IN FORCE Advance Authorisation

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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 : egtf-dgft@gov.in , Phone Office : 011-23062777

(DES - III SECTION)

Meeting No - NC/3/MEET/Aug/202526/7 Meeting Date - 22/08/2025

Minutes of the Norms Committee–3 Meeting No.NC/3/MEET/Aug/202526/7 dated 22/08/2025 under the Chairmanship of Shri Rakesh Kumar, Addl. DGFT for considering the cases/issues under the Duty Exemption Scheme (Chapter-4) of the Foreign Trade Policy, 2023, pertaining to Chemical and Allied products falling under Chapters 29 and 30.

2. The following members were present in the Meeting:-

Sl. No.	Name & Designation	Department
1	Shri Dinesh Narain Mathur, Technical Expert	Consultant (Pharma)
2	Shri Shaish Kumar, Technical Expert	Consultant (Chemical)
3	Shri Nand Lal, Technical Expert	Consultant (Chemical)
In attendance:
1	Shri Raman Kumar, Deputy DGFT	DGFT (HQ)
2	Smt. Skina Rani, FTDO	DGFT (HQ)

Signature Not Verified Signature Not Verified Digitally Signed. Digitally signa, Name: RAMAN KUMAR( Deputy Name: RAMAN KUJAAR( Deputy DGFT ) DGFT Date: 16-Sep-2025 15:17:18 Date: )16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ) Location:Reason: ramaniagmar@nic.inDGFTTHQ)

This document has been digitally signed by Raman Kumar, Deputy DGFT,DGFT(HQ) on 16-Sep-2025.

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    The Norms Committee has taken decisions only with respect to technical aspect/ wastage norms. While redeeming the application, RAs should check that the applicant has fulfilled all requirements as prescribed in policy/procedure, including those in notifications, public notices and policy circulars issued from time to time or any other provisions under FTP/HBP for issuance of Advance Authorization and regularisation of the case.

    RAs shall ensure compliance with SION, General Notes and Chapter Notes wherever applicable.

ovisions under FTP/HBP for issuance of Advance Authorization and regularisation of the case.

    RAs shall ensure compliance with SION, General Notes and Chapter Notes wherever applicable.

    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 with the provisions of Para 4.12 of FTP, Para 4.16, Para 4.21, and Para 4.51 of HBP shall be made.

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	HEMA DYECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00002356AM26
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee decided to seek production consumption data of 2–3 manufacturers of the export product_4_<br>Chloro 2-5 Dimethoxy Aniline. Chemexcil may also be requested to provide production and consumption<br>data in respect of at least 2–3 manufacturers of the above item.

Case No.	2 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	ANUPAM RASAYAN INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	018205000924AM10
RA File Number	522404000031 AM10
Licence No and<br>Date	5210029505/27/01/2010
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	3 / NC/3/MEET/Aug/202526/7
Case Status	Case Approved
Party Name	NECTAR LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM REVIW00001482AM25
RA File Number	222404000083 AM14
Licence No and<br>Date	2210015019/15/07/2014

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

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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:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Cefuroxime Axetil Coated	1 kg.	1	7-ACA	0.541 kg.
		2	Ethyl Acetate	2.586 kg.
		3	Methanol	0.639 kg.
		4	SMIA	0.433 kg.
		5	Activated Carbon	0.20 kg.
		6	Phosphorus Pentachloride	0.526 kg.
		7	Methylene Chloride	2.945 kg.
		8	Acetic acid	0.032 kg.
		9	Acetonitrile	0.285 kg.
		10	Chlorosulphonyl Isocyanate	0.334 kg.
		11	Acetone	1.659 kg.
		12	Dimethyl acetamide	0.488 kg.
		13	Cyclohexane	0.135 kg.

RA concerned may take further necessary action as per above decision of NC.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

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r necessary action as per above decision of NC.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Case No.	4 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	BELOORBAYIR BIOTECH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM REVIW00007896AM24
RA File Number	072404000347 AM16
Licence No and<br>Date	0710109255/12/01/2016
Norms Committee Decision:<br>The Committee considered the case as per agenda and the Committee observed that import item are not as<br>per Drug Manufacturing License/FASSAI certificate, therefore, it was decided to call the firm for attending<br>Personal Hearingbefore Norms Committee to explain its case along with relevant information /<br>documents, sample, COA of each import items.

Case No.	5 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	SHREE BANKEY BEHARI LAL FLAVORS
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
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, Delhi was requested vide DGFT (HQ) letter dated 11/06/2024 to<br>the audit firm’s records and submit production/consumption data for the year 2018-2019 as sought by the<br>Technical Expert to be submitted within fifteen days of receipt of said letter;

6/2024 to the audit firm’s records and submit production/consumption data for the year 2018-2019 as sought by the Technical Expert to be submitted within fifteen days of receipt of said letter; however, no such response has been received from CLA, Delhi. A D.O. letter dated 22/10/2024 in this regard was sent to the CLA with the request to expedite the matter. The response from CLA, Delhi, is still awaited. The Committee decided to resend another DO Letter to the Head of CLA again to expedite the matter.||

Case No.	6 / NC/3/MEET/Aug/202526/7
Case Status	Case Approved
Party Name	SHUBHLAXMI INDUSTRIES

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM REVIW00002134AM25
RA File Number	082404000267 AM19
Licence No and<br>Date	0810144119/20/12/2018
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<br>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>Sulpho Gamma Acid<br>1 kg.<br>1<br>K ACID<br>1.50 kg.<br>RA concerned may take further necessary action as per above decision of NC.

** Sl. No. Import Items Qty. allowed. Sulpho Gamma Acid 1 kg. 1 K ACID 1.50 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	7 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	KEVA FRAGRANCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	018205000499AM20
RA File Number	039404000373 AM20
Licence No and<br>Date	0310830887/07/08/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Hearing<br> before Norms Committee to explain its case along with relevant information / documents<br>firm.		Personal<br>from the

Case No.	8 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM REVIW00000048AM25
RA File Number	318304000087 AM20
Licence No and<br>Date	3110067548/30/09/2019
Norms Committee Decision:<br>The firm was called for Personal Hearing on 22.08.2025 through Video Conference, but the firm could not<br>appear before Norms Committee. It was decided to grant one more opportunity to the firm forPersonal<br>Hearing<br> with relevant documents/information.

ideo Conference, but the firm could not appear before Norms Committee. It was decided to grant one more opportunity to the firm forPersonal Hearing with relevant documents/information.||

Case No.	9 / NC/3/MEET/Aug/202526/7
Case Status	Case Rejected
Party Name	SAVLA CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM REVIW00002129AM25
RA File Number	039504000192 AM21
Licence No and<br>Date	0310837078/08/07/2020
Norms Committee Decision:<br>The Committee examined the firm’s request for fixation of ad-hoc norms and observed that the export and<br>import items are identical, with no value addition in the manufacturing of the export product. Accordingly,<br>the Committee decided torejectthe firm’s application.

Case No.	10 / NC/3/MEET/Aug/202526/7
Case Status	Case Rejected
Party Name	KOSHA CHEMTECH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM REVIW00000014AM25
RA File Number	039404000306 AM21
Licence No and<br>Date	0310837580/10/08/2020
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, the committee didn’t

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

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or enhancement. Hence, the committee didn’t||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

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find any merit to review the norms and it was decided to reject the case maintaining the status quo.

Case No.	11 / NC/3/MEET/Aug/202526/7
Case Status	Case Approved
Party Name	FRESENIUS KABI ONCOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00140720AM22
RA File Number	05AA04055023 AM22
Licence No and<br>Date	0511003699/16/07/2021
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 item in meeting No.NC/3/MEET/Apr/202425/2 dated 30/04/2024 against advance<br>authorization No. 0510415659 dated 27/10/2020, 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.<br>Import Items<br>Qty. allowed.<br>1<br>Platinum (Sponge Powder)<br>0.85 kg.<br>Oxaliplatin<br>(Anti Cancer Bulk Drug)<br>1 kg.<br>2<br>(1R,2R)-(-)-1,2-Diamino cyclo hexane.<br>0.49 kg.<br>RA concerned may take further necessary action as per above decision of NC.

85 kg. Oxaliplatin (Anti Cancer Bulk Drug) 1 kg. 2 (1R,2R)-(-)-1,2-Diamino cyclo hexane. 0.49 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	12 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	VASISTA LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00004049AM23
RA File Number	09AX04000675 AM23
Licence No and	0911003903/03/11/2022

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Norms Committee Decision:

The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE, it was decided to call for following information/documents from the firm:-

As per the details given in the application, Tetrahydrofuran (THF) is solvent and to confirm the content of THF contained in both the exsport items, separately and accordingly, to submit the Certificate of Analysis (CoA) report of both export items.
Recovery/recycle details of THF in the process, indicating its calculation of requirement.
The percentage of THF is going to the effluent treatment plant.

Case No.	13 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	JUBILANT INGREVIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00005825AM23
RA File Number	05AX04003069 AM23
Licence No and<br>Date	0511016941/19/01/2023
Norms Committee Decision:<br>The Committee considered the agenda item and decided to call the firm for aPersonal Hearing<br> before the<br>Norms Committee to present its case, along with the requisite information and supporting documents.

nsidered the agenda item and decided to call the firm for aPersonal Hearing before the Norms Committee to present its case, along with the requisite information and supporting documents.|||

Case No.	14 / NC/3/MEET/Aug/202526/7
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00005897AM23
RA File Number	34AX04000965 AM23
Licence No and<br>Date	3411003278/24/01/2023
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 item in meeting No.NC/3/MEET/Feb/202425/17 dated 25/02/2025 against advance<br>authorization No.3411003805 dated 15/06/2023 , it was decided to fix ad-hoc norms under Para 4.07 of

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

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HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

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HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

|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. 1 Doxycycline Monohydrate USP 82.26 mg 2 Microcrystalline Cellulose (Avicel PH 301) 88.874 mg. 3 Sodium Starch Glycolate (Type A) (EXPLOTAB) 12.75 mg. 4 Povidone (Kollidon30 LP) 6.00 mg. 5 Microcrystalline Cellulose (Avicel PH 200 LM) 15.00 mg. 6 Colloidal Silicon Dioxide (Aerosil 200 Pharma) 1.088 mg. Doxycycline Caps. USP 75 mg. 1 Number 7 Magnesium Stearate (Vegetable Source) 2.25 mg. 8 Doxycycline Monohydrate USP 109.68 mg. 9 Microcrystalline Cellulose (Avicel PH 301) 118.498 mg. 10 Sodium Starch Glycolate (Type A) (EXPLOTAB) 17.00 mg. 11 Povidone (Kollidon30 LP) 8.00 mg. 12 Microcrystalline Cellulose (Avicel PH 200 LM) 20.00 mg. 13 Colloidal Silicon Dioxide (Aerosil 200 Pharma) 1.45 mg. Doxycycline Caps. USP 100 mg 1 Number 14 Magnesium Stearate (Vegetable Source) 3.00 mg.|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.

e (Vegetable Source) 3.00 mg.|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. 1 Doxycycline Monohydrate USP 82.26 mg 2 Microcrystalline Cellulose (Avicel PH 301) 88.874 mg. 3 Sodium Starch Glycolate (Type A) (EXPLOTAB) 12.75 mg. 4 Povidone (Kollidon30 LP) 6.00 mg. 5 Microcrystalline Cellulose (Avicel PH 200 LM) 15.00 mg. 6 Colloidal Silicon Dioxide (Aerosil 200 Pharma) 1.088 mg. Doxycycline Caps. USP 75 mg. 1 Number 7 Magnesium Stearate (Vegetable Source) 2.25 mg. 8 Doxycycline Monohydrate USP 109.68 mg. 9 Microcrystalline Cellulose (Avicel PH 301) 118.498 mg. 10 Sodium Starch Glycolate (Type A) (EXPLOTAB) 17.00 mg. 11 Povidone (Kollidon30 LP) 8.00 mg. 12 Microcrystalline Cellulose (Avicel PH 200 LM) 20.00 mg. 13 Colloidal Silicon Dioxide (Aerosil 200 Pharma) 1.45 mg. Doxycycline Caps. USP 100 mg 1 Number 14 Magnesium Stearate (Vegetable Source) 3.00 mg.|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.

e (Vegetable Source) 3.00 mg.|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. 1 Doxycycline Monohydrate USP 82.26 mg 2 Microcrystalline Cellulose (Avicel PH 301) 88.874 mg. 3 Sodium Starch Glycolate (Type A) (EXPLOTAB) 12.75 mg. 4 Povidone (Kollidon30 LP) 6.00 mg. 5 Microcrystalline Cellulose (Avicel PH 200 LM) 15.00 mg. 6 Colloidal Silicon Dioxide (Aerosil 200 Pharma) 1.088 mg. Doxycycline Caps. USP 75 mg. 1 Number 7 Magnesium Stearate (Vegetable Source) 2.25 mg. 8 Doxycycline Monohydrate USP 109.68 mg. 9 Microcrystalline Cellulose (Avicel PH 301) 118.498 mg. 10 Sodium Starch Glycolate (Type A) (EXPLOTAB) 17.00 mg. 11 Povidone (Kollidon30 LP) 8.00 mg. 12 Microcrystalline Cellulose (Avicel PH 200 LM) 20.00 mg. 13 Colloidal Silicon Dioxide (Aerosil 200 Pharma) 1.45 mg. Doxycycline Caps. USP 100 mg 1 Number 14 Magnesium Stearate (Vegetable Source) 3.00 mg.| |---|---|---|---|---|---| ||Export Product|Qty.|Sl. No.|Import Items|Qty. allowed.| ||Doxycycline Caps.

1 Number 14 Magnesium Stearate (Vegetable Source) 3.00 mg.| |---|---|---|---|---|---| ||Export Product|Qty.|Sl. No.|Import Items|Qty. allowed.| ||Doxycycline Caps. USP 75 mg.|1 Number|1|Doxycycline Monohydrate USP|82.26 mg| ||||2|Microcrystalline Cellulose (Avicel PH 301)|88.874 mg.| ||||3|Sodium Starch Glycolate (Type A) (EXPLOTAB)|12.75 mg.| ||||4|Povidone (Kollidon30 LP)|6.00 mg.| ||||5|Microcrystalline Cellulose (Avicel PH 200 LM)|15.00 mg.| ||||6|Colloidal Silicon Dioxide (Aerosil 200 Pharma)|1.088 mg.| ||||7|Magnesium Stearate (Vegetable Source)|2.25 mg.| ||Doxycycline Caps. USP 100 mg|1 Number|8|Doxycycline Monohydrate USP|109.68 mg.| ||||9|Microcrystalline Cellulose (Avicel PH 301)|118.498 mg.| ||||10|Sodium Starch Glycolate (Type A) (EXPLOTAB)|17.00 mg.| ||||11|Povidone (Kollidon30 LP)|8.00 mg.| ||||12|Microcrystalline Cellulose (Avicel PH 200 LM)|20.00 mg.| ||||13|Colloidal Silicon Dioxide (Aerosil 200 Pharma)|1.45 mg.| ||||14|Magnesium Stearate (Vegetable Source)|3.00 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

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ium Stearate (Vegetable Source)|3.00 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Case No.	15 / NC/3/MEET/Aug/202526/7
Case Status	Case Approved
Party Name	SCL LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00006594AM23
RA File Number	30AX04000547 AM23
Licence No and<br>Date	3011003202/24/02/2023
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<br>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>Ketoprofen<br>35000.0 kg.<br>2<br>N-octyl-D-Glucamine<br>12600.0 kg.<br>3<br>Tris Amino Buffer Tromethamine<br>12600.0 kg.<br>Dexketoprofen Trometamol<br>35000 kg.<br>4<br>Ethyl Acetate<br>Indiginiously<br>procured.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	16 / NC/3/MEET/Aug/202526/7
Case Status	Case Approved
Party Name	MAHARASHTRA ALDEHYDES AND CHEMICALS LTD
Meeting Number	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

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r|NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

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and Date
HQ File Number	HQRNORM APPLY 00006735AM23
RA File Number	03AX04004601 AM23
Licence No and<br>Date	0311021876/03/03/2023
Norms Committee Decision:<br>The Committee considered the case as per the agenda, and it was observed that the firm has amended the<br>export product in the Advance Authorisation as sought by the Committee earlier in the meeting held on<br>04/06/2025. Therefore, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I, as per details<br>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>Citric Acid Anhydrous (Powder)<br>0.7322 kg.<br>Triethyl Citrate<br>1 kg.<br>2<br>Ethanol (Liquid)<br>0.5263 kg.<br>RA concerned may take further necessary action as per above decision of NC.

br>Citric Acid Anhydrous (Powder) 0.7322 kg. Triethyl Citrate 1 kg. 2 Ethanol (Liquid) 0.5263 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	17 / NC/3/MEET/Aug/202526/7	17 / NC/3/MEET/Aug/202526/7	17 / NC/3/MEET/Aug/202526/7	17 / NC/3/MEET/Aug/202526/7	17 / NC/3/MEET/Aug/202526/7
Case Status		Case Approved
Party Name		MEDREICH LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number		HQRNORM APPLY 00006767AM23
RA File Number		07AX04001781 AM23
Licence No and<br>Date		0711006639/06/03/2023
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<br>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.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Sl. No.**|Import Items|Qty. allowed.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

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1	Urapidil (Urapidil IH [micronized 25<br>microns])	61.20 mg.
2	Sugar Spheres (Sugar Spheres 20-25<br>[PHARM A SPHER PEL NEUT 20-<br>25M])	120.0 mg.
3	Duma Twist Off Container<br>[50 ml / 35 mm HDPE Container]	Net to Net with<br>accountibility
4	Duma Twist Off Closure with Integrated<br>2G Desiccant<br>[35mm Round Cap with 2G Desiccant]	Net to Net with<br>accountibility

ml / 35 mm HDPE Container]|Net to Net with accountibility| ||||4|Duma Twist Off Closure with Integrated 2G Desiccant [35mm Round Cap with 2G Desiccant]|Net to Net with accountibility|

|Case No.|Case No.|18 / NC/3/MEET/Aug/202526/7|18 / NC/3/MEET/Aug/202526/7|18 / NC/3/MEET/Aug/202526/7|18 / NC/3/MEET/Aug/202526/7|18 / NC/3/MEET/Aug/202526/7|
|---|---|---|---|---|---|---|
|Case Status||Case Approved|||||
|Party Name||ATUL LIMITED|||||
|Meeting Number<br>and Date||NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025|||||
|HQ File Number||HQRNORM REVIW00006563AM24|||||
|RA File Number||08AX04001977 AM23|||||
|Licence No and<br>Date||0811007532/10/03/2023|||||
|Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under:-<br>**Export Product**<br>**Qty.**<br>**Sl. No.**<br>**Import Items**<br>**Qty. allowed.**<br>1<br>Aniline | Aniline Oil<br>0.683 kg.<br>Di Ethyl Toluene Diamine | Ethacure 100 |<br>Formulated Aromatic Amine<br>1<br>1 kg.<br>2<br>0.167 kg.|||||||
||**Export Product**||**Qty.**|**Sl. No.**|**Import Items**|**Qty. allowed.**|
||Formulated Aromatic Amine<br>1||<br>1 kg.|1|Aniline | Aniline Oil|0.683 kg.|
|||||2|Di Ethyl Toluene Diamine | Ethacure 100 ||0.167 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

luene Diamine | Ethacure 100 ||0.167 kg.|





Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ) 


13 

UDIN00304919AM26 

```text
|||Lonzacure DETDA 80 | DETDA 80 | DETDA||
|---|---|---|---|
||3|Iso Phoron Diamine | Vestamine IPD | Baxxodur|0.101 kg.|
|||EC 201 | Wanamine IPDA||

Case No.	Case No.	19 / NC/3/MEET/Aug/202526/7	19 / NC/3/MEET/Aug/202526/7	19 / NC/3/MEET/Aug/202526/7	19 / NC/3/MEET/Aug/202526/7	19 / NC/3/MEET/Aug/202526/7
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number		HQRNORM APPLY 00000850AM24
RA File Number		34AX04000113 AM24
Licence No and<br>Date		3411003716/15/05/2023
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 item in meeting No. NC/3/MEET/Feb/202425/17 dated 25/02/2025 against advance<br>authorization No.3411003871 dated 06/07/2023,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 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. 1 Acitretin USP 10.2 mg 2 Microcrystalline cellulose (Avicel PH 102) 54.6 mg. 3 Colloidal silicon dioxide (Aerosil 200 Pharma) 0.30 mg. Acitretin Capsules USP 10 mg 1 Number 4 Magnesium stearate (Ligamed MF-2-V) 0.60 mg. 5 Acitretin USP 17.85 mg. Acitretin Capsules USP 17.5 mg 1 Number||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Acitretin Capsules USP 10 mg||1 Number|1|Acitretin USP|10.2 mg| |||||2|Microcrystalline cellulose (Avicel PH 102)|54.6 mg.| |||||3|Colloidal silicon dioxide (Aerosil 200 Pharma)|0.30 mg.| |||||4|Magnesium stearate (Ligamed MF-2-V)|0.60 mg.| ||Acitretin Capsules USP 17.5 mg||1 Number|5|Acitretin USP|17.85 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

17.5 mg||1 Number|5|Acitretin USP|17.85 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

		6	Microcrystalline cellulose (Avicel PH<br>102)	95.55 mg.
		7	Colloidal silicon dioxide (Aerosil 200<br>Pharma)	0.70 mg.
		8	Magnesium stearate (Ligamed MF-2-V)	1.00 mg.
Acitretin Capsules USP 25 mg	1 Number	9	Acitretin USP	25.50 mg.
		10	Microcrystalline cellulose (Avicel PH<br>102)	136.50 mg.
		11	Colloidal silicon dioxide (Aerosil 200<br>Pharma)	1.00 mg.
		12	Magnesium stearate (Ligamed MF-2-V)	1.40 mg.

25.50 mg.| ||||10|Microcrystalline cellulose (Avicel PH 102)|136.50 mg.| ||||11|Colloidal silicon dioxide (Aerosil 200 Pharma)|1.00 mg.| ||||12|Magnesium stearate (Ligamed MF-2-V)|1.40 mg.|

Case No.	20 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	AGRO SOLVENT PRODUCTS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00001107AM24
RA File Number	56AX04000449 AM23
Licence No and<br>Date	5611001909/25/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearing<br>before Norms Committee to explain its case along with following information / documents from the firm:<br>Certificate of Analysis (CoA) of import item from Foreign Supplier.<br>1.<br>Manufacturing process for each export item.<br>2.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

turing process for each export item. 2.|||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

Case No.	21 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	OAN INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00001150AM24
RA File Number	13AX04000047 AM24
Licence No and<br>Date	1311001965/26/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearing<br>before Norms Committee to explain its case along with following information / documents from the firm:<br>Complete technical details as per Annexure to Appendix-4E for each export item separately.<br>1.<br>Manufacturing process in details for each export item with molecular weight, chemistry, percentage<br>yield of reaction and Stichiometric Balance.<br>2.

or each export item separately. 1. Manufacturing process in details for each export item with molecular weight, chemistry, percentage yield of reaction and Stichiometric Balance. 2.|||

Case No.	22 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	KELVIN NATURAL MINT PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00004732AM24
RA File Number	05AX04001031 AM24
Licence No and<br>Date	0511019800/31/07/2023
Norms Committee Decision:<br>The firm was called for Personal Hearing on 22.08.2025 through Video Conference, but the firm could not<br>appear before Norms Committee. It was decided to grant one more opportunity to the firm forPersonal<br>Hearing<br> with relevant documents/information.

Case No.	23 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

ty Name|FRESENIUS KABI INDIA PRIVATE LIMITED|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00004957AM24
RA File Number	03AX04002106 AM24
Licence No and<br>Date	0311026174/09/08/2023
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 with sampel of export and import items such as import item (i)<br>BOP Infusion, (ii) BOP Injection, (iii) SSC Infusion and (iv) SSC Injection.

|Case No.|24 / NC/3/MEET/Aug/202526/7|
|---|---|
|Case Status|Case Approved|
|Party Name|ATUL LIMITED|
|Meeting Number<br>and Date|NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025|
|HQ File Number|HQRNORM APPLY 00005075AM24|
|RA File Number|08AX04000894 AM24|
|Licence No and<br>Date|0811009108/16/08/2023|
|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<br>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.

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:-<br>**Export Product**<br>**Qty.**<br>**Sl. No.**<br>**Import Items**<br>**Qty. allowed.**<br>1<br>Isophorone Diamine | (Vestamine IPD |<br>Baxxodur EC 201| Wanamine IPDA)<br>0.520 kg.<br>2<br>Bisphenol-A<br>0.090 kg.<br>Cycloaliphatic Amine<br>Adduct<br>1 kg.<br>3<br>Epichlorohydrin<br>0.072 kg.<br>RA concerned may take further necessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

Case No.	25 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	STANEX DRUGS AND CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00005456AM24
RA File Number	09AX04000507 AM24
Licence No and<br>Date	0911005765/05/09/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to refer the case to<br>Technology<br> for obtaining their comments.		Deptt. of Bio-

023|| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to refer the case to Technology for obtaining their comments.||Deptt. of Bio-|

Case No.	Case No.	26 / NC/3/MEET/Aug/202526/7	26 / NC/3/MEET/Aug/202526/7	26 / NC/3/MEET/Aug/202526/7	26 / NC/3/MEET/Aug/202526/7	26 / NC/3/MEET/Aug/202526/7
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number		HQRNORM APPLY 00005504AM24
RA File Number		34AX04000414 AM24
Licence No and<br>Date		3411004086/08/09/2023
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 item in meeting No.NC/3/MEET/Apr/202526/2 dated 08/05/2025 against advance authorization No.<br>3411002729 dated 02/09/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given<br>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>Nadolol USP<br>20.4 mg.<br>2<br>Povidone K-30<br>4.14 mg.<br>3<br>Corn Starch (5%)<br>31.91 mg.<br>Nadolol Tablets USP 20 mg<br>1 Number
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Nadolol Tablets USP 20 mg		1 Number	1	Nadolol USP	20.4 mg.
				2	Povidone K-30	4.14 mg.
				3	Corn Starch (5%)	31.91 mg.

Product**||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Nadolol Tablets USP 20 mg||1 Number|1|Nadolol USP|20.4 mg.| |||||2|Povidone K-30|4.14 mg.| |||||3|Corn Starch (5%)|31.91 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

		4	Microcrystalline cellulose (Avicel PH<br>101)	50.0 mg.
		5	Citric acid monohydrate (Powder<br>Emprove)	5.75 mg.
		6	Magnesium stearate	1.75 mg.
Nadolol Tablets USP 40 mg	1 Number	7	Nadolol USP	40.8 mg.
		8	Povidone K-30	7.14 mg.
		9	Corn Starch (5%)	75.0 mg.

onohydrate (Powder Emprove)|5.75 mg.| ||||6|Magnesium stearate|1.75 mg.| ||Nadolol Tablets USP 40 mg|1 Number|7|Nadolol USP|40.8 mg.| ||||8|Povidone K-30|7.14 mg.| ||||9|Corn Starch (5%)|75.0 mg.| ||||10|Microcrystalline cellulose (Avicel PH 101)|91.0 mg.| ||||11|Citric acid monohydrate (Powder Emprove)|11.50 mg.| ||||12|Magnesium stearate|3.50 mg.| ||Nadolol Tablets USP 80 mg|1 Number|13|Nadolol USP|81.60 mg.| ||||14|Povidone K-30|12.00 mg.| ||||15|Corn Starch (5%)|150.0 mg.| ||||16|Microcrystalline cellulose (Avicel PH 101)|185.0 mg.| ||||17|Citric acid monohydrate (Powder Emprove)|23.00 mg.| ||||18|Magnesium stearate|7.00 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

Case No.	27 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	WEXFORD LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00005719AM24
RA File Number	07AX04000904 AM24
Licence No and<br>Date	0711009215/15/09/2023
Norms Committee Decision:<br>The committee considered the request of the firm for the fixation of ad-hoc norms and as per the advice of the TE, it<br>was decided to ask the firm to amend the aurhorisation as under:-<br>Get the export quantity converted into number of packs from kilograms for each export item in the<br>Authorisation.

TE, it was decided to ask the firm to amend the aurhorisation as under:- Get the export quantity converted into number of packs from kilograms for each export item in the Authorisation.||

Case No.	28 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00005822AM24
RA File Number	03AX04002768 AM24
Licence No and<br>Date	0311027333/22/09/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Hearing<br> before Norms Committee with sampel of export and import items such as import item (i)<br>Infusion, (ii) BOP Injection, (iii) SSC Infusion and (iv) SSC Injection.		Personal<br>BOP

Case No.	29 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

r|NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

and Date
HQ File Number	HQRNORM APPLY 00005845AM24
RA File Number	05AX04001599 AM24
Licence No and<br>Date	0511021137/25/09/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal<br>Hearing<br>before Norms Committee to explain its case along with copy of Certificate of Analysis (CoA) for<br>import and export item.

Case No.	30 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00005955AM24
RA File Number	34AX04000512 AM24
Licence No and<br>Date	3411004188/29/09/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

|RA File Number|34AX04000512 AM24| |Licence No and Date|3411004188/29/09/2023| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	31 / NC/3/MEET/Aug/202526/7
Case Status	Case Approved
Party Name	MEGHMANI DYES AND INTERMEDIATES LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00005963AM24
RA File Number	08AX04001166 AM24
Licence No and<br>Date	0811009505/02/10/2023
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<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
DASDA (4,4-Diaminostilben-2,2-disulfonic	<br>1 kg.	1	DNS (4,4-Dinitrostilben-2,2-	1.22 kg.
acid)			disulfonic acid)

y.**|Sl. No.|Import Items|Qty. allowed.| |---|---|---|---|---| |DASDA (4,4-Diaminostilben-2,2-disulfonic| 1 kg.|1|DNS (4,4-Dinitrostilben-2,2-|1.22 kg.| |acid)|||disulfonic acid)||

Case No.	32 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	USV PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM REVIW00008930AM24
RA File Number	03AX04003005 AM24
Licence No and<br>Date	0311027533/03/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Hearing<br>before Norms Committee to explain its case along with relevant information / documents<br>firm.		Personal<br>from the

Case No.	33 / NC/3/MEET/Aug/202526/7
Case Status	Case Approved
Party Name	PUNISKA HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00006000AM24
RA File Number	08AX04001244 AM24
Licence No and<br>Date	0811009510/03/10/2023
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<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

as applied by the firm, whichever is less:-||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
Isoproterenol	Hydrochloride	<br>1 Number	1	Isoproterenol Hydrochloride	1.10 mg.
Injection USP, 0.2	mg / ml (5ml)
Isoproterenol	Hydrochloride	<br>1 Number	2	Isoproterenol Hydrochloride	0.22 mg.
Injection, USP 0.2	mg / ml

Case No.	34 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	CHEMIKER PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00006178AM24
RA File Number	50AX04000062 AM24
Licence No and<br>Date	5011001072/11/10/2023
Norms Committee Decision:
The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE, it was
decided to call for following information/documents from the firm:-
Step wise complete and balanced chemical reaction with molecular weight and percentage yield on<br>1.
molar basis.
Recovery of Solvent at each step.<br>2.

Case No.	35 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	RUMIT LIFE CARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00006397AM24

ug/202526/7| |---|---| |Case Status|Case Deferred| |Party Name|RUMIT LIFE CARE| |Meeting Number and Date|NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025| |HQ File Number|HQRNORM APPLY 00006397AM24|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

RA File Number	03AX04002697 AM24
Licence No and<br>Date	0311028091/20/10/2023
Norms Committee Decision:
The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE, it was
decided to call for following information/documents from the firm:-
Complete and Balanced chemical reactions with molecular weight and percentage yield on molar basis.

Case No.	36 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	RALLIS INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00006775AM24
RA File Number	03AX04003377 AM24
Licence No and<br>Date	0311028623/09/11/2023
Norms Committee Decision:
The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE, it was
decided to call for following information/documents from the firm:-
Balanced chemical reaction with stichometric balance on molar basis.

d-hoc norms and as per the advice of the TE, it was|| |decided to call for following information/documents from the firm:-|| |Balanced chemical reaction with stichometric balance on molar basis.||

Case No.<br>37 / NC/3/MEET/Aug/202526/7
Case Status<br>Case Approved
Party Name<br>ACUTAAS CHEMICALS LIMITED
Meeting Number and<br>Date<br>NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number<br>HQRNORM APPLY 00006801AM24
RA File Number<br>52AX04000234 AM24
Licence No and Date<br>5211006397/10/11/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import item in meeting No.NC/3/MEET/Mar/202425/19 dated 27/03/2025 against advance
authorization No. 5211007960 dated 24/04/2024, 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:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
4-{1-[(2S)-2-Aminopropyl]-1-H-Pyrazole-<br>3-yl}-2- Chlorobenzonitrile	1 kg.	1	Tert-Butyl (1S)-2-hydroxy-1-<br>methylethyl) carbamate	0.826 kg.
		2	Diisopropyl azodicarboxylate	1.034 kg.
		3	TRIPHENYLPHOSPHINE	1.237 kg.
		4	2-chloro-4-(1H-pyrazol-3-yl)<br>benzonitrile	0.963 kg.

(1S)-2-hydroxy-1- methylethyl) carbamate|0.826 kg.| |||2|Diisopropyl azodicarboxylate|1.034 kg.| |||3|TRIPHENYLPHOSPHINE|1.237 kg.| |||4|2-chloro-4-(1H-pyrazol-3-yl) benzonitrile|0.963 kg.|

Case No.	Case No.	38 / NC/3/MEET/Aug/202526/7	38 / NC/3/MEET/Aug/202526/7	38 / NC/3/MEET/Aug/202526/7	38 / NC/3/MEET/Aug/202526/7	38 / NC/3/MEET/Aug/202526/7
Case Status		Case Approved
Party Name		MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number		HQRNORM APPLY 00006896AM24
RA File Number		08AX04001535 AM24
Licence No and<br>Date		0811009983/17/11/2023
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<br>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>Ceftriaxone for Injection USP 500 mg<br>1 Number Vial<br>1<br>Ceftriaxone Sodium<br>(Sterile IP/USP)<br>580 mg.<br>Ceftriaxone and Sulbactam for Injection 1.5<br>gm<br>1 Number Vial<br>2<br>Ceftriaxone Sodium<br>(Sterile IP/USP)<br>1.16 gm.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Ceftriaxone for Injection USP 500 mg		1 Number Vial	1	Ceftriaxone Sodium<br>(Sterile IP/USP)	580 mg.
	Ceftriaxone and Sulbactam for Injection 1.5<br>gm		1 Number Vial	2	Ceftriaxone Sodium<br>(Sterile IP/USP)	1.16 gm.

n USP 500 mg||1 Number Vial|1|Ceftriaxone Sodium (Sterile IP/USP)|580 mg.| ||Ceftriaxone and Sulbactam for Injection 1.5 gm||1 Number Vial|2|Ceftriaxone Sodium (Sterile IP/USP)|1.16 gm.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

Ceftriaxone for Injection USP	1	gm	1	Number Vial	3	Ceftriaxone Sodium	1.16 gm.
						(Sterile IP/USP)

Case No.	39 / NC/3/MEET/Aug/202526/7
Case Status	Case Withdrawn
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00007039AM24
RA File Number	07AX04001335 AM24
Licence No and<br>Date	0711009794/24/11/2023
Norms Committee Decision:
The Committee considered the case as per the agenda, and it has been observed that the firm has paid the
duty and interest and also closed the licence through the concerned RA. Therefore, it was decided toclose
the application of the firm.

d it has been observed that the firm has paid the|| |duty and interest and also closed the licence through the concerned RA. Therefore, it was decided toclose|| |the application of the firm.||

Case No.	40 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00007114AM24
RA File Number	07AX04001360 AM24
Licence No and<br>Date	0711009823/30/11/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advice of
the TE, it was decided to call for following information/documents from the firm:-
Stepwise complete and balanced chemical reactions, with molecular weight and percentage yield on<br>1.
molar basis.
Copy of Technical Literature in support of yields claimed.<br>2.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

Recovery of solvent at each step.

r>2.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

Recovery of solvent at each step.

Case No.	Case No.	41 / NC/3/MEET/Aug/202526/7	41 / NC/3/MEET/Aug/202526/7	41 / NC/3/MEET/Aug/202526/7	41 / NC/3/MEET/Aug/202526/7	41 / NC/3/MEET/Aug/202526/7
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number		HQRNORM APPLY 00007195AM24
RA File Number		34AX04000621 AM24
Licence No and<br>Date		3411004402/04/12/2023
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<br>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>Pirfenidone (API)<br>272.34 mg.<br>2<br>Microcrystalline Cellulose<br>(Avicel PH 101)<br>18.86 mg.<br>3<br>Croscarmellose sodium<br>(Ac-Di-Sol)<br>6.37 mg.<br>Pirfenidone tablets 267 mg<br>1 Number<br>4<br>Microcrystalline Cellulose<br>(Avicel PH 102)<br>6.37 mg.<br>5<br>Pirfenidone (API)<br>817.02 mg.<br>6<br>Microcrystalline Cellulose<br>(Avicel PH 101)<br>56.59 mg.<br>Pirfenidone tablets 801mg<br>1 Number
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

PI) 817.02 mg. 6 Microcrystalline Cellulose (Avicel PH 101) 56.59 mg. Pirfenidone tablets 801mg 1 Number||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Pirfenidone tablets 267 mg||1 Number|1|Pirfenidone (API)|272.34 mg.| |||||2|Microcrystalline Cellulose (Avicel PH 101)|18.86 mg.| |||||3|Croscarmellose sodium (Ac-Di-Sol)|6.37 mg.| |||||4|Microcrystalline Cellulose (Avicel PH 102)|6.37 mg.| ||Pirfenidone tablets 801mg||1 Number|5|Pirfenidone (API)|817.02 mg.| |||||6|Microcrystalline Cellulose (Avicel PH 101)|56.59 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

7<br>Croscarmellose sodium<br>(Ac-Di-Sol)<br>19.10 mg.<br>8<br>Microcrystalline Cellulose<br>(Avicel PH 102)<br>19.10 mg.<br>RA concerned may take further necessary action as per above decision of NC.			7	Croscarmellose sodium<br>(Ac-Di-Sol)	19.10 mg.
			8	Microcrystalline Cellulose<br>(Avicel PH 102)	19.10 mg.

further necessary action as per above decision of NC.			7	Croscarmellose sodium<br>(Ac-Di-Sol)	19.10 mg.
			8	Microcrystalline Cellulose<br>(Avicel PH 102)	19.10 mg.

Case No.	Case No.	42 / NC/3/MEET/Aug/202526/7	42 / NC/3/MEET/Aug/202526/7	42 / NC/3/MEET/Aug/202526/7	42 / NC/3/MEET/Aug/202526/7	42 / NC/3/MEET/Aug/202526/7
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number		HQRNORM APPLY 00007192AM24
RA File Number		34AX04000671 AM24
Licence No and<br>Date		3411004398/04/12/2023
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 item in meeting No. NC/3/MEET/Apr/202526/2 dated 08/05/2025 against advance authorization<br>No.3411002729 dated 02/09/2022; it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>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>Nadolol USP<br>20.4 mg.<br>2<br>Povidone K-30<br>4.14 mg.<br>3<br>Corn Starch (5%)<br>31.91 mg.<br>4<br>Microcrystalline cellulose (Avicel PH 101)<br>50.0 mg.<br>5<br>Citric acid monohydrate (Powder Emprove)<br>5.75 mg.<br>Nadolol Tablets USP 20 mg<br>1 Number
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

cel PH 101) 50.0 mg. 5 Citric acid monohydrate (Powder Emprove) 5.75 mg. Nadolol Tablets USP 20 mg 1 Number||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Nadolol Tablets USP 20 mg||1 Number|1 |Nadolol USP|20.4 mg.| |||||2 |Povidone K-30|4.14 mg.| |||||3 |Corn Starch (5%)|31.91 mg.| |||||4 |Microcrystalline cellulose (Avicel PH 101)|50.0 mg.| |||||5 |Citric acid monohydrate (Powder Emprove)|5.75 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

		6	Magnesium stearate	1.75 mg.
Nadolol Tablets USP 40 mg	1 Number	7	Nadolol USP	40.8 mg.
		8	Povidone K-30	7.14 mg.
		9	Corn Starch (5%)	75.0 mg.

		6	Magnesium stearate	1.75 mg.
Nadolol Tablets USP 40 mg	1 Number	7	Nadolol USP	40.8 mg.
		8	Povidone K-30	7.14 mg.
		9	Corn Starch (5%)	75.0 mg.
		10	Microcrystalline cellulose (Avicel PH 101)	91.0 mg.
		11	Citric acid monohydrate (Powder Emprove)	11.50 mg.
		12	Magnesium stearate	3.50 mg.
Nadolol Tablets USP 80 mg	1 Number	13	Nadolol USP	81.60 mg.
		14	Povidone K-30	12.00 mg.
		15	Corn Starch (5%)	150.0 mg.
		16	Microcrystalline cellulose (Avicel PH 101)	185.0 mg.
		17	Citric acid monohydrate (Powder Emprove)	23.00 mg.
		18	Magnesium stearate	7.00 mg.

Case No.	43 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00007173AM24
RA File Number	05AX04002730 AM24

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

Licence No and 0511022438/04/12/2023 Date Norms Committee Decision:

The firm was called for Personal Hearing on 22.08.2025 through Video Conference, but the firm could not appear before Norms Committee. It was decided to grant one more opportunity to the firm for Personal Hearing with copy of Certificate of Analysis (CoA) for import and export item.

he firm could not appear before Norms Committee. It was decided to grant one more opportunity to the firm for Personal Hearing with copy of Certificate of Analysis (CoA) for import and export item.

Licence No and	Licence No and	Licence No and	0511022438/04/12/2023	0511022438/04/12/2023	0511022438/04/12/2023	0511022438/04/12/2023	0511022438/04/12/2023	0511022438/04/12/2023	0511022438/04/12/2023	0511022438/04/12/2023
Date
Norms Committee			Decision:
The firm was call<br>bf N			ed for Personal Hearing on 22.08.2025 through Video Conference, but the firm could not<br>Ci I didd i h fi fPl
appear eore o<br>Hi<br>ith			rms ommttee. t was ece to grant one more opportunty to te rm orersona<br>f Ctifit f Ali (CA) f it d t it
earng<br> w cop			y o ercae o nayss o or mpor an expor em.


Case No.			44 / NC/3/MEET/Aug/202526/7
Case Status			Case Approved
Party Name			FDC LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number			HQRNORM APPLY 00007220AM24
RA File Number			03AX04003769 AM24
Licence No and<br>Date			0311029140/06/12/2023
Norms Committee Decision:
The Committee			considered the case as per agenda and taking cue from the earlier decision for same export
<br>product/import			<br>item in meeting No.

|Norms Committee Decision:||||||||||| |The Committee|||considered the case as per agenda and taking cue from the earlier decision for same export|||||||| | product/import||| item in meeting No. NC/3/MEET/May/202526/26 dated 04/06/2025 against advance|||||||| | authorization No||| **.**0311037995 dated 16/10/2024, it was decided to fix ad-hoc norms under Para 4.07 of|||||||| |HBP Vol. I as pe||| r details given below or as applied by the firm, whichever is less:-|||||||| |||||||||||| |||||||||||| |||||||||||| |||Ex|port Product||Qty.|Sl. No.|Import Items||Qty. allowed.|| |||Sodium Cromoglicate Eye Drops 13.5 Ml ((Each 13.5 Ml Vial Contains Sodium Cromoglicate 0.270 gm Net Wt of Bulk 89.910 Kgs))||| 1 Number Vial|1|Sodium Cromoglicate||0.2754 gm. / 13.5 ml vial|| |||||||||||| |||Allercrom Eye Drops 10 M||l| 1 Number |2|S|odium Cromoglicate|0.204 g|m/10 ml vial| |||(Murine Hayfever Eye Drops 10 Ml And Cromostil Eye Drops 10 Ml)((Each 10 Ml Vial Contains Sodium Cromoglicate 0.2 gm Net Wt Of Bulk Drug Is||| Vial|||||| ||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

104.600 Kgs))

Vial|||||| ||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

104.600 Kgs))





Case No.		45 / NC/3/MEET/Aug/202526/7
Case Status		Case Approved

Party Name		S KANT HEALTHCARE LIMITED

Meeting Number<br>		NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
and Date
HQ File Number		HQRNORM APPLY 00007308AM24

RA File Number		03AX04004027 AM24
Licence No and<br>Date		0311029247/11/12/2023
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 Vol. I as per details given below or as applied by the firm, whichever is less:-<br>(A)

	Export P	roduct	Qty.	Sl. No.	Import Items	**Qty.

|HBP Vol. I as per details given below or as applied by the firm, whichever is less:- (A)|||||||||||| ||||||||||||| |||Export P|roduct|Qty.|||Sl. No.||Import Items||Qty. allowed.| ||||||||||||| ||||||||||||| |||Artemether 20|mg & Lumefantrine 120 mg| 1 Number Tablet|||1||Artemether||20.4 mg.| |||Tablets|||||||||| ||||||||||||| ||||||||2||Lumefantrine||122.4 mg.| ||||||||||||| ||||||||||||| |||Artemether 20 Dispersible Ta|mg & Lumefantrine 120 mg blets| 1 Number Tablet|||1||Artemether||20.4 mg.| ||||||||||||| ||||||||2||Lumefantrine||122.4 mg.| |||Artemether 40 mg & Lumefantrine 240 mg||1 Number Tablet|||1||Artemether||40.8 mg.| ||||||||2||Lumefantrine||244.8 mg.| ||||| |||||||| |||Artemether 80 mg & Lumefantrine 480 mg Tablets|| |1 Number Table|t|1||Artemether||81.6 mg.| ||||||||||||| |||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

2 Lumefantrine 489.6 mg.

(B)

)
Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Artemether	1 kg.	1	Artemisinin	1.04 kg.
		2	Sodium Borohydride	0.188 kg.
		3	Trimethyl Ortho Acetate 99% Min	0.50 kg.

(C)

)
Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Lumefantrine	1 kg.	1	2, 7 Dichloro A Dibutylamino Methyl 9<br>Hfluorene-4-Methanol DBA 99% Min	0.86896 kg.
		2	4 - Chlorobenzaldehyde	0.3476 kg.

Case No.	46 / NC/3/MEET/Aug/202526/7
Case Status	Case Approved
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00007347AM24
RA File Number	05AX04002833 AM24
Licence No and<br>Date	0511022620/12/12/2023
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<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

as applied by the firm, whichever is less:-||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Atorvastatin Calcium Tablets	<br>1 Number	1	Tert-Butyl[(4R,6R)-6-	6.259 mg.
USP 10 mg			(Cyano Methyl)-
			2,2dimethyl-1,3-Dioxan -
			4-Yl] Acetate (ATS8)
Atorvastatin Calcium Tablets	<br>1 Number	2	Tert-Butyl[(4R,6R)-6-	12.518 mg.
USP 20 mg			(Cyano Methyl)-
			2,2dimethyl-1,3-Dioxan -
			4-Yl] Acetate (ATS8)
Atorvastatin Calcium Tablets	<br>1 Number	3	Tert-Butyl[(4R,6R)-6-	25.036 mg.
USP 40 mg			(Cyano Methyl)-
			2,2dimethyl-1,3-Dioxan -
			4-Yl] Acetate (ATS8)
Atorvastatin Calcium Tablets	<br>1 Number	4	Tert-Butyl[(4R,6R)-6-	50.072 mg.
USP 80 mg			(Cyano Methyl)-
			2,2dimethyl-1,3-Dioxan -
			4-Yl] Acetate (ATS8)

Note: The Committee also recommended making new SION for above export products.

Case No.	47 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	METROCHEM API PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00007728AM24
RA File Number	09AX04000875 AM24
Licence No and<br>Date	0911006481/03/01/2024
Norms Committee Decision:
The firm was called for Personal Hearing on 22.08.2025 through Video Conference, but the firm could not

000875 AM24| |Licence No and Date|0911006481/03/01/2024| |Norms Committee Decision:|| |The firm was called for Personal Hearing on 22.08.2025 through Video Conference, but the firm could not||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

appear before Norms Committee. It was decided to grant one more opportunity to the firm for Personal Hearing with relevant documents/information.

Case No.	48 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	LOZEN PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00008339AM24
RA File Number	03AX04004941 AM24
Licence No and<br>Date	0311030679/05/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearing<br>before Norms Committee to explain its case along with following information / documents from the firm:<br>Technical justification.<br>I.<br>Shippng Bills for all the export items.<br>II.

ing before Norms Committee to explain its case along with following information / documents from the firm: Technical justification. I. Shippng Bills for all the export items. II.|||

Case No.	49 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	ELPPE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00008471AM24
RA File Number	03AX04004959 AM24
Licence No and<br>Date	0311031032/09/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Hearing<br>before Norms Committee to explain its case along with relevant information / documents<br>firm.		Personal<br>from the

Case No. 50 / NC/3/MEET/Aug/202526/7

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

m the|

Case No. 50 / NC/3/MEET/Aug/202526/7

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

Case Status	Case Rejected
Party Name	ORIENTAL AROMATICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00009358AM24
RA File Number	03AX04006024 AM24
Licence No and<br>Date	0311032573/27/03/2024
Norms Committee Decision:<br>Decision:The firm was initially granted an Advance Authorisation for the export product<br>_“AMBROZANE AB22005”_under Para 4.07 of the Handbook of Procedures (HBP). However, as<br>per Para 4.11(b) of the Foreign Trade Policy (FTP) 2023, products falling under the category of<br>perfume or perfumery compounds are ineligible for authorisation under Para 4.07 and are<br>mandatorily required to be processed under Para 4.06 of the HBP.<br>It was observed that the firm obtained the authorisation bymisdeclaring that its application<br>was covered under the provisions of Para 4.07, and has not furnished any technical<br>justification/information for the export product. Accordingly, the Committee found no merit in<br>fixing the norms and decided to reject the application.<br>The RA shall ensure that the said authorisation is regularised by recovery of applicable Customs<br>duty along with interest.

no merit in fixing the norms and decided to reject the application. The RA shall ensure that the said authorisation is regularised by recovery of applicable Customs duty along with interest. Further, the RA should also submit a report on how this authorisation was issued under Para 4.07 of HBP, to the Chairperson of the Norms Committee and to PC-4 Section, DGFT Headquarters. The RA concerned may take further necessary action in line with the above decision of the Committee.||

Case No.	51 / NC/3/MEET/Aug/202526/7
Case Status	Case Approved
Party Name	PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM REVIW00006319AM25
RA File Number	03AX04000127 AM25
Licence No and<br>Date	0311033003/15/04/2024
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of<br>information provided by the firm, it was decided to revise ad-hoc norms as under:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

Qty.	Sl. No.	Import Items	Qty. allowed.
1 Number	1	Vibegron<br>(Average Potency of 99.20%)	77.117 mg.
1 Number	2	Vibegron<br>(Average Potency of 99.20%)	77.117 mg.

|**Sl. No. **|Import Items|Qty. allowed.| |---|---|---|---| |1 Number|1|Vibegron (Average Potency of 99.20%)|77.117 mg.| |1 Number|2|Vibegron (Average Potency of 99.20%)|77.117 mg.|

Case No.	52 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	SYNERGIA SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00000333AM25
RA File Number	03AX04000023 AM25
Licence No and<br>Date	0311033222/19/04/2024
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal
Hearing<br>before Norms Committee to explain its case along with relevant information / documents from the
firm.

Case No.	53 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	APTRA SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00000952AM25
RA File Number	26AX04000006 AM25

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

Licence No and 2611001464/28/05/2024 Date Norms Committee Decision:

25 through Video Conference, but the firm could not appear before Norms Committee. It was decided to grant one more opportunity to the firm for Personal Hearing with relevant documents/information.

Case No.	54 / NC/3/MEET/Aug/202526/7
Case Status	Case Approved
Party Name	GULBRANDSEN INDUSTRIES LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00001000AM25
RA File Number	34AX04000145 AM25
Licence No and<br>Date	3411004994/29/05/2024
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<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.<br>Import Items<br>Qty. allowed.<br>1<br>Tin Ingots<br>0.0985 kg.<br>2<br>Stannic Chloride Anhydrous<br>0.212 kg.<br>3<br>Neodecanoic Acid<br>0.5717 kg.<br>Stannous Neodecanoate<br>(Commercially called as<br>TCAT-900, KOSMOS T-<br>900, TCAT 902 to 906, T-<br>CAT 990, CONFORT SO-<br>07 LE))<br>1 kg.<br>4<br>Di Propylene Glycol<br>0.2534 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

cessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

Case No.	55 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	AARTI PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00001028AM25
RA File Number	03AX04000079 AM25
Licence No and<br>Date	0311034279/31/05/2024
Norms Committee Decision:
The case is under consideration and TE was requested to expedite his comments.

C	ase No.		55 / NC/3/MEET/	Aug/202526/	7
C	ase Statu	s	Case Deferred
P	arty Nam	e	AARTI PHARMA	LABS LIMI	TED
<br>a	Meeting N<br>nd Date	umber	NC/ 3/ MEET/ Au	g/ 202526/ 7
					and 22/	08/2025
H	Q File N	umber	HQRNORM APP	LY 00001028	AM25
R	A File N	umber	03AX04000079 A	M25
L<br>D	icence N<br>ate	o and	0311034279/31/05	/2024
N<br>T	orms Co<br>he case	mmittee Decision:<br>is under consideration		and TE wa
					s reque	sted to expedite his comm	ents.



C	ase No.		56 / NC/3/MEET/A	ug/202526/7
C	ase Statu	s<br>	Case Rejected
P	arty Nam	e<br>	ETERNIS FINE C	HEMICALS	LIMITE	D
<br>a	Meeting N<br>nd Date	umber<br>	NC/ 3/ MEET/ Aug	/ 202526/ 7	and 22/0	8/2025
H	Q File N	umber<br>	HQRNORM APPL	Y 00001292	AM25
R	A File N	umber<br>	03AX04001135 A	M25
L<br>D	icence N<br>ate	o and<br>	0311034573/13/06/	2024

MEET/ Aug|/ 202526/ 7|and 22/0|8/2025|| |H|Q File N|umber |HQRNORM APPL|Y 00001292|AM25||| |R|A File N|umber |03AX04001135 A|M25|||| |L D|icence N ate|o and |0311034573/13/06/|2024|||| |N |orms Co The fir under P Foreign compou require In view clarify During credible categor Accord |mmittee Decision: m was initially granted ara 4.07 of the Handb Trade Policy (FTP) 2 nds are ineligible for d to be processed under of the above, the Com and establish that the pr the Personal Hearing, supporting evidence t y of perfume or perfum ingly, after due consid ||an Adva ook of Pr 023, produ authorisa Para 4.06 mittee pro oduct“Eta the firm o demonst ery compo eration of |nce A ocedu|uthorisation for the expo res (HBP). However as|rt product “Etambernis” per Para 4.11(b) of the| |||||| cts fal tion u of the vided mbern|, ling under the category o nder Para 4.07.

ion for the expo res (HBP). However as|rt product “Etambernis” per Para 4.11(b) of the| |||||| cts fal tion u of the vided mbern|, ling under the category o nder Para 4.07. Such pr HBP. the firm an opportunity f is”does not fall under the| f perfume or perfumery oducts are mandatorily or a Personal Hearing to said restricted category.| ||||||failed rate th und as|to provide a satisfactory at the product in question defined in Para 4.11(b) o|explanation or furnish does not fall under the f the FTP.| |||||| the fa | cts of the case, the sub | missions made, and the | ||relevan The re is here ofappli|t provisions of the FTP quest for fixation of no by rejected and the R cable Customs duty an||and HBP, rms unde A shall en d interest.|the Co r Para sure th Furthe|mmittee has decided as u 4.07 of the HBP for the at the authorisation is r r, the RA should also sub|nder: product“Etambernis” egularized by payment mit a report on how this|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

authorisation was issued under Para 4.07 of HBP, to the Chairperson of the Norms Committee and to PC-4 Section, DGFT Headquarters. The RA concerned may take further necessary action in line with the above decision of the Committee.

4.07 of HBP, to the Chairperson of the Norms Committee and to PC-4 Section, DGFT Headquarters. The RA concerned may take further necessary action in line with the above decision of the Committee.

Case No.	57 / NC/3/MEET/Aug/202526/7
Case Status	Case Approved
Party Name	ACUTAAS CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00001316AM25
RA File Number	52AX04000061 AM25
Licence No and<br>Date	5211008490/13/06/2024
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of<br>information provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Hydrazine Hydrate 64% (RM for<br>mfg of Semicarbazide HCL for<br>further mfg of TPO)<br>2.14 kg.<br>2<br>2-Chloro Pyridine<br>1.14 kg.<br>1,2,4 - TRIAZOLO (4,3-a) PYRIDIN -<br>3 (2H) - ONE - 98% MIN (TPO)<br>1 kg.<br>3<br>Ethylene Glycol Monoethyl<br>Ether/2-Ethoxy Ethanol<br>1.20 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 58 / NC/3/MEET/Aug/202526/7

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

NC.||

Case No. 58 / NC/3/MEET/Aug/202526/7

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

C	ase Statu	s	Case Rejected
P	arty Nam	e	ETERNIS FINE C	HEMICALS	LIMITE	D
<br>a	Meeting N<br>nd Date	umber	NC/ 3/ MEET/ Aug	/ 202526/ 7	and 22/0	8/2025

H	Q File N	umber	HQRNORM APPL	Y 00001293	AM25
R	A File N	umber	03AX04001186 A	M25
L<br>D	icence N<br>ate	o and	0311034574/13/06/	2024
N<br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br>R	orms Co<br>The fir<br>(4-Isop<br>Howev<br>categor<br>Such pr<br>In view<br>clarify<br>not fall<br>During<br>credible<br>categor	mmittee Decision:<br>m was initially granted<br>ropyl Cyclohexyl Meth<br>er, as per Para 4.11(b) o<br>y of perfume or perfu<br>oducts are mandatorily<br>of the above, the Com<br>and establish that the pr<br>under the said restricte<br>the Personal Hearing,<br>supporting evidence t<br>y of perfume or perfum		an Advan<br>anol)” un<br>f the Fore<br>mery comp<br>required t<br>mittee pro<br>oduct “M<br>d category.<br>the firm<br>o demonst<br>ery compo			“

supporting evidence t y of perfume or perfum||an Advan anol)” un f the Fore mery comp required t mittee pro oduct “M d category. the firm o demonst ery compo|||“| ||||||e Aut der Pa ign Tr ounds o be pr vided|orisation for the export p ra 4.07 of the Handboo ade Policy (FTP) 2023, p are ineligible for author ocessed under Para 4.06 o the firm an opportunity f|roduct MENTHANOL k of Procedures (HBP). roducts falling under the isation under Para 4.07. f the HBP. or a Personal Hearing to| |||||| ENTH | ANOL (4-Isopropyl Cycl | ohexyl Methanol)” does | ||||||failed rate th und as|to provide a satisfactory at the product in question defined in Para 4.11(b) o|explanation or furnish does not fall under the f the FTP.| || Accord relevan The req (4-Isop authori should Chairpe concern A conc| ingly, after due consid t provisions of the FTP uest for fixation of no ropyl Cyclohexyl Met sation is regularized by also submit a report on rson of the Norms C ed may take further nec erned may take further|| eration of and HBP, rms under hanol)” is payment o how this ommittee essary act necessary| the fa the Co Para 4 here | cts of the case, the sub mmittee has decided as u .07 of the HBP for the p by rejected and the RA | missions made, and the nder: roduct “MENTHANOL shall ensure that the |

r>cts of the case, the sub mmittee has decided as u .07 of the HBP for the p by rejected and the RA | missions made, and the nder: roduct “MENTHANOL shall ensure that the | ||||||f appl authori and t ion in action|cable Customs duty and sation was issued under P o PC-4 Section, DGFT line with the above decisi as per above decision of|nterest. Further, the RA ara 4.07 of HBP, to the Headquarters. The RA on of the Committee. NC.| ||||||||| |C|ase No.||59 / NC/3/MEET/A|ug/202526/7|||| |C|ase Statu|s|Case Approved||||| |P|arty Nam|e|GULBRANDSEN|INDUSTRIE|||| ||||||S LLP||| | a|Meeting N nd Date|umber|NC/ 3/ MEET/ Aug|/ 202526/ 7|and 22/0|8/2025|| |H|Q File N|umber|HQRNORM APPL|Y 00001492|AM25||| |RA File Number|||34AX04000146 AM25|||||

Case No.	59 / NC/3/MEET/Aug/202526/7
Case Status	Case Approved
Party Name	GULBRANDSEN INDUSTRIES LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00001492AM25
RA File Number	34AX04000146 AM25

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

Licence No and 3411005088/21/06/2024 Date 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:-

ion:

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.
Stannous Octoate<br>(Commercially called as TCAT 110,<br>NIAX<br>Stannous<br>Octoate,<br>NIAX<br>Catalyst<br>Stannous<br>Octoate,<br>CONFORT SO-07, KOSMOS T9))	<br> <br> <br>1 kg.	1	Tin Ingots	0.150 kg.
		2	Stannic Chloride Anhydrous	0.3248 kg.
		3	2-Ethyl hexanoic Acid	0.7266 kg.

Case No.	60 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	PANACEA BIOTEC PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00001565AM25
RA File Number	05AX04000957 AM25
Licence No and<br>Date	0511026325/26/06/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	61 / NC/3/MEET/Aug/202526/7
Case Status	Case Approved
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

e|NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

H	Q File N	umber	HQRNORM APPL	Y 00001606	AM25	AM25
R	A File N	umber	03AX04001454 A	M25
L<br>D	icence N<br>ate	o and	0311034979/27/06/	2024

N<br> <br> <br> <br> <br>R	orms Co<br>The Co<br>product/<br>authoriz	mmittee Decision:<br>mmittee considered the ca<br>import item in meetin<br>ation No.0311017254 dat		se as per ag<br>g No.NC/3<br>ed 16/08/2	d		d tki f th li			dii f t
					ena a<br>/MEET<br>022 , it		ang cue rom e ear<br>/Apr/202526/2 dated 08/<br>was decided to fix ad-hoc			r ecson or same expor<br>05/2025 against advance<br>norms under Para 4.07 of
	HBP Vo<br> <br>Olopa<br>Furoa<br>(RYA<br>Mom<br>Olop<br>Mom<br>/ 25<br>conte<br>Mon<br>Olop<br>Mom<br>/ 25<br>conte<br>Mon	l. I as per details given be		low or as a	pplied		by the firm, whichever is les			s:-
		Export Product				Qty.		Sl. No.	Import Ite	ms	**Qty.

p Mom / 25 conte Mon||l. I as per details given be||low or as a|pplied||by the firm, whichever is les|||s:-|| ||||Export Product||||Qty.||**Sl. No. **|Import Ite|ms|Qty. allowed.| |||Olopa Furoa (RYA Mom|tadine Hydrochloride and te Nasal Spray 600 m LTRIS) 240 MD (Net etasone Furoate Monohydrat||Mometaso cg / 25m content e – 600 gm.)|||||||| |||||||ne cg of| 1000 Num|00 bers|1|Mometason Monohydrat|e Furoate e|612 gm.| |||Olop Mom / 25 conte Mon|atadine Hydrochlor etasone Furoate Nasal S mcg (RYALTRIS) 12 nt of Mometason ohydrate – 300 gm.)||ide a pray 600 m 0 MD (N e Furoa|nd | 1000 N|00 br|2|Mometason Monohydrat|e Furoate e|306 gm.| |||||||g et te| u|es||||| |||Olop Mom / 25 conte Mon|atadine Hydrochlor etasone Furoate Nasal S mcg (RYALTRIS) 5 nt of Mometason ohydrate – 140 gm.)||ide a pray 600 m 6 MD (N e Furoa|nd | 1000 N|00 br|3|Mometason Monohydrat|e Furoate e|142.8 gm.| |||||||g et te| u|es||||| |||||||||||||| |||||||||||||| ||A conc||erned may take further ne||cessary acti|on as p||er above decision of NC.||||| |||||||||||||| |C|ase No.|||62 / NC/3/MEET/A|ug/202526/7|||||||| |C|ase Statu||s|Case Approved||||||||| |P|arty Nam||e|ACUTAAS CHEM|ICALS LIM|ITED||||||| | a|Meeting N nd Date||umber|NC/ 3/ MEET/ Aug|/ 202526/ 7|and 22/0||8/2025|||||

ET/A|ug/202526/7|||||||| |C|ase Statu||s|Case Approved||||||||| |P|arty Nam||e|ACUTAAS CHEM|ICALS LIM|ITED||||||| | a|Meeting N nd Date||umber|NC/ 3/ MEET/ Aug|/ 202526/ 7|and 22/0||8/2025||||| |H|Q File N||umber|HQRNORM APPL|Y 00001683|AM25||||||| ||||||||||||||

Case No.	62 / NC/3/MEET/Aug/202526/7
Case Status	Case Approved
Party Name	ACUTAAS CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00001683AM25

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

RA File Number

52AX04000062 AM25

Licence No and Date

5211008717/02/07/2024

Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Mar/202425/19 dated 27/03/2025 against advance authorization No.5211007960 dated 24/04/2024 , 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. 1 Tert-Butyl (1S)-2-hydroxy-1- methylethyl) carbamate 0.826 kg. 2 Diisopropyl azodicarboxylate 1.034 kg. 4-{1- [(2S)-2-Aminopropyl]-1-H- Pyrazole-3-yl}-2- Chlorobenzonitrile 1 kg. 3 Triphenylphosphine 1.237 kg. RA concerned may take further necessary action as per above decision of NC.

[(2S)-2-Aminopropyl]-1-H- Pyrazole-3-yl}-2- Chlorobenzonitrile 1 kg. 3 Triphenylphosphine 1.237 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	63 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	JUBILANT GENERICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00001713AM25
RA File Number	05AX04001073 AM25
Licence No and<br>Date	0511026456/03/07/2024
Norms Committee Decision:<br>The committee decided to defer the case for next meeting.

Case No. 64 / NC/3/MEET/Aug/202526/7

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

Case Status<br>Case Approved
Party Name<br>AVIK PHARMACEUTICAL LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number<br>HQRNORM APPLY 00001694AM25
RA File Number<br>52AX04000072 AM25
Licence No and<br>Date<br>5211008732/03/07/2024
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:-
Export Product	Qty.	Sl. No.	Import Items	**Qty.

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.|| |Prednisolone Sodium Metasulfobenzoate (PSB)|1 kg.|1|Prednisolone|1.00 kg.|| |RA concerned may take further necessary action as per above decision of NC.||||||

Case No.	65 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00001763AM25
RA File Number	31AX04000098 AM25
Licence No and<br>Date	3111003647/05/07/2024
Norms Committee Decision:
The case is under consideration and TE was requested to expedite his comments.

Case No.	66 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00001769AM25
RA File Number	07AX04000561 AM25
Licence No and<br>Date	0711011739/05/07/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Hearing<br>before Norms Committee to explain its case along with relevant information / documents<br>firm.		Personal<br>from the

as per agenda and it was decided to call the firm for attending Hearing before Norms Committee to explain its case along with relevant information / documents firm.||Personal from the|

Case No.	67 / NC/3/MEET/Aug/202526/7
Case Status	Case Approved
Party Name	TIDE INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00001846AM25
RA File Number	34AX04000273 AM25
Licence No and<br>Date	3411005128/09/07/2024
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<br>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>Aldehyde C10<br>(Capric Aldehyde)<br>1 kg.<br>1<br>Fatty Alcohol C10<br>(98% Purity)<br>1.40 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	68 / NC/3/MEET/Aug/202526/7
Case Status	Case Approved

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

2526/7| |---|---| |Case Status|Case Approved|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

Party Name<br>INNOVARE LABS PRIVATE LIMITED	Party Name<br>INNOVARE LABS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number<br>HQRNORM APPLY 00001870AM25
RA File Number<br>09AX04000225 AM25
Licence No and<br>Date<br>0911007569/10/07/2024
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:-
Export Product<br>Qty.	Sl. No.	Import Items	Qty. allowed.
7-chloro-5-(2-chlorophenyl)-1,3-dihydro-<br>1 kg.	1	(2-amino-5-chlorophenyl) (2-	1.15 kg.
2H-1,4-benzodiazepin-2-one 4-oxide or		chlorophenyl) methanone
Delorazepam-4-oxide (LNO)
RA concerned may take further necessary action as per above decision of NC.

(2-|1.15 kg.|| |2H-1,4-benzodiazepin-2-one 4-oxide or||chlorophenyl) methanone||| |Delorazepam-4-oxide (LNO)||||| |RA concerned may take further necessary action as per above decision of NC.|||||

Case No.	Case No.	69 / NC/3/MEET/Aug/202526/7
Case Status		Case Approved
Party Name		FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ	File Number	HQRNORM APPLY 00001942AM25
RA File Number		03AX04001857 AM25
Licence No and<br>Date		0311035506/15/07/2024
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:-
	Export Product<br>Qty.		Sl. No.	Import Items	Qty. allowed.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

Aminowel	5% Infusion	250ml	155000	1	Glycine EP	142.405	kg.
			Numbers

25 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

Aminowel	5% Infusion	250ml	155000	1	Glycine EP	142.405	kg.
			Numbers

Case No.	70 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00001961AM25
RA File Number	03AX04001867 AM25
Licence No and<br>Date	0311035566/16/07/2024
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal
Hearing<br>before Norms Committee to explain its case along with relevant information / documents from the
firm.

Case No.	71 / NC/3/MEET/Aug/202526/7
Case Status	Case Approved
Party Name	UMEDICA LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00001953AM25
RA File Number	03AX04001667 AM25
Licence No and<br>Date	0311035539/16/07/2024
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import	item in meeting No.NC/3/MEET/Mar/202425/19 dated 27/03/2025 against advance
authorization No.0311036494 dated 21/08/2024 , 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:-

ce| |authorization No.0311036494 dated 21/08/2024 , 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:-||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Clotrimazole USP / BP / EP / IH	1 kg.	1	Ortho Chloro Phenyl<br>Diphenyl Chloromethane	1.03 kg.
		2	Imidazole	0.310 kg.

Note: The Committee also recommended making new SION for above export product.

Case No.	72 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00001994AM25
RA File Number	03AX04001885 AM25
Licence No and<br>Date	0311035597/18/07/2024
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 with sampel of export and import items such as import item (i)<br>BOP Infusion, (ii) BOP Injection, (iii) SSC Infusion and (iv) SSC Injection.

Case No.	73 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	STYRAX LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00002025AM25

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

RA File Number	09AX04000240 AM25
Licence No and<br>Date	0911007615/19/07/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	74 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	STYRAX LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00002026AM25
RA File Number	09AX04000239 AM25
Licence No and<br>Date	0911007616/19/07/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

|RA File Number|09AX04000239 AM25| |Licence No and Date|0911007616/19/07/2024| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	75 / NC/3/MEET/Aug/202526/7
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00002051AM25
RA File Number	34AX04000849 AM24
Licence No and<br>Date	3411005190/22/07/2024
Norms Committee Decision:<br>The Committee consider the case as per agenda and it has been observed that description of import and<br>export items do not match with Drug Manufacturing Licence (DML), Therefore, it was decided to call the<br>firm forPersonal Hearing<br> before Norms Committee to explain its case alongwith relevant documents.

Case No. 76 / NC/3/MEET/Aug/202526/7

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

nts.||

Case No. 76 / NC/3/MEET/Aug/202526/7

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

Case Status	Case Approved
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00002058AM25
RA File Number	08AX04000652 AM25
Licence No and Date	0811012185/22/07/2024
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<br>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>Phloroglucinol Dihydrate BP<br>44.00 mg.<br>Phloroglucinol and<br>Trimethylphloroglucinol Injection<br>40 mg + 0.04 mg /4ml<br>1 Number<br>2<br>Trimethyl Phloroglucinol BP<br>0.044 mg<br>RA concerned may take further necessary action as per above decision of NC.

imethylphloroglucinol Injection 40 mg + 0.04 mg /4ml 1 Number 2 Trimethyl Phloroglucinol BP 0.044 mg RA concerned may take further necessary action as per above decision of NC.||

Case No.	77 / NC/3/MEET/Aug/202526/7
Case Status	Case Approved
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00002060AM25
RA File Number	05AX04001134 AM25
Licence No and<br>Date	0511026794/22/07/2024
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 item in meeting No.NC/3/MEET/Jun/202526/5 dated 30/06/2025 against advance<br>authorization No.0511029366 dated 03/12/2024 , 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:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Cefepime For Injection	1 kg.	1	Cefepime HCL (Non Sterile)	0.655 kg.

Note: The Committee also recommended making new SION for above export products.

*Qty. allowed.**| |---|---|---|---|---| |Cefepime For Injection|1 kg.|1|Cefepime HCL (Non Sterile)|0.655 kg.|

Note: The Committee also recommended making new SION for above export products.

Case No.	Case No.	78 / NC/3/MEET/Aug/202526/7	78 / NC/3/MEET/Aug/202526/7	78 / NC/3/MEET/Aug/202526/7	78 / NC/3/MEET/Aug/202526/7	78 / NC/3/MEET/Aug/202526/7	78 / NC/3/MEET/Aug/202526/7
Case Status		Case Approved
Party Name		BLUE JET HEALTHCARE LIMITED
Meeting Number
<br>and Date		NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number		HQRNORM APPLY 00002066AM25
RA File Number		03AX04001974 AM25
Licence No and<br>Date		0311035722/23/07/2024
Norms Committee		Decision:

The Committee<br>product/import		considered the case as per agenda and taking cue from the earlier decision for sa<br>item in meeting No.NC/3/MEET/Jan/202425/16 dated 27/01/2025 against					me export<br>advance
authorization No.0311021934 dated 06/03/2023, 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. allowed.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed.|||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.|| ||||||||| ||1,15 diethyl 2,2,14,14-tetramethyl-8- oxopentadecanedioate||1 kg.|1|Tetrahydrofuran|1.125 kg.|| |||||2|n-Heptane|1.787 kg.|| ||||||||| ||||||||| |||||3|Ethyl Isobutyrate|0.686 kg.|| ||||||||| ||||||||| |||||4|1 Bromo-5-chloropentane|1.10 kg.|| ||||||||| |||||||||

Case No.	78 / NC/3/MEET/Aug/202526/7	78 / NC/3/MEET/Aug/202526/7
Case Status	Case Approved
Party Name	BLUE JET HEALTHCARE LIMITED
Meeting Number
<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00002066AM25
RA File Number	03AX04001974 AM25
Licence No and<br>Date	0311035722/23/07/2024
Norms Committee	Decision:

The Committee<br>product/import	considered the case as per agenda and taking cue from the earlier decision for sa<br>item in meeting No.NC/3/MEET/Jan/202425/16 dated 27/01/2025 against	me export<br>advance
authorization No.0311021934 dated 06/03/2023, 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 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.|||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.|| ||||||||| ||1,15 diethyl 2,2,14,14-tetramethyl-8- oxopentadecanedioate||1 kg.|1|Tetrahydrofuran|1.125 kg.|| |||||2|n-Heptane|1.787 kg.|| ||||||||| ||||||||| |||||3|Ethyl Isobutyrate|0.686 kg.|| ||||||||| ||||||||| |||||4|1 Bromo-5-chloropentane|1.10 kg.|| ||||||||| |||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

5<br>N, N Dimethylacetamide<br>1.675 kg.<br>6<br>Sodium t-pentoxide<br>0.567 kg.<br>7<br>Tosmic<br>0.512 kg.<br>RA concerned may take further necessary action as per above decision of NC.			5	N, N Dimethylacetamide	1.675 kg.
			6	Sodium t-pentoxide	0.567 kg.
			7	Tosmic	0.512 kg.

oncerned may take further necessary action as per above decision of NC.			5	N, N Dimethylacetamide	1.675 kg.
			6	Sodium t-pentoxide	0.567 kg.
			7	Tosmic	0.512 kg.

Case No.	79 / NC/3/MEET/Aug/202526/7
Case Status	Case Rejected
Party Name	ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00002069AM25
RA File Number	03AX04001934 AM25
Licence No and<br>Date	0311035731/23/07/2024
Norms Committee Decision:<br>The firm was initially granted an Advance Authorisation for the export product_“_C-8 Aldehyde”<br>under Para 4.07 of the Handbook of Procedures (HBP). However, as per Para 4.11(b) of the<br>Foreign Trade Policy (FTP) 2023, products falling under the category of perfume or perfumery<br>compounds are ineligible for authorisation under Para 4.07 and are mandatorily required to be<br>processed under Para 4.06 of the HBP.<br>It was observed that the firm obtained the authorisation bymisdeclaring that its application was<br>covered under the provisions of Para 4.07, and has not furnished any technical<br>justification/information for the export product. Accordingly, the Committee found no merit in<br>fixing the norms and decided to reject the application.<br>The RA shall ensure that the said authorisation is regularised by recovery of applicable Customs<br>duty along with interest.

no merit in fixing the norms and decided to reject the application. The RA shall ensure that the said authorisation is regularised by recovery of applicable Customs duty along with interest. Further, the RA should also submit a report on how this authorisation was issued under Para 4.07 of HBP, to the Chairperson of the Norms Committee and to PC-4 Section, DGFT Headquarters. The RA concerned may take further necessary action in line with the above decision of the Committee. RA concerned may take further necessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

Case No.	80 / NC/3/MEET/Aug/202526/7
Case Status	Case Approved
Party Name	WEST BENGAL CHEMICAL INDUSTRIES LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00002099AM25
RA File Number	02AX04000242 AM25
Licence No and<br>Date	0211006960/23/07/2024
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<br>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.

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. Calcium Citrate USP 1 kg. 1 Citric Acid 0.8115 kg. **Note:**The Committee also recommended making new SION for above export products. RA concerned may take further necessary action as per above decision of NC.||

Case No.	81 / NC/3/MEET/Aug/202526/7
Case Status	Case Approved
Party Name	MEONE HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00002100AM25
RA File Number	04AX04000340 AM25
Licence No and<br>Date	0411007845/23/07/2024
Norms Committee Decision:

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Mar/202425/18 dated 17/03/2025 against advance authorization No.0411006454 dated 22/11/2023, 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:-

inst advance authorization No.0411006454 dated 22/11/2023, 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.
Foscarnet Sodium Injection 250 ml.	<br>1 Number	1	Foscarnet	Sodium	<br>API	<br>6.30 gm.
(24 mg / ml which contain 88.33%			(Foscarnet		Sodium
strength of import item			Hexahydrate	EP 8.0)

Case No.<br>82 / NC/3/MEET/Aug/202526/7
Case Status<br>Case Approved
Party Name<br>TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number<br>HQRNORM APPLY 00002125AM25
RA File Number<br>08AX04000637 AM25
Licence No and<br>Date<br>0811012200/24/07/2024
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import item in meeting No.NC/3/MEET/May/202526/3		dated 04/06/2025 against advance
authorization No.0811013116 dated 30/10/2024, 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.

|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.|| |Co-Careldopa Tablets 250 mg + 25 mg 1 Number|1|Levodopa BP|255.0 mg/Tablet|| |(Tidomet / Tidomet Forte, Levodopa 250||||| |mg +Carbidopa 25 mg Tablets) (Each||||| |uncoated tablet contains Levodopa BP|||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

250 mg

Case No.	83 / NC/3/MEET/Aug/202526/7
Case Status	Case Approved
Party Name	AMI LIFESCIENCES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00002191AM25
RA File Number	34AX04000348 AM25
Licence No and<br>Date	3411005225/29/07/2024
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<br>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>Fursultiamine Hydrochloride<br>1 kg.<br>1<br>Thiamine Hydrochloride<br>1.23 kg.<br>RAconcerned to verify that the item of export is necessarily for use in the pharmaceutical industry to<br>comply with the condition of Para 4.11 of FTP by checking the export order, etc., and accordingly may take<br>further necessary action as per the above decision of NC.

rmaceutical industry to comply with the condition of Para 4.11 of FTP by checking the export order, etc., and accordingly may take further necessary action as per the above decision of NC.||

Case No.	84 / NC/3/MEET/Aug/202526/7
Case Status	Case Approved
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202526/ 7 and 22/08/2025
HQ File Number	HQRNORM APPLY 00002205AM25

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00304919AM26

RA File Number

05AX04001339 AM25

Licence No and Date

0511026904/30/07/2024

Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/May/202526/3 dated 04/06/2025 against advance authorization No.0511028273 dated 14/10/2024, 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. 1 Tobramycin 6300 gm. Tobramycin and Dexamethasone Ophthalmic Suspension 5ml ((Each ml contains Tobramycin 3 mg.

oduct** Qty. Sl. No. Import Items Qty. allowed. 1 Tobramycin 6300 gm. Tobramycin and Dexamethasone Ophthalmic Suspension 5ml ((Each ml contains Tobramycin 3 mg. & Dexamethasone 1mg (Equivalent to 6000gm Tobramycin Bulk Drug and 2000 gm Dexamethasone Bulk Drug)) 400000 Numbers 2 Dexamethasone USP (Micronised ) 2100 gm. **Note:**The Committee also recommended making new SION for above export products. RA concerned may take further necessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Sep-2025 15:17:18 Reason: ramankumar@nic.in Location: DGFT(HQ)

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