1
Office of Directorate General of Foreign Trade New Delhi -0
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Para 4.7 Decision
Minutes of the Norms Committee – 3 Meeting No. 7/82-ALC4/2019 dated 06.09.2019 (actually held on 06.09.2019 and 24.09.2019) for considering the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products falling under Chapter 29 and 30, held under the Chairmanship of Shri Satyan Sharda, Addl. DGFT in Room No.11, Udyog Bhawan, New Delhi.
Following members were present:-
(i) Shri Nirmal Kumar, Dy. Director General of Foreign Trade (ii) Shri Ajay Kumar, Assistant Director (iii) Consultant, Technical Expert Pharmaceuticals (iv) Consultant, Technical Expert Chemicals
The committee went through the minutes of earlier meeting No. 6/82-ALC4/2019 dated 16.08.2019 (actually held on 23.08.2019) and approved the same.
MEETING NUMBER : 7/82-ALC4/2019 MEETING DATE : 16.08.2019 (actually held on 23.08.2019)
| Case No.:59/10/82-ALC4/2013 |
|
Party Name:MYLAN |
|
Meet No/Date:7/82- |
|
Status: |
|
|
LABORATORIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910055390 |
|
Defer Date |
| :01/82/050/00242/AM14/ |
|
:09/24/040/00585/AM13/ |
|
14.03.2013 |
|
|
1 Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm:
(i) Step wise complete and balanced chemical reaction with molecular weight of each component. (ii) Requirement and recovery of solvents.
| Case No.:2/6/82-ALC4/2014 |
|
Party Name:SOFTGEL |
|
Meet No/Date:7/82- |
|
Status: |
|
|
HEALTH CARE PVT. LTD., |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0410159058 |
|
Defer Date |
| :01/82/050/00404/AM15/ |
|
:04/24/040/00031/AM15/ |
|
22.07.2014 |
|
|
Decision: The Committee considered the case as per agenda in the presence of technical experts and it was 2 noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 2/82-ALC4/2019 dated 21.06.2019, followed by reminder on 30.07.2019
(i) Copy of valid Drug Manufacturing Licence for both the export products.
In view of above, the Committee decided to issue Final Reminder to firm giving 15 days time to furnish its reply, failing which the case will be rejected.
2
| Case No.:91/13/82-ALC4/2014 |
|
Party Name:INCHEM |
|
Meet No/Date:7/82- |
|
Status: |
|
|
LABORATORIES PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910061287 |
|
|
| :01/82/050/01094/AM15/ |
|
:09/24/040/00421/AM15/ |
|
21.11.2014 |
|
|
|
Case No.:91/13/82-ALC4/2014 |
Party Name:INCHEM<br>LABORATORIES PRIVATE<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/01094/AM15/ |
RLA File<br>:09/24/040/00421/AM15/ |
Lic.No/Date:0910061287<br>21.11.2014 |
|
| 3 |
**Decision:**The Committee considered case as per agenda and in the presence of the technical experts, it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as 0per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Ractopamine Hcl<br>1 kg<br>1<br>Amino Aceto Nitrile Hcl<br>Raw material<br>0.85 kg<br>2<br>Nitro<br>Methane<br>Raw material<br>Not shown in the<br>reaction<br>3<br>Aluminium<br>Chloride<br>Raw material<br>1.717 kg<br>4<br>Phenol<br>Raw material<br>1.00 kg<br>5<br>4 (4 hydroxy phenyl ) 2<br>butanone<br>Raw materail<br>0.70 kg<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as 0per details below or as applied by firm whichever is lower:
| 4 |
Case No.:948/15/82-<br>ALC4/2018 |
Party Name:ADCOCK<br>INGRAM LTD, |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/02405/AM19/ |
RLA File<br>:07/24/040/00043/AM16/ |
Lic.No/Date:0710108280<br>27.05.2015 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
3
| Case No.:1063/15/82- |
|
Party Name:MALLADI |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
DRUGS & |
|
ALC4/2019 |
|
Approved |
|
|
PHARMACEUTICALS |
|
06.09.2019 |
|
|
|
|
LIMITED |
|
|
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0410160592 |
|
|
| :01/82/050/02520/AM19/ |
|
:04/24/040/00046/AM16/ |
|
27.05.2015 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 3/82-ALC4/2019 dated 05.07.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
5
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
No. |
|
|
|
Phenylepherine Bitartrate |
1 kg |
1 |
3-Hydroxy Acetophenone |
1.92 kg |
|
|
|
2 |
Methanol |
3.42 kg |
|
|
|
3 |
L(+)Tartaric Acid |
2.00 kg |
|
|
|
4 |
Methyl Isobutyl Ketone |
Not shown in |
|
|
|
|
|
CE certificate |
|
|
|
5 |
Acetic Anhydride |
1.60 kg |
|
|
|
6 |
Iso Propyl Alcohol |
5.17 kg |
|
|
|
7 |
Caustic soda Flakes |
0.46 kg |
RA may take appropriate action as per the decision of Norms Committee.
|
|
Case No.:950/15/82- |
|
Party Name:ADCOCK |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
INGRAM LTD, |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 6 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0710108316 |
|
Defer Date |
|
|
:01/82/050/02407/AM19/ |
|
:07/24/040/00065/AM16/ |
|
04.06.2015 |
|
|
|
|
Decision: Deferred for comments of TE. |
|
|
|
|
|
|
| Case No.:1064/15/82- |
|
Party Name:MALLADI |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
DRUGS & |
|
ALC4/2019 |
|
Approved |
|
|
PHARMACEUTICALS |
|
06.09.2019 |
|
|
|
|
LIMITED |
|
|
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0410160680 |
|
|
| :01/82/050/02521/AM19/ |
|
:04/24/040/00055/AM16/ |
|
16.06.2015 |
|
|
|
|
**Decision:**The Committee considered case as |
**Decision:**The Committee considered case as |
**Decision:**The Committee considered case as |
**Decision:**The Committee considered case as |
per agenda and in the presence of the technical experts, it |
per agenda and in the presence of the technical experts, it |
per agenda and in the presence of the technical experts, it |
per agenda and in the presence of the technical experts, it |
|
|
was decided to ratify the |
|
ad-hoc input output norms under para 4.7 of HBP as 0per details below or as |
|
|
|
|
|
|
|
applied by firm whichever is lower: |
|
|
|
|
|
|
|
| 7 |
|
|
Export product |
|
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
|
|
|
No. |
|
|
|
|
|
|
4-Methyl-5-phenyl-2- |
|
1 kg |
1 |
Propiophenone |
2.44 kg |
|
|
|
|
oxazolidinone |
(Racemic |
|
2 |
Diethyl Carbonate |
1.00 kg |
|
|
|
|
Oxazolidinone) |
|
|
3 |
Toluene |
5.78 kg |
|
|
|
|
|
|
|
4 |
Iso Propyl Alcohol |
1.91 kg |
|
|
|
|
|
|
|
5 |
Heptane |
2.71 kg |
|
|
|
|
|
|
|
6 |
Acetone |
0.47 kg |
|
|
|
|
|
|
|
7 |
Caustic soda Flakes |
0.48 kg |
|
|
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as 0per details below or as applied by firm whichever is lower:
4
| Case No.:1065/15/82- |
|
Party Name:MALLADI |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
DRUGS & |
|
ALC4/2019 |
|
Approved |
|
|
PHARMACEUTICALS |
|
06.09.2019 |
|
|
|
|
LIMITED |
|
|
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0410160689 |
|
|
| :01/82/050/02522/AM19/ |
|
:04/24/040/00056/AM16/ |
|
18.06.2015 |
|
|
|
|
ALC4/2018<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED<br>ALC4/2019<br>06.09.2019<br>Approved<br>HQ File<br>:01/82/050/02522/AM19/<br>RLA File<br>:04/24/040/00056/AM16/<br>Lic.No/Date:0410160689<br>18.06.2015 |
ALC4/2018<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED<br>ALC4/2019<br>06.09.2019<br>Approved<br>HQ File<br>:01/82/050/02522/AM19/<br>RLA File<br>:04/24/040/00056/AM16/<br>Lic.No/Date:0410160689<br>18.06.2015 |
ALC4/2018<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED<br>ALC4/2019<br>06.09.2019<br>Approved<br>HQ File<br>:01/82/050/02522/AM19/<br>RLA File<br>:04/24/040/00056/AM16/<br>Lic.No/Date:0410160689<br>18.06.2015 |
ALC4/2018<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED<br>ALC4/2019<br>06.09.2019<br>Approved<br>HQ File<br>:01/82/050/02522/AM19/<br>RLA File<br>:04/24/040/00056/AM16/<br>Lic.No/Date:0410160689<br>18.06.2015 |
ALC4/2018<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED<br>ALC4/2019<br>06.09.2019<br>Approved<br>HQ File<br>:01/82/050/02522/AM19/<br>RLA File<br>:04/24/040/00056/AM16/<br>Lic.No/Date:0410160689<br>18.06.2015 |
ALC4/2018<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED<br>ALC4/2019<br>06.09.2019<br>Approved<br>HQ File<br>:01/82/050/02522/AM19/<br>RLA File<br>:04/24/040/00056/AM16/<br>Lic.No/Date:0410160689<br>18.06.2015 |
ALC4/2018<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED<br>ALC4/2019<br>06.09.2019<br>Approved<br>HQ File<br>:01/82/050/02522/AM19/<br>RLA File<br>:04/24/040/00056/AM16/<br>Lic.No/Date:0410160689<br>18.06.2015 |
ALC4/2018<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED<br>ALC4/2019<br>06.09.2019<br>Approved<br>HQ File<br>:01/82/050/02522/AM19/<br>RLA File<br>:04/24/040/00056/AM16/<br>Lic.No/Date:0410160689<br>18.06.2015 |
|
|
**Decision:**The Committee considered case as per agenda and in the presence of the technical experts, it |
|
|
|
|
|
|
|
|
|
was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as 0per details below or as |
|
|
|
|
|
|
|
|
|
applied by firm whichever is lower: |
|
|
|
|
|
|
|
| 8 |
|
|
Export product |
|
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
|
|
|
No. |
|
|
|
|
|
|
(4S,5R)-(-)-4-Methyl-5-phenyl-2- |
|
1 kg |
1 |
Propiophenone |
5.98 kg |
|
|
|
|
oxazolidinone |
(Chiral |
|
2 |
Diethyl Carbonate |
0.95 kg |
|
|
|
|
Oxazolidinone) |
|
|
3 |
Toluene |
8.90 kg |
|
|
|
|
|
|
|
4 |
Iso Propyl Alcohol |
11.22 kg |
|
|
|
|
|
|
|
5 |
Heptane |
6.82 kg |
|
|
|
|
|
|
|
6 |
Methyl Isobutyl Ketone |
3.11 kg |
|
|
|
|
|
|
|
7 |
Acetone |
3.56 kg |
|
|
|
|
|
|
|
8 |
Caustic soda Flakes |
3.11 kg |
|
|
|
RA maytake appropriate |
|
action asper the decision of Norms Committee. |
|
|
|
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as 0per details below or as applied by firm whichever is lower:
|
|
Case No.:959/15/82- |
Case No.:959/15/82- |
|
Party Name:DR REDDYS |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
|
LABORATORIES LIMITED |
|
ALC4/2019 |
|
Withdrawn |
|
|
|
|
|
|
|
06.09.2019 |
|
|
|
|
HQ File |
|
|
RLA File |
|
Lic.No/Date:0910062340 |
|
|
| 9 |
|
:01/82/050/02416/AM19/ |
|
|
:09/24/040/00222/AM16/ |
|
16.07.2015 |
|
|
|
|
Decision: |
RLA, Hyderabad vide e-mail dated 18.07.2019 |
|
|
|
has informed that the subject advance |
|
|
|
|
authorization |
was issued under Non-Infringing Process and EODC |
|
|
has already been issued. |
|
|
|
|
|
|
In view of above,the Committee decided towithdrawthe case. |
|
|
|
|
|
|
5
| Case No.:961/15/82- |
|
Party Name:MALLADI |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
DRUGS & |
|
ALC4/2019 |
|
Approved |
|
|
PHARMACEUTICALS |
|
06.09.2019 |
|
|
|
|
LIMITED |
|
|
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0410160849 |
|
|
| :01/82/050/02418/AM19/ |
|
:04/24/040/00102/AM16/ |
|
30.07.2015 |
|
|
|
|
**Decision:**The Committee considered the cases |
**Decision:**The Committee considered the cases |
**Decision:**The Committee considered the cases |
as per agenda and in the light of earlier decision taken in |
as per agenda and in the light of earlier decision taken in |
as per agenda and in the light of earlier decision taken in |
as per agenda and in the light of earlier decision taken in |
|
|
meeting no. 3/82-ALC4/2019 dated 05.07.2019, it |
|
|
was decided to ratify norms under Para |
|
4.7 of HBP v1 as |
|
|
|
per details given below or as applied by the firm, whichever is less: |
|
|
|
|
|
|
| 10 |
|
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
|
|
No. |
|
|
|
|
|
|
Phenylepherine Bitartrate USP |
1 kg |
1 |
3-Hydroxy Acetophenone |
1.92 kg |
|
|
|
|
|
|
2 |
Methanol |
3.42 kg |
|
|
|
|
|
|
3 |
L(+)Tartaric Acid |
2.00 kg |
|
|
|
|
|
|
4 |
Methyl Isobutyl Ketone |
Not shown in |
|
|
|
|
|
|
|
|
CE certificate |
|
|
|
|
|
|
5 |
Acetic Anhydride |
1.60 kg |
|
|
|
|
|
|
6 |
Iso Propyl Alcohol |
5.17 kg |
|
|
|
|
|
|
7 |
Caustic soda Flakes |
0.46 kg |
|
|
|
RA maytake appropriate action asper the |
|
decision |
of Norms Committee. |
|
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 3/82-ALC4/2019 dated 05.07.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
| Case No.:963/15/82- |
|
Party Name:MALLADI |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
DRUGS & |
|
ALC4/2019 |
|
Approved |
|
|
PHARMACEUTICALS |
|
06.09.2019 |
|
|
|
|
LIMITED |
|
|
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0410160864 |
|
|
| :01/82/050/02420/AM19/ |
|
:04/24/040/00104/AM16/ |
|
04.08.2015 |
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 10/82-ALC4/2018 , dated 16.10.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as 11 per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| N-t-Boc-trans-4-hydroxy-L- |
1 kg |
1 |
Trans-4-hydroxy-l-proline |
0.886 kg |
| proline |
|
2 |
Di-tertbutyldicarbonate |
1.51 kg |
|
|
3 |
Ethyl Acetate |
2.50 kg |
|
|
4 |
Caustic soda Flakes |
0.30 kg |
RA concerned may take further necessary action as per above decision of NC.
6
| Case No.:966/15/82- |
|
Party Name:GRANULES |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
INDIA LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910062538 |
|
|
| :01/82/050/02423/AM19/ |
|
:09/24/040/00303/AM16/ |
|
27.08.2015 |
|
|
|
|
Decision: |
The Committee considered the case as |
The Committee considered the case as |
The Committee considered the case as |
The Committee considered the case as |
The Committee considered the case as |
per |
agenda in the presence of Technical Experts and |
agenda in the presence of Technical Experts and |
agenda in the presence of Technical Experts and |
agenda in the presence of Technical Experts and |
agenda in the presence of Technical Experts and |
|
|
|
in<br>the<br>light |
of<br>earlier |
decision |
|
taken |
by |
NC |
|
<br>in<br>its<br>Meeting |
No. |
2/82-ALC4/2013 |
|
|
|
|
, dated 18.04.2013, it was decided to ratify the ad-hoc input |
|
|
|
|
|
|
|
output norms under para 4.7 |
|
of HBP Vol. I as |
|
|
|
|
per details below |
or as applied by firm whichever is lower: |
|
|
|
|
|
|
|
|
|
|
|
| 12 |
|
Export product |
|
|
|
Qty. |
Sl. |
|
|
Import items |
|
|
Qty. |
|
|
|
|
|
|
|
|
No. |
|
|
|
|
|
|
|
|
|
Compresso |
Cotrim |
90 |
|
1 kg |
1. |
|
|
Sulfamethoxazole |
|
|
0.750 kg |
|
|
|
(Sulfamethoxazole |
|
and |
|
|
2. |
|
|
Trimethoprim |
|
|
0.150 kg |
|
|
|
Trimethoprim Granules DC) |
|
|
|
|
3. |
|
|
Pregelatinised Starch |
|
|
0.043 kg |
|
|
|
|
|
|
|
|
4. |
|
|
Croscarmellose Sodium |
|
|
0.040 kg |
|
|
|
|
|
|
|
|
5. |
|
|
Povidone K-30 |
|
|
0.006 kg |
|
|
|
|
|
|
|
|
6. |
|
|
Sodium Lauryl Sulfate |
|
|
0.001 kg |
|
|
|
|
|
|
|
|
7. |
|
|
Stearic Acid |
|
|
0.010 kg |
|
|
|
RA concerned maytake further necessary |
|
|
|
action asper above decision of NC. |
|
|
|
|
|
|
|
|
|
|
Case No.:486/15/82-<br>Party Name:GLENMARK |
|
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018<br>PHARMACEUTICALS LTD., |
|
|
ALC4/2019 |
|
Withdrawn |
|
|
|
|
|
06.09.2019 |
|
|
|
|
HQ File<br>RLA File |
|
|
Lic.No/Date:0310798582 |
|
|
| 13 |
|
:01/82/050/01943/AM19/<br>:03/94/040/00250/AM16/ |
|
|
31.08.2015 |
|
|
|
|
**Decision:**RLA, Mumbai vide e-mail dated 07.08.2019 |
has informed that the subject Advance |
|
|
|
|
|
|
Authorization has already been redeemed. |
|
|
|
|
|
|
|
In view of above,the Committee decided towithdrawthe case. |
|
|
|
|
|
Decision: RLA, Mumbai vide e-mail dated 07.08.2019 has informed that the subject Advance Authorization has already been redeemed.
|
|
Case No.:969/15/82- |
|
Party Name:SOMU |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
SOLVENTS PVT. LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 14 |
|
HQ File<br>:01/82/050/02426/AM19/ |
|
RLA File<br>:07/24/040/00175/AM16/ |
|
Lic.No/Date:0710108673<br>02.09.2015 |
|
Defer Date |
|
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not |
|
|
|
|
|
|
|
|
available. Hence, it was decided |
to call for a copy of 4.07 application of the subject advance |
|
|
|
authorization |
|
|
|
from RLA Bangalore. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Bangalore.
|
|
Case No.:405/15/82- |
|
Party Name:SHIVA |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
PHARMACHEM LTD, |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 15 |
|
HQ File<br>:01/82/050/01862/AM19/ |
|
RLA File<br>:34/24/040/00139/AM16/ |
|
Lic.No/Date:3410041522<br>16.09.2015 |
|
Defer Date |
|
|
**Decision:**The Committee |
|
noted that the 4.07 application |
of subject Advance Authorization is not |
|
|
|
|
|
available. Hence, it was decided |
to call for a copy of 4.07 application of the subject advance |
|
|
|
authorization |
|
|
|
from RLA Vadodara. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Vadodara.
7
| 16 |
Case No.:259/15/82-<br>ALC4/2018 |
Party Name:CADILA<br>PHARMACEUTICALS LTD. |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01716/AM19/ |
RLA File<br>:08/24/040/00222/AM16/ |
Lic.No/Date:0810136251<br>12.10.2015 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA Ahmedabad. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Ahmedabad.
| 17 |
Case No.:322/15/82-<br>ALC4/2018 |
Party Name:HESTER<br>BIOSCIENCES LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01779/AM19/ |
RLA File<br>:08/24/040/00270/AM16/ |
Lic.No/Date:0810136418<br>02.11.2015 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not available.<br>Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA,<br>Ahmedabad. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Ahmedabad.
| Case No.:984/15/82- |
|
Party Name:BELOOR BAYIR |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
BIOTECH LTD, |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710109127 |
|
|
| :01/82/050/02441/AM19/ |
|
:07/24/040/00287/AM16/ |
|
03.12.2015 |
|
|
Decision: The Committee considered case as per agenda and as per earlier decision taken by NC in its 13/82-ALC4/2018 meeting dated 14.01.2019, it was decided to ratify the ad-hoc input output norms under 18 para 4.7 of HBP as per details below or as applied by firm whichever is lower:-
| Export product<br>SOFOSBUVIR FORM 6(IH GRADE) |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
|
1 kg |
1 |
2 DEOXY 2 FLUORO 2 C<br>METHYLURIDINE |
0.90 kg |
RA concerned may take further necessary action as per above decision of NC
| Case No.:1030/15/82- |
|
Party Name:SWATI |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
MENTHOL & ALLIED |
|
ALC4/2019 |
|
Deferred |
|
|
CHEMICALS LTD., |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:2910025235 |
|
Defer Date |
| :01/82/050/02487/AM19/ |
|
:29/21/040/00029/AM16/ |
|
21.12.2015 |
|
|
19 Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm:
(i) Complete 4E with all technical details chemistry, molecular weight, stoichiometric reaction and % of yield at every stage. (ii) Central Excise or GST Certificate
8
| Case No.:215/15/82- |
|
Party Name:DISHMAN |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
PHARMACEUTICALS & |
|
ALC4/2019 |
|
Approved |
|
|
CHEMICALS LTD |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0810136941 |
|
|
| :01/82/050/01672/AM19/ |
|
:08/24/040/00132/AM16/ |
|
05.01.2016 |
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 10/82-ALC4/2018 , dated 16.10.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as 20 per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| ETHYL TRIPHENYL<br>PHOSPHONIUM CHLORIDE |
1 kg |
1 |
TRIPHENYL PHOSPHINE |
0.78 kg |
|
|
2 |
ETHYL BROMIDE |
0.23 kg |
| 21 |
<br>Case No.:494/15/82-<br>ALC4/2018 |
Party Name:BDR<br>PHARMACEUTICALS<br>INTERNATIONAL PVT. LTD.<br>RLA File<br>:03/94/040/00818/AM16/ |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01951/AM19/ |
|
Lic.No/Date:0310801693<br>11.01.2016 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 22 |
Case No.:260/15/82-<br>ALC4/2018 |
Party Name:VINNY<br>HEALTHCARE PRIVATE<br>LIMITED<br>RLA File<br>:08/24/040/00386/AM16/ |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01717/AM19/ |
|
Lic.No/Date:0810137198<br>12.02.2016 |
Defer Date |
|
**Decision:**The Committee<br>available. Hence, it was decided<br>from RLA Ahmedabad. |
noted that the 4.07 application of subject Advance Authorization is not<br>to call for a copy of 4.07 application of the subject advance authorization |
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Ahmedabad.
|
Case No.:218/15/82- |
|
Party Name:VIRCHOW |
|
Meet No/Date:7/82- |
|
Status: |
|
ALC4/2018 |
|
PETROCHEMICAL PVT LTD. |
|
ALC4/2019 |
|
Withdrawn |
|
|
|
|
|
06.09.2019 |
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910063299 |
|
|
|
:01/82/050/01675/AM19/ |
|
:09/24/040/00655/AM16/ |
|
19.02.2016 |
|
|
23 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was observed that the norms for the subject Advance Authorization have already been ratified by NC-3 in its Meeting No. 2/AM20 dated 21.06.2019 (Case No. B-6).
, the Committee decided to withdraw the case.
9
|
|
Case No.:996/15/82- |
|
Party Name:RECKITT |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
BENCKISER ( INDIA) LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 24 |
|
HQ File<br>:01/82/050/02453/AM19/ |
|
RLA File<br>:07/24/040/00374/AM16/ |
|
Lic.No/Date:0710109433<br>23.02.2016 |
|
Defer Date |
|
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not |
|
|
|
|
|
|
|
|
available. Hence, it was decided |
to call for a copy of 4.07 application of the subject advance |
|
|
|
authorization |
|
|
|
from RLA Bangalore. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Bangalore.
|
|
Case No.:1006/15/82- |
|
Party Name:STELLENCE |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
PHARMSCIENCE PVT LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 25 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0710109590 |
|
Defer Date |
|
|
:01/82/050/02463/AM19/ |
|
:07/24/040/00420/AM16/ |
|
29.03.2016 |
|
|
|
|
**Decision:**Deferred for comments of T.E. |
|
|
|
|
|
|
|
Case No.:219/15/82- |
|
Party Name:VIRCHOW |
|
Meet No/Date:7/82- |
|
Status: |
|
ALC4/2018 |
|
PETROCHEMICAL PVT LTD. |
|
ALC4/2019 |
|
Withdrawn |
|
|
|
|
|
06.09.2019 |
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910063474 |
|
|
|
:01/82/050/01676/AM19/ |
|
:09/24/040/00753/AM16/ |
|
31.03.2016 |
|
|
26 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was observed that the norms for the subject Advance Authorization have already been ratified by NC-3 in its Meeting No. 2/AM20 dated 21.06.2019 (Case No. B-6).
, the Committee decided to withdraw the case.
|
|
Case No.:221/15/82- |
|
Party Name:GOPINATH |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
CHEM-TECH LTD., |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 27 |
|
HQ File<br>:01/82/050/01678/AM19/ |
|
RLA File<br>:08/24/040/00469/AM16/ |
|
Lic.No/Date:0810137649<br>11.04.2016 |
|
Defer Date |
|
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not |
|
|
|
|
|
|
|
|
available. Hence, it was decided |
to call for a copy of 4.07 application of the subject advance |
|
|
|
authorization |
|
|
|
from RLA Ahmedabad. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Ahmedabad.
|
|
Case No.:274/15/82- |
|
|
Party Name:SHILPA |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
|
MEDICARE LTD., |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
|
06.09.2019 |
|
|
| 28 |
|
HQ File<br>:01/82/050/01731/AM19/ |
|
|
RLA File<br>:07/24/040/00034/AM17/ |
|
Lic.No/Date:0710109729<br>27.04.2016 |
|
Defer Date |
|
|
**Decision:**The Committee |
noted that the 4.07 application of subject Advance Authorization is not |
|
|
|
|
|
|
|
|
available. Hence, it was decided |
|
to call for a copy of 4.07 application of the subject advance |
|
|
|
authorization |
|
|
|
from RLA Bangalore. |
|
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Bangalore.
10
| 29 |
<br>Case No.:222/15/82-<br>ALC4/2018 |
Party Name:ADCOCK<br>INGRAM LTD, |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01679/AM19/ |
RLA File<br>:07/24/040/00015/AM17/ |
Lic.No/Date:0710109746<br>02.05.2016 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 30 |
<br>Case No.:223/15/82-<br>ALC4/2018 |
Party Name:ADCOCK<br>INGRAM LTD, |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01680/AM19/ |
RLA File<br>:07/24/040/00018/AM17/ |
Lic.No/Date:0710109744<br>02.05.2016 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 31 |
<br>Case No.:224/15/82-<br>ALC4/2018 |
Party Name:ADCOCK<br>INGRAM LTD, |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01681/AM19/ |
RLA File<br>:07/24/040/00019/AM17/ |
Lic.No/Date:0710109754<br>03.05.2016 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 32 |
Case No.:286/15/82-<br>ALC4/2018 |
Party Name:MOREPEN<br>LABORATORIES LTD., |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01743/AM19/ |
RLA File<br>:05/24/040/00060/AM17/ |
Lic.No/Date:0510398453<br>11.05.2016 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from CLA,New Delhi. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA ,New Delhi.
| Case No.:225/15/82- |
|
Party Name:VIVIMED LABS ( |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
ALATHUR) PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0410161928 |
|
Defer Date |
| :01/82/050/01682/AM19/ |
|
:04/24/040/00012/AM17/ |
|
12.05.2016 |
|
|
Decision: The Committee considered the case as per online agenda in the presence of technical experts 33 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 15/82-ALC4/2018 dated 22.03.2019 followed by Final Reminder on 01.08.2019:
(i) Drug Manufacturing License of the export product. (ii) Master Batch Formula of the export product.
ply awaited from the firm.
11
| Case No.:226/15/82- |
|
Party Name:STELLENCE |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
PHARMSCIENCE PVT LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710109873 |
|
|
| :01/82/050/01683/AM19/ |
|
:07/24/040/00040/AM17/ |
|
26.05.2016 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as 0per details below or as 34 applied by firm whichever is lower:
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
No. |
|
|
|
L-SELENOMETHIONINE |
1 kg |
1 |
L-METHIONINE |
1.812 kg |
|
|
|
2 |
SELENIUM METAL POWDER |
1.00 kg |
| RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
| 35 |
Case No.:540/15/82-<br>ALC4/2018 |
Party Name:SUPRIYA<br>LIFESCIENCE LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Withdrawn |
|
<br>HQ File<br>:01/82/050/01997/AM19/ |
RLA File<br>:03/95/040/00144/AM17/ |
Lic.No/Date:0310805016<br>30.05.2016 |
|
|
Decision:RLA, Mumbai vide e-mail dated 07.08.2019 has informed that the subject Advance<br>Authorization has already been redeemed.<br>In view of above,the Committee decided towithdrawthe case. |
|
|
|
Decision: RLA, Mumbai vide e-mail dated 07.08.2019 has informed that the subject Advance Authorization has already been redeemed.
| Case No.:227/15/82- |
|
Party Name:RA CHEM |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
PHARMA LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910063745 |
|
|
| :01/82/050/01684/AM19/ |
|
:09/24/040/00108/AM17/ |
|
03.06.2016 |
|
|
|
Case No.:227/15/82-<br>ALC4/2018 |
Party Name:RA CHEM<br>PHARMA LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/01684/AM19/ |
RLA File<br>:09/24/040/00108/AM17/ |
Lic.No/Date:0910063745<br>03.06.2016 |
|
| 36 |
<br>**Decision:**The Committee considered case as per agenda and in the presence of the technical experts, it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as 0per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>RACTOPAMINE HCL<br>1 kg<br>1<br>Amino Acetonitrile<br>Hydrochloride<br>0.85 kg<br>2<br>Nitromethane<br>Not shown in the<br>reaction<br>3<br>Methanol<br>3.36 kg<br>4<br>Acetone<br>0.47 kg<br>5<br>4-(4-Hydroxy Phenyl)-2-<br>Butanone<br>0.70 kg<br>6<br>Ethyl Acetate<br>0.41 kg<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as 0per details below or as applied by firm whichever is lower:
12
37
|
Case No.:228/15/82- |
|
Party Name:VIRCHOW |
|
Meet No/Date:7/82- |
|
Status: |
|
ALC4/2018 |
|
PETROCHEMICAL PVT LTD. |
|
ALC4/2019 |
|
Withdraw |
|
|
|
|
|
06.09.2019 |
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910063766 |
|
|
|
:01/82/050/01685/AM19/ |
|
:09/24/040/00782/AM16/ |
|
08.06.2016 |
|
|
Decision: The Committee considered the case as per agenda in the presence of technical experts and it was observed that the norms for the subject Advance Authorization have already been ratified by NC-3 in its Meeting No. 2/AM20 dated 21.06.2019 (Case No. B-6).
, the Committee decided to withdraw the case.
| 38 |
Case No.:229/15/82-<br>ALC4/2018 |
Party Name:VIRCHOW<br>PETROCHEMICAL PVT LTD. |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Lic.No/Date:0910063767<br>08.06.2016 |
Status:<br>Withdrawn |
|
<br>HQ File<br>:01/82/050/01686/AM19/ |
RLA File<br>:09/24/040/00757/AM16/ |
|
|
|
<br>Decision:The Committee considered the case as per agenda in the presence of technical<br>was observed that the norms for the subject Advance Authorization have already been ratified<br>Meeting No. 2/AM20 dated 21.06.2019 (Case No. B-6).<br>In view of above,the Committee decided towithdrawthe case. |
|
|
experts and it<br>by NC-3 in its |
| 39 |
Case No.:230/15/82-<br>ALC4/2018 |
Party Name:WINTAC<br>LIMITED, |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Lic.No/Date:0710109922<br>08.06.2016 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/01687/AM19/ |
RLA File<br>:07/24/040/00083/AM17/ |
|
|
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA Bangalore. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Bangalore.
| 40 |
Case No.:231/15/82-<br>ALC4/2018 |
Party Name:WINTAC<br>LIMITED, |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Lic.No/Date:0710109921<br>08.06.2016 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/01688/AM19/ |
RLA File<br>:07/24/040/00082/AM17/ |
|
|
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA Bangalore. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Bangalore.
| 41 |
Case No.:501/15/82-<br>ALC4/2018 |
Party Name:WINTAC<br>LIMITED, |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Lic.No/Date:0710109926<br>09.06.2016 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/01958/AM19/ |
RLA File<br>:07/24/040/00081/AM17/ |
|
|
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA Bangalore. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Bangalore.
13
|
|
Case No.:234/15/82- |
|
|
Party Name:R L FINE CHEM |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
|
|
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
|
06.09.2019 |
|
|
| 42 |
|
HQ File<br>:01/82/050/01691/AM19/ |
|
|
RLA File<br>:07/24/040/00057/AM17/ |
|
Lic.No/Date:0710109991<br>23.06.2016 |
|
Defer Date |
|
|
**Decision:**The Committee |
noted that the 4.07 application of subject Advance Authorization is not |
|
|
|
|
|
|
|
|
available. Hence, it was decided |
|
to call for a copy of 4.07 application of the subject advance |
|
|
|
authorization |
|
|
|
from RLA Bangalore. |
|
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Bangalore.
|
|
Case No.:270/15/82- |
|
Party Name:ARKRAY |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
HEALTHCARE PVT.LTD. |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 43 |
|
HQ File<br>:01/82/050/01727/AM19/ |
|
RLA File<br>:52/24/040/00025/AM17/ |
|
Lic.No/Date:5210041960<br>14.07.2016 |
|
Defer Date |
|
|
**Decision:**The Committee |
|
noted that the 4.07 application of subject Advance Authorization is not |
|
|
|
|
|
|
available. Hence, it was decided |
to call for a copy of 4.07 application of the subject advance |
|
|
|
authorization |
|
|
|
from RLA Surat. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Surat.
|
|
Case No.:477/15/82- |
|
Party Name:STELLENCE |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
PHARMSCIENCE PVT LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 44 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0710110111 |
|
Defer Date |
|
|
:01/82/050/01934/AM19/ |
|
:07/24/040/00143/AM17/ |
|
15.07.2016 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:240/15/82- |
Party Name:VIRCHOW |
|
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
PETROCHEMICAL PVT LTD. |
|
|
ALC4/2019 |
|
Withdrawn |
|
|
|
|
|
|
06.09.2019 |
|
|
|
|
HQ File |
RLA File |
|
|
Lic.No/Date:0910063941 |
|
|
| 45 |
|
:01/82/050/01697/AM19/<br>:09/24/040/00048/AM17/<br>**Decision:**The Committee considered the case as per agenda |
|
18.07.2016<br>in the presence of technical |
|
|
experts and it |
|
|
|
was observed that the norms for the subject Advance Authorization have already been ratified |
|
|
|
|
by NC-3 in its |
|
|
|
Meeting No. 2/AM20 dated 21.06.2019 (Case No. B-6). |
|
|
|
|
|
|
|
|
In view of above,the Committee decided towithdrawthe case. |
|
|
|
|
|
|
Decision: The Committee considered the case as per agenda in the presence of technical experts and it was observed that the norms for the subject Advance Authorization have already been ratified by NC-3 in its Meeting No. 2/AM20 dated 21.06.2019 (Case No. B-6).
46
|
Case No.:241/15/82- |
|
Party Name:VIRCHOW |
|
Meet No/Date:7/82- |
|
Status: |
|
ALC4/2018 |
|
PETROCHEMICAL PVT LTD. |
|
ALC4/2019 |
|
Withdrawn |
|
|
|
|
|
06.09.2019 |
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910063942 |
|
|
|
:01/82/050/01698/AM19/ |
|
:09/24/040/00036/AM17/ |
|
18.07.2016 |
|
|
Decision: The Committee considered the case as per agenda in the presence of technical experts and it was observed that the norms for the subject Advance Authorization have already been ratified by NC-3 in its Meeting No. 2/AM20 dated 21.06.2019 (Case No. B-6).
, the Committee decided to withdraw the case.
14
47
|
Case No.:243/15/82- |
|
Party Name:VIRCHOW |
|
Meet No/Date:7/82- |
|
Status: |
|
ALC4/2018 |
|
PETROCHEMICAL PVT LTD. |
|
ALC4/2019 |
|
Withdrawn |
|
|
|
|
|
06.09.2019 |
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910063968 |
|
|
|
:01/82/050/01700/AM19/ |
|
:09/24/040/00081/AM17/ |
|
22.07.2016 |
|
|
Decision: The Committee considered the case as per agenda in the presence of technical experts and it was observed that the norms for the subject Advance Authorization have already been ratified by NC-3 in its Meeting No. 2/AM20 dated 21.06.2019 (Case No. B-6).
, the Committee decided to withdraw the case.
|
|
Case No.:244/15/82- |
|
Party Name:VIRCHOW |
|
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
PETROCHEMICAL PVT LTD. |
|
|
ALC4/2019 |
|
Withdrawn |
|
|
|
|
|
|
|
06.09.2019 |
|
|
|
|
HQ File |
|
RLA File |
|
|
Lic.No/Date:0910063969 |
|
|
| 48 |
|
:01/82/050/01701/AM19/<br>:09/24/040/00079/AM17/<br>**Decision:**The Committee considered the case as per agenda |
|
|
22.07.2016<br>in the presence of technical |
|
|
|
experts and it |
|
|
was observed that the norms for the subject Advance Authorization have already been ratified |
|
|
|
|
|
by NC-3 in its |
|
|
|
Meeting No. 2/AM20 dated 21.06.2019 (Case No. B-6). |
|
|
|
|
|
|
|
|
|
In view of above,the Committee decided towithdrawthe case. |
|
|
|
|
|
|
|
|
|
Case No.:245/15/82- |
Party Name:VIRCHOW |
|
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
PETROCHEMICAL PVT LTD. |
|
|
ALC4/2019 |
|
Withdraw |
|
|
|
|
|
|
06.09.2019 |
|
|
|
|
HQ File |
RLA File |
|
|
Lic.No/Date:0910063970 |
|
|
| 49 |
|
:01/82/050/01702/AM19/<br>:09/24/040/00082/AM17/<br>**Decision:**The Committee considered the case as per agenda |
|
22.07.2016<br>in the presence of technical |
|
|
experts and it |
|
|
|
was observed that the norms for the subject Advance Authorization have already been ratified |
|
|
|
|
by NC-3 in its |
|
|
|
Meeting No. 2/AM20 dated 21.06.2019 (Case No. B-6). |
|
|
|
|
|
|
|
|
In view of above,the Committee decided towithdrawthe case. |
|
|
|
|
|
|
Decision: The Committee considered the case as per agenda in the presence of technical experts and it was observed that the norms for the subject Advance Authorization have already been ratified by NC-3 in its Meeting No. 2/AM20 dated 21.06.2019 (Case No. B-6).
| Case No.:485/15/82- |
|
Party Name:DR. ACHARYA |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
LABORATORIES PVT. LTD., |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310807116 |
|
|
| :01/82/050/01942/AM19/ |
|
:03/94/040/00376/AM17/ |
|
12.08.2016 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 2/82-ALC4/2018 dated 16.05.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: 50
| Export Product |
Qty. |
Sl. |
Import Items |
Qty. |
|
|
No. |
|
|
| 2-Methoxy-6-chlorotoluene/ 3-Chloro-2- |
1 kg |
1 |
3-Chloro-2-methylaniline |
1.20 kg |
| methylanisole |
|
|
CAS No.: 87-60-5 |
|
| CAS No.:3260-88-6 |
|
2 |
Sodium nitrite |
0.587 kg |
|
|
|
CAS No.: 7632-00-0 |
|
RA may take appropriate action as per the decision of Norms Committee.
15
| Case No.:479/15/82- |
|
Party Name:WINTAC |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
LIMITED, |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710110298 |
|
|
| :01/82/050/01936/AM19/ |
|
:07/24/040/00159/AM17/ |
|
22.08.2016 |
|
|
|
|
|
|
|
|
Case No.:479/15/82-<br>ALC4/2018 |
Party Name:WINTAC<br>LIMITED, |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/01936/AM19/ |
RLA File<br>:07/24/040/00159/AM17/ |
Lic.No/Date:0710110298<br>22.08.2016 |
|
| 51 |
**Decision:**The Committee considered case as per agenda and in the presence of the technical experts, it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Gylcopyrrolate Injection<br>USP 0.2mg/ml 5ml 253640.000<br>VIALS<br>253640 Number<br>1<br>Gray Westar Rubber<br>Stoppers 20MM<br>S-127 4432/50 GRY<br>B2-42<br>Relevant as<br>per Packing<br>Policy<br>Gylcopyrrolate Injection<br>USP 0.2mg/ml 20ml 22572.000<br>VIALS<br>22572 Number<br>1<br>Gray Westar Rubber<br>Stoppers 20MM<br>S-127 4432/50 GRY<br>B2-42<br>Relevant as<br>per Packing<br>Policy<br>Dexamethasone Sodium Phosphate<br>Injection<br>SP 4mg/ml 30ml (20mm)<br>225000.000 VIALS<br>225000 Number<br>1<br>Gray Westar Rubber<br>Stoppers 20MM<br>S-127 4432/50 GRY<br>B2-42<br>Relevant as<br>per Packing<br>Policy<br>Naloxone Hydrochloride Injection<br>USP (0.4mg/ml) 10ml 53412.000<br>VIALS<br>53412 Number<br>1<br>Dark Grey<br>Bromobutyl Rubber<br>Stopper 20MM<br>V9048 FM457/0<br>Relevant as<br>per Packing<br>Policy<br>Note : The above norms are subject to verification of DML by RLA, Bangalolre for the above<br>export products..<br>RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
| Case No.:495/15/82- |
|
Party Name:WINTAC |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
LIMITED, |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710110299 |
|
|
| :01/82/050/01952/AM19/ |
|
:07/24/040/00165/AM17/ |
|
22.08.2016 |
|
|
|
Case No.:495/15/82-<br>ALC4/2018 |
Case No.:495/15/82-<br>ALC4/2018 |
Party Name:WINTAC<br>LIMITED, |
Party Name:WINTAC<br>LIMITED, |
Party Name:WINTAC<br>LIMITED, |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/01952/AM19/ |
|
RLA File<br>:07/24/040/00165/AM17/ |
|
|
Lic.No/Date:0710110299<br>22.08.2016 |
|
| 52 |
**Decision:**The Committee considered case as per agenda and in the presence of the technical experts, it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Gylcopyrrolate<br>Injection<br>USP<br>0.2mg/ml<br>1m<br>380000.000 VIALS<br>380000 Number<br>1<br>SERUM STOPPER 13MM<br>V9239FM259/0 FLCO 015-<br>110010713<br>Relevant as<br>per Packing<br>Policy<br>Gylcopyrrolate<br>Injection<br>USP<br>0.2mg/ml<br>2ml<br>380000.000 VIALS<br>380000 Number<br>1<br>SERUM STOPPER 13MM<br>V9239FM259/0 FLCO 015-<br>110010713<br>Relevant as<br>per Packing<br>Policy<br>Dexamethasone Sodium<br>Phosphate Injection USP<br>10mg/ml 1ml 250000.000<br>VIALS<br>250000 Number<br>1<br>Gray Westar Rubber Stoppers<br>13MM<br>V-35 4432/50<br>Relevant as<br>per Packing<br>Policy |
|
|
|
|
|
|
|
Export product |
Qty. |
|
Sl.<br>No. |
Import items |
|
Qty. |
|
Gylcopyrrolate<br>Injection<br>USP<br>0.2mg/ml<br>1m<br>380000.000 VIALS |
380000 Number |
|
1 |
SERUM STOPPER 13MM<br>V9239FM259/0 FLCO 015-<br>110010713 |
|
Relevant as<br>per Packing<br>Policy |
|
Gylcopyrrolate<br>Injection<br>USP<br>0.2mg/ml<br>2ml<br>380000.000 VIALS |
380000 Number |
|
1 |
SERUM STOPPER 13MM<br>V9239FM259/0 FLCO 015-<br>110010713 |
|
Relevant as<br>per Packing<br>Policy |
|
Dexamethasone Sodium<br>Phosphate Injection USP<br>10mg/ml 1ml 250000.000<br>VIALS |
250000 Number |
|
1 |
Gray Westar Rubber Stoppers<br>13MM<br>V-35 4432/50 |
|
Relevant as<br>per Packing<br>Policy |
Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
16
|
Dexamethasone Sodium<br>Phosphate Injection |
2080000<br>Number |
2080000<br>Number |
1 |
Gray Westar Rubber Stoppers<br>13MM |
Gray Westar Rubber Stoppers<br>13MM |
Relevant as<br>per Packing |
Relevant as<br>per Packing |
|
|
<br>USP 4mg/ml 1ml<br>2080000.000 VIALS |
|
|
|
<br>V-35 |
<br>4432/50 |
<br> |
<br>Policy |
|
|
Dexamethasone Sodium<br>Phosphate Injection<br>USP 4mg/ml 5ml<br>800000.000 VIALS |
8 |
00000Number |
1 |
Gray |
Westar Rubber Stoppers |
|
Relevant as |
|
|
|
|
|
|
13M<br>V-35 |
M<br>4432/50 |
p<br> |
er Packing<br>Policy |
|
|
|
|
|
|
|
|
|
|
|
|
Cyanocobalamin Injection<br>USP ,100 mcg/ml 1ml |
1000000Number |
|
1 |
Gray Westar Rubber Stoppers<br>13MM |
|
Relevant as<br>per Packing |
|
|
|
<br>1000000.000 VIALS |
|
|
|
V-35 4432/50 |
|
<br>Policy |
|
|
|
Naloxone Hydrochloride |
200000Number |
|
1 |
Bromobutyl Rubber Stoppers |
|
Relevant as |
|
|
|
Injection<br>USP (0.4mg/ml) 1ml<br>200000.000 VIALS |
|
|
|
(RFS)<br>Grey |
13MM<br>V9024 FM457/0 |
p<br> |
er Packing<br>Policy |
|
|
Note : The above norms are<br>export products.. |
|
|
|
|
|
|
|
|
|
|
|
subject to verification of DM |
|
|
by RLA, Bangalolre for |
|
the above |
|
|
RA maytake appropriate action a |
|
sper the decision of Norms Com |
|
|
mittee |
|
|
|
|
|
|
|
|
|
|
|
|
|
RA may take appropriate action as per the decision of Norms Committee
| Case No.:516/15/82- |
|
Party Name:BELOOR BAYIR |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
BIOTECH LTD, |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710110335 |
|
Defer Date |
| :01/82/050/01973/AM19/ |
|
:07/24/040/00182/AM17/ |
|
30.08.2016 |
|
|
Decision: RLA, Bangalore was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07 application of subject Advance Authorization. Application is still awaited from RLA Bangalore. Hence, it was decided to issue a Reminder to RLA, Bangalore for furnishing a copy of 4.07 application of subject 53 Advance Authorization expeditiously. Further, it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 2/82-ALC4/2019 dated 21.06.2019, followed by reminder on 01.08.2019:
(i) Approved Composition / DML from the competent authority showing composition of each export product.
In view of above, the Committee decided to issue Final Reminder to firm giving 15 days time to furnish its reply, failing which the case will be rejected.
| Case No.:253/15/82- |
|
Party Name:ACULIFE |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
HEALTHCARE PRIVATE |
|
ALC4/2019 |
|
Rejected |
|
|
LIMITED, |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0810138644 |
|
|
| :01/82/050/01710/AM19/ |
|
:08/24/040/00158/AM17/ |
|
12.09.2016 |
|
|
54 Decision: The Committee considered the case as per agenda and it was observed that one of the import items namely Soyabean Oil having ITC HS – 15079090 comes under Chapter 15 and as per para 4.11 (A) (i) of the FTP 2015-20 , all vegetable / edible oils classified under Chapter 15 of ITC (HS) are ineligible for import on self- declaration basis under para 4.07 of the FTP.
In view of above, the Committee decided to reject the case.
17
| Case No.:254/15/82- |
|
Party Name:ACULIFE |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
HEALTHCARE PRIVATE |
|
ALC4/2019 |
|
Rejected |
|
|
LIMITED, |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0810138645 |
|
|
| :01/82/050/01711/AM19/ |
|
:08/24/040/00159/AM17/ |
|
12.09.2016 |
|
|
55 Decision: The Committee considered the case as per agenda and it was observed that one of the import items namely Soyabean Oil having ITC HS – 15079090 comes under Chapter 15 and as per para 4.11 (A) (i) of the FTP 2015-20 , all vegetable / edible oils classified under Chapter 15 of ITC (HS) are ineligible for import on self- declaration basis under para 4.07 of the FTP.
, the Committee decided to reject the case.
| Case No.:255/15/82- |
|
Party Name:ACULIFE |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
HEALTHCARE PRIVATE |
|
ALC4/2019 |
|
Rejected |
|
|
LIMITED, |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0810138646 |
|
|
| :01/82/050/01712/AM19/ |
|
:08/24/040/00164/AM17/ |
|
12.09.2016 |
|
|
56 Decision: The Committee considered the case as per agenda and it was observed that one of the import items namely Soyabean Oil having ITC HS – 15079090 comes under Chapter 15 and as per para 4.11 (A) (i) of the FTP 2015-20 , all vegetable / edible oils classified under Chapter 15 of ITC (HS) are ineligible for import on self- declaration basis under para 4.07 of the FTP.
In view of above, the Committee decided to reject the case.
|
|
Case No.:646/15/82- |
|
Party Name:WINTAC |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
LIMITED, |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 57 |
|
HQ File<br>:01/82/050/02103/AM19/ |
|
RLA File<br>:07/24/040/00251/AM17/ |
|
Lic.No/Date:0710110596<br>28.10.2016 |
|
Defer Date |
|
|
**Decision:**The Committee |
|
noted that the 4.07 application of subject Advance Authorization is not |
|
|
|
|
|
|
available. Hence, it was decided |
to call for a copy of 4.07 application of the subject advance |
|
|
|
authorization |
|
|
|
from RLA Bangalore. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Bangalore.
| Case No.:679/15/82- |
|
Party Name:BELOOR BAYIR |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
BIOTECH LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710110770 |
|
Defer Date |
| :01/82/050/02136/AM19/ |
|
:07/24/040/00273/AM17/ |
|
09.12.2016 |
|
|
Decision: RLA, Bangalore was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07 application of subject Advance Authorization. Application is still awaited from RLA Bangalore. Hence, it 58 was decided to issue a Reminder to RLA, Bangalore for furnishing a copy of 4.07 application of subject Advance Authorization expeditiously. Further, it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 2/82-ALC4/2019 dated 21.06.2019, followed by reminder on 01.08.2019:
(i) Approved Composition / DML from the competent authority showing composition of each export product. In view of above, the Committee decided to issue Final Reminder to firm giving 15 days time to furnish its reply, failing which the case will be rejected.
18
| 59 |
Case No.:271/15/82-<br>ALC4/2018 |
Party Name:ARKRAY<br>HEALTHCARE PVT.LTD. |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/01728/AM19/ |
RLA File<br>:52/24/040/00052/AM17/ |
Lic.No/Date:5210042097<br>14.12.2016 |
|
|
**Decision:**The Committee<br>available. Hence, it was decided<br>from RLA Surat. |
noted that the 4.07 application of subject Advance Authorization is not<br>to call for a copy of 4.07 application of the subject advance authorization |
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Surat.
| 60 |
Case No.:680/15/82-<br>ALC4/2018 |
Party Name:WINTAC<br>LIMITED, |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02137/AM19/ |
RLA File<br>:07/24/040/00282/AM17/ |
Lic.No/Date:0710110805<br>16.12.2016 |
|
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA Bangalore. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Bangalore.
| 61 |
Case No.:265/15/82-<br>ALC4/2018 |
Party Name:ATUL LIMITED, |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/01722/AM19/ |
RLA File<br>:08/24/040/00374/AM17/ |
Lic.No/Date:0810139395<br>28.12.2016 |
|
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA Ahmedabad. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Ahmedabad.
| Case No.:413/15/82- |
|
Party Name:SHREE GANESH |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
REMEDIES PVT.LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410042826 |
|
|
| :01/82/050/01870/AM19/ |
|
:34/24/040/00293/AM17/ |
|
10.01.2017 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: 62
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| Di Methyl Amino Propyl Chloride<br>Hydrochloride-65% Solution in Water<br>(DMPC-65%) |
1 kg |
1 |
1-Bromo-3-Chloro Propane |
0.72 kg |
RA may take appropriate action as per the decision of Norms Committee.
19
| Case No.:414/15/82-<br>Party Name:TATVA |
|
|
|
Meet No/Date:7/82- |
|
|
Status: |
|
| ALC4/2018<br>CHINTAN PHARMA CHEM |
|
|
|
ALC4/2019 |
|
|
Approved |
|
| PVT LTD |
|
|
|
06.09.2019 |
|
|
|
|
| HQ File<br>RLA File |
|
|
|
Lic.No/Date:3410042875 |
|
|
|
|
| :01/82/050/01871/AM19/<br>:34/24/040/00291/AM17/ |
|
|
|
20.01.2017 |
|
|
|
|
| **Decision:**The Committee considered the case as per |
agenda in the presence of Technical Experts and |
|
|
|
|
|
|
|
| in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by<br>NC |
|
<br>in |
|
<br>its<br>Meeting<br>No. |
3/82-ALC4/2019 |
|
|
|
| , dated 05.07.2019, it was decided to ratify the ad-hoc input output norms under para 4.7<br>per details below or as applied by firm whichever is lower: |
|
|
|
|
of HBP Vol. I as |
|
|
|
| Export product<br>Qty.<br>Sl. |
|
Import items |
|
|
|
|
Qty. |
|
| No. |
|
|
|
|
|
|
|
|
| METHYL TRIPHENYL PHOSPHONIUM<br>1 kg<br>1 |
|
TRIPHENYL<br>PHOSPHINE |
|
|
|
|
0.78 kg |
|
| BROMIDE |
|
CAS |
|
NO: 603-35-0 ASSAY NLT |
|
|
|
|
| CAS No.1779-49-3 ASSAY NLT 98% |
|
98% |
|
|
|
|
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 3/82-ALC4/2019 , dated 05.07.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as 63 per details below or as applied by firm whichever is lower:
|
|
Case No.:992/15/82- |
|
Party Name:WINTAC |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
LIMITED, |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 64 |
|
HQ File<br>:01/82/050/02449/AM19/ |
|
RLA File<br>:07/24/040/00353/AM17/ |
|
Lic.No/Date:0710111032<br>27.01.2017 |
|
Defer Date |
|
|
**Decision:**The Committee |
|
noted that the 4.07 application |
of subject Advance Authorization is not |
|
|
|
|
|
available. Hence, it was decided |
to call for a copy of 4.07 application of the subject advance |
|
|
|
authorization |
|
|
|
from RLA Bangalore. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Bangalore.
| Case No.:993/15/82- |
|
Party Name:WINTAC |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
LIMITED, |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710111042 |
|
|
| :01/82/050/02450/AM19/ |
|
:07/24/040/00351/AM17/ |
|
31.01.2017 |
|
|
|
|
**Decision:**The Committee considered case as per agenda and in |
**Decision:**The Committee considered case as per agenda and in |
**Decision:**The Committee considered case as per agenda and in |
the presence of the technical experts, it |
the presence of the technical experts, it |
the presence of the technical experts, it |
the presence of the technical experts, it |
|
|
was decided to ratify the ad-hoc input output |
norms under para 4.7 |
|
of HBP as per details below or as applied |
|
|
|
|
|
by firm whichever is lower: |
|
|
|
|
|
|
|
|
Exportproduct |
Qty. |
Sl. No. |
Import items |
|
Qty. |
|
|
|
Glycopyrrolate Injection |
3483000 |
1 |
SERUM STOPPER |
|
Relevant as |
|
| 65 |
|
USP 0.2mg/ml 1mL (3483000 Vials) |
Number |
|
13MM |
|
per Packing |
|
|
|
|
|
|
V9239FM259/0 FLCO<br>015-110010713 |
|
Policy |
|
|
|
Glycopyrrolate Injection |
1451250 |
1 |
SERUM STOPPER |
|
Relevant as |
|
|
|
USP 0.2mg/ml 2ml (1451250 Vials) |
Number |
|
13MM |
|
per Packing |
|
|
|
|
|
|
V9239FM259/0 FLCO<br>015-110010713 |
|
Policy |
|
|
|
Cyanocobalamin Injection |
6200000 |
1 |
Gray Westar Rubber |
|
Relevant as |
|
|
|
USP ,1000 mcg/ml 1mL (6200000 Vials) |
Number |
|
Stoppers 13MM |
|
per Packing |
|
|
|
|
|
|
V-35 4432/50 |
|
Policy |
|
|
|
Note: The above norms are subject to |
verification of DML by RLA, Bangalolre |
|
|
for the above |
|
|
|
|
exportproducts. |
|
|
|
|
|
|
|
|
RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
20
| Case No.:994/15/82- |
|
Party Name:WINTAC |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
LIMITED, |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710111043 |
|
|
| :01/82/050/02451/AM19/ |
|
:07/24/040/00352/AM17/ |
|
31.01.2017 |
|
|
|
|
ALC4/2018<br>LIMITED,<br>HQ File<br>:01/82/050/02451/AM19/<br>RLA File<br>:07/24/040/00352/AM17/ |
ALC4/2018<br>LIMITED,<br>HQ File<br>:01/82/050/02451/AM19/<br>RLA File<br>:07/24/040/00352/AM17/ |
ALC4/2018<br>LIMITED,<br>HQ File<br>:01/82/050/02451/AM19/<br>RLA File<br>:07/24/040/00352/AM17/ |
ALC4/2019<br>06.09.2019<br>Approved<br>Lic.No/Date:0710111043<br>31.01.2017 |
ALC4/2019<br>06.09.2019<br>Approved<br>Lic.No/Date:0710111043<br>31.01.2017 |
ALC4/2019<br>06.09.2019<br>Approved<br>Lic.No/Date:0710111043<br>31.01.2017 |
|
|
**Decision:**The Committee considered case as per agenda and |
|
|
in the presence of the technical experts, it |
|
|
|
|
was decided to ratify the ad-hoc input output norms under para |
|
|
4.7 of HBP as per details below or as applied |
|
|
|
|
by firm whichever is lower: |
|
|
|
|
|
|
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
| 66 |
|
|
|
No. |
|
|
|
|
|
Glycopyrrolate Injection |
812700 Number |
1 |
Gray Westar Rubber |
Relevant as |
|
|
|
USP 0.2mg/ml 5ml |
|
|
Stoppers 20MM |
per Packing |
|
|
|
|
|
|
S 127 4432/50 GRY<br>B2-42 |
Policy |
|
|
|
Glycopyrrolate Injection |
58050 Number |
1 |
Gray Westar Rubber |
Relevant as |
|
|
|
USP 0.2mg/ml 20ml |
|
|
Stoppers 20MM |
per Packing |
|
|
|
|
|
|
S 127 4432/50 GRY<br>B2-42 |
Policy |
|
|
|
Note: The above norms are subject to verification of DML by RLA, Bangalolre for the above |
|
|
|
|
|
|
|
exportproducts. |
|
|
|
|
|
|
|
RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
|
|
Case No.:374/15/82- |
|
Party Name:GLAND PHARMA |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 67 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910064653 |
|
Defer Date |
|
|
:01/82/050/01831/AM19/ |
|
:09/24/040/00594/AM17/ |
|
07.02.2017 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
| Case No.:360/15/82- |
|
Party Name:MAHIMA LIFE |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
SCIENCES PVT.LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510401593 |
|
|
| :01/82/050/01817/AM19/ |
|
:05/24/040/00565/AM17/ |
|
09.02.2017 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as 0per details below or as 68 applied by firm whichever is lower:
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
No. |
|
|
|
METHYL PREDNISOLONE |
1 kg |
1 |
11 BETA 17 ALPHA DIHYDROXY-6 |
1.313 kg |
|
|
|
|
ALPHA METHYL PREGNA-1, 4- |
|
|
|
|
|
DIENE-3, 20-DIONE |
|
| RA maytake appropriate action asper the decision |
|
|
|
of Norms Committee. |
|
21
| 69 |
Case No.:995/15/82-<br>ALC4/2018 |
Party Name:WINTAC<br>LIMITED, |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/02452/AM19/ |
RLA File<br>:07/24/040/00362/AM17/ |
Lic.No/Date:0710111117<br>10.02.2017 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA Bangalore. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Bangalore.
| Case No.:1001/15/82- |
|
Party Name:BELOOR BAYIR |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
BIOTECH LTD, |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710111126 |
|
Defer Date |
| :01/82/050/02458/AM19/ |
|
:07/24/040/00374/AM17/ |
|
14.02.2017 |
|
|
Decision: RLA, Bangalore was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07 application of subject Advance Authorization. Application is still awaited from RLA Bangalore. Hence, it was decided to issue a Reminder to RLA, Bangalore for furnishing a copy of 4.07 application of subject 70 Advance Authorization expeditiously. Further, it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 2/82-ALC4/2019 dated 21.06.2019, followed by reminder on 01.08.2019:
(i) Approved Composition / DML from the competent authority showing composition of each export product.
In view of above, the Committee decided to issue Final Reminder to firm giving 15 days time to furnish its reply, failing which the case will be rejected.
|
|
Case No.:1002/15/82- |
|
Party Name:WINTAC |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
LIMITED, |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 71 |
|
HQ File<br>:01/82/050/02459/AM19/ |
|
RLA File<br>:07/24/040/00365/AM17/ |
|
Lic.No/Date:0710111160<br>21.02.2017 |
|
Defer Date |
|
|
**Decision:**The Committee |
|
noted that the 4.07 application of subject Advance Authorization is not |
|
|
|
|
|
|
available. Hence, it was decided |
to call for a copy of 4.07 application of the subject advance |
|
|
|
authorization |
|
|
|
from RLA Bangalore. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Bangalore.
|
|
Case No.:276/15/82- |
|
Party Name:JODAS EXPOIM |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
PVT.LTD., |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 72 |
|
HQ File<br>:01/82/050/01733/AM19/ |
|
RLA File<br>:05/23/040/00561/AM17/ |
|
Lic.No/Date:0510401758<br>22.02.2017 |
|
Defer Date |
|
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not |
|
|
|
|
|
|
|
|
available. Hence, it was decided |
to call for a copy of 4.07 application of the subject advance |
|
|
|
authorization |
|
|
|
from CLA New Delhi. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA New Delhi.
22
| 73 |
Case No.:277/15/82-<br>ALC4/2018 |
Party Name:ARKRAY<br>HEALTHCARE PVT.LTD. |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/01734/AM19/ |
RLA File<br>:52/24/040/00079/AM17/ |
Lic.No/Date:5210042190<br>01.03.2017 |
|
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA Surat. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Surat.
| 74 |
Case No.:1007/15/82-<br>ALC4/2018 |
Party Name:MEDREICH<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02464/AM19/ |
RLA File<br>:07/24/040/00396/AM17/ |
Lic.No/Date:0710111261<br>09.03.2017 |
|
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA Bangalore. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Bangalore.
| Case No.:1020/15/82- |
|
Party Name:PREMIER |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
INDUSTRIES |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:5010002343 |
|
|
| :01/82/050/02477/AM19/ |
|
:50/24/040/00017/AM17/ |
|
31.03.2017 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as 0per details below or as 75 applied by firm whichever is lower:
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
No. |
|
|
|
|
PARACHLORO ORTHO |
1 kg |
1 |
PARADICHLORO BENZENE(PDCB) |
0.894 kg |
|
|
NITRO ANILINE (P.C.O.N.A) |
|
|
|
|
|
|
2,5-DICHLORONITRO |
1 kg |
1 |
PARADICHLORO BENZENE(PDCB) |
0.797 kg |
|
|
BENZENE(2,5-D.C.N.B.) |
|
|
|
|
|
| RA maytake appropriate action asper the decision |
|
|
|
of Norms Committee. |
|
|
| 76 |
Case No.:293/15/82-<br>ALC4/2018 |
Party Name:ARKRAY<br>HEALTHCARE PVT.LTD. |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br> <br><br>Lic.No/Date:5210042239<br>25.04.2017<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01750/AM19/ |
RLA File<br>:52/24/040/00002/AM18/ |
|
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA Surat. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Surat.
23
|
|
Case No.:294/15/82- |
|
Party Name:SUPREET |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
CHEMICALS PVT.LTD. |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 77 |
|
HQ File<br>:01/82/050/01751/AM19/ |
|
RLA File<br>:52/24/040/00006/AM18/ |
|
Lic.No/Date:5210042249<br>02.05.2017 |
|
Defer Date |
|
|
**Decision:**The Committee |
|
noted that the 4.07 application |
of subject Advance Authorization is not |
|
|
|
|
|
available. Hence, it was decided |
to call for a copy of 4.07 application of the subject advance |
|
|
|
authorization |
|
|
|
from RLA Surat. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Surat.
|
|
Case No.:282/15/82- |
|
Party Name:MSN |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
PHARMACHEM PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
06.09.2019 |
|
|
| 78 |
|
HQ File<br>:01/82/050/01739/AM19/ |
|
RLA File<br>:09/24/040/00067/AM18/ |
|
Lic.No/Date:0910065021<br>11.05.2017 |
|
Defer Date |
|
|
**Decision:**The Committee |
|
noted that the 4.07 application of subject Advance Authorization is not |
|
|
|
|
|
|
available. Hence, it was decided |
to call for a copy of 4.07 application of the subject advance |
|
|
|
authorization |
|
|
|
from RLA Hyderabad. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Hyderabad.
| Case No.:289/15/82- |
|
Party Name:ATUL LIMITED, |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
|
|
ALC4/2019 |
|
Deferred |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0810140311 |
|
Defer Date |
| :01/82/050/01746/AM19/ |
|
:08/24/040/00043/AM18/ |
|
18.05.2017 |
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not 79 available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Ahmedabad.
Further, the Committee considered the case as per online agenda and it was decided to call for following information from the firm:
(i) Complete 4E with all technical details i.e chemistry, molecular weight, stoichiometric reaction and % of yield on molar basis at every stage.
|
|
Case No.:392/15/82- |
|
Party Name:ALEMBIC |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
PHARMACEUTICALS LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 80 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:3410043214 |
|
Defer Date |
|
|
:01/82/050/01849/AM19/ |
|
:34/24/040/00034/AM18/ |
|
22.05.2017 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
24
| Case No.:395/15/82- |
|
Party Name:GULBRANDSEN |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
CHEMICALS PVT LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410043212 |
|
|
| :01/82/050/01852/AM19/ |
|
:34/24/040/00039/AM18/ |
|
22.05.2017 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 25/82-ALC4/2012 dated 29.11.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as 81 per details given below or as applied by the firm, whichever is less:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| G Coat H 110 |
1 kg |
1 |
Tin Ingots |
0.487 kg |
|
|
2 |
Aluminium Grit/Granules |
0.060 kg |
|
|
3 |
Butene-1 |
0.442 kg |
RA may take appropriate action as per the decision of Norms Committee.
| 82 |
Case No.:290/15/82-<br>ALC4/2018 |
Party Name:WINTAC<br>LIMITED,<br>RLA File<br>:07/24/040/00052/AM18/ |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/01747/AM19/ |
|
Lic.No/Date:0710111636<br>23.05.2017 |
|
|
**Decision:**The Committee<br>available. Hence, it was decided<br>from RLA Bangalore. |
noted that the 4.07 application of subject Advance Authorization is not<br>to call for a copy of 4.07 application of the subject advance authorization |
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Bangalore.
| 83 |
Case No.:291/15/82-<br>ALC4/2018 |
Party Name:WINTAC<br>LIMITED, |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br> <br><br>Lic.No/Date:0710111650<br>24.05.2017<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01748/AM19/ |
RLA File<br>:07/24/040/00056/AM18/ |
|
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA Bangalore. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Bangalore.
| 84 |
<br>Case No.:296/15/82-<br>ALC4/2018 |
Party Name:MICRO LABS<br>LTD<br>RLA File<br>:07/24/040/00082/AM18/ |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/01753/AM19/ |
|
Lic.No/Date:0710111725<br>08.06.2017 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
| 85 |
<br>Case No.:525/4/82-ALC4/2017 |
Party Name:CIPLA LIMITED. |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
25
| HQ File |
|
RLA File |
|
Lic.No/Date:0310813980 |
|
Defer Date |
| :01/82/050/00533/AM18/ |
|
:03/94/040/00211/AM18/ |
|
14.06.2017 |
|
|
Decision: Deferred for comments of TE.
| Case No.:299/15/82- |
|
Party Name:CADILA |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
PHARMACEUTICALS LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0810140567 |
|
|
| :01/82/050/01756/AM19/ |
|
:08/24/040/00094/AM18/ |
|
28.06.2017 |
|
|
|
|
ALC4/2018<br>PHARMACEUTICALS LTD.<br>ALC4/2019<br>06.09.2019<br>Approved<br>HQ File<br>:01/82/050/01756/AM19/<br>RLA File<br>:08/24/040/00094/AM18/<br>Lic.No/Date:0810140567<br>28.06.2017 |
ALC4/2018<br>PHARMACEUTICALS LTD.<br>ALC4/2019<br>06.09.2019<br>Approved<br>HQ File<br>:01/82/050/01756/AM19/<br>RLA File<br>:08/24/040/00094/AM18/<br>Lic.No/Date:0810140567<br>28.06.2017 |
ALC4/2018<br>PHARMACEUTICALS LTD.<br>ALC4/2019<br>06.09.2019<br>Approved<br>HQ File<br>:01/82/050/01756/AM19/<br>RLA File<br>:08/24/040/00094/AM18/<br>Lic.No/Date:0810140567<br>28.06.2017 |
ALC4/2018<br>PHARMACEUTICALS LTD.<br>ALC4/2019<br>06.09.2019<br>Approved<br>HQ File<br>:01/82/050/01756/AM19/<br>RLA File<br>:08/24/040/00094/AM18/<br>Lic.No/Date:0810140567<br>28.06.2017 |
ALC4/2018<br>PHARMACEUTICALS LTD.<br>ALC4/2019<br>06.09.2019<br>Approved<br>HQ File<br>:01/82/050/01756/AM19/<br>RLA File<br>:08/24/040/00094/AM18/<br>Lic.No/Date:0810140567<br>28.06.2017 |
ALC4/2018<br>PHARMACEUTICALS LTD.<br>ALC4/2019<br>06.09.2019<br>Approved<br>HQ File<br>:01/82/050/01756/AM19/<br>RLA File<br>:08/24/040/00094/AM18/<br>Lic.No/Date:0810140567<br>28.06.2017 |
ALC4/2018<br>PHARMACEUTICALS LTD.<br>ALC4/2019<br>06.09.2019<br>Approved<br>HQ File<br>:01/82/050/01756/AM19/<br>RLA File<br>:08/24/040/00094/AM18/<br>Lic.No/Date:0810140567<br>28.06.2017 |
|
|
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in |
|
|
|
|
|
|
|
|
meeting no. 5/82-ALC4/2019 dated |
02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as |
|
|
|
|
|
|
|
per details given below or as applied |
|
by the firm, whichever is less: |
|
|
|
|
|
|
Export product |
|
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
|
|
No. |
|
|
|
| 86 |
|
AZITHROMYCIN CAPSULES |
|
1 Number |
1 |
AZITHROMYCIN |
267.256 mg / 250 |
|
|
|
250MG ( EACH CAPSULES |
|
|
|
DIHYDRATE PH |
mg capsule |
|
|
|
CONTAINS<br>NET<br>250MG |
|
|
|
EUR |
|
|
|
|
AZITHROMYCIN |
|
|
|
|
|
|
|
|
DIHYDRATE<br>PH<br>EUR<br>) |
|
|
|
|
|
|
|
|
(<br>EACH<br>CAPSULES |
|
|
|
|
|
|
|
|
REQUIRED<br>267.256<br>MG |
|
|
|
|
|
|
|
|
INCLUDING<br>WASTAGE |
|
|
|
|
|
|
|
|
TOTAL<br>CONTAINS<br>OF<br>IS |
|
|
|
|
|
|
|
|
105.566 KGS) |
|
|
|
|
|
|
|
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
|
|
Case No.:300/15/82- |
|
Party Name:SRIAM LABS |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
PRIVATE LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 87 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910065229 |
|
Defer Date |
|
|
:01/82/050/01757/AM19/ |
|
:09/24/040/00145/AM18/ |
|
29.06.2017 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:571/15/82- |
|
Party Name:SRIAM LABS |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
PRIVATE LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 88 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910065242 |
|
Defer Date |
|
|
:01/82/050/02028/AM19/ |
|
:09/24/040/00158/AM18/ |
|
06.07.2017 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:309/15/82- |
|
Party Name:DISCOVERY |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
INTERMEDIATES PVT LTD. |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 89 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910065252 |
|
Defer Date |
|
|
:01/82/050/01766/AM19/ |
|
:09/24/040/00157/AM18/ |
|
07.07.2017 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
26
| 90 |
Case No.:301/15/82-<br>ALC4/2018 |
Party Name:MEDREICH<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01758/AM19/ |
RLA File<br>:07/24/040/00111/AM18/ |
Lic.No/Date:0710111877<br>13.07.2017 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA Bangalore. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Bangalore.
| Case No.:5/5/80-ALC2/2018 |
|
Party Name:TEENA LABS |
|
Meet No/Date:7/82- |
|
Status: |
|
|
LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910065275 |
|
|
| :01/80/050/00054/AM19/ |
|
:09/24/040/00182/AM18/ |
|
17.07.2017 |
|
|
Decision: The Committee considered case as per agenda and as per earlier decision taken by NC in its 13/82-ALC4/2018 meeting dated 14.01.2019, it was decided to ratify the ad-hoc input output norms under 91 para 4.7 of HBP as per details below or as applied by firm whichever is lower:-
| Export product<br>PIPERACILLIN AND TAZOBACTOM<br>FOR INJECTION 8:1 USP |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
|
1 kg |
1 |
PIPERACILLIN ACID |
0.891 kg |
|
|
2 |
TAZOBACTAM ACID |
0.109 kg |
RA concerned may take further necessary action as per above decision of NC
| 92 |
<br>Case No.:305/15/82-<br>ALC4/2018 |
Party Name:MEDREICH<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01762/AM19/ |
RLA File<br>:07/24/040/00115/AM18/ |
Lic.No/Date:0710111888<br>18.07.2017 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
| 93 |
Case No.:306/15/82-<br>ALC4/2018 |
Party Name:MEDREICH<br>LIMITED<br>RLA File<br>:07/24/040/00116/AM18/ |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br> <br><br>Lic.No/Date:0710111889<br>18.07.2017<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01763/AM19/ |
|
|
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA Bangalore. |
|
|
|
| 94 |
Case No.:311/15/82-<br>ALC4/2018 |
Party Name:ASSOCIATED<br>DYESTUFF PVT. LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01768/AM19/ |
RLA File<br>:08/24/040/00123/AM18/ |
Lic.No/Date:0810140725<br>26.07.2017 |
Defer Date |
|
**Decision:**The Committee<br>available. Hence, it was decided<br>from RLA Ahmedabad. |
noted that the 4.07 application of subject Advance Authorization is not<br>to call for a copy of 4.07 application of the subject advance authorization |
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Ahmedabad.
27
| Case No.:402/15/82- |
|
Party Name:TATVA |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
CHINTAN PHARMA CHEM |
|
ALC4/2019 |
|
Approved |
|
|
PVT LTD |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410043365 |
|
|
| :01/82/050/01859/AM19/ |
|
:34/24/040/00103/AM18/ |
|
26.07.2017 |
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 3/82-ALC4/2019 , dated 05.07.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as 95 per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| METHYL TRIPHENYL |
1 kg |
1 |
TRIPHENYL PHOSPHINE |
0.78 kg |
| PHOSPHONIUM BROMIDE |
|
|
CAS NO: 603-35-0 ASSAY |
|
| CAS No. 1779-49-3 ASSAY NLT |
|
|
NLT 98% |
|
| 98% |
|
|
|
|
|
Case No.:314/15/82- |
|
Party Name:WEXFORD |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
LABORATORIES PVT LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
|
| 96 |
HQ File |
|
RLA File |
|
Lic.No/Date:0710111992 |
|
Defer Date |
|
|
:01/82/050/01771/AM19/ |
|
:07/24/040/00120/AM18/ |
|
09.08.2017 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Case No.:315/15/82- |
|
Party Name:MEDREICH |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
|
| 97 |
HQ File |
|
RLA File |
|
Lic.No/Date:0710111997 |
|
Defer Date |
|
|
:01/82/050/01772/AM19/ |
|
:07/24/040/00105/AM18/ |
|
09.08.2017 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Case No.:318/15/82- |
|
Party Name:MYLAN |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
LABORATORIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 98 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910065385 |
|
Defer Date |
|
|
:01/82/050/01775/AM19/ |
|
:09/24/040/00259/AM18/ |
|
24.08.2017 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
28
| 99 |
<br>Case No.:321/15/82-<br>ALC4/2018<br>Party Name:AASHA<br>BIOCHEM<br>Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Status:<br>Deferred<br>HQ File<br>:01/82/050/01778/AM19/<br>RLA File<br>:10/24/040/00018/AM18/<br>Lic.No/Date:1010059805<br>31.08.2017<br>Defer Date<br>**Decision:**The Committee considered the case as per agenda and it was observed that as per<br>manufacturing process, starting raw material is Fish Oil , i.e., (Squalene Oil 80%), falls under Chapter 1504<br>and the licence should not be issued under para 4.07 of HBP Vol. I. Hence, it was decided to call the firm for<br>attendingPersonal Hearingbefore Norms Committee alongwith sample of import and exportproduct. |
Decision: The Committee considered the case as per agenda and it was observed that as per manufacturing process, starting raw material is Fish Oil , i.e., (Squalene Oil 80%), falls under Chapter 1504 and the licence should not be issued under para 4.07 of HBP Vol. I. Hence, it was decided to call the firm for attending Personal Hearing before Norms Committee along with sample of import and export product.
| Case No.:14/5/80-ALC2/2018 |
|
Party Name:TEENA LABS |
|
Meet No/Date:7/82- |
|
Status: |
|
|
LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910065436 |
|
|
| :01/80/050/00063/AM19/ |
|
:09/24/040/00274/AM18/ |
|
07.09.2017 |
|
|
Decision: The Committee considered case as per agenda and as per earlier decision taken by NC in its 13/82-ALC4/2018 meeting dated 14.01.2019, it was decided to ratify the ad-hoc input output norms 100 under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
| Export product |
Export product |
|
Qty. |
Sl.No. |
Import items |
Qty. |
| Piperacillin |
Sodium |
and |
1 Kg. |
1 |
Piperacillin Acid |
0.891 kg |
| Tazobactam<br>(8:1) |
Sodium |
Sterile |
|
2 |
Tazobactam Acid |
0.109 kg |
RA concerned may take further necessary action as per above decision of NC
| 101 |
<br>Case No.:483/15/82-<br>ALC4/2018 |
Party Name:MEDREICH<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01940/AM19/ |
RLA File<br>:07/24/040/00157/AM18/ |
Lic.No/Date:0710112113<br>07.09.2017 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 102 |
Case No.:506/15/82-<br>ALC4/2018 |
Party Name:MEDREICH<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01963/AM19/ |
RLA File<br>:07/24/040/00170/AM18/ |
Lic.No/Date:0710112139<br>15.09.2017 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from Bangalore. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from Bangalore.
29
| 103 |
Case No.:515/15/82-<br>ALC4/2018 |
Party Name:MEDREICH<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01972/AM19/ |
RLA File<br>:07/24/040/00179/AM18/ |
Lic.No/Date:0710112226<br>04.10.2017 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from Bangalore. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from Bangalore.
| 104 |
Case No.:327/15/82-<br>ALC4/2018 |
Party Name:JODAS EXPOIM<br>PVT.LTD., |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01784/AM19/ |
RLA File<br>:05/23/040/00268/AM18/ |
Lic.No/Date:0510404290<br>13.10.2017 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from CLA New Delhi.. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA New Delhi..
| 105 |
Case No.:328/15/82-<br>ALC4/2018 |
Party Name:JODAS EXPOIM<br>PVT.LTD., |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01785/AM19/ |
RLA File<br>:05/23/040/00266/AM18/ |
Lic.No/Date:0510404285<br>13.10.2017 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from CLA New Delhi. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA New Delhi.
| 106 |
Case No.:329/15/82-<br>ALC4/2018 |
Party Name:JODAS EXPOIM<br>PVT.LTD., |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01786/AM19/ |
RLA File<br>:05/23/040/00267/AM18/ |
Lic.No/Date:0510404287<br>13.10.2017 |
Defer Date |
|
**Decision:**The Committee<br>available. Hence, it was decided<br>from CLA New Delhi. |
noted that the 4.07 application of subject Advance Authorization is not<br>to call for a copy of 4.07 application of the subject advance authorization |
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA New Delhi.
| 107 |
Case No.:550/15/82-<br>ALC4/2018 |
Party Name:TADIMETY<br>AROMATICS PVT. LTD<br>RLA File<br>:07/24/040/00202/AM18/ |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br> <br><br>Lic.No/Date:0710112366<br>08.11.2017<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02007/AM19/ |
|
|
Defer Date |
|
<br>**Decision:**The Committee considered the case as per agenda and it was decided to call for following<br>information from the firm:<br>(i) Complete 4E with all technical details i.e chemistry, molecular weight, stoichiometric<br>reaction and % ofyield on molar basis at everystage. |
|
|
|
30
|
|
Case No.:583/15/82- |
|
Party Name:MEDREICH |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 108 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0710112429 |
|
Defer Date |
|
|
:01/82/050/02040/AM19/ |
|
:07/24/040/00224/AM18/ |
|
20.11.2017 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
Case No.:769/15/82- |
|
Party Name:DORF-KETAL |
|
Meet No/Date:7/82- |
|
Status: |
|
ALC4/2018 |
|
CHEMICALS INDIA |
|
ALC4/2019 |
|
Deferred |
|
|
|
PVT.LTD. |
|
06.09.2019 |
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310817294 |
|
Defer Date |
|
:01/82/050/02226/AM19/ |
|
:03/94/040/00657/AM18/ |
|
24.11.2017 |
|
|
109 Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm:
(i) Complete 4E with all technical details chemistry, molecular weight, stoichiometric reaction and % of yield at every stage.
|
Case No.:723/15/82- |
|
Party Name:AUROBINDO |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
PHARMA LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
|
| 110 |
HQ File |
|
RLA File |
|
Lic.No/Date:0910065719 |
|
Defer Date |
|
|
:01/82/050/02180/AM19/ |
|
:09/24/040/00414/AM18/ |
|
30.11.2017 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Case No.:340/15/82- |
|
Party Name:AETHER |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
|
| 111 |
HQ File |
|
RLA File |
|
Lic.No/Date:5210042456 |
|
Defer Date |
|
|
:01/82/050/01797/AM19/ |
|
:52/24/040/00051/AM18/ |
|
15.12.2017 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
| Case No.:411/15/82- |
|
Party Name:GULBRANDSEN |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
CHEMICALS PVT LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410043725 |
|
|
| :01/82/050/01868/AM19/ |
|
:34/24/040/00262/AM18/ |
|
21.12.2017 |
|
|
Decision: The Committee considered case as per agenda and as per earlier decision taken by NC in its 112 8/82-ALC4/2018 meeting dated 20.09.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
No. |
|
|
|
Ethyl Aluminium Sesqui Chloride |
1 kg |
1 |
Aluminium Grit/Granules |
0.14 kg |
|
(EASC) |
|
|
|
|
| RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
31
| 113 |
<br>Case No.:751/15/82-<br>ALC4/2018 |
Party Name:CADILA<br>HEALTHCARE LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02208/AM19/ |
RLA File<br>:08/24/040/00266/AM18/ |
Lic.No/Date:0810141617<br>27.12.2017 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:66/7/82-ALC4/2019 |
|
Party Name:CIPLA LIMITED. |
|
Meet No/Date:7/82- |
|
Status: |
|
|
|
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310818041 |
|
|
| :01/82/050/00561/AM20/ |
|
:03/94/040/00746/AM18/ |
|
27.12.2017 |
|
|
|
Case No.:66/7/82-ALC4/2019 |
Case No.:66/7/82-ALC4/2019 |
Party Name:CIPLA LIMITED. |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00561/AM20/ |
|
RLA File<br>:03/94/040/00746/AM18/ |
Lic.No/Date:0310818041<br>27.12.2017 |
|
|
| 114 |
<br>**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and<br>in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by<br>NC<br>in<br>its<br>Meeting<br>No.<br>5/82-ALC4/2019<br>, dated 02.08.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>per details below or as applied by firm whichever is lower:<br>Exportproduct<br> Qty.<br>Azelastine Hydrochloride and Fluticasone Nasal Spray / Dymista Nasal<br>Spray (Pack 120MD) pack.<br>1 Number<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Azelastine Hydrochloride<br>16.44 mg<br>2<br>Fluticasone Propionate<br>6.00 mg<br>3<br>140 mcl pumps<br>Net + 1 %<br>4<br>25ml USP type 1 amber glass vial<br>Net + 1 %<br>5<br>Nasalactuator<br>Net+ 1%<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
<br>Exportproduct |
|
|
|
Qty. |
|
|
<br>Azelastine Hydrochloride and Fluticasone Nasal Spray / Dymista Nasal<br>Spray (Pack 120MD) pack. |
|
|
|
1 Number |
|
|
|
|
|
|
|
|
|
Sl. No. |
Import items |
|
|
Qty. |
|
|
1 |
Azelastine Hydrochloride |
|
|
16.44 mg |
|
|
2 |
Fluticasone Propionate |
|
|
6.00 mg |
|
|
3 |
140 mcl pumps |
|
|
Net + 1 % |
|
|
4 |
25ml USP type 1 amber glass vial |
|
|
Net + 1 % |
|
|
5 |
Nasalactuator |
|
|
Net+ 1% |
|
|
RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 5/82-ALC4/2019 , dated 02.08.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
| 115 |
Case No.:348/15/82-<br>ALC4/2018 |
Party Name:ARKRAY<br>HEALTHCARE PVT.LTD. |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01805/AM19/ |
RLA File<br>:52/24/040/00053/AM18/ |
Lic.No/Date:5210042478<br>04.01.2018 |
Defer Date |
|
**Decision:**The Committee<br>available. Hence, it was decided<br>from RLA Surat. |
noted that the 4.07 application of subject Advance Authorization is not<br>to call for a copy of 4.07 application of the subject advance authorization |
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Surat.
| 116 |
Case No.:1021/15/82-<br>ALC4/2018 |
Party Name:ANLON<br>HEALTHCARE<br>PRIVATELIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02478/AM19/ |
RLA File<br>:24/24/040/00039/AM18/ |
Lic.No/Date:2410042334<br>12.01.2018 |
Defer Date |
|
**Decision:**The Committee<br>available. Hence, it was decided<br>from RLA Rajkot. |
noted that the 4.07 application of subject Advance Authorization is not<br>to call for a copy of 4.07 application of the subject advance authorization |
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Rajkot.
32
| Case No.:551/15/82- |
|
Party Name:NATURAL |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
HERBS & FORMULATIONS |
|
ALC4/2019 |
|
Rejected |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:6110001484 |
|
|
| :01/82/050/02008/AM19/ |
|
:61/24/040/00004/AM18/ |
|
16.01.2018 |
|
|
117 Decision: The Committee considered the case as per agenda and it was observed that the firm is importing Vitamin E Acetate Oil 98% (200 kg/drum), which is a vitamin and is using it for manufacturing of Vitamin E, which is a non-pharmaceutical product. As per para 4.11 of FTP (2015-20), import of vitamins is allowed only for use in Pharmaceutical Industry.
In view of above, the Committee decided to reject the case.
|
|
Case No.:819/15/82- |
|
Party Name:DHANUKA |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
LABORATORIES LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 118 |
|
HQ File<br>:01/82/050/02276/AM19/ |
|
RLA File<br>:05/23/040/00440/AM18/ |
|
Lic.No/Date:0510405609<br>09.02.2018 |
|
Defer Date |
|
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not |
|
|
|
|
|
|
|
|
available. Hence, it was decided |
|
to call for a copy of 4.07 application of the subject advance |
|
|
|
authorization |
|
|
from CLA New Delhi. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA New Delhi.
|
|
Case No.:1009/15/82- |
Case No.:1009/15/82- |
|
Party Name:TADIMETY |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
|
AROMATICS PVT. LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
|
06.09.2019 |
|
|
|
|
HQ File |
|
|
RLA File |
|
Lic.No/Date:0710112820 |
|
Defer Date |
| 119 |
|
:01/82/050/02466/AM19/<br>:07/24/040/00305/AM18/<br>**Decision:**The Committee considered the case as per agenda |
|
|
|
13.02.2018<br>and it was decided to call for following |
|
|
|
|
|
information |
from the firm: |
|
|
|
|
|
|
|
|
(ii) |
Complete 4E with all technical details i.echemistry, molecular weight, stoichiometric reaction |
|
|
|
|
|
|
|
|
|
and % ofyield on molar basis at everystage. |
|
|
|
|
|
|
|
|
Case No.:18/15/82-ALC4/2018 |
|
Party Name:AUROBINDO |
|
Meet No/Date:7/82- |
|
Status: |
|
|
|
|
PHARMA LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 120 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910066053 |
|
Defer Date |
|
|
:01/82/050/01475/AM19/ |
|
:09/24/040/00635/AM18/ |
|
12.03.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
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|
|
|
|
33
| Case No.:357/15/82- |
|
Party Name:BIOLOGICAL E |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910066049 |
|
|
| :01/82/050/01814/AM19/ |
|
:09/24/040/00620/AM18/ |
|
12.03.2018 |
|
|
|
Case No.:357/15/82-<br>ALC4/2018 |
Case No.:357/15/82-<br>ALC4/2018 |
Party Name:BIOLOGICAL E<br>LTD |
Party Name:BIOLOGICAL E<br>LTD |
Party Name:BIOLOGICAL E<br>LTD |
Party Name:BIOLOGICAL E<br>LTD |
Party Name:BIOLOGICAL E<br>LTD |
Party Name:BIOLOGICAL E<br>LTD |
Party Name:BIOLOGICAL E<br>LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
Status:<br>Approved |
|
HQ File<br>:01/82/050/01814/AM19/ |
|
RLA File<br>:09/24/040/00620/AM18/ |
|
|
|
|
|
|
Lic.No/Date:0910066049<br>12.03.2018 |
|
|
|
|
|
**Decision:**The Committee considered the case as per agenda and on the basis of written comments<br>furnished by Department of Biotechnology vide Office Memorandum No. BT/IL/05/05382/2013-PID,<br>dated 16.09.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>per details below or as applied by firm whichever is lower: |
|
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|
|
|
|
|
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
|
Import items |
|
|
|
|
Qty.<br>(per Million |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
vials) |
|
|
|
|
DTP-HEPB-HIB<br>(PENTAVALENT VACCIN<br>FULLY LIQUID<br>COMBINATION VACCINI |
E) |
1<br>million |
1 |
|
POLY<br>6000 |
|
ETHYLENE GLYCOL<br>(MACROGOL) |
|
|
76.848 kg |
|
|
|
|
|
E |
vials |
2 |
|
AERO<br>ANH |
|
SIL 380V (COLLIDAL<br>SILICA) |
|
|
20.375 kg |
|
|
|
|
|
|
|
3 |
|
GLY |
|
EROL |
|
|
122841 |
|
|
| 121 |
|
SINGLE DOSE (0.5ML) VIAL,<br>PEDIATRIC DOSE<br>DIPTHERIA, TETANUS,<br>PERTUSSIS, HEPATITIS B |
|
|
|
|
|
|
|
|
|
.<br>litres |
|
|
|
|
|
|
|
4 |
|
POLYSRBATE 20 (TWEEN-<br>20) |
|
|
|
|
7.685 litres |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
169.742<br>grams |
|
|
|
|
<br>RECOMBINANT AND<br>HAEMOPHILUS INFLUENZA |
|
|
5 |
|
|
OTASSIUM THYO |
|
|
YNATE |
169.742<br>grams |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TYPE B (HIB) COMBINED<br>VACCINE WITH VACCINE<br>VIAL MONITOR (VVM)<br>(EACH VIAL=0.5ML/SINGLE<br>DOSE) |
|
|
6 |
|
|
RIS BUFFER |
|
|
|
10.216 kg |
|
|
|
|
|
|
|
7 |
|
A<br> |
LUMINIUM CHLO<br> |
|
|
RIDE 6 |
27.665 kg |
|
|
|
|
|
|
|
|
|
H |
YDRATE EXTRA |
|
|
|
|
|
|
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|
|
|
|
8 |
|
Y |
EAST EXTRACT |
|
|
|
22.447 kg |
|
|
|
|
|
|
|
9 |
|
D |
EXTROSE(GLUCO |
|
|
SE) |
35.937 kg |
|
|
|
|
|
|
|
10 |
|
L |
-CYSTINE |
|
|
|
0.437 kg |
|
|
|
|
|
|
|
11 |
|
C |
AS AMINO ACID |
|
|
|
31758 kg |
|
|
|
|
|
|
|
|
|
<br>( |
<br>TECHNICAL GRAD |
|
|
E) |
. |
|
|
|
|
|
|
|
12 |
|
T |
HIOMERSAL |
|
|
|
0379 kg |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
. |
|
|
|
|
|
|
|
13 |
|
S |
ILICON EMULSION |
|
|
|
16.5 kg |
|
|
|
|
|
|
|
14 |
|
A<br>( |
DIPIC DIHYDRAZI<br>ADH) |
|
|
DE |
1.686 kg |
|
|
|
|
|
|
|
15 |
|
E<br> |
DC (N-3-DIMETHY<br> |
|
|
L |
167.545 |
|
|
|
|
|
|
|
|
|
N<br> |
MINOPROPYL-<br>ETHYLCARBODIM<br>CL) |
|
|
IDE |
grams |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16 |
|
2<br>E<br>( |
-(N-MORPHOLINO)<br>THANE SULFONIC<br>MES) |
|
|
<br>ACID |
1.441 kg |
|
|
|
|
|
|
|
17 |
|
C |
ETAVLON |
|
|
|
1537gram |
|
s |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18 |
|
ALUMINIUM PHOSPHATE<br>GEL 2% (ADJU.PHOS 2%) |
|
|
|
|
|
|
|
|
|
|
|
|
19 |
|
LTYROSINE |
|
|
|
|
07841 k |
|
|
|
|
|
|
|
|
|
- |
|
|
|
|
.g |
|
|
|
|
|
|
|
20 |
|
N Z CASE TT (CASEIN<br>PEPTONE PLUS) |
|
|
|
|
39.12 kg |
|
|
|
|
|
|
|
21 |
|
THIAMINE<br>HYDROCHLORIDE<br>(VITAMIN B1 HCL) |
|
|
|
|
1.14 grams |
|
|
|
|
|
|
|
22 |
|
ETHANOL (ETHYL<br>ALCOHOL) |
|
|
|
|
680.188<br>litres |
|
|
34
| 23 |
GLASS VIALS |
1100000 |
|
|
nos. |
| 24 |
RUBBER STOPPERS |
1095638 |
|
|
nos. |
| 25 |
ALUMINIUM CAPS/SEALS |
1088334 |
|
|
nos. |
| 26 |
HEATMARKER VACCINE |
1086508 |
|
VIAL MONITOR (VVM |
nos. |
|
LABELS) LABELS |
|
| 27 |
SHIPPING INDICATORS (Q |
902 nos. |
|
TAG 2 PLUS/VAX |
|
|
ALERT/TEMPERATURE |
|
|
MONITORING |
|
|
DEVICES/DATA LOGGERS) |
|
| 28 |
FILTER & FILTER AIDS |
250 nos. |
| 122 |
Case No.:358/15/82-<br>ALC4/2018 |
Party Name:BIOLOGICAL E<br>LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/01815/AM19/ |
RLA File<br>:09/24/040/00600/AM18/ |
Lic.No/Date:0910066050<br>12.03.2018 |
Defer Date |
|
<br>**Decision:**The Committee considered the case as per agenda and on the basis of written comments<br>furnished by Department of Biotechnology vide Office Memorandum No. BT/IL/05/05382/2013-PID,<br>dated 16.09.2019, it was decided to call for following information from the firm:<br>(i)<br>Justification of wastage claimed alongwith copy of relevant proportions of batch<br>manufacturingrecord / CA Certificate. |
|
|
|
| 123 |
Case No.:359/15/82-<br>ALC4/2018 |
Party Name:BIOLOGICAL E<br>LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01816/AM19/ |
RLA File<br>:09/24/040/00586/AM18/ |
Lic.No/Date:0910066051<br>12.03.2018 |
Defer Date |
|
**Decision:**A copy of application has been forwarded to DBT on<br>TE. |
|
17.07.2019. Deferred for comments of |
|
35
| Case No.:362/15/82- |
|
Party Name:DR. REDDYS |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
LABORATORIES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910066082 |
|
|
| :01/82/050/01819/AM19/ |
|
:09/24/040/00652/AM18/ |
|
23.03.2018 |
|
|
|
Case No.:362/15/82-<br>ALC4/2018 |
Party Name:DR. REDDYS<br>LABORATORIES LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/01819/AM19/ |
RLA File<br>:09/24/040/00652/AM18/ |
Lic.No/Date:0910066082<br>23.03.2018 |
|
| 124 |
<br>**Decision:**The Committee considered case as per agenda and in the presence of the technical experts, it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as 0per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Finasteride - (Form III)<br>1 kg 1<br>3-Oxo-4-Aza-5-a-androstane-17-<br>b-Carboxylic acid (98%)<br>1.7647 kg<br>2<br>BSTFA<br>[Bis-(Trimethylsilyl)-<br>Trifluoro Acetamide]<br>1.47 kg<br>3<br>DDQ[2,3-Dichloro-5,<br>6-<br>Dicynobenzo Quinine]<br>0.86 kg<br>4<br>Methylene Chloride<br>7.50 kg<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as 0per details below or as applied by firm whichever is lower:
| 125 |
Case No.:67/15/82-ALC4/2018 |
Party Name:BIOLOGICAL E<br>LTD<br>RLA File<br>:09/24/040/00637/AM18/ |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br> <br><br>Lic.No/Date:0910066088<br>26.03.2018<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01524/AM19/ |
|
|
Defer Date |
|
**Decision:**A copy of application has been forwarded to DBT on<br>DBT. |
|
17.07.2019. Deferred for comments of |
|
| 126 |
Case No.:1014/15/82-<br>ALC4/2018 |
Party Name:TADIMETY<br>AROMATICS PVT. LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02471/AM19/ |
RLA File<br>:07/24/040/00361/AM18/ |
Lic.No/Date:0710113089<br>10.04.2018 |
|
|
<br>**Decision:**The Committee considered the case as per agenda and it was decided to call for following<br>information from the firm:<br>(i) Complete 4E with all technical details i.e chemistry, molecular weight, stoichiometric reaction and<br>% ofyield on molar basis at everystage. |
|
|
|
| 127 |
<br>Case No.:26/15/82-ALC4/2018 |
Party Name:GLAND<br>CHEMICALS PVT LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/01483/AM19/ |
RLA File<br>:09/24/040/00008/AM19/ |
Lic.No/Date:0910066148<br>17.04.2018 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
36
| 128 |
<br>Case No.:6/15/82-ALC4/2018 |
Party Name:AUROBINDO<br>PHARMA LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01463/AM19/ |
RLA File<br>:09/24/040/00015/AM19/ |
Lic.No/Date:0910066157<br>18.04.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:81/15/82-ALC4/2018 |
|
Party Name:YASH RASAYAN |
|
Meet No/Date:7/82- |
|
Status: |
|
|
& CHEMICALS |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410044109 |
|
Defer Date |
| :01/82/050/01538/AM19/ |
|
:34/24/040/00401/AM18/ |
|
27.04.2018 |
|
|
Decision: RLA, Vadodara was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07 application of subject Advance Authorization. Application is still awaited from RLA Vadodara. Hence, it was decided to issue a Reminder to RLA, Vadodara for furnishing a copy of 4.07 application of subject 129 Advance Authorization expeditiously. Further, the Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 15/82-ALC4/2018 dated 22.03.2019, followed by Reminder on 01.07.2019 and Final Reminder on 01.08.2019:
(i) Complete technical details as per Appendix 4 E alongwith Molecular Weight, percentage of yield and stoichiometric chemical reaction.
Reply awaited from the firm.
| 130 |
Case No.:366/15/82-<br>ALC4/2018 |
Party Name:WINTAC<br>LIMITED, |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01823/AM19/ |
RLA File<br>:07/24/040/00008/AM19/ |
Lic.No/Date:0710113260<br>10.05.2018 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA Bangalore. |
|
|
|
| Case No.:5/7/82-ALC4/2019 |
|
Party Name:GLOBAL |
|
Meet No/Date:7/82- |
|
Status: |
|
|
CALCIUM PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED, |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710113317 |
|
|
| :01/82/050/00500/AM20/ |
|
:07/24/040/00026/AM19/ |
|
22.05.2018 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as 0per details below or as 131 applied by firm whichever is lower:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| CALCIUM GLUCONATE -<br>POWDER |
120 M.T. |
1 |
CALCIUM GLUCONATE -<br>GRANULAR |
120 M.T. |
RA may take appropriate action as per the decision of Norms Committee.
37
|
Case No.:373/15/82- |
|
Party Name:TADIMETY |
|
Meet No/Date:7/82- |
|
Status: |
|
ALC4/2018 |
|
AROMATICS PVT. LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
06.09.2019 |
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:0710113330 |
|
Defer Date |
|
:01/82/050/01830/AM19/ |
|
:07/24/040/00046/AM19/ |
|
25.05.2018 |
|
|
132 Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm:
(i) Complete 4E with all technical details i.e chemistry, molecular weight, stoichiometric reaction and % of yield on molar basis at every stage.
|
|
Case No.:376/15/82- |
|
Party Name:GRANULES |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
INDIA LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 133 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910066295 |
|
Defer Date |
|
|
:01/82/050/01833/AM19/ |
|
:09/24/040/00099/AM19/ |
|
04.06.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:378/15/82- |
|
Party Name:JODAS EXPOIM |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
PVT.LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 134 |
|
HQ File<br>:01/82/050/01835/AM19/ |
|
RLA File<br>:05/23/040/00080/AM19/ |
|
Lic.No/Date:0510406733<br>05.06.2018 |
|
Defer Date |
|
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not |
|
|
|
|
|
|
|
|
available. Hence, it was decided |
to call for a copy of 4.07 application of the subject advance |
|
|
|
authorization |
|
|
|
from CLA New Delhi. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA New Delhi.
|
|
Case No.:379/15/82- |
|
Party Name:JODAS EXPOIM |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
PVT.LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 135 |
|
HQ File<br>:01/82/050/01836/AM19/ |
|
RLA File<br>:05/23/040/00070/AM19/ |
|
Lic.No/Date:0510406734<br>05.06.2018 |
|
Defer Date |
|
|
**Decision:**The Committee noted that the 4.07 application |
|
|
of subject Advance Authorization is not |
|
|
|
|
|
available. Hence, it was decided |
to call for a copy of 4.07 application of the subject advance |
|
|
|
authorization |
|
|
|
from CLA New Delhi |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA New Delhi
| 136 |
<br>Case No.:380/15/82-<br>ALC4/2018<br>Party Name:JODAS EXPOIM<br>PVT.LTD<br>Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Status:<br>Deferred<br>HQ File<br>:01/82/050/01837/AM19/<br>RLA File<br>:05/23/040/00022/AM19/<br>Lic.No/Date:0510406736<br>05.06.2018<br>Defer Date<br>**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from CLA New Delhi. |
Party Name:JODAS EXPOIM<br>PVT.LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
|
RLA File<br>:05/23/040/00022/AM19/ |
Lic.No/Date:0510406736<br>05.06.2018 |
Defer Date |
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA New Delhi.
38
| 137 |
<br>Case No.:60/15/82-ALC4/2018 |
Party Name:ALPHAMED<br>FORMULATIONS P LTD. |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01517/AM19/ |
RLA File<br>:09/24/040/00075/AM19/ |
Lic.No/Date:0910066310<br>08.06.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 138 |
Case No.:383/15/82-<br>ALC4/2018 |
Party Name:JODAS EXPOIM<br>PVT.LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01840/AM19/ |
RLA File<br>:05/23/040/00121/AM19/ |
Lic.No/Date:0510406800<br>08.06.2018 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from CLA New Delhi. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA New Delhi.
| 139 |
Case No.:385/15/82-<br>ALC4/2018 |
Party Name:JODAS EXPOIM<br>PVT.LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01842/AM19/ |
RLA File<br>:05/23/040/00501/AM18/ |
Lic.No/Date:0510406802<br>08.06.2018 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from CLA New Delhi. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA New Delhi.
|
Case No.:74/15/82-ALC4/2018 |
|
Party Name:VIRCHOW |
|
Meet No/Date:7/82- |
|
Status: |
|
|
|
PETROCHEMICAL PVT |
|
ALC4/2019 |
|
Withdrawn |
|
|
|
LTD. |
|
06.09.2019 |
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910066321 |
|
|
|
:01/82/050/01531/AM19/ |
|
:09/24/040/00624/AM18/ |
|
11.06.2018 |
|
|
140 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was observed that the norms for the subject Advance Authorization have already been ratified by NC-3 in its Meeting No. 2/AM20 dated 21.06.2019 (Case No. B-6).
, the Committee decided to withdraw the case.
| 141 |
Case No.:386/15/82-<br>ALC4/2018 |
Party Name:VIVIMED LIFE<br>SCIENCES PRIVATE<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01843/AM19/ |
RLA File<br>:09/24/040/00107/AM19/ |
Lic.No/Date:0910066339<br>14.06.2018 |
Defer Date |
|
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide e-mail<br>dated 19.07.2019 has furnished its reply. Deferred for comments of TE. |
|
|
|
39
| Case No.:489/15/82- |
|
Party Name:J.B. CHEMICALS |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
& PHARMACEUTICALS |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310821859 |
|
|
| :01/82/050/01946/AM19/ |
|
:03/94/040/00244/AM19/ |
|
21.06.2018 |
|
|
|
Case No.:489/15/82-<br>ALC4/2018 |
Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/01946/AM19/ |
RLA File<br>:03/94/040/00244/AM19/ |
Lic.No/Date:0310821859<br>21.06.2018 |
|
| 142 |
<br>**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and<br>in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by<br>NC<br>in<br>its<br>Meeting<br>No.<br>5/82-ALC4/2019<br>, dated 02.08.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>per details below or as applied by firm whichever is lower:<br>Sl.<br>No.<br>Export Product<br>Qty.<br>1.<br>GLIPIZIDE EXTENDED-RELEASE TABLETS 10 MG. Each tablet contains<br>(i)<br>Glipizide<br>USP-<br>10<br>mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 29.70 mg (iii) Sentry<br>Polyox WSR N80 FP NF- 178.10 mg (iv) Sentry Polyox WSR 303 NF- 100<br>mg. Net content (i) 125 Kgs (ii) 371.25 Kgs (iii) 2226.25 Kgs (iv) 1250 Kgs.<br>1 Number<br>2.<br>GLIPIZIDE EXTENDED-RELEASE TABLETS 5 MG. Each tablet contains<br>(i)<br>Glipizide<br>USP-<br>5<br>mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 20.40 mg (iii) Sentry<br>Polyox WSR N80 FP NF- 89.05 mg (iv) Sentry Polyox WSR 303 NF- 50 mg.<br>Net content (i) 58.333 Kgs (ii) 238.001 Kgs (iii) 1038.92 Kgs (iv) 583.335<br>Kgs.<br>1 Number<br>3.<br>GLIPIZIDE EXTENDED-RELEASE TABLETS 2.5 MG. Each tablet<br>contains<br>(i)<br>Glipizide<br>USP-<br>2.5<br>mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 20.40 mg (iii) Sentry<br>Polyox WSR N80 FP NF- 89.05 mg (iv) Sentry Polyox WSR 303 NF- 50 mg.<br>Net content (i) 25 Kgs (ii) 204.001 Kgs (iii) 890.504 Kgs (iv) 500.003 Kgs.<br>1 Number<br>Sl.<br>No.<br>Import Items<br>For export of 1 Number of Tablet<br>2.5 mg<br>5.0 mg<br>10.0 mg<br>1<br>GLIPIZIDE USP<br>2.55 mg<br>5.10 mg<br>10.20 mg<br>2<br>EASTMAN (TM)<br>CELLULOSE ACETATE<br>(CA 398-10NF/EP)<br>20.40 mg<br>20.40 mg<br>29.70 mg<br>3<br>SENTRY POLYOX WSR<br>N80 FP NF<br>89.05 mg<br>89.05 mg<br>178.10 mg<br>4<br>SENTRY POLYOX WSR<br>303 NF<br>50.00 mg<br>50.00 mg<br>100.00 mg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 5/82-ALC4/2019 , dated 02.08.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
| 143 |
Case No.:388/15/82-<br>ALC4/2018 |
Party Name:WINTAC<br>LIMITED, |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01845/AM19/ |
RLA File<br>:07/24/040/00063/AM19/ |
Lic.No/Date:0710113471<br>22.06.2018 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA Bangalore. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Bangalore.
40
| 144 |
Case No.:51/15/82-ALC4/2018 |
Case No.:51/15/82-ALC4/2018 |
Party Name:AUROBINDO<br>PHARMA LIMITED |
Party Name:AUROBINDO<br>PHARMA LIMITED |
Party Name:AUROBINDO<br>PHARMA LIMITED |
Party Name:AUROBINDO<br>PHARMA LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/01508/AM19/ |
|
RLA File<br>:09/24/040/00126/AM19/ |
|
|
|
Lic.No/Date:0910066386<br>26.06.2018 |
|
|
|
<br>**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and<br>in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by<br>NC<br>in<br>its<br>Meeting<br>No.<br>8/82-ALC4/2018<br>, dated 31.08.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>AMPICILLIN TRIHYDRATE<br>1 kg<br>1<br>6-Amino Penicillanic Acid (6-<br>APA)<br>0.596kg<br>2<br>Penicillin G Amidase (Particle<br>size 250 - 500 micron,<br>Creamish to Brown regularly<br>shaped beads)<br>or (Immobilized Acylase<br>Enzyme) Xinase<br>0.0018kg<br>3<br>Isopropyl alcohol(IPA)<br>0.304kg<br>4<br>D(-) Alpha Phenyl Glycine<br>Base (PG Base)<br>0.417kg<br>5<br>Toluene<br>0.288kg<br>6<br>Methanol(Methyl Alcohol)<br>0.692kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
|
AMPICILLIN TRIHYDRATE |
|
1 kg |
1 |
6-Amino Penicillanic Acid (6-<br>APA) |
|
0.596kg |
|
|
|
|
|
|
2 |
Penicillin G Amidase (Particle<br>size 250 - 500 micron,<br>Creamish to Brown regularly<br>shaped beads)<br>or (Immobilized Acylase<br>Enzyme) Xinase |
|
0.0018kg |
|
|
|
|
|
|
3 |
Isopropyl alcohol(IPA) |
|
0.304kg |
|
|
|
|
|
|
4 |
D(-) Alpha Phenyl Glycine<br>Base (PG Base) |
|
0.417kg |
|
|
|
|
|
|
5 |
Toluene |
|
0.288kg |
|
|
|
|
|
|
6 |
Methanol(Methyl Alcohol) |
|
0.692kg |
|
|
|
|
|
|
|
|
|
|
|
| Case No.:1023/15/82- |
|
Party Name:LASENOR INDIA |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
PRIVATE LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:5010002456 |
|
|
| :01/82/050/02480/AM19/ |
|
:50/24/040/00008/AM19/ |
|
27.06.2018 |
|
|
|
Case No.:1023/15/82-<br>ALC4/2018 |
Case No.:1023/15/82-<br>ALC4/2018 |
Party Name:LASENOR INDIA<br>PRIVATE LIMITED |
Party Name:LASENOR INDIA<br>PRIVATE LIMITED |
Party Name:LASENOR INDIA<br>PRIVATE LIMITED |
Party Name:LASENOR INDIA<br>PRIVATE LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Lic.No/Date:5010002456<br>27.06.2018 |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Lic.No/Date:5010002456<br>27.06.2018 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/02480/AM19/ |
|
RLA File<br>:50/24/040/00008/AM19/ |
|
|
|
|
|
|
| 145 |
<br>**Decision:**The Committee considered case as per agenda and in the presence of the technical experts, it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as 0per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Sunflower Lecithin(Powder)<br>1 kg<br>1<br>Sunflower Lecithin<br>1 kg<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
|
Sunflower Lecithin(Powder) |
|
1 kg |
1 |
Sunflower Lecithin |
|
1 kg |
|
|
|
|
|
per the decision of |
|
Norms Committee. |
|
|
|
| 146 |
<br>Case No.:12/15/82-ALC4/2018 |
Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/01469/AM19/ |
RLA File<br>:09/24/040/00113/AM19/ |
Lic.No/Date:0910066403<br>28.06.2018 |
|
|
**Decision:**Deferred for Comments of TE. |
|
|
|
41
| Case No.:1024/15/82- |
|
Party Name:ANLON |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
HEALTHCARE |
|
ALC4/2019 |
|
Approved |
|
|
PRIVATELIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:2410042448 |
|
|
| :01/82/050/02481/AM19/ |
|
:24/24/040/00012/AM19/ |
|
02.07.2018 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 14/82-ALC4/2014 dated 14.02.2019, it was decided to ratify norms under Para 4.7 of HBP v1 147 as per details given below or as applied by the firm, whichever is less:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| 2-(4-((2- |
1 kg |
1 |
Methyl 2-oxocyclopentane carboxylate |
0.727 kg |
| oxocyclopentyl)methyl)phenyl)propanoic |
|
|
- 10472-24-9 |
|
| acid.- |
|
|
|
|
| case No.68767-14-6 |
|
|
|
|
RA may take appropriate action as per the decision of Norms Committee.
| 148 |
Case No.:417/15/82-<br>ALC4/2018 |
Party Name:JODAS EXPOIM<br>PVT.LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01874/AM19/ |
RLA File<br>:05/23/040/00167/AM19/ |
Lic.No/Date:0510407069<br>04.07.2018 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from CLA New Delhi. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA New Delhi.
| 149 |
Case No.:418/15/82-<br>ALC4/2018 |
Party Name:JODAS EXPOIM<br>PVT.LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01875/AM19/ |
RLA File<br>:05/23/040/00163/AM19/ |
Lic.No/Date:0510407077<br>04.07.2018 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from CLA New Delhi. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA New Delhi.
| 150 |
Case No.:419/15/82-<br>ALC4/2018 |
Party Name:JODAS EXPOIM<br>PVT.LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01876/AM19/ |
RLA File<br>:05/23/040/00164/AM19/ |
Lic.No/Date:0510407078<br>04.07.2018 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from CLA New Delhi. |
|
|
|
42
Case No.:57/15/82-ALC4/2018 Party Name:AUROBINDO Meet No/Date:7/82- Status: PHARMA LIMITED ALC4/2019 Approved 06.09.2019 HQ File RLA File Lic.No/Date:0910066417 :01/82/050/01514/AM19/ :09/24/040/00161/AM19/ 04.07.2018 Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No.8/82-ALC4/2018 , dated 31.08.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
|
|
Decision: |
Decision: |
Decision: |
The Committee considered the case |
The Committee considered the case |
The Committee considered the case |
The Committee considered the case |
The Committee considered the case |
The Committee considered the case |
The Committee considered the case |
as per agenda in the presence of |
Technical Experts and |
Technical Experts and |
|
|
|
in |
|
<br>the |
light |
of |
earlier |
decision |
|
taken |
|
by<br>NC<br>in<br>its<br>Meeting |
No.8/82-ALC4/2018 |
|
|
|
|
, dated 31.08.2018, it |
|
|
|
|
was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as |
|
|
|
|
|
|
|
|
|
|
per details |
|
|
below or as applied by firm |
|
|
|
whichever is lower: |
|
|
|
|
|
|
|
|
|
|
Export |
product |
|
|
|
Qty. |
|
Sl. |
<br>Import items |
|
Qty. |
|
|
|
|
|
|
|
|
|
|
|
|
No. |
|
|
|
|
| 151 |
|
|
|
AMPICILLIN TRIHYDRATE |
|
|
|
|
1 kg |
|
1 |
6-Amino Penicillanic Acid (6- |
|
0.596kg |
|
|
|
|
|
|
|
|
|
|
|
|
|
APA) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2 |
D-Phenyl Glycine Methyl Ester |
|
0.417kg |
|
|
|
|
|
|
|
|
|
|
|
|
|
Hydrochloride |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3 |
Penicillin G Amidase (Particle |
|
0.0018kg |
|
|
|
|
|
|
|
|
|
|
|
|
|
size 250 - 500 micron, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Creamish to Brown regularly |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
shaped beads) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
or (Immobilized Acylase |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Enzyme) Xinase |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4 |
Isopropyl Alcohol |
|
0.304kg |
|
|
|
RA concerned maytake further |
|
|
|
|
|
necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
|
|
Case No.:58/15/82-ALC4/2018 |
|
Party Name:AUROBINDO |
|
Meet No/Date:7/82- |
|
Status: |
|
|
|
|
PHARMA LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 152 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910066418 |
|
Defer Date |
|
|
:01/82/050/01515/AM19/ |
|
:09/24/040/00168/AM19/ |
|
04.07.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:389/15/82- |
|
Party Name:ATUL LIMITED, |
|
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
|
|
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
|
06.09.2019 |
|
|
| 153 |
|
HQ File<br>:01/82/050/01846/AM19/ |
|
RLA File<br>:08/24/040/00030/AM19/ |
|
|
Lic.No/Date:0810142955<br>04.07.2018 |
|
Defer Date |
|
|
**Decision:**The Committee noted that the 4.07 application |
|
|
of subject Advance Authorization is not |
|
|
|
|
|
|
available. Hence, it was decided |
to call for a copy of 4.07 application of the subject advance |
|
|
|
|
authorization |
|
|
|
from RLA Ahmedabad. |
|
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Ahmedabad.
|
|
Case No.:617/15/82- |
|
Party Name:JODAS EXPOIM |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
PVT.LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 154 |
|
HQ File<br>:01/82/050/02074/AM19/ |
|
RLA File<br>:05/23/040/00166/AM19/ |
|
Lic.No/Date:0510407070<br>04.07.2018 |
|
Defer Date |
|
|
**Decision:**The Committee |
|
noted that the 4.07 application |
of subject Advance Authorization is not |
|
|
|
|
|
available. Hence, it was decided |
to call for a copy of 4.07 application of the subject advance |
|
|
|
authorization |
|
|
|
from CLA New Delhi. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA New Delhi.
43
| Case No.:427/15/82- |
|
Party Name:BIOLOGICAL E |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910066426 |
|
|
| :01/82/050/01884/AM19/ |
|
:09/24/040/00145/AM19/ |
|
06.07.2018 |
|
|
|
Case No.:427/15/82-<br>ALC4/2018 |
Case No.:427/15/82-<br>ALC4/2018 |
Party Name:BIOLOGICAL E<br>LTD |
Party Name:BIOLOGICAL E<br>LTD |
Party Name:BIOLOGICAL E<br>LTD |
Party Name:BIOLOGICAL E<br>LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/01884/AM19/ |
|
RLA File<br>:09/24/040/00145/AM19/ |
|
|
|
Lic.No/Date:0910066426<br>06.07.2018 |
|
|
| 155 |
<br>**Decision:**The Committee considered the case as per agenda and on the basis of written comments<br>furnished by Department of Biotechnology vide Office Memorandum No. BT/IL/05/05382/2013-PID,<br>dated 16.09.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty. per<br>100000<br>doses<br>ADSORBED<br>TETANUS<br>VACCINE<br>BP/TETANUS<br>TOXOID<br>VACCINE<br>ADSORBED-10ML 20 DOSE<br>(EACH DOSE EQUIVALENT<br>TO 0.5ML & EACH VIAL 20<br>DOSE)<br>100000<br>doses<br>1<br>L-CYSTINE<br>As per SION<br>A-2304<br>2<br>THIOMERSAL<br>As per SION<br>A-2304<br>3<br>N Z CASE TT (CASEIN<br>PEPTONE PLUS)<br>As per SION<br>A-2304<br>4<br>L-TYROSINE<br>As per SION<br>A-2304<br>5<br>ALUMINIUM CHLORIDE 6<br>HYDRATE EXTRA<br>As per SION<br>A-2304<br>6<br>TRI SODIUM ORTHO<br>PHOSPHATE<br>As per SION<br>A-2304<br>7<br>SILICON EMULSION<br>0.043 kg<br>8<br>GLASS VIALS<br>As per SION<br>A-2304<br>9<br>RUBBER STOPPERS<br>As per SION<br>A-2304<br>10<br>ALUMINIUM CAPS/SEALS<br>As per SION<br>A-2304<br>11<br>SHIPPING INDICATORS (Q-<br>TAGS/VAX<br>ALERT/TEMPERATURE<br>MONITORING<br>DEVICES/COLD CHAIN<br>MONITOR CARD)<br>As per SION<br>A-2304<br>12<br>V V M LABELS<br>(HEATMARKER VACCINE<br>VIAL MONITOR LABELS)<br>5005 Nos.<br>13<br>FILTERS & FILTER AIDS<br>2.5 Nos.<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. per<br>100000<br>doses |
|
|
|
ADSORBED<br>TETANUS<br>VACCINE<br>BP/TETANUS<br>TOXOID<br>VACCINE<br>ADSORBED-10ML 20 DOSE<br>(EACH DOSE EQUIVALENT<br>TO 0.5ML & EACH VIAL 20<br>DOSE) |
|
100000<br>doses |
1 |
L-CYSTINE |
|
As per SION<br>A-2304 |
|
|
|
|
|
|
2 |
THIOMERSAL |
|
As per SION<br>A-2304 |
|
|
|
|
|
|
3 |
N Z CASE TT (CASEIN<br>PEPTONE PLUS) |
|
As per SION<br>A-2304 |
|
|
|
|
|
|
4 |
L-TYROSINE |
|
As per SION<br>A-2304 |
|
|
|
|
|
|
5 |
ALUMINIUM CHLORIDE 6<br>HYDRATE EXTRA |
|
As per SION<br>A-2304 |
|
|
|
|
|
|
6 |
TRI SODIUM ORTHO<br>PHOSPHATE |
|
As per SION<br>A-2304 |
|
|
|
|
|
|
7 |
SILICON EMULSION |
|
0.043 kg |
|
|
|
|
|
|
8 |
GLASS VIALS |
|
As per SION<br>A-2304 |
|
|
|
|
|
|
9 |
RUBBER STOPPERS |
|
As per SION<br>A-2304 |
|
|
|
|
|
|
10 |
ALUMINIUM CAPS/SEALS |
|
As per SION<br>A-2304 |
|
|
|
|
|
|
11 |
SHIPPING INDICATORS (Q-<br>TAGS/VAX<br>ALERT/TEMPERATURE<br>MONITORING<br>DEVICES/COLD CHAIN<br>MONITOR CARD) |
|
As per SION<br>A-2304 |
|
|
|
|
|
|
12 |
V V M LABELS<br>(HEATMARKER VACCINE<br>VIAL MONITOR LABELS) |
|
5005 Nos. |
|
|
|
|
|
|
13 |
FILTERS & FILTER AIDS |
|
2.5 Nos. |
|
|
|
|
|
|
|
|
|
|
|
44
|
|
Case No.:43/15/82-ALC4/2018 |
|
Party Name:AKTINOS |
|
Meet No/Date:7/82- |
|
Status: |
|
|
|
|
PHARMA PVT LTD, |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 156 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910066433 |
|
Defer Date |
|
|
:01/82/050/01500/AM19/ |
|
:09/24/040/00174/AM19/ |
|
11.07.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
|
Case No.:45/15/82-ALC4/2018 |
|
Party Name:AUROBINDO |
|
Meet No/Date:7/82- |
|
Status: |
|
|
|
|
|
|
PHARMA LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
|
|
06.09.2019 |
|
|
|
|
157 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910066444 |
|
Defer Date |
|
|
|
|
:01/82/050/01502/AM19/ |
|
:09/24/040/00185/AM19/ |
|
11.07.2018 |
|
|
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Case No.:46/15/82-ALC4/2018 |
|
Party Name:AUROBINDO |
|
Meet No/Date:7/82- |
|
Status: |
|
|
|
|
|
|
PHARMA LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
|
|
06.09.2019 |
|
|
|
|
158 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910066442 |
|
Defer Date |
|
|
|
|
:01/82/050/01503/AM19/ |
|
:09/24/040/00181/AM19/ |
|
11.07.2018 |
|
|
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Case No.:47/15/82-ALC4/2018 |
Case No.:47/15/82-ALC4/2018 |
Case No.:47/15/82-ALC4/2018 |
|
Party Name:AUROBINDO<br>Meet No/Date:7/82- |
Party Name:AUROBINDO<br>Meet No/Date:7/82- |
Party Name:AUROBINDO<br>Meet No/Date:7/82- |
|
|
Status: |
|
|
|
|
|
|
PHARMA LIMITED<br>ALC4/2019 |
|
|
|
|
Approved |
|
|
|
|
|
|
|
|
06.09.2019 |
|
|
|
|
|
HQ File |
|
|
|
RLA File |
|
Lic.No/Date:0910066443 |
|
|
|
|
|
:01/82/050/01504/AM19/ |
|
|
|
:09/24/040/00182/AM19/<br>11.07.2018 |
|
|
|
|
|
|
|
**Decision:**The Committee considered the cases |
|
|
|
|
|
as per agenda and in the light of earlier decision taken in |
|
|
|
|
|
meeting no. 10/82-ALC4/2014 dated 16.10.2018, it was decided to ratify norms under Para |
|
|
|
|
|
|
4.7 of HBP v1 |
|
|
|
|
as per details given below or as applied by the firm, whichever is less: |
|
|
|
|
|
|
|
|
|
|
|
|
Export product |
|
|
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
|
|
|
|
|
No. |
|
|
|
|
|
|
|
CEFUROXIME |
AXETIL |
|
1 kg |
1 |
7-Aminocephalosporanic acid (7- |
0.769 kg |
|
|
|
|
|
CRYSTALLINE |
|
|
|
|
ACA) |
|
|
|
|
|
|
|
|
|
|
2 |
(Z)-2-Methoxy Imino(Furyl-2-YL) |
0.615 kg |
|
|
|
|
|
|
|
|
|
|
Acetic Acid Ammonium Salt (SMIA) |
|
|
|
|
|
|
|
|
|
|
3 |
Chlorosulfonyl Isocyanate |
0.475 kg |
|
|
|
|
|
|
|
|
|
4 |
Acetone |
1.37 kg |
|
|
|
|
|
|
|
|
|
5 |
Activated Carbon (Carbon |
0.034 kg |
|
|
|
|
|
|
|
|
|
|
Enoanticromos) |
|
|
|
|
|
|
|
|
|
|
6 |
Cyclohexane |
1.15 kg |
|
|
|
|
|
|
|
|
|
7 |
Methylenechloride(MDC) |
2.63 kg |
|
|
|
|
|
|
|
|
|
8 |
Methanol(Methyl Alcohol) |
3.75 kg |
|
|
|
|
|
|
|
|
|
9 |
N,N-Dimethyl Acetamide |
4.53 kg |
|
|
|
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
|
|
|
|
|
Case No.:47/15/82-ALC4/2018 |
Case No.:47/15/82-ALC4/2018 |
Case No.:47/15/82-ALC4/2018 |
|
Party Name:AUROBINDO<br>Meet No/Date:7/82- |
Party Name:AUROBINDO<br>Meet No/Date:7/82- |
Party Name:AUROBINDO<br>Meet No/Date:7/82- |
|
|
Status: |
|
|
|
|
|
|
PHARMA LIMITED<br>ALC4/2019 |
|
|
|
|
Approved |
|
|
|
|
|
|
|
|
06.09.2019 |
|
|
|
|
|
HQ File |
|
|
|
RLA File |
|
Lic.No/Date:0910066443 |
|
|
|
|
|
:01/82/050/01504/AM19/ |
|
|
|
:09/24/040/00182/AM19/<br>11.07.2018 |
|
|
|
|
|
|
|
**Decision:**The Committee considered the cases |
|
|
|
|
|
as per agenda and in the light of earlier decision taken in |
|
|
|
|
|
meeting no. 10/82-ALC4/2014 dated 16.10.2018, it was decided to ratify norms under Para |
|
|
|
|
|
|
4.7 of HBP v1 |
|
|
|
|
as per details given below or as applied by the firm, whichever is less: |
|
|
|
|
|
|
|
|
|
|
|
|
Export product |
|
|
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
|
|
|
|
|
No. |
|
|
|
|
|
|
|
CEFUROXIME |
AXETIL |
|
1 kg |
1 |
7-Aminocephalosporanic acid (7- |
0.769 kg |
|
|
|
|
|
CRYSTALLINE |
|
|
|
|
ACA) |
|
|
|
|
|
|
|
|
|
|
2 |
(Z)-2-Methoxy Imino(Furyl-2-YL) |
0.615 kg |
|
|
|
|
|
|
|
|
|
|
Acetic Acid Ammonium Salt (SMIA) |
|
|
|
|
|
|
|
|
|
|
3 |
Chlorosulfonyl Isocyanate |
0.475 kg |
|
|
|
|
|
|
|
|
|
4 |
Acetone |
1.37 kg |
|
|
|
|
|
|
|
|
|
5 |
Activated Carbon (Carbon |
0.034 kg |
|
|
|
|
|
|
|
|
|
|
Enoanticromos) |
|
|
|
|
|
|
|
|
|
|
6 |
Cyclohexane |
1.15 kg |
|
|
|
|
|
|
|
|
|
7 |
Methylenechloride(MDC) |
2.63 kg |
|
|
|
|
|
|
|
|
|
8 |
Methanol(Methyl Alcohol) |
3.75 kg |
|
|
|
|
|
|
|
|
|
9 |
N,N-Dimethyl Acetamide |
4.53 kg |
|
|
|
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
|
|
|
|
45
|
|
Case No.:432/15/82- |
|
Party Name:JODAS EXPOIM |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
PVT.LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 160 |
|
HQ File<br>:01/82/050/01889/AM19/ |
|
RLA File<br>:05/23/040/00183/AM19/ |
|
Lic.No/Date:0510407217<br>17.07.2018 |
|
Defer Date |
|
|
**Decision:**The Committee |
|
noted that the 4.07 application of subject Advance Authorization is not |
|
|
|
|
|
|
available. Hence, it was decided |
to call for a copy of 4.07 application of the subject advance authorization |
|
|
|
|
|
|
|
from CLA New Delhi. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA New Delhi.
|
|
Case No.:444/15/82- |
|
Party Name:OPTIMUS |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
DRUGS PRIVATE LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 161 |
|
HQ File<br>:01/82/050/01901/AM19/ |
|
RLA File<br>:09/24/040/00193/AM19/ |
|
Lic.No/Date:0910066488<br>19.07.2018 |
|
Defer Date |
|
|
**Decision:**The Committee |
|
noted that the 4.07 application |
of subject Advance Authorization is not |
|
|
|
|
|
available. Hence, it was decided |
to call for a copy of 4.07 application of the subject advance authorization |
|
|
|
|
|
|
|
from RLA Hyderabad. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Hyderabad.
|
|
Case No.:446/15/82- |
|
Party Name:GRANULES |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
INDIA LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 162 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910066498 |
|
Defer Date |
|
|
:01/82/050/01903/AM19/ |
|
:09/24/040/00194/AM19/ |
|
24.07.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:448/15/82- |
|
Party Name:AUROBINDO |
|
Meet No/Date:7/82- |
|
|
Status:Deferred |
|
|
ALC4/2018 |
|
PHARMA LIMITED |
|
ALC4/2019 |
|
|
|
|
|
|
|
|
|
06.09.2019 |
|
|
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910066511 |
|
|
Defer Date |
| 163 |
|
:01/82/050/01905/AM19/ |
|
:09/24/040/00200/AM19/ |
|
24.07.2018 |
|
|
|
|
|
**Decision:**The Committee |
considered the case as per agenda and it was decided to |
|
|
|
call for following |
|
|
|
|
information from the firm: |
|
|
|
|
|
|
|
|
|
(i) Ratio of ‘Cefuroxime’ |
|
and ‘Povidone’ alongwith relevant DrugManufacturer’s Licence(DML). |
|
|
|
|
|
|
|
Case No.:454/15/82- |
|
Party Name:AUROBINDO |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
PHARMA LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 164 |
|
HQ File<br>:01/82/050/01911/AM19/ |
|
RLA File<br>:09/24/040/00209/AM19/ |
|
Lic.No/Date:0910066526<br>31.07.2018 |
|
Defer Date |
|
|
**Decision:**The Committee |
|
noted that the 4.07 application |
of subject Advance Authorization is not |
|
|
|
|
|
available. Hence, it was decided |
to call for a copy of 4.07 application of the subject advance |
|
|
|
authorization |
|
|
|
from RLA Hyderabad. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Hyderabad.
46
|
|
Case No.:642/15/82- |
|
Party Name:DANOPHARM |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
CHEMICALS PRIVATE LTD. |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 165 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310822727 |
|
Defer Date |
|
|
:01/82/050/02099/AM19/ |
|
:03/94/040/00300/AM19/ |
|
31.07.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:460/15/82- |
|
Party Name:WINTAC |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
LIMITED, |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 166 |
|
HQ File<br>:01/82/050/01917/AM19/ |
|
RLA File<br>:07/24/040/00087/AM19/ |
|
Lic.No/Date:0710113686<br>06.08.2018 |
|
Defer Date |
|
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not |
|
|
|
|
|
|
|
|
available. Hence, it was decided |
to call for a copy of 4.07 application of the subject advance authorization |
|
|
|
|
|
|
|
from RLA Bangalore. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Bangalore.
|
|
Case No.:462/15/82- |
|
Party Name:SMILAX |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
LABORATORIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 167 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910066557 |
|
Defer Date |
|
|
:01/82/050/01919/AM19/ |
|
:09/24/040/00223/AM19/ |
|
10.08.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
Case No.:464/15/82- |
|
Party Name:MYLAN |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
LABORATORIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
|
| 168 |
HQ File |
|
RLA File |
|
Lic.No/Date:0910066565 |
|
Defer Date |
|
|
:01/82/050/01921/AM19/ |
|
:09/24/040/00175/AM19/ |
|
13.08.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Case No.:537/15/82- |
|
Party Name:MEDWISE |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
OVERSEAS PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
06.09.2019 |
|
|
|
| 169 |
HQ File |
|
RLA File |
|
Lic.No/Date:0810143251 |
|
Defer Date |
|
|
:01/82/050/01994/AM19/ |
|
:08/24/040/00141/AM19/ |
|
13.08.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
47
|
|
Case No.:470/15/82- |
|
Party Name:JODAS EXPOIM |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
PVT.LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 170 |
|
HQ File<br>:01/82/050/01927/AM19/ |
|
RLA File<br>:05/23/040/00232/AM19/ |
|
Lic.No/Date:0510407550<br>20.08.2018 |
|
Defer Date |
|
|
**Decision:**The Committee noted that the 4.07 application of |
|
|
|
subject Advance Authorization is not |
|
|
|
|
available. Hence, it was decided |
to call for a copy of 4.07 application of the subject advance authorization |
|
|
|
|
|
|
|
from CLA New Delhi. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA New Delhi.
|
|
Case No.:471/15/82- |
|
Party Name:JODAS EXPOIM |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
PVT.LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 171 |
|
HQ File<br>:01/82/050/01928/AM19/ |
|
RLA File<br>:05/23/040/00231/AM19/ |
|
Lic.No/Date:0510407551<br>20.08.2018 |
|
Defer Date |
|
|
**Decision:**The Committee noted that the 4.07 application of |
|
|
|
subject Advance Authorization is not |
|
|
|
|
available. Hence, it was decided |
to call for a copy of 4.07 application of the subject advance authorization |
|
|
|
|
|
|
|
from CLA New Delhi. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA New Delhi.
|
|
Case No.:472/15/82- |
|
Party Name:WINTAC |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
LIMITED, |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 172 |
|
HQ File<br>:01/82/050/01929/AM19/ |
|
RLA File<br>:07/24/040/00131/AM19/ |
|
Lic.No/Date:0710113733<br>20.08.2018 |
|
Defer Date |
|
|
**Decision:**The Committee noted that the 4.07 application of |
|
|
|
subject Advance Authorization is not |
|
|
|
|
available. Hence, it was decided |
to call for a copy of 4.07 application of the subject advance |
|
|
|
authorization |
|
|
|
from RLA Hyderabad. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Hyderabad.
|
|
Case No.:474/15/82- |
|
Party Name:MEDREICH |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 173 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0710113746 |
|
Defer Date |
|
|
:01/82/050/01931/AM19/ |
|
:07/24/040/00129/AM19/ |
|
23.08.2018 |
|
|
|
|
**Decision:**Deferred for Comments of TE. |
|
|
|
|
|
|
|
|
Case No.:475/15/82- |
|
Party Name:WINTAC |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
LIMITED, |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 174 |
|
HQ File<br>:01/82/050/01932/AM19/ |
|
RLA File<br>:07/24/040/00098/AM19/ |
|
Lic.No/Date:0710113754<br>24.08.2018 |
|
Defer Date |
|
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not |
|
|
|
|
|
|
|
|
available. Hence, it was decided |
to call for a copy of 4.07 application of the subject advance |
|
|
|
authorization |
|
|
|
from RLA Hyderabad. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Hyderabad.
48
| 175 |
<br>Case No.:35/15/82-ALC4/2018 |
Party Name:AUROBINDO<br>PHARMA LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01492/AM19/ |
RLA File<br>:09/24/040/00249/AM19/ |
Lic.No/Date:0910066604<br>29.08.2018 |
Defer Date |
|
**Decision:**Deferred for Comments of TE. |
|
|
|
| 176 |
<br>Case No.:492/15/82-<br>ALC4/2018 |
Party Name:ORTIN<br>LABORATORIES LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01949/AM19/ |
RLA File<br>:09/24/040/00245/AM19/ |
Lic.No/Date:0910066600<br>29.08.2018 |
Defer Date |
|
**Decision:**Deferred for Comments of TE. |
|
|
|
|
|
|
|
|
| 177 |
<br>Case No.:502/15/82-<br>ALC4/2018 |
Party Name:SUVEN LIFE<br>SCIENCES LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01959/AM19/ |
RLA File<br>:09/24/040/00260/AM19/ |
Lic.No/Date:0910066621<br>03.09.2018 |
Defer Date |
|
**Decision:**Deferred for Comments of TE. |
|
|
|
| 178 |
<br>Case No.:44/15/82-ALC4/2018 |
Party Name:DISCOVERY<br>LABORATORIES PRIVATE<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01501/AM19/ |
RLA File<br>:09/24/040/00283/AM19/ |
Lic.No/Date:0910066631<br>06.09.2018 |
Defer Date |
|
**Decision:**Deferred for Comments of TE. |
|
|
|
|
|
|
|
|
| 179 |
<br>Case No.:40/15/82-ALC4/2018 |
Party Name:INCHEM<br>LABORATORIES PRIVATE<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01497/AM19/ |
RLA File<br>:09/24/040/00230/AM19/ |
Lic.No/Date:0910066657<br>11.09.2018 |
Defer Date |
|
**Decision:**Deferred for Comments of TE. |
|
|
|
49
| 180 |
<br>Case No.:41/15/82-ALC4/2018 |
Party Name:INCHEM<br>LABORATORIES PRIVATE<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01498/AM19/ |
RLA File<br>:09/24/040/00261/AM19/ |
Lic.No/Date:0910066658<br>11.09.2018 |
Defer Date |
|
**Decision:**Deferred for Comments of TE. |
|
|
|
| 181 |
Case No.:17/7/82-ALC4/2019 |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00512/AM20/ |
RLA File<br>:07/24/040/00144/AM19/ |
Lic.No/Date:0710113843<br>12.09.2018 |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Bangalore. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Bangalore.
| 182 |
<br>Case No.:519/15/82-<br>ALC4/2018 |
Party Name:SUVEN LIFE<br>SCIENCES LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01976/AM19/ |
RLA File<br>:09/24/040/00288/AM19/ |
Lic.No/Date:0910066679<br>18.09.2018 |
Defer Date |
|
**Decision:**Deferred for Comments of TE. |
|
|
|
| 183 |
Case No.:525/15/82-<br>ALC4/2018 |
Party Name:SHILPA<br>MEDICARE LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01982/AM19/ |
RLA File<br>:07/24/040/00164/AM19/ |
Lic.No/Date:0710113890<br>25.09.2018 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Bangalore. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Bangalore.
50
Case No.:18/7/82-ALC4/2019 Party Name:GLOBAL Meet No/Date:7/82- Status: CALCIUM PRIVATE ALC4/2019 Approved LIMITED 06.09.2019 HQ File RLA File Lic.No/Date:0710113896 :01/82/050/00513/AM20/ :07/24/040/00143/AM19/ 25.09.2018 Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 11/82-ALC4/2018 , dated 15.11.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
|
Case No.:18/7/82-ALC4/2019 |
Case No.:18/7/82-ALC4/2019 |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00513/AM20/ |
|
RLA File<br>:07/24/040/00143/AM19/ |
|
|
|
Lic.No/Date:0710113896<br>25.09.2018 |
|
|
| 184 |
<br>**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and<br>in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by<br>NC<br>in<br>its<br>Meeting<br>No.<br>11/82-ALC4/2018<br>, dated 15.11.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>per details below or as applied by firm whichever is lower:<br>Exportproduct<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>CALCIUM LACTOBIONATE<br>1 kg<br>1.<br>CALCIUM CARBONATE<br>0.172 kg<br>2.<br>LACTOSE<br>1.16 kg<br>CALCIUM BROMO<br>LACTOBIONATE<br>1 kg<br>1.<br>CALCIUM CARBONATE<br>0.360 kg<br>2.<br>LACTOSE<br>1.021 kg<br>3.<br>HYDROBROMIC ACID<br>0.510 kg<br>CALCIUM GLUBIONATE<br>1 kg<br>1.<br>CALCIUM CARBONATE<br>0.259kg<br>2.<br>LACTOSE<br>0.829 kg<br>3.<br>CALCIUM GLUCONATE -<br>ORAL GRADE<br>0.430 kg<br>LACTOBIONIC ACID<br>1 kg<br>1.<br>CALCIUM CARBONATE<br>0.234 kg<br>2.<br>LACTOSE<br>1.58 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
|
|
|
Exportproduct |
|
Qty. |
Sl. No. |
Import items |
|
Qty. |
|
|
|
CALCIUM LACTOBIONATE |
|
1 kg |
1. |
CALCIUM CARBONATE |
|
0.172 kg |
|
|
|
|
|
|
2. |
LACTOSE |
|
1.16 kg |
|
|
|
CALCIUM BROMO<br>LACTOBIONATE |
|
1 kg |
1. |
CALCIUM CARBONATE |
|
0.360 kg |
|
|
|
|
|
|
2. |
LACTOSE |
|
1.021 kg |
|
|
|
|
|
|
3. |
HYDROBROMIC ACID |
|
0.510 kg |
|
|
|
CALCIUM GLUBIONATE |
|
1 kg |
1. |
CALCIUM CARBONATE |
|
0.259kg |
|
|
|
|
|
|
2. |
LACTOSE |
|
0.829 kg |
|
|
|
|
|
|
3. |
CALCIUM GLUCONATE -<br>ORAL GRADE |
|
0.430 kg |
|
|
|
LACTOBIONIC ACID |
|
1 kg |
1. |
CALCIUM CARBONATE |
|
0.234 kg |
|
|
|
|
|
|
2. |
LACTOSE |
|
1.58 kg |
|
|
|
|
|
|
|
|
|
|
|
51
| Case No.:19/7/82-ALC4/2019 |
|
Party Name:GLOBAL |
|
Meet No/Date:7/82- |
|
Status: |
|
|
CALCIUM PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710113895 |
|
|
| :01/82/050/00514/AM20/ |
|
:07/24/040/00142/AM19/ |
|
25.09.2018 |
|
|
|
Case No.:19/7/82-ALC4/2019 |
Case No.:19/7/82-ALC4/2019 |
Case No.:19/7/82-ALC4/2019 |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00514/AM20/ |
|
|
RLA File<br>:07/24/040/00142/AM19/ |
|
|
|
Lic.No/Date:0710113895<br>25.09.2018 |
|
| 185 |
<br>**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and<br>in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by<br>NC<br>in<br>its<br>Meeting<br>No.<br>10/82-ALC4/2018<br>, dated 13.11.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>per details below or as applied by firm whichever is lower:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>CALCIUM LACTATE<br>GLUCONATE<br>1 kg<br>1.<br>CALCIUM GLUCONATE -<br>ORAL GRADE<br>0.686 kg<br>2.<br>CALCIUM CARBONATE<br>0.310 kg<br>3<br>LACTIC ACID - ANY<br>GRADE<br>0.560 kg<br>2<br>FERROUS LACTATE<br>1 kg<br>1.<br>LACTIC ACID - ANY<br>GRADE<br>1.028 kg<br>3<br>MAGNESIUM LACTATE<br>1 kg<br>1.<br>LACTIC ACID - ANY<br>GRADE<br>1.19 kg<br>4<br>ZINC LACTATE<br>1 kg<br>1.<br>LACTIC ACID - ANY<br>GRADE<br>0.990 kg<br>5<br>MAGNESIUM LACTATE<br>GLUCONATE<br>1 kg<br>1<br>LACTIC ACID -<br>ANY GRADE<br>0.390 kg<br>2<br>GLUCONO DELTA<br>LACTONE<br>0.617 kg<br>6<br>CALCIUM LACTATE<br>1 kg<br>1<br>LACTIC ACID –<br>ANY GRADE<br>0.922 kg<br>2<br>CALCIUM CARBONATE<br>0.50 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
|
|
|
Sl.<br>No. |
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
1 |
CALCIUM LACTATE<br>GLUCONATE |
|
1 kg |
1. |
CALCIUM GLUCONATE -<br>ORAL GRADE |
|
0.686 kg |
|
|
|
|
|
|
2. |
CALCIUM CARBONATE |
|
0.310 kg |
|
|
|
|
|
|
3 |
LACTIC ACID - ANY<br>GRADE |
|
0.560 kg |
|
|
2 |
FERROUS LACTATE |
|
1 kg |
1. |
LACTIC ACID - ANY<br>GRADE |
|
1.028 kg |
|
|
3 |
MAGNESIUM LACTATE |
|
1 kg |
1. |
LACTIC ACID - ANY<br>GRADE |
|
1.19 kg |
|
|
4 |
ZINC LACTATE |
|
1 kg |
1. |
LACTIC ACID - ANY<br>GRADE |
|
0.990 kg |
|
|
5 |
MAGNESIUM LACTATE<br>GLUCONATE |
|
1 kg |
1 |
LACTIC ACID -<br>ANY GRADE |
|
0.390 kg |
|
|
|
|
|
|
2 |
GLUCONO DELTA<br>LACTONE |
|
0.617 kg |
|
|
6 |
CALCIUM LACTATE |
|
1 kg |
1 |
LACTIC ACID –<br>ANY GRADE |
|
0.922 kg |
|
|
|
|
|
|
2 |
CALCIUM CARBONATE |
|
0.50 kg |
|
|
|
|
|
|
|
decision of NC. |
|
|
| 186 |
Case No.:534/15/82-<br>ALC4/2018 |
Party Name:YASH RASAYAN<br>& CHEMICALS |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/01991/AM19/ |
RLA File<br>:34/24/040/00184/AM19/ |
Lic.No/Date:3410044523<br>26.09.2018 |
|
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Vadodara |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Vadodara
52
|
|
Case No.:536/15/82- |
|
Party Name:YASH RASAYAN |
|
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
& CHEMICALS |
|
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
|
06.09.2019 |
|
|
| 187 |
|
HQ File<br>:01/82/050/01993/AM19/ |
|
RLA File<br>:34/24/040/00185/AM19/ |
|
|
Lic.No/Date:3410044524<br>26.09.2018 |
|
Defer Date |
|
|
**Decision:**The Committee |
noted that the 4.07 application |
|
of subject Advance Authorization is not |
|
|
|
|
|
|
available. Hence, it was decided |
to call for a copy of 4.07 application of the subject advance |
|
|
|
|
authorization |
|
|
|
from RLA,Vadodara. |
|
|
|
|
|
|
|
| Case No.:612/15/82- |
|
Party Name:MANGALAM |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
ORGANICS LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
(FORMERLY DUJODWALA |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310824148 |
|
Defer Date |
| :01/82/050/02069/AM19/ |
|
:03/95/040/00560/AM19/ |
|
03.10.2018 |
|
|
Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting 188 No. 3/82-ALC4/2019 dated 05.07..2019, followed by reminder on 02.08.2019
(i) Complete technical details as per Appendix 4E (ii) Catalogue of import item No. 2. .
In view of above, the Committee decided to issue Final Reminder to firm giving 15 days time to furnish its reply, failing which the case will be rejected.
| 189 |
<br>Case No.:562/15/82-<br>ALC4/2018<br>Party Name:ORTIN<br>LABORATORIES LTD<br>HQ File<br>:01/82/050/02019/AM19/<br>RLA File<br>:09/24/040/00302/AM19/<br>**Decision:**Deferred for comments of TE. |
Party Name:ORTIN<br>LABORATORIES LTD<br>RLA File<br>:09/24/040/00302/AM19/ |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
|
|
Lic.No/Date:0910066712<br>04.10.2018 |
|
|
|
|
|
|
| 190 |
<br>Case No.:563/15/82-<br>ALC4/2018<br>Party Name:S M S<br>PHARMACEUTICALS LTD<br>HQ File<br>:01/82/050/02020/AM19/<br>RLA File<br>:09/24/040/00318/AM19/<br>**Decision:**Deferred for comments of TE. |
Party Name:S M S<br>PHARMACEUTICALS LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
|
RLA File<br>:09/24/040/00318/AM19/ |
Lic.No/Date:0910066714<br>04.10.2018 |
Defer Date |
|
|
|
|
|
53
| 191 |
<br>Case No.:565/15/82-<br>ALC4/2018 |
Party Name:S M S<br>PHARMACEUTICALS LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02022/AM19/ |
RLA File<br>:09/24/040/00319/AM19/ |
Lic.No/Date:0910066716<br>04.10.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 192 |
Case No.:567/15/82-<br>ALC4/2018 |
Party Name:VERVE HUMAN<br>CARE LABORATORIES |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02024/AM19/ |
RLA File<br>:61/24/040/00009/AM19/ |
Lic.No/Date:6110001546<br>04.10.2018 |
Defer Date |
|
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide e-mail<br>dated 09.08.2019 has furnished its reply. Deferred for comments of TE. |
|
|
|
Case No.:569/15/82- Party Name:JODAS EXPOIM Meet No/Date:7/82- Status: ALC4/2018 PVT.LTD ALC4/2019 Deferred 06.09.2019 HQ File RLA File Lic.No/Date:0510408024 Defer Date 193 :01/82/050/02026/AM19/ :05/23/040/00297/AM19/ 08.10.2018
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.
Case No.:570/15/82- Party Name:JODAS EXPOIM Meet No/Date:7/82- Status: ALC4/2018 PVT.LTD ALC4/2019 Deferred 06.09.2019 HQ File RLA File Lic.No/Date:0510408025 Defer Date 194 :01/82/050/02027/AM19/ :05/23/040/00295/AM19/ 08.10.2018 Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA New Delhi.
| 195 |
<br>Case No.:572/15/82-<br>ALC4/2018 |
Party Name:A.R. LIFE<br>SCIENCES PVT LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02029/AM19/ |
RLA File<br>:09/24/040/00309/AM19/ |
Lic.No/Date:0910066726<br>08.10.2018 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
54
| Case No.:578/15/82- |
|
Party Name:SURVIVAL |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
TECHNOLOGIES PVT.LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310824348 |
|
|
| :01/82/050/02035/AM19/ |
|
:03/95/040/00679/AM19/ |
|
10.10.2018 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 196 applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| 1,2,3,4 - TETRAHYDRO |
1 kg |
1 |
SODIUM BOROHYDRIDE |
0.566 kg |
| - 1- NAPHTHOL |
|
2 |
DICHLOROMETHANE (Methylene |
6.00 kg |
| (ALPHA TETRALOL) |
|
|
Chloride / Methylene Dichloide) |
|
| 197 |
Case No.:582/15/82-<br>ALC4/2018 |
Party Name:MACSON<br>PRODUCTS |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02039/AM19/ |
RLA File<br>:52/24/040/00039/AM19/ |
Lic.No/Date:5210042796<br>11.10.2018 |
|
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Surat. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Surat.
| 198 |
Case No.:590/15/82-<br>ALC4/2018 |
Party Name:VERVE HUMAN<br>CARE LABORATORIES |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02047/AM19/ |
RLA File<br>:61/24/040/00011/AM19/ |
Lic.No/Date:6110001553<br>11.10.2018 |
|
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Dehradun. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Dehradun.
| 199 |
Case No.:801/15/82-<br>ALC4/2018 |
Party Name:DEEPAK<br>PHENOLICS LIMITED<br>RLA File<br>:34/24/040/00230/AM19/ |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Lic.No/Date:3410044580<br>11.10.2018 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02258/AM19/ |
|
|
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Vadodara. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Vadodara.
55
|
|
Case No.:592/15/82- |
|
Party Name:SRIAM LABS |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
PRIVATE LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 200 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910066753 |
|
Defer Date |
|
|
:01/82/050/02049/AM19/ |
|
:09/24/040/00338/AM19/ |
|
16.10.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
| Case No.:157/15/82- |
|
Party Name:VAKS PHARMA |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
PVT.LTD., |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310824491 |
|
Defer Date |
| :01/82/050/01614/AM19/ |
|
:03/95/040/00732/AM19/ |
|
17.10.2018 |
|
|
Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting 201 No. 3/82-ALC4/2019 dated 05.07.2019, followed by reminder on 02.08.2019:
(i) Whether the Soft Gelatin Capsules to be exported are empty or filled. (ii) In case of Filled Capsules, complete details of each type of capsules such as weight of empty capsules, weight of finished goods, their approved composition, wastage claimed etc. is to be furnished.
In view of above, the Committee decided to issue Final Reminder to firm giving 15 days time to furnish its reply, failing which the case will be rejected.
| Case No.:174/15/82- |
|
Party Name:VITAL |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
LABORATORIES PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310824501 |
|
|
| :01/82/050/01631/AM19/ |
|
:03/95/040/00527/AM19/ |
|
17.10.2018 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
202
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| 4- |
1 kg |
1 |
PARACHLORO BENZOPHENONE |
1.00 kg |
| CHLOROBENZHYDRIL<br>PIPERAZINE |
|
2 |
SODIUM BOROHYDRIDE |
0.06 kg |
|
|
3 |
PIPERAZINE ANHYDROUS |
1.00 kg |
56
| Case No.:178/15/82- |
|
Party Name:VITAL |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
LABORATORIES PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310824502 |
|
|
| :01/82/050/01635/AM19/ |
|
:03/95/040/00548/AM19/ |
|
17.10.2018 |
|
|
|
Case No.:178/15/82-<br>ALC4/2018 |
Case No.:178/15/82-<br>ALC4/2018 |
Party Name:VITAL<br>LABORATORIES PRIVATE<br>LIMITED |
Party Name:VITAL<br>LABORATORIES PRIVATE<br>LIMITED |
Party Name:VITAL<br>LABORATORIES PRIVATE<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/01635/AM19/ |
|
RLA File<br>:03/95/040/00548/AM19/ |
|
|
Lic.No/Date:0310824502<br>17.10.2018 |
|
| 203 |
<br>**Decision:**The Committee considered case as<br>was decided to ratify the ad-hoc input output n<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>ACYCLOVIR USP or<br>ACICLOVIR BP / EP<br>1 kg<br>1<br>2 |
|
|
|
per agenda in the presence of the technical experts and it<br>orms under para 4.7 of HBP as per details below or as<br>Import items<br>Qty.<br>GUANINE<br>1.20 kg<br>2-ACETOXY ETHYL ACETOXY<br>METHYL ETHER or 2-OXA-1,4-<br>BUTANEDIOL DIACETATE<br>0.90 kg<br>asper above decision of NC. |
|
|
|
|
Qty. |
|
Sl.<br>No. |
Import items |
|
|
|
|
1 kg |
|
1 |
GUANINE |
|
|
|
|
|
|
2 |
2-ACETOXY ETHYL ACETOXY<br>METHYL ETHER or 2-OXA-1,4-<br>BUTANEDIOL DIACETATE |
|
|
|
RA concerned maytake further necessaryaction |
|
|
|
asper above decision of NC. |
|
|
| 204 |
<br>Case No.:169/15/82-<br>ALC4/2018 |
Party Name:WOCKHARDT<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01626/AM19/ |
RLA File<br>:03/95/040/00755/AM19/ |
Lic.No/Date:0310824651<br>24.10.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 205 |
<br>Case No.:597/15/82-<br>ALC4/2018 |
Party Name:AUROBINDO<br>PHARMA LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02054/AM19/ |
RLA File<br>:09/24/040/00345/AM19/ |
Lic.No/Date:0910066762<br>25.10.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 206 |
<br>Case No.:599/15/82-<br>ALC4/2018 |
Party Name:LITMUS<br>ORGANICS P. LTD. |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02056/AM19/ |
RLA File<br>:03/95/040/00747/AM19/ |
Lic.No/Date:0310824684<br>25.10.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
57
| 207 |
<br>Case No.:602/15/82-<br>ALC4/2018 |
Party Name:GLAND<br>PHARMA LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02059/AM19/ |
RLA File<br>:09/24/040/00229/AM19/ |
Lic.No/Date:0910066775<br>26.10.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 208 |
<br>Case No.:603/15/82-<br>ALC4/2018 |
Party Name:THERAPIVA<br>PRIVATE LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02060/AM19/ |
RLA File<br>:09/24/040/00359/AM19/ |
Lic.No/Date:0910066778<br>26.10.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 209 |
<br>Case No.:604/15/82-<br>ALC4/2018 |
Party Name:ORTIN<br>LABORATORIES LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02061/AM19/ |
RLA File<br>:09/24/040/00347/AM19/ |
Lic.No/Date:0910066780<br>26.10.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 210 |
<br>Case No.:605/15/82-<br>ALC4/2018 |
Party Name:SUVEN LIFE<br>SCIENCES LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02062/AM19/ |
RLA File<br>:09/24/040/00354/AM19/ |
Lic.No/Date:0910066781<br>26.10.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
| 211 |
Case No.:608/15/82-<br>ALC4/2018 |
Party Name:MACSON<br>PRODUCTS |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02065/AM19/ |
RLA File<br>:52/24/040/00058/AM19/ |
Lic.No/Date:5210042821<br>26.10.2018 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Surat. |
|
|
|
58
| Case No.:164/15/82- |
|
Party Name:VN CREATIVE |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
CHEMICALS PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310824780 |
|
|
| :01/82/050/01621/AM19/ |
|
:03/95/040/00692/AM19/ |
|
29.10.2018 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 212 applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| Tonalid |
1 kg |
1 |
D M B-1 |
0.406 kg |
|
|
2 |
Paracymene |
0.648 kg |
| Case No.:610/15/82- |
|
Party Name:JODAS EXPOIM |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
PVT.LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510408268 |
|
|
| :01/82/050/02067/AM19/ |
|
:05/23/040/00334/AM19/ |
|
30.10.2018 |
|
|
|
Case No.:610/15/82-<br>ALC4/2018 |
Case No.:610/15/82-<br>ALC4/2018 |
Party Name:JODAS EXPOIM<br>PVT.LTD |
Party Name:JODAS EXPOIM<br>PVT.LTD |
Party Name:JODAS EXPOIM<br>PVT.LTD |
Party Name:JODAS EXPOIM<br>PVT.LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/02067/AM19/ |
|
RLA File<br>:05/23/040/00334/AM19/ |
|
|
|
Lic.No/Date:0510408268<br>30.10.2018 |
|
|
| 213 |
<br>**Decision:**The Committee considered case as per agenda and in the presence of the technical experts<br>and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per SION A-3659 or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Cefuroxime Sodium For Injection<br>750mg. NET Weight of Export Item<br>432.156 KG<br>1 Number<br>1<br>CEFUROXIME<br>SODIUM<br>RELEVANT BULK<br>DRUG<br>867.74 mg /<br>vial<br>Cefuroxime Sodium For Injection<br>1.5g. NET WEIGHT OF EXPORT<br>ITEM 432.158KG<br>1 Number<br>1<br>CEFUROXIME<br>SODIUM<br>RELEVANT BULK<br>DRUG<br>1735.48 mg /<br>vial<br>RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
|
Cefuroxime Sodium For Injection<br>750mg. NET Weight of Export Item<br>432.156 KG |
|
1 Number |
1 |
CEFUROXIME<br>SODIUM<br>RELEVANT BULK<br>DRUG |
|
867.74 mg /<br>vial |
|
|
|
Cefuroxime Sodium For Injection<br>1.5g. NET WEIGHT OF EXPORT<br>ITEM 432.158KG |
|
1 Number |
1 |
CEFUROXIME<br>SODIUM<br>RELEVANT BULK<br>DRUG |
|
1735.48 mg /<br>vial |
|
|
|
|
|
|
|
|
|
|
|
59
| Case No.:198/15/82- |
|
Party Name:RUMIT |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
LIFECARE |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310824932 |
|
|
| :01/82/050/01655/AM19/ |
|
:03/95/040/00737/AM19/ |
|
06.11.2018 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 214 applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| CLOBETASOL |
1 kg |
1 |
BETAMETHASONE 17 PROPIONATE |
1.00 kg |
| PROPIONATEUSP |
|
|
|
|
| 215 |
<br>Case No.:614/15/82-<br>ALC4/2018 |
Party Name:SUVEN LIFE<br>SCIENCES LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02071/AM19/ |
RLA File<br>:09/24/040/00360/AM19/ |
Lic.No/Date:0910066814<br>08.11.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 216 |
<br>Case No.:111/15/82-<br>ALC4/2018 |
Party Name:PUNJAB<br>CHEMICALS AND CROP<br>PROTECTION LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01568/AM19/ |
RLA File<br>:03/95/040/00709/AM19/ |
Lic.No/Date:0310824946<br>12.11.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:616/15/82- |
|
Party Name:VIVIMED LIFE |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
SCIENCES PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910066821 |
|
Defer Date |
| :01/82/050/02073/AM19/ |
|
:09/24/040/00387/AM19/ |
|
12.11.2018 |
|
|
217 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information:
(i) Copy of Master Batch Formula duly authenticated by Quality Control Incharge for each export item showing the net weight of each input in the export items. (ii) Drug Manufacturing license (DML) of the export product.
60
| 218 |
Case No.:87/15/82-ALC4/2018 |
Party Name:DEEPAK<br>NITRITE LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01544/AM19/ |
RLA File<br>:34/24/040/00267/AM19/ |
Lic.No/Date:3410044685<br>13.11.2018 |
Defer Date |
|
**Decision:**The Committee considered the case as per agenda<br>information from the firm:<br>(i) Percentageyield on molar basis at everystage. |
|
and it was decided to call for following |
|
Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm:
| 219 |
<br>Case No.:634/15/82-<br>ALC4/2018 |
Party Name:AUROBINDO<br>PHARMA LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02091/AM19/ |
RLA File<br>:09/24/040/00376/AM19/ |
Lic.No/Date:0910066832<br>13.11.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:622/15/82- |
|
Party Name:GLAND |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
PHARMA LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910066848 |
|
|
| :01/82/050/02079/AM19/ |
|
:09/24/040/00373/AM19/ |
|
14.11.2018 |
|
|
|
Case No.:622/15/82-<br>ALC4/2018 |
Case No.:622/15/82-<br>ALC4/2018 |
Party Name:GLAND<br>PHARMA LIMITED |
Party Name:GLAND<br>PHARMA LIMITED |
Party Name:GLAND<br>PHARMA LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/02079/AM19/ |
|
RLA File<br>:09/24/040/00373/AM19/ |
|
|
Lic.No/Date:0910066848<br>14.11.2018 |
|
|
| 220 |
<br>**Decision:**The Committee considered case as<br>was decided to ratify the ad-hoc input output n<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Esmolol Hydrochloride in<br>Sodium Chloride<br>Injection 2000 mg per<br>100ml (20mg per ml)<br>single dose bags<br>1<br>Number<br>1<br>2<br>3<br>Esmolol Hydrochloride in<br>Sodium Chloride<br>Injection 2500 mg per<br>250ml (10mg per ml)<br>single dose bags<br>1<br>Number<br>1<br>2<br>3 |
|
|
|
per agenda in the presence of<br>orms under para 4.7 of HBP |
|
the technical experts and it<br>as per details below or as |
|
|
|
Qty. |
|
Sl.<br>No. |
Import items |
|
Qty. per vial |
|
|
|
1<br>Number |
|
1 |
Esmolol Hydrochloride |
|
2100 mg |
|
|
|
|
|
2 |
100ml flexible bags |
|
Relevant as per packing<br>policy |
|
|
|
|
|
3 |
Twist off port stoppers |
|
Relevant as per packing<br>policy |
|
|
|
1<br>Number |
|
1 |
Esmolol Hydrochloride |
|
2625 mg |
|
|
|
|
|
2 |
250ml flexible bags |
|
Relevant as per packing<br>policy |
|
|
|
|
|
3 |
Twist off port stoppers |
|
Relevant as per packing<br>policy |
|
|
RA concerned maytake further necessaryaction |
|
|
|
asper above decision of NC. |
|
|
|
| 221 |
Case No.:623/15/82-<br>ALC4/2018 |
Party Name:VINS<br>BIOPRODUCTS LTD` |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02080/AM19/ |
RLA File<br>:09/24/040/00363/AM19/ |
Lic.No/Date:0910066851<br>14.11.2018 |
Defer Date |
|
**Decision:**A copy of application has been forwarded to DBT o<br>Comments awaited from DBT. |
|
n 17.07.2019 for obtaining its comments. |
|
61
| 222 |
<br>Case No.:627/15/82-<br>ALC4/2018 |
Party Name:AUROBINDO<br>PHARMA LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02084/AM19/ |
RLA File<br>:09/24/040/00382/AM19/ |
Lic.No/Date:0910066853<br>15.11.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 223 |
<br>Case No.:630/15/82-<br>ALC4/2018 |
Party Name:VIVIN DRUGS &<br>PHARMACEUTICALS<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02087/AM19/ |
RLA File<br>:09/24/040/00391/AM19/ |
Lic.No/Date:0910066856<br>15.11.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:631/15/82- |
|
Party Name:VIVIN DRUGS & |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
PHARMACEUTICALS |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910066857 |
|
|
| :01/82/050/02088/AM19/ |
|
:09/24/040/00392/AM19/ |
|
15.11.2018 |
|
|
|
Case No.:631/15/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/02088/AM19/ |
Party Name:VIVIN DRUGS &<br>PHARMACEUTICALS<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
|
RLA File<br>:09/24/040/00392/AM19/ |
Lic.No/Date:0910066857<br>15.11.2018 |
|
| 224 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>4-AMINO-2-OXO PYRIMIDINYL<br>OXATHIOLANE-2-<br>CARBOXYLIC<br>ACID<br>ISO PROPYL METHYL CYCLO<br>HEXYL ESTER (CEI-II)<br>1 kg<br>1<br>GLYOXYLIC ACID 50%<br>0.743 kg<br>2<br>2,5 DI HYDROXY 1,4<br>DITHIANE<br>0.325 kg<br>3<br>CYTOSINE<br>0.428 kg<br>4<br>HEXAMETHYL<br>DISILAZANE<br>0.509 kg<br>5<br>TRIETHYLAMINE<br>0.034 kg<br>6<br>METHYLENE<br>CHLORIDE<br>2.63 kg<br>7<br>L-MENTHOL<br>0.751 kg<br>8<br>TRIPHOSGENE<br>0.40 kg<br>9<br>TOLUENE<br>0.50 kg<br>10<br>N-HEXANE<br>1.13 kg<br>11<br>ETHYL ACETATE<br>1.00 kg<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as
| 225 |
<br>Case No.:2/15/82-ALC4/2018 |
Party Name:DEEPAK<br>NITRITE LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01459/AM19/ |
RLA File<br>:34/24/040/00254/AM19/ |
Lic.No/Date:3410044710<br>20.11.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
62
| 226 |
<br>Case No.:85/15/82-ALC4/2018 |
Party Name:DEEPAK<br>NITRITE LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01542/AM19/ |
RLA File<br>:34/24/040/00255/AM19/ |
Lic.No/Date:3410044711<br>20.11.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:86/15/82-ALC4/2018 |
|
Party Name:DEEPAK |
|
Meet No/Date:7/82- |
|
Status: |
|
|
NITRITE LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410044712 |
|
Defer Date |
| :01/82/050/01543/AM19/ |
|
:34/24/040/00256/AM19/ |
|
20.11.2018 |
|
|
Decision: The Committee considered the case as per agenda in the presence of technical experts and it 227 was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 3/82-ALC4/2019 dated 05.07.2019, followed by reminder on 02.08.2019
(i) Complete 4E with all technical details including chemistry, molecular weight, stoichiometric reaction and % of yield at every stage In view of above, the Committee decided to issue Final Reminder to firm giving 15 days time to furnish its reply, failing which the case will be rejected.
| 228 |
<br>Case No.:638/15/82-<br>ALC4/2018 |
Party Name:AUROBINDO<br>PHARMA LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02095/AM19/ |
RLA File<br>:09/24/040/00386/AM19/ |
Lic.No/Date:0910066874<br>20.11.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 229 |
<br>Case No.:639/15/82-<br>ALC4/2018 |
Party Name:CADILA<br>HEALTHCARE LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02096/AM19/ |
RLA File<br>:08/24/040/00187/AM19/ |
Lic.No/Date:0810143923<br>20.11.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 230 |
Case No.:640/15/82-<br>ALC4/2018 |
Party Name:AETHER<br>INDUSTRIES LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02097/AM19/ |
RLA File<br>:52/24/040/00064/AM19/ |
Lic.No/Date:5210042834<br>20.11.2018 |
Defer Date |
|
**Decision:**The Committee<br>available. Hence, it was decided<br>from RLA Surat. |
noted that the 4.07 application of subject Advance Authorization is not<br>to call for a copy of 4.07 application of the subject advance authorization |
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Surat.
Status:
231 Case No.:641/15/82- Party Name:HONEST BIOMeet No/Date:7/82-
63
|
ALC4/2018 |
VET PVT. LTD |
ALC4/2019<br>06.09.2019 |
Deferred<br>Defer Date |
|
HQ File<br>:01/82/050/02098/AM19/ |
RLA File<br>:08/24/040/00268/AM19/ |
Lic.No/Date:0810143924<br>20.11.2018 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 232 |
<br>Case No.:649/15/82-<br>ALC4/2018 |
Party Name:GLOBE<br>TROTTERS PVT LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02106/AM19/ |
RLA File<br>:03/94/040/00713/AM19/ |
Lic.No/Date:0310825212<br>26.11.2018 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:658/15/82- |
|
Party Name:ATHENA DRUG |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
DELIVERY SOLUTIONS |
|
ALC4/2019 |
|
Deferred |
|
|
PRIVATE LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310825255 |
|
Defer Date |
| :01/82/050/02115/AM19/ |
|
:03/94/040/00744/AM19/ |
|
28.11.2018 |
|
|
Decision: The Committee considered the case as per agenda in the presence of technical experts and it 233 was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 3/82-ALC4/2019 dated 21.06.2019, followed by reminder on 05.07.07.2019, followed by Reminder on 02.08.2019:
1 Export description does not tally with DML.
In view of above, the Committee decided to issue Final Reminder to firm giving 15 days time to furnish its reply, failing which the case will be rejected.
| 234 |
<br>Case No.:659/15/82-<br>ALC4/2018 |
Party Name:AUROBINDO<br>PHARMA LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02116/AM19/ |
RLA File<br>:09/24/040/00410/AM19/ |
Lic.No/Date:0910066905<br>28.11.2018 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 235 |
<br>Case No.:664/15/82-<br>ALC4/2018<br>Party<br>Name:SMILAX LABORATORIES LI<br>MITED<br>Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Status:<br>Deferred<br>HQ File<br>:01/82/050/02121/AM<br>19/<br>RLA File :09/24/040/00358/AM19/<br>Lic.No/Date:0910066915<br>28.11.2018<br>Defer Date<br>**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA Hyderabad. |
Party<br>Name:SMILAX LABORATORIES LI<br>MITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br> <br><br>Lic.No/Date:0910066915<br>28.11.2018<br> |
Status:<br>Deferred |
|
|
RLA File :09/24/040/00358/AM19/ |
|
Defer Date |
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Hyderabad.
236 Case No.:669/15/82-
Status:
Party Name:VERVE HUMAN Meet No/Date:7/82-
64
|
ALC4/2018 |
CARE LABORATORIES |
ALC4/2019<br>06.09.2019 |
Deferred |
|
HQ File<br>:01/82/050/02126/AM19/ |
RLA File<br>:61/24/040/00012/AM19/ |
Lic.No/Date:6110001560<br>28.11.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 237 |
<br>Case No.:670/15/82-<br>ALC4/2018 |
Party Name:VERVE HUMAN<br>CARE LABORATORIES |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02127/AM19/ |
RLA File<br>:61/24/040/00013/AM19/ |
Lic.No/Date:6110001561<br>28.11.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 238 |
<br>Case No.:671/15/82-<br>ALC4/2018 |
Party Name:VERVE HUMAN<br>CARE LABORATORIES |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02128/AM19/ |
RLA File<br>:61/24/040/00014/AM19/ |
Lic.No/Date:6110001562<br>28.11.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 239 |
<br>Case No.:672/15/82-<br>ALC4/2018 |
Party Name:VERVE HUMAN<br>CARE LABORATORIES<br>RLA File<br>:61/24/040/00015/AM19/ |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br> <br><br>Lic.No/Date:6110001563<br>28.11.2018<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02129/AM19/ |
|
|
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 240 |
<br>Case No.:673/15/82-<br>ALC4/2018 |
Party Name:VERVE HUMAN<br>CARE LABORATORIES |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02130/AM19/ |
RLA File<br>:61/24/040/00018/AM19/ |
Lic.No/Date:6110001564<br>28.11.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 241 |
<br>Case No.:674/15/82-<br>ALC4/2018 |
Party Name:VERVE HUMAN<br>CARE LABORATORIES |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02131/AM19/ |
RLA File<br>:61/24/040/00017/AM19/ |
Lic.No/Date:6110001565<br>28.11.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
65
| 242 |
<br>Case No.:675/15/82-<br>ALC4/2018 |
Party Name:VERVE HUMAN<br>CARE LABORATORIES |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02132/AM19/ |
RLA File<br>:61/24/040/00016/AM19/ |
Lic.No/Date:6110001566<br>28.11.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:210/15/82- |
|
Party Name:VENUS |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
REMEDIES LTD., |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:2210016020 |
|
|
| :01/82/050/01667/AM19/ |
|
:22/24/040/00064/AM19/ |
|
29.11.2018 |
|
|
|
Case No.:210/15/82-<br>ALC4/2018 |
Case No.:210/15/82-<br>ALC4/2018 |
Party Name:VENUS<br>REMEDIES LTD., |
Party Name:VENUS<br>REMEDIES LTD., |
Party Name:VENUS<br>REMEDIES LTD., |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/01667/AM19/ |
|
RLA File<br>:22/24/040/00064/AM19/ |
|
|
Lic.No/Date:2210016020<br>29.11.2018 |
|
| 243 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 15/82-ALC4/2019 dated 22.03.2019, it was decided to ratify norms under Para 4.7 of HBP v1<br>as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>CEFEPIME FOR<br>INJECTION USP 1.0 GM<br>EACH VIAL<br>CONTAINS: CEFEPIME<br>HYDROCHLORIDE<br>USP EQUIVALENT TO<br>CEFEPIME....1.00 GM<br>CONTAINING<br>CEFEPIME Hcl/L-<br>arginine sterile USP<br>1 Number<br>1<br>CEFEPIME<br>Hcl/L-arginine<br>sterile<br>USP (mixture of CEFEPIME HCL +<br>L-ARGININE STERILE USP)<br>1.8975 gm<br>/ vial<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
|
Qty. |
|
Sl.<br>No. |
Import items |
|
|
|
|
1 Number |
|
1 |
CEFEPIME<br>Hcl/L-arginine<br>sterile<br>USP (mixture of CEFEPIME HCL +<br>L-ARGININE STERILE USP) |
|
|
|
RA concerned maytake further necessaryaction as |
|
|
|
per above decision of NC. |
|
|
| 244 |
<br>Case No.:668/15/82-<br>ALC4/2018 |
Party Name:CADILA<br>HEALTHCARE LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02125/AM19/ |
RLA File<br>:08/24/040/00264/AM19/ |
Lic.No/Date:0810143988<br>29.11.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 245 |
<br>Case No.:689/15/82-<br>ALC4/2018 |
Party Name:AUROBINDO<br>PHARMA LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02146/AM19/ |
RLA File<br>:09/24/040/00421/AM19/ |
Lic.No/Date:0910066921<br>29.11.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
66
| Case No.:683/15/82- |
|
Party Name:NEON |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
LABORATORIES LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310825329 |
|
|
| :01/82/050/02140/AM19/ |
|
:03/95/040/00873/AM19/ |
|
30.11.2018 |
|
|
|
Case No.:683/15/82-<br>ALC4/2018 |
Case No.:683/15/82-<br>ALC4/2018 |
Party Name:NEON<br>LABORATORIES LTD. |
Party Name:NEON<br>LABORATORIES LTD. |
Party Name:NEON<br>LABORATORIES LTD. |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/02140/AM19/ |
|
RLA File<br>:03/95/040/00873/AM19/ |
|
|
Lic.No/Date:0310825329<br>30.11.2018 |
|
| 246 |
<br>**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and<br>in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by<br>NC<br>in<br>its<br>Meeting<br>No.<br>15/82-ALC4/2018<br>, dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Drug Formulations<br>Injections (ampoules/<br>vials upto 10 ML)<br>CISATRACURIUM<br>BESYLATE INJECTION<br>-2MG/ML-10ML.<br>8000 Nos.of Ampoules--<br>2MG/ML-10ML. Nett<br>content in the export<br>productis160 Gms.<br>1<br>Number<br>1<br>Relevant Bulk Drug<br>CISATRACURIUM BESYLATE<br>29.444 mg<br>/ 10 ml<br>vial<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
|
Qty. |
|
Sl.<br>No. |
Import items |
|
|
|
|
1<br>Number |
|
1 |
Relevant Bulk Drug<br>CISATRACURIUM BESYLATE |
|
|
|
RA concerned maytake further necessaryaction |
|
|
|
asper above decision of NC. |
|
|
| 247 |
<br>Case No.:684/15/82-<br>ALC4/2018 |
Party Name:GLAND<br>PHARMA LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02141/AM19/ |
RLA File<br>:09/24/040/00419/AM19/ |
Lic.No/Date:0910066930<br>03.12.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 248 |
<br>Case No.:685/15/82-<br>ALC4/2018 |
Party Name:GLAND<br>PHARMA LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02142/AM19/ |
RLA File<br>:09/24/040/00420/AM19/ |
Lic.No/Date:0910066931<br>03.12.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
67
| Case No.:686/15/82- |
|
Party Name:GENESYS |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
BIOLOGICS PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910066932 |
|
|
| :01/82/050/02143/AM19/ |
|
:09/24/040/00427/AM19/ |
|
03.12.2018 |
|
|
|
Case No.:686/15/82- |
Case No.:686/15/82- |
Party Name:GENESYS |
Party Name:GENESYS |
Party Name:GENESYS |
Meet No/Date:7/82- |
Status: |
|
<br>ALC4/2018 |
|
<br>BIOLOGICS PRIVATE<br>LIMITED |
|
|
<br>ALC4/2019<br>06.09.2019 |
<br>Approved |
|
HQ File |
|
RLA File |
|
|
Lic.No/Date:0910066932 |
|
|
<br>:01/82/050/02143/AM19/ |
|
<br>:09/24/040/00427/AM19/ |
|
|
<br>03.12.2018 |
|
|
**Decision:**The Committee c |
|
onsidered the case as per agend |
|
|
a and on the basis of writt |
en comments |
|
<br>furnished by Department of Biotechnology vide Office Memoran |
|
|
|
|
<br>dum No. BT/IL/05/002/201 |
<br>9-PID, dated |
|
16.09.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP<br>details below or as applied by firm whichever is lower: |
|
|
|
|
|
Vol. I as per |
| 249 |
<br>Export product<br>Q<br>INSULIN<br>1 |
|
|
|
|
|
Qty.<br>1.6 kg |
|
|
Q |
ty. |
Sl.<br>No. |
Import items |
|
|
|
|
1 |
k |
1 |
KROMASIL |
BULK |
|
|
<br> |
|
g |
|
<br>PART:KR100-1<br>MEDIA[Chem |
<br>3-C8 100A, 13UM,C8<br>ical item] |
|
|
|
|
|
2 |
RESIN<br> |
|
2.2 litres |
|
|
|
|
|
CM SEPHAROSE FAST FLOW 10L<br>CAT LOG NO:17071905 ( CANS<br>CONTAINING EACH 10 LTS) [11 |
|
|
|
|
|
|
|
<br>packages]. |
|
1.6 litres |
|
|
|
|
3 |
RESIN-SOURC<br>CAT<br>LOG |
E<br>30S,5L<br>NO.17127304<br>(CANS |
|
|
|
|
|
|
CONTAINING<br>packages] |
<br> <br>EACH<br>5LTS).[16 |
|
|
RA concerned maytake further necessaryaction |
|
|
|
asper above decision of NC. |
|
|
|
|
|
|
|
|
|
|
|
|
Case No.:688/15/82- |
|
Party Name:JODAS EXPOIM |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
PVT.LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 250 |
|
HQ File<br>:01/82/050/02145/AM19/ |
|
RLA File<br>:05/23/040/00385/AM19/ |
|
Lic.No/Date:0510408748<br>04.12.2018 |
|
Defer Date |
|
|
**Decision:**The Committee |
noted that the 4.07 application of subject Advance Authorization is not |
|
|
|
|
|
|
|
available. Hence, it was decided |
to call for a copy of 4.07 application of the subject advance |
|
|
|
authorization |
|
|
|
from CLA,New Delhi. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.
|
|
Case No.:691/15/82- |
|
Party Name:ORTIN |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
LABORATORIES LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 251 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910066937 |
|
Defer Date |
|
|
:01/82/050/02148/AM19/ |
|
:09/24/040/00423/AM19/ |
|
04.12.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
68
| 252 |
<br>Case No.:103/15/82-<br>ALC4/2018 |
Party Name:STERLING<br>AUXILIARIES PVT LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/01560/AM19/ |
RLA File<br>:03/95/040/00851/AM19/ |
Lic.No/Date:0310825462<br>05.12.2018 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:140/15/82- |
|
Party Name:YASHO |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310825441 |
|
|
| :01/82/050/01597/AM19/ |
|
:03/95/040/00911/AM19/ |
|
05.12.2018 |
|
|
| 253 |
Case No.:140/15/82-<br>ALC4/2018 |
Case No.:140/15/82-<br>ALC4/2018 |
Party Name:YASHO<br>INDUSTRIES LIMITED<br> <br> <br> |
Party Name:YASHO<br>INDUSTRIES LIMITED<br> <br> <br> |
Party Name:YASHO<br>INDUSTRIES LIMITED<br> <br> <br> |
Party Name:YASHO<br>INDUSTRIES LIMITED<br> <br> <br> |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br> <br><br>Lic.No/Date:0310825441<br>05.12.2018 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/01597/AM19/ |
|
RLA File<br>:03/95/040/00911/AM19/<br> <br> |
|
|
|
|
|
|
<br>**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by<br>NC<br>in<br>its<br>Meeting<br>No.<br>8/82-ALC4/2019<br>, dated 20.09.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>COPPER<br>DIBUTYL<br>DITHIOCARBAMATE(CDBC)<br>1 kg<br>1<br>DI-N-<br>BUTYLAMINE(DIBUTYLAMINE)<br>0.600 kg<br>2<br>CARBON DISULPHIDE<br>0.360 kg<br>3<br>COPPER SULPHATE<br>0.443 kg<br>RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
COPPER<br>DIBUTYL<br>DITHIOCARBAMATE(CDBC) |
|
1 kg |
1 |
DI-N-<br>BUTYLAMINE(DIBUTYLAMINE) |
|
0.600 kg |
|
|
|
|
|
2 |
CARBON DISULPHIDE |
|
0.360 kg |
|
|
|
|
|
3 |
COPPER SULPHATE |
|
0.443 kg |
|
|
|
|
|
|
Norms Committee |
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 8/82-ALC4/2019 , dated 20.09.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as 253 per details below or as applied by firm whichever is lower:
| 254 |
<br>Case No.:692/15/82-<br>ALC4/2018 |
Party Name:ORTIN<br>LABORATORIES LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02149/AM19/ |
RLA File<br>:09/24/040/00424/AM19/ |
Lic.No/Date:0910066938<br>05.12.2018 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 255 |
Case No.:696/15/82-<br>ALC4/2018 |
Party Name:AUROBINDO<br>PHARMA LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02153/AM19/ |
RLA File<br>:09/24/040/00436/AM19/ |
Lic.No/Date:0910066944<br>05.12.2018 |
|
|
**Decision:**The Committee considered the case as per agenda<br>information from the firm:<br>(i) Complete chemical name of the import item. |
|
and it was decided to call for following |
|
69
|
Case No.:744/15/82- |
Party Name:LUPIN LIMITED |
Meet No/Date:7/82- |
Status: |
| 256 |
<br>ALC4/2018 |
|
<br>ALC4/2019<br>06.09.2019 |
<br>Deferred |
|
<br>HQ File |
RLA File |
Lic.No/Date:0310825438 |
Defer Date |
|
<br> <br>:01/82/050/02201/AM19/ |
<br>:03/95/040/00876/AM19/ |
<br>05.12.2018 |
|
|
**Decision:**The Committee n |
oted that the 407 application o |
f subject Advance Authori |
zation is not |
|
.<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA Mumbai. |
|
|
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Mumbai.
|
Case No.:773/15/82- |
Party Name:LUPIN LIMITED |
Meet No/Date:7/82- |
Status: |
| 257 |
<br>ALC4/2018 |
|
<br>ALC4/2019<br>06.09.2019 |
<br>Deferred |
|
<br>HQ File |
RLA File<br>:03/95/040/00902/AM19/ |
Lic.No/Date:0310825460<br>05.12.2018 |
Defer Date |
|
<br> <br>:01/82/050/02230/AM19/ |
|
|
|
|
**Decision:**The Committee n |
ted that the 407 application o |
subject Advance Authori |
zation is not |
|
.<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA Mumbai. |
|
|
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Mumbai.
|
|
|
Case No.:186/15/82- |
|
Party Name:WOCKHARDT |
|
Meet No/Date:7/82- |
|
Status: |
|
|
|
|
ALC4/2018 |
|
LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
|
|
06.09.2019 |
|
|
|
|
258 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310825487 |
|
Defer Date |
|
|
|
|
:01/82/050/01643/AM19/ |
|
:03/95/040/00900/AM19/ |
|
06.12.2018 |
|
|
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Case No.:698/15/82- |
|
Party Name:VISION DRUGS |
|
Meet No/Date:7/82- |
|
Status: |
|
|
|
|
ALC4/2018 |
|
PVT LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
|
|
06.09.2019 |
|
|
|
|
259 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910066949 |
|
Defer Date |
|
|
|
|
:01/82/050/02155/AM19/ |
|
:09/24/040/00412/AM19/ |
|
06.12.2018 |
|
|
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Case No.:700/15/82- |
|
Party Name:J.B. CHEMICALS |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
& PHARMACEUTICALS |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
06.09.2019 |
|
|
| 260 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310825472 |
|
Defer Date |
|
|
:01/82/050/02157/AM19/ |
|
:03/94/040/00748/AM19/ |
|
06.12.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
70
|
Case No.:185/15/82- |
|
Party Name:YASHO |
|
Meet No/Date:7/82- |
|
Status: |
|
ALC4/2018 |
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
06.09.2019 |
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310825514 |
|
Defer Date |
|
:01/82/050/01642/AM19/ |
|
:03/95/040/00925/AM19/ |
|
07.12.2018 |
|
|
261 Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm:
(i) Complete 4E with all technical details i.e chemistry, molecular weight, stoichiometric reaction and % of yield on molar basis at every stage.
| 262 |
<br>Case No.:88/15/82-ALC4/2018 |
Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01545/AM19/ |
RLA File<br>:03/94/040/00774/AM19/ |
Lic.No/Date:0310825559<br>10.12.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
Case No.:703/15/82- Party Name:SRINI Meet No/Date:7/82- Status: ALC4/2018 PHARMACEUTICALS ALC4/2019 Approved PRIVATE LIMITED 06.09.2019 HQ File RLA File Lic.No/Date:0910066958 :01/82/050/02160/AM19/ :09/24/040/00413/AM19/ 10.12.2018 Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
|
Case No.:703/15/82-<br>ALC4/2018 |
Case No.:703/15/82-<br>ALC4/2018 |
Party Name:SRINI<br>PHARMACEUTICALS<br>PRIVATE LIMITED |
Party Name:SRINI<br>PHARMACEUTICALS<br>PRIVATE LIMITED |
Party Name:SRINI<br>PHARMACEUTICALS<br>PRIVATE LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/02160/AM19/ |
|
RLA File<br>:09/24/040/00413/AM19/ |
|
|
Lic.No/Date:0910066958<br>10.12.2018 |
|
| 263 |
<br>**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and<br>in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by<br>NC<br>in<br>its<br>Meeting<br>No.<br>15/82-ALC4/2018<br>, dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>LEVOFLOXACIN<br>HEMIHYDRATE<br>1 kg<br>1<br>9,10-DIFLUORO-2,3-DIHYDRO-3-<br>METHYL-7-OXO-(3S)-7H-<br>PYRIDO[1,2,3-DE]-1,4-<br>BENZOXAZINE-6-CARBOXYLIC<br>ACID(LVF 40)<br>0.857 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
|
Qty. |
|
Sl.<br>No. |
Import items |
|
|
|
|
1 kg |
|
1 |
9,10-DIFLUORO-2,3-DIHYDRO-3-<br>METHYL-7-OXO-(3S)-7H-<br>PYRIDO[1,2,3-DE]-1,4-<br>BENZOXAZINE-6-CARBOXYLIC<br>ACID(LVF 40) |
|
|
|
RA concerned maytake further necessaryaction |
|
|
|
asper above decision of NC. |
|
|
71
| Case No.:706/15/82- |
|
Party Name:J.B. CHEMICALS |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
& PHARMACEUTICALS |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310825552 |
|
|
| :01/82/050/02163/AM19/ |
|
:03/94/040/00773/AM19/ |
|
10.12.2018 |
|
|
|
Case No.:706/15/82-<br>ALC4/2018 |
Case No.:706/15/82-<br>ALC4/2018 |
Case No.:706/15/82-<br>ALC4/2018 |
Case No.:706/15/82-<br>ALC4/2018 |
Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED |
Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/02163/AM19/ |
|
|
|
RLA File<br>:03/94/040/00773/AM19/ |
|
Lic.No/Date:0310825552<br>10.12.2018 |
|
|
|
| 264 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less:<br>Sl.<br>No.<br>Export Product<br>Qty.<br>1<br>GLIPIZIDE EXTENDED RELEASE TABLETS 10 MG.Each tablet contains (i)<br>Glipizide USP- 10 mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 29.70 mg (iii) Sentry<br>Polyox WSR N80 FP NF- 178.10 mg (iv) Sentry Polyox WSR 303 NF- 100 mg. Net<br>content (i) 201.667 Kgs (ii) 598.951 Kgs (iii) 3591.689 Kgs (iv) 2016.670 Kgs.<br>1<br>Number<br>2<br>GLIPIZIDE EXTENDED RELEASE TABLETS 5 MG. Each tablet contains (i)<br>Glipizide USP- 5 mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 20.40 mg (iii) Sentry<br>Polyox WSR N80 FP NF- 89.05 mg (iv) Sentry Polyox WSR 303 NF- 50 mg. Net<br>content (i) 83.334 Kgs (ii) 340.001 Kgs (iii) 1484.170 Kgs (iv) 833.335 Kgs.<br>1<br>Number<br>3<br>GLIPIZIDE EXTENDED RELEASE TABLETS 2.5 MG. Each tablet contains (i)<br>Glipizide USP- 2.5 mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 20.40 mg (iii) Sentry<br>Polyox WSR N80 FP NF- 89.05 mg (iv) Sentry Polyox WSR 303 NF- 50 mg. Net<br>content (i) 53.340 Kgs (ii) 435.254 Kgs (iii) 1899.971 Kgs (iv) 1066.800 Kgs.<br>1<br>Number<br>Sl.<br>No.<br>Import Items<br>For export of 1 Number of Tablet<br>2.5 mg<br>5.0 mg<br>10.0 mg<br>1<br>GLIPIZIDE USP<br>2.55 mg<br>5.10 mg<br>10.20 mg<br>2<br>EASTMAN (TM) CELLULOSE<br>ACETATE (CA 398-10NF/EP)<br>20.40 mg<br>20.40 mg<br>29.70 mg<br>3<br>SENTRY POLYOX WSR N80 FP NF<br>89.05 mg<br>89.05 mg<br>178.10 mg<br>4<br>SENTRY POLYOX WSR 303 NF<br>50.00 mg<br>50.00 mg<br>100.00 mg<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
|
|
|
|
|
Sl.<br>No. |
Export Product |
|
|
|
|
|
|
Qty. |
|
|
1 |
GLIPIZIDE EXTENDED RELEASE TABLETS 10 MG.Each tablet contains (i)<br>Glipizide USP- 10 mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 29.70 mg (iii) Sentry<br>Polyox WSR N80 FP NF- 178.10 mg (iv) Sentry Polyox WSR 303 NF- 100 mg. Net<br>content (i) 201.667 Kgs (ii) 598.951 Kgs (iii) 3591.689 Kgs (iv) 2016.670 Kgs. |
|
|
|
|
|
|
<br>1<br>Number |
|
|
2 |
GLIPIZIDE EXTENDED RELEASE TABLETS 5 MG. Each tablet contains (i)<br>Glipizide USP- 5 mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 20.40 mg (iii) Sentry<br>Polyox WSR N80 FP NF- 89.05 mg (iv) Sentry Polyox WSR 303 NF- 50 mg. Net<br>content (i) 83.334 Kgs (ii) 340.001 Kgs (iii) 1484.170 Kgs (iv) 833.335 Kgs. |
|
|
|
|
|
|
1<br>Number |
|
|
3 |
GLIPIZIDE EXTENDED RELEASE TABLETS 2.5 MG. Each tablet contains (i)<br>Glipizide USP- 2.5 mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 20.40 mg (iii) Sentry<br>Polyox WSR N80 FP NF- 89.05 mg (iv) Sentry Polyox WSR 303 NF- 50 mg. Net<br>content (i) 53.340 Kgs (ii) 435.254 Kgs (iii) 1899.971 Kgs (iv) 1066.800 Kgs. |
|
|
|
|
|
|
1<br>Number |
|
|
|
|
|
|
|
|
|
|
|
|
|
Sl.<br>No. |
|
Import Items |
|
For export of 1 Number of Tablet |
|
|
|
|
|
|
|
|
|
|
2.5 mg |
|
5.0 mg |
10.0 mg |
|
|
|
1 |
|
GLIPIZIDE USP |
|
2.55 mg |
|
5.10 mg |
10.20 mg |
|
|
|
2 |
|
EASTMAN (TM) CELLULOSE<br>ACETATE (CA 398-10NF/EP) |
|
20.40 mg |
|
20.40 mg |
29.70 mg |
|
|
|
3 |
|
SENTRY POLYOX WSR N80 FP NF |
|
89.05 mg |
|
89.05 mg |
178.10 mg |
|
|
|
4 |
|
SENTRY POLYOX WSR 303 NF |
|
50.00 mg |
|
50.00 mg |
100.00 mg |
|
|
|
|
|
|
|
|
|
|
|
|
| 265 |
Case No.:715/15/82-<br>ALC4/2018 |
Party Name:MALLADI<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02172/AM19/ |
RLA File<br>:04/24/040/00143/AM19/ |
Lic.No/Date:0410164962<br>10.12.2018 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA Chennai. |
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Chennai.
| 266 |
<br>Case No.:139/15/82-<br>ALC4/2018 |
Party Name:RUBICON<br>RESEARCH PRIVATE<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br> <br><br>Lic.No/Date:0310825587<br>11.12.2018<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01596/AM19/ |
RLA File<br>:03/95/040/00889/AM19/ |
|
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
72
|
|
Case No.:711/15/82- |
|
Party Name:SUVEN LIFE |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
SCIENCES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 267 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910066959 |
|
Defer Date |
|
|
:01/82/050/02168/AM19/ |
|
:09/24/040/00441/AM19/ |
|
11.12.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
| Case No.:106/15/82- |
|
Party Name:SONGWON |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
SPECIALTY CHEMICALS |
|
ALC4/2019 |
|
Deferred |
|
|
INDIA PVT. LTD. |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410044750 |
|
Defer Date |
| :01/82/050/01563/AM19/ |
|
:34/24/040/00294/AM19/ |
|
12.12.2018 |
|
|
Decision: The Committee considered the case as per agenda in the presence of technical experts and it 268 was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 3/82-ALC4/2019 dated 05.07.2019, followed by reminder on 02.08.2019:
(i) Complete technical details as per Appendix 4E.
In view of above, the Committee decided to issue Final Reminder to firm giving 15 days time to furnish its reply, failing which the case will be rejected.
| Case No.:152/15/82- |
|
Party Name:PRASOL |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
CHEMICALS PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310825623 |
|
|
| :01/82/050/01609/AM19/ |
|
:03/95/040/00948/AM19/ |
|
12.12.2018 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 269 applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| 2-METHYL-1,3-PENTADIENE (METHYL-2- |
1 kg |
1 |
ACETONE |
3.32 kg |
| PENTADIENE / 2MPD) |
|
|
|
|
The above norms are allowed on one time basis and no repeat licence shall be issued. RA may take appropriate action as per the decision of Norms Committee.
270
|
Case No.:189/15/82- |
|
Party Name:TATA |
|
Meet No/Date:7/82- |
|
Status: |
|
ALC4/2018 |
|
CHEMICALS LIMITED |
|
ALC4/2019 |
|
Transferred |
|
|
|
|
|
06.09.2019 |
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310825645 |
|
|
|
:01/82/050/01646/AM19/ |
|
:03/95/040/00901/AM19/ |
|
13.12.2018 |
|
|
Decision: The Committee considered the case as per agenda and it was observed that the export product – Fossence (Oligofructose / FOS ) Powder P 90 / Liquid L95 comes under Food category, not pharmaceutical.
, the Committee decided to transfer the case to NC-VI .
73
| 271 |
<br>Case No.:721/15/82-<br>ALC4/2018 |
Party Name:VERVE HUMAN<br>CARE LABORATORIES |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Lic.No/Date:6110001570<br>13.12.2018 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02178/AM19/ |
RLA File<br>:61/24/040/00020/AM19/ |
|
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 272 |
<br>Case No.:726/15/82-<br>ALC4/2018 |
Party Name:NATCO PHARMA<br>LIMITED |
<br>Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02183/AM19/ |
RLA File<br>:09/24/040/00417/AM19/ |
Lic.No/Date:0910066973<br>18.12.2018 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 273 |
<br>Case No.:727/15/82-<br>ALC4/2018 |
Party Name:AUROBINDO<br>PHARMA LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02184/AM19/ |
RLA File<br>:09/24/040/00443/AM19/ |
Lic.No/Date:0910066974<br>18.12.2018 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:732/15/82- |
|
Party Name:ASHISH LIFE |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
SCIENCE PVT.LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310825741 |
|
|
| :01/82/050/02189/AM19/ |
|
:03/94/040/00719/AM19/ |
|
18.12.2018 |
|
|
|
Case No.:732/15/82-<br>ALC4/2018 |
Party Name:ASHISH LIFE<br>SCIENCE PVT.LTD. |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/02189/AM19/ |
RLA File<br>:03/94/040/00719/AM19/ |
Lic.No/Date:0310825741<br>18.12.2018 |
|
| 274 |
<br>**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as<br>per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>BENZYL PENICILLIN FOR<br>INJECTION<br>(EACH VIAL CONTAINS<br>BENZYL PENICILLIN<br>SODIUM EQ. TO BENZYL<br>PENICILLIN 5000000 I.U.)<br>(3000MG) (NETT CONTENT<br>OF EXEMPTED MATERIAL IS<br>625.50 KGS EQ. TO 1042.50<br>BOU)<br>208500 Number<br>1<br>BENZYL<br>PENICILLIN<br>SODIUM<br>RAW<br>MATERIAL<br>688.05 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
74
| 275 |
<br>Case No.:735/15/82-<br>ALC4/2018 |
Party Name:CIPLA LIMITED. |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02192/AM19/ |
RLA File<br>:03/94/040/00753/AM19/ |
Lic.No/Date:0310825758<br>18.12.2018 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 276 |
<br>Case No.:736/15/82-<br>ALC4/2018 |
Party Name:AMI ORGANICS<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02193/AM19/ |
RLA File<br>:52/24/040/00068/AM19/ |
Lic.No/Date:5210042870<br>18.12.2018 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 277 |
<br>Case No.:99/15/82-ALC4/2018 |
Party Name:SUN<br>PHARMACEUTICAL<br>INDUSTRIES LTD. |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/01556/AM19/ |
RLA File<br>:05/24/040/00503/AM19/ |
Lic.No/Date:0510408988<br>19.12.2018 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
| 278 |
<br>Case No.:738/15/82-<br>ALC4/2018 |
Party Name:VIVIMED LABS<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02195/AM19/ |
RLA File<br>:09/24/040/00460/AM19/ |
Lic.No/Date:0910066983<br>19.12.2018 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 279 |
<br>Case No.:1025/15/82-<br>ALC4/2018 |
Party Name:ANLON<br>HEALTHCARE<br>PRIVATELIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Lic.No/Date:2410042604<br>19.12.2018 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02482/AM19/ |
RLA File<br>:24/24/040/00044/AM19/ |
|
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 280 |
Case No.:742/15/82-<br>ALC4/2018 |
Party Name:BEST VALUE<br>CHEM PVT. LTD.<br> <br> <br> |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>S<br><br>Lic.No/Date:3410044774<br>20.12.2018<br> |
tatus:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02199/AM19/ |
RLA File<br>:34/24/040/00295/AM19/<br> <br> |
|
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA Vadodara. |
|
|
|
75
|
|
Case No.:743/15/82- |
|
Party Name:SHUBHLAXMI |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
INDUSTRIES |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 281 |
|
HQ File<br>:01/82/050/02200/AM19/ |
|
RLA File<br>:08/24/040/00267/AM19/ |
|
Lic.No/Date:0810144119<br>20.12.2018 |
|
Defer Date |
|
|
**Decision:**The Committee |
noted that the 4.07 application |
|
|
of subject Advance Authorization is not |
|
|
|
|
available. Hence, it was decided |
|
to call for a copy of 4.07 application of the subject advance authorization |
|
|
|
|
|
|
from RLA Ahmedabad. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Ahmedabad.
| Case No.:745/15/82- |
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Party Name:CIPLA LIMITED. |
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Meet No/Date:7/82- |
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Status: |
| ALC4/2018 |
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|
|
ALC4/2019 |
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Approved |
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06.09.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0310825817 |
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| :01/82/050/02202/AM19/ |
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:03/94/040/00782/AM19/ |
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20.12.2018 |
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Case No.:743/15/82- |
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Part |
Name:SHUBHLAXMI |
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Meet No/Date:7/82- |
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Status: |
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<br>ALC4/2018 |
|
<br>IND |
<br>USTRIES |
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<br>ALC4/2019 |
|
<br>Deferred |
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06.09.2019 |
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| 281 |
<br>HQ File<br>:01/82/050/02200/AM19/ |
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RLA<br>:08/2 |
il |
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i114411 |
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f |
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Fe<br>4/040/00267/AM19/ |
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Lc.No/Date:0809<br>20122018 |
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Deer Date |
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.. |
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**Decision:**The Committee note<br>available. Hence, it was decided to c<br>from RLA Ahmedabad. |
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d that the 4.07 application<br> |
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of subject Advance Authorization is not<br> |
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all for a copy of 4.07 application of the subject advance authorization |
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Case No.:745/15/82-<br>ALC4/2018 |
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Party |
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Name:CIPLA LIMITED. |
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Meet No/Date:7/82-<br>ALC4/2019 |
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Status:<br>Approved |
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06.09.2019 |
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HQ File<br>:01/82/050/02202/AM19/ |
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RLA<br>:03/9 |
File<br>4/040/00782/AM19/ |
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Lic.No/Date:0310825817<br>20.12.2018 |
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**Decision:**The Committee conside<br>meeting no. 06/82-ALC4/2019 dated<br>as per details given below or as appli |
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red the cases as per agenda and in the light of earlier decision taken in<br>16.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1<br>ed by the firm, whichever is less: |
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Sl.<br>Import items<br>Qty. |
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Export Product |
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Qty. |
Sl. |
Import items |
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Qty. |
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No. |
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Budesonide Inhalation Suspensio |
|
n |
1 Number |
1 |
Budesonide USP |
|
0.2625 mg / 0.25 |
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<br>0.25mg/2ml Budesonide Respul |
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<br>es |
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<br>mg vial |
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|
<br>0.25mg/2ml |
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2 |
PURELL PE |
|
<br>Relevant, as per |
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<br>(Each 2ml contains Budesoni<br>USP 0.25mg) |
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de |
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1840H |
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<br>Packing Policy on |
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GRANULES |
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<br>the net weight of |
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| 282 |
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empty respules ( |
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Net + 5% ) |
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Budesonide Inhalation Suspensio<br> |
|
n<br> |
1 Number |
1 |
Budesonide USP |
|
0.525 mg / 0.50<br> |
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0.50mg/2ml Budesonide Respul<br>0.50mg/2ml |
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es |
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mg vial |
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2 |
PURELL PE |
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Relevant as per |
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<br>(Each 2ml contains Budesoni<br>USP 0.50mg) |
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de |
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<br>1840H<br>GRANULES |
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,<br>Packing Policy on<br>the net weight of<br>empty respules (<br>Net + 5% ) |
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Budesonide Inhalation Suspension<br>1mg/2ml<br>Budesonide<br>Respules<br>1mg/2ml<br>(Each 2ml contains Budesonide<br>USP 1mg) |
|
|
1 Number |
1 |
Budesonide USP |
|
<br>1.05 mg / 1 mg<br>vial |
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2 |
PURELL PE<br>1840H<br>GRANULES |
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Relevant, as per<br>Packing Policy on<br>the net weight of<br>t l ( |
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empy respues<br>Net + 5% )<br>RA concerned maytake further necessaryaction asper above decision of NC. |
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empy respues<br>Net + 5% ) |
|
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Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 06/82-ALC4/2019 dated 16.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
76
| 283 |
Case No.:748/15/82-<br>ALC4/2018 |
Party Name:SPANSULES<br>FORMULATIONS |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02205/AM19/ |
RLA File<br>:09/24/040/00418/AM19/ |
Lic.No/Date:0910066987<br>20.12.2018 |
Defer Date |
|
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide e-mail<br>dated 03.09.2019 has furnished its reply. Deferred for comments of TE. |
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Case No.:752/15/82- |
|
Party Name:ATUL LIMITED, |
|
Meet No/Date:7/82- |
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Status: |
|
|
ALC4/2018 |
|
|
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 284 |
|
HQ File<br>:01/82/050/02209/AM19/ |
|
RLA File<br>:08/24/040/00303/AM19/ |
|
Lic.No/Date:0810144142<br>21.12.2018 |
|
Defer Date |
|
|
**Decision:**The Committee |
noted that the 4.07 application of subject Advance Authorization is not |
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|
|
|
available. Hence, it was decided |
|
to call for a copy of 4.07 application of the subject advance |
|
|
|
authorization |
|
|
from RLA Ahmedabad. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA Ahmedabad.
| Case No.:126/15/82- |
|
Party Name:POLYGEL |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
INDUSTRIES PVT.LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310825887 |
|
Defer Date |
| :01/82/050/01583/AM19/ |
|
:03/95/040/00969/AM19/ |
|
24.12.2018 |
|
|
Decision: The Committee considered the case as per agenda in the presence of technical experts and it 285 was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 3/82-ALC4/2019 dated 05.07.2019, followed by reminder on 01.08.2019
(i) Exact chemical name of import item No. 2 (ii) Catalogue of import item No. 2.
In view of above, the Committee decided to issue Final Reminder to firm giving 15 days time to furnish its reply, failing which the case will be rejected.
|
|
Case No.:925/15/82- |
|
Party Name:OPTRIX |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
LABORATORIES PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
06.09.2019 |
|
|
| 286 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910066998 |
|
Defer Date |
|
|
:01/82/050/02382/AM19/ |
|
:09/24/040/00470/AM19/ |
|
24.12.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
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|
|
|
77
| Case No.:762/15/82- |
|
Party Name:HPL ADDITIVES |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
LIMITED(FORMERLY |
|
ALC4/2019 |
|
Approved |
|
|
KNOWN HIGH POLYMER |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510409068 |
|
|
| :01/82/050/02219/AM19/ |
|
:05/23/040/00403/AM19/ |
|
26.12.2018 |
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018 287 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
| Export Product |
Qty. |
Sl.No. |
Import items |
Qty.<br>0.437 kg |
| 1,3 Dibromo 5,5 Dimethyl<br>Hydantoin |
1 kg |
1 |
Acetone Cyanohydrin |
|
| 288 |
<br>Case No.:767/15/82-<br>ALC4/2018<br> <br> <br>HQ File<br>:01/82/050/02224/AM19/<br> <br> |
Party Name:CIPLA<br>LIMITED. |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
|
RLA File<br>:03/94/040/00826/AM19/ |
Lic.No/Date:0310825972<br>27.12.2018 |
<br>Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
| 289 |
<br>Case No.:772/15/82-<br>ALC4/2018<br> <br> <br>HQ File<br>:01/82/050/02229/AM19/<br> <br> |
Party Name:AUROBINDO<br>PHARMA LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
|
RLA File<br>:09/24/040/00445/AM19/ |
Lic.No/Date:0910067006<br>31.12.2018 |
<br>Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 290 |
<br>Case No.:775/15/82-<br>ALC4/2018 |
Party Name:SUVEN LIFE<br>SCIENCES LIMITED<br>RLA File<br>:09/24/040/00482/AM19/ |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02232/AM19/ |
|
Lic.No/Date:0910067014<br>31.12.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
78
| Case No.:6/7/82-ALC4/2019 |
|
Party Name:GLOBAL |
|
Meet No/Date:7/82- |
|
Status: |
|
|
CALCIUM PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710114343 |
|
|
| :01/82/050/00501/AM20/ |
|
:07/24/040/00224/AM19/ |
|
31.12.2018 |
|
|
Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as 291 per details below or as applied by firm whichever is lower:
| Export product<br>CALCIUM<br>GLUCONATE<br>-<br>POWDER |
Qty.<br>118 M.T. |
Sl. No.<br>1 |
Import items<br>CALCIUM<br>GLUCONATE -<br>GRANULAR |
Qty.<br>118 M.T. |
| Case No.:7/7/82-ALC4/2019 |
|
Party Name:GLOBAL |
|
Meet No/Date:7/82- |
|
Status: |
|
|
CALCIUM PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710114344 |
|
|
| :01/82/050/00502/AM20/ |
|
:07/24/040/00221/AM19/ |
|
31.12.2018 |
|
|
|
Case No.:7/7/82-ALC4/2019 |
Case No.:7/7/82-ALC4/2019 |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00502/AM20/ |
|
RLA File<br>:07/24/040/00221/AM19/ |
|
|
Lic.No/Date:0710114344<br>31.12.2018 |
|
|
| 292 |
**Decision:**The Committee considered case as<br>experts, it was decided to ratify the ad-hoc input<br>4/82-ALC4/2018 meeting dated 19.06.2018 under<br>firm whichever is lower: |
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|
|
per agenda and and in the presence of<br>output norms as per earlier decision taken<br>para 4.7 of HBP as per details below or a |
|
|
the technical<br>by NC in its<br>s applied by |
|
Sl.<br>No. |
Export Product |
|
Qty. |
Import Items |
|
Qty. |
|
|
1 |
MAGNESIUM LACTATE<br>GLUCONATE |
|
1 kg |
GLUCONO DELTA LACTONE |
|
0.755 kg |
|
|
2 |
ZINC GLUCONATE<br>(Eur.Ph/USP) |
|
1 kg |
GLUCONO DELTA LACTONE |
|
0.945 kg |
|
|
3 |
MAGNESIUM GLUCONATE<br>(Eur.Ph/USP) |
|
1 kg |
GLUCONO DELTA LACTONE |
|
0.945 kg |
|
|
4 |
POTASSIUM GLUCONATE<br>(USP) |
|
1 kg |
GLUCONO DELTA LACTONE |
|
0.930 kg |
|
|
5 |
FERROUS GLUCONATE<br>(BP/EP/USP) |
|
1 kg |
GLUCONO DELTA LACTONE |
|
0.887 kg |
|
|
6 |
MANGANESE GLUCONATE<br>(Eur.Ph/USP) |
|
1 kg |
GLUCONO DELTA LACTONE |
|
0.945 kg |
|
|
7 |
CALCIUM MAGNESIUM<br>LACTATE GLUCONATE |
|
1 kg |
GLUCONO DELTA LACTONE |
|
0.831 kg |
|
|
RA maytake appropriate action asper the decision |
|
|
|
of Norms Committee |
|
|
|
79
|
|
Case No.:8/7/82-ALC4/2019 |
|
|
Party Name:GLOBAL |
|
Meet No/Date:7/82- |
|
Status: |
|
|
|
|
|
CALCIUM PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
LIMITED |
|
06.09.2019 |
|
|
| 293 |
|
HQ File<br>:01/82/050/00503/AM20/ |
|
|
RLA File<br>:07/24/040/00223/AM19/ |
|
Lic.No/Date:0710114345<br>31.12.2018 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
|
not available. Hence, it was |
decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
|
|
authorization from RLA,Bangalore. |
|
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Bangalore.
|
|
Case No.:9/7/82-ALC4/2019 |
|
|
Party Name:GLOBAL |
|
Meet No/Date:7/82- |
|
Status: |
|
|
|
|
|
CALCIUM PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
LIMITED |
|
06.09.2019 |
|
|
| 294 |
|
HQ File<br>:01/82/050/00504/AM20/ |
|
|
RLA File<br>:07/24/040/00222/AM19/ |
|
Lic.No/Date:0710114346<br>31.12.2018 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
|
not available. Hence, it was |
decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
|
|
authorization from RLA,Bangalore. |
|
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Bangalore.
|
|
Case No.:784/15/82- |
|
Party Name:SMS |
|
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
LIFESCIENCES INDIA |
|
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
|
06.09.2019 |
|
|
| 295 |
|
HQ File<br>:01/82/050/02241/AM19/ |
|
RLA File<br>:09/24/040/00490/AM19/ |
|
|
Lic.No/Date:0910067021<br>01.01.2019 |
|
Defer Date |
|
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not |
|
|
|
|
|
|
|
|
|
available. Hence, it was decided to call for a copy of 4.07 |
|
|
application of the subject advance authorization |
|
|
|
|
|
|
from RLA,Hyderabad. |
|
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
|
|
Case No.:788/15/82- |
|
Party Name:MANKIND |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
PHARMA LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 296 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0510409149 |
|
Defer Date |
|
|
:01/82/050/02245/AM19/ |
|
:05/24/040/00552/AM19/ |
|
02.01.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:792/15/82- |
|
Party Name:BIOLOGICAL E |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 297 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910067026 |
|
Defer Date |
|
|
:01/82/050/02249/AM19/ |
|
:09/24/040/00479/AM19/ |
|
03.01.2019 |
|
|
|
|
**Decision:**A copy of application has been forwarded to DBT on 17.07.2019. Deferred for |
|
|
|
|
comments of |
|
|
|
DBT. |
|
|
|
|
|
|
80
| Case No.:794/15/82- |
|
Party Name:BDR |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
PHARMACEUTICALS |
|
ALC4/2019 |
|
Approved |
|
|
INTERNATIONAL PVT. LTD. |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310826132 |
|
|
| :01/82/050/02251/AM19/ |
|
:03/94/040/00836/AM19/ |
|
03.01.2019 |
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as 298 per details below or as applied by firm whichever is lower:
| Export Product |
Qty. |
Import item |
Qty. |
| Colistimethate Sodium for<br>Injection BP 1 Million<br>International Units per vial<br>10ml |
1 Number<br>(Vial up to<br>10ml) |
Colistimethate Sodium for Injection<br>BP |
96.65mg<br>/ vial |
| Case No.:796/15/82- |
|
Party |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
Name:D.K.BIOPHARMA |
|
ALC4/2019 |
|
Rejected |
|
|
PRIVATE LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310826158 |
|
|
| :01/82/050/02253/AM19/ |
|
:03/94/040/00842/AM19/ |
|
04.01.2019 |
|
|
299 Decision: The Committee considered the case as per agenda and it was observed that the import item – DETOX FOC-27 Fish Body Oil having ITC HS – 15042010 comes under Chapter 15 and as per para 4.11 (A) (i) of the FTP 2015-20 , all vegetable / edible oils classified under Chapter 15 of ITC (HS) are ineligible for import on self- declaration basis under para 4.07 of the FTP.
, the Committee decided to reject the case.
| 300 |
<br>Case No.:798/15/82-<br>ALC4/2018 |
Party Name:NEULAND<br>LABORATORIES LTD<br>RLA File<br>:09/24/040/00488/AM19/ |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02255/AM19/ |
|
Lic.No/Date:0910067032<br>04.01.2019 |
<br>Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 301 |
<br>Case No.:1072/15/82-<br>ALC4/2018 |
Party Name:MALLADI<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED<br>RLA File<br>:04/24/040/00218/AM19/ |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02529/AM19/ |
|
Lic.No/Date:0410165065<br>04.01.2019 |
<br>Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
81
| 302 |
Case No.:109/15/82-<br>ALC4/2018 |
Party Name:U SQUARE<br>LIFESCIENCE PRIVATE<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Lic.No/Date:0810144243<br>07.01.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/01566/AM19/ |
RLA File<br>:08/24/040/00329/AM19/ |
|
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
Case No.:202/15/82- Party Name:SUN Meet No/Date:7/82- Status: ALC4/2018 PHARMACEUTICAL ALC4/2019 Approved INDUSTRIES LTD. 06.09.2019 HQ File RLA File Lic.No/Date:0510409204 :01/82/050/01659/AM19/ :05/24/040/00554/AM19/ 07.01.2019 Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 8/82-ALC4/2018 , dated 20.09.2019, it was decided to ra tify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
|
Case No.:202/15/82-<br>ALC4/2018 |
Case No.:202/15/82-<br>ALC4/2018 |
Party Name:SUN<br>PHARMACEUTICAL<br>INDUSTRIES LTD. |
Party Name:SUN<br>PHARMACEUTICAL<br>INDUSTRIES LTD. |
Party Name:SUN<br>PHARMACEUTICAL<br>INDUSTRIES LTD. |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/01659/AM19/ |
|
RLA File<br>:05/24/040/00554/AM19/ |
|
|
Lic.No/Date:0510409204<br>07.01.2019 |
|
|
| 303 |
**Decision:**The Committee considered the case<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br> <br>, dated 20.09.2019, it was decided to ra<br>para 4.7 of HBP Vol. I as per details below or as |
|
|
|
as per agenda in the presence of Technical Experts and in<br>by<br>NC<br>in<br>its<br>Meeting<br>No.<br>8/82-ALC4/2018<br>tify the ad-hoc input output norms under<br>applied by firm whichever is lower: |
|
|
|
|
Export product |
Qty. |
|
Sl.<br>No. |
Import items |
|
Qty. |
|
|
Pentoxifylline |
1 kg |
|
1 |
Theobromine |
|
0.84 kg |
|
|
|
|
|
2 |
Chlorohexan-2-One / 6-Chloro-2-<br>Hexanone |
|
0.72 kg |
|
|
|
|
|
3 |
Dimethyl Formamide |
|
0.75 kg |
|
|
|
|
|
4 |
Pottasium Carbonate |
|
0.43 kg |
|
|
|
|
|
5 |
Methanol |
|
0.75 kg |
|
|
|
|
|
6 |
Acticarbone |
|
0.0117 kg |
|
|
RA concerned maytake further necessaryaction |
|
|
|
asper above decision of NC. |
|
|
|
Case No.:16/7/82- Party Name:GUJARAT Meet No/Date:7/82- Status: ALC4/2019 ORGANICS LIMITED ALC4/2019 Approved 06.09.2019 HQ File RLA File Lic.No/Date:0310826216 :01/82/050/00511/AM20/ :03/94/040/00860/AM19/ 07.01.2019 Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 13/82-ALC4/2018, dated 14.01.2019, it was 304 decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Qty. Sl. Import items Qty. No. PARA ANISIC ACID 1 kg 1 Para Hydroxy Benzoic Acid 1.12 kg RA may take appropriate action as per the decision of Norms Committee.
82
| Case No.:201/15/82- |
|
Party Name:RECKITT |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
BENCKISER (INDIA) |
|
ALC4/2019 |
|
Approved |
|
|
PRIVATE LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510409279 |
|
|
| :01/82/050/01658/AM19/ |
|
:05/24/040/00572/AM19/ |
|
09.01.2019 |
|
|
|
Case No.:201/15/82-<br>ALC4/2018 |
Case No.:201/15/82-<br>ALC4/2018 |
Party Name:RECKITT<br>BENCKISER (INDIA)<br>PRIVATE LIMITED |
Party Name:RECKITT<br>BENCKISER (INDIA)<br>PRIVATE LIMITED |
Party Name:RECKITT<br>BENCKISER (INDIA)<br>PRIVATE LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/01658/AM19/ |
|
RLA File<br>:05/24/040/00572/AM19/ |
|
|
Lic.No/Date:0510409279<br>09.01.2019 |
|
|
| 305 |
**Decision:**The Committee considered the case as<br>after deliberation, it was decided to ratify the adhoc<br>below or as applied by firm whichever is lower: |
|
|
|
|
|
|
|
|
Sl.<br>No. |
Export product |
Qty. |
Sl.<br>No. |
Import items |
|
Qty.<br>(mg /tablet) |
|
|
1 |
Disprin Cardiocare<br>(ASPIRIN BP 100MG)<br>ACETYL SALICYLIC<br>ACID 100mg Tablet<br>(ASPIRIN) |
1 Number |
1 |
SACCHARINBASE55Ox |
|
0.300 |
|
|
|
|
|
2 |
GLYCINE EP |
|
44.30 |
|
|
|
|
|
3 |
TALC EP |
|
1.7 |
|
|
2 |
DISPRIN,ZA,<br>EXTRA 4X12X16<br>(ASPIRIN PH.EUR<br>500MG) ACETYL<br>SALICYLIC ACID 500<br>mg Tablet (ASPIRIN) |
1 Number |
1 |
SACCHARIN BASE 55Ox |
|
7.50 |
|
|
|
|
|
3 |
TALC EP |
|
10.00 |
|
|
|
|
|
4 |
CITIRIC ACID ANHYDROUS<br>F4020 |
|
50.00 |
|
|
|
|
|
5 |
CALCIUM CARBONATE EP |
|
150.00 |
|
|
|
|
|
6 |
Aluminium Foil |
|
Relevant as<br>per packing<br>policy |
|
|
3 |
Disprin, ZA, Extra,<br>3x12x24 (ASPIRIN<br>PH.EUR 500MG)<br>ACETYL SALICYLIC<br>ACID 500 mg Tablet<br>(ASPIRIN) |
1 Number |
1 |
SACCHARINBASE55Ox |
|
7.50 |
|
|
|
|
|
3 |
TALC EP |
|
10.0 0 |
|
|
|
|
|
4 |
CITIRIC ACID ANHYDROUS<br>F4020 |
|
50.00 |
|
|
|
|
|
5 |
CALCIUM CARBONATE EP |
|
150.00 |
|
|
|
|
|
6 |
Aluminium Foil |
|
Relevant as<br>per packing<br>policy |
|
|
4 |
DISPRIN,ZA,EXTRA,<br>3X12X48 (ASPIRIN<br>PH.EUR 500MG)<br>ACETYL SALICYLIC<br>ACID 500 mg Tablet<br>(ASPIRIN) |
1 Number |
1 |
SACCHARIN BASE 55Ox |
|
7.50 |
|
|
|
|
|
3 |
TALC EP |
|
10.0 0 |
|
|
|
|
|
4 |
CITIRIC ACID ANHYDROUS<br>F4020 |
|
50.00 |
|
|
|
|
|
5 |
CALCIUM CARBONATE EP |
|
150.00 |
|
|
|
|
|
6 |
Aluminium Foil |
|
Relevant as<br>per packing<br>policy |
|
|
5 |
DISPRIN,ZA,EXTRA,<br>3X12X48 (ASPIRIN<br>PH.EUR 500MG)<br>ACETYL SALICYLIC<br>ACID 500 mg Tablet<br>(ASPIRIN) |
1 Number |
1 |
SACCHARIN BASE 55Ox |
|
7.50 |
|
|
|
|
|
3 |
TALCEP |
|
10.0 0 |
|
|
|
|
|
4 |
CITIRIC ACID ANHYDROUS<br>F4020 |
|
50.00 |
|
|
|
|
|
5 |
CALCIUMCARBONATE EP |
|
150.00 |
|
|
|
|
|
6 |
Aluminium Foil |
|
Relevant as<br>per packing<br>policy |
|
|
RA concerned maytake further |
|
necessaryaction asper above decision of NC. |
|
|
|
|
|
Decision: The Committee considered the case as per agenda in the presence of technical experts and after deliberation, it was decided to ratify the adhoc norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
| 306 |
Case No.:805/15/82-<br>ALC4/2018 |
Party Name:DEEPAK<br>NOVOCHEM<br>TECHNOLOGIES LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br> <br>Lic.No/Date:3110067278<br>09.01.2019<br> |
Status: Deferred |
|
HQ File<br>:01/82/050/02262/AM19/ |
RLA File<br>:31/83/040/00157/AM19/ |
|
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
83
|
Case No.:123/15/82- |
|
Party Name:REYAANSH |
|
Meet No/Date:7/82- |
|
Status: |
|
ALC4/2018 |
|
HEALTHCARE |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
06.09.2019 |
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310826282 |
|
Defer Date |
|
:01/82/050/01580/AM19/ |
|
:03/95/040/01019/AM19/ |
|
10.01.2019 |
|
|
307 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information:
(i) Number of pipettes in each carton
(ii) Drug Manufacturing license (DML) of the export product.
| Case No.:809/15/82- |
|
Party Name:ATUL LIMITED, |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
|
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0810144289 |
|
|
| :01/82/050/02266/AM19/ |
|
:08/24/040/00327/AM19/ |
|
10.01.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 308 applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| Cresyl Glycidyl Ether |
1 kg |
1 |
Epichlorohydrin |
0.626 kg |
|
|
2 |
Ortho Cresol |
0.725 kg |
|
Case No.:811/15/82- |
|
Party Name:ATUL LIMITED, |
|
Meet No/Date:7/82- |
|
Status: |
|
ALC4/2018 |
|
|
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
06.09.2019 |
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:0810144290 |
|
Defer Date |
|
:01/82/050/02268/AM19/ |
|
:08/24/040/00328/AM19/ |
|
10.01.2019 |
|
|
309 Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm:
(i) Percentage yield on molar basis at every stage.
(ii) Chemical reactions with molecular weights of all the chemicals involved in the reaction.
| 310 |
<br>Case No.:812/15/82-<br>ALC4/2018 |
Party Name:BALAJI<br>AMINES LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02269/AM19/ |
RLA File<br>:31/83/040/00158/AM19/ |
Lic.No/Date:3110067279<br>10.01.2019 |
<br>Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
84
| 311 |
<br>Case No.:815/15/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/02272/AM19/ |
Party Name:ELPPE<br>CHEMICALS PRIVATE<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Lic.No/Date:0310826358<br>14.01.2019 |
Status: Deferred |
|
|
RLA File<br>:03/94/040/00889/AM19/ |
|
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 312 |
Case No.:820/15/82-<br>ALC4/2018 |
Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br> <br>Defer Date |
|
<br>HQ File<br>:01/82/050/02277/AM19/ |
RLA File<br>:09/24/040/00508/AM19/ |
Lic.No/Date:0910067061<br>16.01.2019 |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
| Case No.:823/15/82- |
|
Party Name:BRAWN |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
LABORATORIES LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510409352 |
|
|
| :01/82/050/02280/AM19/ |
|
:05/23/040/00441/AM19/ |
|
16.01.2019 |
|
|
|
Case No.:823/15/82-<br>ALC4/2018 |
Party Name:BRAWN<br>LABORATORIES LTD<br>RLA File<br>:05/23/040/00441/AM19/ |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/02280/AM19/ |
|
Lic.No/Date:0510409352<br>16.01.2019 |
|
| 313 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 5/82-ALC4/2019dated02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>CEFADROXIL CAPSULES 500<br>MG<br>(HARD GELATIN CAPSULE<br>CONTAINING WHITE<br>CRYSTALLINE POWDER)<br>1 Number<br>1<br>CEFADROXIL<br>MONOHYDRATE<br>USP<br>(WHITE TO OFF<br>WHITE<br>CRYSTALLINE<br>POWDER)<br>535.244 mg<br>/ capsule<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 5/82-ALC4/2019dated02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
| 314 |
<br>Case No.:1026/15/82-<br>ALC4/2018 |
Party Name:ANLON<br>HEALTHCARE<br>PRIVATELIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br> <br>Defer Date |
|
<br>HQ File<br>:01/82/050/02483/AM19/ |
RLA File<br>:24/24/040/00049/AM19/ |
Lic.No/Date:2410042628<br>16.01.2019 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 315 |
<br>Case No.:829/15/82-<br>ALC4/2018 |
Party Name:AUROBINDO<br>PHARMA LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br> <br>Defer Date |
|
<br>HQ File<br>:01/82/050/02286/AM19/ |
RLA File<br>:09/24/040/00499/AM19/ |
Lic.No/Date:0910067071<br>18.01.2019 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
85
| 316 |
<br>Case No.:830/15/82-<br>ALC4/2018 |
Party Name:R CHEM<br>(SOMANAHALLI)<br>PVT.LTD, |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Lic.No/Date:0910067074<br>18.01.2019 |
Status:<br>Deferred<br> <br>Defer Date |
|
<br>HQ File<br>:01/82/050/02287/AM19/ |
RLA File<br>:09/24/040/00516/AM19/ |
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 317 |
<br>Case No.:837/15/82-<br>ALC4/2018 |
Party Name:DANOPHARM<br>CHEMICALS PRIVATE<br>LTD. |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status: Deferred |
|
<br>HQ File<br>:01/82/050/02294/AM19/ |
RLA File<br>:03/94/040/00886/AM19/ |
Lic.No/Date:0310826539<br>22.01.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:869/15/82- |
|
Party Name:ALKALI METALS |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
LTD., |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067104 |
|
|
| :01/82/050/02326/AM19/ |
|
:09/24/040/00495/AM19/ |
|
23.01.2019 |
|
|
|
Case No.:869/15/82-<br>ALC4/2018 |
Case No.:869/15/82-<br>ALC4/2018 |
Party Name:ALKALI METALS<br>LTD., |
Party Name:ALKALI METALS<br>LTD., |
Party Name:ALKALI METALS<br>LTD., |
Party Name:ALKALI METALS<br>LTD., |
<br>Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
<br>Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/02326/AM19/ |
|
RLA File<br>:09/24/040/00495/AM19/ |
|
|
|
Lic.No/Date:0910067104<br>23.01.2019 |
|
|
| 318 |
<br>**Decision:**The Committee considered case as per agenda and in the presence of the technical experts<br>and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per SION A-1914 or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>SODIUM<br>TERTIARY<br>BUTOXIDE<br>20% SOLUTION IN THF (SODIUM<br>TERT.BUTYLATE<br>SOL.20%<br>IN<br>TETRAHYDROFURAN<br>1 kg<br>1<br>SODIUM METAL<br>99% PURE MIN<br>0.0528 kg<br>2<br>TETRA HYDRO<br>FURAN<br>0.96 kg<br>3<br>TERTIARY<br>BUTANOL 99.9%<br>0.1696 kg<br>RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
|
SODIUM<br>TERTIARY<br>BUTOXIDE<br>20% SOLUTION IN THF (SODIUM<br>TERT.BUTYLATE<br>SOL.20%<br>IN<br>TETRAHYDROFURAN |
|
1 kg |
1 |
SODIUM METAL<br>99% PURE MIN |
|
0.0528 kg |
|
|
|
|
|
|
2 |
TETRA HYDRO<br>FURAN |
|
0.96 kg |
|
|
|
|
|
|
3 |
TERTIARY<br>BUTANOL 99.9% |
|
0.1696 kg |
|
|
|
|
|
|
|
|
|
|
|
| 319 |
<br>Case No.:842/15/82-<br>ALC4/2018 |
Party Name:S.M. HERBALS<br>PVT.LTD. |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02299/AM19/ |
RLA File<br>:05/24/040/00602/AM19/ |
Lic.No/Date:0510409465<br>24.01.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
86
| 320 |
Case No.:212/15/82-<br>ALC4/2018 |
Party Name:VENUS<br>REMEDIES LTD., |
Party Name:VENUS<br>REMEDIES LTD., |
Party Name:VENUS<br>REMEDIES LTD., |
Party Name:VENUS<br>REMEDIES LTD., |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approve d |
|
HQ File<br>:01/82/050/01669/AM19/ |
RLA File<br>:22/24/040/00079/AM19/ |
|
|
|
Lic.No/Date:2210016070<br>25.01.2019 |
|
|
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 14/82-ALC4/2018 dated 14.02.2019, it was decided to ratify norms under Para 4.7 of HBP v1<br>as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>MEROPENEM<br>500<br>MG<br>POWDER FOR SOLUTION<br>FOR<br>INJECTION<br>OR<br>INFUSION<br>EACH<br>VIAL<br>CONTAINS:<br>ACTIVE<br>PHARMACEUTICAL<br>INGREDIENTS<br>:<br>MEROPENEM TRIHYDRATE<br>EQV.<br>TO<br>MEROPENEM<br>ANHYDROUS...500<br>MG,<br>EXCIPIENTS: ANHYDROUS<br>SODIUM CARBONATE...104<br>MG,<br>EQUIVALENT<br>TO<br>45.1MG OF SODIUM<br>1 Number<br>1<br>MEROPENEM AND<br>SODIUM CARBONATE<br>(STERILE BULK)<br>0.690 gm /<br>500 mg vial<br>MEROPENEM<br>1.0<br>GM<br>POWDER FOR SOLUTION<br>FOR<br>INJECTION<br>OR<br>INFUSION<br>EACH<br>VIAL<br>CONTAINS:<br>ACTIVE<br>PHARMACEUTICAL<br>INGREDIENTS<br>:<br>MEROPENEM TRIHYDRATE<br>EQV.<br>TO<br>MEROPENEM<br>ANHYDROUS...1000<br>MG,<br>EXCIPIENTS: ANHYDROUS<br>SODIUM CARBONATE...208<br>MG, EQUIVALENT TO 90.2<br>MG OFSODIUM<br>1 Number<br>1<br>MEROPENEM AND<br>SODIUM CARBONATE<br>(STERILE BULK)<br>1.380 gm /<br>1 gm vial<br>RA concerned maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
|
|
<br>MEROPENEM<br>500<br>MG<br>POWDER FOR SOLUTION<br>FOR<br>INJECTION<br>OR<br>INFUSION<br>EACH<br>VIAL<br>CONTAINS:<br>ACTIVE<br>PHARMACEUTICAL<br>INGREDIENTS<br>:<br>MEROPENEM TRIHYDRATE<br>EQV.<br>TO<br>MEROPENEM<br>ANHYDROUS...500<br>MG,<br>EXCIPIENTS: ANHYDROUS<br>SODIUM CARBONATE...104<br>MG,<br>EQUIVALENT<br>TO<br>45.1MG OF SODIUM |
|
1 Number |
1 |
MEROPENEM AND<br>SODIUM CARBONATE<br>(STERILE BULK) |
|
|
|
MEROPENEM<br>1.0<br>GM<br>POWDER FOR SOLUTION<br>FOR<br>INJECTION<br>OR<br>INFUSION<br>EACH<br>VIAL<br>CONTAINS:<br>ACTIVE<br>PHARMACEUTICAL<br>INGREDIENTS<br>:<br>MEROPENEM TRIHYDRATE<br>EQV.<br>TO<br>MEROPENEM<br>ANHYDROUS...1000<br>MG,<br>EXCIPIENTS: ANHYDROUS<br>SODIUM CARBONATE...208<br>MG, EQUIVALENT TO 90.2<br>MG OFSODIUM |
|
1 Number |
1 |
MEROPENEM AND<br>SODIUM CARBONATE<br>(STERILE BULK) |
|
|
|
RA concerned maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
87
| Case No.:844/15/82- |
|
Party Name:KLJ |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
PLASTICIZERS LIMITED. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510409477 |
|
|
| :01/82/050/02301/AM19/ |
|
:05/23/040/00475/AM19/ |
|
25.01.2019 |
|
|
|
Case No.:844/15/82-<br>ALC4/2018 |
Case No.:844/15/82-<br>ALC4/2018 |
Party Name:KLJ<br>PLASTICIZERS LIMITED. |
Party Name:KLJ<br>PLASTICIZERS LIMITED. |
Party Name:KLJ<br>PLASTICIZERS LIMITED. |
Party Name:KLJ<br>PLASTICIZERS LIMITED. |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/02301/AM19/ |
|
RLA File<br>:05/23/040/00475/AM19/ |
|
|
|
Lic.No/Date:0510409477<br>25.01.2019 |
|
|
| 321 |
<br>**Decision:**The Committee considered case as per agenda and in the presence of the technical experts<br>and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per SION A-1291 or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>DI-BUTYL PHTHALATE (GRADE-M)<br>(DBP-M)<br>(PACKED IN 2554 NOS. OF HM-HDPE<br>DRUMS MADE OF HDPE GRANULES<br>(21,709.000 KGS. WITHOUT<br>WASTAGE)) (EACH DRUM SHALL<br>WEIGHT 8.5 KG AND STORAGE<br>CAPACITY 235.000 KGS.)<br>1 kg<br>1<br>PHTHALIC<br>ANHYDRIDE<br>0.56 kg<br>2<br>SABUTOL<br>0.56 kg<br>3<br>HDPE GRANULES<br>(TOTAL WEIGHT =<br>22,794.450 KGS.)<br>Relevant as per<br>packing policy<br>RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
|
DI-BUTYL PHTHALATE (GRADE-M)<br>(DBP-M)<br>(PACKED IN 2554 NOS. OF HM-HDPE<br>DRUMS MADE OF HDPE GRANULES<br>(21,709.000 KGS. WITHOUT<br>WASTAGE)) (EACH DRUM SHALL<br>WEIGHT 8.5 KG AND STORAGE<br>CAPACITY 235.000 KGS.) |
|
1 kg |
1 |
PHTHALIC<br>ANHYDRIDE |
|
0.56 kg |
|
|
|
|
|
|
2 |
SABUTOL |
|
0.56 kg |
|
|
|
|
|
|
3 |
HDPE GRANULES<br>(TOTAL WEIGHT =<br>22,794.450 KGS.) |
|
Relevant as per<br>packing policy |
|
|
|
|
|
|
|
|
|
|
|
| 322 |
Case No.:845/15/82-<br>ALC4/2018 |
Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02302/AM19/ |
RLA File<br>:03/94/040/00925/AM19/ |
Lic.No/Date:0310826640<br>25.01.2019 |
|
|
**Decision:**The Committee considered the case as per agenda<br>information from the firm:<br>(i) DrugManufacturingLicense(DML). |
|
and it was decided to call for following |
|
323
|
Case No.:847/15/82- |
|
Party Name:LIRICON |
|
Meet No/Date:7/82- |
|
Status: |
|
ALC4/2018 |
|
TRADING |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
06.09.2019 |
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310826653 |
|
Defer Date |
|
:01/82/050/02304/AM19/ |
|
:03/95/040/01055/AM19/ |
|
25.01.2019 |
|
|
Decision: The Committee considered the case as per agenda and it was observed that the information given in the description of export product is incorrect and also the import quantity is not matching with the export product. Hence, the norms could not be work out.
In view of above, the Committee decided to call the firm for Personal Hearing.
88
| Case No.:848/15/82- |
|
Party Name:VIVIMED LIFE |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
SCIENCES PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067112 |
|
Defer Date |
| :01/82/050/02305/AM19/ |
|
:09/24/040/00505/AM19/ |
|
28.01.2019 |
|
|
324 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information:
(i) Copy of Master Batch Formula duly authenticated by Quality Control Incharge for each export item showing the net weight of each input in the export items.
(ii) Drug Manufacturing license (DML) of the export product.
| 325 |
<br>Case No.:851/15/82-<br>ALC4/2018 |
Party Name:SI GROUP -<br>INDIA PRIVATE LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Lic.No/Date:0310826724<br>30.01.2019 |
Status:<br>Deferred<br> <br>Defer Date |
|
<br>HQ File<br>:01/82/050/02308/AM19/ |
RLA File<br>:03/95/040/01108/AM19/ |
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 326 |
<br>Case No.:853/15/82-<br>ALC4/2018 |
Party Name:ALPHAMED<br>FORMULATIONS P LTD. |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02310/AM19/ |
RLA File<br>:09/24/040/00511/AM19/ |
Lic.No/Date:0910067120<br>31.01.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 327 |
Case No.:855/15/82-<br>ALC4/2018 |
Party Name:SMS<br>LIFESCIENCES INDIA<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Lic.No/Date:0910067122<br>31.01.2019 |
Status:<br>Deferred<br> <br>Defer Date |
|
<br>HQ File<br>:01/82/050/02312/AM19/ |
RLA File<br>:09/24/040/00542/AM19/ |
|
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
| 328 |
Case No.:861/15/82-<br>ALC4/2018 |
Party Name:INNOVARE<br>LABS PRIVATE LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Lic.No/Date:0910067125<br>01.02.2019 |
Status: Deferred |
|
<br>HQ File<br>:01/82/050/02318/AM19/ |
RLA File<br>:09/24/040/00535/AM19/ |
|
Defer Date |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
89
|
|
Case No.:863/15/82-<br>Party Name:JAYANT AGRO |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018<br>ORGANICS LTD., |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
06.09.2019 |
|
|
|
|
HQ File<br>RLA File |
|
Lic.No/Date:0310826798 |
|
Defer Date |
| 329 |
|
:01/82/050/02320/AM19/<br>:03/94/040/00948/AM19/<br>**Decision:**The Committee considered the case as per agenda |
04.02.2019<br>and it was decided to call for following |
|
|
|
|
|
information from the firm: |
|
|
|
|
|
|
(i) Percentage yield on molar basis at every stage. |
|
|
|
|
|
|
(ii) Chemical reactions with molecular weights of all the chemicals involved in the reaction. |
|
|
|
|
|
|
Case No.:864/15/82- |
|
Party Name:J.B. CHEMICALS |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
& PHARMACEUTICALS |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
06.09.2019 |
|
|
| 330 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310826799 |
|
Defer Date |
|
|
:01/82/050/02321/AM19/ |
|
:03/94/040/00944/AM19/ |
|
04.02.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:870/15/82- |
|
Party Name:SHREE BANKEY |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
BEHARI LAL FLAVORS |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:0510409585 |
|
Defer Date |
| 331 |
|
:01/82/050/02327/AM19/ |
|
:05/24/040/00623/AM19/ |
|
05.02.2019 |
|
|
|
|
**Decision:**The Committee considered the case as per agenda and |
|
|
|
it was decided to call for following |
|
|
|
|
information from the firm: |
|
|
|
|
|
|
|
|
(i)<br>Complete technical details asper Appendix 4E. |
|
|
|
|
|
|
|
|
Case No.:873/15/82- |
|
Party Name:CADILA |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
HEALTHCARE LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 332 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0810144496 |
|
Defer Date |
|
|
:01/82/050/02330/AM19/ |
|
:08/24/040/00379/AM19/ |
|
05.02.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:874/15/82- |
|
Party Name:CADILA |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
HEALTHCARE LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 333 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0810144497 |
|
Defer Date |
|
|
:01/82/050/02331/AM19/ |
|
:08/24/040/00372/AM19/ |
|
05.02.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
90
| Case No.:875/15/82- |
|
Party Name:CADILA |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
HEALTHCARE LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0810144498 |
|
|
| :01/82/050/02332/AM19/ |
|
:08/24/040/00381/AM19/ |
|
05.02.2019 |
|
|
|
Case No.:875/15/82-<br>ALC4/2018 |
Case No.:875/15/82-<br>ALC4/2018 |
Case No.:875/15/82-<br>ALC4/2018 |
Case No.:875/15/82-<br>ALC4/2018 |
Case No.:875/15/82-<br>ALC4/2018 |
Case No.:875/15/82-<br>ALC4/2018 |
Case No.:875/15/82-<br>ALC4/2018 |
Party Name:CADILA<br>HEALTHCARE LTD |
Party Name:CADILA<br>HEALTHCARE LTD |
Party Name:CADILA<br>HEALTHCARE LTD |
Party Name:CADILA<br>HEALTHCARE LTD |
Party Name:CADILA<br>HEALTHCARE LTD |
Meet No/Date:7/82-<br>ALC4/2019 |
Meet No/Date:7/82-<br>ALC4/2019 |
Meet No/Date:7/82-<br>ALC4/2019 |
Status:<br>Approved |
Status:<br>Approved |
|
|
|
|
|
|
|
|
|
|
|
|
|
<br>06.09.2019 |
|
|
|
|
|
HQ File<br>:01/82/050/02332/AM19/ |
|
|
|
|
|
|
RLA File<br>:08/24/040/00381/AM19/ |
|
|
|
|
Lic.No/Date:0810144498<br>05.02.2019 |
|
|
|
|
|
**Decision:**The Comm<br>in<br>the<br>light<br>of<br>earli |
|
|
|
ittee considered the case as per agenda<br>er<br>decision<br>taken<br>by<br>NC<br>in |
|
|
|
|
|
|
|
in the presence of Technica<br>its<br>Meeting<br>No<br>3/8 |
|
|
l Experts and<br>2-ALC4/2019 |
|
|
<br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br>.<br> <br>, dated 05.07.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>per details below or as applied by firm whichever is lower: |
|
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| 334 |
|
S.<br>No. |
|
Export Product |
|
|
|
|
|
|
|
|
|
|
Qty |
. |
|
|
|
1 |
|
LEFLUNOMIDE<br>(ACTIVE INGREDIE |
|
|
|
TABLETS<br>USP<br>NT:LEFLUNOMIDEUSP -NETW |
|
|
|
|
10<br>MG<br>T. 33.599KGS) |
|
1 N |
umber |
|
|
|
2 |
|
LEFLUNOMIDE<br>(ACTIVE INGREDIE |
|
|
|
TABLETS<br>USP<br>NT : LEFLUNOMIDE USP-NET W |
|
|
|
|
20<br>MG<br>T. 139.997 KGS) |
|
1 N |
umber |
|
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S.NO. |
|
|
Import Items |
|
|
|
|
|
|
For export of 1 No.Tablet<br>(Quantity in mg / tablet) |
|
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10 mg / tablet |
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20 mg / tabl |
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et |
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1 |
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LEFLUNOMIDE |
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SP |
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102 |
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2040 |
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. |
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2 |
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LACTOSE MONO<br>(PHARMATOSE 2 |
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HYDRAT<br>00M) |
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E NF/PH |
E |
9275 |
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8275 |
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3 |
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CORN STARCH N |
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F(MAIZ |
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STAR |
H B |
3000 |
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3000 |
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) |
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<br>RA may |
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take appropriate acti |
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on asper t |
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he decisi |
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| 335 |
Case No.:876/15/82-<br>ALC4/2018 |
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Party Na<br>LABOR |
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me:MOR<br> |
EPEN<br> |
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Meet No/Date:7/82-<br> |
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Stat<br> |
us:<br> |
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ATORIE |
S LTD., |
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ALC4/2019<br> |
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Def |
erred |
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06.09.2019 |
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HQ File<br>:01/82/050/02333/AM19/ |
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RLA Fil<br>:05/24/0 |
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e |
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Lic.No/Date:0510409596 |
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<br>Def |
er Date |
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40/00634 |
/AM19/ |
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05.02.2019 |
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**Decision:**Deferred for comments of |
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TE. |
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Case No.:876/15/82- |
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Party Name:MOREPEN |
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Meet No/Date:7/82- |
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Status: |
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ALC4/2018 |
|
LABORATORIES LTD., |
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ALC4/2019 |
|
Deferred |
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06.09.2019 |
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| 335 |
|
HQ File |
|
RLA File |
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Lic.No/Date:0510409596 |
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Defer Date |
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:01/82/050/02333/AM19/ |
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:05/24/040/00634/AM19/ |
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05.02.2019 |
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**Decision:**Deferred for comments of TE. |
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| 336 |
Case No.:1027/15/82-<br>ALC4/2018 |
Party Name:ANLON<br>HEALTHCARE<br>PRIVATELIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/02484/AM19/ |
RLA File<br>:24/24/040/00053/AM19/ |
Lic.No/Date:2410042653<br>05.02.2019 |
<br>Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
91
|
Case No.:880/15/82- |
|
Party Name:DEEPAK |
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Meet No/Date:7/82- |
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Status: |
|
ALC4/2018 |
|
NOVOCHEM |
|
ALC4/2019 |
|
Deferred |
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TECHNOLOGIES LTD |
|
06.09.2019 |
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HQ File |
|
RLA File |
|
Lic.No/Date:3110067309 |
|
Defer Date |
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:01/82/050/02337/AM19/ |
|
:31/83/040/00162/AM19/ |
|
06.02.2019 |
|
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337 Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm:
(i) Exact chemical name of the export product.
(ii) A copy of full set of 4.07 application
| 338 |
Case No.:881/15/82-<br>ALC4/2018 |
Party Name:SHILPA<br>MEDICARE LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02338/AM19/ |
RLA File<br>:07/24/040/00263/AM19/ |
Lic.No/Date:0710114519<br>07.02.2019 |
<br>Defer Date |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Bangalore. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Bangalore.
| 339 |
Case No.:883/15/82-<br>ALC4/2018 |
Party Name:MAHESHRAJ<br>CHEMICALS PVT.LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02340/AM19/ |
RLA File<br>:08/24/040/00374/AM19/ |
Lic.No/Date:0810144562<br>08.02.2019 |
<br>Defer Date |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Ahmedabad. |
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Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Ahmedabad.
| 340 |
<br>Case No.:885/15/82-<br>ALC4/2018 |
Party Name:ORTIN<br>LABORATORIES LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02342/AM19/ |
RLA File<br>:09/24/040/00538/AM19/ |
Lic.No/Date:0910067148<br>08.02.2019 |
<br>Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 341 |
<br>Case No.:887/15/82-<br>ALC4/2018 |
Party Name:ENAL DRUGS<br>PVT LTD., |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02344/AM19/ |
RLA File<br>:09/24/040/00543/AM19/ |
Lic.No/Date:0910067153<br>08.02.2019 |
<br>Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
92
| 342 |
Case No.:888/15/82-<br>ALC4/2018 |
Party Name:ASTRAL<br>STERITECH PVT. LTD. |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02345/AM19/ |
RLA File<br>:34/24/040/00333/AM19/ |
Lic.No/Date:3410044867<br>08.02.2019 |
<br>Defer Date |
|
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to call for following information:<br>(i) DrugManufacturinglicense(DML)of the exportproduct. |
|
|
|
| Case No.:891/15/82- |
|
Party Name:GELTEC |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
PRIVATE LIMITED |
|
ALC4/2019 |
|
Deferred |
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|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310826970 |
|
Defer Date |
| :01/82/050/02348/AM19/ |
|
:03/94/040/00970/AM19/ |
|
11.02.2019 |
|
|
343 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information:
(ii) Copy of Master Batch Formula duly authenticated by Quality Control Incharge for each export item showing the net weight of each input in the export items. (iii) Drug Manufacturing license (DML) of the export product.
93
| Case No.:892/15/82- |
|
Party Name:J.B. CHEMICALS |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
& PHARMACEUTICALS |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310826971 |
|
|
| :01/82/050/02349/AM19/ |
|
:03/94/040/00978/AM19/ |
|
11.02.2019 |
|
|
|
Case No.:892/15/82-<br>ALC4/2018 |
Case No.:892/15/82-<br>ALC4/2018 |
Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED |
Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED |
Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/02349/AM19/ |
|
RLA File<br>:03/94/040/00978/AM19/ |
|
|
Lic.No/Date:0310826971<br>11.02.2019 |
|
|
| 344 |
**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as<br>per details below or as applied by firm whichever is lower: |
|
|
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|
|
Sl.<br>No. |
Export Product |
|
Qty. |
Sl.<br>No. |
|
Import Item |
Qty |
|
1 |
Benzydamine<br>Hydrochloride<br>And<br>Cetylpyridinium<br>Chloride<br>Anti-<br>Inflammatory<br>And<br>Antiseptic<br>Lozenges<br>Sugar Free and all other flavours.<br>Each<br>lozenge<br>contains<br>(i)<br>Benzydamine Hydrochloride-3mg (ii)<br>Cetylpyridinium Chloride- 1.33mg<br>(iii) Isomalt ST-M - 2586mg. Net<br>content (i) 43.796 Kgs (ii) 19.416<br>Kgs (iii) 37751.835 Kgs |
|
1 Number |
1 |
|
Benzydamine<br>Hydrochloride |
3.06 mg |
|
|
|
|
|
2 |
|
Cetylpyridinium<br>Chloride |
1.33 mg |
|
|
|
|
|
3 |
|
Isomalt ST-M |
2586mg |
|
2 |
Benzydamine Hydrochloride, 2,4-<br>Dichlorobenzyl<br>Alcohol<br>And<br>Lidocaine<br>Hydrochloride<br>Anaesthetic,<br>Anti-Inflammatory,<br>Anti-Bacterial Lozenges Sugar Free.<br>Each<br>lozenge<br>contains<br>(i)<br>Benzydamine Hydrochloride - 3mg<br>(ii) Isomalt ST-M- 2586mg. Net<br>content<br>(i)<br>21.898<br>Kgs.<br>(ii)<br>18875.897 Kgs. |
|
1 Number |
4 |
|
Benzydamine<br>Hydrochloride |
3.06 mg |
|
|
|
|
|
5 |
|
Isomalt ST-M |
2586 mg |
|
3 |
Benzydamine Hydrochloride Anti-<br>Inflammatory Lozenges Sugar Free.<br>Each<br>lozenge<br>contains<br>(i) Benzydamine Hydrochloride- 3mg<br>(ii) Isomalt ST-M - 2595mg. Net<br>content (i) 14.234 Kgs. (ii) 12312.05<br>Kgs. |
|
1 Number |
6 |
|
Benzydamine<br>Hydrochloride |
3.06 mg |
|
|
|
|
|
7 |
|
Isomalt ST-M |
2595 mg |
|
4 |
Cetylpyridinium<br>Chloride<br>And<br>Bromhexine<br>Hydrochloride<br>Antiseptic Lozenges Sugar Free and<br>all<br>other<br>flavours.<br>Each<br>lozenge<br>contains<br>(i)<br>Cetylpyridinium Chloride - 1.33mg<br>(ii) Isomalt ST-M - 2576mg. Net<br>content (i) 1.873 Kgs. (ii) 3628.141<br>Kgs. |
|
1 Number |
8 |
|
Cetylpyridinium<br>Chloride |
1.33 mg |
|
|
|
|
|
9 |
|
Isomalt ST-M |
2576 mg |
|
5 |
Cetylpyridinium<br>Chloride<br>And<br>Benzydamine<br>Hydrochloride<br>Antiseptic Lozenges Suger Free.<br>Each<br>lozenge<br>contains<br>(i)<br>Cetylpyridinium Chloride- 1mg (ii)<br>Isomalt ST-M - 2595mg. Net content<br>(i) 1.408 Kgs (ii) 3654.923 Kgs. |
|
1 Number |
10 |
|
Cetylpyridinium<br>Chloride |
1 mg |
|
|
|
|
|
11 |
|
Isomalt ST-M |
2595 mg |
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
|
94
|
|
Case No.:894/15/82- |
|
Party Name:DEEPAK |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
PHENOLICS LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 345 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:3410044883 |
|
Defer Date |
|
|
:01/82/050/02351/AM19/ |
|
:34/24/040/00328/AM19/ |
|
12.02.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:899/15/82- |
|
Party Name:ATUL LIMITED, |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
|
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:0810144581 |
|
Defer Date |
| 346 |
|
:01/82/050/02356/AM19/<br>:08/24/040/00371/AM19/<br>**Decision:**The Committee considered the case as per agenda |
|
|
12.02.2019<br>and it was decided to call for following |
|
|
|
|
|
information from the firm: |
|
|
|
|
|
|
|
|
(i) Complete 4E with all technical details i.e chemistry, molecular weight, stoichiometric |
|
|
|
|
|
reaction and |
|
|
% ofyield on molar basis at everystage. |
|
|
|
|
|
|
|
|
Case No.:896/15/82- |
|
Party Name:AUROBINDO |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
PHARMA LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 347 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910067168 |
|
Defer Date |
|
|
:01/82/050/02353/AM19/ |
|
:09/24/040/00555/AM19/ |
|
13.02.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
| Case No.:897/15/82- |
|
Party Name:SATYADEVA |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
PHARMACEUTICALS PVT |
|
ALC4/2019 |
|
Approved |
|
|
LTD |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067170 |
|
|
| :01/82/050/02354/AM19/ |
|
:09/24/040/00551/AM19/ |
|
13.02.2019 |
|
|
|
Case No.:897/15/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/02354/AM19/ |
Case No.:897/15/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/02354/AM19/ |
Party Name:SATYADEVA<br>PHARMACEUTICALS PVT<br>LTD |
Party Name:SATYADEVA<br>PHARMACEUTICALS PVT<br>LTD |
Party Name:SATYADEVA<br>PHARMACEUTICALS PVT<br>LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Lic.No/Date:0910067170<br>13.02.2019 |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Lic.No/Date:0910067170<br>13.02.2019 |
Status:<br>Approved |
|
|
|
RLA File<br>:09/24/040/00551/AM19/ |
|
|
|
|
|
| 348 |
<br>**Decision:**The Representative of the firm appeared for PH before Norms Committee and explained its<br>case. The Committee after deliberation decided to ratify norms under Para 4.7 of HBP v1 as per details<br>given below or as applied by the firm, whichever is less:<br>Export Product<br>Qty<br>Sl.<br>No.<br>Import Items<br>Qty<br>(2S,3S,5S)-2-Amino-3-<br>Hydroxy-5-(1-Tetra hydro<br>pyramid-2-only)-3-Methyl<br>butanoyl)<br>Amino-1,6-diphenyl Hexane-s-<br>pyro glutamate(THP)<br>1 kg<br>1<br>DAH-II<br>1.13 kg<br>2<br>1,2 DIMETHOXYETHANE<br>6.74 kg<br>3<br>SODIUM BOROHYDRIDE<br>0.406 kg<br>4<br>METHANE SULFONIC ACID<br>(OR)METHANESULPHONIC ACID<br>1.57 kg<br>5<br>ISOPROPYL ALCOHOL<br>1.27 kg<br>6<br>Triethanolamine(99%)<br>1.167 kg<br>7<br>N.N-DIMETHYL ACETAMIDE (OR)<br>DIMETHYL ACETAMIDE<br>1.60 kg<br>8<br>L-VALINE<br>0.630 kg<br>9<br>MCF(Methyl chloroformate)<br>1.00 kg<br>10<br>MDC(Methylene Dichloride)<br>3.25 kg<br>11<br>ACRYLONITRILE<br>0.30 kg<br>12<br>METHANOL<br>3.30 kg |
|
|
|
|
|
|
|
|
Export Product |
Qty |
|
Sl.<br>No. |
Import Items |
|
Qty |
|
|
<br>(2S,3S,5S)-2-Amino-3-<br>Hydroxy-5-(1-Tetra hydro<br>pyramid-2-only)-3-Methyl<br>butanoyl)<br>Amino-1,6-diphenyl Hexane-s-<br>pyro glutamate(THP) |
1 kg |
|
1 |
DAH-II |
|
1.13 kg |
|
|
|
|
|
2 |
1,2 DIMETHOXYETHANE |
|
6.74 kg |
|
|
|
|
|
3 |
SODIUM BOROHYDRIDE |
|
0.406 kg |
|
|
|
|
|
4 |
METHANE SULFONIC ACID<br>(OR)METHANESULPHONIC ACID |
|
1.57 kg |
|
|
|
|
|
5 |
ISOPROPYL ALCOHOL |
|
1.27 kg |
|
|
|
|
|
6 |
Triethanolamine(99%) |
|
1.167 kg |
|
|
|
|
|
7 |
N.N-DIMETHYL ACETAMIDE (OR)<br>DIMETHYL ACETAMIDE |
|
1.60 kg |
|
|
|
|
|
8 |
L-VALINE |
|
0.630 kg |
|
|
|
|
|
9 |
MCF(Methyl chloroformate) |
|
1.00 kg |
|
|
|
|
|
10 |
MDC(Methylene Dichloride) |
|
3.25 kg |
|
|
|
|
|
11 |
ACRYLONITRILE |
|
0.30 kg |
|
|
|
|
|
12 |
METHANOL |
|
3.30 kg |
|
Decision: The Representative of the firm appeared for PH before Norms Committee and explained its case. The Committee after deliberation decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
95
|
13 |
METHYL TETR-BUTYL ETHER |
2.45 kg |
|
|
(OR)TERTIARY BUTYL METHYL |
|
|
|
ETHER |
|
|
14 |
N,N-CARBONYL DIMIDAZOLE |
0.443 kg |
|
15 |
AMMONIUMFORMATE |
0.500 kg |
|
16 |
DIMETHYL FORMAMIDE |
3.95 kg |
|
17 |
L-PYROGLUTAMIC ACID |
0.295 kg |
|
18 |
AMMONIUM CHLORIDE |
2.00 kg |
|
19 |
PALLADIUM SPONGE(99.95% MIN) |
0.001 kg |
| Case No.:898/15/82- |
|
Party Name:DR. REDDYS |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
LABORATORIES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067171 |
|
|
| :01/82/050/02355/AM19/ |
|
:09/24/040/00558/AM19/ |
|
13.02.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: 349
| Export product |
|
|
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
No. |
|
|
| (S)-N-(1-carboxy-2-methyl-prop-1-yl)-N- |
|
|
1 kg |
1 |
N-[(2-Cyanobiphenyl- |
0.785 kg |
| pentanoyl-N-[2-(1H-tetrazol-5-yl) |
|
|
|
|
4-Methyl)] -(L)-Valine |
|
| biphenyl-4-yl-methyl] |
amine |
barium |
|
|
Methyl ester HCl |
|
| (VLS1) |
|
|
|
2 |
Methylene Chloride |
2.47 kg |
RA may take appropriate action as per the decision of Norms Committee
| Case No.:901/15/82- |
|
Party Name:KUMAR |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
ORGANIC PRODUCTS |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED, |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710114543 |
|
|
| :01/82/050/02358/AM19/ |
|
:07/24/040/00244/AM19/ |
|
13.02.2019 |
|
|
Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as 350 per details below or as applied by firm whichever is lower:
| Qty. |
Sl.<br>No. |
Import items |
Qty. |
| 1 kg |
1 |
2, CHLOROPYRIDINE,<br>ASSAY 85% |
0.984 kg |
96
|
|
Case No.:902/15/82- |
|
Party Name:INNOVARE |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
LABS PRIVATE LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 351 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910067173 |
|
Defer Date |
|
|
:01/82/050/02359/AM19/ |
|
:09/24/040/00549/AM19/ |
|
14.02.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:903/15/82- |
|
Party Name:MATRIX FINE |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
SCIENCES PVT.LTD., |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 352 |
|
HQ File<br>:01/82/050/02360/AM19/ |
|
RLA File<br>:03/95/040/01113/AM19/ |
|
Lic.No/Date:0310827030<br>14.02.2019 |
|
Defer Date |
|
|
**Decision:**The Committee |
noted that the 4.07 application of subject Advance Authorization is not |
|
|
|
|
|
|
|
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization |
|
|
|
|
|
|
|
|
from RLA,Mumbai. . |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai. .
|
|
Case No.:905/15/82- |
|
Party Name:JODAS EXPOIM |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
PVT.LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 353 |
|
HQ File<br>:01/82/050/02362/AM19/ |
|
RLA File<br>:05/23/040/00508/AM19/ |
|
Lic.No/Date:0510409675<br>15.02.2019 |
|
Defer Date |
|
|
**Decision:**The Committee |
noted that the 4.07 application of subject Advance Authorization is not |
|
|
|
|
|
|
|
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization |
|
|
|
|
|
|
|
|
from CLA,New Delhi. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.
|
|
Case No.:906/15/82- |
|
Party Name:JODAS EXPOIM |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
PVT.LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 354 |
|
HQ File<br>:01/82/050/02363/AM19/ |
|
RLA File<br>:05/23/040/00507/AM19/ |
|
Lic.No/Date:0510409676<br>15.02.2019 |
|
Defer Date |
|
|
**Decision:**The Committee |
noted that the 4.07 application of subject Advance Authorization is not |
|
|
|
|
|
|
|
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization |
|
|
|
|
|
|
|
|
from CLA,New Delhi. |
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.
|
|
Case No.:907/15/82- |
|
Party Name:AURORE LIFE |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
SCIENCES PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
06.09.2019 |
|
|
| 355 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910067181 |
|
Defer Date |
|
|
:01/82/050/02364/AM19/ |
|
:09/24/040/00515/AM19/ |
|
15.02.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
97
| Case No.:911/15/82- |
|
Party Name:YASHO |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310827118 |
|
|
| :01/82/050/02368/AM19/ |
|
:03/95/040/01195/AM19/ |
|
19.02.2019 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 356 applied by firm whichever is lower:
|
Export product |
|
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
No. |
|
|
|
COPPER |
DIBUTYL |
1 kg |
1 |
DI-N- |
0.600 kg |
|
DITHIOCARBAMATE(CDBC) |
|
|
|
BUTYLAMINE(DIBUTYLAMINE) |
|
|
|
|
|
2 |
CARBON DISULPHIDE |
0.360 kg |
|
|
|
|
3 |
COPPER SULPHATE |
0.443 kg |
| RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
|
|
|
Case No.:916/15/82- |
|
Party Name:OPTIMUS |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
DRUGS PRIVATE LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 357 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910067192 |
|
Defer Date |
|
|
:01/82/050/02373/AM19/ |
|
:09/24/040/00569/AM19/ |
|
20.02.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:919/15/82- |
|
Party Name:ORTIN |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
LABORATORIES LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 358 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910067198 |
|
Defer Date |
|
|
:01/82/050/02376/AM19/ |
|
:09/24/040/00573/AM19/ |
|
21.02.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:922/15/82- |
|
Party Name:GLOBE |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
TROTTERS PVT LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 359 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310827201 |
|
Defer Date |
|
|
:01/82/050/02379/AM19/ |
|
:03/94/040/01015/AM19/ |
|
21.02.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
98
|
|
Case No.:924/15/82- |
Party Name:INDO AMINES |
|
Meet No/Date:7/82- |
|
|
Status: |
|
|
ALC4/2018 |
LIMITED |
|
ALC4/2019 |
|
|
Deferred |
|
|
|
|
|
06.09.2019 |
|
|
|
|
|
HQ File |
RLA File |
|
Lic.No/Date:0310827206 |
|
|
Defer Date |
| 360 |
|
:01/82/050/02381/AM19/<br>:03/94/040/00984/AM19/<br>**Decision:**The Committee considered the case as per agenda |
|
21.02.2019<br>and it was decided to call |
|
for following |
|
|
|
|
information from the firm: |
|
|
|
|
|
|
|
|
(i) Complete 4E alongwith all technical details i.e chemistry, molecular weight, |
|
|
|
stoichiometric |
|
|
|
|
reaction and % ofyield on molar basis at everystage. |
|
|
|
|
|
|
|
|
Case No.:927/15/82- |
|
Party Name:SUVEN LIFE |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
SCIENCES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 361 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910067211 |
|
Defer Date |
|
|
:01/82/050/02384/AM19/ |
|
:09/24/040/00580/AM19/ |
|
22.02.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:929/15/82- |
|
Party Name:THINQ |
|
|
Meet No/Date:7/82- |
|
Status: Deferred |
|
|
ALC4/2018 |
|
PHARMA-CRO LIMITED |
|
|
ALC4/2019 |
|
|
|
|
|
|
|
|
|
06.09.2019 |
|
|
| 362 |
|
HQ File<br>:01/82/050/02386/AM19/ |
|
RLA File<br>:03/95/040/01186/AM19/ |
|
|
Lic.No/Date:0310827227<br>22.02.2019 |
|
Defer Date |
|
|
**Decision:**The Committee |
|
noted that the 4.07 application of subject Advance Authorization is not |
|
|
|
|
|
|
|
available. Hence, it was decided to call for a copy of 4.07 |
|
|
application of the subject advance authorization |
|
|
|
|
|
|
from RLA,Mumbai. |
|
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
|
|
Case No.:931/15/82- |
|
Party Name:MEHK |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
CHEMICALS PVT. LTD. |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310827242 |
|
Defer Date |
| 363 |
|
:01/82/050/02388/AM19/<br>:03/95/040/01227/AM19/<br>**Decision:**The Committee considered the case as per agenda |
|
|
22.02.2019<br>and it was decided to call for following |
|
|
|
|
|
information from the firm: |
|
|
|
|
|
|
|
|
(i) Complete 4E with all technical details i.e chemistry, molecular weight, stoichiometric |
|
|
|
|
|
reaction and |
|
|
% ofyield on molar basis at everystage. |
|
|
|
|
|
|
| 364 |
Case No.:932/15/82-<br>ALC4/2018 |
Party Name:MEHK<br>CHEMICALS PVT. LTD.<br>RLA File<br>:03/95/040/01209/AM19/ |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02389/AM19/ |
|
Lic.No/Date:0310827243<br>22.02.2019 |
Defer Date |
|
<br>**Decision:**The Committee considered the case as per agenda and it was decided to call for following<br>information from the firm:<br>(i) Complete 4E with all technical details i.e chemistry, molecular weight, stoichiometric reaction and<br>% ofyield on molar basis at everystage. |
|
|
|
99
|
|
Case No.:934/15/82- |
|
Party Name:ASTRAL |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
STERITECH PVT. LTD. |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 365 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:3410044929 |
|
Defer Date |
|
|
:01/82/050/02391/AM19/ |
|
:34/24/040/00356/AM19/ |
|
22.02.2019 |
|
|
|
|
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide e-mail |
|
|
|
|
|
|
|
|
dated 02.08.2019 has furnished |
|
its reply. Deferred for comments of TE. |
|
|
|
|
|
|
Case No.:935/15/82- |
|
Party Name:ASTRAL |
|
Meet No/Date:7/82- |
|
|
Status: Deferred |
|
|
ALC4/2018 |
|
STERITECH PVT. LTD. |
|
ALC4/2019 |
|
|
|
|
|
|
|
|
|
06.09.2019 |
|
|
|
| 366 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:3410044930 |
|
|
Defer Date |
|
|
:01/82/050/02392/AM19/ |
|
:34/24/040/00355/AM19/ |
|
22.02.2019 |
|
|
|
|
|
**Decision:**The Committee |
considered the case as per agenda and it was noted that |
|
|
|
the firm vide e-mail |
|
|
|
|
dated 02.08.2019 has furnished its reply. Deferred for comments of TE. |
|
|
|
|
|
|
|
|
|
Case No.:936/15/82- |
|
Party Name:VISION DRUGS |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
PVT LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 367 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910067217 |
|
Defer Date |
|
|
:01/82/050/02393/AM19/ |
|
:09/24/040/00575/AM19/ |
|
25.02.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:941/15/82- |
|
Party Name:AMANTA |
|
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
HEALTHCARE LIMITED |
|
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
|
06.09.2019 |
|
|
| 368 |
|
HQ File<br>:01/82/050/02398/AM19/ |
|
RLA File<br>:08/24/040/00405/AM19/ |
|
|
Lic.No/Date:0810144674<br>25.02.2019 |
|
Defer Date |
|
|
**Decision:**The Committee |
noted that the 4.07 application of subject Advance Authorization is not |
|
|
|
|
|
|
|
|
available. Hence, it was decided to call for a copy of 4.07 |
|
|
application of the subject advance authorization |
|
|
|
|
|
|
from RLA,Ahmedabad. |
|
|
|
|
|
|
|
Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Ahmedabad.
|
|
Case No.:1033/15/82- |
|
Party Name:SRIAM LABS |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
PRIVATE LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 369 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910067219 |
|
Defer Date |
|
|
:01/82/050/02490/AM19/ |
|
:09/24/040/00591/AM19/ |
|
26.02.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:1051/15/82- |
|
Party Name:YASHO |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 370 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310827302 |
|
Defer Date |
|
|
:01/82/050/02508/AM19/ |
|
:03/95/040/01264/AM19/ |
|
26.02.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
100
| 371 |
<br>Case No.:1038/15/82-<br>ALC4/2018 |
Party Name:GLAND<br>PHARMA LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02495/AM19/ |
RLA File<br>:09/24/040/00530/AM19/ |
Lic.No/Date:0910067224<br>27.02.2019 |
<br>Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 372 |
<br>Case No.:1039/15/82-<br>ALC4/2018 |
Party Name:GLAND<br>PHARMA LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02496/AM19/ |
RLA File<br>:09/24/040/00491/AM19/ |
Lic.No/Date:0910067225<br>27.02.2019 |
Defer Date |
|
**Decision:**Deferred for comments of Te. |
|
|
|
| Case No.:1041/15/82- |
|
Party Name:WEXFORD |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
LABORATORIES P LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710114597 |
|
Defer Date |
| :01/82/050/02498/AM19/ |
|
:07/24/040/00276/AM19/ |
|
27.02.2019 |
|
|
373 Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm:
(i) Complete 4E with all technical details i.e chemistry, molecular weight, stoichiometric reaction and % of yield on molar basis at every stage. (ii) Drug Manufacturing License (DML).
101
|
|
Case No.:1044/15/82-<br>Party Name:CADILA |
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Meet No/Date:7/82- |
Meet No/Date:7/82- |
|
Status: |
|
|
|
|
ALC4/2018<br>HEALTHCARE LTD |
|
|
|
ALC4/2019 |
|
|
Approved |
|
|
|
|
|
|
|
|
06.09.2019 |
|
|
|
|
|
|
|
HQ File<br>RLA File |
|
|
|
Lic.No/Date:0810144716 |
|
|
|
|
|
|
|
:01/82/050/02501/AM19/<br>:08/24/040/00412/AM19/ |
|
|
|
28.02.2019 |
|
|
|
|
|
|
|
**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and |
|
|
|
|
|
|
|
|
|
|
|
in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by |
NC |
in |
|
its<br>Meeting<br>No. |
|
4/82-ALC4/2019 |
|
|
|
|
|
, dated 19.07.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 |
|
|
|
|
|
of HBP Vol. I as |
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|
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|
per details below or as applied by firm whichever is lower: |
|
|
|
|
|
|
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|
|
|
Exportproduct |
|
|
|
|
|
|
Qty. |
|
|
|
|
SPIRONOLACTONE<br>TABLETS<br>USP<br>25<br>(ACTIVE INGREDIENT : SPIRONOLACTONE USP-NET WT. 3149.628 |
|
|
|
|
MG<br>KGS) |
|
1 Number |
|
|
|
|
SPIRONOLACTONE<br>TABLETS<br>USP<br>50<br>(ACTIVE INGREDIENT : SPIRONOLACTONE USP-NET WT. 2729.705 |
|
|
|
|
MG<br>KGS) |
|
1 Number |
|
|
| 374 |
|
SPIRONOLACTONE<br>TABLETS<br>USP<br>100<br>(ACTIVE INGREDIENT : SPIRONOLACTONE USP-NET WT. 2729.410 |
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|
|
MG<br>KGS) |
|
1 Number |
|
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|
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|
Sl. No.<br>Import items |
|
|
|
Qty. |
in mg per tablet |
|
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|
|
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|
|
|
25 mg |
50 mg |
|
100 mg |
|
|
|
|
|
|
|
|
tablet |
tablet |
|
tablet |
|
|
|
|
1<br>SPIRONOLACTONE USP |
|
|
|
25.50 |
51.00 |
|
102.00 |
|
|
|
|
2<br>CORN STARCH NF |
|
|
|
17.50 |
35.00 |
|
70.00 |
|
|
|
|
3<br>CROSCARMELLOSE SODIUM NF |
|
|
|
9.00 |
18.00 |
|
36.00 |
|
|
|
|
4<br>POVIDONE USP |
|
|
|
7.50 |
15.00 |
|
30.00 |
|
|
|
|
5<br>MICROCRYSTALLINE CELLULOSE NF<br>(COMPRECEL M102D+) |
102 |
|
|
4.50 |
9.00 |
|
18.00 |
|
|
|
|
6<br>MAGNESIUM STEARATE PH EUR/NF |
|
|
|
1.125 |
2.25 |
|
4.50 |
|
|
|
|
7<br>CALCIUM SULPHATE DIHYDRATE NF |
|
|
|
86.375 |
172.75 |
|
345.50 |
|
|
|
|
RA concerned maytake further necessaryaction asper above |
|
decision of NC. |
|
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|
|
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|
|
Case No.:1045/15/82- |
|
Party Name:SAVA |
|
Meet No/Date:7/82- |
|
Status: |
|
|
ALC4/2018 |
|
HEALTHCARE LTD. |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 375 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:3110067341 |
|
Defer Date |
|
|
:01/82/050/02502/AM19/ |
|
:31/83/040/00183/AM19/ |
|
01.03.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
| Case No.:1046/15/82- |
|
Party Name:BIOLOGICAL E |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2018 |
|
LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067234 |
|
|
| :01/82/050/02503/AM19/ |
|
:09/24/040/00536/AM19/ |
|
01.03.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in 376 meeting no. 06/82-ALC4/2019 dated 16.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
| Exportproduct |
Qty. |
Sl. No. |
Import items |
Qty. |
| DAPTOMYCIN FOR INJCTION<br>500 MG PER VIAL |
1 Number |
1 |
DAPTOMYCIN |
550 mg / 5 ml<br>vial |
RA may take appropriate action as per the decision of Norms Committee
102
| 377 |
<br>Case No.:1057/15/82-<br>ALC4/2018 |
Party Name:CIPLA LIMITED. |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02514/AM19/ |
RLA File<br>:03/94/040/01019/AM19/ |
Lic.No/Date:0310827414<br>01.03.2019 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:10/7/82-ALC4/2019 |
|
Party Name:GLOBAL |
|
Meet No/Date:7/82- |
|
Status: |
|
|
CALCIUM PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710114666 |
|
|
| :01/82/050/00505/AM20/ |
|
:07/24/040/00293/AM19/ |
|
15.03.2019 |
|
|
|
Case No.:10/7/82-ALC4/2019 |
Case No.:10/7/82-ALC4/2019 |
Case No.:10/7/82-ALC4/2019 |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00505/AM20/ |
|
|
RLA File<br>:07/24/040/00293/AM19/ |
|
|
|
Lic.No/Date:0710114666<br>15.03.2019 |
|
| 378 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 10/AM19 dated 13.11.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per<br>details given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>CALCIUM<br>LACTATE<br>GLUCONATE<br>1 kg<br>1<br>CALCIUM GLUCONATE -<br>ORAL GRADE<br>0.686 kg<br>2<br>CALCIUM CARBONATE<br>0.310 kg<br>3<br>LACTIC ACID - ANY GRADE<br>0.560 kg<br>2<br>FERROUS LACTATE<br>1 kg<br>1<br>LACTIC ACID - ANY GRADE<br>1.028 kg<br>3<br>MAGNESIUM LACTATE<br>1 kg<br>1<br>LACTIC ACID - ANY GRADE<br>1.19 kg<br>4<br>ZINC LACTATE<br>1 kg<br>1<br>LACTIC ACID - ANY GRADE<br>0.990 kg<br>5<br>MAGNESIUM<br>LACTATE<br>GLUCONATE<br>1 kg<br>1<br>LACTIC ACID -<br>ANY GRADE<br>0.390 kg<br>2<br>GLUCONO DELTA LACTONE<br>0.617 kg<br>6<br>CALCIUM LACTATE<br>1 kg<br>1<br>LACTIC ACID –<br>ANY GRADE<br>0.922 kg<br>2<br>CALCIUM CARBONATE<br>0.50 kg<br>RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
|
|
|
|
|
Sl. No. |
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
1<br> |
CALCIUM<br>LACTATE<br>GLUCONATE |
|
<br>1 kg |
1 |
CALCIUM GLUCONATE -<br>ORAL GRADE |
|
0.686 kg |
|
|
|
|
|
|
2 |
CALCIUM CARBONATE |
|
0.310 kg |
|
|
|
|
|
|
3 |
LACTIC ACID - ANY GRADE |
|
0.560 kg |
|
|
2 |
FERROUS LACTATE |
|
1 kg |
1 |
LACTIC ACID - ANY GRADE |
|
1.028 kg |
|
|
3 |
MAGNESIUM LACTATE |
|
1 kg |
1 |
LACTIC ACID - ANY GRADE |
|
1.19 kg |
|
|
4 |
ZINC LACTATE |
|
1 kg |
1 |
LACTIC ACID - ANY GRADE |
|
0.990 kg |
|
|
5<br> |
MAGNESIUM<br>LACTATE<br>GLUCONATE |
|
<br>1 kg |
1 |
LACTIC ACID -<br>ANY GRADE |
|
0.390 kg |
|
|
|
|
|
|
2 |
GLUCONO DELTA LACTONE |
|
0.617 kg |
|
|
6 |
CALCIUM LACTATE |
|
1 kg |
1 |
LACTIC ACID –<br>ANY GRADE |
|
0.922 kg |
|
|
|
|
|
|
2 |
CALCIUM CARBONATE |
|
0.50 kg |
|
|
|
take appropriate action asper the decision of Norms Committee |
|
|
|
|
|
|
103
| Case No.:11/7/82-ALC4/2019 |
|
Party Name:GLOBAL |
|
Meet No/Date:7/82- |
|
Status: |
|
|
CALCIUM PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710114740 |
|
|
| :01/82/050/00506/AM20/ |
|
:07/24/040/00310/AM19/ |
|
02.04.2019 |
|
|
|
Case No.:11/7/82-ALC4/2019 |
Case No.:11/7/82-ALC4/2019 |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00506/AM20/ |
|
RLA File<br>:07/24/040/00310/AM19/ |
|
|
Lic.No/Date:0710114740<br>02.04.2019 |
|
|
| 379 |
**Decision:**The Committee considered case as<br>experts, it was decided to ratify the ad-hoc input<br>4/82-ALC4/2018 meeting dated 19.06.2018 under<br>firm whichever is lower: |
|
|
|
per agenda and and in the presence of<br>output norms as per earlier decision taken<br>para 4.7 of HBP as per details below or a |
|
|
the technical<br>by NC in its<br>s applied by |
|
Sl.<br>No. |
Export Product |
|
Qty. |
Import Product |
|
Qty. |
|
|
1 |
MAGNESIUM LACTATE<br>GLUCONATE |
|
1 kg |
GLUCONO DELTA LACTONE |
|
0.755 kg |
|
|
2 |
ZINC GLUCONATE<br>(Eur.Ph/USP) |
|
1 kg |
GLUCONO DELTA LACTONE |
|
0.945 kg |
|
|
3 |
MAGNESIUM GLUCONATE<br>(Eur.Ph/USP) |
|
1 kg |
GLUCONO DELTA LACTONE |
|
0.945 kg |
|
|
4 |
POTASSIUM GLUCONATE<br>(USP) |
|
1 kg |
GLUCONO DELTA LACTONE |
|
0.930 kg |
|
|
5 |
FERROUS GLUCONATE<br>(BP/EP/USP) |
|
1 kg |
GLUCONO DELTA LACTONE |
|
0.887 kg |
|
|
6 |
MANGANESE GLUCONATE<br>(Eur.Ph/USP) |
|
1 kg |
GLUCONO DELTA LACTONE |
|
0.945 kg |
|
|
7 |
CALCIUM MAGNESIUM<br>LACTATE GLUCONATE |
|
1 kg |
GLUCONO DELTA LACTONE |
|
0.831 kg |
|
|
RA maytake appropriate action asper the decision |
|
|
|
of Norms Committee |
|
|
|
104
| Case No.:65/7/82-ALC4/2019 |
|
Party Name:CIPLA LIMITED. |
|
Meet No/Date:7/82- |
|
Status: |
|
|
|
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310828104 |
|
|
| :01/82/050/00560/AM20/ |
|
:03/94/040/01150/AM19/ |
|
02.04.2019 |
|
|
|
Case No.:65/7/82-ALC4/2019 |
Party Name:CIPLA LIMITED. |
Party Name:CIPLA LIMITED. |
Party Name:CIPLA LIMITED. |
Party Name:CIPLA LIMITED. |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00560/AM20/ |
RLA File<br>:03/94/040/01150/AM19/ |
|
|
|
Lic.No/Date:0310828104<br>02.04.2019 |
|
|
| 380 |
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 06/82-ALC4/2019 dated 16.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1<br>as per details given below or as applied by the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Quantity allowed<br>in mg/tablet<br>Telmisartan and Amlodipine<br>Tablets 40/10mg Each uncoated<br>tablets contains : Telmisartan 40<br>mg<br>Telmisartan 40 mg equivalent to<br>Telmisartan granules 67.36mg/<br>Amlodipine Besilate equivalent to<br>Amlodipine USP 10mg<br>1 Number<br>1<br>Telmisartan<br>Granules<br>68.034<br>2<br>Amlodipine<br>Besilate<br>10.20<br>Telmisartan and Amlodipine<br>Tablets 80/10mg Each uncoated<br>tablets contains : Telmisartan 80<br>mg<br>Telmisartan 80 mg equivalent to<br>Telmisartan granules 134.72mg<br>Amlodipine Besilate equivalent to<br>Amlodipine USP 10mg<br>1 Number<br>1<br>Telmisartan<br>Granules<br>136.067<br>2<br>Amlodipine<br>Besilate<br>10.20<br>Telmisartan and Amlodipine<br>Tablets 40/5mg Each uncoated<br>tablets contains : Telmisartan 40<br>mg<br>Telmisartan 40 mg equivalent to<br>Telmisartan granules 67.36mg<br>Amlodipine Besilate equivalent to<br>Amlodipine USP 5mg<br>1 Number<br>1<br>Telmisartan<br>Granules<br>68.034<br>2<br>Amlodipine<br>Besilate<br>5.10<br>Telmisartan and Amlodipine<br>Tablets 80/5mg Each uncoated<br>tablets contains : Telmisartan 80<br>mg<br>Telmisartan 80 mg equivalent to<br>Telmisartan granules 134.72mg<br>Amlodipine Besilate equivalent to<br>Amlodipine USP5mg<br>1 Number<br>1<br>Telmisartan<br>Granules<br>136.067<br>2<br>Amlodipine<br>Besilate<br>5.10<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
|
|
Export Product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Quantity allowed<br>in mg/tablet |
|
|
Telmisartan and Amlodipine<br>Tablets 40/10mg Each uncoated<br>tablets contains : Telmisartan 40<br>mg<br>Telmisartan 40 mg equivalent to<br>Telmisartan granules 67.36mg/<br>Amlodipine Besilate equivalent to<br>Amlodipine USP 10mg |
|
1 Number |
1 |
Telmisartan<br>Granules |
|
68.034 |
|
|
|
|
|
2 |
Amlodipine<br>Besilate |
|
10.20 |
|
|
Telmisartan and Amlodipine<br>Tablets 80/10mg Each uncoated<br>tablets contains : Telmisartan 80<br>mg<br>Telmisartan 80 mg equivalent to<br>Telmisartan granules 134.72mg<br>Amlodipine Besilate equivalent to<br>Amlodipine USP 10mg |
|
1 Number |
1 |
Telmisartan<br>Granules |
|
136.067 |
|
|
|
|
|
2 |
Amlodipine<br>Besilate |
|
10.20 |
|
|
Telmisartan and Amlodipine<br>Tablets 40/5mg Each uncoated<br>tablets contains : Telmisartan 40<br>mg<br>Telmisartan 40 mg equivalent to<br>Telmisartan granules 67.36mg<br>Amlodipine Besilate equivalent to<br>Amlodipine USP 5mg |
|
1 Number |
1 |
Telmisartan<br>Granules |
|
68.034 |
|
|
|
|
|
2 |
Amlodipine<br>Besilate |
|
5.10 |
|
|
Telmisartan and Amlodipine<br>Tablets 80/5mg Each uncoated<br>tablets contains : Telmisartan 80<br>mg<br>Telmisartan 80 mg equivalent to<br>Telmisartan granules 134.72mg<br>Amlodipine Besilate equivalent to<br>Amlodipine USP5mg |
|
1 Number |
1 |
Telmisartan<br>Granules |
|
136.067 |
|
|
|
|
|
2 |
Amlodipine<br>Besilate |
|
5.10 |
|
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 06/82-ALC4/2019 dated 16.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
105
| Case No.:12/7/82-ALC4/2019 |
|
Party Name:GLOBAL |
|
Meet No/Date:7/82- |
|
Status: |
|
|
CALCIUM PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710114937 |
|
|
| :01/82/050/00507/AM20/ |
|
:07/24/040/00032/AM20/ |
|
22.05.2019 |
|
|
|
Case No.:12/7/82-ALC4/2019 |
Case No.:12/7/82-ALC4/2019 |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00507/AM20/ |
|
RLA File<br>:07/24/040/00032/AM20/ |
|
|
|
Lic.No/Date:0710114937<br>22.05.2019 |
|
|
| 381 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 10/AM19 dated 13.11.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per<br>details given below or as applied by the firm, whichever is less:<br>Exportproduct<br>Qty.<br>Sl.No.<br>Import items<br>Qty.<br>CALCIUM LACTOBIONATE<br>1 kg<br>1.<br>CALCIUM CARBONATE<br>0.172 kg<br>2.<br>LACTOSE<br>1.16 kg<br>CALCIUM<br>BROMOLACTOBIONATE<br>1 kg<br>1.<br>CALCIUM CARBONATE<br>0.360 kg<br>2.<br>LACTOSE<br>1.021 kg<br>3.<br>HYDROBROMIC ACID<br>0.510 kg<br>CALCIUM GLUBIONATE<br>1 kg<br>1.<br>LACTOSE<br>0.515kg<br>2.<br>CALCIUM CARBONATE<br>0.135 kg<br>3.<br>CALCIUM GLUCONATE -<br>ORAL GRADE<br>0.444 kg<br>LACTOBIONIC ACID<br>1 kg<br>1.<br>CALCIUM CARBONATE<br>0.234 kg<br>2.<br>LACTOSE<br>1.58 kg<br>A maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
|
|
|
|
|
Exportproduct |
|
Qty. |
Sl.No. |
Import items |
|
Qty. |
|
|
|
CALCIUM LACTOBIONATE |
|
1 kg |
1. |
CALCIUM CARBONATE |
|
0.172 kg |
|
|
|
|
|
|
2. |
LACTOSE |
|
1.16 kg |
|
|
|
CALCIUM<br>BROMOLACTOBIONATE |
|
1 kg |
1. |
CALCIUM CARBONATE |
|
0.360 kg |
|
|
|
|
|
|
2. |
LACTOSE |
|
1.021 kg |
|
|
|
|
|
|
3. |
HYDROBROMIC ACID |
|
0.510 kg |
|
|
|
CALCIUM GLUBIONATE |
|
1 kg |
1. |
LACTOSE |
|
0.515kg |
|
|
|
|
|
|
2. |
CALCIUM CARBONATE |
|
0.135 kg |
|
|
|
|
|
|
3. |
CALCIUM GLUCONATE -<br>ORAL GRADE |
|
0.444 kg |
|
|
|
LACTOBIONIC ACID |
|
1 kg |
1. |
CALCIUM CARBONATE |
|
0.234 kg |
|
|
|
|
|
|
2. |
LACTOSE |
|
1.58 kg |
|
|
|
|
|
|
|
|
|
|
|
| 382 |
Case No.:64/7/82-ALC4/2019 |
Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00559/AM20/ |
RLA File<br>:09/24/040/00205/AM20/ |
Lic.No/Date:0910067793<br>17.07.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
106
| Case No.:13/7/82-ALC4/2019 |
|
Party Name:GLOBAL |
|
Meet No/Date:7/82- |
|
Status: |
|
|
CALCIUM PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710115189 |
|
|
| :01/82/050/00508/AM20/ |
|
:07/24/040/00095/AM20/ |
|
19.07.2019 |
|
|
|
Case No.:13/7/82-ALC4/2019 |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Lic.No/Date:0710115189<br>19.07.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00508/AM20/ |
RLA File<br>:07/24/040/00095/AM20/ |
|
|
| 383 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>CALCIUM GLUCONATE (EP FOR<br>INJECTION/JP/USP)<br>1 kg<br>1<br>CALCIUM<br>GLUCONATE<br>1.09 kg<br>CALCIUM BOROGLUCONATE<br>1 kg<br>1<br>CALCIUM<br>GLUCONATE<br>0.946 kg<br>CALCIUM GLUBIONATE(FOR<br>INJECTION) / CALCIUM<br>GLUBIONATE<br>1 kg<br>1<br>CALCIUM<br>GLUCONATE<br>0.430 kg<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
107
| Case No.:14/7/82-ALC4/2019 |
|
Party Name:GLOBAL |
|
Meet No/Date:7/82- |
|
Status: |
|
|
CALCIUM PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710115192 |
|
|
| :01/82/050/00509/AM20/ |
|
:07/24/040/00094/AM20/ |
|
19.07.2019 |
|
|
|
|
**Decision:**The Committee |
**Decision:**The Committee |
**Decision:**The Committee |
considered |
the cases as per agenda and in the light of earlier decision taken in |
the cases as per agenda and in the light of earlier decision taken in |
the cases as per agenda and in the light of earlier decision taken in |
the cases as per agenda and in the light of earlier decision taken in |
|
|
meeting |
|
no. 10/AM19 dated |
13.11.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per |
|
|
|
|
|
|
details given below or as applied by the firm, whichever is less: |
|
|
|
|
|
|
|
|
|
|
Sl. No. Export product |
|
|
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
|
|
|
No. |
|
|
|
|
|
1 |
CALCIUM |
LACTATE |
<br>1 kg |
1 |
CALCIUM GLUCONATE - |
0.686 kg |
|
|
|
|
GLUCONATE |
|
|
|
ORAL GRADE |
|
|
|
|
|
|
|
|
2 |
CALCIUM CARBONATE |
0.310 kg |
| 384 |
|
|
|
|
|
|
3 |
LACTIC ACID - ANY GRADE |
0.560 kg |
|
|
|
2 |
FERROUS LACTATE |
|
1 kg |
1 |
LACTIC ACID - ANY GRADE |
1.028 kg |
|
|
|
3 |
MAGNESIUM LACTATE |
|
1 kg |
1 |
LACTIC ACID - ANY GRADE |
1.19 kg |
|
|
|
4 |
ZINC LACTATE |
|
1 kg |
1 |
LACTIC ACID - ANY GRADE |
0.990 kg |
|
|
|
5 |
MAGNESIUM |
LACTATE |
<br>1 kg |
1 |
LACTIC ACID - |
0.390 kg |
|
|
|
|
GLUCONATE |
|
|
|
ANY GRADE |
|
|
|
|
|
|
|
|
2 |
GLUCONO DELTA LACTONE |
0.617 kg |
|
|
|
6 |
CALCIUM LACTATE |
|
1 kg |
1 |
LACTIC ACID – |
0.922 kg |
|
|
|
|
|
|
|
|
ANY GRADE |
|
|
|
|
|
|
|
|
2 |
CALCIUM CARBONATE |
0.50 kg |
|
|
RA may |
|
take appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
|
Case No.:15/7/82-ALC4/2019 |
|
Party Name:GLOBAL |
|
Meet No/Date:7/82- |
|
Status: |
|
|
|
|
CALCIUM PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
06.09.2019 |
|
|
| 385 |
|
HQ File<br>:01/82/050/00510/AM20/ |
|
RLA File<br>:07/24/040/00093/AM20/ |
|
Lic.No/Date:0710115208<br>23.07.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
|
|
authorization from RLA,Bangalore. |
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Bangalore.
108
| 386 |
Case No.:1/7/82-ALC4/2019 |
Case No.:1/7/82-ALC4/2019 |
Party Name:DR. REDDYS<br>LABORATORIES LIMITED |
Party Name:DR. REDDYS<br>LABORATORIES LIMITED |
Party Name:DR. REDDYS<br>LABORATORIES LIMITED |
Party Name:DR. REDDYS<br>LABORATORIES LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00496/AM20/ |
|
RLA File<br>:09/24/040/00245/AM20/ |
|
|
|
Lic.No/Date:0910067873<br>06.08.2019 |
|
|
|
<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>(S)-N-(1-carboxy-2-methyl-prop-1-yl)-N-<br>pentanoyl-N-[2-(1H-tetrazol-5-yl)<br>biphenyl-4-yl-methyl]<br>amine<br>barium<br>(VLS1)<br>1 kg<br>1<br>N-[(2-Cyanobiphenyl-<br>4-Methyl)] -(L)-Valine<br>Methyl ester HCl<br>0.785 kg<br>2<br>Methylene Chloride<br>2.47 kg<br>RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
|
(S)-N-(1-carboxy-2-methyl-prop-1-yl)-N-<br>pentanoyl-N-[2-(1H-tetrazol-5-yl)<br>biphenyl-4-yl-methyl]<br>amine<br>barium<br>(VLS1) |
|
1 kg |
1 |
N-[(2-Cyanobiphenyl-<br>4-Methyl)] -(L)-Valine<br>Methyl ester HCl |
|
0.785 kg |
|
|
|
|
|
|
2 |
Methylene Chloride |
|
2.47 kg |
|
|
|
|
|
|
|
|
|
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: 386
| 387 |
<br>Case No.:2/7/82-ALC4/2019 |
Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status: Deferred |
|
<br>HQ File<br>:01/82/050/00497/AM20/ |
RLA File<br>:09/24/040/00243/AM20/ |
Lic.No/Date:0910067876<br>06.08.2019 |
<br>Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| Case No.:3/7/82-ALC4/2019 |
|
Party Name:CIPLA LIMITED. |
|
Meet No/Date:7/82- |
|
Status: |
|
|
|
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310830872 |
|
|
| :01/82/050/00498/AM20/ |
|
:03/94/040/00350/AM20/ |
|
07.08.2019 |
|
|
|
Case No.:3/7/82-ALC4/2019 |
Case No.:3/7/82-ALC4/2019 |
Party Name:CIPLA LIMITED. |
Party Name:CIPLA LIMITED. |
Party Name:CIPLA LIMITED. |
Party Name:CIPLA LIMITED. |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00498/AM20/ |
|
RLA File<br>:03/94/040/00350/AM20/ |
|
|
|
Lic.No/Date:0310830872<br>07.08.2019 |
|
|
| 388 |
<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Budenase<br>AQ<br>64mcg<br>(120<br>MD)<br>Each Spray Delivers: Budesonide Ph.<br>Eur 64mcg<br>283500<br>Number<br>1<br>BUDESONIDE PH<br>EUR<br>2220.00 gm<br>RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
|
Budenase<br>AQ<br>64mcg<br>(120<br>MD)<br>Each Spray Delivers: Budesonide Ph.<br>Eur 64mcg |
|
283500<br>Number |
1 |
BUDESONIDE PH<br>EUR |
|
2220.00 gm |
|
|
|
|
|
|
|
|
|
|
|
109
|
|
Case No.:4/7/82-ALC4/2019 |
|
|
Party Name:KEVA |
|
|
Meet No/Date:7/82- |
|
Status: |
|
|
|
|
|
FRAGRANCES PRIVATE |
|
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
LIMITED |
|
|
06.09.2019 |
|
|
| 389 |
|
HQ File<br>:01/82/050/00499/AM20/ |
|
|
RLA File<br>:03/94/040/00373/AM20/ |
|
|
Lic.No/Date:0310830887<br>07.08.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
|
|
not available. Hence, it was |
decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
|
|
|
authorization from RLA,Mumbai |
|
|
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai
|
|
Case No.:20/7/82-ALC4/2019 |
|
Party Name:AMANTA |
|
Meet No/Date:7/82- |
|
Status: |
|
|
|
|
HEALTHCARE LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 390 |
|
HQ File<br>:01/82/050/00515/AM20/ |
|
RLA File<br>:08/24/040/00146/AM20/ |
|
Lic.No/Date:0810145933<br>08.08.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
|
|
authorization from RLA,Ahmedabad. |
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Ahmedabad.
|
|
Case No.:21/7/82-ALC4/2019 |
|
Party Name:GLENMARK |
|
Meet No/Date:7/82- |
|
Status: |
|
|
|
|
LIFE SCIENCES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 391 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310830914 |
|
Defer Date: |
|
|
:01/82/050/00516/AM20/ |
|
:03/94/040/00374/AM20/ |
|
09.08.2019 |
|
|
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
|
|
|
| Case No.:22/7/82-ALC4/2019 |
|
Party Name:GLENMARK |
|
Meet No/Date:7/82- |
|
Status: |
|
|
LIFE SCIENCES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310830915 |
|
|
| :01/82/050/00517/AM20/ |
|
:03/94/040/00375/AM20/ |
|
09.08.2019 |
|
|
|
|
Case No.:22/7/82-ALC4/2019Party Name:GLENMARK<br>LIFE SCIENCES LIMITED<br>Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00517/AM20/<br>RLA File<br>:03/94/040/00375/AM20/<br>Lic.No/Date:0310830915<br>09.08.2019 |
Case No.:22/7/82-ALC4/2019Party Name:GLENMARK<br>LIFE SCIENCES LIMITED<br>Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00517/AM20/<br>RLA File<br>:03/94/040/00375/AM20/<br>Lic.No/Date:0310830915<br>09.08.2019 |
Case No.:22/7/82-ALC4/2019Party Name:GLENMARK<br>LIFE SCIENCES LIMITED<br>Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00517/AM20/<br>RLA File<br>:03/94/040/00375/AM20/<br>Lic.No/Date:0310830915<br>09.08.2019 |
Case No.:22/7/82-ALC4/2019Party Name:GLENMARK<br>LIFE SCIENCES LIMITED<br>Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00517/AM20/<br>RLA File<br>:03/94/040/00375/AM20/<br>Lic.No/Date:0310830915<br>09.08.2019 |
Case No.:22/7/82-ALC4/2019Party Name:GLENMARK<br>LIFE SCIENCES LIMITED<br>Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00517/AM20/<br>RLA File<br>:03/94/040/00375/AM20/<br>Lic.No/Date:0310830915<br>09.08.2019 |
Case No.:22/7/82-ALC4/2019Party Name:GLENMARK<br>LIFE SCIENCES LIMITED<br>Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00517/AM20/<br>RLA File<br>:03/94/040/00375/AM20/<br>Lic.No/Date:0310830915<br>09.08.2019 |
Case No.:22/7/82-ALC4/2019Party Name:GLENMARK<br>LIFE SCIENCES LIMITED<br>Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00517/AM20/<br>RLA File<br>:03/94/040/00375/AM20/<br>Lic.No/Date:0310830915<br>09.08.2019 |
|
|
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in |
|
|
|
|
|
|
|
|
meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as |
|
|
|
|
|
|
|
|
per details given below or as applied by the firm, whichever is less: |
|
|
|
|
|
|
| 392 |
|
|
|
|
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl. No. |
Import items |
Qty. |
|
|
|
CILOSTAZOL |
|
1 Kg. |
1 |
5-(4-CHLOROBUTYL)-1- |
0.88 kg |
|
|
|
|
|
|
|
CYCLOHEXYL 1H TETRAZOLE |
|
|
|
|
|
|
|
2 |
6-HYDROXY-2 OXO-1,2,3,4- |
0.59 kg |
|
|
|
|
|
|
|
TETRAHYDROQUINOLINONE |
|
|
|
|
|
|
|
3 |
METHANOL |
4.00 litres |
|
|
|
|
|
|
4 |
TOLUENE |
0.30 litres |
|
|
RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
110
| Case No.:23/7/82-ALC4/2019 |
|
Party Name:BLISS GVS |
|
Meet No/Date:7/82- |
|
Status: |
|
|
PHARMA LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310830933 |
|
|
| :01/82/050/00518/AM20/ |
|
:03/94/040/00318/AM20/ |
|
09.08.2019 |
|
|
| <br> <br> |
Case No.:23/7/82-ALC4/2019 |
Party Name:BLISS GVS<br>PHARMA LIMITED |
Party Name:BLISS GVS<br>PHARMA LIMITED |
Party Name:BLISS GVS<br>PHARMA LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00518/AM20/ |
RLA File<br>:03/94/040/00318/AM20/ |
|
|
Lic.No/Date:0310830933<br>09.08.2019 |
|
|
|
| 393<br> <br> <br> <br> |
**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Gsunate-50/ Malavan-50 Artesunate<br>suppositories 50 mg( Net Contain<br>clindamycin phosphate 14.090 Kgs.)<br>1 Number<br>1<br>Artesunate<br>51.00 mg / 50<br>gm<br>suppositories<br>Gsunate-100/Malavan-100 Artesunate<br>suppositories 100 mg( Net Contain<br>clindamycin phosphate 18.780 Kgs.)<br>1 Number<br>1<br>Artesunate<br>102.00 mg /<br>100<br>gm<br>suppositories<br>Gsunate-200/ Malavan200 Artesunate<br>suppositories 200mg( Net Contain<br>clindamycin phosphate 65.170 Kgs.)<br>1 Number<br>1<br>Artesunate<br>204.00 mg /<br>204<br>gm<br>suppositories<br>RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
|
|
|
|
|
Qty. |
Sl.<br>No. |
|
Import items |
Qty. |
|
|
|
|
1 Number |
1 |
|
Artesunate |
51.00 mg / 50<br>gm<br>suppositories |
|
|
|
|
1 Number |
1 |
|
Artesunate |
102.00 mg /<br>100<br>gm<br>suppositories |
|
|
|
|
1 Number |
1 |
|
Artesunate |
204.00 mg /<br>204<br>gm<br>suppositories |
|
|
|
|
|
|
|
|
|
|
| Case No.:24/7/82- |
|
Party Name:CIPLA |
|
Meet No/Date:7/82- |
|
Status: |
| ALC4/2019 |
|
LIMITED. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:031083094 |
|
|
| :01/82/050/00519/AM20/ |
|
:03/94/040/00383/AM20/ |
|
3 |
|
|
|
|
|
|
13.08.2019 |
|
|
394
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
| Export Product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| Difluprednate<br>Ophthalmic<br>Emulsion<br>0.05%<br>Each<br>ml<br>contains<br>:<br>Difluprednate 0.05%, Sorbic<br>acid NF0.1% |
1 Number |
1 |
Difluprednate |
0.00255 gm / 5 ml pack |
111
|
|
Case No.:25/7/82-ALC4/2019 |
|
Party Name:UNILINK |
|
Meet No/Date:7/82- |
|
Status: |
|
|
|
|
PHARMA PVT LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 395 |
|
HQ File<br>:01/82/050/00520/AM20/ |
|
RLA File<br>:04/24/040/00074/AM20/ |
|
Lic.No/Date:0410165953<br>13.08.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
|
|
authorization from RLA,Chennai. |
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Chennai.
| Case No.:26/7/82-ALC4/2019 |
|
Party Name:AVA |
|
Meet No/Date:7/82- |
|
Status: |
|
|
CHEMICALS PVT.LTD., |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310830971 |
|
|
| :01/82/050/00521/AM20/ |
|
:03/94/040/00386/AM20/ |
|
14.08.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 15/82-ALC4/2018 dated 22.03.2019, it was decided to ratify norms under Para 4.7 of HBP v1 396 as per details given below or as applied by the firm, whichever is less:
| Exportproduct |
Qty. |
Sl.No. |
Import items |
Qty. |
| DISODIUM ZINC EDTA |
1 kg |
1 |
ETHYLENE DIAMINE TETRA |
0.685 kg |
| Content 15% (+/- 0.5%) |
|
|
ACETIC ACID |
|
|
|
Case No.:27/7/82-ALC4/2019 |
|
Party Name:RELIANCE |
|
Meet No/Date:7/82- |
|
Status: |
|
|
|
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 397 |
|
HQ File<br>:01/82/050/00522/AM20/ |
|
RLA File<br>:03/95/040/00364/AM20/ |
|
Lic.No/Date:0310830992<br>14.08.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
|
|
authorization from RLA,Mumbai. |
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
|
|
Case No.:28/7/82-<br>Party Name:UPL LTD. |
|
Meet No/Date:7/82- |
|
Status: Deferred |
|
|
ALC4/2019 |
|
ALC4/2019 |
|
|
|
|
|
|
06.09.2019 |
|
|
| 398 |
|
HQ File<br>:01/82/050/00523/AM20/<br>RLA File<br>:03/95/040/01337/AM19/ |
|
Lic.No/Date:0310830995<br>14.08.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
authorization from RLA,Mumbai. |
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
112
| 399 |
<br>Case No.:29/7/82-ALC4/2019 <br>HQ File<br>:01/82/050/00524/AM20/ |
Party Name:ETERNIS FINE<br>CHEMICALS LIMITED, |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
|
RLA File<br>:03/94/040/00381/AM20/ |
Lic.No/Date:0310831004<br>14.08.2019 |
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| 400 |
Case No.:32/7/82-ALC4/2019 |
Party Name:AETHER<br>INDUSTRIES LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00527/AM20/ |
RLA File<br>:52/21/040/00087/AM20/ |
Lic.No/Date:5210043145<br>14.08.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Surat. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Surat.
| 401 |
Case No.:33/7/82-ALC4/2019 |
Party Name:AETHER<br>INDUSTRIES LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00528/AM20/ |
RLA File<br>:52/21/040/00085/AM20/ |
Lic.No/Date:5210043146<br>14.08.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Surat. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Surat.
| 402 |
Case No.:34/7/82-ALC4/2019 |
Party Name:AETHER<br>INDUSTRIES LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00529/AM20/ |
RLA File<br>:52/21/040/00086/AM20/ |
Lic.No/Date:5210043147<br>14.08.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Surat. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Surat.
| 403 |
Case No.:35/7/82-ALC4/2019 |
Party Name:AETHER<br>INDUSTRIES LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00530/AM20/ |
RLA File<br>:52/21/040/00061/AM20/ |
Lic.No/Date:5210043148<br>14.08.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Surat. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Surat.
113
| Case No.:30/7/82-ALC4/2019 |
|
Party Name:SYNNAT |
|
Meet No/Date:7/82- |
|
Status: |
|
|
PHARMA PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0210209378 |
|
|
| :01/82/050/00525/AM20/ |
|
:02/24/040/00076/AM20/ |
|
16.08.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 15/82-ALC4/2018 dated 22.03.2019, it was decided to ratify norms under Para 4.7 of HBP v1 404 as per details given below or as applied by the firm, whichever is less:
| Export Product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| Noscapine BP USP Ph.Eur JP CP /<br>NoscapineHydrochlorideBP Ph.Eur |
1 kg |
1 |
Noscapine Crude Content 95% |
1.10 kg |
| 405 |
Case No.:31/7/82-ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED<br>RLA File<br>:03/95/040/00365/AM20/ |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00526/AM20/ |
|
Lic.No/Date:0310831019<br>16.08.2019 |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| Case No.:36/7/82-ALC4/2019 |
|
Party Name:S V LABS PVT |
|
Meet No/Date:7/82- |
|
Status: |
|
|
LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067890 |
|
|
| :01/82/050/00531/AM20/ |
|
:09/24/040/00253/AM20/ |
|
16.08.2019 |
|
|
|
Case No.:36/7/82-ALC4/2019 |
Party Name:S V LABS PVT<br>LTD |
Party Name:S V LABS PVT<br>LTD |
Party Name:S V LABS PVT<br>LTD |
Party Name:S V LABS PVT<br>LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br>Lic.No/Date:0910067890<br>16.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00531/AM20/ |
RLA File<br>:09/24/040/00253/AM20/ |
|
|
|
|
|
| 406 |
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less: |
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
<br>CYCLOHEXYL ESTER (CEI) |
|
1 kg |
1 |
GLYOXYLIC ACID |
|
0.743 kg |
|
|
|
|
2 |
2,5 DI HYDROXY 1,4 DITHIANE<br>(DIOL) |
|
<br>0.325 kg |
|
|
|
|
3 |
CYTOSINE |
|
0.428 kg |
|
|
|
|
4 |
HEXAMETHYL DISILAZANE<br>(HMDS) |
|
0.698 kg |
|
|
|
|
5 |
L(-)MENTHOL |
|
0.751 kg |
|
|
|
|
6 |
METHYLENE CHLORIDE<br>STABILIZED WITH AMYLENE<br>50 PPM (MDC) |
|
2.63 kg |
|
|
|
|
7 |
TRIPHOSGENE |
|
0.40 kg |
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
114
| Case No.:37/7/82-ALC4/2019 |
|
Party Name:VN CREATIVE |
|
Meet No/Date:7/82- |
|
Status: |
|
|
CHEMICALS PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831036 |
|
|
| :01/82/050/00532/AM20/ |
|
:03/95/040/00497/AM20/ |
|
16.08.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 407 applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| Tonalid |
1 kg |
1 |
D M B-1 |
0.406 kg |
|
|
2 |
Paracymene |
0.648 kg |
| 408 |
Case No.:38/7/82-ALC4/2019 |
Party Name:FRESENIUS<br>KABI INDIA PRIVATE LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00533/AM20/ |
RLA File<br>:03/94/040/00397/AM20/ |
Lic.No/Date:0310831038<br>16.08.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| Case No.:39/7/82-ALC4/2019 |
|
Party Name:TADIMETY |
|
Meet No/Date:7/82- |
|
Status: |
|
|
AROMATICS PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
LIMITED |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710115296 |
|
Defer Date: |
| :01/82/050/00534/AM20/ |
|
:07/24/040/00104/AM20/ |
|
19.08.2019 |
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is 409 not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Bangalore.
Further, the Committee considered the case as per online agenda and it was decided to call for following information from the firm:
(i) Complete 4E with all technical details i.e chemistry, molecular weight, stoichiometric reaction and % of yield on molar basis at every stage.
| 410 |
Case No.:40/7/82-ALC4/2019 |
Party Name:ORTIN<br>LABORATORIES LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00535/AM20/ |
RLA File<br>:09/24/040/00259/AM20/ |
Lic.No/Date:0910067901<br>19.08.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
115
| 411 |
Case No.:41/7/82-ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00536/AM20/ |
RLA File<br>:03/95/040/00435/AM20/ |
Lic.No/Date:0310831056<br>19.08.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| 412 |
Case No.:42/7/82-ALC4/2019 |
Party Name:NEOGEN<br>CHEMICALS LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00537/AM20/ |
RLA File<br>:03/95/040/00401/AM20/ |
Lic.No/Date:0310831058<br>19.08.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
116
| Case No.:43/7/82-ALC4/2019 |
|
Party Name:GLENMARK |
|
Meet No/Date:7/82- |
|
Status: |
|
|
PHARMACEUTICALS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831065 |
|
|
| :01/82/050/00538/AM20/ |
|
:03/94/040/00399/AM20/ |
|
19.08.2019 |
|
|
|
Case No.:43/7/82-ALC4/2019 |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00538/AM20/ |
RLA File<br>:03/94/040/00399/AM20/ |
|
|
|
Lic.No/Date:0310831065<br>19.08.2019 |
|
| 413 |
**Decision:**The Committee considered case as<br>was decided to ratify the ad-hoc input output n<br>applied by firm whichever is lower: |
|
|
per agenda in the presence of the technical experts and it<br>orms under para 4.7 of HBP as per details below or as |
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
Lithium Carbonate capsule USP<br>150mg (Pack Size 100 Tabs.) (<br>Net Wt. of Lithium Carbonate<br>USP is 750.000 Kgs) |
|
1 Number |
1 |
Lithium Carbonate USP |
|
153 mg /<br>150 mg<br>Tablet |
|
Lithium Carbonate capsule USP<br>300mg (Pack Size 100 Tabs.)<br>(Net Wt. of Lithium Carbonate<br>USP is 1500.000 Kgs) |
|
1 Number |
1 |
Lithium Carbonate USP |
|
306 mg /<br>300 mg<br>Tablet |
|
Lithium Carbonate capsule USP<br>300mg (Pack Size 1000 Tabs.)<br>(Net Wt. of Lithium Carbonate<br>USP is 15000.000 Kgs) |
|
1 Number |
1 |
Lithium Carbonate USP |
|
306 mg /<br>300 mg<br>Tablet |
|
Lithium Carbonate capsule USP<br>600mg (Pack Size 100 Tabs.)<br>(Net Wt. of Lithium Carbonate<br>USP is 3000.000 Kgs) |
|
1 Number |
1 |
Lithium Carbonate USP |
|
612 mg /<br>600 mg<br>Tablet |
|
Lithium Carbonate ER Tab USP<br>300mg (Pack Size 100 Tabs.)<br>(Net Wt. of Lithium Carbonate<br>USP is 1800.000 Kgs) |
|
1 Number |
1 |
Lithium Carbonate USP |
|
306 mg /<br>300 mg<br>Tablet |
|
Lithium Cabronate ER Tab USP<br>450MG (Pack Size 100 Tabs.)<br>(Net Wt. of Lithium Carbonate<br>USP is 2475.000 Kgs) |
|
1 Number |
1 |
Lithium Carbonate USP |
|
459 mg /<br>450 mg<br>Tablet |
|
Lithium Cabronate ER Tab USP<br>300MG (Pack Size 1000 Tabs.)<br>(Net Wt. of Lithium Carbonate<br>USP is 600.000 Kgs) |
|
1 Number |
1 |
Lithium Carbonate USP |
|
306 mg /<br>300 mg<br>Tablet |
|
RA concerned maytake further necessaryaction a |
|
|
sper above decision of NC. |
|
|
|
117
| 414 |
Case No.:44/7/82-ALC4/2019 |
Party Name:SWATI<br>MENTHOL & ALLIED<br>CHEMICALS LTD., |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00539/AM20/ |
RLA File<br>:29/24/040/00011/AM20/ |
Lic.No/Date:2910025423<br>19.08.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Moradabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Moradabad.
| 415 |
Case No.:45/7/82-ALC4/2019 |
Party Name:SUPERMINT<br>EXPORTS PRIVATE<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00540/AM20/ |
RLA File<br>:29/24/040/00010/AM20/ |
Lic.No/Date:2910025424<br>19.08.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Moradabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Moradabad.
| 416 |
Case No.:46/7/82-ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00541/AM20/ |
RLA File<br>:03/95/040/00307/AM20/ |
Lic.No/Date:0310831071<br>20.08.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| 417 |
Case No.:47/7/82-ALC4/2019 |
Party Name:NATURAL AND<br>ESSENTIAL OILS PVT LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00542/AM20/ |
RLA File<br>:07/24/040/00110/AM20/ |
Lic.No/Date:0710115306<br>20.08.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Bangalore. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Bangalore.
| 418 |
Case No.:48/7/82-ALC4/2019 |
Party Name:SRINI<br>PHARMACEUTICALS<br>PRIVATE LIMITED<br>RLA File<br>:09/24/040/00269/AM20/ |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br> <br><br>Lic.No/Date:0910067906<br>20.08.2019<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00543/AM20/ |
|
|
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
118
| 419 |
Case No.:49/7/82-ALC4/2019 |
Party Name:SRINI<br>PHARMACEUTICALS<br>PRIVATE LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00544/AM20/ |
RLA File<br>:09/24/040/00251/AM20/ |
Lic.No/Date:0910067907<br>20.08.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
| 420 |
Case No.:50/7/82-ALC4/2019 |
Party Name:DIVIS<br>LABORATORIES LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00545/AM20/ |
RLA File<br>:09/24/040/00264/AM20/ |
Lic.No/Date:0910067908<br>20.08.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
| 421 |
Case No.:51/7/82-ALC4/2019 |
Party Name:SUN<br>PHARMACEUTICAL<br>INDUSTRIES LTD. |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00546/AM20/ |
RLA File<br>:05/24/040/00291/AM20/ |
Lic.No/Date:0510411567<br>20.08.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from CLA,New Delhi. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.
| 422 |
Case No.:52/7/82-ALC4/2019 |
Party Name:PRASOL<br>CHEMICALS PRIVATE<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00547/AM20/ |
RLA File<br>:03/95/040/00513/AM20/ |
Lic.No/Date:0310831102<br>20.08.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
119
|
Case No.:53/7/8 |
Case No.:53/7/8 |
2-ALC4/2019 |
Party Name:FDC LTD |
Party Name:FDC LTD |
Party Name:FDC LTD |
Party Name:FDC LTD |
Meet No/Date:7/82- |
Status: |
|
|
|
|
|
|
|
|
<br>ALC4/2019 |
<br>Approved |
|
|
|
|
|
|
|
|
<br>06.09.2019 |
|
|
HQ File<br> |
|
|
RLA File<br> |
|
|
|
Lic.No/Date:0310831107<br> |
|
|
:01/82/050/005 |
|
8/AM20/ |
:03/94/040/00402/AM20 |
|
|
|
20.08.2019 |
|
|
Decision: |
|
The Committee |
considered the case as per |
|
|
agenda in the presence of Technical Experts and |
|
|
| 423 |
<br>in<br>the<br>light<br>, dated 16.10.20<br>per details below |
|
of<br>earlier<br>decision<br>taken<br>by<br>NC<br>18, it was decided to ratify the ad-hoc inp<br>or as applied by firm whichever is lower: |
|
|
|
<br>in<br>its<br>Meeting<br>No.<br>10/82-ALC4/2018<br>ut output norms under para 4.7 of HBP Vol. I as |
|
|
|
|
|
|
|
|
|
|
|
Qty.<br>30.6 kg |
|
|
Exportprodu |
ct |
|
Qty. |
Import items |
|
|
|
|
|
Natoptic Eye<br>Ophthalmic S |
Drops 5ml (Natamycin<br>uspension 5% w/v) |
|
120000 vials |
NATAMYCIN (MICRONISED)<br>IP |
|
|
|
|
<br>RA matake aroriate action aser the decision of Norms Committee |
|
|
|
|
|
|
|
|
|
y ppp p. |
|
|
|
|
|
|
|
|
|
|
Case No.:54/7/82-ALC4/2019 |
|
Party Name:LYRUS LIFE |
|
Meet No/Date:7/82- |
|
Status: |
|
|
|
|
SCIENCES PVT LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 424 |
|
HQ File<br>:01/82/050/00549/AM20/ |
|
RLA File<br>:07/24/040/00091/AM20/ |
|
Lic.No/Date:0710115309<br>20.08.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
|
|
authorization from RLA,Bangalore |
|
|
|
|
|
|
|
|
Case No.:55/7/82-ALC4/2019 |
|
Party Name:GLENMARK |
|
Meet No/Date:7/82- |
|
Status: |
|
|
|
|
LIFE SCIENCES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 425 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310831109 |
|
Defer Date: |
|
|
:01/82/050/00550/AM20/ |
|
:03/94/040/00404/AM20/ |
|
21.08.2019 |
|
|
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:56/7/82-ALC4/2019 |
|
Party Name:GLOBAL |
|
Meet No/Date:7/82- |
|
Status: |
|
|
|
|
CALCIUM PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
06.09.2019 |
|
|
| 426 |
|
HQ File<br>:01/82/050/00551/AM20/ |
|
RLA File<br>:07/24/040/00107/AM20/ |
|
Lic.No/Date:0710115314<br>21.08.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
|
|
authorization from RLA,Bangalore. |
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Bangalore.
120
| Case No.:57/7/82-ALC4/2019 |
|
Party Name:LANTECH |
|
Meet No/Date:7/82- |
|
Status: |
|
|
PHARMACEUTICALS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067919 |
|
|
| :01/82/050/00552/AM20/ |
|
:09/24/040/00255/AM20/ |
|
21.08.2019 |
|
|
|
Case No.:57/7/82-ALC4/2019 |
Party Name:LANTECH<br>PHARMACEUTICALS LTD |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00552/AM20/ |
RLA File<br>:09/24/040/00255/AM20/ |
Lic.No/Date:0910067919<br>21.08.2019 |
|
| 427 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>5-(4-Amino-2-oxo-1(2H)-<br>pyrimidinyl)-1,3-oxathiolane-2-<br>carboxylic acid 5-methyl-2-(1-<br>methylethyl) cyclohexyl ester<br>1 kg<br>1<br>Glyoxalic acid (50%)<br>0.746 kg<br>2<br>Menthol (L-Menthol)<br>0.751 kg<br>3<br>2,5-Dihydroxy-1,4-dithiane<br>0.327 kg<br>4<br>Toluene<br>0.50 kg<br>5<br>Cyclohexane<br>0.79 kg<br>6<br>Hexanes<br>1.13 kg<br>7<br>Methylene dichloride<br>2.87 kg<br>8<br>Cytosine<br>0.434 kg<br>9<br>Hexamethyldisilazane<br>0.708 kg<br>10<br>Triphosgene<br>0.50 kg<br>11<br>Triethylamine<br>0.53 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
Case No.:58/7/82-ALC4/2019 Party Name:GLENMARK Meet No/Date:7/82- Status: PHARMACEUTICALS LTD ALC4/2019 Approved 06.09.2019 HQ File RLA File Lic.No/Date:0310831153 :01/82/050/00553/AM20/ :03/94/040/00405/AM20/ 22.08.2019 Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 10/82-ALC4/2018 , dated 13.11.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
428
| Export Product |
Qty. |
Sl. |
Import Product |
Qty. |
|
|
No. |
|
|
| Colesevelam HCL for oral |
1 Number |
1 |
Colesevelam Hydrochloride |
3.9375 gm / bottle |
| suspension 3.75 GM (Pack |
|
|
|
|
| size 30s) |
|
|
|
|
| (Net. Content of |
|
|
|
|
| Colesevelam |
|
|
|
|
| Hydrochloride is 4500.000 |
|
|
|
|
| kgs) |
|
|
|
|
RA concerned may take further necessary action as per above decision of NC
121
| 429 |
Case No.:59/7/82-ALC4/2019 |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00554/AM20/ |
RLA File<br>:07/24/040/00117/AM20/ |
Lic.No/Date:0710115318<br>22.08.2019 |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Bangalore. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Bangalore.
| 430 |
Case No.:60/7/82-ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00555/AM20/ |
RLA File<br>:03/95/040/00514/AM20/ |
Lic.No/Date:0310831219<br>26.08.2019 |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| Case No.:61/7/82-ALC4/2019 |
|
Party Name:GLENMARK |
|
Meet No/Date:7/82- |
|
Status: |
|
|
LIFE SCIENCES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831222 |
|
|
| :01/82/050/00556/AM20/ |
|
:03/94/040/00421/AM20/ |
|
26.08.2019 |
|
|
|
Case No.:61/7/82-ALC4/2019 |
Case No.:61/7/82-ALC4/2019 |
Party Name:GLENMARK<br>LIFE SCIENCES LIMITED<br>RLA File<br>:03/94/040/00421/AM20/ |
Party Name:GLENMARK<br>LIFE SCIENCES LIMITED<br>RLA File<br>:03/94/040/00421/AM20/ |
Party Name:GLENMARK<br>LIFE SCIENCES LIMITED<br>RLA File<br>:03/94/040/00421/AM20/ |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br> <br><br>Lic.No/Date:0310831222<br>26.08.2019 |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br> <br><br>Lic.No/Date:0310831222<br>26.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00556/AM20/ |
|
|
|
|
|
|
|
| 431 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less: |
|
|
|
|
|
|
|
|
<br>Export product |
Qty. |
|
Sl. No. |
Import items |
|
Qty. |
|
|
CILOSTAZOL |
1 Kg. |
|
1 |
5-(4-CHLOROBUTYL)-1-<br>CYCLOHEXYL 1H TETRAZOLE |
|
0.88 kg |
|
|
|
|
|
2 |
6-HYDROXY-2 OXO-1,2,3,4-<br>TETRAHYDROQUINOLINONE |
|
0.59 kg |
|
|
|
|
|
3 |
METHANOL |
|
4.00 litres |
|
|
|
|
|
4 |
TOLUENE |
|
0.30 litres |
|
|
RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
| 432 |
Case No.:62/7/82-ALC4/2019 |
Party Name:HETERO LABS<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00557/AM20/ |
RLA File<br>:09/24/040/00273/AM20/ |
Lic.No/Date:0910067935<br>26.08.2019 |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad
122
| Case No.:63/7/82-ALC4/2019 |
|
Party Name:STERILE INDIA |
|
Meet No/Date:7/82- |
|
Status: |
|
|
PRIVATE LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510411631 |
|
|
| :01/82/050/00558/AM20/ |
|
:05/24/040/00257/AM20/ |
|
26.08.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decisions taken in meeting no. 1/82-ALC4/2019 dated 03.06.2019, it was decided to ratify norms under Para 4.7 of HBP v1 433 as per details given below or as applied by the firm, whichever is less:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| CEFEPIME FOR INJECTION |
1 kg |
1 |
CEFEPIME HCL (NON- |
0.655 kg |
|
|
|
STERILE) |
|
RA may take appropriate action as per the decision of Norms Committee.
|
|
Case No.:67/7/82-ALC4/2019 |
|
Party Name:RELIANCE |
|
Meet No/Date:7/82- |
|
Status: |
|
|
|
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 434 |
|
HQ File<br>:01/82/050/00562/AM20/ |
|
RLA File<br>:03/95/040/00496/AM20/ |
|
Lic.No/Date:0310831247<br>27.08.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
|
|
authorization from RLA,Mumbai |
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai
|
|
Case No.:68/7/82-ALC4/2019 |
|
Party Name:NEOGEN |
|
Meet No/Date:7/82- |
|
Status: |
|
|
|
|
CHEMICALS LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
06.09.2019 |
|
|
| 435 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310831251 |
|
Defer Date: |
|
|
:01/82/050/00563/AM20/ |
|
:03/95/040/00310/AM20/ |
|
27.08.2019 |
|
|
|
|
**Decision:**New Case,deferred |
|
for comments of TE. |
|
|
|
|
| Case No.:69/7/82-ALC4/2019 |
|
Party Name:O C |
|
Meet No/Date:7/82- |
|
Status: |
|
|
SPECIALITIES PVT.LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831252 |
|
|
| :01/82/050/00564/AM20/ |
|
:03/95/040/00528/AM20/ |
|
27.08.2019 |
|
|
| **Decision:**The Committee considered case |
**Decision:**The Committee considered case |
**Decision:**The Committee considered case |
as per |
agenda and in the presence of the technical experts |
agenda and in the presence of the technical experts |
|
| and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as |
|
|
|
|
|
|
| applied by firm whichever is lower: |
|
|
|
|
|
|
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
No. |
|
|
|
|
3-CHLORO-2-HYDRAZINE |
1 kg |
1 |
3 AMINO PYRIDINE |
1.30 kg |
|
|
PYRIDINE (KC-190) |
|
2 |
HYDROGEN PEROXIDE(50%) |
0.942 kg |
|
|
|
|
3 |
SODIUM NITRITE |
0.950 kg |
|
|
|
|
4 |
HYDRAZINE HYDRATE 80% |
1.26 kg |
|
| RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: 436
123
| Case No.:70/7/82-ALC4/2019 |
|
Party Name:AVA |
|
Meet No/Date:7/82- |
|
Status: |
|
|
CHEMICALS PVT.LTD., |
|
ALC4/2019 |
|
Approved |
|
|
|
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831253 |
|
|
| :01/82/050/00565/AM20/ |
|
:03/94/040/00425/AM20/ |
|
27.08.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in 437 meeting no. 15/82-ALC4/2018 dated 22.03.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
| Exportproduct |
Qty. |
Sl. No. |
Import items |
Qty. |
| EDTA FERRIC SODIUM Fe |
1 kg |
1 |
ETHYLENE DIAMINE |
0.730 kg |
| content 13% ( +/- 0.5) |
|
|
TETRA ACETIC ACID |
|
| 438 |
Case No.:71/7/82-ALC4/2019 |
Party Name:SYNTHO<br>CHIRALS PVT. LTD<br>RLA File<br>:09/24/040/00275/AM20/ |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00566/AM20/ |
|
Lic.No/Date:0910067938<br>27.08.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad
| 439 |
Case No.:72/7/82-ALC4/2019 |
Party Name:AUROBINDO<br>PHARMA LIMITED<br>RLA File<br>:09/24/040/00274/AM20/ |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00567/AM20/ |
|
Lic.No/Date:0910067940<br>27.08.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
| Case No.:73/7/82-ALC4/2019 |
|
Party Name:SUN |
|
Meet No/Date:7/82- |
|
Status: |
|
|
PHARMACEUTICAL |
|
ALC4/2019 |
|
Approved |
|
|
INDUSTRIES LTD. |
|
06.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510411647 |
|
|
| :01/82/050/00568/AM20/ |
|
:05/24/040/00269/AM20/ |
|
27.08.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 15/82-ALC4/2018 dated 22.03.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
440
| Export Product |
Qty. |
Sl.No. |
Import items |
Qty.<br>153 gram |
| Nepafenac Ophthalmic Suspension,<br>0.1% w/v NEPALACT Sterile Eye<br>Drops,<br>5ml)<br>(PRANAYAM)<br>(Each ml contains Nepafenac 1.0 mg<br>(Equivalent to 150.000 Gram of Bulk<br>Drug) |
30000<br>Numbers |
<br>1 |
NEPAFENAC |
|
124
| 441 |
<br>Case No.:74/7/82-ALC4/2019 |
Party Name:UNICHEM<br>LABORATORIES LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00569/AM20/ |
RLA File<br>:03/95/040/00541/AM20/ |
Lic.No/Date:0310831283<br>28.08.2019 |
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| 442 |
Case No.:75/7/82-ALC4/2019 |
Party Name:HETERO LABS<br>LIMITED<br>RLA File<br>:09/24/040/00293/AM20/ |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00570/AM20/ |
|
Lic.No/Date:0910067948<br>28.08.2019 |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
| 443 |
<br>Case No.:76/7/82-ALC4/2019 |
Party Name:HETERO LABS<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00571/AM20/ |
RLA File<br>:09/24/040/00284/AM20/ |
Lic.No/Date:0910067949<br>28.08.2019 |
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
|
|
|
|
|
| 444 |
<br>Case No.:77/7/82-ALC4/2019 |
Party Name:HETERO LABS<br>LIMITED |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00572/AM20/ |
RLA File<br>:09/24/040/00291/AM20/ |
Lic.No/Date:0910067953<br>28.08.2019 |
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| 445 |
Case No.:78/7/82-ALC4/2019 |
Party Name:HETERO LABS<br>LIMITED<br> <br> <br> <br>RLA File<br>:09/24/040/00292/AM20/<br> <br> |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019<br> <br><br>Lic.No/Date:0910067954<br>28.08.2019<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00573/AM20/ |
|
|
Defer Date: |
|
**Decision:**New Case, deferred |
for comments of TE. |
|
|
|
|
|
|
|
| 446 |
Case No.:79/7/82-ALC4/2019 |
Party Name:SENTISS<br>PHARMA PVT.LTD.<br>RLA File<br>:05/24/040/00292/AM20/ |
Meet No/Date:7/82-<br>ALC4/2019<br>06.09.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00574/AM20/ |
|
Lic.No/Date:0510411666<br>28.08.2019 |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from CLA,New Delhi, |
|
|
|
125
MANUAL CASES
| Case No. |
A-1 |
| Meeting No. |
7/AM20 |
| Date |
24.09.2019 |
| Firm’s Name |
M/s Adishank Chemicals Pvt. Ltd., Mumbai |
| HQ F. No. |
01/82/050/00422/AM15/DES-III |
| RLA F. No. |
03/94/040/01140/AM14 |
| Advance Authorization No. and Date |
0310777786 dated 09.04.2014 |
| Subject |
Request of M/s Adhishank Chemicals Pvt. Ltd Mumbai, for<br>fixation of adhoc norms against Advance Authorization No.<br>0310777786 dated 09.04.2014 |
| **Decision:**The Committee considered the request of firm as per agenda in the presence of technical experts<br>and it was decided to call for following information from the firm:<br>(i)<br>Commercial value of recovered Phenol in the process. |
|
|
Case No. |
A-2 |
|
Meeting No. |
7/AM20 |
|
Date |
24.09.2019 |
|
Firm’s Name |
M/s Adishank Chemicals Pvt. Ltd., Mumbai |
|
HQ F. No. |
01/82/050/01243/AM19/DES-III |
|
RLA F. No. |
03/94/040/00178/AM19 |
|
Advance Authorization No. and Date |
0310822825 dated 02.08.2018 |
|
Subject |
Request of M/s Adishank Chemicals Pvt. Ltd., Mumbai for<br>revision/correction in adhoc norms fixed against Advance<br>AuthorizationNo. 0310822825 dated 02.08.2018 |
| <br> <br> |
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it was<br>decided to revise the quantity of Import Item No. 2 as under:<br>Import Item No. 2<br>Qty.<br>From<br>To<br>2– Propyl Heptanol<br>0.386 kg<br>0.444 kg<br>Rest of the earlier Minutes would remain unchanged.<br>RA concerned may take further necessary action as per above decision of NC. |
|
126
|
Case No. |
Case No. |
A-3 |
A-3 |
A-3 |
A-3 |
|
Meeting No. |
|
7/AM20 |
|
|
|
|
Date |
|
24.09.2019 |
|
|
|
|
Firm’s Name |
|
M/s Eternis Fine Chemicals Ltd., Mumbai |
|
|
|
|
HQ F. No. |
|
01/82/050/01311/AM19/DES-III |
|
|
|
|
RLA F. No. |
|
03/94/040/00593/AM19 |
|
|
|
|
Advance Authorization No. and Date |
|
0310824249 dated 05.10.2018 |
|
|
|
|
Subject |
|
Request of M/s Eternis Fine Chemicals Ltd., Mumbai for<br>revision in adhoc norms fixed against Advance Authorization<br>No. 0310824249 dated 05.10.2018 |
|
|
|
|
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it was<br>decided to revise the adhoc norms under para 4.7 of HBP Vol. I as per details below or as applied by firm<br>whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty.<br>Ortho Tertiary Butyl Cyclohexyl<br>Acetate and or Ortho Tertiary<br>Butyl Cyclohexyl Acetate Super<br>1 kg<br>1<br>PHENOL<br>0.800 kg<br>2<br>ISOBUTYLENE<br>0.300 kg<br>3<br>ACETIC ANHYDRIDE<br>0.123 kg<br>4<br>5% RUTHENIUM ON CARBON<br>CATALYST<br>0.000015 kg<br>5<br>METHANOL<br>0.330 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
|
Export Product |
Qty. |
|
Sl.<br>No. |
Import Items |
Qty. |
|
Ortho Tertiary Butyl Cyclohexyl<br>Acetate and or Ortho Tertiary<br>Butyl Cyclohexyl Acetate Super |
1 kg |
|
1 |
PHENOL |
0.800 kg |
|
|
|
|
2 |
ISOBUTYLENE |
0.300 kg |
|
|
|
|
3 |
ACETIC ANHYDRIDE |
0.123 kg |
|
|
|
|
4 |
5% RUTHENIUM ON CARBON<br>CATALYST |
0.000015 kg |
|
|
|
|
5 |
METHANOL |
0.330 kg |
|
RA concerned may take further necessary action as |
|
|
|
per above decision of NC. |
|
|
Case No. |
A-4 |
|
Meeting No. |
7/AM20 |
|
Date |
24.09.2019 |
|
Firm’s Name |
M/s Eternis Fine Chemicals Ltd., Mumbai |
|
HQ F. No. |
01/82/050/02380/AM19/DES-III |
|
RLA F. No. |
03/94/040/01000/AM19 |
|
Advance Authorization No. and Date |
0310827203 dated 21.02.2019 |
|
Subject |
Request of M/s Eternis Fine Chemicals Ltd., Mumbai for<br>revision/correction in adhoc norms fixed against Advance<br>Authorization No. 0310827203 dated 21.02.2019 |
|
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it was<br>decided to revise the adhoc norms under para 4.7 of HBP Vol. I as per details below or as applied by firm<br>whichever is lower:<br>Export Product<br>Qty.<br>S.<br>**No **<br>Import Items<br>Qty.<br>COUMARIN<br>1 kg<br>1<br>SALICYLALDEHYDE<br>1.09 kg<br>2<br>ACETIC ANHYDRIDE<br>0.91 kg<br>3<br>METHANOL<br>0.06 kg<br>RAconcernedmay takefurther necessary actionas perabove decisionofNC. |
|
127
|
Case No. |
A-5 |
|
Meeting No. |
7/AM20 |
|
Date |
24.09.2019 |
|
Firm’s Name |
M/s SMB Corporation of India, Mumbai |
|
HQ F. No. |
01/82/050/00779/AM16/DES-III |
|
RLA F. No. |
03/95/040/00039/AM16 |
|
Advance Authorization No. and Date |
0310795601 dated 28.04.2015 |
|
Subject |
Request of M/s SMB Corporation of India, Mumbai for<br>correction in the adhoc norms fixed against Advance<br>Authorization No. 0310795601 dated 28.04.2015 |
| <br> <br> |
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and<br>taking cue from SION at S.No. K-41, it was decided to revise the quantity of Import Item No. 6 as under:<br>Import Item No. 6<br>Qty.<br>From<br>To<br>COMPOUND OF LDPE RESIN AND<br>BARIUM SULPHATE ( GRANULES)<br>0.000415 kg<br>0.00049 kg<br>Rest of the earlier Minutes would remain unchanged.<br>RA concerned may take further necessary action as per above decision of NC. |
|
| Case No. |
A-6 |
| Meeting No. |
7/AM20 |
| Date |
24.09.2019 |
| Firm’s Name |
M/s Sunshield Chemicals Ltd. (Solvay Group), Mumbai |
| HQ F. No. |
01/82/050/00899/AM16/DES-III |
| RLA F. No. |
03/95/040/00266/AM16 |
| Advance Authorization No. and Date |
0310797135 dated 09.07.2015 |
| Subject |
Request of M/s Sunshield Chemicals Ltd. (Solvay Group),<br>Mumbai for amendment in the adhoc norms fixed by NC-3<br>against Advance Authorization No. 0310797135 dated<br>09.07.2015 |
| **Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to revise the adhoc norms under para 4.7 of HBP Vol. I as per details below or as applied by<br>firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>THEIC -TRIS ( 2-HYDROXY<br>ETHYL) ISOCYANURATE<br>1 kg<br>1<br>CYANURIC ACID<br>0.541 kg<br>2<br>ETHYLENE OXIDE<br>0.582 kg<br>3<br>METHANOL<br>0.098 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
128
| Case No. |
A-7 |
| Meeting No. |
7/AM20 |
| Date |
24.09.2019 |
| Firm’s Name |
M/s Sunshield Chemicals Ltd. (Solvay Group), Mumbai |
| HQ F. No. |
01/82/050/00008/AM19/DES-III |
| RLA F. No. |
03/95/040/00853/AM18 |
| Advance Authorization No. and Date |
0310818560 dated 17.01.2018 |
| Subject |
Request of M/s Sunshield Chemicals Ltd. (Solvay Group),<br>Mumbai for enhancement in the quantity of adhoc norms<br>fixed by Norms Committee against Advance Authorization<br>No. 0310818560 dated 17.01.2018 |
| **Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to revise the adhoc norms under para 4.7 of HBP Vol. I as per details below or as applied by<br>firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>THEIC -TRIS ( 2-HYDROXY<br>ETHYL) ISOCYANURATE<br>1 kg<br>1<br>CYANURIC ACID<br>0.541 kg<br>2<br>ETHYLENE OXIDE<br>0.582 kg<br>3<br>METHANOL<br>0.098 kg<br>RAconcernedmay takefurther necessary actionas perabove decisionofNC. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Ca |
se No. |
|
|
A-8 |
|
|
|
|
|
|
|
|
| M |
eeting No. |
|
|
7/AM20 |
|
|
|
|
|
|
|
|
| Da |
te |
|
|
24.09.2019 |
|
|
|
|
|
|
|
|
| Fi |
’N |
|
|
M/ Shild Chi |
|
|
|
l Pt Ltd Mbi |
|
|
|
|
| rms ame |
|
|
|
s unse emcas v. ., uma |
|
|
|
|
|
|
|
|
| HQ F. No. |
|
|
|
01/82/050/01652/AM18/DES-III |
|
|
|
|
|
|
|
|
| RLA F. No. |
|
|
|
03/95/040/00182/AM19 |
|
|
|
|
|
|
|
|
| <br>Ad |
<br>vance Authorization No. and Dat |
|
e |
<br>0310821302 dated 29.05.2 |
|
|
|
|
018 |
|
|
|
| Su |
bject |
|
|
Request of M/s Sunshi<br>revision of norms in re |
|
|
|
|
eld Chemicals Pvt. Ltd.,<br>spect of norms fixed aga |
|
|
Mumbai for<br>inst Advance |
|
|
|
|
<br>Authorization No. 03108 |
|
|
|
|
<br>21302 dated 29.05.2018 |
|
|
|
| De<br>de<br>wh |
**cision:**The Committee considered the case as<br>cided to revise the adhoc norms under para 4.7<br>ichever is lower: |
|
|
|
|
per agenda in the presence of technical experts and it was<br>of HBP Vol. I as per details below or as applied by firm |
|
|
|
|
|
|
| Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>THEIC -TRIS ( 2-HYDROXY<br>ETHYL) ISOCYANURATE<br>1 kg<br>1<br>CYANURIC ACID<br>2<br>ETHYLENE OXIDE<br>3<br>METHANOL<br>RAconcernedmay takefurther necessary actionas perabove decisionofNC. |
|
|
|
|
|
|
|
|
|
Qty.<br>0.541 kg<br>0.582 kg<br>0.098 kg |
|
|
|
Export product |
|
|
|
Qty. |
Sl.<br>No. |
Import items |
|
|
Qty. |
|
|
|
THEIC -TRIS ( 2-HYDROXY<br>ETHYL) ISOCYANURATE |
|
|
|
1 kg |
1 |
CYANURIC ACID |
|
|
0.541 kg |
|
|
|
|
|
|
|
|
2 |
ETHYLENE OXIDE |
|
|
0.582 kg |
|
|
|
|
|
|
|
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3 |
METHANOL |
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0.098 kg |
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129
| Case No. |
Case No. |
Case No. |
A-9 |
A-9 |
A-9 |
A-9 |
A-9 |
A-9 |
A-9 |
A-9 |
A-9 |
A-9 |
| Me |
eting No. |
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7/AM20 |
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| Da |
te |
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24.09.2019 |
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| Fir<br> |
m’s Name<br> |
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M/s Sunshield Chemicals<br> |
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Pvt. Ltd., Mumbai<br> |
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| HQ |
F. No. |
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01/82/050/00549/AM18/D |
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ES-III |
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| RL |
A F. No. |
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03/95/040/00298/AM18 |
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| Ad |
Ahii N d D |
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0310814546 dd 11072 |
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17 |
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vance utorzaton o. an ate |
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ate .. |
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| Su |
bject |
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Request of M/s Sunshield Chemicals Pvt. Ltd., Mumbai for<br>fixation of adhoc norms in respect of Advance Authorization<br>No. 0310814546 dated 11.07.2017 |
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| De<br>dec<br>wh<br>RA |
**cision:**The Committee considered the c<br> |
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ase as pe<br> |
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r agend<br> |
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a in the presence of technical exper<br> |
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ts and it was<br>lied by firm<br>kg<br>kg |
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ided to ratify the adhoc norms under para<br>ichever is lower: |
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4.7 of |
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BP V |
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ol. I as per details below o |
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r as app |
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Export product |
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Qty. |
Sl<br>N |
.<br>o. |
Im |
port items |
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Qty. |
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SUNOX 1022 D BIS<br>(NONYLPHENYL AMINE) |
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1 kg |
1 |
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N |
onene(Propylene Trimer) |
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0.651 |
kg |
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2 |
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D |
I Phenylamine |
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0.455 |
kg |
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concerned may take further necessary actio |
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n as per |
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above d |
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ecision of NC. |
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| Case No. |
Case No. |
Case No. |
A-10 |
A-10 |
A-10 |
A-10 |
A-10 |
A-10 |
A-10 |
A-10 |
A-10 |
| <br>Me |
<br>eting No. |
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<br>7/AM20 |
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| Da |
te |
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24.09.2019 |
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| Fir |
m’s Name |
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M/s Sunshield Chemicals |
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Pvt. Ltd., Mumbai |
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| HQ |
F. No. |
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01/82/050/00528/AM18/D<br>01/82/050/01106/AM19/D<br> |
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ES-III<br>ES-III<br> |
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01/82/050/02558/AM19/DES-III |
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| RL |
A F. No. |
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03/95/040/00355/AM18<br>03/95/040/00473/AM19<br>03/95/040/01312/AM19 |
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| Ad |
vance Authorization No. and Date |
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0310814918 dated 31.07.2017<br>0310823049 dated 14.08.2018<br>0310827658 dated 13.03.2019 |
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<br> |
0310823<br>0310827 |
049 dated<br>658 dtd |
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4.08.2018<br>3032019 |
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ae |
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.. |
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| Su |
bject |
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Request<br>revision<br>Authori<br>dated 1 |
of M/s<br>of norms<br>zation N |
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Sunshield Chemicals Pvt. Ltd.<br>in respect of norms fixed ag<br>0310814918 dated 3107201 |
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, Mumbai for<br>ainst Advance<br>8, 0310823049 |
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<br>4.08.2018 |
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. ..<br>& 0310827658 dated 13.03.2019 |
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| De<br>dec |
<br>**cision:**The Committee considered the case as<br>ided to revise the adhoc norms under para 4.7 |
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<br>per agenda in the presence of technical experts and it was<br>of HBP Vol. I as per details below or as applied by firm |
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| <br>whichever is lower:<br> <br>Export product<br>Qty.<br>SUN<br>HQEE<br>(Hydroquinone<br>Ethoxylate)<br>1 kg<br>RA concerned may take further necessary action as |
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<br>Qty.<br>0.667 kg<br>0.601 kg |
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Export product |
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Qty. |
Sl.<br>No. |
Import items |
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|
Qty. |
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|
SUN<br>HQEE<br>(Hydroquinone<br>Ethoxylate) |
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|
1 kg |
1 |
Hydroquinone |
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|
0.667 kg |
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2 |
Ethylene Oxide |
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|
0.601 kg |
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per above decision of NC. |
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130
|
Case No. |
A-11 |
A-11 |
A-11 |
A-11 |
A-11 |
|
Meeting No. |
7/AM20 |
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|
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Date |
24.09.2019 |
|
|
|
|
|
Firm’s Name |
M/s Sunshield Chemicals Pvt. Ltd., Mumbai |
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|
HQ F. No. |
01/82/050/00145/AM17/DES-III<br>01/82/050/01854/AM16/DES-III |
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RLA F. No. |
03/95/040/00967/AM16<br>03/95/040/00771/AM16<br>03/95/040/00649/AM17<br>03/95/040/00248/AM18 |
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Advance Authorization No. and Date |
0310803283 dated 14.03.2016<br>0310801856 dated 18.01.2016<br>0310809299 dated 24.11.2016<br>0310814364 dated 30.06.2017 |
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|
|
Subject |
Request of M/s Sunshield Chemicals Pvt. Ltd., Mumbai for<br>deletion of condition of submission of actual production and<br>consumption data duly certified by Central Excise at RLA,<br>Mumbai at the time of redemption |
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|
**Decision:**The Committee considered the case as<br>decided to revise the adhoc norms under para 4.7<br>whichever is lower: |
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|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
Qty. |
|
THEIC-TRIS (2-Hydroxy Ethyl) Isocyanurate |
|
1 kg |
1 |
Cyanuric Acid |
0.541 kg |
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|
2 |
Ethylene Oxide |
0.582 kg |
|
|
|
|
3 |
Methanol |
0.098 kg |
|
RA concerned may take further necessary action as per above decision of NC. |
|
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|
|
| Case No. |
A-12 |
| Meeting No. |
7/AM20 |
| Date |
24.09.2019 |
| Firm’s Name |
M/s Smilax Laboratories Limited, Hyderabad |
| HQ F. No. |
01/82/050/01293/AM15/DES-III |
| RLA F. No. |
09/24/040/00378/AM15 |
| Advance Authorization No. and Date |
0910061161 dated 30.10.2014 |
| Subject |
Request of M/s Smilax Laboratories Limited, Hyderabad<br>for enhancement in the quantity of Import Item Nos. 1, 3<br>and 6 of adhoc norms fixed by NC-3 against Advance<br>Authorization No. 0910061161 dated 30.10.2014 |
| **Decision:**The Committee considered the request of the firm in the presence of technical experts and it<br>was observed that the firm has not furnished any technical justification for enhancement of norms. Hence,<br>the Committee decided to reject the request of the firm maintaining the status quo. |
|
131
| Case No. |
A-13 |
| Meeting No. |
7/AM20 |
| Date |
24.09.2019 |
| Firm’s Name |
M/s Smilax Laboratories Limited, Hyderabad |
| HQ F. No. |
01/82/050/00562/AM13/DES-III |
| RLA F. No. |
09/24/040/00149/AM13 |
| Advance Authorization No. and Date |
0910053215 dated 09.07.2012 |
| Subject |
Request of M/s Smilax Laboratories Limited, Hyderabad<br>for enhancement in the quantity of Import Item Nos. 3, 4, 6,<br>12 and 15 of adhoc norms fixed by NC-3 against Advance<br>Authorization No. 0910053215 dated 09.07.2012 |
| **Decision:**The Committee considered the request of the firm in the presence of technical experts and it<br>was observed that the firm has not furnished any technical justification for enhancement of norms. Hence,<br>the Committee decided to reject the request of the firm maintaining the status quo. |
|
| Case No. |
A-14 |
| Meeting No. |
7/AM20 |
| Date |
24.09.2019 |
| Firm’s Name |
M/s Smilax Laboratories Limited, Hyderabad |
| HQ F. No. |
01/82/050/01218/AM14/DES-III |
| RLA F. No. |
09/24/040/00382/AM14 |
| Advance Authorization No. and Date |
0910058170 dated 08.11.2013 |
| Subject |
Request of M/s Smilax Laboratories Limited, Hyderabad<br>for enhancement in the quantity of Import Item No. 1 of<br>adhoc norms fixed by NC-3 against Advance Authorization<br>No. 0910058170 dated 08.11.2013 |
| **Decision:**The Committee considered the request of the firm in the presence of technical experts and it<br>was observed that the firm has not furnished any technical justification for enhancement of norms. Hence,<br>the Committee decided toreject therequest ofthefirm maintaining the status quo. |
|
| Case No. |
A-15 |
| Meeting No. |
7/AM20 |
| Date |
24.09.2019 |
| Firm’s Name |
M/s Smilax Laboratories Limited, Hyderabad |
| HQ F. No. |
01/82/050/00117/AM16/DES-III |
| RLA F. No. |
09/24/040/00710/AM15 |
| Advance Authorization No. and Date |
0910061858 dated 31.03.2015 |
| Subject |
Request of M/s Smilax Laboratories Limited, Hyderabad<br>for enhancement in the quantity of Import Item Nos. 1 to 5<br>of<br>adhoc<br>norms<br>fixed<br>by<br>NC-3<br>against<br>Advance<br>Authorization No. 0910061858 dated 31.03.2015 |
| **Decision:**The Committee considered the request of the firm in the presence of technical experts and it<br>was observed that the firm has not furnished any technical justification for enhancement of norms. Hence,<br>the Committee decided to reject the request of the firm maintaining the status quo. |
|
132
| Case No. |
A-16 |
| Meeting No. |
7/AM20 |
| Date |
24.09.2019 |
| Firm’s Name |
M/s Smilax Laboratories Limited, Hyderabad |
| HQ F. No. |
01/82/050/00886/AM14/DES-III |
| RLA F. No. |
09/24/040/00180/AM14 |
| Advance Authorization No. and Date |
0910056902 dated 25.07.2013 |
| Subject |
Request of M/s Smilax Laboratories Limited, Hyderabad<br>for enhancement in the quantity of Import Item No. 11 of<br>adhoc norms fixed by NC-3 against Advance Authorization<br>No. 0910056902 dated 25.07.2013 |
| **Decision:**The Committee considered the request of the firm in the presence of technical experts and it<br>was observed that the firm has not furnished any technical justification for enhancement of norms. Hence,<br>the Committee decided to reject the request of the firm maintaining the status quo. |
|
| Case No. |
A-17 |
| Meeting No. |
7/AM20 |
| Date |
24.09.2019 |
| Firm’s Name |
M/s Smilax Laboratories Limited, Hyderabad |
| HQ F. No. |
01/82/050/00842/AM16/DES-III |
| RLA F. No. |
09/24/040/00027/AM16 |
| Advance Authorization No. and Date |
0910062040 dated 19.05.2015 |
| Subject |
Request of M/s Smilax Laboratories Limited, Hyderabad<br>for enhancement in the quantity of Import Item Nos. 1, 3,<br>and 6 of adhoc norms fixed by NC-3 against Advance<br>Authorization No. 0910062040 dated 19.02.2015 |
| **Decision:**The Committee considered the request of the firm in the presence of technical experts and it<br>was observed that the firm has not furnished any technical justification for enhancement of norms. Hence,<br>the Committee decided to reject the request of the firm maintaining the status quo. |
|
| Case No. |
A-18 |
| Meeting No. |
7/AM20 |
| Date |
24.09.2019 |
| Firm’s Name |
M/s Zenith Dyeintermediates Ltd., Mumbai |
| HQ F. No. |
01/82/050/01571/AM19/DES-III |
| RLA F. No. |
03/95/040/00783/AM19 |
| Advance Authorization No. and Date |
0310824931 dated 06.11.2018 |
| Subject |
Request of M/s Zenith Dyeintermediates Ltd, Mumbai for<br>enhancement in the quantity of import item in respect of<br>adhoc norms fixed against Advance Authorization No.<br>0310824931 dated 06.11.2018 |
| Decision:The Committee considered the request of the firm for enhancement of norms in the presence<br>of technical experts and after taking cue from earlier decision of Meeting No. 14/82-ALC4/2018, dated<br>14.02.2019, it was decided to revise the norms of the quantity of import item -TOBIAS ACID<br>(PURITY MIN. 97%) from1.20 kgto1.618 kgunder para 4.7 of HBP Vol. I as per details or as applied by<br>firm whichever is lower.<br>Rest of the earlier Minutes would remain unchanged.<br>RA concerned may take appropriate action as per the decision of Norms Committee. |
|
133
| Case No. |
A-19 |
| Meeting No. |
7/AM20 |
| Date |
24.09.2019 |
| Firm’s Name |
M/s Saurav Chemicals Ltd, Chandigarh |
| HQ F. No. |
01/82/050/00372/AM18/DES-III |
| RLA F. No. |
22/24/040/00002/AM18 |
| Advance Authorization No. and Date |
2210015700 dated 05.05.2017 |
| Subject |
Request of M/s Saurav Chemicals Ltd, Chandigarh, for<br>revision/correction in adhoc norms fixed against Advance<br>Authorization No. 2210015700 dated 05.05.2017 |
| **Decision:**The Committee considered the request of the firm in the presence of technical experts and it was<br>decided to correct the description of Import Item No. 1 to read as “KETOPROFEN NITRILE”. |
|
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Case No. |
Case No. |
A-20 |
A-20 |
A-20 |
A-20 |
|
Meeting No. |
|
7/AM20 |
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Date |
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24.09.2019 |
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Firm’s Name |
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M/s Sanmar Speciality Chemicals Ltd., Chennai |
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HQ F. No. |
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01/82/050/00852/AM14/DES-III |
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RLA F. No. |
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04/24/040/00146/AM14 |
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Advance Authorization No. and Date |
|
0410150519 dated 03.10.2013 |
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Subject |
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Request of M/s Sanmar Speciality Chemicals Ltd., Chennai<br>for fixation of the input output norms fixed by NC-3 against<br>Advance Authorization No. 0410150519 dated 03.10.2013 |
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|
|
|
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to ratify the adhoc norms under para 4.7 of HBP Vol. I as per details below or as applied by<br>firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>4 CHLOROBUTYLVERATRATE<br>60% SOLUTION IN METHYL-<br>ETHYL-KETONE<br>1 kg<br>1<br>3, 4 DIMETHOXYBENZOIC<br>ACID<br>0.4728 kg<br>RA concerned may take further necessary action as per above decision of NC. |
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Export product |
Qty. |
|
Sl.<br>No. |
Import items |
Qty. |
|
4 CHLOROBUTYLVERATRATE<br>60% SOLUTION IN METHYL-<br>ETHYL-KETONE |
1 kg |
|
1 |
3, 4 DIMETHOXYBENZOIC<br>ACID |
0.4728 kg |
|
RA concerned may take further necessary action |
|
|
as per above decision of NC. |
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|
134
|
Case No. |
Case No. |
A-21 |
A-21 |
A-21 |
A-21 |
|
Meeting No. |
|
7/AM20 |
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|
Date |
|
24.09.2019 |
|
|
|
|
Firm’s Name |
|
M/s Scottish Chemical Industries, Mumbai |
|
|
|
|
HQ F. No. |
|
01/82/050/00336/AM19/DES-III |
|
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|
|
RLA F. No. |
|
03/95/040/00919/AM18 |
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|
|
Advance Authorization No. and Date |
|
0310819168 dated 15.02.2018 |
|
|
|
|
Subject |
|
Request of M/s Scottish Chemical Industries, Mumbai for<br>fixation of adhoc norms against Advance Authorization No.<br>0310819168 dated 15.02.2018 |
|
|
|
|
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it was<br>decided to ratify the adhoc norms under para 4.7 of HBP Vol. I as per details below or as applied by firm<br>whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>PERCHLOROETHYLENE<br>CATALYST GRADE PURIFIED<br>(Purity 99.99%)<br>1 kg<br>1<br>PERCHLOROETHYLENE<br>CATALYST GRADE<br>(Spent Purity 97%)<br>1 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
|
Export product |
Qty. |
|
Sl.<br>No. |
Import items |
Qty. |
|
PERCHLOROETHYLENE<br>CATALYST GRADE PURIFIED<br>(Purity 99.99%) |
1 kg |
|
1 |
PERCHLOROETHYLENE<br>CATALYST GRADE<br>(Spent Purity 97%) |
1 kg |
|
RA concerned may take further necessary action |
|
|
as per above decision of NC. |
|
|
| Case No. |
A-22 |
| Meeting No. |
7/AM20 |
| Date |
24.09.2019 |
| Firm’s Name |
M/s Hubergroup India Private Limited |
| HQ F. No. |
01/82/162/00954/AM19/DES-III |
| Subject |
Fixation of norms under para 4.06 of HBP Vol. I (2015-20) for<br>the export product Polyether Acrylate |
| **Decision:**The Committee considered the case as per agenda in the presence of technical experts and it was<br>decided to ratify the norms under para 4.06 of HBP Vol. I as per details below:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Polyether Acrylate<br>100 kg<br>1<br>Acrylic Acid<br>48.7 kg<br>2<br>MEHQ<br>0.22 kg<br>3<br>Para Toluene Sulfonic Acid<br>1.054 kg<br>4<br>Toluene<br>7.30 kg<br>5<br>Novalac Epoxy Resin<br>5.35 kg<br>6<br>Zirconium Octoate 22% (Xylene<br>base)<br>0.187 kg<br>7<br>Alkoxylated Polyalcohol<br>56.78 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
Meeting ended with thanks to Chair. *****
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