IN FORCE Advance Authorisation

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Government of India / भारत सरकार

Ministry of Commerce and Industry / वािणज्य और उद्योग मंत्रालय Department of Commerce / वािणज्य िवभाग

Directorate General of Foreign Trade, Delhi / िवदेश व्यापार महािनदेशालय, िदल्ली

VANIJYA BHAWAN, AKBAR ROAD, CENTRAL DELHI, DELHI, 110011 / वािणज्य भवन, अकबर

रोड, नई िदल्ली Email Office : egtf-dgft@gov.in , Phone Office : 011-23062777

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Nov/202526/10 DATED: 14/11/2025

Minutes of the Norms Committee–3 Meeting No.NC/3/MEET/Nov/202526/10 dated 14/11/2025 under the Chairmanship of Shri Rakesh Kumar, Addl. DGFT for considering the cases/issues under Duty Exemption Scheme (Chapter-4) of the Foreign Trade Policy, 2023 pertaining to Chemical and Allied products falling under Chapter 29 and 30.

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

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

    The Norms Committee has taken decisions only with respect to technical aspect/ wastage norms.

Signature Not Verified Signature Not Verified Digitally Signed. Digitally signa, Name: RAMAN KUMAR( Deputy Name: RAMAN KUJAAR( Deputy DGFT ) DGFT ) Date: 08-Dec-2025 15:40:00 Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ) Location:Reason: ramaniagmar@nic.inDGFTTHQ)

This document has been digitally signed by Raman Kumar, Deputy DGFT,DGFT(HQ) on 08-Dec-2025.

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While redeeming the application, RAs should check that the applicant has fulfilled all requirements as prescribed in policy/procedure, including those in notifications, public notices and policy circulars issued from time to time or any other provisions under FTP/HBP for issuance of Advance Authorization and regularisation of the case.

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

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

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

    RAs shall also ensure that authorization is issued or redeemed based on the wastages/consumption as ratified by the Committee or as per wastages claimed in the application, whichever is less. In this regard, full compliance with the provisions of Para 4.12 of FTP, Para 4.16, Para 4.21, and Para 4.51 of HBP shall be made.

The following members were present in the meeting:-

S.No.	Name and Designation of Representatives	Department
1	Raman Kumar,Deputy DGFT	DGFT(HQ)
2	Skina Rani,FTDO	DGFT(HQ)
3	Dineshnarain Mathur,Technical Consultant	DGFT
4	Nand Lal,Technical Consultant	DGFT
5	Shaish Kumar,Technical Consultant	DGFT

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Nov/202526/10
Case Status	Case Approved
Party Name	FARMSON BASIC DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00001438AM26
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>Decision: The committee considered the case as per agenda and it has been observed that there is no<br>technical details, Drug Manufacturing Licence (DML) or any other relevant documents in support of import<br>items and their requirement. Hence, it was decided that RA may decide the norm as per SION A-344.

Case No.	Case No.	2 / NC/3/MEET/Nov/202526/10	2 / NC/3/MEET/Nov/202526/10	2 / NC/3/MEET/Nov/202526/10	2 / NC/3/MEET/Nov/202526/10	2 / NC/3/MEET/Nov/202526/10
Case Status		Case Approved
Party Name		ABBOTT HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number		HQRNORM APPLY 00002836AM26
RA File Number		NA
Licence No and<br>Date		NA
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms to enable them to obtain<br>Advance Authorization from concerned RA and it was decided to fix ad-hoc norms as per details given<br>below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.

tion from concerned RA and it was decided to fix ad-hoc norms as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Fenofibrate Micronized IH/Ph Eur 48.96 mg. Fenofibrate 48 mg tablets) (7,000,000 NOS) (Net Content:1) Fenofibrate Micronized IH/Ph Eur: 336.00 KGS 2) Sucrose PH.Euro: 341.194.00 KGS) 1 Number 2 Sucrose PH.Euro 145.57 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Fenofibrate 48 mg tablets) (7,000,000 NOS) (Net Content:1) Fenofibrate Micronized IH/Ph Eur: 336.00 KGS 2) Sucrose PH.Euro: 341.194.00 KGS)|| 1 Number|1|Fenofibrate Micronized IH/Ph Eur|48.96 mg.| |||||2|Sucrose PH.Euro|145.57 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

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|48.96 mg.| |||||2|Sucrose PH.Euro|145.57 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Fenofibrate 145 mg tablets)<br>(101015000 Nos) (Net Content:3)<br>Fenofibrate Micronized IH/Ph<br>Eur: 14647.175 KG S 4) Sucrose<br>PH.Euro: 14873.449 KGS)	<br> <br>1 Number	3	Fenofibrate Micronized	147.90 mg.
		4	Sucrose PH.Euro	146.45 mg.
Fenofibrate Bulk Granulate<br>(Net<br>Content:<br>5)<br>Fenofibrate<br>Micronized IH/Ph.Eur: 2099.4048<br>KG S 6) Sucrose Ph.Eur :<br>2069.376 KGS)	<br> <br> <br>1 Kg.	5	Fenofibrate Micronized	0.3155 kg.
		6	Sucrose Ph.Eur	0.3124 kg.

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

e Ph.Eur : 2069.376 KGS)| 1 Kg.|5|Fenofibrate Micronized|0.3155 kg.| ||||6|Sucrose Ph.Eur|0.3124 kg.|

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

Case No.	Case No.	3 / NC/3/MEET/Nov/202526/10	3 / NC/3/MEET/Nov/202526/10	3 / NC/3/MEET/Nov/202526/10	3 / NC/3/MEET/Nov/202526/10	3 / NC/3/MEET/Nov/202526/10
Case Status		Case Approved
Party Name		ZYDUS LIFESCIENCES LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number		HQRNORM APPLY 00003316AM26
RA File Number		NA
Licence No and Date		NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No.NC/3/MEET/Mar/202324/26 dated 22/03/2024 against DGFT (Hqr.) File No.<br>HQRNORMAPPLY00008565AM24, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.Import Items<br>Qty. allowed.<br>1<br>MEMANTINE<br>HYDROCHLORIDE<br>USP<br>7.14 mg.<br>2<br>SUGAR SPHERES (NON-PAREIL)<br>NF<br>30.60 mg.<br>MEMANTINE<br>HYDROCHLORIDE EXTENDED<br>RELEASE CAPSULES 7 MG<br>((ACTIVE PHARMACEUTICAL<br>1 Number
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

IL) NF 30.60 mg. MEMANTINE HYDROCHLORIDE EXTENDED RELEASE CAPSULES 7 MG ((ACTIVE PHARMACEUTICAL 1 Number||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||MEMANTINE HYDROCHLORIDE EXTENDED RELEASE CAPSULES 7 MG ((ACTIVE PHARMACEUTICAL||1 Number|1 |MEMANTINE HYDROCHLORIDE USP| 7.14 mg.| |||||2 |SUGAR SPHERES (NON-PAREIL) NF| 30.60 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

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INGREDIENT: MEMANTINE<br>HYDROCHLORIDE USP))		3<br>	HYPROMELLOSE 5 CPS 2910 USP	3.824 mg.
		4<br>	HYPROMELLOSE 3 CPS 2910 USP	3.06 mg.
		5<br>	TRIETHYL CITRATE NF	0.829 mg.
		6<br>	TALC PH EUR/USP	1.594 mg.
MEMANTINE<br>HYDROCHLORIDE EXTENDED<br>RELEASE CAPSULES 14 MG<br>((ACTIVE PHARMACEUTICAL<br>INGREDIENT: MEMANTINE<br>HYDROCHLORIDE USP))	1 Number	7<br> <br>	MEMANTINE<br>HYDROCHLORIDE<br>USP	<br>14.28 mg.
		8<br> <br>	SUGAR SPHERES (NON-PAREIL)<br>NF	<br>61.20 mg.
		9<br>	HYPROMELLOSE 5 CPS 2910 USP	7.648 mg.
		10<br>	HYPROMELLOSE 3 CPS 2910 USP	6.12 mg.
		11<br>	TRIETHYL CITRATE NF	1.658 mg.
		12<br>	TALC PH EUR/USP	3.188 mg.
MEMANTINE<br>HYDROCHLORIDE EXTENDED<br>RELEASE CAPSULES 21 MG<br>((ACTIVE PHARMACEUTICAL<br>INGREDIENT: MEMANTINE<br>HYDROCHLORIDE USP))	1 Number	13<br> <br>	MEMANTINE<br>HYDROCHLORIDE<br>USP	<br>21.42 mg.
		14<br> <br>	SUGAR SPHERES (NON-PAREIL)<br>NF	<br>91.80 mg.

VE PHARMACEUTICAL INGREDIENT: MEMANTINE HYDROCHLORIDE USP))|1 Number|13 |MEMANTINE HYDROCHLORIDE USP| 21.42 mg.| ||||14 |SUGAR SPHERES (NON-PAREIL) NF| 91.80 mg.| ||||15 |HYPROMELLOSE 5 CPS 2910 USP|11.472 mg.| ||||16 |HYPROMELLOSE 3 CPS 2910 USP|9.18 mg.| ||||17 |TRIETHYL CITRATE NF|2.487 mg.| ||||18 |TALC PH EUR/USP|4.782 mg.| ||MEMANTINE HYDROCHLORIDE EXTENDED|1 Number|19 |MEMANTINE HYDROCHLORIDE USP| 28.56 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

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|20 SUGAR SPHERES (NON-PAREIL) NF 122.40 mg. 21 HYPROMELLOSE 5 CPS 2910 USP 15.296 mg. 22 HYPROMELLOSE 3 CPS 2910 USP 12.24 mg. 23 TRIETHYL CITRATE NF 3.316 mg. RELEASE CAPSULES 28 MG ((ACTIVE PHARMACEUTICAL INGREDIENT: MEMANTINE HYDROCHLORIDE USP)) 24 TALC PH EUR/USP 6.376 mg. 25 MEMANTINE HYDROCHLORIDE USP 5.10 mg. 26 TALC PH EUR/USP 1.02 mg. 27 CROSCARMELLOSE SODIUM NF 5.61 mg. 28 DIBASIC CALCIUM PHOSPHATE DIHYDRATE USP 73.95 mg. MEMANTINE HYDROCHLORIDE TABLETS 5 MG ((ACTIVE PHARMACEUTICAL INGREDIENT: MEMANTINE HYDROCHLORIDE USP)) 1 Number 29 MAGNESIUM STEARATE PH.E/NF/JP 1.02 mg. 30 MEMANTINE HYDROCHLORIDE USP 10.20 mg. 31 TALC PH EUR/USP 2.04 mg. 32 CROSCARMELLOSE SODIUM NF 11.22 mg. 33 DIBASIC CALCIUM PHOSPHATE DIHYDRATE USP 147.90 mg. MEMANTINE HYDROCHL

RELEASE CAPSULES 28 MG<br>((ACTIVE PHARMACEUTICAL<br>INGREDIENT: MEMANTINE<br>HYDROCHLORIDE USP))		20<br> <br>	SUGAR SPHERES (NON-PAREIL)<br>NF	<br>122.40 mg.
		21<br>	HYPROMELLOSE 5 CPS 2910 USP	15.296 mg.
		22<br>	HYPROMELLOSE 3 CPS 2910 USP	12.24 mg.
		23<br>	TRIETHYL CITRATE NF	3.316 mg.
		24<br>	TALC PH EUR/USP	6.376 mg.
MEMANTINE<br>HYDROCHLORIDE TABLETS 5<br>MG ((ACTIVE<br>PHARMACEUTICAL<br>INGREDIENT: MEMANTINE<br>HYDROCHLORIDE USP))	1 Number	25<br> <br>	MEMANTINE<br>HYDROCHLORIDE<br>USP	<br>5.10 mg.
		26<br>	TALC PH EUR/USP	1.02 mg.
		27<br>	CROSCARMELLOSE SODIUM NF	5.61 mg.
		28<br> <br>	DIBASIC CALCIUM PHOSPHATE<br>DIHYDRATE USP	<br>73.95 mg.
		29<br> <br>	MAGNESIUM<br>STEARATE<br>PH.E/NF/JP	<br>1.02 mg.
MEMANTINE<br>HYDROCHLORIDE TABLETS 10<br>MG ((ACTIVE<br>PHARMACEUTICAL<br>INGREDIENT: MEMANTINE<br>HYDROCHLORIDE USP))	1 Number	30<br> <br>	MEMANTINE<br>HYDROCHLORIDE<br>USP	<br>10.20 mg.
		31<br>	TALC PH EUR/USP	2.04 mg.
		32<br>	CROSCARMELLOSE SODIUM NF	11.22 mg.
		33<br> <br>	DIBASIC CALCIUM PHOSPHATE<br>DIHYDRATE USP	<br>147.90 mg.

E HYDROCHLORIDE USP| 10.20 mg.| ||||31 |TALC PH EUR/USP|2.04 mg.| ||||32 |CROSCARMELLOSE SODIUM NF|11.22 mg.| ||||33 |DIBASIC CALCIUM PHOSPHATE DIHYDRATE USP| 147.90 mg.| ||||34 |MAGNESIUM STEARATE PH.E/NF/JP| 2.04 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Case No.	4 / NC/3/MEET/Nov/202526/10
Case Status	Case Approved
Party Name	PRIVI FINE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00003704AM26
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms to enable them to obtain<br>Advance Authorization from concerned RA and it was decided to fix ad-hoc norms as per details given<br>below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Cuminaldehyde<br>0.916 kg.<br>Cyclamen Aldehyde<br>1 kg.<br>2<br>Propionnaldehyde<br>0.360 kg.<br>RA concerned may take further necessary action as per above decision of NC.

ty. allowed. 1 Cuminaldehyde 0.916 kg. Cyclamen Aldehyde 1 kg. 2 Propionnaldehyde 0.360 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	5 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00004088AM26
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it has been observed that a potency correction exceeding 8% has<br>been claimed in the norm calculation.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Accordingly, it was decided to call the firm for a Personal Hearing before the Norms Committee to justify the claim and submit relevant supporting documents/information.

)

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Accordingly, it was decided to call the firm for a Personal Hearing before the Norms Committee to justify the claim and submit relevant supporting documents/information.

Case No.	6 / NC/3/MEET/Nov/202526/10
Case Status	Case Rejected
Party Name	HALEOS LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00005583AM25
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the firm’s request for a review of the ad-hoc norms. Upon examination, it was<br>observed that the firm had not furnished any substantive technical justification or supporting information to<br>warrant an enhancement of the existing norms. In the absence of any new material evidence or justification,<br>the Committee found no reasonable grounds to review or revise the norms. Accordingly, it was decided to<br>reject the request and maintain the status quo.

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.||

Case No.	7 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	WEXFORD LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00003783AM25
RA File Number	072404000382 AM14
Licence No and<br>Date	0710101548/23/01/2014
Norms Committee Decision:<br>The firm was called for Personal Hearing on 19/11/2025 through Video Conference, but the firm could not<br>appear before Norms Committee. It was decided to grant one more opportunity to the firm forPersonal<br>Hearing<br> with relevant documents/information.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

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ing with relevant documents/information.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Case No.	8 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	GLOBE TROTTERS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00004519AM25
RA File Number	039404000124 AM16
Licence No and<br>Date	0310796194/26/05/2015
Norms Committee Decision:<br>The representative of the firm appeared for the Personal Hearing and explained their case. During the<br>hearing, they sought additional input items beyond those originally declared and admitted to the same in<br>the meeting. This constitutes a case of misdeclaration.<br>Accordingly, the Norms Committee advised the Regional Authority to initiate action against the firm<br>under the FTDR Act for such misdeclaration.<br>The Committee also directed the firm to submit copies of the Bills of Entry pertaining to their imports. The<br>norms will be finalised based on the firm’s reply and the documents submitted.

Case No.	9 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00000262AM24
RA File Number	039404000295 AM18
Licence No and<br>Date	0310814908/31/07/2017
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

|RA File Number|039404000295 AM18| |Licence No and Date|0310814908/31/07/2017| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	10 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	WEXFORD LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00003782AM25

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

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RA File Number	072404000120 AM18
Licence No and<br>Date	0710111992/09/08/2017
Norms Committee Decision:<br>The firm was called for Personal Hearing on 19/11/2025 through Video Conference, but the firm could not<br>appear before Norms Committee. It was decided to grant one more opportunity to the firm forPersonal<br>Hearing<br>with relevant documents/information.

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

Case No.	11 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	GLOBE TROTTERS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00004505AM25
RA File Number	039404000713 AM19
Licence No and<br>Date	0310825212/26/11/2018
Norms Committee Decision:<br>The representative of the firm appeared for the Personal Hearing and explained their case. During the<br>hearing, they sought additional input items beyond those originally declared and admitted to the same in<br>the meeting. This constitutes a case of misdeclaration.<br>Accordingly, the Norms Committee advised the Regional Authority to initiate action against the firm<br>under the FTDR Act for such misdeclaration.<br>The Committee also directed the firm to submit copies of the Bills of Entry pertaining to their imports.<br>The norms will be finalized based on the firm’s reply and the documents submitted.

Case No.	12 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	KEVA FRAGRANCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	018205000499AM20
RA File Number	039404000373 AM20
Licence No and<br>Date	0310830887/07/08/2019
Norms Committee Decision:

Date|NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025| |HQ File Number|018205000499AM20| |RA File Number|039404000373 AM20| |Licence No and Date|0310830887/07/08/2019| |Norms Committee Decision:||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

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The firm was called for Personal Hearing on 19/11/2025 through Video Conference, but the firm could not appear before Norms Committee. It was decided to grant one more opportunity to the firm for Personal Hearing with relevant documents/information.

Case No.	13 / NC/3/MEET/Nov/202526/10
Case Status	Case Rejected
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00000048AM25
RA File Number	318304000087 AM20
Licence No and<br>Date	3110067548/30/09/2019
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it has been observed that the<br>firm vide e-mail dated 16/09/2025 has informed that they have withdraw the application from RA and<br>requested to withdrawa the application from portal. Therefore, it was decided to close the application of the<br>firm.

9/2025 has informed that they have withdraw the application from RA and requested to withdrawa the application from portal. Therefore, it was decided to close the application of the firm.||

Case No.	14 / NC/3/MEET/Nov/202526/10
Case Status	Case Rejected
Party Name	TOJO VIKAS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00005226AM25
RA File Number	052404000616 AM20
Licence No and<br>Date	0510413195/03/01/2020
Norms Committee Decision:<br>The firm was initially granted an Advance Authorisation for the export product_“Sclareolide”_<br>under Para 4.07 of the Handbook of Procedures (HBP). However, as per Para 4.11(b) of the<br>Foreign Trade Policy (FTP) 2023, products falling under the category of perfume or perfumery<br>compounds are ineligible for authorisation under Para 4.07 and are mandatorily required to be<br>processed under Para 4.06 of the HBP.<br>It was observed that the firm obtained the authorisation bymisdeclaring that its application

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

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

a 4.07** , and has not furnished any technical justification/information for the export product. Accordingly, the Committee found no merit in fixing the norms and decided to reject the application.

The RA shall ensure that the said authorisation is regularised by recovery of applicable Customs duty along with interest. Further, the RA should also submit a report on how this authorisation was issued under Para 4.07 of HBP, to the Chairperson of the Norms Committee and to PC-4 Section, DGFT Headquarters.

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

Case No.	15 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	OPES HEALTH CARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00006406AM25
RA File Number	082404000394 AM20
Licence No and<br>Date	0810147815/22/05/2020
Norms Committee Decision:<br>The Committee considered the firm’s request for a review of the ad-hoc norms and it has been observed<br>that Certificate of Analysis (CoA) submitted by the firm refers to 2016-17 whereas Advance Authorisation<br>is of 2022-21. Therefore, it was decided to call the following documents from the firm:<br>Revised Certificate of Analsysis (CoA) of import item relevant to present Advance Authorisation.<br>1.<br>Revised Production/consumption data duly certified by CA for the last three years.<br>2.

Revised Certificate of Analsysis (CoA) of import item relevant to present Advance Authorisation. 1. Revised Production/consumption data duly certified by CA for the last three years. 2.||

Case No.	16 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00003807AM25
RA File Number	039404000166 AM21
Licence No and<br>Date	0310836755/19/06/2020

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Norms Committee Decision:

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

Case No.	17 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	ALKALI METALS LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00005538AM25
RA File Number	09AA04009415 AM22
Licence No and<br>Date	0911001301/03/08/2021
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, it was<br>decided to call for following information/documents from the firm:-<br>Step wise manufacturing process.<br>1.<br>Complete chemical reactions with molecular and structural formula and molecular weights along<br>with stage wise percentage yields on molar basis.<br>2.<br>Complete technical details as per Annexure to Appendix-4E for chemical products.<br>3.<br>Stoichiometric balance between import and export on molar basis.<br>4.

e yields on molar basis. 2. Complete technical details as per Annexure to Appendix-4E for chemical products. 3. Stoichiometric balance between import and export on molar basis. 4.||

Case No.	18 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00005553AM25
RA File Number	05AA04070230 AM22
Licence No and<br>Date	0511004557/06/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearing<br>before Norms Committee to explain its case along with following information / documents from the firm:-<br>Statement of actual consumption of imported inputs for present Advance Authorisation and another<br>1.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Advance Authorisation No. 0511015715 dated 09.11.2022 certified by company Auditor and justification for any difference in the consumption norms. 2. Percentage recovery of Pentanol achieved now.

Case No.	19 / NC/3/MEET/Nov/202526/10
Case Status	Case Approved
Party Name	METROPOLITAN EXIMCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00001611AM26
RA File Number	03AA040108347 AM22
Licence No and<br>Date	0311007901/25/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 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>9-ETHYL CARBAZOLE<br>1 kg.<br>1<br>CARBAZOLE<br>1.01 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	20 / NC/3/MEET/Nov/202526/10
Case Status	Case Approved
Party Name	LAZERHEAD LIFESCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00006211AM25
RA File Number	09AA04012424 AM22
Licence No and<br>Date	0911001950/26/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 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: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Ovaplant 150 mcg<br>(Salmon Gonadotropin Releasing Hormone<br>Analogue Implant)<br>40000<br>Numbers<br>1<br>Salmon Gonadorelin<br>6.0 gm.<br>Ovaplant 250 mcg<br>(Salmon Gonadotropin Releasing Hormone<br>Analogue Implant)<br>44000<br>Numbers<br>2<br>Salmon Gonadorelin<br>11.0 gm.<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
	Ovaplant 150 mcg<br>(Salmon Gonadotropin Releasing Hormone<br>Analogue Implant)	<br>40000<br>Numbers	1	Salmon Gonadorelin	6.0 gm.
	Ovaplant 250 mcg<br>(Salmon Gonadotropin Releasing Hormone<br>Analogue Implant)	44000<br>Numbers	2	Salmon Gonadorelin	11.0 gm.

logue Implant)| 40000 Numbers|1|Salmon Gonadorelin|6.0 gm.| ||Ovaplant 250 mcg (Salmon Gonadotropin Releasing Hormone Analogue Implant)|44000 Numbers|2|Salmon Gonadorelin|11.0 gm.|

Case No.	Case No.	21 / NC/3/MEET/Nov/202526/10	21 / NC/3/MEET/Nov/202526/10	21 / NC/3/MEET/Nov/202526/10	21 / NC/3/MEET/Nov/202526/10	21 / NC/3/MEET/Nov/202526/10
Case Status		Case Approved
Party Name		PANACEA BIOTEC PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number		HQRNORM REVIW00005946AM24
RA File Number		05AX04000321 AM22
Licence No and<br>Date		0511007823/11/01/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Paclitaxel<br>102 kg.<br>2<br>Albumin Human USP<br>(25% Solution)<br>464.4 Litre<br>Paclitaxel (Protein-Bound Particles<br>for Injectable Suspension 100 mg)<br>100,000 Vials<br>3<br>Rubber Stopper<br>1,02000 Numbers
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Paclitaxel (Protein-Bound Particles<br>for Injectable Suspension 100 mg)		100,000 Vials	1	Paclitaxel	102 kg.
				2	Albumin Human USP<br>(25% Solution)	464.4 Litre
				3	Rubber Stopper	1,02000 Numbers

n-Bound Particles for Injectable Suspension 100 mg)||100,000 Vials|1|Paclitaxel|102 kg.| |||||2|Albumin Human USP (25% Solution)|464.4 Litre| |||||3|Rubber Stopper|1,02000 Numbers| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Case No.	22 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	SALVI CHEMICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00006380AM25
RA File Number	03AX04001943 AM23
Licence No and<br>Date	0311016208/08/07/2022
Norms Committee Decision:<br>The Committee considered the case and observed that firm is importing Soda Ash which is under policy<br>restriction. Accordingly Committee is decided to that RA will visit the premises of the factory and check<br>records of use of soda ash and send a report to this committee as well as PC-4.

cy restriction. Accordingly Committee is decided to that RA will visit the premises of the factory and check records of use of soda ash and send a report to this committee as well as PC-4.||

Case No.	23 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00004127AM25
RA File Number	03AX04002151 AM23
Licence No and<br>Date	0311016241/11/07/2022
Norms Committee Decision:<br>The firm was called for Personal Hearing on 19/11/2025 through Video Conference, but the firm could not<br>appear before Norms Committee. It was decided to grant one more opportunity to the firm for Personal<br>Hearingwith relevant documents/information.

Case No.	24 / NC/3/MEET/Nov/202526/10
Case Status	Case Approved
Party Name	SRF LIMITED

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Meeting Number<br>and Date	Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number		HQRNORM REVIW00005332AM25
RA File Number		05AX04001011 AM23
Licence No and<br>Date		0511013749/13/07/2022
Norms Committee Decision:
<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Dimethyl Formamide<br>0.950 kg.<br>2<br>Sodium Methoxide Powder<br>0.670 kg.<br>3<br>Acetonitrile<br>0.520 kg.<br>4<br>Tri Ethyl Amine (TEA)<br>0.350 kg.<br>3-DIFLUOROMETHYL-1-METHYL-<br>1H-PYRAZOLE-4-CARBOXYLIC<br>ACID<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

520 kg. 4 Tri Ethyl Amine (TEA) 0.350 kg. 3-DIFLUOROMETHYL-1-METHYL- 1H-PYRAZOLE-4-CARBOXYLIC ACID 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||3-DIFLUOROMETHYL-1-METHYL- 1H-PYRAZOLE-4-CARBOXYLIC ACID||1 kg.|1|Dimethyl Formamide|0.950 kg.| |||||2|Sodium Methoxide Powder|0.670 kg.| |||||3|Acetonitrile|0.520 kg.| |||||4|Tri Ethyl Amine (TEA)|0.350 kg.| |||||||| |||||5|Toluene|0.315 kg.| |||||||| |||||6|Mixed Hexanes|0.236 kg.| |||||||| |||||||| |||||7|N-Butanol|0.010 kg.| |||||||| |||||||| |||||8|Hydrazine Hydrate (100%)|0.4943 kg.| |||||||| |||||||| |||||9|Hydrazine Hydrate (64%)|0.7723 kg.| |||||10|Jumbo Bag 910 X 910 X 1000 MM|Relevant, as per Packing Policy and General Notes.| |||||11|Jumbo Bag 920 X 920 X 1200 MM|Relevant, as per Packing Policy and General Notes.| |||||12|Jumbo Bag 910 X 910 X 900|Relevant, as per| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

		MM	Packing Policy and
			General Notes.

Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

		MM	Packing Policy and
			General Notes.

Case No.	25 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	STERLING AUXILIARIES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00005178AM25
RA File Number	03AX04002204 AM23
Licence No and<br>Date	0311016388/15/07/2022
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, it was<br>decided to call for following information/documents from the firm:-<br>Percentage active content of each of export item.<br>1.<br>Specific name of import item ‘Escorene, MC1037 and M 19.<br>2.

Case No.	26 / NC/3/MEET/Nov/202526/10
Case Status	Case Approved
Party Name	ALIVUS LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00003339AM23
RA File Number	03AX04003267 AM23
Licence No and<br>Date	0311018114/24/09/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

s decided to revise ad-hoc norms as under:-||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Voriconazole	1 kg.	1	1R-10-Camphor Sulphonic Acid	1.01 kg.
		2	6-Ethyl-5-Fluro-4-Hydroxypyrimidine	3.30 kg.
		3	Acetic Acid Glacial	5.00 kg.
		4	Acetone	1.35 kg.
		5	Ethyl Acetate	6.47 kg.
		6	Iso Propyl Alcohol	1.62 kg.
		7	Methanol	0.74 kg.
		8	Methylene Chloride (MDC)	2.68 kg.
		9	Tetra Hydro Furan (THF)	9.38 kg.
		10	Tri Ethyl Amine	2.00 kg.

Case No.	27 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00005557AM25
RA File Number	03AX04003155 AM23
Licence No and<br>Date	0311018363/05/10/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearing

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

before Norms Committee to explain its case along with following justification:-

Silicon Dioxide (SiO₂) already given in the approved norms in line with Drug Manufacturing Licence (DML) for the export product. Why additional quantity of SiO₂ is applied for?

ustification:-

Silicon Dioxide (SiO₂) already given in the approved norms in line with Drug Manufacturing Licence (DML) for the export product. Why additional quantity of SiO₂ is applied for?

Case No.	28 / NC/3/MEET/Nov/202526/10
Case Status	Case Rejected
Party Name	CORAL DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00006318AM25
RA File Number	05AX04001818 AM23
Licence No and<br>Date	0511015160/06/10/2022
Norms Committee Decision:<br>The Committee considered the firm’s request for a review of the ad-hoc norms. Upon examination, it was<br>observed that the firm had not furnished any substantive technical justification or supporting information to<br>warrant an enhancement of the existing norms. In the absence of any new material evidence or justification,<br>the Committee found no reasonable grounds to review or revise the norms. Accordingly, it was decided to<br>reject the request and maintain the status quo.

Case No.	29 / NC/3/MEET/Nov/202526/10
Case Status	Case Approved
Party Name	PANACEA BIOTEC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00003221AM25
RA File Number	05AX04002301 AM23
Licence No and<br>Date	0511015737/10/11/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under:-

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

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

|Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Diphtheria Toxoid Bulk 99.05 Litre 2 Tetanus Toxoid Bulk 38.1 Litre 3 Pertussis Bulk 688.5 Litre 4 Aluminium Phosphate Gel 636.2 kg. 5 Electronic Temperature Data Logger 1300 Numbers 6 Rubber Stopper 10,10,000 Numbers 7 VVM Dot 14 10,15,000 Numbers 8 Ags Hb Purification Mabs Column 54 Litre Easyfive TT Vaccine DTwP- Hep B-Hib- Pentavalent Vaccine (Each vial of 5.0ml contains 10 dose) with Vaccine Vial Monitor 10,00,000 Vials 9 Tetanus Toxoid for Conjugation 49.2 Litre RA concerned may take further necessary action as per above decision of NC.|Export Product|Qty.|Sl. No.|Import Items|Qty.

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Easyfive TT Vaccine DTwP-<br>Hep B-Hib- Pentavalent<br>Vaccine (Each vial of 5.0ml<br>contains 10 dose) with Vaccine<br>Vial Monitor	10,00,000 Vials	1<br>	Diphtheria Toxoid Bulk	99.05 Litre
		2	Tetanus Toxoid Bulk	38.1 Litre
		3	Pertussis Bulk	688.5 Litre
		4	Aluminium Phosphate Gel	636.2 kg.
		5	Electronic<br>Temperature<br>Data<br>Logger	<br>1300 Numbers
		6	Rubber Stopper	10,10,000 Numbers
		7	VVM Dot 14	10,15,000 Numbers
		8	Ags Hb Purification Mabs Column	54 Litre
		9	Tetanus Toxoid for Conjugation	49.2 Litre

Case No.	30 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	JUBILANT INGREVIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00005825AM23
RA File Number	05AX04003069 AM23
Licence No and<br>Date	0511016941/19/01/2023
Norms Committee Decision:<br>The firm was called for Personal Hearing on 19/11/2025 through Video Conference, but the firm could not<br>appear before Norms Committee. It was decided to grant one more opportunity to the firm for Personal

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Hearing with relevant documents/information.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Hearing with relevant documents/information.

Case No.	31 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	SYNERGIA SCIENCES PRIVATE LIMITED

Meeting Number
<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00006312AM23
RA File Number	03AX04005369 AM23
Licence No and
Date	0311021429/14/02/2023
Norms Committee	Decision:
The Committee c<br><br>	onsidered the case as per agenda and it was decided to call the firm for attending<br>	Personal<br>
Hearing<br> before Norms Committee to explain its case along with detailed information that bifurcation in<br>quantity of export made from Alpha Picoline and from (3 Ethanol Pyridine+Butyal Chloroformate).

Case No.	32 / NC/3/MEET/Nov/202526/10
Case Status	Case Rejected
Party Name	TOJO VIKAS INTERNATIONAL PRIVATE LIMITED

Meeting Number
<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00005335AM25
RA File Number	05AX04003614 AM23
Licence No and
Date	0511018112/31/03/2023
Norms Committee	Decision:
The firm was	initially granted an Advance Authorisation for the export product_“Ambroxan”_
under Para 4.07 of the Handbook of Procedures (HBP).

e|0511018112/31/03/2023| |Norms Committee|Decision:| |The firm was|initially granted an Advance Authorisation for the export product_“Ambroxan”_| |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.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

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

4.07 of HBP, to the Chairperson of the Norms Committee and to PC-4 Section, DGFT Headquarters.

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

Case No.	33 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	NAVIN FLUORINE ADVANCED SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00006354AM25
RA File Number	03AX04006341 AM23
Licence No and<br>Date	0311022753/12/04/2023
Norms Committee Decision:
The case is under consideration and TE was requested to expedite his comments.

Case No.	34 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	HIKAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00001916AM26
RA File Number	03AX04000161 AM24
Licence No and<br>Date	0311022971/20/04/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearing
before Norms Committee to explain its case along with following information / documents from the firm:-
Complete and balanced chemistry showing molecular weight.<br>1.
Percentage yield on molar basis for each step.<br>2.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Molar requirement of reactants with technical justification.

. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Molar requirement of reactants with technical justification.
Justification for the requirement of import item No. 5 and 6.

Case No.	35 / NC/3/MEET/Nov/202526/10
Case Status	Case Rejected
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00006080AM25
RA File Number	05AX04000214 AM24
Licence No and<br>Date	0511018497/25/04/2023
Norms Committee Decision:<br>The Committee considered the firm’s request for a review of the ad-hoc norms. Upon examination, it was<br>observed that the firm had not furnished any substantive technical justification or supporting information to<br>warrant an enhancement of the existing norms. In the absence of any new material evidence or justification,<br>the Committee found no reasonable grounds to review or revise the norms. Accordingly, it was decided to<br>reject the request and maintain the status quo

w 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||

Case No.	36 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	AGRO SOLVENT PRODUCTS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00001107AM24
RA File Number	56AX04000449 AM23
Licence No and<br>Date	5611001909/25/05/2023
Norms Committee Decision:<br>The firm was called for Personal Hearing on 19/11/2025 through Video Conference, but the firm could not<br>appear before Norms Committee. It was decided to grant one more opportunity to the firm forPersonal<br>Hearing<br> with relevant documents/information.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

ng with relevant documents/information.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Case No.	37 / NC/3/MEET/Nov/202526/10
Case Status	Case Rejected
Party Name	CONNEX PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00005897AM25
RA File Number	26AX04000033 AM24
Licence No and<br>Date	2611000980/16/06/2023
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.

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.||

Case No.	38 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	PAYAL POLYPLAST PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00002939AM26
RA File Number	05AX04000851 AM24
Licence No and<br>Date	0511019523/26/06/2023
Norms Committee Decision:
The committee considered the request of firm for review of ad-hoc norms and as per the advice of the TE, it was
decided to call for	following information/documents from the firm:-
Complete chemistry, molecular weight and percentage yield and Stichometric balance on molar basis
submitted at the time of application.

Case No.	39 / NC/3/MEET/Nov/202526/10
Case Status	Case Rejected
Party Name	TOJO VIKAS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

|NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

HQ File Number	HQRNORM REVIW00005259AM25
RA File Number	05AX04001146 AM24
Licence No and<br>Date	0511020026/25/07/2023
Norms Committee Decision:
The firm was initially granted an Advance Authorisation for the export product_“Ambroxide”_
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.

P, 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.	40 / NC/3/MEET/Nov/202526/10
Case Status	Case Rejected
Party Name	KELVIN NATURAL MINT PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00004732AM24
RA File Number	05AX04001031 AM24
Licence No and<br>Date	0511019800/31/07/2023
Norms Committee Decision:
The committee considered the application of the firm and it has been observed that various opportunities
were given to firm but the firm has not appeared for personal hearing before committee to explain their
case, therefore, the committee decided to reject the application of the firm.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

ided to reject the application of the firm.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Case No.	41 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00004957AM24
RA File Number	03AX04002106 AM24
Licence No and<br>Date	0311026174/09/08/2023
Norms Committee Decision:
The firm was called for Personal Hearing on 19/11/2025, but the firm could not appear before Norms
Committee. It was decided to grant one more opportunity to the firm forPersonal Hearing<br>		with sample of
all import items.

Case No.	Case No.	41 / NC/3/MEET/Nov/202526/10	41 / NC/3/MEET/Nov/202526/10	41 / NC/3/MEET/Nov/202526/10	41 / NC/3/MEET/Nov/202526/10	41 / NC/3/MEET/Nov/202526/10	41 / NC/3/MEET/Nov/202526/10	41 / NC/3/MEET/Nov/202526/10	41 / NC/3/MEET/Nov/202526/10	41 / NC/3/MEET/Nov/202526/10	41 / NC/3/MEET/Nov/202526/10
Case Status		Case Deferred
Party Name		FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number
and Date		NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number		HQRNORM APPLY 00004957AM24
RA File Number		03AX04002106 AM24
Licence No and<br>Date		0311026174/09/08/2023

/ 10 and 14/11/2025|||||||||| |HQ File Number||HQRNORM APPLY 00004957AM24|||||||||| |RA File Number||03AX04002106 AM24|||||||||| |Licence No and Date||0311026174/09/08/2023|||||||||| ||||||||||||| |Norms Committee Decision: The firm was called for Personal Hearing on 19/11/2025, but the firm could not appear before Norms Committee. It was decided to grant one more opportunity to the firm forPersonal Hearing with sample of all import items.|||||||||||| ||||||||||||| ||||||||||||| ||||||||||||| ||||||||||||| |Case No.||42 / NC/3/MEET/Nov/202526/10|||||||||| |Case Status||Case Approved|||||||||| |Party Name||HIKAL LIMITED|||||||||| |Meeting Number|||||||||||| |and Date||NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025|||||||||| |HQ File Number||HQRNORM APPLY 00004972AM24|||||||||| |RA File Number||03AX04002023 AM24|||||||||| |Licence No and Date||0311026196/10/08/2023|||||||||| |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 Qty. Sl. No. Import Items Qty. allowed. 1 3-Picoline 0.170 kg. 2 Mesylchloride 0.247 kg. IKI-3106 (Cyclaniliprole) 1 kg. 3 Sodium sulfite 0.105 kg.|||||||||||| ||HBP Vol. I as per details given b|||elow or|as ap|plied by the fir||m, whichever is less:-|||| ||||||||||||| ||Export Product||Qt|y.|Sl|. No.|Impor|t Items|||Qty.

m sulfite 0.105 kg.|||||||||||| ||HBP Vol. I as per details given b|||elow or|as ap|plied by the fir||m, whichever is less:-|||| ||||||||||||| ||Export Product||Qt|y.|Sl|. No.|Impor|t Items|||Qty. allowed.| ||||||||||||| ||IKI-3106 (Cyclaniliprole)|||1 kg.||1|3-Pico|line|||0.170 kg.| ||||||||||||| |||||||2|Mesyl|chloride|||0.247 kg.| |||||||3|Sodium sulfite|||0.105 kg.|| ||||||||||||| |RA concerned may take further necessary action as per above decision of NC.||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Case No.	43 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	STANEX DRUGS AND CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00005456AM24
RA File Number	09AX04000507 AM24
Licence No and<br>Date	0911005765/05/09/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE, it was<br>decided to call for following information/documents from the firm:-<br>Technical Process flow diagram of manufacturing of Heparin Sodium Injection and Wastage<br>involved at each step.<br>1.<br>Batch manufacturing record and material issued and material reconciliation sheet for production of a<br>batch for Heparin Sodium Injection, duly signed by dealing QA/Executive/Manager.<br>2.<br>Justification of claiming 46% wastage.<br>3.

ed and material reconciliation sheet for production of a batch for Heparin Sodium Injection, duly signed by dealing QA/Executive/Manager. 2. Justification of claiming 46% wastage. 3.||

Case No.	44 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00005822AM24
RA File Number	03AX04002768 AM24
Licence No and<br>Date	0311027333/22/09/2023
Norms Committee Decision:<br>The firm was called for Personal Hearing on 19/11/2025, but the firm could not appear before Norms<br>Committee. It was decided to grant one more opportunity to the firm forPersonal Hearing<br> with sample of<br>all import items.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Case No.	45 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	NAVIN FLUORINE ADVANCED SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00006355AM25
RA File Number	03AX04002920 AM24
Licence No and<br>Date	0311027458/27/09/2023
Norms Committee Decision:
The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE, it was
decided to call for following information/documents from the firm:-
How many moles of acetaldoxime are used in chemical reaction.<br>1.

of ad-hoc norms and as per the advice of the TE, it was|| |decided to call for following information/documents from the firm:-|| |How many moles of acetaldoxime are used in chemical reaction. 1.|| |Balanced chemical reaction, stichometric balance on molar basis with percentage yield at every stage. 2.|| |Justification 3.|of low yield from crude to final product.| |Certificate of Analysis (CoA) of export item with percentage purity. 4.|| |Current production/consumption data duly certified by CA. 5.||

Case No.<br>46 / NC/3/MEET/Nov/202526/10
Case Status<br>Case Rejected
Party Name<br>MANKIND PHARMA LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number<br>HQRNORM REVIW00006171AM25
RA File Number<br>05AX04002383 AM24
Licence No and<br>Date<br>0511021940/07/11/2023
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.

Case No.	47 / NC/3/MEET/Nov/202526/10
Case Status	Case Rejected

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

526/10| |---|---| |Case Status|Case Rejected|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Party Name	TOJO VIKAS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00005245AM25
RA File Number	05AX04002297 AM24
Licence No and<br>Date	0511022013/10/11/2023
Norms Committee Decision:
The firm was initially granted an Advance Authorisation for the export product_“Ambroxan”_
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.

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.	48 / NC/3/MEET/Nov/202526/10
Case Status	Case Rejected
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00007039AM24
RA File Number	07AX04001335 AM24
Licence No and<br>Date	0711009794/24/11/2023
Norms Committee Decision:
The Committee considered the case as per the agenda, and it has been observed that the firm has paid the
duty and interest and also closed the licence through the concerned RA. Therefore, it was decided to close
the application of the firm.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

ed to close|| |the application of the firm.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Case No.	49 / NC/3/MEET/Nov/202526/10
Case Status	Case Approved
Party Name	CHEMPLAST SANMAR LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00007529AM24
RA File Number	04AX04000830 AM24
Licence No and<br>Date	0411006605/21/12/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/May/202526/3 dated 04/06/2025 against advance<br>authorization No. 0411007575 dated 13/06/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>D-Serine ((R)-2-amino-3-<br>hydroxypropanoic acid)<br>1.073 kg.<br>(4R)-2-oxooxazolidine-4-<br>carboxylic acid (COX)<br>1 kg.<br>2<br>Potassium methoxide 32% in<br>methanol<br>2.240 kg.<br>RA concerned may take further necessary action as per above decision of NC.

)-2-oxooxazolidine-4- carboxylic acid (COX) 1 kg. 2 Potassium methoxide 32% in methanol 2.240 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	50 / NC/3/MEET/Nov/202526/10
Case Status	Case Approved
Party Name	AMNEAL INJECTABLES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00007557AM24
RA File Number	08AX04001743 AM24
Licence No and<br>Date	0811010331/22/12/2023

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Mar/202425/19 dated 27/03/2025 against advance authorization No. 0811010589 dated 29/01/2024, 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.
Dexmedetomidine Hydrochloride in 0.9%<br>Sodium Chloride Injection 200 mcg/50 mL<br>(4 mcg/mL)	<br> <br>1 Number	1	Dexmedetomidine<br>Hydrochloride, USP	210.00 mcg.
Dexmedetomidine Hydrochloride in 0.9%<br>Sodium Chloride Injection 400 mcg/100<br>mL (4 mcg/mL)	<br> <br>1 Number	2	Dexmedetomidine<br>Hydrochloride, USP	420.00 mcg.
Dexmedetomidine Hydrochloride in 0.9%<br>Sodium Chloride Injection 200 mcg per 50<br>mL (4 mcg/mL)	<br> <br>1 Number	3	Dexmedetomidine<br>Hydrochloride, USP	210.00 mcg.
Dexmedetomidine Hydrochloride in 0.9%<br>Sodium Chloride Injection 400 mcg per<br>100 mL (4 mcg/mL)	<br> <br>1 Number	4	Dexmedetomidine<br>Hydrochloride, USP	420.00 mcg.

Case No.	51 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	JUBILANT INGREVIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00008210AM24
RA File Number	05AX04003445 AM24
Licence No and<br>Date	0511023507/30/01/2024
Norms Committee Decision:

3/ MEET/ Nov/ 202526/ 10 and 14/11/2025| |HQ File Number|HQRNORM APPLY 00008210AM24| |RA File Number|05AX04003445 AM24| |Licence No and Date|0511023507/30/01/2024| |Norms Committee Decision:||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Case No.	Case No.	52 / NC/3/MEET/Nov/202526/10	52 / NC/3/MEET/Nov/202526/10	52 / NC/3/MEET/Nov/202526/10	52 / NC/3/MEET/Nov/202526/10	52 / NC/3/MEET/Nov/202526/10
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number		HQRNORM APPLY 00008214AM24
RA File Number		34AX04000788 AM24
Licence No and<br>Date		3411004560/30/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No. NC/3/MEET/Aug/202526/7 dated 22/08/2025 against advance<br>authorization No. 3411003278 dated 24/01/2023,it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl.

24/01/2023**,**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. 1 Doxycycline Monohydrate USP 82.26 mg 2 Microcrystalline Cellulose (Avicel PH 301) 88.874 mg. 3 Sodium Starch Glycolate (Type A) (EXPLOTAB) 12.75 mg. 4 Povidone (Kollidon30 LP) 6.00 mg. 5 Microcrystalline Cellulose (Avicel PH 200 LM) 15.00 mg. 6 Colloidal Silicon Dioxide (Aerosil 200 Pharma) 1.088 mg. Doxycycline Caps. USP 75 mg. 1 Number||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Doxycycline Caps. USP 75 mg.||1 Number|1|Doxycycline Monohydrate USP|82.26 mg| |||||2|Microcrystalline Cellulose (Avicel PH 301)|88.874 mg.| |||||3|Sodium Starch Glycolate (Type A) (EXPLOTAB)|12.75 mg.| |||||4|Povidone (Kollidon30 LP)|6.00 mg.| |||||5|Microcrystalline Cellulose (Avicel PH 200 LM)|15.00 mg.| |||||6|Colloidal Silicon Dioxide (Aerosil 200 Pharma)|1.088 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

on Dioxide (Aerosil 200 Pharma)|1.088 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

		7	Magnesium Stearate (Vegetable<br>Source)	2.25 mg.
Doxycycline Caps. USP 100 mg	1 Number	8	Doxycycline Monohydrate USP	109.68 mg.
		9	Microcrystalline Cellulose<br>(Avicel PH 301)	118.498 mg.
		10	Sodium Starch Glycolate (Type<br>A) (EXPLOTAB)	17.00 mg.
		11	Povidone (Kollidon30 LP)	8.00 mg.
		12	Microcrystalline Cellulose<br>(Avicel PH 200 LM)	20.00 mg.
		13	Colloidal Silicon Dioxide<br>(Aerosil 200 Pharma)	1.45 mg.
		14	Magnesium Stearate (Vegetable<br>Source)	3.00 mg.

g.| ||||12|Microcrystalline Cellulose (Avicel PH 200 LM)|20.00 mg.| ||||13|Colloidal Silicon Dioxide (Aerosil 200 Pharma)|1.45 mg.| ||||14|Magnesium Stearate (Vegetable Source)|3.00 mg.|

Case No.	53 / NC/3/MEET/Nov/202526/10
Case Status	Case Approved
Party Name	RUBICON RESEARCH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00008260AM24
RA File Number	03AX04004795 AM24
Licence No and<br>Date	0311030581/31/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Potassium Chloride ER Tablets	1 Number	1	Potassium Chloride USP (40-200	<br>765.00 mg.
USP 10 m Eq (Net content of			CS)
Potassium Cl. is 17283 kg and of
Polyvinyl Acetate is 3456.60 kg)		2	Polyvinyl Acetate NF, Kollicoat	<br>150.00 mg.
			SR 30D Dispersion USP
Potassium Chloride ER Tablets	1 Number	3	Potassium Chloride USP (40-200	<br>1530.00 mg.
USP 20 mEq (Net content of			CS)
Potassium Cl. is 234679.50 kg and
of Polyvinyl Acetate is 39113.25		4	Polyvinyl Acetate NF, Kollicoat	<br>250.00 mg.
kg)			SR 30D

0| 1530.00 mg.| |USP 20 mEq (Net content of|||CS)|| |Potassium Cl. is 234679.50 kg and||||| |of Polyvinyl Acetate is 39113.25||4|Polyvinyl Acetate NF, Kollicoat| 250.00 mg.| |kg)|||SR 30D||

Case No.	54 / NC/3/MEET/Nov/202526/10
Case Status	Case Rejected
Party Name	TOJO VIKAS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00008274AM24
RA File Number	05AX04003478 AM24
Licence No and<br>Date	0511023580/01/02/2024
Norms Committee Decision:
The firm was initially granted an Advance Authorisation for the export product
_“Ambrox/Ambroxide”_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

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

fixing the norms and decided to reject the application.

y Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

fixing the norms and decided to reject the application.

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

Case No.	55 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	SPC LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00006369AM25
RA File Number	34AX04000824 AM24
Licence No and<br>Date	3411004576/05/02/2024
Norms Committee Decision:
The Committee reviewed the matter as per the agenda and noted that the firm has still not submitted the
reply to the Deficiency Letter as previously requested. Accordingly, the Committee decided to issue a
further reminder to the firm to submit the reply without delay.

till not submitted the|| |reply to the Deficiency Letter as previously requested. Accordingly, the Committee decided to issue a|| |further reminder to the firm to submit the reply without delay.||

Case No.	56 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	ACUTAAS CHEMICALS LIMITED

Meeting Number
<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00008367AM24
RA File Number	52AX04000336 AM24
Licence No and
Date	5211007280/06/02/2024
Norms Committee	Decision:
The Committee c<br><br>	onsidered the case as per agenda and it was decided to call the firm for attending<br>	Personal<br>
Hearing<br> before Norms Committee to explain its case along with relevant information / documents		from the

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

firm.

firm.	firm.

Case No.	57 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	NAVIN FLUORINE ADVANCED SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00006356AM25
RA File Number	03AX04004580 AM24
Licence No and<br>	0311031163/14/02/2024
Date
Norms Committee	Decision:
The committee co	nsidered the request of firm for fixation of ad-hoc norms and as per the advice of the TE it was
<br>decided to call for	,<br>following information/documents from the firm:-

How many moles of acetaldoxime are used in chemical reaction?<br>I.<br>Balanced chemical reaction, stichometric balance on molar basis with percentage yield at every stage.<br>II.<br>Justification of low yield from crude to final product.<br>III.<br> <br>
Certificate of Analysis (CoA) of export item with percentage purity.<br>IV.<br>Current production/consumption data duly certified by CA.<br>V.



Case No.	58 / NC/3/MEET/Nov/202526/10
Case Status	Case Approved
Party Name	SHARP MINT LIMITED

Meeting Number
<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00008852AM24
RA File Number	05AX04003809 AM24

Licence No and<br>Date	0511024175/01/03/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

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: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Menthol Crystals	1 kg.	1	Menthol Laevo Dist	1.02 kg.

Case No.	59 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	SRI KRISHNA PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00008937AM24
RA File Number	09AX04001083 AM24
Licence No and<br>Date	0911006881/06/03/2024
Norms Committee Decision:
The case is under consideration and TE was requested to expedite his comments.

Case No.	Case No.	60 / NC/3/MEET/Nov/202526/10
Case Status		Case Approved
Party Name		AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ	File Number	HQRNORM APPLY 00008940AM24
RA File Number		09AX04001061 AM24
Licence No and Date		0911006884/06/03/2024
Norms Committee Decision:
The Committee considered		the case as per agenda and it was	decided to fix ad-hoc norms under Para 4.07
of HBP Vol. I as per details		given below or as applied by the firm, whichever is less:-
	Export Product		Qty.	Sl.

se 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.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

N(2(4((4fluorobenzyl)carbamoyl)	1	Dimethyl	acetylene	<br>2.50 kg.
5hydroxy1methyl6oxo1,6dihydropyrimidin2yl)propan2yl)		dicarboxylate
5methyl1,3,4oxadiazole2carboxamide
	2	4-Flouro	benzyl	<br>0.62 kg.
		amine
	3	Methanol		7.74 kg.
	4	Acetic acid		3.017 kg.

Case No.	61 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00009103AM24
RA File Number	03AX04005671 AM24
Licence No and<br>Date	0311032149/14/03/2024
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal
Hearing<br> before Norms Committee to explain its case along with sample of all import items.

ittee considered the case as per agenda and it was decided to call the firm for attendingPersonal|| |Hearing before Norms Committee to explain its case along with sample of all import items.||

Case No.	62 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	GALAXY SURFACTANTS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00004387AM25
RA File Number	03AX04006008 AM24
Licence No and<br>Date	0311032549/27/03/2024
Norms Committee Decision:

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

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

Certificate of Analysis (CoA) report of export item indicating active content.
How the product is different from the export item indicated at SION No. A-3574.

on/documents from the firm:-

Certificate of Analysis (CoA) report of export item indicating active content.
How the product is different from the export item indicated at SION No. A-3574.

Case No.	63 / NC/3/MEET/Nov/202526/10
Case Status	Case Rejected
Party Name	USV PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00005650AM25
RA File Number	03AX04000029 AM25
Licence No and<br>Date	0311032850/05/04/2024
Norms Committee Decision:<br>The Committee considered the firm’s request for a review of the ad-hoc norms. Upon examination, it was<br>observed that the firm had not furnished any substantive technical justification or supporting information to<br>warrant an enhancement of the existing norms. In the absence of any new material evidence or justification,<br>the Committee found no reasonable grounds to review or revise the norms. Accordingly, it was decided to<br>reject the request and maintain the status quo.

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.||

Case No.	64 / NC/3/MEET/Nov/202526/10
Case Status	Case Rejected
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00004138AM25
RA File Number	03AX04000426 AM25
Licence No and<br>Date	0311033410/29/04/2024
Norms Committee Decision:<br>The Committee considered the firm’s request for a review of the ad-hoc norms. Upon examination, it was<br>observed that the firm had not furnished any substantive technical justification or supporting information to<br>warrant an enhancement of the existing norms. In the absence of any new material evidence or justification,

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

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.

Location: DGFT(HQ)

UDIN00439229AM26

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.	65 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	INNOVARE LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00000484AM25
RA File Number	09AX04001160 AM24
Licence No and<br>Date	0911007159/30/04/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE, it was<br>decided to call for following information/documents from the firm:-<br>Function/application of import chemicals which are not the part of chemical reaction and it requirement with<br>calculation and past data.<br>1.<br>In chemical reaction, to indicate Serial number of import item with description (as per the license) below the<br>reactants and if, indigenous item, then to indicate accordingly.<br>2.<br>Concentration of_New Pentyl Zin Bromide Solution in THF_(Import Sl.No.1).<br>3.<br>To give overall yield of each import chemical with justification.<br>4.<br>End use of export item.<br>5.

2. Concentration of_New Pentyl Zin Bromide Solution in THF_(Import Sl.No.1). 3. To give overall yield of each import chemical with justification. 4. End use of export item. 5.||

Case No.	66 / NC/3/MEET/Nov/202526/10
Case Status	Case Approved
Party Name	JALAQUA INTERNATIONAL LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00000722AM25
RA File Number	52AX04000032 AM25
Licence No and<br>Date	5211008159/15/05/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Corrosive Solid, Basic, Organic, N.O.S<br>(ChloramineT) (Chloramine Dihydrates)	<br>1 kg.	1	Trichloroisocyanuric Acid	0.636 kg.

ct	Qty.	Sl. No.	Import Items	Qty. allowed.
Corrosive Solid, Basic, Organic, N.O.S<br>(ChloramineT) (Chloramine Dihydrates)	<br>1 kg.	1	Trichloroisocyanuric Acid	0.636 kg.

Case No.	67 / NC/3/MEET/Nov/202526/10
Case Status	Case Rejected
Party Name	USV PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM REVIW00005651AM25
RA File Number	03AX04001364 AM25
Licence No and<br>Date	0311034851/24/06/2024
Norms Committee Decision:<br>The Committee considered the firm’s request for a review of the ad-hoc norms. Upon examination, it was<br>observed that the firm had not furnished any substantive technical justification or supporting information to<br>warrant an enhancement of the existing norms. In the absence of any new material evidence or justification,<br>the Committee found no reasonable grounds to review or revise the norms. Accordingly, it was decided to<br>reject the request and maintain the status quo.

Case No.	68 / NC/3/MEET/Nov/202526/10
Case Status	Case Approved
Party Name	PANACEA BIOTEC PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00001565AM25
RA File Number	05AX04000957 AM25
Licence No and<br>Date	0511026325/26/06/2024
Norms Committee Decision:

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

6325/26/06/2024| |Norms Committee Decision:||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

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

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Paclitaxel (Protein-Bound Particles<br>for Injectable Suspension 100 mg)<br>Pacliall	35734 Vials	1	Albumin Human USP<br>(25% Solution)	166 Litre

Case No.	Case No.	69 / NC/3/MEET/Nov/202526/10	69 / NC/3/MEET/Nov/202526/10	69 / NC/3/MEET/Nov/202526/10	69 / NC/3/MEET/Nov/202526/10	69 / NC/3/MEET/Nov/202526/10
Case Status		Case Approved
Party Name		JUBILANT GENERICS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number		HQRNORM APPLY 00001713AM25
RA File Number		05AX04001073 AM25
Licence No and<br>Date		0511026456/03/07/2024
Norms Committee Decision:<br>The Committee 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. Paroxetine Hydrochloride 10mg Tablets 1 Number 1 Paroxetine Hydrochloride Hemihydrate 11.608 mg. Paroxetine Hydrochloride 20mg Tablets 1 Number 2 Paroxetine Hydrochloride Hemihydrate 23.216 mg. Paroxetine Hydrochloride 30mg Tablets 1 Number 3 Paroxetine Hydrochloride Hemihydrate 34.823 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Paroxetine Hydrochloride 10mg Tablets|| 1 Number|1|Paroxetine Hydrochloride Hemihydrate|11.608 mg.| ||Paroxetine Hydrochloride 20mg Tablets|| 1 Number|2|Paroxetine Hydrochloride Hemihydrate|23.216 mg.| ||Paroxetine Hydrochloride 30mg Tablets|| 1 Number|3|Paroxetine Hydrochloride Hemihydrate|34.823 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Paroxetine Hydrochloride	40mg	<br>1	Number	4	Paroxetine Hydrochloride	46.431 mg.
Tablets					Hemihydrate

ar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Paroxetine Hydrochloride	40mg	<br>1	Number	4	Paroxetine Hydrochloride	46.431 mg.
Tablets					Hemihydrate

Case No.	70 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00001763AM25
RA File Number	31AX04000098 AM25
Licence No and<br>Date	3111003647/05/07/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE, it was<br>decided to call for following information/documents from the firm:-<br>To give overall quantity of each chemical based on theoretical yield.<br>1.<br>The theoretical value of by-product of caustic soda used by own industry.<br>2.<br>Reason for using different type of solvent Methanol, Methylene Dichloride and Acetone.<br>3.<br>To give weight of Hydrogen gas in kg. terms.<br>4.

Case No.	71 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	ACUTAAS CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00001820AM25
RA File Number	52AX04000089 AM25
Licence No and<br>Date	5211008812/08/07/2024
Norms Committee Decision:

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

8812/08/07/2024| |Norms Committee Decision:||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

The firm was called for Personal Hearing on 19/11/2024 through Video Conference, but the firm could not appear before Norms Committee. It was decided to grant one more opportunity to the firm for Personal Hearing with relevant documents/information.

Case No.	72 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00001961AM25
RA File Number	03AX04001867 AM25
Licence No and<br>Date	0311035566/16/07/2024
Norms Committee Decision:<br>The firm was called for Personal Hearing on 19/11/2025, but the firm could not appear before Norms<br>Committee. It was decided to grant one more opportunity to the firm forPersonal Hearing<br> with sample of<br>all import items

earing on 19/11/2025, but the firm could not appear before Norms Committee. It was decided to grant one more opportunity to the firm forPersonal Hearing with sample of all import items||

Case No.	Case No.	73 / NC/3/MEET/Nov/202526/10	73 / NC/3/MEET/Nov/202526/10	73 / NC/3/MEET/Nov/202526/10	73 / NC/3/MEET/Nov/202526/10	73 / NC/3/MEET/Nov/202526/10
Case Status		Case Approved
Party Name		DINAKARA LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number		HQRNORM APPLY 00001982AM25
RA File Number		09AX04000270 AM25
Licence No and<br>Date		0911007602/18/07/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Methallyl chloride<br>(1-Methylcyclopropene (1-MCP))<br>1 kg.<br>1<br>0.0891 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	(1-Methylcyclopropene (1-MCP))		1 kg.	1	Methallyl chloride	0.0891 kg.

1-Methylcyclopropene (1-MCP)) 1 kg. 1 0.0891 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||(1-Methylcyclopropene (1-MCP))||1 kg.|1|Methallyl chloride|0.0891 kg.|

Case No.	Case No.	73 / NC/3/MEET/Nov/202526/10	73 / NC/3/MEET/Nov/202526/10	73 / NC/3/MEET/Nov/202526/10	73 / NC/3/MEET/Nov/202526/10	73 / NC/3/MEET/Nov/202526/10
Case Status		Case Approved
Party Name		DINAKARA LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number		HQRNORM APPLY 00001982AM25
RA File Number		09AX04000270 AM25
Licence No and<br>Date		0911007602/18/07/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Methallyl chloride<br>(1-Methylcyclopropene (1-MCP))<br>1 kg.<br>1<br>0.0891 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	(1-Methylcyclopropene (1-MCP))		1 kg.	1	Methallyl chloride	0.0891 kg.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

	(3-CMP))
2	Sonneborn Double Blandol	0.090 kg.
	white Mineral oil
3	alpha Cyclodextrin	0.957 kg.

n: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

	(3-CMP))
2	Sonneborn Double Blandol	0.090 kg.
	white Mineral oil
3	alpha Cyclodextrin	0.957 kg.

Case No.	74 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00001994AM25
RA File Number	03AX04001885 AM25
Licence No and<br>Date	0311035597/18/07/2024
Norms Committee Decision:<br>The firm was called for Personal Hearing on 19/11/2025, but the firm could not appear before Norms<br>Committee. It was decided to grant one more opportunity to the firm forPersonal Hearing<br> with sample of<br>all import items.

Case No.	75 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	JUBILANT INGREVIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00002279AM25
RA File Number	05AX04001164 AM25
Licence No and<br>Date	0511026980/02/08/2024
Norms Committee Decision:

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

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

Case No.	76 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	MEDIPRAT INTERNATIONAL (INDIA)
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00002899AM25
RA File Number	05AX04001556 AM25
Licence No and<br>Date	0511027587/06/09/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE, it was<br>decided to call for following information/documents from the firm:-<br>Process flow of manufacturing export product and stepwise wastage incurred in the manufacturing.<br>1.<br>Certificate of Analysis (CoA) for imported input products.<br>2.

Case No.	Case No.	77 / NC/3/MEET/Nov/202526/10	77 / NC/3/MEET/Nov/202526/10	77 / NC/3/MEET/Nov/202526/10	77 / NC/3/MEET/Nov/202526/10	77 / NC/3/MEET/Nov/202526/10
Case Status		Case Approved
Party Name		KALPSUTRA GUJARAT
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number		HQRNORM APPLY 00002933AM25
RA File Number		34AX04000467 AM25
Licence No and<br>Date		3411005382/09/09/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol.

|Licence No and Date||3411005382/09/09/2024||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Undecylenic Aldehyde 1 kg. 1 Undecylenic Acid 1.30 kg.

Case No.	Case No.	78 / NC/3/MEET/Nov/202526/10	78 / NC/3/MEET/Nov/202526/10	78 / NC/3/MEET/Nov/202526/10	78 / NC/3/MEET/Nov/202526/10	78 / NC/3/MEET/Nov/202526/10
Case Status		Case Approved
Party Name		AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number		HQRNORM APPLY 00002984AM25
RA File Number		09AX04000283 AM25
Licence No and<br>Date		0911007924/11/09/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.

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 Guanine 3.00 kg. 2 CBZ -L-Valine 2.07 kg. 3 Dimethyl formamide 13.00 kg. 4 Dimethyl sulfoxide 2.82 kg. 5 Isopropyl alcohol 5.00 kg. 6 Trimethyl orthoacetate 2.92 kg. Valganciclovir Hydrochloride USP 1 kg. 7 1,3-Diacetoxy-2-(acetoxymethoxy) propane 2.15 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Valganciclovir Hydrochloride USP||1 kg.|1|Guanine|3.00 kg.| |||||2|CBZ -L-Valine|2.07 kg.| |||||3|Dimethyl formamide|13.00 kg.| |||||4|Dimethyl sulfoxide|2.82 kg.| |||||5|Isopropyl alcohol|5.00 kg.| |||||6|Trimethyl orthoacetate|2.92 kg.| |||||7|1,3-Diacetoxy-2-(acetoxymethoxy) propane|2.15 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

toxy-2-(acetoxymethoxy) propane|2.15 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Case No.	Case No.	79 / NC/3/MEET/Nov/202526/10	79 / NC/3/MEET/Nov/202526/10	79 / NC/3/MEET/Nov/202526/10	79 / NC/3/MEET/Nov/202526/10	79 / NC/3/MEET/Nov/202526/10
Case Status		Case Approved
Party Name		GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number		HQRNORM APPLY 00002995AM25
RA File Number		03AX04002886 AM25
Licence No and<br>Date		0311037072/11/09/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of 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 Clindamycin Phosphate USP 25.50 kg. Clindamycin & Benzoyl Peroxide Gel 1% / 5% ( Pack Size 25gm) 100000 Numbers 2 Hydrous Benzoyl Peroxide USP 127.5 kg. 3 Clindamycin Phosphate USP 35.70 kg. Clindamycin & Benzoyl Peroxide Gel 1% / 5% ( Pack Size 35 gm ) 100000 Numbers 4 Hydrous Benzoyl Peroxide USP 178.50 kg. 5 Clindamycin Phosphate USP 51.00 kg. Clindamycin & Benzoyl Peroxide Gel 1% / 5% ( Pack Size 50 gm) 100000 Numbers 6 Hydrous Benzoyl Peroxide USP 255.00 kg. Clindamycin Phosphate Gel 1% (Pack Size 30 gm) 10000 Numbers 7 Clindamycin Phosphate USP 3.06 kg. Clindamycin Phosphate Gel 1% (Pack Size 60 gm) 10000 Numbers 8 Clindamycin Phosphate USP 6.12 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.

hosphate USP 3.06 kg. Clindamycin Phosphate Gel 1% (Pack Size 60 gm) 10000 Numbers 8 Clindamycin Phosphate USP 6.12 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Clindamycin & Benzoyl Peroxide Gel 1% / 5% ( Pack Size 25gm)|| 100000 Numbers|1|Clindamycin Phosphate USP|25.50 kg.| |||||2|Hydrous Benzoyl Peroxide USP|127.5 kg.| ||Clindamycin & Benzoyl Peroxide Gel 1% / 5% ( Pack Size 35 gm )|| 100000 Numbers|3|Clindamycin Phosphate USP|35.70 kg.| |||||4|Hydrous Benzoyl Peroxide USP|178.50 kg.| ||Clindamycin & Benzoyl Peroxide Gel 1% / 5% ( Pack Size 50 gm)|| 100000 Numbers|5|Clindamycin Phosphate USP|51.00 kg.| |||||6|Hydrous Benzoyl Peroxide USP|255.00 kg.| ||Clindamycin Phosphate Gel 1% (Pack Size 30 gm)|| 10000 Numbers|7|Clindamycin Phosphate USP|3.06 kg.| ||Clindamycin Phosphate Gel 1% (Pack Size 60 gm)|| 10000 Numbers|8|Clindamycin Phosphate USP|6.12 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Numbers|8|Clindamycin Phosphate USP|6.12 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Adapalene & Benzoyl Peroxide Gel<br>0.1% / 2.5% (Pack Size 45 gm)<br>120000<br>Numbers<br>9<br>Hydrous Benzoyl Peroxide USP<br>137.70 kg.<br>Deriva CO Gel 0.1%/2.5% ZA<br>(Adapalene & Benzoyl Peroxide Gel<br>0.1% / 2.5%) (Pack Size 45 gm)<br>100000<br>Numbers<br>10<br>Hydrous Benzoyl Peroxide USP<br>114.75 kg.<br>Deriva BPO Gel 0.1%/2.5% SA<br>(Adapalene & Benzoyl Peroxide Gel<br>0.1% / 2.5%) (Pack Size 45 gm)<br>5128<br>Numbers<br>11<br>Hydrous Benzoyl Peroxide USP<br>5.885 kg.<br>Deriva BPO Gel 0.1%/2.5% SA<br>(Adapalene & Benzoyl Peroxide Gel<br>0.1% / 2.5%) (Pack Size 45 gm)<br>5200<br>Numbers<br>12<br>Hydrous Benzoyl Peroxide USP<br>5.967 kg.<br>Clindamycin Phosphate Foam 1%<br>(Pack Size 50 gm)<br>100000<br>Numbers<br>13<br>Clindamycin Phosphate USP<br>51.00 kg.<br>Clindamycin Phosphate Foam 1%<br>(Pack Size 100 gm)<br>100000<br>Numbers<br>Clindamycin Phosphate USP<br>102.00 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Adapalene & Benzoyl Peroxide Gel<br>0.1% / 2.5% (Pack Size 45 gm)	<br>120000<br>Numbers	9	Hydrous Benzoyl Peroxide USP	137.70 kg.
	Deriva CO Gel 0.1%/2.5% ZA<br>(Adapalene & Benzoyl Peroxide Gel<br>0.1% / 2.5%) (Pack Size 45 gm)	<br> <br>100000<br>Numbers	10	Hydrous Benzoyl Peroxide USP	114.75 kg.

.| |---|---|---|---|---|---| ||Deriva CO Gel 0.1%/2.5% ZA (Adapalene & Benzoyl Peroxide Gel 0.1% / 2.5%) (Pack Size 45 gm)| 100000 Numbers|10|Hydrous Benzoyl Peroxide USP|114.75 kg.| ||Deriva BPO Gel 0.1%/2.5% SA (Adapalene & Benzoyl Peroxide Gel 0.1% / 2.5%) (Pack Size 45 gm)| 5128 Numbers|11|Hydrous Benzoyl Peroxide USP|5.885 kg.| ||Deriva BPO Gel 0.1%/2.5% SA (Adapalene & Benzoyl Peroxide Gel 0.1% / 2.5%) (Pack Size 45 gm)| 5200 Numbers|12|Hydrous Benzoyl Peroxide USP|5.967 kg.| ||Clindamycin Phosphate Foam 1% (Pack Size 50 gm)| 100000 Numbers|13|Clindamycin Phosphate USP|51.00 kg.| ||Clindamycin Phosphate Foam 1% (Pack Size 100 gm)| 100000 Numbers||Clindamycin Phosphate USP|102.00 kg.|

Case No.	80 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	METROCHEM API PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00003039AM25
RA File Number	09AX04000248 AM25
Licence No and<br>Date	0911007949/13/09/2024
Norms Committee Decision:<br>The representative of the firm appeared for the personal hearing and explained their case. However, the<br>firm has admitted in the meeting that input at Sl. No.3 for the manufacture of the export product is not<br>required. This constitutes a case of misdeclaration.<br>Accordingly, the Committee decided to fix the norms on the basis of the technical data and the

anufacture of the export product is not required. This constitutes a case of misdeclaration. Accordingly, the Committee decided to fix the norms on the basis of the technical data and the||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

reply/submission made by the firm.The firm is also asked to submit bill of entries for imported items.

The Committee further directed the Regional Authority (RA) to initiate appropriate action against the firm under the provisions of the Foreign Trade (Development & Regulation) Act, 1992 and the rules made thereunder for the misdeclaration.

Case No.	Case No.	81 / NC/3/MEET/Nov/202526/10	81 / NC/3/MEET/Nov/202526/10	81 / NC/3/MEET/Nov/202526/10	81 / NC/3/MEET/Nov/202526/10	81 / NC/3/MEET/Nov/202526/10
Case Status		Case Approved
Party Name		RUBICON RESEARCH LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number		HQRNORM APPLY 00003195AM25
RA File Number		03AX04002984 AM25
Licence No and<br>Date		0311037289/20/09/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.

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 1.95% Nitroglycerin on Lactose, USP 15.692 mg. 2 Lactose Monohydrate NF 12.912 mg. Nitroglycerin Sublingual Tablets 0.3 mg (Net content of input item 1.95% Nitroglycerin on Lactose, USP is 54.16 kgs & Lactose Monohydrate NF 45.45 kgs & Sodium Starch Glycolate NF 12.32 kgs )) 1 Number 3 Sodium Starch Glycolate NF 3.50 mg. 4 1.95% Nitroglycerin on Lactose, USP 20.923 mg. 5 Lactose Monohydrate NF 7.784 mg. Nitroglycerin Sublingual Tablets 0.4 mg (Net content of input item 1.95% Nitroglycerin on Lactose, USP is 573.55 kgs & Lactose Monohydrate NF 217.64 kgs & Sodium Starch Glycolate NF 97.86 kgs )) 1 Number 6 Sodium Starch Glycolate NF 3.50 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.

& Lactose Monohydrate NF 217.64 kgs & Sodium Starch Glycolate NF 97.86 kgs )) 1 Number 6 Sodium Starch Glycolate NF 3.50 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Nitroglycerin Sublingual Tablets 0.3 mg (Net content of input item 1.95% Nitroglycerin on Lactose, USP is 54.16 kgs & Lactose Monohydrate NF 45.45 kgs & Sodium Starch Glycolate NF 12.32 kgs ))|| 1 Number|1|1.95% Nitroglycerin on Lactose, USP|15.692 mg.| |||||2|Lactose Monohydrate NF|12.912 mg.| |||||3|Sodium Starch Glycolate NF|3.50 mg.| ||Nitroglycerin Sublingual Tablets 0.4 mg (Net content of input item 1.95% Nitroglycerin on Lactose, USP is 573.55 kgs & Lactose Monohydrate NF 217.64 kgs & Sodium Starch Glycolate NF 97.86 kgs ))|| 1 Number|4|1.95% Nitroglycerin on Lactose, USP|20.923 mg.| |||||5|Lactose Monohydrate NF|7.784 mg.| |||||6|Sodium Starch Glycolate NF|3.50 mg.| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

odium Starch Glycolate NF|3.50 mg.| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Case No.	82 / NC/3/MEET/Nov/202526/10
Case Status	Case Approved
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00003202AM25
RA File Number	05AX04001955 AM25
Licence No and<br>Date	0511027881/20/09/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No. NC/3/MEET/Oct/202526/9 dated 14/10/2025 against advance<br>authorization No.0511031191 dated 04/03/2025, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Meropenem Sodium Sterile (Meropenem for<br>Injection)<br>(Containing NLT 84% Sterile Meropenem)<br>1 kg.<br>1<br>Meropenem Trihydrate<br>(Non Sterile)<br>0.8968 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	83 / NC/3/MEET/Nov/202526/10
Case Status	Case Approved
Party Name	HETERO LABS LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00003222AM25
RA File Number	09AX04000405 AM25
Licence No and Date	0911008005/23/09/2024

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

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.
1-([{(3R,3AS,6AR)-<br>HEXAHYDROFURO[2M3-B]<br>FURAN-3-YLOXY]<br>CARBONYL}OXY)PYRROLIDINE-<br>2,5-DIONE /<br>2,5 DIOXOPYRROLIDIN-1-YL((3R,<br>(1-([{(3R,3AS,6AR)-<br>HEXAHYDROFURO[2M3-B]<br>FURAN-3-YLOXY]<br>CARBONYL}OXY)PYRROLIDINE-<br>2,5-DIONE / 2,5<br>DIOXOPYRROLIDIN-1-<br>YL((3R,3AS,6AR)-<br>HYXAHYDROFURO [2M3-b]<br>FURAN-3-<br>YL) CARBONATE)	<br>1 kg.	1	(3AS, 4S, 6AR)-4-<br>METHOXYTETRAHYDROFURO[3,4-<br>B]FURAN-2(3H)-ONE(Naphthionic<br>acid (1-naphthylamine-4-<br>sulphonic acid), Para tolyl peri acid)	0.95 kg.
		2	SODIUM BORO HYDRIDE (HYDRIDES)	0.22 kg.
		3	TETRA HYDRO FURAN	5.04 kg.

Case No.	84 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	CADCHEM LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00003280AM25
RA File Number	30AX04000313 AM25
Licence No and<br>Date	3011005810/25/09/2024
Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

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

Case No.	85 / NC/3/MEET/Nov/202526/10
Case Status	Case Approved
Party Name	ATUL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00003293AM25
RA File Number	08AX04001033 AM25
Licence No and<br>Date	0811012739/26/09/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Neopentyl Glycol<br>0.460 kg.<br>2<br>Epichlorohydrin<br>0.940 kg.<br>Diglycidyl ether of Neopentyl Glycol<br>1 kg.<br>3<br>Caustic soda lye (Real)<br>0.385 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	86 / NC/3/MEET/Nov/202526/10
Case Status	Case Approved
Party Name	HOSTER LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00003335AM25
RA File Number	09AX04000509 AM25

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

03335AM25| |RA File Number|09AX04000509 AM25|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Licence No and Date

0911008057/27/09/2024

Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Ethyl-(2R,4S)-5-([1,1-biphenyl]-4- yl)-4-amino-2-methylpentanoate hydrochloride (Diloxanide furoate, Cimetidine, Oxyclozanide, Famotidine: Other) 1 kg. 1 (2R,4S)-5-([1,1-biphenyl]-4-yl)-4- ((tert-butoxycarbonyl)amino)-2- methylpentanoic acid (Other Nucleic Acids and their Salts) 1.21 kg. RA concerned may take further necessary action as per above decision of NC.

Case No.	87 / NC/3/MEET/Nov/202526/10
Case Status	Case Rejected
Party Name	PRIGIV SPECIALTIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00003427AM25
RA File Number	03AX04003148 AM25
Licence No and<br>Date	0311037588/03/10/2024
Norms Committee Decision:<br>The firm was initially granted an Advance Authorisation for the export product_“Rosacone”_<br>under Para 4.07 of the Handbook of Procedures (HBP).

0311037588/03/10/2024| |Norms Committee Decision: The firm was initially granted an Advance Authorisation for the export product_“Rosacone”_ 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.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

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

4.07 of HBP, to the Chairperson of the Norms Committee and to PC-4 Section, DGFT Headquarters.

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

Case No.	88 / NC/3/MEET/Nov/202526/10
Case Status	Case Rejected
Party Name	BVC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00003432AM25
RA File Number	34AX04000497 AM25
Licence No and<br>Date	3411005487/03/10/2024
Norms Committee Decision:<br>The firm was initially granted an Advance Authorisation for the export product_“Em Pentanoate_<br>_(Ethyl-2-Methyl Pentanoate”)_under Para 4.07 of the Handbook of Procedures (HBP). However,<br>as per Para 4.11(b) of the Foreign Trade Policy (FTP) 2023, products falling under the category<br>of perfume or perfumery compounds are ineligible for authorisation under Para 4.07 and are<br>mandatorily required to be processed under Para 4.06 of the HBP.<br>It was observed that the firm obtained the authorisation bymisdeclaring that its application<br>was covered under the provisions of Para 4.07, and has not furnished any technical<br>justification/information for the export product. Accordingly, the Committee found no merit in<br>fixing the norms and decided to reject the application.<br>The RA shall ensure that the said authorisation is regularised by recovery of applicable Customs<br>duty along with interest.

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

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Case No.	89 / NC/3/MEET/Nov/202526/10
Case Status	Case Rejected
Party Name	BVC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00003433AM25
RA File Number	34AX04000550 AM25
Licence No and<br>Date	3411005489/03/10/2024
Norms Committee Decision:<br>The firm was initially granted an Advance Authorisation for the export product_“Allyl_<br>_Heptanoate”_under Para 4.07 of the Handbook of Procedures (HBP).

9/03/10/2024| |Norms Committee Decision: The firm was initially granted an Advance Authorisation for the export product_“Allyl_ _Heptanoate”_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.||

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

Case No.<br>	90 / NC/3/MEET/Nov/202526/10
Case Status<br>	Case Deferred
Party Name<br>	ANANTA MEDICARE LIMITED
Meeting Number<br>and Date<br>	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number<br>	HQRNORM APPLY 00003450AM25
RA File Number<br>	05AX04001783 AM25
Licence No and<br>Date<br>	0511028112/03/10/2024
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: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Case No.	91 / NC/3/MEET/Nov/202526/10
Case Status	Case Approved
Party Name	BROOKS STERISCIENCE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00003492AM25
RA File Number	34AX04000554 AM25
Licence No and<br>Date	3411005493/04/10/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.

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 for Injection USP 500 mg. 1 Number 1 Meropenem with Sodium Carbonate USP (Sterile Meropenem Trihydrate with Sodium Carbonate) 672.60 mg. Meropenem for Injection USP 1000 mg. 1 Number 2 Meropenem with Sodium Carbonate USP(Sterile Meropenem Trihydrate with Sodium Carbonate) 1345.20 mg. Meropenem for Injection USP 2000 mg. 1 Number 3 Meropenem with Sodium Carbonate USP(Sterile Meropenem Trihydrate with sodium Carbonate) Not found in Drug Manufactguring Licence RA concerned may take further necessary action as per above decision of NC.||

Case No.	92 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

526/10| |---|---| |Case Status|Case Deferred|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Party Name	ENALTEC LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00003514AM25
RA File Number	03AX04003311 AM25
Licence No and<br>Date	0311037686/07/10/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Complete and balanced chemical reactions with Molecular weight and percentage yield on<br>molar basis.<br>1.<br>Name of the API produced from export it.<br>2.

Complete and balanced chemical reactions with Molecular weight and percentage yield on molar basis.

Case No.	93 / NC/3/MEET/Nov/202526/10
Case Status	Case Rejected
Party Name	ENCEE AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00003551AM25
RA File Number	32AX04000460 AM25
Licence No and<br>Date	3211007682/08/10/2024

|Meeting Number and Date|NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025| |HQ File Number|HQRNORM APPLY 00003551AM25| |RA File Number|32AX04000460 AM25| |Licence No and Date|3211007682/08/10/2024| |Norms Committee Decision: The firm was initially granted an Advance Authorisation for the export product _“Enamber/Kephalis/Tetrambrone”_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||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Section, DGFT Headquarters.

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

Case No.	94 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00003598AM25
RA File Number	09AX04000471 AM25
Licence No and<br>Date	0911008128/10/10/2024
Norms Committee Decision:<br>The Representative of the firm had attended the Personal Hearing and explained the case. The Committee heard the<br>explanation of Representative of the firm and after due deliberation the firm was advised to furnish the following<br>documents:<br>Tast report is July-August, 2023 which Advance Authorisation was issued in October, 2024.<br>1.<br>Copy of revised Certificate of Analysis of import & export items relevant to present Advance Authorisation.<br>2.<br>Revised Annexure to Appendix-4E.<br>3.

was issued in October, 2024. 1. Copy of revised Certificate of Analysis of import & export items relevant to present Advance Authorisation. 2. Revised Annexure to Appendix-4E. 3.||

Case No.	95 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00003600AM25
RA File Number	09AX04000467 AM25
Licence No and<br>Date	0911008130/10/10/2024
Norms Committee Decision:<br>The Representative of the firm had attended the Personal Hearing and explained the case. The Committee heard the<br>explanation of Representative of the firm and after due deliberation the firm was advised to furnish the following<br>documents:

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

I. Tast report is July-August, 2023 which Advance Authorisation was issued in October, 2024.
II. Copy of revised Certificate of Analysis of import & export items relevant to present Advance Authorisation.
III. Revised Annexure to Appendix-4E.

horisation was issued in October, 2024.

II. Copy of revised Certificate of Analysis of import & export items relevant to present Advance Authorisation.
III. Revised Annexure to Appendix-4E.

Case No.	96 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	ASTA BIOCHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00004300AM25
RA File Number	07AX04001295 AM25
Licence No and<br>Date	0711012868/22/11/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE, it was<br>decided to call for following information/documents from the firm:-<br>To give a balanced chemical reaction indicating molecular weight of both reactants and the products.<br>1.<br>Yield of the reaction with justification.<br>2.

Case No.	97 / NC/3/MEET/Nov/202526/10
Case Status	Case Approved
Party Name	MOREPEN LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00004305AM25
RA File Number	05AX04002794 AM25
Licence No and<br>Date	0511029135/22/11/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

ils given below or as applied by the firm, whichever is less:-||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Edoxaban<br>Tosylate<br>Monohydrate	<br>1 kg.	1	Tert-Butyl((1R,2S,5S)-2-Amino-5- (Dimethyl<br>Amino) Carbonyl) Cyclohexyl) Carbamate<br>(EDN02)	<br> <br>0.808 kg.
		2	Ethyl {(5-Chloropyridin-2-YL) Amino}-Oxoacetate<br>Hydrochloride (EDNS01)	<br>0.750 kg.
		3	4,5,6,7-Tetrahydro-5-Methylthiazolo{5,4-C}<br>Pyridine-2-Carboxylic Acid Hydrochloride<br>(EDNS03)	<br>0.500 kg.

ropyridin-2-YL) Amino}-Oxoacetate Hydrochloride (EDNS01)| 0.750 kg.| ||||3|4,5,6,7-Tetrahydro-5-Methylthiazolo{5,4-C} Pyridine-2-Carboxylic Acid Hydrochloride (EDNS03)| 0.500 kg.|

Case No.	98 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00004315AM25
RA File Number	34AX04000689 AM25
Licence No and<br>Date	3411005705/22/11/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	99 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	ADCOCK INGRAM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00004318AM25
RA File Number	07AX04001351 AM25

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

Licence No and<br>Date	0711012875/22/11/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it has been observed that export description does not<br>match with Drug Manufacturing Licence and working of norms applied. Hence it was decided to call the<br>firm for attendingPersonal Hearing<br> before Norms Committee to explain its case along with relevant<br>information / documents from the firm.

norms applied. Hence it was decided to call the firm for attendingPersonal Hearing before Norms Committee to explain its case along with relevant information / documents from the firm.||

Case No.	100 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	BENZO CHEM INDUSTRIES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00000087AM26
RA File Number	03AX04000001 AM26
Licence No and<br>Date	0311042847/04/04/2025
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, it was<br>decided to call for following information/documents from the firm:-<br>To give balanced chemical reaction indicating molecular weight of both reactants and the products.<br>1.<br>Yield of the reaction with justification.<br>2.<br>Function of using chemicals other than reactants in the process, clearly indicating whether, it is<br>solvent/neutralizer/catalyst etc. as the case may be<br>3.

Case No.	101 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	VIVA CORPORATION PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00001034AM26
RA File Number	03AX04000827 AM26
Licence No and<br>Date	0311044162/23/05/2025
Norms Committee Decision:

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

4162/23/05/2025| |Norms Committee Decision:||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00439229AM26

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

Complete chemistry with molecular weight, percentage yield and Stichometric balance

Case No.	102 / NC/3/MEET/Nov/202526/10
Case Status	Case Deferred
Party Name	BENZO CHEM INDUSTRIES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202526/ 10 and 14/11/2025
HQ File Number	HQRNORM APPLY 00001449AM26
RA File Number	03AX04001143 AM26
Licence No and<br>Date	0311044707/11/06/2025
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, it was<br>decided to call for following information/documents from the firm:-<br>To give balanced chemical reaction indicating molecular weight of both reactants and the products.<br>I.<br>Yield of the reaction with justification.<br>II.<br>Function of using chemicals other than reactants in the process, clearly indicating whether, it is<br>solvent/neutralizer/catalyst etc. as the case may be.<br>III.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 08-Dec-2025 15:40:00 Reason: ramankumar@nic.in Location: DGFT(HQ)

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