IN FORCE Advance Authorisation

DGFT Minutes

Reliability

In force — no superseding record on file.

Document text

UDIN00246597AM26

Government of India / भारत सरकार

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

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

VANIJYA BHAWAN, AKBAR ROAD, CENTRAL DELHI, DELHI, 110011 / वािणज्य भवन, अकबर रोड, नई िदल्ली Email Office : egtf-dgft@gov.in , Phone Office : 011-23062777

(DES - III SECTION)

Meeting No - NC/3/MEET/Jun/202526/5 Meeting Date - 30/06/2025

_ ________________________________________________________________________________

Minutes of the Norms Committee–3 Meeting No. NC/3/MEET/Jun/202526/5 dated 30/06/2025 (actually held on 04.07.2025) under the Chairmanship of Shri Rakesh Kumar, Addl. DGFT for considering the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2023 pertaining to Chemical and Allied Products falling under Chapter 29 and 30.

    Following members were present in the Meeting:-

Sl. No.	Name & Designation	Department
1	Shri D.N. Mathur, Technical Expert	Consultant (Pharma)
2	Shri Shaish Kumar, Technical Expert	Consultant (Chemical)
3	Shri Nand Lal, Technical Expert	Consultant (Chemical)
In attendance:
1	Shri Raman Kumar, Deputy DGFT	DGFT (HQ)
2	Shri Uttam Dey Sarkar, ASO	DGFT (HQ)

Signature Not Verified Signature Not Verified Digitally Signed. Digitally signa, Name: RAMAN KUMAR( Deputy Name: RAMAN KUJAAR( Deputy DGFT ) DGFT ) Date: 07-Aug-2025 11:54:47 Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ) Location:Reason: ramaniagnar@nic.inDGFTTHQ)

This document has been digitally signed by Raman Kumar, Deputy DGFT,DGFT(HQ) on 07-Aug-2025.

UDIN00246597AM26

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

This document has been digitally signed by Raman Kumar, Deputy DGFT,DGFT(HQ) on 07-Aug-2025.

UDIN00246597AM26

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

    RAs shall also ensure compliance of SION General Notes and Chapter Notes wherever applicable.

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

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004170AM25
RA File Number	NA
Licence No and<br>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 item in meeting No.NC/3/MEET/Mar/202324/25 dated 11/03/2024 against advance<br>authorization No.3111000876 dated 14/01/2022, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Mono Ethanol Amine<br>1.06 kg.<br>Ethylenediamine<br>1 kg<br>2<br>Ammonia Anhydrous<br>0.294 kg.<br>3<br>Mono Ethanol Amine<br>1.184 kg.<br>Di Ethylene Triamine<br>1 kg<br>4<br>Ammonia Anhydrous<br>0.165 kg.<br>Amino Ethyl Ethanol Amine<br>1 kg<br>5<br>Mono Ethanol Amine<br>1.173 kg.<br>Amino Ethyl Piperazine<br>1 kg<br>6<br>Mono Ethanol Amine<br>1.4186 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	2 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	BIOLOGICAL E. LIMITED

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

e Deferred| |Party Name|BIOLOGICAL E. LIMITED|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00005879AM25
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 and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>1. Label claim of Measles Vaccine Bulk in IU or other unit.<br>2. Process flow of manufacturing export product and stepwise wastage incurred in the manufacturing.<br>3. Certificate of Analysis (CoA) for the imported input products.

Case No.	3 / NC/3/MEET/Jun/202526/5
Case Status	Case Rejected
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM REVIW00005286AM25
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and the committee didn’t find any merit to review the<br>norms and it was decided torejectthe case maintaining thestatus quo.

Decision: The Committee considered the case as per agenda and the committee didn’t find any merit to review the norms and it was decided torejectthe case maintaining thestatus quo.||

Case No.	4 / NC/3/MEET/Jun/202526/5
Case Status	Case Rejected
Party Name	OPTRIX LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM REVIW00005287AM25
RA File Number	NA
Licence No and	NA

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Date

Norms Committee Decision:

The Committee considered the case as per agenda and the committee didn’t find any merit to review the norms and it was decided to reject the case maintaining the status quo.

Case No.	5 / NC/3/MEET/Jun/202526/5
Case Status	Case Rejected
Party Name	OPTRIX LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM REVIW00005288AM25
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and the committee didn’t find any merit to review the<br>norms and it was decided torejectthe case maintaining thestatus quo.

Decision: The Committee considered the case as per agenda and the committee didn’t find any merit to review the norms and it was decided torejectthe case maintaining thestatus quo.||

Case No.	6 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	STERLING AUXILIARIES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM REVIW00005039AM25
RA File Number	039504000135 AM20
Licence No and<br>Date	0310831916/30/09/2019
Norms Committee Decision:<br>The committee considered the request of firm for review of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>Justification of 20% wastage in chemical reaction for export item no. 2 and 3.<br>1.<br>Percentage solid content of export item no.2.<br>2.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

age solid content of export item no.2. 2.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Case No.	7 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	STERLING AUXILIARIES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM REVIW00005040AM25
RA File Number	039504000340 AM20
Licence No and<br>Date	0310831915/30/09/2019
Norms Committee Decision:<br>The committee considered the request of firm for review of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>Recovery of Methanol and its Commercial Value for in production of Export Product No. 1 -<br>STEROCARE CMEA (Coco Mono Ethanol Amide).

Case No.	Case No.	8 / NC/3/MEET/Jun/202526/5	8 / NC/3/MEET/Jun/202526/5	8 / NC/3/MEET/Jun/202526/5	8 / NC/3/MEET/Jun/202526/5	8 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		SRF LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM REVIW00005279AM25
RA File Number		052404000445 AM20
Licence No and<br>Date		0510412564/21/11/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol.

|Licence No and Date||0510412564/21/11/2019||||| |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 Sodium Methoxide 1.940 kg. 4,6-Dichloro-5-Fluoropyrimidine 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||4,6-Dichloro-5-Fluoropyrimidine||1 kg.|1|Sodium Methoxide|1.940 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

2	Formamide	1.078 kg.
3	Triethyl Amine	0.230 kg.
4	Methanol	1.25 kg.
5	2-Fluoro diethyl Melonate	2.133 kg.

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

-|---|---|---|---| ||||3|Triethyl Amine|0.230 kg.| ||||4|Methanol|1.25 kg.| ||||5|2-Fluoro diethyl Melonate|2.133 kg.|

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

Case No.	Case No.	9 / NC/3/MEET/Jun/202526/5	9 / NC/3/MEET/Jun/202526/5	9 / NC/3/MEET/Jun/202526/5	9 / NC/3/MEET/Jun/202526/5	9 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		ANUH PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00004744AM25
RA File Number		NA
Licence No and<br>Date		0310836875/25/06/2020
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/Jan/202425/15 dated 28.01.2025 against advance<br>authorization No.0511017696 dated 10/03/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Deflazacort IP/BP/EP<br>1 kg.<br>1<br>11 B, 16B)-HYDROXY 2-<br>METHLY-5H-PREGNA-1.4<br>DIENO (17.16D) OXAzole-3.0-<br>dione (D5)<br>1.00 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Deflazacort IP/BP/EP		1 kg.	1	11 B, 16B)-HYDROXY 2-<br>METHLY-5H-PREGNA-1.4<br>DIENO (17.16D) OXAzole-3.0-<br>dione (D5)	1.00 kg.

ty.**|Sl. No.|Import Items|Qty. allowed.| ||Deflazacort IP/BP/EP||1 kg.|1|11 B, 16B)-HYDROXY 2- METHLY-5H-PREGNA-1.4 DIENO (17.16D) OXAzole-3.0- dione (D5)|1.00 kg.| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Case No.	10 / NC/3/MEET/Jun/202526/5
Case Status	Case Rejected
Party Name	TOJO VIKAS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM REVIW00004894AM25
RA File Number	052404000149 AM21
Licence No and<br>Date	0510414531/01/07/2020
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the<br>firm has not provided any technical justification / information for enhancement. Hence, the committee<br>didn’t find any merit to review the norms and it was decided torejectthe case maintaining thestatus quo.

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

Case No.	Case No.	11 / NC/3/MEET/Jun/202526/5	11 / NC/3/MEET/Jun/202526/5	11 / NC/3/MEET/Jun/202526/5	11 / NC/3/MEET/Jun/202526/5	11 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		SRF LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM REVIW00005274AM25
RA File Number		052404000225 AM21
Licence No and<br>Date		0510414951/20/08/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Apr/202425/2 dated 30.04.2024 against advance<br>authorization No.0511013749 dated 13/07/2022, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty.<br>allowed.
	Export Product		Qty.	Sl.<br>No.	Import Items	Qty.<br>allowed.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

.**|Import Items|Qty. allowed.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

1	Dimethyl Formamide (DMF)	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	Hydrazine Hydrate (100%)	0.668 kg.

Case No.	12 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	STERLING AUXILIARIES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM REVIW00005036AM25
RA File Number	039504000492 AM21
Licence No and<br>Date	0310839386/06/11/2020

D| |Meeting Number and Date|NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025| |HQ File Number|HQRNORM REVIW00005036AM25| |RA File Number|039504000492 AM21| |Licence No and Date|0310839386/06/11/2020| |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 manufacturing process with chemical reaction molecular weight and percentage yield and Stoichiometric Balance. 1. Details of indigenous inputs. 2.||

Case No. 13 / NC/3/MEET/Jun/202526/5

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Case Status	Case Rejected
Party Name	ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM REVIW00005110AM25
RA File Number	03AA04025749 AM22
Licence No and<br>Date	0311005018/29/06/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the<br>firm has not provided any technical justification / information for enhancement. Hence, the committee<br>didn’t find any merit to review the norms and it was decided torejectthe case maintaining thestatus quo.

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

Case No.	14 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	ACUTAAS CHEMICALS LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM REVIW00005112AM25
RA File Number	52AA04010429 AM22
Licence No and Date	5211001058/27/07/2021
Norms Committee Decision:<br>The committee considered the request of firm for review of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>Justification for low yield reaction (56.8% & 87%) shown in first and second steps.<br>1.

Case No.	15 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM REVIW00005277AM25
RA File Number	05AA04071036 AM22
Licence No and<br>Date	0511004601/08/09/2021
Norms Committee Decision:

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

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:-

AM26

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.<br>No.	Import Items	Qty. allowed.
Methoxy Trifluoro Methyl<br>Pyridine	1 kg.	1	Trimethyl Phosphonoacetate	1.973 kg.
		2	Toluene (Bulk)	Not imported
		3	Formamide	0.662 kg.
		4	Dimethyl Formamide<br>(DMF, Drum)	0.533 kg.
		5	N-Hexane - 95 Percent	Not imported
		6	Tri Ethyl Amine (TEA)	Not imported
		7	Potassium Carbonate Powder	Not imported
		8	Ethyl Vinyl Ether	1.133 kg.
		9	Trichloroacetyl<br>Chloride<br>[TCAC]	Not imported
		10	Methanol	Not imported

Case No.	16 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

2526/5| |---|---| |Case Status|Case Approved|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Party Name	Party Name	SRF LIMITED	SRF LIMITED	SRF LIMITED	SRF LIMITED	SRF LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM REVIW00005265AM25
RA File Number		05AA04061713 AM22
Licence No and<br>Date		0511004657/10/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 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>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>5<br>Toluene<br>0.315 kg.<br>6<br>Mixed Hexanes<br>0.236 kg.<br>7<br>N-Butanol<br>0.010 kg.<br>3-Difluoromethyl-1-<br>Methyl-1H-Pyrazole-4-<br>Carboxylic Acid<br>1 kg.<br>8<br>Hydrazine Hydrate<br>(100 Percent)<br>0.668 kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

ydrazine Hydrate (100 Percent) 0.668 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||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 Percent)|0.668 kg.| |||||action as per above decision of NC.|||

Case No.	17 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM REVIW00005257AM25
RA File Number	05AX04000086 AM22
Licence No and<br>Date	0511007243/27/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 HYPE 0.910 kg. 2 TFMT Na IN Acetone 1.91 kg. TESA-1-(3-Chloropyridin-2YL)-3- [5- (Trifluoromethyl) - 2H Tetrazol- 2YLmethyl-1H-Pyrazole-5- Carboxylic Acid 1 kg. 3 Toluene 0.55 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	18 / NC/3/MEET/Jun/202526/5
Case Status	Case Rejected
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM REVIW00004762AM25
RA File Number	07AX04000122 AM23
Licence No and<br>Date	0711004059/23/05/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, the committee didn’t<br>find any merit to review the norms and it was decided torejectthe case maintaining thestatus quo.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

ctthe case maintaining thestatus quo.**||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Case No.	19 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	RUMIT LIFE CARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM REVIW00004885AM25
RA File Number	03AX04001057 AM23
Licence No and<br>Date	0311015409/10/06/2022
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Stepwise chemical reactions, Molecular weight and percentage yield on molar basis.<br>1.<br>Production/Consumption data duly certified by Chartered Accountant for the past three years.<br>2.

Case No.	20 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	STERLING AUXILIARIES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
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 review of ad-hoc norms and it was observed that the firm<br>has uploaded the documents for review on portal is pertains to Norms Committee-1. Therefore, the<br>committee has decided to advise the firm to submit the proper documents for review.

he firm has uploaded the documents for review on portal is pertains to Norms Committee-1. Therefore, the committee has decided to advise the firm to submit the proper documents for review.||

Case No.	21 / NC/3/MEET/Jun/202526/5
Case Status	Case Rejected

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM REVIW00004727AM25
RA File Number	07AX04000935 AM23
Licence No and<br>Date	0711005338/27/09/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, the committee didn’t<br>find any merit to review the norms and it was decided torejectthe case maintaining thestatus quo.

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

Case No.	22 / NC/3/MEET/Jun/202526/5
Case Status	Case Rejected
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM REVIW00004743AM25
RA File Number	07AX04001102 AM23
Licence No and<br>Date	0711005565/28/10/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, the committee didn’t<br>find any merit to review the norms and it was decided torejectthe case maintaining thestatus quo.

Case No.	23 / NC/3/MEET/Jun/202526/5
Case Status	Case Rejected
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM REVIW00005271AM25
RA File Number	05AX04002651 AM23
Licence No and<br>Date	0511016260/08/12/2022
Norms Committee Decision:

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

6260/08/12/2022| |Norms Committee Decision:||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

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

Case No.	24 / NC/3/MEET/Jun/202526/5
Case Status	Case Rejected
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM REVIW00004788AM25
RA File Number	07AX04001545 AM23
Licence No and<br>Date	0711006198/16/01/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, the committee didn’t<br>find any merit to review the norms and it was decided torejectthe case maintaining thestatus quo.

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

Case No.	25 / NC/3/MEET/Jun/202526/5
Case Status	Case Rejected
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM REVIW00004789AM25
RA File Number	07AX04000372 AM24
Licence No and<br>Date	0711008298/19/06/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, the committee didn’t<br>find any merit to review the norms and it was decided torejectthe case maintaining thestatus quo.

Case No. 26 / NC/3/MEET/Jun/202526/5

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

o.**||

Case No. 26 / NC/3/MEET/Jun/202526/5

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Case Status	Case Rejected
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM REVIW00004729AM25
RA File Number	07AX04000426 AM24
Licence No and<br>Date	0711008352/22/06/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, the committee didn’t<br>find any merit to review the norms and it was decided torejectthe case maintaining thestatus quo.

Case No.	Case No.	27 / NC/3/MEET/Jun/202526/5	27 / NC/3/MEET/Jun/202526/5	27 / NC/3/MEET/Jun/202526/5	27 / NC/3/MEET/Jun/202526/5	27 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		MANKIND PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM REVIW00005113AM25
RA File Number		05AX04001023 AM24
Licence No and<br>Date		0511019756/12/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl. No.

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. Timolol Maleate Ophthalmic Solution, USP 0.5% (5 mL) 339623 Numbers 1 Timolol Maleate USP 11778.14 gm Timolol Maleate Ophthalmic Solution, USP 0.5% (10 mL) 169811 Numbers 2 Timolol Maleate USP 11778.10 gm Timolol Maleate Ophthalmic Solution, USP 0.25% (5 mL) 51000 Numbers 3 Timolol Maleate USP 0.884 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Timolol Maleate Ophthalmic Solution, USP 0.5% (5 mL)||339623 Numbers|1|Timolol Maleate USP|11778.14 gm| ||Timolol Maleate Ophthalmic Solution, USP 0.5% (10 mL)||169811 Numbers|2|Timolol Maleate USP|11778.10 gm| ||Timolol Maleate Ophthalmic Solution, USP 0.25% (5 mL)||51000 Numbers|3|Timolol Maleate USP|0.884 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Timolol Maleate Ophthalmic	20000	4	Timolol Maleate USP	0.694 kg.
Solution, USP 0.25% (10 mL)	Numbers

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

UDIN00246597AM26

Timolol Maleate Ophthalmic	20000	4	Timolol Maleate USP	0.694 kg.
Solution, USP 0.25% (10 mL)	Numbers

Case No.	28 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	HIKAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004972AM24
RA File Number	03AX04002023 AM24
Licence No and<br>Date	0311026196/10/08/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Stepwise chemical reactions with structural formula and chemical name of each input and output<br>product, with molecular weight.<br>1.<br>Percentage yield on molar basis.<br>2.

Case No.	29 / NC/3/MEET/Jun/202526/5
Case Status	Case Rejected
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM REVIW00004786AM25
RA File Number	07AX04001166 AM24
Licence No and<br>Date	0711009545/26/10/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

f ad-hoc norms and it was observed that the||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

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

Case No.	Case No.	30 / NC/3/MEET/Jun/202526/5	30 / NC/3/MEET/Jun/202526/5	30 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		METROCHEM API PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00006520AM24
RA File Number		09AX04000671 AM24
Licence No and<br>Date		0911006113/30/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Methanol<br>3.45 kg.<br>2<br>Methylene Di Chloride<br>7.42 kg.<br>3<br>Tetra Hydro Furan (THF)<br>0.88 kg.<br>4<br>Lithium metal<br>0.100 kg.<br>5<br>Acetonitrile<br>2.00 kg.<br>6<br>N-Heptane<br>1.50 kg.<br>7<br>(S)-3-Hydroxy Tetrahydro Furan<br>0.97 kg.<br>Empagliflozin<br>1 kg.<br>8<br>Triethyl Silane<br>2.70 kg.
	Export Product		Qty.	**Sl.

2.00 kg. 6 N-Heptane 1.50 kg. 7 (S)-3-Hydroxy Tetrahydro Furan 0.97 kg. Empagliflozin 1 kg. 8 Triethyl Silane 2.70 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Empagliflozin||1 kg.|1|Methanol|3.45 kg.| |||||2|Methylene Di Chloride|7.42 kg.| |||||3|Tetra Hydro Furan (THF)|0.88 kg.| |||||4|Lithium metal|0.100 kg.| |||||5|Acetonitrile|2.00 kg.| |||||6|N-Heptane|1.50 kg.| |||||7|(S)-3-Hydroxy Tetrahydro Furan|0.97 kg.| |||||8|Triethyl Silane|2.70 kg.|

Case No.	Case No.	30 / NC/3/MEET/Jun/202526/5	30 / NC/3/MEET/Jun/202526/5	30 / NC/3/MEET/Jun/202526/5	30 / NC/3/MEET/Jun/202526/5	30 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		METROCHEM API PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00006520AM24
RA File Number		09AX04000671 AM24
Licence No and<br>Date		0911006113/30/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Methanol 3.45 kg. 2 Methylene Di Chloride 7.42 kg. 3 Tetra Hydro Furan (THF) 0.88 kg. 4 Lithium metal 0.100 kg. 5 Acetonitrile 2.00 kg. 6 N-Heptane 1.50 kg. 7 (S)-3-Hydroxy Tetrahydro Furan 0.97 kg. Empagliflozin 1 kg. 8 Triethyl Silane 2.70 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Empagliflozin||1 kg.|1|Methanol|3.45 kg.| |||||2|Methylene Di Chloride|7.42 kg.| |||||3|Tetra Hydro Furan (THF)|0.88 kg.| |||||4|Lithium metal|0.100 kg.| |||||5|Acetonitrile|2.00 kg.| |||||6|N-Heptane|1.50 kg.| |||||7|(S)-3-Hydroxy Tetrahydro Furan|0.97 kg.| |||||8|Triethyl Silane|2.70 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

n|0.97 kg.| |||||8|Triethyl Silane|2.70 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Case No.	31 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM REVIW00004787AM25
RA File Number	07AX04001679 AM24
Licence No and<br>Date	0711010304/23/01/2024
Norms Committee Decision:<br>The committee considered the request of firm for review of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>Copy of Drug Manufacturing License (DML) showing approved composition of each export item.

Case No.	32 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	METROCHEM API PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00008252AM24
RA File Number	09AX04000962 AM24
Licence No and<br>Date	0911006666/31/01/2024
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/Mar/202425/18 dated 17/03/2025 against advance<br>authorization No.0911006227 dated 14/11/2023, 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:-

ce authorization No.0911006227 dated 14/11/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Vonoprazan Fumarate	1 kg.	1	2-Fluoro Acetophenone	0.860 kg.
		2	Pyridine 3 sulfonyl chloride	0.856 kg.
		3	Tetrahydrofuran	3.29 kg.
		4	Methylene Di Chloride	3.80 kg.
		5	Sodium Borohydrate	0.22 kg.
		6	Potassium Carbonate	0.66 kg.
		7	Di Methyl sulfoxide	1.00 kg.

hloride|0.856 kg.| ||||3|Tetrahydrofuran|3.29 kg.| ||||4|Methylene Di Chloride|3.80 kg.| ||||5|Sodium Borohydrate|0.22 kg.| ||||6|Potassium Carbonate|0.66 kg.| ||||7|Di Methyl sulfoxide|1.00 kg.|

Case No.	33 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00003967AM25
RA File Number	05AX04002513 AM25
Licence No and<br>Date	0511028684/01/11/2024
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/Dec/202425/13 dated 07/01/2025 against advance<br>authorization No.0511026754 dated 19/07/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

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

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Nitroglycerin<br>Sublingual<br>Tablets USP, 0.3mg	<br>1 Number	1	Diluted Nitroglycerin USP<br>(2% w/w)	15.30 mg.
Nitroglycerin<br>Sublingual<br>Tablets USP, 0.4mg	<br>1 Number	2	Diluted Nitroglycerin USP<br>(2% w/w)	20.40 mg.
Nitroglycerin<br>Sublingual<br>Tablets USP, 0.6mg	<br>1 Number	3	Diluted Nitroglycerin USP<br>(2% w/w)	30.60 mg.

lets USP, 0.4mg| 1 Number|2|Diluted Nitroglycerin USP (2% w/w)|20.40 mg.| ||Nitroglycerin Sublingual Tablets USP, 0.6mg| 1 Number|3|Diluted Nitroglycerin USP (2% w/w)|30.60 mg.|

Case No.	Case No.	34 / NC/3/MEET/Jun/202526/5	34 / NC/3/MEET/Jun/202526/5	34 / NC/3/MEET/Jun/202526/5	34 / NC/3/MEET/Jun/202526/5	34 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		KLJ PETROPLAST LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00003968AM25
RA File Number		05AX04002476 AM25
Licence No and<br>Date		0511028685/01/11/2024
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/Mar/202425/19 dated 27/03/2025 against DGFT Hqr.<br>File No.HQRNORMREVIW00006341AM25, 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.<br>Import Items<br>Qty. allowed.<br>1<br>Phthalic Anhydride<br>0.700 kg.<br>Di-Ethyl Phthalate (DEP) (Packed<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Di-Ethyl Phthalate (DEP) (Packed		1 kg.	1	Phthalic Anhydride	0.700 kg.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Packed||1 kg.|1|Phthalic Anhydride|0.700 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

RA	In 2000 Nos. of HM-HDPE Drums<br>made of HDPE Granules<br>(17,000.000 Kgs. without wastage))<br>(each Drum shall weight 8.5 Kg and<br>Storage Capacity 250.000 Kgs.))		2	Denatured Ethyl Alcohol	0.435 kg.
			3	HDPE Granules (Total<br>weight =17,850.000 kg.)	As per Packing<br>Policy<br>and<br>Genral Notes.
	concerned may take further necessary action as per above decision of NC.

Case No.	35 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	RUBICON RESEARCH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00003973AM25
RA File Number	03AX04003873 AM25
Licence No and<br>Date	0311038428/04/11/2024
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advice of<br>the TE, it was decided to call for following information/documents from the firm:-<br>Copy of Drug Manufacturing Licence (DML).<br>1.<br>Copy of Master-Batch Formula for each export product.<br>2.

Case No.	36 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00003974AM25
RA File Number	05AX04002518 AM25
Licence No and	0511028694/04/11/2024

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Date

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Jun/202324/8 dated 30/06/2023 against advance authorization No.0511018335 dated 17/04/2023, 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.
Cefuroxime Sodium Sterile	1 Kg.	1	Cefuroxime Acid	1.04 Kg.

Case No.<br>37 / NC/3/MEET/Jun/202526/5
Case Status<br>Case Approved
Party Name<br>AARTI DRUGS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number<br>HQRNORM APPLY 00003983AM25
RA File Number<br>03AX04003864 AM25
Licence No and<br>Date<br>0311038449/04/11/2024
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision		for same export
product/import item in meeting No.NC/3/MEET/Dec/202425/3 dated 07/01/2025 against advance
authorization No.0311035695 dated 22/07/2024, it	was decided to fix ad-hoc norms under Para 4.07 of
HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty. allowed.
1<br>Ciprofloxacin Hydrochloride<br>1 kg.	Ethyl 3 Cyclopropylamino-2(2,4	1.240 kg.
IP/BP/EP/USP	Dichloro-5Fluorobenzoyl) Acrylate

Qty.** Sl. No.|Import Items|Qty. allowed.|| |1 Ciprofloxacin Hydrochloride 1 kg.|Ethyl 3 Cyclopropylamino-2(2,4|1.240 kg.|| |IP/BP/EP/USP|Dichloro-5Fluorobenzoyl) Acrylate|||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

2 Piperazine (68%) 0.574 kg.

Case No.	38 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	KLJ PETROPLAST LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00003984AM25
RA File Number	05AX04002475 AM25
Licence No and<br>Date	0511028726/05/11/2024
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/Mar/202425/19 dated 27/03/2025 against DGFT Hqr.<br>File No.HQRNORMREVIW00006341AM25, 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.<br>Import Items<br>Qty. allowed.<br>1<br>Phthalic Anhydride<br>0.700 kg.<br>Di-Ethyl Phthalate (DEP)<br>1 kg.<br>2<br>Denatured Ethyl Alcohol<br>0.435 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	39 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved

natured Ethyl Alcohol 0.435 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	39 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Party Name	RASULA PHARMACEUTICALS AND FINE CHEMICALS
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00003993AM25
RA File Number	09AX04000607 AM25
Licence No and<br>Date	0911008315/06/11/2024
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:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty. allowed.<br>Methyl Paraben BP/USP/NF/ Para<br>Hydroxy Benzoate BP/ Methyl Para<br>Hydroxy Benzoate Ph.Eur<br>1 kg.<br>1<br>Para Hydroxy Benzoic<br>Acid PHBA<br>0.95 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Benzoate BP/ Methyl Para Hydroxy Benzoate Ph.Eur 1 kg. 1 Para Hydroxy Benzoic Acid PHBA 0.95 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	40 / NC/3/MEET/Jun/202526/5	40 / NC/3/MEET/Jun/202526/5	40 / NC/3/MEET/Jun/202526/5	40 / NC/3/MEET/Jun/202526/5	40 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		MICRO LABS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00003999AM25
RA File Number		07AX04001233 AM25
Licence No and<br>Date		0711012713/06/11/2024
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:-<br>Sl.<br>Export Product<br>Qty.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl.	Import Items	Qty. allowed.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

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

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

No.<br>Olopatadine Hydrochloride Opthalmic<br>Solution 0.1%W/V 5ml (Each Ml Contains<br>1.11 mg of Olopatadine Hydrochloride) (Net<br>Contents :1884.86 Gms))<br>1 Number<br>1<br>Olopatadine<br>Hydrochloride<br>BP/EP/IP/USP<br>5.661 mg.<br>Olopatadine Hydrochloride Opthalmic<br>Solution 0.2 %W/V 2.5ml (Each Ml<br>Contains 2.22 mg of Olopatadine<br>Hydrochloride<br>(Net Contents : 1438.89 Gms)<br>1 Number<br>2<br>Olopatadine<br>Hydrochloride<br>BP/EP/IP/USP<br>5.661 mg.<br>RA concerned may take further necessary action as per above decision of NC.			No.
	Olopatadine Hydrochloride Opthalmic<br>Solution 0.1%W/V 5ml (Each Ml Contains<br>1.11 mg of Olopatadine Hydrochloride) (Net<br>Contents :1884.86 Gms))	1 Number	1	Olopatadine<br>Hydrochloride<br>BP/EP/IP/USP	5.661 mg.
	Olopatadine Hydrochloride Opthalmic<br>Solution 0.2 %W/V 2.5ml (Each Ml<br>Contains 2.22 mg of Olopatadine<br>Hydrochloride<br>(Net Contents : 1438.89 Gms)	1 Number	2	Olopatadine<br>Hydrochloride<br>BP/EP/IP/USP	5.661 mg.

Case No.	Case No.	41 / NC/3/MEET/Jun/202526/5	41 / NC/3/MEET/Jun/202526/5	41 / NC/3/MEET/Jun/202526/5	41 / NC/3/MEET/Jun/202526/5	41 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		USV PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00004004AM25
RA File Number		03AX04003907 AM25
Licence No and<br>Date		0311038503/06/11/2024
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:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty. allowed.<br>Desipramine Hydrochloride Tablets,<br>USP 10 Mg 100 S((8,000 Bottles X<br>100 Per Bottles = 8,00,000 Tablets)<br>1 Number<br>1<br>Desipramine HCL<br>USP<br>10.2 mg/Tablet
	Export Product		Qty.	Sl.<br>No.	Import Items	Qty. allowed.
	Desipramine Hydrochloride Tablets,<br>USP 10 Mg 100 S((8,000 Bottles X<br>100 Per Bottles = 8,00,000 Tablets)		1 Number	1	Desipramine HCL<br>USP	10.2 mg/Tablet

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

mber|1|Desipramine HCL USP|10.2 mg/Tablet|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

(Total Weight of Export Product =
8.000 Kgs) (Net Content weight of
Import Product = 8.471 kgs))
Desipramine Hydrochloride Tablets,	1 Number	2	Desipramine HCL	25.50 mg/Tablet
USP 25 Mg 100 S((6,000 Bottles X			USP
100 Per Bottles = 6,00,000 Tablets)
(Total Weight of Export Product =
15.000 Kgs) (Net Content weight of
Import Product = 15.884 kgs))

Case No.<br>42 / NC/3/MEET/Jun/202526/5	Case No.<br>42 / NC/3/MEET/Jun/202526/5
Case Status<br>Case Approved
Party Name<br>FDC LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number<br>HQRNORM APPLY 00004012AM25
RA File Number<br>03AX04003860 AM25
Licence No and<br>Date<br>0311038515/06/11/2024
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.	Import Items	Qty. allowed.
		No.
Gentamicin Eye/Ear Drops 5 Ml	1 Number	1	Gentamicin	18.377 mg/5ml.
(Bactigen Eye/Ear Drops 5 Ml) ((Each			Sulphate(API)
Vial Contains Gentamicin Sulphate
0.015 Gm Net Wt of Bulk Drug is
6.951 Kgs))

|1 Number|1|Gentamicin|18.377 mg/5ml.|| |(Bactigen Eye/Ear Drops 5 Ml) ((Each|||Sulphate(API)||| |Vial Contains Gentamicin Sulphate|||||| |0.015 Gm Net Wt of Bulk Drug is|||||| |6.951 Kgs))||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Gentamicin Eye/Ear Drops 10 Ml<br>(Bactigen Eye/Ear Drops 10 Ml)<br>((Each Vial Contains Gentamicin<br>Sulphate 0.030 Gm Net Wt of Bulk<br>Drug is 3.420 Kgs))<br>1 Number<br>2<br>Gentamicin<br>Sulphate(API)<br>36.754 mg/10 ml.<br>RA concerned may take further necessary action as per above decision of NC.	Gentamicin Eye/Ear Drops 10 Ml<br>(Bactigen Eye/Ear Drops 10 Ml)<br>((Each Vial Contains Gentamicin<br>Sulphate 0.030 Gm Net Wt of Bulk<br>Drug is 3.420 Kgs))	1 Number	2	Gentamicin<br>Sulphate(API)	36.754 mg/10 ml.

Case No.	43 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	UNIMAX LABORATORIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004021AM25
RA File Number	05AX04002556 AM25
Licence No and<br>Date	0511028766/07/11/2024
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:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>**Qty.

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. Spiramycin Tablets 1.5 MIU (Each tablet contains Spiramycin EP) 1 Number 1 Spiramycin EP 373.02 mg/Tablet Spiramycin Tablets 3.0 MIU (Each tablet contains Spiramycin EP) 1 Number 2 Spiramycin EP 746.04 mg/Tablet RA concerned may take further necessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Case No.	44 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004024AM25
RA File Number	34AX04000672 AM25
Licence No and<br>Date	3411005648/07/11/2024
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/202425/8 dated 28/08/2024 against advance<br>authorization No.0811011317 dated 18/04/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

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. Minoxidil Topical Aerosol 5% ( Foam) 60 Gm CAN) 1 Number 1 Minoxidil USP 3.06 gm. **Note:**The Committee also decided to fix a SION for above export product. RA concerned may take further necessary action as per above decision of NC.||

Case No.	45 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	CADCHEM LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004027AM25
RA File Number	30AX04000395 AM25
Licence No and	3011006010/07/11/2024

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Date

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/Apr/202324/1 dated 28/04/2023 against advance authorization No. 0311019771 dated 06/12/2022, 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.
Benfotiamine	1 kg	1	Thiamine Hydrochloride<br>(Vitamin B1 HCL)	0.922 kg.

Note: The Committee also decided to fix a SION for above export product.

Case No.	Case No.	46 / NC/3/MEET/Jun/202526/5	46 / NC/3/MEET/Jun/202526/5	46 / NC/3/MEET/Jun/202526/5	46 / NC/3/MEET/Jun/202526/5	46 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00004029AM25
RA File Number		34AX04000675 AM25
Licence No and<br>Date		3411005651/07/11/2024
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:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl.<br>No.	Import Items	Qty. allowed.

ess:- 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: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Fulvestrant Injection	250	mg /	5	ML	1	Number	1	Fulvestrant USP	262.3	mg/Vial
(50mg/ML)

		Fulvestrant Injection 250 mg / 5 ML<br>50/ML	Fulvestrant Injection 250 mg / 5 ML<br>50/ML
		(mg)


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





Case No.			47 / NC/3/MEET/Jun/202526/5
C	ase Status		Case Approved
P	arty Name		VENUS REMEDIES LIMITED
M<br>a	eeting Number<br>nd Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
H	Q File Number		HQRNORM APPLY 00004046AM25
R	A File Number		30AX04000419 AM25
L<br>D	icence No and<br>ate		3011006022/08/11/2024
N<br> <br> <br> <br>

|Q File Number||HQRNORM APPLY 00004046AM25||||||||||| |R|A File Number||30AX04000419 AM25||||||||||| |L D|icence No and ate||3011006022/08/11/2024||||||||||| |N |||||||||||||| ||orms Committee Decision: The Committee considered the case as per a product/import item in meeting No.NC/ |||||genda and ta 3/MEET/Mar ||king cue /202425 |from the earlier decisi /19 dated 27/03/202 |||on for same export 5 against advance || ||authorization No. 3011005556 dated 02/0 HBP Vol. I as per details given below or as|||||/2024, it wa applied by th||s decide e firm,|d to fix ad-hoc norms whichever is less:-|||under Para 4.07 of|| ||||||||||||||| ||Export Product|||Qty.|||Sl. No.||Import Items||||Qty. | ||Ceftazidime Powder for Solution for Injection or Infusion 1.0 g (Each Vial||||||||||||allowed| ||||| 1 Number|||1||Ceftazidime Pentahydrate with Sodium Carbonate|||| 1.258 gm.| ||Contains:||Ceftazidime (as||||||Sterile||||| ||pentahydrate)||1g with sodium||||||||||| ||carbonate (11||8 mg per gram of||||||||||| ||ceftazidime C Ceftazidime Pe||ontaining 50.005 Kg of ntahydrate with Sodium| |||||||||| ||Carbonate Ster||ile)||||||||||| ||||||||||||||| ||||||||||||||| ||Ceftazidime P Ii I||owder for Solution for fi 20 Eh Vil| 1 Number|||2||Ceftazidime Pentahydrate ih Sdi Cb|||| 2.516 gm.| ||njecton or nuson .

||| ||||||||||||||| ||Ceftazidime P Ii I||owder for Solution for fi 20 Eh Vil| 1 Number|||2||Ceftazidime Pentahydrate ih Sdi Cb|||| 2.516 gm.| ||njecton or nuson . g (ac a Contains: Ceftazidime (as pentahydrate) 2g with sodium||| |||||wt oum aronate Sterile|||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

carbonate (118 mg per gram of ceftazidime Containing 50.003 Kg of Ceftazidime Pentahydrate with Sodium Carbonate Sterile)

Case No.	48 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	MANGALAM ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004063AM25
RA File Number	03AX04002657 AM25
Licence No and<br>Date	0311038605/11/11/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Percentage yield of reaction with molecular weight of export and import items.

s and as per the advice of the TE, it was decided to call for following information/documents from the firm:- Percentage yield of reaction with molecular weight of export and import items.||

Case No.	49 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	ARESKO LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004065AM25
RA File Number	05AX04002537 AM25
Licence No and<br>Date	0511028833/11/11/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

TE, it was decided to call for following information/documents from the firm:-

Complete and Balanced chemical reaction with molecular weight and percentage yield on molar basis for each export item separately.
Past Production/Consumption certificate for last three years for each export item.

chemical reaction with molecular weight and percentage yield on molar basis for each export item separately.

Past Production/Consumption certificate for last three years for each export item.

Case No.	50 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	ZEOLITES AND ALLIED PRODUCTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004069AM25
RA File Number	03AX04003739 AM25
Licence No and<br>Date	0311038608/11/11/2024
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/Mar/202324/26 dated 22/03/2024 against advance<br>authorization No. 0311029806 dated 01/01/2024, 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>Cyclopentanone<br>1 kg.<br>1<br>Adipic Acid<br>1.93 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	51 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	SYNERGIA SCIENCES PRIVATE LIMITED

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Party Name|SYNERGIA SCIENCES PRIVATE LIMITED|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004086AM25
RA File Number	03AX04003672 AM25
Licence No and<br>Date	0311038648/12/11/2024
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per theadvice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>As per details submitted item is manufactured from either import item No.1 or import item no. 2 & 3.<br>1.<br>As such quantity of export made from import item No.1 and quantity of export made from import<br>item no.2 & 3.<br>2.

Case No.	Case No.	52 / NC/3/MEET/Jun/202526/5	52 / NC/3/MEET/Jun/202526/5	52 / NC/3/MEET/Jun/202526/5	52 / NC/3/MEET/Jun/202526/5	52 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00004088AM25
RA File Number		03AX04003955 AM25
Licence No and<br>Date		0311038649/12/11/2024
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.

|Licence No and Date||0311038649/12/11/2024||||| |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. 1 Fenoterol Hydrobromide 510.00 gm. Ipratropium Bromide/ Fenoterol Hydrobromide Pressurised Inhalation Solution 20ug/50ug per actuation ( 1 x 200 MDI ) ((Net Wt. of Fenoterol Hydrobromide is Qty. 500.00 Grams and Ipratropium Bromide is Qty. 50000 Numbers 2 Ipratropium Bromide 204.00 gm.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Ipratropium Bromide/ Fenoterol Hydrobromide Pressurised Inhalation Solution 20ug/50ug per actuation ( 1 x 200 MDI ) ((Net Wt. of Fenoterol Hydrobromide is Qty. 500.00 Grams and Ipratropium Bromide is Qty.||50000 Numbers|1|Fenoterol Hydrobromide|510.00 gm.| |||||2|Ipratropium Bromide|204.00 gm.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

0 gm.| |||||2|Ipratropium Bromide|204.00 gm.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

200.00 Grams))<br>3<br>Fenoterol Hydrobromide<br>765.00 gm.<br>Ipratropium Bromide/ Fenoterol<br>Hydrobromide Pressurised<br>Inhalation Solution 20ug/50ug per<br>actuation ( 3 x 200 MDI ) (Net<br>Wt. of Fenoterol Hydrobromide is<br>Qty. 750.00 Grams and<br>Ipratropium Bromide is Qty.<br>300.00 Grams))<br>25000<br>Numbers<br>4<br>Ipratropium Bromide<br>306.00 gm.<br>RA concerned may take further necessary action as per above decision of NC.	200.00 Grams))
	Ipratropium Bromide/ Fenoterol<br>Hydrobromide Pressurised<br>Inhalation Solution 20ug/50ug per<br>actuation ( 3 x 200 MDI ) (Net<br>Wt. of Fenoterol Hydrobromide is<br>Qty. 750.00 Grams and<br>Ipratropium Bromide is Qty.<br>300.00 Grams))	25000<br>Numbers	3	Fenoterol Hydrobromide	765.00 gm.
			4	Ipratropium Bromide	306.00 gm.

of Fenoterol Hydrobromide is Qty. 750.00 Grams and Ipratropium Bromide is Qty. 300.00 Grams))|25000 Numbers|3|Fenoterol Hydrobromide|765.00 gm.| ||||4|Ipratropium Bromide|306.00 gm.|

Case No.	Case No.	53 / NC/3/MEET/Jun/202526/5	53 / NC/3/MEET/Jun/202526/5	53 / NC/3/MEET/Jun/202526/5	53 / NC/3/MEET/Jun/202526/5	53 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		KALPSUTRA CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00004116AM25
RA File Number		03AX04003746 AM25
Licence No and<br>Date		0311038672/13/11/2024
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/Dec/202425/12 dated 10/12/2024 against advance<br>authorization No. 0311035090 dated 01/07/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed<br>Isobornyl Cyclohexanol<br>1 kg.<br>1<br>Gum Turpentine Oil<br>1.582 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed
	Isobornyl Cyclohexanol		1 kg.	1	Gum Turpentine Oil	1.582 kg.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

kg.|1|Gum Turpentine Oil|1.582 kg.| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Case No.	54 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	CALYX CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004168AM25
RA File Number	03AX04004042 AM25
Licence No and<br>Date	0311038743/18/11/2024
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/May/202526/3 dated 04/06/2025 against advance<br>authorization No. 0311037957 dated 15/10/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Azithromycin Dihydrate<br>1 kg<br>1<br>Azithromycin Amine<br>0.9434 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	55 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	NEOGEN CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004178AM25
RA File Number	03AX04004070 AM25
Licence No and<br>Date	0311038776/18/11/2024
Norms Committee Decision:

3/ MEET/ Jun/ 202526/ 5 and 30/06/2025| |HQ File Number|HQRNORM APPLY 00004178AM25| |RA File Number|03AX04004070 AM25| |Licence No and Date|0311038776/18/11/2024| |Norms Committee Decision:||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/May/202526/3 dated 04/06/2025 against advance authorization No. 0311038044 dated 18/10/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed
Ethyl Isobutyrate	1 kg.	1	Isobutyric Acid	0.948 kg.

Case No.	56 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	STERMONE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004192AM25
RA File Number	34AX04000685 AM25
Licence No and<br>Date	3411005667/18/11/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Complete and Balanced chemical reaction, with molecular weight.<br>1.<br>Percentage yield on molar basis.<br>2.

TE, it was decided to call for following information/documents from the firm:- Complete and Balanced chemical reaction, with molecular weight. 1. Percentage yield on molar basis. 2.||

Case No.	57 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004195AM25
RA File Number	03AX04004115 AM25
Licence No and<br>Date	0311038791/18/11/2024
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and on the basis of<br>information provided by the firm, it was decided to fix ad-hoc norms as under:-<br>Sl. No<br>Export Product<br>Quantity<br>1<br>Medical Cream and Ointment (Erythromycin BPO and Benzoyl Peroxide GeL<br>0.1%/2.5% 23.3 Kit pack Tot Wt : 1165 Kgs (Net Cont: Hyd 77.70Kgs,Car<br>14Kgs, Docu 2.5Kgs, d lim 2.5 Kgs, Alco149.80 Kgs, Ery 1.20 Kgs, Vial 50000<br>nos, Seal 50000 nos, Colts 50000 nos , Jar 50000 nos, RIB 50000))<br>1 Number<br>2<br>Medical Cream and Ointment (Erythromycin BPO and Benzoyl Peroxide GeL<br>0.1%/2.5% 46.6 Gm Kit pack Tot Wt :2330 Kgs (Net Cont: Hyd 155.40 Kgs, Car<br>28 Kgs, Docu 5Kgs ,d lim 5 Kgs, Alco 299.60 Kgs, Ery 2.40 Kgs, Vial 50000 nos,<br>Seal 50000 nos, Colts 50000 nos, Jar 50000 nos, RIB 50000))<br>1 Number<br>**S.

Kgs (Net Cont: Hyd 155.40 Kgs, Car 28 Kgs, Docu 5Kgs ,d lim 5 Kgs, Alco 299.60 Kgs, Ery 2.40 Kgs, Vial 50000 nos, Seal 50000 nos, Colts 50000 nos, Jar 50000 nos, RIB 50000)) 1 Number S. No Import Product Quantity allowed. 1 Relevant Bulk Drugs Net content in the export product plus 2% wastage. 2 Relevant Excipients Net content in the export product plus 2% wastage. 3 Relevant Packaging Material Relevant as per Packing Policy & General Notes. Note: The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption. i. RA concerned may take further necessary action as per above decision of NC.||

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

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

in export to the RA concerned for redemption.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Case No.	58 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004214AM25
RA File Number	05AX04002700 AM25
Licence No and<br>Date	0511029003/19/11/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Detailed justification for the quantitative requirement of packing materials.<br>1.

Case No.	Case No.	59 / NC/3/MEET/Jun/202526/5	59 / NC/3/MEET/Jun/202526/5	59 / NC/3/MEET/Jun/202526/5	59 / NC/3/MEET/Jun/202526/5	59 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00004218AM25
RA File Number		34AX04000699 AM25
Licence No and<br>Date		3411005675/19/11/2024
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/Mar/202324/25 dated 11/03/2024 against advance<br>authorization No.

red 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/202324/25 dated 11/03/2024 against advance authorization No. 34110043 dated 07/11/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Lidocaine USP 50.99 kg. Lidocaine and Prilocaine Cream USP 2.5% and 400000||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Lidocaine and Prilocaine Cream USP 2.5% and||400000|1|Lidocaine USP|50.99 kg.|

Case No.	Case No.	59 / NC/3/MEET/Jun/202526/5	59 / NC/3/MEET/Jun/202526/5	59 / NC/3/MEET/Jun/202526/5	59 / NC/3/MEET/Jun/202526/5	59 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00004218AM25
RA File Number		34AX04000699 AM25
Licence No and<br>Date		3411005675/19/11/2024
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/Mar/202324/25 dated 11/03/2024 against advance<br>authorization No. 34110043 dated 07/11/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol.

/import item in meeting No.NC/3/MEET/Mar/202324/25 dated 11/03/2024 against advance authorization No. 34110043 dated 07/11/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Lidocaine USP 50.99 kg. Lidocaine and Prilocaine Cream USP 2.5% and 400000||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Lidocaine and Prilocaine Cream USP 2.5% and||400000|1|Lidocaine USP|50.99 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

|2.5% 5 gm Tube (Net content of active ingredients 125.00 kgs and 125.00 kgs) Numbers 2 Prilocaine Base USP 50.99 kg. 3 Lidocaine USP 428.39 kg. Lidocaine and Prilocaine Cream USP 2.5% and 2.5% 30 gm tube (Net content of active ingredients 862.500 kgs and 862.500 kgs) 560000 Numbers 4 Prilocaine Base USP 428.39 kg. Lidocaine Ointment USP 5% 30 gm tube (Net content of active ingredients 7.5 kgs) 50000 Numbers 5 Lidocaine USP 76.40 kg. Lidocaine Ointment USP 5% 35.44 gm tube (Net content of active ingredients 8.86 kgs) 60000 Numbers 6 Lidocaine USP 108.36 kg. Lidocaine Ointment USP 5% 50 gm jar (Net content of active ingredients 12.50 kgs) 50000 Numbers 7 Lidocaine USP 127.40 kg. RA concerned may take furt

2.5% 5 gm Tube (Net content of active<br>ingredients 125.00 kgs and 125.00 kgs)	Numbers	2	Prilocaine Base USP	50.99 kg.
Lidocaine and Prilocaine Cream USP 2.5% and<br>2.5% 30 gm tube (Net content of active<br>ingredients 862.500 kgs and 862.500 kgs)	560000<br>Numbers	3	Lidocaine USP	428.39 kg.
		4	Prilocaine Base USP	428.39 kg.
Lidocaine Ointment USP 5% 30 gm tube (Net<br>content of active ingredients 7.5 kgs)	50000<br>Numbers	5	Lidocaine USP	76.40 kg.
Lidocaine Ointment USP 5% 35.44 gm tube<br>(Net content of active ingredients 8.86 kgs)	60000<br>Numbers	6	Lidocaine USP	108.36 kg.
Lidocaine Ointment USP 5% 50 gm jar (Net<br>content of active ingredients 12.50 kgs)	50000<br>Numbers	7	Lidocaine USP	127.40 kg.

redients 8.86 kgs)|60000 Numbers|6|Lidocaine USP|108.36 kg.| ||Lidocaine Ointment USP 5% 50 gm jar (Net content of active ingredients 12.50 kgs)|50000 Numbers|7|Lidocaine USP|127.40 kg.|

Case No.	60 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	VENUS REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004262AM25
RA File Number	30AX04000446 AM25
Licence No and<br>Date	3011006063/21/11/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Copy of Certificate of Analysis (CoA) of import item from Foreign Supplier.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Case No.	61 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	BVC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004278AM25
RA File Number	34AX04000703 AM25
Licence No and<br>Date	3411005691/21/11/2024

| |Meeting Number and Date|NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025| |HQ File Number|HQRNORM APPLY 00004278AM25| |RA File Number|34AX04000703 AM25| |Licence No and Date|3411005691/21/11/2024| |Norms Committee Decision: The Committee considered the request of the firm for fixation of ad-hoc norms and on the basis of information provided by the firm and it has been observed by the committee that export product “Allyl Amyl Glyolate” (Perfumery Compound) as applied by the firm appears to fall under para 4.11(b) of FTP, 2023, and the said para states that “For export of perfumes, perfumery compounds and various feeding redients containing vitamins, no authorisation shall be issued by Regional Authority under para 4.07 of HBP. The applicant firm is requested to clarify how this application comes under Para 4.07 of HBP, and the RA concerned is also directed to provide their comments on the same.||

Case No.	62 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	BVC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004279AM25
RA File Number	34AX04000704 AM25
Licence No and<br>Date	3411005693/21/11/2024

| |Meeting Number and Date|NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025| |HQ File Number|HQRNORM APPLY 00004279AM25| |RA File Number|34AX04000704 AM25| |Licence No and Date|3411005693/21/11/2024| |Norms Committee Decision: The Committee considered the request of the firm for fixation of ad-hoc norms and on the basis of information provided by the firm and it has been observed by the committee that export product**“Em** Butanoate (Ethyl-2-Methyl-Butyrate)”(Perfumery Compound) as applied by the firm appears to fall under para 4.11(b) of FTP, 2023, and the said para states that “For export of perfumes, perfumery compounds and various feeding redients containing vitamins, no authorisation shall be issued by Regional Authority under para 4.07 of HBP. The applicant firm is requested to clarify how this application comes under Para 4.07 of HBP, and the RA concerned is also directed to provide their comments on the same.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

cted to provide their comments on the same.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Case No.	63 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	AARTI PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004287AM25
RA File Number	03AX04004231 AM25
Licence No and<br>Date	0311038930/22/11/2024
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:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Theophylline (Anhydrous)<br>1 kg.<br>1<br>Cyano Acetic Acid 70%<br>0.89 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Import Items* Qty. allowed. Theophylline (Anhydrous) 1 kg. 1 Cyano Acetic Acid 70% 0.89 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	64 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	SPAR PHARMA LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004288AM25
RA File Number	09AX04000741 AM25
Licence No and<br>Date	0911008449/22/11/2024
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/Apr/202526/1 dated 25/04/2025 against advance<br>authorization No. 0911006814 dated 21/02/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Export Product	Qty.	Sl.<br>No.	Import Items<br>	Qty. allowed.
4-Fluoro-alpha-[2-methyl-1-<br>oxopropyl]-gamma-oxo-N-beta-<br>diphenyl<br>benzene<br>butanamide<br>(Solid)	<br>1 kg.	1	Aniline Oil (Liquid)	0.47 kg.
		2	Fluorobenzene (Liquid)	0.52 kg.
		3	Acetone (Liquid)	0.50 kg.
		4	Methyl Aceto Acetate (Liquid)	1.06 kg.
		5	Iso Butyryl Chloride (Liquid)	0.97 kg.

g.|1|Aniline Oil (Liquid)|0.47 kg.| |||2|Fluorobenzene (Liquid)|0.52 kg.| |||3|Acetone (Liquid)|0.50 kg.| |||4|Methyl Aceto Acetate (Liquid)|1.06 kg.| |||5|Iso Butyryl Chloride (Liquid)|0.97 kg.|

Case No.	Case No.	65 / NC/3/MEET/Jun/202526/5	65 / NC/3/MEET/Jun/202526/5	65 / NC/3/MEET/Jun/202526/5	65 / NC/3/MEET/Jun/202526/5	65 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00004290AM25
RA File Number		05AX04002802 AM25
Licence No and<br>Date		0511029111/22/11/2024
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:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Senticort (Budesonide Nebuliser<br>1 Number<br>1<br>Budisonide Ph.Eur<br>0.525 mg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Senticort (Budesonide Nebuliser		1 Number	1	Budisonide Ph.Eur	0.525 mg.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

iser||1 Number|1|Budisonide Ph.Eur|0.525 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Suspension 0.5 mg / 2 mL<br>Suspension) in 3 ml Ampoule<br>Senticort (Budesonide Nebuliser<br>Suspension 1.0 mg / 2mL<br>Suspension) in 3 ml Ampoule<br>1 Number<br>2<br>Budisonide Ph.Eur<br>1.05 mg.<br>RA concerned may take further necessary action as per above decision of NC.	Suspension 0.5 mg / 2 mL<br>Suspension) in 3 ml Ampoule
	Senticort (Budesonide Nebuliser<br>Suspension 1.0 mg / 2mL<br>Suspension) in 3 ml Ampoule	1 Number	2	Budisonide Ph.Eur	1.05 mg.

Case No.	66 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	MAC-CHEM PRODUCTS (INDIA) PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004291AM25
RA File Number	03AX04004099 AM25
Licence No and<br>Date	0311038941/22/11/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Copy of Drug Manufacturing License (DML) with approved composition of export item.<br>1.<br>Copy of Master Batch Formula.<br>2.<br>Vial size in ml.<br>3.<br>Wastage claimed.<br>4.

the firm:- Copy of Drug Manufacturing License (DML) with approved composition of export item. 1. Copy of Master Batch Formula. 2. Vial size in ml. 3. Wastage claimed. 4.||

Case No.	67 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	AKSHAY INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004292AM25
RA File Number	31AX04000218 AM24

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Licence No and Date

3111004111/22/11/2024

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. Chloral 1 kg. 1 Denatured Ethyl Alcohol 0.375 kg. Ethyl Chloride 1 kg. 2 Denatured Ethyl Alcohol 0.833 kg. RA concerned may take further necessary action as per above decision of NC.

r>1 Denatured Ethyl Alcohol 0.375 kg. Ethyl Chloride 1 kg. 2 Denatured Ethyl Alcohol 0.833 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	68 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	ASTA BIOCHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
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 case is under consideration and TE was requested to expedite his comments.

Case No.	69 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004302AM25
RA File Number	05AX04002820 AM25

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Licence No and 0511029128/22/11/2024 Date 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/Apr/202526/2 dated 08/05/2025 against advance authorization No. 0511014976 dated 23/09/2022, 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:-

nst advance authorization No. 0511014976 dated 23/09/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Tobramycin Inhalation Solution,<br>300 mg / 5ml (Having net<br>content of 98.82 kg of Bulk drug<br>(filling volume 5.4 ml in each<br>number))	1 Number Pack	1	Tobramycin USP	315 mg./Vial

Case No.	70 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	MOREPEN LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
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 case is under consideration and TE was requested to expedite his comments.

Case No.	71 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
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.

|RA File Number|34AX04000689 AM25| |Licence No and Date|3411005705/22/11/2024| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	72 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	WEST BENGAL CHEMICAL INDUSTRIES LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004317AM25
RA File Number	02AX04000534 AM25
Licence No and<br>Date	0211007647/22/11/2024
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/May/202526/3 dated 04/06/2025 against advance<br>authorization No. 0211007515 dated 28/10/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed<br>Ferric Maltol<br>1 kg.<br>1<br>Maltol<br>0.962 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	73 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	ADCOCK INGRAM LIMITED

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Deferred| |Party Name|ADCOCK INGRAM LIMITED|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004318AM25
RA File Number	07AX04001351 AM25
Licence No and<br>Date	0711012875/22/11/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	Case No.	74 / NC/3/MEET/Jun/202526/5	74 / NC/3/MEET/Jun/202526/5	74 / NC/3/MEET/Jun/202526/5	74 / NC/3/MEET/Jun/202526/5	74 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00004321AM25
RA File Number		03AX04004113 AM25
Licence No and<br>Date		0311038981/24/11/2024
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/May/202526/3 dated 04/06/2025 against advance<br>authorization No. 0311022935 dated 19/04/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Tylosin Bolus 200 mg.

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. Tylosin Bolus 200 mg. ((Each Bolus Contains Tylosin 200mg) 1 Number 1 Tylosin Tartrate 204.00 mg. Tylosin Injection 5% - 50 ml. ((Each Ml Contains Tylosin Tartrate Eq. To Tylosin Base 50mg) 1 Number 2 Tylosin Tartrate 3.056 gm. Tylosin Injection 5% - 100 ml. ((Each Ml Contains Tylosin Tartrate Eq. To Tylosin Base 50mg) 1 Number 3 Tylosin Tartrate 6.111 gm.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Tylosin Bolus 200 mg. ((Each Bolus Contains Tylosin 200mg)||1 Number|1|Tylosin Tartrate|204.00 mg.| ||Tylosin Injection 5% - 50 ml. ((Each Ml Contains Tylosin Tartrate Eq. To Tylosin Base 50mg)||1 Number|2|Tylosin Tartrate|3.056 gm.| ||Tylosin Injection 5% - 100 ml. ((Each Ml Contains Tylosin Tartrate Eq. To Tylosin Base 50mg)||1 Number|3|Tylosin Tartrate|6.111 gm.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

50mg)||1 Number|3|Tylosin Tartrate|6.111 gm.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Tylosin Ta<br>ml. ((Each	rtrate Injection 20% - 50<br>Ml Contains Tylosin	1 Number	4	Tyl	12.222 gm.
<br>Tartrate Eq. To Tylosin 200mg)
Tylosin Tartrate Injection 20%-100<br>ml. ((Each Ml Contains Tylosin<br>Tartrate Eq. To Tylosin 200mg)		1 Number	5	Tylosin Tartrate	24.444 gm.
Tylosin Tartrate Powder 100% -100<br>gm. Sachet ((Each Gram Contains<br>Tylosin Tartrate 100%)		1 Number	6	Tylosin Tartrate	101 gm.
Tylosin Tartrate Powder 100% - 500<br>gm. Sachet ((Each Gram Contains<br>Tylosin Tartrate 100%)		1 Number	7	Tylosin Tartrate	505 gm.
Tylosin Tartrate Powder 100% -1 kg<br>Jar ((Each Gram Contains Tylosin		1 Number	8	Tylosin Tartrate	1010 gm.
Tartrate 100	%)


Tylosin Tartr	ate Powder 20% -5 gm.	1 Number	9	Tylosin Tartrate	1.1756 gm.
((Each Gram	Contains Tylosin Tartrate
Eq. To Tylos	in 20%)

Tli Tt	t Pd 20% 100	<br>1 Nb	10	Tli Ttt	23513
yosn arrae ower - gm.<br>((Each Gram Contains Tylosin Tartrate<br>Eq. To Tylosin 20%)		<br> <br>umer		yosn arrae	. gm.
Tylosin Tartrate Powder 20% - 500<br>		1 Number	11	Tylosin Tartrate	117.564 gm.
gm. ((Each Gram Contains Tylosin<br>Tartrate Eq.

e Eq. To Tylosin 20%)||| umer||yosn arrae||. gm.| |||Tylosin Tartrate Powder 20% - 500 |||1 Number|11|Tylosin Tartrate||117.564 gm.| |||gm. ((Each Gram Contains Tylosin Tartrate Eq. To Tylosin 20%)|||||||| ||||||||||| |||Tylosin Tartr ||ate Powder 20% -1kg Jar | 1 Number|12|Tylosin Tartrate||235.128 gm.| |||((Each Gram E T Tl||Contains Tylosin Tartrate i 20%|||||| |||q. o yos||n )|||||| ||||||||||| |||Tylosin Tartr||ate Powder 99% - 100|1 Number|13|Tylosin Tartrate||100 gm.| |||gm Sachet ((||Each Gram Contains|||||| |||Tylosin Tartr||ate 99%)||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Tylosin Tartrate Powder 99% - 500	1 Number	14	Tylosin Tartrate	500 gm.
gm Sachet ((Each Gram Contains
Tylosin Tartrate 99%)
Tylosin Tartrate Powder 99% -1 kg Jar	<br>1 Number	15	Tylosin Tartrate	1000 gm.
((Each Gram Contains Tylosin Tartrate
99%)
Tylosin Tartrate Bolus 600 mg ((Each	1 Number	16	Tylosin Tartrate	612 mg.
Bolus Contains Tylosin Tartrate 600
mg)

te|1000 gm.| |((Each Gram Contains Tylosin Tartrate||||| |99%)||||| |Tylosin Tartrate Bolus 600 mg ((Each|1 Number|16|Tylosin Tartrate|612 mg.| |Bolus Contains Tylosin Tartrate 600||||| |mg)|||||

Case No.<br>75 / NC/3/MEET/Jun/202526/5	Case No.<br>75 / NC/3/MEET/Jun/202526/5
Case Status<br>Case Approved
Party Name<br>VINS BIOPRODUCTS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number<br>HQRNORM APPLY 00004340AM25
RA File Number<br>09AX04000743 AM25
Licence No and<br>Date<br>0911008471/25/11/2024
Norms Committee Decision:
The Committee considered the case as per agenda		and taking cue from the earlier decision for same export
product/import item in meeting No.NC/3/MEET/Mar/202425/18 dated 17/03/2025 against advance
authorization No. 0911004801 dated 10/04/2023,			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.
Tetanus Antitoxin I.H.S / B.P	1,00,000		1	Tetanus Antitoxin 2500 I.U / ml	69.3 Liter
1500 IU / ML Plus [overage of	Vials
150 IU in addition] in PFS / vials /
Ampoule) [733333 Vials]

titoxin I.H.S / B.P|1,00,000||1|Tetanus Antitoxin 2500 I.U / ml|69.3 Liter|| |1500 IU / ML Plus [overage of|Vials|||||| |150 IU in addition] in PFS / vials /||||||| |Ampoule) [733333 Vials]|||||||

Case No.<br>75 / NC/3/MEET/Jun/202526/5	Case No.<br>75 / NC/3/MEET/Jun/202526/5
Case Status<br>Case Approved
Party Name<br>VINS BIOPRODUCTS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number<br>HQRNORM APPLY 00004340AM25
RA File Number<br>09AX04000743 AM25
Licence No and<br>Date<br>0911008471/25/11/2024
Norms Committee Decision:
The Committee considered the case as per agenda		and taking cue from the earlier decision for same export
product/import item in meeting No.NC/3/MEET/Mar/202425/18 dated 17/03/2025 against advance
authorization No. 0911004801 dated 10/04/2023,			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.
Tetanus Antitoxin I.H.S / B.P	1,00,000		1	Tetanus Antitoxin 2500 I.U / ml	69.3 Liter
1500 IU / ML Plus [overage of	Vials
150 IU in addition] in PFS / vials /
Ampoule) [733333 Vials]

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

als /||||||| |Ampoule) [733333 Vials]|||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Case No.	76 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004342AM25
RA File Number	09AX04000768 AM25
Licence No and<br>Date	0911008474/25/11/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	Case No.	77 / NC/3/MEET/Jun/202526/5	77 / NC/3/MEET/Jun/202526/5	77 / NC/3/MEET/Jun/202526/5	77 / NC/3/MEET/Jun/202526/5	77 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00004352AM25
RA File Number		08AX04001406 AM25
Licence No and<br>Date		0811013327/26/11/2024
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/Mar/202324/26 dated 22/03/2024 against advance<br>authorization No. 0811010470 dated 09/01/2024, 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.

9/01/2024, 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. Cinnarizine and Dimenhydrinate Micronized 1 Number 1 40.80 mg /Tablet||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Cinnarizine and||1 Number|1|Dimenhydrinate Micronized|40.80 mg /Tablet|

Case No.	Case No.	77 / NC/3/MEET/Jun/202526/5	77 / NC/3/MEET/Jun/202526/5	77 / NC/3/MEET/Jun/202526/5	77 / NC/3/MEET/Jun/202526/5	77 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00004352AM25
RA File Number		08AX04001406 AM25
Licence No and<br>Date		0811013327/26/11/2024
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/Mar/202324/26 dated 22/03/2024 against advance<br>authorization No. 0811010470 dated 09/01/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

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. Cinnarizine and Dimenhydrinate Micronized 1 Number 1 40.80 mg /Tablet||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Cinnarizine and||1 Number|1|Dimenhydrinate Micronized|40.80 mg /Tablet|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Dimenhydrinate 20 Mg + 40 PH.EUR Mg Tablets (Cinzator) (Each Uncoated Tablets Contains: Cinnarizine Ph. Eur. 20 Mg & 40 Mg Dimenhydrinate Ph. Eur. 40 Mg Net content of Dimenhydrinate should not be less than 293.530 Kgs in export product)

Case No.	Case No.	78 / NC/3/MEET/Jun/202526/5	78 / NC/3/MEET/Jun/202526/5	78 / NC/3/MEET/Jun/202526/5	78 / NC/3/MEET/Jun/202526/5	78 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		GALAXY SURFACTANTS LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00004373AM25
RA File Number		03AX04004236 AM25
Licence No and<br>Date		0311039071/27/11/2024
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/May/202526/3 dated 04/06/2025 against advance<br>authorization No.

ered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/May/202526/3 dated 04/06/2025 against advance authorization No. 0311032511 dated 26/03/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Phenol 0.690 kg. Phenoxyethanol 1 kg. 2 Ethylene Oxide 0.325 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Phenoxyethanol||1 kg.|1|Phenol|0.690 kg.| |||||2|Ethylene Oxide|0.325 kg.| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Case No.	79 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004377AM25
RA File Number	08AX04001410 AM25
Licence No and<br>Date	0811013343/27/11/2024
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:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>**Qty.

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. Loratadine Tablets -10 Mg (Pollentyme Tablets 10 Mg) (Each Film Coated Sustained Release Tablet Contains: Loratadine Tablets. Net Content of Active Ingredient Loratadine should not be less than 15.000 Kgs.) 1 Number 1 Loratadine (Micronised) 10.20 mg/Tablet RA concerned may take further necessary action as per above decision of NC.||

Case No.	80 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	INDO AMINES LIMITED
Meeting Number	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

and Date
HQ File Number	HQRNORM APPLY 00004382AM25
RA File Number	03AX04004287 AM25
Licence No and<br>Date	0311039086/27/11/2024
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/Apr/202526/1 dated 25/04/2025 against advance<br>authorization No.0311037167 dated 16/09/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Sorbitol 70% Solution 0.71 kg. Sorbitan Mono Laurate or IAL SML 1 kg. 2 Distilled Coconut Fatty Acid (95% Active Content) 0.66 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	81 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	NEOGEN CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004386AM25
RA File Number	03AX04004293 AM25
Licence No and<br>Date	0311039087/27/11/2024
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/May/202526/3 dated 04/06/2025 against advance<br>authorization No. 0311038044 dated 18/10/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Export Product	Qty.	Sl. No.	Import Items	Qty. Allowed.
Ethyl Isobutyrate	1 kg.	1	Isobutyric Acid	0.948 kg.

ation: DGFT(HQ)

UDIN00246597AM26

Export Product	Qty.	Sl. No.	Import Items	Qty. Allowed.
Ethyl Isobutyrate	1 kg.	1	Isobutyric Acid	0.948 kg.

Case No.	82 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	HARMONY ORGANICS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004392AM25
RA File Number	31AX04000298 AM25
Licence No and<br>Date	3111004132/28/11/2024
Norms Committee Decision:<br>The Committee considered the request of the firm for fixation of ad-hoc norms and on the basis of<br>information provided by the firm and it has been observed by the committee that export product“Hexyl<br>Salicylate”(Perfumery Compound) as applied by the firm appears to fall under para 4.11(b) of FTP,<br>2023, and the said para states that “For export of perfumes, perfumery compounds and various feeding<br>redients containing vitamins, no authorisation shall be issued by Regional Authority under para 4.07 of<br>HBP. The applicant firm is requested to clarify how this application comes under Para 4.07 of HBP, and<br>the RA concerned is also directed to provide their comments on the same.

para 4.07 of HBP. The applicant firm is requested to clarify how this application comes under Para 4.07 of HBP, and the RA concerned is also directed to provide their comments on the same.||

Case No.	83 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	APOTHECARY PHARMACEUTICALS PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004393AM25
RA File Number	31AX04000245 AM25
Licence No and Date	3111004133/28/11/2024
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

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

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

Export Product	Qty.	Sl.<br>No.	Import Items	Qty. allowed.
FLORFENICOL Veterinary Oral<br>Liquid 30% w/v	<br>10000 Liters	1	FLORFENICOL<br>(MIN. 98%)	3060 kg.

oduct**	Qty.	Sl.<br>No.	Import Items	Qty. allowed.
FLORFENICOL Veterinary Oral<br>Liquid 30% w/v	<br>10000 Liters	1	FLORFENICOL<br>(MIN. 98%)	3060 kg.

Case No.	Case No.	84 / NC/3/MEET/Jun/202526/5	84 / NC/3/MEET/Jun/202526/5	84 / NC/3/MEET/Jun/202526/5	84 / NC/3/MEET/Jun/202526/5	84 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		MANKIND PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00004398AM25
RA File Number		05AX04002902 AM25
Licence No and<br>Date		0511029281/28/11/2024
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:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Timolol Maleate Ophthalmic<br>Solution, USP 0.25% (5 mL)<br>(filling volume 5.3 ml in each<br>number)<br>1 Number<br>1<br>Timolol Maleate USP<br>17.34 mg.<br>Timolol Maleate Ophthalmic<br>Solution, USP 0.25% (10 mL)<br>(filling volume 10.5 ml in each<br>1 Number<br>2<br>Timolol Maleate USP<br>34.68 mg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

almic Solution, USP 0.25% (10 mL) (filling volume 10.5 ml in each 1 Number 2 Timolol Maleate USP 34.68 mg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Timolol Maleate Ophthalmic Solution, USP 0.25% (5 mL) (filling volume 5.3 ml in each number)||1 Number|1|Timolol Maleate USP|17.34 mg.| ||Timolol Maleate Ophthalmic Solution, USP 0.25% (10 mL) (filling volume 10.5 ml in each||1 Number|2|Timolol Maleate USP|34.68 mg.|

Case No.	Case No.	84 / NC/3/MEET/Jun/202526/5	84 / NC/3/MEET/Jun/202526/5	84 / NC/3/MEET/Jun/202526/5	84 / NC/3/MEET/Jun/202526/5	84 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		MANKIND PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00004398AM25
RA File Number		05AX04002902 AM25
Licence No and<br>Date		0511029281/28/11/2024
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:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Timolol Maleate Ophthalmic Solution, USP 0.25% (5 mL) (filling volume 5.3 ml in each number) 1 Number 1 Timolol Maleate USP 17.34 mg. Timolol Maleate Ophthalmic Solution, USP 0.25% (10 mL) (filling volume 10.5 ml in each 1 Number 2 Timolol Maleate USP 34.68 mg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Timolol Maleate Ophthalmic Solution, USP 0.25% (5 mL) (filling volume 5.3 ml in each number)||1 Number|1|Timolol Maleate USP|17.34 mg.| ||Timolol Maleate Ophthalmic Solution, USP 0.25% (10 mL) (filling volume 10.5 ml in each||1 Number|2|Timolol Maleate USP|34.68 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

ch||1 Number|2|Timolol Maleate USP|34.68 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

number)<br>Timolol Maleate Ophthalmic<br>Solution, USP 0.5% (5 mL) (filling<br>volume 5.3 ml in each number)<br>1 Number<br>3<br>Timolol Maleate USP<br>34.68 mg.<br>Timolol Maleate Ophthalmic<br>Solution, USP 0.5% (10 mL)<br>(filling volume 10.5 ml in each<br>number)<br>1 Number<br>4<br>Timolol Maleate USP<br>69.36 mg.<br>RA concerned may take further necessary action as per above decision of NC.	number)
	Timolol Maleate Ophthalmic<br>Solution, USP 0.5% (5 mL) (filling<br>volume 5.3 ml in each number)	1 Number	3	Timolol Maleate USP	34.68 mg.
	Timolol Maleate Ophthalmic<br>Solution, USP 0.5% (10 mL)<br>(filling volume 10.5 ml in each<br>number)	1 Number	4	Timolol Maleate USP	69.36 mg.

Case No.	Case No.	85 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00004399AM25
RA File Number		09AX04000703 AM25
Licence No and<br>Date		0911008500/28/11/2024
	<br>ate	0911008500/28/11/2024

25||||||| |HQ File Number|||HQRNORM APPLY 00004399AM25||||||| |RA File Number|||09AX04000703 AM25||||||| |Licence No and Date|||0911008500/28/11/2024||||||| || ate||0911008500/28/11/2024||||||| |N |orms Commi|ttee Decision:|||||||xport vance 07 of| ||The Commi product/imp |ttee considered the case as per agenda and taking cue from ort item in meeting No.NC/3/MEET/Mar/202122/15 d |||||the earlier decision for same e ated 17/03/2022 against ad ||| ||authorizatio HBP Vol. I|n No. 0911000062 dated 23/12/2020, it was decided to fix as per details given below or as applied by the firm, whiche|||||ad-hoc norms under Para 4. ver is less:-||| ||||||||||| ||Exort Pr|oduct||Qt|Sl No|Imort Ite|ms|Qt allowe|d.| ||p|||y.|. .|p||y.|| ||Cefoperazone + Sulbactam|||1 Number|1|Cefoperazone Sodium and||2205 gra|| || powder for solution of | preparation for intravenous and || || Sulbactam Sterile| Sodium (1:1)|.|| ||intramuscular administration 1g + 1g|||||||||

d||2205 gra|| || powder for solution of | preparation for intravenous and || || Sulbactam Sterile| Sodium (1:1)|.|| ||intramuscular administration 1g + 1g|||||||||

Case No.	Case No.	Case No.	85 / NC/3/MEET/Jun/202526/5	85 / NC/3/MEET/Jun/202526/5	85 / NC/3/MEET/Jun/202526/5	85 / NC/3/MEET/Jun/202526/5	85 / NC/3/MEET/Jun/202526/5	85 / NC/3/MEET/Jun/202526/5	85 / NC/3/MEET/Jun/202526/5
Case Status			Case Approved
Party Name			JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number			HQRNORM APPLY 00004399AM25
RA File Number			09AX04000703 AM25
Licence No and<br>Date			0911008500/28/11/2024
	<br>ate		0911008500/28/11/2024
N<br> <br> <br> <br>	orms Commi	ttee Decision:							xport<br>vance<br>07 of
	The Commi<br>product/imp<br>	ttee considered the case as per agenda and taking cue from<br>ort item in meeting No.NC/3/MEET/Mar/202122/15 d<br>					the earlier decision for same e<br>ated 17/03/2022 against ad<br>
	authorizatio<br>HBP Vol. I	n No. 0911000062 dated 23/12/2020, it was decided to fix<br>as per details given below or as applied by the firm, whiche					ad-hoc norms under Para 4.<br>ver is less:-

	Exort Pr	oduct		Qt	Sl No	Imort Ite	ms	Qt allowe	d.
	p			y.	**.

s applied by the firm, whiche|||||ad-hoc norms under Para 4. ver is less:-||| ||||||||||| ||Exort Pr|oduct||Qt|Sl No|Imort Ite|ms|Qt allowe|d.| ||p|||y.|. .|p||y.|| ||Cefoperazone + Sulbactam|||1 Number|1|Cefoperazone Sodium and||2205 gra|| || powder for solution of | preparation for intravenous and || || Sulbactam Sterile| Sodium (1:1)|.|| ||intramuscular administration 1g + 1g|||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Case No.	86 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	RUBICON RESEARCH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004445AM25
RA File Number	03AX04004271 AM25
Licence No and<br>Date	0311039180/29/11/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Copy of Master-Batch Formula showing net content of each input in the export, in each case.

the advice of the TE, it was decided to call for following information/documents from the firm:- Copy of Master-Batch Formula showing net content of each input in the export, in each case.||

Case No.	Case No.	87 / NC/3/MEET/Jun/202526/5	87 / NC/3/MEET/Jun/202526/5	87 / NC/3/MEET/Jun/202526/5	87 / NC/3/MEET/Jun/202526/5	87 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00004448AM25
RA File Number		05AX04002908 AM25
Licence No and<br>Date		0511029328/29/11/2024
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/Mar/202425/19 dated 27/03/2025 against advance<br>authorization No. 3411004545 dated 29/01/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

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

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

1<br>Ciprofloxacin<br>25.475 mg.<br>Ciprofloxacin and<br>Dexamethasone Sterile Otic<br>Suspension 7.5ml ((Each ml<br>contains Ciprofloxacin 3 mg.<br>& Dexamethasone 1mg<br>(Equivalent to 14625.000 Gm.<br>Ciprofloxacin and 4875.000<br>Gm. Dexamethasone Bulk<br>Drug))<br>1 Number<br>2<br>Dexamethasone (Micronised)<br>7.65 mg.<br>RA concerned may take further necessary action as per above decision of NC.	Ciprofloxacin and<br>Dexamethasone Sterile Otic<br>Suspension 7.5ml ((Each ml<br>contains Ciprofloxacin 3 mg.<br>& Dexamethasone 1mg<br>(Equivalent to 14625.000 Gm.<br>Ciprofloxacin and 4875.000<br>Gm. Dexamethasone Bulk<br>Drug))	1 Number	1	Ciprofloxacin	25.475 mg.
			2	Dexamethasone (Micronised)	7.65 mg.

Case No.	Case No.	88 / NC/3/MEET/Jun/202526/5	88 / NC/3/MEET/Jun/202526/5	88 / NC/3/MEET/Jun/202526/5	88 / NC/3/MEET/Jun/202526/5	88 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		VINCIT LABS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00004500AM25
RA File Number		05AX04002854 AM25
Licence No and<br>Date		0511029349/02/12/2024

and Date||NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025||||| |HQ File Number||HQRNORM APPLY 00004500AM25||||| |RA File Number||05AX04002854 AM25||||| |Licence No and Date||0511029349/02/12/2024||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/May/202526/3 dated 04/06/2025 against advance authorization No. 0511025080 dated 19/04/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Levofloxacin Q Acid or Levofloxacin Carboxylic Acid 0.856 kg. Levofloxacin Hemihydrate 1 kg. 2 N Methyl Piperazine 0.432 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Levofloxacin Hemihydrate||1 kg.|1|Levofloxacin Q Acid or Levofloxacin Carboxylic Acid|0.856 kg.| |||||2|N Methyl Piperazine|0.432 kg.| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

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.<br>No.	Import Items	Qty. allowed.
Tenoxicam Injection 20 mg / 2 ml<br>Vial (Yellow Lyophilized Mass<br>Filled In Clear Glass Vials)	1 Number	1	Tenoxicam BP<br>(Yellow Crystalline<br>Powder )	22 mg/Vial

Case No.	Case No.	96 / NC/3/MEET/Jun/202526/5	96 / NC/3/MEET/Jun/202526/5	96 / NC/3/MEET/Jun/202526/5	96 / NC/3/MEET/Jun/202526/5	96 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		VACHICHEM INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00004590AM25
RA File Number		07AX04001389 AM25
Licence No and<br>Date		0711012984/06/12/2024
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/Sep/202425/9 dated 10/10/2024 against advance<br>authorization No. 0711005637 dated 09/11/2022, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of 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. 6-(2-Propeny)-Ergoline-8- Carboxylic Acid Lysergol (9,10 Didehydro 6 Methylergoline -8B-Methanol 1 kg. 1 2.98 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||6-(2-Propeny)-Ergoline-8- Carboxylic Acid||1 kg.|1|Lysergol (9,10 Didehydro 6 Methylergoline -8B-Methanol|2.98 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

CAS No. 81409-74-7 CAS No .602-85-7

Case No.	97 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004593AM25
RA File Number	07AX04001402 AM25
Licence No and<br>Date	0711012997/06/12/2024
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/Apr/202526/1 dated 25/04/2025 against advance<br>authorization No. 0711010591 dated 21/02/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Citric Acid 0.500 kg. 2 Dl-Malic Acid 0.477 kg. Calcium Citrate Malate USP 1 kg. 3 Calcium Carbonate 0.720 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No. 98 / NC/3/MEET/Jun/202526/5

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Case Status	Case Deferred
Party Name	S KANT CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004594AM25
RA File Number	03AX04004339 AM25
Licence No and<br>Date	0311039398/06/12/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	99 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	INNOVARE LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004600AM25
RA File Number	09AX04000824 AM25
Licence No and<br>Date	0911008548/06/12/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

|RA File Number|09AX04000824 AM25| |Licence No and Date|0911008548/06/12/2024| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	100 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	KLJ PLASTICIZERS LIMITED.
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004615AM25
RA File Number	05AX04002962 AM25
Licence No and<br>Date	0511029473/09/12/2024
Norms Committee Decision:<br>The committee considered the request of firm for rfixation 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>Which specific Dibasic Acid (Carbon Chain) is imported, if it is combination of various Dibasic Acid

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

then percentage of each Dibasic Acid.

Case No.	101 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	NAVIN FLUORINE ADVANCED SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004621AM25
RA File Number	03AX04004517 AM25
Licence No and<br>Date	0311039431/09/12/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

|RA File Number|03AX04004517 AM25| |Licence No and Date|0311039431/09/12/2024| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	102 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004634AM25
RA File Number	09AX04000770 AM25
Licence No and<br>Date	0911008566/09/12/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	103 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004636AM25
RA File Number	09AX04000736 AM25

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Licence No and 0911008567/09/12/2024 Date 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. 0911007698 dated 06/08/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

st advance authorization No. 0911007698 dated 06/08/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Aztreonam for Injection USP<br>1 Gram	1 Number	1	Aztreonam and Arginine	1.10 gm.
Aztreonam for Injection USP<br>500 mg	1 Number	2	Aztreonam and Arginine	0.55 gm.

Case No.	104 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	MOREPEN LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004639AM25
RA File Number	05AX04003091 AM25
Licence No and<br>Date	0511029509/09/12/2024
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/Mar/202425/19 dated 27/03/2025 against advance<br>authorization No.0511025590 dated 17/05/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

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

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
8-Chloro-6, 11-Dihydro -11(1-<br>Methyl-4-Piperidinylidene)-5H<br>benzo (5,6) Cyclohepta (1,2-B)<br>Pyridine (LH09)	1 kg.	1	3-Chloro Benzyl Cyanide	1.37 kg.
		2	Sodium Methoxide	0.54 kg.
		3	Toluene	3.74 kg.
		4	N,N-Dimethyl Carbamoyl<br>Chloride	0.68 kg.
		5	Methanol	0.47 kg.
		6	Tetrahydrofuran	2.41 kg.

hloro Benzyl Cyanide|1.37 kg.| ||||2|Sodium Methoxide|0.54 kg.| ||||3|Toluene|3.74 kg.| ||||4|N,N-Dimethyl Carbamoyl Chloride|0.68 kg.| ||||5|Methanol|0.47 kg.| ||||6|Tetrahydrofuran|2.41 kg.|

Case No.	Case No.	105 / NC/3/MEET/Jun/202526/5	105 / NC/3/MEET/Jun/202526/5	105 / NC/3/MEET/Jun/202526/5	105 / NC/3/MEET/Jun/202526/5	105 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		FREESIA CHEMICALS
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00004641AM25
RA File Number		03AX04004323 AM25
Licence No and<br>Date		0311039458/09/12/2024
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/Mar/202324/26 dated 22/03/2024 against advance<br>authorization No. 0311029806 dated 01/01/2024, 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.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

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

Case No.	Case No.	105 / NC/3/MEET/Jun/202526/5	105 / NC/3/MEET/Jun/202526/5	105 / NC/3/MEET/Jun/202526/5	105 / NC/3/MEET/Jun/202526/5	105 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		FREESIA CHEMICALS
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00004641AM25
RA File Number		03AX04004323 AM25
Licence No and<br>Date		0311039458/09/12/2024
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/Mar/202324/26 dated 22/03/2024 against advance<br>authorization No. 0311029806 dated 01/01/2024, 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.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Cyclopentanone	1 kg	1	Adipic Acid	1.93 kg.
(CAS No. 120-92-3)

FT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Cyclopentanone	1 kg	1	Adipic Acid	1.93 kg.
(CAS No. 120-92-3)

Case No.	106 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004643AM25
RA File Number	03AX04004331 AM25
Licence No and<br>Date	0311039465/10/12/2024
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/Mar/202324/18 dated 17/03/2025 against advance<br>authorization No. 0311028487 dated 04/11/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Acetic Acid (Glacial)<br>1218000 kg.<br>N-Propyl Acetate<br>2000000 kg.<br>2<br>N-Propanol<br>1210000 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	107 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

2526/5| |---|---| |Case Status|Case Deferred|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Party Name		NAVIN FLUORINE ADVANCED SCIENCES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00004650AM25
RA File Number		03AX04004531 AM25
Licence No and<br>Date		0311039468/10/12/2024
Norms Committee	Decision:
The committee	considered the request of firm for rfixation of ad-hoc norms and as per the advice of the
TE, it was decided to call for following information/documents from the firm:-
Commercial value of Low Boiler and High Boiler.<br>1.
Justification of low Yield i.e. 68%.<br>2.

Case No.<br>108 / NC/3/MEET/Jun/202526/5
Case Status<br>Case Approved
Party Name<br>JUBILANT GENERICS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number<br>HQRNORM APPLY 00004656AM25
RA File Number<br>05AX04003055 AM25
Licence No and<br>Date<br>0511029526/10/12/2024
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import item in meeting No.NC/3/MEET/Mar/202425/5 dated 30/06/2025 against advance
authorization No. 0511029526 dated 10/12/2024, it was decided to fix ad-hoc norms under Para 4.07 of
HBP Vol.

rt item in meeting No.NC/3/MEET/Mar/202425/5 dated 30/06/2025 against advance|||| |authorization No. 0511029526 dated 10/12/2024, 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.|| |Amantadine HCL Tablet 100 mg 1 Number 1 Amantadine|102|mg/100 mg Tablet|| |Hydrochloride|||| |RA concerned may take further necessary action as per above decision of NC.||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Case No.	109 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	CADCHEM LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004662AM25
RA File Number	30AX04000476 AM25
Licence No and<br>Date	3011006185/10/12/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

|RA File Number|30AX04000476 AM25| |Licence No and Date|3011006185/10/12/2024| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	110 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	SAPTAGIR LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004668AM25
RA File Number	09AX04000826 AM25
Licence No and<br>Date	0911008582/10/12/2024
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advice of<br>the TE, it was decided to call for following information/documents from the firm:-<br>Manufacturing Process in detail indicating Chemistry Molecular Weight and Percentage Yield

Case No.	111 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	UNIMAX CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

e|NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

HQ File Number	HQRNORM APPLY 00004669AM25
RA File Number	03AX04004566 AM25
Licence No and<br>Date	0311039500/10/12/2024
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/May/202526/3 dated 04/06/2025 against advance<br>authorization No.0311037957 dated 15/10/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Azithromycin Dihydrate<br>1 kg.<br>1<br>Azithromycin Amine<br>0.9434 kg.<br>RA concerned may take further necessary action as per above decision of NC.

o. Import Items** Qty. allowed. Azithromycin Dihydrate 1 kg. 1 Azithromycin Amine 0.9434 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	112 / NC/3/MEET/Jun/202526/5	112 / NC/3/MEET/Jun/202526/5	112 / NC/3/MEET/Jun/202526/5	112 / NC/3/MEET/Jun/202526/5	112 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		MALIK LIFESCIENCES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00004671AM25
RA File Number		05AX04002960 AM25
Licence No and<br>Date		0511029432/10/12/2024
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/May/202526/3 dated 04/06/2025 against advance<br>authorization No.0511028020 dated 22/10/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Cefixime Tablets 200 mg (Each tablet<br>Cefixime USP<br>1 Number<br>1<br>204 mg/Tablet
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Cefixime Tablets 200 mg (Each tablet		1 Number	1	Cefixime USP	204 mg/Tablet

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

lets 200 mg (Each tablet||1 Number|1|Cefixime USP|204 mg/Tablet|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

contains Cefixime USP (as Trihydrate<br>equivalent to Cefixime 200 mg on<br>anhydrous basis))<br>(as Triydrate)<br>Cefixime Tablets 100 mg (Each tablet<br>contains Cefixime USP (as Trihydrate<br>equivalent to Cefixime 100 mg on<br>anhydrous basis))<br>1 Number<br>2<br>Cefixime USP<br>(as Triydrate)<br>102 mg/Tablet<br>RA concerned may take further necessary action as per above decision of NC.	contains Cefixime USP (as Trihydrate<br>equivalent to Cefixime 200 mg on<br>anhydrous basis))			(as Triydrate)
	Cefixime Tablets 100 mg (Each tablet<br>contains Cefixime USP (as Trihydrate<br>equivalent to Cefixime 100 mg on<br>anhydrous basis))	1 Number	2	Cefixime USP<br>(as Triydrate)	102 mg/Tablet

Case No.	113 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	PRIVI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004678AM25
RA File Number	03AX04004547 AM25
Licence No and<br>Date	0311039510/11/12/2024
Norms Committee Decision:<br>The firm was initially granted an Advance Authorisation for the export product_‘Galaxmusk_<br>_Pure’_under Para 4.07 of the Handbook of Procedures (HBP).

510/11/12/2024| |Norms Committee Decision: The firm was initially granted an Advance Authorisation for the export product_‘Galaxmusk_ _Pure’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. Such products are mandatorily required to be processed under Para 4.06 of the HBP. The Committee provided the firm an opportunity for a Personal Hearing on 24.06.2025 in case of other authorization for same export product to clarify and establish that the product ‘Galaxmusk Pure’_does not fall under the said restricted category . During the Personal Hearing, the firm failed to provide a satisfactory explanation or furnish credible supporting evidence to demonstrate that the product in question does not fall under the category of perfume or perfumery compound as defined in Para 4.11(b) of the FTP. Accordingly, after due consideration of the facts of the case, the submissions made, and the relevant provisions of the FTP and HBP, the Committee has decided as under:||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

The request for fixation of norms under Para 4.07 of the HBP for the product ‘Galaxmusk Pure’ is hereby rejected and the RA shall ensure that the authorisation is regularized by payment of applicable Customs duty and interest.

ara 4.07 of the HBP for the product** ‘Galaxmusk Pure’ is hereby rejected and the RA shall ensure that the authorisation is regularized by payment of applicable Customs duty and interest.

Case No.	114 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	CALYX CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004680AM25
RA File Number	03AX04004595 AM25
Licence No and<br>Date	0311039513/11/12/2024
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/May/202526/3 dated 04/06/2025 against advance<br>authorization No.0311037957 dated 15/10/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Artemether<br>1 kg.<br>1<br>Artemisinin<br>1.04 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	115 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	KLJ PLASTICIZERS LIMITED.
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004695AM25
RA File Number	05AX04002980 AM25
Licence No and	0511029585/12/12/2024

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Date 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. 0511025589 dated 17/05/2024, 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
Di-Ethyl Maleate (DEM)	1 Kg.	1	Maleic Anhydride	0.67 Kg.
		2	Denatured Ethyl Alcohol	0.65 Kg.

Export Product	Qty.	Sl. No.	Import Items	Qty. Allowed
Di-Ethyl Maleate (DEM)	1 Kg.	1	Maleic Anhydride	0.67 Kg.
		2	Denatured Ethyl Alcohol	0.65 Kg.

Case No.<br>116 / NC/3/MEET/Jun/202526/5	Case No.<br>116 / NC/3/MEET/Jun/202526/5
Case Status<br>Case Approved
Party Name<br>DIVI'S LABORATORIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number<br>HQRNORM APPLY 00004696AM25
RA File Number<br>09AX04000834 AM25
Licence No and<br>Date<br>0911008583/12/12/2024
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import item in meeting No.NC/3/MEET/Mar/202425/19 dated 27/03/2025 against advance
authorization No. 0911007722 dated 09/08/2024, it was decided to fix ad-hoc norms		under Para 4.07 of
HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty. allowed.
1<br>Iopamidol (Powder)<br>1 kg.	Atipa Di Chloride (Solid)	1.27 kg.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

br>1 kg.|Atipa Di Chloride (Solid)|1.27 kg.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

2	Dim	ethyl F	ormamide (Liquid)	0.68 kg.
3	N N	Dimet	hyl Acetamide (Liquid)	1.46 kg.
4	Nitr	ometha
			ne (Liquid)	0.48 kg.
5	L La	ctic Ac	id (Solid)	0.67 kg.


Case No		117 / NC/3/MEET/Jun/202526/5
.
Case Status		Case Approved

Party Name		ANNORA PHARMA PRIVATE LIMITED

Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025

HQ File Number		HQRNORM APPLY 00004700AM25

RA File Number		09AX04000833 AM25

Licence No and<br>Date		0911008599/12/12/2024

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/Mar/202425/19 dated 27/03/2025 against advance<br>authorization No. 0911007832 dated 29/08/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol.

ort item in meeting No.NC/3/MEET/Mar/202425/19 dated 27/03/2025 against advance authorization No. 0911007832 dated 29/08/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Sodium Sulfate USP(Sodium sulphates: Disodium sulphate) 17.85 gm. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 17.5g/3.13g / 1.6 g per 6 Ounce, ((Each 6-ounce bottle contains,Sodium Sulfate Potassium Sulfate (Sulphates; 1 Number Bottle 2 3.193 gm.|||||||||| ||||||||||| ||Export Product|||Qty.|**Sl. No. **|I|mport Items||Qty. allowed.| ||Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 17.5g/3.13g / 1.6 g per 6 Ounce, ((Each 6-ounce bottle contains,Sodium Sulfate 1|||Number Bottle|1|S s|odium Sulfate USP(Sod ulphates: Disodium sulphate)|ium| 17.85 gm.| ||||||||||| ||||||P 2||otassium Sulfate (Sulpha|tes; 3.193 gm.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

USP 17.5 g Potassium Sulfate		Alums;<br>Peroxosulphates
3.13 g Magnesium Sulfate USP		(Persulphates) - Other)
1.6g))
	3	Magnesium Sulfate USP (Other	<br>1.632 gm.
		sulphates: of magnesium)

Peroxosulphates|| |---|---|---|---|---| |3.13 g Magnesium Sulfate USP|||(Persulphates) - Other)|| |1.6g))||||| |||3|Magnesium Sulfate USP (Other| 1.632 gm.| ||||sulphates: of magnesium)||

Case No.	118 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	RUBICON RESEARCH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004702AM25
RA File Number	03AX04004563 AM25
Licence No and<br>Date	0311039546/12/12/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	119 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	SALVI CHEMICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004747AM25
RA File Number	03AX04004578 AM25
Licence No and<br>Date	0311039577/13/12/2024
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: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

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

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Case No.	Case No.	120 / NC/3/MEET/Jun/202526/5	120 / NC/3/MEET/Jun/202526/5	120 / NC/3/MEET/Jun/202526/5	120 / NC/3/MEET/Jun/202526/5	120 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		ABBOTT HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00004784AM25
RA File Number		03AX04004537 AM25
Licence No and<br>Date		0311039639/16/12/2024
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/Mar/202425/19 dated 27/03/2025 against advance<br>authorization No. 0311030266 dated 18/01/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

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 Fenofibrate Micronized IH/Ph Eur 147.90 mg. Fenofibrate 145mg tablets) ( 68785000 Nos) (Net Content:1) 10073.426 KGS 2) 10013.032 KGS 3) (Indi):2031.909 KGS 4) (Indi):198.789 KGS 5) (Indi):691.289 KGS 6) (Indi):8985.385 KGS 7) (Indi):5857.043 KGS 8) (Indi):5136.864 KGS9) (Indi): 61.907 KGS 10) (Indi): 2042.56 KGS) 1 Number 2 Sucrose PH.Eur (exepient) 146.45 mg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Fenofibrate 145mg tablets) ( 68785000 Nos) (Net Content:1) 10073.426 KGS 2) 10013.032 KGS 3) (Indi):2031.909 KGS 4) (Indi):198.789 KGS 5) (Indi):691.289 KGS 6) (Indi):8985.385 KGS 7) (Indi):5857.043 KGS 8) (Indi):5136.864 KGS9) (Indi): 61.907 KGS 10) (Indi): 2042.56 KGS)||1 Number|1|Fenofibrate Micronized IH/Ph Eur| 147.90 mg.| |||||2|Sucrose PH.Eur (exepient)|146.45 mg.| |||||per above decision of NC.|||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

146.45 mg.| |||||per above decision of NC.|||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26



Cas	e No.	121 / NC/	3/MEET/J	un/202526/5
Cas	e Status	Case Defe	rred
Par	ty Name	SALVI C	HEMICA	L INDUSTRI	ES LIMITED
Me<br>and	eting Number<br>Date	NC/ 3/ M	EET/ Jun/
				202526/ 5 an	d 30/06/2025
HQ	File Number	HQRNOR	M APPL	Y 00004814A	M25
RA	File Number	03AX040	04624 AM	25
Lic<br>Dat	ence No and<br>e	03110396	63/16/12/	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>Copy of Drug Manufacturing License for the export item.<br>1.<br>Complete and Balanced Chemical reactions, with Molecular Weight and percentage yield on molar basis.<br>2.<br>Copy of Certificate of Analysis (CoA) of export item.<br>3.	ms Committee Decision:<br>e committee considere<br>, it was decided to call<br>Copy of Drug Manufa<br>1.<br>Complete and Balanc<br>2.<br>C f Ctifit<br>3		d the req<br>for follo<br>cturing Li<br>ed Chemic<br>f Al	f fi	f fii f dh d	h di f h
				uest o r<br>wing inform	or xaton o a-oc norms an as per<br>ation/documents from the firm:-	te avce o te
				cense for the<br>al reactions,<br>i (CA)	export item.<br>with Molecular Weight and percentage yield on<br>f t it	molar basis.

as per ation/documents from the firm:-|te avce o te| |||||cense for the al reactions, i (CA)|export item. with Molecular Weight and percentage yield on f t it|molar basis.| ||||||||

Case No.	122 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	SALVI CHEMICAL INDUSTRIES LIMITED

Meeting Number
<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004815AM25
RA File Number	03AX04004626 AM25
Licence No and
<br>Date	0311039664/16/12/2024
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:-<br>Copy of Drug Manufacturing License for the export item.<br>I.<br>Complete and Balanced Chemical reactions, with Molecular Weight and percentage yield on molar basis.<br>II.<br>Co of Certificate of Analsis (CoA) of exort item<br>III
py y p .<br>.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

of exort item III|| |py y p . .||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26




Case No.		123 / NC/3/MEET/Jun/202526/5

Case Status		Case Approved
Party Name		ASHISH LIFE SCIENCE PRIVATE LIMITED

Meeting Number<br>		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
and Date

HQ File Number		HQRNORM APPLY 00004830AM25
RA File Number		03AX04004728 AM25

Licence No and<br>Date		0311039683/17/12/2024
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/Mar/202425/19 dated 27/03/2025 against advance
authorization No. 0311033874 dated 15/05/2024, 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:-

	Export Produ	ct	Qty.	Sl. No.	Import Items	**Qty.

orms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||||||| |||||||| ||Export Produ|ct|Qty.|**Sl. No. **|Import Items|Qty. allowed.| |||||||| |||||||| ||Ashoxy 5 Hydrochloride|% (Oxytetracycline Injection 50 mg) 50| 1 Number|1|PROPYLENE GLYCOL|39.52 gm/Vial| ||ml vial|||||| |||||||| |||||||| ||Ashoxy 5 Hydrochloride|% (Oxytetracycline Injection 50 mg) 100| 1 Number|2|PROPYLENE GLYCOL|79.04 gm/Vial| || ml via|||||| ||Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50 mg) 250 ml vial|| 1 Number|3|PROPYLENE GLYCOL|197.60 gm/Vial| |||||||| ||Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50 mg) 500 ml vial|| 1 Number|4|PROPYLENE GLYCOL|395.20 gm/Vial| |||||||| ||Ah 10|% (Ottli| 1 Nb|5|PROPYLENE GLYCOL|35256 /Vil| ||soxy Injection 100| xyeacyce mg) 50 ml vial| ue|||. ga| |||||||| |||||||| ||Ashoxy 10 |% (Oxytetracycline | 1 Number|6|PROPYLENE GLYCOL|70.512 gm/Vial| ||Injection 100|mg) 100 ml vial||||| ||||||||

eacyce mg) 50 ml vial| ue|||. ga| |||||||| |||||||| ||Ashoxy 10 |% (Oxytetracycline | 1 Number|6|PROPYLENE GLYCOL|70.512 gm/Vial| ||Injection 100|mg) 100 ml vial||||| ||||||||




Case No.		123 / NC/3/MEET/Jun/202526/5

Case Status		Case Approved
Party Name		ASHISH LIFE SCIENCE PRIVATE LIMITED

Meeting Number<br>		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
and Date

HQ File Number		HQRNORM APPLY 00004830AM25
RA File Number		03AX04004728 AM25

Licence No and<br>Date		0311039683/17/12/2024
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/Mar/202425/19 dated 27/03/2025 against advance
authorization No. 0311033874 dated 15/05/2024, 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:-

	Export Produ	ct	Qty.	Sl. No.	Import Items	**Qty.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

||Injection 100|mg) 100 ml vial||||| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Ashoxy<br>10%<br>(Oxytetracycline<br>Injection 100 mg) 250 ml vial	<br>1 Number	7	PROPYLENE GLYCOL	176.28 gm/Vial
PAN Ashoxy 3% (Oxytetracycline<br>Injection 30 mg) 100 ml vial	<br>1 Number	8	PROPYLENE GLYCOL	70.512 gm/Vial
Ashoxy 20% LA (Oxytetracycline<br>Dihydrate<br>Injection<br>eq<br>Oxytetracycline 200 mg) 50 ml vial	<br> <br>1 Number	9	PROPYLENE GLYCOL	9.00 gm/Vial
Ashoxy 20% LA (Oxytetracycline<br>Dihydrate<br>Injection<br>eq<br>Oxytetracycline 200 mg) 100 ml vial	<br> <br>1 Number	10	PROPYLENE GLYCOL	18.00 gm/Vial
Ashoxy 20% LA (Oxytetracycline<br>Dihydrate<br>Injection<br>eq<br>Oxytetracycline 200 mg) 250 ml vial	<br> <br>1 Number	11	PROPYLENE GLYCOL	45.00 gm.Vial
Ashiver 1% (Ivermectin 10 Mg<br>Injection) 10ml vial	<br>1 Number	12	PROPYLENE GLYCOL	10.40 gm/Vial
Ashiver 1% (Ivermectin 10 Mg<br>Injection) 50 ml vial	<br>1 Number	13	PROPYLENE GLYCOL	52.00 gm/Vial
Ashiver 1% (Ivermectin 10 Mg<br>Injection) 100ml vial	<br>1 Number	14	PROPYLENE GLYCOL	104.00 gm/Vial
Ashiver 1% (Ivermectin 10 Mg<br>Injection) 250 ml vial	<br>1 Number	15	PROPYLENE GLYCOL	260.00 gm/Vial
Ashiver 1% (Ivermectin 10 Mg<br>Injection) 500 ml vial	<br>1 Number	16	PROPYLENE GLYCOL	520.00 gm/Vial
Ashiver Forte (Ivermectin 10 mg and<br>Clorsulon 100 mg Injection) 50 ml<br>vial	<br> <br>1 Number	17	PROPYLENE GLYCOL	50.96 gm/Vial

n) 500 ml vial| 1 Number|16|PROPYLENE GLYCOL|520.00 gm/Vial| ||Ashiver Forte (Ivermectin 10 mg and Clorsulon 100 mg Injection) 50 ml vial| 1 Number|17|PROPYLENE GLYCOL|50.96 gm/Vial| ||Ashiver Forte (Ivermectin 10 mg and Clorsulon 100 mg Injection) 100 ml vial| 1 Number|18|PROPYLENE GLYCOL|101.92 gm/Vial| ||Ashienro 10% (Enrofloxacin| 1 Number|19|PROPYLENE GLYCOL|5.20 gm/Vial|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Injection	100 mg) 50 ml vial	100 mg) 50 ml vial
Ashienro	<br>10%<br>(Enrofloxacin			<br>1 Number	20	PROPYLENE GLYCOL	10.40 gm/Vial
Injection	100 mg) 100 ml vial
Ashienro	<br>10%<br>(Enrofloxacin			<br>1 Number	21	PROPYLENE GLYCOL	26.00 gm/Vial
Injection	100 mg) 250 ml vial
Ashityl	20%	<br>(Tylosin	Tartrate	<br>1 Number	22	PROPYLENE GLYCOL	10.40 gm/Vial
injection	eq to	Tylosin 200	mg) 50
ml viaL
Ashityl	20%	<br>(Tylosin	Tartrate	<br>1 Number	23	PROPYLENE GLYCOL	20.80 gm/Vial
injection	eq to	Tylosin 200	mg) 100
ml vial
Ashityl	20%	<br>(Tylosin	Tartrate	<br>1 Number	24	PROPYLENE GLYCOL	52.00 gm/Vial
injection	eq to	Tylosin 200	mg) 250
ml vial
Ashityl	5%	(Tylosin	Tartrate	<br>1 Number	25	PROPYLENE GLYCOL	10.40 gm/Vial
injection	eq to	Tylosin 50 mg) 50 ml
vial
Ashital 10% (Closantel 10%			Inj) 100	<br>1 Number	26	PROPYLENE GLYCOL	55.12 gm/Vial
ml vial

5|PROPYLENE GLYCOL|10.40 gm/Vial| |injection|eq to|Tylosin 50 mg) 50 ml|||||| |vial|||||||| |Ashital 10% (Closantel 10%|||Inj) 100| 1 Number|26|PROPYLENE GLYCOL|55.12 gm/Vial| |ml vial||||||||

Case No.	124 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	SALVI CHEMICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004840AM25
RA File Number	03AX04004600 AM25
Licence No and	0311039713/17/12/2024

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Date

Norms Committee Decision:

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

Copy of Drug Manufacturing License for the export item.
Complete and Balanced Chemical reactions, with Molecular Weight and percentage yield on molar basis.
Copy of Certificate of Analysis (CoA) of export item.

Case No.	Case No.	125 / NC/3/MEET/Jun/202526/5	125 / NC/3/MEET/Jun/202526/5	125 / NC/3/MEET/Jun/202526/5	125 / NC/3/MEET/Jun/202526/5	125 / NC/3/MEET/Jun/202526/5	125 / NC/3/MEET/Jun/202526/5	125 / NC/3/MEET/Jun/202526/5	125 / NC/3/MEET/Jun/202526/5	125 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		HEMA DYECHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00004850AM25
RA File Number		52AX04000282 AM25
Licence No and<br>Date		5211011126/17/12/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. Allowed. 4 Chloro 2-5 Dimethoxy Aniline 1 kg. 1 Para Dimethoxy Benzene 0.982 kg. RA concerned may take further necessary action as per above decision of NC.||||||||||| |||||||||||| ||Export Product|||Qty.|Sl.|No.|Imp|ort Items||Qty. Allowed.| |||||||||||| ||4 Chloro 2-5 Dimethoxy Aniline|||1 kg.|1||Para|Dimethoxy Benzene||0.982 kg.| ||concerned may take further necessary|||action as per||above dec||ision of NC.||| |||||||||||| |||||||||||| |Cas|e No.|126 / NC/3/MEET/Jun/202||526/5||||||| |Cas|e Status|Case Approved||||||||| |Par|ty Name|COVALENT LABORAT||ORIES PRIVAT||E LIMITE||D||| |Me|eting Number|NC/ 3/ MEET/ Jun/ 20252||6/ 5 and 30/06/2||025||||| ||||||||||||

Case No.	126 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	COVALENT LABORATORIES PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

r|NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

and Date
HQ File Number	HQRNORM APPLY 00004856AM25
RA File Number	09AX04000854 AM25
Licence No and<br>Date	0911008628/17/12/2024
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/Mar/202425/19 dated 27/03/2025 against advance<br>authorization No. 0911007730 dated 13/08/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>7-Phenylacetamideo-3-<br>Chloromethyl Cephalosporonic Acid<br>Para Methoxybenzyl Ester (GCLE)<br>2.672 kg.<br>2<br>Acetone<br>8.85 kg.<br>3<br>Methylene Chloride<br>5.70 kg.<br>4<br>Methanol<br>5.70 kg.<br>5<br>Activated Carbon<br>0.100 kg.<br>7-AMINO-3-VINYL-3-<br>CEPHEM-4-CARBOXYLIC<br>ACID (7-AVCA) (API)<br>1 kg.<br>6<br>Triphenyl Phosphine<br>1.26 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	127 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025

Case No.	127 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

HQ File Number	HQRNORM APPLY 00004857AM25
RA File Number	09AX04000845 AM25
Licence No and<br>Date	0911008629/17/12/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	128 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	HEMA DYECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004868AM25
RA File Number	03AX04004730 AM25
Licence No and<br>Date	0311039736/18/12/2024
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>4 Chloro 2-5 Dimethoxy Aniline<br>1 Kg.<br>1<br>Para Dimethoxy Benzene<br>0.982 Kg.<br>RA concerned may take further necessary action as per above decision of NC.

Items** Qty. Allowed. 4 Chloro 2-5 Dimethoxy Aniline 1 Kg. 1 Para Dimethoxy Benzene 0.982 Kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	129 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	JUBILANT INGREVIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004895AM25
RA File Number	05AX04003211 AM25

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Licence No and Date

0511029723/19/12/2024

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:- To give balance chemical reaction indicating molecular weight of all the reactants and product with stage wise yield of the reaction/ 1. Process flow charts indicating where Alumino Silicate Catalyst, Denatured Ethyl Alcohol and Methanol are used in the chemical reaction giving their application/use. 2. Calculation of the requirekment of all the chemicals with justification of low yield. 3.

Ethyl Alcohol and Methanol are used in the chemical reaction giving their application/use. 2. Calculation of the requirekment of all the chemicals with justification of low yield. 3.||

Case No.	130 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004896AM25
RA File Number	03AX04004760 AM25
Licence No and<br>Date	0311039753/19/12/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	131 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	KLJ PETROPLAST LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004898AM25
RA File Number	05AX04003186 AM25
Licence No and<br>Date	0511029729/19/12/2024
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/Mar/202425/19 dated 27/03/2025 against DGFT (HQ)

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

File No.NORMREVIW00006341AM25, 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:-

UDIN00246597AM26

File No.NORMREVIW00006341AM25, 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
Di-Ethyl Phthalate (DEP)	1 kg.	1	Phthalic Anhydride	0.700 kg.
		2	Denatured Ethyl Alcohol	0.435 kg.

Case No.	132 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004922AM25
RA File Number	09AX04000851 AM25
Licence No and<br>Date	0911008669/20/12/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	133 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	GRANULES INDIA LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004923AM25
RA File Number	09AX04000869 AM25
Licence No and Date	0911008670/20/12/2024
Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

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.
Bupropion Hydrochloride	1 kg.	1	3 Chloropropiophenone	0.85 kg.

Case No.	134 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	DCM NOUVELLE SPECIALTY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004925AM25
RA File Number	05AX04003062 AM25
Licence No and<br>Date	0511029764/20/12/2024
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>Dibenzylamine<br>1 kg.<br>1<br>Benzonitrile<br>0.6972 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 135 / NC/3/MEET/Jun/202526/5

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

NC.||

Case No. 135 / NC/3/MEET/Jun/202526/5

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Case Status	Case Approved
Party Name	DCM NOUVELLE SPECIALTY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004926AM25
RA File Number	05AX04003061 AM25
Licence No and<br>Date	0511029765/20/12/2024
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>Dibenzylamine<br>1 kg.<br>1<br>Benzonitrile<br>0.6972 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	136 / NC/3/MEET/Jun/202526/5
Case Status	Case Deferred
Party Name	SALVI CHEMICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004930AM25
RA File Number	03AX04004652 AM25
Licence No and<br>Date	0311039796/20/12/2024

| |Meeting Number and Date|NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025| |HQ File Number|HQRNORM APPLY 00004930AM25| |RA File Number|03AX04004652 AM25| |Licence No and Date|0311039796/20/12/2024| |Norms Committee Decision: The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE, it was decided to call for following information/documents from the firm:- Copy of Drug Manufacturing License for the export item. i. Complete and Balanced Chemical reactions, with Molecular Weight and percentage yield on molar basis. ii. Copy of Certificate of Analysis (CoA) of export item. iii.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Case No.	Case No.	137 / NC/3/MEET/Jun/202526/5	137 / NC/3/MEET/Jun/202526/5	137 / NC/3/MEET/Jun/202526/5	137 / NC/3/MEET/Jun/202526/5	137 / NC/3/MEET/Jun/202526/5
Case Status		Case Approved
Party Name		USV PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number		HQRNORM APPLY 00004931AM25
RA File Number		03AX04004696 AM25
Licence No and<br>Date		0311039799/20/12/2024
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||0311039799/20/12/2024||||| |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. Doxycycline Tablets, USP 50 MG 100 S ((21,600 Bottles X 100 Per Bottles = 21,60,000 Tablets) (Total Weight of Export Product = 108.000 Kgs) (Exempts imported input/material weight inclusive of wastage = 116.327 Kgs)) 1 Number 1 Doxycycline USP (Monohydrate) 53.066 mg. Doxycycline Tablets, USP 75 MG 100 S ((2,200 Bottles X 100 Per Bottles = 2,20,000 Tablets) (Total Weight of Export Product = 16.500 Kgs) (Exempts imported input/material weight inclusive of wastage = 17.772 Kgs)) 1 Number 2 Doxycycline USP (Monohydrate) 79.600 mg. Doxycycline Tablets, USP 100 MG 500 S ((9,800 Bottles X 500 Per Bottles = 49.00.000 Tablets) (Total Weight of Export Product = 490.000 Kgs) (Exempts imported input/material weight inclusive of wastage = 527.779 Kgs)) 1 Number 3 Doxycycline USP (Monohydrate) 106.13 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|**Qty.

rial weight inclusive of wastage = 527.779 Kgs)) 1 Number 3 Doxycycline USP (Monohydrate) 106.13 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Doxycycline Tablets, USP 50 MG 100 S ((21,600 Bottles X 100 Per Bottles = 21,60,000 Tablets) (Total Weight of Export Product = 108.000 Kgs) (Exempts imported input/material weight inclusive of wastage = 116.327 Kgs))|| 1 Number|1|Doxycycline USP (Monohydrate)|53.066 mg.| ||Doxycycline Tablets, USP 75 MG 100 S ((2,200 Bottles X 100 Per Bottles = 2,20,000 Tablets) (Total Weight of Export Product = 16.500 Kgs) (Exempts imported input/material weight inclusive of wastage = 17.772 Kgs))||1 Number|2|Doxycycline USP (Monohydrate)|79.600 mg.| ||Doxycycline Tablets, USP 100 MG 500 S ((9,800 Bottles X 500 Per Bottles = 49.00.000 Tablets) (Total Weight of Export Product = 490.000 Kgs) (Exempts imported input/material weight inclusive of wastage = 527.779 Kgs))|| 1 Number|3|Doxycycline USP (Monohydrate)|106.13 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

|Doxycycline USP (Monohydrate)|106.13 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Doxycycline Tablets, USP 100 MG 50 S<br>((98,000 Bottles X 50 Per Bottles =<br>49,00,000 Tablets) (Total Weight of<br>Export Product = 490.000 Kgs) (Exempts<br>imported input/material weight inclusive of<br>wastage = 527.779 Kgs))<br>1 Number<br>4<br>Doxycycline USP<br>(Monohydrate)<br>106.13 mg.<br>RA concerned may take further necessary action as per above decision of NC.	Doxycycline Tablets, USP 100 MG 50 S<br>((98,000 Bottles X 50 Per Bottles =<br>49,00,000 Tablets) (Total Weight of<br>Export Product = 490.000 Kgs) (Exempts<br>imported input/material weight inclusive of<br>wastage = 527.779 Kgs))	<br>1 Number	4	Doxycycline USP<br>(Monohydrate)	106.13 mg.

Case No.	138 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	LEE PHARMA LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004945AM25
RA File Number	09AX04000848 AM25
Licence No and Date	0911008676/20/12/2024
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.

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. Rosuvastatin Calcium 1 kg. 1 Tert.Butyl-( E )-(6[-[4-(4-fluorophenyl)-6- isopropyl-2-(N-methyl Sulfonyl)amino]pyrimidin-5- yl]vinyl](4R,6S)-2,2- Dimethy (tert-Butyl 2-((4R,6S)-6-((E)-2-(4-(4-fluorophenyl)-6- isopropyl-2-(N-methyl methyl sulfonamido) pyrimidin-5-yl) vinyl)-2,2- dimethyl-1,3-Dioxin -4-yl) acetate) 1.30 kg. RA concerned may take further necessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00246597AM26

Case No.	139 / NC/3/MEET/Jun/202526/5
Case Status	Case Approved
Party Name	LEE PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202526/ 5 and 30/06/2025
HQ File Number	HQRNORM APPLY 00004946AM25
RA File Number	09AX04000850 AM25
Licence No and<br>Date	0911008677/20/12/2024
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. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 4-chloro-6-ethyl-5-fluoropyrimidine 3.30 kg. 2 Tetrahydrofuran 20.50 kg. Voriconazole 1 kg. 3 R Camphorsulphonic Acid(L-(-)- Camphorsulfonic Acid) 1.01 kg. RA concerned may take further necessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Aug-2025 11:54:47 Reason: ramankumar@nic.in Location: DGFT(HQ)

Verbatim extracted text (OCR/PDF). Older scans and tables may show extraction artifacts — verify against the original for anything you act on.

Analysis

No analysis generated for this document yet (analysis runs over brief docs + on-demand). Run build_analysis.py --ids 8083 --apply.