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

MINUTES OF THE NORMS COMMITTEE- III

Meeting No - NC/3/MEET/Dec/202526/11 Meeting Date - 18/12/2025

Minutes of the Norms Committee–3 Meeting No.NC/3/MEET/Dec/202526/11 dated 18/12/2025 under the Chairmanship of Shri Rakesh Kumar, Addl. DGFT for considering the cases/issues under Duty Exemption Scheme (Chapter-4) of the Foreign Trade Policy, 2023 pertaining to Chemical and Allied products falling under Chapter 29 and 30.

    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 Raman Kumar, Deputy DGFT	DGFT (HQ)

    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.

Signature Not Verified Signature Not Verified Digitally Signed. Digitally signa, Name: RAMAN KUMAR( Deputy Name: RAMAN KUJAAR( Deputy DGFT ) DGFT Date: 16-Jan-2026 18:51:03 Date: )16-Jan-2 18:51:03 Reason: ramankumar@nic.in Reason: ramankumar@nic.in Location: DGFT(HQ) Location: DGFTTHQ)

This document has been digitally signed by Raman Kumar, Deputy DGFT,DGFT(HQ) on 16-Jan-2026.

8:51:03 Reason: ramankumar@nic.in Reason: ramankumar@nic.in Location: DGFT(HQ) Location: DGFTTHQ)

This document has been digitally signed by Raman Kumar, Deputy DGFT,DGFT(HQ) on 16-Jan-2026.

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    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.

Case No.	1 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000124AM26
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal<br>Hearing<br> before Norms Committee to explain its case along with following information / documents from<br>the firm:<br>Whether the export description is as per Drug Manufacturing Licence (DML)?<br>1.<br>Copy of such DML.<br>2.

to explain its case along with following information / documents from the firm: Whether the export description is as per Drug Manufacturing Licence (DML)? 1. Copy of such DML. 2.|||

Case No.	2 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000125AM26
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it has been observed by the Committee the Advance<br>Authorisation is 2009 and there is no import item is listed in Advance Authorisation, Therefore, it was<br>decided to call the firm for attendingPersonal Hearing<br> before Norms Committee to explain its case along<br>with relevant documents from the firm.

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

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ments from the firm.||

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Case No.	3 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00001052AM26
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The representative of the firm attended the Personal Hearing and presented the case. The Committee<br>considered the submissions made and, after due deliberation, advised the firm to furnish the net percentage<br>wastage from rolls to finished product, separately for the upper and lower sides.

Case No.	4 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	FINE ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00001277AM25
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the firm’s request for fixation of ad-hoc norms. However, it was observed that<br>the firm, vide its letter dated 10.12.2025, requested withdrawal of the application. Accordingly, the<br>Committee decided to close the firm’s application.

orms. However, it was observed that the firm, vide its letter dated 10.12.2025, requested withdrawal of the application. Accordingly, the Committee decided to close the firm’s application.||

Case No.	5 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	PUROGENE LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00006919AM25

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

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RA File Number	NA
Licence No and<br>Date	NA
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 Moleculare Weight.<br>1.
Percentage Yield on Molar basis for each step.<br>2.
Material balance for each step.<br>3.

Case No.	6 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	VIJAYASRI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	018305000961AM12
RA File Number	092404000478 AM12
Licence No and<br>Date	0910051240/13/02/2012
Norms Committee Decision:
The case is under consideration and TE was requested to expedite his comments.

12| |RA File Number|092404000478 AM12| |Licence No and Date|0910051240/13/02/2012| |Norms Committee Decision:|| |The case is under consideration and TE was requested to expedite his comments.||

Case No.	7 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	SWEMED DIAGNOSTICS
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	018305000077AM15
RA File Number	072404000426 AM14
Licence No and<br>Date	0710102252/20/02/2014
Norms Committee Decision:
The Committee considered the case as per the agenda and observed that the firm has still not furnished the
complete application along with the relevant documents. Accordingly, it was decided to grant one more
opportunity to the firm to submit the complete application. The concerned RA may also be requested to
forward the firm’s application.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

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uested to|| |forward the firm’s application.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Case No.	8 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	UNIJULES LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	018305000700AM15
RA File Number	039504000413 AM15
Licence No and<br>Date	0310787952/12/08/2014
Norms Committee Decision:<br>The Committee considered the case as per the agenda and noted that the firm has failed to furnish a reply to<br>the deficiency letter despite repeated reminders and adequate opportunities being provided. In the absence<br>of the required information and documents, the Committee decided to reject the case.

Case No.	9 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	BELOORBAYIR BIOTECH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM REVIW00007896AM24
RA File Number	072404000347 AM16
Licence No and<br>Date	0710109255/12/01/2016
Norms Committee Decision:<br>NC decided to defer the case.

Case No.	10 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	CIPLA LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM REVIW00000398AM26
RA File Number	039404000726 AM18
Licence No and Date	0310817755/13/12/2017

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Norms Committee Decision:

The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:-

|Norms Committee Decision: The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Ipratropium Bromide 4.00 mg. 4 63 mcl AEROSOL VALVES 7 19 ml Plasma Coated ALUMINIUM CAN 10 0.48 mm OD ACTUATORS WITH DUST COVERS / CAPS Relevant, as per Packing Policy and General Notes. Ipratropium Pressurised Inhalation 20 mcg / Ipravent 20 mcg Inhaler (200MD) (Ipramar 20mcg Inhaler / INFLUMIX 20MCG (200MD) with 63 mcl Aerosol Valve, 19ml Plasma Coated Aluminium Can with 0.48 mm Actuator HFA 227 Gas 21.30 gms) 1 Number 13 Heptafluropropane P227 Gas (HFA-227) 21.12 mg. 2 Ipratropium Bromide 8.00 mg. 5 63 mcl AEROSOL VALVES 8 19 ml Plasma Coated ALUMINIUM CAN 11 0.48 mm OD ACTUATORS WITH DUST COVERS / CAPS Relevant, as per Packing Policy and General Notes. Ipratropium Pressurised Inhalation 40 mcg / Ipravent 40 mcg Inhaler (200MD) Ipramar 40 mcg Inhaler (with 63 mcl Aerosol Valve, 19 ml Plasma Coated Aluminium Can with 0.48 mm Actuator HFA 227 Gas 21.25 gms) 1 Number 14 Heptafluropropane

aler (200MD) Ipramar 40 mcg Inhaler (with 63 mcl Aerosol Valve, 19 ml Plasma Coated Aluminium Can with 0.48 mm Actuator HFA 227 Gas 21.25 gms) 1 Number 14 Heptafluropropane P227 Gas 21.12 mg. 3 Ipratropium Bromide 4.00 mg. Ipratropium Bromide 20 mcg 1 Number|Norms Committee Decision: The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Ipratropium Bromide 4.00 mg. 4 63 mcl AEROSOL VALVES 7 19 ml Plasma Coated ALUMINIUM CAN 10 0.48 mm OD ACTUATORS WITH DUST COVERS / CAPS Relevant, as per Packing Policy and General Notes. Ipratropium Pressurised Inhalation 20 mcg / Ipravent 20 mcg Inhaler (200MD) (Ipramar 20mcg Inhaler / INFLUMIX 20MCG (200MD) with 63 mcl Aerosol Valve, 19ml Plasma Coated Aluminium Can with 0.48 mm Actuator HFA 227 Gas 21.30 gms) 1 Number 13 Heptafluropropane P227 Gas (HFA-227) 21.12 mg. 2 Ipratropium Bromide 8.00 mg. 5 63 mcl AEROSOL VALVES 8 19 ml Plasma Coated ALUMINIUM CAN 11 0.48 mm OD ACTUATORS WITH DUST COVERS / CAPS Relevant, as per Packing Policy and General Notes. Ipratropium Pressurised Inhalation 40 mcg / Ipravent 40 mcg Inhaler (200MD) Ipramar 40 mcg Inhaler (with 63 mcl Aerosol Valve, 19 ml Plasma Coated Alumin

and General Notes. Ipratropium Pressurised Inhalation 40 mcg / Ipravent 40 mcg Inhaler (200MD) Ipramar 40 mcg Inhaler (with 63 mcl Aerosol Valve, 19 ml Plasma Coated Aluminium Can with 0.48 mm Actuator HFA 227 Gas 21.25 gms) 1 Number 14 Heptafluropropane P227 Gas 21.12 mg. 3 Ipratropium Bromide 4.00 mg. Ipratropium Bromide 20 mcg 1 Number|Norms Committee Decision: The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Ipratropium Bromide 4.00 mg. 4 63 mcl AEROSOL VALVES 7 19 ml Plasma Coated ALUMINIUM CAN 10 0.48 mm OD ACTUATORS WITH DUST COVERS / CAPS Relevant, as per Packing Policy and General Notes. Ipratropium Pressurised Inhalation 20 mcg / Ipravent 20 mcg Inhaler (200MD) (Ipramar 20mcg Inhaler / INFLUMIX 20MCG (200MD) with 63 mcl Aerosol Valve, 19ml Plasma Coated Aluminium Can with 0.48 mm Actuator HFA 227 Gas 21.30 gms) 1 Number 13 Heptafluropropane P227 Gas (HFA-227) 21.12 mg. 2 Ipratropium Bromide 8.00 mg. 5 63 mcl AEROSOL VALVES 8 19 ml Plasma Coated ALUMINIUM CAN 11 0.48 mm OD ACTUATORS WITH DUST COVERS / CAPS Relevant, as per Packing Policy and General Notes. Ipratropium Pressurised Inhalation 40 mcg / Ipravent 40 mcg Inhaler

11 0.48 mm OD ACTUATORS WITH DUST COVERS / CAPS Relevant, as per Packing Policy and General Notes. Ipratropium Pressurised Inhalation 40 mcg / Ipravent 40 mcg Inhaler (200MD) Ipramar 40 mcg Inhaler (with 63 mcl Aerosol Valve, 19 ml Plasma Coated Aluminium Can with 0.48 mm Actuator HFA 227 Gas 21.25 gms) 1 Number 14 Heptafluropropane P227 Gas 21.12 mg. 3 Ipratropium Bromide 4.00 mg. Ipratropium Bromide 20 mcg 1 Number|Norms Committee Decision: The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Ipratropium Bromide 4.00 mg. 4 63 mcl AEROSOL VALVES 7 19 ml Plasma Coated ALUMINIUM CAN 10 0.48 mm OD ACTUATORS WITH DUST COVERS / CAPS Relevant, as per Packing Policy and General Notes. Ipratropium Pressurised Inhalation 20 mcg / Ipravent 20 mcg Inhaler (200MD) (Ipramar 20mcg Inhaler / INFLUMIX 20MCG (200MD) with 63 mcl Aerosol Valve, 19ml Plasma Coated Aluminium Can with 0.48 mm Actuator HFA 227 Gas 21.30 gms) 1 Number 13 Heptafluropropane P227 Gas (HFA-227) 21.12 mg. 2 Ipratropium Bromide 8.00 mg. 5 63 mcl AEROSOL VALVES 8 19 ml Plasma Coated ALUMINIUM CAN 11 0.48 mm OD ACTUATORS WITH DUST COVERS / CAPS Relevant, as per Packing Policy

Bromide 8.00 mg. 5 63 mcl AEROSOL VALVES 8 19 ml Plasma Coated ALUMINIUM CAN 11 0.48 mm OD ACTUATORS WITH DUST COVERS / CAPS Relevant, as per Packing Policy and General Notes. Ipratropium Pressurised Inhalation 40 mcg / Ipravent 40 mcg Inhaler (200MD) Ipramar 40 mcg Inhaler (with 63 mcl Aerosol Valve, 19 ml Plasma Coated Aluminium Can with 0.48 mm Actuator HFA 227 Gas 21.25 gms) 1 Number 14 Heptafluropropane P227 Gas 21.12 mg. 3 Ipratropium Bromide 4.00 mg. Ipratropium Bromide 20 mcg 1 Number|Norms Committee Decision: The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Ipratropium Bromide 4.00 mg. 4 63 mcl AEROSOL VALVES 7 19 ml Plasma Coated ALUMINIUM CAN 10 0.48 mm OD ACTUATORS WITH DUST COVERS / CAPS Relevant, as per Packing Policy and General Notes. Ipratropium Pressurised Inhalation 20 mcg / Ipravent 20 mcg Inhaler (200MD) (Ipramar 20mcg Inhaler / INFLUMIX 20MCG (200MD) with 63 mcl Aerosol Valve, 19ml Plasma Coated Aluminium Can with 0.48 mm Actuator HFA 227 Gas 21.30 gms) 1 Number 13 Heptafluropropane P227 Gas (HFA-227) 21.12 mg. 2 Ipratropium Bromide 8.00 mg. 5 63 mcl AEROSOL VALVES 8 19 ml Plasma Coated ALUMINIUM CAN

gms) 1 Number 13 Heptafluropropane P227 Gas (HFA-227) 21.12 mg. 2 Ipratropium Bromide 8.00 mg. 5 63 mcl AEROSOL VALVES 8 19 ml Plasma Coated ALUMINIUM CAN 11 0.48 mm OD ACTUATORS WITH DUST COVERS / CAPS Relevant, as per Packing Policy and General Notes. Ipratropium Pressurised Inhalation 40 mcg / Ipravent 40 mcg Inhaler (200MD) Ipramar 40 mcg Inhaler (with 63 mcl Aerosol Valve, 19 ml Plasma Coated Aluminium Can with 0.48 mm Actuator HFA 227 Gas 21.25 gms) 1 Number 14 Heptafluropropane P227 Gas 21.12 mg. 3 Ipratropium Bromide 4.00 mg. Ipratropium Bromide 20 mcg 1 Number|Norms Committee Decision: The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:- Export Product Qty. Sl. No. Import Items **Qty.

c norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Ipratropium Bromide 4.00 mg. 4 63 mcl AEROSOL VALVES 7 19 ml Plasma Coated ALUMINIUM CAN 10 0.48 mm OD ACTUATORS WITH DUST COVERS / CAPS Relevant, as per Packing Policy and General Notes. Ipratropium Pressurised Inhalation 20 mcg / Ipravent 20 mcg Inhaler (200MD) (Ipramar 20mcg Inhaler / INFLUMIX 20MCG (200MD) with 63 mcl Aerosol Valve, 19ml Plasma Coated Aluminium Can with 0.48 mm Actuator HFA 227 Gas 21.30 gms) 1 Number 13 Heptafluropropane P227 Gas (HFA-227) 21.12 mg. 2 Ipratropium Bromide 8.00 mg. 5 63 mcl AEROSOL VALVES 8 19 ml Plasma Coated ALUMINIUM CAN 11 0.48 mm OD ACTUATORS WITH DUST COVERS / CAPS Relevant, as per Packing Policy and General Notes. Ipratropium Pressurised Inhalation 40 mcg / Ipravent 40 mcg Inhaler (200MD) Ipramar 40 mcg Inhaler (with 63 mcl Aerosol Valve, 19 ml Plasma Coated Aluminium Can with 0.48 mm Actuator HFA 227 Gas 21.25 gms) 1 Number 14 Heptafluropropane P227 Gas 21.12 mg. 3 Ipratropium Bromide 4.00 mg. Ipratropium Bromide 20 mcg 1 Number| |---|---|---|---|---|---| ||Export Product|Qty.|Sl. No.|Import Items|**Qty.

Gas 21.12 mg. 3 Ipratropium Bromide 4.00 mg. Ipratropium Bromide 20 mcg 1 Number| |---|---|---|---|---|---| ||Export Product|Qty.|Sl. No.|Import Items|Qty. allowed.| ||Ipratropium Pressurised Inhalation 20 mcg / Ipravent 20 mcg Inhaler (200MD) (Ipramar 20mcg Inhaler / INFLUMIX 20MCG (200MD) with 63 mcl Aerosol Valve, 19ml Plasma Coated Aluminium Can with 0.48 mm Actuator HFA 227 Gas 21.30 gms)|1 Number|1|Ipratropium Bromide|4.00 mg.| ||||4|63 mcl AEROSOL VALVES|Relevant, as per Packing Policy and General Notes.| ||||7|19 ml Plasma Coated ALUMINIUM CAN|| ||||10|0.48 mm OD ACTUATORS WITH DUST COVERS / CAPS|| ||||13|Heptafluropropane P227 Gas (HFA-227)|21.12 mg.| ||Ipratropium Pressurised Inhalation 40 mcg / Ipravent 40 mcg Inhaler (200MD) Ipramar 40 mcg Inhaler (with 63 mcl Aerosol Valve, 19 ml Plasma Coated Aluminium Can with 0.48 mm Actuator HFA 227 Gas 21.25 gms)|1 Number|2|Ipratropium Bromide|8.00 mg.| ||||5|63 mcl AEROSOL VALVES|Relevant, as per Packing Policy and General Notes.| ||||8|19 ml Plasma Coated ALUMINIUM CAN|| ||||11|0.48 mm OD ACTUATORS WITH DUST COVERS / CAPS|| ||||14|Heptafluropropane P227 Gas|21.12 mg.| ||Ipratropium Bromide 20 mcg|1 Number|3|Ipratropium Bromide|4.00 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

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0 mcg|1 Number|3|Ipratropium Bromide|4.00 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

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6	63 mcl AEROSOL<br>VALVES	Relevant, as per<br>Packing Policy<br>and General<br>Notes.
9	19 ml Plasma Coated<br>ALUMINIUM CAN
12	0.58 mm OD<br>ACTUATORS WITH<br>DUST COVERS / CAPS
15	Heptafluropropane P227<br>Gas	21.12 mg.

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

NIUM CAN|| ||||12|0.58 mm OD ACTUATORS WITH DUST COVERS / CAPS|| ||||15|Heptafluropropane P227 Gas|21.12 mg.|

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

Case No.	11 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	SUPERMINT EXPORTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM REVIW00000309AM26
RA File Number	292404000010 AM20
Licence No and<br>Date	2910025424/19/08/2019
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the<br>firm has not provided any technical justification / information for enhancement. Hence, the committee<br>didn’t find any merit to review the norms and it was decided to reject the case maintaining the status quo.

Case No.	12 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	HIKAL LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

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e|NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

HQ File Number	HQRNORM REVIW00003939AM26
RA File Number	NA
Licence No and Date	0310837840/24/08/2020
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.<br>No.<br>Import Items<br>Qty. allowed.<br>1<br>(BPPA)3-Bromo-4-chloro-1-<br>(3-chloro-2-pyridyl)-2-<br>{[(1RS)-1-cyclopropylethyl]<br>carbamoyl}pyrazole-5-<br>carboxanilide<br>0.966 kg.<br>2<br>Ethyl Acetate<br>1.72 kg.<br>3<br>Bromine<br>0.40 kg.<br>4<br>Caustic Soda<br>0.087 kg.<br>5<br>Sulphuric Acid<br>0.04 kg.<br>Cyclaniliprole Technical 95.00%<br>w/w min. (Cyclaniliprole (IKI-<br>3106)<br>1 kg.<br>6<br>Sodium bicarbonate<br>0.081 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	13 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM REVIW00006674AM25
RA File Number	26AA04002063 AM22
Licence No and Date	2611000198/13/07/2021

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Norms Committee Decision:

The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
(S,E)-4-((tert-<br>butyldimethylsilyl)oxy)pent-2-enal	1346 kg.	1	L-Ethyl lactate	2000 kg.
		2	Imidazole	1400 kg.
		3	TBDMS Chloride	2040 kg.
		4	(Formylmethylene)<br>triphenylphosphorane	4675 kg.
		5	Potassium sodium<br>tartrate tetrahydrate	6250 kg.
		6	Heptane	8220 Litre

Case No.	14 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00192148AM22
RA File Number	03AA04091496 AM22
Licence No and<br>Date	0311007180/23/09/2021
Norms Committee Decision:<br>The Committee considered the case as per the agenda and noted that the firm has failed to furnish a reply<br>to the deficiency letter despite repeated reminders and adequate opportunities being provided. In the

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

absence of the required information and documents, the Committee decided to reject the case.

FT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

absence of the required information and documents, the Committee decided to reject the case.

Case No.	15 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	ZIM LABORATORIES LIMITED.
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000002AM26
RA File Number	NA
Licence No and<br>Date	5011000387/08/02/2022
Norms Committee Decision:<br>The Committee observed that the firm has applied for authorization under the Self-Ratification Scheme in terms of para 4.06<br>of the FTP read with para 4.07A of the HBP, while simultaneously seeking fixation of norms under para 4.07 of the HBP. In<br>view of the above, the NC decided to close the case and advised the firm as well as the concerned RA to take action in<br>accordance with the relevant provisions of para 4.06 of the FTP and para 4.07A of the HBP.

Case No.	16 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	KEVA FRAGRANCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM REVIW00001406AM25
RA File Number	03AX04000821 AM23
Licence No and<br>Date	0311015467/13/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished<br>the reply of deficiency letter. Hence, the Committee decided to give one more opportunity to furnish the<br>required documents.

nda and it was observed that the firm still has not furnished the reply of deficiency letter. Hence, the Committee decided to give one more opportunity to furnish the required documents.||

Case No.	17 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	GLENMARK PHARMACEUTICALS LIMITED

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM REVIW00006545AM25
RA File Number	03AX04001157 AM23
Licence No and<br>Date	0311015490/14/06/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the<br>firm has not provided any technical justification / information for enhancement. Hence, the committee<br>didn’t find any merit to review the norms and it was decided to reject the case maintaining the status quo.

ed any technical justification / information for enhancement. Hence, the committee didn’t find any merit to review the norms and it was decided to reject the case maintaining the status quo.||

Case No.	18 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	SUDEEP PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00002560AM23
RA File Number	34AX04000414 AM23
Licence No and<br>Date	3411002630/10/08/2022
Norms Committee Decision:<br>The Committee considered the case as per the agenda and noted that the firm has failed to furnish a reply<br>to the deficiency letter despite repeated reminders and adequate opportunities being provided. In the<br>absence of the required information and documents, the Committee decided to reject the case and firm<br>has advised to pay customs duty on import items and regularize the case.

Case No.	19 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	HIKAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00004443AM23
RA File Number	34AX04000759 AM23
Licence No and<br>Date	3411003012/18/11/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

erved that the firm still has not furnished||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

the reply of deficiency letter. Hence, the Committee decided to give one more opportunity to furnish the required documents.

Case No.	20 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	DELTA FINOCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00004995AM23
RA File Number	03AX04004505 AM23
Licence No and<br>Date	0311019991/15/12/2022
Norms Committee Decision:<br>The Committee considered the case as per the agenda and noted that the firm has failed to furnish a reply to<br>the deficiency letter despite repeated reminders and adequate opportunities being provided. In the absence<br>of the required information and documents, the Committee decided to reject the case and firm has advised<br>to pay customs duty on import items and regularize the case.

d. In the absence of the required information and documents, the Committee decided to reject the case and firm has advised to pay customs duty on import items and regularize the case.||

Case No.	Case No.	21 / NC/3/MEET/Dec/202526/11	21 / NC/3/MEET/Dec/202526/11	21 / NC/3/MEET/Dec/202526/11	21 / NC/3/MEET/Dec/202526/11	21 / NC/3/MEET/Dec/202526/11
Case Status		Case Approved
Party Name		SCOTT EDIL PHARMACIA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number		HQRNORM REVIW00000095AM26
RA File Number		30AX04000539 AM23
Licence No and<br>Date		3011003243/07/03/2023
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.<br>No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl.<br>No.	Import Items	Qty. allowed.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

r>No.|Import Items|Qty. allowed.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

1<br>Nystatin USP<br>(Potency 3333 IU/mg.)<br>3045.0 kg.<br>Nystatin Oral Suspension USP<br>100000 IU/ML (Each 1ML<br>suspension contain : Nystatin USP<br>100000 IU in flover base q.s. Colour<br>: Colour base approved)<br>(30 ML Bottle contains 100000<br>IU/ML & 100000 IU = 3 mg) (Net<br>content of Nystatin not less than<br>2900 Kgs))<br>3222222<br>Numbers<br>2<br>Sucralose<br>2552.0 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Nystatin Oral Suspension USP<br>100000 IU/ML (Each 1ML<br>suspension contain : Nystatin USP<br>100000 IU in flover base q.s. Colour<br>: Colour base approved)<br>(30 ML Bottle contains 100000<br>IU/ML & 100000 IU = 3 mg) (Net<br>content of Nystatin not less than<br>2900 Kgs))	3222222<br>Numbers	1	Nystatin USP<br>(Potency 3333 IU/mg.)	3045.0 kg.
			2	Sucralose	2552.0 kg.

000 IU = 3 mg) (Net content of Nystatin not less than 2900 Kgs))|3222222 Numbers|1|Nystatin USP (Potency 3333 IU/mg.)|3045.0 kg.| |---|---|---|---|---|---| ||||2|Sucralose|2552.0 kg.|

Case No.	22 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	MEONE HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM REVIW00000082AM26
RA File Number	04AX04000118 AM24
Licence No and<br>Date	0411005383/10/05/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the<br>firm has not provided any technical justification / information for enhancement. Hence, the committee<br>didn’t find any merit to review the norms and it was decided to reject the case maintaining the status quo.

Case No.	23 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	SATYADEVA PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000775AM24
RA File Number	09AX04000090 AM24
Licence No and	0911005025/11/05/2023

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Date

Norms Committee Decision:

The Committee considered the case as per the agenda and noted that the firm has failed to furnish a reply to the deficiency letter despite repeated reminders and adequate opportunities being provided. In the absence of the required information and documents, the Committee decided to reject the case and firm has advised to pay customs duty on import items and regularize the case.

Case No.	24 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	SARAL CHEMTECH LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000865AM24
RA File Number	33AX04000105 AM23
Licence No and<br>Date	3311001206/16/05/2023
Norms Committee Decision:<br>The firm was called for Personal Hearing on 18.12.2025 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.	25 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	INNOVARE LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000950AM24
RA File Number	09AX04000137 AM24
Licence No and<br>Date	0911005059/18/05/2023
Norms Committee Decision:<br>The Committee considered the case as per the agenda and noted that the firm has failed to furnish a reply<br>to the deficiency letter despite repeated reminders and adequate opportunities being provided. In the<br>absence of the required information and documents, the Committee decided to reject the case and firm<br>has advised to pay customs duty on import items and regularize the case.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

y on import items and regularize the case.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Case No.	26 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	OAN INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
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 firm was called for Personal Hearing on 18.12.2025 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.	27 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	SHREE GANESH REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00001244AM24
RA File Number	34AX04000140 AM24
Licence No and<br>Date	3411003769/01/06/2023
Norms Committee Decision:<br>The Committee considered the case as per the agenda and noted that the firm has failed to furnish a reply<br>to the deficiency letter despite repeated reminders and adequate opportunities being provided. In the<br>absence of the required information and documents, the Committee decided to reject the case and firm<br>has advised to pay customs duty on import items and regularize the case.

ed. In the absence of the required information and documents, the Committee decided to reject the case and firm has advised to pay customs duty on import items and regularize the case.||

Case No.	28 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	UNIMAX LABORATORIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

HQ File Number	HQ File Number	HQRNORM REVIW00000489AM26	HQRNORM REVIW00000489AM26	HQRNORM REVIW00000489AM26	HQRNORM REVIW00000489AM26	HQRNORM REVIW00000489AM26
RA File Number		05AX04000673 AM24
Licence No and<br>Date		0511019298/12/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

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. Azithromycin Tablets 250 mg IP(Each tablet contains : Azithromycin IP (As Dihydrate) Eq. to Anhydrous Azithromycin) 1 Number 1 Azithromycin Dihydrate IP 267.27 mg. Azithromycin Tablets 500 mg IP(Each tablet contains : Azithromycin IP (As Dihydrate) Eq. to Anhydrous Azithromycin) 1 Number 2 Azithromycin Dihydrate IP 534.54 mg. Spiramycin Tablets 1.5 MIU(Each tablet contains Spiramycin EP 1.5 million i.u. Eq. to (379.12 mg / tablet)) 1 Number 3 Spiramycin EP 373.02 mg. Spiramycin Tablets 3.0 MIU(Each tablet contains Spiramycin EP 1.5 million i.u. Eq. to (758.24 mg / tablet)) 1 Number 4 Spiramycin EP 746.04 mg. Azithromycin Tablets 250 mg USP(Each tablet contains : Azithromycin USP (As Dihydrate) Eq. to Anhydrous Azithromycin) 1 Number 5 Azithromycin Dihydrate USP 267.27 mg. Azithromycin Tablets 500 mg USP(Each tablet contains : Azithromycin USP (As Dihydrate) Eq. to Anhydrous Azithromycin) 1 Number 6 Azithromycin Dihydrate USP 534.54 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|**Qty.

hromycin USP (As Dihydrate) Eq. to Anhydrous Azithromycin) 1 Number 6 Azithromycin Dihydrate USP 534.54 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Azithromycin Tablets 250 mg IP(Each tablet contains : Azithromycin IP (As Dihydrate) Eq. to Anhydrous Azithromycin)||1 Number|1|Azithromycin Dihydrate IP|267.27 mg.| ||Azithromycin Tablets 500 mg IP(Each tablet contains : Azithromycin IP (As Dihydrate) Eq. to Anhydrous Azithromycin)||1 Number|2|Azithromycin Dihydrate IP|534.54 mg.| ||Spiramycin Tablets 1.5 MIU(Each tablet contains Spiramycin EP 1.5 million i.u. Eq. to (379.12 mg / tablet))||1 Number|3|Spiramycin EP|373.02 mg.| ||Spiramycin Tablets 3.0 MIU(Each tablet contains Spiramycin EP 1.5 million i.u. Eq. to (758.24 mg / tablet))||1 Number|4|Spiramycin EP|746.04 mg.| ||Azithromycin Tablets 250 mg USP(Each tablet contains : Azithromycin USP (As Dihydrate) Eq. to Anhydrous Azithromycin)||1 Number|5|Azithromycin Dihydrate USP|267.27 mg.| ||Azithromycin Tablets 500 mg USP(Each tablet contains : Azithromycin USP (As Dihydrate) Eq. to Anhydrous Azithromycin)||1 Number|6|Azithromycin Dihydrate USP|534.54 mg.|

P|267.27 mg.| ||Azithromycin Tablets 500 mg USP(Each tablet contains : Azithromycin USP (As Dihydrate) Eq. to Anhydrous Azithromycin)||1 Number|6|Azithromycin Dihydrate USP|534.54 mg.|

HQ File Number	HQ File Number	HQRNORM REVIW00000489AM26	HQRNORM REVIW00000489AM26	HQRNORM REVIW00000489AM26	HQRNORM REVIW00000489AM26	HQRNORM REVIW00000489AM26
RA File Number		05AX04000673 AM24
Licence No and<br>Date		0511019298/12/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Azithromycin Tablets 250 mg<br>IP(Each tablet contains :<br>Azithromycin IP (As Dihydrate) Eq.<br>to Anhydrous Azithromycin)<br>1 Number<br>1<br>Azithromycin<br>Dihydrate IP<br>267.27 mg.<br>Azithromycin Tablets 500 mg<br>IP(Each tablet contains :<br>Azithromycin IP (As Dihydrate) Eq.<br>to Anhydrous Azithromycin)<br>1 Number<br>2<br>Azithromycin<br>Dihydrate IP<br>534.54 mg.<br>Spiramycin Tablets 1.5 MIU(Each<br>tablet contains Spiramycin EP 1.5<br>million i.u. Eq. to (379.12 mg /<br>tablet))<br>1 Number<br>3<br>Spiramycin EP<br>373.02 mg.<br>Spiramycin Tablets 3.0 MIU(Each<br>tablet contains Spiramycin EP 1.5<br>million i.u. Eq.

ycin EP 1.5 million i.u. Eq. to (379.12 mg / tablet)) 1 Number 3 Spiramycin EP 373.02 mg. Spiramycin Tablets 3.0 MIU(Each tablet contains Spiramycin EP 1.5 million i.u. Eq. to (758.24 mg / tablet)) 1 Number 4 Spiramycin EP 746.04 mg. Azithromycin Tablets 250 mg USP(Each tablet contains : Azithromycin USP (As Dihydrate) Eq. to Anhydrous Azithromycin) 1 Number 5 Azithromycin Dihydrate USP 267.27 mg. Azithromycin Tablets 500 mg USP(Each tablet contains : Azithromycin USP (As Dihydrate) Eq. to Anhydrous Azithromycin) 1 Number 6 Azithromycin Dihydrate USP 534.54 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Azithromycin Tablets 250 mg IP(Each tablet contains : Azithromycin IP (As Dihydrate) Eq. to Anhydrous Azithromycin)||1 Number|1|Azithromycin Dihydrate IP|267.27 mg.| ||Azithromycin Tablets 500 mg IP(Each tablet contains : Azithromycin IP (As Dihydrate) Eq. to Anhydrous Azithromycin)||1 Number|2|Azithromycin Dihydrate IP|534.54 mg.| ||Spiramycin Tablets 1.5 MIU(Each tablet contains Spiramycin EP 1.5 million i.u. Eq. to (379.12 mg / tablet))||1 Number|3|Spiramycin EP|373.02 mg.| ||Spiramycin Tablets 3.0 MIU(Each tablet contains Spiramycin EP 1.5 million i.u. Eq. to (758.24 mg / tablet))||1 Number|4|Spiramycin EP|746.04 mg.| ||Azithromycin Tablets 250 mg USP(Each tablet contains : Azithromycin USP (As Dihydrate) Eq.

ycin EP 1.5 million i.u. Eq. to (758.24 mg / tablet))||1 Number|4|Spiramycin EP|746.04 mg.| ||Azithromycin Tablets 250 mg USP(Each tablet contains : Azithromycin USP (As Dihydrate) Eq. to Anhydrous Azithromycin)||1 Number|5|Azithromycin Dihydrate USP|267.27 mg.| ||Azithromycin Tablets 500 mg USP(Each tablet contains : Azithromycin USP (As Dihydrate) Eq. to Anhydrous Azithromycin)||1 Number|6|Azithromycin Dihydrate USP|534.54 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Case No.	29 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	ARCH PROTECTION CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00001705AM24
RA File Number	03AX04001182 AM24
Licence No and<br>Date	0311024600/16/06/2023
Norms Committee Decision:<br>The Committee considered the case as per the agenda and noted that the firm has failed to furnish a reply<br>to the deficiency letter despite repeated reminders and adequate opportunities being provided. In the<br>absence of the required information and documents, the Committee decided to reject the case and firm<br>has advised to pay customs duty on import items and regularize the case.

ed. In the absence of the required information and documents, the Committee decided to reject the case and firm has advised to pay customs duty on import items and regularize the case.||

Case No.	30 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	BULI CHEMICALS INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM REVIW00006792AM25
RA File Number	03AX04001475 AM24
Licence No and<br>Date	0311025181/06/07/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>To indicate the exact percentage of Hexane in export item, because the requirement of raw materials will be<br>different in different concentration.<br>1.<br>Complete chemical reaction of reactant and product indicating molecular weight of each chemical and yield of the<br>rection and accordingly calculate the requirement.<br>2.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

The commercial value of by-product Lithium Chloride, supported by invoices.
Stoichiometric material balance of the reaction.

To indicate indigenous items in Annexure to Appendix-4E.

M26

The commercial value of by-product Lithium Chloride, supported by invoices.
Stoichiometric material balance of the reaction.

To indicate indigenous items in Annexure to Appendix-4E.

Case No.	31 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00004796AM24
RA File Number	34AX04000209 AM24
Licence No and<br>Date	3411003978/02/08/2023
Norms Committee Decision:<br>The Committee considered the case as per the agenda and noted that the firm has failed to furnish a reply<br>to the deficiency letter despite repeated reminders and adequate opportunities being provided. In the<br>absence of the required information and documents, the Committee decided to reject the case and firm<br>has advised to pay customs duty on import items and regularize the case.

Case No.	32 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00004944AM24
RA File Number	07AX04000704 AM24
Licence No and<br>Date	0711008930/09/08/2023
Norms Committee Decision:<br>The Committee considered the case as per the agenda and noted that the firm has failed to furnish a reply<br>to the deficiency letter despite repeated reminders and adequate opportunities being provided.

Committee considered the case as per the agenda and noted that the firm has failed to furnish a reply to the deficiency letter despite repeated reminders and adequate opportunities being provided. In the absence of the required information and documents, the Committee decided to reject the case and firm has advised to pay customs duty on import items and regularize the case.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Case No.	33 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	INTIGREAT CONSULTING SERVICES LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00006403AM24
RA File Number	03AX04003028 AM24
Licence No and<br>Date	0311028103/23/10/2023
Norms Committee Decision:
The Committee considered the case as per the agenda and noted that the firm has failed to furnish a reply
to the deficiency letter despite repeated reminders and adequate opportunities being provided. In the
absence of the required information and documents, the Committee decided to reject the case and firm
has advised to pay customs duty on import items and regularize the case.

ed. In the|| |absence of the required information and documents, the Committee decided to reject the case and firm|| |has advised to pay customs duty on import items and regularize the case.||

Case No.	34 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	SANDOZ PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00006418AM24
RA File Number	03AX04003201 AM24
Licence No and<br>Date	0311028115/23/10/2023
Norms Committee Decision:
The Committee considered the case as per the agenda and noted that the firm has failed to furnish a reply
to the deficiency letter despite repeated reminders and adequate opportunities being provided. In the
absence of the required information and documents, the Committee decided to reject the case and firm
has advised to pay customs duty on import items and regularize the case.
.

Case No.	35 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

|NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

and Date
HQ File Number	HQRNORM REVIW00000250AM26
RA File Number	03AX04004064 AM24
Licence No and<br>Date	0311029280/12/12/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, the committee didn’t<br>find any merit to review the norms and it was decided to reject the case maintaining the status quo.

Case No.	36 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	NAVIN FLUORINE INTERNATIONAL LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM REVIW00006578AM25
RA File Number	03AX04003989 AM24
Licence No and Date	0311029847/03/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.

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 4-Cyanopyridine (4-CP) 0.51 kg. QEU76( 4-piperidinecarbothioamide, 1- [2-[5-methyl-3-(trifluoromethyl)-1H- pyrazol-1-yl] acetyl]- piperidine-4- carbothioamide) (QEU 76)) 1 kg. 2 ETFA (Ethyl trifluoroacetate) 0.59 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No. 37 / NC/3/MEET/Dec/202526/11

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Case Status	Case Deferred
Party Name	ALPHAMED FORMULATIONS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00007770AM24
RA File Number	09AX04000867 AM24
Licence No and<br>Date	0911006493/05/01/2024
Norms Committee Decision:<br>The Representative of the firm had attended the Personal Hearing and explained the case. The Committee<br>heard the explanation of Representative of the firm and after due deliberation the firm was advised to get the<br>Advanced Authorisation amended to show each export item separately with corresponding import.

lanation of Representative of the firm and after due deliberation the firm was advised to get the Advanced Authorisation amended to show each export item separately with corresponding import.||

The Representative of the firm had attended the Personal Hearing and explained the case. The Committee heard the explanation of Representative of the firm and after due deliberation the firm was advised to get the Advanced Authorisation amended to show each export item separately with corresponding import.

Case No.	38 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	NEOGEN CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00007813AM24
RA File Number	03AX04004498 AM24
Licence No and<br>Date	0311029998/08/01/2024
Norms Committee Decision:<br>The Committee considered the case as per the agenda and noted that the firm has failed to furnish a reply<br>to the deficiency letter despite repeated reminders and adequate opportunities being provided. In the<br>absence of the required information and documents, the Committee decided to reject the case and firm<br>has advised to pay customs duty on import items and regularize the case.

ed. In the absence of the required information and documents, the Committee decided to reject the case and firm has advised to pay customs duty on import items and regularize the case.||

Case No.	39 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00007862AM24
RA File Number	07AX04001619 AM24
Licence No and<br>Date	0711010173/10/01/2024
Norms Committee Decision:

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

ng provided. In the absence of the required information and documents, the Committee decided to reject the case and firm has advised to pay customs duty on import items and regularize the case.

Case No.	40 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00007864AM24
RA File Number	07AX04001614 AM24
Licence No and<br>Date	0711010175/10/01/2024
Norms Committee Decision:
The Committee considered the case as per the agenda and noted that the firm has failed to furnish a reply
to the deficiency	letter despite repeated reminders and adequate opportunities having been provided. In the
absence of the requisite information and documents, the Committee decided to reject the case. The firm
was accordingly	advised to pay the applicable customs duty on the imported items and regularize the case
as per the extant provisions.

ts, the Committee decided to reject the case. The firm|| |was accordingly|advised to pay the applicable customs duty on the imported items and regularize the case| |as per the extant provisions.||

Case No.	41 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	SANPRAS HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00008015AM24
RA File Number	31AX04000283 AM24
Licence No and<br>Date	3111003005/17/01/2024
Norms Committee Decision:
The Committee considered the case as per the agenda and noted that the firm has failed to furnish a reply to
the deficiency letter despite repeated reminders and adequate opportunities having been provided. In the
absence of the requisite information and documents, the Committee decided to reject the case. The firm was
accordingly advised to pay the applicable customs duty on the imported items and regularize the case as per

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

the extant provisions.

ze the case as per||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

the extant provisions.

Case No.	42 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	PRASOL CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00008287AM24
RA File Number	03AX04004987 AM24
Licence No and<br>Date	0311030614/01/02/2024
Norms Committee Decision:
The Committee considered the case as per the agenda and noted that the firm has failed to furnish a reply to
the deficiency letter despite repeated reminders and adequate opportunities having been provided. In the
absence of the requisite information and documents, the Committee decided to reject the case. The firm was
accordingly advised to pay the applicable customs duty on the imported items and regularize the case as per
the extant provisions.

s, the Committee decided to reject the case. The firm was|| |accordingly advised to pay the applicable customs duty on the imported items and regularize the case as per|| |the extant provisions.||

Case No.	43 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	LOZEN PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
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 Representative of the firm had attended the Personal Hearing and explained the case. The Committee<br>heard the explanation of Representative of the firm and after due deliberation the firm was advised to<br>submit the following documents:<br>Copy of AYUSH licence with approved composition.<br>1.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Copy of Master-Batch Formula showing net content of inputs in export.

AMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Copy of Master-Batch Formula showing net content of inputs in export.

Case No.	44 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00008383AM24
RA File Number	07AX04001749 AM24
Licence No and<br>Date	0711010420/06/02/2024
Norms Committee Decision:<br>The Committee considered the case as per the agenda and noted that the firm has failed to furnish a reply to<br>the deficiency letter despite repeated reminders and adequate opportunities having been provided. In the<br>absence of the requisite information and documents, the Committee decided to reject the case. The firm was<br>accordingly advised to pay the applicable customs duty on the imported items and regularize the case as per<br>the extant provisions.

s, the Committee decided to reject the case. The firm was accordingly advised to pay the applicable customs duty on the imported items and regularize the case as per the extant provisions.||

Case No.	45 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM REVIW00006623AM25
RA File Number	05AX04003618 AM24
Licence No and<br>Date	0511023881/09/02/2024
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the<br>firm has not provided any technical justification / information for enhancement. Hence, the committee<br>didn’t find any merit to review the norms and it was decided to reject the case maintaining the status quo.

Case No. 46 / NC/3/MEET/Dec/202526/11

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

uo.||

Case No. 46 / NC/3/MEET/Dec/202526/11

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Case Status	Case Approved
Party Name	CATION PHARMA
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00008519AM24
RA File Number	52AX04000341 AM24
Licence No and<br>Date	5211007357/12/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Alendronate Sodium USP<br>1 kg.<br>1<br>Gamma Aminobutyric Acid<br>0.50 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	47 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	YELLOWSTONE FINE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00008613AM24
RA File Number	03AX04005249 AM24
Licence No and<br>Date	0311031269/16/02/2024

|Meeting Number and Date|NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025| |HQ File Number|HQRNORM APPLY 00008613AM24| |RA File Number|03AX04005249 AM24| |Licence No and Date|0311031269/16/02/2024| |Norms Committee Decision: The Committee considered the case as per the agenda and decided that a report may be called for from the concerned RA on whether the firm has transferred its name from_Yellowstone Fine Chemicals Private_ _Limited_to_M/s Laxmi Organic Industries_in the IEC and other relevant documents, within thirty days from the date of receipt of the letter from DGFT (HQ).||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Case No.	48 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM REVIW00006320AM25
RA File Number	03AX04005442 AM24
Licence No and<br>Date	0311031542/27/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided that the firm may be advised to submit<br>the statement of weighted average of potency/assy of each import consignment relevant to Bill of Entry.

idered the case as per agenda and it was decided that the firm may be advised to submit the statement of weighted average of potency/assy of each import consignment relevant to Bill of Entry.||

Case No.	49 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	RUBICON RESEARCH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00008826AM24
RA File Number	03AX04005194 AM24
Licence No and<br>Date	0311031599/29/02/2024
Norms Committee Decision:<br>The Committee considered the case as per the agenda and noted that the firm has failed to furnish a reply to<br>the deficiency letter despite repeated reminders and adequate opportunities having been provided. In the<br>absence of the requisite information and documents, the Committee decided to reject the case. The firm was<br>accordingly advised to pay the applicable customs duty on the imported items and regularize the case as per<br>the extant provisions.

Case No.	50 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	SALVI CHEMICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00009169AM24
RA File Number	03AX04005784 AM24
Licence No and<br>Date	0311032244/16/03/2024

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

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 chemical route synthesis and molecular weight given required of EDTA Acid should be 0.79 kg./kg. while import is 0.74 kg/kg and EDTA Acid is also shown as indigenous.
Please indicate whether export is Anhydrous or Tri-Hydrate.
Indicate percentage yield of reaction.

Case No.	51 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	SALVI CHEMICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00009206AM24
RA File Number	03AX04005785 AM24
Licence No and<br>Date	0311032328/19/03/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Complete chemical reaction with molecular weight and structural formula and stagewise percentage<br>yield on molar basis.<br>1.<br>As per process of manufacture Methyl Iodide is used while import is only Iodine please explain.<br>2.

Case No.	52 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM REVIW00003616AM26
RA File Number	03AX04000127 AM25
Licence No and<br>Date	0311033003/15/04/2024

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Norms Committee Decision:

The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm has not provided any technical justification / information for enhancement. Hence, the committee didn’t find any merit to review the norms and it was decided to reject the case maintaining the status quo.

Case No.	53 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	ALPHAMED FORMULATIONS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000268AM25
RA File Number	09AX04001014 AM24
Licence No and<br>Date	0911007079/16/04/2024
Norms Committee Decision:<br>The Representative of the firm had attended the Personal Hearing and explained the case. The Committee<br>heard the explanation of Representative of the firm and after due deliberation the firm was advised to get the<br>Advanced Authorisation amended to show each export item separately with corresponding import.

he explanation of Representative of the firm and after due deliberation the firm was advised to get the Advanced Authorisation amended to show each export item separately with corresponding import.

Case No.	54 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	SIGNATURE PHYTOCHEMICAL INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000467AM25
RA File Number	03AX04000380 AM25
Licence No and<br>Date	0311033435/29/04/2024
Norms Committee Decision:<br>The Committee considered the case as per the agenda and noted that the firm has failed to furnish a reply to<br>the deficiency letter despite repeated reminders and adequate opportunities having been provided. In the<br>absence of the requisite information and documents, the Committee decided to reject the case. The firm was<br>accordingly advised to pay the applicable customs duty on the imported items and regularize the case as per<br>the extant provisions.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

e the case as per the extant provisions.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Case No.	55 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	SANPRAS HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000523AM25
RA File Number	31AX04000022 AM25
Licence No and<br>Date	3111003394/02/05/2024
Norms Committee Decision:<br>The Committee considered the case as per the agenda and noted that the firm has failed to furnish a reply to<br>the deficiency letter despite repeated reminders and adequate opportunities having been provided. In the<br>absence of the requisite information and documents, the Committee decided to reject the case. The firm was<br>accordingly advised to pay the applicable customs duty on the imported items and regularize the case as per<br>the extant provisions.

s, the Committee decided to reject the case. The firm was accordingly advised to pay the applicable customs duty on the imported items and regularize the case as per the extant provisions.||

Case No.	56 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	RUBICON RESEARCH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000535AM25
RA File Number	03AX04000486 AM25
Licence No and<br>Date	0311033558/03/05/2024
Norms Committee Decision:<br>The Committee considered the case as per the agenda and noted that the firm has failed to furnish a reply to<br>the deficiency letter despite repeated reminders and adequate opportunities having been provided. In the<br>absence of the requisite information and documents, the Committee decided to reject the case. The firm was<br>accordingly advised to pay the applicable customs duty on the imported items and regularize the case as per<br>the extant provisions.

Case No.	57 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	HEMA DYECHEM PRIVATE LIMITED

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

ed| |Party Name|HEMA DYECHEM PRIVATE LIMITED|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000568AM25
RA File Number	03AX04000390 AM25
Licence No and<br>Date	0311033616/06/05/2024
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has surrendered the
Advance Authorisation to RA, Mumbai, therefore, it was decided to close the application of the firm.

Case No.	58 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000733AM25
RA File Number	03AX04000685 AM25
Licence No and<br>Date	0311033879/15/05/2024
Norms Committee Decision:
The Committee considered the case as per the agenda and noted that the firm has failed to furnish a reply to
the deficiency letter despite repeated reminders and adequate opportunities having been provided. In the
absence of the requisite information and documents, the Committee decided to reject the case. The firm was
accordingly advised to pay the applicable customs duty on the imported items and regularize the case as per
the extant provisions.

s, the Committee decided to reject the case. The firm was|| |accordingly advised to pay the applicable customs duty on the imported items and regularize the case as per|| |the extant provisions.||

Case No.	59 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000747AM25
RA File Number	07AX04000241 AM25
Licence No and<br>Date	0711011310/16/05/2024
Norms Committee Decision:
The Committee considered the case as per the agenda and noted that the firm has failed to furnish a reply to

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

the deficiency letter despite repeated reminders and adequate opportunities having been provided. In the absence of the requisite information and documents, the Committee decided to reject the case. The firm was accordingly advised to pay the applicable customs duty on the imported items and regularize the case as per the extant provisions.

documents, the Committee decided to reject the case. The firm was accordingly advised to pay the applicable customs duty on the imported items and regularize the case as per the extant provisions.

Case No.	60 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	USV PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM REVIW00000261AM26
RA File Number	03AX04000940 AM25
Licence No and<br>Date	0311034134/27/05/2024
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, the committee didn’t<br>find any merit to review the norms and it was decided to reject the case maintaining the status quo.

Case No.	61 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	MANIPAL NATURAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000966AM25
RA File Number	07AX04000258 AM25
Licence No and<br>Date	0711011405/28/05/2024
Norms Committee Decision:<br>The Committee considered the case as per the agenda and noted that the firm has failed to furnish a reply to<br>the deficiency letter despite repeated reminders and adequate opportunities having been provided. In the<br>absence of the requisite information and documents, the Committee decided to reject the case.

e deficiency letter despite repeated reminders and adequate opportunities having been provided. In the absence of the requisite information and documents, the Committee decided to reject the case. The firm was accordingly advised to pay the applicable customs duty on the imported items and regularize the case as per the extant provisions.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Case No.	62 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	AGIO PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000990AM25
RA File Number	03AX04000815 AM25
Licence No and<br>Date	0311034218/29/05/2024
Norms Committee Decision:<br>The Committee considered the case as per the agenda and noted that the firm has failed to furnish a reply to<br>the deficiency letter despite repeated reminders and adequate opportunities having been provided. In the<br>absence of the requisite information and documents, the Committee decided to reject the case. The firm was<br>accordingly advised to pay the applicable customs duty on the imported items and regularize the case as per<br>the extant provisions.

s, the Committee decided to reject the case. The firm was accordingly advised to pay the applicable customs duty on the imported items and regularize the case as per the extant provisions.||

Case No.	63 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM REVIW00000109AM26
RA File Number	09AX04000169 AM25
Licence No and<br>Date	0911007440/18/06/2024
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, the committee didn’t<br>find any merit to review the norms and it was decided to reject the case maintaining the status quo.

Case No.	64 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	USV PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

|NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

HQ File Number	HQRNORM REVIW00006669AM25
RA File Number	03AX04001750 AM25
Licence No and<br>Date	0311035328/10/07/2024
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, the committee didn’t<br>find any merit to review the norms and it was decided to reject the case maintaining the status quo.

Case No.	65 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	HIKAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00001886AM26
RA File Number	NA
Licence No and<br>Date	0311036222/09/08/2024
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/Nov/202526/10 dated 14/11/2025 against advance<br>authorization No.0311026196 dated 10/08/2023, 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.<br>Import Items<br>Qty.

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 3-Picoline 0.170 kg. 2 Mesylchloride 0.247 kg. IKI-3106 (Cyclaniliprole) 1 kg. 3 Sodium sulfite 0.105 kg. RA concerned may take further necessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Case No.	66 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00002626AM25
RA File Number	05AX04001408 AM25
Licence No and<br>Date	0511027294/21/08/2024
Norms Committee Decision:
The committee considered the request of firm for fixation of ad-hoc norms and it has been observed that
details given by	the firms does not related to present case, therefore, it was decided to call for following
information/documents from the firm:-
Complete technical details as per Annexure to Appendix-4E.<br>1.

ms does not related to present case, therefore, it was decided to call for following| |information/documents from the firm:-|| |Complete technical details as per Annexure to Appendix-4E. 1.||

Case No.	67 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	DR.ACHARYA LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM REVIW00003204AM26
RA File Number	03AX04002498 AM25
Licence No and<br>Date	0311036513/21/08/2024
Norms Committee Decision:
The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm
has not provided any technical justification / information for enhancement. Hence, the committee didn’t
find any merit to	review the norms and it was decided to reject the case maintaining the status quo.

Case No.	68 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

|NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

and Date
HQ File Number	HQRNORM APPLY 00003178AM25
RA File Number	05AX04001863 AM25
Licence No and<br>Date	0511027857/20/09/2024
Norms Committee Decision:<br>The Committee considered the case as per the agenda and decided to call the firm for a Personal Hearing<br>before the Norms Committee to explain its case and submit the relevant information/documents. The officer<br>attending the Personal Hearing on behalf of the firm shall not be below the rank of Vice President.

Case No.	69 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00003321AM25
RA File Number	05AX04002052 AM25
Licence No and<br>Date	0511028003/27/09/2024
Norms Committee Decision:<br>The Committee considered the case as per the agenda and decided to call the firm for a Personal Hearing<br>before the Norms Committee to explain its case and submit the relevant information/documents. The officer<br>attending the Personal Hearing on behalf of the firm shall not be below the rank of Vice President.

ms Committee to explain its case and submit the relevant information/documents. The officer attending the Personal Hearing on behalf of the firm shall not be below the rank of Vice President.||

Case No.	70 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	ZENITH DYEINTERMEDIATES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00003609AM26
RA File Number	NA
Licence No and<br>Date	0311037563/01/10/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>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-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
NAS-5((2-DIAZO-1-NAPTHOL-5-<br>SULFONIC ACID, SODIUM SALT))	1 kg.	1	TOBIAS ACID<br>(PURITY MIN. 97%)	0.70 kg.

Note: NC also recommended for making a new SION for above export product.

--|---| |NAS-5((2-DIAZO-1-NAPTHOL-5- SULFONIC ACID, SODIUM SALT))|1 kg.|1|TOBIAS ACID (PURITY MIN. 97%)|0.70 kg.|

Note: NC also recommended for making a new SION for above export product.

Case No.	71 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	ZENITH DYEINTERMEDIATES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00003606AM26
RA File Number	NA
Licence No and<br>Date	0311041411/17/02/2025
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>NAS-5((2-DIAZO-1-NAPTHOL-5-<br>SULFONIC ACID, SODIUM SALT))<br>1 kg.<br>1<br>TOBIAS ACID<br>(PURITY MIN. 97%)<br>0.70 kg.<br>RA concerned may take further necessary action as per above decision of NC.<br>Note: NC also recommended for making a new SION for above export product.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

making a new SION for above export product.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Case No.	72 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	DECCAN NUTRACEUTICALS PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00006568AM25
RA File Number	02AX04000733 AM25
Licence No and Date	0211008274/05/03/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Nalbuphine Hydrochloride<br>1 kg.<br>1<br>Noroxymorphone Base<br>0.97 kg.<br>RA concerned may take further necessary action as per above decision of NC.

No. Import Items Qty. allowed. Nalbuphine Hydrochloride 1 kg. 1 Noroxymorphone Base 0.97 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	73 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00006921AM25
RA File Number	03AX04006549 AM25
Licence No and<br>Date	0311042606/27/03/2025
Norms Committee Decision:<br>The firm was granted an Advance Authorisation for the export product_“COUMARIN”_under<br>Para 4.07 of the Handbook of Procedures (HBP). However, as per Para 4.11(b) of the Foreign<br>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

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

processed under Para 4.06 of the HBP.

It was observed that the firm obtained the authorisation by misdeclaring that its application was covered under the provisions of Para 4.07 , and has not furnished any technical justification/information for the export product. Accordingly, the Committee found no merit in fixing the norms and decided to reject the application.

a 4.07** , and has not furnished any technical justification/information for the export product. Accordingly, the Committee found 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.	Case No.	74 / NC/3/MEET/Dec/202526/11	74 / NC/3/MEET/Dec/202526/11	74 / NC/3/MEET/Dec/202526/11	74 / NC/3/MEET/Dec/202526/11	74 / NC/3/MEET/Dec/202526/11
Case Status		Case Approved
Party Name		SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number		HQRNORM APPLY 00006923AM25
RA File Number		05AX04004435 AM25
Licence No and<br>Date		0511031629/27/03/2025
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/Dec/202425/13 dated 07/01/2025 against advance<br>authorization No. 0511026676 dated 15/07/2024, 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:-<br>Export Product<br>Qty.<br>**Sl.

ed 15/07/2024, 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. Cyclomed Eye Drops 1% 5ml (Each ml contains 10 mg of Cyclopentolate Hydochloride) 1 Pack 1 Cyclopentolate HCL USP 51.00 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Cyclomed Eye Drops 1% 5ml (Each ml contains 10 mg of Cyclopentolate Hydochloride)|| 1 Pack|1|Cyclopentolate HCL USP|51.00 mg.| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Case No.	75 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	DCM NOUVELLE SPECIALTY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00006926AM25
RA File Number	05AX04004410 AM25
Licence No and<br>Date	0511031632/27/03/2025
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

|RA File Number|05AX04004410 AM25| |Licence No and Date|0511031632/27/03/2025| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	Case No.	76 / NC/3/MEET/Dec/202526/11	76 / NC/3/MEET/Dec/202526/11	76 / NC/3/MEET/Dec/202526/11	76 / NC/3/MEET/Dec/202526/11	76 / NC/3/MEET/Dec/202526/11
Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number		HQRNORM APPLY 00006929AM25
RA File Number		05AX04004368 AM25
Licence No and<br>Date		0511031633/27/03/2025
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. Import Items<br>Qty. allowed.<br>Budesonide Inhalation Suspension 0.25<br>mg /2ml (Each ml contains Budesonide<br>0.125 mg) (Equivalent to 6.049 Kg of<br>Bulk Drug))<br>1 Number<br>1<br>Budesonide<br>0.2625 mg
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Budesonide Inhalation Suspension 0.25<br>mg /2ml (Each ml contains Budesonide<br>0.125 mg) (Equivalent to 6.049 Kg of<br>Bulk Drug))		1 Number	1	Budesonide	0.2625 mg

Items**|Qty. allowed.| ||Budesonide Inhalation Suspension 0.25 mg /2ml (Each ml contains Budesonide 0.125 mg) (Equivalent to 6.049 Kg of Bulk Drug))||1 Number|1|Budesonide|0.2625 mg|

Case No.	Case No.	76 / NC/3/MEET/Dec/202526/11	76 / NC/3/MEET/Dec/202526/11	76 / NC/3/MEET/Dec/202526/11	76 / NC/3/MEET/Dec/202526/11	76 / NC/3/MEET/Dec/202526/11
Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number		HQRNORM APPLY 00006929AM25
RA File Number		05AX04004368 AM25
Licence No and<br>Date		0511031633/27/03/2025
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. Import Items<br>Qty. allowed.<br>Budesonide Inhalation Suspension 0.25<br>mg /2ml (Each ml contains Budesonide<br>0.125 mg) (Equivalent to 6.049 Kg of<br>Bulk Drug))<br>1 Number<br>1<br>Budesonide<br>0.2625 mg
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Budesonide Inhalation Suspension 0.25<br>mg /2ml (Each ml contains Budesonide<br>0.125 mg) (Equivalent to 6.049 Kg of<br>Bulk Drug))		1 Number	1	Budesonide	0.2625 mg

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Bulk Drug))||1 Number|1|Budesonide|0.2625 mg|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Budesonide Inhalation Suspension 0.5 mg<br>/2ml (Each ml contains Budesonide 0.25<br>mg) (Equivalent to 10.350 Kg of Bulk<br>Drug)<br>1 Number<br>2<br>Budesonide<br>0.525 mg.<br>Budesonide Inhalation Suspension 1 mg<br>/2ml (Each ml contains Budesonide 0.5<br>mg) (Equivalent to 9.600 Kg of Bulk<br>Drug) (Total 25.999 Kg of Bulk Drug))<br>1 Number<br>3<br>Budesonide<br>1.05 mg.<br>RA concerned may take further necessary action as per above decision of NC.	Budesonide Inhalation Suspension 0.5 mg<br>/2ml (Each ml contains Budesonide 0.25<br>mg) (Equivalent to 10.350 Kg of Bulk<br>Drug)	1 Number	2	Budesonide	0.525 mg.
	Budesonide Inhalation Suspension 1 mg<br>/2ml (Each ml contains Budesonide 0.5<br>mg) (Equivalent to 9.600 Kg of Bulk<br>Drug) (Total 25.999 Kg of Bulk Drug))	1 Number	3	Budesonide	1.05 mg.

-| ||Budesonide Inhalation Suspension 1 mg /2ml (Each ml contains Budesonide 0.5 mg) (Equivalent to 9.600 Kg of Bulk Drug) (Total 25.999 Kg of Bulk Drug))|1 Number|3|Budesonide|1.05 mg.|

Case No.	Case No.	77 / NC/3/MEET/Dec/202526/11	77 / NC/3/MEET/Dec/202526/11	77 / NC/3/MEET/Dec/202526/11	77 / NC/3/MEET/Dec/202526/11	77 / NC/3/MEET/Dec/202526/11
Case Status		Case Approved
Party Name		CALYX CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number		HQRNORM APPLY 00006934AM25
RA File Number		03AX04006615 AM25
Licence No and<br>Date		0311042619/28/03/2025
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/Oct/202526/9 dated 14/10/2025 against advance<br>authorization No. 0311042441 dated 24/03/2025, 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>9H Fluorene<br>0.814 Kg.<br>2<br>DI N Butylamine<br>0.390 Kg.<br>3<br>Sodium Borohydride<br>0.040 Kg.<br>Lumefantrine<br>1 Kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. Allowed.
	Lumefantrine		1 Kg.	1	9H Fluorene	0.814 Kg.
				2	DI N Butylamine	0.390 Kg.
				3	Sodium Borohydride	0.040 Kg.

ne 1 Kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. Allowed.| ||Lumefantrine||1 Kg.|1|9H Fluorene|0.814 Kg.| |||||2|DI N Butylamine|0.390 Kg.| |||||3|Sodium Borohydride|0.040 Kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

	4	Para Chloro Benzaldehyde	0.336 Kg.
	5	Di Methyl Formamide	0.555 Kg.

RA Concerned May Take Further Necessary Action As Per Above Decision Of NC.

Case No.	78 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	AGSON GLOBAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00006936AM25
RA File Number	05AX04004317 AM25
Licence No and<br>Date	0511031656/28/03/2025
Norms Committee Decision:<br>The firm was granted an Advance Authorisation for the export product_“CIS3 Hexenol-Bio_<br>_Synthetic”_under Para 4.07 of the Handbook of Procedures (HBP). However, as per Para 4.11(b)<br>of the Foreign Trade Policy (FTP) 2023, products falling under the category of perfume or<br>perfumery compounds are ineligible for authorisation under Para 4.07 and are mandatorily<br>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.

he authorisation bymisdeclaring that its application was covered under the provisions of Para 4.07, and has not furnished any technical justification/information for the export product. Accordingly, the Committee found 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.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Case No.	79 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	LAXAI LIFE SCIENCES PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00006945AM25
RA File Number	09AX04001195 AM25
Licence No and Date	0911009324/28/03/2025
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his<br>comments.

File Number|09AX04001195 AM25| |Licence No and Date|0911009324/28/03/2025| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	80 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00006951AM25
RA File Number	03AX04006612 AM25
Licence No and<br>Date	0311042664/29/03/2025
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. Import Items<br>Qty. allowed.<br>Meropenem 1000 mg Powder for<br>Solution for Injection or Infusion<br>/ Meropenem Injection 1 gm<br>USP (Net Content Meropenem<br>and Sodium Carbonate 200 kgs.<br>1 Number<br>Vial<br>1<br>Meropenem and Sodium<br>Carbonate (Sterile Bulk) /<br>Meropenem For Injection<br>USP)<br>1.255 gm/Vial<br>RA concerned may take further necessary action as per above decision of NC.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

cessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Case No.	81 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	GALAXY SURFACTANTS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00006965AM25
RA File Number	03AX04006624 AM25
Licence No and<br>Date	0311042693/30/03/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Lauric Acid/ Lauric Acid<br>C1299/ Lauric acid MB/<br>Lauric Acid C1299 MB<br>0.614 kg.<br>Sodium Lauroyl Methyl Taurate<br>(Galsoft SLT (N) / Galsoft SLT (N)<br>MB)<br>1 kg.<br>2<br>N-Methyl Taurine Sodium<br>Salt 62%.<br>0.728 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	82 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	PARAGON FINE AND SPECIALITY CHEMICAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000004AM26
RA File Number	08AX04002207 AM25
Licence No and<br>Date	0811014582/01/04/2025
Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

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 chemistry, chemical reaction, stichiometric balance on molar basis with molecular weight and percentage yield for each step of reaction

Case No.	83 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	PARAGON FINE AND SPECIALITY CHEMICAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000005AM26
RA File Number	08AX04002208 AM25
Licence No and<br>Date	0811014583/01/04/2025
Norms Committee Decision:
The case is under consideration and TE was requested to expedite his comments.

Case No.	84 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	PRIVI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
and Date

HQ File Number	HQRNORM APPLY 00000007AM26
RA File Number	03AX04006652 AM25
Licence No and<br>	0311042725/01/04/2025
Date

Norms Committee<br>Th fi	Decision:<br>td Ad Athiti f th t dt_“Id_
e rm was grane an vance uorsaon or e expor prouc_nomeran_<br>_(Galaxmeran)”_under Para 4.07 of the Handbook of Procedures (HBP).

|Norms Committee Th fi|Decision: td Ad Athiti f th t dt_“Id_| |e rm was grane an vance uorsaon or e expor prouc_nomeran_ _(Galaxmeran)”_under Para 4.07 of the Handbook of Procedures (HBP). However, as per Para 4.11(b) of the Foreign Trade Policy (FTP) 2023, products falling under the category of perfume or perfumery compounds are ineligible for authorisation under Para 4.07 and are mandatorily required to be processed under Para 4.06 of the HBP. || |It was observed that the firm obtained the authorisation bymisdeclaring that its application||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

was covered under the provisions of Para 4.07 , and has not furnished any technical justification/information for the export product. Accordingly, the Committee found no merit in fixing the norms and decided to reject the application.

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.	Case No.	85 / NC/3/MEET/Dec/202526/11	85 / NC/3/MEET/Dec/202526/11	85 / NC/3/MEET/Dec/202526/11	85 / NC/3/MEET/Dec/202526/11	85 / NC/3/MEET/Dec/202526/11
Case Status		Case Approved
Party Name		PANACEA BIOTEC PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number		HQRNORM APPLY 00000013AM26
RA File Number		05AX04004470 AM25
Licence No and<br>Date		0511031696/01/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No. NC/3/MEET/Sep/202526/8 dated 17/09/2025 against advance<br>authorization No.0511030888 dated 13/02/2025, 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.<br>No.<br>Import Items<br>Qty. allowed.<br>Alphadol Capsules (Each Soft Gelatin<br>Capsule Contains: Alfacalcidol 0.25 mcg.)<br>1 Number<br>1<br>Alfacalcidol<br>0.255 mcg.<br>Alphadol-CA Capsules ((Each Soft Gelatin<br>Capsule Contains: Alfacalcidol 0.25 mcg. &<br>Calcium Carbonate 500 mg.

Contains: Alfacalcidol 0.25 mcg.) 1 Number 1 Alfacalcidol 0.255 mcg. Alphadol-CA Capsules ((Each Soft Gelatin Capsule Contains: Alfacalcidol 0.25 mcg. & Calcium Carbonate 500 mg. equivalent to Elemental Calcium 200 mg.)) 1 Number 2 Alfacalcidol 0.255 mcg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Alphadol Capsules (Each Soft Gelatin Capsule Contains: Alfacalcidol 0.25 mcg.)||1 Number|1|Alfacalcidol|0.255 mcg.| ||Alphadol-CA Capsules ((Each Soft Gelatin Capsule Contains: Alfacalcidol 0.25 mcg. & Calcium Carbonate 500 mg. equivalent to Elemental Calcium 200 mg.))||1 Number|2|Alfacalcidol|0.255 mcg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Alphadol	1 mg (Each Soft Glatin Capsule	1 Number	3	Alfacalcidol	1.02 mcg.
Contains:	Alfacalcidol 1.00 mcg.)

@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Alphadol	1 mg (Each Soft Glatin Capsule	1 Number	3	Alfacalcidol	1.02 mcg.
Contains:	Alfacalcidol 1.00 mcg.)

Case No.	86 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	SANOFI CONSUMER HEALTHCARE INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000014AM26
RA File Number	03AX04006677 AM25
Licence No and<br>Date	0311042739/01/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same<br>export product/import item in meeting No. NC/3/MEET/Jul/202526/6 dated 31/07/2025 against advance<br>authorization No.0311039854 dated 24/12/2024, 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:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Festal Dragees (Tablets) Enterosolube 10 x 10s<br>((Total Net Weight of Pancreatin 3738.32 Kgs<br>Strength of Pancreatin 192 mg/Tablet))<br>1 Number<br>Tablet<br>1<br>Pancreatin<br>195.84 mg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	87 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	HI-PURITY CHEMICALS PRIVATE LIMITED

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

rty Name|HI-PURITY CHEMICALS PRIVATE LIMITED|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000015AM26
RA File Number	03AX04006708 AM25
Licence No and<br>Date	0311042741/01/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Halquinol<br>1 kg.<br>1<br>8 Hydroxyquinoline<br>0.77 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	88 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	AZAKEM LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000017AM26
RA File Number	09AX04001123 AM25
Licence No and<br>Date	0911009334/01/04/2025
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	89 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025

.**||

Case No.	89 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

HQ File Number	HQRNORM APPLY 00000026AM26
RA File Number	05AX04004491 AM25
Licence No and<br>Date	0511031702/02/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same<br>export product/import item in meeting No. NC/3/MEET/Sep/202526/8 dated 17/09/2025 against advance<br>authorization No.3411002586 dated 29/07/2022, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Doxepin Hydrochloride Capsules USP 10 mg.<br>1 Number<br>1<br>Doxepin HCL<br>11.353 mg.<br>Doxepin Hydrochloride Capsules USP 25 mg<br>1 Number<br>2<br>Doxepin HCL<br>28.384 mg.<br>Doxepin Hydrochloride Capsules USP 50 mg<br>1 Number<br>3<br>Doxepin HCL<br>56.766 mg.<br>Doxepin Hydrochloride Capsules USP 75 mg<br>1 Number<br>4<br>Doxepin HCL<br>85.152 mg.<br>Doxepin Hydrochloride Capsules USP 100 mg 1 Number<br>5<br>Doxepin HCL<br>113.538<br>mg.<br>RA concerned may take further necessary action as per above decision of NC.

xepin HCL 85.152 mg. Doxepin Hydrochloride Capsules USP 100 mg 1 Number 5 Doxepin HCL 113.538 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	90 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000042AM26
RA File Number	05AX04004489 AM25
Licence No and<br>Date	0511031710/02/04/2025
Norms Committee Decision:

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

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.
Tobramycin Inhalation Solution,<br>300 mg / 4ml	1 Number Pack	1	Tobramycin USP	315 mg./Vial
Tobramycin Inhalation Solution,<br>300 mg / 5ml	1 Number Pack	2	Tobramycin USP	315 mg./Vial

--|---| |Tobramycin Inhalation Solution, 300 mg / 4ml|1 Number Pack|1|Tobramycin USP|315 mg./Vial| |Tobramycin Inhalation Solution, 300 mg / 5ml|1 Number Pack|2|Tobramycin USP|315 mg./Vial|

Case No.	91 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	VIJAYASRI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000053AM26
RA File Number	09AX04001141 AM25
Licence No and<br>Date	0911009349/02/04/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Complete and balance chemical reactions with molecular weight.<br>1.<br>Percentage yield on molar basis for each step.<br>2.<br>Requirement and recovery of solvent.<br>3.

Case No. 92 / NC/3/MEET/Dec/202526/11

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

3.||

Case No. 92 / NC/3/MEET/Dec/202526/11

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000072AM26
RA File Number	07AX04002128 AM25
Licence No and<br>Date	0711014085/02/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Cromolyn Sodium Oral<br>Concentrate Solution<br>(100 mg / 5 ml) 5 ml Net<br>Contents: 1685.491 kg))<br>1 Number<br>1<br>Cromolyn Sodium<br>(Sodium<br>Cromoglycate)<br>BP/EP/USP)<br>0.102 gm.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	93 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	PARAGON FINE AND SPECIALITY CHEMICAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000076AM26
RA File Number	08AX04002246 AM25
Licence No and<br>Date	0811014626/03/04/2025
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

RA File Number|08AX04002246 AM25| |Licence No and Date|0811014626/03/04/2025| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Case No.	94 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	PRIGIV SPECIALTIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000080AM26
RA File Number	03AX04006649 AM25
Licence No and<br>Date	0311042828/03/04/2025
Norms Committee Decision:<br>The firm was granted an Advance Authorisation for the export product_“Luzerny Butyrate”_under<br>Para 4.07 of the Handbook of Procedures (HBP). However, as per Para 4.11(b) of the Foreign<br>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<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.<br>	95 / NC/3/MEET/Dec/202526/11
Case Status<br>	Case Rejected
Party Name<br>	PRIGIV SPECIALTIES PRIVATE LIMITED
Meeting Number<br>and Date<br>	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number<br>	HQRNORM APPLY 00000081AM26
RA File Number<br>	03AX04006648 AM25
Licence No and<br>Date<br>	0311042829/03/04/2025
Norms Committee Decision:<br>The firm was granted an Advance Authorisation for the export product_“Luzerny Benzoate”_

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

under Para 4.07 of the Handbook of Procedures (HBP). However, as per Para 4.11(b) of the Foreign Trade Policy (FTP) 2023, products falling under the category of perfume or perfumery compounds are ineligible for authorisation under Para 4.07 and are mandatorily required to be processed under Para 4.06 of the HBP.

2023, products falling under the category of perfume or perfumery compounds are ineligible for authorisation under Para 4.07 and are mandatorily required to be processed under Para 4.06 of the HBP.

The RA concerned may take further necessary action in line with the above decision of the

Case No.	96 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	RUBICON RESEARCH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000084AM26
RA File Number	03AX04006667 AM25
Licence No and<br>Date	0311042834/03/04/2025

|Meeting Number and Date|NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025| |HQ File Number|HQRNORM APPLY 00000084AM26| |RA File Number|03AX04006667 AM25| |Licence No and Date|0311042834/03/04/2025| |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:- Copy of Drug Manufacturing Licence (DML) showing approved composition for each export item. 1. Copy of Master-Batch Formula for each export item showing net content of each input. 2.||

Case No.	97 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	VINDHYA ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

|NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

HQ File Number	HQRNORM APPLY 00000085AM26
RA File Number	09AX04001193 AM25
Licence No and<br>Date	0911009362/03/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>2-AZABICYCLO (2.2.1) HEPT-5-<br>EN-3-ONE (VINCELACTAM)<br>1.18 kg.<br>2<br>SODIUM<br>BOROHYDRIDE<br>POWDER<br>0.214 kg.<br>3<br>D(-) TARTARIC ACID<br>0.742 kg.<br>Amino Carbinol Tartrate<br>1 kg.<br>4<br>L + TARTARIC ACID<br>0.90 kg.<br>RA concerned may take further necessary action as per above decision of NC.

. 3 D(-) TARTARIC ACID 0.742 kg. Amino Carbinol Tartrate 1 kg. 4 L + TARTARIC ACID 0.90 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	98 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	ZENTIVA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000110AM26
RA File Number	03AX04000032 AM26
Licence No and<br>Date	0311042878/05/04/2025
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<br>authorization No. 0311037559 dated 01/10/2024, it was decided to fix ad-hoc norms under Para 4.07 of

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

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

Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

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.<br>allowed.
Co-codamol 8/500 tablets (Codeine<br>Phosphate Hemihydrate 8 mg and<br>Paracetamol 500mg) (Each Tablet contains<br>Codeine Phosphate Hemihydrate 8 mg and<br>Paracetamol 500 mg (Net Wt. Codeine<br>Phosphate Hemihydrate 768.00 KGS))	1 Number	1	Codeine Phosphate<br>Hemihydrate	8.16 mg.
Co-codamol 15/500 tablets (Codeine<br>Phosphate Hemihydrate 15 mg and<br>Paracetamol 500 mg) (Each Tablet<br>containsCodeine Phosphate Hemihydrate<br>15mg and Paracetamol 500 mg (Net Wt.<br>Codeine Phosphate Hemihydrate 1353.60<br>KGS))	1 Number	2	Codeine Phosphate<br>Hemihydrate	15.30 mg.
Co-codamol 30/500 tablets (Codeine<br>Phosphate Hemihydrate 30 mg and<br>Paracetamol 500 mg) (Each Tablet contains<br>Codeine Phosphate Hemihydrate 30mg and<br>Paracetamol 500 mg (Net Wt. Codeine<br>Phosphate Hemihydrate 2707.20 KGS))	1 Number	3	Codeine Phosphate<br>Hemihydrate	30.60 mg.

Case No.	99 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	ZENTIVA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000111AM26
RA File Number	03AX04000038 AM26
Licence No and	0311042879/05/04/2025

l Hydrochloride USP|10.2 mg.| ||Amlodipine and Benazepril Hydrochloride Capsules USP 05 mg / 10 mg (Pack size:500s) (Consists of 14 Kgs of||1 Number|3|Benazepril Hydrochloride USP|10.2 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

|Benazepril Hydrochloride USP Amlodipine and Benazepril Hydrochloride Capsules USP 05 mg / 20 mg (Pack size:100s) (Consists of 224 Kgs of Benazepril Hydrochloride USP 1 Number 4 Benazepril Hydrochloride USP 20.4 mg., Amlodipine and Benazepril Hydrochloride Capsules USP 05 mg / 20 mg (Pack size:500s) (Consists of 28 Kgs of Benazepril Hydrochloride USP 1 Number 5 Benazepril Hydrochloride USP 20.4 mg. Amlodipine and Benazepril Hydrochloride Capsules USP 05 mg / 40 mg (Pack size:100s) (Consists of 168 Kgs of Benazepril Hydrochloride USP 1 Number 6 Benazepril Hydrochloride USP 40.8 mg. Amlodipine and Benazepril Hydrochloride Capsules USP 10 mg / 20 mg (Pack size:100s) (Consists of 168 Kgs of Benazepril Hydrochloride USP 1 Number 7 Benazepril Hydrochloride USP 20.4 mg Amlodipine and Benazepril Hydrochloride Capsules USP 10 mg / 20 mg (Pack size:500s) (Consists of 28 Kgs of Benazepril Hydrochloride USP 1 Number 8 Benazepril Hydrochloride USP 20.4 mg. Amlodipine and Benazepril Hydrochloride Capsules USP 10 mg / 40 mg (Pack size:100s) (Consists of 336 Kgs of Benazepril Hydrochloride USP 1 Number 9

Benazepril Hydrochloride USP
Amlodipine and Benazepril Hydrochloride<br>Capsules USP 05 mg / 20 mg (Pack<br>size:100s) (Consists of 224 Kgs of<br>Benazepril<br>Hydrochloride USP	1 Number	4	Benazepril Hydrochloride USP	20.4 mg.,
Amlodipine and Benazepril Hydrochloride<br>Capsules USP 05 mg / 20 mg (Pack<br>size:500s) (Consists of 28 Kgs of<br>Benazepril Hydrochloride USP	1 Number	5	Benazepril Hydrochloride USP	20.4 mg.
Amlodipine and Benazepril Hydrochloride<br>Capsules USP 05 mg / 40 mg (Pack<br>size:100s) (Consists of 168 Kgs of<br>Benazepril Hydrochloride USP	1 Number	6	Benazepril Hydrochloride USP	40.8 mg.
Amlodipine and Benazepril Hydrochloride<br>Capsules USP 10 mg / 20 mg (Pack<br>size:100s) (Consists of 168 Kgs of<br>Benazepril Hydrochloride USP	1 Number	7	Benazepril Hydrochloride USP	20.4 mg
Amlodipine and Benazepril Hydrochloride<br>Capsules USP 10 mg / 20 mg (Pack<br>size:500s) (Consists of 28 Kgs of<br>Benazepril Hydrochloride USP	1 Number	8	Benazepril Hydrochloride USP	20.4 mg.
Amlodipine and Benazepril Hydrochloride<br>Capsules USP 10 mg / 40 mg (Pack<br>size:100s) (Consists of 336 Kgs of<br>Benazepril Hydrochloride USP	1 Number	9	Benazepril Hydrochloride USP	40.8 mg

Case No.	102 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

and Date
HQ File Number	HQRNORM APPLY 00000133AM26
RA File Number	09AX04001145 AM25
Licence No and<br>Date	0911009401/08/04/2025
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	Case No.	103 / NC/3/MEET/Dec/202526/11	103 / NC/3/MEET/Dec/202526/11	103 / NC/3/MEET/Dec/202526/11	103 / NC/3/MEET/Dec/202526/11	103 / NC/3/MEET/Dec/202526/11
Case Status		Case Approved
Party Name		PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number		HQRNORM APPLY 00000143AM26
RA File Number		03AX04000078 AM26
Licence No and<br>Date		0311042932/08/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

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. Vibegron (Gemtesa)Tablets 75 mg 1 Number 1 Vibegron 76.50 mg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Vibegron (Gemtesa)Tablets 75 mg||1 Number|1|Vibegron|76.50 mg.| ||RA concerned may take further necessary action as per above decision of NC.||||||

Case No.	104 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000144AM26

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

RA File Number

03AX04000076 AM26

Licence No and Date

0311042933/08/04/2025

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. Vibegron (Gemtesa)Tablets 75 mg 1 Number 1 Vibegron 76.50 mg. RA concerned may take further necessary action as per above decision of NC.

o. Import Items** Qty. allowed. Vibegron (Gemtesa)Tablets 75 mg 1 Number 1 Vibegron 76.50 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	105 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000145AM26
RA File Number	03AX04000077 AM26
Licence No and<br>Date	0311042934/08/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Vibegron (Gemtesa)Tablets 75 mg<br>1 Number<br>1<br>Vibegron<br>76.50 mg.<br>RA concerned may take further necessary action as per above decision of NC.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

cessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Case No.	106 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000151AM26
RA File Number	08AX04000031 AM26
Licence No and<br>Date	0811014671/08/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Ceftriaxone and Sulbactam for<br>Injection 1.5 gm<br>1 Number<br>1<br>Ceftriaxone Sodium Sterile<br>USP<br>1.16 gm.<br>Ceftriaxone and Sulbactam for<br>Injection 1.5 gm<br>1 Number<br>2<br>Ceftriaxone Sodium Sterile<br>USP<br>1.16 gm.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	107 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000158AM26
RA File Number	03AX04000099 AM26
Licence No and<br>Date	0311042949/09/04/2025
Norms Committee Decision:

3/ MEET/ Dec/ 202526/ 11 and 18/12/2025| |HQ File Number|HQRNORM APPLY 00000158AM26| |RA File Number|03AX04000099 AM26| |Licence No and Date|0311042949/09/04/2025| |Norms Committee Decision:||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

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. 0811013104 dated 29/10/2024, 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.
Indapamide Tablets BP 2.5 mg, Each<br>Firm Coated Tablet contains 2.5mg<br>(Total 3999990 Tablets) (Net Content<br>Bulk Drug Indapamide EP 10.00 kgs ))	1 Number	1	Indapamide EP	2.55 mg/Tablet

Case No.	Case No.	108 / NC/3/MEET/Dec/202526/11	108 / NC/3/MEET/Dec/202526/11	108 / NC/3/MEET/Dec/202526/11	108 / NC/3/MEET/Dec/202526/11	108 / NC/3/MEET/Dec/202526/11
Case Status		Case Approved
Party Name		AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number		HQRNORM APPLY 00000166AM26
RA File Number		09AX04001144 AM25
Licence No and<br>Date		0911009404/09/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>4-Fluoro Benzaldehyde<br>3.18 kg.<br>2<br>Propionic Anhydride<br>3.15 kg.<br>Sulindac<br>1 kg.
	Export Product<br>		Qty.	Sl. No.<br>	Import Items	Qty. allowed.
	Sulindac		1 kg.	1<br>	4-Fluoro Benzaldehyde	3.18 kg.
				2<br>	Propionic Anhydride	3.15 kg.

1 kg.||||||| ||Export Product ||Qty.|Sl. No. |Import Items|Qty. allowed.| ||Sulindac||1 kg.|1 |4-Fluoro Benzaldehyde|3.18 kg.| |||||2 |Propionic Anhydride|3.15 kg.|

Case No.	Case No.	108 / NC/3/MEET/Dec/202526/11	108 / NC/3/MEET/Dec/202526/11	108 / NC/3/MEET/Dec/202526/11	108 / NC/3/MEET/Dec/202526/11	108 / NC/3/MEET/Dec/202526/11
Case Status		Case Approved
Party Name		AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number		HQRNORM APPLY 00000166AM26
RA File Number		09AX04001144 AM25
Licence No and<br>Date		0911009404/09/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>4-Fluoro Benzaldehyde<br>3.18 kg.<br>2<br>Propionic Anhydride<br>3.15 kg.<br>Sulindac<br>1 kg.
	Export Product<br>		Qty.	Sl. No.<br>	Import Items	Qty. allowed.
	Sulindac		1 kg.	1<br>	4-Fluoro Benzaldehyde	3.18 kg.
				2<br>	Propionic Anhydride	3.15 kg.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

kg.| |||||2 |Propionic Anhydride|3.15 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

3<br>	Sodium Propionate	2.32 kg.
4<br>	Methanol	3.14 kg.
5<br>	Acetic acid	5.71 kg.
6<br>	Cyano Acetic acid	1.16 kg.

Case No.	109 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000171AM26
RA File Number	07AX04000046 AM26
Licence No and<br>Date	0711014148/09/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same<br>export product/import item in meeting No. NC/3/MEET/Jul/202526/6 dated 31/07/2025 against advance<br>authorization No.0711013156 dated 26/12/2024, 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:-<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. Premix of Nifuroxazide (1 gm of Premix contains 0.552 gm of Nifuroxazide) 6300 kg. 1 Nifuroxazide BP/EP 3512.376 kg. RA concerned may take further necessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Case No.	110 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	HONOUR LAB LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000173AM26
RA File Number	09AX04001119 AM25
Licence No and<br>Date	0911009407/09/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Ethyl 5-acetoxy-6-bromo-2-<br>(bromomethyl)-1-methyl-1H-indole-3-<br>carboxylate<br>1.910 kg.<br>Umifenovir<br>Hydrochloride<br>Monohydrate<br>(Diloxanide<br>furoate,<br>Cimetidine,<br>Oxyclozanide)<br>1 kg.<br>2<br>Thiophenol<br>0.612 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Monohydrate (Diloxanide furoate, Cimetidine, Oxyclozanide) 1 kg. 2 Thiophenol 0.612 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	111 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	HONOUR LAB LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000174AM26
RA File Number	09AX04001120 AM25
Licence No and<br>Date	0911009408/09/04/2025
Norms Committee Decision:

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

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.I	mport Items	Qty. allowed.
Ticagrelor<br>(Diloxanide<br>furoate,<br>Cimetidine<br>Oxyclozanide)	<br>,<br>1 kg.	1<br><br> <br>	4,6-dichloro-2-(propylsulfanyl)-5-<br>pyrimidiamine (Heterocyclic compounds<br>with nitrogen hetero-atom(s) only)	0.70 kg.
		2<br> <br> <br>[<br>	2-[((3aR,4S,6R,6aS)-6-amino-2,2-<br>dimethyltetrahydro-3aH-cyclopenta [d]<br>l,3]dioxol-4-yl)oxy]-l-ethanol L-tartaric<br>acid salt	1.07 kg.
		3<br>(<br> <br>(	lR,2S)-2-(3,4-difluorophenyl)<br>cyclopropan-l-amine hydrochloride<br>Amine- function compounds)	0.58 kg.

l,3]dioxol-4-yl)oxy]-l-ethanol L-tartaric acid salt|1.07 kg.| |||3 ( (|lR,2S)-2-(3,4-difluorophenyl) cyclopropan-l-amine hydrochloride Amine- function compounds)|0.58 kg.|

Case No.	112 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	LEE PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000186AM26
RA File Number	09AX04001209 AM25
Licence No and<br>Date	0911009410/09/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>7,8,9,10-Tetrahydro-6,10-<br>methano-6H-pyrazino[2,3-h]<br>[3]benzazepine<br>1 kg.<br>1<br>2,3,4,5-Tetrahydro-3-<br>(trifluoroacetyl)-1,5-methano-1H-<br>3-benzazepine<br>3.85 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Export Product<br>	Qty.	Sl. No.<br>	Import Items	Qty. allowed.
	7,8,9,10-Tetrahydro-6,10-<br>methano-6H-pyrazino[2,3-h]<br>[3]benzazepine	1 kg.	1<br><br><br>	2,3,4,5-Tetrahydro-3-<br>(trifluoroacetyl)-1,5-methano-1H-<br>3-benzazepine	3.85 kg.

|---|---|---| ||7,8,9,10-Tetrahydro-6,10- methano-6H-pyrazino[2,3-h] [3]benzazepine|1 kg.|1 |2,3,4,5-Tetrahydro-3- (trifluoroacetyl)-1,5-methano-1H- 3-benzazepine|3.85 kg.|

Case No.	113 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	LEE PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000187AM26
RA File Number	09AX04001208 AM25
Licence No and<br>Date	0911009411/09/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>7,8,9,10-Tetrahydro-6,10-<br>methano-6H-pyrazino[2,3-h]<br>[3]benzazepine<br>1 kg.<br>1<br>2,3,4,5-Tetrahydro-3-<br>(trifluoroacetyl)-1,5-methano-1H-<br>3-benzazepine<br>3.85 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 114 / NC/3/MEET/Dec/202526/11

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

C.||

Case No. 114 / NC/3/MEET/Dec/202526/11

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Case Status	Case Approved
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000210AM26
RA File Number	09AX04001188 AM25
Licence No and<br>Date	0911009414/11/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No.NC/3/MEET/Sep/202526/8 dated 17/09/2025 against advance<br>authorization No. 0911008287 dated 29/10/2024, 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:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Diluted Everolimus 5%<br>1 kg.<br>1<br>Everolimus (Spec-1)<br>0.051 kg.<br>RA concerned may take further necessary action as per above decision of NC.

No. Import Items** Qty. allowed. Diluted Everolimus 5% 1 kg. 1 Everolimus (Spec-1) 0.051 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	115 / NC/3/MEET/Dec/202526/11	115 / NC/3/MEET/Dec/202526/11	115 / NC/3/MEET/Dec/202526/11	115 / NC/3/MEET/Dec/202526/11	115 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000215AM26
RA File Number	03AX04000098 AM26
Licence No and<br>Date	0311043017/12/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.
		Qty.	Sl. No. I	mport Items	Qty. allowed.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

. No. I **|mport Items|Qty. allowed.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Azithromycin tablets 500MG, (TOTAL<br>199998 TABLETS) (Net Content Bulk<br>Drug Azithromycin Monohydrate 100<br>Kgs)<br>100 kg.<br>1<br>Azithromycin Monohydrate<br>102 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Azithromycin tablets 500MG, (TOTAL<br>199998 TABLETS) (Net Content Bulk<br>Drug Azithromycin Monohydrate 100<br>Kgs)	100 kg.	1<br>	Azithromycin Monohydrate	102 kg.

Case No.	116 / NC/3/MEET/Dec/202526/11	116 / NC/3/MEET/Dec/202526/11	116 / NC/3/MEET/Dec/202526/11	116 / NC/3/MEET/Dec/202526/11	116 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000225AM26
RA File Number	03AX04000146 AM26
Licence No and<br>Date	0311043033/15/04/2025
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/Jul/202526/6 dated 31/07/2025 against advance authorization No.<br>0311041469 dated 18/02/2025 , 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.

d 18/02/2025 , 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 Tylosin Tartrate BP/USP /EP 0.101 kg. TYLODOX GOLD WSP (Pack size 1 Kgs Jar) (Each gram contains: Tylosin Tartrate BP (Vet) 100 mg, Doxycycline Hyclate BP 200 mg) 1 Number 3 Doxycycline Hyclate BP/EP/USP 0.202 kg. 2 Tylosin Tartrate BP/USP /EP 10.1 gm. TYLODOX GOLD WSP (Pack size 100 Gms sachet) (Each gram contains: Tylosin Tartrate BP (Vet) 100 mg, Doxycycline Hyclate BP 200 mg) 1 Number 4 Doxycycline Hyclate BP/EP/USP 20.2 gm.|||||| |||Qty.|Sl. No.|Import Items|Qty. allowed.| |||1 Number|1|Tylosin Tartrate BP/USP /EP|0.101 kg.| ||||3|Doxycycline Hyclate BP/EP/USP|0.202 kg.| |||1 Number|2|Tylosin Tartrate BP/USP /EP|10.1 gm.| ||||4|Doxycycline Hyclate BP/EP/USP|20.2 gm.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

|4|Doxycycline Hyclate BP/EP/USP|20.2 gm.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

|GENTADOX GOLD 100 / 200 ( pack Size 1 Kgs Jar) (Each gram powder contains: Doxycycline Hyclate BP 200 mg, Gentamycin Sulphate USP 100 mg) 1 Number 5 Doxycycline Hyclate BP/EP/USP 0.202 kg. GENTADOX GOLD 100 /200 ( pack Size 100 Gms Sachet) (Each gram powder contains: Doxycycline Hyclate BP 200 mg, Gentamycin Sulphate USP 100 mg) 1 Number 6 Doxycycline Hyclate BP/EP/USP 20.2 gm. NEODOX GOLD WSP (pack Size 1 Kgs Jar)(Each gram contains: Doxycycline Hyclate BP 100 mg Neomycin Sulfate BP 100 mg) 1 Number 7 Doxycycline Hyclate BP/EP/USP 0.101 kg. NEODOX -GOLD WSP (pack Size 100 Gms Sachet) (Each gram contains: Doxycycline Hyclate BP 100 mg Neomycin Sulfate BP 100 mg) 1 Number 8 Doxycycline Hyclate BP/EP/USP 10.1 gm. RA concerned may take further necessary action as per above decision of NC.|GENTADOX GOLD 100 / 200 ( pack Size 1 Kgs Jar) (Each gram powder contains: Doxycycline Hyclate BP 200 mg, Gentamycin Sulphate USP 100 mg) GENTADOX GOLD 100 /200 ( pack Size 100 Gms Sachet) (Each gram powder contains: Doxycycline Hyclate BP 200 mg, Gentamycin Sulphate USP 100 mg) NEODOX GOLD WSP (pack Size 1 Kgs Jar)(Each gram contains: Doxycycline Hyclate BP 100 mg Neomycin Sulfate BP 100 mg) NEODOX -GOLD WSP (pack Size 100 Gms Sachet) (Each gram cont

00 mg) NEODOX GOLD WSP (pack Size 1 Kgs Jar)(Each gram contains: Doxycycline Hyclate BP 100 mg Neomycin Sulfate BP 100 mg) NEODOX -GOLD WSP (pack Size 100 Gms Sachet) (Each gram contains: Doxycycline Hyclate BP 100 mg Neomycin Sulfate BP 100 mg)| 1 Number|5|Doxycycline Hyclate BP/EP/USP|0.202 kg.| |---|---|---|---|---|---| ||| 1 Number|6|Doxycycline Hyclate BP/EP/USP|20.2 gm.| |||1 Number|7|Doxycycline Hyclate BP/EP/USP|0.101 kg.| |||1 Number|8|Doxycycline Hyclate BP/EP/USP|10.1 gm.|

Case No.	Case No.	117 / NC/3/MEET/Dec/202526/11	117 / NC/3/MEET/Dec/202526/11	117 / NC/3/MEET/Dec/202526/11	117 / NC/3/MEET/Dec/202526/11	117 / NC/3/MEET/Dec/202526/11
Case Status		Case Approved
Party Name		HONOUR LAB LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number		HQRNORM APPLY 00000226AM26
RA File Number		09AX04001211 AM25
Licence No and<br>Date		0911009422/15/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.Import Items<br>Qty. allowed.
	Export Product<br>		Qty.	Sl. No.	Import Items	Qty. allowed.

irm, whichever is less:- Export Product Qty. Sl. No.Import Items Qty. allowed.||||||| ||Export Product ||Qty.|Sl. No.|Import Items|Qty. allowed.|

Case No.	Case No.	117 / NC/3/MEET/Dec/202526/11	117 / NC/3/MEET/Dec/202526/11	117 / NC/3/MEET/Dec/202526/11	117 / NC/3/MEET/Dec/202526/11	117 / NC/3/MEET/Dec/202526/11
Case Status		Case Approved
Party Name		HONOUR LAB LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number		HQRNORM APPLY 00000226AM26
RA File Number		09AX04001211 AM25
Licence No and<br>Date		0911009422/15/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.Import Items<br>Qty. allowed.
	Export Product<br>		Qty.	Sl. No.	Import Items	Qty. allowed.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Ethyl-(2R,4S)-5-([1,1-biphenyl]-4-yl)-4-	1	kg.	1	(2R,4S)-5-([1,1-biphenyl]-4-yl)-4-	1.21 kg.
amino-2-methylpentanoate				((tert-butoxycarbonyl) amino)-2-
hydrochloride				methylpentanoic acid

l]-4-yl)-4-	1	kg.	1	(2R,4S)-5-([1,1-biphenyl]-4-yl)-4-	1.21 kg.
amino-2-methylpentanoate				((tert-butoxycarbonyl) amino)-2-
hydrochloride				methylpentanoic acid

Case No.	118 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000228AM26
RA File Number	03AX04000116 AM26
Licence No and<br>Date	0311043050/15/04/2025
Norms Committee Decision:<br>The firm was granted an Advance Authorisation for the export product_“HEXYL SALICYLATE”_<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<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.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Case No.	119 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	DECCAN NUTRACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000231AM26
RA File Number	02AX04000021 AM26
Licence No and<br>Date	0211008522/15/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Naltrexone<br>Hydrochloride<br>USP/PH.EUR<br>1 kg.<br>1<br>Noroxymorphone Base<br>1.03 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Qty. allowed. Naltrexone Hydrochloride USP/PH.EUR 1 kg. 1 Noroxymorphone Base 1.03 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.<br>	Case No.<br>	120 / NC/3/MEET/Dec/202526/11	120 / NC/3/MEET/Dec/202526/11	120 / NC/3/MEET/Dec/202526/11	120 / NC/3/MEET/Dec/202526/11	120 / NC/3/MEET/Dec/202526/11
Case Status<br>		Case Approved
Party Name<br>		JUBILANT GENERICS LIMITED
Meeting Number<br>and Date<br>		NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number<br>		HQRNORM APPLY 00000235AM26
RA File Number<br>		05AX04000079 AM26
Licence No and<br>Date<br>		0511031904/15/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.|

Case No.<br>	Case No.<br>	120 / NC/3/MEET/Dec/202526/11	120 / NC/3/MEET/Dec/202526/11	120 / NC/3/MEET/Dec/202526/11	120 / NC/3/MEET/Dec/202526/11	120 / NC/3/MEET/Dec/202526/11
Case Status<br>		Case Approved
Party Name<br>		JUBILANT GENERICS LIMITED
Meeting Number<br>and Date<br>		NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number<br>		HQRNORM APPLY 00000235AM26
RA File Number<br>		05AX04000079 AM26
Licence No and<br>Date<br>		0511031904/15/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

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

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Prochlorperazine Maleate Tablets<br>USP 5mg<br>1 Number<br>1<br>Prochlorperazine<br>Maleate USP<br>5.10 mg/Tablet<br>Prochlorperazine Maleate Tablets<br>USP 10mg<br>1 Number<br>2<br>Prochlorperazine<br>Maleate USP<br>10.20 mg./Tablet<br>RA concerned may take further necessary action as per above decision of NC.	Prochlorperazine Maleate Tablets<br>USP 5mg	<br>1 Number	1<br> <br>	Prochlorperazine<br>Maleate USP	5.10 mg/Tablet
	Prochlorperazine Maleate Tablets<br>USP 10mg	<br>1 Number	2<br> <br>	Prochlorperazine<br>Maleate USP	10.20 mg./Tablet

Case No.	121 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	ATUL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000244AM26
RA File Number	08AX04000041 AM26
Licence No and<br>Date	0811014718/15/04/2025
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

26| |RA File Number|08AX04000041 AM26| |Licence No and Date|0811014718/15/04/2025| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	122 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	JUBILANT GENERICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000246AM26
RA File Number	05AX04000096 AM26
Licence No and<br>Date	0511031914/16/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

|Export Product Qty. Sl. No. Import Items **Qty.

me: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

|Export Product Qty. Sl. No. Import Items Qty. allowed. Terazosin Capsules USP 1mg ((Net Content of Terazosin Hydrochloride Anhydrous 1 mg to be utilized 9.1 kgs)) 1 Number 1 Terazosin Hydrochloride Anhydrous 1.116 mg. Terazosin Capsules USP 2 mg ((Net Content of Terazosin Hydrochloride Anhydrous 2 mg to be utilized 19 kgs)) 1 Number 2 Terazosin Hydrochloride Anhydrous 2.232 mg. Terazosin Capsules USP 5 mg ((Net Content of Terazosin Hydrochloride Anhydrous 5 mg to be utilized 47.5 kgs)) 1 Number 3 Terazosin Hydrochloride Anhydrous 5.581 mg. Terazosin Capsules USP 10 mg ((Net Content of Terazosin Hydrochloride Anhydrous 10 mg to be utilized 86 kgs)) 1 Number 4 Terazosin Hydrochloride Anhydrous 11.16 mg. RA concerned may take further necessary action as per above decision of NC.|Export Product |Qty.|Sl. No.|Import Items|**Qty.

Export Product<br>	Qty.	Sl. No.	Import Items	Qty. allowed.
Terazosin Capsules USP 1mg ((Ne<br>Content of Terazosin Hydrochloride<br>Anhydrous 1 mg to be utilized 9.1 kgs))	t<br> <br>1 Number	1<br> <br>	Terazosin Hydrochloride<br>Anhydrous	1.116 mg.
Terazosin Capsules USP 2 mg ((Ne<br>Content of Terazosin Hydrochloride<br>Anhydrous 2 mg to be utilized 19 kgs))	t<br> <br>1 Number	2<br> <br>	Terazosin Hydrochloride<br>Anhydrous	2.232 mg.
Terazosin Capsules USP 5 mg ((Ne<br>Content of Terazosin Hydrochloride<br>Anhydrous 5 mg to be utilized 47.5<br>kgs))	t<br> <br> <br>1 Number	3<br> <br>	Terazosin Hydrochloride<br>Anhydrous	5.581 mg.
Terazosin Capsules USP 10 mg ((Ne<br>Content of Terazosin Hydrochloride<br>Anhydrous 10 mg to be utilized 86<br>kgs))	t<br> <br> <br>1 Number	4<br> <br>	Terazosin Hydrochloride<br>Anhydrous	11.16 mg.

Case No.	Case No.	123 / NC/3/MEET/Dec/202526/11	123 / NC/3/MEET/Dec/202526/11	123 / NC/3/MEET/Dec/202526/11	123 / NC/3/MEET/Dec/202526/11	123 / NC/3/MEET/Dec/202526/11
Case Status		Case Approved
Party Name		SRF LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number		HQRNORM APPLY 00000277AM26
RA File Number		05AX04004156 AM25
Licence No and Date		0511031944/16/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Sl.<br>Qty.<br>Export Product<br>Qty.<br>Import Items
	Export Product<br>		Qty.	Sl.<br>	Import Items	Qty.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Qty.**|Sl. |Import Items|Qty.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

No.<br>allowed.<br>1<br>3-AMINOBENZOTRIFLUORIDE<br>0.880 kg.<br>2-BROMO-5-<br>FLUOROBENZOTRIFLUORIDE<br>(BFBTF)<br>1 kg.<br>2<br>LIQUID BROMINE<br>0.445 kg.<br>RA concerned may take further necessary action as per above decision of NC.	2-BROMO-5-<br>FLUOROBENZOTRIFLUORIDE<br>(BFBTF)		No.		allowed.
		1 kg.	1<br>	3-AMINOBENZOTRIFLUORIDE	0.880 kg.
			2<br>	LIQUID BROMINE	0.445 kg.

Case No.	124 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000280AM26
RA File Number	34AX04001073 AM25
Licence No and<br>Date	3411006226/16/04/2025
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

26| |RA File Number|34AX04001073 AM25| |Licence No and Date|3411006226/16/04/2025| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||



C	ase No.		125 / NC/3/MEET/Dec/202526/11
C	ase Status		Case Deferred
P	arty Name		NATURAL AND ESSENTIAL OILS PRIVATE LIMIT	ED
M<br>an	eeting Numb<br>d Date	er	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025

H	Q File Numb	er	HQRNORM APPLY 00000320AM26
R	A File Numb	er	07AX04000087 AM26
L<br>D
	icence No an<br>ate	d	0711014206/17/04/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Complete Certificate of Analysis (CoA) of import item from foreign supplier.<br>1.	orms Commi	ttee Decision:
	he commit<br>E, it was d	tee considered the request of firm for fixation of ad-h<br>ecided to call for following information/documents from		oc norms and as per the advice of the<br>the firm:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Certificate of Analysis of all export items indicating percentage active content.
Percentage wastage claimed.
Details of by-product obtained with commercial value.

Complete material balance between import and export.

export items indicating percentage active content.

Percentage wastage claimed.
Details of by-product obtained with commercial value.

Complete material balance between import and export.

Case No.	Case No.	Case No.	126 / NC/3/MEET/Dec/202526/11	126 / NC/3/MEET/Dec/202526/11	126 / NC/3/MEET/Dec/202526/11
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number
<br>and Date			NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number			HQRNORM APPLY 00000322AM26
RA File Number			03AX04000224 AM26
Licence No and<br>Date			0311043154/18/04/2025
Norms Committee			Decision:

The Committee<br>information prov			considered the request of firm for fixation of ad-hoc norms and on the<br>ided by the firm, it was decided to fix ad-hoc norms as under:-		basis of

	Sl. No.	Export Product<br>		Quantity
	1	Medical Ointment & cream ("Hydrocortisone 1 Percentage OTC Cream1 OZ/28 gm Tube<br>(Tot Wt:840 Kg Net Cont: (In KGs) Hydro:8.40, Glyceryl 16.80,Wax 25.20, Stearyl 8.40,<br>		<br> <br>1 Number
		Isopropyl 67.20, Cety 25.20, Sorbitan 25.20, Polysorb 25.20, Anhydrous 0.59, Sodium<br>1.01, Sorbic 0.42, polyoxyl 4.2))

	2	Medic<br>	al Ointment & cream (Hydrocortisone 1 Percentage OTC Ointment 1 OZ/ 28 gm<br>	<br> <br>1 Number
		Tube<br>	Tot Wt 4840.02 Kgs Net Cont: (In Kgs) Hydrocortisone USP (Micronized)<br>
		48.40	gs))

	3	Medic	al Ointment & cream (Hydrocortisone Aloe 1% Cream 1 OZ/28 gm Tube (Tot Wt	<br>1 Number

ot Wt 4840.02 Kgs Net Cont: (In Kgs) Hydrocortisone USP (Micronized) ||| |||48.40|gs))||| ||||||| ||3|Medic|al Ointment & cream (Hydrocortisone Aloe 1% Cream 1 OZ/28 gm Tube (Tot Wt| 1 Number|| |||1540K|gs Nt Cont (InKG) Hydrocort 15.40 Glyceryl Stearate 30.80 White wax 46.20||| |||Steary Sodiu|l15.40 Isopropyl 123.20 Cetyl 46.20 Sorbitan 46.20 Polysorb 46.20 Anhydrous 1.08 m 1.85 sorbic acid 0.77 Polyoxy l 7.70 Aloe 1.54))||| ||||||| ||4|Medical Ointment & cream (Hydrocortisone Aloe 1% Cream 1 OZ/28 gm Tube (Tot Wt 1540 Kgs Nt Cont (In KG) Hydrocort 15.40 Glyceryl Stearate 30.80 White wax 46.20 Stearyl15.40 Isopropyl 123.20 Cetyl 46.20 Sorbitan 46.20 Polysorb 46.20 Anhydrous 1.08 Sodium 1.85 sorbic acid 0.77 Polyoxyl 7.70 Aloe 1.54))|| 1 Number|| |||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Sl. No.	Import Product	Quantity allowed.
1	Relevant Bulk Drugs	Net content in the export product plus 2% wastage.
2	Relevant Excipients	Net content in the export product plus 2% wastage.
3	Relevant Packaging Material	Relevant as per Packing Policy & General Notes.

Note:

i. The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption.

Case No.	127 / NC/3/MEET/Dec/202526/11	127 / NC/3/MEET/Dec/202526/11	127 / NC/3/MEET/Dec/202526/11	127 / NC/3/MEET/Dec/202526/11	127 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000332AM26
RA File Number	09AX04000048 AM26
Licence No and<br>Date	0911009467/19/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.Import Items<br>Qty. allowed.<br>Imipenem 500 mg + Relebactam<br>250 mg + Cilastatin 500 mg powder<br>1 Number<br>Vial<br>1<br>Relebactam monohydrate<br>276.15 mg.
		Qty.	Sl. No.	Import Items	Qty. allowed.
		<br>r<br>1 Number<br>Vial	1<br>	Relebactam monohydrate	276.15 mg.

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

for the preparation of solution for infusion

Case No.	Case No.	128 / NC/3/MEET/Dec/202526/11	128 / NC/3/MEET/Dec/202526/11	128 / NC/3/MEET/Dec/202526/11	128 / NC/3/MEET/Dec/202526/11	128 / NC/3/MEET/Dec/202526/11	128 / NC/3/MEET/Dec/202526/11	128 / NC/3/MEET/Dec/202526/11	128 / NC/3/MEET/Dec/202526/11	128 / NC/3/MEET/Dec/202526/11

Case Status		Case Approved

Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED
i
Meetng Number<br>and Date		NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025

HQ File Number		HQRNORM APPLY 00000340AM26
il
RA Fe Number		05AX04000084 AM26
i
Lcence No and<br>Date		0511031988/21/04/2025

Norms Committee		Decision:
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/May/202526/3 dated 04/06/2025 against advance<br>authorization No.0511028223 dated 10/10/2024, 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:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.

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. Brinzolamide Ophthalmic Suspension, 1% w/v 5 ml (Sterile Eye Drops) ((Each ml contains Brinzolamide 10 mg (Equivalent to 1150.000 Gm of Bulk Drug)) 1 Number 1 Brinzolamide (Micronized and Sterile) 51.00 mg/Vial Brinzolamide Ophthalmic Suspension, 1% w/v 10 ml 1 Number 2 Brinzolamide 102.00 mg/Vial||||||||||| ||Export Product|||Qty.||Sl. No.||Import Items|Qty. allowed.|| |||||||||||| ||Brinzolamide Ophthalmic|||1 Nu|mber||1 |Brinzolamide|5|1.00 mg/Vial| || Suspension, 1% w/v 5 ml (Sterile Eye Drops) ((Eac contains Brinzolamide 10 (Equivalent to 1150.000 || h ml mg Gm|||||(Micronized and Sterile)||| ||of Bulk Drug))|||||||||| ||Brinzolamide Ophthalmic Suspension, 1% w/v 10 ml|||1 Number||2 ||Brinzolamide|102.00 mg/Vial|| || (Sterile Eye Drops) ((Each ml contains Brinzolamide 10 mg (Equivalent to 1500.000 Gm|||||||(Micronized and Sterile)||| |||||||||||| ||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

zed and Sterile)||| |||||||||||| ||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

of Bulk Drug))<br>Brinzolamide Ophthalmic<br>Suspension, 1% w/v 15 ml<br>(Sterile Eye Drops)( (Each ml<br>contains Brinzolamide 10 mg<br>(Equivalent to 2250.000 Gm<br>of Bulk Drug) (Total 4900.000<br>Gm of Bulk Drug)<br>1 Number<br>3<br>Brinzolamide<br>(Micronized and Sterile)<br>153.00 mg/Vial<br>RA concerned may take further necessary action as per above decision of NC.	of Bulk Drug))
	Brinzolamide Ophthalmic<br>Suspension, 1% w/v 15 ml<br>(Sterile Eye Drops)( (Each ml<br>contains Brinzolamide 10 mg<br>(Equivalent to 2250.000 Gm<br>of Bulk Drug) (Total 4900.000<br>Gm of Bulk Drug)	1 Number	3	Brinzolamide<br>(Micronized and Sterile)	153.00 mg/Vial

Case No.	Case No.	129 / NC/3/MEET/Dec/202526/11	129 / NC/3/MEET/Dec/202526/11	129 / NC/3/MEET/Dec/202526/11	129 / NC/3/MEET/Dec/202526/11	129 / NC/3/MEET/Dec/202526/11
Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number		HQRNORM APPLY 00000345AM26
RA File Number		05AX04000073 AM26
Licence No and<br>Date		0511031999/21/04/2025
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.

0511031999/21/04/2025||||| |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/Jun/202526/5 dated 30/06/2025 against advance authorization No**.**0511029128 dated 22/11/2024, 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. Tobramycin 300 mg / 5 ml Nebuliser Solution ((Each ml contains Tobramycin Ph. Eur. 60 mg) (Equivalent to 572.880 Kg of Bulk Drug)) 1 Number Pack 1 Tobramycin 315 mg/Vial||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Tobramycin 300 mg / 5 ml Nebuliser Solution ((Each ml contains Tobramycin Ph. Eur. 60 mg) (Equivalent to 572.880 Kg of Bulk Drug))||1 Number Pack|1|Tobramycin|315 mg/Vial| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

NC also recommended for making a new SION for this export product.

me: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

NC also recommended for making a new SION for this export product.

Case No.	Case No.	Case No.	130 / NC/3/MEET/Dec/202526/11	130 / NC/3/MEET/Dec/202526/11	130 / NC/3/MEET/Dec/202526/11
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number			HQRNORM APPLY 00000373AM26
RA File Number			03AX04000242 AM26
Licence No and<br>Date			0311043189/22/04/2025
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and on the basis of<br>information provided by the firm, it was decided to fix ad-hoc norms as under:-<br>Sl. No.<br>Export Product<br>Quantity<br>1<br>Medical Ointment & Cream ("Fluorouracil Topical Solution USP 5%, 10 ml Total<br>Nt Wt. 250 Kgs (fluo12.5 Kgs, ede 0.13kgs, met 0.25, gly 119.76, para 0.08 Kgs,<br>tro21 kgs, hyd 6.25 kg, bot 25000, drop 25000, cap 25000)")<br>1 Number<br>2<br>Medical Ointment & Cream (Fluorouracil Cream USP 5% 40 Gm Total Nt<br>Wt.7200 Kgs (fluo 360 Kgs, wh petro1512 kgs, progly 864Kgs, stearyl alco1080,<br>poly 288 Kgs, pro para 1.08 kgs, methyl 1.8 Kgs))<br>1 Number<br>Sl. No.

(Fluorouracil Cream USP 5% 40 Gm Total Nt Wt.7200 Kgs (fluo 360 Kgs, wh petro1512 kgs, progly 864Kgs, stearyl alco1080, poly 288 Kgs, pro para 1.08 kgs, methyl 1.8 Kgs)) 1 Number Sl. No. Import Product Quantity allowed. 1 Relevant Bulk Drugs Net content in the export product plus 2% wastage. 2 Relevant Excipients Net content in the export product plus 2% wastage. 3 Relevant Packaging Material Relevant as per Packing Policy & General Notes.|||||| ||Sl. No.|Export Product |||Quantity| ||1|Medical Ointment & Cream ("Fluorouracil Topical Solution USP 5%, 10 ml Total Nt Wt. 250 Kgs (fluo12.5 Kgs, ede 0.13kgs, met 0.25, gly 119.76, para 0.08 Kgs, tro21 kgs, hyd 6.25 kg, bot 25000, drop 25000, cap 25000)") ||| 1 Number| ||2|Medical Ointment & Cream (Fluorouracil Cream USP 5% 40 Gm Total Nt Wt.7200 Kgs (fluo 360 Kgs, wh petro1512 kgs, progly 864Kgs, stearyl alco1080, poly 288 Kgs, pro para 1.08 kgs, methyl 1.8 Kgs))||| 1 Number| ||||||| ||Sl. No.|Import Product||Quantity allowed.|| ||1|Relevant Bulk Drugs||Net content in the export product plus 2% wastage.|| ||2|Relevant Excipients||Net content in the export product plus 2% wastage.|| ||3|Relevant Packaging Material||Relevant as per Packing Policy & General Notes.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Note:

i. The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption.

Case No.	131 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000379AM26
RA File Number	07AX04000114 AM26
Licence No and<br>Date	0711014238/22/04/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Complete chemical reaction, indicating molecular weight of reactant/s and product/s with overall yield of the<br>reaction for both the export items.<br>1.<br>Production specifically for both the export items vis-à-vis consumption of raw materials for the last three years<br>duly certified by Chartered Accountant.<br>2.<br>Copy of minutes of norms committee, if, approved in the past.<br>3.

Case No.	132 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000384AM26
RA File Number	07AX04000107 AM26
Licence No and<br>Date	0711014246/22/04/2025
Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

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/Apr/202526/1 dated 25/04/2025 against advance authorization No . 0711012278 dated 06/09/2024, 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.
Dexamethasone Sodium<br>Phosphate 1 ml. Injection<br>(Net Contents 3334 kg))	1 Number	1	Dexamethasone Sodium<br>Phosphate USP	11.76 mg/Vial

Case No.	Case No.	133 / NC/3/MEET/Dec/202526/11	133 / NC/3/MEET/Dec/202526/11	133 / NC/3/MEET/Dec/202526/11	133 / NC/3/MEET/Dec/202526/11	133 / NC/3/MEET/Dec/202526/11
Case Status		Case Approved
Party Name		MICRO LABS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number		HQRNORM APPLY 00000388AM26
RA File Number		07AX04000121 AM26
Licence No and<br>Date		0711014253/22/04/2025
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.

0711014253/22/04/2025||||| |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/Sep/202526/8 dated 17/09/2025 against advance authorization No**.**0711013517 dated 30/01/2025, 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. Ramelteon 8 mg. Tablets 1 Number Tablet 1 Ramelteon 8.16 mg/Tablet||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Ramelteon 8 mg. Tablets||1 Number Tablet|1|Ramelteon|8.16 mg/Tablet|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Case No.	134 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000389AM26
RA File Number	07AX04000106 AM26
Licence No and<br>Date	0711014254/22/04/2025
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/Oct/202526/9 dated 14/10/2025 against advance<br>authorization No.0511031098 dated 27/02/2025, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol.

port item in meeting No. NC/3/MEET/Oct/202526/9 dated 14/10/2025 against advance authorization No**.**0511031098 dated 27/02/2025, 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. Losartan Potassium 25 mg. Tablets 1 Number 1 Losartan Potassium (BP/EP/USP/IP) 25.50 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	135 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000409AM26
RA File Number	08AX04000104 AM26

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

00409AM26| |RA File Number|08AX04000104 AM26|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

Licence No and Date

0811014779/23/04/2025

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. Tranexamic Acid in 0.7% Sodium Chloride Injection 1,000 mg. per 100 mL (10 mg / mL) 1 Number 1 Tranexamic acid (Injectable grade, US FDA approved 1050 mg. /100 ml. Vial RA concerned may take further necessary action as per above decision of NC.

Case No.	136 / NC/3/MEET/Dec/202526/11
Case Status	Case Rejected
Party Name	TOJO VIKAS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000425AM26
RA File Number	05AX04000229 AM26
Licence No and<br>Date	0511032095/24/04/2025
Norms Committee Decision:<br>The firm was granted an Advance Authorisation for the export product_“Massoia Lactone”_under<br>Para 4.07 of the Handbook of Procedures (HBP).

e|0511032095/24/04/2025| |Norms Committee Decision: The firm was granted an Advance Authorisation for the export product_“Massoia Lactone”_under Para 4.07 of the Handbook of Procedures (HBP). However, as per Para 4.11(b) of the Foreign Trade Policy (FTP) 2023, products falling under the category of perfume or perfumery compounds are ineligible for authorisation under Para 4.07 and are mandatorily required to be processed under Para 4.06 of the HBP. It was observed that the firm obtained the authorisation bymisdeclaring that its application was covered under the provisions of Para 4.07, and has not furnished any technical justification/information for the export product. Accordingly, the Committee found 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||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

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.

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.	137 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000437AM26
RA File Number	09AX04000044 AM26
Licence No and<br>Date	0911009506/24/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Teriparatide Injection 560 mcg / 2.24<br>ml. (Each ml. contains Teriparatide -<br>250 mcg)<br>1 Number<br>1<br>Teriparatide ((Parathyroid<br>Hormone (1-34) Human,<br>Acetate))<br>616.0 mcg/Vial<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	138 / NC/3/MEET/Dec/202526/11
Case Status	Case Approved
Party Name	WINDLAS BIOTECH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

|NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

HQ File Number	HQRNORM APPLY 00000441AM26
RA File Number	05AX04000217 AM26
Licence No and<br>Date	0511032119/24/04/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Moxifloxacin Tablet 400 mg Pack Size<br>30 tablet in a bottle (Total 3,30,000<br>tablets in 11000 bottles)<br>1 Number<br>Tablet<br>1<br>Moxifloxacin HCL<br>408.0 mg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	139 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	ADCOCK INGRAM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025
HQ File Number	HQRNORM APPLY 00000460AM26
RA File Number	07AX04000137 AM26
Licence No and<br>Date	0711014284/25/04/2025
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	140 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	ADCOCK INGRAM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025

ts.||

Case No.	140 / NC/3/MEET/Dec/202526/11
Case Status	Case Deferred
Party Name	ADCOCK INGRAM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202526/ 11 and 18/12/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00500686AM26

HQ File Number	HQRNORM APPLY 00000461AM26
RA File Number	07AX04000136 AM26
Licence No and<br>Date	0711014285/25/04/2025
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 16-Jan-2026 18:51:03 Reason: ramankumar@nic.in Location: DGFT(HQ)

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