DGFT Minutes
In force — no superseding record on file.
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Government of India / भारत सरकार
Ministry of Commerce and Industry / वािणज्य और उद्योग मंत्रालय Department of Commerce / वािणज्य िवभाग Directorate General of Foreign Trade, Delhi / िवदेश व्यापार महािनदेशालय, िदल्ली
VANIJYA BHAWAN, AKBAR ROAD, CENTRAL DELHI, DELHI, 110011 / वािणज्य भवन, अकबर रोड, नई िदल्ली Email Office : dgft@nic.in , Phone Office : 011-23062777
MINUTES OF THE NORMS COMMITTEE- III
MEETING No. NC/3/MEET/Jun/202425/5 DATED: 14/06/2024
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.
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IV. RAs shall ensure compliance of SION, General Notes and Chapter Notes wherever applicable.
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V. RAs shall also ensure that authorization is issued or redeemed based on the wastages/consumption as ratified by the Committee or as per wastages claimed in the application, whichever is less. In this regard, full compliance of the provisions of Para 4.12 of FTP, Para 4.16; Para 4.21; and Para 4.51 of HBP shall be made
ee or as per wastages claimed in the application, whichever is less. In this regard, full compliance of the provisions of Para 4.12 of FTP, Para 4.16; Para 4.21; and Para 4.51 of HBP shall be made
Meeting No. NC/3/MEET/Jun/202425/5 dated 14/06/2024 of Norms Committee - III for the year 2024-25 was held on 14/06/2024 under the Chairmanship of Shri Rakesh Kumar,Additional DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2023.
The following members were present in the meeting:-
| S.No. | Name and Designation of Representatives | Department |
|---|---|---|
| 1 | Shri Rakesh Kumar, Addl. DGFT | DGFT(HQ) |
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| 2 | Shri Raman Kumar,Deputy DGFT | DGFT(HQ) | |
|---|---|---|---|
| 3 | Shri Dinesh Narain Mathur, Technical Expert | Consultant (Pharma) | |
| 4 | Shri Shaish Kumar, Technical Expert | Consultant (Chemical) | |
| 5 | Shri Nand Lal, Technical Expert | (Consultant (Chemical) | |
| 6 | Shri Uttam Dey Sarkar, ASO | DGFT (HQ) |
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Case Details and Decision(s):
| Case No. | 1 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Approved |
| Party Name | MANGALAM DRUGS AND ORGANICS LIMITED |
| Meeting Number and<br>Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM APPLY 00008586AM24 |
| RA File Number | NA |
| Licence No and Date | NA |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>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. No.<br>Import Items<br>Qty. allowed.<br>1<br>4,6 Dichloro 5-Methoxy Pyrimidine<br>(DCMP)<br>0.78 kg.<br>2<br>SULFANILAMIDE<br>0.90 kg.<br>3<br>Diethyl oxalate<br>Not shown in<br>process.<br>SULFADOXINE<br>1 kg.<br>4<br>DIMETHYL FORMAMIDE (DMF)<br>1.00 kg.<br>RA concerned may take further necessary action as per above decision of NC. |
| Case No. | 2 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Approved |
| Party Name | MANGALAM DRUGS AND ORGANICS LIMITED |
| Meeting Number and<br>Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM APPLY 00008231AM24 |
| RA File Number | NA |
| Licence No and Date | NA |
| Norms Committee Decision: |
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The Committee considered the case as per agenda and it was decided to fix ad-hoc 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 considered the case as per agenda and it was decided to fix ad-hoc 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. allowed. |
|---|---|---|---|---|
| SULFADOXINE | 1 kg. | 1 | 4,6 Dichloro 5-Methoxy Pyrimidine<br>(DCMP) | 0.78 kg. |
| 2 | SULFANILAMIDE | 0.90 kg. | ||
| 3 | Diethyl oxalate | Not shown in<br>process. |
RA concerned may take further necessary action as per above decision of NC.
| Case No. | 3 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | BIOLOGICAL E. LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM APPLY 00007891AM24 |
| RA File Number | NA |
| Licence No and<br>Date | NA |
| Norms Committee Decision:<br>The case is under consideration for want of comments of Deptt. of Bio-Technology. Reminder issued. |
| Case No. | 4 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Approved |
| Party Name | GREEN PINE INDUSTRIES |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
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4 / NC/3/MEET/Jun/202425/5| |---|---| |Case Status|Case Approved| |Party Name|GREEN PINE INDUSTRIES| |Meeting Number<br>and Date|NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024|
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| HQ File Number | HQRNORM APPLY 00006239AM24 |
|---|---|
| RA File Number | NA |
| Licence No and<br>Date | NA |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>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. No.<br>Import Items<br>Qty. allowed.<br>BETA PINENE<br>1 kg.<br>1<br>Gum Turpentine oil<br>1.15 kg.<br>RA concerned may take further necessary action as per above decision of NC. |
| Case No. | 5 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | KOPRAN RESEARCH LABORATORIES LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM APPLY 00004206AM24 |
| RA File Number | NA |
| Licence No and<br>Date | NA |
| Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was observed<br>that during the Personal Hearing held on 16/05/2024, the firm was advised to furnish the following<br>information/documents, however, the same still not received from the firm. |
and it was observed<br>that during the Personal Hearing held on 16/05/2024, the firm was advised to furnish the following<br>information/documents, however, the same still not received from the firm. Therefore, it was decided that<br>the firm may be again advised to furnish the following documents as sought earlier:<br>Complete batch chemical reaction showing description of export and import item along with<br>percentage yield on molar basis.<br>1.<br>Certificate of Analysis (CoA) of import item to explain the complete description of import item<br>No.1<br>2.||
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| Case No. | 6 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Approved |
| Party Name | SATYAJIT CHEMICALS PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM APPLY 00005534AM24 |
| RA File Number | NA |
| Licence No and<br>Date | 0310786462/07/07/2014 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.2/82-ALC4/2018 dated 16/05/2018against advance authorization<br>No.0310811095 dated 09/02/2017, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl. |
09/02/2017**, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>allowed.<br>EDTA Ferric Sodium<br>[ EDTA Fe ]<br>1 kg.<br>1<br>Ethylene Diamine Tetra Acetic<br>Acid (EDTA)<br>0.730 kg.<br>RA concerned may take further necessary action as per above decision of NC.||
| Case No. | 7 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | BELOORBAYIR BIOTECH LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00007896AM24 |
| RA File Number | 072404000347 AM16 |
| Licence No and<br>Date | 0710109255/12/01/2016 |
| Norms Committee Decision: |
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The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it was decided to call for following information/documents from the firm:-
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Content of API is not mentioned in export item No. 2 and 3.
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No Drug Manufacturering Licence (DML) given for export item No. 12.
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Certificate of Analysis (CoA) for import item No.1 is not given in support of its specification.
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Description of import item No. 2 and 3 not matching with CoA of actual import.
.**
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Certificate of Analysis (CoA) for import item No.1 is not given in support of its specification.
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Description of import item No. 2 and 3 not matching with CoA of actual import.
| Case No. | 8 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Rejected |
| Party Name | BELOORBAYIR BIOTECH LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00007908AM24 |
| RA File Number | 072404000160 AM17 |
| Licence No and<br>Date | 0710110226/08/08/2016 |
| Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, it was decided toreject<br>the case maintaining thestatus quo. |
| Case No. | 9 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Rejected |
| Party Name | BELOORBAYIR BIOTECH LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00007894AM24 |
| RA File Number | 072404000182 AM17 |
| Licence No and<br>Date | 0710110335/30/08/2016 |
| Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, it was decided toreject<br>the case maintaining thestatus quo. |
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Hence, it was decided toreject<br>the case maintaining thestatus quo.||
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| Case No. | 10 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | CIPLA LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00000261AM24 |
| RA File Number | 039404000617 AM17 |
| Licence No and<br>Date | 0310808312/06/10/2016 |
| Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite their comments. |
| Case No. | 11 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Rejected |
| Party Name | BELOORBAYIR BIOTECH LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00007903AM24 |
| RA File Number | 072404000273 AM17 |
| Licence No and<br>Date | 0710110770/09/12/2016 |
| Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, it was decided toreject<br>the case maintaining thestatus quo. |
| Case No. | 12 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Rejected |
| Party Name | BELOORBAYIR BIOTECH LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00007898AM24 |
| RA File Number | 072404000374 AM17 |
| Licence No and | 0710111126/14/02/2017 |
IMITED| |Meeting Number<br>and Date|NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024| |HQ File Number|HQRNORM REVIW00007898AM24| |RA File Number|072404000374 AM17| |Licence No and|0710111126/14/02/2017|
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Date
Norms Committee Decision:
The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm has not provided any technical justification / information for enhancement. Hence, it was decided to reject the case maintaining the status quo.
| Case No. | 13 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | CIPLA LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00000263AM24 |
| RA File Number | 039404001181 AM17 |
| Licence No and<br>Date | 0310812323/03/04/2017 |
| Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite their comments. |
| Case No. | 14 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | CIPLA LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00000262AM24 |
| RA File Number | 039404000295 AM18 |
| Licence No and<br>Date | 0310814908/31/07/2017 |
| Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite their comments. |
| Case No. | 15 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Approved |
| Party Name | AETHER INDUSTRIES LIMITED |
e is under consideration and TE was requested to expedite their comments.**||
| Case No. | 15 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Approved |
| Party Name | AETHER INDUSTRIES LIMITED |
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| Meeting Number and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
|---|---|
| HQ File Number | HQRNORM REVIW00008734AM24 |
| RA File Number | 522404000036 AM18 |
| Licence No and Date | 5210042414/23/10/2017 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>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>allowed.<br>1<br>PARA CHLORO PHENOL<br>2.40 kg.<br>2<br>TETRAHYDRO FURAN<br>1.00 kg.<br>3<br>MEGNESSIUM TURNINGS<br>0.40 kg.<br>4<br>ETHYLENE OXIDE<br>0.60 kg.<br>4-(2-HYDROXYETHYL)<br>PHENOL<br>1 kg.<br>5<br>2-METHYL<br>TETRAHYDROFURAN<br>0.80 kg.<br>RA concerned may take further necessary action as per above decision of NC. |
| Case No. | 16 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | CIPLA LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00000265AM24 |
| RA File Number | 039404000822 AM18 |
| Licence No and<br>Date | 0310818765/30/01/2018 |
| Norms Committee Decision: |
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The case is under consideration and TE was requested to expedite their comments.
| Case No. | 17 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Approved |
| Party Name | AETHER INDUSTRIES LIMITED |
| Meeting Number and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00008733AM24 |
| RA File Number | 522404000016 AM19 |
| Licence No and Date | 5210042638/10/05/2018 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>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. No. Import Items<br>Qty. allowed.<br>1<br>2,6-DIETHYL-4-METHYL<br>ANILINE.<br>1.362 kg.<br>2<br>SODIUM TERT BUTOXIDE<br>1.734 kg.<br>3<br>PALLADIUM(II)DICHLORIDE<br>0.0007 kg.<br>4<br>N-METHYL-2 PYRROLIDONE<br>2.15 kg.<br>8-(2,6-DIETHYL-4-<br>METHYLPHENYL)DIHYDRO-<br>1H-PYRAZOLO[1,2-<br>D][1,4,5]OXADIAZEPINE-<br>7,9(2H,8H)- DIONE (M-316).<br>1 kg.<br>5<br>TETRAHYDROFURAN<br>3.90 kg.<br>RA concerned may take further necessary action as per above decision of NC. |
| Case No. | 18 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | SHREE BANKEY BEHARI LAL FLAVORS |
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ecessary action as per above decision of NC.||
| Case No. | 18 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | SHREE BANKEY BEHARI LAL FLAVORS |
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| Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 | ||||||
|---|---|---|---|---|---|---|
| HQ File Number<br>HQRNORM REVIW00006890AM24 | ||||||
| RA File Number<br>052404000067 AM19 | ||||||
| Licence No and<br>Date<br>0510406412/10/05/2018 | ||||||
| Norms Committee Decision: | ||||||
| The case is under consideration and CLA, New Delhi | was | requested vide DGFT (HQ) letter | ||||
| No.01/82/0007/AM-25/DES-III/31<br>dated<br>11/06/2024 | to | audit | the | firm | and | <br>submit |
| production/consumption data for the year 2018-19 as sought by TE within fifteen days of | receipt of | |||||
| said letter. |
| Meeting Number | Meeting Number | Meeting Number | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| and Date | |||||||||||
| HQ File Number | HQRNORM REVIW00006890AM24 | ||||||||||
| RA File Number | 052404000067 AM19 | ||||||||||
| Licence No and<br>Date | 0510406412/10/05/2018 | ||||||||||
---|---| |and Date|||||||||||| |HQ File Number|||HQRNORM REVIW00006890AM24||||||||| |RA File Number|||052404000067 AM19||||||||| |Licence No and<br>Date|||0510406412/10/05/2018||||||||| ||||||||||||| |Norms Committee Decision:<br>The case is under consideration and CLA, New Delhi was requested vide DGFT (HQ) letter<br>No.01/82/0007/AM-25/DES-III/31<br>dated<br>11/06/2024<br>to<br>audit<br>the<br>firm<br>and<br>submit<br>production/consumption data for the year 2018-19 as sought by TE within fifteen days of receipt of|||||||||||| |said letter.|||||||||||| ||||||||||||| ||||||||||||| ||||||||||||| ||||||||||||| ||||||||||||| |Case No.|||19 / NC/3/MEET/Jun/202425/5||||||||| |Case Status|||Case Approved||||||||| |Party Name|||GLENMARK PHARMACEUTICALS LIMITED||||||||| |Meeting Number<br>and Date|||NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024||||||||| |HQ File Number|||HQRNORM REVIW00006968AM23||||||||| |RA File Number|||039404000258 AM19||||||||| |Licence No and<br>Date|||0310821966/27/06/2018||||||||| |Nor<br>T<br>c|ms Committee Decision:<br>||||||||||| ||he Committee considered the case as per agen<br>omments and no change in the import quantity.|||a and it||was deci|ded to add export item No.7|||in the previous|| ||||||||||||| ||Sl.<br>No.|Export Product||||Qty.||Sl. No.|Import Items||**Qty.
ge in the import quantity.|||a and it||was deci|ded to add export item No.7|||in the previous|| ||||||||||||| ||Sl.<br>No.|Export Product||||Qty.||Sl. No.|Import Items||Qty. allowed.| ||||||||||||| ||1|Calcipotrene Ointment 60gm Taro (C<br>Ointment USP 0.005%) ( Pack Size 60g||alcitrene<br>m)|<br>|30000 Pa|cks|1|Calcipotriol<br>Anhydrous||2.2664 kg.| ||||||||||||| ||2|CALCITRENE OINTMENT 0.005%||10X5|<br>|75000 Pa|cks||||| |||GM (Calcitrene Ointment USP 0.005%) (Pack<br>Size 5gm)|||||||||| ||3|CALCITRENE OINTMENT 0005% 60 GM|||<br>28000 Packs||||||| |||.<br>(Calcitrene Ointment USP 0.005%) ( Pack Size<br>60gm)|||<br> <br>|||||||
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| 4<br>Calcipotriene<br>Ointment<br>120gm<br>Taro<br>(Calcitrene Ointment USP 0.005%) ( Pack Size<br>120gm)<br>75000 Packs<br>5<br>Calcitrene Ointment 120gm Taro (Calcitrene<br>Ointment USP 0.005%) (Pack Size 120gm)<br>45000 Packs<br>6<br>Calcipotriene Cream 0.005% 60gm (Calcitrene<br>Cream USP 0.005%) ( Pack Size 60gm)<br>80000 Packs<br>7<br>Calcipotriene<br>Cream<br>0.005%<br>120gm<br>(Calcitrene Cream USP 0.005%) ( Pack Size<br>120gm)<br>150000<br>Packs<br>RA concerned may take further necessary action as per above decision of NC. | 4 | Calcipotriene<br>Ointment<br>120gm<br>Taro<br>(Calcitrene Ointment USP 0.005%) ( Pack Size<br>120gm) | <br> <br>75000 Packs | |||
|---|---|---|---|---|---|---|
| 5 | Calcitrene Ointment 120gm Taro (Calcitrene<br>Ointment USP 0.005%) (Pack Size 120gm) | <br>45000 Packs |
t USP 0.005%) ( Pack Size<br>120gm)|<br> <br>75000 Packs|||| |---|---|---|---|---|---|---| ||5|Calcitrene Ointment 120gm Taro (Calcitrene<br>Ointment USP 0.005%) (Pack Size 120gm)|<br>45000 Packs|||| ||6|Calcipotriene Cream 0.005% 60gm (Calcitrene<br>Cream USP 0.005%) ( Pack Size 60gm)|<br>80000 Packs|||| ||7|Calcipotriene<br>Cream<br>0.005%<br>120gm<br>(Calcitrene Cream USP 0.005%) ( Pack Size<br>120gm)|<br> <br>150000<br>Packs||||
| Case No. | Case No. | 20 / NC/3/MEET/Jun/202425/5 | 20 / NC/3/MEET/Jun/202425/5 | 20 / NC/3/MEET/Jun/202425/5 | 20 / NC/3/MEET/Jun/202425/5 | 20 / NC/3/MEET/Jun/202425/5 |
|---|---|---|---|---|---|---|
| Case Status | Case Approved | |||||
| Party Name | BALAJI AMINES LIMITED | |||||
| Meeting Number and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 | |||||
| HQ File Number | HQRNORM REVIW00001088AM24 | |||||
| RA File Number | 318304000082 AM19 | |||||
| Licence No and Date | 3110067147/20/08/2018 | |||||
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>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. allowed.<br>1<br>AMMONIA ANHYDROUS<br>0.250 kg.<br>2- PYRROLIDONE<br>1 kg.<br>2<br>GAMMA BUTYROLACTONE<br>1.265 kg. | ||||||
| Export Product | Qty. | Sl.<br>No. | Import Items | Qty. allowed. | ||
| 2- PYRROLIDONE | 1 kg. | 1 | AMMONIA ANHYDROUS | 0.250 kg. | ||
| 2 | GAMMA BUTYROLACTONE | 1.265 kg. | ||||
13
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t**||Qty.|Sl.<br>No.|Import Items|Qty. allowed.| ||2- PYRROLIDONE||1 kg.|1|AMMONIA ANHYDROUS|0.250 kg.| |||||2|GAMMA BUTYROLACTONE|1.265 kg.| ||||||||
13
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| Case No. | 21 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Approved |
| Party Name | VINS BIOPRODUCTS LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00007011AM24 |
| RA File Number | 092404000363 AM19 |
| Licence No and<br>Date | 0910066851/14/11/2018 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>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>allowed.<br>Tetanus<br>Antitoxin<br>IHS/BP<br>1000IU / 1500IU - PFS / VIALS/<br>Ampoules<br>100000<br>Vials<br>1<br>Tetanus Antitoxin 3000IU/ML<br>57 Liter<br>RA concerned may take further necessary action as per above decision of NC. |
| Case No. | 22 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Withdrawn |
| Party Name | TATA CHEMICALS LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | 018205001646AM19 |
| RA File Number | 039504000901 AM19 |
| Licence No and<br>Date | 0310825645/13/12/2018 |
14
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Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that Norms Committee-3 in its Meeting No. NC/3/MEET/Aug/202122/7 dated 13/08/2021 has already decided to transfer the case to Norms Committee-6 as the export product – Fossence (Oligofructose/FOS) Poweder P 90/Liquid L95 comes under Food category, not Pharmaceutical. Therefore, Committee decided to close the case.
| Case No. | Case No. | 23 / NC/3/MEET/Jun/202425/5 | 23 / NC/3/MEET/Jun/202425/5 | 23 / NC/3/MEET/Jun/202425/5 | 23 / NC/3/MEET/Jun/202425/5 | 23 / NC/3/MEET/Jun/202425/5 |
|---|---|---|---|---|---|---|
| Case Status | Case Approved | |||||
| Party Name | CIPLA LIMITED | |||||
| Meeting Number | ||||||
| <br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 | |||||
| HQ File Number | HQRNORM REVIW00000260AM24 | |||||
| RA File Number | 039404000753 AM19 | |||||
| Licence No and | ||||||
| Date | 0310825758/18/12/2018 | |||||
| Norms Committee | Decision: | |||||
| The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- | ||||||
| Export Product | Qty. | Sl.<br>No. | Import Items | **Qty. |
ms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||||||| |||||||| ||Export Product||Qty.|Sl.<br>No.|Import Items|Qty. allowed.| |||||||| ||Efavirenz 60<br>|0 mg, Lamivudine<br>|1 Number<br>|1|Efavirenz|612.0 mg.| ||300 mg, Ten<br>|ofovir Disoproxil<br>|Tablet|||| |||||||| ||Fumarate 30<br>Tablet contai<br>|mg Tablets (Each<br>ns: Efavirenz 600<br>||2|Lamivudine|306.0 mg.| ||mg, Tenofov<br>|ir Disoproxil<br>||||| ||Fumarate 30<br>|mg, Lamivudine<br>||3|Tenofovir Disoproxil<br>|306.0 mg.| ||300 mg Tabl|ets)|||Fumarate|| |||||||| |||||4|Croscarmellose Sodium<br>(AC-DI-SOL) NF|123.0 mg.| |||||||| |||||5|Microcrystalline Cellulose<br>NF<br>(Avicel PH 101)|<br>297.6 mg.| ||||||||
| Case No. | Case No. | 23 / NC/3/MEET/Jun/202425/5 | 23 / NC/3/MEET/Jun/202425/5 | 23 / NC/3/MEET/Jun/202425/5 | 23 / NC/3/MEET/Jun/202425/5 | 23 / NC/3/MEET/Jun/202425/5 |
|---|---|---|---|---|---|---|
| Case Status | Case Approved | |||||
| Party Name | CIPLA LIMITED | |||||
| Meeting Number | ||||||
| <br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 | |||||
| HQ File Number | HQRNORM REVIW00000260AM24 | |||||
| RA File Number | 039404000753 AM19 | |||||
| Licence No and | ||||||
| Date | 0310825758/18/12/2018 | |||||
| Norms Committee | Decision: | |||||
| The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. |
No and||||||| |Date||0310825758/18/12/2018||||| |Norms Committee||Decision:||||| |The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||||||| |||||||| ||Export Product||Qty.|Sl.<br>No.|Import Items|Qty. allowed.| |||||||| ||Efavirenz 60<br>|0 mg, Lamivudine<br>|1 Number<br>|1|Efavirenz|612.0 mg.| ||300 mg, Ten<br>|ofovir Disoproxil<br>|Tablet|||| |||||||| ||Fumarate 30<br>Tablet contai<br>|mg Tablets (Each<br>ns: Efavirenz 600<br>||2|Lamivudine|306.0 mg.| ||mg, Tenofov<br>|ir Disoproxil<br>||||| ||Fumarate 30<br>|mg, Lamivudine<br>||3|Tenofovir Disoproxil<br>|306.0 mg.| ||300 mg Tabl|ets)|||Fumarate|| |||||||| |||||4|Croscarmellose Sodium<br>(AC-DI-SOL) NF|123.0 mg.| |||||||| |||||5|Microcrystalline Cellulose<br>NF<br>(Avicel PH 101)|<br>297.6 mg.| ||||||||
15
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| 6<br>Magnesium Stearate NF<br>(Vegetable Grade)<br>17.0 mg.<br>7<br>Hydroxy Propyl Cellulose<br>NF (Klucel LF)<br>38.4 mg.<br>8<br>Lactose for DC<br>(Tablettose 80/Super Tab)<br>BP/PH Eur<br>199.60 mg.<br>9<br>Silica Gel bags 3 GM<br>Stripax R/F<br>Relevant packing<br>material net to<br>net.<br>RA concerned may take further necessary action as per above decision of NC. | 6 | Magnesium Stearate NF<br>(Vegetable Grade) | 17.0 mg. | ||
|---|---|---|---|---|---|
| 7 | Hydroxy Propyl Cellulose<br>NF (Klucel LF) | 38.4 mg. | |||
| 8 | Lactose for DC<br>(Tablettose 80/Super Tab)<br>BP/PH Eur | 199.60 mg. |
arate NF<br>(Vegetable Grade)|17.0 mg.| |---|---|---|---|---|---| ||||7|Hydroxy Propyl Cellulose<br>NF (Klucel LF)|38.4 mg.| ||||8|Lactose for DC<br>(Tablettose 80/Super Tab)<br>BP/PH Eur|199.60 mg.| ||||9|Silica Gel bags 3 GM<br>Stripax R/F|Relevant packing<br>material net to<br>net.|
| Case No. | 24 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | CIPLA LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00007594AM24 |
| RA File Number | 039404001019 AM19 |
| Licence No and<br>Date | 0310827414/01/03/2019 |
| Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to<br>call the firm for attendingPersonal Hearing<br>before Norms Committee to explain its case along with<br>following information / documents and proper justification of import items.<br>Copy of amended Advance Authorisation in support of additional export and import items. |
16
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ollowing information / documents and proper justification of import items.<br>Copy of amended Advance Authorisation in support of additional export and import items.||
16
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| Case No. | 25 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Approved |
| Party Name | CLEAN SCIENCE AND TECHNOLOGY LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00000154AM24 |
| RA File Number | 318304000044 AM20 |
| Licence No and<br>Date | 3110067449/20/06/2019 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>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. No. Import Items<br>Qty. allowed.<br>1<br>Phenol<br>1.012 kg.<br>2<br>Methanol<br>0.396 kg.<br>3<br>Hydrogen Peroxide PURITY 60%<br>0.80 kg.<br>Guaiacol<br>1 kg.<br>4<br>Acetone (Solvent)<br>0.14 kg.<br>RA concerned may take further necessary action as per above decision of NC. |
| Case No.<br> | 26 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status<br> | Case Deferred |
| Party Name<br> | CONCORD BIOTECH LIMITED |
| Meeting Number<br>and Date<br> | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number<br> | HQRNORM REVIW00008666AM24 |
| RA File Number<br> | 082404000101 AM20 |
| Licence No and<br>Date<br> | 0810145581/27/06/2019 |
| Norms Committee Decision: |
17
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2024| |HQ File Number<br>|HQRNORM REVIW00008666AM24| |RA File Number<br>|082404000101 AM20| |Licence No and<br>Date<br>|0810145581/27/06/2019| |Norms Committee Decision:||
17
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The committee considered the request of firm for review/fixation of ad-hoc norms and it was observed that during the Personal Hearing held on 16/05/2024, the firm was advised to furnish the following information/documents, however, the same still not received from the firm. Therefore, it was decided that the firm may be again advised to furnish the following documents as sought earlier:
-
I. Molecular weight of input and output products.
-
II. Percentage yield on molar basis with technical justification.
-
III. Revised GST certificate to account for entire balanced quantity.
| The committee | The committee | considered the request of firm for review/fixation of ad-hoc norms and it was observed | considered the request of firm for review/fixation of ad-hoc norms and it was observed | considered the request of firm for review/fixation of ad-hoc norms and it was observed | considered the request of firm for review/fixation of ad-hoc norms and it was observed | considered the request of firm for review/fixation of ad-hoc norms and it was observed |
|---|---|---|---|---|---|---|
| that during the Personal Hearing held on 16/05/2024, the firm was advised to furnish the following<br>information/documents, however, the same still not received from the firm. |
|---|---|---|---|---| |that during the Personal Hearing held on 16/05/2024, the firm was advised to furnish the following<br>information/documents, however, the same still not received from the firm. Therefore, it was decided that<br>the firm may be again advised to furnish the following documents as sought earlier:||||||| |Molecular weight of input and output products.<br>I.<br>Percentage yield on molar basis with technical justification.<br>II.<br>Rid GST ifi f i bld i<br>||||||| |evse<br>III.||certcate to account or entre aance quantty.||||| |||||||| |||||||| |||||||| |||||||| |||||||| |Case No||27 / NC/3/MEET/Jun/202425/5||||| |.||||||| |Case Status||Case Approved||||| |||||||| |Party Name||SYNTHO CHIRALS PRIVATE LIMITED||||| |Mi Nb||||||| |eetng umer<br>and Date||NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024||||| |HQ File Number||HQRNORM REVIW00000545AM25||||| |RA File Number||092404000172 AM20||||| |Licence No and<br>Date||0910067749/03/07/2019||||| |Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same<br>export product/import product in meetingNo.NC/3/MEET/Jan/202324/20 dated 18/01/2024against<br>advance authorizationNo.0318830783 dated N/A, it was decided to fix ad-hoc norms under Para 4.07<br>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.
oc norms under Para 4.07<br>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. allowed.| ||(1R,2R)-2-amino-6-(4-nitrophenyl)-1-||1 kg.|1|KRED LYOPHILIZED|0.014 kg.| ||phenylhex-5-<br>|yn-1-ol hydrochloride of<br>|||ENZYME POWDER|| ||Aminoalcoho|l||||| |||||||| |||||||| |||||||| |RA concerned may||take further necessary action as per above decision of NC.||||| |||||||| |||||||| |||||||| ||||||||
18
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| Case No. | 28 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | AVIK PHARMACEUTICAL LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00008637AM24 |
| RA File Number | 039404000497 AM20 |
| Licence No and<br>Date | 0310831894/27/09/2019 |
| Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite their comments. |
| Case No.<br> | 29 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status<br> | Case Deferred |
| Party Name<br> | AVIK PHARMACEUTICAL LIMITED |
| Meeting Number<br>and Date<br> | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number<br> | HQRNORM REVIW00008636AM24 |
| RA File Number<br> | 039404000496 AM20 |
| Licence No and<br>Date<br> | 0310831890/27/09/2019 |
| Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite their comments. |
umber<br>|039404000496 AM20| |Licence No and<br>Date<br>|0310831890/27/09/2019| |Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite their comments.||
| Case No. | 30 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Approved |
| Party Name | GLENMARK LIFE SCIENCES LIMITED |
| Meeting Number and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00007586AM24 |
| RA File Number | 039404000509 AM20 |
| Licence No and Date | 0310831946/01/10/2019 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- |
19 This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-07-2024 10:03:09.
UDIN00305042AM25
| Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>6-ETHYL-5-FLUORO-4-<br>HYDROXYPYRIMIDINE<br>3.30 kg.<br>2<br>METHYLENE CHLORIDE<br>6.87 Litre<br>3<br>TETRA HYDRO FURAN<br>20.50 kg.<br>VORICONAZOLE<br>1 kg.<br>4<br>METHANOL<br>1.50 Litre<br>RA concerned may take further necessary action as per above decision of NC. | Export Product | Qty. | Sl. No. | Import Items | Qty. allowed. |
|---|---|---|---|---|---|
| VORICONAZOLE | 1 kg. | 1 | 6-ETHYL-5-FLUORO-4-<br>HYDROXYPYRIMIDINE | 3.30 kg. | |
| 2 | METHYLENE CHLORIDE | 6.87 Litre | |||
| 3 | TETRA HYDRO FURAN | 20.50 kg. | |||
| 4 | METHANOL | 1.50 Litre |
-|---|---|---|---|---| ||VORICONAZOLE|1 kg.|1|6-ETHYL-5-FLUORO-4-<br>HYDROXYPYRIMIDINE|3.30 kg.| ||||2|METHYLENE CHLORIDE|6.87 Litre| ||||3|TETRA HYDRO FURAN|20.50 kg.| ||||4|METHANOL|1.50 Litre|
| Case No. | 31 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Withdrawn |
| Party Name | RELIANCE INDUSTRIES LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | 018205000730AM20 |
| RA File Number | 039504000661 AM20 |
| Licence No and<br>Date | 0310832194/14/10/2019 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to transfer the case toNorms<br>Committee-7as norms for same export product/import items have been finalized by NC-7 in the past. |
| Case No. | 32 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Withdrawn |
| Party Name | RELIANCE INDUSTRIES LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | 018205000729AM20 |
| RA File Number | 039504000662 AM20 |
20
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Licence No and 0310832193/14/10/2019 Date Norms Committee Decision: The Committee considered the case as per agenda and it was decided to transfer the case to Norms Committee-7 as norms for same export product/import items have been finalized by NC-7 in the past.
e Committee considered the case as per agenda and it was decided to transfer the case to Norms Committee-7 as norms for same export product/import items have been finalized by NC-7 in the past.
| Case No. | 33 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Approved |
| Party Name | JODAS EXPOIM PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00006429AM24 |
| RA File Number | 092404000365 AM20 |
| Licence No and<br>Date | 0910068207/20/11/2019 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as applied by the firm as under:<br>Export Product<br>Qty.<br>Sl. No.Import Items<br>Qty. allowed.<br>Ertapenem for Injection 1 gram/ vial<br>66667<br>Number<br>1<br>ERTAPENEM SODIUM (<br>Imports and exports are<br>governed by PC 9 dated<br>30.06.2003 as amended)<br>70.000 kg.<br>RA concerned may take further necessary action as per above decision of NC. |
| Case No. | 34 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Approved |
| Party Name | AQUILA ORGANICS PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
21
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ET/Jun/202425/5| |---|---| |Case Status|Case Approved| |Party Name|AQUILA ORGANICS PRIVATE LIMITED| |Meeting Number<br>and Date|NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024|
21
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| HQ File Number<br>HQRNORM REVIW00001077AM25 | ||
|---|---|---|
| RA File Number<br>039404000879 AM20 | ||
| Licence No and<br>Date<br>0310834406/22/01/2020 | ||
| Norms Committee Decision: | ||
| The Committee considered the case as per agenda and taking cue from the earlier decision for same | ||
| export product/import product in meetingNo.NC/3/MEET/Jan/202324/20 dated 18/01/2024against | ||
| advance authorizationNo.0318830783 dated N/A, it was decided to fix ad-hoc 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.<br>Sl. No. Import Items | Qty. allowed. | |
| 1<br>2,3 Dimethyl 1 Butene<br>7-Acetyl-1,1,3,4,4,6-Hexamethyl<br>1 kg. | 0.93 kg. | |
| 1,2,3,4-Tetrahydro Naphthalene | ||
| 2<br>PARACYMENE | 0.74 kg. | |
| RA concerned may take further necessary action as per above decision of NC. |
r>7-Acetyl-1,1,3,4,4,6-Hexamethyl<br>1 kg.|0.93 kg.|| |1,2,3,4-Tetrahydro Naphthalene||| |2<br>PARACYMENE|0.74 kg.|| |RA concerned may take further necessary action as per above decision of NC.|||
| Case No. | 35 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Rejected |
| Party Name | SYNTHO CHIRALS PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00000542AM25 |
| RA File Number | 092404000540 AM20 |
| Licence No and<br>Date | 0910068421/28/01/2020 |
| Norms Committee Decision: | |
| The Committee | considered the request of firm for review of ad-hoc norms and it was observed that the |
| firm has not provided any technical justification / information for enhancement. Hence, it was decided to | |
| rejectthe case maintaining thestatus quo. |
Case No. 36 / NC/3/MEET/Jun/202425/5
22
UDIN00305042AM25
| Case Status | Case Deferred |
|---|---|
| Party Name | STRIDES ALATHUR PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | 018305000750AM20 |
| RA File Number | 092404000575 AM20 |
| Licence No and<br>Date | 0910068524/28/02/2020 |
| Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it<br>was decided to call for following information/documents from the firm:-<br>Drug Manufacturing Licence (DML)<br>1.<br>Masgter Batch Formula showing net-content of imports in the export<br>2. |
decided to call for following information/documents from the firm:-<br>Drug Manufacturing Licence (DML)<br>1.<br>Masgter Batch Formula showing net-content of imports in the export<br>2.||
| Case No. | 37 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Withdrawn |
| Party Name | RELIANCE INDUSTRIES LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | 018205001170AM20 |
| RA File Number | 039504001136 AM20 |
| Licence No and<br>Date | 0310835545/20/03/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to transfer the case toNorms<br>Committee-7as norms for same export product/import items have been finalized by NC-7 in the past. |
| Case No. | 38 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Withdrawn |
| Party Name | RELIANCE INDUSTRIES LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | 018205001184AM21 |
| RA File Number | 039504001243 AM20 |
| Licence No and<br>Date | 0310835621/18/04/2020 |
23 This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-07-2024 10:03:09.
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Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to transfer the case to Norms Committee-7 as norms for same export product/import items have been finalized by NC-7 in the past.
| Case No. | 39 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00005893AM24 |
| RA File Number | 039504000017 AM21 |
| Licence No and<br>Date | 0310835789/21/04/2020 |
| Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of<br>the TE, it was decided to call for following information/documents from the firm:-<br>Drug Manufacturing License (DML) with approved composition.<br>1.<br>Master-Batch Formula.<br>2. |
| Case No. | 40 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Withdrawn |
| Party Name | RELIANCE INDUSTRIES LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | 018205001220AM21 |
| RA File Number | 039504001109 AM20 |
| Licence No and<br>Date | 0310835972/26/04/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to transfer the case toNorms<br>Committee-7as norms for same export product/import items have been finalized by NC-7 in the past. |
24 This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-07-2024 10:03:09.
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for same export product/import items have been finalized by NC-7 in the past.||
24 This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-07-2024 10:03:09.
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| Case No. | 41 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | ARENE LIFE SCIENCES PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00006628AM24 |
| RA File Number | 092404000024 AM21 |
| Licence No and<br>Date | 0910068681/28/04/2020 |
| Norms Committee Decision:<br> The Committee considered the case as per agenda and it was observed that the firm was called for Personal<br>Hearing on 16/05/2024, but the firm could not appear before Norms Committee. After that it was decided<br>to grant one more opportunity to the firm for aPersonal Hearingwith relevant documents/information. |
| Case No. | 42 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Withdrawn |
| Party Name | RELIANCE INDUSTRIES LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | 018205001254AM21 |
| RA File Number | 039504000020 AM21 |
| Licence No and<br>Date | 0310836081/04/05/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to transfer the case toNorms<br>Committee-7as norms for same export product/import items have been finalized by NC-7 in the past. |
tee considered the case as per agenda and it was decided to transfer the case toNorms<br>Committee-7as norms for same export product/import items have been finalized by NC-7 in the past.||
| Case No. | 43 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Approved |
| Party Name | AMI ORGANICS LIMITED |
| Meeting Number and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00008587AM24 |
| RA File Number | 522404000007 AM21 |
| Licence No and Date | 5210043401/22/05/2020 |
| Norms Committee Decision: |
25 This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-07-2024 10:03:09.
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The Committee considered the case as per agenda and it was decided to fix ad-hoc 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. No. | Import Items | Qty. allowed. |
|---|---|---|---|---|
| 5-NITROSO-2,4,6-<br>TRIAMINOPYRIMIDINE<br> | 1 kg. | 1 | MALONONITRILE | 0.571 kg. |
| 2 | GUANIDINE HCL | 0.826 kg. | ||
| 3 | N,N DIMETHYL FORMAMIDE<br>99. 5% (Tech. Spec. Liquid) | <br>3.465 kg. |
Note: The ad-hoc norms fixed for one time basis.
| Case No. | 44 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Withdrawn |
| Party Name | RELIANCE INDUSTRIES LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | 018205001364AM21 |
| RA File Number | 039504000105 AM21 |
| Licence No and<br>Date | 0310836584/09/06/2020 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to transfer the case toNorms<br>Committee-7as norms for same export product/import items have been finalized by NC-7 in the past. |
| Case No. | 45 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
26
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| Party Name | VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED |
|---|---|
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00005894AM24 |
| RA File Number | 039504000137 AM21 |
| Licence No and<br>Date | 0310836741/18/06/2020 |
| Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of<br>the TE, it was decided to call for following information/documents from the firm:-<br>Drug Manufacturing License (DML) with approved composition. |
of ad-hoc norms and as per the advise of<br>the TE, it was decided to call for following information/documents from the firm:-<br>Drug Manufacturing License (DML) with approved composition.||
| Case No. | 46 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Rejected |
| Party Name | SYNTHO CHIRALS PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00000546AM25 |
| RA File Number | 092404000185 AM21 |
| Licence No and<br>Date | 0910068991/22/07/2020 |
| Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, it was decided toreject<br>the case maintaining thestatus quo. |
| Case No. | 47 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Approved |
| Party Name | HALDIA PETROCHEMICALS LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | 018205001724AM21 |
| RA File Number | 022404000087 AM21 |
| Licence No and<br>Date | 0210210144/06/10/2020 |
| Norms Committee Decision: |
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The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
AM25
The Committee considered the case as per agenda and it was decided to fix ad-hoc 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.<br> | Sl. No. | Import Items | Qty. allowed. |
|---|---|---|---|---|
| Benzene<br>(from olefinic complex) | 1 MT | 1<br> | Light Naphtha | 1.194 MT |
| Case No. | 48 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | AURORE LIFE SCIENCES PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00004138AM23 |
| RA File Number | 092404000365 AM21 |
| Licence No and<br>Date | 0910069368/22/10/2020 |
| Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite their comments. |
| Case No. | 49 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Approved |
| Party Name | ALEOR DERMACEUTICALS LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | 018205001853AM21 |
| RA File Number | 342404000223 AM21 |
| Licence No and<br>Date | 3410046549/13/11/2020 |
| Norms Committee Decision: |
28
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The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
AM25
The Committee considered the case as per agenda and it was decided to fix ad-hoc 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. allowed. |
|---|---|---|---|---|
| Nystatin and Triamcinolone Acetonide<br>Ointment USP, 1,00,000 UNITS / GM;<br>0.1% (15 gm Tube). | <br> <br>1 Number | 1 | Nystatin USP | 238.65 mg |
| Nystatin and Triamcinolone Acetonide<br>Ointment USP, 1,00,000 UNITS / GM;<br>0.1% (30 gm Tube). | <br> <br>1 Number | 2 | Nystatin USP | 477.30 mg. |
| Nystatin and Triamcinolone Acetonide<br>Ointment USP, 1,00,000 UNITS / GM;<br>0.1% (60 gm Tube) | 1 Number | 3 | Nystatin USP | 954.61 mg. |
| Nystatin and Triamcinolone Acetonide<br>Cream USP, 1,00,000 UNITS / GM;<br>0.1% (15 gm Tube) | <br> <br>1 Number | 4 | Nystatin USP | 238.65 mg. |
| Nystatin and Triamcinolone Acetonide<br>Cream USP, 1,00,000 UNITS / GM;<br>0.1% (30 gm Tube). | <br> <br>1 Number | 5 | Nystatin USP | 477.30 mg. |
| Nystatin and Triamcinolone Acetonide<br>Cream USP, 1,00,000 UNITS / GM;<br>0.1% (60 gm Tube) | <br> <br>1 Number | 6 | Nystatin USP | 954.61 mg |
| Case No. | 50 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | MAC-CHEM PRODUCTS (INDIA) PRIVATE LIMITED |
| Meeting Number | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
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MEET/Jun/202425/5| |---|---| |Case Status|Case Deferred| |Party Name|MAC-CHEM PRODUCTS (INDIA) PRIVATE LIMITED| |Meeting Number|NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024|
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| and Date | |
|---|---|
| HQ File Number | HQRNORM REVIW00005491AM24 |
| RA File Number | NA |
| Licence No and<br>Date | 0311000185/17/12/2020 |
| Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite their comments. |
| Case No. | 51 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | CIPLA LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00000254AM24 |
| RA File Number | 03AA04011698 AM21 |
| Licence No and<br>Date | 0311000235/21/12/2020 |
| Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite their comments. |
| Case No. | 52 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Rejected |
| Party Name | SYNTHO CHIRALS PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00000543AM25 |
| RA File Number | 09AA04003656 AM21 |
| Licence No and<br>Date | 0911000173/11/01/2021 |
| Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, it was decided toreject<br>the case maintaining thestatus quo. |
30 This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-07-2024 10:03:09.
for enhancement. Hence, it was decided toreject<br>the case maintaining thestatus quo.||
30 This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-07-2024 10:03:09.
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| Case No. | 53 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | ANANTA MEDICARE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00008364AM24 |
| RA File Number | 05AA04025954 AM21 |
| Licence No and<br>Date | 0511001043/02/02/2021 |
| Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Drug Manufacturing Licence (DML).<br>1.<br>Master-Batch Formula<br>2.<br>Certificate of Analysis (CoA) of import item.<br>3. |
| Case No. | Case No. | 54 / NC/3/MEET/Jun/202425/5 | 54 / NC/3/MEET/Jun/202425/5 | 54 / NC/3/MEET/Jun/202425/5 | 54 / NC/3/MEET/Jun/202425/5 | 54 / NC/3/MEET/Jun/202425/5 |
|---|---|---|---|---|---|---|
| Case Status | Case Approved | |||||
| Party Name | ORIENTAL AROMATICS LIMITED | |||||
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 | |||||
| HQ File Number | HQRNORM REVIW00008140AM24 | |||||
| RA File Number | 03AA04029725 AM21 | |||||
| Licence No and<br>Date | 0311002554/16/03/2021 | |||||
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. |
|Licence No and<br>Date||0311002554/16/03/2021||||| |Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>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. No. Import Items<br>Qty. allowed.<br>1<br>Alpha Pinene<br>1.813 kg.<br>MYSORNAOL AB18019<br>1 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||MYSORNAOL AB18019||1 kg.|1<br>|Alpha Pinene|1.813 kg.|
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| 2<br>Sec butanol<br>0.425 kg.<br>3<br>Aluminium Tri Sec Butoxide<br>0.08 kg.<br>(Perfumery Compound)<br>4<br>Di -N- Butylamine<br>0.03 kg.<br>RA concerned may take further necessary action as per above decision of NC. | (Perfumery Compound) | 2<br> | Sec butanol | 0.425 kg. | |
|---|---|---|---|---|---|
| 3<br> | Aluminium Tri Sec Butoxide | 0.08 kg. | |||
| 4<br> | Di -N- Butylamine | 0.03 kg. |
| tion as per above decision of NC. | (Perfumery Compound) | 2<br> | Sec butanol | 0.425 kg. | |
|---|---|---|---|---|---|
| 3<br> | Aluminium Tri Sec Butoxide | 0.08 kg. | |||
| 4<br> | Di -N- Butylamine | 0.03 kg. |
| Case No. | 55 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Approved |
| Party Name | NEOGEN CHEMICALS LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00004030AM23 |
| RA File Number | 03AA04033623 AM21 |
| Licence No and<br>Date | 0311003093/08/04/2021 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>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. No. Import Items<br>Qty. allowed.<br>1<br>ISO BUTANOL<br>1.08 kg.<br>ISO BUTYL BROMIDE<br>(1-BROMO<br>-2-<br>METHYL<br>PROPARNE)<br>1 kg.<br>2<br>LIQUID BROMINE<br>1.16 kg<br>RA concerned may take further necessary action as per above decision of NC. |
32
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OMIDE<br>(1-BROMO<br>-2-<br>METHYL<br>PROPARNE)<br>1 kg.<br>2<br>LIQUID BROMINE<br>1.16 kg<br>RA concerned may take further necessary action as per above decision of NC.||
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| Case No. | 56 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | SUDEEP PHARMA PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM APPLY 00122419AM22 |
| RA File Number | 34AA04003768 AM22 |
| Licence No and<br>Date | 3411000762/23/06/2021 |
| Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of<br>the TE, it was decided to call for following information/documents from the firm:-<br>Complete Chemistry.<br>1.<br>Material balance & Yield.<br>2. |
| Case No.<br> | Case No.<br> | 57 / NC/3/MEET/Jun/202425/5 | 57 / NC/3/MEET/Jun/202425/5 | 57 / NC/3/MEET/Jun/202425/5 | 57 / NC/3/MEET/Jun/202425/5 | 57 / NC/3/MEET/Jun/202425/5 |
|---|---|---|---|---|---|---|
| Case Status<br> | Case Approved | |||||
| Party Name<br> | HIKAL LIMITED | |||||
| Meeting Number<br>and Date<br> | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 | |||||
| HQ File Number<br> | HQRNORM REVIW00004361AM24 | |||||
| RA File Number<br> | 34AA04002140 AM22 | |||||
| Licence No and<br>Date<br> | 3411000771/28/06/2021 | |||||
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>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. No. |
agenda and it was decided to fix ad-hoc norms under Para<br>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. No. Import Items<br>Qty. allowed.<br>1<br>Insoluble saccharin (Saccharin imide)<br>1.013 kg.<br>Probenazole<br>1 kg.<br>2<br>Allyl alcohol<br>0.30 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Probenazole||1 kg.|1|Insoluble saccharin (Saccharin imide)|1.013 kg.| |||||2|Allyl alcohol|0.30 kg.| ||||||||
33
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| Case No. | 58 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Rejected |
| Party Name | SYNTHO CHIRALS PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00000544AM25 |
| RA File Number | 09AA04007265 AM22 |
| Licence No and<br>Date | 0911001194/12/07/2021 |
| Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, it was decided toreject<br>the case maintaining thestatus quo. |
ms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, it was decided toreject<br>the case maintaining thestatus quo.||
| Case No. | 59 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | SUDEEP PHARMA PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM APPLY 00137048AM22 |
| RA File Number | 34AA04005105 AM22 |
| Licence No and<br>Date | 3411000838/12/07/2021 |
| Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it has been observed that<br>the firm has furnished incomplete documents/information as sought by the Committee in the NC-3<br>meeting held on 28/07/2023. Therefore, it has been decided that the firm may be asked to furnish the<br>following documents/information:-<br>1. Complete chemistry, Molecular weight and percentage yield on molar basis.<br>2. Certificate of Analysis (CoA) of export product. |
34 This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-07-2024 10:03:09.
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on molar basis.**<br>2. Certificate of Analysis (CoA) of export product.||
34 This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-07-2024 10:03:09.
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| Case No. | Case No. | 60 / NC/3/MEET/Jun/202425/5 | 60 / NC/3/MEET/Jun/202425/5 | 60 / NC/3/MEET/Jun/202425/5 | 60 / NC/3/MEET/Jun/202425/5 | 60 / NC/3/MEET/Jun/202425/5 | 60 / NC/3/MEET/Jun/202425/5 | 60 / NC/3/MEET/Jun/202425/5 | 60 / NC/3/MEET/Jun/202425/5 | 60 / NC/3/MEET/Jun/202425/5 | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Case Status | Case Approved | ||||||||||
| Party Name | AETHER INDUSTRIES LIMITED | ||||||||||
| Meeting Number an<br>Date | d | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 | |||||||||
| HQ File Number | HQRNORM REVIW00008736AM24 | ||||||||||
| RA File Number | 52AA04008175 AM22 | ||||||||||
| Licence No and Da | te | 5211001047/26/07/2021 | |||||||||
| Norms Committee | Decision: | ||||||||||
| The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>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. No.<br>Import Items<br>Qty. allowed.<br>1<br>2 6 DICHLOROTOLUENE<br>1.90 kg.<br>2<br>TETRAHYDROFURAN<br>2.00 kg.<br>3<br>MAGNESIUM TURNINGS<br>0.60 kg.<br>BIFENTHRIN ALCOHOL<br>1 kg. | |||||||||||
| Export Product | Qty. | Sl. N | o. | Impor | t Items | Qty. allowed. | |||||
| BIFENTHRIN ALCOHOL | 1 kg. | 1 | 2 6 DI | CHLOROT | OLUENE | 1.90 kg. | |||||
| 2 | TETR | AHYDROF | URAN | 200 kg | |||||||
| . |
|||Qty.|Sl. N|o.|Impor|t Items|||Qty. allowed.| ||||||||||||| ||BIFENTHRIN ALCOHOL|||1 kg.|1||2 6 DI|CHLOROT|OLUENE||1.90 kg.| ||||||2||TETR|AHYDROF|URAN||200 kg| |||||||||||. .|| ||||||3||MAGNESIUM TURNINGS|||0.60 kg.|| ||||||||||||| ||||||4||n HEPTANE|||1.77 kg.|| ||||||||||||| |RA concerned m||ay take further necessary action as per above decision of NC.|||||||||| ||||||||||||| ||||||||||||| ||||||||||||| ||||||||||||| |Case No.||61 / NC/3/MEET/Jun/202425/5|||||||||| |Case Status||Case Approved|||||||||| |Party Name||SUNDYOTA NUMANDIS PROBIOCEUTICALS PRIVATE LIMITED|||||||||| ||||||||||||| |Meeting Number<br>and Date||NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024|||||||||| |HQ File Number||HQRNORM REVIW00004161AM24|||||||||| |RA File Number||08AA04021121 AM22|||||||||| |Licence No and||0811002324/16/08/2021||||||||||
| Case No. | 61 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Approved |
| Party Name | SUNDYOTA NUMANDIS PROBIOCEUTICALS PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00004161AM24 |
| RA File Number | 08AA04021121 AM22 |
| Licence No and | 0811002324/16/08/2021 |
35
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Date
Norms Committee Decision:
The Committee considered the case as per agenda and it has been observed that ad-hoc norms had already been fixed in respect of Advance Authorisation No. 0811002324 dated 16/08/2021 by the Committee in its meeting held on 06/06/2024. Therefore, it was decided to close the application of the firm.
| Date | Date | ||||||
|---|---|---|---|---|---|---|---|
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it has been observed that ad-hoc norms had already<br> | |||||||
| been fixed in resp<br>i hld | ect of Advance Authorisation No. 0811002324 dated 16/08/2021 by the Committee in its<br>6/06/2024 Thf i diddlh lii f h fi | ||||||
| meetng e on | . ereore, t was ece tocosete appcaton o te rm. | ||||||
| Case No | 62 / NC/3/MEET/Jun/202425/5 | ||||||
| . | |||||||
| Case Status | Case Approved | ||||||
| A | |||||||
| Party Name | FRESENIUS KBI ONCOLOGY LIMITED | ||||||
| Meeting Number and<br>Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 | ||||||
| HQ File Number | HQRNORM APPLY 00165403AM22 | ||||||
| RA File Number | 05AA04062260 AM22 | ||||||
| Licence No and Date | 0511004178/18/08/2021 | ||||||
| Norms Committee Decision:<br> | |||||||
| The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- | |||||||
| Exort | Product | Qt | Sl No | Imort Items | Qt allowed | ||
| p | y. | . . | p | **y. |
Vol. I as per details given below or as applied by the firm, whichever is less:-|||||||| ||Exort|Product||Qt|Sl No|Imort Items|Qt allowed| ||p|||y.|. .|p|y. .| ||||||||| ||Ropivacaine<br>Monohydrate|Hydrochloride<br>(API)||<br>1 kg.|1|(S)-2',6' Pipecoloxylidide|0.872 kg.| ||||||||| ||||||||| ||Roivacaine|Hdrochloride||<br>1 k|2|(S)-2'6'Piecoloxlidide|0923 k| ||p<br>Anhydrous(A|y<br>PI)||<br>g.||,py|. g.| |RA concerned may take further necessary action as per above decision of NC.|||||||| |||||||||
| Case No. | 63 / NC/3/MEET/Jun/202425/5 |
| Case Status | Case Approved |
| Party Name | SRF LIMITED |
| Meeting Number | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| and Date |
36
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| HQ File Number | HQRNORM REVIW00007920AM24 |
|---|---|
| RA File Number | 05AA04070230 AM22 |
| Licence No and<br>Date | 0511004557/06/09/2021 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Apr/202425/2 dated 30/04/2024against advance<br>authorizationNo.0511015715 dated 09/11/2022, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl. No. |
11/2022**, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP 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>allowed.<br>1<br>HYDRAZINE HYDRATE (80 %)<br>0.56 kg.<br>2<br>Potassium Carbonate Powder<br>0.94 kg.<br>3<br>2,2'-Dichlorodiethyl ether (DCEE)<br>1.50 kg.<br>4<br>DIMETHYL SULFOXIDE (DMSO) 1.30 kg.<br>5<br>CAUSTIC POTASH LYE<br>(POTASSIUM HYDROXIDE 95 %<br>0.72 kg<br>6<br>PENTANOL<br>(ISOMER MIXTURE)<br>0.10 kg.<br>1-(5-ACETYL-[1,4,5]<br>OXADIAZEPAN-4-YL)-<br>ETHANONE<br>1 kg.<br>7<br>ACETIC ANHYDRIDE<br>1.90 kg.<br>RA concerned may take further necessary action as per above decision of NC.||
| Case No. | 64 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Approved |
| Party Name | SRF LIMITED |
37
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| Meeting Number and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
|---|---|
| HQ File Number | HQRNORM REVIW00008056AM24 |
| RA File Number | 05AA04076999 AM22 |
| Licence No and Date | 0511004742/15/09/2021 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Apr/202425/2 dated 30/04/2024against advance<br>authorizationNo.0511015715 dated 09/11/2022, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP 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. |
to fix ad-hoc norms under Para 4.07 of<br>HBP 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. allowed.<br>1<br>METHOXY-AA TECH. 12 [GB]<br>0.820 kg.<br>2<br>TOLUENE<br>0.270 kg.<br>3<br>TRI ETHYL AMINE (TEA)<br>0.140 kg.<br>4<br>Potassium Carbonate Powder<br>0.020 kg.<br>5<br>ETHYL VINYL ETHER<br>0.330 kg.<br>6<br>ACETIC ACID<br>0.030 kg.<br>3-PYRIDINECARBOXYLIC<br>ACID, 2-<br>[(2METHOXYETHOXY)<br>METHYL]-6-<br>(TRIFLUOROMETHYL)-<br>ETHYL ESTER<br>1 kg.<br>7<br>ORTHOXYLENE<br>0.140 kg.<br>RA concerned may take further necessary action as per above decision of NC.||
| Case No. | 65 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | KOPRAN RESEARCH LABORATORIES LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM APPLY 00192148AM22 |
| RA File Number | 03AA04091496 AM22 |
38
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ABORATORIES LIMITED| |Meeting Number<br>and Date|NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024| |HQ File Number|HQRNORM APPLY 00192148AM22| |RA File Number|03AA04091496 AM22|
38
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| Licence No and<br>Date | 0311007180/23/09/2021 |
|---|---|
| Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was observed<br>that during the Personal Hearing held on 16/05/2024, the firm was advised to furnish the following<br>information/documents, however, the same still not received from the firm. Therefore, it was decided that<br>the firm may be again advised to furnish the following documents as sought earlier:<br>Complete batch chemical reaction showing description of export and import item along with<br>percentage yield on molar basis.<br>I.<br>Certificate of Analysis (CoA) of import item to explain the complete description of import item<br>No.1<br>II. |
| Case No. | 66 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | AMOLI ORGANICS PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM APPLY 00193597AM22 |
| RA File Number | 03AA04097753 AM22 |
| Licence No and<br>Date | 0311007198/25/09/2021 |
| |Meeting Number<br>and Date|NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024| |HQ File Number|HQRNORM APPLY 00193597AM22| |RA File Number|03AA04097753 AM22| |Licence No and<br>Date|0311007198/25/09/2021| |Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Personal Hearing<br>before Norms Committee to explain its case along with following information /<br>documents from the firm:-<br>Certificate of Analysis (CoA) of import item from Foreign Supplier showing particle size of<br>import.<br>1.<br>Copy of Bill of Entry in support of 1 above.<br>2.||
| Case No. | 67 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Approved |
| Party Name | FDC LIMITED |
| Meeting Number | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
39
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| and Date | |
|---|---|
| HQ File Number | HQRNORM REVIW00006071AM24 |
| RA File Number | 03AA040106642 AM22 |
| Licence No and<br>Date | 0311007268/28/09/2021 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>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. No.<br>Import Items<br>Qty. allowed.<br>BRIMONIDINE<br>EYE<br>DROPS 0.2% w/v, 5 ML<br>Vial.<br>1 Number<br>1<br>BRIMONIDINE L TARTRATE<br>10.2 mg.<br>RA concerned may take further necessary action as per above decision of NC. |
ed.**<br>BRIMONIDINE<br>EYE<br>DROPS 0.2% w/v, 5 ML<br>Vial.<br>1 Number<br>1<br>BRIMONIDINE L TARTRATE<br>10.2 mg.<br>RA concerned may take further necessary action as per above decision of NC.||
| Case No. | 68 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | KRITI NUTRIENTS LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00001036AM25 |
| RA File Number | 56AA04005794 AM22 |
| Licence No and<br>Date | 5611000556/12/10/2021 |
| Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of<br>the TE, it was decided to call for following information/documents from the firm:-<br>Complete Certificate of Analysis (CoA) of import items from Foreign Supplier. |
40
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| Case No. | Case No. | 69 / NC/3/MEET/Jun/202425/5 | 69 / NC/3/MEET/Jun/202425/5 | 69 / NC/3/MEET/Jun/202425/5 | 69 / NC/3/MEET/Jun/202425/5 | 69 / NC/3/MEET/Jun/202425/5 |
|---|---|---|---|---|---|---|
| Case Status | Case Approved | |||||
| Party Name | LUPIN LIMITED | |||||
| Meeting Number and<br>Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 | |||||
| HQ File Number | HQRNORM REVIW00005265AM24 | |||||
| RA File Number | 03AA040109357 AM22 | |||||
| Licence No and Date | 0311007760/18/10/2021 | |||||
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>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. No. |
agenda and it was decided to fix ad-hoc norms under Para<br>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. No. Import Items<br>Qty. allowed.<br>1<br>T-BUTYL,<br>3S-AMINO-<br>2,3,4,5-TETRAHYDRO-1-<br>H-(1) BENAZEPIN-2-ONE-<br>1-ACETATE<br>32.97 mg.<br>Amlodipine<br>Besylate<br>and<br>Benazepril Hydrochloride Cap<br>USP5/ 40mg<br>1 Number<br>2<br>(R)-2-HYDROXY-4-<br>PHENYLBUTANOIC ACID<br>ETHYL ESTER<br>22.726 mg.<br>3<br>T-BUTYL,<br>3S-AMINO-<br>2,3,4,5-TETRAHYDRO-1-<br>H-(1) BENAZEPIN-2-ONE-<br>1-ACETATE<br>32.97 mg.<br>Amlodipine<br>Besylate<br>and<br>Benazepril Hydrochloride Cap<br>USP10/ 40mg<br>1 Number<br>4<br>R)-2-HYDROXY-4-<br>PHENYLBUTANOIC ACID<br>ETHYL ESTER<br>22.726 mg.<br>5<br>T-BUTYL,<br>3S-AMINO-<br>2,3,4,5-TETRAHYDRO-1-<br>H-(1) BENAZEPIN-2-ONE-<br>1-ACETATE<br>8.24 mg.<br>Amlodipine<br>and<br>Benazepril<br>Hydrochloride Cap USP5/ 10mg<br>1 Number<br>6<br>(R)-2-HYDROXY-4-<br>PHENYLBUTANOIC ACID<br>ETHYL ESTER<br>5.681 mg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|**Qty.
pril<br>Hydrochloride Cap USP5/ 10mg<br>1 Number<br>6<br>(R)-2-HYDROXY-4-<br>PHENYLBUTANOIC ACID<br>ETHYL ESTER<br>5.681 mg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Amlodipine<br>Besylate<br>and<br>Benazepril Hydrochloride Cap<br>USP5/ 40mg||<br> <br>1 Number|1|T-BUTYL,<br>3S-AMINO-<br>2,3,4,5-TETRAHYDRO-1-<br>H-(1) BENAZEPIN-2-ONE-<br>1-ACETATE|32.97 mg.| |||||2|(R)-2-HYDROXY-4-<br>PHENYLBUTANOIC ACID<br>ETHYL ESTER|<br>22.726 mg.| ||Amlodipine<br>Besylate<br>and<br>Benazepril Hydrochloride Cap<br>USP10/ 40mg||<br> <br>1 Number|3|T-BUTYL,<br>3S-AMINO-<br>2,3,4,5-TETRAHYDRO-1-<br>H-(1) BENAZEPIN-2-ONE-<br>1-ACETATE|32.97 mg.| |||||4|R)-2-HYDROXY-4-<br>PHENYLBUTANOIC ACID<br>ETHYL ESTER|<br>22.726 mg.| ||Amlodipine<br>and<br>Benazepril<br>Hydrochloride Cap USP5/ 10mg||<br>1 Number|5|T-BUTYL,<br>3S-AMINO-<br>2,3,4,5-TETRAHYDRO-1-<br>H-(1) BENAZEPIN-2-ONE-<br>1-ACETATE|8.24 mg.| |||||6|(R)-2-HYDROXY-4-<br>PHENYLBUTANOIC ACID<br>ETHYL ESTER|<br>5.681 mg.|
41
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-BUTYL,<br>3S-AMINO-<br>2,3,4,5-TETRAHYDRO-1-<br>H-(1) BENAZEPIN-2-ONE-<br>1-ACETATE|8.24 mg.| |||||6|(R)-2-HYDROXY-4-<br>PHENYLBUTANOIC ACID<br>ETHYL ESTER|<br>5.681 mg.|
41
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| 7<br>T-BUTYL,<br>3S-AMINO-<br>2,3,4,5-TETRAHYDRO-1-<br>H-(1) BENAZEPIN-2-ONE-<br>1-ACETATE<br>16.483 mg.<br>Amlodipine<br>and<br>Benazepril<br>Hydrochloride Cap USP 5/20<br>mg<br>1 Number<br>8<br>((R)-2-HYDROXY-4-<br>PHENYLBUTANOIC ACID<br>ETHYL<br>ESTER<br>R)-2-<br>HYDROXY-4-<br>PHENYLBUTANOIC ACID<br>ETHYL ESTER<br>11.363 mg.<br>9<br>T-BUTYL,<br>3S-AMINO-<br>2,3,4,5-TETRAHYDRO-1-<br>H-(1) BENAZEPIN-2-ONE-<br>1-ACETATE<br>16.483 mg.<br>Amlodipine<br>Besylate<br>and<br>Benazepril Hydrochloride CAP<br>USP10/ 20mg<br>1 Number<br>10<br>(R)-2-HYDROXY-4-<br>PHENYLBUTANOIC ACID<br>ETHYL ESTER<br>11.363 mg.<br>11<br>T-BUTYL,<br>3S-AMINO-<br>2,3,4,5-TETRAHYDRO-1-<br>H-(1) BENAZEPIN-2-ONE-<br>1-ACETATE<br>8.24 mg.<br>Amlodipine<br>Besylate<br>and<br>Benazepril Hydrochloride Cap<br>2.5/ 10mg<br>1 Number<br>12<br>(R)-2-HYDROXY-4-<br>PHENYLBUTANOIC ACID<br>ETHYL ESTER<br>5.681 mg.<br>RA concerned may take further necessary action as per above decision of NC. | Amlodipine<br>and<br>Benazepril<br>Hydrochloride Cap USP 5/20<br>mg | <br> <br>1 Number | 7 | T-BUTYL,<br>3S-AMINO-<br>2,3,4,5-TETRAHYDRO-1-<br>H-(1) BENAZEPIN-2-ONE-<br>1-ACETATE | 16.483 mg. |
|---|---|---|---|---|---|
| 8 | ((R)-2-HYDROXY-4-<br>PHENYLBUTANOIC ACID<br>ETHYL<br>ESTER<br>R)-2-<br>HYDROXY-4-<br>PHENYLBUTANOIC ACID<br>ETHYL ESTER | <br> <br>11.363 mg. |
-<br>1-ACETATE|16.483 mg.| |---|---|---|---|---|---| ||||8|((R)-2-HYDROXY-4-<br>PHENYLBUTANOIC ACID<br>ETHYL<br>ESTER<br>R)-2-<br>HYDROXY-4-<br>PHENYLBUTANOIC ACID<br>ETHYL ESTER|<br> <br>11.363 mg.| ||Amlodipine<br>Besylate<br>and<br>Benazepril Hydrochloride CAP<br>USP10/ 20mg|<br> <br>1 Number|9|T-BUTYL,<br>3S-AMINO-<br>2,3,4,5-TETRAHYDRO-1-<br>H-(1) BENAZEPIN-2-ONE-<br>1-ACETATE|16.483 mg.| ||||10|(R)-2-HYDROXY-4-<br>PHENYLBUTANOIC ACID<br>ETHYL ESTER|<br>11.363 mg.| ||Amlodipine<br>Besylate<br>and<br>Benazepril Hydrochloride Cap<br>2.5/ 10mg|<br> <br>1 Number|11|T-BUTYL,<br>3S-AMINO-<br>2,3,4,5-TETRAHYDRO-1-<br>H-(1) BENAZEPIN-2-ONE-<br>1-ACETATE|8.24 mg.| ||||12|(R)-2-HYDROXY-4-<br>PHENYLBUTANOIC ACID<br>ETHYL ESTER|<br>5.681 mg.|
| Case No. | 70 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | NAARI PHARMA PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM APPLY 00220580AM22 |
42
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| RA File Number | 05AA04091063 AM22 |
|---|---|
| Licence No and<br>Date | 0511005553/21/10/2021 |
| Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Molecular weight at each step not given.<br>1.<br>Percentage yield on molar basis for each step.<br>2. |
r>TE, it was decided to call for following information/documents from the firm:-<br>Molecular weight at each step not given.<br>1.<br>Percentage yield on molar basis for each step.<br>2.||
| Case No. | 71 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | NAARI PHARMA PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM APPLY 00220582AM22 |
| RA File Number | 05AA04091028 AM22 |
| Licence No and<br>Date | 0511005555/21/10/2021 |
| Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Molecular weight at each step not given.<br>i.<br>Percentage yield on molar basis for each step.<br>ii. |
| Case No. | 72 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Rejected |
| Party Name | JODAS EXPOIM PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM APPLY 00239769AM22 |
| RA File Number | 09AA04001389 AM22 |
| Licence No and<br>Date | 0911001808/02/11/2021 |
43 This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-07-2024 10:03:09.
UDIN00305042AM25
Norms Committee Decision:
The firm vide e-mail dated 27/06/2024 has informed that they have surrendered their above license. In view of e-mail of firm, the Committee decided to close the application of the firm.
| Case No. | 73 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Approved |
| Party Name | FDC LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00006176AM24 |
| RA File Number | 03AA040119771 AM22 |
| Licence No and<br>Date | 0311008387/10/11/2021 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>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. No. Import Items<br>Qty. allowed.<br>BRIMONIDINE<br>EYE<br>DROPS 0.2% w/v, 5 ML<br>Vial.<br>1 Number<br>1<br>BRIMONIDINE L TARTRATE<br>10.2 mg.<br>RA concerned may take further necessary action as per above decision of NC. |
| Case No. | 74 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Approved |
| Party Name | LAXMI ORGANIC INDUSTRIES LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00005991AM24 |
| RA File Number | 03AA04014060 AM22 |
| Licence No and | 0311008817/24/11/2021 |
44
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Date Norms Committee Decision:
25/ 5 and 14/06/2024| |HQ File Number|HQRNORM REVIW00005991AM24| |RA File Number|03AA04014060 AM22| |Licence No and|0311008817/24/11/2021|
44
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Date Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No.NC/3/MEET/Apr/202425/1 dated 10/04/2024 against advance authorization No. 0311008775 dated 23/11/2021 , it was decided to fix ad-hoc 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. allowed. |
|---|---|---|---|---|
| DIMETHYL<br>ACETOACETAMIDE<br>(DIMETHYL<br>ACETOACETAMIDE<br>(DMAAA)) | <br> <br>1 kg. | 1 | Acetic Acid | 0.90 kg. |
| 2 | Dimethyl Amine | 0.45 kg. |
| Case No. | Case No. | 75 / NC/3/MEET/Jun/202425/5 | 75 / NC/3/MEET/Jun/202425/5 | 75 / NC/3/MEET/Jun/202425/5 | 75 / NC/3/MEET/Jun/202425/5 | 75 / NC/3/MEET/Jun/202425/5 |
|---|---|---|---|---|---|---|
| Case Status | Case Approved | |||||
| Party Name | LAXMI ORGANIC INDUSTRIES LIMITED | |||||
| Meeting Number and<br>Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 | |||||
| HQ File Number | HQRNORM REVIW00005995AM24 | |||||
| RA File Number | 03AA04014502 AM22 | |||||
| Licence No and Date | 0311009117/02/12/2021 | |||||
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>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. |
per agenda and it was decided to fix ad-hoc norms under Para<br>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. No.<br>Import Items<br>Qty. allowed.<br>1<br>Acetic Acid<br>0.95 kg.<br>N-BUTYLACETOACETATE ESTER<br>1 kg.<br>2<br>N-BUTANOL<br>0.50 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||N-BUTYLACETOACETATE ESTER||1 kg.|1|Acetic Acid|0.95 kg.| |||||2|N-BUTANOL|0.50 kg.|
| Case No. | Case No. | 75 / NC/3/MEET/Jun/202425/5 | 75 / NC/3/MEET/Jun/202425/5 | 75 / NC/3/MEET/Jun/202425/5 | 75 / NC/3/MEET/Jun/202425/5 | 75 / NC/3/MEET/Jun/202425/5 |
|---|---|---|---|---|---|---|
| Case Status | Case Approved | |||||
| Party Name | LAXMI ORGANIC INDUSTRIES LIMITED | |||||
| Meeting Number and<br>Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 | |||||
| HQ File Number | HQRNORM REVIW00005995AM24 | |||||
| RA File Number | 03AA04014502 AM22 | |||||
| Licence No and Date | 0311009117/02/12/2021 | |||||
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>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. No.<br>Import Items<br>Qty. allowed.<br>1<br>Acetic Acid<br>0.95 kg.<br>N-BUTYLACETOACETATE ESTER<br>1 kg.<br>2<br>N-BUTANOL<br>0.50 kg. | ||||||
| Export Product | Qty. | Sl. No. | Import Items | Qty. allowed. | ||
| N-BUTYLACETOACETATE ESTER | 1 kg. | 1 | Acetic Acid | 0.95 kg. | ||
| 2 | N-BUTANOL | 0.50 kg. |
r>N-BUTANOL<br>0.50 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||N-BUTYLACETOACETATE ESTER||1 kg.|1|Acetic Acid|0.95 kg.| |||||2|N-BUTANOL|0.50 kg.|
45
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| Case No. | 76 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | ANANTA MEDICARE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00008200AM24 |
| RA File Number | 05AA040108247 AM22 |
| Licence No and<br>Date | 0511006681/07/12/2021 |
| Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of<br>the TE, it was decided to call for following information/documents from the firm:-<br>Drug Manufacturing Licence (DML) with approved composition.<br>1.<br>Master-Batch Formula for each export.<br>2.<br>Certificate of Analysis (CoA) of import item.<br>3. |
| Case No. | 77 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | SUDEEP PHARMA PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM APPLY 00293146AM22 |
| RA File Number | 34AX04000029 AM22 |
| Licence No and<br>Date | 3411001569/21/12/2021 |
| Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of<br>the TE, it was decided to call for following information/documents from the firm:- |
46 This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-07-2024 10:03:09.
advise of<br>the TE, it was decided to call for following information/documents from the firm:-||
46 This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-07-2024 10:03:09.
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-
Certificate of Analysis (CoA) of both import and export items giving clearly percentage of its purity.
-
Sample of Shipping Bills and Bill of Entry of the export products and statement of export import of the Authorisation.
| Case No. | 78 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | ANANTA MEDICARE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00008265AM24 |
| RA File Number | 05AX04000189 AM22 |
| Licence No and<br>Date | 0511007079/21/12/2021 |
| Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of<br>the TE, it was decided to call for following information/documents from the firm:-<br>Drug Manufacturing Licence (DML) with approved composition.<br>i.<br>Master-Batch Formula for each export.<br>ii.<br>Certificate of Analysis (CoA) of import item.<br>iii. |
e firm:-<br>Drug Manufacturing Licence (DML) with approved composition.<br>i.<br>Master-Batch Formula for each export.<br>ii.<br>Certificate of Analysis (CoA) of import item.<br>iii.||
| Case No. | 79 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Approved |
| Party Name | FDC LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00006188AM24 |
| RA File Number | 03AX04000256 AM22 |
| Licence No and<br>Date | 0311009818/27/12/2021 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- |
47 This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-07-2024 10:03:09.
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| Export Product | Qty. | **Sl. No. ** | Import Items | Qty. allowed. |
|---|---|---|---|---|
| GENTAMICIN EAR/EYE DROPS 10 | <br>1 Number | 1 | GENTAMICIN | 30.6 mg. |
| ML, 0.3% w/v | SULPHATE |
5
| Export Product | Qty. | **Sl. No. ** | Import Items | Qty. allowed. |
|---|---|---|---|---|
| GENTAMICIN EAR/EYE DROPS 10 | <br>1 Number | 1 | GENTAMICIN | 30.6 mg. |
| ML, 0.3% w/v | SULPHATE |
| Case No. | Case No. | 80 / NC/3/MEET/Jun/202425/5 | 80 / NC/3/MEET/Jun/202425/5 | 80 / NC/3/MEET/Jun/202425/5 | 80 / NC/3/MEET/Jun/202425/5 | 80 / NC/3/MEET/Jun/202425/5 |
|---|---|---|---|---|---|---|
| Case Status | Case Approved | |||||
| Party Name | ALEMBIC PHARMACEUTICALS LIMITED | |||||
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 | |||||
| HQ File Number | HQRNORM APPLY 00299896AM22 | |||||
| RA File Number | 34AX04000090 AM22 | |||||
| Licence No and<br>Date | 3411001598/28/12/2021 | |||||
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc 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. allowed.<br>1<br>Clomipramine<br>Hydrochloride USP<br>25.50 mg.<br>2<br>Microcrystalline Cellulose<br>(Avicel PH 301)<br>148.80 mg.<br>3<br>Pregelatinized<br>starch<br>(Starch 1500 LM)<br>39.60 mg.<br>4<br>Colloidal silicon dioxide<br>(Aerosil 200 Pharma)<br>2.20 mg.<br>Magnesium<br>Stearate<br>CLOMIPRAMINE HCL CAP USP 25 MG<br>1 Number<br>5<br>4.40 mg. | ||||||
| Export Product | Qty. | **Sl. No. ** | Import Items | **Qty. |
br>(Aerosil 200 Pharma)<br>2.20 mg.<br>Magnesium<br>Stearate<br>CLOMIPRAMINE HCL CAP USP 25 MG<br>1 Number<br>5<br>4.40 mg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||CLOMIPRAMINE HCL CAP USP 25 MG||1 Number|1<br> <br>|Clomipramine<br>Hydrochloride USP|25.50 mg.| |||||2<br> <br>|Microcrystalline Cellulose<br>(Avicel PH 301)|<br>148.80 mg.| |||||3<br> <br>|Pregelatinized<br>starch<br>(Starch 1500 LM)|<br>39.60 mg.| |||||4<br> <br>|Colloidal silicon dioxide<br>(Aerosil 200 Pharma)|<br>2.20 mg.| |||||<br>5|Magnesium<br>Stearate|<br>4.40 mg.|
| Case No. | Case No. | 80 / NC/3/MEET/Jun/202425/5 | 80 / NC/3/MEET/Jun/202425/5 | 80 / NC/3/MEET/Jun/202425/5 | 80 / NC/3/MEET/Jun/202425/5 | 80 / NC/3/MEET/Jun/202425/5 |
|---|---|---|---|---|---|---|
| Case Status | Case Approved | |||||
| Party Name | ALEMBIC PHARMACEUTICALS LIMITED | |||||
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 | |||||
| HQ File Number | HQRNORM APPLY 00299896AM22 | |||||
| RA File Number | 34AX04000090 AM22 | |||||
| Licence No and<br>Date | 3411001598/28/12/2021 | |||||
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc 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. |
to fix ad-hoc 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. allowed.<br>1<br>Clomipramine<br>Hydrochloride USP<br>25.50 mg.<br>2<br>Microcrystalline Cellulose<br>(Avicel PH 301)<br>148.80 mg.<br>3<br>Pregelatinized<br>starch<br>(Starch 1500 LM)<br>39.60 mg.<br>4<br>Colloidal silicon dioxide<br>(Aerosil 200 Pharma)<br>2.20 mg.<br>Magnesium<br>Stearate<br>CLOMIPRAMINE HCL CAP USP 25 MG<br>1 Number<br>5<br>4.40 mg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||CLOMIPRAMINE HCL CAP USP 25 MG||1 Number|1<br> <br>|Clomipramine<br>Hydrochloride USP|25.50 mg.| |||||2<br> <br>|Microcrystalline Cellulose<br>(Avicel PH 301)|<br>148.80 mg.| |||||3<br> <br>|Pregelatinized<br>starch<br>(Starch 1500 LM)|<br>39.60 mg.| |||||4<br> <br>|Colloidal silicon dioxide<br>(Aerosil 200 Pharma)|<br>2.20 mg.| |||||<br>5|Magnesium<br>Stearate|<br>4.40 mg.|
48
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br>starch<br>(Starch 1500 LM)|<br>39.60 mg.| |||||4<br> <br>|Colloidal silicon dioxide<br>(Aerosil 200 Pharma)|<br>2.20 mg.| |||||<br>5|Magnesium<br>Stearate|<br>4.40 mg.|
48
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| (Vegetable Source)<br>6<br>Clomipramine<br>Hydrochloride USP<br>51.00 mg.<br>7<br>Microcrystalline Cellulose<br>(Avicel PH 301)<br>210.70 mg.<br>8<br>Pregelatinized<br>starch<br>(Starch 1500 LM)<br>59.40 mg.<br>9<br>Colloidal silicon dioxide<br>(Aerosil 200 Pharma)<br>3.30 mg.<br>CLOMIPRAMINE HCL CAP USP 50 MG<br>1 Number<br>10<br>Magnesium<br>Stearate<br>(Vegetable Source)<br>6.60 mg.<br>11<br>Clomipramine<br>Hydrochloride USP<br>76.50 mg.<br>12<br>Microcrystalline Cellulose<br>(Avicel PH 301)<br>205.45 mg.<br>13<br>Pregelatinized<br>starch<br>(Starch 1500 LM)<br>63.90 mg.<br>14<br>Colloidal silicon dioxide<br>(Aerosil 200 Pharma)<br>3.55 mg.<br>CLOMIPRAMINE HCL CAP USP 75 MG<br>1 Number<br>15<br>Magnesium<br>Stearate<br>(Vegetable Source)<br>7.10 mg.<br>RA concerned may take further necessary action as per above decision of NC. | (Vegetable Source) | ||||
|---|---|---|---|---|---|
| CLOMIPRAMINE HCL CAP USP 50 MG | 1 Number | 6 | Clomipramine<br>Hydrochloride USP | 51.00 mg. | |
| 7 | Microcrystalline Cellulose<br>(Avicel PH 301) | <br>210.70 mg. | |||
| 8 | Pregelatinized<br>starch<br>(Starch 1500 LM) | <br>59.40 mg. | |||
| 9 | Colloidal silicon dioxide<br>(Aerosil 200 Pharma) | <br>3.30 mg. | |||
| 10 | Magnesium<br>Stearate<br>(Vegetable Source) | <br>6.60 mg. | |||
| CLOMIPRAMINE HCL CAP USP 75 MG | 1 Number | 11 | Clomipramine<br>Hydrochloride USP | 76.50 mg. |
ioxide<br>(Aerosil 200 Pharma)|<br>3.30 mg.| ||||10|Magnesium<br>Stearate<br>(Vegetable Source)|<br>6.60 mg.| ||CLOMIPRAMINE HCL CAP USP 75 MG|1 Number|11|Clomipramine<br>Hydrochloride USP|76.50 mg.| ||||12|Microcrystalline Cellulose<br>(Avicel PH 301)|<br>205.45 mg.| ||||13|Pregelatinized<br>starch<br>(Starch 1500 LM)|<br>63.90 mg.| ||||14|Colloidal silicon dioxide<br>(Aerosil 200 Pharma)|<br>3.55 mg.| ||||15|Magnesium<br>Stearate<br>(Vegetable Source)|<br>7.10 mg.|
| Case No. | 81 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | GLOBAL CALCIUM PRIVATE LIMITED |
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| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
|---|---|
| HQ File Number | HQRNORM APPLY 00299344AM22 |
| RA File Number | 07AA04038998 AM22 |
| Licence No and<br>Date | 0711002737/28/12/2021 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm was asked to give<br>Chemical reaction of the process with yield, and production/consumption data of specific items of export,<br>several times but they have not given the same. Due to this, the Committee decided to call the firm for<br>attending Personal Hearing<br>before Norms Committee to explain its case. |
ort,<br>several times but they have not given the same. Due to this, the Committee decided to call the firm for<br>attending Personal Hearing<br>before Norms Committee to explain its case.||
| Case No. | 82 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | PANACEA BIOTEC PHARMA LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00005946AM24 |
| RA File Number | 05AX04000321 AM22 |
| Licence No and<br>Date | 0511007823/11/01/2022 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to refer the case toDeptt. of Bio-<br>Technologyfor obtaining their comments. |
| Case No. | 83 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Rejected |
| Party Name | LAXMI ORGANIC INDUSTRIES LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00006821AM24 |
| RA File Number | 038504000145 AM21 |
| Licence No and<br>Date | 0311010587/17/01/2022 |
| Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, it was decided toreject |
50 This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-07-2024 10:03:09.
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the case maintaining the status quo.
Hence, it was decided toreject||
50 This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-07-2024 10:03:09.
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the case maintaining the status quo.
| Case No. | 84 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Approved |
| Party Name | AURORE LIFE SCIENCES PRIVATE LIMITED |
| Meeting Number and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM APPLY 00345828AM22 |
| RA File Number | 09AX04000205 AM22 |
| Licence No and Date | 0911002465/07/02/2022 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>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. No. Import Items<br>Qty.<br>allowed.<br>1<br>4-CHLORO-7H PYRROLO[2,3-D]PYRIMIDINE<br>1.00 kg.<br>Tofacitinib Citrate<br>1 kg.<br>2<br>(3R,4R)-N,4-DIMETHYL -1-<br>(PHENYLMETHYL) -3-<br>PIPERIDINAMINEHYDROCHLORIDE<br>1.72 kg.<br>RA concerned may take further necessary action as per above decision of NC. |
| Case No. | 85 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Approved |
| Party Name | SUN PHARMACEUTICAL INDUSTRIES LIMITED |
| Meeting Number and<br>Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM APPLY 00350237AM22 |
| RA File Number | 05AX04000943 AM22 |
| Licence No and Date | 0511008753/10/02/2022 |
51
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Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
a. Norms for 1 Number Tablet.
| Bulk Drug | Quantity in mg. | Quantity in mg. |
|---|---|---|
| Export item no.1 | Export item no.2 | |
| Buprenorphine Hydrochloride | 2.04 mg. | 8.16 mg. |
| Naloxone Hydrochloride | 0.51 mg. | 2.04 mg. |
- b. Raw Material proposed for 1 kg. Buprenorphine Hydrochloride
| Export Product | Qty. | **Sl. No. ** | Import Items | Qty. allowed. | |
|---|---|---|---|---|---|
| Buprenorphine Hydrochloride | 1 kg. | 1 | 7(Alpha)-(2-Hydroxy-3,3- | 1.955 kg. | |
| Dimethyl-2-Butyl)-6, | 14- | ||||
| Endo-Ethano-6, 7, 8, | 14- | ||||
| Tetrahydronorthebaine | |||||
| 2 | Cyclopropyl methanol | 1.60 kg. | |||
| 3 | Methane Sulfonyl Chloride | 2.50 kg. | |||
| 4 | Lithium Bromide | 2.00 kg. | |||
| 5 | Thiophenol | 2.50 kg. | |||
| 6 | Dimethyl Formamide | 4.00 kg. |
52 This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-07-2024 10:03:09.
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| 7 | Triethyl Amine | Triethyl Amine | 4.80 kg. | |||
|---|---|---|---|---|---|---|
| 8 | Toluene | 20.50 kg. | ||||
| 9 | Methanol | 5.50 kg. | ||||
| 10 | Activated | Carbon | / | Eno | <br>0.200 kg. | |
| Carbon | ||||||
| 11 | Acetone | 4.50 kg. |
- c. Raw Material proposed for 1 kg. Naloxone Hydrochloride
| Export Product | Qty. | **Sl. No. ** | Import Items | Qty. allowed. |
|---|---|---|---|---|
| Naloxone Hydrochloride | 1 kg. | 12 | Noroxymorphone | 1.23 kg. |
| 13 | Methylene Chloride | 7.45 kg. |
Note: RA may work-out the import entitlement of all inputs as per (a), (b) & (c) above on pro-rata basis.
RA concerned may take further necessary action as per above decision of NC
45 kg.|
Note: RA may work-out the import entitlement of all inputs as per (a), (b) & (c) above on pro-rata basis.
RA concerned may take further necessary action as per above decision of NC
| Case No. | 86 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | GANGWAL HEALTHCARE PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM APPLY 00356909AM22 |
| RA File Number | 03AX04001205 AM22 |
| Licence No and | 0311011422/16/02/2022 |
53 This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-07-2024 10:03:09.
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Date
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it was decided to call for following information/documents from the firm:-
-
Export description is vogue and does not indicate percentage DHA in export.
-
Import item No.1 is confusing as it does not indicate percentage Assay.
-
Whether import and export are Oil Powder. If so, please get the licence amended as per 1 to 3 above.
ort.**
-
Import item No.1 is confusing as it does not indicate percentage Assay.
-
Whether import and export are Oil Powder. If so, please get the licence amended as per 1 to 3 above.
| Case No. | 87 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Rejected |
| Party Name | LAXMI ORGANIC INDUSTRIES LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00006822AM24 |
| RA File Number | 03AX04000957 AM22 |
| Licence No and<br>Date | 0311011997/28/02/2022 |
| Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, it was decided toreject<br>the case maintaining thestatus quo. |
| Case No. | 88 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | KRITI NUTRIENTS LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00001037AM25 |
| RA File Number | 56AX04000172 AM23 |
| Licence No and<br>Date | 5611001168/15/09/2022 |
| Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of |
54 This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-07-2024 10:03:09.
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the TE, it was decided to call for following information/documents from the firm:-
Complete Certificate of Analysis (CoA) of import items from Foreign Supplier.
| Case No. | 89 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Approved |
| Party Name | CANPEX CHEMICALS PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM APPLY 00003225AM23 |
| RA File Number | 31AX04000170 AM23 |
| Licence No and<br>Date | 3111001703/20/09/2022 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>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. No. Import Items<br>Qty. allowed.<br>CYANAMIDE 50% SOLUTION<br>1 kg.<br>1<br>CALCIUM CYANAMIDE<br>(Purity 63% as per CoA)<br>1.913 kg.<br>RA concerned may take further necessary action as per above decision of NC. |
| Case No. | 90 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | BLUE JET HEALTHCARE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM APPLY 00003358AM23 |
| RA File Number | 03AX04002988 AM23 |
55
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Licence No and 0311018145/25/09/2022 Date Norms Committee Decision: The case is under consideration and TE was requested to expedite their comments.
AX04002988 AM23|
55
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Licence No and 0311018145/25/09/2022 Date Norms Committee Decision: The case is under consideration and TE was requested to expedite their comments.
| Case No. | 91 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | KRITI NUTRIENTS LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00001038AM25 |
| RA File Number | 56AX04000363 AM23 |
| Licence No and<br>Date | 5611001525/02/02/2023 |
| Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of<br>the TE, it was decided to call for following information/documents from the firm:-<br>Complete Certificate of Analysis (CoA) of import items from Foreign Supplier. |
| Case No. | 92 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Approved |
| Party Name | OC SPECIALITIES PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00001133AM25 |
| RA File Number | 03AX04000744 AM24 |
| Licence No and<br>Date | 0311023755/20/05/2023 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to revise ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- |
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. 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. allowed. | |
|---|---|---|---|---|---|
| 2, | 6-Dichloro Benzoyl chloride | 1 kg. | 1 | 2,6-Dichloro Benzaldehyde | 1.185 kg. |
| Case No. | 93 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | VIRCHOW PETROCHEMICAL PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00001056AM25 |
| RA File Number | 09AX04000845 AM23 |
| Licence No and<br>Date | 0911005139/01/06/2023 |
| Norms Committee Decision:<br>The Committee considred the case as per agenda and it was observed that norms apply in the two<br>advance licences are different and the firm has now represented against the norms ratified by the<br>committee on the basis of comparative data for above referred licences. The Committee also observed<br>that there is still confusion in the import quantity for key raw material i.e._Pencilin G_as the firm has not<br>so far get their licence amended for higher norms.<br>The Committee felt that the firm may be called forPersonal Hearingand explain their case in details<br>alongwith necessary documents. The firm is also advised to bring actual production/consumption data<br>relevant to these two licence separately alongwith copy of Shipping Bills and Bill of Entry. |
ongwith necessary documents. The firm is also advised to bring actual production/consumption data<br>relevant to these two licence separately alongwith copy of Shipping Bills and Bill of Entry.||
| Case No. | 94 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | VIRCHOW PETROCHEMICAL PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00001053AM25 |
| RA File Number | 09AX04000025 AM24 |
| Licence No and | 0911005223/19/06/2023 |
57
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Date
Norms Committee Decision:
The Committee considred the case as per agenda and it was observed that norms apply in the two advance licences are different and the firm has now represented against the norms ratified by the committee on the basis of comparative data for above referred licences. The Committee also observed that there is still confusion in the import quantity for key raw material i.e. Pencilin G as the firm has not so far get their licence amended for higher norms.
The Committee felt that the firm may be called for Personal Hearing and explain their case in details alongwith necessary documents. The firm is also advised to bring actual production/consumption data relevant to these two licence separately alongwith copy of Shipping Bills and Bill of Entry.
| Case No. | 95 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Rejected |
| Party Name | SRI KRISHNA PHARMACEUTICALS LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00000801AM25 |
| RA File Number | 09AX04000551 AM24 |
| Licence No and<br>Date | 0911005810/20/09/2023 |
| Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, it was decided toreject<br>the case maintaining thestatus quo. |
ms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, it was decided toreject<br>the case maintaining thestatus quo.||
| Case No. | 96 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Rejected |
| Party Name | LINCOLN PHARMACEUTICALS LTD |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00000899AM25 |
| RA File Number | 08AX04001563 AM24 |
| Licence No and<br>Date | 0811009996/20/11/2023 |
| Norms Committee Decision: |
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The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm has not provided any technical justification / information for enhancement. Hence, it was decided to reject the case maintaining the status quo.
| Case No. | 97 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | KALPSUTRA CHEMICALS PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00000628AM25 |
| RA File Number | 03AX04003995 AM24 |
| Licence No and<br>Date | 0311029148/06/12/2023 |
| Norms Committee Decision: | |
| The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of | |
| the TE, it was decided to call for following information/documents from the firm:- | |
| Certificate of Analysis (CoA) of import item indicating percentage content of Alpha Pinen.<br>1. |
vise of|| |the TE, it was decided to call for following information/documents from the firm:-|| |Certificate of Analysis (CoA) of import item indicating percentage content of Alpha Pinen.<br>1.|| |Prodeuction/consumption data duly certified by Auditor of the firm.<br>2.|| |Percentage puriety of import and export.<br>3.||
| Case No. | 98 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Rejected |
| Party Name | USV PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00000727AM25 |
| RA File Number | 03AX04004322 AM24 |
| Licence No and<br>Date | 0311029676/27/12/2023 |
| Norms Committee Decision: | |
| The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm | |
| has not provided any technical justification / information for enhancement. Hence, it was decided toreject | |
| the case maintaining thestatus quo. |
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Hence, it was decided toreject|| |the case maintaining thestatus quo.||
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| Case No. | 99 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Rejected |
| Party Name | USV PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00001103AM25 |
| RA File Number | 03AX04004600 AM24 |
| Licence No and<br>Date | 0311030078/10/01/2024 |
| Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, it was decided toreject<br>the case maintaining thestatus quo. |
| Case No. | 100 / NC/3/MEET/Jun/202425/5 |
|---|---|
| Case Status | Case Deferred |
| Party Name | TIDE INDUSTRIES |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Jun/ 202425/ 5 and 14/06/2024 |
| HQ File Number | HQRNORM REVIW00000622AM25 |
| RA File Number | 34AX04000854 AM24 |
| Licence No and<br>Date | 3411004626/16/02/2024 |
| Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of<br>the TE, it was decided to call for following information/documents from the firm:-<br> Percentae puriety of import and export alongwith Certificatge of Analysis (CoA).<br>1.<br>Production / consumption data duty certified by Auditor of the firm.<br>2.<br>Percentage yield of reaction and fractional distillation.<br>3. |
h Certificatge of Analysis (CoA).**<br>1.<br>Production / consumption data duty certified by Auditor of the firm.<br>2.<br>Percentage yield of reaction and fractional distillation.<br>3.||
60 This document has been digitally signed by Raman Kumar, Deputy DGFT on 15-07-2024 10:03:09.
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