DGFT Committee Minutes
Document text
‐■■ヽ “、 Office of Directorate General of Foreign Trade New Delhi
Para 4.7 Decision(DRAFT)
MEETINC NUMBER :16/82-ALC4/2014 MEETING DATE:23012015 But actua‖ y hcld On 27 02 2015 Meeting No 16/82 of 2014-15,to consider the cases/issues under Duty Exemption :棚盟(驚嚇晴品[::路[「管嘉‖ :と駕∫ξζ酬:「響挽B糊宿t:::』翫 ; 露1:雪;∬網1∬i置犠絆 Jrmanshp d SM JJkatt gngL Add DGFT h Room Fo‖owing members were present― Shri Nirmal Kumar,Deputy Director General of Foreign Trade :1131憶用プ品皿冷 13:::朧認錮鳳た J ShH Mahendra Vikram Singh,Foreign Trade Development Omcer The committee went thrOugh the minutes of ea‖ ier NC―‖l meeung No 15/82 scheduled for 12 01 2015 but actua‖ y held on 22 01 2014 and approved the same The fo‖owing cases/issues were discussed and the committee took the decision as mentiOned against each case : 輻 激〒
Case No A-15
s Universal Bio- Diesel Ltd. Meeting No 16/AM15 dated-2702201S FNo 01/82/162/00198/AM15/DESJII Decision: rt was decided to defer the case for tg.og.zors for comrenE oiMinEtry ofie*.id Renewable Energy (MNRE).
Case No B‐ 139
M/s GENER:X CHEMiE O,PVr.LTD, Meeting No 16/AM15 dated-27022015 F No01/82/050/00537/AM06/DES‐ l‖ RLA F No 03/94/040/00571/AM06 Adv Hc No 0310343371 dated 18 08 2005 Decision:ltwa5decidedtodeferthecasefor18.03.2o1@
Case No 3‐ 140
Meeting No 16/AM15 dated-27022015 F.No. 0l /821050/00256/,{M I I /DES- l F.No. 0 I /82/050/0 I 090/4M I I /DES- I RLA's File no. 2412 4 /040/OOOO9 I AM I I Adv. Lic. No. 2410029974 dt27 )O.2Otd
RLA'sF‖ eno 24/24/040/00014/AMll Adv Lic No 2410030871 dt 27 10 2010 Decision : It was decided to defer the case for comments of Petrochemical Division of C■eNo B‐ 141 M/s Yasho lndustries Pvt., Ltd. Meeting No 16/AM 15 dated-27022015 F.No. o1l82loso/o1121/AM13/DES-lll RA No 03/95/040/00735/AM13 Adv Lic No o310718082 dated 24 12 2012 Oecision, lt was decided to defer the case for 18.03.2015 for comments of Department of c&Pc.
Case No B-142
M/s Rohan Expons india Ltd&M/a Mahcsh RaJ Chernicals Ltd Mceting No 16/AM15 datcd-27022015 F No 01/83/162/00654/AM12/DES‐ HI Appeals filed Against order ofthe Jt DGFT,Ahmedabad in pursuance of Order dated 20 01 2010 ofthe Hon'ble High Court of GЧiarat D"cision , It *"r decided to discuss the case in the next NC meetin&
Case No 3 143
M/sヽ4elzer Chemicals P"Ltd Meeung No 16/AM15 dated-27022015 FNo 01/82/050/01571ノAM09′1)ES‐ III FNo 01/82/050/01530/AMl1/DES‐ HI FNo 01/82/050100428/AMl1/DES― IH RLA's File no 31724/040Ю 0284/AM09 RLA's File no 31/24/040/00215/AMll RLA'sF‖ cno 31/24/040/00251/AM10 Lic No 3110037112dt22 01 2009 Lic No 3110046238dt31 122010 Lic No 3110042864dt13042010 Ｖ Ｖ Ｖ ｄ ｄ ｄ Ａ Ａ Ａ Decisioni Committcc considcred thc as pcr agenda and in consultation with technical authoriり present in the meeting it was decided to amend the description of export product as Santrcatヽ4Z3080(BENZAL KONIUM CHLORIDE 80%)inStead of Santreat MZ 3060(BENZAL KONIUM CHLORIDE 60%) without any other change as dcta‖s givcn below: From Export product as applied by the firm Santreat MZ 3060(BENZAL KONIUM CHLORIDE 600/0) _____― 一 Santreat MZ 3080(BENZAL KONIUM CHLORIDE 80%) _ RA may take appropriate action as per the decision of Norms Committee'
Case No B-144
M/s. Sainor Laboratories Pvt.Ltd.. Ltd Meeung No 16/AM15 dated-27022015 File No 01/82/50/528/AM10′lDES― III … Ⅳ脚Ю 団 ハmO/DES IH皿
RAF No 09/24/040/00040/AMll RAF No 09/24/040/00040/AMll Adv Licc No 0910039225 datcd 01 09 2009 Adv Licc No 0910039590 datcd 14 10 2009 Decision: It was decided to defer the case for 18.03.2015 for comments of Department of C&PC.
Case No B-145
M/s. Sainor Laboratories Pvt.Ltd.. Ltd Meeung No 16/AM15 dated-27022015 F No 01/82/050/00350/AMl1/DES■ || RAF No 09/24/040/00040/AMll Adv Lice No 0910042075 datcd 19 05 2010 Decision: It was decided to defer the case for 18 03 2015 for commcnts ofDepartment ofC&PC
Case No 3-146
M s Shiva Pharlna Ltd Meeting No 16/Aヽ115 dated-27022015 FNo 01/82/162/00016/AM13/DES-lH Ｖ Ｖ Ｖ Ｖ ｄ ｄ ｄ ｄ Ａ Ａ Ａ Ａ Lic No 3410025487 dated 30 10 2009 Lic No 3410025693 dated 25 11 2009 Lic No 341002651l dated 03 03 2010 Lic No 3410027522 dated 16 07 2010 Decision: It was decided to defer the case lor 18.03.2015 for comments of Department of C&PC.
Case No B-147
M/s. VDH Organic Pvt. Ltd. Meeing No 16/AM15 dated-27022015 F F F No 01/82/050/01164/AM 13 No 01/82/050/01433/AM 13 No 01/82/050/00287/AM 14 No 01/82/050/00683/AM 14 No 01/82/050/00697/AM 14 F F Ｖ Ｖ Ｖ Ｖ Ｖ ｄ ｄ ｄ ｄ ｄ Ａ Ａ Ａ Ａ Ａ No 0510339719 dated 29 11 2012 No 0510348250 dated 05 03 2013 No 0510357306 dated 17 06 2013 No 0510365900 dated 17 09 2013 No 0510365901 dated 17 09 2013 RA No 05/24/040/00323/AM13 RA No 05/24/040/00450/AM13 RA No 05/24/040/00087/AM14 RA No 05/24/040/00217/AM14 RA No 05/24/040/00218/AM14 Decision: ln the light of written comments received from Department of Chemicals and Petrochemicals vide their u.o No. 14010/53/2014-Ch ll dated oz.o2.zo75, clarified that synonyms of Thymol crystal is 2-lso propyl-s Methyl Phenol and it is also named as 3-Hydroxy-P-cymene. ヽ RA may take appropriate action as per the decision of Norms Commiftee.
Case No 3-148
M/5. DELTA FINOCHEM PW.LTD Mee■ng No 16/AM15 dated-27022015 F.No. OL/82 /oSO/011051/A rvl t4lDES-il 1 RLA F No 03/94/040/00514/AM14 AdⅥ IたNo 0310759628 da… Decisioni Commitee cOnsidered the as per agenda and in cOnsuhadon with urs ds pcr agenqa ano ln consultatton with technical authority present in the meeting it was decided to amend the description of import item at sl. No. I as Triphenyl ehoipirine instead of Tripheny:PhosphOnium Bromide withOut any other changes as details given below: RA may take appropriate action as per the decision ofNorms Committee. TriphenylPhosphonium Bromide Triphenyl Phosphine Rest of Minutes would remain same 槻響1嘘―
日聴耐 臓躙計｀ 61泌 1蘊 「Ⅲ Date: :lt was decided tO rCJect the casc as the nllll has not ftlmishcd infOllllation despite reminders. r It was decided to reject the case as the firm has not fumished information despite reminders. Status: Rejected not fumished information despite ] t糧事翼 :黒蠅T PRIVATE LlMITED 1造:1輝躊α l″82- 23012015 No:32/51/83-ALC1/2011 4
iCase No.:44/20/82-ALC4/2013 4隔 甍雇蕊 =扇 =百 陽λ ttυ00m4AMロ : It was decided to reject the case as the firm has not furnished information despite reminders. 腋謂海 1誡 d 1蹴瓢i』1」““劇db“缶鵬¨eb FLlc:No/Date10210177518 Date: 14052012 18032015 18.03.2015 for comments of Department of Case No.■12/33/82‐ ALC4/2012 Rejected P畿の配 Status: sion :Committee considered the case as per agenda and in consultation with techr )rlty present in the meeting it was decided to ratiry norms under para 4.7 of HBp v1 as ls given below or as applied by the firm, whichever is less: Export product Exp. Qty. SI No lmport items Qty. allowed kg/kg CLEXANE 60MG lNJECT10N 2s (RE―LABELLED&RE‐ PACKED) lkg MINOCYCLINE HYDROCHLORIDE PH EUR 100 The above decision is subject to NOC from Drug Controller General of lndir RA may take appropriate action as per the decision of Norms Committee. {DCGI) No:30/13/82‐ ALC4/2012 Name:HALDIA F‖ e No:18/20/82- F‖ c ´ ０ r :lt was decided to reject the case as the firm has not furnished information despite reminders. Pary NameiSTERICAT IMeet No/Datei1 6/82‐ GUTSTRINGS PVT LTD ALC4/2014 No.:85/31/82‐ALC4/2012 Pa■y Name:SANOFIINDIA NげDate:16/82‐ IHQ FJe tRLA File i:03 /9 5 IUO I OO46s I AMl3 / 23.01.20t5 r : It was decided to reject the case as the firm has not furnished information despite reminders. Approved
~「否画麗需ワ輌面顧 「
ll器島児
5υ∝釧2/AM W~
Meet Noつate:16/82-
ALC4/2014
23012015
Date:
: It was decided to reject the case as the firm has not fumished information despite
reminders.
1器疏50/O103VAMW
3 In the light of written comments received ffom Department of Pharmaceuticals vide their OM
350H/389'014-PI(Norlns)dated 20 01 2015,l was decided to rati″
the nO:‖ ls under Para 4 7 ofHBP
I as per details given below or as applied by the firm, whichever is less:
may take appropriate action as per the decision ofNorms Committee.
P征りName:FORACE
Meet No/Date:16/82‐
POLYMERS(P)LTD
ALC4/2014
,3012015
Decision :lt was decided to reject the case as the firm has not fumished information despite
Party Name:CADILA
HEALTHCARE LTD,
Lic No Datc:0810117317
:08/24/040ノ00257/AM13/
02012013
(S)-(E)-2-t2-t3-(7-chloro-2-
quinolinyl)-ethenylphenyll-3-
hydroxypropyll-phenyll-2-
propanol
Montelukast
Sodium
z-lt-
(Mercaptomethyl)Cyclopropyll
Acetic Acid
## Case No.:151/33/82-
reminders.
No′Date:16/82‐
賓 0
`部
itti
1財臨-.r ci.'"""
Export Product
Export
Quantity
S No
Import Item
ｄ
Ｃ
Ｗ
ｑ
じ
鰤
駄
l kg
1
124
つ
４
Methanol
2325
N,N-Di isopropylethylamine
030
4
Tetrahydrofuran
Acetonitrile
ｎ
ソ
つ
ι
6
040
鱚
peⅢ
HQ Filc RLA Filc
101/82/050/00040/AM14/ :03/95ノ040/00886/AM13/
Lic No/Datc:0310723636
11022013
Decision : It was decided to reject the case as the firm has not furnished information despite
repeated reminders and no comments from DCGI was received.
‐Case No:4/4/82-ALC4/2013 Pa■y Namc:SABERO Meet No/Date■6/82- Status:DeFfered
1 0RCANICS GUJARAT ALC4/2014 and Re―
indexed
l l LIMITED 23 01 2015
13 1HQ File RLA File Lic No/Datc:0310724136 DeFer Datc:
:O1/82ノ050/00045/AM14/ :03/95/040/00880/AM13/ 14022013 18032015
Decision : It was decided to deferred the case for want ofcomments ofDepartment of C&pC.
'
The case was deferred for 1E.03.2015
## Case No.:79ll/82-
Pa() Name:STERICA t
Meer No/Date:16'82- Saatus:Rejected
ALC4/2013
GUTSTRINCS PVT LTD ALC4/2014
23012015
14 HQ F‖ e RLA File Lic No/Datc:0510346353
Defer Date:
:01/82/050/01437/AM13/ :0524/040/00420/AM 13/ 18022013
Decision : It was decided to reiect the case as the firm has not
repeated reminders.
furnished information despite
## Case No.:31/8/82-
ALC4/20:3
Patt NamelMYLAN
LABORATORIES LIMITED
Meet No/Datc:16/82‐ status:ReJected
ALC4′2014
23012015
1Lic No/Date:0910055106 Defer Date:
19022013
151HQ F‖ e
i :01/82/050/00162/AM14/
1)ecision : It was dccided
repcatcd reminders
RLA Fne
:0924/040/00537/AM13/
to reject the case as the firm has not fumished information despite
## Case No.:57/10/82‐
ALC4/2013
Pa●y Namc:BIOLOGICAL E
LTD
Meet No/Date:16/82‐ Status:Deffered
ALC4/2014
and llc-indcxed
23012015 1
IHQ F‖ e
:01/82/050/00240/Aヽ114/
RLA File
109/24/040/00606/AM13/
Lic No/Date:0910055420 Defer Date:
19032013
18032015
Decision : It、vas dccidcd
of BiOtcchnology
## Case No:6/10/82-
ALC4/2013
Party Name:RANBAXY
LA30RATORIES LTD
RLA File
:05/24/040/00480/AM13/
to defer the case lor 18.03.2015 for want of comments of Department
|
Meet No/Date:16/82‐
ALC4/2014
23012015
Lic No/Date:0510350030
22032013
Staius:
Rejected
Defer Date:
Decision : lt was decided to reject the case as the firm has not fumished information
repeated reminders.
dCSpltC
## Case No:33/2/82-
18 ALC4/20i3
1 鵠1獅
7
IHQ File RLA File Lic No/Date:0510350279 Dcfcr Datc:
10!/82/050/01480/AM13/ :05/24/040/00481/AM13/ 26032013
Decision:In the nght Of writcn comments received from Departmcnt of Pharmaceulcals宙
de their OM
No 35011/388/2014‐PI(Nonns)datcd 20 01 2015,it was decided to ral″
thC nOrms under Para 4 7 of HBP
lvl as per details givcn below or as app!ied by the■
rm,whichever is less:
Export Product
Export
Quantity
S No
Import ltem
Q″
A‖owed
kノkg
AliskirenHemifumarate
l kg
1
Tert-Butyl( I S,3S)- l-(2S,4S)-4-
isopropyl-5-oxotetrahydro fu ran-
2-yl)-3-(4-methoxy-3-(3-
methoxy propoxy)benzyl )-4-
methyl pentylcarbamate (AK1 I )
1526
2
3‐amino-2,2‐ dimethyl
proponamidc
061
HQ Filc
Status:
Approved
Defer Date:
101/82/050/00H2/AM14/
## Case No:71/4/82‐
ALC4/2013
Party NamciCHIRAG
ENTERPRISE
IRLA File
l:24/24カ040/00001/AM14ノ
IMeet No/Datc:16/82‐
ALC4/2014
23012015
1Lic No/Date:2410038645
109042013
Decision : ln the light of written comments received from Petrochemical Division of Department of
Chemicals and Petrochemicals vide their U.o No. 46o17lll20o7-Pc- ll dated 29.o5.2ot4, it was decided to
ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is
19 less:
Export product
Exp
Qty
Si No
Import items
Qty. allowed
RECCNERATED
METHYL
ヽ4ETHACRYLATE
MONOMER[PURITY
>99■ペ
l kg
1
ACRYLIC PLASTIC
STRIPS/OFFCUTS/MIX LOT OF
ACRYLIC SHEETS&CUT THEREOF/
ACRYLIC PLASTIC SCRAP(ITC HS
CODE 39205119)
1 63 kg
l iCase No.:120/10/82- Ptt Name:MEHTA APIPVT‐
Meet No/Datc:16/82‐ Status:
ALC4/2013 LTD ALC4/2014 Approved
23012015
HQ Fllc RLA F‖ e Lic No/Datc:0310730905 Defer Date:
| :01/82/050/00303/AMi4/ :03/95/040/00020/AIⅥ
14/ 109042013
?0 1Decision:In thc‖ ght oF writen comments rcccivcd iom Dcpartmcnt of Pharmaceuticals vide the■OM
No 350H/6322013-PIo(Orlns)datcd 20 01 2015,l was decided to ral～
the nOnns undcr Para 4 7 of HBP
vl as per details given below or as applied by the firm. whichever is less:
Export Product
Export
Quantity
S No
Import Item
Qty. Allowcd
ｌ
Ａ
ｈ
」
「
」
ハ
つ
´
## Case No.:43/10/82-
IALC4/2013
HQ File
i01/82/050/00226/AM14/
Paty Name:SRINI
PHARMACEUTICALS LTD,
RLA File
:09/24/040/00017/AM14/
Meet No/Datei1 6/82-
ALC4/2014
23012015
Status:
Rejccted
Lic No/Date:0910055800 1DeFer Date:
19042013 1
Decision :lt was decided to reject the case as the firm has not furnished information despite
repeated reminders.
## Case No:18/7/82-
ALC4/20:4
22 HQ F‖ e
:01ノ82/050/00662/AM15/
Paty Name:VIVIN
ILABORATORIES PRIVATE
LIMITED
RLA File
:09/24/040/00624/AM13/
Meet No Date:16/82- IStatus:DerFered
ALC4/2014 and Re― indexed
23012015
Lic No/Datc:0910055914 Dcrcr Date:
02052013 18032015
Decision : [t was decided to defer the case for 18.03.2015 for comments of Department of
Pharmaceuticals.
## Case No.:6/7/82-ALC4/2014
Pa“y Namc:RA CHEM
PHARMA LIMITED
RLA File
:09/24/040/00043/AM14/
Meet No/Date:16/82‐
ALC42014
23012015
Lic No′ つate:0910055932
03052013
Status: Deffered
and Re-indexed
23 HQ File
:01/82/050/00650/AM15/
Decision l It was decided to defer the case for 18.03.2015 for comments of Department
Pharmaceuticals.
Defcr Date:
18032015
Of
## Case No.:2ノ5/82-ALC4/2013
Pa“y NamaMYLAN
LA30RATORIES LIMITED
24 HQ F‖ e
:01/82/050/00120/Alヽ414/
1)ecision : It was dccided to
rcpcatcd remindcrs
## Case No.:20/7/82-
ALC4/2014
Meet No/Datc:16/82‐
A LC4/2014
23012015
RLA Filc Lic No/Date:0910055979 DeFer Date:
:09/24/040/00023/AM14/ 10052013
rlCCt the case as thc irm has nOt fumlshcd infollllation dcsple
Status:
ReJected
Party Namc:DR REDDYS
LABORATORIES LIMITED
Mcct No/DateJ 6/82- ,Status:Defrered
ALC4/2014 ‐and Re― indexed
23012015
HQ File RLA Filc Lic No/Datc:0910056000‐
Defer Datc:
:01/82/050/00664/AM15/ :09/24/040/00041ノ
AM14/ 15052013 ‐18032015
Decision:In the nght of wntten cOmments received from Department Of Pharmaceu●cals vide their OM
No 35011/456/2014-P{Norms)dated o2 02 2015, itヽVas dccidcd to rcmind thc f11111 lo nurnish thc
following information :
l. Past production vis-d-vis actual consumption ofall important inputs for last three years
duly certified by Central Excise Authorities.
喘
』蜜電■1聖FMAL
КυMAR
R牌隧理.い:器
°モ。高「齢晶1踊L嘉鶴。
25
。Ⅲnふ着te
螂
帯概競
鱚
mi
1.285 kgA/kg
RA may take appropriale action as per the decision ofNorms Committee.
¨凛轟蔦:淵鷲
Clarithromvcin
2. Batch log Sheet and its summarized statement in tabular lorm lor each batch for the
recent 5 baiches in continuity duly certified by Production Head.
3. Inputs to be imported should be indicated by their generic names instead ofusing brand
names or code names.
The case was deferred for 18.03.2015
~匪
面
戸
戸~~臨
需
需P I爾
ぽ
1機~
階屈高薦議烹蔦戸所麓蕊罵
=蔦
薫戸
~語
漉顧戸蒟面而
tDecision : In the light of written comments received from Department of Pharmaceuticals vide their OM
No. 3501 l/486/2014-PI(Norms) dated 04.02.2015, it was decided to ratiry the norms under Para 4.7 of HBP
vl as per details given below or as applied by the firm, whichever is less:
P61 Export Product
Export
Quantity
S No
Import ltem
Qty. Allowed
Orlistat Capsules
120MG
l kg
1
OHistatBulk Drug
122.4 m{120 mg capsule
IRA to calculate the total quantum ofexport and import depending on the total number ofcapsules being
exported.
iRA may take appropriate action as per the decision of Norms Committee.
Status:
Approved
Defer Date:
## Case No.:14/6/82-
ALC4/2014
HQ Filc
:01/82/050/00416/AMi5/
1繭
51面而
I
IALC4/2014
123012015
Status:Deffered
and Re-indexed
Patt Name:GLAND
PHARMA LIMITED
RLA Fnc Lic No/Date:0910056109'Defer Date:
109/24/040/00065/AM14/ 23052013 18032015
Decision : tn the light of written comments received from Department of Pharmaceuticals vide their OM
No. 3so1U75l2014-Pl(Norms) dated 18.02.201s, it was decided to remind the firm to fumish the
following information :
i)
Literature reference about conversion of IUs to weight of various Low Molecular
Weight Heparins i.e. Nadroparin, Enoxaprin and Delteparin sodium.
ii)
Consumption data for all raw materials used in the production of Low Molecular
i
weight Heparin-Delteperin Sodium Injections, duly certified from Central Excise
authorities for the year 2012-13,2013-14 and April to December 2014.
iii)
Copies of batch log sheets for the last 5 consecutive batches for conversion of
-
Heparin Powder into Delteparin sodium indicating the actual consumption of all
raw materials consumed for getting the API used in the Delteparin sodium
.
injections.
liv)
Copies of batch log sheets for last 5 consecutive batches indicating actual
consumption of 16 raw materials applied for import in all applications against
I
export of Low Molecular weight Heparin-Delteparin sodium injections in pre-
I
filled syringes.
The information sought vide item No.2 and 3 above
production in-charge of manufacturing unit of the firm.
may be certified by
The casc was deirred for 18 03 2015
10
ヘ
ハ
「|~
|
「甲¨ 耶鱚
「
1躙…
10056108
Date:
18032015
鰈
咄
函囮
蜃
閻
繹
繹
i)
Literature reference about conversion of IUs to weight of various Low Molecular
Weight Heparins i.e. Nadroparin, Enoxaprin and Delteparin sodium.
Consumption data for all raw materials used in the production of Low Molecular
weightHeparin-Delteperin Sodium Injections, duly certified from Central Excise
authorities for the year 2012 -13,2013-14 and april to December 2014.
Copies of batch log sheets for the last 5 consecutive batches for conversion of
Heparin Powder into Delteparin sodium indicating the actual consumption of all
raw materials consumed for getting the API used in the Delteparin sodium
injections.
Copies of batch log sheets for last 5 consecutive batches indicating actual
consumption of 16 raw materials applied for import in all applications against
export of Low Molecular weight Heparin-Delteparin sodium injections in pre-
filled syringes.
The information sought vide Item No. 2 and 3 above may be certified by
production in-charge of manufacturing unit ofthe firm.
case was deferred for 18.03.2015
iv)
「
E * N*20r7t0l8t - -
iiurty r.lur"cHnec
lMeet No/Date:16/82-
ALC4zOIJ
ENiERPPJSE
iALC4I}OI4
I
i
123.01.201s
Status:
ApproYed
限児
5∽∝∞ム剛7~ 辮辮"Ю""%「面
ived from petrochemica: Division of Department of
111/1/2007-PC― |l dated 06 08 2014,lt was decided to
given below or as app‖ ed by the nrm,whichever is
Export product
Exp
Q″
SI No
lmport items
Qty. allowed
REGENERATED
METHYL
METHACRYLATE
MONOMER
(Pu‖ ″Cqual or
greater than 99%)
l kg
1
BLACK REGENERATED
METHYLヽlETHACRYLATE
MONOMER(Puri″ nOt mOrc than
90%)
1 30 kg
may take appropriate action as per the decision of Norms Committee.
11
Meet
ALC4/20
Ha F'b ==='-trA
Fl"
Etc.NoDare22t00l3s90
t0v82t050/00254tAM14t
":22t24/MQ/000t6tAN|4t
IZA.O5.Z0t:
Decision :In the light of earlier decision taken by NC in itsl4/g2 meeting datea
was decided to ratify norms under para 4.7 of HBp v1 as per details given below
the firm, whichever is less:
No:71ハ0/82‐
1/2013
NameiSCOTT_EDIL
tMACIA LTD,
eet No/Date:16/82‐
´C4/2014
012015
IDefer Date:
122122014, it
or as applied by
Export product
Exp. Qty.
SI No
lmport items
Qty Allowed
kg/kg
Cefalexin Capsule BP 500mg
(each hard gelatin capsule contain:
Cefalexin Monohydrate BP
equivalent to Anhydrous Cefalexin
500mg) packed in 40000 Boxes
Num bers
Cefalexin
Monohydrate IP
500 mg/500
mg capsule
## Case No.:133/14/82-
PなりNameiCALYX
Meet No/Date:16/82‐
CHEMICALS&
ALC42014
PHARMACEUTICALS LTD
23012015
t : It was decided to reject the case as the firm has not fumished information despite
reminders.
y
No:22/12′82-
Mcct No/Datc:16/82‐
ALC4/2014
嗣:演悦棚iメ麒
:脳明IB」富lmttTw
vl as per details given be10w Or as applied by the■
1111,whichever is less
,/Date:16182- lstatus:
Ol4
llpproveO
)rs
I
)ate:09 I 0056355 fOif.r Uate:
)t3
I
u of Pfrun*."r,i.uf, vide their OM
fu the norms under Para 4.7 of HBP
Export Product
Export
Quantity
S No
lmport Item
QけAllowcd
kg/kg
3-IsobuサI Glutanc
Acid[CMH Diacid]
l kg
1
Isovelaraldehyde
06068
2
EthyI
CyanOacctate
07814
Diethyl Malonate
09784
may take appropriate action as per the decision of Norms Comtinee.
13
Namc:INDOFIL
23012015
一
３
４
Lic No/Date:0310738404
DcFer Datc:
18032015
20062013
: It was decided to defer the case for 18.03.2015 for comments of Department
and Petrochemicals.
螂
|
: It was decided to reject the case as the firm has not fumished information despite
reminders.
Pa●りNalncMYLAN
No/Datc:16/82‐
LABO陽ヽTORIES LIヽ41TED
Lic No/Datc:0910056909
125072013 1
Meet No/Date:16/82-
)ecision:ln the nght(
「o 35011/362/2014‐ PIO
l as per details given bel
)f written comments received from Department of Pharmaceuticals vide thett
Iorms) dated 22.01.2015, it was decided to rati$ the norms under Para 4 7 of
ow or as applied by the firm, whichever is less:
Export Product
″
呻
Ｑ
ｕ
ａ
ｎ
ｔ
ｉ
S No
Import ltem
Qty
Allowcd
kg/kg
Milnacipran
Hydrochloride
l kg
l
2‐Oxo‐ 1-Phcnyl‐3-
Oxabicyclo[3,1,0]Hexane
1.99
2
Methylene Dichloride
1575
3
Imidazole
036
4
Methanol
240
Dimethyl Formamide
244
6
Activated Carbon
005
may take appropriate iction '* oe.ion
'* pe. tn. a"cision of Norms Committee'
their OM
7 ofHBP
ガF濡而メ
冨
Party Name:AMI ORGANTCS
Meet No/Date:16/82‐
。Mi増慧
l憎肯
lit『
医面百~~~~
RLA Filc
1器島児
50/00540AM14/ 囲
OЮ∞り晨
M14/
Ю1/82/050/00540/AM14/
No:46/14/82-
臨児期晰劉ハ
m″ 1臨
「
「01/"Ю 50Ю0467/AMl″ ls224/040/00015/AMИ / p0072013 ~
r : It was decided to reject the case as the firm has not furnished information despite
reminders.
1滲…
1腸棚
0/。。lttAM14/ 厚蕊需
而繭面
1邪
鷺511/O16鍬M14/岡
蹴
∽∝Я魔剛″
商
蕊
: It was decided to defer the case for 1g.03.2015 for comments of Departrnent oi
and Petrochemicals.
to reJect the case as the inn has not furnished infonnatiOn despltc
r
i:Rej€cted
b"te
r : It was decided to reject the case as the firm has not furnished info..ution a".pit"
reminders.
I : It was decided to reject the case as the firm tras not ruinist ea i"f;;;;;
[.p,t"
reminders.
No.:116/14/82-
No:53/14/82-
No.:2/12/82-
Name:UNIJULES LIFE
No/Date:16/82‐
LTD
Name:STERILE INDIA
No/Date:16/82-
ATE LIMITED
NameiVIVEK
No/Date:16/82‐
5
1310044274 1Defcr Date:
r : It was decided to reject the case as the r* n^ noin -ir-t"a inro.."tion a"rpit"
reminders.
嶽1714/82- Lr"JYttCVⅣ
EK Mc∝
No/Datα 16/82-
⌒
|
わ'092∝
3
repeated reminders.
: It was decided to reject the case as the firm has not firmished information despite
鱚
Ｆ
‐
Lic No Datc:0910057546
Date:
13092013
18032015
18.03.2015 for comments of Department of
ヽ4eet No′Date:16/82‐
23012015
~甲¨ 珊饉縣1濶…
AM w鵬
危乳
OЮ舵盤/AMW卜
F∬鼎
α
"Ю
∞η
“
浙
53dCdtO r.CCt thc case as thc flllll has not funni■cd hfOl11laJOn desp“
Cese No.:35/15/82-ALC420l3 lnuny r.ramekOnneN lMeer N"/D"r"' t6182. Ftrtrs,
]LIMITED
lALC4t20t4
rApproved
r
lD.ot.zots
I
HQ File
lru-e F[
EbN"/D"t.o3lo14%, [Duf", Dut.,
:0v82t050t00797tAMt4t l:03t94t040/00472tAMta/ ll3.O9.2Ot3
No. 3501l/430/2014-Pl(Norms) dated February 2015, it was decided to ratify the norms under para 4.7 of
HBP vl as per details given below or as applied by the frm, whichever is less:
Export Product
Export
Quantity
S No
lmport ltem
Q″ Allowcd
kノkg
Pregabalin
l kg
l
Isovaleraldehvde
505
2
Diethl,l Malonate
814
Acetyl Chloride
1060
4
Ethyl Cyanoacetate
602
may take appropriate action as per the decision ofNorms
## Case No:21/19/82‐
ALC4/2013
器脇
"Ю"“AM剛
鵬λ棚
OЮ
"∽/AMW I器
辮
Ю3107""5F面
~
: It was decided to reject the case as the firm has not furnished information despite
rem inders.
No.:48/17/82-
NamcNCHEM
No/Datel1 6/82-
No:63/17/82-
Name:DR REDDYS
LABORATORIES PRIVATE IALC4/2014
: It was decided to reject the case as the firm has not furnished information despite
reminders.
No/Date:16/82-
No.:37/17/82-
13
: It was decided to reject the case as the firm has not fumished information despite
reminders.
No.:17/4/82‐
Party Name:NAPROD LIFE Meet No/Date: l6/82-
14
SCIENCES PVT LTD IALC4/2014
23012015
: It was decided to reject the case as the firm has not furnished information despite
reminders.
## Case No.:17/24/82-ALC4/2013 Pa″ Name:EYTAN LABS IMeet No′ つate:16/82-
ALC4/2014
123012015
: It was decided to reject the case as the item of export and import are same and potency
is within range specified.
## Case No.:48/4/82-
Party Name:MANGALAM
ALC4/2014
DRUGS&ORGANICS
LIMITED
:IN the light of earlier decision taken by NC in its l1/82 meeting dated 05 09 2013′
lt was
to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the flrm,
LABORATORIES LIMITED
LABORATORIES LIMITED
is less:
: It was decided to reject the case as the firm has not fumished information despite
NamelMYLAN
No/Date:16/82-
淋
π蕊語T~「商〒繭而
)r Date:
No/Date:16/82‐
霊
Item of Export
Quantty
S,No
Item of lmport
Quantity a‖ owed
kg/kg
AMODIAQUINE
HYDROCHLORIDE
(HCL)
l kg
1
ETHOXY METHYLENE
MALONIC ACID ESTER
(EMME)
°9° レ/
2
PARACETAMOL
055
/
may take appropriate action as per the decision of Norms Committee'
IM82‐
一
５
４
m駅:辮髄ξlttT剛
LTD P3 01 2015
:It、vas dccidcd to re」cct thc case as the fli‖ l has not fllrnished infonlnation despltc
reminders.
## Case No.:3′24/82-
ALC4/2013
Decision : It was decided to defer the case for 18.03.2015 for comments of Department
piotechndogy
Mcet No/Date:16/82-
曜
~1彎lm
一
Ｆ
Ｉ
‐
―
‐
Ｉ
Ｍ
Ｆ
Ｉ
‐
―
―
―
hi蘇1聴義嚢鷹鵬麻
]
ts received from Department of Pharmaceuticals vide
dated 18 02 2015,It Was dCCidcd tO ca‖ from thc 6nll
皿」
1:∽∝η
AMW
器
疏50/O12yAM剛
膨λttυooo引/AMW
「
Iおろ品
_三
二
二
_______一
―
ニ
ー
ー
ー
ー
ー
ー
ー
ー
ー
「
す
―
一
一
一
一
―
Decision:It Was decidcd to rc」ect thC Casc as thC flrllt has nOt f廿
:It was decided to reject the case as the firm has not fumished information desPite
reminders.
ALC42014
23012015
Mcct No/Datel1 6′ 82-
reminders.
|卜Кttm3
P征りNalncMDAS CARE~F花
O No/Dttc lα82-
Lic No/1)ate:0310755504
5
:01/82/050/01202/AM14/
17
⌒
185/Aヽ414/
16/82‐
/
No■73/23/82‐ ALC4/20131高覆雨語画面面高雨面
「
Name:GLAND
V/
consumption data of 16 raw materiars used in manufacturing of Enoxaprin Sodium
Injections pre-firred Swinues dury certrfied uy cent ai E*"ir" erlr,".iry ro r the year 2012-
13.2Ol3-t4 and Apriito Secember 2014.
F;1,.?::,:"r::^|o.111"?Ij,"..:,n,"- ltt.s consecutive. batches for conversion of Heparin
Powder hぬEnoxap」n SOdlm hdc“ n:I語高ふ温錦品I暮l洲ギ襴欝]:
rnnol,市^HF_´
´^“ :_^`L_
■、, ,
● _
consumcdおr ge面ngぬcAR iscdpぬc島。通」I蔦岳III継樵ζ
r^..:_。^rk^`^Li__ 1
´ .
i."0.:?"lli::1.,,:e":T:^,: ?l ri,l r"o,".",,iilLui.r,""l;;ffi;;;.i*r consumption of
r価pO“ h昴ふ
;ii嘉i:lξ ｀
様
tttitド蝸:l器ぶ
::dlHI羅驚fif型」
i夕で
,.__
Sodiumlnjecrions in pre-fi lled syringes.
The information sought vide tt* io.2 and 3 above may be certified by production in-
charge of manufacturing unit ofthe firm.
The case was defened for 1g.03.2015
κ
:ユ:::lthll:tildecided to rttcct the
Re-indexed
case as the firm has not furnished information despite
Meet No/Date:16/82‐
ALC4/2014
23012015
(b)COA ofExport product as pcr shipping Bil1/Purchasc ordcr
case is deferred fOr 18 03 2015
~「癬鶉器 歴
iぽ引“
2
|
R€-indexed
Date:
18032015
: It was decided to defer the case fbr 18 03 2015 fOrc♀mments Of Dcpartment ofc&Pc
1腸鵬OЮ∞6%AM4
125112013
Lic.No/Date:07 I 0099923
|`リ
]
…
枷
Department of Commerce
ud瘤準轟森誡
IⅢ
## Case No.:2El24l82-
ALC4/2013
)rforthereLvantcOnsignmcntOfimpOncd l
:01/82/050/01227/AM14/
## Case No.: I40123182-
information:
No.: l0l/23182-
Name:ACEBRIGHT
No Date:16/82-
PHARMA PVT LTD,
information:
i)
Consumption data of 16 raw materials used in manufacturing of Enoxaprin Sodium
lnjections pre-filled Syringes duly certified by Central Excise Authority for the year 201 2-
13,2013-14 and April to December 2014.
ii)
Copies of batch log sheets for the last 5 consecutive batches for conversion of Heparin
Powder into Enoxaprin Sodium indicating the actual consumption of all raw materials
consumed for getting the API used in the Enoxaprin Sodium injections.
iii)
Copies of batch log sheets for last 5 consecutive batches indicating actual consumption of
16 raw materials applied for import in all applications against export of Enoxaprin
Sodium Injections in pre-filled syringes.
The information sought vide Item No. 2 and 3 above may be certified by production in-
charge ofmanufacturing unit ofthe firm.
The case was deferred for 18.03.2015
Partv Name:PCL OIL &
ヽ4cct No/Datc:16/82-
SOLVENTS LTD,
ALC4′2014
Re-indered
23012015
Lic No/Date10510372321
Date:
29 112013
18032015
: It was decided to defer the case for 18.03.2015 for comments of Department of C&PC.
19
⌒
164
|
|
|
|
: ln the light ofwritten comments receiyed from Department of pharmaceuticals vide their OM
3501 | /l'7 6/2014-PI(Norms) dated 22.01.2015, it was decided to ratilj/ the norms under para 4.7 of
vl as per details given below or as applied by the firm, whichever is less:
Norms for I
Duloxetine hcl
a1lowed for l No.
一
|
―
―
―
―
―
―
―
」
Norms for I kg Duloxetine hcl.
(Qty. in kg/kg)
Benzoyl-L-Tanaric Acid Monohydrate
A (lso Propyl Alcohol)
NoH‖ s a1lowed fOr l No Capsule(0～
in
mg)
Alcohol USP(Ethano1 99 2%)
Spheres NF (Pharm-A)
53333
No.:18/23/82-ALC4/2013 Pary Namc:NAPROD LIFE
SCIENCES PVT LTD
|
ヽ4cet No/Datc:16/82-
‐ALC4/2014
23012015
“
Fllc ~~~~
Ю1/82Ю50/01065/AM14/
‐RLA F‖ c
103/95/040/00712/AM14/
Lic No/Datc:0310760768
05122013
Decision : It was decided
repeated reminders.
to reject the case as the firm has not fumished
ltittllT空|
Par●NamciCHIRAG
ENTERPRISE
IMect No/Datc:16/82-
‐ALC4/2014
蛛
辮
辟麒
66f霊脇r62ン
8年
20
珈
::
隔扇蕊~~~麗
開。∝
n%“7四硫下
24/040/00387/AM14/ lo4 12 2 ,
「齢脱幽…″ 1
置
V/
Decislon:ln the nght Of written comments received from Petrochemical Division of Department of
Chemicals and Petrochemicals vide their u O No 46011/1/2007-PC―
ll dated 06 08 2014,lt was decided to
raufy nOrms under Para 4 7 of HBP vl as per deta‖ s given below or as app“ ed by the nrm,whichever`
1^..
Export product
Exp
Q″
SI No
lmport items
Qty. allowed
REGENERATED
METIIYL
METHACRYLATE
MONOMER
(Purity equal or
greatcr than 99%)
l kg
1
BLACK REGENERATED
METHYL METHACRYLATE
MONOMER(Pu‖ ″ nOt mOrc than
90%)
1 30 kg
take
action as per the decision of Norms Committee.
may
appropriate
//
File
朧鼎
e091∞
"″
7
:09/24/040/00433/AM14ノ
1嗣:R砺1駆器」尉鴻∫‖駐l∬躙IBJttITanl溜lⅧЪli:l熙C訛
lド麟究「脚
11¨ per detams」vcn bcbw oras ap口たd bythe nm,wHchcvcrヽLss
Export Product
Export
Quantity
S No
lmport ltem
Q″ Allowed
kノkg
4-Bromobutyl-
(3,4-Dimethoxy
Benzoate
l kg
1
Veratiric Acid
0.62 /
3
1,4¨Di Bromo
Butanc
080 /
take
action as per the decision of Norms Committee.
appropriate
pcr
168
)ecision:ln thc lght
o 35011/360/2014-PI(ト
l as per deta‖ s given be
of written comments received from Department of Pharmaceuticals vide their
,lorms) dated 22.01.2015, it was decided to ratiry the norms under Para 4 7 of
low or as applied by the firm, whichever is less:
Export Product
Export
Quallti″
S No
Import Item
Q″
A‖ o、vcd
k〃kg
21
No.:47/4/82-
NameiVIS10N DRUGS
LTD
No Date:16/82‐
No.:141/3/82‐
Name:COVALENT
No/Datc:16/82-
23012015
HQ File
ILic No/Date:0910058567
112122013
:O1/82/050/00145/AM15/
:09/24/040/00418/AM14/
may
Cefixime
l kg
1
7-Phenylacetamideo-3 -
Chloromethyl Cephalosporonic
Acid Para Methoxybenzyl
Ester (GCLE)
150
つ
４
Triphenyl Phosphine
082
Act市ated CarbOn
005
4
Dimethyl Formamide
280´
5
Mcthylcne Ch10ride
1000
6
Mica Ester
082
may take appropriate action as per he decision of Norms Committee.
Meet No/Datel1 6/82‐
ALC4つ014
23012015
1器3児50/O105611蕊丁
~
「
麗需
覇而面
「
I r It was decided to reject the case as the firm has not furnished information despite
reminders.
紐臨 諄棚「…
D365/Am″
階淵
m510373佃
r : It was decided to reject the case as the firm has not furnished info.rnntion d*pit"
reminders.
顔謂"
ision:In the‖ ght Of wrinen commcnts received hm Department Of Pharrnaceuticals vide ther oM
35011たlxlρo14-PINOmS)dtted7811 29151lwasdecmedЮ
rati～the nOnlns under Para 4 7 ofHBP
l as per detans given below Or as applied by the r111‖ ,whiChcver is less:
Norfloxacin
3-Chloro-4-Fluro
Benzenamine
Ethoxy Methylene diethyl
malonate
No:9/23/82-ALC4/2013
Namc:NAWAL
3
Toluene
296
4
Dimcthyl Formamidc
121
5
Methanol
353
6
Anhydrous Piperazine
152
RA may take appropriate action as per the decision ofNorms Committee.
Ｆ
Ｉ
Ｌ
ド
に
―
HQ File
101/82/050700015/Aヽ415/
Defer Date:
1803.2015
Decision:It was decided to deferthc case for 18 03 2015 for comments ofDeparment Of
Pharmaceuticals.
― |
陽3鬼50Ю∝
“
AMW I協
棚。Ю
“"ハm″
階ら鼎
α
"Ю“"∝「蔽
面~
OM
HBP
)ecision : In the light of wriften comments received from Departmenl of pharmaceutica
Io. 3501 I /356/2014-PI(Norms) dated 20.01.2015, it was decided to ratiry the norms under
t as per details given below or as applied by the firm, whichever is less:
ls vide their
Para 4 7 ofl
Export Product
け
ｎ
ｔｉ
呻
Ｑ
ｕ
ａ
ｎ
S
No
Import Item
ｄ
ｅ
は
輌
噛
(2R. 5S)-514-Amino-5-fl uoro-2-
oxo-2H-pyrimidin- I -yl-[ 1,3]-
oxathiolane-2-carboxylic acid, 2S-
isopropyl-5R-Methyl- I R-
cyclohexyl ester (FCME)
l kg
1
Glyoxalic Acid
034
2
Cyclohexane
1227
2,5-Dihydroxy-1,4-
diathianc
028
4
5-Flurocytosine
0531
may take appropriate action as per the decision ofNorms Committee-
No:11ん/82‐
Namc:MICRO LABS
No/Datc:16/82-
2015
Name:ALTA
1器3鬼50Ю0286AMly ttλ
刷:υ0079θAM W
Lic No Date:0310763559
27122013
Decision:In the‖ ght of writen comments received iom Deparment Of Phallnaceuticals vide their
No 350H/458泡014-PIいollllS)dated 17 02 2015,it was decided to rati～the nOl‖ =s under Para 4 7 of
vl as per details given bclow or as apphed by the fl‖
11,ヽVhiChever is less:
Export Product
Export
Ouantity
S
No
Import ltem
Qty. Allowed
kslke
Methyl Salicylate
l kg
1
Salicvlic Acid
0955
う
ん
Methanol
0244
RA may take appropriate action as per the decision ofNorms Committee.
## Case No:48/23/82-
ALC4/2013
Re-indexed
%田
疏5∽Ю%AMW ttλ
棚
OЮtt」諦
~匿
ら鼎
Cω Ю%%郎
1器星鷺5υO∞04ハMl,日
危刷:υ00。3νAM14/
Date:
18032015
: It was decided to defer the case for 12.06.2014 for comments of Department of
Meet No/Date:16/82‐
ALC42014
Re-indexed
23012015
Lic No/Date:0910058787
Date:
31 122013
18032015
Decision :lt was decided to call from the firm to fumish Central Excise Data and also Batch Log
Sheet fOr last 5 bttches The casc was dcfcrrcd for 18 03 2015
Meet Noつate:16/82-
LABORATORIES LIMITED iALC4/2014
‐23012015
HQ Filc
~淋
siI而~~判
No/Date:0910058792 ‐
Defer Date:
マ
'''■
・
｀‐ ′｀●''‐
1/82/050Ю 0092/AM 15/ Ю9/24/∝0/00451/AM14/
: It was decided to reject the case as the firm has not furnished information despite
reminders.
Party Name:SAFECON
Mcct No/Date:16/82‐
LIFESCIENCES
ALC4/2014
Re-indexed
123012015
Lic No/Date:6110001120
31 122013
:ln the light of written comments received from Department of Pharmaceuticals vide
OM No 350]1/352/2014-PIいol lllS)dated 22 01 2015,■
was dccidcd to call from the
follovving infollllation:
There are 22 export products. The firm is advised to link each export item with
the relevant DML (Drug Manufacturing Licence)
騨
報
…
Partv Name:EXCEL
Meet No/Date:16/82-
INDUSTRIES LIMITED
## Case No:22/3/82-
ALC4/2014
Partv Name:GLAND
PHARMAしIMITED
:01/82/050/00026/AM15/
## Case No:88/3/82-ALC4/2014
## Case No:2/2/82-ALC4/2014
Master Batch Formula for each export product.
Namc:MYLAN
Detatled working/justincatiOn for the requirement ofeach import icm
Thc casc was dcferred for 18 03.2015
FaseNo■244/3/82‐ ~
Pary NameiSAFECON
LIFESCIENCES
IALC4/2014
:61/24/040/00023/AM14/
IMeetNo/Date■6/82‐
IALC4/2014
P3012015
sion : In the light of written comments received from Department of Pharmaceuticals vide
oM No. 3501 I /3 8+/20 r +-rlg.rormsj a"i"a ig.o r .zo r s, ii was decided to call for copy o&
(Drug MantlfactuHng Licence)from the irm.The case was deferred for 18.032015
:It was dCCided to dcferthe case for 18 03 2015 for comments of Departmcnt ofC&PC
町
|
it"* xo.,fflVA2:
l ALc4t2ot4
I
Decision:In the nght of w五ten comments received from Department of Pha:‖
iaceuticalS Vide thelr OM
No 350H/402ノ2014‐PI(Nol:"s)dated 22 01 2015,l was decided to rati″ the nOrrns under Para 4 7 of HBP
ヽ1¨ per detJヽ」Ven bebw or¨ apメおd by the■●n,WhtheverヽLss
も高百面石面高面証豪誌高蒟訂薦悪孫高面甲Onlls Commlttee
D習
鐵
:
卿
信
29 40gnνbottle of
500ml
LDPE Granules
of relevant
grade
Number
Glucose 5%
Intravenous lnfusion
BP 500ml(4 Export
ltem)
137445型ЪoX Of25
bottlc Of 500ml
ｔ
υ
■
４
Mect NoIDatc 16182 Status:Approved
No:55/23/82-
Name:SATYAJIT
IDecision:Itwasdccidedtodcferthecasefor18632015foro omments of Dcpartment ofC&PC
10764365 1Defer Date:
Export Product
Ｗ
申
Ｏ
ｕ
ａ
ｎ
ｔ
ｉ
S
No
Import ltem
Qty. Allowed
う
ι
Kraft Paper of
relevant
specifications
Pf諸麗胤=糀棚1島Vl鳳I誂潔響ξ
l風卜
1:I棚鑑器蹴究器
興
町
1魃動21浙
曇l墨L里型聾夕
彫棚OЮ餌譴晨И″
脚
辮
¨
""5
1 -―
富髯肥cLi繭脇慨
slril糧lHI:2f■、
■仲摯
,中よ
00"IP…
"じnnКtt detaJs as"rAp"nd破_33 shO宙ng%■
b」:ni:葛
樵
ぼ
●
RequlrementandrecOγ
:γ °
lS°lVCnt ofeach stagc
・Pas,p“、Hll^`:^..、′:^λ _1_
li1lri:lutt°
n宙卜か宙sA:t品蔦烹:品詰tittltsdJyCCrtlfcd"ccnml Exdse
甲
y taやapprop●
,te lobn aS per me ded●On OfNOrms c総
case was deferred for Ig.03.2015.
Meet No/Date: l6lg2.
ALC4/2014
23012015
1腑
0910058839
翻燕繭繭鸞
111妻酢勇漁需
i
als vide thelr
r Para 4 7 0f
I FxnnII pr^",.^.
Export
Quantity
＆
Ｎ
。
ImpOrt ltem
"
A‖Owed
k■kg
PhenOIy)i:。propyl欝linc
l kg
l
ルlCthyl_2-Ch10rO
PropiOnate
0878
0978
う
ん
Para AnasたAHchyde
3
l olucne
0155
ofloxacin lnGidiG
Infusion l00ml
Number
13.125gm/10oml
Bottle
23 45gm/10omI BOttle
## Case No.:180/3/g2-
ALC4/2014
牌腑°ⅥЫ雨面
´
６
つ
‘
exportFroduit-
五
的
Ｏ
ｎ
”
Ｑ
ｕ
ａ
＆
Ｎ
。
Impo.t It m-
qty. altoG?-
l
LDPE Granules
of relevant
grade
2
―
‖ η
鱚
ギ岬
## Case No.:203/3/82-ALC4/2014
Lic No′ Datc:0910058863
08012014
ハ
4
Mcthanol
0408
may take appropriate action as per the decision ofNorms Committee.
Party Name:VINS
Meet No Date:16/82‐
B10PRODUCTS LTD,
ALC4/2014
23012015
/
賓
繹
撫
脚ml¨
醒
0「∝
“
)rate
鷲蕊黒鵜
絆
鵬
耽
50Ю舵
"ハ
Ⅲ
夕 1協
淵
OЮ
“
。ムm″
: It was decided to reject the case as the firm has not furnished information despite
reminders.
田鍛被
lビl鵠温
|
Re-indexed
Lic No/Datc:0410154292
Date:
15012014
18032015
: It was decided to defer the case for 18.03.2015 for comments of Department of
## Case No.:40/4/82-
ALC4/2014
File
Pa●y Name:NEW ALLIANCE
Mcct No/Date:16/82‐
DYE‐CHEM PVT LTD,
ALC4/2014
Re-indexed
23012015
Date:
18032015
: It was decided to defer the case for 18.03.2015 for comments of Department ofC&PC
Pary Namc:PARENTERAL
Mcct No Datc:16/82‐
DRUGS(INDIA)LTD,
ALC4/2014
23012015
116012014
## Case No.:2008/82- leu.ty Nur",WtXrOnO jUeet NolOate: teltl
E;tr.t
ALC4l20l4
LABORATOPJES P LTD ,ALC4l20l4
Approved
]
:x.ot.2ots
] -"
-
HQ File
lRIo til.
-[.r.t"rU"t.Ozroro ao E.f"r D"t.,
:01/82t050t002041AM151 :0'7 /24t040/00333tAMl4l ,08.01.2014
]
Decisioo , rn rn. tigtt oi*rin r, .o,r,r*nts received fr;D.p".r.;;
Ph".."""rri.ulr "id. th.ir oM
No. 3501 l/391/20I4-PI(Norms) dated 28.01.2015, it was decided to ratift the norms under Para 4.7 of HBP
vl as per details given below or as applied by the firm, whichever is less:
Export Product
Export
Quan■け
ゝ
Ｎ
。
Import Item
Qty. Allowed
Vancomycin
Hydrochloride for
injection USP 500mg
Number
1
VancomycinHcl
538.26mgl50Omg vial
may take appropriate action as per the decision ofNorms Committee.
## Case No.:196/3/82-
Meet No/Date:16/82‐
Lic NυDate:0310766431
16012014
Casc No.:202/3/82‐
:01/82/050/00206/AM15/
27
udyog
´
,ecision : In the light of written comments received from Department of Pharmaceuticals vide their OM
lo.35011137412014-PI(Norms) dated 20.01.2015, it was decided to ratifo the norms under Para 4.7 ofHBP
I as per details given below or as applied by the firm, whichever is less:
Export Product
Expo●
Quanti″
Ｓ
、
Import ltem
Qty. Allowed
Sterilized Water for
Injection B.P. 5ml.
Number
Relevant
Polyethylene
Granules
l.89gm/5ml Bottle
may
appropriate action as per the decision ofNorms Committee.
No:103/3/82-
4
Name:BLiSS GVS
Mcct No/Datc:16/82‐
LTD
ALC4つ014
23012015
田
疏
50Ю∝07/AMW ttλ
鵬
OЮO%2晨MW
〉冨
猾fЮ
釧°76■り
%田
3児5υ∝
“
2AM14/
賜
鵬
∽∞96/Am″ 1躙
鼎
α
"Ю
m6“
Date:
18032015
:lt was decided to call fiom the firm following technical details:
l. COA for foreign supplier indicating Potency ofNystatin imported under present A.A
. Detailed calculation ofarriving at the quantity ofAPI applied.
case was deferred for I 8.03.20 I 5.
: It was decided to send a copy ofapplication again to Department of Pharmaceuticals
their comments. The case was deferred for I 8.03.201 5
Mcct No′1)atc:16/82‐
ALC4ノ2014
R€-indexed
23012015
Date:
18032015
:ln the light of written comments received from Depasrtment of Pharmaceuticals vide
OM No 35011/392/2014-PI(Norms)dated 28 01 2015,it was dccidcd to call from the
following information:
(a) % content ofTabersonine in the imported seeds and its 0/o recovery in each step.
(b) Content ofother bye-products in the seeds, their 0Z recovery and value.
(c) Copy oftechnical literature in support of(a) and (b).
(d) Past production of Vinpocetinevis-a-vis Actual consumption of imported seeds for last
3 years duly certified by Central Excise Authorities.
case is deferrcd for 18 03 2015
「にW31駐―
榔】罫昆躙蹄lED階き腑日“2賠蹴器肌
## Case No.:12/21/82-
Casc No:187/3/82-
ALC4/2014
Party Name:ALCHEM
Lic No/Date:0510376990
24012014
LTD
:01/82/050/00191/AM15/
28
P肛りName:CATAPHARMA
CHEMICALS PVT LTD,
用
幌m夕
陽
棚
OЮm 99/AMW I器
鼎
∝引Ю0623"F爾
瓢
腰謂"
:Reply received and sent to Department of Pharmaceuticalsfor their comments. Thecase
dcfcrrcd for 18 03 2015
|
|
197
|
,ecision : In the light of written comments received from Department of Pharmaceuticals vide their
Io. 350 t t/386/2014-PI(Norms) dated 22.01.2015, it was decided to rati$r the norms under Para 4.7 of
I as per details given below or as applied by the firm, whichever is less:
Export Product
け
ｉ
ｔ
ｉ
帥
Ｑ
ｕ
ａ
ｎ
S
No
Import Item
Qty. Allowed
Uroscan-76(Diatrizoate
Sodium and
DiatrizoateMeglumine
Injection USP 760
mg/ml)
Vials
l
Diatrizoic Acid
31.358gm/50m1 vial
may take appropriate action as per the decision ofNorms Committee.
Ｆ
Ｉ
Ｉ
Ｉ
‐
″
‐
‐
‐
‐
‐
118032015
: It was decided to again send a copy of application to Department of Pharmaceuticals.
their comments. The case was deferred for I 8.03.2015.
¨
¨
に
〈
６
IDecislon:It was decided tO dcferthc casc for 18 03 2015 for commcnts of Dcpartmcnt of C&PC
No:223/3/82‐ ALC4/20:4
Name:llNIJULES LIFE
No/Date:16/82-
LTD
Nol)ate:16/82-
Case No.■11/3/82-ALC4/2014
Party Name:SRIAM LABS
PRIVATE LIMITED
躙馳‐師
:01/82/050700115/AM15ノ
:0924/040/005091ヽM14/
:05/24/040700420/AM14/
05022014
Lic No/Date:0910059150
03022014
Meet No/Date:16/82-
ALC42014
Re-indexed
23012015
Lic No/Date10510378413 Dcfcr Datc:
18032015
Meet No/Date11 6/82-
Date:
18032015
: It was decided to defer the case for 18.03.201 5 for comments of Department of
F酬wYA
IRLA nL
I:09/24/040/00548/AM14/
Mcct No′lDate:16/82‐
ALC4/2014
23012015
Lic No/Date:0910059218
07022014
cision : In the light of written comments received from Department of Pharmaceuticals vide their OM
350111356/2014-Pl (Norms) dated 20.01.2015, it was decided to ratiry the norms under Para 4.j of
P vl as per details given below or as applied by the firm, whichever is less:
Export Product
Export
Quantity
＆
Ｎ
。
lmport Item
Qty
Allowed
kg/kg
(2R, 5 S)-5-(4-Amino-5-fl uoro-2-
oxo-2H-pyrimidin- l -yl-[1 ,3]-
oxathiolane-2-carboxylic acid, 2S-
isopropyl-5R-Methyl- I R-
cyclohexyl ester (FCME)
l kg
l
Glyoxalic Acid
034
つ
乙
Cyclohexane
1227
3
2,5-Dihydroxy-1,4-
diathianc
028
4
5-Flurocytosine
0531
may take appropriate action as per the decision ofNo`11lS COmmittcc
No:149/3/82-
4/2014
:01/82/050/00153/AM15/
Party Name:MOREPEN
LABORATORIES LTD,
: It was decided to defer the case for 18.03.201 5 for comments of Department of
## Case No.:150/3/82-
ALC4/2014
Party Name:MACLEODS
PHARMACEUTICALS LTD
ALC42014
23012015
Lic No/Date:0310769509
06022014
## Case No:8/3/82-ALC4/2014
:01/82/050/00012/AM15/
ision : In the light of written comments received llom Department of Pharmaceuticals vide their
350lll3'l2?0l4-Pl (Norms) dated 22.01.2015, it was decided to ratiry the norms under Para 4.
' vl as per details given below or as applied by the firm, whichever is less:
Export Product
Export
QuantiW
ヽ
Ｎ
。
Import Item
(2ty
A‖owcd
30
1g2 HQ File
:01/82/050/00154/AM15/ 103/95/040/00879/AM14/
kg/kg
MoxifloxacinHcl
l kg
l
Pyridine-2,3-dicarboxylic acid
2162
つ
´
I -Cyclopropyl-6,7-difl uoro-
1,4-dihydro-8-methoxy-4-
oxo-3 -quinolinecarboxylic
acid ethyl ester
ision : In the light of written comments receiyed from Department of Pharmaceuticals vide their (
3501I/398/20l4-Pl(Norms) dated 28.01.2015, it was decided ro ratiry the norms under para 4.7
vl as per details given below or as applied by the firm, whichever is less:
Export Product
Export
Quantity
S No
Import Item
Qty
A1lowed
kノkg
(Amlo―V)2-[(2-
Amino―Ethoxy)
mcthyI〕4-(2-
Chiorophcnyl)-6
Mcthyl l‐ 4-
Dihydro― Pyridinc―
3,5-DicarbOxylic
Acid
l kg
l
Ethyl 4-Chloro Aceto Acetate
0993
2
Ortho ChioroBcnzaldehydc
0775
3
Mono Ethanol Amine
0356
4
Methanol
051
5
Acctic Acid
430
6
Isopropyl Alcohol
230
may take appropriate action as per the decision ofNorms Committee.
―
|■m2∝5
1蹴辮Ю
%∞
"η
2
:09/24/040/00551ノAM14/
ision : In trre riglt oiwrinen corr*.rt, ,...ir"d to, o.punr"nr oi elu-u..rii.ut, ula. ,f,"i, i
35011/37112014-Pl (Norms) dated 22.01.2015, it was decided to ratiry the norms under para 4.7
'vl as per details given below or as applied by the firm, whichever is less:
Export Product
■
的
師
Ｑ
ｕ
ａ
ｎ
S No
lmport Item
Q″
A‖owed
kノkg
Phtha‖midO
Arnlodipinc
l kg
1
Ethyl-4-Chloro Aceto Acetate
0758
つ
４
Ortho ChloroBenzaldehyde
0592
¬,F呵やコWDepamonto「Ccm m●rce
ud課1醐野ミ露
=こ
い
No.:10/3/82-
Name:ARENE LIFE
NCES LIMITED
Meet No/Date:16/82‐
ALC4/2014
23012015
lStatus:
lApproved
I
¨
Ｆ
15/
RLA File
:097724/040/00534/AM14/
lLic.No/Date:09 I 0059227
o'1.02.2014
IDeFerDate:
И
104
Mono Ethanol Amine
0272
4
Methanol
0156
5
Acetic Acid
3535
was also decided to revise SION A-2614 which can be withdrawn and fiesh Productiot
rnsumption data duly certified by Central Excise Authorities may be called from Industr
ough Pharmexil.
\ may take appropriate action as per the decision of Norms Committee.
1‐
y
Pary Name:KREATIVE
ORGANICS(P)LTD,
## Case No.:21/4/82-
ALC4/2014
ision:In the light(
35011/444/2014-PI(1
'vl as per deta■s givl
)f written comments received from Department of Pharmaceuticals vide their
,{orms) dated 06.02.2015, it was decided to ratiry the norms under Para 4.
en below or as applied by the firm, whichever is less:
Export Product
Export
Quantity
S No
Import Item
∞
A‖owcd
kA/kA
GLIPIZIDE
l kg
1
5-MethyI Pyrazine‐ 2-Carboxylic
Acid
044
2
4-2-Amino Ethyl Benzene
Sulfonamide
064
3
Cyclohexyllsocyanate
097
Status:
ApproYed
lslon:In the light of writen comments rcccived iom Dcpament of Pharmaceulcals宙
de their OM
350H/379742014-PI(Nollns)datcd 22 01 2015,it was decided to rati～
the n。111ls under Para 4 7 of
'vl as per detals given belo、v or as app:ied by the il‖
1,、vhichever is lcss:
Export Product
Export
Ouantity
S No
Import ltem
Qty. Allowed
ks.As
Line l(D-3-(3‐
Fluoro‐4
MOrphOlinOphenyl)
l kg
1
3,4-Difl uoronitrobenzene
100
Sodium Carbonate
080
5-(Hydroxymethyl)
Oxazolidin-2-One
Ammonium Chloride
Solution
1324
4
Sodium Bi-carbonate
090
つ
Ｄ
Lithium Tcrt― Butoxidc
10298
6
Dimethyl Formamide
085
7
Tetra Hydro Furan
170
Methanol
0785
9
n-Hexane
574
10
R-Glycidyl butyrate
0964
## Case No:166/3′ 82-
ALC4′ 2014
|
1鷺λ馳OЮ
"16/AM剛
Meet No′Date:16/82‐
ALC4/2014
‐23012015
ision:In thc‖ 鰤t of WTiten comments received hm Department ofPharlnaceuticals vide thei OM
35011/355/2014-PI(Nolnls)dated 28 01 2015,it was decided to rati″
the nO:‖ Is under Para 4 7 of
HBP vl as per details given below or as applied by the firm, whichever is less:
108
IRA may take appropnate actlon as pcrthe dedsbn ofNorms Commlttee
Export Product
Export
Quantity
S No
Import Item
Qty A‖owcd
kノkg
N-Methyl
Benzothiazene
Methyl Ester
l kg
Sodium Saccarinc BP7711SP/1P
129 ´
つ
０
Dimethyl Formamide
050 ´
3
Sodium Mctal
0337
4
Methyl Alcohol
1 55
5
Acetone
0645
6
Xvlene
0645
7
Methyl Chloro Acetate
098
―
|
ision:In thc light of wTitten comments rcceivcd iom Department of Pharrnaceuticals vide thcir OM
3501!/3942014-PI(Nonns)dated 28 01 2015,it was decided lo rati～
the nOl‖ ls undcr Para 4 7 of
'vl as per details given be:ow or as applied by the frm,ヽ
vhiChever is less:
Export Product
Export
Ouantiw
S No
lmport ltem
QけAlowed
kノkg
Finasteride
l kg
l
3-Oxo-4-Aza-5-AlPha-
Androstane- l7-Beta
Carboxylic Acid
190
ヨ
劃
―
コ
33
l
~lm柵
oHETEЮ LABS鰤
:燃Fα
"~1聯
led
l麒0"5ハm`「¬認赳
「
面
2
Di Isopropyl Ether
1017
3
Bis(Trimethylsilyl)-
TrifluoroAcetamide
147
4
2,3-Dich loro-5,6-Dicyano
Benzoquinone
086
may take appropriate action;s p;ll lc decls!On ot Norms Committee.
## case No.:86/3/E2-At cmoll lrarryffi
Noaer,-M; Nr/Datel6/s1
ALC4/2014
23012015
m剛掲
"畑"α
A剛シ
「ぉ
eN∝34/4/82A面而「
Lic No′ 1)ate:0210200380
Date:
21o22014
18032015
:It was decided tO defcrthc case fOr 18 03 2015 for comments Of Dcpanmcnt Of
:,:^.1.
appropriate
as per the decision of Nor.s Coilmitt"".
Meet No′つatc:16/82‐
Re-indexed
Re-indexed
Re-indexed
豆
on:Iwasdeddedosendi∫W
COmments and dcfened thc c`
:02,4Ю40/Oo197/AM14/
## Case No.:132/3/82-
ALC4/2014
Pafty Name:VENUS
REMEDIES LTD,
ALC4/72014
123012015
F雰‖昴守
T∫肌∬
::冊嚇vt柵淵『¶i蒻
rlslo■:In the‖ ght Ofw‖
“
en c。
吉:曇習鰺暮穐
:攪認」
T魚
"口た
dby heim,wnche“ r、たs
Export Product
“
”
師
Ｑ
ｕ
ａ
ｎ
＆
Ｎ
。
Import Item
Qty Allowed
Vincristine Sulphate
Injection USP
Number
l
Vincristine Sulphate
1 10mg/1ml宙al
And
2 20mg/2ml宙al
may take apDroDriate acr'on
: lt,w"as decided to d"f", th" ""." foil g.03 20l5 fo. ".rr*t, .f D"p"rtr"rt "f
No′つate:16/82-
Ｎ
Ｄ
Ｅ
Ｔ
No/Date:16/82‐
Filc
ll“
## Case No.:33/6/82-
Party Name:INDOCO
eet No/Date:16ノ82‐
ALC4/2014
REヽ4EDIES LIMITED
ALC4/2014
123012015
鱚
扇
「
~鱚
I B息閻螂
IDecision:in the‖ ght of writen comments rcccivcd frOm Departmenl of Phal‖ laceuticals宙de the■OM
No 350H 7460/2014‐ PI(Nol“ ls)datCd 02 02 2015,l was decided to can from the nrm a cOpy oF vahd Drug
IManufacturing Liccnce(DML)for bOth Ofthe cxport products The case was defered for 18 03 2015
Re-indexed
18032015
Decision : It was decided to send a copy ofapplication to Department of Pharmaceuticals for
their comments and deferred the case for I 8.03.2015.
CIS10n:In the light of written comments received,om Dcpartment Of Pharlnaceuticals vide their(
350H/51872014‐ PIoomS)dated 20 02 2015,it was decided to rati～
thC n011lls under Para 4 7
P vl as per details given below or as applicd by the illll,、vhichever is less:
Export Product
Export
Quantity
Ｓ
、
Import ltem
Qty. Allowed
LATANOPROST
OPHTHALMIC
SOLUT10N
Number
l
LATANOPROST
Bulk drug
0.1275 mg per 2.5 ml bottle
霊鵬ω
~甲
繭謳
隔雰P面
82‐
町
器3児50ЮttAⅢ夕
~隔
λ棚餅∝Ю4A剛″
~囲
齋
戸
而4050嘔
》辮鬼お服I雪話器
el謂躙
":譜
T瀞冬
冨鱚
∫鴇rTI器
HBP vl as per deta‖ s given below or as applたd bythe nln,whtheverヽLss
Export Product
Export
Quantity
＆
、
Import lter.n
Qty. Allowed
CIPROFiBRATE TABLETS 100
MC
Number
l
CIPROFIBRATE
102 mg per tablet
may
approprlate
as per the decision of Norms Comminee.
Ｅ
Ｊ
，
０
bl器3児50Ю餌
3αAⅢy ttλ鵬
OЮ
"7ν
Am″
No:34ノ6/82-ALC4/2014
Namc:INDOCO
No.:30/3/82-ALC4/2014
Namc:BELCO
No/Date:16ノ82‐
## Case No.: I t/9/82-
ALC4/20
Party Name:SMILAX
LABORA
』
¨
／
８
２
．
一
¨
maceuticals vide their OM
norms under Para 4.7 of
Export Product
Export
QuantiW
S No
lmport Item
Qty AIlowed
,α ′υ_
3‐IsobutyI Glutaric
Acid[CMH
Diacid]
l kg
l
Isovelaraldehydi
`｀8'｀6
06068
2
Ethyl Cyanoacetate
07814
3
Diethyl MalonaG
09784
may take appropriate acGniiJEi-r tlrIC dCClslon ot Norms Committee.
C{seNo.:56/4/82-AtClnOrlie-rry-i{-am-erND{U;rFi
柁
01鵬鷺
5∽“
"ハmy廠蕊
Re-indexed
Re-indexed
Re-indexed
温‰
:朧
]
祠撫舗
:ItwasdecldcdtOdefcrthecasefori8532015forcOmmentsOfDepaltmentof
l■:..:.
## Case No.:5?/4/82-ALC4/20t 4 El.,lame,rND{WlFi-
LABORATORIES LTD.,
--IRLAFil"=_*_=--- r*;r;
ts/
!:22/24t040t00t00/AMt4/ l+.oz.zoli
HQ File
nマHC RLA RL ~~臨
蒸商品め210o14694
:01/82/050/Oo306/AM15/ L22/24′ 040/00inn′ △、ィ:′ ′
: ltaw"as decided to defer the case f;al 8J3.201 5 f".;;r.""t.
"f D"prrtrrt ;
No.:58i4l82-ALC4/20t4 pany Name:tND_SWIFT
Meet No/Date;16/82-
LA30RATOttES LTD,
ALC42o14
23012015
Meet No′Date:16/82-
Meet No/Date:16/82‐
Meet No/Datel1 6/82-
ALC42o14
23012015
LTD,
Re-indexed
NO:42/4/82-ALC4/2014
Name:RECKITT
:It was decldedおdeferthc case fOr 18 03 2015 for cOmments Of Departlncn澤
1,irniO
INDIA
## Case No.:43/24/82-
ALC4/2013
‘
ヽ
~「Mi蘊1‐DI鰈
16/82
″3鵬
3鬼5∽睦
晨M脚
陽ら盤
l1/cD9"ムm″
1悧辮
Ю31077η 3
Decision : It was decided to reject the case as the firm has not fumished information despite
reminders
1濶…
隔ち鵬
υO“翻AMW
悧
開
°
“
Ю
"2“
2
decided to defer the case for 18.03.20[5 for comments of Department of
1躙…
田
3児5υOm 7ハmシ
陽λ鵬
剛
“
9AMw l器
鼎
α∞Ю η
""
Decision:in the light of wTitten comments received hm Department of Pharrnaceuticals vidc ther oM
INo 350Hた30/201牛PloNollls)dated February 2015,it was decided to rati～
the nOmns under Para 4 7
HBP vl as per details given below or as applied by the firm, whichever is less:
Export Product
Export
Quantitv
S No
Import ltem
Qty Allowcd
kノkg
Pregabalin
l kg
1
lsovaleraldehvde
505
2
Diethyl Malonate
814
3
Acetyl Chloride
1060
4
Ethyl Cyanoacetate
602
may take appropriate action as per the decision ofNorms Committee.
Re-indexed
:18032015
24器
星泥50Ю052夕AMIS/
Pharmaceuticals.
う
４
一
Ｍ
Ｊ
一
〇
７
## Case No.:124/6/82-
ALC4/2014
肥
## Case No:116/6/82-
ALC4/2014
:01/82/050/00518/AM15/
isioll:in thc light ofw■
350H/5262014-PIいom
'vl as per details given b(
'itten comments received fiom Department of Pharmaceuticals vide their (
rs) dated 25.02.2015, it was decided to ratiry the norms under Para 4.7
:low or as applied by the firm, whichever is less:
Export Product
Export
Quantity
＆
、
lmport Item
Qty. Allowed
37
WacrF6●icclons h 5ML
vials
l kg
1
Polyethylene Cranules
1 89 gln/5 mi vials
RA may take approDriate actio)n as per the decision of N;;dc;;ittee.
## Case No.:12716/82-
ALC4/2014
Party Name:CATApHA IiMA
CHEMICALS PvT LTD,
Mect No/つate:16/82‐
ALC4/72014
23012015
:01/82t050100529tAM15/ i,
Lic.No/Date:3 I 100633 D
: Itrw"as decided to a.f., th" ."." to, @
Mcet NO/Date:16/82-
Meet No/Date:16/82-
ALC4つ014
23012015
|
…
their oM
ra 4 7 of
Production-
rm Industry
No.:35/6/82-
apprOpriate actiOn as pcr the decisiOn OfNo:1lls Commitee
## Case No.:83/5/82-
ALC4/2014
LABORATORIES PRIVATE
LIMITED
:01/82/050/Oo400/AMi5/
IsЮ n Jn thellght Ofw‖ tteni:脳″
:,』;1lVi111嗜壷iif
llent Of Phall‖ aceuticals vide th(
35011/481/2014-PI(Nonns)da
to radfy the nOn ns ullder Para
'vl as per details given be10w Or as applied by the frm,whichever is lcss:
ExpO■PrOduct
け
■
●
い
Ｑ
ｕ
ａ
ｎ
＆
Ｎ
。
Import Item
Qty
A‖Owed
kttkg
1瀦夕犠11理鵠鵬彙
~
l kg
l
０
ｈ
Ａ
‐
ｐ
ｈ
ａ
枷
0783
2
Ю
０
ｈ
Ｄ
ｉ
ｎ
ｅ
ｍ
Ｂ
ｅ
ｎ
ｚ
ｃ
0966
3
Methanol
080
4
Tolune
0545
was also decided to revise SION ,{_2614 which can be withdrawn and fresh pr
rnsumption data duly certified by Central Excise ertf,"riti".'ruy be called from
ough Pharmexil.
\ may take aDDroDriate action ^s ncr rhp .tA^i":^- ^.rr^--
14
[饉
:鋸%ALS LTD歴
:淵・
貯
"‐
File
Filc
1/83/040/00232/AM14/
Name:VEGESNA
iSiOn:Repけ∝cdved frOm me■m and sentto Depanmcnt Of Phann¨ eu●cJs・
ttli[1111遣
dcferred fOr 18 03 2015
ision : ln the light of wrinen comments receivcd from Depanment of Pharmac€uticals vide their (
35011146712014-Pl (Norms) dated 02.02.2015, it was decided to ratiry the norms under Para 4.7
'vl as per details given below or as applied by the firm, whichever is less:
Export Product
Ｗ
ｉ
ｔ
ｌ
い
Ｑ
ｕ
ａ
ｎ
S
No
Import Item
Qty. Allowed
Prednisol Solution for
Injection 30mg/l ml vial
Packs
1
PREDNISOLONE
SOLUT10N PHOSPHATE
BP
40 348 rng for l ml
vial
may take appropriate action as per the decision ofNorms Committee.
No.:50/6/82-ALC4/2014 Party Name:v& V PHARMA
INDUSTRIES
~l:li11:il::EET「
こ
Й J】
[~~~~
Deffered
Re-indexed
鍮
一
鵬
Ｆ
‐
‐
‐
３
３
‐
‐
B2階厩蕊扇而¬ 1蹴鼎αω
Юηθω躊180■劉
5
Name:ADISHANK
lCALS PVT LTD
File
the case for 18.03
Ｆ
隔
馘
融
孔
回
出
凱
一
爛
咄
一
い
甲¨ 甲囮FI躙…
器
疏5∽
“
男ハmy l糀
糀
oЮ餌二/AM剛 1淵
器
e°71m"“ OFtrDao~
ln the light of written comments received from Department of Chemicals and
ョls vide their u O No 14010/53/2014-Ch ll dated 02 02 2015, it was decided to
ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm,
一
一
・２
０
‐
‐
呻
珈
一
”
﹈
一
け
,■劇2劇5
39
: It was decided to defer the case for I 8.03.201 5 for comments of Department of
Re-indexed
Ｌ
¨
Export product
Exp Qty
SI No
lmport items
Qty. allowed
BENZOYL PEROXIDE
POWDER MAGIC
WIⅡTENER 27 PERCENT
MAGIC WHITENER 32
PERCENT,MAGIC
WHITENER 34 PERCENT
l kg
1
DI BENZOYL
PEROXIDE
75 PERCENT,
(ASSAY 70 T0 77
PERCENT,
MOISTURE
CONTENT MORE
THAN 20 PERCENT)
0 417kg
/
## Case No.:183/6/82-
ALC4/2014
Pa●y Name:TIDE
NDUSTRIES
Meet No′Date:16/82‐
ALC4/2014
Re-indexed
123012015
B51卵
掲5∽
“ “
¨
障角鵬
OЮ∞
“
晨my l
1滲…
Lic No/Date:3410039854 1Defer
:It was decided tO defcrthe case for 18 03 2015 for comments Of Department Of
28042014
Lic.No/Dare:09 I 0059887 lDefer Daie;
## Case No:51/10/82-
: ln the ‖ght Of written comments received from Department of chemicals and
icals vide their u o No 14010/138/2011-Ch il dated 12 12 2014′
lt was decided to
ratifo norms under para 4.7 0f HBp vl as per detairs given berow or as appried by the firm,
whichever is less:
lmport items
DANTUFF‐ C
CLIヽ偲AZOLE)
CHLORO ETHER KETOhIE or
(l,CHLORO,4-
CHLOROPHENOXY 3,3-
DIMETHYL 2-BUT
40
No:237/6/82-
Name:ESTEEM
No/Date:16/82-
5t
l:l7 t24tM0/00002/AM l5l
:It was decided tO dcferthe casc fOr 18 03 2015 for commcnts OfI)epartmcnt of
∬
ド
蘭J"札
Cttm4甲
柵
艦
lttD理
聴戸
而
‐ 「譜蹴
留
P301'
田
島児5υ∞Ю
“
扁
「
~障
ち鵬
OЮ0036/Am夕 1悧
辮
Ю釧∞ω ∞6Btt18“
2∝5
Decision : It was decided to defer the case for I 8.03.20 | 5 for comments of Department of
Pharmaceuticals.
1躙…
Re-indexed
Re-indexed
Decision : It was decided to defer the case for 18.03.2015 for comments of Department of
C&PC.
一
‐
４
‐
## Case No:236/6/82‐
ALC4/2014
## Case No.:238/6/82-
ALC4/2014
Par"Name:GLENMARK
GENERICS LIMITED
Ｆ
Ｉ
い
―
―
|
Meet No/Datc:16/82‐
Status:
ALC4泡014
Approved
23012015
: in the light of written comments received from Department of Pharmaceuticals
,9
:01/82/050/00750/AM 157
Lic No/Date:031078379
:03測
4
41
No.:88/6/82-ALC4/2014
Name:UPL
No/Date:16/82-
1器3児50Ю064餅AMⅣ
卜角棚
OЮ0008AMW
LTD
Name:ESTEEM
No/Date:16/82-
PVT LTD,
Re-indexed
5
Fllc
1710005806
7/24ノ040/00007/AM15/
1710005810
Y UNITED
Filc
: It was decided to defer the case for 18.03.2015 for comments of Department
No:223/6/82-
Name:ANUH
Decisioll:It was decided to deferthe case for 18 03 2015 for commcnts of Dcpartmcnt of
their oM No.35}tL/44812014-pt(Norms) dated 28.01.2015, it was decided to rat
rr Para 4.7 of HBP v1 as per details given below or as applied by the firm, whicheve
ort Product Verapamil Hcl ER Tab USP
ify norms
rr is less:
S. No.
Import Item
For Export of I No.Tablet
120ms
l80me
240me
1.
Verapamil Hcl USP
l22.4mg
l83.6mg
244.8mg
う
ι
Sodium Alginate
105.Omg
l57.5mg
2l0.Omg
lcasc No.:16s/6/82-
lxrnnort
l
144 lHa Fil.
145
## Case No.:228/6/82- lpu.ty Name:NECTAR
-Mi*
Noto ate:t6tt2-
ALC4n0t4
ILTFESC|ENCES L|MTTED. IALC420 t4
23.01.20t5
- lLA File
-
!i".Nornut.,ZZ t oo t.
:01/82l050/00630/AM I 5/
l:22/24/M0/000t7 /AMtst los.oo.zo ra
n"aiaioo if nitt. f 6t't oi*ritt"r, .
ents received fro. O"p..trr,"r,t of I
their oM No. 35011/462/2014-pt(Norms) dated 20.02.2015, it was decir
under Para 4.7 of HBP vl as per details given below or as applied by the firnr
1962
)harmaceuticals vide
ded to ratify norms
r, whichever is less:
Export product
Exp. Qty.
SI No
lmport items
Qty. allowed
ks/ke
Cefpirome
Sulphate for
Injection
lkg
Cefpriome Sulphate Non
Sterile
08632
2
Sodium Carbonate
017
（
Ｊ
Acctic Acid
2.27
4
Ethylenediamine Tetra Acetic
Acid Disodium Salt Dihydrate
(EqrA)
00019
5.
Carbon DC
0083
6
Acetone
2295
:ln the light of written comments received from Department of Pharmaceuticals vide
Name:HALDIA
No/Datel1 6/82-
Re-indexed
5042015
1ハM15/
No.:69/6/E2-
party Name:WANBUnV-- Meer NolOiie:f OIAZ_
their OM No 35011/704/2013-PI{Norms)dated 20 01 2015,I was decided to ratify norms
under Para 4 7 of HBP vl as per details given below or as app‖
ed by the firm,whicheveris less:
Export product
Exp Qty
SI No
lmport items
Qty. allowed kglkg
Tramadol
Hydrochloride
lkg
Cyclohexanone
100
2
N.Bromo Anisole
つ
Ｄ
ｎ
ソ
3
Tetrahydrofuran
157
4
Isopropyl Alcohol
118
5
n-Hexane
058
6
Paraformaldehyde
029
7
Methanol
166
8
Toluene
051
9
DimethvlamineHcl
081
「「謎胤響
`旧ト
Pttw Name:WANBURY IMeetNo/Datc 16/82‐
躙児5υO餌
"ハmy隔
馳OЮO蕊m夕¬ 認開
°
"Ю
・
6%DcttDttc
062014 1
14フ
Decision:in the nght Of written comments received from Department of Pharmaceuticals
the,OM No 35011/704/2013‐ P(Norms)dated 20 01 2015′
t was decided to ratify n(
under Para 4 7 of HBP vl as per details given below or as app‖
ed by the firm′ whicheveris lc
Export product
Exp. Qty.
Sl No
lmport items
Qty a‖ OWed kg/kg
Tramadol
Hydrochloride
lkg
1
Cyclohexanone
100
2
N.Bromo Anisole
●
Ｄ
ｎ
ソ
3
Tetrahydrofrran
157
4
Isopropyl Alcohol
118
5
n-Hexane
058
6
Paralormaldehyde
029
7
Methanol
166
8
Toluene
051
9
DimethylamineHcl
081
ORGANICS LTD)
No/Date:16/82‐
):03 10784695 lDefer Date:
nent of Pharmaceuticals vide
ras decided to ratiry norms
the firm, whichever is less:
Export product
Exp. Qty.
SI No
lmport items
Qty. allowed kg/kg
MEFENAMIC
ACID
lkg
1
ORTHOcHLORO
BE■lZOIC ACID
1053
＾
Ｚ
2,3,―XYLIDINE
0806
（
３
ISOPROPYL
ALCOHOL
1763
4
METHANOL
Not shown in the
process
КAmaytakeapprOpriate actiOnasperthe decisiOnofNormsCOmtttee.
1認開。
"Ю
・
Z
「
1港枷″んだ2[協器蒻
IPEARL ORCANICS LTD)
1
戸繭
RLA Filc
;01182/050/0049E/AMt5/ l:03/95/M0/0007 t/AMtSt
‐Lic No/Date:0310784633
06062014
per the decision of Norms Co -mittee.
149
ALC4つ014
,3012015
Sion:in the‖ ghtOfwnttencOmments received frOtt bela高品eit 8f lA:r品:`:til`:t
OM No 35011/35/2014-Pl(Norms)dated 19 o2 2015′ たwas decided tO rajfy nOrms u
4 7 of HBP vl as per details given below Or as app‖ ed by the firm,whicheveris less:
Export product
Exp
Qty
SI No
lmport items
Qty a‖ owed kg/kg
lkg
1
(3S,4R(‐ 4-
FLUOROPHENYL)-3-
HYDROXYMETHYL‐
1-
METHYLPIPERDNE(S_
…
)
0 810 kg/kg
2
TOSYL CHLORIDE
0 98 kg/kg
3
TRIETHYL AMNE
0.68 ks,/kg
4
DIMETHYL AMINO
PYRIDINE
0 017 kg/kg
Ｅ
Ｊ
DICHLOROMETHANE
7 95 1it/kg
6
SESAMOL
0 55 kg/kg
7
TOLUENE
4 65 1it/kg
8
PHENYL
CHLOFORMATE
0 64 1it/kg
9
METHANOL
0 40 1it/kg
RA may take approp.iJG aEiinll
ppropriate
44
No/Date:16/82‐
雌
Direct6拮te
ud匿兜語亀
『
龍讀乱I
45
~甲¨
医閻蹄臓鮒… 隅“
1器脇5∽0500AMЫ I鷺λ乳OЮ∞
74ムMW 円
°
03Ю784664呵
ision : :ln the light of written comments received from Department of Pharmace
their oM No.35OL1/7LO/2013-Pl(Norms) dated 17.02.2015, it was decided to ratify
r Parc 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is
Export product
Exp. Qty.
SI No
lmport items
Qty a‖ Owed kg/kg
SERTRALl■lE
口Vい
0^r uI∩
DInr
lkg
1
METHANOL
378
2
ISOPROPYL
ALCOHOL
075
3
D MANDELIC ACID
0392
4
TETRALONEIMINE
327
5
n-Hexane
047
take
action as per the decision of Norms Committee.
appropriate
ｕ
ｔ
ｉ
ｃ
ａ
‐
¨
‐
ｅ
ｓ
ｓ
‥
150
## Case No.:100/6/82‐
ALC4/2014
浙
16/82‐
レ■∝2015
1悧鼎α
"Ю
・“"
1柵れd¬
1器3児50Ю 050νAMly
:03/95/M0/00073/AM I 5/
: ln the light of written comments received from Department of Pharmaceuticals vide
OM No 35011/706/2013-PI(Norms)dated 20 01 2015′
lt was decided to ratify norms
under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
Export product
[Xp Qty
Sl No
lmport items
Qty. allowed
ka/ke
DIPHENHYDRAMNE
HCL
lkg
Bromine
057
2
Dimethyl Amino
Ethanol
0527
3
Isopropyl Alchohol
100
4
Mono Chloro
Benzene
058
Ｅ
Ｊ
Diphenylemethane
0997
'日
時_望里恩′N!Ry^L КυMAR
蒲i繰
―
導
Dr Drecbr ceneral群FSt:需陽。
Ⅲ亜ぷ胤f糊朧
押獣洲冊
Status:
)ecision : ln the light of written comments received from Department of Pharmaceuticals vide
reir OM No. 35011//2014-Pl(Norms) dated .2015, it was decided to ratify norms under Para
.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
Item of Export
Quantity
S,No
Item of lmport
Quantity
allowed kglkg
CEFUROXIME
AXETIL AMORPHOUS
STEARIC ACID
COATED 30%
POWDER
l kg
7 ACA (7 Amino
Cephalosporanic Acid )
0253
2
PHOSPHOROUS
PENTA CHLORIDE
03044 ′
3
(Z)2‐ Mcthoメyimino―
(Fuット2-yl)Acetic Acid
Ammonium Sal(SMIA)
0267
4
METIIANOL
0311
Ｅ
Ｊ
Methvlene Chloride
1075
6
CHLOROSULPHONYL
ISOCYANATE
O166
7
ACETONE
0925
8
TETRA METHYL
GUANIDNE
0064
9
N,N DIMETHYL
ACETAMIDE
0574
10
ETHYL ACETATE
0702
STEARIC ACID
06849
Acetic acid
00151
ACTIVATED CARBON
00314
14
POLY VINYL
PYRROLIDONE K 25
000084
## Case No.:153/6/82-
ALC4/2014
~「獄躙舎
蹄
「
ALC4/2014
23012015
,lon:ln the light Of written comments received frOm Department Of Pharmaceutica:s vide
OM No 35011/403/2014‐ PК Norms)dated 22 01 2015′ I was decided to ratify norms
r Para 4 7 of HBP vl as per details given below or as app‖ ed by the firm,whicheveris less:
Item of Export
Quantity
S′ No
Item of lmport
Quantity
allowed kglkg
Cefuroxime Axetil
amorphous SteaHc Acid
Coat 150/O Powder
l kg
1
7 ACA (7 Amino
Cephalosporanic Acid )
01265
2
Phosphorous Penta
Chloride
01522
46
⌒
3
SMIA(Z)2-
Mcthoxyimino― (Fuット2-
yl)Acctic Acid
Ammonirlm Salt
01310
4
Methanol
0156
Ｅ
Ｊ
Methylene Chloride
0537
（
ｂ
Chlorosulphonyl
Isocyanate
00832
7
Acetone
0462
8
Tetra Methvl Guanidine
00322
9
N,N Dimethyl Acetamidc
(DMAC)
0287
10
Ethyl Acctate
0351
11
Stearic Acid
08455
Acetic Acid
000753
13
Activated Carbon
0016
: It was decided to defer the case for I 8.03.2015 for comments of Department of
## Case No.:14876/82-
ALC4/2014
1拙淑
露↑
RABO日C厩
扉
戸
証
1需誦
蕗
| |
IF:ζ ,:li:「:::::「:::::「:::i「:「:「::「:i「
~~~~~~|
,3012015 1
| 1認鼎α“Ю
38842B鳶
18Ю■矧
5
Ｆ
ず
: It was decided to defer the case for I 8.03.2015 for comments of Department of
: lt was decided to defer sthe case for 18.03.2015 for comments of Department of
47
No.:67/9/82‐ ALC4/2014 Pary Name:JUBILANT LIFE
SCIENCES LIMITED
No/Date:16/82-
1器3児5υ008“AMlシ
No/Date:16/82‐
4
Party Name:INDO PHYTO
CHEMICALS PVT LTD
⌒
lfむ
:ぶ∬∴
'1/6/82-
Meet No/Date:16ノ82-
ALC4/2014
23012015
Lic No/Date:0510388672
Deffered
Re-indexed
:18032015
Re-indexed
18032015
Re-indexed
:01/82/050Ю 0553/AM15/ :05723Ю40/00107/AM15/ 113062014
23012015
## Case No:61/4/82-ALC4/2014 ParりNamc:V&V PHARMA
Mcct No/Datel1 6/82‐
lNDUSTRIES
ALC42014
: It was decided to defer the case for I 8.03.201 5 for comments of Department of
1濶…
: It was decided to defer the case for I 8.03.201 5 for comments of Department of
Date:18032015
酬
縦
2ぽ
赫
lNDIAII颯
¨
田
「
器3児50Ю
“ “
蔦
ly~臨
棚
ν∞∝3晨my l蹴
開
°引Ю
“`η 円
Decislon::n the light of written comments received from Department of Pharmaceutica!s vide
thelr OM No 35011/464/2014-PI(Norms)dated 26 02 2015′
I was decided to ratify norms
under Para 4 7 of HBP vl as per deta‖ s given below or as applied by the nrm,whicheveris less:
Export product
Exp Qty
SI No
lmport items
Qty allowed
kg/kg
2 McthyI Bcnzhdryl
Chioride
lkg
1
Sodium Borohvdride
0112
2
2 Methyl
Benzophenone
1 126
## Case No:152/6/82-
ALC4/2014
Pa●y Name:MOREPEN
LABORATORIES LTD,
## Case No:164/6/82‐
ALC4/2014
48
鵬3場50Ю""ハmy l麒蕊嗣
1需肝画面
剛
鵬
鷺5∽
““
晨m夕
彫
鵬
υO∞
“
ム剛
"圏
辮
“
Ю
"""
## Case No:142/6/82-
ALC4/2014
Party Name:DHANUKA
LABORATORIES LTD
ALC42014
23012015
:01/827050/00544/AM15/
162
Decision:ln the light of written comments received from Department of Pharmaceuticals vide
their OM No 35011/425/2014-P(Norms)dated 12 02 2015,I was decided to raufy nOrms
under Para 4 7 of HBP vl as per details given below or as applied by the firm′
whicheveris less:
Item of Export
Quantity
S′No
Item of lmport
Quantity
allowed kg/kg
Ccfpodo対meProxetil
USP/BP/1P/EP/JP
POWDER
l kg
7 Amino Ccphalosporanic
Acid(7-ACA) __
0956
2
MAEM(2-
MercaptobcnzothiazolyI
(Z)-2-(2-Aminothaizole―
4-YL)-2-Mcthoxyimino
Acetatc
0956
3
Triethylamine
047
4
I Chloro ethyl IsoProPYl
Carbonate
055
Ｅ
υ
Acetone
2475
6
Dichloro Methane
(Methylene Chloride)
3541
7
N,N― dimcthyl Acctamidc
202
8
Methanol
1481
9
l,8 DiazabiCyclo(540)
undcr 7-ENE
0319
RA may take apprOpriate action as perthe deciSiOn of Norms Committee
‘
Ｕ
164F……T ~
“
囮
:It was dCCidcd to defcrthc casc for 18 03 2015 for commcnts of Departmcnt of
10388965 Dcfer Date:
No/Date:16782‐
No.:71/9/82-ALC4/2014
Name:AVA
No/Datc:16/82-
5
Filc
.. It *^. de"id"d to defer the case for 18.03.2015 for comments of Department of
49
## Case No.:210/6/82-
Party Name:WEXFORD
ALC4/2014
LABOMTORIES P LTD
＞
Ｄ
血
油
the llght J前軸
胤温』揚
=牛
HC
fttlyL棚箋χ織笹晰繰篤:?
casc was dcfcrrcd for 18 03 2015
## Case No.:59/9/82-
ALC4/201
´
０
l Lc4not4
lo,
Fa F,r;=_-- -
-Ei
l01/82l050/00856/AMt 5 t
):03
lDecision : tn the light of w
their oM No. 35On/ 483/2074
under Para 4.7 of HBp v1 as oer
.ii,il;ii;'d'"" ""*"^ iff:'J"'ate:
t 6/82' lsrar**-
,rr.o,.]f,'!
/epproveo
l.rlji^,&@,@l,*",D","
ln.comments received from O"pa.tr*r,t of et a,,aaurtiaat, ,iU"
-1t1tl3rm.s) dated January 2015, it was decided to ,.,,rr-r;;;,
detail< oh,a^ h-t^... ^- - -
ユニ
==ユ
ニl υi dSapp"ed bythe lrm,whlc
Lxp
Qty
SI No
lmport itenrs
Qtv.
allowed
慧占)3ζ,ANHA LX rRACT
l Kg
1
!rLしACUANHA ROoTs
4 091 kg
may
Per a●ove decisiOn Of NC
&RESINS PvT LTD
: It was decided to A"f",
N(ゾDate:16/82‐
Name:PAYAL
No/Date: l6182-
2014
:It was decided tO defer the :iii[罵黒
「5FE尾扁層
lllil:1重
JttLi
No:211/6′82-
「 M
曰2躙
児5剛鯰3ムm夕
開
面
高
蕊
戸
籠ザ鼎
前
"∞
6飾0拙
8鵬釧
5
1需輛
蕊
齋
高
面
`d to defer而
蔽T而
姉
:。mmcnぉ。fDcp面0耐Of
23012015
:01/82/050/00885/AM15/
Status:
Approved
Decision : In the light of written comments received liom Departmenr of pharmaceuticals vide rheir oM
No. 3501 I /386/20l4-PI(Norms) dated 22.0r.2015, it was deciied to ratiry rhe norms under para 4.i of
I HBP Vl as perdetallsgiven beloworas appltdbythe frlll,whlcheverヽ
Lss
責輌
:瞥К
uM独 ~
―
FLC4/2014
脇
罷
「
EM PRIVA‐
1錯
∫1鰍F
η
鵬
島児50/006Bハmy
鵬
蹴
OЮ劇91/AM14/ 1脚
鼎
NげDate:16/82‐
Decision : lt was decided to
Pharmaceuticals.
defer the case for 18.03.201 5 for comments of Department of
Export Product
Export
QuantiW
S
No
lmport Item
Q″ A1lowcd
kノkg
Uroscan-76(Diatrizoate
Sodium and
DiatrizoateMeglumine
Injection USP 760
mg/ml)
l kg
l
Diatrizoic Acid
31.358gm/50m1 vial
RA may lake appropriate action as per the decision ofNorms Committee.
## Case No.:1/6/82-ALC4/2014
CHEMICALS PVT LTD,
Re-indered
Re-indexed
: It was decided to defer the case for I 8.03.201 5 for comments of Department of
冨¨ 鶴願い1濶…
|
177
ision:in the light ofwritten comments receivcd 6Ю m Department of Pha:‖ laceuticals vide their C
35011/467/2014‐PI(Nol‖ is)datCd 02 02 2015,l was decided to raJ～
the nOl‖ Is under Para 4 7
'vl as pcr detans given below or as apphcd by the rli‖
1,WhiChever is iess:
Export Product
Export
Quantity
＆
、
lmport Item
Qty. Allowed
Prednisol Solution for
Injection 30mg/l ml vial
l kg
l
PREDNISOLONE
SODiUM PHOSPHATE
BP
40 348 mg fori ml
vial
may take appropriate
as per the decision of Norms Committee.
No.:13/9/82-ALC4/2014
口
9日孫薦蔦肩
~鵬
蹴。Ю高蕊戸
脇8Ю■
2釧5
: It was decided to defer the case for 18.03.2015 for comments ofDepartment of
## Case No.:98/9/82-
ALC4/2014
C&PC
Re-indexed
: It was decided to defer the case for 18.03.2015 for comments of D€partment of
Mcct No Datc:16/82‐
ALC4/2014
Deffered
Re-indexed
Re-indexed
23012015
:It、vas dccided tO dcferthc case for 18 03 2015 for commcnts of Departmcnt Of
## Case No:25/9/82-ALC4/2014
PばりName;DIVIS
PHARMACEUTICALS
PRIVATE LIMITED
F～ |
鵬3月50Ю∝ЪAMw l鵬
馳
900347/AM Ы
## Case No.:107/9/82-
ALC4/2014
蟷3田
星掲5υ∞
"4AMЫ
I賜
棚
OЮ∞
"ム
Ⅲ
夕 1鼎
鼎
°2mm"B宥
1&"2m5
IMl蕊
雷
高
温I諦
価
高
: ~
Meet NO′Date:16/82‐
ALC4/2014
Deffered
Re-indexed
Re-indexed
184
23012015
:01/82/050700409/AM15/ 1:03/94/040/00321/AM15/
:lt was decidcd tO dcfcrthe case fOr 18 03 2015 for commcnts ofDcpartmcnt of
## Case No.:48/9/82‐ ALC4/2014
:It was decidcd tO dcfcrthc case for 18 03 2015 for commcnts of Dcpartmcnt of
ALC4/2014
23012015
## Case No:7/6/82-ALC4/2014
Pa■y Name:AARTI DRUGS
LIMITED
File
File
SM PRIVATE LIMITED.ALC4/2014 and Re―indexed
PharmaccudcJs_ |⌒
## Case No.:32/9/82‐ ALC4/2014
掟6鵬
3児50Ю
“
29/Am夕 1賜
淵
OЮO102/Am夕
]鼎
器
αtt Ю0404“
Btt18Ю ■知
5
23012015
: It was decided to defer the case for 18.03.2015 for comments ofDepartment of
Case No,:8/6/82-ALC4l20l4 Party Name:V& V PHARMA
Meet No/Date:16/82‐
INDUSTRIES
ALC4/2014
PartyName:CHEMCON MeetNo/Date:16/82-
SPECiALITY CHEMICALS iALC4/2014
No.:58/9/82-ALC4/2014 Partv Name:G AMPHRAY
Meet No/Date:16/82-
LA30RATORIES,
ALC4/2014
Re-indexed
Re-indexed
Re-indexed
Re-indexed
蟷7鵬
3児5品
10晨m夕
障念監
υ∞
"鳳
M15/ 1器
開
°
"Ю
零7382B宥
l&“ 2側5
23012015
■8陽
3児釧∞田7AMV障
ち鵬
υ∞m2晨剛yぼ
¶ 鼎
α酬
∞ω
"° Bttl&"2∝
5
## Case No.:20/9/82-ALC4l20l 4 Party Name:AUROBINDO
: lt was decided to defer the case for 18.03.2015 for comments ofDepartment of
“
9鵬
3月5υ∞“
5晨MⅣ 障λ
ttυOmηAM「
~願瓶語。∽Ю
・Ъ
・Btt18Ю32015
23012015
: It was decided to defer the case for 18.03.2015 for comments ofDepartment of
## Case No.:49l9/82-ALC4l20l4 Party Name:SANMAR
Meet No/Datel1 6/82‐
SPECIALITY CHEヽ41CALS iALC42014
LIMITED,
23012015
Lic No/Date10410159125'Defcr
:04/24/040/00106/AM 15/ 101082014
: lt was decided to defer the case for 18.03.2015 for comments of Department of
踪滞“
ALC4/2014
23012015
'0器3児50Ю0846ハ肝
蹴危鵬OЮmOαAM Ⅳ
朗
鵬
島児mЮ
“
矧AMy脂
ら鵬
OЮ∞η Amy l蹴
辮
Ю釧°78700B府
1&“2m5
蹴
¨
Casc No.:31/9/82-ALC4/2014 Party Name:AMBERNATH
ORCANICS PVT LTD
Decision : It was decided to defer the case for 18.03.2015 for comments of Department of
LTD
Re-indexed
⌒
|
lc&PC..
## Case No.:10/6/82-ALC4/2014P″ けName:COVALENT IMeetNυ Date:16/82‐
ALC4/2014
23012015
Re-indexed
18032015
Re-indexed
18032015
3 It was decided to defer the case for 18.03.20 [ 5 for comments of Department of
~ドa"N∝W9渇ZALC4/2014
Meet No Date:16/82-
ALC4つ014
Re-indexed
23012015
1脚鼎
e091∞“"7
18032015
:ln the light of written comments received from Department of Pharmaceuticals vide
OM No 35011/221/2014‐ PI(Norms)dated 18 02 2015,It was decided to call■
om the f11111
information:
i)
Consumption data of 16 raw materials used in manufacturing of Enoxaprin Sodium
Injections pre-filled Syringes duly certified by Central Excise Authority for the year
2012-13,2013-l4 and April to December 2014.
iD
Copies of batch log sheets for the last 5 consecutive batches for conversion of Heparin
Powder into Enoxaprin Sodium indicating the actual consumption of all raw materials
consumed for getting the API used in the Enoxaprin Sodium injections.
iii)
Copies of batch log sheets for last 5 consecutive batches indicating actual consumption
of 16 raw materials applied for import in all applications against export of Enoxaprin
Sodium lnjections in pre-filled syringes.
The information sought vide ltem No. 2 and 3 above may be certified by production in-
charge of manufacturing unit ofthe firm.
The case was deferred for 18.03.2015
Deffered
Re-indexed
Lic No/Date:0910060796
04082014
1器島掲
50Ю082ムMly
Lic No/Date:0910060793
:09/24/040/00203/AM15/
Partv Name:GLAND
PHARMA LIMITED
196
No.:12/6/82-ALC4/2014 ParりName:ANUPAM
ま,―]鱗聴
R
υ鑢運罵凩
Ｃ
Ｊ
ξ
′
iMeet No/Date:16/82-
PRIVATE
器
3児50Ю042/AMⅣ
陽角鵬
OЮ02餌ハШ 夕
5/ :08/24/040/00173/AM15/ 104 08 2014 Datel18 03 2015
| IRASAYAN(DJDIADLTD I錯
″ 盤r
「
nd Re‐hdexd
l鵬
掲5∽m4晨my膿
蹴
OЮ∞%晨my l蹴
辮
例Om博0厩
蘊
薫
|:11111::il」IISdecidedtOdeferthccasefbr18032015forcommentsofDepartmcntof
ド
¨
輌
耐「M柵
ざ
躍
ぽ
産
田
繭
H¶辮m"%71拙m箆劇
5
:It was dccidcd tO dcferthe casc fOr 18 03 2015 for comments of Department of
|万に3“ L:23/9/82‐ ALC4/20141PawNameBЮ_TECH
56
r18 03 2015 for comments of Deparment Of
No:lo5/9/82-
LTD,
No:53/9/82_ALC4/2014
Namc:ONEIRO
LTD
NameiSCOTT_EDlL
No/Date:16/82-
No/Datc:16/82-
Re-indexed
Re-indexed
Re-indexed
No.:93/9/82‐ ALC4/2014
Namc:YASHO
No/Date:16/82‐
5
11/AM15/ 1l o8 2014
:It was decided tO defcrthe case fOr 18 03 2015 for commcnts of Dcparment Of
:It was decided tO deferthc casc fOr 18 03 2015 for comments ofDeparment Of
OPHTHALMICS PVT LTD,
:01/82/050/00820ノAM15/
Lic No/Datc:0810132955 Defer
DeFFered
Re-indexed
lUSTRIESI躙
…
甲
Mtt B私8回5
| IЮ 1/82/050/00818/AM15/ :13泡4/040/00020/AM15/ 112 08 2014 Date16 U
I De憂罵百五菰扇孤:丁お面5「■品ぉeぉrlI魔2015おr commtts ofDepttmentof
|
3 It was decided to defer the case for 18.03.201 5 for comments of Department of
Re-indexed
Date:18032015
Re-indexed
ILic Nυつate:0515390638
匹
Case N∝52/9/82‐ALC親帆4歴亜
縞
雨
雨
「
~|
¨
Party Name:JAGSONPAL
PHARMACEUTICALS LTD
: [t was decided to defer the case for 18.03.2015 for comments of Department of
: It was decided to defer the case for I 8.03.2015 for comments of Department of
No.:61/9/82-ALC4/2014 Pary Namc CONCORD
ヽ4eet No/Datc■6/82‐
LTD
雨
面雨
=正
昴而π
「
I顧雨』hcRANBAXY MeO No/Date:16/82‐
LTD
:it was dcCided to dcferthe case for 18 03 2015 for commcnts of Department of
10390634
PHARMA PVT LTD
ALC42014
23012015
Re-indexed
Re-indexed
18032015
18032015
Deffered
Re-indexed
18032015
一
２
０
９
RLA Filc
明
O159266
:01/82l050/00849/AMl5/ :04/241040/00ttttAMt5t
:It was dccided to deferthc case for 18 03 2015 for commcnts of Dcpaltment of
P肛りName:NDO
:Ⅸ鶴離留.cALS I錯品
1盤:
:It was decidcd tO deferthc case for 18 03 2015 for cOmments of Dcpanmcnt Of
210
面
「
需
霜
爾
需
戸
1野獅FttT
鵬
星掲5∽∝32/Am夕 1胤
鵬
ν∞節3ハmy l器
鼎
酬
∝
""7
:It was dccidcd tO deferthe casc fOr 18 03 2015 for cOmmcnts ofI)epartment of
No,:36/9/82-ALC4/20 t4 Party Name:CADILA
ヽlect No′Datel1 6/82‐
HI躙
児5∽
“ "晨
my
膨
棚
OЮυ ∽晨my l蹴
鼎
C囲∝
""6
:It was decided tO dcferthe case for 18 03 2015 for comments OfDepaiment of
Party Name:VENUS
REMEDIES LTD,
Isron : In the light of written comments received fiom Department of pharmaceuticals yide their OM
3501l/387/2014-Pl(Norms) dated 2Z.Ot..2Ot5, it was decided to ratig, the norms under para 4..1 of
vI¨ pcr de●it」vcn bdow or¨ apphed byhe n品,■品語姦II:ζ
ofNorms Comminee.
畷
:
## Case No.:109/9/82‐
ALC4/2014
Meet No/Datcl1 6/82-
Vincristine Sulphate
Injection USP
Vincristine Sulphate
1 10mg/1 ml宙al
And
2 20mg/2ml宙al
appropriate action as per
58
No/Date:16/82‐
⌒
F…
/9/82‐ALC4/2Ш
I鱚柵sm
HQ Flle RLA File
213
Lic No′ Date:0810133103
:O1/82/050/00839/AM15/ 1:08/24/040/00197/AM15/ 26082014
18032015
214
鵬
鬼50Ю∝42/Amy
膨
鵬
∽O196/AMЫ I器
鼎
e081T""9躊
18朗2創5
## Case No:244/13/82-
ALC4/2014
Party Name:DELTA
FINOCHEM PVT LTD
Status:
Approved
:01/82/050/01247/AM15/
:03/94/040/01110/AM14/
1撚鼎°
"Ю
・“"町
Decision : ln the light of written comments rece市
ed from Department of Chemicals and
Petrochemicals vide their U O No 14010/44/2012-Ch ll dated 20 05 2013′
it was decided to
rajfy norms under Para 4 7 of HBP vl as per deta‖ s given below or as apphed by the irm′
whicheveris less:
Export product
Exp
Qty
SI No
lmport items
Qty. allowed
Ethyl TriphenylPhosphonium
Bromide
l kg
1
Tri Phenyl Phosphonium
0 780 kg ′
2
Ethvl Bromide
0 361 kg /
215
Lic No Date:0510390783
Re-indexed
15042015
:01/82/050/00840/AM15/ :0524/040/00203/AM15/ 27082014
## Case No.:4379/82-
iALC4/2014
123012015
No/Datc:16/82‐
No:45′9/82-ALC4/2014
Name:CONCORD
No/Date:16/82-
LTD
NamcISARV BIO
No/Date:16′ 82‐
2015
: lt was decided to defer the case for I 5.04.201 5 for comments of Department of
No:60/9/82-ALC4/2014
Namc:JUBILANT
No′つate:16/82-
LTD
File
: It was decided to defer the case for 18.03.2015 for comments ofDepartment of
59
P征けNamし:S v cHEM Meet No/Date:16/82‐
:It、vas dccidcd tO dcferthc case for 18 03 2015 for commcnts ofI〕epartmcnt of
No:75/9/82‐ALC4/2014
Name:NEUTEC
No′1)atel1 6/82‐
THCARE(P)
1310047642
No/Date■6/82‐
Re-indexed
Re-indexed
Re-indexed
Re-indexed
:It was decided tO deferthe case for 18 03 2015 for cOmments OfDepaltment of
No.:14/13/82-
Name:PllNDUSTRIES
No Date:16/82-
F‖ e
No.:2/9/82‐ ALC4/2014
Name:PERKIN
No.:_9/9/82-ALC4/2014
Name:HETERO
LIMITED
5/ :o924/040/00362/AM15/
Name:CONCORD
:It、vas dccided tO dcfcrthc casc fOr 18 03 2015 fOr cOmments ofI〕cpartmcnt Of
:It was decidcd tO deferthe case for 18 03 2015 for cOmments of Department of
:It was dccided to deferthe case for 18 03 2015 for cOmments Of Department Of
|
RLA Fnc
:01/82/050/00900/AM15/ :09/24/040/00365/AM15/
zzo lnq Fi6-trA
Flt"
脇鵬
OЮ
"ぉムⅢ夕 囲器
におNo/DateЮ910061084
一
―
―
―
１
２
２
７
‐
‐
‐
l:01/82/050/00908/AMt5/
t1:09/24/04O100346/AMl5/
Party Name:HONOUR LAB
Meet No/Date:16/82‐
LIMITED
ALC4/2014
23012015
18032015
:18032015
Re-indexed
18032015
Re-indexed
1133児50/009H/AM15/ 隔角5:::10386/AM15/
一
２
２
８
ud菫ヽ肌謀瓢
IЫ
: It was decided to defer the case for 18.03.2015 for comments of Depadment of
## Case No.:117/9/82-
Partv Name:INCHEM
ALC4/2014
LABORATORIES PRIVATE IALC4ρ
014
LIMITED
## Case No.:103/9/82-
ALC4/2014
Lic No/Date:0910061074
## Case No.:104/9ノ82-
ALC4/2014
## Case No.:114/9/82-
ALC4/2014
Name:NEULAND
TORIES LTD
No.:111/9/82-
NamelHETERO LABS
No/Date:16/82‐
Re-indexed
Re-indexed
Re-indexed
Name:NAGARJUNA
NげDate:16/82‐
LTD
Decision
:lil111ltil,IISdecidedtodeferthecasefOr18032015forcOmmentsofI)epartment of
: It was decided to defer the case for 18.03.201 5 for comments of Department of
1器3児590"97ハMV IЪ
角鵬
OЮ
“
02ハmy"∬
辮
Ю釧∞aB9B:ti&0.2m5
日33児5∽B57AM W
隔
危棚
OЮ∞92晨m夕 1芳
∬ZttЮ
・
m07026B鶏
8Ю ■2∝5
甲躙罐鱚
、my階∬辮“Ю期"5Bttl帥
"釧
5
「18 03 2015 for corrlments ofI)epartment of
:It was decided to deferthc case for 18 03 2015 for commcnts ofI)cpartment of
¨
―
―
―
―
―
―
―
―
|
No.:2/16/82‐ ALC4/2014
NameiVENUS
No′つate:16/82-
LTD,
Re-indexed
No.:3/16/82-ALC4/2014 Par●Name:VENUS
LTD,
No.:5/16/82-ALC4/2014 Pa●y Name:MEDREICH ,Meet No Date■6/82-
Re-indexed
2015
: lt was decided to defer the case for I 8.03.2015 for comments of Department of
No.:4/16/82-ALC4/2014 ]Pary Name:MICRO LABS Meet NolOate: tOIAZ-
: It was decided to defer the case for 18.03.2015 for comments ofDepartment of
⌒
|
IPhallllaccuticals
## Case No.:6/l 6/82-ALC4l20l 4 Party Name:RELIANCE
:01/82/050/01358/AM15/ :03/95/040/00351/AM 15/
## Case No.:7/16/82-ALC4l20l 4 lParty Name:RELIANCE
ヽlcct No′1)atc:16/82‐
INDUSTRIES LTD
A LC4/2014
23012015
1非鮮"
Ｆ
‐
‐
‐
２
３
‐
‐
‐
71爾薦蕊薦丁1麒∝
4魔Ⅲ夕 IⅧ器°∞Ю
"盤ω
1器3児5υO136 VAM I夕
RLA File
:09/24/040/00547/AM15/
1悧鼎α醐∞a,0
ision:In l
35011/360/:
)vl as per d
:he light of written comments received fiom Department of Pharmaceuticals vide their C
l0l4-Pl(Norms) dated January,20l5, it was decided to ratiry the norms under Para 4.7
etails given below or as applied by the firm, whichever is less:
仰
両
Ｅ
Ｐ
聯
¨
ま
、
Import Item
Qty
Allowed
Kg/Kg
Cefixime
l kg
1
7-Phenylacetamideo-3 -Ch loromethyl
Cephalosporonic Acid Para Methoxybenzyl
Ester (GCLE)
150
2
Triphenyl Phosphine
082
3
Activated Carbon
005
4
Dimethvl Formamide
280
5
Methylene Chloride
1000
6
Mica Ester
082
LTD
Re-indexed
: lt was decided to defer the case for 18.03.2015 for comments ofDepartment of
No.:8/16/82-ALC4/2014
NamelRELIANCE
No′1)ate:16/82-
LTD
Re-indexed
15/ :03/95/040/00243/Aヽ115/
No.:9/16/82-ALC4/2014
NameiCOVALENT
No/Date:16/82‐
63
may take appropriate action as@
Cas€ No.: I l/16/82-
ALC4/2014
## Case No.: l0116/82-
ALC4/2014
:聰甜鰤
鱚
躊
淑
:JODAS
Ё 雨
硼
き揚
:16/82
Re-indexed
Re-indexed
:It was decided tO deferthc case for 18 03 2015 fOr cOmments OfDepartmcnt Of
21012015
:It was decided tO deferthe case for i8 03 2015 fOr comments OfDepartment Of
l,lrnlc
:It was dccded b detrthe case fOr 18 03 201「
『
冨扁扇面高票嵩爵丁
t,ir●lc
:Itwas decidcdtO defcrthe casc fOI頂薫万2015 fOr cOmmcnts OfDepartment of
l,in,lc
## Case No:12/16/82-
ALC4/2014
Party Name:RA CHEM
64
NO/Date■6/82-
LIMITED
Re-indexed
No.:14/16/82-
Name;HERBOCHEM
Re-indexed
.2015
lDate:18.03.2015
: It"w.as decided to d"f". th" ."." foit 8.010 t 5-f*;rrrt.;f
D"p",il"t "f
## Case No. B- I
M77s Chiral Bio Scicncc Ltd
Meeting No. l6lAMl 5 dated - 27.02.20 I 5
F No01/82/162/00163/AM13/DES I11
RAF. No. 09/4/040/00102/AM 10
Adv Lic No 0910038495 dated 08 07 2009
Decision: Committee consider the case as per agenda and in consultation with technical authority
present in the meeting. It was decided to reject the request ofthe firm as there was nojustifications
for enhancement maintain status quo.
## Case No. B- 2
IWs Enaltec labs pvt ltd
Meeting No.l6lAMl5 dated - 27.02.2015
F No01/82/050/00147/AM14/DES‐
IⅡ
RAF. No. 03/941040/01040/AM 13
Adv Lic No 0310728023 dated 13 03 2013
Decision: Withdrawn as the case was already decided by NC in its 14lAM14 meeting dated
24.10.2013 and the decision of NC are also available on DGFT website under the following
link:
http:i/dgft.gov.in/ - Cornmittee Cases--Norms Committee-III--201 3-1 4---
I 4/82 rneeting dated 24.10.2013.
Casc No B-3
M/s Kopran Limited
Meeting No.16iAM15 dated - 27 .02.2015
F No01/82/050/01024/AM]1/DES―
III
RAF. No. 03/9410 4o/oos7 t/ AMtr
Adv Lic No 031060181l dated 18 11 2010
Decision : Committee considered the case as per agenda and in consultation with technical authority
present in the meeting, it was declded to amend the UOM (Unit of Measurement) as 1 kg instead of 1
No. Rest of minutes will remain same.
## Case No. B- 4
Mls ind― Swi■Laboratories Ltd
Meeting No. I 6/AM I 5 dated - 27.02.201 5
F No01/82/050/01387/AM13/DES―
III
RAF. No. 22 / 2a / O4O / OOO47 / AMt3
Adv Lic No 2210013408 dated 27 11 2012
Decision: Committee considered the representation of the firm, and it was decided to amend the
description of Import item Sl. No.3 as "Thiophene-2-Ethonal" instead of " Thiphene-2-Ethonal"
without any other change in the earlier decision ofNC.
Ｅ
Ｊ
ε
υ
## Case No. B-5
M/s Neuland laboratories Ltd
Meeting No.l6lAMl5 dated - 27 .02.2015
F No01/82/050/01643/AMl1/DES― IH
RAF. No. 09/241040/00519/AM11
Adv Lic No 0910045550 dated 14 02 2011
Decision: Committee consider the case as per agenda and in consultation with technical authority
present in the meeting. It was decided to reject the request ofthe firm as there was no justification
for enhancement. Maintain status quo.
Casc No B‐ 6
M/s Cadila Hea!thcare Ltd
Meeting No.l6lAMl5 dated - 27.02.2015
F No01/82/050/01323/Aヽ413/DES― IⅡ
RAF. No. 08/241040/00301/AM 13
Adv Lic No 0810116729 dated 07 12 2012
Decision : Committee consider the representation of the hrm and in consultation with the
technical authority present in the meeting, it was decided to revise the norms ratified earlier
in its 10/82 meeting dated 22.08.2013 as per details given below or as applied by the firm,
whichever is less:
Export Product
Export
Quantity
S.No
lmport item
Quantity
allowed kg,/kg
Losartan Potassium
l kg
1
Toulene
14688
り
‘
1-Triethyl-5-[4'-(Bromomethyl) {1,1 -
Biphenyl)4-yll 1 H-Tetrazole
14892
3
2-Butyl-4-Chloro-5-Formyl
lmidazole (BFCI)
051
4
Aceto N k百le
3264
5
Methylene Chloride (MDC)
17442
6
N-Heptane
1 2648 Ltrs
## Case No. B-7
M/s Mepro Pharmaceuticals Pvt Ltd.
Meeting No.l6lAMl5 dated - 27.02.2015
F No01/82/162/00H4/AM15/DES― IⅡ
RAF. No. 03/86/0 40 /oo2s2 I AMIL
Adv Lic No 0310621914 dated 18 03 2011
Decision: Committee consider the case as per representation of the firm and it was decided to send
the copy of representation of the firm to Department of Pharmaceuticals for their comments. The
case is deferred for next NC.
師
緩
66
## Case No. B-8
M/s Suven Life Sciences Ltd.
Meeting No. I 6/AM I 5 dated - 27 .02.2015
F NoO1/82/050/01735/AMl1/DES― HI
RAF No 09/24/040/00393/AMll
Adv Lic No 0910044624 dated 09 12 2010
Decision : It was decided to defer the case for comments of Department of Pharmaceuticals.
## Case No. B-9
M/s Century Pharmaceuticals Ltd.
Meeting No.l 6/AM I 5 dated - 27.02.201 5
F NoO1/82/162/00057/AM15/DES―
III
RAF No 34/24/040/00211/AM12
Adv Lic No 3410032814 dated 04 01 2012
Decision: Committee considered case as per agenda and in light of written comments forwarded by
Department of Pharmaceuticals vide their U.O. No.350l | 162212013-Pl-lll d^ted 24.12.2013
^nd
in
consultation with technical authority pres€nt in meeting, decided to ratiry norms under p ra 4.7 of
HBP as per details below or as applied by firm whichever is lower:-
Export product
Exp
Otv
SI No
Import items
Qty.
allowed
Oxytetracycline Base
BP (lniectable Grade)
l Kg
|
Oxytetracycline Hcl BP (non Injectable
Grade)
l135 kgkg
RA concemed may take further necessary action as per above decision ofNC.
## Case No B‐ 10
M/s Alembic Pharmaceuticals Ltd.
Mccting No 16/AM 15 datcd-27022015
F No01/82/050/00478/AM14/DES IH
RAF No 34/24/040/00069/AM14
Adv Lic No 3410037343 dated 04 07 2013
Decision: lt was decided to send a copy of application to Department of Pharmaceuticals for
their comments. The case was deferred for next meeting.
Casc No B― ll
M/s Alembic Pharmaceuticals Ltd.
Meeting No.l6lAMl5 dated - 27.02.2015
F No01/82/050/01114/Aヽ114/DES― II
RAF No 34/24/040/00213/AM14
Adv Lic No 3410038534 dated 25 11 2013
Decision: lt was decided to send a copy of application to Department of Pharmaceuticals for
their comments. The case was deferred for next meeting.
靡
珈
螂
織
ツ£壼晏亀臨
。
d凛朧罵FI軍「
67
## Case No B-12
M/s DSM An■―
lnfectives lndia Ltd′
MeeJng No 16/AM15 dated-27022015
F. No. 01/82ls0/00s42/AM08/DES-t I
F.No. 01/82ls0/002s3/AM08/DES-
F.No. 01/82ls0/00410/AM08/DES-
RLA F No 22/24/040/00016/AM08
RLA F No 22/24/040/00253/AM08
RLA F No 22/24/040/00010/AM08
Adv Lic No 2210006807 dated 18 06 2007
Adv Lic No 2210006705 dated 03 05 2007
Adv Lic No 2210006746 dated 28 05 2007
Decision : It was decided to defer the case for comments of Departmcnt of Pharmaceuticals.
Casc No B-13
M/s MSN Pharmachem Private
Mccting No 16/AM 15 datcd-27022015
F No01/82/050/00084/AM 14/DES-lH
RAF No 09/24/040/00483/AM13
Adv Lic No 0910054757 dated 10 01 2013
Decision : It was decided to defer the case for comments of Department of Pharmaceuticals.
## Case No B-14
M/s Yasho Industries Pvt Ltd
Meeting No 16/AM 15 dated-27022015
F No01/82/050/01120/Aヽ113/DES-lH
RAF No 03/95/040/00753/AM13
Adv Lic No 0310718342 dated 27 12 2012
Decision: Committee considered the as per representations of the firm it was decided to correct the RLA File
No. which was wrongly mentioned in minutes of l3lAM14 meeting was held on 03.01.2013 as details given
below:
SI No
Advance Authoriztion Nos. Mentioned in
meetins No. l3lAM14 dated 03.10.2013
Conect Advance Authorization
1
08/24/040/7583/AM13
03/95/040/00753/AM13
Rest of minutes would remain same
Casc No B-15
M/s Gopinath Chem-Tech Ltd
Meeting No.l6lAMl5 dated - 27.02.2015
F N001/82/050/00104/AM 14/DES‐ IH
RAF No 08/24/040/00436/AM13
Adv Lic No 0810119304 dated 13 03 2013
Decision: It was decided to defer the case for comments ofDepartment ofC&PC.
Casc No B 16
M/s Vivin Labs Pvt Ltd
68
Meeting No 16/AM i5 dated-27022015
F No01/83/050/00871/AM 08/DES― III
RAF No 09/24/040/00138/AM08
Adv Lic No 0910031028 dated 01 08 2007
Decision: ln the light of written comments received from Department of Pharmaceuticals vide their
OM No. 35011/531/2O14-Pl(Norms) dated 20.01.2015, it was decided to ratiry norms under Para
4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
Export Product
Export
Qtv
SI No
lmport items
Qty
a‖owed
kgノkq
5-O BENZOYL-2,3-
DIDEHYDRO-5-M ETHYL
URIDlNE(AN
INTERMEDIATE OF
STAVUDINE)
l kg
1
5-METHYL URIDINE
1327
2
N―METHYLMORPHOLINE
052 ´
3
METHANE SULPHONYL
CHLORIDE
121
4
DIMETHYL FORMAMIDE
1325
Casc No B 17
M/s Pregna International Ltd.
Meeting No.l 6/AMl 5 dated - 27.02.201 5
F No01/82/050/00941/AM 12/DES― III
RAF No 03/95/040/00635/AM12
Adv Lic No 0310665072 dated 15 11 2011
Decision: lt was decided to discuss the case in the next NC meeting.
## Case No B-18
M/s Pregna International Ltd.
Meeting No.l6lAMl5 dated - 27.02.2015
F NoO1/82/050/00692/AM 14/DES― III
RAF No 03/95/040/00191/AM14
Adv Lic No 0310737592 dated 13 06 2013
Decision:in the light of written comments received from petrochemical Division of Department of Chemicals
and Petrochemicals vide their U O No 46011/22/2008-PC―
:l dated 04 02 2015 it was decided to amend the
quantity of export(Unit Of Measurernent)as l Numberinstead of l Kg withOut anv other changes Rest Of
minutes would remain same
Casc No B-19
M/s Pregna International Ltd.
Meeting No.l6lAM I 5 dated - 27.02.201 5
F No01/82/050/00544/AM 14/DES-lH
RAF No 03/95/040/00334/AM 14
Adv Lic No 0310743482 dated 30 07 2013
Decision: ln the light of written comments received from Petrochemical Division of Department of
Chemicals and Petrochemicals vide their U.O No. 46077/22/ 2008-PC- ll dated 04.02.2015, it was decided to
revise the norms under Para 4.7 of HBP v]- as per details given below or as applied by the firm, whichever is
less:
69
町
R A may take appropriate action as per the decision of Norms Committee.
INTRA UTERINE
CONTRACEPTIVE DEVICE―
CU 200 AG
COPPER WIRE WITH
SILVER CORE
l No
FRAME MADE OF
LDPE RESN&
BARIUM SULPHATE
HDPE GLへNULES(OR
NYLON RES「ヾ
)
MEDICAL GRADE
SOLID ROD MADE OF
POLYPROPYLENE
GRANULES
Casc No B-20
M/s Akzo Nobcl Chemicals(india)Limlted
Meeting No. l6lAM I 5 dared , 27.02.201 5
F No01/82/050/01044/AM 12/DES― IH
RAF No 31/83/040/00202/AM12
Adv Lic No 3110052229 dated 03 01 2012
Decision: It was decided to defer the case for comments of Department of C&PC.
¬n"尋諭
Deparment oi Commerce
ud語甕轟謀誡
:嗜
70
ハ
Casc No B-21
n No.ot7azosolo0740AM I 3/DES-lll
Mecting No 16/AM 15 datcd-27022015
Adv Lic No 0310706515 dated 27 08 2012
RAF No 03/94/040/00374/AM13
ment ofC&PC'
M/storal Drugs P\t Ltd
F No01/82/050/01445AM 12/DES―
III
Mcethg No 16/AM15 datcd-27022015
AdV Lic No 0510319267 dated 02 03 2012
nnr.r,ro-rcYBloqo/oo4s7/AM12
xffil;l'l;
meerins it was decided to amend tn: "-t-::"Y::"1:..:^.1^i*. "r'unn.
ur Oetails given below:
ffi:::;;;*;]ilio*' o*oo'o'uArE" without anv other chanse z
,
TE BP
NATE
にd
:」
l
Me“ngNαlaAM15 dおd~2■022015
42012
AdV LIC N0 3110046571dated 24 01 201■
一
/AM12
RAF. No. 3u24l/o4o/0o188/AM12
ハ
l猟
穏
d品豫」ven be10Wi
Ff脳1淵1呻per“ “蒟
m JN°ms Omm“0
一
zatbn
¨
71
ヘ
E卸1
casc No 3‐ 24
2州5
i首i
轟量
II尊輔1参llll榊
珊
TttI弱螂聯羅為
l蠍ぢ讐壁繁蝶ギ淵
獄与獅諄
#I締靭I番熊府漁
l動憾蜘野1驚猟覗凛
』
=鷲蝋鸞捕絨聾i熙響鯰ミ1耐濡l鳳躙胤
草
lilil:illき
翌
:キ1』《
:1磁;lillijI咄
:《:『』諜
f:l閣∫
ir雪:R111:よXl:温
`il and lts reSpCCtiVe
lで。iven helow:
i.poJ ut a"tuitt given below:
fOr duw iee
lkg°
fl
o002Q生璧
ITcHS COde
33029090_
m
Import
itme at Sl.
No.
RA NO璽匹亜璽響製ζ
## Case No B-25
M/s Elppe chemicals Private
Meeting No.16/AM I 5 dated - 27.02.201 5
F No01/82/050/00979AM14/DES―
III
RAF No 03/94/040/00552/AM14
Adv Lic No 0310752484 dated 07 10 2013
Decision : Committee considered case as per agenda and in consultation with technical authority
present in the meeting and decided to maintain Status quo.
Casc No 3-26
M/s Balaji Amines Limited
Meeting No. I 6/AMt 5 dated - 27.02.20 I 5
F No01/82/050/01003AM 12ノDES―II
RAF No 31/83/040/00197/AM12
Adv Lic No 3110052163 dated 29 12 2011
Decision: Itwas decided to defe.t@
s Balaji Amines Lim■ed
Meelng No 16/AM 15 dated…
F. No.O7/ 82/Oso lOO182AM lVDES-m
FNo 01/82/050/00445AM lo/DES Ill
72
RAF. No. 31/24/04O/OOOL7/AML7 ] eav. Lic. No. 3110043098 dated 30.04.2010
RAF. No. 31/24lO40l00081/AM1O I aOv. r_ic. No. 3110039s3s dated 10.08.2009
Decision: lt was decided to defer the case for comments of Department of C&pC.
Casc No B-28
M/s Emcure Pharmaceuticals Ltd
Mecting No 16/AM 15 dated-27022015
F No01/82/050/00297AM 15/DES-lH
RAF No 31/83/040/00197/AM14
Adv Lic No 3110062302 dated 27 01 2014
Decision: It was decided to defer the case for comments of Departmint or phurrnaceutlcars-
## Case No B_29
M/s Emcure Pharmaceuticals Ltd
Mccting No 16/AM 15 dated-27022015
F No01/82/050/00541AM 15/DES― III
RAF No 31/83/040/00007/AM15
Adv Lic No 3110063591dated 24 04 2014
Decision:CommitteeconSideredcaSeasperagen
present in the meeting and decided to maintain Status quo.
Casc No 3-30
M/s Salvi Chcmical industries Limited
Meeting No. l6lAM t 5 dated - 27.02.201 5
F No01/82/050/00086AM 13/DES-lH
F No01/82/050/01725AM 11/DES― ⅡI
F No01/82/050/01327AM llノlDES-lII
F No01/82/050/01726AM l1/DES―
lⅡ
RAF No 03/95/040/00935/AM12
RAF No 03/95/040/00659/AMll
RAF No 03/95/040/00479/AMll
RAF No 03/95/040/00655/AMll
Adv Lic No 0310683346dated 24 02 2012
Adv Lic No 0310614170dated o3 02 2011
Adv Lic No 0310593357dated 22 09 2010
Adv Lic No 0310614172dated 03 02 2011
Decision : Committee considered case as per age
present in the meeting and decided to maintain Stitus quo.
## Case No B‐ 31
IWs Zandu Chemicals Limited
Mceting No 16/AM 15 datcd-27022015
F No01/83/050/00428AM 06/DES‐
III
RAF No 03ノ95/040/00789/AM06
Adv Lic No 0310355085dated 10 11 2005
Decision ; Committee considered cas
present in the meeting and decided to maintain Stitus quo.
73
ヽ
／
M/s Wanbuv Ltd
## Case No. B! 2
F. N"JtS2/050/0 t 175/AM 08iDES-lll
Meeting No 16/AM15 dated-27022015
Adv Jc No豆610006381dated 14 09 2007
RAF. No. 261241040/00002/4M08
Dccisioni Committee considered the Case as per agenda and in COnsultation with technical
authority present in meeting′ it Was decided to revise the quantity oftwo importitems as perthe
l __ ,_^^ _^^^ ^^●
^`
out::v,,ヽγ γ'｀・・｀…｀.…
Ⅲ…‐―‐ 0′ ~
actual COnsumption certificate frOm Central Excise Authorities alongWith appropriate recovery of
solvent
Export Product
Expon
ow.
SI No
Import items
Qty. as applied bY the
firm kp&e
-sertralineHydrochloride
l Kg
l
Alpha napthol
400
つ
Ｚ
Isopropanol
360
.
No further export and import will be allowed'
o Only for regularization purpose of Adv' Lic' No 261000638l' dated 14 09 2007'
o No future Advance Authorization will be issued on repeat basis'
RA concerned may take further necessary action as per above decision of NC
f.Als e*Oua Vit labs Private Limited
## Case No B-33
n No.OtIAZOSOlO03S5AM l4lDES-lll
i\{eett"tNr t6lAMt 5 dated' 27.02.2015
laur Lic. r'to. oqlo147516dated 28.06.2013
PaP. x6. galZ+/040/00057/AM14
ent of Pharmaceuticals'
M/s SuⅣlval Tcchnology Pvt Ltd
## Case No B-34
F.N-o.-ovg2/05olo0?83/AM14/DES-lll
Mceting No 16/AM15 dated-27022015
Adv Lic No 0310751752 dated 30 09 2013
nar. No. O:/SSlO4o/Oos36/AM 14
74
Decision: committee considered case as per agenda and in light of written co;;;r,ts forwarded bt
Department of C&pC vide their U.O. No.t4O7O/62/2O7OlCh. dated 08.01.2014 and in consultation with
technical authority present in meeting, decided to revise the norms ratified earlier in its l9lg2
meeting dated 02.01.2014 as per details given below or as applied by the firm, whichever is
lessi
RA concerned may take further necessary action as per above decision of NC.
Export product
Exp.
Qtv.
SI No
lmport items
Qty. allowed
N-Methoxy-N-Methyl Acetamide
l Kg
N;o-
Dimethylhydroxyamine
hydrochloride
7.431, kg/kB
## Case No B-35
M/s Alkyl Amines Chemicals Ltd.
Meeting No.16/AMl5 dated - 21 .02.20t5
F No01/82/050/00618AM 15/DES― IH
RAF. No. 03/941040/00019/AM1s
Adv Lic No 0310785244dated 12 06 2014
Decision : It was decided to defer the case for comments of Departme.nt of C&pC
Nr'(\
ピ1lMAR
Dare:23.01.2015
Place:New Delhi
Nirmal Kumar
Dy. Director Ceneral of Foreign Trade
Ｅ
υ
７
′Verbatim extracted text (OCR/PDF). Older scans and tables may show extraction artifacts — verify against the original for anything you act on.
Analysis
No analysis has been generated for this document yet.