DGFT Committee Minutes
Document text
Government of India Ministry ol' Contmerce and Industry Directorate General of Foreigri Trade Maulana Azacl Road, Nerv Delhi 1 l00l I Norrns Committee-lll Para 4.'7 Decision Meeting No. 09/g2l2017 of 2ot'7-18 clated 27.12.2017 (actually held on 05.01.2018) considered the cases/issues Lrnder Dufy Exemption Scheme (Chapter.4) of Foreign Trade Policy, 2015'20 pertaining to Chemical and Alliei products falling under Chapter 29 and 30, held under the Chairmanship of Shri J.v. Patil. Addl. DGFT in RoorI i-o.l l, Llclyog Bhawan, New Delhi. Following members were presettt:- ShriNirmal Kumar, Dy. Director Ceneral of Foreign Trade Shri Arun Kumar, Consultant, Departntent oi' Pharmaceuticals. The committee went through the minutes of earlier meeting No. 08/82 dated 13.12.2017 and approved the same. Note: In certuin cuses the clecision of the l{ortns Comnrittee re/ers to the Recommendations/ Observations / Deficiencies receiveel from the concerttecl Technical attihority in the same case or a dffirent case of another Jirm u,ith the sante procluc:t. A scannacl copy oJ' such document is placed at the end of the Minutes. ln sorne ca,ses, the sccmned copl'ttplootle'i n'i'y be unsigVed' n bollthes-e instances' the scannecl copy uploacletl is ro be crccepteci. ihe Crrnmitiee cloes not approve SCOMET items and all applic ants ar e un der s to od. MEETINC NUMBER :9182.LLC412017 MEETING DATE :27 .12'2017 'RLA File . :08 124 I 040 I 0047 8/AM I 4/ Lic.No/Date:081012903 I lDefer Date: 119.022014 IParty Nanlc:ヽ4EDl(ンヽヽ4EN IBIOTECH LTD, :RLA File t:05/24/040/00062/AM15/ ¨ 一 一 一 ８ ２ 一 ・ ４ 一 一 ０ ・‥ ２ ３ ２ ０ ‐ ７ 一 一 Ｎ ″ 一 一 い ‐ Ａ Ｌ ｃ ， ‐ 一 一 ‐ ， ‐ ３ ‐ ， ‐ ， ， ● ,Part)NanleiSCOTT‐ EDIL :ADVANCE RESEARCH ILAB AND EDUCAT10N ILTD I iCur. No.: l/9i 82-ALC4l20l1 li 1' tHq File i r:01/82/050/00728/AMl8/ I lDecision : Deferred Pirrty Nar,r':FINE CURE Meet No/Dite:9182- Status:Deferred IPHARMACEUTICAlンS LTD.:ALC4/2017 1 : l iCase No.:419/4/82‐ |ILC″ 2い7 1 1 P IHOlile ALC4/2017 127.122017 '-.-_.'l ,status: Deferred , | 霊躍I両慰 電開聴‐ =| I ;:01/82/050 t00421t AMtBt | IDecision:Dcfel・red
ξf証Ё iヽこ~~~「 Mcet｀o/Datc9/82‐ IES PVT LTD IALC4/2017 127.12.2017 1Lic.No/Date:0310792906 00847/AM15/ 114.01.2015 醜:5話お 3りAttj IDeclslon:Deferred RLA F‖ e :22/24/040/00041/AM15/ Palty Name:SHASUN PHARMACEUTICALS LIヽ41TED RLA File i04/24/040/00073/AM16/ f* la;;. No.z:e1 t 4 t82' auiq,doii lrilii ;s iHq nit. I i:0 I /82i050/00 I 05i AM I 8/ r_- lDecjsion'D:t.1"1 , 1離.器 IM381ヽ6'Daigiぅ万】I lstatus:Deferred :ALC4/2017 127.12.2017 Lた.ヽ。わ:ごbttE通遇 Fbtt「~ 15,06.2015 ” 一 ¨ 赫 一 ・ 劉 ‐ ５ 蜘 一 Ｅ Ｎ ｏ ・ ‥ ８ ４ ′ 瑯 ｉ ‐ ｅ 卿 一 ¨ 酪 ‐ Ａ Ｌ ｃ ｉ 陶 ‐ ‥ ｏ ‐ ／ ８ 満 ， 蘭 Ｉ Ａ Ｌ ｉ 欧 ― ‥ ｏ ‐ Ｆ Ｉ Ｉ し Ｐ Ｉ Ｉ Ｉ 山 ｍ ・ 恥 ヽ い 一 ¨ Party NamelTIDE INDUSTRIES ‐RLA File 134/24/040/00066/AM16/ Mcet No/Date:9/82‐ :ALC4/2017 127.12.2017 :Liciヽ6'DaEI万¨ 115.06.2015 Defer Date: .02.2018 二:■蕊癬面而可~~~ ,Aorm`::sed on the recornrnendation of D/o ffi;.;i,..,t"o.r. No.3501Ll774l2ot5-Pl(Norms) dated 5th Julv, 2oL6, uploaded at il;;;;;;;;r; ,,nr,., or as appried by the firm whichever is less under para 4.07 0f L lHgp vot.r. RA concerned may take necessary action as per declsio1 g,f Nc_ - :~1需需 221001鋼3「~~~ 三L二_ri lI II^r^ハ^ぃら nパぅ‖∩n∩fn′∩ lbtcision:Theと6rnrnittee declded to ratily norrns b:sと d on the recornrnendation Of D/ol lPharmaceuticals forwarded vide O.M・ No35011/75/2016-Pl(Norms)dated July′ 2016′ | lup10aded at the end of these minut,S° r as applied by the firm WhiChever is less underl ●1___^“ 」^^:´ :^ハAf｀lr l | |::|:・1.b;:lil卜V:i「1111P,C,IP'd rnaYl'ke necessa「)41Ct.° n_1ユper dec:sion of NC。__」 み
飛漱::1:酔濡二
::甍認需漸直~雷面而面
|
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丁he Cornrnittee decided to ca‖ forinformation based on the recomrnendation
1 lof D/o Pharmaceuticals forwarded vlde O.M.No35011/68/2016-PI(Norms)dated June′
: 12016′ uploaded atthe end ofthese minutes and deferred the case.
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.:41`'4/82-
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1 1
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RLA File
:07/24/040/00026/AM17/
:ξ漑戸理互開蕊:II
Party NallleiVERDANT LIFE
SCIENCES PVT LTD
RLA File
126/24/040/00006/AM17/
IMeet No/Date:9/82‐
:ALC4/2017
12712.2017
~‐
ILigi、3Б扇こ蕗Ibb要薄
l10062016
町
|
開
Party Nanlc:NATURAL AND
IESSENTIAL OILS PVT LTD
: _
―
IRLA File
l:07/24/040/00120/AM17/
Mもよヽレb話孫
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|
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芋郷
罐
胃
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d to r:1111A6rttsもatと8 6n the recornrnendation Of D/ol
lDecision:丁he COmmittee dC
:蹴 漱 鰍 鯖 P鍵 量嗜lAFTI爾 蝋 ltti冊 馴 | lunder para 4.07 of HBP Vol.l RA concerne . I INC, __ 」 IMeet No/Date:9/82‐ Ｆ Ｉ ICase No.:224/4/82- IALC4/2017 IParty Name10PTIMUS IDRUGS PRIVATE LIMITED :ALC4/2017 12712.2017 | IHQ File RLA F‖ e lts i:oilsztos0/00232/AMl8/ :09t24l040t0o391lAMlzl Palty Name:ORCH :LABORATORIESINDlA IPVT LTD IRLA Filc :09/24/040/00506/AⅣl171 Ⅲ虫t圭蝋責霊IⅢ濡濡霊瓢 | | IⅢl1101111三:'ⅢlⅢl主 | |lyUテぎ IIal蔦:[」:ふI蔦「 warded ude O.M.No35011/221/2016‐ PI(Norm→dated 2び hl : | . ^^´ _ 1 : :‐ ‐L^^」^``L^´ ^:ぃ11●^´ 、nバJ‐ fO rr●パ十ho rnくo l | ISeptember′ 2017′ up10aded atthe end ofthese mlnutes and deferred the case. 「砕癬輛が ~ I )「蛛|:鶯 | [警濡磁″~ 1171百六さ 11。 ILic No/Date10910064484 114.12.2016 11′ :Ц 9′l, |:01/82/050/00208/AM18/ 1Decision:Deferred Lic No/Datc:0910064446 07.12.2016 IMcet No/Date:9/82- lALC4/2017 12712.2017 Lic No/Date:0910064459 08122016 I I D;f., D"tt, ioz.oz.zot s I |卜」れ ,ヽ1品も :MマLAヽ‐~~ ILABORATORIES LIMITED IRLA File l:09/24/040/00473/AM17/ IMeet No/Datei9/82‐ IALC4/2017 127.12.2017 「… ,罷濡P″"~ 1 1 1810品 I l:ol/82/oso/oo2o7/AMl8/ lDecision : Deferred 1‐ 1食温:〃 82- 1lA, 1191幹|ユ, :01/82/050/00037/AM18/ lcase No.:173/4/82- IALC4/2017 bOI 鴨既5:/Om田ハ MⅣ IParty NameiOPTIMUS IDRUGS PRIVATE LIMITED IRLA Filc l:09/24/040/00512/AM17/ IMect No/Date:9/82- :ALC4/2017 12712.2017 ‐Lic No/Date:0910064489 20122016 Party Na:llc:ARVEE ILABORATORIESINDIA PRIVATE LIヽ41TED RLA Filc l:08/24/040/00H8/AM17/ Patty Nalne:OGENE ISYSTEMSINDlA LTD. IRLA F‖ e l109/24/040/00535/AM17/ IMcet No/Datei9/82- IALC4/2017 :27.122017 ILic NO/Date:0810139459 104.01.2017 Defer Date: 07.02.2018 IMectNo/Date:9/82‐ :ALC4/2017 127.122017 ILic.No/Date:0910064554 105.012017 107.02.2018 | L4
: IDeclslon:Deferred | IDecision:丁he Cornrnittee decided to ca‖ forinformation based on the recomrnendation i l=s:ζin(]::];i廿:』:l』:r:Il惜:nlllll・ A/1・ No35011/315/2017‐PI(Norms)dated 28th lese rninutes and deferred the case. | |~~ν ~・・・~― ′ ― ― ―・′ ~「
-prr. No.:230/4/82-
Parry Name:VIRCHOW f.Aiet f.f onut ";gl8L
iStrt*O.f.t*O
i
i, l,iicqtzoti
IPETRocHEMICAL PVT ',ALCqDon
i
I
i \
LrD.
127.12.2017
i
i
lr-le rit.
RLA File
Lic.Noi Date'oslo0oasoa
'P-d* l::: -
i
i221:01821050/00238/AMl8/ ':09t24l040loo262lAMrl1 r09.01.2017
\ol.oz.zott i
lrr'i',ri,irrct0/00238/AMl8/
l,oszqioqorca262tAMt-tt ')os 012017 _lfafary _
i
i lbecision : The Committee decided to call for information based on the recommendation i
:ri lof D/o pharmaceuticals forwarded vide O.M. No35011/3 L5/20t7-Pl(Norms) dated 28th i
pecembeち2017′ upbaded試市e end ofttese mmutts an,1,1,I:J_主r,.__二
1躍糖
1/4/82-
27.122017
27.122017 1
Lic.No/Dttci0910064568 1
|
満
ヽ約
礎面
直
陣
鰈
繭
奮
SCIENCES LIMITED IALC4′
IHQ File
RIンA File
Party Nanle:GLAND
PHARMA LIMITED
IRLA File
:09/24/040/00543/Aヽ417/
rf rv r rll
I l:011821050/00 I 5g/AM I 8/
':0912410401005371AM1'71
1,Pl??17……二_二J一ニユニ_…二
|
,ムblms t:ごとむ6ム11こ
~1さ
[Ь rnrnendation of D/o
35011/318/2017-PI(Norms)dated November′
les or as applied by the firm whichever is lesS
lDecision : The Committee decided to ratiiy norm based on the recommendation of D/o
,
'lllrLttrtr
uELrusu Lv I qLrrr-:'::
'-':^'-:",:::'^';;^-,^_:^,
,^.^,
I
ipharmaceuticals forwarded vide o.M. No3501U3t8/20t7-Pl(Norms) dated November,i
\ZOtl, uploaded at the end of these minutes or as applied by the firm whichever: lt::i
lunder para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision oti
INC.
ICase No.:166/4/82‐
IALC4/2017
?4 1HO ri18 ~
RLA File
:09/24/040/00527/ノヽⅣl1 7/
l:0 1 /82/0s0/00 I 74lAM I 8/
i iDecision : Deferred
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7
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1 __‐
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臨濡漱籠計
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控競雷
9/82‐~胃ふferredl‐
|
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IParty NameiSUVEN LIFE
ISCIENCES LIMITED
Meet No/Date:9/82-
ALC4/2017
ち
1針
"盤
ソ | |
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.Mcet No/Date:9/82‐
109.012017
107.02.2018 l
1r
istatus:Approved
.
i
iDecision : The Committee decided to ratify norms based on the recommendation of Dlo
lPh.r*...rticals forwarded vide O.M. No35011/3LB1IOL7-Pl(Norms) dated November,
i
..
. .
.
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27.12.2017
「昨癬動ニ
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27110「il`
|:01/82/050/00237/AM18/
IDecision:Deferred
「猥需漁
1'j″
82‐
281鴨島児
5υ001181↓11/
. IDeclslon:Deferred
IHQ Filc
l:01/82/050/00080/AM18/
lbιtiζ iott i beferred
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1:油:|:夕
4/82‐
='ti:e No.:184/4/82‐
1器3児5υ0023yAMIW
IRLA File
l:09/24/040/00559/AM17/
Party Name:VIRCHOW
iPETROCHEMICAL PVT
ILTD.
:RLA File
l:09/24/040/00542/AM17/
IParty NamclKOPRAN
IRESEARCH
ILABORATORIES LTD
IRLA File
l:03/94/040/00969/AM17/
eurty
Lic.No/Datei0910064575
12.01.2017
聴喩菅Ъ
講:要鸞rr―雪濤需而藤
ITECHNOLOGIES INDIA IALC4/2017
PRIVATE LIMITED
RLA F‖ e
t09/24/040/00513/AM17/
~|…
所82‐
IALC4/2017
127.12.2017
1孵¨
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l:09/24/040/00577/AM17/
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127.12.2017
f.i..No7out.os I 006a6 I 2
'7.01.2017
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IMeet No/Date:9/82‐
FStatus(ヽこ
Date:
Date:
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ト
ト
ALC4lzOll
Nanre:M.R.LABORATOARIES ALC4/2017
I
PVT LTD.
;27.12.2017
1鴨島
:5:/101:2/鳥lj l‰規
liυ0054″AMロ ーに
'NげData091006462■
131.012017
fer Date:
.02.2018
IDeclslon:Dcたrred
Palty NanleiMYLAN
ILABORATORIES LIMITED
一
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一
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Defer Date:
.02.2018
‐RLA File
:09/24/040/00574/AM17/
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.02.022017
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IParty NameiFDC LTD
IRLA Filc
:03/94/040/00991/AM17/
:ALC4/2017
.27.12.2017
ILic.No/Date:0310810972
106.02.2017
Ｆ
‐
‐
３
７
‐
‐
ILABORATORIES PRIVATE
.LIMITED
IRLA File
l:09/24/040/00536/AM17/
:ALC4/2017
IDeclslon:Deferred
18潰従胤ギυ″秘
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7
Status:Approved
|
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:09/24/040/00547/AM17/
:27.12.2017
ILi`:ヽ6′ bil`16うloo64659
Defer Date:
.02.2018
107.02.2017
IDeclslon:Deたrred
,ars｀attsA良ヽ人
~‐
|■w盛蔦助蕊I………
諄而悪温
b
Paty NameiSAKNA llVleCI NO/り
ι
lCHEMICALS PVT LTD IALC4/2017
1 12712.2017
12712.2017
1RLA Filc :Lic.No/Datei5210042169
1:52/24/040/00066/AM17/ 10702.2017
39爵島
:::1:ふ/1↓t
鳥;″漉鮮戸獅而而開
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上
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|:``｀ま:440'4'恵2‐
IALC4/2017
btclslon:Deたrred
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‐‐
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０
‐
‐
Paiy Name:ZYTEX
.BIOTECH PVT LTD
IRLA Filc
l:03/95/040/00855/AM17/
IMcet No/Datei9/82‐
Deferred
IALC4/2017
127.122017
ILic.No/Date:0310811026
Defer Date:
108.02.2017
.02.2018
IMeet No/Date:9/82‐
IALC4/2017
127.12.2017
IMcet No/Date:9/82‐
IALC4/2017
127.12.2017
|:おNiふさ:JticHEMICALS
&PHARMACEUTICALS
]LIMITED
,RLA File
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:03 I 9 4 I 040 I 0l 005/AM I 7/
ILitiヽ6751:3bj1681H43
113.02.2017
: Deferred
「
~ド黒｀出蒟り
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■Ⅲ,ⅢlIPヤ「
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,Palty NannelGLOBAL
ICALCIUM PRIVATE
iLIMITED,
: ‐ ‐ ｀^~~~
lRLA File
IMeet NO/Datei9/82‐
:ALC4/2017
,7.12.2017
ii..No/Dut.'07 101 1 I I 32
:07/24/040/00368/AM17/
lm酔ド』
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8::`8'4'8'1
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|
14颯従ガ∬
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1502.2017
|
1腔驚
1軍:t蝋農
!:IW‖11‖II"11菫精萱
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il赴鮮榊II憶1砕彗:黎誰蔓
I讐Lttl額畢
|
I lilll;;:',"ffi; il ;;;;;l ;' ;;;;".erned may take necessarv action as per decision orl
i
|INC,________
IPVT.LTD
127.12.2017
iRLe Pite
l.:03 I 9 5 t 0 40 I 003 6 | I AMI 7 I
Party Na:ne:VINS
iB10PRODUCTS LTD｀
127.12.2017
IRLA Filc
i:09/24/040/00622/AM17/
:Lic No/Date:0910064689
116.02.2017
Ｆ
‐
‐
４
６
‐
‐
iCase No.:143/4/82-
ぃ
LC″2m7
1器晶児
5υ00“ ν
AMIW
IDeふまbi16:ふ|::
IPatt NameiMICRO LABS
ILTD
IRLA File
107/24/040/00375/AM17/
Mect No/Datci9/82‐
ALC4/2017
127.12.2017
ILic.No/Date:0710H l158
121.02.2017
:Party Name:PANACEA
IBIOTEC LTD,
,RLA File
l:05/24/040/00551/AM17/
IMcet No/Date :9/82‐
IALC4/2017
127.122017
1Lic.No/Date:0510401730
,1.02.2017
iStatus:1)eferredl
8鵬既11:07vttyw
IDecls10n:Deferred
ICasc No.:63/4/82‐
FК
ttm7
IPany Namc:ALTA
ILABORATORIES LTD
tRLA File
|:03/94/040/00998/AM 17/
IParty Namc:ALTA
ILABORATORIES LTD
IRLA File
103/94/040/00997/AM17/
PHARMA PRIVATE
LIMITED
'Meet No/Date:9/82‐
IALC4/2017
12712.2017
‐
´
―
一
―
一
―
一
―
危
π
下
落
雇
落
再
両
面
両
丁
面
百
面
Date:
.02.2018
iCase No.:l8lt4182-
ittcqnoYt
27122017
囁脱鳳島
IⅢ
RLA Filc
i:09/24/040/00561/AM17/
沈飛ぶ嚇畷
f
ALC4/2017
.27.12.2017
:Liしヽ3/bai3ibjloを11363
ILiC NO/υ at
122.02.2017
IDecls10n:Deferr,1
FDe cision : Deferred
Ｆ
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Ｌ
Ｆ
１
１
・
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一
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一
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o::`4'4/なが
I l:01/82/050/00072/AM
I u'
i
r-
, lDecisiofl i Deferred
Date:
Date:
Date:
た1`eヽも
.:fζ3/4た21 ~
ド乾鰤
FHQ Fれさ‐ ~~~
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Party Name:OGENE
iSYSTEMSINDIA LTD.
Meet No/Date:9/82‐
IALC4/2017
127.12.2017
lLic.No/Date:0910064722
124.02.2017
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IALC4/2017
127.12.2017
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IPRIVATE LIMITED
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l:03/94/040/01078/AM17/
IPRIVATE LIMITED
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ALC4/2017
127.122017
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127.12.2017
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02.03.2017
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1 1ALC4/2017
IPa“y Namc:SUVEN LIFE IMectNo/Date:9/82‐
ISCIENCES LIMITED
IRLA Filc
l:09/24/040/00634/AM17/
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103.03.2017
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IMEDICINES LTD,
IRLA File
134/24/040/00322/AM17/
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i27.12.2017
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108/24/040/00508/AM17/
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127.122017
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IRLA File
i:34/24/040/00355/AM17/
IMect No/Date:9/82‐
IALC4/2017
127.12.2017
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12003.2017
Defer Date:
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IRLA File
l:03/95/040/00995/AM17/
IMeet No/Date:9/82-
IALC4/2017
127.12.2017
‐Lic No/Date10310812040
12303.2017
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IALC4/2017
127.12.2017
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124.03.2017
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IMcet No/Date:9/82-
lALC4/2017
127.12.2017
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12503.2017
1岬
: The Committee decided to ratify norms based on the recommendation of Dlo
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129032017
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122/24/040/00114/AM17/ 130.03.2017
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Patty Name:MAHIMA LIFE
iSCIENCES PVT LTD.
IRLA File
i:05/24/040/00636/AM17/
,Meet No/Date:9/82‐
ILic.No/Datc:0510402098
130.03.2017
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127122017
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IALC4/2017
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B10TEC PVT LTD
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RLA File
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107.02.2018
07.02.2018
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IALC4/2017
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110.04.2017
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127.12.2017
ILic.No/Date:0910064902
111.04.2017
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PHARMA LIMITED
IRLA File
109/24/040/00665/AM17/
Decision : Deferred
## Case No.:215/4/82-
ALC4/2017
lo91:Ii′
:
ase No.:257/4/82-
LC4/2017
IDecision : The Committee decided to Call fOr information based On the
irecOmmendation of D/o Pharmaceutlcals forwarded vide O.M.No35011/347/2017-
‐
IPl(Norms)dated December′
2017′ uploaded at the end ofthese mlnutes and deferred
l Ⅲhe Case. ____ __一
――
一
ト
開脇:扁戸臨誌
OЮttAM71
~~FCiζ
`｀
も
:::力
'4/82‐
ぃ
Lα2創7
Hl鴨既51ili:Я↓
lj
| |ヽハバ。inn.nρ fprred
Party NameiCADILA
IHEALTHCARE LTD
IMcet No/Date:9/82‐
IALC4/2017
,7.12.2017
IALC4/2017
127.122017
Partv Nalllc:MATRIX FINE
SCIENCES PVT.LTD.,
rDecision : Deferred
~ :Paお
N:品
`IЁ
16L6ё lёAL E
ILTD
IRLA File
109/24/040/00676/AM17/
1面3J赫
7恵2‐
ALC4/2017
27122017
臨需繭而開霜
,Decision i Deferred
l ibeclslon:Deferred
RLA File
|:04/24/040/00004/AM18/ 13.04.2017
:DRUGS LTD
RLA Filc
Lic No/Date:0310812404
糧罷璃il沖
3'4/b'」
,iu.tv Nur*ceil-rN PoiNT
- mf'*tD"fttt-d
't-eeonnroRlEs LTD., 'iALC4allz
I
2'7.12.2017
i
「
證籠が
'∫
″υ″
82
‖
3hQ品_
14
Date:
il l.04.2017
Date:
f ,O tigZ,OSOlO0348/AM I 8/
:09/24/040/00694/AM17/
13.04.2017
tDecision : The Committee decided to call for information b.;;d ;*
th"
irecommendation of D/o Pharmaceuticals forwarded vide O.M. No35011/338/20t7-
lRt(trtorms) dated November, 20L7, uploaded at the end of these minutes and deferred
Ithe case.
Pary NameiGRANULES
INDIA LIMITED
iRLA File
i09/24/040/00017/AM18/
Meet No/Date:9/82‐
IALC4/2017
127.12.2017
ぼδ
ttα醐∞“剣
1
跳λ帖0創囲Att ν
悧
鰊
510812492開
蕊
丁
i - [Cur" No.:298i4l82- Parry Name:MOREPEN fuf..t NoZOul.S/82- lstatus:Approved
t, ll*tcttzott
:LReoRnroRIES LTD., ALC4l2olz
i
i
27.12.20t7
|
lotDate:0j 1o4o22nl
i
ho nit.
RLA File
,Lic.)
:
:HQ nit.
RLA File
Lic.No/Date:0510402238 i
I
l,ouazto50/00306/AMl8/ :05i24/040r00004/AMI8/ 18.04.2017
I
Il
ll16lbecision : Ths committee decided io iriiti-no.mib;;;;th. *."rr"^drt'r, "f
liI iOlo pharmaceuticals forwarded vide O.M. No35011/14/2Ot7-Pl(Norms) dated 27th
; lS.pt.rber,2017, uploaded at the end of these minutes or as applied by the firm
i
lwhichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary
tl
iaction as per decision of NC.
|ドⅧ
/1蠍》
l iCase No.:211/4/82‐
1 1ALC4/2017
11。
|
ParりName:OM
IINTERCONTINENTAL
IRLA File
i03/95/040/00025/AM18/
'Mect No/Date:9/82‐
lt 18 i,
I
iHq rite
Party Nanlc:RECKITT
BENCKISER
HEALTHCARE INDIA
PRIVATE LIMITED
IRLA File
:05/24/040/000171AM 18/
Palty Name:RESONANCE
IMcetNo/Dtte:9/82‐
1..ハ
´ ′^^,_
iALC4t2otT
l,zl.lz.zotl
101/82/050/00219/AM18/
IDeclslon:Deferred
Defer Date:
.02.2018
:l l9 iCase No.:25614182-
I
″
.02.2018
ICase No。:259/4/82‐
lALC4/2017
|
Date:
H5隔
,屋:510虚島
/1話」
Decision : Deferred
Date:
I亜ヽルう繭ぴ~F画面而
|
「ミ
Lё 4'ibl'
I
IHQ File
l:O1/82/050/00264/AM18/
SPECIALTIES LTD
IALC4/2017
127.12.2017
,nLe piie
----Ei"N"/D"tro3t0812525
:03/95/040/00s25lAMl7l 18.04.2017
Defer Date:
7.02.2018
一
‐
２
０
ICase No.:218/4/82‐
FLα
2側7
Party Name:DHANUKA IMeet No/Date:9/82‐
ILABORATONESLTD i針
け鰍了
|~~´ lё ase No.:265/4/82-
| IALC4/2017
: |
12111,11111'I1111ti
,
,Decision : Deferred
Palty Name:DELTA
FINOCHEM PVT.LTD.
IRLA File
103/94/040/010817AM17/
IALC4/2017
,7.12.2017
lLici｀315面百覆百百面百蕎百
,104.2017
「
~~|む
:ζざ漁
`::335'4′
な
2‐
|ILC4/2017
122 1HO lil`~
1:01/82/050/00347/AM18/
Party Name:NIFTY LABS
PVT LTD.,
RLA F‖ e
109/24/040/00695/AM17/
ぶぶ」認も
5う10064935酵覇
.辮:
~Ψ罐
:Decision : Deferred
| lcase No。:263/4/82-
| IALC4/2017
1 1
123"ュぃ夕
:,71111
上
_P'11,'1:P,T「「リ
「
~積
饒濡″″″秘
」__二 _
‐
―一
1125,従や
躙γ
1821
IParty Name:DELTA
FINOCHEM PVT.LTD.
RLA File
:03 I 94 I 040 I 0 1080/AM I 7/
Party Name:DELTA
FINOCHEM PVT.LTD.
RLA File
:03 1941040101082/AM I 7/
"轟'Naniよ
責Ё
fttσ LA百ゞ
ILIMITED
IStatus:Approv`d
IRLA File
:Lic No/Date:0510402259
119.04.2017
|
fnq rir.
1器疏
5餅0022αAMIν
鵬筋
liOЮ063VAM17 1
iDecision : The Committee decided to ratify norms based on the recommendation of
iO/o ,tl.rrnaceuticals forwarded vide O.M. No3501U03l2}L2-Pl(Norms) dated 6th June,
|:blJ′ 」p10aded at the end of these mlnutes or as applied by the firm WhiCheveris less
lunder para 4.07 of HBP Vol・1. RA concerned may take necessary actiOn as per decislon
lof NC. ________―
―一一
Defer Date:
107.02.2018
′|
1
Decision : Deferred
ALC4l20l't
2'7.12.201',7
Ｆ
Ｉ
Ｉ
「鵬既5υ0035υAM剛
IDecision:Deferred
は従淵″
y″
"‐
IHQ File
l:01/82/050/00351/AM18/
「Declslon:Deたrred
~lbase No.:397/4/82‐
lALC4ノ2017
|
| IDecls10n:Deferred
RLA File
■09/24/040/00681/ノヽNl1 7/
iF;'ty N ;*.'. HETERo iABS
Ittutrpo
i
27 122017
I Lic.No/Date:09 I 006495 I
'24.04.2017
一
睡
1往(織赫
124.04.2017
126
IRLA File
109/24/040/00038/AM18/
~~1需聴
3・5｀δ
ttLA「断熟
rαり
"‐~
Ｆ
Ｌ
Ｆ
Ｉ
寺鯖卿醐
4
Ъ 舗
l:υ0003繁Mlツ :プ
成り滞
‐υフiVVVπ ノ′‐
|「務.五百
曖鷺ヽ彙
1漑峰癬
Attζ~Y:蒻
:夕秘
い
詩スキE ЫMrED I針
"猫
v
IЪち昴
::υ0069りAM17
:Liどi面ふ′う五
iじ
…
IParりN:heib16L6ё iこAtt Ё
ILTD
'4.04.2017
BO鵬
L鬼5υ0040yAM W
|‰ち昴
liOЮ020gAM17
1誡漱:幣悦
｀面馬面:り"丁陣m∬映たrd
IALC4/2017
'7.122017
Defer Datel
07.02.2018
Status:APProved
静
玉ヽ
li霊ガ
::iVililili
′井
|
.Decision : Deferred
IDecls10n:Deferred ____
FHQ由お
|:01/82/050/00381/AM18/
IRLA File
:03/94/040/00025/AM18/
IDeclslon:Deferred
ICase No.:70/9/82‐ ALC4/2017 Palty Name:MYLAN
ILABORATORIES LIMITED
'Meet No/Date:9/82-
IALC4/2017
12712.2017
臨既::/::197AMⅣ
IDecision:Deferred
|
~~ IRLA Filc ~~lliざ
:ヽもた面肩両面両面蒟扇
“
:09/24/040/00009/AM18/ 125.04.2017
冊
一
‐
３
３
【
biζしヽ
8:ibウカ
4′患
'_
IALC4/2017
Pa●y Name:GUJARAT
ORGANICS LIMITED
RLA File
103/94/040/00087/AM18/
red
lcaζ
`ヽ
も
::ζ g'う
'bう
:Atё4/2biヴ
|
|
1需
ふ品轟i乱6dモAL百~IWλ
ν
RLA Fne
:09/24/040/00207/AM17/
り7.12.2017
ILiしヽo7Dtteb51b064972
う,n/4うn17
27.04.2017
冊
B4田串
|1錠♀
71省Ylγ
Ｆ
Ｌ
Ｆ
Ｉ
|ん
J
,Decision : Deferred
監:棚ッαり
82
り7.12.2017
i Li..No/Dui"o3 I 08 I 29'
‐27.04.2017
iDecision : Deferred
´
´~1 ~‐
´
~~
Date:
.02.2018
-,qa: No.'.raoarazt ii?I6ffili;";;;;r, \Syiiiiot; I
lnt cllzotz
l'lNuLnr'rvr I v r 'L I v'
\zl .tz.zotl
1_
i
'r-i..Nolout* o3loSt2g1.I-Ff- Date:
t37'"0 0,,.
RLA File
- ;;;;;; --
loz.oz.zota
l:01/82/050r00388/AMl8/'ol)q+loooloo030/AM18/':2:7\
:Decision : Deferred
rParg Name:INCHEM
ILic.No/Date:0310812788
25.04.2017
ILic.No/Date:0310812840
126.04.2017
G:二::Ali ttA ■Mee:N`/Dateつ/82‐
「
~~ l r~赫
面画面
1協.器_
1鴨既
50103171↓ij'Iヽλ
tti11:虚:1↓lj~野翠
睡
: NO.:332/4/82‐
ル
IMeCt No/Dat¨
師
u∬ApproVed
Date:
.02.2018
lcase No.:305/4/82-
IALC4/2017
鵬肌5υ003BAMlν
IDecls10n:Detrred
Ｆ
‐
―
―
‐
―
‐
―
Ｉ
Ｌ
't Noloate"s/82- -- -1Sta6""ennt*to
i
f*-iCrr. No.:77l9/82- iP"ttvY*::VEGESNA lMee
i i
r.r"lurt*oeroG+ezt[
i
I iro r,,.
*iRLA Fii;
l,-ic'
i
:01/82/050/00804/AMl8/ 'OS":q'O4O"OO045/AMl8/
2"1'04'2017
]--o^^^r'-n ;il
lo1/82/050/00804/AM18/ :Uソ∠
41U,υ′υ
Yυ 'ソ′ハ
1
140ilili:il:111‖II∫::ll!:lil
貯ザ
I写IWツキ
1鴨既
5υ0021θAMlν 胤ち刷
:OЮ003α測
139bttision:The Committee declded tO ra・
鳳服TT獅Fl:|::脳:電:1週d:nF_____…
…い
noressaⅣ
i ll,iiilll::'; '";; ;il:;;;,.; +oz ot HBp Vor l RA concerned mav take necessarvi
.- * * -*--*\
i
laction as Per decision of NC'
ili::H::,3lll; ffi'.1Til'ori "i
HBp Vor l RA concerned mav take necessary
action as Per decision of NC'
Patty NameiCADlLA
HEALTHCARE LTD
IRLA File
l:08/24/040/00016/AM18/
IParty NameiSTYRAX
IPHARMA PRIVATE
ILIMITED
‐RLA File
l:o9/24/040/00032/AM18/
__1 ___
― ~~´
~~~
'---
fiiai.i NorPute.9t82'
Party Name:AE´「HER
′々
ALC4/2017
27.122017
'8.04.2017
⌒
:ALC4/2017
12712.2017
‐case No.:40/9/82-ALC4/2017
142
;_
ii+: Cut. No'1205/4/82
|“1ヽ
"理
亜In虹墜型
ハ
‐
ALC4/2017
IHQ File
i:01/82/050/00213/AM18/
INDUSTRIES LIMITED
IRLA File
:52/24/040/00004/AM18/
「
LC4/2017
127.12.2017
おドバ辮α
"Ю餌
"“ 1沸.器
Decision : Deferred
ICase No.:331/4/82‐
lALC4/2017
Pany Name:AUROBINDO
PHARMA LIMITED
IRLA File
l:09/24/040/00044/AM18/
IMcet No/Date:9/82‐
IALC4/2017
127.12.2017
1:「バリ
:キ彎
eib。10064988
ICase No.:221/4/82‐
lALC4/2017
1
145障011i3
‐~
:01/82/050/00229/AM18/
Party Name:BAROQUE
|卜責XttM天こЁuTIcALS PVT.、ALC4/2017
ILTD
ヽAしし・
|′ ιVII
,7.12.2017
|
IRLA F‖ e
l:08/24/040/00536/AM17/
ILic.No/Date:0810140185
.01.05.2017
:Declslon:Deferred
IMeetNo/Date:9/82‐
IALC4/2017
127.12.2017
lHe rite
i :0 I /82/050/00 I 50/AM I 8/
jDecision : Deferred
IRLA Filc
131/83/040/00010/AM18/
itf.N "/D-"trl
I I 00667 I 2
lor.os.zotz
貯辮滋II聯『響TM
1器島児5υ00269AMlν 胤ち墨:09997摯Vlγ
0105.2017
,Case No.:l4ll4182'
ALC4l20t1
;Pamy Name:CLEAN
SCIENCE AND
TECHNOLOGY PVT,LTD.
RLA File
:3 I /83/040/00012/AM l8/
IDeclslon:Deferred
一
|…焼卜藪ク
Datc0310812954
冊
昨璃鷲
2/4/82‐ ~~1繁
鐵1筆D
′ダ
Date:
.02.2018
Ｆ
Ｌ
ド
ー
Decision
IMeet No/Date:9/82‐
IALC4/2017
繭
Date:
鵬肌
5υOm4りAYw
ハ
Ｆ
Ｌ
ド
ー
t*_
jCase No.:31914182-
:ALC4l20t7
L
i-rHQ File
| :0 I /82/050/0 0327 I AMt 8l
I
iDecision : Deferred
降,li諄
5/4/82‐
~
lhOFiie
l:O1/82/050/00353/AM18/
Palty Name:HETERO LABS
ILIMITED
IPany Name:HETERO LABS
iLIMITED
|
IMeet No/Date:9/82‐
IALC4/2017
1 _ ____
:Deferred
127.12.2017
~lRLλ
T籠~~~~~~謄
ご喘離
0%0065001
::09/24/040/00069/AM18/
謗‖"
Decision : The Committee decided
Dlo Pharmaceuticals forwarded
iNovember , 20L7, uPloaded at the
whichever is less under Para 4'07
action as per decision of NC.
:Lic.No/Date:0910065002
10305.2017
to ratify norms based on the recornrnendation of
vide O.M.No35011/199/2017-PI(Norms)dated
end of these rnlnutes or aS applied by the f:rrn
of HBP VOI,1. RA concerned may take neceSSary
IRLA File
109/24/040/00066/AM18/
|む基
`No.:206/4/82‐
IALC4/2017
IParty Namc:MOREPEN
ILABORATORIES LTD,
IRLA File
l:05/24/040/00041/AM18/
:01/82/050/00214/AM18/
IDeclslon: Deferred
「
~~Ⅲユ
N∝9ρβ
ttALC″獅7
|
152 110 1il`
m柵∬計)MrED
IRLA Flle
109/24/040/00030/AM18/
||五rty｀:語ざ
:ヤiMAL 5良jё∫
¨
PRIVATE LIMITED
‐RLA Fllc
l:09/24/040/00060/AM18/
Patty Name:AUROBINDO
PHARMA LlMITED
:RLA Fne
l:09/24/040/00021/AM18/
IMcet No/Date:9/82‐
IALC4/2017
127.12.2017
ferred
Status:Approved
1瓦こ42017
27.12.2017
1Li3:ヽも
'bま
ま赫
1而TNnnate:9/82‐ lStatus:
'ALC4/2017
27.122017
Lic.No/Datei0910065004
103.052017
′ ι
冊
|むistヽ6::75'0'8'LALC4''bi7
“
4鶴鳥虚月上
/:0:ijl話j~
,Decision : Deferred
1581青O Filc
101/82/050/00763/AM18/
1Declslon:Deferred
IPaty Name:HIKAL
ILIMITED
IRLA File
103/94/040/00078/AM18/
~Mも
81ヽル滉L断面
「
~
:ALC4/2017
127.12.2017
~肝
]『]R
ICase No.:378/4/82‐
IALC4/2017
iCase No.:212/4/82‐
い
LC″2側7
1571白O Filc
IRLA File
105/24/040/00024/AM18/
Lic.No/Date:0510402447
04.05.2017
Parry Name:SIMPEX
1面語
…
PHARMA PVT LTD.
IALC4/2017
127.12.2017
|:01/82/050/00220/AM 18/
IDeclslon:Deferred
たise No。:36/9/82‐ ALC4/2017
Party Name:SRIAM LABS
PRIVATE LIヽ41TED
‐RLA Filc
109/24/040/00062/AM18/
Parry Name:NATURAL &
igssENtteL otLs
PVT.LTD..
tRLA File
| :07 12410401000 I 2/AM I 8/
幅
赫
1夕82‐
:ALC4/2017
127.12.2017
ILic No/Date:0910065006
104.05.2017
1躙.器
「「饒濡
P″秘
Defer Date:
|
が響、だ聡 IW呻潔曽師蔑‐~肝薦
・
lpЮКd
lё ase No。:355/4/82‐ IPalt
WiI.… 1■llt群…
|
[i,iJ[ro,o.36i/AMl8/'oJi:r'o+o''.'0027/AMl8/
0e'05'2017
l6l ibecision : The committee decided to ratify norms based on the recommendation of
,o/o pharmaceuticals forwarded vide o.M. No3501U3 39l2oL7-Pl(Norms) dated
iNovember,z1t;, uploaded at the end of these minutes or as applied by the firm
lwhicheverislessunderpara4.oTofHBPVol.l.RAconcernedmaytakenecessary
action as Per decision of NC'
i162にase NQ:ζ ´
"||IⅢ
ⅢⅢウ|'a,yN,T∝今U｀9P甲P9
′み
l
亜激ド
|
Ｆ
Ｌ
ド
ー
一
Ｍ
一
Ａ
．
６
０
０
０
・
‐
ｅ
Ю
一
Ｆ
ｉ
８
２
Ｈ
Ｑ
側
IDecision: Del'erred
IALC4/2017
127.12.2017
ti`:ヽ。
baiもib'10H1546
105.05.2017
Date:
.02.2018
Ｆ
ほ
ド
ト
IDecisiOn:Deferred Deたrred
HQ File
101/82/050/00768/AM18/
Date:
「~ ~
1
110 1ile
l:01/82/050/00783/AM18/
1Dおこ
igi`I:5t穐:|:`
Deferred
1 lOecisior i Deferred
IPHARMA LIMITED
IRLA Filc
|:09/24/040/00086/AM18/
Party Name:BIOLOGICAL E
ILTD
IRLA File
l:09/24/040/00349/AM15/
～~~~~IALC42017
IALC4/2017
127.12.2017
町
1脇.尉:
,r-,;;;;;
r ;;. committ.. decided to ratifv norms based on the recommendation of
:Dlo Pharmaceuticals forwarded vide o'M' No350,U3'^Ll1?']:ii,*"fltlr"ollr"i
1特:lettllilll:る1りllI15。」
:L:::11le Li: 。
i these nlinutes Or as applied by the firrn
i、vhlchever iS leSS under para 4.07 of HBP VOI.1. RA cOncerned may take neceSSary
い
面
On,SPγ
,,'J919「
N'・
―
一
一
一
―
一
―
一
一
一
~一
―
[- fCur. No. : +ai9/82- i:t'cs tzot'l iPartv-\ 1me
: G LAN D
I l"'"'
iPuenl',te LIMITED
ll
I iffid;s0/0077s/AM*r8/
\:oltvvoqor000051AMl8l
I
I-"..---^h-r^-.-^i
~lM`81No/Date:9/82‐
tus:
:ALC4/2017
,7.12.2017
Deferred
~~~Iti`下豪75面語雨う10065025
Defer Datel
IHЮ ,2∝7
.02.2018
iCare N o., I t 4 t82- ALc4 t2ot1 |?#,+$,.,
t EE PHARMA
―
一
一
一
―
一
一
RLA Fiiざ
~…
Ю9/AM18/ 1109/24/040/00084/AM18/
Status:APProved
「
P品
品動二乱赫
響
譜麻濡
鷺
獅霧停"~F“
proved
| 1鶏鵬議詰…FttTT=!=喜:4
輛胤鳳
:蔦話:~端 _
:101/bZ/UDU/Uυ υll′ ″｀
lVl 1 0′ 0´ '~‐ ~ ~
165 1btciζ iふI:The commttteさ
ふecided tO ratifv normS basとa gFIhe recOmmendation Of
lD/o PharmaceuticalS fOrwarded Vlde O.M.No35011/206/2016-PI(Norms)dated
lseptember′ 2016′ uploaded at the end Of these rninuteS Or as applied by the firm
iwhichever lS less under para 4.07 of HBP VOI。
1. RA cOncerned may take neceSSary
籠i語Ls rr,9,'P,ずN'
一――
メ
:Lic.No/Date:0910065017
1l105.2017
Date:
.02.2018
izl.tz.zotl
10∝おおn:Dttrd
iCase No.:430/4/82-
IALC4/2017
1
“
8鶴
3島鷺話話jl詰j
Decision : Deferred
ICase No.:411/4/82¨
IALC4/2017
Party Nanle:PRASOL
ICHEMICALS LIMITED
IRLA File
103/95/040/00063/AM18/
Mcet No/Date:9/82‐
1針
"鰍
了
Lic.No/Date10310813187
1l105.2017
IParty Name:TRANSPEK
INDUSTRY LIMITED
IRLA File
l:34/24/040/00032/AM18/
IALC4/2017
,7.12.2017
1Lici｀冠圧通
I」3410043170
111.05.2017
1691百0「il`
|:O1/82/050/00419/AM18/
I Ca:き｀も
lё4肋患二ALC4/26脅絶よ濡壺語雲儒XA~澪雷潔漑
PRIVATE LIMITED
IRLA Filc
l・00/,4ノ04
|:09/24/040/00063ィ
^vl1/
lofNC.
M8&｀o/Dtte'/82‐
IALC4/2017
12712.2017
-む3
icur" No.,aJ,tstgi-iLiqlzifi Paftv Name:ARENE LIFE
I
:SCIENCES LIMITED.
1器肌5υ0081υAM lν
RLA File
109/24/040/00050/AM18/
IDecls10n:Deferred
11205.2017
|
―~~●■ (「
:jl■く
1lfヽ31メミ
~IMユ
|‐ No′5江eう/821~~面atu::Approved
冊
お
:LヽAibttjdも IMもも
tNo/Date:9/82¨ |
IALC4/2017
り ,7.12.2017
tはヽル
b表86…
へ′
AAξ つく′人ヽ■17ア 1つ
0｀2017
「′
1鸞ITI事ⅢⅢ
革禦‖
TttI年ギ
I
I.2017 1
ased On the reCOrnrnendatiOn
07.02.2018
f-bur" No.:66/e/82- :pu.ty Name:ARENE LIFE Y,"1X"]P3t "tsts2:- ist't"tAeet'*d i
1 Fttr,;;lw
' o3-
bci'eNc's LIMTTED l,|i?i::rtl _l_
I
l!
i'*------------'---r
I
I
-'--.-..
--
-
^^r^^ztn,
1l
I tuo File--
-{[in piie
iu"N;ril;oerooosolt I
I l:or)szros0/007e3/AMl8/
t',0:s,ziioiorc0026/AMl8/ l,r.or.'ol'
l^r^;;:;
^;
i,r, i;;;;;,
, in" committee decided to ratifv norms based on the recommendation of
1 iD/o Pharmaceuticals forwarded vide o.M. No35 OtLl48Ol2014-Pl(Norms) dated March',
I
izors, uploaded at the end of these mtnutes or as applied by the firm whichever is less
i
iunder para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision
′7
Date:
ハ
', Dlo Pharmaceuticals forwarded
llI
lruovember, 2O!7, uploaded at the
1 *tli.tl.ver is less under para 4.07
I
taction as per decision of NC'
vide O,Mo No35011/225/2017‐ PI(Norms)dated
end of these nllnutes or as applied by the firm
of HBP Vol.1. RA concerned may take necessary
Pary Name:EYTAN LABS
LIMITED
:ALC4/2017
12712.2017
町
Defer Date:
.02.2018
IRLA File
109/24/040/00034/AM18/
口
5鴨島
:::力:::il↓t
‐RLA Filc
:09/24/040/00076/AM18/
IPatty Name:HETERO DRUGS
ILIMITED
IMect No/Date:9/82‐
:ALC4/2017
127.12.2017
ILic.Noわ江e:0910065043
115.05.2017
Date:
.02.2018
IDecision:Deferred
IRLA Filc
109/24/040/00075/AM18/
icase NQ38/9/82-ALC4/2017 1alt挙
8牌欝∬
よ金)、41TED
錦ユト
1品た
1立上躍卵γ岬
`型
w
IALC4/2017
.2712.2017
I
Decision : Deferred
Pa●y Nanle:DHANUKA
:LABORATORIES LTD
|
Lic,No/Date:0910065035
112.05.2017
1
|
|口
6鵬諺
::::::;'1↓lj~
冊
‐
Status:APProved
1
## Case No.:58/9/82- ALC4l20l1
卜
410品
I
l:011s2/0s0/00785/AMl8/
| 「
~…… ~ ~~‐
LDecision : Deferred
「F黒｀
も
°
お
4/9/§が
ALё 4厖赫
iStatus:
iDeferred
l
I
Party Name:HETERO DRUGS
LIMITED
Mcct No/Date:9/82-
IALC4/2017
127.12.2017
ｄ
Ｓ
ｔ
ａ
ｔ
ｕ
ｓ
‥
¨
loefer Date: I
lor.oz.zota
1
ILic.No/1Date10910065042
115.05.2017
Pany NanleiVIRCHOW
.BIOTECH PV T L´「D,
IⅣIeet No/Date:9/82-
IALC4/2017
127.12.2017
| lof NC.
購
;颯食漱″ン″移
⌒
ⅢⅢ麟J需 1癬漱酉幕~画面而面
|
iCase No.:407/4/82‐ Part)
1 _ _ _^´
_ 1■
■n
卜
LC4/2017 :ABORATONESLTD i分
散獄v l
i* o,*
"-inn *-
. .--- iLi"N"/D"ttos10402586
,oitszloso/gg415/AM t 8/
:05123t040100026iAM 18/ t6.05.2017
i
rtO pecisioo i if,. Committee decided to ritify norms based on the recommendation of
io/o pf,.r*aceuticals forwarded vide o.M. No3501U327120L7'Pl(Norms) dated January,
]zora, uploaded at-,h:-..".d { tl:se '"li:::t,i::.T,.']'::.::.t:: Ti;:::::TJ:,[';
|こV↓υ′ ur=VЧ ― ‐― ―‐ ‐… ~~ ~
lunder para 4.07 of HBP VOI.1. RA concerned may take necessary actiOn as per decision
lcase No.:395/4/82-
IALC4/2017
1
lof NC.
lHQ Pite
i:01 /82/050/00403/AM I 8/
-*
learty Nam.loons r'iPorrt,t
IPVT.LTD.,
I
I
iRle n'ite
l:05 t23 I 040 I 000s I /AM I 8/
IMもも
1ヽo/bate,/82‐ |
1針撃螢7
11aO,2017 _
「
~に
1:も｀ま:465/4/82‐
| IDecision:Deferr,d
Party NameiSTERMONE
iCHEMICALS PVT LTD
IRLA Fllc
li34/24/040/00282/AM17/
:漱蕊1:餅Ж
`ξ
k
LTD.,
‐RLA File
103/94/040/00149/AM18/
IMeet No/Datei9/82‐
IALC4/2017
127.12.2017
に再ヽ35冨粟画面高再頂万
1605.2017
Parry Name:AARTI DRUGS Y.t1x"/Date9182'
ir-ir,,rrreo
t!!9:t?:.1:
127 '12'2017
I
'-*-------^:'==;
RLA Filg一
~~ ~~~~面
雨面蕩ま0310813319
1:03'4/040/00090/AM18/ 117.0,1翌
11、_
一
‐
‐
‐
‘
…
…
．
＾
．
岬
‐
‐
‐
‐
‐
―
一
メ/
1器星鬼
5餅004 H ttMlν
:RLA File
i05/23/040/00029/AM18/
ILic.No/Date:0510402566
116.05.2017
IDecision:丁he Committee decided to rat:fy norms based on the recommendation of
D/o Pharmaceuticals forwarded vide O.M.No35011/327/2015-PI(Norms)dated January′
iZOL8, uploaded at the end of these minutes or as applied by the firm whichever is less
lunder para 4,07 of HBP Vol.1. RA concerned may take necessary action as per decision
lof NC.
I
Ｆ
Ｉ
・
ｏ
．
ド
ー
iDecision : Deferred
Date:
.02.2018
Date:
Date:
0310813336
.02.2018
一
‐
８
５
「
ci:きヽ。。
:jO/9'jう_ALё 4′
'61'
I
鴨既
5υO:81:/1↓lj~
Party Namc:ORCH
ILABORATORIES INDIA
LTD
IRLA File
:09/24/040/00089/AM18/
IMcet No/Date:9/82‐
PVT:ALC4/2017
27.12.2017
ILic.No/Date:0910065055
l17.05.2017
IDeclslon:Deたrred
IHQ File
l101/82/050/00788/AM18/
IPa:ly Name:PORUS
LABORATORIES PVT LTD
‐RLA File
i:09/24/040/00041/AM18/
'Mect No/Date19/82‐
‐ALC4/2017
127.12.2017
「
いeN∝5yり8卜ALC″2017
晨
LA Filも
‐~~lビ
iよヽじ壱面肩b01o065060
.02.2018
,..ogt24to4oto0088/AMt8/ i17.05.2017
ド例7
Patty Nanlc:BIO TECH
loPHTHALMICS PVTl
`27.12.2017
lcase No.:351/4/82‐
|ム■ハ″′うnl'
彿五千責乱MIcS PVT LTD:AL彎賀リ
IMcet No/Date:9/82‐
IALC4/2017
|オ｀し'マ
′4V=′
,7.12.2017
‐~~E両面扇teЮ910065073
118.052017
「
需
せ器
NMS MPEX
IRLA File
103/94/040/00150/AM18/
Party'Nanre:Cll)LA
mttα
ⅥⅥMЁ5LABS夢
i猟rα
ツ紗‐
Date:
:Approved
脇蕊鳳訂蹴岬ぃ
撫濯舞轟椰師
188B,:ililr11:l:uillillお露
al∫:fll:T:]|
iii1.tffi'fi1;:il,:;::'.; il" ;:, or these minutes or as appried bv the rirm
iwhichever is less ;;*-;r.
-4..0)7
of HBp Vol.1. RA concerned may take necessary
laction as Per decision of NC'
klaseヽも::43'0ノ患2‐ALこ4′
'biウ
||五農y NameiGRANULES
. INDIA LIMITED
l l lblり
1ハし1
1
|
189亀A rile RLA File
189鴨星魚
90077ν AM剛
|ヽもおヽお
n:be絶||:
:09/24/040/00074/AM18/
阿
冊
lcase No.:388/4/82‐
:ALC4/2017
3多一
::llll:1
IDecision:Deferred
Meet No/Date9182-
1871鵠既::/::78餅AMlν
Ｆ
Ｌ
ド
ー
ｄ
Ｓ
ｔ
ａ
ｔ
ｕ
ｓ
‥
¨
IALC4/2017
IRLA Filc
:03/94/040/00162/AM18/
1針
"盤
了
1器品児
5υ0041″AMlツ ド
|:ち,|:α 9996y今甲γ_芝亜亜
「
1鷺ユ
,く
RLA File
_1 1
‐
―
192ibetiζ i61 :十Aeこ6キirnitiLと しさ
`i古
ea l。 ,ちiify n。|1執s based on the recornrnendatiOn of
lD/o Pharmaceuticals fOrwarded vide O.M. No35011/870/2015-PI(Norms) dated
INovember′ 2017′ uploaded at the end of these minutes or al appli,diby t'1_11里
whichever is less under Para 4'0
4.O7 of HBP Vol.l. RA concerned may take necessary
lacJon as per dedJon of NC.
i
Cur. No.:353/'{/82-
Pmy NttncSTE面LЁ ｀Ы A Ⅲ贅w腎
“
982‐
PRIVATE LIMITED
一
９
３
|百0「il`
:01/82/050/00312/AM18/
IDeclslon:Deferred
‐RLA File
IRLA File
i:09/24/040/00052/AM18/
~~"irty｀
五品ёisUVEN LIFE
IsCIENCES LIMIT,P
Defer Date:
.02.2018
Meet No/Date:9/82‐
IALC4/2017
127.122017
ド
」ζ
`｀
0・わた
'lAtё
4/26fり
IPaiy NameiSUVEN Ы FE
lsCIENCES Llヽ41TED
~Libiヽも
/Datei0910065089
123.05.2017
旺
IRLA File
l:09/24/040/00010/AM18/
~索 E覆裏
:重
|
|
Status:Approved
ALC4/2017
27.12.2017
:ALC4/2017
'7.12.2017
titttb話赫
122.05.2017
,5m星篤
:007鴇ハ
MⅣ
I
r"
, __,Decision : Deferred
,I喰罷淵∬
/9/82-
_1り
Iζ
⌒
', pily N ;; ; r"r nH irtae r-r F E iM ;t N "/Dttt' 9/8,-
SCILNCES PVT.LTD.
ALC4I2O17
.
"2',1.12.2011
1鴨轟鬼
::/0016″ AMlν
だLA Flle ‐
Lil、6′ b五お1051赫
i活あ4/640/00045/AM18/ 22.05.2017
.02.2018
IDecision:Deferred
:05/24/040/00078/AM18/
lcase No.:356/4/82‐
'ALC4/2017
Date:
ハ
ir-ro iit.
lRt-1, pit.
Lic'No/Date:0910065088
i'---'
rt.\AAtAAAl r/Af,flo/
.r?n(?nl7
i,oilsj,6ro/o0787iAMl8/ '.:0et24t040to00ll/AM18/ 23.0s.201'7
i
iDecision : The Committee decided to ratiiv norms based,:l^lry-r.-tt^::T"ll,tt':1:j
νししユ
。
lυ "・
H:しν
V口……――
u高:[ふde olM.No35011 1/318/2017-PI(Norms)dated
iD/o PharmaceutiCals fOrw
INovember′ 2017′ uploaded at the end Of these rninuteS Or aS apphed by the flrm
|::ll:liよ∫::illlislll∫|卜lira 4.07 of HBP VOI.1. RA concerned may take necessary
一
ν
一
一
iParty Name:TRION
iCHEUICEIS PRIVATE
iMcetNo/Dtte:9/82‐
lALC4/2017
127.12.2017
LIMITED
I跳ち刷
:υ0053餅AM17
壼僣熱雨
tЮИ
0332酵駐
.毀:
３
ｃ
一
一
「
,罷癬"扇‐
12脇|‖畔l.
鴨総雷皇悧ITED
RLA File
i :03/941040/00 I 32lAM I 8/ 静酔
需蕊1協認｀
DO
IЪち漏
liOЮoo9θ AMlν
ゝ均
ILi`:｀3'bate:o910065091
Date:
.02.2018
ハ
lcase No.:404/4/82-
IALC4/2017
IHQ Filc
101/82/050/00412/AM18/
IDeclslon:Deferred
Icasc No.:50/9/82-ALC4/2017
:PaロッName:FRESENIUS IMeetNo/Date:9/82‐
IALC4/2017
1KABI ONCOLOGY。
127.12.2017
1LIMITED
Deferred
搬濡滋
機癬:お漑
~夢
鞍夕序
・
孫源~~言赫“
d
l lLIMITED
l l l::、
1バ■■バξX扁 (1「~~~~~~~~
a--
RLA File
Lic No/Date:0510402751
HQFile
'::ill:^ ^A,\o,,^n,re, i^n.ro'1
,
r:01/82/050/00413/AMt8/':051231040100086/AMl8/30'05'20tr-'-'-i
,rri;;;;;;;r;;
committee decided to ratify norms om"a * it'e recommendation of
1Dlo Pharmaceuticals forwarded vide O'M' No3501U87OlIOLS-PI(Norms) dated
i
lNovem ber,2017, uploaded at the end of these minutes or as applied by the firm
I :ffi.r.r'',
i.r, under para 4.07 of HBP Vol.1. RA concerned may take necessary
ILic.No/Date:0510402750
1RLA File
i ___^,^.^`^^^ハ
^′ Aヽ″10′ |つAnく
ぅn17
7.02.2018
Date:
::05/23/040/00088/AM18/ 30.05.2017
:
,wnlcngvgr 15 1tr5) urrusr Ysr
action as Per decision of NC'
IMeet NO/Datci9/82‐
IALC4/2017
12712.2017
ltitiヽb′Dat8:0910065H0
|~‐ 1lζも｀614j"ё
'■
LC4/261111おNamcGLAND
PHARMA LIMITED
IArl ~DI A「
iは
~
子
051鵠肌
:liliお1↓lj lЪ
I
へFilc
/24/040/00099/AM18/
11ι
`ぶ
も五
ib■高~ ~ ~~
130.05.2017
lfer Date:
.02.2018
‐Patty Name:GRANULES
IN DIA LIヽ41TED
IM8も1ヽも
'5晨
き15/82f~~~
IALC4/2017
127.12.2017
lfer Datel
.02.2018
IЪち刷
iυOololハMlツ
1‐
~lbiζ
`No.:413/4/82-
1 lALC4/2017
1 ‐
:081鵠説5900421竹Mlγ
i btclslon:Deferred
Pcrtr Natne:ALEMBIC
'onXnrrlecr,u [lcALs LTD
1跳ち刷ЪOoo51ハMlツ
,Status:
lDeferred
t
2061
|¨
‐
―
1鴨眺5餅00777AMlν
事桜r駆‐
:
:驀酔TW:爾I
3ダ
rDecision : Deferred
rCase No.:35114/82-
t,ltl-cqtzotl
Pal・ty Name:JODAS EXPOIM
IMeet No/Date:9/82‐
ALC4/2017
127.122017
IRLA File
:05/23/040/00060/AM18/
Decision : Deferred
ICase No。:396/4/82- Party NamclMOREPEN MCCt No/Date:9/82‐
IALC4/2017 LABORATORIES LTD, IALC4/2017
27.122017
酔!1彙Ⅲl藍1彙i:1癬3鰹揮冨蔦蔦
辮選凛」撼辮鱗∫格ギ職[鴛響Wi∬
| .. ____^」
^^:_:^^^`ヽ
:r
い面On aS perdedJon d NC _ ___
}「∬
|
eurty Nu*.:VtnCHOW -iMttt N"/D"I"9SI f"t*t
i
;;iRdH;r'aicer- PVr LrD ,:i?:::r'l
iDererred
l-- , ,'----- ^::-:-;;-H;=-
nr A r:,^
:Lii.No/Date:0910065116 lDefer Date:
,\Ln r ,!
:Lit'No/Dutt:0910065116 l*ltl ?
::09t24t040100316/AMl7/ !: l 'os'zotz
loz'oz'zota
IMcetNo/Date:9/82‐
IALC4/2017
,7.12.2017
',Lt.:N"lD"t.'J9
t ooos t t :
lgt.os.zotz
Decision : I)efe rred
―
一
―
一
一
一
一
一
一
~一
一
慮
~'~~
Party Name:V.D'11
1 1Decls10n:Detrred
酢…蕉
面申燕鶉,IJ肥=匹
ふIIII
'T3tase Nα
`8響
82-
IStatllS:1) eferred l
Status:Approved
夕ι
饉ヽ
出
33鬼5剛%yAtt ν
lё ist Nる。
111/9/82-ALC4/2017
Date:
.02.2018
1器島児
5餅0079VAMlγ
IALC4/2017
1器晶鬼
5α0049αAMlν
IRLA Filc
l:05/24/040/00109/AM18/
:ALC4/2017
.27.122017
Lic.No/Date:0510403024
:05.06.2017
: Deferred
IS10n
Ｃ
一
ｅ
一
Ｄ
ICase No.:441/4/82‐
.ALC4/2017
Parfy Name:LUPIN LIMITED IMeet No/Date19/82‐
IALC4/2017
127.12.2017
7171HQ‐iぉ
|:01/82/050/00449/AM18/
,Declslon:Deたrred
′19神01il`
IRLA File
l:03/95/040/00196/AM18/
昨癬
3/4/82‐
椰淵
i鮮黙
FE夢‖纂
FttT薦
Ψ甘1_1∬
| 1鴨説:j:li4VAMIν ttλ ]::0901,.
「
811ヽ
1111塁:|11掛i質:li:if of theSe rrlinuteS Or as applled by the lirrn
,P vol.1. RA cOncerned may take necesSary
睦癬続:~部漱需託1渡盟萱1_
冊島憶
11話111:ヽ咄0側溜
AMν
棚ち革
II二五亜虹
_
ヽ
^鷺
1点1ふil~‐聯齋垂評野両面百万百臨蕊丁
「
liζも
｀
6:化3/9肩「
lT:「:「li4::l「1'1譜
:ITず
:
子
20野
,,||::?llYlγ __
| IDecisiol,Peferl,1
iP;try Name:SHODHANA
iLeeoneroRlES LTD
lMcetN3/Dtte'/82‐
lALC4/2017
IRLA File
l:09/24/040/00135/AM18/
3升
Date:
.02.2018
ALC4/2017
Party Name:DELTA
IFINOCHEM PVT,LTD
iALC4l2017
"27.12.2017
- L,..NJo"t"o: r ot r :zg I
I
i06.06.2o l7
Date:
.02.2018
‐Declslon:Deferred
12712.2017
11,従ガ∬″
782‐
ILお:｀も′
biよbうloo`5i百0「
~~~~~~――一一―
IHQ File ‐RLA File
101/82/050/00806/AM18/ :09/24/040/00530/AM17/ 0806.2017 1
pttdon:The Committee dttdedわは
P(::∬1:テ:::ぷ轟1器黒罫
el鞘
l∬
1路′
Ⅷど布』
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‐2712.2017
ICase No.:68/9/82‐ ALC4/2017
2221百0「il`
|:01/82/050/00795/AM18/
,1tDecision : Deferred
| IDecls10n:Deたrred
IRttδ‖隠Ъ響害D.I造:脳鸞
・り
82-
‐2712.2017
RLA File
:09/24/040/00107/AM18/
Lic.No/Date:0910065138
108.06.2017
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| " , ,-,*":
223 [..irion : The Committe. decided to r.tity nottt based on the recommendation ot
iD/o Pharmaceuticals forwarded vide o.M. No3501U3,,1??,]:|!,["':'}".0?l*
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Lic.No/Date:0910065152
Defer Date:
12.062017
.02.2018
‐Declslon:Deferred
229
ICase No.:467/4/82-
IALC4/2017
,ParりName:SUPRIYA
:LIFESCIENCE LTD
IMcet No/1)ate:9/82‐
IALC4/2017
127.12.2017
~感
8蔦扇
面
而
面
而
112.06.2017
冨面
臨蕊
1::II,こ騒
,Decision i Deferred
IParty NamclASTRAL
ISTERITECH PVT LTD
RLA File
IMectNolDtte:9/82‐
:ALC4/2017
,7.12.2017
1∫嗣需α
340043282 Defer Date:
.02.2018
:34/24/040/00062/AM18/
Ｆ
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Ｉ
』
Ｐ
Ｉ
Ｉ
Ｉ
lCase No.:46314182'
iffiidoii
srERrrECH PVr' LrD'
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RLA File
1器島児
5餅00471性Ylγ__11?γ91γ0906vttYlγ
:ALC4/2017
'7.12.2017
汀
113.06.2017
IPatty Name:HETERO DRUGS
ILIMITED
RLA File
109/24/040/00148/AM18/
f-iCute No.:525/4/82-
. ',ALcaaol1
1233
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"llγ全噌
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i:03 t e4 t 040 t o0? t liAM lgi
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花ま下落死元te:9/82‐ ~~~
:ALC4/2017
1沸.毀:
Defer Date:
Ю7.02.2018
「積壺静」
f仲う
力秘
タク
ILic No/Date:0910065154
Decision i Deferred
t
Date:
ｎ Ｏ Ｃ 一 ｅ 一 Ｄ 一 ‐ ― 二 : Deferred ine pit. I :0 I /82i050/00s29/AM I 8/ rDecision : Deferred Par″ Name:」.B ICHEMICALS& IPHARMACEUTICALS iLIMITED IRLA F‖ e l:03/94/040/00219/AM18/ IMeet No/Date:9/82- lALC4/2017 127.12.2017 | 薔 |こ｀o/D燕疑百面蔽画面τ 115.06.2017 ２ ８ ４ ５ ２ ‐ ７ Ｎ 。 。 ‥ 例 ａ ｓ ｅ Ｌ Ｃ 一 Ｃ Ａ 一 ２ ３ ４ | Ｆ Ｌ ド ー Patty Namc:MYLAN LABORATORIES LIMITED IRLA File :09/24/040/00106/AM18/ ILi`ヽ。 /b:iざ:501oo65176 冊 115.06.2017 I ,0 I /82/050/UU I t 4t AtYt | 6t I ,Decision : -Deferred 術ウ喩厳1:認!:ふI::離競TCツ鯰‐ 「 lcase NQ悧り 8卜ALCる [-1cu.. No.:73le/82-ALc4t20t1 lTIi:T:'X;rl'Iir,r..o iDeferred I I Auv!'lu'|' bntics pnrVere LIMITED ll:"cqnott li.tz:on t I,,,i,oFilerqt^,^^,,,,^^,,o,-@lD.fe'D"t.' I l:01/82/0s0/00800/AMr8/ ',:o9t24t04ot00l3l/AMl8/ 'i--';'-'
tt-^" ir laryヽふmeisHAMS責良ЁЁ IMeetNo/Datei9/82‐ 「 ~マ ||ヽ津攣 伽たが IЫ FESα ENCES LT臥,い LC″2∝7 IIII… … 1鰍 赫 ,(9P'1'竹Yl弘 :1型望二_____ [-i.:,:xo"'rsr^732- ilgm:fir'J?f X;E]"fl,;ct 'lstatus:Dererred I IALC4/2017 ,""''- 'zt.tz.z}tt i ,9檄IⅢ屯驚蕊鵬論協町TIF量奪蔦 ittee decided tO Ca‖ fOr l l ^^■へ +:ハn ハfn/∩ pharmaceutlcalS fOrwarded Vide O・ M・No35011/348/2017- : 1■_^J 07.02.2018 い 話面バ面面 [馘 癬 漁諄詰 … 性ざぽ ご 師 騰就緞蔦j一亀:轟11品IIJ Decls10n:Deferred Date: i 'ffin " ;.o'i; ":"JI ;'ffi 1::" +F : j:::l^'l? i^ 1I- I:::,"' t 348 t 20t7 -' i ,pl(Norms) dated December, 2O!T,uploaded at the end of these minutes and deferred i I - __- _"..) the case. Date: 一 ,7.12.2017
~~降五ζ e、。 .:ζ "/4'82: IALC4/2017 Party NameiKEVA IFRAGRANCES PRIVATE ]LIMITED rRLA File | :03 I 9 4 I O4O I 00226 I AMI I I ‐ 2401111):1):50'::53:'llil:| | 127.12.2017 111:::|!:!l;11 「 :151 「 Itテ [再 「 41'I [ 「 Decision : Deferred | 「 ‐ ‐ ‐ ‐ ＾ “ ‐ ‐ ‐ ‐ ― 41 降ist ttd:4''力8が IALC4/2017 IHQ File 101/82/050/00430/AM18/ IDeclslon:Deたrred IParty Name:MALLADI IDRUGS& IPHARMACEUTICALS ILIMITED IRLA Filc :04/24/040/00057/AM18/ ″| IMeet No/Datei9/82‐ 1針 "鰍 了 Lこ雨o/Dat30410163241 119.06.2017 061' IP:A,｀:m`iSもヤЁヽtifЁ ~l面5JNo/5試e:9/82¨ :~~~lё iξ `｀ も ::jl'0'82-ALё 4; I I SCIENCES LIMITED IALC4/2017 1う,1うOA17 「 ~に 1品｀議嵐わ′二ALё″ '“'lⅢ ,ル■ '11羹 1静Ё ~取 Tl):7α ツ秘 1淵 ed 鳳正三 ′ ,611 11ふ1'Naふも iSマヽ十 iё ‐ ~卜 i`LtNo/Date19/82‐ lALC4/2017 「 ~い も高鳥あ蔑ユLd ic‖ RA“ PV■げD ‐ 一
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| |:ction as per declsiOn Of NC. ‐
一― 一‐
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/4/82‐ ~輝濡fm~獲瑠
45
Status:APProved
Date:
.02.2018
Date:
.02.2018
ICase No.:507/4/82-
Patty Name:CAMPHOR&
:ALLIED PRODUCTS
ILIMITED,
IRLA File
i:03/94/040/00230/AM18/
IMcet No/Date:9/82‐
:ALC4/2017
127.12.2017
Lic.No/Date:0310814175
121.06.2017
IALC4/2017
1HQ File
l:01/82/050/00515/AM18/
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Ｌ
Ｆ
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ICase No.:523/4/82‐
IALC4/2017
|
1器島児
5υ0053 VAM lν
IDeclslon:Deferred
IParty Name:CORAL
iLABORATORIES LTD.,
IRLA File
l:03/94/040/00203/AM18/
IALC4/2017
127.12.2017
:LlciNo/Dat冨面雨面万
121.06.2017
1脇.辮:
Status:APProved
|~｀|:ζも｀ま:49'0たう
:ALёム
''611
1 1
|:●NamelHETERO LABS
LIMITED
|lRLA File
1109/24/040/00178/AM18/
Party Name:HETERO LABS
LIMITED
、RLA File
l:09/24/040/00179/AM18/
IMcet No/Date:9/82‐
:ALC4/2017
'7.12.2017
Li」:ヽo/DIIttD10065202
|::l:1liiii:ii~~~~1
11i:;ill':::l:|||llili‐
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,2.06.2017
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l:0l/82/050/00536/AMl8/:UJ/y4/U4U/UUZ+o/^lYLlv1
, 'Decision : rhe Committee decided to ratifv norms tf:iJlJ1:#i""Hi^il# iJ
1 1D/o PharmaceuJCJS fOrwarded宙
de O.M・
No35011/119ィζり7」lttIり
J''1_■‐
″ジL―
Date:
.02.2018
Meet No/Date:9/82-
IHEALTHCARE LTD
‐
27.12.2017
ICase No.:495/4/82‐
:ALC4/2017
ib..irion : fhe iornrnitt." decided to ratify norms Uisea on the recommendation of
I
",Dlo Pharmaceuticals forwarded vide o'M' No35011/3 46l2}t7-Pl(Norms) dated
rDecember , 2017, uploaded at the end of these minutes or as applied by the firm
'whichever is less under para 4.07 of HBP VOI'1' RA ConCerned may take necessary
taction as Per decision of NC'
end of these
of HBP Vol.1.
minutes or as
RA concerned
applied by the firm
may take necessary
ICase No.:310/4/82¨ Party Name:JUBILANT IMeet No/Date:9/82‐
lALC4/2017 1GENERICS LTD IALC4/2017
1 1 127.12.2017
な♀ユ収`Aハハ.1。′Aヽイ10′ lk'Elinκ
.Lた
。No/D配0510403208
inn40ノ△MlRノ 1,'06,017
101/82/050/00318/AM18/ 1:05/23/040/00049/AM18/ P2.06.2017 1
iDecision : The Committee decided to ratify norms based on the recommendation of
.Dlo Pharmaceuticals forwarded vide o,M. No3501u17312OL7-Pl(Norms) dated
,November , zo;7, uploaded at the end of these minutes or as applied by the firm
rwhichever is less under para 4.07 of HBP Vol.L. RA concerned may take necessary
action as per decision of NC.
ICase No.:559/4/82-
lALC4/2017
1 1Decls10n:Deferred
Palty NanleiS M B
CORPORAT10N OFINDIA
iALC4/2017
,7.12.2017
IRLA File
l:03/95/040/00253/AM18/
鵠PJ~1鼎1漁鰐節=
器艦薦:1鳳lν
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一
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‐CHEMICALS
IRLA File
109/24/040/00136/AM18/
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`ふ`:十
AdёёR
ICHEMICALS
RLA File
109/24/040/00137/AM18/
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'
'7.12.2017
リ
Status:Approved
Defer Date:
1監慧鰈
:"82‐
1淵ed
一
|
ioctober, 20L7, uploaded at
,whichever is less under para
,action as per decision of NC.
Ｆ
Ｌ
Ｆ
Ｉ
Decision : Deferred
⌒
IALC4/2017
m鞣∬ぎPv.
ILTD.
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:03/95/040/00260/AM18/
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i75扁まd蒟両百手ある了
122.06.2017
Defer Date:
.02.2018
lfウ Patty｀atteiヤIttё ttёW ~‐ IM品i｀。/6燕F5/8'‐
iCase No.:52/9/82‐ ALC4/20
1pFTROCHEMICAL PVT LTD.IALC4/2017
PEfROCHEMЮ AL PVT LTD.1針
"獄
v
RLA File
109/24/040/00040/AM18/
i Lic.No/Date:09 I 0065 I 96
\,zz.oa.zotl
ALC4/2017
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‐
‐
２
６
３
‐
‐
lcase No.:513/4/82-
IALC4/2017
IHQ Filc _
,,0 ilezosoloo52l /AM l8/
Decision : Deferred
鶏長ヽ簡li号だ[乳
おら■彎γ今甲γ
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it[.Noloit.:0e10065206 lDefer Date:
ll:0l/s2/050/008l5/AMl8/,,:O9l24l040l0014l/AMl8/e:i.*
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127.12.2017
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,7.12.2017
Datel
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Ｌ
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## Case No.:487/4/82-
y lst cttzott
tuteeiNJoat";9182- Ftrtrt#.ppt-"d I
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肝漑菅蕊Ю
403228「
Palty NameiSENTISS
PHARMA PVT LTD
1器脇5υ0049ykMlν 雌ち漏
::900137AM lν
264 Decision:丁he Commlttee decided
|りeCISlon : ineしorTlrniIIce uet:uじ
ID/o Pharmaceuticals forwarded
November, 20L7, uPloaded at the
lwhichever is less under Para 4.07
iaction as per decision of NC.
to ratify norms based on the recommendation of
vide O.M. No3501U339120t7-Pl(Norms) dated
end of these rninutes or as apphed by the firm l
of HBP Vol.1. RA concerned may take necessaryl
|
ICase No.:80/9/82-
IALC4/2017
IPaty Name:DiVIS
ILABORATORIES LTD
,ALC4/2017
127.12.2017
1鴨既:lili17ハMIツ IЪ瞬
::伊0017吟Ylγ
:|五れ
'｀
五
mき:lkЁ ttЁヽibS McctNo/D:西5/82‐~
壌従ガl∫″
2/4/82-
‐KAB1 0NCOLOGY ALC42017
1 1LIMITED 127.12.2017
--T-
lHQpite.RLAFileLic.No/Date:05104032931
;,oiltztosoloosl0/AMl8/ :05t23t040t00136/AM18/ 30 09:?9tJ - I .--
lbecision : fhe Committee aeiia"O to ritify norms based on the recommendation of
l:olo pharmaceuticats forwarded vide o.M. No3501U870/2075-P:g"t:tl-:11,1
iaction as per decision of NC.
IStatus:Deferredl
‐υ ′υ :::υ =口=Vν ‐― ‐●――・― ‐~
lNovember′ 2017′ uploaded at the end Of these minutiic:ln::]:』
lil:k:yn:lls::器
|
lwhichever is less under para 4.07 of HBP Vol.1. RA co l
1 1「
71檄
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|
常評」需よ画面4437蹄珈:
「
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a:e Nb.:ζJ§/4/82‐
IALC4/2017
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'食
枷″″″秘
;Parry Name:REANNON
iPHARMACEUTICALS
RLA File
:03 195 1040 100288/AM I 8/
―
|
ALC4/2017
2712.2017
:漱蕊x:島県捲恐LTDi造翻席
Cり
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12712.2017
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8輛脱島λ蕊蕊丁~輛
荒1馘i」丁圃蕊需珈警
「丁I二_|
I
,Decision : The committee decided to ratify norms based on the reconr
Status:Approved
´,
ff;;;r;..*i..'r
forwarded vide o.M. No35011/6 4;lzoL3-Pt(Norms) dated 24th
iDecember , 20L3, uploaded at the end of these minutes or as applied by the firm
lwhichever is less under para 4.07 of HBP Vol.L. RA concerned may take necessary
laction as per decision of NC'
‐Lic.No/Date:0910065225
1蠣織∫讐s朦乱Ψ
l--tcur. r,lo.'lObl+iaz - '
iParty Name:HERBOCHEM
I ilr,ccaorz
INDUSTRIES
I
lzoe ,o r,,.
RLA File
I
i'o vszto50/00468/AM l8/
:06124t040100013/AM l8/
i
ib..irion : Deferred
.Dlo Pharmaceuticals forwarded
vide O.M.No35011/349/2017-PI(Norms)dated
end of these rninutes or aS applied by the firrn
of HBP Vol.1. RA concerned may take necessary
iMeet No/Date:9182-
,ALC4l2017
\zt.tz.zott
iLi..NYP"tt'oo r oo: eOs6
05.07 .2017
|こlte N。.:481/4/82‐
:ALC4/2017
1器星泥
5υ0048りAMlν
,ParりName:DALAS
IB10TECH LTD
iRLA File
l:05/23/040/00040/AM18/
Party Name:WANBURY
ILIMITED
IRLA File
l:03/95/040/00306/AM18/
.27.122017
Mect No/Datc:9/82‐
IALC4/2017
I需繭蔽
1沸.毀:
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:Deferred
271 liO1118
101782/050/00524/AM18/
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Deferred
lcase No.:551/4/82‐
:ALC4/2017
1鴨既::/1::::/1↓lj
:o ilszlosoloo4g l /AM 1 8/
Decision : Deferred
IParty NamelRONAK
icHEMICALS
I ―
‐
IRLA File
i:34/24/040/00080/AM18/
Mcet NO/Datc19/82‐
IALC4/2017
127.12.2017
~硫繭
百340043342
118.07.2017
:u::)2男]R1lξ:vT.LTD.
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1103/95/040/00224/AM18/
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Date:
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■2.072017
Ｆ
Ｌ
Ｆ
Ｉ
Lic NO/Datei031 0814571
i lii.N.,lPit" :221 oo I 57 42
IParty NamelRECKITT
IBENCKISER
IHEALTHCARE INDIA
IPRIVATE LIMITED
RLA F‖ e
8/ :05/24/040/00148/AM18/
趾
田調話~
ILic No/Date:0510403484 1Defer Date:
24.07.2017
1 1:01782/050/00557/AM18/
11e凛お
nilⅢⅢII:
I
action as Per decision of NC'
Palty NameiROYAL
PHARMA
RLA File
103/95/040/00345/AM18/
IMect No/Date19/82-
ALC4/2017
27.122017
|
「確癬加f~ 田濡認午
1 1 ~ ^:A`:略
i
ltUou.rnber, ZO!7, uploaded at the eno or rrre>tr r"'i'.':;.::"",
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|
1*f,i.f,"ver is less under para 4.07 of HBP Vol'1' RA concerned may take necessaryi
I
I
r""'-
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: IALC4/2U1/ 11=`｀
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BP vol.1. RA cOncerned may take necessary
ンフー
ICase No.:473/4/82‐ IPatty NameiCADILA 'Meet No/Date19/82‐
IALC4/2017 1HEALTHCARE LTD ALC4/2017
l^"-- -"'
i
t'z''tryon
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lUe pit.
rRLA File
r:0 I /82/050/0048 1/AM I 8/
:08l24lo40l0ol 0 I /AM I 8/
25.07 .201',7
i
lDecision : The Committee decided to ratiiy norms based on the recommendation of
i;i;;;rr."rti..ts
forwarded vide o.M. No35011/33712oL7'Pt(Norms) dated
i;:;.il.;"roir,' ,oroaded at the end of these minutes or as applied bv the firm
,whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary
l
loction as Per decision of NC'
:ξ〕辮輌面アE蕊
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す
一
２
８
０
‐Case No。:482/4/82-
ALC4/2017
IHQ File
:O1/82/050/00490/AM18/
RLA File
:05/23/040/00170/AM18/
ILic.No/Date:0510403522
127.072017
PartyNamttODAS EXPα M監
き淵
ツ
α
"82
1PVT.LTD.,
127.12.2017
07.022018
Decision : Del'erred
IDecision:Deferred
Ｆ
Ｉ
う
。
‐
Ｆ
Ｉ
協g雨3扇雨藤
IALC4/2017
PHARMACEUTICALS
ILic.No/Date:0410163381
128.07.2017
Defer Date:
02.2018
‐Pany Namc:USV PRIVATE
ILIMITED(FORMERLY
IUSV LIMITED)
IMcet No/Date:9/82‐
‐ALC4/2017
127122017
I Li..No/Date:03 I 08 1 4934
'3t.07 .2017
IRLA File
103/95/040/00358/AM18/
LIヽ41TED
IRLA Flle
――――― 「醗雨。
/Dtte:0410163391
|:04/24/040/00091/AM18/ 101.08.2017
Decision : Deferred
lcaζ eヽol:166/0'j':ALё 4たbi7
| _
284 IHQ File
l:01/82/050/00827/AM18/
iDecision : Deferred
| IDecisiOn:DeTr「,d
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61'9/9/§
'ユ
Lむ4ん6"
L二,9F', _
Pany NamciCHEMCON
SPECIALITY CHE～1lCALS
PVT LTD
RLA Filc
:34/24/040/00069/AM18/
F lalty Namも:vЁkё 6~1青AkMA IMeet No/Date19/82-
降ム:も｀3::。ウわた
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ALC4んbil ALC4/2017
1 1RESEARCH
ILABORATORIES PVT.LTD., 127.12.2017
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こ蔦扇面而面薇F
惚路
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:品I111疑帯Ⅲγ型性椰雌
冊
Party Namc:SHIVA
PHARMACHEM LTD
一
Ｃ
一
一
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一
一
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一
一
」
一
Ｒ
ILic No/1)ate:3410043411
,9.08.2017
匂′
~ lLi`:雨研覇ゐF541oo43445
⌒
Date:
Date:
No/Date19/82-
IALC4/2017
12712.2017
| :01/82/050/00826/AM18/
i34/24/040/00025/AM18/
107.09.2017
| IDeclslon:
IPatty NamciSONGWON
ISPECIALTY CHEMICALS
INDIA PVT.LTD.
RLA File
134/24/040/00147/AM18/
IMeet No/Date:9/82‐
ALC4/2017
¨
Deferred
７
０
．
２
一
４
一
Ｃ
一
Ｌ
Ａ
２
８
９
５
０
０
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に
‐
―
―
Ｆ
Ｌ
Ｆ
ト
IHQ File
l:01/82/050/00832/AM18/
1針″猫∵
ILic.No/Date:3410043450
'07.09.2017
rDecision : Deferred
|
「「需癬わ藤
Palty Name:ONEIRO
ICHEMICALS PVT LTD
ILic,No/Datc:3410043452
108.09.2017
:Approved
'HQ File RLA File
101/82/050/00829/AM18/ :34/24/040/00134/AM18/
88ibttiti6五
:十ムとこ
6品品ltiee decided
lD/o Pharmaceuticals forwarded
iNovember′ 2017′ uploaded at the
to ratlfy norrns based on the recornrnendation of
vide O.M.No35011/253/2017‐ PI(Norms)dated
end of these rninutes or as applied by the firrn
of HBP Vol.1. RA concerned may take necessary
| 1翼|‖TI:il冨s選11∫1濯
ra生07
|
Pa■y Name:ONEIRO
ICHEMICALS PVT LTD
IMcet No/Date:9/82‐
ALC4/2017
27.12.2017
:34/24/040/00135/AM18/ p8.09.2917
∠′.:Z.∠υ:/ 1
Lお.ヽ3/D::まう
『loo43451 1
[
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to ratify norms based on the recommendation of
89 ib`titiふ11+hさこ
6品丼
lttee decided
D/o Pharmaceuticals forwarded
i
,November, 20L7, uPloaded at the
I l*hi.h.ver is less under para 4.o7
i
,action as Per decision of NC.
「
~ |こ
aseヽも。
15患/9/82‐ALこ4/】biヴ
,OL卜籠
vide O.M.No35011/253/2017‐ PI(Norms)dated
end of these rTlinutes or as apphed by the firrn
of HBP Vol.1. RA concerned may take necessary
Party NamciSAVANNAH
'ALC4l2017
:.zr.lz.zotl
SURFACTANTS LTD.,
ILic.No/Date:1710006664
108.09.2017
| |:01/82/050/00825/AM18/
I
1 1Declslon:Deferred
lёise No.:101/9/82‐ALC4/2017
Parfy Name:N R OILS
|
「
0百肩
:01/82/050/00828/AM18/
IDeclslon:Deたrred
RLA File
:17/24/040/00049/AM18/
RLA File
:34/24/040/00113/AM18/
Party Name:BEST VALUE
IMcet No/Date:9/82‐
いLC″2017
,7.12.2017
~II需
雪戸面而面丁
IMect No/Date:9/82‐
隔tu∬
|
1躍.器
「「食辮挽が´
1 碑OAお
2921ё:se No.:106/9/82¨ALC4/2017
均f
Date:
|
CHEM PVT.LTD
ALC4/2017
| 1 27.12.2017 1
鵬藤:鳳31鳥L~七珈鶏
Om1/1↓λ
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吻
0043侶21脇
.辮:
'Declslon:Deferred
[-- iCur. No.:104/9/82 -ALC4l20l7 :Party Name:RONAK
i
CHEMICALS
|%lo品
―
| 卜
01/82/050/00831/AM18/
1 1Decision:Deferred
「
~iCaζき｀ふ
lib7り82¨入
LC4
1 1
iCase No.:7/9/82-ALC4/2017
IRLA File
:34/24/040/00138/AM18/
IMeet No/Date:9/82‐
ALC4/2017
27.12.2017
lil..Nolo"t.:+ r OO+3429
irt.oe.zotz
師
RLA File
:34/24/040/00158/AM18/
繭
'
:19.09.2017
剛
IPalty Name:CATAPHARMA
ICHEMICALS PVT LTD.
IALC4/2017
2712.2017
冊
295,責Q rile
l :01/82/050/00734/AM18/
RLA Filc
i31/83/040/00141/AM17/
1脇.獅
tDecision : Deferred
1 1Case No.:108/9/82‐
| IALC4/2017
IPalty Nallle:ASTRAL
ISTERITECH PVT.LTD
l7 iPartyName:PARAMOUNT
AROMACHEM PRIVATE
LIMITED
RLA File
:0 5 I 24 I 040 I 0027 9 I AMI 8 I
IMeet No/Date:9/82‐
ALC4/2017
27 12.2017
IStatus:Approved
０
２
・
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IP‐
~FMcetNo/Dtte:9/82‐
IALC4/2017
127.12.2017
ILi8ヽも,5冨罰5510404104 1Defer Date:
,25.09.2017
ioz.oz.zott
■YFifYゴ___ lυ ′
・
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■LI
IMeet No/Date:9/82-
,裁漱`撃憮
巖hT濡
誡酔輛続
「
~丁~
| ID/o Pharmaceuticals forwarded vide O.瀬I(:::じ1:テ]:1,::殿lli:lIIキllel!譜FI[〔ユ
i
l IMarch′ 2017′ uploaded at the end ofthese minutes or as applied by the lrm whichever
I
lvldlull,
LvLl,
uPlLJdLrEu oL LrrE srru
i
.ir less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per
:
decision of NC.
,
IALC4/2017
Ｆ
Ｉ
Ｉ
「
~~~~~~~~………………
瓢
I:蕊嘉罵i戸
RLA Filc
:34/24/040/00166/AM18/
27 122017
ILic.No/Datei3410043496
126.09.2017
一
一
1脇.辮:
Patty Nallle:SONGWON
SPECIALTY CHEMICALS
INDIA PVT.LTD.
IRLA File
:34/24/040/00167/AM18/
Meet No/Date:9/82-
1針腎綿V
‐
７
一
嵐
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〇
一
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匝
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．
一
薦
Lic No/Date:3410043505
'Decision : Deferred
Status:
Defer Date:
07.02.2018
Party Name:PCL OIL&
SOLVENTS LTD.
IRLA File
105/24/040/00261/AM18/
Mect No/Date:9/82‐
‐ALC4/2017
127.122017
ILic.No/[
Lic.No/Date:0510404163
103.10.2017
1閻¬
厩
1 101/82/050/00744/AM18/
1 1Declslon:Deferred
「
F黒蔽脅動
jふÅ
Lё″ガ
Tウ
ト
2競藤鳥議
1蕊一
Party Name:PCL OIL&
SOLVENTS LTD
RLA Filc
:05/24/040/00280/AM18/
127.12.2017
IStatus:
‐Deferred
Date:
.02.2018
Decision : Deferred
Party Name:PCL OIL&
SOLVENTS LTD.
Mect No/Date:9/82‐
IALC4/2017
127.12.2017
IRLA File
ILic No/Date:0510404193
105/24/040/00284/ANl18/
b4.10.2017
漁協|:酔ふ夢辮あげ胃耐
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|
Fお
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・
LC4/2017
|
障ORに
|:01/82/050/00837/AM18/
Date:
.02.2018
夢猟T純‐
RLA File
:05/24/040/00271/AM18/
ILic No/Date:0510404164
Date:
103 10.2017
02.2018
ILic.No/Date:0510404191
104.10.2017
Ｆ
Ｌ
Ｆ
Ｉ
iCase No.:21/9/82-ALC4/2017
1HQ File
l:01/82/050/00748/AM18/
Decision i Deferred
end of these
of HBP Vol.1.
minutes or as
RA concerned
applied by the firm
may take necessary
ase No。:13/9/82-
LC4/2017
瞬
Ｐ
い
―
晒
IParty Name:B10 TECH
10PHTHALMICS PVT LTD
:Mcet No/Date:9/82‐
:ALC4/2017
27.12.2017
IHQ File
:01/82/050/00740/AM18/
IRLA File
108/24/040/00184/AM18/
ILic No/Date:0810141077
105.10.2017
305 tDecision : The Committee decided to ratify
rD/o Pharmaceuticals forwarded vide O.M.
norms based on the recommendation of
No3501U257 /20t7-Pl(Norms) dated Llth
these minutes or as applied by the firm
Vol.1, RA concerned may take necessary
iDecember, 20L7, uploaded at the end of
lwhichever is less under para 4.07 of HBP
―
‐
一
action as per decision of NC.
1需i静ゴ
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ICase No.:3/9/82-ALC4/2017 1Partv NanleiSTRIDES
SHASUN LIMITED
IMeet No/Date:9/82‐
IALC4/2017
127122017
Status:Approved
307:IHQ File
|:01/82/050/00730/AM18/
‐RLA File
l:04/24/040/00131/AM18/
Lic No/Date:0410163566
105.10.2017
IDeclslon:DeFt・rred
| |^
| ICase No.:25/9/82-ALC4/2017
Palty Nanle:」ODAS EXPOIM
PVT LTD.,
Meet No/Date:9/82-
町
冊
卜
8臨蕊扁
~
iRLA File
:05/23/040/00254/AM18/
ILic.No/Date:0510404221
109.10.2017
IALC4/2017
127.12.2017
| IDeclslon : Deferred
IF凛
口
蝸簾ALC4/狙7
1 1「9聴Ⅲユ■
|‐
Party Nanlc:GLOBAL
PHARMA HEALTH CARE
PVT LTD
RLA Filc
:04/24/040/00137/AM18/
Mcct No/Date:9/82‐
lALC4/2017
127.12.2017
Lic.No/Date:0410163585
1010.2017
町
IDefer Date:
p7.02.2018
∫′一
Ｆ
ド
Palty Name:ARIHANTANAM
ILIFECARE PVT LTD.
IRLA File
IMcet No/Date:9/82‐
IALC4/2017
127.12.2017
Lic No/Date:5210042405
IHQ Filc
| :01/82/050/00738/AM18/
| ,b`cision:De“ |たふ
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肝
ド
ー
:52/24/040/00038/AM18/
F赫面葛面
F
|
IHQ File
l:01/82/050/00737/AM18/
ParりNameiCADILA
IHEALTHCARE LTD
‐RLA Filc
:08/24/040/00207/AM18/
IDeclslon:Deたrred
一
３
‐
２
iCase No.:4/9/82‐ ALC4/2017
:HQ Filc
101/82/050/00731/AM18/
Palty Name:DEEPAK
INOVOCHEM
ITECHNOLOGIES LTD
‐RLA File
:31/83/040/00085/AM18/
IMcetNo/Date:9/82‐
lALC4/2017
127.12.2017
ILic.No/Date:3110066888
112102017
漸需
~議
稲]R 瞬蕩薦
Decision : Deferred
l
F‖ e
―
―
―
岡
Ｆ
Ｌ
Ｆ
Ｉ
iCase No.:8/9/82-ALC4/2017
] :0 I /82/050/0073s/AM I 8/
Pary Name:FINECURE
IPHARMACEUTICALS LTD
‐RLA File
108/24/040/00041/AM18/
ALC4/2017
127.12.2017
127
繭
[
ic.No/Date:0810141158
113.102017
暦
i面玉I
11)eFerred
l
冊
一
３
‐
４
|こ::きヽol:iliわた
,」rtむ4/ibi7
1
,
Palty Name:REINE
LIFESCIENCE
IMeet No/Date:9/82‐
:ALC4/2017
127.12.2017
:01/82/050/00838/AM18/
RLA F‖ e
:34/24/040/00177/AM18/
ILic.No/Datei3410043546
11610.2017
Deferred
1脇.辮:
一
―
IЦ♀′
量収
,Declslon:Dettrred
Party NameiSTRIDES
ISHASUN LIMITED
'Mcet No/Date:9/82‐
:ALC4/2017
12712.2017
1鵬
d
‐RLA File
:04/24/040/00144/AM18/
Date:
.022018
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eヽまゎ′折恵
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bl'latty NaふよFRESЁト
I KAB1 0NCOLOGY
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1,,|ヽ2'1''19171
1Decision:丁he Committee decided to ral
lD/o Pharmaceuticals forvvarded vide
,November′ 2017′ uploaded at the end of these rninutes or as applied by the firm
IWhiChever is less under para 4.07 of HBP Vol.1. RA conCerned may take…
IF霞¨脇~狙7
『
5鳩
t星児
5∽0花餅
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| ,Declslon:Deたrred
"
ILic.No/Date:0410163599
116.102017
一
ｎ
一
〇
一
Ｃ
一
ｌ
ａ
as per decision of NC.
- fc, i. N, .,, liid i Ci - iici io I t
IParりName:CADILA
IHEALTHCARE LTD
IRLA Filc
:08/24/040/00215/AM18/
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5tNo/Dtte'/82‐
|
|引
7澪g鷹泉
j蕊二
'1鳥
j~
IALC4/2017
127.12.2017
Lic.No/Date:0810141214
18.10.2017
IDecision:Deferred
一
３
‐
８
iCase No.:35/9/82‐ ALC4/2017
1HQ Filc
:01/82/050/00762/AM18/
IDeclslon:Deferred
iCase No.:27/9/82-ALC4/2017
Pary Nallle:AETHER
INDUSTRIES LIMITED
RLA File
i52/24/040/00036/AM18/
IALC4/2017
2712.2017
ILic.No/Date:5210042414
23.102017
冊
319
Party NameiHLE ENGINEERS
IPRIVATE LIMITED
,Mcet No/Date:9/82-
IALC4/2017
127.12.2017
Lic.No/Date:5210042416
23 102017
IHQ File
i:01/82/050/00754/AM18/
IDecision:Deferred
IRLA File
:52/24/040/00041/AM18/
lD.f.r D"tt
loz.oz.zo t a
|
‐Case No.:18/9/82‐ ALC4/2017
IPary Name:PCL OIL&
SOLVENTS LTD.
IRLA File
:05/24/040/00312/AM18/
1針
"盤
了
.Lic No/Date:0510404362
12410.2017
3201責Q File
|:01/82/050/00745/AM18/
Decision : Deferred
Paty Namc:SYNNAT
‐PHARMA PRIVATE
ILIMITED
,21柚0日ぉ
| ・o1/Rっ/o
RLA F‖ e
:02/24/040/001081ヽM18/
ICase No。:34/9/82‐ ALC4/2017 Palty Nanle:STRIDES
I SHASUN LIMITED
ICase No.:22/9/82‐ ALC4/2017
監:淵ツαり秘
P7.12.2017
Lic.No/Date:0210207903
24.10.2017
1沸.辮i
i';0tt82t0s0l00749/AMl8/
I
| IDeclslon:Deferred
『
~~1亜
璃雷が~町
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力82‐ALこ枷
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iLIMITED
127 '12'2017
I
irrr rq r,,.
RLA File
l-ic.No /n^t":o2lf2o7go4 i?-.l.I P:l:
I ;0;8r6s0/00750/AMl8/ :02t24t040t001oe/AMl8/ ',zq.rc.zott
107'02'2018
IMeet No/Date:9/82‐
IALC4/2017
127.12.2017
師
54
Date:
02.2018
IRLA Filc
l:04/24/040/00125/AM18/
~lcaζ
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4/261ウ ||:rty7 Na品よMALLAЫ
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I PHARMACEUTICALS
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・∩J/つz1/∩z10/∩∩14つ/ムヽ/flS
Meet No/Date:9/82-
lALC4/2017
127.12.2017
ILic No/Date:0410163624
:01/82/050/00733/AM18/ 1:04/24/040/00142/AM18/
Decision : Deferred
iCase No.:5/9/82‐ ALC4/2017 Palty Name:STRIDES
l lSHASUN LIヽ41TED
Status:Approved
iDeferDate:
107.02.2018
325 Decision : The Committee decided
Dlo Pharmaceuticals forwarded
November, 2017, uploaded at the
whichever is less under para 4.07
action as per decision of NC.
to ratlfy norms based on the recommendation of
vide O.M,No35011/336/2017-PI(Norms)dated
end of these rnlnutes or as apphed by the firrn
of HBP Vol.1. RA concerned may take necessary
iCase No.:24/9/82-ALC4/2017
ParりNamelRECKITT
IBENCKISER HEALTHCARE
INDIA PRIVATE LIMITED
IMeet No/Date:9/82‐
.ALC4/2017
.2712.2017
:::lilll:…
…
1出.尉:
轟Ъ晶掲
5∽"WAMν
iRLA File
l:05/24/040/00320/AM18/
IDeclslon:Detrred
ICase No.:95/9/82-ALC4/2017
IPatty Nanle:ENCEE
IAROMATICS PVT LIMITED
IRLA File
:32/24/040/00024/AM18/
IMcet No/Datei9/82‐
lALC4/2017
,2712.2017
:Lic.No/Datc:3210078279
lol.11.2017
Status:
:Defer Date:
p7.02.2018
Ｆ
Ｌ
Ｆ
Ｉ
IDecision:Deたrred
ICase No.:29/9/82-ALC4/2017 Pa“y NameiBALAJI AMINES
3291 1LIMITED
` :
_J__…
…
…
…
…
…
…
…
…
=
iCase No.:28/9/82-ALC4/2017
:HQ File
i:01/82/050/00755/AM18/
IPany Nanlc:BALAJI AMINES
ILIMITED
IⅣleet No/Date19/82-
IALC4/2017
127122017
‐Lic No/Date:3110066900
IRLA File
|:31/83/040/00091/AM18/
10211.2017
Mcet No/Date:9/82‐
lALC4/2017
,7.12.2017
| |
ゞす
IHQ File
|:01/82/050/00761/AM18/
1魔需abTTI冊輩|
Decision : Deferred
| |
‐RLA F‖ e
:04/24/040/00149/AM18/
lMcet No/Date:9/82‐
IALC4/2017
:27.12.2017
芳∬辮α囲∝“の
51
I
,Decision : Deferred
iStatus:
iDeferred
I
I
⌒
IHQ File
:O1/82/050/00756/AM18/
Decision : Deferred
fCase No.:30 lgt82-ALc4l20l1 Parly Name:BALAJLCMtNeS
LIMITED
Mcet No/Date:9/82‐
ALC4/2017
| |
開脇:三蕊|√
~~所
漱鴻鳳
「
Decision : Deferred
2712.2017
Lic No/Date:3110066901
102.11.2017
1離.辮:
Ｆ
Ｌ
Ｆ
Ｉ
昨
:品｀まふ所患ふALё4た面
7
|
IHQ File
:01/82/050/00758/AM18/
Party Nanle:JUBILANT LIFE
SCIENCES LIMITED
‐RLA Filc
:05/23/040/00255/AM18/
ILic.No/Date:0510404482
102.l12017
Date:
.02.2018
ALC4/2017
27.12.2017
rDecision : Deferretl
Mcet No/Date:9/82-
ALC4/2017
127.12.2017
IRLA File
:05/23/040/00256/AM18/
ILic.No/Datc10510404483
102.11.2017
Defer Date:
.02.2018
∫ろ
Ｆ
Ｌ
Ｆ
Ｉ
Ｆ
Ｌ
Ｆ
Ｉ
榔
3島児
5∽"'Att ν
D ecision : Deferred
Minutes of Manual Cases
## Case No B-01
M No09/AM-18
Date 27 12 2017
ヽЛ/s Makson lndustries Ltd
File No 01/82/050/00451/AM 15
RLA No 03/95/040/00994/AM 14
Adv Auth No 0310776907 dated 03 04 2014
Subiect: Amendment in description of export product.
Decision: The request of the firm for amendment in description of export product has considered
in the meeting. The committee has decided to amend the export product description based on
the recommendation of MSME Chemical division OM No.231212014-Chemical dated 13.06.2017.
The copy of the letter 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.
## Case No. B- 02
M/s Fresenius Kabi Oncology Ltd
M No09/AM-18 1F‖ e No 01/82/050/00788/AM 17
Date 27 12 2017 1 RLA No 05/23/040/00252/AM17
Adv Auth No 0510399569 dated 29 08 2016
fubiggl: Amendment in norms.
Decision: The request of the firm for amendment in norms as per agenda considered in the
meeting. The committee decided to revise the norms based on the recommendation of Deptt. of
Pharma OM No.35011/171l2016-Pl(Norms) dated January, 2018. The copy ofthe letter 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.
AЛ/s Jublant Genercs Ltd
Fie No 01/82/050/00890/AM 17
RLA No 05/23/040/00298/AM17
Adv Auth No 0510400076 dated 07 10 2016
## Case No 3-03
M No09/AM-18
Date 27 12 2017
Subiect: Revision of norms.
Decision: The request of the firm for revision of norms has been considered in the meeting. The
committee decided to revise the norms based on the recommendation of Deptt. of Pharma OM
No.3501 1/4212017-Pl(Norms) dated 2nd November, 2017. The copy of the letter uploaded at the
end of these minutes or as applied by the firm whichever iS less under paru 4.07 of HBP Vol.1.
action as per decision of NC.
## Case No B-04
M No09/AM‐ 18
Date 27 12 2017
ヽЛ/s 」ublant Gener cs Ltd
F‖ e No 01/82/050/00421/ARЛ 17
RLA No 05/23/040/00076/AM17
Adv Auth No 0510398582 dated 24 05 2016
Subiect: Correction of norms.
Decision: The request of the firm for correction of norms has been considered in the meeting.
The comments from Deptt of Pharma ls avvated itis decided tO deferthe case to 07 02 2018
ゞ汁
## Case No. B- 05
I M/s. Lakeland Chemicals (lndia) Ltd
M No09/AM-18 1 File No 01/82/050/01443/AM 15
Date 27 12 2017 1 RLA No 03/95/040/00629/AM14
Adv Auth No 0310790966 dated 12 11 2014
Subiect: Fixation of norms.
Decision: The request of the firm for fixation of norms has been considered in the meeting. The
comments from Deptt. of Pharma is awaited. lt is decided to place the case in next forthcoming
to be held on 10 01 2018
## Case No. B- 06
M/s. Lakeland Chemicals (lndia) Ltd
M.No 09/AM-18
L rite No 01i82/050/01408/ AM 15
Date 27.12.2017
| RLA No 03i95/040/00628/ AM'14
Adv Auth No 0310791049 dated 13 11 2014
Subiect: Fixation of norms.
Decision: The request of the firm for fixation of norms has been considered in the meeting. The
comments from Deptt. of Pharma is awaited. lt is decided to place the case in next forthcoming
to be held on 10 01 2018
**ネ****十*****
_ゞ′
r-\
\:I-,
F. No.350 11 177 41201 5-Pl (Norms)
Government of lndia
Ministry of Chemical & Fertilizers
Department of Pharmaceuticals
Shastri Bhawan, New Delhi,
Dated: JulY 5, 2016
Office Memorandum
Sub: - Fixation of norms - Application of M/s J.B. Chemical & Pharmaceuticals Ltd.
The undersigned is directed to refer to DGFT U.O. No. 0118210501014401AM-
16/DES-3 /1595 dated 15t0112016 forwarding an application of M/s J.B. Chemical &
Pharmaceuticals Ltd. for fixation of norms against export of 1 composition of Difflam
Brand Sugar Free lozenges and 2 compositions of DURO-TUSS dry cough lozenges.
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. This issues wnh the approval of Director(Pharma lndustry).
― ―(Rai Kumar)
Under Secretary to the(3overnment oflndia
Phone:23071162ノUsp:3¨Pharrna@niC.in
Directorate(3eneral of Foreign Trade,
Depalment of Commerce,
(ShⅢ M V Singh,FttDO),Udy09 BhaWan,New Delhi.
Product to be Exported
Raw materials to be imported
Ｓ
．
蘭
Description
Q″anffy
S N0
Description
Quantity in gm
for 100 lozenget
Difflam Blackcurrant Sugar Free
Lozenges. Each lozenge contains
Pholcodine 5.50 mg, Benzydamine
Hydrochloridel.50
mg,
Cetylpyridinium Chloride 1.33 mg
mg and lsomalt ST-M 2141.64 mg
100
lozenges
Pholcodine
0.561
2.
Benzydamine
hydrochloride
0.153
3.
Cetylpyttdlnium
Chlo百de
0,1356
4.
Isomalt ST―M
214.164
2
Duro Tuss Dry Cough Lozenges
Sugar Free Orange, Each lozenge
contains Pholcodine 5.50 mg,
Cetylpyridinium Chloride 1.33 mg
and lsomalt ST-M 2141.64 mg.
100
!ozenges
Pholcodine
5.61 mg
2.
Cetylpyridinium
Chloride
0.1356
3
lsoman ST― M
214.64
3
:器岸麓謂猟
C°
こ:鳳
Lottl::
contains Pholcodine 5.50 mg,
Cetylpy画dinium Chlo面de l.33m9
and lsomalt S丁―M2141.64 mg
100
lozenges
Pholcodine
5.61 rng
2
Cetylpyridinium
Chloride
0.1356
3.
lsomatt ST―M
214.64
∫9
F. No.3501 1/75 12016-Pl (Norms)
Government of lndia
Udyog Bhawan, New Delhi,
Dated: July, 2016
Office Memorandum
## subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (vol.l) 2009-14
Case of M/s DSM Sinochem Phamaceuticals lndia Pvt. Ltd'
The undersigned is directed to refer to DGFT U.O.No. 0118215012011AM-17/DES-
31270 dated the Bnn6 vide which application from M/s DSM Sinochem
Pharmaceuticals lndia Pvt. Ltd. was sent to this Department for fixation of norms under
para'. 4.7 for the export of Amoxycillin Trihydrate through 6-APA route through
Enzymatic route. 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
for 1 kg Export
1
6-amino penicillanic acid (6-APA)
0.55k9
2
Elcolase (Enzyme)
0.005kg
3
D(-) P-hydroxy phenyl glycine methyl
ester
0.47Bkg
2
This issues with the approval of competent authority.
(Rajkumar)
Under Secretary to the Government of lndia
PH -23071162
Directorate General of Foreign Trade,
Department of Commerce,
(Shri M.V. Singh, FTDO),
Udyog Bhawan, New Delhi.
6o
F. No.3501 1 /68 12016-Pl (Norms)
Government of lndia
Udyog Bhawan, New Delhi,
Dated: June,2016
Office Memorandum
## Subject: - Fixation of norms under para 4.7 ol Hand Book of Procedures (Vol.l) 200S-14
Case of M/s Fresenius Kabi Oncology Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1681/AM-
16/DES-3/1829 dated the 1513116 vide which application from M/s Fresenius Kabi
oncology Ltd. was sent to this Department for fixation of norms under para: 4.7 for the
export of lrinotecan Hcl injections 500m9,300m9, 100m9, 40mg' 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:-
DGFT is advised to call following details from the firm viz:-
.1) Complete technical details as per appendix-33 for the manufacture of irinotecan
Hcl 3Hzo (APl) showing mol.wt., % yield on molar basis for each step.
2) Consumption-coefficient of R.M. for 1kg APl.
3) % wastage claimed on API in the manufacture of injections of different
strength/vial size.
2.
(Rajkumar)
PH:- 23071162
(Shri M.V. Singh, FTDO),
Udyog Bhawan, New Delhi
6l
F. No.3501 1 /1 6 4120'16-Pl (Norms)
Government of lndia
Room no.310, B-wing, 3'd floor,
Janpath Bhawan, New Delhi,
Dated: December ,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 Pharmaceuticals Ltd.
The undersigned is directed to refer to DGFT U.O. No. 01/82/050/00454iAM-
18/DES-3i332 dated the 11110t2017 vide which application from M/s Cadila
Pharmaceuticals Ltd. was sent to this Department for fixation of norms under para: 4.7
for the export of Norfloxacin 400mg Tablet. 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 for
1000 tableis
1
Norfloxacin USP
4089m
2)
(Parveen Kumar)
Phone: 23352298
Email: parveen. 1 9@qov.in
(Shri S.K. Panigrahi, Economic Officer, DES-Ill
Phone No: 23061562, (269),
Udyog Bhawan, New Delhi, Email: sk.paniqrahi@nic.in
r.e-
ハ
F. No.3501 1/53/2016-Pl (Norms)
Government of lndia
Room no.3"10, B-wing, 3'd floor,
Office Memorandum
## subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (vol.l) 2015-20
Case of M/s Alembic Pharmaceuticals Ltd.
The undersigned is directed to refer to DGFT U.O. No. 01/82l050/00509/AM-
18/DES-3i37't dated the 17111t2017 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 Procaine Penicillin lnjection 3 Mega. This department has examined
the matter and the following norms are furnished under para 4.7 of Hand Book of
Procedures(Voll)2015-20:―
2.) This issues with the approval of competent authority.
(Parveen Kumar)
Phone: 23352298
Email: parveen.l 9@qov. in
Udyog Bhawan, New Delhi, Email: sk.paniqrahi@nic.in
S
No
lmport item
Norms Recommended
1
Procaine Benzyl Penicillin Sterile lP/BP
315 BOU/1000 Number of
Vials
み
F. No.350 1 1 1221 1201 6-Pl (Norms)
Government of lndia
Room No.310, B-Wing,
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-
31141 dated the 1 +tOAtZOlT vide which application from M/s Optimus Drugs Pvt. Ltd.
was sent to this Department for fixation of norms under para: 4.7 for 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-d-vis actual consumption of all imported imported inputs duly
certified by Central Excise Authorities may be given.
4) oh age of yietO at each step of reaction on molar basis with chemical formula &
M.W. of each chemical involved in reaction.
(Parveen Kumar)
E-mail: Parveen. 1 9@gov'in
Ph-23352298
(Shri S.K. Panigrahi),
Udyog Bhawan, New Delhi.
E-mail: sk.panigrahi@nic. in
Ph: 2306'1 562, Extn.269
′タ
\
（
一
F. No.350'l 1 I 3'l 512017 -(Pl-Norms)
Government of lndia
Dated: December4T, 2017
Office Memorarclgnl
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-20
case of M/s Virchow Petrochemicals Pvt. Ltd.
,/
,/
The undersigned is directed to referto DGFT U.O. No. 011821050/00238,00179
& 00180/AM-18/DES-3/90, 103 & 93 dated the 11612017 vide which application from M/s
Virchow Petrochemicals Pvt. Ltd. was sent to this Department for fixation of norms
under para: 4.7 for the export of GCLE (7-phenyl acetamide-3-chloromethyl
cephalosporanic acid para Methoxy benzyl ester). This department has examined
the matter and DGFT is requested to call Chartered Engineer attested past
consumption certificate.
-
-sL--
<p^*&ll{,}2",t
Phone:23352298
Email: parveen. 1 9@gov.in
Shri S.K. Panigrahi, Economic Officer, DES-Ill
Phone No: 23061 562, (269),
Email: sk.paniqrahi@nic. in
6r
F. No.3501 1/31 812017 -Pl (Norms)
Government of lndia
Room no.3'10, 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 Suven Life Sciences Ltd.
The undersigned is directed to refer to DGFT U.O. No. 01/82l050/00235/AM-
18iDES-3/89 dated the 11612017 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
Amantadine xcqYarureL 100mg. This department has examined the matter and the
following norms dre furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2015-
20: -
S.
No.
lmport item
Norms recommended for 1000
tablets
1
Amantadine Hydrochloride US P
1029m
2.) This issues with the approval of competent authority.
(Parveen Kumar)
Phone: 23352298
Email: parveen. 1 9@qov.in
Udyog Bhawan, New Delhi, Email: sk.paniqrahi@nic.in
66
F. No.3501 1/31 812017 -Pl (Norms)
Government of lndia
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. 01/82l050/00235/AM-
18/DES-3/89 dated the 116t2017 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
Amantadine Hcl Tablets 100mg. 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@qov.in
Udyog Bhawan, New Delhi, Email: sk.paniqrahi@nic.in
S.
No.
lmport item
Norms recommended for 1000
tablets
Amantadine Hydrochloride
1029m
6T
F.No.35011′761′2015‐ P:(Norms)
Government oflndia
Ministry of Chemical&Fert‖
izers
Room no.310, B-wing, 3rd floor,
Janpath Bhawan, New Delhi'
Office Memorandum
Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (vol.l) 2015-20
Case of M/s Fermenta Biotech Ltd.
The undersigned is directed to refer to F. No. 01t82l50l1078iAM-16iDES-3/81
dated the 3t11t2011 vide which an application from M/s Fermenta Biotech Ltd. was sent
to ir,L O"prrtrent for fixation of norms under para: 4.7 for the export of Ergocalciferol
oral solution USP (Vitamin D2 1.0 to 4.0 Mlu). This department has examined the
matter and DGFT is requested to call following information from the firm.
'1 . Quantity of the export product in terms of 1MlU, 2MlU' 3MlU & 4MlU oral
solution seParatelY.
(PaⅣeen Kumar)
Under Secretary to the Government ofindia
E―mail:parveen 19@gov in
Ph:23352298
(Shri S.K. Panigrahi),
Udyog Bhawan, New Delhi.
E-mail: sk.panigrahi@nic.in
Ph: 23061562, Extn.269
ノζ
F. No.350 1 1 13061201 7-(Pl-Norms)
Government of lndia
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-20
Case of M/s Shreejaya Laboratories Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O. No. 011821050/00196/AM-
1g/DES-3/gg dateJ the 01to6t2o17 vide which application from M/s Shreejaya
Laboratories pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7
for the export of 5-Difluoromethoxy-2Mercapto-1H-Benzimidazole. 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@qov. in
Udyog Bhawan, New Delhi, Email: sk.paniqrahi@nic.in
2.)
S. No.
lmport item
Norms Recommended for
1kq export
I
Acetonitril
0.17ks
2
Chloroform
0.'1 8kg
3
Soda ASH
3.03ks
4
Paracetamol
1.43ks
5
Carbon disulfide
0.718ks
6
F22 (Feron Gas) R22 (Feron Gas)
Not allowed being ODS
61
F. No.3501 1 18512017 -(Pl-Norms)
Government of lndia
Office Memorandum
Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-20 case of
M/s J.B. Chemicals & Pharmaceuticals Ltd.
The undersigned is directed to refer to DGFT U.O. No. 011821050100075/AM-18/DES-
3t23g dated the -251912017 vide which an application from M/s J.B. Chemicals &
pharmaceuticals Ltd. was sent to this Department for fixation of norms under para'. 4.7 for the
export of (1.) Benzocaine and Cetylpyridinium Chloride Anaesthetic Throat Lozenges (2.)
Benzocaine and Getylpyridinium
-Chioride Anaesthetic Throat Lozenges (3.) Benzocaine
and Cetylpyridinium ifrloriOe and Dextromethorphan Hydrobromide Anaesthrtic Throat
tozenges. ihis department has examined the matter and the following comments are furnished
under para 4.7 of Hand Book of Procedures (Vol.l) 2015-20. -
(1.) Benzocaine and Cetylpyridinium Chloride Anaesthetic Throat Lozenges. Flavour
Black Gurrent, Honey Lemon & other Flavours: '
S. No.
lmport ltem
Norms Recommended for
1000 Lozenqes
1
Benzocaine
12.249m
(2.) Benzocaine and Getylpyridinium Chtoride Anaesthetic Throat Lozenges. Flavour
Black Current, Lime & Lemon and other Flavours: -
S. No.
lmport ltem
Norms Recommended for
1000 Lozenqes
Benzocaine
10.29m
(3.) Benzocaine and Getylpyridinium Chloride and Dextromethorphan Hydrobromide
Anaesthrtic Throat Lozenges: -
2)
(Parveen Kumar)
Phone: 23352298
Email: Parveen. 1 9@oov.in
Udyog Bhawan, New Delhi-110011
Email: sk.paniqrahi@nic.in
S. No.
lmport ltem
Norms Recommended for
1000 Lozenges
Benzocaine
1.27Ssm
vo
F. No.350 1 1 187 41201 s-Pl (Norms)
Government of lndia
Office Memorandum
|し
,墾
Udyog Bhawan, New Delhi,
Dated: JulY, 2016
鈍卿
留
朧
可
鶏
器
夢
郷
巖
∬・
町∝
“
い
Ⅳ硼"∞
J4
The undersigned is directed to refer to DGFT U.O No.01/82/50/1563/AM―
16ノDES…3/1646 dated the 26ノ2/16 vide which application from A/1/s Siddharth
Carbochem Products Ltd.was sent to thiS Department for fixation of norrns under para:
4.7 for the export of Methy: Salicylate lP′ BP′EP′USP etc.. This department has
exarnined the matter and the fo‖owing norrns are furnished under para 4.7 of Hand
Book of Procedures(Vol.|)2009-14:― |
(Raikumar)
Under Secretary to the Government oflndla
PH:-23071162
Directorate(3eneral of Foreign Trade,
酪階ヽ悪日昭「む
dyog Bhawatt New Ddm
S.No
lmport item
Norms Recommended
for 1kq Export
Salicylic acid
0.955kg
2
Methanol
0.244kq
乃
…
4
r
…
5
Wili
…
2.
7′
F. No.350 l 1 1225 1201 4'PI (Norms)
Government of India
Ministry of Chemical& Fertilizers
UdYog Bhawan,
New Delhi, the August,20l4
Office Memorandum
## Subject:- Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009'14 Case of M/s Aurobindo
Pharma Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01l82l5}ll86/AM-15/DES-31237 dated the 13105114
vide which application from M/s. Aurobindo Pharma Ltd was sent to this Department for fixation of norms under
para: 4.7 for ihe export of Nevirapine (Nevirapine Anhydrous). This department has examined the matter and the
iollowing ror1n, uri furnished under para 4.7 of Hand Book of Procedures (Vol.l)2009'14:
S. No.
Import Item
Qty. Recommended kg/kg.
1
2-Chloro-3-amino-4-methyl pyridine (CAMP)
0.759
2.
Z-chloro nicotinic acid
0.902
Activated carbon
0.100
4.
lyclo hexane
0.898
Cyclo propylamine
0.57
6.
Diethylene glycol dimethyl ether
2.518
7.
Vlethanol
7.124
Ioluene
0.968
9.
Methylene Chloride
1.222
10
Steam/Thermal Coal
As per fuel policy.
This issues with the approval of Director (Cost).
(Raj Kumar)
Pl-Norms
(Shri M.V. Singh, FTDO),
12-
F. No.350 1 1 137 312017 -Pl (Norms)
Government of lndia
Roorrl No.302,3rd Floor,
Janpath Bhawan New Delhi,
Dated: December 21 ,2017
Office Memorandum
Sub: - Fixation of norms under paia 4.7- Application of M/s Optrix Labs Ltd'
The undersigned is directed to refer to DGFT U.O. No'
01/g2l050/00206/AM-1g/DES-3/178 dated the 21logt2o17 vide which an application
from M/s Optrix Labs Ltd. was sent to this Department for fixation of norms against
export of velpatasvir-copovidone. This department has examined the matter and it is
observed that a request for norms againsi Velpatasvir-Copovidone appears to have
been received for the first time. The ipplicant has also not reported any production in
the past and the approvar of the orug bontroiler is to manufacture this drug exclusively
for export.
2.
The applicant has not indicated the percentage yietd on molar.basis and even the
molecular weight of the finished produci appears to ue incorrectly reflected in the
application. Considerinj optimized yietds to a .reasonable level, following norms are
furnished under para +.1of the "rtt"niHrndbook
of Procedures (Vot't) 2015-20: -
3.
The above norms are proposed on ad-hoc basis and may be reviewed in due
course based on the actual "onrurn[tion J"t, achieved by the company for the product
to be exPorted.
4.Thisissueswiththeapprovalofcompetentauthority'
Parveen Kumar)
imported
ProduE to be ExPorted
DescriPtion
0.80 kg
25,5S)-1-
iisl -z -(t, eth oxvca rbo n v I )a miT.,H
il;ihyii;rtanoyil-s-methvl pvrrolidi n-2-
;it-i ;i 1 -dihyd ioisochromeno[4',3' : 6'7]
naphtho 1t,Z-Olimidazol-9-yl)-1 H-
imidazol-2'Yll'4-
(methoxYmethYl)PYrrol idi ne-1 -
1kg
Ve:patasvir‐ COpOVldOne
@nyt)aminol
inhenvl) ethanoic acid
-
T}
F No.35011ノ342ノ2017‐ PI(Norms)
Government oflndia
Ministry of ChemiCal&Fertilizers
Room no.310, B-wing, 3rd floor,
Dated: November '2017
Office Memorandum
Subiect:-Fixationofnormsunderpara4.TofHandBookofProcedures(Vol.l)2015-20
C""L of M/s Sun Pharmaceuticals lndustries Ltd'
U.0カW′ VO‖ ‖・
‖ ‖O u,7群
.品
ljこLok of PrOCedures lVd)2015-20■
furnished under para 4
lmpOn tem
Dorzolamide HydroChiOride
Timo101 Maleate
Norms Recommended fOr
1 000 bOttles
S No
1134259m
348589m
1
2
2)
This issues with the approval of competent authority
J__^A′
^1[ヽう04民_つn_
Under Secretary tO the G:首
::‖:9':::」」も
:
EmJI:parveen 190qoV in
DES― !‖
覇翼箋則;::酔
COm∝L
Udy09 Bhawan,New Delhi
EmJliSk pa面qrahiOnt in
7ヤ
F. No.350 11 187 01201 s-Pl (Norms)
Government of lndia
DePartment of Pharmaceuticals
Office Memorandum
## subject: - Fixation of norms under para 4.7 of Hand Book of procedures (Vol.l) 2015-20
Case of M/s Fresenius Kabi Oncology Ltd'
The undersigned is directed to refer to DGFT U'O' Np' 011821050/01503 &
01502/AM_17IDES-3/1696 & 1701 dated the 1gt2tzo16 & 22tzt20i6 vide which
application from M/s Fresenius Kabi Oncology Ltd'-was sent to this Department for
fixation of norms under para: 4.7 for the eifort of pacfitaxel lniection of 600m9,
300mg, 260mg, 1;fig,'100mg & 30mg. This department has examined the matter
and the following norr', are fuinisfred trnder para 4'7 of Hand Book of Procedures
(Vol.l) 2015-20'-
Norms
Recommended
for 1000
Export item
Paclitaxel
lnjection of
600m9/100m1
@phenyl)-N-
benzoyl-4-phenyl-oxazolid i ne-5-
-Taxus
Baccatta Leqye
Norms
Recommended
for 1000
inieCtiOns
Export item
Paclitaxel
lnjection of
300m9/50m1
@henyt)-N-
henzovl-4-ohenvl-oxazolid
i ne5
7「
“"44-
^
●
carboxlic acid
A
carboxlic acid
6
Taxus Baccatta Leave
542.4kq
For 260mq iniection (43.7m1 in 50ml vial):-
・
０
Ｓ
Ｎ
Export item
・
０
Ｓ
Ｎ
lmport item
Norms
Recommended
for 1000
iniections
Paclitaxel
lnjection of
260m9/50m1
Kolliphor ELP.
22.872kg
2
Ethanol Anhydrous
21.57Ltr.
3
Silica Gel.
5.46k9
4
Cerrous Chloride
27.39ms
5
t+S Snl-Z-(4-methoxY PhenYl)-N-
Benzoyl-4-phenyl-oxazol id i ne-5-
carboxlic acid
305.769ms
6
Taxus Baccatta Leave
470.106k9
Norms
Recommended
for 1000
Export item
Paclitaxel
lnjection of
150m9/25m1
Ethanol Anh'
GS 5 R)2-(4-methoxY PhenYl)-N-
benzoyl-4-phenyl-oxazolid i ne-5-
Norms
Recommended
for 1000
iniections
Export item
Paclitaxel
lnjection of
100m9/16.7m1 in
50ml vial
Cerrous Chloride
117.69ms
@yphenyl)-N-
benzoyl-4-phenyl-oxazolid ine-5-
Taxus Baccatt■上≦型里呈
v6
6ot'4et- .q
carboxlic acid
For 30mo/5ml iniection:-
Norms
Recommended
for 1000
Export item
Paclitaxel
lnjection of
30mg/5ml
(assRl -z (4 - m eth o xy p h e n Y I ) -N -
Benzoyl-4-phe nyl-oxazolid i ne-5-
Taxus Baccatta Leave
And 7 to 13 import items are as per packing policy'
2.) This issues with the approval of competent authority'
(Parveen Kumar)
Phone.23352298
Email: Parveen' 1 9@qov'in
Directorate General of Foreign Trade'
'cT,?3T.:H;iffiil,:;::";mic orricer, DES-il
cz
inone No: 23061562, (269)'
Email: sk.Paniqrahi@nic'in
7T
!-
A
Ｓ
．
Ｎ
。
．
一
‐
・
０
Ｓ
Ｎ
lmport item
Kolliphor ELP.
2.65k9
2
Ethanol AnhYdrous
2.482Ltr.
3
Silica Gel.
660gms
4
Cerrous Chloride
3.39ms
５
一
６
36.969ms
56.826ks
Government oflndia
Ministry of Chemical&Fertilizers
Department of PharmaceutiCals
Room No 310,B― Wing,3rd l。。r,
Janpath Bhawan,New Delhl,
Datedi September 27,2017
0ffice Memorandum
sub: Fixatlon of norrns under para 4.7 of Hand Book Of Procedures(VOl・
|)2015-20 Case of
M′s.Orbit Life Sciences PVt.Ltd.
The undersigned is directed to refer to DGFT U.O'No. 01182150t00091/AM-18/DES-
3/130 dated the 14i0612017 vide which an application from M/s. orbit Life sciences Pvt. Ltd.
was sent to this O"p"rtr"nt for fixation of noims under para" 4'7 for the export of Cefuroxime
Axeti! Amorphous. This department has examined the matter and the following comments are
薔記I馳
=品晶高爵
L′ブ岳百:nd Book Of Procedures Ⅳ
d・り
2015-20ト
2.)
t authoritY'
(PaⅣeen Kumar)
Under Secretary to the(3overnment oflndia
E―mtt paⅣe:11盤謬」
:
Norms
Recommended for
1kg ExPort
7 amino Cephalosporanic acid (D-7ACA)
phonyl lsocYnate (CSIC)
mmo雨um Salt
N DimethYlAcetamide
Ethyt Bromide (AEB)
7/
ハ
F. No.350 1 1 137312017 -Pl (Norms)
Government of lndia
to be exPorted.
4.Thisissueswiththeapprovalofcompetentauthority.
Parveen Kumar)
-
Phone:23352298
ψ
レ
DePartment of Pharmaceuticals
Room No. 302, 3'd Floor,
Janpath Bhawan New Delhi,
Dated: December 21, 2017
Office Memorandum
sub: - Fixation of norms under para 4.TApplication of M/s Optrix Labs Ltd'
The undersigned is directed to refer to DGFT U'O' No'
o1t82tO5o/00206/AM-18/DE-S-3/178 dated the 21t}gl2o17 vide which an application
from M/s Optrix Labs Ltd. was sent to this Department for fixation of norms against
export of velpatasvir-copovidone. This department has examined the matter and it is
observed that a request for norms againsi Velpatasvir-Copovidone appears to.have
been received for the first time. The aiplicant has also not reported any production in
the past and the approvar of the orug bontroiler is to manufacture this drug exclusively
for export.
2.Theapplicanthasnotindicatedthepercentageyieldonmolar.basisandeventhe
morecurar weight of the finished product appears to ne incorrecfly refrected in the
application. considering optimized yields to a .reasonable level, following norms are
furnished under para 4.1of the .urr"nt Handbook of Procedures (Vol.l) 2015-20' -
wed in due
course based on the actual .onrr.piion data achieved by the company for the product
Raw materials to be imported
Product to be ExPorted
Description
0.80 kg
@5-(2-(2s,5sl-1-
i(S)-Z-(rethoxycarbonyllami n9):?-
rn"it viirrtanoyil-s-methyl pyrrol idin-2-
yl)-1,i 1 -dihydioisochromeno[4',3' :6,7]
iriphtho [1,2-d]imidazol-9-yl)-1 H-
imidazol-2'Y\A-
(methoxYmethYl)PYrrolidi ne-1'
Vel patasvi r-CoPovid one
lZ nl-llnrettr oxyca rbo nyl )am i n ol
(ohenvl) ethanoic acid
7?
Office Memorandum
## subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (vol.l) 2015-20
Case of M/s Sun Pharmaceuticals lndustries Ltd'
The undersigned is directed to refer to DGFT U.O. No. 0118210501002121AM'
18/DES-3il29datedthe1416120lTvidewhichapplicationfromM/sSun
Pharmaceuticals lndustries Ltd. was sent to this Department for fixation of norms under
p"rr, +.i to, tne export of (1) LatanoproLt 1d liTglol Maleate Ophthalmic Solution'
b.oosv,lo.sy"*lv, i.smt llitoncure), (2) Timolol Maleate Long Acting oph-thalmic
iorrtio",O.sY"w/v, Sml '(iimatimsuni,' (S) Latanoprost and -Timolol
Maleate
6hth"t;i"'iotuiion, o.boCv"lo.sy"*iv,'z.smt (Latocom Sterile Eye Drops)' This
J.Iprrtr""in"s examined tf,e matter and DGFT is requested to call valid DML of the
export product from the firm.
(Parveen Kumar)
'
Phone.23352298
Email: Parveen.l 9@qov in
Department of Commerce'
(Shri S.f. Panigrahi, Economic Officer, DES-Ill
ihone No: 23061562, (269),
Email: sk.Paniqrahi@nic.in
F. No.3501 1 /34212017 -Pl (Norms)
Government of lndia
ノ
ι
一
ρ
F No 35011ノ256/2017-Pl(Norms)
Government of!ndia
Department of Pharmaceutlcals
/0
Room No. 302, 3'd Floor,
Janpath Bhawan New Delhi,
Dated: December 1 1, 2017
Office Memorandum
Sub: - Fixation of norms under para 4.7- Application of M/s Apex Pharma'
The undersigned is directed to refer to DGFT U.O. No. 01l82l05ol0o274lAu-
18/DES-3/207 datei the 22t1gt2117 vide which an application from M/s Apex Pharma'
was sent to this Department for fixation of norms aga!n9! export- of Selamectin 67o
SPOT ON (each pipette containing Selamectin BP 6% W/V or 60 mg/ml)'
2.
Earlier also in connection with a similar application received vide DGFT OM No'
01/82lo5o/00331/AM.17IDES.3t24BdaledoSloT12016.Sinceadequateinformation
"Uori tf," quantity contained in each pipette to be exported ' was not available' DGFT
was advised to direct the company io furnish additional information vide this Office
Letter No. 35011/158/2010-it-f'lorms dated 15th March 2017. A copy of the letter is
attached for reference.
3.
Since the present application also contain the deficiencies earlier communicated,
the DGFT may like to again direct the company to provide relevant information so that
if," ,"qrir"r"nt of each unit of the export consignment to be worked out'
Encl: As above
Parveen Kumar)
Phone: 23352298
Email: Parveen.l 9@qov in
Phone No: 23061562, (269)'
Email: sk.Paniqrahi@nic.in
ム
`/
ヘ
/θ
F. No.350 1 1 13861201 7-(Pl-Norms)
Government of lndia
Office Memorandum
Subject. - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-20
case of M/s Naari Pharma Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O. No. 011821050100211/AM-
18/DES-3/137 dated the'1 416t2017 vide which application from M/s Naari Pharma Pvt.
Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of
Levonorgestrel 1.Smg Tablets. This department has examined the matter and DGFT
is requested to call DML from firm.
(Parveen Kumar)
Phone:23352298
Email: parveen. 1 9@qov. in
Email: sk.panigrahi@nic. in
g弁
F. No.3501 1 /347 12017 -Pl (Norms)
Government of lndia
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. 0118210501002231AM-
1B/DES-3i268 dated the 4l1Ot2O17 vide which application from Mis Cadila Healthcare
Ltd. was Sent to this Department for fixation of norms under para: 4.7 for the export of
lvabradine Hcl. This department has examined the matter and DGFT is requested to
call complete information from the firm as per Appendix-33.
(Parveen Kumar)
Phone: 23352298
Email: parveen.'1 9@qov.in
Udyog Bhawan, New Delhi, Email: sk.paniqrahi@nic.in
e3
Dated: November ,20'17
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (vol.l) 2015-20
case of M/s Godavari Drugs Ltd.
The undersigned is directed to refer to DGFT U.O. No. 01/821050/00348 &
01395/AM-18 & IrDES-3/285 & 201 dated the 5t1012017 & 2210912017 vide which
application from M/s Godavari Drugs Ltd. was sent to this Department for fixation of
noims under pa6. 4.7 for the export of Ciprofloxacin Hcl/Base. This department has
examined the matter and DGFT is requested to call following details from the firm.
1 . okage yield at each step of reaction.
2. M.W. of inPuts/outputs.
3. Chemistry involved in manufacturing process along with recovery of solvent.
4. Batch records of manufacturing process.
F. No.3501 1 /338/201 7-(Pl-Norms)
Government of lndia
(Parveen Kumar)
Phone: 23352298
Email: parveen.l 9@qov. in
Udyog Bhawan, New Delhi-1 '1001 '1
Email: sk. paniqrahi@nic. in
.*Ll
F. No.350 11 11412017-Pl (Norms)
Government of lndia
Room No. 302, 3'd Floor,
Janpath Bhawan New Delhi,
Dated: September 27, 2017
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14
Case of M/s Morepen Laboratories Ltd.
The undersigned is directed to refer to DGFT U.O.No. 011821050/00935/AM-
17IDES-3/786 dated the 28t12t2016 vide which application from M/s Morepen
Laboratories Ltd. was sent to this Department for fixation of norms under para: 4.7 for
the export of Atorvastatin Calcium 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.
This issues with the approval of competent authority'
(Parveen Kumar)
Phone:23352298
Email: parveen. 1 9@gov.in
Email: sk.panisrahi@nic. in
g{
Product to be ExPorted
Raw materials to be imPorted
Description
atv.
Ｎ
Ｓ
．
０
Description
QuantitY
Atorvastatin
Calcium
1kg
1+n-Cis;- t, 1 -Dimethylethyl-6-Cyanomethyl-
2, 2-D i methyl- 1, 3-D ioxa ne-4-Aeq!e!e-
0.708 kg
2.
4-Fluoro-alpha-[2-methyl- 1 -osopropyl]-
gamma-oxo-N-beta-diphenyl benzene
butanamide
1.15 kg
3.
Methanol
6.42 kg
4.
Methyl Tert-Butyl Ether (1U291
2.78 kg
5
Tetrahydrofuran
0.80 kg
6
Methylene Chloride
4.48 kg
7.
Diisopropyl ether
3.90 kg
F. No.350l ll03l20l2-PI (Norms)
Government of India
Udyog Bhawan,
New Delhi, the 6th June,2012.
Office Memorandum
Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case
of M/s Dhanuka Labs Ltd.
The undersigned is directed to refer to DGFT U.O.No. 0ll82l50ll98lAMI21DES-3/1287
dated the 0lll1lll vide which an application from M/s Dhanuka Labs Ltd was sent to this
Department for fixation of norms under para: 4.7 for the export of GCTA Powder. This
deiartment has examined the matter and the following comments are furnished under para4.7 of
Hand Book of Procedures (Vol.l) 2009-14-
-thiazoyl)vinyll -7-phenylacetylamino- 8-
"*{thi.*1--abicyclo[4.2.0loct-2ene-2-carboxylicacid-4-
S. No.
Import Item
Qty. Recommended kg/kg.
1 GCLE
1.282
つ
乙
Iriphenyl Phosphine
0.726
3. 4-Methyl- 5-Formyl Thiazol
0。769
4 Prpane-1-ol
2_40
5
hloroform
4.27
6. Sodium lodidc
0.41
7 Methanol
1.918
8 Potassium Meta Bisulphite
2.353
2.
This issues with the approval of Economic Advisor.
Q.J.N.Ahuja)
Section Officer
PI-Norms
(Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi.
86
@
F.No.35011′349′2017‐(P卜Norrns)
Government oflndia
Minlstry of Chemical&Fertllizers
Department of PharrYlaceuticalS
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-20
Case of M/s Alembic Pharmaceuticals Ltd'
The undersigned is directed to refer to DGFT U.O. No. 01-1821050100287|AM-
18/DES-3/208 dated the 22lgl2o17 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 Azithromycin step 3 & Step 4. 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.-
(Parveen Kumar)
Phone:23352298
Email: parveen. 1 9@gov.in
(Shri S.K. Panigrahi, Economic Officer, DES-Il1
UdyogBhawan,NewDelhi,Email:sk'paniqrahi@nic'in
2.)
Norms Recommended
・
０
Ｓ
Ｎ
lmport item
Step 3
Step 4
EMhromycin Base USP
1.506kg
1 58kg
2
Hyd roxylamine hYd roctl!el!qe
0.68kg
0.714kg
3
Methanol
1.09kg
2.24kg
4
Methane SulfonYl CUq4Og
0.45kg
0.47kg
5
Acetone
1.27kg
6.45kg
6
Ethvl Alcohol
2 61 Ltr.
2.81 Ltr.
7
Plaunum Metal
0.05gm
0.05gm
`升
F. No.350 1 I 12012016-Pl (Norms)
Government of lndia
Udyog Bhawan, New Delhi,
Dated: 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 lnchem Labs (P) Ltd.
The undersigned is directed to refer to DGFT U.O.No. 0118215011463/AM-
16/DES-3/1838 dated the 1513116 vide which application from M/s lnchem Labs (P) Ltd.
was sent to this Department for fixation of norms under para: 4.7 for the export of
Ractopamine Hcl. 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.
(Rajkumar)
PH'.- 23071162
(Shri M.V. Singh, FTDO),
S.No.
lmport item
Norms Recommended
for 1kg Export
Amino acetonitrile Hcl
1.19kg
>
++itro-metlrarc
No tech. justification is
given in reaction or
process
3
Aluminium chloride
1.717kg
4
Phenol
1.21kq
5
4(4-hvdroxv phenvl) 2-butanone
0.70kg
ζ
F. No.350 1 1 137 012017 -Pl (Norms)
Government of lndia
Department of Plra rmaceutica ls
\*
Room No. 302, 3'd Floor,
Janpath Bhawan New Delhi,
Dated: December 18, 2017
Office Memorandum
Sub: - Fixation of norms under para 4.7- Application of M/s Sterile lndia (P) Ltd.
The undersigned is directed to refer to DGFT U.O. No.
011821050100216/AM-18/DES-3/304 dated the 05/1012017 vide which an application
from M/s Sterile lndia (P) Ltd. was sent to this Department for fixation of norms against
export of Piperacillin Sodium and Tazobactam Sodium Sterile (8:1) for iniection.
2.
This department has examined the matter and it is observed that the applicant
intends to import to raw materials for use in manufacture of the export product after
processing to convert the raw materials into respective sodium salts. No wastage is
claimed and the input are to be imported on net to net basis. Accordingly, the following
norms are recommended which are on as applied basis: -
3.
Parveen Kumar)
Phone: 23352298
Email. parveen. 1 9@qov.in
Email: sk. paniqrahi@nic. in
Product to be Exported
Raw materials to be imported
Description
Qtv
●
０
Ｓ
Ｎ
Description
Quantity for 1
kg
Piperacillin Sodium and
Tazobactam Sodium Sterile (8:1)
for injection
1kg
Piperacillin Acid
0.8910 kg
2.
Tazobactam Acid
0.1090 kg
s7
⌒
\qo
F. No.350l 1160912013'PI (Norms)
Government of India
Udyog Bhawan,
New Delhi, the 24th December, 20 I 3
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case
of M/s Vegesna Labs Ltd.
The undersigned is directed to refer to DGFT U.O.No. 011821501265/AMl4/DES-3/505
dated the l3l1gll3 vide which application from M/s. Vegesna Labs Ltd was sent to this
Department for fixation of norms under para: 4.7 for the export of Magnesium
SalillVtagnesium Mono-p-Nitro Benryl Malonate. This department has examined the matter
and the following nonnr are furnished under para 4.7 of Hand Book of Procedures (Vol.l)
2009-14-
S. No.
Import ltem
Qty. Recommended kg/kg.
l
Para Nitro Benzyl alcohol
0.874
2.
Malonic Acid
1.044
3.
Ioluene
l.00
This issues with the approval of Director (Cost).
(Raj Kumar)
Under Secretary to the Government of India
PI-Norms
"
F. No.350 1'a I 1991201 7-(Pl-Norms)
Government of lndia
Ministry of Chemicals & Fertilizers
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-20
case of M/s Hetero Labs Ltd.
The undersigned is directed to refer to DGFT U.O. No. 011821050/01334/AM-
17IDES-3/1141 da{ed the 21t3t2017 vide which application from M/s Hetero Labs Ltd.
was sent to this Department for fixation of norms under para: 4.7 for the export of
Oseltamivir phosphate. This department has examined the matter and the following
norms are furnished under para 4.7 of Hand Book of Procedures (Vol.t) 2015-20:-
S. No.
lmport item
Norms recommended
for 1kg export
1
Shikimic acid
1.21k9
2
Triethyl orthofromate
3.23kg
3
Methane sulfonyl chloride
1.065kg
4
Triethyl silane
0.65k9
5
N-heptane
3.63k9
6
Diallyl amine
0.42ks
7
1,3-Dimethyl barbituric acid
0.56k9
2.) This issues with the approval of competent authority.
(Parveen Kumar)
Phone: 23352298
Email: parveen. 1 9@qov.in
Email: sk.paniqrahi@nic. in
91
F. No.3501 1/339/201 7'(Pl-Norms)
Government of lndia
Room No.310, B-wing, 3rd floor,
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 Pvt. Ltd'
TheundersignedisdirectedtorefertoDGFTU.o.Np.0l/82l050/00363/AM.
18/DES-3/255 dated the 26tgt2o17 vide which application from M/s Sentiss Pharma Pvt'
Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of
erin"i (erinrolamide Ophthalmic Suspension _1%) Sml. This department has
examined the matter and ihe following noi'ns are furnished under para 4.7 of Hand
Book of Procedures (Vol.l) 2015-20:-
S.
No.
lmport item
Brinzolam ide
Norms Recommended
1
51gm for 1000 injection
2)
(Parveen Kumar)
Phone: 23352298
Email: Parveen.l 9@qov. in
Shri S.K. Panigrahi, Economic Officer,
Udyog Bhawan, New Delhi-11001 1
Email: sk.paniqrahi@nic.in
DES― :‖
q3--
F.No 35011′337′2017‐ (Pi‐Norms)
Government ofindia
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. 01/82l050/00303/AM-
18/DES-3/196 dated the 22tgt2o17 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
aen.tiopin" Mesylate lniection USp 2mg/2m1. This departmery hgs. examined the
matter ind the following' norms are furnished under para 4.7 of Hand Book of
Procedures (Vol.l) 201 5-20:-
2)
(PaⅣeen Kumar)
UnderSecretarytotheGlざ
::‖:「
':::」
ぢも
:
EmJI:parveen 190oOVin
Shri S.K. Panigrahi, Economic Officer,
Udyog Bhawan, New Delhi-'1 1001 1
Email: sk. paniqrahi@nic. in
DES― l‖
S No
1
lmPort ltem
Benztropine MesYlate USP
Norms recommended
2.2gms for 1000 in.lections
ぴ
@
F.No.35011/206/2016-PI(Norrns)
Government oflndia
Department of Pharrnaceuticals
/0
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
Dhanuka Labs Ltd.
The undersigned is directed to refer to DGFT U.O.No. O1t82t50l177lAM-171DES-31283 dated
the 1 1t7116 viOe r,ifrich application from M/s Dhanuka Labs Ltd. was sent to this Department for
fixation of norms under para: 4.7 for the export of Geftibuten USP/EP/BP/IP/JP Powder. 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 for 1kg Export
GHYH(3-OH cephem)
2.977kq
2
Sodium borohydride
0.2108kq
3
Methane sulfonyl chloride
0.968kg
4
Phosphorus pentachloride
1.8515kg
5
Diethvlamine
0.868kq
6
Trimethylamine
3.214kg
7
Ahisol
6.9448kg
8
Ethvl 4-chloro acetoacetate
1.82kq
9
50% benzvl chloroformate
5.0038kg
10
Prenol
3.114kg
Methvl-3-methoxy acrylate
1.62kg
12
Tetra butyl ammonium bromide
0.04776kg
13
Activated carbon
0.200kg
14
DL―malic acid
7.1802kg
15
Phosphorus oxychloride
0.7646kg
16
Sodium methoxide
1.3409kg
17
Acetic acid
5.4957kg
18
Pvridine
0.8438kg
19
Thio-urea
1.0081kg
20
Methane sulfonic acid
0.91 3kg
21
Aluminium chloride
2.388kg
22
Methvlene chloride
80.51 kg
23
Methanol
37.83kg
24
N,N― Dimethvlformamide
21.01kg
25
Ethvl acetate
1.86kg
26
Acetonitrile
9.90kg
27
Acetone
0.88kg
28
Toluene
10.40kq
29
ethanol
1.09kg
9イ
ヽ
、
一
ヽ■ヽ
F. No.350 I I I 4801201 4-PI (Norms)
Government of India
Department of Pharmaceutical s
Udyog Bhawan,
New Delhi,the Ⅳlarch,2015
0fflce Memorandum
Sub: F破ation ofnorms under para 4.7 ofHand Book ofProcedures(Vol.1)2009-14 Case ofh―
1]〕131:を
`21』
[L【≧=』E211百日日FlaF卜(1「」[ョロb(1.
The undersigned is directed to referto DGFT U.0。No.01/82/50/969/AM15/DES-3/996 datcd the
06/01/15 vide which an application fromヽ
4/s.Satya Dccptha Pharl■a Ltd was sent to this Department
for flxation ofnolllls under para:4.7 forthe export ofAbacavir Sulphate.This departrnent has exanlined
thc mater and the following comments are fumished undcr para 4.7 ofHand Book ofProcedures(Vol.1)
2009¨ 14:―
So No.
Import ltem
Qty. Recommended kg/kg.
l
I S,4R)-4-[(2-Amino-6-chloro-9H-purin-yl)-2-
yclopentene- I -methanol hydrochloride
脇81タ
2.
yclopropylamine
0.19''
2.
This issues with the approvalof Director (PI).
(Barnali Khastgir)
Under Secretary to the Government of India
Phone- 23071162
(Shri M.V. Singh, FTDO).
管
-@E=
F. No.35011/22512017-(Pl-Norms) @
,,*,
Government of lndia...
l-f >
Office Memorandum
## Subject: - Fixation of norms under para 4.7 ol Hand Book of Procedures (Vol.l) 2015-20 case
of M/s Enal Drugs Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O. No.01l82l050l1'l335iAM-17/DES-
3/1 128 dated lhe 211312017 vide which application from M/s Enal Drugs Pvt. Ltd. was sent to
this Department for fixation of norms under para: 4.7 for the export of 2,3'Dimethyl-'4-
Nitropyridine-N-oxide. 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
Norrns recommended for 1 kg export
1
2,3, Lutidine
0.85k9
2
Methylene chloride
1 .175k9
3
lsopropyl alcohol
0.46k9
2)
(Parveen Kumar)
Phone: 23352298
Email: oarveen. 1 9@gov.in
Email: sk.paniqrahi@nic.in
1i
Sub: - Fixation of norms against
Contraceptive Sponge.
F. No.3501 1 I 1231201 s-Pl (Norms)
Government of lndia
Office Memorandum
application of M/s Virchow Biotech Pvt.
Shastri Bhawan, New Delhi,
Dated: May 3, 2016
Ltd, Hyderabad, for Today
The undersigned is directed to refer to DGFT U.O.No. 01182105011296/AM-15/DES-3 11294
dated 0410312015 followed by this office communication of even number dated 17th November 2015
seeking additional information.
2) Based upon the information available in a subsequent application of the company circulated by the
DGFTvidetheirU.O.No.011821050100861/AM-16/DES-3/905dated08/09/20l5,theproposalhasbeen
examined and following norms are furnished:
S.No.
(1)
Description of inputs
(21
Quantity worked out per unit
(3)
Nonoxynol 9
0 9983 gm
2
Sorbic Acld
0.0061 gm
3
PrePol HDW-2002
2.4030 gm
4
Sodium metabisulfite Granular
0 0015 gm
5.
Sodium hydroxide NF
0.0015 gm
6
Benzoic acid USP
0.0031 gm
7
Cl‖c acid USP
0 0141 gm
8
Tape Removal
0.2457 yards
9.
Anchoring Scrim
0.0864 yards
10
Mould Cups Bottom
0 0039 Nos
Mould Cups Top
0.0039 Nos.
12.
Pouch- Top Web
0.0233 yards
13
Pouch- Bottom Web
0.0233 yards
14
TDl lndlcators
0.0769 per thousand units
3.
lt may be pointed out that the applicant has submitted a copy of Test License on Form 29 form
State Drug iontroller for manufacture of Drugs for Purpose of examination, Test or Analysis. This
license wis valid till March 2015 only. Accordingly, the DGFT may like ensure availability of valid
Drug manufacturing license for commercial production of the export product.
4) This issues with the approval of Director (Policy).
(Raj Kumar)
Phone. 23A71162
Uspi3-Pharma@nic.in
(Shri MVSingh,FTDO),
Udyog Bhawan, New Delhi.
qT
F. No. 3501 1 1327 12017-( Pl-Norms)
Government of lndia
Dated: January ,2018
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2O1S-20 case of
M/s Dhanuka Laboratories Ltd.
The undersigned is directed to refer to DGFT U.O. No. O1t82tOSOt01357/AM-17/DES-
3/83 dated the 51512017 vide which application from M/s Dhanuka Laboratories Ltd. was sent to
this Department for fixation of norms under para'. 4.7 for the export of Cefixime Methyl Ester
USP/BP/IP/EP Powder. This department has examined the matter and the following norms are
furnished under para 4.T of Hand Book of procedures (vol.l) 2o1s-20. -
(ParVeen Kumar)
Under Secretary to the Government oflndia
Phonei 23352298
Email:parveen 19ooov.in
Email: sk. paniqrahi@nic. in
2)
′子9ノ
lζD
S no
lmport item
Norms
recommended
for 1kq export
1
7¨ Phenylacetarnideo-3-Chloromethyl Cephalosporanic Acid Para
Methoxy Benzyl Ester(GCLE)
1 902kg
2
Triphenyl PhOsphine
1.14kg
3
Acetone
0675
4
N,N Dimethyl Formatti百百75MFl
1.14kq
5
]百石
:15i百こ下
2.01kq
6
Triethylamine
0 32kg
7
Phenol
1.29kq
8
Methanol
5 85kq
9
Activated Carbon
0 10kq
10
Mica Ester
1.14kg
Tetra Hydrofuran(THF)
1.71kq
グ
F. No.3501 1118312017-Pl (Norms)
Government of lndia
Room No. 302, 3rd Floor,
Janpath Bhawan New Delhi,
Dated: November 24, 2017
Office Memorandum
## subject: - Fixation of norms under para 4.7 of Hand Book of procedures (Vol.l) 2oo9-14 case of
M/s BioTech OPthalmics (P) Ltd'
The undersigned is directed to refer to DGFT U.o.No. 01i82/050/01,197/AM-17/DES-311101
dated the 20/03/2017 vide which appiication trom wVs -s
eioTech opthalmics (P) Ltd' was sent to
this Department for fixation of norms unJ"t p""t +'!f9r the export of Bio Hyalur HV 1 ml PFS
(sodium ttyaruronaie ophtharmic soiuiiton 2.4yolrhis department has examined the matter and
ihe fotlowing norms are furnished: -
2.
(Parveen Kumar)
Phone:23352298
[sriri s.r Panigrahi, Economic officer' DES-Ill
Phone No: 23061562, (269)'
Email: sk.Panigrahi@nic'in
1?
ffiimported
viats of 1 ml each
Sodium HYaluronate
1000
vials of 1
ml each
aio nyalur HV 1
ml PFS (Sodium
Hyaluronate
Ophthalmic
Solution 2.4%l
(each ml contains
Sodium
Hyaluronate 24 mg
in 1 mlvials)
earrels (l-lYPak SCF 2.25 ml RF
PRTC FM 27)
Ptunger StoPPer (HYPak BSCF 1-3
mlPH mlPH 701ノ50C BLK S11000
@1-3ml
PP
@zsTll19rl
Cannula (ComPonent for Prefilled
fWvek t-iO (Packing Material)
(Packing material for Prefilled
F. No.3501 1 t87 012015-Pl (Norms)
Government of lndia
Depariment of Pharmaceuticals
Office Memorandum
## Subject: - Fixation of norms under para ffif
Hand Book of Procedures
Fresenius Kabi OncologY Ltd'
Daied: November ,2017
(Vol.l) 2015-20 Case of M/s
Cov.M - 2-
The undersigned is directed to refer to DGFT U.o.. No. o1/82lo5o/01503 & o1 502/AM-17/DES-3/1696
& 1701 dated ne druiola azztztzorol,ii! wr,icnEpprrcatron t., M/s Fresenius Kabi oncology Ltd' was
sent to this Department for fixation ot nor*JJno"ip.r'i, a z toitne export of Paclitaxel lnjection of 600m9'
300mg, 260mg, 150mg, 1O!mg. a gomg. ini. o"plrtr"* l?. examined the matter and the following norms
are furnisheo unoer'pail i.i oin"nd B5ok of Procedures (vol.l) 2015'20"-
ノ
For 600mq iniection (100m1):-
Pactitaxet lnjection
of 600m9/100mt
@phenyl)-N-
Benzoyl-4-phenyl-oxazol idi ne-5-
rax-us gaccatta Leave
For 300mq iniection (50m1):-
Paclitaxel lnjection
of 300m9/50m1
ftnanot AnhYdrous
@henyr)-N-
Benzoyl-4-phenyl-oxazolidi ne'5-
160
lmport item
lmport item
I q9- , Jo
3t
響
ろ
{ 4 e3(r
For 260mq iniection (43.7m1 in 50ml vial):-
on (25m1):-
And 7 to 13 import items are as per packing policy'
2.)
(Parveen Kumar)
etro;;, iiisizgbamail : parveen' 1 e@qov'in
,49/
Paclitaxel
lnjection of
260m9/50m1
21.57Ltr.
N-BenzoYl-4-
phenyl-oxazolidine-5-carboxlffi
faxus gaccatta Leave
FprlSgsj&sli
Koltiphor ELP.
Paclitaxel
lnjection of
150m9/25m1
etnanot AnhYdrous
-BenzoYl-4-
phenyl-oxarolidi@
Paclitaxel
lnjection of
100m9/16.7m1
in 50mlvial
@-N-Benzoyl-
4-phenyl-oxazolidine-S-carboxlic acid
180.810k9
Taxus Baccatta Leave
Paclitaxel
lnjection of
30mg/5ml
-BenzoYl-4-
phenyl-oxazolidine-S-carboxlic acid
b
ヘ
F.No.35011′ 318′2017‐P:(Nor
Government oflndia
Ministry of Chemical&Fertiliz
Department of PharrnaceutiCi
Room no.310, B-wing, 3rd floor,
JanPath Bhawan, New Delhi,
Office Memorandum
## subject: - Fixation of norms under para 4.7 of Hand Book of procedures (vol.l) 2o15-2o case of
M/s Suven Life Sciences Ltd'
百ど
FごЁbOk of Procedures(VOl.|)2015-20:¨
(Parveen Kumar)
Phone:23352298
[Sh* d i. Panigrahi, Economic Officer' DES-Ill
ihone No: 23061562, (269)
iJ;t; Bn"*"n, New'delhi, Email: sk'paniqrahi@nic'in
ffirloootablets
Amantadine HYdrochloride
2.) This issues with the approval of competent authority'
ノ
0」2´―
F. No.3501 1 1336t2017-(Pl'Norms)
Government of lndia
Depariment of Pharmaceuticals
Room no.310, B-wing, 3'd floor'
JanPath Bhawan, New Delhi'
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 shasun
Pharmaceuticals Ltd'
(Vol.l) 2015-20.
The undersigned is directed to refer to
1 . DGFT W&
o i mzlosolo r o-adArrrr- r s/DES-3i307 dated the 6t 1Ot2O17
2. DGFT u.otffi . ofio;Go/ooaziTnnn-1 5/DEs-3/30e dated the 6t 1ot2o17
3.DGFTU.o'l.i;.orlaolosoloo+Ignrvr-ra/DES-3/215dated|he22l9l2o17
4. DGFT U.6.
'Ni;.
OilAZOSOloossa/AM r+iDES-3/264 dated the 4110t2017
5. DGFr u.ffi. oi;8rosoroo+Siinna rarDES-3/21e dated the22tet2017
6. DGFT U.Offi. oiErosdooais/AM i5IDES-3/306 dated the6t10t2017
7 DGFr u ffi ;iEi;Gdooeioffi-r+/DEs-3/261 dated the27tet2017
8. DGFr u.offi. oini,^ioi1$q,iin-ti,Es-3/26e dated the 4t1ot2o,7
9. DGFT u.ffi. otrci,^so^oiizlnrrrr r+IDES-3/263 dated the 4t1ot2o17
1 q,,DGFr r.ffi . oi;;ro;orooeoilffi i aroEs-srsr a dated the 6t 1ot2o17
, ,.fi,DGFT U.O. No. 01/82/O5o/0oa5ilnrta ialoes-glzl8 dated the22t9t2017
-rt DG Fr u . ffi . 0i rc', rcsii t'.iedAM - i alo e s-glz 24 dated the 22t e t 2Q 1 7
vide which 12 apprications f#iii. ciJii" n".itncare Ltd. *r. r"ni to this Department for fixation of norms
under para.4.7for the export of Metopro[i i"rtr"t" raurets rf"2lrg, iorg, 1.0.org' This department has
examined the matter and th" fo*owins ;;;*; ;;iurnished;;;;;E; q.i'or Hani Book of Procedures
(Parveen Kumar)
Under Secretary to the Government of tndia
Phone: 23352298
Deoartment of Commerce'
fii S:ia. ;rnigirhi, Economic officer' DEs-lll'
Phone No: 23061562, (269)'
Udyog Bhawan, New Delhi'
Email: sk.panrqranr(Anic.in
lO)
rforrns rec
toProlol
Esper p"acrrng PolicY
2.)
F.No.35011′ 253′2016‐Pi(Norrns)
Government oflndia
W:星朧需撃冨浩彙11雷ξ
Room no.310,B―Wing,3rd floor,
も:割,3器とが
ew,現キ
)
Office Memorandum
SubleCti l‖
iξ i‖:L:[111冒:詳11∫1』ξll・
7 of Hand B00k Of ProcedureS ⅣOI・|)2015… 20 Case Of
Procedures (Vol.l) 2015-20-
2.02kg
2.)
(Parveen Kumar)
Phone:23352298
rsti'iS.X. Panigrahi, Economic Officer' DES-lll
irnon" No: 23061562, (269), ..
Lil; gh"*"n, nlw'rierni, Emait: sk'paniqrahi@nic'in
ffilkgExPort
珈
:l『|::|::myllanlinol-3-
iydrotttncydふ[3,3,1113,7)ldecane-1-aceuc
aCid(SX00)
雪雨頭鷲認霊璽薫鼻
li∬:~3-
ate(HOBT)
輛ne ttPE村
…
l ether.P励
ノθ″
⌒
F. No.350l 1131612015-PI (Norms)
Government of lndia
Udyog Bhawan,
November, 2015
New Delhi,thc
SubieCt:― Fixation ofnorms undCr para 4.7:11:ff¥≒illrt+≒靖
tcedures(V01・1)2009-14 Casc of…
,
14:¨
(Rai Kumar)
Undcr ScCretary tO thC Gov:棚:塊鴇Tf:3
E)ircctorate Gcnera1 0f Forcign Tradc,
Dcpartment of COmmCrcc,
(Shri lⅥ・V・Singh,FTDO),
Udyog Bhawan,Ncw Delhi
Qty. Recommended.
tOe tZ mg/100 mg tablet
)")"1t". M"*hYdrate USP
′。5
Udyog Bhawan,New Delhi,
Dated:18 May,2016
0fFice Memorandum
Sublect:― Fixation of norms under para 4 7 of Hand Book Of ProcedureS(VOll)2009‐
14 Case of M′ s Shodhana Labs Ltd.
The undersigned is directed to refer to DGFT U O No 01/82/50ノ
1472ノAM―
濯
詠
乱器
3馳鵠』♀懲RIよLWT‖』鰹需露lTL円}R::稲眠認lttl
Alanine Methyi Ester Hci. This department has examined the matter and the
fo‖owing norms are furnished under para 4 7 of Hand Book Of Procedures (VOII)
2009-14:‐
F No 35011/833/2015-PI(Norms)
Government oflndia
Ministry of Chemical&Fert‖ izers
(Ralkumar)
Under Secretary to the Gove:I「F':8;IT:]
Directorate Ceneral of Foreign Trade,
(shn M v singh,FTDO),
Udyog Bhawan,New De!hi
S No
1
lmport item
Norms Recommended for
1 kq Export
L-Alanine
0 75kg
|つろ
F.No.35011ノ348′2017‐PI(Norms)
Government oflndia
Ministry of Chemical&Fertinzers
フlι´
Room no.310, B-wing, 3rd floor,
JanPath Bhawan, New Delhi,
Dated: December '2017
Office Memorandum
Subiect: - Fixation of norms under para 4.7 of Hand Book of Procedures (vol.l) 2015-20 Case of
Mrs Cadila Healthcare Ltd.
The undersigned is directed to refer to DGFT U.O. No. 01/82/050/OO467iAM-18/DES-3/268
dated the 1711112017 ,iOe wNtn apptication trom ME-CaOita Healthcare Ltd was sent to this
6lp'.rtr".i to, fixation of .o.,; ;;#r p;ta: 41 for the export of Mesalamine Delaved Release
Tablets 1.2gm. This oepartmeni has examined the matter ahd.o_Grr.i= lequegE4 to Jgl! tvlEIigq
tnJim Orfy-ipproved by QC manager to calculate Quantity of Excipients'
(Parveen Kumar)
Phone:23352298
Email: Parveen. 1 9@qov'in
tSfiri S.K. Panigrahi' Economic Officer, DES-Ill
Phone No: 23061562. (269)'
UOVog Bn.*"n, New Delhi, Email: sk'paniorahi@nic in
107
0
F. No.350 1 1 134812017-Pl (Norms)
Government of lndia
Room no.310, B-wing, 3rd floor,
JanPath Bhawan, New Delhi,
Dated: December ,20i7
Office Memorandum
## subject: - Fixation of norms under para 4.7 of Hand Book of procedures (vol.l) 2o15-2o case of
M/s Cadila Healthcare Ltd'
The undersigned is directed to refer to DGFT U.o. No. 01t82lo5o/00466/AM-18/DES-3/323
datedthellllyt2llTvidewhichrppti.rtionltgTMi.tc'dilaHealthcareLtd'wassenttothis
Department for fixation of norms ,.#;;;;, 411:llle export of Fenofibrate capsules 67mg'
200mg, 300mg a ieomg. This de_partment has examir:^l ln;^T:1"J.and
the following norms are
ffiilfu;;;1 p"r, 4.7'of Hand Book of procedures (Vol.l) 2015'20.'
2.) This issues with the approval of competent authority'
(Parveen KumaQ
UnderSecretarytotheGovernmentoflndia
Phone:23352298
tSti,"i S.X. Panigrahi, Economic Officer' DES-Ill
inone No: 23061562, (269)'
U;til Bh"*rn, New Delhi, Emait: sk'paniqrahi@nic'in
Nornts Recommended for 1000 tablets
lmport item
赫
PH EUR
lox
F.No.35011′ 346′ 2017‐Pi(Norms)
Government oflndia
電
:騒猟活
:RTT署:1麻」
::11:昴ξ
Room no.310, B-wing, 3'd floor'
Janpath Bhawan, New Delhi'
Daied: December '2017
Office Memorandum
Subiect:-Fixationofnormsunderpara4.TofHandBookofProcedures(Vol.l)2015.20Caseof
'
M/s Cadila Healthcare Ltd'
百よ
Fd ttЬ 6k of ProcedureS IV911)2015-20■
lmpOn tem
4J Dich loroq u inoline
Fydrojrlovaldram'il1e
¨
mended for
lkg export
0 70kg
065k9
S
No
1
2
2) ThiS iSSues With the approval of cOmpetent authOrity
(ParVeen Kumar)
UnderSecretarytOtheGl首
i:‖:「】
:::」Iも:
Emalli parveen 19000V h
DlrectOrate Genera1 0f Foreign Trade,
)nにin
lο9
F.No.35011ノ149ノ2017‐(P卜Norms)
Government ofindia
忠
:騒猟話
:黒讐
T臀:1麻」
::11:昴ξ
Room no.310, B-wing,
JanPath Bhawan, New Delhi'
Dated: October 30,2017
Office Memorandum
Subiect:.Fixationofnormsunderpara4.TolHgrBookofProcedures(Vol.l)2015-20caseofM/s
L.B- Chemicals & Pharmaceuticals Ltd'
folloWing
ICt10n iυ ス
`υ口:: ハ:::PV‐ 1‐‐・ ''¨~ ~―
「
――― ~ 3edures lVOll)2015-20:―
are furnished under para 4 7 of Hand B00k Of Pro{
―
―
lmPort item
Bupivacaine Hcl
Adrenallne Dlranara*
Norms reCOmmended fOr
1000 iniectiOn
|
S No
1
2
2)
(ParVeen Kumar)
UnderSecretarytOtheGl首
::‖::':::」り
8:
Ema‖ :parveen 190qoV m
Deoartment of Commerce'
5ni s.ri. pr"israhi, Economic officer' DES-Ill
Email: sk. Paniq rah i@n ic' in
11つ
Room no.310, B-wing, 3rd floor,
Janpath Bhawan, New Delhi'
Dated: November ' 2017
Office Memorandum
Subiect:.Fixationofnormsunderpara4.TofHandBookofProcedures(Vol.l)2o15.2ocaseofM/s
Jubilant Life Sciences Ltd '
F. No.35Ol 1/1 73l201 7-(Pl'Norms)
Government of lndia
raure.. o rrrs' rv rrrY - --';o'irl"na Book of Procedures (Vol l) 2015-20:-
are furnished under Para 4 7
2)
(Parveen Kumar)
Phone 23352298
Email: Parveen 'l9@qov in
TheundersignedisdirectedtorefertoDGFTU.o-No.01/821050/012oolAM-171DES-3/1100
dated the 2oto3lzo17 rio" *ii"i'rn'rppii.rt'". from M/s Jubilant Life sciences Ltd was sent to
this Department for fixation oi norrr',i"0", para" 4.7 for the export of Escitalopram oxalate
rabrets 5 mg, 10 ms & 20 '; ili;;-";;'1'."1t n" "111'.i::,l1""Hft:land
the forrowins norms
Deoartment of Commerce'
6il s.x.-p"nigrahi, Economic officer' DES-Ill
Udyog Bhawan' New Delhi
Email: sk.Paniqrahi@nic in
for Export of 1 No. Tablet
6.5"17 mg
scitaloPram Oxalate
F.No.35011/28ノ2017¨PI(Norms)
Government oflndia
Department of Pharrnaceuticals
Dated:September 19,2017
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol'l) 2015-20 case of
M/s Satya Deeptha Pharmaceuticals Ltd'
The undersigned is directed to refer to DGFT U.o.No. 01l82t5ol9o1/AM-17/DES-3/666 dated
the 21t1212016 vid"e which application from M/s Satya Oeeptha Pharmaceuticals 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-+-eyrimidinyl) Amino]-2-Cyclo pentene-l-Methanol. 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.)
Thisissueswiththeapprovalofcompetentauthority'
(PaⅣeen Kumar)
under Secretary to the Government oflndia
E…mail:parveen.19(@goV・in
Ph:-23352298
Directorate(3enera1 0f Foreign Trade,
Department of COmmerce,
器:樵靭牌鳴訛Dd師
.
E― maill sk.panЮ rahi@niC・in
Ph:23061562,Extn.269
Norms Recommended for
lkg Export
D(―)Tartattc Acid
Sodium BorohYdride
lsopropyl Alcohol
Methanol
L(+)Ttartanc Acid
11(ユ_
S.No.
0.764kg
1.298kg
2
0.78kg
3
0.226kg
4
4.1 8kg
5
4.75kg
6
0.51 9kg
7
F. No.3501 1/339/201 7-(Pl-Norms)
Government of lndia
Department of Pharmaceuttcals
Dated: November ,20'17
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 Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O. No. O118210501O0495/AM-18/DES-3/335
dated the lgti)l}OlT vide which application from M/s Sentiss Pharma Pvt. Ltd. was sent to this
Olp"rtr"nt for fixation of norms under para: 4.7 for the export of Visallergol Eye Drops 0'2%'
2.5m1. 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
Olopatadine Hcl
Norms Recommended
1
5.66'1 gms for'1000 Pack
2)
(Parveen Kumar)
Phone: 23352298
Email: Parveen. 1 9@qov.in
Udyog Bhawan, New Delhi-11001 1
Email: sk.paniqrahi@nic.in
tt3
F. No.350l 1164612013-PI (Norms)
Government of India
Udyog Bhawan,
New Delhi, the 24fi December, 2013
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case
of N4/s Divi's Labs Ltd.
The undersigned is directed to refer to DGFT U.O.No. 0ll82l50l462lAM'l41DES-3/568
dated the 31l1gll3 vide which application from IWs. Divi's Labs Ltd was sent to this
Department for fixation of norms *na.r para:4.7 for the export of Iopamidol. 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-
This issues with the approvalof Director (Cost)'
(Raj Kumar)
Under Secretary to the Government of India
P[-Norms
(Shri R.C. Meena, Dy. DGFT), Udyog Bhawan, New Delhi'
I tbl
S. No.
Import Item
Qty. Recommended kg/kg.
１
一
２
一
３
Atipa Di Chloride
1.40
2-Acetoxy PropionYl Chloride
0.49
Iso PropylAlcohol
8.13
4.
--
6,
1
&t
Methanol
3.21
N,N-Dimethyl Acetamide
1.46
Di Methyl Formamide
0.78
\itromethane
0.48
robfanrine
a50-
foluene
1.00
The undersigned is directed to refer to DGFT U.o. No. 01t82lo5ol0o287lAM-18/DES-3/208
dated lhe 22tg12017 vide which application from M/s nternnrc pharmaceuticals Ltd. was sent to this
Department for fixation of norms uhoer fara: 4.7 for the export of Azithromycin step 3 & step 4'
This department has examined the matier and the following norms are furnished under para 4'7 of
F. No.350 1 1 13491 201 7-(Pl'Norms)
Government of lndia
Room no.310, B-wing, 3rd floor,
JanPath Bhawan, New Delhi,
Dated. December ,2017
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (vol.l) 2015-20 Case of
M/s Alembic Pharmaceuticals Ltd'
Hand Bbok Of PrOcedures lVd.り2015-20:―
Norms Recommended
Stepl
I
SteP4
S.
No.
lmport item
1
ErythromYcin Base USP
1.506k9
1.58k9
2
Hydroxylami ne hYd rochloride
0.68k9
0.714k9
3
Methanol
1.09k9
2.24k9
4
Methane SulfonYl Chloride
0.45k9
0.47k9
5
Acetone
1.27k9
6.45k9
6
EthylAlcohol
2.61 Ltr.
2.81 Ltr.
7
Plaunum Metal
0.059m
0.059m
2.)Thisissueswiththeapprovalofcompetentauthority.
(Parveen Kumar)
Phone: 23352298
Email: Parveen' 1 9@oov'in
Phone No: 23061562, (269)'
U;t;a Bhr*"n, New Delhi, Email: sk'paniqrahi@nic'in
tt,
F.No.35011′ 337ノ2017¨ (P卜Norms)
Government oflndia
電
:星鷺黒撃鼎滋誂雷ξ
## Subject: - Fixation of norms under
Healthcare Ltd.
“
m4 ettЮ
S Ⅳ硼""∞
鋼
WSCJh
Procedures ⅣOI.|)2015-20:¨
蜀
而S iSSuetth trle approval… 円…
…
瓦
der secretary dm Gギ
構
猥
EmJL parveen 19CDoOV.in
Directorate Genera1 0f Fore19n Trade,
事i電帯
驀
曹
ぷ
蹴
部
副
ヽew田旧
側
γE耐
よ∞面針鋼mm
網研
2」嶋濯需‖
::品TR需&:亀穏
腿露
l点鼎馨熙躍認出鳳増酬
|lι
Export hem
10189200.000
しF:igsty「ど品ine RLsln UsPxAct市e lngredient:ChOleStyramine
Resin USP一Net Wt.40756.80 kgs)
(1XeG
PCH Pack) (each pouch of 9 grams contain 4 grams of
91442.000
ms (1X378G
1ar pacf (Each jar of 378 gms equivalent to 42 pouches of 9 gms
ani each pouch of ggms contain 4gms of cholestyramine Resin
USP) (Active lngredient: Cholestyramine Resin USP
Net
ht pOWder 4 gms
(lX55G PCH PaCk)(eaCh pouCh Of 5 5gms cOntain 4gms Of
■ __1:__■
ハL^]^^●
、′rら― inハ
とi3轟r:鳥e員こξ
n｀usD ttve hりedett Chdettyattne
Resin USP― Net VVt.14079.84kgs)
39111.000
ht Powder 4 gms
(1X231G jar pack) (each iar of 231gms equivalent to 42
'"':-l=:
i.Sgr. and each pouch of 5'Sgms contain 4gms of Cholestyramlne
ResinUSP)(Activeingredient:CholestyramineResinUSP-Net
Foraboveexportproductwemayrecommendfollowingquantityofrawmaterial.
Petent authoritY'
lmport lem
Colestyramrne Resin USP
Sucrose NF
Mannlol USP(PeaJ101 SD 200)
P-----'----'----------'----.pyt"n"cty.olAlg'ngt"xI
F. No.350 1 1 t339t201 7-(Pl-Norms)
Government of lndia
The undersigned is directed to refer to DGFT u.o. No. 01/82/050/00476/AM-18/DEs-3/334
dated the 1g/10/ zo, viaewhich appiication from M/s=enfiss Pharma Pvt' Ltd' was sent to this
Department for fixation of norm, uni"i p"r
^, ii tor tne eiport of Giprofroxacin otic Solution
0.20/o,0.25m1. rhis department I* "T"[j4g tr"*:ii?:.ild
the followins norms are furnished
Room No'310, B-wing, 3rd floor'
JanPath Bhawan, New Delhi'
Office Memorandum
## Subject: - Fixation of norms under para4.7 of Hand Book of Procedures (Vol.l) 2015-20 case of M/s
Sentiss Pharma Pvt' Ltd'
;;i:l ;;;';'.i;i'H;d Book of Procedures (vot t) 2015-20:-
2.)
(Parveen Kumar)
Phone:23352298
Snl S.X. panigrahi, Economic Officer' DES-Ilt
Phone No: 23061562, (269)
Uiyog Bhawan, New Dethi-110011
Email: sk.Paniorahi@nic'in
mmended
SOOf mg for 1000vials
lmPort item
S.
No.
tt7
TheundersignedisdirectedtorefertoDGFTU.o.No.0l/82l050/00480/AM-18/DES-31274
dated the 4l1Ol2O17 rio" *rti"t' ,ppii."tion tron1 M/s Cadila Healthcare Ltd was sent to this
Department for fixation ot noirt unili-para:4.7 for the export of Doxycycline for injection USP
100mg/viat. This departmeni;;.;;;ili!9g{ler anO ihe following norms are furnished under
F. No.3501 1/337/201 7-(Pl-Norms)
Government of lndia
Room no.3'10, B-wing, 3'd floor,
Dated: November '2017
Office Memorandum
Subject:-Fixationofnormsunderpara4.TofHandBookofProcedures(Vol.l)2015.20caseofM/s
Cadila Healthcare Ltd.
pii^it of Hand Book of Procedures (Vol l) 2015-20:-
2)
,
(Parveen Kumar)
Phone:23352298
Email: Parveen.'1 9@qov in
Sh;i S.K. Panigrahi, Economic Officer, DES-Ill
Phone No: 23061562' (269)'
Udyog Bhawan, New Delhi-11001 1
Email: sk. Panio rah i@ n ic. in
Norms recommended
t2&Z3gms for 1000 vials
ine Hyclate USP
3OOgms for 1000 vials
annltol USP
As per packing
policY
ilJSP typef amber molded glass vials
nfU aoune slotted Bromobutyl Rubber
H♂
八
F.No.35011′ 253r2017‐ (P卜Norrns)
Government oflndia
Department of Pharrnaceuticals
JanPath Bhawan, New Delhi,
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-20 Case of
@
The undersigned is directed to refer to DGFT U.O. No. 011821050101316/AM-17|DES-311187
dated the29l3l2O17 vide which application from M/s Tagoor Chemicals. was sent to this Department
for fixation of norms under para: 4.7 for the export of 2-chloromethyl'3,5-dimethyl'4-mehtoxy
pyridine hydrochloride. This department has examined the matter and the following norms are
iurnished under para 4.7 of Hand Book of Procedures (Vol.l) 2015-20:-
S.No.
lmport ltem
Norms Recommended for 1kg
Export
3,5 Lutidine
1.04kg
2
Toluene
0.15kg
3
Methanol
0.763kg
4
Acetone
0.14kg
■
…
6
Ammonium PersulPhate
1.71kg
0臥」
/賂οソ、
o゛ヽ0
2.)
Thも・
ittue3轟lR the approval of competent authottty.
(Parveen Kumar)
Phone:23352298
Email: Parveen. 1 9@qov.in
Udyog Bhawan, New Delhi-110011
Email: sk.panigrahi@nic.in
も
11タ
F No 35011/162/2016-PI(Norms)
Government oflndia
Department of Pharmaceulcals
'
n "'5
"',Joliii;'i % ?? i)
Office Memorandum
sub: - Fixation of norms under para 4.7- Application of M/s Astral Steritech (P) Ltd.
The undersigned is directed to refer to DGFT U.O. No. 01/821050/002811AM'171DES-3/253 dated
the 08/07/251 6 vide which an application from M/s Astral Steritech (P) Ltd. was sent to this
b"prrtr"nl for fixation of norms against export of Piperacillin and Tazobactam for lnjection
USp +.S gm. This department has Jxamined the matter and it is to be clarified that SION A-3672
is already- published for Piperacillin + Tazobactam 2.25 gm lnjections The calculation of the
permissible inputs was based upon SION A-205 for lnjections up to 10 ml'
2) Considering the fact that the size of vial of export product mentioned in this application is 30 ml'
tti" ,"qrir"r"-nt cannot be worked out on pro-rata basis in line with SION A-3672' For injections
about i0 ml wastage has to be allowed in iine with SION A-206 which provides for 5 % wastage'
As such following norms are recommended against this application'
Product to be ExPorted
Raw materials to be lmPorted
Ｓ
肪
Desciption
Qυ an″ly
Description
Quantity for 1000
vials
1
Fiperacillin and Tazobactam
for lnjection USP 4.5 gm (each
30 ml vial contains PiPeracillin
Sodium equivalent to 4 gm
Piperacillin +
Tazobactam
Sodium equivalent to 0.5 gm
Tazobactam.
1000
vials
Piperacillin
Sodium +
Tazobactam
Sodium (8:1 )
(Sterile Powder)
4890 236 gm
(wlh 4332 686 gm
Piperaci‖ in Sodium
+ 557 55 gm
Tazobactam
Sodium)
3) This issues with the approval of competent authority'
Bainali Khastgir)
Phone:23323292
Email: barn.khast@nic.in
(Shri Nirmal Kumar, DY DGFT)'
Email: nirmal.kumar65@nic.in
lρ
⌒
の
´
、
′
′
′
′
′
′
′
′
′
′
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:
F.No.35011/257ノ2017¨ PI(Norms)
Government oflndia
Department of PharrTnaceuticals
_3∂
RoOm No.302,3rd F
Janpath Bhawan New Delhi,
Dated: December 11, 2017
Office Memorandum
Subject:-FixationofnormsunderparffiofProcedures(Vol.l)2o09-14Caseof
M/s BioTech Opthalmics (P) Ltd., Ahmedabad
The undersigned is directed to refer to DGFT U.O.No. 011821050to1469/AM-171DES-3121
dated the 06/04/2017 vide which application from M/s BioTech opthalmics (P) Ltd. was-sent to
this Department for fixation of norms under para. 4.7 for the export of Bio Hyalur Duo (Sodium
Hyaluronate ophthalmic Solution) This department has examined the matter and the following
norms are furnished: -
2.Thisissueswiththeapprovalofcompetentauthority.
(Parveen Kumar)
Phone: 23352298
Email: Parveen. 1 9@qov'in
Phone No: 23061562, (269)'
Uivog Bhawan, New Delhi /Email: sk'paniqrahi@nic'in
/
Product to be ExPorted
Raw materials to be imPorted
D*cription
Qry
●
０
Ｓ
Ｎ
Description
Quantity for f000
viars Of f m′ eac"
Bio Hyalur Duo
(Sodium
Hyaluronate
Ophthalmic
Solution) one
syringe of 1 ml
PFS containing
Sodium Sodium
Hyaluronate 14 mg
in 1 ml vials and
one syringe of 1 ml
PFS containing 24
mg
Sodium
Hyaluronate)
f000
COmわわacたs
Of one PFS of
cOrPra′
"′ng f4
“
g sodi“ m
Hya′uronare
and a"olher f
m′
PFS
containing
Sodium
Hyaluronate
24 mg
Sodium Hyaluronate
41.8gm
2.
Barrels(Hypak SCF 2.25 rnl RF
PRTC FM 27)
2000 Nos.
3.
Plunger Rod(Hypak PR 2.25 ml
PP) _____
2000 Nos.
4.
Plunger Stoppe「(Hypak BSCF
l-3 mlPH mlPH 701ノ50C BLK
S11000 WWD)
2000 Nos.
5.
Back Stop(BaCk Stop l-3ml PP
Clear)
2000 Nos.
6.
Blister(PP BliStЬ r 2 25 nnlノ3.0
mり ____
2000 Nos.
7.
Cannula (ComPonent for
Prefilled Syringe)
2000 Nos.
8.
-Tyyvek Lid (Packing Material)
(Packing material for Prefilled
Syringe)
2000 Nos.
|夕
|
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1312,2014-(hclnicnl
()/oTHE｀DEヽrE L()1)卜lE■t‐T COヽIヽlISSIOヽE It(ヽ:Sヽ1二)
(CHEヽ11(〕Al_1)IVIS10N)
'th llo6r.Aヽin■.Nil■11〔tn Bha、、
`a11.
Ne、、Delhi
Dateiノ3.31ay,2017
OF「IC'Eヽ4Eヽ4(DRANDOヽ4
Sutteす織:;;器tn占認l%:店iξttFl∫綿F詰1::in品させ戦
:li翻Flt]l
regarding.
No 01/82/162/29/AM16/DES―
|||ノ141 dated
DGFT ma, pleムse refё r to OM
0902261レ。f regarding amendmentin the expon description of Advance Authorization
(AA)No 0310776907dated0312014issuedtoMノs Makson lndust百es PVt Ltd ln the
Advance Authorisation under reference, the item of export has been desCribed as
421107K9of VICKS∨APORUB inthe PackS Of50 GMS」a rs,80 GMS ttubes and 100
GMS」ars
The request of amendment in the packing desCription tA/as exarllined lt iS
Obse「∨ed that O/O」t D(3FTヽυ4umbai has already amended the initia‖ y isSued A A the
、
ィith respect tO packing Of export descriptiOn to 5 GlvlS」
a rs.10(3MS Jars 25(3MS Jars,
託CMSぬ"d■
00■Sユ
耐
“
輌
y
・
y
criptionvuithrespectofpackingmaybealioweciinthe
nc「Ime fi)(ed against thO referred A AいノithOLit any change in import or export quantity
wastage anci inPut-outPut norms'
.Thisissueiswiththeapprovalofcompetentauthority.
Director (Chem.)
Shri Nirmal Kumar'
.
Dy. Director General Foreign Trad.e'
n]N". 307, O/o Director General of Foreign Trade'
M/o Commerce and lndustrY,
DES lll Section
一
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一
‐
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ly_
玉Ь一。た
F. No.350 11 117 1 1201 6-(Pl-Norms)
Government of lndia
Dated: January ,2018
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-20
case of M/s Fresenius Kabi Oncology Ltd.
The undersigned is directed to refer to DGFT U.O. No. 011821050/00788/AM-
17IDES-3/95 dated the 2711112017 vide which application from M/s Fresenius Kabi
Oncology Ltd. was sent to this Department for fixation of norms under para: 4.7 for the
export of Cytarbine injection 100m9/1ml, 500m9/5m1, & 1gm/10m1. 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: parveen. 1 9@gov.in
Email: sk.paniqrahi@nic. in
/
S.no.
lmport item
Norms recommended
1gm/10m1
500m9/5ml
100m9/1ml
1
Cytarabine white to off white crystalline
powder assav: NLT 99%
1.10gm
0.559m
0・119m
2
Rubber stoppers 1 3rnrn grey bromobutyl
6720GC
As per packing policy
3
Glass vials M clear 13mm T-1 5mlCA
07233
4
Glass vials 20mm T-110-ml CA 8706
5
Rubber stoppers 20rnrTn grey bromobutyl
6720 GC
/
|`′2,I〕
/
じ03
F. No.3S0 1 1 I AZtZ\,lZ-(pl-Norrns)
Governnrent of lndia
Minrstry of Chenric;rl & [::ertilizers
Departrnent of phar nrarceuticarls
llr:onr rrr:.1)10, B-wing, l]',r floor,
Jarrpath Bhalvan, New Delhi.
Datecl: Novernber ?_, 2017
O_ffice Me-ryorgn-dunl
Sull - Fixatiotr clf tttlttt.ts uncler para 4.7- Application of M/s Jubilant Generics Ltcl,
Noicla.
I-he rrndet'sigrtecl is clirec;teci to refr,:r to DGt-I tJ.o. No. 01/tJ2i0501008g0/AM-17/D[:S-
3/800 dated 28.12.'2016 vtcle which an application fronr M/s .lubilapt Generics L.tcJ. was
sent to this Departtrent for fixatiorr of norms agairrst export of Spirorrolactone 25 lng,
50 mg and 100 nrg Tablets. This <lep;rrtrrent has exarnirred the matter and flre
following norms for each of the 3 strengilrs are furnished as follows: -
Procluct to bo fxpoiiect
Raw il′ latol'iais to be lnllooFted
2
$pironolactone
25 mg Tablets
Spii'onotiiiorie
50 rrrg Tablets
QLtantit
S No
y
1000
Tablets
1000
Tablets
1
Spi「onolac()ne
Nlicrono::ecl
Description
Sprirorrolacorre
(Viqplqzqll)
Calc;rurn Siulfatc
Qrlryslielq_ -
Spironolacone
(lVlrqryrqrelr)
Calciurn Sr,rlfale
- 0lJa"iiiy--
- 2s.50-tr;;
103.25 gnl
51.00cJ:η
3
|
$pirorrolacton
100 nrg Tatblets
206.50 gm
102.00 gnl
413.00 gn3
QLttv.tt4e
2 )
This issLres with the approval of conrpetent autlrority.
til) _-
'*f[rt/t 1
(Parveen l(r-rrhar)
Llrrder Secretary to the Goverttment of lndia
Phone: 23352298
Eni a i l : B13IY39!.19@qPY Ul
Directorate General of Foreign TrarJe,
Department r:f Cclnttlterce,
Shri S.K. F'attig;rahi, Econotric Officer, DES-lll
tJdyo.cl Bhawan, New Dellri
[: r il a] I l. S k p--rtttgL atl!.@J"llq- i!-t
lタイ
器
2
1
plいyJ[oL___
100()
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一
一
一
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