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

MeetingNo-NC/3/MEET/Oct/202526/9 MeetingDate-14/10/2025

Minutes of the Norms Committee–3 Meeting No.NC/3/MEET/Oct/202526/9 dated 14/10/2025 under the Chairmanship of Shri Rakesh Kumar, Addl. DGFT for considering the cases/issues under the Duty Exemption Scheme (Chapter-4) of the Foreign Trade Policy, 2023 pertaining to Chemical and Allied products falling under 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 Nand Lal, Technical Expert	Consultant (Chemical)
4	Shri Raman Kumar, Deputy DGFT	DGFT (HQ)
5	Smt. Skina Rani, FTDO	DGFT (HQ)

Signature Not Verified Signature Not Verified Digitally Signed. Digitally signa, Name: RAMAN KUMAR( Deputy Name: RAMAN KUJAMAR( Deputy DGFT ) DGFT Date: 19-Nov-2025 14:26:22 Date: )19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ) Location:Reason: ramaniagnar@nic.inDGFTTHQ)

This document has been digitally signed by Raman Kumar, Deputy DGFT,DGFT(HQ) on 19-Nov-2025.

UDIN00405997AM26

mankumar@nic.in Location: DGFT(HQ) Location:Reason: ramaniagnar@nic.inDGFTTHQ)

This document has been digitally signed by Raman Kumar, Deputy DGFT,DGFT(HQ) on 19-Nov-2025.

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

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

    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.

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/Oct/202526/9
Case Status	Case Deferred
Party Name	ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00001052AM26
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>Details of Packing Material and its requirement for export item with sample.

Case No.	2 / NC/3/MEET/Oct/202526/9
Case Status	Case Deferred
Party Name	INDO AMINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM REVIW00002408AM26
RA File Number	039404000984 AM19
Licence No and<br>Date	0310827206/21/02/2019
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>Meaning of IAL LAD in the export description.<br>1.

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

t description. 1.||

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

In Annexure to Appendix-4 E, the import item is shown as ‘liquid’ whereas in Certificate of Analysis (CoA), it is indicated as solid and same is to clarify.
Justification of 10.90% of wastage of raw material.

In Annexure to Appendix-4 E, the import item is shown as ‘liquid’ whereas in Certificate of Analysis<br>(CoA), it is indicated as solid and same is to clarify.<br>2.<br>Justification of 10.90% of wastage of raw material.<br>3.	In Annexure to Appendix-4 E, the import item is shown as ‘liquid’ whereas in Certificate of Analysis<br>(CoA), it is indicated as solid and same is to clarify.<br>2.<br>Justification of 10.90% of wastage of raw material.<br>3.	In Annexure to Appendix-4 E, the import item is shown as ‘liquid’ whereas in Certificate of Analysis<br>(CoA), it is indicated as solid and same is to clarify.<br>2.<br>Justification of 10.90% of wastage of raw material.<br>3.	In Annexure to Appendix-4 E, the import item is shown as ‘liquid’ whereas in Certificate of Analysis<br>(CoA), it is indicated as solid and same is to clarify.<br>2.<br>Justification of 10.90% of wastage of raw material.<br>3.	In Annexure to Appendix-4 E, the import item is shown as ‘liquid’ whereas in Certificate of Analysis<br>(CoA), it is indicated as solid and same is to clarify.<br>2.<br>Justification of 10.90% of wastage of raw material.<br>3.

own as ‘liquid’ whereas in Certificate of Analysis (CoA), it is indicated as solid and same is to clarify. 2. Justification of 10.90% of wastage of raw material. 3.| |---|---|---|---|---| || Just 3.|, ification of 10.90% of wastage of raw mate||y. rial.| |||||| |||||| |||||| |C|ase No.||3 / NC/3/MEET/Oct/202526/9|| |C||||| ||ase Status||Case Rejected|| |Pa|rty Name||BALAJI AMINES LIMITED|| |Meeting Number and Date|eeting Nu|mber||| ||||NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025|| |HQ File Number|||HQRNORM REVIW00003062AM26|| |RA File Number|||318304000150 AM20|| |Licence No and Date|||3110067697/25/02/2020|| |Norms Committee Decision: The Committee considered the firm’s request for a review of the ad-hoc norms. Upon examination, it was observed that the firm had not furnished any substantive technical justification or supporting information to warrant an enhancement of the existing norms. In the absence of any new material evidence or justification||||| |, the Committee found no reasonable grounds to review or revise the norms. Accordingly, it was decided to reject the request and maintain the status quo.|||||

evidence or justification||||| |, the Committee found no reasonable grounds to review or revise the norms. Accordingly, it was decided to reject the request and maintain the status quo.|||||




Case No.		4 / NC/3/MEET/Oct/202526/9
Case Status		Case Approved
Party Name		INDO AMINES LIMITED
Meeting Number		NC/ 3/ MEET/ Ot/ 202526/ 9 d 14/10/2025
and Date		c an
HQ File Number		HQRNORM REVIW00002402AM26
RA File Number		039404000141 AM21
Licence No and<br>Date		0310836585/09/06/2020
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>Sl.<br>Export Product<br>Qty.<br>Import Items<br>Qty. allowed.
	f HBP Vol. I as per details given bel		ow or as appl		ed by th	e firm, whichever is less:-
	Export Product
				Qty.	Sl.	Import Items	Qty. allowed.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

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			No.
Valeronitrile	1	Kg.	1	2-Penetenenitrile	0.996	Kg.

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

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			No.
Valeronitrile	1	Kg.	1	2-Penetenenitrile	0.996	Kg.

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

Case No.	5 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	ANUH PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006659AM25
RA File Number	NA
Licence No and<br>Date	0311000657/04/01/2021
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in the meeting No. NC/3/MEET/Jun/202526/5 dated 30.06.2025 against<br>Advance Authoristion No. 0310836875 dt. 25/06/2020 it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Deflazacort IP/BP/EP<br>1 kg.<br>1<br>11 B, 16B)-Hydroxy 2-Methly-5H-<br>Pregna-1.4Dieno<br>(17.16D) Oxazole-3.0-Dione (D5)<br>1.00 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 6 / NC/3/MEET/Oct/202526/9

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

of NC.||

Case No. 6 / NC/3/MEET/Oct/202526/9

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Case Status<br>Case Approved
Party Name<br>INDO AMINES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number<br>HQRNORM REVIW00002507AM26
RA File Number<br>03AX04005572 AM23
Licence No and<br>Date<br>0311021737/27/02/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07
of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty. allowed.
1<br>Styrenated Phenol or IAL SP<br>1 kg.	Styrene	0.584 kg.
2	Phenol	0.257 kg.
RA concerned may take further necessary action as per above decision of NC.

.|Import Items|Qty. allowed.|| |1 Styrenated Phenol or IAL SP 1 kg.|Styrene|0.584 kg.|| |2|Phenol|0.257 kg.|| |RA concerned may take further necessary action as per above decision of NC.||||

Case No.<br>7 / NC/3/MEET/Oct/202526/9
Case Status<br>Case Rejected
Party Name<br>SUPRIYA LIFESCIENCE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number<br>HQRNORM REVIW00003046AM26
RA File Number<br>03AX04001271 AM25
Licence No and<br>Date<br>0311034600/13/06/2024
Norms Committee Decision:
The Committee considered the firm’s request for a review of the ad-hoc norms. Upon examination, it was
observed that the firm had not furnished any substantive technical justification or supporting information to
warrant an enhancement of the existing norms. In the absence of any new material evidence or justification,
the Committee found no reasonable grounds to review or revise the norms. Accordingly, it was decided to
reject the request and maintain the status quo.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

ject the request and maintain the status quo.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26


Case No.		8 / NC/3/MEET/Oct/202526/9
Case Status		Case Approved
Party Name		MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number		NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
and Date

HQ File Number		HQRNORM APPLY 00005564AM25

RA File Number		03AX04004855 AM25

Licence No and<br>Date		0311040319/09/01/2025

Norms Committee		Decision:
The Committee		considered the case as per the agenda and taking cue from the earlier decision for the same
<br>export product/<br>Advance Autho		<br>import item in the meeting<br>isation No 0311040267 dt		<br>No. NC/3/MEET/Jul/202526/6 dated 31.07.2025 against<br>08/01/2025 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>5-Nitrofurfural Diacetate<br>1.13 kg.<br>Nitrofurantoin Macrocrystals<br>(Nitrofurantoin Anhydrous)<br>1 kg.<br>2<br>1-Aminohydantion HCl<br>0.59 kg.<br>RA concerned may take further necessary action as per above decision of NC.				,<br>or as applied by the firm, whichever is less:-
	Export Product		Qty.	Sl. No.	Import Items	Qty.

59 kg. RA concerned may take further necessary action as per above decision of NC.||||||, or as applied by the firm, whichever is less:-||||| |||Export Product|||Qty.|Sl. No.||Import Items|Qty. allowed.|| |||||||||||| |||Nitrofu|rantoin Macrocrystals||1 kg.|1||5-Nitrofurfural Diacetate||1.13 kg.| |||(Nitrof|urantoin Anhydrous)|||||||| |||||||2||1-Aminohydantion HCl||0.59 kg.| |||||||||||| ||A concer||ned may take further necessary action as per above decision of NC.|||||||| |||||||||||| |||||||||||| |||||||||||| |C|ase No.|||9 / NC/3/MEET/Oct/202526/9||||||| |C|ase Status|||Case Approved||||||| |P|arty Name|||AARTI PHARMALABS LIMITED||||||| |M a|eetin Nu||mber|||||||| ||g nd Date|||NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10|||/2025|||| |H|Q File Nu||mber|HQRNORM APPLY 00005550AM25||||||| |R|A File Nu||mber|03AX04004964 AM25||||||| |L D|icence No ate||and|0311040297/09/01/2025|||||||

Case No.	9 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	AARTI PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00005550AM25
RA File Number	03AX04004964 AM25
Licence No and<br>Date	0311040297/09/01/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

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.<br>allowed.
Di Ethyl Sulphate	1 kg.	1	Ethanol (Ethyl Alcohol and other Spirits<br>Denatured of any Stregnth Denatured Ethyl<br>Alcohol	0.703 kg.
		2	SO3	0.611 kg.
		3	Sodium Sulphate	0.114 kg.

Case No.	Case No.	Case No.	10 / NC/3/MEET/Oct/202526/9	10 / NC/3/MEET/Oct/202526/9
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number			HQRNORM APPLY 00006226AM25
RA File Number			03AX04005834 AM25
Licence No and<br>Date			0311041344/14/02/2025
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. Export Product<br>Quantity<br>Medical Ointments / Creams (NITROGLYCERIN OINTMENT USP 0.4% 30 G<br>(Tot net Wt 1200 Kgs Net Cont: SDM 27 (10% NITROGLYCERIN IN PROP.<br>1<br>1 Number
	Sl. No.	Export Product		Quantity
	1	Medical Ointments / Creams (NITROGLYCERIN OINTMENT USP 0.4% 30 G<br>(Tot net Wt 1200 Kgs Net Cont: SDM 27 (10% NITROGLYCERIN IN PROP.		1 Number

mber||||| ||Sl. No.|Export Product||Quantity| ||1|Medical Ointments / Creams (NITROGLYCERIN OINTMENT USP 0.4% 30 G (Tot net Wt 1200 Kgs Net Cont: SDM 27 (10% NITROGLYCERIN IN PROP.||1 Number|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

GLYCOL) 48 Kgs, Pharmalan 168 Kgs, Sorbitan 24Kgs, Aluminium Tubes 40000 Nos))

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.	Case No.	11 / NC/3/MEET/Oct/202526/9	11 / NC/3/MEET/Oct/202526/9	11 / NC/3/MEET/Oct/202526/9	11 / NC/3/MEET/Oct/202526/9	11 / NC/3/MEET/Oct/202526/9
Case Status		Case Approved
Party Name		MANKIND PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number		HQRNORM APPLY 00006236AM25
RA File Number		05AX04003948 AM25
Licence No and<br>Date		0511030908/14/02/2025
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in the meeting No. NC/3/MEET/Jun/202526/5 dated 30/06/2025 against<br>Advance Authorisatgion No.0511019756 dt. 12/07/2023, 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>Timolol<br>Maleate<br>Ophthalmic<br>51000<br>1<br>Timolol Maleate USP<br>0.884 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Timolol<br>Maleate<br>Ophthalmic		<br>51000	1	Timolol Maleate USP	0.884 kg.

c 51000 1 Timolol Maleate USP 0.884 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Timolol Maleate Ophthalmic|| 51000|1|Timolol Maleate USP|0.884 kg.|

Case No.	Case No.	11 / NC/3/MEET/Oct/202526/9	11 / NC/3/MEET/Oct/202526/9	11 / NC/3/MEET/Oct/202526/9	11 / NC/3/MEET/Oct/202526/9	11 / NC/3/MEET/Oct/202526/9
Case Status		Case Approved
Party Name		MANKIND PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number		HQRNORM APPLY 00006236AM25
RA File Number		05AX04003948 AM25
Licence No and<br>Date		0511030908/14/02/2025
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in the meeting No. NC/3/MEET/Jun/202526/5 dated 30/06/2025 against<br>Advance Authorisatgion No.0511019756 dt. 12/07/2023, 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>Timolol<br>Maleate<br>Ophthalmic<br>51000<br>1<br>Timolol Maleate USP<br>0.884 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Timolol<br>Maleate<br>Ophthalmic		<br>51000	1	Timolol Maleate USP	0.884 kg.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

ic|| 51000|1|Timolol Maleate USP|0.884 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Solution, USP 0.25% (5 ml.)	Numbers
Timolol<br>Maleate<br>Ophthalmic<br>Solution, USP 0.25% (10 ml.)	<br>20000<br>Numbers	2	Timolol Maleate USP	0.694 kg.
Timolol<br>Maleate<br>Ophthalmic<br>Solution, USP 0.5% (5 ml.)	<br>515000<br>Numbers	3	Timolol Maleate USP	17860.22 gm.
Timolol<br>Maleate<br>Ophthalmic<br>Solution, USP 0.5% (10 ml.)	<br>65000<br>Numbers	4	Timolol Maleate USP	4508.40 gm.

SP 0.5% (5 ml.)| 515000 Numbers|3|Timolol Maleate USP|17860.22 gm.| ||Timolol Maleate Ophthalmic Solution, USP 0.5% (10 ml.)| 65000 Numbers|4|Timolol Maleate USP|4508.40 gm.|

Case No.	Case No.	Case No.	12 / NC/3/MEET/Oct/202526/9	12 / NC/3/MEET/Oct/202526/9
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number			HQRNORM APPLY 00006244AM25
RA File Number			03AX04005844 AM25
Licence No and<br>Date			0311041395/16/02/2025
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. Export Product<br>Quantity<br>1<br>Medical Creams and Onitments ("Fluorouracil Topical Solution USP 5%, 10ml<br>Total Nt Wt. 645 Kgs (fluo 32.353 Kgs, ede 0.335 kgs, met 0.645, gly 308.981,<br>para 0.206 Kgs, tro54.18 kgs, hyd 16.125 kg, bot 64500, drop 64500, cap 64500)")<br>1 Number
	Sl. No.	Export Product<br>		Quantity
	1	Medical Creams and Onitments ("Fluorouracil Topical Solution USP 5%, 10ml<br>Total Nt Wt. 645 Kgs (fluo 32.353 Kgs, ede 0.335 kgs, met 0.645, gly 308.981,<br>para 0.206 Kgs, tro54.18 kgs, hyd 16.125 kg, bot 64500, drop 64500, cap 64500)")<br>		<br> <br>1 Number

%, 10ml Total Nt Wt. 645 Kgs (fluo 32.353 Kgs, ede 0.335 kgs, met 0.645, gly 308.981, para 0.206 Kgs, tro54.18 kgs, hyd 16.125 kg, bot 64500, drop 64500, cap 64500)") || 1 Number|

Case No.	Case No.	Case No.	12 / NC/3/MEET/Oct/202526/9	12 / NC/3/MEET/Oct/202526/9
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number			HQRNORM APPLY 00006244AM25
RA File Number			03AX04005844 AM25
Licence No and<br>Date			0311041395/16/02/2025
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. Export Product<br>Quantity<br>1<br>Medical Creams and Onitments ("Fluorouracil Topical Solution USP 5%, 10ml<br>Total Nt Wt. 645 Kgs (fluo 32.353 Kgs, ede 0.335 kgs, met 0.645, gly 308.981,<br>para 0.206 Kgs, tro54.18 kgs, hyd 16.125 kg, bot 64500, drop 64500, cap 64500)")<br>1 Number
	Sl. No.	Export Product<br>		Quantity
	1	Medical Creams and Onitments ("Fluorouracil Topical Solution USP 5%, 10ml<br>Total Nt Wt. 645 Kgs (fluo 32.353 Kgs, ede 0.335 kgs, met 0.645, gly 308.981,<br>para 0.206 Kgs, tro54.18 kgs, hyd 16.125 kg, bot 64500, drop 64500, cap 64500)")<br>		<br> <br>1 Number

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

op 64500, cap 64500)") || 1 Number|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

2 Medical Creams and Onitments ("Fluorouracil Cream USP 5% 40 Gm Total Nt 1 Number Wt. 8800 Kgs (fluo 440 Kgs, wh petro1848 kgs, pro gly1056 Kgs, stearyl alco 1320, poly 352 Kgs, pro para 1.32 kgs, methyl 2.200 Kgs)")

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.	Case No.	13 / NC/3/MEET/Oct/202526/9	13 / NC/3/MEET/Oct/202526/9	13 / NC/3/MEET/Oct/202526/9	13 / NC/3/MEET/Oct/202526/9	13 / NC/3/MEET/Oct/202526/9
Case Status		Case Approved
Party Name		DEEPAK NOVOCHEM SPECIALITIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number		HQRNORM APPLY 00006264AM25
RA File Number		31AX04000440 AM25
Licence No and<br>Date		3111004443/17/02/2025
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.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

1<br>Phenol<br>0.963 kg.<br>2<br>Methanol<br>0.750 kg.<br>2,6 Xylenol<br>1 kg.<br>3<br>Catalyst (Katalco)<br>0.004 kg.<br>RA concerned may take further necessary action as per above decision of NC.	2,6 Xylenol	1 kg.	1	Phenol	0.963 kg.
			2	Methanol	0.750 kg.
			3	Catalyst (Katalco)	0.004 kg.

cerned may take further necessary action as per above decision of NC.	2,6 Xylenol	1 kg.	1	Phenol	0.963 kg.
			2	Methanol	0.750 kg.
			3	Catalyst (Katalco)	0.004 kg.

Case No.	14 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM SPECIALITIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006265AM25
RA File Number	31AX04000438 AM25
Licence No and<br>Date	3111004444/17/02/2025
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.<br>Import Items<br>Qty. allowed.<br>1<br>Phenol<br>0.963 kg.<br>2<br>Methanol<br>0.750 kg.<br>2,6 Xylenol<br>1 kg.<br>3<br>Catalyst (Katalco)<br>0.004 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

cessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26




Case No.		15 / NC/3/MEET/Oct/202526/9
C Stt		C Ad
ase aus		ase pprove
Party Name		USV PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ	File Number	HQRNORM APPLY 00006259AM25
RA	File Number	03AX04005876 AM25
Lic<br>Da
	ence No and<br>te	0311041412/17/02/2025
No<br>T<br>e<br>A<br>4.	rms Committee Decision:
	he Committee considered the case as per t<br>xport product/import item in the meetin<br>dvance Authorisation No. 0311034851 d<br>07 of HBP Vol. I as per details given belo		he agenda and<br>g No. NC/3/<br>t. 24/06/2024<br>w or as applie	taking cu<br>MEET/Dec<br>, it was de<br>d by the fi	e from the earlier dec<br>/202425/12 dated 1<br>cided to fix ad-hoc<br>rm, whichever is less	ision for the same<br>0/12/2024 against<br>norms under Para<br>:-
	<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
			Qty.	Sl. No.	Import Items		Qty. allowed.
	Idezar 150 mg Tablets 28 S (Irbesartan<br>Tablets 150 mg 28 S ) ((31,000 Boxes<br>X 28 Tbl B 868000
			1 Number	1	Irbesartan Ph.

owed.||||||| ||||Qty.|Sl. No.|Import Items||Qty. allowed.| ||Idezar 150 mg Tablets 28 S (Irbesartan Tablets 150 mg 28 S ) ((31,000 Boxes X 28 Tbl B 868000||||||| ||||1 Number|1|Irbesartan Ph. Eur||153 mg.| ||aets Tablets)|per oxes = ,,|||||| ||||||||| ||(Total Weig|ht of Export Product =|||||| ||130.200 K input/materia|gs) (Exempts imported l weight inclusive of| ||||| ||wastage = 14| 0.655 Kgs))|||||| ||||||||| ||||||||| |RA concerned may take further necessary action as per above decision of NC.||||||||

Case No.	16 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

HQ File Number	HQRNORM APPLY 00006290AM25
RA File Number	34AX04000999 AM25
Licence No and<br>Date	3411006105/18/02/2025
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.

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. Betamethasone Valerate Foam 0.12% -50 gm CAN (Net content of active ingredients 1320.00 GMS) 1 Number 1 Betamethasone Valerate USP (Micronized 61.20 mg. Betamethasone Valerate Foam 0.12% -100 gm CAN (Net content of active ingredients 2640.00 GMS) 1 Number 2 Betamethasone Valerate USP (Micronized) 122.40 mg. RA concerned may take further necessary action as per above decision of NC. **Note:**The committee also decided to review SION A-3690.||

Case No.	17 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	MATRIX LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006291AM25
RA File Number	03AX04005867 AM25
Licence No and<br>Date	0311041473/18/02/2025
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in the meeting No. NC/3/MEET/Apr/202526/1 dated 25/04/2025 against<br>Advance Authorisation No. 0311037569 dt. 01/10/2024, 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:-

vance Authorisation No. 0311037569 dt. 01/10/2024, 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:-||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Sl.No.	Export Product	Quantity
1	Natural Refined Phytosterol 95%	60000 kg.
2	Natural Mixed Tocopherol 50%	38500 kg.

Sl. No.	Import Item	Quantity
1	Fatty Acid Distillate /Deoderised Distillate	9,21,250 kg.
2	Acetone	44,000 kg.
3	N Heptane	94,050 kg.

Case No.	Case No.	Case No.	18 / NC/3/MEET/Oct/202526/9
Case Status			Case Approved
Party Name			METROCHEM API PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number			HQRNORM APPLY 00006305AM25
R	A File Numbe	r	26AX04000041 AM25
L<br>D	icence No and<br>ate		2611001812/19/02/2025

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.

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. Saxagliptin intermediates (N-[2-(3- Cyano-2- Azabicyclo [3.1.0] Hexan-2- (2S)-2-(3-hydroxy-1- adamantyl)-2-[(2- 1 kg. 1 0.98 kg.|orms Commit The Commit of HBP Vol.||tee Decision: tee considered the case as per agenda and it was decided I as per details given below or as applied by the firm, whi|||||to fix ad-hoc norms under Pa chever is less:-||ra 4.07| |||||||||||| |||Expo|rt Product||Qty.|Sl. No.|Impor|t Items|Qty. all|owed.| |||||||||||| |||Saxaglipt Cyano-2-|in intermediates (N-[2-(3- Azabicyclo [3.1.0] Hexan-2-||1 kg.|1|(2S)-2 adama|-(3-hydroxy-1- ntyl)-2-[(2-|0.98|| ||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

methylpropan-2-yl)<br>oxycarbonylamino] acetic<br>acid<br>YL)-1-(3-<br>Hydroxy-1-Adamantyl)-2-Oxoethyl]<br>Carbamate (GL-III)))<br>2<br>(1S,3S,5S)-2-azabicyclo<br>[3.1.0] hexane-3-<br>carboxamide;<br>methanesulfonic acid<br>0.70 kg.<br>RA concerned may take further necessary action as per above decision of NC.	YL)-1-(3-<br>Hydroxy-1-Adamantyl)-2-Oxoethyl]<br>Carbamate (GL-III)))			methylpropan-2-yl)<br>oxycarbonylamino] acetic<br>acid
			2	(1S,3S,5S)-2-azabicyclo<br>[3.1.0] hexane-3-<br>carboxamide;<br>methanesulfonic acid	0.70 kg.

GL-III)))|||methylpropan-2-yl) oxycarbonylamino] acetic acid|| |---|---|---|---|---|---| ||||2|(1S,3S,5S)-2-azabicyclo [3.1.0] hexane-3- carboxamide; methanesulfonic acid|0.70 kg.|

Case No.	19 / NC/3/MEET/Oct/202526/9
Case Status	Case Deferred
Party Name	METROCHEM API PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006306AM25
RA File Number	26AX04000061 AM25
Licence No and<br>Date	2611001813/19/02/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Hearing<br> before Norms Committee to explain its case along with relevant information / documents<br>firm.<br>Complete chemistry not given.<br>1.<br>Moler yields not given.<br>2.<br>Solvent recovery not given.<br>3.<br>Norms applied are not proportional to their molecular weight.<br>4.		Personal<br>from the

Case No.	20 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	VISWAAT CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

e|NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

HQ File Number	HQRNORM APPLY 00006327AM25
RA File Number	03AX04005955 AM25
Licence No and<br>Date	0311041523/20/02/2025
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in the meeting No. NC/3/MEET/Feb/202425/17 dated 25/02/2025 against<br>Advance Authorisation No. 0311025198 dt. 06/07/2023, 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>Ammonia Gas<br>15.3 MT<br>Vicasol MV 06<br>[Poly-Isopropanol Amines]<br>750 MT<br>2<br>Propylene Oxide<br>749.7 MT<br>RA concerned may take further necessary action as per above decision of NC.

Ammonia Gas 15.3 MT Vicasol MV 06 [Poly-Isopropanol Amines] 750 MT 2 Propylene Oxide 749.7 MT RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	21 / NC/3/MEET/Oct/202526/9	21 / NC/3/MEET/Oct/202526/9	21 / NC/3/MEET/Oct/202526/9	21 / NC/3/MEET/Oct/202526/9	21 / NC/3/MEET/Oct/202526/9
Case Status		Case Approved
Party Name		AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number		HQRNORM APPLY 00006340AM25
RA File Number		08AX04002003 AM25
Licence No and<br>Date		0811014208/21/02/2025
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in the meeting No. NC/3/MEET/Sep/202526/08 dated 17.09.2025 against<br>Advance Authorisation No. 0711013550 dt. 04/02/2025, 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.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

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

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Tranexamic<br>Acid<br>Injection<br>100 mg / mL (10 ml.)<br>21739 Vials<br>1<br>Tranexamic acid<br>(Injectable grade, US FDA<br>approved)<br>22.826 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Tranexamic<br>Acid<br>Injection<br>100 mg / mL (10 ml.)	<br>21739 Vials	1	Tranexamic acid<br>(Injectable grade, US FDA<br>approved)	22.826 kg.

Case No.	Case No.	Case No.	22 / NC/3/MEET/Oct/202526/9	22 / NC/3/MEET/Oct/202526/9	22 / NC/3/MEET/Oct/202526/9
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number			HQRNORM APPLY 00006342AM25
RA File Number			03AX04005961 AM25
Licence No and<br>Date			0311041536/21/02/2025
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. Export Product<br>Quantity<br>1<br>Medical Cream & Onitment(Mesalamine Rectal Suspension, USP Enema 4.0 g /<br>60 ml (Tot Wt: 73944 Kgs (Net Cont: Mesalamine 5028.19 Kgs, POTASSIUM<br>METABISULFITE NF 347.17, POTASSIUM ACETATE 303.17 kgs LDPE<br>Bottle 1200000 Nos, Enema Applictor 1200000 Nos.))<br>1 Number<br>Sl. No.

t Wt: 73944 Kgs (Net Cont: Mesalamine 5028.19 Kgs, POTASSIUM METABISULFITE NF 347.17, POTASSIUM ACETATE 303.17 kgs LDPE Bottle 1200000 Nos, Enema Applictor 1200000 Nos.)) 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 Cream & Onitment(Mesalamine Rectal Suspension, USP Enema 4.0 g / 60 ml (Tot Wt: 73944 Kgs (Net Cont: Mesalamine 5028.19 Kgs, POTASSIUM METABISULFITE NF 347.17, POTASSIUM ACETATE 303.17 kgs LDPE Bottle 1200000 Nos, Enema Applictor 1200000 Nos.)) |||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: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

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.	23 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006377AM25
RA File Number	07AX04001967 AM25
Licence No and<br>Date	0711013735/24/02/2025
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in the meeting No. NC/3/MEET/Jul/202526/6 dated 31.07.2025 against<br>Advance Authorisation No. 0711013122 dt. 23/12/2024, 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>Direct Compression Granules of<br>Phloroglucinol 160 mg. ODT Premix<br>(Each 450 mg Premix Contains 160<br>mg Phloroglucinol) Contents 384 kg.<br>of Phloroglucinol)<br>1 Kg.<br>1<br>Phloroglucinol Dihydrate<br>BP/EP/IP/USP)<br>0.359 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	24 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025

Case No.	24 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

HQ File Number	HQRNORM APPLY 00006382AM25
RA File Number	03AX04005991 AM25
Licence No and<br>Date	0311041604/24/02/2025
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. Export Product<br>Quantity<br>1<br>Medical Cream and Onitment (Glycerine Vaseline and Paraffin Cream 250 gm<br>[Total Wt. 750000 Kgs (Net Cont: Gly112500 Kgs,Vase 60000 Kgs, Para Liq<br>15000 Kgs, Ste 50% 15750 Kgs, Ste 95% 6750 Kgs, Cyclo18750 Kgs, Sili 3750<br>Kgs, Mac 37500 Kgs, Trie 3750 Kgs)])<br>1 Number<br>Sl. No. Import Product<br>Quantity allowed.<br>1<br>Relevant Bulk Drugs<br>Net content in the export product plus 2% wastage.<br>2<br>Relevant Excipients<br>Net content in the export product plus 2% wastage.<br>3<br>Relevant Packaging Material<br>Relevant as per Packing Policy & General Notes.<br>Note:<br>The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA<br>concerned for redemption.<br>i.<br>RA concerned may take further necessary action as per above decision of NC.

weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption. i. RA concerned may take further necessary action as per above decision of NC.||

Case No.	25 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	GALAXY SURFACTANTS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006383AM25

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

RA File Number	03AX04005975 AM25
Licence No and<br>Date	0311041607/24/02/2025
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in the meeting No. NC/3/MEET/May/202526/3 dated 04/06/2025 against<br>Advance Authorisation No. 0311032511 dt. 26/03/2024, 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>Phenol<br>0.690 kg.<br>Phenoxyethanol<br>1 kg.<br>2<br>Ethylene Oxide<br>0.325 kg.<br>RA concerned may take further necessary action as per above decision of NC.<br>Note:The committee also decided to review SION A-2005.

RA File Number

03AX04005975 AM25

Licence No and Date

0311041607/24/02/2025

Norms Committee Decision: The Committee considered the case as per the agenda and taking cue from the earlier decision for the same export product/import item in the meeting No. NC/3/MEET/May/202526/3 dated 04/06/2025 against Advance Authorisation No. 0311032511 dt. 26/03/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Phenol 0.690 kg. Phenoxyethanol 1 kg. 2 Ethylene Oxide 0.325 kg. RA concerned may take further necessary action as per above decision of NC. **Note:**The committee also decided to review SION A-2005.

yethanol 1 kg. 2 Ethylene Oxide 0.325 kg. RA concerned may take further necessary action as per above decision of NC. **Note:**The committee also decided to review SION A-2005.||

Case No.	26 / NC/3/MEET/Oct/202526/9
Case Status	Case Deferred
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006409AM25
RA File Number	07AX04001966 AM25
Licence No and<br>Date	0711013758/25/02/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>Import quantity is not matching with export. Complete calculation sheet in support of import quantity may<br>be furnished.

Case No.	27 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

2526/9| |---|---| |Case Status|Case Approved|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Party Name	GALAXY SURFACTANTS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006393AM25
RA File Number	03AX04005983 AM25
Licence No and<br>Date	0311041620/25/02/2025
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in the meeting No. NC/3/MEET/May/202526/3 dated 04/06/2025 against<br>Advance Authorisation No. 0311032511 dt. 26/03/20204, 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>Phenol<br>0.690 kg.<br>Phenoxyethanol<br>1 kg.<br>2<br>Ethylene Oxide<br>0.325 kg.<br>RA concerned may take further necessary action as per above decision of NC.

t Items Qty. allowed. 1 Phenol 0.690 kg. Phenoxyethanol 1 kg. 2 Ethylene Oxide 0.325 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	28 / NC/3/MEET/Oct/202526/9	28 / NC/3/MEET/Oct/202526/9	28 / NC/3/MEET/Oct/202526/9	28 / NC/3/MEET/Oct/202526/9	28 / NC/3/MEET/Oct/202526/9
Case Status		Case Approved
Party Name		GALAXY SURFACTANTS LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number		HQRNORM APPLY 00006394AM25
RA File Number		03AX04005981 AM25
Licence No and<br>Date		0311041621/25/02/2025
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in the meeting No. NC/3/MEET/May/202526/3 dated 04/06/2025 against<br>Advance Authorisation No. 0311032511 dt. 26/03/20204, 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.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

s given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

Case No.	Case No.	28 / NC/3/MEET/Oct/202526/9	28 / NC/3/MEET/Oct/202526/9	28 / NC/3/MEET/Oct/202526/9	28 / NC/3/MEET/Oct/202526/9	28 / NC/3/MEET/Oct/202526/9
Case Status		Case Approved
Party Name		GALAXY SURFACTANTS LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number		HQRNORM APPLY 00006394AM25
RA File Number		03AX04005981 AM25
Licence No and<br>Date		0311041621/25/02/2025
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in the meeting No. NC/3/MEET/May/202526/3 dated 04/06/2025 against<br>Advance Authorisation No. 0311032511 dt. 26/03/20204, 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.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

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

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

1<br>Phenol<br>0.690 kg.<br>Phenoxyethanol<br>1 kg.<br>2<br>Ethylene Oxide<br>0.325 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Phenoxyethanol	1 kg.	1	Phenol	0.690 kg.
			2	Ethylene Oxide	0.325 kg.

Case No.	Case No.	Case No.	29 / NC/3/MEET/Oct/202526/9	29 / NC/3/MEET/Oct/202526/9	29 / NC/3/MEET/Oct/202526/9
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number			HQRNORM APPLY 00006416AM25
RA File Number			03AX04006015 AM25
Licence No and<br>Date			0311041641/25/02/2025
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.

ision: The Committee considered the request of firm for fixation of ad-hoc norms and on the basis of information provided by the firm, it was decided to fix ad-hoc norms as under:- Sl. No. Export Product Quantity 1 Medical Cream & Ointment (TRETINOIN MICROSPHERE TOPICAL GEL 0.08% 50 Gm (Net Wt 2500 Kgs, Net cont: Tretinoin USP 2.20 Kgs, PPG-20 Methyl Glucose 118.75 Kgs, Empty Bottle 50000 Nos, Pump Over cap 50000)) 1 Number 2 Medical Cream & Ointment (TRETINOIN MICROSPHERE TOPICAL GEL 0.06% 50 Gm (Net Wt 3000 Kgs, Net cont: Tretinoin USP 1.980 Kgs, PPG-20 Methyl Glucose 142.5 Kgs, Empty Bottle 60000 Nos, Pump Over cap 60000)) 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.|||||| ||Sl. No.|Export Product |||Quantity| ||1|Medical Cream & Ointment (TRETINOIN MICROSPHERE TOPICAL GEL 0.08% 50 Gm (Net Wt 2500 Kgs, Net cont: Tretinoin USP 2.20 Kgs, PPG-20 Methyl Glucose 118.75 Kgs, Empty Bottle 50000 Nos, Pump Over cap 50000)) |||1 Number| ||2|Medical Cream & Ointment (TRETINOIN MICROSPHERE TOPICAL GEL 0.06% 50 Gm (Net Wt 3000 Kgs, Net cont: Tretinoin USP 1.980 Kgs, PPG-20 Methyl Glucose 142.5 Kgs, Empty Bottle 60000 Nos, Pump Over cap 60000)) |||1 Number| ||||||| ||Sl.

OSPHERE TOPICAL GEL 0.06% 50 Gm (Net Wt 3000 Kgs, Net cont: Tretinoin USP 1.980 Kgs, PPG-20 Methyl Glucose 142.5 Kgs, Empty Bottle 60000 Nos, Pump Over cap 60000)) |||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.||

Case No.	Case No.	Case No.	29 / NC/3/MEET/Oct/202526/9	29 / NC/3/MEET/Oct/202526/9	29 / NC/3/MEET/Oct/202526/9
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number			HQRNORM APPLY 00006416AM25
RA File Number			03AX04006015 AM25
Licence No and<br>Date			0311041641/25/02/2025
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. Export Product<br>Quantity<br>1<br>Medical Cream & Ointment (TRETINOIN MICROSPHERE TOPICAL GEL<br>0.08% 50 Gm (Net Wt 2500 Kgs, Net cont: Tretinoin USP 2.20 Kgs, PPG-20<br>Methyl Glucose 118.75 Kgs, Empty Bottle 50000 Nos, Pump Over cap 50000))<br>1 Number<br>2<br>Medical Cream & Ointment (TRETINOIN MICROSPHERE TOPICAL GEL<br>0.06% 50 Gm (Net Wt 3000 Kgs, Net cont: Tretinoin USP 1.980 Kgs, PPG-20<br>Methyl Glucose 142.5 Kgs, Empty Bottle 60000 Nos, Pump Over cap 60000))<br>1 Number<br>Sl. No.

IN MICROSPHERE TOPICAL GEL 0.06% 50 Gm (Net Wt 3000 Kgs, Net cont: Tretinoin USP 1.980 Kgs, PPG-20 Methyl Glucose 142.5 Kgs, Empty Bottle 60000 Nos, Pump Over cap 60000)) 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.|||||| ||Sl. No.|Export Product |||Quantity| ||1|Medical Cream & Ointment (TRETINOIN MICROSPHERE TOPICAL GEL 0.08% 50 Gm (Net Wt 2500 Kgs, Net cont: Tretinoin USP 2.20 Kgs, PPG-20 Methyl Glucose 118.75 Kgs, Empty Bottle 50000 Nos, Pump Over cap 50000)) |||1 Number| ||2|Medical Cream & Ointment (TRETINOIN MICROSPHERE TOPICAL GEL 0.06% 50 Gm (Net Wt 3000 Kgs, Net cont: Tretinoin USP 1.980 Kgs, PPG-20 Methyl Glucose 142.5 Kgs, Empty Bottle 60000 Nos, Pump Over cap 60000)) |||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.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

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.

Note: The committee also decided to review SION A-1931.

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

Note: The committee also decided to review SION A-1931.

Case No.	30 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	DASAMI LAB PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006398AM25
RA File Number	09AX04001040 AM25
Licence No and<br>Date	0911009094/25/02/2025
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.<br>allowed.<br>Oxcarbazepine (Heterocyclic<br>compounds with nitrogen Hetero-<br>atom (s) Only - Compounds<br>Containing)<br>1 kg.<br>1<br>10-Methoxy-5h-Dibenzo [B.F]<br>Azepine (Diloxanidefuroate,<br>Cimetidine , Oxyclozanide,<br>Famotidine: Other)<br>1.10 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

cessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Case No.	31 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006440AM25
RA File Number	08AX04002018 AM25
Licence No and<br>Date	0811014244/26/02/2025
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>Nicardipine Hydrochloride Injection<br>USP, 2.5 mg. / ml. (10 ml.)<br>1 Number Vial<br>1<br>Nicardipine<br>27.5 mg/Vial<br>Nicardipine Hydrochloride in 0.9%<br>Sodium Chloride Injection, 0.2 mg. / ml.<br>(40 mg / 200 ml.)<br>1 Number Vial<br>2<br>Nicardipine<br>42 mg/Vial<br>Nicardipine Hydrochloride in 0.9%<br>Sodium Chloride Injection, 0.1 mg. / ml.<br>(20 mg / 200 ml.)<br>1 Number Vial<br>3<br>Nicardipine<br>21 mg/Vial<br>RA concerned may take further necessary action as per above decision of NC.

br>Sodium Chloride Injection, 0.1 mg. / ml. (20 mg / 200 ml.) 1 Number Vial 3 Nicardipine 21 mg/Vial RA concerned may take further necessary action as per above decision of NC.||

Case No.<br>	32 / NC/3/MEET/Oct/202526/9
Case Status<br>	Case Deferred
Party Name<br>	RUBICON RESEARCH LIMITED
Meeting Number<br>and Date<br>	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number<br>	HQRNORM APPLY 00006451AM25
RA File Number<br>	03AX04006037 AM25
Licence No and<br>Date<br>	0311041670/27/02/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Norms Committee Decision:

The case is under consideration and TE was requested to expedite his comments.

Case No.	33 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	VENUS REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006453AM25
RA File Number	30AX04000683 AM25
Licence No and<br>Date	3011006585/27/02/2025
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>Ceftriaxone powder for solution for<br>injection 500 mg (Each vial contains:<br>Ceftriaxone Sodium equivalent to<br>ceftriaxone...500mg)<br>1 Number<br>1<br>Ceftriaxone Sodium<br>Sterile<br>580 mg.<br>Ceftriaxone powder for solution for<br>injection1000 mg (Each vial contains:<br>Ceftriaxone sodium Equivalent to<br>ceftriaxone..1000 mg)<br>1 Number<br>2<br>Ceftriaxone Sodium<br>Sterile<br>1.16 gm.<br>Ceftriaxone powder for solution for<br>injection 2000 mg (Each vial contains:<br>Ceftriaxone sodium equivalent to<br>ceftriaxone..2000mg)<br>1 Number<br>3<br>Ceftriaxone Sodium<br>Sterile<br>2.32 gm.<br>RA concerned may take further necessary action as per above decision of NC.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

cessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Case No.	34 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	JUBILANT GENERICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006460AM25
RA File Number	05AX04003972 AM25
Licence No and<br>Date	0511031096/27/02/2025
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>Azithromycin Tablets 250 mg<br>1 Number<br>1<br>Azithromycine PH.EUR<br>(Azithromycin Dihydrate)<br>267.26 mg.<br>Azithromycin Tablets 500 mg<br>1 Number<br>2<br>Azithromycine PH.EUR<br>(Azithromycin Dihydrate)<br>534.52 mg.<br>RA concerned may take further necessary action as per above decision of NC.

. Azithromycin Tablets 500 mg 1 Number 2 Azithromycine PH.EUR (Azithromycin Dihydrate) 534.52 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.<br>	35 / NC/3/MEET/Oct/202526/9
Case Status<br>	Case Approved
Party Name<br>	JUBILANT GENERICS LIMITED
Meeting Number<br>and Date<br>	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number<br>	HQRNORM APPLY 00006461AM25
RA File Number<br>	05AX04004086 AM25
Licence No and<br>Date<br>	0511031098/27/02/2025
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in the meeting No. NC/3/MEET/Apr/202526/1 dated 25/04/2025 against<br>Advance Authorisation No. 0511027868 dt. 20/09/2024, 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: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

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

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Losartan Potassium 25 mg	1 Number	1	Losartan Potassium Ph.Eur<br>(UK)	25.50 mg.
Losartan Potassium 50 mg	1 Number	2	Losartan Potassium Ph.Eur<br>(UK)	51.00 mg.
Losartan Potassium 100 mg	1 Number	3	Losartan Potassium Ph.Eur<br>(UK)	102.00 mg.

m Ph.Eur (UK)|25.50 mg.| ||Losartan Potassium 50 mg|1 Number|2|Losartan Potassium Ph.Eur (UK)|51.00 mg.| ||Losartan Potassium 100 mg|1 Number|3|Losartan Potassium Ph.Eur (UK)|102.00 mg.|

Case No.	36 / NC/3/MEET/Oct/202526/9
Case Status	Case Deferred
Party Name	ALKYL AMINES CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006484AM25
RA File Number	03AX04005963 AM25
Licence No and<br>Date	0311041736/28/02/2025
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>A balanced chemical reaction indicating molecular weight of reactants and products with yield and<br>justification.<br>I.<br>Calculation of the requirement of raw materials based on yield of the reaction.<br>II.<br>A stoichiometric material balance on molar basis.<br>III.<br>The commercial value of the by-product/s, if any, obtained during the process.<br>IV.

Case No.	37 / NC/3/MEET/Oct/202526/9
Case Status	Case Deferred
Party Name	ATUL LIMITED
Meeting Number	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

r|NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

and Date
HQ File Number	HQRNORM APPLY 00006517AM25
RA File Number	08AX04002033 AM25
Licence No and<br>Date	0811014276/03/03/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>A balanced chemical reaction indicating molecular weight of reactants and products with yield and<br>justification.<br>1.<br>Calculation of the requirement of raw materials based on yield of the reaction.<br>2.<br>A stoichiometric material balance on molar basis.<br>3.

Case No.	38 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	SANOFI INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006501AM25
RA File Number	03AX04006096 AM25
Licence No and<br>Date	0311041778/03/03/2025
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in the meeting No. NC/3/MEET/Dec/202425/12 dated 10/12/2024 against<br>Advance Authoristion No. 0311034648 dt. 14/06/2024, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol.

mport item in the meeting No. NC/3/MEET/Dec/202425/12 dated 10/12/2024 against Advance Authoristion No. 0311034648 dt. 14/06/2024, 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. Ramipril PC Granules ((Net content: each 1 gm of Ramipril 850 mg, Total net content Ramipril 5950 kg)) 7000 kg. 1 Ramipril 6009.50 kg. RA concerned may take further necessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Case No.	39 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006498AM25
RA File Number	09AX04000930 AM25
Licence No and Date	0911009126/03/03/2025
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.<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. Dipyridamole modified release and Acetyl Salicyclic Acid Capsules 200 mg + 25 mg - Brand Name : (Orisantin 200 mg / 25 mg depotkapseli, kova/kapsel med modifierad frisattning, hard) Pack Size : 100s (Consist of 1600.00 Kgs of Dipyridamole - Ph Eur ) 1 Number 1 Dipyridamole - PH Eur 204.0 mg./Capsule Dipyridamole modified release and Acetyl Salicyclic Acid Capsules 200 mg + 25 mg - Brand Name : (Diprasorin 200 mg / 25 mg hardkapsel med modifieradfrisattning/ hardkapsel med modifisertfr) Pack Size : 100s (Consist of 1600.00 Kgs of Dipyridamole - Ph Eur ) 1 Number 2 Dipyridamole - PH Eur 204.0 mg./Capsule Dipyridamole Modified Release capsules 200 mg Pack Size : 60s (Consist of 420 Kgs of Dipyridamole - Ph Eur ) 1 Number 3 Dipyridamole - PH Eur 204.0 mg./Capsule RA concerned may take further necessary action as per above decision of NC.||

Case No.	40 / NC/3/MEET/Oct/202526/9
Case Status	Case Deferred
Party Name	ENALTEC LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

e|NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

HQ File Number	HQRNORM APPLY 00006530AM25
RA File Number	03AX04006114 AM25
Licence No and<br>Date	0311041804/04/03/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>Complete technical details as per Annexure to Appendix 4E.

Case No.	41 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006540AM25
RA File Number	05AX04003991 AM25
Licence No and<br>Date	0511031191/04/03/2025
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in the meeting No. NC/3/MEET/May/202526/3 dated 04/06/2025 against<br>Advance Authorisation No, 0311037863 dt. 11/10/2024, 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.

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. Meropenem Sodium Sterile (Meropenem for injection) (Containing NLT 84% Sterile Meropenem) 1 kg. 1 Meropenem Trihydrate (Non Sterile) 0.8968 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	42 / NC/3/MEET/Oct/202526/9
Case Status	Case Deferred

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Party Name	LECIPURE BIOTECH LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006544AM25
RA File Number	08AX04002069 AM25
Licence No and<br>Date	0811014307/04/03/2025
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>1. Complete Certificate of Analysis (CoA) of import and export.<br>2. Technical difference between imort and export.<br>3. Sample of copy of actual shipping bill and bill of entry.

firm:- 1. Complete Certificate of Analysis (CoA) of import and export. 2. Technical difference between imort and export. 3. Sample of copy of actual shipping bill and bill of entry.||

Case No.	Case No.	43 / NC/3/MEET/Oct/202526/9	43 / NC/3/MEET/Oct/202526/9	43 / NC/3/MEET/Oct/202526/9	43 / NC/3/MEET/Oct/202526/9	43 / NC/3/MEET/Oct/202526/9
Case Status		Case Approved
Party Name		ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number		HQRNORM APPLY 00006549AM25
RA File Number		08AX04002006 AM25
Licence No and<br>Date		0811014312/04/03/2025
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in the meeting No. NC/3/MEET/Mar/202425/18 dated 17/03/2025 against<br>Advance Authoristion No. 0811008323 dt. 06/06/2023, 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>Norelgestromin USP<br>5.8475 mg/Patch<br>Norelgestromin and Ethinyl<br>Estradiol Transdermal System<br>150/35 mcg. per day ((Each<br>15.75 CM2 Patch Contains:<br>Norelgestromin USP 4.678 mg.<br>to provide Norelgestromin 150<br>mcg./ day & Ethinyl Estradiol<br>1 Patch<br>2<br>Ethinyl Estradiol USP<br>0.6625 mg/Patch
	Export Product		Qty.	Sl. No.	Import Items	Qty.

min USP 4.678 mg. to provide Norelgestromin 150 mcg./ day & Ethinyl Estradiol 1 Patch 2 Ethinyl Estradiol USP 0.6625 mg/Patch||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Norelgestromin and Ethinyl Estradiol Transdermal System 150/35 mcg. per day ((Each 15.75 CM2 Patch Contains: Norelgestromin USP 4.678 mg. to provide Norelgestromin 150 mcg./ day & Ethinyl Estradiol||1 Patch|1|Norelgestromin USP|5.8475 mg/Patch| |||||2|Ethinyl Estradiol USP|0.6625 mg/Patch|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

USP 0.53 mg. to provide Ethinyl Estradiol 35 mcg./day) (Net Wt. Norelgestromin USP - 57.545 kgs & Ethinyl Estradiol USP - 6.520 kgs))

Case No.	44 / NC/3/MEET/Oct/202526/9
Case Status	Case Rejected
Party Name	ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006529AM25
RA File Number	03AX04006135 AM25
Licence No and<br>Date	0311041803/04/03/2025
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).

nd Date|0311041803/04/03/2025| |Norms Committee Decision: The firm was granted an Advance Authorisation for the export product_“COUMARIN”_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 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: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

ith the above decision of the Committee.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Case No.	45 / NC/3/MEET/Oct/202526/9
Case Status	Case Deferred
Party Name	SV PLASTOCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006571AM25
RA File Number	31AX04000435 AM25
Licence No and<br>Date	3111004491/05/03/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>Complete chemical name of export product along copy of shipping bill percentage yield of reaction<br>at every stage of reaction and over all yield in the process.<br>1.

Case No.<br>	46 / NC/3/MEET/Oct/202526/9
Case Status<br>	Case Approved
Party Name<br>	VENUS REMEDIES LIMITED
Meeting Number<br>and Date<br>	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number<br>	HQRNORM APPLY 00006564AM25
RA File Number<br>	30AX04000702 AM25
Licence No and<br>Date<br>	3011006632/05/03/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 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>Topotecan Hydrochloride for Injection<br>4.0 mg.

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. Topotecan Hydrochloride for Injection 4.0 mg. (Each vial contains: Topotecan Hydrochloride Equivalent to Topoteca 4 mg.) 1 Number 1 Topotecan Hydrochloride 4.78 mg. RA concerned may take further necessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Case No.	47 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	JUBILANT GENERICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006558AM25
RA File Number	05AX04004087 AM25
Licence No and<br>Date	0511031203/05/03/2025
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in the meeting No. NC/3/MEET/May/202526/3 dated 04/06/2025 against<br>Advance Authorisation No.0511028382 dated 18/11/2024; 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.

028382 dated 18/11/2024; 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. Cyclobenzaprine Hydrochloride Tablets USP 5 mg. 1 Number 1 Cyclobenzaprine Hydrochloride 5.10 mg Cyclobenzaprine Hydrochloride Tablets USP 7.5 mg. 1 Number 2 Cyclobenzaprine Hydrochloride 7.65 mg Cyclobenzaprine Hydrochloride Tablets USP 10 mg. 1 Number 3 Cyclobenzaprine Hydrochloride 10.20 mg RA concerned may take further necessary action as per above decision of NC.||

Case No.	48 / NC/3/MEET/Oct/202526/9
Case Status	Case Deferred
Party Name	JALAQUA INTERNATIONAL LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006572AM25
RA File Number	52AX04000393 AM25

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Licence No and 5211012300/05/03/2025 Date 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:-

Full chemical name of export item and to give a balanced chemical reaction indicating molecular weight of reactants and products with yield and justification.

rmation/documents from the firm:-

Full chemical name of export item and to give a balanced chemical reaction indicating molecular weight of reactants and products with yield and justification.
Calculation of the requirement of raw materials based on yield of the reaction.
A stoichiometric material balance on molar basis.

Case No.	Case No.	49 / NC/3/MEET/Oct/202526/9	49 / NC/3/MEET/Oct/202526/9	49 / NC/3/MEET/Oct/202526/9	49 / NC/3/MEET/Oct/202526/9	49 / NC/3/MEET/Oct/202526/9
Case Status		Case Approved
Party Name		SPAR PHARMA LLP
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number		HQRNORM APPLY 00006593AM25
RA File Number		09AX04001124 AM25
Licence No and<br>Date		0911009149/06/03/2025
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in the meeting No. NC/3/MEET/Jun/202526/5 dated 30/06/2025 against<br>Advance Authorisation No. 0911008449 dated 22/11/2024, 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.

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 Aniline Oil (Liquid) 0.47 kg. 2 Fluorobenzene (Liquid) 0.52 kg. 3 Acetone (Liquid) 0.50 kg. 4 Methyl Aceto Acetate (Liquid) 1.06 kg. 4-FLUORO-a-2-METHYL-1- OXOPROPYL)-g-OXO-N-B- DIPHENYL BENZENE BUTANEAMIDE (DIKETONE, INTERMEDIATE FOR ATORVASTATIN /DKT-3(SOLID) 1 kg. 5 Iso Butyryl Chloride (Liquid) 0.97 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||4-FLUORO-a-2-METHYL-1- OXOPROPYL)-g-OXO-N-B- DIPHENYL BENZENE BUTANEAMIDE (DIKETONE, INTERMEDIATE FOR ATORVASTATIN /DKT-3(SOLID)|| 1 kg.|1|Aniline Oil (Liquid)|0.47 kg.| |||||2|Fluorobenzene (Liquid)|0.52 kg.| |||||3|Acetone (Liquid)|0.50 kg.| |||||4|Methyl Aceto Acetate (Liquid)|1.06 kg.| |||||5|Iso Butyryl Chloride (Liquid)|0.97 kg.| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Butyryl Chloride (Liquid)|0.97 kg.| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Case No.	Case No.	50 / NC/3/MEET/Oct/202526/9	50 / NC/3/MEET/Oct/202526/9	50 / NC/3/MEET/Oct/202526/9	50 / NC/3/MEET/Oct/202526/9	50 / NC/3/MEET/Oct/202526/9
Case Status		Case Approved
Party Name		SPAR PHARMA LLP
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number		HQRNORM APPLY 00006592AM25
RA File Number		09AX04001125 AM25
Licence No and<br>Date		0911009148/06/03/2025
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in the meeting No. NC/3/MEET/Jun/202526/5 dated 30/06/2025 against<br>Advance Authorisation No. 0911008449 dated 22/11/2024, 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.

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 Aniline Oil (Liquid) 0.47 kg. 2 Fluorobenzene (Liquid) 0.52 kg. 3 Acetone (Liquid) 0.50 kg. 4 Methyl Aceto Acetate (Liquid) 1.06 kg. 4-FLUORO-a-2-METHYL-1- OXOPROPYL)-g-OXO-N-B- DIPHENYL BENZENE BUTANEAMIDE (DIKETONE, INTERMEDIATE FOR ATORVASTATIN /DKT-3(SOLID) 1 kg. 5 Iso Butyryl Chloride (Liquid) 0.97 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||4-FLUORO-a-2-METHYL-1- OXOPROPYL)-g-OXO-N-B- DIPHENYL BENZENE BUTANEAMIDE (DIKETONE, INTERMEDIATE FOR ATORVASTATIN /DKT-3(SOLID)|| 1 kg.|1|Aniline Oil (Liquid)|0.47 kg.| |||||2|Fluorobenzene (Liquid)|0.52 kg.| |||||3|Acetone (Liquid)|0.50 kg.| |||||4|Methyl Aceto Acetate (Liquid)|1.06 kg.| |||||5|Iso Butyryl Chloride (Liquid)|0.97 kg.| |||||per above decision of NC.|||

Case No.	51 / NC/3/MEET/Oct/202526/9
Case Status	Case Deferred
Party Name	MISTAIR HEALTH AND HYGIENE PRIVATE LIMITED

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

e|MISTAIR HEALTH AND HYGIENE PRIVATE LIMITED|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006607AM25
RA File Number	03AX04006115 AM25
Licence No and<br>Date	0311041942/07/03/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that<br>with export quantity, therefore; it was decided to call the firm for attending <br>Committee to explain its case with complete working/justification.		import quantity has no match<br>Personal Hearing<br> before Norms

Case No.	52 / NC/3/MEET/Oct/202526/9
Case Status	Case Deferred
Party Name	APITORIA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006613AM25
RA File Number	09AX04001129 AM25
Licence No and<br>Date	0911009156/07/03/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>Molecular weight of export product.<br>1.<br>Composition of export item as usedin export.<br>2.<br>Certificate of Analysis (CoA) of export item to show copovidone content.<br>3.<br>Recovery of solvent.<br>4.

ght of export product. 1. Composition of export item as usedin export. 2. Certificate of Analysis (CoA) of export item to show copovidone content. 3. Recovery of solvent. 4.||

Case No.	53 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	KLJ PETROPLAST LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006598AM25
RA File Number	05AX04004170 AM25
Licence No and<br>Date	0511031246/07/03/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

|Nor Th ex A 4. RA|ms Committee Decision: e Committee considered the case as per the agenda and taking cue from the earlier decision for the same port product/import item in the meeting No. NC/3/MEET/Jun/202526/5 dated 30/06/2025 against dvance Authorisation No. 0511028685 dt. 01/11/2024, it was decided to fix ad-hoc norms under Para 07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-|ms Committee Decision: e Committee considered the case as per the agenda and taking cue from the earlier decision for the same port product/import item in the meeting No. NC/3/MEET/Jun/202526/5 dated 30/06/2025 against dvance Authorisation No. 0511028685 dt. 01/11/2024, it was decided to fix ad-hoc norms under Para 07 of HBP Vol.

t/import item in the meeting No. NC/3/MEET/Jun/202526/5 dated 30/06/2025 against dvance Authorisation No. 0511028685 dt. 01/11/2024, it was decided to fix ad-hoc norms under Para 07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-|ms Committee Decision: e Committee considered the case as per the agenda and taking cue from the earlier decision for the same port product/import item in the meeting No. NC/3/MEET/Jun/202526/5 dated 30/06/2025 against dvance Authorisation No. 0511028685 dt. 01/11/2024, it was decided to fix ad-hoc norms under Para 07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-|ms Committee Decision: e Committee considered the case as per the agenda and taking cue from the earlier decision for the same port product/import item in the meeting No. NC/3/MEET/Jun/202526/5 dated 30/06/2025 against dvance Authorisation No. 0511028685 dt. 01/11/2024, it was decided to fix ad-hoc norms under Para 07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-|ms Committee Decision: e Committee considered the case as per the agenda and taking cue from the earlier decision for the same port product/import item in the meeting No. NC/3/MEET/Jun/202526/5 dated 30/06/2025 against dvance Authorisation No. 0511028685 dt. 01/11/2024, it was decided to fix ad-hoc norms under Para 07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-| |---|---|---|---|---|---| ||Export Product|Qty.|Sl.

/2024, it was decided to fix ad-hoc norms under Para 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.| ||Di-Ethyl Phthalate (DEP) (Packed In 2000 Nos. of HM-HDPE Drums made of HDPE Granules (17,000.000 Kgs. without wastage)) (each Drum shall weight 8.5 Kg and Storage Capacity 250.000 Kgs.))| 1 kg.|1|Phthalic Anhydride|0.700 kg.| ||||2|Denatured Ethyl Alcohol|0.435 kg.| ||||3|HDPE Granules (Total weight =17,850.000 kg.)|As per Packing Policy and Genral Notes.| ||concerned may take further necessary action as per above decision of NC.|||||

Norms Committee Decision:

The Committee considered the case as per the agenda and taking cue from the earlier decision for the same export product/import item in the meeting No. NC/3/MEET/Jun/202526/5 dated 30/06/2025 against Advance Authorisation No. 0511028685 dt. 01/11/2024, 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:-

Case No.	Case No.	54 / NC/3/MEET/Oct/202526/9	54 / NC/3/MEET/Oct/202526/9	54 / NC/3/MEET/Oct/202526/9	54 / NC/3/MEET/Oct/202526/9	54 / NC/3/MEET/Oct/202526/9
Case Status		Case Approved
Party Name		HONOUR LAB LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number		HQRNORM APPLY 00006602AM25
RA File Number		09AX04001103 AM25
Licence No and<br>Date		0911009153/07/03/2025
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>(+/-)-6,6'-Dibromo-1,1'-bi-2-<br>naphthol (Phenols; phenol-alcohols<br>Monophenols)<br>1 kg.<br>1<br>1,1 -Bi-2-Naphthol (Binol)<br>(polyphenols)<br>0.72 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	(+/-)-6,6'-Dibromo-1,1'-bi-2-<br>naphthol (Phenols; phenol-alcohols<br>Monophenols)		1 kg.	1	1,1 -Bi-2-Naphthol (Binol)<br>(polyphenols)	0.72 kg.

.|Sl. No.|Import Items|Qty. allowed.| ||(+/-)-6,6'-Dibromo-1,1'-bi-2- naphthol (Phenols; phenol-alcohols Monophenols)||1 kg.|1|1,1 -Bi-2-Naphthol (Binol) (polyphenols)|0.72 kg.| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26


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



Cas	e No.	55 / NC/3/MEET/Oct/202526/9
Cas	e Status	Case Approved

Par	ty Name	AEGIS LIFESCIENCES PRIVATE		LIMITED
Me<br>and	eting Number	NC/ 3/ MEET/ Oct/ 202526/ 9 and 1		/10/2025
	Date
HQ	File Number	HQRNORM APPLY 00006620AM2		5
RA	File Number	08AX04002020 AM25

Lic<br>Dat	ence No and<br>e	0811014352/10/03/2025
Norms Committee Decision:
The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in the meeting No. NC/3/MEET/Jul/202526/6 dated 31/07/2025 against<br>Advance Authorisation No.0811013741 dated 08/01/2025, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-


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

rms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||||||||||| |||||||||||| |||||||||||| ||Export P|roduct|Qty.||Sl. No.|Import Items|||Qty. allowed.|| |||||||||||| ||SURGI-ORC |ORIGINAL 4X8 | 48000 Pieces||1|Oxidized Cellulose Sheet, |||48000 Pieces|| ||INCH (Oxidi |zed Regenerated||||10.2x20.3 cm||||| ||Cellulose)|||||||||| |||||||||||| ||SURGI-ORC|KNIT 3X4|13800 Pieces||2|Oxidized Cellulose Sheet,|||13800 Pieces|| ||INCH (Oxidized Regenerated Cellulose)||||| 7,6x10,2 cm||||| ||SURGI-ORC KNIT 6X9 INCH (Oxidized Regenerated ||3000 Pieces||3|Oxidized Cellulose Sheet, 15,2x22,9 cm|||3000 Pieces|| ||Cellulose)|||||||||| ||SURGI-ORC FIBRIL 2X4 INCH (Oxidized Regenerated||10800 Pieces||4|Oxidized Cellulose Sheet, 5,1x10,2 cm|||10800 Pieces|| ||Cellulose)|||||||||| |||||||||||| |||||||||||| ||SURGI-ORC|FIBRIL 4X4|6600 Pieces||5|Oxidized Cellulose Sheet|||6600 Pieces|| || INCH (Oxidi Celllose)| zed Regenerated||||, 10,2x10,2 cm||||| ||u||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Oxidized Regenerated	5400 Pieces	6	Oxidized Cellulose Sheet	5400 Pieces
Cellulose (Oxidized			5.1X35.6 cm
Regenerated Cellulose)
SURGI-ORC ORIGINAL 2X3	<br>72000 Pieces	7	Oxidized cellulose sheet,,	72000 Pieces
INCH (Oxidized Regenerated			5,1x7,6 cm
Cellulose)

idized|||5.1X35.6 cm|| |Regenerated Cellulose)||||| |SURGI-ORC ORIGINAL 2X3| 72000 Pieces|7|Oxidized cellulose sheet,,|72000 Pieces| |INCH (Oxidized Regenerated|||5,1x7,6 cm|| |Cellulose)|||||


	Oxidized Reg<br>Cellulose (O	enerated<br>xidized	5400 Pieces			6		Oxidized Cellulose Sheet<br>5.1X35.6 cm	5400 Pieces
RA	Regenerated Cellulose)
	SURGI-ORC ORIGINAL 2X3<br>INCH (Oxidized Regenerated<br>Cellulose)		<br>72000 Pieces			7		Oxidized cellulose sheet,,<br>5,1x7,6 cm	72000 Pieces
	concerned may take further necessary acti				on as per above decision of NC.



Cas	e No.	56 / NC/3/MEET/Oc		t/202526/9
Cas	e Status	Case Approved
Par	ty Name	AMNEAL PHARM		ACEUTICA	LS PRIVA		E LIMITED

Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ Oct/		202526/ 9 a	nd 14/10/20		25
HQ	File Number	HQRNORM APPLY		00006621	AM25
RA	File Number	08AX04002085 AM		25
Lic<br>Dat	nce No and
	<br>e	0811014363/10/03/2025
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same
export product/import item in the meeting No. NC/3/MEET/Apr/202526/2 dated 08/05/2025 against<br>Advance Authorisation No.0811012792 dt. 03/10/2024, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol.

import item in the meeting No. NC/3/MEET/Apr/202526/2 dated 08/05/2025 against Advance Authorisation No.0811012792 dt. 03/10/2024, 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.||| |||||||||||||||||| |||||||||||||||||| ||Propofol Injectable Em |||ulsion, USP 200 |||1 Number||||1||Propofol|210 mg./pack||| ||mg. per 20 ml. (10 mg.|||per ml.)||||||||||||| |||||||||||||||||| |||||||||||||||||| ||Propofol Injectable Em|||ulsion, USP 500|||1 Number||||2||Propofol|525 mg./pack||| ||mg. per 50 ml. (10 mg. per ml.)|||||||||||||||| ||Propofol Injectable Emulsion, USP 1,000 mg. per 100 ml. (10 mg. per ml.)||||||1 Number||||3||Propofol|1050 mg./pack||| |||||||||||||||||| |RA concerned may take further necessary action as per above decision of NC.|||||||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

as per above decision of NC.|||||||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Case No.	57 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	AKIZEN LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006640AM25
RA File Number	03AX04006003 AM25
Licence No and<br>Date	0311042019/11/03/2025
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>1<br>Ethyl Trifluoroacetate<br>0.90 kg.<br>Ethyl 4,4,4-Trifluoroacetoacetate<br>1 kg.<br>2<br>Sodium Ethoxide Powder<br>0.47 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	58 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	OPES HEALTH CARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006652AM25
RA File Number	08AX04002129 AM25
Licence No and<br>Date	0811014389/12/03/2025
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:-

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:-||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Metamizaole Magnesium 300<br>mg and Pargeverine<br>Hydrochloride 6 mg Oral Drop<br>((Considering the loss on drying<br>@14.50%<br>of Bulk drug for 300 mg we<br>need to poor 350.88 mg. So net<br>content of the raw material is :-<br>150000 Bottles * 5 ml * 350.88<br>mg = 263.16 Kgs.)<br>150000<br>Numbers<br>1<br>Metamizole Magnesium<br>239.423 kg.<br>Metamizaole Magnesium 300<br>mg and Pargeverine<br>Hydrochloride 6 mg Oral Drop<br>((Considering the loss on drying<br>@14.50%<br>of Bulk drug for 300 mg we<br>need to poor 350.88 mg. So net<br>content of the raw material is :-<br>1500000 Bottles * 15 ml *<br>350.88 mg = 7894.80 Kgs.)<br>1500000<br>Numbers<br>2<br>Metamizole Magnesium<br>7087.50 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
	Metamizaole Magnesium 300<br>mg and Pargeverine<br>Hydrochloride 6 mg Oral Drop<br>((Considering the loss on drying<br>@14.50%<br>of Bulk drug for 300 mg we<br>need to poor 350.88 mg.

|---|---|---| ||Metamizaole Magnesium 300 mg and Pargeverine Hydrochloride 6 mg Oral Drop ((Considering the loss on drying @14.50% of Bulk drug for 300 mg we need to poor 350.88 mg. So net content of the raw material is :- 150000 Bottles * 5 ml * 350.88 mg = 263.16 Kgs.)| 150000 Numbers|1|Metamizole Magnesium|239.423 kg.| ||Metamizaole Magnesium 300 mg and Pargeverine Hydrochloride 6 mg Oral Drop ((Considering the loss on drying @14.50% of Bulk drug for 300 mg we need to poor 350.88 mg. So net content of the raw material is :- 1500000 Bottles * 15 ml * 350.88 mg = 7894.80 Kgs.)| 1500000 Numbers|2|Metamizole Magnesium|7087.50 kg.|

Case No.	59 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006676AM25
RA File Number	05AX04004149 AM25
Licence No and<br>Date	0511031335/13/03/2025
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in the meeting No. NC/3/MEET/Jun/202526/5 dated 30/06/2025 against

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

/MEET/Jun/202526/5 dated 30/06/2025 against||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Advance Authorisation No.0811009695 dt. 18/10/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Cefuroxime Sodium Sterile	1 Kg.	1	Cefuroxime Acid	1.04 Kg.

Note: NC also decided to make new SION for the above export product.

Case No.	60 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006677AM25
RA File Number	08AX04002124 AM25
Licence No and<br>Date	0811014404/13/03/2025
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in the meeting No. NC/3/MEET/Jul/202526/6 dated 31/07/2025 against<br>Advance Authorisation No.0811013691 dt. 03/01/2025, 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>Tranexamic Acid in 0.7% Sodium Chloride<br>Injection1000 mg per100 ml.

en 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 Injection1000 mg per100 ml. (10 mg/ml.) 1 Number 1 Tranexamic acid (Injectable grade,US FDA approved) 1.05 gm/100 ml Vial RA concerned may take further necessary action as per above decision of NC.||

Case No. 61 / NC/3/MEET/Oct/202526/9

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Case Status	Case Deferred
Party Name	NOVA INTERCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006700AM25
RA File Number	08AX04002133 AM25
Licence No and<br>Date	0811014430/17/03/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>Stoichiometric balance on molar basis<br>1.<br>Percentage yield of reaction<br>2.

nd as per the advice of the TE, it was decided to call for following information/documents from the firm:- Stoichiometric balance on molar basis 1. Percentage yield of reaction 2.||

Case No.	62 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006704AM25
RA File Number	05AX04004167 AM25
Licence No and<br>Date	0511031391/17/03/2025
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in the meeting No. NC/3/MEET/May/202526/3 dated 04/06/2025 against<br>Advance Authorisation No.0511028660 dt. 30/10/2024, 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>Mydrimax Eye Drops 5 ml Vials (Each<br>ml contains Tropicamide 0.8% )<br>1 Number<br>1<br>Tropicamide<br>40.8 mg / 5ml Vial<br>RA concerned may take further necessary action as per above decision of NC.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

cessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Case No.	63 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	AARTI PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006741AM25
RA File Number	03AX04006239 AM25
Licence No and<br>Date	0311042281/19/03/2025
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.<br>Import Items<br>Qty. allowed.<br>Caffeine Anhydrous<br>1 kg.<br>1<br>Cyano Acetic Acid 70%<br>0.674 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Sl. No. Import Items Qty. allowed. Caffeine Anhydrous 1 kg. 1 Cyano Acetic Acid 70% 0.674 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.<br>	Case No.<br>	64 / NC/3/MEET/Oct/202526/9	64 / NC/3/MEET/Oct/202526/9	64 / NC/3/MEET/Oct/202526/9	64 / NC/3/MEET/Oct/202526/9	64 / NC/3/MEET/Oct/202526/9
Case Status<br>		Case Approved
Party Name<br>		JUBILANT GENERICS LIMITED
Meeting Number<br>and Date<br>		NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number<br>		HQRNORM APPLY 00006749AM25
RA File Number<br>		05AX04004276 AM25
Licence No and<br>Date<br>		0511031460/19/03/2025
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>Paroxetine Hydrochloride 10mg Tablets<br>1 Number<br>1<br>Paroxetine<br>Hydrochloride<br>Hemihydrate<br>11.609 mg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Paroxetine Hydrochloride 10mg Tablets		1 Number	1	Paroxetine<br>Hydrochloride<br>Hemihydrate	11.609 mg.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

e Hydrochloride Hemihydrate|11.609 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Paroxetine Hydrochloride 20 mg Tablets<br>1 Number<br>2<br>Paroxetine<br>Hydrochloride<br>Hemihydrate<br>23.218 mg.<br>Paroxetine Hydrochloride 30 mg Tablets<br>1 Number<br>3<br>Paroxetine<br>Hydrochloride<br>Hemihydrate<br>34.827 mg.<br>Paroxetine Hydrochloride 40 mg Tablets<br>1 Number<br>4<br>Paroxetine<br>Hydrochloride<br>Hemihydrate<br>46.436 mg.<br>RA concerned may take further necessary action as per above decision of NC.	Paroxetine Hydrochloride 20 mg Tablets	1 Number	2	Paroxetine<br>Hydrochloride<br>Hemihydrate	23.218 mg.
	Paroxetine Hydrochloride 30 mg Tablets	1 Number	3	Paroxetine<br>Hydrochloride<br>Hemihydrate	34.827 mg.
	Paroxetine Hydrochloride 40 mg Tablets	1 Number	4	Paroxetine<br>Hydrochloride<br>Hemihydrate	46.436 mg.

chloride 30 mg Tablets|1 Number|3|Paroxetine Hydrochloride Hemihydrate|34.827 mg.| ||Paroxetine Hydrochloride 40 mg Tablets|1 Number|4|Paroxetine Hydrochloride Hemihydrate|46.436 mg.|

Case No.	65 / NC/3/MEET/Oct/202526/9
Case Status	Case Deferred
Party Name	CHEMPLAST SANMAR LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006756AM25
RA File Number	04AX04001210 AM25
Licence No and<br>Date	0411009312/19/03/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>A balanced chemical reaction indicating molecular weight of reactants and products, with yield of the<br>reaction and justification.<br>1.<br>In the past for the export of same item, Acetone and Dimethyl Carbonate were not asked for,<br>therefore, to give complete justification for import of these items.<br>2.

Case No.	66 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	VENUS REMEDIES LIMITED
Meeting Number	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

r|NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

and Date
HQ File Number	HQRNORM APPLY 00006740AM25
RA File Number	30AX04000731 AM25
Licence No and<br>Date	3011006688/19/03/2025
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in the meeting No. NC/3/MEET/May/202526/3 dated 04/06/2025 against<br>Advance Authorisation No.3011005003 dt. 02/04/2024, 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>Sugammadex solution for Injection<br>100 mg / ml (200 mg / 2 ml) (Each<br>vial of 2 ml contains: Sugammadex<br>Sodium equivalent to sugammadex<br>....... ..... 200 mg Hydrochloric acid<br>3.7% (to adjust pH) and/or Sodium<br>hydroxide (to adjust pH) Water for<br>Injections ......... q.s)<br>1 Number<br>1<br>Sugammadex Sodium<br>239.326 mg<br>RA concerned may take further necessary action as per above decision of NC.

hydroxide (to adjust pH) Water for Injections ......... q.s) 1 Number 1 Sugammadex Sodium 239.326 mg RA concerned may take further necessary action as per above decision of NC.||

Case No.	67 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	KALPSUTRA CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006784AM25
RA File Number	03AX04006179 AM25
Licence No and<br>Date	0311042336/20/03/2025
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in the meeting No. NC/3/MEET/Jun/202526/5 dated 30/06/2025 against<br>Advance Authorisation No.0311038672 dt. 13/11/2024, 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: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Isobornyl Cyclohexanol<br>1 kg.<br>1<br>Gum Turpentine Oil<br>1.582 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
	Isobornyl Cyclohexanol	1 kg.	1	Gum Turpentine Oil	1.582 kg.

ther necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
	Isobornyl Cyclohexanol	1 kg.	1	Gum Turpentine Oil	1.582 kg.

Case No.	68 / NC/3/MEET/Oct/202526/9
Case Status	Case Deferred
Party Name	NAVIN FLUORINE INTERNATIONAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006777AM25
RA File Number	03AX04006396 AM25
Licence No and<br>Date	0311042326/20/03/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>Stoichiometric balance on molar basis andpercentage yield to arrive at the quantity of import asked.<br>1.

Case No.	Case No.	69 / NC/3/MEET/Oct/202526/9	69 / NC/3/MEET/Oct/202526/9	69 / NC/3/MEET/Oct/202526/9	69 / NC/3/MEET/Oct/202526/9	69 / NC/3/MEET/Oct/202526/9
Case Status		Case Approved
Party Name		JODAS EXPOIM PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number		HQRNORM APPLY 00006787AM25
RA File Number		09AX04001156 AM25
Licence No and Date		0911009253/20/03/2025
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.

e 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.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Colistimethate sodium powder for<br>preparation of solution for<br>inhalation1000000 Units Each vial<br>contains: Colistimetha Sodium<br>1000000 Units.<br>300000<br>Numbers<br>1<br>Colistimethate Sodium<br>23.5475 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Colistimethate sodium powder for<br>preparation of solution for<br>inhalation1000000 Units Each vial<br>contains: Colistimetha Sodium<br>1000000 Units.	300000<br>Numbers	1	Colistimethate Sodium	23.5475 kg.

reparation of solution for inhalation1000000 Units Each vial contains: Colistimetha Sodium 1000000 Units.|300000 Numbers|1|Colistimethate Sodium|23.5475 kg.| |---|---|---|---|---|---|

Case No.	70 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006813AM25
RA File Number	05AX04004369 AM25
Licence No and<br>Date	0511031520/21/03/2025
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in the meeting No. NC/3/MEET/Jun/202526/5 dated 30/06/2025 against<br>Advance Authorisation No.0511027226 dt. 20/08/2024, 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>Cynacobalamin Injection USP, 1000<br>mcg / ml, 1ml<br>2275000<br>Numbers<br>1<br>Cyanocobalamin USP<br>2502.50 gm.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	71 / NC/3/MEET/Oct/202526/9
Case Status	Case Deferred
Party Name	DEEPAK NITRITE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006815AM25

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

| |HQ File Number|HQRNORM APPLY 00006815AM25|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

RA File Number	34AX04001096 AM25
Licence No and<br>Date	3411006231/21/03/2025
Norms Committee Decision:<br>The Committee decided to defer the case for next meeting.

Case No.	72 / NC/3/MEET/Oct/202526/9
Case Status	Case Deferred
Party Name	CONNEX PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006795AM25
RA File Number	26AX04000067 AM25
Licence No and<br>Date	2611001859/21/03/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>A balanced chemical reaction indicating molecular weight of reactants and products with yield and<br>accordingly to give the requirement of raw materials.<br>1.<br>Generally, the direct reaction between Methyl Chloroformate and Isopropyl Alcohol is not the<br>standard industrial synthesis route for manufacture Chloromethyl Isopropyl Carbonate, therefore, to<br>justify the same.<br>2.

A balanced chemical reaction indicating molecular weight of reactants and products with yield and accordingly to give the requirement of raw materials.

refore, to justify the same. 2.||

A balanced chemical reaction indicating molecular weight of reactants and products with yield and accordingly to give the requirement of raw materials.
Generally, the direct reaction between Methyl Chloroformate and Isopropyl Alcohol is not the standard industrial synthesis route for manufacture Chloromethyl Isopropyl Carbonate, therefore, to justify the same.

Case No.	73 / NC/3/MEET/Oct/202526/9
Case Status	Case Deferred
Party Name	ACUTAAS CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006841AM25
RA File Number	52AX04000400 AM25
Licence No and<br>Date	5211012552/24/03/2025
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: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

E was requested to expedite his comments.**||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Case No.	74 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	USV PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006844AM25
RA File Number	03AX04006453 AM25
Licence No and<br>Date	0311042426/24/03/2025
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>Doxycycline Tablets, USP 50 mg 100<br>S((21,600 Bottles X 100 Per Bottles =<br>21,60,000 Tablets)<br>2160000<br>Numbers<br>1<br>Doxycycline USP<br>(Monohydrate)<br>116.327 kg.<br>Doxycycline Tablets, USP 100 MG 50<br>S((84,000 Bottles X 50 Per Bottles =<br>42,00,000 Tablets)<br>4200000<br>Numbers<br>2<br>Doxycycline USP<br>(Monohydrate)<br>452.382 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	75 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	TOPNOTCH CHEMICALS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006846AM25
RA File Number	03AX04006460 AM25
Licence No and<br>Date	0311042427/24/03/2025
Norms Committee Decision:

3/ MEET/ Oct/ 202526/ 9 and 14/10/2025| |HQ File Number|HQRNORM APPLY 00006846AM25| |RA File Number|03AX04006460 AM25| |Licence No and Date|0311042427/24/03/2025| |Norms Committee Decision:||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

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.
Halquinol 60%	1 kg.	1	8-Hydroxy Quinoline	0.462 kg.

Case No.	Case No.	76 / NC/3/MEET/Oct/202526/9	76 / NC/3/MEET/Oct/202526/9	76 / NC/3/MEET/Oct/202526/9	76 / NC/3/MEET/Oct/202526/9	76 / NC/3/MEET/Oct/202526/9
Case Status		Case Approved
Party Name		TOPNOTCH CHEMICALS PVT LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number		HQRNORM APPLY 00006849AM25
RA File Number		03AX04006544 AM25
Licence No and<br>Date		0311042441/24/03/2025
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.<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 9H FLUORENE 0.814 Kg. 2 DI N Butylamine 0.390 Kg. 3 Sodium Borohydride 0.040 Kg. 4 Para Chloro Benzaldehyde 0.336 Kg. Lumefantrine 1 Kg. 5 Di Methyl Formamide 0.555 Kg. RA concerned may take further necessary action as aer above decision of NC.||||per agenda and it was decided to fix ad-hoc norms under para 4.07 or as applied by the firm, whichever is less:-||| ||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.| |||||4|Para Chloro Benzaldehyde|0.336 Kg.| |||||5|Di Methyl Formamide|0.555 Kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

36 Kg.| |||||5|Di Methyl Formamide|0.555 Kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Case No.	77 / NC/3/MEET/Oct/202526/9
Case Status	Case Rejected
Party Name	ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006882AM25
RA File Number	03AX04006519 AM25
Licence No and<br>Date	0311042499/25/03/2025
Norms Committee Decision:<br>The firm was initially granted an Advance Authorisation for the export product_“MENTHANOL”<br>(4-Isopropyl Cyclohexyl Methanol)”_under Para 4.07 of the Handbook of Procedures (HBP).<br>However, as per Para 4.11(b) of the Foreign Trade Policy (FTP) 2023, products falling under the<br>category of perfume or perfumery compounds are ineligible for authorisation under Para 4.07 and<br>are mandatorily required to be processed under Para 4.06 of the HBP.<br>It was observed that the firm obtained the authorisation bymisdeclaring that its application<br>was covered under the provisions of Para 4.07, and has not furnished any technical<br>justification/information for the export product. Accordingly, the Committee found no merit in<br>fixing the norms and decided to reject the application.<br>The RA shall ensure that the said authorisation is regularised by recovery of applicable Customs<br>duty along with interest.

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

Case No.	78 / NC/3/MEET/Oct/202526/9
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006881AM25
RA File Number	05AX04004404 AM25
Licence No and<br>Date	0511031579/25/03/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

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.
Picloxydine Opthalmic Solution 10 ml<br>Vial (Piclosept) - (Each ml contains 0.5<br>mg of Picloxydine Dihydrochloride)	1 Number	1	Picloxydine<br>Dihydrochloride	5.10 mg.

Case No.	Case No.	79 / NC/3/MEET/Oct/202526/9	79 / NC/3/MEET/Oct/202526/9	79 / NC/3/MEET/Oct/202526/9	79 / NC/3/MEET/Oct/202526/9	79 / NC/3/MEET/Oct/202526/9
Case Status		Case Approved
Party Name		ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number		HQRNORM APPLY 00006854AM25
RA File Number		09AX04001173 AM25
Licence No and<br>Date		0911009278/25/03/2025
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 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.

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 Liraglutide (API- (Water Content- upto 10%, Acid Content- 0%, Ammonium content- 0.02%, Sodium Ion- 2.3%)=12.32%) 21.359 mg. 2 3.0 mL Pre - Crimped Glass Siliconized Cartridge (Cartridge EZ-Fill Nexa VB 3mL)(Packing Material) Net+1% with accountability BD Vystra Disposable Pen Body Net+1% with Liraglutide Injection 18 mg / 3 ml (6 mg / ml) ((Each 3 ml. contains Liraglutide 18 mg.) Fill Volume- 3.3 ml.) 1 Number 3||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Liraglutide Injection 18 mg / 3 ml (6 mg / ml) ((Each 3 ml. contains Liraglutide 18 mg.) Fill Volume- 3.3 ml.)|| 1 Number|1|Liraglutide (API- (Water Content- upto 10%, Acid Content- 0%, Ammonium content- 0.02%, Sodium Ion- 2.3%)=12.32%)|21.359 mg.| |||||2|3.0 mL Pre - Crimped Glass Siliconized Cartridge (Cartridge EZ-Fill Nexa VB 3mL)(Packing Material)|Net+1% with accountability| |||||3|BD Vystra Disposable Pen Body|Net+1% with|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

|3|BD Vystra Disposable Pen Body|Net+1% with|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Subassembly with purple Colour<br>Dose Button (VYSTRA BSA FR<br>PL 284C BTN 2685C<br>50 IU)(Packing Material)<br>accountability<br>4<br>BD Vystra Disposable Pen<br>Printed Cartridge Holder<br>(VYSTRA CARTRIDGE<br>HOLDER PRINTED 0.6-15)"<br>(Packing<br>Material)<br>Net+1% with<br>accountability<br>5<br>BD Vystra Disposable Pen Cap<br>(VYSTRA CAP PL MODERN<br>284C) (Packing Material)<br>Net+1% with<br>accountability<br>RA concerned may take further necessary action as per above decision of NC.				Subassembly with purple Colour<br>Dose Button (VYSTRA BSA FR<br>PL 284C BTN 2685C<br>50 IU)(Packing Material)	accountability
			4	BD Vystra Disposable Pen<br>Printed Cartridge Holder<br>(VYSTRA CARTRIDGE<br>HOLDER PRINTED 0.6-15)"<br>(Packing<br>Material)	Net+1% with<br>accountability
			5	BD Vystra Disposable Pen Cap<br>(VYSTRA CAP PL MODERN<br>284C) (Packing Material)	Net+1% with<br>accountability

DER PRINTED 0.6-15)" (Packing Material)|Net+1% with accountability| ||||5|BD Vystra Disposable Pen Cap (VYSTRA CAP PL MODERN 284C) (Packing Material)|Net+1% with accountability|

Case No.	80 / NC/3/MEET/Oct/202526/9
Case Status	Case Deferred
Party Name	KLJ PLASTICIZERS LIMITED.
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006891AM25
RA File Number	05AX04004375 AM25
Licence No and<br>Date	0511031584/26/03/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>Justification of low yield of 73.8 %<br>1.

Case No.	81 / NC/3/MEET/Oct/202526/9
Case Status	Case Deferred
Party Name	UNICHEM LABORATORIES LIMITED

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

ed| |Party Name|UNICHEM LABORATORIES LIMITED|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006892AM25
RA File Number	03AX04006204 AM25
Licence No and<br>Date	0311042351/26/03/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>It appears that there are 2 export items mixed together under one. Firm may be advised to get the Advanced<br>Authorisation amended to show each export item separately with corresponding import.

Case No.	82 / NC/3/MEET/Oct/202526/9
Case Status	Case Deferred
Party Name	ACUTAAS CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006906AM25
RA File Number	52AX04000392 AM25
Licence No and<br>Date	5211012634/26/03/2025
Norms Committee Decision:<br>The Committee decided to defer the case for next meeting.

NORM APPLY 00006906AM25| |RA File Number|52AX04000392 AM25| |Licence No and Date|5211012634/26/03/2025| |Norms Committee Decision: The Committee decided to defer the case for next meeting.||

Case No.	83 / NC/3/MEET/Oct/202526/9
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00006910AM25
RA File Number	03AX04006609 AM25
Licence No and<br>Date	0311042574/27/03/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Complete chemistry, Molecular weight and Percentage yield on molar basis.

Case No.	84 / NC/3/MEET/Oct/202526/9
Case Status	Case Deferred
Party Name	BENZO CHEM INDUSTRIES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00000062AM26
RA File Number	03AX04006774 AM25
Licence No and<br>Date	0311042786/02/04/2025

| |Meeting Number and Date|NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025| |HQ File Number|HQRNORM APPLY 00000062AM26| |RA File Number|03AX04006774 AM25| |Licence No and Date|0311042786/02/04/2025| |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:- A balanced chemical reaction indicating molecular weight of reactants and products, with yield and accordingly to give the requirement of raw materials. 1. Stoichiometric material balance on molar basis. 2. The commercial value of by-product, if any, formed during the process. 3.||

Case No.	85 / NC/3/MEET/Oct/202526/9
Case Status	Case Deferred
Party Name	BENZO CHEM INDUSTRIES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00000064AM26
RA File Number	03AX04006769 AM25
Licence No and<br>Date	0311042787/02/04/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>A balanced chemical reaction indicating molecular weight of reactants and products with yield and<br>accordingly to give the requirement of raw materials.<br>1.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

ive the requirement of raw materials. 1.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00405997AM26

Stoichiometric material balance on molar basis.
The commercial value of by-product, if any, formed during the process.

Case No.	86 / NC/3/MEET/Oct/202526/9
Case Status	Case Deferred
Party Name	LA CHANDRA PHARMALAB PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202526/ 9 and 14/10/2025
HQ File Number	HQRNORM APPLY 00000242AM26
RA File Number	08AX04000065 AM26
Licence No and<br>Date	0811014717/15/04/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>Complete chemical description of import item.<br>1.<br>Complete chemistry with molecular weight and percentage yield on molar basis.<br>2.<br>Certificate of Analysis (CoA) of imort item from foreign supplier.<br>3.

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Nov-2025 14:26:22 Reason: ramankumar@nic.in Location: DGFT(HQ)

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