UDIN00181698AM22
Government of India Ministry of Commerce and Industry Department of Commerce
DIRECTORATE GENERAL OF FOREIGN TRADE
(DES - III SECTION)
MINUTES OF THE NORMS COMMITTEE- III
MEETING No. NC/3/MEET/Oct/202122/10 DATED: 12/11/2021
Please Note
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I. For information of exporters, Norms Committee - III handles all cases pertaining to fixation/ratification of norms for Export Products falling under ITC (HS) Chapter 29, 30. Communications in respect of cases/pertaining to NC- III may be sent to email address: nc3.dgft@nic.in
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II. The Norms Committee has taken decision only with respect to technical aspect/wastage norms. While redeeming the applications, RAs should check that the applicant has fulfilled all requirements as prescribed in policy/procedure including those in Policy Circulars issued from time to time or any other provisions under FTP/HBP for EODC.
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III. Wherever the Committee has fixed Norms, the concerned RA may ensure that AA is issued on the wastages/consumption as ratified by the Committee or as per wastages claimed in the application, whichever is less.
Minutes of the Norms Committee – 3 Meeting No. NC/3/MEET/Oct/202122/10 dated 12.11.2021, was actually held on 26.11.2021 under the Chairmanship of Dr. Amiya Chandra, Addl. DGFT 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.
Following members were present in the Meeting:
|
S.No. |
Name and Designation of Representatives |
Department |
| 1 |
|
AJAY KUMAR,Deputy Director |
Directorate General of Foreign Trade, Delhi |
| 2 |
|
SHAISH KUMAR,Technical Authority |
Technical Consultant,DGFT |
| 3 |
|
DINESHNARAIN MATHUR,Technical<br>Authority |
Technical Consultant,DGFT |
Case Details and Decision(s):
| Case No. |
1 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
This document has been digitally signed by Amiya Chandra, Additional DGFT on 09-12-2021 10:53:13.
UDIN00181698AM22
| Party Name |
ENCUBE ETHICALS PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205000622AM20 |
| RA File Number |
039404000395 AM20 |
| Licence No and<br>Date |
0310831546/13/09/2019 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of Master Batch Formula for Export Product No. 19, 22 and 23.<br>i. |
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| Case No. |
2 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
OC SPECIALITIES PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205000672AM20 |
| RA File Number |
039504000625 AM20 |
| Licence No and<br>Date |
0310831873/27/09/2019 |
| Norms Committee Decision:<br>The firm has furnished its reply on DGFT Back Office Portal. Deferred for comments of TE. |
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| Case No. |
3 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
PANACEA BIOTEC LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205000913AM20 |
| RA File Number |
052404000566 AM20 |
| Licence No and<br>Date |
0510412934/17/12/2019 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:<br> |
|
UDIN00181698AM22
| Sl. No.<br>Export product<br>Qty.<br>1<br>TACPAN 0.5 MG CAPSULES<br>(EACH HARD GELATIN CAPSULE CONTAINS: TACROLIMUS EQUIVALENT TO<br>ANHYDROUS TACROLIMUS...0.5 MG)<br>100 Capsules<br>2<br>TACPAN 1.0 MG CAPSULES<br>(EACH HARD GELATIN CAPSULE CONTAINS: TACROLIMUS EQUIVALENT TO<br>ANHYDROUS TACROLIMUS...1.0 MG)<br>100 Capsules<br>3<br>PANGRAF 1.0 MG CAPSULES<br>(EACH HARD GELATIN CAPSULE CONTAINS:TACROLIMUS EQUIVALENT TO<br>ANHYDROUSTACROLIMUS 1.0 MG)<br>100 Capsules<br>4<br>PANGRAF 0.5 MG CAPSULES<br>(EACH HARD GELATIN CAPSULE CONTAINS:TACROLIMUS EQUIVALENT TO<br>ANHYDROUS TACROLIMUS... 0.5 MG)<br>100 Capsules<br>5<br>PANOLIMUS CAPSULES 0.5 MG<br>(EACH HARD GELATIN CAPSULE CONTAINS: TACROLIMUS EQUIVALENT TO<br>ANHYDROUS TACROLIMUS....0.5 mg)<br>100 Capsules<br>6<br>PANOLIMUS CAPSULES 1.0 MG<br>(EACH HARD GELATIN CAPSULE CONTAINS: TACROLIMUS EQUIVALENT TO<br>ANHYDROUS TACROLIMUS....1.0mg)<br>100 Capsules<br>Qty.<br>Sl. No.<br>Import items<br>0.5 mg Capsule<br>1.0 mg Capsule<br>1<br>TACROLIMUS (water content 2.1% as per COA)<br>52.07 mg<br>104.142 mg<br>RA concerned may take further necessary action as per above decision of NC. |
Sl. No. |
Export product |
Export product |
Export product |
Export product |
Qty. |
|
1 |
TACPAN 0.5 MG CAPSULES<br>(EACH HARD GELATIN CAPSULE CONTAINS: TACROLIMUS EQUIVALENT TO<br>ANHYDROUS TACROLIMUS...0.5 MG) |
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<br>100 Capsules |
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2 |
TACPAN 1.0 MG CAPSULES<br>(EACH HARD GELATIN CAPSULE CONTAINS: TACROLIMUS EQUIVALENT TO<br>ANHYDROUS TACROLIMUS...1.0 MG) |
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<br>100 Capsules |
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3 |
PANGRAF 1.0 MG CAPSULES<br>(EACH HARD GELATIN CAPSULE CONTAINS:TACROLIMUS EQUIVALENT TO<br>ANHYDROUSTACROLIMUS 1.0 MG) |
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<br>100 Capsules |
|
4 |
PANGRAF 0.5 MG CAPSULES<br>(EACH HARD GELATIN CAPSULE CONTAINS:TACROLIMUS EQUIVALENT TO<br>ANHYDROUS TACROLIMUS... 0.5 MG) |
|
|
|
<br>100 Capsules |
|
5 |
PANOLIMUS CAPSULES 0.5 MG<br>(EACH HARD GELATIN CAPSULE CONTAINS: TACROLIMUS EQUIVALENT TO<br>ANHYDROUS TACROLIMUS....0.5 mg) |
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<br>100 Capsules |
|
6 |
PANOLIMUS CAPSULES 1.0 MG<br>(EACH HARD GELATIN CAPSULE CONTAINS: TACROLIMUS EQUIVALENT TO<br>ANHYDROUS TACROLIMUS....1.0mg) |
|
|
|
<br>100 Capsules |
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|
Sl. No. |
|
Import items |
Qty. |
|
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|
0.5 mg Capsule |
1.0 mg Capsule |
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|
1 |
|
TACROLIMUS (water content 2.1% as per COA) |
52.07 mg |
104.142 mg |
|
RA concerned may take further necessary action as per above decision of NC.
| Case No. |
4 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
PANACEA BIOTEC LIMITED |
UDIN00181698AM22
| Meeting Number<br>and Date |
Meeting Number<br>and Date |
Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
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018205000951AM20 |
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| RA File Number |
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052404000619 AM20 |
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| Licence No and<br>Date |
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0510413189/02/01/2020 |
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| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per |
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| <br>details given below o |
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<br>r as applied by the firm, whichever is less: |
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Sl. No. |
Export pr |
oduct |
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Qty. |
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1 |
TACPAN |
0.5 MG CAPSULES |
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100 Capsules |
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EACH<br>ANHYD |
HARD GELATIN CAPSULE CONTAINS TACROLIMUS EQUIVALENT TO<br>ROUS TACROLIMUS 0.5 MG |
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<br> |
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2 |
TACPAN 1.0 MG CAPSULES<br>EACH HARD GELATIN CAPSULE CONTAINS TACROLIMUS EQUIVALENT TO<br>ANHYDROUS TACROLIMUS 1.0 MG |
|
|
<br>100 Capsules |
|
3 |
TACPAN 5.0 MG CAPSULES<br>EACH HARD GELATIN CAPSULE CONTAINS TACROLIMUS EQUIVALENT TO<br>ANHYDROUS TACROLIMUS 5.0 MG |
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|
<br>100 Capsules |
|
4 |
PANGRAF 0.5 MG CAPSULES<br>EACH HARD GELATIN CAPSULE CONTAINS TACROLIMUS EQUIVALENT TO |
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|
<br>100 Capsules |
|
|
ANHYDROUS TACROLIMUS 0.5 MG |
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5 |
PANGRAF 1.0 MG CAPSULES<br>EACH<br>HARD<br>GELATIN<br>CAPSULE<br>CONTAINS:TACROLIMUS<br>EQUIVALENT<br>TO |
|
|
<br>100 Capsules |
|
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ANHYD |
ROUS TACROLIMUS 1.0 MG |
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6 |
PANOLI |
MUS CAPSULES 0.5 MG |
|
100 Capsules |
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EACH<br>ANHYD |
HARD GELATIN CAPSULE CONTAINS TACROLIMUS EQUIVALENT TO<br>ROUS TACROLIMUS 0.5 mg |
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7 |
PANOLI |
MUS CAPSULES 1.0 MG |
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EACH<br>ANHYD |
HARD GELATIN CAPSULE CONTAINS TACROLIMUS EQUIVALENT TO<br>ROUS TACROLIMUS 1.0 mg |
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Sl. No. |
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Import items |
Qty. |
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| Meeting Number<br>and Date |
Meeting Number<br>and Date |
Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
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018205000951AM20 |
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| RA File Number |
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052404000619 AM20 |
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| Licence No and<br>Date |
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|
0510413189/02/01/2020 |
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| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per |
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| <br>details given below o |
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<br>r as applied by the firm, whichever is less: |
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Sl. No. |
Export pr |
oduct |
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Qty. |
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1 |
TACPAN |
0.5 MG CAPSULES |
|
100 Capsules |
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EACH<br>ANHYD |
HARD GELATIN CAPSULE CONTAINS TACROLIMUS EQUIVALENT TO<br>ROUS TACROLIMUS 0.5 MG |
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<br> |
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2 |
TACPAN 1.0 MG CAPSULES<br>EACH HARD GELATIN CAPSULE CONTAINS TACROLIMUS EQUIVALENT TO<br>ANHYDROUS TACROLIMUS 1.0 MG |
|
|
<br>100 Capsules |
|
3 |
TACPAN 5.0 MG CAPSULES<br>EACH HARD GELATIN CAPSULE CONTAINS TACROLIMUS EQUIVALENT TO<br>ANHYDROUS TACROLIMUS 5.0 MG |
|
|
<br>100 Capsules |
|
4 |
PANGRAF 0.5 MG CAPSULES<br>EACH HARD GELATIN CAPSULE CONTAINS TACROLIMUS EQUIVALENT TO |
|
|
<br>100 Capsules |
|
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ANHYDROUS TACROLIMUS 0.5 MG |
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5 |
PANGRAF 1.0 MG CAPSULES<br>EACH<br>HARD<br>GELATIN<br>CAPSULE<br>CONTAINS:TACROLIMUS<br>EQUIVALENT<br>TO |
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|
<br>100 Capsules |
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ANHYD |
ROUS TACROLIMUS 1.0 MG |
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6 |
PANOLI |
MUS CAPSULES 0.5 MG |
|
100 Capsules |
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EACH<br>ANHYD |
HARD GELATIN CAPSULE CONTAINS TACROLIMUS EQUIVALENT TO<br>ROUS TACROLIMUS 0.5 mg |
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7 |
PANOLI |
MUS CAPSULES 1.0 MG |
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EACH<br>ANHYD |
HARD GELATIN CAPSULE CONTAINS TACROLIMUS EQUIVALENT TO<br>ROUS TACROLIMUS 1.0 mg |
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Sl. No. |
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Import items |
Qty. |
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UDIN00181698AM22
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0.5 mg Capsule |
1.0 mg Capsule |
| 1 |
TACROLIMUS (water content |
2.1% as per COA) |
52.07 mg |
104.142 mg |
| Case No. |
5 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
BALAJI AMINES LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001288AM21 |
| RA File Number |
318304000005 AM21 |
| Licence No and<br>Date |
3110067732/12/05/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting<br>No.NC/3MEET/Sep/202122/8 dated 24.09.2021against Advance Authorization No.3110067689 dated 19.02.2020, it<br>was decided to ratify adhoc norms under Para 4.07 of HBP vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>GAMMA BUTYROLACTONE<br>0.72 kg<br>N-ETHYL-2-PYRROLIDONE<br>1 kg<br>2<br>MONOETHYLAMINE 70% SOLUTION<br>0.533 kg<br>RA concerned may take further necessary action as per above decision of NC. |
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Case No. 6 / NC/3/MEET/Oct/202122/10
UDIN00181698AM22
| Case Status |
Case Deferred |
| Party Name |
ANLON HEALTHCARE PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001711AM21 |
| RA File Number |
242404000050 AM21 |
| Licence No and<br>Date |
2410043265/01/10/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i. |
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| Case No. |
Case No. |
7 / NC/3/MEET/Oct/202122/10 |
7 / NC/3/MEET/Oct/202122/10 |
7 / NC/3/MEET/Oct/202122/10 |
7 / NC/3/MEET/Oct/202122/10 |
7 / NC/3/MEET/Oct/202122/10 |
| Case Status |
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Case Approved |
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| Party Name |
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CADILA HEALTHCARE LIMITED |
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| Meeting Number and Date |
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NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
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| HQ File Number |
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018205001712AM21 |
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| RA File Number |
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082404000207 AM21 |
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| Licence No and Date |
|
0810148710/01/10/2020 |
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| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>CHOLECALCIFEROL<br>CONCENTRATE PH EUR (POWDER<br>FORM) (THIS LICENCE IS ISSUED<br>AS PER POLICY CIRCULAR NO. 9<br>DATED 30.06.2003 AND POLICY<br>CIRCULAR NO. 15 DATED 17.09.2003<br>AND AS PER PARA 4.07 OF HBP<br>2015-20 SUBLECT TO FIXATION OF<br>NORMS BY ALC, NEW DELHI)<br>4.08 mg<br>2<br>CALCIUM CARBONATE PH EUR<br>1275.00 mg<br>CALCIUM<br>VITAMIN<br>D3<br>CHEWABLE<br>TABLETS<br>500MG/400UI<br>(EACH TABLETS CONTAIN<br>4MG<br>CHOLECALCIFEROL<br>CONCENTRATE<br>PH<br>EUR<br>EQUIVALENT<br>TO<br>CHOLECALCIFEROL 400UI)<br>(ACTIVE<br>INGREDIENT:<br>CHOLECALCIFEROL<br>CONCENTRATE<br>PH<br>EUR<br>1 Number<br>Tablet |
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Export product |
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Qty. |
Sl. No. |
Import items |
Qty. |
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CALCIUM<br>VITAMIN<br>D3<br>CHEWABLE<br>TABLETS<br>500MG/400UI<br>(EACH TABLETS CONTAIN<br>4MG<br>CHOLECALCIFEROL<br>CONCENTRATE<br>PH<br>EUR<br>EQUIVALENT<br>TO<br>CHOLECALCIFEROL 400UI)<br>(ACTIVE<br>INGREDIENT:<br>CHOLECALCIFEROL<br>CONCENTRATE<br>PH<br>EUR |
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<br> <br> <br> <br> <br> <br> <br> <br> <br>1 Number<br>Tablet |
1 |
CHOLECALCIFEROL<br>CONCENTRATE PH EUR (POWDER<br>FORM) (THIS LICENCE IS ISSUED<br>AS PER POLICY CIRCULAR NO. 9<br>DATED 30.06.2003 AND POLICY<br>CIRCULAR NO. 15 DATED 17.09.2003<br>AND AS PER PARA 4.07 OF HBP<br>2015-20 SUBLECT TO FIXATION OF<br>NORMS BY ALC, NEW DELHI) |
<br> <br> <br> <br> <br> <br> <br>4.08 mg |
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2 |
CALCIUM CARBONATE PH EUR |
1275.00 mg |
UDIN00181698AM22
| (POWDER FORM) - NET WT. |
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3 |
SORBITOL PH |
EUR |
|
339.00 mg |
| 11.196 KGS.) |
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4 |
MAGNESIUM |
STEARATE |
PH |
<br>17.40 mg |
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EUR/NF |
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| Case No. |
Case No. |
8 / NC/3/MEET/Oct/202122/10 |
8 / NC/3/MEET/Oct/202122/10 |
8 / NC/3/MEET/Oct/202122/10 |
8 / NC/3/MEET/Oct/202122/10 |
8 / NC/3/MEET/Oct/202122/10 |
| Case Status |
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Case Approved |
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| Party Name |
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SATYADIVIS PHARMACEUTICALS PRIVATE LIMITED |
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| Meeting Number<br>and Date |
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NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
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| HQ File Number |
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018205001716AM21 |
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| RA File Number |
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092404000319 AM21 |
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| Licence No and<br>Date |
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0910069294/01/10/2020 |
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| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>BENZALDEHYDE<br>0.83 kg<br>2<br>PALLADIUM<br>0.005 kg<br>3<br>ACETOPHENONE<br>0.847 kg<br>4<br>DIMETHYL SULPHOXIDE<br>2.29 kg<br>5<br>PARAFORMALDEHYDE<br>0.253 kg<br>FLUOXETINE HCL<br>1 kg<br>6<br>PARA CHLORO BENZO TRIFLOURIDE<br>1.054 kg |
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Export product |
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Qty. |
Sl. No. |
Import items |
Qty. |
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FLUOXETINE HCL |
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1 kg |
1 |
BENZALDEHYDE |
0.83 kg |
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2 |
PALLADIUM |
0.005 kg |
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3 |
ACETOPHENONE |
0.847 kg |
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4 |
DIMETHYL SULPHOXIDE |
2.29 kg |
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5 |
PARAFORMALDEHYDE |
0.253 kg |
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6 |
PARA CHLORO BENZO TRIFLOURIDE |
1.054 kg |
UDIN00181698AM22
| Case No. |
9 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
RENOWN PHARMACEUTICALS PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001720AM21 |
| RA File Number |
342404000182 AM21 |
| Licence No and<br>Date |
3410046439/05/10/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>SOFT GELATIN CAPSULES ( ITC<br>(HS) CODE 30045090 / 30045039 )<br>(NET CONTENT : 1) GELATIN 175<br>BLOOM 5-15 MESH : 15622.800<br>KILOGRAM)<br>554,00,000<br>Numbers<br>1<br>GELATIN 175 BLOOM 5-15 MESH<br>16404 kg<br>RA concerned may take further necessary action as per above decision of NC. |
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| Case No. |
10 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
SRI CHEMICALS |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001728AM21 |
| RA File Number |
042404000109 AM21 |
| Licence No and |
0410167147/07/10/2020 |
UDIN00181698AM22
Date
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information from the firm:
i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E. Stoichiometric balance, molecular weight, percentage yield at every stage of reaction.
| Case No. |
11 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
DIVI'S LABORATORIES LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001733AM21 |
| RA File Number |
092404000328 AM21 |
| Licence No and<br>Date |
0910069310/08/10/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>N-FORMYL OCTABASE<br>1.55 kg<br>2<br>PHOSPHORUS PENTOXIDE<br>1.20 kg<br>3<br>TOLUENE<br>1.09 kg<br>4<br>METHANOL<br>0.824 kg<br>DEXTROMETHORPHAN<br>1 kg<br>5<br>ACETONE<br>0.420 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
UDIN00181698AM22
| Case No. |
12 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
SMILAX LABORATORIES LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001734AM21 |
| RA File Number |
092404000358 AM21 |
| Licence No and<br>Date |
0910069312/08/10/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i. |
|
| Case No. |
13 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
SRF LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001729AM21 |
| RA File Number |
052404000333 AM21 |
| Licence No and<br>Date |
0510415443/08/10/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i.<br>Stoichiometric balance, molecular weight, percentage yield at every stage of reaction.<br>ii. |
|
| Case No. |
14 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
SUPERMINT EXPORTS PRIVATE LIMITED |
UDIN00181698AM22
|
|
|
|
|
|
| Meeting Number<br> |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| and Date |
|
| HQ File Number |
018205001737AM21 |
|
|
| RA File Number |
052404000340 AM21 |
|
|
| Licence No and<br> |
0510415463/09/10/2020 |
| Date |
|
| Norms Committee |
Decision: |
| The Committee considered the case as per agenda and it was decided to call for following information from the firm: |
|
| Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i. |
|
| Case No. |
15 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
OPTRIX LABORATORIES PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001743AM21 |
| RA File Number |
092404000272 AM21 |
| Licence No and<br>Date |
0910069335/15/10/2020 |
| Norms Committee Decision: |
|
| The Committee considered the case as per agenda and it was decided to call for following information from the firm: |
|
| Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E. |
|
| Case No. |
16 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
OPTRIX LABORATORIES PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001744AM21 |
| RA File Number |
092404000273 AM21 |
| Licence No and<br>Date |
0910069336/15/10/2020 |
| Norms Committee Decision: |
|
UDIN00181698AM22
Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.
| Case No. |
Case No. |
17 / NC/3/MEET/Oct/202122/10 |
17 / NC/3/MEET/Oct/202122/10 |
17 / NC/3/MEET/Oct/202122/10 |
17 / NC/3/MEET/Oct/202122/10 |
17 / NC/3/MEET/Oct/202122/10 |
| Case Status |
|
Case Approved |
|
|
|
|
| Party Name |
|
AURORE LIFE SCIENCES PRIVATE LIMITED |
|
|
|
|
| Meeting Number<br>and Date |
|
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
|
|
|
|
| HQ File Number |
|
018205001761AM21 |
|
|
|
|
| RA File Number |
|
092404000382 AM21 |
|
|
|
|
| Licence No and<br>Date |
|
0910069343/19/10/2020 |
|
|
|
|
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl-4-chloro Aceto Acetate<br>0.993 kg<br>2<br>Ortho Chloro Benzaldehyde<br>0.775 kg<br>3<br>Methyl Aceto Acetate<br>1.460 kg<br>4<br>Toluene<br>2.40 kg<br>Amlodipine Base<br>1 kg<br>5<br>Methanol<br>1.25 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl. No. |
Import items |
Qty. |
|
Amlodipine Base |
|
1 kg |
1 |
Ethyl-4-chloro Aceto Acetate |
0.993 kg |
|
|
|
|
2 |
Ortho Chloro Benzaldehyde |
0.775 kg |
|
|
|
|
3 |
Methyl Aceto Acetate |
1.460 kg |
|
|
|
|
4 |
Toluene |
2.40 kg |
|
|
|
|
5 |
Methanol |
1.25 kg |
|
|
|
|
s per above decision of NC. |
|
|
UDIN00181698AM22
| Case No. |
Case No. |
18 / NC/3/MEET/Oct/202122/10 |
18 / NC/3/MEET/Oct/202122/10 |
18 / NC/3/MEET/Oct/202122/10 |
18 / NC/3/MEET/Oct/202122/10 |
18 / NC/3/MEET/Oct/202122/10 |
| Case Status |
|
Case Approved |
|
|
|
|
| Party Name |
|
AURORE LIFE SCIENCES PRIVATE LIMITED |
|
|
|
|
| Meeting Number<br>and Date |
|
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
|
|
|
|
| HQ File Number |
|
018205001762AM21 |
|
|
|
|
| RA File Number |
|
092404000383 AM21 |
|
|
|
|
| Licence No and<br>Date |
|
0910069344/19/10/2020 |
|
|
|
|
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl-4-chloro Aceto Acetate<br>0.993 kg<br>2<br>Ortho Chloro Benzaldehyde<br>0.775 kg<br>3<br>Methyl Aceto Acetate<br>1.460 kg<br>4<br>Toluene<br>2.40 kg<br>Amlodipine Base<br>1 kg<br>5<br>Methanol<br>1.25 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl. No. |
Import items |
Qty. |
|
Amlodipine Base |
|
1 kg |
1 |
Ethyl-4-chloro Aceto Acetate |
0.993 kg |
|
|
|
|
2 |
Ortho Chloro Benzaldehyde |
0.775 kg |
|
|
|
|
3 |
Methyl Aceto Acetate |
1.460 kg |
|
|
|
|
4 |
Toluene |
2.40 kg |
|
|
|
|
5 |
Methanol |
1.25 kg |
|
|
|
|
s per above decision of NC. |
|
|
| Case No.<br> |
19 / NC/3/MEET/Oct/202122/10 |
| Case Status<br> |
Case Approved |
| Party Name<br> |
AURORE LIFE SCIENCES PRIVATE LIMITED |
| Meeting Number<br>and Date<br> |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number<br> |
018205001763AM21 |
| RA File Number<br> |
092404000381 AM21 |
| Licence No and<br>Date<br> |
0910069345/19/10/2020 |
UDIN00181698AM22
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:
| Export product |
Qty. |
Sl. No. |
Import items |
Qty. |
| Pinaverium Bromide |
1 kg |
1 |
Dihydro Nopol |
0.60 kg |
| Case No. |
20 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
STERILE INDIA PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001768AM21 |
| RA File Number |
052404000355 AM21 |
| Licence No and<br>Date |
0510415575/20/10/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i. |
|
| Case No. |
21 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
JODAS EXPOIM PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001773AM21 |
| RA File Number |
092404000356 AM21 |
| Licence No and<br>Date |
0910069364/22/10/2020 |
UDIN00181698AM22
Norms Committee Decision:
(i) Stepwise chemical reactions, molecular weight and percentage yield on molar basis for conversion of ATIPA.cl to Iopromide.
Copy of DML for each export item showing approved composition.
| Case No. |
Case No. |
22 / NC/3/MEET/Oct/202122/10 |
22 / NC/3/MEET/Oct/202122/10 |
22 / NC/3/MEET/Oct/202122/10 |
22 / NC/3/MEET/Oct/202122/10 |
22 / NC/3/MEET/Oct/202122/10 |
| Case Status |
|
Case Approved |
|
|
|
|
| Party Name |
|
AURORE LIFE SCIENCES PRIVATE LIMITED |
|
|
|
|
| Meeting Number<br>and Date |
|
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
|
|
|
|
| HQ File Number |
|
018205001774AM21 |
|
|
|
|
| RA File Number |
|
092404000365 AM21 |
|
|
|
|
| Licence No and<br>Date |
|
0910069368/22/10/2020 |
|
|
|
|
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>2,2,2-Trifluoroethanol<br>1.014 kg<br>2<br>Dimethyl formamide<br>1.50 kg<br>3<br>Toluene<br>1.00 kg<br>4<br>Acetic Acid<br>0.61 kg<br>5<br>Sodium Nitrite<br>1.05 kg<br>2,5-Bis-(2,2,2-Trifluoroethoxy) Benzoic Acid<br>1 kg<br>6<br>Hydrogen Peroxide<br>0.70 kg |
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl. No. |
Import items |
Qty. |
|
2,5-Bis-(2,2,2-Trifluoroethoxy) Benzoic Acid |
|
1 kg |
1 |
2,2,2-Trifluoroethanol |
1.014 kg |
|
|
|
|
2 |
Dimethyl formamide |
1.50 kg |
|
|
|
|
3 |
Toluene |
1.00 kg |
|
|
|
|
4 |
Acetic Acid |
0.61 kg |
|
|
|
|
5 |
Sodium Nitrite |
1.05 kg |
|
|
|
|
6 |
Hydrogen Peroxide |
0.70 kg |
|
|
|
|
|
|
|
UDIN00181698AM22
| Case No. |
Case No. |
23 / NC/3/MEET/Oct/202122/10 |
23 / NC/3/MEET/Oct/202122/10 |
23 / NC/3/MEET/Oct/202122/10 |
23 / NC/3/MEET/Oct/202122/10 |
23 / NC/3/MEET/Oct/202122/10 |
| Case Status |
|
Case Approved |
|
|
|
|
| Party Name |
|
AURORE LIFE SCIENCES PRIVATE LIMITED |
|
|
|
|
| Meeting Number<br>and Date |
|
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
|
|
|
|
| HQ File Number |
|
018205001775AM21 |
|
|
|
|
| RA File Number |
|
092404000384 AM21 |
|
|
|
|
| Licence No and<br>Date |
|
0910069369/22/10/2020 |
|
|
|
|
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Resorcinol<br>1.77 kg<br>2<br>Methyl Aceto Acetate<br>1.86 kg<br>2,6-Dihydroxy Acetophenone<br>1 kg<br>3<br>Toluene<br>1.32 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl. No. |
Import items |
Qty. |
|
2,6-Dihydroxy Acetophenone |
|
1 kg |
1 |
Resorcinol |
1.77 kg |
|
|
|
|
2 |
Methyl Aceto Acetate |
1.86 kg |
|
|
|
|
3 |
Toluene |
1.32 kg |
|
|
|
|
s per above decision of NC. |
|
|
| Case No. |
24 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
AURORE LIFE SCIENCES PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001780AM21 |
| RA File Number |
092404000407 AM21 |
| Licence No and |
0910069374/23/10/2020 |
UDIN00181698AM22
Date
Norms Committee Decision:
i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.
| Case No. |
25 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
AURORE LIFE SCIENCES PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001781AM21 |
| RA File Number |
092404000408 AM21 |
| Licence No and<br>Date |
0910069377/23/10/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i. |
|
| Case No. |
26 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
MAKCUR LABORATORIES LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001782AM21 |
| RA File Number |
082404000249 AM21 |
| Licence No and<br>Date |
0810148893/26/10/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i. |
|
UDIN00181698AM22
| Case No. |
27 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
LACTOSE (INDIA) LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001785AM21 |
| RA File Number |
039504000472 AM21 |
| Licence No and<br>Date |
0310839161/27/10/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3MEET/Aug/202122/7 dated 13.08.2021against Advance Authorization No.0310830184 dated<br>09.07.2019, it was decided to ratify adhoc norms under Para 4.07 of HBP vol. I as per details given below or as<br>applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>LACTULOSE<br>CONCENTRATE<br>USP/EP/LACTULOSE SOLUTION<br>USP/ JP/ EP/ LACTULOSE FOOD<br>GRADE<br>160 MT<br>1<br>Food Grade Lactose/ Edible Grade Lactose/<br>Refined Edible Grade lactose / lactose<br>Monohydrate BP/EP/USP-NF<br>160 MT<br>RA concerned may take further necessary action as per above decision of NC. |
|
| Case No. |
28 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
AUROBINDO PHARMA LTD |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001786AM21 |
| RA File Number |
092404000337 AM21 |
| Licence No and<br>Date |
0910069393/27/10/2020 |
UDIN00181698AM22
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:
| Sl. No. |
Export product |
Qty. |
Sl. No. |
Import items |
Qty. |
| 1 |
Penicillin<br>V<br>Potassium<br>500mg Tablets (Each Tablet<br>contains 500mg Pencillin V<br>Potassium) |
<br> <br> <br>34000000.000<br>Number |
1 |
Phenoxymethyl Penicillin Potassium<br>(Penicillin V Potassium)<br>THIS LICENCE IS ISSUED WITH<br>PRIOR IMPORT CONDITON AND<br>THE E.O. SHOULD BE COMPLETED<br>WITHIN 12 MONTHS FROM THE<br>DATE<br>OF<br>EACH<br>IMPORT<br>CONSIGNMENT AS PER APPX.4J OF<br>FTP 2015-20, read with PN.No.62,<br>dt.24.03.2017 |
<br> <br> <br> <br> <br> <br> <br>17340.00 kg |
| 2 |
Penicillin<br>V<br>Potassium<br>250mg Tablets (Each Tablet<br>contains 250mg Penicillin V<br>Potassium) |
<br> <br> <br>5000000.000<br>Number |
1 |
Phenoxymethyl Penicillin Potassium<br>(Penicillin V Potassium)<br>THIS LICENCE IS ISSUED WITH<br>PRIOR IMPORT CONDITON AND<br>THE E.O. SHOULD BE COMPLETED<br>WITHIN 12 MONTHS FROM THE<br>DATE<br>OF<br>EACH<br>IMPORT<br>CONSIGNMENT AS PER APPX.4J OF<br>FTP 2015-20, read with PN.No.62,<br>dt.24.03.2017 |
<br> <br> <br> <br> <br> <br> <br>1275.00 kg |
| Case No. |
29 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
R.L.FINE CHEM PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001787AM21 |
| RA File Number |
072404000209 AM21 |
| Licence No and<br>Date |
0710117187/27/10/2020 |
| Norms Committee Decision: |
|
UDIN00181698AM22
i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.
| Case No. |
30 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
SHIRDI CHEMICALS PRIVATE LIMITED |
| Meeting Number and<br>Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001784AM21 |
| RA File Number |
039504000469 AM21 |
| Licence No and Date |
0310839149/27/10/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting<br>No.NC/3MEET/Oct/202122/9 dated 15.10.2021against Advance Authorization No.0310834190 dated 15.01.2020, it<br>was decided to ratify adhoc norms under Para 4.07 of HBP vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ortho Cresol Cas No. 95-48-7<br>1.05 kg<br>2<br>3-Mercaptopropionic Acid Minimum 99%<br>0.025 kg<br>DMBPC OR 4,4-Cyclohexylidene<br>bis<br>2-methylphenol<br>OR<br>Dimethylbisphenolcyclohexane<br>(DMBPC)<br>1 kg<br>3<br>Dodecyl Benzene Sulphonic Acid Minimum<br>94%<br>0.065 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
Case No. 31 / NC/3/MEET/Oct/202122/10
UDIN00181698AM22
| Case Status |
Case Status |
Case Approved |
Case Approved |
Case Approved |
Case Approved |
Case Approved |
Case Approved |
Case Approved |
Case Approved |
Case Approved |
| Party Name |
|
SATYADEVA PHARMACEUTICALS PRIVATE LIMITED |
|
|
|
|
|
|
|
|
| Meeting Number<br>and Date |
|
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
|
|
|
|
|
|
|
|
| HQ File Number |
|
018205001798AM21 |
|
|
|
|
|
|
|
|
| RA File Number |
|
092404000429 AM21 |
|
|
|
|
|
|
|
|
| Licence No and<br>Date |
|
0910069398/28/10/2020 |
|
|
|
|
|
|
|
|
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>2-Thiophene ethanol<br>0.48 kg<br>ClopidogrelHSO4 (CBI) I<br>1 kg<br>2<br>Para-Toluene sulfonyl chloride (PTSC)<br>0.71 kg |
|
|
|
|
|
|
|
|
|
|
|
<br> |
|
|
|
|
|
|
|
|
|
|
Export product |
|
Qty. |
|
Sl. No. |
Impo |
rt items |
|
|
Qty. |
|
ClopidogrelHSO4 (CBI) I |
|
1 kg |
|
1 |
2-Th |
iophene |
ethanol |
|
0.48 kg |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2 |
Para-Toluene sulfonyl chloride (PTSC) |
|
|
|
0.71 kg |
|
|
|
|
|
|
|
|
|
|
|
| RA concerned may take further necessary action a |
|
|
|
|
s per above decision of NC. |
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|
|
| Case No. |
32 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
ALEOR DERMACEUTICALS LIMITED |
| Meeting Number |
|
| and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001801AM21 |
| RA File Number |
342404000205 AM21 |
| Licence No and<br>Date |
3410046497/28/10/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i. |
|
|
|
UDIN00181698AM22
| Case No. |
33 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
RAJASTHAN ANTIBIOTICS LTD |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001794AM21 |
| RA File Number |
052404000385 AM21 |
| Licence No and<br>Date |
0510415685/28/10/2020 |
| Norms Committee Decision: |
|
| The Committee considered the case as per agenda and it was decided to call for following information from the firm: |
|
| Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i. |
|
| Case No. |
Case No. |
34 / NC/3/MEET/Oct/202122/10 |
|
|
| Case Status |
|
Case Approved |
|
|
| Party Name |
|
AUROBINDO PHARMA LTD |
|
|
| Meeting Number<br>and Date |
|
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
|
|
| HQ File Number |
|
018205001795AM21 |
|
|
| RA File Number |
|
092404000372 AM21 |
|
|
| Licence No and<br>Date |
|
0910069400/28/10/2020 |
|
|
| Norms Committee Decision: |
|
|
|
|
| The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP |
|
|
|
|
| Vol. I as per details given below or as applied by the firm, whichever is less:<br> |
|
|
|
|
|
Export product |
Qty.<br>Sl. No. Import items |
Qty. |
|
|
1<br>(R)-3-Amino-1-butanol (or) (R)-3-Amino-butan-1-ol<br>DOLUTEGRAVIR<br>1 kg |
|
0.385 kg |
|
|
|
2<br>2,2-Dimethoxyethylamine |
0.635 kg |
|
|
|
3<br>2,4 -Difluoro benzylamine |
0.470 kg |
|
| Case No. |
Case No. |
34 / NC/3/MEET/Oct/202122/10 |
|
|
| Case Status |
|
Case Approved |
|
|
| Party Name |
|
AUROBINDO PHARMA LTD |
|
|
| Meeting Number<br>and Date |
|
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
|
|
| HQ File Number |
|
018205001795AM21 |
|
|
| RA File Number |
|
092404000372 AM21 |
|
|
| Licence No and<br>Date |
|
0910069400/28/10/2020 |
|
|
| Norms Committee Decision: |
|
|
|
|
| The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP |
|
|
|
|
| Vol. I as per details given below or as applied by the firm, whichever is less:<br> |
|
|
|
|
|
Export product |
Qty.<br>Sl. No. Import items |
Qty. |
|
|
1<br>(R)-3-Amino-1-butanol (or) (R)-3-Amino-butan-1-ol<br>DOLUTEGRAVIR<br>1 kg |
|
0.385 kg |
|
|
|
2<br>2,2-Dimethoxyethylamine |
0.635 kg |
|
|
|
3<br>2,4 -Difluoro benzylamine |
0.470 kg |
|
UDIN00181698AM22
| 4<br>Acetonitrile<br>1.570 kg<br>5<br>Activated Carbon (Carbon Enoanticromos)<br>0.050 kg<br>6<br>Dimethyl Oxalate<br>1.638 kg<br>7<br>Isopropyl Alcohol<br>1.710 kg<br>8<br>Lithiumhydroxide Monohydrate<br>0.264 kg<br>9<br>Methanesulfonic Acid<br>0.118 kg<br>10<br>Methanol (Methyl Alcohol)<br>2.63 kg<br>11<br>Methyl 4-Chloroacetoacetate (or) Methyl 4-Chloro-3-<br>Oxo-Butanoate<br>1.00 kg<br>12<br>Methylene Chloride<br>3.29 kg<br>13<br>N,N-Dimethyl Formamide Dimethyl Acetal<br>0.750 kg<br>14<br>Pivaloyl Chloride<br>0.380 kg<br>15<br>Tetrahydrofuran<br>1.70 kg<br>16<br>Triethylamine<br>0.367 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
4 |
Acetonitrile |
1.570 kg |
|
|
|
5 |
Activated Carbon (Carbon Enoanticromos) |
0.050 kg |
|
|
|
6 |
Dimethyl Oxalate |
1.638 kg |
|
|
|
7 |
Isopropyl Alcohol |
1.710 kg |
|
|
|
8 |
Lithiumhydroxide Monohydrate |
0.264 kg |
|
|
|
9 |
Methanesulfonic Acid |
0.118 kg |
|
|
|
10 |
Methanol (Methyl Alcohol) |
2.63 kg |
|
|
|
11 |
Methyl 4-Chloroacetoacetate (or) Methyl 4-Chloro-3-<br>Oxo-Butanoate |
1.00 kg |
|
|
|
12 |
Methylene Chloride |
3.29 kg |
|
|
|
13 |
N,N-Dimethyl Formamide Dimethyl Acetal |
0.750 kg |
|
|
|
14 |
Pivaloyl Chloride |
0.380 kg |
|
|
|
15 |
Tetrahydrofuran |
1.70 kg |
|
|
|
16 |
Triethylamine |
0.367 kg |
| Case No. |
35 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
SUVEN PHARMACEUTICALS LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001799AM21 |
UDIN00181698AM22
| RA File Number |
092404000430 AM21 |
| Licence No and<br>Date |
0910069403/29/10/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Technical Literature in support of low yields at all steps.<br>i.<br>Production / Consumption data duly certified by GST.<br>ii. |
|
| Case No. |
Case No. |
36 / NC/3/MEET/Oct/202122/10 |
36 / NC/3/MEET/Oct/202122/10 |
36 / NC/3/MEET/Oct/202122/10 |
36 / NC/3/MEET/Oct/202122/10 |
36 / NC/3/MEET/Oct/202122/10 |
| Case Status |
|
Case Approved |
|
|
|
|
| Party Name |
|
BALAJI AMINES LIMITED |
|
|
|
|
| Meeting Number<br>and Date |
|
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
|
|
|
|
| HQ File Number |
|
018205001800AM21 |
|
|
|
|
| RA File Number |
|
318304000089 AM21 |
|
|
|
|
| Licence No and<br>Date |
|
3110067907/29/10/2020 |
|
|
|
|
| Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting<br>No.NC/3MEET/Sep/202122/8 dated 24.09.2021against Advance Authorization No.3110067689 dated 19.02.2020, it<br>was decided to ratify adhoc norms under Para 4.07 of HBP vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>GAMMA BUTYROLACTONE<br>0.72 kg<br>N-ETHYL-2-PYRROLIDONE<br>1 kg<br>2<br>MONOETHYLAMINE 70% SOLUTION<br>0.533 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl. No. |
Import items |
Qty. |
|
N-ETHYL-2-PYRROLIDONE |
|
1 kg |
1 |
GAMMA BUTYROLACTONE |
0.72 kg |
|
|
|
|
2 |
MONOETHYLAMINE 70% SOLUTION |
0.533 kg |
|
|
|
|
as per above decision of NC. |
|
|
Case No. 37 / NC/3/MEET/Oct/202122/10
UDIN00181698AM22
| Case Status |
Case Deferred |
| Party Name |
LACTOSE (INDIA) LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001792AM21 |
| RA File Number |
039504000462 AM21 |
| Licence No and<br>Date |
0310839208/29/10/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Detailed specification and COA of import item – GALACTO FRUCTOSE.<br>i. |
|
| Case No. |
38 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
INCHEM LABORATORIES PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001803AM21 |
| RA File Number |
092404000371 AM21 |
| Licence No and<br>Date |
0910069415/29/10/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>(RS)-4-(2-AMINO-1-HYDROXY ETHYL) PHENOL<br>HCL CAS NO:770-05-8<br>0.446 kg<br>RACTOPAMINE HCL<br>1 kg<br>2<br>4(4-HYDROXY<br>PHENYL)2-BUTANONE<br>CAS<br>NO:5471-51-2<br>0.70 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
UDIN00181698AM22
| Case No. |
39 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
OPTIMUS DRUGS PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001804AM21 |
| RA File Number |
092404000388 AM21 |
| Licence No and<br>Date |
0910069417/29/10/2020 |
| Norms Committee Decision: |
|
| The Committee considered the case as per agenda and it was decided to call for following information from the firm: |
|
| Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i. |
|
| Case No. |
Case No. |
40 / NC/3/MEET/Oct/202122/10 |
|
|
| Case Status |
|
Case Approved |
|
|
| Party Name |
|
NEULAND LABORATORIES LTD. |
|
|
| Meeting Number<br>and Date |
|
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
|
|
| HQ File Number |
|
018205001796AM21 |
|
|
| RA File Number |
|
092404000413 AM21 |
|
|
| Licence No and<br>Date |
|
0910069406/29/10/2020 |
|
|
| Norms Committee Decision: |
|
|
|
|
| The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP |
|
|
|
|
| Vol. I as per details given below or as applied by the firm, whichever is less:<br> |
|
|
|
|
|
Export product |
Qty.<br>Sl. No. Import items |
Qty. |
|
|
1<br>Ethyl isobutyrate<br>Bempedoic Acid<br>1 kg |
|
1.78 kg |
|
|
|
2<br>1-Bromo-5-chloropentane |
2.45 kg |
|
UDIN00181698AM22
3 Toluenesulfonylmethyl isocyanide 0.90 kg RA concerned may take further necessary action as per above decision of NC.
| Case No. |
41 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
OPTIMUS DRUGS PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001805AM21 |
| RA File Number |
092404000389 AM21 |
| Licence No and<br>Date |
0910069418/29/10/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i. |
|
|
|
| Case No. |
42 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| P N |
HETERO DRUGS LIMITED |
| arty ame |
|
| Mti Nb |
|
| eeng umer<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
|
|
| HQ File Number |
018205001797AM21 |
|
|
| RA File Number |
092404000417 AM21 |
| Li N d |
|
| cence o an<br>Date |
0910069407/29/10/2020 |
|
|
| Norms Committee |
Decision: |
| <br>The Committee co |
<br>nsidered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP |
| Vol. I as per details given below or as applied by the firm, whichever is less:<br> |
|
|
|
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:
UDIN00181698AM22
| Export product |
Qty. |
Sl. No. Import items |
Qty. |
| Imeglimin HCl |
1 kg |
1<br>Metformin Hydrochloride |
2.94 kg |
| Case No. |
Case No. |
43 / NC/3/MEET/Oct/202122/10 |
43 / NC/3/MEET/Oct/202122/10 |
43 / NC/3/MEET/Oct/202122/10 |
43 / NC/3/MEET/Oct/202122/10 |
43 / NC/3/MEET/Oct/202122/10 |
| Case Status |
|
Case Approved |
|
|
|
|
| Party Name |
|
SRIAM LABS PRIVATE LIMITED |
|
|
|
|
| Meeting Number<br>and Date |
|
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
|
|
|
|
| HQ File Number |
|
018205001809AM21 |
|
|
|
|
| RA File Number |
|
092404000432 AM21 |
|
|
|
|
| Licence No and<br>Date |
|
0910069426/02/11/2020 |
|
|
|
|
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>2-Azabicylo [2.2.1] hept-5-en-3-one (Vince<br>lactam)<br>1.00 kg<br>Methyl (1S,4R)-4-aminocyclopent-2-<br>ene-1-carboxylate L(+)-Tartrate salt<br>(CAP-I)<br>1 kg<br>2<br>L(+) Tartaric acid<br>0.50 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl. No. |
Import items |
Qty. |
|
Methyl (1S,4R)-4-aminocyclopent-2-<br>ene-1-carboxylate L(+)-Tartrate salt<br>(CAP-I) |
|
<br> <br>1 kg |
1 |
2-Azabicylo [2.2.1] hept-5-en-3-one (Vince<br>lactam) |
<br>1.00 kg |
|
|
|
|
2 |
L(+) Tartaric acid |
0.50 kg |
|
|
|
|
s per above decision of NC. |
|
|
| Case No. |
44 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
ENCUBE ETHICALS PRIVATE LIMITED |
UDIN00181698AM22
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001811AM21 |
| RA File Number |
039404000500 AM21 |
| Licence No and<br>Date |
0310839257/02/11/2020 |
| Norms Committee Decision: |
|
| The Committee considered the case as per agenda and it was decided to call for following information from the firm: |
|
| Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i. |
|
| Meeting Number<br>and Date |
Meeting Number<br>and Date |
Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
|
|
018205001811AM21 |
|
|
|
|
| RA File Number |
|
|
039404000500 AM21 |
|
|
|
|
| Licence No and<br>Date |
|
|
0310839257/02/11/2020 |
|
|
|
|
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Copy of 4.0<br>i. |
|
|
7 application having complete technical details as per Annexure to Appendix 4E. |
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Case No. |
|
|
45 / NC/3/MEET/Oct/202122/10 |
|
|
|
|
|
|
|
|
|
|
|
|
| Case Status |
|
|
Case Approved |
|
|
|
|
| Party Name |
|
|
GLAND PHARMA LIMITED |
|
|
|
|
| Meeting Number<br>and Date |
|
|
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
|
|
|
|
| HQ File Number |
|
|
018205001808AM21 |
|
|
|
|
| RA File Number |
|
|
092404000428 AM21 |
|
|
|
|
| Licence No and<br>Date |
|
|
0910069419/02/11/2020 |
|
|
|
|
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP |
|
|
|
|
|
|
|
| Vol. I as per details given below or as applied by the firm, whichever is less:<br> |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sl. No. |
Export p |
roduct |
Qty. |
Sl. No. |
Import items |
Qty. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1 |
Milrinon |
e Lactate in 5% Dextrose |
<br>1 Number |
1 |
Milrinone |
21.00 mg |
|
|
Injection<br>Infusion |
<br>20mg/100ml,<br>100ml<br>Bag |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2 |
Twist off Port Stoppers |
Relevant<br>as<br>per<br>ki li |
|
|
|
|
|
|
|
pacng pocy |
|
2 |
Milrinon |
e Lactate in 5% Dextrose |
<br>1 Number |
1 |
Milrinone |
42.00 mg |
|
|
Injection<br>40mg/200ml,<br>200ml<br>Infusion Bag |
|
|
|
|
|
|
|
|
|
|
2 |
Twist off Port Stoppers |
Relevant<br>as<br>per<br>packing policy |
|
|
|
|
|
|
|
|
UDIN00181698AM22
| Case No. |
Case No. |
Case No. |
46 / NC/3/MEET/Oct/202122/10 |
46 / NC/3/MEET/Oct/202122/10 |
46 / NC/3/MEET/Oct/202122/10 |
46 / NC/3/MEET/Oct/202122/10 |
46 / NC/3/MEET/Oct/202122/10 |
| Case Status |
|
|
Case Approved |
|
|
|
|
| Party Name |
|
|
ADCOCK INGRAM LIMITED |
|
|
|
|
| Meeting Number<br>and Date |
|
|
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
|
|
|
|
| HQ File Number |
|
|
018205001812AM21 |
|
|
|
|
| RA File Number |
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072404000218 AM21 |
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| Licence No and<br>Date |
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0710117218/03/11/2020 |
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| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>COLOUR YELLOW 14037<br>IH<br>1.632 kg<br>1<br>SYNDOL<br>TABLETS<br>-<br>(Paracetamol 450mg + Caffeine<br>30mg + Doxylamine Succinate 5mg<br>+ Codeine Phosphate 10mg Colour<br>Yellow 14037-1.632mg) (Para -<br>6750.000+Caff -450.000+ Doxy-<br>75.000+Codeine - 150.000 Colour<br>Yellow 14037-24.480 KGS) (No.<br>of<br>Tablets<br>15000000)<br>BP/EP/USP/PH.EUR)<br>1 Million<br>Tablets<br>4<br>CODIENE<br>PHOSPHATE<br>BP / EP / USP / PH.EUR<br>10.2 kg<br>2<br>COLOUR<br>QUINOLINE<br>YELLOW<br>WS<br>(SPECTRACOL)<br>2.43 kg<br>3<br>COLOUR<br>QUINOLINE<br>YELLOW<br>LAKE<br>IH<br>(SPECTRACOL)<br>4.56 kg<br>ADCO<br>DOL<br>TABLETS<br>-<br>(Paracetamol<br>450mg+Codeine<br>Phosphate<br>10mg<br>+Caffeine<br>45mg+Doxylamine<br>Succinate<br>5mg+Colour<br>Yellow<br>Lake-<br>4.56mg+<br>Colour<br>Yellow<br>WS-<br>2.43mg)<br>(Para-<br>42750.000+<br>Codeine-<br>950.000<br>+<br>Caff-<br>4275.000+Doxy-475.000<br>Colour<br>Yellow<br>Lake-433.200<br>Colour<br>CODIENE<br>PHOSPHATE<br>2<br>1 Million<br>Tablets<br>4<br>10.2 kg |
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Sl. No. |
Export product |
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Qty. |
Sl. No. |
Import items |
Qty. |
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1 |
SYNDOL<br>TABLETS<br>-<br>(Paracetamol 450mg + Caffeine<br>30mg + Doxylamine Succinate 5mg<br>+ Codeine Phosphate 10mg Colour<br>Yellow 14037-1.632mg) (Para -<br>6750.000+Caff -450.000+ Doxy-<br>75.000+Codeine - 150.000 Colour<br>Yellow 14037-24.480 KGS) (No.<br>of<br>Tablets<br>15000000)<br>BP/EP/USP/PH.EUR) |
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<br> <br> <br> <br> <br> <br> <br> <br>1 Million<br>Tablets |
1 |
COLOUR YELLOW 14037<br>IH |
<br>1.632 kg |
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4 |
CODIENE<br>PHOSPHATE<br>BP / EP / USP / PH.EUR |
<br>10.2 kg |
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2 |
ADCO<br>DOL<br>TABLETS<br>-<br>(Paracetamol<br>450mg+Codeine<br>Phosphate<br>10mg<br>+Caffeine<br>45mg+Doxylamine<br>Succinate<br>5mg+Colour<br>Yellow<br>Lake-<br>4.56mg+<br>Colour<br>Yellow<br>WS-<br>2.43mg)<br>(Para-<br>42750.000+<br>Codeine-<br>950.000<br>+<br>Caff-<br>4275.000+Doxy-475.000<br>Colour<br>Yellow<br>Lake-433.200<br>Colour |
|
<br> <br> <br> <br> <br> <br>1 Million<br>Tablets |
2 |
COLOUR<br>QUINOLINE<br>YELLOW<br>WS<br>(SPECTRACOL) |
<br> <br>2.43 kg |
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3 |
COLOUR<br>QUINOLINE<br>YELLOW<br>LAKE<br>IH<br>(SPECTRACOL) |
<br> <br>4.56 kg |
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4 |
CODIENE<br>PHOSPHATE |
<br>10.2 kg |
UDIN00181698AM22
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Yellow WS-230.850 KGS) (No. of |
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BP / EP / USP / PH.EUR |
BP / EP / USP / PH.EUR |
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Tablets<br>95000000) |
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BP/EP/USP/PH.EUR) |
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| 3 |
BETAPYN<br>TABLETS<br>- |
1 Million |
1 |
COLOUR YELLOW 14037 |
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<br>Do not match |
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(Paracetamol 450mg + Caffeine |
<br>Tablets |
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IH |
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with MBF |
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50mg + Doxylamine Succinate 5mg |
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+<br>Colour<br>Yellow<br>14037- |
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1.848mg+Codeine Phosphate 10mg<br>Tablets) (Para -1125.000+ Caff - |
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4 |
CODIENE<br>PHOSPHATE<br>BP / EP / USP / PH.EUR |
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<br>10.2 kg |
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125.000<br>Doxy-12.500+Colour |
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Yellow 14037-4.620 Codeine - |
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25.00<br>KGS<br>(No.<br>of<br>Tablets |
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2500000) BP / EP / USP / |
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PH.EUR) |
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| 4 |
PYNSTOP<br>TABLETS<br>- |
<br>1 Million |
4 |
CODIENE |
PHOSPHATE |
<br>10.2 kg |
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(Paracetamol 450mg + Caffeine 45 |
<br>Tablets |
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BP / EP / USP / PH.EUR |
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mg + Doxylamine Succinate 5mg + |
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Codeine Phosphate 10mg Tablets |
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(Para -1125.000+ Caff -112.500 |
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Doxy-12.500+Colour<br>Yellow |
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14037-4.620 Codeine -25.00 KGS |
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(No. of Tablets 2500000) BP / EP / |
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USP / PH.EUR) |
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| Case No.<br>47 / NC/3/MEET/Oct/202122/10 |
| Case Status<br>Case Approved |
| Party Name<br>ADCOCK INGRAM LIMITED |
| Meeting Number and Date NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number<br>018205001813AM21 |
| RA File Number<br>072404000217 AM21 |
| Licence No and Date<br>0710117219/03/11/2020 |
| Norms Committee Decision: |
| The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP |
| Vol. I as per details given below or as applied by the firm, whichever is less:<br> |
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:
UDIN00181698AM22
|
Sl. No |
. |
Export product |
Qty. |
Sl. No |
. |
Import items |
|
Qty. |
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1 |
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SYNDOL TABLETS - (Paracetamol<br>450mg<br>+<br>Caffeine<br>30mg<br>+<br>Doxylamine<br>Succinate<br>5mg<br>+<br>Codeine Phosphate 10mg Colour<br>Yellow<br>14037-1.632mg)<br>(Para<br>-<br>6750.000+Caff<br>-450.000+<br>Doxy-<br>75.000+Codeine - 150.000 Colour<br>Yellow 14037-24.480 KGS) (No. of<br>Tablets<br>15000000)<br>BP/EP/USP/PH.EUR) |
<br> <br> <br> <br> <br> <br> <br> <br>1 Million<br>Tablets |
1 |
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COLOUR YELLOW 14037<br>IH |
<br> |
1.632 kg |
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4 |
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CODIENE<br>PHOSPHATE |
<br> |
10.2 kg |
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BP / EP / USP / PH.EUR |
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2 |
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ADCO<br>DOL<br>TABLETS<br>-<br>(Paracetamol<br>450mg+Codeine<br>Phosphate<br>10mg+Caffeine<br>45mg+Doxylamine<br>Succinate<br>5mg+Colour Yellow Lake-4.56mg+<br>Colour<br>Yellow<br>WS-2.43mg)(Para-<br>42750.000+Codeine-<br>950.000+Caff-<br>4275.000+Doxy-475.000<br>Colour<br>Yellow Lake-433.200 Colour Yellow<br>WS-230.850 KGS)(No. of Tablets<br>95000000)BP/EP/USP/PH.EUR) |
<br> <br> <br> <br> <br> <br> <br>1 Million<br>Tablets |
2 |
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COLOUR<br>QUINOLINE<br>YELLOW<br>WS |
<br> <br> |
2.43 kg |
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3<br>4 |
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(SPECTRACOL) |
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COLOUR<br>QUINOLINE<br>YELLOW<br>LAKE<br>IH<br>(SPECTRACOL) |
<br> <br> |
4.56 kg |
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CODIENE<br>PHOSPHATE<br>BP / EP / USP / PHEUR |
<br> |
10.2 kg |
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. |
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3 |
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BETAPYN TABLETS -(Paracetamol<br>450mg + Caffeine 50mg+Doxylamine<br>Succinate 5mg + Colour Yellow<br>14037-1.848mg+Codeine<br>Phosphate<br>10mg Tablets) (Para -1125.000+ Caff<br>125000<br>D12500Cl |
<br> <br> <br> <br> <br> <br>1 Million<br>Tablets |
1 |
|
COLOUR YELLOW 14037 |
<br> |
h |
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4 |
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<br>IH |
<br> <br> |
o not matc<br>with MBF |
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CODIENE<br>PHOSPHATE<br>BP / EP / USP / PH.EUR |
<br> |
10.2 kg |
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-.<br>oxy-.+oour<br>Yellow 14037-4.620 Codeine -25.00<br>KGS (No. of Tablets 2500000) BP /<br>EP / USP / PH.EUR) |
<br> <br> |
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4 |
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PYNSTOP TABLETS - (Paracetamol<br>450mg<br>+<br>Caffeine<br>45mg<br>+<br>Doxylamine<br>Succinate<br>5mg<br>+<br>Codeine Phosphate 10mg Tablets<br>P<br>1125000<br>Cff<br>112500 |
<br> <br> <br> <br> <br>1 Million<br>Tablets |
4 |
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CODIENE<br>PHOSPHATE<br>BP / EP / USP / PH.EUR |
<br> |
10.2 kg |
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(ara<br>-.+<br>a<br>-.<br>Doxy-12.500+Colour Yellow 14037-<br>4.620 Codeine -25.00 KGS (No. of<br>Tablets 2500000) BP / EP / USP /<br>PH.EUR) |
<br> <br> |
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UDIN00181698AM22
| Case No. |
48 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
HIMALAYAN PRODUCTS AND INDUSTRIES CORPN PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001814AM21 |
| RA File Number |
052404000396 AM21 |
| Licence No and<br>Date |
0510415723/03/11/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i. |
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| Case No. |
49 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
ALPHAMED FORMULATIONS PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001816AM21 |
| RA File Number |
092404000410 AM21 |
| Licence No and<br>Date |
0910069429/03/11/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i. |
|
Case No. 50 / NC/3/MEET/Oct/202122/10
UDIN00181698AM22
| Case Status |
Case Approved |
| Party Name |
HONOUR LAB LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001817AM21 |
| RA File Number |
092404000404 AM21 |
| Licence No and<br>Date |
0910069433/03/11/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting<br>No.NC/3MEET/Jul/202122/4 dated 15.07.2021against Advance Authorization No.0911000524 dated 16.03.2021, it<br>was decided to ratify adhoc norms under Para 4.07 of HBP vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>N,N-Dimethyl formamide<br>56,000 kg<br>2<br>Hexamethyl disilazane<br>141600 kg<br>3<br>Cytosine<br>86800 kg<br>(1R,2S,5R)-2-Isopropyl-5-<br>methylcyclohexyl-(2R,5S)-5-(4-amino-2-<br>oxopyrimidin-1-(2H)-yl)-1,3-oxathiolane-2-<br>carboxylate(OR) Cyclohexyl Ester (PE)<br>(OR) Cyclohexyl Ester HN<br>200000 kg<br>4<br>Triphosgene<br>1,00,000 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
| Case No. |
51 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
SREEPATHI PHARMACEUTICALS LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001820AM21 |
| RA File Number |
092404000442 AM21 |
| Licence No and<br>Date |
0910069435/04/11/2020 |
| Norms Committee Decision: |
|
UDIN00181698AM22
i. Percentage yield on molar basis for each step.
Production / Consumption data duly certified by GST.
| Case No. |
Case No. |
52 / NC/3/MEET/Oct/202122/10 |
52 / NC/3/MEET/Oct/202122/10 |
52 / NC/3/MEET/Oct/202122/10 |
52 / NC/3/MEET/Oct/202122/10 |
52 / NC/3/MEET/Oct/202122/10 |
| Case Status |
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Case Approved |
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| Party Name |
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SUVEN PHARMACEUTICALS LIMITED |
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| Mi Nb |
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| eetng umer<br>and Date |
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NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
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| HQ File Number |
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018205001823AM21 |
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| RA File Number |
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092404000445 AM21 |
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| Licence No and<br>Date |
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0910069441/04/11/2020 |
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| Norms Committee |
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Decision: |
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| The Committee co<br>Vol. I as per detail |
|
nsidered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>s given below or as applied by the firm, whichever is less: |
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Export product |
|
Qty. |
Sl. No. |
Import items |
Qty. |
|
TERT-BUTYL-4-(6-AMINOPYRIDAZIN-3-<br>YL)PIPERIDINE-1-CARBOXYLATE |
|
1 kg |
1 |
3-AMINO-6-CHLOROPYRIDAZINE |
0.66 kg |
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2 |
3,6-DIHYDRO-2H-PYRIDINE-1-N-Boc-4- |
1.58 kg |
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BORONIC ACID PINACOL ESTER |
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3 |
1,1-BIS<br>(DIPHENYL<br>PHOSPHINO)<br>FERROCENE<br>PALLADIUM<br>(II) |
<br> <br>0.04 kg |
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DICHLORIDE METHANE COMPLEX |
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| RA concerned may |
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take further necessary action as per above decision of NC. |
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| Case No. |
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53 / NC/3/MEET/Oct/202122/10 |
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| Case Status |
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Case Deferred |
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| Party Name |
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AARTI DRUGS LIMITED |
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| Meeting Number |
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NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
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| Case No. |
53 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
AARTI DRUGS LIMITED |
| Meeting Number |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
UDIN00181698AM22
| and Date |
|
| HQ File Number |
018205001818AM21 |
| RA File Number |
039404001085 AM20 |
| Licence No and<br>Date |
0310839307/04/11/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i. |
|
| Case No. |
54 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
DEEPAK PHENOLICS LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001834AM21 |
| RA File Number |
342404000202 AM21 |
| Licence No and<br>Date |
3410046526/05/11/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i.<br>Stoichiometric balance, molecular weight, percentage yield at every stage of reaction.<br>ii. |
|
| Case No. |
55 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
BHARAT SERUMS AND VACCINES LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001824AM21 |
| RA File Number |
039404000594 AM21 |
| Licence No and<br>Date |
0310839355/05/11/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to refer the case to Department of Biotechnology<br>(DBT). |
|
UDIN00181698AM22
| Case No. |
56 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
TIDE INDUSTRIES |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001835AM21 |
| RA File Number |
342404000204 AM21 |
| Licence No and<br>Date |
3410046524/05/11/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i.<br>Stoichiometric balance, molecular weight, percentage yield at every stage of reaction.<br>ii. |
|
| Case No. |
57 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
AARTI DRUGS LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001826AM21 |
| RA File Number |
039404000596 AM21 |
| Licence No and<br>Date |
0310839361/05/11/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E. |
|
| Case No. |
58 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
AARTI DRUGS LIMITED |
| Meeting Number |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
UDIN00181698AM22
| and Date |
|
| HQ File Number |
018205001827AM21 |
| RA File Number |
039404000597 AM21 |
| Licence No and<br>Date |
0310839362/05/11/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E. |
|
| Case No. |
59 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
SUN PHARMACEUTICAL INDUSTRIES LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001832AM21 |
| RA File Number |
052404000405 AM21 |
| Licence No and<br>Date |
0510415761/06/11/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Complete and balanced chemical reactions showing molecular weight and percentage yield on molar<br>basis.<br>i.<br>Requirement and recovery of solvent of each step.<br>ii.<br>Production / Consumption data duly certified by GST Authority.<br>iii. |
|
i. Complete and balanced chemical reactions showing molecular weight and percentage yield on molar basis.
| Case No. |
60 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
STERLING AUXILIARIES PVT LTD |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001828AM21 |
| RA File Number |
039504000492 AM21 |
| Licence No and<br>Date |
0310839386/06/11/2020 |
UDIN00181698AM22
Norms Committee Decision:
Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.
| Case No. |
61 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
EAST AFRICAN INDIA OVERSEAS |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001829AM21 |
| RA File Number |
052304000263 AM21 |
| Licence No and<br>Date |
0510415769/06/11/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E. |
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| Case No. |
62 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
VENOR PHARMA LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001831AM21 |
| RA File Number |
052404000391 AM21 |
| Licence No and<br>Date |
0510415763/06/11/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> |
|
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:
UDIN00181698AM22
| Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Inj. Sufentanil Citrate Eq. to Sufentanil<br>50mcg/ml, 1ml Ampoule<br>50000 Numbers<br>1<br>Sufentanil Citrate<br>4.117 grams<br>RA concerned may take further necessary action as per above decision of NC. |
Export product |
Qty. |
Sl. No. |
Import items |
Qty. |
|
Inj. Sufentanil Citrate Eq. to Sufentanil<br>50mcg/ml, 1ml Ampoule |
<br>50000 Numbers |
1 |
Sufentanil Citrate |
4.117 grams |
| Case No. |
63 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
SRF LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001836AM21 |
| RA File Number |
052404000395 AM21 |
| Licence No and<br>Date |
0510415782/09/11/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i.<br>Stoichiometric balance, molecular weight, percentage yield at every stage of reaction.<br>ii. |
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| Case No. |
64 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
AUROBINDO PHARMA LTD |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001839AM21 |
| RA File Number |
092404000455 AM21 |
| Licence No and<br>Date |
0910069458/09/11/2020 |
| Norms Committee Decision: |
|
UDIN00181698AM22
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:
| Export product |
Qty. |
Sl. No. |
Import items |
Qty. |
| FONDAPARINUX SODIUM |
1 kg |
1 |
N-3 Intermediate of Fondaparinux |
1.923 kg |
| Case No. |
65 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
AETHER INDUSTRIES LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001840AM21 |
| RA File Number |
522404000060 AM21 |
| Licence No and<br>Date |
5210043591/09/11/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Name of the specific Export Product.<br>i.<br>Molecular weight of export and imports.<br>ii.<br>Percentage yield at every stage of reaction. |
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| Case No. |
66 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
AARTI DRUGS LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001844AM21 |
| RA File Number |
039404000423 AM21 |
UDIN00181698AM22
| Licence No and<br>Date |
0310839485/11/11/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i. |
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| Case No. |
67 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
S KANT CHEMICALS PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001852AM21 |
| RA File Number |
039504000475 AM21 |
| Licence No and<br>Date |
0310839501/12/11/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>ACYCLOVIR<br>1 kg<br>1<br>Diacetyl Acyclovir<br>1.378 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
| Case No. |
68 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
PORUS LABORATORIES PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001854AM21 |
| RA File Number |
092404000378 AM21 |
UDIN00181698AM22
| Licence No and<br>Date |
0910069472/12/11/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i. |
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| Case No.<br>69 / NC/3/MEET/Oct/202122/10 |
Case No.<br>69 / NC/3/MEET/Oct/202122/10 |
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| Case Status<br>Case Approved |
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| Party Name<br>GLAND PHARMA LIMITED |
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| Meeting Number<br>and Date<br>NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
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| HQ File Number<br>018205001855AM21 |
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| RA File Number<br>092404000431 AM21 |
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| Licence No and<br>Date<br>0910069477/12/11/2020 |
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| Norms Committee Decision: |
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| The Committee considered the case as per agenda and it was decided |
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to ratify adhoc norms under Para 4.07 of |
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HBP |
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| Vol. I as per details given below or as applied |
by the firm, whichever is less: |
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| Sl. No. Export product |
Qty. |
Sl. No. |
Import items |
Qty. |
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| 1<br>Milrinone Lactate in 5% Dextrose |
<br>1 Number |
1 |
Milrinone |
21.00 mg |
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| Injection 20mg/100ml (200mcg |
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| (0.2mg) per ml), 100ml Infusion<br>Bag |
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2 |
Twist off Port Stoppers |
Relevant<br>as<br>packing policy |
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per |
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| 2<br>Milrinone Lactate in 5% Dextrose |
<br>1 Number |
1 |
Milrinone |
42.00 mg |
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| Injection 40mg/200ml (200mcg |
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| (0.2mg) per ml), 200ml Infusion<br>Bag |
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2 |
Twist off Port Stoppers |
Relevant<br>as<br>packing policy |
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per |
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| <br>RA concerned may take further necessary action as per above decision |
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of NC. |
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UDIN00181698AM22
| Case No. |
70 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
ORIENTAL AROMATICS LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001851AM21 |
| RA File Number |
039504000423 AM21 |
| Licence No and<br>Date |
0310839500/12/11/2020 |
| Norms Committee Decision: |
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| The Committee considered the case as per agenda and it was decided to call for following information from the firm: |
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| Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i. |
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| Case No. |
Case No. |
Case No. |
71 / NC/3/MEET/Oct/202122/10 |
71 / NC/3/MEET/Oct/202122/10 |
71 / NC/3/MEET/Oct/202122/10 |
| Case Status |
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Case Deferred |
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| P |
arty Name |
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ALEOR DERMACEUTICALS LIMITED |
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| M<br>an |
eeting Nu |
mber |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
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d Date |
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Q File Nu |
mber |
018205001853AM21 |
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A File Nu |
ber |
342404000223 AM21 |
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| Licence No and<br>Date |
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3410046549/13/11/2020 |
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| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i. |
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| Case No. |
72 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
SV PLASTOCHEM PRIVATE LIMITED |
UDIN00181698AM22
| Meeting Number<br>and Date<br>NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number<br>018205001856AM21 |
| RA File Number<br>318304000097 AM21 |
| Licence No and<br>Date<br>3110067922/17/11/2020 |
| Norms Committee Decision: |
| The Committee considered the case as per agenda and it was decided to call for following information from the firm: |
| Percentage purity of export item.<br>i. |
| Percentage yield at every stage of reaction.<br>ii. |
| Justification for quantity asked on the basis of chemistry, molecular weight and yield |
| Case No. |
73 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
CADILA HEALTHCARE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
018205001857AM21 |
| RA File Number |
082404000160 AM21 |
| Licence No and<br>Date |
0810149078/18/11/2020 |
| Norms Committee Decision: |
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| The Committee considered the case as per agenda and it was decided to call for following information from the firm: |
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| Stepwise percentage yield on molar basis for conversion of Clindamycin Hcl to Phosphate.<br>i. |
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| Copy of Master –Batch Formula showing net content of inputs in the export product.<br>ii. |
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| Content of Clindamycin (Base) in the import item Clindamycin Hcl in line with approved composition in |
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| DML. |
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| Case No. |
74 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
MANKIND PHARMA LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
UDIN00181698AM22
| HQ File Number |
HQRNORM APPLY 00032850AM21 |
| RA File Number |
052404000450 AM21 |
| Licence No and<br>Date |
0511000017/07/12/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i. |
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| Case No. |
75 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
BALAJI SPECIALITY CHEMICALS PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00032885AM21 |
| RA File Number |
31AA04003854 AM21 |
| Licence No and<br>Date |
3111000010/07/12/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting<br>No.**NC/3/MEET/Sep/202122/8 dated 24.09.2021 **against Advance Authorization No.3110067744 dated 26.05.2020, it<br>was decided to ratify adhoc norms under Para 4.07 of HBP vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>MONOETHANOLAMINE<br>1.06 kg<br>ETHYLENE DIAMINE (SPECIALITY<br>CHEMICALS)<br>1 kg<br>2<br>AMMONIA ANHYDROUS<br>0.294 kg<br>RA concerned may take further necessary action as per above decision of NC. |
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UDIN00181698AM22
| Case No. |
76 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
MANKIND PHARMA LIMITED |
| Meeting Number and<br>Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00033446AM21 |
| RA File Number |
05AA04017794 AM21 |
| Licence No and Date |
0511000038/08/12/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>ACETAZOLAMIDE<br>TABLETS<br>USP 125 MG (125MG)<br>1 Tablet<br>1<br>ACETAZOLAMIDE USP<br>127.5 mg /<br>125 mg Tablet<br>2<br>ACETAZOLAMIDE TABLETS<br>USP 250 MG (250 MG)<br>1 Tablet<br>1<br>ACETAZOLAMIDE USP<br>255.0 mg /<br>250 mg Tablet<br>RA concerned may take further necessary action as per above decision of NC. |
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| Case No. |
77 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
ADCOCK INGRAM LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00038384AM21 |
| RA File Number |
07AA04005691 AM21 |
| Licence No and<br>Date |
0711000056/14/12/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> |
|
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:
UDIN00181698AM22
|
Sl. No. |
Export product |
Qty. |
Sl. No. |
Import items |
Qty. |
|
1 |
SYNDOL<br>TABLETS<br>-<br>(Paracetamol 450mg + Caffeine<br>30mg + Doxylamine Succinate<br>5mg + Codeine Phosphate 10mg<br>Colour Yellow 14037-1.632mg)<br>(Para - 6750.000+Caff -450.000+<br>Doxy-75.000+Codeine - 150.000<br>Colour<br>Yellow<br>14037-24.480<br>KGS) (No. of Tablets 15000000)<br>BP/EP/USP/PH.EUR) |
<br> <br> <br> <br> <br> <br> <br> <br> <br>1 Million<br>Tablets |
1 |
COLOUR<br>YELLOW<br>14037 IH |
<br>1.632 kg |
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4 |
CODIENE PHOSPHATE<br>BP / EP / USP / PH.EUR |
<br>10.2 kg |
|
2 |
ADCO<br>DOL<br>TABLETS<br>-<br>(Paracetamol<br>450mg+Codeine<br>Phosphate 10mg<br>+Caffeine<br>45mg+Doxylamine<br>Succinate<br>5mg+Colour<br>Yellow<br>Lake-4.56mg+ Colour Yellow WS-<br>2.43mg)<br>(Para-<br>42750.000+<br>Codeine-<br>950.000<br>+<br>Caff-<br>4275.000+Doxy-475.000<br>Colour<br>Yellow<br>Lake-433.200<br>Colour<br>Yellow WS-230.850 KGS) (No. of<br>Tablets<br>95000000)<br>BP/EP/USP/PH.EUR) |
<br> <br> <br> <br> <br> <br> <br> <br>1 Million<br>Tablets |
2 |
COLOUR<br>QUINOLINE<br>YELLOW<br>WS<br>(SPECTRACOL) |
<br> <br>2.43 kg |
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3 |
COLOUR<br>QUINOLINE<br>YELLOW<br>LAKE<br>IH<br>(SPECTRACOL) |
<br> <br>4.56 kg |
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4 |
CODIENE PHOSPHATE<br>BP / EP / USP / PH.EUR |
<br>10.2 kg |
|
3 |
BETAPYN<br>TABLETS<br>-<br>(Paracetamol 450mg + Caffeine<br>50mg + Doxylamine Succinate<br>5mg + Colour Yellow 14037-<br>1.848mg+Codeine Phosphate 10mg<br>Tablets) (Para -1125.000+ Caff -<br>125.000<br>Doxy-12.500+Colour<br>Yellow 14037-4.620 Codeine -<br>25.00<br>KGS<br>(No.<br>of<br>Tablets<br>2500000) BP / EP / USP /<br>PH.EUR) |
<br> <br> <br> <br> <br> <br>1 Million<br>Tablets |
1 |
COLOUR<br>YELLOW<br>14037 IH |
<br>Do<br>not<br>match<br>with MBF |
|
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4 |
CODIENE PHOSPHATE<br>BP / EP / USP / PH.EUR |
<br>10.2 kg |
|
4 |
PYNSTOP<br>TABLETS<br>-<br>(Paracetamol 450mg + Caffeine 45<br>mg +<br>Doxylamine<br>Succinate<br>5mg<br>+<br>Codeine Phosphate 10mg Tablets<br>(Para -1125.000+ Caff -112.500<br>Doxy-12.500+Colour<br>Yellow<br>14037-4.620 Codeine -25.00 KGS |
<br> <br> <br> <br> <br> <br> <br>1 Million<br>Tablets |
4 |
CODIENE PHOSPHATE<br>BP / EP / USP / PH.EUR |
<br>10.2 kg |
UDIN00181698AM22
(No. of Tablets 2500000) BP / EP / USP / PH.EUR)
| Case No. |
Case No. |
Case No. |
78 / NC/3/MEET/Oct/202122/10 |
78 / NC/3/MEET/Oct/202122/10 |
78 / NC/3/MEET/Oct/202122/10 |
78 / NC/3/MEET/Oct/202122/10 |
78 / NC/3/MEET/Oct/202122/10 |
| Case Status |
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Case Approved |
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| Party Name |
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ADCOCK INGRAM LIMITED |
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| Meeting Number<br>and Date |
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NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
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| HQ File Number |
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HQRNORM APPLY 00038387AM21 |
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| RA File Number |
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07AA04005690 AM21 |
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| Licence No and<br>Date |
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|
0711000055/14/12/2020 |
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| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>COLOUR<br>YELLOW<br>14037 IH<br>1.632 kg<br>1<br>SYNDOL<br>TABLETS<br>-<br>(Paracetamol 450mg + Caffeine<br>30mg + Doxylamine Succinate 5mg<br>+ Codeine Phosphate 10mg Colour<br>Yellow 14037-1.632mg) (Para -<br>6750.000+Caff -450.000+ Doxy-<br>75.000+Codeine - 150.000 Colour<br>Yellow 14037-24.480 KGS) (No.<br>of<br>Tablets<br>15000000)<br>BP/EP/USP/PH.EUR)<br>1 Million<br>Tablets<br>2<br>CODIENE PHOSPHATE<br>BP / EP / USP / PH.EUR<br>10.2 kg<br>2<br>COLOUR<br>QUINOLINE<br>YELLOW<br>WS<br>(SPECTRACOL)<br>2.43 kg<br>ADCO<br>DOL<br>TABLETS<br>-<br>(Paracetamol<br>450mg+Codeine<br>Phosphate 10mg<br>+Caffeine<br>45mg+Doxylamine<br>Succinate<br>5mg+Colour<br>Yellow<br>Lake-4.56mg+ Colour Yellow WS-<br>2.43mg)<br>(Para-<br>42750.000+<br>COLOUR<br>QUINOLINE<br>YELLOW<br>LAKE<br>IH<br>2<br>1 Million<br>Tablets<br>3<br>4.56 kg |
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Sl. No. |
Export product |
|
Qty. |
Sl. No. |
Import items |
Qty. |
|
1 |
SYNDOL<br>TABLETS<br>-<br>(Paracetamol 450mg + Caffeine<br>30mg + Doxylamine Succinate 5mg<br>+ Codeine Phosphate 10mg Colour<br>Yellow 14037-1.632mg) (Para -<br>6750.000+Caff -450.000+ Doxy-<br>75.000+Codeine - 150.000 Colour<br>Yellow 14037-24.480 KGS) (No.<br>of<br>Tablets<br>15000000)<br>BP/EP/USP/PH.EUR) |
|
<br> <br> <br> <br> <br> <br> <br> <br>1 Million<br>Tablets |
1 |
COLOUR<br>YELLOW<br>14037 IH |
<br>1.632 kg |
|
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|
|
|
2 |
CODIENE PHOSPHATE<br>BP / EP / USP / PH.EUR |
<br>10.2 kg |
|
2 |
ADCO<br>DOL<br>TABLETS<br>-<br>(Paracetamol<br>450mg+Codeine<br>Phosphate 10mg<br>+Caffeine<br>45mg+Doxylamine<br>Succinate<br>5mg+Colour<br>Yellow<br>Lake-4.56mg+ Colour Yellow WS-<br>2.43mg)<br>(Para-<br>42750.000+ |
|
<br> <br> <br> <br>1 Million<br>Tablets |
2 |
COLOUR<br>QUINOLINE<br>YELLOW<br>WS<br>(SPECTRACOL) |
<br> <br>2.43 kg |
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|
3 |
COLOUR<br>QUINOLINE<br>YELLOW<br>LAKE<br>IH |
<br> <br>4.56 kg |
| Case No. |
Case No. |
Case No. |
78 / NC/3/MEET/Oct/202122/10 |
78 / NC/3/MEET/Oct/202122/10 |
78 / NC/3/MEET/Oct/202122/10 |
78 / NC/3/MEET/Oct/202122/10 |
78 / NC/3/MEET/Oct/202122/10 |
| Case Status |
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Case Approved |
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| Party Name |
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ADCOCK INGRAM LIMITED |
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| Meeting Number<br>and Date |
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|
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
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| HQ File Number |
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|
HQRNORM APPLY 00038387AM21 |
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| RA File Number |
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|
07AA04005690 AM21 |
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| Licence No and<br>Date |
|
|
0711000055/14/12/2020 |
|
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|
|
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>COLOUR<br>YELLOW<br>14037 IH<br>1.632 kg<br>1<br>SYNDOL<br>TABLETS<br>-<br>(Paracetamol 450mg + Caffeine<br>30mg + Doxylamine Succinate 5mg<br>+ Codeine Phosphate 10mg Colour<br>Yellow 14037-1.632mg) (Para -<br>6750.000+Caff -450.000+ Doxy-<br>75.000+Codeine - 150.000 Colour<br>Yellow 14037-24.480 KGS) (No.<br>of<br>Tablets<br>15000000)<br>BP/EP/USP/PH.EUR)<br>1 Million<br>Tablets<br>2<br>CODIENE PHOSPHATE<br>BP / EP / USP / PH.EUR<br>10.2 kg<br>2<br>COLOUR<br>QUINOLINE<br>YELLOW<br>WS<br>(SPECTRACOL)<br>2.43 kg<br>ADCO<br>DOL<br>TABLETS<br>-<br>(Paracetamol<br>450mg+Codeine<br>Phosphate 10mg<br>+Caffeine<br>45mg+Doxylamine<br>Succinate<br>5mg+Colour<br>Yellow<br>Lake-4.56mg+ Colour Yellow WS-<br>2.43mg)<br>(Para-<br>42750.000+<br>COLOUR<br>QUINOLINE<br>YELLOW<br>LAKE<br>IH<br>2<br>1 Million<br>Tablets<br>3<br>4.56 kg |
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Sl. No. |
Export product |
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Qty. |
Sl. No. |
Import items |
Qty. |
|
1 |
SYNDOL<br>TABLETS<br>-<br>(Paracetamol 450mg + Caffeine<br>30mg + Doxylamine Succinate 5mg<br>+ Codeine Phosphate 10mg Colour<br>Yellow 14037-1.632mg) (Para -<br>6750.000+Caff -450.000+ Doxy-<br>75.000+Codeine - 150.000 Colour<br>Yellow 14037-24.480 KGS) (No.<br>of<br>Tablets<br>15000000)<br>BP/EP/USP/PH.EUR) |
|
<br> <br> <br> <br> <br> <br> <br> <br>1 Million<br>Tablets |
1 |
COLOUR<br>YELLOW<br>14037 IH |
<br>1.632 kg |
|
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|
|
2 |
CODIENE PHOSPHATE<br>BP / EP / USP / PH.EUR |
<br>10.2 kg |
|
2 |
ADCO<br>DOL<br>TABLETS<br>-<br>(Paracetamol<br>450mg+Codeine<br>Phosphate 10mg<br>+Caffeine<br>45mg+Doxylamine<br>Succinate<br>5mg+Colour<br>Yellow<br>Lake-4.56mg+ Colour Yellow WS-<br>2.43mg)<br>(Para-<br>42750.000+ |
|
<br> <br> <br> <br>1 Million<br>Tablets |
2 |
COLOUR<br>QUINOLINE<br>YELLOW<br>WS<br>(SPECTRACOL) |
<br> <br>2.43 kg |
|
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|
|
3 |
COLOUR<br>QUINOLINE<br>YELLOW<br>LAKE<br>IH |
<br> <br>4.56 kg |
UDIN00181698AM22
|
Codeine-<br>950.000<br>+<br>Caff-<br>4275.000+Doxy-475.000<br>Colour<br>Yellow<br>Lake-433.200<br>Colour<br>Yellow WS-230850 KGS) (No of |
Codeine-<br>950.000<br>+<br>Caff-<br>4275.000+Doxy-475.000<br>Colour<br>Yellow<br>Lake-433.200<br>Colour<br>Yellow WS-230850 KGS) (No of |
<br> <br> |
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(SPECTRACOL) |
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4 |
|
CODIENE PHOSPHATE |
<br>10.2 kg |
|
<br>Tablets |
. .<br>95000000) |
<br> |
|
|
BP / EP / USP / PH.EUR |
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|
BP/EP/U |
<br>SP/PH.EUR) |
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| 3 |
BETAP<br>(Paraceta |
YN<br>TABLETS<br>-<br>mol 450mg + Caffeine |
<br>1 Million<br>Tablets |
1 |
|
COLOUR<br>YELLOW<br>14037 IH |
<br>Do<br>not<br>match<br>with MBF |
|
<br>50mg + |
<br>Doxylamine Succinate 5mg |
<br> <br> |
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+<br>Co |
lour<br>Yellow<br>14037- |
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<br>k |
|
1.848mg<br>Tablets)<br> |
+Codeine Phosphate 10mg<br>(Para -1125.000+ Caff -<br> |
<br> |
4 |
|
CODIENE PHOSPHATE<br>BP / EP / USP / PH.EUR |
<br>10.2 g |
|
125.000<br>Doxy-12.500+Colour |
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|
| 4 |
Yellow 14037-4.620 Codeine -<br>25.00<br>KGS<br>(No.<br>of<br>Tablets<br>2500000) BP / EP / USP /<br>PH.EUR) |
|
<br> |
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|
PYNSTOP<br>TABLETS<br>- |
|
<br>1 Million |
4 |
|
CODIENE PHOSPHATE |
<br>10.2 kg |
|
(Paracetamol 450mg + Caffeine 45<br>mg +<br>Doxylamine<br>Succinate<br>5mg<br>+<br>Codeine Phosphate 10mg Tablets<br>P 1125000 Cff 112500 |
|
<br> <br> <br> <br>Tablets |
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|
BP / EP / USP / PH.EUR |
|
|
(ara -<br>Doxy-12 |
.+ a -.<br>500+Colour<br>Yellow |
<br> |
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<br>14037-4. |
.<br> <br>620 Codeine -25.00 KGS |
<br> |
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|
(No. of |
Tablets 2500000) BP / EP / |
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| USP / P |
USP / P |
H.EUR) |
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| RA concerned may |
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take further necessary action as per above dec |
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sion of NC. |
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| Case No. |
79 / NC/3/MEET/Oct/202122/10 |
79 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
|
| Party Name |
RECKITT BENCKISER (INDIA) PRIVATE LIMITED |
|
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|
|
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
|
| HQ File Number |
HQRNORM APPLY 00038763AM21 |
|
| RA File Number |
05AA04018762 AM21 |
|
| Li N d |
|
|
| cence o an<br>Date |
0511000178/15/12/2020 |
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| Norms Committee |
|
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|
|
|
UDIN00181698AM22
The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. 8/82-ALC4/2019 dated 20.09.2019 against Advance Authorization No. 0510405700 dated 21.02.2018 , it was decided to ratify adhoc norms under Para 4.07 of HBP vol. I as per details given below or as applied by the firm, whichever is less:
|
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| The Committee con<br>No.8/82-ALC4/201<br>to ratif adhoc norm |
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sidered the case as per agenda and taking cue fro<br>**9 dated 20.09.2019 **against Advance Authorizat<br>s under Para 407 of HBP vol I as er details iv |
|
|
m earlier decision for same export product in Meeting<br>ion No.0510405700 dated 21.02.2018, it was decided<br>n below or as alied b the firm whichever is less: |
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| y |
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. . p g |
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pp y , |
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Import items |
Qty. |
|
Sl. No. |
Export pro |
duct |
Qty. |
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1 |
DISPRIN<br>REGULAR<br>(ASPIRIN<br>PH.EUR<br>300MG)<br>ACETYL<br>SALICYLIC ACID 300 mg Tablet<br>(ASPIRIN) |
|
<br> <br> <br>1 Number |
1 |
|
CITIRIC ACID ANHYDROUS<br>F4020 |
30.00 mg / 300 mg<br>tablet |
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2 |
|
SACCHARIN BASE 55Ox |
4.50 mg / 300 mg<br>tablet |
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3 |
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CALCIUM CARBONATE EP |
90.0 mg / 300 mg<br>tablet |
|
2 |
DISPRIN EXTRA (ASPIRIN PHEUR |
|
<br>1 Number |
4 |
|
CITIRIC ACID ANHYDROUS |
5000 m / 500 m |
|
|
<br>500MG) |
.<br>ACETYL<br>SALICYLIC |
<br> <br> |
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|
<br>F4020 |
. g g<br>Tablet |
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ACID 500 |
mg Tablet (ASPIRIN) |
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5 |
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SACCHARIN BASE 55Ox |
7.50 mg / 500 mg |
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<br>Tablet |
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6 |
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CALCIUM CARBONATE EP |
1500 m / 500 m |
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. g g<br>Tablet |
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3 |
DISPRIN |
<br>DIRECTS<br>/<br>MELTS |
<br>1 Nb |
7 |
|
SACCHARIN BASE 55O |
100 / 300 |
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|
<br> <br> <br> <br> <br> <br> |
|
<br> <br>umer |
|
|
x |
. mg mg<br>Tablet |
|
|
(ASPIRIN<br>PH.EUR<br>300MG)<br>ACETYL SALICYLIC ACID 300 mg<br>Tablet (ASPIRIN) |
|
<br> |
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8 |
|
GLYCINE EP |
133.30 mg / 300<br>mg Tablet |
|
4 |
DISPRIN CARDIOCARE (ASPIRIN<br> |
|
<br> <br>1 Number |
9 |
|
SACCHARIN BASE 55Ox |
0.334 mg / Tablet |
| BP 100 MG) ACETYL SALICYLIC<br>ACID 100 mg Tablet (ASPIRIN)<br>10<br>GLYCINE EP<br>44.40 mg / Tablet |
|
BP 100 MG) ACETYL SALICYLIC<br>ACID 100 mg Tablet (ASPIRIN) |
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10 |
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GLYCINE EP |
44.40 mg / Tablet |
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| RA concerned may t |
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ake further necessary action as per above decisio |
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n of NC. |
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80 / NC/3/MEET/O/202122/10 |
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Case No. 80 / NC/3/MEET/Oct/202122/10
UDIN00181698AM22
| Case Status |
Case Deferred |
| Party Name |
RISHABH METALS & CHEMICALS PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00038772AM21 |
| RA File Number |
039504000554 AM21 |
| Licence No and<br>Date |
0311000111/15/12/2020 |
| Norms Committee Decision: |
|
| The Committee considered the case as per agenda and it was decided to call for following information from the firm: |
|
| Detailed chemistry, molecular weight of import and export, percentage yield.<br>i. |
|
| Stoichiometric balance between import and export.<br>ii. |
|
| Structural<br>iii. |
formula of import and export. |
| Case No. |
81 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
SYNTHO CHIRALS PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00038802AM21 |
| RA File Number |
09AA04002748 AM21 |
| Licence No and<br>Date |
0911000023/15/12/2020 |
| Norms Committee Decision: |
|
| The Committee considered the case as per agenda and it was decided to call for following information from the firm: |
|
| Catalogue of import item and export item.<br>i. |
|
| Production / Consumption data for last two years duly certified by GST,<br>ii. |
|
| Case No. |
82 / NC/3/MEET/Oct/202122/10 |
82 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
|
| Party Name |
MAC-CHEM PRODUCTS (INDIA) PRIVATE |
LIMITED |
| Meeting Number |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
|
| and Date |
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|
| HQ File Number |
HQRNORM APPLY 00038982AM21 |
|
| RA File Number |
03AA04011435 AM21 |
|
UDIN00181698AM22
| Licence No and<br>Date |
0311000187/15/12/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i. |
|
| Case No. |
83 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
LIBERTY LIFE SCIENCES |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00038992AM21 |
| RA File Number |
03AA04012047 AM21 |
| Licence No and<br>Date |
0311000190/15/12/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>COA of Import item from foreign supplier.<br>i.<br>COA of Export item.<br>ii.<br>Process – wastage claimed. |
|
| Case No. |
84 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
LEBEN LABORATORIES PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00039492AM21 |
| RA File Number |
03AA04013177 AM21 |
| Licence No and<br>Date |
0311000200/16/12/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of DML showing Approved Composition. |
|
UDIN00181698AM22
| Case No. |
85 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
ORGANIC INDIA PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00039895AM21 |
| RA File Number |
06AA04002281 AM21 |
| Licence No and<br>Date |
0611000019/16/12/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per Agenda and it was observed that the Export Product appears to be food<br>items, which are dealt in Norms Committee-6. Hence, it was decided totransfer the case to NC-6. |
|
| Case No. |
86 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
MAC-CHEM PRODUCTS (INDIA) PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00040306AM21 |
| RA File Number |
03AA04011434 AM21 |
| Licence No and<br>Date |
0311000185/17/12/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i. |
|
| Case No. |
87 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
CADILA HEALTHCARE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00041626AM21 |
UDIN00181698AM22
| RA File Number |
08AA04004845 AM21 |
| Licence No and<br>Date |
0811000109/18/12/2020 |
| Norms Committee Decision:<br>Deferred for comments of TE. |
|
| Case No. |
88 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
OPTIMUS DRUGS PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00042021AM21 |
| RA File Number |
09AA04002675 AM21 |
| Licence No and<br>Date |
0911000050/18/12/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Percentage yield on molar basis for each step.<br>i.<br>Production / Consumption data certified by GST Authorities.<br>ii.<br>End – use of export item. |
|
| Case No. |
89 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
ZENITH DYEINTERMEDIATES LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00042084AM21 |
| RA File Number |
039504000539 AM21 |
| Licence No and<br>Date |
0311000203/18/12/2020 |
| Norms Committee Decision:<br>Deferred for comments of TE. |
|
UDIN00181698AM22
| Case No.<br>90 / NC/3/MEET/Oct/202122/10 |
Case No.<br>90 / NC/3/MEET/Oct/202122/10 |
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| Case Status<br>Case Approved |
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| Party Name<br>SENTISS PHARMA PRIVATE |
LIMITED |
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| Meeting Number<br>and Date<br>NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
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| HQ File Number<br>HQRNORM APPLY 00043900AM21 |
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| RA File Number<br>05AA04019532 AM21 |
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| Licence No and<br>Date<br>0511000310/21/12/2020 |
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| Norms Committee Decision: |
|
|
|
|
|
|
| The Committee considered the case as per agenda |
|
and it was decided to ratify adhoc norms under Para 4.07 of HBP |
|
|
|
|
| Vol. I as per details given below or as applied by the firm, whichever is<br> |
|
|
|
less: |
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|
| Export product |
|
Qty. |
Sl. No. |
Import items |
Qty. |
|
| Brinex / Brinex- M / Brinarga / Brinera |
|
1 Vial |
1 |
Brinzolamide |
51.00 mg |
|
| (Brinzolamide<br>Opthalmic<br>Suspension<br>1%) |
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| 5ml(Brinex / Brinex-M / Brinarga / Brinera |
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| (Brinzolamide Opthalmic Suspension 1%) 5ml) |
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| RA concerned may take further necessary action as |
|
per above decision of NC. |
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| Case No. |
91 / NC/3/MEET/Oct/202122/10 |
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| Case Status |
Case Approved |
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| Party Name |
SENTISS PHARMA PRIVATE LIMITED |
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| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
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|
| HQ File Number |
NORM APPLY 00043942AM21 |
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| RA File Number |
05AA04019904 AM21 |
|
|
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| Licence No and<br>Date |
0511000306/21/12/2020 |
|
|
|
|
| Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting<br>No.10/82-ALC4/2019 dated 29.11.2019against Advance Authorization No.0510412191 dated 21.10.2019, it was<br>decided to ratify adhoc norms under Para 4.07 of HBP vol. I as per details given below or as applied by the firm, whichever |
|
|
|
|
|
UDIN00181698AM22
is less:
| Export product |
Qty. |
Sl. No. |
Import items |
Qty. |
| Mydrimax Eye Drops 5ml Vial (Each ml<br>Containing 8 mg Tropicamide) |
<br>1 Number |
1 |
Tropicamide |
40.8 mg / 5 ml vial |
| Case No. |
92 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
CIPLA LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00044044AM21 |
| RA File Number |
03AA04011698 AM21 |
| Licence No and<br>Date |
0311000235/21/12/2020 |
| Norms Committee Decision:<br>Deferred for comments of TE. |
|
| Case No. |
93 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
SENTISS PHARMA PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00043890AM21 |
| RA File Number |
05AA04019890 AM21 |
| Licence No and<br>Date |
0511000304/21/12/2020 |
| Norms Committee Decision: |
|
UDIN00181698AM22
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:
| Export product |
Qty. |
Sl. No. |
Import items |
Qty. |
| Prolatan Eye Drops 0.005% 2.5ml |
72727 Vials |
1 |
Isomer Free Latanoprost |
9.545 kg |
| Case No. |
94 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
SENTISS PHARMA PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00043898AM21 |
| RA File Number |
05AA04019899 AM21 |
| Licence No and<br>Date |
0511000307/21/12/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Inokain Eye Drops 0.4% 5ML (Eye Drops)<br>1 Vial<br>1<br>Benoxinate HCL<br>20.4 mg<br>RA concerned may take further necessary action as per above decision of NC. |
|
Case No. 95 / NC/3/MEET/Oct/202122/10
UDIN00181698AM22
| Case Status |
Case Deferred |
| Party Name |
RUBICON RESEARCH PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00044144AM21 |
| RA File Number |
039504000557 AM21 |
| Licence No and<br>Date |
0311000313/22/12/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i. |
|
| Case No. |
96 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00044916AM21 |
| RA File Number |
03AA04014068 AM21 |
| Licence No and<br>Date |
0311000348/22/12/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of DML for each export item showing Approved Composition. |
|
| Case No. |
97 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
FDC LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00045011AM21 |
| RA File Number |
03AA04013340 AM21 |
| Licence No and<br>Date |
0311000293/22/12/2020 |
UDIN00181698AM22
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:
|
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|
|
| Export product |
Qty. |
|
Sl. No |
. |
Import items |
|
Qty. |
| Loxoptic<br>Ophthalmic<br>Soln<br>5mg/ml((Betaxolol Eye Drops 5 ml)) |
1 Vial |
|
|
|
|
|
|
|
|
|
1 |
|
Betaxolol Hydrochloride |
|
28.56 mg |
|
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|
| Case No |
|
|
98 / NC/3/MEET/Oct/202122/10 |
|
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|
|
| . |
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|
|
| Case Status |
|
|
Case Approved |
|
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|
|
| Party Name |
|
|
GLAND PHARMA LIMITED |
|
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| Meeting Number<br>and Date |
|
|
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
|
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|
|
|
|
|
| HQ File Number |
|
|
HQRNORM APPLY 00045548AM21 |
|
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|
|
|
|
|
|
|
| RA File Number |
|
|
09AA04002728 AM21 |
|
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|
|
| Licence No and<br>Date |
|
|
0911000085/23/12/2020 |
|
|
|
|
|
|
|
|
|
|
|
|
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br> |
|
|
|
|
|
|
|
| Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Sl NEt dt<br>t<br>Sl NIt it<br>t |
|
|
|
|
|
|
|
|
Sl N |
Et dt |
|
t<br> |
Sl N |
It it |
t |
|
. o. |
xpor p |
ouc |
Qy.<br> |
. o. |
mpor ems |
Qy. |
|
|
|
|
|
|
|
|
|
1 |
Timolol<br> |
<br>Maleate<br>Ophthalmic<br>Gel<br> |
<br> <br>54500<br><br> |
1 |
Timolol Maleate |
945.03 grams |
|
|
Forming<br>(USP) |
Solution 0.25%, 5ml Bottle |
<br>Number |
|
|
|
|
|
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|
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|
|
|
|
|
|
|
|
2 |
Timolol |
<br>Maleate<br>Ophthalmic<br>Gel |
<br>436000<br> |
1 |
Timolol Maleate |
15120.50 grams |
|
|
Forming<br>(USP) |
Solution 0.5%, 5ml Bottle |
<br>Number |
|
|
|
|
|
|
|
|
|
|
|
UDIN00181698AM22
| Case No. |
99 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
AURORE LIFE SCIENCES PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00045614AM21 |
| RA File Number |
09AA04002686 AM21 |
| Licence No and<br>Date |
0911000086/23/12/2020 |
| Norms Committee Decision:<br>Deferred for comments of TE. |
|
| Case No. |
Case No. |
100 / NC/3/MEET/Oct/202122/10 |
100 / NC/3/MEET/Oct/202122/10 |
100 / NC/3/MEET/Oct/202122/10 |
100 / NC/3/MEET/Oct/202122/10 |
100 / NC/3/MEET/Oct/202122/10 |
| Case Status |
|
Case Approved |
|
|
|
|
| Party Name |
|
APEX DRUG HOUSE |
|
|
|
|
| Meeting Number<br>and Date |
|
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
|
|
|
|
| HQ File Number |
|
HQRNORM APPLY 00045876AM21 |
|
|
|
|
| RA File Number |
|
03AA04013443 AM21 |
|
|
|
|
| Licence No and<br>Date |
|
0311000381/23/12/2020 |
|
|
|
|
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Benzocaine & Dequalinium Chloride Lozenges<br>(ELIDOL DUO (Raspberry Flavour)) Each Lozenge<br>contains Benzocaine BP 10 MG, Dequalinium<br>Chloride BP 0.25 mg(Net Content : 1) Dequalinium<br>1 Number<br>1<br>Dequalinium Chloride BP<br>0.255 mg |
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl. No. |
Import items |
Qty. |
|
Benzocaine & Dequalinium Chloride Lozenges<br>(ELIDOL DUO (Raspberry Flavour)) Each Lozenge<br>contains Benzocaine BP 10 MG, Dequalinium<br>Chloride BP 0.25 mg(Net Content : 1) Dequalinium |
|
<br> <br> <br> <br>1 Number |
1 |
Dequalinium Chloride BP |
0.255 mg |
UDIN00181698AM22
Chloride BP - 341.379 Numbers. 2) Benzociane BP - 136.552 Numbers (Indigenous).)
| Case No. |
101 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
FINE ORGANIC INDUSTRIES LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00045885AM21 |
| RA File Number |
03AA04014235 AM21 |
| Licence No and<br>Date |
0311000376/23/12/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting<br>No.**4/82-ALC4/2018 dated 19.06.2018 **against Advance Authorization No.0310818353 dated 09.01.2018, it was decided<br>to ratify adhoc norms under Para 4.07 of HBP vol. I 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>1<br>LAURIC ACID<br>0.738 kg<br>Glyceryl Mono Laurate (GML)<br>1 kg<br>2<br>GLYCERINE<br>0.339 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
| Case No. |
102 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
JODAS EXPOIM PRIVATE LIMITED |
UDIN00181698AM22
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00045146AM21 |
| RA File Number |
092404000316 AM21 |
| Licence No and<br>Date |
0911000062/23/12/2020 |
| Norms Committee Decision: |
|
| The Committee considered the case as per agenda and it was decided to call for following information from the firm: |
|
|
(i) Copy of DML for export item. |
| COA of import items from foreign supplier. |
|
| Case No. |
103 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
GLAND PHARMA LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00045152AM21 |
| RA File Number |
09AA04002722 AM21 |
| Licence No and<br>Date |
0911000067/23/12/2020 |
| Norms Committee Decision: |
|
| The Committee considered the case as per agenda and it was decided to call for following information from the firm: |
|
| Complete technical details as per Annexure to Appendix 4E. |
|
| Case No. |
104 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
BALAJI SPECIALITY CHEMICALS PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00045431AM21 |
| RA File Number |
31AA04004412 AM21 |
| Licence No and<br>Date |
3111000042/23/12/2020 |
UDIN00181698AM22
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Sep/202122/8 dated 24.09.2021 against Advance Authorization No. 3110067744 dated 26.05.2020 , it was decided to ratify adhoc norms under Para 4.07 of HBP vol. I as per details given below or as applied by the firm, whichever is less:
| Export product |
Qty. |
Sl. No. |
Import items |
Qty. |
| ETHYLENE DIAMINE (SPECIALITY<br>CHEMICALS) |
<br>1 kg |
1 |
MONOETHANOLAMINE |
1.06 kg |
|
|
2 |
AMMONIA ANHYDROUS |
0.294 kg |
| Case No. |
105 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
BIOXERA PHARMA PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00046880AM21 |
| RA File Number |
03AA04014274 AM21 |
| Licence No and<br>Date |
0311000380/24/12/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>BENFOTIAMINE VITAMIN B1)<br>1 kg<br>1<br>THIAMINE HYDROCHLORIDE<br>0.922 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
UDIN00181698AM22
| Case No. |
106 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
SYNNAT PHARMA PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00046908AM21 |
| RA File Number |
02AA04006385 AM21 |
| Licence No and<br>Date |
0211000088/24/12/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Papaverine Hydrochloride BP/ Ph.Eur /<br>USP/ JP<br>1 kg<br>1<br>Papaverine Crude Content 95%<br>1.05 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
| Case No. |
107 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
R.L.FINE CHEM PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00046232AM21 |
| RA File Number |
07AA04006226 AM21 |
| Licence No and<br>Date |
0711000142/24/12/2020 |
| Norms Committee Decision:<br>Deferred for comments of TE. |
|
UDIN00181698AM22
| Case No. |
108 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
BEST VALUE CHEM PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00046234AM21 |
| RA File Number |
34AA04001528 AM21 |
| Licence No and<br>Date |
3411000040/24/12/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Complete technical details as per Annexure to Appendix 4E. |
|
| Case No. |
Case No. |
109 / NC/3/MEET/Oct/202122/10 |
109 / NC/3/MEET/Oct/202122/10 |
109 / NC/3/MEET/Oct/202122/10 |
109 / NC/3/MEET/Oct/202122/10 |
109 / NC/3/MEET/Oct/202122/10 |
| Case Status |
|
Case Approved |
|
|
|
|
| Party Name |
|
THINQ PHARMA-CRO LIMITED |
|
|
|
|
| Meeting Number<br>and Date |
|
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
|
|
|
|
| HQ File Number |
|
HQRNORM APPLY 00046340AM21 |
|
|
|
|
| RA File Number |
|
03AA04013380 AM21 |
|
|
|
|
| Licence No and<br>Date |
|
0311000264/24/12/2020 |
|
|
|
|
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Tretinoin (All Trans Retinoic Acid) 1.00 kg<br>2<br>1-Chloro Pinacolone<br>0.469 kg<br>G-101 (All Trans Retinoic Acid,1- Hydroxy-<br>3,3- dimethyl-2- Butanone Ester)((All Trans<br>Retinoic Acid,1- Hydroxy-3,3- dimethyl-2-<br>Butanone Ester))<br>1 kg |
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl. No. |
Import items |
Qty. |
|
G-101 (All Trans Retinoic Acid,1- Hydroxy-<br>3,3- dimethyl-2- Butanone Ester)((All Trans<br>Retinoic Acid,1- Hydroxy-3,3- dimethyl-2-<br>Butanone Ester)) |
|
1 kg |
1 |
Tretinoin (All Trans Retinoic Acid) |
1.00 kg |
|
|
|
|
2 |
1-Chloro Pinacolone |
0.469 kg |
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:
UDIN00181698AM22
3 Cesium Carbonate 1.135 kg
| Case No. |
110 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
SUPERMINT EXPORTS PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00046519AM21 |
| RA File Number |
05AA04020223 AM21 |
| Licence No and<br>Date |
0511000407/24/12/2020 |
| Norms Committee Decision:<br>Deferred for comments of TE. |
|
| Case No. |
Case No. |
Case No. |
111 / NC/3/MEET/Oct/202122/10 |
111 / NC/3/MEET/Oct/202122/10 |
111 / NC/3/MEET/Oct/202122/10 |
111 / NC/3/MEET/Oct/202122/10 |
111 / NC/3/MEET/Oct/202122/10 |
| Case Status |
|
|
Case Approved |
|
|
|
|
| Party Name |
|
|
ZENTIVA PRIVATE LIMITED |
|
|
|
|
| Meeting Number and<br>Date |
|
|
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
|
|
|
|
| HQ File Number |
|
|
HQRNORM APPLY 00048038AM21 |
|
|
|
|
| RA File Number |
|
|
03AA04014240 AM21 |
|
|
|
|
| Licence No and Date |
|
|
0311000408/28/12/2020 |
|
|
|
|
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty. |
|
|
|
|
|
|
|
|
Sl. No. |
Export product |
|
Qty. |
Sl. No. |
Import items |
Qty. |
UDIN00181698AM22
|
|
|
|
|
|
|
|
|
|
| 1<br>Ramilich / Ramilich Comp / Ramipril<br>HCT ZT/ZTV 5-12.5mg DE/FR(Net<br>Wt.<br>Hydrochlorothiazide<br>125.000<br>KGS)(NA)<br>1 Number<br>1<br>Hydrochlorothiazide<br>127.50 mg /<br>Tablet<br>2<br>Ramilich / Ramilich Comp / Ramipril<br>HCT ZT/ZTV 2.5- 12.5mg DE/IT (Net<br>Wt.<br>Hydrochlorothiazide<br>118.825<br>KGS)(NA)<br>1 Number<br>1<br>Hydrochlorothiazide<br>127.50 mg /<br>Tablet<br>3<br>Ramilich / Ramilich Comp / Ramipril<br>HCT ZT/ZTV 5-25mg DE/IT/HU(Net<br>Wt. Hydrochlorothiazid e . 267.500<br>KGS)(NA)<br>1 Number<br>1<br>Hydrochlorothiazide<br>255.00 mg /<br>Tablet |
Ramilich / Ramilich Comp / Ramipril<br>HCT ZT/ZTV 5-12.5mg DE/FR(Net<br>Wt.<br>Hydrochlorothiazide<br>125.000<br>KGS)(NA) |
|
|
1 Number |
|
1 |
Hydrochlorothiazide |
|
127.50 mg /<br>Tablet |
|
Ramilich / Ramilich Comp / Ramipril<br>HCT ZT/ZTV 2.5- 12.5mg DE/IT (Net |
|
|
<br> <br>1 Number |
|
1 |
Hydrochlorothiazide |
|
127.50 mg /<br>Tablet |
|
Wt.<br>Hydrochlorothiazid<br>KGS)(NA) |
|
e<br>118.825 |
|
|
|
|
|
|
|
Ramilich / Ramilich Com<br>HCT ZT/ZTV 5-25mg D |
|
p / Ramipril<br>E/IT/HU(Net |
1 Nu |
mber |
1 |
Hydrochlorothiazide |
|
255.00 mg /<br>Tablet |
|
<br>Wt. Hydrochlorothiazid e . 267.500<br>KGS)(NA) |
|
|
|
|
|
|
|
|
| RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Case No. |
112 / NC/3/MEET/Oct/202122/10 |
|
| Case Status |
Case Deferred |
|
|
|
|
| Party Name |
AARTI INDUSTRIES LTD |
|
|
|
|
| Meeting Number |
|
|
| <br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
|
| HQ File Number |
HQRNORM APPLY 00048905AM21 |
|
| RA File Number |
03AA04014090 AM21 |
|
|
|
|
| Licence No and<br>Date |
0311000415/28/12/2020 |
|
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Molecular weight and percentage yield of reaction.<br>i. |
|
|
|
|
|
|
|
|
| Case No. |
|
113 / NC/3/MEET/Oct/202122/10 |
|
|
|
| Case Status |
|
Case Approved |
|
|
|
| Party Name |
|
COMBITIC GLOBAL CAPLET PRIVATE LIMITED |
UDIN00181698AM22
| Meeting Number and<br>Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00049002AM21 |
| RA File Number |
33AA04001898 AM21 |
| Licence No and Date |
3311000032/28/12/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>CIPROFLOXACIN<br>HYDROCHLORIDE<br>TABLETS IP/BP/USP 500MG.(Each film<br>coated<br>tablet<br>contains<br>Ciprofloxacin<br>Hydrochloride<br>IP/BP/USP<br>580mg.<br>Equivalent to Ciprofloxacin 500mg.)<br>1 Number<br>1<br>CIPROFLOXACIN<br>HYDROCHLORIDE<br>555.00 mg<br>RA concerned may take further necessary action as per above decision of NC. |
|
| Case No. |
114 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
R.L.FINE CHEM PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00049028AM21 |
| RA File Number |
07AA04006399 AM21 |
| Licence No and<br>Date |
0711000171/28/12/2020 |
| Norms Committee Decision:<br>Deferred for comments of TE. |
|
| Case No. |
115 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
T & T PHARMA CARE |
UDIN00181698AM22
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00049619AM21 |
| RA File Number |
03AA04012752 AM21 |
| Licence No and<br>Date |
0311000334/29/12/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Lumicar ( Pilocarpine HCL eye drop BP 4%<br>)((Each 10 ml bottle contains Pilocarpine HCL<br>BP 0.4 gm))<br>36735.0<br>Numbers<br>1<br>Pilocarpine HCL BP<br>15.0 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
| Case No. |
Case No. |
116 / NC/3/MEET/Oct/202122/10 |
116 / NC/3/MEET/Oct/202122/10 |
116 / NC/3/MEET/Oct/202122/10 |
116 / NC/3/MEET/Oct/202122/10 |
116 / NC/3/MEET/Oct/202122/10 |
| Case Status |
|
Case Approved |
|
|
|
|
| Party Name |
|
TATVA CHINTAN PHARMA CHEM LIMITED |
|
|
|
|
| Meeting Number<br>and Date |
|
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
|
|
|
|
| HQ File Number |
|
HQRNORM APPLY 00049739AM21 |
|
|
|
|
| RA File Number |
|
34AA04001609 AM21 |
|
|
|
|
| Licence No and<br>Date |
|
3411000058/29/12/2020 |
|
|
|
|
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>ETHYL<br>TRIPHENYL<br>PHOSPHONIUM<br>BROMIDE. CAS NO. 1530-32-1 ASSAY<br>1 kg<br>1<br>TRIPHENYL PHOSPHINE CAS<br>NO: 603-35-0 ASSAY NLT 98%<br>0.743 kg |
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl. No. |
Import items |
Qty. |
|
ETHYL<br>TRIPHENYL<br>PHOSPHONIUM<br>BROMIDE. CAS NO. 1530-32-1 ASSAY |
|
<br> <br>1 kg |
1 |
TRIPHENYL PHOSPHINE CAS<br>NO: 603-35-0 ASSAY NLT 98% |
0.743 kg |
UDIN00181698AM22
NLT 99%(ETHYL TRIPHENYL PHOSPHONIUM BROMIDE. CAS NO. 1530-32-1 ASSAY NLT 99%)
| Case No.<br>117 / NC/3/MEET/Oct/202122/10 |
Case No.<br>117 / NC/3/MEET/Oct/202122/10 |
|
|
|
|
| Case Status<br>Case Approved |
|
|
|
|
|
| Party Name<br>FINE ORGANIC INDUSTRIES LIMITED |
|
|
|
|
|
| Meeting Number<br>and Date<br>NC/ 3/ MEET/ Oct/ 202122/ 10 and |
|
12/11/2021 |
|
|
|
| HQ File Number<br>HQRNORM APPLY 00050227AM21 |
|
|
|
|
|
| RA File Number<br>03AA04015431 AM21 |
|
|
|
|
|
| Licence No and<br>Date<br>0311000530/30/12/2020 |
|
|
|
|
|
| Norms Committee Decision: |
|
|
|
|
|
| The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting |
|
|
|
|
|
| No.**4/82-ALC4/2018 dated 19.06.2018 **against Advance Authorization No.0310818353 dated 09.01.2018, it was decided |
|
|
|
|
|
| to ratify adhoc norms under Para 4.07 of HBP vol. I as per details given below or as applied by the firm, whichever is less: |
|
|
|
|
|
|
Export product<br>Qty. |
Sl. |
Import items |
Qty. |
|
|
|
No. |
|
|
|
|
Glyceryl Mono Laurate (GML)<br>1 kg |
1 |
LAURIC ACID |
0.738 kg |
|
|
|
2 |
GLYCERINE |
0.339 kg |
|
| RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
| Case No. |
118 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
UDIN00181698AM22
| Party Name |
Party Name |
DANOPHARM CHEMICALS PRIVATE LIMITED |
DANOPHARM CHEMICALS PRIVATE LIMITED |
DANOPHARM CHEMICALS PRIVATE LIMITED |
DANOPHARM CHEMICALS PRIVATE LIMITED |
DANOPHARM CHEMICALS PRIVATE LIMITED |
| Meeting Number<br>and Date |
|
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
|
|
|
|
| HQ File Number |
|
HQRNORM APPLY 00051253AM21 |
|
|
|
|
| RA File Number |
|
03AA04013474 AM21 |
|
|
|
|
| Licence No and<br>Date |
|
0311000518/31/12/2020 |
|
|
|
|
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>2 2 2 Trichloro Acetophenone<br>1.45 kg<br>2<br>Imidazole<br>0.53 kg<br>3<br>Sodium Borohydride<br>0.10 kg<br>Alpha-(2,4-dichlorophenyl)-1H-<br>Imidazole-1-<br>ethanol<br>(ANTI<br>INFLAMMATORY)<br>1 kg<br>4<br>Dimethyl Suphoxide<br>0.65 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl. No. |
Import items |
Qty. |
|
Alpha-(2,4-dichlorophenyl)-1H-<br>Imidazole-1-<br>ethanol<br>(ANTI<br>INFLAMMATORY) |
|
<br>1 kg |
1 |
2 2 2 Trichloro Acetophenone |
1.45 kg |
|
|
|
|
2 |
Imidazole |
0.53 kg |
|
|
|
|
3 |
Sodium Borohydride |
0.10 kg |
|
|
|
|
4 |
Dimethyl Suphoxide |
0.65 kg |
|
|
|
|
s per above decision of NC. |
|
|
| Case No. |
119 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
DELTA FINOCHEM PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00051264AM21 |
| RA File Number |
03AA04014749 AM21 |
| Licence No and<br>Date |
0311000410/31/12/2020 |
| Norms Committee Decision:<br>Deferred for comments of TE. |
|
UDIN00181698AM22
| Case No. |
120 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
FINE ORGANIC INDUSTRIES LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00052319AM21 |
| RA File Number |
03AA04015650 AM21 |
| Licence No and<br>Date |
0311000581/01/01/2021 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting<br>No.**4/82-ALC4/2018 dated 19.06.2018 **against Advance Authorization No.0310818353 dated 09.01.2018, it was decided<br>to ratify adhoc norms under Para 4.07 of HBP vol. I 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>1<br>LAURIC ACID<br>0.738 kg<br>Glyceryl Mono Laurate (GML)<br>1 kg<br>2<br>GLYCERINE<br>0.339 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
| Case No. |
121 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
SAISONS TRADE & INDUSTRY PVT LTD |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00052352AM21 |
| RA File Number |
03AA04015368 AM21 |
| Licence No and<br>Date |
0311000545/01/01/2021 |
| Norms Committee Decision: |
|
UDIN00181698AM22
i. Stepwise complete and balanced chemical reactions, molecular weight and percentage yield on molar basis.
Material balance for the entire process.
| Case No. |
122 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
PROLIFE BIO-CHEMICAL INDUSTRIES PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00052368AM21 |
| RA File Number |
03AA04014535 AM21 |
| Licence No and<br>Date |
0311000521/01/01/2021 |
| Norms Committee Decision:<br>Deferred for comments of TE. |
|
| Case No. |
123 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
YASHO INDUSTRIES LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00053385AM21 |
| RA File Number |
03AA04015146 AM21 |
| Licence No and<br>Date |
0311000527/04/01/2021 |
| Norms Committee Decision:<br>Deferred for comments of TE. |
|
| Case No. |
124 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
UDIN00181698AM22
| Party Name |
SANDHYA ORGANIC CHEMICALS PVT LTD |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00053375AM21 |
| RA File Number |
03AA04015736 AM21 |
| Licence No and<br>Date |
0311000630/04/01/2021 |
| Norms Committee Decision:<br>Deferred for comments of TE. |
|
| Case No. |
125 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
AURORE LIFE SCIENCES PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00053377AM21 |
| RA File Number |
09AA04003174 AM21 |
| Licence No and<br>Date |
0911000111/04/01/2021 |
| Norms Committee Decision:<br>Deferred for comments of TE. |
|
| Case No. |
126 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
SAGA LIFESCIENCES LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00054927AM21 |
| RA File Number |
08AA04005731 AM21 |
| Licence No and<br>Date |
0811000286/05/01/2021 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3MEET/Sep/202122/8 dated 24.09.2021against Advance Authorization No.0810147725 dated<br>11.05.2020, it was decided to ratify adhoc norms under Para 4.07 of HBP vol. I as per details given below or as<br>applied by the firm, whichever is less: |
|
UDIN00181698AM22
| Export product |
Qty. |
Import item |
Qty. |
| DIFLAH<br>500<br>(Diosmin<br>and<br>Hesperidin Tablets 500mg) |
<br>1 Number Tablet |
DIOSMIN + HESPERIDIN 9:1<br>(Assay NMT 93% and Water content<br>NLT 2.9%) |
<br>564.29 mg |
| Case No. |
127 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
INDO AMINES LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00054949AM21 |
| RA File Number |
039404000664 AM21 |
| Licence No and<br>Date |
0311000458/05/01/2021 |
| Norms Committee Decision:<br>Deferred for comments of TE. |
|
| Case No. |
128 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
KOPRAN RESEARCH LABORATORIES LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00055252AM21 |
| RA File Number |
03AA04015651 AM21 |
| Licence No and<br>Date |
0311000668/05/01/2021 |
| Norms Committee Decision: |
|
UDIN00181698AM22
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:
| Export product |
Qty. |
Sl. No. |
Import items |
Qty. |
| AZITHROMYCIN DIHYDRATE (USP) |
1 kg |
1 |
AZITHROMYCIN AMINE |
0.9434 kg |
|
|
2 |
ACETONE |
0.90kg |
| Case No. |
129 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
TOJO VIKAS INTERNATIONAL PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00055524AM21 |
| RA File Number |
05AA04021469 AM21 |
| Licence No and<br>Date |
0511000609/05/01/2021 |
| Norms Committee Decision:<br>Deferred for comments of TE. |
|
| Case No. |
130 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
SHREYANS CHEMICALS |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00056440AM21 |
| RA File Number |
03AA04016449 AM21 |
| Licence No and<br>Date |
0311000702/06/01/2021 |
| Norms Committee Decision: |
|
UDIN00181698AM22
Deferred for comments of TE.
| Case No. |
131 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
AURORE LIFE SCIENCES PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00056445AM21 |
| RA File Number |
09AA04003615 AM21 |
| Licence No and<br>Date |
0911000133/06/01/2021 |
| Norms Committee Decision:<br>Deferred for comments of TE. |
|
| Case No. |
132 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
KAIRAV CHEMOFARBE INDUSTRIES LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00055852AM21 |
| RA File Number |
03AA04014171 AM21 |
| Licence No and<br>Date |
0311000718/06/01/2021 |
| Norms Committee Decision:<br>Deferred for comments of TE. |
|
| Case No. |
133 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
HALDIA PETROCHEMICALS LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00056201AM21 |
| RA File Number |
02AA04007088 AM21 |
UDIN00181698AM22
Licence No and 0211000149/06/01/2021 Date Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to refer the case to Department of Chemical & Petrochemicals (D/o C&PC).
| Case No. |
134 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
YASH RASAYAN & CHEMICALS |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00056208AM21 |
| RA File Number |
34AA04001756 AM21 |
| Licence No and<br>Date |
3411000089/06/01/2021 |
| Norms Committee Decision:<br>Deferred for comments of TE. |
|
| Case No. |
135 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
BENZO CHEM INDUSTRIES PVT LTD |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00056731AM21 |
| RA File Number |
039404000653 AM21 |
| Licence No and<br>Date |
0311000721/07/01/2021 |
| Norms Committee Decision:<br>Deferred for comments of TE. |
|
| Case No. |
136 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
KOPRAN RESEARCH LABORATORIES LIMITED |
| MeetingNumber |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
UDIN00181698AM22
| and Date |
|
| HQ File Number |
HQRNORM APPLY 00057063AM21 |
| RA File Number |
03AA04015653 AM21 |
| Licence No and<br>Date |
0311000731/07/01/2021 |
| Norms Committee Decision: |
|
| The Committee considered the case as per agenda and it was decided to call for following information from the firm: |
|
| Complete technical details as per Annexure to Appendix 4E. |
|
| Case No.<br>137 / NC/3/MEET/Oct/202122/10 |
Case No.<br>137 / NC/3/MEET/Oct/202122/10 |
|
|
|
|
| Case Status<br>Case Approved |
|
|
|
|
|
| Party Name<br>MICRO LABS LIMITED |
|
|
|
|
|
| Meeting Number and Date NC/ 3/ MEET/ Oct/ 202122/ |
10 and 12/11/2021 |
|
|
|
|
| HQ File Number<br>HQRNORM APPLY 00058115AM21 |
|
|
|
|
|
| RA File Number<br>07AA04006857 AM21 |
|
|
|
|
|
| Licence No and Date<br>0711000247/08/01/2021 |
|
|
|
|
|
| Norms Committee Decision: |
|
|
|
|
|
| The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP |
|
|
|
|
|
| Vol. I as per details given below or as applied by the firm, whichever is less:<br> |
|
|
|
|
|
| Sl. No. Export product |
Qty. |
Sl. No. |
Import items |
Qty. |
|
| 1<br>DICLOXACILLIN<br>250<br>MG |
1 Number |
1 |
DICLOXACILLIN |
267.50 mg |
|
| CAPSULES(BP/EP/USP/IP (32.51 KG )) |
|
|
|
|
|
|
|
|
SODIUM |
|
|
| 2<br>DICLOXACILLIN<br>500<br>MG |
1 Number |
1 |
DICLOXACILLIN |
535.00 mg |
|
| CAPSULES(BP/EP/USP/IP ( 2070 KG)) |
|
|
|
|
|
|
|
|
SODIUM |
|
|
| RA concerned may take further necessary action as per |
above decision of NC. |
|
|
|
|
UDIN00181698AM22
| Case No. |
138 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
SWISS PARENTERALS LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00058179AM21 |
| RA File Number |
08AA04006131 AM21 |
| Licence No and<br>Date |
0811000317/08/01/2021 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Master Batch Formula for the Export item.<br>i.<br>COA of import item from foreign supplier.<br>ii. |
|
| Case No. |
139 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
ZEE LABORATORIES |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00058317AM21 |
| RA File Number |
05AA04022853 AM21 |
| Licence No and<br>Date |
0511000697/08/01/2021 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>DML for the export item showing approved composition.<br>i.<br>COA of import item from foreign supplier. |
|
| Case No. |
140 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
AURORE LIFE SCIENCES PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
UDIN00181698AM22
| HQ File Number |
HQRNORM APPLY 00058376AM21 |
| RA File Number |
09AA04003607 AM21 |
| Licence No and<br>Date |
0911000131/08/01/2021 |
| Norms Committee Decision:<br>Deferred for comments of TE. |
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| Case No. |
141 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
CARENOW MEDICAL PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00059520AM21 |
| RA File Number |
322404000077 AM21 |
| Licence No and<br>Date |
3211000016/11/01/2021 |
| Norms Committee Decision:<br>The Committee considered the case as per Agenda and it was observed that the Export Product appears to be textile<br>product, which are dealt in Norms Committee-5. Hence, it was decided totransfer the case to NC-5. |
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| Case No. |
Case No. |
142 / NC/3/MEET/Oct/202122/10 |
142 / NC/3/MEET/Oct/202122/10 |
142 / NC/3/MEET/Oct/202122/10 |
142 / NC/3/MEET/Oct/202122/10 |
142 / NC/3/MEET/Oct/202122/10 |
| Case Status |
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Case Approved |
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| Party Name |
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FDC LIMITED |
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| Meeting Number<br>and Date |
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NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
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| HQ File Number |
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HQRNORM APPLY 00059713AM21 |
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| RA File Number |
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03AA04015859 AM21 |
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| Licence No and<br>Date |
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0311000791/11/01/2021 |
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| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty. |
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Export product |
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Qty. |
Sl. No. |
Import items |
Qty. |
UDIN00181698AM22
| BRIMONIDINE EYE DROPS 5ML(EYE |
1 Vial |
1 |
Brimonidine L-Tartrate |
10.20 mg |
| DROPS), 0.2% w/v |
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| Case No. |
143 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
SYNTHO CHIRALS PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00059741AM21 |
| RA File Number |
09AA04003656 AM21 |
| Licence No and<br>Date |
0911000173/11/01/2021 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>(1R,2R)-2-amino-<br>6-(4-nitrophenyl)-<br>1-<br>phenylhex-5- yn-1-ol hydrochloride (drug<br>intermediate)<br>1 kg<br>1<br>CDX-034 LYOPHILIZED<br>ENZYME POWDER<br>0.0118 kg<br>RA concerned may take further necessary action as per above decision of NC. |
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| Case No. |
144 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
AURORE LIFE SCIENCES PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
UDIN00181698AM22
| HQ File Number |
HQRNORM APPLY 00059985AM21 |
| RA File Number |
09AA04003805 AM21 |
| Licence No and<br>Date |
0911000181/11/01/2021 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Guanine<br>0.84 kg<br>Valaciclovir HCL(API)<br>1 kg<br>2<br>Dimethyl Formamide<br>3.515 kg<br>RA concerned may take further necessary action as per above decision of NC. |
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| Case No. |
Case No. |
145 / NC/3/MEET/Oct/202122/10 |
145 / NC/3/MEET/Oct/202122/10 |
145 / NC/3/MEET/Oct/202122/10 |
145 / NC/3/MEET/Oct/202122/10 |
145 / NC/3/MEET/Oct/202122/10 |
| Case Status |
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Case Approved |
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| Party Name |
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AURORE LIFE SCIENCES PRIVATE LIMITED |
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| Meeting Number<br>and Date |
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NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
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| HQ File Number |
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HQRNORM APPLY 00060002AM21 |
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| RA File Number |
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09AA04003745 AM21 |
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| Licence No and<br>Date |
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0911000180/11/01/2021 |
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| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>7-Chloro- 1,2,3,4-tetrahydro- 5H-1-Benzazepin-5-<br>one<br>0.96 kg<br>Tolvaptan (Bulk Drug)<br>1 kg |
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Export product |
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Qty. |
Sl. No. |
Import items |
Qty. |
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Tolvaptan (Bulk Drug) |
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1 kg |
1 |
7-Chloro- 1,2,3,4-tetrahydro- 5H-1-Benzazepin-5-<br>one |
0.96 kg |
UDIN00181698AM22
2 4-Nitro-2- methyl Benzoic Acid 1.00 kg
| Case No. |
146 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
ORGANIC INDIA PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00060251AM21 |
| RA File Number |
06AA04002791 AM21 |
| Licence No and<br>Date |
0611000095/11/01/2021 |
| Norms Committee Decision: |
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| The Committee considered the case as per Agenda and it was observed that the Export Product appears to be food |
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| items, which are dealt in Norms Committee-6. Hence, it was decided totransfer the case to NC-6. |
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| Case No.<br>147 / NC/3/MEET/Oct/202122/10 |
Case No.<br>147 / NC/3/MEET/Oct/202122/10 |
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| Case Status<br>Case Approved |
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| Party Name<br>SRIAM LABS PRIVATE LIMITED |
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| Meeting Number<br>and Date<br>NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
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| HQ File Number<br>HQRNORM APPLY 00060414AM21 |
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| RA File Number<br>09AA04003619 AM21 |
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| Licence No and<br>Date<br>0911000176/12/01/2021 |
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| Norms Committee Decision: |
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| The Committee considered the case as per agenda and |
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it was decided to ratify adhoc norms under Para 4.07 of HBP |
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| Vol. I as per details given below or as applied by the firm, whichever is less:<br> |
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Export product<br>Qty. |
Sl. No. |
Import items |
Qty. |
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UDIN00181698AM22
| 1<br>2-Azabicylo [2.2.1] hept- 5-en-3-one<br>(Vince lactam)<br>1.337 kg<br>2<br>Sodium borohydride<br>0.214 kg<br>3<br>L(+) Tartaric acid<br>0.90 kg<br>(1S,<br>4R)<br>–<br>Cis<br>-4-Amino-2-<br>cyclopentene-1- methanol tartrate (CAP-<br>II)(Powder)<br>1 kg<br>4<br>D (-) tartaric acid<br>0.742 kg<br>RA concerned may take further necessary action as per above decision of NC. |
(1S,<br>4R)<br>–<br>Cis<br>-4-Amino-2-<br>cyclopentene-1- methanol tartrate (CAP-<br>II)(Powder) |
<br>1 kg |
1 |
2-Azabicylo [2.2.1] hept- 5-en-3-one<br>(Vince lactam) |
<br>1.337 kg |
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2 |
Sodium borohydride |
0.214 kg |
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3 |
L(+) Tartaric acid |
0.90 kg |
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4 |
D (-) tartaric acid |
0.742 kg |
| Case No. |
148 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
SRIAM LABS PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00060415AM21 |
| RA File Number |
09AA04003617 AM21 |
| Licence No and<br>Date |
0911000177/12/01/2021 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>1 METHYL 3 PHENYL PROPYL AMINE<br>5656 kg<br>2<br>5 BROMO ACETYL SALICYLAMIDE<br>6348 kg<br>LABETALOL<br>HYDROCHLORIDE<br>(POWDER)<br>4000 kg<br>3<br>SODIUM BOROHYDRIDE<br>520 kg<br>RA concerned may take further necessary action as per above decision of NC. |
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UDIN00181698AM22
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149 / NC/3/MEET/Ot/202122/10 |
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149 / NC/3/MEET/Ot/202122/10 |
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Case Aroved |
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pp |
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| Party Name |
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SRINI PHARMACEUTICALS PRIVATE LIMITED |
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| Meetng Number<br>and Date |
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NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
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| HQ File Number |
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HQRNORM APPLY 00060915AM21 |
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| RA File Number |
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09AA04002915 AM21 |
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| Licence No and |
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| <br>Date |
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0911000179/12/01/2021 |
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| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>4, 5, 6, 7 TETRAHYDROTHIE NO<br>(3,<br>2-C)<br>PYRIDINE<br>HYDROCHORIDE CPG10<br>0.74 kg<br>2<br>METHYL ISO BUTYL KETONE<br>MIBK<br>1.092 kg<br>METHYL ALPHA- (4, 5, 6, 7-TETRAHYDRA-<br>5- THIENO (3, 2- C) PYRIDYL) (2- CHLORO-<br>PHENYL)<br>ACETATE<br>HYDROCHLORIDE<br>(CPG-20) (SOLID)<br>1 kg<br><br> <br> |
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Export product |
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Qty. |
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Sl. No. |
Import ite |
s |
Qty. |
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METHYL ALPHA- (4, 5, 6, 7-TETRAHYDRA-<br>5- THIENO (3, 2- C) PYRIDYL) (2- CHLORO-<br>PHENYL)<br>ACETATE<br>HYDROCHLORIDE<br>(CPG-20) (SOLID) |
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1 kg |
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1 |
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4, 5, 6, 7<br>(3,<br>HYDROC |
ETRAHYDROTHIE NO<br>2-C)<br>PYRIDINE<br>HORIDE CPG10 |
0.74 kg |
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2 |
METHYL |
ISO BUTYL KETONE |
1.092 kg |
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MIBK |
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| 3<br>ETHYLENE DI CHLORIDE DI<br>CHLORO ETHANE<br>0.70 kg<br>RA concerned may take further necessary action as per above decision of NC. |
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3 |
ETHYLENE DI CHLORIDE DI<br>CHLORO ETHANE |
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0.70 kg |
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| Case No. |
150 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Approved |
| Party Name |
AUROBINDO PHARMA LTD |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00060970AM21 |
UDIN00181698AM22
| RA File Number |
09AA04003815 AM21 |
| Licence No and<br>Date |
0911000186/12/01/2021 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Cefepime<br>Hydrochloride<br>(Non-Sterile)<br>826.76 kg<br>Cefepime for Injection 2000mg (Sterile mixture<br>of Cefepime Hcl and L-Arginine equivalent to<br>anhydrous Cefepime 2000mg)<br>298000<br>Vials<br>2<br>L Arginine (Non-Sterile)<br>494.78 kg<br>RA concerned may take further necessary action as per above decision of NC. |
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Case No. |
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151 / NC/3/MEET/Oct/202122/10 |
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Case Status |
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Case Approved |
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Party Name |
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AUROBINDO PHARMA LTD |
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Meeting Number<br>and Date |
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NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
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HQ File Number |
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HQRNORM APPLY 00060986AM21 |
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RA File Number |
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09AA04003810 AM21 |
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Licence No and<br>Date |
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0911000187/12/01/2021 |
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Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Cefepime Hydrochloride<br>(Non-Sterile)<br>1319.91 mg<br>Cefepime for Injection 1000 mg (Each vial<br>contains Sterile mixture of Cefepime<br>Hcl<br>and<br>L-Arginine<br>equivalent<br>to<br>1 Number<br>Vial |
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Export product |
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Qty. |
Sl. No. |
Import items |
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Qty. |
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Cefepime for Injection 1000 mg (Each vial<br>contains Sterile mixture of Cefepime<br>Hcl<br>and<br>L-Arginine<br>equivalent<br>to |
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<br> <br> <br>1 Number<br>Vial |
1 |
Cefepime Hydrochloride<br>(Non-Sterile) |
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1319.91 mg |
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Case No. |
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151 / NC/3/MEET/Oct/202122/10 |
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Case Status |
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Case Approved |
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Party Name |
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AUROBINDO PHARMA LTD |
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Meeting Number<br>and Date |
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NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
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HQ File Number |
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HQRNORM APPLY 00060986AM21 |
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RA File Number |
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09AA04003810 AM21 |
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Licence No and<br>Date |
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0911000187/12/01/2021 |
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Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Cefepime Hydrochloride<br>(Non-Sterile)<br>1319.91 mg<br>Cefepime for Injection 1000 mg (Each vial<br>contains Sterile mixture of Cefepime<br>Hcl<br>and<br>L-Arginine<br>equivalent<br>to<br>1 Number<br>Vial |
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Export product |
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Qty. |
Sl. No. |
Import items |
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Qty. |
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Cefepime for Injection 1000 mg (Each vial<br>contains Sterile mixture of Cefepime<br>Hcl<br>and<br>L-Arginine<br>equivalent<br>to |
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<br> <br> <br>1 Number<br>Vial |
1 |
Cefepime Hydrochloride<br>(Non-Sterile) |
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1319.91 mg |
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The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:
UDIN00181698AM22
Anhydrous cefepime 1000mg.) 2 L Arginine (Non-Sterile) 789.92 mg
| Case No. |
Case No. |
Case No. |
152 / NC/3/MEET/Oct/202122/10 |
152 / NC/3/MEET/Oct/202122/10 |
152 / NC/3/MEET/Oct/202122/10 |
152 / NC/3/MEET/Oct/202122/10 |
152 / NC/3/MEET/Oct/202122/10 |
| Case Status |
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Case Approved |
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| Party Name |
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USV PRIVATE LIMITED |
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| Meeting Number<br>and Date |
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NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
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| HQ File Number |
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HQRNORM APPLY 00061090AM21 |
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| RA File Number |
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03AA04015636 AM21 |
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| Licence No and<br>Date |
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0311000899/12/01/2021 |
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| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Perphenazine Tablets USP 2 Mg 100<br>S((5,550 Bottles x 100 Tablets Per<br>Bottle = 5,55,000 Tablets) (Net Content<br>Weight = 1.110 Kgs))<br>1 Tablet<br>1<br>Perphenazine USP<br>2.04 mg /<br>2mg Tablet<br>2<br>Perphenazine Tablets USP 4 Mg 100<br>S((11,640 Bottles x 100 Tablets Per<br>Bottle = 11,64,000 Tablets) (Net<br>Content Weight = 4.656 Kgs))<br>1 Tablet<br>1<br>Perphenazine USP<br>4.08 mg /<br>4 mg Tablet<br>3<br>Perphenazine Tablets USP 8 Mg 100<br>S((96,000 Bottles x 100 Tablets Per<br>Bottle = 96,00,000 Tablets) (Net<br>Content Weight = 76.800 Kgs))<br>1 Tablet<br>1<br>Perphenazine USP<br>8.16 mg /<br>8 mg Tablet<br>Perphenazine Tablets USP 16 Mg 100<br>16.32 mg /<br>4<br>1 Tablet<br>1<br>Perphenazine USP |
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Sl. No. |
Export product |
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Qty. |
Sl. No. |
Import items |
Qty. |
|
1 |
Perphenazine Tablets USP 2 Mg 100<br>S((5,550 Bottles x 100 Tablets Per<br>Bottle = 5,55,000 Tablets) (Net Content<br>Weight = 1.110 Kgs)) |
|
1 Tablet |
1 |
Perphenazine USP |
2.04 mg /<br>2mg Tablet |
|
2 |
Perphenazine Tablets USP 4 Mg 100<br>S((11,640 Bottles x 100 Tablets Per<br>Bottle = 11,64,000 Tablets) (Net<br>Content Weight = 4.656 Kgs)) |
|
1 Tablet |
1 |
Perphenazine USP |
4.08 mg /<br>4 mg Tablet |
|
3 |
Perphenazine Tablets USP 8 Mg 100<br>S((96,000 Bottles x 100 Tablets Per<br>Bottle = 96,00,000 Tablets) (Net<br>Content Weight = 76.800 Kgs)) |
|
1 Tablet |
1 |
Perphenazine USP |
8.16 mg /<br>8 mg Tablet |
|
4 |
Perphenazine Tablets USP 16 Mg 100 |
|
1 Tablet |
1 |
Perphenazine USP |
16.32 mg / |
UDIN00181698AM22
|
S((11,600 Bottles x 100 Tablets Per |
|
|
|
16 mg Tablet |
|
Bottle = 11,60,000 Tablets) (Net |
|
|
|
|
|
Content Weight = 18.560 Kgs)) |
|
|
|
|
| Case No. |
153 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
BALAJI AMINES LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00060368AM21 |
| RA File Number |
31AA04005070 AM21 |
| Licence No and<br>Date |
3111000082/12/01/2021 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Percentage yield in the reaction.<br>i.<br>Catalogue and specific name of catalyst to be imported.<br>ii. |
|
| Case No. |
154 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
WEXFORD LABORATORIES PRIVATE LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00061198AM21 |
| RA File Number |
07AA04006165 AM21 |
| Licence No and<br>Date |
0711000260/12/01/2021 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm: |
|
UDIN00181698AM22
| Case No. |
155 / NC/3/MEET/Oct/202122/10 |
| Case Status |
Case Deferred |
| Party Name |
BALAJI AMINES LIMITED |
| Meeting Number<br>and Date |
NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number |
HQRNORM APPLY 00060369AM21 |
| RA File Number |
31AA04005050 AM21 |
| Licence No and<br>Date |
3111000081/12/01/2021 |
| Norms Committee Decision: |
|
| The Committee considered the case as per agenda and it was decided to call for following information from the firm: |
|
| Percentage yield in the reaction.<br>i. |
|
| Catalogue and specific name of catalyst to be imported.<br>ii. |
|
| Case No.<br>156 / NC/3/MEET/Oct/202122/10 |
| Case Status<br>Case Deferred |
| Party Name<br>OPTRIX LABORATORIES PRIVATE LIMITED |
| Meeting Number<br>and Date<br>NC/ 3/ MEET/ Oct/ 202122/ 10 and 12/11/2021 |
| HQ File Number<br>HQRNORM APPLY 00061488AM21 |
| RA File Number<br>09AA04003184 AM21 |
| Licence No and<br>Date<br>0911000114/13/01/2021 |
| Norms Committee Decision: |
| The Committee considered the case as per agenda and it was decided to call for following information from the firm: |
| Complete and balanced chemical reactions showing recovery of by-products and their sale value.<br>i. |
| Technical justifications for molar requirement of import item No. 2 and 4.<br>ii. |
| Percentage yield on molar basis for each step.<br>iii. |
UDIN00181698AM22
Meeting ended with thanks to Chair and participants
No analysis has been generated for this document yet.