DGFT Committee Minutes
Office of Directorate General of Foreign Trade
New Delhi -0
Para 4.7 Decision
MEETING NUMBER
: 9/82-ALC4/2015 MEETING DATE : 30.09.2015
Meeting No. 09/82/2015 of 2015-16, to consider the cases/issues under Duty Exemption
Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products
and falling under Chapter 29 and 30, was scheduled for 30.09.2015 but actually held on 09.10.2015
under the Chairmanship of Dr. S.K. Bansal, Jt. DGFT in Room No.11, Udyog Bhawan, New Delhi.
Following members were present:-
Shri A.K. Aggarwal, Addl. Indl. Adviser, D/o C&PC
Shri Nirmal Kumar, Dy.DGFT
Shri D.N. Mathur, Consultant, Department of Pharmaceutical
Shri Mahendra Vikram Singh, Foreign Trade Development Officer
The committee went through the minutes of earlier NC –III meeting No. 08/82 was scheduled for 16.09.2015 but actually held on 21.09.2015 and approved the same.
Note:
In certain cases the decision of the Norms Committee refers to the Recommendations/ Observations / Deficiencies received from the concerned Technical authority in the same case or a different case of another firm with the same product. A scanned copy of such document is placed at the end of the Minutes. In some cases, the scanned copy uploaded may be unsigned. In both these instances, the scanned copy uploaded is to be accepted. The U.O.No. / O.M. No. of the scanned copy is reflected in the minutes.
The following cases/issues were discussed and the committee took the decision as mentioned against each case.
1
Case
No.:18/4/82-
ALC4/2015
Party
Name:SHIVA
PHARMACHEM LTD,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00057/AM16/
RLA
File
:34/24/040/00130/AM12/
Lic.No/Date:3410031902
12.10.2011
Defer Date:
Decision :The Committee decided to ratify norms for the export product Isononanoyl chloride
based on the recommendation of D/o C&PC provided vide U.O.No.14010/164/2011-Ch-II dt.
05.10.2015, uploaded along with these minutes or as applied by the firm whichever is less under
para 4.07 of HBP Vol.1. RA may take further action accordingly.
2
Case
No.:36/19/82-
ALC4/2014
Party
Name:ALKALI
METALS LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01524/AM15/
RLA
File
:09/24/040/00503/AM12/
Lic.No/Date:0910052125
12.04.2012
Defer
Date:28.10.2015
Decision :The committee decided to send copy of application to DC&PC and deferred the case.
3
Case
No.:14/19/82-
ALC4/2014
Party
Name:MYLAN
LABORATORIES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File RLA
File Lic.No/Date:0910052196 Defer Date:
:01/82/050/01502/AM15/
:09/24/040/00613/AM12/
16.04.2012
Decision :The Committee decided to ratify norms for the export product Clindamycin Palmitate Hcl
based on the recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/229/2015-PI
(Norms) dt. 07.10.2015, uploaded along with these minutes or as applied by the firm whichever is
less
under
para
4.07
of
HBP
Vol.1.
RA may take further action accordingly.
4
Case
No.:15/19/82-
ALC4/2014
Party
Name:OPTIMUS
DRUGS PRIVATE LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01503/AM15/
RLA
File
:09/24/040/00059/AM13/
Lic.No/Date:0910052628
16.05.2012
Defer Date:
Decision :The Committee decided to ratify norms for the export product “Linezolid” based on the
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/200/2015-PI (Norms) dated
11.09.2015 , uploaded along with these minutes or as applied by the firm whichever is less under
5
Case
No.:16/19/82-
ALC4/2014
Party
Name:SRINI
PHARMACEUTICALS LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01504/AM15/
RLA
File
:09/24/040/00060/AM13/
Lic.No/Date:0910052680
18.05.2012
Defer Date:
Decision :The Committee decided to ratify norms for the export product “Levofloxacin
Hemihydrate”
based
on
the
recommendation
of
D/o
Pharmaceuticals
provided
vide
O.M.No.35011/405/2015-PI (Norms) dated 05.10.2015, uploaded along with these minutes or as
applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA may take further action
accordingly.
6
Case
No.:38/19/82-
ALC4/2014
Party
Name:PORUS
LABORATORIES
PVT
LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01526/AM15/
RLA
File
:09/24/040/00050/AM13/
Lic.No/Date:0910052706
21.05.2012
Defer
Date:28.10.2015
Decision :The decided to send copy of application to DC&PC (Chemical) and deferred the case.
7
Case
No.:24/19/82-
ALC4/2014
Party
Name:SRINI
PHARMACEUTICALS LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01512/AM15/
RLA
File
:09/24/040/00062/AM13/
Lic.No/Date:0910052750
23.05.2012
Defer Date:
Decision :The Committee decided to ratify norms for the export product “Z-Valacyclovir” based on
the recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/172/2015-PI (Norms)
dated 08.10.2015, uploaded along with these minutes or as applied by the firm whichever is less
under
para
4.07
of
HBP
Vol.1.
8
Case
No.:26/19/82-
ALC4/2014
Party
Name:AUROBINDO
PHARMA LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01514/AM15/
RLA
File
:09/24/040/00093/AM13/
Lic.No/Date:0910052816
29.05.2012
Defer Date:
Decision :The Committee decided to ratify norms for the export product “Nevirapine (Navirapine
Anhydrous)” based on the recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/225/2014-PI (Norms) dated August, 2014, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.
9
Case
No.:27/19/82-
ALC4/2014
Party Name:HETERO LABS
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01515/AM15/
RLA
File
:09/24/040/00103/AM13/
Lic.No/Date:0910052815
29.05.2012
Defer Date:
Decision :The Committee decided to ratify norms for the export product Irbesartan based on the
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/205/2015-PI (Norms) dated
15.09.2015, uploaded along with these minutes or as applied by the firm whichever is less under
10
Case
No.:39/19/82-
ALC4/2014
Party Name:SUVEN LIFE
SCIENCES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01527/AM15/
RLA
File
:09/24/040/00089/AM13/
Lic.No/Date:0910052842
30.05.2012
Defer Date:
Decision :The Committee decided to ratify norms for the export product “methyl-2-(2-
Chloromethylphenyl)-3-Methoxy-2-Acrylate”
based
on
the
recommendation
of
D/o
Pharmaceuticals provided vide O.M.No.35011/198/2015-PI (Norms) dated 11.09.2015, uploaded
along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.
11
Case
No.:18/19/82-
ALC4/2014
Party
Name:MYLAN
LABORATORIES
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01506/AM15/
RLA
File
:09/24/040/00085/AM13/
Lic.No/Date:0910052887
05.06.2012
Defer
Date:28.10.2015
Decision :The Committee in light of comments of D/o Pharmaceuticals forwarded vide
O.M.No.35011/197/2015-PI(Norms) dated 24th July, 2015 decided to call for following information
from the firm:-
a) Complete technical details as per Appendix-33 showing % yield on molar basis for each
step of manufacturing process.
b) Past production vis-à-vis Actual consumption of all the imported inputs duly certified by
Central excise Authorities.
12
Case
No.:37/19/82-
ALC4/2014
Party
Name:ASTRIX
LABORATORIES LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01525/AM15/
RLA
File
:09/24/040/00079/AM13/
Lic.No/Date:0910052925
08.06.2012
Defer Date:
Decision :The Committee decided to ratify norms for the export product Efavirenz based on the
recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/212/2015-PI(Norms)
dated 15.09.2015 , uploaded along with these minutes or as applied by the firm whichever is less
under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.
13
Case
No.:6/19/82-
ALC4/2014
Party
Name:BIO-TECH
OPHTHALMICS
PVT.
LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File RLA
File Lic.No/Date:0810112710 Defer
:01/82/050/01494/AM15/
:08/24/040/00093/AM13/
18.06.2012
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments from D/o
Pharmaceuticals.
14
Case
No.:4/4/82-
ALC4/2013
Party
Name:SABERO
ORGANICS
GUJARAT
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00045/AM14/
RLA
File
:03/95/040/00880/AM13/
Lic.No/Date:0310724136
14.02.2013
Defer
Date:28.10.2015
Decision :The Committee decided to send a copy of application to DC&PC .
15
Case
No.:79/1/82-
ALC4/2013
Party
Name:STERICAT
GUTSTRINGS PVT. LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01437/AM13/
RLA
File
:05/24/040/00420/AM13/
Lic.No/Date:0510346353
18.02.2013
Defer
Date:28.10.2015
Decision :The Committee decided to send the copy of application to PC Div of DC&PC.
16
Case
No.:5/19/82-
ALC4/2014
Party
Name:COVALENT
LABORATORIES
PRIVATE LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01493/AM15/
RLA
File
:09/24/040/00633/AM13/
Lic.No/Date:0910055925
02.05.2013
Defer Date:
Decision :: The Committee decided to ratify norms for the export product Cefprozil based on the
recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/142/2015-PI(Norms)
dated October, 2015, uploaded along with these minutes or as applied by the firm whichever is
less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of
NC.
17
Case
No.:20/7/82-
ALC4/2014
Party
Name:DR
REDDYS
LABORATORIES
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00664/AM1
5/
RLA
File
:09/24/040/00041/AM14/
Lic.No/Date:0910056000
15.05.2013
Defer
Date:28.10.2015
Decision :The Committee noted that information called for from the firm is awaited. The
Committee decided to await the reply and deferred the case.
18
Case
No.:7/3/82-
ALC4/2015
Party Name:INDO PHYTO
CHEMICALS PVT LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00037/AM16/
RLA
File
:05/23/040/00042/AM14/
Lic.No/Date:0510355150
24.05.2013
Defer Date:
Decision :The Committee decided to ratify norms for the export product “Allylestrenol Bulk Drug”
based on the recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/513/2014-PI
(Norms) dated 30.09.2015, uploaded along with these minutes or as applied by the firm whichever
is
less
under
para
4.07
of
HBP
Vol.1.
19
Case
No.:22/12/82-
ALC4/2013
Party
Name:INDOFIL
INDUSTRIES LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00446/AM14/
RLA
File
:03/94/040/00197/AM14/
Lic.No/Date:0310738404
20.06.2013
Defer Date:
Decision :The Committee decided to ratify norms for the export product “Cymoxanil Technical”
based on the recommendation of D/o C&PC provided vide U.O.No.15022/17/2012-Ch-II dated
05.10.2015, uploaded along with these minutes or as applied by the firm whichever is less under
para 4.07 of HBP Vol.1.
20
Case
No.:68/17/82-
ALC4/2013
Party
Name:BHARAT
PARENTERALS LTD,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00930/AM14/
RLA
File
:34/21/040/00163/AM14/
Lic.No/Date:3410037475
23.07.2013
Defer Date:
Decision :The Committee decided to ratify norms for the export product “amoxicillin and
Clavulanate Potassium for injection” based on the recommendation of D/o Pharmaceuticals
provided vide O.M..No.35011/293/2015-PI (Norms) dated 08.10.2015, uploaded along with these
minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.
21
Case
No.:1/10/82-
ALC4/2013
Party Name:MICRO LABS
LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00184/AM14/
RLA
File
:07/24/040/00111/AM14/
Lic.No/Date:0710097180
30.07.2013
Defer
Date:28.10.2015
Decision :The Committee noted that information called for from the firm is awaited. Accordingly
deferred the case.
22
Case
No.:31/4/82-
ALC4/2014
Party Name:UNIVERSAL
BIOFUELS
PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00279/AM15/
RLA
File
:09/24/040/00155/AM14/
Lic.No/Date:0910056959
31.07.2013
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments from DC&PC.
23
Case
No.:32/4/82-
ALC4/2015
Party
Name:KLJ
PLASTICIZERS LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00071/AM16/
RLA
File
:05/23/040/00176/AM14/
Lic.No/Date:0510361463
01.08.2013
Defer Date:
Decision :The Committee decided to ratify norms for the export product “Kanatol-400(N)” based
on the recommendation of D/o C&PC provided vide U.O.No.140102/36/2011-Ch-II dated
10.09.2015, uploaded along with these minutes or as applied by the firm whichever is less under
para
4.07
of
HBP
Vol.1.
24
Case
No.:9/30/83-
ALC1/2013
Party
Name:STERICON
PHARMA PVT.LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File RLA
File Lic.No/Date:0710097668 Defer
:01/83/050/00471/AM14/
:07/24/040/00152/AM14/
22.08.2013
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments from DOP.
25
Case
No.:15/16/82-
ALC4/2013
Party
Name:ACEBRIGHT
(INDIA) PHARMA PVT LTD,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00828/AM14/
RLA
File
:07/24/040/00177/AM14/
Lic.No/Date:0710097973
03.09.2013
Defer Date:
Decision :The Committee decided to ratify norms for the export product Tenofovir Disoproxil
Fumarate based on the recommendation of D/o Pharmaceuticals O.M.No.35011/434/2015-PI
(Norms) dated October.2015, uploaded along with these minutes or as applied by the firm
whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per
decision of NC.
26
Case
No.:17/4/82-
ALC4/2015
Party
Name:JUBILANT
LIFE SCIENCES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00056/AM16/
RLA
File
:05/23/040/00211/AM14/
Lic.No/Date:0510364363
04.09.2013
Defer
Date:28.10.2015
Decision :The committee decided to send copy of application to DC&PC.
27
Case
No.:22/17/82-
ALC4/2013
Party
Name:ATHENA
DRUG
DELIVERY
SOLUTIONS
PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00884/AM14/
RLA
File
:03/94/040/00458/AM14/
Lic.No/Date:0310753955
17.10.2013
Defer Date:
Decision :The Committee decided to ratify norms for the export product “Theophylline Sr/Er
Pellets”
based
on
the
recommendation
of
D/o
Pharmaceuticals
provided
vide
U.O.No.35011/65/2015-PI(Norms) dated 11.09.2015, uploaded along with these minutes or as
applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA may take further action
accordingly.
28
Case
No.:36/19/82-
ALC4/2013
Party
Name:SOHAM
ORGANICS PVT LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00981/AM14/
RLA
File
:31/83/040/00124/AM14/
Lic.No/Date:3110060943
29.10.2013
Defer
Date:28.10.2015
Decision :The committee noted that information called for from is awaited. The Committee
accordingly deferred the case.
29
Case
No.:51/18/82-
ALC4/2014
Party
Name:GALAXY
SURFACTANTS LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01417/AM15/
RLA
File
:03/94/040/00638/AM14/
Lic.No/Date:0310756247
30.10.2013
Defer Date:
Decision :The Committee decided to ratify norms for the export product “Octyl Diphenyl
cyanoacrylate”
based
on
the
recommendation
of
D/o
C&PC
provided
vide
U.O.No.14010/148/2011-Ch-II dated 30.09.2015, uploaded along with these minutes or as applied
by
the
firm
whichever
is
less
under
para
4.07
of
HBP
Vol.1.
30
Case
No.:140/23/82-
ALC4/2013
Party
Name:UNITED
PHOSPHORUS LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01187/AM14/
RLA
File
:03/95/040/00495/AM14/
Lic.No/Date:0310758627
21.11.2013
Defer
Date:28.10.2015
Decision :The committee decided to defer the case for want of comments from DC&PC.
31
Case
No.:181/3/82-
ALC4/2014
Party
Name:AKZO
NOBEL INDIA LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00185/AM15/
RLA
File
:02/24/040/00053/AM14/
Lic.No/Date:0210198392
02.01.2014
Defer
Date:28.10.2015
Decision :The committee decided to defer the case for want of comments from DOP.
32
Case
No.:192/3/82-
ALC4/2014
Party
Name:VIVIMED
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00196/AM15/
RLA
File
:09/24/040/00513/AM14/
Lic.No/Date:0910058896
10.01.2014
Defer
Date:28.10.2015
Decision :Decision : The committee decided to send copy of application to DOP and deferred the
case for want of comments .
33
Case
No.:204/3/82-
ALC4/2014
Party Name:VIVIMED LABS
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00208/AM15/
RLA
File
:09/24/040/00514/AM14/
Lic.No/Date:0910058895
10.01.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product “9-Oxo-9H-thioxanthene-
2-carboxylic acid ethyl ester” based on the recommendation of D/o C&PC provided vide
U.O.14010/138/2011-Ch-II dated 14.09.2015, uploaded along with these minutes or as applied by
the
firm
whichever
is
less
under
para
4.07
of
HBP
Vol.1.
34
Case
No.:208/3/82-
ALC4/2014
Party
Name:OGENE
SYSTEMS
INDIA
PVT.
LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00212/AM15/
RLA
File
:09/24/040/00515/AM14/
Lic.No/Date:0910059017
22.01.2014
Defer
Date:28.10.2015
Decision :: It was decided to defer the case for want of comments of D/o C&PC .
35
Case
No.:12/21/82-
ALC4/2013
Party
Name:KUDOS
CHEMIE LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Reject
HQ
File
:01/82/050/01042/AM14/
RLA
File
:22/21/040/00096/AM14/
Lic.No/Date:2210014544
23.01.2014
Defer
Date:28.10.2015
Decision :It was decided to reject the case as the firm has not furnish requisite information
despite repeated reminders .
36
Case
No.:187/3/82-
ALC4/2014
Party
Name:ALCHEM
INTERNATIONAL LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00191/AM15/
RLA
File
:05/23/040/00413/AM14/
Lic.No/Date:0510376990
24.01.2014
Defer
Date:28.10.2015
Decision :The Committee noted that information called for from the firm is awaited. Accordingly
the Committee deferred the case.
37
Case
No.:108/3/82-
ALC4/2014
Party
Name:CROPNOSYS
(INDIA)
PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00112/AM15/
RLA
File
:03/94/040/00908/AM14/
Lic.No/Date:0310767733
24.01.2014
Defer
Date:28.10.2015
Decision :It was decided to send copy of application defer the case for want of comments of D/o
C&PC .
38
Case
No.:44/4/82-
ALC4/2014
Party
Name:CATAPHARMA
CHEMICALS PVT. LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00292/AM15/
RLA
File
:31/83/040/00199/AM14/
Lic.No/Date:3110062387
30.01.2014
Defer
Date:28.10.2015
Decision :The Committee considered the case for ratification of norms as per agenda. The
representative of C&PC explained the reason why the department has allowed 5% wastage
whoever, since the export product and import item has same description and chemical compound,
the committee decided that while fixing wastage it is necessary to specify the purity of export and
import items in the comments of each case. DC&PC may accordingly furnish revised
recommendations. The committee accordingly decided to defer the case.
39
Case
No.:177/3/82-
ALC4/2014
Party
Name:INDO
AMINES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00181/AM15/
RLA
File
:03/94/040/00958/AM14/
Lic.No/Date:0310768616
30.01.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments of D/o Pharmaceuticals .
40
Case
No.:165/3/82-
ALC4/2014
Party Name:MANGALAM
ORGANICS LIMITED.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00169/AM15/
RLA
File
:03/94/040/00448/AM14/
Lic.No/Date:0310768928
03.02.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments of D/o C&PC (Chemical) .
41
Case
No.:87/3/82-
ALC4/2014
Party Name:VIVIMED LABS
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00091/AM15/
RLA
File
:09/24/040/00544/AM14/
Lic.No/Date:0910059155
04.02.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product “Reversacol Pennine
Green” based on the recommendation of D/o C&PC provided vide U.O.14010/138/2011-Ch-II
dated 19.09.2015, uploaded along with these minutes or as applied by the firm whichever is less
under
para
4.07
of
HBP
Vol.1.
42
Case
No.:117/3/82-
ALC4/2014
Party Name:VIVIMED LABS
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00121/AM15/
RLA
File
:09/24/040/00543/AM14/
Lic.No/Date:0910059156
04.02.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product “Reversacol Humber
Blue” based on the recommendation of D/o C&PC provided vide U.O.14010/138/2011-Ch-II dated
07.07.2015, uploaded along with these minutes or as applied by the firm whichever is less under
para
4.07
of
HBP
Vol.1.
43
Case
No.:86/3/82-
ALC4/2014
Party
Name:AKZO
NOBEL INDIA LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00090/AM15/
RLA
File
:02/24/040/00197/AM14/
Lic.No/Date:0210200380
21.02.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments of D/o Pharmaceuticals .
44
Case
No.:45/19/82-
ALC4/2014
Party
Name:MYLAN
LABORATORIES
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01533/AM15/
RLA
File
:09/24/040/00600/AM14/
Lic.No/Date:0910059428
26.02.2014
Defer
Date:28.10.2015
Decision :The Committee in light of written comments provided by DOP vide No.35011/251/2015-
PI (Norms) date 5.10.2015 decided to call for past production vis-à-vis Actual consumption of all
imported inputs duly certified by Central Excise Authorities and deferred the case.
45
Case
No.:58/6/82-
ALC4/2014
Party
Name:BAYER
CROPSCIENCE LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00460/AM15/
RLA
File
:03/94/040/00797/AM14/
Lic.No/Date:0310772503
28.02.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments of D/o C&PC (Chemical) ..
46
Case
No.:106/3/82-
ALC4/2014
Party
Name:PERFECT
VITAMINS PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00110/AM15/
RLA
File
:03/95/040/00960/AM14/
Lic.No/Date:0310772411
28.02.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments of D/o DC&PC .
47
Case
No.:46/6/82-
ALC4/2014
Party
Name:NAPROD
LIFE
SCIENCES
PVT.
LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00448/AM15/
RLA
File
:03/95/040/00986/AM14/
Lic.No/Date:0310772962
04.03.2014
Defer
Date:28.10.2015
Decision :The Committee noted that information called for from the firm is waited. The Committee
decided to defer the case.
48
Case
No.:34/6/82-
ALC4/2014
Party
Name:INDOCO
REMEDIES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00436/AM15/
RLA
File
:03/94/040/00973/AM14/
Lic.No/Date:0310773112
05.03.2014
Defer
Date:28.10.2015
Decision :The committee decided to call for DML from the firm and deferred the case.
49
Case
No.:30/3/82-
ALC4/2014
Party
Name:BELCO
PHARMA
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00034/AM15/
RLA
File
:05/23/040/00479/AM14/
Lic.No/Date:0510381658
12.03.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product based on the
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/152/2015-PI (Norms) dated
27.8.2015 , uploaded along with these minutes or as applied by the firm whichever is less under
para
4.07
of
HBP
Vol.1.
5
0
Case
No.:33/10/82-
ALC4/2014
Party
Name:SMILAX LABORATORIES LIMI
TED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Cas
e
Approved
HQ
File
:01/82/050/00947/AM
15/
RLA File :09/24/040/00617/AM14/
Lic.No/Date:09100595
57
13.03.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product “Losartan Potassium”
based on the recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/178/2015-PI
(Norms) dated 5.10.2015, uploaded along with these minutes or as applied by the firm whichever
is
less
under
para
4.07
of
HBP
Vol.1.
51
Case
No.:56/4/82-
ALC4/2014
Party
Name:IND-SWIFT
LABORATORIES LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00304/AM15/
RLA
File
:22/24/040/00102/AM14/
Lic.No/Date:2210014691
14.03.2014
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/407/2015-PI (Norms) dated
October 2015, uploaded along with these minutes or as applied by the firm whichever is less
under
para
4.07
of
HBP
Vol.1.
52
Case
No.:58/4/82-
ALC4/2014
Party
Name:IND-SWIFT
LABORATORIES LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00306/AM15/
RLA
File
:22/24/040/00100/AM14/
Lic.No/Date:2210014694
14.03.2014
Defer
Date:28.10.2015
Decision : The committee noted that information called for from is awaited. The Committee
accordingly deferred the case.
53
Case
No.:57/3/82-
ALC4/2014
Party
Name:JUBILANT
LIFE SCIENCES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00061/AM15/
RLA
File
:05/23/040/00506/AM14/
Lic.No/Date:0510382053
18.03.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments of D/o C&PC (Chemical) ..
54
Case
No.:42/4/82-
ALC4/2014
Party
Name:RECKITT
BENCKISER
HEALTHCARE
INDIA
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00290/AM15/
RLA
File
:05/24/040/00480/AM14/
Lic.No/Date:0510382032
18.03.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments of D/o DoP .
55
Case
No.:51/5/82-
ALC4/2014
Party
Name:JINDAL
DRUGS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00368/AM15/
RLA
File
:03/94/040/01098/AM14/
Lic.No/Date:0310776087
27.03.2014
Defer
Date:28.10.2015
Decision :: It was decided to send copy of application to DC&PC (Petrochemical) and deferred
the case for want of comments.
56
Case
No.:127/6/82-
ALC4/2014
Party
Name:CATAPHARMA
CHEMICALS PVT. LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00529/AM15/
RLA
File
:31/83/040/00232/AM14/
Lic.No/Date:3110063312
28.03.2014
Defer
Date:28.10.2015
Decision : The Committee considered the case for ratification of norms as per agenda. The
representative of C&PC explained the reason why the department has allowed 5% wastage
whoever, since the export product and import item has same description and chemical compound,
the committee decided that while fixing wastage it is necessary to specify the purity of export and
import items in the comments of each case. DC&PC may accordingly furnish revised
recommendations. The committee accordingly decided to defer the case.
57
Case
No.:52/6/82-
ALC4/2014
Party Name:UPL LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00454/AM15/
RLA
File
:03/95/040/01043/AM14/
Lic.No/Date:0310776594
01.04.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments from D/o C&PC (Chemical) .
58
Case
No.:51/6/82-
ALC4/2014
Party
Name:PERFECT
INDUSTRIES
PRIVATE
LIMITED.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00453/AM15/
RLA
File
:03/95/040/01054/AM14/
Lic.No/Date:0310776759
02.04.2014
Defer
Date:28.10.2015
Decision :: It was decided to defer the case for want of comments from D/o C&PC (Chemical) .
59
Case
No.:50/6/82-
ALC4/2014
Party
Name:V
&
V
PHARMA INDUSTRIES
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00452/AM15/
RLA
File
:03/95/040/01061/AM14/
Lic.No/Date:0310776760
02.04.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments from D/o C&PC (Chemical) .
60
Case
No.:22/10/82-
ALC4/2014
Party
Name:OGENE
SYSTEMS
INDIA
PVT.
LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00936/AM15/
RLA
File
:09/24/040/00669/AM14/
Lic.No/Date:0910059697
03.04.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments from D/o C&PC (Chemical) .
61
Case
No.:20/6/82-
ALC4/2014
Party
Name:ADISHANK
CHEMICALS PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00422/AM15/
RLA
File
:03/94/040/01140/AM14/
Lic.No/Date:0310777786
09.04.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments from D/o C&PC (Chemical) .
62
Case
No.:1/2/82-
ALC4/2014
Party
Name:CADILA
HEALTHCARE LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00003/AM15/
RLA
File
:08/24/040/00008/AM15/
Lic.No/Date:0810130534
11.04.2014
Defer
Date:28.10.2015
Decision :It was decided to send copy of application to DoP and deferred the case for want of
comments.
63
Case
No.:32/5/82-
ALC4/2014
Party
Name:EMCURE
PHARMACEUTICALS
LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00349/AM15/
RLA
File
:31/83/040/00008/AM15/
Lic.No/Date:3110063481
11.04.2014
Defer
Date:28.10.2015
Decision :The Committee in light of the comments of D/o C&PC (Pharma) forwarded vide O.M.
No.35011/638/2014-PI (Norms) dated 28.7.2015 noted that D/o Pharmaceutical has examined the
matter and observed that additional information do not clarify the situation and the description of
export product reflected in the application i.e. 1.5gm/ml do not match with DML which is for
1.5gm/1.5ml
and
not
1.5gm/ml.
The Committee, accordingly, decided to call for clarification on the above from the firm.
64
Case
No.:34/5/82-
ALC4/2014
Party
Name:ALEMBIC
PHARMACEUTICALS
LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00351/AM15/
RLA
File
:34/24/040/00003/AM15/
Lic.No/Date:3410039800
15.04.2014
Defer
Date:28.10.2015
Decision :The committee noted that information called for from the firm is awaited. The committee
accordingly decided to defer the case.
65
Case
No.:21/10/82-
ALC4/2014
Party Name:BIOLOGICAL E
LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00935/AM15/
RLA
File
:09/24/040/00678/AM14/
Lic.No/Date:0910059795
21.04.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product “Noscapine” based on the
recommendation of D/o Pharmaceuticals provided vide 35011/74/2015-PI (Norms)I dated 11.09.2015, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.
66
Case
No.:48/10/82-
ALC4/2014
Party
Name:MYLAN
LABORATORIES
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00962/AM15/
RLA
File
:09/24/040/00650/AM14/
Lic.No/Date:0910059803
22.04.2014
Defer
Date:28.10.2015
Decision :The committee noted that information called for from the firm is awaited. The committee
according decided to defer the case.
67
Case
No.:183/6/82-
ALC4/2014
Party
Name:TIDE
INDUSTRIES
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00585/AM15/
RLA
File
:34/24/040/00005/AM15/
Lic.No/Date:3410039854
23.04.2014
Defer
Date:28.10.2015
Decision :The committee decided to defer the case for want of comments from DC&PC.
68
Case
No.:6/5/82-
ALC4/2014
Party
Name:UNITED
BIOTECH PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00323/AM15/
RLA
File
:05/24/040/00034/AM15/
Lic.No/Date:0510384810
24.04.2014
Defer
Date:28.10.2015
Decision :The committee noted that information called for from the firm is awaited. The committee
according decided to defer the case.
69
Case
No.:64/5/82-
ALC4/2014
Party
Name:SURVIVAL
TECHNOLOGIES
PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00381/AM15/
RLA
File
:03/95/040/00026/AM15/
Lic.No/Date:0310779504
25.04.2014
Defer
Date:28.10.2015
Decision :The committee according decided to defer the case for want of comments from D/o
C&PC (Chemical)
70
Case
No.:41/10/82-
ALC4/2014
Party
Name:VIVIMED
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00955/AM15/
RLA
File
:09/24/040/00028/AM15/
Lic.No/Date:0910059852
25.04.2014
Defer
Date:28.10.2015
Decision :The Committee in light of written provided vide letter No.35011/618/2014-PI (Norms)
dated 08.10.2015 decided to call for actual consumption of all imported inputs duly certified by
Central Excise Authorities and deferred the case.
71
Case
No.:46/10/82-
ALC4/2014
Party
Name:VIVIMED
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00960/AM15/
RLA
File
:09/24/040/00029/AM15/
Lic.No/Date:0910059853
25.04.2014
Defer
Date:28.10.2015
Decision :The committee noted that information called for from the firm is awaited. The committee
according decided to defer the case.
72
Case
No.:51/10/82-
ALC4/2014
Party
Name:VIVIMED
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00965/AM15/
RLA
File
:09/24/040/00039/AM15/
Lic.No/Date:0910059887
28.04.2014
Defer
Date:28.10.2015
Decision :The committee decided to send a copy of application to DC&PC and deferred the case.
73
Case
No.:61/10/82-
ALC4/2014
Party
Name:STERLING
AUXILIARIES PVT LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00975/AM15/
RLA
File
:03/95/040/00913/AM14/
Lic.No/Date:0310779831
29.04.2014
Defer
Date:28.10.2015
Decision :The committee decided to defer the case for want of comments from DC&PC.
74
Case
No.:20/10/82-
ALC4/2014
Party
Name:INCHEM
LABORATORIES PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00934/AM15/
RLA
File
:09/24/040/00044/AM15/
Lic.No/Date:0910059969
01.05.2014
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/105/2015-PI (Norms) dated
October 2015, uploaded along with these minutes or as applied by the firm whichever is less
under
para
4.07
of
HBP
Vol.1.
75
Case
No.:3/5/82-
ALC4/2014
Party
Name:NEW
ALLIANCE
DYE-CHEM
PVT. LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00320/AM15/
RLA
File
:03/95/040/00017/AM15/
Lic.No/Date:0310780255
01.05.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product “ EDTA Trisodium
Trihydrate” based on the recommendation of D/o C&PC provided vide U.O.14010/13/2012-Ch-II
dated 05.10.2015, uploaded along with these minutes or as applied by the firm whichever is less
under
para
4.07
of
HBP
Vol.1.
76
Case
No.:19/10/82-
ALC4/2014
Party
Name:SRINI
PHARMACEUTICALS LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00933/AM15/
RLA
File
:09/24/040/00020/AM15/
Lic.No/Date:0910059967
01.05.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product “ Ramipril” based on the
recommendation of D/o Pharmaceuticals provided vide 35011/87/2015-PI (Norms) dated
11.09.2015, uploaded along with these minutes or as applied by the firm whichever is less under
para
4.07
of
HBP
Vol.1.
77
Case
No.:237/6/82-
ALC4/2014
Party
Name:ESTEEM
INDUSTRIES PVT. LTD,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00639/AM15/
RLA
File
:17/24/040/00002/AM15/
Lic.No/Date:1710005803
05.05.2014
Defer
Date:28.10.2015
Decision :The committee decided to send a copy of application to DC&PC and deferred the case.
78
Case
No.:54/5/82-
ALC4/2014
Party
Name:NEW
ALLIANCE
DYE-CHEM
PVT. LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00371/AM15/
RLA
File
:03/95/040/00077/AM15/
Lic.No/Date:0310780621
05.05.2014
Defer
Date:28.10.2015
Decision :The committee decided to defer the case for want of comments of DoC&PC.
79
Case
No.:44/10/82-
ALC4/2014
Party
Name:MYLAN
LABORATORIES
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00958/AM15/
RLA
File
:09/24/040/00053/AM15/
Lic.No/Date:0910060088
13.05.2014
Defer
Date:28.10.2015
Decision :The committee decided to deferred the case for want of comments of DoP.
80
Case
No.:59/10/82-
ALC4/2014
Party
Name:MYLAN
LABORATORIES
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00973/AM15/
RLA
File
:09/24/040/00045/AM15/
Lic.No/Date:0910060084
13.05.2014
Defer
Date:28.10.2015
Decision :Committee noted that information called for from the firm is still awaited.
81
Case
No.:39/10/82-
ALC4/2014
Party
Name:MYLAN
LABORATORIES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Rejected
HQ
File
:01/82/050/00953/AM15/
RLA
File
:09/24/040/00060/AM15/
Lic.No/Date:0910060145
19.05.2014
Defer Date:
Decision :The Committee decided reject the case based on the written comments provided by
D/o Pharmaceuticals vide letter No.35011/188/2015-PI (Norms) dated August, 2015, uploaded
along with these minutes. RA may take further necessary action as per NC decision.
82
Case
No.:35/10/82-
ALC4/2014
Party
Name:MYLAN
LABORATORIES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00949/AM15/
RLA
File
:09/24/040/00076/AM15/
Lic.No/Date:0910060166
21.05.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Paroxetine
Hydrochloride” based on the recommendation of D/o Pharmaceuticals provided vide
O.M.35011/139/2015-PI (Norms) dated 01.10.2015, uploaded along with these minutes or as
applied
by
the
firm
whichever
is
less
under
para
4.07
of
HBP
Vol.1.
83
Case
No.:36/10/82-
ALC4/2014
Party
Name:MYLAN
LABORATORIES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00950/AM15/
RLA
File
:09/24/040/00072/AM15/
Lic.No/Date:0910060165
21.05.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Clindamycin Palmitate
hydrochloride based on the recommendation of D/o Pharmaceuticals provided vide O.M.35011/177/2015-PI (Norms) dated 29.09.2015, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.
84
Case
No.:79/8/82-
ALC4/2014
Party
Name:BDR
PHARMACEUTICALS
INTERNATIONAL
PVT.
LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00743/AM15/
RLA
File
:03/94/040/00040/AM15/
Lic.No/Date:0310782569
22.05.2014
Defer Date:
Decision :The committee decided to ratify the norms on the basis of earlier decision of NC in its
meeting No.02/82 dated 29.4.2015 as per details uploaded along with these minutes or as applied
by
the
firm
whichever
is
less
under
para
4.07
of
HBP
Vol.1.
85
Case
No.:41/5/82-
ALC4/2014
Party Name:ALMELO PVT
LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00358/AM15/
RLA
File
:09/24/040/00096/AM15/
Lic.No/Date:0910060207
23.05.2014
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/604/2015-PI (Norms) dated
October 2015, uploaded along with these minutes or as applied by the firm whichever is less
under
para
4.07
of
HBP
Vol.1.
86
Case
No.:119/8/82-
ALC4/2014
Party
Name:KUSUMA
PHARMA
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00783/AM15/
RLA
File
:03/94/040/00115/AM15/
Lic.No/Date:0310782930
26.05.2014
Defer Date:
Decision :The Committee decided to ratify norms for the based on the written comments provided
DC&PC vide U.O.No.14010/31/2009-Ch-II dated 11.09.2015, uploaded along with these minutes
or
as
applied
by
the
firm
whichever
is
less
under
para
4.07
of
HBP
Vol.1.
87
Case
No.:29/10/82-
ALC4/2014
Party
Name:MSN
LABORATORIES PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00943/AM15/
RLA
File
:09/24/040/00110/AM15/
Lic.No/Date:0910060235
27.05.2014
Defer Date:
Decision :The Committee decided to ratify norms for the based on the written comments provided
35011/174/2015-PI(Norms) dated 13.10.2015, uploaded along with these minutes or as applied by
the
firm
whichever
is
less
under
para
4.07
of
HBP
Vol.1.
88
Case
No.:13/2/82-
ALC4/2015
Party
Name:JUBILANT
LIFE SCIENCES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00028/AM16/
RLA
File
:05/23/040/00080/AM15/
Lic.No/Date:0510387607
28.05.2014
Defer
Date:28.10.2015
Decision :The committee decided to deferred the case for want of comments of DoP.
89
Case
No.:145/6/82-
ALC4/2014
Party
Name:LAKE
CHEMICALS
PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00547/AM15/
RLA
File
:07/24/040/00003/AM15/
Lic.No/Date:0710104565
28.05.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product 8-CHLORO-6-(2-
FLUOROPHENYL)-1-METHYL-3A,4-DIHYDRO-3H-IMIDAZO[1,5-A][1,4]BENZODIAZEPINE
based on the recommendation of D/o Pharmaceuticals provided vide O.M.35011/249/2015-PI
(Norms) dated 29.09.2015, uploaded along with these minutes or as applied by the firm whichever
is
less
under
para
4.07
of
HBP
Vol.1.
90
Case
No.:38/8/82-
ALC4/2014
Party
Name:MYLAN
LABORATORIES
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00702/AM15/
RLA
File
:09/24/040/00108/AM15/
Lic.No/Date:0910060258
28.05.2014
Defer
Date:28.10.2015
Decision :The committee decided to send copy of application to DoP and deferred the case.
91
Case
No.:51/8/82-
ALC4/2014
Party
Name:PVS
LABORATORIES LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00715/AM15/
RLA
File
:09/24/040/00022/AM15/
Lic.No/Date:0910060267
28.05.2014
Defer
Date:28.10.2015
Decision :The Committee noted that information called for from the firm is awaited.
92
Case
No.:165/6/82-
ALC4/2014
Party
Name:HALDIA
PETROCHEMICALS LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00567/AM15/
RLA
File
:02/24/040/00037/AM15/
Lic.No/Date:0210203844
05.06.2014
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comment of DC&PC.
93
Case
No.:15/8/82-
ALC4/2014
Party Name:ALMELO PVT
LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00679/AM15/
RLA
File
:09/24/040/00119/AM15/
Lic.No/Date:0910060403
09.06.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product “Losartan Potassium”
based on the recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/604/2015-PI
(Norms) dated October 2015, uploaded along with these minutes or as applied by the firm
whichever
is
less
under
para
4.07
of
HBP
Vol.1.
94
Case
No.:48/8/82-
ALC4/2014
Party Name:ALMELO PVT
LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00712/AM15/
RLA
File
:09/24/040/00118/AM15/
Lic.No/Date:0910060402
09.06.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product “Losartan Potassium” based on the recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/604/2015-PI (Norms) dated October 2015, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.
95
Case
No.:106/8/82-
ALC4/2014
Party
Name:BAYER
CROPSCIENCE LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00770/AM15/
RLA
File
:03/94/040/00131/AM15/
Lic.No/Date:0310785223
12.06.2014
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments of DC&PC.
96
Case
No.:60/10/82-
ALC4/2014
Party
Name:BIO-TECH
OPHTHALMICS
PVT.
LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00974/AM15/
RLA
File
:08/24/040/00116/AM15/
Lic.No/Date:0810132332
13.06.2014
Defer
Date:28.10.2015
Decision : Reply of the firm received and send to DoP on 24.09.2015. It was decided to defer the
case for want of comments of DC&PC.
97
Case
No.:77/8/82-
ALC4/2014
Party
Name:BENZO
CHEM
INDUSTRIES
PRIVATE LIMITED,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00741/AM15/
RLA
File
:03/94/040/00196/AM15/
Lic.No/Date:0310785501
17.06.2014
Defer
Date:28.10.2015
Decision :: The Committee decided to defer the case for want of comments of D/o C&PC
(Chemical) .
98
Case
No.:30/8/82-
ALC4/2014
Party
Name:INDIAN
IMMUNOLOGICALS
LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00694/AM15/
RLA
File
:09/24/040/00135/AM15/
Lic.No/Date:0910060470
17.06.2014
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments of DBT.
99
Case
No.:20/8/82-
ALC4/2014
Party
Name:SRINI
PHARMACEUTICALS
LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00684/AM15/
RLA
File
:09/24/040/00139/AM15/
Lic.No/Date:0910060467
17.06.2014
Defer
Date:28.10.2015
Decision :The Committee noted that information called for from the firm is awaited. The
committee decided to await the reply and deferred the case.
100
Case
No.:19/8/82-
ALC4/2014
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00683/AM15/
RLA
File
:09/24/040/00153/AM15/
Lic.No/Date:0910060486
18.06.2014
Defer
Date:28.10.2015
Decision :The Committee noted that information called for from the firm is awaited. The
committee decided to await the reply and deferred the case.
101
Case
No.:83/18/82-
ALC4/2014
Party
Name:INDIAN
IMMUNOLOGICALS
LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01449/AM15/
RLA
File
:09/24/040/00136/AM15/
Lic.No/Date:0910060517
20.06.2014
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments from DBT.
102
Case
No.:111/8/82-
ALC4/2014
Party
Name:THINQ
PHARMA-CRO LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00775/AM15/
RLA
File
:03/95/040/00178/AM15/
Lic.No/Date:0310785804
23.06.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product “Ractopamine HCL”
based on the recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/105/2015-PI
(Norms) dated October 2015, uploaded along with these minutes or as applied by the firm
whichever
is
less
under
para
4.07
of
HBP
Vol.1.
103
Case
No.:85/9/82-
ALC4/2014
Party
Name:BLISS
GVS
PHARMA LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00882/AM15/
RLA
File
:03/94/040/00178/AM15/
Lic.No/Date:0310786049
26.06.2014
Defer Date:
recommendation of D/o Pharmaceuticals forwarded vide O.M. No. 35011/56/2015-PI(Norms)
dated 14.09.2015 , uploaded along with these minutes or as applied by the firm whichever is less
under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.
104
Case
No.:52/8/82-
ALC4/2014
Party
Name:LAKE
CHEMICALS
PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00716/AM15/
RLA
File
:07/24/040/00096/AM15/
Lic.No/Date:0710105418
26.06.2014
Defer
Date:28.10.2015
Decision :The Committee decided to send copy of application to doP and deferred the case for
want of comments.
105
Case
No.:74/9/82-
ALC4/2014
Party
Name:BLISS
GVS
PHARMA LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00871/AM15/
RLA
File
:03/94/040/00277/AM15/
Lic.No/Date:0310786144
27.06.2014
Defer Date:
recommendation of D/o Pharmaceuticals forwarded vide O.M. No. 35011/56/2015-PI(Norms)
dated 14.09.2015 , uploaded along with these minutes or as applied by the firm whichever is less
under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.
106
Case
No.:63/10/82-
ALC4/2014
Party
Name:SAVVY
CARE
&
COSMETICS
PVT LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00977/AM15/
RLA
File
:03/95/040/00254/AM15/
Lic.No/Date:0310786114
27.06.2014
Defer
Date:28.10.2015
Decision :The Committee noted that information called for from the firm is awaited.
107
Case
No.:199/6/82-
ALC4/2014
Party
Name:H.J.AROCHEM
PVT. LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00601/AM15/
RLA
File
:08/24/040/00569/AM14/
Lic.No/Date:0810132520
30.06.2014
Defer
Date:28.10.2015
Decision :The committee decided to send copy of application to DC&PC and deferred the case.
108
Case
No.:202/6/82-
ALC4/2014
Party
Name:FORACE
POLYMERS (P) LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00604/AM15/
RLA
File
:05/23/040/00139/AM15/
Lic.No/Date:0510389232
01.07.2014
Defer
Date:28.10.2015
Decision :The committee decided to defer the case for want of comments from D/o C&PC
(Petrochemical) ..
109
Case
No.:83/8/82-
ALC4/2014
Party Name:MANGALAM
ORGANICS
LIMITED
(FORMERLY
DUJODWALA
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00747/AM15/
RLA
File
:03/95/040/00109/AM15/
Lic.No/Date:0310786418
04.07.2014
Defer
Date:28.10.2015
Decision :The committee noted that information called for from the firm is awaited.
110
Case
No.:28/10/82-
ALC4/2014
Party
Name:GLOCHEM
INDUSTRIES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00942/AM15/
RLA
File
:09/24/040/00143/AM15/
Lic.No/Date:0910060609
08.07.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Levodopa based on the
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/88/2015-PI (Norms) dated
11.09.2015 , uploaded along with these minutes or as applied by the firm whichever is less under
para
4.07
of
HBP
Vol.1.
111
Case
No.:62/10/82-
ALC4/2014
Party
Name:STERLING
AUXILIARIES PVT LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00976/AM15/
RLA
File
:03/95/040/00271/AM15/
Lic.No/Date:0310786523
08.07.2014
Defer
Date:28.10.2015
Decision :The committee decided to defer the case for want of comments from DC&PC.
112
Case
No.:44/15/82-
ALC4/2014
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01331/AM15/
RLA
File
:09/24/040/00192/AM15/
Lic.No/Date:0910060635
09.07.2014
Defer
Date:28.10.2015
Decision :The Committee decided to call for information based on the recommendation of D/o
Pharmaceuticals provided vide O.M.No.35011/144/2015-PI (Norms) dated 1.10.2015 , uploaded
along with these minutes and deferred the case.
113
Case
No.:200/6/82-
ALC4/2014
Party
Name:PANACEA
BIOTEC LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00602/AM15/
RLA
File
:05/24/040/00168/AM15/
Lic.No/Date:0510389734
16.07.2014
Defer
Date:28.10.2015
Decision :The committee decided to defer the case for want of comments from DBT.
114
Case
No.:72/10/82-
ALC4/2014
Party
Name:GLOBAL
CALCIUM
PRIVATE
LIMITED,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00986/AM15/
RLA
File
:07/24/040/00112/AM15/
Lic.No/Date:0710105884
18.07.2014
Defer
Date:28.10.2015
Decision :The committee decided to defer the case for want of comments from D/o C&PC
(Chemical) .
115
Case
No.:70/8/82-
ALC4/2014
Party
Name:SHANPAR
INDUSTRIES PVT. LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00734/AM15/
RLA
File
:34/24/040/00097/AM15/
Lic.No/Date:3410040385
21.07.2014
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/254/2015-PI (Norms)
dated September 2015, uploaded along with these minutes or as applied by the firm whichever is
less
under
para
4.07
of
HBP
Vol.1.
116
Case
No.:25/15/82-
ALC4/2014
Party
Name:SHIVAM
OILS
&
PROTEINS
INDUSTRY,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01312/AM15/
RLA
File
:56/24/040/00019/AM15/
Lic.No/Date:5610004338
22.07.2014
Defer
Date:28.10.2015
Decision :The committee noted that information called for from the firm is awaited and decided
to defer the case.
117
Case
No.:71/8/82-
ALC4/2014
Party
Name:ALEMBIC
PHARMACEUTICALS
LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00735/AM15/
RLA
File
:34/24/040/00099/AM15/
Lic.No/Date:3410040394
23.07.2014
Defer
Date:28.10.2015
Decision :The Committee noted that information called for from the firm is awaited.
118
Case
No.:14/9/82-
ALC4/2014
Party
Name:GLAND
PHARMA LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00811/AM15/
RLA
File
:09/24/040/00219/AM15/
Lic.No/Date:0910060797
04.08.2014
Defer
Date:28.10.2015
Decision :The committee decided to defer the case for want of comments from DoP
119
Case
No.:66/8/82-
ALC4/2014
Party
Name:RECKITT
BENCKISER
HEALTHCARE
INDIA
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00730/AM15/
RLA
File
:05/24/040/00205/AM15/
Lic.No/Date:0510390158
06.08.2014
Defer
Date:28.10.2015
Decision :The Committee noted that information called for from the firm is awaited.
120
Case
No.:18/15/82-
ALC4/2014
Party
Name:SHASUN
PHARMACEUTICALS
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01305/AM15/
RLA
File
:04/24/040/00127/AM15/
Lic.No/Date:0410159222
13.08.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product metoprolol Tartrate
Tablets 100mg based on the recommendation of D/o Pharmaceuticals provided vide
O.M.No.35011/126/2015-PI (Norms) dated 05.10.2015 , uploaded along with these minutes or as
applied
by
the
firm
whichever
is
less
under
para
4.07
of
HBP
Vol.1.
121
Case
No.:37/9/82-
ALC4/2014
Party Name:JAGSONPAL
PHARMACEUTICALS
LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00834/AM15/
RLA
File
:05/23/040/00198/AM15/
Lic.No/Date:0510390634
21.08.2014
Defer
Date:28.10.2015
Decision :The committee decided to defer the case for want of comments from DoP
122
Case
No.:242/13/82-
ALC4/2014
Party Name:HINDUSTAN
POLYAMIDES & FIBRES
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01245/AM15/
RLA
File
:03/94/040/00442/AM15/
Lic.No/Date:0310788283
22.08.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Cyclamen Aldehyde
Pure based on the recommendation of D/o C&PC, provided vide U.O.No.14010/90/2011-Ch-II
dated 10.09.2015 , uploaded along with these minutes or as applied by the firm whichever is less
under para 4.07 of HBP Vol.1. RA may take further action accordingly.
123
Case
No.:35/9/82-
ALC4/2014
Party
Name:CADILA
HEALTHCARE LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00832/AM15/
RLA
File
:08/24/040/00203/AM15/
Lic.No/Date:0810133097
25.08.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product based on the recommendation of
D/o Pharmaceuticals provided vide O.M.No.35011/598/2014-PI (Norms) dated 16.03.2015, uploaded along
with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.
124
Case
No.:36/9/82-
ALC4/2014
Party
Name:CADILA
HEALTHCARE LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00833/AM15/
RLA
File
:08/24/040/00202/AM15/
Lic.No/Date:0810133096
25.08.2014
Defer
Date:28.10.2015
Decision :: The committee decided to defer the case for want of comments from DoP
125
Case
No.:17/15/82-
ALC4/2014
Party
Name:SURVIVAL
TECHNOLOGIES
PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01304/AM15/
RLA
File
:03/95/040/00428/AM15/
Lic.No/Date:0310788314
25.08.2014
Defer
Date:28.10.2015
Decision : The committee decided to defer the case for want of comments from DoP.
126
Case
No.:37/7/82-
ALC4/2015
Party
Name:DR
J
PHARMACHEM
(INDIA)(PROP.ADITYA
PRAMOD JOGDEO)
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00642/AM16/
RLA
File
:31/83/040/00125/AM15/
Lic.No/Date:3110064792
28.08.2014
Defer
Date:28.10.2015
Decision :The committee decided to call for copy of COA of import items from foreign supplier
and export item and deferred the case.
127
Case
No.:254/13/82-
ALC4/2014
Party
Name:SEQUENT
SCIENTIFIC LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01257/AM15/
RLA
File
:03/95/040/00459/AM15/
Lic.No/Date:0310788513
28.08.2014
Defer
Date:28.10.2015
Decision :The Committee decided to call for information for the export product Clozasole based
on the recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/61/2015-PI
(Norms) dated 11.09.2015, uploaded along with these minutes and deferred the case.
128
Case
No.:54/13/82-
ALC4/2014
Party
Name:RA
CHEM
PHARMA LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01057/AM15/
RLA
File
:09/24/040/00272/AM15/
Lic.No/Date:0910060900
01.09.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Ractopamine Hcl based
on the recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/99/2015-PI
(Norms) dated 11.09.2015 , uploaded along with these minutes or as applied by the firm
whichever
is
less
under
para
4.07
of
HBP
Vol.1.
129
Case
No.:217/13/82-
ALC4/2014
Party
Name:ENCUBE
ETHICALS PVT LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01220/AM15/
RLA
File
:03/94/040/00494/AM15/
Lic.No/Date:0310788620
02.09.2014
Defer
Date:28.10.2015
Decision :The Committee noted that information called for from the firm is awaited. The
Committee accordingly decided to await the reply and deferred the case.
130
Case
No.:55/15/82-
ALC4/2014
Party
Name:COVALENT
LABORATORIES PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01342/AM15/
RLA
File
:09/24/040/00274/AM15/
Lic.No/Date:0910060921
05.09.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Cefprozil based on the
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/142/2015-PI (Norms)
dated 01.10.2015 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.
131
Case
No.:22/13/82-
ALC4/2014
Party Name:MANGALAM
ORGANICS
LIMITED
(FORMERLY
DUJODWALA
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01025/AM15/
RLA
File
:03/95/040/00379/AM15/
Lic.No/Date:0310788810
05.09.2014
Defer
Date:28.10.2015
Decision :The committee decided to defer the case for want of comments from D/o C&PC
(Chemical) .
132
Case
No.:196/13/82-
ALC4/2014
Party
Name:KOPRAN
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01199/AM15/
RLA
File
:03/94/040/00545/AM15/
Lic.No/Date:0310788934
09.09.2014
Defer
Date:28.10.2015
Decision :The Committee in light of comment of D/o Pharmaceuticals forwarded vile
O.M.No.35011/101/2015-PI(Norms) dated 29th July, 2015 decided to call for following
information
from
the
firm:-
a)
Complete
technical
details
as
per
Appendix-33.
Past production vis-à-vis Actual consumption of all the imported inputs duly certified by Central
excise Authorities.
133
Case
No.:201/13/82-
ALC4/2014
Party
Name:KRISHNA
ANTIOXIDANTS
PVT.
LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01204/AM15/
RLA
File
:03/94/040/00499/AM15/
Lic.No/Date:0310788928
09.09.2014
Defer
Date:28.10.2015
Decision :In the light of written comments received from D/o C&PC vide their OM
No.14010/100/2012 Ch.II 02.06.2015, it was decided to call for following information from the
firm:-
- Detailed production of export product under reference in the year 2014-15 and corresponding consumption of raw-materials duly certified by CA
- Basis of applied quantity of raw materials including authentic printed literature in support of the quantity raw material. 3.Any other relevant information.
134
Case
No.:27/13/82-
ALC4/2014
Party
Name:STERLING
AUXILIARIES PVT LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01030/AM15/
RLA
File
:03/95/040/00494/AM15/
Lic.No/Date:0310788943
09.09.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments of D/o C&PC (Petrochemical)
135
Case
No.:23/13/82-
ALC4/2014
Party
Name:YASHO
INDUSTRIES PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01026/AM15/
RLA
File
:03/95/040/00496/AM15/
Lic.No/Date:0310788911
09.09.2014
Defer
Date:28.10.2015
Decision :: It was decided to defer the case for want of comments of D/o C&PC (Chemical) .
136
Case
No.:250/13/82-
ALC4/2014
Party
Name:YASHO
INDUSTRIES PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01253/AM15/
RLA
File
:03/95/040/00490/AM15/
Lic.No/Date:0310788892
09.09.2014
Defer
Date:28.10.2015
Decision :: It was decided to defer the case for want of comments of D/o C&PC (Chemical) .
137
Case
No.:62/13/82-
ALC4/2014
Party Name:EYTAN LABS
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01065/AM15/
RLA
File
:09/24/040/00257/AM15/
Lic.No/Date:0910060924
10.09.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product (2R-Cis)-4-amino-1-[2-
(hydroxymethyl)-1,3-oxathiolan-5-yl]-2(1H)-pyrimidinone monosalicylate monohydrate based on
the recommendation of D/o Pharmaceuticals provided vide O.M.no.35011/83/2015-PI (Norms)
dated 11.09.2015 , uploaded along with these minutes or as applied by the firm whichever is less
under
para
4.07
of
HBP
Vol.1.
138
Case
No.:53/13/82-
ALC4/2014
Party
Name:MYLAN
LABORATORIES
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01056/AM15/
RLA
File
:09/24/040/00240/AM15/
Lic.No/Date:0910060930
10.09.2014
Defer
Date:28.10.2015
Decision :The Committee in light of comment of D/o Pharmaceuticals forwarded vide
O.M.No.35011/197/2015-PI(Norms) dated 24th July, 2015 decided to call for following
information from the firm:-
a) Complete technical details as per Appendix-33 showing % yield on molar basis for each step
of manufacturing process
Past production vis-à-vis Actual consumption of all the imported inputs duly certified by Central
excise Authorities.
139
Case
No.:64/13/82-
ALC4/2014
Party
Name:MYLAN
LABORATORIES
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01067/AM15/
RLA
File
:09/24/040/00247/AM15/
Lic.No/Date:0910060929
10.09.2014
Defer
Date:28.10.2015
Decision :The committee considered the case and deferred the case for want of comments from
D/o Pharmaceuticals.
140
Case
No.:197/13/82-
ALC4/2014
Party
Name:KOPRAN
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01200/AM15/
RLA
File
:03/94/040/00547/AM15/
Lic.No/Date:0310789054
11.09.2014
Defer
Date:28.10.2015
Decision :The Committee in light of comment of D/o Pharmaceuticals forwarded vile
O.M.No.35011/101/2015-PI(Norms) dated 29th July, 2015 decided to call for following
information from the firm:-
a) Complete technical details as per Appendix-33.
Past production vis-à-vis Actual consumption of all the imported inputs duly certified by Central
excise Authorities
141
Case
No.:45/15/82-
ALC4/2014
Party
Name:GLAND
PHARMA LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01332/AM15/
RLA
File
:09/24/040/00305/AM15/
Lic.No/Date:0910060957
12.09.2014
Defer
Date:28.10.2015
D/o Pharmaceuticals.
142
Case
No.:4/8/82-
ALC4/2014
Party
Name:HONOUR
LAB LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00668/AM15/
RLA
File
:09/24/040/00318/AM15/
Lic.No/Date:0910060963
12.09.2014
Defer
Date:28.10.2015
Decision : The Committee noted that information call for from the is awaited.
143
Case
No.:6/8/82-
ALC4/2014
Party
Name:HONOUR
LAB LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00670/AM15/
RLA
File
:09/24/040/00314/AM15/
Lic.No/Date:0910060964
12.09.2014
Defer
Date:28.10.2015
Decision : The Committee noted that information call for from the is awaited.
144
Case
No.:8/8/82-
ALC4/2014
Party
Name:HONOUR
LAB LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00672/AM15/
RLA
File
:09/24/040/00315/AM15/
Lic.No/Date:0910060966
12.09.2014
Defer
Date:28.10.2015
Decision :Committee decided to send a copy of application to DCPC and defer the case.
145
Case
No.:65/13/82-
ALC4/2014
Party
Name:MSN
LABORATORIES PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01068/AM15/
RLA
File
:09/24/040/00283/AM15/
Lic.No/Date:0910060955
12.09.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Abiraterone Acetate
based on the recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/174/2015-PI
(Norms) dated October 2015, uploaded along with these minutes or as applied by the firm
whichever
is
less
under
para
4.07
of
HBP
Vol.1.
146
Case
No.:28/13/82-
ALC4/2014
Party
Name:TITAN
LABORATORIES
PVT.
LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01031/AM15/
RLA
File
:03/95/040/00398/AM15/
Lic.No/Date:0310789099
12.09.2014
Defer
Date:28.10.2015
Decision :The Committee decided to call for information as per written comments of D/o
Pharmaceuticals provided vide O.M.No.35011/63/2015-PI (Norms) dated 11.09.2015 , uploaded
along with these minutes and deferred the case.
147 Case
No.:188/13/82-
ALC4/2014
Party
Name:DELTA
FINOCHEM PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
Status:Case
Deferred
30.09.2015
HQ
File
:01/82/050/01191/AM15/
RLA
File
:03/94/040/00102/AM15/
Lic.No/Date:0310789322
17.09.2014
Defer
Date:28.10.2015
of D/o C&PC (Chemical)
148
Case
No.:38/15/82-
ALC4/2014
Party
Name:SALICYLATES
&
CHEMICALS
PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01325/AM15/
RLA
File
:09/24/040/00250/AM15/
Lic.No/Date:0910060988
17.09.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Sodium Salicylate
based on the recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/225/2015-PI
(Norms) dated 07.10.2015 , uploaded along with these minutes or as applied by the firm
whichever
is
less
under
para
4.07
of
HBP
Vol.1.
149
Case No.:13/8/82-ALC4/2014 Party Name:HETERO LABS
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00677/AM15/
RLA
File
:09/24/040/00324/AM15/
Lic.No/Date:0910060989
17.09.2014
Defer Date:
Decision : The Committee decided to ratify norms for the export product based on the
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/144/2015-PI (Norms)
dated 01.10.2015 , uploaded along with these minutes or as applied by the firm whichever is less
under
para
4.07
of
HBP
Vol.1.
150
Case
No.:57/13/82-
ALC4/2014
Party
Name:HELLO
PAINTS (P) LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01060/AM15/
RLA
File
:05/23/040/00277/AM15/
Lic.No/Date:0510391246
19.09.2014
Defer
Date:28.10.2015
of D/o C&PC (Chemical).
151
Case
No.:59/13/82-
ALC4/2014
Party
Name:HELLO
PAINTS (P) LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01062/AM15/
RLA
File
:05/23/040/00276/AM15/
Lic.No/Date:0510391245
19.09.2014
Defer
Date:30.09.2015
of D/o C&PC (Chemical)
152
Case
No.:125/8/82-
ALC4/2014
Party
Name:HETERO
DRUGS LIMITED,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00789/AM15/
RLA
File
:09/24/040/00345/AM15/
Lic.No/Date:0910061000
19.09.2014
Defer
Date:28.10.2015
Decision :The Committee decided call for information based on the recommendation of D/o
Pharmaceuticals provided vide O.M.No.35011/143/2015-PI (Norms) dated October 2015, uploaded along with these minutes and deferred the case.
153
Case
No.:9/15/82-
ALC4/2014
Party
Name:VIRCHOW
BIOTECH PV T LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01296/AM15/
RLA
File
:09/24/040/00327/AM15/
Lic.No/Date:0910061001
19.09.2014
Defer
Date:28.10.2015
DBT.
154
Case
No.:60/15/82-
ALC4/2014
Party
Name:CLEAN
SCIENCE
AND
TECHNOLOGY
PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01347/AM15/
RLA
File
:31/83/040/00136/AM15/
Lic.No/Date:3110064915
22.09.2014
Defer
Date:28.10.2015
of D/o C&PC (Chemical)
155
Case
No.:128/8/82-
ALC4/2014
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00792/AM15/
RLA
File
:09/24/040/00341/AM15/
Lic.No/Date:0910061003
22.09.2014
Defer
Date:28.10.2015
Decision :The Committee decided to call for information based on the recommendation of D/o
Pharmaceuticals provided vide O.M.No.35011/145/2015-PI (Norms) dated September 2015,
uploaded along with these minutes and deferred the case.
156
Case
No.:129/8/82-
ALC4/2014
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00793/AM15/
RLA
File
:09/24/040/00338/AM15/
Lic.No/Date:0910061004
22.09.2014
Defer
Date:28.10.2015
Decision
:The
committee
in
light
of
written
comments
provided
by
DoP
vide
O.M.35011/195/2015-PI(Norms) uploaded along with these minutes decided call for information
from the firm.
157
Case
No.:130/8/82-
ALC4/2014
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00794/AM15/
RLA
File
:09/24/040/00332/AM15/
Lic.No/Date:0910061005
22.09.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Aripiprazole based on
the recommendation of D/o Pharmaceuticals provided vide O.M. No.35011/190/2015 –PI(Norms)
dated 5.10.2015, uploaded along with these minutes or as applied by the firm whichever is less
under
para
4.07
of
HBP
Vol.1.
158
Case
No.:17/13/82-
ALC4/2014
Party
Name:GRASIM
INDUSTRIES LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01020/AM15/
RLA
File
:34/24/040/00155/AM15/
Lic.No/Date:3410040570
23.09.2014
Defer
Date:28.10.2015
D/o C&PC.
159
Case
No.:115/13/82-
ALC4/2014
Party
Name:WEST
BENGAL
CHEMICAL
INDUSTRIES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01118/AM15/
RLA
File
:02/24/040/00097/AM15/
Lic.No/Date:0210205008
23.09.2014
Defer
Date:28.10.2015
of D/o C&PC (Chemical)
160
Case
No.:74/13/82-
ALC4/2014
Party Name:CONSTECH
ENTERPRISES
PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01077/AM15/
RLA
File
:05/23/040/00282/AM15/
Lic.No/Date:0510391308
24.09.2014
Defer
Date:28.10.2015
of D/o C&PC (Chemical)
161
Case
No.:30/13/82-
ALC4/2014
Party
Name:R
L
FINE
CHEM
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01033/AM15/
RLA
File
:07/24/040/00218/AM15/
Lic.No/Date:0710106755
24.09.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Orphenadrine Citrate
BP/EP/USP based on the recommendation
of D/o Pharmaceuticals provided vide
O.M.No.35011/203/2015-PI(Norms) dated 16.09.2015 , uploaded along with these minutes or as
applied
by
the
firm
whichever
is
less
under
para
4.07
of
HBP
Vol.1.
162
Case
No.:9/2/82-
ALC4/2015
Party
Name:JUBILANT
GENERICS LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00024/AM16/
RLA
File
:05/23/040/00261/AM15/
Lic.No/Date:0510391358
26.09.2014
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments of DoP.
163
Case
No.:21/13/82-
ALC4/2014
Party
Name:JUBILANT
GENERICS LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01024/AM15/
RLA
File
:05/23/040/00260/AM15/
Lic.No/Date:0510391357
26.09.2014
Defer
Date:28.10.2015
Decision :The Committee decided to call for information based on the recommendation of D/o
Pharmaceuticals provided vide 35011/288/2015-PI dated 7.10.2015 , uploaded along with these
minutes and deferred the case.
164
Case
No.:148/13/82-
ALC4/2014
Party
Name:MICRO
LABS
LTD
Meet
No/Date:9/82-
ALC4/2015
Status:Case
Approved
30.09.2015
HQ
File
:01/82/050/01151/AM15/
RLA
File
:07/24/040/00208/AM15/
Lic.No/Date:0710106752
24.09.2014
Defer Date:
Decision : The Committee decided to ratify norms for the export product based on the
recommendation of D/o Pharmaceuticals, provided vide U.O.No. 35011/52/2015-PI(Norms) dated
14.9.2015 , uploaded along with these minutes or as applied by the firm whichever is less under
para
4.07
of
HBP
Vol.1.
165
Case
No.:192/13/82-
ALC4/2014
Party
Name:INDOFIL
INDUSTRIES LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01195/AM15/
RLA
File
:03/94/040/00539/AM15/
Lic.No/Date:0310789636
24.09.2014
Defer Date:
Decision : The Committee decided to ratify norms for the export product “Cymoxanil Technical”
based on the recommendation of D/o C&PC provided vide U.O.No.15022/17/2012-Ch-II dated
05.10.2015, uploaded along with these minutes or as applied by the firm whichever is less under
para
4.07
of
HBP
Vol.1.
166
Case
No.:50/13/82-
ALC4/2014
Party
Name:PAYAL
PETROCHEM
PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01053/AM15/
RLA
File
:05/24/040/00211/AM15/
Lic.No/Date:0510391368
26.09.2014
Defer Date:
recommendation of D/o C&PC, provided vide U.O.No.14010/18/2014-Ch-II dated 2.9.2015 ,
uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of
HBP
Vol.1.
167
Case
No.:51/13/82-
ALC4/2014
Party
Name:PAYAL
PETROCHEM
PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01054/AM15/
RLA
File
:05/24/040/00444/AM14/
Lic.No/Date:0510391367
26.09.2014
Defer Date:
HBP
Vol.1.
168
Case
No.:52/13/82-
ALC4/2014
Party
Name:PAYAL
PETROCHEM
PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01055/AM15/
RLA
File
:05/24/040/00231/AM15/
Lic.No/Date:0510391369
26.09.2014
Defer Date:
HBP
Vol.1.
169
Case
No.:49/13/82-
ALC4/2014
Party
Name:SENTISS
PHARMA PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01052/AM15/
RLA
File
:05/24/040/00284/AM15/
Lic.No/Date:0510391389
26.09.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product “Bromfenac Eye Drops”
based on the recommendation of D/o Pharmaceuticals, provided vide O.M.No. 35011/129/2015-
PI (Norms) dated 5.10.2015 , uploaded along with these minutes or as applied by the firm
whichever
is
less
under
para
4.07
of
HBP
Vol.1.
170
Case
No.:2/9/82-
ALC4/2014
Party
Name:PERKIN
LABORATORIES
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00799/AM15/
RLA
File
:09/24/040/00358/AM15/
Lic.No/Date:0910061044
29.09.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product “2,3 Dibromo-5-Benzoyl
Pyrrole” based on the recommendation of D/o Pharmaceuticals, provided vide O.M.No.
35011/221/2015-PI (Norms) dated 7.10.2015 , uploaded along with these minutes or as applied
by
the
firm
whichever
is
less
under
para
4.07
of
HBP
Vol.1.
171
Case
No.:19/13/82-
ALC4/2014
Party
Name:SANO
MEDICAL
KITS
PVT.
LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01022/AM15/
RLA
File
:04/24/040/00171/AM15/
Lic.No/Date:0410159504
29.09.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for 20.05.2015 for comments of DBT.
172
Case
No.:178/13/82-
ALC4/2014
Party
Name:HINDUSTAN
POLYAMIDES & FIBRES
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01181/AM15/
RLA
File
:03/94/040/00602/AM15/
Lic.No/Date:0310789838
30.09.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product “Phenyl Ethyl Alcohol /
2-Phenyl Ethyl Alcohol/Beta Phenyl Ethyl Alcohol” based on the recommendation of D/o C&PC,
provided vide U.O.No.14010/90/2011-Ch-II dated 10.9.2015 , uploaded along with these minutes
or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.
173
Case
No.:177/13/82-
ALC4/2014
Party
Name:KRISHNA
ANTIOXIDANTS
PVT.
LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01180/AM15/
RLA
File
:03/94/040/00586/AM15/
Lic.No/Date:0310789849
30.09.2014
Defer
Date:28.10.2015
Decision :: It was decided to defer the case for 20.05.2015 for comments of Department of
C&PC.
174 Case
No.:15/13/82-
ALC4/2014
Party
Name:TATVA
CHINTAN
PHARMA
Meet
No/Date:9/82-
ALC4/2015
Status:Case
Deferred
CHEM PVT LTD
30.09.2015
HQ
File
:01/82/050/01018/AM15/
RLA
File
:34/24/040/00161/AM15/
Lic.No/Date:3410040594
30.09.2014
Defer
Date:28.10.2015
Decision :: It was decided to defer the case for 20.05.2015 for comments of of D/o C&PC
(Chemical)
175
Case
No.:157/13/82-
ALC4/2014
Party
Name:AVA
CHEMICALS PVT.LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01160/AM15/
RLA
File
:03/94/040/00603/AM15/
Lic.No/Date:0310789905
01.10.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Disodium Manganese
EDTA content 6% (+/- 0.5%) As mg. based on the recommendation of D/o C&PC, provided vide
U.O.No.14010/67/2011-Ch-II dated 2.9.2015 , uploaded along with these minutes or as applied
by
the
firm
whichever
is
less
under
para
4.07
of
HBP
Vol.1.
176
Case
No.:29/18/82-
ALC4/2014
Party
Name:CAMPHOR
& ALLIED PRODUCTS
LIMITED,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01395/AM15/
RLA
File
:03/94/040/00596/AM15/
Lic.No/Date:0310789917
01.10.2014
Defer
Date:28.10.2015
Decision :: It was decided to defer the case for 20.05.2015 for comments of of D/o C&PC
(Chemical)
177
Case
No.:19/1/82-
ALC4/2015
Party
Name:GEM
AROMATICS PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01545/AM15/
RLA
File
:03/94/040/00594/AM15/
Lic.No/Date:0310789922
01.10.2014
Defer
Date:28.10.2015
Decision :: It was decided to defer the case for 20.05.2015 for comments of of D/o C&PC
(Chemical)
178
Case
No.:77/13/82-
ALC4/2014
Party
Name:MALLADI
DRUGS
&
PHARMACEUTICALS
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01080/AM15/
RLA
File
:04/24/040/00164/AM15/
Lic.No/Date:0410159520
01.10.2014
Defer
Date:28.10.2015
Decision :The Committee in light of written provided vide letter No.35011/184/2015-PI (Norms)
dated 11.09.2015 , uploaded along with these minutes decided to call for information from the
firm and deferred the case.
179
Case
No.:160/13/82-
ALC4/2014
Party
Name:BAYER
CROPSCIENCE LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01163/AM15/
RLA
File
:03/94/040/00544/AM15/
Lic.No/Date:0310789976
07.10.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for 20.05.2015 for comments of of D/o C&PC
(Chemical)
180
Case
No.:5/9/82-
ALC4/2014
Party
Name:HETERO
DRUGS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00802/AM15/
RLA
File
:09/24/040/00362/AM15/
Lic.No/Date:0910061060
07.10.2014
Defer
Date:28.10.2015
Decision :The Committee noted that information called for from the firm is awaited.
181
Case
No.:182/13/82-
ALC4/2014
Party
Name:AVA
CHEMICALS PVT.LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01185/AM15/
RLA
File
:03/94/040/00626/AM15/
Lic.No/Date:0310790001
08.10.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product EDTA Tetra Ammonium
Liquid Assay Min 40% based on the recommendation of D/o C&PC, provided vide
U.O.No.14010/67/2011-Ch-II dated 20.9.2015 , uploaded along with these minutes or as applied
by
the
firm
whichever
is
less
under
para
4.07
of
HBP
Vol.1.
182
Case
No.:104/9/82-
ALC4/2014
Party
Name:NEULAND
LABORATORIES LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00901/AM15/
RLA
File
:09/24/040/00319/AM15/
Lic.No/Date:0910061076
10.10.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Ramipril based on the
recommendation of D/o Pharmaceuticals, provided vide 35011/132/2015-PI (Norms) dated
29.9.2015 , uploaded along with these minutes or as applied by the firm whichever is less under
para
4.07
of
HBP
Vol.1.
183
Case
No.:87/4/82-
ALC4/2015
Party
Name:ESTEEM
INDUSTRIES PVT. LTD,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00126/AM16/
RLA
File
:17/24/040/00088/AM15/
Lic.No/Date:1710005934
08.10.2014
Defer Date:
recommendation of D/o C&PC, provided vide U.O.No.14010/78/2012-Ch-II dated 3.9.2015 ,
HBP
Vol.1.
184
Case
No.:35/13/82-
ALC4/2014
Party
Name:JUBILANT
LIFE
SCIENCES
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01038/AM15/
RLA
File
:05/23/040/00218/AM15/
Lic.No/Date:0510391491
08.10.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for 20.05.2015 for comments of of D/o C&PC
(Chemical)
185
Case
No.:46/15/82-
ALC4/2014
Party
Name:PORUS
LABORATORIES
PVT
LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File RLA
File Lic.No/Date:0910061072 Defer
:01/82/050/01333/AM15/ :09/24/040/00372/AM15/ 09.10.2014 Date:28.10.2015 Decision :The Committee decided to send the copy of application to D/o C&PC.
186
Case
No.:146/13/82-
ALC4/2014
Party
Name:RECKITT
BENCKISER
HEALTHCARE
INDIA
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01149/AM15/
RLA
File
:05/24/040/00304/AM15/
Lic.No/Date:0510391511
09.10.2014
Defer Date:
recommendation of D/o Pharmaceuticals, provided vide 35011/113/2015-PI (Norms) dated
11.9.2015 , uploaded along with these minutes or as applied by the firm whichever is less under
para
4.07
of
HBP
Vol.1.
187
Case
No.:76/13/82-
ALC4/2014
Party
Name:CAPLIN
POINT LABORATORIES
LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01079/AM15/
RLA
File
:04/24/040/00163/AM15/
Lic.No/Date:0410159566
13.10.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for comments of Department of Pharmaceuticals.
188
Case
No.:140/13/82-
ALC4/2014
Party
Name:MICRO
LABS LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01143/AM15/
RLA
File
:07/24/040/00228/AM15/
Lic.No/Date:0710106816
13.10.2014
Defer
Date:28.10.2015
Decision :The Committee decided ratify norms as per SION – A-54 or as applied by the firm
whichever is less. RA concerned may take further necessary action as per decision of NC.
189
Case
No.:184/13/82-
ALC4/2014
Party
Name:J.B.
CHEMICALS
&
PHARMACEUTICALS
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01187/AM15/
RLA
File
:03/94/040/00675/AM15/
Lic.No/Date:0310790237
14.10.2014
Defer
Date:28.10.2015
Decision :Information called for from the firm is awaited. The Committee accordingly decided to
defer the case.
190
Case
No.:272/13/82-
ALC4/2014
Party
Name:SAIBABA
SURFACTANTS
(P)
LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01275/AM15/
RLA
File
:08/24/040/00249/AM15/
Lic.No/Date:0810133587
14.10.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for comments of Department of Pharmaceuticals.
191
Case
No.:113/9/82-
ALC4/2014
Party
Name:ASTRIX
LABORATORIES LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00910/AM15/
RLA
File
:09/24/040/00370/AM15/
Lic.No/Date:0910061093
15.10.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Lamivudine based on the recommendation of, D/o Pharmaceuticals provided vide O.M.No.35011/219/2015-PI (Norms) dated11.09.2015, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.
192
Case
No.:114/9/82-
ALC4/2014
Party
Name:HONOUR
LAB LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00911/AM15/
RLA
File
:09/24/040/00386/AM15/
Lic.No/Date:0910061094
15.10.2014
Defer
Date:28.10.2015
Decision :Information called for from the firm is awaited. The Committee accordingly decided to
defer the case.
193
Case
No.:115/9/82-
ALC4/2014
Party Name:NAGARJUNA
AGRICHEM LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00912/AM15/
RLA
File
:09/24/040/00376/AM15/
Lic.No/Date:0910061106
16.10.2014
Defer Date:
recommendation of D/o C&PC, provided vide U.O.No.15022/4/2011-Ch-II dated 10.07.2015 ,
HBP
Vol.1.
194
Case
No.:42/15/82-
ALC4/2014
Party Name:PVS AGRO
VET
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01329/AM15/
RLA
File
:09/24/040/00246/AM15/
Lic.No/Date:0910061105
16.10.2014
Defer
Date:28.10.2015
Decision :: It was decided to defer the case for 20.05.2015 for comments of Department of
Pharmaceuticals.
195
Case
No.:163/13/82-
ALC4/2014
Party
Name:S.M.
CHEMICALS
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01166/AM15/
RLA
File
:03/95/040/00450/AM15/
Lic.No/Date:0310790285
16.10.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product 2-Ethyl Hexyl Diphenyl
Phosphite based on the recommendation of D/o C&PC No.14010/64/2010 dated 8.10.2015 ,
HBP Vol.1. RA concerned may take necessary action as per decision of NC.
196
Case
No.:13/15/82-
ALC4/2014
Party
Name:VINS
BIOPRODUCTS LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01300/AM15/
RLA
File
:09/24/040/00290/AM15/
Lic.No/Date:0910061111
16.10.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for comments of DBT.
197 Case
No.:155/13/82-
ALC4/2014
Party
Name:AVA
CHEMICALS PVT.LTD.,
Meet
No/Date:9/82-
ALC4/2015
Status:Case
Approved
30.09.2015
HQ
File
:01/82/050/01158/AM15/
RLA
File
:03/94/040/00658/AM15/
Lic.No/Date:0310790361
17.10.2014
Defer Date:
Decision :It was decided to defer the case for want of comments of DBT.The Committee
decided to ratify norms for the export product EDTA Tetra Ammonium Liquid Assay Min 40%
based on the recommendation of D/o C&PC, provided vide U.O.No.14010/67/2011-Ch-II dated
20.9.2015 , uploaded along with these minutes or as applied by the firm whichever is less under
para
4.07
of
HBP
Vol.1.
198
Case
No.:136/13/82-
ALC4/2014
Party
Name:DHANUKA
LABORATORIES LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01139/AM15/
RLA
File
:05/23/040/00309/AM15/
Lic.No/Date:0510391614
17.10.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for comments of Department of Pharmaceuticals.
199
Case
No.:154/13/82-
ALC4/2014
Party
Name:GEM
AROMATICS PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01157/AM15/
RLA
File
:03/94/040/00680/AM15/
Lic.No/Date:0310790351
17.10.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for comments of of D/o C&PC (Chemical)
200
Case
No.:117/9/82-
ALC4/2014
Party
Name:INCHEM
LABORATORIES PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00914/AM15/
RLA
File
:09/24/040/00374/AM15/
Lic.No/Date:0910061119
17.10.2014
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/173/2015-PI (Norms)
dated 7.10.2015 , uploaded along with these minutes or as applied by the firm whichever is less
under
para
4.07
of
HBP
Vol.1.
201
Case
No.:124/13/82-
ALC4/2014
Party
Name:PANACEA
BIOTEC LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01127/AM15/
RLA
File
:05/24/040/00319/AM15/
Lic.No/Date:0510391623
17.10.2014
Defer
Date:28.10.2015
Decision :: It was decided to defer the case for comments of Department of DBT.
202
Case
No.:135/13/82-
ALC4/2014
Party
Name:SHREE
BANKEY
BEHARI
LAL
AROMATICS
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01138/AM15/
RLA
File
:05/24/040/00306/AM15/
Lic.No/Date:0510391639
17.10.2014
Defer Date:
recommendation of D/o C&PC, provided vide U.O.No.14010/28/2012-PI-Ch-II dated 30.9.2015 ,
HBP
Vol.1.
203
Case
No.:164/13/82-
ALC4/2014
Party
Name:SUN
PHARMACEUTICAL
INDUSTRIES LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01167/AM15/
RLA
File
:03/95/040/00593/AM15/
Lic.No/Date:0310790332
17.10.2014
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/62/2015-PI (Norms) dated
08.10.2015, uploaded along with these minutes or as applied by the firm whichever is less under
para
4.07
of
HBP
Vol.1.
204
Case
No.:165/13/82-
ALC4/2014
Party
Name:SUN
PHARMACEUTICAL
INDUSTRIES LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01168/AM15/
RLA
File
:03/95/040/00594/AM15/
Lic.No/Date:0310790350
17.10.2014
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/59/2015-PI (Norms) dated
08.10.2015, uploaded along with these minutes or as applied by the firm whichever is less under
para
4.07
of
HBP
Vol.1.
205
Case
No.:152/13/82-
ALC4/2014
Party
Name:INDOCO
REMEDIES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01155/AM15/
RLA
File
:03/94/040/00692/AM15/
Lic.No/Date:0310790392
20.10.2014
Defer
Date:28.10.2015
206
Case
No.:144/13/82-
ALC4/2014
Party
Name:PAYAL
PETROCHEM
PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01147/AM15/
RLA
File
:05/24/040/00293/AM15/
Lic.No/Date:0510391660
20.10.2014
Defer Date:
HBP
Vol.1.
207
Case
No.:145/13/82-
ALC4/2014
Party
Name:PAYAL
PETROCHEM
PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01148/AM15/
RLA
File
:05/24/040/00276/AM15/
Lic.No/Date:0510391659
20.10.2014
Defer Date:
HBP
Vol.1.
208
Case
No.:138/13/82-
ALC4/2014
Party
Name:RECKITT
BENCKISER
HEALTHCARE
INDIA
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01141/AM15/
RLA
File
:05/24/040/00330/AM15/
Lic.No/Date:0510391644
20.10.2014
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/55/2015-PI (Norms) dated
10.10.2015, uploaded along with these minutes or as applied by the firm whichever is less under
para
4.07
of
HBP
Vol.1.
209
Case
No.:139/13/82-
ALC4/2014
Party
Name:RECKITT
BENCKISER
HEALTHCARE
INDIA
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01142/AM15/
RLA
File
:05/24/040/00325/AM15/
Lic.No/Date:0510391645
20.10.2014
Defer
Date:28.10.2015
Decision : The committee noted that information called for from the firm is awaited. Accordingly
decided to defer the case.
210
Case
No.:169/13/82-
ALC4/2014
Party
Name:YASHO
INDUSTRIES PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01172/AM15/
RLA
File
:03/95/040/00602/AM15/
Lic.No/Date:0310790376
20.10.2014
Defer Date:
recommendation of D/o C&PC provided vide U.O.No.14010/95/2011-Ch-II dated 11.09.2015,
HBP
Vol.1.
211
Case
No.:129/13/82-
ALC4/2014
Party
Name:GULBRANDSEN
CHEMICALS PVT LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01132/AM15/
RLA
File
:34/24/040/00189/AM15/
Lic.No/Date:3410040631
21.10.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Diethyl Aluminium
chloride
(DEAC)
based
on
the
recommendation
of
D/o
C&PC
provided
vide
U.O.No.14010/49/2011-Ch-II dated 10.09.2015, uploaded along with these minutes or as applied
by
the
firm
whichever
is
less
under
para
4.07
of
HBP
Vol.1.
212
Case
No.:130/13/82-
ALC4/2014
Party
Name:ALEMBIC
PHARMACEUTICALS LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01133/AM15/
RLA
File
:34/24/040/00187/AM15/
Lic.No/Date:3410040633
22.10.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Valsartan and
Hydrochlorothiazide based on the recommendation of D/o Pharmaceuticals provided vide
O.M.No.35011/104/2015-PI (Norms) dated September, 2015, uploaded along with these minutes
or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.
213
Case
No.:78/10/82-
ALC4/2014
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00992/AM15/
RLA
File
:09/24/040/00393/AM15/
Lic.No/Date:0910061130
22.10.2014
Defer
Date:28.10.2015
Decision :The Committee decided to call for information as per recommendations of D/o
Pharmaceuticals provided vide O.M.No.35011/145/2015-PI (Norms) dated 5.10.2015 , uploaded
along with these minutes and deferred the case
214
Case
No.:80/10/82-
ALC4/2014
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00994/AM15/
RLA
File
:09/24/040/00394/AM15/
Lic.No/Date:0910061132
22.10.2014
Defer
Date:28.10.2015
Decision :it was decided to defer the case for want of comments of D/o Pharmaceuticals.
215
Case
No.:81/10/82-
ALC4/2014
Party
Name:HONOUR
LAB LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00995/AM15/
RLA
File
:09/24/040/00407/AM15/
Lic.No/Date:0910061133
22.10.2014
Defer
Date:28.10.2015
Decision :Information called for from the firm is awaited. The Committee accordingly decided to
defer the case.
216
Case
No.:171/13/82-
ALC4/2014
Party
Name:PRASOL
CHEMICALS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01174/AM15/
RLA
File
:03/95/040/00588/AM15/
Lic.No/Date:0310790482
22.10.2014
Defer
Date:30.09.2015
Decision :it was decided to defer the case for want of comments of of D/o C&PC (Chemical)
217
Case
No.:172/13/82-
ALC4/2014
Party
Name:PRASOL
CHEMICALS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01175/AM15/
RLA
File
:03/95/040/00362/AM15/
Lic.No/Date:0310790480
22.10.2014
Defer
Date:28.10.2015
Decision :it was decided to defer the case for want of comments of of D/o C&PC (Chemical)
218
Case
No.:170/13/82-
ALC4/2014
Party
Name:SAVLA
CHEMICALS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01173/AM15/
RLA
File
:03/95/040/00619/AM15/
Lic.No/Date:0310790490
22.10.2014
Defer
Date:28.10.2015
Decision :it was decided to defer the case for want of comments of of D/o C&PC
(Petrochemicals)
219
Case
No.:116/13/82-
ALC4/2014
Party
Name:SHANPAR
INDUSTRIES PVT. LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File RLA
File Lic.No/Date:3410040637 Defer Date:
:01/82/050/01119/AM15/
:34/24/040/00179/AM15/
22.10.2014
Decision :: it was decided to defer the case for want of comments of of D/o C&PC (Chemical)
220
Case
No.:110/13/82-
ALC4/2014
Party
Name:TATVA
CHINTAN
PHARMA
CHEM PVT LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01113/AM15/
RLA
File
:34/24/040/00188/AM15/
Lic.No/Date:3410040635
22.10.2014
Defer
Date:28.10.2015
Decision :it was decided to defer the case for want of comments of of D/o C&PC (Chemical)
221
Case
No.:36/18/82-
ALC4/2014
Party
Name:APEX
PHARMA,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01402/AM15/
RLA
File
:03/94/040/00551/AM15/
Lic.No/Date:0310790531
27.10.2014
Defer
Date:28.10.2015
Decision :The Committee decided to ratify norms for the export product Pimobendan BP based
on the recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/69/2015-PI
(N0rms) dated11.9.2015 , uploaded along with these minutes or as applied by the firm whichever
is
less
under
para
4.07
of
HBP
Vol.1.
222
Case
No.:84/10/82-
ALC4/2014
Party
Name:HETERO
DRUGS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00998/AM15/
RLA
File
:09/24/040/00400/AM15/
Lic.No/Date:0910061140
27.10.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Moxifloxacin
Hydrochloride based on the recommendation of D/o Pharmaceuticals provided vide
O.M.No.35011/190/2015-PI (Norms) dated 5.10.2015 , uploaded along with these minutes or as
applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA may take further action
accordingly.
223
Case
No.:83/10/82-
ALC4/2014
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00997/AM15/
RLA
File
:09/24/040/00402/AM15/
Lic.No/Date:0910061139
27.10.2014
Defer
Date:28.10.2015
Decision :: it was decided to defer the case for want of comments of D/o Pharmaceuticals.
224
Case
No.:87/13/82-
ALC4/2014
Party
Name:MALLADI
DRUGS
&
PHARMACEUTICALS
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01090/AM15/
RLA
File
:04/24/040/00196/AM15/
Lic.No/Date:0410159624
27.10.2014
Defer
Date:28.10.2015
Decision :Information called for from the firm is awaited. Accordingly decided to defer the case.
225
Case
No.:126/13/82-
ALC4/2014
Party
Name:KLJ
PLASTICIZERS LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File RLA
File Lic.No/Date:0510391765 Defer Date:
:01/82/050/01129/AM15/
:05/23/040/00311/AM15/
28.10.2014
Decision :The Committee decided to ratify norms for the export product Kanatol-400 based on
the recommendation of D/o C&PC provided vide U.O.No.14010/36/2011-Ch-II dated 10.09.2015,
HBP
Vol.1.
226
Case
No.:86/10/82-
ALC4/2014
Party
Name:SHIVA
PHARMACHEM LTD,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01000/AM15/
RLA
File
:34/24/040/00194/AM15/
Lic.No/Date:3410040644
30.10.2014
Defer
Date:28.10.2015
Decision :it was decided to defer the case for want of comments of of D/o C&PC (Chemical)
22
7
Case
No.:6/15/82-
ALC4/2014
Party
Name:SMILAX LABORATORIES LIMI
TED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Ca
se
Approved
HQ
File
:01/82/050/01293/AM
15/
RLA File :09/24/040/00378/AM15/
Lic.No/Date:0910061
161
30.10.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Clopidogrel
Camphorsulfonate based on the recommendation of D/o Pharmaceuticals provided vide
O.M.No.35011/189/20015-PI (Norms) dated 7.10.2015 , uploaded along with these minutes or as
applied
by
the
firm
whichever
is
less
under
para
4.07
of
HBP
Vol.1.
228
Case
No.:57/15/82-
ALC4/2014
Party
Name:VIVIMED
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01344/AM15/
RLA
File
:09/24/040/00410/AM15/
Lic.No/Date:0910061154
30.10.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product “Reversacol Humber
Blue” based on the recommendation of D/o C&PC provided vide U.O.14010/138/2011-Ch-II
dated 07.07.2015, uploaded along with these minutes or as applied by the firm whichever is less
under
para
4.07
of
HBP
Vol.1.
229
Case
No.:45/18/82-
ALC4/2014
Party Name:BAYER VAPI
PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01411/AM15/
RLA
File
:03/94/040/00697/AM15/
Lic.No/Date:0310790673
31.10.2014
Defer Date:
recommendation of D/o C&PC provided vide U.O.15022/1/2015-Ch-II dated 15.09.2015,
HBP
Vol.1.
230
Case
No.:104/13/82-
ALC4/2014
Party
Name:AMOL
PHARMACEUTICALS
PVT. LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File RLA
File Lic.No/Date:1310047687 Defer
:01/82/050/01107/AM15/ :13/24/040/00029/AM15/ 05.11.2014 Date:28.10.2015 Decision :: it was decided to send a copy of application to D/o C&PC. Accordingly, the case was deferred.
231
Case
No.:266/13/82-
ALC4/2014
Party
Name:ATUL
LIMITED,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01269/AM15/
RLA
File
:08/24/040/00289/AM15/
Lic.No/Date:0810133735
05.11.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments of D/o C&PC(Petrochemicals)
232
Case
No.:268/13/82-
ALC4/2014
Party
Name:ATUL
LIMITED,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01271/AM15/
RLA
File
:08/24/040/00283/AM15/
Lic.No/Date:0810133734
05.11.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments of D/o C&PC(Petrochemicals)
233
Case
No.:39/7/82-
ALC4/2015
Party
Name:MYLAN
LABORATORIES
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00644/AM16/
RLA
File
:09/24/040/00371/AM15/
Lic.No/Date:0910061181
05.11.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments of D/o Pharma
234
Case
No.:107/13/82-
ALC4/2014
Party
Name:SHIVA
PHARMACHEM LTD,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01110/AM15/
RLA
File
:34/24/040/00196/AM15/
Lic.No/Date:3410040655
05.11.2014
Defer
Date:28.10.2015
Decision ::It was decided to defer the case for want of comments of DC&PC(Chemicals).
235
Case
No.:121/13/82-
ALC4/2014
Party
Name:AKZO
NOBEL INDIA LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01124/AM15/
RLA
File
:02/24/040/00111/AM15/
Lic.No/Date:0210205126
07.11.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments of of D/o C&PC (Chemical)
236
Case
No.:31/15/82-
ALC4/2014
Party
Name:BELCO
PHARMA
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01318/AM15/
RLA
File
:05/23/040/00337/AM15/
Lic.No/Date:0510391872
07.11.2014
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/152/2015-PI (Norms)
dated 27.8.2015 , uploaded along with these minutes or as applied by the firm whichever is less
under
para
4.07
of
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Vol.1.
237
Case
No.:49/15/82-
ALC4/2014
Party Name:EYTAN LABS
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01336/AM15/
RLA
File
:09/24/040/00413/AM15/
Lic.No/Date:0910061189
07.11.2014
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.no.35011/192/2015-PI (Norms)
dated 11.09.2015 , uploaded along with these minutes or as applied by the firm whichever is less
under
para
4.07
of
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Vol.1.
238
Case
No.:23/15/82-
ALC4/2014
Party
Name:VENUS
REMEDIES LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01310/AM15/
RLA
File
:22/24/040/00065/AM15/
Lic.No/Date:2210015115
07.11.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments of D/o Pharmaceuticals.
239
Case
No.:2/13/82-
ALC4/2014
Party
Name:ATUL
LIMITED,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01005/AM15/
RLA
File
:08/24/040/00290/AM15/
Lic.No/Date:0810133762
10.11.2014
Defer Date:
Decision :It was decided to defer the case for want of comments of D/o C&PC(Petrochemicals)
240
Case
No.:3/13/82-
ALC4/2014
Party Name:AUROBINDO
PHARMA LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01006/AM15/
RLA
File
:09/24/040/00377/AM15/
Lic.No/Date:0910061197
10.11.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Mirtazapine based on
the recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/350/2012-PI (Norms)
dated Sept. 2012 , uploaded along with these minutes or as applied by the firm whichever is less
under
para
4.07
of
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Vol.1.
241
Case
No.:265/13/82-
ALC4/2014
Party
Name:H.J.AROCHEM
PVT. LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01268/AM15/
RLA
File
:08/24/040/00265/AM15/
Lic.No/Date:0810133768
10.11.2014
Defer
Date:28.10.2015
Decision :Information called for from the firm is awaited.
242
Case
No.:81/18/82-
ALC4/2014
Party
Name:R
L
FINE
CHEM
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01447/AM15/
RLA
File
:07/24/040/00270/AM15/
Lic.No/Date:0710106924
10.11.2014
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/203/2015-PI (Norms)
dated 16.09.2015 , uploaded along with these minutes or as applied by the firm whichever is less
under
para
4.07
of
HBP
Vol.1.
243
Case
No.:151/13/82-
ALC4/2014
Party
Name:REANNON
PHARMACEUTICALS
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01154/AM15/
RLA
File
:03/95/040/00631/AM15/
Lic.No/Date:0310790870
10.11.2014
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/109/2015-PI (Norms)
dated 11.09.2015 , uploaded along with these minutes or as applied by the firm whichever is less
under
para
4.07
of
HBP
Vol.1.
244
Case
No.:2/16/82-
ALC4/2014
Party
Name:VENUS
REMEDIES LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01354/AM15/
RLA
File
:22/24/040/00068/AM15/
Lic.No/Date:2210015116
10.11.2014
Defer Date:
Decision :: The Committee decided to ratify norms for the export product based on the
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/109/2015-PI (Norms)
dated 5.10.2015 , uploaded along with these minutes or as applied by the firm whichever is less
under
para
4.07
of
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Vol.1.
245
Case
No.:114/13/82-
ALC4/2014
Party
Name:VIRDEV
INTERMEDIATES
PVT
LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01117/AM15/
RLA
File
:52/24/040/00042/AM15/
Lic.No/Date:5210041292
10.11.2014
Defer
Date:28.10.2015
Decision :The committee decided to call for complete technical detail as per Appendix-33 and
deferred the case.
246
Case
No.:111/13/82-
ALC4/2014
Party
Name:ABEERS
PHARMACEUTICALS
PVT LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01114/AM15/
RLA
File
:05/23/040/00352/AM15/
Lic.No/Date:0510391927
11.11.2014
Defer
Date:28.10.2015
Decision :Information called for from the firm is awaited. The Committee accordingly decided to
defer the case.
247
Case
No.:4/13/82-
ALC4/2014
Party
Name:ASTRIX
LABORATORIES LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01007/AM15/
RLA
File
:09/24/040/00409/AM15/
Lic.No/Date:0910061211
11.11.2014
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/136/2015-PI (Norms)
dated 8.10.2015 , uploaded along with these minutes or as applied by the firm whichever is less
under
para
4.07
of
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248 Case No.:5/13/82- Party Name:ASTRIX Meet No/Date:9/82- Status:Case
ALC4/2014
LABORATORIES LTD.,
ALC4/2015
30.09.2015
Deferred
HQ
File
:01/82/050/01008/AM15/
RLA
File
:09/24/040/00325/AM15/
Lic.No/Date:0910061212
11.11.2014
Defer Date:
Decision :The Committee decided to defer the case for want of comments from DOP.
249
Case
No.:19/15/82-
ALC4/2014
Party
Name:MALLADI
DRUGS
&
PHARMACEUTICALS
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01306/AM15/
RLA
File
:04/24/040/00206/AM15/
Lic.No/Date:0410159706
11.11.2014
Defer
Date:28.10.2015
Decision :The Committee decided to call for the information based on the recommendation of
D/o Pharmaceuticals provided vide O.M.No.35011/214/2015-PI (Norms) dated 08.10.2015 ,
uploaded along with these minutes and deferred the case.
250
Case
No.:20/15/82-
ALC4/2014
Party
Name:MALLADI
DRUGS
&
PHARMACEUTICALS
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01307/AM15/
RLA
File
:04/24/040/00207/AM15/
Lic.No/Date:0410159705
11.11.2014
Defer
Date:28.10.2015
Decision :The Committee decided to call for the information based on the recommendation of
D/o Pharmaceuticals provided vide O.M.No.35011/214/2015-PI (Norms) dated 08.10.2015 ,
uploaded along with these minutes and deferred the case.
251
Case
No.:108/13/82-
ALC4/2014
Party
Name:SHREE
BANKEY
BEHARI
LAL
BOARD MILLS
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01111/AM15/
RLA
File
:05/24/040/00347/AM15/
Lic.No/Date:0510391926
11.11.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Menthol based on the
recommendation of D/o C&PC provided vide U.O.No.14010/28/2012-CH-II dated 30.09.2015 ,
HBP
Vol.1.
252
Case
No.:112/13/82-
ALC4/2014
Party
Name:SOLARIS
CHEMTECH
INDUSTRIES LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01115/AM15/
RLA
File
:34/24/040/00193/AM15/
Lic.No/Date:3410040672
11.11.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments of D/o Pharmaceuticals.
253
Case
No.:61/18/82-
ALC4/2014
Party
Name:TATVA
CHINTAN
PHARMA
CHEM PVT LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01427/AM15/
RLA
File
:34/24/040/00198/AM15/
Lic.No/Date:3410040676
11.11.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments of of D/o C&PC (Chemical)
254
Case
No.:100/4/82-
ALC4/2015
Party
Name:ESTEEM
INDUSTRIES PVT. LTD,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00139/AM16/
RLA
File
:17/24/040/00125/AM15/
Lic.No/Date:1710005978
12.11.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments of of D/o C&PC
(Petrochemicals)
255
Case
No.:7/13/82-
ALC4/2014
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01010/AM15/
RLA
File
:09/24/040/00446/AM15/
Lic.No/Date:0910061213
12.11.2014
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/190/2015-PI (Norms)
dated 5.10.2015 , uploaded along with these minutes or as applied by the firm whichever is less
under
para
4.07
of
HBP
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Case
No.:120/13/82-
ALC4/2014
Party
Name:JUBILANT
LIFE
SCIENCES
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01123/AM15/
RLA
File
:05/23/040/00325/AM15/
Lic.No/Date:0510391947
12.11.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments of of D/o C&PC (Chemical)
257
Case
No.:98/18/82-
ALC4/2014
Party
Name:KARNATAKA
ANTIBIOTICS
&
PHARMACEUTICALS
LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01464/AM15/
RLA
File
:07/24/040/00272/AM15/
Lic.No/Date:0710106948
12.11.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments of D/o Pharmaceuticals.
258
Case
No.:77/18/82-
ALC4/2014
Party
Name:LAKELAND
CHEMICALS
(INDIA)
LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01443/AM15/
RLA
File
:03/95/040/00629/AM14/
Lic.No/Date:0310790966
12.11.2014
Defer
Date:28.10.2015
Decision :: It was decided to defer the case for want of comments of of D/o C&PC (Chemical).
259
Case
No.:105/13/82-
ALC4/2014
Party
Name:PAYAL
PETROCHEM
PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01108/AM15/
RLA
File
:05/24/040/00336/AM15/
Lic.No/Date:0510391957
12.11.2014
Defer Date:
HBP
Vol.1.
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Case
No.:65/18/82-
ALC4/2014
Party
Name:DEEPAK
NITRITE LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01431/AM15/
RLA
File
:34/24/040/00199/AM15/
Lic.No/Date:3410040677
13.11.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments of of D/o C&PC (Chemical)
261
Case
No.:72/18/82-
ALC4/2014
Party
Name:J.B.
CHEMICALS
&
PHARMACEUTICALS
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01438/AM15/
RLA
File
:03/94/040/00773/AM15/
Lic.No/Date:0310791044
13.11.2014
Defer
Date:28.10.2015
Decision :The Committee decided to call for information based on the recommendation of D/o
Pharmaceuticals provided vide O.M.No.35011/153/2015 – PI(Norms) dated 26.8.2015, uploaded
along with these minutes and deferred the case.
262
Case
No.:42/18/82-
ALC4/2014
Party
Name:LAKELAND
CHEMICALS
(INDIA)
LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01408/AM15/
RLA
File
:03/95/040/00628/AM14/
Lic.No/Date:0310791049
13.11.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments of of D/o C&PC (Chemical)
263
Case
No.:14/15/82-
ALC4/2014
Party
Name:STERICON
PHARMA PVT.LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01301/AM15/
RLA
File
:07/24/040/00274/AM15/
Lic.No/Date:0710106972
13.11.2014
Defer Date:
recommendation of D/o Pharmaceuticals provided video.M.No.35011/146/2015 (Norms) dated
10.09.2015 , uploaded along with these minutes or as applied by the firm whichever is less under
para
4.07
of
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264
Case
No.:3/16/82-
ALC4/2014
Party
Name:VENUS
REMEDIES LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01355/AM15/
RLA
File
:22/24/040/00060/AM15/
Lic.No/Date:2210015126
13.11.2014
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.no.35011/125/2015-PI (Norms)
dated 5.10.2015 , uploaded along with these minutes or as applied by the firm whichever is less
under
para
4.07
of
HBP
Vol.1.
265
Case
No.:56/15/82-
ALC4/2014
Party
Name:VIVIMED
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01343/AM15/
RLA
File
:09/24/040/00431/AM15/
Lic.No/Date:0910061223
13.11.2014
Defer Date:
recommendation of D/o C&PC, provided vide No.14010/138/2011-Ch-II dated 7.7.2015, HBP Vol.1.
266
Case
No.:65/15/82-
ALC4/2014
Party
Name:ABEERS
PHARMACEUTICALS
PVT LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01352/AM15/
RLA
File
:05/23/040/00360/AM15/
Lic.No/Date:0510392011
14.11.2014
Defer
Date:28.10.2015
Decision : The committee noted that information called for from the firm is awaited. Accordingly
decided to defer the case.
267
Case
No.:1/16/82-
ALC4/2014
Party
Name:JAYANT
AGRO ORGANICS LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01353/AM15/
RLA
File
:03/94/040/00742/AM15/
Lic.No/Date:0310791095
14.11.2014
Defer Date:
recommendation of D/o C&PC, provided vide U.O.No.14010/2/2015-Ch-II dated 2.9.2015 ,
HBP
Vol.1.
268
Case
No.:119/13/82-
ALC4/2014
Party
Name:JUBILANT
GENERICS LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01122/AM15/
RLA
File
:05/23/040/00304/AM15/
Lic.No/Date:0510392008
14.11.2014
Defer
Date:28.10.2015
Decision :The Committee decided to call for information based on the recommendation of D/o
Pharmaceuticals provided vide O.M.No.35011/115/2015 PI(Norms) dated 5.10.2015, uploaded
along with these minutes and deferred the case.
269
Case
No.:59/15/82-
ALC4/2014
Party
Name:MALLADI
DRUGS
&
PHARMACEUTICALS
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01346/AM15/
RLA
File
:04/24/040/00216/AM15/
Lic.No/Date:0410159756
17.11.2014
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/202/2015-PI (Norms)
dated October 2015, uploaded along with these minutes or as applied by the firm whichever is
less
under
para
4.07
of
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Case
No.:41/15/82-
ALC4/2014
Party
Name:MYLAN
LABORATORIES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Rejected
HQ
File
:01/82/050/01328/AM15/
RLA
File
:09/24/040/00235/AM15/
Lic.No/Date:0910061256
17.11.2014
Defer Date:
Decision :The Committee decided reject the case based on the written comments provided by
D/o Pharmaceuticals vide letter No.35011/188/2015-PI (Norms) dated August, 2015, uploaded along with these minutes. RA may take further necessary action as per NC decision.
271
Case
No.:24/18/82-
ALC4/2014
Party
Name:SUSHANT
INDUSTRIES
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01390/AM15/
RLA
File
:03/95/040/00672/AM15/
Lic.No/Date:0310791170
18.11.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Ferrous Fumarate
BP/USP
based
on
the
recommendation
of
D/o
Pharmaceuticals
provided
vide
O.M.No.35011/220/2015-PI (Norms) dated 11.09.2015, uploaded along with these minutes or as
applied
by
the
firm
whichever
is
less
under
para
4.07
of
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Case
No.:50/15/82-
ALC4/2014
Party Name:SUVEN LIFE
SCIENCES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01337/AM15/
RLA
File
:09/24/040/00448/AM15/
Lic.No/Date:0910061263
18.11.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Thiabendazole based
on the recommendation of D/o Pharmaceuticals provided vide O.M.NO.35011/182/2015-PI
(Norms) dt.11.09.2015, uploaded along with these minutes or as applied by the firm whichever is
less
under
para
4.07
of
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Case
No.:9/13/82-
ALC4/2014
Party
Name:HETERO
DRUGS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01012/AM15/
RLA
File
:09/24/040/00453/AM15/
Lic.No/Date:0910061268
19.11.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Valacyclovir
Hydrochloride based on the recommendation of D/o Pharmaceuticals provided vide
O.M.NO.35011/193/2015-PI (Norms) dt.11.09.2015, uploaded along with these minutes or as
applied
by
the
firm
whichever
is
less
under
para
4.07
of
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Case
No.:11/13/82-
ALC4/2014
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01014/AM15/
RLA
File
:09/24/040/00460/AM15/
Lic.No/Date:0910061271
19.11.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Losartan Potassium
based on the recommendation of D/o Pharmaceuticals provided vide O.M.NO.35011/165/2015-
PI (Norms) dt.7.10.2015, uploaded along with these minutes or as applied by the firm whichever
is
less
under
para
4.07
of
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Case
No.:23/18/82-
ALC4/2014
Party
Name:LAKELAND
CHEMICALS
(INDIA)
LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01389/AM15/
RLA
File
:03/95/040/00697/AM14/
Lic.No/Date:0310791253
20.11.2014
Defer
Date:28.10.2015
Decision :The Committee decided to ratify norms for the export product Phenoxy Ethanol (SSL &AF) based on the recommendation of D/o C&PC provided vide U.O.No.14010/8/2011-Ch-II dated 7.10.2015, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.
276
Case
No.:5/16/82-
ALC4/2014
Party
Name:MEDREICH
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01357/AM15/
RLA
File
:07/24/040/00292/AM15/
Lic.No/Date:0710107026
20.11.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Amoxicillin and
Potassium Clavulanate Tablets based on the recommendation of D/o Pharmaceuticals provided
vide O.M.No.35011/168/2015-PI (Norms) dated 5.10.2015 , uploaded along with these minutes
or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.
277
Case
No.:110/18/82-
ALC4/2014
Party
Name:MEDREICH
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01476/AM15/
RLA
File
:07/24/040/00305/AM15/
Lic.No/Date:0710107025
20.11.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Amoxicillin and
Potassium Clavulanate Tablets 625 mg. based on the recommendation of D/o Pharmaceuticals
provided vide O.M.No.35011/154/2015-PI (Norms) dated 11.09.2015 , uploaded along with these
minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.
278
Case
No.:52/15/82-
ALC4/2014
Party
Name:MYLAN
LABORATORIES
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01339/AM15/
RLA
File
:09/24/040/00408/AM15/
Lic.No/Date:0910061280
20.11.2014
Defer
Date:28.10.2015
Decision :The Committee decided to call for technical information based on the recommendation
of D/o Pharmaceuticals provided vide O.M.No.35011/228/2015-PI (Norms) dated 8.10.2015 ,
uploaded along with these minutes and deferred the case
279
Case
No.:122/13/82-
ALC4/2014
Party
Name:PAYAL
PETROCHEM
PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01125/AM15/
RLA
File
:05/24/040/00353/AM15/
Lic.No/Date:0510392082
20.11.2014
Defer Date:
HBP
Vol.1.
280
Case
No.:123/13/82-
ALC4/2014
Party
Name:PAYAL
PETROCHEM
PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01126/AM15/
RLA
File
:05/24/040/00376/AM15/
Lic.No/Date:0510392087
20.11.2014
Defer Date:
HBP Vol.1.
281
Case
No.:5/15/82-
ALC4/2014
Party
Name:PVS
LABORATORIES LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01292/AM15/
RLA
File
:09/24/040/00333/AM15/
Lic.No/Date:0910061275
20.11.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Toltracure based on the
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/156/2015-PI (Norms)
dated 11.09.2015 , uploaded along with these minutes or as applied by the firm whichever is less
under
para
4.07
of
HBP
Vol.1.
282
Case
No.:34/18/82-
ALC4/2014
Party
Name:ENCUBE
ETHICALS PVT LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01400/AM15/
RLA
File
:03/94/040/00803/AM15/
Lic.No/Date:0310791303
21.11.2014
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments from DoP.
283
Case
No.:59/18/82-
ALC4/2014
Party
Name:HEMA
PHARMACEUTICALS PVT.
LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01425/AM15/
RLA
File
:34/24/040/00220/AM15/
Lic.No/Date:3410040708
21.11.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product 1,3 Propanediol
Acetate-98% Min. based on the recommendation of D/o Pharmaceuticals provided vide
O.M.No.35011/78/2015-PI (Norms) dated 11.09.2015 , uploaded along with these minutes or as
applied
by
the
firm
whichever
is
less
under
para
4.07
of
HBP
Vol.1.
284
Case
No.:16/18/82-
ALC4/2014
Party
Name:KAIRAV
CHEMOFARBE
INDUSTRIES LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01382/AM15/
RLA
File
:03/94/040/00789/AM15/
Lic.No/Date:0310791300
21.11.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments from of D/o C&PC (Chemical)
285
Case
No.:93/18/82-
ALC4/2014
Party
Name:GULBRANDSEN
CHEMICALS PVT LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01459/AM15/
RLA
File
:34/24/040/00225/AM15/
Lic.No/Date:3410040718
24.11.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Ethyl Aluminium Sesqui
Chloride
(EASC)
based
on
the
recommendation
of
D/o
C&PC
provided
vide
U.O.No.14010/49/2011-Ch-II dated 10.09.2015, uploaded along with these minutes or as applied
by
the
firm
whichever
is
less
under
para
4.07
of
HBP
Vol.1.
286
Case
No.:19/18/82-
ALC4/2014
Party
Name:INDOCO
REMEDIES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01385/AM15/
RLA
File
:03/94/040/00801/AM15/
Lic.No/Date:0310791351
24.11.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Chlordiazepoxide
Capsules BP based on the recommendation of D/o Pharmaceuticals provided vide
O.M.No.35011/118/2015-PI (Norms) dated 30.09.2015 , uploaded along with these minutes or as
applied
by
the
firm
whichever
is
less
under
para
4.07
of
HBP
Vol.1.
287
Case
No.:74/18/82-
ALC4/2014
Party Name:ADESHWAR
MEDITEX PVT. LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01440/AM15/
RLA
File
:03/94/040/00814/AM15/
Lic.No/Date:0310791373
25.11.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments from D/o C&PC.
288
Case
No.:18/18/82-
ALC4/2014
Party
Name:ANTHEA
AROMATICS PVT.LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01384/AM15/
RLA
File
:03/94/040/00792/AM15/
Lic.No/Date:0310791374
25.11.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comments from of D/o C&PC (Chemical)
289
Case
No.:32/18/82-
ALC4/2014
Party
Name:BDR
PHARMACEUTICALS
INTERNATIONAL
PVT.
LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01398/AM15/
RLA
File
:03/94/040/00784/AM15/
Lic.No/Date:0310791380
25.11.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Clarithromycin USP
based on the recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/98/2015-PI
(Norms) dated 11.09.2015 , uploaded along with these minutes or as applied by the firm
whichever
is
less
under
para
4.07
of
HBP
Vol.1.
290
Case
No.:53/18/82-
ALC4/2014
Party
Name:CATAPHARMA
CHEMICALS PVT. LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01419/AM15/
RLA
File
:31/83/040/00057/AM15/
Lic.No/Date:3110065095
25.11.2014
Defer
Date:28.10.2015
Decision : The Committee considered the case for ratification of norms as per agenda. The
representative of C&PC explained the reason why the department has allowed 5% wastage
whoever, since the export product and import item has same description and chemical
compound, the committee decided that while fixing wastage it is necessary to specify the purity
of export and import items in the comments of each case. DC&PC may accordingly furnish
revised recommendations. The committee accordingly decided to defer the case.
291 Case
No.:95/13/82-
ALC4/2014
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
Status:Case
Approved
30.09.2015
HQ
File
:01/82/050/01098/AM15/
RLA
File
:09/24/040/00465/AM15/
Lic.No/Date:0910061301
25.11.2014
Defer Date:
Decision :The Committee decided to ratify norms as per earlier decision taken by NC in its
meeting No.07/82 dated 24.07.2015, uploaded along with these minutes, or as applied by the
firm
whichever
is
less
under
Para
4.7
of
HBP.
RA may take appropriate action as per the decision of Norms Committee.
292
Case
No.:96/13/82-
ALC4/2014
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01099/AM15/
RLA
File
:09/24/040/00466/AM15/
Lic.No/Date:0910061302
25.11.2014
Defer Date:
Decision :The Committee decided to ratify norms as per earlier decision taken by NC in its
meeting No.18/82 dated 18.2.2015, uploaded along with these minutes, or as applied by the firm
whichever
is
less
under
Para
4.7
of
HBP.
RA may take appropriate action as per the decision of Norms Committee.
293
Case
No.:15/2/82-
ALC4/2015
Party
Name:SHALINA
LABORATORIES
PVT.
LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00030/AM16/
RLA
File
:03/95/040/00639/AM15/
Lic.No/Date:0310791416
25.11.2014
Defer
Date:28.10.2015
Decision :The Committee decided defer the case for want of comments of DC&PC
294
Case
No.:17/18/82-
ALC4/2014
Party Name:DANOPHARM
CHEMICALS
PRIVATE
LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01383/AM15/
RLA
File
:03/94/040/00691/AM15/
Lic.No/Date:0310791453
26.11.2014
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/80/2015-PI (Norms) dated
September 2015, uploaded along with these minutes or as applied by the firm whichever is less
under
para
4.07
of
HBP
Vol.1.
295
Case
No.:99/13/82-
ALC4/2014
Party
Name:HETERO
DRUGS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01102/AM15/
RLA
File
:09/24/040/00472/AM15/
Lic.No/Date:0910061318
26.11.2014
Defer
Date:28.10.2015
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/248/2015-PI (Norms)
dated 8.10.2015 , uploaded along with these minutes or as applied by the firm whichever is less
under
para
4.07
of
HBP
Vol.1.
296
Case
No.:4/16/82-
ALC4/2014
Party Name:MICRO LABS
LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01356/AM15/
RLA
File
:07/24/040/00303/AM15/
Lic.No/Date:0710107083
26.11.2014
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/52/2015-PI (Norms) dated
September 2015, uploaded along with these minutes or as applied by the firm whichever is less
under
para
4.07
of
HBP
Vol.1.
297
Case No.:66/18/82-ALC4/2014 Party Name:BENZO CHEM
INDUSTRIES
PRIVATE
LIMITED,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01432/AM15/
RLA
File
:03/94/040/00739/AM15/
Lic.No/Date:0310791375
25.11.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product based on the recommendation of
D/o C&PC, provided vide U.O.No.14010/29/2011-Ch-II dated 11.09.2015 , uploaded along with these
minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.
298
Case
No.:15/15/82-
ALC4/2014
Party
Name:RANBAXY
LABORATORIES LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01302/AM15/
RLA
File
:05/24/040/00385/AM15/
Lic.No/Date:0510392153
26.11.2014
Defer Date:
Decision :The Committee decide to ratiry the norms as per SION for this product. RA concerned
may take further action as per decision of NC.
299
Case
No.:43/18/82-
ALC4/2014
Party
Name:YASHO
INDUSTRIES PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01409/AM15/
RLA
File
:03/95/040/00701/AM15/
Lic.No/Date:0310791419
26.11.2014
Defer
Date:28.10.2015
Decision :The Committee decided defer the case for want of comments of DC&PC
300
Case
No.:103/18/82-
ALC4/2014
Party
Name:ALEMBIC
PHARMACEUTICALS
LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01469/AM15/
RLA
File
:34/24/040/00197/AM15/
Lic.No/Date:3410040726
27.11.2014
Defer
Date:28.10.2015
Decision :
301
Case
No.:10/2/82-
ALC4/2015
Party
Name:JUBILANT
GENERICS LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00025/AM16/
RLA
File
:05/23/040/00211/AM15/
Lic.No/Date:0510392167
27.11.2014
Defer
Date:28.10.2015
Decision :The Committee decided defer the case for want of comments of DoP
302
Case
No.:100/13/82-
ALC4/2014
Party Name:HETERO LABS
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01103/AM15/
RLA
File
:09/24/040/00473/AM15/
Lic.No/Date:0910061319
26.11.2014
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/247/2015-PI (Norms)
dated 5.10.2015 , uploaded along with these minutes or as applied by the firm whichever is less
under
para
4.07
of
HBP
Vol.1.
303
Case
No.:11/2/82-
ALC4/2015
Party
Name:JUBILANT
GENERICS LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00026/AM16/
RLA
File
:05/23/040/00370/AM15/
Lic.No/Date:0510392171
27.11.2014
Defer
Date:28.10.2015
Decision :The Committee decided defer the case for want of comments of DoP
304
Case
No.:16/15/82-
ALC4/2014
Party
Name:RANBAXY
LABORATORIES LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01303/AM15/
RLA
File
:05/24/040/00386/AM15/
Lic.No/Date:0510392199
27.11.2014
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/158/2015-PI (Norms) date
11.09. 2015 , uploaded along with these minutes or as applied by the firm whichever is less
under
para
4.07
of
HBP
Vol.1.
305
Case
No.:11/15/82-
ALC4/2014
Party
Name:SWATI
MENTHOL
&
ALLIED
CHEMICALS LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01298/AM15/
RLA
File
:29/24/040/00008/AM15/
Lic.No/Date:2910025174
27.11.2014
Defer Date:
recommendation of D/o C&PC, provided vide U.O.No.14010/8/2015-Ch-II dated 30.09.2015,
HBP Vol.1. RA may take further action accordingly.
306
Case
No.:64/18/82-
ALC4/2014
Party
Name:DEEPAK
NITRITE LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01430/AM15/
RLA
File
:34/24/040/00227/AM15/
Lic.No/Date:3410040733
28.11.2014
Defer Date:
recommendation of D/o C&PC, provided vide U.O.No.14010/36/2012-Ch-II dated 4.09.2015 ,
307
Case
No.:114/18/82-
ALC4/2014
Party
Name:IND-SWIFT
LABORATORIES LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01480/AM15/
RLA
File
:22/24/040/00073/AM15/
Lic.No/Date:2210015135
28.11.2014
Defer
Date:28.10.2015
Decision :The Committee, based on the written comments received from DoP vide their O.M. no. 35011/162/2015-PI (Norms) dated 08.10.2015, decided to call for complete set of application frim the firm.
308
Case
No.:26/18/82-
ALC4/2014
Party
Name:SADHANA
NITRO CHEM LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01392/AM15/
RLA
File
:03/95/040/00714/AM15/
Lic.No/Date:0310791516
28.11.2014
Defer
Date:28.10.2015
Decision :The Committee decided defer the case for want of comments of of D/o C&PC
(Chemical)
309
Case
No.:92/18/82-
ALC4/2014
Party
Name:TATVA
CHINTAN
PHARMA
CHEM PVT LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01458/AM15/
RLA
File
:34/24/040/00224/AM15/
Lic.No/Date:3410040732
28.11.2014
Defer
Date:28.10.2015
Decision :The Committee decided defer the case for want of comments of of D/o C&PC
(Chemical)
310
Case
No.:89/18/82-
ALC4/2014
Party
Name:BALAJI
AMINES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01455/AM15/
RLA
File
:31/83/040/00191/AM15/
Lic.No/Date:3110065116
02.12.2014
Defer Date:
recommendation of D/o C&PC provided vide U.O.No.14010/122/2011-Ch-II dated 5.10.2015,
311
Case
No.:90/18/82-
ALC4/2014
Party
Name:BALAJI
AMINES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01456/AM15/
RLA
File
:31/83/040/00190/AM15/
Lic.No/Date:3110065117
02.12.2014
Defer Date:
recommendation of D/o C&PC provided vide U.O.No.14010/122/2011-Ch-II dated 05.10.2015,
312
Case
No.:67/18/82-
ALC4/2014
Party
Name:BENZO
CHEM
INDUSTRIES
PRIVATE LIMITED,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01433/AM15/
RLA
File
:03/94/040/00328/AM15/
Lic.No/Date:0310791619
02.12.2014
Defer
Date:28.10.2015
Decision :The Committee decided defer the case for want of comments of D/o C&PC (Chemical)
313
Case
No.:60/18/82-
ALC4/2014
Party
Name:DHANUKA
LABORATORIES LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File RLA
File Lic.No/Date:0510392257 Defer Date:
:01/82/050/01426/AM15/
:05/23/040/00397/AM15/
02.12.2014
recommendation of D/o Pharmaceuticals provided vide O.M.no.35011/79/2015-PI (Norms) dated
11.09.2015, uploaded along with these minutes or as applied by the firm whichever is less under
314
Case
No.:36/7/82-
ALC4/2015
Party
Name:HEPTACHEM
&
PHARMA (INDIA) PVT
LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00641/AM16/
RLA
File
:09/24/040/00406/AM15/
Lic.No/Date:0910061331
02.12.2014
Defer
Date:28.10.2015
Decision :The Committee decided defer the case for want of comments of of D/o C&PC
(Chemical)
315
Case
No.:102/13/82-
ALC4/2014
Party Name:DR REDDYS
LABORATORIES
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01105/AM15/
RLA
File
:09/24/040/00487/AM15/
Lic.No/Date:0910061336
04.12.2014
Defer
Date:28.10.2015
recommendation of D/o Pharmaceuticals provided vide O.M.no.35011/235/2015-PI (Norms)
dated 07.10.2015, uploaded along with these minutes or as applied by the firm whichever is less
316
Case
No.:87/18/82-
ALC4/2014
Party
Name:STERLING
AUXILIARIES PVT LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01453/AM15/
RLA
File
:03/95/040/00755/AM15/
Lic.No/Date:0310791744
05.12.2014
Defer
Date:28.10.2015
Decision :The Committee decided defer the case for want of comments of of D/o C&PC
(Chemical)
317
Case
No.:62/18/82-
ALC4/2014
Party
Name:MOREPEN
LABORATORIES LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01428/AM15/
RLA
File
:05/24/040/00409/AM15/
Lic.No/Date:0510392319
08.12.2014
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/141/2015-PI (Norms)
dated October 2015, uploaded along with these minutes or as applied by the firm whichever is
less
under
para
4.07
of
HBP
Vol.1.
318
Case
No.:32/15/82-
ALC4/2014
Party
Name:AMINES
&
PLASTICIZERS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01319/AM15/
RLA
File
:03/94/040/00848/AM15/
Lic.No/Date:0310791849
09.12.2014
Defer Date:
recommendation of D/o C&PC provided vide U.O.No.14010/61/2013-Ch-II dated 5.10.2015,
319
Case
No.:282/13/82-
ALC4/2014
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01285/AM15/
RLA
File
:09/24/040/00505/AM15/
Lic.No/Date:0910061366
09.12.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Darunavir Amorphous
based on the recommendation of D/o Pharmaceuticals provided vide O.M.no.35011/246/2015-PI
(Norms) dated 29.09.2015, uploaded along with these minutes or as applied by the firm
whichever is less under para 4.07 of HBP Vol.1. RA may take further action accordingly
320
Case
No.:283/13/82-
ALC4/2014
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01286/AM15/
RLA
File
:09/24/040/00501/AM15/
Lic.No/Date:0910061367
09.12.2014
Defer Date:
Decision :The Committee decided to ratify norms for the export product Valsartan based on the
recommendation of D/o Pharmaceuticals provided vide O.M.no.35011/246/2015-PI (Norms)
dated 29.09.2015, uploaded along with these minutes or as applied by the firm whichever is less
321
Case
No.:82/18/82-
ALC4/2014
Party
Name:ABEERS
PHARMACEUTICALS
PVT LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01448/AM15/
RLA
File
:05/23/040/00413/AM15/
Lic.No/Date:0510392368
10.12.2014
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments from AYUSH.
322
Case
No.:101/4/82-
ALC4/2015
Party
Name:ESTEEM
INDUSTRIES PVT. LTD,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00140/AM16/
RLA
File
:17/24/040/00144/AM15/
Lic.No/Date:1710005998
10.12.2014
Defer
Date:28.10.2015
Decision :The committee decided defer the case for want of comments from DC&PC
(Petrochemical).
323
Case
No.:120/18/82-
ALC4/2014
Party
Name:G.G.CHEMICALS &
PHARMACEUTICALS
PVT.LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01486/AM15/
RLA
File
:22/24/040/00077/AM15/
Lic.No/Date:2210015143
10.12.2014
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.no.35011/226/2015-PI (Norms)
dated 29.09.2015, uploaded along with these minutes or as applied by the firm whichever is less
324
Case
No.:57/18/82-
ALC4/2014
Party
Name:PAYAL
PETROCHEM
PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01423/AM15/
RLA
File
:05/24/040/00400/AM15/
Lic.No/Date:0510392365
10.12.2014
Defer Date:
HBP
Vol.1.
325
Case
No.:97/18/82-
ALC4/2014
Party
Name:DYNAMIC
SPECIALITY
CHEMICALS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01463/AM15/
RLA
File
:30/24/040/00041/AM15/
Lic.No/Date:3010103261
11.12.2014
Defer
Date:28.10.2015
Decision
:The Committee decide to
defer the case for want of comments of
DC&PC(Petrochemicals).
326
Case
No.:284/13/82-
ALC4/2014
Party Name:HONOUR LAB
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01287/AM15/
RLA
File
:09/24/040/00509/AM15/
Lic.No/Date:0910061372
12.12.2014
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.no.35011/245/2015-PI (Norms)
dated 29.09.2015, uploaded along with these minutes or as applied by the firm whichever is less
327
Case
No.:119/18/82-
ALC4/2014
Party
Name:V.D.H.
ORGANICS PVT. LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01485/AM15/
RLA
File
:05/24/040/00419/AM15/
Lic.No/Date:0510392414
15.12.2014
Defer
Date:28.10.2015
Decision :It was decided to defer the case for want of comment from of D/o C&PC (Chemical)
328
Case
No.:102/18/82-
ALC4/2014
Party
Name:ALEMBIC
PHARMACEUTICALS LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01468/AM15/
RLA
File
:34/24/040/00247/AM15/
Lic.No/Date:3410040787
16.12.2014
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.no.35011/73/2015-PI (Norms) dated
29.09.2015, uploaded along with these minutes or as applied by the firm whichever is less under
329
Case
No.:116/18/82-
ALC4/2014
Party
Name:CADILA
HEALTHCARE LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01482/AM15/
RLA
File
:08/24/040/00337/AM15/
Lic.No/Date:0810134056
16.12.2014
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.no.35011/76/2015-PI (Norms) dated
11.09.2015, uploaded along with these minutes or as applied by the firm whichever is less under
330
Case
No.:118/18/82-
ALC4/2014
Party
Name:H.J.AROCHEM
PVT. LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01484/AM15/
RLA
File
:08/24/040/00341/AM15/
Lic.No/Date:0810134067
16.12.2014
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments of of D/o C&PC
(Chemical)
331
Case
No.:106/18/82-
ALC4/2014
Party
Name:PANACEA
BIOTEC LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01472/AM15/
RLA
File
:05/24/040/00424/AM15/
Lic.No/Date:0510392443
16.12.2014
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments of DBT.
332
Case
No.:91/18/82-
ALC4/2014
Party
Name:ALCHEM
INTERNATIONAL LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01457/AM15/
RLA
File
:05/23/040/00449/AM15/
Lic.No/Date:0510392602
29.12.2014
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments of DC&PC.
333
Case
No.:84/18/82-
ALC4/2014
Party
Name:HESTER
BIOSCIENCES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01450/AM15/
RLA
File
:08/24/040/00362/AM15/
Lic.No/Date:0810134170
30.12.2014
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments of DBT.
334
Case
No.:3/1/82-
ALC4/2015
Party Name:JAGSONPAL
PHARMACEUTICALS
LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00003/AM16/
RLA
File
:05/23/040/00450/AM15/
Lic.No/Date:0510392649
01.01.2015
Defer
Date:28.10.2015
335
Case
No.:28/7/82-
ALC4/2015
Party
Name:PARAMOUNT
AROMACHEM PVT.LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00633/AM16/
RLA
File
:05/24/040/00428/AM15/
Lic.No/Date:0510392678
05.01.2015
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments of of D/o C&PC
(Chemical)
336
Case
No.:29/15/82-
ALC4/2014
Party
Name:HONOUR
LAB LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01316/AM15/
RLA
File
:09/24/040/00543/AM15/
Lic.No/Date:0910061501
07.01.2015
Defer
Date:28.10.2015
Decision :The committee noted that information called for from the firm is awaited. Accordingly decided to defer the case.
337
Case
No.:96/18/82-
ALC4/2014
Party
Name:NUTRA
SPECIALITIES
PVT.
LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01462/AM15/
RLA
File
:04/24/040/00248/AM15/
Lic.No/Date:0410159986
07.01.2015
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments of of D/o C&PC
(Chemical)
338
Case
No.:2/2/82-
ALC4/2015
Party Name:VIRUPAKSHA
ORGANICS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00017/AM16/
RLA
File
:09/24/040/00565/AM15/
Lic.No/Date:0910061498
07.01.2015
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.no.35011/271/2015-PI (Norms)
dated 01.09.2015, uploaded along with these minutes or as applied by the firm whichever is less
339
Case
No.:3/2/82-
ALC4/2015
Party Name:VIRUPAKSHA
ORGANICS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00018/AM16/
RLA
File
:09/24/040/00570/AM15/
Lic.No/Date:0910061502
07.01.2015
Defer Date:
Decision :The Committee decided to ratify norms for the export product Sofosbuvir based on the
recommendation of D/o Pharmaceuticals provided vide O.M.no.35011/179/2015-PI (Norms)
dated 01.09.2015, uploaded along with these minutes or as applied by the firm whichever is less
340
Case
No.:33/15/82-
ALC4/2014
Party
Name:HETERO
DRUGS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01320/AM15/
RLA
File
:09/24/040/00568/AM15/
Lic.No/Date:0910061507
08.01.2015
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.no.35011/250/2015-PI (Norms)
dated 5.10.2015, uploaded along with these minutes or as applied by the firm whichever is less
341
Case
No.:92/7/82-
ALC4/2015
Party
Name:RIDDHI
PHARMA
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00697/AM16/
RLA
File
:34/24/040/00266/AM15/
Lic.No/Date:3410040864
12.01.2015
Defer
Date:28.10.2015
Decision :The import item no.1 and export product are exactly the same. Firm may clarify their
request.
342
Case
No.:24/7/82-
ALC4/2015
Party Name:YASHASHVI
RASAYAN PVT.LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00629/AM16/
RLA
File
:52/24/040/00056/AM15/
Lic.No/Date:5210041389
12.01.2015
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments from of D/o C&PC
(Chemical)
343
Case
No.:6/16/82-
ALC4/2014
Party
Name:RELIANCE
INDUSTRIES LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01358/AM15/
RLA
File
:03/95/040/00351/AM15/
Lic.No/Date:0310792858
13.01.2015
Defer Date:
recommendation of D/o C&PC provided vide U.O.No.46011/113/2009-PC-II dated 23.7.2015 ,
344
Case
No.:7/16/82-
ALC4/2014
Party
Name:RELIANCE
INDUSTRIES LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01359/AM15/
RLA
File
:03/95/040/00141/AM15/
Lic.No/Date:0310792860
13.01.2015
Defer Date:
recommendation of D/o C&PC provided vide U.O.No.46011/113/2009-PC-II dated 23.7.2015 ,
345
Case
No.:8/16/82-
ALC4/2014
Party
Name:RELIANCE
INDUSTRIES LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01360/AM15/
RLA
File
:03/95/040/00243/AM15/
Lic.No/Date:0310792863
13.01.2015
Defer Date:
recommendation of D/o C&PC provided vide U.O.No.46011/113/2009-PC-II dated 23.7.2015 ,
346
Case
No.:11/16/82-
ALC4/2014
Party
Name:DR
REDDYS
LABORATORIES
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01363/AM15/
RLA
File
:09/24/040/00580/AM15/
Lic.No/Date:0910061549
21.01.2015
Defer
Date:28.10.2015
Decision :The Committee decided to send the copy of application to DoP.
347
Case
No.:10/16/82-
ALC4/2014
Party
Name:JODAS
EXPOIM PVT.LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01362/AM15/
RLA
File
:09/24/040/00529/AM15/
Lic.No/Date:0910061548
21.01.2015
Defer
Date:28.10.2015
Decision :The Committee based on the recommendation of D/o Pharmaceuticals provided vide
O.M.No.35011/309/2015-PI (Norms) dated 08.10.2015, uploaded along with these minutes
decided to call for DML from the firm and deferred the case.
348
Case
No.:12/16/82-
ALC4/2014
Party Name:RA CHEM
PHARMA LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01364/AM15/
RLA
File
:09/24/040/00592/AM15/
Lic.No/Date:0910061552
21.01.2015
Defer
Date:28.10.2015
Decision :The Committee decided to send the application to DoP.
349
Case
No.:14/16/82-
ALC4/2014
Party Name:HERBOCHEM Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01366/AM15/
RLA
File
:09/24/040/00572/AM15/
Lic.No/Date:0910061554
22.01.2015
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.No.35011/171/2015-PI (Norms)
dated 7.10.2015 , uploaded along with these minutes or as applied by the firm whichever is less
350
Case
No.:13/16/82-
ALC4/2014
Party
Name:HETERO
DRUGS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01365/AM15/
RLA
File
:09/24/040/00582/AM15/
Lic.No/Date:0910061553
22.01.2015
Defer Date:
recommendation of D/o Pharmaceuticals provided vide No.35011/248/2015-PI (Norms) dated
8.10.2015 , uploaded along with these minutes or as applied by the firm whichever is less under
351
Case
No.:14/1/82-
ALC4/2015
Party
Name:ANUH
PHARMA LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00014/AM16/
RLA
File
:03/94/040/00985/AM15/
Lic.No/Date:0310793308
27.01.2015
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments from DoP.
352
Case
No.:107/7/82-
ALC4/2015
Party
Name:CAMPHOR
& ALLIED PRODUCTS
LIMITED,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00712/AM16/
RLA
File
:03/94/040/00992/AM15/
Lic.No/Date:0310793305
27.01.2015
Defer
Date:28.10.2015
Decision :Information called for from the firm is awaited.
353
Case
No.:31/7/82-
ALC4/2015
Party
Name:V.D.H.
ORGANICS PVT. LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00636/AM16/
RLA
File
:05/24/040/00498/AM15/
Lic.No/Date:0510392987
27.01.2015
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments from of D/o C&PC
(Chemical)
354 Case
No.:32/7/82-
ALC4/2015
Party
Name:V.D.H.
ORGANICS PVT. LTD
Meet
No/Date:9/82-
ALC4/2015
Status:Case
Deferred
30.09.2015
HQ
File
:01/82/050/00637/AM16/
RLA
File
:05/24/040/00499/AM15/
Lic.No/Date:0510392988
27.01.2015
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments from of D/o C&PC
(Chemical)
355
Case
No.:25/7/82-
ALC4/2015
Party
Name:DEEPAK
NOVOCHEM
TECHNOLOGIES LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00630/AM16/
RLA
File
:31/83/040/00144/AM15/
Lic.No/Date:3110065235
28.01.2015
Defer
Date:28.10.2015
Decision :The Committee based on the recommendation of D/C&PC provided vide
U.O.No.14010/39/2011-Ch-IIdated 19.09.2015, uploaded along with these minutes decided to
call for information from the firm and deferred the case
356
Case
No.:7/1/82-
ALC4/2015
Party
Name:BDR
PHARMACEUTICALS
INTERNATIONAL
PVT.
LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00007/AM16/
RLA
File
:03/94/040/00971/AM15/
Lic.No/Date:0310793727
09.02.2015
Defer Date:
Decision : The Committee decided to ratify norms for the export product based on the
recommendation of D/o Pharmaceuticals provided vide No.35011/114/2015-PI (Norms) dated
01/09/2015 , uploaded along with these minutes or as applied by the firm whichever is less under
357
Case
No.:12/1/82-
ALC4/2015
Party
Name:INDOCO
REMEDIES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00012/AM16/
RLA
File
:03/94/040/01005/AM15/
Lic.No/Date:0310793729
09.02.2015
Defer
Date:28.10.2015
Decision : The Committee decided to ratify norms for the export product based on the
recommendation of D/o Pharmaceuticals provided vide No.35011/490/2014-PI (Norms) dated
09/02/2015 , uploaded along with these minutes or as applied by the firm whichever is less under
358
Case
No.:91/7/82-
ALC4/2015
Party
Name:SHREE
GANESH
REMEDIES
PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00696/AM16/
RLA
File
:34/24/040/00295/AM15/
Lic.No/Date:3410040965
16.02.2015
Defer
Date:28.10.2015
Decision :The Committee decided defer the case for want of comments of of D/o C&PC
(Chemical)
359
Case
No.:52/19/82-
ALC4/2014
Party Name:PCL OIL &
SOLVENTS LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01540/AM15/
RLA
File
:05/24/040/00273/AM15/
Lic.No/Date:0510393248
17.02.2015
Defer
Date:28.10.2015
Decision :The Committee decided defer the case for want of comments of DC&PC
(Petrochemical)
360
Case
No.:38/7/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00643/AM16/
RLA
File
:09/24/040/00640/AM15/
Lic.No/Date:0910061628
18.02.2015
Defer
Date:28.10.2015
Decision :The Committee decided defer the case for want of comments of DoP
361
Case
No.:11/1/82-
ALC4/2015
Party
Name:INDOCO
REMEDIES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00011/AM16/
RLA
File
:03/94/040/01070/AM15/
Lic.No/Date:0310793939
18.02.2015
Defer
Date:18.11.2015
Decision :The Committee decided to call for copy of Master Batch Formula from the firm and
deferred the case.
362
Case
No.:57/4/82-
ALC4/2015
Party
Name:SUNSHIELD
CHEMICALS LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00096/AM16/
RLA
File
:03/95/040/00982/AM15/
Lic.No/Date:0310793925
18.02.2015
Defer Date:
recommendation of D/o C&PC provided vide No.14010/107/2010-Ch-II dated 10.09.2015 ,
363
Case
No.:8/1/82-
ALC4/2015
Party
Name:BDR
PHARMACEUTICALS
INTERNATIONAL
PVT.
LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00008/AM16/
RLA
File
:03/94/040/00917/AM15/
Lic.No/Date:0310793987
19.02.2015
Defer
Date:18.11.2015
Decision :the Committee decided to defer the case for want of comments of DoP.
364
Case
No.:2/19/82-
ALC4/2014
Party
Name:SUN
PHARMACEUTICAL
INDUSTRIES LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01490/AM15/
RLA
File
:03/95/040/00916/AM15/
Lic.No/Date:0310793988
19.02.2015
Defer
Date:18.11.2015
365
Case
No.:4/19/82-
ALC4/2014
Party Name:AUROBINDO
PHARMA LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01492/AM15/
RLA
File
:09/24/040/00614/AM15/
Lic.No/Date:0910061647
24.02.2015
Defer Date:
recommendation of D/o Pharmaceuticals provided vide No.35011/196/2015-PI (Norms) dated
30.09.2015 , uploaded along with these minutes or as applied by the firm whichever is less under
366 Case No.:35/7/82- Party Name:MAHARSHI Meet No/Date:9/82- Status:Case
ALC4/2015
PHARMA
CHEM
PVT.LTD,
ALC4/2015
30.09.2015
Deferred
HQ
File
:01/82/050/00640/AM16/
RLA
File
:08/24/040/00425/AM15/
Lic.No/Date:0810134658
24.02.2015
Defer
Date:28.10.2015
Decision :The Committee decided defer the case for want of comments of DoP
367
Case
No.:46/19/82-
ALC4/2014
Party
Name:CADILA
HEALTHCARE LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01534/AM15/
RLA
File
:08/24/040/00442/AM15/
Lic.No/Date:0810134680
26.02.2015
Defer
Date:18.11.2015
Decision : The Committee decided to ratify norms as per earlier decision taken by NC in its
meeting No.15/82 dated 12.01.2015, uploaded along with these minutes or as applied by the firm
whichever is less: RA may take further necessary action as per decision of NC.
368
Case
No.:1/1/82-
ALC4/2015
Party
Name:PARAMOUNT
AROMACHEM PVT.LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00001/AM16/
RLA
File
:05/24/040/00563/AM15/
Lic.No/Date:0510393385
26.02.2015
Defer
Date:28.10.2015
Decision :The Committee decided defer the case for want of comments of of D/o C&PC
(Chemical)
369
Case
No.:47/19/82-
ALC4/2014
Party
Name:RUBY
FRAGRANCE PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01535/AM15/
RLA
File
:35/24/040/00006/AM15/
Lic.No/Date:3510044692
27.02.2015
Defer
Date:28.10.2015
Decision :The Committee decided defer the case for want of comments of of D/o C&PC
(Chemical)
370
Case
No.:48/19/82-
ALC4/2014
Party Name:AARTI DRUGS
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01536/AM15/
RLA
File
:03/94/040/01057/AM15/
Lic.No/Date:0310794361
04.03.2015
Defer Date:
Decision :The Committee based on the written comments of D/o Pharmaceuticals forwarded
vide O.M. No.35011/419/2015-PI(Norms) dated 13.10.2015 uploaded along with these minutes
decided ratify norms or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.
RA concerned may take necessary action as per decision of NC.
371
Case
No.:6/1/82-
ALC4/2015
Party
Name:MICRO
LABS LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00006/AM16/
RLA
File
:07/24/040/00446/AM15/
Lic.No/Date:0710107776
10.03.2015
Defer
Date:18.11.2015
372
Case
No.:15/1/82-
ALC4/2015
Party
Name:ALCHYMARS ICM
SM PRIVATE LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00015/AM16/
RLA
File
:04/24/040/00272/AM15/
Lic.No/Date:0410160273
11.03.2015
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments of DC&PC
373
Case
No.:50/19/82-
ALC4/2014
Party
Name:HETERO
DRUGS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01538/AM15/
RLA
File
:09/24/040/00679/AM15/
Lic.No/Date:0910061693
12.03.2015
Defer
Date:28.10.2015
Decision :The Committee decided based on the recommendation of D/o Pharmaceuticals
provided vide No.35011/236/2015-PI (Norms) dated 8.10.2015 , uploaded along with these
minutes decided to call for information from the firm.
374
Case
No.:51/19/82-
ALC4/2014
Party
Name:HONOUR
LAB LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01539/AM15/
RLA
File
:09/24/040/00693/AM15/
Lic.No/Date:0910061695
12.03.2015
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments of DC&PC.
375
Case
No.:53/19/82-
ALC4/2014
Party Name:ARENE LIFE
SCIENCES LIMITED.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01541/AM15/
RLA
File
:09/24/040/00558/AM14/
Lic.No/Date:0910061704
13.03.2015
Defer Date:
recommendation of D/o Pharmaceuticals provided vide No.35011/411/2015-PI (Norms) dated
29.09.2015 , uploaded along with these minutes or as applied by the firm whichever is less under
376
Case
No.:40/7/82-
ALC4/2015
Party
Name:GLOBAL
CALCIUM
PRIVATE
LIMITED,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00645/AM16/
RLA
File
:07/24/040/00351/AM15/
Lic.No/Date:0710107812
13.03.2015
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments of
DC&PC(Chemicals).
377
Case
No.:106/7/82-
ALC4/2015
Party
Name:ALCHEMIE
LABORATORIES
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00711/AM16/
RLA
File
:03/94/040/00812/AM15/
Lic.No/Date:0310794612
16.03.2015
Defer
Date:28.10.2015
Decision :The Cmmittee decided to defer the case for want of comments of DC&PC(Chemicals)
378
Case
No.:16/1/82-
ALC4/2015
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01542/AM15/
RLA
File
:09/24/040/00703/AM15/
Lic.No/Date:0910061716
17.03.2015
Defer
Date:28.10.2015
Decision :The Committee decided based on the recommendation of D/o Pharmaceuticals
provided vide No.35011/231/2015-PI (Norms) dated 01.09.2015 , uploaded along with these minutes decided to call for information from the firm.
379
Case
No.:103/7/82-
ALC4/2015
Party Name:VADIVARHE
SPECIALITY
CHEMICALS LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00708/AM16/
RLA
File
:03/95/040/01041/AM15/
Lic.No/Date:0310794641
17.03.2015
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments of DoP
380
Case
No.:20/1/82-
ALC4/2015
Party
Name:CADILA
HEALTHCARE LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01546/AM15/
RLA
File
:08/24/040/00474/AM15/
Lic.No/Date:0810134879
23.03.2015
Defer Date:
Decision :The Committee in light of the earlier decision taken by NC in its meeting No.10/82
dated 22.8.2013 (Uploaded along with these minutes) decided to ratify norms on repeat basis or
as applied by the firm whichever is less. RA concerned may take further necessary action as per
decision of NC.
381
Case
No.:23/1/82-
ALC4/2015
Party
Name:S
M
S
PHARMACEUTICALS LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01549/AM15/
RLA
File
:09/24/040/00579/AM15/
Lic.No/Date:0910061762
24.03.2015
Defer Date:
recommendation of D/o Pharmaceuticals provided vide No.35011/261/2015-PI (Norms) dated
5.10.2015 , uploaded along with these minutes or as applied by the firm whichever is less under
para 4.07 of HBP Vol.1. RA may take further action accordingly
382
Case
No.:28/1/82-
ALC4/2015
Party
Name:DHANUKA
LABORATORIES LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01554/AM15/
RLA
File
:05/23/040/00556/AM15/
Lic.No/Date:0510393745
26.03.2015
Defer
Date:18.11.2015
Decision : The Committee decided to ratify norms for the export product based on the
recommendation of D/o Pharmaceuticals provided vide No.35011/424/2015-PI (Norms) dated
October .2015 , uploaded along with these minutes or as applied by the firm whichever is less
under para 4.07 of HBP Vol.1. RA may take further action accordingly
383
Case
No.:29/1/82-
ALC4/2015
Party
Name:HONOUR
LAB LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/01555/AM15/
RLA
File
:09/24/040/00722/AM15/
Lic.No/Date:0910061789
30.03.2015
Defer
Date:28.10.2015
Decision :: Information called for from the firm is awaited. The Committee accordingly decided to
defer the case.
384
Case
No.:51/4/82-
ALC4/2015
Party
Name:PANACEA
BIOTEC LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00090/AM16/
RLA
File
:05/24/040/00607/AM15/
Lic.No/Date:0510393789
30.03.2015
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments of DBT.
385
Case
No.:9/1/82-
ALC4/2015
Party
Name:VIVIMED
LABS
(
ALATHUR)
PRIVATE LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00009/AM16/
RLA
File
:04/24/040/00292/AM15/
Lic.No/Date:0410160364
30.03.2015
Defer
Date:28.10.2015
386
Case
No.:104/7/82-
ALC4/2015
Party
Name:ANUH
PHARMA LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00709/AM16/
RLA
File
:03/94/040/01192/AM15/
Lic.No/Date:0310795054
31.03.2015
Defer
Date:28.10.2015
387
Case
No.:31/1/82-
ALC4/2015
Party Name:AUROBINDO
PHARMA LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/01557/AM15/
RLA
File
:09/24/040/00707/AM15/
Lic.No/Date:0910061820
31.03.2015
Defer Date:
recommendation of D/o Pharmaceuticals provided vide No.35011/196/2015-PI (Norms) dated
30.09.2015, uploaded along with these minutes or as applied by the firm whichever is less under
para 4.07 of HBP Vol.1. RA may take further action accordingly
388
Case
No.:179/7/82-
ALC4/2015
Party
Name:G.G.CHEMICALS &
PHARMACEUTICALS
PVT.LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00784/AM16/
RLA
File
:22/24/040/00118/AM15/
Lic.No/Date:2210015222
31.03.2015
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.no.35011/226/2015-PI (Norms)
dated 29.09.2015, uploaded along with these minutes or as applied by the firm whichever is less
389
Case
No.:131/7/82-
ALC4/2015
Party
Name:GUJARAT
ORGANICS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00736/AM16/
RLA
File
:03/94/040/00663/AM15/
Lic.No/Date:0310795309
15.04.2015
Defer Date:
recommendation of D/o C&PC provided vide U.O.no.14011/11/2013-Ch-II dated 30.09.2015,
390 Case
No.:12/7/82-
ALC4/2015
Party
Name:SHILPA
MEDICARE LTD.,
Meet
No/Date:9/82-
ALC4/2015
Status:Case
Approved
30.09.2015
HQ
File
:01/82/050/00617/AM16/
RLA
File
:07/24/040/00002/AM16/
Lic.No/Date:0710108028
15.04.2015
Defer Date:
391
Case
No.:154/7/82-
ALC4/2015
Party
Name:AVA
CHEMICALS PVT.LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00759/AM16/
RLA
File
:03/94/040/00022/AM16/
Lic.No/Date:0310795381
17.04.2015
Defer Date:
Decision :The Committee decided to ratify norms for the export product EDTA Tetra Ammonium
Liquid Assay Min 40% based on the recommendation of D/o C&PC, provided vide
U.O.No.14010/67/2011-Ch-II dated 20.9.2015 , uploaded along with these minutes or as applied
by
the
firm
whichever
is
less
under
para
4.07
of
HBP
Vol.1.
392
Case
No.:144/7/82-
ALC4/2015
Party
Name:ETERNIS
FINE
CHEMICALS
LIMITED,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00749/AM16/
RLA
File
:03/94/040/01200/AM15/
Lic.No/Date:0310795391
17.04.2015
Defer
Date:28.10.2015
DC&PC(Chemicals)
393
Case
No.:152/7/82-
ALC4/2015
Party
Name:ETERNIS
FINE
CHEMICALS
LIMITED,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00757/AM16/
RLA
File
:03/94/040/01210/AM15/
Lic.No/Date:0310795394
17.04.2015
Defer
Date:28.10.2015
Decision :The Committee based on the recommendation of D/o C&PC (Chemicals) provided
vide letter No.14010/57/2015-Ch-II dated 16.09.2015, uploaded along with these minutes
decided to call for information from the firm and deferred the case.
394
Case
No.:90/7/82-
ALC4/2015
Party
Name:PI
INDUSTRIES LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00695/AM16/
RLA
File
:13/24/040/00057/AM15/
Lic.No/Date:1310047841
17.04.2015
Defer Date:
recommendation of D/o C&PC provided vide U.O.No.15022/6/2010-Ch-II dated 30.09.2015,
395
Case
No.:132/7/82-
ALC4/2015
Party
Name:GLOBE
TROTTERS PVT LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00737/AM16/
RLA
File
:03/94/040/00024/AM16/
Lic.No/Date:0310795429
20.04.2015
Defer
Date:18.11.2015
396 Case No.:147/7/82- Party Name:INDOCO Meet No/Date:9/82- Status:Case
ALC4/2015
REMEDIES LIMITED
ALC4/2015
30.09.2015
Deferred
HQ
File
:01/82/050/00752/AM16/
RLA
File
:03/94/040/00036/AM16/
Lic.No/Date:0310795446
21.04.2015
Defer
Date:28.10.2015
Decision :The committee decided to call for copy of DML from the firm and deferred the case.
397
Case
No.:116/7/82-
ALC4/2015
Party
Name:YASHO
INDUSTRIES PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00721/AM16/
RLA
File
:03/95/040/00029/AM16/
Lic.No/Date:0310795476
22.04.2015
Defer Date:
recommendation of D/o C&PC provided vide U.O.No.14010/95/2011-Ch-II dated 30.4.2015,
398
Case
No.:153/7/82-
ALC4/2015
Party
Name:DR.
ACHARYA
LABORATORIES
PVT.
LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00758/AM16/
RLA
File
:03/94/040/00039/AM16/
Lic.No/Date:0310795534
24.04.2015
Defer
Date:18.11.2015
Decision :The Committee decided to defer the case for want of comments of DC&PC
399
Case
No.:29/7/82-
ALC4/2015
Party
Name:NUTRA
SPECIALITIES
PVT.
LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00634/AM16/
RLA
File
:04/24/040/00003/AM16/
Lic.No/Date:0410160438
24.04.2015
Defer
Date:28.10.2015
Decision : The Committee based on the recommendation of DoP provided vide O.M.
No.35011/268/2015-PI (norms)-II dated October 2015, uploaded along with these minutes
decided to call for information from the firm and deferred the case.
400
Case
No.:173/7/82-
ALC4/2015
Party
Name:UNIMAX
LABORATORIES
PVT.LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00778/AM16/
RLA
File
:03/95/040/00031/AM16/
Lic.No/Date:0310795525
24.04.2015
Defer
Date:28.10.2015
401
Case
No.:149/7/82-
ALC4/2015
Party
Name:AVA
CHEMICALS PVT.LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00754/AM16/
RLA
File
:03/94/040/00053/AM16/
Lic.No/Date:0310795564
27.04.2015
Defer Date:
Decision :The Committee decided to ratify norms for the export product Disodium Manganese
EDTA content 6% (+/- 0.5%) As mg. based on the recommendation of D/o C&PC, provided vide
U.O.No.14010/67/2011-Ch-II dated 2.9.2015 , uploaded along with these minutes or as applied
by
the
firm
whichever
is
less
under
para
4.07
of
HBP
Vol.1.
402
Case
No.:150/7/82-
ALC4/2015
Party
Name:AVA
CHEMICALS PVT.LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00755/AM16/
RLA
File
:03/94/040/00046/AM16/
Lic.No/Date:0310795563
27.04.2015
Defer Date:
Decision : The Committee decided to defer the case for want of comments of DCPC.
403
Case
No.:155/7/82-
ALC4/2015
Party
Name:INDOCO
REMEDIES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00760/AM16/
RLA
File
:03/94/040/00035/AM16/
Lic.No/Date:0310795581
28.04.2015
Defer
Date:28.10.2015
Decision :Decision :The Committee decided to call for Master Batch Formula from the firm.
404
Case
No.:174/7/82-
ALC4/2015
Party
Name:S
M
B
CORPORATION
OF
INDIA
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00779/AM16/
RLA
File
:03/95/040/00039/AM16/
Lic.No/Date:0310795601
28.04.2015
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments of PC Div. of DC&PC
405
Case
No.:156/7/82-
ALC4/2015
Party
Name:AVA
CHEMICALS PVT.LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00761/AM16/
RLA
File
:03/94/040/00007/AM16/
Lic.No/Date:0310795624
29.04.2015
Defer Date:
Decision :The Committee decided to ratify norms for the export product Disodium magnesium
content 6% (+/- 0.5%) As Mg. based on the recommendation of D/o C&PC, provided vide
U.O.No.14010/67/2011-Ch-II dated 20.9.2015 , uploaded along with these minutes or as applied
by
the
firm
whichever
is
less
under
para
4.07
of
HBP
Vol.1.
406
Case
No.:151/7/82-
ALC4/2015
Party
Name:J.B.
CHEMICALS
&
PHARMACEUTICALS
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00756/AM16/
RLA
File
:03/94/040/01216/AM15/
Lic.No/Date:0310795663
30.04.2015
Defer
Date:28.10.2015
Decision :The Committee decided to call for copy of DML from the firm.
407
Case
No.:82/7/82-
ALC4/2015
Party
Name:VARAHI
PHARMA
PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00687/AM16/
RLA
File
:09/24/040/00018/AM16/
Lic.No/Date:0910061954
01.05.2015
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.no.35011/280/2015-PI (Norms)
dated 5.10.2015, uploaded along with these minutes or as applied by the firm whichever is less
408 Case No.:81/7/82- Party Name:NEULAND Meet No/Date:9/82- Status:Case
ALC4/2015
LABORATORIES LTD
ALC4/2015
30.09.2015
Approved
HQ
File
:01/82/050/00686/AM16/
RLA
File
:09/24/040/00056/AM16/
Lic.No/Date:0910061972
05.05.2015
Defer Date:
recommendation of D/o Pharmaceuticals provided vide O.M.no.35011/215/2015-PI (Norms)
dated 30.09.2015, uploaded along with these minutes or as applied by the firm whichever is less
under para 4.07 of HBP Vol.1. RA may take further action accordingly
409
Case
No.:111/7/82-
ALC4/2015
Party
Name:ZIM
LABORATORIES LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00716/AM16/
RLA
File
:03/95/040/00058/AM16/
Lic.No/Date:0310795699
05.05.2015
Defer
Date:18.11.2015
410
Case
No.:50/7/82-
ALC4/2015
Party Name:ARENE LIFE
SCIENCES LIMITED.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00655/AM16/
RLA
File
:09/24/040/00041/AM16/
Lic.No/Date:0910061976
06.05.2015
Defer
Date:28.10.2015
411
Case
No.:4/7/82-
ALC4/2015
Party
Name:POSY
PHARMACHEM
PVT.
LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00609/AM16/
RLA
File
:08/24/040/00006/AM16/
Lic.No/Date:0810135194
06.05.2015
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments of DOP.
412
Case
No.:11/7/82-
ALC4/2015
Party
Name:CADILA
HEALTHCARE LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00616/AM16/
RLA
File
:08/24/040/00016/AM16/
Lic.No/Date:0810135204
07.05.2015
Defer
Date:28.10.2015
413
Case
No.:23/7/82-
ALC4/2015
Party
Name:CADILA
HEALTHCARE LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00628/AM16/
RLA
File
:08/24/040/00028/AM16/
Lic.No/Date:0810135220
07.05.2015
Defer
Date:28.10.2015
Decision : The Committee decided to defer the case for want of comments of DoP.
414
Case
No.:19/7/82-
ALC4/2015
Party Name:MAHARSHI
PHARMA
CHEM
PVT.LTD,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00624/AM16/
RLA
File
:08/24/040/00036/AM16/
Lic.No/Date:0810135218
07.05.2015
Defer
Date:18.11.2015
Decision : The Committee decided to defer the case for want of comments of DoP.
415
Case
No.:20/7/82-
ALC4/2015
Party
Name:MAHARSHI
PHARMA CHEM PVT.LTD,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00625/AM16/
RLA
File
:08/24/040/00035/AM16/
Lic.No/Date:0810135219
07.05.2015
Defer Date:
Decision : The Committee decided to ratify norms for the export product based on the
recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/241/2015-PI(Norms)
dated Sept. 2015 , uploaded along with these minutes or as applied by the firm whichever is less
under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.
416
Case
No.:3/3/82-
ALC4/2015
Party Name:RA CHEM
PHARMA LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00033/AM16/
RLA
File
:09/24/040/00077/AM16/
Lic.No/Date:0910061994
07.05.2015
Defer
Date:28.10.2015
417
Case
No.:108/7/82-
ALC4/2015
Party
Name:SHALINA
LABORATORIES
PVT.
LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00713/AM16/
RLA
File
:03/95/040/00003/AM16/
Lic.No/Date:0310795745
07.05.2015
Defer
Date:28.10.2015
418
Case
No.:191/7/82-
ALC4/2015
Party
Name:SURVIVAL
TECHNOLOGIES
PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00796/AM16/
RLA
File
:03/95/040/00065/AM16/
Lic.No/Date:0310795759
07.05.2015
Defer
Date:28.10.2015
DC&PC(Chemicals)
419
Case
No.:7/7/82-
ALC4/2015
Party
Name:SWISS
PARENTERALS
PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00612/AM16/
RLA
File
:08/24/040/00017/AM16/
Lic.No/Date:0810135225
08.05.2015
Defer
Date:28.10.2015
420
Case
No.:8/7/82-
ALC4/2015
Party
Name:SWISS
PARENTERALS
PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00613/AM16/
RLA
File
:08/24/040/00018/AM16/
Lic.No/Date:0810135226
08.05.2015
Defer
Date:28.10.2015
421
Case
No.:175/7/82-
ALC4/2015
Party
Name:YASHO
INDUSTRIES PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File RLA
File Lic.No/Date:0310795792 Defer Date:
:01/82/050/00780/AM16/
:03/95/040/00083/AM16/
08.05.2015
recommendation of D/o C&PC provided vide U.O.No.14010/95/2011-Ch-II dated 30.4.2015,
422
Case
No.:117/7/82-
ALC4/2015
Party
Name:ZIM
LABORATORIES LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00722/AM16/
RLA
File
:03/95/040/00079/AM16/
Lic.No/Date:0310795788
08.05.2015
Defer
Date:28.10.2015
423
Case
No.:30/7/82-
ALC4/2015
Party
Name:KLJ
PLASTICIZERS LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00635/AM16/
RLA
File
:05/23/040/00033/AM16/
Lic.No/Date:0510394185
11.05.2015
Defer Date:
Decision : The Committee decided to ratify norms for the export product “Kanatol-400(N)” based
on the recommendation of D/o C&PC provided vide U.O.No.140102/36/2011-Ch-II dated
10.09.2015, uploaded along with these minutes or as applied by the firm whichever is less under
para
4.07
of
HBP
Vol.1.
424
Case
No.:15/7/82-
ALC4/2015
Party
Name:MAHAVIR
SYNTHESIS
PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00620/AM16/
RLA
File
:52/24/040/00007/AM16/
Lic.No/Date:5210041517
11.05.2015
Defer
Date:28.10.2015
425
Case
No.:99/7/82-
ALC4/2015
Party
Name:ALEMBIC
PHARMACEUTICALS
LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00704/AM16/
RLA
File
:34/24/040/00040/AM16/
Lic.No/Date:3410041221
12.05.2015
Defer
Date:28.10.2015
426
Case
No.:139/7/82-
ALC4/2015
Party
Name:LUPIN
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00744/AM16/
RLA
File
:03/95/040/00068/AM16/
Lic.No/Date:0310795837
12.05.2015
Defer
Date:28.10.2015
Decision :The Committee decided to send a copy of application to DoP.
427
Case
No.:140/7/82-
ALC4/2015
Party
Name:LUPIN
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00745/AM16/
RLA
File
:03/95/040/00067/AM16/
Lic.No/Date:0310795839
12.05.2015
Defer
Date:28.10.2015
Decision : The Committee decided to send a copy of application to DoP.
428
Case
No.:141/7/82-
ALC4/2015
Party
Name:SANOFI
INDIA LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00746/AM16/
RLA
File
:03/95/040/00056/AM16/
Lic.No/Date:0310795833
12.05.2015
Defer
Date:18.11.2015
429
Case
No.:49/7/82-
ALC4/2015
Party
Name:BRUNDAVAN
LABORATORIES
PRIVATE LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00654/AM16/
RLA
File
:09/24/040/00059/AM16/
Lic.No/Date:0910062011
13.05.2015
Defer
Date:28.10.2015
430
Case
No.:146/7/82-
ALC4/2015
Party
Name:DORF-
KETAL
CHEMICALS
INDIA PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00751/AM16/
RLA
File
:03/94/040/00047/AM16/
Lic.No/Date:0310795883
13.05.2015
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments of DC&PC
431
Case
No.:130/7/82-
ALC4/2015
Party Name:POLYDRUG
LABORATORIES
PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00735/AM16/
RLA
File
:03/95/040/00045/AM16/
Lic.No/Date:0310795873
13.05.2015
Defer
Date:18.11.2015
Decision : The Committee decided to ratify norms for the export product based on the
recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/415/2015-PI(Norms)
dated October 2015 , uploaded along with these minutes or as applied by the firm whichever is
less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of
NC.
432
Case
No.:118/7/82-
ALC4/2015
Party
Name:RELIANCE
INDUSTRIES LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00723/AM16/
RLA
File
:03/95/040/00016/AM16/
Lic.No/Date:0310795868
13.05.2015
Defer Date:
Decision :The Committee decided to ratify norms for the export product Methyl Tertiary Butyl
Ether (MTBE) based on the recommendation of D/o C&PC provided vide letter No.
46011/36/2012-PC-II dated 01.10.2015, uploaded along with these minutes or as applied by the
firm whichever is less under para 4.07 of HBP Vol.1. RA may take further action accordingly.
433
Case
No.:119/7/82-
ALC4/2015
Party
Name:RELIANCE
INDUSTRIES LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00724/AM16/
RLA
File
:03/95/040/00017/AM16/
Lic.No/Date:0310795866
13.05.2015
Defer Date:
Decision : The Committee decided to ratify norms for the export product Methyl Tertiary Butyl
Ether
(MTBE)
based
on
the
recommendation
of
D/o
C&PC
provided
vide
O.M.No.46011/36/2012-PC-II dated 01.10.2015, uploaded along with these minutes or as
applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA may take further action accordingly.
434
Case
No.:21/7/82-
ALC4/2015
Party
Name:SUN
PHARMACEUTICAL
INDUSTRIES LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00626/AM16/
RLA
File
:05/24/040/00058/AM16/
Lic.No/Date:0510394210
13.05.2015
Defer Date:
Decision :The Committee in light of the comments of the representative of DoP decided to ratify
norms for the export product “Volini Gel 30 gm (each tube contains equivalent to 1.5gm of
Racementhol” as per details given below or as applied by the firm whichever is less under para
4.7
of
HBP:
Export product Qty. Import items Qty. Volini Gel 30 gm (each tube contains equivalent to 1.5gm of Racementhol” 1 number of tube Racementhol 1.5gm/ per tube
435
Case
No.:120/7/82-
ALC4/2015
Party
Name:UNICHEM
LABORATORIES
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00725/AM16/
RLA
File
:03/95/040/00032/AM16/
Lic.No/Date:0310795877
13.05.2015
Defer
Date:18.11.2015
Decision :The committee decided to defer the case for want of comments of DoP.
436
Case
No.:4/3/82-
ALC4/2015
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00034/AM16/
RLA
File
:09/24/040/00082/AM16/
Lic.No/Date:0910062020
14.05.2015
Defer
Date:18.11.2015
Decision :The committee decided to defer the case for want of comments of DoP.
437
Case
No.:5/3/82-
ALC4/2015
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00035/AM16/
RLA
File
:09/24/040/00081/AM16/
Lic.No/Date:0910062019
14.05.2015
Defer
Date:28.10.2015
Decision :The committee decided to defer the case for want of comments of DoP.
438
Case
No.:129/7/82-
ALC4/2015
Party
Name:NATIONAL
TUBE INDUSTRIES,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00734/AM16/
RLA
File
:03/95/040/00073/AM16/
Lic.No/Date:0310795930
14.05.2015
Defer
Date:28.10.2015
Decision :The Committee noted that firm vide letter dated 5.10.2015 has sent information to Shri
O.P. Sharma, Joint Industrial Adviser, DC&PC (Pretrochemical) and copy addressed to DGFT.
The Committee accordingly deferred the case for want of comments from Pretochemicals.
439
Case
No.:127/7/82-
ALC4/2015
Party
Name:NEW
ALLIANCE
DYE-CHEM
PVT. LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00732/AM16/
RLA
File
:03/95/040/00055/AM16/
Lic.No/Date:0310795912
14.05.2015
Defer Date:
Decision : The Committee decided to defer the case for want of comments of DC&PC.
440
Case
No.:128/7/82-
ALC4/2015
Party
Name:RELIANCE
INDUSTRIES LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00733/AM16/
RLA
File
:03/95/040/00013/AM16/
Lic.No/Date:0310795963
15.05.2015
Defer Date:
Decision :In the light of earlier decision taken in meeting no. 02/82 dated 18.4.2013, it was
decided to ratify norms on repeat basis as uploaded along with these minutes or as applied by
the firm whichever is less under para 4.07 of HBP Vol.1. RA may take further action accordingly.
441
Case
No.:6/7/82-
ALC4/2015
Party
Name:SIMPEX
PHARMA PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00611/AM16/
RLA
File
:05/24/040/00564/AM15/
Lic.No/Date:0510394266
15.05.2015
Defer
Date:28.10.2015
Decision :The committee decided to defer the case for want of comments of DoP.
442
Case
No.:164/7/82-
ALC4/2015
Party
Name:ETERNIS
FINE
CHEMICALS
LIMITED,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00769/AM16/
RLA
File
:03/94/040/00026/AM16/
Lic.No/Date:0310795971
18.05.2015
Defer
Date:28.10.2015
Decision :The Committee based on the written comments forwarded by the D/o C&PC,
forwarded vide letter No.14010/57/2015-CH-II dt. 16th Sept. 2015, uploaded along with these
minutes, decided to call for technical information from the firm and deferred the case.
443
Case
No.:143/7/82-
ALC4/2015
Party
Name:MANGALAM
DRUGS
&
ORGANICS
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00748/AM16/
RLA
File
:03/95/040/01094/AM15/
Lic.No/Date:0310795993
18.05.2015
Defer Date:
recommendation of D/o Pharmaceuticals forwarded vide O.M. No. 35011/600/2014-PI(Norms)
dated April, 2015 , uploaded along with these minutes or as applied by the firm whichever is less
under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.
444
Case
No.:126/7/82-
ALC4/2015
Party
Name:SANDOZ
PRIVATE LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00731/AM16/
RLA
File
:03/95/040/00071/AM16/
Lic.No/Date:0310795986
18.05.2015
Defer
Date:28.10.2015
Decision :The committee decided to defer the case for want of comments of DoP.
445
Case
No.:109/7/82-
ALC4/2015
Party
Name:ZIM
LABORATORIES LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00714/AM16/
RLA
File
:03/95/040/00103/AM16/
Lic.No/Date:0310795994
18.05.2015
Defer
Date:28.10.2015
Decision :The committee decided to defer the case for want of comments of DoP.
446
Case
No.:160/7/82-
ALC4/2015
Party
Name:GUJARAT
ORGANICS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00765/AM16/
RLA
File
:03/94/040/00121/AM16/
Lic.No/Date:0310796029
19.05.2015
Defer
Date:18.11.2015
Decision : The Committee decided to ratify norms for the export product based on the
recommendation of D/o C&PC forwarded vide letter no. 14010/11/2013-CH.II dated 30.09.2015 ,
HBP Vol.1. RA concerned may take necessary action as per decision of NC.
447
Case
No.:133/7/82-
ALC4/2015
Party
Name:AARTI
INDUSTRIES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00738/AM16/
RLA
File
:03/94/040/00085/AM16/
Lic.No/Date:0310796048
20.05.2015
Defer
Date:28.10.2015
Decision : The committee decided to defer the case for want of comments of DC&PC
(Petrochemicals)
448
Case
No.:41/7/82-
ALC4/2015
Party
Name:KORES
(INDIA) LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00646/AM16/
RLA
File
:31/83/040/00196/AM15/
Lic.No/Date:3110065441
20.05.2015
Defer
Date:28.10.2015
Decision :The committee decided to defer the case for want of comments of DC&PC
(Chemicals).
449
Case
No.:102/7/82-
ALC4/2015
Party
Name:DYNAMIC
SPECIALITY
CHEMICALS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00707/AM16/
RLA
File
:30/24/040/00006/AM16/
Lic.No/Date:3010103498
21.05.2015
Defer
Date:28.10.2015
Decision :The committee decided to defer the case for want of comments of DC&PC
(Petrochemicals)
450
Case
No.:51/7/82-
ALC4/2015
Party
Name:BHAGIRADHA
CHEMICALS
&
INDUSTRIES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00656/AM16/
RLA
File
:09/24/040/00096/AM16/
Lic.No/Date:0910062060
22.05.2015
Defer
Date:28.10.2015
Decision :The Committee based on the written comments forwarded by the D/o C&PC,
forwarded vide letter No.15022/17/2012-CH-II dt. 16th Sept. 2015, uploaded along with these
minutes, decided to call for technical information from the firm and deferred the case.
451
Case
No.:168/7/82-
ALC4/2015
Party Name:DANOPHARM
CHEMICALS
PRIVATE
LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00773/AM16/
RLA
File
:03/94/040/00102/AM16/
Lic.No/Date:0310796163
22.05.2015
Defer Date:
Decision : The committee decided to defer the case for want of comments of DoP.
452
Case
No.:167/7/82-
ALC4/2015
Party
Name:IPCA
LABORATORIES
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00772/AM16/
RLA
File
:03/94/040/00041/AM16/
Lic.No/Date:0310796129
22.05.2015
Defer
Date:28.10.2015
Decision :The committee decided to defer the case for want of comments of DoP
453
Case
No.:112/7/82-
ALC4/2015
Party
Name:YASHO
INDUSTRIES PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00717/AM16/
RLA
File
:03/95/040/00121/AM16/
Lic.No/Date:0310796157
22.05.2015
Defer
Date:28.10.2015
Decision :The committee decided to defer the case for want of comments of DC&PC
(Chemicals)
454
Case
No.:125/7/82-
ALC4/2015
Party
Name:YASHO
INDUSTRIES PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00730/AM16/
RLA
File
:03/95/040/00120/AM16/
Lic.No/Date:0310796156
22.05.2015
Defer Date:
Decision : The Committee decided to ratify norms for the export product based on the
recommendation of D/o C&PC provided vide U.O.No.14010/95/2011-Ch-II dated 11.09.2015,
HBP
Vol.1.
455
Case
No.:10/7/82-
ALC4/2015
Party
Name:DHANUKA
LABORATORIES LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00615/AM16/
RLA
File
:05/23/040/00057/AM16/
Lic.No/Date:0510394341
25.05.2015
Defer
Date:18.11.2015
Decision : The committee decided to defer the case for want of comments of DoP
456
Case
No.:3/4/82-
ALC4/2015
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00042/AM16/
RLA
File
:09/24/040/00104/AM16/
Lic.No/Date:0910062064
25.05.2015
Defer
Date:28.10.2015
457
Case
No.:13/7/82-
ALC4/2015
Party
Name:MOREPEN
LABORATORIES LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00618/AM16/
RLA
File
:05/24/040/00074/AM16/
Lic.No/Date:0510394343
25.05.2015
Defer
Date:28.10.2015
Decision : The committee decided to defer the case for want of comments of DoP
458 Case No.:170/7/82- Party Name:FERMENTA Meet No/Date:9/82- Status:Case
ALC4/2015
BIOTECH LTD.,
ALC4/2015
30.09.2015
Deferred
HQ
File
:01/82/050/00775/AM16/
RLA
File
:03/94/040/00009/AM16/
Lic.No/Date:0310796191
26.05.2015
Defer
Date:28.10.2015
459
Case
No.:176/7/82-
ALC4/2015
Party
Name:GLOBE
TROTTERS PVT LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00781/AM16/
RLA
File
:03/94/040/00124/AM16/
Lic.No/Date:0310796194
26.05.2015
Defer
Date:30.09.2015
Decision :it was decided to defer the case for want of comments of DC&PC(Chemicals).
460
Case
No.:46/7/82-
ALC4/2015
Party
Name:GLAND
PHARMA LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00651/AM16/
RLA
File
:09/24/040/00709/AM15/
Lic.No/Date:0910062070
26.05.2015
Defer
Date:28.10.2015
461
Case
No.:47/7/82-
ALC4/2015
Party
Name:GLAND
PHARMA LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00652/AM16/
RLA
File
:09/24/040/00712/AM15/
Lic.No/Date:0910062071
26.05.2015
Defer
Date:28.10.2015
462
Case
No.:166/7/82-
ALC4/2015
Party
Name:IPCA
LABORATORIES
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00771/AM16/
RLA
File
:03/94/040/00063/AM16/
Lic.No/Date:0310796196
26.05.2015
Defer
Date:28.10.2015
463
Case
No.:162/7/82-
ALC4/2015
Party
Name:KRISHNA
ANTIOXIDANTS
PVT.
LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00767/AM16/
RLA
File
:03/94/040/00107/AM16/
Lic.No/Date:0310796189
26.05.2015
Defer
Date:28.10.2015
Decision :The committee decided to defer the case for want of comments of
DC&PC(Chemicals).
464
Case
No.:124/7/82-
ALC4/2015
Party
Name:PRIVI
ORGANICS LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00729/AM16/
RLA
File
:03/95/040/00114/AM16/
Lic.No/Date:0310796233
27.05.2015
Defer
Date:28.10.2015
Decision :The committee decided to defer the case for want of comments of
DC&PC(Chemicals).
465
Case
No.:96/7/82-
ALC4/2015
Party
Name:ALEMBIC
PHARMACEUTICALS
LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00701/AM16/
RLA
File
:34/24/040/00035/AM16/
Lic.No/Date:3410041255
28.05.2015
Defer
Date:28.10.2015
466
Case
No.:180/7/82-
ALC4/2015
Party
Name:IND-SWIFT
LABORATORIES LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00785/AM16/
RLA
File
:22/24/040/00007/AM16/
Lic.No/Date:2210015238
25.05.2015
Defer Date:
Decision: The Committee decided to ratify norms for the export product based on the
recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/407/2015-PI(Norms)
dated October, 2015 , uploaded along with these minutes or as applied by the firm whichever is
less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of
NC.
467
Case
No.:100/7/82-
ALC4/2015
Party
Name:SHREE
GANESH
REMEDIES
PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00705/AM16/
RLA
File
:34/24/040/00024/AM16/
Lic.No/Date:3410041261
28.05.2015
Defer
Date:28.10.2015
Decision :The committee decided to defer the case for want of comments of
DC&PC(Chemicals).
468
Case
No.:184/7/82-
ALC4/2015
Party
Name:THEON
PHARMACEUTICALS
LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00789/AM16/
RLA
File
:22/24/040/00009/AM16/
Lic.No/Date:2210015246
28.05.2015
Defer
Date:28.10.2015
469
Case
No.:68/7/82-
ALC4/2015
Party
Name:OPTIMUS
DRUGS PRIVATE LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00673/AM16/
RLA
File
:09/24/040/00061/AM16/
Lic.No/Date:0910062099
29.05.2015
Defer Date:
Decision :The Committee decided to ratify norms for the export product Rosuvastatin Calcium
based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.
35011/227/2015-PI(Norms) dated 29.09.2015, uploaded along with these minutes or as applied
by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary
action as per decision of NC.
470
Case
No.:83/7/82-
ALC4/2015
Party
Name:VIVIMED
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00688/AM16/
RLA
File
:09/24/040/00120/AM16/
Lic.No/Date:0910062089
29.05.2015
Defer Date:
Decision :The Committee decided to ratify norms for the export product Platinum Grey based on
the recommendation of D/o C&PC forwarded vide No. 14010/138/2011-CH-II dated 15.6.2015,
HBP Vol.1. RA concerned may take necessary action as per decision of NC.
471
Case
No.:113/7/82-
ALC4/2015
Party
Name:S.M.
CHEMICALS
Meet
No/Date:7/82-
ALC4/2015
24.07.2015
Status:Case
Deferred
HQ
File
:01/82/050/00718/AM16/
RLA
File
:03/95/040/00115/AM16/
Lic.No/Date:0310796312
29.05.2015
Defer Date:
18.11.2015
Decision :it was decided to defer the case for want of comments of DC&PC(Chemicals).
472
Case
No.:101/7/82-
ALC4/2015
Party
Name:TRANSPEK
INDUSTRY LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00706/AM16/
RLA
File
:34/24/040/00054/AM16/
Lic.No/Date:3410041263
01.06.2015
Defer Date:
Decision :The Committee decided to ratify norms for the export product Octanoyl Chloride
based on the recommendation of D/o C&PC forwarded vide No. 14010/6/2011-CH-II dated
6.10.2015, uploaded along with these minutes or as applied by the firm whichever is less under
para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.
473
Case
No.:188/7/82-
ALC4/2015
Party
Name:ATUL
LIMITED,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00793/AM16/
RLA
File
:08/24/040/00034/AM16/
Lic.No/Date:0810135421
02.06.2015
Defer
Date:28.10.2015
DC&PC(petrochemicals).
474
Case
No.:14/7/82-
ALC4/2015
Party
Name:DHANUKA
LABORATORIES LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00619/AM16/
RLA
File
:05/23/040/00075/AM16/
Lic.No/Date:0510394413
02.06.2015
Defer
Date:28.10.2015
475
Case
No.:5/7/82-
ALC4/2015
Party
Name:SUN
PHARMACEUTICAL
INDUSTRIES LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00610/AM16/
RLA
File
:05/24/040/00090/AM16/
Lic.No/Date:0510394416
02.06.2015
Defer
Date:28.10.2015
476
Case
No.:142/7/82-
ALC4/2015
Party
Name:GLOBE
TROTTERS PVT LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00747/AM16/
RLA
File
:03/94/040/00159/AM16/
Lic.No/Date:0310796401
03.06.2015
Defer
Date:28.10.2015
DC&PC(Chemicals).
477
Case
No.:134/7/82-
ALC4/2015
Party
Name:INDOCO
REMEDIES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00739/AM16/
RLA
File
:03/94/040/00154/AM16/
Lic.No/Date:0310796399
03.06.2015
Defer
Date:28.10.2015
478
Case
No.:163/7/82-
ALC4/2015
Party
Name:INDOCO
REMEDIES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00768/AM16/
RLA
File
:03/94/040/00141/AM16/
Lic.No/Date:0310796397
03.06.2015
Defer Date:
Decision :The Committee decided to ratify norms for the export product Ciprofloxacin
Hydrochloride USP based on the recommendation of D/o Pharmaceuticals forwarded vide No.
35011/490/2014-PI (Norms) dated 09.02.2015, uploaded along with these minutes or as applied
by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary
action as per decision of NC.
479
Case
No.:110/7/82-
ALC4/2015
Party
Name:RISHABH
METALS & CHEMICALS
PVT LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00715/AM16/
RLA
File
:03/95/040/00051/AM16/
Lic.No/Date:0310796383
03.06.2015
Defer
Date:28.10.2015
DC&PC(Petrochemicals).
480
Case
No.:16/7/82-
ALC4/2015
Party
Name:SUN
PHARMACEUTICAL
INDUSTRIES LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00621/AM16/
RLA
File
:05/24/040/00084/AM16/
Lic.No/Date:0510394419
03.06.2015
Defer
Date:28.10.2015
481
Case
No.:17/7/82-
ALC4/2015
Party
Name:SUN
PHARMACEUTICAL
INDUSTRIES LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00622/AM16/
RLA
File
:05/24/040/00078/AM16/
Lic.No/Date:0510394418
03.06.2015
Defer
Date:28.10.2015
482
Case
No.:105/7/82-
ALC4/2015
Party
Name:SAVLA
CHEMICALS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00710/AM16/
RLA
File
:03/95/040/00159/AM16/
Lic.No/Date:0310796432
04.06.2015
Defer
Date:28.10.2015
Decision :The Committee based on the written comments forwarded by the D/o C&PC, letter
No.14010/71/2014-CH-II dated 18.9.2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.
483
Case
No.:187/7/82-
ALC4/2015
Party
Name:ATUL
LIMITED,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00792/AM16/
RLA
File
:08/24/040/00057/AM16/
Lic.No/Date:0810135435
05.06.2015
Defer
Date:28.10.2015
DC&PC(Petrochemicals).
484
Case
No.:62/7/82-
ALC4/2015
Party
Name:EYTAN
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00667/AM16/
RLA
File
:09/24/040/00598/AM15/
Lic.No/Date:0910062137
05.06.2015
Defer
Date:28.10.2015
485
Case
No.:135/7/82-
ALC4/2015
Party
Name:INDOCO
REMEDIES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00740/AM16/
RLA
File
:03/94/040/00153/AM16/
Lic.No/Date:0310796471
05.06.2015
Defer
Date:28.10.2015
486
Case
No.:63/7/82-
ALC4/2015
Party
Name:EYTAN
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00668/AM16/
RLA
File
:09/24/040/00740/AM15/
Lic.No/Date:0910062136
05.06.2015
Defer
Date:18.11.2015
Decision :it was decided to defer the case for want of comments of D/o Chemicals.
487
Case
No.:158/7/82-
ALC4/2015
Party
Name:INDOCO
REMEDIES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00763/AM16/
RLA
File
:03/94/040/00158/AM16/
Lic.No/Date:0310796470
05.06.2015
Defer
Date:18.11.2015
488
Case
No.:67/7/82-
ALC4/2015
Party
Name:OPTIMUS
DRUGS
PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00672/AM16/
RLA
File
:09/24/040/00105/AM16/
Lic.No/Date:0910062138
05.06.2015
Defer
Date:28.10.2015
489
Case
No.:13/9/82-
ALC4/2015
Party
Name:SHILPA
MEDICARE LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File RLA
File Lic.No/Date:0710108327 Defer
:01/82/050/00949/AM16/ :07/24/040/00081/AM16/ 05.06.2015 Date:28.10.2015 Decision :: The Committee decided to defer the case for want of comments of DoP.
490
Case
No.:121/7/82-
ALC4/2015
Party
Name:UNIMARK
REMEDIES LIMITED.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00726/AM16/
RLA
File
:03/95/040/00715/AM15/
Lic.No/Date:0310796458
05.06.2015
Defer
Date:28.10.2015
491
Case
No.:123/7/82-
ALC4/2015
Party
Name:UNIMARK
REMEDIES LIMITED.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00728/AM16/
RLA
File
:03/95/040/00582/AM15/
Lic.No/Date:0310796457
05.06.2015
Defer
Date:28.10.2015
492
Case
No.:97/7/82-
ALC4/2015
Party
Name:ALEMBIC
PHARMACEUTICALS
LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00702/AM16/
RLA
File
:34/24/040/00062/AM16/
Lic.No/Date:3410041281
09.06.2015
Defer
Date:28.10.2015
493
Case
No.:95/7/82-
ALC4/2015
Party
Name:AMI
LIFESCIENCES P LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00700/AM16/
RLA
File
:34/24/040/00064/AM16/
Lic.No/Date:3410041285
09.06.2015
Defer Date:
Decision :The Committee decided to ratify norms for the export product Aloe Emodin-95%
based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/59/2012-
PI(Norms) dated6.6.2012 , uploaded along with these minutes or as applied by the firm
whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per
decision of NC.
494
Case
No.:136/7/82-
ALC4/2015
Party
Name:J.B.
CHEMICALS
&
PHARMACEUTICALS
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00741/AM16/
RLA
File
:03/94/040/00032/AM16/
Lic.No/Date:0310796511
09.06.2015
Defer
Date:28.10.2015
DC&PC(Chemicals).
495
Case
No.:85/7/82-
ALC4/2015
Party Name:SHREEGEN
PHARMA LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00690/AM16/
RLA
File
:09/24/040/00130/AM16/
Lic.No/Date:0910062145
09.06.2015
Defer
Date:28.10.2015
DC&PC(Chemicals).
496
Case
No.:122/7/82-
ALC4/2015
Party
Name:UNIMAX
CHEMICALS PVT LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Rejected
HQ
File
:01/82/050/00727/AM16/
RLA
File
:03/95/040/00154/AM16/
Lic.No/Date:0310796500
09.06.2015
Defer Date:
Decision :In view of the facts brough to the notice by DoP, the case was rejected, copy of DoP
O.M. No. 35011/315/2014-PI (norms) dated 30.09.2015 uploaded alongwith these minutes.
497
Case
No.:59/7/82-
ALC4/2015
Party Name:GRANULES
INDIA LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00664/AM16/
RLA
File
:09/24/040/00149/AM16/
Lic.No/Date:0910062152
10.06.2015
Defer
Date:18.11.2015
Decision :it was decided to defer the case for want of comments of DC&PC(Chemicals).
498
Case
No.:60/7/82-
ALC4/2015
Party Name:GRANULES
INDIA LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00665/AM16/
RLA
File
:09/24/040/00126/AM16/
Lic.No/Date:0910062150
10.06.2015
Defer
Date:28.10.2015
DC&PC(Chemicals).
499
Case
No.:61/7/82-
ALC4/2015
Party Name:GRANULES
INDIA LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00666/AM16/
RLA
File
:09/24/040/00141/AM16/
Lic.No/Date:0910062149
10.06.2015
Defer
Date:28.10.2015
Decision :: The Committee decided to defer the case for want of comments of
DC&PC(Chemicals).
500
Case
No.:137/7/82-
ALC4/2015
Party
Name:J.B.
CHEMICALS
&
PHARMACEUTICALS
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00742/AM16/
RLA
File
:03/94/040/00074/AM16/
Lic.No/Date:0310796546
10.06.2015
Defer
Date:28.10.2015
DC&PC(Chemicals).
501
Case
No.:182/7/82-
ALC4/2015
Party
Name:SAURAV
CHEMICALS LTD,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00787/AM16/
RLA
File
:22/24/040/00006/AM16/
Lic.No/Date:2210015251
10.06.2015
Defer
Date:28.10.2015
DC&PC(Chemicals).
502 Case
No.:14/9/82-
ALC4/2015
Party
Name:SHILPA
MEDICARE LTD.,
Meet
No/Date:9/82-
ALC4/2015
Status:Case
Deferred
30.09.2015
HQ
File
:01/82/050/00950/AM16/
RLA
File
:07/24/040/00078/AM16/
Lic.No/Date:0710108349
10.06.2015
Defer
Date:28.10.2015
503
Case
No.:65/7/82-
ALC4/2015
Party
Name:VIVIMED
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00670/AM16/
RLA
File
:09/24/040/00164/AM16/
Lic.No/Date:0910062163
10.06.2015
Defer
Date:28.10.2015
504
Case
No.:66/7/82-
ALC4/2015
Party
Name:VIVIMED
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00671/AM16/
RLA
File
:09/24/040/00162/AM16/
Lic.No/Date:0910062162
10.06.2015
Defer
Date:28.10.2015
505
Case
No.:159/7/82-
ALC4/2015
Party
Name:VIJAY
PERFUMES PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00764/AM16/
RLA
File
:03/95/040/00985/AM15/
Lic.No/Date:0310796576
11.06.2015
Defer
Date:28.10.2015
DC&PC(Chemicals).
506
Case
No.:87/7/82-
ALC4/2015
Party
Name:VISION
DRUGS PVT LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00692/AM16/
RLA
File
:09/24/040/00102/AM16/
Lic.No/Date:0910062168
11.06.2015
Defer
Date:28.10.2015
507
Case
No.:177/7/82-
ALC4/2015
Party
Name:S.M.
CHEMICALS
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00782/AM16/
RLA
File
:03/95/040/00124/AM16/
Lic.No/Date:0310796577
11.06.2015
Defer
Date:28.10.2015
Decision :it was decided to defer the case for want of comments of DC&PC(Chemicals).
508
Case
No.:88/7/82-
ALC4/2015
Party
Name:S
M
S
PHARMACEUTICALS
LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00693/AM16/
RLA
File
:09/24/040/00152/AM16/
Lic.No/Date:0910062179
12.06.2015
Defer
Date:18.11.2015
509
Case
No.:171/7/82-
ALC4/2015
Party
Name:MAKSON
INDUSTRIES PVT. LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00776/AM16/
RLA
File
:03/95/040/01080/AM15/
Lic.No/Date:0310796624
15.06.2015
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments of MSME
510
Case
No.:172/7/82-
ALC4/2015
Party
Name:MAKSON
INDUSTRIES PVT. LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00777/AM16/
RLA
File
:03/95/040/01079/AM15/
Lic.No/Date:0310796623
15.06.2015
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments of MSME.
511
Case
No.:189/7/82-
ALC4/2015
Party
Name:MOREPEN
LABORATORIES LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00794/AM16/
RLA
File
:05/24/040/00116/AM16/
Lic.No/Date:0510394560
15.06.2015
Defer
Date:18.11.2015
512
Case
No.:54/7/82-
ALC4/2015
Party
Name:HPL
ADDITIVES
LIMITED(FORMERLY
KNOWN
HIGH
POLYMER
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00659/AM16/
RLA
File
:05/23/040/00065/AM16/
Lic.No/Date:0510394575
16.06.2015
Defer
Date:28.10.2015
DC&PC(Chemicals).
513
Case
No.:55/7/82-
ALC4/2015
Party
Name:HPL
ADDITIVES
LIMITED(FORMERLY
KNOWN
HIGH
POLYMER
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00660/AM16/
RLA
File
:05/23/040/00030/AM16/
Lic.No/Date:0510394579
16.06.2015
Defer
Date:28.10.2015
DC&PC(Chemicals).
514
Case
No.:52/7/82-
ALC4/2015
Party
Name:JODAS
EXPOIM PVT.LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00657/AM16/
RLA
File
:05/23/040/00107/AM16/
Lic.No/Date:0510394590
17.06.2015
Defer
Date:28.10.2015
DC&PC(Chemicals).
515 Case
No.:53/7/82-
ALC4/2015
Party
Name:JODAS
EXPOIM PVT.LTD.,
Meet
No/Date:9/82-
ALC4/2015
Status:Case
Deferred
30.09.2015
HQ
File
:01/82/050/00658/AM16/
RLA
File
:05/23/040/00115/AM16/
Lic.No/Date:0510394591
17.06.2015
Defer
Date:28.10.2015
DC&PC(Chemicals).
516
Case
No.:86/7/82-
ALC4/2015
Party Name:RA CHEM
PHARMA LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00691/AM16/
RLA
File
:09/24/040/00160/AM16/
Lic.No/Date:0910062204
17.06.2015
Defer
Date:28.10.2015
517
Case
No.:190/7/82-
ALC4/2015
Party
Name:SUN
PHARMACEUTICAL
INDUSTRIES LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00795/AM16/
RLA
File
:05/24/040/00105/AM16/
Lic.No/Date:0510394617
17.06.2015
Defer
Date:28.10.2015
518
Case
No.:43/7/82-
ALC4/2015
Party
Name:LEE
PHARMA LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00648/AM16/
RLA
File
:09/24/040/00142/AM16/
Lic.No/Date:0910062210
18.06.2015
Defer
Date:18.11.2015
519
Case
No.:15/9/82-
ALC4/2015
Party Name:KDAC CHEM
PVT LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00951/AM16/
RLA
File
:34/24/040/00069/AM16/
Lic.No/Date:3410041310
22.06.2015
Defer
Date:28.10.2015
DC&PC(Chemicals).
520
Case
No.:183/7/82-
ALC4/2015
Party
Name:SAURAV
CHEMICALS LTD,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00788/AM16/
RLA
File
:22/24/040/00010/AM16/
Lic.No/Date:2210015259
22.06.2015
Defer
Date:28.10.2015
DC&PC(Chemicals).
521
Case
No.:84/7/82-
ALC4/2015
Party Name:SUVEN LIFE
SCIENCES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00689/AM16/
RLA
File
:09/24/040/00169/AM16/
Lic.No/Date:0910062232
23.06.2015
Defer
Date:18.11.2015
522
Case
No.:45/7/82-
ALC4/2015
Party
Name:EYTAN
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00650/AM16/
RLA
File
:09/24/040/00135/AM16/
Lic.No/Date:0910062250
24.06.2015
Defer
Date:28.10.2015
523
Case
No.:64/7/82-
ALC4/2015
Party Name:TRIMAX BIO
SCIENCES
PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00669/AM16/
RLA
File
:09/24/040/00133/AM16/
Lic.No/Date:0910062246
24.06.2015
Defer
Date:28.10.2015
DC&PC(Chemicals).
524
Case
No.:48/7/82-
ALC4/2015
Party
Name:MYLAN
LABORATORIES
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00653/AM16/
RLA
File
:09/24/040/00118/AM16/
Lic.No/Date:0910062253
25.06.2015
Defer
Date:28.10.2015
525
Case
No.:27/7/82-
ALC4/2015
Party
Name:PANACEA
BIOTEC LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00632/AM16/
RLA
File
:05/24/040/00146/AM16/
Lic.No/Date:0510394710
25.06.2015
Defer
Date:28.10.2015
Decision :Decision : The Committee decided to defer the case for want of comments of DBT
526
Case
No.:72/7/82-
ALC4/2015
Party Name:PCL OIL &
SOLVENTS LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00677/AM16/
RLA
File
:05/24/040/00104/AM16/
Lic.No/Date:0510394704
25.06.2015
Defer
Date:28.10.2015
Decision :The Committee based on the written comments forwarded by the D/o C&PC, vide
letter No.46011/88/2008-PC-II dt. 16.09.2015 2015, uploaded along with these minutes decided
to call for technical information from the firm and deferred the case.
527
Case
No.:76/7/82-
ALC4/2015
Party Name:PCL OIL &
SOLVENTS LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00681/AM16/
RLA
File
:05/24/040/00103/AM16/
Lic.No/Date:0510394703
25.06.2015
Defer
Date:28.10.2015
Decision :The Committee based on the written comments forwarded by the D/o C&PC, vide
letter No.46011/88/2008-PC-II dt. 16.09.2015 2015, uploaded along with these minutes decided
to call for technical information from the firm and deferred the case.
528
Case
No.:75/7/82-
ALC4/2015
Party
Name:SENTISS
PHARMA PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File RLA
File Lic.No/Date:0510394696 Defer
:01/82/050/00680/AM16/ :05/24/040/00122/AM16/ 25.06.2015 Date:28.10.2015
529
Case
No.:78/7/82-
ALC4/2015
Party
Name:WEST
BENGAL
CHEMICAL
INDUSTRIES LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00683/AM16/
RLA
File
:02/24/040/00028/AM16/
Lic.No/Date:0210205920
25.06.2015
Defer
Date:28.10.2015
DC&PC(Chemicals).
530
Case
No.:89/7/82-
ALC4/2015
Party
Name:HALDIA
PETROCHEMICALS
LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00694/AM16/
RLA
File
:02/24/040/00045/AM16/
Lic.No/Date:0210205925
26.06.2015
Defer
Date:28.10.2015
Decision :The Committee based on the written comments forwarded by the D/o C&PC, vide
letter No.46011/54/2008-PC-II dt. 16.09.2015 2015, uploaded along with these minutes decided
to call for technical information from the firm and deferred the case.
531
Case
No.:77/7/82-
ALC4/2015
Party
Name:SENTISS
PHARMA PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00682/AM16/
RLA
File
:05/24/040/00130/AM16/
Lic.No/Date:0510394732
26.06.2015
Defer
Date:28.10.2015
532
Case
No.:26/7/82-
ALC4/2015
Party
Name:SOFTGEL
HEALTH
CARE
PVT.
LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00631/AM16/
RLA
File
:04/24/040/00072/AM16/
Lic.No/Date:0410160709
26.06.2015
Defer
Date:28.10.2015
533
Case
No.:181/7/82-
ALC4/2015
Party
Name:CLARION
DRUGS LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00786/AM16/
RLA
File
:50/24/040/00002/AM16/
Lic.No/Date:5010002211
29.06.2015
Defer
Date:28.10.2015
534
Case
No.:57/7/82-
ALC4/2015
Party
Name:KLJ
PLASTICIZERS LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00662/AM16/
RLA
File
:05/23/040/00112/AM16/
Lic.No/Date:0510394740
29.06.2015
Defer
Date:28.10.2015
DC&PC(Petrochemical)
535 Case No.:58/7/82- Party Name:KLJ Meet No/Date:9/82- Status:Case
ALC4/2015
PLASTICIZERS LTD.,
ALC4/2015
30.09.2015
Deferred
HQ
File
:01/82/050/00663/AM16/
RLA
File
:05/23/040/00111/AM16/
Lic.No/Date:0510394739
29.06.2015
Defer
Date:28.10.2015
Decision :it was decided to defer the case for want of comments of D DC&PC(Petrochemical)
536
Case
No.:44/7/82-
ALC4/2015
Party
Name:LEE
PHARMA LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00649/AM16/
RLA
File
:09/24/040/00201/AM16/
Lic.No/Date:0910062263
30.06.2015
Defer
Date:28.10.2015
537
Case
No.:69/7/82-
ALC4/2015
Party
Name:PAYAL
PETROCHEM
PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00674/AM16/
RLA
File
:05/24/040/00048/AM16/
Lic.No/Date:0510394756
30.06.2015
Defer Date:
recommendation of D/o C&PC provided vide U.O.No.46011/79/2014-Ch-II dated 26.08.2015 ,
538
Case
No.:70/7/82-
ALC4/2015
Party
Name:PAYAL
PETROCHEM
PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00675/AM16/
RLA
File
:05/24/040/00075/AM16/
Lic.No/Date:0510394758
30.06.2015
Defer Date:
recommendation of D/o C&PC provided vide U.O.No.46011/79/2014-Ch-II dated 26.08.2015 ,
539
Case
No.:71/7/82-
ALC4/2015
Party
Name:PAYAL
PETROCHEM
PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00676/AM16/
RLA
File
:05/24/040/00076/AM16/
Lic.No/Date:0510394759
30.06.2015
Defer Date:
recommendation of D/o C&PC provided vide U.O.No.46011/79/2014-Ch-II dated 26.08.2015 ,
540
Case
No.:73/7/82-
ALC4/2015
Party
Name:PAYAL
PETROCHEM
PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00678/AM16/
RLA
File
:05/24/040/00083/AM16/
Lic.No/Date:0510394760
30.06.2015
Defer Date:
recommendation of D/o C&PC provided vide U.O.No.46011/79/2014-Ch-II dated 26.08.2015 ,
541
Case
No.:74/7/82-
ALC4/2015
Party
Name:PAYAL
PETROCHEM
PRIVATE
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00679/AM16/
RLA
File
:05/24/040/00068/AM16/
Lic.No/Date:0510394757
30.06.2015
Defer Date:
recommendation of D/o C&PC provided vide U.O.No.46011/79/2014-Ch-II dated 26.08.2015 ,
542
Case
No.:42/7/82-
ALC4/2015
Party
Name:CLEAN
SCIENCE
AND
TECHNOLOGY
PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00647/AM16/
RLA
File
:31/83/040/00030/AM16/
Lic.No/Date:3110065521
01.07.2015
Defer
Date:28.10.2015
DC&PC(Chemicals)
543
Case
No.:2/7/82-
ALC4/2015
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00607/AM16/
RLA
File
:09/24/040/00213/AM16/
Lic.No/Date:0910062316
08.07.2015
Defer
Date:28.10.2015
544
Case
No.:3/7/82-
ALC4/2015
Party Name:DR REDDYS
LABORATORIES
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00608/AM16/
RLA
File
:09/24/040/00202/AM16/
Lic.No/Date:0910062341
16.07.2015
Defer
Date:18.11.2015
545
Case
No.:185/7/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00790/AM16/
RLA
File
:09/24/040/00219/AM16/
Lic.No/Date:0910062355
21.07.2015
Defer
Date:28.10.2015
546
Case
No.:186/7/82-
ALC4/2015
Party
Name:SHREE
BANKEY
BEHARI
LAL
BOARD MILLS
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00791/AM16/
RLA
File
:05/24/040/00171/AM16/
Lic.No/Date:0510395025
21.07.2015
Defer Date:
Decision :The Committee decided to ratify norms for the export product Menthol based on the
recommendation of D/o C&PC provided vide U.O.No.14010/28/2012-CH-II dated 30.09.2015 ,
HBP
Vol.1.
547
Case
No.:6/9/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00942/AM16/
RLA
File
:09/24/040/00318/AM16/
Lic.No/Date:0910062572
08.09.2015
Defer
Date:18.11.2015
548
Case
No.:7/9/82-
ALC4/2015
Party Name:DR REDDYS
LABORATORIES
LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00943/AM16/
RLA
File
:09/24/040/00312/AM16/
Lic.No/Date:0910062574
08.09.2015
Defer
Date:28.10.2015
549
Case
No.:3/9/82-
ALC4/2015
Party
Name:HETERO
DRUGS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00939/AM16/
RLA
File
:09/24/040/00341/AM16/
Lic.No/Date:0910062565
08.09.2015
Defer
Date:28.10.2015
550
Case
No.:4/9/82-
ALC4/2015
Party
Name:HETERO
DRUGS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00940/AM16/
RLA
File
:09/24/040/00338/AM16/
Lic.No/Date:0910062566
08.09.2015
Defer
Date:28.10.2015
551
Case
No.:5/9/82-
ALC4/2015
Party
Name:HETERO
DRUGS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00941/AM16/
RLA
File
:09/24/040/00337/AM16/
Lic.No/Date:0910062567
08.09.2015
Defer
Date:28.10.2015
552
Case
No.:2/9/82-
ALC4/2015
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00938/AM16/
RLA
File
:09/24/040/00344/AM16/
Lic.No/Date:0910062564
08.09.2015
Defer
Date:28.10.2015
Decision : The Committee decided to defer the case for want of comments of DoP.
553
Case
No.:1/9/82-
ALC4/2015
Party
Name:OPTIMUS
DRUGS PRIVATE LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Approved
HQ
File
:01/82/050/00937/AM16/
RLA
File
:09/24/040/00316/AM16/
Lic.No/Date:0910062562
08.09.2015
Defer Date:
Decision : The Committee decided to ratify norms for the export product Rosuvastatin Calcium
based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No. 35011/227/2015-PI(Norms) dated 29.09.2015, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.
554
Case
No.:8/9/82-
ALC4/2015
Party
Name:BEST
VALUE CHEM PVT. LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00944/AM16/
RLA
File
:34/24/040/00155/AM16/
Lic.No/Date:3410041496
09.09.2015
Defer
Date:28.10.2015
DC&PC(Chemicals)
555
Case
No.:10/9/82-
ALC4/2015
Party
Name:ALKYL
AMINES
CHEMICALS
LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00946/AM16/
RLA
File
:03/94/040/00355/AM16/
Lic.No/Date:0310798806
10.09.2015
Defer
Date:28.10.2015
DC&PC(Chemicals)
556
Case
No.:9/9/82-
ALC4/2015
Party
Name:DIVIS
PHARMACEUTICALS
PRIVATE LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00945/AM16/
RLA
File
:09/24/040/00354/AM16/
Lic.No/Date:0910062585
10.09.2015
Defer
Date:18.11.2015
557
Case
No.:12/9/82-
ALC4/2015
Party
Name:ALKYL
AMINES
CHEMICALS
LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00948/AM16/
RLA
File
:03/94/040/00372/AM16/
Lic.No/Date:0310798878
14.09.2015
Defer
Date:28.10.2015
DC&PC(Chemicals)
558
Case
No.:11/9/82-
ALC4/2015
Party
Name:DIVIS
LABORATORIES LTD.,
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00947/AM16/
RLA
File
:09/24/040/00348/AM16/
Lic.No/Date:0910062620
14.09.2015
Defer
Date:18.11.2015
Decision : The Committee decided to defer the case for want of comments of DoP.
559
Case
No.:16/9/82-
ALC4/2015
Party
Name:ALKYL
AMINES
CHEMICALS
LTD
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00952/AM16/
RLA
File
:03/94/040/00265/AM16/
Lic.No/Date:0310798923
16.09.2015
Defer
Date:28.10.2015
Decision :The Committee decided to defer the case for want of comments of DC&PC
560
Case
No.:18/9/82-
ALC4/2015
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00954/AM16/
RLA
File
:09/24/040/00368/AM16/
Lic.No/Date:0910062629
16.09.2015
Defer
Date:28.10.2015
561
Case
No.:19/9/82-
ALC4/2015
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00955/AM16/
RLA
File
:09/24/040/00369/AM16/
Lic.No/Date:0910062630
16.09.2015
Defer
Date:28.10.2015
562
Case
No.:17/9/82-
ALC4/2015
Party
Name:HONOUR
LAB LIMITED
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00953/AM16/
RLA
File
:09/24/040/00371/AM16/
Lic.No/Date:0910062628
16.09.2015
Defer
Date:28.10.2015
Decision :Information called for from firm is awaited.
563
Case
No.:20/9/82-
ALC4/2015
Party Name:SUPREET
CHEMICALS PVT.LTD.
Meet
No/Date:9/82-
ALC4/2015
30.09.2015
Status:Case
Deferred
HQ
File
:01/82/050/00956/AM16/
RLA
File
:03/95/040/00424/AM16/
Lic.No/Date:0310798995
22.09.2015
Defer
Date:28.10.2015
DC&PC(Chemicals)
Manual Minutes of NC-III Meeting No.09/82/2015 Scheduled to be held on 30.09.2015 but actually held on 9.10.2015
Case No. B- 01
M.No.09/16 Date 30.09.2015
M/s. Piramal Enterprises Ltd File No. 01/82/50/00459/AM-14 RLA No.03/95/040/00948/AM13 Adv.Auth. No. 0310742181 dt. 19.07.2013
Decision: The Committee considered the case for revision of norms. The Committee decided revise quantity of import item no.1 with 2% wastes as per SION without any change in the norms already ratified.
RA may take necessary action as per decision of NC.
Case No. B- 02
M.No.09/16 Date 30.09.2015
M/s. Micro Lab Ltd File No. 01/82/50/00015/AM-15 RLA No.07/24/040/00318/AM14 Adv.Auth. No. 0710100791 dt. 23.12.2013
Decision: The Committee considered the case for ratification of norms as per agenda and decided to send a copy of application to DOP and deferred the case.
Case No. B- 03
M.No.09/16 Date 30.09.2015
M/s. Krishna Antioxidants Pvt Ltd File No. 01/82/50/00262/AM-13 RLA No.03/94/040/00004/AM13 Adv.Auth. No. 0310695086 dt. 17.05.2012
Decision: The Committee considered the case for correction in the description of export product as per agenda. The committee decided to correct the description of export product to read as “Di Phenyl Isodecyl Phosphite” without any other changes in the norms already decided.
RA may take necessary action as per decision of NC.
Case No. B- 04
M.No.09/16 Date 30.09.2015
M/s. Aurobindo Pharma Ltd File No. 01/82/50/00578/AM-14 RLA No.09/24/040/00109/AM14 Adv.Auth. No. 0910056486 dt. 27.06.2013
Decision: The Committee considered the case for correction in UOM “kg./kg” mentioned in import items as per agenda. The Committee decided to correct UOM of import items to read as “kg”. RA may take necessary action as per decision of NC.
Case No. B- 05
M/s. Atlas Fine Chemicals Pvt Ltd
M.No.09/16 Date 30.09.2015
File No. 01/82/50/00457/AM-15 RLA No.03/94/040/01049/AM14 Adv.Auth. No. 0310773108 dt. 05.03.2014 Decision: The Committee considered the case for modification of norms as per agenda. The Committee decided to examine the case on file. If the norms were according to consumption data, no need to review.
Case No. B- 06
M.No.09/16 Date 30.09.2015
M/s. Atlas Fine Chemicals Pvt Ltd File No. 01/82/50/00161/AM-15 RLA No.03/94/040/00647/AM14 Adv.Auth. No. 0310763403 dt. 26.12.2013
Decision: The Committee considered the case for modification of norms as per agenda. The Committee decided to examine the case on file. If the norms were according to consumption data, no need to review.
Case No. B- 07
M.No.09/16 Date 30.09.2015
M/s. Atlas Fine Chemicals Pvt Ltd File No. 01/82/50/00463/AM-15 RLA No.03/94/040/00838/AM14 Adv.Auth. No. 0310771877 dt. 25.02.2014
Decision: The Committee considered the case for modification of norms as per agenda. The Committee decided to examine the case on file. If the norms were according to consumption data, no need to review.
Case No. B- 08
M.No.09/16 Date 30.09.2015
M/s. Atlas Fine Chemie Pvt Ltd File No. 01/82/50/00360/AM-14 RLA No.03/94/040/00845/AM13 Adv.Auth. No. 0310732910 dt. 30.04.2013
Decision: The Committee considered the case for modification of norms as per agenda. The Committee decided to examine the case on file. If the norms were according to consumption data, no need to review.
Case No. B- 09
M.No.09/16 Date 30.09.2015
M/s. Generix Chemie (I) Pvt Ltd File No. 01/82/50/00537/AM-06 RLA No.03/94/040/00571/AM06 Adv.Auth. No. 0310343371 dt. 18.08.2015
Decision: The Committee considered the case for revision of norms as per agenda. The representative of Department of C&PC explained to the committee the reasons for which revised norms increasing the wastages have been recommended by the Department of C&PC. He informed that the product is exclusive, there is no comparative data & the tecnonology was provided by the buyer. Placing reliance on the same, the Committee decided to ratify norms based on the recommendation of DC&PC provided vide U.O.No.14010/29/2015-Ch-II dt.02.09.2015, uploaded along with these minutes or as applied by the firm whichever is less
under para 4.07 of HBP Vol.1.
Case No. B- 10
M.No.09/16 Date 30.09.2015
M/s. Yashashvi Rasayan Pvt Ltd File No. 01/82/50/00224/AM-15 File No. 01/82/50/00205/AM-15 RLA No.52/24/040/00022/AM14 RLA No. 52/24/040/00045/AM14 Adv.Auth. No. 5210040190 dt. 12.09.2013 Adv Auth. No. 5210040666 dt. 03.02.2014
Decision: The Committee considered the case for revision of norms as per agenda. The representative of Department of C&PC explained to the committee the reasons for which revised norms increasing the wastages have been recommended by the Department of C&PC. He informed that the product is exclusive, there is no comparative data & the tecnonology was provided by the buyer. The yield has also been compared to the yield in US patents. Placing reliance on the same, the Committee decided to ratify norms based on the recommendation of DC&PC provided vide U.O.No.14010/36/2011-Ch-II dt. 14.07.2015, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.
Case No. B- 11
M.No.09/16 Date 30.09.2015
M/s. Pregna International Ltd File No. 01/82/50/00548/AM-14 RLA No.03/95/040/00335/AM14 Adv.Auth. No. 0310743681 dt. 01.08.2013
Decision: The Committee considered the case for correction UOM of export product from kg. to Number and correction import item as per agenda.
The Committee decided to correct the UOM of export product “Intra Uterine contraceptive Device –CU 380 AG – Qty. 1 Number” .
Case No. B- 12
M.No.09/16 Date 30.09.2015
M/s. Softgel Healthcare Pvt Ltd File No. 01/82/50/00862AM-14 RLA No.04/24/040/00100/AM14 Adv.Auth. No. 0410149961 dt. 18.09.2013
Decision: The Committee considered the for ratification of norms as per agenda and decided to call for copy of Shipping Bill and any other Customs attested documents reflecting grade of import i.e. whether USP or not and deferred the case.
Case No. B- 13
M.No.09/16 Date 30.09.2015 M/s. Pregna International Ltd File No. 01/82/50/00347AM-14 RLA No.03/95/040/00071AM14
Adv.Auth. No. 0310733040 dt. 01.05.2013
Decision: The Committee considered the case for revision of norms and correction UOM of export product “Intra Uterine contraceptive Device –CU 380 AG from kg. to Number” as per agenda.
The Committee decided to correct the UOM of export product to read as “Intra Uterine contraceptive Device –CU 380 AG – 1 Number”.
Case No. B- 14
M.No.09/16 Date 30.09.2015
M/s. United Biotech Pvt Ltd File No. 01/82/50/01150AM-13 RLA No.05/24/040/00448AM13 Adv.Auth. No. 0510347967 dt. 01.03.2013
Decision: The Committee considered the case for ratification of norms as per agenda and decided to send a copy of application to DOP and deferred the case.
Case No. B- 15
M.No.09/16 Date 30.09.2015
M/s. Softgel Healthcare Pvt Ltd File No. 01/82/50/00404AM-15 RLA No.04/24/040/00031AM15 Adv.Auth. No. 0410159058 dt. 22.07.2014
Decision: The Committee considered the case for ratification of norms as per agenda. The
committee noted that import item name does not match with the composition given in the DML.
Therefore, case could not be considered.
Case No. B- 16
M.No.09/16 Date 30.09.2015
M/s. Pregna International Ltd File No. 01/82/50/00460AM-14 RLA No.03/95/040/00264AM14 Adv. Auth. No. 0310740295 dt. 04.07.2013
Decision: The Committee considered the case for correction in the UOM of export product and revision of norms as per agenda.
The Committee decided to correct the UOM of export product to read as “Intra Uterine
Contraceptive Device – Copper T 380 A with safe load – Qty. 1-Number”.
RA may take further necessary action as NC decision.
） ‐ ‐＼ ヽ Government of lndia Ministry of Chemicals and Fertilizers Department of Chemicals and Petrochemicals Subject Advance Aulhorizalion application from M/s. Shiva Pharmachem Ltd., for the import of raw-materials against the export of lsononanoyl Chloride. Ref: U.O. No. 01/82050/1571 AM- l6loES-A42 dated 1 1.6.2015 M/s. Shiva Pharmachem Ltd., have submitted present application for lhe import o, raw material againsl the export of lsononanoyl Chloride The application has been examined and the DepartmEnt recommenda the following norms for the present Advance Authorization application. 4 1tem of ExpOrt Qty Item of lmport Qtv lsononanoyl Chloride l k9 lsononanoic Acid 0 942 kg Thionyl Chloride 0 578 kg Tnis issues with the approval of competent authority. (A K ACARWAL) AddL industr al Adviser TOI No 011‐ 23381430 ShH Mahender V kram Sinqh FTDO(DESllい 0/o DGFT Udvoq Bhawan New Delhi-11 Deptt of C&PC U O No 14010′ 16472011‐ CHJl datedゞ′102015
/ Ollice Memorandunr Subiecl: - lixatiolt ofnorols under para.l.7 of tlanrl Book ol'pr-oceclures (Vol.l)2009-l-l Casc of M/s Mylan Labs Ltd. The undersigncd is directcd to relcr to DGI]T U.O.No.0l/82/j0/t501/ANI IjlDIlS l/1i97 dared thc ll/01/15 vide whioh applicatioll lionr M/s. MylaI Labs Lrd was scnr to rhis Depa(rnellt fbr fixatiolt ol ltouns under pala:4.7 IbI the export ot_ Clind:tnllcin palntitxte Hcl rhis dcparlrnert has examined the matter and the lollowing rorurs arc iirrnishcd unclcr pala4.7 oflland Book of I)rocedures (Vol.1) 2009-14:- F. No.350l l/22912015-PI (Norms) Govemment of India Ministry of Chemicals & Fer.tilizers Department of Pharnraceuticals ) lc $,4' Udyog Bharvan,New Delhi. Dated the o? Ocrober. 2015 l1A0\r"^+S,l^ (Bamali KhastgYr) Under Secretary to the Government oflndia Phoner2307l162 S. No. Import ltem Qty. Reconrnlended kg/kg. 1 SlindanyciD Hcl 1 288 つ Cyclohexane 0300 D Iirlueue 0493 4 {cetolle 2665 ぐ リ Dichloromethane 1 866 ´ ０ Pyddire 0060 ＾ ／ Palmitoyl Chloride 1227 ヽ \y'ethaDol 0200 9 Acetonitrile 2332 10 Dimethyl Fornanride 0133 Directorale General of Foreign Tradc, Department of Comnlerce. (ShLi M.V. Shgh, FTDO). [Jdyog Bhawan, New Delhi
/
F. No.350l t/200/2015-pt (Norms)
^
Govemmenr of India
"
Minisrry ofClrenricals & Fenrlizers il y',
Depanmerrt oI pharrrrrceuticals /
Udyog Bhawan.New Delhi.
Dated the ll September. 2015
Oflice Meuqrandum
Subiect: - Fixation of ,ror,r.,nd". puilliEiii-diil
o )roccdur(s (vol.l) 2009-l4 Casc
of M/s Oplimus Drugs Pvt Ltd.
The undersigned is dirccted to ref'er to DGFT U.O.No. 0l /g2l50/ I 503/AM- 15/DES_
i/l394 dated the 1 l/01/15 vide whiclr applicarion from M/s. Optinus DrLrgs p-t Ltd was serlt to
this Dcpatment for lixation of nomt under para: 4.7 loi the expori of Linezolid. This
department has examined the natter and the lollowing norits ar(] furnishccl undcr para 4.7 of
Hand Book ofProcedur.es (Vol.l) 2009-14:-
S No
Import Itenr
Qty. Recommended kg/kg.
1
3,4-Di fl uoronilr obenzene
09324
＾
Ｚ
Methanol
7 75 1it
IR)‐ ()2(Ch101olncthyりOXilallc
0 80 kykg
4
N,N(OR)1,l CarbOnyI Diimidazolc
0747
Dircctoratc Ccncral of Foreign Tradc,
DepZartmcllt ofCOmmcrcc,
(Shrl M V Singh,FTDO).
Udyog Bllawan,Ncw Delhi
(Wu^o"Sq;
(Bamali Khaslgir)
Under Secretary to the Govemment oflndia
Phone:23071162
F No 35011405/2015 PI oヾ orl1lS) % Covernntcnt of lndia / Ministry of Chenrrcals & Fertilizels .1" >,., Depanrlenr o[ Pharmaceuricrls < ^ -,r' J"/. LIdyog Blrawan.Nerv Delhi. r).,rcd (hc os Dlfff,.:nr: Olllce Memorandum Subjectr - Fixalion of no|ms under par.a 4.7 ol lland Book oI pr.ocedLrrcs (Vol.l) 2009-14 Casc of M/s Srini Phflrma Ltd. The undersigncrl is directed to refer to DG|'T U.O.No. 0l/82/50/ I 504/AM- l 5/DBS. l/556 dated the l0l07/li vide which applicarion from M/s. Srini pharma Lrd was scnr to rhrs Department fo, iixation ol nomrs under pala: 4.7 for the expor.t ofLevolloxacin Hemihldrntc. 'l'his departmenl has exan'titred the malcr and thc lollo,rl,.ing norms arc lirrnjshcd unrJer para 4.7 ofHand Book ol'Procedures (Vol.l) 2009-14:- S No Impo( Ilen) Qty. Ileconmrendcd kg/kg. 1 9,10-DinuOr。 2,3‐ Dihydro 3-Methy1 7-Oxo(3s)‐ 7H― Py●do[1,2,3 dcl‐ 1,4‐Bcllzoxazine‐ 6‐CarboxメたAdd (LVF 40) 08571 つ ¨ Hexametlryl Disiloxale (HMDSO) 050 Dircctoratc Ccncra1 0f Forcign Tradc, Dcparllllcnt of Commcrcc、 (Shrl M V Singh,FTDO) Udyog Bha、va11,Ncw DcHli lRkr"a,a/*n tBarnali Kha'ig'ilr Under Secretary to dre Govemment of India Phone:23071162
q F. No.l50l l/l7212015-PI (Nornls) Gover'nnrent ofIndia Mi11istr] of Chemical & Fenilizers DeparlDrenl of Pharmaceuticals Udyog Bhawan- New Delhi, thebg October.2015 Of'fice Mcnrorandunr
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case
of M/s Srini Pharnm Ltd. The undersigned is directed to rcfer to DGFT tl.O.No. 0l/82/50/t512lAM-15/DES- i/1405 daled the llloi/15 vide which application from M/s. Srini Plrarrra Ltd rvas scnr ro this Departnrent lbr fixation of norms under para: 4.7 for the expofl of Z-Valac],rlovir. 'lhis depart ent has examined the tDatter and the fbllowiDg no|nrs are lirrnished utder para 4.7 ol' Hand Book ofProcedlres (Vol.l) 2009-l4r- S. No. Import lteln 1 CBZ-L-Valine (Carbobenzyloxy-L-valine) 0858 つ N,N-Dicyclohexyl Carbodiimiide ()811 , 1-DimethylaDiro Pypridine 4. Acyclovir 0592 5. Dimethyl Sulfoxide t6 t?tr,a,olE1^ (Barnali Khastgir) Under Secretary to the Govemment of lndia Phone:23071162 Directorate Ge[eral of Foreign Trade, Department of Commerce, (Shri M.V. Singh, FTDO), Udyog Bhawan, New Delhi
?tv9^1-( il[∬|‖lifilll∬1瑾: g,だ° Depalllllent of PIlarmaceuticals tldyog Bhawar- New Delhi. rhc Augrsr.l0l-l o1I!E--14!!rq! lrdq]] Sulrject:- Fixation of norns u,rder para 4.? of Hand Book of Procedures (Vol.l) 2009-11 Case of [44 Aurot]i,).lo Pharna Lld. The LindeNigred is direcred io refer to DGFT U.ONo.0l/82/50/i86/AN1-15/Dlis-i/2i?.lnled rhe li/05/l4,r'idc which applicati( tiour M/s. Aurcbindo Phannr t-td was s€nl to this Depannrcnt |or li,Iion ol nomrs under para: 4.7 for lhe c\po( olNetirnpitre (Nevirxpinc Anhydrous). This depa(nrent has r\alrired rhc nratier rrdihcfollowingrronnsarelirridredunderpam4.7ofHarrdBookol Procedurcs(Voll)200Il4 S No lmpo llenr Qty. Recomorendcd k!./kg. | 2-Chloro-3-alnino'lrnethyl pytidire (CA[4P) 0750 つ l-chloro nicorinic nci.l 0902 0 100 | Syclo hexane o8,s 5 lyclo propyla ine 05' 6 Dielhylene glycol dimelhyl ether 2518 ■1` 7 7121 ヌ 8 、 0,68 9 VethvleDe Chloride 1222 SteamlThemralCoal This issues with the approval of Director (Cost). (Raj KumaD Under Se€rctary to tle Cove nrentoflndia Pl-Nonns DircctoEte General of Fore ign Trade. D€partment of Conrmerce, (Shri M.V. Sinsh, FTDO), UdyoS Bhawan. New Delhi そ [1)
SI,゛む (| 一 F. No.350 I i/205/201 5_pl (N-orn*) Covernnient oflndia lVlinistry of Chenricals & Feft ilize[s DepartmeDt oI phar maceuli.als Udyog Bhawan.New Dellri. DareC the /s Seple ber, 20lj O&ec_laeugl3ldlr! S bject: - Fixation ofno.r,. rnd"r pr.4.7-iH^rd Boik ofprocedures 1Vol.l) 2009-l.l Case of M/s Hetero Labs Ltd. The undersig.ed is dirccred to rerer ro DGFT u.o.No. 01/8?r50ll5liiANf-r5/DEs- i/1409 ddled the I l/01/15 vide which applicarion fi.oln l4_/s. Hetero Labs Lid was sent to ttrts i^1p:].lll".il t:: t,*,,:,rr ofnorms^undel para: 4.7 for rhe exporr ollrbesartan. Ihis depannrent tras exaulned the ma er lnd rhe followirg norms are furnished under para :1.7 of Hand Book of Plocedules (Voi.l) 2009- l4:- S NO hnpolt ltenl Qty. Reconnended kg/l-e. 1 2n‐ btl●1‐ 1,3‐din7,Opilo(4,4)non l‐ cn 4‐onc HCL 080 ， 一 N‐(TriphCtyhllc■yl)5‐ 14‐ brontOmculy卜b"hCnyl― 2‐yl)tCtaz01e 92% 210 Ioluene 070 4 MetliyleDe Chloride 405 “ 鮨凛晰メ Ullder Sccrctary to dlc C:Q]][」nI:聞篇 : Phone123071162 DilectOrate Ccncla1 0f Fol,ign Tladc, Dcpalunent Of Collnmercc. (Shn M V Sulgh,FTDO) Udyog B1lawan,Ncw Dclhi
TIe undersigned is directed to refer to DGFT UONo.0l/82/50/15:7/AM-1s/DES- l/1401 dated (he I l/03/15 'ide which applicatioD fiom M/s. Suvel Lite Sciences Ltd was sent to lhis Depanment tbr tixation of noflns undel para: 4.7 ibr the expofl of Methyl-2-(2- Chloromethylphenyt)-3-Methoxy-2-Acrylate. This departmeit has examined the nlatter and the following norms are lumished under para 4.7 ol Hand Book ol Procedurcs (Vol.l) 2009- d' .," \V// ," F. No.i50ll/198/:015-PI {Nornrst / ." Goventnten( of lndia \ /' Ministry ol ('henricals & FerlilizeLs 11 or.'/ Depaltnenl ol Phatttraceuticals / '' Udyog Bhawau,New Delhi. Dated the n Septe ber. 20li Ottlce Memomndunt S bjecl: - Fixation of norms urder pam 4.7 ofHand Book ofProcedures (Vol l) 2009-14 C.rse of M/s Suven [.it'e Sciences Ltd. l4:- (K(-,)v' (Barnali Khastgir) Under Secletary to the Govemment oflrdia Phone:23071162 Directorate General of Foreign Trade, Department of Conlmerce, (Shri M.V. Singh, FIDO), S. No. Import Itenl Qty. Recommerded kg/kg. 1 j-lsochronranonc 0957 ＾ Ｚ )-xylene l.0l ヽ Ｄ Sodium Methoxide 0416 4 fhionvl Chloride |.24 ● Ｊ Methanol ● リ つ 一
Case No■18119782‐ ALC42014 HQ File PaⅢ Nane:MYLAN Meet No′ Date 7′ 82_ LABOヽへTORIES LIMITED ALC4′2015 24072015 RLA IIに しic No′ Date o91oo52887 Defer Daie:30092015 gメ11 Slatus:Case Deferred Status:Crs! Deferrcd し :0′82050Ю 1506′AMIS′ o924′ 040′Olll eSパM,′ OS 06 2012 ,o P""lli9, : The Commitree in Iighr ofcommenr ofD/o pharmaceuricals forwarded vide '- O.tr4.No i 50 t I / I s7l10 I 5 -pt(Norms.) dated 24th July, 2015 decided to call for following infomration fron1 the firm:- a) Cornplete technical details as per Appendix_33 showing % yield on molar basis for each step ofmanufacturing process b) Past production vis-a-vis Actual comsumption ofall the imponed inplts duly ceflified b) Central excise Arrlhorilies. CrseNo.:J7l19/82, parryName:ASTRIX AI,C{/2{)I,T LABORATORIES LTD,. 17 HQ File RLA Fite :0I/81/0i0/0IiI5/AMI5/ :09/24l040i00079/AMrl/ Decision :The committee considerecl the case and fionl D/o Pharmaceuticals. 09!0052'25 DeFer 080620 Dale 30 09 201, dcFcicd case fof want ofcomDlents Meet No/Dare ALC4′ 2015 24072o15 Lic N
Case No:6/19782-ALC4/2014 Paゥ
Name:BIo_TECH OPHTHALMICS PVT et No′ Datei7′ 82‐ C4/2015 4072015 S●tusCasc llererrcd DeFer Date:300,201S Status:case Dererred DeFer Date13o o,2015 Status:case lDeFerred DeFcr Date:30092015 St tus:Cr!€ D€ferr.d HQ Fne :0!′ 82′05υ01494′AM15′ :01お2050′0143●lAM13′ DecisiOn:Thc cOmmtttcc rlonl DんC&Pc RLA Fie :0824′ 04αOoo93 Aヽ416′ Lic NO/Dateio81 ol 12710 ヽイeet No Date:7/82- ALC4″015 24072015 Lic N。′Date:0310724136 Mcet No′ Date 7/82- ALC42015 12407201s Lic NυDate:o510346353 18022013 ヽ4eet No7Datei7′ 82‐ ALC42015 24072015 Decision :The committee considered the case from D/o Pharmaceuticals 18062012 deferred the case lor want of conxlenls Case No:″ 4′82-ALC42013 HQ Fie 10!/82/050 0oo457A,И II′ Case NO=79′ 182‐ ALC4′ 2013 20 HQ File Pany Name:SABER ORCANICS GUJA AT /AMis/ 40220,3 しIMITED RLA File i03/95′ o40′ oo8 Part■ Decision :The committee considered from D/o Pharmaceuticals. case and defer.red the case 1br want ofcomrrcnls O STERICAT GUTS INCS PVT LTD 0′00420 AMI,′ idcrcd thc casc and dcfcrrcd lc casc fOr want OF cOmmcnts RしA PaⅢ Name COVALENT LABORATORIES PRIVATE LIMITED
Case No:y19782‐ ALc4/20
|′ g.ルル F. No.350l l/21212015_pt (Norms) Covernment oflndia Ministry ofChemicals & Fertilizerc Depatunent of pharmaceuticals Udyog Bhawan,New l)elhi. Dated the I t- Seprenber. 2015 Office Memorandunr Subject: - Fixation of,,o,n,, und". puiiilif Tiidiiil of procedures (Vot.l) 2009_ l4 (.asc of M/s Asrrix Labs Ltd. The uodemigned is direcled ro refer to DGFI U.O.No. 0l/g2l50/ I 525/AM_ I 5/DES, i/1413 daled the ll,r03l15 vide which application fiom M/s. Astrix l_abs l_tcl n.as sent to lhis DeparlDrent for. fixation of norms uuder para: 4.7 fot lhe export of Efavirenz (liSA). This dcpaflmellt has examiDed lhe matter ancl the followi|g Dornts arc fiuDished inuer para 4.7 ol. Hand Book ofProcedures (Vol.l) 2009-14:- 醜∫ i朧詰淵離貯 tn Tlad、 器翼ょ駿Ⅷ鷺hi UndCr SCCrctay tO the c:堤齢 Phone:23071162 S NO Import Item Qty. Recomnended kg/kg. ] 4-Chloro-2-trifluoroacetyl aniline lrydr.ochloride lydrate (E-2) uycro rropyl Acetylene 0343 Acetate Anh)drous 120 ltr]C AC10 1VIonOnydratc 0788 ctialyuroluran ス : ^_^ 242 590 286 D 1 1 0431 ●Itツlt‖ 0:]uC ヽ 051 ,4~L/1 Diυ :110L【!lanc(Lυ B) 001
Pil, W F. No.350l l/14212015-PI (Norms) Covernment oflndia Mi,lisrry of Chemicals & Fertilizer.s Depaltnlent of Pharntaceuticals Udyog Bhawan.Nerv Delhi- Dated rhc Ocrober. 2015 OlIce Menrorandunr
Subject: - Fixation oI nolurs under para 4.7 of Hand Book of I)rocedurcs (Vol.l) 2009- l4 Casc
of M/s Covaient Labs Pvt Lrd. 'l'he ndersigned is directed to ref'er to DGI] U.O.No. 0I /82/50/ I 142/A l\4,I s/DUS- 3/1280 dated fic 04/0i/15 vide which application from M/s. Covalcnt [,abs pvr Ltd was sent to this Department for fixatioD of lornrs under para: 4.7 lbr the expon of Cefprozil. Ihis depa(ment has eralrinecl the ntaftet and the lbllowing norms arc lumished rulder pam 4.7 of Hand Book ofProcedur.es (Vol.l) 2009-14:- S, NO, Impofi Item Qty. ReconlDlended kg/kg. 1 7-Amino Cephalospor.onic Acid (7-ACA) 2.22 ， 一 N,lethylene Chloride ´ い D Difiethyl Forlnan)ide 2.20 4 (IODO)-Trinle$ylsilane (TMSt) 2.i 8 ,N-Bis-(Trinrethylsilyl) acetamide 2.22 ´ ０ vated Carbon 0100 (Banali Khastgir.) Under Secretary to tl.re Government oflndia Directorate Gererar ofForeign rrade, Phone:23071l62 Department of Commerce. (Shri M.V. Singh, FTDO).
F. No.350 I I/5 l3/20 l4-PI (Norms) Govemment of India Ministry of Chemicals & Feniljzerc Departmert of Pharmaceuticals gヽ D誠∬幣う Ph驚誰織1規|: 呻 ∝鋼 面血ollltDlmtlldclpttomuttsⅣ 山 η 明 4G、 ofヽ4/s lndO P1lytO chcmicals Pvt ttd / Thc undclsi3ncd is dircctcd to:ctcrtO DGFT U o No 01/82/50/37/AM 16/DES‐ 37 情犠1認lT点‖‖ヽ T:憮‖l出胎肝響湘器魔ド fl思ぷ:耀|‖ Drug「his dcpar"ncnt has cxamincd thc luattЪ r alld thc 10HOwing nornls arc i]■ lshcd und引 Para 4 7 0fHand BoOk oFProccdulcs(VO11)2009‐ 14: 3:踏警留鷺晋遺 n Tradら (Sllri M V Shぃ,FTDO) UdyOg Bha■all,Ncw Dcllll Under Secretary tO thC C:Q]11:nI:需||! Phonc:23071162 Impo[t Iten: I 9-Nor-4-Arldrostcne-3 J TDio; 1,2 Ethanc Dith 01 ttrallydrOhrall ium BOrohydridc 1 45 053 2 65 1il kg 0 17 kyk8
M/s lndofil Industries Ltd. have submitted present application for the import of raw material against the export of Cymoxanil technical. The application have been examined and the Department recommends the following norms for the present Advance Authorization application. セ′′′ハヘ '9 Government of lndia Depanment oF Chemicals and Petrochemlcals Sublect Advance AuthoHzalon apprca‖ On from M/s indonl industles of raw material againstthe export of Cymoxan‖ technical (Advance AuthonzatiOn No 0310792122 dated 19 o2 2014) Re, UO No 01′ 83′ 50′237′AM16′ DES‐ 1‖′471 dated 7 7 2015
- ltem of Export Otv Lem of mpon Qty Cymoxanil technical l kg N‐CYANO ACETYL ETHYL UREA 98%MN 0 867 Kg This issues with the approval of competent authority. Addll'」lξ裾全員‖ 1:[| TeL No 011_23384430 デギ i詰』置員う 1,売譜 -11 一 ら望 “ る≒|て1ヽダ
ウ/ F. No.350l l/29312015-Pl (Norms) Coverument oflndia Ministry ofChemicals & Fertilizers Department of Phaniaceul icals Udyog Bharvan,Nerv Delhi. Dnred rhr ("5 Ucrober.:Utr Office Mernorandurn
Subject: - Fixation ofno rs under para 4.7 of Hand Book of procedures (Vol.l) 2009-14 C^se of M/s
Bharat Parenterals Ltd. The undeNigned is directed ro refer ro DCFT U.O.No. 0l/82/50/910/Aivt- l4/DES j/sj d ed the l2105/15 vide rvhich applicarion tron M/s_lj\a;.f, l2oaqkdal Ltd rvas se l to thiri Depo nrenl lbr fixatiol ol-rornts rnder para: 4.7 lbr the expod of Amoxycitlin nnd Clavulxnate potassiunr aor Injeclion. This depaflnrenl has exaniDcd lhe ntatter and the followirg nornls are tirrnished undcr pam 4.7of Hand Bookof Plocedurcs(Vol.l)2009-14:- Expori:tem:Amo、yci‖ hl and Ciavulanate Potassium for lnJec●o■1 28nl Nornls iecomillen(lcd Sterile Amox)/!il1ir Sodirlln and Clavulanate porassium --1.] Export ltem: Amoxycittin ana Ctavutanare potassium Tablet 62tnn (i) Amo\ycillin lrihydrare-.-585.16ms/Tabter Iii) Potassiurn Clavulanale Diluled wirh Microcrysralline Cellulose (]:ll_____--103.6m8/tabtet under secretaly tO the c:呪憮 享1ヘ Phone:23071162 Dhectorate Cenera1 0f FOrcign Tradc, Depalllnent orCOmmerce (Sh面M V Singh,FTDO). Udyog Bhawan,Ncw Delhi `|,ジ ツ/ | 」
F No 14010′ 36′2011‐ CH‐ ll Government of ndia Ministry Of Chemicals and Fert‖ zers Department of Chemicals and Pet「ochemicals
Subject: Advance Authorization application from [,Vs. KLJ Plasticize6 Ltd. for the
import of raw material against the export of KANATOL-4oo (N) Ref: U.O. No. 01/82050/71lAMl6/DESllr3 dated 16.6.2015 M/s. KLJ Plasticizers Ltd. have submitted presenl applications for the import of raw materialagainst the export of KANATOL-4oo (N) The applications have been examined and the Department recommends the following norms for the present Advanc€ Authorization applications. This issues with the approval of competent authority α ― lA K AGttRWAL) Add「Industttal Adviser Tel No 011‐ 23381430 l tem of ExpOrt Qtv Item of lmport Qtv KANATOL400(N) l kg PHTHALIC ANHYDRIDE 0 560 kg SABUTOL(MIX ALCOHOL) 0 595 kg HM‐HDPE DRUMS MADE OF HM―HDPE BLOW NG GRADE As per Dackino oolicv Dept 「 of C8PC No 14010′36′2011‐ CH‐ l dated lo.92015 |
GoverLrment oflndia Minisrry of Chemical & Feft ilize$ Deparhrrent of Pharmaceuticals Udyog Bhawan. New Delhi. rhe Ocrober- l0l5 Office Memoraudum Suhject: - Fixation of nornrs Lrnder para 4.7 of Hand Book of procedufes (Vol.l) 2009-l"l Case of NIis Mangalam Drugs & Orgauics Ltd. The undersigned is directed ro retlr ro DGFT U.O.No. O l/82/50/,1761,4M- 16/DES-l/52It doted the 08,'07ll i vide which application f'rom M/s. Mangalam Drugs & Organics Lrcl rvas scnt to dris Departnent fbr fixation of nolns uldel pala: 4.7 tbr the expoll of.l.onolbvir Disoproxil Fumarate. This department has examined the matter and the t-ollorving nor.ms are i'urni$ed under pala 4.7 ofHand Book of Pr.ocedur.es (Vol.l) 2009-14 - S NO Inrport Itent Qty. Reconlmended kg^g. 1 [(R)-9‐ (2_PhOsphOnyl Mcthoxy Plopyl)Adeninc 0769 Undcr Sccrcta,tO thc c:∫iλT!:卜:『]1粘ll Phonc:23071162 3詰胤讐蹴盟 :ド tn Tlade, (Shn M V Sulgh,FTDO), Udyog Bhawan,Ncw Dcllll 書
F. No.350l l/65/2015-Pl (Norms) Govemment oflndia Minislry of Chemicals & Feltilizers Depa{nrent of Pharmaceuticals Udyog Bhawar,Ncw Delhi. Dated the \ \ Septenrber. 20t 5 Ofllce Memorandum
Subject: - Fixalion of notms under pam 4.7 of Hand Book ol Procedures (Vol.l) 2009- 14 Case
of M/s AtheDa Drug Delivery Solution Pvt Ltd. The r.urdersigued is directed to ref'er to DGFT U.O.No.0l/82/50/884/A1vl-15/DI,.S- i/I156 dated the l9102/15 vidc which applicatioD florn lvl/s. Athena Drug I)eliver.y Solurrioll Pvl Ltcl was sent to tiris Depaltnlenl for fixation of norms Lxtdcr para: ;1.7 for tlte cxport oi' Theophylline Sr/Er Pcllets. This depaltrlent has exa il1ed dre matter and the fbllowilg nornts are furnished under para 4.7 oflland Book ofProcedures (Vol.l) 2009-14:- 陥 ぃ っ聯 (Bamali Kllastgir) Under Secretary to the Covcmment oflndia Phonc:23071162 Dlrcctoratc Ccnelal ofFoleign Trade, , Depa■ment ofCommcrcc, (Shri M V Singll,FTDO), Udyog Bhawall,Ncw Dclhi S No Inlpoft Ilenr Qty. Recommendcd kg/kg. 1 ThcophyHinc 0737
バヽ3ヒ MnЫり ::品錦:l晶署亀酬レes ダ Department of Chemicals and Petrochemica:s
Subject: Advance Authorization application from M/s. Galaxy Surfactants pvt. Ltd. for the
import of raw material against the export of Octyl Diphenyl Cyanoacrylate Advance AulhonzatiOn No 0310793796 dated l1 2 2015 Ref: DGFT0 0 No 01′ 83/50/426′ AM-16′DES‐ 3/464.dated 07 7 2015 M′s Calaxy Surfactants Pvt Ltd have submitted present app‖ cat on for the import of raw material against the export of()clyl Diphenyl Cyanoacrylate The appncatOn have been examined and the Department recommends the fo‖ cwing norrns forthe present Advance AuthonzatiOn applcat on Item of Exporl Oty Item of lmport Qty Octyl Diphenyl Cyanoacrylate l k9 l METHYL CYANOACETATE 0 3500 kg 2 2-ETHYL HEXYL ALCOHOL 0 4260 kg 3 8ENZOPHENONE 0 5250 kq 4 HDPE GRANULES As per packing policy This issues with the approval of competent authorjty. 体κ 聰 ` Addl lndustlal Adviser oi C&PC 14010′ 148′2011 FT dated 3・92015 耐 一 Ｎ 。 lhi―
S/〃卜了ヨ Government ofindia Ministry of Chemicais and Fert‖ zers Department oi Chemicals and Petrochemicals Subject Advance Authorization apptication from [/Us Vivimed Labs Ltd., for the import of raw material against the expori of goxo-9H-Thioxanthene-2- carboxylic acid ethyl ester Ref: u.O. No. 0'1/82/50/1 16/A[116/DES- t/19 dated i1.6.2015 M/s Vivimed Labs Ltd.,have submitted present apptications for the import of raw material against the export of 9-Oxo-9H-Thioxanthene-2- carboxylic acid ethyl ester The application have been examined and the Department recommends the lollowing norms for the present Advance Authorization applications. Ad“橋盤1群:y Tel. No.011-2338 1430 ζ3 `i「 (。 9‐Oxo‐9H_Thioxanthene_2- carboxylic acid ethyl ester
- Thiosalicylic Acid 1 215 kg Z. 4-bromo benzoic acid
- Thionylchioride
- Toluene | Dept1 0f c&Pc No '14010t138t2011-cH.]l| dated .t.9.2015
Government of lndra マス′｀4/ lvlinistry of Chemicals and Fertilizers sublect Advance AulhOHzalon ap口icatOn from M/s VVimed Labs againstlne export of ReversacoI Pennine Creen (Advance AuthoHza“on No 0010061222 daled 13 11 2014) Rel UO No 01′ 82′50/532メnl167DESJ‖′303.dated 2 7 2015 M′s ViVimed Labs Lld,have submitled present app catons for the export or ReversacoI Pennine Creen Ltd., for the import of raw impod of raw malerial againsl the The application have been examined and the Department recommends the following norms for the prcsent Advance Authorization applications. Tel No 011-23381430 shn Mahender Vik「am Singh FTDO rDES‐ ‖)0′o DGFT Udvoo Bhawan New Delhi-11 Dept OfC&PC u o No 14010′ 138/2011‐CH―‖dated 、く92015 爾百ヽ malenal Item of exoort Qtv Item of impon Qty Reversacol Pennine Green l k9 1. 4- Trifluoro methyl Benzoic Acid 1 520 kg 2. Methane sulphonic acid 6 170 kg 3. Dimethyl Succinate 3 176 kg l.- Nllethl Maqneslum chio de (3[I in THF) 1 070 kq 5. 4-Fluoro4-lrelhoxyBenzophenonq 0 617 kg ¨ ¨ 0 320 ko 7 0MS C 15 0 882 kq 8 EDC HCυ l‐ (3-01methyI Am no P「opy)‐ 3 Ethvl Cabodlm de HCL 0 294 kg 9 Telra Hydro Furan(THF) 7 900 kg 40 Methano う0 670 kq 11. Toluene 22 300 kg 12. Hexane 23 200 kg 薇鼈 ゞ
Government of lndia S/メ/1 多 / Ministry ot Chemicals and Fertilizers Department ot Chemicals and Pet.ochemicals 一 、 ヽ ― ′ ■ ¨ ■ ・ 輿 Sublect Advance Autho12a10n applcaJOn 6●mM/s V“ imed Labs againstthe export of Reversa●ol Humber Blue (Advance Autholzation No 0919059156 daled 4 2 2014) (Advance Authonzat,On No 0910061154 dated 30 10 2014) Rer UO N● 01′82/50/1344′AM15′DES‐ 1‖ ,dated 5 3 2015 M/s ⅥMmed Labs ttd have submitled present applcations for the export o′ Reversaα Э Humber B:ue Ltd.for the imp。咸Of raw matela ,イ:ヽ 11_ヽ impon of raw material against the The applic€tion have been examined and the Department recommends the tollowing norms for the present Advance Authorization applications. This issLles with the approval of competeni authority. Item of export Oty liem of impod Qty Reversacol Humber Elue ` k9
- 4.4-Dimethvl Benzo ohenone 1 00 k。
- oimethyl Succinate 2386 k9
- 4,4-0imethoxy Ben2o phenone 1200 k0 4 Tetra HydiO Fu「an(THF) 4 40 kg
- Tt.4SA (Tririethyl Silyl Aceielene) 0 717 kQ 6 Sira ox 1 200 ko 7 DMSC15 0 817 kq 8 EDC HCL71‐ (3-Dimethy Amino PrOpプ)‐3 Ethy Caboolm de HcL 0 317 kg
- Acelonitrile 5 600 kq 10 ヽ′ethanol 14 00 kq 11 Toluene 3200k。 12 Hexane 1900k0 網JI'話 `掲 1鵬:P Tel No 011_23381430 m Deptt of c&Pc No 14010′ 138/2011‐ CH‐ l dated , 72015
F. No.350l I/2512015-PI (Norms) Govemment of India Ministry ofChemicals & Fertilizerc Depar imeDt of Pharnuceuticals 9/. ^to <f-+ Udyog Bharvan.Nerv Delhi. Drred the ( \ Oclobcr. l0l5 . Olfice Memorandunr
Subject: - Fixation oI nor.uts under para 4.7 of Hand Book ol procedures (Vol.l) 2009-14 Case
of M/s Mylau Labs Ltd. The underuigned is dirccred ro reEr to DGFT U.O.No. 0 t /82/50/l 5jj/AM_ t5/DES-l/46 dated thc 12105/15 vide lvhich application fiom M/s. Mylan Labs Ltd was senl lo rhis Departlnent fbr fixatiorl of norDrs under para: 4.7 for the export of Liraglutitlc. This departnrent has exiinrired the matter and it is requested that DGF1- may call pail ploduction vis-d-vis Actual consunrption of all imported iupuls duly certified h, Cenlral Excise Aulltorities. (Stri M.V. Singh, FTDO), \14n^r^n\a,* (Banuli Khastgir) Under Sccrctary to the Govemnlent of India Phone:21071162
^"7.o ,,/ g,n'' / Udyog Bhawan,New Delhi. Dared the c - Se$enbe+, 201 5 6,shbr _. Oflice Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of procedures (Vol.l) 2009-14 Case
of lvrs Smilax Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. lllB2lSOl947tAM-t5tDES- 3/1241 dated the 03/03/15 vide which application from M/s. Smilax Labs Ltd was senl to this Department for fixation ol'norms under para: 4.7 for the export of Lossrtan potassium. This departflent has exaftined the matter and the following norms are l'urnished under para 4.7 ol' Hand Book ofProcedures (Vol.l) 2009-14:- UndCr SCCretaly tO ulc c」滉饒 Phonc:23071162 Dircctorate General of For.eign Trade, Department of Cornmerce. (Shri M.V. Sin8h, FTDO). F. No.3501 I /178/2015-PI (Noms) Government of India Ministry of Clremicals & Fertilizers Depa(ment of Phalmaceuticals S. No. Lnport ltem 1 4-(Bromomethyl) Bipheryl-2-Carbonitrile 0.80 つ 2-Butyl-4-Chloro-5-Fomryl- I HJmidazole 0.50 D Sodium Borohydlide 0048 4 Ioluene う \cetone 119
rメ′。‐51 一 F No 35011/407/2015-PI(Norms) Government OFIndia ヽ″inistry oFChemicals&Fcn lizers Departmcnt oF Phamaceuticals Udyog Bhawan New DelhL Dated the octOber 2015 %け崚 Π面 耐 mm卸 岡ざ四 鋏 所∝ “ 『 “ α ¨ "∞ J4C6eごWs lnd― Swill Labs Ltd Thc undersigned is directed to FFe:lo DGFT U ON0 01/82/50/305′ AヽスlαDES‐ 3′561 dated 骨 |li:llllF僣 l::1)鷺:よモ [lよi∫‖』 l』ifill:tl]::l:]]T:tilli:1ltfil彗lillil S No 'lmpoft hem Qty. Recomnrended kgAg. | BetamellMsone 0885 frielhyl Ofl ho Propionare 083 Medranol Delail not given. Undcr Secretaヮtothe C」幌 :1湯!話:絆篇: Phonc:23071162 没 ;i鼎鵠 :i■1瀧■ dgn Tほd｀ (Sh市MV Sn帥,日DO), Udyog Bhawan,New Dclhi
ざ I;. No.350l l/7412015-PI (Norms) Covemmenl of India Ministry ol Chemicals & Fertilizers Department of Pharmacer.rticals ふ Udyog Bhawan.New Delhi. Dared the I I September. 20t5 Office Memorandun
Subject: - Fixation of ,orr,. ,nd.. pu* 4-iiliid-Diii of I,r occttures (Vot. t) 2009_ l4 Case
ol'M/s Biological E. Ltd. The undelsigned is dirccred to rcfer to DGFT U.O.No. 0I /82/50/935/4 l\4- t 5/DES_ 3/1107 dated the 19/01/r5 vide rvhich npprication f'o,r M/s. Biological Lr. Ltd was seDl to rhis Deparlnerl for fixation ol'r]orms under pam: 4.7 for the expon olNoscapine. This deptflnrcltl has examined rhe matter and the forlowi.g nomrs are tin nished {rnder parii 4.7 oI H..cl Boori or' Procedures (Vol.l) 2009- I 4:- Export Product ~~ NoscaPinc(BP/USP/JP)_――――――――lkg lmport RecOmmcnJgd Noscapine Crude Conteut 98.5% l.05kg/kg ine Crude: Purily 98.5% UndCr SCCrctary tO thC C」見]ri111∫簿1 Pho1lc123071 162 3:∬露曽 ]::昭離■ agn Trad. (Shri M V Shlgh,FTDO) Udyog Bhawan,Ncw Dcllli ―
７ ● ″ ９ ‘ 一 ４ ヘ ヽ １ ‐ ‐ ‐ η l. No.i50l l/618/2014-PI (Nolns) ' GoverDnent oflndia Miiistry of Chemicals & Fertilizers Depaltment of Pharnmceuticals , Udyog Bhawan.Ne* Delhi. Dated the Ot Ocrober.20l5 Oflice Memorandunr
Subject: - Fixation of noms under pa&r 4.7 ofHand Book ol procedures (Vol.l) 2009-14 Case
of M/s Vivimcd Labs Ltd. 'lhe undersigned is directed to rcfer ro DGFT U.O.No.0l/82/50/955/AN,,I-Ij/DIr.S, l/1217 dated thc 0l/01/15 vide which application fronr Nt/s. Vivirled Labs Ltd was senr to rhis Departnlenl lbr fixatiou ofnor.nrs under para: 4.7 for the export o1"l'riclostn or.l.riclosan USp q VIV-20. lhis dcpar.rmellt has exanrinetl the matter ancl it is rcquested thal DGF.I nray call Past production vis-i-vis Actual consumplion of all imported inputs dnly ceftifiecl by Centml Excise Authorities. \nd\ u^r^,',lt i^ I Bi n.l,i KIt:r5l.It) Under Sccretar) to the Gover-rrmcnt ol lnrlia Phone:ll07l I62 Directorate Ceneral of Foreign Trade. Department of Conurel ce, (Shri M.V. Singh, FTDO). Udyog Bhawan. New Delhi
!/rro /Y Gove「nment ofind a Dep』1:P∬£脚潔 S』『ξlli:itds Advance AuthoHza‖ on app ca‖ On from M′S NewA‖ ance Dye‐Chem Pvt Ltd.for the import of raw material againstthe export of EDTA TRISODIUM TRIHYDRATE ITR!SODlUM EDTA TRIHYDRATE) / 折 ) ″ ) Subject: (Advance Authorizatio n No.O31O7 g3|g1/dated 1 1.02'20'1 5) Ref: U.O. No. 01/82lO5O/488/ AM- 1O/DES-lll/465 dated 07 07 2015 M/s. New Allance Dye-Chem Pvt. Ltd. have submitted present application for the import of raw material against the export of EDTA TRISODIUM TRIHYDMTE CrRISoDIUM EDTA TRIHYDRATE). The application has been examined and the Department recommends the following norms for the present Advance Authorization application '1. ltem of Export Qty Item of lmport Qtv EDTA TRISODIUM TRIHYDRATE (TRISODIUM EDTA TRIHYDRATE) l kg l ETHYLENE DIAMINE TETRA ACETIC AC:D(EDA) 0 787 k9 蟻 (AK ACARヽ″AL) Addl lndustrial Adviser shn Mahender Vikram S noh FTDO rDESJl)0/o DGFT Udvoo Bhawan New Dehi-11 Deptt of C&PC U O No 14010′ '3′ 2012-CH l dated(A92015
F. No.350l I/t05/20 l5-pt (Norms) Government oflndia Ministry of Chemicals & Fertilizers Dcpartment of Pharmaceuticals UdyOg Bhawan,oew Delhi, Datcd the octObcr,2015 SubJect:_FixationOfnOrmsunderpalll:;11「::::::;::iofProccdurcs(vOll)2009_14 Casc of M/slnchcm Labs Pvt ttd Thc undcsigncd is dirccted tO refcr tO DGFT U O NO o1/82/5α 1045/AM‐ 15′ DES― 1‖拙11冨椰i島瘍螺灘憮IP[驚i榊湯 i峰 Hand B00k Of PrOccdurcs(V011)2009‐ 14: 3:冨躍嶋:i躙離駐 dgn Tradら (Shtt M V Singh,FTDO), Udyog Bhawan New Delhi Undcr sccrcta,tO thc c:幌i器]nI:31:: Phonc:23071162 ゆ ´ S No Import Item Qty. Recommended kg/k[ | Aminoacetonitrile Hcl 119 ＾ Ｚ Nitromethane Not shown in the process or reaction. Hence nol rccommended. ● Ｄ Aluminium Ch10Hdc 1717 4 Phenol ＾ ２ 5 4(4‐hydrOv Phcnメ)_2 ButanOnc 070
G\d"//' F. No.350l U87l201 5-PI (Noms) qb-" Co*.rn*r of tnala -t *t' ./ Mini5try ot Chemicals & Fertilizers Sl / Departncnt of Pharmaceuticals Udyog Bhawan.New Dellri. Dated the fJ September. 2015 Ol'fice Memorandun Subjectr - Fixation ofnorms ulder para 4.7 ofHard Book ofProced res (Vol.l) 2009-14 Case of M/s Srini Pharna Ltd. The undersigned is directed to refer to DGFT U.O.No. O I /82/50/913/AM- l 5/DES- 3/1106 dated the l9l01/15 vide which application from M/s. Sziyri ?h".r." Ltd rvas sent ro this Deparlment fol fixation of nornrs under para: 4.7 for the export of Ramipril. l'his depaftment has exaurined the uratter and the following norms ale furnished uDder paril 4.7 of Hand Book ofProcedures (Vol.l) 2009-14:- S. No. Import Itell] Qty. Recornmended kg/kg. i+)-Cis-endo-2-aza bicycle [3.3.0] octane-3- ra-rlboxylic acid benzyl ester hcl 1976 つ 一 !.1-[( I S)-ethoxycalbonyl-3-phenylpropyl]-L-alanine 0.98 l,l'Carbonyldiinidazole 0911 Grv, ', * . l (Barnali KhasrgiD Under Secrelary to the Governmert of lndia Phone:2i071 I62 Directomte General of Foreign Trade, Depadment of Corrunerce, (Slri M.V. Singh, FTDO),
F. No.i50l l/188/201 5-PI (Norms) Cor ernnrelt oflndia Mirlistry ol Chemicnls & Fertilizers Departnrcnt of Phumlaceuticals tjdyog Bhawan.Ne! Delhi. f)ated rhe Augtst. l0l5 Oflice Mentor.aldunt
Subject: - Fixation of norms under para J.7 ol' l-lan(l Book of Procedures (Vol.l) 2{)09- ll Crsc
ul'M s M1 larr Llbs l.td The undersigned is directed to retlr to lX;1.'f ll.O.No. 0l/82/50/95l/AM- t 5/DF]S- 3/125i dated the 0-'l/0:l/15 r.iclc which applicarion lionr M/s. Mylan Labs Ltd was scnl lo rhis Dcpar'lmcnt lbr fixation ol Dornrs rurdcr para: 4.7 tin. lhc e\port of Dolutegravir Sodium. This Depa nrenl has exanrined the nlalter and t_ollowing obserr ations have been nrade:- (a) As per the I)e tlission givcn by Drug ( orltrol AdmiDistration in lbrm 29. the lcst l,icense is lirl the purpose ol'E\alninati(n. Tcst or Analysis. and shall not be used for comniercial purpose. and ib) ' re ralue acldition in Indiln runenc! is I-1 .196% (< I5%) oul). 2. ln view olaho!c lhe tinn rine\ nol lultill rhc requirer]rent ofAdvace Aurhor.izrLliorr. i. Nomrs Comntittee rrral take a linal view. ,=/L- Barnali Kliasrgir) Linder Secretary to the Govenrnrent of India Phone:23071162 Directorale Ceneral of Foreign Trade. Departmeut of Conmeite. (Shri M.V. Singh. FTDO). Udyog Bhawan. New Delhi r-*
F. No.i50l l/139/2015-Pl (Norurs) Covem enlofIndia Ministry ofChemicals & Fel1ilizerc ' Depanorertt of Pharmacert ica ls . ) ,,,' g''' ,r" tJdyog Bharvan,Ne! Delhi. Dated the cl Oclober.l0l5 9-fiec l4cttqaulul Subiect: - Fixaiion of norms nnder para 4.7 of Hand Book of Procedures (vol.l) 1009'14 Casc of M/s Mylan Labs Ltd. 'l he u0dersigned is direcled lo refer to DCFT U.O.No 0l/82/50/949/4Nl-15/DLls-:li l2l5 daled lhe 03/01,'15 vide wlrich apPlicalion iorrl M/s. Mylan Labs Ltd was sent to this Deparlll]enl lbr Il\alion ofllorrDs under par?:4-7 for lhe expo( ol-Pnloxetine t]ydrochloride. This depa ment h s errlnrined the rnatter and the following nonns are lilnlished under pnra 4.7 of tland Book ol Procedtrres (Vol l) 2009. I4:- (Bamali Khastgir) Phone:23071 I62 Directorate Ceneral of Foreign Trade, Depanment ofCommerce, S. No. lmport l!ern Qty. Reconrmended kg/kg. 1 (-)-Trans-4R-(4-Fluorophenyl)-3S-Hydroxymethyl-N- Methyl Piperidine Ｏ ι VedBne Sulfonyl Chloride ()589 じ triethvlanrine 0.55 4 sesamol 0.55 5 Potassium Carbonatc 1.21 ′ ０ foluene 5.50 フ lsopropylAlcohol 5.90
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Ir. No.350l l/177l2015-Pl (Norms)
GovemmeDt of India
Ministry of Clrenricals & Iertilizels
DepartmeDt of Phamlaceuticals
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,,,
Udyog Bhawan.Neu Dr:lhi.
Daled the z i Septenrber.. 2015
Olflce Memorandunr
Subject: Fixation ol norms under para 4.7 of Hand Book oI proceclur.es (Vol.l) 2009- l4 (,asc
of M/s Mylau l-td. The undersigned is dirccrcd ro r.efer ro DCIr'f U.O.N-o. 0l/82/50/950,,A1vt,I 5/DES_ 3/1240 dated the 03/03/15 r'icle which epplication lrom M/s. Mylan [.kl was sent to lhis Deparlnlent lor fixalion of nolrrs uncler pitra: 4.7 lor ll)e (\port ;lClindam],cin I'almitate Hydrochloridc. This dcpa melt has exalrilled the mattel ancl lhe lollowirrs uomrs ftre furrished undcr pala 4.7 ol lland Book ofPr.ocedurcs (Vol.l) 2009- l4t- 昴¨l elal./tO llC C麒1顎謂 Phonc123071162 Department of Commerce. (Slui M.V. Singh, FTDO), S. No. Impofl ltcln Qty. Recornmeuded kg/kg. 1 Clindamycin hcl 1288 2. Acetonit le 3065 D Dimcthyl Formamidc 0175 4 lyclohexane 0394 Toluene 0648 6 AcetoDe 3504 ¨ ′ llethanol 0263
alwls Party Name:BDR Meet Nυ Datc12/82- PHARMACEUTiCALS ALC4/2015 mTERNAT1010AL 29042015 PVT LTD RI A File Lic No′ Date:0310782569 DcFer Date
Case NO:79/8′82‐
ALC4/2014 HQ Filc Status: Approved :01/827050Ю0743/AMiS/103,4/040/00040AM 15/22052014 Decision::The committee decided tO ra●fy the nOrms based On the recOmmenda10n of 61A Department Of Pharmaceu●cals vide O M No35011/0フ /2015‐P(No「ms)dt 20 6 2015 as pe「 detail given below or applied by the nrm whicheverisless:‐ 01、 Qty cOnstinlethate S6dium for i●eCtiOn BP I m‖1100 lnternat Ona!units pe「 vial Vial up to 10ml Colistimethare Sodirm foi injection BP 96.65mg
′ Govemment of lndia ^｀ 多 り 'ゝ ''')')/ノ ″ Subject: Advance Authorization application from M/s. raw-materials against the export of Saccharin Kusuma Pharma. Ltd for the impod of Powder (Pure /AR) (Dental Grade) Ret uO No 01′82/050/783/AM‐ 15′DES‐3/dated 19 9 2014 M/s Kusuma Phanlla Ltd have subm tted present app“ ca‖ on for the impOrt of raw mateHai againstthe export Of Sacchann P¨ 潤er(Pure′ AR)(Dental Grade) nomsPiξ潔露‖設恩鳳認辮a::1』‖ :fe"rment"∞ mmen“ le倒厠"
- Ilem of Expod Qty Item of lmport 聖 Saccharin Powder (Pure /AR) (Dental Grade) l kg Sodium Saccharin 1 38 kg 件糀 r Addl industr al Adviser TeL No 011-23381430 Deptt. of c&pc u.o. No. tloro,e,zoog-HllGGa-lis
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f.No.l50l1/17412015-Pl(Norms) t
Govertnrent of India
Ministry of Chenical & Fer.tilizer.s
Department of Phannaceulicals
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(Shri M.V. Singh, FTDO1.
Udyog Bhawan. New Delhi
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Imporl Itenl
l, 1,3,3-Tetranrcrhylguaridinq
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Qty. Reconrmended kg/kg.
382
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一
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Udyog Ilha$arr.Nc\ Dclhi- Dated fic 2 ''l ScPtcnrbcr'. 201 5 Olllce Menlomlrdunl Subiect:-Fixat,onofnot'msrttrclcrpata4?nfHandllookolProceclures(Vol'l)2009-l4Case of M/s Lake Chenlicals Pvt Ltd. 1he rrndersigned is dirccted to reler to DGI'T U.O No' 0l/82/50/547/AM l5/l)lls i/59 daled the l4105/15;ide rvhich application lrorr M/s. Lake CheDicals Pvt Ltd wa:i seot to this Departmert fbt fixation of t1o1nls under para: 4.7 1br tlle export 01 8-Chloro-6-(2- Fluorophenyl)-l-Mcthyl-3l,4-Dihydro-3H-Imitlazo[1,5-Al [1,4] Benzodiazcpinc' this departnrent has exanrinetl the rlratter and the follolving norllls arc t'ulnished under piira 4'7 of Hand Book olProcedurcs ((rl.l) 2009-14:- F. No.350l 124912015-Pl (Norms) Covemment oflndia Ministry ofChenlicals & Feltilizers Departfi ent ol Phamlaceuticals gt ,lo-. S. No. lmport ltem Qty. Recomnended kg/kg. 1 2-Aminomethy-7-Chloro-2,3-Dihydro-5(2- Flurophenyl)l H- 1,4-Berzodiazepine Dimaleate 2.52 ， ¨ Iriethyl Ortho Acetate 0.90 (Barnali Khastgii) Under Secretary to ihe Govemment of lndia Phone:23071162 Directorate General of loreign Trade,
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F. No.350 I l/604/2014-PI (Norrnst q/'
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Covernmeltl o[ Ind la
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Mrrrisrly olChemicals& Fertilizers 9 t'o
Department of Pharrnaceuticals
LJdyog Bhawan.New Delhi,
Dated the
Octobcr.20l5
Olllce Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case
of M/s Almelo P,1 Lrd. The undersigned is directed ro refer to DCFT U.O.No.0t/82/50/82j/AM_l5iDES_3/0? dated the Nil vide which application from M/s. Almelo Plr Lrd was sent to this Depaftment lor fixation of norms uDder para: 4.7 for the export of Oxo-Erythronolido A-11,12-Carbamate. This department has examined the mafler and the following norms are furnished under para 4.7 ofHand Book ofProcedures (Vol.l) 2009-14:- (BamJi Khast8「) Undcr Secrctary tO the covernmcnt ofindia Phonc:23071162 Directorate Ceneral of Foreign Trade, Deparhent ofCommerce, (Shri M.V. Singhl FTDO), う 一 S No Import Item | Clarithromycin 2344 ＾ ′ 一 l. l -Carbonyldiimidazole 1917 0 l,8‐ Diazabicycl。[540]undeC‐ 7cnc 1 509 4 N-Fluorobenzcnesulfonimide Nol reqLrired in the process. 5 4-Dimethyl Amino Pyridine 0786 6 Triphenyl Phosphine 1 148
<, r./o /o 2- F No350H/1o512015Tl ttOrllls) Government orindia Minist,OFChcmicals`し Fcrlilizcrs Departmcnt OFPharlnaceuticals Udyog Bhawan,Ncw Dclhi, Datcd thc octObcr.2015 SuりCCt‐ ∫協lll漱 呪 :常 』T47 oF Hand BoOk ofPЮ ∝durs ed⇒ 200ゝ “ case 鵜拙f琳1弾酬欄‖ i楡拙椰粗 1湯]卓 Halld B∞k OfProccdurcs(Voll)200%14■ Undcr Sccrcla,tO thc c::l需」 nI:111は Phonc:23071162 Directorate Ceneral of Foreign Trade, Import Item inoacetonitrile Hcl ot shown in the proces. o. ."u"tionlEi"" n 3 hluminium ch10Hde (4-hydroxy Phenyl;-Z-Butanone
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F. No.3 501 l/88/2015-PI (Norns) ' Government of India Ministry ofChemicals & Fenilizerc Deparllnent of Phamaceuticals Udyog Bhawan.New Delhi. Dated the ll September.20lS Office Memomldum
Subject: - Fixation ofnomls under para 4.7 ofHand Book of Procedures (Vol.l) 2009-14 Case
of M/s Glochem Industries Ltd. Tlre nndcrsigrred is dirccted to refer to DGFT U.O.No. 0118215019421AM- |'/DES- 3/l 105 dated the l9/01/15 vide which applicatioll from lvl/s. Glochem Lldustries Lrd was serlt to this Department for fixatiorl of nornN under para: 4.7 for the expon of Levodopu. This department has exatuired the l]atter and the followilg norms are lurDished under para 4.7 ol- Hard Book ofProcedures (Vol.l) 2009-14:- S. No. Inlport Itenl 1 iS)-2-Amino-i-(1,4-dihydroxyphenyl propanoic acid 0.90 (Bamali Khastgir) Under Secretary to the Govemne[t oflndia Phone:23071162 (Shri M.V. Singh, FTDO). 際 io cr7
% ノμヴリ多´ lJdyog Bhawan.New Delhi. Dared the r I Ocrober.. 2015 OInce Menlorandutl) Subject: - Fixation of noln," ,nd", pu,ii)?E Eoi- ofprocedures (Vol.l) 2009_14 Casc of M/s Heterc Labs Ltd. Lrndcrsigned is dirccted to retar to DC|T U.O.No.0l/g2/i0/llit/AM_1s/Dt-ts- yl29l darcd rhe 0.r/0i/15 victe which applicarion ,onr M/; i;;";; ;.'li;;; ,:li,,l""[;; Deparlment lbr fixation ol nornts under i:[f"1ffiil!lj::::Iil,'],::";Jli:i,:l';;,- 1 i:: :,;:,..Jff ,.1,:i H;,*;,ff lI lli;l j:l :91 "Llr. lrrrpon itenr tornr Foreigl Srrpplier.. (b) ( OA of rhe E\porl producl. (c) Aclual waslage incurred dLt ng the process. F. No.350l l/14412015-pt (Nomrs) Govemment of India Depanment of Pharmaceuticajs 亀く ,ぃ。 ,～っヽ 「8tヘ Undcr sccrctary tO the C:liT‖ Inill1111! Phonc123071162
V
¨ SuolCCt―「ixl101° fn::T:F_d° p:::]:::f;i::::B。。k of ProCedurCS(｀/d l1 2009-14 Casc .■.1●。Pvil td l,ilJi 3n,", '"atries Pvt Ltd Thc un“ふ gned｀Ⅲoelo f電:PT『よ緊漱♀ :鮒里留譜lЯ朧淵l d ltcd脳廠:ポ職郡出ド IコⅢ納蕊言論Hd¨螂u朧 l cxpOlt oF Calcium Or,lat, 震洲ぷΨl」ドT咄1lJ‖Ⅳ蔦鳶聴ゼ l∫鷲Ψ課朧 : 3部躍‖串帯l尋11姜品蔽lC mmg md“ 制。輛喝 ^月..´●●′V∩11ヽ2009‐ 14: 4り 1鳥糊mtjふれiPIoccdurcs(VOLり2009‐ 14■ (Barnan Khastgir) UndcI Secretary to the Gov;I:I:|」 3:;キ11: (Shri M.v. Singh, FTDO), Udyog Bhawan. New Delhi ン Pam4./o [ty. Recomrnended kg/k g 085 S No lmpOIt ltem o101にAtld Anhydrい ~~ 1
F. No.350 I 1/126/201 5-PI (Norrns) Govenmtent of lndia Ministly of Chemicals & Fertilizers Departmenl of Phar maceuticals / 。1/ Office Memorandunr
Subject: - Fixation of .'or,,,.und". pui-i-?Eiid-Eiil of procedures 1Vot.t) 2009-14 Case
of M/s ShasuD Pharma Ltd. Tlre undersigned is directed to rcfer to DGFT U.O.No. 0l/82/50/1305/AM- 15/DES_ 3112'16 dated the 04/03/15 vide which application fiom M/s. Shasu[ phama Lrd was senr ro this Departmelt for fixation of norms under para: 4.7 for the expolt of Metoprolol Tartrate Tablets.l00mg. This department has examined the matter and the following norn:s are furnished under para 4.7 of Hand Book of procedures (Vol.l) 2009-14:_ Udyog Bhawan New DelhL 麟 “ ■ccヽ 清 っぃ5 陥し療 Unda sc∝da)o山cG虞]胤]よ1岬湘] Phonci23071162 3::i器窯 ::視1離紺亀 nT腱“ ' (Shri M V Singh,FTDO), Udyog Bhawan,Ncw Dclhi Import Ilem Vtcl 102(ヽ4icrocrystallinc ccllulosc) Relevant, As per packing poliry 'fartrate Stearate 102mg 4.2mg l90.8mg 33.6nrg
Govemment of lndia Ministry ot Chemicals and Fertilizers Department of Chemicals and petrochemicals Sノ Subjecl Advance Authorization application from M/s. Hindustan polyamides & Fibres Ltd. for the import of raw material against the export of Cyclamen Aldehyde - pure Ref : U.O. No. 01 tS2tOSOt iZ4St AM1 5/DES_[U945 dated 1. 1.20.1 5 M/s. HPL Additives Ltd. have submited present application for the import of raw material against the export of Cyctamen Aldehyde _ pure The application has been examined and the Department recommends the following norms for the present Advance Authorization application. Cyclamen eEehyde -
- Cuminique AtdEhyde … aldellyde/ 35%Paladium on carbOn Catalyst This issues with ihe approval of competent authority. 諄 Addl恰蕊ξ千 ]]iilll Tel No ol12338 1430 Deptt Or c&Pc S No 1401α?Ψ "1‐ CH判lddedP 92"5 -11
F No 35011/598′ 2014‐PI(Norms) Government of nd a Min stry of chemical&Fert‖ izo「s Depanment Of Pharimaceuticals Office Memorandum 2 This issues with the apprOva1 0f DirectOr(Pha″ na industγ ) C′ Sllastil Bhawan Ne、v Delhi, Dated:March 16,2015 Subi Fixation Of norms under para 4 7 of Hand BOOk Of Procedures(、 /Olり2009_14, Application of M′s cadila Healthcare Ltd The undersigned is directed tO refer tO DGFT 01/82′ 50/00832/AM15′ DES-37836 dated the 26 11 2014 vide which II掲:襦1意燃粥LI締悧馨 UO No an applicatiOn fOr nxation Of Tablet This recommended ハンし UndersecretarytOtheGol:鷲階』‖ `::詰 il! PhOne:23385765 lmport ltem Norms recomnrended 上ち≦ L229生£コ10rQgttine sulphate usP Corn starch esium stearate Dibasic calciLtm ate dehydrate USF Bo As per packing policy 墨型M Wh"e¬葛面で liner … 鰤
qt /-la , l7?' F. No.3s0l l/6172015-pt (Norms) Govemrirent of India Ministry of Chemicals & Fertilizer.s Deparlrnent of Phamaceuticals ジ / Udyog Bhawan,New Delhi. Dated the \ \ September. 2o l 5 OtIce Mernorandum Subjcct: - Fixation of norns ,r.L puru 4.7 ol H;d Book of proceclures (Vol.l) 2009- l4 Case olM/s Sequent Sciences Ltd. 1he undersigned is direcred to refer ro DGF.I. ll.O.No. Ol /82/5011251/AM- lslDES-l/t 126 dated the 20/01/15 vide whi"h ,ppii;;; fruir-'V1.. S.qu.n, Sciences Ltd u,as- sent to this Depa(ment for_ fixation of norrn. ,rJ", po,.a: zl.7 lbr the e\porl of Clozrrsolc. ThJs deparrment has examined in" n ait", una it l, requested that DGIIf may call copy ol DML frorn tt.,. itr.rr, *itfl uppruu",l cornposition of thL, export producrs. Under sccrctary tO thc c」llλl]:Ii::IIII: Phonc123071162
% ヽ F No350H/99/2015‐PI oOrms) ψ M苗ゞ∫ ::Ⅷ原肥楓‖劇ジ Departlnent of Phafl uaceuticals Udyog Bhawal,New Dellri. Dated the | | Seprenlber. 2015 Office Memorandum
Subject: - Fixation ofnorms urder pala 4.7 of Hand Book of pr ocedurcs.(Vol.l) 2009-14 Case
of M/s RA Chem Pharma Ltd. 1he uldersigned is directed to refer to DCFT U.O.No. 0l /82/50/ 1057/AM,ls/DES- 3/1055 dated the lilO1/li vide which applicarion from M/s. RA Chem pharnla Lrd was serlr 10 tiris Depaftmert for fixation ofnorms under para: 4.7 for the expon of Ractopamine l{cl. This departrent has examined the matter and the following lornrs ire flrnished under pam 4.7 ol. Hand Book ofProcedures (Vol.l) 2009-14:- 投剛鵠騨棚籠紺セ n Trad、 (Shn M V Singh,FTDO), Udyog Bha■an,Ncw Dclhi UnderSCCrctaryithec:鰊 Phonc:23071162 1(4‐Hydroxy Phcnyl)‐ 2‐Amino E伍allol(octOpaminc 4‐Hydroxy Phenメ)_2 BlllanOne S No Impon Item 1 077 つ 091 ● ♪ vlcinanol ， ′ ０ ０ 4 Ethyl Acetate 244
くい身 F. N0.3501 l/14212015-pI (Norms) Covemment of India Ministry ofChemicals & Fenilizers Depatlmert of Pharmaceuticals ,y:I:i."ji"3*,:,:,:li: 0l.fice Menorandunr Subject: - Fixation of,rrn,r, und.l pn,n l- of Hrr,l Bool oi. procetlur.cs ( Vol.l) 2009_ l.l Cas. ol \4's ( o!alfllt Lrb. p\ r Ltd The urde.siqne(i is directerr ro refcr to DGFT tj.o.No. 0 r /82/50/ l-r,+z/A M- r ii Dt,s- I l.)SU JJteJ lh( 0+ U j trriJeulriclr,rppli\rriorrIr,,n)M. ( ov,rlenr l.rb: l,!r lt(t .r....I 11, lllls D(p:lflnrer)l lol lirarror. ot noln)s. rrldcf parr: -.1.7 rirf rf," erpo,i ,,r f."fp.nrif. fhi. l;xli,*:il llh;:l]lil:l,'[,];1;il:lil" l"ri.."',,,,',.,,',. iii,il,li,iiJ "1.,.,I, * 7 u, UndCr Secrctan to thc c:襦 Phonc:23071162 7-´ unino ccpha10sporonic Acid(7‐ ACA) S NO 160 220 1 ， ヽ ヽ つ 4 222 0 1oo 6
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ALC42014 HQ FHe Pal,Nanlc KOPRAN LIMITED RLA Fie Mcet No/Date 7′ 82- ALC42015 24072015 101′ 82′050/01199′AM15′ :03/947040′ 00545/Aヽイ||′ 09092014 Datc'0092015 200 Decision : : The Comnittee in light ofcomment (r1 D/o Pharmaceulicals lbr\aLdeCr \ ile O.NLNo.i50l l/l0l/2015-PI(Norms) daled 29'r' ltrly. 2015 decided lo call 1br fbilorving intbnnation frolll thc limr:_ a) Conplete technical details as per Apperldix-i3. b) Past production vis-iL-vis Actual col11sumption ofall the imponcd inputs dLrly certillcd b-v Central excise Authorities. Slatrs:Crse Delerred Lic No′ Date 0310788934 Defer
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4. Detailed production of export producl under reference in the year 2014_15 and
conesponding consumption ofraw-materials duly certified by CA
5. Basis of applied quantity of raw matedals including authentic printed literaruE in
sqpport ofthe quantity law material.
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ALC4/2014 HOF:le |.sta. 138 Pa"y Nanle M YしAN 卜Иtet NO′ D8te:7/82‐ LABORATORIES LIMlTED ALC42015 240,2015 Slitus:Case Defcrred Lic NげDate:0910052887 Derer RLA Fle :01/81/050/01506/AMli/ :09i24/040/00085/AM [/ 05.06.2012 Dale:30.09201j ,. Decision : lhe Conrmiltee i0 lighr ofcomment ofD/o pharmaceuricals forwarded vide ' ' () M No.j5U I li lq7/l0l 5-Pl(Nor,|ns) dated 24'r, July. 2015 decided to call lbr follorving inLmration lionr the firm:- a) Complete tcchnical derails as per Appendix-jl sho$,i g % yield ol1 rnolar basis for cach step ofnanufactu ng process b) Pasl producriorl vis-i-vis Actual consumption ofall the imported irputs duly cel.tilied b)' Celrtral excise Al(hoities.
Ir;ta 17 1- F. No.350l l/83/2015-PI (Norms) . Government oflndia Departmelrt of Pharmaceuticals Udyog Bhawan.New Dclhi. Dated the ll September, 2015 Olfice Memorandum
Subject: - Fixation of noNrs uuder pam 4.7 ol Hand Book of Procedures (Vol.l) 2009- I4 Casc
of M/s I:ytan Labs t.td. The undersigned is dilected to rcler to DGIr'l U.O.No. 0l/82/50/1065/AM ls/DES- 3/1099 dated the l5/01/15 viclc which application from M/s. Eytan Labs l,rd was sent to this DeparhDent for fixatiol of Domrs LrDdet para: 4.7 for drc exporr of (2R-Cis)-.1-a mino- I - [2- (hydrorymethyl)- l,3-oxathiolan.5-yll-2(l H)-pyrimid inone monosrlicylatc nonohydrnte. This depanment has exanlined thc matter aod the lbllowirg noIms are lirnished Lrnder para 4.7 ofHand Book ofProccdures (Vol.l) 2009-14:- OncrrrrzfX,. (Binali Khisrgu) Uider Secretary to the Govemment of lndia Phone:23071162 Dircctorate Ceneral of Foreign Trade, Departrnent of Commerce, S, NO, Import ltenl 1. 4-Arnino-2-Oxo-Pyrimidinyl-Oxathiolane-2- Carboxylic Acid-lsoplopyl-Mentyl-Cyclohexyl Ester (Cyclohexyl Ester) ´ ０ 2. Sodium Borohydride 0266 3 Dipotassium Hydrogen Phosphate 0988
S l,^ro l tr ( F No 35011/63/2015 PI(Nol■ lns) Govclnlncnt oflndia Ministry of Cherriicals & Fertilizers DePaltment of Pharmaceuticals Udyog Bhawan,New Dclhi, Dated the 'l Septenber', 2015 Otfice Mernorandum
Subject: - Fixation of norms under pala 4.7 of Hand Book ol Plocedutcs (Vol.l)
2009- 14 Case ol'M/s Titan Labs Pvt Ltd. The r-rndersigned is directed to ref'er to DGFI' U O.No. 0l/82/50/1031/AM- l5/DES-3/l I l0 dated thc l9l01/15 vide which application from M/s. f itarr Labs Pvt Ltd was sent to this Depa(ment fol fixation of norn.rs ttnder pala: 4.7 1br-thc export of Dabigatran Etexilate Mesylate. This departnrent has examined the lnatter and it is requested that DGFT rnay call following technical delails from the firm viz:- (a) Copy of DML for the export product, and (b)Master - Batch formula duly certified by their Qualify-Control Incharge. G鑽静臨おま Under Secretary to the Government of India Phone:23071162
`ぃ l_、ノレ, F. No.350l l/1442015-PI (Norms) Govemment of lndia Ministry ofChemicals & Fertilizels Depaft uent of Phafmaceuticals Udyog Bhawan.Nen Delhi. Dared dre o I October.2015 Oflice Memomud!m Subiect: - Fixatior ol'lornrs urder para.l.7 ofHald Book olProceclLrres (Vol.l) 2009-14 Case of M/s lletelo l.ahs Ltd 'fhc undersigncd is directed to retel to DGFT UO.No. 0l /82/50/677lAM- I 5/DI-]S- i/1292 daled the 0tl/03/15 vide which application tionl M/s. I letero Labs Ltd was scnl to lhis Departnrent for' fixatiou ol nol'lis Lrnder para: 4.7 for the expofl of Irbesartan. This ,-lcpal1nlenl has examined the natter and tlre fbllorving uolms are fumished under para 4.7 of Hand Book of Plocedures (Vol.l) 2009- I4:- Phone:23071162 Dircctorate Ceneral of Forei$ Tnde, (Shi M.v. Singh, FTDO), S. No. luport IteDr 1 2-n-Butyl- 1,3-Diazaspiro[4,4] non-l -en-4-one Hydrochloride 0.80 , l-Bromomethyl-2-Cyano Biphenyl 0.94 l. Sodium Azide 02618 (Barnali Khastgirl
0 ^′ 。/吻8 F. No.l50l U225l2015-PI (Norms) Covennnent of India Ministry of Chemicals & Fenilizers Depadluent of Phaflnaceuticals Udyog Bhawan.New Delhi. Dared the e7 Ocrober. 20lj Oftice Mentorandum Subject: - Fixation of ,lo,nr. und.. poiiiJiif*IEi[ of procedures (Vol.t) 2009-t4 Case of M/s Salicylares & Chemicals pvr Ltd. Tllc rurder.sigrcd is dirccted ro refir ro DGFT U.O.No.01/g2150/1325/AM_1s/Dt.ls_ 3/1358 dated thc l0/03/15 vide which application fioln M/s. Salicylates & Chenricnls I),r [.td was sent io this Depa[Dent fbr fixation of norms under. parat 4.7 Ibr the export ol.sodium Salicylate. This departncnt lras cxamilcd the mater and the following norms are timishcd tunder para 4.7 ofllaud Book ofplocedures (Vol.l) 2009-t4:_ UndCr SCCH・arytOlhCGf捲|||よ1}:l報 Phollc123071162 踏器1::嘲ぷ■ dtt Tlad、 (SM M V Singh,FTDO) Qty. Reconmended kg/kg. S No I Import ltem HメrO対dC 088 0255 つ
F. No.j50l l/t43120t j_pt CNorms) Covemntent ollndia Ministry of Chemicals & Fenilizers Department of pha rmace uticals Udyog Bhauan,Ne!v Delhi, Datcd the October.20l5 Olfice Memorandum
Subject: - Fixatio,r ofnn.r. unde, paroi-iiEii B i< ol procedures (Vot.l) 2009-14 Case
of M/s Herero Drugs Lld. Thc undersigned is directed to reter to DCFT U.O.No. 0l/82/50/ 1097/At\4- I5/DES_ l/1291 dated^ihe_04/01/15 vide which applicalion from M/s. Ilerero Drugs Ltd was senl to this Department for fixation of norms under para: 4_7 for the export of iantoprazole Sodium Sesq-uihydrat€. This department has examined lhe malter and it is requested'thht DGFT may callfollo\inS rechnicalderails lrom the firm rrz.- (a) Cmplete technical detail as per Appendix-jj showing Mol.wt. of input and output prodLrcts. Requiremerrl & Recovery of solvents at each step of manulacturing process. (b) The yield in lasr step is very low. Technicaljusrification alongwirh copy ofteclmicat literature may be furnished in support oftheir yield r c ) Pasr prorlucrion \ is-a-vis Acrual consumprion of all inported inpur duly ceninea by A]__ Central Excise Authorities. Undcr Sccretary tO the Co冤]li:話::湘: Phonc:23071162 DirectOratc Ccncra1 0fForc,8n Trade, Dcpartmcnt ofcOmmcrcc, (Shn M V Singh,FTDO),
gル1要 / F. No.350 I I/t 45120t 5-pt (Norms) Coventment oflndia Departmenl of pharmaceuticals Udyog Bhawan,New Delhi, Dared the September, 2015 Office Memorandum
Subject: - Fixaiion.of no.rn. und", priilTolli.d-Gik of procedur.es (Vot.l) 2009-t4 Case
of M,s Herero Labs Lld.
The undersigned is direcred ro refer to DCFT U.O.No. 0 t /82l50/994lAM- t 5/DES_ i lJ86 dnred rhe 04/0'i/ t5 \ ide which anpticarion fi.om M,. H.;",; i ;;;;,; ;as senr ro rhis DepanrneDr tor fixarron o[ nor.s und., p ra: 4.7 for in. ;;il';i;;;;udine. This depa menr has examined the marer and ir rs *qu..,.a rr,", odri lly Jir iliilr.Jing r""r,ni"ut details fiom the firm vizi (a)COA oflmpOrl lcm from the Forcign Supplicr (b)COA of Exporl Product (c)Actual、v6tagc incturcd in thc proccss デ ． 謙朧::庶瀧貯ⅢT劇ら 資鮭漁満嶋鷹鷺‖ i Undcr sccrctaッ (O thc c:!lil湯[1}論11は Phonc:25071162
ii: 9!. /r4 F. No.350l l/195/2015-PI (Norms) Govedment of lndia Minislry of Chemicals & Fertilizers Depanment of Pharmaceuticals Udyog BhawaD.New Delhi. Dated the ,'\ Septenber. 2015 Office Memorandum
Subject: - Fixation of nornl, ,nd". p*-4-TifEiiTiil of procedures (vot.t) 2009-14 Case
of llls Hetero Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 0l /g2l50/793lAM_ |5/DES_ 311424 dated the 12103115 vide which application from lvlls. Hetero Labs Ltd was sent to this Department forfixation ofnorms uader para: 4.? for the export of Nevimpine, This department has examined the matter and it is requested that DGFT may call following technical details l'rom the firm viz:- (a) Cetificate ofAnalysis (COA) of Imported Apl from Foreign Supplier. (b) COA of Export item as per shipping bill. (c) Justification for actual wastage occurred during the process, ifany. ca』出凝紳 Under Sccrcta,tO the Covenllllcnt of lndia DircctOratc Ccncra1 0f Forcign Tradc, Dcparlmcnt oFConlnlcrcc, (Slui M V Sillgh,FTDO) UdyOg Bhawan,New Dclhi PIlonc:23071162
a I A.^^ tb Z)))Db-- t r F. No.i50l li 190/2015-PI (Norms) Govemmeit oflndia Ministry oi Chemicals & Fertilizers Depaltment of Pharmaceuticals Udyog Bhan;an.New Delhi- Dated the oS Oclober. 2015 Ot'fice Memorandunr
Subject: - Fixation of oortns under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Casc
of M/s Hetero Labs Lrd. 'l'he undersigned is directed 10 ret'er to DGFT U.O.No. 0l /82/50/794lAM- l5lDES- 3/1442 dated the l6103/15 vide wlich application from M/s. Fletero Labs Ltd rvas sent to this Department for tixalion of norms under para: 4.7 lor lhe export of Aripiprazole. This departNent has exaurinecl the Dratter and the lbllowing nomrs are llrnished undel para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S. No. In'lpo.t Item Qty. Recom0ended kg/kg. 1 7-Hydroxy-3,4-Dihydro-2(H)Quinolinone 0644 2 L4-Dibromobutanc ２ フ イ ０ \cetonitrile 2.95 4 I -(2,3-Dichlorophenyl) Piperazine Hydrochloride 0555 $e^^o^r!tu (Barnali Khastgir) Under Secretary to the Govemnrent oflndia Phon€:23071162 Directorate General of Foreign Trade. Department of Cornmerce,
叫 F No350H/203/2015‐ PI Norllls) Govcrnlnent of lndia MilllstりofChcmicals&FcrliHzers Dcpartnlcnt ofPhallllacetltcals Udyog Bhawa:,Nc、、DclhL Datcd tllc l c・ SCptcnlbc1 2015 omcc Mc:llomildtlln Sublccl_「ixation of nollnts undcr pala 4 7 0f Hand B00k Or PrOccduFs(VOlり2009 4 Csc of M/s R L Finc Chcnl lhc undcもigncd is dircctcd tO rcfcr tO DGFT U o No O1/82/50/1033 AM-15/Dl]S_ 3/1453 datcd thc 17′03/15 vidc 、vhich`lpplicatiOn f10[ll Mノs ヽ4ct10chcln R L Fine Chcn〕 、vas scnt to ti]is Dcpallmcnt 10r ixatiOn Of nornls tlndcr para:4 7 tOr thc cxpol1 0「 orphenndrinc Gtr・l“ BⅣEⅣUSP Ths dcpanmcn hるcx:R響 出13ら誌9珊:lhC銅 応面ng∞ ・■s at ftllnishcd undcr para 4 7()fliand BOok ofPrOc( S NO Impon ltem Qty. Reconrm.nded kgTkg 1 2-Methyl Berzopherone 070 つ 一 Acetone 一 Ｄ つ 一 闊c―粋 Under secrctary to the G::lttlnI::]I:は Phone:23071162 3:問i黙視篤言 tn・亀 (Shiヽl V Singh,FTDO),
Udyog Bhawan.New Delhi. Dared rhe l\ Seprember.20l5 Ar&91!t!raa!a!d!!o
Subject: - Fixation-ol no.n,. und". pr* 4- uFH"ld tsooL of procedures (Vol.l) 2009_ l4 Case
of M/s Micro Labs Ltd. _ fhe undersigoed is directed ro rel.er ro DCFT U.O.No. 0l/81./50/l I 5 l/A1.,l- l s/DES- 3/106-0 dated the lji0l/t5 vide which appticarion ri". Vl.. trl$liU,"puritd as sent to this Deparrmenl for fi\atiol of nornrs urder p".", +.i fll-im' "lport ' ,,r pr".i fo. Nifurorazide Capsules of 362 mg Conraining iOOrng Nif"*rria"_ "ihi" ',leparr,lent has examincd the matler and the lbllowins noms aie furnis'hed urd". poru q.iotltjarA goof ot. Procedures (Vol.t) 2009- l.l:- UndCr SCCrctary tO thc C:iよ 揚J卜[lili: 踏靭鵠讐硼ぷ還 dtt T劇｀ 踏翼ょ澱鶴∬撃 hi ´ 5'/くノ |いノ (り F No 35011/52/2015‐ PI oヾOrms) Govcnlnlent Of lndia Minist,OFChcmicals&Fertilizcrs Dcparlment oFPharlnaccuticals シ / ヽ/ Phonc:23071162 Imporl Item QりRccOnllllcndcd kttg
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Datcd hcご,M.2∝ 5 SuttCCt:‐ FixatiOnofnornlsundcrpf):〕:;::]:ii:1:::iorProcedurcs(V011)2009‐ 14 Casc of M/s scntiss Phamla Pvt Ltd The undersigncd is dirccted to leFcr tO DGF「 UoNO o1/82/50/1o52/AM‐ 15/DES― )n fFOin M′s Scntiss Pharllla Pvt Ltd、v6scnt to li}:l[IiI‖lillililli∫懲 1:漱|: Under secrctary tO thc c::iWInI:需11: Phonc:23071162 F. No.350l 1/1292015-pt (NorDs) Government oflndia Ministry ofChemicals & Ferrilizers Depaft mert of Phamraceuticals 廠働a。トボハ 脱露盤黒}臨:智セ n Tm“ , 器翼漱瓢露鷺温 9.No-16 SodiurD Ilydrate Inrport ltelr Qty. Reconxnonded_ 1.8475o19/vial
F No 35011/28,/2015‐ PI(Nornas) GOvcmment Orindia ヽlinistry ofChcnlicals&Fcrtilizcl s Dcpallnncnt ofPharmaceuticals ,嵯 Udyog Bhawan.Nerv Delhi. Dated the c] Ocrober. 2015 Ol'fice Menror.andunt
Subject: - !'ixaiior of n,r.,,.,r rnd", pui7TiiE*d-dii- ot.procedures (Vol.l) 2009_14 Case
of M/s Jubilant Generics Ltd. The uDdersigned is direcled ro ret-er ro DGlr.l U.O.No. 0l/g2l50/l 024/AM_ I5/DllS_.1/57 daled.thc l'v05/r5 vidc rrhich appricarion fro,, M/s..r.bilanr c.*.i". iia- *". scnr ro this l repartntcnl tor tixaljon o l- uonrrs under para: 4.7 lor the export of Simvastatin l0mg, 20mg & ,l.mg labtet. This depan.renr has exa;ned the matler arri irt;6;;;",t;;;; DGFT nrar call tbllowillg rcchnical detrils [roDr the fiflrl \ iz:_ (a) Copy of DML lbr rhe above export. (b) Copy of Master-Batch lormula cluly cerrified by etnliry_Conttol hlcharge f.or each expo( ptoduct. はCtrclall l…正躙 : Phone:23071162
Udyog Bhawan,New Delhi. Dated the o7 October- 2015 0錨cc Mcmomndum Sub」cct― Fixation or nornls undcr para 4 7 oF Hatld BoOk O「Proccdures(V011)2009 14 Casc oFヽ4/s Pcrkin Labs Ltd F No350H/22172015‐PI(NolHls) Govcmmcnt ofindia Ministry oF Chcmicals&Fe■ilizcls Dcpartment ofPharm¨ ctiticais ,リ Und∝&Cnay。・e:認鴛幣聯 Phonc:23071162 'fhe undeNigned is directed lo rcfer to DGFT U.O.No.0l/82/50/799lAM_ts,DES_ 3/1360 dated the l0/0il15 vide which application fiom M/s. per.kiD Labs Lrd was senr io ttris Departnent for fixatiotl of norms under para: 4.7 fol the expotl of 2J Dibromo-S-Benzoyl Pyrrole. This departmelt has examired the ,,atter and the following no;ms arc lumished under
para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:-
獣鵬::留鷺譜 tn Trad、 (Shi M V Singh「TDO) UdyOg Bhawan,Ncw Dcllli S No 110
′ ハ /'笙 Government of lndia
Subject: Advance Authorization application from M/s. Hindustan Polyamides & Fibres Ltd. for
the import of raw material against the export of Phenyl Ethyl Alcohol or 2-phenyt Ethyl Alcohol or Beta Phenyl Ethyl Alcohol raw material Phenyl Ethyl the following norms for Ref: UO No 01/82/050′ 1181′AM15′ DES‐ ‖νll12dated 19 1 2015 M/s HPL Additives Ltd have submitled present applcation for the import of against the export of PhenyI EthyI Aloohol o「 2‐Phenyl Ethyl AIcohol o「 Beta Alcohol The application has been examined and the Department recommends the present Advance Authorizat on application.
- ltem of Expo( Qtv Item of lmpori Qty Phenyl Ethyl Aloohol/2- Phenyl Ethyl AIcohol′ Beta PhenyI Ethy: Alcohol l kg
- Styrene 1 310 kg 2 Methano 0 120 kq
- 5% Palladium on Carbon Catalyst 0 0002 kg This jssues with the approval of competent authority 体糀 r Addl lndust百al Adviser ／ 緬 呻 ahender Vikaram s nqh FTDO (DESJV)0′ O DGFT Uc of C&PC U o No 14010′ 90′2011‐CH ldatedo 9 2015
[$uo,".l3i^ (Bamali Khastgir) Phone:23071 162 g tn, 171 F. No.350l l/184/2015-Pl (Norms) Govemment ofIndia Ministry of Chemicals & Fertilizels Department of Phatmaceuticals Udyog Bhawan,New Delhi, Dated the I I September, 201 5 Otfice Memotandum
Subject: - Fixation of nonns under para 4.7 of Hand Book of Plocedures (Vol.l)
2009- 14 Case ol M/s Malladi Drugs & Phalma Ltd. The undersigned is directed 1o refer to DGFI' U.O.No- 0l/82/50/1080/AM- l5/DES-I/1250 dated the 03/03/15 vide which application from lr,l/s. Malladi Drugs & Pharma Ltd was sent to this Department for' fixation of norms under para: 4-7 for the export of Phenylepherine Bitartrate. This depaftment has examined the matter and it is rcquested that DGFT may call following technical details from the fiur viz:- (a) Complete technical details as per Appendix-33. (b)Past production vis-a-vis actual consumption of all the impofted inputs duly certified by Centlal Excise Authorities. Department of Commelce,
9u't" IVS Government of lndia oepartment of Chemicals and Petrochemicals
Subject: Advance Authorization application from M/s. AVA Chemicals Ltd. for the import of
raw material against the export of Disodium Manganese EDTA (Manganese conleol 1 2.5% (+ I -0.5o/o) Ref: U.O. No. 01/82l050/854/AM-i 3/DES- y176 dated 23.6.201S U.O: No. 0 1/821050/57 2t AM-1 6 tDES-|t t27 S dated 1.7.201 s U.O. No. 0ll82050/63/AM-16/DES- t/125 dated 16.6.2015 M/s. AVA Chemicals Ltd. have submitted present application for the import of raw material against the export of Oisodium Manganese FDTA (Manganese content i2.S% (+/- 0.5%). The application has been examined and the Department recommends the following norms for lhe present Advance Authoization applicatjon. Thjs issues with the approval of competent authority. 剛 輌 ヾ Tel No oll_23381430 Disoai u m lrt a n g a n es-e ED (Manganese content .12.50/6 l+t-o.svd
- EDrA (EthytenE DEEine Tetra Acetic Acid) oepn. or c&ec U.. No- 14010t67t2011-Cif,a;i;a L 92015
Government of lndia Ministry of Chemicals and Fertilizec Sublect Advance AuthO市zation app cauon frOm M′ s NA Chemicals Ltd lor the impott ofrav matenal aga nstthe export of Disod um Z nc EDTA(Zinc COnlent 1 5%(+′ ‐05%) UO No O'′ 82′05012477A'4‐ 16′ DES‐ ‖ l′462 dated 7 7 2015 U O No 01′ 82′ 050′759′AM‐ 16′ DESi‖′751 dated 10 8 2015 U O No 01′ 82′ 050′761′AM‐ 16′DES‐ l‖′722 dated 4 82015 U O No 01′ 32′ 050′ 248′AM‐ 16′DES‐ ‖′393 dated 7 72015 M′s AVA Chemicals Ltd have submitted present app:ication for the import of「 aw matenal aga nStthe export of D sodium Zinc EDTA(Zinc COntent 15%(+′ 05%) The app‖ cation has been examined and the Department recommends the fo‖ owing no「ms for the present Advance Authorization app ication ance Autho「zation No 0310792384 dated 26 12 2014 1 ltem of ExpOn Qty Item ol lmport Qty EDTA DIAMMONIUM LIQUlD ASSAY MIN 40% l kg l ETHYLENE D!AMINE TETRA ACETIC ACID(EDTA) 0 410 kg ´ う nce Aulholzalon No 0310795624 dated 2′ 042014 1 にem ofEメpO蔵 Qty Item of lmport Qty DISODIUM MECNESulM EDTA CONTENT 6% (+′ ‐ 05%AS M0 l kg , ETHYLENE DIAMINE TETRA ACETIC ACID(EDTA) 0 750 kg J・」) ―´ = :tl ´ ce Authorizalon No 0310295381 dated 17 4 2014
- ltem of Export Qty Item of lmport Qty EDTA TETRA AMMONIUM L QUlD ASSAY MIN 40% l kg l ETHYLENE DIAMINE TETRA ACETIC ACID(EDTAD 0 420 kg …
No 0340792634 dated 7 1 2015
- ltem of Export Qty Item of lmport Qty EDTA TETRASODIUM l kg l ETHYLENE DIAMINE TETRA ACETIC AClD(EDTA) 0 750 kg This issues with the approVal of competent authorty 体K鰈 Addl lndustrial Adviser Sh“ Mahende「Ⅵ時am Snqh FTD0 0ES‖ D αo DCFT Udvoo BhawacNew Ddh」■ Deptl of C&PC u O No 44010′ 67′2011‐ CH‐ n datedマδ 92015
Sh“ ^‐ V ~'駄 Deptt Of c&PcUo No 14010′7872012-CH‐ ‖dated Government of India 2 92015
Subject:: Advance Authorizat on app‖ cation from M/s Esleem indust‖ es Pvt Ltd
forthe impOrt of raw matenal aga nstthe exPort of Product 80 0(N,N,N.N TETRAKIS 2-HYDROXYPROPYL ETHYLENEDIAMiNE) (Advance Authorza‖on No 1710005934 dated 18 10 2014) UO No 01′ 82/0501126/AM‐ 16/DES‐ ‖ |′62 dated 12 6 2015 9^/" . / 3? 仏k薇扁渕,「 Add「 ndustlal Adv ser Tel No 011_23381430 Ref i,l/s. Esteem lndustries Pvt. Ltd. have submitted present application for the import of Iaw material against the export of producGSo-e (N,N,N,N TETMKIS 2_ HYDROXYPROPYL ETHYLENEDIAMINE) _ The application has been examined and the Department recommends the following norms for the present Advance Authorization applicaiion. /
- ltem of Export Product‐ 80‐Q (NIN,N,N TETRAKIS 2‐ HYDROXYPROPYL ETHYLENEDIAMIN
- Ethylene Diamine
- Propylene Oxide Qty Item of Impod Qty l kg 0 2075 kg 0 8075 kg
タノ ^/● /りも F No 35011′ 113′2015-PI(Norms) Government oflndia Ministry of Chemical&Fert‖ izers Department of Pharlnaceuticals ofrce MemOrandum Shast百Bhawan,New Delhi, Datedi September ll.2045 Sub: Fixation of norms under pata 47 ol Hand Book of Procedures (Vol l) 2009-14, Application of lv/s Reckitt Benckiser Healthcare lndia Ltd. The undersigned is directed to refer to DGFT U.O No. O1/82/50/1149iAM 1s/DES- 3/'1258 dated the 03.032015 vide which an application from M/s Reckitt Benckiser Healthcare lndia Ltd. was forwarded to this Department for fixation of norms for the export of Mucinex Fast-Max DM Liquid Max (OTC product). This department has examined the matter and the following norms are furnished under pa? 4.7 ot Hand Book of Procedures (Vol.l) 2009-14 . lmportitem 類o坐n Cum【ypZ曽)■L上望,USP,リ Proptt GO 1019]Ψ 'N[ _ Maglasweet 110-. Oranqe Wonf Flavour 9り,■γ,erry[いvaOur ____ FD&C Red#40 sorpnp 5o,!p■(Zp4)lsP_ _ ___ Propylene Glycol USP G ycenn USP Anhvdrous C蔵nc Acd uSP Quanlty recommended (per bOttle of 180 mり _ _ p15Qgm_ __ _ _ 92819甲 _ l Qtt g吐 _ Q14259咀 Q誓4Q9■ ⊇pp叩 21p75gQ 42′,9m 蟹iβQp g" 0 252 om Sodrum Benzoate NF 0 313 om ＾ Ｚ Sucralose NF 0 284 qlη ＾ ０ EDTA D sodium uSP 00710m 14 Venus 24 MM(P aSIC C Osure) Relevant, As per packing policy ５ 一 ６ Square Mρい′ash O/C Blue HT (PlaSuc CЮsures) _― ―― Mucinex4P Mu‖ ipage DM Aduk(Paper Labd立― ― ―― ― ― ― ―一 2 Directorate General of Foreign T「ade, Department of Commerce. (Shtt M V S ngh,FTDO) Udyo9 Bhawan New Delhi 幽 "。 ´リハ (Barnali Khastgi0 Under Secretary to the Government of lndia Phone 23385765
F, No.-1501 l/l 86/201 5-PI (Nonr.rs) Government oflnd io 9 Ministry of Cheniicals & Fertilizers Department of Pharnaceuticals Udyog Bhawan,Nerv Delhi, Dated the I t September', 2015 Ofllce Memorandum
Subject: - Fixation ol nolms undel para 4.7 of l-land Book of PlocedLrres (Vol.l)
2009- 14 Case of M/s Ptous Labs Pvt Lttl. Tl.re undelsigled is directed to rcibr to D(iFT U.O.No. 0l/82/50/l 33ilAM- l5/DES-I/llll dated the 05/03/15 vide which application from M/s. Plous Labs Pvt Ltd was scnt to this Depaftmerlt for fixation of norns undel pa|a: 4.7 for: the exporl of 2-Phenyl-3,3-bis(4-hydroxy phenyl) phthalimide (PI'P-Bl'). As per the End-use declalation, the firn has desclibed tl.re expolt iteur as 'Fire Chenicals'. DoP is therefol not concerned. DGFI' may reter the case to Deparlurer.rt of C & PC. 国枷´賊 (BamJi Юlastgr) Under Secretary to the Governlnent oflndia DiКctOlate General ofFOleign Trade, Department ofCOmmerce, (Shri M V Sin山,HDO), Udyog Bhawan,New Delhi Phone123071162
F. No.350I l/l3212015-P[ (Norms) Government oflndia Ministly of Chemicals & Fertilizers Department of Pharmaceuticals Udyog llharvan.Ne* Delhr. Dated the )'? September. 201 5 Olilce Memorandunl SLlbjectr - Fixatior olnoflt)s under pata 4.7 ofHand Book of Procedures (Vol.l) 2009-14 Case of M/s Neuland Labs Ltd. -lhe uDdelsignecl is directed to rcler to DGF] U.O.No. 0l/82/50D01/AN/-l5/DtlS- i/I297 dated the 05/03/15 vide which applicatior liorr M/s. Neuland Labs Lkl was scnl 1(r lhis Depattrnent tbr tl\ation ol nornls under pata: 4.7 ibr the exporl ol Ramipril. This departnrent has exan ned the maltcr and the follorving r'torms a.e fumished uncler para 4.7 ofHancl Book ol' Procedurcs (Vol.l) 2009- I 4:- S. No. lnpo ltcln Qty. Recommended ksrkq. l. (l S,3S,5S)-2-Aabicyclo (3.3.0) Octane-3- Carboxylic Acid Benzyl Ester Hcl 0.83 つ Vethvlcne Chloride 2.50 つ ECPP Alaninc 0.98 4 l-Hydroxy Benzotriazole 0.53 5. Dicyclohexyl Carbodiruide 0858 6. Di-isopropyl Ether 7 5%Palladium on Carbon 00254 F(jr.vo."W (Bamali Khastgir) Under Secretary to the Government of lndia Phone:2307t162 Department of ComrDerce, (Shri M.V. Singh, FTDO).
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,パタ。 /9ノ F. No.350l l/219/2015-Pt (Noms) Government of India Ministry of Chemicals & Fenilizers Departnerlt of Pharmaceuticals UdYog Bhawan.Nerv Delhi. Dated the il SepteDrbcr.2015 Oilice Menrorandum Subj ect: - Fixation o I nornls under Pam 4.7 of Hand Book of Pr ocedures (Vol l) 2009- l4 Casc of M/s Ast x Labs Ltd. 1'he undersigned is directed to refer to DGFT U.O.No' 01/82/50/910/AM- 1 5'/DES- l/1126 dated lhe 05103/15 vide which application from M/s. Aslrix Labs Ltd was senl to this Department for fixation of norms under paral 4.7 for lhc expofl ol Lamivudine (Cyclohe{ l Esicr Route). This dcpanrnelt has exanined the matter and the following norms a|e litnished under prra 4.7 ofHarld Book ofProcedurcs (Vol.l) 2009-14:- il-/a. -l lIl!u''r r ! (BarnaliKhastIir) Under Secretary to the Governnrent of India Phone:23071162 Department of Cornmerce, S. No. lmpon Ilem Qty. Reconmended kg/kg. 1 Cyclohexyl Ester 2.19 つ Sodiuru Borohldride 0.48 D Dipotassiumhydlo gen Phosphate 198411 4 Salicylic Acid 0832 5. Methanol 0167 6. Ioluene 0200 7 Iriethvlamine 0575 8. soprpyl Alcohol 1427
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Subject: Advance Autho.ization application from M/s. Nagarjuna Agrichem Ltd' for the impod of
raw material against the export of Tricyclazole Technical Solid' Refi*-+-+ U o. No. O 1i83l50/00912/ALl-15/DES-|V/12'19 dated 3'3 2015 Sw' )s. l,tagar;una lgricfrem Ltd. have submitted present application for the import of raw material againsi the expod of Tricyclazole Technical Solid. The application has been examined and the Depadment recommends the following norms for the present Advance Authorization application.
- ltem of Export Qty Item of lmport Qty Tttcyctazole Technical So d l k9 l Fo「mic Acid 0 714 kg
- 2- Hydrazine 4-Methyl Benzothiazole 1 184 kg This issues with the approval of competent authority ぃK蝙 ゞ Addl industHal Adviser Deptt of C&PC u O No 15022′ 4′2011‐CH‐ ‖dated、。 72015 楊 ia Min stry of Chemicals and Fert‖ zers
´11うハ｀｀ι Government of lndia Min,stry of Chemicals and Fertilizers s′ ´′。 ノ9S~ /tグ/ Sublect Advance Authonza10n applcalon from M′ s SM material against the export of Di:sodecyl phenyl DiphenyI Phosphite Rer uO No 01′ 82′ 50′782′AM‐ 16/DES‐ ‖1/696 dated uO No 01′ 82′50/718/AM-16′ DES‐‖1/699 dated Chemicals Ltd forthe import of raw Phosphite(DDPP)and 2‐ Ethyl Hexyl 3172015 3172015 ′ 「 し ＼ M/s. S.M. Chemicals. Ltd. have submitted present application for the import ol raw material against the export ol Di lsodecyl phenyl Phosphite (DDPP) and 2-Ethyl Hexyl oiphenyl Phosphite The application has been examined and the Department recommends ihe following norms for the present Advance Authorization application. Authorzation No 0310796577 dated l1 6 2015
- ltem of Export Qtv Item ol lmport Qty Dilsodecソl phenyI Phosphne(DDPP) , kg l Phenol 0234 kg
- lso Decvl Alcohol 0734 k9
- Yeliow Phosphorus 0 075 kg nce Autho「zation No 0310796312 dated 29 5 2015
- ltem of Export Qtv ndh。「lmport Qty 2 ‐Ethyl HexyI Diphenyl Phosphne ´ l kg イ Phenol 0 604kg
- Yellow Phosohorus 0 0966 kq 3 2‐Ethyl hexanol 0 386 kg This issues with lhe approval ofcompetent authority 体K鵞 ゞ Addl lndust「ial Adviser Deptt Of C&PC No 14010′64′ 2040‐CH‐ l dated 102015
^Ytlf ,6, Udyog Bharvan.Nert I)elhi. I)arcd the c.,. October. 2015 OITice Memoraldum
Subject: - Fixarion 01',ro.nr" und"r puiTTIfE I'Eiii ofprocedures (Vol.l) 2009-14 Case
of M/s Inchem Labs Prt Ltd. The urdersigned is dirccted to rcfer to DGFT U.O.No. O|B2lSO/9l4lAM-lSlDES_ 3/1328 dated the 05/0i/15 vide which applicatiou from M/s. Inchem Labs plt Ltd was sent to thrs Departmenl for fixation of norurs under para: 4.7 for the export of (Rs)4(2_Amino_l_ Hydrloxy Ethyl) Phenor Hcr. This depa.rtrne,t has exanined ttr" ,utt"i -a the fblowing norms arc fumished under para 4,7 ofHand Book ofprocedures (Vol.l) 2009-l4t UndCr SCCrctarv 10 the c:県憮 鸞 Phonc:23071162 3輩l露|]風:iざま ll:i漢.Cign Tladc, (Shi M V Singh,FTDO). UdyOg Bha、v¨,Ncw Dcllll ル″そ,2¨ F. No.350l 1/ I 7il2015-PI (Nomrs) Governnrent of hldia Ministry of Chenicals & Ferjliz_ers DepartmeDt of Pharmaceuticals S No Import Itenl Qty. Recomurended kg/kg. 1 2 Amino Acetonitriie Hcl 112 ,litro Methane Not shown in the proceiioireaiiio,r Hince nor recommetrded. つ Phcn01 l14
!,.t" fu2- Government of lndia Ministry of Chemicals and Ferlilizers Subject: Advanoe Authon2a“ on app‖ ca“ on from M′ s SHRI BAKEY BEHAR:LAL BOAD MILLS forthe import ofraw matettais againstthe export of CARVACROL Advance AuthonzatOn No 0510391639 dated 17 40 2014) U O No 017827050′ 1138/AM157DES‐ ‖υ dated 5 12 2014 Ref: M/s. SHRI BAKEY BEHARI LAL BOAD MILLS has submitted present applications for the import of raw materials against the export cf CARVACROL The application has been examined and the Department recommends the following norms for the presentAdvance Authorization application. l item of Export Qty Item of lmpori Qty CARVACROL 1 KG D‐LlMONENE(LIMONENE CITRUS TERPENE,ORANGE TERPENE,BRAZILIAN CITRuS TERPENE, STANDARD CiTRUS TERPENE ORANGE OIL) 320 KG AddL lndustr al Adviser (A K AGARWAL) Deptt of C&PC UO No 14010′ 28′2012‐ CH ll dated?092015
F. No.l50l l/621015-Pl (Nornrs) Gove,rrment of lIdia Ministry ofChefiicals & FertilizeN Departnlent of Plu naceuticals Ofllce Mentomndunr Sub.ject: - Fixalion of norms under para 4.7 of Hand Book of procedures Sun Pharma lnd stries Ltd. 弊 ,三年ζヱ´´ノ D‖鵠諜電性m円糖 (Vo o 2009 14 Casc of M/s 噺“ `∝Ⅲ a,。価 cC虞勲弥 P1lole123071 162 'lhe urrderigned is dirccted ro rcler ro DGFl U.O.No.0t/82/50,1t t67iAM tj,/DES-1,/l]08 dirlcd the l9/01/15 vide \hich rpplicalio frc r llt/s. SuI Pharma trrdusrt,i,Js Lkl \rfls scni rr) this t)elanrrcnl fbr il)ialion ot ,ornrs Lrnder par : 4.7 lbr rhc e\por.r of Azelasrine Ilydrochtoride Nxs.l Solrlion (Nasnl Sprn]) Ihis deparlmeDr has exaurined the nlalrcr and the tblkr*rrrg rrorrrrs.r|e tirrnisircd under part 4.7 oi lland Book o1 Proccdurcs (Vot.t) 2009- t4:, I:rpor( Ilem No.l Azehstinc llcl Nasal Soturiorr (Nasal Spriy) 0. t% ( i37n,cg per spr"t ) 200 MD....-.._ ,I No Export ltem No.2 Azelasti e Hcl Ophthallnic SolutioD 0.05% W/V 6ml bottle :蹴服楓 『嘲l[肝むTm“ , (ShH M V S“ ,gh,FTDO), UdyOg Bhawan,New Delhi S No :inpOrs PlЮ I)Osed Qty. Reconrnrerxie(l jU / /rnll/vrirl | AzelastiDe Hcl 3 On,l whit Opaque「Ound HDPE1 81nm scrcwed eckMedisizc bOttle 35095 Relevant, As per packirg policy , 18mm screw_On wh"c pu np and actuatOr w"h whにc cap IIIlpOrts Prono、 c(! Qty. Recommended. 3.l5rng/bottle l0rnl NatLrral ltDpE Risph";, Ste;t. Dropp"; 13mm V′ h“e opaqlJ HDPE PilFe「pHttЭ f Ri Sterile Cap for Dropper Relevarr, As per packing policy
′〃。ち ' F. No.l50l l/59/2015-Pl (Norms) Coveflrment of lndia M inistry of Chemicals & F'ertilizers Department of Pharmaceutica ls Udyog Bhawar).New Dclhi. Dated thc of Ocrober.20l5 Ofllce Memomndunr Subiect: - Fixation of Dorrls under para 4.7 of Hand Book of Prcccdures (Vol.l) 2009-14 Case of Nl/s Sur Pharrra hldustries Lid. The undersigncd i. directed to refer lo DCFT U.O.No.0l/82/50/1168/AM-15/DES-I/lli6 dated the 28/01/15 vidc \hich rpplication tiom M/s. Son Phamra lrduslries Ltd was seDl lo tltis Departnrelt for fixation ol nornts under pam: 4.7 fo[ the e\po[ oa D€snlopt?ssiD Acctrtle Nlsirl Solution 0.01'l" (Nasrl SIrAy) RT. This departnlent h^s exanrined the nralter and lhe following nortrs are f rnished under para 4.7 of Harrd Book of Procedures (Vol l) 2009-14:- Export ltcnr No.l Des[ropressin Acclate Nasa] Spmy. 0.0l%( lonrcg/o lnrl per spray) 50 MD..------lNo Exporrt Item No.2 Desrnopressin Acetate Nasal Spray SolLrtion, 0.01%, 0.lmg/ml' 5ml vial &^r"W (Banral; Khastgrr) Under Secrctary to the Covernment of lndia Phone:23071162 Directorate Geneml ofForcign Tmde, Department of Commerce. (Shri M.V. Sineh, FmO), tjdyog Bharvan. New Delhi S. No. [||rr)orts Pror)osed Qty. RecoDmended. | Desmopressin Acetat€ 0-525nrg/vial つ 20mm Snap-On White Pump Relevant, As per packing policy 3. white Actuator with Blue Cap 4. f O,rt A,rU",fyp. t fulular vial 20nrrrr Crimp Schott S. No. lmnorts Propos€d Qty. Recournerldcd. | Desmopressin Acetale 0.525m9/vial 2 2ornmSnaponhite Pump for Desmo RT NS Relevant, As per packing policy , White Actuator with Natural cap for Desmo R'I NS 4 101nl Amber Typc l Tubular via1 20[nln Crimp Schott
e /.J:y.---_ F. No.3501'1/55/201 5-Pl (Norms) Government of lndia Ministry of Chemical & Fertilizers Office Memorandum Shastri Bhawan,New Delhi. Datedi September 10 2015 Sub: Fixation of norms under pata 4.7 ol Hand Book of Procedures (Vol l) 2009-14' Application of M/s Reckitt Benckiser Healthcare lndia Ltd The undersigned is directed to refer to DGFT U O No.01l82l50l1141lAM15iDES- 3/1117 dated the 19.01.2015 vide which an application from M/s Reckitt Benckiser Healthcare lndia Ltd. was forwarded to this Department for fixation of norms for the export of Mucinex Fast-Max Cold & Sinus Liquid (OTC product). This department has examined the matter and the following norms are furnished under pata 47 ol Hand Book of Procedures (Vol.l) 2Oo9-14 - lmport item P「opyl Ga‖ ate USNF M磐W侵三1旦 Anhvdious Cn百cAcd USP Sodium Benzoate NF Red Fruns Glycerin USP ntity recomme bottle of 4 80 02859m 1 082 gm 0 128 qm 0 004 qm 28500 ｄ ｅ ｎ リ 祠 ｍ Xanthan Gum(0207499)Ph Eur usP 01569m FD&C BIue#1 FD&C Red#40 SOrbnOl s9 Ш2■(79%)ISP Ш 墜,QQL堅上J'2 Sucralose NF 2 Thrs issues with the approval of +l Cerrnpck:a,^nk tt-ircr;t ' Reievant, As per packing policy Under Secretary to the Government of lndia Phone 23071162 Department oI Commerce, (Shri MVSingh,FTDO), 21 375 qm 42 749 qm 0 071 qm 囃 ― | 一 ― ∃
ぐ/ノ. ュ′、 Government of lndia Ministry of Chemicals and Fe(ilizers Department of Chemicals and petrochemicals Subject: Advance Authorization application from M/s. imporl of raw materials against the export of (2 Hydroxy ethyl ether) Yasho lndustries Pvt Ltd for the Yapox cL 30′ 10 Hydroquinone Bls M/s. Yasho Industrjes (p) Ltd. has submitted present applications for the import of raw materials against the export of yapox CL 3O/10 Hydroquinone BIS (2- Hydroxy ethytether) The application has been examined and the Department recommends the foltowing norms forthe present Advance Authorization application. Ret UO No 01′82′050/483/AM16/DES I‖ /399 dated 7 7 2015
- ltem of Export Qty Item of lmport Oty Yapox cL 30′10 HydおquinOne BIS(2‐Hydroxy ethyl ether) l kg
- Hydroquinone 061l Kg (A,K. AGXRWAL) Add lndustna Adv ser Tel No 011_23381430 Deptt Of c&Pc FT No 14010′95′2011 dated t1 9 2015
》ドヽ′ /′ Dep∬1:lγ」 :Tli¶ ::1,」]]d」よ ::iliicals 」 攣マ|シ29′g ダ 乞｀｀ Subject Advaace Author,2al.oF appt,calion lrom i\I/s Gllhrandsen Chemtcat pvl Lrc lor the import of raw matel (EASC)..-. rrar sgarnst the Ethyl Aluminium sesqui chloride Rei. u U. No. O 1i82l050/4q0/AM 16/DES-I /li3u aate.t 8.7.:C15 ,-+ "tffi f:9""?t":i":,","#:i::f "i1Y: s,,)m.ed p'ese't appricat'ons ro'rhe import ar".,",,. cnroiiji i5;ii,ii,Ji;,1^llil,"i;#llflf":.o?;3i"r de (EASCy D,ethy, The applicatjons have been .xar-rlineo. and the Department recomme4dg ahe foilowing ncrms for the present Advance Autnorization app|calioi;. - ' *- 嚇 Diethyt etuminiLrm Chtoriae Aluminium GranuGi y'Grit 3 臓em ofE 虹 l k9 ¨ Qty TI Ethy Alumin um(TEAL) Aluminium Granules /crit 0270 kg 4Lはem of Ettort Q(v ¨ 二 m Mono ButyI Tin Tttchlonde (M8TC) l kg t. I rn tngots 0 497 kg 2=JttШ壁些n_9Hυ Granu es 0062 kq 3 Butene 1 045, i rr6d ^r tr-- -- 口:V Dibutyl Tin Cxide (DBTO) l k9 2 A um nium clt′ Granu es 0096 3 6utene-j 0 731 kg
ThiS iSSueS With the apprOVa1 0(COmpetent authOrlty 響鴨∫ il慎摯 1驚 :t::+ifSi呂:I〕モデ :総:]号も i:言:IJ:il:せ苦 t(1昔8:■=ま 1:キき旦 iawan NeW Delhi-11
9ヽア′ 〆11(枠｀～° ヮ13 F No 35011/1452015‐ PI(Norms) Govcmmcnt ofindia Miniゞrv ofChemicals&Fcrtnizers Dcparimcnt ofPharlllaccuticals Udyo8 Bhawan Ncw Dclhi Dattt■c。 `盟 つ゛5 0111cc MellloralTclum Sublcct― Fixation or nornls undcr para 4 7 of Hand Book of Proccdurcs(Vo11)2009 14 Casc Ofヽ4/s Hctcro Labs Ltd Thc undcrsigncd is dircctcd to rcfer to DCFT U O No 01/82/50/994/AM 15/DES― 3′ 1286 datcd thc 04′ 03/15 vidc WhCll appliCation fromヽ1/s HCtCro Labs Ltd、vas sc1lt tO tlぅis :場lll‖i‖htttl:III:li:1:‖ lal:1:IsI:lcξl鳳出FTI讐;j∫l卜11111」llhl:F dctails flom thc flrlll viz:‐ (a)COA ofllllportitcm ilom thc Forcign SuppliCr (b)COA of Export Product (c)Actual wastagc incurrcd 1l thC proccss (Barnali Khastgir) Phone:23071162 (Shri M.V. Singh, FTDO). Udyog Bhawan. New Delhi
5,. ottr' / / * F. No.350i l/104/2015-Pl (Norms) Covemlrlenl of hdia Ministly of Chemicals & Fertilizels DepartDleirl of Pllarmaceuticals Udyog Daled the Otllce Memorandum 胚 9髯 Bhawan,New Delhi, September. 2015 Subj ect: - Fixation of nom$ under pala 4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case of M/s Alembic Pharma Ltd. The uldersigfied is directed to refer to DGFT U.O.No. 0l /82/50/1 | i3/AM- 15/DES- 3/1039 dated the 13/01/15 vide which apPlication fionr M/s. Alembic Pharma Ltd was sent to this Department for fixation of norms under para: 4.7 for the export o:f V'ls:lltrn and Hydroc-hlorothiazide. This dcpallment has examined the Dlatter and the following norns arc fuluished under para 4.7 ofHand Book ofProcedures (vol.l) 2009-14:- Al\orms for rtan in 'l' S No ExDorl Product Nor,ms recomnrended V{lsartnr + H'(lrochlr!!!elt!!Z!!-C-l-l!.! | 80nll +12.5 lns Valsartan-- 8l 6 rn3/T.'blets 0 160 mg+125 ]]]Ц _do 163 2 mノTablets J I60 ms +25 mc dO 1632n・/Tablets 4 3201n只+12 5 mg dO 3264m・Tablets ) 120 mq+25 rng _do 326 4 n,yTablets l BINOrins ff11 lkg Vals■rtan S No Impon ltem Qty. RecoDrnended kgkg. Ｌ 一 ， l,t"tt ytlZs;-z- i1:cyuno- l, I -biphenyl-4-vl)MethvUamino)- J-methyl butanoate ethaiedioate (Biphenylvaline oxalate) 1 455kykg Melhanol 0 6371iυk8 3 fiiit ytene chloria" (or Dichloromethane) 9 409ht/kg Bi五ali Khaslgir) Under Sccrctaッlo the Govcrnn cnt ofindia PhOnc:23071162 Dircctoratc Ccncral of Forcign TradC, DcPallmCnt oF CommcrcC、 (Shn M V Singh,FTDO) Udyog Bhawan,Ncw Dcnl ∃ ヨ ∃
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9'{^h F. No.350l l/69i2015-PI (Norms) Government oflndia UdYog Bhawan,New Delhi, Dated the I 1 Septcmbcr', 2015 OtTice Memorandum Subjcct: - Fixation of norurs undet para 4.7 of Hand Book of Procedures (Vol l) 2009- 14 Case of lvl/s Apcx Pharma Ltd' The undersigned is directed to refer to DCFT U O No' 01/82150/ 1402/AM- l5/DES-3/1195 clited the 26/02115 vide which application lrorr M/s Apex Phama Ltd was senl to this Depanment for fixation of norms under pala: 4 7 tbr ih" "*pon of Pimobendan BP. This departn.rent has exatnined the matter and the following nonns are furnished under para 4.7 ofHand Book ofProcedures (Vol l) 2009- 14:- [St-t,'"-+J-.," (Balnali Khastgir ) Under Secretary to the Govemment of lndia Phone:23071 I62 Impoft Item 5.l0mg/5rrg tablet Qty. Recorntrended.
が 浮ダ F No 14010/36/2011‐ CHJ: Govemment oflnd a Ministry of Chemica s and Fert1 2erS Subject Advance Authorization application from M/s. KLJ Plasticizers Ltd. for the import of raw material against the export of KANATOL4oo O. Ref:- U.O. No. 01/821050/'1 129lAM15/DESIll/ dated 05.12.201 4 M/s. KLJ Plasticizers Ltd. have submitted present applications for the import ol raw material against lhe export of KAMTOL-4o0 (l) The applications have been examined and the Department recommends the following norms for the present Advance Authorization applications. l tem of ExpOrt Qty Item of lmport Qty KANATOL400(り l kg PHTHALIC ANHYDRIDE 0 550 kg lSO BUTANOL 0 560 kg いK蛛 Addl lndustlal Adviser of C&PC U O No 14010/36′ 2011‐CH Il dated ゛92015
Stzt ,22?- F. No.350l I/189/2015-PI (NornN) Govemment of India Ministly of Chemicals & Fertilizers Udyog Bhawan.New Delhi. Dated thc o.} Octobcr. 2015 Ot'fice Memorandum
Subject: - Fixation ol' norms under- pala 4.7 of Hand Book ol Procedures (Vol.l) 2009- l4 Case
of M/s Sll1ilax Labs Ltd. The undersigned is directed to lelel to DGFT U.O.No. 0l /82/50/1293/n M- I 5/DES l/1439 dated the l6103/li vide which application iioDr M/s. Smilax Labs Ltd was scnt lo lhis Depaflment for' fixatiorr of norms undet para: 4.7 tbr the expo ol Clopidogrel Cnmphorsulfonatc. This depaflment llas examincd the nratter and thc following norrrrs arc t'urnished undel para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14:- nncr^aal3"a (Bamali Khastgir) Utrder Secretary to the Govemment of lndia Phone:23071162 (Shi M.V. Sineb FTDO), S. No. Impo( Item I. Ihiophere-2-ethyl amine 0.sl ＾ Ｚ Alpha brolno-2-chlolo phe[yl acetic acid methyl ester 083 ＾ つ (, Camphor sulfonic acid 0455 4 Acetone 1.09 て つ I.09 ´ ０ Methvlene dichloride 5.80 7. Isopropyl acetate 1.82 8 Iriethyl amirre 0.72 Vethanol
GovermenloF tta l″ Ministr/oF Chemicals and Fertl zers 9 Subject Advance Authorization application from M/s Vivimed Labs Ltd., for the import of raw material against the expod of Reversacol Humber Blue (Advance Authorization No. 0910059156 dated 4.2.2014) {Advance Authorization No. 091006'1154 dated 30.10.2014) Ret U.O. No. 01/8250/1344/AM1s/DEglll, dated 5.3.2015 LVs Vivimed Labs Ltd.,have submitted present applications for the import of raw material against the export of Reversa@lHumber Blue The apptication have been examined and the Department recommends the following norms for the present Advance Authorization applications. This issues with the approval ot competent authority (A K ACARVVAL) Addl lndustlal Adviser Tel No 011-23381430 Item of export Otv Item of mport Qtv Reversacol Humber BlL.le 4 kg 1 4,4-DimethyI BenztthenOne 1 00 kg 2 Dimethyl Succinate 2386 kg 3 4,4-Dimethoxy Benzo phenone 1200 kg 4 Tetra Hydro Furan (THF) 4 40 kg 5 TMSA(Thmethy SIy Acete ene) 0 717 ko 6 Siralox 1 200 ko 7 DMSC15 0 817 kg 8 EDC HCL′ 1 (3‐ Dimethy Am no Propy)3 Ethv Cabodim de HCL 03,7k9 9 Aceton trle 5 600 kq lo Methanol 14 00 kg 11 Toluene 32 00 kq 12 Hexane 4900k9 帥 一 回 ;ic&pc uoto't 401o/138/2ol1-cH-ll dated J .7.20'15
/ Government of lndia Ministry ol Chemicals and Fertilizers ¢ Subject: S'り: Advance Authorization application from M/s Bayers Vapi Pvt. Ltd., for the import of raw-materials against the export of NA-CMTS (3-Furancarboxylic Acid, 2,5- dihydro-4-hydroxy-2-oxo, methyl ester, sodium salt (1:1) Ref: U.O. No. O1/82|O5O/14'1 '1l Al\r- 15/DES-3/1266, dated 4 3.2015 (Advance Authorization No. 0310790673 dated 31 '10 2014) l\r/s Bayers Vapi Pvt. Ltd.,have submitted present applicalion forthe import ofraw material againsi the export of NA-CMTS (3-Furancarboxylic Acid' 2.5-dihydro-4-hydroxy-2-oxo' methyl ester, sodium salt (1:1) The application has been examined and the Department recommends the following norms for the present Advance Authorization application- Item of lmpo.t 1 ltem of NA‐CMTS(3- Furancarboxy110 Acid, 2.5‐dihydro‐4‐hydroxy‐ 2‐oxo,methyl ester, sod um sa‖ (1:1) 0915k9 DimethyI Ma onate 0 819 kg Methyl Ch OrOacetate(MCA) Xylene / Mix- Xylene This issues with the approval of competent authority' (A K AGARVVAL) Addl lndustna AdVISer TeL No 011‐ 23381430 h DG Π Deptt OF C&PC No 15022′ 1′2015‐CH‐ H dated Iぐ 92045
ぐ/入′δ 27(
F.No. 35011, l 152/2015 Pl'Norms
Department of Pharmaceuticais
Shashtri Bhawan, New Delh! 110 OO1
Dated: 27rh August, 2015
Office Memorandum
Subiect: Application of M/s Belco Pharma for Advance Authorization for Hydrocortisone
Cream- regarding
The undersigned is directed to refer DGFT'S U.O. No. 01/82/050/1318/AM'15/DES-
lll/1370 dated 10.03.2015 on the subject mentioned above.
2.
As per Drug Manufacture Licence (OML), the export product contains 1%
Hydrocortisone. Based on 1% approved composition, each 15 tube needs 150m9
Hydrocortisone and 5 Bm tube needs 50mg Hydrocortisone. As per SlON 1931, 2% wastage on
the bulk drugs as permissible.
3.
Accordingly, 153mg for 15gm tube and 51mg for 5tm tube will be required as raw
material against the two export products.
tk(t"r.)\r
(Earnal' Khd\tgi )
Under Secretary to the Government of lndla
Phone:23071162
Shri Mahendra Vikram Singh
Foreign Trade Development Officer
Directorate General of ForeiBn Trade
udyog Bhawan, New Delhi-110001
gバたノ 『 } 一 F No 35011/192/2015-PI NollllS) Govcrnmcnt oflndia Ministry of Chemicals & Fcrtilizers l)epa ueni of Pharnaceuticals tldYog BhawatNew Delhi. Dated the I I Sepienrber. 20li Otfice Memorandum Subjecl: - Fixation of nomls ulder para 4.7 of Hatld Book of Procedures (Vol l) 2009-14 C'rse ofNl/s Eytan l-abs Ltd. 1he unclersigned is direcled lo reler to DGFT tJONo 0l/82/50/ lii6/Alvl- 1 5/DI-]S- j/14,13 dated the 16,'/03/]5 vidc which applicatiorr flonl M/s. Eytan Labs Ltd was sent to this ;;p*i,r;,ri lbr fixation of norms undet para: 4'7 for lhe export of (2R-cis)-4-Amino-l-12- tfiiJ""*v-",rtvU-l ,:-or{thioane-syll-2( t tl )-P} rimid inone Monosa licylale ,Monohvdrnfe. ii,iJ.punnl"ni fru..xanlined the attel and the ibll'-'r'rng nurms rlc lirrnished undet para'1'7 ofHand Book ofProcedures (Vol.l) 2009-14:- G鳥踪廊 Undcr Secrctary to the Co::棚 :け」 ::llを: Dircctoratc Gcncral of Forcign Trade, Departmcnt of Commcrcc, (Shn M V Singh,FTDO), Import item Glvoxylic Acid 500/・ 2,5 Di Hydrow l,4Dnhianc S No 1 0863 03784 ２ 一 ■ Cltosine Hexamethyl Disilazane 05024 08206 4 022 D Diethyl Forlnamide r●cthyl Amlnc McthylCnc Ch10idC N‐Hcxanc Sodiuln BorOhydHde Dlpotassiu n HydЮ "n PhOSphac ド狙c,おAdd 077 6 388 7 075 ０ ０ 026 9 0988 10 044
9r/:2!3 F. No.350l U350/2012-PI (Norms) Govemment oflndia Milistry ofChemical & Fertilizers Department oI Phalmaceuticals Udyog Bhawan. New Delhi, the th Septcmber. 2012. Oftice Memorandum Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s Aurobindo Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No.0l/82/50i1463/AMl2/DES-3/65 dated the 09/04/12 vide which an application from M/s Aurobindo Pharma Ltd was sent to this Department for fixation of noms under para: 4.7 for the export of Mirtazapine. This department has examined the matter and the following comments are furnished under para 4.7 ofHand Book ofProcedures (Vol.l) 2009-l4i S No lmport lte[l 1 1‐ (3‐ Hydloxymcthylpyridyl‐ 2)‐2 Phcny14-Mcthyl‐ Pipcrazlne 1306 つ 一 A.ctivated Carbou 0069 , Cyclohexane 419 4 Di isopropyl Ether (,582 ヽVethanol 0716 6 Vethvlene ChloIide 3357 2. This issues with the approval ofDirector (Cost). へヽ oヾN Ahtja) Scction Ofnccr PI‐ Nornls Directorate Geneml of Foreig[ Trade, (Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi. σ
g//^/6 29 L F. No.3 501 l/203/2015-PI (Norms) Govemment oflndia Department of Pharnlaceuticals Udyog Bhawan.New Delhi, Dated the l0 September. 2015 (Bamali Khastgir) Phone:23071162 Office Memorandum
Subject: - Fixation of norms under para 4.? of Hand Book of Procedures (Vol.l) 2009-14 Case
of tvt/s R L Fine Chem. The undercigned is directed to refer to DGFT U.O.No. 0l/82/50/144?/AM-l5iDES- 3/1454 dated the l7l03/15 vide which application from M/s. Metrochem R L Fine Chen was sent to this Department lor frxation of noms under pam: 4 7 for the expo of Nortriptyline Hcl BP/USP. ibis deparhent has examined the matter and the following norms are f'urnished under para 4.7 of Hand Book ofProcedures (Vol.l) 2009-14! DirectoBte General of Foreign Trade, S. No. lmporl Item Qty. Recommerded kg/kg. 1 I Bromo 3 Chloro ProPane 0.96 ， ¨ Ietra Hydro furan 071 Ethyl Chloro Fomlate 0.46
Da∬幣 gtth導[凝鳳|: Suり軌‐:撒l鑑器 lRttI』 T47ofHmd B。。 k ofPЮ∝ durs α do 20"■4味c Under sccrettty tO the C」堤 ]I:書話 :,ill Phonc:23071162 S NO Import Iteu Appr otinine Qty. R""orn.n6d.d- 1 r.2+4kgrnilliol] vjals
''o ' Ao-1t" ,1, F. No.350l l/ 109/2015-Pl (Norms) Govel1)menl of [ndia Ministly of Chernicals & !'ertilizerc Depanment of Pharmaceuticals Udyog Bhawan.Nelv Delhi. Dated the c)-October. 2015 OlIcc ivlemomndnm Subiect: - Fixation of norrns under- para 4.7 of Hand Book of l)rocedures (Vol.l) 2009-14 ('ase of M/s Venus Ilencdies l,td. 'lhe urdclsigncd is dirccted to rL'ler to I)GFT U.0.No. 0l/ll2/5011i54'/ANl-15/t)liS- l/1290 datcd lhe 0,U03/li ricle rvhich application tiom ltl,'s. Vcnus l{cnedics Ll(l !\as scrt to this l)epaftment for tlxation ol nornrs unclcL para: 4.7 lbr the export of Fluorourncil Solution for lnjection 250mg/5ml & 500mg/l0mt. This dcpanment has exarnined the mrltdl and the lbllowiug nomrs are lirrnished rurdcl para 4.7 of I'larld flook of l'rooedures (Vol.l) 2(x)9-14i' S. No. Inlport Itcm Qty. Recon'm1ended. l. 5-Fluorouracil BP 275mgl5rnlvial And 550m9/loml vial t\4 u"/^,rJSi^ (Bamali Khastgir) Phone:23071162 Directomte General of Foreign Trade, Depatment ofCommerce. 'A)o.2)1Ll
Ministry of Chemicals & Fenilizers Department of Phannaceuticals Udyog Bhawan,New Delhi, Dated the I .l Septenrber, 2015 Otfice Memorandun.r
Subject: - Fixation ol nonns under para 4.7 of tland Book of Plocedures (Vol.l)
2009-14 Case of M/s Vildev Interrnediates Pvt Ltd. The undersigncd is directed to refer to DGFT U.O.No. 0l/821501lr117/AM- l5/DES-3/1093 dated the l3l01/15 vide which application fiom M/s. Vildev lntermediates Pvt Ltd was sent to this Depanment for fixation ol norlrs Lrnder' para: 4.7 for the expofi of Diacerein. This deparlment has exarnined the matter and it is requested that DGFT may call complete technical details trom the tl'm as per Appendix-33. A\u.co13"t (Bamali Khastgir) Under Secretary to the Government of lndia Phone:2i071 162 Departrrent of Commerce,
う 1い拿1・ダダニタ聾卜~´ イ F. No.350l l/ I 36/2015-PI (Noms) Govelnment ollndia Ministry of Chemicals & Fefiilizers DepaftlrentofPha aceuticals Udyog Bhau'an,Ncw Delhi, Dated the f 8 octobcr. 20 I 5 Ot]ice Memolandurn
Subject: - Fixal.ion ol'norms under pala 4.7 of l-land Book of l'r'occclutes (Vol.l)
2009-14 Casc of M/s Ast x l-abs Ltd. The undersignccl is directcd to refer to DGFT Li.O.No. 0l/82/50/1007/AM- l5/DES-3/1296 dated the 05/03/15 vide which application from M/s. Astlix Labs [,td was sent to this l)epartment for' fixation of notms under patit: ,1.7 lbr: the export of Lamivudinc (Glyoxylic Acid lloutc). This dcpatrnent has cxarnincd the matter and the tbllowing nolurs are furnished under para 4.7 of I Iand Ilook of Proceclures (Vol.l) 2009-14:- S No Import Item QりRccommended kykg 1 Glyoxylic Acid 50% w/w 1 738 つ 2,5-Dihydroxy- 1,4-Dithiane 0739 3 Cytosine 0955 4 HMDS 1or1 I lexarnethl l Disilazane 1689 5 Dimethylforrramide 0877 ´ ０ Methane Sulphonic Acid 0020 7 Sodium Bolohydride 048 8 Dipotassiun I lydrogen Phosphate 19849 9 Salicvlic Acid 0832 10 Acetic Acid 02173 ll Cvclohexane 200 つ ι foluenc 290 ＾ ３ n-Hexane 592 14 Dichlorornethane 458
riethvlamine 1 544 ´ ０ sopryyl Alcohol 1.34 17. Methanol 0795 fls,cr^o"11;'" (Barnali Khastgir') Under Secretaty to the Govelnnlclll ol'llldia Phone:2107 I l6l Directolate General of Foleign 1'r'adc' Depafiment of Conrmetce,
ダ F No350H214/2015‐ PI(Nornls) Govcrllment of lndia MinistりofChcmicals&Fcrtllizcls Dcpallmcnt ofPharmaccuticals lJdYog Bhawarr.Neu Delhi. Dated the e t Oclober. 2015 Of]jce Memol.anduln Subjecl: - Fixation olnorms under para '1.7 ofHand Book ol Procedures (Vol'l) 2009 I+ Casc of M/s Malladi Drugs & Pharola Ltd. 'l'he unclersigrred is directed to refer to DCFT U.O.No.0l/82/50/1307/Atv1-15/DES i/li9l dated the I l/03/15 vide which applicatio liour M/s. N'lallacli Drugs & Phamrit Ltcl rvas scnt to this Departrnent tbr tixation ol nomls under para: 4.7 lbr thc export ol (1S,5R)-C)-'I- Methyl-s-Phcnyl-2-Orazolidinone (Chirnl Orazolidinon€) This depatlnlent has exarrined tire nratter and ii i. teq,ested that DCFT 'oay call following technical details fronl tltc ti.nl viz:- rri Conrplele lechnic,tl (let.rils r. pel ApperlJix-'t'i. ibl east pLoduction vis-i-vis Actual consunlPtion ofall irrlported irptrts duly ccfiilicd by ( (nlrirl I:\ci.e Atrlhorilre'. RlC■月ャ (Barna‖ Kllastgll) Undcr Secretary to thc Covemmcnt oflndia PhOne:23071162 Directorate General of Foreigr Trade, DepartmeDt of Commerce,
ダ.″。多 F No 35011ハ90/2015‐ P10く。rnls) Govcrnmellt Of lndia M品諄° 「鷲 mtts&FcltttS D肥:lif糧器ヽ‖璃|: 螂 ごPЮCCmκs cdo 200%HCヽC SuЦ耐― ::翌;ξlttT樹:ξ∬ paa・7 of 14: DirectOratc Gencra1 0fForcign TradC, 弱撚趙 li Under SCCrctary to tlle COV器::illll:3 S No lmpolt ltClln 0777 Nicotiuic Acid Fotnranride 388 242 261
Re' Subject: This issues with the approval of competent authority' Government ofind a Dep鮒‖ :7∬乱熙暫 :SfTξ憲 l籍れJs y/ |,ウ ジ Advance Authonzalon app calon from M′ s SHRI BAKEY BEHARI LAL BOAD MILLS fOrthe import ofraw matenals againstthe export of MENTHOL 鮮驚椰譜i鸞 d垣2f蔀 (Advance AuthOnza10n No 05103 u O No 01′ 82′ 050′2347AM167DES‐‖ν596 dated 14 07 2015 M/s. SHRI BAKEY BEHARI LAL BOAD MILLS has submitted present applications for the import of raw materials against the export of MENTHOL The aoolication has been examined and the Department recommends the following norms for the present Advance Authorization application' .Kttr Addl lndustnal AdViSer TeI N0 011‐ 23381430 Deptt oF C&PC No liiitona tzotz 'ca-tt datedい92015
- ltem of ExPort META― CRESOL ABOVE 98 50/o 2 1SO PROPYL ALCOHOL |
9,.a /(J F No 3501'1/146/20'15-Pl (Norms) Government of lndia l.4inistry of Chemical & Fertilizers Shastri Bhawan. New Delhi, Dated September 10, 2015 Office Memorandum Sub Fixation of norms under paa 4.7 ol Hand Book of Procedures (Vol'l) 2009'14' Application of M/s Stericon Pharma Pvt' Ltd' The undersigned is directed to refer to DGFT U'O No O 1/82150/1301/AM1s/DES- 3/1464 dated the 3i.03.2015 vide which an application from M/s Stericon Pharma Pvt Ltd' WaSforwardedtothlsDepartmentforfixationofnormsfortheexportof3eyedrop ior.rfation under brand Vizulize containing various amounts of sodium i vrir-"it" API in 2 eye drops and the 3rd composition do not appear to have any uiir arug. This department has examined the matter and the following norms are furnished-under para 4 7 of Hand Book of Procedures (Vol'l) 2009-14:- Export product Description QuantitY aecommended per l! El bo'lle 1.0 no Vizulize moisturizing and comfori eye droPS- 0.0'17o Description Vizulize intensive and comfort eye drops- 0 03% 1 0 no 10no. QuantitY Sodium hyaluronate 0.01 gm NaF 100 1.0 no 1 0 ml bottle Soft Botues 、 ´υhne caps Droppers ■衝呻古 ・～ ,卜ふ｀!" 1 0 no 1.0 no. 0.03 gm 3 Vtzultze Lubrlcat ng and rewetting eYe droPS 2 Directorate General of Forergn Trade (Shrl N,4 V Singh, FTDO), 10no. This issues with the aPProval of (Rai Kumar) Under Secretary to the Government of lndia Phone.23071162
Government oflndia De淵‖ :W』Ⅷ留ξ鮒霧忠鳥licJs Su'馘 鋸f:竃|:きよ:ξ譜:翻 i♂ 絲調 鵬 Mum“ Laい 田 わ耐he mport d酬 lue/」arocol BIue・12 (AdVanCe AuthOnzation No 0910060668 dated 17 7 2014) lAdvance Authonza饉on No 0910061213 dated 13 11 2014) Ref: U O No 017321050′ 1343rAM15′ PES■‖′dated 4 3 2015 麗 li測階:ぷ露げ認朧′ ::躙薔uttrn"¨面mS br he m"n d m mattd normSi:'i吉:ll!::1:,КR見‖ ix::111:1::1:itlandthe Department recOmmendsthefo10Wlng pplication Sμ 孵 Deptt of C&PC i7o?on- salfu't l-cH-tt aateo つ72015 No iiem of impott (R♀lttt72路 '静 :呈〕 :当|サ膚 21(n3 -P- Phenylene Diamine ¨ 1日ue‐ 12 This issues with fhe approval of competent authority' 一 ／ ′ ｒ ‐ ¨ 一 ¨ ¨ ´ ´ ＾ 一 一
Sがヽ 2C tl F. No.350 I 1/l 251201 5-PI (Norms) Govemnent of India Milistry ofChemicals & Fetilizers Departmert of Phat nmceLtticals Udyog Bhawan.New Dclhi. Dirted ll c .5 s.,@l'.r. l0' j 6'l'r)'' ' Ofilce Menorandtrm Slrbiect: - Fixaliol1 of uot'urs under para '1.7 of Hand Book ol Procedules (Vol.l) 2009-14 (lase of M/s Venus l{erredics Ltcl. The urdersignecl is dircctecl 1ll lcl'er to DCFI UO.No. 01/82/50/1355/AM-15/DES- l/127i dated thc 0:1/03115 vidc rvhich applicatiol fioor M/s. Ventrs Ren'tcdies Ltd was senl to this Depafimcnt lbr fixation ol-iorll1s uDder pam: 4.7 lor the expoft of Celtriaxone for Injection USP l000mg. l'his departflent has exami ed the Natter al]d the tbllo\inl rrolnrs atc tiunished under pala 4.7 of HaDd Book of Pr ocedures (Vol.l) 2009- 14:- Dircctorate GeDeral of l-oreigi Trade, f)epallment of Conlmerce, (Shri M.V. SiDgh, FTDO), lk-t^4.t+3l'^ (Banlali Klrastgir) Urder Seorelary to the GoverruDent of lndia Phone:23071162 S. No. lmpo ltem Qty. Recommended. 1 Cclir iaxone Sodium Sterile l.l6gnivial
ダ/7a'ウ F No 350144廻2045P(Norms) Government Oflndia Min stry of Chem cal&Fert‖ zers Department of Pharmaceut cals Shasttt Bhawan,New Delhi, Datedl August 26 2015 Office Memora ndum
Subject: - Fixation of norms under para 4 7 of Hand Book of Procedures (Vol.l) 2009-1a
Case of l\4/s J B. Chemicals & Pharma Ltd The undersigned is directed to refer to DGFT U.O. No. 01/82150/1438/4lvl15/DES-3/1368 dated the 10 03.2015 vide which an application from M/s. J B. Chemicals & Pharma Ltd. was senl io this Department for rlxation of norms under para; 4.7 for the export of Sugar based Lozenges and Cetylpyridinium Chloride @ 1.5 mg/Lozenge. This department has examined the matter and it is requested that DGFT may callfollowing documeni from the applicant:- i) A copy of valrd Drug Manufacturing License issued by the respective State Drug Controller indicating the composition of each medrcated lozenges ii) The lustificatron about very high percentage claimed indrcating the posstbility of recyclrng the mateflal stated to be lost dunng the manufacturing operatrons by the automatic Lozenges making machrne This issues with the approval of Deputy Secretary (DK) 6」麓Ψホ軸、 Unde「Secretary to the Covernment ofindia Phone1 23385765 Ematt barn khastOnにm (Shri M V Singh, FTDO) Udyog Bhawan, New Delhi.
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a il.. )&t F. No.l501 1/1 I 5/2015-PI (Norms) GoveLrurent oflndia Ministry of Chemicals & Iiertilizels DepallIl1ent of Pharmaceuticals art \nrt -'t o I Udyog Bha\'an'NeN Delhi' Dated the a t Oclobei. 2015 Office Mernotandum Subiectr - Fixatiol L,t',rnr,,ts urtder: par" 4 7 olHand Book olProccdules (Vol'l) 2009-1'l Casc ofMis luhilarlt Cerrerics Ltd. The unclersignecl is directed to retlr lo DGIrT U'ONo' 0l/82/50/1 122/AM 15/DES- l/1256;ated thc 05703/15 vicle $'hich aPplication fi'om M/s' Jubilarl Genetics LId N'rs sert to ifrit O"p"rtr*"t firl. ilxaliorr of norms und"t p"to' 4'7 tor the export of Spironolactone 25mg' iO*g ;.d fOO.g T.blcts. This departmcnf has cxamined thc Dattcr and it is rcqlrestcd that DCF;I'nay call followilg rccluical details from tlle fim1 viz:- (a) Copy ofl)Itrg lVlaiulactutirg LiceNe fbr the expolt prodLrcts' iii c"i,y "f Mastcr-Batch Fornula lot cach cxport iterrr duly ccditied by Qualitl''.- ('orrlrol Illclr.rrge. f'AQ^&, k'. 1B.rlr'ali Klr'tgir'' Urdel Secretary to the Covernnent of lndia Phorer2l07lL62 l)irectorate General of Fo|eign 'flade, Ilepafi ment oi Commerce. (Shri It4.V. Singh, |1Do). Udyog Bhawan, Neu Delhi
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F. No.350 I l/202120t 5_pt (No0ns) Covernment oflndia Ministry of Chemical & Fertilizers Department o fl phannaceut icals Udyog Bhawan, Nerv Delhi. the Ocbber.20l5 Olfice Memorandum subjecr. - I- rrarron ot nornr, ,nd.r. pa," 4.ToiirifElik of procedrrre{ (Vot tt 200q- t4 Care olM s Vtll.rdi Drrrgs& phalrna Lrcl. r/I46l drred lhe iI/0i/ti ',Je rhich rpptication r,on-, ul]va"tt"ii'orrr, [i,"rlirr",, ,*. .enr ro dlis Depanmerrt tbr li\arror of norms under para: J.7 ,", ,l,a;;;i;;N_i Boc_Trans -l-Hyd roxl -L-Pro Iine. I hi: deprlnlert ha. examiriecl rt" ,rurr., ura itr" loitrrri,,*,,onn. "r. li,rnished under para {.7 ot Hand Buok o[ pro..Aur.. ,voi.t1 iOOoi *,- - '" '""" 踏朧 留籠譜い Trad、 (Shri M V Singh,FTDO), UdyOg Bhawan,Ncw Dclhi Undcr secr●ゥ tO the C:堤λ鷺 :nlttIIは Phone:23071162 I{ydrOxy― [― Prolinc 摯
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F No.350t 1/182/2015-PI (Norms) . . . . Governmenl of India . " Miristry of Chemicals & Fertilizers Depart^rent of Pharmaceuticals Udyog Bhawan'New Dellri' Dated the ll SePtember' 2015 office Memorandun
Subject: - Fixation of norms rnder pa,a1.7 of Hand Book of Procedures (Vol l) 2009-14 Case
of M/s Suven Life Scicnces Ltd fhe undersignecl is directed to refer to DG|-T U'ONo 01/82/50/1i 37lAM- 1 s/DES- 3/1104 dated the 05701/15 vide which application liorr N4/s Suvcn Life Scierces l'td rvas serll i" i-f,li. o"p*r"."t for lixation oflorrns under para: 4.7 for the export ofThiabendazole This departrnent has exanired the nratter and the follouing nomrs arc furnished under pam 4'7 ol- Hand Book ofProcedurcs (f/ol l) 2009-14:- S. No. lmpoft ltem t-Chloromethyltliazole Hydrochloride 260 lfir'a-\t- (Barnali Khastgir) Phone:23071162 Di&ctorate Geneml of Foreign Trade, (Shri M.V. Sineh, FTDO),
‐ 5)μ 2'ノ F No 35011′ 220/2015 PIINorms) Govcmmcllt oflndia ヽ4inistry of ChCmiCals&Fcltiliz,rs Dcpaltl■cnl of PharmacctltiCals Udyog Bhawan Ncw Dclhi Dttcd thc il SCptCmbcr.2015 SubJcct:‐ ::lλl∫:|:illi鴨|:l]よ∫ ara 4 7 of Hand B00k Of P10ccdurcs(V011)2009-14 Casc Thc undcrsigncd is dircctcd to rcfcr to DGFT U O No 01/82/50/1390/Aヽ415/DES― 3/1361 datcd thc 10/03/15 vidcヽvhich application flolllヽ4/s Sushallt industrics LtdヽVas scnt to 辮 Ψ 出庶 肌 ∫鮨 轟 雌 郡 柵 :¶TTc瘍 ∫ (1::II::ィil,`ll::[:il) Undcr Sccrctan tO the Govemlnellt oflndia Phonc:23071162 Dttctoratc Ccncral ofForcign Tlade, Dcpaltmcnt ofCOmmcrcc, (Slm｀4 V Singh,FTDO), Udyog Blla、van,Ncw Dclhi turder para 4.? ofAand Book ofProcedures (Vol l) 2009-l4r LDpolt lteDr Qty. RecomDrended kg/kg. S No FumaIc Acid 0769 l
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g^t.. 2>3 F. No.i50l l/193/2015-PI (Norms) Govcmment oflndia Ministr,"- of Chernicals & Fertilizers Depaltlllcnt of Pharlnaceuticals Udyog Bhawan,Nerv Deliri. Dated the I I Septenrber, 2015 Olfice Menorandun Subjecl: - Fixation of norms undeL para 4.7 of Hand Book of Procedures (Vol.l) 2009- l4 Case of M/s Hetero Drugs Ltd. The undersigned is directed to refbr to DGFI'U.O.No.01/82/50/1012/AM-15/DLS- i/I410 dated the l6/03/15 vide which application from M,/s. Hetero Drugs Ltd was seil to this Department for lixatioll ol norns under para: 4.7 lbr the export of Vllacyclovir Hydrochloride. Tlis depafirrent has exarlined the oratter and the lbllowing iomls are f rnished under para 4.7 ofHand tsook ofProcedures (Vol.l) 2009-14:- [L{t u'l"'!:i (Bamali Khastgir) Under Secretary to the Government oflndia Phone:23071162 S, NO, IDport Itenl Qty. Recorinended kg/kg. 1 Diacetvl Acvclo!ir 1 114 2. Carbobenzyloxy-L-Valine 1 1824 l. N,N-Dicyclohexyl Carbodimidc 1 061 4 4-Diriethylamino Pylidine 0028 ^Y:--""'
O ^t^ ) \L, F. No.i50 I l/165/2015-PI (Nomrs) Cove|nment of lndin Ministry olCherrlicals & Irer.tilizer.s Deparhuent of Pharnraceuticals Udyog Bhawan.New De)hi. Dated rhe oTOcrober. 20 l5 Office Menrorandunr
Subject: - Fixation of norms under para 4.7 of Hard Book of procedures (Vol.l) 2009-14 Case
of M/s Hetero Labs Ltd. The undersigned is direcred to refer to DGFT U.O.No.0l/82/50/tot4/AM-15/DES_ 3/1432 dated the 16103/15 vide which application fron M/s. Heterc Labs Ltd was sent to this Depart,nelt for fixation of norms under para: 4.7 for. tlre export of Losartan potassium. This depaftment has examined the matter and the following norms are furnished under para 4.7 of Hand Book ofProcedures (Vol.l) 2009-14:- S NO Imporl ltem Qty. Reconrnlcrded kgkg. 1 l-Butyl-,1-Chlor)-5-F-ornryl Imidazole 050 つ ル +-Brorro Methyl-l-CyaDo Bipher)yl 080 一 Ｊ Sodiunl BO10hvd ide 0048 4 Toluene ′ ● N4erhanol 085 ′ ０ N-Methvl Pvnolidone 0769 ぷ蝙 Under Secretary to the Cove lnent of India Phone:23071162 Dircctoratc Ccncral of Foreign Tradc, Dcpartment ofConlnncrcc (Slul M V Singh,FTDO) Udyog Bhawan,Ncw Delhi
Government of lndia lVinistry of Chemicals and Fertilizers Sublect:Advance AuthoHzalon app“ calon iom M/s Lake Land Chemica:s:ndia Ltd forthe importofraw matenalaga nstthe exportof PHENOXY ETHANOL(SSL&AF) Ref: U O No 01′ 82750′1389′AM-157DES― ‖ l′28 dated 1 5 2015 M′s Lake Land Chemicals lndia Ltd have submitted present applcation forthe import of raw matettal againstine export of PHENOXY ETHANOL(SSL 8AF) The app‖ cation has been examined and the Department recommends the fonOwing norms for the present Advance Authorization application nce Autho「izaton No 031079 253 dated 20 11 2014 1 ltem of Export Qtv Item of lmport Qty PHENOXY ETHANOL (SSL&AF) l kg l PHENOL 0 750 kg 2 ETHYLENE OXIDE 0 340 kg This issues with the approval ol competent authority. 凋IM｀ lι プ。口=琴g .隋 ` AddI Industrial Adv ser ptt o(C&PC No 14010′ 812011‐CHJl datedP ヽ02015
s/ t/r. J+{ F. No.350l I/168/201 5-PI (Norns) Covemrirent of India Ministry ofChemicals & Fe(ilizers ■6し 27る tJclyog Bhawan.Ncw Delhi. Daled the o.' Oclobcr. 20li Ollicc Merrorandunr
Subject: - Fixation ol nonns undcr pall :1.7 of Hand Book ol ProccdLrrcs (Vol.l) 2009,1,+ Case
of M/s Medreich l-td. 1he undc|sigflecl is directed to rclir to DGFT U.O.No. 0l/82/50/l]57i.\NI-l5.1DES lil.l.l0 dated lhc l6/01115 vide uhich application lronr M/s. lvledrcich Lld \as scnr ro rhis l)epartmenl lbr lixalion ol norus Lrnder parai 4.7 ibr the export ol'Amoricillin and l,otassium Chvulanate 'l ablets. Tlris department has examined tlte ltlatter and thc lbllouing nornrs e|r: tiuuished under pam 4.7 oi Hand Book ol l'rocedures (Vol-l) 2009-l,l:- 己靡 酔 Under Secretary to the Govemnent oflndia Phone:23071162 Directoratc Ceneral ofForcign Tradc, Department of Commcrcc, (Sllli M V Singh,FTDO), S No Import Itenl Qty. Recon rendcd. 1 Amoxicillin Trilrvdlate 585.36mg/tablet つ 一 Potassium Clavulanate+Avicel( I : I ) 303.6mg/tablet
?/ t /. 2+)- ,=..-- F. No.i50l l/154/2015-PI (Norms) Covernmert oflndia Ministly ol Chemicals & Fertilizels D€Pa11ment of Phal.maceuticals Ud)og Blrarvar.Ne\ Delhi. Dated the / / seplember. 2015 Office Menrorandum
Subject: - F ixation ol' uor-nls unclet pala 4.7 of Hand Book ol Plocedrn es (Vol l) 2009- l4 Case
of M/s Medreich Ltd. The uldersigned is directed to tefer to DGFT U'ONo 0l /82/50/ l47r'A M- I s/DIIS- 3/1i67 dated the 1d/03/15 vide which appticatiol lroDr M/s Medreich L1d rvas serrt to this tl.non."rr fot' lixation of rlorDls urdel para: 4'7 for thc expo( of Amoricillin tnd Ii,irrirr"" pr,^,.irm 'l'ablcts 625mg. Tliis clepa(ment has exanrined lhe nlatter and the t'olfoi.g ilort u* tfrnished under pari 4'7 of Hand Book ol Procedutes (Vol l) 2009- l:l:- $qtt^m\ro (Bainali Khastgir) Uflder Secretary to the Govemnent of lndia Phone:23071162 (Shd M.V. Snrgh, [TDO), Udyog Bhawao, New Delhi Quantity recommended. l Tablct l5l.8mg+151.8=303.6m9 Potassium+ Micro Cellulose (l: l) As per packing PolicY ALU Bottom blister Pack Export lten] Desc ption and Tablcts Qua11tity
F No35011/228/2015 PI(Norms) Govcmmcllt ofindia Minist,Of Chcmicals&Fcnnizcrs Dcpartmcnl ofPharmacctiticals Udyog Bhawan NCW Dc hL Datcd thc 0 8 0ctObCr 2015 St blc∝ :罵|∫熾T器よ ltrp鳥齢苧器調器ざ PЮcc“ es Ⅳdl)200'Hいヽ 3′ 13641:L::|‖ :ri瀞::りlξサ |よ:‖露 cPa苦輩 :1:[♀:ill:|||llli苦t11:|‖illllli: 諮 lil∬‖虚 rc鶴瓢llT器:出iξT dctans frolln thc flrm viz■ 8響燃∬ mi跳:螺T品爛l舗iざh"にd hpus tty∝面 idけ Ccntral Excisc Authoritics 6al鵬鵠計 UndcrSccrctarytothCCoVCrnntcntOflndl, Directorale Geleral of Foreign Trade' Deparlnlent olConlmerce. (Shti M.V. Singh, FTDO). lldyog Bha*an, New Delhi gノ PhOnc:23071162
≦ Pンμ ユ9ノ F. No.350l 1/156/2015-PI (Norms) Government of India Ministry ofCherticals & Fertilizels Depadment of Pharmaceuticals Udyog Bluwarl.Nelv Delhi. Dated the l/ septenlber.20l5 Omce Memoraodum Strbject: - Fixation of nornls undet para 4.? of Hand Book of Procedures (Vol l) 2009- l4 Case oflvl/s PVS Labs Ltd. The undersigned is directed to refer to DCFT U O No' 0U82I50/1292/AM-15/DES- 3i1389 dated the lrO3/15 vide which applicatior fiom M/s PVS Labs Ltd was sent to this Deoanment for fixation ofnorms under Pam: 4.7 for the export ofTohracurc This deparlmenl i-".'..""ri*Jrrt" *"tier and the followirrg norms are ftlmished under para 4 7 of lland Book of Procedures (Vol.l) 2009-14:- S No Import lten Raw matcrial Description Quantity A.PI to be illlported Juantity rccoulerded 1 Toltracurc 2.5 50001itrc Toltrazuril 25g litre つ Ioltrcure 5 1 0001itrc Toltrazuril 50gnVlitre D Flor‐ 100 25001itlc Flolfcnicol 100gn■litrc 4 Flor-200 12501itc Florfenicol 200gm/litre 5 Mulin Powder 5000kg Tiamulin Hydrogen Fumarate 100gm′ kg ´ ０ Diclazu 200001itF Diclazuril 10gm/htlC フ rilmicos‐liquid 1 2551itrc TilmicOSin Phosphatc 279.8139m/litre 8 ilnlicos-20 '72kg Tilmicosin Phosphate 223 385gn1/k8 rlょにし、ク v:ヽまン 4 Barnan Khastgiう Undcr Secrcttt tO thC Govcmment oflndia PhOnc:23071162 Dircctoratc Ccncra1 0f Forcign Trade, Dcpalullcnt of COmmcrcc, (Shri M V Singh,FTDO), Udyog Bhawan,Ncw DcHli
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RA may take approplate action as per the decision of Noms Commltee
9A^ 233 F. No.3501 U78/2015-PI (Nomts) Covemnent oflndia Ministry o「Chcmicals&Fcllnizcrs Dcparinlcnt of Phannaccuticals Datcd thc li SCptCmbcr 2015 oince Mcmorandum su●ccl Fix"おぃor nonns undcr para 4 7 of Hand BoOk of P10ccdurcs(Vo11)2009 14 Casc Of M/s HcИ,1)harma PVt Ltd Thc undcrsigncd is dilcctcd to rcfcr to DGFT U O No 01/82′ 50/1425′ AM 15′ DES‐ 3/1190 datcd thc 26/02′ 15 vidc Which applicatlon flolln N4/s Hcna Pharma Pvt Lta w.ls scllt t0 lnt脚勝端#柵島∬滞W」I淵:∬鳳港 L∬悧ぶ1:朧猟 :1111 ttlmishcd undcr para 4 7 of Hand Book Of Proccdurcs(V011)2009-14:‐ Ltpoft llenl 1,3 Propanediol-99% Min Dilcctorttc Ccncral of Folcign Tradc, DcPalllllCnt oF Conlmcrec, (Shriヽ4 V Singh,FTDO). lBM) Undcr SCCretay to ulc COvenlment oflndia Phonc:23071162 Qty. RecommeDded kg/kg. 0475
ゞ生 "` 41δ t F No 35011/118′ 2015‐PI(Norns) Govcrnmcnt oflndia ヽイinistry of ChCmicals&Fcltilizcrs Dcparlmcnt of PharmaccutiCals undcr para 4 7 of Hand B00k Of Proccdurcs(Voll)2009■ 4■ Udyog BhnWan Ncw DclhL Datcd thc′ ,｀ SCptcnlbcr 201 5 SubJCCt:― ::喘lξl::∬ll澪::|:よ[ll:チ t:]帯:i:号:::iorlroccdurcs(VO11)2009-14 CasC 釧3081鷺鮒 音 お1:ヽlξI訛1猛精」l DGFT UONo O1/8ν 5m38夕AM」yDES on fromヽ4/s lndoco RclllcdiCS Ltd was SCnt to 鵠詰FT辮器常 :nll農場‖ :ilど1∬鳥席ぶ鵬:l諜撃 r甜譜 G靡需 Undcr SCCletary to tllC Cov;l:I::兆 1;キIを3 Department of Conmlerce. iJdyog Bhawan, New Delhi 5J mg/ 5mg CaPsule And 10.2 mg/ 10 mg CaPsule lnrport Iterrr Qty. I{econnncodc(|.
Case No 195′
13′ 82‐ A LC4′ 2014 11o Flに 'ん′ 2'ノ Patv Nalne HETEROしABS LIMITED RLAF e Mcet N″ Date:7/82‐ status:Approved ALC4′2015 24072015 Lic No′ Date:0910061301 DeFer :01′ 8フ050/01098′ AM15′ 0'247040700465′AMi5′ 251:2014 Decision : The Committee in light of comment of D/o Pharmaceuticals forwarded vide o.M.No.35o11/540/2014'Pl (Norms) dated March 2015 decided to ratiry norms as details Eiven beloworas applied by the firm whichever is less: Ixpo( product Oty lmport items Otv. in ke. Ramipril ０ い ― 、 1 BENZYL(CIS ENDO)OCTAHYDRO CYCLOPENTA (B)PYRROLE‐ 2(S) CARBOXYLATE HYDROCHLORIDE 083 ， 一 N‐[1(S)CARBOETHOXY‐ 3‐PHENYL PROPYL卜(S)AしANINE 098 NN‐DiCYCLOHEXYL CARBODHMIDE 0858 RA may take further necessary action as per decision ofNC.
9zA :V1 F. No.350l U98l2015-PI (Nouns) Govemment of lndia Udyog BIuwan.New Delhi. Dated the ll Septenrber,2015 OIfice Memorandum
Subject: - Fixation of nonns Lrnder pam 4.7 of Hand Book of Procedures (vol.l) 2009-14 Case
of M/s BDR Pharma International Pvt L1d. The undersigned is directed to refer to DCFT U.O.No.0l/82/50/1398/Al\4-1SIDES- 3/l198 dated the 26102115 vide which application from M/s. BDR Pharma International Pvt [,td was sent to this Depafiment fbr fixation of nomrs under para: 4.7 fot the expolt of Chrithromycin UsP. This departolent has examined the matter and the following nornts are furnished under para 4.7 of Hand Book of Procedures (Vol,l) 2009-14:- S. No. Import Itcm Erythromyciu, 6-O-methyl-2,4-bis-O-(trimetylsilyl) 9- [O-( l -ethoxy- l-Nethylethyl) oxime] (N-1) 2.0 kg/kg fAo.!..^FiY (Banali Khastgir) Phone:23071 162 DepartrDent of Commerce, (Shli M.V. Singh, FTDO),
V/ ぐハ 29} GoVernment ofindia Dep酬1:需R脚:『ξ謂霧般 i馨iicJs Sutte“ 佃 ::liT鑑]F::]『l:[lげ場 Br■ :TE」燿‖ 1寵鮎瀧&1紫 Ben2ソI Chlonde Ref: UO No 01′ 82′050707432/AM‐ 15′DES‐ ‖ l′1162 dated 26 2 2015 Pvt Ltd haVe submitted present app"CatiOn for the import of raw 3‐ Ch10rO BenZyI Ch10nde′ Meta Ch10「O Benzyl Chloride The apolication has been examined and the Department recommends the ".rrn" forin"'r"** Advance Authorization application This issues with the approval of competent authority' M/s. Benzo Chem lndustries material against the export of following Tel N0 011‐23381430 h-11 DESJ Deptl of C&PC mCHJdaed 〔1,92015 Item of ExPort
- freta Chloro Toluene nzJ Clloride/Meta Chloro Benzyl 0 01l k9 … SObutyЮ Nl副e
Sふ′9ゞ qキ "イ il'.ritiJ ,"a"t p"* +.7 oi Hand Book of Procedures (v ol l) 2009- 14: - F No 35011/2482015 PI(Norms) Govcrlll lcnl of lndia Minist,orChcmicals&Fcllnizcrs Depallnlcht ofPhalmacctlticals Udyog Bhawan,New Dcthi D“cd hCcヽ澪,貯 2015 酬 oFPЮccdurs Ⅳd0 200'14 Casc Su・…:蹴ξ l晶∬ 8:∬l“ m47〆 I Thc undcrsigncd is dirccted to rclt・rtoDGFTUONo 01/82/50/1102/AM‐ 15/DES‐ 3/41 dated thc 12/05/15 vidC WhiCh applic“ lon fronl M/s llCtcro Drugs Ltd was sCnt to this × i∬器究路鳳:出suttiぽtlL串率1ドЪ l鳥縄 r器‖ P寵 Dircctoratc Ccncla1 0fForcign Tradc, Dcparlmcnt of COlllmcrcc. (Sllri M V Sillgll,FTDO), Udyog Bhawan,Ncw Delhi lmpofi Item Qty. Reconurended kg/kg. S No 135 | 1[(3.3 DiphcnylplopyD Mcthyl‐ Alllino]2-Mcthy卜2 PrOpanol 1 51 つ ４ -,GDimethyl-5-Methoxy Carbo11yl-4-(3-N ttrophenyU- 1,4-Dihydro Pyridine-3-Carboxylic Acid 0594 3 rimct,l Cll10rOsnallc Ga鮒船饗辞 UndcrSCCretalytotheGoI:I:l』り」 ;;キlt]
S/ilo Joz- F. No.350l l/24712015-PI (Nornrs) CoveroDrent of Lldia Ministry ofChenlicals & Fertilizers Depa ment of Pharmaceuticals 4)n't* 4+ Udyog Bhawarl.New Delhi. Dated thc o 5 Sef*tbffi 2015 Olfice Menrorandum Subiect: - FixatioD oi nolms undet para 4.7 of Hand Book ol Procedures (vol.l) 2009- l'l Case of M/s Hetero Labs Ltd. 'l he uDdersignecl is directed to rel'er to DCFI U.ONo.01/82/50/1l0i/AM-li/l)liS-l/10 dated thc l2l05/15 vide *hich application l'roDr M/s. Flctero Labs Lld \'as scnt to this l)epartment for fixation of lorms urldel para: 4.7. tbl the export of Levetirncetrn. This department has examined the aftet and the following norms are l'urnished under Parl :1.7 oi HaId Book ofProcedures (Vol.l) 2009-14:- S. No. lD1poft ltem Qty. ReconlDrerdcd lg/kg. 1 S(+)-2-Amino ButynDride Hcl 0.95 2 Methylene Chloride 2.s2 ● Ｄ \cetone 0.60 f\fu^b^|ef^ (Barnaii Khastgir) Under Secretary to the Governnenl ol'lndia Phone:23071162 Directomte General of Foreign Trade, Depanment of Comnrerce. (Slti M.V. Singh, FTDO). 〒
s4 2q6 F. No.350l l/52l2015-PI (Norms) Government oflndia l)epartment of PharmaccLrticals Udyog Bhawan.New Delhi, Dated the September. 2015 Office Memorandum Subiect: - Fixation ofnorms under para 4.7 ofHand Book ofProcedures (Vol.l) 2009-14 Case of M/s Micro Labs Ltd. lhe uDdersigned is directed to reler to DCFI U.O No. .0.1/82/50/ I l5l/AM- l5/DES- i/I060 dated the Iliol/15 vide which application from Ws. l$lA"lubt Pvt Ltd was sent ro this Depa{menl for fixation of uonns under paia: 4.7 for the expofl of Premix for Nifuroxazide Capsules ol 362 mg Containing 200mg Nifurorazide. This department has examined the mrlter and the lollowing noflns ale furnished under para 4.7 of Hand Book of Proccdures (Vol.l) 2009- I 4:- (BamaliKhastgi0 Under Secretary to the Government oflndia Phone:23071162 Dircctomte General of Foreign Trade, (Shri M.v. Singh, FTDO), こ ´ S, NO, Inrpo11 Ilenr Qty. Recommended kg,kg. | Nitt1lo)azidc EP 05775
V^
qeLt
F. No.l50l 1/80,20l5-PI (Norms)
Covernment oflndia
D€partment of Pharmaceuticals
Udyog Bhawan,New Delhi,
Datedthe September,20l5
Ofhce Memorandum
Subject: - Fixation of norms under para 4.? of Hand Book of Procedures (Vol l) 2009-14 Case
of M/s Danopharm Chemicals Pvt Ltd. The undersigned is directed to refer to DGFT U.O.No. 0l/82l/50/ 1383/AM- 15/DES- 3/1186 dated the 26102115 vide which application from IWs. Danopharm Chemicals Pvt Ltd was sent to this Department for fixation ofnorms under para: 4.7 for the expor( of l{4 Mcthyl Phenyt)-4,4,4 Tril'iuorobutane-lJ-Dione). This department ias examined the.matter and the following norms are fttrnished under para 4.7 of Hand Book ofProcedures (Vol l) 2009-l4i (Barnali Khastgir) Under Secretary lo the Covemment of lndia Phone:23071162 ／ ／ ／ ′ ／ ／ ′ ／ ,87- S. No. lmport ltem Qty. Recommended kg,4(8. | 4-Methyl Acetophenone 0.61 ＾ Ｚ Irifluoro Acelic Acid 0.61 lso Propyl Alcohol 0523 4 foluene 0.46 Sodium Methoxide Powder 0346
9^L Sダ Government of lndia l,Iinistry of Chemicals and Fertilizers
Subject: Advance Authorization application from M/s. Swati Menthol & Allied Chemical
Ltd. for the import of raw material against the export of TERPINYL ACETATE ANDPINE OlL.
( Advance Authorization No. 2910025185 daled 17.12.2014
( Advance Authorization No. 2910025'174 daled 27.11.2014)
M/s. Swati Menihol & Allied Chemical Ltd.have submitted present application for the import of
raw materialagainst the export of TERPINYLACETATE ANDPINE OlL..
The application has been examined and the Department recommends the following norms for
the presentAdvance Authorization application.
( Advance Authorization No. 2910025185 daled 17 12.2014]-
(Advance Autho百2atiOn No 2910025174 dated 27 11 2014)
ヘ
′
′
ノ
(A K AGARWAL)
Addl lndustrial AdViSe「
TeL No 011‐ 23381430
Deptt Of C&PCUO No
- ltem of Export Qty Item of lmport Qty １ ２ TERPINYL ACETATE PlNE O L 024k9 0 48 kg l SY VAPINE B80′ 82 (BETA PINENE) l kg 1 にem of Export Oty Item of lmport Qty l DIHYDROMYRCENOL , kg l GUM TURPENTINE OIL 1 95 kg
9N, . 3oL7 F No35011/158/2015 PI(Norms) Govcrnlllcnt of lndia Min`t,of ChcmicJs&Fcn‖ izcrs Dcpartmcnt ofPharmaccuticals Udyog Dated the I Bhawan Ncw Dclhi l scptcmbcr.2015 Office Memorandum
Subject: - Fixation ofnornrs under para 4 7 ofHand Book ofProcedures (Vol l) 2009-14 Case
of M/s Ranbaxy Labs Ltd. The undersigned is directed to refer to DGFT UONo 0l /82/50/1303/AM- I 5/l)ES- 3/1419 dated the l2h3l15 vide which aPplication from M/s Ranbaxy Labs Ltd wassenttothis Departmert for fixation of norms uirder para: 4 7 fot llr: elport of Lamivudine 150 fU6il""iopin" 200 MG+Zidovudine 300 MG Tablets. This departmert has examined the ,natter und tire following norms are fumished under para 4 7 of Hand Book of Procedures (Vol,l) 2009-14:- ぶ濡朧訥 Undcr Sccrctary to thC Covcrnmcnt of llldia Phonc:23071162 Dircctoratc Cencral ofForcign Tradc, Dcpaltmcnt of Commcrcc, (Sllri M V Sinま,FTDO). Udyog Bhanan,New Delhi S No lmpor't ltert Raw matelial Description Quantity API to be imported Quantity pernrissible per tablet 1 Lami■■ldinc 150 mg+Ncvirapinc 200mg 十Zidovudinc 300mg tablets l tablct Lamivudine 153 g Nevirepine 204 mg ZidovLrdine 306 ntg つ Lamlvudine 150mg +Zidovudinc 300mg tablCtS l tablct Latllivudire )53 mg Zidovudire 106 mg ――一-1 刊
Sublect: Rer l/o. f o 6 Government of lndia Ministry of Chemicals and Ferlilizers Advance Authon2auOn apprcatiOn from M/s Deepak NIttte Ltd for the import of raw material againstthe export of 3-Hyd「oxy AcetOphenone U O No 01′ 82′ 050′ 1430/AM-15′ DES‐ ‖ |′1175,dated 26 02 2015 M/s. Deepak Nitrite Ltd have submitted present application for the import of raw material against the export of & Hydroxy Acetophenone. The application has been examined and the Department recommends lhe following norms for the prssent Advance Authorization application. This issues with the approval of competent authority' 体儡 ´ Addl lndustrial AdviSer
- Item of Export Qty Item of lmport Qty 3- Hydroxy AcetoPhenone l k9 3-NITROACETO PHENONE 1 780 kg Deptt Of C&PC U O No 14010′ 36′2012‐CHJl
パリ 9/ AtD 50 N- F. No.350l l/16212015-PI (Nonns) Govemment of India Depaft ment of Phalmaceuticals / Udyo_O Bhawan Ncw Dcthi DatcdthccS OCtObC1 2015 輌 … 鋼 面m Ol lDm銅 ∝p酬 ざR∝出げ¨ Ⅳ山 ¨ "■ 4Qヾ Of卜4/s ind‐ Sヽヽ i(ヽLabs I.td 「hc undCrsignctl is directcd lo rclcr to DGFI U O No 01/82/50/1480/Aヽ 4-15/DLS― 3/1452d● cd tllC 1 7′ 03/1 5 vidc WhiCh applictalion fltlll M′ S ind―Swirl Labs litd was scnl lo ll｀ S 監ぜ‖塁i鼎l熙蹴ll鰤よ晰ピTlll黒1鷺ξ∬:Wttfl器lF臨濯t of applicatioll llonl tlic nrl〕1 Li.) tllld赫OmμOtlcGo準朧1鼎職 : Department of Commerce. (Shri M.V. Sineh, FTDO)'
Government of lndia Department ot Chemicals and Petrochemicals 卸〃¨うし SubleCt: Advance Authonza10n apphcation frOm M′ s Balali Amines Pvl Ltd fo「the import of raw material against the export of N―METHYL‐2‐PYRROLIDONE (Advance AuthO百zationNo 3110065116 dated2122014) ReF UO No 01′ 821050′ 1455′ AM 15′ DES‐ ‖ 1′1166.dated 26 2 2015 M/s Ba ali Am nes Pvl Ltd have subm tled present appica‖On forthe import of raw malena against the exportof N― METHYL-2-PYRROL DONE The applcaton has been examined and the Department recommends the following noms fO「 the present Advance AuthOrizat on appication 3 ltem of Expoil Otv Item of lmporl Q" N‐METHYL‐2‐PYRROL DONE l k9 4 Methanol 0370 kg 2 Ammonia Anhydrous 0160 kg 3 1,4 Butanediol 1 044 kg 4. MethYlamine Catalyst 0 008 kg 5 GBL Catayst 0 075 kq This issues with the approva I of com petent authority. ＼月イMahende「Ⅵkram Snoh FTDOイDESJn O/o DGFT Udv00 Bhawan New Dd“ -lL Sヽ92015 Dept oF C&PCuo No (A K ACARWAL) Add1 lndustnal Advise「
/ Goveinment oflnd a Dep∬朧 |:」:T珊:野ξ」 ]『占1:i:11∽に suue∝ 盤l載鼎IW:l;]TRⅧη WSBJ¨ Am ms'眈Ш brhe h"n d ttw L‐2‐PYRROLIDONE 脚 ;:1寵駕鵬恩:l‖:]侶腿 ::話:堀:li:田 Rer u O No 01′ 820507667 AM‐ 16/DES‖ |″7,dated 16 6 2015 鰐諦 鞣 AW書 服 措 l爾 ぷ ど 口esent"メ酬∞お「慟 “ m"rt Of ttW m載昴J"J耐 The applcation has been eXamined and the Depament recommendS he fO‖ OWing nomS fOr lhe present Advance AuthOn2abOn applicatton Item of lmport Qtv 0882 k9 ^f Ol. N‐ETHYL 2 PYRROL:DONE l kg I '13 Butanedro -2. Ammonia AnhYdrous 0167 kg :. etil4 nbonot 1eS% minimum denatured) 0504 k9 4 6thv amine Catalyst 0 001 kg This issueswith the approvalof competent authority 詰絣 ヾ ■p2∝5
/ F. No 3501l/7ql2015-PI (Norms) ^14 Government of India ^, ) c Yl' Ministry of Chemicals & Fettilize"s 'l '//"' Department of Pha'naceullcals udyog Bhrwan'Ne\' Delhi' Dated the I i Septenlber' 2015 Ollice Memorandum Subiect: . Fixation oI nornrs under pu,n 4.7 of H^,d Book of Plocedules (Vol.I) 2009-] 4 Case of M/s Dhanuka Labs Ltd Thc undCrsigncd is directcd to lcFcr lo DGFT U O No 01/82/50/1426′ AM 15/DES― 構撚懺灘駐壽1出雌鸞‖∬蒲鷲甫諏 iギ ofHand B00k OfProccdurcs(VOll)2009‐ 14: ヽ D"cctOratc Ccncra1 0f rorcign Tradc, 斑 ]皿i熙憬 li ぉ酬紬蠅→ Undcr Secrctary to thC CoV:I:I::」 」:;キIを〕 2263 +tt"nylu""tu^id"*iChloro'*tl'tyt Cephalosporanic id Para Metlroxy Benzyl Ester (GCLE) riphenyl PhosPhine 12556 etra Hydro l'uran Butyl Aoetate hrport ltem 011 242 2425 4414 274 1 397 0155 ChloridC
,,n:y' UdYog Bhauarr'\err Dellri' D.rted the c? O.tobcr' 20 l i Of]jce Menrorandun Subiect: - Fixation of llofnls undel para 4J ol.Hand Book of Procedur.es (Vol,I) 2()09.1.1 Casc oi 1vl/s Dr. Rcddv's Labs Lld. The ultdersiglecl is clirected to retcr ro DGFT IJ O'No' 0 ] /82/i0/ I 105/AM- I s/DhS li 80 a"t"a tfr"-iolOoil:"ride lvhiclr applicaiion fionr M/s' Dr' lteddy s Labs l-td was sent to this ii"p",arlt-t.t'i",ion ol'norms'uncler para:. '1 1 lir thc e\port ol Finasteride-(l'orm ltl)' This deoarttnent ltas er.lntined the mattcl'ltrld tll( lbllowing llo ns rrc lirrnislrcJ lllldcr lr'lr'' L7 ofHaui Book ofProccdurc. (Vol.l) 2u0q l4:' F. No.350l l/23512015-PI (Norms) Government of lndia Ministy ofChemicals & Fertilizers Depal1mert of Pharmaceuticals lmport Item Qty. Reconmended [g/kg. S. No. l l10 | IO*o-4-Aru-5-o-Androstane-17-b-CarboxyhcAcld t.41 つ BSTFA IBis-('Irimethylsilyl) Tdlluoro Acetamloel 0.86 ０ つ DOq 12,3-nichloro-5,6-Dicynobcnzo Qumruel Methylene Chloride 1017 4 Directorate General of Foreign Trade. Department of Comnlerce. (SlTi M.V. Singh, FTDO), Udyog Bhawaq New Delhi I
9^t,. jl7- F. No.350l l/l4ll2015-Pl (Nonns) Govemment oflndia tldyog Bhawan,New Delhi, Dated the Oclober.2015 Office Memorandum
Subject: - F ixaiion of norms under para 4.7 of Hand Book of Procedures (Vol l) 2009-14 Case
of M/s Morepen Labs Ltd. The undersigned is dirccted to refer to DGFT U'ONo 0l/82/50/ 1478/AM- I5/DES- 3/1318 dated the 05/03/15 vide which application from M/s Morepen t'abs Ltd was senl loihis DeDartrnent tbr firatton of norms Llndel para: 4-7 for the expoft oiAtowastatin Calcium This department has examined tlle matter cnd the following norms are furnished under para 4 7 of Hand Boot ol Procedurcs (Vol.lr 200q-14:- (Barlla‖ Khがtgr) Undcr SCCrctary to thc Covcrnmcnt ofindia Phonc:23071162 Dircctoratc Ccncra1 0fForcien TttdC, il轍熙Illi 己 I lu*o-Alph^-[2-M.rhyl- l -Oxopropyl]-Gamma- Diphenyl Benzene Butanamide RCrst l, t -Dtrnethylethy!6-Cyanomerhyl-2,2- imethyl- 1,3-Dioxane4-Acetate lcnc Ch10ride iisopropyl Ether Qty. Recommended kg,Acg. 0994 S No lmporl Item つ 0708 4354 D 3791 4
、ァ/μ`アノヮ F. No.350l l/24612015-Pt (Noms) Covelnnrent of lndia Ministly of Chemicals & Ferlilizers Depaturelrt of Pharmaceuticals lJdYog Bhalvau.Nerv Delhi. Datcd the t i SePtctrrber. 2015 OIIcc Menrorandunl Subjecl: - Fixation of l1onns ulder para 4-7 of Hand Book oi Procedures (Vol'l) 2009- 14 Casc of M/s Iletero l.abs t,td. 'f he under signed is clirected to rct'er to DGFT U O'No 0l/82/50/1285/AM- l 5/L)hS l/l l dated the l2105/li vidc which apflication tiolD N4/s' Hetero Labs Ltd was sent to this O"p"u"r"u fbr fixalioll u,'no.,is u,,.le, para: 4 7- lor tllc e\polt oI Drrunrl'iI Anlorphous' il',i. a"pnrtnr"nt t,u, "\itnlilcd the Dlattcr xnd the tbllowin!. nur nr\ are ftu rrislrrd undcr pirn :l'7 of Harrd Book of Ptocedtrrcs (Vol.l) 2009- l4:- 化ヽし ^リトロ (BamaH Khastgill Under SCCrclary to tllC Co::I:::け lliキ1を3 Dilcctoratc CCncra1 0fForcign Tradc. DcPartmellt of COnlnlcrcc (slulヽ4 V Singh,FTDO), 1」dyog Bha■an,Ncw Delhi Qty. Rccomnended kgkg S.3S1J1T.,tI]utoxy Calbonyl Amino)-1,2-Epoxy- sobutyl Amine "S.6"R)-T.tt"yd.4-M"tLoxy Furo(3,4-b)Furan-2- etrahydrofuran ithium Borohydride cetonitrile .N-DisuccininridYl Cabonate 0854 092 o44 230 ・ ・ S No l lmport ltem つ 一 4 く つ 000 . 6 2ツ0 090 一 ′
9.F* 32t F. No.3501 1/24612015-PI (Norms) Government oflrdia Departnent of Pharmaceuticals Udyog Bhawan,Ncw Dclhl Datcd thc', SCptClllbCr 2015 01■cC MCmorttduln Sublcct― Fixalon of non1lS undCr para 4 7 ofttand BoOk Of ProcCdurcs(V011)2009-14 Casc of M/s llCtCro Labs Ltd datCd」よ Cお )::サiξTttξ lli:『1島‖ 11:li[11:灘‖ 111l1lil羊ilも轍』 i W:1器][P[踏盤よ求肌楷 lよ闘譜11 Procedures (Vol.l) 2009- I 4:- qu“ 甲 (3alnali Kllastgiう Udcr SCCは町OmeCoT朧 螺 肥 〕 Directorate Ceneral of Foreign Trade, (Shri M.V. Singh, FTDO). Udyog Bhawal New Delhi lmport Item L-Valine Methanol Qty. Recomnrended kg/kg' S No 0708 1 428 , 0856 」 4-Bromo MCthy卜2‐CyanO Biphcnyl DimctりFormamidc soditlln AzidC IDiisopropyl Ethcr 1 88 4 093 5 231 6
F. No.350l l/22612015-Pl (Norms) Govemment of India Ministry of Clrernicals & Fertilizers Departlrrent of Pharmaceuticals Udyog Bhawan Ncw DclhL Datcd thcつ`, SCptCn,bCr 2015 01■cc Mcnlorandum SulC∝‐ ::襦lξと」Tttl席ピ艦留譜 B°° kdR°CcmEs Ⅳ dl)200%14C、c Thc undcrsigncd is dilCctcd to rctr to DGFT U O No 01/82/50/1486/AM-15/1)ES― 3/1369 datcd thc 10/03/15 vidcヽvhiCh application'Om Nf/S C C ChClnicals&PhaHlla Pvt Lは 1 淵繊1獣11部幣∬#鮮鮮淵i構漱哺 l 14: ino Pcnlcinallic Acid(6‐ APA) jP-flyaro*y Pt "uYt ClYcine Base GM霧ゝ un“r,c― tOthCCOf器鶏職3 Directorate Geneml of Foreign Trade, rstui M.v. Si!8h, FTDO), Impoll ltCm 0568 04687
9///"" ?A _..-..-- Govemment of lndia Sublect: Advance Authonza10n application from NVs AminettPlasucizers Ltd forthe import of raw matenal againstthe eXport Of N‐ Methyl Mo"ho‖ Ine Oxide‐ 50% lAdvance AuthOlzation No 0310791849 dated 9 12 2014) Ref: UO No 01′ 82′050/01319′ AM‐ 15 dated 8 01 2015 M/s AmineS Plasticizers Ltd have subm tted present applcation fo「the import of raw matenal againstthe export Of N― MethyI MOrphollne Oメld●50% The app,catiOn has been exam ned and the Department recommends the following non ns forthe present Advance AuthOnzation appliCation Morpholine N‐Methyl MO「pholine Oxide-50% This issues with the approval of competent authority 蟻 (A K AGARWAL) AddL Industrial AdviSe「 ゃdゞ■●2“ 5
9バヽ.ア2` 一 F No350H′ 24572015‐PI oornls) Govcrnmcnt oflndia Ministly ol' Chemicals & Fertilizets Depa11ment of Pharntaceuticals Udyog Bhawan,New Delhi. Dated the ?, Scptenrber'. 2015 Ofllce Menorarldunl
Subject: - Fixation ol not-trrs under para 4.7 ofHand Book ol Procedures (Vol l) 2009-14 Casc
of M/s Honotrr Lab Ltd. The unclersignec{ is direclecl to rcter to DCFT U.O.No. 01/82/50/1287/AM- 15/DES-i/47 datcd th(] l2105/15 vide rvhich application from M/s. Hotlour Lab Ltd u'as sent to this Departnrenl fbr fixation ol'nomls Llndel pam: 4.7 for lhe export of Adenine' This depa(ment has exanined the matter and thc following llolms are fumished under para 4 7 of Hand Book of Procedures (Vol.l) 2009- I 4:- S No lnrpofi llenl Qty. ReconlNended kg/kg. 1 i\4rlononilrilc 095 2 Formamide 370 師ぃo中 (Bamali Klla,8ir) Undcr Sccretaty to the Covcmmcnt oflndia Phonc:23071162 Directoratc Ccncral of Forcign Tradc, Dcparlmcnt ofCommCrce, (Shri M V Singh,FTDO), Udyog Bha、vall,New Dclhi べ/
9 t/". 328 F. No.3501 l/73l2015-Pl (Norns) Governmenl oflndia Ministry ofChenricals & Fenilizels Department of Phamraceuticals Udyog Bhawan.Nerv Delhi. Dated the ,1 September.2015 Oftice Memorandum
Subject: - Fixation of nornrs under para 4.7 of Hafld Book of Procedures (Vol l) 2009-14 Case
of tvrs Alembic Pharma Ltd. The undersigned is directed to refer to DGFT U.ONo 0l /82/50/1468/AM- 15/DES- l/l199 dated rhe 26102115 vide which application from M/s. Alembic Pharn'u l'td was sent to this Department for fixatioD ofnorms nder para: 4.7 for the export ofAlemPlint xnd Pactum Injection. This department has examined the matter and the tbllowing nonns are lurnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S. No. lDlpoft Itenl Qty. Recommended. 1 4.942gm/vial Dircctorate General of Foreign Trade. Ihct"a{qra (Bamali KhastEi, Under Secretary to the Government oflndia Phone:23071162
9/^/・ F29 F. No.3501 1/76201 5-Pl (Norms) Government oflndia Ministry ofChemicals & FErtilizers Departnlent of Pharmaceuticals UdYog 13hawan.New Delhi. Dated the l\ September.20l5 Olfice Menorandurr
Subject: - FixatioD of no[lns under para 4.7 of Hand Book of Prccedules (Vol'l) 2009- I4 Case
of M/s Cadila Healthcare Ltd. The undersignecl is directed to rcfer to DGIT U.O.No 0l /82/50/ 1482/AM- I s/DES- l/l194 datect thc 26102/15 vide which application t'rom M/s. Cadila Healthcare Lld was scnl lo this DepartDrerl fbr fixation of norms undet Para: 4.7 for the expof of litodolnc l]rtcndcd Release Tablets 400mg,500mg and 600mg This department has exanlined the nlatter and the tbllowing norms are lurnished undel para 4.7 ofHand Book ofProcedutes (vol-l) 2009-l4i- S No Import Item For Export of I Million lablets. 41)Om9 500m■ 600 mq 1 Lactose Monohydrate 35 5 kg 44 375 kg 86850k8 つ 一 Magnesiun Stearate 175 21 875 26250 D 7‐ Eulyl TryptoPh01(76%) 386376 482970 579564 4 Methyl-3-Oxo Valerate 220320 27540 330480 5 Packing Materials Relevant. As per packing PolicY. 甲ぶsa～,ス (3arnali Khastgir) Undcr Sccretan tO thC COvcmment oflndia Phonc:23071162 Dilectoratc Ccneral ofForcign Tradc, Dcparllllcnt ofcommcrcc. (Shi M V Singh,FTDO), Udyog Bha■an,Ncw Dclhi
Otllce Menotandunr Subject: - Fr\atiorr of nont,. und". poro I 7 -Hand Book of ProcedLlres (Vol'l) 2009_l l Case of M/s Virrrpaksha OrPnnics Lld. hc mO乳i蹴鼎鳳網 総1濡たヽ田 籠、atiol1 0r 11。111lS tl!ldC「 Pala: 4 7 for the e、po■ol :;11:般1」↓ ill:Thtll椰1li」ll?aξ」〔 1lRI^^^ ,′ Directoratc Cencra1 0f Foreign Trade, 磁蝋∬紺樵 i 91 ,tc 338 F. No.i50l l/271l2015-PI (No ns) Covernment oflndia Mirristry of Chemicals & Fertilizers Department of Phannaceu!ica ls 1縫:秘話|'o苗md BooにOFPIocedures Cd D 2009J4 Udyog Bhawar,New Delhi. Dated the cl Septemb€r,2015 (BarnaH Khastgir) Undc「Secretary tO thC Gov;‖ :1:|」」 1;||:] Import ltelll Qty. Reconnrerded k8/kg. S No 049 | 1.3 Difluoro Benzerrc Di Chloro Methane 297
F No 35011/179/2015‐PI oorms) Govcrnlllcllt Of lndia DePa(ment of Phalmaceuticals UdYog Bhawan.New Delhi' Dated the l,1 Seplenrber. 2015 Office Memorandum Subiect: - Fixation of notms under pam 4.7 of Hand Book of Procedures (Vol l) 2009-l4 Case of M/s Virupaksha organics Ltc{. The uDdersigned is directed to refer to DCFT U O No 0l/82/50/18/AM-16/DES-I/414 daled the 07/07/15 ;ide rvhich application lrom M/s ViruPaksha Organics Ltd \r'as s(]nl to this Department for tixatiol1 ofnorirs r'rnder para: 4.7 fol the expo[ ofSofosbuvir' This depa(n1cnt ll*'"*urlin"a tl" *uttel alri the followirrg noflDs are fumished under para 4'7 of fland BooL of Procedures (Vol.l) 2009- I 4:- G鮨:鰤 Undcr SCCrctary to thc CoVCrnmcnt ofindia Pllonc:23071162 Dircctoratc CCnera1 0fForcign Trade, Dcparlmcllt ofCOllllncrcc, (Shi M V Singh,FTDO)、 Udyog Bllanall,New De皿 Imporl ltcnl -Deoxy-2-FIuor o-2-Methyluridinc _【S)‐ (2,3.4,5.6- 拶 Pノ″・′び Qty. Recommended k8/k8 090 192 S No 1 2 ‐Mctlylcth51 Ester
4ヾし F. No.i50l l/250/2015-PI (NornN) Covcm[rer1t of lndia Ministrl of Chemicals & Feltilizers glnt 7W Udyog Bhawan.Neu Delhi. . Dated lhe e S Octobcr. 2015 Olllce Memorandum Subiecti - Fixation oi nomrs under para 4.7 of Hand Book of I'rccedures (Vol.l) 2009- 14 Case of M/s Hetero Drugs Ltd. . re uDdcrsigned is dirccted to reler lo DGFT U.O.No. 0l/82/50/l i20/AM- I j/Dl'ls-3/'{2 dated the l2l05/15 vicie rvhich application lionl M/s- lletcto l)fttgs Lld was scnt 1() this Departirent for fixatiou ol nomls tlnder para: 4 7 for the exporl of Morifloxacin Hydrochlorirle. This department has exanrincd ihe mattel and the loilorving nornls irc furnished under para 4.7 ol t land Book of Procedures (Vol.l) 2009- 14:- Note:- DGFT is advised to revise SION A-3520 by calling All Industry Production- diis-tutption data dr.rly certified by Central Excise Authorities through Pharmaexil. r颯しの搬´ OalnZall KInast」う Under Sccrctary to thc Covcmmcnt ofindia PhOne:23071162 Dircctoratc Ccneral of Forcign Trade, Dcpallmcnt ofCommcrcc, (Shn M V SulgL HDO), Udyog Bhawall,New Dclhi S No lmpo( ltem Qty. Recon rended kdkg. l Ethyl-1 -Cyclopropyl-6,7-Difl uo-1,4-Dihydro-8- Methoxy-4-Oxoquinolioe-3-Carboxylate 0978 2 (S,S)‐ 2,8‐ Diazobicyclo(4,3,0)Nonanc 037
ド18h~｀6 No 46011′113/2009-PC ll Gove「nment oflnd a Dep酬1:W』i累淵断 :S∫層電瀧ヽ cJs Room No 223,A Wing, Shastl Bhawan,New Delh卜110001 Dated the 」uly 23, 2015 0FF:CE MEMORANDUM Sub::識::1:盤&」量濡紺 =も順 ∬ =111肥 岬冒群よ ::i鮮 Orthoxylene and corresponding imp●rt― reg fo‖owing basis i― This has approval of the competent authority' ジィ稔y、 (O P Sharma) 」。int lndustrial AdviSer Tel:011‐ 23071442 Telefaxi 011-23071187 Ema■OmSharmaOnにln 響 :1蛸ll齢椰消}幣n, Fax1 2306 2225/23061613 Name of imPort Name of ExPort CIF value‖ mited to 0 90% of FOB value ofilPgl! ne _-tevant cataYst and chemicals used I n manufac!!lg-.1{!4!9lyl9!9
9/Ah. 3\ No.46011/113/2009 Government of lndia Ministrv of Chemicals & Fertilizers Departmeniof Chemlcals & Petrochemicals Room No 223,A｀″in9, shag面Bh誂 ]舅W器 htrち:% OFFICE MEMORANDUM Sub: :‖ II]嗜ili‖Ii‖億 ::i緞憎:畷∬ =Iil測り 8::1魔T」i::i鮮 mport― reg fo‖oWing baSiS:― This has approval of the competent authority' :1鰤躁瞥静珊 }畔胃 :q Fax:23062225/23061613 -.// {r.katll LU"'.-. ' (O.P. Sharma) Joint lndustrial Adviser 'lel. O11-23071442 Telefax: 011-23071187 Email: 9!tsharma@nic in Name of imPort 1 2565 MT CIF value lmited t0 0 90% of FOB value of e RelevantE6talYst and Chemicals used ln manufacture of
マノノヽ /。. `ユt′ S No 46011′ 113′ 2009‐ PC II Government oflndia Ministry of Chemicals&Ferti‖ zers Department of ChemiCals&Petrochemicals 、0ウ Room No 223,A Wing, Shastri Bhawan,New Delhil10 001 Dated the 」uly 23, 2015 OFFiCE MEMORANDUM 詢瞬 欄 攪 撒 懸 胎 辟 ∬皿 宝出囲 群 鼎 瀾 ■port― reg fo‖oWing baSiS i― This has apprOVal ofthe compe 」。int lndustrial Adviser Te1 011‐23071442 Telefax:011-23071487 Ema‖ i OmSharma@雨c in :1鰤ll暴椰消}鼈L, Fax:23062225′23064613 Name of import Name of Export CtF value nmted to 0 90% of FOB value oI RelevantCatayst and 91eT Cas used ln manufacture of O
s / ^h '?++- ql` ′ うЧ} F. No.3501 l/i09/20 1 5-PI (Noms) Government oflndia Ministry olChemicals & Fertilizels Deparlment of Pharmaceuticals Udyog Bhawan,New Delhi, Dated the c8 Octobcr', 201 5 Oftice Memorandurn
Subject: - l'ixation ol'nonns under para 4.7 of Hand Book of Plocedulcs (Vol.l)
2009-14 Casc olM/s Jodas Expoirr Pvt Ltd. The undersigncd is directed to refer to DGFI'U.O.No. 0l /82/50/1162/,4M- l5/DES-3/ll7 dated rhe l6106/i5 vide which application fiom M/s. Jodas Expoim Pvt Ltd was sent to this Department ldr fixation of norns undet para: 4.7 lbr the export ofNovatrizoate 60%o Injection. This department has exantined tlre mattel'and it is requested that DGFT may call copy o[DML from the firm for the above expofi products a)ongwith calculation sheet. fkq,,a.fq.^ lBarnali Khistgir) Phone:23071 I 62 Department of Commcrce,
.- t /J^ 1(t '1 \ 1^1- I tr F. No.l50 I I /248/201 5-PI (Norms) Government of India lvliristry ofChenricals & l-e ilizels Dcpafi ment of Pltafi lacculicals Ud)og Blrau:lrl.NY$ Dcllli. l)ated lhc c d S<etee+b+r. l0li ('i't1t< ' Office Memorandum
Subject: - Fixation of non s under para 4.7 of Hand Book of Ptocedures (Vol.l) 2009- l4 Case
of M/s lletero Drugs Ltd. 1he uDdelsigned is directed to reter to DGFI U.O.No.0l/82/50/1i65/AM-15/DIIS-I/36 ddted the l2l05/15 viclc which application from M/s Hetero Drlgs Lid was scnt to tlris Departrlent ibr fixatioo oF rorms Ltnder PaIa: 4 7 lbr the expofl ol l)onepezil Hydrochloride- This clepartmelt has examjned the nutter and the following norms are lurnished under para 4'7 ofHand Book ofProcedures (Vol l) 2009-14:- Under Secretary to the Covernment oflndia Phone:23071162 Dircctoratc Ccncral ofForcign Tradc, Dcpatmcnt ofConlllllcrcc, (SM M V Singh,FTDO), U"Og Bhawan,Ncw Dclhi へ、 S No hnpon ltem Qty. Recornnended kg/kg. l 5,6 Din■cthoxy‐2(Py“ dinc 4‐ yI)‐MCthylenc indan‐ 1 0nc ＾ リ つ 一 (Baia‖ Khastこir)
ミ
F. No.3501 l/l 71l2015-PI (Norms)
Covemment oflndia
Ministry ofChemicals & Fenilizels
Departrne[t of Pharmaceuticals
夕″Lf夕l
Dttli」習γ
視憶器翻|:
omcc Memorandum
Subjcct:‐ Fixation of norms undcr pala 4 7 of Halld Book oF Proccdurcs(VoLD 2009‐
14 Casc
ofM′s HcrbochCm Ltd
The undersigned is dircctcd to rclcrtO DGFT U O No 01′ 82/5α 1366′ AM 15/DES 3′49
datcd thc 12705/15 vidc Which application ftom M/s
卜lCrbOChclln Ltd was scnt to thiS
驚撚[測胞
i篤夢
i路滋灘鼈
sl鶴謝
jぎⅧ篭
Diにctoratc Ccncral o「Folcign Tradc,
Dcpailnncnt of COm llCrcc
(Sllri M V Singh,FTDO)
Udyo8 BMWan,Ncw Dclhi
G」臨
挙
Undcr ScCrcttt tO thC Goverllmcllt oflndia
PhOne:23071162
lnlporl helr
|
9./+r' JrL F. No.'14010/ 39/201 1-CH-ll Government of lndia Ministry of Chemicals and Fertitizers Depariment of Chemicals and Petrochemicals Chemical Divasion Shastri Bhavan, New Delhi-110001 Dated: tt+r^September , 2015 To, M/s Deeoak Novochem Technologie Llmited' Office No. 305-307, 3'd Floor, Crtypoinl, Survey No. 17, Boat Club Road, P!ne, Ivlaharashtra, lndia-4'11001. Subjecl ADphcation from M/s lvl/s Deepak Novochem-Technologies Limited{or lhe import of raw- material against lhe expori of Tetla melhyl Blsphenol r ' Advance Authorization No - 31 10065235 dated 28 1 0 15 Sir, I am dhected io refer to your Advance Authorization application received from Offlce oi OCff * uiou" mentioned subjecl You are again being advised to submit the following informalion within '15 days ofthe issue of this letteri 1'Balancedchemicalreaclionsindicaiingthetheoreticalyieldandpracticalyield "L,r."iiilio ,in i"irtn icai l' stification and ;uthentic printed literature in support of the vield/raw materials applied for impo'l' i-* -;;i;;; ;i irlouction or etpon product ie' retra methvl Bispienol F and :;""tp;;J;; -n"irrnltio" of raw materi;ls in the vear 2a13'14 and 2014'20'15 dulv certined bY C A 3. Any other relevant informatlon Yours faithfu!lY, ?v,$*;at,< to.^. olonNo6' ' Addl. lnduslrial Adviser Tel. No 011-2338'1430 Cocf6: Shn. Mahender Vrkram Singh' FTDO (OES-4)' in reference to DGFT/UONo - -6iEi-roso,o ro, ou- I 6/DE s-3r44 dated 1 o' 8'20'1 5 υ
藉 F No35011/H4/2015-PI(Noms) Govcrnnlcnt oflndia Minsり。fchemtJs&Fcmh2CrS ' Dcpanmcnt of Phalll.accuticals ダ び UdYog Bhawar.Ncw Delhi' Dated the ol Septcnrbcr.20l5 Of'fice Menrorandutr
Subject: - Fixatior of nolms uncler para 4.7 ol Hand Book of I']rocedures (Vol l) 2009'l-1 Case
of M/s BDR Pllarma Ilternatiooal Pvt Ltd' Thc untlersigncd is (lirccted to retir to DGFT U.ONo 0l/82/50/1179/ANl'15/DES l/1243 dated the 03/-03/15 vidc which application lro M/s' BDR Pharrra lnlernalional Pvt Ltd was sent to this Dcpartnent for fixation of lrolms under para: 4 7 tbr the exporl ol'MeroDe[em l000mg and 500mg Podcr for Solution lor Injection' This depa nlent has exatrtined the ;;;r, :"J tt " tottJi,,g nomN arc fumished under parn 4 7 of Hand Book ol Proccdures (Vol.l) l00q- l4:- (Bl〔lil、a(1ませ ,0 Under SCCrett tO thC Govcrllmcnt oflndia PhOne:23071162 Dircctoratc Ccncra1 0f Foreign Tladc, Dcpa“ mcnt of Colllmcrcc, (Sllri M V Singh,F「DO) Udyog Bha、van,Ncw Dclhi S No 1 Ilrpoft ltelll Qty. Recommended. Meropcnen Trihydrate + Sodium Carbolate l255.0lmg/lg$ vial And 627.505mg/500mg vial
F No 350141490′ 2014-PI(Norms) Government ofindia ℃ :星猟濡 :Rli撃l::lf」::11:3ξ ゞ′ //●て ⊃ Shaslri Bhawan, New Delht the 9th February,2015 ofrce MemOrandum Su●e∝17攪∬∬脳臨:]き:1,黒鯉 d Hand BOOk d Procedures Ⅳ dり2009 )uticals Ltd brto DGFT U O Nos 01′ 82′50′570′AM― )2009-14: This issues with the approval oI Director (Pharma lndustry)' (Ral Kumar) under Secretary to the Covernment ofindia PhOne1 23071162 DirectOrate General of Foreign Trade, 障∬節朧il Quantity Recommended lmport Product 5938早gn:lァ :貨覧 tT‐ t 9,0■´ ciprof oxacin Hydrochloride USP ¨ ＾ ﹇ ） ） Ｎ ヽ,t_ s、ン
MiniStry of Chem cals and Fert‖ zers Department oF CheぃiCa s and Petrochemicals Subject Advance Authorization application from M/s sunshield Chemicals Ltd lor the import of raw material against the export of Octylated Di-Phenylamine (ODPA) Ref: U.O. No. o1/83/50/096/AM-16/DEs-lll/32 dated 18 3 2015 M/s. Sunshield chemicals Ltd. have submitted present application tor lhe import of .aw material against the export of Octylated Di-Phenylamine (ODPA) The aDolication has been examined and the Department recommends the following norms lor the present Advance Authorization application ∫ル_f`2_ Government of lndia This issues with the approval of competent authority' 体Kttr AddL Industr al AdviSe「 ン t092015 6ctylated Di-PhenYlamine (ODPA)
Case No.: |/8/82-ALC4,2014 Party Name:OPTIMUS Meel No/Date:8/82- St tui:
DRUCS PRIVATE LIMITED ALC420I4
approved
25.09.2014
HQ File
RLA File
Lic.No/Date:0910060915 Defer Datel
:01/82050/00665/AMl5/ :0924/M0/00100/AMl5/ 0409.2014
Docision : ln the light of ea rlier d€cision taken in meeting no. 2/82 dated 18.04.2013, it was decided to
ratify norms u.der Para 4.7 of HBP vl as per details Siven below or as applied by the firm, whichever r
less:
Export product
Exp.
Qtv
SI No
lmport items
Oty. alk
Rosuvastatin
Calcium
1k9
(4R-Cis) {-[(Acetyloxy) Methyl]-2,2-
o meth yl1 ,3-D ioxa ne-4-Acetic Acid-T 1-
Drmethvlelhyl Ester (DS)
187k 2 4 {4-Fluo.ophenyl)S-lsopropyl'2[(N-Melhyl N' Methylsulphonl)Amrnol Pyrimidine 5-YL- l,Iethanol (27) 1871k. RA concerned may iake furlher necessary act on as per above decision ol NC tt,‐
一
3つ
|
<tt.-y'-- gIBL _).- F. No.350l l/196/2015-Pl (Nonns) Covernment oflndia Departrrlent of Phannaceuticals Udyog Bhawan Ne! Delhi' Dated the ,jl SePterIbcr, 2015 Office Memorandunl Subject: - Fixation of no.r,. ,nd", pu,o 4-'7 of H"nd Book of Proceclures (Vol'l) 2009-11 Ca\e of M/s Aurobindo Pharn)a Ltd The undersignecl is clirected to reler to DGFT U'O'No 01l8?l5}ll492tAM-|51DES-]/9 | dalcd ,f," fflooils "iJ" ii"h aPplication frcm M/s' Arrobindo Pharora Ltl was sent to this DePaIlnrerlt tor ilii"" "f ""..t unclel para: 4.7 for the e\Port ol Zklovudint' Tllrs deParlnent.h'rs exanlined the ,,,"i", ,,',a ,f," f"ff.*irg rrolrns are lirrnished under para 4 7 ol Harrd Book of ProceJLtrcs (Vol l) 2009 l4:' r(\Cr"a.ai+ (Barnali KhasteirJ Phone:2]07t 162 Dhectorate Genelal of Foreign Trade, (Shri M.V. Sineh, FTDO), .rrityl-Z.i-e.,rtryd.ottryn, ia inc As per Fuel Policy. lmporl liern QッRccomnlended kykg 0 100 237 ´ ０ ， ル
クル′
■ (,stヽo■3′ /82 AI(1′
2014 Pari、Nano(ADILA ,可●●[No′ Datc ti′ S2- Siatus:
LALTHCARE LTD ,ヽLCl′2011 Appr。
、。d
l]|12()ヽ
H(,Fl● RI A Fl●
た。N。lDni●OS{,1]]7,O Del●rD,il
l,パ270,0′ o040,′ AM lil {)8′211010′001も
'′
ハM15′ 2,(,7201:
Decision : i t1le lig,l or ear iel decisio l taken ill illeet ,gI,o 16′
82 dated 16 08 2012 it
was dedded to rati nOrms under P"a47 of HBP vi as ptt deta‖
s given below or as
nP,icd by llle 6 rnl 、
vlichever is tess〕
QIV
SI No
Tamsu osin HcI
04m9
Capsule
,No
Tahs! osin Hydrochloride
0 403 mq
2
Methacryl c Acid Copolymer
170 012 mg
3
lllic,ocwsta‖ ne Celulose lA_icel
PH 102)
233m9
4
lmporttems at SI No 41o 10
RA may lake appropriate action d per rhe deision ofNorms Commiltee.
響1-■ rt N o 'i'fu F. No.350l l/419,2015-PI (Noros) Govemment oflndia Ministry ofChemical & Fertilizers Udyog tlhrrvan. New Delhi. the l3 October. 2015 Office Memoraldrrrr
Subject: - Fixatiorl olDornrs under para 4.7 ofHand Book of Procedures (Vol.l) 2009-l,l (iase
of M/s Aarti l)rugs Ltd. The undersignecl is directed lo lefer to DGFT U.O.No. 0l/82/50/ I 5l6/AM- I s/l)ES- l/245 dated the i0/06/li vide which application fronr M/s. Aa[i Drugs Ltd was sent 10 this Departnent for lixation ol nornls under pam: 4.7 for the cxpon of Clopidoglcl llisulphate USP. This depaltmeut has exanrined the rnatter and the li)llolving nornrs arc nlmished under
para 4.7 ofHand Book ot l)roccdules (Vol.l) 2009-l4:-
(Bamali Khastgir) Under Secrelary to the Government oflndia Phone:23071162 Directolate General of Foreign Trade, Department of Commerce. (Shri M.V. Singh, FTDO). Udyog Bhawan, New Dell S. No. Inrpoft Itelr l. 2-Clrlorophelyl Clycine 1.05 . つ Melharol ● Ioluene 1.36 4 Methylene Dichloride 1.82 L-(+)-Tal.taric Acid 0700 ´ ０ Acetone 2.36 7. 2-Thiophere Ethanol 0707 8 Activaled Carbor 0039
F. No.350l 1/23612015-PI (Nonns) Govemment of India Depanment of Pharmaceuticals Ud)og Bhawan.Nclv I)elhi. Dated the c'( october.20li Oftice Memoranduur
Subject: - Fixatior ol norns under pam 4.7 ol Hand llook ol Procedures (Vot.l) 200q-14 Casc
of M/s Hetcro Drugs Lld. 'fhe urcler.signed is dirccted to reter to DCFT tI.O.No.0l/82/50/1538/AM l5/DliS-l/78 daled the 16/06/15 vidc rvhich application liom Nl,'s. llctero Dnrgs Ltd was scll to lhis Depafiment fol fixation ol noLnts under para: 4.7 fin lhe exporl of 2,3,4,5-Bis-O-( l - Methylethylidene)-P-D-lirurt0pyranose. This department has exanrined the matler and it is rcquested that DCFT may call tbllowing tech cal details tionr thc tinD viz:- {dr fld-usc ol rlrr exforl prodc l. (b) Conplete technical dctail as per Appendix-i3 showing %o yield ol1 nolcr l'rasis and Solvent Recolcly. (c) Copy oftechnical litemture in supporl ofyield envisaged. (d) Past producliorr vis'ar-vis Actual consumptiorl of imponed input dull' certiticd h1, Cenrral Excise Authorities. G鼎驚浩ξ肝 Under Secretary to the Government of India Phone:23071162 D€partnent of Commerce. (Shri M.V. Siugh, FTDO).
F. No.3501 l/41 1/201 5-PI (Nomrs) Government oflndia Depannlent of Pharmaceuticals Udyog Bhawan.NCW Dcl11 Datcd thc'`I SCPtClllbCr 2015 枷bC∝ :品 '∫ λttllTξ盤::∬117MJP10dtllcヨ 慟め獅明4C‐ Thc tindcrsigncd iS dntctcd lo lclCr to DGFT U O No 01/82/50/1541′ AM― 15/DES― 3′ 249 dacd thc 01/07/15 vidcヽvhicil application fror・ l Iヽ4/s Arcnc Lilt・Scicnccs l)Vt it(1 、vas ilitilil暑lliliキ|lll!細 liじ ∵ぶl∫∬:1::」:r」醤群l:]キξl〔請::1:Ilり|:: 漁i器:Itti棚輝漢品|ビ麒 ::庶ぽ話嵐ill山“ m r,ィ9《こぇハルいヘ (Balnan Khastsir) Undcr ScCrctary to thc Covcmmcnl oFIndia PhOnc123071162 Dircctoratc Cencral ofForcign Tradc, Depallmcnt of COmmcrcc (Shri M V Singh,FTDO), Import ltCm Thymidinc l -4-DioxaDe 3676 2836 Sulfoxidc
ジ / F No350H/231/2015 PI(Norms) Govcmmcllt ofindia M乱〕島彙器 :諄織ポ」 []l脂:rs , Udyog Bhawan Ncw Dclhi Datcd thC C I SeptCllnbcr 2015 Su●C∝屏翌 ,ξl基ピ il:よ[『 pf削ず聟蹴識畿。 f PЮ ccdurcs α d l)2009 1l Casc lllc undcrsigncd is dircctcd to rcたlto DGFi t'O No 01/82/50/1542/AM-15′ DFS-3/92 datcd tilc 16′ 06′ 15 vidC ヽVhiCh appliCation flopl ヽ4/s Hctcro Labs ltd ヽヽas sCl]t t()tllis 榊貰 l響熙‖ j繊朧#li掛il鶴[辟鮮∬淋樵 おHowing tcchnical dctails tloni thc lllnl ViZ‐ (a)End―usC Of t1lc cxport product (b)JuStiflcatiol〕 lbr loヽv yicld Or 39 3% in stcp II stlppOrtcd by COpy of tCCllllical litcraturc (C)PrOduction in 2013‐ 14 vis― a_vis Actual consumptiOn of an illlPollcd inPttts dttly ccrtiflcd by Ccntral Excisc AuthoriticS (Bamah Khastgi0 Undcr SCCretary to thC Covcrllncnt Of lndia PhOnc123071162 Dircctoratc Cellcral ofForcign Tradc, Dcpalllncnt of COtl■lcrcc, (Sbi M V Singh,FTDO), Udyog Bhawan,New Dclhi
]7() , , S/・ ′81′´ ‐ Case No:'7′ 10782‐ ALC4′2013 Pary Name cADlLA MCet No/Date 10′ 82‐ Status:Case HEALTHCARE LTD ALC12013 Approved 22082013 Ho Fne RLA File Lic No/Date 0810121694 DeFer Date :01782′ 050′ 00280'AM14′ :08′ 247040′ 00087′ Aヽイ14′ 04062013 D€cisiot : ln lhe light ofearlier decision takcn in meeting no i/82 dated 2'J 20-13, it w's decid€d to raliry RA nl″ ●kC appropriate actionぉperthe decision OfNoms Committee der Paro 4 7 of HBP vi as derails siven bel )w or as applied by lh€ firm, whichever S No Nornrs Recommended fbr I No. Divalproe、 Sodium 125 me Spl・nkle CaDStlle Di!alproer Sodium DE l?5 'ng DR Tablel Divalproer Sodi m DE 250 mg DR Tabhr Divalproex Sodiun Df, 500 mg DR Tablel | Divalproex Sodium :31625■,q 134 625 mq 269 25 mg 538 50 1ng Hypenrellose 3 CPS 12688111ス Melhyacrylic Acid Coooly Disp€rsron 56.89 nrg 43.8475 mg 800mg 160 0 ng | Microcrystalline Ccllulose Sphercs 89 667 ng 5 TriethvlCitrate 5 583 nlЧ |ヽ0 1nt : 40 nrs 4 801η R 6 Povidone K 30 ,50 mq 190n19 380 mq , M icroc!,stalHne Cellu ose(Avicel PH 101) 52 94 mg 105 87 ng 211 75 ng S Magneslum Steamte 237 mq 475m8 950 mg 9 19 Botlles and Caps Relevanl. as Der packi q Policy
Qい■ m“ ■c●ヽ 勝 つ05 oFrlcc Mclllorandunぅ SulCCt― Fixation o「norlnns undcr pa"1 4 7 of Hand Book of P10ccdurcs(Vol l1 2009‐ 14 Casc ofヽ4/sSヽイS PhallHa Ltd Tlぅc undcrsigncd is dircctcd to l℃fcrto DGFT U O No 01/82/50/1549/AM-15/DES‐ 3/129 datcd thc 16/06/15 vidc which application flolll Nl′ s SMS Pharma Ltd、vas selit to tl,is Dcpartll cnt ror ixati。:l of norllns tll,dcr para: 4 7 fol tllc cxPOrt of Lcvctiracetam T1li、 dcpartmcnt has cxamincd thc mattcr alld tllc lo1lo、 ving ilorlns arc ftlrnishcd undcr pala 4 7 ol Hand Book of Proccdurcs(Vo11)200914■ !. No.i50l l/26U2015-PI (Norms) Covemlrlent oflndia Ministry of Chernicals & Fel.lilizers Depa rlent of Phamaceuticals g″ノ f1ilq/a4t?u (Barnirli KhxslPir) Under Secretary to the Covemnlent oflndia Phone123071l62 S No Inrport ltenl Qty. Recommcnded kg/kg. 1 (S)+2 Amino Butyramide Hcl 095 つ Metlrvlene Chloride 252 Dircctoratc Ccncral of rOrcign Tradc, Departmcnl orCommcrcc, (Shri M V Singh,FTDO), Udyog Bhawan,Ncw Dcli
タメⅢ.マ9ノ F No電 :|:‖驚 :∫lif:ぶ° rm9 Ministry ofChemicals & Fe(ilizers Udyog Bhawan.New Delhi, Dated the October' 2015 Office Metnorandum Subjecl: - Fixation of norms under para 4.7 of Hand Book of Procedures (vol l) 2009-14 Case of M/s Dhanuka Labs Ltd The undersigned is directed to refer to DCFT U.O.No 0l /82/50/446/AM- 16/DES-3/494 dared the 08/07/livide wlrich application ftom M/s. Dhanuka Labs Ltd was sent to this Depa(ment for fixation of norms under para: 4 7 for the export of Cefdinir USP/BP'{P/EP' This department has examined the matler and the following norrns are fumished under para 4 7 of Harrd Book ofProcedures (Vol.l) 2009-l4i (3arnali Khastgir) Ulldcr Secrctary to thc Govemmcnt oflndia PhOne:23071162 UdyoB Bhawan, New Delhi S No Irrpor-t ltem | 7-Pll-*ylu"etamid.o-3-ChlorometlrylCephalosporarric Acid Pam Methoxy Benzyl Ester (GCLE) 2263 2 Triphenyl Phosphine 1 234 D Sodium lodide 011 4 Phenol 242 ) Vethvlene Chloride 12556 ´ ０ Ietra Hydro Furan 2425 7 Methanol 4414 8 Formaldchydc 274 9 ( acm 1 397 10 Triethylamine 0:55 11 r-Butyl Acetate 1 659
F No350H′ 19a2015P1001m9 GoVernment oFIndia M8::猟 Rl∫l:‖i]漁[il鵬` Dalyl‖:ゞ h驚 ]ボlま璃 |: 出需器酬愕R。∝“ FS Cdり200)口い●ご Mム SubC∝‐ 1〕l::lボ出 I‖lガ誦lpa.47 ofHm 2009‐ 14:― Directorate Ceneral of Foreign Tmde, Departnrent of Commelle' (Shri M.V. Sirgh, FTDO). Udyog Bhawan. New Delhi ゆ “ ぅ椰 ハ (BarnaいKhastg r) 伽“ rS∝retaり0●eC∝;躙鶏l権 002 1!0 0098 S No lmport ltenr N-Hydroxy-2-PYridinone N,N-DicyclohexYl Carbodimide Activated Ca6on Bromochlorotnethane Di Methyl Formamide lso PrcpylAlcohol Iso Ouinoline{3S)-Carboximide t- lL-Phenvlalanine I IL-(+)-Asparagile MonohYdrarc I lMethane sulphonic Acid I lMethanol I lMethylene Chloride [N-Hydroxy Succirimide [Tetrahydrof,ran lToluene lTri Melhyl Chlorosilane 1 ２ 一 ■ 1 11 4 1 256 ) 2008 6 7 0ヽりも 115 8 042 9 0338 10 0909 11 2334 12 0344 13 3370. 14 0663 15 0770 ´ ０
s,b)f F. No.l50l I/241l2015-Pl (Norms) Covernment of l0dia DePartment of Pharmaceuticals tldyog Bhawan,New Delhi, Dated the September, 2015 Office Memorandum subrecr: _ Fixation of rro.,n, unde, pi.a 4-of Hand Book of Procedures (vol.l) 2009- l4 casc ol M's Malrarchi PharmJ Chcm Pvl Lld' The unde$igned is directed to refer to DCFT U'o'No 0l/82/50/159/AM-16/DES-]/Il4 a^tea tfr.'iolo.67ii iiae which application from M/s Maharshi Pharma Chem Pvt l'td was sent a'rf,li. bao^.**t for fixation of norms under para: 47 for the export of Mometasone i:rr""," im l.o"","ent has e\amined the matter and the following norms are furnished under para 4.7 of i-land Book ofProcedures (Vol l) 2009-l4:- ・ 一 〆 一 lmport Item S. No. 1. 16 AIPha MCthyl Epoxidc(8DM) 1.04 (Barnali Khastgir) Phone:23071162 Direclorate Ceneral of Foreign Trade. Depanmenl ofCommerce, (Ski M.V. Singh, FTDO),
〕担 ′89 covemment ofindia Dep酬‖ :ミ恐麒 撚霧翻躍鳥 itts St Sublecti Advance AuthOnza10n applca衝On`from M′ s CU」ARAT ORCANICS LTD forthe import Of raw matenal against the export of PROPYL PARABEN′ METHYL PARABEN′ PARA ANISiC ACID′PARA METHOXY BENZOIC ACID Rer u O No 01′ 82′050′ 00736′AM16′ DES‐ ‖′847 dated 31 08 2015 UO No 01/82′ 050′00920′ AM16′ DES― ‖ 1′882 dated 2 9 2045 00 No 01′ 82/050′00765′ AM16′ DES‐ ‖/724 dated 04 08 2015 Mtte2‖ ::]iよ7:ゝ蝋よ、 }[:。指 lil!|li[][通キ illli::1:II肯111[‖]|よli尊 795309 dated 15 04 2015)
- ltem of Export Qtv Item of lmpoft Qty PROPYL PARABEN l KG , P―HYDROXY BENZ01C AC:D 0 922 KG (AdvanceAuthorizationNo 031079531ldated10102014)
- ltem of Export Qtv Item of lmport Qty METHYL PARABEN l KG 1 P-HYDROXY BENZOIC ACID 1044 KG This issue wlth the approval of compelent authority. 縣 (A K ACARWAL) Add lndust百al Adv se「 Tel No 011‐ 23384430 vance Autho市zalon No 031079`o2里dated ,oゞ ■●lr
- ltem of Export Qty Item of lmport Qtv PARA ANlSIC ACID′PARA METHOXY BENZOIC ACID l KG l PHENOL 0 986 KG 2 POTASSIUM HYDROXlDE 0 900 KG )15 Q
(リ ~…71111 Advance AuthO門za‖ on applcalon from M′ S PJ Industttes Ltd Ltd forthe import of raw materal against the export of 2‐ methyl‐ 1‐ methy thio‐ 2‐ p「。Panamine (SAA) (Advance AuthO「izaton No 1310047841 dated 17 04 2015) e/.,4.,49 Subject: lvl/s. P.l lndustries Ltd. have submitted present application lor the import of raw material against the export of 2-methyl-1-methylthio-2-propanamine (SAA). The application have been examined and the Department recommends the following norms lor the present Advance Authorization application. '1. ltem of Expori Qtv Item of lmport Qty 2‐methy‐ 1-methy thlo― 2‐propananline(SAA) l k9 2-Am no‐2-Methy卜1-Propano(AMP) 0957K9 TOLUENE 0 248 Kg Shl Mahende「Vikram Sin●h FTDO (DES■い0/o DGFT Udvoo Bhawan New Delhi-11 Deptt Of C&PC u O No 15022/6/2010‐CHJl dated3o 9 2015 lA K AGttRWAL) AddL Industr al Adviser
シ F No 14010757′2015‐ CH‐ I Government oflnd a Min Stry Of Chemicals and Fert‖ ze「s Department of Chemica s and Petrochemicals Shast「1 8havan,New Delhi‐ 110001 0ated: 1、■Septembe「,2015 To. M′s Etemis Fine Chemicals Ltd, 1004,Peninsuia tcMer,10° Floo喘 Peninsula Corp park,G Kadam Marg, Lower Parel, Mumbal.Maharashtr卜400013 Subled:‐ Advance Auhorzatlon Appl●lon for the import of rattmatenals against the export of Para Tertiary ButyI Cyclohexyt Acetate― Super lAdvance AuthOn2atOn No 0310795394 dated 17 4 2015) l am di「ected to rerer to your Advance Autho「12at10n applcation ieceived through ofnce Of DGFT on the sublett menuoned above ln this connedbn,you are requested to submitthe fo‖ owing infornation within 15 days ofthe issue ofthis ietter '1. Detailed manufacturing process with balanced chemical reaclions indicatjng number of moles of all the reactants, products and by-products with corresponding motecular Formulae, structural formulae, molecular weight and process flow diagram. 2. Stage-wise percentage yield with respect of each of the reactants and proaucts and the relevant justification enclosing therewith authentic printed technical lilerature in support of yield or quantity of items lor import. 3. Details of byproducts formed during the process and their recovery in terms of quantity and value. 4. Details of production of export product under reference and corresponding consumption of raw material in the year 201;J--'14,2014-15 and 201S16 (Aprilto August)duly certified by CA may be furnished 5. Any other relevant information, if any. ノ。ユプ Addl lndustna AdViSer Tei No 011‐ 23381430 reference to DGFT′ U0 10082015 Sh“ Mahender V kram Singh,FTDO(DES-3),in No‐ 01′82′ 050′ 00757′ AM-16′ DES‐ ‖′747, dated (AK A●ARnrAビ)
)tu 9Qc) F. No.350l 1268/2015-Pl CNorms) Govemment oflndia Deparhnent of Pharmaceuticals Udyog BhawanNew Delhi, Dated the October. 2015 Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Plocedures (Vol.l) 2009-14 Case
ofM/s Nutra Specialities Pvt Ltd. The undersigned is directed lo refer to DCFT U.O.No. 0l /82/50/75lAM- 16/DES-3/ 17 dated the I l/06/15 vide which application from M/s. Nutra Specialities Pvt Ltd was sent to this Department for fixatiod of norms under para: 4.7 for the export of Sitagliptin Phosphoae (APIS/ Bulk Drugs). This department has examined the matter and it is requested that DGFT may call following technical details from the firm viz:- (a) Norms applied by the firm does not match with the yields given by the firm i.e. 90% X 90.05% X 9070 in 3 step reactions- Detailed calculations/justification may be furnished by the firm. (b) Past production vis-d-vis Actual consumplion of imported inputs duly certified by Cental Excise Authorities may be furnished in support oftheir claim. (Bamali Khastgir) Under Secretary to the Covemment oflndia Phone:23071 162
_9//・型 Government of lndia / Subject: M/s. P.l lndustries Ltd. have submitted present application for the import ol raw material against the export of 2-methyl-1-methytthio-2-propanamine (SM) Advance Authorization applicaiion from M/s. P.l lndustries Ltd. Ltd for the import of raw material againal the export of 2-methyl-1-methylthio-2-propanamine (SAA), aAdvance Authorization No. 13'10047841 dated 17.04.20'15). The application have been examined and the Department recommends the following norms for the present Advance Authorization application.
- ltem of Export Otv Item of lmport Qty 0 957 Kg 2-methyl‐ 1‐methylthio‐ 2‐propanamine(SAA) ` k9 2-Amino 2‐ Methy卜1-Propano(AMP) TOLUENE 0 248 Kg | This issues with the approval of competent authonty Addl lnduSnal Adv se「 Tel No 011-23384430 h FTDO(DESJI o,C&PCu O No 15022′ 6′2010-CH‐ l dated3つ02015 lAK ACAM麗いtゞ
ダ ノ。 1 Government of lndia ヌ´ l・ Subject: Refl Advance Authorization application from M/s. Yasho lndustries Pvt Ltd' for the import of raw materials against the exporl of Yapox CL 30/10 Hydroquinone BIS (2 Hydroxy ethyl ether) U.O. No. 01 /8ZO5O/1 2521 AM1 sIOES'llll 1222 dated 3.03.201 5 lvl/s. Yasho lndustries (P) Ltd has submitted present applications for the import of raw materials against the export of Yapox CL 3Oi '10 Hydroquinone BIS (2- Hydroxy ethylether) The application has been examined and the Department recommends lhe following norms forthe present Advance Authorization application.
- ltem of Export Qty Item of lmport Qty Yapox cL 30′ 10 Hyd「oquinone BIS(2‐Hydroxy ethyl ether) l kg
- Hydroquinone 061l Kg This issues with the approval of competent authority (A K ACARIAAL) Addl industr al Adviser TeL No 011‐ 23381430 Or c&Pc u o No 140111195′ 2011-CH■: dated, 42015
′||へ′ V｀‐16 F No 35011/2802015‐ PI oヾOrms) Govemmcnt ofindia Ministry orchenticals&FertHizcrs Dcparmcn1 0fPhal口laccuticals Я A/c И ι'可 一 UdYog Bhawan.Nerv Delhi. Daled the C' t October. 2015 Otllce Menrorandum
Subject: - !-ixatioi ofro|rns uDder pam 4.7 of Hancl Book oll'rocedures (Vol.l) 2009-l'l Casc
of M/s Varahr l)hilnrra Pvt l.td The undersigneri is directed to rclcr lo DCIT U.O.r"'o. 0l/82/50/402/AM- I 6lDES-i/2I 5 datcd the 29106/15 vi(le which applicatio[ tiot'n M/s. Varahi I'hatma Pvt Ltd was scrlt to this Depa neDt lbr fixation o l' nomrs under para: 4.7 tbr the export ofClopidogrel Bisulfatc This depafiment has exan ncd ltle matter and the lollorving norms arc lurnishcd under para 4 7 of I land Book of Procedures (Vol.l) 2009- 14:- S No Impoll Item Qty. Rccomnended kg/kg. DL-2-Chloro Phenyl Glycirre 99% Min 105 2 2-Thiophene Ethanol 0707 , し(+)Taltaric Acid 070 4 P T S Chlondc 1 05 fl*tcr"aa t5a,t lBamal i Khastgir) Under Secretary to the Govemment of India Phooe:23071162 Dircctoratc Cencml oF Forcign Tradc, Dcpaltmcnt of Commcrcc, (ShH｀ `V Sinま ,FTDO) Udyog Bhawan,Ncw Dcnli
） ´ 膊 UdYog Bharvan,t"-e$ Del h i. Dated the ),t SePtember.2015 Otlice Memorandutt
Subject: - Fixation of nonrs undet para 4.7 of Llald Book of Prccedures (Vol.l) 2009-l-l ( ase
of M/s Neuland Labs Ltd. The undersigned is dilectcd to reitr to DGIT U.O.r"o. 0l /82/50/686/AM - 16/DES-]/650 dated the 29107/15 vidc which application fronl M/s. Neuland [,abs Ltd was sent to this Depaftment 1br lixatioD of Dom]s ul'tder pata: 4 7 for the export of Ropinirole Hcl. This depaltment has examincd lhc matter and the following norms ar'e lilrnished uncler para'1.7 of Hald Book of Procedurcs (Vol.l) 2009- 14:- F. No.3501 l/215/2015-Pl (Noms) Govemment of lndia Ministry of Chenlicals & Fenilizers Depaftrert of Pharmaceuticals S. No. Inlpon Itcrn 1 4-(2-Bromoethyl)-3-Chloro- 1,3-Dihydro-2H-Indolin- 2-One 2232 , 50/O Palladium oll Calbon 0100 D Activated Carbou 0100 4 lsopropyl Alcohol 6.60 ). Methvlene Chloride H21 6. \4ethanol 2.32 t$u^o,nl1u (Bamali Khastgir) Under Secretary to the Govemment of India Phone:2i071162 Directorate Gereral of Foreign Trade, Department of Commerce.
9/4 +31 F. No.3501 l/415/201 5-PI (Norms) Covernme oflndia N4inistry of Chemicals & Fefl ilizers Depadment of Pharmaceuricals Udyog Bhawan,New Delhi, Daled the October, 2015 Ofllce Memorandum Slrbject: - Fixation of nomrs onder pam 4.7 of HaDd Book of Plocedures (Vol.l) 2009-14 Case of N4/s Polydrug Labs P!,1 Ltd. The undersigned is direcled lo ref-er to DGFT U.O.No. 0l l82l50l20glAM-16/DES-3/31 I daled the 02/07/15 vide which application trom M/s. PolydruS Labs Pvl Ltd was sent to this Depanmenl for tlxation ofnorms under para: 4.7 for the export ofMetoprolol Base. This depanment has examined the maner 6nd ihe fbllowing norms are tirrnished under para 4.7 of lland Book of Procedures (Vol.l) 2009- I4:- S No lnrJrorl Iterrl 1 4-Methoxy Ethyl Phenol 0665 う Epichlorohydr,n 052 , Methyl Isopropyl Amine 0509 (Barnali Khastgir) Under Secrelary to dre Covemment oflndia Phonei2307l162 (Shri M.v. Singh, FTDO),
ワイ・ク′≒弓角 lい~ No 46041′ 36/2012‐ PC‐ || Government oflndia Ministry of Chemicais&Ferti‖ zers Department of Chemicats&Petrochemicals Room No. 223, A Wing, Shastri Bhawan, New Delhi-110 001 Dated the October0l, 2015 OFFICE MEMORANDUM Sub : Application from M/s. Reliance lndustries Limited, Mumbai for issue of advance lic.nce (LicEnce No. 0310795868 daied 13.05.2015) for export of Methyl Teniary Butyl Ether (MIBE) and corresponding import - reg. The undersigned is directed lo refer to U.O. No. 0'l/82/0501007231AM- - 16/DES-lllr/08 dated 31.07.2015 from D.G.F.T on the subject cited above. The' proposal of the firm has been examined in this office. The Department of Chemicals & Petrochemicals recommends the present Advance Authorization Application on the following basis:- Name of Export Items (s) Qty in KG Name of mpOrt Lem(S) Qty in KG Methy:Tertiary Butyl Ether(MTBE) l Kg Naphtha 0951 iЛethanol 0361 This has approval of the competent authority. 巫鵠 」oint lndustrial Adviser Te 011‐23071442 Telefax:011-23074487 Ematt omsharrnaOnにm Shri Mahendra Vikram Sangh, Foreign Trade Developmenl Ofiicer, Oirectorate General of Foreign Trade, Ministry of Commerce and lndustry, Tel. No.23061562, Extn. 269 F ax: 23OO 2225 l23OO 1 61 3
1lQ File :01′ 82′050′ 00020/AM14′ :03′ 95′040′ 0018'′AMil′ 0'062010 Decision : In the light of carlicr dccision takcn in mceting no 13/82 datcd 28 6 2011,it 、vas dccidcd to rau″ normS undcr Pala 4 7 of HBP vl as pcr dctails givcn bclow or as the firm. rvhichever is less: Export product Exp Qty SI No lmport items otv. allowed Paraxylene `MT 1 Reformate 1 376 MT Relevant Catalyst and Chemicals used in the manufacture of Paraxylene CIF value limited to 0 90% FoB exoorts RA may take appropriate action as per the decision ofNorms Committee. Party to be advised to apply for fixation ofSION thrcugh EPC. RLA File 製
Case No:20′ 2′ 82‐ ALC4′ 2013 Pary Nane:RELIANCE Mecl No′
Date 2′ 82- StatusICase lNDUSTRIES I.TD AI C42013 Approved 18042013 L c No′Dtte 03105781 3 Defcr Date
F Department of Chem cals and Petrochemica s ShaSri Bhavan,NeW Delhl‐ 110001 oated: September 2015 To, lvl/s Eternis Fine Chemicals Ltd , 1004. Peninsula tower, 10f Floor, Peninsula Corp park, G. Kadam Marg, Lower Parel, N4umbai, N4aharashtra- 40001 3
Subject: - Advance Authorizaiion Application for the import of raw-materials againsl the
export of Cyclamen AIdehyde- Pure (Advance Authorization No. 0310795971 dated 18.52015) I am directed to refer to your Advance Authorizatioo application received through Office of DGFT on the subject menlioned above. ln this conneciion, you are requested to submil the following information within 15 days ofthe issue ofthis letter. 1 . Detailed manufacturing process with balanced chemical reactions indicating number of moles of all the reactants, products and by-producls with corresponding molecular FoImulae, structural formulae, molecular weight and process ,low diagram. 2. Stage-.wise percentage yield with respect of each of the reactants and products and the relevant justification enclosing therewith authentic printed technical literature in support ofyield or quantity of items for impo(. 3. Details of byproducts formed during the process and their recovery in terms of quantity and value. 4. Details of production of export product under reference and corresponding consumption of raw material in the year 201i}'14.201+15 and 201$'16 (Aprilto August) duly certifled by CA may be furnished. 5. Any other relevant information, if any. (A K ACARヽVAL Addl lndustrial AdviSer Tel No 011-23381430 llgEGr Shri. l\4ahender Vikram Singh , FTDO (DES-3), in reference to DGFT/UO No‐ 01′ 82/050′00769/AM‐ lαDESl‖ ″21,dated 4 08 2015 〃
Office Memorandum
Subject: - Fixation of norms unde, pu.a 4 7 of Hand Book of Procedures (Vol l)
2009-14 Case of M/s Mangalam Dlugs & Organics Ltd' The undersigned is directed to refet to DGFT U'O'No 0ll82l50l39llAM' l5/DES-3/880 dutJd the 03ll2tl4 vide which application from M/s' Mangalam O-gs A O.g"ni"t Ltd was 'sent to this Department for fixation of norms under p"#-+.2 foi,t" export of Lumefantrine This department has examined the matter and the following norns are fumished under para 4 7 of Hand Book of Procedures (Vol.l) 2009-1 4: 9 ^to' 4'? F. No.:sot ttooo/2014-PI (Norms) ' Government oflndia Ivliniitry of Chemical & Fertilizers New Delhi, tlre Udyog Bhawan, April,2015 S. No. Import ltem Qty. Recomrnended kg/kg. l. 2,7-Dichloro-A-(Dibutylamino) Methyl-9H- Fluorene-4-Methanol (DBA) 08691 ， ´ ,l-Chlorobcnzal DchYde 03476 2. This issues with the approval of Director (PI)' (Barnali Khastgir) Under Secretary to the Govemment ollndia Phone:23071162 Directorate General of Foreign Tlade, o
“ Dep酬計 :席』 l累熙富ifT霧認 :籍ヽ ca s Qty l tem of Ex20rt Qty 0 922 KG PROPYL PARABEN l KG ヽ (Advance Authonza薔。n No 031079531l dated10 10 2014) This issue with the approval of competent authority' AddI Industrial AdviSer 鈍中∝鸞獄‖熙|:撚熙朧糧髪聯l鶏躙 [ ′847 dated 31 08 2015 ′882 dated 2 9 2015 / item of I … lC ACID ^rr ^7o( ^ 1a.lata.l lc( f[ Lo (.f liem of lmoort Qty ヽ
- ltem of ExPo( Otv l PHENOL 0 986 KG 曜輸舗皇 NZOC ACID _ l KG o900 KG 2 POIAS●lυM HYDROXIDE o'C&PCu O ¨ aed599 2“ 5 Deptt
F No 15022′ 1742012‐ CH‐II Govemment ofindia DcP:II:7:lT:霊111∫∫繋 ::iicals 91 ShaStri Bhavan,New Deth■110001 pated:、6“ SeptelDber,2015 To. lvts. Bhasiradha Chemicals & lndusEies Ltd 8-2.269/5/l/A, Plotno. 3. Sagar Socity Road No'_2 Banjara hills' HYderabad- 500034 Subiect: Application MA Bhagiradha Chemicals & lndustries Ltd for the impon o{ raw-materials against the er.on of METHOXY A""rroii itur"r tE)-2- t2-(6- CHLOROPYRIMIDIN-4-YLoXY)- ptiENvt-l-:' uersoxvAcRYLAl L) (Advance Authorization No 0910062060 dated 22 08 2015) lamdirectedtorefertoyourAdvanceAuthorizationapplicationreceivedd[oughofficeofDGFTonlhe subject menlioned above r" rt'lt ti"'' V"" requestea io sutmit Ue following information wfthin l 5 davs oftbe issue ofthis letter. d manufacruring process, maErial balance wirh balanced chemical r€acrions indicating all the reactants and products #;;;;!';;;il ";;esponding molecular Formulae' strucrural iotruiot, lnattufit "tight and process flow diagram 2. Stase-wise percentuge vi"ta t'lit' t'spttt of eaci of rhe reactanrs and products and the relevant 'jusriucation 'nctos;ng 'r'""Ji'h ;li;;i;';;fu rechnicar literalure in luppon of )ierd or , 3:Tiiy"?t'r;:1,1'i"]?Ji[uu;"'""c€ssandrecoveryorsorvents intermsorquantitvand o. lli":L ", o.orction of expon producr under reference and-corresponding consumptioo of rdw material in the vear 2012'riiijri-l+ iiolq:ii auLv cenified bv cA mav be tumished lfrhe Droaluction has not comm"t"i i" ti" pt' trt" a""il' Loln "o"in"t"n' of production may be hurnished duly cenified bY cA 5 AnY other relevant information Yours faithtullY' ru4qPilra(,.- (A,K, AGARIVAL) ,.. Addl lndusEiai AdYiser , 'el'No 011-23381430 conv iby' Shri. Mahender Vikram Singh' FrDO (DES-3)' in reference !o DGFTTONo -0I/82/050/656/ AM-
tstogs'ttvl48' dared lo'8 2015
0ハカ9,チ -...J- Government of lndia Subjectr Advance Autho「zation applcation f「om M′s Yasho lndust「ies Pvt Ltd for the import of raw materia s against the exp● rt Of Yantq 2030B (25% Solution of Tertiary Buty HydrOquinone) lAdvance Author2atiOn No 0310792428 dated 29 12 2014) lAdvance Authorzation No 0310794375 dated 4 3 2015) Ref UO No 01/82′050′260.480′AV16′DESI‖′188,361 dated 29 6 2015 and 3 7 2015 M/s Yasho lndustnes(P)Ltd has subm ted present applcations for the import of raw mate市als against the export of Yantq 2030B (25% Solu‖ on of Tertiary Butyl Hydroquinone) The app‖ cation has been examined and the Department recommends the fo‖ owing norms forthe present Advance Authorization app‖cat on
- ltem of Export Qty Item of lmport Qty Yantq 20308 (25olo Solution of Tertiary Butyl Hydroquinone) l kg
- Hydroquinone 0352 K9
- Tertiary Butanol 0260 Kg
- Propylene clycol 0650 K9 (AK A;MAI; Addl lndustrial Adviser ／ ご 一 ． ． ・ 一 一 Deptt Of C&PC U O No 14010/95/2011 dated ヽヽ92015
SublCCt- 1lll:ult:::liよnder R/力 /。‐ t′ `` ′′ ― L/ゞζ F No 35011′ 407′2015-P10ヽOnns) Governmellt Oflndia MinistO OFChemiCals&Fertilizers Depaltment ofPharmaceulCals UdYog Bhawan,New Delhi' Dated lhe Oclober' 2015 Oflice Memorandunl paru +.7 of ttrnd e*k of Procedures (Vol-l) 2009-14 Case of M/s (BarnaH KhaStgio Under SCCrctaり10 thC COγ :lllよl」:;キ11: me w∬lЧ柑鳳:謂剛1嚇TRFTuONo08ν 5αttAMJσ Dいう 0“ ぬ“ d_Swit Labs Ltd was SCht to this Department for :鼎 e:需臀][l鵠W=λ 鳳よ淵 ξ器綿 damab9Юne mpЮ ●on■●ThS depanmem hぉ lrnished undcr para 4 7 of Hand Book Of P「Ocedures (v011)200914■ Directo.ate General of Foreign Trade' (ShriM.V. Sineh, PI DO)' iJdyog Bhawan, New Delhi I Onho ProPionate Qry. Recommended k8/kg. S No ImpoI1 ltem 083 Deuil not given. ,
“ す∫? 一 ― F No 35011/227/2015-PI(Norlals) Govcrnlllcnt of lndia Minist,Of Chcllnicals&FcrlHzcs Dcpaltlllcnt of PharmacCuticals Dat」flI:島]ll[:|:｀llも11: ♀ギF争¥景]轟き者ま1。f Proccdtlrcs(VOll)2009 14 Casc Sulは‐ :馴ξ 3∬濯 1じぱW留・° tl Dircctoratc CCncra1 0fForcign TradC, 弱麟熙淋 i ― mnlCndcd kノkg S No 1 80 1 1 80 つ
SubleCt:Advance Autho間zation appicalon from ViVimed LabS Ltd,for the import Of raw matena aga nstthe export Of Plalnum Grey(ReversaCOI Platinum Grey) Ref: U.O. No. O1/83/50/884/AM l4tOES-lVl122 dated 8 5 2015 ''" u.6. i'i;. oir&lsort gar$rt soes-tvrlo2e dated 20'03 2015 I Advance Authorization No' 0910058807 daled2''12014 ' ' Advance Authorization No 091005'1746 dated '14 03'201L vivimed Labs Ltd.,have submltted present applications for the import of raw material against the export of Platinum Grey (ReveBacol Platinum Grey)' ¨rmslli製Ⅷ蹴滉ξ訛詰 :酬::矧tttPe"・ m耐recommends the following … hytt nhydЮ NapthoD Dry P6trlum GreY (Reversacol Platinum Grey). St.lphOX deJDMH Tetra Hydro Furq4 AcelC Ac d This issues with the approval of competent authority 蟻 Addl l全1:ξ}:↑::‖::| O m Saqar Dept of C&PC UO No i7-otolt gazot l -cH-tt τatedゞ62045 p//.:′ た Government ofind a ∝p器需麒 撚殿1織itts 一 ィ ／ ／ ・ 、 一 ／ ／ ′ ／ ′ ｉ ‐ ‐ ヽ ヽ ヽ
m― “ タ ロ ′ Ｌ η し r.生 Government of lndia Sublect: Advance Authorzation app‖ calon from M′s TRANSPEK INDuSTRY Ltd forthe import ofraw matenal againstthe export of OCTANOYL CHLORIDE (Advance Authorization No 3410041263 dated 1 6 2015) Ref: UO No 01′ 82/050′706/AM16′DES‐ 1‖/644 dated 29 7 2015 TRANSPEK lNDuSTRY Ltd have submitted present app‖ cation for the import of raw matenalaga nstthe exportof OCTANOYL CHしOR:DE The applcation has been examined and the Department recommends the fo‖ owing norms for the present Advance Authorzat on applcat on Addl Tel No industttal Adv ser 011‐2331430
- ltem of Export Qtv Itern of lmDori Qtv OCTANOYL CHLORIDE ` kg l CAPRYLlC ACID 0 924 kg Deptt Vi Or c&Pc UO No 14010/6/2011‐ CHl dated ζ 10 2015 体K蒻
9t lto f )8 F No 35011′ 490′2014-PI(Norms) Government ofind a y:鷹γ ttRli撃1:1講」 ::11:昴ξ New De ht Office Memorandum Shastri Bhawan, the gth February, 2015 SuЦe∝17規∬♂謂y臨:]湯:『l烏鯉 d Hand B°° kびProceducs Nd0 200∝ )uticals Ltd 15′ DE!13′650 ][僣lelhξ llij;;14 %i:iPr t° DGFT U O Nos 01782′ 507570′ AM‐ Pharmaceuticals IJdヽvas SenttO thiS Dep:rt滞:おt。 「 llよ∫:‖讐:lltts11'er p:層:サ|; ユ擬 1罷∬藍 『 1柵 蝋 縦 器 調 器 :電記器品 詰 |)2009-14 ~1に cipronoxacin HydrOChloride USP Quantity Recommended １ ０ Ｓ Ｎ 冨餡 4 2 This issues with the approval of Director (Pharma lndustry)' 人つ , くヽソ (Ral Kumar) UnderSecretarytOtheGl営 ::‖::〕::;鴨: D rectOrate Cenera1 0f Foreign T「ade, 障∬騨朧ii
F No 14010/71′2014‐CH‐ ‖ GoVernment oflndia Dep辮:Ⅳ∫鱚 霧」鳥ユ i酬S '"5:H1"',&-3yr3"I"',1:3?l To' M/s salva chemicals Ltd'' 7/10. Botawala Building' Ground Floor, Bank Street' --^ Mumbai, ['laharashtra- 40uuzJ s,bit 'ASl;:;""lll6l?if,l fi:il;i+:li:J$,1,'[H1,3!3':-materiars asainst the (Advance Authorization No' 03'10796432 dated 4 6 2015) I am directed to refer ro vour AdJalce j'[ili.":::"TJ,[::!x1"":i'.:".ilH:i: 3flriJ'3?J'ff lJT':i,l',lfl ff llffffi ;#"oi ir'":"* or tna r"tt;'
- o/oage purity of Meihyl Tertiary Br'rtyl Ether lo -be imported and ,ffi r'::1",:ri:::::i:"gruliii#'3li#i'l*i**n
- !J"n it'g" rn"v oe furnrshed'
- Details of ovp'ooucts'ii"iJo Juring the process and their recovery rn Lrms of ouantitY and value' a. inv oG"i '"r"uint information' if any' Addl industttal AdViSer ∬!」協場淵瑞 '胤 × ,¶『n:詣霧i:° DGFフU0 くい戸
9〆た `′ 9タ F No 35011/5ツ2012 PI(Norms) Govenlnlcnt of india Ministry ofChemical & Fertilizers Deparhrert of Pharmace ticals Udyog Bhawan. New Delhi, the 6'r'June' 2012' Thc undcrsigned is dircctcd to rercr to DGFT u o No 01/82/50/893/AM12′ DES-3/1460 datcd thc 15/11/1l vidC w1lich an application from ヽ4/sAヽ41 Lilcscienccs PvlしldヽVas.scnt to mk絨 1踊 淋 椰 1脚ぜi鳳 ∬ 鳳 器 跳 ∬ ― um Sub: 「ixation oF norn,s undcr para 4 7 of Hand l'ook of Proccdurcs(V011)2009- ofヽ4/s AMI Litscicnccs PVt ltd 'lhis issues with the approval ofEconomic Advisor' Department of Commel ce, (M$. Lalita Maini, FTDO), Udyog Bhawan, New Delhi. l4 Case o N Ah可→ Scction Ofaccr Pl‐Nolllls EEMOD,N-95% 0 Qty. Recommended k&/k8. -.1lsl ,7 l.or
／ シ F. No.350l l/315/2014-Pl (Nonn, Covemmentoflndia Minisnl ofChenr;cals & Fe[ilizeN Depaft nent of Phannaceulicals Udlog Bhawan.N$v Delhi. Darcd rhc'7r Septcnrber, 2015 Otfice Memorandtrin
Subject: - FixatioD of nornrs under para 4.7 of }laDd Book of PrccedLrres (Vol.l) 2009'1.1 Casc ol M/s Uninu\
Chelnicals Pvt Lkl. DGFT have ibrwarded 2 applicalions form M/s Unimax Chenricals Pvt Ltd vide their UO-N o.0 l/82/50/250/4 M l6IDES'3/166 dt 0l/072015 and 0ll82l50/'12'7/A.Ml6lDES-3/66i dr 30/07/2015 lbr Uxalion olnorms under Para 4.7 for the export ofAzithromycin Dihydrate USP fro Azithro ycin Dihydrnte lP @ I.0655k9 per kg export irr fil.st applicatiou and @ I.045kg per kg ofexport in llre seconed application. ln the above contxt, it may be stated that in 2014, another application of the firor vide DCFT UO-No. 01/82/50/165/AMl5/DES-3/l4l dt 09/05/2014 was €xamined in thh oftice and nornrs @ I.061 kg per kg of export was recommended in March'2015 based on the best actual past consumprion data duly ceftiUed by their CA. The same CA certificate has now been furnished by the firm in their application UO.No. 0 t/82/50/250/AM t6/DES-31366 dr 03/07 /2015. However, in their second applicalion refered to us vide DCFT UO.No.0l/82/50/727lAM,6/DUS,i/661 dt 30/071015, the Urnr has giten another CA certificate. The production-consumption data for 2013-14 cerified by differ€nt CA's are differenr as can be seeo hereunder, S, NO, Na e ofthe Chartered Accountant Cerlled Data F・r201314 Prod"clion (kg) Qty consumed per (kc) 1 Nathvani & Associates, Mumbai (Undated Cerrifi cate) 5162.350(rpto I I/01120t4) 1 1068 2 Darshan Nlehta & Associates, Thane (Mah.) (Dated 0l/06/20l5) 42600 10369 M/s Da$han Mehta & Associates have also certified production of 8564.10 kg ir 2014-15 wirh consunption coefficient of 1.0;15 kgkg. From the aboe, il nray be seen that the llrn has produced dillerent producrion-consln ption data tbr the relevant year of 20li-14. duly certified by different Chaiered Accounran!. If the actual consunrptioJr dara ccrtified by M/s Darshan Mehta & Associales is takcn. even lhe no nsmrifiedeadier@1.061 kgperkgofExporl is higher thaf actual pasl colrsufiplion norms ol 1.0169 kg/kg. In view ofabove, it is for norms committee to rake a final decision in lhe matter. [,4u ^." ^t+- under selre Jr\ " ,," ";,?iirXJ,i:t;i{, :' Phone:2i071162 DirectorateGeneral of Foreigr) Trade, Deparlment ofConmerce. (Shri M.V. Si6gb. flDO),
(O.P. SharmE) Joint lndustrial Adviser f et O'l'l-2307'1442 /'' =J:i:'ililEiffiffi Shrl-Mahendra vikram Singh, FTDo, DGFT, DEs-7, udyog Bhawan, New Delhi (w.r.t. their U.O. Nos.01/82050/SIAAM-16lDES-3/68'l dated 30.07.2015 and No. F No 46C1 i/88/20is-PC-.ll Government cf lndia Department of Chemicals & Petrochemicals Room No. 223, A Wing, ShastriBhawan, New Delhi-1 10 001 Dated the September 07, 2015 M/s. PCL Oil & Solvents Ltd', M-105,2nd Floor, Connauoht Place. New Delhi- 110 001. Email ; info@pelqroup.in
Subject : Advance Authorization Application from Mts. PCL Oil & Solvents Ltd., New Delhi
tor the lmport of raw material against the export and import product fot two Licsnses (Advance Authorisation No- M )nlldtaled
). Sir. I am directed to refer to your Advance Authorization Applications received from O/o DGFT on the subjecl cited above. You are being advised to submit the following information alongwith Advance Authorisation Number:
- Technical specifications, o/ocomposition (by weight) along with specillc end use/application and the copy of export and imports products and corresponding inputs consumed.
- Details and quantity of other indigenous inputs to be used in the manufacture of the export products.
- Detailed manufacturing process along with justification for wastages at each stage and also on each ofthe raw material needs to be furnished.
- Compiete material balance indicating inpui and output material ai each siage of manufac{uring process duly certilied by Chartered Engineer (CE) specially weight of the export products.
- Whether the scrap generated in the manufacturlng process is being reused, if not, ihe technical reasons for the same may be furnished duly certified by CE.
- Details of production of export product under reference and cor.esponding consumption of inputs in the last three financial year duly certmed by CA considering weight of the find product vis-a-vis inputs.
- Small sample of export product and import products, if feasible.
- Any other relevant information. Copy to: 蛛 ヾ 0l/82050/0681/AM-16/OES-31707 dated 3'1.07.201 5).
94i- ,?+- No. 460l 1r9l2014-PC-ll Government of lndia Ministrv of Chemicals & Fertilizers Oepartmeniot Cf,emicals & Petrochemicals sias113:冦 :ll」｀ 民 :」::「::4!|な ０ ０ OFttCE MEMORANDUM 鋤悧鯉■肥牌絆ざ:憚:i鷲#職∬職 Di‐OCtyl Teraphthalate(DOTP)ar The undersigned is directed to refer to U O' No' O'I/87/050/00674/AM- 16/DEs-llvd;d;ff i6 ozzors tt"'i-rj c i r on the subject cited. above rhe oroDosal of the firm ha. o""n e'at'i"o il ins otrice' The D;partment'of chemicals L ietrochemicals recommends tne prl!"nt-nJu"n"" Authorization Application on the fotlowing basis :- me oi import Qty in KG Name of Export ‖ems rs、 Qty in KG 0400 ぃh●hぅ1,,o KG Pure Tere Phthalc AC10 υ卜υ じtyi l●1・・P, (DOTP) 2 - Ethyl Hexanol 0613 This has approval of the competent authority' 」oint industrial AdviSer Te1 011-23071442 Telefax:014‐23071187 EmaL omshanlnaOnに崎 弾鰤踏榊靴鵠 e, Fax:23062225′23061613 臨
No 46011″ 9′20´ Government of Minttry of Chemicals Department of Chemicals, Room No 223,A VVing, shast‖ 8hawan,New Delh卜110001 Dated the August 26,2015 0FFiCE MEMORANDUM Sub: Applicatlon from M′ s. Payal Petrochem Pvt Ltd., New Delhi for issu● of advan●●:iConce(Licence N● 0510394758 dttd 30.06.2015)｀for eXPOrt of Di‐OCtyl Teraphtha!ato(DOTP)and COrresponding import― re9 The undersigned is direCted to refer to u O No 01′ 87/050′00675′AM‐ 16′DES‐ |‖/661 dated 29 07 2015 from D G F T on the sublect cned above The 留Ⅷ潔記淵星ll臨鵠ξ∬躍」 lf買:ぷIス鵬恕:需嘲i性諸誂¶ : fo‖owing basis i‐ Name of ExPort Items (s) Qty in KG Name of import Item (s) ｎ 的 Ｋ Ｇ Di‐Octy:Teraphtha:ate (00TP) KG Pure Tere Phtha‖ c Acid 0400 2-Ethy Hexanol 0613 This has approval of the competent authority. 巫 ら ) 」oint lndustrial Adviser TeL 011‐ 23071442 Telefax1 01 1‐ 23071487 Ema‖ omshamaOntln :7認IF滉悪 『『服ポ幣le, Department of COmmerce. Ministry of Commerce and lnduStry, 帽羊胤1:rl:ど准賄 1電69 Fax1 2306 2225′ 23061643 詠
No 4601l179′ 2014‐ PCJI Government oflndia Dep酬濡 :7fi累熙獣 :S∫霧』 :籍1にaに Room No 223,A Wing, shastri Bhawan,New Delhi410 004 Dated the August 26. 2015 Ｏ Ｏ OFF!CE MEMORANDUM sub: Application from M′ s Payal PetrOChem PVt Ltd, New Delhi for isSue advanCe licence(Licence No 0510394759 dated 30 06 2015)for eXport Dl‐Octyl Teraphthalate{DOTP)and COrresponding import― reg !鼎雉龍L篇界彙i｀1唯踊鞍描li驀雌 fo‖owing basis■ Name of Export Items (s) Qty in KG Name ofimpon ttem(S) _ Qty in KG KG Pure Tere Phthalc Acid 0400 Di‐Octyl Teraphthalate (DOTP) 2 - Ethyl Hexanol 0643 This has approval of the competent authority' (`````′を 413) 」oint lndustrial Adviser TeL 011-23071442 Telefax1 014‐ 23071187 Emat omsharrnaOnt h 離露脂滉悪∫ :F階:『鼈le, Fax:23062225′23061613 誅
No 46011779′ 2014-PC ll Government oflndia De淵劇 :脚眠∬獣ξ∫霧電 ll砥ユ icJs Shastl Bh Da awan,New Delh1110 001 ted the AuguSt 26, 2015 Ｏ Ｏ (蝸 → 践 OFFiCE MEMORANDUM Sub: Application from M,/s Payal Petrochem Pvt' Ltd-' Ner r Delhi for issue aivance licence (Licence No. 0510394760 dated 30'06'2015) for export Di-Octyl Teraphthalate (DoTP) and corresponding import - reg' The undersigned is directed to refer to U'O No 01/87/050/00678/AM- 16/DES-lll/706 d;tJ 3i.07.20'15 from D.G.FT on the subject cited above The oiooo""r ot tn" tn, has been examined in this office. The Department of chemicals I ii"tr*n"ri"ur. recommends the present Advance Authorization Application on the following basis:- Name of Export Items (s) Qty in KG Name of import Item (s) Qty in KG D■Octy!Teraphthalate (DOTP) KG Pure Tere Phthalc Acid 0400 2-Ethyl Hexanol 0643 This has approval of the competent authority. Shri Mahendra Vikram Singh, Foreign Trade Development Otficer, Ministry of Commerce and lndustry, Tel. No 23061562, Extn.269 F axt 2306 2225 123061 61 3 」oint industrial Advise「 Tel:011-23071442 Telefax:011-23074187 Ema‖ ¨
No 46011′ 79′2014-PC‐ ll Government oflndia Ministry of Chemicals&Fert‖ lzers Department of Chemicals&Petiochemicals / Room No 223,A VVing, Shast“ Bhawan,New Delh1110 001 0ated the August 26. 2015 0FFICE MEMORANDUM Sub: Application from M/s. Payal Petrochem Pvt. Ltd., New Delhi for issue advance licence (Licence No. 0510394757 dated 30.06.2015) for export Di-Octyl Teraphthalate (DOTP) and corresponding import - reg. The undersigned is directed to refer to U.O. No. 0'1/87/050/00679/AM- 16/DES-lll/705 dated 3'1.07.2015 from D.G.F.T on the subject cited above. The proposal of the firm has been examined in this office. The Department of Chemicals & Petrochemicals recommends lhe present Advance Authorization Application on the following basis:- ダ|タ ０ ０ Name of Export Items (s) Qty in KG Name of import Item (s) Qty in KG D卜Octyl Teraphthalate (DOTP) KG Pure Tere Phthalc Acid 0400 2 - Ethyl Hexanol 0613 This has approval ofthe con 」oint lndustr al Adviser TeL 011-23071442 Telefax:011‐23071187 Ema‖ :omsharma@雨ch Sh‖ Mahendra Vikram Singh, Foreign Trade Development()frcer, Directorate General of Fore gn Trade, Department of Comme「ce, Ministry of Commerce and industry, Udyog Bhawan,New Delhi Tel No 23061562,Extn 269 Fax:23062225/23061643 誅
… F No 46011′ 54′2008-PC-1 Government oflndia Department of Chemicals & Petrochemicals Room No. 223, A Wing, Shastri Bhawan, New Delhil10 001 Dated the September 16,2015 To M/s. Haldia Petrochemicals Ltd., 1, Auckland Place, Kolkata - 700 017. E.mail : diDys!d!.&!@!8149:!!
Subject: Advance Authorization Application f.om M/s. Haldia Petrochemicals Lid., Kolkata
for the import of raw material against the export of Cyclopentane (Advance Authorisation No. 0210205925 dated 26.06.2015). Sir. I am directed to refer to your Advance Authorization Applications received from O/o DGFT on the subject cited above. You are being advised to submit the following informalion : 1 . The requirement of Naphtha to produce Cyclopentane is indicated 1:1 and also 1:1.'158; what is correct ?. 2. Complete material balance indicating input and output material at each stage for production of Cyclopentane from Naphtha duly certified by Chartered Engineer (CE). 3. Oetails of production of export product under reference and conesponding consumption of Naphtha in the last three financial year duly certified by CA. 4. Any other relevant information. Your's (O.P. Sharma) Joint lndustrial Adviser TeL 014‐ 23071442 Telefax:011-23071187 Ema■omsharmaOn cin … 名 DS311Shr Mahen“ Ⅷ 閾m師 ¨ m飢 呻 ∞Bha.・van ttm帥 (Wrt theiruO No 01′82/050′00694′ AM-16′DES ‖/848 dated 31 08 2015
eet No7Date 12′ 82 LC420!3 1,092013
Case No:35′ 12′82-
ALC″ 2013 Pany Name PlRAMAL TERPRlSES lJMITED ic No′ Date1031 0'4218! 19072013 iO l′ 82′050′ 004597Aヽ414′ : ln the light of written comments received from Department of Pharmaceuticals vide their OM o 35011/386′ 2013-P(Norms,dated 26 09 2013,it was decided to ratFy norms under Para 4 7 of HBP l as per detals given below or as applied by the nrm whicheverisless For export of I no tablet l.ll5 mg Corvedi ol USP 10.0 mg Lactose Monohydmte NF/BP (200 M€sh) Teva Crospovidone NF Lactose Monohydrate (pray dried) Pakins Materials Rel€vant, as per packing policy RA may take appropriate aclion as per the decision ofNorms Commine€ http://dgft.gov.in/exim/20oo/committee/meet-adv4 l 2 l 4.htm 09_10‐2015 `|'フ ´
2-瘍 Government oflnd a Dep翼1:需習:認繁 S:]:」ξ:鳳1硼s g⌒ 7. Suりe∝ Repcselld10n iOm Mた cene百xfl:『騎Ъ `10馳 3#:Ь湯|:LI鶏:t σ ttW material against the Advance Authori2 Ref: Uo N0 01/82/050/537/AM_06/DES_H′ 4 dated 47 4 2015 胎hf稲ま£需惜hり弗[xy置&:∬闘魁ξ冨]:;剛霧鼎|『 M・¨ぴmms お chnd詰£ ::書朧常λ驚見‖ :Thi爾魁 : 脇1塾武驚肥蜘鵡馴誡
- Iiem of Expod Qty Item of lmport Qty ft4ethyl 2-Hexyt-e- Oxocylo pentane carboxylate 94% mjn. l k9 | しyc Opentanone 99%(Min) 0 960 Kg ∠ rlexanal りolも 0864 K9
- lsoamyialcohot -8% 1t4i11 0 544 kg -lhis issues with the approval of competent authoriiy. #fl"1l',',"j';l$11!3; r-ahfl/alcldqyricCI-sr!$-rfso Deptt. ofC&PC U.O. No. ● ● 〓 ● ヨ 饉 日 ヨ 日 日 ■ ■ ■ ■ ■ ■ 口 田 ■ 田 ｒ ■ ‐ ｒ ■ ■ ■ 旧 旧 旧 旧 聞 口 田 用 ＝ ■ ョ ョ ロ ■ １ ■ １ 〓 〓 ― ‥ ‥ １１ ■ ― ― ― ― ― ― ■ ■ ■ ＋
F No 14010/36′2010‐ CH‐ | Government ofindia Min stry Of chem ca s and Fert‖ zers Subject: Advance Authorization application from l.4/s. Yashashvi Rasayan Pvt. Ltd. for the import of raw materials against the export of THISA (Advance Authorization No. 5210040'190 dated 12.9.2014) (Advance Authorization No. 5210040666 dated 3.2.2014) Ref: UO No 01/82/050′ 0224/AM15′ DES‐ |‖′320 dated 3006 2014 and Case No 141′ 13/82 ALC4/2014′ in meeting No ALC4′ 2015heldon1542015 M/s. Yashashvi Rasayan Pvt. Ltd. has submitted present application as well as representation against earlier approved quantity of 1 .48 kg of Thiophanone for the export of 1 kg of THISA. The firm have indicated the followings in the representation (i) The foreign buyer M/s. Saltigo, GmbH, Germany has suggested the firm to manufacture THISA and provided the manufacturing process for doing trial runs in R&D centre of the firm. (ii) Firm have referred the two US patents for various reactions (US Patent No. 00041301A and 696493981). The yield achieved by the firm higher than two US patents which is due to extensive work in R&D centre. (iii) As per the CA Certificate, the average qty. of raw materials works out to 2.022 kglkg as against the applied quantity of 2.05 kg/kg. The representation has been examined and accordingly the Department of C&PC recommends the following norms for the above Advance Authorization applications. '1. ltem of Export Qty Item of lmport Qty THISA (Methy 4」 (am nOSulfonyり‐ 5‐ methylthiophene‐ 3‐ carboxylate l kg
- Thiophanone 2020 K9 Addl industr al Advise「 Tel No 011‐23381430 shn Mahender Ⅵkram SinOh FTDO (DES‐ ‖:)0/o DGFT Udvo●Bhawan Nevr De hi-11 Deptt Of C&PC U O No 14010/36′ 2011・CH‐ ‖ date^' 72015 (A K ASARい′AL) |■19、 ■|ハ)
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