParりNameiSTYRAX
PHARMA PRIVATE
ILIMITED
IRLA File
109/24/040/00644/AM17/
21
Its.ot.zon
ICase No.:158/4/82‐
IALC4/2017
L8
1lZ° iHQ File
i
t:otttztoso/ool66/AM18/
ICase No.:444/4/82¨
IALC4/2017
IPaty Name:SUN
:PHARMACEUTICAL
IINDUSTRIES LTD.
iMeet No/Date:7182-
'IALC4l2017
122.11.2017
,status:Deferred. I
|
11291k「File
IRLA File
|
: Deferred.
「
| 1
巨犯∝7三二___L_|
1 lw繭
43033西而
|
廠洒ile~…………一一――一猥面Iile~~~~~… ……~ロト
^●
′^^′^′ ^′ ^^■^う′▲■″■0′
うИ′う月′^"^′ ^^り
,`′ Aヽ41'′
」7n
101/82/050/00133/AM18/ :34/24/040/00376/AM17/ 1703.2017 1
:Decision:丁he Commlttee declded to ratify norms based on the recommendation of
lD/o Pharmaceuticals forwarded O.M.No35011/101/2012-Pl(Norms)dated JulY 2012′
lup10aded at the end of these rninutes or as applied by the firm whicheveris less under
lpara 4.07 of HBP Vol.1.RA concerned may take necessary action as per decision of NC.
獅
「蓋濡
/4/82‐~~
r-tc*;N; |int4ic;
@FeetN"/D"t"1E1
-lst t*'D.f"-"d-
1
1 [it#;;?-""'
irNousrmes PVr' LrD' l Lc4t2ot7 i
i
r lA.Lr-r/zurl
i
li.it.ion
i
i
il33 fHa Fit;
1p1-A Ftl"
- --,t1ffi*"iooxzr io;r"' ^, *," i
I ffdlryoo.,,^*,t, l;"D;,ilt
r7l 117'03'2017 lDate:r0'01'20r8
i
I D*irt"rtr.all.u.
-*
-l
f m;N;Jrr6f-@
@
Ft t*,D.r".'"d
I
\ tx.cuzon
lrr-rjonn'ri \iliy29.t1 1
1
I lo"-''""
iiNTenNnrloNAL 122'll'2017
i
i
i,rol-
lr-rurreo
I
I
-- --l
i [ovszros0/00r-0r/AMrv [0vilrlg.:r"1ry?/ -]-rry110t? lD"t'"0'0tt'jl-
I
-_---,.1
I
| ●
11きヽま
:ζ
'′
″患ふ
~ 'att N〔
Icase No。:52/4/82‐
iParty Name:NOCIL
11361ALC4/2017
:LIMITED
IM8よヽ0/D圧じ
i7:タ
.ALC4l20l7
'.zz.tt.zotl
孵深
「
~騨驚
1全理inハnくく″ハ′
17 1青ぶら
酬
¨
|
理張I
B5田源j鳳勇鳳
「
~1語勇誌υ∞
%vA豆下~満‐
碗Ю
8118%B荒ち
7■2期7
麟蔦肩画面
『
~~II正三三正三二_
22
HQ File
:01/82/050/00060/AM18/ 103/95/040/00942/AM17/
扇高品Deferr証~~‐__ ___
RLA File
l:03/94/040/01041/AM17/
土上
F藤高面罰β年~~"NattettDDHI~~面
NoDttα782二田而亜口
: 1覚聖″2482-
: 猥■1'ダJi~~
IИ l 10iお~ ~
| |:01/82/050/00250/AM18/
I--lt*"Nriz+sfi tsi- *-liltyN.r",rNDoAMrNis'lrr,r".tN"lo"t.its2:-* -
F6t,D"f.t*e I
1 lrrc+zotz '-
ilii"i,ffi'
lntcnnon I
1
llrr
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i
i l:ov!zroro,oor,,,1*'*1l,ori31'oooto))2t^M17l 1',u-o:30"- lDate:Io'ol'20t8
]
‐Declslon:Deferred.
23
IRLA File
i
ParりNameiVIVIMED
ILABS LIMITED
1銭腎盤了
,status:Deferred. i
|
ID′ 1器島児
5υ0015ンAMlν
,RLA File
',,:09
I 24 I 040 I 00632 I AMI 7 I
:Lic.No/Date:0910064804 1Defer
ln.oz.zon
I
IDate:10.01.2018
i
lCase No.:24414182-
No/1Date:7/82‐
}38路正
~~
議
耐
TI丁
齢
飾
面
而
隆百
熱撚霧皇喘TED
lStatus:Deferred. I
1i
|:03/94/040/01H5/AM17/ 20.03.2017
IDate:27.12.2017
|
i
| ICase No.:245/4/82‐
l lALC4/2017
lParty Name:GLENMARK
IMcetNo/Dtte:7/82‐
1錯#盤了
lStatus:Deferred. 1
: |
1碗λ刷:OЮ l131/AM17/
ILic.No/Datc:0310811953‐ Defer
120.03.2017
IDate:27.12.2017 1
|
i
:Decision: Deferred.
F
I
澁
高
|「¨
felred.
ICase No.:31/4/82‐
:ALC4/2017
|
|わfNC
翻蕊鳳I
!Party Name:GOPINATH
lcusu-recH LTD.,
j
i
RLA File
:08/24/040/00512/AM17/
145
F
,
Q
一
H
―
一
~爾
漉辮戸面雨砺
'"tlUeftANT
Meet No/Date:7/82- Status:
l
r-- Case No.:2414182-ALC4l20l7 rParty Na:
r
I
GENERICS LTD
:ALC4l2Oll
lApproved
I
r
,
i
,22'11'2017
. .
-l
HQ File
nl{ f t]e
il"l)1;,l"
wJ rvavlv
:01/82/050/00032/AMl8/:051231040100604/AMl7/.2|.03.2017
146
Decision: The Committee decidJ io r.iit, no"n'based on the recommendation of
'
,
Dlopharmaceuticals forwarded o.M. No35'oLtl86l2o13-Pl(Norms) dated 29'04'20t3'
I
uploaded at the end of these minutes or as applied by the firm whichever is less under
i ;;;;;0, "i *r, Vot.1. RA concerned may take neceslry action as per decision of NC' i
| |:01/82/050/00039/AM18/
1 1bttiζ161:5もfettLal
j
iDecision : Deferred'
-
1錯∬盤了
i--ffi.;N"-44l4r82---- Fr,.rNam;pAyAL
-lM-*tN"rD"t"'Jl8, *ist"t*to"r"*.0.
1
' \x.cttzott
;PoLYPLASiii'rvnre i*C1122,t1
i
i i""::':-
ir-turrso- ;z{,ffir*rorerb.r.. -
i
!t+z yr*i1.
-i*to tr;--
lLic'
i i'ory-?/9:i/oo9r73Y3l--]lsD1gy00s'g s:!yII* -\iIoizott-]Date:I0'0I'20I8
I
1148:I〔思
`ツ標∫ユふ品蔽さ
::hittII;よ
|:::』町
1電:冒『ユ
:電∬脚』鼻
i幣
1 lndg para4.07 of HBP Vd.1.RA cOncer
24
^
IPa●y Name:CLEAN
ISCIENCE AND
'TECHNOLOGY PVToLTD.
iMeet No/Date:7182-
lStatus:Deferred.
I
:銭#鰍了
| |
:RLA File
l:31/83/040/00172/AM17/
Iに.No/Dtte:31100666301Petr
iDate: I 0.01 .201 8
:21.03.2017
「 ~ : I I
諾声剛帝価05103臨蕊覇
=一
―
一
一
一
一
一
一
―
―
―
―
一
―
―
―
―
―
一
―
J
SES PVT.LTD., 122.H.ZUlノ |
輛蕊ふ蔦声囲需繭051031
| ICase No.:130/4/82‐
1 1ALC4/2017
IParty Name:ASTRAL
ISTERITECH PVTo LTD.
INC;N"/D"I.'JE1 - -
1St 6;;D"f"*;d:
1
げ2靡i猾
1跳ち刷
:OЮ0365/AM17
: Decision:Deferred.
f- - fcu.. xo.,roiAraz:-1lqry-l,1T1crenN _-
lY::t N"/D"I"'?/8I -lst',t*'D"f"""il
\ ',ALC4nutl
ildii:Nce nNo
laLcltzotz
;
i i"-- - -- -
ITECFINOr-OC"Y pVr.lrO . 122.11'2017
,
; '
-*-'"- ---*' - * - --ilit'N"/D"t"3l1006663? P;* --
ils3 iriQ,File-
iRLA File
i
l:01/321050/001lg/AMl8i l:31/83/0a0/00180/AMl7/ lZz.Ol.ZOtl
lDate:10'01'2018
I lDecision: Deferreg. --- --
25
No/1Date:7/82-
:ALC4/2017
122.11.2017
1 lё iζこヽ3123'/4/8'1‐
‐
IParりN:語と:MAkζbN IMeet No/Date:7/82-
IStatus:Deferred。
1
| :Al」C4/2017
11551
liくぶ」sTRIES PVT LTD.:ALC4/2017
| IHQ File
IRLA File
111/24/040/00006/AM17/
i22.H.2017 __1
:Lic No/Date:1110028273‐ Defer
1 ■U1/ё Z/UDυ ′υυ∠争υ′AlVl1 0′
り3.03.2017
IDate:10.01.2018 1
: Deferred.
n
O
C
一
e
一
D
Case No。:57/4ノ82‐
F
L
ド
ー
1脚:∬
―
Mcet No/Dttα7/82- ptatuまDeたrred。
IDecision:Deferred.
158「HQ File~話蕊扁y一隔麓脱
i蔦蔦鳳
ili
|:03/95/040/00975/AM17/
IDate:10.01.2018
IDecision:Deferred.
|
[ 「要獄αIIFTl
1 1Case No.:116/4/82‐
1621ALC4/2017
1 1
26
|
IRLA File
103/95/040/00874/AM17/
i23.03.2017
IDefer
lDate:10.01.2018
|
jMeet No/Date:7182-
iALC4l20t7
i22.11.2017
lstatus:Deferred. I
ILic.No/Date:0310812042 1Defer
lzz.oz.zon
|
鵠幣普:躍Tダ‖
IMect No/Date:7/82-
lALC4/2017
'2.11.2017
‐Status:Deferred.|
iLir.No/Dute:03 I o8 1 2o4o lDefer
123.03.2017
'Date:27.12.2017 1
IMeetNo/Date:7/82‐
IALC4/2017
122.11.2017
titiヽ6/Date:0310812036 1Defer
'23.03.2017
No。:32/4/82‐
IPaty Name:GOPINATH
ICHEM―TECH LTD。
,
:RLA File
lMeet No/Date:7182-
\N-cqDott
lzz.tt.zott
ILic.No/Date:0810139940 1Defer
24.03.2017 1Date:
⌒
1麗喜勇墓藝蕉田珊面姦
|
一
―
――
―
一
―
一
―
―
~」
ICase No。:278/4/82-
IALC4/2017
Pa●y Name:ETERNIS FINE
ICHEMICALS LIMITED,
65‐HQ面ご~~~
RLA File
i:03/94/040/01151/AM17/
|:01/82/050/00286/AM18/
‐Case No.:429/4/82-
IALC4/2017
|陥瓢
鳥~ヾ
Paty NameiYASHO
IINDUSTRIES PVT.LTD.
|
lstatus: Deferred.
間瓢蔦1鳳肩
1
l-*tcr."Ni.rtoontu- "- --,p""yN;;aaAND- - rffiiN"ro"t*zrs2- - jStrtr.;o"r".i.0.
I
I itt cttzott
ipHenun LIMITED iALC4l20t'7
I
i
I i'--- --
I
l22.tt.2ot7
I
_i
i,OZ 6;r-
i*ro af,.
-----pi..NolOut.,OglO06a8aa 1O.f.t -
-i
I l;0;;r6s0l00408/AMl8/ l:oenafi+ot0o66stAMtzt lzt.ot.zort
lDate.to'ol'2018
I
I
| ICase No。:189/4/82‐
| IALC4/2017
1 1
1681鵠虚
1::蕊|;II↓lζ
~
| |―
―
―
―
― ~~ ~―
― ~ ~ ~
1 1Decision:Deferred.
ParりName:MAITHRI
IDRUGS PVT LTD
RLA File
|:09/24/040/00656/AM17/
湾蒻罰げFT
tおヽル5濃よ63お慧
i九
'§
燕fer… …
127.03.2017 1Date:10.012018
1 1Decision:Deferred.
27
1拙焦剛愉Ⅷ
1造き』別跡
tα 782‐
り2.11.2017
:Lic.No/Date:0310812082
125.03.2017
|
i
IMeet No/Date:7/82-
IALC4/2017
,2.11.2017
iParty Name:SARNA
'Mcet No/Date:7/82‐
Status:Deferred. I
ICHEMICALS PVT LTD
|
ICase No.:119/4/82‐
:ALC4/2017
ParりName:DSM
SINOCHEM
IPHARMACEUTICALS
INDIA PVT.LTD.
IRLA File
:22/24/040/00114/AM17/
漑断穏
『
而
「
~F赫
蔦
「
「総頭滞砺
10402098
|I J」
ri:
ICase No.:99/4/82-
,ALC4/2017
|ffiffr" ;Deferred.
ParけName:CAMPHOR&
IALLIED PRODUCTS
ILIMITED,
RLA File
i03/94/040/01177/AM17/
Lic.No/Date:0310812315
1.03.2017
[U..i.io" : Deferred.
IParty Name:DEEPAK
INOVOCHEM
ITECHNOLOGIES LTD
IM8Ъ :ヽ夕Date■′
j2- IStitiζ :5`feF●6:
IALC4/2017
122.112017 1
1Lic No/Date:3H0066649 1Defer
31.03 2017 1Date:10.01.2018
IRLA File
l:31/83/040/00187/AM17/
ICase No.:111/4/82‐
IALC4/2017
1751責Olilざ
一二‐
一―」
Pary Name:ELIXlR
PHARMA
IRLA File
:101/82/050/00119/AM18/
|:08/24/040/00519/AM17/
28
|
IALC4/2017
iALC4tzotT
',22.r1.20r:-
渇
3島児
5∽醐AMν
lzs.oz.zon
1170:
IMcet No/Date:7/82-
iALC4/2017
12211.2017
istatus:Deferred. i
| 1器島児
5υOm27AMlν
pO.03.2017
1魃i絡
2
7
m
¨
¨
M
e
A
L
2
2
.
Status:Deferred.
赫
|:01/82/050/00107/AM18/
i:31 183 1040100 I 84/AM I 7/
| ICase No.:276/4/82‐
1 :ALC4/2017
1 1
22.11.2017
lstatus:Deferreo. I
r41爛泉鳳ふ
1話j
i
|
I ICase No。:195/4/82‐
| IALC4/2017
1 :
1781責0卜i18~ ~ ~~ ~ ‐
: '01/82/050/00203/AM18/
|" ecision : Deferred.
11821従ガ
;∫″
9/4/82‐
Pa3/Name:ASCENT
FINECHEM PVT.LTD。
,
29
No/Date:7/82-
:ALC4/2017
12211.2017
RLA File
l:09/24/040/00683/AM17/
131.03.2017
:騰:樽ふ
::∬聞
『蹴alttf常肥部:結!∫:1出:欄Ш∬:TW轟3′
|
.
,uploaded at the end of these minutes or as applied by the firm whichever is less under
i
r
rpara 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.
.
ICase No.:322/4/82‐ ALC4/2017 ParりName:GRANULES
, INDIA LIMITED
ICase No.:202/4/82-
IALC4/2017
1猾濡“
而匿:濡僣貿多
22.11.2017
Status:Deferred.|
1791責O ril`
IRLA File
ILic.No/Date:3H0066645 1Defer
|
:j1/Oj/U4U/UUlノ//AIVllノ′
‐31.03.2017
IDate:27.12.2017 1
;
ICase No.:288/4/82-
IALC4/2017
ILIMITED
IALC4/2017
122.11.2017
Name:AARTI DRUGS IMCetNo/Date:7/82-
lstatus:Deferred.
1801負0,i`
IRLA File
; Lic.No/Date :03 I 0812327 lDefer
'Datc:10.01.2018
| 101/82/050/00296/AM18/
IUj/ソ4/U4U/UUソ′ソ/AIVll′ ′
103.04.2017
|
lCase No.:27214182-
tParty Name:AARTI
~円面高耐
|
IALC4/2017
',zz.tt.zott
1
I
IHQ File
l:01/82/050/00280/AM18/
RLA File
l:03/94/040/O H45/AM17/
脚辮細Ю
81233デ睡ち
II鳳「1
:Decision : Deferred.
需恵面1面扁
‐
|
1焉蒻蕊蕊蔦I話耳1蕊漱警
81014000'B蕩
;1:」肩
;
獅
1頭蕩需轟而百万蒻蕩瓦葛
「
ALC4/2017
22.11.2017
PaO雨:品責ELLO PAINTS
(P)LTD
蕊戸醍淵:υ00629ハm7 1翻辮α“Ю“
2146
:01/82/050/00120/AM18/
一
‐
8
5
ICase No。:275/4/82-
:ALC4/2017
RLA File
:03/94/040/01168/AM17/
,Decision : Deferred.
1
「
## Case No.:131/4/82-
ALC4/2017
F
L
F
I
ICase No.:204/4/82-
IALC4/2017
IHQ File
:01/82/050/00212/AM18/
Decision: Deferred.
## Case No.:201/4/82-
ALC4/2017
i蔦戸開誦蕊耐
p3.04.2017
|:01/82/050/00209/AM18/ 1:08/24/040/00504/AM17/ p3.04.2017 1Date:10.01.2018
江Πご卜ご高雇預面L赫
9999
Deferred.
魔儒葛丁
Lic.No/Date:0310812342
03.04.2017
Date:10.012018
Datei27.122017
P霞りName:UMA
ENTERPRISE
30
⌒
IP霞りName:CIPLA
ILIMITED.
|
|
RLA File
jParty Name:KRISHNA lMeet No/Date:7182- lStatus:Deferred.
I
IANTIOXIDANTS PVT. ,ALC4l2Ol7
|
'LTD.
122.fi.2017
:
iParty Name:PANOLI
IMcet No/Date:7/82- Status:Deferred.
INTERMEDIATES(INDIA)IALC4/2017
PVT LTD
12211.2017
IPatt Name:StlN
PHARMACEUTICAL
ilNDUSTRIES LTD.
File
:05/24/040/00655/AM17/ 103042017
2
8
7
m
¨
¨
M
e
A
L
2
2
.
i
|…貯蕊評而
「
~~椰
癬熙辮憔~ ~
「
9麗馘喜藝翼匝晒
1藁遜正
Status:Deferred。
「~|兆磁
| |
Paty NamelCENTAUR Meet No/Date:7/82‐
Status:Deferred.
PHARMACEUTICALS PVT。
IALC4/2017 1
‐LTD., 122.H.2017 1
「OM憮喜
IRLA File
:03/94/040/01134/AM17/
f-b;*N*lsaigi: ---*ip"rrvNurn.,snprecrn M*tN"loit";tnt--iSt"t,,rD.f".*d.
i
i
]ALC4IaOIT
:CEVTPHOR LIMITED :ALC4I2OI7
:
i
ti
it22.1t.2ot7it
lrer
'prq r;r,
--_|RLA r.,le
.--*ir-t.N"/D"t.or10064866 p.f"1-ll
I
l:01/82/050/00346/AMl8/ l:09t24t040t00668/AMl7/ 104.04.2017 lDate:10.01.2018 i
i iDecision:Deferred.
_---J
zz.l l.Lvt
t
'nle iii.
l-ii.Nobui.,oirosrz:27 ,Defer
:031941040100003/AM l8/
05.04.2017
Dare:2l.12'2017
ParりName:APEX IMCet No/Date:7/82‐ Status:Deferred.
PHARMA, IALC4/2017 1
1 122.11.2017 1
「
ICase No.:203/4/82‐
IALC4/2017
193に
IHQ File
IPatt Name:NAARI
IPHARMA PRIVATE
ILIMITED
~~IMCetN(
eet No/Date:7/82-
:ALC4/2017
,22.11.2017
薦
~翻PI耐
IDefer
:Oi/82/050/00211/AM18/
:Date:27.12.2017
|IDecision:Deferred。
一
‐ __師
ⅢⅢ面繭
話0ハⅢ7顧酬需繭面
|
Status: Deferred.
げ
IDate:27.12.2017
31
⌒
iCase No.:266/4/82‐
IALC4/2017
lStatus:Deferred. i
'1
「F―‐
ALC4/2017
鱚納‐
|
IHQ File lRLA File Lic.No/Date:0510402177 1DeferDate:
:01/82/050/00129/AM18/ 1:05/23/040/00617/AM17/ 106.04.2017 1
196 Decision:The Committee declded to ratify norms based on the recommendation of
lStatus:
I
,Approved
D/o Pharmaceuticals forwarded O.M. No35OLLl78gl20L5-Pl(Norms) dated Sept. 25th
2017 , uploaded at the end of these minutes or as applied by the firm whichever is less I
,under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision
i
of NC.
iPartv Name:NAiRI
PHARMA PRIVATE
ILIMITED
駆T
|:05/24/040/00003/AM18/
IMeet No/Date:7/82- IStatus:Deferred.
ALC4/2017 1
122.11.2017 1
総需縞面五死
Bttitil
Paty Name:PANERA
IBIOTEC PVT LTD.
Mi『藉
;
|
1‐
lёl:`Nよ:'"/4/8が
| :ALC4/2017
lh翻淋猿郷耐ず憔“写
一
a
s
e
」
C
一
C
A
F
な
群
―
No.:335/4/82‐
1器星掲
5υ0034νAMlν
LC4/201
Decision: Deferred.
一
一
1摯
耐t勲麓‐
ALC4/201ウ
相
゛需需
ULES
首
漱
需
燒
~1濡
濡
:
Ⅲ器3児5υ∞
"ν
Att ν 場淵iυ∞∞ν
AM ν ‐
蹴辮
C醐∞“"7:ebttα l
l lDecision:丁he Committee decided to ratify norms based on the recommendation of
l D/o Pharmaceuticals forwarded O.M.No35011/204/2017-PI(Norms)dated Novemberi
32
⌒
ICase No。:132/4/82-
ICase No.:113ノ4/82‐
腋‖ 纂
Lic.No/Date:0510402174
06.04.2017 1Date:27.12.2017
: Deferred.
iStatus:1)eferred。
|
レ2.11.2017
腔δ
ttα醐∞“舒
6
ハ
1師需需繭萬i鸞
蔦
:I FEDttHd。
随蹴
υ∞∞4ハM」
~開
辮
醐
∞
“
舒2瞬
ち7形洲
7
: IDecision:Deferred.
面雨~翻写~FT
諦硼鱚繭蹴」蕊
~
| |■
′ じい
。
・
υ i■
●ν
し■●■■■
“
●
「
貯淵7脱~
Paty Name:DEEPAK
NOVOCHEM
lTECHNOLOGIES LTD
2041百0118~ ~ ~‐ ‐
1良ニズFi18 ‐~~ ~
|:01/82/050/00115/AM18/ 1:31/83/040/00161/AM17/
IDecision:Deferred.
'
## Case No.:251/4/g2-
party Name:MAC CHEM Meet No/Dat e:7182- Status:Deferred.
' iiiitriiii
1llgP.u_cfs q\Dll) aLc4t2otz
',
i I
:PzuVnfP LIMITED
:22'll'2017
:
lru qO nr, -
i*to r* *
-
iL..N"/D"t.tr31081241? tr*--i
i
i;0i,8ii050/002s9/AMl8/ i:03te5/040t00007/AMl8/ jto.o+.zotz
iDate:10.01'2018
i
lr'"-'-----------1
i
I
l lむIζ
`ヽ
6。116J'4'患
'1 1Parり
Name:RELIANCE
I IALC4/2017 11NDUSTRIES LTD.
,7臨蕊罵ぶ
~1猾品罵
;
122.11.2017
姑ぶ辮α∝Ю
1謳
而b3而
「
~~
~ ~ ~
冨続
獅圏蕊
1ハmν
剛蕊緻戸翻卍嗣膨淵
悶
3111115磋1巌勇
FI毛兵
II~~~~~~~― ―
-1
II~IPaq而
RELIANCE W而
而
薄
33
Status: Deferred.
:Case No.:336/4/82-
| IALC4/2017
| |:01/82/050/00344/AM18/
|
IStatus:Deferred.|
:ALC4/2017
101iに ~ ~~ ~
:01/82/050/00112/AM18/
~隔5面ζ〒面雨而
丁
~~
|
珊激蕊
j蕊菰II
鰈
IMeetNo/Date:7/82-
1銭γ獄了
110.04.2017
「
|
~日
漱雷而T断
[1lilil萬1
ILic No/Date:0310812393 1Defer
tStatus:Deferred.
lDate:10.01.2018
I
il
「
―
壼
「
,Case No。:281/4/82-
:ALC4/2017
一
1淵為
ed
● ~ ~~ ~ ~ ~~ RLA Fil`~ ‐‐~~ ´
‐‐
:HQ File
i01/82/050/00289/AM 18/ 1:52/24/040/00001/AM18/
1210,Decis:on:丁he Cornrnittee decided to ratify norms based on the earlier decision taken by
i
INC in its rneeting No.2/82 dated 18.04.2013′
uploaded at the end of these rninutes or
iaS applied by the lrm whichever is less under para 4.07 of HBP Vol.1.RA concerned
irnaytake necessary actlon as per decision of NC.
rCase No.:21014182-ALC4l20l7 Parry Name:AMI LIFE
,Meet No/Date:7182- ,Status:
i
LIMITED
22,11.2017
]
uQ f ite
RLA File
Lic.No/Date:3410043 104 Defer Date: I
:0182050100218/AMl8/ :341241040100393/AMl7l :11.04-2017
)
lDecision: The Committee decided to ratify norms based on the recommendation of:
D/o Pharmaceuticals forwarded O.M. No35O1-tl825l2015-Pl(Norms) dated 01.06.2016,'
lup10aded at the end of these rninutes or as apphed by the firm whicheveris less underi
ipara +.OZ of HBP Vol.1. RA concerned may take necessary action as per decisio_n o*f 19 j
‐
‐
2
F
‐
‐
‐
‐
―
―
―
l iCase No.:333/4/82‐
| IALC4/2017
12121百0 1ile
l l:01/82/050/00341/AM18/
1 1Decision:Deferred.
IPaty Name:AUROBINDO
PHARMA LIMITED
IRLA File
:09/24/040/00665/AM17/
IMcet No/Date:7/82- IStatus:Deferred.
:ALC4/2017 1
122.11.2017 1
1Lic No/Date:0910064902 1Dcfer
IH.04.2017 1Date:27.12.2017
l lALC4/2017
′
131AO iぉ
| |:01/82/050/00223/AM18/
IParりName:CADlLA
IHEALTHCARE LTD
IRLA File
IMeet No/Date:7/82‐
IALC4/2017
122.11.2017
‐
:sta`1::bさfeFたall
|
臨
姦:
Lic.No/Date:0810140061
:08/24/040/00002/AM18/ 111.04.2017
I IIII II
34
^
: Deferred.
医謎l黙
5“慇
2‐
Paty Name:RELIANCE
INDUSTRIES LTD
:Mcet No/Date:7/82‐
:ALC4/2017
122.11.2017
:Lic.No/Datei5210042230 1
110.04.2017 1
ICase No。:257/4/82-
ALC4/2017
Party Name:MATRIX FINE
SCIENCES PVT.LTD.,
隅縣統温而'I~
1銭γ鰍了
1
石
巨
|
臨蒐扁
IHQ File lRLA File
l:01/82/050/00265/AM18/ :03/95/040/00999/AM17/
~鮮
'磁
I~
|
|
151責O ii3 ~
1:01/82/050/00130/AM18/
F
I
I
」
F
I
I
I
IParyヽ五話8:AsTRAt…
lSTERITECH PVT.LTD.
|
IRLA Rb ~~~~~
|:34/24/040/00007/AM18/
IMcet No/Date:7/82-
:AI r4/'o17
:ALC4/2017
122.11.2017
「
ICase No.:282/4/82-
IALC4/2017
2161ロハロ:1。
甲
聴
漑
需V~雰
瑠F7藤
~胃
ζ面
轟
・
陣Q Rb
|:01/82/050/00290/AM18/
| 1乙
乙・11・乙υ ■′ |
囮
話
Ltt「E漱雷繭而開而蔦
「~1頸薦~~臨
獅齋蒻湖ぎ
~Ⅸ
需肝
7/82-~
| '2H2017
| l p2.11.2017
劉7
鳳y閉脇蕊戸
Status: Deferred.
烙面1孵爵藤~冨面
鮮Ⅷ聴Ⅲ繭B競扁
Defer
Date:10.01.2018
」
‐Case No。:144/4/82¨
‐Paty Name:CAPLIN POINT
:LABORATORIES LTD,
|
脇蕊蕊鶉
′
Paty Namc:FINE ORGANIC
IINDUSTRIES PVT.LTD.
1鷺λ刷:OЮ0014/AMlν
一
2
‐
9
IALC4/2017
|
Status:Deferred。
|
35
「
IDecision:Deferred.
122.11.2017
| |むよ品
‐
ヽも
::うウ
1/4/82-
12201ALC4/2017
| 1器島児
5υ00279ハMlν
'
tDecision: Deferred.
Party Name:GRANULES
靡
: Deferred.
ICase No.:254/4/82‐ IPc
:AI r4/'o17 11ヽ
IALC4/2017
Party Name:PIDILITE
INDUSTRIES LIMITED
IHQ File ‐RLA File
:01/82/050/00262/AM18/ 1:03/95/040/00125/AM16/
,Decision : Deferred.
F
L
F
I
ICase No。:280/4/82-
:ALC4/2017
IP冨りNameiCLEAN
iSCIENCE AND
|
ITECHNOLOGY PVT.LTD.
iCase No。:220/4/82‐ALC4/2017 Paty Name:HONEST BIO―
|
澁
扁戸
VET PVT.LTD
IRLA File
:08/24/040/00005/AM18/
D/o pharmaceuticals forwarded O.M. No35OLtlL22l2014-Pl(Norms) dated Oct.2OL4,
uploaded at the end of these minutes or as applied by the firm whichever is less under
.para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.
l
36
⌒
ParりName:GODAVARI
IDRUGS LTD
IMeet No/Date:7/82‐
lALC4/2017
122.11.2017
IRLA Flle
1腎ざ
l鶏彎α
0910064920B鳶ち
7.12.20171
|
iRLA File
|:υ 1/OZ/υ ′υ′υυDDD′ AlVl1 0′
Party Name:RHODIA
SPECIALTY CHEMICALS IALC4/2017
11304.2017
燈:淵να
782
IRLA File
|:31/83/040/00001/AM18/ 117.04.2017
:Date:10.01.2018
IALC4/2017
122.11.2017
ILic.No/Date:0810140093 1Defer Date:
11704.2017 1
|
「 ~~ 瓢
| IALC4/2017
, Case No.:255/4/82-
lParty Name:OM
ITNmncoNTTNENTAL
RLA File ~~
|:03/95/040/00025/AM18/
F
独
F
I
y
剛調続脇
17
F;trilr, D.f....d"
F翻暉
~「満赫‐
話戸
~聞
辮而Ю
812525
l lν
じし■Siυ
・■●V●■じユニじuo
37
^
: iCasc No.:253/4/82-
| 'ALC4/2017
| 1鷺
=鷺
INamelMETROPOLITAN
IEXIMCHEM PRIVATE
ILTD.
IRLA File
IMcet No/Date:7/82‐
IALC4/2017
12211.2017
iStatus:Deferred.
I
iillri
iLic.No/Date:05 I 0402238 iDefer
18.04.2017
IHQ File
: :01/82/050/00263/AM18/
: Deferred.
IMcet No/Date:7/82-
IALC4/2017
122.11.2017
:山
…
1
1蹴辮α∞ЮЫ%“
:貯∬“脱‐
押∬鰐L器刑獣諄猟T纂
lStatus:Deferred.
I
it
子
jUI器星児
5α003Иハ
Mlν
:RLA File
11804.2017
| IDecision:Deferred.
獅
…………・― …………
…
■而耐万
"
|:03/95/040/00029/AM18/
118.04.2017
IDate:10.01.2018 1
|
Defer
Date:21.12.2017
li6うおお50/00326/AM18/ 1:あら
4応スo/ooo12/AM18/ 119.o4.2017 1 1
35 15ttisibi‐ :十Aと
~こ
6丼|1llttとき
‐
しきさ
iaさb ib l:iifyムふ
「11:ら:ζさa6hiムと
,さ[6品語とム
b`116A31i
D/o Pharmaceuticals forwarded O.M.No35011/737/2017-PI(Norms)dated Novemberi
12017′ uploaded at the end ofthese rninutes or as apphed by the firm whiCheverislessi
lunder para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decisioni
lof NC. :
[ - Ier."xo.,irs4l82-Al
'Ciniiti fpu.ryNur.,oncH - irrr..tNolDate:7la- fst't^;
*
!
' I
I-ro
Q2.ll'2017
'
i
I iro File
:RIA Fil;
Li..Norout":obTiloo+q:o -lp.r.iout.'
I
l
l..riroorn<n/^n21(/art,rre/ l.norla.ntonool?/AMl8/ 119.04.2017
i
i
iDecision:Deferred.
| |りじじISIUllこ
ν じ■じユニじ
…
1_:三
二
三
二
二
______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
一
―
一
一
[-1c"." xo;,Zt4uit82. - - lp"rty N"*"*elrnN-cE - M".tNi"to^t"ngT- F**o"]".*0. i
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lrNousrrues LTD.
iALC4t20t7 I
1
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lzz.tt.zon l_.- * _ i
lzlz'1nqr1.
IRLAFiG
ll[.N.iD.C'o:rosl26oelD.f.l-. -.:
i
I l;;;AOn*ytyfrl l,iliirilr,rcrootLnr'arzr liq.o4.2ot7 __.-- lout"'to.ot.zott
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irNousrruEs LrD lii?i::,tl
i
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lrrt it q.tn
--- -*tr^ ril" -
{L[.N./ffi*13r004s6041ff";--- -i
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i'':r::tt ggttt -i
i
-
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壼
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Ⅲ中111
語璃
Ⅲ
僣
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薇ふ善
可
i iCaseNo.:265/4/82‐ 11
L9[Wh_壁赫h脇鰤 |
2017 1
-―一― ― - 1_.‐ ′^.^^■AO■^ι =●島萬L=: ~~~
|"識聯通轟正臨賑面高正重蘊霊
=壼翻
FI鸞酔轟藝
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0638ハm7け調
器α
“Ю
似
"
^
r :0 1/82/050/0030 I /AM I 8/
i
38
1画面可Deferred.
ILIMITED
IALC4/2017
22.11.2017
~雛
蕊評
/82‐ ~~~
|
2411HQ~File…… ~~~~~‐
Ю1/82/050/00347/AM18/
F
L
F
I
1 1こ:きざヽ
&:ig患/4/患う」 ||五お`温まIRl'i… …
M`まヽルDat&ウ′恵ふ ‐…も
I五高さ
ib`おFied:~:
'3鮮
11~~__、1蝉世_葺鷲鳳二ご=
孵璃評而
I‐~~~
臨温麗薦戸
IPatt Name:PRIⅥ
lORGANICS INDIA
ILIMITED
開聴話蕊」扁
IDecision:Deferred。
冊蕊蕊i戸`
隔蕊~~~Ⅲ
迎翌電臨温]
)5/040/00040/AM18/ 121.04.201
冊蕊蕊戸`
隔蕊蔦繹yⅧが
要“
B鳶
:だ嘔
瞬悪高F藻面高ご~~ ~
一
2
一
渇
一
4
一
7
一
a
s
e
N
o
・
‥
2
‐
¨
一
C
A
IHQ File
l:01/82/050/00225/AM18/
IDeclslon:]Deferred.
rcase No.:3e 4t4t82-ALC4"o" ]lIHJfi,fSJis,Bi,xtT, ix;:,rxDat'1 t82' lifiH;* i
iHq iif.
'RLA Fil"
Lic.No/Date:0910064943 ,Defer Date:
l
.:01-l82lOs0/00402/AMl8/ :091241040100015/AM18/ 24.04'2017
245 Decision : The Committee decided to ratify norms based on the recommendation of
:
'1Df o pharmaceuticals forwarded vide O.M. No3501U72/2OL4-P|(Norms) dated,
,21.04.2014 , uploaded at the end of these minutes or as applied by the firm whichever is I
,
iless under para 4.O7 of HBP Vol.1. RA concerned may take necessary action as per
decision of NC.
阿
瓢
需
滞
~
IRLA File~~~~~~~―
――一一―
105/24/040/00026/AM18/
M`giヽ。わ:i`:ケ′
jう1 ‐
11lti::58ユIledl
:ALC4/2017 1 1
39
ヘ
1
No.:392/4/82-
No/Date:7/82-
lstatus:Deferred.
,
| |
P40陣Q Fue lRLA Fib ~~~~~~~に
た。No/Dttα0310812669Deir
121.04.2017
iDate:10.01.2018 i
,i
jDecision: Deferred.
IPa●y Name:NIFTY LABS Mect No/Date:7/82‐
IPVT LTD., lALC4/2017
IRLA File
l:09/24/040/00695/AM17/
Status:Deferred.|
IDefer
Mcet No/Datei7/82‐
IALC4/2017
122.11.2017
ILic.No/Date:0310812667 1Defer
121_04_2017 1Datel10.01.2018
…
甲渕耐~孵吻l
%圏
50/0027鳳話~瓢
鳳
Decヽbn:DeLrred。
~~~
F
L
F
I
ICase No.:264/4/82‐
IALC4/2017
翻馘扁
Paty Name:DELTA
FINOCHEM PVT LTD.
.RLA File
103/94/040/01082/AM17/
Lic No/Date:031081
24.04.2017
F
I
I
I
L
に
―
―
―
―
Date:27.12.2017
脇
高庶蔦戸
1蹴辮α“ЮЫ
2683囲
i.I瓦再
脚
09100649511諏蕩iT:葛
「
Case No。:342/4/82‐
ALC4/2017
Pa●y Name:HETERO LABS
LIMITED
RLA File
l:09/24/040/00038/AM18/
議調器α
"Ю“の"
|:lしヽ五ふ8:HoヽouNLAЁ
~
LIMITED
iRLA File
l:09/24/040/00035/AM18/
⌒
諄‖ 纂
Name:ELPPE
IMeet No/Date:7/82-
IStatus:Deferred。
‐
|
一
一
二
|
ParりName:ELPPE
CHEMICALS PRIVATE
LIMITED
IRLA File
2501責OFilも
――
「
爾
需瀞
面戸~~町
需F面
面慧F顧
覆
『
し
:"恵メ
Fmm劇・
|
′5110由ぉ~~
1 1:01/82/050/00351/AM18/
|
12521
l iHQFll,
40
53日蒲雨~~~~~~~`
:01/82/050/00389/AM18/
IPatt Name:KRISIINA
:ANT10XIDANTS PVT.
ILTD.
r :Decision: Deferred.
:
12
Decision: Deferred.
Meet No/Date:7/82‐
Status悪再red:~
ALC4/2017
22.11.2017
囲配戸0005函睡鷲蔦
F
I
』
F
I
## Case No.:381/4ノ82‐
ICase No.:346/4/82-
IALC4ノ
2017
S
B
A
M
L
E
D
A
T
図
‐
M
‐
C
,
L
N
a
m
A
T
E
一
切
即
謗鮒酬秘Status:Deferred.
255
:RLA Rb
:09/24/040/00699/AM17/
lii"N;D"t.09 I 0064% i iD.f*-
izq.oq.zon
;Date:27.12.2017
%6鵬泥
5∽鯰舒′
蔦
甲
濡
温
蕊
~翻
暉
…
1温
DeferredI
Mil絣.y一一課爾麗密〒画面面百万
E鴛現
:瓦肩
7~
ICase No。:279/4/82‐
IALC4/2017
,
rDecision: Deferred.
甲麒=
%7露g島膠
11蔦蔦
「
~~焉
霧蒻語篤鳥湛ふ説鳳罵
7……
lMeet No/Date:7182-
]ALC4l2OrT
i22.11.20t7
I-
-
"
-
lLic.No/Date :09 1 0064960
I
t25.04.2017
l
,Case No.:38314182-
:ALC4l20l7
蔦蔦
P".ty Nil;'tfPPf
CHEMICALS PRIVATE
ILIMITED
103/94/040/00066/AM18/
翻肝画面田蔦~
Status:Deferred.
ALC4/2017
22.11.2017
IDecision:Deferred.
Paty Name:ENCUBE
IETHICALS PVT LTD
IMeet No/Date:7/82-
IALC4/2017
22.11.2017
Status:Deferred.
: ICase No.:373/4/82‐
12591ALC4/2017
|
41
1銭#盤了 |
IRLA File
Lic.No/Date:0310812680 1Defer
124.042017
‐Date:10.01.2018
| :Decision:Deferred.
|
Status:Deferred.
――
―
――
|
g:清ち
7■22∝71
| IDecision:Deferred.
鱚
j蕊萬点
1嵩
嬬需血127881濡
1ち鶏
iStatus:lDeferred。
腋‖¨ 拌¨
Lic.No/Date:5210042240
25.04.2017
IDecision:Deferr'ed.
´
「霊濡で
「
1 1
1 1ハ
ユ」`・●
“
υ 量′
1 1
:62鳥3島鬼
::1温:1↓lj
l l
―
―
―
―
―
―
―
i lDecision:Deferred.
Paty Name:FINE
10RGANIC INDUSTRIES, 顔‖"
Lic.No/Date:0410163028
25.04.2017
~孵渕
2631uハr:1^~~
HQ File
:01/82/050/00385/AM18/
一
一
Pa●y Name:GUJARAT
:∩p^Aヽ
1lρ Q I IヽガIT口n
10RGANICS LIMITED
IRLA File
103/94/040/00087/AM18/
IDecision:Deferred。
……
lcaseヽこ
:う而Й
'82-
IALC4/2017
%4:_____
IPany
lName:METROPOLITAN
IEXIMCHEM PRIVATE
IHQ File
l:01/82/050/00248/AM18/
:LTD.
IRLA Filc
:03/95/040/00019/AM18/
Lic.No/Date:0310812806
26.04.2017
:317/4ノ82-ALC4/2017
0
一
N
一
a
匿
―
―
一
lStatus:
iApproved
HQ File
:01/82/050/00325/AM18/
Dlo Pharmaceuticals forwarded vide O.M. No35011/110l2OL7-Pl(Norms) dated
Ъち刷:0/00556/AM17/
‐
琵静嶽奮
面而両″
^
42
luq nite
Pa“y Name:SUPREET
iCHEMICALS PVT.LTD.
IRLA File
IRLA File
126.04.2017
1錯γ鰍了 |
津“
|
November 2017, uploaded at
whichever is less under para
the end of these
4.07 of HBP Vol.1.
minutes or as
RA concerned
applied by
may take
the firm
necessary
raction as per decision of NC.
声
淋
P・
~´
I IVAL~
叩
7/82‐
IStatllS:I) eferred. |
1翻器α“Ю
812810B鮨
10劇2∝8
HQ Filc
:01/82/050/00258/AM18/
「
1
1
「
壺
嘱従胤″
9た/82-
・瓢
、高;蕊
F
‐
‐
‐
‐
‐
2
‐
‐
‐
‐
‐
ParりName:V.D.H.
10RGANICS PVTo LTD
IRLA File
:05/24/040/00030/AM18/
Decision: Deferred.
師
~
1蔦
~~解
輛欝膏雨面薇所閉Iふ;「
―
―
¨
―一一――――
―一――
―――一――――― ― ――一――――――――――一―――――
―――― ―――」
1272 1Case No.:329/4/82‐ALC4/2017 1Party Name:ORCH IMcct No/Date:7/82-
Status:
43
i
jDecision : Deferred.
Status:Deferred.:
|
2
7
D
a
‐
7
7
e
t
N
。
/
m
‐
‐
・2
0
‐
M
e
A
L
2
2
.
Pa●y Name:DELTA
FINOCHEM PVT.LTD.
1 狂憂´三
999387AM18/
IRLA File
103/94/040/00026/AM18/
27.04.2017
File
1 lDefer
'Date:27.12.2017 i
| IDecision:Deferred.
1 猥従胤∬
048年
| |
:訛器洲缶
D.
| ‐Decision:Deferred。
LABORATORIESINDlA PVT IALC4/2017
IHQ File lRLA File
:01/82/050/00337/AM18/ :09/24/040/00033/AM18/
:22.11.2017
LiciNo/Datよ09‐ioo64979
77.04.2017
[,!百11illlilill「
1:il:::idil:at:I卜lirT:蜻iル11。,1:lili11:罵lat:h∬
__ _:__ __J _r iL^_^ _:…
…ι^^ ^_ ^´ ^^^::^月 L、,■kA ■′い
lNovember 20L7, uploaded at the end of these minutes or as applied by the firm
lwhichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary
laCtiOnasperdecisionofNC.
1
D/o Pharmaceuticals forwarded vide O.M. No3501U1LOl2OL7-Pl(Norms) dated Oct.
z1th ZOL7., uploaded at the end of these minutes or as applied by the firm whichever is
under para 4.07 of HBP Vol.l. RA concerned may take necessary action as per
n ofNC.
摯
“
`二■0/4/8'ILC″昴it轟`岳6°RCま……………
Ⅲ語`J面よ力
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bi“あ商
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273
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17紗~
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22.11.2017
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一―
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--infa nG-'-**-- ---'--iit.n"/D"i;;03108nelt
:01/821050/0024glAMl8l 1:031951040100035/AMl8/ 27.04.2017
Party Name:PRIVI
Case No。:238/4/82‐
F
L
π
l
Party NameiSI GROUP¨
INDIA PRIVATE LIMITED
HQ Filc
:01/82/050/00246/AM18/
:03/95/040/00032/AM18/
rRLA File
;:03195104(
iCaseNo.:208/4/82‐
:ALC4/2017
1
Party NameiSTERILE INDIA
Meet No/Date:7/82‐
IPRIVATE LIMITED
ALC4/2017
:
122.11.2017
″
1鮮出す
1111■日路螺
'li牽`躍
竺|II:責
'す
∵
=
File
\:os Da / 0a0 / 00036/AM I 8/
: Deferred.
44
i-rr-*-----
---r
I
lHe File
IRLA Fl. -
- -E[.N"/D"tro8l0l40l?9 m*
-_-
i
I l:0t/82los0/00416/AMl8/ l:08Dafi40100016/AMl8/ tzt.ot.zotl
lDate:27.r2.20r7
|
I lD;ti'.d, D.f.T.g._
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Nur.*efffeR - -ll\4*t N"/D;t"'?/82 IStrt,*O"f..*0.
I
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TINDUSTRTES LTMTTED lALC4t20t7
|
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_iol!1zt,tzz]ofi
1,
I -U:!,"l.f-*"""d"
-
____-l
,Case No。:331/4/82¨
:ALC4/2017
1
猛
33月5ν∞
"りAMν
Party Name:AUROBINDO Meet No/Date:l182-
「
書X高
貰Ⅷ
悩
;Nυ
υ
顔
弾
猟
了
瓢
蕊i鳳:1~爾~g面
01.05.2017
| :ALC4/2017 1NOVOCHEM
ITECHNOLOGIES LTD
i.ol r_
'ltuHNULUUllr,SLlD
:22,llj2017
l_l
[urlHaFite
trAFl.
---@iD"f.,
-l
I L0]i84ry90150/AMl8/ i:3t/83t040/0001o/AMl8/ i01.0s.2017
loate:to,ot zota
I
]__]Pg.IIl; D"_f**il
--- ---
_- I
|
Defer
Datei27.12.2017
| ICase No.:142/4/82- IParりName:DEEPAK I
I :ALC4/2017 1NOVOCHEM
ノ
ITECHNOLOGIES LTD ,
「 :
2831責O Fi8 ~ ~ ~ lkLA「ilし~~ ~ ‐
|:01/82/050/00149/AM18/ 1:31/83/040/00012/AM18/
Decision: Deferred.
O.ci.ior, , P.f....d-
/82‐ P満而
|
45
1279
rStatus:Deferred.
i
|
B鳶ち
7.12.20171
,
:拙譜T艘繋どM性き淵να
782
ILIMITED
り2.11.2017
‐RLA File
「…
欝辮
4/4/82‐
「
4
l~
PaおNahよtiЁRNIS i`Ё‐
IMeよヽ
b′b品レ82: ~もi:品まbefe拝
`工
|
ICHEMICALS LIMITED, :ALC4/2017
: 122.11.2017
翫蕊蕩蒜蔦私話丁
~ B施
10.01.2018
i
:01/82/050/00384/AM18/
103/94/040/00099/AM18/
1蹴辮α“Ю脚"PebDtte
103.05.2017
lby NC in its meeting No.19/82 dated O2.OL.2OL4, uploaded at the end of these minutes
lυ γ :`し::::LD:‖ じじL::16:`υ・ユフノ04 uoしcu υ 4.υ ユ.4υ 工"′ uPIυ duCu aL L::じ
じ::uυ :L:iC)●
::::::uLじ
:
10r aS applied by the nrm whicheverisless under para 4.07 of HBP Vol.1.RA concerned
i:may take necessary action as per decision of NC.
‐ALC4/2017甲
鶉
声
´
鱚
万
~町
Pa●y Name:HETERO LABS
:LIMITED
H
Q
山
1/82/050/00327/AM18/
IRLA File
:09/24/040/00069/AM18/
「W¨ 而甲闊… 諄鮒~町
1 1口∩口:1。~……………………………… 下高高獅。 ~~~~~~~~~I:ρ 、inノn●|●・nolnnκくnnA : ~
IHQ File lRLA File lLic.No/Date:0910065000 1
101/82/050/00336/AM18/ :09/24/040/00070/AM18/ 103.05.2017 1
1Decision:The Committee decided to ratify norms based on the recommendation of
I D/o Pharmaceuticals forwarded ude O.M.No.35011/80/2010‐
Pl(Norms)dated
1 101.10.2010 as under:
′
881
Export ltem
lmport ltem
Qtv. Recommended kg/ke.
(2R― CIS)-5‐ (4‐AMINO‐ 1′ 2-
DIHYDRO-2-OXO-1-
PYRIM:DNYL)-1′ 3-
OXATH10LANE-2-
CARBOXYLIC AC:D(2S′ 5R)―
MEttHYL ESTER.
GLYOXALIC ACID
0.73
SODIUM BiSULPHITE
0.637
2′ 5 DIHYDROXY-1′ 4-
DIEttHANE
0.344
TRIETHYL AMINE
0.034
DI MEttHYL FORMAR/1:DE
0.23
46
⌒
iCase No。:219/4/82‐
:ALC4/2017
1銭γ盤ザ |
ParりName:PIINDUSTRIES IMeet No/Date:7/82‐ IStatus:Deferred.
ILTD
IHQ File
IRLA File
ILic.No/Date:1310048617 1Defer
i02.05.2017 1Date:10.01.2018
File
'286
: The Committee decided to ratify norms based on the earlier decision taken
|
|
1287
ICase No。:319/4/82-
lALC4/2017
:Mect No/Date:7/82‐
IStatus:1)eferred。
|
ILic.No/Date:0910065001 1Defer i
103.05.2017
IDate:27.12.20171
|
HEXA MEttHYL DI
SILIZANE
0.75
MEttHANE SULPHONIC
ACID O.01
0.01
CY‐「OSINE
0.455
丁OLUENE
1.82
N―HEXANE
3.00
MEttHYLENE D!
CHLORIDE
2.03
RA concerned may take necessary action as per decision of NC.
=
=
―
―
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濃
F
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F
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IVυ :Yイ・´
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I lALC4t20t7
ISoLVENTS LTD.
IALC4/20t7 ,
i
i^^.;
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l22.tt.2ot7
,
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t, l:011821050100231/AMl8/ ;05124/040/00025/AMl8/ lO:.os.zOtz
lDate:10.01.2018
i
I lfii.ir" io.t "*0"
- -- I
~F而
而
磁‐LC42∝7扉
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漑
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| |
lzz.tt.z_on_
IHQ File lRLA File Lic.No/Datc:0810140231
101/82/050/00358/AM18/ :08/24/040/00017/AM18/ 104.05.2017
|
PttNamαHKAL
292 Decision:丁he Committee decided to ratify norms based on the recommendation of
l D/o Pharmaceuticals forwarded 宙de O.M.No.35011/40/2017-PI(Norms)dated
l 108.11.2017′ uploaded atthe end Ofthese m:nutes or as applled by the nrm whichever:s
師
‐~
|
…
…
:
| leSS under para 4.07 of HBP vOI.1. RA concerned may take necessary action as per
ldecision of NC.
匹匡瓦而薇
47
⌒
Paty Name:HETERO LABS IMcet No/Date:7/82-
:LIMITED
tALC412017
izz.tt.zon
IRLA File
:03.05.2017
[~~IALC4/2017
翠隧
1蔦
ILIMITED
|
IRLA File
:03/94/040/00078/AM18/
1錯γ鶴7 ~|
'Decision : Deferred.
Paty Name:NATURAL&
:ESSENTIAL OILS
IPVT LTD.,
1鶴ち刷:OЮ0012ハMlν
Decision: Deferred.
援従枷″ン″秘
Party Name:JUBILANT
ILIFE SCIENCES LIMITED
IMect No/Date:7/82‐
|
2971
|
HQ File
|:01/82/050/00221/AM18/
IRLA Flle
l:05/23/040/00630/AM17/
| IDecision:Deferred。
: 壌壺脇1庁だ池: ~ :獣蕊1かふぎ
| : |
181鍮輛11普ⅢⅢⅢⅢ
[-|ffi;N* rzfuilml- --ip"rtyNur*'ieirfo
1v..illofout lft2- -is"tr"o.r....o-
1
i E;Aoir- --
1INDUSTzuES PVr.LrD. 'iALC4t20t7 i
i
ll
rl22.tt.2ot7
ll
lzee i*.*
RLA F1;-
-
-[i..N"1o"t.tr310813142lGr* --t
I
I,oilsztos0/00268/AMl8/ l:$t9sfia0fi0097/AMl8/ loe.os.zotz
iDate:10.01.2018
I
t:--
i
-
i
1孵寧…
冨写
翻卍赫臨扁
:ALC4/2017
22.11.2017
48
2
8
4
8
N
O
・‥4
7
如
a
s
e
L
C
C
A
Fフ′
1器島児
5υ0048αAMlν
: Deferred.
.Status: Deferred.
| |
:Lic.No/Date:0510402482 1Defer
IDate:10.01.2018 1
「
iCase No.:2/4/82‐ ALC4/2017
:01/82/050/00010/AM18/
IBIOSCIENCE LIMITED
IRLA Fllc
:52/24/040/00007/AM18/
ALC4/2017
22.11.2017
呼
/o pharmaceuticals forwarded O.M. No.35}LL/468/2014-Pl(Norms) dated Feb. 2015 ,
ploaded at the end of these minutes or as applied by the firm whichever is less under
ara 4.O7 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.
Lic.No/Date:0810140277
11.05.2017
Party Name:DHANUKA
LABORATORIES LTD.
蔦
p2.11.2017
i
Pa■y Name:KAIRAV
ICHEMOFARBE
INDUSTRIES LTD.
## Case No.:369/4/82‐
面
眈
1/4/82‐ 逓
れm7耶
判
EPHARMA
|
IMeet No/Date:7/82-
IALC4/2017
12211.2017
F五
石面藻蔦蔦J
IRLA Filc
109/24/040/00084/AM18/
49
菫り… 1図;~
IApproved
IHQ File
1貯腑
5/4/82‐
Paty NameiCADILA
IHEALTHCARE LTD
謗‖~
Defer i
lDate:2712.2017 1
|
| |:01/82/050/00303/AM18/
I
:
^
υ
諄鮒纂
1碗λ刷:OЮ0098ハMlν
ILた。No/Date:0310813193 1Detr
111.05.2017
IDatel10.01.2018
i
|
Pa●y Name:KAIRAV
iCHEMOFARBE
INDUSTRIES LTD.
監き棚ッα
782
'2.11.2017
:m…
di
IRLA Filc
1.05.2017
IDefer
iDate:10.01.2018
IDecision:Deferred.
1305:責O ilも
1
## Case No.:430/4/82‐
Paty Name:PRASOL
ICHEMICALS LIMITED
RLA File
:03/95/040/00063/AM18/
Defer
Date: 10.01 .201 8
Lic.No/Date:0310813187
111.05.2017
iDAtr6r: Deferred.
瓢鳳蕊鳥蔦戸
~日
飛頭需冨聯画面万
ICase No.:367/4/82¨
IALC4/2017
HQ File
:01/82/050/00375/AM18/
匿
I
A
I
一
ase No.:349/4/82‐
LC4/2017
ParりName:ENCEE
.AROMATICS PVT.
ILIMITED
RLA File
:32/24/040/00001/AM18/
|,夕Fl髪l了
巧
;1わ・
~~~…
11爵
IS:Deferred。
期鵬鳳扁
♭2H2017 1
癬辮“飢∞画開蕊薦
Date:27.122017
IDecision:Deferred。
Ⅲ開
開脇脇話し
50
IMeet No/Date:7/82-
lALC4/2017
:22.11.2017
Status: Deferred.
|
1貯脚И脱‐
Status:Deferred.
,
1307 ,HQ File
1露翌型型里
r lDecision: Deferred.
Paty Namc:CLARIANT
INDIA LIMITED
No/Date:7/82-
IALC4/2017
122.11.2017
1鷺λ
ttiOЮ0117/AMlν
: Deferred.
「
障五源籠口薇F~~~F繭
繭
面FΨ
漱
繭
正
~F嘉而
而
督
1鷺λ馴
:0/ooo62/AM18/
22.11.2017 1 1
B鮨10.01.20181
I lDecision : Deferred.
| ICase No.:287/4/82‐ IPar″ Name:ARJUN IMeet No/Date:7/82-
| IALC4/2017 1CHEMICALS PVT LTD IALC4/2017
怒tatush而¬
|
,2.11.2017
|
「ぽに~憚
甲薦翻 胃面扇面
1
PVT LTD 122.11.2
l:rz 1r*,n
IRLA File
lLi".No/Dute:34 I 0043 I 75 iDefer
| |:6):ダる
50/00417/AM18/ 1:34/24/040/00017/AM18/ 116.05.2017
I
IDate:10.01.2018 1
|
3131古Ori18
:01/82/01
:01/82/050/00411/AM18/
RLA File
:05/23/040/00029/AM18/
1吻罰510402566臨蔦
Declslon:Deferred.
「
|
:Deferred.
|
:Lic.No/Date:0510402586 1Defer
16.05.2017 1Date:27.12.2017
劉
41面百~~戸
囮
蕊1鳳|
| |:01/82/050/00415/AM18/
‐Decision:Deferred.
IMcet No/Date:7/82-
lALC4/2017
122.11.2017
IStatus:Deferred.
ILic.No/Date:0310813301
116.05.2017
i,oilii6so,o03es/AMl8/ l:$Darcaorcollo/AMl8/
I
1器星泥
5υ00427AMly 賠た男
:OЮ063αAM17
## Case No.:415/4/82-
,
ALC4l20l1
lztg,
:HQ File
101/82/050/00423/AM18/
51
^
,2.11.2017
ICase No.:386/4/82-
‐ALC4/2017
1臨聴
αNDO AMNES匿
き∬
α7紗‐
Status:Deferred.:
'22.11.2017
File
Q
・
H
^
IRLA File
l:03/94/040/00095/AM18/
Lic.No/Date:0310813306,Defer
Date:10.01.2018 i
16.05.2017
I lDecision : Deferred.
缶
6
:~ν
'V` |
IDate:10.01.2018 1
I lDecision : Deferred.
1 1Case No。:395/4/82…
鰐
濡
:10DAS EXPα
M眠
棚
ツ
α7慇ν
: :ALC4/2017
1 1
F口1器島児
5υ0040νAMlν
IRLA File
116.05.2017
IDate:27.12.2017:
| IDecision:Deferred.
|
llic.No/Date:05 I 0402584 iDefer
116.05.2017
:Date:10.01.2018
| IDecision:Deferred.
lriSα ENCESuM「ED i什
γ 織了
22.11.2017
iStatus:Deferred.|
: |
IRLA File
lticiヽ。
/Date:0510402583 1Defer
:U)/Zj/U4U/UU01'ノAlVll′ ′
116.05.2017
IDatel1 0 01.2018
IDecision:Deferred.
1器3泥50Ю0473晨Mlν
障危刷:OЮ0282ルヽM17
Mcet No/Date:7/82‐
ALC4/2017
22.11.2017
科激
u∬Dettre止
|
開荒蔦
~
ICase No.:465/4/82-
Paty Name:UNIVERSAL
ICHEMICALS AND
INDUSTRIES PVT
ILIMITED
田N 「
~~~
国Ⅲe
RLA File
|:01/82/050/00393/AM18/
:03/94/040/00090/AM18/
IDeclslon:]Deferred.
F
L
F
I
M18/
iMeet No/Date:7182-
,ALC4t20t7
lzz.tt.zon
1悧器α
tt Ю““の
B府1。m2∝8
臨紗綱耐
|
Paty Name:CLEAN
iSCIENCE AND
ITECHNOLOGY PVToLTD.
F
L
ド
ー
ICase No.:393/4/82‐
IALC4/2017
IHQ File
l:01/82/050/00401/AM18/
ParりName:CLEAN
iSCIENCE AND
ITECHNOLOGY PVT.LTD.
RLA Flle
|:31/83/040/00026/AM18/
IMeet No/Date:7/82‐
ALC4/2017
22.11.2017
Decision : Deferred.~Ⅳ酬~
蒸|ド開臨高iド
蕩漁
一
7
一
〇
2
一
″
一
C
一
L
一
A
一
8
2
一
4
一
2
一
1
一
4
一
〇
,
N
一
a
一
C
隔
ド
52
ICase No.:431/4/82-
:ALC4/2017
|
秤江眠Dettrea
l
i
|
2
8
7
¨
¨
¨
M
e
A
L
2
2
.
IHQ File
1鷺λ
ttiO/00135/AM18/
IALC4/2017
122.11.2017
117.05.2017
|
|
IRLA File
i31/83/040/00025/AM18/
IStatus:Deferred.|
ILic.No/Date:31
:Date:10.01.2018
,Status: Deferred. ,
i
IMcet No/Date:7/82¨
LA liお~ ‐ ltilヽ6′5:18:341oo4ji"|‐
~… ……
1綿島憶
:j:li」jl↓ij 義
/2″04υ00047AMly l&α 5.2017 :
,Case No.:351/4/82¨ ParりNameiBIO TE
:ALC4/2017 .OPHTHALMICS P`
| |
切
Lm y
隔蔦画面票
「
1 1従 胤 ∬ ν″秘 {的 Namα Ы O TECH vは NυDatα7' Sttuま Deたrd OPHTHALMICS PVT LTD IALC4/2017 1 Status:Deferre d. ICase No.:368/4/82‐ lALC4/2017 | 熙聯平 ~ 2‐ 胃赫 i:i::| 3291責OFilも~~~ ‐~ | :01/82/050/00376/AM18/ 1 1Deciti。1:Dおferled. | ― 一一―…………… 藤面画面蒟82‐ ~ PECmHTYCHEMК I銭r盤 了 繭 ¨ 1榔悧I… …… 顕∴瓦 「 ~ ICase No.:457/4/82- IALC4/2017 Party Name:MALWA 10XYGEN&INDUSTRIAL IGASES PVT.LTD。 , RL扇誦g :56/24/040/00007/AM18/ 圏 蔓面薄薦雇万 ~ :Status: Deferred. 330M:鞭蔦」 'Declslon:]Deferred. 132f霊〕 賊 8湘2- 53 : IDecision :The Cornrnlttee decided to ratify norrns based on the recornrnendation ofi 1輝L蠍棚解囃里 li£捕柵鮮i牌驀件1 1 1para4.07 of HBP Vol.1. RA concerned rnal , || ParりName:PAYAL IPOLYPLAST PRIVATE 諄‖纂 ILIMITED IRLA File |:05/24/040/00042/AM18/ :|五|しヽamc:AIMSIMPEX IMCetNo/Date:7/82¨ Status:Deferred. : lrvt. Lto., IALC4/2017
F
I
22H2∝7
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iCase No.:304/4/82-
‐ALC4/2017
333 HQ File
:O1/82/050/00312/AM18/
|
:RLA File
l:03/94/040/00162/AM18/ 孵Fぼ
~‐
T編面
閉齋雷面13433瞬蕊::話
Decision: Deferred.
ase No。:391/4/82‐
ALC4/2017
踊席
OЮれ基鳥
j¨ 滉鸞よ面面hケ識濡
1ち詰
ICase No.:406/4/82‐
Paty Name:FRESENIUS
iKAB1 0NCOLOGY
.LIMITED
ALC4/2017
―
一 "6聞1輛蕊1ふ戸 ~羅 ち鵬 OЮ蔦蕊戸囲肝繭面臨i蔦 ~ ParりNamelMAHIMA LIFE SCIENCES PVT.LTD. "7鵬星児 5υ∞ %″Amν 所競蕊面蔦 ~1冥辮α“Ю“ %18鳶ち 7■2型7
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l:01/82/050/00361/AM18/
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54
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7授~
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ll:s i
lzz.lzon
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| |
・
―
―
一一
!
靭 藤cision恥滉藻 「
Dlo Pharmaceuticals forwarded vide O.M. No.35011/82512OL5-P|(Norms) dated
01.06.2016 , uploaded at the end of these minutes or as applied by the firm whichever is
less under para 4.07 of HBP Vol.L. RA concerned may take necessary action as per
decision of NC.
に
I
A
I
F
L
F
I
ase No。:302/4/82‐
LC4/2017
IHQ File
, :01 18210501003 I 0/AM I 8/
邪瓢瓢:蔦
|
1鷺λ
ttioЮ l120ハM17
22.11.2017
Decision: Deferred.
F
L
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icasご稀:303/4/8】
IALC4/2017
|
IPatt Name:AMINES&
IPLASTICIZERS LIMITED
IStatus:
翻児蕊I=扁
NLA FG
l:$l9afia0l00145/AMl8/
Paty Name:GOPINATH
ICHEM―TECH LTD.,
一
4
4
1警鮮
9/4/82‐
IPattNamettRION
ICHEMICALS PRIVATE
ILINIIITED
Status:Deferred. ,
l
l
2
7
e
t
N
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a
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2
2
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Lic.No/Dtte:0810140332 Detr i
2305.2017 1Date:27.12.20171
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54/4/"■LC例
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122.11.2017
tr.2ot7
I
I
| | IZら
Zら°
・・
.ZらVi′ t
:RLA File
ILic.No/Date:5210042277 :Defer Date:|
:23.05.2017
lDecision : The Committee decided to ratify norms based on the recommendation
,HQ File
101/82/050/00362/AM18/
124.05.2017
IMect No/Date:7/82-
IALC4/2017
lstatus:Deferred.
IRLA File
l:08/24/040/00045/AM18/
22.11.2017 1
面雨あ轟:0810140344 1Defer
124.05.2017
: Deferred.
|
Paty Name:STRIDES
ISHASUN LIMITED
rMeetNo/Date:7182' ]Status:Deferred.l
''ALC4l20l7
;
tzz.tt.zon
:
IRLA File
\:Oa Da fi40 I 00036/AM I 8/
Lic.No/Date:0410163149 1Defer
|:01/82/050/00299/AM18/
55
125.052017
IDate:27.12.2017 1
蘊濡鯖:
¨
一
一
一
`
:03/94/040/00132/AM18/
IDこ孫お1:Deおrea
,status:Deferred.
穣温
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1 :LIMITED 22.112017 1
臨腺鵬ふ論鶴,1出品並壺樫空翌整嘉二ふ
|
一
―
一
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=
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戸面面酔二i置
partv Name:VIVID
Meet No/Date:7182- istatus:Deferred.
,Case No.:435/.1/82
,^_ :_
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「
オ漏
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需
:AL NDUttRIES閉
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t需1濾溜:WttTE澄き棚ッα
782
i22.11.2017
IRLA File
r iDecision : Deferred.
|
56
,Decision : Deferred.
一
一
8
一
一
4
一
一
2
一
一
一
4
一
8
2
一
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〇
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7
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IHQ File
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|:01/82/050/00404/AM18/
:RLA File
:05/24/040/00082/AM18/
~Case No万
7/4/8r
lALC4/2017
3561南01ii3
:01/82/050/00435/AM18/
ParりName:YASHO
INDUSTRIES PVT.LTD.
:03/95/040/00169/AM18/
|:li:1):lil'百
ルル
bttI~~~~~~― 一―
|
ParりName:YASHO
INDUSTRIES PVT.LTD.
,Hq eili
RLA File
l:01/82/050/004461AM181;031951040100180/AM18/
,Paty Name:GLOBE
|
ITROTTERSPVTLTD
|
'Meet No/Date:7/82-
IALC4/2017
122.11.2017
| ICase No。:508/4/82‐ALC4/2017
13581
57
't
-----
--:
iStatus:
I
Approved
t,
a
^
1 壌霊枷″
y″秘
IPattName:USV PRIVATE IMcetNo/Dtte:7/82‐
LIMITED(FORMERLY :ALC4/2017
IUSV LIMITED)
122.n.2017
IRLA File
l:03/95/040/00147/AM18/
lstatus:Deferred.
I
pO.05.2017
IDate:27.12.2017
I lDecision : Deferred.
ICase No.:413/4/82‐
IALC4/2017
1 涯霊腸∫∬
7/4β 2‐
: |
lParty Name:JODAS EXPOIM iMeet No/Date:7182-
Status:Deferred.|
IPVT.LTD。
,
:ALC4/2017
,22.11.2017
1354FHQFi15
IRLA File
Lic.No/Date:0510402977 1Defer
1 ‐Decision:Deferred.
' ICase No.:396/4/82¨
Name:MOREPEN
LABORATORIES LTD。,
1
iMeet No/Date:1 182-
'Status:Deferred.
i
|
:Lic.No/Date:0310813691 1Defer
郷駐
31剛2∝81
,1.05.2017
^
IHQ Flle
i:01/82/050/00516/AM18/
IRLA File
103/94/040/00124/AM18/
Dlo Pharmaceuticals forwarded vide O.M. No.35011/88/2013-Pl(Norms) dated
01.04.20L3 , uploaded at the end of these minutes or as applied by the firm whichever is
less under para 4.O7 of HBP Vol.1. RA concerned may take necessary action as per
decision of NC.
Date:10.01.2018
## Case No.:401/4/82‐
:01/82/050/00409/AM18/
ICase No.:402/4/82‐
IALC4/2017
Party Name:PCL OIL&
SOLVENTS LTD.
卜lect No/Date:7/82‐
ALC4/2017
122.11.2017
HQ File
:01/82/050/00410/AM18/
:RLA File
10/AM18/ 1:05/24/040/00097ノAM18/
Lic.No/Date:0510403001
01.06.2017
Date:10.01.2018
Party Name:UNIMAX
CHEMICALS PVT LTD.
,Status:
iApproved
ALC4/2017
:22.11.2017
Case No。:488ノ4/82‐
ALC4ノ2017
ICase No。:534/4/82-
IALC4/2017
1
汗
獅
HQ File
:01/82/050/00542/AM18/
:記ざ器認WttD.
:
RLA File
:03/94/040/00171/AM18/
iSOLVENTS LTD.
IRLA File
105/24/040/00098/AM18/
No/Date:7/82¨
:Status:〕Deferred.
I
|
lDate:10.01.2018
,
: Deferred.
1器3掲5υ0044νAMlν
No/Date:7/82¨
お
Fど鼎α“Ю制
3730
: The Committee decided to ratify norms based on the recommendation
Pharmaceuticals forwarded vide OoMo No。35011/315/2014-Pi(Norms)dated
, uploaded at the end of these minutes or as applied by the firm whichever is
: Deferred.
Patt Name:V.D.H.
10RGANICS PVT.LTD
File
|:05/24/040/0019?/AMllィ
一
:
|
l~い
い
肇
画
面
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i:orlaZos0/00s41/AMl8/ l,:03194fia0/00002/AMl8/
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而
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7/82‐
LIMITED
tALC4l20l7
izz.tt.zon
| ICase No.:434/4/82‐
IAI r′
7●n■,
IALC4/2017
|
IHQ File
101/82/050/00442/AM18/
ILIMITED 122.H.2017 :
IRLA File lLic.No/Date:03108138431
1:03/95/040/00166/AM18/ 107.06.2017 :
~口
翻濡高蔦話
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漱T画面面
1 理纂獅F藤~町
The Committee decided to ratify norms based on the recommendation of D/o
|
| IPharmaceuticalsforvvarded vide O.M.No.35011/864/2015-PI(Norms)dated 10.04.2017:
i3661as under:
|
|
| |
Export ltem
lmport ltem
Norms Recommended for
1kg Artemether
Artemether-an anti-
malarial drug
Artemisinin
1.235
Sodium Borohydride
0.188
Trimethv1 0rtho Acetate
0.50
A concerned
take
action as per decision of NC.
may
necessary
pe
IP額″NameiSTERMONE
iCHEMICALS PVT LTD
IMcet No/Date:7/82-
IALC4/2017
122.11.2017
,Status:
,Approved
7
IHQ File
i:01/82/050/00374/AM18/
甲奮
IRLA File
|:34/24/040/00283/AM17/
Dlo Pharmaceuticals forwarded vide O.M. No.35011/863/20L5-Pl(Norms) dated
18.05.2016, uploaded at the end of these minutes or as applied by the firm whichever is
tless under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per
decision of NC.
3681Case No。:461/4/82¨
59
^
iParty Name:TIDE
lMeet No/Date7182-
rstatus:Deferred. I
| IALC4/2017
lNDUSTRIES
1跳ち刷:OЮ0064ハMlν
剛
:蔦I菖I誌
「
W漑戸而13824臨
:「
## Case No.:439/4/82-
ALC4/2017
IP額りName:ZYTEX
IB10TECH PVT.LTD.
~Ψ
耐
3701責O Filc ~~~
‐ ‐
~~
:01/82/050/00447/AM18/
1鷺λ酬,0/00188/AM18/
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壼
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Wivteet
NrD"t"J/8l -Ft"tr"
i
isHAsLrN LIMITED
IALC4/20I7
iApproved
I
r
lzz.rt.zort
I
Mn el"
-ilt"N./D"t"o4t0t63rtt
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Decision : : The Committee decided to ratify norms based on the recommendation of
D/o PharmaceuJca:sfomarded O.M.No.35011/155/2016-P!(Norm→
dated sept.2016′
|
luploaded at the end of these minutes or as applied bythe firm whichever is less underi
,para 4.07 of HBP Vol.1.. RA concerned may take necessary action as per decision of NC.
l
60
⌒
| |
「霊淵″
3〃
"‐
Par"Name:USV PRIVATE
ILIMITED(FORMERLY
USV LIMITED)
2
8
7
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2
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Status: Deferred.
I
1器3泥5υ0044 ν
AMl群
iCase No。:464/4/82‐
IALC4/2017
^
F
L
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ー
HQ File
ALC4/2017
.2211.2017
RLA File
:04/24/040/00051/AM18/
面5面画面百Ъ
fettedi
臨
## Case No.:437/4/82‐
響辮淵き
僻
B
剛
蕊LAMlν
1ヽ′0△●や、IA
Meet No/】Date:7/82-
嫉需
Defer
Date:21.12.2017
F「・
諄
i認T'/82‐
~
Ю 語渕画面
Lic.No/Date:0910065148
09.06.2017
ICase No.:535/4/82‐
lALC4/2017
:"8瓢iょ恵蔦葛
Paty Name:FINE ORGANIC'Meet No/Datei7/82‐
lNDUSTRIES PVT.LTD :ALC4/2017
12211.2017
間瓢蕊薦1戸
開濡1薦
,Decision: Deferred.
IMcet No/Date:7/82¨
IALC4/2017
122.11.2017
WTT
ILIFESCIENCE LTD
Party Namc:SUPRIYA
IMeet No/Date:7/82‐
lALC4/2017
22.11.2017
1Lici`86品:o315面3うib
112.06.2017
:RLA File
li03/95/040/00187/AM18/
10.01.2018
| ICase No.:300/4/82- IParty Name:GLOBAL
I IALC4/2017 iCALCIUM PRIVATE
i I
ILIMITED'
llze;s[nre
-|RL-A
File
I
l:01/82/0s0/00308/AMl8/ 1:07/241040100076/AMl8/
lli
iOecision: Deferred.
一
〇
一
8
一
‐
i
3
,
‐
‐
61
lDate:21 .12.2017
IParりName:YASHO
INDUSTRIES PVT.LTD.
IMcet No/Date:7/82- lStatus:Deferred.|
,ALC4/2017 1 1
22.11.2017 1 1
ltt ctzon
|
lStatus:Deferred.
Status: Deferred.
ICase No.:301/4/82-ALC4/2017 ParりName:U SQUARE
ILIFESCIENCE PRIVATE
LIMITED
"9要"___~1牲
全甲9___
:01/82/050/00309/AM18/ :08/24/040/00048/AM18/
IDecision:丁he Committee decided to ratlfy norms based on the recommendation of
D/o Pharmaceuticals forwarded O.Mo No.35011/151/2016-PI(Norms)dated August
2OL6 , uploaded at the end of these minutes or as applied by the firm whichever is less
under para 4.O7 of HBP Vol.1. RA concerned may take necessary action as per decision
l~~~
:誅剛ぶTttD.
1盟漱需而
「
~胃面高面
|
22.11.2017 1
M41004習蔦;IL話
lltz prQ rle
l:0 I I 821 050 I 0047 0 I AN4l 8 I
}RLA File
1,:3 4 I 24 / 040 I 00062/AM I 8/
|
rDecision : The Committee decided to ratify norms based on the recommendation of
'O7o efr.rraceuticals forwarded O.M. No.35O7Ll7O4/2015-Pl(Norms) dated 29.04.2076
t, uploaded at the end of these minutes or as applied by the firm whichever is less under
,Rara 4.OZ of HBP Vol.1. RA concerned may take necessary action as per decision of NC. I
F
I
I
諄鮒纂
:Lic.No/Date:0810140484
112.06.2017
|lf壼型2盟121型
RLA File
l:03/94/040/00204/AM18/
1 ■ё:ききヽ6.:436/4'82‐ALё4/2017 1ParりNamc:PCL OIL& lMeet No/Date:7/82-
SOLVENTS LTD.
IALC4/2017
122.11.2017
IⅧ辮α“Ю“
3104
lil11:ill:llllli:iil~~~~~―
|
Defer Date:|
110.01.2018 1
IRLA File
62
Decision : Deferred
No.:466/4/82‐
ParりNameiCAMPHOR&
ALLIED PRODUCTS
LIMITED,
Meet No/Date:7/82-
7
ALC4/2017
2211.2017
F
L
F
I
IHQ File
101/82/050/00474/AM18/
Defer
Date: 10.01.2018
Lic.No/Date:0310813982
Case No。:525/4/82‐
ALC4/2017
Party Name:CIPLA
Mcet No/Date:7/82-
ALC4/2017
22.11.2017
RLA File
:03/94/040/00211/AM18/
Lic.No/Date:0310813980 1Defer
14.06.2017 1Date:27.12.2017
:01/82/050/00533/AM18/
Party Name:NECTAR
LIFESCIENCES LIMITED
Defer Date:
Decision:丁he Commtttee decided to ratify norms based on the recommendatlon of
D/o Pharmaceuticals forwarded O.M.No.35011/198/2014-PI(Norms)dated Oct.2014′
uploaded at the end of these rninutes or as apphed by the firm whicheveris less under
## para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decislon of NC.
No。:455/4/82-ALC4/2017
:01/82/050/00436/AM18/
IRLA File lLic.No/Date:2210015725
122/24/040/00017/AM18/ 14.06.2017
Meet No/Date:7/82-
ALC4/2017
Mcet No/Date:7/82‐
ALC4/2017
122.11.2017
Status:
Approved
F
L
ド
ー
ParりName:OM
INTERCONTINENTAL
RLA File
:03/95/040/00149/AM18/
Defer
Date:10.01.2018
22.11.2017
:01/82/050/00463/AM18/
## Case No.:428/4/82‐
Lic.No/Date:0310813971
14.06.2017
Case No。:420/4/82‐
Party Name:RELIANCE
INDUSTRIES LTD.
ALC4/2017
22.11.2017
:01/82/050/00428/AM18/
:03/95/040/00106/AM18/
Lic.No/Date:0310813970 1Defer
14.06.2017
Date:10.01.2018
:Deferred.
F
L
F
I
No。:521/4/82‐
Name:J.B.
LC4/2017
112017
LC4/2017
ALS&
63
Status: Deferred.
,RLA File
14.06.2017
p88両File~
」
IHQ Flle
|
1389
HQ File
,Decision: Deferred.
RLA File
⌒
1器3児5υ0052シAMlν
IRLA File
:03/94/040/00219/AM18/
躍辮α“Ю田“り
B鳶ち
7■2期7:
F
L
F
I
閣♂ぼ~|
HQ File
臨鼎戸面孤開瓦罵
rDecision: Deferred.
ParりName:CADILA
IHEALTHCARE LTD
RLA File
:08/24/040/00069/AM18/
1鼈:濡置フ
82-
12211.2017
Defer
Date:27.12.2017
顔
77/82‐
~~「石面蘭面高
F
慾
ヽ
茄bttII漏k「
iCase No.:524/4/82‐
:ALC4/2017
P;.ty N;.,GoD[ij
IINDUSTRIES LTD。
,
IRLA File
103/94/040/00222/AM18/
FMcetNo/Date雨
IALC4/2017
122.11.2017
ILic.No/Date:0310814086
11906.2017
:01/82/050/00532/AM18/
|
l iCase No.:522/4/82‐
| IALC4/2017
397韓
O Filも
卜
01/82/050/00530/AM18/
ase No.:422/4/82-
LC4/2017
PHARMACEUTICALS
LIMlTED
陣。
iお 1鶴ち刷iOЮ0057/AMlν
l:01/82/050/00430/AM18/
圏司爾面
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|
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:22.11.2017
RLA File
116.06.2017
Partv Name:CHIRAG
IRLA File
:24/24/040/00009/AM18/
iParty Name:KEVA
FRAGRANCES PRIVATE IALC4/2017
ILIMITED
122.112017
'Meet No/Date:7/82-
lStatus:Deferred. I
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No/DttcЮ 310814083 1Detr
119.06.2017
IDate:27.12.2017
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: ICase No。:486/4/82¨ALC4/2017 ParりName:NAARIPHARMA IMeetNo/Date:7/82- Status:
l I PRIVATE LIMITED :ALC4/2017 :Approved
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l, uploaded at the end of these minutes or as applied by the firm whichever is less under
## para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.
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122.11.2017
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INDUSTRIES LTD. :ALC4/2017 1 :
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1 1AI
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Paty Name:CADILA
IHEALTHCARE LTD
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108/24/040/00080/AM18/
1
性き淵να
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IHQ File
l:01/82/050/00515/AM18/
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l:03/94/040/00230/AM18/
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65
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121.06.2017
IDate:27.12.20
rDecision : Deferred.
ICase No.:451/4/82‐ ALC4/2017 1PartyName:PCL OIL&
ISOLVENTS LTD.
406:責0ぉile RLA File
:01/82/050/00459/AM18/ :05/24/040/00134/AM18/
IMcet No/Date:7/82-
.ALC4/2017
122.11.2017
Status:
,Deferred
Lic.No/Date:05 10403 184 Defer Date:
21.06.20t7
lto.or.zors i
407 10 File
l:01/82/050/00511/AM18/
1 1Decision:Deferred.
IRLA File
:34/24/040/00075/AM18/
ICase No.:503/4/82-
ALC4/2017
IPaty NamelTIDE
IINDUSTRIES
IALC4/2017
122.11.2017
:21062017
lDate: 10.01 .201 8
I Case No。:504/4/82-
ALC4/2017
10810iぉ~~
:01/82/050/00512/AM18/
Pa■y Name:TIDE
lNDUSTRIES
IRLA File
134/24/040/00076/AM18/
Meet No/Date:7/82‐
IALC4/2017
.22.11.2017
Status: Deferred.
Lic.No/Date:3410043298 1Defer
121.06 2017 1Date:10.01.2018
| ID/ol::][Tll,VtiCalSifolwarded O.M.No.35011/233/2016-PI(Norms)dated 03.07.2013
r, uploaded at the end of these minutes or as applied by the firm whichever is less under
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ICase No.:495/4/82‐
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Ptt NamaCA〕LA Me∝
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‐ ICase No.:494/4/82‐ ALC4/2017 ParりName:CADILA Meet No/Date:7/82- status:
| I HEALTHCARE LTD ALC472017 1Approved
122.11.2017 1
: IHQ File RLA File Lic No/Date:0810140544 1Defer Date:
4091:91(11/9,9/09,07管M18/ 191/74(919/99979/AM18/ 122.06.2017 1
1 1Decision:丁he Committee dec:ded to ratify norms based on the recommendatiOn of
―
一
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‐Case No.:528/4/82-
'Party Name:J.8.
l
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66
122.11.2017
|
Status: Deferred.
i
ILic No/Date:3410043299 1Defer
1
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ALC4/20 17
CHEMICALS&
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1器3児50Ю 053αAMlν
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Status:Deferred.
IMcet No/Date:7/82‐
IAI ρ4/つ017
IALC4/2017
122.11.2017
而臨1扁
F面高面
iCase No.:558/4/82-
lALC4/2017
Pa,y NamelTITAN
ILABORATORIES PVT.
:LTD.
IRLA Fne
|:03/95/040/00260/AM18/ 圏謡爾面
/82-
1 0814205
Status:Deferred.
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IDate:27.12.2017
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IHQFilざ~~~‐
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:01/82/050/00566/AM18/
ICase No.:561/4/82¨ ParりNamc:YASHO
iALC4/2017 .INDUSTRIES PVT.LTD.
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|:01/82/050/00569/AM18/ :03/95/040/00266/AM18/
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|
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IGENERICS LTD
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IMcet No/Date:7/82-
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22.11.2017
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[3
ICase No.:559/4/82‐
IALC4/2017
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HQ File
t
t:011821050/00567/AMl8/
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i
|
IMeet No/Datc:7/82‐
lALC4/2017
122.11.2017
Status: Deferred.
Lic No/Date:0310814211 1Defer
IHQ File
IRLA File
Lた。No/Dtte:0310814244 1DetrDtte:|
23.06.2017 1 1
騰Ⅷ点期榔嚇:r::『tW《職。
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1踏鮮器淵卜披空窒型型L型
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,
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,'D/oPharmaceuticals forwarded O.M. No.35011/1g6/20L4-Pl(Norms) dated Oct.ZOL4,
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69
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7.12.20171
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ParりName:MAMTA
IPOLYCOATS
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IALC4/2017
122.11.2017
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| ,Case No.:548/4/82¨
: IALC4/2017
IPa中
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iMeet No/Date:7182-
:ALC4t20t7
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,status: Deferred. '
一
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L
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ICase No。:481/4/82-
IALC4/2017
,
IHQ File
101/82/050/00489/AM18/
IParサName:DALAS
IBIOTECH LTD.
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105/23/040/00040/AM18/
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|
Palty Name:WANBURY IMeet No/Date:7/82- status:Deferred.|
4361Case No.:516/4/82-
:WANb∪KY Meet No/Date:7/82- status:Deferred.|
ヘ
:Lic.No/Date:3410043328 1Defer
|
詢5.07.2017
IDate:27122017
| ICase No.:460/4/82-
‐ IALC4/2017
ParりName:HI
INDUSTRIES
1造棚να
782‐
122.11.2017
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|
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IHQ Flle
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105.07.2017
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7.12.20171
| ::01/82/050/00468/AM18/
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rDecision: Deferred.
10507.2017
3鳶10.01.20181
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2
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122.112017
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l:34/24/040/00089/AM18/
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:
l i:01/82/050/00507/AM18/
、05.072017
IDate:10.01.2018 1
i
1
ParりName:SUNSHIELD IMcet No/Date:7/82‐
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111.07.2017
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70
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l:01/82/050/00524/AM18/
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, iDecision: Deferred.
Party Name:YASHO
iMeet No/Date:1/82-
l
lStatus:Deferred.
NDUSTⅢES PVT.LTD.1銭
r盤
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IRLA File
:03/95/040/00316/AM18/ 12.07.2017
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LTD
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lALC4/2017
1;
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INDUSTRIES PVT.LTD. :ALC4/2017
1 12211.2017
Status:Deferred.
|
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| ICase No.:469/4/82-
| .ALC4/2017
麗鶉‐
~~
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1硼麒蔦蔦| |
藤苫No/Datα782¨
IALC4/2017
122.11.2017
IRLA File
|:34/24/040/00080/AM18/
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ILIFE SCIENCES LIMITED
IHQ File
|:01/82/050/00514/AM18/
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|:::::i:ll::|:|lillli:i「
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101/82/050/00479/AM18/ :13/24/040/00020/AM18/
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20.07.2017 :Date:10.012018
諄甲事~F続~
72
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| ICase No.:470/4/82¨ ParりName:RONAK
I IALC4/2017 cHEMICALS
| | |
No.:540/4/82‐
1 1ALC4/2017
I
⌒
扉稿正
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i:01/82/050/00560/AM18/
一
|
IRLA File
103/95/040/00851/AM17/
## Case No.:552/4/82‐
ヨ
ALC4/2017
22.11.2017
ILic.No/Date:0310814738 1Defer
121.07.2017 ‐Date:10.01.2018
Decision: Deferred.
「~~「
ca面高1553/4/82‐
IALC4/2017
開脇薦I蔦了
師
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而
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2田艦蕊蔦」
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lCHEMICALS LIMITED
|
囮
蕊扁
ICase No.:555/4/82‐
IALC4/2017
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ICHEMICALS LIMITED
itvteetNozoatil:tte-'iirtmto;i;;;J.
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t
:22.11.2017
i
閉癬
031081而臨満I
531HQ Fil`
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IRLA File
1/82/050/00563/AM18/
IЮ3/95/040/00652/AM17/
D ecision : Deferred.
22.11.2017
1Lic No/Date:0310814753
21072017
Defer
Date:27.12.2017
ICase No.:483/4/82-
:ALC4/2017
55田既蔦高萬蔦
‐Decision:Deferred.
73
,Status:Deferred.
r
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| ICase No.:500/4/82- Paty Name:RECKITT
14561ALC4/2017 1BENCKISER
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1銭『獄了 |
RLA File
Lic.No/Date:0310814740 1Defer
|
121.07.2017
IDate:10.01.2018 1
I
,Case No.:551/4/82-
', '1X-Cllz}tl
ParりName:SPAK IMcet No/Date:7/82‐ iStatus:DeFerred.|
,SURFACTANTS PVToLTD IALC4/2017 : |
打4朧
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:Decision : Deferred.
I iHQFl.
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I l:01/82l0s0/00s08/AMl8/ l:05Da/0a0fi0148/AMl8/ lz+.ot.zon
iDate:27.12.20t7
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lDate: I 0.0 I .20 I 8
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## Case No.:556 /4182-ALC4/2017 ParryName:ZIM
Meer No/Dat e:7182- Status
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LABORATORIES LTD.
NLC4t20t7
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l
22.11.2017
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:
iD/o Pharmaceuticals forwarded O.M. No.35OLt/40412016-Pt(Norms) dated 26.09.20L7
;
,, uploaded at the end of these minutes or as applied by the firm whichever is less underl
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lpara 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. l
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14621Case No.:549/4/82‐
,ParけName: ROYAL
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74
IMeet No/Date:7/82‐
ヘ
| ‐
lё iζきヽ6::414,4,8'LALむ4/2biケ
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ALC4/2017
F話血
レγ盤了 「
01/82/050/00557/AM18/
IRLA File
l:03/95/040/00345/AM18/
|】Decision: Deferred.
貯淵
8/4/82-
|
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IPHARMA PVT.LTD.
IRLA File
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125.07.2017
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l:04/24/040/00079/AM18/
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Decision: Deferred.
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77
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IRLA File
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## Case No.B-01 1Mノs.RA Chem Pharma
M.No.07ノAM-18 1 File No.01ノ82ノ050ノ00651ノAM 15
Date 22.11.2017
| ROv.Rutn. No. 0910055973 dated. 09.05.2013
Adv.Auth.No.0910057516 dated.10.09.2013
Adv.Auth.No.0910059417 dated.25.02.2014
Decision: The Committee considered this case for re-fixation of norms as per agenda. The
Committee decided to send copy of representation of the firm to DoP for their comments.
## Case No.B-02 1M/s KLJ Plasticizers Ltd
M.No.07ノAM-18 1 File No.01ノ82ノ050ノ00772/AM ll
Date 22.11.2017 1 RLA No.05ノ23ノ040ノ00078ノAMll
Adv.Auth.No.051 0267557 dated.06.07.2010
Decision:The Committee considered this case for correction in the description of import item from
Ephathalic Anhydride to Phthalic Anhydride as per agenda. The Committee based on the
recommendation of DIPP No.7130912017-TSW dt. 19.07.2017, uploaded at the end of these
minutes decided to correct the description of import item. RA concerned may take further
necessary action as per decision of NC.
## Case No.B‐ 03
M.No.07ノAM… 18
Date 22.11.2017
Mノs.Mangalam Drugs&Organics Ltd
F‖e No.01ノ82ノ050ノ00743rAM 17
RLA No.03/95/040ノ00419ノAM 15
Adv.Auth.No.0310788371 dated.26.08.2014
Decision:The Committee considered this case for revision of norms as per agenda. The
Committee based on the recommendation of Department of Pharmaceuticals
O.M.No.3501118641201S-Pl(Norms) dated 10.04.2017 decided to maintain status quo. RA
concerned may take further necessary action as per the decision of NC.
## Case No.B-04
M.No.07/AM-18
Date 22.11.2017
Decision: The Committee deliberated on the request of the firm fonryarded by SEZ Pondicherry
vide their letter number$l403l2O03lSEzl341 dated 26.08.2016 for fixation of Norms for the export
product "Cholic Acid from imported Bile Paste" to close the job work file. The Committee decided
to alloMratify the norms in respect of the above mentioned export product based on the earlier
decision of Norms Committee taken in its meeting No.01/AM15 dated 21.04.2014 case No.B-
3(Part-l!) uploaded at the end of these minutes.
RA concerned may take further
action as per the decision of NC.
M/s,Pharmazel(lndia)PVt Ltd
File No.01ノ82ノ162/117/AM 18
************
78
F. No.3501 1/221l20{ 6-Pl (Norms)
Government of lndia
Ministry of Chemical & Fertilizers
Department of Pharmaceuticals
Room No.310, B-Wing,
Janpath Bhawan, New Delhi,
Dated: September 26, 2017
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-20
Case of M/s Optimus Drugs Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O.No. 0118215012321AM-18/DES-
3/141 dated the 1410612017 vide which application from M/s Optimus Drugs Pvt. Ltd.
was sent to this Department for fixation of norms under para: 4.7 tor the export of
Daclatasvir Dihydrochloride. This department has examined the matter and DGFT is
advised to call following details from the firm viz:-
1) The import item no.'1 i.e.4,4-bis (chloromethyl) biphenyl does not match with the
process detail /chemistry furnished by the firm.
2) Revised process or description of import item may be given.
3) Past production vis-i-vis actual consumption of all imported imported inputs duly
certified by Central Excise Authorities may be given.
4) % age of yield at each step of reaction on molar basis with chemical formula &
M.W. of each chemical involved in reaction.
(PaⅣeen Kumar)
Under Secretary to the Government oflndia
E―mJ!:parveen 19@goV m
Ph:-23352298
Directorate General of Foreign Trade,
Department of Commerce,
(Shn S K Panigrahり
,
∪dyOg Bhawan,New Delhi
E‐ mail:sk panttrahi@nにin
Phi 23061562,Extn 269
F.No.35011ノ227′2017‐ (P卜Norms)
Government ofindia
no 31
, B-wing, 3'd floor,
Janpath
,New Delhi,
Dated November ,2017
## Subject: - Fixation of norms under para
of Hand Book
Procedures (Vol.l) 201 5-
20 case of M/s Hetero La
The undersigned is di
to referto DGFT
01/82ノ050ノ01305/AM―
17ノDES-3/1127 dated the 21
17 vide which
Ltd. was sent to this
for fixation of
of 3‐ [3‐(4¨Fluoropheny:)‐ 1
1‐Methylethyり‐
1
ndol‐ 2‐YL]‐ (E)‐ 2‐Propenal. This
department has exam
the matter and
is requested to call following
information from the
ヽ¨黙¨L::∬嘉違
of low yield clai
ine.6,.-A i\s S
型に
Of
3
literature in support
2)
This issues
the approval of
petent authority.
ry to the
Kumar)
of lndia
Directorate General of Foreign T
Shn S K Pan19rahi,Economic
Phone No:23061562,(269),
∪dyog Bhawan,New Delh卜110011
Email:sk panbrahiOnに
in
ication from M/s Hetero Labs
under para: 4.7 for the export
by firm
yield claimed by lr,
Emal:
F. No.350 1 1 I 196t201 7-(pt-Norms)
Government of lndia
Ministry of Chemicals & Fertilizers
Department of pharmaceuticals
Room no.310, B-wing, 3d floor,
Dated: November ,2011
Office Memorandum
## Subject: - Fixation_of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2O1S-20
case of M/s Mylan Laboratories Ltd.
The undersigned is directed to refer to DGFT U.O. No. Oltgzl}So/o1307/AM-
17IDES-3/1 136 dated the 211312017 vide which application from M/s Mylan Laboratories
Ltd. was sent to this Department for fixation of norms under para: 4.T for the export of
Dipyridamole. This department has examined the matter and the following norms are
furnished under para 4.7 of Hand Book of procedures (Vol.l) 201s-20:-
S
.
N
。
lmport item
Norms recommended
for 1kg export
1
2,6-Dichloro-4, 8-Dipiperidino-Pyrimido-(4, 5-d)
Pyrimidine
0.935k9
2
Diethanolamine
0.669kq
3
Toluene
3.2kq
This issues with the approval of competent authority.
(Parveen Kumar)
Under Secretary to the Government of lndia
Phone:23352298
Email: parveen. 1 9@qov.in
Shri S.K. Panigrahi, Economic Officer, DES-Ill
Phone No: 2306'1562, (269),
Udyog Bhawan, New Delhi
Email: sk.paniqrahi@nic.in
2.)
F. No.350 1 1 11051201 7-(Pl-Norms)
Government of lndia
Room no.310, B-wing,
Dated: October 23,2017
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-20
case of M/s Suven Life Sciences Ltd.
The undersigned is directed to refer to DGFT U.O. No. 01182105010102914M-
17IDES-3/946 dated the 101212017 vide which application from M/s Suven Life Sciences
Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of
Benzhydryl Thioacetamide. This department has examined the matter and the
following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2015-
20:-
(Parveen Kumar)
Phone:23352298
Email: Parveen. 1 9@gov.in
2.)
Shri S.K. Panigrahi, Economic Officer,
Phone No: 23061562, (269)'
Email: sk. paniqrahi@nic. in
DES― l‖
S. No.
lmport item
Norms recommended for
1ko export
Hvdro Bromic Acid
1.052kq
2
Thio Urea
0.421kg
3
Benzhvdrol
0.842ks
4
2-chloroacetamide
0.456ks
ヘ
F. No.350l1185120fi -pI (Norms)
Govemment of India
Udyog Bhawan,
New Delhi, the 8th December, 2011
Office Memorandum
Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2OOg- 14 Case of IWs
SUVEN LIFE SCIENCES LTD.
The undersigned is directed to refer to DGFT u.o.No. 0ll82l5Ol0l7l6lAMl1/DES-3/103
dated the 02l05lll vide which an application from M/s SUVEN LIFE SCIENCES LTD was sent
to this Department for fixation of norms under para:4.7 for the export of FPENICILLAMINE.
This department has examined the matter and the following comments are fumished under para
4.7 of Hand Book of Procedures (Vol.l) 2009-14:-
S. No.
lmport ltem
Qty. Recommended ke/kg.
1. ISO BUTYRALDEHYDE
4.532
2. 30DIUM CYANIDE
1.29
3. PHYNYL HYDRAZINE
2.20
4. D―TARTARIC ACID
1.828
This issues with the approval of Deputy Director General.
(V.K.Tyagi)
Dupty Industrieal Adviser
Depaftment of Commerce,
(Shri Shyam Lal, FTDO), Udyog Bhawan, New Delhi.
v
a3f
F. No.350 1 1 17 37 1201 7-(Pl-Norms)
Government of lndia
.
Room no.310, B-wing, 3'd floor,
Dated: November ,2017
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vot.l) 2015-
20 Case of M/s Orch Laboratories lndia Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O. No. 011821050/00326/AM-
18/DES-3/171 OateO the 21tgl2o17 vide which application from M/s Orch
Laboratories lndia Pvt. Ltd. was sent to this Department for fixation of norms under
para: 4.7 for the export of L-Methyl Glyoxylate Hydrate (MGH). This department
has examined the matter and the iollowing norms are furnished under para 4.7 of
Hand Book of Procedures (Vol.l) 2015-20:-
2.) This issues with the approval of competent authority'
(Parveen Kumar)
Phone:23352298
Email: parveen. 1 9@gov. in
Directorate General of Foreign Trade'
Sh;i S.K. Panigrahi, Economic Officer, DES-Ill
Phone No: 23061562, (269),
Udyog Bhawan, New Delhi-1 1001 1
Email: sk. Paniqrahi@nic.in
S. No.
lmport item
Norms Recommended
for 1kq Export
1
Glvoxvlic acid 50%
0.752ks
2
L (-) menthol (FreshfRecovery)
0.80kg
3
Cyclohexane
1 41kg
\\\
Shastri Bhawan, New Delh
Dated: April 10,2016
F. No.3501 1/864/2015-Pl (Norms)
Government of lndia
Ministry of Chemical & Fedilizers
Office Memorandum
Sub: - Fixation of norms under para 4.7- Application of M/s l\rangalam Drugs & Organics Ltd., Vapif(
export of Artemethor-an anti-malarial drug.
The undersigned is directed to refer to DGFT U.O. No. O1/82/50/01646/AM16/OES 3ti762 date
02.03.2016 and subsequent letter from M/s Mangalam Drugs & Organics Ltd, for fixation of norr
against export ol Artemether-an anti-malarial drug. lt may be recalled that foltowing norms wer
earlier recommended against some of thes€ applications.
have requested to increase it to 1.75 kg/kg as against 0.50 kg allowed against 1 kg of Artemether.
3) Technical examination: (i) The manufacture of Artemether (M.W 298) from Artemisinin (M.W 28i
is essentially a two slage process. ln the first stage Artemisinin is reduced to get Dihydro Artemisini
(M.W 284). 90.3% ylold is claimed by the applicaot in this stage. During second stage TMOA is use
to convert Dihydro Artemisinin into Artemether crude with 84.4 7o reported yield. Ihe crude en
product is subjected to purification and 91.4 o/o yield is reported by lhe applicant. Considerang th
percentage yields obtained at each stage by the company only 0.52 kg TMOA is the calculate
requiremenl for 1 kg Anemether. Furthermore, in all other applications from other companies n(
more lhan 0.50 kg TMOA has been allowed.
4) The norms allowed for the export product were also based upon roughly same levels of yield
obtained in manufacture of Artemisnin. The DoP has considered 90% optimum yield in first stag(
85% yield in second stage and 95% yield in the purilication stage.
5) ln view of the above, there is no justification for upward revision of TMOA consumption norm
allowed against this application
6) Thrs rssues with the approval ot competent authority
(Barnali Khastgi
Under Secretary to the Government of lndi
Phone: 23323292lEmail barn khast(Anic.i
(Shri Nirmal Kumar, Dy DGFT),
tjdyog Bhawan, New Delhi
Email: nirmal.kuma165@nic-in
(
/
F. No.350 1 1 12361201 7-(Pl-Norms)
Government of lndia
Room no.310, B-wing, 3'd floor,
Dated: November ,2017
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-20 case of M/s
Unimax Laboratories Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O. No. 011821050/00103/AM-17lDES-3t167
dated the 211912017 vide which application from M/s Unimax Laboratories Pvt. Ltd. was sent to this
Department for fixation of norms under para: 4.7 for the export of Clobetasol 17
Propionate/Clobetasol Propionate. This department has examined the matter and the following
norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2A$-20-
S. No.
lmport item
Norms recommended
for 1ko export
1
Betamethasone
1 00kq
2.)
(Parveen Kumar)
Phone:23352298
Email: parveen. 1 9@qov. in
Shri S.K. Panigrahi, Economic Officer, DES-Ill
Udyog Bhawan, New Delhi-1 100'1 1
Email: sk.paniqrahi@nic. in
F. No.350 I I I 151 12012-PI Qllorms)
Government of India
Udyog Bhawan,
New Delhi, the
July,20l2.
Office Memorandum
Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case of M/s IPCA
Labs Ltd.
The undersigned is directed to refer to DGFT U.o.No. 0t18215011101/AMl2lDES-3lr71l dated the
24l0lll2 vide which an application from M/s IPCA Labs Ltd was sent to this Department for fixation of norms
under para: 4.7 for the export of Paroxetine Hcl Hemihydrate. This department has examined the matter and the
following comments are furnished under para4.7 of Hand Book of Procedures (Vol.l) 2009-14:-
多
ぉ
ハ
S. No.
lmport ltem
Qty. Recommended ke/ke.
1
(-) Trans-4R-(4-Fluorophenyl)-3S-Hydroxymethyl-N-
Methyl Piperidine
0.9511
2 Sesamol
0.55
3 Dimethyl Sulfoxide
2.9293
2.
This issues with the approval of Economic Advisor.
(Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi.
Qrl.N.Ahuja)
Section Officer
PI-Norms
F. No.350 1 1 I 41 41201 6-(Pl-Norms)
Government of lndia
Room no.310, B-wing, 3td floor,
Dated: November ,2017
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-20
case of M/s Cadila Healthcare Ltd.
The undersigned is directed to refer to DGFT U.O. No. 011821050/00041/AM-
18/DES-31243 dated the 251912017 vide which application from M/s Cadila Healthcare
Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of
Memantine Hcl Tablet 1Omg & 20m9. This department has examined the matter and
the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l)
2015-20:-
S.
No.
lmport item
Norms recommended
10mg
20mg
Memantine Hcl
10.2mg per
tablet
20.4mg per
tablet
2.) This issues with the approval of competent authority.
(Parveen Kumar)
Phone: 23352298
Email: parveen. 1 9@sov. in
Shri S.K. Panigrahi, Economic Officer, DES-Ill
Udyog Bhawan, New Delhi, Email: sk.panisrahi@nic.in
レ
「
イ
c
a
s
c
。
f
”
イ
′
・‐
4
9
0
0
2
0
剛
## Subject: - Fixation of norms under para4.7 of Hand Book of Procedures
The undersigned is directed to refer to DGFT U.O.No. 0118215013021AM-L6|DES-3/544
dated the 09107115 vide which application from M/s. Alkaloids Corporation Ltd was sent to this
Department for fixation of norms under para: 4.7 for the export of Noscapine BP/lloscapine
Hydrochloride BP. This department has examined the matter and the following norms are
furnished under para4.7 of Hand Book of Procedures (Vol.l) 2009-14:-
(Raj Kumar)
Under Secretary to the Government of India
Phone:23071162
Directorate General ofForeign Trade,
Department ofCommerce,
(Shri M.V.Singh,FTDO),
Udyog Bhawan,New Delhi
F. No.350 1 1 I 43612015-PI Qllorms)
Government of India
Udyog Bhawan,
New Delhi, the
October, 2015
Office Memorandurh
## Subject: - Fixation of norms under para4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of
The undersigned
dated the 15/07/15 vide
is directed to refer to I)(}E週墜J」¬
C圧下可る
「0-00
可6/pES-3/609
S.No.
Import Item
Qty. Recommended kg/kg.
Noscapine Crude Content 95 %
1.158
which application from M/s. Alkaloids Corporation Ltd was sent to this
ィ
´″J(〔
:::::;)ニ
ニニ
「
`
F.No.35011/36/2017¨ PI(Norms)
Government oflndia
Ministry of Chemical&Fertilizers
Department of Pharrnaceuticals
Room No. 302, 3td Floor,
Janpath Bhawan New Delhi,
Dated: October 17,2017
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14
Case of M/s Alembic Pharmaceuticals Ltd.
The undersigned is directed to refer to DGFT U.O.No. 011821050/00866iAM-
17IDES-3/793 dated the 2811212016 vide which application from M/s Alembic
Pharmaceuticals Ltd. was sent to this Department for fixation of norms under para: 4.7
for the export of Clarithromycin enteric coated granules €e4#*a* 42%. This
department has examined the matter and the following norms are furnished under para
4.7 of Hand Book of Procedures (Vol.l) 2009-14: -
2.
(Parveen Kumar)
Phone:23352298
Email: parveen. 1 9@qov. in
(Shri S.K. Panigrahi, Economic Officer, DES-Ill
Email: sk.panigrahi@nic.in
Product to be Exported
Raw materials to be imported
Description
Qry
S.No.
Description
Quantity for fOθ 0
的
eツ
C
Ies 30%
Chtth"dn
273メXンKし
2.
Acetdne
/ィ508.00 kg
Clarithromycin enteric
coated granules 42%
f000 kg
Clarithromycin
403.00 kg
2.
Acetone
1031.50 kg
F. No.350 1 1 1217 l2A1 7-(Pl-Norms)
Government of lndia
Room no.310, B-wing, 3td floor,
Dated: November ,2017
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-20
case of M/s Divi's Laboratories Ltd.
The undersigned is directed to refer to DGFT U.O. No. 0118210501012231AM-
17IDES-311144 dated the 231312017 vide which application from M/s Divi's Laboratories
Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of
Free Amine Pivalate Ester. This department has examined the matter and the
following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2015-
2o'.-
S. No.
lmport item
Norms recommended
for 1kq export
CBZ Aminonitrile
1.49kq
2
Hvdroxyl amine free base - Sao/o
0.60kg
3
Petroleum ether 90 - 100 (Heptanes)
2.30kq
4
lso propyl alcohol
3.06kg
5
Methanol
6.92Bkq
6
Methvl tertiarv butvl ether
3.08kg
7
N-methvl-2-pyrrolid inone
1.51ks
8
Glvcolic acid(70%wet)
0.533kq
9
Palladium metal
0.001lkq
1O
Methyl-iediCe
444ire
Hvdrobromic acid
0 98kq
12
Fumaric acid
1.264kg
13
Caustic potash flakes
2.4ks
2.)
(Parveen Kumar)
Phone:23352298
Email: Larveen. 1 9@sov.in
Shri S.K. Panigrahi, Economic Officer,
Udyog Bhawan, New Delhi-1 1001 1
DES― |‖
F. No.350l l/26412012-PI (Norms)
Government of India
udyog Bhawan,
New Delhi, the
July,2012.
Office Memorandum
Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case
of M/s Satya Deeptha Pharma Ltd.
The undersigned is directed to refer to DGFT U.O.No. 0ll82l50ll450lANll2lDEs-3/41
dated the 09104112 vide which an application from IWs Satya Deeptha Pharma Ltd was sent to
this Department for fixation of norms under para: 4.7 for the export of (1S,4R)-4-(2-Amino-6-
Chloro-5-Formamido-4-Pyrimidinyl) amin![Z-Cyclopentene-1-Methanot (AFC]. This
department has examined the matter and the following comments are furnished under para 4.7 of
Hand Book of Procedures (Vol.l) 2009-l4i
S. No.
Import Item
1
i+) -2 - Azabicy clo(2.2.1) Hept-Ene- 3 -One
[Vancelactam) 100%
1.832
つ
乙
N-(2-Amino-4,6-Dichloro- 5 -Pyrimidinyl)Formamide
0.764
3 Pyridine
2.872
4 Sodium Borohydride (SBH)
0.226
″
D
Methanol
6.058
6
D¨Taltaric Acid
1.06
7 Iso Propyl Alcohol
3.530
& Rriz+rhq5'lvfFrh?ne
2**
2. This issues with the approval of Econonlic Advisor.
(N.N.Ahuja)
Section Officer
PI-Norms
(Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi.
ヘ
F. No.350I II55912014-PI (Norms)
Govemment of India
Udyog Bhawan,
New Delhi, the April, 2015
Office Memorandum
Sub: Fixation of norms under paru 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of
M/s. Suven Life Sciences Ltd.
The undersigned is directed to refer to DGFT U.O.No. 011821501652lAMI5|DES-31771
dated the2lll0ll4 vide which an application from M/s. Suven Life Sciences Ltd was sent to this
Department for fixation of norms under para:4.7 for the export of DoxoffIline. This department
has examined the matter and the following comments are fumished under para4.7 of Hand Book
of Procedures (Vol.l) 2009-14:-
S. No.
Import Item
Iheophylline
0.80 kg/kg
2.
Shloroacetal Dehyde Dimethyl Acetal
0.80"
う
0
Potassium Carbonate
0.61"
4.
νlcthanol
0.63 "
5.
Dimethyl Formamide
0.40"
2.
This issues with the approval of Director (PI).
(Barnali Khastgir)
Phone- 23071162
(Shri M.V. Singh, FTDO),
F. No.350 11 13612017-Pl (Norms)
Government of lndia
Room No. 302, 3'd Floor,
Janpath Bhawan New Delhi,
Dated: October 17,2017
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14
Case of M/s Alembic Pharmaceuticals Ltd.
The undersigned is directed to refer to DGFT U.O.No. 011821050/00826/AM-
17IDES-3/801 dated the 2611212016 vide .which application from M/s Alembic
Pharmaceuticals Ltd. was sent to this Department for fixation of norms under para: 4.7
for the export of Clarithromycin enteric coated granules 30% and 42o/o. This
department has examined the matter and the following norms are furnished under para
4.7 of Hand Book of Procedures (Vol.l) 2009-14: -
2.
(Shri S.K. Panigrahi, Economic Officer,
Email: sk.paniqrahi@nic. in
(Parveen Kumar)
Phone: 23352298
Email: parveen. 1 9@qov' in
DES-III
Product to be Exported
Raw materials to be imPorted
Description
Qtv.
S. No.
Description
Quantity for 1000
kg
Clarithromycin enteric
coated granules 30%
1004 kg
Clarithromycin
273.00 kg
2.
Acetone
698.00 kg
Clarithromycin enteric
coated granules 42%
1000 kg
Clarithromycin
403.00 kg
2.
Acetone
1031.50 kg
F. No.350 1 I I 1381201 7-(Pl-Norms)
Government of lndia
Room no.310, B-wing, 3'd floor,
Dated: October 31,2017
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-20
case of M/s Amanta Healthcare Ltd.
The undersigned is directed to refer to DGFT U.O. No.01/821050/01068 &
00946/AM-17/DES-3/843 dated the 21312017 & 5111201 Tvide which application from M/s
Amanta Healthcare Ltd. was sent to this Department for fixation of norms under para:
4.7 for the export of Sodium Hyaluronate eye drops O.2Yo. This department has
examined the matter and the following norms are furnished under para 4.7 of Hand
Book of Procedures (Vol.l) 2015-20:-
2.) This issues with the approval of competent authority.
(Parveen Kumar)
Phone:23352298
Email: parveen. 1 9@gov. in
Shri S.K. Panigrahi, Economic Officer, DES-Ill
Email: sk.paniqrahi@nic.in
S. No.
lmport ltem
Norms recommended for 1000
injections
Sodium hyaluronate
20.4gms/1 000 injections
(
′
(
θ 7
ヽグレク
「~璃
湖濡F藤
~~~瞬
霊漱習霊W露″ 圏緊評
~|
/
Decision lt、vas dccidcd to dFer the case for 2_1発2013forcoFrmentsoflDepartmentofl
Pharmaceuticals.
Decision :lt was decided to
」
「
FttM“
麟
Кψ嘘
隅
鵬
躙
缶D.~翻
Fぼ
W癬
207
--
-
[Ll"N"7b"t.'J3 tol t 4240 p"f., D"t.,
l:oriszlosoror008/AMr3/ l:$t9sfia0/00444/AMt3t los.tt.zotz
I
fDecision : L th. l,ght "f *ritt.r*"rr,-.r,t; ad.i.*d fr"* D.p"tt**t "i Cfot"itf. urO
lPetrochemicals vide their OM No. 4601112212008-PC II dated 8.2.2013, it was decided to
lratify norrns under para 4.7 of HBP v 1 as per details given below or as applied by the
lfirm, whichever is less:
|
Export product
Exp.
Qtv.
SI No
lmport items
Qty. allowed
lntra Uterine
Contraceptive Device
CU 380 AG
ノ
l No
1
Copper Wire with Silver
core
0 000455 kg
2
HDPE Granules
0.000130 kg
3
Pouches(PlaStiC)
Net+10%
4
Compound of LDPE Resin
and Barium Sulphate
0.000560 kg
`5
PVC Granules
0.000736 kg
6
HDPE Granules (or Nylon
Resin) MedicalGrade
0.000059 kg
7.
Polvoroovlene Granules
0.002092 kq
lntra
Uterine
Con\raceptive Device
- Coppel T 380 A
\\
l No.
1
\
Copper Wire of high
conductivity 99.99% Pure
Coooer
0 000204 kg
2
\
HDPE Granules
0 001202 kg
3
ヽRouches(Plastic)
Net+10%
4
Ю肱
h
¨
e
‐
g
u
r
h
p
0 000169 kg
5
Polvpropylene lS<anules
0.0015543 kg
6
:踏退
l:‖ tilた累哭
n
0 000415 kg
7
PVC Granules
0 000658 kg
8
HDPE Granules (or Nylon
Resin) MedicalGrade
い毀177 kg
IRA rnay take appropriate action as pcr thc decision ofNollllS COmΠ
littee.
i iCasc No.:7/28/82‐ ALC4/2012 Party Namc:MELZER IMcet No/Date:1/82- Status:Case
[^^l~“
。シ~V¨・・――・―― ‐^一―¨――^―
「
il卦ЙatsPvT.LTD IALC4/20マ
IDeFerred
響8 1
| 1器疏5α0097″AM Ⅳ
陪允酬:0/0013″AMlν
清習lttα
3H0056上
部講L2Ю
'201,|
〉
ゝ
/
へ
、
ハ
The undersigned is directed to refer to DGFT U.O.No. 0ll82l50ll0l7l1^Ml2lDBs-
311599 dated the l2l0lll2 vide which an application from M/s Alembic Ltd was sent to this
Department for fixation of norms under para: 4.7 for the export of Azithromycin Step 3. This
department has examined the matter and the following comments are furnished under para4.7 of
Hand Book of Procedures (Vol.l) 2009-14-
Export Product--- Azithromycin Step 3
(Aza- E ryth ro myci n)-1 kg A
Sub: Fixation of norms under para4.7 of Hand Book of Procedures (Vol.l) 2009-
of M/s Alembic Ltd.
(Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi.
F. No.350 I 1 l7 512012-Pl (Norms)
Government of India
F. No.350 1 Y l0l 12012-PI (Norms)
Government of India
New
Office Memorandum
Udyog Bhawan,
Delhi, the
1u1y,2012.
14 Case
(N.N.Ahuja)
Section Officer
PI-Norms
S. No.
lmport ltem
Qty. Recommended ke/ke.
1 Erythromycin
L85 \.GE
2. Hydroxylamine HCL
0-3E .s.-t
3 Methanol
!.09 v-
4 Methylene Sulfonyl Chloride
U69 ,66
5 Acetone
L.2l U-
6 Ethyl Alcohol
.*otLr2, G / L|
子506on
-:-Oggnr
ヽЦν炒ψ 黙
eo5a1^
tt
2.
This issues with the approval of Economic Advisor.
0
}
F. No.350 1 | 18612013 -PI (Norms)
Govemment of India
Udyog Bhawan,
New Delhi, the 29th April,2013
Office Memorandum
## Subject: - Fixation of norms under paru4.7 of Hand Book of Procedures (Vol.l) 2O0g-14 Case of
The undersigned is directed to refer to DGFT U.O.No. 0ll82l5}l831/AM13/DES-3/930
dated the 15/1lll2 vide which an application from M/s. Tonent Pharmaceuticals Ltd was sent to
this Department for fixation of norms under para: 4.7 for the export of Amtodipine arrd
Valsartan Tablets. This department has examined the matter and the following comments are
furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14l.-
S,No.
Export Product
Import recommended for lNo. Tablet
1
Valsartan 40 mg Tablets
Valsa rtan------40.8 mg
2.
Valsartan 80 mg Tablets
y'alsartan--------81.6 mg
3.
Valsartan 160 mg Tablets
/alsartan-------- 1.63.2 mg
4.
Valsartan 320 mg Tablets
y'alsartan-- -----326.4 mg
´
D
\山口\5 mg+臨質
m16kgTabl∝
ヴ
Jsattan\―‐
1632 mg
6.
へ
nlloδ、氏
te lヽmgキ |ミSartan 320 rng、セ
lCt
y'alsartan_____\zo.+ ms
7.
へrnlodipine〕じヽQg+Valsartan 160 rng Taδ kく、、
y'alsartan-------- t\
mS
8.
Amlodipine 10 mg NQlsartan 320 mg Tablet
ia I sa rta n--------3 26.a\ne
2.
This issues with the approval of Director (Cost).
(Raj Kumar)
Under Secretary, to the Government of India
PI-Norms
(Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi.
´
F. No.3 50 1 1 13 18/2013 -PI (Norms)
Government of India
New
Office Memorandum
SutteCt‐ FixaliQn of noms under para 4.7 of Halld B00k of ProcedurOs(Vol.1)2009…
14 Casc Qf M/s.
●
The undersigned is directed to refer to DGFT U.0.No.01/82/50/1331/AM13/DES‐
3/1320 dated
the 18/03/13 vide which representation from M/s. Ranbaxy Labs Ltd was sent to this Department for
flxation of nornls under para: 4.7 for the cxpolt of lrbesartan Tablets/Capsule 75mg, 150mg and
300mg.This department has exanlined the inatter and the fo1lo、
ving nolllls are furnished under para 4.7 of
Hand Book of Procedures(Vol.1)2009-14:―
[A]Norms recommended for lrbesartan
S.No.
Import ltem
l
2-cyano-4-bromomethyl biphenyl
1.04
2.
Acetone
0.303
3.
Diazaspiro hydrochloride (2-butyl- 1,3-diazaspiro(4.4)non-
l -en-4-one hydrochloride)
0.88
4.
Ethyl acetate
2.275
ξ
フ
\4ethylene chloride
1.376
6.
Vlethanol
1.057
7.
Methylt-butyl-ether
0.74
8.
Ioluene
2.789
9.
Iri-n-butvltin chloride
0.691
[B] Norms recommended for Tablets/Capsules
Norms for I No. Tablets
S.No.
lmport Item
75 1ng
150 mg
300 11lg
l
Irbesartan
75.O nlg
150.O lng
300.01■g
2.
This issues with the approval of Director (Cost).
(Raj Kumar)
PI-Norms
(Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi.
Udyog Bhawan,
Delhi. the I l'r' September, 201 3
F. No.350 1 1 I 55012013-PI (Norms)
Government of India
Udyog Bhawan,
New Delhi, the 2l't November,2013
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of
M/s Granules India Ltd.
The undersigned is directed to refer to DGFT U.O.No. 0ll82l50ll224lAM131DES-31291
dated the 26107113 vide which representation from IWs. Granules India Ltd was sent to this
Department for fixation of norms under para: 4.7 for the export of Compresso CIP 65. This
department has examined the matter and the following nonns are furnished under para 4.7 of
Hand Book of Procedures (Vol.l) 2009-14:-
S.No.
Import Item
1
iprofloxacin Hcl
0.757
つ
一
Marze Starch
0.159
3.
Sodhn Stach Gサcdlate ~\
0.040
4.
Povidoneb&o
0.005
5.
Presalatinir.a SXcn
`\\ 0.025
6.
Magnesium St.*ut"\
\ 0・009
7.
\
Silica Colloidal Anhvdrous
\ 0.005
This issues with the approval of Director (Cost).
(Raj Kumar)
Under Secretary to the Govemment of India
PI-Norms
(Shri R.C. Meena, Dy. DGFT), Udyog Bhawan, New Delhi.
F. No.3501 1 17891201 l-Pl (Norms)
Government of lndia
」anpath Bhawan,New Delhi,
Dated:September 25,2017
0ffice Memorandum
Sub:― Fixation of norms― App‖cation of M′ s Jodas ExpOirn Pvt.Ltd.,New Delhi.
The undersigned is directed to refer to DGFT U.O.No.01ノ82/050/129ノAM-17ノDES―
3ノ150 dated 19/06/2017 fon″ arding an application of A/1/s Jodas Expoirn Pvt. Ltd.for fixation of
norms against export of loprornide :niect:Ons in various strengths. 丁his department has
exanlined the rnatter and the fo‖ owing norrlls are furnished:―
2.)
(PaⅣeen Kumar)
Under Secretary to the Government oflndia
E―mall:paⅣeen.19(@9ov.in
Phi-23352298
(Shri S.K. Panigrahi),
Udyog Bhawan, New Delhi.
E-mail. sk. panigrahi@nic.in
Ph: 23061562, Extn.269
Product to be Exported
Raw materials to be lmported
S.No
Description & Pack Size
Quantity
Description
Quantity in
qmlI00 vials
lopromide lniectiOn 240 mg 10dine/ml ln
50 rnl vials
1 00 vials
lopromide
2,618.40 gm
2
lopromide lnjection 300 mg lodine/ ml in
50 mlvials
1 00 vials
lopromide
3,272.80 gm
3.
lopromide lnjection 300 mg lodinei ml in
100 ml vials
1 00 vials
lopromide
6,545.70 gm
4
lopromide lnjection 370 mg lodine/ ml in
30 ml ml vials
1 00 vials
lopromide
2,421.90 gm
5
lopromide lnjection 370 mg lodine/ ml in
50 ml vials
1 00 vlals
lopromide
4,036.50 gm
6.
lopromide lnjection 370 mg lodine/ ml in
100 mlvials
1 00 vials
lopromide
8,073.00 gm
7.
lopromide lnjection 370 mg lodine/ ml in
200 ml vials
1 00 vials
lopromide
16,146.00 gm
8.
lopromide injection 370 mg lodine/ ml in
500mlvials
1 00 vials
lopromide
40365.{5gm
F. No.350 1 1 12041201 7-(Pl-Norms)
Government of lndia
Room no.310, B-wing, 3'd floor,
Dated: November ,2017
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-20
case of M/s Granules lndia Ltd.
The undersigned is directed to refer to DGFT U.O. No. 011821050/01290/AM-
17IDES-3/1158 dated the 2313117 vide which application from M/s Granules lndia Ltd.
was sent to this Department for fixation of norms under para: 4.7 for the export of
Compresso GEM 70 (Gemfibrozil Granules DC 7A%1. This department has examined
the matter and the following norms are furnished under para 4.7 of Hand Book of
Procedures (Vol. l) 201 5-20:-
2.) This issues with the approval of competent authority.
(Parveen Kumar)
Phone:23352298
Email: parveen. 1 9@oov.in
Shri S.K. Panigrahi, Economic Officer, DES-Ill
Udyog Bhawan, New Delhi-1 1001 1
Email: sk.paniqrahi@nic.in
S
.
N
。
lmport item
Norms Recommended for
1kq Export
Gemibrozil
0.707kq
2
Preqelatinised starch
0.083kq
3
Maize starch
0 1485kq
4
Sodium starch olvcollate
0.030kq
5
Povidone
0.027kq
6
Sodium lauryl sulphate
0.001 5kg
7
Stearic acid
0 010kq
⌒
F観品恵
HQ File
:01/82/050/01227/AM13/
Party Name:SARNA
Mcet No/Date:2/82‐
CHEMTCALS PVT.LTD. l1ttcuzo3
apprOprlate
tion as per the decision of NormiCommittee.
Decision :In the light of writteniomrnents &,i.-d f."; o.prrt.*i "rjr,..i*r. *a
Petrochemicals vide their U.o No. 14010/4gl200g-ch. II dated ll.4.2ol3,it was decided
to ratifu norrns under Pata 4.7 of HBP vl as per details grr., below or as applied by the
firm, whichever is less:
Export product
Exp
Qty.
SI.No.
tmport items
Qty. allowed
2-(2-Amino ~
Ethoxy)‐2-Ch10rO
Diethyl
Sulfone/Ethermaine
l kg
2‐Amino Ethoxy Ethanol
■874 kg
2
2-Mercapto Ethanol
0.800 kg
3
Caustic SoOa (tOOoZ.)
0 850 kg
may takc
ac
、ノ
F. No.350 1 1 18251201 5-Pl (Norms)
Government of lndia
Udyog Bhawan, New Delhi,
Dated: 1 June, 2016
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14
Case of M/s Ami Life Sciences Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O.No. 0118215010002/AM-
17IDES-3/94 dated the 1115116 vide which application from M/s Ami Life Sciences Pvt.
Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of
Diacerein. This department has examined the matter and the following norms are
furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:-
(Rajkumar)
PH:- 23071162
S.No.
lmport item
Norms Recommended
for 1kq Export
1
Aloe emodin 95%
1.05kq
2.
4.,
F. No.350 1 1 I 12212014-PI (Norms)
Government of India
Udyog Bhawan,
New Delhi, the
October, 2014
Offrce Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand g*k of procedures (Vol.l) 2OOg-14 Case of
M/s Honest Bio-Vet pvt Ltd.
The undersigned is directed to refer to DGFT u.o.No. 0llgzl5ol993lAM-l4lDES-3i I155
dated the 16101114 vide which application from M/s. Honest Bio-Vet Pvt Ltd was sent to this
Department for fixation of norms under para: 4.7 for the export of Menadione Dimethyl
Pyrimidinol Bisutphite (Feed Supplement). This department has examined the matter and the
following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:-
S. No.
Import ltem
l
Menadione Sodium Bisulphite (feed grade 94%)
0.918
2.
Acetyl Acetone
0.40
3.
N- Butanol
0.40
This issues with the approval of Director (Cost).
(Barnali Khastgir)
F. No.350 1 I 17212014-PI (Norms)
Government of India
Udyog Bhawan,
New Delhi, the 21't Aprrl,2}l4
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case
of M/s Brundavan Labs Pvt Ltd.
The undersigned is directed to refer to DGFT U.O.No. 0l/82l50l89llAM-L41DES-
311076 dated the 3lll2ll3 vide which application from M/s. Brundavan Labs Pvt Ltd was sent
to this Department for fixation of norns under para: 4-7 for the export of 4-Hydroxy
Carbazole. This department has examined the matter and the following norrns are furnished
under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 -
(Barnali Khastgir)
PI-Norms
Import Item
Qty. Recommended kdkg.
Hydrazine Hydrochloride
This issues with the approval of Director (Cost).
F. No.350 1 1 111012017 -Pl (Norms)
Government of lndia
Room no.310, B-wing, 3'd floor,
Dated: November ,2017
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-
20 case of M/s Orch Laboratories lndia Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O. No. 011821050/00233 &
00325 & 337/AM-18/DES-3/ dated lhe 141612017 & 211912017 vide which application
from M/s Orch Laboratories lndia Pvt. Ltd. was sent to this Department for fixation of
norms under para: 4.7 for the export of 4-Amino-2-Oxo Pyrimidinyl Oxathiolane-2-
Carboxylic Acid-lso Propyl Methyl Cyclo Hexyl Ester (Cyclohexyl Ester). This
department has examined the matter and the following norms are furnished under
## para 4.7 of Hand Book of Procedures (Vol.l) 2015-20:-
2.)
(PaⅣeen Kumar)
Under Secretary to the Government oflndia
Phone:23352298
Email:paⅣeen.19ΩoOV.in
Shri S.K. Panigrahi, Economic Officer,
Udyog Bhawan, New Delhi-110011
Email: sk.paniqrahi@nic. in
DES― |‖
S.No.
lmporl item
Norms Recommended
For 1kq Export
Glvoxvlic Acid 50%
0.743kg
2
L(―)MenthOI
0.751kg
3
Cvclohexane
0.790kg
4
2, 5-Dihydroxy 1,4-Dithiane
0 327kg
5
Cytosine
0.428kg
6
Hexamethyl Disilazane
0.698kg
7-
…
F. No.350 1 1 111012017 -Pl (Norms)
Government of lndia
Room no.310, B-wing, 3'd floor,
Dated: November ,2017
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-
20 case of M/s Orch Laboratories India Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O. No. 011821050/00233 &
00325 & 337/AM-18/DES-3/ dated lhe 14tG12017 &211912017 vide which application
from M/s Orch Laboratories lndia Pvt. Ltd. was sent to this Department for fixation of
norms under para: 4.7 tor the export of 4-Amino-2-Oxo Pyrimidinyl Oxathiolane'2'
Carboxylic Acid-lso Propyl Methyl Cyclo Hexyl Ester (Cyclohexyl Ester). This
department has examined the matter and the following norms are furnished under
## para 4.7 of Hand Book of Procedures (Vol.l) 2015-20:-
2)
(Parveen Kumar)
Phone:23352298
Email: perrveen. 1 9@qov.in
Shri S.K. Panigrahi, Economic Officer,
Udyog Bhawan, New Delhi-1 1001 1
Email: sk. paniqrahi@nic. in
DES― l‖
S. No.
lmport item
Norms Recommended
For 1kq Export
1
Glvoxvlic Acid 50%
0,743kg
2
L(―)MenthOI
0.751kg
3
Cyclohexane
0.790kg
4
2, 5-Dihydroxy 1,4-Dithiane
0.327ks
5
Cytosine
0.428kg
6
Hexamethyl Disilazane
0 698kq
7
Methvlene dichloride
1.56kq
F. No.3501 1/1 1 0/201 7-(Pl-Norms)
Government of lndia
Room no.310, B-wing,
Dated: October25,2017
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 20't5-
20 case of M/s Orch Laboratories lndia Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O. No. 0118210501011571AM-
17|DES-31944 dated the 101212017 vide which application from M/s Orch Laboratories
Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the
export of 4-(Sulphamoyl Phenyl) Hydrazine Hcl. This department has examined the
matter and the following norms are furnished under para 4.7 of Hand Book of
Procedures (Vol.l) 201 5-20:-
2.) This issues with the approval of competent authority.
(Parveen Kumar)
Phone: 23352298
Email: parveen.l 9@qov. in
Shri S.K. Panigrahi, Economic Officer, DES-Ill
Email: sk.paniqrahi@nic.in
S. No.
lmport item
Norms recommended
for 1 kq export
1
Sulfan‖amide
0.96kq
2
methanol
0.48kq
ハ
髪
|‐
Meet No/Date:19/82‐
ALC4/2013
諸∬淵
Tま0310翫「
~1需
ざ
| |
decision of Norms Committee.
02.01.2014
ion : tn the tight of written .orr"ntr.;;il1;;;t
nr";i;i6[ri."r, ,;J
:hemicals vide their U.o No. 1.401o/6t/2013-ch l dated og.ot.2oL4,it was decided to ratify
I under Para 4'7 of HBP v1 as per details given below or as applied by the firm, whichever is
less:
Export product
Exp.
Qty.
Si.No.
lmpOrtたems
Qty. allowed
AMINOSoL CST l15
l kg
1.
PIPERAZINE(N,N‐
IAMINE)68%
0.227 kg
nay raKe appropriate action as
the
No。:14/14/82‐ALC4/2013
Name:AMINES&
1198掲50/00599/AM14/
ばよ
ぃ
イ
287/
一
Fo No.350H/80/2010… PI(NollllS)
Goverrment oflndia
Ministry ofCherrlical&Fertilizers
Department ofPharrnaceuticals
Udyog Bhawan,
New Delhi,the lSt(Dctober,2010。
Offlce Memorandum
Sub:Fixation of nollllS under para 4.7 of Hand Book of Procedures(Vol.1)2009-
14 Case ofM/S Do l―Rc`ごお`熱Ьバ
The undersigned is directed to refer to lDGFT u.ooNo.01/82/50/298/AMl1/DES―
囃
為
器
繊
露
蹴Fl譜
ゝr認
胤
Tぶ
■聡
para:4.7 for the export of(2R― CIS)-5-(4¨AMINO‐ 1,2-DIHYDRO-2-OXO-1…
PYRIMIDI― )-1,3-OXATⅢOLANE¨2-CARBOXYLIC ACID (2S,5R)―
METIWL ESTER.This department has examined the lrlatter and the following
comments under para 4.7 ofHand Book ofProcedures(Vol。1)2009-14:…
S,No。lmport ltem
Qty. Recommended ke/kg.
1.
GLYOXAuC ACIヮ50°/0)
僻"0113
多
qL暉耳コ画
=コ
平R平7輌再爾〕t
仙士翻並呻璽璽丞ittm
Tハ
n hE
‐0-
一
尋
書
理
壇
璽
≡
夏
=望
三
l_____一
一
一
一
一
4.
SODIUM BISULPHITE
餅α;8 o.63η
ー
8鋭洲開昨0叩09酵汀E _
喘
A
協
7.
2′ 5 DIHYDROXY-1′ 4-DIETHANE
暉
〇・ろhヽ
Ω
m
9.
TRIEttHYL Aヽ川NE
∝″ 〇`03句
10。
DI MEttHYL FORMAMIDE
0.23 レ
11.
HEXA METHYL DISILIZANE
0。752-
メ
メ
‐
´
~~~~~~一
―
―
´
⌒
This issues with the approval of Deputy Director General.
(Shri Shyam Lal, FTDO), Udyog Bhawan, New Delhi.
N.N.Ahtta
Section(Dfflcer
(PI…NORMS)
■つ
コ剛旧閥Ⅳ
「
日副
∩DIFヽE
呼
13.
METHANE SULPHONIC ACID
0.01 じ″
14.
CWOSINE
0。455 け
lE
…
16.
TOLUENE
1.82 レ
17.
N―HEXANE
3.00 レ/
1只
一
19
METHYLENE DI CHLORIDE
2.03 レ
″
F.No.35011/40/2017¨ Pl(Norms)
Government oflndia
即μ
Room No. 302, 3d Floor,
JanPath Bhawan New Delhi'
Dated: November 8,2017
Office Memorandum
Sub.-Fixationofnormsunderpara4.7@adilaHealthcareLtd'
The undersigned is directed to refer to DGFT u.o. No' o1l82t5olo0939/AM-17/DEs-3 /805
dated the 28/1 2t2[16vide which anLpptication from rrrr[. caoila Healthcare Ltd' was sent to this
Department for fixation of norms ,gri;; export of pravastatin sodium 10mg, 20mg, 40mg and
g0mg Tabrets. This department has examined the ,rtt"r rnd the foilowing norms are furnished
based upon the DML;;'d composition details provided with the application.
of l No' Tablet
S.
No
lmPort item
ffi
10mg
20mg
40mg
oumg
40.80 rng
81.60 rng
10.20 rng
20.40 rng
1
258.00 rng
32.25 rng
64.50 rng
129.00 rng
2
ヽlinrocrvsta‖ ine(じe‖ u10Se
409.94 rng
I aetnse Anhvdrous
31.24 rng
102.48 rng
204.97 Fng
3
X
/
/
′
ヽ
4
αミCC llVhtte HDPE BOttle
益
\/
X
X\
5
6.
7.
100じS゛Ⅳnlle HりrE DυLuC
X\
K
nDE Oハ
++l●
\
/
一
X
lЭUししVⅦ製Lじ「
/\
X
DPE Bottle
X\
ヽ
X
\
X
X
/`
8.
HNE BOttl呈
/
/
\ X
9
10.
::ヽ
′
33 ⅣliV卜4UUしdν わL‖ ヽ
\X
X
\ /
38 MM400 CaPs Line\
X
\/
X
\X
∩△p3R MM PP Wnh PULlミLiner
/
ヽ
M八
X
\
/
12.
/
一
X
/
/\
13.
Packing:nsert PraVastatin sOdlum
Tablet _
equired
2.
The inputs from s' no' 4 to 13 are packing^Yflflt and maY be Permitted as Per DGFT's
亀cttn」品‖どIIまし晶
ILqttЮd as pahe aboVeねЫQ
3
This issues with the approval of competent authority'
((Parveen Kumar)
Under secretary to the "Hffi:iiSi|rta
Email: Parveen. 1 9@gov'in
Directorate General of Foreign Trade'
(Shri Panigrahi, DY DGFT), ..
h;; No.-+1+, UdYog Bhawan, New Delhi
十
ご
枷
F. No.3501 1146812014-PI (Norms)
Government of India
UdYog Bhawan,
New Delhi, the
FebruarY,2015
Office Memorandum
Sub: Fixation of norms under para 4.7 or Huna gook oiprocedures (vol.l) 2oog-14 case of M/s' Atul
Biosciences Ltd.
The undersigned is directed to refer to DGFT U.o.No. 011921501574,515,573/AM15/DES-
3/51g,513,514 dated-th e [2logll4vide which an application from M/s. Atul Biosciences Ltd was sent to this
Department for fixation of norms under para: 4.7-for the export of N-Benzyloxycarbonyl-L-valine (cBZ'
L-VALINE). This department has examined the matter and tlhe following comments are furnished under para
4.7 of Hand Book of Procedures (Vol'l) 2009-14-
2.
This issues with the approval of Director (PI)'
(Barnali Khastgir)
Phone- 23011162
(Shri M.V. Singh, FTDO).
0.510
-----
oA4
S. No.
Imporl ltem
L-Valine
Heptane
1
つ
4
F. No.3 50 I t I 620 1201 4-PI (Norms)
Government of India
DePartment of Pharmaceuticals
New Delhi, the
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures
CaseoflWs@
The undersigned iS directed to refer to DGFT U.0.No.01/82/50/1159/AM-15/DES―
3/932 dated the 01/01/15 vide which application froII
Ⅳ1/S.Enaltec Labs Pvt Ltd was sentto
this Department for ixation of nonns under para:4.7 for the export of Febuxostato ThiS
depa■ment has examined 19,atter and the fol10Wing norms are fumished under para 4.7 of
Hand Book ofProcedures(V01.1)2009-14:―
揃
3メ
Udyog Bhawan,
April, 2015
(V01。1)2009-14
ノ
´ ~‐
lmport Item
.勢2 いヘ
@ropoxy)
PhenYll -4-MethYl- 5 -
iazolecarboxylic Acid Ethyl Ester
2.
This issues with the approval of Director (PI)'
(Barnali Khastgir)
Phone- 23071162
奮
F No 35011/825/2015-PI(Norms)
Government oflndia
Ministry of Chemical&Fertilizers
Department of PharmaceutlCals
udyog::雷1褻,現1:
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol l) 2009-14 case of
M/s@.
The undersigned is directed to refer to DGFT U.O.No. O1tB2t5Otoo02lAM-17/DES-3/94
dated the 11tst1o vioe *niJ lpprL"tion r., utls Ami I-ife
Sciences Pvt Ltd was sent to this
Department for fixation "f ;;;.;;;;t-para. 4.7 for the export of Diacerein. This department has
examined the matter and the following norms are furnished under para 4.7 of Hand Book of
Procedures (Vol.l) 2009-1 4:-
2
This issues with the approval of competent authority'
(Ralkumar)
under Secretary to the Government oflndia
PH: 23071162
Directorate Genera1 0f Foreign Trade,
Depanment Of COmmerCe,
剛yよ鼎:l返P晶lh
13甲
Norms Recommended
for 1kg ExPort
Aloe emOdin 95%
⌒
F. No.350 1 | 18812013-PI (ltiorms)
Government of India
Department of Pharmaceutical s
Udyog Bhawan,
Nc、v Dclhi,thc lSt April,2013
Offlce Memorandum
SuЦ eCt:― Fixttion of norlns undcr para 4.7 of Halld Book of Procedures(VOl・1)2009-14 Casc of M/S
Thc undcrsigned is dirccted to rcfer to DGFT U.0。
No.01/82/50/821/Aヽ413/DES-3/937 dated thc
15/11/12 vide 、vhich an application froln M/s. Aurobindo Pharma Ltd was scnt to this Depaltment for
flxation of norllns under para: 4.7 for the export Of Cefotaxirne Sodium Sterile. This departincnt has
examined the matter and thc fo1lo、ving coFninents are fumishcd undcr para 4.7 of Hand Book of Procedurcs
(V01・1)2009-14:―
S.No.
Import Item
1
cfotaxime Acid
0.989
2.
\ethylamine
\
0178
3.
`ヽ
「
~可
T百ウそ
4.
\1型
理
5.
Methyl Iso\yl Ketone
雫
6.
Activated Car\
爾収
7.
2-Ett yt Hexanoic \d
R.t.*rt, At per Pack[ng PolicY.
8.
Al. Canisters \
2.
This issues with the approval of Director (Cost)'
(N.N.Ahuia)
Scction Offlcer
PI―Norms
(Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi'
F. No.350 1 | l3l5 12014-PI (Norms)
Government of India
W
7et
v---
UdYog Bhawan.
New Delhi, the March, 2015
Offlcc NIlcmorandum
sub: F破江ion of noms undcr para 4.7 of Hand Book of Proccdures(Vol・
り2009-14 Case of M/S.Unimax
Chemicals Pvt Ltd.
The undersigned is directed to rcfer to DGFT U.O.No.01/82/50/165/AⅣl15/DES-3/dated the
08/09/14 vidc、vhich an appliCation fl・olll lV1/S.Unirnax Cherllicals Pvt Ltd、
vas sent to this Departrnent lor
雉∫盟訊
lぎ胤胤t鰤よ駆¶』認myttЛ7:I官淵l謂霧Ⅷ鳳詰郷
2009-14:―
2.
This issues with the approval of I)irector (PI)'
(Barnali Khastgir)
Phone- 23071162
Export Product
Azithromycin Dihydrate USP-?6------------- I kg
Import Recommended
Azithromycin Dihydrate IP… ……三~~~~~-1工
`襲
唱/kg 、ヽもЦ Ц
366
F. No.350 11 18641201 s-Pl (Norms)
Government of lndia
Shastri Bhawan, New Delhi,
Dated: APril 10,2017
Office Memorandum
Sub: - Fixation of norms under para 4.7- Application of M/s Mangalam Drugs & Organics Ltd., Vapi
for export of Artemether-an anti-malarial drug'
The undersigned is directed to refer to DGFT U.O. No. 01t82t5}l}1646/AM16/DES-3/1762 dated
02.03.2016 and subsequent letter from M/s Mangalam Drugs & Organics Ltd, for fixation of norms
against export of Artemether-an anti-malarial drug. lt may be recalled that following norms were
earlier recommended against some ot these appllcatlons.
S.No.
lmport ltem
Norms applied kg/kg
Norrns Reco,(リアnded f°rlkg
1
Artemisinin
1.35
1.235
2
Sodium BorohYdride
0.22
0188
3
Trimethyl Ortho Acetate
1.75
0.50
ed aqai
of these applications
rtho Acetate (TMOA) and
have requested to increase it to 1.75 kg/kg as against 0.50 kg allowed against 1 kg of Artemether'
3) Technical examination: (i) The manufacture of Artemether (M.w 298) from Artemisinin (M'W
2g2) is essentially a two stage process. ln the first stage Artemisinin is reduced to get Dihydro
Artemisinin (M.w 2g4). g0.3% yield is claimed by the applicant in this stage. During second stage
TMOA is used to convert Dihydro Artemisinin into Artemether crude with 84.4 % reported yield' The
crude end product is subjected to purification and 91.4 % yield is reported by the applicant'
considering the percentage yields obtained at each stage by the company only 0'52 kg TMOA is
the calculated requirement for 1 kg Artemether. Furthermore, in all other applications from other
companies not more than 0.50 kg TMOA has been allowed.
4) The norms allowed for the export product were also based upon roughly same levels of yields
obtained in manufacture of Artemisnin. The DoP has considered 90% optimum yield in first stage,
85% yield in second stage and 95% yield in the purification stage'
5) ln view of the above, there is no justification for upward revision of TMOA consumption norms
allowed against this aPPlication
6) This issues with the approval of competent authority
(Barnari Khastgir)
Phone: 23323292/Email : barn. khast@ n ic' i n
(Shri Nirmal Kumar, DY DGFT),
Email: nrrmal.kuma165@nic.in
ek
F. No.350 1 1 18631201 5-Pl (Norms)
Government of lndia
3年
Udyog Bhawan, New Delhi,
Dated: 18 MaY, 2016
Office Memorandum
## subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 case of
@
The undersigned is directed to refer to DGFT U.O.No. 01t82t50t1596/AM-16/DES-3/1765
dated lhe 2t3116 vide which application from M/s Rnur, pnarma Ltd. was sent to this Department for
fixationofnormsunderpara:,+.7fortheexportofMometasoneFuroateffiiS
department has examined the matter and t'he following norms are furnished under para 4'7 of Hand
Book of Procedures (Vol.l) 2009-14:'
This issues with the approval of competent authority'
(Rajkumar)
PH'- 23071162
2
Norms Recommended for
1kg Export
TO-Rtpfra methyl EPoxide/8DM
F. No.350 11 t1551201 6-PI (Norms)
Government of lndia
UdYog Bhawan, New Delhi,
Dated: SePtember,2016
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (vol.l) 2009-14 case of
M/s Strides Shasun Ltd.
The undersigned is directed to refer to DGFT U.o.No. 01t82l5ot185/AM-17/DES-3/183
dated the 4t7116 vidie which application from M/s Strides Shasun Ltd. was sent to this Department
for fixation of norms under paia, 4.7 lor the export of Metoprolol rartrate Tablets USP 25mg'
This department has examined the matter and the following norms are furnished under para 4'7 of
Hand Book of Procedures (Vol.l) 2009-14:-
lmport item
Metoprolol tartrate
Norms Recommended
S.No.
25.50m9
1
一
2
一
3
Magnesium stearate
1.49m9
trlticrocrvstalline cellulose (avicel 1 02)
75.21m9
Croscarmellose sodium
11.92m9
4
Lactose anhYdrous
ffi
33.62m9
5
Relevant, as Per Packing PolicY
6
2.
This issues with the approval of competent authority'
(Rajkumar)
PH'.- 23071162
(Shri M.V. Singh, FTDO)'
Udyog Bhawan, New Delhi.
⌒
F No 35011ノ151/2016-Pi(Norms)
Government oflndia
Ministry of Chemical&Fertilizers
Udyog Bhawan,New Delhi,
Dated: August,2016
Office Memorandum
Subject. - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol'l) 2009-14 Case of
M/s U Square Life Sciences (P) Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01lB2l50l190lAM-17iDES-3/185
dated the 4t7lj6 vide which application from M/s U Square Life Sciences (P) Ltd was sent to this
Department for fixation of norms under para: 4.7 for the export of clindamycin injection
60omg/4m1. This department has examined the matter and the following norms are furnished
under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:-
S No
lmport item
Norms Recommended
1
Clindamycin phosphate us/
784 22mg/vial
つ
4
This issues with the approval of competent authority'
(Ralkumar)
Under Secretary to the Government oflndia
PH■23071162
Directorate General of Fore19n Trade,
Depattment of Commerce,
(Shl M V Singh,FTDO),
Udyo9 Bhawan,New Delhi
鉾
F No 35011/704/2015-PI(Norms)
Government oflndia
Ministry of Chemical&Fertilizers
Department of PharmaceutiCals
Udyog Bhawan, New Delhi,
Dated: 29, APril 2016
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol l) 2009-14 Case of
M/s FDG Ltd.
The undersigned is directed to refer to DGFT U.O.No. O1l12l50l1001lAM-16/DES-3/1 '129
dated the 26111t1i vide which application from M/s FDC Ltd. was sent to this Department for
fixation of norms under para: 4.i ior the export of Chloramphenicol Eye Drops 0'5% WV of
i0ml. This department has examined the matter and the following norms are furnished under para
4.7 of Hand Book of Procedures (Vol.l) 2009-'14:-
S No
lmport ltem
Norms Recommended
1
Chloramphenicol (Micronized)
0 0525gm/10ml pack
2
This issues with the approval of competent authority'
(Ralkumar)
Under Secretary to the Government oflndia
PH■23071162
Depanment of Commerce,
(shn M∨singh,FTDO),
Udyog Bhawan,New Delhi
ハ
3多
389
F. No.350l 1 I 19812014-PI (Norms)
Government of lndia
Ministry of Chemical& Ferlilizers
UdYog Bhawan.
New Delhi, the October,20l4
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (vol.l)2009-14 case of M/s Nectar Life Sciences Ltd'
The undersigned is directed ro refer ro DGFT U.o.No. oll82l5ol1l79lAM-l4|DES-3/1391 dated the 24103114 vide which
application from M/s. Nectar Life Sciences Ltd was sent to this Department for fixation of norms under para: 4.7 fot the export of
cefixime Trihydrate. This department has examined the matter and the following norms are furnished under para 4'7 of Hand
Book of Procedures (Vol.l) 2009-14:-
S. No.
Import Item
L
一
2
GCLE
1 507
Sodium bromide
0.3628
3
.
一
4
.
Iri Phenyl Phosphine
0.820
DMF
1.869
Methylene Chloride
1546
6
.
一
■
一
&
Formaldehyde
1.H8
Methanol
5117
lhenol
0.3808
9
.
一
1
0
.
Butyl Acetate
0302
Eno Carbon
0100
趾
一
2
一
」
A.cetone
0793
MICA Ester
0.820
lriethylamine (TEA)
0.2717
This issues with the approval of Director (Cost)'
(Barnali Khastgir)
Under Secretary to the Covernment of India
Departnrent of Commerce,
霧
F. No.350 11 16141201 5-Pl (Norms)
Government of lndia
Deparlment of Pharmaceuticals
Udyog Bhawan, New Delhi,
Dated: 19 February, 2016
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 case of
M/s
The undersigned is directed to refer to DGFT U.O.No. 01l82l51t1'180/AM-16/DES-3/1501
dated the 12t1t1o rioe which application from M/s.JndePhytsGnernieals-Pv| Ltd' was sent to this
Department for fixation of norms under paru'.4.7 lor the export otott4?stlel**ll-Drug' This
department has examined the matter and the following norms are furnlEhed under p-ararlTicf Hand
2009-14
Rnnk n Procedrrres (Vol
S.
No.
lmport ltem
Norms Recommended for
1kg Export
1
.
一
2
.
一
3
.
Lactone(D)
1.95k9
C fr t o ro t<et IZ - ( 3 -C h I o ro p ro py I ) -2, 5, 5 -T ri m eth y I -
1,3-Dioxane
1 .81k9
Tetrahydrofuran
5.80k9
2
This issues with the approval of competent authority'
(Rajkumar)
W
F. No.35011123312013-PI (Norms)
t . ^
Government of India
7ff1
Ministry of Chemi cal &Fertilizer
---
Udyog Bhawan,
New Delhi, the 03th JulY, 2ol3
Office Memorandum
## Subject: - Fixation of norms und.. pu* 4,.7 of Hand Book of Procedures (Vol.l) 2009'14
Caseof@.
The undersigned is directed to refer to DGFT U.O.No. Oll82l50ll054lAMl3/DES-
311221 dated the 26102/13 vide which an application from lr4/s, tr"ncure Pha"rnaLtd was sent
to this Department for fixation of norms under para:4.7 for the export of colistimethate for
lnjection usp 150 ,glYli#department has examined the matter and the following norms are
furnished under para 4.7 of Hand Book of Procedures (vol .l) 2009-14-
S. No.
1.
Import Item
Qty. Recommended.
Colistimethate Sodium USP/EP
403.85 mg/vial
2.
Vial
Relevant, As Per Packing
policy.
3.
Stopper
4.
Aluminium Seal
2.
This issues with the approval of Director (Cost)'
(Raj Kumar)
PI-Norms
(Mrs. Lalita Maini, FTDO),
Udyog Bhawan, New Delhi.
416
F. No.350 11 137912016-Pl (Norms)
Government of lndia
Room No. 302, 3'd Floor,
Janpath Bhawan New Delhi,
Dated: September 6, 2017
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of
M/s J.B. Chemicals & Pharmaceuticals Ltd.
The undersigned is directed to referto DGFT U.O. No. 01t821050/00660/AM-17/DES-|lll552
dated the 03/1 ot2o16 vide which application from M/s J.B. Chemicals & Pharmaceuticals Ltd'
was sent to this Department for fixation of norms for the export of various medicated throat
lozenges containing Benzocaine as one of the APl. This department has examined the matter
and the following norms are furnished against the export item:
Product to be Exported
Raw materials to be imPorted
Description
Qυanlily
Description
Quantity in gm
Benzoca'lne and Getylpyridinium Chloride
Anesthetic Throat Lozenges Flavours Black
Current, Honey Lemon & Other Flavours (Each
lozenge contains Benzocaine 12 mg)
1000
1ozenges
Benzocaine
12.240 gm
genzocaine anO Cetylpyridinium Chloride
Anesthetic Throat Lozenges Flavours lime and
lemon and Other Flavours (Each lozenge contains
Benzocaine 10 mg)
1000
:ozenges
Benzocaine
10.20 gm
ffiinium
chloride and
Dextromethorphan Hydrobromide Anesthetic
Throat Lozenges (Each lozenge contains
Benzocaine 1.25 mg)
1000
1ozenges
Benzocaine
1.275 gm
2.
(Parveen Kumar)
Phone.23352298
Email: parveen.l 9@qov.in
(Shri S.K. Panigrahi, Economic Officer, DES-Ill
ihone No: 23061562, (269), Udyog Bhawan, New Delhi
Email: sk.panigrahi@nic.in
,.\
F. No.3501 | I 145 12014-PI (lt{orms)
Government of India
Department of Pharmaceutical s
グ
叩
UdYog Bhawan,
New Delhi, the
October, 2014
Office Memorandum
## Subject: - Fixation of norms under puru4.7 ,f Hund Book of Procedures (vol.l) 2009-14 case of M/s IPCA
Labs Ltd.
The undersigned is directed to refer to DGFT U.o.No. oll82l5oll198/AM-14IDES-311329 dated the
lglo3ll4vide which application from M/s. IPCA Labs Ltd was sent to this Department for fixation of norms
under para: 4.7 for the export of paroxetine Hydrochloride Hemihydrate. This department has examined
the matter and the following norrns are furnished under para 4.7 of Hand Book of Procedures (Vol'l) 2009-
l4:-
This issues with the approval of Director (Cost)'
(Barnali Khastgir)
-1 f*,ls+n-(4-Fluorophenyl)-3 S-hydroxymethyl-N-
ethyl Piperidine
yl Sulfoxide
S. No.
Imporl ltem
1.
,.
;J.
0.810
iesamol
0.55
2.9293
F
6Dw
F. No.3501'1/27812016-Pl (Norms)
Government of lndia
Dated: September 15, 2017
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-20 Case of
M/s Sentiss Pharma (P) Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01l82l5Ol430lAM-17lDES-31425
dated the 1glOBt2O16 vide which application from M/s Sentiss Pharma (P) Ltd. was sent to this
Department for fixation of norms under para: 4.7 for the export of Kombinil-Duo Eye/Ear Drops
Sml vial. This department has examined the matter and the following norms are furnished under
## para 4.7 of Hand Book of Procedures (Vol.l) 2015-20:-
S.No.
lmport item
Norms Recommended
1
Dexamethasone (l{iceaizedJ.JsPf
5.'tmg/Sml pack
2)
(Parveen Kumar)
Phone: 23352298
Email: parveen..1 9@qov. in
(Shri S.K. Panigrahi, Economic Officer, DES-Ill
Email: sk. paniqrahi@nic. in
.jx
\e3
F. No.350l ll19612014-PI (Norms)
Government of India
Udyog Bhawan.
New Delhi, the October, 2014
Offrce Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s
Danopharm Chemicals Pvt Ltd.
The undersigned is directed to refer to DGFT U.O.No. 0118215011066lAM-L41DES-3/1389
dated the
Z4l03ll4 vide which application from M/s. Danopharm Chemicals Pvt Ltd was sent to this Department for
fixation of norms under para: 4.7 for the export of l-(4 Methyl Phenyl)-4,4,4 Trifluorobutane-l,3-Dione.
This department has examined the matter and the following noffns are furnished under para 4.7 of Hand
Book of Procedures (Vol.l) 2009-14:-
S. No.
hnporl lten'r
1
l methyl acetophenone
0.67
つ
4
frifluoro acetic acid
0.67
3.
Iso propyl alcohol
0.523
4.
Ioluene
0.46
5.
Sodium methoxide powder
0.346
This issues with the approval of Director (Cost).
(Barnali Khastgir)
F.No.35011′404′2016‐P!(Norms)
Government oflndia
Ministry of Chemical&Fertilizers
Department of Pharrnaceuticals
′
サセ
Room No. 310, 3td Floor, B-Wing,
JanPath Bhawan New Delhi,
Dated: SePtember 26, 2017
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-20 Case of
M/s Zim Laboratories Ltd.
The undersigned is directed to refer to DGFT U.O. No. 01t821050/00061/AM-18/DES-Illl131
dated the 1410612017 vide which application from M/s Zim Labs Ltd. was sent to this Department for
fixation of norms for the export of Nicardipine Hydrochloride Sr Pellets 50 mg. This department
has examined the matter and the following norms are furnished against the export item:
Product to be Exported
Raw materials to be imPorted
Description
Qυ anfily
Description
Quantity
Nicardipine Hydrochloride SR
Pellets 50 mg (230 mg SR Pellets
contain 50 mg NicardiPine
Hydrochloride)
l kg
暇温
ll器de cグ
0.2196 kg
2)
(Parveen Kumar)
Phone:23352298
Email: parveen. 1 9@gov. in
(Shri S.K. Panigrahi, Economic Officer, DES-Ill
Email: sk.paniqrahi@nic.in
句昴絲
'!^
F.No.350'1 1141412016-Pl (Norms)
Government of lndia
Shastri Bhawan, New Delhi,
Dated: SePtember 8, 2017
Office Memorandum
Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14,
Application of M/s Cadila Healthcare Ltd.
The undersigned is directed to refer to DGFT U.O. No. 011821501719/AM-17/DES-3/623
dated the23t11t21i6 vide which an application from M/s Cadila Healthcare Ltd. was fonruarded to
this Department for fixation of norms for the export of Mebeverine Hcl 200m9 Tablets. This
department has examined the matter and the following norms are recommended against this
application:-
S.No.
Import Product
Norms Recommended
1
Mebeverine Hcl BP
204mgper tablet
2.) This issues with the approval of competent authority.
(ParVeen Kumar)
Under Secretary to the Govemment oflndia
E―mail:paⅣeen。19@gov.in
Ph:-23352298
(Shri S.K. Panigrahi),
Udyog Bhawan, New Delhi.
E-mail : sk.panigrahi@nic. in
Ph:23061562,Extn.269
`0
■
―
リ
F.No.7/309/2017-TSw
MihistrソOf COmmerce&lndustry
DEPARttMENT OFINDUSTRIAL POLICY&PROMOTION
(TOllV―
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R6fi bGF↑001N6101/82′66o,ブ72/AMl14/DttStti1/45 aatさdё.d2647 1 1
The norms for export of Di_ propyl
Department of C&pC as under :-
Heptyl Phthalate was fixed by
‐
「he firrn has reqo9,led fOr cOrrection Of oecOnd irnpOrt itき品 ||。h
Eli_・hat:laliC Anhydlide tO Phthaiic Anhydrid6.
It has been observed that in the past norms for the same export prorJuct
rvtrs fixed in meeting no. 46 dated 1s.2.201.r ailowing pnirrrri. nnilorio". rn
a'idition to this, as per rrc (HS) code no.2g173500 the item i, pntnrri.
",:'jJj'l* J:' ::j 1,:311fl311]; .
rr =rrcgJo ! " ?_typesrslsar eirer_n_e e
-31g'g "oj.T and correct nomencralrlrGlnnaric Amffi:G*r" hij;
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19,07.2017
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ExpOrt
Quantttv
SI.
No.
lmpOtt ke品s
Qty.allowed
pi■Propyl
Heptyl
Phthalate
l kg・
Pr≦狙墜I Heptan。
|
0.746 kgi
2
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0.350 Кo
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F. No.350 1 1 18641201 5-Pl (Norms)
Government of lndia
Shastri Bhawan, New Delhi,
Dated: April 10,2017
Office Memorandum
Sub: - Fixation of norms under para 4.7- Application of M/s Mangalam Drugs & Organics Ltd., Vapi for
export of Artemether-an anti-malarial drug.
The undersigned is directed to refer to DGFT U.O. No. 01182150101646/AM16/DES-3/1162 dated
02.03.2016 and subsequent letter from M/s Mangalam Drugs & Organics Ltd, for fixation of norms
against export of Artemether-an anti-malarial drug. lt may be recalled that following norms were
earlier recommended against some of these applications.
S.No.
lmport ltem
Norms applied kg/kg
Norms Recommended for 1kg
Artemether
Artemisinin
1.35
1.235
2
Sodium Borohydride
0.22
0.188
3
丁面methv1 0rtho Acetate
175
050
2) The applicant has represented against reduced quantity of Trimethyl Ortho Acetate (TMOA) and
have requested to increase it to 1.75 kg/kg as against 0.50 kg allowed against 1 kg of Artemether.
3) Technical examination: (i) The manufacture of Artemether (M.W 298) from Artemisinin (M.W 282)
is essentially a two stage process. ln the first stage Artemisinin is reduced to get Dihydro Artemisinin
(M.W 284).90.3% yield is claimed by the applicant in this stage. During second stage TMOA is used
to convert Dihydro Artemisinin into Artemether crude with 84.4 % reported yield. The crude end
product is subjected to purification and 91 .4 o/o yield is reported by the applicant. Considering the
percentage yields obtained at each stage by the company only 0.52 kg TMOA is the calculated
requirement for 1 kg Artemether. Furthermore, in all other applications from other companies not
more than 0.50 kg TMOA has been allowed.
4) The norms allowed for the export product were also based upon roughly same levels of yields
obtained in manufacture of Artemisnin. The DoP has considered 90% optimum yield in first stage,
850/o yield in second stage and 95% yield in the purification stage.
5) ln view of the above, there is no justification for upward revision of TMOA consumption norms
allowed against this application
6) This issues with the approval of competent authority
(Barnali Khastgir)
Phone: 23323292/Email : barn. khast@nic. in
(Shri Nirmal Kumar, Dy DGFT),
Email: nirmal.kumar65@nic. in
(
,
,
## Case No.B-3(Pa rt― ll
ViMAL DRUGS PRIVATE LIMITED
01/83/050ノ00351/AM13/DES―
lll
Adv.Lic.No 5う10o525o4dated 08.05.2012
RA File No.09/24/040/00049/AM13
epaltn]entofP|rat.nraceuticalsvidetheiroM
No. 350 ll1622/2012-pl(Nomrs) dated 21.04.2014, it was decided to revise tlte nornrs under Para 4'7 of
details
ve ri below or as
ied by the
Export ProdLrct
Export
Ouantity
S
,
N
Impofi ltem
Qt,:AI10"ё d
kゴkg
chOlic Acid
0
む
l
0×―Bile Paste(Solid COntant 75%+10%)
Cholic acid conteili 3 1%± 1%by HPLC
4.18
RA concerned may take further necessary ac!9n qs per above decisi.gn of NC.
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