DGFT Committee Minutes
Document text
Government of lndia Ministry of Commerce and Industry Directorate General of Foreign Trade Maulana Azad Road, New Delhi I l00l 1 Norms Committee-lll
Para 4.7 Decision
Meeting No. 0g/g2lz}li of zoli-lg dated 13.12.2017 considered the cases/issues under Duty
Exemptlon Scheme (Chapter-4) of Foreign Trade Policy,2015-20 pertaining to Chemical and Allied
produtts falling under cirapt"i zq and 3b, held on 13.12.2017 under the chairmanship of Shri J.v.
i'}atil, Addl. DGFT in Room No.04, Udyog Bhawan, New Delhi'
Following members were Present:-
Shri Nirmal Kumar, Dy. Director General of Foreign Trade
Shri Arun Kumar, Consultant, Department of Pharmaceuticals'
The committee went through the minutes of earlier meeting No. 07/82 dated 22.11.2017 and
approved the same.
Note:
In certain cases the decision of the Nornts Committee refers to the Recommendations/ Observations /
Deficiencies received from thi concerned Technicol auihority in the same case or a dffirent casg 9f
an"other firm with the same product. A scanned copy of such document is placed at the end of the
Minutes. In some cases, the scanned copy uploaded may be unsigned' In both thes-e instances' the
scanned copy uploaded is to be acceptei. The Commitiee does not approve SCOMET items and all
applicants are understood.
MEETING NUMBER : 8/82-ALC4I2O17 MEETING DATE :13.12.2017
iCase No.:2/2/85‐ ALC3/2012 ParりName:SAIRAM IMeet No/Date:8/82-
Status:
10RCANICS PVT LTD IALC4/2017
,Approved
|10 1113 1RLA File Lic.No/Date10910050555 1 :
101/85/050/00002/AM13/ :09/24/040/00452/AM12/ 130.12.2011 1 1
1Decision:The Committee decided to ratify norms based on the recommendation of D/ol
―
・ ^‐
‐ … ^― ^´ 力′"r"′ nハ4r nl′ へ:^___ヽ 劇^+^J つnd 、■ぅ、′ っ∩1^ |
rpharmaceuticals forwarded O.M. No3501,1,/757 12015-Pl(Norms) dated 2nd May, 20L6,
iuploaded at the end of these minutes or as applied by the firm whichever is less under
:piara 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC'
.Case No.:60/17/82‐
ALC4/2016
IHQ File
l:01/82/050/01021/AM17/
誂淋∬認)MFED
IRLA File
l:09/24/040/00021/AM14/
13.12.2017
IMect No/Date:8/82‐
lALC4/2017
113122017
IStatus:
I)eferred
ス
ツ
ー
‥
…
…
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‥
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一
IDeclslon:Deferred
1譜だり
Rtte:0910055945B鮨ち
4.01.20181
‐ ‐
― ‐
‐
‐ ´
‐ ‐ ~~
‐
‐
‐
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‐ ‐ -1
IMcet No/Date18/82‐ lStatus:
ヨ
13 1Case No.:40/1/82¨ ALC4/2017 Pa“ y NameiONEIRO
| IDecision:Deferred ne:NEWλELIANCEIMcetNo/D猛 tus: Deferred 113.12.2017 Defer Date:24.01.2017 l'oiriii6soroo622tuwrst intqqiqorcor2ztuwty 122.0s.2014 i I Decision : The Committee decided to ratify norms based on the recommendation of D/o pharmaceuticals forwarded O.M. No3501U5 48/20L4-Pl(Norms) dated April, 2015,t uploaded at the end of these minutes or as applied by the firm whichever is less under 1para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decilio-1of NC I 「P珈面 4/2014‐町面綱 1臨 耳蔦百 ~~需 鸞 ParりName:VENUS IREMEDIES LTD., IRLA File :22/24/040/00016/AM15/ 翻FF… ~甲誡 「 ~ 翻渕両臨蒜 ~ F印四I I IMcet No/Date:8/82- IALC4/2017 113.12.2017 ユ Deferred IHQ Flle IRLA File , ,Decision : Deferred lCase No. :5/1 7 182- ALC412016 iParty Name:SNF [INDIA] I IPVT. LrD., ド FHQFile No/1Date:8/82- ｄ Ｓ ｔ ａ ｔ ｕ ｓ ‥ ¨ IALC4/2017 113.12.2017 | :01/82/050/00966/AM17/ | 1眺ち刷:oЮoo鯰/AMИィ 16 F辮鸞而」 Decision : Deferred No/Date:8/82‐ IALC4/2017 113.12.2017 ,Deferred F暇¨ソ望懸 ` IRLA File i:09/24/040/00108/AM15/ i iDecision : Deferred Status: Deferred
RLA File l:01/82/0s0/0t2t7lAMls/ l:03/941040/00386/AMls/ | IDecision:Deferred | .Casc No。:42/15/82‐ | ‐ALC4/2014 111霞璽肇二妻彙 F正三 Pa●y Name:ABEERS ,Meet No/Date:8/82- Status: IPHARMACEUTICALS PVT IALC4/2017 1LTD 13.12.2017 騰ち酬 ioЮo葛Imy~開漱需面面砺嚇江扁嘉y Decision : Deferred | ICasc No。:198/5/82¨ ParりName:SHASUN PHARMACEUTICALS IMeet No/Date:8/82- IALC4/2017 113.122017 PttdII LIMITED RLA RL |:04/24/040/00205/AM15/ rDecision : Deferred Paty Name:ABEERS Meet No/Date:8/82- in/nate・R/R,_ ‐ St: Status: IPHARMACEUTICALS PVT ILTD IALC4/2017 113.12.2017 IDeferred RLA File 105/23/040/00360/AM15/ ILic.No/Date:05103920H IDefer 14.H2014 1Date:24.01.2018 [-ic".. Nrtszl8/8r:--iP"^, N";.,ABiERS --_[\4;;iNi/D"t.'3/8]-- " ',ttl;ctzou iruanuacnurlcAls PVT IALC4/2017 irs i'--- --- lr-ro irt.tz.zott i'- i- --n---:*-..
- r.--' i iHO ril. -- -- r,in rir. - lLic.NolDate:0510392368 I l:01/82l0s0/01448/AMls/ l:05t23t040/00413/AMls/ lt0'1220r4 Status: Deferred 一 | | 田源百五y フ Lic.No/Date:0310787982 1Defer 12.08.2014 IDate:2401.2017 ICase No.:217/13/82‐ IALC4/2014 IPaty Name:ENCUBE IETHICALS PVT LTD IMcet No/Date:8/82- IALC4/2017 113.12.2017 ,Status: Approved |.^1器星泥 5υ022υAMly RLA File l:03/94/040/00494/AM15/ Lic.No/Date:0310788620 102.09.2014 101・ ~… ~~~~― ■■ _ lDecision : The Committee decided to ratify norms based on the recommendation of D/o i lph.rr.."rticals forwarded O.M. No35OLtl783l2015-Pl(Norms) dated 14th Juty, 2016,i luploaded at the end of these minutes or as applied bythe firm whichever is less underl lpara 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. I P冨りName:PVS AGRO VET IMeetNo/Date:8/82‐ 1借″盤了 iStatus: 109/24/040/00246/AM15/ 16.102014 ‐Case No.:111/13/82- ALC4/2014 11210iぉ :01/82/050/01114/AM15/ ICase No.:65/15/82¨ ‐ALC4/2014 14 HQ File i Decision : Deferred J
II》ecision:】Deferred
――― ――¬
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stati画面薦
|
' I
i13.12.2017
:
,
HQ File
IRLA File
rlic.No/Date:0910061483 Defer
,
rDecision : The Committee decided to call for information based on the recommendation,
tof D/o Pharmaceuticals forwarded O.M. No35O77|OL/2O15-P|(Norms) dated 0L.06.2016, i
iuploaded at the end of these minutes and deferred the case.
‐Case No.:149/5/82¨
| IALC4/2015
IPa●y Name:ALCHEMIE :Mcet No/Date:8/82- Status:
LABORATORIES
:ALC4/2017
Deferred
,Case No。:112/5/82‐
IALC4/2015
,HQ Filc
:01/82/050/00252/AM16/
ParサName:UNIMAX
ICHEMICALS PVT LTD.
RLA File
103/95/040/00812/AM15/
lM86tヽも,5貌
`itた'1~
:ALC4/2017
113.12.2017
:Status:
iDeferred
ILic.No/Date:0310793039 1Defer
IDate:24.01.2018:
191責O ri18
‐
| :01/82/050/00228/AM16/
1 1Decision:Deferred
IPHARMACEUTICALS PVT ,ALC4/2017
1LTD 13 12.2017
1RLA File lLic.No/Date:0510392949
1:05/23/040/00486/AM15/ 121012015
119・01・2015
IDecision:Thc commitee obseⅣed that CA cenincate imished by the■
111l in twol
,appliCttions renects contradictory production and consumption dtta for the year 2013-14.|
:Furthcr ITCHS code of import and cxport product also needs to be corrccted.Ani
:inVeStigation in the matter is under process.The Committee accordingly decided tol
'deferred the case.
Vきま湿高品よ聯藤「…
IALC4/2017
,13.12.2017
Pa=y Name:SHREE GANESH
REMEDIES PVT.LTD.
'status:
iDeferred
|~IRLA Fne
―=二
|
:34/24/040/00295/AM15/
:Lic.No/Date:3410040965
'16.02.2015
IDefer~~~…
IDate:24.01.2018
Decision: Deferred
い
|
iCase No.:61/17/82‐
IALC4/2016
1HQ File
:01/82/050/01022/AM17/
Paty Name:MYLAN
ILABORATORIES LIMITED
IRLA File
:09/24/040/00607/AM15/
IMcet No/Date:8/82-
'ALC4/2017
.13.12.2017
1Lic No/1Date:0910061652
12602.2015
し
1
P釘サName:SUVEN LIFE
SCIENCES LIMITED
|
Decision: Deferred
]
Case No。:447/5/82‐
PTりName:AARTI
Mcet No/Date:8/82‐
INDUSTШ ES ЫM「ED I什
%賀F
IЮ 1/82/050/00587/AM16/ 1Ю 3/94/040/OH31/AM15/
ILic.No/Date:0310794543
112.03.2015
IЮ 1/82/050/00587/AMiO/ 1:Uj/ソ4/U4U/Ullj1/AMIDノ 1lZ.U'・Zυ
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lDecision : Deferred
|:01慇2/050/00119/AM16/ 1:09/24/040Ю 0652/AMI■_ 1191791f_ ____P'マ191`VIサ
|
IDecision:The COmmktee decided to deferred the case and refer to Blo―
technology fori
itheir comments. __ _ _ _｀
三
11従淵1∫α
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l l : 113.122017 . :
14器星児
5υ007HttMlα ttλ ttiOЮ0812ハMly 拮ど
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03107946123鳶ち
4Ю L2018:
1 1bι tiξiol i十ハととも品占
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翻F薦師戸
|
RLA File
Lic'No/Date:0910061882 Defer
HQ File
RLA File
!lt^)o^
Decision : The Committee decided to deferred the case and refer to Bio-technology for:
Pa“y Name:NATIONAL
一
ゝ
| ,Case No。:65/4/82-ALC4/2015 Paty Name:MYLAN
I I ILABORATORIES LIMITED
?51責Oiぉ ヽLA hお ~
: 101/82/050/00104/AM16/ :09/24/040/00662/AM15/
1 1Decision:Deferred
M編駈y聞孵繭~…
:濡詰~圏
γ 蒟面821
Decision: Deferred
1281Case No.:129/7/82‐
IMeet No/Date:8/82‐
⌒
IPTりName:LANTECH
IPHARMACEUTICALS LTD ALC4/2017
. 13.12.2017
ｄ
Ｓ
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ａ
ｔ
ｕ
ｓ
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¨
P2爾蕩鷲~~~~~
tRLA File
B鮨ち
4.01.20181
::01/82/050/00111/AM16/
104.03.2015
Decision : Deferred
HQ File
,Status:
rDeferred
う
Ｚ
IMcet No/1)atc:8/82-
1鵬d
ILic.No/Date:0910061843 1Defer
:31.03.2015
,Status:
IDeferred
IDate:24.01.20181
‐ ' I
「
西壷万う
b15
IHQ File
l:01/82/050/00734/AM16/
ITUBE INDUSTRIES,
IRLA File
l:03/95/040/00073/AM16/
ILic.No/Date:0310795930
114.05.2015
P山離dII
IDate:24.01.20 181
主量
|
J
「
301責O ri18
‐‐
~
| :01/82/050/00715/AM16/
I lDecision : Deferred
J
IINDUSTRIES LTD.,
IStatus:
:Deferred
lDefer
iDate:24.01.2018
| ICase No.:60/4/82‐ ALC4/201`IPa“ y Name:ADCOCK
: 1 lINGRAM LTD,
1 1 ,
IT¨…Кψ噺下Ⅷぽ∝
132■0116~~ ~IRLA由に
1 101/82/050/00123/AM17/ 1:07/24/040/00071/AM16/
1_1'II:誕範
Й
ttr___
ILic.No/Date:0710108351
110.06.2015
Status:
rDeferred
'Defer
Date:24.01.2018
Decision : Deferred
i-lC;;Nr:r4l13/82-" - - ipu.tvNurn"*nrNrl-rFE--iM*tl{./b;t"fni:-* [statusi
i
i l;;aii;oii
iscrENces LrMrrED. il!?:t?:.tl
lDererred
I
I r
1
ir3.12.2017
i
I
133 no rl"
- rRLi File
-il-i..Norout.'oqlb062r!s io"r.t - - --
1
I i,ffi;[r orco6s2/Av,t7t \,ieliiioioro0034/AMr6/ iio.oC:oLi
]Date:24.01.20r8 |
, ,Decision : Deferred
ase No。:48/19/82¨
再
Ｆ
1漱鳥無熱~ ~辻
:璃摯よЙ夕‐
iPHARMACY 113.12.2017
1RLAiお
~…
‐ ~i〕
し｀も/D滸もう41oo■14」
|:24/24/040/00007/AM16/ 115.062015
LC4/2015
乙
1徴
"盤
了
ICase No.:17/7/82-ALC4/2015
IHQ File
IRLA File
:ALC4/2017
:13.12.2017
l:01/82/050/0 06221 AMl6l
::051241040100078/AM I 6/
IHQ File
: IDecision:Deferred
Ｆ
‐
‐
３
５
‐
‐
,Case No。:41/13/82-
:ALC4/2015
IHQ File
l:01/82/050/01004/AM16/
Pa●y Name:DANOPHARM
CHEMICALS PRIVATE LTD.
Mect No/Date:8/82-
IALC4/2017
13.12.2017
:Status:
Deferred
剛ittII話葛
Lic.No/Dtte:0310796667 1Defer
16.06.2015 1Date:24.012018
IDecisttFTbお轟丼Li
一
iCase No.:50/8/82-ALC4/2015 1Parり
Name:PUSILIN IMcet No/Date:8/82‐ Status: |
| IBIOTECHNOLOGY IALC4/2017 1Deferred l
l PVT.LTD. 13.12.2017 1 :
36 HQ File~~~~~
|:01/82/050/00846/AM16/
1認鼎α剛00381"B誰ち
4劇2∝8
RLA Fi18~~ ~
¨
:06/24/040/00014/AM16/
IDecision:Deferred
|
| |:01/82/050/OH90/AM16/ 1:09/24/040/00524/AM15/ 115.07.2015 1Dtte:24.01.2018
1扇
¨
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―
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而統~1事
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I Decis
ICase No.:20/16/82‐
IALC4/2015
Pa,y Name:MYLAN
LABORATORIES LIMITED
7
IHQ File
i:01/82/050/01340/AM16/
Lic.No/Date:0910062338 1Detr
B鳶ち
4.01.20181
IRLA File
115.07.2015
離盤i:[卵W姓棚ναν紗
~
1 113.12.2017
RLA File
103/94/040/00282/AM16/
1悧器α∝Ю""“
iDecision: Deferred
lCase No.:115/13/82-
', ,X,CltzDts
竃
]器営器¶賓YENTA
lMeet No/Date:8/82-
IALC4/2017
113.12.2017
1剛ed
"| |
IRLA File
, Lic.No/Date :03 107 97 627 iDefer
i:03194fia0fi0038/AMl6/ 124.07.2015
l iЧ9ユ
1,
iDate:24.01.2018
r
|,Iζ
8Nよ蒲たた
':ALё
420151m淑
柵
CARE I造き淵
αν82¨
1総
led
l l ,INDIA LIMITED 113.12.2017 1
42:HQ「品 ~ I::_■
A141111■1111:|~ⅢⅢⅢⅢ
6SibbうSi02 2:虫111二:
Decision : The Committee decided to call for information based on the recommendation
I lof D/o pharmaceuticals forwarded O.M. No35OL1/76712015-Pl(Norms) dated December,
?0L7 un]o3ded al the end of these minutes and deferred the case.
||五ζ8Nよ蒲たたう:ALC4たdi5 Pan｀iおよREё d青
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巌
~~~|
|'oiltz7osolo0869/AMl6/|:o5Dafia0loo2l3/AMl6ll,'.o,.?o,'lM
lDecision: Deferred
J
…
一
一
一
一
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一
一
一
一
一
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鷹
41、/ うo o8 2015 1Date:24.01.2018ィ
:肺品掲5υO Ю8吸M10
おら4/bЙ υ0087りAMly "0&2015 pttα
240L2018:
IDecision:The Commtttee decided to deferred the case and refer to DIPP Chemicals forl
ltheir cornrnents. ,
:
::01/82/050/00298/AM17/
IDecision:Deferred
IRLA File
::03/94/040/00424/AM16/
「 F彎聖Ⅲ型響‖i些劇
聞鷲 |
g
E霊詰騰釜
[鴨D"
lDeferred
I
浄3日函稲
「
‐~
:碗λ刷,0/00878/AM15/
Lic.No/Date:0310798205 1Defer
1 1:01/82/050/01090/AM16/
11■0&2∝5
iDate:24.01.2018l
t!
iDecision : Deferred
1辞罵ψ般‐
| IALC4/2015
||
148温
|:L::1響γ
,eurry Nur"'neiHBn
'Meet No/Date:8182- rSta-tus: .
inrousrrups LIMITED lttcqnon
lDeferred
1-'"""
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I
罵蕊蔦
~~話
奮犯F万而41630隔∝剛]
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――一―一日蔚ilc
O/01293/AM16/ 1:52/24/040
――
――――二―――
___=_―――――――――――一――――――――――――――――一―――――――――――――――
「
|
I
_t
;Case No.: l l 8ll4l82-
eatty Name:SHASLTN lMeet No/Date:8182- 'Status:
.ALC4/20I5
PHARMACEUTICALS ALC4I}OI'I
'DEfCTTEd
LIMITED
13-12.2017
I鳥蕊誌瓦I話葛
~~脇
蔦蕊蕊百~閉
盟
'Tma“
5臨綱五1国
IDecision:The Commtttee dedded tO Ca‖
fOr informa■on baSed on the reCOmmendation
ツeu瀕0■:mにしuⅢ… CG uSuu… … ……… … …… …‐
}円仰Orm→dated hnら2016:
lof D/o Pharmaceuticals forwarded O.M.No35011/776/201:
uploaded at the end of these minutes and deferred the case.
the norms for the
100% cotton
ICase No.:79/14/82‐
IALC4/2015
iParty Name:ABEERS
]PHARMACEUTICALS PVT
iLTD
1倍敦盤ソ
圏
‐面面孫
‐
HQ File
.:01/82/050/01215/AM16/
IDecision:Deferred
1眺ち酬:0/00274/AM16/
| ICase No.:164/14/82-
I ALC4/2015
1521責Q Fll`
. 101/82/050/01300/Aヽ416/
Paty Namc:AASHA
‐BloCHEM
IRLA File
:10/24/040/00049/AM16/
iili.ir, t D.ierred
|
lStatus:
「
を
1:きヽ
「
:力′
16/§
'「
~~… …
11五お｀:h`LACT6SЁ
:ALC4/2015 '(INDlA)LTD.,
IALC4/2017 1Deferred
'13.12.2017 1
猪躍|:VTII疑二九
531■O rilc
101/82/050/01397/AM16/
1 :Decision:Deferred
話断諾翻おly高互
I
|
9
|
| ICase No.:86/14/82¨
,お｀:轟8:BELiか良Ё立正良:Ⅲ馨ⅢⅢα炒82‐
Status:
i
Approved
l
| IALC4/2015
:鶴説躍∬器AM I倍け鰍v
:Lic.No/Date:3510044794 1Defer i
::3 5 l24l 040 I 00005/AM I 6/
125.09.2015 1Datei24.01.2018‐
1尋高品爵漸轟鳥
i温覇嘉ま
age ttm等ほ
ke necessary action as per the
|
:巨菖:高『｀
C・
:Status: :
:Deferred i
No/Date:8/82¨
1造棚ッαν
82‐
113.12.2017
日｀3扇面410161132
20。10.2015
## Case No.:136/14/82‐
‐ lALC4/2015
甲
爾‖翻泌町
|
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1
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|
ｎ
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ｐ
ａ
Decision : The Committee decided to ratify norms based on the recommendation of D/o
Pharmaceuticals forwarded O.M.No35011/764/2015-PI(Norms)dated November′
2017′
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.
「
い
面i所扇I
IALC4/2015
56圧
=ム
「ご覇1~~~~
臨蕊i繹
Paty Name:VINS
BIOPRODUCTS LTD.,
Mcet No/Date:8/82‐
ALC4/2017
13.12.2017
03.11.2015
|
IRLA File
109/24/040/00442/AM16/
ALC4/2017
Status:
Deferred
囲肝画面薫
k:~
‐Case No.:2/1/82‐ALC1/2016
IMeet No/Date:8/82-
‐ALC4/2017
13.122017
:01/82/050/01776/AM16/
591011も
‐ ~
:01/82/050/01779/AM16/
IMeet No/Date:8/82-
:ALC4/2017
:13.12.2017
Decision : Deferred
IQ
iCase No.:116/13/82‐
IALC4/2016
luq rite
l:0 | t 821 050 / 007 44 / AMt 7 I
―
―
―
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彙
IHQ File RLA File lLic.No/Date1051 0396670
101/82/050/01517/AM16/ 105/24/040/00439/AM16/ 118.122015
## Case No.:23l19/82-
Party Name:FRESENIUS Meet No/Date:8/82- Status:
"lrcuzlts
rfirt,r?il.olocY ,ii?:::rrl
,Approved
HQFileRLAFileLic.No/Date:0510397138
-,:011821050/01503/AMl6l :0512310401002601AM161 .30'12'2015
62
l--:necision : The Committee decided to ratify norms based on the recommendation of D/o
, ipharmaceuticals forwarded O.M. No35OL1,l87Ol20L5-Pl(Norms) dated November, 20L7,
: iuploaded at the end of these minutes or as applied by the firm whichever is less under
r rpara 4.O7 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.
,20]:6 uploaded at the end of these minutes and deferred the case.
|
「た黒責めiカニ~ ■●ヽと
hまÅ走｀
LttЁ ‐
出嵐摯よな
たダ 識1
1 1ALC4/2015 SCIENCES LIMITEI
l l l 113.12.2017 1
:3鶏諺月:liふ」法話j~場
ら濡il話illll:せ
ざ:串111111111撃九|=
1 1Decision:The Committee decided to callforinformation based on the recommendation
l of D/o Pharmaceuticals forwarded O.M.No35011/217/2016-PI(Norms)dated October′
|~ica品ヽ二洗万/82-ALdi力di`,蒟雨
`“
8tiEXPORTS
雉き淵
αν82-
暇
ed I
1 1 lPVTo LTD.,
「|,ぁi轟ぃ|:1轟輩品二こ|1新揃:響:犠箋れ
11
1 lDecision:Deferred
i l __
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‐ ~~
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, ,'oilaiiis6/g1840/AMl6/ |:0319ry040100831/AMl6/ 18.01.2016
loate:z+'gt'z0ts
, ,Oecision : Deferred
iDecision: Deferred
I FaseNo■
22/19/12‐ALC4ノ201511】
1き
Namα FRESENIUS IMeet Nσ L々
、BI ONCOLOGY LIMITED IALC4/2017
13.12.2017
〔
HQ File
Decision : The Committee decided to ratify norms based on the recommendation of Dlo
Ph arm aceuticals forwarded O. M. No35 OLL I 87 O /2015-P I (Norms) d ated Novem ber, 2O!7,'
uploaded at the end of these minutes or as applied by the firm whichever is less under
lpara 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.
I
IRLA File
:05/23/040/00244/AM16/
Lic.No/Date:0510397137
130.12.2015
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'Meet No/Date:8/82¨
Status:
IALC4/2017 1Deferred
113.12.2017 1
:Lic.No/Date:2210015407 1Defer
0102.2016 1Date:24.01.2018
:Decision:Deferred
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「¨ 壺―
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016 :Date:24.01.2018
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1 1 113.12.2017 1 1
庶脚器1惚諄
| lharrna fortheir examinttion and comments. _ __ :
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| ,Case No.:69/1/82-ALC1/20161Paiy Name:ENCUBE
: 1 1ETHICALS PVT LTD
||F臨:=蔦百
『
~~
t :03 I 9 4 I 040 I 009221 ANII 6 I
i lDecision : Deferred
I ,Decision : The Committee decided to call for information based on the recommendation I
', ',of D/o Pharmaceuticals forwarded O.M. No35OlLlt38l2016-Pl(Norms) dated August,
「 lbitt NI:七o/2'82:ALこ4/26it l島ヽ五五ЪllANЁ ttA
731鵠虚月
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IDecision:Deferred
ICase No.:6`/4/82-
IALC4/2016
ら
41器星掲
5υ0012りAM17
IBIOTEC PVT.LTD.
|
|~醍
麓蔦面高蔦
;蔦「
…
Pa“y Name:STRIDES
SHASLIN LIMITED
IRLA File
i04/24/040/00257/AM16/
:ALC4/2017
lDeferred
113122017 1
Lic.No/Date:0510397827 Defer .
104.032016 :Date:24.01.20181
|
1鼈:』肝琴
tC8/82‐
113.12.2017
Status:
Deferred
‐
ti:ヽ6′b晟よ
bイibigit85~ib`ふ
‐ '~
104.03.2016 :Date:24.01.2018
露」補暴鰭捕羅悧珊]鮮丑璽Ⅷ∬里
\ALC4l2017
脇蕊蕊萩蔦
ICaseNo。:3/2/82-ALC4/2016
|
1771責O Fiiき
|:01/82/050/00003/AM17/
1瓦3面蒜befe二|もa
ParりName:RONAK
ICHEMICALS
IRLA File
l:34/24/040/00329/AM16/
IMeet No/Date:8/82- iStatus:
苺Ⅲ
…… |ふtd
t3.12.2017
l-"-.'"-'-
"-'-*'
ilic.No/Date:34 I 004 1 957 iDefer
109.03.2016
IDate:24.01.2018
178
iCase No.:100/7/82‐
IALC4/2016
1HQ Flle
Party NameiCATAPHARMA
,CHEMICALS PVT.LTD.,
iMcet No/Date:8/82-
:ALC4/2017
:13.12.2017
1Lic.No/Date:3110066051
Status:
rDeferred
|
げ
IDefer
―
l
iCase No.:67/4/82-
lALC4/2016
Paty Name:STRIDES
SHASUN LIMITED
２
８
一
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1剛ed
|
}51器島児
|:04/24/040/00256/AM16/
104.03.2016
1鷺潜鶴非翼器∬
i事糖Tl:]墨墨■
TttitttλξⅧ∬鷲ま
:ll
'i2OL6 uploaded at the end of these minutes and deferred the case.
1鵠淵ξ騨♀器
lStatus:
,Deferred
HQ File
:01/82/050/00118/AM17/
B誰ち
4.01.20181
IRLA File
画面面而涵面蔚戸
~籐
聯83/04
Decision : Deferred
E驚柵謡甜諄乳TD輝ゴげ
Dttαν' ,江
u∬ |
| 113.121獄ザ
FeLrrel _壼
,Paty Name:AARTI
IINDUSTRIES LIMITED
IRLA File
|:03/94/040/01108/AM16/ …
剛W5西1濡瓦葛
J
I 1 1
‐Case No.:138/7/82¨
:ALC4/2016
:Party Name:ALTA
ILABORATORIES LTD.
IMeet No/Date18/82- IStatus:
IALC4/2017 1Deferred
113.12.2017 1
Lおヽも
'b表`bjib恵
6」70ケ:bもfef…
…
101.04.2016 ,Date:24.01.2018
181
|
IPaりName:AARTl lMeet No/Date18/8
Tヽ1ヽlTOTDI口
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T rz1/,o17
Meet No/Date18/82-
IINDUSTRIES LIMITED
ALC4/2017
:`八
″
V'′
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113.12.2017
,Status:
,Deferred
iRLtFil" -
--[i..N"/D"t"o3l08038ltlo.f"a--'.
l:$Dafia0t0l038/AM16/ loo.o+.zoto
lD",:21'0:20L8"
iCase No.:45/7ノ82-
lALC4/2016
Paty Name:ASTRAL
ISTERITECH PVT.LTD
,HQ File iRLA File
li01/82/050/00219/AM17/ 1:34/24/040/00009/AM17/
関蒻I需響
~爾
殴:跳ν
l bl
1851CaseNo.:7/6/8:「,キ:1:illl
ヘ
14.03.2016
F9焉3既蔦議荻蔦
Decision: Deferred
ICase No.:43/4/82‐
:ALC4/2016
澤0“ 由g~~
:01/82/050/00106/AM17/
lRLe pite
t:03 I 9 4 I 040 I 0 I 1 12 I AMI 6 I
|:01/82/050/00312/AM17/
L21
IALC4/2017
113.12.2017
lDeferred
寵需m∞″“
48誰ち
4劇川8:
IMcet No/Date:8/82-
IALC4/2017
:13.12.2017
―
一
―
一
一
一
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一
一
一
i lDecision : Deferred
122.04.2016
國責蒟むЙ百更F71疋汀65wAL=FⅢ2.21口二II
IRLA File Lic.No/Date:0310804365
103/95/040/00013/AM17/ 103052016
|
―
「
1器3泥590m7″AM17
ICase No.:174/10/82¨
ALC4/2016
IPatty NameiFRESENIUS
‐KABI ONCOLOGY
ILIMITED
IRLA File
l:05/23/040/00038/AM17/
IMcet No/Date:8/82‐
IALC4/2017
11312.2017
1Lic.No/Date:0510398377
104.05.2016
Status:
I)eferred
lDefer
861責O Fii` ~ ~
1 101/82/050/00520/AM17/
1 :Decision:Deferred
――
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[馘嶽藩添雷S~~
1
iCase No.:9/7/82-ALC4/2016
|
IParりName:STRIDES
iSHASUN LIMITED
|
Meet No/Date苺/82-
IALC4/2017
113.12.2017
IMcet No/Date:8/82-
IALC4/2017
113.12.2017
Status:
'Deferred
―
|
―――――――一―
|
RLA File
Lic'NoiDate:0410161871 Defer
,
rHQ File
188 r:0t/82105 OlOOl82lAMlll ':041241040100009/AMl7/ 05'05'2016
lDate:24'01'2018
"" :"". ."" ;'^
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3Lcisi311‐ 十百
[こ8キlIIltiさ
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さと
|`La t6~tali f。linformation based On the recornrnendation
'of D/o PharmaceutiCals forwarded O.M.No35011/154/2016‐
PI(Norms)dated September′
19稀既:鳳|::/Am7 .監ち刷
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ibed i3と:||161 1Af。1lη atigスも
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rさL8丼ヽ
|lendationl
l lofD/o PharmaceutiCals forwarded O.M.No35011/154/2016-Pl(Norms)dated September′
|
| 12016 uploaded atthe end ofthese rninutes and deferred the Case. |
iS
rtaiei Nolo ate:8182- Status:
Party Name:FRESENIt
lrzapr oNaor.ocY
:ALC4lzOl7
lApproved
titrLC420t6
;rast oNCoLoGY il!?:'::,t:
i
I ILII二_____猿MITED 113.12.2017 1
了=電=~~~…………… ― ‐
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輛輛輔扁~硼鸞蕊1話1霊鱚
面雨「……
哺揮
IIl揃ゴ鮮選輔i軌:ま‖瀞:常ヽ金需′
“
]as under:
lFor 300mg injection (50m1):-
|タ
Date:2401.2018
Export ltem
S,No.
lmport ltem
Norms
Recommended for
1000 iniections
Paclitaxel Injection
of 300mg/50m1
1.
Ko‖ iphor ELP.
26.5kg.
2.
Ethanol Anhydrous
24.87Ltr.
3.
Silica Gel.
6.3kg.
4.
Cerrous Chloride
31.5gms
5.
(4S,5R)-2-(4-methoxy phenyl)-N-
Benzoyl-4-phenyl-oxazolid ine-5-
carboxlic acid
3.528kg
6.
Taxus Baccatta Leave
542.4kg
ア.
Rubber stopper for Pharmaceutical
Articles Use 20mm ttEF 2 1888 GRY
SIL LEV3 WESttAR RS OR Rubber
stoppers for Pharmaceutical
Articles Use WPS S10-F451
4432/50G B240 WESTARRS/SP06
As per packing
policy
8.
Glass Bottles Antibiotique 50, Clear
Glass Type t, Neck Finish
15083620200 Moulded Glass
Bottle 50ml Capacity.
As per packing
policy
RA concerned may take necessary action as per decision of NC.
| む:“ヽも
:ti七ウカ/82‐
~~ ~‐
| IALC4/2016
1 1責0■118 ~
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:91:o1/82/050/00331/AM17/
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IALC4/2017
113.12.2017
RLA File
:03/94/040/00122/AM17/
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'Case No.:86/11ノ
82- IParりName:ALMELO
IALC4/2016 1PRIVATE LIMITED
I I
File
/82/050/00620/AM17/
IRLA Flle
l:09/24/040/00056/AM17/
Decision : Deferred
／
タ
:Date:24.01.20181
瞥湘熙師欄構:榊1悩駐罫暇
『
~爾
薮
T:8/82‐ 謬蕗~~
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・B島4‐劉
8
ICase No.:149/10/82-
ALC4/2016
1附
Nttα ЫOLOαCAL E
'Mcet No/Date:8/82‐
IALC4/2017
113.12.2017
|
IRLA File
l:09/24/040/00546/AM16/
Lic.No/Date:0910063659
119.05.2016
Deferred
I rDecision : The Committee decided to callfor information based on the recommendation I
of D/o Pharmaceuticals forwarded O.M.No350LtlL45/2016-Pl(Norms) dated July, 2016
uploaded at the end of these minutes and deferred the case.
「 ~「 平~ 悪
IHQ File lRLA File Lic.No/Date:0310804944
981o1/82/050/00308/AM17/ 1:03/95/040/00069/AM17/ 124.05.2016
:
一
―
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一
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1
Meet No/Date:8/82-
lALC4/2017
113.12.2017
′
'
96 ,HQ File
ICase No.:83/11/82-
ALC4/2016
Pa●y Name:BIOLOGICAL E IMcet No/Date:8/82‐
IALC4/2017
i13.12.2017
1)eferred
197簿OFile
IRLA File
1冨鼎α
"Ю“
%∬
B鳶ち
4劇2∝81
j i:01/82l0sOtOO6t7lAMrr7l
i iDecision: Deferred
,0「霊淵郷か
Pa=y Name:FRESENIUS
iKABI ONCOLOGY
ILIMITED
HQ File
鵬島児
50Ю“
58/Am7~賠λ鵬
OЮ∞
%ハⅣ
11)ecision:I)eferred
靡諄‖銀町
~
=万
~爾
齋戸面雨
BttL4劇.狙8
一
‐
０
２
## Case No.:134/10/82¨
IALC4/2016
Decision : Oeferred
ParりName:ALPHAMED
FORMULATIONS P LTD.
|
1 下
~πARL ~~~
|:09/24/040/00087/AM17/
一
‐
０
３
## Case No.:121/10/82‐ ParりNamc:OPTIMUS Meet No/Date:8/82- Status:
ALC4/2016 1DRUGS PRIVATE LIMITED IALC4/2017 1DeFerred
, 113.12.2017 .
.HQ File RLA File Lic.No/Date:0910063765 1Defcr
:01/82/050/00467/AM17/ 109/24/040/00032/AM17/ 10806.2016 ‐Date:24.012018
1Decision : 丁he Cornrnittee decided to ca‖ for information based on the
lrecommendation of D/o Pharmaceuticals forwarded O.M.No35011/221/2016-P:(Norms)
ldated 12th September′
2017 up10aded at the end of these minutes and deferred the
‐case.
~「MP「~^
Ю4剛蔦靡
;
Partv Name:INCHEM
LABORATORIES PRIVATE
LIMITED
I蕊;
Decision : Deferred
|
## Case No.:61/11/82-
105 1HQ File
101/82/050/00595/AM17/
rDecision : Deferred
離濡評琵
|
IRLA File
109/24/040/00017/AM17/
臨
:
爾
1器星児
50Ю035νAM17~開:OЮ0043ハMW
一
２
．
孫:赫
0415162034
110062∝6
|′
lDate:24.0 I .201 8
‐Decision:Deferred
:~~
ゥ吻Nふも:A針琵
「
~… …
lMeetNo/Date:8/82- IStatu∬
LIFESCIENCES LTD., ,ALC4/2017 :Deferred
l 113122017 1
:RLA File iLic.No/Date:0310805494 1Defer
l:03/94/040/00132/AM17/ 115.06.2016 Date:24.01.2018
|
1081責
O rilさ
:.ハ1′ oぅ′^
Ｈ
Ｑ
側
一
Ｄ
ｅ
‐
1/82/050/00371/AM17/
Decision: Deferred
lParty Name:RECKITT
IBENCKISER(INDIA)
IPRIVATE LIMITED,
IRLA File
|:05/24/040/00128/AM17/
語出Ь
面呼MI
|
ICase No.:29/10/82‐
IALC4/2016
::壺濡
16/82‐
~1祓
濡需よ誉辮
ま血″IⅢ■
1lH 10●お IRLAhお ~~●し｀
6/Diま60ib6`3j161Defer~~■
1 101/82/050/00850/AM17/ :09/24/040/00128/AM17/ 2106.2016 1Date:24.01.2018:
| IDecision:Deferred i
―‐ ―― ― ― ‐― ― ―‐ ‐ ‐ |― __ =___
●__ ___■_ じ
## Case No.:78/10/82‐
ALC4/2016
FHQFile‐ ………~ ~~
|:01/82/050/00424/AM17/
IRLA File
l:B/2afia)fioo}slAM17l
囲嗣面
0482958涵高:
闇鮮
F/82-丁
lStatus:
lDeferred
lDecisio11■落肩話勇
1甲・η17917 i
Ｆ
Ｉ
１
１
１
１
;party Name:frfOnepEN -ifrf..iNolout.*ltZ- *
lstatusl"
lLaeoRAroRIES LTD., iALC4t20t7
lApproved
II
ltz D )o17
,
|タ
|
|
1107
ICase No.:14/10/82-
IALC4/2016
1lυ
′HQ File
:01/82/050/00360/AM17/
F祠品躙M檸‖…
File
i
iDecision: Deferred
' ICase No.:23/10ノ
82‐
: IALC4/2016
1 1
IЮ9 HQFile
: IDecision:Deferred
IMeet No/Datc:8/82- lStatus:
IALC4/2017
113.12.2017
:Parw Name:AARTI
IMeet No/Date:8/82¨
IALC4/2017
113.12.2017
Istatus:
IDeferred
IHQ File
IRLA File
Lic.No/Date:0310805623
121.06.2016
:01/82/050/00375/AM17/
,
| |
隔馘戸蹴哩里Lh l~
―
: The Committee decided to ratify norms based on the recommendation of
D/o Pharmaceuticals forwarded o.M. No35OtL/25312016-Pl(Norms)dated December,
2OL7 ,uploaded at the end of these minutes or as applied by the firm whichever is less
irra"r o.r. 4.e7 of HBp Vol.l. RA concerned may take necessary action as per decision
i
iof Nc.
iP@
ILASORATORIES PVT LTD.
i
I
lru-a pit.
\:}9DafiaYoots4lAMt7l 頸醜¨
師
「 Decision : Deferred
Case No.:39/10/82-
Party Name:ORBIT LIFE Meet NoiDate:8r'82- Status: , ,iiiuzoire scrENCE PVr LrD. ii?:::il Approved , Lic'No/Date:03 I 0805747 Defer I uq nile RLA File !1"^)o]Luj",ur ruouJ /+ / :011821050/00385/AMl7/ ':03l95l04ol0o235lAMlzl 28.06.2016 'Date:24 0l 2018l ll7 Decision: the Committee decided to ratify norms based on the recommendation of; , Dlo pharmaceuticals forwarded o.M. No35011/2 25l2oL6-Pl(Norms) dated 12th i I ,september, 2077, uploaded at the end of these minutes or as applied by the firm i whichever is less under para 4.07 of HBP Vol.l. RA concerned may take necessary 1 I I whichever is less under Pat , action as Per decision of NC. d冊 叫 KA COl田 … 岬 … … 叫 | ″ 1器島児 50Ю045yAMW Decision : Deferred No/Date:8/82‐
Case No.:109/10ノ82-
7 13.12.2017
ICase No.:198/17/82- IALC4/2016 9活丙下轟 「
翻脇蔦鳳赫
IPViLTD
|
IRLA File
i:09/24/040/00172/AM17/
lDecision: Deferred
「冨而瓦
C4/2016
lη器疏
5∽“4蔦戸 款
017
面
派死漏∝8/82‐ ~~
1倍″獄了
財
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|
| |
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ν2017 1Deferred
ノ
|
|
## case No.:2/l 6/82-ALC4l20l6 Party Name:ASTRAL-- Meet No/Date:8/82- Status:
TSTdRITECH PVT. LTD.
:xtcqtzotl
;Deferred
I
:13.12.2017
| |
|り3 HQ Fi13
IRLA File
134/24/040/00100/AM17/
1習鼎α
tt Ю略"B誰ち
4仰2∝81
| :ALC4/2016
IParりName:J.B.
ICHEMICALS&
PHARMACEUTICALS
iLIMITED
ICase No.:48/11/82-
一
一―
一
二
一
|
11241Ч 9.1収
レ
4醜臨脇高戸瑶珊轟/Am7=問郷
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fOr l,f?翌
F「盟^:営ゝ^`T_111
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:ビ611/34イ2016日仰
Ormsll
l ´J ____ . 1 1 .●
1 _ __J_`ムL^_^_:ぃ.,■Ar らnJ r4_fOrr●Hヤho rnくo l
ldated 3rd April′
2017 uploaded at the end oftheSe rninutes and deferred the case. |
IMeetNo/Dtte:8/82-
lALC4/2017
113.12.2017
rStatus:
:Deferred
125
鵬避掲
"Ю“劉/劇″
膨棚υ剛“ハm71冊辮Юヌ""∽2B鳶ち
4∝2∝8
|
剛漏扁
iCase No.:29/16/82‐ALC4/2016:Ptt Name:AUROBINDO
PHARMA LIMITED
躙暉~町…
1悧鼎α酬∞“"31
| |
1器3児5υ0084αAM″
: The Committee decided
'o Pharmaceuticals forwarded
November, 20L7, uploaded at the
to ratify norms based on the recommendation of
O.M. No3501168/2017-Pl(Norms) dated 15th
end of these minutes or as applied by the firm
ichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary
as per decision of NC.
IMcet No/Date:8/82- IStatus:
:ALC4/2017 :DeFerred
i13.12.2017 1
鯰9鵬
掲5剛鯰0鳳m7膨
枷
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8
Decision : Deferred
~Ψ而
~‐剛
|
「儡面藤囮蕊耐
il3 I iCase Xo.:ZlrySS- AL(,3l20l6 inurry Narne'SRIAM LABS
み
'Mect No/Date:8/82¨
Pa●y Name:SUN
PHARMACEUTICAL
INDUSTRIES LTD.,
‐Mcet No/Date:8/82-
‐ALC4/2017
.13.12.2017
HQ File
:Approved
幌fer…
…
……
lDate:24.01.2018
: The Committee decided to ratify norms based on the recommendation of
o Pharmaceuticals forwarded O.M. No35OtLl757l2015-Pl(Norms) dated 2nd May,
20L6, uploaded at the end of these minutes or as applied by the firm whichever is less
## para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision
NC.
iRLA File :Lic.No/Date:0910063922
1:09/24/040/00181/AM17/ 114.07.2016
,PRIVATE LIMITED
:ALC4/2017
113.12.2017
## Case No.:43/16/82‐
ALC4/2016
lStatus:
lDeferred
I
IRLA File Lic.No/Date10910063938 1Defer
l:09/24/040/00213/AM 17/ 115.072016 :Date:24.01.2018
Meet No/Date:8/82-
ALC4/2017
13.12.2017
ILic.No/Date:0910063947 1Defer
119.07 2016 1Date:24.01.2018
Decision : Deferred
F晉じ羽誌
RTI1/82‐
~~~~~~「
霊露慈蕊霊ま勇
1評喜
[」
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器脱蒜蕊
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…lM温ふ而
…
PHARMA PRIVATE
LIMITED
RLA File
:09/24/040/00132/AM17/
:status:
,Deferred
Lic No/Date:0910063967 1Defer
21.07.2016 :Date:2401.2018
ALC4/2017
13.12.2017
'Mect No/Date:8/82-
:ALC4/2017
113.12.2017
P鉗りName:REANNON
PHARMACEUTICALS
IRLA File
:03/95/040/00327/AM17/
1造:〕辮膏聯
82‐ ‐~
113.12.2017
P訂りName:FuSENIUS
IKABI ONCOLOGY
Status:
Deferred
〃
ヨ
「
|
IHQ File
i01/85/050/00110/AM17/
IHQ File
IDecision:Deferred
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柵
淵
儡
IπD粘
猟
7酬
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~
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2
‐ ,Case No.:32/16/82¨
I ALC4/2016
IPHARMA LIMITED
:Deferred i
,Status:
,Deferred
134
:Lic.No/Date:0310806427 1Dcfcr
i20.07.2016
IDate:24.01.20181
:
iDecision: Deferred
Case No。:27ノ16/82‐
| IALC4/2016
iCase No。:83/13/82‐
lALC4/2016
IHQ File
l:01/82/050/00711/AM17/
iDeferred
I
「
6
|
iDecision: Deferred
IB7猥霊淵謬
Bβ多
IMcet No/Date:8/82-
lALC4/2017
I LIMITED
,HQ Flle iRLA Flle
:01/82/050/00648/AM17/ :05/23/040/00211/AM17/
IlDecision : Deferred
I
Meet No/Date:8/82-
Decision:The Committee decided to ratify norms based on the recommendation of
D/o Pharmaceuticals forwarded O.M.No35011/36/2017-PI(Norms)dated 17th
October, 2O!7, uploaded at the end of these minutes or as applied by the firm
ever is less under para 4.07 of HBP Vol.l. RA concerned may take necessary
action as per decision of NC.
HQ File
:01/82/050/00866/AM17/
1助角鵬OЮ釧
27ハm7
Mect No/Date:8/82-
ALC4/2017
13.12.2017
Lic.No/Date:3410042385
27.07.2016
淵ma“Ю
3992“
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4劇2∝8
一
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te:8/82-
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142
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IDRUGS
I&PHARMACEUTICALS
iPVT.LTD.
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402∝8
IP釘りName:ASIATIC
コ
143,Case No.:79/11/82-
ノ竹
~~面雨而面而:
Status:
Ｆ
Ｌ
ド
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IHQ Filc
:01/82/050/00611/AM17/
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1/82/050/00614/AM17/
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IRLA File
I
| :0 5 123 I 040 I 00 125 I AN4IT I
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iMeet No/Date:8182- tStatus:
IALC4/2017
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ILic.No/Dttc:0510399241 Detr l
127.07.2016
IDate:24.01.20181
,Decision: Deferred
Name:AARTI
婚‖ 銀
IDeferred
RLA File
|:03/94/040/00177/AM17/ 128.07.2016
IP訂りNamc:SANDOZ
IPRIVATE LIMITED
rMeetNo/Date:8182- lstatus:
1徴
"獄
了
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| |
RLA File
Lic.No/Date:03 I 0806790 iDefer
10208.2016
IDate:24.01.2018:
,Decision:
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一
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IDecision:The Committee decided to ratify norms based on the recommendation of
D/o Pharmaceutlcals forwarded O.M. No35011/367/2016-Pl(Norms) dated
INovember′ 2017′ uploaded at the end of these minutes or as apphed by the firm i
● _ 1 _ 1
INOVerFlυ er′ ∠υェ′′ uν :υ ●u●u OL L::0 し‖u Vi ●1,‐ ‐… ……………~― ―‐ ―― ¬ = ・
、
lwhichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessaryl
iaction as per decisiOn ofNC.
ル
:うお50/00638/AM17/ IЮ 5/23/040/00229/AM17/ '9.08.2016 1
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ICase No.:78/13/82¨
IALC4/2016
P霞りName:HELLO PAINTS
,(P)LTD
:RLA File
岡覚蕊奮奢罵商
I~
113.12.2017
ニ ー
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~町
~|
:01/82/050/00645/AM17/ 1:05/23/040/00220/AM17/
:11.08.2016
|
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IDecision:Deferred
||,バッキleЮ 510399449 1Pc,1
lg駆ち
4.01.20181
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1155,従ガ∬ぱυ
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ParりName:GLAND
PHARMA LIMITED
IMeet No/Date:8/82-
:ALC4/2017
,Status:
'Deferred
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|
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面面薦面画面囲
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iDate:24.01.2018
.Case No.:19/13/82¨
ALC4/2016
ParりName:FRESENIUS
IKABI ONCOLOGY
ILIMITED
|
HQ File
:01/82/050/00647/AM17/
RLA File
:05/23/040/00234/AM17/
Decision : Deferred
## Case No.:15/16/82¨
ALC4/2016
HQ File
:01/82/050/00832/AM17/
1需 S
1苗爵苗ご~~~
IDeferred
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I
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159
1漑蔦:蕊万
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|
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Decision : The Committee decided to ratify norms based on the recommendation of
'
:O/o Pharmaceuticals forwarded O.M. No35011/68/2017-Pl(Norms) dated
15th
′ 升
File
Ｆ
Ｌ
ド
ー
No/Date:8/82-
7
13.12.2017
IDate:24.01.2018
minutes or as aPPlied bY
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「
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3No■163/13/82‐
IALC4/2016
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l13.12
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.:09/24/040/00301/AM17/
|
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|
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1 1Case No.:140/16/82‐ ParりName:SIUTRA IMeet No/Date:8/82‐ ,Status: |
1 1ALC4/2016 1SPECIALITIES PVT.LTD。
, IALC4/2017 1Approved i
l l l
‐13.12.2017 1 :
| _
‐‐‐ '
| IHQ File lRLA File Lic.No/Date:0410162242 1 1
1167:o1/82/050/00957/AM17/ :04/24/040/00265/AM16/ 102_092016 1 1
1 :__ _ __ __ _
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|ヘ
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|:01/82/050/00791/AM17/
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1641責O rii`
:Deferred
iCase No。:170/13/82-
File
::01/82/050/00798/AM17/
1 lALC4/2016
,Party Name:ORCH
|:01/82/050/OH 57/AM17/
RLA File
l:09/24/040/00292/AM17/
甲繹ぽ~椰繭蕊諦
‐
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:慧]蕊11:111↓I茅
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Pa“y Name:REINE
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|
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i:3 4 I 24 I 040 I 00 I 5 4 I AN{|T I
lDecision :Deferred
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9
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iCase No.:100/16/82¨
|
:
ミ
: |
|
P
:ALC4/2016
|
:
1器島泥
5υ00917AM17 ~
鳳L/
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~魏よ氏
::蒸11:(lI咄請軌ダ:漱1■
|口4晨霊淵″り
17/8年
′ 7
: lwhichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary:
i
iaction as per decision of NC.
1鵬d
ILic.No/Date:0310807613
B鮨ち
4劇洲轟
|
' iCase No。
:167/20/82‐
1 lALC4/2016
: |
IMcet No/Date:8/82-
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113.12.2017
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3.12.2017 1
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i
lDecision :Deferred
1器疏5υOH 70/AM17
IHEALTHCARE LIMITED
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109/24/040/00246/AM17/ 冊… 臨薫
jDecision :Deferred
~孵
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|:01/82/050/01168/AM17/ :09/24/040/00310ソ
|:01/82/050/01168/AM17/ :09/24/040/00310/AM17/ 108.09.2016 1 1
175 1Decision:The Commtttee decided to ratify norms based on the recommenda■
on ofi
laction as per decision of NC.
~~ 3/82‐
IALC4/2016
口
6田脱蕊島蔦;
ParりName:StJN
PHARMACEUTICAL
INDUSTRIES LTD.,
RLA Flle
:05/24/040/00264/AM17/
,Status:
:Deferred
IINo/5晟ま
bbibjう5“う
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:08.09.2016 1Date:24.01.2018
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「
^DeLI轟百
Paty Name:SUVEN LIFE
ISCIENCES LIMITED
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:09/24/040/00256/AM17/
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:0910064101
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|
轟蕊
Decision :Deferred
「
ICase No.:166/13/82‐
IALC4/2016
1HQ File
101/82/050/00794/AM17/
IDecision:Deferred
,Case No.:206ノ17/82¨
:ALC4/2016
1HQ File
:01/82/050/01167/AM17/
F・
IPa●7Namc:AUROBINDO IMcetNo/Date:8/82-
PHARMA LIMITED IALC4/2017
1 113.12.2017
RLA File lLic.No/Datei09 10064133
:09/24/040/00277/AM17/ 112.09.2016
,Status:
iApproved
1
179 Decision: The Committee decided to ratify norms based on the recommendation of
:D/o Pharmaceuticals forwarded O.M. No35OL1,/6812O17-Pl(Norms) dated
15th
,November , 2O!7, 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
」
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⌒
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・
:03/94/040/00487/AM17/ 116.09.2016
ParりName:MAHIMA LIFE
iSCIENCES PVToLTD.
國
而
~
ALC4/2017
13.12.2017
| IDecision:Deferred
|
二I二
| 1聯お掲
5υ00907ハMW
i:05/24/040/00229/AM17/
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聞瑞温瀞I~1協鵜高
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3/
閣需而而臨:蔦
## Case No.:105/13ノ82‐
IALC4/2016
ヘ
,Decision :Deferred
iStatus:
IDeferred
Name:MAHIMA LIFE
No/Date:8/82‐
IALC4/2017
113.12.2017
l iCase No。16/20/82‐ ALC4/2016 1ParりNamc:MAHIMA LIFE ヽMcet No/Date:8/82-
1徴敏鰍了
iro.oe.zot o
Status:
,Deferred
| I FCIENCESPVToLTD.
1185舞O File
‐RLA Flle
| :01/82/050/01183/AM17/
:Deferred
IDecision:The Commtttee decided to ratify norms based on the recommendation of
D/o Pharmaceuticals forwarded O.M. No35011/217/2017-Pl(Norms) dated
l^_ = ^^´ _ i : : ●
●:__ __J _rムL_^^ _^:― …ι^^ ^_ ^´ ‐いい::^月 L、′+hハ fir_
iNovember,2077, uploaded at the end of these minutes or as applied by the firm
lwhichever is less under para 4.O7 of HBP Vol.1. RA concerned may take necessary
iaction as per decision of NC.
.Case No.:72/16/82‐
IALC4/2016
鵬鳳
IHQ Filc
i:01/82/050/00889/AM17/
鵬ま赫`臨蕊
IDecision:Deferred
ぽ :1‐I
IRLA File
l:08/24/040/00242/AM17/
勢
1 lё五
`き
｀こlib夕iJた2: 'att NameJ.B.CHEMICALS McetNo/Dtte:8/82-
| IALC4/2016 1&PHARMACEUTICALS
‐ALC4/2017
1 1LIMITED
‐13.12.2017
1聯為
ed
,
1uq nite
IRLA File
i:03/94/040/00516/AM17/
ILic.No/Date:0310807914
120.09.2016
:01/82/050/00731/AM17/
: The Committee decided to ratify norms based on the recommendation
ID/o Pharrnaceuticals for、″arded O.Mo No35011/406/2016-PI(Norrns)dated
9thi
t
10CtOber′ 2017′ uploaded at the end of these rninutes or as apphed by the firrni
lWhiChever is less under para 4.07 of HBP Vol.1. RA concerned may take necessaryl
laction as per decision of NC.
Name:ASIATIC
IDRUGS
1響星悧
,CEUTICALS
IRLA File
:05/23/040/00214/AM17/
IMect No/Date:8/82‐
1告
"盤
了
iDeferred
1
IMcet No/Date:8/82‐
IALC4/2017
113.12.2017
IHQ File
l:01/82/050/00719/AM17/
ILic.No/Date:0810138723
122.09.2016
[U..irioo : The Committee decided to ratify norms based on the recommendation of
I
ID/o PharmaceuJcaにforwarded OoM.No35011/414/2016-P!{Norms)dated
♂
hi
ISeptember′ 2017′ up:Oaded at the end of these rninutes or as app‖ ed by the firrni
iwhichever is less under para 4.O7 of HBP Vol.l. RA concerned may take necessaryl
I
..
r
.!
-- .tt?
i
laction as per decision of NC.
I
ぜ従掘層脱‐IP鉗りName:J.B.
ICHEMICALS&
'PHARMACEUTICALS
iLIMITED
IMeetNo/Dtte:8/82‐
lALC4/2017
113.12.2017
,Status:
iDeferred
)
i
1悪聴評
~臨薦猾
l iCase No.:13/17/82-
| :ALC4/2016
け2聴温蕊蔦耳
IParty Name:GUJARAT
10RGANICS LIMITED
|
IRLARb
■υ l′ OZ′ υOυ ′υυソ′41′ AlVl l`
| IDecision:Deferred
103/94/040/00585/AM17/
| ~~~
ヽRLA File
:09/24/040/00341/AM17/
~1需
繹
6/82‐~
'Partv Name:PANERA
IBIOTEC PVT.LTD.
|
IRLA File
i105/24/040/00307/AM17/
IDecision:Deferred
~ ~~
丁
~~|
ドη靡
蔦
「
剛鸞罵瀞翻亥耐臨蒜:
l lD冨商品
~輛
通群蔦
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~~~~~~――一一一一―
'Party Name:SUVEN LIFE
iSCIENCES LIMITED
IRLA File
109/24/040/00339/AM17/
Decision :Deferred
Party Name:AMl ORGANICS Meet No/Date:8/82-
■981Case No。:90/13/82-
ク
…
画面蔽ご~~~~|
⌒
1柵淑
αHETERO LABS
No/Date:8/82-
IALC4/2017
113.12.2017
::認ら
″情よ°
"“面
"忠温ふ漁よ
r
Decision:Deferred
|
|り
5 FHQ File
| |:01/82/050/00926/AM17/
IMcet No/Date:8/82-
:ALC4/2017
:13.12.2017
ILic.No/Date:0510399924 1Defer l
128.09.2016 1Date:24.01.20181
1織ed
:ALC4/2017
iDeferred
113.鯰.2∝7 1
:Lic.No/Date:0910064206 1Defer
lg蔦ち
4.01.20181
lzs.os.zorc
i~~「輛面己ル】
5面
:HQ File
:01/82/050/00718/AM17/
IDeclslon:Deferred
## Case No.:128/16/82¨
ALC4/2016
ICase No.:114/20/82-
IALC4/2016
Par"NameiCADILA
PHARMACEUTICALS LTD.
RLA File
:08/24/040/00260/AM17/
~聞
薄F/82-~
:[ilil]:1'i:31チFT5商1羹」
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「邪
1 職晏卜
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r199 p..irion : The Committee decided to
'
;D/o Pharmaceuticals forwarded O.M.
,
iOctober, 20L7, uploaded at the end
r
whichever is less under para 4.07 of
I
:action as per decision of NC.
ratlfy norms based on the recommendation ofl
No35011/69/2017-Pl(Norms)dated 12thl
of these rninutes or as app‖ ed by the firml
HBP Vol.1. RA concerned may take necessary
ParりName:RA CHEM
iPHARMA LIMITED
IMeet No/Date:8/82-
ALC4/2017
11312.2017
tstatus: i
iApproved
1200
IHQ File RLA File Lic.No/Date:0910064222 1 1
1:01/82/050/01291/AM17/ :09/24/040/00352/AM17/ 130.09.2016 1 1
1Decision:The Committee decided to ratify norms based on the recommendation ofi
lD/o Pharmaceuticals forwarded O.M. No35011/244/2017-PI(Norms) dated i
INovember′ 2017′ uploaded at the
lwhichever is less under para 4.07
iaCtiOn as per decision ofNC.
end of these minutes or as applied by the firm i
of HBP Vol.L. RA concerned may take necessaryi
J
~麒
6/82‐
1
P01“IIざ………… …
:01/82/050/00886/AM17/
IPaty Name:DHANUKA
ILABORATORIES LTD.
IRLA File
:05/23/040/00310/AM17/
IMcetNo/Date:8/82‐
lALC4/2017
jStatus:
iDeferred
I
113.12.2017
1譜∬
%Rlα
05103999608鮨ち
4.01.20181
」
猥霊脇∬た
6だか
|
瓢
鳳、
I話丁
Paty Name:INDO PHYTO
ICHEMICALS PVT LTD
RLA File
105/23/040/00293/AM17/
―
一面
Deferred
1202
~「派雨読藻雨彊而而万靡薦~~~~
lo+. ro.zoro
I
IDate:24.01.20181
|
」
203猛霊淵f2/17β
2‐
ParりName:MYLAN
ILABORATORIES LIMITED
IRLA Flle
l:09/24/040/00305/AM17/
IMcet No/Datc:8/82‐
ALC4/2017
13.12.2017
ILic.No/1)ate:0910064230
105.10.2016
'i
"-
-"-___
i
,Status:
I
,Approved
l
|
:HQ File
l:01/82/050/01143/AM17/
3タ
i
⌒
|
lDecision :Deferred
| IDecision:Deferred
|
Decision : The Committee decided to ratify norms based on the recommendation of
D/o Pharmaceuticals forwarded O.M. No35011/90/2017-PI{Norms) dated
November′ 2017′ uploaded at the end of these rninutes or as app‖ ed by the firrn
whichever is less under para 4.07 of HBP Vo!.l.
action as per decision of NC.
RA concerned may take necessary
|:01/82/050/00972/AM17/
1
206器脇蕊諦II蔦
翻ぽ」~諄『~~
れた。
｀6あ五
Iよ631080843j Defer~~… …
117.10.2016 1Date:24.01.2018
]]CaseNo.:200/l7/82-PartyName:AURoBINDoMeetNo/Date:8l82-,Status:
:
ALC4l20l6
PHARMA LIMITED
tALC4l20l7
tDeferred
)
)
13.12.2017
204 Hq rit.
RLA File
Lic.No/Date:0910064252 Defer
1 ;0ll82l050l0l16llAMl7l 1:09l24l040l003l2lAMl7l 106.10.2016
lDate:24.01.2018
i
1巌轟器轟満計」監翌I
:FaseNQ:り
17慇2¨ALC″20161辮
が♀wttmNT
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Å面Й竃」
["寵猟よ1焉
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| IDecision:Deferred
IM‐献……辮源¬
:ALC4/2017 :Deferred
l13122017 :
:Lic.No/Date:0310808422:Defer
17.10.2016 :Date:24.01.2018
,
ヘ
IP冨りName:CIPLA
「MTED
:RLA File
l:03/94/040/00617/AM17/
IMect No/Dttα 8/82-
|
IParりName:CIPLA
ILIMITED.
IRLA File
l:03/94/040/00622/AM17/
j
iDecision: Deferred
File
i:0 I I 82 / 0 5 0 I 00992 I Alr{t 7 I
IParty Name:REANNON
IPHARMACEUTICALS
RLA File
IMeet No/Date:8/82‐
IALC4/2017
113.12.2017
ILic.No/Date:0310808412
117.10.2016
ｄ
Ｓ
ｔ
ａ
ｔ
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ｓ
‥
¨
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鮮
―
iCase No。:107/16/82-
lALC4/2016
lHQFile~~…
……… ~
:01/82/050/00924/Av17/
Decision : Deferred
| ICase No.:130/20/82¨ ParりNamc:MYLAN IMcet No/Datc:8/82- IStatus: |
| IALC4/2016 LABORATORIES LIMITED IALC4/2017 1Approved l
: | 113.12.2017 1 :
| IHQ File lRLA File lLic.No/Datei0910064272 1Defer l
l :01/82/050/01307/AM17/ :09/24/040/00350/AM17/ 119.lo.2016 Date:24.01.20181
,212 Decision:丁he Commtttee decided to ratify norms based on the recommendation of
212 Decision: The Committee decided to ratify norms based on the recommendation of
, '.D/o Pharmaceuticals forwarded O.M. No35011/196/20t7-Pl(Norms) dated:
:November, 2017, 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
,action as per decision of NC.
| ICase No.:134/20/82-
1 1ALC4/2016
甲封温
『
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1良二A lli3 ‐ :二i`|ヽ。
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:09/24/040/00390/AM17/ 120.10.2016 1Date:24.01.2018:
1 1ハ
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1 101/82/050/01311/AM17/
1 ,I)eclslon:Deferred
|
1 lCase No.:116/20/82-
1 'ALC4/2016
12141責Orile
l ,01/82/050/01293/AM17/
1 ,Case No。:51/16/82¨ Pan/Name:IND¨ SWIFT
ヽ4eet No/Date:8/82‐ Status:
1 lALC4/2016 LABORATORIES LTD., IALC4/2017 1Deferred
1 1 113.12.2017 1
F5鵬脱鳥
:∴jl↓1' 彦規,鳳ふm7 鰤∬鼎α
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4劇2∝8
,
:Decision :Deferred
| :‖11111∫:憩‖堵
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Ю120181
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IPar″ Namc:DALAS
IBIOTECH LTD.
RLA File
No/Date18/82-
:18.10.2016
113.鯰.2017
ILicoNo/Date:0510400138‐
IDefer
IDeferred
|
:Date:24.01.20181
ParりName:ARENE LIFE
SCIENCES LIMITED.
IRLA File
:09/24/040/00318/AM17/
―
|
‐Case No.:131/20/82¨ | :I I
陽ち糀υ
00319晨m7 階だ幽α
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4劇2∝J
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IALC4/2016
217責Orile
i:01/82/050/01308/AM17/
扉cision :Deferred
「F漱
3耐…
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|
靡
|ヽ蕊;Am7蔦脇蕊覇鳳
~~閉
齋F面而
「
~~
2181Dedsion:千he com吊忙tee decided~蔦満
濡罵話
~based on thE~蔦
ぎ品
D/oPharmaceuticalsforwardedO.M. No35OIL/676/2012-Pl(Norms)dated LZth
March, 20L3, 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
decision of NC.
IHEALTHCARE LTD
IMcet No/Date:8/82‐
IALC4/2017
13.12.2017
｀
辮濡繭38976
J
絲I蔦~~|
:Approved
ICase No.:152/20/82¨
IPa■y Name:BIOLOGICAL E
IALC4/2016 :LTD
Decision :Deferred
2191首0「ile‐ IRLAFie´
~
101/82/050/01329/AM17/ :09/24/040/00220/AM17/
「
断面市122/16/82‐ ~~~~‐
いげ満驀し両面
IALC4/2016
|
IHQ File RLA File
l:01/82/050/00939/AM17/ :08/24/040/00289/AM17/
220 Decision : The Committee decided to ratify norms based on the ,..or*.ndation of
iOTo eharmaceuticals forwarded O.M. No35OtL/4012017-Pl(Norms) dated
8th
iNovember,2O!7, uploaded at the end of these minutes or as applied by the firm
rwhichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary
rwhichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessaryl
laction as per decision of NC.
:
5夕匡
rDecision :Deferred
|
揚
1警粽"隈
Pa」りName:EMME■lNAR
PHARMA PRIVATE
LIMITED
諄‖ 纂
lmed
IDecision:Deferred
## Case No.:15/17/82…
ALC4/2016
HQ File
:01/82/050/00836/AM17/
瓢
Hc.No/Dttα 0310808773面粟r~~~~
26.10.2016 1Date:24.01.2018
蕩〒両面両面両面
「
~~匝
面高而扇面藤~~
:LABORATORIES LTD.
1223[
囲戸0400295臨蕊
ALC4/2017
13.12.2017
## Case No.:19/16ノ82-
ALC4/2016
ALC4/2017
13.12.2017
:Decision:Deferred
Ｆ
Ｌ
Ｆ
Ｉ
|
丁
臨蕊百
Decision: Deferred
Party Name:IOL
iCHEMICALS AND
PHARMACEUTICALS
Case No。:130ノ16/82-
:01/82/050/00947/AM17/
鵠図蕊
「
'Case No.:165/20/82-
ALC4/2016
Decision : Deferred
―
囲需而1389971需蕊蔦
縣聞ご
蕊I戸
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バ鼎α
tt Ю“““
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イ
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;:i又
~
Pa■y Name:MICRO LABS
囲
満
戸
Lic.No/Date:07 1 0 I I 0609 iDefer
Date:24.01.2018
:01/82/050/01327/AM17/
:01/82/050/01334/AM17/
iCase No.:148/20/82‐
IALC4/2016
P釘りName:HETERO LABS
LIMITED
諄‖酬秘
Lic No/Date:0910064346‐ Defer
町
…
Date:24.01.2018
Status:
Deferred
「赫
…
103.11.2016
Lic.No/Date:0910064336
fcr
03.112016
Decision : Deferred
lP嘉|・面圧話Ъ:ALKALOibS
:09/24/040/00426/AM17/
:01/82/050/01325/AM17/
Date:24.01.2018
iCase No.:160/20/82-
IALC4/2016
234[事
0両FIご
西藤
No.:25/20ノ82-
夕7
Meet No/Date:8/82-
Date:24.01.2018
⌒
: Deferred
Name:ENAL DRUGS
No/Date:8/82‐
LTD,
7
13.12.2017
File
11.2016
Name:EYTAN LABS
0064347
Ｆ
Ｌ
Ｆ
Ｉ
:鳳17
11.2016
11.2016
Name:VIRUPAKSHA
No/Date:8/82-
7
13.12.2017
: Deferred
ICase No。:16/14ノ82-
HQ File
i01/82/050/00814/AM17/
IRLA Flle
l:04/24/040/00133/AM17/
圏獄T~
ILIMITED
## Case No.:92ノ1/82‐ALC4/2017
Mcet No/Date:8/82-
ALC4/2017
13.12.2017
Lic.No/Date:0310809129
11.11.2016
一
３
８
一
２
『
Ⅷ冨″師
~1
RLA File
:05/23/040/00372/AM17/
一
９
一
２
３
lParty Name:MYLAN
}LRBoRAToRIES LIMITED
I
:造き』輝ναν
82¨
i13.122017
RLA Rb ~~~~~~~~― れた。
No/DtteЮ 910664386
IЪち刷
ioЮo430/AM17 1∵∬%羅α
一
―
知冊品;ハm7T
RLA File
:09/24/040/00421/AM17/
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焉
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罐
:
|
1需策ぎめぬδ
あわ
B壼ら
11:∴
一
Ｓ
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ｔ
ｕ
ｓ
‥
¨
IDecision:Deferred
ICase No。:124/20ノ82‐
~F繭嶽需=理磁ぽ而
Lic.No/Date:0910064382
15.11.2016
″δ
:01/82/050/01301/AM17/
Decision : Deferred
| IALC4/2016
1 1
lParty Name:HARMONY
ILicoNo/Date:0410162482
ILIMITED
IRLA File
ILic.No/Date:0510400404
!Date:24.01.2018
j
1鵬d
―
.=.
「
li:淵響
9/20/82-
語屈願ふ裏蔦瀞戸~
PaゥNamcAKTINOS~~…
…
1蕗読No/Dttc8/82‐
iCARE PRIVATE I
》 |
HEALTHCARE PRIVATE IALC4/2017
LIMITED
13.12.2017
Lic.No/Date:0910064399 1Defer
:09/24/040/00445/AM17/
18.11.2016
,Date:24.01.2018
「甲IW
.01.2018
:01/82/050/01304/AM17/
Decision : Deferred
RLA File
:09/24/040/00459/AM17/
~
「
~~
244「
i「::lli;:ii::;::i:;テ
~~~~
Pa“y Name:AUROBINDO
PHARMA LIMITED
RLA File
:09/24/040/00419/AM17/
'Meet No/】
Date:8/82-
1倍″盤了
tstatus:
lDeferred
l
騰
、:
Decision: Deferred
:01/82/050/01298/AM17/
1
:
Lic.No/Date:0910064401
118.11.2016
## Case No.:122/20/82‐
ALC4/2016
HQ File
:01/82/050/01299/AM17/
ALC4/2017
13.12.2017
Decision : Deferred
## Case No.:128/20ノ82-
ALC4/2016
l[IIII「:~~:
γ7冊蕊扁
IRLA Fne ~
|:0924/040/00436/ AM17/
lDGsion: Deferred
″′
1貯淵η隈
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一
¨
¨
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ｅ
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―
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]
lParty Name:HETERO LABS lMeet No/Date:8182-
Lic.No/Date:0910064402 1Defer
Irs.r r.zoto
Name:HETERO LABS
No/Date:8/82‐
IALC4/2017
Itt.tz.zon
ｄ
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113.12.2017
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一
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一
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―
―
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―
―
―
―
―
―
¨
―
―
|
IDecision:Deferred
## Case No.:66/17/82‐
ALC4/2016
而~
Patt Name:MEGHMANI
INDUSTRIES LTD,
剛蕊1鳥耳
Meet No/Date:8/82-
ALC4/2017
13.12.2017
Mcet No/1Date:8/82¨
ALC4/2017
13.12.2017
Ｆ
Ｌ
Ｆ
Ｉ
Defer
Date:24.01.2018
## Case No.:91/17/82-
:01/82/050/01052/AM17/
Mect No/Date:8/82-
ALC4/2017
13.12.2017
Meet No/1Date:8/82-
ALC4/2017
13.12.2017
畷
~
|
Defer
Date:24.01.2018
## Case No.:120/17/82-
LABORATORIES LTD.
田:扁蔦
=蔦
## Case No.:99/17ノ82-
ALC4/2016
Party Name:SAURAV
CHEMICALS LTD,
Ｆ
Ｌ
Ｆ
Ｉ
:01/82/050/01048/AM17/
HQ File
:01/82/050/01047/AM17/
ParりName:ALCHEM
INTERNATIONAL PVT.
LTD.
Mcet No/Date:8/82‐
ALC4/2017
13.12.2017
Meet No/Datc:8/82‐
ALC4/2017
Status:
Deferred
Date:24.01.2018
Defer
Date:24.01 .20 I 8
Party Name:ASIATIC
&PHARMACEUTICALS
## Case No.:87ノ17ノ82‐
13.12.2017
Case No。:86/17/82-
ALC4/2016
Lic.No/Date:0510400474
25.11.2016
## Case No.:155/17/82‐
Pa=y Name:CIPLA
LIMITED.
Mcet No/Date:8/82‐
ALC4/2017
13.12.2017
ほ
間藷蔦LItt「~閉
出戸
10809205臨III蔦
Name:RONAK
Namc:ZIM
囲鼎α
08101"“ 0
Ｆ
Ｌ
Ｆ
Ｉ
## Case No.:129/17/82-
ALC4/2016
Party Name:DELTA
ALC4/2017
13.12.2017
:01/82/050/01090/AM17/
:01/82/050/01141/AM17/
RLA Filc
:03/94/040/00675/AM17/
Mcet No/Date:8/82‐
ALC4/2017
13.12.2017
Lic.No/Date:0310809370 1Defer
Date:24.01.2018
Lic.No/Date:0310809367 1Defer
28.11.2016
## Case No.:180/17/82‐
Paty Name:ENCUBE
ETHICALS PVT LTD
:03/94/040/00689/AM17/
Mcet No/Date:8/82‐
ALC4/2017
13.122017
58鵬疏
50ЮЮ
45蔦17 間濡υ
00綱夕
AM7
## Case No.:84/17ノ82-
Party Name:MOREPEN
LABORATORIES LTD.,
Lic.No/Date:0510400507
28.11.2016
Party Name:SENTISS
PHARMA PVT.LTD
Date:24.01.2018
ALC4/2017
13.12.2017
肛
A Ⅲe ν
Am7トドら鼎α“Ю““
・
卜
05/24/040/00423/AM17/
:01/82/050/01213/AM17/
## Case No.:116/17/82-
ALC4/2016
Meet No/Date:8/82-
ALC4/2017
13.12.2017
瓢
鳳
囲鼎α剛∝ω"6
Party Name:AETHER
No.:128/1/82‐
:01/82/050/01482/AM17/
y~~顧可Π
7高扇
「
~
:04/24/040/00145/AM17/
ParりName:GLENMARK
1262い:雨而源
ケ
iMeet No/Date:8/82-
I
隅五而
「
~
6ハm7~
: Deferred
: Deferred
No.:36/20/82-
: Deferred
FINOCHEM PVToLTD.
No/Date:8/82-
Ｆ
Ｌ
Ｆ
Ｉ
No/1Date:8/82‐
: Deferred
: Deferred
町
…
―一―――一―――一一―
――‐
=蓄
―TII ~…
… ‐~~~~一―
「
IてIふ薫蔦高帯高品落畜氣1亀r ……
臨話高蕊
i;「
~轟
痣
File~……………~瓢
蕩評画面耐圏瓢話:話
/94/040/00801/AM17/ 105.12.2
Ｆ
Ｌ
Ｆ
Ｉ
No.:31ノ1/82-ALC4ノ2017 P冨りName:RONAK
Decision: Deferred
ICase No.:78ノ17/82‐
Ｆ
Ｌ
Ｆ
Ｉ
Party Name:INDIA
語 B荒
ち
4岬叩
lDecision : : Deferred
Decision : : Deferred
~面
高高嘉面≡遮~~~
IPHARMACEUTICALS PVT
LTD
鍼醜¨ tus:
Deferred
Defer
Date:24.01.2018
:Decision::Deferred
Status:
話諏甲赫臨蕊高
ル
爾
^
iCHEMICALS
I
IMect No/Date:8/82‐
1仕
"盤
了
1織ed
1跳ち刷iOЮ0225ハM17
|:01/82/050/01385/AM17/
濤駆究
lα
34100427198鮨ち
4Ю L2018:
IMcet No/Date:8/82¨
,ALC4/2017
113.12.2017
ｄ
∬
Ｏ
Ｖ
Ｓ
ｔ
ａｔ
ｕ
柳
[´
淋
|、i::'AM7 1鷺
ち刷iυ0032αA剛7 1譜
らち認
αO譴∝392飢
|
lrool.lvw90l0l057lAM17/ i:0E/24/04ot0o326t&l4t'tt luo.tz.zvto
| _ -_
I
I
lDecision : The Committee decided to ratify norms based on the recommendation of
i
I
lO/o Pharmaceuticals forwarded O.M. No35011/3 46l2OL7-Pl(Norms) December, 20L7,
I
uploaded at the end of these minutes or as applied by the firm whichever is less under
Lpara 4.07 of HBP Vol.l. RA concerned may take necessary action as per decision of NC.
'
N∝96/rttZALC″ 2016二
獣
ぷ躙
CAl総
IGLYCOLS LTD。,
:ALC4/2017
1B■22∝7
IMcetNo/Date:8/82‐
1織ed
響舎
RPIACEU■CALSPVT I倍
敦鰍了
::01/82/050/01040/AM17/
Ъ
68猥謎胤122υ秘
PattNamα HINDYS LAB
IPVTLTD
:
:ALC4/2017
113.12.2017
:09/24/040/00492/AM17/
:01/82/050/01319/AM17/
Case No。:21/20/82‐
Party Name:JUBILANT
ALC4/2016
RICS LTD
:01/82/050/01042/AM17/
Meet No/Date:8/82‐
ALC4/2017
13.12.2017
Decision : The Committee decided to ratify norms based on the recommendation of
Dlo pharmaceuticals forwarded O.M. No35011/2 L7l2OL7-Pl(Norms) dated
November, 2OL7, uploaded at the end of these minutes or as applied by the firm
whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary
as per decision of NC'
~~~臨
厭涵驚鍛Ю
Paty Name:DIVIS
LABORATORIES LTD
PHARMACEUTICALS
LIMITED
RLA File
荻M17
面
## Case No.:22/20/82‐
ALC4/2016
Party Name:JUBILANT
GENERICS LTD
諸ぉ鼎αいЮ
4006お日蕩劇
2∝8
Mcet No/Date:8/82-
ALC4/2017
13.12.2017
Lic.No/Date:0510400686
08.12.2016
Lic.No/Date:0810139254
.09.12.2016
Mect No/Date:8/82¨
ALC4/2017
13.12.2017
Mect No/Date:8/82-
ALC4/2017
13.12.2017
Defer
Date:24.01.2018
Date:24.01.2018
:01/82/050/01199/AM17/
:05/23/040/00404/AM17/
## Case No.:81/17/82-
Party Name:BIO TECH
OPHTHALMICS PVT LTD
HQ File
RLA File
:08/24/040/00360/AM17/
## Case No.:46/20/82-ALC4/2016
Lic.No/Date:0910064468
09.12.2016
Case No。:37/20ノ82‐
1藻藻iOnT~~
## Case No.:118/20/82‐
均
「
: : Deferred
臨
i蕊再
Mcet No/Date:8/82‐
ALC4/2017
13.12.2017
面
08/24/040/00348/AM17/
Date:24.01.2018
Decision : : Deferred
Decision : : Deferred
l..iri* i , ff'r. Committee decided to ratify norms based on the recommendation of
D/o Pharmaceuticals forwarded o.M. No35 oLLlL8Ol2017-Pl(Norms) dated
23'd
, 2O!7, uploaded at the end of these minutes or as applied by the firm
is less under para 4.07 of HBP Vol.1. RA concerned may take necessary
ion as per decision of NC.
Decision : The Committee decided to ratify norms based on the recommendation of
D/oPharmaceuticalsforwardedO.M. No35OL1lL82/2017-Pl(Norms)dated
23'd
mber, 2OL7, uploaded at the end of these minutes or as applied by the firm
rever is less under para 4.07 of HBP Vol.1. RA concerned is requested to calculate
altow the quantity of input output norms on prorate basis'
276
1器島児50m6晨m71鷺角鵬υ
00355ハⅢ7
冨
赫
面
1柵柵猾
TD鱚
罐
町
開面高話T~開脇高而
~賭お辮卿
"η61
一
７
８
Ｆ
Ｉ
鳳
Ｆ
Ｉ
Ｉ
饂D貯‖銀陣
ed
Ⅲ7 1
グ
1.2018
: : Deferred
1184/AM17/
13.12.2016
Name:BIO TECH
No/Date:8/82-
PVT LTD
7
13.12.2017
Case No。:17/20/82-
ALC4/2016
File
No/Date:0810139270
1/AM17/
13.12.2016
1.2018
sion : The Committee decided to ratify norms based on the recommendation of
Pharmaceuticals forwarded O.M. No35 Otl/L82/2017-Pl(Norms) dated
23'd
ovember, ZOL7, uploaded at the end of these minutes or as applied by the firm
is less under para 4.07 of HBP Vol.t. RA concerned is requested to calculate
altow the quantity of input output norms on prorate basis.
Decision : The Committee decided to ratify norms based on the recommendation of
D/o pharmaceuticals forwarded o.M. No35ottlLSL/2017-Pl(Norms) dated
24th
', 20L7, uploaded at the end of these minutes or as applied by the firm
is less under para 4.07 of HBP Vol.l. RA concerned is requested to calculate
altow the quantity of input output norms on prorate basis'
*trtr, = Th. Crrmittee decided to ratify norms based on the recommendation of
'o Pharmaceuticals forwarded O.M. No35 Ofil8OlZ017-Pl(Norms) dated
23'd
ber, 2OL7, uploaded at the end of these minutes or as applied by the firm
r is less under para 4.07 of HBP Vol.l. RA concerned may take necessary
Decision : : The Committee decided to ratify norms based on the recommendation of
D/o Pharmaceuticalsforwarded O.M. No35OlLlLSt/2017-Pl(Norms) dated
24th
November, 2OL7, uploaded at the end of these minutes or as applied by the firm
whichever is less under para 4.07 of HBP Vol.l. RA concerned is requested to calculate
allow the quantity of input output norms on prorate basis'
脇馘嗣
五I
「~
Party Name: BIO TECH
10PHTHALMICS PVT LTD
allow the quantity of input output norms on prorate basis'
:~口蒟正面涵面蔽琵面彎藝蘇膏BЮ TECH、、
~薫
e∝NoDttα ν82」
ほTlll
| |~~~~~ ,PiTHALMICSPVTLTD I徴
敏盤了
狩
pproVed
1締
…
…
一
言
|
| |:0'82/050/01197/AM17/ 1:08/24/040/00362/AM17/ 113.12.2016 1 1
|
,器
eN∝η 劉
82‐ALC42m61器
冊
凪
wLTD
糠‖ 纂
File
IRLA File
ILic.No/Date:0810139259
113.12.2016
\ :0 t I 821 050 I 0 l2O3 I AMI 7 I
l:Os 124 I 040 I 003 64 I A}/'LT I
laction as per decision of NC.
|
８
‐
＾
‐
ｚ
‐
‐
‐
‐
‐
‐
―
―
―
iCase No。:27/20/82-ALC4/2016 Pat/Name:BIO TECH
I ,OPHTHALMICS PVT LTD
２
８
８
ｅ
ｍ
¨
¨
Ｍ
ｅ
Ａ
Ｌ
‐
３
．
ｄ
ｅ
∬
Ｏ
Ｖ
Ｓ
ｔ
ａ
ｔ
ｕ
柳
1鷺ち刷:0/00363/AM17/
Lic.No/Date:0810139258
lr3.t2.2ot6
I
Ｆ
Ｌ
Ｆ
Ｉ
DE薦満lbeferrea
Paty Name:JINDAL DRUGS
PRIVATE LIMITED
Ｆ
Ｌ
Ｆ
Ｉ
ｄ
ｅ
説
Ｏ
Ｖ
Ｓ
ｔ
ａ
ｔ
ｕ
柳
Ｆ
Ｌ
Ｆ
Ｉ
: The Committee decided to ratify norms based on the recommendation of
o Pharmaceuticals forwarded O.M. No35011/269/2017‐ PI(Norms) dated
November′ 2017′ uploaded at the end of these rninutes or as applied by the firrn
ever is less under para 4.07 of HBP Vol.l. RA concerned is requested to take
action as per the decision of the Norms Committee.
:01/82/050/01104/AM17/
1鴨脇5υ01327AM17
Decision :Deferred
りど
No。:19/1/82-ALC4/2017
Name:IND‐SWIFT
TORIES LTD.,
~[「
:}[「置百
3‐ ~~
MI熔
~
:Deferred
No。:142ノ17/82‐
Name:JINDAL DRUGS
No/Date:8/82‐
ATE LIMITED
:Deferred
No/Date:8/82-
13.12.2017
No.:35ノ1/82‐ALC4/2017
No/Date:8/82¨
No.:145/20/82‐
Name:INDIAN
No/Date:8/82-
7
13.12.2017
:01/82/050/01389/AM17/
剛扁扁
13.12.2017
iii"N"/D"t.s5 t o4oo?88
It+.tz.zorc
潜鮒纂
I
lDecision :Deferred
劉
了
IRLA RL
I:05/24/040/00445/AM17/
=鯰
_SUN~… ………
l L
IMcetNo/Date:8/82-
:ALC4/2017
113.12.2017
1漱濡潔愛::~~殴漱需
8/82-
RLA File
Lic.No/1Date:0810139295
15.12.2016
.01.2018
iStatus:
IDeferred
pefer―
―… …
lDate:24.01.2018
HQ File
:01/82/050/01174/AM17/
I
lDecision :Deferred
HQ File
:01/82/050/01137/AM17/
1鷺λ
ttυ00741/Am7
Lic.No/Date:0310809851
15.12.2016
iDecision :Deferred
1553ご
No.:18ノ1/82-ALC4/2017
1器島泥
5υOB77AM17
lp".ty N"r., inriir.rrus
IKABI ONCOLOGY
:LIMITED
RLA File
:05/23/040/00446/AM17/
面開扁蔦
:Decision:Deferred
:01/82/050/01218/AM17/
間麒蕊戸翻渕甲臨蕊
Decision : Deferred
## Case No.:44/20/82-
ParりName:HONEST BIO―
VET PVT.LTD
IMeet No/Date:8/82¨
IALC4/2017
113.12.2017
開脇蕊下~F漱戸面覇電誦Lil
Decision :Deferred
タヂ
^
i
iCase No.:18/20182-
:Pa■y NameiSUN
IPHARMACEUTICAL
INDUSTRIES LTD.,
RLA File
l:05/24/040/00429/AM17/
ｄ
Ｓ
ｔ
ａ
ｔ
ｕ
ｓ
‥
¨
:ALC4/2016
'Case No.:176/17/82‐
IALC4/2016
|
|
IPartyName:GITANJALI
iCHEMICALSPVTLTD
1借敏盤ソ
1鵬d
日本ち
4響洲
81
:Deferred
２
８
０
２
Ｎ
ｏ
・
‥
４
‐
姉
ａ
ｓ
ｅ
Ｌ
Ｃ
Ｃ
Ａ
'Party Name:HONEST BIO- rMeet No/Date:8182- :Status:
1295面i13
IVET PVT.LTD
1徴″盤了
IDeferred
t
1296
14フリ
IHQ File
ヘ
Party Name:TORIN
GANICS PVT LTD
「甲鱚正~~甲濡需=~~ ~野~
lParty Name:TORIN
ionceNlcs PVT LTD
I
1
IRLA File
13 5 r24 I o4o I oooTo/AM I 6/
ALC4/2017
13.12.2017
lDecision: Deferred
一
|
隅
1需扁蔦
Decision : Deferred
一
T翻温蕊蕊i「硼図蕊扁
Decision: Deferred
「
ICase No.:125/1/82-
IALC4/2017
Mcet No/1Date:8/82-
ALC4/2017
13.12.2017
Status:
Deferred
「
2
| :0 l/821050/0 147 8l A}l{|T I
r--ffi
ffi[d""tN"/D"t.,8/82--istat*r
i
IiIPRIVATEI,IMITEDiALC4/2OITlDeferredi
r |
|
ltt:z:ott
1297 fHri Fire
--k1-Ali1g -__--
"NolO"i.'OgrooO++s8lD"f.t --l
I l;0rir6 so/ot384tAMtlt l:oeDafiaofioso8/AMl7/ lzo.tz.zorc
lDate:24'01'20181
I lDecision : Deferred
-
I
1霊濡評庵ヌ
|
OPHTHALMICS PVT LTD
RLA File
l:08/24/040/00401/AM17/
ALC4/2017
13.12.2017
,Si"tutt
,Deferred
正
p
15爵::24.01.20181
13欝::24.01.20181
11)eferred i
|
IRLA File
lLic.No/nate:3 5 1 0045085
t;:35Da1040100045/AMl7/ lzl.tz.zorc
Party Name:BIO TECH
IMeet No/Date:8/82‐
IDecision:Deferred
い面而面耐
|
|I FINECHFMIC^LS
304
RLA File
:09/24/040/00509/AM17/
Decision : Deferred
Decision : Deferred
## Case No.:6/1/82‐ ALC4/2017
22/24/040/00083/AM17/
|
RLA File
:03/94/040/00855/AM17/
Ｆ
Ｌ
ド
ー
臨獅彎戸響癬~
翻
&而面臨I「扁
308 HQttle~~~~~~
IЮ 1/82/050/01386/AM17/
袢
RLA File
:08/24/040/00388/AM17/
Party Name:ASCENT
FINECHEM PVT.LTD。
,
Decision : Deferred
ICase No。:32/20ノ82-
ゞ′
へ
IDeferred
'
## Case No.:60/l/82- ALC4l20l7 'Party Name:AGIO
No/Date:8/82‐
I)eferred
'Date:24.01.20181
|r lDecision: Deferred
腔き棚ν∝ν
82
113.12.2017
ｄ
Ｓ
ｔ
ａ
ｔ
ｕ
ｓ
‥
¨
1蹴辮α“ЮЫ鯰
・B鮨ち
4劇2∝81
|IDecision:Deferred
l15ここ
II13=:Б こ罵喜
:ここ | || 1 1
1習器α“Ⅲ
"″7B荒ち
4劇2m81
IPatyName:FRESENIUS
iKABI ONCOLOGY
ILIMITED
滞‖纂
1織ed
1露褒墓墓墓要ヨ褻亜藁姦
l lCase No.:53/1/82¨ ALC4/2017
l i
fase No■53/1/82¨ ALC4/2017:3rりNameCIPLA
| |
響臨
IHQ File
i:0 1 1 82/ 050 1 0 1 407 l ANI|T /
「
MttD
lp r△
ロ
RLA File
1需辮α
"Ю譴
0380開扁蔦
■ヨレー
■■■V
:03/94/040/00915/AM17/
'04′ VフV′ V■'V′
′A■▼■■′′ |.V′
′ノマ′V7V′ VV′
■_/′ r■■
Decision : Deferred
IParけName:MANGALAM
IDRUGS&ORGANICS
ILIMITED
1鷺λ
ttυ00566ハm7
l5 Decision: The Committee decideJ to ratify norms based on the recommendation of
iO/o pfr.rraceuticals forwarded O.M. No35OL1/86412015-Pl(Norms) dated
lOth
lApril, 2OL7 , uploaded at the end of these minutes or as applied by the firm whichever is
iless under para 4.07 of HBP Vol.1. RA concerned is requested to take necessary action
ras per the decision of the Norms Committee.
ゞ算
1造:』別ν
tC8/82‐
113.12.2017
1織
ed
iCaSe
1
|
P笛
"Name:GLENMARK
,PHARMACEUTICALS
ILTD.,
lMeet No/Date:8/82-
:HQ File
IRLA File
ILic.No/Dtte:0310810390
109・01・2017 1Date:24.01.20181
r lDecision : Deferred
| :0 l/821050/0 1408/AM 1 7/
:03/94/040/00805/AM17/
巨面17 ~~
lD..i.ioo tDeferred
319 薔麓雇蕊萬面蔦蔦戸~臨
蕊扁
鰤
両赫縣蕊
I
Mect No/Date:8/82‐
ALC4/2017
13.12.2017
群奮蔦
~~
Defer
Date:24.01 .201 8
fer
Date:24.01.2018
閉蕊蕊蔦蔦「~
Pa,y Name:CIPLA
LIMITED.
## Case No.:52ノ1/82‐ALC4/2017
町
‐…
F而瓦繭FF辮平
~理
P面
2-~
D;irtd i Deferred
RLA File
:05/24/040/00508/AM17/
,Status:
rDeferred
Meet No/1Date:8/82‐
ALC4/2017
13.12.2017
PttNamαRUSAN
IPHARMA LTD.
Meet No/Date:8/82‐
IALC4/2017
Decision : Deferred
プ
「
胃
面
而
面而
阿
需
認
「
~隅
孵
続
す
|
1lzffirc
呻
而面
〔
|:01/82/050/01381/AM17/
: Deferred
112.01.2017
1 ;CaseNo.:28/l/82-ALC4l20l7
NameiCADILA
||
:HEALTHCARE LTD
Fl° 1器島児
5υ∝
382竹Ylz
Itz.ot.zon
: Deferred
レ0 1
鱚
p21
IDZl lЧ♀′
l収
IPar″ Name:SUN
IPHARMACEUTICAL
IINDUSTRIES LTD.
323撥霊淵F20慇多
「
1器3児590126νAM17
|
RLA File
:03/95/040/00823/AM17/
|
圏需面薔
10600B源高I
Ｆ
Ｌ
Ｆ
Ｉ
fer
Date:24.01.2018
HQ File lRLA File
:01/82/050/01392/AM17/ 1:03/94/040/00699/AM17/
325 HQ Fiお
1
叩
蘇
~
臨
扁lm7 5810695
一
８
一
‐
・２
０
一
〇
一
４
．
一
路
|:01/82/050/01253/AM17/
Decision : Deferred
## Case No.:76/20/82-
ALC4/2016
IPaty Name:RESONANCE
SPECIALTIES LTD
―
一
―
|
Lic.No/Date:0310810742
124.01.2017
Status:
Deferred
Date:24.01.2018
## Case No.:3ノ1/82‐ALC4/2017
P霞″Name:DHANUKA
LABORATORIES LTD.
ALC4/2017
13.12.2017
開臨蕊
「
閉癬繭L・臨蕊
:01/82/050/01357/AM17/
一
３
２
８
臨
蔦鰤
RLA File
:02/24/040/00216/AM17/
辮
筋1020葡
‐
B漑11蔦
IDecision:Deferred
IRLA RL
i:08/24/040/00387/AM17/
賭 396061需」IttI
ICase No。:113/1/82-
Party Name:CORONA
uMEDIES PRIVATE
LIMITED
tDecision: Deferred
Stl
,
tDecision : Deferred
113.12.2017 1
|
File
File
rDecision: Deferred
No/Date:8/82¨
IDeferred
|
N∝:2/1/82‐ALC4/2017 1:Ъ
Rl鵠置::合も長
ALOIDS
IALC4/2017
113.12.2017
:Deferred
|
jZソ
IHQ File
「
P蘭
蔦而面iCψ017[悪
臨Ⅷ樅lM困
HQ File
:01/82/050/01367/AM17/
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ib4而磁=襟ぅ
11:蕊:
I
I
l i
」
iCase No。:108/1/82-
IALC4/2017
|¨認総~翻ア動
82‐ ぃ
~1
341器
島児
5υOИ62/AM17
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‐
‐
‐
‐
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‐
‐
‐
駐鬱
I百葛I
l ibもお
isibi t bιfeli3a
Mcet No/Date:8/82¨
ALC4/2017
13.12.2017
Status:
Deferred
i
gDecision: Deferred
脇
I
Sダ
:RLA File
l:05/24/040/00543/AM17/
;
lDecision: Deferred
, iCasc No.:105/20/82¨
: IALC4/2016
IPttvName:SAI MIRRA
ilhINOPHARMPVTLTD 諄鮮纂
lStatus:
tDeferred
File
i 西Ecigltl i bもferred
i^^^r__
,r,, IHO File
|
| IDecision:Deferred
I FttemJmぃ
Lα2m7 Pa呻
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8/82-
IPVT.LTD。, IALC4/2017
猛
51
File RLA File
Ю3.02.2017
一
３
３
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itlζ
=品
IItiん0/8'1
'ALC4/2016
:HQ File
:01/82/050/01338/AM 17/
Patt Name:ARVEE IMeetNo/Dtte:8/82-
LABORATORIES INDIA :ALC4/2017
PRIVATE LIMITED 113.12.2017
IRLA File Lic.No/Date:0810139667
:08/24/040/00315/AM16/ 1o7.02.2017
A File
IDefer ~~~~
pate24.01.2018
一
Paty Name:CADILA
‐HEALTHCARE LTD
108/24/040/00453/AM17/ 諄T覇ア
1濡
:
閉齋曹而T瞬猟蕊
灘
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爾~~鷺
椰
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F
Am7
|
340「
il:〕lli;:li:i;:Iil;'~~~~
Fぉ
eN∝3/20/82‐ALC″2016聴繭喩認
LABORATORIES PRIVATE
lStatus:
rDeferred
I
Lic.No/Dttα09100646561Detr
07.02.2017
開肝獅15648鷹高:
RLA File
:09/24/040/00497/AM17/
Decision : Deferred
F雨
而画面而
貯
蕊報配冊
~圏
獅F藤
~諄
落
~~
菫辞面璃ざ
~~~~~――
―
一――
122/24/040/00101/AM17/
:01/82/050/01452/AM17/
lDecision: Deferred
PaけName:SUN
PHARMACEUTICAL
INDUSTRIES LTD.
342臨扁蔦:獅戸蹴蕊:覇蔦I「
:Lic.No/Date:0510401582 1Defer
108.02.2017 1Date:24.012018
becision : beferred
## Case No.:107/1/82‐
ALC4/2017
ADVANCE FESEARCH
ILAB AND EDU LTD
:01/82/050/01461/AM17/
する
1蕊需口面5655障縣蔦
: Deferred
l iCase No。:116/1/82‐
| :ALC4/2017
File
|
IDate:24.01.20181
|
ｄ
Ｓ
ｔ
ａ
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IDeferred
I
IRLA File
:ZZ/Z4/υ ttυ /υ υlυ ,/AIVl1/′
IDecision:Deferred
―
:01/82/050/01476/AM17/
## Case No.:122/1/82-
Status:
Deferred
２
８
Ｎ
ｏ
。
‥
‐
２
州
F
RLA File
:31/83/040/00168/AM17/
一
３
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６
一
３
４
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甲
:続
Lα″m7
|
|:霊路営ざ
U書繊だ
ACEA 鱚而~浮静~
Lic.No/Date10510402739 1Defer
129.05.2017
Date:24.01.2018
348「HQ File
:01/82/050/00597/AM18/
間図蔦
2ハmy~
ALC4/2017
13.12.2017
Lic.No/Date:2210015738
23.06.2017
faseNQ`り
6慇2‐ALC42m7mぶ
置
せ品
: IPHARMACEUTICALS
鱚而
∫ナ
:Lic.No/Date:3H0066602 1Defer i
IDate:24.01.20181
・
-1-一
一
|
I lDecision : Deferred
No。:27/6/82¨ ALC4/2017:ParりNameiCLEAN
iSCIENCE AND
|
|
「
Decision: Deferred
―
而
|
|
:01/82/050/00602/AM18/
Decision: Deferred
Ｆ
Ｌ
Ｆ
Ｉ
ALC4/2017
jfarty Name:DEEPAK
iNOVOCHEM
lrBcnNor.ocrEs LTD
I
l::2:'Fま
8/82-T孵瀬
~丁
1習器α
3面∞“Ы
7睡ち
4劇2∝8
1面Q File
RLA File
|:01/82/050/00724/AM18/
::31/83/040/00051/AM18/
1器疏
5υ006“ハ
my ttλ鵬
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1諾
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躙而
賠慧罰再靡
T~・1鼎肝面14813~臨蕊
1曇[IIIFII!iliil:filillJ‖
reF脳蹴蠣
LtteiS開邸
ittkl11:Sll
F「
IParりNameiCIPLA
IL
IMITED.
ase No.:40/6ノ82-ALC4/2017
/
IHQ File
| 13aseNo.:46/6/82-ALC4/2017
Name:GLENMARK Mcet No/Date:8/82-
rStatus:
l
lpsAnuecpurlcAls LTD., ltrc+tzott
lApproved i
1 113.12.2017
1習器α“Ю制
46811
Ｆ
‐
３
５
４
‐
IHQ File
I lDecision : Deferred
!~~~lA__、
γ "′
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T AJハ
A■‐
l:ss
|:01/82/050/00577/AM18/
lN-cqzon
lDeferred
113.12.2017 1
HQ File
:01/82/050/00610/AM18/
じ面百~~~~~~~薄
3評
:酔F5」T而習嚢曹蔦蕊
:03/94ィ040/00295/AM18/ i31.07
FCaseL議3'轟】_ALC42017
|
|
Paty Name:SHARP MINT
LTD.
IRLA File
105/24/040/00194/AM18/
Defer
Date:24.01.2018
Lic.No/Date:0510403559
101.08.2017
而~聞
暉驚
~TttFぼ「
観器
3泥剛∞:蕊戸剛靡ζ
lmν FM甲彎臨4∝洲
8
lDecision: Deferred
ParりName:KOPRAN
RESEARCH
Mcet No/Datc:8/82¨
ALC4/2017
13.12.2017
359日HQ Flle
:01/82/050/00665/AM18/
## Case No.:95/6/82‐ ALC4/2017
Lic.No/Date:0310815033
04.08.2017
ParサName:NEOGEN
ICHEMICALS LIMITED
|
Defer
Date:24.01.2018
:01/82/050/00706/AM18/
Lic.No/Date:0310815082
09.08.2017
:03/95/040/00036/AM18/ 111.08.2017
Lic.No/Date:0310815140
Status:
Deferred
Defer
Date:24.01.2018
HQ File
:01/82/050/00678/AM18/
RLA File
:03/95/040/00393/AM18/
Mcet No/Date:8/82‐
ALC4/2017
13.12.2017
Lic.No/Date:0310815158
16.08.2017
獅~
Defer
Date:24.01.2018
Party Name:LUPIN LIMITED lMeet No/Date:8/82-
師
‐
ICaseNo.:111/6/82-
彎
卜饉Ш I
lDeferred
I
IRLA File
IHQ File
IP釘サName:P.K.
PHARMATECH PVT LTD IALC4/2017
:13.12.2017
IRLA File
Paty Name:USV PRIVATE
ILIMITED)
No。:108/6/82-
Ｆ
Ｉ
Ｉ
響
:HQ File
:01/82/050/00681/AM18/
IRLA File
1103/95/040/00341/AM18/
Deferred
薇τ瞬濡扁
「
:ALC4/2017
113.12.2017
Decision: Deferred
」
―
―
―
~ |
367
IMcet No/Date:8/82-
lALC4/2017
113.12.2017
1蹴辮α“Ю譴
5337
1勝淵器:陰鮮―
・望翌里凩
.01.2018
lru.e rite
i:03 19 5 / 040 / 00421 / AMl I I
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′ο
1鶉署織D
'Status:
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脇聴話∴五lm7 諸ぶ辮α∞Ю尉
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4劇2∝81
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PHARMACEUTICAL
||
lrNousrruss LTD.,
File
諄鮮纂
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4037"B誰ち
4,2∝81
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iDecision: Deferred
8器
OCHEM(N〕
→PVT.1借
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ソ
ｄ
Ｓ
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1
:01/82/050/00655/AM18/ :Ю 5/24/040/00220/AM18/、__′l?l翌17… …___― ―
t― 一___1
蜘Decisim河樋∞m耐範e deciddわm:LI器
服
』臨
5器
耐洲°
邸
D/o PharmaceuJcals forwarded O.M.Nd `
iSeptember′ 2016′ uploaded at the end of these rninutes or as apphed by the firm i
1酬糖[よ鳳ζ
:11朧糧』鷲rdm∞“∝腱d叫朧mcessa嘔
:
:
ICase No.:138/6/82-ALC4/2017
1HQ File
101/82/050/00708/AM18/
RLA File
:04/24/040/00108/AM18/
ILic.No/Datc:0410163467 1
128.08.2017 1
Decision : The Committee decided to ratify norms based on the recommendation of
D/o Pharmaceuticals forwarded O.M. No3501L1L0212016-Pl(Norms) dated August,
2OL6, uploaded at the end of these minutes or as applied by the firm whichever is less
under para 4.07 of HBP Vol.l. RA concerned may take necessary
decision of Norms Committee.
action as per
」
|~咄
面
「
14赫誦虚蕊
諦響
鶉
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難
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1辮需まぬ
1081Йめ
3壺現ふ五
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一
rDecision :Deferred
: FaseNo■
132/6/82‐ALC42017『1官Name:MttDISPRAY_ rF夕贅,PPぃ
182-
l.-.l"'""
tlv"tJ2tv'o2-^!v!''v,
iloiicii*rozuES pvr. LTD. t;;i;^i;rw'u/o'-
Irz.rz.zon
l37s i
i
I
Jnq rir.
-
IRLA Fir"
- --lLt"N"/D"t"o3 ro8rs4l6
TI
Z/
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Name:STRIDES
IMeet No/Date:8/82‐
:ALC4/2017
113.12.2017
n /s2050/00?0rAM i87---* @'-
lzs.ot.zort
IDecision:丁he Commttee decided to ratify norms based on the recommendation of
忙em No.1
Aerodini 100 mcg inhaler(200md)With 58 mcl aerosolvalve and 19 ml aluminium can.
port item No.2
100 mcg HFA inhaler (200md) with 58 mcl aerosol valve and 19ml
luminium can.
respect of export product 3, the RA concerned may calculate the qty. of impot item
prorate basis as per the export item at sl. No.2 above & take necessary action as
. For export of 1 No. Inhaler
58 mcl Aerosol Valves
19 ml Aluminium can
As per packing policy
0.48mm OD Actuators with Dust
18.20 gms.
l rl,l 12 -tetrafl uo roethance (HFA
134A Propellant
. For export of 1 No. Inhaler
58 mcl Aerosol Valves
19 ml Aluminium can
As per packing policy
0。48mm OD Actuators with Dust
18.20 gms.
l rl rl r2-tetrafl uoroethance (HFA
134A Pro
lRer decision of Norms Committee.
TANげ
環
爾
『
而
~邪
面
孵
Amν l総鼎α瓢
0042"7「~
/乙
Imnort items
■
■
Salbutamol
0。02gms
2.
As ner Dackins nolicy
3.
As ner nackins nolicv
4.
5。
Imnort items
■
■
Budesonide
0.02gms
2.
As ner packins policv
3.
As ner packins policv
4.
5.
Ｆ
Ｉ
Ｉ
Ｉ
Ｉ
ICaseNo。:92/6ノ82‐ALC4/2017
|
「
377 Decision:The Committee decided to ratify norms based on the recommendation of
lD/o Pharmaceuticals forwarded O.M.No35011/864/2015-PI(Norms)dated 10th
鰤熙盟撥僣
i‖1鸞精品酬t蹴趙響
叩マ |
肩
脇
|:
)ecision : The Comn
r/o Pharmaceuticals 1
nder:
ヽ
ittOe deOided to ratify nortts based on‐ the recommendati●h of
lorWarded olMI N。35ol1/94/20161PI(INprm5)dated July′
2016′ as
Ettport ttё m
Qntv.
lm10rtltem
Qnty.
Lumefantrine
lkg
(DIBUttYLA～りNE 1 lⅥIAttHYL)=2′ 7=
DICH■ORO141FLUOREN
M[THANOL(pDA)
o.869Кg
RA concerned may take necessary action as per decision of NC.
剛瓶;靡蔦T~~匿蕩需蕊高藤話
:;
I)eclslon:Deferred
## Case No.:150/6/82-
1蒻曰ふ蔦I「
~囲
酉獅而Defer
Date:24.01.2018
″
瞥‖ …
LIFECARE PVT.LTD.
ｄ
ま
Ｏ
Ｖ
Ｓ
ｔ
ａ
ｔ
ｕ
柳
File
File
|:04/24/040/00HO/AM18/
jDecision : Deferred
饉
01鮮
靡Ⅷr町師¬
113.12.2017
「甲渕=孵鶉野
'I狩
‖纂
i o".irim ioJ""""o
[悪思
11「
~~~
3821器肌
5υ0072νAmν l跳ち鵬υ
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2210m5767認蕩蔦蔦
|
閣漑奢五b赫1瓶131
叩写再
諦W面雫締
「
……
tify norms based on the recommendation of
tify norms based on the recommendation of
.M. No35011/421/2016-Pl(Norms) dated
rninutes or as apphed by the firrn whicheveris
〕oncerned may take necessary action as per
「F辮面F~押琴ぽ
「丁諄郷ぽ
"¨
lStatus:
iApproved
1
―
賀
5田蕊薦蕊
「
瑶珈 i戸囲需両面
け
|
lpecision:peferred
tstatus:
,Approved
Decision : The Committee decided to ratify norms based on the recommendation of
D/o Pharmaceuticals forwarded O.M.No350Ltl349/2077-Pl(Norms) dated
December, 2OL7, uploaded at the end of these minutes or as applied by the firm
necessary
whichever is less under para 4.07 of HBP Vol.l. RA concerned may take
action as per decision of Norms Committee.
3861
西P高而而面漸可1蔦語翻評雨
剛蜃
lstatus:
IjDeferred
イタ
ICase No.:143/6/82‐
File
|:01/82/050/00713/AM18/
「霰鑑賛
:濯絣缶
D
iRLA File
iCase
「鯰酬腺m婚‖纂
||
1助ち刷:OЮ0148/AMlν
1蹴辮α期∞““
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「
::01/82/050/00648/AM18/
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i:05/23/040/00217/AM18/
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語調需轟0403934臨
iT
簿Q HL
「
| |
縣
|
|
T
59
.01.2018
闘
満
衝iTAN~
ILABORATORIES PVT.
|
3901:,11;::lllililAM18/
07.09.2017
Decision : Deferred
一
２
．
冊
雨
甲
Defer
Date:24.01.2018
:05/23/040/00233/AM18/
1両ゞm:beferred
IPaty Namc:YASHO
INDUSTRIES PVT.LTD.
:
剛鸞鳳「翻F「1濡戸
雨而
f
ろ釘
l3s8lHqFii;
:RLA File
:ALC4/2017
:13.12.2017
B鳶ち
4劇洲
81
i
l:01/82/0s0/00646/AMl8/
I iD..ttt", t Deferred
1貯淵
1/6/82‐
IMcetNo/Dtte:8/82- iStatus:
賠λ
ttυ 00462晨mν
IDeferred
i
|
File
:01/82/050/00642/AM18/
Pa=y Name:STRIDES
ISHASUN LIMITED
IRLA File
1:0412410401001 I 2/AM I 8/
1造き
]別rtC8/82¨
lor.os.zor z
iDecision: Deferred
rtte N∝η 682‐ALC伽
71鵠
柵
:器
LぶT
I
、
|
bsz
|″
41早9119
i
lDecision: Deferred
1鷺λ乳OЮ0480/AM18/
Defer
Date:24.01.2018
|
@
D..tyN;*slorECH--
i
IOPHTHALMICS PVT LTD
ir
|
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I面扉
1徴
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了
ist"tu*
l,lpproved
I
囮
百ぶ話蔦
395 Decislon:丁he Committee decided to ratify norms based on the recommendation of
Dlo Pharmaceuticals forwarded O.M. No35011/18112077-Pl(Norms) dated 24th
November, 20L7, uploaded at the end of these minutes or as applied by the firm
1鵬
胤
寵酬
需
開1%器
駆
ふ跳∬
:翼ぎ
山
曖Sted to calctte
Ｆ
・
甲
酉
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閻
汀
貯‖
酬
秘
鵬
脇
5υ∞
“
4ハⅢV Amy l悧
鼎
α囲飢
“
20B誰
ち4劇2∝8
396 Decision:丁he Committee decided to ratify norms based on the recommendation of
D/o Pharmaceuticals forwarded O.M.No35011/102/2016‐
PI(Norms)dated August′
2A!6, 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
lof Norms Committee.
## Case No.:71/6/82‐
「
IPaty NameiSTRIDES
ド
HAsw Ы
M「ED
購危鵬
0/00123ハmν
: The Committee decided to ratify norms based on the recommendation of
7。 Pharmaceuticals forwarded O.M.No35011/155/2016-PI(Norms) dated
ber,2OL6, uploaded at the end of these minutes or as applied by the firm
ichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary
ion as per decision of Norms Committee.
Mcet No/Date:8/82-
ALC4/2017
13.12.2017
Lic.No/Date:0410163536
19.09.2017
:01/82/050/00641/AM18/
ノぢ
No。:131/6/82‐
1綿島掲
50Ю070VAM13
: Deferred
ヘ
2010′ for the export item″FELODIPINE ER 5MG.TAB.86.25KGS&10MG.TAB.172.50KG
as under:
lmport ltem
Qty.
FELODIPINE USP
10.OMG ttABS
10.2
RA concerned may take necessary action as per decision of NC.
S′′
~~lCaSeNo.:4ノ
7r82-ALC4/2017
Pa●y Name:CATAPHARMA
CHEMICALS PVT.LTD.
Meet No/Date:8/82‐
ALC4/2017
13.12.2017
Lic.No/Date:3110066877
20.09.2017
Defer
Dateiz{.0l.2018
Mcet No/Date:8/82-
ALC4/2017
13.12.2017
## Case No.:89/6/82¨ ALC4/2017
PartyName:PCL OIL &
SOLVENTS LTD.
Lic.No/Date:0510404050
20.09.2017
## Case No.:90/6/82‐ ALC4/2017
Pa」けName:PCL OIL&
SOLVENTS LTD.
1鷺ち鵬υ
00259晨M「
Mcet No/Date:8/82-
ALC4/2017
13.12.2017
101/82/050/00660/AM18/
Lic.No/Date:0510404051
120.09.2017
Date:24.01.2018
Ｆ
Ｌ
障
―
ICaseNo.:97/6/82‐
ALC4/2017
1器星児
5υ00667AMlν
Mcet No/Date:8/82‐
ALC4/2017
13.12.2017
RLA File
:07/24/040/00166/AM18/
Party Name:GLOBAL
ICALCIUM PRIVATE
LIMITED,
Lic.No/Date:0710112175
121.09.2017
Date:24.01.2018
lDecision:
Ｆ
Ｌ
ド
ー
Mcet No/Date:8/82‐
ALC4/2017
13.12.2017
瞬漁猟
‐
Meet No/Date:8/82-
ALC4/2017
13.12.2017
rStatus:
rDeferred
Parfy Name:STRIDES
SHASUN LIMITED
Zワ=
lLic.No/Oate :0410163 547 lDefer
HQ File
File
:01/82/050/00726/AM18/
1/83/040/00032/AM17/
No.:87/6ノ82‐ALC4/2017
Name:MEGHMANI
LTD,
113島掲50/00657/AM18/
l:0 | I 82 I 050 I 0064s/AM I 8/
l:04 124 I 040 / 00124 I AMrts I
121.09.2017
lDate:24.0 I .201 8
ParりName:UPL
LTD.(FORMERLY UNITED
PHOSPHORUS LTD)
RLA File
Meet No/Date:8/82-
:01/82/050/00689/AM18/
ALC4/2017
13.12.2017
Lic.No/Date:0310815884
121.09.2017
ICase No.:125/6/82‐
灘淋閻器玉
V
Mcet No/Date:8/82-
ALC4/2017
13.12.2017
406鵬星児
5υ∞の
5ハmν~
4071HQFile
P釘りName:CADlLA
HEALTHCARE LTD
Mcet No/Datc:8/82‐
ALC4/2017
13.12.2017
)ate:24.01.2018
## Case No.:118ノ6/82‐
:01/82/050/00688/AM18/
RLA File
:03/95/040/00446/AM18/
Mcet No/Date:8/82-
ALC4/2017
1312.2017
Lic.No/Date:0310815895:Defer
Date:24.01.2018
Name:METROPOLITAN
EXIMCHEM PRIVATE LTD.
## Case No.:122/6/82‐
:01/82/050/00692/AM18/
Party Name:RELIANCE
INDUSTRIES LTD
RLA File
:03/95/040/00246/AM18/
RLA File
:03/95/040/00371/AM18/
鱚
:8/82‐ ~~~1需
源~
Mcet No/Date:8/82‐
ALC4/2017
13.12.2017
Lic.No/Date:0310815896 1Defer
## Case No.:129/6/82-
Pa●y Name:RELIANCE
INDUSTRIES LTD.
:01/82/050/00699/AM18/
Date:24.01.2018
ろζ
ヘ
Ｆ
Ｌ
Ｆ
Ｉ
No.:119/6/82-
HQ File
Ｆ
猟
ド
ー
Name:USV PRIVATE
(FORMERLY USV
暉霊淵″
7″百~~
lr-narrroy
IB.22∝7 1
B鮨ち側川
8
Ｆ
Ｌ
ド
ー
戸閉図蕊蕊戸囲辮側∞柁賀
6
ICase No.:70/6/82-ALC4/2017 1Partt NameiCAPLIN POINT IMcetNo/Date:8/82‐
LABORATORIES LTD。, IALC4/2017
Ｆ
Ｌ
Ｆ
Ｉ
Ｆ
Ｌ
ド
ー
Ｆ
Ｌ
Ｆ
Ｉ
Ｆ
Ｌ
ド
ー
## Case No.:96ノ6/82‐ ALC4/2017 Party Name:NEOGEN
1器島掲
50Ю0666晨my ttλ発
OЮ0403ハMν
障淵%脱‐
|
1器3泥5υ0068yAMlν
Lic.No/Date:0310815952 1Defer
/′
鵬星児
50Ю“
"ハmy~賠λ
ttυO“
"晨mν l
3.12.2017
:01/82/050/00640/AM18/
No.:3/7/82-ALC4/2017
File
No。:117/6ノ82…
17西File
:01/82/050/00687/AM18/
1/83/040/00080/AM18/
CHEMICALS LIMITED
Party Name:MEHK
CHEMICALS PVT LTD.
File
No/1Datc:8/82-
13.12.2017
No/Datc:8/82-
3122017
No.:73ノ6/82‐ ALC4/2017
iCase No。:114/6/82‐
IALC4/2017
lHQ File ~~~~
|:01/82/050/00684/AM18/
猛霊脇#6″
82
:
IHQ File
101/82/050/00686/AM18/
Party Name:NEOGEN
ICHEMICALS LIMITED
RLA File
:03/95/040/00474/AM18/
1翻TT~1濡
臨IttI
IDecision:
一
４
２
０
## Case No.:152/6/82…
ALC4/2017
HQ Flle
:01/82/050/00722/AM18/
~RL全
甲9^____ LicN空
lα22Ю015780藤おr
|:22/24/040/00038/AM18/ 127.09.2017
Date:24.01.2018
Decision :
「「観¨跡
ALC4/2017
P訂りName:CLEAN
iSCIENCE AND
iTECHNOLOGY PVT.LTD.
lStatus:
lDeferred
421
IHQ File
101/82/050/00723/AM18/
所淋鮨扁
譜∬器α
3百而
`蘇
Defer蔦
201
lDecision :
~~~ICaseNo.:1/8ノ
82‐ALC4/2017
控き淵ναν
82
113.12.2017
焉麒
i727/AM18/
Lic.No/Date:0510404243
:05/24/040/00301/AM18/ IH.10.2017
: The Committee decided to ratify norms based on the recommendation of
D/o Pharmaceuticals forwarded O.M.No35011/52/2017-PI(Norms)dated
25th
:ember, 20L7, uploaded at the end of these minutes or as applied by the firm
is less under para 4.07 of HBP Vol.l. RA concerned may take necessary
ion as per decision of Norms Committee.
422
か
Name:NEOGEN
iCHEMICALS LIMITED
IRLA File
IMcet No/Date:8/82-
IALC4/2017
113.12.2017
127.09.2017
一
|
1柵満酬絆
L
File
1導:I為ed i
「
~~~|
| |
|
ハ
Manual Cases
## Case No B‐ 01
M No08ノAM‐ 18
Date 13 12 2017
Mノs Fresenius Kabi Oncolo9y Ltd
F‖e No 01/821050ノ00629/AM 17
RLA No 05/23/040ノ00168/AM17
Adv Auth No 0510399049 dated l1 07 2016
n of norms regarding amendment in.import item
"Docetaxel Anhydrous" to "Docetaxel Trihydrate" considered in the meeting. lt is decided to refer
the matterto Deptt of Pharma fortheir comrnents RA may take necessary action accordingly
## Case No B-02
M No 08ノAM‐ 18
Date 13 12 2017
Mノs Fresenius Kabi Oncology Ltd
F‖e No 01/82/050ノ00229/AM 17
RLA No 05/23/040/00063/AM17
Adv Auth No 0510398543 dated 18 05 2017
m "Ethanol Absolute' as synonymous to
;OenyOrateO Alcohol" considered in the meeting and it is decided to allow "Ethanol Absolute/
Dehydrated Alcohor' RA may take necessary action according:y
## Case No B-03
M No08ノAM‐ 18
Date 13 12 2017
Mノs Jub‖ant Generics Ltd
File No 01/82/050/00085/AM 17
RLA No 05/23/040/00471/AM 16
Adv Auth No 0510397645 dated 18 02 2016
to defer it as comments from Deptt of
Pharma is awaited.
## Case No B‐ 04
M No 08ノAM‐ 18
Date 13 12 2017
IrI/s. DSM Sinochem Pharmaceuticals Ltd
File No 01/83/050ノ00914/AM 08
RLA No 22/24/040/00028″ ヽM08
Adv Auth No 2210006954 dated 07 08 2007
questofthefirmforcorrectionofnormsunderpara
Norms Committee.
4.7 as per agenda. lt was observed that there was an error in terms of the route and
corresponding inputs. The committee decided to correct the norms on the recommendation of
department of
Pharma forwarded vide their OM.No35OtLl343l2}t7-Pl(Norms) dated
November, 2017, 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
M/s. DSM Sinochem Pharmaceuticals Ltd
F‖e No 01/83/050ノ00541/AM 08
RLA No 22/24/040/00015/AM08
Adv Auth No 2210006806 dated 18 06 2007
## Case No B‐ 05
M No08/AM-18
Date 13 12 2017
7ノ
Decision : The committee considered the request of the firm for correction of norms under para
4.7 as per agenda. lt was observed that there was an error in terms of the route and
corresponding inputs, The committee decided to correct the norms on the recommendation of
department of Pharma forwarded vide their OM. No35011/343/2017-Pl(Norms) dated November,
2017, 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 Norms
Committee.
## Case No B‐ 06
M No08/AM‐18
Date 13 12 2017
Mノs DSM Sinochem PharmaceuJcals Ltd
F‖e No 01/82050ノ00528/AM 07
RLA No 22/24ノ040ノ00123/AM07
Adv Auth No 2210005750 dated 10 07 2016
D""ision : The Committee considered the request ofthe firm for correction of norms under para
4.7 as per agenda. lt was observed that there was an error in terms of the route and
corresponding inputs. The committee decided to correct the norms on the recommendation of
department of Pharma forwarded vide their OM.No35011/343/2017-Pl(Norms) dated November,
2017, 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 Norms
Committee.
M/s Saurav Chemical Ltd
F‖e No 01/82/050/00787/AM 16
RLA No 22/24/040/00006/AM16
Adv Auth No 2210015251 dated 10 06 2015
## Case No B-07
M No08/AM‐ 18
Date 13 12 2017
regarding correction in descmption of import tem from
Decision: The request of the firm regarding correction in descnptlon oI lmpon llem Trom
,,Levofloxacin e Acid" to "Levofloxacin etfry Estef' for export product Levofloxacin Hemihydrate
. lt is decided to refer the case to
of Pharma for their comments.
## Case No B-08
M No08/AM‐ 18
Date 13 12 2017
M/s Tide:ndust‖ es Ltd
F‖e No 01/82/050ノ00531ノAM 16
RLA No 34/24/040ノ00138/AM15
Adv Auth No 3410040551 dated 15 09 2014
ffitherequestofthefirmforcorrectionofnormsunderpara
Committee.
4 7 as per agenda lt Was obServed that there was an error in earlier minutes lt iS decided to
correct/a‖ OW the norms on repeat basis as per the ea‖ ier decision of the Norms Commlttee
Meeting No 12/82 dated 21 06 2011(caSe n0 35/12ノ82/ALC4/2011)uploaded at the end ofthe
minutes RA concerned may take necessary actiOn in the matter as perthe decision ofthe Norms
M/s KL」Plasucizers Ltd
F‖e No 01ノ82/050/00071/AM 16
RLA No 05/23/040ノ00176〃ヽM14
Adv Auth No 0510361463 oated 01 08 2013
## Case No B-09
M No08/AM‐18
Date 13 12 2017
フと
Decision:The request ofthe lrm for correction in descnption Of expon pЮ duct considered in the
meeung tt is decided to correct the export product KANATOL400(N)to KANATOL‐
400(M)
(MIXED ALCOHOL PHTHALATE(C4-C6)RA concerned may take necessary action in the matter
as perthe decision ofthe Norms Committee.
## Case No B‐ 10 1M/s KL」
Plaslcizers Ltd
M No08/AM-18 1F‖ e No 01ノ82ノ050ノ00141/AM 16
Date 13 12 2017 1 RLA No 05/23/040/00039/AM16
Adv Auth No 0510394196 dated 12 05 2015
Decision: The committee considered and decide to correct the import item from "Phthalic
Andydride" to "Phthalic Anhydride". RA concerned may take necessary action in the matter as per
the decision of the Norms Committee.
## Case No B‐ 11
M No08/AM-18
Date 13 12 2017
Mノs Fermenta BIotech Ltd
F‖e No 01ノ82/050ノ01106/AM 17
RLA No 03/94/040/00817/AM17
Adv Auth No 0310809743 dated 13 12 2016
Decision:The request of the firm for amendmentin description of export product considered in
the meeting The Committee decided to ca‖
for information based on the recommendation of
D/o Pharmaceuticals fomarded O M No35011/761/2015-PI(Norms)dated 07 12 2017′ uploaded
atthe end ofthese minutes and deferred the case
## Case No B‐ 12 1Mノs CadHa Pharmaceulcals Ltd
M.No.08/AM-18
| rite No. Oil9A}SOIOO22Z1AM 17
Date 13 12 2017 1 RLA No 08ノ24ノ040/00069/AM17
AdvAuth No 0810137950 dated 19 05 2016
Decision: The request of the firm for revision of the norms considered in the. rneetingrend decided
to maintain the status-quo. RA concerned may take necessary action as per decision of Norms
Committee.
## Case No B-13
M No08/AM-18
Date 13 12 2017
Mノs」B Chemicals&Pharmaceulcals Ltd
F‖e No 01/82/050ノ01441ノAM 16
RLA No 03ノ94/040/00405/AM16
Adv Auth No 0310798727dated 08 09 2015
Decision:ThecommitteedecidedtoamendthenormsaSpertn@
Deptt. of Pharma vide their oM No.3501 1/804/201S-lP(Norms) daled 2s.01.2016 as under:
Qty A‖ owed per100
Cetylpyridinuim Chloride and
Benzydamine Hydrchloride
アタ
RA concerned may take necessary action as per decision of Norms Committee.
lsomaL ST¨ M
249.526 gm
antiseptic Lozenges Sugar
Free. Each Lozenge contains
Cetylpyridinium Chloride 1 .00
mg, lsomalt ST-M 2591.86 mg.
Net Content Cetylpyridinium
chloride 5.964 Kgs, lsomalt
ST―M15456.567
## Case No.B‐ 14 1Mノs.J.B Chemicals&Pharmaceu‖ cals Ltd
M.No.08ノAM-18 1 File No 01/82ノ050/00423ノAM 16
Date 13.12.2017 1 RLA No.03ノ94ノ040ノ01084/AM15
Adv.Auth.No.0310793953 dated.18.02.2015
Decision: The committee deliberated on the matter in the presence of technical representative of
Deptt. of Pharma and decided to amend the norms as under:
RA concerned may take necessary action as per decision of Norms Committee.
Export item
Qtv.
lmport item
Qtv. in om
Difflam Sugar Free Lozenges
in Raspberry/ Eucalyptus &
Menthol/Honey & Lemon/,
Orange/Double Mint Flavours
100 lozenges
Benzydamine
hydrochloride
0.306
Cetylpyridinium
Chloride
0.135
lsomaI ST― M
258.600
Difflame AAA Sugar Free
Lozenges in
BlackcurranUHoney &
Lemon/Eucalyptus and
menthol Flavours
100 lozenges
Benzydamine
hydrochloride
0.306
lsomak ST― M
257.00
## Case No.B-15
M.No.08ノAM-18
Date 13.12.2017
Mノs.Enaltec Labs P Ltd
F‖ e No.01ノ82ノ050ノ00256ノAM 18
RLA No.03/94ノ040ノ01102/AM17
File No.01ノ82ノ050ノ00520ノAM 18
RLA No.03ノ94ノ040ノ00191ノAM18
File No.01/82ノ050ノ00097ノAM 18
RLへNo.03ノ94/040ノ01103/AM17
Adv.Auth.No.0310811 794 dated.14.03.2017
Adv.Auth.No.0310813995 dated.14.06.2017
Adv.Auth.No.0310811 751 dated.09.03.2017
Decision: The committee decided to correct the description of import items of following three
advance authorisations as under:
フタ
RA concerned may take necessary action as per decision of Norms Committee.
Advance Authorization
No. & date
4-Fluoro-alpha-(2-methyl -1-
oxopropyl)-gamma-oxo-N,
betadiphenyl benzene butanamide
4-Fluoro-alpha-(2-methyl -1-
osopropyl)-gamma-oxo-N,
betadiphenyl
benzene
buta namide
0310811794
dt 14 03 2017
4-Fluoro-alpha-(2-methyl-1-
oxopropyl)-gamma-oxo-
N,betadiphenyl
benzene
butanamide
4-Fluoro-(alpha)-(2-methyl-2-
oxopropyl)-gamma-oxo-N,(beta)-
diphenyl benzene butanamide
0310813995
dt 14 06 2017
2[3(S)-13-[2-(7-Chloroquino:ine-2‐
YL) Ethenyl]phenv113-
Hydroxypropyl] Benzene-2-
2-{2-3S-3′ 2′ 7-chloro‐ 2-
quinO‖ nyl)― (ethenylphenyI)-3‐
hydroxy propyl)pheny1 2
0310811751
dt 09 03 2017
M/s Camphor&A‖ ied Products Ltd
F‖e No 01/82/050/00568ノAM 17
RLA No 03/94/040/00114ノAM17
Adv Auth No 0310806356 dated 18 07 2016
## Case No B‐ 16
M No08/AM‐18
Date 13 12 2017
DJcisiora Ttle, comlnittee considered the request of the firm regarding correction in the description
of the export product. The committee decided to correct the description of export product from
"Astromusk Conecentrate (Astromusk content: 100%)" to "Astromusk (S) (Astromusk content:
100%)'.
RA concerned mav take n
action as per decision of Norms Committee'
## Case No B‐ 17 1M/S DSM Sinochem Pharmaceulca:s Ltd
M.No.O8/AM-18
I rite No. 0'.1/82l050/00163/AM 17
Date 13 12 2017 1 RLA No 22/24/040/00015/AM17
Adv Auth No 2210015487 dated 01 06 2016
Decision: The Committee considered the request of the firm for correction of norms under para
4.7 as per agenda. lt was observed that there was an error in earlier minutes. The committee
decided to correct the norms as under:
RA concerned may take necessary action as per decision of No1rn{grnmIlgg
Export item
Qtv
lmport item
Qtv in KG
AMOXYCILL!N TRIHYDRATE
THROUGH 6去PA ROUTE
THROUGH ENZYMATIC
ROUTE
lKG
6‐AMINO PENIC!LLA
NIC ACID(6‐APA)
055
FORMIDASE
(ENZYME)
0005
D(―)P‐HYDROXY
PHENYL GLYCINE
METHYLESTER
0477
フす
From
To
Oι θ
F. No.350 11 17 57 1201 s-Pl (Norms)
Government of lndia
Ministry of Chemical & Fertilizers
Department of Pharmaceuticals
Udyog Bhawan, New Delhi,
Dated: 2, May 2016
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14
Case of M/s Sriam Labs Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O.No. 0118215011291AM-16/DES-
311282 dated the 16112115 vide which application from M/s Sriam Labs Pvt. Ltd. was
sent to this Department for fixation of norms under para: 4.7 tor the export of 1,3-
dimethoxy-5-[(E)-2-(4-methoxy phenyl)-1-ethenyl] benzene. 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 1kq Export
3,5-dihydroxy benzoic acid
0.99kg
2
Sodium borohydride
0.628kg
3
Triethvl phosphite
1:384kg
2.
This issues with the approval of competent authority.
(Raikumar)
Under Secretary to the Government oflndia
PH:-23071162
Directorate General of Foreign Trade,
Department of Commerce,
(Shri M.V. Singh, FTDO),
Udyog Bhawan, New Delhi
π
F. No.350 I I I 5481201 4-PI (Norms)
Government of India
Mirristry of Chemical &, Fertilizers
Udyog Bhawan,
New Delhi, the April, 2015
Office Memorandum
Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vo1.1) 2009-
14 Case of IWs. Anuh Pharma Ltd.
The undersigned is directed to refer to DGFT U.O.No.
Otl}2l50l622lANIL5|DES-31753 dated the 2lll0ll4 vide which an application
from IWs. Anuh Pharma Ltd was sent to this Department for fixation of norms
under parai 4.7 for the export of Betamethasone Sodium Phosphate. This
department has examined the matter and the following comments are furnished
under para 4.7 of Hand Book of Procedures (vo1.1) 2009-14-
S. No.
Import Item
Qty. Recommended kg/kg.
1
Betamethasone
0.78 kg/kg
つ
´
This issues with the approval of Director (PI).
(Barnali Khastgir)
Under Secretary to the Govemment of India
Phone- 23071162
'7a
J
ン
F. No.350 I 1 17831201 5-Pl (Norms)
Government of lndia
Shastri Bhawan, New Delhi,
Dated: July 14, 2016
Office Memorandum
Sub: - Fixation of norms - Application of M/s Encube Ethicals PvL Ltd.
The undersigned is directed to refer to DGFT U.O. No. A1/821050/01357/AM-16/DES-
3t1494 dated 1210112016 forwarding an application of M/s Encube Ethicals Pvt. Ltd. for
fixation of norms against export of (1) Myoflex Regular 10o/o,100 gm tube (2) Myoflex
Extra Cream 15o/o,100 gm tube (3) Myoflex Max, 100 gm tube (4) Ozonol Ointment
30 gm tube & (5) Ozonol Ointment 60 gm tube as API). This department has
examined the matter and the.following norms are furnished: -
Export ltem No. I Myoflex Regular 10o/o,100 gm tube
Export ltem No.2 Myoflex Extra Cream 'l5o/o,100 gm tube
″
Product to be Exported
Raw materials to be lmported
Description
Quantity
S.N
O
Description
Quantity per 100
tubes
Myoflex Regular
10o/o, 100 gm
tube (containing
Triethanolamine
Salicylate 1Ao/o
w/w)
100
tubes
Cetyl Alcohol NF(SpeziOI
C16ノKolliwax CA)
1000 gm
2.
StearylAlcohol
500 gm
3.
White Bees wax (white
wax)
100 gm
4.
Sodium Lauryl Sulphate
200 gm
5
Trolamine 99% Minimum
134.50 gm
6.
Lavender Oil
2.20 gm
7.
HDPE Plastic Tubes for
100 om
Relevant, As per
packing policy
Product to be
Exported
Raw materials to be lmPorted
Description
Qυan″fy
S No
Description
Quantity per 100
tubes
Myoflex
Extra Cream
15o/o, 100 gm
tube
(containing
Triethanolami
100
tubes
Cetyl Alcohol NF(SpeziOI
C16ノKolliwax CA)
1000 gm
2.
Stearyl Alcohol
500 gm
3.
White Bees wax (white wax)
100 gm
4.
Sodium Lauryl SulPhate
200 gm
5.
Trolamine 99% Minimum
801.219m
ツ
ne Salicylate
15%w/w)
6.
Lavender Oil
2.20 om
7.
HDPE Plastic Tubes for 100
0m
Relevant, As per
packinq policv
-2-
Export ltem No. 3 Myoflex Max, 100 gm tube
Export ltem No. 4 Ozonol Ointment 30 gm tube &
Export ttem No. 5 Ozonol Ointment 60 gm tube
Product to be
Exported
Raw materials to be lmported
Description
Qυan″ケS.N
O
Description
Qυan″ry per
fοO rJbes
Myoflex
Max, 100 gm
tube
^./
(containing
Triethanolami
ne Salicylate
20o/o wlw)
100
tubes
Cetyl Alcohol NF(SpeziOI
C16/Kolliwax CA)
1100 gm
2.
Stearyl Alcohol
550 gm
3.
White Bees wax (white
wax)
110 gm
4.
Sodium Lauryl Sulphate
200 gm
5.
Trolamine 99% Minimum
1068.96 gm
6.
Lavender Oil
2.20 gm
7.
HDPE Plastic Tubes for
1009006D
Relevant, As
per
packing
policy
Product to be
Exported
Raw materials to be lmPorted
Description
Qυan″ly
S.N
O
Description
Qυan″ly
30 gm ftrbe
QuantitY
60 qm tube
8爾狙縄
711nl
O.18% w/wl
Phenol and
3.720/O w/w
Zinc Oxide).
100
樹絆E
Petrolatum yellow
USP
1818.60
gm
3637.20
gm
2.
Bees wax yellow
(Refined) USP
216 gm
432.00 gm
3.
Lanolin USP
260,70 om
521.40 gm
4.
lchthammol USP
8 70 om
17.40 om
5.
VVhite lⅥineral()il
519.60g“
1039.20
9m
6.
Origanum Oil
Red lmitation C
12.30 gm
24.60 gm
7.
Phenol USP
5.40 gm
10.80 gm
8.
Aluminium
Collapsible tube
30 sm or 60 gm
Relevant, As Per
packing PolicY
レ
F. No.3501 1/1 /201 6-Pl (Norms)
Government of lndia
Dated: 1 June,2016
Office Memorandum
## subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (vol.l) 2009-14
Case of M/s Suven Life Sciences Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82l50/0185/AM-
16/DES-3/'1653 dated the 1812t16 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
(1-Phenylmethyl)-lHJndeno[2,'l-b]Pyridine-6-Carbonitrile. 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. The import item is catalyst only for which no recovery or regeneration is shown.
The firm may be advised to elaborate the recovery of imported catalyst with
technical justification.
2.
(Rajkumar)
Under Secretary to the Government of lndia
PH- 23071162
お
\tE
F. No.3501 1/761 120'15-Pl (Norms)
Government of lndia
Room no.31o, B-wing, 3'd floor,
Janpath Bhawan, New Delhi,
Dated: December ,2017
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. 0118215011078/AM-16/DES-3/81
dated the 3t1112017 vide which an application from M/s Fermenta Biotech Ltd. was sent
to this Department 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.
(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: 23061562, Extn.269
田
Dated: June,2016
Office Memorandum
Case of M/s Shasun Pharmaceuticals Ltd.
The undersigned is directed to refer to DGFT U.O.No. 011821501125414M-
16tDES-3t1273 dated the 16t12115 vide which application from M/s Shasun
Pharmaceuticals Ltd. was sent to this Department for fixation of norms under para: 4.7
for the export of Gabapentin Tablets USP 600mg. This department has examined the
matter and the following norms are furnished under para 4.7 of Hand Book of
Procedures (Vol.l) 2009-1 4:-
DGFT is advised to call copy of Master-Batch formula from the firm'
2.
(Ralkumar)
Under Secretary to the Government oflndia
PH:-23071162
(shn M v singh,FTDO),
Udyog Bhawan,New Delhi
∂レ
F. No.35011 17641201 s-Pl (Norms)
Government of lndia
Room no.310, B-wing, 3'd floor,
Dated: November ,2017
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-
20 Case of M/s Fresenius Kabi Oncology Ltd.
The undersigned is directed to refer to DGFT U.O. No. 0118210501012721AM-
17IDES-3/1318 dated the 1611212015 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 Docetaxel lnjection Concentrate 160m9/8m1, 120m9/6m1, 80mg/4m1,
20mgl1ml. 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:-
For 1 60ms/8ml iniection:-
・
０
Ｓ
Ｎ
Export item
S.
No.
lmport item
Norms
Recommended
for 1000
iniections
Docetaxel
lnjection
Concentrate
160m9/8ml
DSC-9[4S,5R)-2-(4-
methoxyp henyl)-N-t-boc-p he nyl-
oxazolidine-5-carboxylic acidl
178.089ms
2
273.40kg
3
Ethanol Anhydrous
3.68Ltr.
For 120mq/6ml iniection:-
S
No.
Export item
・
０
Ｓ
Ｎ
lmport item
Norms
Recommended
for 1000
iniections
Docetaxel
lnjection
Concentrate
120m9/6ml
DSC-9[4S,5R)-2-(4-
methoxyphenyl)-N-t-boc-p he nyl-
oxazolid ine-5-carboxylic acidl
140gms
2
215.16kg
3
Ethanol Anhydrous
2.76Ltr.
8i
For 80mq/4ml iniection :-
・
０
Ｓ
Ｎ
Export item
S.
No.
lmport item
Norms
Recommended
for 1000
iniections
I
Docetaxel
lnjection
Concentrate
80mg/4ml
DSC-9[4S,5R)-2-(4-
methoxyphenyl)-N -t-boc-phenyl-
oxazolidine-5-carboxvlic acidl
93.289ms
2
143.44kq
3
Ethanol Anhydrous
1.84Ltr.
For 20mq/1 ml iniection:-
・
０
Ｓ
Ｎ
Export item
・
０
Ｓ
Ｎ
lmport item
Norms
Recommended
for 1000
iniections
1
Docetaxel
lnjection
Concentrate
20mg/1ml
1
DSC-9[4S,5R)-2-(4-
methoxyphenyl)-N t-boc-phenYl-
oxazolid ine-5-carboxylic acidl
23.329ms
2
35.86kg
3
Ethanol Anhydrous
0.46Ltr.
2.) This issues with the approval of competent authority.
(Parveen Kumar)
Phone: 23352298
Email: parveen. 1 9@gov.in
(Shri S.K. Panigrahi, Economic Officer, DES-Ill
Phone No: 23061562, (269),
Email: sk.paniqrahi@nic. in
駒
6l / 6>t 1 o
F. No.350 1 1 187 01201 s-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 0f M/s Fresenius Kabi Oncology Ltd.
The undersigned is directed to refer to DGFT U.O. No. 011821050/01503 &
01502/AM-17/DES-3/'1696 & 1701 dated the 191212016 & 221212016 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 Paclitaxel lnjection of 600m9, 300m9,
260m9, 150m9, 100m9 & 30m9. 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:-
For 600mq iniection (100m1):-
S.
No.
Export item
S.
No.
lmport item
Norms
Recommended
for 1000
injections
Paclitaxel
lnjection of
600m9/100m1
Kolliphor ELP.
53kg
2
Ethanol Anhydrous
49.74Ltr.
3
Silica Gel.
12.6k9
4
Cerrous Chloride
639ms
5
(4S, 5R)-2-(4-methoxy phenyl)-N-
Benzoyl-4-p henyl-oxazol id i ne-5-
carboxlic acid
705.69ms
6
1084.8k9
S"I
For 300mq iniection (50m!):-
)
6 l,4z r1@-
S.
No.
Export item
・
０
Ｓ
Ｎ
lmport item
Norms
Recommended
for 1000
injections
Paclitaxel
lnjection of
300m9/50m1
Kolliphor ELP.
26.5k9
2
Ethanol Anhydrous
24.87Ltr.
3
Silica Gel.
6.3k9
4
Cerrous Chloride
31.Sgms
5
(4S, 5R)-2-(4-methoxy phenyl)-N-
Benzoyl-4-phenyl-oxazol id i ne-5-
carboxlic acid
3.528k9
6
542.4k9
For 260mq iniection (43.7m1 in 50ml vial):-
・
０
Ｓ
Ｎ
Export item
・
０
Ｓ
Ｎ
lmport item
Norms
Recommended
for 1000
injections
1
Paclitaxel
lnjection of
260m9/50m1
1
Kolliphor ELP.
22.872k9
2
Ethanol Anhydrous
21.57Ltr.
3
Silica Gel.
5.46k9
4
Cerrous Chloride
27.39ms
5
(4S, 5R)-2-(4-methoxy phenyl)-N-
Benzoyl-4-p he nyl-oxazolid i ne-5-
carboxlic acid
305.769ms
6
470.106k9
For 150mq iniection (25m1):-
S.
No.
Export item
・
０
Ｓ
Ｎ
lmport item
Norms
Recommended
メ
6l , dz, 1o
for 1 000
inieCtiOns
Paclitaxe!
lnjection of
150m9/25m1
Kolliphor ELP.
13.25kg
2
Ethanol Anhydrous
12.44Ltr.
3
Silica Gel.
3.15kg
4
Cerrous Chloride
15.75gms
5
(4S, 5R)-2-(4-methoxy phenyl)-N-
Benzoyl-4-phenyl-oxazolid ine-5-
carboxlic acid
1.764kg
6
271.2kg
For100mg′16.7mlin 50ml宙al:‐
・
０
Ｓ
Ｎ
Export item
S.
No.
lmport item
Norms
Recommended
for 1 000
inieCtiOns
Paclitaxel
lnjection of
100m9/16.7m1 in
50ml vial
Kolliphor ELP.
8.851kg
2
Ethanol Anhydrous
3.333Ltr.
3
Silica Gel.
2.l kg
4
Cerrous Chloride
10.Sgms
5
(4S, 5 R)-2-(4-methoxy phenyl)-N-
Benzoyl-4-phenyl-oxazolid ine-5-
carboxlic acid
117.69ms
6
180.81 0kg
For30mg′ 5m:inieC■On:‐
∂キ
0/,42,, 1n
・
０
Ｓ
Ｎ
Export item
S.
No.
lmport item
Norms
Recommended
for 1000
injections
1
Paclitaxel
lnjection of
30mg/5ml
1
Kolliphor ELP.
2.65k9
2
Ethanol Anhydrous
2.482Ltr.
3
Silica Gel.
6609ms
4
Cerrous Chloride
3.39ms
5
(4S, 5R)-2-(4-methoxy phenyl)-N-
Benzoyl-4-phenyl-oxazolid i ne-5-
carboxlic acid
36.969ms
6
56.826k9
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
Email: sk. panisrahi@nic. in
W
″
F No 35011/217/2016-Pi(Norms)
Government oflndia
Ministry of Chemical&Fertilizers
竹
Dated: October,2016
Office Memorandum
Case of M/s Arene Lifesciences Ltd.
The undersigned is directed to refer to DGFT U.O.No. 011821501146214M-
16/DES-3/324 dated the 121712016 vide which application from M/s Arene Lifesciences
Saquinavir Mesylate. 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 may therefore be advised the firm to give complete technical details as per
Appendix-33.
(Ralkumar)
Under Secretary to the Government of!ndia
PH:-23071162
Directorate Ceneral of Foreign Trade,
Depanment Of Commerce,
(shn M v singh,FTDO),
Udyog Bhawan,New Delhi
」
F. No.3501 1/1 38/2016-Pl (Norms)
Government of lndia
Dated: August, 20'16
Office Memorandum
Case of M/s Optimus Drugs (P) Ltd.
The undersigned is directed to refer to DGFT U.O.No. 0118215012561AM-17/DES-
3/208 dated lhe 417116 vide which application from M/s Optimus Drugs (P) 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 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.) The import item no.1 i.e. 4,4-bis (chloromethyl) biphenyl does not match with the
process detail /chemistry furnished by the firm.
Revised process or description of import item may be given.
2.) Past production vis-d-vis actual consumption of all imported imported inputs duly
certified by Central Excise Authorities may be given.
2.
(Raikumar)
PH:- 23071162
io
F. No.3501 1 /1 01 12016-Pl (Norms)
Government of lndia
+q
Dated: August,2016
Office Memorandum
Case of M/s Strides Shasun Ltd.
The undersigned is directed to refer to DGFT U.O.No. 011821501130 & 129iAM-
17IDES-3/98 & 97 dated the 2315116 vide which application from M/s Strides Shasun
Gabapentin Tablets USP 600m9 & 800m9. This department has examined the matter
and the following norms are furnished under para 4.7 oI Hand Book of Procedures
(Vol.l) 2009-14:-
DGFT is advised to call copy of master-batch formula duly certified by their Q.C.
incharge for the export of gabapentin 600m9 tablets and 800m9 tablets.
(Rajkumar)
PH- 23071162
(Shri M.V. Sinsh, FTDO),
91
F. No.350"1 1/15412016-Pl (Norms)
Government of lndia
il*n''o
Dated: September, 2016
Office Memorandum
Case of M/s Strides Shasun Ltd.
The undersigned is directed to refer to DGFT U.O.No. 011821501182 & 183/AM-
17IDES-31184 &'t86 dated lhe 417116 vide which application from M/s Strides Shasun
Gabapentin Tablets USP 800m9 & 600m9. 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 copy of master-batch formula from the firm duly authenticated
by their Q.C. incharge.
(Rajkumar)
PH:23071162
9>
F. No.3501 1/1 58/2016-Pl (Norms)
Government of lndia
Shastri Bhawan, New Delhi,
Dated: March 15,2017
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. 01/821050/00331/AM-17/DES-
3/248 dated the 08/07/2016 vide which an application from M/s Apex Pharma. was
sent to this Department for fixation of norms against export of Selamectin 6% SPOT
ON (each pipette containing Selameetin 6% W/V or 60 mg/ml).
2.. The matter has been and following additional information, needed for working out the
requirement of bulk drugs for the export product, may be called for from the applicant: -
i. Quantity of Selamectin 6% solution in each of Pipettes in one box.
ii. Number of Pipettes and sizes of Pipettes (with volume of solution in each
Pipette).
iii. Method of calculation of raw material for each of the boxes, containing 3 Pipettes
reflected in the application.
iv. Details of past production of Selameetin 6% SPOT ON Pipettes by the
supporting Manufacturers-M/s Disinfecto Chemical lndustries Pvt. Ltd, Lucknow
during last 3 years along with corresponding quantity of Selamectin API 99%
consumed.
3) The information at serial no. iv above may be got certified by an independent
Chartered Accountant.
4) This issues with the approval of competent authority.
Barnali Khastgir)
Phone:23323292
Email: barn. khast@ n ic. in
(Shri Nirmal Kumar, Dy DGFT),
Email: nirmal. ku ma 165@ n ic. in
9ヽ
´
④
F. No.350 11 11451201 6-Pl (Norms)
Government of lndia
ノ/ヒ
Dated: July, 2016
Office Memorandum
Case of M/s Orbit Life Sciences (P) Ltd.
The undersigned is directed to refer to DGFT U.O.No. 011821501308/AM-17/DES-
31218 dated the 617116 vide which application from M/s Orbit Life Sciences (P) Ltd. was
sent to this Department for fixation of norms under para: 4.7 for the export of lmipenem
(Sterite / Technical / N-Formimidoyl / Thienamycin 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:-
DGFT is advised to call following details/clarification from the firm viz:-
1) Whether the export item is sterile or technical grade.
2) lf sterile, please give details of conversion from tech. grade to sterile alongwith
yield etc.
3) The DML furnished by the firm is only for exporUmanufacture imipenem (Non-
Sterile). How the firm will be manufacturing/exporting Sterile product.
4) The import items at appendix-'l1A do not tally with ANF-4A.The correct and
revised list of import items may be furnished as many inputs have been shown
indigenous in appendix-1 1A
2.
(Raikumar)
Under Secretary to the Government oflndia
PH:-23071162
Ч
Ｉ
０
７
⌒
F. No.350 1 1 l22l 12016-PI (Norms)
Government of India
\0>2lL-
Shastri Bhawan, New Delhi,
Dated: September 12, 2017
Office Memorandum
## Subject: - Fixation of norms under para4.7 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. 011821501467lAM-lT|DES-3/436
dated the 1910812016 vide which application from M/s Optimus Drugs Pvt. Ltd. was sent to this
Department for fixation of nofins 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:-
l) The import item no.l 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-ir-vis actual consumption of all imported imported inputs duly
certified by Central Excise Authorities may be given.
4) Yo age of yield at each step of reaction on molar basis with chemical formula & M.W. of
each chemical involved in reaction.
(Parveen Kumar)
Under Secretary to the Government of India
E-mail: parveen. I 9@gov.in
Ph-23352298
(Shri S.K. Panigrahi),
E-mail : sk.panigrahi@nic. in
Ph: 23061562,8xtn.269
?5
F. No.350 1 1 12531201 6-PI (Norms)
Government of lndia
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 Morepen Laboratories Ltd.
The undersigned is directed to refer to DGFT U.O. No. 011821050/00451/AM-
17IDES-3/450 dated the 231812016 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 Saxagliptin Hcl. This department has examined the matter and the
following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2015-
20:-
2.) This issues with the approval of competent authority.
(Parveen Kumar)
Phone: 23352298
Email: parveen. 1 9@gov.in
Udyog Bhawan, New Delhi, Email: sk.paniqrahi@nic.in
1重
9`
S.No.
lmport item
Norms Recommended for
1ko Exoort
(AlphaS)-Alpha[[( 1,'l -
d imethylethoxy)carbomyllam inol-3-
hydroxytricyclo[3,3, 1, 1 3,7)]decane-1 -acetic acid
(sx00)
2.64kg
2
( 1 S, 35, 5s)-2-azabicyclo[3, 1, 0] hexane-3-
carbox-amide trifluoroacetate(SxsO 1 )
2.02kg
3
N-Hvdroxv benzotriazole hvd rate(HOBT)
1.1 8kg
4
N,N―diisopropvl ethvlamine(DIPEA)
2.30kq
5
Diisopropvl ether(IPE)
3.60kg
F. No.350 1 I 1225 12016-PI (Norms)
Government of India
Shastri Bhawan, New Delhi,
Dated: September 12, 2017
Office Memorandum
Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-20 Case of
M/s. Orbit Life Sciences Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O.No. 0ll82l50l385lAM-lT1DES-3/441
dated the 1910812016 vide which an application from M/s. Orbit Life Sciences Pvt. Ltd. was sent
to this Department for fixation of norms under para: 4.7 for the export of Cefuroxime Axetil
Amorphous. This department has examined the matter and the following comments are
furnished under para4.7 of Hand Book of Procedures (Vol.l) 2015-20:-
2.)
This issues with the approvalof competent authority.
(Parveen Kumar)
Under Secretary to the Government of India
E-mail : parv een.l9 @gov.in
Ph-23352298
(Shri S.K. Panigrahi),
S. No.
Imporl ltem
Qty. Recommended
kg/kg.
1
D-7 amino Cephalosporanic acid (D-7ACA)
0.79kg
2
Chlorosulphonyl Isocynate
0.53kg
り
Ｄ
Z)-2Methoxy Imino (furyl-2-Yl) Acetic Acid Ammonium Salt
SMIA)
0.835kg
4
Dimethyl Acetamide
l.12kg
5
Acetone
l.76kg
6
Methanol
0.62kg
7
Acetonitrile
0.9Skg
8
Activated carbon
0.1Okg
9
Acetone
1.76kg
qt
A\
F. No.3501 1 /34412016-Pl (Norms)
Government of lndia
Ministry of Chemicals & Fertilizers
@4
Shastri Bhawan,New Delhi,
Dated the April3,2017
Office Memorandum
## Subject: - Application from M/s J.B. Chemicals & Pharmaceuticals Ltd. for norms of
Amylmetacresol Antiseptic Throat Lozenges Sugar Free Blackcurrant
and Other Flavor and Amylmetacresol Antiseptic Throat Lozenges
Lemon/Cherry and Other Flavor.
The undersigned is directed to refer to DGFT U.O.No. 01/82/050/00582/AM-
17IDES-3/520 dated the 05i09/2016 vide which 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 Amylmetacresol Antiseptic Throat Lozenges Sugar Free Blackcurrant
and Other Flavor and Amylmetacresol Antiseptic Throat Lozenges Lemon/Cherry
and Other Flavor. Besides API the applicant also intends to import excipients for which
Master Batch Formula duly certified by the Quality Control ln-Charge of the company is
needed and the same is not provided with application.
2) ln view of the above, the applicant may be advised to provide copy of, Master BatcL
Formula duly certified_ty the Quality Control ln-Charge of the company so that the
iequirement of excipients may be worked out.
Barnali Khastgir)
Phone:23323292
Email: barn.khast@nic. in
(Shri Nirmal Kumar, Dy DGFT),
Email: nirmal. ku ma165@n ic. in
,8
―
― ― ~
t多g
F. No.350 I 1 16812017-Pl (Norms)
Government of lndia
Room No. 302, 3'd Floor,
Janpath Bhawan New Delhi,
Dated: November 15, 2017
Office Memorandum
Sub: - Fixation of norms under para 4.7- Application of M/s Aurobindo Pharma Ltd.,
Hyderabad.
The undersigned is directed to refer to DGFT U.O. No. 011821050/00846/AM-
17IDES-3 /833 dated the 0510112017 vide which an application from M/s. Aurobindo
Pharma Ltd. was sent to this Department for fixation of norms against export of
Amoxicillin 500 mg Tablets. (each containing Amoxicillin Trihydrate equivalent to
500 mg Amoxicillin. This department has examined the matter and the following norms
are furnished.
2.
((Parveen Kumar)
Phone:23352298
Email: parveen. 1 9@gov.in
(Shri Panigrahi, Dy DGFT),
Room No.414, Udyog Bhawan, New Delhi
Ｑ
、
Ｑ
Ｉ
Product to be Exported
Raw materials to be Imported
Description
Quantity
Ｓ
，
蘭
Description
Quantity
Amoxicillin 500 mg
tablets (each tablet
contains Amoxicillin
Trihydrate equivalent
to
500
mg
Amoxicillin)
1000
tabiets
6-APA
332.484 gm
2.
D(-) Para Hvdroxv Phenyl Glvcine
224.358 gm
3.
Methvl Aceto Acetate(MAA)
208.856 gm
4
Methanol(Methvl Alcohol)
171.042 gm
5.
Triethvlamine
16.975 gm
6.
Methylene Chloride
193.169 gm
7.
lso PropvlAlcohol
246.436 om
8
N― N―Dimethvl Acetamide
57.950 gm
9
Pivalovl Chloride
193.169 gm
'''--'-'-'t-
F. No.350 11 13612017-Pl (Norms)
Government of lndia
l4r
Room No. 302, 3'd Floor,
Dated: October 17,2017
Office Memorandum
Case of M/s Alembic Pharmaceuticals Ltd.
The undersigned is directed to refer to DGFT U.O.No. 011821050/00866/AM-
17IDES-3/793 dated the 2811212016 vide which application from M/s Alembic
Pharmaceuticals Ltd. was sent to this Department for fixation of norms under para: 4.7
for the export of Clarithromycin enteric coated granules 30% and 42o/o. This
department has examined the matter and the following norms are furnished under para
4.7 of Hand Book of Procedures (Vol.l) 2009-14: -
2.
(Parveen Kumar)
Phone: 23352298
Email: parveen. 1 9@gov.in
Email: sk.panigrahi@nic. in
Product to be Exported
Raw materials to be imported
Description
Qtv.
S. No.
Description
Quantity for 1000
kg
Clarithromycin enteric
coated granules 30%
1000 kg
Clarithromycin
273.00 kg
2.
Acetone
698.00 kg
Clarithromycin enteric
coated granules 42%
1000 kg
Clarithromycin
403.00 kg
2.
Acetone
1031.50 kg
|“
,.r
F. No.3501'l/367/2016-(Pl-Norms) ,/. r \ \
Government of lndia
( \t Y/
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. 011821050/00638 &
00629/AM-"17IDES-3/541 & 555 dated the 5/10/2016 &311012016 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 Docetaxel lnjection Concentrate 120m9/3m1,
80mg/2m1, 20mg/0.5m1. This department has examined the matter and the following
2.) This issues with the approval of competent authority.
(Parveen Kumar)
Phone: 23352298
Shri S.K. Panigrahi, Economic Officer, DES-Ill
Email: sk. paniqrahi@nic. in
|。
|
norms are furnished under para 4.7 of Hand Book of Procedures
oll)2015 |-20:―
S
No
Export Product
Ｓ
Ｍ
lmport product
Norms recommended
120m9
per 3ml
80mg
per 2ml
20mg per
0 5mi
1
Docetaxel injection
concentrate
120m9/3m1, B0mg/2m1,
20mg/0.5m1
1
Docetaxel
Trihydrate
13444
mg力nie
ction
89628m
9ノinjectio
n
23474m
g/iniectiO
n
2
Polysorbate 80
1040m
gノiniecti
On
1040m9/
inlection
1040mg/i
nieCtiOn
3
Rubber stopper
As per packinq policy
ヘ
F. No.3501 1/77 12017 -Pl (Norms)
Government of lndia
Ministry of Chemicals & Fertilizers
Shastri Bhawan, New Delhi,
Dated November 14,2017
Office Memorandum
## Subject: - Fixation of norms under para 4.7:Application of M/s Dr Reddy,s Labs Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82l050/00831/AM-
17lDES-lll/836 dated 05/01/2017 vide which application from M/s. Dr Reddy,s Labs
Ltd. was sent to this Department for fixation of norms against Export of sumatriptan
6mg/0.5m1 in 1 ml pre-filled syringes.
2) The application is for import of components of prefilled syringes. Moreover the
application is for import of required components 0119! tg-ttSt lggE-wtlhout ctaiming
any wastage. As such the DGFT may like to proiEE-The application as applieil.-
(Parveen Kumar)
Phone: Phone: 23352298
Email: parveen.l 9@gov. in
(Shri Nirmal Kumar Deputy DGFT),
Udyog Bhawan, New Delhii
Email: nirmal. ku ma165@ n ic. in
lo 1-
F. No.350 1 1 16812017-Pl (Norms)
Government of lndia
Roorn No.302,3rd Floor,
Dated: November 15, 2017
Office Memorandum
Sub: - Fixation of norms under para 4.7- Application of M/s Aurobindo Pharma Ltd.,
Hyderabad.
The undersigned is directed to refer to DGFT U.O. No. 01182150100863/AM-
171DES-3 /828 dated the O5lO1l2O17 vide which an application from M/s. Aurobindo
Pharma Ltd. was sent to this Department for fixation of norms against export of
Amoxicillin + Clavulanate Oral Suspension 400157 mg, in 50 ml, 75 ml and 100 ml
bottles. This department has examined the matter and the following norms are
furnished.
this issues with the approval of competent authority.
((Parveen Kumar)
Phone: 23352298
Email: Parveen. 1 9@gov.in
(Shri Panigrahi, Dy DGFT),
2.
Raw materials to be imPorted
Trihydrate equivalent to 400 mg
57 mg Clavulanic Acid )
for 1000 bottles (each 5
Amoxicillin + Potassium
ml contains Amoxicillin
Clavulanate equivalent to
Ｓ
．
わ
Description
Quantity recommended for 1000 bottles
50 rn!
75 rn!
100『nl
6-APA
2385.60 sm
3578.40 gm
4771.20 gm
2.
D(-) Para Hydroxy Phenyl Glycine
1968.70 gm
2953.05 gm
3937.08 gm
3.
Methyl Aceto Acetate (MAA)
1498.56 gm
2247.84 gm
2997.12 gm
4..
Methanol (Methyl Alcohol)
1227.24 sm
1840.86 sm
2454.48 gm
5.
Methvlene Chlo画de
1386.00 gm
2079.00 gm
2772.00 gm
6.
lso Propvl Alcohol
1768.20 gm
2652.30 gm
3536.40 om
7.
Pivalovl Chloride
1386.00 gm
2079.00 gm
2772.00 om
8
Clavulanate Potassium + Syloid/
Clavulanate Potassium diluted with
Silicon dioxide (1 :1)
1414.00 gm
2121.00 gm
2828.00 gm
lo3
/,
F. No.35011/21 12017-Pl (Norms)
Government of lndia
l{T
Dated: September 25, 2017
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-20
Case of ilt*sflo'ref€+#*d-
The undersigned is directed to refer to DGFT U.O.No. 01l82l51l957lAM-17/DES-
3/641 dated lhe 1511212016 vide which application from M/s. Morepen Labs Ltd. was
sent to this Department for fixation of norms under para'. 4.7 for the export of Sitagliptin
Phosphate (APls / Bulk Drugs). 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 ltem
Norms Recommended for
1kg Export
1
2,4,5 Trifluorophenylacetic Acid
1.167ks
2
Meldrum Acid
0.77ks
3
3-(Trifluoromethyl)-5,6,7,8-Tetrahydro-[1,2,4]
Triazolo [4,3-A] Pyrazine Hydrochloride
0.70k9
2)
(Parveen Kumar)
E-mail: parveen. 1 9@gov.in
Ph:-23352298
(Shri S.K. Panigrahi),
E-mail: sk.panigrahi@nic.in
Ph: 23061562, Extn.269
ヽ
―
F. No.350 11 18612017'Pl (Norms)
Government of lndia
Ministry of Chemrcal & Fertilizers
fi-5
Room no.310, B-wing, 3td floor,
Office Memorandum
## subject - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol'l) 2015-20
Case of M/s Mylan Laboratories Ltd'
The undersigned is directed to refer to DGFT U.O. Nq. 011821050/01168/AM-
17IDES-3/919 dated lhe 7t2t2017 vide which application from M/s Mytan Laboratories
Ltd. was sent to tnis oepartment 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.l) 2015-20'-
|
ffival
of competent authority.
(Parveen Kumar)
-
Phone:23352298
Email: Parveen. 1 9@oov.in
(Stiri S.K. Panigrahi, Economic Officer, DES-Ill
Phone No: 23061 562, (269)'
UOyogBhawan,NewDelhi,Email:sk'paniqrahi@nic'in
2.)
for 1kg ExPort
-3-( 1 -Ethyl-P ropoxy)-Cyclohex-
1 -Ene- 1 -CarboxYlate (EPoxide)
Cyclohexane
Tertiary ButYl MethYt Ether
0.671k9
Dichloromethane
loy
lmport item
S. No.
２
一
３
一
４
一
５
1.25k9
Sodium azide
1.00k9
1.578k9
Acetonitrile
1.088k9
3.6k9
６
一
７
Toluene
3.387k9
2.6k9
8
I
10
Hexanes
Acetone
1.445k9
n-Heptane
0.20k9
F. No.350 11 16812017-Pl (Norms)
Government of lndia
Room No. 302, 3'd Floor,
Dated: November 15, 2017
Office Memorandum
Sub: - Fixation of norms under para 4.7- Application of M/s Aurobindo Pharma Ltd.,
Hyderabad.
The undersigned is directed to refer to DGFT U.O. No. 011821050/01167/AM-
17IDES-3 /918 dated the O7lO2l2O17 vide which an application from M/s. Aurobindo
Pharma Ltd. was sent to this Department for fixation of norms against export of
Amoxicillin + Clavulanate Oral Suspension 600/42.9 mg, in 75 ml, 125 ml and 200
ml bottles. This department has examined the matter and the following norms are
furnished
2.
((Parveen Kumar)
Phone: 23352298
Email: Parveen. 1 9@gov.in
(Shri Panigrahi, Dy DGFT),
Room No. 414, Udyog Bhawan, New Delhi
辟
"
Raw materials to be imPorted
Trihydrate equivalent to 600 mg
42.9 mq Clavulanic Acid )
for 1000 bottles (each 5 ml contains Amoxicillin
Amoxicillin + Potassium Clavulanate equivalent to
Ｓ
，
脆
Description
Q“anfty recommended for f000わoffres
75 rn:
125 rnl
200 rn:
6-APA
5367.60 gm
8946.00 om
14313.6gm
2
D(-) Para Hydroxy Phenyl GlYcine
4429.20 gm
7382.02 gm
11811.24 om
3.
Methvl Aceto Acetate(MAA)
3371.76 gm
5619.60 gm
8991.36 om
4..
Methanol(Methyl Alcohol)
2761.28 gm
4602.14 gm
7363.44 gm
5.
Methylene ChloHde
3118.50 gm
5197150 gm
8316.00 gm
6.
lso Propvl Alcohol
3978.44 gm
6630.74 om
10609.20 gm
7.
Pivalovl Chloride
3118.50 gm
5197.50 gm
8316.00 gm
8.
Clavulanate Potassium + Syloid/
Clavulanate Potassium diluted with
Silicon dioxide (1:1)
1596.54 gm
2660.91 gm
4257.46 gm
|。(
F. No.350 1 I 1217 l2A1 7-(Pl-Norms)
Government of lndia
Room no.310, B-wing, 3td floor,
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-
20 case of M/s Divi's Laboratories Ltd.
The undersigned is directed to refer to DGFT U.O. No. 0118210501012231AM-
171DES-3 t1144 dated the 2313t2017 vide which application from M/s Divi's
Laboratories Ltd. was sent to this Department for fixation of norms under para: 4.7 for
the export of Free Amine Pivalate Ester. This department has examined the matter
and the following norms are furnished under para 4.7 of Hand Book of Procedures
2.)
(Parveen Kumar)
Phone:23352298
Email: parveen.l 9@qov.in
Shri S.K. Panigrahi, Economic Officer, DES-Ill
Udyog Bhawan, New Delhi-1 1001 1
、¢ λメト≒
Vol
2015-20:―
S. No.
lmport item
Norms recommended
for 1kg export
CBZ Aminonk面le
1.49kq
2
Hydroxyl amine free base - 50o/o
0.60kq
3
Petroleum ether 90 - 100 (Heptanes)
2.30kq
4
lso propvl alcohol
3 06kg
5
Methanol
6.928ks
6
Methvl tertiary butyl ether
3.08ks
7
N-methyl-2-pyrrolidinone
1.51ks
8
Glvcolic acid(70%wet)
0.533k9
9
Palladium metal
0.001lkg
10
Methvliodide
0.43kq
Hydrobromic acid
0.98kg
12
Fumaric acid
1.264kg
13
Caustic potash flakes
2.4kg
ls+
⑩
F. No.350 I I 14061201 6-Pl (Norms)
Government of lndia
Room No. 302, 3'd Floor,
Dated: October 9,2017
Office Memorandum
## Subject: - Fixation of norms against application of M/s J.B. Chemicals &
Pharmaceuticals Ltd for Amylmetacresol Based Lozenges.
The undersigned is directed to refer to DGFT U.O.No. 011821050/00731/AM-
17IDES-3/622 daled the 2311112016 vide which 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 Amylmetacresol Based 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.
(Parveen Kumar)
Phone: 23352298
Email: parveen. 1 9@sov.in
Product to be Exported
Raw materials to be imported
Ｓ
．
助
Description
Qレ
Ｓ
．
蘭
Description
Quantity
Amylymetacresol Antiseptic Throat
Lozenges Sugar Free blackcurrant and
other flavor. (each lozenges contains
Amylmetacresol 0.6 mg, Malic Acid 10.4 mg
& lsomalt ST-M 2533.567 mg
1000
Nos.
Amylmetacresol
0.612 gm
2.
Malic Acid Fine
Granular
10.400 gm
3.
lsomaL S丁―M
2507 gm
2.
Amylymetacresol Antiseptic Throat
Lozenges Lemon and other flavor. (each
lozenges contains Amylmetacresol 0.6 mg
and Malic Acid 20.8 mg
1000
Nos.
Amylmetacresol
0.612 gm
2.
Malic Acid Fine
Granular
20.800 gm
3.
Amylymetacresol Antiseptic Throat
Lozenges Cherry and other flavor. (each
lozenges contains Amylmetacresol 0.6 mg
and MalicAcid 10.4 mg
1000
Nos.
Amylmetacresol
0.612 gm
2
Malic Acid Fine
Granular
10.400 gm
108
F. No.3501 1 141412016-Pl (Norms)
Government of lndia
Shastri Bhawan, New Delhi,
Dated: September 8, 2017
Office Memorandum
Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14,
Application of M/s Gadila Healthcare Ltd.
The undersigned is directed to refer to DGFT U.O. No. 011821501719/AM-
171DES-3/623 dated the 23111t2016 vide which an application from M/s Cadita
Healthcare Ltd. was forwarded to this Department for fixation of norms for the export of
Mebeverine Hcl 200mg Tablets. This department has examined the matter and the
following norms are recommended against this application:-
(Parveen Kumar)
Under Secretary to the Govemment of India
E-mail: parveen. 1 9@gov.in
Ph-23352298
(Shri S.K. Panigrahi),
E -mail : sk.panigrahi@nic. in
Ph: 23061562,8xtn.269
９
″
S. No.
Import Product
Norms Recommended
1
Mebeverine Hcl BP
204meper tablet
lo1
\qq
F. No.3501 1 /69/201 7-(Pl-Norms)
Government of lndia
Ministry of Chemlcal & Fertilizers
Room no.310, B-wing,
Dated: October 12,2017
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. 01/82l050/00945/AM-
17IDES-3/834 dated the 51112017 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 Fibsol Tablet Smg, 10mg and 20mg (containing Lisinopril
Dihydrate equivalent to Smg, 10m9, 20mg Lisinopril respectively). 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)
Shri S.K. Panigrahi, Economic Officer,
Email: sk.paniqrahi@nic.in
(Parveen Kumar)
Phone: 23352298
DES-III
S
No
lmport ltem
No. of
Tablets
Norms Recommended
5mg
1Omg
20mg
Lisinopril Dihydrate
1000
5.5539ms
1 1 .1 Ogms
22.2139ms
||・
F. No.3501 1 /24412017 -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 RA Chem Pharma Ltd.
The undersigned is directed to refer to DGFT U.O. No. 01l82l05OlO1291lAM-
17IDES-3/1 181 dated the 291312017 vide which application from M/s RA Chem Pharma
Oxolamine Citrate. 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
'tkq Export
1
3-Chloropropionyl Chloride
0.556k9
2
Benzonitrile
0.453k9
2)
(Shri S.K. Panigrahi, Economic Officer,
Email: sk.paniqrahi@nic.in
(Parveen Kumar)
Phone: 23352298
DES-III
aoD
P>
F. No.35011 19012017-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 Mylan Laboratories Ltd.
The undersigned is directed to refer to DGFT U.O. No. 01l82tO5OtO1143tAM-
17IDES-3/892 dated the 71212017 vide which application from M/s Mylan Laboratories
Valganciclovir Hcl. 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 1kq Export
2-amino-1, 9-d ihyd ro-p u ri n-6-one
2.857k9
2
N-ca rbobenzyloxy-L-va I i ne
2.465k9
3
Bis(trimethylsi lyl) acetam ide
0.297k9
4
Hexamethyl Disilazane
2.237k9
5
2-acetoxymethoxy-1,3-diacetoxy propane
7.056k9
6
lmidazole
0.866k9
7
1, 3-dicyclohexyl carbod imide
3.064k9
8
N, N-dimethyl formamide (DMF)
19.46k9
9
Activated carbon
0.1 Okg
2.) This issues with the approval of competent authority.
(Parveen Kumar)
Phone: 23352298
Udyog Bhawan, New Delhi, Email: sk.paniqrahi@nic.in
llL
一
F.No.35011′ 196′2017‐{P卜Norms)
Government oflndia
Ministry of Chemicals&Fertilizers
Department of Pharrnaceuticals
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-20
case of M/s Mylan Laboratories Ltd.
The undersigned is directed to refer to DGFT U.O. No. 011821050/01307/AM-
17IDES-3/1136 dated the 211312017 vide which application from M/s Mylan Laboratories
Dipyridamole. 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
．
Ｎ
。
lmport item
Norms recommended
for 1kq exoort
1
2,6-Dichloro-4,8-Dipipettdino― Pyttmido¨ (4,5-d)
Pvttmidine
0.935kg
2
Diethanolamine
0.669kq
3
Toluene
3.2kg
2.) This issues with the approval of competent authority.
(Parveen Kumar)
Phone: 23352298
Shri S.K. Panigrahi, Economic Officer, DES-Ill
Phone No: 2306'1562, (269),
Email: sk.paniqrahi@nic. in
身1好
||ら
F. No.3501 1167612012-Pl (Norms)
Government of India
/パ
Udyog Bhawan,
New Dclhi,thc 12血March,2013
Offlcc Memorandum
SubiCCt:― F破ation ofpttdCr para 4.7 of Hand B00k Of Procedures(V01・1)2009-14 Casc ofゝ〃S.
stttd.
ASJ
2009-14:―
f,R.co*..nded kg/kg.
Import Item
e hYdrate (E-2)
ycl,o PropYl AcetYlene
c Acid MOno hydratc
etra hydrofuran
ine-totution (30%-40%
面冨こ拍』ぜ師面可て西
「
『00%)(NPN)
ti Fluoro Ethanol(TCE)
2.
This issues with the approval of Director (Cost)'
Directorate General of Foreign Trade'
d;. ;il
Maini, FTDo), Udvog Bhawan' New Delhi'
(N.N.Ahuia)
section Offlcer
Pl―Norms
llЧ
ノ
Office Memorandum
Sub: - Fixation of norms under para +Tpptication-f M/s Cadila Healthcare Ltd'
The undersigned is directed to refer to DGFT U.o. No. o1t82l5oto0939/AM-17/DES-3
ig05 dated rhe 2gt12t2016 vide wnicn an apprication from Mis. cadira Hearthcare Ltd. was sent
to this Department for fixation of normi against export of pravastatin sodium 10m9, 20m9,
40mg and gOmg Tablets. This departmeit has examined the matter and the following norms
are furnished oaseJ upon the DML and composition details provided with the application'
F.No.35011/40′2017-PI(Norrns)
Government oflndia
Department of P harmaceuticals
Room No. 302, 3'd Floor,
JanPath Bhawan New Delhi,
Dated: November 8,2017
/ =required and X=nOt required
2. The inputs frorn s.no.4 to 1 3 are packing rnaterials and rnay be perrnitted as per DGFT's
Packin3'POiicy,「品
he:とき
ver required as perthe above table.
3Thisissueswiththeapprovalofcompetentauthority.
((Parveen Kumar)
Phone: 23352298
Email. Parveen' 1 9@gov'in
(Shri Panigrahi, DY DGFT)'
Roo, No.414, UdYog Bhawan, New Delhi
ffi
Exportof lNo.Tablet
Ｓ
．
Ｎ
。
lmport item
10mg
20mg
40mg
呻
一
Pravastatin sodium
10.20 mg
ZU.4U mg
■υ.OVl‖u
Ul・VV lllv
258.00 mg
■na a■_A
2
M icrocrystalline Cell ulose
32.25 rng
64.50 rng
lZυ .UU【119
3
Lactose AnhYdrous
31.24 rng
102.4じrng
∠U4.U′
I‖ 9
lv
V
4
DPE Botue
/
′
/
X
X
X
5
lon cc wh計O HDPE Botue
Ｘ
一
Ｘ
一
Ｘ
一
／
／
一
Ｘ
一
Ｘ
一
／
X
/
6.
150 CC VVhle HDPE Bottle
/
X
7.
~400 CC Whne HDPE Bottle
X
/
8.
750 CC Ⅵ′hle HDPE Botue
/
X
9.
aq trlu-an0 Cans Liner
X
X
X
/
10.
38 MM-400 CaPs Liner
/
/
X
X
CAP 38 MM PP With PULP
Liner
X
X
/
/
12.
NCRC WH CAP 53 MM PULP
Liner
13.
Packing insert Pravastatin
Sodium Tablet
/
/
/
/
サ
l√
/
多
F. No.350 1 1 134612017 -Pl (Norms)
Government of lndia
Room no.310, B-wing, 3td floor,
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 Healthcare Ltd.
The undersigned is directed to refer to DGFT U.O. No. 011821050/00503/AM-
18/DES-31267 dated the 4t10t2017 vide which application from M/s Cadila Healthcare
Ltd. was sent to this Department for fixation of norms under paru 4.7 for the export of
Hydroxy Chloroquine Sulfate. This department has examined the matter and the
foilowing norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l)
2015-20:-
2.) This issues with the approval of competent authority.
(Parveen Kumar)
Phone: 23352298
Email: parveen. 1 9@gov.in
Udyog Bhawan, New Delhi, Email: sk.paniqrahi@nic'in
′
０
・
０
Ｓ
Ｎ
lmport item
Norms Recommended for
1kq export
4.7 Dichloroquinoline
0.70ks
2
Hvdroxv Novaldiamine
0.65kg
F.No.35011/180ノ2017-PI(Norms)
Government oflndia
Ministry Of Chemical&Fertilizers
Department of Pharrnaceuticals
Room No. 302, 3'd Floor,
Dated: November 23, 2017
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s
BioTech Opthalmics (P) Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01l82l05OlO12O3lAM-17iDES-3t1106
dated the20l03l2o17 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 Optivisc (2ml PFS) (Sodium
Hyaluronate lnjection) This department has examined the matter and the following norms are
furnished: -
Product to be Exported
Raw materials to be imported
Description
Qry
S.No.
Description
Quantity for f000
viars Of2′
"′
eacカ
Optivisc (2ml PFS)
Sodium Hyaluronate
lnjection (each ml contains
Sodium Hyaluronate 10
mg)-2 ml vials
f000
via′s of2
m′ eacカ
Sodium Hyaluronate
22 gm
2.
Barrels
1000 Nos.
3.
Plunger Rod
1000 Nos.
4.
Plunger Stopper
1000 Nos.
5
Back Stop
1000 Nos.
6.
Blister
1000 Nos.
7.
Tyyvek Lid(PaCking
Matettal)
1000 Nos.
2.
(Parveen Kumar)
Phone:23352298
Email: sk. paniqrahi@nic.in
||■
ヘ
F. No.3501 1 I 18212017-Pl (Norms)
Government of lndia
//
Room No. 302, 3'd Floor,
Dated: November 23, 2017
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14 Case of M/s
BioTech Opthalmics (P) Ltd.
The undersigned is directed to refer to DGFT U.O.No. 011821050/01188/AM-17/DES-311103
dated the 20103/2017 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 Visc Ortho (2 ml PFS)
(Sodium Hyaluronate Injection). This department has examined the matter and the following norms
are furnished: -
Product to be Exported
Raw materials to be imported
Description
Q″
●
０
Ｓ
Ｎ
Description
Quantity for f000
viars Of2 m′ eacカ
Bio Visc Ortho (2 ml PFS)
Sodium Hyaluronate
lnjection (each ml contains
Sodium Hyaluronate 10
mg)-2 ml vials
f000 viars of
2′
"′
eacカ
Sodium Hyaluronate
22 gm
2.
Barrels
1000 Nos.
3.
Plunger Rod
1000 Nos.
4.
Plunger Stopper
1000 Nos.
5.
Back Stop
1000 Nos.
6.
Blister
1000 Nos.
7.
Tyyvek Lid(PaCking
Matettal)
1000 Nos.
2.
(Parveen Kumar)
Phone: 23352298
Email: sk.paniqrahi@nic.in
ハ3
a>fl,N"1%
,;
/
F. No.3501 1t18112017-Pl (Norms)
'.-'
Government of lndia
---'-
Room No. 302, 3rd Floor,
Dated: November 24, 2017
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s
BioTech Opthalmics (P) Ltd.
The undersigned is directed to refer to DGFT U.O.No. 0118210501012041AM-17/DES-311107
dated the 20103/2017 videwhich 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 PIus 1 ml PFS (Sodium
Hyaluronate Ophthalmic Solution) This department has examined the matter and the following
norms are furnished: -
Product to be Exported
Raw materials to be imported
Description
Qry
●
０
Ｓ
Ｎ
Description
Quantity for f000
viars Of f mr eacrP
Bio Hyalur Plus 1
ml PFS (Sodium
Hyaluronate
Ophthalmic
Solution) (each ml
contains Sodium
Hyaluronate 14 mg
in 1 mlvials)
f000
viars Of f
m′ eacカ
Sodium Hyaluronate
15.4gm
2.
Barrels(Hypak sCF 2.25 nnl RF
PRTC FM 27)
1000 Nos.
3.
Plunger Rod(Hypak PR 2.25 rnl PP)
1000 Nos.
4
Plunger Stopper(Hypak BSCF l… 3
mlPH mlPH 701/50C BLK S11000
WWD)
1000 Nos.
5.
Back Stop(BaCk Stop l-3mlPP
Clear)
1000 Nos.
6.
Blister (PP Blister 2.25 ml/3.0 ml)
1000 Nos.
7.
Cannula (Component for Prefilled
Syringe)
1000 Nos.
8.
Tyyvek Lid (Packing Material)
(Packing material for Prefilled
Syringe)
1000 Nos.
2.
(Parveen Kumar)
Phone: 23352298
Email: parveen.l 9@qov.in
Email: sk.paniorahi@nic.in
０
１
…
Fo No.35011′ 269′2017‐(P卜NorFnS)
Government ofindia
Ministry of Chemical&Fertilizers
Department of Pharrnaceuticals
Room no.310, B-wing, 3td floor,
Office Memorandum
## Subject: - Fixation of norms under para4.7 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. 011821050/01389/DES-
3t27 dated the 12t412017 vide which application from M/s Alembic Pharmaceuticals
Duloxetine 30mg & 60mg Capsules. This department has examined the matter and
the following norms are fuinished under para 4.7 of Hand Book of Procedures (Vol.l)
2015-20:-
S.No.
lmport item
Norms Recommended for 1000
Capsules
30m9
60mg
Duloxetine Hydrochloride PH Eur
34.30gms
68.60gms
(Parveen Kumar)
Phone: 23352298
Email: parveen. 1 9@qov'in
ユgF
2.)
Shri S.K. Panigrahi, Economic Officer'
Udyog Bhawan, New Delhi-1 1001 1
Email: sk. paniqrahi@nic. in
DES― |‖
|"
F. No.3501 1/86412015-Pl (Norms)
Government of lndia
Shastri Bhawan, New Delhi,
Dated: April 10,2017
Office Memorandum
Sub: - Fixation of norms under para 4.7- Application of M/s Mangalam Drugs & Organics Ltd.' Vapi
for export of Artemether-an anti-malarial drug'
The undersigned is directed to refer to DGFT U.O. No. 01l82l5OlO1646lAM16/DES-3/1762 dated
02.03.2016 and subsequent letter from M/s Mangalam Drugs & Organics Ltd, for fixation of norms
against export of Artemether-an anti-malarial drug. lt may be recalled that following norms were
earlier recommended against some of these applications.
S.No/ 7
lmport ltem
Norms applied kg/kg
Norms Recommended for I kg
Artemether
ノ
Artemisinin
1.35
1235
2
Sodium Borohydride
0.22
0188
J
Trimethvl Ortho Acetate
1.75
0.50
ucedquantityofTrimethylorthoAcetate(TMoA)and
have requested to increase it to 1.75 kg/kg as against 0.50 kg allowed against 1 kg of Artemether.
3) Technical examination: (i) The manufacture of Artemether (M.W 298) from Artemisinin (M.W
282) is essentially a two stage process. ln the first stage Artemisinin is reduced to get Dihydro
Artemisinin (M.W 284).90.3% yield is claimed by the applicant in this stage. During second stage
TMOA is used to convert Dihydro Artemisinin into Artemether crude with 84.4 % reported yield. The
crude end product is subjected to purification and 91 .4 % yield is reported by the applicant.
considering the percentage yields obtained at each stage by the company only 0.52 kg TMOA is
the calculated requirement for I kg Artemether. Furthermore, in all other applications from other
companies not more than 0.50 kg TMOA has been allowed.
4) The norms allowed for the export product were also based upon roughly same levels of yields
obtained in manufacture of Artemisnin. The DoP has considered 90% optimum yield in first stage'
85% yield in second stage and 95% yield in the purification stage'
5) ln view of the above, there is no justification for upward revision of TMOA consumption norms
allowed against this aPPlication
6) This issues with the approval of competent authority
(Barnali Khastgir)
Phone: 23323292/Email: barn.khast@nic.in
(Shri Nirmal Kumar, DY DGFT)'
Email: nirmal.kuma165@nic. in
121
F. No.350 1 1 134412A17 -Pl (Norms)
Government of lndia
Department of Pha rmaceuticals
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-
20 Case of M/s Glenmark Pharmaceuticals Ltd.
The undersigned is directed to refer to DGFT U.O. No. 01/82/050/00616/AM-
18/DES-3/362 dated the 17111t2017 vide which application from M/s Glenmark
Pharmaceuticals Ltd. was sent to this Department for fixation of norms under para: 4.7
for the export of Atovaquone. 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
1kq export
Trans-4-(4-chlorophenyl) cyclohexane
2.Okg
2
2-chloro- 1,4-Napthoquinone
1.62kg
2.)
(Shri S.K. Panigrahi, Economic Officer'
Email: sk. paniqrahi@nic. in
(Parveen Kumar)
Phone:23352298
DES-III
}2レ
F.No.35011/173/2016-PI― Norrns
哩星潔鯨爾‖当脇ξ /r
Shastri Bhawan,
New Delhl,the September 26,2016
o「ice Memorandum
SubieCti l∫
l:』[IL里111』曽:」111「1lf堆呈:17ofHandB00kOfProcedures(VOI.|)2009-14 Case
3244膜『席晶那::1ぎ隠¶‖
:f鶏IL
織珊‖誇魚路
]義報鸞
2009… 14:―
(Raj Kumar)
Phone: -23071162
Email: usPi3-Pharma@nic'in
Directorate Genera1 0f Foreign Trade,
W∬騨朧il刊剛
翠孵濁a淵
"
2) This issues with the approval of competent authority'
12Ъ
Norms Rttcommended
importitem
S.No
500 rrb/
250rng V
5グ./
282.75
F. No.350'1 1/10212016-Pl (Norms)
Government of lndia
9v
Dated: August,2016
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-
'14 Case of M/s Strides Shasun Ltd.
The undersigned is directed to refer to DGFT U.O.No. 0118215011311A.M-
17IDES-3/96 dated the 2315116 vide which application from M/s Strides Shasun Ltd.
was sent to this Department for fixation of norms under para: 4.7 for the export of
Nystatin Tablets 500000 units (86.99m9). 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
S.No.
lmport item
Norms Recommended
1
Nystatin USP
88.73msitablets
,ル｀
1
/
37ケ
F No.35011/864′2015-PI(Norms)
Government oflndia
Ministry of Chemical&Fertllizers
Department of Pharrnaceuticals
ShaStri Bhawan,New Delhi,
Dated:Ap門110,2017
sub― FI響
ま圧11蹄
『
:Iぽ11ゑP鴨」創
1°
ndMたMangttam Drugs&OЮ a面cs蜃と,Vapi
al drug.
The undersigned iS directed to refer tO DGFT U.0.No.01ノ82/50/01646/AM16ノDES‐ 3ノ1762 dated
02.03.2016 and subSequentletter from M/s Mangalam Drugs&OrganiCS Ltd,fOr fixatiOn of norrnS
::il::|』::品1:l:::DI晏∫ll:|::lf!r:}‖:里
r:1』
麗1:Isilaybereca‖
ed that fO‖ owing n° rrns Were
lmport ltem
|=■キ_上型半讐翌ギfヨ豊
=丘
壼量廿漱万百五茸裏:TrハH:1企ハ西扇]二扇titv Of Tttmethvl Ortho Acetate(TMOA)and
2)The applicant haS represented against reducel
have requested to increase itt0 1.75 kg/kg aS against O.50 kg a‖
owed against l kg of Artemether.
淵
側磁藻 i
TMOA is used tO COnVert Dihydro Arternisinin into
crude end prOduct is Subiected tO puriflcation and 91.4 % yield is reported by the applicant.
Conddenng he peκ emageゾddsoЫJneddeTlぶ
話
∴IT邸:∬露雌lttξ:ryttζ
the calCulated requirement fOr l kg Artemether.
companies nOt more than O.50 kg ttMOA has been a‖ oWed.
:な肌:1∬鼻闇脚Tぶぶ
i『常H:Ю
J"h∞du"nЮ鴫‖
y mmettdS dゾd“
has considered 90%Optimurn yield in first stage,
85°/O yield in Second Stage and 950/o yield in the purifiCation stage. _
5)ln vieW Ofthe above,there is nO lusllCauOn fOr upward revision of TMOA consumpJon nOrm,
a‖owed againSt thiS application
6)ThiS iSSues with the approval of competent authority
Y胤蹴肌塀晶♀W鳳躙
i
Directorate Genera1 0f Foreign Trade,
爾∫
』蠣鮒酔
n,
Emall:nirmJ.kumar650nic.in
ttornrs Recommended for 1kg
ttormsapPlied kg/kg
ps
F.No.350l 1t421t2016-PI (Norms ) 7 QY
Government of India
Department of Pharmaceutical s
Shastri Bhawan,New Delhi,
Dated:September ll,2017
Offlce Memorandum
StteCt―」鰭:TWi冨器∬鏃
I:理瞥こ正属
ind B°°
k Of Procedurcs Cd・り
2015…20.
Thc undersigned is dircctcd to rcfcr to DGFT U.0.No.01/82/50/755/AM-17/DES―
3/636 datcd the 30/11/2016 vide which application frorn
Ⅳ1/S Supriya Lifc Scienccs Ltd.was
"mゎ
面sD"江mcmおr ix狙on」nomsI蹴
籠Ъ l篤
轟
認
壕魚
棚
猛諄
肌Iザ群鵬Ⅷ驚if瀾露:お∬市
;1,2Q―
2.)
This issues with the approval of competent authority'
(ParVecn Kumar)
Undcr Sccretary tO thC Govcrrment oflndia
E―mail:parveen.19@gov・in
Ph:23352298
Directoratc Gcncral of Forcign Trade,
Department of COmmcrce,
出::視賠機Ddh
E―mail:sk.panlgrahi@niC・in
Ph:23061562,Extn.269
Import item
ne Hcl
0.015k
Palladium on Charcoal 5ol,
)2/`
F. No.350 1 1 13491201 7-(Pl-Norms)
Government of lndia
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.
The undersigned is directed to refer to DGFT U.O. No. 01182105010049214M-
18/DES-3/331 dated the 11t10t2017 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 4. This department has examined the matter and
the following norms are fuinished 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
1
Ervthromvcin Base USP
1.S8kg
2
Hvd roxvlam ine hyd rochloride
0.714kg
3
Methanol
2.24kg
4
Methane Sulfonyl Chloride
0.47k9
5
Acetone
6.45k9
6
Ethvl Alcohol
2.81 Ltr.
7
Platinum Metal
0.05gm
tL7
F No 35011/102/2016-Pi(Norms)
Government oflndia
Ⅵ
:騒7諾[Rlili:1麻」
::11:昴ξ
Udyog Bhawan, New Delhi'
Dated: August,20"16
Office Memorandum
Subiect:-Fixationofnormsunderpara4.TofHandBookofProcedures(Vol.l)2009.
'
14 Case of M/s Strides Shasun Ltd'
The undersigned is directed to refer to DGFT U O No' 01/82/5.0/131/AM-
17IDES-3/96 dated the 23l5/i6;il; which application from M/s Strides Shasun Ltd'
was sent to this Department for fixation of norms under para: 4 7 for the.,export of
i.ivItII" iiui"i"iobooo ,nit 1ae.ss.g). rhis department has examined the matter
and the following norrn. ","'i"nished
riider para 47 of Hand Book of Procedures
(Vol.l) 2009-14:-
2
This issues with the approval of competent authority'
(Ralkumar)
Under Secretary to the Gove:Ire,:8;IT:3
Directorate Genera1 0f Foreign Trade,
障∬節朧il
′理
F. No.3501 1t15st2016-Pl (Norms) 1q
Government of lndia
Dated: SePtember,2016
Office Memorandum
## subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol'l) 2009-
14 Case of M/s Strides Shasun Ltd'
The undersigned is directed to refer to DGFT U.O.No. 011821501185/AM-
171DES-3/183 datei the 4t7t16 vide which application from M/s Strides Shasun Ltd'
was sent to this Department for fixation of norms under para: 4'7 for the export of
Metoprolol Tartrate Tablets USP 25mg. This department has examined the matter
and the following norms are furnished under para 4.7 of Hand Book of Procedures
(Vol.l) 2009'14'.-
2.
This issues with the approval of competent authority'
(Rajkumar)
PH.23071162
Croscarmellose sodium
Relevant, as Per Packing
Closure 38mm CRC
121
F. No.3501 1/52 12017 -Pl (Norms)
Government of lndia
+2r--
JanPath Bhawan' New Delhi,
Dated: SePtember 25' 2017
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. O1/82/50/906/AM-17/DES-3/664
dated the 21112t2016 videwhich application from M/s Sun Pharmaceuticals lndustries Ltd was
sent to this Department for fixation of norms under para: 4.7 for the export of Tobramycin
300mg/5ml Nebuliser solution. 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)
E-mail: Parveen. 1 9@gov in
Phi23352298
(Shri S.K. Panigrahi)'
E-mail: sk.Panigrahi@nic.in
Ph: 23061562, Extn.269
Mrms Recommended
for 100 amPoules
lmport item
Export item
Tobramycin PH. EUR.
Tobramycin 300m9/5ml
Nebuliser Solution
l3o
B-"a
F. No.350 11t343t2017-Pt (Norms) P -: f
Government of lndia
b-
Office Memorandum
## Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-
20 Case of M/s DSM Sinochem Pharmaceuticals Ltd.
The undersigned is directed to refer to DGFT F.No.01/8215015281AM07/DES-
3/90 dated the 20/1 112017 vide which representation from M/s DSM Sinochem
Pharmaceuticals Ltd. was sent to this Department for amendment in norms for the
export of Amoxycillin Trihydrate Pen G Route Through Enzamatic Route. The
representation of the firm has been examined and taking quantity from SION-A-S8 &
as per our past recommendation following quantity are recommended for 1kg of
Amoxycillin Trihydrate Pen G Route Through Enzamatic Route
2)
(Shri S.K. Panigrahi, Economic Officer,
Email: sk. paniqrahi@nic. in
(Parveen Kumar)
Phone: 23352298
Email: parveen. 1 9@qov. in
DES-III
S. No.
lmport item
Norms Recommended
Penicillin G Potassium lstcrystal
1.664BOU/kg
2
D(-) para hydroxyl phenyl glycine methyl ester
0.608k9
3
Oxilasa enzyme
5.09m
4
Penicillin G amidase enzyme
0.8529m
5
Methanol
0.0215ks
6
Butyl acetate
0.122k9
7
Boric acid
0.032k9
131
―
―
―
―
―
―
―
―
‐
‐
も
―
品
鳳
´
午
## Case No 35/12/82´
ハlC4′2oll
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01/82/050ノ00368/Alt4 1 2/
Party Nal¬ elTIDE
llNIDi,sttR!ES
RLA File
i34/24/040/Oo301/AMllノ
lv4eet NO/Date 12/82‐
ALC`/2oll
21062011
Lic No/Dat●3410030201
1205201]
Status Ca
Apprcvec
:::算『1:nF:T811長::,lFl埠r「lFァFITィ嘱ヌ早異111〃11 19Ⅲ d面■01 Commms bmardedl
76 Depa腱ment d c&Pc輛de hL「1」16:ヽ:° 1漏13混サ
う
;尾13#|1電:[α
n/rlien commen“ bmarded l
vtrith iechnicai nlirh∩
r)lt′
n「Ocon,:^_^_`:__ i ・, , 1 , ヨted 21 06 201l and in cOns占itati(
出i配晰七
,■::冒i∬Tl智1服rlrll呈,電:d=~Z品罵胤篤腿fttT;肝聯電ξ
[
dda″ s bdOw Oras ap白港d gFI語佛‖蔦Lttri」∬
_
RA cOncernёd may take rurther nOcessary pct10n as perabove decisiOn of NC_
○
{・
バ
”
I
I
F. No.350 1 1 t7 61 t2O1 S-pt (Norms)
Governmerit of lrrdia
Departmerrt of Pliarrnaceuticals
6-||
I Room no.310,B_wing,3rd l。。r,
| 」anpath Bhewan,New Delhil
l Dated:December 7 ,2017
0ffice Membrandum
Suぽ
曰xmm dn∝ms undtt para 47 dland B00k d PЮ cedwes Ⅳdめ2略20
Case of Mノs Ferrnenta BiOtOch Ltd.
The undersigned is directed tO referi10 F.No, 01/82/50/1078/Aル
!-16ノ[DES-3/81
き棉t糧∴棚
17常鮒
‖FTttt棚
詳
素
弼
蔦∫l職
i榔
Oral Solution uSP(vitamin D2 1.O to 4.(
matter and DGFT is requested to callfOIlowiぃo infOrmation from the irmi
t釧
認
Ⅳ轟liSI,°
・
produd ttibms d lM旧:2A/11U,3ⅢU&4MIU od
| 』グ鷺″′フ
| (ParVeen Kumar)
Under Secretary to the Government oflndia
l E―
mail:parveen.19@9ov.in
I Ph:23352298
Directorate General of Foreign Tracle,
Depa rtrnent of Conrmerce,
(Shri S.K. Panigralri),
E-mail. sk.panigralri@nic. in
Ph: 23061562, Extn.269
135 1
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