DGFT Committee Minutes
Document text
1 Office of Directorate General of Foreign Trade New Delhi -0
Para 4.7 Decision
Meeting No. 03/8212018 of 2018-19 dated 05.06.2018 (actually held on 27.06.2018,28.06.2018 and 05.07.2018) considered the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy,2015-20 pertaining to Chemical and Allied products falling under Chapter 29 and 30, held under the Chairmanship of Shri J.V. Patil, Addl. DGFT in Room No.l l, Udyog Bhawan, New Delhi. Following members were present:- Shri Nirmal Kumar, Dy. Director General of Foreign Trade Shri S.K. Panigrahi, Economic Officer Consultant, Techn ical Expert Pharmaceuticals Consultant, Technical Expert Chemicals The committee went through the minutes of earlier meeting No.02/8212018 of 2018-19 dated 16.05.2018 (actually held on 06.06.2018, 13.06.2018 and 14.06.2018) and approved the same. ⅣIEETINC NUMBER :3/82¨ ALC4/2018 MEETING DATE:05.06.2018
Case No.:60/17/82¨ ALC4/2016 1Party Name:MYLAN Meet No/Date:3/82- Status: ‐
‐ iLABORATORIES LIMITED IALC4/2018 1Approved l 05.06.2018 ‐ IHQ File:01/82/050/01021/AM17/IRLA File lLic No/Date:0910055945 1 1 109/24/040/00021/AM14/ .0705.2013 1 : IDecisbn:Comm撤ee conddered case as per agenda and ddberated on the matter h the pК sence ofthe techmcJ I experts and it was decided to rati″ the ad_hoc input output norms under para 4.7 of HBP as per details below or as applied by flrm whichever is lo、ver: Export Product Qty. Sl.No. Import items Quantity allowed in ke EFAVIRENZ(NI Route) l kg 1 4‐Chloloaniline 1.10 2 D―f+)―Camohoric Acid 2.85 2.2.2 -Ethy tr iflu o ro ac etate 0.642 4 Citric Acid 0.81 Cyclopropylacetylene 0.524 6 Dichloromethane 7.20 7 Dimethylformamide 2.99 Ethyl bromide 0.545 9 Methanol 0.50 10 Methyl Tert-butyl ether 0.66 n-Heptane 1.56 つ ‘ Tetrahydrofuran 5.16 Tetramethy lethyelenediamine 0.80 14 Triethvlamine 1.70 Triphosgene 0.498 RA concerned may take further necessary action as per above decision ofNC
Case No.:5/17/82-ALC4/2016
,Party Name:SNF tlNDlAl PVi. IMect No/Date:3/82- IALC4/2018 105.062018 LTD., IHQ File:01/82/050/00966/AM17/IRLA File Lic.No/Date:2610012456 :26/24/040/00012/AM14/ 127.02.2014 || ２ ‥ ｔ ・ 一 Decision : Committee considered case as per agenda and deliberated on the matter in the presence of the technical r
2 experts and it was decided to ratit/ the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower with the condition that the firm will produced testing report or any other .documentsevidenceindicatingNonVolatileSolids40+/-2ohinexportproducttotheRA. Export Product Qty. SI.No. Import items Quantity allowed in kg FL 45C[FL 4540] [Non Volatile Solids 40+/― 2%] 51000.000 kg 1 FLOCRYL DADMAC 21420.00 kg RA concerned may take further necessary action as per above decision ofNC : ICase No.:148/6/82¨ALC4/2017 F鵠既 :::::ljl↓ij IParりName:VENUS REMEDIES ILTD., IRLA File 122/24/040/00016/AM15/ IMcet No/1Date:3/82- IALC4/2018 105.06.2018 1Lic.No/1Date:2210014909 123.05.2014 Status: Deffered and Re-indexed Defer Date:05.06.2018 I Decision I Deferred for comments of TE ICase No.:38/8/82-ALC4/2014 1 ,ParりName:MYLAN :LABORATORIES LIMITED IMeet No/Date:3/82- ALC4/2018 105.06.2018 Status: Approved HQ File:01/82/050/00702/AM15/RLA File :09/24/040/00108/AM15/ Lic.No/Date:0910060258 28.05.2014 Decision : Committee considered case as per agenda and deliberated on the matter in the presence of the technical iexperts and it was decided to ratifu the ad-hoc input output norms under para 4.7 of HBP as per details below or as rapplied by firm whichever is lower: Export Product Qty. Sl.No. Import items Quantity allowed in ke DARUNAVIR ETHANOLATE l kg 1 (S,S)-BOC Epoxide (or) tert- butyl-( I S)- I -[(2S)-oxiran-2- yll-2-phenylethylcarbamate (or) (2S,3 S)- 1,2-Epoxy-3 -(Boc- amino)-4-phenylbutane (or) (2s,3s)- 1,2-epoxy-3- (butoxycarbonyl)amino-4- phenyl butane [(S,S)-BOC Epoxidel 112 2 Isobutylamine 1.648 P-N itrobenzene sul fonyl chloride 104 4 (3R,3aS,6aRD― hexahydromr。[2,3¨b]hran_3- y14-nitrophenyl carbonate (or)Nitrocomplex(DAR― HA) 0656 Activated CarbonfENO― PC) 0.100 6 Methanol 5.37 7 Triethylamine 0.40 NMPO (or) N-Methyl pyrrolidone 4.16 9 Methylene Dichloride 682 10 Isopropyl alcohol 4.94 :RA concemed may take further necessary action as per above decision ofNC | | 14
aJ lCase No.:214/13/82-ALC4l20l4 tParfy Name:BLISS GVS rMeet No/Date:3182- lStatus: PHARMA LTD. ALC4l20l8 tApproved 05.06.2018 15 1 : IHQ File:01/82/050/01217/AM15/RLA File Lic.No/Date:0310787982 1 1 1:03/94/040/00386/AM15/ 112.08.2014 1 1Decision:Committcc considered case as per agenda and deliberated on the matter in the presence ofthe technical leXperts and it was decided to ratitt the ad― hOC input output norms under para 4.7 of HBP as per details below or as applied by flrm whichever is lower: Ｓ ‐ ． Ｎ 。 Export Product Qty. Import items Quantity allowed in gm/gm content in export product as per DML 1 BLISS FAST PESSARY Net Content oflmportltem Used― Nystatin BP-9.162 Kgs Number NYSTATIN BP 1.02 つ ４ GYNANFORT PESSARY Net content oflmport ltem used‐ Nystatin BP-9.162 Kgs Number NYSTATIN BP 1.02 GVGYL‐N PESSARY Net content oflmportltem uscd― Nystatin BP-9 162 Kgs Number NYSTATIN BP 1.02 4 WELLGYNAX PESSARY Net content oflmport ltem used― Nystatin BP¨ 9.162 Kgs Number NYSTATIN BP つ ４ ハ υ GYNASTATIN PESSARY Nct content oflmport item used‐ Nystatin BP-9.163 Kgs Number NYSTATIN BP 1.02 RA concerned may take further necessary action as per above decision of NC 1 ICase No.:111/13/82‐ ALC4/2014 IPaty Name:ABEERS 'PHARMACEUTICALS PVT ILTD IMeet No/Date:3/82‐ IStatus: IALC4/2018 1Approved l IALC4/2018 1Approved l 105.06.2018 1 1 16 胃 両 慇ν “ げ∝H″AM夕 麗 蕊 蕊 蔦 y― 閣 需 面 而 戸 「
experts and it was decided to rati[ the ad-hoc input output norms under para4.7 of HBP as per details below or as
iapplied by firm whichever is lower :
Export Product
Qty.
SI.No.
Import items
Quantity
allowed
ABEERS WEIGHT
BALANCE CAPSULES
(MEDICAMENTS OF
AYURVEDIC SYSTEM
)
910000.000
Number
1
Guggul (Commiphora mukul)
- herbal extract powder
127.5
mゴcapsule
う
４
Fenugreek (Trigonella
foenum graecum) - herbal
extract powder
127.5
mg/capsule
3
Bishops weed
(Trachvspermum ammi)
127.5
mg/CaDSule
1 1
| |
herbal extract Dowder
4
Gymnema (Gymenma
syvestre) - herbal extract
powder
127.5
mg/capsuに
Piper longum ( herbal extract
powder )
127.5
m2/capsule
:RA concemed may take負
“
her necessary action as per above decision ofNC
ICase No.:198/5/82¨ ALC4/2015 ParけName:SHASUN
IPHARMACEUTICALS
ILIMITED
Meet No/Date:3/82-
IALC4/2018
10506.2018
IHQ File:01/82/050/00338/AM16/IRLA File Lic.No/Date:0410159704 1 1
:04/24/040/00205/AM15/ 111.11.2014
1)ecisio■ : Committee considered case as per agenda and deliberated on the matter Jl the presence ofthe technicall
experts and it was decided to rati″
the ad_hoc input output norFnS under para 4.7 of HBP as per details bclow or as
l^^^1:^月
■、′
`…
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:‐
1^.、,^_ .
'applied by firm whichever is lower :
Export Product
Qty.
SI.No.
Import items
Quantity
allowed in ke
IBUPROFEN LYSINE
GRANULES(IN
HOUSE)
1600.000
kg
1
IBUPROFEN LYSINATE
POWDER
1616 kg
う
ん
ISOPROPYL ALCOHOL
1293 kg
RA concemed may takc funher necessary action as per above decision ofNC
ICase No.:65/15/82¨ ALC4/2014 1ParりName:ABEERS
Ｆ
Ｉ
Ｉ
Ｉ
＾
や
―
―
:PHARMACEUTICALS PVT
‐ :LTD
IHQ File iRLA Flle
101/82/050/01352/AM15/ 1:05/23/040/00360/AM15/
'Mcet No/Date:3/82-
ALC4/2018
05.06.2018
IStatus:Deffered
‐
and Re… lndexed
lDefer
Date:05.06.2018
ILic.No/Date:0510392011
1411.2014
I
Decision : It was decided to cali the firm for personal hearing to e
I
xplain their case
「
‐Case No.:112ん/82-ALC4/2015
猛鰈
雉
D.
IMeet No/Date:3/82‐
ALC4/2018
,05.06.2018
1Lic.No/Date:0310793039
119.01.2015
Status:
Approved
|
experts and it was decided to ratify the ad-hoc input output norrns on net to net basis as both the export and import,
items are pharmacopeia grade.
;RA concerned may take further necessary action as per above decision of NC
Meet No/Date:3/82-
ICase No。:82ノ18ノ82‐ALC4/2014 ParりName:ABEERS Meet No/Date:3/82- Status:Deffered
‐ | IPHARMACEUTICALS PVT IALC4/2018 and Re―
indexed
l l lLTD o5.06.2018 1
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Status:
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Status:
Approved
猛
:RLA File
103/95/040/00812/AM15/
I I Case No.:88/5/82- ALC4/2015 lparty Name:ABEERS
…
「
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uTICALS PVT~剛
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1HQ File lRLA File iLic No/Dtte:0510392949 :Defer
l:01/82/050/00228/AM16/ 1:05/23/040/00486/AM15/ 121.01.2015 1Date:05.06.2018
;Decision : Committee considered case as per agenda and deliberated on the matter in the presence of the technical
iexperts and it was decided to rati$z the ad-hoc input output norrns under para 4.7 of HBP as per details below or as
applied by firm whichever is lower :
Export Product
Qty.
SI No.
Import items
Quantity
allowed in kg
ABEERS WEIGHT
BALANCE CAPSULES
(MEDICAMENTS OF
AYURVEDIC SYSTEM
)
668228.000
Number
1
Guggul (Commiphora mukul)
- herbal extract powder
85.2 kg
う
４
Fenugreek (Trigonella
foenum graecum) - herbal
extract powder
85.2 kg
Bishops weed
(Trachyspermum ammi)
herbal extract powder
85.2 kg
4
Gymnema (Gymenma
syvesffe) - herbal extract
powder
85.2 kg
5
Piper longum ( herbal extract
powder )
85.2 kg
RA concemed may take irther necessary ac●on as per above decidon ofNC
: ` p5.06.2018 1
1 1
:
:
l:3424rc40rc02951{M151 116.02.2015
l
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jevnerrc cnd ir wnq decided to ratifu the ad-hoc innrrt orrtnrrt norms under oara4.7 of HBP as ner details below or as'
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11
Export Product
Qty.
Sl.No.
Import items
Quantity
allowed in kg
SorbylAcetate
l kg
1
Sorbic Acid
0.888
2
Vitride
Not allowed
iRA concerned may take further necessary action as per above decision of NC
Export Product
Qty.
Sl.No.
Import items
Quantity
allowed in kg
DARUNAVIR
l kg
1
rs.s、_Boc Eooxide(or)tert―
1.12
5
i
|
11 1
I
CaseNo.:61/17182-ALC4/2016 lPartyName:MYLAN
LABORATORIES LIMITED
IMcet No/Date:3/82‐
IALC4/2018
105.06.2018
,Status:
Approved
IHQ File:01/82/050/01022/AM17/IRLA File
l :09/24/040/00607/AM15/
ILic No/Date:0910061652
126.02.2015
.13 lDecision : Committee considered case as per agenda and deliberated on the matter in the presence of the technical ,
I
- - lexperts and it was decided to ratifi the ad-hoc input output norms under para 4.7 of HBP as per details below or as ,
,applied by firm whichever is lower:
ETHANOLATE
butyl-( I S)- I -[(2S)-oxiran-2-
yll -2-phenylethylcarbamate
(or)
(2S,3 S)- 1,2-Epoxy-3-(Boc-
amino)-4-phenylbutane (or)
(2s,3 s)- I ,2-epoxy-3-
(butoxycarbonyl)amino-4-
phenyl butane [(S,S)-BOC
Epoxidel
2
Isobutyl amine
1.648
3
P-Nitrobenzene sulfonyl
chloride
1.04
4
(3R,3aS,6aR)―
hexahydrofuro[2,3-b]缶an‐3-
y14-nitrophenyl carbonate
(or)Nitrocomplcx(DAR¨
IIA)
0.656
Act市ated Carbon(ENO― PC)
0.100
6
Methanol
5.37
7
Triethylamine
0.40
Triethanolamine
0.034
9
NMPO (or) N-Methyl
pyrrolidone
416
10
Methvlene Dichloride
682
Isooroovl alcohol
4.94
||| |
| IRA concemed may take hrthernecessary ac●on as per above decision ofNC
」
Mcet No/Dtte3/82-
:ALC4/2018
105.06.2018
Lic No/Date:0910061664
'04.03.2015
Status:Deffered
and Re-indexed
―
|
Defer
Date:05.06.2018
:experts and it was decided to ratifu the ad-hoc input output norms under para 4.7 of HBP as per details below or as
_ _ applied by firm whichever is lower :
l5
Export Product
Qty.
Sl.No.
Import items
Quantity
allowed in kg
PERINDOPRIL
ERBUMINE
l kg
1
(2as,3as,7as)OCTAHYDRO
INDOLE-2-CARBOXYLIC
ACID
0.947
つ
４
L―NORVALINE
1.423
l
I ICase No.:10`/7/82-ALC4/2015
1161
ParりName:ALCHEMIE
LABORATORIES
,Meet No/Date:3/82-
IALC4/2018
105.06.2018
ｄ
一
ｍ
¨
; :
ヽCase No.:72/4/82-ALC4/2015
Paty NameiLANTECH
IPHARMACEUTICALS LTD
11
14 1HQFile ~~~
RLA File
101/82/050/00111/AM16/
iDecision : Deferred for comments of TE
ICase No.:447/5/82-ALC4/2015 Parり
Name:AARTI
INDUSTRIES LIMITED
Meet No/Date:3/82-
ALC4/2018
0506.2018
Status:
Approved
IRLA File
l:03/94/040/01131/AM15/
12.03.2015
7
|い
お揃たシ636んbケiルAMi´ 揉LA Fi3 ~‐
~|お
ヽルb農よ6bibウ04め
,~~~|
1 103/94/040/00812/AM15/ 116.03.2015 1 1
:Decision:Commhcc considercd casc as per agcnda and deliberated on the matter in the presence ofthe technical
leXpettS and it was decided to ratl～
the ad― hoc input output norms under para 4.7 ofHBP as per details below or asl
lapplied by nrm whichever is lower:
Export Product
Qty.
Sl.No.
Import items
Quantity
allowed in kg
ETHYL BENZYL
ANILINE SULPHONIC
ACIDE(N― ETHYL― N―
(3SULPHOBENZYL)
ANILINE
l kg
1
1.(a)aniline
0.555
つ
ん
(b)ETHYL ALCOHOL
DENATURED(95%)
0274
3.BENZYL CHLORIDE
0.600
4.CAUSTIC SODA LYE(46%
W/W)
0.480
J
IRA concerned may take further necessary action as per above decision of NC
iCase No.:65/4/82-ALC4/2015 1Pa」
りNamc:MYLAN
卜 三けお面赫剛岬
D
IRLA File
l′ IHQ Filc lRLA File
1 101/82/050/00104/AM16/ .:09/24/040/00662/AM15/
'Decision : Deferred for comments of TE
Meet No/Datei3/82-
‐ALC4/2018
‐05.06.2018
Status: Deffered
and Re-indexed
Defer
:Lic.No/Date:0910061843
131.03.2015
IDate:05.06.20181
|
l iCase No.:73/4/82-ALC4/2015 Paty Name:VIVIMED LABS
‐LIMITED
118 HQ由8… … ………tAnだ…… ∴
~
1 101/82/050/00H2/AM16/ 1:09/24/040/00700/AM15/
.Mcet No/Date:3/82-
ALC4/2018
105.06.2018
ILic.No/Date:0910061821
31.03.2015
us:Deffered
Re-indexed
Defer
Date:05.06.2018
TT¨ぼ剛臨~1顆r~師¬
1 105.06.2018
IHQ File:01/82/050/00119/AM16/1RLA File lLic.No/Date:0910061882 1 1
1 1:09/24/040/00652/AM15/ 115.04.2015 1
‐
:Decision:Commi■ee considered case as per agenda and deliberated on the ma■
er in the presence ofthe technicall
:Decision : WC to be taken
te*perts and it was decided to ratifu the ad-hoc input output norms under para 4.7 of HBP as per details below or as,
)applied by firm whichever is lower :
Export Product
Qty.
Sl.No.
Import items
Quantity
allowed
TETANUS
ANTITOXIN IHS/BP
10001U/15001U/ML(IN
THEFORM OF
PFS/VIALS l ML
EACH)
590000.000
Number
1
TETANUS ANTITOXIN
30001U/ML
384 2 1itre
.
iRA concerned may take further necessary action as per above decision of NC
19
120 iCase No。:129/7/82¨ ALC4/2015
IPa●y Name:NATIONAL TUBE
′
01
lralty lNa11lo lN′
IINDUSTRIES,
器λ蠍OЮ∞霧晨Ⅲα l悧鼎α“Ю
""Ю
B鮨お
5Ю6知8
Decision : Committee considered the case as per agenda and it was decided to call from the firm complete
,technical details as per appendix 4E for each export product separately and calculation sheet to axis of raw
material.
1器晶児
5υ00734ハMlα
ICase No.:97/8/82‐ ALC4/2015 Paty Name:ASCENT
1 lFINECHEMPVT.LTD.,
| |
liOliおibi/8夕bζ5/oo893/AMigァ:良LA Fi` ‐
:RLA File lLic.No/Date:0310795930 1Pefer l
Mcet No/Datei3/82-
IALC4/2018
105.06.2018
1Lic.No/Date:0810135338
istatus:
'Approved
つ
４
108/24/040/00051/AM16/ 122.05.2015
1)ecision : Comnlittee considered case as per agenda and deliberated on the mattcr in the presence of the technical
,experts and it was decided to ratifr the ad-hoc input output norms under para 4.7 of HBP as per details below or as
applied by firm whichever is lower :
Export Product
Qty.
Sl.No.
lmport items
Quantity
allowed in ks
N―(3-
AMINOPROPYL)
IMIDAZOLE
Clear Colorless to Pale
Yellow liquid
l kg
1
IMIDAZOLE
white offwhite crsytals
0.775 kg
2
Sodium Methoxide
White Powder
0.740 kg
iRA concerned may take further necessary action as per above decision of NC
獅
「五
:満・
'乃
782‐ALC4/2015 1Party Nallle:SUN IMeet No/Date:3/82-
Status:
Approved
~1
駐L話語霊了
~~
IHQΠ
LЮ 1/82Ю 5υ00622/AMlα
l職ち刷:OЮ0078/AMlα
う
‘
う
４
1譜どち品
lα
0510394418 1
IDecision:Committee considered case as per agenda and deliberated on the matter in the presence ofthe technical l
experts and l was decided to ratl～
the ad_hoc input output norrns under para 4.7 ofHBP as per details below or as l
lapplied by firnl whichever is lo、
ver:
I Export Product
Clanthromycin Carbomer GranuLs 43.5%/43.75%/44%…
…l kg
S.NO.
Import Items
Norms recommended for export of I kg
1
Clarithromycin
Or its raw material as per SION A-2263 on
p4r-rata basis
0.4394 kg
つ
４
Carbopol 974P
0。370 kg
RA may take appropriate action as per the decision of No.rns Committee.
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1 applied by flrm whichever is lower:
8
105.06.2018
:
:RA concemed may takc hrther necessary action as per abovc decision ofNC
1
Export Product
Qty.
Sl.No.
Import items
Quantity
allowed
CAL‐ SUP TABLETS
(CALCIUM CARBONATE
1250 MG+GLYCINE
535.7 MG)
Numbers
1
GLYCINE USP/BP/EP
535.7mノtablet
2
CALCIUM CARBONATE
DENSE BP/USP
1275 mgltablet
ICase No.:24/13/82-ALC4/2016
IMeet No/Date:3/82‐
:ALC4/2018
Status:
,Approved
105.06.2018
124
|
IPaty Name:ARENE LIFE
ISCIENCES LIMITED.
1
:HQ File:01/82/050/00652/AM17/:RLA File lLic.No/Date:0910062155 1
1 1:09/24/040/00034/AM16/ 110.06.2015 1
1Decision:Committee considered case as per agenda and deliberated on the mater in the presence ofthc technical
leXperts and l was decided to ratitt the ad― hoc input output norms under para 4.7 of HBP as per details below or as
,applied by flrrn whichever is lower:
Export Product
Otv
Sl.No.
Import items
QuantiW allowed
DARUNAVIR
lkg
1
(2S,3S)-1,2-EPOXY‐
(BOCAMINO)-4-
PHENYLBUTANE
1.40 kg
2
ISO BUTYL AMINE
0.854 kg
4‐ACETAMIDO BENZENE
SULFONYL CHLORIDE
1.30 kg
4
Carbonic acid, 2,5-dioxo- I -
pyrrolidinyl [(3R,3aS,6aR)-
hexahydrofuro [2,3 -b] furan-
3yll ester (Carbamate)
0.598 kg
5
Methvlene Dichloride
6.00 kg
:| |
|
:RA concemed may take nirther necessary action as per above decision ofNC
i Case No.:48/19/82-ALC4/2015 Pa口りName:RAJ IMeet No/Date:3/82-
1 ,DHANVANTRY PHARMACY IALC4/2018
:Status:
lReject
|
ィ
nANVAN■
ヽ■rnA氏
ⅣlAし
工
1詰
濾
猫
∵
| :
|
IHQ File:01/82/050/01529/AM16/IRLA File lLic.No/Date:2410041748 1
124/24/040/00007/AM16/ :15.06.2015 ,
125
1
|
Decision : Committee considered the case as per agenda and it has been observed that the Oescilption ot
,export is very generic and mentioned as sweetness it does not specify 7o content of import item committee
:not in position to allow the inputs claimed by the firm. It was decided to reject the case.
IRA concerned may take further necessary action as per above decision of NC
| で
1:もヽ二ど
iたJみ ~■おNa品よbAN61責AkM~lMeよヽルb圧晶た
'1~~SittIIζ
Ap`1613b l
l lALC4/2015 'CHEMICALS PRIVATE LTD.:ALC4/2018 1 1
105.062018 1 1
ち6鳥蹴
5剛∞″AMα
器
蹴
0側wAttγ ttT1lΨ
7_|__ |
| IDecislon:Committee considered case as per agenda and deliberated on the matter in the presence ofthe technicall
l lexperts and it was decided to ratitt the ad‐ hOc input output norms under para 4 7 ofHBP as per details below or as
lapplied by arln whtheverおlower i
9
10
「
IRA concerned may take further necessary action as per above decision of NC
Export Product
Qty.
Sl.No.
Import items
Quantity allowed
in kg
2-Amino 5-Nitro
Benzophenone
lkg
1
Ortho Chloro Benzoic Acid
1.16
2
Dimethyl Formamide
0.32
Tetrahydrofuran
0.50
4
Dirnethvl sulphoxide
080
Hydrazine Hydrate
0.31
6
Isopropyl Alcohol
0.66
| ICase No.:50ノ8/82‐ ALC4/2015 1ParりName:PUSILIN
I I IBIOTECHNOLOGY PVT.LTD.
1 1
'7 1HQFile ~…
………~~―
1遮扇稿…………~―‐…――
| 101/82/050/00846/AM16/
:06/24/040/00014/AM16/
IMcet No/Datc:3/82‐
:ALC4/2018
105.06.2018
Lic.No/Date:0610038189
:0907.2015
Status:Deffered l
land Re‐ lndexed l
lDefer l
lDate:0506.2018‐
Decision : Deferred for comments of DBT
‐
## Case No.:20/16/82‐ ALC4/2015
IPaty Name:MYLAN
ILABORATORIES LIMITED
IMeet No/Date:3/82-
IALC4/2018
105.062018
1Lic.No/Date:0910062338
115.07.2015
Status:Deffered
and Re-indexed
Defer
Date:05.06.20 t 8
響Q「ilさ~~~‐ =LA儡~
n1/oぅ/Aくn/nl●Иn′ Aヽガ1`′
｀_Aハルヽ′′A′ ^′^^A^
:01/82/050/01340/AM16/
1Decision:Deferred for r
6/ 1:o9/24/040/0003`
14/040/00032/AM16/
lDecision : Deferred for comments of TE
## Case No.:22ノ13/82-ALC4/2015 1PartyName:BLISS INDASl lMeet No/Date:3/82‐ lstatus:
| ILIFESCIENCES PVT LTD IALC4/2018 ,Approved
ヽ 1 105.06.2018 1
青O fii8161/82/0`0/ob085'AMi`′ IRLAFile…
…
‐
titヽ
6′biもbbi6わ,お3 1
‐~~'
1 103/94/040/00282/AM16/ 117.07.2015 1
1Decisio■:COmmhee considered case as per agenda and delibcratcd on the matter in the presence ofthe technical
:|:織ミな
観::lrl:響lea“
hoc hp■o耐p耐noms und∝ptta 47 of HBPぉp∝ddtts bdow∝器
Export Product
Qty.
Sl.No.
Import items
Quantity
allowed in ks
VANCOMYCIN
HYDROCHLORIDE
STERILE USP 540 MG
vial
150000.000
Number
1
VANCOMYCIN
HYDROCHLORIDE
STERILE USP(POWDER)
80.740 kg
RA concemed may take further necessary action as per above decision of NC
¬
29
I｀
:" iuQ Fite:ot/82/050/01078/AMrOl inra fil;
*
I
::03/941040100038/AMt6/
Meet No7/Date:3/82-
IALC4/2018
105.06.2018
1Lic.No/Date:0310797627
124072015
rStatus:
Approved
I)ecision:Committee considered case as per agenda and deliberated on the matter in the
presence of the technical
11
⌒
1電堅型翌翌賓
ad_h° C input output norlns under para 4.7 of HBP as per details below or asl
IRAconcemedmaytakenlrthernecessaryactionasperab9VedecisionofNC
」
Decision : Committee considered case as per agenda and deliberated on the matter in the presence olthe technical
rexpefts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as
lapplied by firm whichever is lower :
Export Product
Qty.
Sl.No.
Import items
Quantity allowed
in ke
TEBUCONAZOLE TECH
ALPHA
(2-4-
CHLOROPHENYLETHYL
ALPHA,1,1-DIMETHYL‐
ETHYL,1+1‐ 124
TRIAZOLE)
lkg
1
DIMETHYL SULFIDE
0.16
2
DIEPENTANE
0.81
3
N N DIMETHYL
FORMAMIDE
0.15
4
POTASSIUM HYDROXIDE
0.47
5
1,2,4 TRIAZOLE
0.30
6
CYCLOHEXANE
0.19
rRA concerned may take further necessary action as per above decision of NC
」
Export Product
Qty.
Sl.No.
Import items
Quantity
allowed in
ks
ERGOCALCIFEROL ORAL
SOLUT10N USP(VITAMIN D2 1.0
T04.O MIU IN EDIBLE OIL―
SOYABEAN/CORN/ARACHIS/MCT
OIL)
l kg
1
ERGOCALCIFEROL
(VITAMIN D2)
0.0255 kg
「甲赫赫ご腎ゃ管■…尊麟I I
: | |
.
i
,05.06.2018
HQ File :01/82/050/01090/AMl6/ RLA File
Lic.No/Date:0310798205
I -
,:031941040t00878/AM15/ ,tz.Og.zOtS
l
ICase No.:12`/13/82‐ ALC4/2015
Paty Name:ASTEC
LIFESCIENCES LTD。
,
|
IHQ File:01/82/050/01089/AM16/IRLA File
l l:03/94/040/00879/AM15/
'Decision : Committee considered case as per agenda and and
under para 4.7 fHBP
details below
lied by firm r
132
鳩
一
decided to ratify the ad-hoc input ou
whichever is lower no repeat one timt
tput norms under para 4.1 ot Hl3P as per detalls below or as app
l basis only:
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed in kg
DEXTRINOL
l kg
1
CROTONIC ACID
0.849 kg
つ
‘
BUTADIENE
0 629 kg
The above norms is allowed for one time basis and no repeat licence allowed
RA may take appropriate action as per the decision of Norms Committee
IMeet No/Date:3/82- IStatus:
IALC4/2018 1Approved l
105.06.2018 1 1
33 1Case No.:116/16/82-ALC4/2015 ParりName:PANERA BIOTEC Meet No/Date:3/82-
Status:
ILic.No/Date:0310798319
120.08.2015
12
==………～
………
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`jl
: :
‐
,
: : l p5.06.2018
ミ :
:IHQFilよ山面
TTttI`7~‐鷺芳
j蕊鳳ユ|ごIti躍IT?■■lli
l ,“ Iお11,OmmiⅢIⅢ通品三菰姦
:ⅢⅢndattdddberaedOn■e matter h me presence of me“ ch」cJ:
ヽ ■ 9~ ~~~~~~ ――――――――――――――
^―
^^^― マ‐―^ ^^^‐‐
^― r^―――
^^― ―v^●‐‐ツ■‐ツ^^^^^v¨ ●
:
|:X[1:ξ
:111:131]1お1」勇富?』livλ歯1°
C input Output norlns r aS applied by flrrn under para 4.7ofHBPOnei
:RA concemed may take further nccessary action as per above decision ofNC i
| :RA concemed may take further nccessary action as per above decision ofNC i
‐―
‐
―
―
…
… ……
…
‐― ‐
‐‐ ― … … ^‐
―
―
―
― ‐ ‐
‐ ―
― ―
―
‐… ― ――
‐
‐
‐
‐ ―
‐‐
‐
‐‐
― ―
―
… ― ‐
‐ _ __′
^_
、―
‐
‐ ―
―
― ―
´―
―
―
‐ ‐
―
―
‐
―
‐
― ¨
:
ICase No.:124/7/82¨ALC4/2016
|
1
1
IHQFile16i′
82/050/00う58/AMi'ア|
恐龍屯
:魂轟全
I鷲鷺
i::…
…
…
1営乱厖ヤ諸話
:夕慧
タ
:
●062018
1跳ち刷,OЮ0424/AMlα
Export Product
Qty.
Sl.No.
Import items
Quantity
allowed in ke
3,4,5 TRIFLUORO
BROMO BENZENE
l kg
1
2,3,4 TRI FLUORO ANILINE
0.86 kg
つ
４
SODIUM HYPOPHOSPHITE
0.23 kg
1 嘉」ζ
き
Nol'I七ウ′
i4/82:Aic4わblζ
HQ File:01/82/050/01293/AM16/
applied by firm whichever is lower :
Export Product
Qty.
Sl.No.
Import items
Quantity
allowed in ke
N‐OCTYL― D‐
GLUCAMINE
l kg
1
N-OCTYL AMINE
0.825 kg
flrln whichever is lower:
|
:l l l l
lこA concemed may take arther necessary action as per above decision ofNC
,Paty Name:AETHER
INDUSTRIES LIMITED
File
:Meet No/Date:3/82¨
:ALC4/2018
105.06.2018
ILic.No/Date:5210041630
11009.2015
:Approved
:Decision:Committee considered case as per agenda and delibertted on the matter in the presence ofthe technicali
～
Xp響l響彎t WalttCmed10 rati″ the ad_hoc mput。■put norms under ptta 4.7 ofHBP as per detdls bdOw Or asl
iappliedbyfrmwhicheveris lowei: ^
・ ~r_―
―
―― 一^一r^― ― … ‐ν～"V`‐‐′
|
13
ICase No.:79/14/82-ALC4/2015 :Parり
Namc:ABEERS iMect No/Date:3/82- iStatus: |
IPHARMACEUTICALS PVT :ALC4/2018 :Approved l
Export Product
Qty.
Sl.No.
Import items
Quantity
allowed in
mg/600 mg
tablet
GABAPANTIN
TABLETS USP 600
MG
10800000.000
Number
1
GABAPENTIN USP
612
つ
４
MANNITOL(PEARLITOL
100 SD)USP/NF
915
COPOVIDONE/PLASDONE
S‐630 USP/NF/Ph.Eur.
30.0
4
POLOXAMER(LUTROL
M127)NF
1.00
MAGNESIUM STEARATE
VEG.EP/USP/NF
2.00
6
HYDROXY PROPYL
CELLULOSE NF/Ph.Eur
(KLUCEL EF Ph.)
30.00
7
LOW SUBSTITUTED
HYDROXY PROPYL
CELLULOSE USP/NF/JP
1000
RA concerned may take further necessary action as per above decision ofNC
ILT5 ~~~ ~~ :碩
屁:ふU :^^rr~~~ |
HQ File:01/82/050/01215/AM16/IRLA File lLic.No/Date:0510395773 1 1
105/23/040/00274/AM16/ 13009.2015 1
Decision:Committee considered case as per agenda and deliberated on the matter in the presence of the technical
experts and it was decided to ratltt the ad‐ hoc input output norms under para 4.7 of HBP as per details below or as
applied by flrm whichever is lower i
Export Product
Qty.
Sl.No.
Import items
Quantity
allowed (Per
capsule)
ABEERS LIPID CARE
CAPSULES(
MEDICAMENTS OF
AYURVEDIC SYSTEM)
lNumber
1
Ariun (Terminalia ariuna)
102 0 mg
2
Fenugreek (Trigonella
foenum graecum)
102.0 mg
Turmeric (Curuma longa)
102.0 1ng
4
Gymnema (Gymenma
sylvestre)
102.0 mg
Black Pepper (Piper nigrum)
102.O mg
6
Long pepper (Piper longum)
102 0 1ng
,RA concemed may take further necessary action as per above decision ofNC
## Case No.:1`4/14/82-ALC4/2015 ParりName:AASHA B10CHEM IMeetNo/Datc:3/82- Status:
:ALC4/2018 1Approved
'05.06.2018 :
HQ File:01/82/050/01300/AM16/:RLA File lLic.No/Date:1010059293 1
110/24/040/00049/AM16/ :12.10.2015 :
'Decision : Committee considered case as per agenda and deliberated on the matter in the presence of the technical ,
'experts and it was decided to ratify the ad-hoc input output norms as applied by firm under para 4.7 of HBP. One ;
Itime basis only no repeat licence allowed.
37
| |
14
Ｆ
‐
３
９
| IRA concemed may take仙山er necessary action as per above deddOn ofNC I
|
itthJ‐
網ZAL∽
劉5讐
ギ
獅αLACT∝Щ NDIAp誓
翻
r“
般―
響
為ed
10品i励650/Olb97/AMl∂脇鯛
i10ふli↓i」
~ォ蕊漁子携ぬわ。
5611~
experts and it was decided to ratifu the ad-hoc input output norrns on net to net basis under para 4.7 of HBp one
time basis only no repeat licence allowed.
IRA concerned may take further necessary action as per above decision of NC
Case No。:116/13/82‐ ALC4/2016
Pa■y Name:SOFTGEL HEALTH
ICARE PVT.LTD.,
Decision : Deferred for comments of TE
Mect No/Date:3/82-
:ALC4/2018
:05.06.2018
IRLA File
104/24/040/00143/AM16/
ILic.No/Date:0410161132 1Defer
120.102015
IDate:05.06.20181
」
…
|
Status:Deffered
and Re-indexed
101IHQ File
101/82/050/00744/AM17/
Ⅲ:t｀1■8/21/821赫も
I」
.:みNa高ま宙｀も~… … ‐
lMeまヽルb農よ」滝,1~~,sta■ζ~~
I IBIOPRODUCTS LTD., IALC4/2018 :Approved
i l 105.06.2018 1
HQ File:01/82/050/01743/AM16/RLA File
109/24/040/00442/AM16/
ILic.No/Date:0910062831 1
103.11.2015 1
,41
;experts and it was decided to ratifu the ad-hoc input output norms under para 4.7 of HBP as per details below or as
lapplied by firm whichever is lower :
Export Product
Qty.
Sl.No.
Import items
Quantity
allowed
TETANUS ANTITOXIN
IHS/BP
10001U/15001U/ML(IN
THE FORM OF
PFS/VIALS l ML
EACH)
695500.000
vials
1
TETANUS ANTITOXIN
30001U/ML
252.47 1iter
The above norms is allowed for one time basis and no repeat licence ls -dllowed-
'RA concerned may take further necessary action as per above decision of NC
iCase No.:4/20ノ82-ALC4/2015 Pa“ y Name:AIMSIMPEX PVT.IMeet No/Date:3/82¨ :status:
| :LTD., IALC4/2018 1Approved
i05.06.2018 1
| : | 105.06.2018 1
11。
両お術恵夕630/013慧7/AMi`″
鷺痣ふlij:::::な話j ~1雰斜究1よ
。
bib恵66」と3 1~~
F21もふtiol:ё 6轟
“
h“
“
五ξ通とおども基
`:ξ
`も
「:L8ida tta deiiberalta“
iぉも品五
18:ih iAもお島ξさ
hもちもrthetどhnitil
l experts and it was decided to ratitt the ad―
hOC input Output norms under para 4 7 of HBP as per details below or as
‐ applied by flrln whichever is 10wer:
Export Product
Qty.
Sl.No.
lmport items
Quantity
allowed in ke
15
COUMARIN
SALiCYLALDEHYDE
1.09 kg
i
i
RA concerned may take further necessary action as per above decision ofNC
―
１
１
コ
:03/95/040/00632/AM16/
Meet No/Date:3/82- iStatus:Deffered
lALC42018 and Re¨ indexed
105.06.2018 1
1Lic.No/Date:0310800416 1Defer
26.11.2015 1Date:05.06.2018
|
:Decision:Deferred for comments of TE
Export product
Exp.
Qty.
SI No.
Import items
Qty. Allowed in kg
6-BROMOHEXYLTRIMETHYL
AMONIUM BROMIDE
(BHTAB)
l kg
1
1,6 HEXANDIOL
1.233 kg
う
乙
HYDROBROMIC ACID
48%
3.53 kg
,RA may take appropriate action as per the decision of Norms Committee
45 D..irion : Decision : Committee considered case as per agenda and and in the presence of thelichricui-opetti,' ii,
lwas decided to ratifo the ad-hoc input output norms As applied by the firm under para 4.7 of HBP One time basis
lorly no repeat licence allowed.
l c桑きヽま:ζ
`,19/患
うLALこ″,6i3~,静
'Na話
よPANÅёEA BIOTЁ ё ,Mももiヽふ′漁
砲/821 ~ ｀tattt「~~|
1喚h面滋属面i菰詰
ユi計―
器
鰍f FTTК
d i
~~ ~:Liti｀
o/bi3:63ibjO`ぶラ
6｀ 1 ~~¨
~~i
| l i
Ю5.06.2018 : :
I HQhib″なうん3bttSi7/AMl″
‐
:RLA島お… … … ~Lもヽルbiよ63ibjO`ぶラ
6｀
|…
…
1
1.″ 1 1:05/24/040/00439/AM16/ 118.12.2015 1 1
:
―
一…
・
・
・
―
―
耳
T~~~
´ ___ ~ ~
Status:
Approved
:
iCaseNo.:2/1/82‐ ALC1/2016
|
Paty Name:UNlJULES LIFE
SCIENCES LTD.
И
付
IHQ File
l:01/82/050/01776/AM16/
RLA File
ICase No.:5/1/82¨ ALC1/2016
IHQ File:01/82/050/01779/AM16/RLA File
:Lic.No/Date:0310800551 1
101.12.2015 1
'
iDecision : Committee considered case as per agenda and and in the presence of the technical experts, it was
.t
,decided to ratifo the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm
44 ,whichever is lower:
ParサName:NEOGEN
,CHEMICALS LIMITED
IMeet No/Date:3/82‐
lALC4/2018
105.06.2018
Status:
Approved
` ICase No.:66/1/82-ALC1/2016
`71
Pany Name:BTL EXPORTS PVT.IMeet No/Datei3/82-
:ALC4/2018
105.06.2018
ILTD,
)cided to rati0/ the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied
hichever is lower:
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed in kg
Saccharin
l kg
1
Sodium Saccharin
1.15 kg
16
|
Oecision : Committee considered case as per agenda and deliberated on the matter in the presence of the technical
experts and it was decided to ratifo the ad-hoc input output norms on net to net basis under para4.7 of HBP one
Itime basis only no repeat licence allowed.
ICase No.:17/10/82-ALC4/2016 ParりName:IND― SWIFT
ILABORATORIES LTD。
,
IMeetNo/Date:3/82- Status:Deffered l
lALC4/2018 and Re¨ indexed l
105.06.2018 1 1
191鵠駆λ
::::嘉I↓∴~
場が
::OЮ 0104/AMlα
ILic.No/Date:2210015407 :Defer
i01.02.2016 1Date105.06.2018
iDecision : Committee considered case as per agenda and deliberated on the matter in the presence of the technical
rexperts and it was decided to rati! the ad-hoc input output norrns on net to net basis under para 4.7 of HBP one
,time basis only no repeat licence allowed.
i
tRA concerned may take further necessary action as per above decision of NC
■1基8｀二69/i/82-ALc1/201`~ルみヽ1品赫
―
―一
M品
ヽo/D猛きも
'慧
が
~‐
‐
ヽ111lζ :b3fferedi
‐ | IETHICALS PVT LTD :ALC4/2018 1and Re―
indexed l
pl蘇
而
―
―
―
―
―
―― IDTA HI ~~~躍
軍
宴
高
高
群
41「
__:
『
漱釉
|"edJon DL~… … ~……… …
IPatt N鳳
`bFiiMuS b良
むこS IMc81ヽ6′ bitも:b′jタ
IPRIVATE LIMITED IALC4/2018
Status: Deffered
and Re-indexed
.^ Case No.:79/7 182- ALC4/2016
)z
iHQ File:01/82/050/01840/AM16/IRLA Flle
l ::03/94/040/00831/AM16/
:Lic.No/Date:0310801850
118.01.2016
,Case No。:68/1/82¨ ALC1/2016
Party Name:BTL EXPORTS PVT.
:LTD,
IMcet No/Date:3/82¨
:ALC4/2018
10506.2018
Status:
Approved
48
IHQ File:01/82/050/01842/AM16/IRLA File
:Lic.No/Date:0310801927
120.01.2016
ICase No.:43/1/82‐ ALC1/2016
ParサName:AARTI
INDUSTRIES LIMITED
IMcet No/Date:3/82-
lALC4/2018
105.06.2018
Status:
Approved
17
asc No.:13/10/82-ALC4/2016 Party Name:IND―
SWIFT
ILABORATORIES LTD,
:ALC4/2018
10506.2018
‐Status:Deffered
‐and Re-lndexed
l Defer
l Date:0506.2018
.Decision : It was decided to call the firm for personal hearing along with all technical details to explain their
,
lcase before the committee.
| ,Case No.:82/7ノ82‐ALC4/2016 1Party Name:OPTIMU毯5RUGS IMもしtヽo/b:tも:」/82- Status:Deffered
i : IPRIVATELlMITED :ALC4/2018 iandRe¨
indexed
i :05.06.2018
稀蕊蕊蕊
「
鳩編鷺一聯…
F――
―
## case No.:50 t2t82-ALC4n2u6
fffi.X5r..,tANERA
BIoTEC [r;:t){?;e:3t82- ifiH".
05.06.20 r 8
HQ File:01/82l050/00050/AMl7/ RLA File
Lic.No/Date:0510397827
:05/2410401005971A}i4161
'04.03.2016
55 Decision : Committee considered case as per agenda and deliberated on the matter in the presence of the technical
l
iexperts and it was decided to ratify the ad-hoc input output norrns as applied by the firm under para 4.7 of HBP one
I
itime basis only no repeat licence allowed .
| IRA concemed may take hrther necessary action as per above decision ofNC
lb..t.tr, t a"r*itt";;rtia*A.ur. urE. ug.rar-unO unA in tt. pr.r.n". of tt. t""hri;"I *p..tr,- it was
f11111
ldecided to ratiff the ad-hoc input output norms under para4.7 of HBP as per details below or as applied by
lwhichever is lower:
GABAPENTIN TABLETS USP
800 MG
GABAPENTIN USP
Mannitol (Pearlitol
Copovidone/Plasdone S―
6301」SP/NF/Ph.Eur
Kolliphor P 407 Micro
MAGENSIUM
STEARATE VEG.
EP/USP/NF
⌒
| :
:05.06.2018
|
園FIぎ~………
IRLA File
:Lic.No/Date:0910063240
:10.02.2016
IDefer i
l Date:0506.20181
:01/82/050/00253/AM17/
:Decision:Deferred for comments of TE
IRLA File
101/82/050/00359/AM17/
117.02.2016
iCase No.:66/4/82¨ ALC4/2016
Party Name:STRIDES SHASUN
ILIMITED
２
Ｄ
ａ
‐
８
８
¨
¨
¨
Status:
Approved
156
HQ File:01/82/050/00129/AM17/ ‐RLA File
ILic No/Date:0410161685
104.03.2016
Export product
町
Ｑ
ｔ
ｙ
．
Sl.No.
Import items
Qty Allowed in
mg/tablet
Number
816.0
2
120.0
40_0
4
10.00
10.00
18
6
Hydroxy Propyl CcHulose
NF/Ph.Eur(Kluccl‐ EF
PH)
60.00
7
Low substituted Hydroxy
PropyI Cellulose USP
NF.JP
20.00
and Re-indexed
IDefer
lDate:05.06.2018
,
,Decision : Committee considered the case as Der asenda and it was decided t,
: |
he case as per agenda and it was decided to ask the firm to furnish l
'information regarding any other Brand is mentioned may be clarified within 15 days.
― ― ‐
⌒
| ICase No.:67/4/82-ALC4/2016 1Paty Name:STRIDES SHASUN Meet No/Date:3/82- IStatus:Deffered:
声
lYITED I諸謄盤f 「
nd Re‐ hdexedi
l_|「 戸 :
l pecおbn:DeLrred br comments of TE ~~~ :
‐
lCase No.:55/4/82¨ IParりName:ENCUBE IMeet No/Date:3/82-
1
冷
LC42脱6 fTⅢ
CALSPVTLTD I紺
認鶴ぜ
58 障Oiお ~~ =LA iお
~L`:No'5表
よ梅ibttδbi,i
1 101/82/050/00H8/AM17/ :03/94/040/01044/AM16/ 109032016
## Case No.: 186 ll0l82-ALC4/2016 ParN Name:VOVANTIS
i
LABORATORIES PVT LTD
| |
59 1HQ File RLA File
l 101/82/050/00532/AM17/ 1:34/24/040/00290/AM16/
Lic No/Date:3410042021
130.03.2016
1o..iiion,C;;;iii;; consioereo
rManufactu ring Licence.
the case as per agenda and it was decided to call from
'Case No.:43/4/82¨ ALC4/201`
P霞けName:AARTI
ENDUSTRIES LIMITED
|
Meet No/Datei3/82-
IALC4/2018
10506.2018
rStatus: Deffered
land Re-indexed ,
:l
:nefe.
-
j
Date:05.06.20181
―
|
601五。rii`
| |:01/82/050/001(
RLA File
Lic.No/1Date:0310803663
'31.03.2016
| |:01/82/050/00106/AM17/
103/94/040/01108/AM16/
Decision :Deferred for comments of TE
|
## Case No.:138/7 182-ALC4/2016 Party Name:ALTA
IHQ File:01/82/050/00312/AM17/1RLA Flle
::03/94/040/01112/AM16/
:LABORATORIES LTD.
IMeet No/Date:3/82-
:ALC4/2018
105.06.2018
ｄ
∬
Ｏ
Ｖ
Ｓ
ｔ
ａ
ｔ
ｕ
枷
Lic.No/Date:0310803707
101.04.2016
「
iDecision : Committee considered case as per agenda and and in the presence of the technical
expefts,
一
|
161
it was
by firm
;ided to rati$/ the ad-hoc input ou
ichever is lower:
tput norms under para 4.7 of HBP as per details below or as applied
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed in kg
METHYL PARABEN
l kg
1
Para Hydroxy Benzolc
Acid
0.97 kg
IMeet No/Datei3/82¨
‐ALC4/2018
05.06.2018
tStatus:Deffered
r
land Re-indexed
I
IDefer l
ⅢαO,0620181
|
19
う
４
Methanol
0.50 kg
may take appropriate action as per the decision of Norms Committee
| ICase No.:123/7/82-ALC4/2016 Pa●y Namc:AARTI IMeet No/Date:3/82- Status:Deffered l
l l INDUSTRIES LIMITED IALC4/2018 :and Re―
indexed l
l l l 105.06.2018 1 1
162●。hぉ lLA白お~ Lお
.Nも/b農も
bbf6恵bjttiう IDefer~~~|
1 101/82/050/00297/AM17/ 103/94/040/01038/AM16/ 106.04.2016 1)ate:05.06.2018‐
| IDecisio■:Deferred for comments o f TE I
ICase No.:45/7/82‐ ALC4/2016 Party Name:ASTRAL
I ISTERITECH PVTo LTD.
| |
Meet No/Date:3/82-
‐ALC4/2018
IApproved
Status:
105.06.2018
IHQ Filc :RLA File
i:01/82/050/00219/AM17/ 134/24/040/00009/AM17/
Decision: Committee considered case as per agenda and and in the
decided to ratifu the ad-hoc input output norms under para 4.7 of HBP
whichever is lower:
ILic.No/Datc:3410042064 1Defer
113.04.2016 1Date:05.06.2018
presence of the technical experts, it was
as per details below or as applied by firm
I Export Product
lNAFCILLIN FOR INJECT10N USP
NAFCILLIN FORINJECT10N USP l GM AND 2 GM
31NAFCILLIN FOR INJECTION USP
AFCILLIN FOR INJECT10N USP 10 GM
S.NO
Import Items
Norms recommended for I No. Injection
2 mg ll0 ml vial
l0 gm/100 ml vial
1
NAFCILLIN FOR
INJECT10N USP
NAFCILLIN FOR
INJECTION USP 10 GM
2350 mg
I l6l5.l0 mg
う
４
GLASS BOTTELS)
Relevant, As per packing policy.
3
RUBBER STOPPER)
RA may take appropriate action as perthe decision ofNorms Committee.
164
Export product
Exp. Qty.
Sl.No.
Import items
Qty.Allowed in
mg/宙al
Voriconazole powder for Injection
2O0mg/vial, 30ml Vial
USP
51792.000
Number
1
Voriconazole
USP
210.00
2
Kleptose
NF
3200.00
ICase No.:164/10/82-ALC4/2016
Pa■y Name:GLAND PHARMA
:LIMITED
Meet No/Date:3/82‐
‐ALC4/2018
′05.06.2018
IRLA File
ILic.No/Date:0910063540
22.04.2016
HQ
20
|
per
⌒
Vials
Glass
Relevant as per
packing policy
4
Rubber Stoppers
Rubber
Seals
Plastic
6
Filters
Plastic
Consumption not
allowed under
policy
7
Tubing
Plastic
may take appropriate action as
the decision of Norms Committee
Paty NameiFRESENIU〔
.ONCOLOGY LIMITED
ICase No.:174/10/82-A LC4/2016 Pa=y NameiFRESENIUS KABI
なり」~~餞江u餌 |
1
Approved l
I
、UD.UO.ZU16 1 1
Li`1ヽも
,bitも16Sibjうな
j,ウ | |
104.05.2016 . |
|
IHQ File:01/82/050/00520/AM17/IRLA File Lic.No/Date:0510398377
IHマrHe:u1/6z/uDU/UUうZU/AⅣl1// IKLA「Je ,Lic.No/Date:0510398377 1
1 :05/23/040/00038/AM17/ 104.05.2016 . |
Decision:Committee conddered case as per agenda and and in the presence of the techntJ expetts,l wasl
ldeCided to ratiシthe ad― hOc input output norlns undcr para 4.7 of HBP as per detdk bdow or as applおd by irml
iwhichever is lower:
Export Product
Gemcitabine Inj ections 200mg
Gemcitabine Injections I gm,
Gemcitabine Injections l.4gm
Gemcitabine Injections 2gm
S.NO.
Import Items
Norms recommended for I No. Injection
200
mg/vial
lgm /vial
1.4 gm/ vial
2 gm I vial
1
2 -D eoxy -2,- difl uoro- D -
ribofu ranose-3,5 -dibenzoate-
I -methanesulphonate (T-8).
White crystalline powder.
Assay:NLT 90.0%
1.08 mg
5.40 mg
7.60 mg
10.80 mg
2
N-Acetyl cytosine.
White or offwhite crystalline
powder. Assay: NLT 98.0%
0.77 1ng
3.84 mg
5.38 mg
7.69 1ng
VCDINI0R, l0 ml ISO Clear
Type I Tubular Glass Vial 20
mm crimp neck.
Glass Vial , tubular Capacity -
10 ml.
Relevant, As per packing policy.
4
Rubber Stopper fbr
Pharlnaceuticals I」se S 871
Lyotec 4432-
50GS3WESTARRSlMPK
SP01 0R
Rubber Stoppers for
Pharlnaceutical I」se S 87J
4405‐50/GREY EPP RS SIL l
4A
Glass Bottles Antibiotique 50
,Clear Glass Type I Neck
Finish ISO83620200.
Moulded Glass Bottle 50 ml
CapaciW
,Meet No/Datei3/82-
:ALC42018
105.06.2018
165
RA
21
（
。
―
〜
―
‐
IRA may take appropriate action as perthe decision ofNorlns Committee.
HQ File :01/82/050/00182/AMl7/ RLA File
i:04 124 I 040 I 00009/AM I 7/
Decision: Committee considered case as per agenda and and in the presence of the technical experts. it was
rdecided to ratifu the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm
'whichever is lower:
Export product
Exp.
Qty.
Sl.No.
Import items
Qty.Allowed in
mg/tablet
GABAPENTIN TABLETS USP
800 MG
Number
1
GABAPENTIN USP
816.0
2
Mannlol(Pearlitol
100SD)USP/NF
120.0
3
Copovidone/Plasdone S―
630 USP/NF/Ph.Eur
40.0
4
Kolliphor P 407 Micro
10.00
MAGENSIUM
STEARATE VEG.
EP/USP/NF
10.00
6
Hydroxy PropyI CeHulosc
NF/Ph.Eur(Klucel―EF
PH)
60.00
7
Low substituted Hydroxy
Propyl Cellulose USP
NF.JP
20.00
take appropriate action as per the decision of Nonns Committee
may
appropriate
pcr
Export product
Exp
Qty.
Sl_No.
lmport items
Qty Allowed in
mg/tablet
GABAPENTIN TABLETS USP
800 MG
Number
l
GABAPENTIN USP
816.0
2
Mannlol(Pearlitol
100SD)USP/NF
1200
「
週
~面高所輌面面下~[
|
:67
1
i
:U4/24/U4U/UUUIU/AIVII //
u).uf,.lulo
,Decision : Committee considered case as per agenda and and in the presence of the technical experts, it was
i
,-^ ,decided to ratiry the ad-hoc input output norms under para4.7 of HBP as per details below or as applied by firm,
6U whlchever rs lower:
| :Case No.:181/10/82‐ ALC4/2016 1Pa●y Name:ALEMBIC 'Meet No/Datc:3/82‐ lStatus:Deffered l
: I IPHARMACEUTICALS LTD IALC4/2018 and Re¨
indexed i
亀
hぉ
― tA品
¨
島
‐
1貯
赫
Ⅲ
蕊
鷺
| :01/82/050/00527/AM17/ :34/24/040/00021/AV
Decision : It was decided to call from the firma copy of Master Batch Formula (MBF) for each export item.
1 1 1 1 1 1υ υ°リノυ●
I′ ■ヽ■ | __==ギ
| ICase No.:8/7/82-ALC4/2016
IPattName:STRIDES SHASUN
:LIMITED
:Meet No/Date:3/82-
lALC4/2018
b5.06.2018
1聯hed
22
CopovidOne/PlasdOne S―
630 USP/NF/Ph.Eur
400
4
Kolliphor P 407 Micro
10.00
5
MAGENSIUM
STEARATE VEG
EP/USP/NF
10.00
6
Hydroxy Propyl Cellulose
NF/Ph.Eur ( Klucel-EF
PH)
60.00
7
Low substituted Hydroxy
Propyl CeHulose USP
NF.JP
20.00
may take
action as
the decision of Norms Comm
appropriate
per
⌒
169
1
rCase No.:15717182-ALC4l20l6 ,Parry Name:APEX PHARMA, Meet No/DaE jtgi-
..* 3tri"r; -
i
ALC4l2Ol8
Approved
i
I
os.oo.zots
,'-"-- --
)t
:03194/040t00122tAM17 t
12.05.2016
Decision : Committee considered case as pei agenda and and in the presence of the technical experts. it was
1糀‖
::樹R:lead~h°
c hp■ou"耐nomS under ptta 47 of HBP as per d∝Jヽbdow Or as applied by■lШ
Export product
Exp.Qty.
SI.No.
Import items
Qty.Allowed
Selamectin 6% SPOT ON, Each
pipetts contain Selamectin BP 6%
wv oR 60MG/ML (Total 32000
Boxes & 96000 Pipetts)
(3 Pipetts HS/ 1 ml in each boxes)
32000.000
Boxes
1
Selamectin APl99%
Purity
5.100 kg
RA may take appropriate action as
Decision : It was decided to ask the firm to furnish the following information:
1 i)
Complete technical details as per 4E showing complete and balance chemical reaction, molecular
weight of each reaction and output product molar requirement etc.
iD
% yield on molar basis
iiD
Production consumption data certified by CA against the licnce taken earlier for the same export
product.
Decision : Committee considered case as per agenda ura una i, tr,e prer"nce oitt";;;iirir"l-;rp..6;-1ffi;l
:decided to rati0/ the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm,
iwhichever is lower:
:
,,*,-.....''''-''''" . -.......'1
ICase No.:71/17/82-ALC4/2016 1ParサName:GLOBAL ёALё luM IMも
`iヽ
。/b五18:jた,」 :Statiζ :~ |
| _ _ :TTTツ:F::' 世鰍鰍f lppЮК
d l
ぽ
Q田∝
mおν“υ
m“ 2ハm7鶴ち鵬OЮ“ぉハШα l悧鼎α囲∝
"紗31 1
per
IT3M輛
i蔑札am:議
濡`瓦
縮め雨▼Ai姓
漱
普
魏ダ‐
吾常喩
撫I
o5.06.2018 :
|■脱鳳11話;…
~競蕊
::∴:I話1 1常策ま面雌仇‐
3諸温ふ
:
170 1Kll:1:11::1■:11 11lLlll l‐: : ちl i‐ :-1-~~1 1 ■ 1 :1 1 1 1 ‐ ‐ ‐ ―｀ ― ―‐―‐
23
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed in kg
CALCIUM GLUCONATE―
INJECTABLE
l kg
1
GLUCONO DELTA
LACTONE
1.09 kg
う
４
CALCIUM
CARBONATE
0.30 kg
172
Item of Export
Quantity
S.No.
Item of Import
Quantity
allowed per
million vials
DTP― HEPB―HIB FULLY
LIQUID VACCINE,
SINGLE DOSE(0.5ML)
VIAL,PEDIATRIC
DOSE DIPHTHERIA,
TETANUS PERTUSSIS,
HEPATITIS B
RECOMBINANT AND
HAEMOPHILUS
INFLUENZA TYPE B
(HIB)COMBINED
VACCINE WITH
VACCINE VIAL
MONITOR(VVM)
Vials
1
POLYETHYLENE GLYCOL
6000(MACROGOL)
76.848 kg
2.
AEROSlL 380V(COLLIDAL
ANH SILICA BP)
20.375 kg
GLYCEROL
122.84 1 ltr.
4
TⅦEN-20(POLYSORBATE
20)
7.685 1tr.
POTASSIUM THYOCYNATE
169.742 gms
6.
TRIS BUFFER
10.216 kg
7
ALUMINIUM CHLORIDE 6
HYDRATE EXTRA
27.665 kg
YEAST EXTRACT
22.447 kg
9
DEXTROSE(GLUCOSE)
35.937 kg
10
L―CYSTINE
0.437 kg
BACTO CASAMINO ACID
31.758 kg
う
乙
THIOMERSOL
0.379 kg
SILICON EMULS10N
16.5 kg
14
ADIPIC DlHYDRAZIDE
(ADH)
1.686 kg
N-3-
DIMETHYLAMINOPROPYL―
N―ETHYLCARBODIMIDE
HCL(EDC)
167 545 gm
16
2-oヽ―MORPHOLINO)
ETHANE SULFONIC ACID
(MES)
1.441 kg
17
CETAVLON
1537 gm
ALUMINIUM PHOSPHATE
GEL 2%(ADJU.PHOS 2%)
76.991 kg
19
L―TYROSINE
0.7841 kg
20
NZ CASE TT(CASEIN
PEPTONE PLUS)
39.12 kg
21
VITAMIN BI HCL
1.14 gm
IRA may take appropriate action as per the decision
lCase No.:126/r0t82-ALC4/2016 llg
Nurn"'BIOLOGICAL E
:Mcet No/Date:3/82-
IALC4/2018
105.06.2018
lApproved
:HQ File:01/82/050/00472/AM17/1RLA File
. 1:09/24/040/00306/AM15/
:Lic.No/Date:0910063657 :
:19.05.2016 :
: Committee considered case as per agenda and In the light of earlier decision taken by NC in its I l/82
lmeeting 24.01 .2018, it was decided to ratify norms under Para 4.7 of HBP v I as per details given below or as
tapplied by the firm, whichever is less:
24
(THIAMINE
HYDROCHLORIDE)
22
GLASS VIALS
100000 nos
う
４
RUBBER STOPPERS
095638 nos
24
ALUMINIUM CAPS/SEALS
088334 nos
う
Ｚ
HEATMARKER VACCINE
VIAL MONITOR(VVM
LABELS)
1086508 nos
26
SHIPPING INDICATORS(Q
TAG 2 PLUS)
902 nos
27
FILTERS&FILTER AIDS
250 nos.
―
:
，
′
Item of Export
Quantity
S.No.
Item of Imporl
Quantity allowed
per million vials
DTP―HEPB― HIB
(PENTAVALENT
VACCINE)FULLY
LIQUID
COMBINAT10N
VACCINE,10 DOSE(5
ML)VIAL,PEDIATRIC
DOSE DIPHTHERIA,
TETANUS PERTUSSIS,
HEPATITIS B
RECOMBINANT AND
HAEⅣ10PHILUS
INFLUENZA TYPE B
(HIB)COMBINED
VACCINE WITH
VACCINE VIAL
MONITOR(VVM)
vial
1
POLYETHYLENE GLYCOL
6000(MACROGOL)
768.48 kg
2.
AEROSIL 380 V(COLLIDAL
ANH SILICA)
203.75 kg
GLYCEROL
1228.4 1ltr
4.
TWEEN-20
(POLYSORBATE)
76.58 1tr.
POTASSIUM THYOCYNATE
1697.42 gms
6.
TRIS BUFFER
102.16 kg
7
ALUMINIUM CHLORIDE 6
HYDRATE EXTRA
276.65 kg
YEAST EXTRACT
224.47 kg
9
DEXTROSE(GLUCOSE)
359.37 kg
10
L―CYSTINE
4.37聰
11
THIOMERSOL
3.79 kg
つ
４
ADIPIC DIHYDRAZIDE
`ADHヽ
16 86 kg
N-3-
DIMETHYLAMINOPROPYL―
N ETHYLCARBODIMIDE
HCL(EDC)
1675.45 gm
14
SILICON EMULSION
165.00 kg
2‐(N‐MORPHOLINO)
ETHANE SULFONIC ACID
(MES)
14.41 kg
16
CETAVLON
15.369 kg
17
ALUMINIUM PHOSPHATE
GEL 2%
769。91 kg
iCase No.:83/11/82‐ALC4/2016
:P征りName:BIOLOGiCAL E
:LTD
:Meet No/Datei3/82-
IALC4/2018
105.06.2018
Status:
Approved
IHQ File:01/82/050/00617/AM17/1RLA File
ILic No/Date:0910063658
119.05.2016
lDecision : Committee considered case as per agenda and In the light of earlier decision taken by NC in its I l/82
,meeting 24.01 .2018, it was decided to ratify norms under Para4.1 of HBP vl as per details given below or as
;applied by the firm, whichever is less:
25
―
|
IRA may take appropriate action as per the decision of Norms Committee.
:
:∵
面
0/82‐ALd血
lml出
温
:翻
F滋
獅
源
~
| IHQ File:01/82/050/00448/AM17/IRLA File lLic.No/Datc:0510398628 :
| | :05/23/040/00091/AM17/ 126.052016 1
175
IDecision: Committee considered case as per agenda and and in the presence of the technical experts, it
idecided to ratify the ad-hoc input output norms under para4.7 of HBP as per details below or as applied by
lwhichever is lower:
IRA may take appropriate action as per the decision of Norms Committee
:ided to ratify the ad-hoc input ou
ichever is lower:
tput norms under para 4.7 of HBP as per details below or as applied
Export product
Exp.
Sl.No.
Import items
Qty. Allowed in kg
一
―
|:ζき｀ま
liiシibたがALё4/2biとい1●Na轟も
|IRESЁ｀
1むS kAЁ i~IMもtiヽ8′b品ijなう: ‐
も
ilttζ
l :NCOLOGY
ЫM「ED I諸
″ 盤f Fpproved l
l。品面加価赫面ブ膨魏:鳳島
I話ち ,党策
&面0398話■ 1
1Decision:Committee considered case as per agenda and and in the presence of thc technical experts,
■was
L‐TYROSINE
7.81 kg
19
NZ CASE TT(CASEIN
PEPTONE PLUS)
391.2 kg
20
VITABIN BI HCL
(THIAMINE
HYDROCHLORIDE)
11.45 gm
21
GLASS VIALS SILCONISED
5ML
1100000 nos
つ
４
つ
４
RUBBER STOPPERS
1085430 nos
23
ALUMINIUM CAPS/SEALS
1076890 nos
24
HEATMARKER VACCINE
VIAL MONITOR LABELS
(VVM LABELS)
1100000 nos
25
SHIPPING INDICATORS
(OTAG 2 PLUS)
1790 nos
26
FILTERS&FILTER AIDS
2500 nos.
27
BACTO CASAMINO ACID
317.58 kg
62/0¨ PLATIFYLLINE
HRDROTARTRATIS 2 mg
(LIQUID INJECT10N)
PLATIPHYLINE
HYDROTARTARIC
1100.00 gm
76
by firm
iCase No.:134/7/82-ALC4ノ2016 ParりName:ORBIT LIFE
l lSCIENCE PVT LTD.
:Meet No/Date:3/82-
:ALC4/2018
:05.06.2018
iStatus:Deffered I
rand Re-indexed
.74 r-rQ nir.
1 101/82/050/00308/AM17/
IRLA File
:03/95/040/00069/AM17/
ILic No/Date:0310804944
12405.2016
IDefer l
lDate:0506.20181
rDecision : Deferred for comments of TE
―
|
26
「胃… 駒面
IParりName:ALPHAMED
FORMULAT10NS P LTD.
Mcct No/Datci3/82-
:ALC4/2018
105.06.2018
―
l
Approved
)
|
| |
甲硫
覇濡蕊鳥1薦再
ILic.No/Date:0910063771
108.06.2016
experts, it was
r aoolied bv firm
77
Qty.
Levobupivacaine Hydrochloride
l kg
1
S‐ 2,6‐Pipecoloxylidide
Assay:NLT 98%
0.945 kg
may take appropriate action as Pe the decision of Norms Committee
necision : Committee considered case as per agenda and and in the presence of the techntcal experts, lt
decided to ratiff the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by
whichever is lower:
Export product
Exp.
Qty.
Sl.No.
Import items
Qty.Allowed in
mgんablet
GURONSAN C
EFFERVESCENT TABLETS
Number
1
D-Glucuronolactone
51.00
０
４
Ascorbic Acid
(CryStanine)
306.0
3
Sodium Polyphosphate
50.0
4
Sodium Hydrogen
Carbonate
950.0
GinFizz Micron Flavour
30.0
6
Monosodium Fumarate
2000.00
7
Sodium Sacchirin
30.0
Printed Tube for
Guronsan C Eff Tabs
Relevant as per
packing policy
may take approPriate action as Pe the decision of Norms Committee
IDecislon:Deferred for comments of TE
「
179
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed in kg
Amisulpride
l kg
1
4-Amino-5 - Ethyl
Sulphonyl )- 2- MethoxY
Benzoic Acid
Raw material
0.892kg
Mcet No/Date:3/82‐
IALC4/2018
105.06.2018
Status:Deffered
,and Re-indexed ,
,RA
F8諄。Ⅲ
e
|:01/82/050/00467/AM17/
IRLA File
i:09/24/040/00032/AM17/
Lic.No/Date:0910063765 1Defer
108.06.2016 ‐Date:05.06.2018
IMcet No/Datci3/82-
IALC4/2018
105.06.2018
,Status:
Approved
LABORATORIES PRIVATE
.LIMITED
IHQ File:01/82/050/00497/AM17/IRLA File
109/24/040/00123/AM17/
ILic.No/Date:0910063778 :
109.06.2016 1
（
―
27
:RA may take appropriate action as perthe decision ofNorms Committee l
Case No。:61/11/82-ALC4/2016
Party Name:KEKULE PHARMA
Deffered
Re-indexed
LTD
: Committee considered the case as per agenda it was decided to call from the firm complete
details as per appendix 4E.
IRLA File
:09/24/040/00017/AM17/
:蹴鼎α剛∞“知
B脂ち
5Юa矧8:
28
iCase No.:12/10/82‐ ALC4/2016 ParりNamc:CAPLIN POINT
l lLABORATORIES LTD.,
IHQ Filざibf/8夕bζb/obbζ慧/AMiウ′|にLA File
IMcct No/Datc:3/82- Status:
:紺″鰍f Fpproved
iLic.No/Date:0410162034 1
110.06.2016 :
104/24/040/00043/AM17/
Decision : Committee considered case as per agenda and and in the presence of the technical .*p.,tr. it was
decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm
;whichever is lower:
Export product
Exp.Qty.
Import items
Qty. Allowed
Lincomycin Hydrochloride
lnjection USP 600 m! 2ml
179104.000
vials
Lincomycin Hydrochloride
USP
110.105 BOU
ICase No.:14/10/82-ALC4/2016
1
Paty Name:CAPLIN POINT ,Icet No/Date:3/82-
LABORATORIES LTD., IALC4/2018
105.06.2018
Status:
,Approved
.
;;p..t;, it ;;;.
applied by firm'
HQ File:01/82/050/00360/AM17/IRLA File
104/24/040/00049/AM17/
lu""iti"n--i Cor.nitt.. .or;id;J "";,
us f"i-ug.naa and and
ldecided to ratifu the ad-hoc input output norms under para 4.7
lwhichever is lower:
i
,Case No.:25/10/82-ALC4/2016 Party Name:ASTEC
I ILIFESCIENCES LTD.,
IHQ File:01/82/050/00371/AM17/IRLA File
1 103/94/040/00132/AM17/
:Lic.No/Date:0410162041
114.06.2016
in the presence of the technical
of HBP as per details below or as
'Mcet No/Datei3/82-
:ALC4/2018
105.06.2018
:Lic.No/Date:0310805494
115.06.2016
,Status:
'Approved
０
０
;Decision : Committee considered case as per agenda and and in the presence of the technical experts, it was l
ldecided to ratifi the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm,
;whichever is lower no repeat one time basis only:
Export product
Exp.
Qty.
Sl.No
Import items
Qty. Allowed in kg
DEXTRINOL
l kg
1
CROTONIC ACID
0.849 kg
つ
４
BUTADIENE
0.629 kg
; The above norms is allowed for one time basis and no repeat licence allowed
;RA may take appropriate action as per the decision of Norms Committee
|
Export product
Exp. Qty.
Import items
Qty. Allowed
Nystatin Oral Suspension BP
1000001U/ml(30 mlBo■le)
86878.000
Number
Nystatin BP Micronised
265 85 BOU
iCase No.:23/10/82‐ALC4/2016 Paty Name:RECKITT
:
‐BENCKISER(INDIA)
| IPRIVATE LIMITED,
Meet No/Datei3/82-
ALC4/2018
05.062018
'Status:Deffered
,and Re-indexed
,84
iHQ File
l:01/82/050/00369/AM17/
,RLA FiIC
:05/24/040/00128/AM17/
Lic.No/Date:0510398826 1Defer
16.06.2016
:Date:05.06.2018
29
Decision : Committee considered the case as per agenda it was decided to call from the firm Master Batch
lFormula (MBF).
l
Case No。:29/10/82-ALC4/2016 ParりName:AARTI Meet No/Date:3/82¨
iParty Name:AARTI
ALC4/2018
05062018
IINDUSTRIES LIMITED
陣Q ΠL Ю1/82/050/00375/AM17/EARb~~~ ~卜
に.No/Dttα 0310805623
| ::03/94/040/00208/AM17/ 121.06.2016
|も:嘉iζ~~:|
:Approved i
l :
Decision : Committee considered case as per agenda and and
ldecided to ratify the ad-hoc input output norms under para 4.7
,whichever is lower no repeat one time basis only:
in the presence of the technical
of HBP as per details below or as
experts, it was
applied by firm
185
Export product
Exp
Qty.
Sl.No.
Import items
Qty. Allowed in kg
3,4,5 TRIFLUORO BROMO
BENZENE
l kg
1
2,3,4 TRI FLUORO
ANILINE
0.86 kg
2
SODIUM
HYPOPHOSPHITE
0.23 kg
take appropriate action as per the decision of N,orms Committee
may
approprl
Export product
Exp.
Qty
Sl.No.
Import items
Qty. Allowed in kg
5¨DIFLUOROMETHOXY―
2MERCAPTO-lH‐
BENZIMIDAZOLE
l kg
1
ACETONITRIL
0.17
2
CHLOROFORM
0.18
3
SODA ASH
3.03
4
PARACETMOL
1.435
5
CARBON DISULFIDE
0.70
6
FuUON GAS
0.715
per
一藤
ICase No.:33/16/82-ALC4/2016 1Party NameiSHREE JAYA IMeet No/Date:3/82- Status: |
ILABORATORIES PVT LTD. :ALC4/2018 1Approved l
05.06.2018
| :LTD.
獅 面広M17/紆こr
::lD′ Z争′υttυ /υ υυυソ/AIV■l′ / 1ZZ.υ
。・Zυ 10 1 1
17器服:ぶ撃滝Ъ襴ⅧTttullttξ悧i請L″∬ふTTttll:講
n諄
l:s琳籠
:bl淵
|
IWhiChever is 10wer:
|
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed in kg
ALPHA LIPOIC ACID
l kg
1
ALPHA LIPOIC ACID
0.909 kg
一
‐ PHARMACEU■
CALS PV■
■LC例
8
計
p「側di
tT TD 105 06,01R
臨:蕊蕊I~~シ繊》
5100482951~丁
:
IRA
‐86
IHQ File:01/82/050/00850/AM17/:RLA File
ILic.No/Date:0910063810
121.06.2016
Decision : Committee considered case as per agenda and and in the presence of the technical experts, it was
,decided to ratifu the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm
lwhichever is lower no repeat one time basis only:
,
30
GRANULES 90%
USP
つ
４
HYDROXY
PROPY/METHYL
CELLULOSE E¨ 5
0.080 kg
SILICON D1 0XIDE
0.002 kg
## Case No.:35/16/82¨ ALC4/2016
ヽ
1
「QⅢ釧加
50/00“2ハ田
7
,Decision : Committee considered
decided to ratifu the ad-hoc input
,whichever is lower:
|
Party Name:SHREE JAYA
'Meet No/Date:3/82‐
:ALC4/2018
105.06.2018
LABORATORIES PVT LTD.
Status:
Approved
RLA File lLic.No/Date:0910063814 1
1:09/24/040/00154/AM17/ 122.06.2016 1
case as per agenda and and in the presence of the technical experts, it was
output norms under para 4.7 of HBP as per details below or as applied by firm
lRA may take appropriate action as per the decision of Norms Committee
:
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed in kg
3‐DIMETHYL AMINO-1‐
PROPYL CHLORIDE
HYDROCHLORIDE
l kg
1
卜BROM0 3-CHLORO
PROPANE
1.005
2
TOLUENE
0.675
3
DIMETHYLAMINE
2.00
ParけName:DSM SINOCHEM
PHARMACEUTICALSINDIA
IPVToLTD.
1濶
納‐ ‐
Status:Deffered
,and Re…lndexed
i
89 1HQ Flle RLA File Lic No/Date:22100155H IDefer
101/82/050/00455/AM17/ 122/24/040/00022/AM17/ 123.06.2016 1Date:05.062018
Decision : Committee considered the case as per agenda and it
Consumption data and call the firm for personal hearing.
was decided to call from the firm Production
ICase No.:5/11/82-ALC4/2016 1Pa“ y Name:ASCENT Meet No/Date:3/82¨
IFINECHEM PVT LTD., IALC4/2018
0506.2018
IHQ File:01/82/050/00539/AM17/IRLA File tic.No/Date:0810138218 1 1
1:08/24/040/00104/AM17/ 128.06.2016 1 :
Decision : Committee considered case as per agenda and and in the presence of the technical expefts, it was
by nmi
|
Decision : Committee considered case as per agenda and and in the presence of the technical experts,
decided to ratiff the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied
whichever is lower no repeat one time basis only:
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed in kg
RASPBERRY KETONE/4-(4-
HYDROXYPHYENYL)
BUTANE‐ 2-ONE WHITE
CRYSTALLINE POWDER
l kg
1
p―HYDROXY
BENZALDEHYDE
(LIGHT YELLOW
CRYSTALLINE
POWDER),PARA
HYDROXY
BENZALDEHYDE,4-
HYDROXY
BENZALDEHYDE
1.69 kg
,Status:
Approved
90
31
may
appropriate
per
2
ACETONE
(COLORLESS LIQUID)
0.802 kg
G2PAC ASSEMBLY 700
LITER/250 KGS(35
lnch x 35 inch x 35 inch
polyprpelene woven
fabric bags)
Relevant as per
packing policy
RA mav take appropriate action as per the decision of Norms Committee
ICase No.:92/16/82¨ALC4/2016 1Pa●y Name:HETERO LABS
:LIMITED
IHQ Filc:01/82/050/00909/AM17/IRLA File
i09/24/040/00157/AM17/
,Approved I
i
ILic.No/Date:0910063873
130.06.2016
hichever is lower:
Export product
Exp.
Qty.
SIoNo.
Import items
Qty. Allowed in kg
MARAVIROC
l kg
1
NORTROPINONE HCL
5.27
つ
４
HYDROXYLAMINE
HCL
3.60
TETRA HYDROFURAN
1777
4
SODIUM METAL
481
5
ACETIC HYDRAZIDE
2.78
6
BENZALDEHYDE
7.70
7
MALONIC ACID
7.58
8
L(+)TARTARIC ACID
3.73
9
DI TERT.BUTYL DI
CARBONATE
2.84
10
VITRIDE
8.40
SODIUM
TRIACETOXY BORO
HYDRIDE
2.24
う
ん
4,4-DIFLUORO
CYCLOHEXANE
CARBOXYLIC ACID
0.59
Decision : Committee considered case as per agenda and
and in the presence of the technical experts, it
4.7 of HBP as per details below or as applied by
decided to ratify the ad-hoc input output norms under para
、vasl
Arm
91
rca面正面而蔑[瓦c″η
“
濤響
NarttASEN雨
LABξ
|l :
1胃面繭而画面瑶珈蕊源扁
……
「
~1
10う | _ _
´ _ _
―~~~~~
‐
―
´‐‐――――
o,)'- Decision : Committee considered case as per agenda and and in the presence of the technical experts, it was ,
decided to ratit/ the ad-hoc input output norms as applied by the firm under para 4.7 of HBP for one time basis and I
,
;ro repeat licence is allowed.
:
|IIII農1:1二ila“。
n tt p∝me d∝ぉ
bn OfNαШ
s Conlm燎∝ |
193 iCaseNo.:7/11/82-ALC4/2016
:Paty Name:PANERA B19TEC Meet No/Date:3/82¨
IStatus: :
IMeet No/Date:3/82-
:ALC4/2018
105.06.2018
Status:
Approved
IMeet No/Datei3/82-
:ALC4/2018
105.06.2018
32
:94
iDecision : Committee considered case as per agenda and in the presence of the technical expirts, it ;6 d|"id;a b l
iratif' the ad-hoc input output norms as applied by the firm under para 4.7 of HBp for one time basis
"rO ," .*"
licence is allowed.
Export product
Exp.
Qty
Sl.No.
Import items
Qty. Allowed in kg
IMIPENEM AND CILASTATIN
SODIUM(1:1)FOR INJECTION
l kg
1
Bicyclic Ketoester
1.526
2
Cysteamine
Hydrochloride
0.56
3
DiphenylChloro
Phosphate
1.297
4
4-Dimethyl Amino
Pyridine
0.015
N-Methyl-2 -Pyrrolidone
2.070
6
S‐ (十)-2,2-
Dimethylcyc10propane
Carboxamlde
0.450
7
Dowex TM
0.020
Carbon Enoanticromos
(Activated Carbon)
0.200
9
Ethyl 7-chloro-2-
oxoheptanoate (or)
Alpha-Keto Ester
0.80
0
Acetone
15.50
1
Acetonihile
6.05
2
Isopropyl Alcohol
0.80
Methanol(Methyl
AlcohOl)
12.00
14
Methylene Chloride
20.00
N- Hexane
3.79
16
Tetrahydrohan
2.75
17
Toluene
6.71
Aluminium Canisters
with Inner & Outer Lids
(with eaquel Plugs /
Caps)
Relevant as per
paking policy
RA may take apprOpriate ac10n as perthe decisiOn ofNorms Commhee
File:01/82/050/00541/AM17/:RLA File Lic No/Date:0510398951‐
|~ ~ |
33
Decision : In the light of earlier decition taken by NC in its meeting 0l/82 dated 01.05.2018.
rati$/ the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by
lower:
ICase No.:2/16/82-ALC4/2016 Paty Name:ASTRAL
ISTERITECH PVT.LTD.
|:01/82/050/00819/AM17/
|:34/24/040/00100/AM17/
lDecision : In the light of earlier decision taken by NC in its meeting 0l/82 dated 01.05.2018,
lratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by
llower:
it was decided to
firm whichever is r
it was decided to
firm whichever is
lT而面4/2016~[孵鵬
甲面
1/82/6而00587AM雨稀翻淋議
:蔦
1 . :υ
D/ソ■/υ ttυ ′υυZDD/AlVl1// IUD.U′
.ZU10
97 1Decislon:Committee considered case as per written comments of D/o Pharmaceuticals vide DOP O.M Nol
,35011140612016-Pl (Norms ) dated 17 .10.2017 and it was decided to ratifu the norms under para 4.7 of HBP as per
.
rdetails below or as applied by firm whichever is lower:
Export Product
Qty.
Ｓ
‐
Ｎ
。
Import Item
Qty a110Wed in
gm
Amylmetacresol Antiseptic Throat Lozenges
1000
1
Amylmetacresol
0.612 gm
―
―
塵
CEFEPIME FOR
INJECT10N lGM
STERILE
CEFEPlME FOR
INJECTION
CEFEPIME FOR
INJECTION lGM
STERILE
CEFEPIME FOR
INJECT10N
1.8975 gm/vial
:Meet No/Date:3/82- IStatus:Deffered
l紺″盤ピ
iandRc‐
hdexed
iLic.No/Date:3410042325 1Dcfer
,05.07.2016 1Date:05.06.2018
ICase No.:5/14/82‐ ALC4/2016
鶉
I馬器D.
難き棚Tcン
82
105.06.2018
HQ File:01/82/050/00803/AM17/IRLA File
134/24/040/00099/AM17/
ILic.No/Date:3410042324
10507.2016
95
Export product
Exo. Otv.
Sl.No.
lmport items
Qty. allowed
Number
1.8975 gm/vial
2.
GLASS
BOTTELS
Relevant as per
nackins nolicv
RUBBER
STOPERS
Relevant as per
oackins oolicv
|
,RA concerned may take further necessary action as per above decision of NC
IHQ File
|
Export product
Exp. Oty.
Sl.No.
Imoort items
Otv. allowed
Number
2.
GLASS
BOTTELS
Relevant as per
oackins oolicv
R∪BBER
STOPERS
Relevant as per
nackinp nolicv
34
Sugar Free Blackcurrant and Other
Flavor.Each Lozenges contains
Amylmetacresol 0.6 MG, Isomalt ST-M
2533.567 MG. Net Content Amylmetacresol
0.99 Kes, Isomalt ST-M 4195.75 Kgs.
Number
2
Isomalt St-M
2507 gm
Amylmetacresol Antiseptic Throat Lozenges
Sugar Free Blackcurrant and Other
Flavor.Each Lozenges contains
Amylmetacresol 0.6 MG, Isomalt ST-M
2533.567 MG. Net Content Amylmetacresol
0.99 Kes, Isomalt ST-M 4195.75 Kes.
1000
Number
1
Amylmetacresol
0.612 gm
IRA may take appropriate action as per the decision of Norms Committee.
lёistNよ:3′ i3'82-ALCI′ibi`‐ PaOヽ1■まξuN
I IPHARMACEUTiCAL
I ,INDUSTRIES LTD。,
|10F・iiどibiた,/o3b/o6`ji,AMi力
RLA li3~‐ ‐
IMeet No/Date:3/82‐ :Status:
IALC4/2018 ,Approved
105.06.2018 1
1Lic.No/Date:0510399022 1
98 Dtttお1:こ6拓島貴
18886Aまとも
:さaあζ
3:ζ pe:ぬざ古
da tta h the presence ofthe technicJ expe■s,■was decded to
,ati″ the ad― hoc input output norms as applied by the nrm under para 4.7 of HBP for one time basis and no repeat
llicence is allo、ved
l lRA may take appropriate ac」on as perthe decision ofNorms Commtttee
ciζ:N」:42'11/82‐ Atё4/2bi` ''各もヽ嘉
A`:AARTi
l INDUSTRIES LIMITED
IQFiお
揃た
'ん
蒟んあウ
`広
M″
漱協
'j:ふ
1話;
IMcctNo/Datei3/82‐ iStatus:
‐ALC4/2018 :Approved
105.06.2018 1
1Lic.No/Date:0310806121 1
112.07.2016 1
:
199
1
:
Decision : Committee considered case as per agenda and and in the presence of the technical experts. it was
ldecided to rati0/ the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm
;whichever is lower:
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed in kg
(S,S,S)-2‐
AZABICYCLO[3.3.0]OCTANE―
3¨CARBOXYLIC ACID
BENZYL ESTER
HYDROCHLORIDE
l kg
1
L―SERINE
150
2
BENZYL ALCOHOL
2.128
3
50/OPALLADIUM ON
CARBON CATALYST
0.050
| IRA may take appropriate action as per the decision ofNorms Committee i
l lCase No。:10/14/82‐ALC4/2016 ParりName:GLOBAL Mcet No/Date:3/82- IStatus: |
1 1
ン
E〕CNES LTD, 1紺
鰍鰍f ,ppr°
Ved .
| IHQ File 101/82/050/00808/AM17/IRLA File Lic.No/Date:3410042344 ‐ |
: | |:34/24/040/00101/AM17/ 112.07.2016 1 1
1100"ι tもi品:ёもhtti品8もも
Iζ籠8ied biζ も
iζ
``i亀
8ha五五五a:Aa h ii``亮:8品8 61ti8:ももhntふも長
“
薇:1喜:ζ
l
l deCided to rati～
the ad― hoc mput Output noms under para 4.7 of HBP as per detaib bdow or as apphed by ttrm i
1 lwhichcvcr is lowcri l
Export product
Exp. Qty.
SI.No.
Import items
Qty. Allowed
,
35
Glycine (200 Mesh)
Net Content per I MT: Glycine
(Granular 30-80 Mesh) I MT
88.000 MT
1
Glycine (Granular 30-80
Mesh)
88.88 MT
ICase No。:103/16/82¨ ALC4/2016 ParりNamc:AUROBINDO
IPHARMA LIヽ41TED
Status:
jApproved
|
experts,
applied
一
ｗ
ａ
ｓ
飾
一
ｉ
ｔ
ｂ
ｙ
101
appropnate
per
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed in kg
LACOSAMIDE
l kg
1
BOC― D―Serinc
2.277
つ
４
Monoethylene Glycol
DimethylEther
(Monoelvme)
600
Carbon Enoanticromos
(Activated Carbon)
00355
4
Mcthylene Chloridc
29.86
Toluene
308
6
Iso Propyl Acetate
7.17
take
actlon as
Case No。:10/11/82‐ALC4/2016
| |
| |
P2駆児
5叩∞御蔦下~
IRLA Filc lLic.No/Date:0310806238
1:03/95/040/00304/AM17/ 114.07.2016
,Mcet No/Datei3/82-
SiatusrDeffered
and Re-indexed
;Defer
:Date:05.06.2018
,
IALC4/2018
105.06.2018
Decision : Committee considered the case as per agenda and it was decided to call from
technical details as per appendix 4E
|
IDate:05.06.20181
the rlrm completel
## Case No.:32/16/82‐ ALC4/2016 ParりName:AUROBI｀bё IM8etヽ3/bitも:j/恵
'_ ~~lζ
iatit:‐ |
IPHARMA LIMITED IALC4/2018 1Approved
‐
,05.06.2018 1
1HQFileЮ
lだ2Ю50Ю084ワAM171‰
ち刷iυ0021VAM17 1糟
ざ%Rl°
0910063947 1 1
1Decision:Committee considered casc as per agenda and and in the presence of thc technical experts, it wasi
decided to ratitt the ad―
hoc input output norms under para 4.7 of HBP as per details below or as applied by arm l
whichever is lower:
Qty. Allowed in kg
3-{3-(4‐ Fluorophenyl)―
1(卜methylethyl)-lH¨
Fluvastatin Sodium
IHQ File:01/82/050/00920/AM17/1RLA File
:09/24/040/00174/AM17/
iMcet No/Date:3/82-
lALC4/2018
105.06.2018
ILic No/Date:0910063926
114.07.2016
RA
＾
υ
Export product
呻
韓
SI No.
Import items
l kg
1.3938
2
Diethylmethoxyborane (
50Yowlw. in THF)
0.5903
n-Heptane
1.06
36
4
Activated Carbon
(Carbon Enoacticromos)
0.0076
Acetone
0.027
6
Methanol(Methyl
Alcohol)
3.15
7
Tetrahydromran(THF)
5.80
Toluene
104
may take appropriate action as per the decision of N,orms Committee
Ｆ
Ｉ
Ｉ
“
―
―
ICase No。:27/16/82‐ ALC4/2016 ParりName:BRILLIANT BIO ,Meet No/Date:3/82- Status:
‐
I PHARMA PRIVATE LIMITED IALC4/2018 1Approved
l l :05.06.2018
ザ
Q ΠL Ю1/82/050/00844/AM17/‰
ち刷,0/00132/Aヽ
・
に°No/DtteЮ910063967 1 1
117/ 121.07.2016 1 1
109/24/040/00132/AM17/ 121.07.2016
1)ecision :Committee considered case as per agenda and in the presence ofthe technical experts, it、
vas decided l
10 ratitt the ad_hoc input output norms as applied by the illll under para 4.7 of HBP for one」
me baJs and nol
tlo ratlry me aO-nOC lnput Output norms aS app[eo 0y tne llrTn unoer para 4.1 OI H.By IOr One tlme basls anO nO]
lrepeat licence is allowed.
,
iRR may take appropriate action as per the decision of Norms Committee
l iCase No.:83ノ13/82-ALC4/2016
: |
PTサName:REANNON
PHARMACEUTICALS
| ICase No.:20/13/82¨ ALC4/2016 ParりName:FuSENIUS KABI MeetNo/Date:3/82- Status:Approved‐
10NCOLOGY LIMITED IALC4/2018
. 105.06.2018
′ 105.06.2018
1鶴島児
5υ∞“
VA剛7 琺ち鵬OЮ囲鳳m7 1鼎鼎α剛∞
"節21 1
1 11シ
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,0/00211/AM17/ 1タ
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381亀もAふi andlthe品ちAも8♂品
お
`温
面
8支b:こi嚇畠品籠8a
1 1:ぶ
lよ:tT寓
∬
t°
・
p頭nα Шs器の山dby me nm und∝ptta 47 of HBP br one dme basis and no
1 lRAmaytakeappropriateactionasperthedecisionofNormsCommittee
:Mcet No/Date:3/82-
:ALC4/2018
105.06.2018
lStatus: Approved l
1ltl
t:
IHQ File
l:01/82/050/00711/AM17/
RLA File
103/95/040/00327/AM17/
Lた.No/Date:0310806482
121.07.2016
1105もき
ttぉ11
case as per agenda and in the presence of the technical experts, it was decided
ito rati8/ the ad-hoc input output norrns as applied by the firm under para 4.7 of HBP for one time basis and no
irepeat licence is allowed.
i
:
iRA may take appropriate action as per the decision of Norms Commiffee
IParty Name:OPTRIX
:LABORATORIES PRIVATE
:LIMITED
:Mcet No/Datei3/82-
:ALC4/2018
:05.06.2018
Status:
Approved
|
Ю71QⅢ
∝∝慇ν
“
υ∞"7A剛7
:Lic.No/Date:0910063977
:25.07.2016
lDecision : Committee considered case as per agenda and and in the presence of the technical experts, it was
ldecided to ratifu the ad-hoc input output norms under paru4.7 of HBP as per details below or as applied by firm
,whichever is lower:
IRLA File
l:09/24/040/00235/AM17/
37
Export product
Exp.
Qty.
Sl.No.
Import items
Qty.Allowed
in gm
VELPATASVIR
Gram
1
(2S,4S)-tert-butyl 2-(5 -(2-((2S,5 S)- I -(S)-2-
((methoxycarbonyl)amino)-3 -methylbutanoyl)-5 -
methylpyrrolidin-2-yl)- l, I I -
dihydroisochromeno [4,3 : 6,7]naphtho [ 1,2-
dlimidazol-9-yl)- I H-imidazol-2- yl)-4-
(methoxymethyl)pynolidine-
1 -carboxylate)
1.56
2
(2R)- [(methoxycarbonyl)amino] (phenyl)ethanoic
acid
0.50
HQ File
:01/82/050/00611/AM17/
:Lic.No/Date:0510399240 ヽ
:27072016 1
the presence of the technical experts, it was
HBP as per details below or as applied by flrm
Decision : Committee considered case as per agenda and and in the presence of the technical experts,
decided to ratify the ad-hoc input output norms under para4.7 of HBP as per details below or as applied
whichever is lower:
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed in kg
Amoxicillin Trihydrate
l kg
1
6-Amino penicillanic
acid(6-APA)
0.568
2
D-(-)-para-hydroxy
phenyl glycine base(p-
HPG base)
0.4687
3
Immobilized amidase
(HIT‐ABC)
0.0019
「
|
Case No。:78/11/82¨ALC4/2016
IHQ File RLA File
i:01/82/050/00612/AM17/ 1:05/23/040/00123/AM17/
:Decision:Committee considered case as per agenda alld
Par57 Name:ASIATIC DRUGS
I&PHARMACEUTICALS PVT.
:LTD.
'Mcet No/Date:3/82-
:ALC4/2018
:05.06.2018
iStatus:Approved
i
:L`｀も
/D品うζ
103j"jダ■… …… :
,ソ:設1919_____r__… …二_・I
and in the presence of the technicd expers,it wasi
4.7 of HBP as per det」L bebw or as apphed by irlni
109
:ided to ratifli the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied
ichever is lower:
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed in kg
Amoxicillin Trihydrate
l kg
1
6-Amino penicillanic
acid(6-APA)
0.596
2
D-(-)-para-hydroxy
phenyl glycine base(p-
HPG base)
0.417
Immobilized amidase
(HIT―ABC)
0.0027
1110,Case No.:79/11/82‐ ALC4/2016 1PatyName:ASIATIC DRUGS
..........."-:
,Status: Approved ,
t:1)
t:
iStatus:Approved i
38
「
~~~~~~下
謡FttW両面而驚惚需
師7~~~~~面
而直~~~~1守
だ哩,α 05Ю3992421 1
101/82/050/00613/AM17/ 1:05/23/040/00119/AM17/ 127.07.2016
1Decision:Committee considered case as per agenda and and in the presence of the technに
al expeis, l was
decided to ratitt the ad―
hoc input output norms under para 4.7 of HBP as per details below or as applied by nrm
lwhichever is lower:
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed in kg
Cephalexin monohydrate
l kg
1
7‐ Amino desacetoxy
cephalosporanic acid(7-
ADCA)
0.6586
つ
４
D-(-)-Alpha phenyl
slycine base(PG base)
0.522
3
Immobilized alllidase
(HIT―ABC)
0.0036
ハ
| ~~|
,猥
Mtt1/82-ALC4/獅6辞
鵬
18:出器
:¥零l麟
∫
“
般¨
iぼ
¨
「
側dl
l :LTD.
1責OFil` ~~~ ~ RLA lil` ~‐
Lic.No/Date:0510399241 ‐ |
101/82/050/00614/AM17/ 1:05/23/040/00125/AM17/ 127.072016 1
:Decision:Committee considered case as per agenda and and in the presence of the technical experts,
■wasl
: IDecision:Committee considered case as per agenda and and in the presence of the technical experts,
■wasl
l idecded to rattt the ad― hoc input output norlns under ptta 4.7 of HBP as per det」
ヽbdow or as apメおdby nmi
l Ⅲ
hChev∝ぉ
bw∝ :
1111:
Export product
Exp
Qty.
SI.No.
Import items
Qty. Allowed in kg
Cefadroxil monohydrate
l kg
l
7-Amino desacetoxy
cephalosporanic acid (7-ADCA)
0.643
う
ん
D-(-)-para-hydroxy phenyl
slycine base(p-HPG base)
0.5402
3
Immobilized amidasc(HIT―
ABC)
0.0048
ICase No.:64/13/82‐ ALC4/2016 1Party Name:AARTI
1lNDUSTRIES LIMITED
IHQ File:01/82/050/00692/AM17/RLA File
i ::03/94/040/00177/AM17/
to..irion : Committee considered
'decided to rati$ the ad-hoc input
twhichever is lower:
IMcet No/Datei3/82-
'ALC4/2018
105.06.2018
:Lic.No/Date:0310806697 1
128.07.2016 1
Status:
Approved
|
卜
2
case as per agenda and and in the presence of the technical experts, it was
output norms under para 4.7 of HBP as per details below or as applied by firm
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed in kg
(S,S)-2,8-
DIAZABICYCLO
NONANE
l kg
1
PYRIDINE-2-3
DICARBOXYLIC ACID/2,3-
PYRIDINEDICARBOXYLIC
ACID
3.31
39
つ
４
BENZYL AMINE
2.21
D―TARTARIC ACID
1.00
4
SODIUM BOROHYDRIDE
POWDER
0.414
1,2‐DIMETHOXYETHANE/
MONOGLYME
1.50
tRA may take appropriate action as per the decision of Norms Committee
「
一
|
ICase No.:85/16/82‐ ALC4/2016 Party Name:OPTRIX ,Mcet No/Datei3/82- IStatus: |
I LABORATORIES PRIVATE IALC4/2018 1Approved l
l lLlMITED 05.06.2018
‐ 1
1HQ File lRLA File Lic.No/Date:0910063995 1 1
101/82/050/00902/AM17/ 109/24/040/00234/AM17/ 128.07.2016 1 1
‐ ‐‐一 ‐ ´ | ―- 1
1 Decision:Committee considered case as per agenda and and in the presence of the technical experts, I was
decided to ratifo the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm
whichever is lower:
Export product
Exp.
Qty.
Sl.No
Import items
Qty. Allowed in
gm/gm
Grazoprevir
Gram
1
(laR,5S,8S,10R,22aR)-5-(1,1-
Dimethylethyl)¨
1,la,3,4,5,6,9,10,18,19,20,21,22,22a―
tetradecahydro-14¨ mcthoxy… 3,6-dioxo-8H―
7,10‐
methanocyclopropa[18,19][1,10,3,6]dioxadi
azacyclononadecino[11,12-b]quinOxaline-8-
carboxvlic acid methvl ester
1.45
う
４
( I R 2S)- 1 -Amino-N-(cyclopropylsulfonyl)-
2-ethenylcyclopropanecarboxamide-4-
methyl benzenesulfonate
OR I -Amino-N-(Cyclopropylsulfonyl)-2-
ethenyl-( I R 2S)-Cyclopropanecarboxamide
4-methylbenzenesulphonate(1
: I )
1.26
‐ lCase No.:31/16/82-ALC4/2016
1 1
IHQFib:01/82/050/00848/AM17/
|
ParけName:OPTRIX IMeet No/Date:3/82- iStatus:
ILABORATORIES PRIVATE 'ALC4/2018 1Approved
lLIMITED 105.06.2018 1
IRLA File
:09/24/040/00236/AM17/
江
itiヽも
'5itも
:o9ib6`jう99~‐「
~
29.07.2016 :
it was
by firm
|
|
1114
Decision : Committee considered case as per agenda and and in the presence of the technical experts,
decided to ratif the ad-hoc input output norms under para4.7 of HBP as per details below or as applied
whichever is lower:
Export
product
Exp.
Qty.
Sl.No.
Import items
Qty.
Allowed in
gm/gm
Elbasvir
Gram
1
(6S)-3, 1 0-Dibromo-6-phenyl-6H-indolo[ 1,2-
clI l,3lbenzoxazine
OR (S)-3, I 0-dibromo-6-phenyl-6H-
benzo[5,6] [ l,3loxazino[3,4-al-indole
1.00
2
tert― butyI(2S)-2-(5-bromo-lH― imidazol‐ 2-
yl)pyrr01idine― 卜carboxylate
OR(S卜tert―butv1 2-(5¨bromo-lH― imidazol‐2‐
1.00
40
（
・
ｔ
F“
赫
Й /82-ALa加
押
濡
麒雨&歯
漱i薯
鮮
品
1濡
ユ
|
「
QⅢ∝mttν∞υ∞
“
3ハM18/難
λttυ ∞引νAM 7 :淵
鼎
醐
ЮЮ
“"| |
IDecision:Committee considered casc as pcr agcnda and and in the presence of the technical experts, it was
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed in kg
Rosuvastatin Tertiary Octyl Amine
Salt.
( Rosuvastatin TOA).
l kg
1
N -(4-(4-Flurophenyl)-5 -
Formyl-6-
Isopropylpyrimidin-2-yl)-N-
Methylmethanesul fonam ide
0mdCHO) (Z-8).
1.013
2
(D― Methy1 3-((te■―
butyldimethylsilyl)oXy)-5-
oxo…6-(triphenyl
Phosphoranylidene)heXanOte
(J-6).
1.543
Diethylmethoxyborane (4 M
solution in THF) DEMB.
0.346
RA may take appropriate action as per the decision of Norms Commiftee
１
１
１
週
「iCaseN F・鰤認臨…
1顆
:3/82‐ …
1
1%鶏
屋λ::1蕊講I詰″
…
…
:RLA ttF~~~‐
~~~燕
、ぁ
品如
面
'お
b
`:34/24/040/00133/AM17/ 104.08.2016
| :Case No.:21/16/82‐ ALC4/2016 ParりName:ARENE LIFE IMcet No/Datei3/82- IStatus:
| : ISCIENCES LIMITED. :ALC4/201
8 Approved
,05.06.2018 1
IHQ File:01/82/050/00838/AM17/1RLA File
1 109/24/040/00151/AM17/
1 lDecおlon:DeFerred for comments of TE
ILic No/Date:0910064013 1
108.08.2016 1
Decision : Committee considered case as per agenda and and in the presence of the technical experts,
decided to ratiff the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied
whichever is lower:
Export product
Exp.
Qty
Sl.No
lmport items
Qty.
Allowed
in kg
1-(AMINO
METHYL)CYCLOHEXANE
ACETIC ACID
HYDROCHLORIDE
l kg
1
1,1-CYCLOHEXANE DIACETIC
ACID MONOAMIDE
0.988
may take appropriate action as per the decision of Norms Committee
it was i
by firm r
卜
7
IStatus:Deffered I
:and Re― indexed l
IDefcr
iDate:05.06.2018
IRA
41
ICase No.:78/13/82‐ALC4/2016 1PatyName:AARTI
IINDUSTRIES LIMITED
ALC4/2018
05.06.2018
Fa Fit; ot/82l0i0/00?06/AMrz mu.ffil;-
,i
1:03/9410401003711AM17/
Decision : Committee considered .ur. u, per agenda and and in the presence of the technical
ldecided to ratifi the ad-hoc input output norms under para4.7 of HBP as per details below or as
,whichever is lower:
|
,Status:
'Approved
|
|
‐
experts, it was
applied by firm
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed in kg
(S,S)‐ 2,8‐
DIAZABICYCLO
NONANE
l kg
1
PYRIDINE‐ 2-3
DICARBOXYLIC ACID/2,3-
PYRIDINEDICARBOXYLIC
ACID
3.31
2
BENZYL AMINE
2.21
D¨TARTARIC ACID
100
4
SODIUM BOROHYDRIDE
POWDER
0.414
1,2-DIMETHOXYETHANE/
MONOGLYME
1.50
HQ File 101/82/050/OH51/AM17/IRLA File
:09/24/040/00223/AM17/
ICase No.:190/17/82‐ ALC4/2016 1ParりName:GLAND PHARMA
ILIMITED
IMcet No/Datei3/82- IStatus: |
1諸″ 鰍f ,pproVed
‐
ILic.No/Date:0910064041 1 1
116.08.2016 1 1
presence of the technical experts, it、vasl
・
11111
Decision : Commiffee considered ca
decided to rati8/ the ad-hoc input ou1
whichever is lower:
se as per agenda and and in the presence of the technical experts, it
Put norms under para 4.7 of HBP as per details below or as applied by
Export product
Exp.
Qty.
SI No.
Import items
Qty. Allowed
Voriconazole powder for Injection
200mg/vial,3Oml Vial
USP
Number
1
Voriconazole
USP
210 mglvial
う
′
Klcptose
NF
3200mglvial
Vials
Glass
Relevant as per
packing policy
4
Rubber Stoppers
Rubber
Seals
Plastic
6
Filters
Plastic
Consumption not
allowed under
policy
7
Tubing
Plastic
‐ ICase No。:40/13/82-ALC4/2016
ー
|
:120
|
119
:ALC4/2018
105,06.2018
:Approved
42
;RA concerned may take further necessary action as per above decision of NC
Export Product
Qty.
SI.No.
Import items
Quantity
allowed in ke
Delta-Valerolactone
l kg
1
1,5-Pentanediol
1.486
iHQ Fiお ~ ~ =LA「
16
… … ticヽ
も/D読
`:ζ
うibb4うoo3 1 ~ |
::01/82/050/00668/AM17/ 1:52/24/040/00036/AM17/ 119.08.2016 1 :
:Dedsbn:Committee consdered case as per agenda and delberatcd on thc ma■
er in the presence ofthc technicd l
lcxperts and it was decided to ratifV the ad‐
hoc inout outDut nOrrns under nara 4 7 of HRP as ner rletnilヽ
heinw nr,ql
:
iexperts and it was decided to ratifu the ad-hoc input ouput norms under para 4.7 of HBP as per details below or as
]applied by firm whichever is lower :
l
|:01/82/050/00647/AM17/
|:05/23/040/00234/AM17/
119.08.2016
irei
,Case No.:15/16/82-ALC4/2016 1ParりName:GRANULESINDIA
: :LIMITED
1 1
iHQ File:01/82/050/00832/AM17/:RLA File ,Lic.No/Datc:0910064057 1
1:09/24/040/00264/AM17/ ■9.08.2016
| |:09/24/040/00264/AM17/ 119.08.2016 .
‐
lDecision:Committee considered case as per agenda and and in the presence ofthe technical expens, it wasl
ldeCided to ratitt the ad¨ hOC input output norms under para 4.7 ofHBP as per details below or as applied by irm l
,whichever is lower: |
,Mcet No/Date:3/82-
:ALC4/2018
105.06.2018
―
一
ichever is lower:
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed
in kg
TENOFOVIR DISOPROXIL
SUCCINATE
l kg
1
(R)-9-(2-Phosphonyl Methoxy
propyl) adenine
0.769
う
４
Chloromethyl Isopropyl
Carbonate
1.3527
1輩面3/82‐AL繭ご
1123H。「i18 ‐~~~
| ::01/82/050/00778/AM17/
RLA Filc
:05/24/040/00201/AM17/
| IDecおlon:Deferred for comments of TE
「
~摯
ιttiM3/82-ALё 4/20■~PaO Nam前
↑Ё良6 LA麓
1 1 1
1 1 :
1124「
0‐118bシ恵
″おも
ん
6レう
1広Miラ′島ぁぶ
“
j::」ユ
1↓∴
;
Status:
Approved
Decision : Committee considered case as per agenda and
^
:
|
ICase No.:19/13/82‐
lAI」
C4/2016
10NCOLOGY LIMITED
|
ParりName:FRESENIUS KABI Meet No/Date:3/82‐
IALC4/2018
105.06.2018
,Status: Deffered
;and Re-indexed
:121
:RLA File
:Defer
lI)ate:05.06.2018
Status:
,Approved
IMeet No/Date:3/82-
:ALC4/2018
,05.06.2018
lStatus:Deffered
,
land Re-indexed l
Lic.No/Date:0510399507 1Defer
19.08.2016 1Date:05.06.2018
IALC4/2018
105.06.2018
:Lic.No/Date:0910064084
101.092016
and in the presence of the technical experts, it was'
43
rdecided to ratifu the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm
lwhichever is lower:
i
Export product
眸
叫
Sl.No.
Import items
Qty. Allowed
in kg
PALBOCICLIB
l kg
1
6-Bromo-2-chloro-8-cyclopentyl-5 -
methyl pvrido[2.3-dlpyrimidin-7(8H)-one
1.54
2
Tert.butyl-4-(6-Aminopyridin-3 -
vl)oinerazine- I -carboxvlate
1.98
Vinyl butyl ether
0.85
RA
take
action as
the decision ofNorms Committee
may t2
## Case No.:164/13/82¨ ALC4/2016
appropnate i
per
125 Decision:Committeeconsideredthecaseasperagendaanditwasdecidedtocall
fromthefirmfollowing
information
i)
| ILIMITED
iHQ File lRLA File
:01/82/050/00792/AM17/ :09/24/040/00311/AM17/
requirement of all imported inputs
iD
Firm may be called for personal hearing to explain above
ALC4/2018 1and Re¨ indexed l
'05.06.2018 ‐ |
1「お策
揃
“ “
面
B壺1:蔦」
:|
l
All items applied for import do not match with the chemistry given and their use in the process of
,
manufacture is not clear. Firm may be advise to give item wise reactions and yields to justifuing the
農
## Case No.:168/13/82‐ ALC4/2016 Pa●y Name:HETERO LABS IMcet No/Date:3/82‐
Status:Deffered l
:LIMITED ALC4/2018 iandRe¨
indexed l
:LIMITED ALC4/2018 iandRe¨
indexedl
l 105.06.2018 ,
′
, ' ____=t __ | ___、
_… ___´
|
IHQ File RLA File Lic.No/Date:0910064085 1Defer l
:01/82/050/00796/AM17/ :09/24/040/00301/AM17/ 01.09.2016 1Date:05.06.20181
information
i)
ii)
:
All items applied for import do not match with the chemistry given and their use in the process of
:
manufacture is not clear. Firm may be advise to give item wise reactions and yields to justif,ing the ,
requirement of all imported inputs
Firm may be called for personal hearing to explain above
二
|
whichever is lower:
Export product
Exp.
Qty.
SI No
Import items
Qty.A1lowed in
kg
SACUBITRIL
l kg
1
(2R,4S)-4-Amino-5 -(b iphenyl- -yl)-
2-methylpentanoic acid ethyl ester
hydrochloride
1 174
126 Decision
## Case No.:170/13/82¨ ALC4/2016 Party Name:HETERO LABS
ILIMITED
Mcet No/Date:3/82-
:ALC4/2018
105.062018
,Status:
l
Approved l
HQ File:01/82/050/00798/AM17/
IRLA File
:09/24/040/00284/AM17/
I Lic.No/Datei0910064083
101.09.2016
44
ハ
|
ICase No.:196/17/82‐ ALC4/2016
Palty Name:ORCH
ILABORATORIESINDIA PVT
ILTD
IMeet No/Date:3/82-
IALC4/2018
105.06.2018
1Lic.No/Date:0910064089
,01.09.2016
;iQ nire ,o|Isiloloiotts,itavtnt lnra eii.
,
l:09l24lO40l00292lAMl7l
:RA may take appropriate action as per the decision of Norms Committee
Decision : Committee considered case as per agenda and and in the presence of the technical experts.
decided to ratiry the ad-hoc input output norms under para4.7 of HBP as per details below or as applied
whichever is lower:
Export product
Exp.
Qty.
Sl.No.
Import items
Qty.A1lowed
in kg
4-(Sulphamoyl Phenyl)
Hydrazine Hcl
l kg
1
Sullhnilamide
1.01
2
Methanol
0.65
1 1Case No.:109/13/82‐ ALC4/2016 1ParりName:AURA
‐ : IPHARMACEUTICALS PVT
｀ | :LTD
rHQ File :0118210501007371AM171 ,RLA Fite
i
:O3t94t040t004}4tAMt7t
IMcet No/Datei3/82¨
IALC4/2018
105.06.2018
Lic.No/Date:0310807613
:06.09.2016
Status:
Approved
t:
ilrl,]
rperts, it was :
f―
29
Decision : Committee considered "ur. u, per agenda and and in the presence of the technical experts. it
decided to ratiry the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by
whichever is lower:
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed in kg
LUAROL(ORS)SACHETS EACH
SACHET CONTAINS 13.5GM OF
DEXTROSE ANHYDROUS
(TOTAL NET WEIGHT OF
DEXTROSE ANHYDROUSIN
5,00,000 SACHETS ARE 6750.00
KGS)
500000
Number
1
DEXTROSE
ANHYDROUS BP
6817.5 kg
CETROL(ORS)SACHETS EACH
SACHET CONTAINS 13.5GM OF
DEXTROSE ANHYDROUS
(TOTAL NET WEIGHT OF
DEXTROSE ANHYDROUSIN
12,00,000 SACHETS ARE
16200.00 KGS)
1200000
Number
2
DEXTROSE
ANHYDROUS BP
16362 kg
RA may take appropriate action as per tlte decision of Norms Committee
」
1言
ι品化あ0/82‐ ALむあ硫
響mipL
薔
漱r恵
1濡
講11
11301責OFil`ibiた,/03o/Olt4夕AMiラ/RLA lile ‐ ~ ~~ Liき
:面。
/b表さ
ib4ib04う495 1 ~ |
| | |:34/24/040/00151/AM17/ lo7.09.2016 1 1
1 ■)orisinn : rnmmitt^ρ annOir10rOパ ハ。.0 0.^△.●^^^― ■^ ^― 月 ^_■ :_ 41^_ _____ _ 0 1 ■ ・ ● . |
| :Decおlon:COmmitee cOnsidercd case as per agenda and and in the presence of the technicd expens,l wasl
l ldeCided to ratittthe ad‐ hoc input Output norms under para 4.7 of HBP as per details below Or as applied by arm l
Status:
Approved
45
―
¨
|
Export product
Exp.
Qty.
Sl.No.
Import items
Qty.Allowed
in kg
Atorvastatin Calcium
l kg
1
(4R-Cis)-, 1 - I -Dimethylethy-
6-cyanomethyl-2,2-di methyl-
1.3-dioxane-4 acetate
0.708
2
4-Fluoro-alpha-(2-methyl- I
oxopropyl) gamma-oxo-N-
beta-diphenyl benzene
butanamide
0.994
Methanol
6.79
4
Acetone
1.59
RA may take appropriate action as per the decision of N orms Committee
| ,Case No.:167/20/82-ALC4/2016 1ParりName:REINE .Mcet No/Date:3/82- IStatus:
. ` ILIFESCIENCE IALC4/2018 1Approved
‐ | | 105^06_2018 1
| l p,062018 1
釧
「T:TTTttη∵I轟¨ ↓…聞鷲罰
10042496~IF……
J :_41____^^^_^^ ^r`l_^`^^■_:^_1 ^、′_^4ハ .+、■
,ぅo ЯO^,/4△月
Decision : Committee considered case as per agenda and in the presence of the technical expefts. it was decided
Ito ratifo the ad-hoc input output norrns as applied by the firm under para 4.7 of HBP for one time basis no repeatl
licence is allowed.
ll
|
| IRAmり
泳e ttpЮ pH江ea“ on tt p∝me deddOn OfNoms Commhee __…
…
…
……
一― J
つ
４
Export product
Exp.
Qty.
Sl.No.
Import items
Qty.Allowcd
in kg
CEFIXIME USP/BP/1P/EP
POWDER
l kg
1
7-Phenylacetamideo -3-
Chloromethyl
Cephalosporanic Acid Para
Methoxy Benzyl Ester
(GCLE)
1.50
2
TRIPHENYL PHOSPHINE
0.82
ACETONE
0.81
4
N,N DIMETHYL
FORMAMIDE(DMF)
274
Dichloromethanc
(METHYLENE CHLORIDE/
MDC)
3.40
6
TRIETHYLAMINE
0.2717
7
PHENOL
0.3808
METHANOL
4.21
9
ACTIVATED CARBON
0.05
iCase No.:100/16/82‐ ALC4/2016 ParりName:DHANUKA Mcet No/Date:3/82- Status: |
| ILABORATORIES LTD. IALC4/2018 1Approved l
.05.06.2018 1 1
1。
れb薇茄断66"ラA面ヴ
億
珈
iliお:'1~~・
｀6/Date構而蛎
`bl ~■
M17/ .08.092016 1 1
1Decision:Committce considered case as per agenda and and in the presence of the technical experts, it wasl
idecided to rati～
the ad―hoc input output norms under para 4.7 of HBP as per details below or as applied by f―
:whichever is loweri
l
ハ
‐
‐
Iwhichever is loweri
10
MICA ESTER
082
TETRA HYDROFURAN
(THF)
1.64
may take appropriate action as
46
ヘ
per
'Case No.:167/13/82-ALC4/2016
|
HQ File :01/8210
:01/82/050/00795/AM17/
:Party Name:HETERO LABS
ILIMITED
|
lkLA lilも‐
109/24/040/00300/AM17/
IMeet No/Date:3/82‐
:Status:
:ALC4/2018
105.06.2018
1Lic.No/Date:0910064112
108.09.2016
Approved
Decision : Committee considered c
decided to ratifu the ad-hoc input or
whichever is lower:
ase as per agenda and and in the presence of the technical expefts,
[put norms under para 4.7 of HBP as per details below or as applied
Export product
Exp.
Qty
Sl.No.
Import items
Qty.A1lowed
in kg
VORTIOXETINE
HYDROBROMIDE
100.000
kg
1
2,4-
DIMETHYLBENZETH10L
185.000 kg
The above norms is allowed for one time basis and no repeat licence is allowed
,, it *ui
I by firm
per
ICase No.:169/13/82‐ ALC4/2016 ,ParりName:HETERO LABS IMcet No/Datei3/82- lstatus: |
1
ギ
MπD I淵盤f l即ЮК
d l
「
Q Fi3 bi/82んぶレ0075ケ広Mi7 1RLA iお
… ‐‐
●し、675五18bう16b641ij l ~~■
| ::09/24/040/00302/AM17/ 108.092016 1 1
134
:Decision : Committee considered case as per agenda and and in the presence of the technical expefts, it was .
decided to ratifi the ad-hoc input output norms under para4.7 of HBP as per details below or as applied by firm
is lower.
Export product
Exp.
Qty.
Sl.No
Import items
Qty. Allowed
in kg
TAMOXIFEN CITRATE
l kg
1
alpha-f[-(2-
(dimethylamino)ethoxy)phenyll
beta-ethyl-alphaphenyl
phenethyl alcohol
1.382
2
1,2-Diphenyl-Butan- I -one
0.20
RA may take appropriate action as
the decision of Norms
|
per
Committee
reN∝
η 9/17/"■LCtt61搬
柵
胤
瑞
譜8NAL片
棚
Tc3/82-鶏
児ted
l 1 105.06.2018
‐
|口r、口:1。 ,n tt A「
:1_ ` ~
|
貯
5
,HQ File iRLA File Lic.No/Date:0910064103 1
101/82/050/O H70/AM17/ 1:o9つ4/040/00246/AM17/ :08.09.2016 1
"ecisittlk温
言ふ僣
“
'お
Isid`:もる磁
`Ъ
:ξ
~“
i礎ぉ
lai and hどi the i)resence of the technical experts, it
decided to ratifu the ad-hoc input output
whichever is lower.
norms under para 4.7 of HBp as per details below or as applied
Ｓ
‐
．
Ｎ
。
Export product
Exp.Qty.
Sl.No.
Import items
Qty. Allowed in kg
by
RA
47
1
AGROFLOR-200
(Florfenicol vet.Oral solution―
20%w/v)1 litre pack
Number
1
FLORFENICOL
200 gm/1 1itre
pack
つ
４
AGROFLOR-100
(Florfenicol vet.Oral solution―
10%w/v)l llre pack
Number
2
FLORFENICOL
100 gm /1 litre
pack
3
AGROTIL― L
(TilmiCOSin vet.Oral solution―
25%w/v)1 1lre pack
Number
TILMICOSIN
PHOSPHATE
283.74 gm/1 litre
pack
4
AGROTlL(WSP)
(TilmiCOSin vet.Oral powder―
20%w/v)l kg paCk
Number
4
TILMICOSIN
PHOSPHATE
222.54 gm /l kg
pack
LESSCOX-2.5
(T01trazur‖
vet.Oral solution―
2.5%w/v)1 litre pack
Number
TOLTRAZURIL
25 gm 11 litre pack
6
AGROCLAZ
Diclazuril vet.Oral solution-1
%W/V)l litre pack
Number
6
DICLAZURIL
l0 gm / 1 litre pack
7
AGROFLOR‐ 200
Florfbnicol vet.Oral solution―
20%w/v)500 ml pack
Number
7
FLORFENICOL
100 gm/500 1nl
pack
nt may take appropriate action as per the decision of Norms Committee
[
ICase No。:159/13/82‐ ALC4/2016 Party Name:SUN
:Meet No/Date:3/82-
:ALC4/2018
105.06.2018
Status:
Approved
Icase No。:15ソ/15/3Z‐ALし4/ZU10 1rarty l・laHlc:o∪lN
IPHARMACEUTICAL
IINDUSTRIES LTD.,
:kFが増■e:0510399649 :
HQ File:01/82/050/00787/AM17/IRLA File
105/24/040/00264/AM17/
|
08.09.2016
technical
ｗ
ａ
Ｓ
肺
ｉ
ｔ
ｙ
ｂ
1136
Decision : Committee considered case as per agenda and and in the presence of the technical experts,
decided to rati! the ad-hoc input output norms under para4.7 of HBP as per details below or as applied
whichever is lower:
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed
in kg
Dorzolamide and Timolol
Ophthalmic Solution, 2.lohw lv +
0.Sohwlv,5ml (TIMODOL
Sterile Eye Drops)
(LOFTEMIDE)
l kg
1
DORZOLAMIDE
HYDROCHLORIDE
1.731
つ
４
TIMOLOL MALEATE
As applied
|
48
|
IB7
|:
1 1‐
I^^・
^"′
:~‐
・
V~rr^Vr^^"‐
―
"―
…
V“
―
―
r―
^‐
‐ ^―
―
―
― =―
‐ ―
…
V^‐
ヽ―
‐
“ 「
I―
r~―
^一
―
―
―
_ _______ヽ
―
一
‐―
一
|
iCase No.:208/17/82‐ ALC4/2016 ParりName:SUVEN LIFE 'Mcet No/Date:3/82- Status: |
l SCIENCES LIMITED :ALC4/2018 1Approved l
1
105.062018 1
′
IHQ File:01/82/050/01169/AM17/IRLA File lLic No/Date:0910064101
1 109/24/040/00256/AM17/ 108.09.2016
Decision : Committee considered case as per agenda and and in the presence of the technical experts, it was
decided to ratiff the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied
whichever is lower.
Export product
Exp.
Qty.
Sl.No.
Import items
Qty.Allowed
in kg
2-(TETRAHYDRO-2H― PYRAN―
4YL)HYDRAZINE
CARBOXYLIC ACID TERT―
BUTYL ESTER
l kg
1
N―HEPTANE
0.34
2
TETRAHYDROPYRAN-4-
ONE
0.625
TERT¨BUTYL CARBAZATE
0.825
4
NOBLYST PH41-10%
PALLADlUM ON CARBON
(Drv Basis)
0.036
may take appropriate action as per the decision of Norms Committee
by firm
iCase No。:166/13/82‐ ALC4/2016 1Pa●y Name:HETERO LABS IMeet No/Date:3/82- Status: |
| ILIMITED IALC4/2018 1Approved l
l l 105.06.2018 1 1
1HQ File:01/82/050/00794/AM17/:RLA File lLic.No/Date:0910064123 1 1
' |:09/24/040/00314/AM17/ 109.092016 1
:Decision:Committee considered case as per agenda and and in the presence of the technical experts, it wasl
ldeCided to rati″
the ad‐hOc input output norms under para 4.7 of HBP as per details below or as applied by ttrm l
1138
whichever is lower:
Export product
Exp.
Qty.
SI.No.
Import items
Qty. Allowed
in kg
1-[4-(PYRIDINE-2-
YL)PHENYL]‐ 5(S)-2,5-
BIS[(TERT.BUTYLOXY―
CARBONYL)‐AMINO]-4(S)‐
HYDROXY‐ 6‐PHENYL-2-
AZAHEXANE
2000000
kg
1
4-FORMYL PHENYL
BORONIC ACID
1000.000 kg
2
(2R,3D― N‐(3-AMINO‐ 2-
HYDROXY-4-PHENYL
BUTYL)― N-lSOBUTYL-4‐
AMINO BENZENE
SULFONAMIDE
1580.000 kg
The above norms is allowed for one time basis and no repeat licence is allowed
RA mav take aonronriate acfion aq ner the deciqinn nf Nnrmc (-nmmirrap
appropriate action as per the decision of Norms Committee
I I)ecislo■
:It was decided to ca‖ fronn the rlrnl connplete technical details as per appendix 4E .
I CaSe品満13/82■ta加
`■
轟続品IA面bkjbゞ
‐
雄漱
浄
挽が
,驚
意
曲
|
| | :LIMITED
I"'3駆λふ∴j鳥島
~ふ
魔蕊ふ私話;1聴
藁
よ面0807艦
饉
1:蕊鳳
|
49
## Case No.:90/ 16182-ALC4l2Ol6 Party Name:MAHIMA LIFE
Meet No/Dat e:3182'
Status:Deffered
I
SCIENCES PVT.LTD.
:ALC4l20l8
and Re-indexed,
I I
I
ios.o6.2ol8
140 He pit.
RLA File
Lic.No/Date:o5to3ggi4g Defer
:
l:01l82l05OlOO9O7lAMl7l ':0512410401002291AM171 :16.09.2016
Date:05.06.2018
r
Decision : lt was decided to call the firm for PH for explain their case.
| ICase No.:94/16/82-ALC4/2016 Palty Name:MAHIMA LIFE IMeet No/Date:3/82‐ Status:Deffered l
SCIENCES PVT.LTD. IALC4/2018 and Re…
indexed‐
05'06'201 8
l4l He pil.
RLA File
Lic.No/Date:0510399750 Defer
:oitszto50/0091tlAM1Tl ::o5l24l040l0023olA171l7l 16.09.2016
lDate:O5.06.2018
. :Decision:It was decided to can the rlrm fOr PH for explain their case.
iCase No。:95/16/82‐ALC4/2016 ParりName:MAHIMA LIFE 'Meet No/Date:3/82‐ Status:Deffered
l lSCIENCES PVT.LTD. :ALC4/2018
●nd Re‐ indexed
105.06.2018 1
И
210品 ‐…Ⅲ面ぎ‐↓島‐襦需面99746B圭1鳥鳳
101/82/050/00912/AM17/ 1:05/24/040/00222/A
■ __
‐ ‐‐ ‐ ‐ ~ ‐ ~ ‐ ‐ ~~―――
lDecision : lt was decided to call the firm for PH for explain their case.
iCur" N, .:Sl/rcBZ-A,LC4l20t6 Parry Name:MAHIMA LIFE lMeet No/Date:3182- 'status:Deffered
sctLNCES pvr.LTD.
ALC4l2ot8
and Re-indexed
',
1
1 1
ls 06 2019
143"O riも一 ~~ ~~… ■RLA lhざ ~ ~tはヽ6わ品163ibjう0ウ
`'‐
0さユ: …
| 101/82/050/00914/AM17/ .:05/24/040/00261/AM17/ 116.09.2016 Date:05.06.2018
ICase No。:6/20/82‐ ALC4/2016 ParりNamelMAHIMA LIFE
: ISCIENCES PVT.LTD.
1
t lDecision:It was decided to call the rlrm fOr PH for explain their case.
||
Status:Deffered
,and Re-indexed
r
:Lic.No/Date:0510399744
116.09.2016
IDecision:lt was decided to callthe rlrm fOr PH for explain their case。
‐ l υCCISI011:■ι WaS uじにluしu Lυ しollし=iC■‖ 111■υ■ ■■■■Vi しAP■`
1144■Oni`… … … …IRLA rile ~~~
| |:01/82/050/01183/AM17/ .:05/24/040/00221/AM17/
IMcet No/Datei3/82-
IALC4/2018
105.062018
| ,Case No.:70/16/82‐ ALC4/2016
| |
I HQ File 101/82/050/00887/AM17/
lm謂配ざ翼ギ∬0 性き淵Tαν紗~ 鶏:鵠ed
l 105.062018 1
1RLA File lLic.No/Date:0510399777 1
1:05/23/040/00237/AM17/ 120.09.2016 1
Decision
ided
: Committee considered case as
: ratiff the ad-hoc input outPut r
per agenda and and in the presence of the technical experts, it was
orms under para4.7 of HBP as per details below or as applied by firm
to
input
is lower:
norms
Export product
Exp
Qty.
Sl.No.
Import items
Qty.Allowed
in kg
MIFEPRISTONE
l kg
1
ETHYLENE DELTENONE
1.48 kg
2
PROPYNE GAS
kg
1.61
@e
action as per the decision of Norms Committee
50
:72/16/82-ALC4/2016 Party Name:ASIATIC DRUGS IMcet No/Date:3/82‐
lstatus:Deffered l
l&PHARMACEUTICALS PVT.IALC4/2018 1and Re―
indexed l
lLTD. lo5.062018 1
146 uq pit.
RLA Fire
Lic.No/Date:05r0399gr6 Defer
:011821050100889/AM l7l
':05/23t040/002t4/AM17 t
122.09.2016
lOate:05.06.2018
ll
` 1
` 1
ニニ |
| .Case No。:56/17/82¨ ALC4/2016
甲
y面繭
面薇i而
IParりName:J.B.CHEMICALS&IMeet No/Date:3/82‐
IPHARMACEUTICALS ,ALC4/2018
1LIMITED lo5.062018
RLA File iLi
IKしA rHe lLlC.No/υ
ate:
103/94/040/00582/AM17/ 126.09.2016
ILic.No/Date:0310808049 1
126.09.2016 1
IDecision:Committee considered
case as per agenda and and in the presence ofthe technical experts, it wasl
:cided to ratiff the ad-hoc input output norms under para4.7 of HBP as per details below or as applied
hichever is lower:
Export Product
Qty.
Ｓ
‐
Ｎ
。
lmpoft Item
Qty allowed in
gm
Zecuf - N- Lozenges Flavour
Orange/Lemon/Mint. Each Uncoated
Lozenge Contains Amylocaine
Hydrochloride 0.5 mg,
Bacitracin Zinc (100 Unit) 1.67 mg,
Neomycin Base 2.5mg Eq.to Neomycin
Sulphate 4.17mg. Net Content Amylocaine
Hydrochloride 5 Kgs, Bacitracin Zinc Ep
16.70Kgs Neomycin Sulphate USP
4l.70Kgs.
1000
Number
1
Amylocaine
Hydrochloride
0.510
2
Bacitracin ZincEP
1.70
3
Neomycin Sulphate
USP
4.25
by flrln
| ICase No.:13/17/82‐ ALC4/2016 ParサName:GUJARAT
: ‐ 10RGANICS LIMITED
…
|
IHQ File:01/82/050/00974/AM17/1RLA File
:03/94/040/00585/AM17/
L in the presence of the technicai experts, ii *u,
of HBP as per details below or as applied by firm
|
Export product
Exp.
Qty.
Sl.No.
Import items
Qty.Allowed
in kg
PARA ANISIC ACID
l kg
1
Para Hydroxy Benzoic Acid
1 12 kg
may take appropriate action as
the decision
appropriate
per
of Norms Committee
:… Ⅲ
稀iji3/82-ALC4/2面,お
‐N誌責Ё↑ЁttδIÅiS
瞥漑
学
あた夕~‐
濡螢R漁::
, ILIMITED
ザ19既:鳥協議話,~嘉ち魔蕊∴
Li↓3 1覇藁よ
09100面奸墓籠:ふ:|
I)ecision:Committee cOnsidered the case as per agenda and itl″ as decided to can from the rlrnl foHowing
l information
Status:
Approved
147
IMeet No/Date:3/82-
ヽALC4/2018
105.06.2018
ILic.No/Date:0310808096
127.092016
Status:
Approved
51
All items applied for import do not match with the chemistry given and their use in the process of ,
| 11
「
F
manufacture is not clear. Firm may be advise to give item wise reactions and yields to justifuing the
;
requirement of all imported inputs
Firm may be called for personal hearing to explain above
ICase No.:114/13/82-ALC4/2016 Paty Name:HETERO LABS IMeet No/Date:3/82‐
Status:Deffered
I LlMITED IALC4/2018 and Re―
indexed
105.06.2018
1HQ File RLA File Lic.No/Datc:0910064192 1Defer
:01/82/050/00742/AM17/ :09/24/040/00341/AM17/ 12709.2016 1Date:05.06.2018
D
All items applied for import do not match with the chemistry given and their use in the process of
manufacture is not clear. Firm may be advise to give item wise reactions and yields to justifying the
requirement of all imported inputs
i
iD
Firm may be called for personal hearing to explain above
lepeat liCence is a1lowed.
lRA may take appropnate ac●
on as perthc decision ofNorlns Committec
‐ ICase No.:140/20/82¨ ALC4/2016 Pary Name:SRINI IMcet No/Date:3/82‐ Status:
‐ | IPHARMACEUTICALS IALC4/2018 1Approved l
lPRIVATE LIMITED 105.06.2018
‐
ILic.No/Date:0910064196 1
1 HQ File:01/82/050/01317/AM17/RLA File .
‐
‐ ‐ 109/24/040/00348/AM17/ 128.092016 ‐ |
| IDecision:Committee considered case as per agcnda and in the presence ofthe technical experts,it was decidedl
1521° rad″ the ad― hOC input output norms under para 4.7 of HBP as per details below or as applied by Arm whicheverl
I
lis lower:
tt:]
i :d';N,.,igiritrsz-iLcqrzori ,!a*i$U;,ilrnl?Ir',0' - iy;a,ffi":3t82- ,ifi'';".
05.06.201 8
153 HQ File:01/82/050/01155/AMl7/ RLA File
Lic.No/Date:0910064206
:0912410401003391AM171 29.09 '2016
:
Decision : Committee considered case as per agenda and in the presence of the technical experts, it was decided
Ｆ
Ｉ
Ｉ
Ｉ
‘
‐
R¨ (‐)-3‐(CARBAMOYLMETHYL)‐
5-METHYL HEXAN101C ACID
PREGABALIN
150 lDecision :
case as per agenda and it was decided to call from the firm following
linformation:
l iCase No。:109/16/82-ALC4/2016
1 1
Party Name:PANERA BIOTEC
IPVT.LTD.
:Mcet No/Date:3/82-
lALC4/2018
105.06.2018
Status:
Approved
1汗Q Ⅲe
IRLA File
105/24/040/00307/AM17/
:Lic.No/Date:0510399924
128.09.2016
151
Export product
町
じ
Sl.No.
Import items
Qty.Allowed in
kg
l kg
1605
action as per the decision
52
to ratify the ad-hoc input output norms under para4.7 of HBP as per details below or as applied by firm wh
is lower:
Export product
Exp.
Qty.
SI.No.
Import items
Qty. Allowed
in kg
N―BENZYL-3(S)― HYDROXY
PYRROLIDINE(BHP)
l kg
1
L―MALIC ACID
2.69
2
BENZYLAMINE
2.28
TETRAHYDRO FURAN
3.77
4
SODIUM BORO HYDRIDE
2.26
R‐MANDELIC ACID
1.60
RA may take appropriate action as
ichever
## Case No.:90/13ノ82-ALC4/2016
Paty Name:AMI ORGANICS
PVT LTD.
Mcet No/Date:3/82¨
ILic.No/Date:5210042032
M17/ 130.09.2016
Status:Deffered
iand Re‐ indexed
IDcfer
lDate:05.06.2018
l iCase No。:69ノ16/82‐ALC4/2016
Party Name:DHANUKA
ILABORATORIES LTD.
IMb81‐ ヽ6′bit`:j821 ~~~:statuζ : |
:ALC4/2018 1Approved l
105.062018 1 1
Lic.No/Date:0510399960 1 1
103.10.2016 1 1
1ce ofthe technical experts, it was decidedl
、十●:1●ス01^、.′ ^"ぅ。‐^^1:△月ス.,■__、.,■:^■^_^_.|
.HQ File:01/82/050/00886/AM17/IRLA File
105/23/040/00310/AM17/
Decision : Committee considered case as per agenda and in the presence olthe technical experts. it was r
to ratif, the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm wh
is lower:
Export product
Exp.
Qty.
Sl.No.
Import items
Qty.Allowed
in kg
7 AVNA
POWDER
l kg
1
7-Phenylacetamideo -3 -
Chloromethyl
Cephalosporanic Acid Para
Methoxy Benzyl Ester
(GCLE)
2.672
2
TRIPHENYL PHOSPHINE
1.26
3
n― BUTYL ACETATE
5.06
4
METHYLENE CHLORIDE(
MDC)
12.66
5
PHENOL
0.933
6
METHANOL
800
RA may t2.26ake appropriate action as per the decision orNorms committe"
……… … … …… ―
― …… … ……
瀞bttt′恵
,」
…
lstatiζ
‐
|
se No.:98/16/82‐ ALC4/2016 Party Name:INDO PHYTO IMeetト
ICHEMICALS PVT LTD IALC4/2018 ,Approved i
l i05.06.2018 1 1
竹∬鼎α∞Ю
4000121
|
Decislon:COnlmittee considcred case as per agenda and in the presence ofthe technical experts, it、
vas decided
154
IHQ File
:01/82/050/00718/AM17/
156 HQ
Πb:01/82/050/00915/AM17/1職
ち∫liO/00293/AM17/
53
|
Export product
Exp.
Qty
Sl.No.
lmport items
Qty.Allowed in
kg
Estrone
l kg
1
ADD
1.40 kg
may take appropriate action as per the decision of Norms Committee
」
曲1需認も6~監漱T“脇 1聯hed
lCase No.:200/17/82-ALC4/2016 1Pa
‐ lP・
105.062018 1 1
ンA File ltic.No/Date:0910064252 1 1
HQRに
劇慇ν
“
0/Ol%νAM爾
尽
し/2Ю
“
Ю∞12/AM7 06Ю
2m6 1 1
1 10` ___ __ _
ヽ
一―
, 1 __ __ __
嵩atter in the presence ofthe technに
di
lDeciζ i。1:ё6稀轟11もe consiaきたとし基もas per agenda and deliberated on the 14.7 ofHBP as per details below or asl
lexperts and it was decided to ratify the ad_hOc input output norllas under para
lapplied by arln whthever is lower
Export product
Exp.
Oty.
SI.No.
Import items
Qty.A1lowed in
mgたablet
AMOXYCILLIN AND
CLAVULANATE
POTASSIUM TABLETS
625 MG
Number
1
6-APA
332.44
2.
D(-)P-Hydroxy
Phenyl Glycine base
274.32
MethyI Aceto
Acetatc
208.83
4
Methanol
171.02
Triethylamine
16.97
6
Methylene Chloride
193.14
lsopropyl Alcohol
246.40
N―N―Dimethyl
Acetamidc
57.94
9
Pivaloyl Chloride
193.14
10
Clavulanate
Potassium +Avicel /
Potassium
Clavulanate with
Microcrystalline
Cellulose (l:l)
303.77
:
IRA concemcd may take負■her necessary action as per above dccおion ofNC
― ‐
―m
「
He pit.
IRLA f il"
Lic.No/Date:0310808312 ;Defer
,:01)82/050/0Og72lAM17l :031941040100617lAM17l 06.10.2016
Dal::05 092;018;
. :U1/6Z/UDU/UUソ
/Z/AIVl1// :υ
D/ソ4′ υ ttυ ′υ υ 01′
′A lVll′
′ lυ
V.lV・
4ViV I―
いしV・Vν ●VV●´ V^VI
1158 15ttiζ i`I:む
`品
品
iti`も
`61ζ
ia`F`a th`ιムζもょζ｀
おも
riL`nda and it was decided to call from the nrm f0110wing l
‐ linformation
Copy of DML for each export product
Master Batch Formula for each export product
NOC from Ministry of Environment Forest and Climate Change
|
Status:Deffered
and Re-indexed
＞
り
Ｄ
1157
lse,
,
,\Lg!t?gr!
rApproved
105.062018
IHQ File
IRLA File
:Lic.No/Datc:0310808433 1s
54
1:01/82/050/01010/AM17/ 1:03/94/040/00622/AM17/ 117.10.2016 1 1
部‖ξ辮‖∬臓i:鋼:結籠1胤悧Ъ
ttdttndmttematterhぬ
e「∝釦∝
J ttd∝m硼
t norlns under para 4.7 ofHBP as per details below or as
lapphed by im whtheverislower l
Export Product
Qty.
Sl.No.
Import items
Quantity
allowed
Ipratropium Bromide 20mcg and
Salbutamol Sulphate 100mcg lnhaler
(200MD)DUOLIN INHALER
(200MD)
Number
1
Ipratropium
Bromide
4.00 mg
う
´
63mcI AEROSOL
VALVES
Relevant as
per packing
policy
3
19ml
ALUMINIUM
CAN
4
0.58 mm OD
ACTUATORS
WITH DUST
COVERS/CAPS
5
Heptafluropropane
P227 Gas
2l.l2mg
Ipratropium Pressurised Inhalation
40mcg / lpravent 40mcg Inhaler
(200MD) Ipramar 40mcg Inhaler
!umber
1
Ipratropium
Bromide
8.00 mg
う
４
63mcI AEROSOL
VALVES
Relevant as per
packing policy
19ml
ALUMINIUM
CAN
4
0.58 mm OD
ACTUATORS
WITH DUST
COVERS/CAPS
Heptafluropropane
P227 Gas
2l.l2mg
Ipratropium Bromide 20mcg and
Salbutamol Sulphate 100mcg lnhaler
(200MD)DUOLIN INHALER
(200MD)
Number
1
Ipratropium
Bromide
4.00
つ
４
63mcl AEROSOL
VALVES
Relevant as per
packing policy
19ml
ALUMINIUM
CAN
4
0.58 mm OD
ACTUATORS
WITH DUST
COVERS/CAPS
5
Heptafluropropane
P227 Gas
21.10 mg
1
,-t
,
,
I
I
lPzzzcut
IRA concerned may take further necessary action as per auove aecision orNc
|
|
ICase No.:9/17/82‐ ALC4/2016
IMeet No/Date:3/82¨
IALC4/2018
105.06.2018
Status:
)
Approved
160
IHQ File:01/82/050/00970/AM17/IRLA File
103/94/040/00629/AM17/
Lic No/Date:0310808422
17.10.2016
Decision : Committee considered case as per agenda and deliberated on the matter in the presence of rhe technical
lexperts and it was decided to ratifu the ad-hoc input output norms under para 4.7 of HBp as per details below or as
applied by firm whichever is lower:
55
（
‐
‐
ミ
‐
‐
Export product
Exp.
Otv.
Sl.No.
Import items
Qty. Allowed in kg
TINOSORB
VIVITRIAZ S
l kg
1
TOLUENE
2.80
2.
ACTIVATED
CARBON
0.100
ETHYLENE DI
CHLORIDE
ｎ
ン
4
uSORCINOL
1.20
2-ETHYL HEXYL
BROMIDE
1.54
concerned may take further necessary action as per above decision ofNC
161
Export product
Exp.
Otv.
Sl.No.
Import items
Qty. Allowed in kg
4-(1, 1-Dimethylcthyl)-4-
Methoxy dibenzoyl methane
(AVIS)
l kg
1
PARA
TERTIATORY 4-
TERT―BUTYL
BENZOIC ACID
OR PARA
TERTIARY
BUTYL BENZOIC
ACID(PTBBA)
2.
ACETYL
ANISOLE
0.83
ACTIVATED
CARBON
0.025
4
SODAMIDE
0.44
METHANOL
2.00
6
TOLUENE
1.00
I ICase No.:107/1`/82-ALC4/2016 1PartyName:DALAS B10TECH
1 1 1LTD.
RLA File
:05/23/040/00474/AM16/
ILic.No/Date:0510400138
118.10.2016
162
declded
ichever
ALC4/2018
:05.06.2018
HQ File:01/82/050/00924/AM17/
Decision : Committee considered case as per agenda and in the presence of the technical experts, it was <
to ratifu the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm wh
is lower:
Export product
Exp.
Qty.
Sl.No.
Import items
Qty.Allowed
in kg
D(¨)P‐HYDROXY PHENYL
l kg
1
D C) Para Hydroxy Phenyl
Glycin Base
1.025
:ALC4/2018
,0506.2018
:RLA File lLic.No/Date:0310808508
::03/94/040/00648/AM17/ '18.10.2016
case as per agenda and deliberated on the matter in the presence
lexperts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as i
:LIMITED
No/Date:3/82-
||
― ―
―
―
―
―
―
―
―
―
―
- 1
56
GLYCINE METHYL ESTER
つ
４
Methanol
0.76
may take appropriate action as
the decision ofNorms Committee
pcr
Decision : Committee considered case as per agenda and in the presence of the technical experts, it was ,
to ratifo the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm wh
is lower:
Export product
Exp.
Qty.
Sl.No.
Import items
Qty.A1lowed
in kg
Ropinirole Hydrochloride
l kg
l
N―(2-Methyl-3-
Nitrophenethyl)― N―
Propylpropan-1-Amine
Hydrochloride
2.146
つ
４
Methanol
5.54
Toluene
9.81
4
Acetone
4.76
may take appropriate action as per the decision of Norms Committee
」
| ICase No.:54/16/82‐ ALC4ノ2016 ParりName:IND― SWIFT Meet No/Date:3/82¨ Status: |
1 1 lLABORATORIES LTD., IALC4/2018 :Approved l
. 105.06.2018 1 1
1 :
Lic.No/Date:2210015580 1 1
1810.2016 1 1
lce ofthe technical experts,it was decided l
ichever
164
## Case No.:134/20/82-ALC4/2016 Party Name:OPTIMUS DRUGS
‐Meet No/Date:3/82- status:
,PRIVATE LIMITED IALC4/2018 1Approved
105.06.2018 :
Lic.No/Date:0910064282 1
20.10.2016
Decision : Committee considered case as per agenda and in the presence of rhe technical experts, it was decided
Ito rati& the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever
is lower:
Export product
Exp.
Qty.
SI No.
Import items
Qty.Allowed
in kg
LEDIPASVIR IH
l kg
1
(6S)-6-[5-[7-[2-(lR,3S,4S)-2
AZABICYCLO[2.2.1]HEPT
3¨ YL-lH― BENZIMIDAZOL
6‐ YL]-9,
9¨DIFLUORO-9H―
FLUOuN‐2-YL]-lH―
IMIDAZOL… 2-YL]‐5-
AZASPIRO[2.4]HEPTANE
HYDROCHLORIDE(1:4)
1.08
つ
４
2-Methoxy carbonyl amino 3-
methyl―butyric acid(or)
MOC¨ L―VALINE
0.394
may take appropriate action as
Ｆ
Ｌ
Ｆ
Ｌ
per
HQ File i01/82/050/00871/AM17/RLA Filc
122/24/040/00065/AM17/
163
IHQ File:01/82/050/01311/AM17/IRLA File
109/24/040/00390/AM17/
RA
ICase No.:116/20/82-ALC4/2016 Parり
Name:OPTIMuS DRUGS
IPRIVATE LIMITED
lMeet No/Date:3/82-
lALC4/2018
105,06.2018
:Status:
Approved
:09/24/040/00398/AM17/
121.10.2016
IHQ File:01/82/050/01293/AM17/IRLA File
57
ICase No.:51/16/82‐ALC4/2016 ParりNamellND‐SWIFT IMeet No/Date:3/82‐ Status: |
| ILABORATORIES LTD., IALC4/2018 1Approved i
l
‐ 105.06.2018 1 1
ギ
Q Πb Юν8705υ0086VAM17ら
た創iOЮ0067AM17
簿
∬%認
C2210015583 1 1
ら就:OЮ0067AM17/ 1ズ |
Export product
Exp
Qty.
Sl.No.
Import items
Qty.Allowed
in kg
CINACALCET
HYDROCHLORIDE
l kg
1
N-[( I R)- 1 -naphthalen- I -ylethyl]-3 -
t3-
(trifl uoromethyl)phenyllpropanamide
(OR) (R)-N-(l -(Naphthalen- I -
yl)ethyl)-3-(3-
(trifl uoromethvl)phenv l)propanam ide
1.18
iRA may take appropriate action as per the decision of Norms Committee
Decision : Committee considered case as per agenda and and in the presence of the technical expefts, it was
decided to ratifu the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm
is lower no repeat one time basis only:
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed in kg
CLARITHROMYCIN GRANULES
42%(SUSPENS10N GRADE)
l kg
1
CLARITHROMYCIN
0.4242 kg
つ
４
CARBOPOL
0.30 kg
3
HPMC Phthalate
0.30 kg
4
ACETONE
2.00 kg
RA may take appropriate action as per
re decis ion of Norms Committee
」
ICase No.:125/20/82‐ ALC4/2016 ParりName:ARENE LIFE Meet No/Date:3/82- Status:
1 1SCIENCES LIMITED ALC4/2018 ‐Approved
05062018
Decision : Committee considered case as per agenda and in the presence of the technical experts, it was decided
rc, :to :atify
the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever
is lower:
Export product
Exp.
Qty
Sl.No
Import items
Qty.Allowed
in kg
VALGANCICLOVIR
HYDROCHLORIDE
l kg
1
CBZ-L-Valine Ganciclovir
1.735
take
ate action as
may
approprl
pcr
1 鐙霊腸ふ
1120/82‐
1168:
| IHQ File
l ::01/82/050/01308/AM17/
Decision:Commimee cOnsidered case as per agenda and in the presence ofthe technical expens,■
was decidedi
“
o rattt the ad¨ hOc input output norlns under para 4.7 ofHBP as per det」ゝbebw or as ap口おd by irln whthever
iis lower: |
,
I
IHQ File
IRLA File
ILic.No/Date:0910064309
126.10.2016
IPaty Name:ARENE LIFE
ISCIENCES LIMITED.
IMcet No/Date:3/82-
IALC4/2018
105.06.2018
Status:
Approved
IRLA File
i:09/24/040/00319/AM17/
ILic.No/Datei0910064308
126.10.2016
58
and it was decided to rati$ the ad-hoc input output norms under para 4.7 of HBP as per details below or as
ied by firm whichever is lower :
Export Product
Otv.
SI.No.
Import items
Ouantiw allowed
DARUNAVIR
lkg
1
(2S,3S)-1,2-EPOXY‐
(BOCAMINO)-4-
PHENYLBUTANE
1.40 kg
2
ISO BUTYL AMINE
0.854 kg
3
4-ACETAMIDO BENZENE
SULFONYL CHLORIDE
1.30 kg
4
Carbonic acid, 2,5-dioxo-l -
pyrrolidinyl [(3 R,3aS,6aR)-
hexahydrofuro[2,3 -b] furan-
3vll ester (Carbamate)
0.598 kg
Methvlenc I)ichloride
6.00 kg
Export Product
Qty.
Sl.No.
Import items
Quantity allowed
in ke
TRIPHENYL PHOSPHlNE
lkg
1
MONOCHLORO BENZENE
2.378
2
MAGNESIUM INGOT
0.905
TETRAHYDROFURAN
0.80
4
YELLOW PHOSPHOROUS
0.206
:
tRA concerned may take further necessary action as per above decision of NC
lη 瓢二
|:脇誠話, 脇鵬υ∞“ν
AⅢ 7 芳∬鼎α“ЮЮtt Deb l
lDate:05.06.2018 1
1 1、^^:_:^ぃ
。n^`^"..^Л
F^..^^…
… ^"`^^FT壼
| IDecislon:Deferred for comments of TE
I
| ICase No.:15/17/82‐ ALC4/2016 Par″ Name:HARMONY IMeet No/Date:3/82- Status:Deffered
lLIFESCIENCE PRIVATE IALC4/2018 1and Re¨ indexed ‐
ILIMITED 05.06.2018
IPa=y Namc:DHANUKA
:LABORATORIES LTD.
1 1Case No.:126/20/82‐ ALC4/2016 1Patt Name:EMMEblNAR IMeet No/Date:3/82- ,Status: |
| | 'PHARMA PRIVATE LIMITED IALC4/2018 ,Approved l
l 1 l
Ю5 06.2018 1 1
1 轟
3星児
50Ю 1303/AM17 :‰ち刷
iυ00376ハM17 1野だり品
1°0910064311 1 1
| ::υ 1/。∠/υ Dυ/υ l,υ 」/AIVl l′ / 1.υ ソ/Z争′υttυ ′υυO′ U′ AlVl l′ ′ IZυ・lυ・′υlυ l l
l D3ふζお
i fё6島品
ilもち
86hζa品と
t基
`五
ζュi agendiindとも
1もさ島
iもとも
h iAきh:18:ii thざお泥ζ品品6fthcおし
hniあi
l leXpeis and l was dedded to ratitt the ad_hoc input output norms under para 4 7 ofHBP as per details below or asl
l lapplたd by Яrm whicheverislower:
11701
1 1 1 ExportProduct l Qty.I Sl・No.I ImpOrtitems l Quantityallowed l l
1721CaseNo.:19/1`/82‐ ALC4/2016
,Meet No/Date:3/82- lstatus:
:
ALC4l20l8
Approved
ICase No.:152/20/82-ALC4/2016 Pa岬
ILTD
Meet No/Date:3/82‐
ALC4/2018
05.06.2018
IStatus:]Deffered
iand Re‐ indexed
169に
IRLA File
Lic No/Date:0910064300 1Defer
26 10 2016 1Date:05.06.2018
lDecision : Deferred for comments of Department of Biotechnology.
59
「
I F~
Ю
,062∝8 1 ~
|「
QⅢ錮1/82/050/008mm7臨
0勝卿7 1
Decision : Committee considered case as per agenda and deliberated on the matter in the presence of tne teitrnicat
experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as
applied by firm whichever is lower:
Export product
Exp.
Oty.
SI No.
lmport items
Qty. Allowed in
me/tablet
CEFIXIME METHYL
ESTER USP/BP/1P/EP
POWDER
Number
1
7-Phenylacetamideo
-3-Chloromethyl
Cephalosporanic
Acid Para Methoxy
Benzyl Ester
(GCLE)
1.4219
つ
４
TRIPHENYL
PHOSPHINE
0.7756
ACETONE
0806
4
N,N DIMETHYL
FORMAMIDE
(DMF)
2.736
5
Dichloromethane
(METHYLENE
CHLORIDE/MDC)
3.393
6
TRIETHYLAMINE
0.2668
7
PHENOL
0.3808
METHANOL
4.222
9
ACTIVATED
CARBON
0050
10
MICA ESTER
0.820
TETRA
HYDROFURAN
(THF)
1.644
| ICase No。:130/16/82‐ ALC4/2016
1 1HQ File iO1/82/050/00947/AM17/
Pa“y Name:10L CHEMICALS
,AND PHARMACEUTICALS
ILIMITED
‐RLA File
:30/24/040/00027/AM17/
Lic No/Date:3010103875
127.10.2016
Decision : Committee considered case as per agenda and in the presence of the technical experts, it was ,
to rati0/ the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm wh
is lower:
Export product
Exp.
Qty.
SI No.
Import items
Qty.A1lowed
in kg
3ALPHA 7 BETA
DIHYDROXY 5BETA
CHOLAN 24 01C
ACID(TECHNICAL GRADE)
l kg
1
CHOLIC ACID(
TECHNICAL GRADE)
1.705
may take appropriate action as per the decision of Norms Commiftee
decided
richever
―
一
蒟不孫雨両面雨瓦画面百所雨孫冠雨¨戸~~顧
蓼D亜彊III卜tttus II
,ALC4/2018
105.06.2018
RA
60
:HQ File:01/82/050/01056/AM17/
RLA File
:08/24/040/00268/AM17/
:諸謄鰍T FpproVed i
LiNo/D嘉もう
jlolb慧う
0「
|… ~~1
,8.10.2016 1 1
as decided
whichever
一
Ｄ
一
」
Ｔ
赫
獅
■
舞
…
Ｌ
汀
ICase No.:11/16/82¨ALC4/2016
|
IHQ Fii3 b1/8夕b3b/ooj'8/AM17′
:
IP冨サName:EMCURE
IPHARMACEUTICALS LTD.
RLA Filc
:31/83/040/00094/AM17/
IMcet No/Date:3/82¨
IALC4/2018
'05.06.2018
:濡漁11
1 ~
…
Ⅲ…
‐~ |
, '
嚇
品:拓0086388
:31.10.2016
Decision : Committee considered car
to rati$ the ad-hoc input output norn
is lower:
se as per agenda and in the presence ofthe technical experts, it was
ns under para 4.7 of HBP as per details below or as applied by firm wh
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed
in kg
SEVELAL〔ER
HYDROCHLORIDE
[RELEVANT BULK DRUG]
l kg
1
POLYALLYLAMINE PAA―
HCL-3L
「CHEMICALl
1.012
SEVELAMER CARBONATE
[RELEVANT BULK DRUG]
l kg
1
ALLYLAMINE HCL
SOLUTION(60%)
「CHEMICALl
1.69
decided
ichever
1
;Case No.:18/16/82 -ALC4/2016 ;Party Name:HONOUR LAB
:Meet No/Date,3182- Status:
ll
1'os.o6.2ol8:
176
雫
‖
`血
たシbζ″66慧お,AMi″
聴ら魔:鳳|:鳳#‐
lngttbib6`4輛
■
‐
| |
:Decision:Committee considered case as per agenda and deliberated on the matter in the presence ofthe technicali
leXperts and it was decided to ratl取
the ad― hoc input output norlns under para 4.7 ofHBP as per details below or asl
lapplied by flrln whichever is loweri l
Export product
Exp.
Otv.
Sl.No.
Import items
Qty. Allowed
in ke
Isopropyl ((S)-(Perfluorophenoxy)
(Phenoxy)Phosphoryl)-L-Alaninate
l kg
1
L-alanine
0.74
2.
Dimethvl forlnamide
1.20
Phenyl dichloro phosphate
0.931
4
Triethvl amine
0.80
Pentafluorophenol
0.77
6
Diisopropyl ether
1.50
7
Acetonitrile
1.50
concerned may take further necessary action as per above decision of NC
―
‘
‥
■
■
―
“
‘
“
，
１
●
１
１
１
１
■
“
‥
■
■
一
Decision : Committee considered case as per agenda and in the presence of the technical experts, it was
to ratii/ the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm wl
is lower:
Export product
Exp.
Qty.
Sl.No.
Import items
Qty.Allowed
in kg
MYCOPHENOLATE MOFETIL
l kg
1
GLYCINE
2.29
::
61
,ase No■15820/82-ALC4/2016 1attName:ENAL DRUGS PVT MeetNo/Dtte:3/82-
1 1LTD。, IALC4/2018
1 1 105.06.2018
IDecision:Committee considered case as per agenda and deliberated on the ma“er in the presence ofthe technicall
:eXperts and it was decided to ratitt the ad―
hOC input output norms under para 4 7 ofHBP as per details below or asl
177 applied by nrm whichever is lower:
Export Product
Qty.
Sl.No.
lmport items
Quantity allowed
In ke
2,3‐DIMETHYL-4-
NITROPYRIDINE―N-OXIDE
lkg
1
2,3,LUTIDINE
0.85
2
METHYLENE CHLORIDE
1.175
ISOPROPYL ALCOHOL
0.46
:HQ File
i:01/82/050/01335/AM17/
RLA File
:09/24/040/00411/AM17/
RLA File
:09/24/040/00410/AM17/
Lic.No/Date:0910064347
103.11.2016
lStatus:
Approved
tStatus:
l
lApproved l
Status:
,Approved
:RA concemed may take亀
“
her necessary actbn as per above decisbn ofNC
警
蔽七め磁ユLc4/2“び
:濡聴
よ討TAN Lぷ
槽
棚
r“
麓―
HQ File
:01/82/050/01327/AM17/
Lic.No/ηDate10910064338
03.11.2016
口、
||
|
lDecision : Committee considered case as per agenda and deliberated on the matter in the presence of the technical I
lexperts and it was decided to ratifu the ad-hoc input output norms under para 4.7 of HBP as per details below or as I
,applied by firm whichever is lower :
Export Product
Otv
SI No.
Import items
Ouantitv allowed
4-AMINO-2‐OX0
PYRIMIDINYL
OXATHIOLANE-2-
CARBOXYLIC ACID ISO
PROPYL
METHYL CYCLO HEXYL
ESTER(CYCLO HEXYL
ESTER)OR(CHE)OR
(CHE‐ lH)
０
わ
Ｌ
ヽ
1
GLYOXYLIC ACID-50%
0.743
2
2,5 DIHYDROXY l,4-
DITHlANE
0.325
3
CYTOSINE
0.428
4
HEXAMETHYL
DISILAZANE
0.698
DIMETHYL FORMAMIDE
0.26
6
TRJETHYL AMINE
0.67
7
METHYLENE CHLORIDE
1.56
L¨MENTHOL
0.751
9
TOLUENE
1.00
RA concerned may take further necessary action as per above decision ofNC
'Case No.:157/20/82-ALC4/201` IPalty Name:HETERO LABS IMeet No/Date:3/82-
1 1LIMlTED IALC4/2018
‐05.06.2018
IHQ File
101/82/050/01334/AM17/
IRLA File
l:09/24/040/00426/AM17/
Lic.No/Date:0910064346
0311.2016
IDecision i Committee considered case as per agenda and deliberated on the mattcr in thc presencc ofthe tcchnicall
179静xpens and l was decded to rati″
the ad― hOc mput Outp面noms under ptta 4.7 ofHBP as per detttk bdow or asi
lapplied by nrm whicheveris lower i
Export Product
Otv.
SI No.
Import items
Ouantity allowed
Oseltamivir Phosphate
lkg
1
Shikilnic acid
1.66
2
Triethyl orthoformate
4.45
3
Methane sulfonyl chloride
1.46
62
4
Triethyl silane
0.90
N-heptane
15.00
6
Diallyl amine
0.580
7
1,3‐Dimethyl barbituric acid
0.560
IRA concemed may take m■her necessary action as per above decision ofNC
| 'Case No。:148/20/82‐ ALC4/2016 1Party Name:LEE PHARMA
‐ 1 1LIMITED
IMcet No/Date:3/82‐ Status:
1淵獄T ,"ЮК
d
密策ま
"お“
れ
「
~「
HQ File:01/82/050/01325/AM17/IRLA Flle
l ::09/24/040/00399/AM17/
|
as decided
whichever
Decision : Committee considered case as per agenda and in the presence of the technical experts, it was
to ratif, the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm w
is lower:
Export product
Exp.
Qty.
Sl.No
Import items
Qり.Allowed
in kg
SITAGLIPTIN PHOSPHATE
MONOHYDRATE
l kg
1
(3R)-3-Amino-l -[3-
(trifl uoromethyl)-5,6,7, 8-
tetrahydro- l, 2,4 -triazolol4,3 -
alpy r azi n -7 -y l)- 4 - (2,4, 5 -
trifluorophenyl)
butan- l -one
0.934蛇
RA
take
Export Product
Qty
Sl.No.
Import items
Quantity allowed
In kg
SOFOSBUVIR
lkg
1
I -((2R,3 R,4R,5 R){etrahydro-
3,4-dihydroxy-5-
(hydroxymethyl)-3 -
methylfuran-2-yl)pyrim idine-
2,4( I H,3 H)-dione
0.60
2
N-[(S)-(2,3,4,5,6-Penta
fluorophenoxy) Phenoxy
phosphinyll-L-Alanine I -
Methylethyl Ester
1.44
r
CaseNo.:25/20182-ALC4l20t6 ;Parryl.,lame:ALKALOIDS
) ,,
TCORPORATION
1821
l
，
…
…
，
１
一
IMeet No/Date:3/82¨ lstatus:Deffered
lALC4/2018 1and Re‐ indexed
105.06.2018 1
1Lic No/Date10210207123 1Defer
07‖ 2016 1Date:05.06.2018
Ms蕊i::猟↓
|;
145/AM17/
iCase No.:160/20/82‐ ALC4/2016 1ParりName:VIRUPAKSHA
10RGANICS LIMITED
IMeet No/Date:3/82-
IALC4/2018
105.06.2018
lStatus:
lApproved
IHQ File
101/82/050/01337/AM17/
IRLA File
i:09/24/040/00427/AM17/
ILic.No/Date10910064336
10311.2016
Decision : considered case as per agenda and deliberated on the matter in the presence of the technical experts and
'it was decided to ratifo the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by
:
,firm whichever is lower :
63
Decision : Deferred for comments otTE
|
'Parfy Name:MALLADI DRUGS Meet No/Date:3182-
|&PHARMACEUTICALS
ILIMITED
:ALC4/2018
105.06.2018
RA concerned may take further necessary ac●
on as per above decision ofNC
Export Product
Qり
.
Sl.No.
lmport items
Quantity allowed
In kg
Pyrrolidine Nor Ephedrine or
(( I R,2S)-Pynolidinyl nor
ephedrine)
lkg
l
Propiophenone
3.21
つ
４
Bromine
4.31
Toluene
2.50
4
Pyrrolidine
1.90
Causticsoda Flakes
5.98
6
L¨Glutamic acid
0.89
7
Acetone
2.67
ParりName:HARMONY
LIFESCIENCE PRIVATE
:LIMITED
'RLA File
103/94/040/00701/Aヽ/117/
IMeet No/Date:3/82-
IALC4/2018
105.062018
Status:Deffered
and Re-indexed
珈
匹B鸞ヨ
一
８
５
iCase No.:101/17/82‐ ALC4/2016 1Party NamciJUBILANT IMeet No/Datci3/82-
1 lGENERICS LTD iALC4/2018
1 105.06.2018
鵬雇il蔦扁
…~開
蕊鳳L;
:Lic.No/Date:0510400404
111.11.2016
Decision :Deferred for comments of TE
Export Product
Qty.
Sl.No.
Import items
Quantity
allowed in kg
DARUNAVIR
ETHANOLATE
l kg
1
(S,S)―BOC EpOxidc(or)tert―
butyl― (lS)… 1-[(2S)― o対ran_2‐
yll-2-phenylethylcarbamate
(or)(2S,3S)― BOC Epoxide
1.12
つ
４
Isobuwl amine
1.648
1薔
島鷺ji鳥
1話″
~彬
らililti上鳥
↓
‐
習
策
よ
“
ぬ化力ね
|~~|
I Dedsbn:Committee conddcrcd case as per agenda and deliberated on the maier h the presence ofthe tcchnicJ:
l experts and it was decided to ratify the ad‐
hoc input output norlns under para 4.7 ofHBP as per details below or asl
l applied by flrm whichever is lower:
‐
ILABORATORIES LIMITED IALC4/2018
1 105.06.2018
jApproved
IHQ File lRLA File lLic.No/Date:0910064386
1:01/82/050/01321/AM17/ 109/24/040/00430/AM17/ 115.11.2016
| IDecisio■:Committec considered case as per agenda and deliberated on the matter in the presence ofthe technicall
11%嚇嵩
酬
ギ協
器
my:山
“ “
おd叩正側
“
■mmsund∝
“
餞47 J HBP tt per ddails bdow∝ヽ
64
3
P-Nitrobenzene sulfonyl
chloride
1.04
4
(3R,3aS,6aD―
hexahydromr。[2,3-b]iran_3‐
y14‐ nitrophenyl carbonate
(or)NitrocOmplex(DAR―
ⅡA)
0656
5
Act市ated CarbOn(ENO― PC)
0.100
6
Methanol
5.37
7
Triethylamine
0.40
Mcthylene Dichloride
6.82
9
Isopropyl alcohol
4.94
|
|
I ---r--rr----"-,.
'RA concerned may take further necessary action as per above decision of NC
―
―
―
―
―
―
コ
| ‐Case No。:120/20/82-ALC4/2016 Paty Name:RAKSHIT
PHARMACEUTICALS LTD
:01/82/050/01297/AM17/
:Ъち刷
:0/00421晨M17/
,Decision : Deferred for comments of TE
1189
「
藤而画面画面
| :
:り010「五
`
| 101/82/050/01304/AM17/
IRLA File
109/24/040/00459/AM17/
IMeet No/Date:3/82-
:ALC4/2018
105.06.2018
| IDecislo■:Deferred fOr cOm ments Of TE
|
IMcet No/Date:3/82-
'l
lStatus: Deffered
and Re-indexed ,
IALC4/2018
10506.2018
I`No/D五i`bうi6b`44bi~bさfer l
18.11.2016 1Date:05,06.20181
:責0「liど ´~ ‐ 1良LAFiiさ …… ‐
|:01/82/050/01298/AM17/ :09/24/040/00461/AM17/
|
IMeet No/Date:3/82-
Status: Approved
1921霊胤腎
220/82-
IALC4/2018
IMcet No/Date:3/82-
IALC42018
105.06.2018
Status: Deffered
and Re-indexed
'Case No.:124120/82-ALC4/2016 Parry Name:SUVEN LIFE
SCIENCES LIMITED
IMcet No/Date:3/82‐
IALC4/2018
105.06.2018
Status: Deffered
and Re-indexed
1188
IHQ File
l:01/82/050/01301/AM17/
:RLA File
l:09/24/040/00432/AM17/
ILic.No/Date:0910064382
115.11.2016
IDefer
I)ate:05.06.2018
jDecision : Deferred for comments of TE
ICase No.:109/20/82¨ ALC4/2016 ParりName:AKTINOS
IHEALTHCARE PRIVATE
LIMITED
,Meet No/Date:3/82-
IALC4/2018
10506.2018
Status: Deffered
and Re-indexed
IHQ File
RLA File
:09/24/040/00445/AM17/
Lic.No/Date:0910064399
18.11.2016
Defer
Date:05.06.2018
ぽ∬糧紫胞職
ILic.No/Date:0910o64397 1Defer
118.11.2016 1Date:05.06.2018
ICase No.:121/20/82‐ ALC4/2016 1ParりName:HETERO LABS
ILIMITED
鍋
1
Party Name:HETERO LABS
LIMITED
65
:臨薦聯Ⅲ覆 |
IDecision t Committee considered case as per agenda and deliberated on the matter in the presence ofthe technicali
Decision : Committee considered case as per agenda and delibeiated on the matter in the presence of the technical
expefts and it was decided to ratii/ the ad-hoc input output norms under para 4.7 of HBP as per details below or as l
rapplied by firm whichever is lower :
Export Product
Otv.
Sl.No.
lmport items
Ouantity allowed
Oseltamivir Phosphate
lkg
1
Shikimlc acid
1.66
つ
４
Triethyl orthoformate
445
Methane sulfonyl chloride
1.46
4
Triethyl silane
0.90
5
N-heptane
15.00
6
Diallvl amine
0.580
7
1,3‐ Dirnethyl barbituric acid
0.560
IRA concemcd may takc fu■her nccessaw ac●on as pcr abovc decidon ofNC
■ё五;Ъ ttЪ:li'8/2レ82LALC4′
'6i`や
:■ヽ五嵩ま責ЁiЁ良6tABs ~lMもbiヽ6/Datよう′恵ダ ISあ
tiまbЪffeled l
l l lLIMITED IALC4/2018 and Re―
indexed l
‐ | 105.06.2018 1 1
193 1HQ lilも ~ ~ ~‐
1良二A File Lic.No/Date:0910064400 1Defer i
l :01/82/050/01305/AM17/ :09/24/040/00436/AM17/ 118.11.2016 1Date:0506.20181
1 二二一一――――――――― ――一‐―――^ 一一― ―一‐
一……‐
―…………
―
―一 ― ‐―^一´ ――一――‐ ,
1 区お
bn De■red br“品
menぉ。fTE ~~~~~― 一――´IIIII二五_」
## Case No.:138/17/82‐ALC4/2016 1PartyName:MAPLE CROSS
IREMEDIES PRIVATE
~~断
面｀温
3/82‐ ~~
1淵盤ぜ
1 1 1LIMITED
1194■。ri18 ~ ~
、LA Fiお
‐… …‐ ~
‐
| :01/82/050/01099/AM17/
Ю3/95/040/00624/AM17/
ILic.No/Date:0310809210
122.11.2016
IDefer
lDate:05.06.2018
iaS appliCd by fl111l whichever is lowcr i
Export Product
Qty
SI.No.
Import items
Quantity allowed
ke
BARBITURIC ACID
lkg
1
DIETHYL MALONATE
1.46
う
ι
SODIUM METAL
0.179
|
ザ
D“TⅢ郎職
り5 ~ I
D屁玉ぷIb藁手I昴■Fお品蔦苫百F罰[…
……………
_______ _
I Case No.:66/17/82-ALC4/2016 1ParりName:MEGHMANI IMeet No/Datei3/82- IStatus:Deffered
INDIISTRIES LTD. IALC4/2018 and Re‐ indexed
|
IStatus:Deffered i
and Re¨ indexed i
|
iCase No。:91/17/82¨
IALC4/2016
,Party Name:RONAK
iCHEMICALS
Mcet No/Date:3/82-
IALC4/2018
105.06.2018
rStatus: APProved
IHQ File
IRLA File
l:34/24/040/00224/AM17/
:Lic.No/Date:3410042673
:22.11.2016
,Decision : Committee considered case as per agenda and deliberated on the matter in the presence of the technical
- -- ^ . ^r r rDD ^^ -^- l^+^:l-
L-t^",
^r
I
196 1expelξ IId l was decided to ratitt the ad‐
hoclnput output norms under para 4.7 of HBP as per details below ori
66
RA concemed may takc nirther neccssav action as per abovc decision ofNC
## Case No.:120/17/82-ALC4/2016 1Party Name:ZIM
ILABORATORIES LTD.
:RLA File
:03/95/040/00602/AM17/
22.11.2016
Meet No/Date:3/82¨ lstatus:Deffered
ALC4/2018 and Re‐indexed
05.06.2018 1
Lic.No/Date:0310809205 1Defer
Date:05.06.2018
197:HQ File
:01/82/050/01081/AM17/
198 11;
|
1991器
3泥5υ01048″鳥
I茅
ICase No.:99/17/82‐ALC4ノ2016 1PartyName:SAURAV
ICHEMICALS LTD,
Meet No/Datei3/82-
ALC4/2018
05.06.2018
Licヽ。
/b五18わ】661」398 58■F ‐…
23.11.2016 1Date:05.06.2018
,D``痣i蒜:ё
`品
轟
tt`ど
`Iζ
bι:ιathι tittit``1lLざI五五
1ld it喜五ζ
dec轟さと
:も‐
tali拝81 tit lrilitt″ bi
lDML list ofapproved item showing composition.
15tti:itt i b`ferrba f。,ぁlhtitζ ofit
1lζιNIぬケ′
i7/8う:ALё4/261611五お｀品よAttlAnё b良むdも
、 1&PHARMACEUTICALS PVT.
Mcet No/Date:3/82-
ALC4/2018
05.06.2018
Lic.No/Date:0510400453 1Defer
|
:RLA File
i:22/24/040/00073/AM17/
ILTD.
T開鵬漱
24.11.2016
Status:Deffered
and Re-indexed
Status: Deffered
and Re-indexed
lDate:05.06.2018
Status: Deffered
,and Re-indexed
Status:
,Approved
ICase No.:86/17/82¨ALC4/2016 ,ParりName:ALCHEM .Meet No/Date:3/82-
IINTERNATIONAL PVT.LTD.ALC4/2018
: : 105.06.2018
200 HQ File‐
… …… …
IRLA iお ~~‐
~ |二
ぉ
:ヽも
,bitま05ib466474 うも｀:
101/82/050/01047/AM17/ 1:o5/23/040/00358/AM17/ 125.H2016 1Date:05.06.2018
1濡誡
漱
需
'需
油
“
:品纂
‐
"暮
ib=IIIII島lecideaお血品h品薔占品
「
―
IDecision:Deferred fOr comments Of TE
11:きNよli3ζ′
iウたがAttё4んbit,五●ヽ品よclPLA LiMttЁ j
お
'虚
鷺
li言款詰;~1脇j応
::塊:濡|,
Mcct No/Datei3/82-
ALC4/2018
05.06.2018
Lic.No/Date:0310809323 1
2511.2016 1
ハ
Ｖ
＊
２
＊
"`tti面
:ё6島轟118もし
6Aζ轟
`:も
a tiξも凛ぉも
liLさia五猛baまぉょ爵88 6AlAざ品農ご蓋th8 bigζ8五
``群
the i3ι 五
1■舶
:1寵:譲黒鋸::翼IT副邸
lheaι
hOchp帆0耐pl nαШ
s undttptta 47 ofHBPぉ
pcr d∝洲
sbdOw Or益
Export Product
Qty
SI.No.
Import items
Quantity allowed
Budes N 200mcg/dose
(200MD) / Budesonid Stada
N (200 MD) Budespray /
Budecort Budesonide
/ BUDEMAR 200mcg Inhaler
(200MD) wirh 63mcl Aerosol
Valve, l9ml Aluminium Can,
0.48 Actuatqr l34A HFA
lkg
1
Budesonide
0.04 gms
2
63mcI AEROSOL VALVES
Relevant as per
packing policy
3
19miALUMINIUM cAN
4
0.48 mm OD ACTUATORS
WITH DOSE COuNTER
1
I , I ,2,Tetrafluoroethane
18.2 gms
67
ICase No。:129/17/82‐ Paty Name:IDELTA
:ALC4/2016 FINOCHEM PVT.LTD.
| :
IHQ File lRLA File
101/82/050/01090/AM17/ 1:03/94/040/00675/AM17/
:Decislon:In the light of earlier decision taken by NC in its 2/82 meeting dated16.05.2018, it was decided to
汁
atitt the ad― hOC input output norrns under para 4.7 of HBP as per details below or as applied by frm whichever
1202
lis lower:
1匡
Export Product
Qty.
Sl.No.
Import items
Quantity
a1lowed Iくg
Tri Ethyl Phosphono Acetate
l Kg.
1
Tri Ethyl Phosphite
0.83 kg
2.
EthyI Chloro Acetate
0.70 kg
薔謝r“般¨瞥為
ed .
:ぶ需携血わ午
………
1
iStatus:Deffered I
:and Re-indexed ,
:,
ヽこÅ誦8~…………………
tiしヽも
/Dお:6j16憲60しウ
b‐ befci ………
1
1:03/94/040/00689/AM17/ 128.H.2016 :Date:0506.20181
'Meet No/Date:3/82‐
IALC4/2018
105.06.2018
,D;;i;i;" 'o"r".."0 ior comments or rn
: iCase No.:84/17/82‐ ALC4/2016 ,Party Name:MOREPEN IMcetNo/Date:3/82-
1 1 1LABORATORIES LTD., :ALC4/2018
‐ 1 : :05.06.2018
iHq nite
,RLA File
llic.No/Date:0510400507
:01/82/050/0lO45lAM11l :O5l24l040lO04l5lAMl7t 28.11.2016
1204
Export Product
Qty.
Sl.No.
Import items
Quantity
anOwed in kg
Candesartan Cilexetil
l kg
1
2-Ethoxy-l-[(2-(l-
triphenylmethyl - I H-tetrazol-
5 -yl)biphenyl-4-yl)methyll
benzimidazole-7 -carboxylic
acid (CS04) or Trityl
Candesartan
1.35 kg
つ
４
Cyclohexyl- I -iodoethyl
carbonate (CSSO1)
/Cyclohexyl- I -chloroethyl
carbonate
0.49 kg
¨
５
¨
０
Ｆ
１
１
つ
´
‥
１
，
:ё基3ミ礁6/Jb/82-ALё4/2016 11artyNamよζЁ
ttiiもも
: IPHARMA PVT.LTD.
1 1
‐ ‐
‐
IMcet No/Date:3/82-
lALC4/2018
105.06.2018
（
１
・
１
‥
,RA concerned may
一
一
，
，
‐
‐
‐
‥
凛
ル
‐
‐
‐
,Case
t
:Pa■y Name:ENCUBE
IETHICALSPVTLTD
: Committee considered case as per agenda and deliberated on the matter in the presence of the technical
it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as
whichever is lower:
further necessary action
]RA concerned may take
―
越
:Approved
68
IHQ File
IRLA File
Lic.No/Date:0510400571
101/82/050/01213/AM17/ 1:0524/040/00423/AM17/ 01.12.2016 1
11)eCision:Committee considered case as per agenda and deHberated on the matter in the presence ofthe technical
leXperts and it was decidcd to ratify the ad― hoc input Output nomns under para 4.7 of HBP as per details below or
as applied by Arln whichever is loweri
Export Product
Otv.
Sl.No.
Impoft items
Quantitv allowed
62/0‐ Visanergol Eye Drops O.20/0,2.5 1nl
(Net content ofbulk drug=187.040 Gms)
pack
1
Olopatadine
HCL
5.25 mg /per pack
62/0‐ OFTAHIST(010patadine Eye
Solution O.1%vial of 5ml)Net content of
)ulk drug=61.277 Gms
Pack
1
Olopatadine
HCL
5.25 mg / per pack
―
嵐
ICase No。:116/17/82‐ ALC4/2016
IMeet No/Date:3/82-
:ALC4/2018
105.06.2018
1Lic.No/Date:5210042078
02.12.2016
:Status:
Approved
IHQ File
tlrtt
lne
rNc
IPaty Name:AETHER
IINDUSTRIES LIMITED
|
~~肛
蔚
F…
~~~~―
…
1:52/24/040/00053/AM17/
206
:01/82/050/01077/AM17/
IDecision:COnl■littee considered case as pl
expefts and it was decided to ratif,i the ad-hoc input output norms under para 4.7 of HBP is per details below or as
,applied by firm whichever is lower :
Export Product
Qty.
Sl.No.
Import items
Quantity
allowed in ks
N‐OCTYL¨ D―
GLUCAMINE
l kg
1
N‐OCTYLAMINE
0.825 kg
2
D―GLUCOSE
0 770 kg
IRA conccmed may take further necessary action as per above decision OfNC
iCase No.:128/1/82-ALC4/2017
2071古。lli3 ‐
:01/82/050/01482/AM17/
## Case No.:128/17/82-
IALC4/2016
,Paty Name:STRIDES SHASUN
LIMITED
RLA File
104/24/040/00145/AM17/
IMeet No/Date:3/82‐
IALC4/2018
05.06.2018
1Lic No/Date:0410162536
02.12.2016
I
"'-'.'
'
lStatus:Deffered
.
rand Re-indexed;
:Defer
l
ioa1;:of,!o IoIt
,Status:
Approved
趙
品魔
"おず■~~|
IParりName:GLENMARK
‐Meet No/Date:3/82¨
IPHARMACEUTICALS LTD。, IALC4/2018
1 .05.06.2018
お
38月50/01089/AM17 :鷺λ刷
,0/00801ハM17/
Decision : C.ommitteeconsidered case as per agenda and deliberated on the matter in the presence of the technical
lexperts.and it was decided to rati$r the ad-hoc input output norms under para 4.7 of HBi as per details below or
las applied by firm whichever is lower:
Ｓ
‐
．
Ｎ
。
Export Product
Qty.
Import items
Quantity allowed
;Decision : Deferred for comments of TE
69
l
Clobetasol Propionate Cream USP
0.05% (Pack Size l5gm)
(Net Weight of Clobetasol
Propionate USP (Micronized) 0.38
Kgs)
Number
CLOBETASOL
PROP10NATE
USP
(MICRONIZED)
7.65 mg / 15 gm pack
つ
４
0.05% (Pack size 30gm)
Propionate USP (Micronized) 0.38
Kgs)
Number
CLOBETASOL
PROPIONATE
USP
(MICRONIZED)
15.30 mg/30 gmpack
3
0.05% (Pack size 45 gm)
Propionate USP (Micronized) 0.23
Kgs)
Number
CLOBETASOL
PROP10NATE
USP
(MICRONIZED)
22.95 mg/45 gm/pack
4
0.05% (Pack size 60gm)
Propionate USP (Micronized) 0.7 5
Kgs)
Number
CLOBETASOL
PROPIONATE
USP
(MICRONIZED)
30.60 mg / 60 gm pack
5
Clobetasol Propionate Ointment USP
0.05% (Pack size l5gm)
Propionate USP (Micronized) 0.08
Kgs)
Number
CLOBETASOL
PROPIONATE
USP
(MICRONIZED)
7 .65 mg / 15 gm pack
6
0.05% (Pack size 30gm)
Propionate USP (Micronized) 0.38
Kgs)
Number
CLOBETASOL
PROP10NATE
USP
(MICRONIZED)
15.30 mg / 30 gm pack
7
0.05% (Pack size 45gm)
Propionate USP (Micronized) 0.23
Kgs)
Number
CLOBETASOL
PROPIONATE
USP
(MICRONIZED)
22.95 mgl 45 gm pack
0.05% (Pack size 60gm)
Propionate USP (Micronized) 0.75
Kgs)
Number
CLOBETASOL
PROP10NATE
USP
(MICRONIZED)
30.60 mg / 60 gm pack
9
Clobetasol Propionate Spray 0.05%
(Pack size 59ml)
Propionate USP (Micronized) 0.30
Kgs)
Number
CLOBETASOL
PROP10NATE
USP
(MICRONIZED)
30.09 mg/ 59 mlpack
10
Clobetasol Propionate Spray 0.05%
(Pack size l25ml)
Propionate USP (Micronized) 1.59
Kgs)
Number
CLOBETASOL
PROPIONATE
USP
(MICRONIZED)
63.75 mgl 125 ml pack
RA concemed may take m“ her necessary ac●on as per above decision ofNC
2!9 ;Casg No.:78/17i8-2 -ALC4l20l6 Party Name:INDIA GLYCOLS Meet No/Date:3182-
Status:
70
⌒
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50/O1039/AMFI絣瀞蕊鳥
零漱競〒認競lXll織苦譜認驚贔
儡
l
i
Export product
Exp.
Qty
Sl.No.
lmport items
Qty. allowed
Mono Ethylene Glycol (MEG)
l kg
1
Denatured Ethyl
Alcohol
1.123 kg
2.
Silver Catalyst
0.000228 kg
Alumina Catalyst
0.000362 kg
RA may take appropriate action as per the decision of Norms Commiftee.
‐Case No.:79/17/82-ALC4/2016
Party Name:ABEERS
Mcct No/Date:3/82-
IALC4/2018
05.062018
Status: Deffered
and Re-indexed
IPHARMACEUTICALS PVT
:LTD
10
12
|
|
:
,
|
|
な
|
:
|
1
諄Q Fne
101/82/050/01041/AM17/
IPHARMACEUTICALS PVT
:LTD
IALC4/2018
0506.2018
IStatus:Deffered l
and Re― indexed l
‐Defer ‐
Date:05.06.2018
:RLA File
:05/23/040/00424/AM17/
Lic.No/Date:0510400658
10712.2016
i ciζきヽま
:Йう′
ib/82:ALC4/'61`II:■NamまHIN5VぎLAb討i
l l :LTD
12薔。hぉ
…
…
一
ヽ
LA面
`‐
~…
| 101/82/050/01319/AM17/ 1:09/24/040/00492/AM17/
IDecision:Deferred for comments of TE
IMcet No/Date:3/82‐
ALC4/2018
'05.06.2018
1Lic.No/Date:0910064449
107.12.2016
'Status:Deffered'
and Re-indexed
oefei
Date:05.06.2018
Ｆ
Ｉ
Ｉ
…
…
―
１
２
‐
３
‐
‐
IGENERICS LTD
IALC4/2018
105.06.2018
rStatus:
lAPProved
HQ File
l:01/82/050/01198/AM17/
ヽRLA Flle
i:05/23/040/00402/AM17/
ILic.No/Date:0510400685
'08.12.2016 1
Decision : Committee considered case as per agenda and deliberated on the mafter in the presence of the technical
iexperts and it was decided to ratiff the ad-hoc input output norms under para 4.7 of HBP as per details below or as
'applied by firm whichever is lower:
Export Product
Qty.
Sl.No.
Import items
Quantity
allowed in kg
CITALOPRAM TABLETS
USP10 MG
lNo.
1
Citalopram Hydrobromide
12.49 1ng
ヽ
RLA File
ILic.No/Date:0510400659 1Defer
:01/82/050/01040/AM17/
07.12.2016
Date:05.06.2018
71
:R
CITALOPRAM TABLETS
USP 20 MG49.96 mg
CITALOPRAM TABLETS
USP40 MG
Citalopram Hydrobromide
A concerned may take further necessary action as per above decision of NC
iCase No.:22/20/82‐ALC4/2016 1ParりName:JUBILANT
IGENERICS LTD
IRLA File
105/23/040/00404/AM17/
IDecision:Deferred for comments of TE
214 1HQ File‐ ‐ ……‐~ ‐
……―
::01/82/050/01199/AM17/
Lic.No/Date:0510400686
108.12.2016
もtitまbLffeLl l
,and Re‐ lndexed l
′ |
′ |
3壺1::i:ち:|:‐
1
ふ
ドiCase No.:81/17ノ82‐ALC4/2016 1P釘
～N`
iCaseNo.:81/17ノ82‐ALC4/2016 1P釘りName:BIO TECH
IMeetNo/Date:3/82‐ IStatus:
:OPHTHALMICS PVT LTD
IALC4/2018
'05.06.2018
rApproved
つ
４
RLA Flle
~~~~ 1吾
Iヽ11,ヽIill術゛
i卜iibうヽア
~■
‐
:08/24/040/00360/AM17/
:Lic.No/Date:0810139254 1
109.12.2016
experts and it was decided to ratif,z the ad-hoc input output norms under para 4.7 of HBP as per details below or as
applied by firm whichever is lower:
Export Product
Qty.
Sl.No.
Import items
Quantity
allowed
BIO HYALUR SV l.6 ML
PFS
(SODIUM
HYALURONATE
OPHTHALⅣIIC
SOLUTION 3%)
6000.000
Numbers
1
SHISEIDO SODIUM
HYALURONATE SZE
GRADE EP
293.76 gm
2
BARRELS(HYPAK SCF
2.25 ML RFPRTC FM 27)
(COMPONENT FOR
PMFILLED
SYRINGE)(HEIGHT 73.30
MM,DIAMETER
(EXTERNAL)10.85MM
DIAMETER(INTERNAL)
8.65MM(+/…
100/0))
Relevant as
per packing
policy
PLUNGER ROD(HYPAK
PR 2.25 ML PP)
(COMPONENT FOR
PREFILLED
SYRINGE)(LENGTH 58.52
MM T060.10 MM,WIDTH
ll.99 MM T0 12.75 MM
(+/-10%))
Relevant as
per packing
policy
4
PLUNGER STOPPER
(HYPAK BSCF l-3 MLPH
ML PH 701/50C BLK SI
1000 WWD)
(COMPONENT FOR
PREFILLED SYRINGE
HEIGHT 7.7MM,OUTER
DIAMETER 9.15 MM,
INNER DIAMETER 6.25
Relevant as
per packing
policy
Conlmiice consdered casc as per agenda and deliberated on me matter in the presence ofthe technicali
72
MM←/-10%))
BACK STOP(BACK STOP
l-3 ML PP CLEAR)
(COMPONENT FOR
PREFILLED SYRINGE)
(LENGTH 24.2MM,
WIDTH 16.50 MM,
HEIGHT 5.lMM(+/-10%))
Relevant as
per packing
policy
6
BLISTER(PP BLISTER
2.25ML/30 ML)
(PACKINGMATERIAL
FOR PREFILLED
SYRINGE)
Relevant as
per packing
policy
7
CANNULA(COMPONENT
FOR PREFILLED
SYRINGE)
(OUTER DIAMETER 040
MM T0063 MM(+/¨
10%))
Relevant as
per packing
policy
8
TYVEK LID(PACKING
MATERIAL FOR
PREFILLED SYRINGE)
(LENGTH 144 MM,
WIDTH 50 MM∈/-10%))
Relevant as
per packing
policy
concerned may take further necessary action as per above decision ofNC
⌒
|
|[
IRA
l iCase No.:37/20/82‐ ALC4/2016 Pa●y Name:10L CHEMICALS IMcet No/Date:3/82- iStatus:Deffered:
:AND PHARMACEUTICALS IALC4/2018 and Re¨ indexed l
, ILIMITED 05.06.2018 1 1
| ,
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1161綿膨
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百な諸
1:1:ふ11
1 1Decision:Deferred for comments ofTE I
Status: Deffered
113.12.2016
:and Re-indexed
,Defer
,Date:05.06.2018
辞¶慨扁蕊蕊テ
~…
間薦蕊i鮮~諄
蠍
:Lic.No/Date:0810139274
lDecision : Deferred for comment of TE
10PHTHALMICS PVT LTD
1312.2016
ICase No.:118/20/82-ALC4/201`ParサNameiSUVEN LIFE Meet No/Date13/82- Status:Deffered
'SCIENCES LIMITED IALC4/2018 1and Re‐
indexed
i 105.06.2018
217 Hq nit.
:RLA File
ILic No/Date:0910064464 1Defer
|:09/24/040/00472/AM17/ 109.12.2016
IDate:05.06.2018
ICase No.:9/20/82¨ ALC4/2016 ParけNamc:BIO TECH Mcct No/Datei3/82- IStatus:Deffered
105.06.2018
73
220
Decision : Deferred for comment of TE
iCase No.:146/17/82‐ ALC4/2016 Paty Name:CIPLA LIMITED. IMcet No/Date:3/82-
IALC4/2018
:Status:
l
| |
●062018 1~ |
:Q田
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α
“
血面血
:~~|
‐Decision:Comlnittee considered case as per agenda and deliberated on the matter in the presence ofthe technicall
experts and it was dccidcd to ratitt the ad‐ hoc input output nolllls undcr para 4.7 of HBP as per details bclow or as
applied by flrln whichever is lower:
Export product
Exp.
Qty.
Sl.No.
Impoft items
Qty. allowed
mg/tablet
Tenofovir Disoproxil Fumarate
300mg+ Lamivudine 300mg +
Efavirenz 600mg Tablets
Numbers
1
Efavirenz
612.0
2
Lamivudine
306.0
9-[2‐ (PhoSphonyl Methoxy)
Propyl]Adenine(PMPA)
235.3
4
Chloromethyl Isopropyl
Carbonate
413.92
5
N-Methyl 2-Pyrrolidone
455.27
6
Methylene Dichloride
2050.20
RA may take appropriate action as per the decision of Norms Commiftee.
Case No。:19/1/82‐ ALC4/2017
ParりName:IND‐SWIFT
LABORATORIES LTD.,
Meet No/Date:3/82-
ALC4/2018
05.06.2018
:Status:lDeffered
iand Re‐ indexed
221
IHQ File
:01/82/050/01373/AM17/
IRLA File
l:22/24/040/00081/AM17/
Lic.No/Date:2210015609 1Defer
13.12.2016 11)ate:05.06.2018
ICase No.:142/17/82¨ ALC4/2016 Party Name:JINDAL DRUGS
‐PRIVATE LIMITED
'Mcet No/Date:3/82‐
IALC4/2018
:05.06.2018
IStatus:
:Approved
HQ File
RLA File
Lic.No/Date:0310809757 Defer
:01l82l050l0l1O3lAMl7l :031941040100818/AM 171
13.12.2016
,Date:05.06.2018
222 experts and it was decided to rati$ the ad-hoc input output norms under para 4.7 of HBP as per details below or as
applied by firm whichever is lower:
Export Product
Qty.
SI.No.
Import items
Quantity
allowed in kg
PURE CINEOLE
l kg
1
EUCALYPTOL OIL
1.05 kg
RA concemed may takc hrther neccssary action as per above dccision ofNC
## Case No.: l43l17l82-ALC4l20l6 Party Name:JINDAL DRUGS Meet No/Dat e:3182-
HQ File
:01/82/050/01104/AM17/
PRIVATE LIMITED
RLA File
:03/94/040/00819/AM17/
IALC4/2018
05.06.2018
‐Lic.No/Datei03 10809758
■3.122016
IStatus:Deffered
land Rc‐ lndcxcd
lDefer
lDate:0506.2018
223
74
（
‐
‐
‐
‐
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「
224
:器3児5υOりりAM17
器ち刷iυ0044yAM17
サ
ぢ%Rl°
05104007891 1
:Decislon:Commitee considered case as per agenda and deliberated on the matter in the presence ofthe technical.
leXperts and it was decidcd to ratl取
the ad― hoc input output norms under para 4.7 of HBP as per details below o■
las applied by firm whichever is lower:
Export Product
Qty.
lmport items
Quantity
allowed
Timolol Maleate Long Acting
Ophthalmic Solution, 0.5oh wlv, 5 ml
(TTMOLET OD)
Each ml contains Timolol Maleate 6.83
mg equivalent to Timolol 5 mg
(Equivalent to 68.300 Gram of Bulk
Drus)
2000.000
Number
TIMOLOL MALEATE
USP
344.85 gm
Latanoprost and Timolol Maleate
Ophthalmic Solution, 0.005% I 0.5%
wlv,2.5ml (LATOCOM Sterile Eye
Drops)
Each ml contains Timolol Maleate 6.83
mg equivalent to Timolol 5 mg
(Equivalent to 269.785 Gram of Bulk
Drug) (Equivalent to 338.085 Gram of
total Bulk Drug) Drug Formulation/
Formulation Grade
15800.000
Number
: I Fomulation Grade l l
lRA concemed may take irther necessary ac●on as per above decision ofNC
」
Mcet No/Date:3/82-
ALC4/2018
10506.2018
iCase No.:213/17/82-ALC4/2016
Status:
Approved
IHQ Flle:01/82/050/OH 74/AM17/IRLA File tic.No/Datei0810139295
1 :08/24/040/00321/AM17/ .15.12.2016
1Decision:Commi■ee considered the case as per agenda and in the light of ea‖ ier decision taken in meeting no.
1/82 dated 04.04.2013, it was decided to ratify norms under Para 4.7 of HBP vl as per details given below or as
applied by the firm, whichever is less:
Paty Name:CADILA
HEALTHCARE LTD
Item ofExport
Item of Import
Quantity allowed
for 100 vials
AZITHROMYCIN
INJECT10N 500MG
(SUMAMED
INJECTION 500MG)
1 00 vial
AZITHROMYCIN
DIHYDRATE PH EUR.
SODIUM HYDROXIDE
PH.EUR
0.140 gm
20 ML20 MM CLR TYPE‐
H LYO INJ
Relevant, as per
packing policy
RS CB LTO RTU(AT
V9172 FM 140/6)
20 MM TEAR OFF
| IDecision:Deferred for comments of TE
1225
Quantity
S,No
55.0305 gm
2
4.
75
may take appropriate action as per the decision of Norms Committee.
iCase No.:176/17/82-ALC4/2016
Paty Name:GITANJALl
lCHEMICALS PVT LTD
,Meet No/Datei3/82- Status: |
IALC4/2018 1Approved
‐
105.06.2018 1 1
IHQ File RLA File l=itiヽ
3/bitもib」ib恵60なも1 1
‐ ~~~~|
:01/82/050/01137/AM17/ :03/94/040/00741/AM17/ 115 12.2016 1
1Decislon:Committee considered case as per agenda and deliberated on the ma■er in the presence ofthe technicali
の6:l露
篤
|ぶ需
∬翠
:脚]:ぬ
ed・∝hp前面四nomS m“rμm 47」HBPぉ
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洲s ttbW¨
Exporl Product
Qty.
Si.No.
Import items
Quantity
allowed in kg
4-CHLORO-4-HYDROXY
BENZOPHENONE
l kg
l
PHENOL
0.810 kg
2
PARA CHLORO
BENZOYL CHLORIDE
1.045 kg
227
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':ALё
4′,diデ
~.11■
NanlもiSRIAM LAЁζ IMも8iヽ8'5:18t/恵夕‐ も
titiζ …
:
‐
PRIVATELIMITED I諸
″ 獄
ぜ tpproVed
‐
1鵠虚
::蕊11ふふ
|:チ
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揚璃
::1:鳳I↓|; 1努お甥需おう
ib6644蕊|~~~~|
1)ecision:C3mmittec considered casc asberagendaand deliberated ontie matterin the presenc8 ofthet`chnicail
experts and it was decided to ratl取
the ad_hoc input output norlns under para 4.7 of HBP as per detalls below or as
lapplたd by nrm whicheveris lower
Export Product
Qty.
Sl.No.
Import items
Quantity
allowed
TRIMIPRAMINE
MELEATE
l kg
1
IMINODIBENZYL
0.53 kg
2
3‐N,N Dimethyl Amino-2-
MethyI Propyl Chloride HCL
0.72 kg
:RA concemed may take fu“ her necessaw acuon as per above decision ofNC
l iCase No.:53/20/82-ALC4/2016
1器:。品一‐
…
…
| |:01/82/050/01230/AM17/
IParりName:TORIN ORGANICS
PVT LTD
IMeet No/Date:3/82-
ALC4/2018
10506.2018
Status:Deffered
and Re-indexed
IRLA File
:35/24/040/00011/AM17/
ILic No/Date13510045081 1Defer
‐21 12.2016 Date:05.06.2018
1229
1
ICase No.:124/1/82¨ALC4/2017 Party Name:TORIN ORGANICS
IPVT LTD
|
IHQ File lRLA File
:01/82/050/01478/AM17/
135/24/040/00070/AM16/
Mcet No/Date:3/82-
IALC4/2018
105062018
1Lic No/Date:3510045080
121.12.2016
Status: Deffered
,and Re-indexed
Defer
Date:05.06.2018
Party Name:CADILA
IHEALTHCARE LTD
:Meet No/Date:3/82-
ALC4/2018
醤需糧蹂粗
::|
230 :Case No.:54/20/82‐ALC4/2016
―
l
AL.SEAL ATB
76
「
|
―
「
IHQ Filc iRLA File
:01/82/050/01231/AM17/ 108/24/040/00320/AM17/
,Decision : Deferred for comments of TE
105.06.2018
ILic.No/Date:0810139351
122.12.2016
⌒
「
~~~~~~~~~――
―
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123.12.2016 1Date:05.06.2018
IMcet No/Date:3/82-
:ALC4/2018
105.06.2018
rStatus:Deffered
.
.and Re-indexed
■
警`馬
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ν82 1聯
: 1 1 05.06.2018 1
1 1HQ File iRLA File Lic.No/Date:0810139382 1
Decision : Del'erred lbr comments of TE
Export Product
Qty.
Sl.No.
lmport items
Quantity
allowed
Hyaluronic Acid Solution
3% - GLODERM 30 (lML
PFS)
(Composition 3Omg / ml)
(Total containing of bulk
drug 96 gram)
3200.000
Numbers
1
HYALURONIC ACID BP
97.92 gm
Number
2
BARRELS(HYPAK SCF l
M LL RF PRTC 7025/65)
(COMPONENT FOR
PREFILLED SYRINGE)(
HEIGHT 72.90 MM,
DIAMETER EXTERNAL
8.15,DIAMETER
INTERNAL 635 MM(+/―
10%))
Relevant as
per packing
policy
3
PLUNGER STOPPER(
HYPAK BSCFl M LL PH
701/50 BLK S11000 PPL)
(COMPONENT FOR
PREFILLED SYRINGE)(
HEIGHT 72.90 MM,
DIAMETER EXTERNAL
8.15,DIAMETER
INTERNAL 6.35 MM(十
/_
10%い
Relevant as
per packing
policy
4
HYPODERMIC NEEDLE
30G X 13 mm(1/2")
(COMPONENT FOR
Relevant as
per packing
nolicv
| IHQ File iRLA File Lic.No/Date:0810139382 1
1 101/82/050/01233/AM17/ 108/24/040/00401/AM17/ 127.12.2016 1
| lbtcision:Commilおき66nsidered case as per agenda and deliberated on the maier in the presence ofthe technical
l
lexperts and it was decided to ratif the ad-hoc input output norms under para 4.7 of HBP as per details below or as
rapplied by firm whichever is lower:
I
I
I
I
lallowed I
1233
1
||
| ||
|
1231
.Case No.:5011182-ALC4l20l7 lParty Name:CLARIANT INDIA ,Meet No/Date:3182-
LIMITED
:ALC4/2018
105.06.2018
lStatus:Deffered
land Re-indexed
6慧ibo9う 158fer l
IDate:05.06.2018
IHQ File
101/82/050/01404/AM17/
:RLA File
i103/94/040/00881/AM17/
23.12.2016
77
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，
・
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―
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―
―
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: l l : l
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.
:RA concemed may take miher necessary action as per above decおion ofNC
PREFILLED SYRINGE)
TYVEK LID(PACKING
MATERIAL FOR
PREFILLED SYRINGE)
(LENGHT 144 MM
WIDTH 50 MM(+/… 10%)
Relevant as
per packing
policy
6
BLISTER(PACKING
MATERIAL FOR
PREFILLED SYRINGE)
(THIS LICENCE IS
ISSUED AS PER POLICY
CIRCULAR N0 9(
u2003)2002-2007
DATED 30/06/2003&
CIRCULAR N0 15 DATED
17/09/2003.
Relevant as
per packing
policy
溺
## Case No.:4ノ1/82-ALC4/2017
RLA Flle
:09/24/040/00509/AM17/
:Lic.No/Date:0910064538
128.12.2016
Decision : Committee considered case as per agenda and deliberated on the matter in the presence of the technicat
:experts and it was decided to ratifz the ad-hoc input output norms under para4.7 of HBP as per details below or as
234攣メお
d by irln wnchever、bwcr
Export Product
Qty.
Sl.No.
lmport items
Quantity
anOwed in kg
Propyl Paraben
Sodium/Sodium Propyl
Hydroxy Benzoate/Sodium
Propyl Para Hydroxy
Benzoate BPruSP/EP
l kg
1
Para Hydroxy Benzoic Acid
(PHBA)
0.714 kg
2
N-Propanol
0.310 kg
RA concerned may take funher necessary action as per above decision of NC
:HQ Flle
::01/82/050/01358/AM17/
Export Product
Qty.
Sl.No.
Import items
Quantity
allowed in ks
Agioseptol Powder 500 Gm
Pouch Packing
Each Gram Contains
Sulfathiazole Norsulfazole
BP 80 mg Sulfaguanidine
Sulgin BP 70 mg
Trimethoprim BP 30 mg
Oxytetracycline
Hvdrochloride BPV 45 ms
200 kg
1
Sulfathiazole
Norsulfazole BP
80.80 kg
2
Sulfaguanidine
Sulgin BP
70.70 kg
Name:RASULA
IMcet No/Datei3/82-
:ALC4/2018
105.06.2018
ｏ
ｖ
ｅ
一
ｒ
一
ｐ
一
ｐ
一
Ａ
一
iCHEMICALS
per agenda and deliberated on the matter
.leXperts and it was decided to ratl取the ad― hOC input output nolllls under para 4.7 ofHBP as pcr details below or asI
Iapplied bv flrm whichever is lower
78
: ICase No。:6/1/82-ALC4/2017 P釘りNamc:INFINITY IMcet No/Date:3/82‐ ,Status:Deffered
:, LABORATOⅢ
∬Ⅳ■F臥
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ρ5.06.2018
losin Tartrate BPV 25
「%姉¨丁丁=襦iに
鶴掏2硼観5静~
IHQ Filc lRLA File lLic.No/Date12210015625 1Defer
101/82/050/01360/AM17/ 1:22/24/040/00083/AM17/ 12912.2016 1)ate:0506.2018
Decision :Deferred for comments of TE
RA concerned may take further necessary action as per above decision ofNC
ICase No.:58/1/82-ALC4/2017 1Party Namc:GITANJALI IMeet No/Date:3/82‐
ICase No.:58/1/82-ALC4/2017 1Party Namc:GITANJALI IMeet No/Date:3/82‐
IStatus:
| ICHEMICALS PVT LTD IALC4/2018 1Approved
105.06.2018
1HQ File RLA File Lic No/Date:0310810278 1
101/82/050/01412/AM17/ 1:03/94/040/00855/AM17/ 103.01.2017 1
:Decision:In the light of earlier decision taken by NC in its 19/82 mec傾
ng dated 02.01.2014,it was decided tol
| :Decision:In the light of earlier decision taken by NC in its 19/82 mec傾
ng dated 02.01.2014,it was decided tol
137精格lhead~h°
c hp■outp耐norms underpara 47 of HBP as per ddtts bdow oras apttd by nm whchever、
llower:
Export Product
Qty.
Sl.No.
Import items
Quantity
allowed in ke
4-CHLORO‐ 4-HYDROXY
BENZOPHENONE
l kg
1
PHENOL
0.810 kg
う
４
PARA CHLORO
BENZOYL CHLORIDE
1.045 kg
:‐
で
1:もヽまおシi/82-ALё 4たbiケ |II轟ヽ品じ
11こLMSiё
~ ~IM881ヽも
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btffeledi
1 1 1PHARMACEUTICALS LTD IALC4/2018 and Re‐
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11■ま
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l l lPHARMACEUTICALS LTD IALC4/2018 and Re‐
indexed l
105.06.2018 1 1
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l∴1誠語 ヽら脇1機誠↓1, 1総癬まЙ而軌ぬ
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18
1 :Detti`IIbeferiedおltも話品titζ 6i十五 ……‐ ‐~ ~―
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― ―― ― |
I ICase No.:22/1/82‐ ALC4/2017 1Paty Name:ASCENT
I l iFINECHEM PVT.LTD.,
| | :
| | IFINECHEM PVT.LTD., IALC4/2018 and Re―
indexed l
l l : 10506.2018 1 1
:"臨
λ島∴鳳
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,Meet No/Date:3/82-
IALC4/2018
105.06.2018
ILic.No/Date:0510401159 1Defer
05.01.2017 1Date:05.06.2018
丁
|
:~|ム:ざ雨6153たんi:ALё4/2617‐
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l
241 1 1 1ALC4/2018 1Approved l
l l l 105.06.2018 1
‐
:
逼
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11 ~
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……‐~~~
jStatus:Deffered
land Re-indexed
ヘ
:01/82/050/01407/AM17/
79
-- lovealoaorooel s/AMr z
Decision : ,
experts and
applied by
l..=-
Committee considered case as per agenda and deliberated on the matter in the presence of the technical
I it was decided to rati$/ the ad-hoc input output norms under para 4.7 of HBP as per details below or as
firm whichever is lower:
Export Product
Qty.
Sl.No.
Import items
Quantity
allowed
Ipratroplum Bromide 20mcg and
Salbutamol Sulphate 100mcg
lmaler(200MD)DUOLIN
INHALER(200MD)
Number
1
Ipratropium
Bromide
4.00 mg
つ
４
63mcl AEROSOL
VALVES
Relevant as per
packing policy
19ml
ALUMINIUM
CAN
4
0.58 mm OD
ACTUATORS
WITH DUST
COVERS/CAPS
Heptafluropropane
P227 Gas
21.10 mg
|| | | I P227 Gas
RA concemed may take further necessary action as per above decision ofNC
」
獅
‐
ICase No.:56/1/82‐ ALC4/2017 ParりName:GLENMARIC IMeet No/Date:3/82- lStatus: |
| IPHARMACEUTICALS LTD., IALC4/2018 1Approved l
105.06.2018 1 ‐
IHQ File lRLA File lLic.No/Date:0310810390 1 1
101/82/050/01410/AM17/ :03/94/040/00822/AM17/ 109.01・2017 1 1
1)ecision:Committee considered case as per agenda and deHberated on the matter in the presence ofthe technicall
experts and l was decidcd to ratl～the ad_hoc input output norms under para 4.7 of HBP as per details below or
experts and lt was decrded to ratlfy th
,as applied by firm whichever is lower:
l
)
Ｓ
‐
．
Ｎ
。
Export Product
Qty.
Import items
Quantity allowed
1
0.05% (Pack Size l5gm)
Propionate USP (Micronized) 0.38
Kgs)
Number
CLOBETASOL
PROPIONATE
USP
(MICRONIZED)
7 .65 mg / 15 gm/pack
つ
乙
0.05% (Pack size 30gm)
Propionate USP (Micronized) 0.38
Kgs)
Number
CLOBETASOL
PROPIONATE
USP
(MICRONIZED)
15.30 mg/30 gm/pack
0.05% (Pack size 45 gm)
Propionate USP (Micronized) 0.23
Kgs)
Number
CLOBETASOL
PROPIONATE
USP
(MICRONIZED)
22.95 mgl45 grn/pack
4
0.05% (Pack size 60gm)
Propionate USP (Micronized) 0.75
Kgs)
Number
CLOBETASOL
PROP10NATE
USP
(MICRONIZED)
30.60 mg 160 grn/pack
1242
10601.2017
| |
80
0.05% (Pack size l5gm)
Propionate USP (Micronized) 0.08
Kgs)
Number
CLOBETASOL
PROP10NATE
USP
(MICRONIZED)
7.65 mg / 15 gm/pack
6
O.05%(Pack SiZe 30gm)
Net Weight ofClobetasol
Propionatc USP(MiCrOnized)0.38
Kgs)
Number
CLOBETASOL
PROPIONATE
USP
(MICRONIZED)
15.30 mg 130 grnlpack
7
0.05% (Pack size 45gm)
Propionate USP (Micronized) 0.23
Kgs)
Number
CLOBETASOL
PROPIONATE
USP
(MICRONIZED)
22.95 mgl45 gmlpack
O.05%(Pack SiZe 60gm)
Net Weight ofClobetasol
Propionate USP(MiCrOnized)0.75
Kgs)
Number
CLOBETASOL
PROP10NATE
USP
(MICRONIZED)
30.60 mg 160 gmlpack
9
Clobetasol Propionate Spray 0.05%
(Pack size 59ml)
Propionate USP (Micronized) 0.30
Kgs)
Number
CLOBETASOL
PROPIONATE
USP
(MICRONIZED)
30.09 mg/ 59 ml pack
10
Clobetasol Proplonate Spray O.050/0
(PaCk SiZe 125ml)
(Net Weight ofClobetasol
Propionate USP(MiCrOnized)1.59
Kgs)
Number
CLOBETASOL
PROPIONATE
USP
(MICRONIZED)
63.75 mg/ 125 ml pack
tt,t
Decision : the light of earlier decision taken by NC in its meeting 282 GtBd,)i.oq.ioi,it w;s decided to ratifo
243 1noms under Para 4.7 of HBP vl as per details given below Or as applied by the flrln,whichever is less:
!
Export Product
Export
Quantity
S.No
lmport Product
Quantity Allowed
Barbituric Acid
l kg
1
Di-Ethyl Malonate
1.46 kg
2.
Sodium Metal
0.179 kg
may take appropriate action as per the decision of Norms Committee.
ICase No.:170/20/82-ALC4/2016 P釘りName:RONAK IMeet No/Datei3/82- Status:
1 lCHEMICALS :ALC4/2018 1Approved
i l
わ5.06.2018 :
「
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441
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４
Pa●y Name:AARTI DRUGS IMeet No/Date:3/82- istatus:Deffered l
lLIMITED ALC4/2018 and Re‐ indexed l
05.062018 1
IRLA File
:03/94/040/00900/AM17/
:01/82/050/01409/AM17/
ILic.No/Date:0310810464 1Detr
ll.01.2017 Date:05.06.2018
81
〈
‐１
１
鳥
ヽ
l
|
|
:245
ICase No.:54/1/82‐ ALC4/2017 :Party Name:AARTI IMcet No/Date:3/82-
I INDUSTRIES LlMITED IALC4/2018
. :05.06.2018
1
1HQ File lRLA Filc :Lic.No/Date:0310810483
:器肌
5υOИO"AM17
錨
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:ボち認
iStatus:Deffered
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!
|:鳶L5.06.20181
|
:246
:Decislon:It was decided to can fronn the firm technical details as per appendix 4E
…1
撃
蘭冽
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稔
締
∬
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レ
di
l :
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‐
…
´
‐ | ~
‐ ~
‐ ~ |
‐
…
… ~~~~1
lHQ File:01/82/050/01381/AM17/RLA Fle lLic.No/Date:0810139533 1 :
:認孵
:^~~~ψコ
~ψ V一………Ⅲちガ応五υ
00323ハM17 ●6iち諦~~~…~ | |
1翠lξ鳳:‖量糖i謂:習:結籠]蝋撚撚1掘11∬諄鼎害器玉T猟鳳鼎電
l嗅
|
| :I:|∫
|:Sillili00MGand800ⅣIGTabletS
S.NO.
Import Items
Norms recommended for export I No. Tablets
400mg Tablets
800 mg Tablets
1
ACYCLOVIR USP
408.O Ing
816.0 mg
2
100 CC white Bottle HDPE
(AS PER GENERAL POLICY FOR
PACKING MATERIAL¨ PACKING
MATERIAL IN FINISHED FORM― NET
NOS.385520)
Relevant, as per packing policy
3
38 MM Liner Caps
4
500 CC white Bottle HDPE
5
NCRC Cap 45 MM Liner
6
225 CC white Bottle HDPE
7
NCRC Cap 53 MM Liner
950 CC white Bottle HDPE
IRA may take appropriate action as per the decision of Norms Committee.
IDecision:Deferred for comments of TE
A ~ IMも
`tヽ
。
/D嘉31j慧2‐ ~~|も11■::Deffered l
l lCase No.:28/1/82-ALC4/2017 1Paty Name:CADIL
: , IHEALTHCARE LTD IALC4/2018 1and Re―
indexed l
:05.06.2018 . :
｀ :05.06.2018 1 :
247章
。liぉ
… ~~~~―
― RLA File ~~~~~~~―
,I、も/D品10810漱廃デ
~ま
befer…
…
…
:
::01/82/050/01382/AM17/ :08/24/040/00430ハM17/ 113.01.2017 :Dtte:05.06.2018:
248iCase No.:52/1/82‐ALC4/2017
ParりName:CIPLA LIMITED. IMeet No/Date:3/82-
:Status:
壼
82
1 ~~~~蒻~~~ ~聞
蘊丁
……~~
im而
/050/O1406両面″訛蕊所蕊議ぶ鳥」
~~臨
漑汗赫
J~
Approved ,
experts and it was decided to ratifu the ad-hoc input output norms under para 4.7 of HBP as per details below or as
,applied by firm whichever is lower:
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. allowed
mg/tablet
Tenofovir Disoproxil Fumarate
300mg+Lamivudine 300mg十
Efavirenz 600mg Tablets
Numbers
1
Efavirenz
612.0
2
Lamivudine
306.0
9-[2‐ (PhoSphonyl Methoxy)
Propvll Adenine(PMPA)
235.3
4
Chloromethyl I sopropyl
Carbonate
413.92
N― Methy1 2-Pyrrolidone
455.27
6
Methylene Dichloride
2050.20
may take appropriate action as per the decision of Norms Committee.
Lic No/Date:3410042838
11601.2017
▲
「
PiV▼'V I
:
………――― ―――●
:
麒
,
,Case No.:25ll/82- ALC4/2017 Party Name:AUROBINDO tMeet No/Date:3182- istatus:Deffered
I
PHARMA LIMITED
,ALC4l2olg
land Re-indexed,
05.06.20 I 8
陶
蕊
高
扁
~~踊
鳳
鳥
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~輛
需
:嚇
蒟
´
臨
島ふ
髯
1
扇
高
品
Б
悪
面
葛
葛
蔦
面
高
面
」
~~~~~~一
一
―
―
一
―
―
―
―
…
…
一
一
一
―
―
一
一
―
―
|
l iCase No.:34/1/82-ALC4/2017 Party Namc:REINE
ILIFESCIENCE
IMcct No/Date:3/82- Status:
IALC4/2018 1Approved
105.06.2018 1
菫0赫
/050/O138脱ぶ瀞7襄鰤謙ile ……………‐
…
l i:34/24/040/00276/AM17/
iDecision : Committee considered case as per agenda and and
,decided to ratifu the ad-hoc input output norms under para 4.7
in the presence of the technical experts, it was
of HBP as per details below or as applied by firm
IWhiChever is lower
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed
in kg
Atorvastatin Calcium
l kg
1
(4R-Cis)-, I - I -Dimethylethy-
6-cyanomethyl-2,2-dimethyl-
1.3-dioxane-4 acetate
0.708
2
4-Fluoro-alpha-(2-methyl- I -
oxopropyl) gamma-oxo-N-
beta-diphenyl benzene
butanamide
0.994
Methanol
6.79
4
Acetone
159
250
l iCase No.:24/1/82-ALC4/2017
12511
Paty Name:SUN
IPHARMACEUTICAL
IINDUSTRIES LTD
IMeet No/Datc:3/82-
Status:
l
'Approved
',
:
IALC4/2018
105.06.2018
83
1Lic.No/Date:0510401320 1
1HQ File:01/82/050/01378/AM17/IRLA File
, 105/24/040/00508/AM17/ 117.012017 1
15`tisiもI fё6imite8 86五ζ
ttered 8:ζ
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i
experts and it was decided to ratitt the ad‐hoc input output norlns under para 4.7 ofHBP as per details below or as
applied by f1111l WhiChever is lower
l Export Product
lclarithromycin Carbomer Granules 43.5%/43.75%/44%―
-l kg
S.NO.
Import Items
Norms recommended for export of I kg
1
Clarithromycin
Or its raw material as per SION A-2263 on
oro-rata basis
0.4394 kg
2
Carbopo1 974P
0。370 kg
RA may take appropriate action as per the decision of Norms Committee'
ICase No.:76/20/82-ALC4/2016 ParりName:WANKSONS
ICHEMICAL INDUSTRIES
IPVT.LTD.
,Mcct No/Date:3/82-
:ALC4/2018
:05.06.2018
ILic.No/Datei0310810695 1
123.012017 1
1
Status:
Approved
IHQ File:01/82/050/01253/AM17/ RLA Filc
:03/95/040/00807/AM17/
. in the presence of the technical experts, it was
of HBP as per details below or as applied by firm
1253
Export product
Exp
Qty.
SI No.
lmport items
Qty.Allowed
in kg
META CHLORO
PROP10PHENONE(lTC(HS)
CODE 29147090&29143990)
l kg
l
PROPIONYL CHLORIDE
1.120
2
ETHYLENE DI CHLORIDE
0.797
ALUMINIUM CHLORIDE
2.797
4
N―HEXANE(ITC(HS)
CODE 29011100&
98020000)
0.997
BENZENE
0.997
I RA may take appropHate ac●on as perthe decision ofNorms Committee
」
I
ISPECIALTIES LTD
tALC4l20l8
iApproved
l
'05'06'2018
Lic.No/Date:0310810742 1 1
:54,Q RL:01慇
2/050Ю 1274/AM17.碗
λttiO/00781/AM17/ 24.01.2017 1 1
1 15tcisお1:i“
`iight oftarlicr18ふ
ζ6i tak`hも,~ヽこlA託ζシを
'品
きiふLa品ど1どbζ ヵbiを,I続きaざとidelば:ょ111
ithe ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
]Party Name:RUSAN PHARMA
ilro.
IMeet No/Datei3/82‐
IALC4/2018
10506.2018
器蹴概:|
P52に~~~~
IRLA File
Lic.No/Date:0310810600 1Defer
118.01.2017 1Date:05.062018
101/82/050/01263/AM17/
84
Export product
Exp.
Qty.
SI.No.
lmport items
Qty. Allowed kg
ALPHA PICOLINIC ACID
l kg
1
2 CYANOPYRIDINE
1.34 kg
17/
1357/
IMcet No/Date:3/82‐
IALC4/2018
‐05.06.2018
1Lic.No/Date:0510401381
125.01.2017
LC4/20
/82¨A
Deferred for comments of TE
| ICase No.:2/1/82¨ ALC4/2017
ParりName:ALKALOIDS
CORPORAT10N
,Meet No/Date:3182- ;Status:Deffered
ALC412018
land Re-indexed
05.06.20 I 8
:%翻嵐i:ふ↓∴
IRLA File
:02/24/040/00216/AM17/
|ソざり認α
02102072873寛ぉ
5Ю620181
No.:113/1/82‐ALC4ノ2017
17/
IPaty NameiCORONA
‐REMEDIES PRIVATE
LIMITED
IMeet No/Datei3/82-
ALC4/2018
05.06.2018
ILic No/Date:0810139606
130.01.2017
|
t
Date:05.06.20 1 8 I
I
I
I
--"-
J
| ICase No。:105/20/82-ALC4/2016 1Paty NamelSAI MIRRA
lNNOPHARM PVT LTD
i l l
|
卜
91恥赫油卜満
Meet No/Date:3/82-
ALC4/2018
‐05.062018
:Lic.No/Date:0410162758
131.01.2017
rStatus: Deffered
and Re-indexed
:Defer l
lDate:0506.20181
ヨ
「
1260
Paty Name:DHANUKA
ILABORATORIES LTD.
:255
|
RLA File
l:05/23/040/00507/AM17/
IStatu∬Deffered
'and Re―
indexed
2571青
O riiも
RLA File
ー
## Case No.:13/1/82‐ ALC4/2017 1ParりNamelMEDICAMEN
BIOTECH LIMITED
.258 ,He iit"
IRLA File
IMcet No/Date:3/82-
ALC4/2018
05.06.2018
霧ぱi蠍:
:01/82/050/01367/AM17/
:UD/Z4/υ 4υ/UUD■
'/AlVi l′
/
iCase No.:95/1/82‐ ALC4/2017
|
IP釘りName:CADlLA
IPHARMACEUTICALS LTD.
Meet No/Date:3/82-
:ALC4/2018
105.06.2018
Status:
Approved
:Lic.No/Date:0810139633
101.02.2017
Decision : Committee considered case as per agenda and deliberated on the mafter in the presence of the technical
'experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as ,
lapplied by firm whichever is lower:
85
Export product
Exp
Qty.
Sl.No.
Import items
Qty. Allowed
PHENOBARBITONE TABLET
30MG
Tablet
1
PHENOBARBITAL
(PHENOBARBITONE)
EP
30.06 mg/per
tablet
| IRA may take appropriate action as perthe decislon ofNorms Committec
|
| ICase No.:105/1/82-ALC4/2017 1ParりName:CADILA Meet No/Date:3/82- Status:Deffered
: .HEALTHCARE LTD ‐ALC4/2018 and Re¨ indexed
105.06.2018 1
2611苦六E:11 ~ II1 1■11 1~… …‐ ~~
■‐■■11,^1111人XlA.ぅ人,lヵ l^:お11 ~ ~
2611。日ぉ ~■
LA nit ・
…… ~
、おヽ6′bttbiib13'644 5も驀:~ ~|
‐ |:01/82/050/01459/AM17/ 1:08/24/040/00451/AM17/ 102.02.2017 Date:05.06.20181
‐ IDecision:DeFerred for comments of TE
ICase No.:10/1/82¨ ALC4/2017 Party Name:JODAS EXPOIM IMcet No/Date:3/82‐ Status:Deffered l
l l lPVT.LTD., IALC4/2018 and Re¨
indexed l
105062018 1 1
263 1lQ Fi18‐ ~ RLA Fil` ~ ltitiヽ
6′bi`:0も164di4念1 1b`fel ~ |
| 101/82/050/01364/AM17/ 1:05/23/040/00521/AM17/ 103.02.2017 Date:0506.20181
IDecision:Deferred for comments of TE
|
‐
tit`ヽ6:111ウ/i,82LALC4/う61ウ||五おヽ五島
`:ё
AbitA ~ ,Mもよヽも
,5ふ&b′jメ
. ‐ IHEALTHCARE LTD :ALC4/2018
Status: Deffered
and Re-indexed
. : IHEALTHCARE LTD :ALC4/2018
1 ′ 1 105.06.2018
0641■ス島一― ――
― -1.:=・
ギ鵠藤蕊ふ廠話; ■協璃
ililill↓∴
ILic.No/Date:0810139654
106.02.2017
‐
|:01/82/050/01471/AM17/ 108/24/040/00452/AM17/ 106.02.2017
1 :Decision:Deferred for comments of TE
1
IDefer
l Date:05.06.2018
|
Parfy Name:ARVEE,
LABORATORIESINDIA
IPRIVATE LIMITED
Meet No/Date:3/82‐
IALC4/2018
105.06.2018
ILic.No/Date:0810139667
107.02.2017
Status:Deffered
and Re-indexed
Defer
Date:05.06.2018
Pa“y Name:CADILA IMcet No/Date:3/82- Status:Deffered l
HEALTHCARE LTD
‐ALC4/2018 and Re― indexed‐
ICase No.:108/1/82¨ALC4/2017 Patty Name:CADILA
HEALTHCARE LTD
Meet No/Date:3/82-
IALC4/2018
105.06.2018
」お1ヽル5:面tibijう64」
IDefer‐ ~
10202.2017
Date:05.06.2018
lStatus:Deffered
land Re-indexed
?ω 轟oA籠…
‐
101/82/050/01462/AM17/
IRLA File
108/24/040/00450/AM17/
′
65 Ⅲoiぉ
101/82/050/01338/AM17/
IRLA Filc
:08/24/040/00315/AM16/
iDecision : Deferred for comments of TE
:661ぃた
RLA File
| :08 124 I 040 I 004 s3 I AM t7 I
IDefer
iDate:05.06.2018
0702.2017
86
一
７
一
％
.Decision : Deferred for comments of TE
: .Case No。:3/20/82‐ ALC4/2016 ParりName:INCHEM Meet No/Date:3/82- Status:Deffered
: | ILABORATORIES PRIVATE IALC4/2018 1and Re‐
indexed
l l lLIMITED 05 06.2018 1
′
681。iぉ― 1良LA nお ILに｀ル醜お
b01oo`465`158fer
l :01/82/050/01180/AM17/ :09/24/040/00497/AM17/ 107.02.2017 1)ate:05.06.2018
1 1Decision:Deferred for comments of TE
ёち品ヽ8わ恵′1'82-ALc4/2biウ 1益,ヽ品よiND」ξWiFi
‐
M88iヽしb嘉
`tた'_
ぶlitiま '
| ILABORATORIES LTD., IALC4/2018 1Approved l
l l 105.06.2018 1 1
■OAi`biたシ636んiムζう
'AMlウ
IRLA n18 ~ 1面し、レ5滸よう
'looi3aj l…
… |
| |:22/24/040/00101/AM17/ .07.02.2017 1 1
ision :-in tn. flgfii"iearlier d;;iil; tut", in *eeting no. 14182 daled24.lO.2Oi, it was decided to ratifu
Decision : In the light of earlier decision taken in meeting no. 14182 dated 24.10.2013, it was decided
norms under Para4.7 of HBP vl as per details given below or as applied by the firm, whichever is less:
Export product
Exoort Otv.
Sl.No.
Import items
Qty. allowed
Clarithromycin Granules
33% (Suspension Grade)
lkg。
1
Clarithromycin or
Raw Material of
Clarithromycin as per
SION 4-2263 on pro-
rata basis
0.3333 kg
2.
Carbopol
0.25 kg
HPMC Phthalate
0.44 kg
4
Acetone
2.00 kg
RA may take appropriate action as per the decision of Norms Committee.
‐Case No.:41/1/82-ALC4/2017
‐
HQ File
l:01/82/050/01395/AM17/
IPa●y Name:GODAVARI
IDRUGS LTD
IMeet No/Date:3/82-
′ALC4/2018
105.06.2018
IRLA File lLic.No/Date:0910064654
109/24/040/00607/AM17/ 10702.2017
|
1269
IFき
｀轟M藤AL磁i亨
1熙鐘
よI:11‐
1麟
甘
魏ダ
'驚
漱i鷺|
1701添海鶏
:j01::1話;~1鷺ち璃
:鳥:::'1話
' ~凛
哺窮計
|。
Si04013憲う
B藷11::ふ18
1 1Decision:Deferred for comments of TE
獅
♭η
ICase No.:121/1/82‐ALC4/2017
HQing一…… ………
|:01/82/050/01475/AM17/
IPaty Name:CLEAN SCIENCE
'AND TECHNOLOGY
IPVT.LTD.
RLA File
:31/83/040/00168/AM17/
Mcet No/Date:3/82‐
.ALC4/2018
105.06.2018
Status:Deffered
rand Re-indexed'
IDecision:Deferred for comments of TE
|
「
―
―
―
「
壺
:
:Case No.:8/6/82-ALC4l20l7 lParty Name:PANACEA BIOTEC ,Meet No/Date:3182- rStatus:
:r,
LTD.,
ALC4l20l8
'APProved
0s.06.20 r 8
't
|
:--'-----
-
,HQ Filg :otl!z{o!!lool78tN}uat8t ,RLA File
⌒
lStatus:Deffered
iand Re-indexed
ILic.No/Date:3110066608 1Defer
102.03.2017 1Date:05.06.2018
87
-W-lrrrs20r?
":`ふ
bi:ё 6■h温さ
`66五
ζ
aもぉ
a tiζも五ζぉも
fttndatta h me prcscnce ofmc"ch面cd cxpc■%l was dectted
10ratittthe ad_hoc input output norms as applied by the Arm under para 4.7 of HBP for one timc basis only and no
repeat licence a1lowed.
IRAmaytよe ttpropH江e adon tt per me decぉbn ofNoms Commhee
.
icase No.:27/6182-ALC4l20l7 ,Party Name:CLEAN SCIENCE ,Meet No/Date:3182- Status:Deffered I
AND TECHNOLOGY
Al.C4l20l8
and Re-indexed
PVT.LTD.
05.06.2018
)1'l
-'" HQ File
RLA File
,Lic.No/Date:3110066777 ,Defer
::0ll82l050l00597lAll4l9l :311831040100035/AMl8/ .09.06.201'7
Date:05.06.2018,
:
| ICase No.:1/6/82¨ALC4/2017
Party Name:DSM SINOCH EM
IMeet No/Date:3/82-
IALC4/2018
|
12
Status:Deffered i
IPHARMACEUTICALS INDIA
PVT LTD. 05.06.2018
741責
。File
‐RLA File Lic.No/Date:2210015738
:01/82/050/00571/AM18/ :22/24/040/00094/AM17/ 12306.2017
lёi`きヽ
bi:49/ι′恵
,lALCIたbiケ
~‐
|五|しヽ
1■も寺
:慧:ё ttЁMiёALSI IM8Ъ iヽ8'5嘉さ
ib′恵
'1~ IStiti::
‐
~:
I PHARMACEUTICALS IALC4/2018 1Approved l
LIMITED 05.06.2018 ‐ |
IHQ File:01/82/050/00619/AM18/ RLA File lLic.No/Date:0310814635 1 1
1 :03/94/040/00260/AM18/ 114.072017 1 :
:Decisbn:Commttteeconsideredcaseasperagendaanddeliberttedonthematterhthepresenceofthetechntall
leXperts and l was decided to ratl″
the ad_hoc input output nolms under para 4,7 ofHBP as per details below or asl
lapplied by nrm whichever is lower
|
Export Product
Qty.
Ｓ
‐
Ｎ
。
Import Item
Qty allowed in
gm
Benzydamine Hydrochloride &
Cetylpyridinium Chloride Anti Inflammatory
and Antiseptic Sugar Free Lozenges
with all Flavours.Each Lozenges contains
Benzydamine Hydrchloride 3.00 mg,
Cetylpyridinium Chloride 1.33 mg, lsomalt
ST-M 2591.86 mg. Net Content
Benzydamine Hydrchloride 87.60 Kgs,
Cetylpyridinium Chloride 38.84 Kgs, Isomalt
ST-M 75682.31 Kes.
1000
Number
1
Benzydamine
Hydrchloride
3.06
つ
４
Cetylpyridinium
Chloride
133
Isomah ST―M
2591.86
Benzydamine Hydrochloride &
Cetylpyridinium Chloride Anti Inflammatory
and Antiseptic Sugar Free Lozenges
with all Flavours.Each Lozenges contains
Benzydamine Hydrchloride 3.00 mg,
Cetylpyridinium Chloride 1.33 mg, Isomalt
ST-M 2591.86 mg. Net Content
Benzydamine Hydrchloride 87.60 Kgs,
Cetylpyridinium Chloride 38.84 Kgs, Isomalt
ST-M 75682.31 Kgs.
1000
Number
4
Benzydamine
Hydrchloride
3.06
Isomalt ST― M
2591.86
Cetylpyridinium Chloride lmg Antiseptic
Sugar Free Lozenges with Mint Flavours.
6
Cetylpyridinium
Chloride
1.00
|
1275
1
―
―
―
―
１
１
１
，１
‐１
嗜
１
硬
１
１
１
１
コ
and Re‐ indexed i
88
Each Lozenge contains Cetylpyridinium
Chloride lmg,Isomalt ST-M 2591.86 mg.
Net Content Cetylpyridinium Chloride 18.25
Kss.Isomalt ST-M 47301.45 Kss.
7
Isomah ST― M
2591.86
ZecufHerbal Cough Lozenges Sugar Free.
Each Lozenge contains Isomalt ST-M
2591.86 mg. Net Content Isomalt ST-M
15243.91 Kes.
Isomalt ST― M
2591.86
RA may take appropriate action as per the decision of Norms Committee.
1 1ヽA lllayしこKc dPPIヽりPI10し。ζ
t。し
1ヽ,1
ICase No.:32/6/82-ALC4/2017
「
黎鮨奮船:∫血
警棚T詢み
1濡濡
:
IHQ File
閉
蔦
/剛″晨mv II悧
郷
α醐
∞翻
61
|:01/82/050/00602/AM18/
IDecision:Committee considered
case as per earlier decision
rl exnerts. it was decided to
taken by NC in its l/82 meeting dated 01.05.2018
ratify the ad-hoc input output norms under para 4.7
1276
I in the presence of the technical experts, it was decided to ratiS the ad-hoc input output norms
HBP as per details below or as applied by firm whichever is lower:
Export product
Exp.
Otv.
Sl.
No.
Import items
Qty. Allowed kg/kg
CARISOPRODOL
kg
1
Propionaldehyde
Liquid
1.024
つ
４
Dimathyl Carbonate
Liquid
0.80
Mono Isopropylamine
Liquid
0.737
4
Para Fonnaldchyde
Solid
0.390
concerned may take futher necessary action as per above decision of NC
ICase No.:2/7/82‐ ALC4/2017
1277
IParりName:DEEPAK
'NOVOCHEM TECHNOLOGIES
iLTD
IMeet No/Date13/82-
IALC4/2018
05.06.2018
stahζ ~1
:Approved l
- 1
IHQ F‖e:01/82/050/00724/AM18/:RLA File
l 131/83/040/00051/AM18/
ILic No/Datei3H0066817
118.07.2017
IDecision:In the light of earlier decision taken by NC in its 2 and it was decided to ratitt the ad_hoc input output
norlns under para 4.7 ofHBP as per details below or as applied by nrm whicheveris lower
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed in MT
2,6 Xylidine
500000
MT
1
2,6 xylenol
700.000 MT
2
Catalyst
Not allow as specific
description not given
|
窮8 4/2017Ⅶ蜃儒j
t
ILic.No/Date:0310814736 1
?l.07.2017 1
| IHQ File:01/82/050/00576/AM18/IRLA File
l:03/95/040/00731/AM15/
89
,Decislon:Committee considered case as per agenda
`deCided to ratitt the ad―
hOC input output norms under
lwhichever is lower:
and and in the presence of the technical experts, it was
## para 4.7 of HBP as per details below or as applied by firm
Export product
Exp.
Qty.
Sl.No.
lmport items
Qty. Allowed in kg
1‐BROMO-3-
CHLOROPROPANE
l kg
1
ALLYL CHORIDE
0.673 kg
う
ι
HYDROBROMIC ACID
48%
1.422 kg
may take appropriate action as per the decision of Norms Committee
| ICase No.:7/6/82-ALC4/2017 :Pa●y Name:NEOGEN Meet No/Date:3/82‐ iStatus:Approved
~
… 1淵
盤ゞ |
|:
貯HEMCALS HMTED
|
| :HQ File lRLA File :Lic.No/Date:0310814813 1
: 101/82/050/00577/AM18/ 103/95/040/00700/AM17/ 125.07.2017 1
1 lDecision:In the light of earlier decision taken by NC in ls 2/82 meeting dated 16.05.2018,it was decided to
l rati～the ad― hOC input output norlns under para 4.7 ofHBP as per details below or as applied by flrln whichever is
279 10Wer:
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed in kg
6¨BROMOHEXYLTRIMETHYL
AMONIUM BROMIDE
(BHTAB)
l kg
1
1,6 HEXANDIOL
1 233 kg
つ
４
HYDROBROMIC ACID
48%
3.53 kg
RA may take
action as
appropnate
per
| ICase No.:40/6/82¨ ALC4/2017 1Party Name:CIPLA LIMITED. 'Meet No/Date:3/82- Status:Deffered l
l l lALC4/2018 and Re¨
indexed l
105.062018 1 1
ギ
器
底泉jttilittj
…
脇
胤
1あ∴1話j :「
濤鸞
ま
“
血14908B諸
11蕊ふ
|
| IDecision:Deferred for comments of TE
l iCase No.:23/6/82‐ ALC4/2017 Pa■y Name:SHARP MINT LTD.:Meet No/Date:3/82-
'
′ :ALC4/2018
、 105.06.2018
1at
-"' Hq File
,RLA File
Lic.No/Date:0510403559
'
',:01182/050/00593/AMl8/ ;05/2404000194/AMl8/ r01.08.2017
.Status: Deffered
,and Re-indexed
,Defer
‐Date:05.06.2018
iDecision : Deferred for comments of TE
」
I Case No.:94/6/82‐ALC4/2017 Par57 Name:KOPRAN 'Meet No/Datci3/82- IStatus:Deffered
l l
‐RISEARCH LABORATORIES IALC4/2018 and Re¨ indexed l
l LTD. 05.06.2018
‐
‐
282 1Ho Fli` ☆LA lile ~1181ヽ
o'biお:6bibttiもblう 15さ籠1 1
1 ::01/82/050/00664/AM18/ 1:03/94/040/00385/AM18/ 104.08.2017 Date:05.06.20181
l Decおlon:Deferred for comments of TE I
Status:Deffered
and Re-indexed
要
蔦翻
「
F
| |
90
1 扁:戸
l協脇蔦葛IttI
ILic.No/Date:0310815033
104.08.2017
IDefer l
lDatc:05.06.20181
,Decision : Deferred for comments of TE
|
ICase No.:136/6/82¨ ALC4/2017
HQ File:01/82/050/00706/AM18/
IMeet No/Date:3/82‐
IALC4/2018
105.06.2018
RLA File lLic.No/Date:0310815082
103/95/040/00240/AM15/ 109.08.2017
Status:
Approved
,Decision : Committee considered case as per agenda and and in the presence of the technical丁
「
experts, l was
ap口たdby im i
l
284
to ratiff the ad-hoc input our
er is lower:
tput norms under para 4.7 of HBP as per details below or as applied
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed in kg
1-BROMO-3-
CHLOROPROPANE
l kg
1
ALLYL CHORIDE
0.673 kg
つ
４
HYDROBROMIC ACID
48%
1.422 kg
,
「
い両面蔵=C42mF獅
稿
雨
画
面百~veetNあ
話3/82-
1 1 1LIMITED rFORMERI′
Y IISV IAl′ C4/2018
i l
l :
|
:LIMITED(FORMERLY USV IALC4/2018
| ICase No.:137/6/82-ALC4/2017 Pa●y Name:P.K. Meet No/Date:3/82- iStatus:Deffered
l l lPHARMATECHPVTLTD IALC4/2018 ,and Re‐
indexed
105.062018 :
2851責。
liiも ~ ~ |ヽLA ri18 ‐‐
Litiヽ6′Dat`:σjibji514b 15もfel
l l:01/82/050/00707/AM18/ .:03/95/040/00036/AM18/ 11.08.2017 1Date:05.06.2018
| :
1 ‐ ILIMITED) 105.06.2018
286 1HQTile~~~~ IRLA File Lic.No/Dat
1 101/82/050/00678/AM18/ 103/95/040/00393/AM18/ 116.08.2017
ILic.No/Date:0310815158 1Defer
16.08.2017 1Date:05.06.2018.
|・υ l′ 04′ υυυ′Vυ υ ′0′ AlVl1 0′ |.υ O/ンυ′υ41υ /υ υDソ,/AlVl1 0/ 110.υ
O.∠U1/
| I Decision:Deferred for comments of TE
―
―
|
ICase No.:111/6/82-ALC4/2017 ParサName:LUPIN LIMITED Meet No/Date:3/82- Status: |
IALC4/2018 1Approved l
l l ,05.06.2018 1 1
「Q7∝∝慇ν
“
OЮ
“
粗晨mν
鵬ら馳υ叩
鳳mγ l悧
辮
α
“
Ю制"%F¬
|
|
1287
Decision : the light oIearlier decision taken in meeting no. l4lS2dated 05.07.201 l. it was decided to ratifli norms
## Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less:
Export Product
Quantity
Sl.No.
lmport items
Quantity allowed
Rifampicin
BP/USP
l kg
1
Sodium Rifa‐ S
0.98 kga
2.
Chloroform
0 661 kg
Acetic Acid
0.16 kg
4.
Piperzine Anhydrous
0.12 kg
Methylene Chloride
0.933 kg
6.
Isopropyl Alcohol
0.51 kg
7.
Dimethyl Formamide
0.75 kg
Tertiary Butyl Amine
0.19 kg
tStatus:Deffered
land Re-indexed
I
91
9.
Acetone
0.832 kg
10.
I -Am ino-4-Methyl Piperazine
0.16 kg
,
RA concemed may take hrther necessary action as per above decision ofNC.
approprl
―
―
―
―
憲
per
Export product
Exp.
Qty.
SI.No.
Import items
Qty. Allowed in kg
VINYL BROMIDE 25%IN THF
l kg
1
HYDROBROMIC ACID
48%
1.232 kg
０
４
TETRAHYDROFURAN
(THF)
0.75 kg
may take appropriate action as per the decision of N,orms Committee
## Case No.: l6l6i82- ALC4l20l7 Partv Name:SUN
||
し89:扁而
― ―
―一―
一―
― IPlビlYll¨lI■i
14υ
ノ
IHQ File
‐ 101/82/050/00586/AM18/
:PHARMACEUTICAL
iIN nHミTpT口QITn
'Meet No/Date:3/82-
1諸″鰍ぜ
Status:Deffered
and Re-indexed
b力3 :圭
:ま::.:蕊: |
:RLA File
:Lic.No/Date:051040
|:05/24/040/00219/AM18/
118.08.2017
¨
―
…… …
… …
…
…
…
…
～～
|
|
| ICase No.:106/6/82-ALC4/2017 1Paty Name:SPAK IMeet No/Dtte:3/82- lstatus:Deffered
■
1器
OCHEM ttЫ →PV■
‐認
鰍f rttk茄
“
Кd
i釧19腺
0鳥花1鳥j
琺
痣:1,話1譜jl話1~~究
需
&萌面
金
"な
it温
視1:
i
iDecision : Deferred for comments of TE
l… 0基もNo:167/6/82:ALC4/201ウ
"五
●面iおよRO'ALI責ARMA… IMeよヽルbi&bたが '
、薇Iふ3ffeitil
l : 1 1ALC4/2018 and Re‐
indexed i
105.06.2018 1 1
,921。■ぉ‐~――‐…一三LAヽお… ‐… …■」よヽ
o/Dttbilo8iちbj'DefeF…
~~|
| 101/82/050/00677/AM18/ :03/95/040/00424/AM18/ 123.08.2017 Dtte:05.06.2018:
| |
‐ ~ ~
‐
― ―
――
、
一
―
‐ _―
―
‐
‐ _一
‐
‐
―
―
―
…
― 一
‐―
ヽ
…
―
―
―
―
―
―
―
―
―
―
― - 1
1 1Decision:Deferred fOr comments of TE I
IP釘7 Name:NEOGEN
ICHEMICALS LIMITED
IMeetNo/Date:3/82-
IALC4/2018
105.06.2018
Status:
)
Approved
HQ Flle:01/82/050/00704/AM18/RLA File
l :03/95/040/01044/AM17/
1悧辮α“Ю制""|
i
rDecision : Committee considered case as per agenda and and in the presence of the technical experts, it was !
decided to ratifu the ad-hoc input output norms under para4.7 of HBP as per details below or as applied by firm
2gg ;whichever is lower:
I
ICase No.:149/6/82-ALC4/2017 Patty Name:THEON
IPHARMACEUTICALS LTD,
,Mcet No/Datei3/82‐
IALC4/2018
105.062018
淵蹴脚
:
′90 HQ File ~~~~~~Sに
ILic.No/Date:2210015752
18.08.2017
:01/82/050/00719/AM18/
IDefer l
lDate:05.06.20181
,Decision : Deferred for comments of TE
92
I Ic:“ ヽこlio9/6/8'―ALC4/26iウ
|が高
ヽ1品:RUSAN IHARMA‐ Mもよヽ6′51ま」
'821~~Statu:b`ffel`j
' 1 1LTD. IALC4/2018 1and Re¨
indexed l
105062018 1 1
′
%:憾
膚11:::凛話j~驚
鳳i鳥腕Ittt~m需
品而お転
‐
B壺蕊
ふ11
IMeet No/Date:3/82- Status:Deffered l
lALC4/2018 and Re― indexed l
105.06.2018 1 1
ILic.No/Date:0310815404 Defer l
28.08.2017 1Date:0506.20181
| IDecision:Deferred for comments of TE
|
iCase No.:112/6/82‐ ALC4/2017 1Palty Name:USV PRIVATE Mcet No/Date:3/82¨ :Status: |
ILIMITED(FORMERLY USV IALC4/2018 1Approved l
:LIMITED) 105.06.2018 1 1
8/ヽRLA File lLic.No/Date:0310815402
1HQ Fiに:01/82/050/00682/AMl
l:03/95/040/00383/AM18/ 28.08.2017
|
Decision : Deferred for comments otTE
| |:03/95/040/00383/AM18/ 128.08.2017 . :
:Decislon:Committee considered case as per agenda and in the presence of the technical experts and it wasl
decided to rati″ the ad_hoc input output norlns under para 4.7 of HBP as per details below or as applied by irlll
,whichevcr is lower: :
1295
ichever is lower:
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed
B市alirudin for lttec」on 250 MG
(Net Content Weight=1.000 Kgs)
4000.000
vial
1
Bivalirudin
1.10 kg
may take appropriate action as pet the decision ofNorms Committee
1~icast Nよ輌た/821ALC4''biウ
ヽごヽ五轟ぎCAI二｀POINT~■
きま｀も
'5品
:j′な
'1
ヽ1ムtiまb`乱たI
I I
ルABORATOttES LTDり
1諸
″ 獄ぜ :nd Re■
ndexedl
′
%HQ F籠~ ~~ヽLAhぎ 話j 協需ま“血“″
・B壺瀧悦漁
:|
| 101/82/050/00600/AM18/ :04/24/040/00HO/Al
l lDecision:Deferred for comments of TE
‐ iCase No。:68/6/82-ALC4/2017 1Pa“ y Name:NECTAR
l l :LIFESCIENCES LIMITED
IALC4/2018
105.062018
′
97■
0118‐ ~
ヽLAhお ~
| |:01/82/050/00638/AM18/ 1:22/24/040/00009/AM18/
1 :Decislon:Deferred for comments of TE
:Lic.No/Date:2210015762
130.08.2017
iCase No.:150/6/82-ALC4/2017 ,Pa●y Name:NECTAR
I ILIFESCIENCES LIMITED
HQ Flle lRLA Flle
:01/82/050/00720/AM18/ ::22/24/040/00032/AM18/
HQ Flle
Meet No/Datei3/82-
ALC4/2018
05.06.2018
ILic No/Date:2210015760
130.08.2017
rStatus: Deffered
and Re-indexed
Defer
,Date:05.06.2018
IDecision:Deferred for comments of TE
ICase No.:123/6/82-ALC4/2017 Party NameiSHREE LIFE
ISCIENCES PVT LTD
1294
4ノ‐
IHQ File
RLA File
:03/95/040/00437/AM18/
lStatus:Deffered
rand Re-indexed
93
IStatus:Deffered
and Re¨ indexed
15もfei… ………
lDate:05.062018
:Decision : Deferred for comments of TE
iCase No.:151/6/82‐ALC4ノ2017 Pa●y Name:NECTAR IMcet No/Datei3/82-
1 lLIFESCIENCES LIMITED :ALC4/2018
‐ 105.06.2018
2991。高お ~IRLA F轟8 ~~~~~~~薔も、も
,Datもうう
166iもケ諦‐
1:01/82/050/00721/AM18/ 122/24/040/000341AM18/ 131.08.2017
面
―
一
〇
No.:83ノ6/82-ALC4/2017
舞Q ΠL
101/82/050/00653/AM18/ :05/23/(
IDecision:Deferred for cOmments of TE
やL●ヽ昴僣1通ζЁ☆
iもS kAЁ i… IMもも
1ヽ6,5滸&j′わ: ~ ヽ
titi:ib`ffeFきa
pNCOLOGYЫ
M「ED I紺
∬鰍f lndRe■
ndexed
lRLA Flle
‐Lic.No/Date:0510403920 1Defer
l:05/23/040/00218/AM18/ 104.09.2017 1Date:05.06.2018
Ё文161M ‐
IMきさ
tヽ6/bふiき:」,82‐ Istatus:Deffered l
l :ё iζきヽ6.:ウ
`/6/8ゴ
:ALむ4/2017 :ParりName:JODAS
land Re‐ indexed‐
‐ ‐ IPVT.LTD :ALC4/2018
‐ .
‐ ' 105.06.2018 1 1
¨ 31ぃ
ぉ
1鍵
ち鵜
λぉ易鳳
…
Lic.No/Date:0510403960 1Defer i
Ⅵ18/ 0709.2017 1Datei05.06.20181
1 1:01/82/050/00646/AM18,
畑1。九 lA品
話j…
事椰
赫面鏑
皇[塩蔦.ふ
|
|:01/82/050/00646/AM18/ 1:05/23/040/00227/Al
lDecision:DeFerred for comments of TE
Pars/Name:JODAS EXPOIM IMcet No/Date:3/82‐ lStatus:Deffered i
PVT LTD IALC4/2018 and Re‐
indexed l
1 105.06.2018 1 1
1RLA Filc ~ ~:titiヽ
6′Datもib`ib46」050 ibきfei~~~ |
,RLA File
;Lic.No/Date:0510403959 lDefer
:051231040/00226lAMl8l 07.Og.2Ol7
'Date:05.06.20 t8
'M品
｀も/Dat&3/8'1~~ |まitiζ:b`ffel``
:ALC4/2018 1nd Re‐ indexed
i0506.2018 1
1Lic.No/Date:0510403934 1Defer
10509.2017 1Date:05.06.2018
|:01/82/050/00649/AM18/
1 103/95/040/00462/AM18/ 107.09.2017 . :
I)ecision:Committee considered the case as per earlier decision taken by NC in its 15/82 dated 12.01.2015 and inl
I COnSuha■。n wlh techdcJ authorly present in mecdng,decdcd to rad～
norlns under para 4.7 of HBP as per
l faseN∝鯰ν
6だ2‐ALC42m7 1鴛柵器轟vT.LTD I造き継階に
3慇2-1聯
hed l
1 1 1 105.06.2018 1 1
305 10Fiお
‐
ibiたシ
63bク6669i′ AMI:ア
i良LA Fli ‐~~… ~~ILi`:ヽも
/D猛&6jibなiζ
`bケ
■ ~ |
## Case No.:143/6/82‐ ALC4/2017 Party Name:SHIVA
IPHARMACHEM LTD
F00絹面市~~~~~~~~~
101/82/050/00713/AM18/
|:34/24/040/00121/AM18/
:Lic.No/Date:3410043429 1Defer
131.08.2017 1)ate:05.06.2018
:Meet No/Date:3/82-
:ALC4/2018
105.06.2018
lStatus:Deffered I
iand Re-indexed i
,Case No.:78/6/82‐ ALC4/2017 ParりName:JUBILANT
IGENERICS LTD
3021山
Q Fii`
RLA File
::01/82/050/00648/AM18/
:Decision : Deferred for comments of TE
1root,-.
94
ils given below or as applied by firm whichever is lower:-
Export product
Exp
Otv.
Sl.No.
Import items
Qty.A1lowed
Kg
ORLISTAT
PELLETS 50%
l kg
1
ORLISTAT
0.505
2
STARLAC(CompOund of Maize
Starch USP/η NF,EP and Lactose
Monohydrate USP/NF,EP)
Does not match with
conffol of Materials
furnished by firm
3
POLYVINYL PYROLIDONE K-30
(PVPK-30)
0.05
iRA concerned may take further necessary action as per above decision of NC.
l iCase No.:72ノ6/82-ALC4/2017
1 :
13061。Tile t … ‐ … …
1 1:01/82/050/00642/AM18/
IPaty Name:STRIDES SHASUN
ILIMITED
RLA File
l:04/24/040/00H2/AM18/
Mcet No/Datei3/82- :Status:Deffered l
:ALC4/2018 and Re‐ indexed l
.05.06.2018 1
1Lic.No/Date:0410163499 1Defer
08.09.2017 1Date:0506.20181
iDecision : Deferred for comments of TE
=~lciINよ
:1,j6/82‐ ALC4/2b17 1Pao｀五品:ヤASiJ~~ IMcet No/b猛よ」′821~… blitiζ btffeLa
l : INDUSTRIES PVT.LTD. ALC4/2018 ,and Re■
ndexed l
l"Loil… ………轟
A Fit… ………Ⅲ躙棚よ
0310H`力「｀語~|
: ::01/82/050/00690/AM18/ 103/95/040/00481/AM18/ 113.09.2017 1Date:05.06.20181
: iDecision:Deferred for comments of TE
1 lCase No.:131/6/82¨ ALC4/2017 1ParりName:YASHO
: I INDUSTRIES PVT.LTD.
3081責。liiぎ~~~ ｀
~ IRLA File
i:01/82/050/00701/AM18/ :03/95/040/00480/AM18/
No.:89/6/82‐ ALC4/2017
IParりNamc:PCL OIL&
ISOLVENTS LTD.
難ち糀
OЮ025VAM ν
Meet No/Date:3/82-
ALC4/2018
05.06.2018
ILic.No/Date:0310815729
113.092017
-1
,Mcet No/Date:3/82‐ :Status: ‐
1諸″鰍f Fpproved l
lLic.No/Date10510404050 1 1
120.09.2017 1 1
y NC in its 2/82 meeting dated 16.05.20181
.7 ofHBP as per details below or as appliedl
,Status: Deffered
and Re-indexed
rDefer
l
Date:05.06.201 8
い
‐
１
一
:HQ File:01/82/050/00659/AM18/
I
309
cision : Committee considered case as per earlier decision taken by NC in its 2182 meeting dated l6.t
I it was decided to ratifu the ad-hoc input output norms under para 4.7 of HBP as per details below or as
firm whichever is lower:
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed
Plasticizer(PVC)
(DINP)
l kg
1
PHTHALIC
ANHYDRIDE
0.372 kg
つ
４
ISO NONYL ALCOHOL
0.726 kg
|
95
:310
ICase No.:90/6/82‐ ALC4/2017 Paty Name:PCL OIL&
1 1SOLVENTS LTD.
:HQ Flle RLA File
i:01/82/050/00660/AM18/ 105/24/040/00259/AM18/
:Decision:Deferred for comments of TE
IMeet No/Datc:3/82-
IALC4/2018
105.06.2018
-!:.or79l_?_
__ ____ _
IALC4/2018
ILic.No/Date:0510404051 iDefer
iStatus:Deffered
land Re-indexed
*:".--...,.
:Datc:05.06.2018
I
.. ] ...'...'''--'--- .--:
'Status:
:
lApproved
',
| IPRIVATE LIMITED,
HQ Fib:01/82/050/00667/AM18/1RLA File
105.06.2018 1 1
1titiヽ。
/Datさbウidii,i倦 =~‐ ~ |
1 1:07厖4/040/00166/AM18/ ,1.09・2017
:
Decision : Committee considered case as per earlier decision taken by NC in its 2/82 meeting dated 16.05.20 l8
,ah,l if .',." A^^iA^A +^ -^+:&, 1l ^ ^,I L^^ :--,,+ ^,,+-,,+ -^*^
,,-i^-
^^-^ i - ^arrDn
^^ -^- l^r^:r^
L^r^--- --- -, -,---r:-:
i
land it was decided to ratifli the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied
:by firm whichever is lower:
31.
ヽo.
Export product
Exp.
Qty.
Sl.No.
Import items
Qty.
allowed in
kg
1
CALCIUM LACTATE GLUCONATE
l kg
1
CALCIUM
GLUCONATE‐ ORAL
GRADE
0.686
2.
CALCIUM
CARBONATE
0.310
LACTIC ACID― ANY
GRADE
0.560
2
FERROUS LACTATE
l kg
1
LACTIC ACID― ANY
GRADE
1.028
MAGNESIUM LACTATE
l kg
1
LACTIC ACID‐ ANY
GRADE
1.19
4
ZINC LACTATE
l kg
1
LACTIC ACID― ANY
GRADE
0.990
5
MAGNESIUM LACTATE
GLUCONATE
l kg
1
LACTIC ACID― ANY
GRADE
0390
つ
４
GLUCONO DELTA
LACTONE
0.766
6
CALCIUM LACTATE
l kg
1
LACTIC ACID― ANY
GRADE
0.95
つ
４
CALCIUM
CARBONATE
0.49
A may take appropriate action as per the decision of Norms Committee.
|
1313
簿O Fil`~~~‐
~~:RLA iお
‐
… …
‐ ~~
■お:Noわ品b81014"恵
i
101/82/050/00657/AM18/ 1:08/24/040/00099/AM18/ 21.09.2017
1Dccision:Dcfcrrcd for commcnts of TE
Meet No/Date:3/82-
IALC4/2018
10506.2018
Status:Deffered i
and Re-lndexed:
IDefer l
l Date:05.06.20181
Status:Deffered
iand Re-indexed
iCase No.:75/6/82‐ ALC4/2017
E喘柵
CSTⅢDES SHASШ IMcet No/Datei3/82-
IALC4/2018
105.06.2018
爆
,Case No.:9716182-ALC4/2017 Parfy Name:GLOBAL CALCIUM Meet No/Date:3182-
96
ダ¶
g品彎α
04101635473鳶ち
5.06.20181
1摯
N轟轟碗メ
A貴あ
“
ウIPaONametAb聡
‐
1需漱炒角が~濡
鷺蹂籠雷
l l l b5.06.2018 1 1
1161需既::λ話11話
j‐
…
1胤ら璃il胤二1晨↓lj~~‐ けおζ認
さb面f4bう043:111::ち
:111
1 DettおIらし
ferlきdお「
`blhttξ
8fit‐ ~~~…
…~~~
―
― ―
― |
1 1
―
″
―
―
―
―
|
| IDecision:Deferred for comments of TE
r
,Case No.:125/6/82 -ALC4l2Ol7 ,Party Name:USV PRIVATE ;Meet No/Date:3182- ,status:Deffered
i
,LtVtttpO (FORMERLY USV ALC4l20l8
and Re-indexed ,
I i
LtMtrED)
05.06.2018
?15
'"
Hq File
:RLA File
tlic.No/Date:0310815872 Defer
,:011821050/00695/AM l8/
:0319510401004601A}/r181 'Zt.Og.ZOtl
Date:05.06.2018
r
,Decision : Deferred for comments of TE
| ::01/82/050/00688/AM18/
ILic No/Date:0310815896
122.09.2017
,Decision : Deferred for comments of TE
．
つ
る
一
３
一
¨
¨
¨
一
Ｍ
ｅ
Ａ
Ｌ
は
## Case No.:ll8/6/82-ALC 4t2ll7 Party Name:METROPOLITAN Meet No/Date:3182- Status:Deffered
I
..
EXIMCHEM PRIVATE LTD. IALC4/20I8
iand RC-iNdCXCd
0s.06.20 I 8
317
## Case No.:12216182-ALC4/2017 Party Name:RELIANCE Meet No/Date:3182- Status:Deffered
I I
INDUSTRIES LTD.
,ALC412018
rand Re-indexed
05.06.2018
3 I 8 ue pit.
RLA Fite
Lic.No/Date:03 108 I 5890 Defer
t:ll1821050100692lAM18l :03195t0401002461AM181 22.09.2017
Date:05.06.2018
Status: Deffered
and Re-indexed
Defer
Date:05.06.20 I 8
| ICase No.:70/6ノ82‐ALC4/2017 Paty NameiCAPLIN POINT
1320 1 LABORATORIES LTD.,
‐Meet No/Datei3/82-
ALC4/2018
105.06.2018
Status: Deffered
and Re-indexed
| ‐
HQ File
IRLA File
1314
iDecision : Deferred for comments of TE
ICase No.:119/6/82‐ALC4/2017 Ptt Name:UPL lMcet No7rDate:3/82- Status:Deffered l
. ILTD.(FORMERLY UNITED :ALC4/2018 and Re¨
indexed l
、 IPHOSPHORUS LTD。) 105.062018 1 1
IHQ File
IRLA File
Lic.No/Date:0310815884 1Defer
12109.2017
IDate:05.06.2018
IHQ File
IRLA File
ヽLic No/Date:0310815895 1Defer
I)ate:05.06.2018
1319学=^ぃ
IHQ File
97
:HQ File
l:01/82/050/00640/AM18/
IRLA File
104/24/040/00128/AM18/
:Lic.No/Date:0410163550 'Defer l
25.09.2017 1Date:05.0620181
―
|
:Decおlon:Deferred for comments of TE
Ｆ
‐
３
２
‐
ICase No.:3/7/82¨ ALC4/2017
i
獅Q Fne~~
Case No。:96/6/82-ALC4/2017
Party Name:CLEAN SCIENCE IMeetNo/Date:3/82-
‐AND TECHNOLOGY IALC4/2018
1PVT.LTD. 05.06.2018
ILic No/Date:3110066880
125.09.2017
Status:Deffered
and Re-indexed
Defer
Date:05.06.2018
m
:01/82/050/00725/AM18/
:31/83/040/00080/AM18/
ParりName:NEOGEN
ICHEMICALS LIMITED
Mcet No/】Datc:3/82¨
'ALC4/2018
105.062018
Status:
'Approved
HQ File:01/82/050/00666/AM18/RLA File
:03/95/040/00403/AM 18/
~理
調評面b8159361~~
322 exper-ts and it was decided to ratifu the ad-hoc input output norms under para 4.7 of HBP as per details below or as
,applied by firm whichever is lower:
Export Product
Qty
SI No.
Import items
Quantity allowed
in Kg
ETHYL-2-
BROMOBUTYRATE
l kg
1
N¨BUTYRIC ACID
0.701 kg
う
乙
LIOUID BROMINE
1.276 kg
tRA concemed may take further necessary action as per above decision of NC
l fI:ごNよ:I‐lξア
`7j,_Aiё
ZたO171島6｀五品橘由k‐ …… M``1ヽ6′5滸
`:挽
,1 1ま:tiまb`ffel`6
1 1 :CHEMICALS PVT.LTD. IALC4/2018 1and Re‐
indexed
105.062018 ‐
132311。Fii` ~ ‐ ~ 1良LA File~ ~ ~~ ■
ti`:ヽルDateibbibtti3うS, 15さ誌: ‐
| 101/82/050/00685/AM18/
:03/95/040/00500/AM18/
126.09.2017
Date:05.06.20181
| "ecおion:Deferred for comments of TE ~~~~
I
## Case No.:ll416/82-ALC4l20l7 :Party Name:NEOGEN
Meet No/Date:3182- 'status:
AI
ITT
'IA
) ,
:CHEMICALS LIMITED
,ALC4l2}tB
Approved
05.06.20 r8
I
IHQ File :01/82l050/00684/AMl8/:RLA File
' li..Nolpate:0jt0815974
, ,,
::031951040100039/AM 18/
27 .09.2011
Decision : Committee considered case as per agenda una A.iiU..uted on the matter in the presence of the technical
I
)experts and it was decided to ratifu the ad-hoc input output norms under para 4.7 of HBP is per details below or as
324 rapplied by firm whichever is lower:
Export Product
Qty.
Sl.No.
Import items
Quantity allowed
in Kg
1,4 DIBROMOBUTANE
l kg
1
TETRAHYDROFURAN
(THF)
0.412 kg
2
HYDROBROMIC ACID
48%
1.929 kg
―
壼
,RA concemed may take further necessary action as per above decision of NC
98
,Case No。:116/6/82‐ALC4/2017 1ParりName:NEOGEN IMcet No/Date:3/82-
| ICHEMICALS LIMITED IALC4/2018
10506.2018
A
IttStatus:
:
lApproved
)
l,ii
:HQ File :01/82l050/00686/AMl 8/ RLA File
ILic.No/Date:0310815979
127.09.2017
:03/95/040/00474/AM18/
,
,Decision : Committee considered case as per agenda and deliberated on the matter in the presence of the technical ,
, - - ,experts and it was decided to rati! the ad-hoc input output norms under para 4.7 of HBP as per details below or as
,25考:I高も孤語稀き
I誌ご品群
:
Export Product
Qty.
Sl.No.
Import items
Quantity allowed
in Kg
1,4 DIBROMOBUTANE
l kg
1
TETRAHYDROFURAN
0.412 kg
つ
４
HYDROBROMIC ACID
48%
1.929 kg
RA concemed may take負■her necessary action as pcr above decision ofNC
IStatus:Deffered l
and Re‐ indexed l
Lic.No/Date:2210015780 1Defer
| ICase No.:152/6/82‐ ALC4/2017 ParりName:SCOTT‐ EDIL
I : IADVANCE RESEARCH LAB
I I IAND EDUCAT10N LTD
13261。高籠
― ~~~‐
IRLだ
Fiお
‐
‐
1 101/82/050/00722/AM18/ 1:22/24/040/00038/AM18/
1 1Decおlon:Deferred for comments of TE
Mect No/Date:3/82-
ALC4/2018
05.06.2018
2709.2017
IDate:05.06.2018
1327
肩
IAND TECHNOLOGY
IPVT.LTD.
RLA File
8/ :31/83/040/00082/AM18/
‐ALC4/2018
105.06.2018
1Lic No/Dtte:3110066885
103 10.2017
Status:Deffered l
and Re¨ indexed l
1 1
1Dcfer l
:Date:05.06.20181
ICase No.:243/12/82-ALC4/2017
1HQ File:01/82/050/01198/AM18/
ParりName:ANUPAM
IRASAYAN(INDIA)LTD
IRLA File
152/24/040/00057/AM18/
IMcet No/Date:3/82-
,ALC4/2018
105.06.2018
:Lic.No/Date:5210042471
128.12.2017
Status:
,Approved
,Decision : Committee considered case as per agenda and in the light of earlier decision taken by NC in its 3/82
I
rmeeting dated 08.05.2014 and in the presence of the technical experts, it was decided to ratifu the ad-hoc input
,
,output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
328,
Export product
Export
Quantity
S.No.
Import items
Quantity
Allowed
2‐AMINO-4-TRIFLUORO METHYL
4 CHLORO DIPHENYL ETHER
l kg
1
3-NITRO-4-CHLORO
BENZOTRIFLUORIDE
1.232 kg
2.
PARA CHLORO
PHENOL
0.803 kg
|
**************
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